data management

profileSiri05
2001VAERSDATA.csv
Home>Information Systems homework help>data management
VAERS_ID RECVDATE STATE AGE_YRS CAGE_YR CAGE_MO SEX RPT_DATE SYMPTOM_TEXT DIED DATEDIED L_THREAT ER_VISIT HOSPITAL HOSPDAYS X_STAY DISABLE RECOVD VAX_DATE ONSET_DATE NUMDAYS LAB_DATA V_ADMINBY V_FUNDBY OTHER_MEDS CUR_ILL HISTORY PRIOR_VAX SPLTTYPE FORM_VERS TODAYS_DATE BIRTH_DEFECT OFC_VISIT ER_ED_VISIT ALLERGIES
0164314 01/02/2001 NC 4.0 4 M 12/21/2000 51/2 x 5 1/2 cm area of erythema and induration around injection site. Y 12/18/2000 12/19/2000 1 NONE PVT PUB NONE NC00101 1
0164315 01/02/2001 MA 11.0 11 F 12/07/2000 Pt developed fever and rash, 4 weeks, post vax, with increased respiratory difficulty; by the 5th week,requiring assisted ventilation. Diagnosed with Varicella pneumonia Y Y 14 Y 10/19/2000 11/21/2000 33 Increased LFT's, decreased platelets PVT PUB zantac, albuterol neb., intal meb. congenital CMV, CP, RAD Congenital CMV, CP, RAD, developmental delay, legally blind 1
0164316 01/02/2001 MN 47.0 47 F 12/22/2000 The pt experienced an asthma attack, difficulty breathing, brought under control with repeated doses of albuterol inhaler. Y Y 12/01/2000 12/01/2000 0 PVT OTH Singulair, Pepcid, Beclovent, Serevent, Vancenase AQ NONE Asthma; benign arachnoid cyst in brain 1
0164317 01/02/2001 AZ 0.6 0 .5 M 08/30/2000 Child became weak (had trouble holding head up) and eyes crossed, 5 days, post vax of 6 month vaccinations of DTP/Hib3 & OPV3. Final dx: Cerebral Palsy. Y Y N 02/22/1995 02/26/1995 4 Scan, metabolic studies and muscle biopsy-all nml PVT OTH Metabolic test at birth was abnormal; T4 & TSH 1
0164318 01/02/2001 MI 1.5 1 .5 F 12/21/2000 The pt experienced seizure-like activity consisting of decreased awareness, symmetrical jerking or tremor over the whole body without breath holding, cyanosis or paleness. This happened during sleep, after she had been asleep about 30 minutes. This happened five days post vax. U 11/29/2000 12/04/2000 5 lumbar puncture, CSF-neg, WBC - 16,800 PVT PVT contact dermatitis infantile acne 1
0164319 01/02/2001 MI 0.75 0 .8 F 12/21/2000 One day post vax the pt began having vomiting once per day and diarrhea of twice a day. She experienced irritability and decreased appetite with slight congestion and respiratory raspiness. She felt warm but no documented fever. She was somewhat crabby or irritable. She had one day of leg pain but no swelling. U 12/13/2000 12/14/2000 1 AST-nml, BUN, TSH, lead level and CBC - pending PVT PVT NONE cough NONE 1
0164320 01/02/2001 NY 64.0 63 F 12/20/2000 4 days post 2nd vax the pt developed face, neck,and eye swelling. The pt's allergist placed her on prednisone. Was unable to go off of prednisone until 10/5/99. The pt was diabetic and had terrible problems. Blood sugar went up to 508, vision problems, lost muscle in legs to the extent that she couldn't go up two steps. If she knelt down to get something off of the floor she couldn't get up. Arms were full of large ecchymosis. The pt was terribly ill for 4 months and then in November her hair started falling out. It has now all grown back but she had to wear wigs for 6-8 months. Missing vaccine information not available. U 06/06/1999 06/10/1999 4 UNK UNK Glyburide, glucophase, synthroid hx of allergy attacks (5 years since last attack), chemical and environmental allergies, smoker, diabetes, hx of breast and thyroid cancer 1
0164321 01/02/2001 NJ 17.0 16 F The pt experienced severe headaches from 5/00 to the present, with fatigue and joint pain. Y N 04/17/2000 05/01/2000 14 PVT UNK NONE allergy to PCN 1
0164322 01/02/2001 WA 0.3 0 .3 M 12/22/2000 2 days post vax the pt became cranky and wanted to be held all the time. Y 10/27/2000 10/29/2000 2 PVT PUB NONE NONE 1
0164323 01/02/2001 MN 0.75 0 .8 M 12/22/2000 The pt experienced bronchitis, cough, congestion, irritability, and decreased appetite. Y Y 12/08/2000 12/10/2000 2 Chest x-ray - nml, lung exam - abn PVT PVT NONE NONE NONE 1
0164324 01/02/2001 47 F 12/20/2000 This patient received the flu vaccine in the left deltoid 11/12/2000. Two days later at the injection site erythematous raised papules appeared, then two weeks later sub Q hematoma 0.5 cm with erythematous papules came and pustules appearing sub Q fluid in concealed collection. Minimal treatment: 4 erythematous raised tender papules 0.2-0.4 cm in size with pustular appearing central area. U 11/13/2000 11/15/2000 2 UNK UNK Diabetes Mellitus, COPD, Native American. 1
0164325 01/02/2001 42.0 M 12/05/2000 This health care worker (physician) experienced an onset of severe unremitting generalized headache, severe head to-toe myalgias, and profound malaise after 24-48 S/P influenza vaccine. The patient has no medical history of note - headache was not positional, hypersensitivity to light, no nausea, vomiting or occular abnormality. No relief with Tylenol. Motrin or sleep. Onset severe myalgia, no muscles spared. Muscles not painful to touch. No dark urine or stool color. Patient reports even "feel" hurts him. Profound malaise, no stamina or endurance. The patient had to run a marathon and the severity of malaise exceeded the weakness S/P the marathon. Denies fever, cough, URTI, and diarrhea. Triad of headaches, myalgias, and fatigue lasted approximately 2 weeks. U 11/16/2000 11/17/2000 1 Recent labs-wnl UNK UNK Beconase, Triamcinolone No allergies, non-smoker,no medical problems 1
0164326 01/02/2001 MA 48.0 48 F 12/21/2000 The patient received her vaccine a 10:30 AM. At 11:30 AM the patient presented to nurse with a mild itchy rash to neck and chest. Progressed rapidly to shortness of breath. The nurse conducted an assessment and treatment was offered and excepted by the patient for an allergic reaction. The patient was injected with Epinephrine and all was called. When the paramedics arrived the patient was still having breathing trouble. They transported the patient to the ER a 11:45. Discharge from the hospital at 3:30. In the evening followed-up with the patient and the patient responded that she was tired but otherwise okay. Y Y 12/18/2000 12/18/2000 0 PUB PVT NONE NONE 1
0164327 01/02/2001 MD 64.0 69 F 12/19/2000 The patient had an occurance of vertigo 57 hours after the flu vaccine was administered. Vertigo still present as of 12/19/00, but improved. Large local reaction on arm persisted for 4 weeks. Y U 11/10/2000 11/13/2000 3 MRI on 11/25/00 OTH PVT NONE Type II diabetic- controlled, Allergic to sulfa and penicillin. ~Influenza (Seasonal) (no brand name)~1~69.00~In Patient 1
0164328 01/02/2001 VA 71.0 71 F 12/11/2000 Approximately 3 hours after injection the patients arm turned red, started swelling, and itching occured approximately 2 days. It was very red from the site of injection to her wrists. Y 12/04/2000 12/04/2000 0 UNK UNK 1
0164329 01/02/2001 MI 61.0 61 F 12/22/2000 The patients left shoulder (deltoid) had erythma, warmth, and swelling. Y Y 12/20/2000 12/20/2000 0 PVT PVT NONE Penicillin 1
0164330 01/02/2001 PA 65.0 65 F 12/20/2000 The patient complains of soreness at injection site. Redness and swelling is also noted. The patient was encouraged to apply a cool pack and alternate with heat. The patient was also encouraged to call MD if symptoms worsen or decreased mobility in limbs. 12/26/00 the patient called and the symptoms subsided, no further problems. Y 12/18/2000 12/18/2000 0 PUB PVT NONE NONE Sinus problems 1
0164331 01/02/2001 VA 52.0 52 M 12/28/2000 The patient had a reaction to the flu shot it was fatigue, and fever for approximately 2 days. Y 12/05/2000 12/05/2000 0 OTH PUB NONE ALLERGIES 1
0164332 01/02/2001 TX 52.0 52 F 12/18/2000 The patient has a rash form the vaccine site upto the right side of his neck and over to the anterior right side of her chest, with pain in the same areas: beginning the next day. Suspect that this is herpes zoster recovering. U 12/11/2000 12/12/2000 1 NONE PUB PUB NONE "crick" in left side of neck Sulfa 1
0164333 01/02/2001 CA 72.0 F Swollen, red rt deltoid 11 cm by 5 cm erythematous. U 12/07/2000 UNK UNK 1
0164334 01/02/2001 FL 13.0 11 F 12/14/2000 Swelling of the left upper arm with redness and tenderness and warmth. Y 12/11/2000 12/11/2000 0 NONE PUB PUB NONE NONE Delayed Puberty 1
0164335 01/02/2001 VA 0.8 0 .8 F 12/22/2000 Fever to 105 Y 12/19/2000 12/19/2000 0 PVT PUB Upper respiratory infection 1
0164336 01/02/2001 NY 50 M 12/23/2000 Dizziness, aches, sweats, chills left arm pain. Y 12/20/2000 12/20/2000 0 PVT UNK Effexor NONE No allergies, positive for depression 1
0164337 01/02/2001 OH 41.0 41 F 12/15/2000 Pt states had a fever of 102F on 12/14/00 with vomiting and diarrhea, muscle ache and shooting pain in right arm (per phone conversation). Did not report for follow-up. U 12/11/2000 12/14/2000 3 PUB PUB Effexor, Ultram, MVI, B Complex, Calcium, ibuprofen, Creatine monohydrate, gingko biloba 1
0164338 01/02/2001 NY 1.3 1 .4 F 12/20/2000 High-grade fever (106F) and irritability 7 days, post vax. which lasted for 4 full days; associated with very poor PO intake and a diffuse morbilliform rash that started during his 2nd day of the high fever. Physical exam revealed no source for the fever. Y Y 12/07/2000 12/14/2000 7 Throat culture PVT UNK NONE NONE 1
0164339 01/02/2001 WI 40.0 0 .1 F 12/26/2000 On 12/15/00, employee was given monovalent measles vaccination for a non-reactive titer drawn as part of post offer physical. On 12/20/00, she came to employee health to report redness and hardness. Redness was approx. 8cm in diameter and induration of 40cm. No fever. Returned on 12/26/00 and area was larger. Recommended 600mg ibuprofen 3 X day and will recheck on 12/29/00. N 12/15/2000 12/17/2000 2 NONE OTH OTH Paxil NONE 1
0164341 01/02/2001 KS 34.0 34 M 12/21/2000 On 12/18/00, pt received TD vaccine and on 12/19/00 he started having migraines, dizziness, sides of head to back of neck, after sneezing. U 12/18/2000 12/19/2000 1 MIL MIL IPPD/Connaught/C00153AA/ID NONE NONE 1
0164342 01/02/2001 WI 1.25 1 .3 M 12/26/2000 Left thigh swelling (entire thigh); not painful; no fever; no treatment prescribed. Y Y 12/21/2000 12/23/2000 2 Thigh measurement PVT PVT Augmentin Otitis Media Otitis Media currently on Augmentin. 1
0164343 01/02/2001 CA 1.0 1 .1 M 12/21/2000 About 1 1/2 hours, post vax, developed red rash around the site of MMR II with welts on lower legs. Disappeared with Benadryl then increased more in area distribution, 16 hours later. Should recover; did with initial Benadryl. U 12/20/2000 12/21/2000 1 PVT PVT NONE Mild eczema 1
0164344 01/02/2001 CA 3.0 3 F 12/16/2000 Pt developed macular rash on trunk and proximal parts of upper and lower extremities, 4 months old. U 12/13/2000 12/16/2000 3 UNK UNK NONE 1
0164345 01/02/2001 PA 33.0 33 F 12/26/2000 Red, swollen and warm to touch. U 12/19/2000 UNK UNK 1
0164346 01/02/2001 NY 40.0 F 12/18/2000 Pt passed out, BP-80/50, had numbness in feet and arms and legs, and tremors. Pt was taken to hospital. Hospital concluded it was an allergic reaction and referred pt to an allergist. Y U 12/18/2000 UNK UNK UNK UNK 1
0164347 01/02/2001 MI 43.0 43 F 11/28/2000 She states "has had nausea every day since injection" but no vomiting and eating as normal. Has occasional dizziness which last for seconds. CC: hair loss. This African/American lady states comb and brush removed large amounts of hair causing her to braid hair and buy a wig 1 week from having injection of Engerix-B. Referred to a Dermatologist for consult. Y U 11/13/2000 11/20/2000 7 UNK UNK PPD test results-neg (given 2 days prior) Quit smoking for some time now; seasonal allergies 1
0164348 01/02/2001 CA 32.0 32 F 12/18/2000 Pt experienced redness, induration, soreness and warmth at site of the injection. Had a fever of 102F and was given Tylenol and didn't decrease with one dose. Given 800mg Motrin and reduced fever to 101F on 12/18/00. Had nausea, vomiting which subsided. Had aches, headache and slight itching. U 12/15/2000 12/15/2000 0 UNK UNK Follow-up for lymphoma. No current treatment. Past CNOP cyclophosphamide, mitoxantrone, (Novantrone), vincristine (Oncovin), and prednisone, 3 months prior. Topical allergy to Betadine, Teyadeim; Lymphoma 1
0166792 01/02/2001 CA 46.0 46 F 01/02/2001 This patient had severe abdominal pain, flu-like discomfort, severity greater on 01/01/01. Unable to sleep due to abdominal pain, and bloating. U 12/27/2000 12/30/2000 3 PUB UNK Tying, Connaught, lot # CR04472, IM, left deltoid. NONE 7 weeks post op; double hernia repair. 1
0164351 01/03/2001 FL 12.0 12 F 12/21/2000 This child received her 3rd Hep-B vaccine on 12/12/00 about 14:30. At 02:00, on 12/15/00, the parents were awakened by the child's cry. They found her limp, unresponsive and gasping for breath. The parents called 911 and started CPR. The child was pronounced dead at the hospital. The parents came in on 12/19/00 and voiced their concern that the death may have been related to the Hep-B vaccine. Follow up information- Report 2001000092-1 describes the death of a 22 year old female who received an injection of hepatitis B vaccine (Engerix-B). The vaccinee was reported to be ab active, healthy child with no known acute or chronic medical conditions. She had no known allergies. There was no history of substance abuse and no family history of stroke, heart diesease, or sudden death. Her height and weight were not known, but she was described as "small for her age". There were no concurrent medications. the vaccinee received her first injection of Engerix B (lot ENG2205A2) on June 01, 2000 and her second injection of Engerix B (lot # ENG3141A2) on July 6, 2000. She had no adverse experiences following receipt of these two injections. She received her third injections of Engerix B on Dec 12, 2000. After receiving the third injection, she reportedly took one tablet of acetaminophen (Tylenol) to prevent local soreness. She was well until approximately 02:00 on Dec 15, 2000, when her parents were awakened by the child's cry. They found her lying in bed limp, unresponsive to verbal stimuli, and gasping for breath. Her eyes were half open. The vaccinee then stopped breathing. Her parents began cardiopulmonary resuscitation and summoned emergency medical personnel. The vacinee was transported by ambulance to the local hospital, where she was pronounced dead on arrival. An autopsy reportedly did not reveal a cause of death, although toxicology results were pending as of Feb 26, 2001. The vaccine provider considers the death to be unrelated to Engerix B administation. The most recent information, received on March 2, 2001, indicated that the childs parents voiced their concern that the death may have been related to the hepatitis B vaccine. The reportr stated that the vaccinee's 13 year old brother received three injections of Engerix B on the same dates, and from the same lots, as his sister. The brother had no adverse experience following receipt or any of the injections. He continued to be well as of Jan 04, 2001. Y 12/15/2000 N 12/12/2000 12/15/2000 3 Autopsy performed/toxicology labs are pending. PUB PUB NONE NONE 20010000821 1
0164352 01/03/2001 NJ 6.0 M 12/28/2000 A mother reported that her 6 year old son received an injection of DTP and subsequently, developed seizures. No further information was available as of the date of this report. Seizures are considered "Medically Important". U UNK OTH OTH UNK UNK Developmental delay NOS HQ5142721DEC2000 1
0164353 01/03/2001 OH 56.0 56 M 11/08/2000 Works at grain elevator across from Health Dept. Employer noticed that he was confused and called his wife who works at the Health Dept, to come get him. She brought him in to have BP checked. His color was slightly flushed. BP was 100/?, then became very pale "diaphoretic" with no complaints of pain. Lowered to the floor, feet elevated on scene. O2 administered per nurse. Pt's main complaint is that he can't remember anything. Was admitted to hospital on the eve of 11/6/00 and discharged on 11/7/00. Y Y Y 11/06/2000 11/06/2000 0 EKG-neg; Cat Scan-neg; Blood work-all neg; Spinal Tap-neg PUB PUB Cardura, Excedrin for headaches Tiredness Hypertension; right inguinal hernia OH0059 1
0164354 01/03/2001 MO 33.0 33 M 12/22/2000 Around 12/7/00, pt developed numbness then 1 week later, he developed weakness in extremities. Pt stated that he was told he has Guillain-Barre. Y Y 11/17/2000 12/07/2000 20 increased protein levels OTH PUB NONE NONE NONE MO2000089 1
0164355 01/03/2001 MA 11.0 F 12/21/2000 Information has been received from a physician concerning an 11 year old female pt who was vaccinated with varicella virus vaccine live and approx. 5 weeks, post vax, presented with a diffuse vesicular rash and respiratory distress requiring hospitalization and intubation. The pt was dx'd with "post vaccine varicella pneumonitis". A respiratory aspirate, as well as BAL fluid specimens were both found to be positive for VZV through the hospital laboratory, however, the physician stated that a number of cultures had been "contaminated with bacteria". The pt is currently improving on acyclovir and is undergoing an "immune work-up". The physician indicated as of 12/12/00, the pt had been extubated. The physician is interested in submitting specimens to a university for PCR analysis. No further information is available. 15-Day follow-up received on 2/7/01 provided no additional data. The follow up received on 7/23/03 indicated that both the bronchioalveolar lavage and the endotracheal secretions specimen were VZV (+). Both specimens were contaminated with bacteria. The presence of Oka/Vaccine VZV was identified by PCR analysis. Further follow-up info from a physician indicated suspicion that the pt has cystic fibrosis with a positive sweat test. "The other reason this was suspected was that the bronchial secretions had an incrreased bacteria load which lead the lab to pursue PCR since they were not able to grow VZV." The physician indicated that "the pt is undergoing an extensive immunologic evaluation." Follow-up info from a physician for the case of hte 11 year old female which indicated that he believes he has discovered a "novel" immune deficiency. Subsequently, the patient's experience was reported in a published article. The patient had recurrent and presumably virus respiratory infections and mental retardation and presented with a 5 day history of an erythematous rash over her trunk and scalp and with diminished activity. Three days before presentation she developed labored breathing, cough and increased respiratory secretions. on the day of admission, she was lethargic, hypothermic, hypoxemic, and had several erythematous papulovesicular lesions over her turnk. Results of the lab studies performed when she was admitted were notable for providing evidence of leukopenia, thrombocytopenia, and elevated serum alanine aminotransferase. Radiography of the patient's chest revealed bilateral symmetric alveolar infiltrates. The patient was admitted to the ICU, and mechanical ventilation was administered. IV acyclovir and methylprednisolone were also admitted. The patient was extubated on hospital day 6 and was discharged on hospital day 17, to complete a 21 day course of acyclovir with follow up at an immunology clinic. It was noted that he patient died 10 months after the reported illness, presumably because of the embolic complications related to a closed fracture of the femur. Results of the analysis of skin lesion smears were positive for VZV, by indirect immunofluorescent assay. An endotracheal tube-aspirate sample was subjected to RFLP analysis and was identified as the Oka vaccine strain. Assessment of the patient's immune system revealed a normal phagocytic and complement function as well as IgG, IgA, and IgM levels that were normal to high, both during her acute illness and recovery. It was noteworthy that the patient had markedly elevated titers of antibodies against several Herpes viridae: CMV specific IgG was > 14 IU/mL but IgM was absent; Epstein Barr virus specific IgG was >19 IU/mL and herpes simplex virus-specific IgG was 1.08 IU/mL. During the patient's acute infection, VZV specific IgG was elevated to 7.51 IU/mL, indicating VZV specific immunity. It was noted that VZV specific lymphocyte proliferation measured 5 months after the patient's disseminated VZV infection revealed appropriate virus specific proliferation. The patient was negative for HIV-1 and -2, by antibody testing, RT PCR for HIV RNA, and culture. Lymphocyte analysis revealed a low to normal absolute lymphocute count during our patient's illness, with an inverted CD4-CD8 ratio that normalized 1 month later. It was noted that the levels of the patient's NKT cells, as measured on the basis of either CD16/CD56/CD3 or CD161/CD3, were abnormally low. Multiple analyses of the patient's PBMC's by flow cytometry revealed a deficiency of CD16/CD56/CD161/CD3 NKT cells in general and a profound deficiency of Valpha24 iNKT cells in particular. It was noted that her immunodeficiency had presented only as a recurrent upper respiratory tract infections; no mention was made of past measles immunization, and she may not have had difficulties with the vaccine. No further info is available. Y Y Y Y N Respiratory aspirate specimen; BAL fluid specimen; PCR analysis present; sweat analysis positive OTH OTH UNK Congenital cytomegalovirus infection WAES00120881 1
0164356 01/03/2001 NY 68.0 M 12/22/2000 Report received from a physician via telephone on 12/19/00, regarding a possible adverse event associated with Fluvirin. A 68 year old male pt received Fluvirin on 12/4/00 and that same day, developed redness around the injection site. On 12/7/00, the rash became generalized all over the pt's body. The pt required hospitalization from 12/10/00 through 12/14/00. On the same day that the pt developed the skin rash, the pt also had started Clindamycin 600mg for an unknown reason. No other information was provided and attempts to obtain further information regarding these events, have been initiated. Y 5 U 12/04/2000 12/04/2000 0 Skin biopsy-showed a skin allergy OTH OTH NONE NONE MPI2000049890 1
0164361 01/03/2001 CA 22.0 M 12/28/2000 It was reported that a male pt received Fluzone SV '00-'01 vaccination on 12/5/00. Approx. 3 days, post vax, pt developed "flu-like" symptoms. Pt was admitted to the hospital on 12/10/00. Pt expired on 12/18/00 and an autopsy was done, results not provided. Further information requested. Autopsy also states patient had headaches, muscle aches, diarrha, nausea, vomiting, fever, cough, sore throat, abdominal pain. Y Y N 12/05/2000 12/08/2000 3 Autopsy-pending UNK UNK U200000993 1
0164362 01/03/2001 TX 2.0 2 .5 M 12/28/2000 It was reported that a 2 year old male pt received a Fluzone SV '00-'01 vaccination on 11/21/00 and reportedly on 12/1/00, the pt developed "left eye tickle", on 12/4/00 he had eye blinking, on 12/6/00, both eyes rolled up to left, on 12/8/00, left side of face twitching and left side of body jerking. On 12/9/00, pt was dx'd with seizure and admitted to the hospital for 1 week. Further information requested. F/U from mailed follow up correspondence rec'd on 7/3/01 it was reported that the pt has not recovered and is still on medication to keep seizures under control. Additional patient and responsible info was also provided. No further info availabel regarding this pt or this case. Y 7 N 11/21/2000 12/01/2000 10 UNK UNK U2000009910 1
0164369 01/03/2001 NY 59.0 58 F 07/03/2002 On 4/19/99, the pt received her 1st Lymerix vaccination with no untoward effects. On 5/19/99, she received her 2nd dose. After 2-3 weeks, she experienced a rash which worsened. The rash was hive-like, ecchymotic, purpuric, burned and was eventually biopsied on 8/24/99. She was dx'd with leucocytoblastic vasculitis and was treated with a shot of cortisone and a 6 day supply of prednisone. After the corticosteroid therapy ended, her condition worsened. She was given prednisone. "In general, she felt more fatigued and had malaise more than usual". She did not improve much but developed joint pain on 9/15/99. She was dx'd with rheumatoid arthritis in 9/99. Prednisone was increased to 60mg/day and hydroxychloroquine 400mg was started. Prednisone was tapered to 20mg/day, hydroxychloroquine was stopped and methotrexate 7.5mg/week was begun on 10/29/99. Her rash returned while on 30mg of prednisone and she still had sever joint pain. The methotrexate was increased to 15mg/week. She still had pain in her knees, ankles, knuckles, wrists, elbows and fingers. A rheumatology consult on 5/12/00, revealed the pt's joint symptoms were improving, but she still had a return of small spots of vasculitis on her arms and legs. The pt reported to the rheumatologist that she was told by a Lyme disease specialist, "she had a vaccine induced vasculitis but the Western Blot suggested Lyme disease as well". The pt was placed on Biaxin 500mg 2X/day. The information received reported the symptoms were ongoing. The adverse event of leucocytoblastic vasculitis is considered "Medically Serious". F/U report revealed degenerative changes most marked C4-5 and C5-6 with disc space narrowing, 3/10/97 MRI revealed herniation of the nucleus pulposus and reversal of the normal lordotic curvature of the spine at C4-5. The chircopracter's diagnosis were cervical subluxation, degeneration of cervical intervertebral disc, cervical sprain/strain, radicultitis. The pt was treated with hot/cold packs, electric muscle stimulation and chiropractic adjusting.F/U over the past year the pt had complained of fatigue, headaches and lightheadedness. F/U On that date epstein-Barr virus (EBV)-VCA Igm titer vas 0.01, EVB+V-VCA IgG titer was 3.14 and EBV nuclear antigen IgG titer was 6.24. The lab reported that these titers were consistent with past infection. That day, a Lyme Elira was 0.09 and a Lyme Igm was 0.07. Medical records from an endocrinologist were rec'd on 4/4/01. On 6/8/99, the pt was seen by an endocrinologist for complaints of fatigue and light headedness associated with nausea, a weight gain of 10 pounds over the past year despite good effort with diet and exercising. preponderance of abdoninal obesity, headaches, mild depression and inability to concetrate. No mention of rash was made by the pt. On exam, the endocrinologist noted that the pt had some mild facial fullness as well as some supraclavicular fullness. There was some slight increase in downy facial hair.. The skin appeared to be of normal texture and temperature. The doctor stated it is my sense that the pt's complaints probably do not have an endocrine basis. However, the pt has enough soft signs and symptoms of cortisol excess to be screened fpr Cushing's syndrome. I have also requested a glucose tolerance test because of the family history of diabetes and ? suggestion that some of these symptoms may be related to hypoglycemia. A dexaathasone suppression test performed 6/11/99 was interpreted as normal. A five hr glucose tolerance test performed 6/22/99 was negative. Medical records were rec'd from the pt's gyn dr on4/4/01. at a 11/7/00 office visit the pt reported tha she had been diagnosed with Lyme disease. At that time, she reported that she was beigh treated with cefuroxima (Ceftin) 1000mg daily. F/U on 12/6/99 the pt reported to her rheumatologist that she had increased hair loss, thinning skin. In addition an old psoriatic lesion was active. Her skin lesions were improving. Her prednisone dosage was decreased from 25mg daily to 22.5 mg daily. The methotrexate dosage was maintained at 15 mg weeksy. The folate dosage was increased from 1mg daily to 2mg daily. 12/29/99 the pt reported that she was experiencing pain in the buttock, which radiated down her leg. She also experienced increased pain in her elbows and knees. She reported that she had consulted chiropractor, she was instructed to take tylenol, apply ice to the affected areas and increase her prednisone dosage if she did not feel better after one day. On 12/30/99 the pt called regarding her prednisone dosage, which was 20 mg daily. She was doing better the dr instructed her to continue to take prednisone 20 mg daly. On 02/11/2002, in a statement of injuries, the vaccinee's attorney alleged that the vaccinee "has been diagnosed with arthritis, and leukocytoclastic vasculitis. She has suffered from moderate to severe joint pain and inflammation in her knuckles, knees, and hip. In addition, she has suffere from rashes, severe fatigue, cognitive difficulties and vision loss, as well as reflux caused by the medications for the above symptoms. The most recent info received on 02/1/2002 did not provide the outcome of the pt. The pt initially reported that she was a non-smoker, medical records indicated that as of 11/30/87, she smoked one pack of cigarettes per day. The medical history included otervcium of the left eye (10/14/98), "severe" dishydrotic eczema. Surgical history included hysterectomy (1983), cholecystectomy (1987), and bilateral carpal tunnel surgery (1991). Follwing the reported onset of vasculitis, the pt experienced seborrheic keratosis with features of solar keratosis on her forehead, granulomatous dermatitis secondary to a ruptured follicular cyst on her right forearm and basal cell carcinoma on her lower back. These events were not reported as adverse events due to vaccine administrations, but were found during the course of review of the pt's medical records. Therefore, they are not listed as adverse events. Concurrent medications included Menalog 80mg IM, cephalaxin 1000 mg daily, Lac-Mydrin lotion, Ultravatel cream, Tenovate, Cordran Topal, Diprolene, Salmaterol and Flvent. The pt was scheduled to be seen by her dermatologist on 06/24/1999; the pt cancelled the appointment. The pt was seen by her dermatologist on 07/13/99 for follow-up of "severe" dishydrotic eczema. At that time, the pt reported that "she has noted increased fragility of her skin on arms and legs which I believe is secondary to systemic steroid treatment." No mention of the hive-like rash, ecchymosis, or purpura was noted in the dermatologist's records. On 08/23/99, the pt's rheumatologist contacted the pt's dermatologist to request that a skin biopsy be performed. The rheumatologist staes he believes the pt was sustaining a cutaneous vasculitis of arms and legs. The pt presented to the dermatologist on 08/24/99. She reported that the vaccine provider had given her an IM injection of Cortisone and a Medrol dosePak on 07/28/99. The dermatolotist performed a 3mm Keyes punch biopsy of the dorsal right forearm. The pathologist's diagnosis was "Subtle small vessel vasculitis with nuclear dust, from right dorsal arm. Note: although these changes are exceptionally subtle, as there is nuclear dust, a tad of fibrin, purpura and a mixed cell infiltrate, this is probably a very early expression of leukocytoclastic vesculitis." On 08/30/99, the pt told the dermatologist that her rheumatologist "placed her on Prednisone 60mg BID and her legs have improved but arms have not. She states the medication is making it impossible for her to sleep an she is having significant joint pains." The pt returned to the dermatologist on 11/30/99. At that time, her prednisone dosage was 25mg daily "She was given Plaquenilf or about one month which was not helpful and on 10/15/99 she was started on MTX which has now been increased to 15mg a week. She is still having problems with sleeping but her joint ain in her ankles are better and she seems t have more energy. She is also on Prilosec. The pt sought a second opinion and was told that everything that we being done for her was correct. All of her blood tests come back completely negative. The only thing she can attribute sher vasculitis to is a Lyme vaccination performed April and May 1999." The pt was examined by her ophthalmologist on 12/10/99 who noted "early cateracts-steroid induced." The pt returned to her dermatologist on 07/25/00 for treatment of dishydrotic eczema, eeborheic karatosis and "body check." The pt stated that "her rheumatoid arthritis got so bad that she had to be in a wheelchair. She states now that after she got the Lyme vaccine she got Lyme disease in September. Her present meds include Methotraxate 2.5mg/week, Ceftin 1000mg QD daily and Bizxin 500mg QD." No mention of leucocytoclastic vasculitis was made at that time. The pt returned to her dermatologist for skin checks on 09/11/00, 09/19/00, 10/02/00, 10/16/00, 11/07/00, 11/14/00 and 11/20/00. No mention of leucocytoclastic vasculitis was made in the dermatologist's office notes on any of those dates. On 09/11/00, the pt told her dermatologist that "overall her health has improved a great deal recently." The most recent info received on 04/29/02 indicated that the rheumatoid arthritis persisted as of 07/25/00 and caused the pt to require the use of a wheelchair. The outcome of the leucocytoclastic vasculitis, Lyme disease, and cataracts were not provided. This report of rheumatoid arthritis is considered disabling because the pt required the use of a wheelchair. The pt saw her gastroenterologist on 09/06/00. He recorded, "Now off Prednisone/methotrexate. Since May and Biaxin/Ceftin for Lyme disease." Y Y N 05/19/1999 06/01/1999 13 Western Blot for Lyme on 3/20/00 was positive for IgG at 18, 41, 45, 58, 66 and 93 kilodalton bands; antinuclear antibody-neg but this was elevated to 8 (<7.5) on 8/23/99. Epstein-Barr virus-IGM-VCA-positive; SGPT-elevated; Bun-elevated; LDH-elevated. F/U X-rays revealed degenerative changes, most marked C4-5 and C5-6.Disc space narrowing in seen at these levels. MRI revealed HNP. Skin biopsy 08/24/99-subtle small vessel vasculitis with nuclear dust, from right dorsal arm. OTH OTH folic acid; Premarin; Prilosec; prednisone; omaprarole; Ammonium lactate; Halobetasol propionate; Clobetasol propionate; Triamcinolone acetonide; Cephalexin; Salmetearol kinafoate; Fluticasone propionate; Flurandrenolone; Botamethasone dipr UNK Foot pain, earache, sinus congestion, sore throat, swollen glands and cough, asthma, high Epstein-Barr titers on 4/19/99, spot on heel dx'd as carpal tunnel disease operated on in 1991, Raynaud's disease since 1991 (after surgery), hiatal hernia, increased bruisability and hypothyroidism. Over the past year, has had fatigue, headaches and light-headedness associated with nausea. 10 pound weight gain, abdominal obesity, ectopic pregnancy, hypoglycemia, hysterectomy. Multiple basal cell carcinoma and tobacco use, chronic sinusitis, constipation, cyst of skin, diathermy of turrinates, diverticulosis, ethmoidectomy, gaze nystagmis, intra-nasal antrostomy, nasal polyp, nasal polype removed, sinus bradycardia, skin cyst removal, angina pectoris, appendectomy, carpal tunnel release, leg weakness 20000368281 1
0164375 01/03/2001 NC 0.75 0 .8 F Pt mom states that 4 hours post vax, pt developed a fever of 103, became lethargic, increased sleeping, irritability and eye drainage. Fever lasted 4 days. Pt was rechecked on 12/20/00. Recommended treatment - observation. U 12/18/2000 12/18/2000 0 PVT PVT NONE NONE NONE 1
0164376 01/03/2001 NY 34.0 34 M 12/12/2000 Pt experienced immediate reaction of nausea, headache, muscle and joint pain with a fever of 100F, lasting approximately 72 hours. Pt had an onset of tendonitis in right elbow approximately 2 weeks - 3 months, treated with rest and an anti-inflammatory. Pt experienced an onset of bilateral carpal tunnel syndrome approximately 6 months to date of report, continued with rest and anti-inflammatory therapy. Y 05/26/1999 05/26/1999 0 NONE OTH PUB NONE NONE fever, nausea~Tetanus Toxoid (no brand name)~1~6.00~In Patient 1
0164377 01/03/2001 CO 0.75 0 .7 M 12/23/2000 Pt developed a rash and a fever one day post vax. Y U 12/22/2000 12/23/2000 1 NONE PUB OTH NONE 1
0164378 01/03/2001 NC 2.0 2 .2 M 12/21/2000 Mother rushed into clinic with child. States her child was sick. Says he received shots yesterday and was having problems breathing and fever today. Child was crying and face was flushed. Temperature was 102.3F (ear). Mother says she did give medicine for temperature X 3. She was referred to MD. Y U 12/20/2000 12/21/2000 1 PUB PUB UNK NONE NONE 1
0164379 01/03/2001 UT 0.8 0 .8 M 12/27/2000 Pt developed a rash 1-2 days post vax that lasted for a couple of weeks. Y 10/25/2000 10/26/2000 1 NONE PVT OTH fluoride; amoxicillin 2 ear infections NONE 1
0164380 01/03/2001 KY 1.08 1 .1 F 12/22/2000 Pt developed a generalized rash and was treated with Benadryl. Y U 12/06/2000 12/20/2000 14 PVT PUB NONE viral exanthem on 12/06/2000 NONE 1
0164381 01/03/2001 CA 0.4 0 .4 F 12/13/2000 Pt developed redness and a bump at injection site. Recommended treatment - warm compresses on immunization site. U 11/30/2000 11/30/2000 0 OTH OTH 1
0164382 01/03/2001 MI 0.4 0 .5 M 12/15/2000 Parent called at 14:10, to report child had been crying inconsolably since the time of injection. Injection site on right leg red and swollen. Pt was treated with Tylenol-afebrile. Parent called PP. U 12/15/2000 12/15/2000 0 PUB PUB NONE MI2000100 1
0164383 01/03/2001 NJ 45.0 46 F 02/14/2003 Subsequent to receiving three doses of Lymerix, pt complained of possible arthritis in the hands with achiness and slight joint swelling, which began after the second dose of Lymerix. The physician's assessment was osteoarthritis. Treatment included Celebrex, Maxalt and Ultram. The pt reported that Ultram was not working so Darvocet was prescribed. The pt reported no pain relief from Darvocet as her hand continued to ache, she also noted that she needed too many and it caused increased sedation. The physician's assessment was arthritis. Pt was treated with Vioxx. Follow up information indicated that the events were ongoing. The follow up states the vaccine's medical history included severe recurrent anemia, peptic ulcer disease, helicobacter pylori infection, gastrointestinal bleed, heinz body positive hemolytic anemia, unspecified gammaglobulinemia, low-normal G6PD level, breast mass, mitral valve prolapse, hypercholesterolemia, allergic rhinitis, chronic sinusitis, menstrual migraines, and "fuzzy" vision. She had no known allergies. She had a tick bite on the left shoulder and on the right arm, but no history of Lyme disease. Concurrent medications included Advil, Amerge, Naxait, Excedrin, an allergy shot, Flonase, Pepcid, prevacid, Allegra, and an iron supplement. Concurrent herbal supplements included milk thistle and acidophillous. On 3/23/99, the vaccinee received her first injection of LYMErix 0.5cc in the left deltoid. She received her second injection on 4/20/99, also in the left deltoid, and her third injection on 3/23/00 in the right deltoid. In a Statement of Injuries, the vaccinee's attorney alleged that the vaccinee "suffers from joint pain, in particular in her hands, ankles and knees. She also suffers from fatigue and anemia. In addition, she suffers from headaches." The following info was obtained from medical records. The vaccinee presented to the vaccine provider on 1/11/00, eight months following the second injection of LYMErix, with a chiefl complaint of a headache. She reported htat she had a cold the previous week. She self-medicated with "Benadryl sinus." On examination, the physician noted swollen anterior lymph nodes, postnasal drip, and maxillary pressure. The physician made a diagnosis of sinusitis and prescribed Augmentin and Entex LA. The vaccinee returned to the vaccien provider on 6/12/00, with a chief complaint of "possible arthritis in hands and feet" with achiness and slight joint swelling, which began "a few weeks" after the third LYMErix injection. The physician noted "slight swelling of PIP joints." The physician's assessment was osteoarthritis. The physician prescribed Celebrex and ultram. The vaccinee reported that the Ultram was "not working." Darvocet N-100 was prescribed on 7/17/00. On 7/31/00, at a follow up visit, the vaccinee reported no pain relief from Darvocet as her hand continued to ache (she also noted she needed too many and it caused increased sedation). The physician's assessment was arthritis. Vioxx was prescribed. Relevant labs included: total Lyme disease antibodies were positive at 3.35; Lyme disease IgM antibody, rheumatoid factor, and antinuclear disease antibodies were all negative; C-reactive protein and erythrocyte sedimentation rate were normal. Lyme IgG by western blot was unreadable due to dark background. Lyme IgM by western blot was reported as negative because two of the three required bands were not present; however, the sampel was positive for bands 31 and 30. The physician recorded in the medical record that the pt was "OspA gene positive." The vaccinee was referred to a rheumatologist on 9/11/00. At that time, she reported that her symptoms began two to three weeks following receipt of her third injection of LYMErix. She reported "discomfort and some pain in the PIP joints of her fingers and subsequently pain and discomfort in the left knee. She has had some discomfort in her ankles and hips, but it is mostly the knee and PIP joints that have been giving her problem." The rheumatologist noted that her previously elevated Lyme titer "was probably due to the vaccine." On physical examination, "Her upper extremities were completely within normal limits with the exception of hte PIP joints of all her fingers. They seemed to be somewhat thickened and mildly tender. The lower extremities revealed good range of motion of her hips and knees wihtout any swelling. The left knee though does have pain on comporession of the patella and also tnederness over the lateral joint space on compression of that area. There was good range of motion. There did not appear ot be any crepitus. Her ankles and toes were within normal limits. Her lower back and cervical spine moved well." The rhuematologist stated that the pt "appears to be developing what i feel is some osteoarthritis in her hadns and probably some mechanical derangement in the left knee, either consistent with a torn meniscus or possibly chondromalacia of hte patella." MRI of the left knee was performed on 9/19/00. The radiologist's impression was "there is degenerative joint disease with narrowing of the medial and patellofemoral joint spaces. There is thinning of hte articular cartilage of the femur as well as a small focus of increased signal in the lateral facet/intermediate facet consistent with mild chondromalacia patella. There is a partial tear of the psoterior cruciate ligament. There is intrasubstance increased signal in the posterior horn of the medial meniscus consistent with degenerative change." The vaccinee was seen again by the rheumatologist on 9/28/00. At that time, "she continues to ahve a lot of discomfort in that knee." The rheumatologist stated, "There were significant degenerative changes present within the knee and the meniscus as a cause for her complaints." The rheumatologist prescribed Arthrotec 75mg twice daily. On 5/7/01, the vaccinee returned to the vaccine provider with a chief complaint of "headache with dizziness all weekend. pt thinks she's anemic." She also reported that she was under the care of a "Lyme specialist," who had made a diagnosis of chronic Lyme disease and prescribed (Biaxin) and Ceftin. On physical examination, the physician noted pallor. The physician's assessments were "dizziness, headache, pallor." lab analyses revealed decreased hemoglobin and hematocrit and increased "feeling better." Headache and allergy symptoms were "better." She reported one black stool. She reported that she had been taking more Advil. She was still pale. The physician's assessments were "anemia, status-post PUD." The physician prescribed Prevacid and Niferex. The physician referred the vaccinee to a gastroenterologist. The vaccinee was seen by the gastroenterologist on 5/10/01, due to fatigue and black tarry stool. At that time, the vaccinee reproted her general health as "good." She reported that she was being treated for Lyme disease with Biaxin and Ceftin. Rectal examination revealed "dark and stornly hemocuult positive" stool. The gastroenterologist's impressions wee "Macrocytic anemia with prior history of hemolytic anemia. Histroy of peptic ulcer disease now with heme positive stool. History of Lyme disease." The vaccinee was instructed to continued Prevacid therapy and increase the iron dosage. The vaccinee underwent panendoscopy on 5/29/01, which revealed antral gastritis. On 6/7/01, the red blood cell count was decreased and mean corpuscular hemoglobin was elevated. Pharmacy records indicated that the vaccinee was under the care of an "emerging diseases specialist" from at least 11/10/00 until at least 4/16/01. During this period, the specialist prescribed Lortab, Biaxin, Ceftin, Darvocet-N 100, Suprax, and amantadine. The most recent info, received on 5/14/02, did not provide the outcomes of the reported event. Y N 03/23/2000 04/01/2000 9 07/10/2000 CRF = 0.5 MG/DL; MCV 101 FL; ESR 5 MM/HR; RF negative;anti-nuclear antibodies negative; Lyme disease antibodies positive; Lyme disease IGM antibodies negative; Lyme IGM Western Blot negative OTH OTH Allergy shots; Amerge Allergic rhinitis; Breast mass (1996); Chronic sinusitis; gastrointestinal bleed; iron deficiency; menstrual migraines; peptic ulcer disease; recurrent severe anemia. Pt had a tick bite in 1992 and in 1995. 2000036835 1
0164385 01/03/2001 NY 0.5 0 .5 M 11/27/2000 Pt developed a rash . Pt had a fever of 102F. Pt was seen in the ER and was treated with Benadryl. Fever disappeared the same evening. Y Y 11/13/2000 11/13/2000 0 PUB PUB NONE NONE 1
0164386 01/03/2001 NJ 58.0 58 M 12/28/2000 The pt received his 1st 2 injections of Lymerix on 3/15/99 and 4/16/99. He received his 3rd Lymerix and 3/17/00 and approximately 2 months post vax the pt experienced severe tiredness and developed a moderately unbalanced gait with some paresthesia. Pt gradually worsened over time and was referred to a neurologist. The neurologist made a diagnosis of "spastic motor skills". An MRI of the brain and neck was interpreted as normal. The vax provider considered the tiredness, unbalanced gait and paresthsia to be possibly related to Lymerix administration. The neurologist stated that the "spastic motor skills" were possibly related to Lymerix administration. The tiredness, unbalanced gait, paresthesia, and spastic motor skills persisted as of 12/19/2000. Y N 03/27/2000 05/27/2000 61 MRI of brain and neck normal PVT OTH NONE coronary artery disease, hypertension 20000349091 1
0164387 01/03/2001 NJ 42.0 41 M 02/14/2003 Report A0340224A (formerly 2000036741-1) describes arthralgia in a 42 year old male who received Lyme disease vaccine recombinant OspA (LYMErix). This report was received as part of litigation proceedings, in the form of medical records forwarded by an attorney. The medical history included depression, for which the vaccinee was on disability. He had no known allergies. he was a tennis pro for 20 years. He recalled having at least one tick on him. Concurrent medications also included venlafaxine hydrochloride (Effexor XR), levofloxacin (Levaquin), and atorvastatin (Lipitor). Follow the reported onset of arthralgia, the vaccinee experienced pneumonia and hypercholesterolemia. These events were not reported as adverse events due to vaccine administration, but were found during the course of review of the vaccinee's medical records. Therefore, they are not listed as adverse events. Subsequent to receiving the second dose of Lymerix, the pt began to experience arthralgia and myalgia involving the heel, knee and lower back. He sought medical treatment. The physician prescribed Celebrex and physical therapy. The pt was switched from Celebrex to Vioxx. The pt was again seen by the physician at which time he continued to have arthralgia and myalgia affecting the thoracic vertebrae, lower back, both shoulders and the left knee. No joint redness or swelling was noted. The pt admits that the symptoms are getting better with physical therapy. The outcome of the arthralgia and myalgia was not known. The follow up states the vaccinee returne dot the vaccine provider on 8/14/01, and reported that he was under the care of a "Lyme specialist," who had amde a diagnosis of Lyme disease and prescribed Biaxin and Ceftin. He was seen by the vaccine provider on 1/2/01. At that time, he stated that the "Lyme specialist" had made a diagnosis of "reaction to Lyme vaccine." The vacicnee complained of malaise, joint pain, and memory deficits. The vaccine provider's assessment was "Lyme." The vaccinee was evaluated by another physician on unspecified dates. The vaccinee reported "severe" joint pain in the neck and elbow that began within one week of receiving the second injection of LYMErix. The joint pain was reported to worsen the second week post-immunization. The vacicnee reported that he then expeirneced "severe" joint pain in his neck, elbow, right shoulder, left knee, and lower back. He also reported "sugar craving" and pain in both Achilles tendons. He stated that he was under the care of a "Lyme specialist," who had mad a diagnosis of Lyme disease and prescribed Biaxin and Ceftin. The "Lyme specialist" also prescribed Valtrex for the treatment of fatigue. The physician noted that "some of trigger points hurt." The physician reviewed the results of Lyme IgG and IgM western blots performed by the "Lyme specialist" on 6/19/00. The physician's assessments included "Lyme" and "Lyme vaccine." The physician prescirbed Zithromax and Bexra. On 12/17/01, polymerase chain reaction (PCR) analysis for Lyme disease was negative as were IgG and IgM western blots. He returned to this physician on 3/18/02 and reported that he was "feeling good joint wise" but was experiencing night sweats. Serum protein electrophoresis revealed a normal pattern on 4/17/02. On 2/11/02,in a Statement of Injuries, the vaccinee's attorney alleged that the vaccinee "suffers from joint pain and arthralgia in his elbows, shoulders and knees, along with back and muscular pian. He also experience fatigue, memory loss and difficulty concentrating." THe most recent info was received on 6/13/02. As of 3/18/02, the vaccinee was "feeling good joint wise." The outcomes of the other reported events were not provided. The adverse events arthralgia, memory loss, and concentration difficulty do not meet serious criteria but are being submitted as an expedited report by special FDA request per the 6/28/00 letter. Y U 07/14/1999 08/01/1999 18 Testing for rheumatoid arthritis; Lyme titer in 2/00-neg. On 4/14/00, RA latex and antinuclear antibody titer-neg. Western Blot for Lyme IgG was neg. Lyme Titer by EIA-0.95 (Equivocal). On 12/17/01, polymerase chain reaction (PCR) analysis for Lyme disease was negative as were IgG and IgM western blots. OTH OTH Serzone; Effexor Depression A0340224A 1
0164389 01/03/2001 OK 84.0 84 F 11/29/2000 Approximately 5-6 hours post vax, pt started breaking out with hives. Benadryl 50mg given every 4 hours with no improvement by 11/26/2000. Pt went to ER, medication given 11/28/2000, not much improvement. Pt returned to physician. Y Y 11/24/2000 11/24/2000 0 NONE PUB PUB NONE NONE allergic to penicillin, codeine, ASA OK0049 1
0164390 01/03/2001 OK 39.0 39 F 12/14/2000 Pt developed 3cm X 2cm area of redness and heat with slight swelling in right deltoid. Y Y 12/12/2000 12/14/2000 2 NONE PUB PUB NONE NONE allergic to mold OK0051 1
0164391 01/03/2001 MA 28.0 28 F 12/26/2000 Pt experienced left arm pain lasting 8 days at the injection site. Y 12/17/2000 12/18/2000 1 OTH PVT NONE ASA allergy; psoriasis 1
0164392 01/03/2001 WI 48.0 48 F 12/07/2000 The pt experienced a rash on the abdomen, spots on left and right thigh above the knee, numbness. Treated with over the counter Benadryl. U 12/04/2000 12/04/2000 0 PVT PVT Demulen; Benzomycin; Flonase Acne; chronic sinusitis; positive TB skin reaction; allergic to cats, cantaloupe and dyes 1
0164393 01/03/2001 VA 44.0 44 F 12/19/2000 Pt developed redness, mild fever and pain on left breast. Pt was seen by MD who diagnosed mastitis and treated with Cipro. Redness resolved in one week, pain resolved in two weeks. MD would not rule out or rule on caused by flu shot. Y Y 12/08/2000 12/09/2000 1 NONE; mammogram ordered for January PUB PVT Flexil NONE Pt allergic to sulfa, cepharadine, Ceftin, Bioxin, Ultram Hydrocodone APAP, Oxycodone APAC; amoxicillin 1
0164394 01/03/2001 MD 26.0 26 F 12/04/2000 Fifteen minutes post vax, pt took aspirin and five minutes later began to see spots. Pt had nausea, dizziness and difficulty breathing. Pt fainted - one minute. Later felt nauseated. Pt states she had a similar episode a year ago, but it was an anxiety attack. Pt did not seek medical help or evaluation despite recommendation. Y 11/28/2000 11/28/2000 0 NONE PUB PUB NONE NONE 1
0164395 01/03/2001 MD 75 F 12/08/2000 Pt experienced deep cough, thick mucous, unknown fever, no chills, no aches. Dry cough 4 days ago - progression, swollen neck, glands, sore throat earlier. Duration 4 days. U 11/21/2000 12/04/2000 13 NONE PUB PUB Tylenol NONE 1
0164396 01/03/2001 PA 64.0 M 12/24/2000 Pt developed severe hives which began approximately 5-6 hours post vax lasting 4 days. Pt was treated with Benadryl and ultimately Zyrtec. Y MIL UNK aspirin, Plavix, ????? recent angioplasty ????11/28/2000 1
0164397 01/03/2001 KS 35.0 35 F 12/26/2000 Pt experienced a sore, scratchy throat, swelling and painful; watery eyes, swelling and red; and shortness of breath. No local reaction noted. Pt was treated with Zyrtec PO X 3 doses. Y 12/07/2000 12/07/2000 0 NONE PUB PVT NONE NONE 1
0164398 01/03/2001 NY 30.0 30 F 12/04/2000 One day post vax pt experienced tenderness in right armpit that resolved within one day. Six days post vax the tenderness returned, the next day right arm very tender, numbness in right arm, thumb and finger tips. Y 11/13/2000 11/14/2000 1 PUB UNK NONE NONE NONE 1
0164399 01/03/2001 CA 52.0 52 F 12/28/2000 Approximately 10 minutes post vax pt became sweaty and red around neck; heart pounding, and felt like she was going to pass out. Pt experienced shaking, trembling, facial numbness and tingling in ankles. Y Y 12/14/2000 12/14/2000 0 EKG OTH OTH ibuprofen, estraderm NONE PCN, erythromycin, shellfish 1
0164400 01/03/2001 FL 41.0 41 F 12/20/2000 Pt experienced swollen ears and hives. Y Y 12/19/2000 12/19/2000 0 Recommended skin tested. MIL UNK NONE NONE environmental allergies 1
0164401 01/03/2001 IL 66.0 66 F 12/28/2000 four days post vax pt awakened with great degree of stiffness and pain in arm muscles above and below the elbow and muscles in buttocks. Pt still experiencing same problems at the time of report. Y Y 10/25/2000 10/29/2000 4 OTH OTH NONE sulfa 1
0164402 01/03/2001 CA 64.0 64 M 12/27/2000 Pt experienced three slight dizzy spells about 1.5 hours post vax. Each spell lasted about 20 seconds approximately 30 minutes apart. Y 12/09/2000 12/09/2000 0 PVT OTH Theophyllin, Ventolin, Ranitidine NONE Asthma 1
0164403 01/03/2001 VI 36.0 36 F 12/20/2000 Pt complained of runny nose, itching and rashes, presented to ER with erythema rashes on the chest, lung clear, no swelling of tongue or neck. Pt treated with Benadryl, Solumedrol, Epinephrine and Tylenol. Y Y 12/14/2000 12/14/2000 0 NONE PUB PVT Dilantin, Neosporin MS, Contin NONE Intractable headaches, seizures 1
0164404 01/03/2001 GA 39.0 39 F 12/27/2000 Approximately 1 hour post vax, pt experienced dizziness, numbness spreading from thighs to upper arms, feeling as though she was going to pass out, nausea, loose bowels and shakiness. All symptoms came in waves, waxing and waning for approximately 7 hours. Y Y 11/16/2000 11/16/2000 0 NONE PVT PVT Serevent; Flovent; Singulair; Ventolin; Zithromax Mild bronchitis chronic asthma-like lung disease 1
0164405 01/03/2001 NY 32.0 32 F 12/26/2000 Within a few minutes post vax her arm became swollen, red and hot to touch and very sore. Y 11/13/2000 11/13/2000 0 NONE PUB OTH Atentol; Paxil NONE elevated blood pressure 1
0164406 01/03/2001 NM 47.0 47 F 12/22/2000 Pts arm was sore and 24 hours later pt experienced fatigue and malaise. Two days post vax RU quadrant pain. the next day pt was seen in ER. Liver enlarged upon physical. Pt treated with Vicodan Y U 12/15/2000 12/17/2000 2 PUB UNK E Barr, Porphyria, Asthma AZ0035 1
0164407 01/03/2001 NY 61.0 61 F 12/27/2000 Three days post vax pt experienced itching of right wrist, and pinkness of legs, arms and scalp. By the next afternoon pt developed large welts all over and ears were red. Pt went to urgent care and was told it was an allergic reaction to something, possibly flu vax. Pt treated with Benadryl. Y Y 12/01/2000 12/04/2000 3 PUB PUB diabetes, asthma 1
0164408 01/03/2001 KY 72.0 72 F 12/22/2000 Two days post vax, pt returned to clinic. Complained of left arm hurting, arm red starting at mid upper arm down to below the elbow. Evident swelling right above and below the elbow. Referred to private physician. Y U 12/20/2000 12/20/2000 0 PUB PUB KY2000046 1
0164409 01/03/2001 TX 62.0 62 M 12/28/2000 Pt reported running a high fever and rash after receiving vax. Also complained of aching and joint pain. Recovering, fever resolved but achiness remains. Pt still has a rash on arm. 12/26/2000 12/26/2000 0 PUB PUB Glyburide, Aetos NONE diabetes 1
0164410 01/03/2001 MA 25.0 25 F 11/07/2000 Pt complained of soreness in left arm with pain at injection site radiating to clavical and scapular areas. Pt saw nurse at Occupational Health Center at Brigham Women's and was told it was due to the flu shot and it should subside in 2 days or so. Pt fully recovered. Y 11/06/2000 11/06/2000 0 MIL UNK BCP NONE 1
0164411 01/03/2001 IN 52.0 52 F 12/06/2000 Pt experienced hives on face, arms and knees. Y 11/30/2000 12/01/2000 1 NONE PUB OTH Ridaura, Thyroid, Procardia NONE Rheuarthritis, Raynauds; allergy to OSA and Celebrex IN200044 1
0164412 01/03/2001 IN 48.0 48 F 12/06/2000 Pt experienced swelling, redness and itching on left side of face and left arm. Y 12/04/2000 12/04/2000 0 NONE PUB OTH diabetes, hypertension, hyperlipidemia IN200043 1
0164413 01/03/2001 IN 57.0 57 F 12/27/2000 Pt experienced swelling, redness and streaks going under arm pit from injection site. Injection site was like a boil. Pts entire right shoulder was hot, swollen, and reddened. Body temperature was 101F for approximately two days. Pt also had feelings of fatigue and a cough. Follow up on 01/30/2001: "None of this information was given to me. Was told at open that visiting service should have given me this information." Y Y 12/14/2000 12/15/2000 1 NONE UNK PVT Zestril, Prempro, Allegra, Hetz hypertension, allergic to dust, mold and ragweed. 1
0164414 01/03/2001 OH 0.2 0 .2 F 12/26/2000 Post vax, had 4 days of inconsolable crying, decreased intake, minimal sleep and unresponsive to acetaminophen. No fever and normal physical exam on 12/22/00; leg not swollen or tender. Y Y 12/19/2000 12/19/2000 0 Blood cultures-nml; urine culture-nml; UA-nml PVT PUB NONE NONE NONE 1
0164415 01/03/2001 OK 0.6 0 .6 F 10/09/2000 Redness and pain at injection site X 7 days and also crying for extended periods of time X 7 days. Y 10/02/2000 10/03/2000 1 NONE PUB PUB NONE NONE NONE OK0050 1
0164416 01/03/2001 MI 12.0 12 F 12/11/2000 "I could feel the stuff (vaccine) go up my arm as far as my neck then it went away". No visible bump at site at this time. On 12/7/00, I noticed a rash on my back near shoulder blade. Developed abdomen rash on 12/10/00 was on chest previously. Denies pain at this time but had major itching. "She had hives on her abdomen on 12/10/00 but was not visible 12/11/00. Also a fine rash on abdomen. Y U 12/05/2000 12/07/2000 2 NONE PUB UNK NONE NONE "I can't wear earrings that aren't gold" and I have a "stuffy nose in AM". MI2000099 1
0164417 01/03/2001 MI 35.0 35 F 12/11/2000 Within 15 minutes, post vax, client was driving back to work and experienced shortness of breath, dizziness, weakness and shaking of hands and feet. Client pulled into a gas station and had attendant call 911 and was taken to the hospital. She also experienced shortness of breath and dizziness on 12/09/00 and went to ER and was treated with IV fluids. She was released the same day but didn't state a dx from hospital or plan for further shots. Y Y 12/08/2000 12/08/2000 0 EKG PUB PUB Flonase, nasal inhaler; TB/Connaught/C015AA/ID/LA NONE Allergies sulfa; nasal allergies MI2000101 1
0164418 01/03/2001 GA 5.0 1 .0 M 12/27/2000 Dx: Modified chickenpox with 10-20 lesions. Y Y 11/26/1996 12/26/2000 1491 PVT PVT 1
0164419 01/03/2001 NC 4.0 4 F 12/21/2000 Swelling, erythema and heat in right thigh. Y U 12/19/2000 12/20/2000 1 NONE PVT PUB NONE 1
0164420 01/03/2001 CA 1.25 1 .3 F 12/15/2000 Mom states toddler had fever, 7 days post vax. Cried and lacked appetite for 5-6 days duration. Mom noticed swelling on left side of neck below ear on 12/11/00 and appetite improved, alert, active and happy. On 12/28/00, swelling still persists and is hard to the touch. Y 11/28/2000 12/05/2000 7 NONE PUB PUB NONE NONE CA000149 1
0164421 01/03/2001 OR 0.3 0 .3 F 12/19/2000 Mother noticed increased fussiness of her baby on 12/16/00 and felt a lump present on 12/19/00. Lump assessed by PHN at health dept. Lump of left thigh to about 2 1/2cm X 3cm in diameter with slight localized redness at site of lump. Mom denies that infant had not even developed a fever with this lump. Recommended warm wet packs to site and return if not resolved or call PMD. U 12/15/2000 12/16/2000 1 PUB PUB NONE NONE NONE OR200041 1
0164422 01/03/2001 OR 66.0 66 F 10/31/2000 Edema in left arm, 2 weeks later. Edema in right arm, 3 weeks later. Ultrasound demonstrates non-occlusive clot left axilla, subclavian brachial vein. Y N 10/04/2000 10/13/2000 9 Ultrasound yielded non-occlusive clot PUB UNK UNK NONE Vertigo; history of rheumatoid arthritis, Raynaud's Syndrome OR200042 1
0164423 01/03/2001 OH 1.0 1 .0 F Awoke on 12/7/00 with fever of 102.5F. Did not respond to Tylenol. Temperature continued to increased up to 104.3F with OTC thermometer. Took her to the ER and they could not find anything wrong and was told it was a "virus" and was placed on antibiotics. Had a generalized red, raised rash and was lethargic. By 22:30, feeling better. Temperature 102.4F which responded to Motrin on 12/8/00. No longer had elevated temperature. "Back to normal" but still had rash. Y Y 11/27/2000 12/07/2000 10 Throat culture-neg for strept. PUB PUB NONE NONE NONE OH0058 1
0164424 01/03/2001 FL 3.0 3 M 12/29/2000 Erythematous area at injection site (LDT) extending from shoulder to elbow and measures 6" in length and 5" across arm. Right upper arm measures 7" around and left upper arm measures 9" around. Temperature is 98.7F; no pain or loss of motion in arm. No systemic symptoms. U 12/27/2000 12/28/2000 1 PUB PUB NONE NONE NONE 1
0164425 01/03/2001 WA 8.0 8 M 12/26/2000 Wheezing within 24 hours of 1st 2 Hep-B shots. Y 12/21/2000 12/22/2000 1 PVT UNK Attention Deficit Disorder Wheezing~Hep B (no brand name)~1~8.00~In Patient 1
0164426 01/03/2001 FL 1.0 1 .0 F 12/29/2000 Erythema and swelling on right thigh area. Y 12/26/2000 12/28/2000 2 NONE PVT PVT NONE NONE NONE 1
0164427 01/03/2001 MO 11.0 11 M 12/29/2000 On 12/28/00, at about 7 or 8 PM, pt complained of a headache. Awoke early AM on 12/29/00 and "felt weird"; got up and took a shower. Then around 8 AM, had a fever of 104F (ear); 103.6F (ear); pulse 104. Had a runny nose "all week". U 12/28/2000 12/28/2000 0 PUB OTH NONE Runny nose, sore throat and cough; had all week. NONE 1
0164428 01/03/2001 MI 13.0 12 F 12/18/2000 Pallor complexion, nauseous, light-headed, blurry vision and crying. Stopped before leaving office. Y 12/18/2000 12/18/2000 0 PVT UNK NONE NONE 1
0164429 01/03/2001 MA 39.0 39 F 12/28/2000 24 hours, post vax, pt experienced chills, fever and body aches. She was given Rocephin 500mg IM to be followed by Ceclor 500mg po tid. Y 11/29/2000 11/30/2000 1 On 12/01/2000; WBC-21.3; Chest X-ray-neg PVT PUB Paxil 20mg qd NONE NONE 1
0164430 01/03/2001 VT 1.25 1 .3 F 12/26/2000 Post vax, pt was fussy in the evening and moaning after she went to sleep. Mom noted legs/arms shaking, flailing but stopped with mom's touch. One arm very cool to touch for "awhile". When child was awakened, seemed a little dazed. Next AM, was cranky but playful. Normal exam in office. Several days later developed enteritis (suspect community acquired as very prevalent now and sibling with symptoms). Y 12/18/2000 12/19/2000 1 NONE PVT PUB Fluoride, Acetaminophen NONE NONE 1
0164431 01/03/2001 IN 1.25 1 .3 F 11/08/2000 Pt had fever up to 103F which began on 10/30/00 and responded to Tylenol but went back up between doses. She had a poor appetite, was irritable, had a rash on her back and stomach. Saw doctor on 11/4/00 and was given antibiotics for possible ear infection. Fever for 4 days. Y Y 10/25/2000 10/31/2000 6 PUB PUB NONE IN200042 1
0164432 01/03/2001 NH 14.0 14 M 12/06/2000 On 12/6/00, pt developed a fever of 103F and his left arm was swollen and solid. He had chills as well. Pt was given 2 Advil every 4 hours and had ice placed on his left arm. Pt was also encouraged to drink plenty of fluids. Y 12/05/2000 12/06/2000 1 PUB PUB NONE NONE NONE NH0023 1
0164433 01/03/2001 NH 2.0 2 .5 F 11/02/2000 Noticed rash on legs on 11/3/00. Presented here with primarily scabbed lesions, some vesicles and papules over all of body including diaper area. Temperature 99.3F, runny nose and rash is pruritic. Y N 10/26/2000 11/01/2000 6 NONE PVT PUB NONE Past history of seizure activity-poor medical history NH0021 1
0164434 01/03/2001 MO 0.6 0 .6 M 12/28/2000 7cm X 4cm firm induration to shot site on left thigh. Y Y 12/19/2000 12/21/2000 2 PVT UNK NONE 1
0164435 01/03/2001 NY 12.0 12 M 11/10/2000 Swelling and erythema of left upper half of the arm noted on 11/10/00. Child had vaccine on 11/8/00, only had slight erythema at the site of injection secondary to pain in arm. Is still under care. U 11/08/2000 11/08/2000 0 OTH OTH NONE NONE Mosquito bite 1
0164442 01/04/2001 CA 0.25 0 .2 F 12/21/2000 This pt expired probably due to SIDS per pt's doctor. No record in pt's chart but pt's doctor said that the death was reported in the newspaper and that the baby was found lying face down in crib. No record at county coroner's office. Y 08/12/1999 N 04/27/1999 08/12/1999 107 OTH PVT 1
0164451 01/04/2001 NY 57.0 57 F 11/07/2002 A nurse reported that her 56 year old aunt received an injection of Flu-Shield (2000-2001 Formula) in 12/00. Two days, post vax, she collapsed and developed nausea, vomiting and dizziness. She was seen in the ER where they reportedly could find nothing wrong and was sent home. Afterwards, she was weak and did not feel well. On 12/25/00, she awoke with right-sided facial paralysis and "dropping", was disoriented and did not feel well. She was taken to ER where they reportedly could find nothing wrong and was again sent home. On the way home, she seized in the car and was taken to the hospital where she was admitted into the ICU. The swelling of the brain from the tests, was undeterminable. She was unresponsive until 12/28/00; however, the reporter noted that the pt was very sedated. She developed a fever and was opening her eye briefly and was able to move her legs as of the date of this report. Y Y Y U 11/18/2000 brain scan - swelling of both sides of the brain, MRI - swelling of both sides of brain, no tumors or infection OTH OTH Baycol, Sudafed UNK UNK HQ5383229DEC2000 1
0164452 01/04/2001 LA 0.3 0 .3 M 12/27/2000 The pt developed an acute onset of fever and seizures. Self-limited, lasting less than 1 hour (seizures). Low grade fever for 48 hours. Y Y 1 Y 12/18/2000 12/18/2000 0 MIL MIL Amoxicillin NONE 1
0164453 01/04/2001 FL 0.3 0 .2 F 12/01/2000 The patient has high pitch crying for 4 hours after his shots. Persistence of crying for 20 hours. 09/26/2000 09/28/2000 2 NONE PVT PVT NONE NONE NONE 1
0164454 01/04/2001 CA 2.0 2 .9 M 12/05/2000 The patient is red, warm, swelling, itching, and has a 12 by 12cm area to the left deltoid. Y Y 11/30/2000 12/01/2000 1 PUB PUB History of seizure disorder, obesity. CA000152 1
0164455 01/04/2001 CA 1.0 1 .0 F 12/15/2000 The infant developed a runny nose and cough a few hours after the vaccination. The patient also became irritable, developed a fever around midnight. Adverse event resolved by 12/13/00. Prescription: Tylenol. Y Y 12/11/2000 12/11/2000 0 NONE PVT PUB NONE NONE NONE CA000147 1
0164456 01/04/2001 CA 0.75 0 .8 F 12/23/2000 The patient was given Hepatitis B and Prevnar immunizations on 12/19/2000. The next day the patient had swelling to the face, fussiness, and a low grade temperature. The patient had swelling, tenderness, a local reaction at the Prevnar immunization site. Y Y 12/19/2000 12/20/2000 1 NONE PVT PVT NONE NONE NONE 1
0164457 01/04/2001 SD 15.0 14 M 11/28/2000 The patient got a vaccination, a golf ball size, red, raised welt appeared. By 8PM hives, large, red welts with the largest welts on the thighs. Joints and hands became swollen (unable to hold pen on Wednesday). The physician evaluated the patient on Wednesday 11/08/00, prescribed Prednisone, Hydrocortisone cream, soda baths. Hives lasted approximately 9 days. Last hives present on bilateral feet. Y Y 11/04/2000 11/04/2000 0 PUB UNK NONE NONE Bactrim 1
0164458 01/04/2001 KS 52.0 52 F 12/26/2000 The patient has achy muscles, burning eyes, headache, and chills. Treatment: Nyquil Employee has multiple allergies: Food testing planned for 1/01. Y 12/14/2000 12/14/2000 0 NONE PUB PVT Zocor, Zertec NONE Environmental allergies 1
0164459 01/04/2001 FL 73.0 73 F 12/28/2000 The pt experienced right sided facial droop, diagnosed with bells palsy. Y U 12/27/2000 12/28/2000 1 MRI - nml PVT PVT Prevacid, Valium, Levoxyl, Zocor, ASA hypothyroidism, hypercholesterolemia, GERD, depression 1
0164460 01/04/2001 ME 52.0 52 F 01/02/2001 The patient had weakness in lower limbs, loss of feeling of balance. The patient has to use a cane to maintain balance. This is new. N 11/30/2000 12/03/2000 3 Last Flu shot 1976, after had thyroid removed. PVT PVT Synthyroid, Inderal NONE Muscular Dystrophy 1980, irregular heart beat. 1
0164461 01/04/2001 NH 47.0 47 F 01/02/2001 The pt complained of vertigo and was unable to drive home. The pt also experienced nausea, vomiting. Vertigo is about 95% improved as of today. Y 12/12/2000 12/12/2000 0 NONE OTH OTH Premarin NONE 1
0164462 01/04/2001 TN 51.0 53 F 12/05/2000 1 hour post vax, the pt had severe pain in left arm, and thought she would pass out. The pt also experienced pain at the injection site traveling to the muscles over shoulder blade and down to the wrist, later that night to her hear muscles. The pt experienced a decrease in strength and a decrease in forward range of motion. U 10/23/2000 10/23/2000 0 NONE PUB PVT NONE can't tolerate beta blockers TN00049 1
0164463 01/04/2001 CA 54.0 54 F 12/21/2000 Muscles: Burning and stiffness, legs, arms, overall ache, especially at night. Joint: Stiff/arthritic feeling and difficulty walking. Breathing: Labored; general fatigue and pain over chest area and under arms/mentally disoriented. I went to Urgent Care on 12/13/00 and the doctor prescribed Ativan so that I could sleep (the pain is overwhelming just turning over) and was told to maximize my nutrition and reduce my stress levels. I have transferred to a different clinic but cannot be seen until 1/4/01 because of HMO regulations. Mentally, I become confused easily, especially with numbers and dates and I have noticed that I wobble when I walk. Up to now, my health and mental attitude have been very good. Y N 11/24/2000 11/27/2000 3 Blood tests-all nml PVT PUB Tenormin NONE History melanoma (skin); HTN, UTI 1
0164464 01/04/2001 AZ 4.0 4 F 12/26/2000 Erythema, edema right shoulder and upper arm (2/3); increased warmth, non-tender; 1 blister X 2 where bandaid was; non-blanching; + induration over deltoid area of right arm. Y 12/13/2000 12/13/2000 0 NONE PVT PUB NONE NONE Aortic stenosis 1
0164465 01/04/2001 IL 1.0 1 .0 F 12/28/2000 Febrile convulsion on 12/27/00; seen in ER at 00:47. Return if fever persists or any other concerns or if has another seizure. Should see a doctor within 2 days. Y Y 12/26/2000 12/27/2000 1 PUB PUB Tylenol drops NONE NONE 1
0164466 01/04/2001 VA 7.6 2 .2 M 12/29/2000 5-7 erythematous, raised lesions on trunk and neck X 24 hours. Complaining of itching. Afebrile. Y U 08/30/1995 12/28/2000 1947 PVT PVT NONE NONE NONE 1
0164467 01/04/2001 CA 1.2 1 .1 M 12/14/2000 On 12/1/00; well child check; OM noted and began Amoxil, no fever, so MMR II and Varivax given. On 12/8/00; rash noted. On 12/9/00; had fever and was fussy per mom's report. On 12/10/00, seen for rash, still with OM so Keflex began but rash was down from 12/8/00 and no fever. On 12/11/00; rash more erythematous with increased induration over arms. Antibiotics changed to Zyrtec (Keflex discontinued). No fever. Still with rash, Follow-up on 12/21/00, to assess. Y U 12/01/2000 12/08/2000 7 NONE PVT PUB Benadryl, Amoxil, Keflex, Zyrtec OM NONE CA000151 1
0164468 01/04/2001 CA 52.0 52 F 12/15/2000 Pt feels tired, no energy. Back and muscles ache. States she feels "fragile". Sinus congestion. U 11/28/2000 12/02/2000 4 NONE PUB PUB Estrogen, progesterone, thyroid medication NONE NONE Unspecified reaction~Meningococcal (no brand name)~1~44.00~In Patient CA000150 1
0164469 01/04/2001 CA 0.2 0 .2 M 12/18/2000 Approx. 6 hours, post vax, child had a hypotonic-hyporesponsive episode. Y Y 09/29/2000 09/29/2000 0 NONE PUB PUB NONE NONE NONE CA000148 1
0164470 01/04/2001 CA 18.0 18 F 12/12/2000 Pain in area of injection site, numbness to left forearm, pain and numbness to left buttocks. Appears to be minor. U 12/11/2000 12/11/2000 0 NONE PVT PUB NONE NONE NONE CA000153 1
0164471 01/05/2001 DC 43 F 12/06/2000 The pt experienced localized erythema at the site of injection 24 hours post vax. The pt also experienced pain at the injection site,, swelling of tissue with palpable nodule. U 12/04/2000 12/05/2000 1 NONE PUB PUB NONE NONE 1
0164472 01/05/2001 IA 38.0 38 F 12/27/2000 The patient had pain to her left upper arm and shoulder since approximately 2 hrs post administration. The patient was seen by DR on 12/27/00 and was placed on EC Naprosyn. The patient was diagnosed with arm soreness. Y U 12/13/2000 12/13/2000 0 NONE OTH PVT Tetracycline NONE Keflex, and Voltaren allergies. 1
0164473 01/05/2001 IA 39.0 39 F 12/27/2000 The pt experienced pain at the shoulder, arm and neck on the same side of injection. The pt went to the MD 9 days post vax and was then diagnosed with muscular pain. The pt was treated for pain and heat. Y U 12/13/2000 12/18/2000 5 NONE OTH PVT Celexa, Klonopin NONE seasonal allergies 1
0164474 01/05/2001 IA 53.0 53 F 12/28/2000 The patient has left arm discomfort. U 12/13/2000 12/13/2000 0 OTH UNK 1
0164475 01/05/2001 OR 1.6 1 .4 F 12/29/2000 The patient had local erythema and edema (5x6cm). She was treated with Benadryl and Motrin. Y Y 10/21/2000 12/12/2000 52 NONE PVT PVT NONE NONE NONE 1
0164476 01/05/2001 OH 1.3 1 .4 F 01/02/2001 On 1/2/01, mom reports small 2" diameter of blister-like rash around injection area on both thighs. Just noticed this AM. U 12/26/2000 01/02/2001 7 PUB PUB Mild upper respiratory congestion Down's Syndrome, post AVSD repair Sick/vomiting~Varicella (Varivax)~1~1.00~In Patient 1
0164477 01/05/2001 OH 39.0 39 F 12/29/2000 Received TD and Pneumococcal on 12/28/00 at 15:00 and by evening had pain in left arm, shoulder, soreness in left arm pit, nausea, fever and headache. On 12/29/00, arm still with soreness, sore to touch and move (not as bad as yesterday). Still with headache. U 12/28/2000 12/28/2000 0 NONE PUB PUB NONE NONE Allergy to Ampicillin, self-reported respiratory problems 1
0164478 01/08/2001 IN F 01/03/2001 A nurse reported that a pt received an injection of 2000-2001 formula influenza virus vaccine in 2000 and subsequently, developed Guillain-Barre syndrome. This report of a serious, labeled event is being submitted in a 15-day time frame, as requested by FDA. See cancelled report, HQ4993318DEC2000. Follow-up received on 1/2/01, indicated that the pt was an elderly female who received 1999-2000 formula influenza virus vaccine. Five to 6 months, post vax, she developed Guillain-Barre syndrome. She died. Y N UNK OTH OTH UNK UNK UNK HQ5472103JAN2001 1
0164479 01/08/2001 CA 2.0 2 .3 M The pt experienced the following disorders after being vaccinated, autistic entercolitis, speech delay, mentally retarded, auditory processing disorder, auto immune disease, neurological damage, constipation, diarrhea, seizures, hypothyroidism, learning disability, high measles titers, and autism. Y N 08/08/1994 08/08/1994 0 NFP antibody test, auditory processing, MMR titer test - elevated, CDSA test, IQ test, psychological testing PVT UNK NONE NONE ~Measles + Mumps + Rubella (MMR II)~~0.00~In Sibling 1
0164484 01/08/2001 MI 43.0 43 F 01/03/2001 The pt received an injection of Engerix-B on 11/6/00 and 2 days later, her ankles became sore; she described this as "socks felt tight". She did not notice swelling of her ankles. She then experienced a burning sensation of her legs, "like pepper spray". At night, both her arms would fall asleep. Two weeks, post vax, she stopped taking the oral contraceptive to rule out the possibility that "the pill was causing" these events. Her symptoms persisted. She was seen by her physician, who reportedly performed a diagnostic evaluation for diabetes mellitus, which was reportedly negative. The physician confirmed only the burning sensation in the legs, which was reported to occur in the calves, hamstrings and hips. On 1/2/01, the physician reported this event as bilateral leg pain, which began less than 24 hours, post vax, on 11/7/00. The physician did not confirm that a diagnostic evaluation for diabetes mellitus was performed. The pt was treated with prednisone at an initial dose of 60mg daily; the dose was tapered over 10 days and the prednisone was then discontinued. The pt was also treated with Benadryl, as needed. The physician considered the leg pain/burning sensation to be possibly related to Engerix-B and to be disabling/incapacitating. The primary Engerix-B IZ series was stopped. The pt reported that all of her symptoms persisted as of 12/1/00. The most recent information, received from the physician on 1/2/01, indicated that the leg pain/burning sensation persisted. As a result of follow-up information received on 1/2/01, this report has been reclassified as serious, unexpected. Y Y N 11/06/2000 11/07/2000 1 PUB PVT antihistamines, Prilosec, Loestrin Allergic rhinitis, allergic to dairy products, GERD 20000349301 1
0164485 01/08/2001 VA 36.0 F 01/04/2001 The pt received her 1st injection of Engerix-B on 11/30/92 and her 2nd injection on 2/28/93. She did not received the 3rd dose; no explanation provided. In April 1998, she was reportedly dx'd with multiple sclerosis. The pt reported that she currently has paralysis of her left arm, hand and leg. She is being treated with Copaxone 20mg SC daily, Ritalin 20 mg twice daily, Wellbutrin 150 mg twice daily, Prozac 20mg every other day, Tegretol 800mg daily and Tegretol-XR 200mg daily at bedtime. The pt stated that her current physician considers the multiple sclerosis to be possibly related to Engerix-B administration. The paralysis and multiple sclerosis persisted as of 12/28/00. The report is "Medically Serious". Y N 02/28/1993 PVT OTH Demoral Allergy to Demerol 20000369261 1
0164489 01/08/2001 IN 1.5 M 01/02/2001 Information has been received from a woman concerning her 18 month old son who was vaccinated with MMR II at 15 months of age. At the time of his 18 month checkup, the pt experienced loss of language. Additional regression followed. He developed severe bowel problems. At the time of the report, he had a form of colitis which had yet to be determined. He also experienced severe pain, bloody stools and or diarrhea, every day, and almost no language. The loss of language was considered a "Significant Medical Event". No further information is available. Per follow-up report, the lot number of 629553/1784H was added to the lot number field. No further information is available. Follow up on 04/06/2001: "Patient date of birth, adverse event onset date/time, vaccine administration date/time is not provided." U OTH OTH UNK UNK WAES00121512 1
0164490 01/08/2001 CA 1.3 1 .4 M 12/29/2000 The patient has a swollen face, bumps all over the body, Temperature of 99., and angioneurotic edema of hands and feet. This started in less than 24 hours and lasted 4 days with continuous improvement. Prescribed: Decadron, and Benadryl. Y Y 12/27/2000 12/28/2000 1 NONE PVT PVT Finished Zithromax 12/18/2000. Two weeks post bronchitis NONE 1
0164491 01/08/2001 AZ 34.0 34 M 06/22/2000 The patients entire post right forearm red, warm, and swollen; status post Anthrax vaccine 3 days prior. Y 06/18/2000 06/21/2000 3 MIL MIL NONE NONE NONE 1
0164492 01/08/2001 WA 25.0 25 M 06/02/2000 The patient had mild local erythema, followed by onset of probable local cellulitis after 5-7 days. Treated with Keflex. Y Y 05/23/2000 05/26/2000 3 MIL MIL NONE 1
0164493 01/08/2001 DE 48.0 47 F 01/02/2001 The patient has had a sore left elbow for 2 months. Y 06/08/2000 06/09/2000 1 PVT PVT NONE NONE 1
0164494 01/08/2001 NH 1.25 1 .2 F 12/22/2000 The patient developed a fever six hour The patient developed a fever six hours after Prevnar. Then the patient was diagnosed with pneumonia 2 days later. The patient improved with Amoxicillin. Unclear if chance or related. Y Y 12/13/2000 12/13/2000 0 Chest x-ray with pneumonia, WBC=16K PVT UNK Had a cold Possible food allergies, atopic dermatitis 1
0164495 01/08/2001 MS 76.0 76 F 12/21/2000 The patient received the Influenza vaccine on 12/12/00. The patient stated it was very painful when given. The patient returned on 12/20/00 and stated his arm had been painful and achy since injection was given. No edema or erythema was noted a the site, the patient stated it hurts badly to move her arm. Upon inspection the arm appeared normal, but the patient stated she had trouble using the arm but could do ROM, no numbness noted. N 12/12/2000 12/12/2000 0 NONE PUB PUB Arthritis Arthritis MS00055 1
0164496 01/08/2001 NJ 52.0 52 M 11/22/2000 The patient has pain in her left arm which developed about one week following the Flu shot. The patient did not receive vaccine last year, but previously vaccinated. U 11/03/2000 NONE PUB PUB Thyroid replacement, Provacal NONE NONE NJ200025 1
0164497 01/08/2001 NY 58.0 58 F 11/29/2000 The patient has epigastric pain, nausea, shakiness, chills, and weakness for about 6 hours (started 18 hours approximately after injection). The patient had some lower abdominal cramping, and slight diarrhea the second day after her shot. Y 10/30/2000 10/31/2000 1 NONE OTH UNK Singular, Zyrtec, Vitamins, Minerals, and Herbs NONE 1
0164498 01/08/2001 MI 0.2 0 .2 M 12/11/2000 1/2" X 1/4" purple/brownish discolored nodule at left deltoid, slightly mobile. Brought to provider attention on 12/11/00. Mother notes it's smaller than it was. No treatment outside of massage of area. Occurred a few days, post vax. Vaccine was HIB #1. Y 11/17/2000 11/19/2000 2 NONE PVT PUB NONE NONE NONE 1
0164499 01/08/2001 NY 17.0 17 F 12/28/2000 Felt nauseated, sleepy and light-headed after 1/2 an hour, post vax. No wheezing, sore throat or hives. Y 12/28/2000 12/28/2000 0 NONE PVT PVT NONE NONE NONE 1
0164501 01/09/2001 CA 1.3 1 .3 M 12/15/2000 Immediately following vaccination, the pt slept and when he woke up he had a fever and was given Tylenol. We had a hard time keeping the fever down. He was very irritable (crying) his right leg where the vax was given was very red, swollen and he couldn't walk on it. 60 day follow-up states the pt also experienced a decreased blood flow in the brain, experienced regression in speech, language, congnition development, has a sensitivity to foods with casein gluten, corn and soy and a weekened immune system. Y N 01/13/1998 01/13/1998 0 PVT PVT Tylenol/children's Flu NONE 1
0164502 01/09/2001 GA 1.25 1 .3 M The pt started to have a seizure due to the pertussis vaccine. Y N 01/08/1998 01/08/1998 0 PUB PUB Asthma 1
0164503 01/09/2001 MN 37.0 37 F 11/21/2000 Serum sickness syndrome; rash with pruritus and some swelling in hands. We identified this reaction through retro-spectrum chart review as part of the hospital's program. It may have already been reported to you. Also diagnosed with tinea pedis, Neutropenia, lymphocytopenia, Eosinophilia, anemia Y 4 Y 05/17/2000 05/19/2000 2 PUB UNK Ultram, Centrum ASA allergy, a vascular neurosis of femoral head, allergic rhinitis, malaria-treated in 1984. MN00006 1
0164504 01/09/2001 LA 4.0 4 M 12/26/2000 Admitted to hospital on 12/6/00 with cellulitis to left arm which was red and swollen with tenderness. Y 2 Y 12/04/2000 12/05/2000 1 PVT UNK URI LA001202 1
0164505 01/09/2001 KY 74.0 74 M 01/04/2001 Guillain-Barre Syndrome and later developed acute renal failure; started as pain in feet and legs. Admitted to the hospital on 12/26/00. Received IVIG and IV contrast which may be related to acute renal failure. Per F/U 5/1/01: BP 220/100. During her stay in the hospital, she gradually became weak and worse. Attempts to insert an IV line were made, but it was unsuccessful anf for this reason, we had asked MD to see her to insert a Port-A-Cath which was performed on 12/27/00. The pt was then given 8mg of Globulin, immunogloblin, 17 grams daily for 5 days over 16 hours. However, this was discontinued on 12/30/00 after 4 dosages, after she developed an elevated BUN and creatininie who had a history of was felt to be secondary to the immunoglobulin. Because of this, we had asked MD to see her who then started her on short-term dialysis. Slowly and gradually the rhythm failure improved. She remained stable and was then transferred to the skilled nursing facility on 1/16/01. Impression: Guillain-Barre syndrome, improving; Acute renal failure, transient secondary to the immunoglobulin therapy; hypertension. Y Y Y Y 12/09/2000 12/16/2000 7 MRI cervical spine-shows mild accentuation of cervical lordotic curve; MRI of thoric spine as well as the lumbosacral spine were nml; Cat Scan of brain-showed a small focus of low denisity signal in the posterior limb of the right internal coccal, consistent with an old lunar infarction; CT scan chest-showed 1cm in the terminate area of ill-defined density or infiltrate in the right upper lobe and another 3 to 4mm circumscribed nodule in the lingular segment of the left upper lobe; attempts to do the LP on 12/26/00 were unsuccesssful. With fluorscopic guidance, an LP was performed by the radiologist-slight elevation of the spinal fluid protein which was 4 to 7, spinal fluid chloride was 115, which were wnl; Gram stain, as well as, a smear for fungus-wnl. PUB UNK Cozaar, Lopid, Procardia XL, Lasix, potassium ibuprofen NONE Hypertension Arm swelling~Pneumo (no brand name)~1~74.00~In Patient 1
0164506 01/09/2001 CA 77.0 77 M 12/27/2000 The morning after the injection, the pt complained of fever 100F, aches, chills and felt stiff. The next day, he had fever, was pale and weak, so went to the doctor. He was hydrated with a pint of fluids and given Tylenol. Pulse was rapid. Had a low-grade fever for the rest of the week. On 12/18/00, went to the doctor. Pulse 190, low BP. Was sent to the hospital and put in ICU for 2 days, then sent home on Coumadin, Digoxin and Cardizem. (Did not have difficulty breathing). He is feeling better and has an appointment in 2 months. 60 day follow up states patient has shortness of breath and gets tired more easily. Per review of Hospital D/C Summary add diagnosis of 2:1 AV Block./awb Y Y 2 U 12/11/2000 12/12/2000 1 blood tests, chest x-ray, echocardiogram, electrocardiogram PUB PUB Lotensin NONE Hypertension. Add hyperlipidemia, BPH, heart murmur, rosacea per review of Hospital D/C Summary./awb CA000155 1
0164507 01/09/2001 OR 0.4 0 .4 M 01/04/2001 The patient had his vaccines on 12/20/00. He slept a lot for approximately 2 days, since then more subdued. The patient used to talk more, and laugh more now he requires stimulation to laugh. The patient is quiet unless he is hungry, needs a diaper change, or is stimulated by the mom, he was always easy going but now more so. No virus in the house. Y 12/20/2000 12/20/2000 0 NONE PVT PVT NONE NONE Slightly decreased tone on 12/20/2000 exam. 1
0164508 01/09/2001 RI 1.5 1 .5 F 01/02/2001 The patient has pain in the injection site, questionable abdominal pain, and a fever of 103. Y 11/14/2000 11/14/2000 0 PUB PUB 1
0164509 01/09/2001 IL 0.75 0 .8 M The patient became red and inflamed at the site of the injection, it also felt hard to touch. There was a hard knot that lasted 3 weeks even though the redness diminished in 36 hours. The patient's appetite was diminished and he was a bit listless for about 72 hours. Y 11/06/2000 11/07/2000 1 NONE PVT PVT Fever (99) the evening prior. NONE 1
0164510 01/09/2001 MI 0.4 0 .4 F 12/19/2000 The patient had swelling, and cellulitis at the site of injection (DTaP and Hib given in that leg). Treated with Keflex, and cool compresses. Recheck in 5 days. Y Y 12/07/2000 12/11/2000 4 PVT PUB URI Pilonidal / pre sacral dimple. 1
0164511 01/09/2001 VA 4.0 4 M 12/15/2000 The patient has 1 1/4 by 2 3/4 inch resolving hive in the left deltoid area, it first appeared approximately 48 hours after DTaP, IPV, MMR, and Prevnar vaccines. The hive occurred over DTap, and IPV site. No other symptoms. U 12/12/2000 12/14/2000 2 PVT PVT NONE Reactive airway disease in the past. 1
0164512 01/09/2001 39.0 39 M 12/29/2000 The patient had a localized reaction with a 20 minute induration, larger erythema with pruritus. Y Y 12/22/2000 12/24/2000 2 NONE MIL MIL NONE NONE NONE 1
0164513 01/09/2001 NJ 52.0 52 F 12/26/2000 The patient had a shot on 02/18/1999, then on 02/19/1999 she still had pain in her left knee with a lot of swelling. The patient reported to the doctor 03/01/1999, was treated with Relafen. The patient then went to the orthopedist 03/10/1999 and got a second shot, on 03/18/1999 she reacted again. The patient went back to the doctor on 04/15/1999, and the rheumatologist on 05/07/1999, she was treated with Relafen and Ultram. The patient has pain and intermittent swelling to this day. Y Y N 02/18/1999 02/19/1999 1 X-rays PVT PVT Synthyroid NONE Hypothyroidism 1
0164514 01/09/2001 WY 57.0 F 12/29/2000 The patient had a hard, tender, knot appear at the injection site that has moved to the back of the deltoid area. It is now less tender and some what smaller after the patient took several doses of Benadryl over the past 4 days and Hydrocortisone cream. Zero redness was noted. U 12/08/2000 NONE PUB PVT NONE NONE 1
0164515 01/09/2001 CA 66.0 66 M 12/21/2000 The patient states that approximately 24 hours after receiving the Flu vaccine he began having abdominal cramping. The cramping became severe so he went to his PDM. He was diagnosed with viral gastritis. He is now on bedrest, clear fluids and meds for relief of symptoms, and he continues to have a low grade temperature. He has a follow up appointment on 12/21/00. Y U 12/15/2000 12/16/2000 1 NONE PUB PUB Norvasc, Benadryl none Laryngectomy due to cancer, hypertension, elevated cholesterol, allergic reaction CA000154 1
0164516 01/09/2001 WI 46.0 46 F 01/03/2001 The patient received a vaccine and seven days after receiving it the patient began sneezing and developed a hive on her wrist. By midnight she had hives all over her whole body so she took Benadryl. The patient then developed more hives, so she went to see her doctor; where she was treated this was 25 hours after she received her vaccine. The patient went to the ER 35 hours after receiving the vaccine to be treated because the hives continued to develop. The patient was treated with Benadryl, Solu-Medrol, Zantac, Epinephrine, Albuterol nebulized inhalation, Prednisone, Ranitidine, and Zyrtec. Y Y 12/04/2000 12/04/2000 0 OTH PVT Allergies- Penicillin, Bactrim, Asprin. 1
0164517 01/09/2001 MD 50.0 50 M 12/06/2000 The patient developed a cough, redness, swelling and soreness at the site of the injection on 11/17/00 in the PM. The patient was seen by his family physician who prescribed cough medicine with codeine. The patient states the cough was somewhat alleviated but still complains of soreness and achiness in left arm to date. He has trouble lifting and or reaching. Pain in the shoulder still 12/29/00. N 11/16/2000 11/17/2000 1 NONE PUB PUB Hypertensive med NONE Diabetic Type II MD00013 1
0164518 01/09/2001 MD 72.0 72 M 12/07/2000 The patient had soreness in his arm that soon after developed into pain in the upper arm especially when raising his arm. A small knot still present at the site. No systemic symptoms. Plans to see PMD if no improvement. N 11/02/2000 11/05/2000 3 NONE PUB PUB NONE NONE NONE MD00014 1
0164519 01/09/2001 MN 23.0 23 F 12/07/2000 The patient had a fever of 102.4, swollen (the size of an orange), hard, hot, painful injection site. The patient also had achiness and feeling "wiped out." On 12/7/00 the fever was 99.6 this morning "feeling better". On 12/11/00 the patient recovered. Y Y 12/05/2000 12/06/2000 1 PUB PUB Insulin, Levo-Tabs, BCP NONE Allergic to Sulfa & Mins, Diabetes (when 13 yrs old), Sarcoid Cancer of bone (in remission). MN0008 1
0164520 01/09/2001 NY 71.0 71 F 01/02/2001 The patient had severe pain in the right arm about three hours after an injection. On 12/22/00 the patient fainted in the store. Arlington EMS was called they checked the patient out and then the patient went home, and notified her doctor that the pain continued. By 10 PM on 12/22/00 the patient arm from elbow almost to the shoulder, was so swollen, difficult to get shirt off. Arm also had become very warm and purple color. Swelling worse the next day. Swelling and soreness finally over on 12/27/000. Y 12/21/2000 12/22/2000 1 PUB OTH 1
0164521 01/09/2001 CO 10.0 10 F 12/28/2000 The patient had an allergic reaction at the injection site within 48 hrs. Y 12/19/2000 12/20/2000 1 CBC-wnl UNK UNK NONE NONE NONE 1
0164522 01/09/2001 NY 79.0 79 F 12/29/2000 The patient had diarrhea, vomiting, severe chills, headache and whole body aching all afternoon and all night on 12/07/00. The next day all of the symptoms were gone. Y 12/07/2000 12/07/2000 0 OTH OTH Trimterene, 2 baby Aspeqin 1
0164523 01/09/2001 OH 8.0 8 F 12/25/2000 The patient developed a rash from her shoulder on up, following vaccination on 12/18/00. The patient saw her PCP 12/19/00, she was treated with Benadryl. The rash increased to the trunk area through out the day, no trouble breathing, no hospitalization. Y 12/18/2000 12/19/2000 1 PVT OTH Insulin NONE Type I Diabetes Mellitus 1
0164524 01/09/2001 AR 10.0 10 M 10/12/2000 Child broke out in a rash from his knees down. No fever or other signs and symptoms. Took child to PMD, who gave Rx for prednisone. Pt broke out on entire body with rash within 24 hours. On 10/2/00, child was ok. Y Y 09/26/2000 09/26/2000 0 NONE PUB PUB Pred-Forte NONE Corneal transplant in 1997 AR0054 1
0164525 01/09/2001 CA 32.0 32 F 12/18/2000 Left arm tender with mild swelling. Y 12/14/2000 12/15/2000 1 PVT UNK Proventil, Serevent, multiple 1
0164526 01/09/2001 MN 48.0 47 M 11/27/2000 Pt has had stiffness and pain in all of his joints since receiving the 1st Hep-B injection. Has not seen MD. Encouraged him to see MD. He also had numbness then a few days later, he had sniffles. 2nd injection not given. U 10/11/2000 10/11/2000 0 NONE PUB PVT UNK NONE NONE MN00007 1
0164527 01/09/2001 MN 44.0 44 F 10/04/2000 1 week, post vax, she has pain in her left arm. Pain if felt during any movement of her arm. Pain is present even when arm is still, it is exacerbated with movement. Not tender to touch. U 09/20/2000 09/27/2000 7 NONE PUB PUB NONE NONE NONE MN00005 1
0164528 01/09/2001 MN 36.0 36 F 09/18/2000 Large lump, sore arm, shooting pains. U 09/14/2000 09/15/2000 1 PVT UNK 1
0164529 01/09/2001 MN 33.0 33 M 07/18/2000 Fever, swelling is not yet recovered. Y N 07/15/2000 07/16/2000 1 UNK OTH Broken collar bone 1
0164530 01/09/2001 WI 25.0 25 F 12/20/2000 Rash on chest, neck and right side; pallor; swelling of hands at 13:35; emesis at 14:00; flu-like symptoms for 24 hours, post vax. Y 12/20/2000 12/20/2000 0 OTH PVT NONE NONE Flu-like symptoms~Hep A (no brand name)~1~24.00~In Patient 1
0164531 01/09/2001 KS 18.0 18 M 12/11/2000 2 days, post vax, there was a hard, reddened area 2 3/4" X 3". Temperature spiked to 102.3F, 37 hours, post vax. Y 12/04/2000 12/05/2000 1 OTH OTH Motrin 400mg tid prn NONE NONE 1
0164532 01/09/2001 IL 2.0 2 .8 M 12/28/2000 States right leg, from knee to groin area, is swollen approx. 2 X larger than normal. No increased erythema or induration noted. Doesn't appear to cause problems with walking. Swelling noted on 12/7/00 PM. Y 12/06/2000 12/07/2000 1 NONE PUB PUB NONE NONE NONE 1
0164533 01/09/2001 FL 43.0 43 M 12/27/2000 Fever of 103F, palpitations, diarrhea, muscle pain, headache, anorexia, redness at the site of injection. Y 12/13/2000 12/16/2000 3 PVT PVT NONE NONE 1
0164534 01/09/2001 AK 50.0 50 F 01/02/2001 Severe headache, tiredness, dizzy, short of breath at times, heart palpitations, weakness and nausea. Y 12/27/2000 12/29/2000 2 OTH PVT Prozac, Ecotrin, vitamin C, multiple vitamins NONE Clinical depression, had a reaction to Demerol, once. 1
0164535 01/09/2001 ME 0.2 0 .2 F 12/18/2000 Fever Y Y 12/13/2000 12/13/2000 0 PVT PUB NONE 1
0164536 01/09/2001 MI 66.0 66 F 01/04/2001 Pt states it started as a 15cm "lump" and continued to spread. Today, pt has a 60mm X 60mm red, raised circle, warm to touch. PA examined pt's circle area with pen and instructed to RTC on 1/5/01 for evaluation. Pt to apply ice prn and take Benadryl as directed. U 12/27/2000 12/28/2000 1 PVT PVT Plendil, Maxzide NONE 1
0164537 01/09/2001 PA 4.0 1 .0 F 01/04/2001 Developed chickenpox lesions all over the face, back, trunk and in genital area. Px: oatmeal baths and Benadryl; had immunization on 8/5/97. Y 08/05/1997 12/27/2000 1240 NONE PVT PVT Claritin NONE NONE ~Varicella (Varivax)~1~2.50~In Sibling 1
0164538 01/09/2001 GA 46.0 46 F 12/26/2000 Localized erythema, edema and tenderness lasting 3-4 days, relieved by warm compresses and ibuprofen. Saw doctor and return visit on 12/22/00. Y Y 12/19/2000 12/20/2000 1 PVT PVT Injury from cat bite Allergic to sulfa and codeine 1
0164754 01/09/2001 CA U 08/31/2000 A pharmacist reported that several pt's received an expired dose of Orimune between 7/5/00 and 7/31/00. The onset of unspecified adverse events occurred within the same time frame. The Orimune expired 7/1/00. As of 8/24/00 no further information was available. Additional reports will be generated. U 07/05/2000 07/05/2000 0 UNK OTH OTH UNK UNK UNK HQ0332928AUG2000 1
0164541 01/10/2001 FL 30.0 F 01/08/2001 Information has been received from a health professional concerning a 30 year old female who was inadvertently vaccinated with a double dose of pneumococcal vaccine 23 (1ml). Subsequently, the pt experienced a severe asthma attack. She was referred to the ER for treatment. The pneumococcal vaccine 23 polyvalent had expired in May 2000. The severe asthma attack was considered a "Significant Medical Event". Y U 10/26/2000 10/26/2000 0 UNK OTH OTH UNK UNK WAES01010258 1
0164542 01/10/2001 NM 1.08 0 1 M 12/06/2000 The pt was hospitalized for thrombocytopenia, platelets were 14,000 on admission. Was re-hospitalized for platelets below 50,000. Per F/U 6/21/01: The mother had taken the pt to the doctor on 8/8/00, after noticing that the pt had a bruise on his chest that was increasing in size. She did not know how the bruise began. She stated that she had put him to sleep on 8/7/00 and when he woke up, she noticed the bruise. The pt has a history of bruising easily beginning at 6 months of age. The mother states that the pt is very active, plays hard and gets bruised easily. In the past month, she has also noticed that the pt has had epistaxis X 2 and in the past few days, he had a small amount of bleeding from his gums. The pt is twin number 1 of a pair and his sister has not had any similar problems. The pt has never seen a specialist regarding his bruises. He had no hematemesis, no hematuria and no blood in his stools. The mother also states that the pt has had 18 ear infections in the past year. He was not treated with PE tubes for these infections. His twin also had recurrent ear infections but not as many. Prior to admission, the pt had no fever, nausea or vomiting and no rhinorrhea or cough. On exam: The pt had a erythematous, papular rash present over perianal area surrounding buttocks. Skin with multiple bruises in different stages of healing and petechiae on the chest and face. Per mother, he was having more difficulty walking than usual. After IV IP, the pt responded to IV IG and after approx. 20 hours, platelets came on up. The pt should follow-up in Hematology Clinic and also be seen immediately and have is platelets checked, if he has further brusising and bleeding. Y Y Y 8 Y N 06/30/2000 08/05/2000 36 Multiple platelet counts-low; bone marrow-nml; viral serology-wnl PUB PUB NONE Diaper rash; Bleeding from his gums and epistaxis; also bruising prematurity, #1 of twins; Per F/U 6/21/01: Otitis Media and pulmonary hypertension. NM120001 1
0164543 01/10/2001 TN U 01/04/2001 "A territory representative reported that an infant received Prevnar, Acel-Imune, Hib-Titer and IPOL vaccines on 8/29/00. Approx. 24 to 36 hours, post vax, the parents observed that the infant no longer responded to noise. No further information was available at the date of this report." U 08/29/2000 08/30/2000 1 UNK PVT OTH UNK UNK U2001000180 1
0164544 01/10/2001 NY 1.25 1 .3 F 01/05/2001 "A mother reported that her 15 month old daughter received Prevnar and IPV vaccines on 10/20/00. On 10/30/00, the child experienced a 'seizure type episode'. Approx. 4 hours later, she had 'unexplained tremors' while in an ER. Convulsion is considered to be "Medically Important". Y U 10/20/2000 10/30/2000 10 electroencephalogram - nml OTH OTH NONE UNK U2001000220 1
0164545 01/10/2001 FL 60.0 60 M 12/28/2000 Post vax, of my 1st Lymerix shot, I experienced significant redness and swelling at the injection site which lasted about 3 days. More importantly, I began to experience joint stiffness and pain in my hands, shortly thereafter. Prior to the shot, I had not had any such problems. I assumed the stiffness was temporary and therefore, had the 2nd shot on 6/11/99. The joint stiffness, inflammation and pain in my hands continued to increase. Eventually, I was referred to a rheumatologist who thinks I have some type of rheumatoid arthritis (even though the symptoms only began days after the 1st Lymerix shot) and started me on NSAIDS. The NSAIDS caused a rise in my blood pressure to the point that I had to start taking medication for that, too. I know that the Lymerix triggered some type of auto-immune reaction! Y Y N 05/20/1999 05/27/1999 7 RA Factor-High; ANA-Neg; Sed Rate-High PUB PVT ASA, Voltaren, cytotec, diltiazem NONE allergy to dust, molds, pollen 1
0164546 01/10/2001 MI 36.0 36 F 01/03/2001 Information has been received from a physician concerning a 36 year old white female who in July 2000, was vaccinated with varicella virus vaccine live. Four weeks later, the pt experienced angioedema and hives. It was reported that since that time, each week on the same day of the week, Thursday, the pt experienced hives. It was noted that since approx. 10/00, the pt has also experienced slight laryngeal edema. Also, it was reported that the pt feels that since the vaccination in July 2000, she has experienced an increase in her "mild asthma". Unspecified medical attention was sought. Follow-up information from the physician, indicated that the pt was vaccinated with the 1st dose of varicella on 7/20/00. It was reported that there was no illnesses at the time of vaccination. On 8/20/00, the pt developed generalized hives, lip angioedema, ankle and shoulder swelling, and a mild worsening of asthma. No improvement was seen with aggressive antihistamine therapy. The pt developed laryngeal edema and was placed on oral steroids with good response. The physician considered the events life threatening and "Other Medical Events". As of 11/14/00, the pt recovered from the events. No further details were provided. Y Y Y 07/20/2000 08/20/2000 31 Complement assays-nml; Complete blood cell-nml; Erythrocyte-32 increased; Partial blood chemistry-nml; Serum ANA-nml; Thyroid function test-nml PVT OTH UNK Gastrointestinal bleeding; asthma; seasonal allergic rhinitis WAES00102294 1
0164548 01/10/2001 CA 1.0 1 .0 M 01/08/2002 Information has been received from a consumer concerning an approx. 1 year old male, with no known drug allergies and a history of three tympanic membrance surgeries, tonsillectomy and adenoidectomy, who in approx. 9/98, was vaccinated with MMR II. The pt's mother reported that the night of the vaccination, she woke up to the child making a strange humming sound. She reported that she went to the crib and the child looked swollen and was hot to the touch. The pt's mother took a rectal temperature and the result was 105.8F. She bathed him in tepid water and gave the child Tylenol. The pt's mother took him to the physician, who did not feel the events were vaccine related. Later that evening, it was reported that the child developed a 'measles-like rash' that went away within a couple of hours. The child had computed axial tomography scan in November 2000 that showed "hypoplasmia (organ not specified) and other significant abnormalities" on the right side only (pre-existing conditions)(follow-up in process). The report mentioned possible old injury or insult. The patient can not hear with the right ear and is losing his eyesight It was reported that the patient is always sick upon internal review the patient's experience were determined to be Other Medical Events. FOLLOW-UP information, the physician reported that the patient was vaccinated with measles virus vaccine live (-) mumps virus vaccine live (-) rubella virus vaccine live (second generation) on 10/02.1998. Concomitant vaccination on 10/02/1998 included varicella virus vaccine live. Patient also received tuberculin purified protein deriative (PPD) on 10/02/1998. The physician reported that the patient was seen in the clinic on 10/07/1998 with low grade fever (T. 99.6/Tympanic) and was diagnosed with bilateral otitis media (BOM), tonsillitis and rash (? post vaccination vs. viral). A complete blood count (CBC) was done and was consistent with a viral infection. Chest x-ray was negative. The physician stated "I don't feel there was any adverse reaction". Additional information has been requested. In follow-up, the physician reported tha the pt was vaccinated with MMR on 10/02/1998. Concominant vaccination on 10/02/1998 icluded varicella virus vaccine. Pt also received tuberculin purified protein derivative on 10/02/1998. The physician reported that the pt was seen in the clinic on 10/07/1998 with low grade fever (99.6 deg. F) and was diagnosed with bilateral otitis media, tonsillitus and rash post vaccination. A complete blood count CBC was done and was consistent with a viral infection. Chest x-ray was negative. Antistreptolysin 0 titer, blood culture and Epstein Barr virus titers were negative. The physician stated, "I don't feel there was any adverse reaction." Additional info has been requested. Y N 10/02/1998 10/02/1998 0 CT Scan-11/00 that showed 'hypoplasia (organ not specified) and other significant abnormalities' on the right side only (pre-existing conditions) (follow-up in progress). Fever of 105.8F. OTH OTH PPD Adenoidectomy; tonsillectomy; tympanic membrane surgery; hypoplasia WAES00121734 1
0164550 01/10/2001 CA 26.0 M 12/28/2000 Information has been received from an RN concerning a 26 year old male that while hospitalized for a splenectomy in 1996, was vaccinated with pneumococcal vaccine 23 polyvalent. Approx. 30 seconds later, the pt experienced a drenching sweat and visual disturbances. The pt was treated with Benadryl therapy. The physician felt that the pt had an allergic reaction due to the phenol component in pneumococcal vaccine 23 polyvalent. Upon internal review, drug allergy, was determined to be an "Other Medical Event". Additional information has been requested. In F/U the Physician reported that the pt's experience was reported to him by the pt and the event happened in another state and not at this physician's office. Further information is not expected. The code of drug allergy has been changed to anaphylaxis, a labeled event. Therefore, this report is no longer meets the criteria for expediated submission. Y U UNK UNK UNK Hospitalization for splenectomy at the time of vaccination. WAES00121626 1
0164552 01/10/2001 AZ U 12/28/2000 Information has been received from an LVN concerning a child who in approx. June, 1999, was vaccinated with varicella virus vaccine live. Subsequently, the pt experienced seizure and brain swelling and was hospitalized. A brain biopsy was scheduled to determine course of treatment, therapy and cause. It was reported that the pt's mother was told that the pt's experience was related to therapy with varicella virus vaccine live. Additional information has been requested. Further FU: the physician's office reported that the child was not one of their patients. Y U 06/01/1999 Brain biopsy-pending UNK UNK UNK UNK WAES00121751 1
0164553 01/10/2001 IL 80.0 80 F 01/04/2001 The pt experienced a "large tight knot" at the site. The pt was seen by her physician. The are from the deltoid to mid humerus with induration, erythema that blanches to pressure and pain. The diagnosis was possible cellulitis. The pt's physician prescribed Cefzil for seven days and ice to the area for two to three days. The next day improvement was noted. Upon internal review induration,erythema and possible cellulitis was determined to be "other medical events". Additional information has been requested. Y Y 10/31/2000 10/31/2000 0 UNK UNK Celebrex, Lopid asthma, COPD, hypercholesterolemia, hypertension, allergy to sulfa, atherosclerosis WAES00122113 1
0164555 01/10/2001 PA 50.0 50 F 12/12/2000 Between 17:00 and 18:00, had red blotch at site (LA) and it was hot/ice applied. At 03:45 had dizziness, palpitations, face and throat were hot, sore and itchy throat and flushed. Went to ER. BP was 180/110; HR 136. About 15 minutes later, had chest pain and was given nitrodrip, Lopressor IV. Had a headache and was given Tylenol and admitted to tele. pressure down. Home x 1 week and returned with experiences same. Achy/sore throat, increased BP and was put on Toprol. Y Y 1 Y 11/30/2000 11/30/2000 0 EKG-showed sinus tachycardia; Stress test-nml per employee PVT OTH E-Vista NONE menopause, arthritis Local reactions x 2~Influenza (Seasonal) (no brand name)~~0.00~In Patient 1
0164557 01/10/2001 WI 80.0 79 F 11/22/2000 Pt called the assistant director and informed her that she was hospitalized after receiving vaccines for congestive heart failure. Y Y 3 Y 11/09/2000 11/09/2000 0 NONE OTH PUB K-Dur, aspirin, atenolol, Vasotec, furosemide, ranitidine, Glucotrol XL, allopurinol NONE congestive heart failure, diabetes, hypertension, arthritis, constipation, arrhythmia, angina 1
0164558 01/10/2001 NY 63.0 63 M 11/20/2000 Right deltoid muscle red and inflammed. Pt went to local ER and was admitted with cellulitis of right arm. Y Y 1 Y 11/17/2000 11/19/2000 2 cellulitis PUB PUB UNK NONE UNK 1
0164562 01/10/2001 2.7 F 01/05/2001 Information has been received from a healthcare professional concerning a 32 month old female who was vaccinated with a dose of haemophilus b conjugate vaccine and subsequently, the pt developed haemophilus type b infection despite vaccination and meningitis. The pt's haemophilus type b infection despite vaccination and meningitis, have been determined to be "Other Medical Events". The outcome of the pt's events was reported as unknown. No further information is available. U OTH OTH UNK UNK WAES00122165 1
0164563 01/10/2001 AK 74.0 74 F 11/15/2000 Hospitalized 11/3/00 for 12 days. Discharged on 11/15/00 and re-admitted on 11/19/00 with the flu. Returned home on 11/28/00. Admitted on 11/3/00 with severe respiratory distress. Diagnosed with exacerbation of COPD, Anxiety, Depression, Chest Pain Y Y 12 Y 11/02/2000 11/03/2000 1 UNK UNK Lasix, Potassium,Lanoxin, Quinine Sulfate, Nitrglycerin, Alrovent, Albuterol, Severant, Flovent NONE Angina, COPD AK200104 1
0164564 01/10/2001 AK 1.5 1 .5 F 11/13/2000 Started getting sick on 10/22/00. Clingy and irritable and thought she was teething. On 10/26/00, she had diarrhea that started with a fever. On 10/27/00 at about 21:00, child started having seizures. Taken to ER and they couldn't start an IV and doctor cut down to ankle. Continued having seizures. Had 1 hour long seizure. Was told that she stopped breathing and was intubated. Y Y Y 6 Y Y 10/10/2000 10/22/2000 12 MRI, CAT Scan, Spinal Tap in ER PUB PUB NONE NONE AK200102 1
0164565 01/10/2001 NY 1.5 1 .5 M 12/11/2000 6-8 hours post vax pt developed a rapidly rising fever and febrile seizure. Pt looks well. HHVG culture pending. Y Y 12/08/2000 12/08/2000 0 HHVG culture pending - FU received states test is Positive PVT UNK viral syndrome with fever 1
0164566 01/10/2001 WV 0.75 0 .8 F 01/05/2001 Pt became lethargic and experienced a fever of 101. Y 10/04/2000 10/04/2000 0 PVT PVT NONE 1
0164567 01/10/2001 MN 1.0 1 .0 F 11/30/2000 Pt became fussy and remained so for the afternoon. Pt cried inconsolably for one hour. Pt taken to urgent care and exam was normal. Y 11/30/2000 PVT PVT NONE NONE 1
0164568 01/10/2001 MN 1.25 1 .3 F 10/25/2000 Pt began screaming continually for 5 hours. Y 10/23/2000 PVT PVT URI Inconsolable crying with DTAP 08/27/99 inconsolable crying~DTaP (no brand name)~1~0.00~In Patient 1
0164569 01/10/2001 NM 0.75 0 .8 F 11/02/2000 Pt developed a swollen, indurated area over left thigh at injection site 4 X 4 cm and a blotchy red rash on trunk. Pt was treated with Benadryl. Y Y 10/31/2000 11/01/2000 1 PVT PUB NM110002 1
0164570 01/10/2001 NM 1.8 1 .9 M 12/22/2000 Pt developed swelling and redness of left thigh. Y U 12/20/2000 12/22/2000 2 NONE PVT UNK URI NM010001 1
0164571 01/10/2001 OK 0.2 0 .2 M 12/19/2000 Pt experienced inconsolable crying for 3 days. No treatment was given. Y 12/06/2000 12/07/2000 1 NONE PVT PVT NONE NONE 1
0164572 01/10/2001 CA 0.2 0 .2 F 12/15/2000 Parent reports that 8 hours post vax the pt developed a 100F temperature. Two days post vax pt was seen my MD with a quarter size lump on left thigh, sleepy and difficult to awaken. Y 12/13/2000 12/13/2000 0 PVT PVT NONE NONE 1
0164573 01/10/2001 GA 1.3 1 .2 M 12/29/2000 Pt experienced small seizure activity. Arms and legs would jerk, eyes unfocused. Y Y 12/14/2000 12/22/2000 8 CXR, Blood work done PVT PVT Zyrtec, Rhinacort 1
0164574 01/10/2001 CA 79.0 79 F 11/20/2000 Pt experienced bruising, redness, swelling and painful are at injection site. Pt complained of burning and stinging after injection. Pt was referred to doctor. Y U 11/15/2000 11/15/2000 0 OTH OTH diabetes meds NONE DM, HTN 1
0164575 01/10/2001 MA 63.0 63 F 11/09/2000 Pts right arm became red and swollen. Swelling extended to wrist, elbow and under arm. Pts arm doubled in size. Pt was seen by covering physician and then primary doctor on 11/06. Y Y 11/03/2000 11/03/2000 0 PUB PUB NONE 1
0164576 01/10/2001 AR U Pt reported that he was not feeling well over the weekend following vax. Pt began feeling very ill, with fever, chills, body aches, severe headache on Tuesday evening while at work. Pt was unable to work on Wednesday due to fever up to 102.4, chills, severe arthralgia, severe myalgia, headache, weakness, joints were hot, and dizziness. This lasted the entire day. Pt returned to work on Thursday, feeling better, but still with milder symptoms. Pt has had the flu vax the past 3 years without incident. Y 10/27/2000 10/28/2000 1 PVT OTH NONE AR0052 1
0164577 01/10/2001 NC 37.0 37 F 11/30/2000 Approximately 8 hours post vax pt began to experience itching all over and turned red. Pt took Benadryl and went to bed. The following two days the symptoms of itching and redness continued with no rash. Y 11/21/2000 11/21/2000 0 OTH PVT Claritin, Prilosec, iron supplement NONE anemia, reflux, seasonal allergies 1
0164578 01/10/2001 PA 71.0 71 F 12/13/2000 Pt claims extreme weakness about 3 days post vax. Pt has H/O fibromyalgia with extreme weakness and has severe depression. Physician has documented phone calls in the chart from 2 weeks prior to vax where pt complained of increased fatigue and weakness and pt had stopped several of her prescriptions prior to this incident. N 10/12/2000 10/15/2000 3 NONE PVT PVT Verapamel, ????, Nervasc, Bumex, Atenolol, Premarin fibromyalgia, HTN CAD, depression, fibromyalgia, DTD, chronic fatigue 1
0164579 01/10/2001 TX 87.0 87 M 12/21/2000 One day post vax the pt developed macropapular scattered areas, scattered around right deltoid area from .5 to 1.5 cm. Diagnosis: allergic reaction. Pt was treated with Allegra U 12/20/2000 12/20/2000 0 PVT PVT IsosorbMono, Toprol, Nitro Quick increased PSA, knee pain cholelithiosis, NN anemia, Hx Cardiac Arrythmia 1
0164580 01/10/2001 OH 78.0 78 F Pt complained of confusion, disorientation and aura-like symptoms following flu shot. Felt sick to stomach evening of vax. Increased anticonvulsant medication as needed. Y U 10/31/2000 11/02/2000 2 EEG scheduled for 11/30/2000 PUB PUB Dilantin, Thyroid NONE seizure disorder, history of thyroid surgeries 1
0164581 01/10/2001 IA 50.0 50 F 12/19/2000 One day post vax the pt awoke with inability to control movement in the right arm and leg for about 12 hours in the the arm and about 6 hours in the leg. Vision was also blurred in both eyes for about 12 hours. Y 12/15/2000 12/16/2000 1 NONE OTH PVT Paxil, Flovent, Prempro, Imitrex, Danocet, Maxair PCN, Sulfonamide, scallop allergy 1
0164583 01/10/2001 CA 26.0 26 F 11/16/2000 Pt became itchy and sweaty. Developed hives and lump in throat. Pt was treated with Benadryl. Y 11/15/2000 11/15/2000 0 PUB PVT NONE 1
0164584 01/10/2001 WV 40.0 40 M 12/06/2000 Pt stated that one day post vax he developed generalized rash with intense itching. Pt was treated at local ER with prednisone and Benadryl. Physician stated rash from the flu shot no levoquin. Rash and itching all gone in 24 hours. Y Y 11/30/2000 12/01/2000 1 Blood work at ER OTH PVT Levoquin starting 14 days prior to vax NONE 1
0164585 01/10/2001 OH 37.0 37 F 01/05/2001 Pt experienced soreness after vax. Pt complained of red, swollen area 3-4" on arm one day post vax. Y 01/04/2001 01/05/2001 1 NONE OTH PVT UNK NONE allergy to pollen 1
0164586 01/10/2001 IL 70.0 70 F 11/18/2000 Pt states had severe chills Friday evening and all day Saturday. Pt did not take temperature. Pt states are swelled up into neck and down to elbow twice the normal size. Had rash on arm, shoulder and under arm. Pt unable to move arm. Y 11/03/2000 11/03/2000 0 PUB PUB arthritis meds NONE IL00071 1
0164587 01/10/2001 IL 70.0 70 M 11/09/2000 Pt experienced pain in left arm starting the evening of vax. Pt treated with aspirin. One day post vax, pt woke up still in pain, but minimal unless movement. Area from injection site down to elbow was swollen, red and hot. Pt treated with ice. U 11/07/2000 11/07/2000 0 UNK UNK IL00072 1
0164588 01/10/2001 TX 33.0 33 F 12/29/2000 Pt experienced needle, prickly like, itchy sensation all over with headache. Pt also experienced some pressure/uneasiness in throat/breathing. Y 12/20/2000 12/20/2000 0 PVT OTH Allegra, Celebrex NONE allergic to nickel, mercury compound 1
0164589 01/10/2001 NM 77.0 77 F 11/16/2000 Pt began generalized itching of entire body the evening of vax. Pt developed rash, red, raised welts over most of body on day post vax; worse around neck and upper back. Three days post vax skin is flaking off and itching continues. Y 11/13/2000 11/14/2000 1 PUB PUB Allegra, Indural, Adican, Loratab diverticulosis-ostomy (08/21/2000); IBS; hypertension PCN, Sulfa, Cipro, Flagyl NM110003 1
0164590 01/10/2001 GA 11.0 11 F 12/08/2000 Pts mother states after injection pts left arm became warm, slightly swollen, and itchy. Was seen by physician due to warmth and swelling. No treatment ordered. Y 11/14/2000 12/08/2000 24 NONE PUB PUB Vanceril NONE GA00145 1
0164591 01/10/2001 GA 69.0 69 F 12/01/2000 One day post vax pt woke up with a swollen, red and sore arm. Pt applied ice and took Tylenol. Left arm still red and sore to touch., Advised to apply warm compresses and Tylenol. U 11/27/2000 11/28/2000 1 NONE PUB PUB Tamocifin NONE Cancer of right breast; bee stings and green pepper allergies GA00140 1
0164592 01/10/2001 IL 46.0 46 F 12/21/2000 Pt experienced headache the evening of injection. Pt observed arm which was red, raised and tender at injection site. Pt was seen by physician one day post vax. Area at injection sit 1.5 - 2" circumference 3". Pt treated with Trimamcinolone cream. Y Y 12/19/2000 12/20/2000 1 NONE PUB PVT BP med - Teveten and Zoloft NONE 1
0164593 01/10/2001 OH 73.0 76 F 11/20/2000 Patient noted that within 24-48 hours she developed ecchymosis at site on right deltoid. Two days post vaccine, patient noted an approximately 8 cm diameter warmth and redness on the anterior, lower portion of her upper right arm that was itching. Y 11/16/2000 11/18/2000 2 PUB PVT Isosorbide, Lopressor, Nitro PRN, ASA 325mg 1 bid NONE Streptokinase allergy and possible allergy to antibiotic 1
0164594 01/10/2001 MA 29.0 29 M 11/07/2000 Patient developed rash on hands, feet and trunk that was tender and painful. He developed myalgias and was unable to walk secondary to pain. N 11/20/2000 11/23/2000 3 NONE PVT UNK doxycycline NONE NONE 1
0164595 01/10/2001 MA 32.0 32 F 11/16/2000 Patient developed erythema, swelling and increased warmth in right upper arm. She had right upper extremity inflammation with probable cellulitis. Y 11/13/2000 11/14/2000 1 PVT UNK Asthma, lesion right index finger 1
0164596 01/10/2001 VA 11.0 11 F 11/28/2000 Spoke with secretary at elementary school. Child was complaining of difficulty breathing, skin pale, blue lips, cold hands and eyes bulging. Mother stated that child also had a rash on chest. On 11/28/00, per call to mother, child is doing fine; no rash. Will return to school on 11/29/00. ER MD dx'd reaction to Hep-B vaccine. Per call to mother on 11/29/00, she is taking child back to doctor today for swollen eyes; not sure if vaccine related. Y Y 11/27/2000 11/27/2000 0 OTH PUB NONE Slight cold Allergy to icing on cake. 1
0164597 01/10/2001 MA 65.0 65 F 11/09/2000 Patient noted left arm to be extremely swollen, painful and red. She spoke to a physician at the ER where she worked, and he suggested that she may be allergic to a component of the vaccine. Y 11/03/2000 11/03/2000 0 NONE PUB PUB NONE 1
0164598 01/10/2001 MA 63.0 63 F 11/09/2000 Patient's left arm became extremely hot, red and swollen. The area of redness was 4 inches in diameter. She had pain from her wrist to her shoulder. She did not feel well. Y 11/03/2000 11/03/2000 0 PUB PUB NONE 1
0164599 01/10/2001 MA 65.0 65 M 11/09/2000 Patient developed a red, swollen, very painful arm that lasted one week. Y 11/03/2000 11/03/2000 0 PUB PUB NONE 1
0164600 01/10/2001 AZ 66.0 66 F 11/10/2000 Patient developed fever and erythema and tenderness at injection site. She also noted myalgia and nausea. Y 11/08/2000 NONE PVT UNK NONE Allergies to penicillin, sulfa and codeine 1
0164601 01/10/2001 NH 47.0 47 F 12/21/2000 Patient noted 1-2 days after vaccine that her left upper arm was swollen, hot, and red distally down the arm. U 12/19/2000 12/19/2000 0 OTH UNK 1
0164602 01/10/2001 PA 4.0 4 M 12/20/2000 Patient developed an 8 cm diameter induration, erythema and tenderness. Y Y 12/15/2000 12/16/2000 1 NONE PVT PVT NONE NONE NONE 1
0164603 01/10/2001 WV 10.0 10 M 12/21/2000 Mother noticed patient breathing hard in his sleep. He was warm to the touch and his heart was racing. He was taken to the ER but no treatment was done. Patient had a temperature of 100.4 degrees. He was given 2 tsp of Tylenol by his mother. Both of the patient's arms were pink, he felt dizzy and vomited once. Patient had stated that he felt funny in the car after receiving the shot. Y 12/20/2000 12/21/2000 1 NONE PUB PUB Allergy shots Cough Environmental allergies, milk allergy 1
0164604 01/10/2001 FL 1.25 1 .3 M 12/07/2000 Patient developed a 2.5 x 3 inch reaction on lower anterior left thigh. He had erythema and swelling. Y 11/30/2000 12/01/2000 1 PVT PUB NONE NONE Prematurity 1
0164605 01/10/2001 FL 3.0 3 M 12/08/2000 Patient developed swelling of right upper anterolateral thigh. U 12/04/2000 12/07/2000 3 PVT PUB NONE NONE 1
0164606 01/10/2001 CA 4.0 4 M 12/13/2000 Patient developed localized swelling and redness to left arm. It feels warm to the touch. Y 12/11/2000 12/11/2000 0 PUB PUB NONE Developmental delay 1
0164607 01/10/2001 AZ 1.08 1 .1 F 11/29/2000 Patient developed a varicellaform rash 26 days after administration of Varivax. Y 10/31/2000 11/26/2000 26 NONE PUB PUB NONE NONE NONE 1
0164608 01/10/2001 FL 12.0 12 M 11/29/2000 Complaining of pain in both knees, warm to touch. Rash noticeable on both arms (inner aspect) and also on both legs. Y U 11/28/2000 11/29/2000 1 CBC PUB UNK NONE NONE NONE 1
0164609 01/10/2001 FL 12.0 12 M 09/14/2000 Approximately 3 weeks post vaccine, patient reported to his mother that for 2 weeks after receiving his vaccines he felt really tired, weak, and legs felt like rubber. He felt like he could not stand, he wanted to run but could not. Y 08/18/2000 08/25/2000 7 PUB PUB Multivitamin NONE NONE 1
0164610 01/10/2001 AR 11.0 11 F 11/17/2000 Approx. 15 minutes, post vax, pt fainted, hitting head on floor. No prior complaint of dizziness. Physical exam performed showed no signs of severe reaction ie hives, wheezing, SOB or decreased blood pressure. Y 11/16/2000 11/16/2000 0 Neurological status assessed, vital signs UNK UNK Head cold per mother NONE 1
0164611 01/10/2001 PA 2.0 1 .5 M 12/26/2000 Scattered scabbed papules and vesicles on right abdomen with erythematous base, single vesicle papule, pain in right abdomen that started the week of 12/19/00. Pain increased and had a fever of 101F. On 12/25/00, MD stated he has vaccine associated shingles; now resolving. Pt to call if worse. U 07/16/1999 12/26/2000 529 NONE OTH PVT NONE NONE 1
0164612 01/10/2001 CA 25.0 25 F 12/21/2000 Erythema 16cm X 18cm on right arm with induration at DT site. Y 12/19/2000 12/20/2000 1 NONE PUB PVT NONE NONE NONE 1
0164613 01/10/2001 KY 10.0 10 M 11/29/2000 Hives from head to thighs, onset approx. 3 hours, post vax. Given steroid shot at doctor's office about 7 hours, post vax. Hives improved within 1 hours of steroid shot. Monitored closely for the next 48 hours for any other reaction. Y Y 11/03/2000 11/03/2000 0 PUB PUB NONE NONE 1
0164614 01/10/2001 CA 0.2 0 .2 F 12/22/2000 Unconsolable crying U 12/22/2000 12/22/2000 0 PVT PUB NONE NONE NONE 1
0164615 01/10/2001 KY 40.0 39 F 12/18/2000 Pt states had severe headache and stiff neck day after injection. Pt states not sure how long. Took Tylenol and Advil no physician visit or ER. Y 07/06/2000 07/07/2000 1 PUB PVT 1
0164616 01/10/2001 IN 34.0 34 F 12/07/2000 Ten days post MMR vax pt started with a fever of 101, sore throat and generalized red rash with itching. Y Y 11/10/2000 11/24/2000 14 Mono 16.6, WBC 4.2, RBC 5.20 Neut 28.3, Lymp 54.1 PVT PVT UNK 1
0164617 01/10/2001 MN 39.0 39 F 12/28/2000 Pt noted ears plugging up and throat closing while driving home, turned around - sx's subsided when she came into clinic HR 86, B/P 140/90, RR 18. Slight anxious talked with state immun. hot line, MD in clinic discharged after watching 1/2 hour. No sx's. Y Y 12/27/2000 12/27/2000 0 NONE PVT UNK NONE NONE NONE 1
0164618 01/10/2001 KY 10.0 9 F 01/04/2001 Child had vax at 10:30 had lunch at 12:00 noon c/o itching, eyes swollen, red & tearing, hives on face, scratchy throat at 1:00 pm. Benadryl 50 mg given. Within 15 mins hives and swelling was better. Mother took child to MD. Y Y 01/04/2000 01/04/2001 366 OTH PUB NONE NONE NONE KY2001001 1
0164619 01/10/2001 NM 26.0 21 F 11/12/2000 Pt presented at clinic on 11/2/00 injection site was presenting with redness and swelling 11/2 inch circumference 1 cm induration /4c redness. Y U 10/30/2000 10/30/2000 0 OTH OTH NM110001 1
0164620 01/10/2001 GA 6.0 6 M 08/01/2000 7/31/00 Vax given, 8/1/00 left arm red, fevered, swollen, irriatable, 8/2/00 reported to WCHD, redness and swollen 90mm/75mm. Hurts to raise left arm advised Tylenol and warm compress. Y 07/31/2000 08/01/2000 1 PUB PUB NONE NONE GA00150 1
0164621 01/10/2001 GA 10.0 10 F 12/12/2000 The pt's mom states the pt developed hives, itching, fever of 103 and nausea. No appetite. Resolving post Benadryl and Motrin by 12/12/00. Onset the evening of the shot. Y 12/11/2000 12/11/2000 0 NONE PVT UNK NONE NONE NONE GA00149 1
0164622 01/10/2001 GA 1.25 1 .3 M 11/30/2000 Parent noticed in am post vax that right leg was swollen and hot to touch (tennis ball sized lesion) Y 11/28/2000 11/29/2000 1 NONE PUB PUB NONE NONE NONE GA00148 1
0164623 01/10/2001 GA 1.2 1 .2 M 12/15/2000 12/15/00 Phone call from mother stating that she took pt to ER with 100.5 temp. and baseball size knot on right thigh state, given antibiotic for infection form ER MD. 13:00 lesion measured 8cm x 13cm, red, hot to touch , cellulitis, mother will see MD today to seek intervention. Y U 12/13/2000 12/14/2000 1 NONE PUB PUB NONE NONE NONE GA00146 1
0164624 01/10/2001 GA 44.0 4 F 12/08/2000 Rash all over both legs and stomach denies any itching and temp. Mother very concerned about her child. 12/8/2000 rash no treatment needed. Resolving at this time. Y 11/06/2000 12/06/2000 30 NONE PUB PUB NONE NONE GA00144 1
0164625 01/10/2001 GA 1.9 1 .9 M 11/30/2000 Child given shot in R deltoid mom noticed swelling in right deltoid Wed. afternoon mom rubbed alcohol on right shoulder and applied warm compress to area. Y U 11/28/2000 11/29/2000 1 PUB PUB PPD by Parkdale, lot #45256220 NONE NONE GA00143 1
0164626 01/10/2001 GA 4.0 4 M 11/27/2000 Rt quarter size red, raised area no blister, slight itching, no soreness no SOB and no ER visit Y 11/14/2000 11/25/2000 11 NONE PUB PUB NONE NONE GA00142 1
0164627 01/10/2001 GA 36.0 36 M 12/05/2000 1:00 became light headed with dry throat and 1:15 states feeling better will advise MD of any further sx U 12/05/2000 12/05/2000 0 NONE PUB PUB NONE NONE NONE GA00141 1
0164628 01/10/2001 GA 1.3 1 .4 F 12/07/2000 12/4/2000 left arm became red and swollen. Y 12/04/2000 12/04/2000 0 NONE PUB PUB NONE NONE NONE GA00139 1
0164629 01/10/2001 GA 44.0 44 F 11/06/2000 Noticed swelling left upper arm radiation to left trapezes aching treatment was Motrin. @cm red area. N 11/02/2000 11/05/2000 3 PUB PUB Puncture wound left foot Allergic to MS GA00138 1
0164630 01/10/2001 MN 1.5 1 .5 M 06/27/2000 Whimpering in crib at 01:00 on 6/21/00. Mom attended to him and she found him semi-conscious, jerking with his arms and legs. The episode lasted 5 minutes. He became flaccid and went back to sleep. Has had no problem since seen by MD and had a normal exam. Y 06/20/2000 06/21/2000 1 PVT PVT NONE NONE 1
0164631 01/10/2001 MN 2.0 2 .3 M 07/06/2000 5.5cm erythematous and blistered area at injection site. Warm to touch. Y Y 06/21/2000 06/23/2000 2 WBC-14.1 PVT PVT NONE NONE NONE 1
0164632 01/10/2001 MN 44.0 44 F On 10/8/99, had severe local reaction, site swollen and tender to touch. Feels feverish and nauseated. On 10/13/99, still about 50 cents-sized lump. On 6/12/00, injection site was again sore and stinging and tender to touch after having a cold. Y 10/06/1999 10/08/1999 2 PVT PVT PCN allergy; history of pneumonia 1
0164633 01/10/2001 MN 65.0 65 F 08/11/2000 Pt had itching, redness and swelling at vaccine site for 10 days, post vax. Y 08/01/2000 08/10/2000 9 PVT PVT 1
0164634 01/10/2001 MN 1.5 2 .5 M 10/11/2000 Developed vesicular papules and fever, characteristic of varicella, 4 years, post vax. U 07/31/1996 10/01/2000 1523 NONE PVT PVT NONE NONE Febrile seizures 1
0164635 01/10/2001 AK 2.0 2 .4 F 12/18/2000 1 1/2" raised, red, blotchy area at injection site on right upper arm. 1 week, post vax, 2 pox on face. 3 pox on face, 2 weeks, post vax. No fever or runny nose. No other symptoms. Traveling forearms. U 11/28/2000 12/05/2000 7 PUB PUB NONE NONE NONE (Pt is a twin) Fever and fussy~Measles + Mumps + Rubella (MMR II)~1~1.25~In Patient AK200105 1
0164636 01/10/2001 AK 1.0 1 .0 M 11/20/2000 Approx. 12 hours, after MMR, child couldn't swallow; had a rash (pink, flush on skin) on lower park of knees only. Temperature 102F (rectal), sore throat, and wouldn't drink. Resolved 2 hours, after it appeared on it's own. Y 08/30/2000 08/31/2000 1 NONE PUB PUB NONE NONE NONE AK200101 1
0164637 01/10/2001 MN 21.0 21 F 01/02/2001 48 hours, post vax, pt presented to ER with redness and pain at site of injection, that was extending up towards her neck. Y Y 06/23/2000 06/24/2000 1 PUB PUB Paxil, BCP Laceration to right thumb Morphine allergy 1
0164638 01/10/2001 NY 1.2 1 .2 F 12/22/2000 Generalized rash within 24 hours, post vax. Also unable to console. On 12/22/00, pt still has light generalized fine pattern rash and red cheeks. Y Y 12/08/2000 12/09/2000 1 OTH PUB NONE NONE Eczema 1
0164639 01/10/2001 AK 2.0 2 .4 M 12/11/2000 On 12/11/00, received call from mom, inquiring about any known connection between Hep-A vaccine and seizures. Reports child's "body jerks" when tired. Began within 1 week of getting Hep-A #1 vaccine on 10/20/00. Initially occurred only when falling asleep (night time and nap time). She describes as "when you're falling asleep and someone startles you". Family went on vacation 11/3/00, and on 11/4/00, child began having same thing during the daytime ("a few times a day"). Now it is occurring up to 30 X an hour. Seems to occur when most fatigued. Seen by doctor when she travels to this county clinic and the doctor has witnessed 1 time. Scheduled to have MRI on 12/21/00. Mom trying to think of anything new and different in the past 2 months. It is of note, that this pt's sister also received Hep-A #1 on the same date (same manufacturer and lot #) without noted adverse event. The plan is to re-admit child to hospital under Neuro-Science Institute for 3-5 days for observation. Mom reporting that frequency of episodes "about the same". Y N 10/20/2000 10/27/2000 7 Neurological exam-WNL Update information from 12/26/00; EEG and video of child during "episode" sent on 1/9/01. OTH PUB NONE NONE NONE AK200103 1
0164640 01/10/2001 GA 0.5 0 .5 F 12/15/2000 Redness and slight swelling of the right thigh. Y 12/11/2000 12/14/2000 3 PVT PUB Ear infection GA00147 1
0164641 01/10/2001 NM 46.0 46 M 12/19/2000 Swelling to wrist, down to hand and unable to make a fist. No redness or fever. Referred to PMD. Itching at injection site. U 12/18/2000 12/19/2000 1 PUB PUB NONE NM120003 1
0164642 01/11/2001 AZ 0.3 0 .4 F 01/04/2001 Within 48 hours post vax, the pt was found not breathing and had no heart rate. Following the vaccination she had been very tired and missed some feedings. When she was found not breathing, she was rushed to the hospital and within an hour of being found they were able to get a heart rate with resuscitation efforts. She remained intubated in the hospital but was brain dead and died on 10/21/00. Autopsy states cause of death as pneumonia. Y 10/21/2000 Y Y 2 N 10/18/2000 10/20/2000 2 Autopsy report-haven't received yet PVT OTH Milicon drops 1
0164646 01/11/2001 GA 25.0 23 F 11/27/2000 The pt experienced abdominal pain, nausea, vomiting, and diarrhea. Treated with pepto bismol. 60 day follow-up states the pt also experienced pradnial pain, diagnosed with gastroparesis, neuropsychological problems, auditorial deficits, memory loss, concentration loss, nausea, loss of fine motor skills, loss of complex visual memory, back pain, headaches, candida esophagus, ammenorrhea, decreased immune system, and multiple illeus's. Y N 01/14/1999 01/14/1999 0 NONE MIL MIL Birth control NONE NONE 1
0164647 01/11/2001 GA 25.0 23 F 11/27/2000 Post prandial abdominal pain, nausea, vomiting, diarrhea, chronic fatigue, recurrent blepharitis, joint pain, candida esophagitis, memory loss, lack of concentration, weight loss and headaches. Treatment: 1/00-prednisone but reflaring during taper, not responding well to 2nd trial in 5/00; 9/00-sulfasalazine with some improvement of GI pain but side effects of migraine type headaches and nausea; also tried Asacol and continues but has flares. Too many to list. Y N 05/18/1999 05/18/1999 0 All testing and data contained in pt/soldier's medical records. MIL MIL Birth control and Pepto-Bismol gastrointestinal complication NONE GI problems~Anthrax (no brand name)~2~24.00~In Patient 1
0164648 01/11/2001 TX 0.3 U 01/08/2001 "A company representative reported that a 4 month old received vaccines on 8/23/00. That evening, the infant developed a seizure. Seizures are considered "Medically Important". U 08/23/2000 08/23/2000 0 UNK OTH OTH UNK UNK U2001000280 1
0164649 01/11/2001 TX 0.2 U 01/08/2001 "A company representative reported that a 2 month old received vaccines on 6/24/00. On 8/13/00, the infant developed a seizure. Seizures are considered "Medically Important". U 06/24/2000 08/13/2000 50 UNK PVT PVT UNK UNK U2001000290 1
0164652 01/11/2001 LA 0.2 M 01/08/2001 10 days post vax, the infant developed a cough, fevers, and irritability. The infant was seen by a physician, and a chest x-ray was performed. The x-ray revealed an enlarged heart which had been normal size at birth. A diagnosis of cardiomyopathy was made, and the infant was hospitalized at at tertiary car center to undergo heart transplantation. Y Y U chest x-ray - enlarged heart OTH OTH UNK UNK U2001000300 1
0164653 01/11/2001 NC 38.0 M 01/08/2001 The pt complained of flu like symptoms and epigastric burning. He was treated with ranitidine. His symptoms worsened and he developed shortness of breath. He was hospitalized in intensive care at a tertiary care center on 8/2/00 with a diagnosis of dilated cardiomyopathy. He required balloon pump support and will require a heart transplant. Y Y U 07/06/2000 07/06/2000 0 UNK MIL MIL UNK UNK U2001000310 1
0164654 01/11/2001 FL 65.0 65 F 12/18/2000 The pt experienced extreme weakness to the point of nearly passing out, nausea and dizziness. Diagnosed with visual disturbance and increased blood sugar Y 3 N 11/15/2000 11/17/2000 2 OTH PUB Coumadin, aspirin NONE L. occipital Lobe infarct,Meniere's DX, HTN, Mitral Valve Prolapse, Arthritis 1
0164655 01/11/2001 NY 38.0 38 F 01/09/2001 A physician reported that a 36 year old female received an injection of Flu Shield '00-'01 formula in December, 2000. Approx. 8 days, post vax, the pt developed cranial nerve neuropathy. She was hospitalized. Follow-up information received from the physician on 2/20/01, indicated that this 38 year old female underwent a lumbar puncture. Results showed an increased protein level, normal glucose and 250 white blood cells. A subsequent LP showed a decrease in protein level. Unspecified testing was negative for toxoplasmosis, meningitis, tuberculosis, cytomegalovirus, Lyme disease, herpex simplex virus, Epstein-Barre virus, cryptococcosis and diabetes. A CD4/CD8 ratio was low. The physician reported that the pt is being treated for HIV. Follow-up information received on 4/23/01 via telephone message from the reporting physician, indicated that the pt is not "out of contact". Results of other tests indicate that the cause of her 3rd nerve palsy is not related to the flu vaccine. Y 14 U 12/01/2000 12/09/2000 8 LP X 2-abn; Unspecified testing-neg; CD4/CD8 ration-low; HIV-pending OTH OTH UNK UNK UNK HQ5588305JAN2001 1
0164656 01/11/2001 CA M 01/09/2001 A nurse reported that a pt received tetanus toxoid approx. 15 years ago and subsequently, experienced chest pain, "lock jaw" and neck swelling. The pt was hospitalized; he recovered. As of 11/21/00, no further information was available. Y Y UNK OTH OTH UNK UNK Chronic obstructive airways disease; cigarette smoker HQ4152828NOV2000 1
0164657 01/11/2001 PA 1.08 1 .1 M 01/09/2001 A nurse reported that a 13 month old male received Prevnar and MMR II vaccines on 12/1/00 and within 2-3 days, post vax, he developed a high fever, wheezing, blue lips, and shallow breathing. He had trouble breathing and was taken to the ER. He recovered. Dyspnea is considered "Medically Important". Y Y Y 12/01/2000 UNK PVT PVT NONE NONE UNK HQ5170221DEC2000 1
0164658 01/11/2001 PA 75.0 75 M 01/03/2001 Guillain-Barre Syndrome, weakness in legs, fall at home. Per F/U 3/23/01: The final dx was Gullain-Barre Syndrome which was made by a Neurologist. Within 4 weeks prior to the dx, the pt had cold symptoms. Per F/U 4/3/01: Pt is able to get up with moderate assistance. Gait is quite ataxic. In therapy, the pt made excellent progress. By the time of discharge, he was ambulating several hundred feet independently with a walker. Medications at discharge: Flomax 0.4mg po daily; multi-vitamins 1 po daily; Furosemide 20mg po daily; Coumadin 2mg po daily; Lanoxin 0.25mg po daily, Clorazepate 3/75mg po tid prn. The pt had received a routine flu injection and seemed to have no difficulty. About a week later, he developed upper respiratory tract infection symptoms. One or 2 weeks later, he developed some difficulty walking and weakness in the legs and ataxia and sensory dysfunction. Y 10 Y Y 12/01/2000 12/09/2000 8 Spinal Tap; CT of head; Per F/U 4/3/01: Coumadin therapy and INR's were therapeutic at 2.52 and 2.80, hemoglobin-14.2; hematocrit-42.4. PVT PVT allergy to PCN; hx of CHF, Atrial Fibrilation, BPH, mitral valve replacement 5/98; Per F/U 4/3/01: Positive history of anxiety and prostatism; pilonida cyst removed; tonsillectomy and milignant melanoma removed from face and neck without recurrence. He also has an allergy to aspirin. 1
0164659 01/11/2001 IA 0.3 0 .2 M 01/03/2001 Lethargy, low-grade fever the day of vaccines. The next day, had 3 hours of (less than 24 hours) inconsolable crying and low-grade fever then infant was ok. Y 11/02/2000 11/02/2000 0 NONE PVT PVT Tylenol NONE NONE 1
0164660 01/11/2001 PA 0.3 0 .3 F 12/22/2000 Elevated temperature (maximum 104F) through 12/17/00. Y Y 12/12/2000 12/13/2000 1 CBC PVT PVT NONE NONE 1
0164661 01/11/2001 NM 1.0 1 .0 F 01/02/2001 Measles-type rash with fever. Y U 12/22/2000 12/31/2000 9 PVT PUB NONE NONE NONE 1
0164662 01/11/2001 MD F 01/04/2001 Pain at site, then rest of arm. Seen by PMP within 48 hours. Presently in treatment with ice, electrical stimulation ROM; under treatment. Y U 11/21/2000 11/21/2000 0 OTH OTH Crohn's disease Crohn's disease 1
0164663 01/11/2001 CA 40.0 40 F 12/27/2000 Sick flu-like symptoms X 10 days (began on skin with fine rash off and on with hot, itchy skin X 10 day and some nausea and vomiting). History of having just started a new Estrogen replacement on 12/1/00. Referred to PMD for evaluation with regards to new HRT. U 12/14/2000 12/24/2000 10 NONE PUB PVT Hormone replacement therapy NONE Premature menopause with HRT since 1995. 1
0164664 01/11/2001 PA 79.0 79 F 01/04/2001 I became very weak and had difficulty breathing. The feeling lasted for several hours. Later in the evening, I had heart palpitations. Y 11/08/2000 11/08/2000 0 PUB UNK 1
0164665 01/11/2001 OH F 01/04/2001 10 days, post vax of flu vaccine, employee had enlarged lymph nodes in armpit (L) and left side of neck swollen. Swelling did not subside until 11/22/00. Y 11/07/2000 11/17/2000 10 UNK UNK Levoxyl; Claritin-D History of hypothyroidism 1
0164666 01/11/2001 NY 1.8 1 .0 M 01/03/2001 Herpes Zoster (Shingles) right arm. No recent exposure. Recovery is unknown at this time. U 03/20/2000 12/27/2000 282 PVT PVT NONE WAES01011340 1
0164667 01/11/2001 PA 33.0 33 F 12/26/2000 Red, swollen and warm to touch. U 12/19/2000 UNK UNK 1
0164668 01/11/2001 TX 42.0 41 F 12/06/2000 Pt presented to clinic with an insect sting and thinks she is allergic to stings and was given TD. Pt returned to clinic, 3 days later, with swelling, induration and itching at site of injection. Y 05/26/2000 UNK UNK Pt has hypertension, history of allergies 1
0164669 01/11/2001 ME 1.5 1 .7 F 12/29/2000 Pt developed redness in the area of injection with a hard nodule underneath area where shot was given. U 12/26/2000 12/27/2000 1 NONE PVT PUB NONE Otitis Media NONE 1
0164670 01/11/2001 CA 0.3 0 .3 M 12/20/2000 Onset of blotchy non-raised erythema, approx. 30 minutes, post vax. Pt referred to physician for possible treatment. No treatment required. Rash resolved within the hour. Y Y 12/20/2000 12/20/2000 0 PVT PVT NONE 1
0164671 01/11/2001 DC 2.0 1 .0 F 01/08/2001 Severe case of zoster involving entire right arm and hand. Referred to Dermatologist for dx. Prescribed Zovirax, orally. Y Y 05/07/1999 12/18/2000 591 PVT PVT NONE NONE NONE 1
0164672 01/11/2001 NY 2.0 2 .1 F 01/03/2001 Varicella rash, generalized, approx. 30 lesions developed on 12/30/00. U 12/26/2000 12/30/2000 4 PVT PUB NONE NONE 1
0164673 01/11/2001 MA 11.0 11 M 01/03/2001 Left deltoid at site of TD injection, was reddened, slightly swollen and had a 8" diameter around the site. Pt went to ER the following day (weekend), was treated with "something" to reduce swelling (according to mother). Y Y 12/15/2000 12/16/2000 1 PUB PUB NONE NONE NONE 1
0164674 01/11/2001 PA 7.0 2 .5 M 12/28/2000 Varivax received on 5/31/96. On 12/28/00, exposed to varicella. Had a mild case of varicella with about 10-12 pox. Still continues with rash. U 05/31/1996 12/26/2000 1670 NONE PVT PVT NONE Sinusitis on 5/31/96 NONE 1
0164675 01/11/2001 OH 1.2 1 .2 M 01/04/2001 Vaccine given on 12/18/00. Pt fell down stairs on 12/20/00. No LOC. Went to ER with closed head injury, acute facial laceration. On 12/23/00, vomited X 2. On 12/24/00, focal seizure. Y Y 12/18/2000 12/24/2000 6 CT of head-Neg PVT PVT NONE NONE 1
0164676 01/11/2001 NJ 52.0 52 F 01/06/2001 Right arm lump; size of baseball. U 12/27/2000 12/27/2000 0 PVT PVT 1
0164677 01/11/2001 TN 1.25 1 .3 M 12/27/2000 Right deltoid area became red, hot and swollen with a 7cm diameter area of erythematous induration. Child also developed red cheeks, vomiting and diarrhea. Pt was given Benadryl. Y 12/19/2000 12/20/2000 1 NONE PVT OTH Benadryl NONE NONE 1
0164678 01/11/2001 MI 0.8 0 .8 M 12/29/2000 Seen in morning, mild cough, history of wheezing, but lungs clear. Given Prevnar vaccine. In the afternoon, pt had sudden onset of grunting respirations and wheezing. Breathing improved with albuterol nebulizer treatment X 2. Y Y 12/28/2000 12/28/2000 0 CXR-neg PVT PVT NONE URI Mild wheezing, 2 weeks prior. 1
0164679 01/11/2001 CA 38.0 38 F 01/03/2001 The pt complained of both arms hurting, joint, muscle and bone pain. Can't lift heavy stuff. Finger joints also hurt. N 11/28/2000 12/05/2000 7 Refer to neurologist for further evaluation PVT PVT NONE NONE NONE 1
0164680 01/11/2001 CA 1.5 1 .5 F 01/08/2001 Febrile seizure, temperature 105F. Seen at CHLA. Y Y 12/29/2000 12/30/2000 1 PVT PVT NONE NONE 1
0164681 01/11/2001 CA 0.3 0 .3 F 12/29/2000 Mom reports, that night, post vax, she held her breath, turned pale, eyes went back and she became limp. She was still awake and looking around though. We were able to get her attention. The event lasted 1-2 minutes and she became normal again. She thinks child had similar episode after about 2 weeks, but didn't call for a week later and spoke with a doctor about it on 12/28/00, this time. Y 12/18/2000 12/18/2000 0 NONE PVT PVT NONE Mild URI/diaper rash NONE (Has a twin brother) 1
0164682 01/11/2001 PA 6.0 1 .0 F 01/03/2001 Pt developed chickenpox on 12/28/2000 and was seen by a doctor on 1/3/01. Y 06/05/1995 12/28/2000 2033 NONE PVT OTH NONE NONE 1
0164683 01/11/2001 ID 13.0 13 F On 12/29/00, that night, post vax, pt developed redness on face, worse the next AM but getting better. It also itched and he had mild URI symptoms. No SOB. Y U 12/29/2000 12/29/2000 0 MIL MIL NONE Redness and itching on face NONE 1
0164684 01/11/2001 FL 17.0 17 F 01/05/2001 Pt's reaction occurred, that PM at approx. 18:00. She had red face, was hot and had itching. Pt very agitated. On 12/18/00, spoke to mother. Rash had spread from her face to her neck, lasting 2 days. Mother gave Benadryl. No respiratory effects. Y 12/07/2000 12/07/2000 0 PVT PVT NONE NONE 1
0164685 01/11/2001 FL 1.25 1 .3 F 12/29/2000 URI, congestion, cough and low-grade fever; no rash. Y 12/21/2000 12/29/2000 8 NONE PVT PVT Tylenol 1
0164686 01/11/2001 MD 35.0 35 F 01/04/2001 On 12/24/00, had hives, itching on entire body, fever of 101F and swelling of arm. Took Benadryl. On 12/31/00, Hives were less, had a slight fever, swelling of arm was less that 1/2 dollar-sized. Took Benadryl. Y 12/24/2000 12/24/2000 0 NONE PUB PUB NONE NONE NONE 1
0164687 01/11/2001 IN 1.08 1 .1 F 01/04/2000 Pt developed 3-4 lesions at the site of injection and some fever. Y 10/18/2000 11/01/2000 14 PUB PUB NONE NONE NONE 1
0164688 01/11/2001 MN 31.0 30 F 10/11/2000 Vaccine given on 9/27/00 and reported to EH on 10/2/00, that starting, 1 day post vax, the area around the injection site became firm to touch, swollen, reddened and painful. Symptoms still persist. Pt had some kind of accident at work to her right upper arm. Y 09/27/2000 09/28/2000 1 NONE PVT UNK Claritin NONE NONE 1
0164689 01/11/2001 MN 25.0 25 F 10/11/2000 Vaccine given on 9/27/00. Reported to employee health nurse on 10/2/00. Had a large, area around injection site of firm, swollen, painful to touch and reddened. Pt had some kind of accident at work to right arm. Y 09/27/2000 09/28/2000 1 NONE PVT UNK Norvasc, Zyrtec NONE NONE 1
0164690 01/11/2001 PA 70.0 70 F 12/22/2000 Developed immediate local reaction to shot. Treated initially with ice and then warm soaks. Returned on 10/19/00, complaining of pain, swelling and redness and on 10/26/00 and 12/5/00. Treated with Keflex X 7 days on final onset with relief. Still with redness, heat and swelling and pain. Y U 10/16/2000 10/16/2000 0 UNK UNK UNK HTN; CAD; MV regurgitation 1
0164692 01/12/2001 NY 52.0 52 F On 11/14/00, this 52 year old female received a Fluvirin vaccination at her local drugstore. "A few days later", she developed bilateral soreness/weakness of her shoulders. She also noted a rash on her right hand and on bony prominences; "knuckles, ankles and elbows". The dx of "dermatomyositis" has been made. Pt states that "dermatomyositis is sometimes involved with cancer", but that her tests have all been negative for malignancy. Additional information has been requested. The follow up received on 3/22/01 states "dermatomyositis, muscle weakness, muscle soreness, and rash (November 2000)." U 11/14/2000 Blood tests revealed elevated CPK and aldolase. A muscle biopsy was positive for myositis. OTH PVT NONE NONE MPI2001000080 1
0164693 01/12/2001 OH 1.0 1 .0 F 01/10/2001 Pt had seizure (febrile) on 11/20/00. Photograph also shows red, macular rash over face and body. Y Y 11/08/2000 11/20/2000 12 PVT UNK NONE NONE ~Measles + Mumps + Rubella (MMR II)~~11.00~In Sibling 1
0164694 01/12/2001 CA 1.08 1 .1 M 01/05/2001 Rash starting on right axilla and spreading to chest, abdomen, back and a few on lower right upper extremities. It was maculo-papular, bright red and erythemic lesions. U 12/20/2000 12/29/2000 9 PVT PVT NONE 1
0164695 01/12/2001 IA 1.0 1 .0 F 10/02/2000 Mother noted symptoms of fever of 100F, runny nose, "difficulty breathing", incoordinated walking. Symptoms for 2-3 days. No ER or MD visit or evaluation. Y 09/22/2000 09/24/2000 2 NONE PVT PVT NONE NONE NONE 1
0164696 01/12/2001 CA 73.0 73 M 12/27/2000 The nurse who gave me the shots in the line I was in, gave me 2 shots and when I asked her why she gave me 2 shots, she mumble something that I could not understand. By 20:00, that same day, my body was covered with hives from my neck to my feet. My genitals, legs, ankles and feet were all very swollen. There was no itching, but I felt "unwell" and uncomfortable and very frightened, to say the least. I have been getting the flu shots every year for the past 10 years and have never had an allergic reaction before. On 11/17/00, I called the clinic and explained what had happened and she said I must have received a pneumonia shoe, as well, however, I did not sign the form for a pneumonia shot, I did not pay the extra $2.00 for a pneumonia shot and I was not in line for the pneumonia shot. My physician prescribed Benadryl, which did not help. My body was so puffed up that I gained 15 pounds in 3 days. I was then prescribed Prednisone, which seemed to help and my body weight gradually returned to normal and the hives are slowly fading. However, as of this date, 4 weeks, post vax, of the 2 flu shots, my ankles and feet are still swollen and I still have red hives on my feet and I still do not feel well. I have gone to several different doctors and none have any definitive answers as to how long this is going to last and what I can do about it. I am getting desperate. Is there someone in your organization who can help me? Y U 11/15/2000 11/15/2000 0 OTH OTH 1
0164697 01/12/2001 CA 46.0 46 F 01/10/2001 Soreness at site of injection. "Nerve pinched". Began to feel sore 7 days, post vax, while she was in Europe. She called me on 1/8/01 to "report" not "complain", she said. She also felt that the injection was given too high on the arm. (She was an RN) Injection was given in the upper deltoid region and still has "intermittent pain". U 12/04/2000 12/11/2000 7 OTH PVT NONE NONE 1
0164698 01/12/2001 OK 49.0 49 F 01/04/2001 Petechia appeared from knees down (bilateral) and persist to date, starting the day after vaccination. U 12/01/2000 12/02/2000 1 PVT PVT Levoxyl, Prempro NONE Hypothyroidism; replaced 1
0164699 01/12/2001 MT 51.0 51 F 11/29/2000 Left arm bruised and became swollen within 1 1/2" of elbow; red, hot and sore. Pt experienced headache and chilling that evening. She visited her physician the next day and he felt it to be an allergic reaction to the flu shot and to never get another one. Treated symptoms with Motrin, fluids and rest. Y Y 11/08/2000 11/08/2000 0 NONE PUB PUB Premarin, Synthroid NONE Allergy to TD shot, iodine, bees, smoke, animals and grass. Unspecified reaction~Tetanus Toxoid (no brand name)~~44.00~In Patient MT0104 1
0164700 01/12/2001 NY 49.0 49 F 01/04/2001 Went to clinic at 17:00 on 12/30/00 with arm swollen and red, 4" below shot site, in left arm. Developed shortness of breath and swollen throat. Treated with 1 shot of Prednisone and po X 6 days and Benadryl X 2 days. Y Y 12/29/2000 12/29/2000 0 PUB PUB Claritin, Atrovent inhaler NONE Airborne allergies, household cleaners and perfumes. 1
0164701 01/12/2001 MT 87.0 87 M 12/13/2000 3 days, post vax, pt started to have "tingling in both hands and feet and felt itchy all over and this lasted almost a week". Now, 1 week later, it "feels better but still have a little itching/tingling in hands/feet". Y 11/17/2000 11/20/2000 3 PUB PUB Lanoxin, prednisone, Lasix, Atarax, Accupril, Coumadin, Procardia, Proscar, Imdur, Actos Atrial fibrillation, COPD, DM Type II, CAD, Arthritis MT0103 1
0164702 01/12/2001 ME 5.0 5 M 01/09/2001 Febrile seizure, within 24 hours, post vax. Occurred on 1/5/01. Of note: pt's sister was ill at the time with viral gastroenteritis. Y Y 01/04/2001 01/05/2001 1 PVT PUB NONE NONE Allergy to PCN 1
0164703 01/12/2001 OH 68.0 68 M 01/10/2001 Swelling from injection site to elbow; 12" of swelling, pain and tenderness, hot to touch. Y U 12/27/2000 12/27/2000 0 Physician's assessment PVT PVT NONE History of Achalasia of the esophagus-surgery in 1971 1
0164704 01/12/2001 NC 4.0 4 M 08/20/2000 Mother reports temperature of 103F, lethargy and significant local reaction of right arm. Y Y 07/27/2000 07/28/2000 1 PUB PUB NONE Cerumen impaction Heart murmur, fine motor delay Fever~DTP (no brand name)~3~1.50~In Patient NC00001 1
0164705 01/12/2001 MT 5.0 5 M 01/04/2001 Telephone call with mom, reports massive swelling, warm in left arm, post vax, Called ER X 3; gave child ibuprofen as directed, to decrease swelling. He developed fever of 101F while taking ibuprofen. Swelling extended from below elbow to collar bone/arm pit area. Resolved by 1/2/01. Not seen by a MD. Y 12/29/2000 12/30/2000 1 NONE PUB PUB NONE Recovering from URI and ear infection NONE Leg warmth~DTaP (no brand name)~2~4.00~In Patient MT0101 1
0164706 01/12/2001 AZ 0.2 0 .2 M 01/04/2001 Vomiting, prolonged crying (>5 hours), hypotonic, hyporesponsive episode for about 3 minutes. Y Y 12/18/2000 12/19/2000 1 NONE MIL MIL NONE NONE 1
0164707 01/12/2001 NV 23.0 23 F 12/29/2000 At 12:35, pt began to feel faint, post vax. At 12:36, pt complained of hot flashes with numbness in left arm and shortness of breath. At 12:37, pt put on O2 at 10LPM via non-rebreather and put on monitor X 1 hour. Pt's vital signs at onset were BP-110/71, P-66, R-16 and temperature was 96.5F. Pt had a vasovagal reaction to injection. Y Y 12/29/2000 12/29/2000 0 MIL MIL OCP's NONE Allergy to clindamycin 1
0164709 01/12/2001 WY 0.9 0 .9 M 09/06/2000 Within 1/2 hour, post vax, pt developed crying and was unable to console. Pt was seen by MD and he felt reaction was to vaccine. Physical exam was not performed per mother. Tylenol with codeine was Rx'd and mother was told to watch for respiratory distress. Y 09/06/2000 09/06/2000 0 NONE PUB PUB NONE NONE Hayfever Crying; unable to console~DTaP (no brand name)~1~0.25~In Patient 1
0164710 01/12/2001 IL 1.0 1 .0 M 04/09/2000 Diarrhea, vomiting. Treated with IV-D5 norm. M, Tylenol, lab work with 23 hours of hospitalization. Y 1 Y 05/02/2000 05/07/2000 5 CBC with differential; metabolic panel-bicarb 14, creatinine .2 PVT PVT NONE NONE NONE 1
0164711 01/12/2001 MO 35.0 35 F 08/25/2000 On 8/23/00, arm sore, erythematous with swelling, tingling noted in hand. No temperature elevation. Itching all over. Seen in ER and instructed to alternate hot and cold packs. Given Benadryl, ibuprofen and Tylenol #3 Rx's. Y U 08/21/2000 08/23/2000 2 NONE PUB PUB PPD received on same day and showed no reaction. NONE NONE MO200062 1
0164712 01/16/2001 MT 0.3 0 .3 M 12/15/2000 None reported to this office. Autopsy states cause of death as sudden infant death syndrome. Y 11/11/2000 N 11/10/2000 11/11/2000 1 PVT PUB NONE NONE NONE MT0102 1
0164713 01/16/2001 MA 1.25 1 .3 F 01/08/2001 On 1/8/01, the physician received a phone call stating that the pt died on 1/6/01 in the A.M. Y 01/06/2001 N 01/05/2001 01/06/2001 1 PVT UNK Poliovax by Connaught, Lot #R0692 given SC Constipation Cerebral dysgenesis, congenital CMV, developmental delay 1
0164714 01/16/2001 MD 25.0 F 01/09/2001 It was reported that the pt's last menstrual period was 2 weeks prior to vaccination. In October 2000, the pt informed her physician that she had a miscarriage. No further information is available. N 09/01/2000 10/01/2000 30 OTH OTH UNK Pregnancy (LMP-09/01/2000) WAES00122066 1
0164715 01/16/2001 AZ 0.25 0 .2 F 10/24/2000 On 10/23/00 at 17:15, doctor received a phone call from ER stating baby brought in. Found in bed, already had some rigor/cyanosis; coded but pronounced dead. Autopsy states the cause of death as interstitial pneumonitis. Also states baby girl was found unresponsive in her play pen, lung congestion Y 10/23/2000 N 10/19/2000 10/23/2000 4 PVT PVT NONE Baby was a twin. 1
0164716 01/16/2001 CA 76.0 76 U Dizziness, ache, weakness, hands swelling, feels sandy, fingers locking on right hand, runny nose, allergic to flu shot. Y Y U 11/25/2000 11/26/2000 1 MIL OTH 1
0164719 01/16/2001 PA 70.0 70 F 01/08/2001 Information has been received from a NP concerning a 70 year old white female who on 10/16/00 was vaccinated with the 1st dose of pneumococcal vaccine 23 polyvalent in the right deltoid. On 10/19/00, the pt developed red, hot, painful, swollen right arm. After 2 months, the pt was still experiencing her symptoms. The pt sought medical attention at the doctor's office. The NP considered the pt's experience to be an "Other Medical Event". At the time of the report, the pt's final outcome was unknown. No additional information is expected. Y U 10/16/2000 10/19/2000 3 PVT PVT Lotensin, Alphagan, Prevacid, Xalatan, Synthroid glaucoma, hypertension, ragweed allergy WAES00120398 1
0164721 01/16/2001 ME 78.0 78 F 01/03/2001 Complaining of shortness of breath; laid back on table and became blue (cyanotic) around mouth and stopped breathing; CPR administered and Epi-pen injected; immediate response. Given epinephrine. Episode lasted approx. 4 minutes, no further incidence. Y Y Y 12/11/2000 12/11/2000 0 NONE PVT PUB Atrovent, Zoloft NONE Emphysema ME01002 1
0164722 01/16/2001 WA 7.0 7 M 10/01/2000 Approx. 2-3 weeks following the 5/12/98 MMR IZ, fine tremors were noted in both hands, lasting for brief periods (less than 30 seconds). Over the next few months the hand tremors become more noticeable lasting for longer periods of time, eventually becoming constant. By November, 5 months after the immunization, episodes of leg weakness developed resulting in slow ambulation and unexplained falling to the ground. By January, 7 months after the IZ, severe leg weakness developed manifested by ataxic gait and total body collapse with inability to get off the floor. Through out the year, his condition continued to rapidly deteriorate, resulting in the loss of function in both hands, both legs, voice, and oral muscle control resulting in excessive drooling. Approx. 15 months, post vax, he was wheel chair dependent, required total assistance with feeding, toileting, and mobility. Currently his level of function continues to decline with no reversal or improvement in symptoms. Although, he has had extensive and extremely thorough medical evaluations by numerous physicians to determine the cause for this progressive demise in health and function, no medical dx has been made. Y Y N 05/12/1998 PVT PVT NONE NONE allergy to Ceclor 1
0164724 01/16/2001 VA 1.2 1 .3 F 01/08/2001 The infant had a temperature of 103.2 for two nights, 101.3 on 01/05/01. Y 01/03/2001 01/03/2001 0 PVT PVT NONE 1
0164725 01/16/2001 CA 0.2 0 .2 F 01/05/2001 The infant had immediate pallor (less than 3 minutes), decreased muscle tone and listless, no loss of consciousness. No treatment, gradual improvement over 10-15 minutes. Y 01/05/2001 01/05/2001 0 NONE PVT PVT IPV, Prevnar, Comvax NONE NONE 1
0164726 01/16/2001 ME 1.5 1 .5 F 01/05/2001 The patient had a fever of 105 (rectal), the morning of the vaccination. Y 12/28/2000 12/29/2000 1 PVT UNK NONE NONE 1
0164727 01/16/2001 VA 22.0 F 11/02/2000 In the first two months of 1999, I received my first three Anthrax shots. On May 30, 1999 I went to the medical facility complaining of blisters that appeared on the skin in various spots and turned into itchy, dry patches of the skin. The problem had been going on for about a month when I went to medical. They gave me Benadryl for the itching and a topical cream for the patches of dry sky. On June 22, 1999, I was back in medical because the condition had worsened; they were guessing that it might be Eczema. Due to the fact that we were on our six month cruise, medical did not have the facilities or the expertise to diagnose me or care for me. I was told that I would need to wait till I could see a dermatologist. They gave me Keri lotion and some topical creams told hold me over. On July 29, 1999, I received my fourth Anthrax shot. My skin never healed during this period of time. On September 20, 1999, six days before we were due back, I again ended up in medical. My skin was so bad that I could not stand it. I would scratch so bad I would bleed through my uniforms. Medical again gave me Benadryl for the itching and some moisturizers. I was then given a referral to Hospital. I saw a dermatologist on October 20, 1999. She put me on Prednisone, which had helped while I was on the medication however when I stopped taking the medication I had a severe break out. I then received Temovate, a topical steroid, moisturizer, and medicine for the itching. The dry patches of skin were now covering 50 percent of my body. From my scalp all the way down my legs. The medications unfortunately did not help. I saw a dermatologist that had recently taken over for the first dermatologist I saw, She took over November 16, 1999. She gave me new moisturizer, more Temovate, and Atarax for the itching. I was then started on the light box treatment, which was the highest medical protocol treatment available. That had little effect on my skin. The dermatologist diagnosed nummular eczema. I had a follow up appointment with the dermatologist on November 30, 1999. Since there was no real improvements in my skin she ordered a patch test, which is an allergy test. The skin on my back was so bad that they could not do the test right away, it was delayed until the week of January 3, 2000. When the results came back I was slightly allergic to Formaldehyde and Quaternium 15. Formaldehyde is the Anthrax shot along with many other vaccines. I was not to take any more vaccines containing Formaldehyde. I had another follow up appt with the dermatologist on January 24, 2000. The condition of my skin had deteriorated. The same medications were prescribed now the dermatologist wants to do a biopsy. On February 16, 2000 the biopsy was performed, results were all negative. I was again put on Prednisone. She saw me again on March 7, 2000. The Prednisone had worked slightly but when I went off of it my skin has a major flare up again. On March 14, 2000 I was put on Prednisone again. With the same results as the last time. Up until now there has been no improvements with my skin. Y N Patch test, Light box treatment, skin biopsy MIL MIL Prednisone, Benadryl, Topical steroids, Atarax NONE Allergy to Penicillin (no other) 1
0164728 01/16/2001 MN 1.3 1 .4 M 01/04/2001 The infant had a papular rash, pruritis on entire body, most pronounced on right thigh area (site of Prevnar). Treated itching with Zyrtec by mouth. U 01/02/2001 01/03/2001 1 NONE PVT UNK NONE NONE NONE 1
0164729 01/16/2001 VA 0.75 0 .8 M 01/05/2001 This 9 month old infant had a 2 1/2 by 3 1/4 cm erythematous circular area surrounding the injection site with a firm indurated area. The site was warm to touch, the reaction began 48 hours after the injection. The infant was started on Augmentin for cellulitis. Y 01/03/2001 01/04/2001 1 NONE PVT PVT Augmentin started 1/3/01 Bilateral Otitis Media History of Gastroesophageal Reflux and Pyloric Stenosis 1
0164730 01/16/2001 MA 3.0 2 1 M 01/06/2001 This child had a 5 by 5 cm area of erythema and induration plus 2 areas proximal of erythema. U 01/03/2001 01/04/2001 1 PVT PVT NONE NONE 1
0164731 01/16/2001 NY 62.0 61 F 01/02/2001 This patient had worsening of osteoarthritis, especially in the knees. The right knee swells, and decrease in range of motion. U 04/01/2000 06/01/2000 61 knee x-ray (revealed calcium deposits) PVT UNK 1
0164732 01/16/2001 MA 61.0 60 F 01/02/2001 This patient has severe joint pain (disabling), swollen Joints, severe headache, muscle pain, rib and chest soreness, fever (100), neck stiff and painful to move, poor balance, ache all over, flu like symptoms, generalized ill feeling, extreme fatigue. There were three episodes lasting 1 week to 10 days (06/29/00, 08/01/00, 11/23/00). Currently taking Tetracycline. Y Y N 05/15/2000 06/29/2000 45 Western Blot (07/12/2000) IGG bands Present: 41/31. IGM bands Present: 83/31. PUB PUB Premarin, Ritalin, Motrin 7/12/00 IGG results indicate undiagnosed pre-existing Lyme Infection at the time of the vaccination. I was never given a Lyme test prior to vaccination. Though I had come in with tick bites several times over a number of years. NONE 1
0164733 01/16/2001 MA 45.0 45 M 12/28/2000 On 11/20/2000 it was reported to Employee Health. The patient had a raised rash, tingling in hands. ?"Arthritis in the finger". The rash had gone and the patient states the arthritis in his fingers are improving. Y 11/06/2000 11/08/2000 2 PUB OTH NONE NONE NONE 1
0164734 01/16/2001 PA 34.0 34 F 01/09/2001 The patient states she had pain and burning at the site of injection, with a lump and redness over the next two weeks. The pain radiated down the wrist and up to the shoulder. The patient was given Naproxen by his PCP. U 10/10/2000 10/10/2000 0 OTH OTH 1993 history of left arm musculoskeletal problems 1
0164735 01/16/2001 NY F 11/16/2000 The patient received Aventis Influenza vaccine, and developed Bell's Palsy on the following day. The patient developed left facial droop one day after receiving the Influenza vaccine. She had also received Trastuzumab and Paclitaxel on the same day. An MRI and Lumbar Puncture were performed to rule of Leptomeningitis. Y U 11/15/2000 11/16/2000 1 MRI (negative), Lumbar Puncture (negative) UNK UNK Taxol, Herceptin Metastatic Breast Cancer 1
0164736 01/16/2001 MN 73.0 F 12/27/2000 The patient states 1st time was in the middle of the night around 1:30-2:00 AM. There was a rapid heartbeat, dizziness that lasted about 1/2 hour. The 2nd time was while driving, she had a rapid heartbeat, got very hot, and felt like she was going to pass out; that lasted about 15 minutes and started to subside. She does not take flu shots since then. Y PUB UNK Synthroid, Proventil inhaler, Hydrachlorathyazide NONE Asthma 1
0164737 01/16/2001 UT 74.0 74 M 01/06/2001 The patient states 45 minutes after eating bagel with egg and salsa he became very dizzy, unable to drive his car, and then threw up 4 times. He stayed in bed the rest of the day. He had symptoms of becoming dizzy for several days. Y 11/30/2000 12/05/2000 5 PUB OTH NONE 1
0164738 01/16/2001 NJ 64.0 64 F 01/05/2001 The patient has swelling, pain and red rash on upper right arm where the shots were administered. It lasted for 48 hours. The patient called the Co Bd of Health the next day and personal physician the day after. Missing vaccine information not available. Y 11/16/2000 11/17/2000 1 OTH OTH NONE 1
0164739 01/16/2001 MI 18.0 18 F 10/20/2000 The patient had a vaccine, about 6 hours after she began experiencing bruising, arm, elbow and wrist pain, left arm pit and side swelling. U 10/19/2000 10/19/2000 0 PVT UNK NONE Asthma 1
0164740 01/16/2001 MI 48.0 48 F 10/20/2000 The patient had pain and swelling under her right arm, extending along the right side of her ribs. There was redness under her arm and spotty redness on her upper arm, and a bruise at the injection site. U 10/18/2000 10/20/2000 2 PVT UNK Lexxel, Serevent, Prevacio None Asthma 1
0164741 01/16/2001 MD 63.0 63 F 01/06/2001 This patient had weakness, generalized achiness, temperature of 100, and flushed. U 01/03/2001 01/05/2001 2 PVT PUB Pravachol, Naproxen, Lotensin NONE Hypertension 1
0164742 01/16/2001 TX 10.0 10 F 01/05/2001 Approximately 10 minutes after this patient had a vaccine given, she had 30-60 second seizure. No history of seizure disorder. The patient had not eaten in a while also. Y 01/05/2001 01/05/2001 0 PVT PVT Claritan NONE Headaches 1
0164744 01/16/2001 MN 26.0 26 F 01/05/2001 This patient had an injection; 15 minutes after she complained of numbness, tingling feeling in her arm from elbow to fingertips. Then 30 minutes after the injection, the tingling feeling moved up into her shoulder area. Injection site not red or swollen, arm not swollen. The patient called the MD. The doctor stated to the patient to take Ibuprofen and put ice on it. TC to the patient at 2:30, she stated she was feeling better but her arm was sore and slightly swollen at the injection site. U 01/05/2001 01/05/2001 0 OTH UNK NONE NONE NONE 1
0164745 01/16/2001 CA 5.0 5 F 12/29/2000 This patient had a severe headache, fever to 104 and lethargy beginning approximately 24 hours to 36 hours after Typhoid immunization was administered. On exam, no other illnesses were obvious. Y U 12/27/2000 12/28/2000 1 Heart rate 110 / min. Temp 103. 9 oral. RR 20 / min. MIL UNK NONE NONE 1
0164746 01/16/2001 WA 1.2 1 .2 M 01/03/2001 This infant had a temperature of 105. Y 12/20/2000 PVT UNK NONE 1
0164747 01/16/2001 MD 45.0 45 F 01/05/2001 This patient got a Tetanus shot on 12/20/00, she developed a generalized hive like rash. Y Y 12/20/2000 12/21/2000 1 NONE PVT OTH NONE NONE Pepcid 1
0164748 01/16/2001 MI 3.0 1 .1 M 01/04/2001 This child received vaccination on 03/30/98 at the age of 12 1/2 months. Onset of varicella disease 01/04/01 and possibly father of child also. U 03/30/1998 01/05/2001 1012 NONE PVT PUB NONE NONE NONE 1
0164749 01/16/2001 OH 1.8 1 .9 M 12/28/2000 This patient developed chicken pox 12/00. U 08/05/1995 12/28/2000 1972 Clinical Diagnosis PVT PVT NONE NONE 1
0164750 01/16/2001 CO 40.0 40 M 01/09/2001 This patient had a varicella like rash. Y 12/20/2000 01/01/2001 12 10/25/00 varicella zoster titer - negative. PUB OTH UNK UNK Allergic to Penicillin 1
0164751 01/16/2001 CA 4.0 4 F 12/22/2000 On 12/21/00, this patient had a mild fever, rash to left upper deltoid, swelling, and redness. She was seen by a doctor on 12/22/00, and treated with Hydrocortisone cream. Return to clinic when necessary or sickness increases. Y 12/20/2000 12/21/2000 1 PUB PUB NONE NONE CA000156 1
0164752 01/16/2001 MI 70.0 70 F 10/23/2000 This patient had immunization, 24 hours after she had a small bruise at the site of injection, with redness, swelling, and some burning in the arm; pain radiates to elbow. The patient had patches of red swollen areas; symptoms lasted about 36 hours. Y 10/20/2000 10/21/2000 1 PVT PVT Lanoxin, Acupril, Synthroid, Eustace NONE Atrial fibrillation, hypertension, hypothyroidism. 1
0164755 01/16/2001 NY 51.0 51 F 10/19/2000 Following vaccination, the pt experienced a loss of taste and smell. As of 8/24/00 the symptoms persisted. Y N 10/25/1999 UNK PVT PVT vitamins NONE UNK HQ0550201SEP2000 1
0164756 01/16/2001 NY 46.0 M In the fall of 1999, the pt developed a "splitting" headache and an injection site reaction characterized by swelling, redness, hardness, and warmth. Later he developed malaise which lasted about 1 week followed by "mild" flu symptoms. Y UNK OTH OTH acetylsalicylic acid, lansoprazole UNK diabetes mellitus HQ1146118SEP2000 1
0164757 01/17/2001 MA 0.08 0 .1 M 01/08/2001 The pt died from SIDS less than 12 hours post vax. Y 12/19/2000 N 12/19/2000 12/19/2000 0 Post mortem exam revealed no specific cause of death. PVT PUB NONE NONE NONE 1
0164758 01/17/2001 LA 66.0 66 M 12/21/2000 The pt experienced a heart attach and died. The pt had a hx of heart problems in the past. Y 12/20/2000 N 12/19/2000 12/20/2000 1 UNK PUB PUB History of heart problems in the past. LA010101 1
0164763 01/17/2001 NY 0.2 0 .2 M 01/10/2001 The pt experienced an apneic episode within 24 hours of vaccine. Y Y Y 3 Y 01/05/2001 01/06/2001 1 PVT PVT Fer-In-Sol, Poly-Vi-Sol, Synagis Lot 907554 NONE 30 weeks' ex-premie with 7-8 day of mechanical ventilation. 1
0164764 01/17/2001 NC 60.0 60 F 01/04/2001 Pt presented to the clinic "feeling well" to receive her 2nd Hep-B vaccine. She had received her 1st dose on 8/15/00 without complications. About 10 minutes, post 2nd dose of vaccine, she felt hot, sweaty, dizzy and fainted. Then, she complained of chest pain and while lying down, appeared to have tonic-clonic generalized seizure, lasting 2-3 minutes. She was admitted for observation without recurrence. Y Y 2 Y 10/16/2000 10/16/2000 0 Throughout this event, BP, HR, O2 Sat remained stable. She had negative stress tests 6/97 and 9/00. PUB PVT Aldactone, Lasix, Actigall, Insulin, Zantac, Norvasc, Phenergan, albuterol NONE Allergies to Talwin, Percocet, iodine, PCN, codeine. History of cirrhosis (poss. liver transplant), DM, hypertension, seizure in 1980. 1
0164767 01/17/2001 AZ 37.0 37 F 06/10/2001 Pt notes onset of dizziness, orthostatic changes, memory loss and lethargy since beginning Anthrax series. This pt Anthrax #1 in 1/99 and shot #5 in 1/00. Since starting the series, she records decreased memory, itching and the appearance of sores in her ear canals, rash and dry skin at the shot site plus thighs, lethargy, vertigo, chest pain, joint pain, diarrhea and sudden clearing of her vision so that she no longer needs glasses. The chest pain occurs 1-2 X per week, lasting 5-10 seconds; sharp diaphragmatic pain and the intensity is incapacitating. She has continuous joint pain involving knees, elbows, ankles and hips often with numbness and weakness of forearm muscles. Sudden movements causes perception of the world spinning around; dx'd in 3/98 with benign positional vertigo treated with meclizine and pseudoephedrine with poor response. The impression is that most physiologic complaints are probably referable to pre-existing Hypothyroidism. There is the possibility that IZ stimulated an inflammatory response which increased pre-existing symptoms or activity of pre-existing disease. Continue IZ's as indicated is recommended. IZ's may cause flu-like symptoms, which may entail worsening of other pre-existing complaints. The follow-up received on 06/10/2001 states that the pt still has he itching at site of injection, dizziness, heart flutters, occasional loss of consciousness, memory loss, and vision correction. Y N 01/15/1999 01/28/1999 13 Visual tests; CT of abdomen and pelvis-WNL in 1/99 (done due to palpable 3cm mass LLQ); Vulva biopsy done 3/99-showed squamous hyperplasia; neurological exam; Electronystagmogram and brain MRI with contrast-both WNL. MIL MIL Synthroid Recurrent Vaginitis; Vulva condylomata; Mass LLQ; Squamous hyperplasia; Hypothyroidism; Fibrocystic disease with scattered calcifications on mammogram; Chronic rhinorrhea with allergies to grasses, trees, weeds, dust mites and cats; congenital hip dysplasia at age of 3 treated with braces for 6 months, dx'd in 6/89 as having patellofemoral syndrome with X-rays of knees and hips-NML 1
0164768 01/17/2001 PA 47.0 47 M 01/10/2001 A pharmacy student reported that a 47 year old male received an injection of Flu Shield ('00-'01) on 12/12/00. On 1/7/01, the pt was hospitalized with elevated phenytoin (33 mcg/mL) and phenobarbital levels (no value provided). Y U 12/12/2000 01/07/2001 26 Drug level NOS above therapeutic level Phenytoin (Dilantin) and Phenobarbital levels. OTH OTH Dilantin, Phenobarbital UNK UNK HQ5758910JAN2001 1
0164769 01/17/2001 IN 51.0 51 F 01/09/2001 Pt received flu shot. Next morning area red and sore. Tolerated it for 1 day and then began feeling fluid move about in the shot area. Knot became grapefruit-sized so went to MD and he placed her on Keflex. Arm continued to feel worse and had aches all over body. Temperature was 100F-101F. Was advised by MD to go to ER. Admitted to the hospital for 2 days for IV antibiotics. Could not return to work until 1/4/01. Y Y Y 12/23/2000 12/24/2000 1 X-rays and lab work which showed WBC-elevated; cellulitis OTH PUB UNK Cellulitis UNK 1
0164770 01/17/2001 MI 4.0 4 F 01/12/2001 A mother reported that her 4 year old daughter received DTP, HIB and oral Poliomyelitis virus vaccines on 3/31/91. She subsequently, developed an URI and was treated by a physician. She "eventually" recovered. Y Y 03/31/1991 UNK OTH OTH UNK UNK UNK URI~Td Adsorbed (no brand name)~~0.00~In Patient HQ5338328DEC2000 1
0164771 01/17/2001 CA 2.0 2 .3 F 12/20/2000 The pt experienced a 1 1/2 - 2 inch area of redness with swelling and an area of hardness at the site of injection. U 12/18/2000 12/18/2000 0 PVT PUB NONE 1
0164772 01/17/2001 NY 0.2 0 .2 M 01/07/2001 The pt developed a macular-papular rash over his head and body beginning 1 day post vax. The pt was prescribed calamine lotion and Atarax. No hx of fever or URI. Symptoms point to rash development. Y 01/02/2001 01/03/2001 1 NONE PUB PUB NONE NONE 1
0164773 01/17/2001 ID 2.0 1 1 M 11/24/2000 1 week post vax, the child developed a fever then apthous ulcers in his mouth. U 11/17/2000 11/24/2000 7 PVT PUB NONE NONE NONE ID00055 1
0164774 01/17/2001 NY 0.3 0 .3 F 11/15/2000 The pt experienced a fever of greater than 103 and periods of screaming at night. The fever began a few hours post vax. Y 11/13/2000 11/13/2000 0 PVT UNK 1
0164775 01/17/2001 OH 0.3 0 .4 F 01/12/2001 The pt experienced persistent crying for more than 3 hours which began within 24 hours of vax. The pt was evaluated at the hospital. It was thought to be related to the DTaP vaccine. Y Y 01/10/2001 01/11/2001 1 PUB UNK NONE NONE NONE 1
0164776 01/17/2001 FL 1.0 1 .0 F 01/11/2001 The patient woke this morning with red bumps on her cheeks, arms, back and stomach. Around 1pm the rash got much worse so the patient was brought into the office. The patient was treated with Atarax and Tylenol. Y U 01/04/2001 01/11/2001 7 NONE PVT PVT NONE NONE 1
0164777 01/17/2001 MI 2.0 2 .6 M 01/05/2001 The pt's mother noticed a reddened area that was 2x1 inch in diameter on his right thigh up to his buttocks on 12/28/00. On 12/29/00 this area became ecchymotic. On 1/4/01, the pt's mother noticed small slightly raised reddened bumps and red "lines" 1 inch long appearing randomly on the left thigh form mid thigh to the knee covering an area of 1 1/2/ in wide by 2 3/4 inches long. On 1/6/01, the mother noticed the rash and ecchymotic area had disappeared. No further symptoms noted. Y 12/27/2000 12/28/2000 1 PUB PUB cold meds, multi-vitamins mild cold NONE MI2001002 1
0164778 01/17/2001 IL 1.25 1 .2 M 12/18/2000 Approximately 12 hours post vax, the pt had a short febrile seizure. The pt fully recovered. Y 12/14/2000 12/15/2000 1 NONE PVT PVT NONE NONE 1
0164779 01/17/2001 MI 0.5 0 .5 M 01/09/2001 Same day as vax, the pt experienced tiredness and irritability, refused to use his legs, he was up all that night "screaming" and holding his legs out straight, injection site was red with slight swelling. Tylenol given once during the night. The next day, the child remains irritable. Was seen by PCP. No signs of ear infection or URI, no fever. Child has improved by 1/6/01. Y 01/04/2001 01/04/2001 0 NONE PUB PUB NONE NONE NONE MI2000003 1
0164780 01/17/2001 AR 68.0 78 M 12/07/2000 About midnight the evening of the vax, the pt woke up and went to the bathroom and began to have chills for about 30-40 minutes. The pt felt bad the rest of the night and day, was weak with occasional shorter chills. Did not check temp. Feels ok today 12/7/00. Y 12/05/2000 12/05/2000 0 PUB UNK NONE NONE AR0101 1
0164781 01/17/2001 UT 73.0 73 F 01/04/2001 The pt experienced adverse reactions from the flu vaccine at the injection site which included redness, swelling (grapefruit size in diameter), rash, itching, symptoms began to resolve by 1/2/01 when she called the pharmacy. Y 12/29/2000 12/30/2000 1 NONE OTH PVT NONE NONE NONE 1
0164782 01/17/2001 MI 38.0 38 F 01/08/2001 One day post vax, the pt developed a rash on upper anterior and posterior chest. Treated with over the counter medications and then resolved. Y Y 12/06/2000 12/07/2000 1 NONE PUB PVT NONE allergy to PCN, sulfa, Flagyl, Benadryl, Atarax, Thimerosal 1
0164783 01/17/2001 TN 57.0 57 F 12/20/2000 The pt experienced a localized red and warm area at the injection site. This subsided in about 3 days after it appeared. No other symptoms were experienced. Y 11/14/2000 11/15/2000 1 OTH PVT 1
0164784 01/17/2001 VA 40.0 40 F 12/15/2000 The pt experienced numbness in the right arm immediately following the vax. The pt also experienced discoloration of the arm and swelling of the right hand, and flushed face. By 10:30 am, the face became pale and a red rash appeared. BP 163/103 and a rapid pulse of 103-105. Diagnosis of anaphylactic reaction treated with Benadryl. Y Y 12/15/2000 12/15/2000 0 PUB PUB NONE hypothyroid, allergy to sulfa numbness in left arm~Influenza (Seasonal) (no brand name)~~39.00~In Patient 1
0164785 01/17/2001 ID 39.0 39 F 11/22/2000 The pt experienced neurological symptoms which included numbness and tingling in legs and hands. The pt was diagnosed with Type I multiple sclerosis on 4/30/00. Was in remission at the time of vaccination. Y Y 11/06/2000 11/09/2000 3 NONE PVT PVT Avonex, glucosamine multiple sclerosis - in remission ID00054 1
0164786 01/17/2001 CA F 01/10/2001 The pt experienced red arm inflammation which was red and sore. The arm was difficult to mobilize and was painful. The area was from the deltoid to the elbow. It was hot to the touch. The pt was treated with Tylenol and Benadryl. N 12/13/2000 OTH PVT 1
0164787 01/17/2001 MA 17.0 17 F The pt developed localized redness, warmth, swelling and itching. The pt also experienced fever of 99.6 and dizziness. U 01/09/2001 01/10/2001 1 OTH PUB NONE NONE NONE 1
0164788 01/17/2001 MA 17.0 16 F On 1/10/01, the pt developed localized redness, warmth, swelling, itchiness, fever of 99.6 and dizziness. U 01/09/2001 01/10/2001 1 OTH PUB NONE NONE NONE 1
0164789 01/17/2001 SC 36.0 35 F 12/14/2000 On 12/2/00 the pt complained of left arm weakness, pain in left upper arm, numbness in fingers on left hand and an aching in left arm. Constant ache continued until 12/6/00. She tool OTC Advil for pain relief on 12/2/00 and 12/3/00. She reported these symptoms to her MD. Y 11/30/2000 12/02/2000 2 PUB PUB NONE NONE NONE SC00091 1
0164790 01/17/2001 CA 34.0 34 M 12/18/2000 The pt complained of discomfort to the arm pit, inner aspect, LUE when raising arm up. The pt had palpable lymph nodes X 3 in left arm pit. No neuro deficit. Neurological checks equal bilateral adequate ROM. U 10/25/2000 10/27/2000 2 PVT UNK NONE NONE NONE 1
0164791 01/17/2001 MI 68.0 68 F 12/27/2000 The pt's left arm began to swell shortly after receiving the vaccines. The pt saw an internist on 12/20/00. The pt was treated with Benadryl and Allegra. The arm continues to itch and the swelling is decreasing. Y Y 12/19/2000 12/19/2000 0 PUB PUB Coumadin MI2001001 1
0164792 01/17/2001 MA 30.0 30 M 01/02/2001 Approximately 2 days after receiving vaccine, the patient developed a sore throat, low grade fever, and muscle aches. All symptoms resolved on their own;within another 72 hours. Y 12/20/2000 12/22/2000 2 Did not seek medical attention PUB UNK NONE NONE 1
0164793 01/17/2001 FL 7.0 2 .0 M 01/08/2001 This child is positive for varicella, he has 20 or more vesicles. Y Y 08/24/1995 12/27/2000 1952 Tzanck Smear - Positive varicella PVT PVT Developmental delay, communications disorder. 1
0164794 01/17/2001 SC 1.3 1 .4 F 11/30/2000 This patient had a 10cm circular red induration around the site of injection. No secondary infection. Resolved with rest, oral Benadryl. Y 11/28/2000 11/29/2000 1 MIL MIL NONE NONE NONE 1
0164795 01/17/2001 SC 1.25 1 .2 U 10/30/2000 This infant had vaccination, 4 days later developed urticaria that started at the head then spread to the face and trunk over 2-3 days. Resolved spontaneously after 2 weeks. No other symptoms. Y 10/12/2000 10/16/2000 4 NONE MIL MIL NONE NONE NONE 1
0164796 01/17/2001 CA 31.0 31 F 01/10/2001 This patient had a fever, fatigue, clouded thinking, swelling, pain and redness of left arm and left breast. She required time off from work; symptoms improved after 48 hours. Y 01/08/2001 01/08/2001 0 NONE PVT OTH Synthroid, Flonase, Flovent. Triphasil, Celexa, Singulair. NONE Allergy to dust mites, asthma, complex aphthosis fever, swelling, pain, 3 days home from work~Pneumo (no brand name)~1~26.00~In Patient 1
0164797 01/17/2001 CA 1.3 1 .4 M 01/04/2001 This patient had a 4 inch diameter, red, swollen area at the site of injection, warm to touch. The patient still irritable , no fever. Y 01/03/2001 01/04/2001 1 PVT PVT NONE 1
0164798 01/17/2001 DC 4.0 4 F 01/05/2001 This child had an abscess at the vaccine site, left arm. Y U 01/03/2001 01/04/2001 1 PUB UNK 1
0164799 01/17/2001 OR 70.0 69 F 12/27/2000 This patient complains of painful right arm from neck to fingers with difficulty lifting arm due to the pain. The patient has not yet sought treatment. She was advised to have her physician evaluate. U 10/02/2000 10/04/2000 2 PUB PVT Tylenol Allergic to ASA and Erythromycin. OR200043 1
0164800 01/17/2001 CA 4.0 4 M 01/05/2001 This patient's entire left upper arm is swollen with a blotchy itchy rash. U 01/03/2001 01/03/2001 0 NONE PVT PVT NONE NONE NONE 1
0164801 01/17/2001 LA 11.0 11 F 01/04/2001 This patient had an injection; the site (left deltoid) became painful the afternoon of the injection with redness 4-5 inches in circumference. Occuring approximately 24 hours after the injection and has not worsened since then. She states it is slightly less red. We saw the patient (11 y/o) came in with her guardian for immunizations 2 days ago and the guardian was unaware of the patient's history of 1-2 years ago when she received TD following a dog bite and injection site became red, swollen, and oozing. The patient referred to private MD for evaluation today. Y U 01/02/2001 01/02/2001 0 PUB PUB LA010102 1
0164802 01/17/2001 FL 51.0 51 F 01/11/2001 A week after this patient's shot, on 07/10/00, in the left arm, her left arm was very painful. The patient started to get stabbing pains in the arm; she could not move her arm. The patient had 9 weeks of physical therapy. Nothing helps. She can't sleep at night due to the pain. The patient also had a Cortizone shot, it did not help. Y N 07/10/2000 07/22/2000 12 On MRI - found inflammation PVT OTH Synthroid NONE Thyroid 1
0164803 01/17/2001 CA 11.0 11 M 01/11/2001 This child had 1.0 ml of Hep B vaccine immediately; stiffening of all limbs, rolling of eyeballs, jerking of lower extremities, felt dizzy, and became sweaty. The initial BP increased then stabilized.; Y 01/08/2001 01/08/2001 0 PVT OTH Mantoux (Connaught), Lot # C0152AA, left arm, 3 doses. NONE NONE 1
0164804 01/17/2001 AK 9.0 9 F 10/20/2000 This child has a rash, pruritis of both arms, hands, and face; one hour after vaccination. No history of allergies. No respiratory distress, temperature of 99. Home with dad. Y 10/19/2000 10/19/2000 0 NONE OTH PUB NONE NONE NONE 1
0164805 01/17/2001 TX 12.0 12 M 01/10/2001 This patient had a sore throat 2 days before he got his vaccine on 01/08/01. On 01/10/01, he had a maculopapular red rash on his body and head, exudate on tonsils, nasal congestion. Took 2 Penicillin (Amoxicillin) on 01/09/01. Y 01/08/2001 01/10/2001 2 Monospot, Throat Culture, CBC w/ Diff. OTH PUB Amoxicillin 01/09/01 NONE 1
0164806 01/17/2001 SC 0.2 0 .2 M 01/04/2001 This infant had immunization on 12/29/2000. On 12/30/00, at 3 AM, he had a temperature of 104.7; given Tylenol. On 12/30/00, at 8 AM, he had a temperature of 103.1. On 1230/00, at 1 PM last temperature was 101. The infant was irritable, decreased appetite (nursing for shorter periods). Y Y 12/29/2000 12/30/2000 1 PVT PUB NONE 1
0164807 01/17/2001 SC 0.3 0 .4 M This patient had immunizations given on 12/29/00. On 12/30/00, episodes of increased irritability alternating with, "staring off like he was some where else", no blinking of eyes, no movements for 1-2 minutes, increased temperature, and a rash for 3 days. Y Y 12/29/2000 12/30/2000 1 PVT PUB 1
0164808 01/17/2001 TX 1.2 1 .1 F 01/10/2001 This infant had erythema around the injection site on the left thigh. U 01/08/2001 01/09/2001 1 PVT OTH Stated Amoxicillin with shots. Acute Otitis Media Surgical repair of club feet. 1
0164809 01/17/2001 IL 1.0 1 .0 F 01/08/2001 The pt experienced a vaccine associated varicella rash. Y 01/02/2001 01/07/2001 5 UNK PVT NONE 1
0164810 01/17/2001 MS 9.0 9 M 01/10/2001 Approximately 2 hours after receiving his injection the child became combative, irritable, sensitive to touch, hyperactive, banged head on wall, also experienced headache, Temperature 100, diarrhea 4 times. The side effects lasted from 12/8/00 - 12/10/00. The mother stated the child started behaving normally about 7 PM on 12/10/00. He had no problems with his sleep. Y 12/08/2000 12/08/2000 0 NONE PUB OTH NONE NONE NONE MS01001 1
0164811 01/17/2001 IL 5.0 5 M 01/08/2001 This child had severe parotitis ,along with facial pain, low grade temp; exactly 1 week post vaccination. The mother consulted the pediatrician by phone. The parotitis resolved completely after 3 days without treatment. Y 10/10/2000 10/17/2000 7 NONE PUB PUB NONE NONE NONE IL01001 1
0164812 01/17/2001 GA 12.0 12 F 01/10/2001 This patient had a rash, and papular patches develop on her arms, exterior surfaces, spread to her shoulders, legs, and also facial edema; on Saturday. Medrol IM given in the office and Allegra. Y Y 01/05/2001 01/06/2001 1 Will do Hep titer in 6 months. OTH PUB Emycin topical solution for 6 months. 1
0164813 01/17/2001 PA 1.0 1 .0 F 01/09/2001 This infant had a rash all over. Reported by the mother. Not seen by health care provider. Y 10/03/2000 10/14/2000 11 NONE PVT PVT Tuberculin Skin Test NONE NONE 1
0164814 01/17/2001 AR 12.0 12 M 01/02/2000 This patient had vaccination, he walked approximately 20 and passed out. He became alert almost immediately. The mother said he had not eaten, the patient was given sprite and told to lye down 5-10 minutes. The patient appeared fine and left health unit. Y 01/02/2001 01/02/2001 0 PUB UNK NONE NONE NONE AR0104 1
0164815 01/17/2001 CA 1.4 1 .5 M 01/03/2001 This infant had an injection, about 25 hours after the parent noted that the left upper arm was hot and swollen, no fever, appetite good, normal activity. They returned to the clinic the examiner noted that the left deltoid area was inflammed and indurated. At the clinic given children's Advil. On 12/31, the mother reported the arm was completely normal. Y 12/27/2000 12/28/2000 1 NONE PUB PUB NONE NONE NONE CA000157 1
0164816 01/17/2001 SC 82.0 82 F 12/11/2000 This patient was given a tetanus shot on 11/21/00. The patient called 2 weeks later stating her right arm where the injection was given was swollen, red, and blisters around the swollen area. She consulted with a doctor and the doctor suggested ice to the arm. If not better within 24 hours to see private MD. 12/11/00, the patient states she is completely recovered. Y 11/21/2000 11/28/2000 7 PUB UNK SC00090 1
0164817 01/17/2001 PA 48.0 48 F 01/10/2001 This patient's left tricep is "burning" in the first three weeks after her shot. On Dec 8, 2000, after the patient returned from her Africa trip, she notes one axillary node enlarged, but neck trapezoid area felt sore; possibly from flight. The patient continues to have soreness / ache in deep area left upper arm and neck. U 10/10/2000 10/17/2000 7 NONE PVT PVT NONE NONE NONE 1
0164818 01/17/2001 AR 27.0 27 F 10/24/2000 This patient had an injection, within 10 - 20 seconds after the injection, she had a large reddened area 3 inches round in size develop. The patient stated this injection was very painful, no swelling noted, only redness. The patient was observed before leaving unit. The nurse was notified. On 11/14/00 the patient called and reported she did not see the MD as was recommended. Y 10/24/2000 10/24/2000 0 PUB UNK NONE NONE NONE AR0103 1
0164819 01/17/2001 CO 5.0 5 M 05/08/2000 This patient was given an MMR vaccination to the left arm. As soon as he got the injection the patient had a red rash covering injection site and 1/2 the arm, plus red spots started to break out on his back. Went to get the doctor to look at the patient right away. The patient was given Benadryl, it helped control the rash and it started disappearing in some areas before the patient left. The mother was told to continue Benadryl. Y Y 05/08/2000 05/08/2000 0 PVT PVT NONE 1
0164820 01/18/2001 ME 39.0 39 F 01/10/2001 Information has been received from a physician concerning a 39 year old female with past varicella exposure who on 3/22/00 tested negative for varicella antibodies. Subsequently, on 3/27/00, the pt was vaccinated with 1 dose of varicella virus vaccine live. On 4/3/00, the pt learned that she was pregnant. Approx. LMP: 2/27/00, and estimated delivery date: 12/3/00. The pt miscarried on 5/1/00, at 9 1/2 weeks gestation. Additional information has been requested. Y N 03/27/2000 05/01/2000 35 lab test - neg varicella antibodies PVT OTH UNK varicella exposure WAES00040262 1
0164822 01/18/2001 OH 0 .0 F 01/16/2001 The pt experienced seizures x 3 approximately 5 hours post vax. The infant was treated with Phenobarbital and was transferred to a tertiary care facility. No neurological abnormalities identified. The pt was discharged to the home with parents. Y Y 01/10/2001 01/10/2001 0 EEG, Echocardiogram - WNL PUB PUB Vitamin K, Erythromycin NONE NONE 1
0164823 01/18/2001 KY 3.5 3 F 01/16/2001 The pt felt warm to the touch on the evening of 1/11/01. Woke at 6:50 a.m. with wheezing / problems breathing. The pt vomited 1 time and became limp. ? seizure. Seen in the doctors office. The follow-up states that she has an obvious left hemiparesis, and she has some dystonic posturing of her left hand. She walks well with a minimal limp. She has a migrational disorder. This gives her the motor handicap. Decided to start her on Tegretol. Follow up on 11/06/2003: "Vaccine recipient did recover from the adverse event." Y Y 1 N 01/11/2001 01/12/2001 1 PUB OTH NONE Cerebral Palsy; febrile seizure, 6 months ago. KY2001002 1
0164828 01/18/2001 NY 13.0 13 F 01/15/2001 Approximately 2 days post vax on 5/7/00, she experienced mild sporadic joint pain which did not resolve. A doctor visit was required. A few days following the 2nd dose, the pt experienced joint swelling. In 7/00 every joint in the the pt's body "blew up". The mother stated that the pt's toes and fingers were twisted. She experienced arthralgias, swollen fingers and stiff elbows. Pains were worst in the afternoon. She had morning stiffness alleviated with walking. Over the next two weeks she began to have problems with both knees and difficulty going up and down the stairs. She experienced considerable difficulty with activity. the pt's mother felt that the pt continued to be symptomatic, worse when it rained in the morning, worse when she was very active. The pt had no fever, rash, abdominal pain, alopecia, mouth sores, chest pain, diarrhea or nausea. On 8/5/00 she was started on Amoxicillin and ibuprofen. On her 8/24/00 follow-up visit with the pediatric rheumatologist, the pt had no improvement in her symptoms, her wrist arthritis had progressed with extension limited to 70 degrees on the right. She had morning stiffness lasting 60 minutes. The pt recommended starting methotrexate and considered the possibility of using etanercept which would be given SC twice weekly. The pt's mother felt that the naproxen had been entirely ineffective. The mother had purchased a number of over-the-counter herbal supplements and also had the pt sleeping on a magnetic bed but felt that the magnetic bed had not provided any relief. Impression: the pt most likely has an acute reactive arthritis. The physician found nothing to substantiate a diagnosis of polyarticular juvenile rheumatoid arthritis. The physician stated that the pt's arthritis may be related to Engerix-B. The physician recommended Relafen. A Rheumatology panel taken on 9/1/00 was within normal limits. On 9/22/00 the pt had a visit with the pediatric Rheumatology. The pt has been taking methotrexate and prednisone. She continued to have fuciform swelling of the proximal interphalangeal joints bilaterally and left wrist swelling which interfered with her violin playing. She continued to have morning stiffness lasting 60 minutes. the pt was re-started on naproxen. The pt's methotrexate dose was increased. The physician stated the polyarticular juvenile arthritis started on 10/8/00. At the 10/17/00 follow-up visit, morning stiffness had decreased to 15 minutes. 11/9/00 physician's visit revealed that the pt's PIP joints were less swollen as was the left wrist. She continued to have morning stiffness lasting 15-20 minutes. She has been using a paraffin bath and was doing some hand and wrist exercises. The pediatrician stated that the pt's arthritis was moderate in severity and possible related to Engerix. The physician stated that the adverse events were disabling/incapacitating, and that the pt could no longer play the violin. As of 1/12/01, the outcome of the events is ongoing. F/U on 4/15/01, the physician reported that the pt continued to have active polyarticular rheumatoid arthritis with persistent swelling of wrist and proximal interphalangeal joints. She continued to receive maximal doses of methotraxate and was also receiving Lodine. The physician was considering TNF (tumor necrosis factor) - alpha blockage. On the current regiment her sedimentation rate was normal. She was still unable to play the violin due to stiffness in her fingers and wrists. On 7/27/01, the physician reported that the pt continued (as of 5/01) to have symptomatic polyarticular rheumatoid arthritis under somewhat better control. Swelling of the wrist had subsided there was full range of motion. PIP joints remained swollen but had good range of motion. Cervical spine lateral flexion was limited. The pt continued on maximal doses of methotrexate and was also taking lodine. On the current regimen her sedimentation rate was normal. She still was unable to play the violin due to stiffness in her fingers and wrist. Y Y N 06/07/2000 Labs; ASLO-neg; Adenovirus titer-neg;EBV-neg; CBC and ESR-unremarkable; ANA-neg; Parvovirus IGG positive with negative IGM consistent with prior infection; Radiographs-neg for both wrists and hands; no erosions or periarticular demineralization PVT PVT vitamins (nos) "Adenoids", cardiac symptoms (nos), HLA-DR4 positive, Lyme Disease at age 5. Menarche occurred this month. The vaccinee's mother has mild osteoarthritis. ~Hep B (Engerix-B)~1~10.00~In Sibling 20000318651 1
0164832 01/18/2001 TN 0 .0 M 12/26/2000 On 10/27/00 the pt was rushed to the doctor with colic like symptoms, jaundice, not eating, running a fever of 101.1. A lumbar puncture was performed and meningitis was found. The pt was admitted to the hospital and stayed for 14 days. The pt is still recovering from minor side effects. Y Y Y 14 Y 10/11/2000 10/27/2000 16 Had to do 4 LP's to make sure. Dx'd with meningitis. PUB UNK NONE 1
0164833 01/18/2001 PA 41.0 41 F 01/12/2001 Constant pain in entire body, severe joint pain in ankle, wrist, knee and shoulder; needle-like pains in right arm, deterioration of vision, shooting pains in arms and legs, traveling pains in upper back, sleeplessness, fatigue, stiff neck and myalgia. 60 day follow-up states the pt us unable to function without medication. Y Y N 03/26/1999 03/27/1999 1 PVT PVT NONE 1
0164834 01/18/2001 OH 0.2 0 .2 F 01/08/2001 The pt experienced an apparent apneic episode after feeding, some pallor, perioral cyanosis, hypotonia, hypo-responsive noted. The pt experienced a spontaneous full return to normal color, tone, mental status within 5-10 minutes. Was transferred to the hospital for tests and observation. Y 2 Y 11/08/2000 11/08/2000 0 septic work-up - blood urine, CSF - all neg, EEG - neg PVT PVT NONE chalasia (spittiness - reflux) 1
0164835 01/18/2001 MI 37.0 37 F 01/05/2001 The employee was given the flu vaccine at approximately 10:45 and within 15 minutes experienced a rash, tightening of the throat, wheezing and difficulty breathing. The pt was treated with epinephrine and Benadryl. Called 911 for transport to the hospital. After receiving medications, breathing improved. The type of reportable event was anaphylactic reaction. Y Y 12/12/2000 12/12/2000 0 UNK UNK hx of asthma (seasonal) 1
0164836 01/18/2001 CA 1.0 1 .0 M 01/10/2001 On 6/1/00, the pt was hospitalized for seizures and otitis media. An EEG was performed and the results were not provided. The pt was hospitalized again on 6/4/00 and was diagnosed with epilepsy. He was treated with Phenobarbital and had partially recovered. It was reported that the investigator and medical monitor agreed that the "epilepsy, otitis media and congenital abnormality were not reasonably related to Prevnar administration", however the relationship to varicella virus vaccine, MMR was unknown. Upon medical review, seizures were considered to be an "other important medical event". Additional information has been requested. Y N 05/23/2000 06/01/2000 9 electroencephalography - results not provided PVT PVT Central nervous system anomaly WAES00122054 1
0164840 01/18/2001 CA 2.08 2 .1 M 01/10/2001 On 5/27/00, the pt was seen in a clinic and was diagnosed with seizure and upper respiratory infection. The child partially recovered. On 6/2/00, the pt was placed on therapy with Carbamazepine. Both the investigator and the medical monitor agree that the epilepsy and the URI are not reasonable related to the Prevnar administration. The relationship of the seizure, epilepsy and URI to the MMR and Varicella is unknown. Epilepsy and seizure were considered to be an "other important medical event". Additional information has been requested. Y U 05/17/2000 05/27/2000 10 MRI - nml PVT PVT Hospitalization; seizure; speech disorder WAES00122050 1
0164842 01/18/2001 CA 36.0 F 01/15/2001 On 2/18/00, the pt received her 1st injection with Engerix-B. On 3/6/00, she had a pregnancy test which was positive. The pt's last menstrual period was 2/6/00 and the estimated date of delivery was 11/13/00. She had been pregnant for 6 weeks on 3/15/00. The information received on 1/12/01, reported the pt had a miscarriage. No further details were provided. This report was assessed as medically serious. Additional information has been requested. Y U 02/18/2000 pregnancy test - pos PVT OTH allergy to Benadryl 20000084291 1
0164843 01/18/2001 TX 0.2 0 .2 F 01/08/2001 The pt experienced a low grade fever on 1/3/01, up to 99 on 1/4/01, up to 101 - 102 on 1/5/01. The pt still had a temp of 102 and looked ill on 1/6/01 and mom took the pt to the ER and was admitted to the hospital. Y Y U 01/02/2001 01/03/2001 1 PVT PVT NONE NONE 1
0164844 01/18/2001 MI 36.0 M 01/11/2001 Patient developed joint aches (especially elbows) and chronic fatigue approximately 30 days after vaccine. MIL UNK NONE NONE NONE 1
0164845 01/18/2001 AZ 0.6 0 .6 M 01/12/2001 Patient developed rash on abdomen, as noted by mother, on the morning of 1/12/01. She also noted a fever of 103 degrees and gave Advil which reduced the temperature to 99 degrees. No other symptoms reported by mother. Rash on abdomen noted by mother in AM of 01/12/2001. Also noted fever of 103 degrees and gave Advil which reduced temperature to 99 degrees. No other symptoms reported by mother. U 01/11/2001 01/12/2001 1 PVT UNK Mild eczema 1
0164846 01/18/2001 AZ 1.25 1 .3 M 01/16/2001 Patient developed febrile seizure and vomiting. He was taken to the ER and given IV fluids. A UA and CT of head were performed. He was started on antibiotics. Y Y 01/09/2001 01/11/2001 2 UA, CT Scan of head PVT PVT Possible acute gastroenteritis NONE 1
0164847 01/18/2001 CO 4.0 4 M Patient developed red dots surrounding eyes after clinic visit on 11/3/00 and returned to clinic that day with mother. Fine petechiae were noted to left periorbital region, to skin immediately below eyebrow and to external lateral side and bottom of left eye. No edema, pruritus, or respiratory problems were observed. The patient was happy, alert, smiling and in no acute distress. Per mother, the dots had faded by the morning of 11/4/00. Y 11/03/2000 11/03/2000 0 NONE PUB UNK NONE NONE NONE 1
0164848 01/18/2001 PA 0.2 0 .2 F 01/10/2001 Patient received DTAP, Prevnar, HIB and IPV on 1/04/2001. Mother called office on 1/06/2001 at 10:45AM to report that patient had been inconsolable and crying from 6PM to 6AM the previous night. Y 01/04/2001 01/05/2001 1 PVT PVT NONE NONE 1
0164849 01/18/2001 TX 0.3 0 .3 F 01/10/2001 Patient developed a high fever to 105 degrees with temperature staying 102 degrees for 12 to 24 hours. Note: Patient had similar febrile response to first set of immunizations on 11/09/2000. Temperature went up to 103 degrees and lasted 24 hours. Y 01/09/2001 01/09/2001 0 NONE PVT PVT NONE NONE NONE Fever 103~DTaP (Infanrix)~0~0.00~In Patient 1
0164850 01/18/2001 CA 0.3 0 .4 M 01/03/2001 Patient developed inconsolable crying for 3 to 5 hours at a time with brief, 1/2 to 3/4 hour, periods of rest in spite of Tylenol and Motrin and other comfort measures. Patient had slow improvement over 7 to 8 days. Patient had a fever and was given Tylenol every 4 hours and Motrin every 6 hours. Patient developed a rash and had a decreased appetite. ER report indicated patient was "fussy" but episode was beyond being fussy. Y Y 10/30/2000 10/30/2000 0 CBC PUB PUB NONE NONE 1
0164851 01/18/2001 IL 0.08 0 .2 F 01/11/2001 The DTAP vaccine was given to the patient for the first time in the left thigh. Immediately following the injection, the leg became reddened down to the knee, and a rash appeared on the patient's stomach. Ice was applied to the leg for 15 minutes. After 40 minutes, the leg became normal and the rash on the stomach disappeared. Y 01/04/2001 01/04/2001 0 NONE PVT PVT NONE NONE NONE 1
0164852 01/18/2001 TX 1.25 1 .3 M 01/04/2001 Patient developed a 10 cm red, indurated, warm area over the left thigh where he received the DTAP/Hib combination. Y 12/05/2000 12/06/2000 1 NONE PVT PVT NONE NONE NONE 1
0164853 01/18/2001 WA 0.2 0 .2 F Within 5 minutes of receiving vaccination, the patient became pale, listless, and legs looked slightly swollen. Symptoms resolved in 15-30 minutes. No further problems were noted. Y 11/09/2000 11/09/2000 0 NONE PVT PVT NONE Hemoglobin D trait 1
0164854 01/18/2001 PA 63.0 63 F 01/10/2001 Approximately 2 weeks after receiving Lymerix #2, the patient developed an ache in her arm at the injection site. The pain worsened and spread up her left arm to her shoulder and neck. The pain increased, and now the patient has pain in all her joints and muscles. This problem has not been helped by treatment with Prednisone, muscle relaxants, or anti-inflammatory medications. N 09/13/2000 09/25/2000 12 X-rays and MRIs of arm, shoulder and cervical spine-neg ESR and lyme titre-neg PVT OTH Calan, Paxil, E-vista, Dyazide, Hytrin, Zyrtec, Vioxx NONE Penicillin, E-mycin, sulfa, morphine, Demerol, iodine, Keflex 1
0164855 01/18/2001 PA 1.75 2 .8 M 01/05/2001 In the afternoon and evening of 1/2, the patient developed redness, swelling and pain at the injection site on the left anterior thigh. On 1/3, the pain decreased but the swelling continued to increase through 1/4. Upon examination on 1/4, the left anterior lateral and posterior thigh were red, warm and swollen but not painful. At 11cm above the patella, the right thigh was 29cm and the left thigh was 31.5cm. Y Y 01/02/2001 01/02/2001 0 NONE PVT PVT NONE NONE NONE 1
0164856 01/18/2001 NJ 65.0 64 M 12/28/2000 Patient developed pain and swelling of fingers, wrists, knee, right ankle and toes in mid-March of 2000 just before time to take the last lyme shot. N 05/13/1999 03/01/2000 293 Blood test and X-rays showed no lyme disease but was diagnosed as rheumatoid arthritis. PVT UNK NONE 1
0164857 01/18/2001 CA 0.3 0 .2 F 01/10/2001 Patient developed inconsolable crying for 2-3 hours and could not be put down despite Tylenol. Y 11/16/2000 11/16/2000 0 NONE PVT PVT NONE NONE NONE 1
0164858 01/18/2001 TN 0.25 0 .3 M 01/11/2001 Patient developed constant crying. Y 01/05/2001 01/05/2001 0 NONE UNK UNK NONE NONE 1
0164859 01/18/2001 PA 62.0 62 F 01/08/2001 6/5/00 Patient noted to have multiple hive-like eruptions on her back which were red, slightly raised and diffuse but not itchy. Prior to this eruption, patient had been outdoors weeding and noticed a few insect bites on knees and back of neck. 6/11/00 Patient felt shaky with abnormal stool. She was seen in the ER and treated with IV fluids for dehydration. 6/13/00 Patient was seen by family physician still shaky and unsteady with frequent stools. Patient had probable intestinal virus and was improved by 6/24/00. 6/26/00 Patient became lightheaded, tired, woozy and had difficulty focusing. She had a 3 to 4 week period of transient lightheadedness, depth perception difficulty, chills and fatigue. 8/10/00 Patient continued with fatigue and lightheadedness. 8/31/00 Patient had episode of horizontal wavy lines in vision. She was seen by an infectious disease physician with probable Lyme. She was given an RX for doxycycline, 100mg daily x 21. 9/18/00 Patient experienced wavy lines in vision and tumbling sensation. 9/19/00 Patient seen by infectious disease physician and referred to neurology, possible Meniere's Disease, possible vestibular problem. Patient given second series of doxycycline. 10/00 Patient seen by neurology and ENT. Infectious disease physician states possible mono. 11/6/00 Patient sought second opinion. 12/3/00 Patient received oral antibiotics with some improvement. Y 05/31/2000 06/05/2000 5 6/11/00 EKG, chest X-ray, stool testing, blood work-all neg. 6/13/00 BP, thyroid, CBC, electrolytes-all wnl. 6/29/00 ELISA, Epstein Barr, Mono spot-all pos. Western Blot-borderline. 8/10/00 Western Blot-borderline. Mono spot-pos. Screening for multiple myeloma and lymphoma-neg. 8/13/00 Screening for Rocky Mountain Spotted Fever, Typhus Fever, Coxsackie virus-all neg. 9/19/00 Western Blot-highly positive. 10/00 EEG, MRI, ENG-all not significant. 11/6/00 Western Blot reactive, Ehrlichosis-neg, Babesia-borderline but repeat neg. Screening for lupus and MS-neg. 11/27/00 Brain Spect-moderate heterogenous global hypoperfusion and moderate prominence of the white matter. 12/4/00 Lyme disease serology CSF-reactive. Lyme disease serology serum-reactive. Lyme immunoblot CSF-IgM negative, IgG indeterminate. Lyme immunoblot serum-IgM-indeterminate, IgG-indeterminate. PVT PVT Prinivil, Premarin, Provera, ASA, Tums, Vit E, multivitamin NONE Mild hypertension, Hx of hepatitis B, hypercholesterolemia 1
0164860 01/18/2001 MI 26.0 26 F 01/15/2001 In the PM of 01/11/01, patient's left deltoid area became reddened and swollen with a burning sensation. This increased overnight, and by 9AM on 01/12/01, the area involved was red and about 4cm oval. Patient took 2 ibuprofen (400mg) once on 01/12/01 and did not receive any other treatment. On 01/15/01, there was no redness, swelling, or burning sensation. Y 01/11/2001 01/11/2001 0 NONE UNK UNK Glucophage, Paxil NONE NONE ~Influenza (Seasonal) (no brand name)~1~23.00~In Patient 1
0164861 01/18/2001 NY 5.0 5 F 01/10/2001 Patient developed erythematous, generalized, somewhat itchy rash 72 hours after flu vaccine. Follow-up on day 5 showed a generalized, papular macular erythematous rash that was mildly raised. Y Y 01/05/2001 01/08/2001 3 NONE OTH PUB NONE NONE Asthma 1
0164862 01/18/2001 NV 45.0 45 F 01/09/2001 Patient noted heaviness in chest and had to take deep breaths to feel she was getting any oxygen. She had an erratic heartbeat and could feel it jumping. She was pale with red eyes. Chest heaviness and erratic heartbeat were relieved by the morning of 01/06/01. Patient reported no wheezing or sore throat. Y 01/05/2001 01/05/2001 0 NONE PUB OTH NONE NONE NONE NV01 1
0164863 01/18/2001 IA 45.0 45 F 01/12/2001 Patient developed arm discomfort at site of injection for one month post administration. No medical treatment was sought. Patient took anti-inflammatory medication and used heat. 12/13/2000 12/16/2000 3 UNK UNK 1
0164864 01/18/2001 IA 35.0 35 F 01/12/2001 Patient developed arm discomfort at site of injection one month post administration. No medical treatment was sought. Patient took over-the-counter pain relievers. There was no disability or inability to use the arm. 12/13/2000 UNK OTH PVT UNK UNK UNK 1
0164865 01/18/2001 WI 57.0 57 M 01/01/2001 One day post vaccine, the patient felt spaced out, like in a different reality. Patient noted that he takes about 15 vitamin pills. Y 12/14/2000 12/15/2000 1 OTH UNK NONE NONE NONE 1
0164866 01/18/2001 MD 45.0 45 F 01/08/2001 Patient noted to have rash on both arms and chest that became itchy. Y 11/17/2000 11/18/2000 1 PUB PUB NJ200026 1
0164867 01/18/2001 IA 10.75 10 M 11/27/2000 11/20/00 Patient developed stiff neck. He had no fever. Upon movement, his neck was supple, but he had pain in the muscles of his neck and had a hard time holding his neck up. His leg extension test was normal. There was no adenitis. The doctor's impression was muscle inflammation from viral infection, possibly related to his recent flu shot. Y 11/17/2000 11/19/2000 2 PVT PVT Flovent, Maxair NONE Asthma ID00053 1
0164868 01/18/2001 MA 43.0 42 M 01/09/2001 Approximately 3 hours after vaccine, patient developed filmy, blurry eyes with a slight discharge from the inner corners. Patient noted blurring of vision in both eyes and eyes felt strange. Upon awakening, eyes were crusty and very bloodshot. The symptoms lasted all day and ended within 24 hours. Y 12/09/2000 12/09/2000 0 NONE OTH PVT NONE NONE Annual response to poison ivy 1
0164869 01/18/2001 OR 45.0 45 M 01/09/2001 Patient developed onset of right parascapular pain on 12/2/00. He had onset of right hand weakness and incoordination on 12/6/00. Specifically, he had weakness of the thumb and abduction of fingers with decreased pinch and grip strength. Tentative diagnosis is brachial plexitis. Y U 10/10/2000 12/02/2000 53 C-spine MRI not significant, brain MRI pending, considering MRI of brachial plexus. OTH OTH lisinopril NONE Hypertension 1
0164870 01/18/2001 TX 63.0 63 F 01/08/2001 Patient developed pain, discomfort and immobility in left arm and sought medical care. She was referred to a sports medicine clinic for evaluation and possible physical therapy. Patient's husband reported to County Health Dept on 1/2/01. Y U 11/01/2000 PUB UNK 1
0164871 01/18/2001 CA 29.0 29 M 01/02/2001 Patient noted to be feeling faint and weak. Patient had questionable diagnosis of vasovagal syncope. Y 12/28/2000 12/28/2000 0 PVT UNK History of mental retardation and asthma 1
0164872 01/18/2001 CT 30.0 30 F 01/12/2001 Patient developed redness, itching, and swelling from elbow to top of upper arm. Patient still had symptoms 4 days after the vaccine but was improving. N 01/08/2001 01/08/2001 0 OTH PUB Allese NONE Bee sting, wine and champagne allergies 1
0164873 01/18/2001 WI 8.0 F 01/08/2001 Patient noted swelling in left arm twenty four hours after receiving vaccine. During 1/6/01 exam, right deltoid showed a non-tender, red, warm circle 8cm x 6.5cm. She was treated with Benadryl and cool compresses. Y Y 01/04/2001 01/05/2001 1 PVT PVT NONE Amox 1
0164874 01/18/2001 ID 45.0 45 F 12/20/2000 Patient developed left arm and shoulder pain. U 12/19/2000 12/19/2000 0 OTH PVT NONE NONE NONE ID00056 1
0164875 01/18/2001 CA 31.0 31 M 01/02/2001 Patient started feeling dizzy and sick. While caretaker was trying to get him into the car, he had a seizure and wet himself. He recovered from the seizure. Patient was diagnosed with vaccine flu reaction, questionable seizure and vasovagal syncope. Y Y 12/28/2000 12/28/2000 0 PVT UNK NONE History of mental retardation and expressive language disorder 1
0164876 01/18/2001 WI 85.0 85 F 12/28/2000 On the day after receiving vaccine, patient developed symptoms similar to those she had years ago when she had an allergic reaction to PNC. Her symptoms included bilateral lower leg pain and weakness. By the time she visited her doctor two days later, she was wheelchair bound and remained in this weakened state for about 1 week. Her legs are still a bit weak, but she exercises them daily and has no permanent problems. Y 10/09/2000 10/10/2000 1 Serum sickness test PUB PUB Vioxx, Tenormin, HRT, Claritin-D, Procardia NONE Chronic lung, cardiac and arthritis problems. Also many allergies including PNC, morphine, codeine and Lomotil WI0102 1
0164878 01/18/2001 MT 49.0 49 M 01/10/2001 Patient noted 20-30 flat, non-raised, red blotches on his chest, back, and legs approximately 24 hours after receiving vaccine. The spots were about 1/2 the size of a dime. Patient also reported periods of slight lightheadedness. Y 01/09/2001 01/10/2001 1 NONE OTH PUB Occasionally uses an inhaler prior to exercise A RESOLVING COLD Mild asthma, allergic to penicillin 1
0164879 01/18/2001 MT 53.0 53 M 01/11/2001 Patient developed nausea and vomiting, weakness, tightness in throat, and itchy hives all over his body approximately 1.5 hours after receiving vaccine. He took 7-Up for his nausea. Patient called his doctor on 12/21/00 and was told if the hives persisted on 12/22/00 then he should call the doctor again. Patient stated the hives were gone as of 12/22/00. Y 12/19/2000 12/19/2000 0 NONE OTH PUB NONE Left arm weakness 1
0164880 01/18/2001 CA 71.0 71 F 01/09/2001 This patient had swelling and pain in her left deltoid. U 01/09/2001 01/09/2001 0 NONE PVT PVT NONE 1
0164881 01/18/2001 IL 3.0 3 F 01/09/2001 This patient had an indurated erythematous swelling on his left arm at the site of injection. Y 01/04/2001 01/08/2001 4 NONE PVT PVT Swelling, fever, itching 1
0164882 01/18/2001 MI 1.08 1 .0 F 01/12/2001 This child had generalized papular rash over entire body (torso, arm, legs, face) occurred 5-7 days post injection. The child was taken to Med-Express. Treatment given was one dose of steroids, the mother stated decrease in symptoms. 2-3 days increased symptoms; the child was taken to ER and treated with steroids for a week. Y 09/06/2000 09/11/2000 5 PUB PUB NONE NONE NONE 1
0164883 01/18/2001 OK 1.0 1 .0 F 01/09/2001 This infant had redness, and swelling approximately the size of a nickle. The doctor ordered Benadryl and the patient responded well to it. The swelling started to go down after 15 minutes. Y 01/09/2001 01/09/2001 0 MIL MIL NONE NONE NONE 1
0164884 01/18/2001 NM 49.0 49 F This patient had headaches, extreme fatigue, inability to concentrate, immune impairment (continuing ten weeks later). N 10/26/2000 10/26/2000 0 PVT PVT NONE NONE 1
0164885 01/18/2001 OR 1.0 0 1 F 01/08/2001 This child had a fever of 103 on 07/07/98. A temperature of 105 - 106 rectal at home on 07/08/98. A temperature of 103 axillary in office on 07/09/98, bilateral otitis media ; treated with Acetaminiphen, Ibuprofen, Trimethoprim / Sulfa antibiotic; Nystatin oral suspension for thrush. On 07/10 Cefirraxone IM. The patient had viral exanthem rash from 07/11 to 07/15 pink, macular, irritable. The patient is now irritable, delayed, and has autistic features. Y Y 07/06/1998 07/07/1998 1 07/10/98 Urinalysis - Neg, Culture - Neg, Blood Culture - Neg, WBC- 4,300 and other lab test. PVT PVT NONE NONE Twin A (fraternal) 1
0164886 01/18/2001 MI 0.2 0 .2 M 01/10/2001 Approximately 2 hours after this infant had his vaccines, the child had redness at the site of injection on his left leg (0 contraindication). the infant had inconsolable crying for 2 hours. The parent put ice on site and the infant continued crying. The infant has no history of crying for a long period of time or any other problem. Y 10/06/2000 10/06/2000 0 PUB PUB NONE NONE 1
0164887 01/18/2001 WI 5.0 5 M 11/10/2000 This patient's father reports onset of fever between 10 AM - 11 AM this morning. He also reports vomiting 3 times, fatigue, malaise, and a stomach ache. The patient temperature was not measured. The nurse consulted the physician and advised the family to monitor his sickness. Seek medical care if fever increases of sickness continues or worsens. Y 11/09/2000 11/10/2000 1 NONE PUB PUB NONE NONE WI0105 1
0164888 01/18/2001 WI 11.0 11 F 11/16/2000 One minute after the vaccine was given to this patient, she lost consciousness for 5 seconds, involuntary clonic tonic movements of arms and legs, her eyes rolled back and fluttering. Inhalation and exhalation throughout. Skin moist and warm face and trunk. Hands moist and cool, lips pink. No paleness and memory of what happened, no history of seizure disorder. Y 11/14/2000 11/14/2000 0 PUB PUB WI0026 1
0164889 01/18/2001 WI 0.5 0 .5 F 11/15/2000 The mother of this patient was concerned about the persistant swelling at the site of injection on 10/30/00. Swelling noted the day after immunizations received. The mother feels it has gotten "larger", firm, moveable swelling (4cm x 4cm) anterolateral aspect left thigh. No erythema, no tenderness, full range of motion, no medical evaluation sought to date. Y 10/30/2000 10/31/2000 1 PUB PUB NONE NONE WI0101 1
0164890 01/18/2001 WI 8.0 8 F 01/04/2001 The father reports a 3" long x 4" wide area where vaccine was given to be red, swollen, hard to the touch, and warm. Advised to contact health department. Recommended ibuprofen and ice. Y 01/03/2001 01/03/2001 0 NONE PUB PUB NONE NONE WI0103 1
0164892 01/18/2001 CA 12.0 12 M 01/02/2001 The pt experienced vomiting, abdominal pain. Mother states "never ever vomits". Y 01/02/2001 01/02/2001 0 NONE PUB PUB NONE NONE CA010001 1
0164893 01/18/2001 CA 0.4 0 .4 U 01/04/2001 The pt experienced a fever of 104.4 for 2 days with Tylenol, went to ER and told to use "tepid baths"; unconsolable crying for 2 days and then "became well". Follow up: According to MA who filled out the form, adverse event onset is unknown. Y Y 09/06/2000 NONE PVT PUB NONE NONE NONE CA000158 1
0164894 01/18/2001 CA 58.0 58 F 12/08/2000 The pt experienced pruritis, allergic dermatitis at the site of injection (left deltoid) with redness and itching. U 12/01/2000 12/01/2000 0 PUB PUB CA000159 1
0164895 01/18/2001 CA 44.0 44 M 12/20/2000 The pt experienced allergic dermatitis at the site of injection with redness and fever. U 12/18/2000 12/19/2000 1 PUB PUB CA000160 1
0164896 01/18/2001 UT 52.0 52 F 01/06/2001 Approximately 1/2 hour post vax. the pt started experiencing tingling around her mouth, face then turned red and started itching, tingling went to the arms and continued off and on for about a week. Pain in the hand and feet started the following day. N 12/22/2000 12/22/2000 0 NONE PVT UNK NONE allergy to PCN, erythromycin, sulfa 1
0164897 01/18/2001 TX 4.0 4 M The child became rigid, stared into space and did not respond to verbal stimuli for about 2-3 seconds. Child responded as soon as placed in supine position. Y 01/10/2001 01/10/2001 0 NONE PUB PUB NONE NONE NONE 1
0164898 01/18/2001 MN 1.0 1 .4 F 01/08/2001 The pt experienced redness at the injection site beginning the evening of the vax. Increased redness over the next 48 hours to 12 x 12 cm, was warm and swollen. Fever to 101.0 for 2 days. Y Y 01/02/2001 01/02/2001 0 NONE PVT PVT NONE NONE NONE 1
0164899 01/18/2001 NJ 0.2 0 .1 F 01/12/2001 The pt experienced a rash. Petechiae was noted. Platelets were less than 1,000. Bone marrow consistent with ITP. Admitted of IVIG. Y Y 12/22/2000 01/11/2001 20 PVT PUB NONE NONE premature birth 1
0164900 01/18/2001 MD 8.0 8 M 01/11/2001 Approximately 10 minutes post vax, the pt was in the car and began clenching teeth, arm flexing, non-responsive for approximately 20 seconds. Then immediately became responsive and alert. Complained of feeling dizzy, and lightheaded. Examined within 10 minutes and had normal exam including vital signs and neurologic exam. Y Y 01/09/2001 01/09/2001 0 NONE PVT PVT NONE NONE NONE 1
0164901 01/18/2001 DC 1.4 1 .4 F 01/05/2001 24 hours post vax, the pt experienced swelling, erythema, warmth and induration was noted at the injection site, erythema 6cm x 13 cm. Non-tender, induration approximately 1 cm in diameter. Area affected is the left thigh. Y U 01/03/2001 01/04/2001 1 PVT PUB NONE NONE 1
0164902 01/18/2001 NY 1.0 1 .0 F 01/10/2001 On 12/28/00 at 4:30AM to 12/30/00 9:00am the pt experienced a fever of up to 104-105 with Tylenol every 4 hours. The fever would drop to 102 but then spike back up to 104/105. On 12/30/00 at 9:00 am to 12/30/00 8:00pm the pt experienced a fever of 102, treated with Tylenol. On 12/29/00 the skin around the eyes were red and eyes were watery. On 12/30/00 at 6:00pm the pt had a head to toe rash - red dots, some raised and most hot. No discomfort was noted with rash. Y Y 12/21/2000 12/28/2000 7 all tests - nml PVT PVT Amoxicillin, ear infection hip dysplasia 1
0164903 01/18/2001 CA 31.0 31 F 01/11/2001 The pt experienced a severe pruritic maculo-papular rash for 1 week. Started on trunk and proximal extremities spread distally to involve entire body except palms and soles and face. Minimal relief with antihistamines or topical steroids. Y 10/10/2000 10/11/2000 1 NONE PVT OTH prenatal vitamins NONE carrier of hepatitis b 1
0164904 01/18/2001 TN 4.0 4 F 01/09/2001 10 minutes post vax, the pt complained of stomach hurting then a couple of minutes later the child's eyes rolled back in head and the child passed out. Y 07/07/2000 07/07/2000 0 NONE PVT OTH NONE NONE NONE 1
0164905 01/18/2001 MN 6.0 1 .9 M 01/08/2001 The pt experienced chicken pox on 1/1/01 through 1/10/01. Y 12/19/1995 12/26/2000 1834 PVT UNK 1
0164906 01/18/2001 OH 13.0 13 F 01/12/2001 Exactly one week posit vax, the pt experienced hives covering the entire body lasting 2-3 days. Y Y 12/13/2000 12/20/2000 7 PVT UNK Insulin diabetic 1
0164907 01/18/2001 CA 2.0 2 .2 M 01/11/2001 The pt experienced swelling, redness. No fever was noted. At an evaluation the following day, the right thigh was warm, erythematous with marked swelling of entire right thigh. Parent applied compresses with com improvement. The pt took Benadryl. Y Y 01/02/2001 01/02/2001 0 NONE PUB PUB NONE NONE NONE 1
0164908 01/18/2001 MT 42.0 43 F 01/11/2001 The morning after the vax, the pt felt ill when she went to work. She felt progressively worse until she left work early. She had an itchy sore throat, chills, headache, nausea and generalized joint soreness. The pt also states that some of her co-workers have missed work due to illness recently. Y 01/10/2001 01/11/2001 1 NONE PUB PUB multi vitamin NONE NONE 1
0164909 01/18/2001 CO 1.9 1 .8 M 12/29/2000 The same day as vax, the pt experienced hives and was sick. He experienced one episode of vomiting, and appeared a little clingy. He was treated with Benadryl with some relief. He was referred to a clinic. Y Y 11/16/2000 11/16/2000 0 PUB PUB NONE NONE CO0029 1
0164911 01/18/2001 CA 25.0 25 F 01/12/2001 The pt experienced a rash and itchiness. Rash was noted on arms, legs, chest and some of the abdominal areas. Pt complained of itching. Treated with Benadryl and hydrocortisone cream for itching. Y 01/05/2001 01/05/2001 0 NONE PUB PUB NONE NONE 1
0164912 01/18/2001 TX 11.0 11 M 01/12/2001 The pt experienced a 6.5 x 2 cm erythemic, tender, macular area to the left deltoid. U 01/09/2001 01/10/2001 1 PVT PVT NONE NONE 1
0164913 01/18/2001 PA 1.2 1 .2 M 01/16/2001 The pt experienced a seizure like episode after the vax was given. Y Y 01/15/2001 01/16/2001 1 PVT PVT Tylenol URI 1
0165143 01/18/2001 CO 51.0 51 F 11/17/2000 Before leaving the doctors office, the pt told the clerk that her chest felt tight and the clerk notified the RN. The pt stated that the tightening occurred suddenly. They loosened clothing and had the pt lie down. The tightness continued and her throat began to feel numb. Her color remained pink. 911 was called. Treated with epinephrine and transported to the hospital. Y Y 11/13/2000 11/13/2000 0 P-96, BP 162/92 PUB PUB Serevent, Flovent, Albuterol, Verapamil, Flexeril NONE allergies CO0024 1
0164914 01/19/2001 CT 0.2 0 .2 M 01/17/2001 A call was received from a medical examiner stating the child had died of SIDS on 1/12/01. Autopsy states pulmonary congestion and edema. Final cause of death given as sudden death associated with bronchopulmonary dysplasia. Y 01/12/2001 N 01/10/2001 01/12/2001 2 PVT PUB Synagis BPD History of BPD, on nasal O2 and home monitor. Premature at 31 weeks gestation. CT200101 1
0164915 01/19/2001 AZ 27.0 27 F 01/10/2000 The pt experienced a high fever of 104 for 2 hours following vax. Severe joint pain and headache. Joint pain has continued over the past eight years worsening 3 years ago. This has been reported to a doctor but no treatment has been recommended. 60 day follow-up states the pt continues to get worse every year. Y N 01/10/1992 01/10/1992 0 PUB PVT 1
0164916 01/19/2001 CA 38.0 38 M 01/17/2001 Pt developed Guillain-Barre' Syndrome approx. 6 weeks, post vax. He received plasma-phoresis. He has developed Bell's Palsy which began about 1/3/01. He has some paralysis in progress. Per F/U 6/19/01: Pt speech is thick and he has dizziness. He awoke with numbness to bilateral fingers, mouth and slowly progressing now to bilateral feet, too. He also has double vision. He has no reflexes on all 4 extremities. Seen earlier that day for same symptoms but is progressively worsening. 800mg Motrin/ibuprofen. Addendum: Did not have flu vaccine this year (historically, some reports of association of GBS with anticedent vaccinations); would not give flu vaccine at this point. Hospitalized. He has ataxia. Palate paralysis with nasal voice (hoarseness) ; has swallowing difficulty and respiratory insufficiency. Follow-up with Neurology and speech pathology. Follow up on 06/19/2001: "Patient has had a history of cough for about a week and had an episode of diarrhea last week prior to admisison. Chronic illnesses before onset of GBS: 2.5 years ago had back surgery 2* to pain in left leg. Ruptured disc. Another time patient received influenza was two years ago." Y Y Y 10 Y 11/16/2000 12/23/2000 37 Per F/U 6/19/01: BP-151/88; PR-106; RR-20; LP-unsuccessful; 2nd LP-no CSF obtained; CBC; CT scan PVT PVT work related eye injury; Per F/U 6/19/01: cough X 3 weeks and violent diarrhea 1998 L4-L5 disc surgery 1
0164917 01/19/2001 MD 60.0 60 F 01/11/2001 The pt experienced flu symptoms, shortness of breath, chest congestion, runny nose, constant cough, muscle aches etc. Still very sick. Y Y 2 N 01/05/2001 01/05/2001 0 PUB PVT NONE NONE NONE 1
0164918 01/19/2001 MD 32.0 32 F 01/09/2001 The evening of the vax, while lying down to sleep, the pt noticed itching on buttocks and feet were burning. The next day around 2:00 pm, the pt complained of feet were burning and parts of my skin all over my body was itching. She called the MD for advice. She was told to take 2 Benadryl and drink lots of water and to lay her feet on frozen bags with towels around them. The pt complied but still had itchy whelps and rashes that were huge. The follow day, the breakout began in different places on the body. The pt then experienced a swollen tongue. She called her MD, but was placed on hold for a long period of time and then decided to call an ambulance and was taken to the hospital. She was given steroids, after which the intense itching stopped. The pt then experienced boils between her legs where she sits. The boil turned into a huge abscess which had to be lanced and packed twice (different days) in which she received no medication to relieve the pain. The abscess covered a large area between her legs, about the size of a naval orange. The pain traumatized the pt. She has been a diabetic for about 2 years and has never experienced anything like this before. The pt has never had adverse reactions to vaccinations prior to this. The pt believes the flu shot was a large part of her pain because the smell of the abscess was like rotten eggs plus the MD who performed the lancing told her that the steroids would have produced the boil. In conclusion, the pt will never take the flu vaccine again. Y Y Y 12/15/2000 12/15/2000 0 PUB UNK Diabetes diabetes 1
0164919 01/19/2001 CA 1.0 1 .0 F 01/15/2001 5 minutes post vax, the pt developed hives in the right groin area and upper body with itching. Treated with Benadryl. The pt was observed for 15 minutes. Hives decreased and pt went home. Y 01/15/2001 01/15/2001 0 OTH PUB PPD, Pasteur, lot #C0519AA on 1/15/01 NONE 1
0164920 01/19/2001 NY 42.0 41 M 01/01/2001 The pt experienced swelling of fingers on both hands, fingers had red sore like spots. They itch and were very painful. Y N 10/19/1999 PVT PVT 1
0164921 01/19/2001 TX 0.5 0 .5 M 01/10/2001 The pt was unable to sleep and developed diarrhea. No treatment was given. Y 10/16/2000 10/16/2000 0 PVT PVT NONE 1
0164922 01/19/2001 1.08 1 .0 M 01/05/2001 The pt experienced a knot with redness one day post vax. The pt also experienced a 3cm area of induration. The pt developed redness to the anterior right thigh. The pt also had a rash behind the neck. Was seen in clinic on 2nd day. Y U 01/03/2001 01/04/2001 1 MIL MIL NONE NONE 1
0164923 01/19/2001 NH 0.5 0 .5 M 01/10/2001 The pt experienced a fever of 104 and was fussy. Symptoms resolved the following day. Y 01/08/2001 01/09/2001 1 NONE PVT PUB NONE NONE NONE NH0101 1
0164924 01/19/2001 CA 36.0 34 M 01/12/2001 On 6/25/99 following vax, the pt had a sore arm. On 7/9/99 following 2nd dose the pt experienced soreness in arm again. On 7/23/99 following 3rd dose the pt experienced blood in the stool. On 1/28/00 following dose 4, the pt experienced hives all over the body, continuous dryness of skin, blood in stool and low immune system. Blood in stool, drynes of skin, rash, low immune system. Stopped the vaccination of the Anthrax shot. Broke out in hives. N 07/23/1999 07/24/1999 1 WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, Platelet, MPV, MONO, NEUT, EOS, BASO - all wnl, LYMPH - 53.0 elevated MIL MIL blood in stool and hives hayfever soreness and fever~Anthrax (no brand name)~1~34.00~In Patient 1
0164925 01/19/2001 TX 1.0 1 .0 F 01/09/2001 The pt experienced a localized reaction to the right thigh injection site. The site was slightly red, swollen, and warm to the touch. U 12/27/2000 12/28/2000 1 PVT UNK NONE None 1
0164926 01/19/2001 MS 36.0 36 F 01/11/2001 Shortly after vax the pt felt lightheaded, became pale and nearly fainted. She sat in a chair with her head between knees for about 10 minutes then went back to work. A couple hours later it was reported that she felt much better and that it had happened last year when she got her flu shot. She also stated she was having joint pain and swelling in her right hand and could hardly use it. She stated she could bare get up and down from sitting and had difficulty walking. It was advised that she doesn't take the vaccine again. Y 11/21/2000 11/21/2000 0 NONE PVT PVT 1
0164928 01/19/2001 WY 67.0 67 F 24 hours post vax the pt noticed a ver foul odor much like rotten eggs. Nothing would eradicate this nauseating odor 24 hours a day. After 24 more hours the pt experienced a severe headache and general muscle aches. These symptoms lasted about 2 weeks. The pt had a reoccurrence of the foul odor occasionally for 1 month following the vax. Y Y 11/20/2000 11/21/2000 1 PUB UNK 1
0164929 01/19/2001 PA 59.0 59 F 12/22/2000 One day post vax, the pt started itching which lasted most of the day. It itched like dry skin, the pt used lotion. The next day, the pt woke up with itching with hives on the buttocks, sides and back, abdomen and top of legs and waist line. Ears were hot and swollen. Took Benadryl. Hives lightened. Was taken to the ER. Y Y 12/20/2000 12/21/2000 1 OTH PUB Proventil inhaler, Prempro, Celebrex passed out at work PA0113 1
0164930 01/19/2001 PA 64.0 64 F 12/12/2000 The pt experienced a blotchy raised rash on chest only, with itchiness. It was irritated by clothing. No respiratory symptoms. The rash faded but did not disappear. It reoccurred on 11/26/00. The pt took Benadryl for some relief. On 12/11 the rash faded. Y 11/17/2000 11/18/2000 1 PVT PVT PA0112 1
0164931 01/19/2001 PA 77.0 77 M 11/30/2000 The pt complained of pain in his neck approximately 20 minutes post vax as he was getting into his car. 24 hours later he still experienced pain associated with movement of his head. Has had similar pain in the past, but not this bad. U 11/29/2000 11/29/2000 0 PUB PUB Allegra NONE NONE PA0111 1
0164932 01/19/2001 MO 4.0 4 M 01/08/2001 The pt experienced 8-10 episodes of blinking eyes and upward eyebrow movements without loss of consciousness without staring and without loss of continence. U 01/04/2001 01/05/2001 1 PVT PUB chronic middle ear infection with bilateral tube placement blinking eye movements~Influenza (Seasonal) (no brand name)~1~3.50~In Patient 1
0164933 01/19/2001 MI 24.0 24 F 01/03/2001 5 minutes following vax while driving, the pt felt a hot burning sensation go up her arm ant hen throughout her whole body. The pt complained of a loss of peripheral vision. When getting out of her car she became dizzy and nauseated and began stumbling. The pt went to the ER by ambulance. The pt was diagnosed with an adverse flu shot reaction. No further problems as of this date. Y Y 12/21/2000 12/21/2000 0 NONE PUB PUB Birth control pills, Paxil NONE NONE 1
0164934 01/19/2001 ME 17.0 17 M 01/16/2001 The pt complained of neck pain one day post vax. The pt went to the ER. MD wasn't sure if reaction was related to the vaccine. No redness at the site of injection was noted. Y U 01/11/2001 01/12/2001 1 PUB OTH ME01001 1
0164935 01/19/2001 MA 6.0 1 .6 F 01/17/2001 The pt experienced scattered vesicles and papules on chest, arms and forehead. Itching that lasted for 2 days. Y 12/27/1995 01/06/2001 1837 PVT PUB 1
0164936 01/19/2001 WV 1.0 1 .0 M 01/11/2001 On 1/9/01 the pt experienced a knot in neck. On 1/11/01 a rash was experienced on back and on the abdomen. The pt was afebrile. Y Y 01/02/2001 01/09/2001 7 PUB PUB NONE WV0201 1
0164937 01/19/2001 NC 0.2 0 .2 F 01/09/2001 The mom states the baby cried non-stop for 2 hours from 7:00 pm - 9:00 pm on the day of vaccine. Y 11/07/2000 11/07/2000 0 PVT PUB NONE NONE 1
0164938 01/19/2001 NM 1.5 1 .6 F 01/05/2001 The pt experienced cellulitis to the right deltoid with redness, induration and warmth to the touch. It was initially treated with ice, ibuprofen and Benadryl. Keflex was prescribed but never given. By 12/31/00 the pt's symptoms had resolved. Y Y 12/27/2000 12/28/2000 1 NONE PVT PUB NONE NONE congenital transposition of great vessels 1
0164939 01/19/2001 PA 1.0 1 .1 M 01/15/2001 On 1/7/01 the pt had a fever of 102, trouble breathing, ataxia. Was seen by a doctor at 1/11/01. Fever has resolved. The pt was still slightly ataxic, no stagmus. Y Y 01/04/2001 01/07/2001 3 NONE PVT PUB NONE viral gastroenteritis NONE 1
0164940 01/19/2001 CO 54.0 54 M 12/05/2000 The pt states that he has an ache in left deltoid muscle area when he stretches arm back (similar to motion of putting on coat). Noted this within 1st week after shot and it has remained since. Believed this is slightly worse. Can lift hay bales without discomfort, but it hurts to sleep on that arm. No heat, redness or swelling. Y N 11/06/2000 11/13/2000 7 PUB PUB NONE hx of animal bite CO0027 1
0164942 01/19/2001 PA 12.0 12 M 11/08/2000 The pt experienced itching all over body, mother applied calamine lotion. Y 10/18/2000 10/19/2000 1 PUB PUB NONE nasal and chest congestion pos sickle cell, high lead PA0101 1
0164943 01/19/2001 PA 8.0 8 M 11/08/2000 The pt experienced itching all over the body. Mother applied calamine lotion. U 10/18/2000 10/19/2000 1 PUB PUB NONE cold symptoms high lead, sickle traits PA0102 1
0164944 01/19/2001 PA 50.0 50 F 12/05/2000 1 hour post vax, the pt experienced hives from head to toe, mostly on trunk. The pt also experienced swollen eyelids the next day. The hives lasted 1.5 weeks. Y 08/31/2000 08/31/2000 0 NONE PVT PVT NONE NONE allergy to ASA PA0107 1
0164945 01/19/2001 PA 15.0 15 M 11/30/2000 The pt received the vaccines at 9:00 am. at 9:40 the pt experienced an anaphylactic reaction. upper eye lid edema and facial hives, nasal congestion. Treated with epinephrine and chlortrimeton. Y 11/29/2000 11/29/2000 0 OTH PUB allergy to seafood PA0108 1
0164946 01/19/2001 PA 10.0 14 M 11/28/2000 Approximately 6 months post vax, the pt's lips became swollen and his chin turned cyanotic. The pt was taken to the ER and given Benadryl and held for observation. Swelling reduced the following day, but the chin appeared bruised. MD thought it was a reaction to one of the vaccines. Y Y 11/14/2000 11/14/2000 0 PUB PUB NONE NONE NONE PA0109 1
0164947 01/19/2001 PA 1.2 1 .1 M 11/28/2000 The child received the vax on 10/2/00. Returned to the clinic on 11/27/00. Mother said 1 week after the vaccine the child had a rash and fever of 103.9 axillary. Mother notified the physician. The child was treated with Tylenol and the fever began to come down. Y 10/02/2000 10/19/2000 17 PUB PUB NONE NONE NONE PA0110 1
0164948 01/19/2001 PA 12.0 12 F 12/18/2000 The pt was seen in the ER on 11/7/00 at 11:32am, complaining of left arm pain, tingling and numbness. Treated with Advil/Motrin. Y Y 11/06/2000 11/07/2000 1 PUB PUB NONE NONE PA0114 1
0164949 01/19/2001 PA 5.0 0 .5 F 12/15/2000 The pt experienced a fever of 102, and was given Tylenol. Fever decreased to 101 and then increased back to 104. Y Y 12/14/2000 12/15/2000 1 CBC OTH UNK runny nose NONE PA0115 1
0164950 01/19/2001 IL 0.44 0 .4 M 01/04/2001 A mother reported that the child has a rash on abdomen, arms and legs, was fussy. The pt had a temp of 99.6, raised lump at left leg injection site. The pt is eating ok. On 1/5/01 the mother reports that the rash has improved and the lump on left thigh is smaller and the pt is less fussy. Y 01/03/2001 01/04/2001 1 PUB PUB NONE NONE 1
0164951 01/19/2001 OR 1.5 1 .5 M The pt experienced a 6 x 4 inch induration, no discharge. (Enlarged leg syndrome.) U 01/03/2001 01/03/2001 0 NONE PVT PVT NONE NONE NONE 1
0164952 01/19/2001 NY 52.0 52 M 01/10/2001 Within 24 hours the pt developed a 10 cm area of erythema, edema and tenderness at the injection site. Mild Arthus-type hypersensitivity was diagnosed. 8 weeks later developed a mild reoccurrence and shooting pains at the site. Resolved with symptomatic therapy. Y Y 09/29/2000 09/30/2000 1 x-ray of site - neg PVT OTH pain hip diabetes 1
0164953 01/19/2001 GU 20.0 20 F 01/04/2001 About 12 hours post vax, the pt complained of tongue and throat swelling and states it felt like it was all numb. She states she could hardly breath or swallow. She took an Atarax pill and it helped but her tongue and mouth are still numb. Y 01/03/2001 01/03/2001 0 NONE MIL MIL Ortho Novum, Midrin mild cold allergy to morphine, codeine, PCN, sulfa 1
0164954 01/19/2001 MN 12.0 12 M 01/10/2001 The pt experienced swelling of the face 1 day post vax. Returned to the clinic and was placed on Prednisone, but swelling increased. Presented to the ER 2 days post vax and treated with Benadryl. Y Y 08/04/2000 08/05/2000 1 NONE PVT PVT Zoloft NONE depression 1
0164955 01/22/2001 20.0 M 01/15/2001 In 4/90, 11 days post vax, the pt experienced recurrent focal seizures. At the time his HIV infection was diagnosed in 10/85, blood analysis consistently revealed leukopenia, mild thrombocytopenia and hemoglobin concentrations of 11.2 to 13.6, lymphocyte counts were around 200-300, CD4 to CD8 ratios of 0.2-0.47. In 10/89, therapy with zidovudine was initiated. The pt had no symptoms related to HIV infection or zidovudine therapy. Although he had received the measles vaccine in 1973 at the age of 3 and a dose of MMR in 1976 at the age of 7, the pt was admitted to the hospital for three days in 2/90 with uncomplicated measles. Tachypnea and respiratory distress responded promptly to therapy with oxygen and aerosolized ribavirin. The pt responded well until two months later, when he presented after two days of recurrent right arm twitches without fever. Physical exam revealed only continuous fine twitches of th right arm. CSF analysis and computed tomography of the head gave normal results, electroencephalography, however, showed right frontal slowing with spike discharges centrally, persisted despite therapeutic anticonvulsant concentrations in serum. the pt was admitted 11 days after the onset of seizures for further diagnostic evaluation. At the time of admission, he was conscious and afebrile. He had right-arm and right-leg twitching but was able to walk. His mental status and the results of motor and sensory examination were normal. Although the latter condition responded to the fluid restriction, the pt developed slurred speech and gradually became unresponsive requiring endotracheal intubation. A 10 day course of IV therapy was given. The pt remained comatose, experiencing continuous focal seizures that could not be controlled with anticonvulsant agents. Neurological and electroencepahlographic exam on day 24 of hospitalization indicated brain death. Mechanical ventilation was discontinued on day 30. The cause of death was subacute measles encephalitis. Y Y N 02/01/1990 CSF and CT of head-were nml; EEG-showed right frontal slowing with spike discharges centrally; CBC-nml; CXR-nml; lab-showed evidence of the syndrome of inappropriate secretion of adrenocorticotropic hormone was found; Titers of measles antibody at this time were undetectable; autopsy-the brain weighed 1.540 g (expected weight, 1.350 g) and its gross characteristics were nml; Focal acute neuronal necrosis was evident in the dentate nucleus UNK UNK hemophilia A, HIV Hemophilia A; human immunodeficiency virus infection WAES01010267 1
0164956 01/22/2001 FL 1.08 1 .1 F 01/12/2001 Child started with severe diarrhea and loss of appetite, 24 hours, post vax. Called pediatrician and child admitted to hospital on 1/13/01. Telephone call to mom (does not speak English). Information obtained through interpreter; on 1/12/01, had 1 stool. This AM, appetite remains poor. Y 1 U 01/08/2001 01/09/2001 1 PUB PUB IPV by Connaught given also on 1/8/01 with a lot number of R1490 NONE NONE 1
0164957 01/22/2001 IL 1.75 1 .7 F 01/18/2001 Limping and dragging left leg, started right after vaccine given on 12/29/2000. No swelling noted. Admitted to orthopedics. Informed that dx: fluid in hip ; dx was septic arthritis L hip. On 1/14/2001, arthrotomy and drainage done. Per F/U 3/27/01: treated with cephalexin and ASA. Y 5 U 12/29/2000 12/29/2000 0 MRI-hip; CBC; ESR; cultures were neg; Per F/U 3/27/01: PT-136 PVT PVT NONE NONE febrile seizures 1
0164958 01/22/2001 CA 38.0 38 M 01/18/2001 Approximately 6 weeks post vax, the pt developed Guillain [[name]] Syndrome. The pt was hospitalized on 1/3/00 for about 7 to 10 days. The pt now has Bell's Palsy. Further information has been requested. A 15-day follow up report received 02/14/2001 adds: It was reported that a male pt received a Tetanus Toxoid Adsorbed vaccination on 11/16/2000. Approx 6 weeks after vaccination the pt developed Gillain [[name]] Syndrome. Pt was hospitalized on 01/03/2000 for about 7 to 10 days. Pt now has Bell's Palsy. Further info requested. From follow-up correspondence received on 02/07/2001, it was reported the pt received plasma phoresis. Pt has developed Bell's Palsy, which began about 01/03/2001. Pt had some paralysis that has resolved. Reportedly the pt's recovery is in progress. Y Y Y 7 Y 11/16/2000 12/30/2000 44 UNK PVT PVT Work related eye injury U200100100(1) 1
0164959 01/22/2001 CA 0.2 0 .2 M 01/17/2001 Sometime after the vaccinations the pt experienced seizures and strokes. The pt is currently hospitalized with intracranial bleeding and retinal bleeding. No specifics were provided. Further information is being requested. Follow-up received on 3/1/01 noted "No problems until 11/00" by MD. Additional info regarding pt, vaccine administrator, responsible physician, reporter, date of vax and vaccines given were provided. As you know, the pt was hospitalized for a reported acute head injury on 12/29/00 and I first examined him and followed his medical care there for a little more than a week or so. I have interviewed and spoken with the parents on numerous occasions since and seen and examined the pt several times. I have reviewed all tests and exams and an exhaustive medical evaluation is now complete. After many MRI's and exams, the mother disclosed that the infant had fallen off of a couch. The baby was discharged on low-dose baby aspirin (1/4), Zantac and seizure free on phenobarbital to be mixed into 2 bottles per day. The type of stroke injury seen on the scans is 'non-hemorrhagic' or ischemic. After the fall, the pt was unresponsive and EMS was called. In PICU the areas of pre-existing permanent brain damage were again seen in the pt's brain, but also a large right subdural hematoma and bilateral retinal hemorrhages were first discovered. These were not present in November. A new skeletal survey was still nml. The pt required neurosurgery on 1/2/01, to release the pressure on his brain. At surgery, the right subdural was seen to be made of blood, fluid and membranes, which is in agreement with the CT scans prior to surgery that documented new, subacute and older blood in the right subdural. This subdural hemorrhage(s) of various ages likely explains the history of intermittent vomiting during the 10 or so days prior to 12/29/00, which then became accompanied by recurrent seizures in spite of phenobarbital prior to the neurosurgery and the improvement in both the vomiting and the seizures after the subdural was evacuated. He has now been in foster care without known new events. This baby has suffered abusive head trauma or 'Shaken Baby Syndrome'. There were bilateral retinal hemorrhages and also a large retinal hemorrhage in the right macula that is usually seen in severe infant head trauma cases. A low-height fall from a couch to a carpeted floor cannot cause these and there is no other dx for this combination of medical findings than violent head trauma. I have considered aspirin as a complicating factor in the case. His PT and PTT were normal. While aspirin cannot be 100% ruled out as at least a contributor to continued bleeding after intial head trauma, it could have caused the subdural to become larger than it otherwise might have become, physical forces must have 1st injured the blood vessels to allow the blood to leak into the space in the 1st place. These same physical forces must also have caused the retinal hemorrhages at the back of both eyes and the same violent physical forces are certainly the cause of the retinoschisis. Y Y Y N 09/22/2000 11/06/2000 45 Head CT Scan; MRI X 2; MRA; Labs; Ophthalmologist exams X 3 MIL MIL NONE NONE U2001000740 1
0164960 01/22/2001 IL 66.0 F 01/17/2001 A territory representative reported that a 66 year old female received a 2nd dose of Pnu-Imune 23 on 111/28/00; she received a 1st dose on 4/10/98. That day, she developed a large area of cellulitis that extended from the injection site across her upper back. She was seen in the ER and admitted to the hospital. She was treated with IV antibiotics. She recovered. Y Y Y 11/28/2000 11/28/2000 0 UNK PVT OTH UNK UNK UNK HQ5454202JAN2001 1
0164961 01/22/2001 NY 0.3 0 .4 M 01/12/2001 The same day as the vax, the pt developed a maculo papular non pruritic rash on the abdominal with unconsolable crying lasting for 12-24 hours then he developed high pitched unconsolable crying lasting more than 3 hours. No treatment was given except acetaminophen. Y 01/09/2001 01/09/2001 0 NONE PVT PVT NONE NONE formula intolerance, gastroesophageal reflux 1
0164962 01/22/2001 UT 0.5 0 .5 F 01/12/2001 The pt experienced a convulsion (tonic) episode with post-ictal state. Y Y 01/11/2001 01/12/2001 1 NONE PVT PVT Zantac, Reglan NONE GERD 1
0164963 01/22/2001 VA 2.0 1 1 M 01/15/2001 On 1/11/01 at 5:30 PM the pt experienced a fever of 101. On 1/12/01 in the AM, the pt continued to have a fever. This continued through 1/13/01. Y 01/11/2001 01/11/2001 0 PVT PVT 1
0164964 01/22/2001 IA 1.0 1 .0 F 01/15/2001 The pt experienced a febrile seizure the same day of vaccination. Y Y 01/11/2001 01/11/2001 0 chest x-ray, CBC, blood cultures, urine culture PVT PVT NONE NONE NONE 1
0164965 01/22/2001 MN 0.75 0 .8 M 01/12/2001 The pt became febrile with a temp of 102 lasting over 24 hours after vax. The pt was also quite irritable and uncomfortable. No other symptoms were noted. Y U 01/11/2001 01/11/2001 0 NONE PVT PVT NONE allergy to Amoxicillin 1
0164966 01/22/2001 CA 20.0 20 F 01/09/2001 The pt experienced a headache within 15 minutes of vax. The pt also experienced weakness in arms, injection site sore (left more than right), muscle aches, dizziness, vomiting and nausea. Y 12/21/2000 12/21/2000 0 NONE PVT PVT NONE 1
0164967 01/22/2001 WI 25.0 24 M 01/11/2001 The pt developed a hoarse voice lasting about 12 hours, rash all over whole body, blotchy spots, noticed the next morning. Duration of 24 hours. Y 01/10/2001 01/11/2001 1 NONE OTH PVT NONE NONE 1
0164968 01/22/2001 PA 4.0 4 M 01/15/2001 The pt experienced severe pain in his right shoulder with swelling. 2 days later it had improved. No treatment needed. Y 01/10/2001 01/11/2001 1 NONE PVT UNK NONE asthma, chronic otitis media 1
0164969 01/22/2001 OH 68.0 68 F 01/10/2001 The pt experienced a swollen arm from shoulder to wrist. It was painful and then a day later turned red all over. Could not bend or reach with arm. Felt sick, had a fever and chills along with night sweats and coughing and some itching. Y Y 12/14/2000 12/14/2000 0 PVT UNK Zocor, synthroid, Rozimax NONE high cholesterol, hypothyroid 1
0164970 01/22/2001 NJ 16.0 16 F 01/12/2001 The pt presented to office 2 days post vax complaining of swelling and discomfort at injection site. Reaction to the right deltoid measured 3cm x 2 1/2 cm, was warm to the touch with erythema. Y U 01/08/2001 01/10/2001 2 NONE PUB OTH NONE NONE NONE 1
0164971 01/22/2001 VA 5.0 0 1 M 01/15/2001 The pt was diagnosed with varicella 4 years post vax. Y Y 12/27/1996 01/12/2001 1477 NONE PVT PVT NONE NONE 1
0164972 01/22/2001 NC 43.0 43 F 01/15/2001 The pt complained of a macular rash (papular) to trunk, upper arms and upper thighs. Clear nasal drainage, throat and tympanic membranes are clear, chest is clear, abdomen is soft, heart rats in regular with no murmur. Temp of 99.5, BP 130/90, P - 88, R - 20. Symptoms appeared on 12/15/00 and resolved pm 12/20 Y Y 12/01/2000 12/15/2000 14 viral syndrome PVT PUB Wellbutrin, Benadryl, Risperdal, Claritin, Synthroid NONE depression, hypothyroidism, seasonal allergies, drug addiction 1
0164973 01/22/2001 NY 33.0 33 F 01/16/2001 The pt called 24 hours post vax, with intense reaction to the right arm red with fever. After 48 hours the pain spread to her back, recommended Motrin for pain. On 1/11/01 the pt came to the doctor's office and right arm had blotches, advised to avoid DT vaccine. Y Y 01/08/2001 01/09/2001 1 PVT PVT allergy to PCN, sulfa drugs 1
0164974 01/22/2001 IL 3.0 3 F 01/02/2001 The pt received the vaccine on 12/21/00. On 12/30/00, a red area with a white spot at the injection site was noticed. It was approximately 1 1/2" long. U 12/21/2000 12/30/2000 9 PVT PUB NONE NONE NONE 1
0164975 01/22/2001 NY 24.0 24 F 01/20/2001 Following the yellow fever vaccine, the pt experienced pain in the vaccinated arm from underarm to the wrist. No redness, fever, or swelling. Did not see MD for this. On 1/5/01 reports the arm feels about the same, maybe slightly better. Still has not followed up with MD. U 12/27/2000 12/28/2000 1 PUB PUB NONE NONE 1
0164976 01/22/2001 NY 5.0 5 M 01/11/2001 On 1/2/01, one vesicle on the inner ankle was noted. The child complained of being cold and feeling tired. By the next morning the child had red, "pimply spots" on body. Had a fever for 2 days reaching 104.7. Child was covered with vesicles. Mother noted they didn't seem to itch as much as you might expect. All vesicles healed after 1 week. Treated for ear infection. Treated with Amoxicillin. Y Y 04/15/1999 01/02/2001 628 NONE PVT PVT Amoxicillin NONE NONE 1
0164977 01/22/2001 IA 48.0 48 F 01/08/2001 The pt experienced severe cold spells alternating with hot spells. Temp was not taken. Y 01/05/2001 01/06/2001 1 NONE PUB UNK NONE sinus infection 1
0164978 01/22/2001 MD 8.0 8 F 01/05/2001 Macular rash started on face within 18 seconds of administration of vaccines, spread over entire body; pruritus. Epinephrine 0.2cc administered, SC, with complete symptoms stop approx. 10-15 minutes after administration. Y 01/05/2001 01/05/2001 0 PUB PUB NONE NONE 1
0164980 01/22/2001 GA 0.5 0 .5 F 10/02/2000 A pediatrician reported that a 6 month old female received Prevnar on 09/21/2000. The physician reported that the mother stated the infant developed a fever of 99.9 to 100.5 F, fussiness, irritability, and difficulty sleeping on the day of immunization. On 09/23/00, the infant was seen in an emergency room after a 2-3 minute episode of "squeezing eyes shut, thrusting her head backwards, jerking, and rhythmic movements of her head". The reporter indicated that this infant experienced a seizure, however, she was "not post ictal" after the episode. Unspecified lab work and a CT scan were normal. On 09/26/00, the irritability resolved. This event is considered medically important. U 09/21/2000 09/23/2000 2 Computerized Tomogram - Nml. Unspecified lab work - Nml OTH OTH NONE NONE UNK HQ1538428SEP2000 1
0164981 01/22/2001 CA 2.0 1 1 M 11/21/2000 A parent reported that her 2 year old son received his first dose of Prevnar on 08/22/00. On 08/30/00, he experienced a seizure. Twenty-two days later, he experienced a second seizure. The seizure is considered a medically important event. The reporter stated that she submitted this report directly to VAERS. Follow up information was received from the child's neurologist on 11/14/00, who stated that an EEG was performed and that the results were "abnormal." U 08/22/2000 08/30/2000 8 Electroencephalogram - Abnormal PUB OTH NONE NONE UNK HQ1677202OCT2000 1
0164982 01/22/2001 TN 0.5 0 .5 F 01/10/2001 On 10/7/00 a blood culture was positive for Streptococcus pneumonia. Septicemia is considered "medically important". U 07/14/2000 10/07/2000 85 blood culture - pos for strep pneumonia PVT PVT NONE NONE UNK HQ2256116OCT2000 1
0164983 01/22/2001 NY 0.6 0 .6 F 11/09/2000 The same day of vaccination, the infant developed a fever and experienced a seizure. She was hospitalized where the reporter noted that the child was "sedated". Y U 11/06/2000 11/06/2000 0 UNK PVT OTH NONE NONE UNK HQ3376508NOV2000 1
0164985 01/22/2001 TN U 10/06/2000 Approximately 24-36 hours post vax, the parents observed that the infant no longer responded to noise. No further information was available at the date of this report. A copy of this report has been forwarded to Aventis Pasteur, manufacturer of IPOL. U 08/29/2000 08/30/2000 1 UNK PVT OTH UNK UNK UNK HQ0623005SEP2000 1
0164986 01/22/2001 NY 0.5 U 10/04/2000 Within 24 hours post vax, the pt became blue at the mouth and toes. The pt also developed a rash, vomiting, diarrhea and hives. The pt was seen in an urgent care center. A copy of this report has been forwarded to Aventis Pasteur, manufacturer of IPOL. Y U 08/29/2000 08/30/2000 1 UNK PVT OTH UNK UNK UNK HQ0623305SEP2000 1
0164987 01/22/2001 GA 3.0 3 F 12/19/2000 One week post vax, the pt developed a red, itchy rash on her lower body. Additional information indicates that the pt has sickle cell thalassemia disease. U 08/29/2000 09/05/2000 7 UNK PVT OTH Folic acid; PCN UNK Thalassaemia sickle cell red, itchy rash on lower body~Pneumo (Prevnar)~1~0.00~In Patient HQ0752407SEP2000 1
0164988 01/22/2001 GA 2.0 2 .7 F 12/20/2000 One week post vax, the pt developed a red, itchy rash on her lower body. U 04/29/2000 05/06/2000 7 UNK PVT OTH Folic acid; PCN (NOS) UNK Sickle cell disease (NOS) HQ0856111SEP2000 1
0164989 01/22/2001 FL U 09/14/2000 Subsequent to receiving Prevnar, DTaP, ActHIB and IPV, the pt screamed for 40 minutes. The reported indicated that the pt received the third dose of DTaP, ActHIB and IPV and did not have a reaction. The physician indicated that Prevnar was withheld. This is one of two pts from this facility who experienced screaming following vax administration. A copy of this report has been forwarded to Aventis Pasteur. U UNK OTH OTH NONE UNK UNK HQ0861211SEP2000 1
0164990 01/22/2001 MD 0.5 0 .6 F 12/14/2000 One day post vax, the pt developed redness on her chin, cheeks, and forehead. the reporter indicated the child was afebrile. A copy of this report has been forwarded to Aventis Pasteur. U 09/06/2000 09/07/2000 1 UNK PVT PVT NONE NONE UNK HQ0868111SEP2000 1
0164991 01/22/2001 PA 0.8 U 09/13/2000 Subsequent to receiving vax, the pt developed a fever. One day post vax, the pts fever rose to 103 degrees F. the pt also developed diarrhea, facial rash, and runny nose with a mild cough. U 09/06/2000 09/06/2000 0 UNK PVT OTH UNK UNK UNK HQ0904112SEP2000 1
0164992 01/22/2001 WI 0.75 0 .8 F 12/21/2000 Two weeks post vax, the pt developed a maculopapular rash that covered her entire body, including the soles of her feet and the palms of her hands. The rash improved after treatment with diphenhydramine. The reporter indicated that the pt has a family history of allergic reactions. U 08/25/2000 09/08/2000 14 UNK PVT PVT amoxicillin ear infection hypersensitivity (NOS) HQ0946713SEP2000 1
0164994 01/22/2001 FL U 09/14/2000 The reporter indicated that the pt experienced quite impressive screaming for an unknown duration post vax. This is one of two pts from this facility who experienced screaming following vax administration. A copy of this report has been forwarded to Aventis Pasteur manufacturer of to concomitantly administered vaccines. U UNK OTH OTH NONE UNK UNK HQ0971613SEP2000 1
0164995 01/22/2001 OH 0.3 1 .4 M 10/26/2000 Approximately 3 weeks post vax the pt was seen by a pediatrician who indicated that the infant had developed an urticarial type rash and increased temperature. A diagnosis of Henoch-Schonlein purpura was made. At the date of the office visit the infant experienced a 30 minute period of uncontrollable crying. Blood culture and CT performed on 09/07/2000 were negative. The infant recovered. A copy of this report has been forwarded to Aventis Pasteur, maker of the concomitantly administered vaccines. Y 08/16/2000 09/07/2000 22 09/07/2000 Computerized tomogram - negative; blood culture - negative PVT OTH NONE NONE UNK HQ1074915SEP2000 1
0164996 01/22/2001 IL 1.0 1 .0 F 12/21/2000 One day post vax the pt developed a fever. Approximately nine days post vax the pt developed a cold with cough. The pt was treated with Robitussin and recovered. A copy of this report has been forwarded to Merck, manufacturer of Varivax. Y 09/05/2000 09/06/2000 1 NONE PVT PVT NONE NONE UNK HQ1298721SEP2000 1
0164997 01/22/2001 NY 0.2 0 .2 M 10/16/2000 Subsequent to receiving vax, the pt developed lethargy, hypotonia and poor oral intake. He also became expressionless. U 06/20/2000 UNK PVT PVT NONE NONE UNK HQ1384825SEP2000 1
0164998 01/22/2001 NY 0.3 0 .4 M 10/16/2000 Subsequent to receiving vax, the pt developed hypotonia, lethargy and poor oral intake. The pt also became expressionless. U 08/31/2000 UNK PVT PVT NONE NONE UNK HQ1392325DEP2000 1
0164999 01/22/2001 NJ 0.9 0 1 M 10/26/2000 A physician reported that an 11 month old male received his 2nd dose of Prevnar on 9/22/00 and 24 hours, post vax, he developed diffuse redness on his left thigh, excoriated lesions on his hands and a generalized maculopapular rash. He was seen in the ER and prescribed hydroxyzine. Y U 09/22/2000 09/23/2000 1 UNK PVT PVT NONE NONE UNK HQ1546228SEP2000 1
0165000 01/22/2001 MI 0.75 0 .8 F 12/21/2000 A nurse reported that a 9 month old female received an injection of Prevnar on 3/29/00. On 3/30/00, she developed a fever and a "quarter-sized" welt at the injection site. The infant recovered. Y 03/29/2000 03/30/2000 1 UNK PVT OTH NONE NONE NONE HQ1606229SEP2000 1
0165001 01/22/2001 IN 0.25 0 .8 M 12/19/2000 A nurse reported that a 3 month old male received an injection of Prevnar on 9/11/00. Within 24 hours, post vax, he developed a generalized body rash, experienced lethargy and irritability. He recovered within the next 24 hours. Additional information received from the reporter on 10/30/00, stated that, post vax, the infant developed a fever greater than 101F. The reporter provided additional pt identifiers. The infant remained recovered. Y 09/11/2000 09/12/2000 1 NONE PVT OTH NONE NONE UNK HQ1608129SEP2000 1
0165002 01/22/2001 PA 1.3 1 .4 F 12/21/2000 A parent reported that her 17 month old daughter received her 1st dose of Prevnar, along with doses of DTAP and MMR II vaccines on 9/8/00. On 9/10/00, the child's mom reported that her daughter awoke screaming. She had developed a "bumpy rash" and experienced itchiness of her feet. A red rash developed on her back and hip. The child's mother indicated that since 9/10/00, her daughter has experienced restless sleep and continues to pound her feet. The mother stated that the rash resolved in 5 days; but reappeared all over her daughter's body. As of 9/28/00, the child's mother stated that her daughter's feet remain itchy. Additional information received from the child's physician on 10/27/00, stated that the child had been seen on 9/11/00 and again on 9/26/00. The child had been examined on both of these occasions by another physician who felt that the rash was eczema; "not a reaction to any vaccine." The physician stated that the child had been adopted from Russia on 8/27/00. Y U 09/08/2000 09/10/2000 2 NONE PVT PVT NONE Nasal congestion UNK HQ1684202OCT2000 1
0165003 01/22/2001 MA 0.3 0 .3 F A nurse reported that the mother of a 4 month old female called to report that her daughter who received Prevnar, HIB, DPT and IPV vaccines on 8/7/00, sounded hoarse, "like trying to clear her throat", 1 1/2 hours, post vax. She also developed a cough and "funny" wheeze. The pt was prescribed diphenhydramine. She recovered. On the date this report was received, the pt was seen by the physician and was described as "doing fine". The reporter questioned whether this event was an allergic reaction. Y 08/07/2000 08/07/2000 0 UNK PVT OTH Zantac UNK GERD HQ1844105OCT2000 1
0165004 01/22/2001 CO 0.5 0 .5 F 10/11/2000 A 6 month old female received her 1st dose of Prevnar on 10/2/00, as well as, her 3rd doses of Acel-Imune and IPV and 1 day later, developed a flat, papular rash on her face, trunk and diaper area. She was also "a little" fussy. She was seen in the physician's office and prescribed diphenhydramine. Y U 10/02/2000 10/03/2000 1 UNK PVT OTH NONE UNK UNK HQ1846605OCT2000 1
0165005 01/22/2001 MI 1.0 U 12/18/2000 A sales representative reported that a 12 month old received Prevnar, Varivax and Hep-B on 10/4/00 and the next day, developed "swollen eyes which were almost shut for a couple of hours". The reporter indicated that the child's mother has a history of allergies. Additional information received on 10/16/00, from the sales representative, included the Prevnar lot #. Additional information received on 10/23/00, indicated that the pt developed an injection site reaction, the evening of immunization characterized by a raised area of redness and warmth at the Prevnar injection site. The pt recovered. Y 10/04/2000 10/05/2000 1 UNK OTH OTH NONE NONE UNK HQ1962109OCT2000 1
0165006 01/22/2001 FL 1.5 1 .5 M 10/26/2000 A nurse reported that an 18 month old male received vaccinations on 9/26/00 and the next day, developed a fever of 100F and "cried when walking". He also developed an injection site reaction characterized by warmth and swelling at the site of Acel-Imune administration. The mother treated the child with Tylenol. On 9/28/00, the mother reported that the child slept restlessly and that the swelling now extended from the upper thigh to the knee. That same day, he was seen by the physician who noted that his "right knee appeared larger that his left knee" and that the fever, swelling and difficulty walking had resolved. He recovered. Y Y 09/26/2000 09/27/2000 1 NONE PVT PVT Amoxicillin Otitis Media Otitis Media NOS; Rhinitis NOS HQ1974109OCT2000 1
0165007 01/22/2001 NY 0.4 0 .4 M 10/31/2000 A father reported that his 5 month old son received an injection of Prevnar on 10/5/00 and on 10/7/00, the infant's eye "became extremely swollen and red". The reporter stated that the physician treated him with Benadryl and an unspecified antibiotic. U 10/05/2000 10/07/2000 2 UNK PVT PVT NONE NONE UNK HQ2056411OCT2000 1
0165008 01/22/2001 LA 2.0 2 .1 M 10/31/2000 A territory representative reported that a 24 month old male received an injection of Prevnar on 10/4/00 and on 10/9/00, the child developed a cold. Subsequently, he developed a syndrome described as "Henoch-Schonlein Purpura". Follow up states the patient recovered. Y 10/04/2000 10/09/2000 5 UNK PVT PVT Ciloxan, Entex UNK UNK HQ2160113OCT2000 1
0165009 01/22/2001 TN 2.0 2 .1 F 12/21/2000 A NP reported that a 25 month old female received her 1st dose of Prevnar on 10/9/00 and 2 day later, developed erythema with a warm and tender area at the injection site along with "secondary cellulitis". The pt was seen in the office that day and was prescribed cephalexin hydrochloride and warm compresses. The pt recovered. Y Y 10/09/2000 10/11/2000 2 UNK PVT PVT Nasonex Cough and runny nose UNK HQ2245014OCT2000 1
0165010 01/22/2001 OH U 10/26/2000 A sales representative reported that a pt received the 1st dose of Prevnar on 10/5/00 and the next morning, developed hoarseness. As of 10/12/00, no further information was available. U 10/05/2000 10/06/2000 1 UNK PVT PVT UNK UNK UNK HQ2247014OCT2000 1
0165012 01/22/2001 MN U 10/18/2000 A pharmacist reported that pediatric nurses have reported that babies are screaming more than with any other injections. As of 10/13/00, no further information was available. The reporter was unable to specify the number of pts who experienced this event. Additional reports will be generated when identifying information is provided. U UNK OTH OTH UNK UNK UNK HQ2290816OCT2000 1
0165013 01/22/2001 NC 0.75 M 12/20/2000 A physician reported that a 9 month old male received his 1st dose of Prevnar (approx. 1 month ago) and subsequently, experienced muscle spasms in both of his lower extremities. The physician indicated that the pt's mother called and reported that her son hand "no fever, no irritability, just pulling up of his legs". U UNK OTH OTH NONE UNK UNK HQ2310417OCT2000 1
0165014 01/22/2001 OH 1.0 1 .0 M 12/20/2000 A nurse reported that a 12 month old male received vaccines on 10/4/00 and on 10/13/00, the infant developed an injection site reaction characterized by redness, warmth, tenderness, swelling and blisters at the site of Prevnar administration. He was treated with Keflex and hot soaks. U 10/04/2000 10/13/2000 9 UNK PVT PVT UNK NONE UNK HQ2353417OCT2000 1
0165015 01/22/2001 NY 1.25 U 12/19/2000 A physician reported that a 15 month old child received an injection of HIB vaccine on 10/14/00, and the vial was inadvertently reconstituted with Prevnar. On 10/16/00, the child had redness at the injection site. The reporter declined to provide additional information and declined to grant permission for follow-up investigation. U 10/14/2000 UNK PVT OTH NONE NONE UNK HQ2474419OCT2000 1
0165017 01/22/2001 CA 1.7 1 .7 F 12/20/2000 A physician reported that a 20 month old female received an injection of Prevnar on 10/6/00. That evening, the child developed a fever of 102F, coughing and was lethargic. On 10/14/00, she was dx'd with bronchitis. The reporter stated that the bronchitis "turned into pneumonia". She was treated with Zithromax, albuterol nebulizer and Ryna (pseudoephedrine/chlorpheniramine). The child recovered. Y 10/06/2000 UNK PVT PVT NONE NONE UNK HQ2486119OCT2000 1
0165018 01/22/2001 NY 0.6 0 .6 F 12/21/2000 A physician reported a 7 month old female received Prevnar and Recombivax-HB vaccines on 10/10/00 and on 10/12/00, she developed a maculopapular rash on her arms and lower extremities. She was treated with oral diphenhydramine. U 10/10/2000 10/12/2000 2 UNK PVT PUB NONE NONE UNK HQ2494519OCT2000 1
0165019 01/22/2001 FL U 12/21/2000 A NP reported that a pt received an injection of Prevnar and subsequently, developed a fever of 102F. The fever resolved in 2 days. The pt then developed a generalized papular rash that was described as "not quite roseola in appearance". No further information was available at the date of this report. The reporter indicated that 2 pts experienced this event; however, they are not presently identifiable. An additional report will be generated when identifying information is provided. U UNK PVT OTH UNK NONE UNK HQ2593121OCT2000 1
0165021 01/22/2001 GA U 12/20/2000 A territory representative reported that a pt inadvertently received 0.4 ml of Prevnar instead of the recommended dose of 0.5 ml. A few days, post vax, the pt developed an ear infection. No further information was available at the date of this report. The reporter indicated that 3 pts experienced this event; however, they are not presently identifiable. Additional reports will be generated when identifying information is provided. U UNK OTH OTH UNK UNK UNK HQ2802226OCT2000 1
0165022 01/22/2001 CT 1.0 1 .0 M 12/19/2000 A physician reported that her 1 year old son received an injection of Prevnar on 10/29/00. That same day, he developed irritability, restlessness, decreased appetite, drowsiness, fatigue, hyperactivity and an unspecified injection site reaction. The reporter also believes that her child may have experienced hypotonic-hyporesponsive episodes as "he looked a little floppy last night". As of 10/24/00, the symptoms had not resolved. U 10/19/2000 10/19/2000 0 UNK PVT PVT UNK NONE UNK HQ2906430OCT2000 1
0165023 01/22/2001 AL 0.75 0 .7 F 12/28/2000 A physician reported that a 9 month old female received Prevnar and Hep-B vaccines on 10/24/00 and subsequently, developed a "strange" rash. The rash was described as red and papular rash over her body and a confluent, bright red rash over her entire face. She also developed an injection site reaction characterized by a "1/2 dollar-sized" area of induration and erythema at the injection site of the Prevnar injection. She was treated with diphenhydramine. As of 10/26/00, the rash persisted. U 10/24/2000 UNK PVT PVT UNK NONE Upper respiratory tract infection NOS HQ2924930OCT2000 1
0165024 01/22/2001 NJ 1.0 1 .0 F A mother reported that her 12 month old daughter received Prevnar, varicella and poliomyelitis vaccines on 10/2/00 and subsequently, developed a fever. On 10/11/00, her fever was 105.2F and the mother reports that she "may have had a febrile seizure because she was not responding appropriately and would just stare ahead at times". The mother treated her with Tylenol and the fever resolved. On 10/13/00, the child developed a rash on her trunk and face. On 10/16/00, she was seen by the physician who dx'd roseola. The roseola resolved on 10/18/00. On 10/23/00, the child developed a cough and fever of 103F. On 10/27/00, the fever resolved and she was seen by the physician who dx'd "a touch of pneumonia" and a left ear infection. She was treated with amoxicillin. As of 10/30/00, the child is improving but has developed "occasional vomiting due to coughing and gagging". Y U 10/02/2000 10/27/2000 25 UNK PVT OTH NONE NONE UNK HQ3006431OCT2000 1
0165025 01/22/2001 NY 1.6 U 12/19/2000 A physician reported that a 19 month old child received an injection of Prevnar and a few days later, developed a "cloudy right cornea". The child was seen by the physician and dx'd with keratitis. A culture was positive for Streptococcus viridans which the reporter believed was a "skin contaminant". The pt is being treated with an unspecified topical antibiotic". Y U Culture-positive for streptococcus viridans OTH OTH UNK UNK UNK HQ3270106NOV2000 1
0165026 01/22/2001 FL 1.2 1 .2 F 12/15/2000 A father, who is a physician, reported that his 14 month old daughter received Prevnar, Hep-B and HIB vaccines on 10/18/00. Thirty-six hours, post vax, she developed a persistent low-grade fever and a runny nose that started as a clear discharge and has changed to yellow-green in color. She also developed a maculopapular rash on her legs, trunk and scalp. The rash was "very, very fine" on her face and spared the diaper area. On 10/27/00, her white blood cell count was reportedly normal and a "strept test" was negative. The treating pediatrician is presuming a viral infection, possibly a sinus infection. She was treated initially with a course azithromycin and then IM ceftriaxone. Of note; this pt's grandmother became ill, following receipt of pneumococcal vaccine. See report HQ4704411DEC2000. Additional information received 12/28/2000 indicated that the rash resolved after 2 weeks. Y U 10/18/2000 10/20/2000 2 WBC-nml; Culture NOS-neg for Streptococcus PVT PVT NONE NONE UNK HQ3332107NOV2000 1
0165027 01/22/2001 TX 1.25 F 12/21/2000 A 15 month old female received Prevnar, Acel-Imune, Hib-Titer and MMR II vaccines on 7/6/00. That same day, the child developed a fever of 105.7F, "unresponsiveness, periods of blank staring, would not eat, fall over in sitting position and fall down when standing, could not walk for days". U 07/06/2000 07/06/2000 0 CBC-slight elevation in WBC OTH OTH UNK NONE UNK Unspecified reaction~DTP (no brand name)~2~0.00~In Patient HQ3502210NOV2000 1
0165028 01/22/2001 MD 1.08 F 12/19/2000 This report is concerning a 13 month old female who received Prevnar and Varivax vaccines on 7/30/00 and on 8/10/00, developed a fever, pain, "red papules, and vesicles". She was seen by the physician. The next day, the child's fever was 102F and she experienced a febrile seizure which lasted for 2 to 3 minutes. Y 07/30/2000 08/10/2000 11 UNK OTH OTH Acetaminophen NONE UNK HQ3502410NOV2000 1
0165029 01/22/2001 PA 1.25 M 12/06/2000 This report concerns a 15 month old male who received Prevnar, Comvax, Varivax and MMRII vaccines on 7/19/00. On 7/26/00, the child developed a cough and congestion. On 7/28/00, he experienced a febrile seizure which lasted for 4 to 5 minutes. ER services was called and the child was treated with albuterol. He was seen in an ER and dx'd with an ear infection. The child was treated with amoxicillin. Y Y 07/19/2000 07/28/2000 9 X-ray of chest-nml; Blood culture-neg OTH OTH Tylenol Viral upper respiratory infection URI viral NOS HQ3509010NOV2000 1
0165030 01/22/2001 AL 3.0 3 M 12/19/2000 A nurse reported that a 3 year old male received an injection of Prevnar on 11/9/00 and within 2 to 3 hours, he developed an injection site reaction characterized by an area a "quarter in size" of redness, swelling and tenderness. He also had the chills. On 11/10/00, the child was not feeling well. Follow up information received 12/29/2000 indicated the patient recovered. Y 11/09/2000 11/09/2000 0 UNK PVT OTH NONE NONE UNK HQ3619113NOV2000 1
0165031 01/22/2001 RI 0.2 0 .2 F 12/19/2000 A physician reported that her 2 month old daughter received Prevnar, Comvax, IPV and DTAP vaccines on 11/06/00. On 11/11/00, she developed a rash. On 11/12/00, the child developed swelling of her hands and feet. U 11/06/2000 11/11/2000 5 UNK PVT OTH NONE NONE UNK HQ3666214NOV2000 1
0165032 01/22/2001 FL 7.0 7 F 11/17/2000 A mother reported that her 7 year old daughter received an injection of Prevnar on 11/14/00. Approx. 15 minutes, post vax, the child "fell to the floor, her eyes rolled back into her head and she was jerking". She was treated with an "ammonia inhaler". The child also developed soreness at the injection site. Follow up states the patient recovered. Y 11/14/2000 11/14/2000 0 UNK PVT OTH Prozac, Remeron,Tylenol URI Nausea; Pyrexia; Sore throat NOS; Ear infection NOS; Myringotomy HQ3780316NOV2000 1
0165033 01/22/2001 MI 0.8 0 .8 F 12/21/2000 A mother who is a nurse, reported that her 10 month old daughter received an injection of Prevnar on 11/13/00 which may have inadvertently been given SC. The child subsequently developed an injection site reaction characterized by redness and a bump. U 11/13/2000 11/13/2000 0 PVT OTH NONE UNK UNK HQ3792316NOV2000 1
0165034 01/22/2001 WI 0.75 M 12/22/2000 A physician reported that a 9 month old male received an injection of Prevnar in 8/00. Seven to 10 days, post vax, he developed a fever, led discomfort and a decrease in the use of the leg in which the Prevnar was administered. The reporter indicated that the child may have experienced a minor trauma from "a fall" around the time of the event. The child recovered. Y Y 08/01/2000 UNK PVT PVT NONE NONE UNK HQ3960521NOV2000 1
0165035 01/22/2001 TX 1.25 1 .3 M 12/19/2000 A nurse reported that a 13 month old male received Prevnar, TriHibit and IPV vaccines on 11/16/00. Within 24 hours, he developed "migratory hives" over his body and swelling around the eyes. The reporter indicated that the child had mild congestion and a rash at the time of immunization. Follow up information received 12/29/2000 indicated the patient recovered. Y 11/16/2000 11/17/2000 1 UNK PVT OTH UNK Mild congestion and rash UNK HQ3976921NOV2000 1
0165036 01/22/2001 SC 0.3 0 .3 M A mother reported that her 4 month old son received Prevnar, IPV, HIB and DPT vaccines on 8/8/00. On 8/10/00, he experienced an upper respiratory tract infection and "severe reflux". The pt was seen by an ENT physician, who surgically removed the child's adenoids and dx'd him with asthma. The child was also seen in the ER for both upper respiratory tract and an ear infection. He was treated with numerous antibiotics; however, "none of them have helped". Y U 08/08/2000 08/10/2000 2 UNK PVT PVT NONE NONE Adenoidectomy HQ3977121NOV2000 1
0165037 01/22/2001 GA U 12/15/2000 A territory representative reported that a pt inadvertently received a 0.4 ml dose of Prevnar instead of the recommended dose of 0.5 ml. A few days, post vax, the child developed an upper respiratory infection. No further information was available at the date of this report. This is 1 of 2 pts from this facility who had an adverse experience following receipt of Prevnar. U UNK OTH OTH UNK UNK UNK HQ4044222NOV2000 1
0165038 01/22/2001 WA 0.9 0 .9 F 12/15/2000 A nurse reported that a 10 month old female received a SC injection of Prevnar on 11/28/00. The next day, she developed an injection site reaction characterized by swelling and redness. Follow up states the day after the Prevnar injection the patient was seen by a physician and diagnosed with cellulitis. The patient was treated with Augmentin and recovered by 12/01/2000. Y 11/27/2000 11/28/2000 1 UNK PVT PVT NONE NONE UNK HQ4236229NOV2000 1
0165039 01/22/2001 NE 0.71 0 .7 F 12/15/2000 A physician reported that an 8 month old female received an injection of Prevnar on 10/17/00 and within 12 hours, post vax, the child experienced vomiting. Twenty-four hours, post vax, she developed a fever of 102F and erythema multiforme. The fever and vomiting resolved. This is 1 of 3 pts from this facility who had an adverse event following receipt of Prevnar. Follow up information received on 12/29/2000 the erythema multiforme resolved. Y 10/17/2000 10/18/2000 1 UNK PVT OTH NONE UNK UNK HQ4454205DEC2000 1
0165040 01/22/2001 AZ 0.7 F 12/20/2000 A mother reported that her 8 month old daughter received her 2nd dose of Prevnar on 11/14/00. That afternoon, her eyes began rolling around and she was sleepy. Between 21:00 on 11/14/00 and 04:30 on 11/15/00, she vomited 8 times. She was taken to the hospital; she had a fever of 102.5F and an ear infection. She was treated with azithromycin, acetaminophen and IV fluids. She was released from the hospital at 09:30 on 11/15/00. The fever resolved by 11/17/00. This child developed a fever, vomiting and an ear infection following a previous dose of Prevnar. See MCN HQ4086327NOV2000. Y Y 11/14/2000 11/15/2000 1 UNK OTH OTH UNK UNK UNK Fever, vomiting and an ear infection~Pneumo (Prevnar)~1~0.00~In Patient HQ4626106DEC2000 1
0165041 01/22/2001 VT 2.0 2 .1 F 12/21/2000 A physician reported that a 2 year old female received an injection of Prevnar on 9/20/00. That same day, the child developed a fever of greater than 102F. She recovered. This is 1 of 5 pts from this facility who experienced this event following receipt of 3 different lots of Prevnar. Y 09/20/2000 09/20/2000 0 NONE PVT OTH NONE NONE Premature baby ~Pneumo (Prevnar)~~0.00~In Sibling HQ0856511SEP2000 1
0165042 01/22/2001 CA 0.7 F 10/26/2000 A territory representative reported that an 8 month old female received Prevnar and Acel-Imune vaccines on 8/29/00. On 9/2/00, she developed a generalized rash. She was treated with oral diphenhydramine and recovered. Y 08/29/2000 09/02/2000 4 UNK PVT PVT NONE NONE UNK HQ0860711SEP2000 1
0165043 01/22/2001 CA 1.5 1 .5 F 12/19/2000 A physician reported that an 18 month old female received Prevnar, IPV and Infanrix vaccines on 9/8/00. On 9/9/00, she developed a "golf ball-sized" area of swelling at the site of the Prevnar injection. She was seen by the physician, who prescribed cold compresses and acetaminophen. She recovered. Y Y 09/08/2000 09/09/2000 1 NONE PVT OTH NONE NONE UNK HQ0950313SEP2000 1
0165044 01/22/2001 SC 1.25 1 .3 M 12/21/2000 A physician reported that a 15 month old male received Prevnar, IPV and Hib-Titer vaccines on 9/11/00. Within 2 hours, he developed hives. He was seen by the physician and treated with diphenhydramine. He recovered within 3 hours. Y Y 09/11/2000 09/11/2000 0 NONE PVT PVT NONE NONE Eczema NOS HQ0971313SEP2000 1
0165045 01/22/2001 WI U 10/26/2000 A physician reported that a pt received an injection of Prevnar and subsequently developed a rash. The pt was taking amoxicillin at the time. The reporter noted that this event was a "possible allergic reaction". No further information was available at the date of this report. U UNK OTH OTH Amoxicillin UNK UNK HQ1068515SEP2000 1
0165047 01/22/2001 GA U 10/16/2000 A pediatrician reported that a child received an injection of Prevnar. Approx. 24 to 48 hours, post vax, the child developed a "non-hive" rash. No further information was available at the date of this report. The reporter indicated that 5 or 6 pts experienced this event; however, they are not presently identifiable. Additional reports will be generated when identifying information is provided. U UNK PVT OTH UNK UNK UNK HQ1298521SEP2000 1
0165048 01/22/2001 CO 0.5 M 10/11/2000 A territory representative reported that a 6 month old male received his 1st dose of Prevnar, as well as, Tripedia and Act-Hib vaccines on 9/18/00. On 9/19/00, the infant developed rash described as looking "almost like prickly heat or roseola". U 09/18/2000 09/19/2000 1 UNK PUB OTH NONE NONE UNK HQ1339424Sep2000 1
0165049 01/22/2001 IL U 10/13/2000 A physician reported that children experienced pain during the administration of Prevnar. The physician stated that more pain is experienced during Prevnar administration compared to other vaccines. No further information was available at the date of this report. The reporter was unable to specify the number of pts who experienced this event. Additional reports will be generated when identifying information is provided. U UNK PVT OTH UNK UNK UNK HQ1362225SEP2000 1
0165050 01/22/2001 KS 0.2 0 .2 M 12/15/2000 Subsequent to receiving vax, the pt developed a fever, irritability and fussiness. The mother reported that the pt would not take his bottle. He was treated with Tylenol. The fever resolved in 24 hours. A copy of this report was forwarded to Aventis Pasteur and Merck, Sharp & Dome, manufacturers of the concomitantly administered vaccines. Y 07/02/2000 07/02/2000 0 UNK PVT OTH NONE NONE UNK HQ1368725SEP2000 1
0165051 01/22/2001 IN U 10/04/2000 Subsequent to receiving vax, the pt developed a fever of 102 degrees. The reporter indicated that 2 pts experienced fever; however, they are not presently identifiable. Additional reports will be generated when identifying information is provided. U UNK OTH OTH UNK UNK UNK HQ1422626SEP2000 1
0165052 01/22/2001 NJ 0.5 0 .5 M 12/21/2000 Subsequent to receiving vax, the pt developed a fever of 103 degrees which lasted 8 hours. Additional information received from the reporter provided lot numbers and number of previous doses received for the concomitantly administered vaccines. The pt remained recovered. Y 03/23/2000 03/23/2000 0 NONE PVT OTH NONE NONE UNK HQ1541328SEP2000 1
0165053 01/22/2001 IL 1.25 M 10/16/2000 Subsequent to receiving vax, the pt developed a fever of 102.3F and had one large vomiting episode. The fever persisted as of 09/28/2000. A copy of this report has forwarded to Merck, manufacturer of MMR. U 09/27/2000 09/27/2000 0 UNK OTH OTH NONE UNK UNK HQ1663902OCT2000 1
0165054 01/22/2001 IN U 10/04/2000 Subsequent to receiving vax, the pt developed a body rash. The reporter indicated that the rash resolved spontaneously. This is 1 of 3 pts who had an adverse experience following receipt of Prevnar. Y UNK OTH OTH UNK UNK UNK HQ1690302OCT2000 1
0165055 01/22/2001 FL 1.6 1 .6 F 10/10/2000 Within 24 hours post vax, the pt developed a fever of up to 100.5 degrees F. The reporter indicated that as of 09//, the child's fever rose to 102.2 degrees F. U 09/22/2000 09/22/2000 0 UNK PVT PVT NONE NONE UNK HQ1702303OCT2000 1
0165056 01/22/2001 WI U 10/06/2000 Subsequent to receiving vax, the pt developed warmth at the injection site. No further information was available at the date of this report. U UNK OTH OTH UNK UNK UNK HQ1775104OCT2000 1
0165057 01/22/2001 IL 0.2 U 12/21/2000 Four to five days post vax, the pt developed a fever which rose to 102 degrees and resolved within 24 hours. The reporter indicated that 4 infants experienced this event; however, they are not presently identifiable. Additional information received from the vaccine provider stated that the infant was given a complete physical within 24 hours of the event. Concomitant vaccines included DTaP, Hib, and IPV. The pt remained recovered. The reporter stated that the office was unable to provide identifying information for the other pts. Y UNK OTH OTH NONE NONE UNK HQ1779304OCT2000 1
0165058 01/22/2001 NJ U 10/10/2000 One day post vax, the pt developed a high fever. The reporter indicated that 2 to 3 children experienced this event; however, they are not presently identifiable. Additional reports will be generated when identifying information is provided. U UNK OTH OTH UNK UNK UNK HQ1788804OCT2000 1
0165059 01/22/2001 MD U 10/06/2000 Seven days post vax, the pt developed a rash (hives). A copy of this report has been forwarded to Aventis Pasteur, manufacturer of IPV. U 07/11/2000 07/18/2000 7 UNK PVT OTH UNK UNK UNK HQ1798104OCT2000 1
0165060 01/22/2001 PA 4.0 4 M 10/17/2000 Subsequent to receiving vax, the pt developed an injection site reaction characterized by very large circular area 1.5 - 2 inches, of redness, hardness, swelling and pain. From 3-5 days post vax, the injection site redness slowly dissipated, the swelling went down and the hardness resolved. At the time of immunization, the child was diagnosed with recurrent acute otitis media. After 7 days the injection site pain resolved, the pt recovered. Y 09/19/2000 09/19/2000 0 UNK PVT PVT Augmentin recurrent acute otitis media Otitis media chronic NOS HQ1890206OCT2000 1
0165061 01/22/2001 MI 1.3 1 .3 M One day post vax, the pt became very sleepy and had a decreased appetite. Four days post vax, the pt developed an ear infection. The pt was treated with Ceftin. U 09/22/2000 09/26/2000 4 UNK PVT PVT NONE NONE UNK HQ1949009OCT2000 1
0165062 01/22/2001 OK U 12/19/2000 Subsequent to receiving vax, the pt developed a local reaction. No further information was available at the date of this report. The reporter was unable to specify the number of pts who experienced this event. Additional reports will be generated when identifying information is provided U UNK OTH OTH UNK UNK UNK HQ2236314OCT2000 1
0165064 01/22/2001 OH F 12/15/2000 One day post vax, the pt developed a knot at the injection site. No further information was available at the date of this report. U 10/17/2000 10/18/2000 1 UNK OTH OTH UNK UNK UNK HQ2612223OCT2000 1
0165065 01/22/2001 OH U 12/21/2000 One day post vax, the pt developed a skin knot at the injection site. No further information was available at the date of this report. U UNK OTH OTH UNK UNK UNK HQ2622123OCT2000 1
0165066 01/22/2001 IL 0.08 0 .2 M 12/21/2000 Subsequent to receiving vax, the pt developed severe swelling in the left leg that extended from the knee to the groin. Prevnar and ProHIBit were both injected into the left leg. A copy of this report has been forwarded to Aventis Pasteur, manufacturer of ProHIBit. U 09/20/2000 UNK PVT OTH NONE NONE UNK HQ2638523OCT2000 1
0165067 01/22/2001 CA U 12/21/2000 Subsequent to receiving vax, the pt developed a fever. A few days post vax the pt was diagnosed with pneumonia. The pt was treated with Zithromax. No further information was available at the date of this report. U UNK OTH OTH UNK UNK UNK HQ2646623OCT2000 1
0165068 01/22/2001 KY 0.6 0 .6 M 12/21/2000 subsequent to receiving vax, the pt developed hives. A copy of this report has been forwarded to Aventis Pasteur, manufacturer of IPV. U 10/19/2000 10/19/2000 0 UNK PVT PVT Albuterol; Flovent UNK Bronchospasm NOS; Eczema NOS HQ2650123OCT2000 1
0165124 01/22/2001 MI 1.5 F 12/21/2000 Physician reported that patient received vaccination on 10/19/00 and that same day developed a fever "up to 105 deg. F". She was treated with Tylenol (acetaminophen). U 10/19/2000 10/19/2000 0 UNK PUB OTH NONE NONE UNK HQ2800326OCT2000 1
0165125 01/22/2001 ME 0.25 M 12/19/2000 A territory representative reported that the patient received the vaccination and subsequently developed a fever which resolved within 1.5 weeks. He then developed a rash which spread over his entire body. Additional information received from the physician on 12/22/2000 indicated that the rash resolved. Y UNK PVT OTH UNK UNK UNK HQ2920130OCT2000 1
0165126 01/22/2001 FL 0.6 0 .7 F 12/19/2000 Mother, who is also a nurse, reported that her daughter received her first dose of Prevnar as well as Tripedia (Aventis Pasteur) on 10/27/2000 and 12 to 24 hours later, developed bronchiolitis with a "raspy" cough. She has a recent medical history (approximately 3 weeks ago) of RSV with a "raspy" cough, fever of 103 deg. F and "double" ear infections. The fever resolved 3 days later. She was treated with antibiotics and had been symptom-free for approximately 10 days prior to immunization. Follow up information received 12/28/2000 from the physician indicated the patient received Prevnar and Tripedia on 10/25/2000. On 10/30/2000 the patient experienced wheezing. Fifteen days later she was seen by the physician and a diagnosis of otitis media was made. The patient was prescribed an antibiotic. The patient was seen by the physician again on 11/28/2000 and had recovered. The physician indicated that these events were unrelated to the vaccine administration. Y 10/26/2000 10/30/2000 4 UNK PVT OTH NONE NONE Bronchiolitis, ear infection NOS, pyrexia HQ3004231OCT2000 1
0165127 01/22/2001 NE 1.0 1 .0 M 12/21/2000 Physician reported that patient received Prevnar, Comvax (Merck), and Varivax (Merck) on 11/01/00. Within 12 hours post immunization, he developed vomiting. The physician indicated that as of 11/05/00, the patient has vomited once each day since vaccination. This is 1 of 3 children from this facility who has had an adverse experience following receipt of Prevnar. Additional information received 12/29/2000 indicated the patient recovered. Y 11/01/2000 11/01/2000 0 UNK PVT OTH NONE UNK UNK HQ3378308NOV2000 1
0165129 01/22/2001 FL 0.25 0 .3 F 12/21/2000 The mother, who is a healthcare professional, reported that the patient received Prevnar and Recombivax-HB (Merck) on 11/10/00. That evening she developed redness, swelling, and inflammation that presented as a "big ball" at the injection site. Touching the site caused the child to cry. She was treated with cold compresses and acetaminophen. On 11/11/00, the redness resolved. As of 11/13/00, the "big ball" was still present. U 11/10/2000 11/11/2000 1 UNK PVT OTH NONE UNK UNK HQ3666514NOV2000 1
0165131 01/22/2001 VA U 12/21/2000 A physician reported that a patient received a Prevnar vaccine and 4 to 10 days later developed diarrhea. U UNK OTH OTH UNK UNK UNK HQ3958521NOV2000 1
0165132 01/22/2001 AZ 0.5 F 12/21/2000 Mother reported that the patient received her first dose of Prevnar along with IPV (Aventis Pasteur SA), DTaP (manufacturer unknown), and Hib (manufacturer unknown) on 09/06/00 and subsequently developed a fever of 101.8 deg. F. and vomiting. One or two days post-immunization, she developed an ear infection. She was treated with either azithromycin or amoxicillin. Y 09/06/2000 UNK OTH OTH UNK UNK UNK HQ4086327NOV2000 1
0165133 01/22/2001 CT 2.0 2 .0 F 12/19/2000 A territory representative reported that a patient received a Prevnar vaccine and subsequently developed hives. The patient was treated with diphenhydramine and recovered within 24 to 48 hours. No further information was available at the date of this report. Additional information received on 01/04/2001 from the physician indicated the patient, a 2-year-old female, received the Prevnar injection on 11/20/2000. The adverse experience occurred 4 hours post-immunization. Y 11/20/2000 11/20/2000 0 UNK PVT OTH UNK UNK UNK HQ4090527NOV2000 1
0165134 01/22/2001 VT 2.0 2 .1 F 12/21/2000 Physician reported that patient received a Prevnar vaccine on 9/20/2000, and on 9/24/2000 she developed a fever of greater than 102 deg. F. The patient recovered. This is 1 of 5 patients from this facility who experienced this event following receipt of 3 different lots of Prevnar. Y 09/20/2000 09/24/2000 4 UNK PVT OTH NONE NONE Prematurity ~Pneumo (Prevnar)~~0.00~In Sibling HQ4320001DEC2000 1
0165135 01/22/2001 VT 0.5 0 .5 F 12/21/2000 Physician reported that patient received Prevnar, Hib-Titer, and DPT (manufacturer unknown) on 8/19/2000. The next day the patient developed a fever of greater than 102 deg. F. This is 1 of 5 patients from this facility who experienced this event following receipt of 3 different lots of Prevnar. U 08/19/2000 08/20/2000 1 NONE PVT OTH NONE NONE UNK HQ4320101DEC2000 1
0165136 01/22/2001 VT 0.75 0 .8 M 12/14/2000 Physician reported that patient received Prevnar, IPV (Aventis Pasteur SA), and hepatitis B vaccines on 9/19/2000. The next day the patient developed a fever of greater than 102 deg. F. He recovered. This is 1 of 5 patients from this facility who experienced this event following receipt of 3 different lots of Prevnar. Y 09/19/2000 09/20/2000 1 NONE PVT OTH NONE NONE UNK HQ4320201DEC2000 1
0165137 01/22/2001 VT 1.08 1 .0 M 12/21/2000 Physician reported that patient received Prevnar, haemophilus B (manufacturer unknown), measles, mumps, rubella (manufacturer unknown), and varicella virus (manufacturer unknown) vaccines on 9/15/2000. On 9/18/2000 the patient developed a fever of greater than 102 deg. F. He recovered. This is 1 of 5 patients from this facility who experienced this event following receipt of 3 different lots of Prevnar. Y 09/15/2000 09/18/2000 3 NONE PVT OTH NONE NONE UNK HQ4320301DEC2000 1
0165138 01/22/2001 PA 0.3 0 .3 F 12/21/2000 Physician reported that patient received Prevnar, Acel-Imune, Hib-Titer, and IPV (Aventis Pasteur SA) on 8/21/2000. Within 24 hours post-immunization, she developed vomiting and diarrhea. She also developed redness, swelling, and warmth at an unspecified injection site. The vomiting and diarrhea resolved after 2 to 3 days. Y 08/21/2000 08/22/2000 1 UNK PVT OTH NONE NONE UNK HQ4334301DEC2000 1
0165139 01/22/2001 NE 0.75 0 .7 F 12/14/2000 Physician reported that patient received a Prevnar vaccine on 11/03/2000, and five hours post-immunization, she developed vomiting. The event lasted 24 hours. The patient recovered. This is 1 of 3 patients from this facility who had an adverse experience following receipt of Prevnar. Y 11/03/2000 11/03/2000 0 UNK PVT OTH NONE UNK UNK HQ4454305DEC2000 1
0165069 01/23/2001 PA 1.75 1 .7 M 01/16/2001 Autistic child: difficult infant who did not develope age appropriate speed. He was referred for evaluation at 2 years of age with ultimate dx of autism. Physician feels speech not present early and temporal association with vaccine. 60 day follow-up states the event was not due to vaccine. Y Y Y 08/24/1999 01/05/2000 134 Evaluated by geneticist, psychologist and specialist in autism. PVT PVT NONE NONE possible speech delay 1
0165070 01/23/2001 GA 0.8 0 .8 F 01/15/2001 Hyporesponsive, hypotonic reactions with vomiting, fever and diarrhea that occurred acutely, 8 hours, post vax of DTAP. Called 911; because could not arouse and brought to ER. Y Y 2 Y 01/03/2001 01/03/2001 0 EEG-nml; Blood and Stool cultures-neg; WBC-20.9; Hgb-12.8; P/T-499 PVT PVT NONE NONE NONE 1
0165071 01/23/2001 NY 36.0 36 M 01/18/2001 Shortly after receiving 1st of 3 shots, started experiencing sharp pain in right knee. After receiving 2nd shot, joint pain spread rapidly to left knee, feet, hands, left elbow and both hips. I have also experienced a constant burning and tingling sensation in both knees. Symptoms have been worsening over the past year and a half. I have lost considerable time from work and my personal life has been dramatically affected. I had no prior history of arthritis or any joint pain prior to receiving the Lymerix vaccine. Drugs that I have been treated with include Vioxx, indomethacin, Cortizone shot, hydroxychloroquine and prednisone thus far. None of these drugs, with exception of prednisone, have done much for the pain, discomfort and loss of mobility. I am currently seeking treatment for relief from the affects of the vaccine with several doctors. Report 2001005977-1 described arthrilgia in a 37-year-old male who received LYMERIX. Concurrent medical conditions included prostatitis (1995) and gastroesophageal reflux disease. A diagnosis of hypertention was made sometime in the year 2000. The patient did not have gout, psoriasis, Crohn's disease, or Lyme disease. There was no family history of rhematoid arthritis, lupus erythematosus, or other rheumatological disorders. There was no illness at the time of immunization. There were no concurrent medications. The paitent received his first injection of LYMERIX on 10 May 1999 at his place of employment. On 16 June 1999, he experienced arthralgia of the fingers, the toes, and both knees. The paitent received his second injection of LYMERIX on 17 June 1999. The patient was seen by a rheumatologist, an orthodedist, and an infectious disease specialist. No evidence of arthritis was found. He was treated with 10 to 15 mg of PREDNISONE daily, beginning on an uspecified day in June 2000. At the time the reporting physician examined the patient, the patient was taking PREDNISONE. No overt joint swelling, erythema, or warmth was observed by the reporting physician, No joint fluid was obtained. On 20 February 2001, RF, ESR, and CRP were nomral. Rapid plasmin reagin, antistreptolysin O titer, Lyme serlolgy, and Lyme Western blot were negative. Antinuclear antibody titer was positve at 1:80. The LYMERIX administration immunization series was stopped. The most recent information was received from the infectious desease specialist on 16 April 2001. This physician considered the arthralgia to be moderate in intesity and possibly related to LYMERIX administration. The arthralgia presisted as of 13 March 2001. As of 28 March 2001, the patient's serlogies have continued to remain negative. The adverse event of arthralgia does not meet ICH serious criteria, but is being submitted as an expedited report by special FDA request per the June 28, 2000 letter. Y Y N 05/10/1999 06/10/1999 31 ANA-positive; Antinuclear antibody titer, 20-Feb-2001 1:80 (normal, < 1:40); Lyme serology, negative, 20-Feb-2001; Lyme Western Blot, negative, 20-Feb-2001; Rapid Plasmin Reagin, negative, 20-Feb-2001 OTH PUB NONE 20010059771 1
0165073 01/23/2001 NH U 01/19/2001 A territory representative reported that a pt received an injection and subsequently developed flu-like symptoms. The pt was hospitalized. The reporter indicated that 11 pts experienced this event however they are not presently identifiable. Additional reports will be generated when identifying information is provided. Y U UNK OTH OTH UNK UNK UNK HQ6140219JAN2001 1
0165074 01/23/2001 NY 60.0 58 F 01/16/2001 Pt experienced severe fatigue, tingling through body, muscle pain, joint pain, rapid heart beat, anemia, stomach pain, pressure in head and eyes, sore throat, numbness in jaw and nose area, and was sick for 8 months before finally being treated with doxycycline. Y N 06/04/1999 03/01/2000 271 EKG, CAT scans, MRI, numerous blood tests PVT PVT NONE NONE 1
0165075 01/23/2001 MD 39.0 38 F 01/17/2001 Pt experienced headaches, depression, multi-system problems, pain in muscles and tendons within three days post vax. Pt also developed arthritis in right shoulder, knee and hips, increased fibromyalgia, back, neck and body pain. N 04/28/1999 05/01/1999 3 PVT UNK Anexia Lyme infection disc degeneration, mild intermittent fibromyalgia 1
0165076 01/23/2001 WA 1.25 1 .3 F 01/12/2001 Subsequent to receiving vax, the pt developed a fever of up to 101. Five days post vax, the pt developed a fine imprint macular rash on neck and trunk. Y 01/05/2001 01/10/2001 5 PVT PUB Augmentin sinusitis NONE 1
0165077 01/23/2001 SC 2.0 2 .1 F Pt developed redness/edema at injection site noted within 24 hours post vax. (1.5 X .75 inch area) Pt was treated with Benadryl, analgesics and warm compress. 01/09/2001 01/10/2001 1 NONE PVT OTH NONE 1
0165078 01/23/2001 PA 0.9 0 .9 M 01/10/2001 Pt developed a fever of 102, vomiting and crying inconsolably. Injection site clear. The pt recovered later that day, fever subsided, no longer crying and no vomiting. Y 01/09/2001 01/10/2001 1 NONE PUB PUB NONE NONE 1
0165079 01/23/2001 CA 3.0 3 F 01/12/2001 Subsequent to receiving vax, the pt developed a cough with a fever of 100 degrees. One day post vax the pts fever was up to 103.8. Two days post vax the pts fever rose to 105.4 and was accompanied by a stuffy nose. Pt had a normal exam and normal urine sample. Y U 01/08/2001 01/09/2001 1 urine analysis PVT UNK slight cough NONE 1
0165080 01/23/2001 NY 1.5 1 .5 F 01/12/2001 One day post vax, the pt developed urticarial rash. Pt otherwise stable. 01/08/2001 01/09/2001 1 NONE UNK UNK ??? NONE asthma;eczema 1
0165081 01/23/2001 IN 1.08 1 .0 F 01/17/2001 Eight days post vax, the pt developed a fever to 101 that lasted for three days. Pt also developed a cough, conjunctivitis maculopapular rash to torso, pharyngitis, decreased appetite and irritability. Illness appeared consistent with measle like illness. Pt still symptomatic 13 days post vax. Y N 01/04/2001 01/12/2001 8 PVT PUB Tylenol NONE 1
0165082 01/23/2001 FL 1 .5 M 01/08/2001 Pt experienced swelling/erythema of greater than 50% of left thigh. Y 01/04/2001 01/06/2001 2 PVT UNK NONE 1
0165083 01/23/2001 CA 1.6 1 .6 M Pt experienced a local reaction at the injection site. Y Y 01/12/2001 01/13/2001 1 PVT PVT NONE 1
0165084 01/23/2001 PA 1.0 1 .0 F 01/19/2001 Pt presented with multiple fine point red vesicles in various stages on cheeks, arms, back, trunk, and legs. Temperature up to 104.5. Y 01/09/2001 01/17/2001 8 PVT PVT NONE 1
0165085 01/23/2001 CA 1.8 1 .8 U Within 11 days post vax the pt developed a fever and a non-pruritic rash from the face down. U 01/04/2001 01/14/2001 10 PVT UNK Pediazole Otitis Media reactive airway disease 1
0165086 01/23/2001 CA 1.0 1 .1 M 01/12/2001 With one day post vax, the pt developed a mild case of chickenpox. N 01/10/2001 01/11/2001 1 OTH PUB NONE NONE 1
0165087 01/23/2001 CA 0.5 0 .5 F 01/15/2001 Pt experienced a localized reaction. Y 01/12/2001 01/12/2001 0 PVT PUB NONE NONE 1
0165088 01/23/2001 NJ 0.3 0 .4 M 01/17/2001 On 1/9/01 the pt was irritable and experienced a fever of 102. Seen in office. On 1/10/01 was seen in the ER. Y U 01/08/2001 01/09/2001 1 PUB PUB NONE NONE NONE 1
0165089 01/23/2001 WA 45.0 45 F 01/19/2001 Pt developed extensive hives all over body, was relieved with diphenhydramine. Y 01/12/2001 01/13/2001 1 PVT PVT NONE Sulfa 1
0165090 01/23/2001 CA 32.0 32 F 01/11/2001 Pt experienced bruising at injection site for two weeks post vax. Pts arm is continuously sore at the site and the muscles ache constantly. Area is very sore. 12/13/2000 12/13/2000 0 NONE PUB UNK 1
0165091 01/23/2001 FL 72.0 72 M 01/08/2001 Pt experienced a sore neck for 10 days; chills/fever and congestion for 3 days; both wrists and knees were sore a swollen for 3 days; soreness at the bottom of rib cage for 21 days; constipation and loss of appetite for 14 days; and ears were plugged up for 21 days. Y 12/08/2000 12/09/2000 1 PVT UNK NONE NONE 1
0165092 01/23/2001 MN 69.0 69 F 01/16/2001 Within one day post vax, the pts left upper arm was red, swollen and warm to the touch. By that afternoon it had spread to the forearm as well. Pt treated with Riaxin for 10 days. Y Y 01/05/2001 01/06/2001 1 OTH PUB NONE 1
0165093 01/23/2001 AR 4.0 4 M 12/18/2000 Pt developed raised red bumps on face and trunk one day post vax that last for 10 days. Y 11/17/2000 11/18/2000 1 NONE PUB PUB NONE NONE NONE AR0105 1
0165094 01/23/2001 CA 77.0 77 F 11/29/2000 Pt reported experiencing difficulty lifting her left arm since receiving the vax. The arm is in a lot of pain. N 11/06/2000 PUB PUB UNK NONE diabetes; alzheimers disease; heart problems CA000161 1
0165095 01/23/2001 NV 66.0 66 F 12/14/2000 Pt developed hives and a thick tongue. Y U 11/03/2000 11/13/2000 10 OTH UNK 1
0165096 01/23/2001 MA 53.0 53 F 01/15/2001 Approximately 24 hours post vax the pt developed a fine red rash on both forearms from the elbows to the wrists, very itchy. Pt was seen by physician and treated with Prednisone and Benadryl for 5 days. The rash subsided in about one week with no recurrence. Y 11/15/2000 11/17/2000 2 NONE PUB PUB Pepcid; Topidol; Lipitor cardiac cath stint; hypertension; diabetes type II; increased cholesterol 1
0165097 01/23/2001 CA 61.0 60 F Pt developed Bells Palsy. Treated with Prednisone. Y Y 11/06/1999 11/22/1999 16 MRI negative PVT UNK Prozac; Vicodan; Areida; MS Contin Metastatic breast cancer Sulfa allergy; cancer 1
0165098 01/23/2001 AZ 33.0 23 F 01/16/2001 Pt experienced pain radiating from right deltoid area. Y 01/06/2001 01/06/2001 0 MIL MIL 1
0165101 01/23/2001 WA 44.0 44 F 01/10/2001 Within one hour post vax, the pt experienced head pressure, flushing of face, trunk and arms, upper body achiness, eye irritation without redness or drainage, and malaise. Y 01/05/2001 01/05/2001 0 Normal CBC, ESR, CRP (C reactive protein) PVT PVT Duragesic, methylphenidate, Estraderm hepatitis C endometriosis; cephalosporins -> hives 1
0165102 01/23/2001 PA 43.0 43 F 01/16/2001 Four hours post vax, the pt developed a raised, red wheal area with red edge at injection site that was warm to the touch. Pt instructed to treat with ice and Tylenol. Pt returned to office approximately 2 hours later with large 10 X 12 cm wheal on left upper extremity and injection site. Area remained warm to the touch. Pt denied any respiratory difficulty. Temperature 98 degrees, heart rate 62/min, BP 120/80. Pt treated with Atarax, Prednisone and cool compresses. Pt advised to seek urgent care if any SB, palatal swelling or other acute changes. Y Y 01/15/2001 01/15/2001 0 NONE PVT OTH Allegra; Serevent;Pulmocort inhaler; Acipher; Nasonex; Sudafed; ???? asthma; seasonal allergies; endometriosis 1
0165103 01/23/2001 PA 10.0 9 F 11/16/2000 Immediately, post vax, the pt became rigid with her eyes rolled back in her head and loss of consciousness. She was lifted to the floor in RN's lap. Vital signs stable. Circumoral pallor. Ammonia ampule used. Episode lasted approximately 1 minute with recovery after 30 minutes. Pt experienced nausea and headache. Resolved spontaneously. Y 11/16/2000 11/16/2000 0 PUB OTH NONE NONE NONE PA0106 1
0165104 01/23/2001 MD 5.0 4 M 01/15/2001 Subsequent to receiving Varivax, the pt was diagnosed with chicken pox. U 10/08/1999 01/11/2001 461 PVT PVT 1
0165105 01/23/2001 OH 25.0 25 F 01/12/2001 Two hours post vax, the pt began developing hives and itching on arms, chest and hands. Subsequently the pts lips became swollen, left eyelid was swollen and pt experienced a sore throat. There was no shortness of breath. The pt was treated with 2 doses of Benadryl. The hives continued to progress and pt was treated with Atarax every 6 hours and started Medrol dose pak. The pt then saw improvement. Y 01/10/2001 01/10/2001 0 NONE PVT PVT penicillin; ibuprofen; Percoset;Rhoban postpartum NONE 1
0165106 01/23/2001 MN 49.0 49 F 01/16/2001 Pt experienced severe arm pain, numbness and muscle soreness. Y N 10/03/2000 10/04/2000 1 MRI and EMG pending PVT PVT 1
0165107 01/23/2001 NY 1.2 1 .2 F 01/12/2001 Five days post vax, the pt developed a fine, papular, red rash on facial area. By seven days post vax, the rash had generalized over entire body area. The pt had no fever, no vomiting and no diarrhea. Y Y 01/05/2001 01/11/2001 6 NONE PVT UNK NONE 1
0165108 01/23/2001 MI 1.25 1 .3 F 01/11/2001 Pt experienced swelling at the injection site, progressing to involve the entire left thigh, left leg and left foot. The pt developed redness around the site of injection. Y 01/10/2001 NONE PVT PVT 1
0165109 01/23/2001 WI 18.0 18 F 01/15/2001 This patient had a 3 inch diameter, red hard, warm, area on her left arm, a fever, migraine with sensitivity to light and sound, left arm pain, wrist and elbow pain, with movement over 1/2/ inch. Y U 01/10/2001 01/11/2001 1 PUB PUB NONE NONE NONE 1
0165110 01/23/2001 TX 35.0 35 M 01/12/2001 This patient has angioedema, lip swelling, and chest tightness. Y Y 01/12/2001 01/12/2001 0 Chest X-Ray - Clear MIL MIL Fioricet, Adenergan Angioedema Hypertension, Migraines. 1
0165111 01/23/2001 CA 1.3 1 .4 F 01/13/2001 This patient had a generalized seizure lasting one minute. The was taken to the ER at night. The patient had received DTAP, HIB vaccine during the during the day. Y Y 01/12/2001 01/12/2001 0 NONE PVT PUB NONE NONE NONE 1
0165112 01/23/2001 MI 5.0 5 M 01/15/2001 The day of the vaccine the patient was very lethargic and couldn't walk. The next day he couldn't wake until evening time. Y 01/09/2001 01/09/2001 0 PVT OTH NONE NONE Asthm~DTaP (no brand name)~2~0.50~In Patient 1
0165113 01/23/2001 MS 4.0 4 F 01/17/2001 There was a large area of redness and induration that is areolar on left anterior thigh where one received DPT. Y 01/14/2001 01/15/2001 1 NONE PVT PVT Amoxil Patient had been treated for tonsillitis. NONE 1
0165114 01/23/2001 MI M 01/16/2001 This patient had redness at the site of injection. U 01/15/2001 01/16/2001 1 PVT PVT Upper respiratory infection, COPD, Asthma. 1
0165115 01/23/2001 PA 7.0 2 .7 M 01/17/2001 This patient developed a diffuse rash over his body, varicella like. He required symptomatic treatment. Y 02/07/1996 01/09/2001 1798 NONE PVT PVT NONE NONE NONE ~Varicella (Varivax)~1~7.00~In Sibling|~Varicella (Varivax)~1~9.00~In Sibling 1
0165116 01/23/2001 PA 7.0 2 .7 F 01/17/2001 This patient developed diffuse rash (varicella) all over her body. She required symptomatic treatment. Y 02/07/1996 01/09/2001 1798 NONE PVT PVT NONE NONE NONE ~Varicella (Varivax)~1~7.00~In Sibling|~Varicella (Varivax)~1~9.00~In Sibling 1
0165117 01/23/2001 PA 9.0 4 F 01/17/2001 This patient developed diffuse rash, varicella like. She required symptomatic treatment. Y 02/07/1996 01/09/2001 1798 NONE PVT PVT NONE NONE NONE ~Varicella (Varivax)~1~7.00~In Sibling|~Varicella (Varivax)~1~7.00~In Sibling 1
0165118 01/23/2001 TX 4.0 4 F 01/15/2001 This patient has local redness and irritation at the injection site. Y 01/12/2001 01/14/2001 2 PVT PVT NONE Penicillin 1
0165119 01/23/2001 VA 35.0 34 F 01/10/2001 This patient was given vaccine 24 hrs ago. She took a nap this afternoon, woke with a 102 temperature (2:00 PM). On 01/18/01, the PMD reported positive Influenza A culture. The patients temperature went to 104 she saw the PMD, who felt the incident was coincidental that the patient had the flu. U 01/10/2001 01/10/2001 0 Temperature 104. PUB PVT PPD, Connaught, left arm sc, no previous doses, lot # Coo41AA. NONE 1
0165120 01/23/2001 MT 0.7 0 .7 F 01/16/2001 This patient had a temperature, after given Tylenol temp was 104.3. She was Hyporesponsive, inconsolably crying, and vomiting, it started at midnight on 01/13/01. The temperature stated before was in the ER at 2PM on 01/13/01. The mother reports the temperature was higher at home. Treatment included 2 baths, Tylenol at home with no response and a mineral bath in the ER. Y Y 01/12/2001 01/13/2001 1 NONE PUB OTH NONE NONE NONE 1
0165121 01/23/2001 AK 2.0 2 .1 F 01/19/2001 This child received the Varicella vaccine on 01/05/01. The mother noticed redness at the injection site beginning 01/10/01. The reddened area has increased and is now 5 cm in diameter. The child became fussy, and irritable, low grade fever, area of redness, is slightly firm with macular rash covering reddened area, also non tender. On 01/19/01, the patient is improving. U 01/05/2001 01/16/2001 11 NONE PUB UNK NONE NONE NONE 1
0165122 01/23/2001 WY 0.5 0 .5 F 01/05/2001 This infant has hypotonia spells four times the day following the immunization. Y 12/18/2000 12/19/2000 1 NONE PVT PVT Right otitis media. 1
0165123 01/23/2001 PA 17.0 16 F 01/15/2001 This patient had behavior changes, difficulty breathing, hives all over her legs, arms, and chest for a short period, paleness, weakness, very tired, dizziness occasionally, and fast heart beat. The doctor prescribed Beta Blockers, thinking it was an overactive thyroid. N 08/28/2000 09/04/2000 7 PVT PVT 08/28/00, PPD, Connaught,left forearm, interdermal, 1 previous dose, lot # C0041AA. NONE Exercise induced asthma. 1
0165145 01/24/2001 TX 0.2 0 .2 F 01/09/2001 Pt found in crib unresponsive and cyanotic baby. CPR started by EMS and transported to local hospital. Pt stayed in asystole even after 3 epi doses and 2 atropine CPR. Pronounced DOA at ER and medical examiners office notified and body transferred. Y 01/03/2001 N 12/29/2000 01/03/2001 5 Medical examiner's report-pending 6-8 weeks PVT PUB congestion NONE TX0101 1
0165146 01/24/2001 IA 4.0 4 M 01/10/2001 The mother described the pt having thrombocytopenia purpura following vaccination. He had a 2x2 inch purple bruise on the back of his right arm. The parents discussed this and decided a blood vessel must have been hit when the vaccine was given. After school started they began noticing more bruises. For awhile they attributed it to being a 4 year old and new playground equipment rough housing. The he started to get bruises in odd places like the stomach, face, and upper legs. We discussed this with preschool and daycare. After 2 months we decided to have a blood test done at our family doctor. The results were platelets 7,000. They were sent to another facility and once they were there the lab results were platelets - 2,000. We then had Win Rho administered. Since then we have had 9 more blood tests with up and down results. Per annual follow up last platelet was 22,000 in march 2002. Patient still bruises easily + cannot participate in the usually. activities(sports); telephone interview with mother. Annual follow up 10/29/2003: "Vaccine recipient did not recover from the adverse events. 07/09/2003: Platelet count 76,000; normal value 150-400,000." Y Y N 08/02/2000 08/02/2000 0 Labs abnormal PUB PUB NONE NONE IA01001 1
0165147 01/24/2001 MA 11.0 11 F 01/12/2001 On 9/12/00, had migraine headache, swollen glands, dizzy, nausea, constipation, lethargy, confusion, vomiting, obsessive behavior and abdominal pain. Treated with migranol, Reglan, Zyrtec, Rhinocort, Prilosec, Agoral. 60 day follow-up states the pt still has viral gastroparesis. Y Y N 08/31/2000 09/12/2000 12 CBC-Cat Scan-Upper GI-Digestive X-ray PVT OTH TB NONE allergies to dogs, cats, trees, grass 1
0165149 01/24/2001 PA 3.0 F 01/22/2001 A 3 year old female received an injection of Prevnar in 10/00 and subsequently, was admitted to the hospital with a dx of pneumonia and pleural effusion. As of 1/16/01, no further information was available. Fu info provides diagnosis of streptococcal septicemia. Y U 10/01/2000 Blood culture-"grew" pneumococcus OTH OTH UNK UNK UNK HQ6012317JAN2001 1
0165151 01/24/2001 MO 0.2 0 .2 F 12/26/2000 The pt experienced possible apnea 10-15 minutes post vax. The pt was sent home on an apnea monitor. Per F/U 4/9/01: The pt was admitted and placed on apnea monitor with no subsequent significant episodes of apnea or bradycardia. The family received CPR training. Her exam at discharge was within normal limits. She is to continue with apnea monitor and follow-up with MD. Y 1 Y 12/21/2000 12/21/2000 0 PVT PUB 1
0165152 01/24/2001 VA 0.75 0 .7 M 01/19/2001 The pt experienced a fever of 103 for 3 days, screaming, no sleep for 3 days, roseolla (rash on stomach) after four days. The pt developed autism, developmental delays with 9 month malabsorption. Y Y N 06/11/1998 06/11/1998 0 Auto Immune Disorder, Metabolic Imbalance, Leaky GUT, Malabsorption, Autistic Behaviors, high urinary peptide, yeast over growth. PVT PVT NONE NONE NONE 1
0165153 01/24/2001 VA 1.0 1 .0 M 01/18/2001 The pt experienced digestive system irregularities, malabsorption, diarrhea within weeks of vaccine. Loss of language, aloofness was also experienced within weeks of vaccine. 60 day follow-up states the pt has autism, leaky gut/gastrointestinal disorder. Y Y Y N 09/18/1998 09/18/1998 0 Oat, high citric, Vit C Deficiency, yeast over growth, urinary peptide. Diagnosed Autistic 12/2000. PVT PVT NONE NONE NONE Fever, screamin, and sleep disruption~DTP + Hib (no brand name)~3~0.00~In Patient 1
0165154 01/24/2001 FL 0.3 0 .3 M 01/15/2001 The pt experienced a sudden onset of fever to 101 on 1/11/01. The pt was presented to the office with a high pitched cry, temp of 102.7 and a bulging fontanel with poor eye contact. It was reported that the pt cried for more than 5 hours. Workup for meningitis was negative. He was admitted to the hospital. Diagnosed with possible reaction to immunizations Y Y 01/09/2001 01/11/2001 2 CSF Culture and Stain, Blood Culture. PVT PUB NONE NONE NONE 1
0165155 01/24/2001 MI 1.0 1 .0 M 01/15/2001 7 days post vax the pt developed a rash of about 6 spots that became blisters at about 10 days. The pt was not eating well, was vomiting had diarrhea lasting 3 days then coughing lasting about 2 days. On 1/11 the pt experienced a fever of 102.5 to 105.6 and was taken to the MD. On 1/12/01 had a seizure, was staring and wouldn't respond which lasted 2 minutes and went to the ER and was admitted to the hospital. Y Y Y 12/20/2000 12/27/2000 7 spinal tap, CBC, WBC-low PUB PUB NONE NONE NONE 1
0165156 01/24/2001 OH 0.08 0 .0 M The mom states that her son was "damaged" by the vaccines and every time she would report the event to the Doctor, she was told that the reaction was "normal". The child was born almost a month early during a 25 hour delivery. He was not jaundiced and she breast fed him at birth. He received his first vax the day after he was born. Following the hepatitis vaccine she reported that the infant was making some unusual sounds, almost like a little lamb. He continued to make these sounds when they went home from the hospital and he also began to have problems with diarrhea and constipation. Following each vax he became irritable, wouldn't sleep and would run a fever. The Doctor insisted this was normal. When he was 18 months old he slowly started regressing. He experienced a lump in his leg which the MD said would go away. When he was 2 years old he was diagnosed with PDD and then later they changed it to Autism. Y N 02/09/1994 PVT PVT ear and eye infection Premature 1
0165157 01/24/2001 MO 2.2 2 .2 M 01/16/2001 On 1/7/01, the child presented at this physician's office with a temperature of 103 and a papillary rash on arms, legs, and slightly on the trunk. Additional information was received stating that while the child was in the office he required two breathing treatments for his asthma and was found to have infiltrates in his lungs. The child has since been dx with pneumonia and a bacterial infection in the blood. Y U 01/03/2001 01/07/2001 4 OTH OTH NONE asthma MPI2001000170 1
0165158 01/24/2001 MD 3.9 4 F 12/15/2000 The pt was diagnosed with Kawasaki disease within 2 weeks of the varicella vaccine. 60 day follow-up states the pt still has an aneurysm. Some have disappeared but not the one leading into her heart. The follow-up indicates that,"the pt's problem is Kawakaki's disease complicated by mild coronary artery aneurysm. She is being treated with a second course of IVIg and high dose aspirin." Y Y N 10/26/2000 11/08/2000 13 PVT PVT NONE NONE 1
0165159 01/24/2001 GU 40.0 38 M The pt experienced a high fever and a sever headache within a few days following each shot. The headache was on and off from the 1st shot given. On 1/99 the pt was treated for end stage renal disease. Diagnosis also included severe hypertension. Y Y Y 3 Y N 11/12/1998 11/27/1998 15 MIL MIL high fever, severe headache NONE 1
0165160 01/24/2001 IL 1.08 1 .0 M 11/23/2000 The pt experienced a strange rash all over her body with a high fever which began lasted for 10-14 days. The pt experienced a speech delay and began speech therapy at the age of 2 1/2 and has been a very frustrated child with sensory difficulties and communication deficits. Y N 02/15/1997 02/26/1997 11 neurologist exam and diagnosis - speech apraxia and PDD autism PVT PVT Ceclor ear infection pneumothorax at birth, recovered ~Measles + Mumps + Rubella (MMR II)~1~1.00~In Sibling 1
0165161 01/24/2001 NC 0.5 0 .5 M 01/11/2000 The pt experienced urticaria on his face with edema of upper eyelids bilaterally and one hive on right leg. There was not airway compromise or breathing difficulty. Pt was given one dose of Benadryl and observed in the office. Y Y 01/08/2001 01/08/2001 0 PVT UNK NONE gastroesophageal reflux NC00002 1
0165162 01/24/2001 TX 4.0 4 M 12/27/2000 The pt experienced a rash to the face and neck, purpuric lesions, gave Benadryl 1 hour after vaccine when this appeared. (Most probably 2nd to forceful crying however not sure.) Y 12/20/2000 12/20/2000 0 PVT PUB NONE heart murmur TX00170 1
0165163 01/24/2001 5.0 5 U Two days post vax, the pt had puffiness and redness occurred at the injection site. Y 01/15/2001 01/17/2001 2 UNK UNK 1
0165164 01/24/2001 3.0 3 U Three days post vax the pt experienced redness and swelling at the injection site. Y 01/11/2001 01/13/2001 2 UNK UNK 1
0165165 01/24/2001 CA 0.3 0 .4 M 01/19/2001 The pt developed fine papular rash on the trunk and legs with increased redness at the leg injection site. Y 01/17/2001 01/18/2001 1 PUB PUB NONE NONE 1
0165166 01/24/2001 MI 0.9 1 1 F 01/19/2001 The pt broke out in hives around the injection site and then all over the body. The pt also experienced an erythematous urticarial lesion. Y 01/12/2001 01/16/2001 4 NONE PVT PVT NONE wheezing and colds 1
0165167 01/24/2001 NH 0.5 0 .5 M 01/18/2001 The same day of vax, the pt experienced crankiness and Tylenol was given. The pt was fretful during the night. The next day the pt experienced a fever and was treated with Tylenol. No further information or complaints. Y 01/15/2001 01/15/2001 0 NONE PVT PUB NONE NONE NH0102 1
0165168 01/24/2001 MA 1.0 1 .0 M 01/22/2001 The pt experienced a fever of 105.3 the same night of vax. Y 01/19/2001 01/19/2001 0 NONE PVT UNK Augmentin, Albuterol, Flovent asthma and sinusitis NONE 1
0165169 01/24/2001 WI 1.08 1 .1 F 01/18/2001 The pt experienced emesis, teeth grinding, clenching fists, flushing of cheeks, loss of attention. Symptoms resolved spontaneously. The pt had a febrile seizure. Y Y 01/08/2001 01/08/2001 0 WBC - 17000, all metabolic tests - nml, EEG - nml, stool culture - neg PVT PUB NONE NONE 1
0165170 01/24/2001 OR 33.0 32 M 01/10/2001 3 days post vax, the pt experienced a sore bump in the groin area which lasted for 2 weeks. The "bump" then disappeared. The pt has had a complete testicular and groin exam. No nodules and no tenderness were noted. Lymph node reactive process has resolved. Y Y 01/15/1999 02/23/2000 404 testicular and groin exam - nml MIL MIL NONE NONE pain lymph glands~Anthrax (no brand name)~1~32.00~In Patient 1
0165171 01/24/2001 TX 0.5 0 .6 F 01/17/2001 The pt experienced a vasculitis rash and edema of hands and feet. U 01/12/2001 01/13/2001 1 CBC - nml PVT PVT NONE NONE 1
0165172 01/24/2001 54.0 M 01/19/2001 The pt developed arthralgias and fatigue and was seen by his physician in July 1998. Treatment and outcome were not provided. U 05/01/1998 07/01/1998 61 Uric Acid - 6.3, Sed rate 3, monospot, rheumatoid factor, OTH OTH 20010013481 1
0165173 01/24/2001 HI 0.3 0 .4 F 01/17/2001 Approximately 38 hours post vax, the pt had difficulty breathing and was very fussy. The pt sounded like she was grunting. This lasted approximately 1 hour. Y 12/09/2000 12/10/2000 1 PVT PVT NONE NONE 1
0165174 01/24/2001 HI 0.2 0 .2 F 01/17/2001 Approximately 5 hours post vax, the pt made a funny noise. When the mother picked her up she became pale, and lips bluish. The pt resolved immediately. Y 10/07/2000 10/07/2000 0 PVT PVT NONE NONE 1
0165175 01/24/2001 VA M 01/17/2001 The pt experienced fatigue swollen hands, wrist and feet pain, low grade fever, night sweats, difficulty breathing, neck pain, hand tremor, bloodshot eyes, pleuritis, Treated with Doxycycline for 10 days prednisone, Prevacid, Voltaren and Ultram). the pt also experienced chest pain, and a restrictive feeling in throat. Y N 12/31/1999 03/01/2000 61 ANA - pos, rheumatoid factor - neg PVT PVT NONE joint pain in right shoulder 1
0165176 01/24/2001 WI 55.0 55 F 01/16/2001 Approximately 2 weeks post vax, the pt developed pain in hips, which migrated to shoulders, knees, and wrists. The pt awakened at night with pain. The pt has only one kidney due to renal carcinoma. Can't take NSAIDS N 04/07/1999 04/21/1999 14 bone scan - arthritis of left hip PUB PVT Premarin, Synthroid, Norvasc, Monopril, Lozol NONE renal carcinoma, hypertension, thyroid 1
0165177 01/24/2001 IA 0.8 0 .8 M 01/17/2001 The pt experienced a red, warm splotch approximately 7 CM across on right leg. Y U 01/15/2001 01/16/2001 1 NONE PVT PVT NONE URI NONE 1
0165178 01/24/2001 CA 0.3 0 .2 M 01/10/2001 Within 2 hours, the pt was inconsolable, screaming, afebrile. No local reaction at injection site. Screaming persists now 2 months later but more sporatic. Y 11/08/2000 11/08/2000 0 NONE PVT OTH NONE NONE 1
0165179 01/24/2001 NH 0.75 0 .8 M 01/17/2001 One day post vax, the pt had a fever, swelling of left leg, entire thigh. Was advised to apply heat and give Tylenol. Y 01/03/2001 01/04/2001 1 PVT OTH 1
0165180 01/24/2001 AL 1.25 1 .3 M 01/18/2001 The pt was seen in the ER on 1/17/01 with a rash and swelling. Was given Benadryl. Was seen in the clinic on 1/18/01 with isolated erythemic diffuse rash on right inner thigh and inguinal region. Given Atarax and cortaid cream. Pt also had acute gastroenteritis. Y Y 01/16/2001 01/16/2001 0 NONE PVT PUB NONE gastroenteritis NONE 1
0165181 01/24/2001 HI 32.0 32 M 01/07/2001 The pt experienced urticaria on face, back, neck and chest. Treated with meds. U 01/07/2001 01/07/2001 0 MIL MIL NONE 1
0165182 01/24/2001 MO 62.0 62 F 01/17/2001 The pt experienced right arm swelling, pain too bad to move. The next day, the arm was red and a rash appeared from shoulder to the elbow. Y 01/05/2001 01/05/2001 0 PUB PVT 1
0165183 01/24/2001 GA 36.0 36 F 01/17/2001 5 minutes post vax, the pt developed throat tightness, hot flushing, feeling faint, treated with epinephrine twice and also Benadryl and oral prednisone. Y Y 01/17/2001 01/17/2001 0 MIL UNK Flagyl bacterial vaginosis NONE 1
0165184 01/24/2001 OK 22.0 22 F 01/18/2001 The pt experienced a severe local reaction at the injection that was painful and with an 8 x 4 cm area of erythema and induration. Y U 01/16/2001 01/16/2001 0 UNK MIL MIL NONE allergy to azithromycin 1
0165185 01/24/2001 WI 49.0 49 F 01/10/2001 30 minutes post vax, the pt complained of site redness, swelling and itching. The area was 3cm x 2 1/2cm that was warm and elevated. No systemic symptoms. Lung are clear. Treated with Benadryl. Y 01/09/2001 01/09/2001 0 BP - 110/72, P-66 OTH PUB estrogen patch NONE NONE 1
0165186 01/24/2001 CA 55.0 55 M 01/17/2001 The pt experienced a high fever on 12/28/00 to 1/1/01, chest tightness and hard to breathe from 12/28/00 to 12/29/00. The pt experienced weakness from 12/28/ to 1/13, hoarseness from 12/29 to 1/5 and muscle aches from 12/28 to 1/5. Y 12/28/2000 12/29/2000 1 PVT UNK NONE NONE 1
0165187 01/24/2001 KY 68.0 68 F 01/17/2001 The pt experienced pain at the injection site which increased to pain of the entire right arm with swelling. That night had chest pain and the next day this became more severe with swelling of the face. 2 days later the pt developed swelling of the right neck, nausea, blurred vision with the right arm still aching. Y Y 01/08/2001 01/08/2001 0 PUB PUB allergy to sulfa, lupus, cirrhosis of liver, diverticulitis, asthma KY2001004 1
0165188 01/24/2001 WI 44.0 44 F 01/17/2001 15 hours post vax the pt went to the ER with upper back pain and chest pain. Heart and lungs were checked and were ok. Was told it was muscular pain most likely from the flu shot. Was given pain medication. Y Y 12/20/2000 12/21/2000 1 PUB PVT NONE 1
0165189 01/24/2001 TX 12.0 12 F 12/28/2000 This patient shot was given at 11:22 AM. The mother brought the patient to the office at 1:10 PM same day. The patient's left arm was swollen from the elbow to the shoulder, no tenderness, or warmth to the site, or redness. Y Y 12/28/2000 12/28/2000 0 NONE PUB PUB NONE NONE NONE TX00173 1
0165190 01/24/2001 TX 1.0 1 .3 F 12/20/2000 On 12/20/00, this infant had difficulty breathing, temperature of 100 at 1:00 PM, no other symptoms. Recommended to take the child to the ER immediately for further evaluation and treatments. Y U 12/18/2000 12/20/2000 2 PUB UNK On 12/18/00 two more vaccinations were given: DTAP (Tripedia), Connaught, lot # UO321BA, left leg, 4 previous doses; and IPV (Poliovax) Connaught, lot # T01612, left leg, 3 previous doses. NONE NONE TX00169 1
0165191 01/24/2001 ND 50.0 50 M 01/15/2001 This patient complains of pain in his left deltoid for 2 weeks after Tetanus injection. Also after 2 weeks pain in left shoulder going cross to the right shoulder. The patient was seen in the clinic on 12/27/00 with those complaints. No redness or swelling at the injection site on 12/27/00. The patient states pain comes and goes now. U 11/21/2000 12/05/2000 14 NONE PVT PUB Allopurinal, Lipitor, Vitamin E, Herbs Palmar - head dermatitis, neck shoulder strain after TD Gout, Back Pain, Diabetes. 1
0165192 01/24/2001 TX 14.0 14 M 09/25/2000 This patient states he woke up on 09/24/00 with a "lump" under his right arm and sore to move. No SOB, rash, or other symptoms, sickness or complaints. Able to touch top of head with that arm; 4-5 cm lymph node noted and right arm. No history of adverse reaction to shots in the past. Complains of cat in the house patient with a scratch. Y U 09/22/2000 09/24/2000 2 09/25/00 blood sent to TDH for Cat scratch fever, Toxoplasmosis, Parainfluenza. Temp 97.4, P 82, R 20, BP 120/80. PUB PUB NONE NONE NONE TX00165 1
0165193 01/24/2001 TX 53.0 53 F 12/14/2000 On 12/09/00, this patient had an onset feeling; feverish, broke out in a rash and had generalized joint pains. On the evening of 12/10/00, the rash extended to her face, chest, abdomen, and upper arms. She returned to work 12/14/00. Y 11/28/2000 12/09/2000 11 PUB PUB Climara patch (hormones) NONE NONE TX00167 1
0165194 01/24/2001 TX 11.0 11 F 12/08/2000 After the patient's 1st injection her arm was numb the next day. After the patient's 2nd injection her bottom lip swelled and was chapped. Y 11/30/2000 12/01/2000 1 PUB OTH NONE NONE TX00166 1
0165195 01/24/2001 TX 0.3 0 .4 M 12/19/2000 Within 5 - 10 minutes after administration of DTAP, HIB, and IPV; this child developed erythematous blotches on his lower extremities mainly one or so arms on the back. No welding noted, child fussy. Mother stated the child had similar effects after 2 month shots. Which faded shortly after they developed. Mother also states more areas this time. By 4:10 PM areas fading, advised to see a doctor. Y 12/19/2000 12/19/2000 0 PUB PUB NONE NONE NONE unspecified event~Vaccine not specified (no brand name)~1~0.00~In Patient TX00168 1
0165196 01/24/2001 TX 1.9 1 1 M 12/20/2000 After this patient's immunizations, about 9:45, the patient had an episode of staring, he would not respond to his name or touch, and he got listless. The EMS was called, the patient was taken to the ER. His episode lasted maybe 10 - 15 minutes. Upon arriving to ER the patient was more alert, crying, looking for guardian (grandmother). The patient was monitored all day and released from ER. The patient is to follow up with pediatric neurologist. As per grandmother the patient is doing well. Y Y 12/07/2000 12/07/2000 0 UNK PUB TX00171 1
0165197 01/24/2001 TX 72.0 72 F 01/04/2001 This patient states her left arm became very red and swollen after the vaccine. Her arm remained like that for a day. She states she was in a car accident and in the ER showed the doctors her arm. The doctors said they didn't think it was anything. They told her to see her private MD. She said she had not reported it to anyone else until now. She complained of not being able to lift her arm, sharp pain remains. U 10/30/2000 10/30/2000 0 OTH PUB NONE TX00172 1
0165198 01/24/2001 TX 1.25 1 .3 M 12/28/2000 This infant received vaccine in the left arm on 12/22/00. He has a 1/2 dollar sized round reddened area with red raised border to left shoulder with pinpoint area in the center. Received cold compresses, Motrin, and observed. Call back if not better, or becomes worse. Y 12/22/2000 12/28/2000 6 PVT PVT NONE NONE NONE 1
0165199 01/24/2001 NH 5.0 5 M 01/10/2001 This child's shot site was sore at the visit, 12 hours after the shot, he was febrile for 1 day, and his upper shoulder was red in a 3 inch area. Y 01/08/2001 01/09/2001 1 PVT OTH NONE 1
0165200 01/24/2001 FL 41.0 41 F 01/18/2001 This patient telephoned the office in mid afternoon complaining of face and chest redness and shortness of breath. She stated the sickness began approximately an hour after receiving her vaccine. She was instructed to report to the closest ER. She was treated and released from the hospital for an allergic reaction. Y Y 01/17/2001 01/17/2001 0 PUB OTH PPD, Connaught, intradermal, right arm, lot # 00143AB, 1 previous dose. NONE Allergic to Sulfa, Penicillin, Mangoes. Hypertension, Borderline Diabetes, Arthritis, and Mitral valve prolapse. 1
0165201 01/24/2001 FL 1.7 1 .2 M 01/12/2001 The patient's mother reports that the day after his vaccination the child developed a rash, and periorbital swelling. She also reported that the child stopped saying the few words he was already saying. The child wasn't brought to medical attention the day when these events occurred. The rash and periorbital swelling resolved. The child began to babble "mamma" a few days ago. There's family history of speech delay. Y 08/02/2000 08/03/2000 1 PVT PVT NONE NONE NONE 1
0165202 01/24/2001 CT 7.0 7 F 01/17/2001 Within ten minutes of this patient's vaccine, she developed facial hives and wheals. Y 01/16/2001 01/16/2001 0 PUB PUB Diluent Lot 1316K NONE Allergic to eggs and Rocephin. 1
0165203 01/24/2001 MO 7.0 3 F 01/18/2001 Vaccinated 1996. Failed chicken pox vaccine. Chicken pox 01/17/01. U 07/16/1996 01/18/2001 1647 PVT PVT 1
0165204 01/24/2001 MI 1.4 1 .4 M 01/17/2001 This child had an approximate 8 x 5cm circle of erythema with a mild lump left anterior thigh. U 01/15/2001 01/16/2001 1 PVT PVT 1
0165205 01/24/2001 MI 2.0 2 .8 M This child had an area 2 1/2 x 3 1/2 erythema initially, then it increased to 3 1/2 x 4 1/2, no itching at visit on 01/15/01. At visit on 01/17/01, redness greatly faded, still can see a shadow of reaction. Never complained of muscle pain. Treated with Keflex for 2 days. Y 01/12/2001 NONE PVT PVT NONE NONE NONE 1
0165206 01/24/2001 MI 0.3 0 .3 M 01/19/2001 At 9:30 PM this patient had stiffening of the body, tremulousness of the extremities, stare in eyes, and gray discoloration of face. The whole episode lasted for about 5 minutes. The patient was taken to the ED. His temperature 103.5 (rectal). No focus of infect found on exam. IM of vaciphen given. Y Y 01/18/2001 01/18/2001 0 CBC and Blood cultures done. (01/1901) WBC - 21,000. PVT PUB NONE NONE 1
0165207 01/24/2001 NC 26.0 26 F 01/12/2001 At 1 PM this patient complained of numbness and tingling of upper and lower extremities, with slight dizziness. BP 140/100 P 104. At 1:15 PM, signs and symptoms subsiding. BP 138/96, P 86. At 1:30 PM, no further complaints, the patient states she has history of high blood pressure. Advised to see her physician. At 2:15 PM, BP 120/88. Y 01/12/2001 01/12/2001 0 NONE OTH OTH Allegra NONE Allergic to Penicillin and Novocaine. 1
0165208 01/24/2001 NM 52.0 52 M 01/18/2001 This patient had his 2nd dose of Hep B given on 01/08/01. Development of subjective fever, malaise. weakness, headache, sweating, decreased appetite, pain in arm, somnolence, influenza-like illness, with shortness of breath, and tachypnea with congestion. On 01/09/01 (most severe) lasting 4-5 days. The patient did not seek medical care. Y 01/08/2001 01/09/2001 1 NONE PUB PUB Keflex for past 5-7 days. Dental root canal. Allergy to Sulfa drugs. 1
0165209 01/24/2001 CO 5.0 5 M 01/15/2001 This patient had a fever of 103.0 in the night, vomited 3 times. The patient's temperature down at doctors visit and taking fluids. The patient has a sore leg but walks on it, abscess a injection site, stomach ache and headache. Y U 01/12/2001 01/12/2001 0 ? Immunization reaction vs viral infection. PVT MIL Tylenol NONE Short stature 1
0165210 01/24/2001 CA 1.7 1 .8 F 01/18/2001 This child developed a diffuse morbilliform rash, 2 1/2 weeks after vaccine administered. U 01/05/2001 Physical Exam OTH UNK NONE Otitis Media NONE 1
0165211 01/24/2001 MI 1.0 1 .0 M 01/17/2001 This infant had a rash to his torso and shoulders, 12 days after his vaccinations. U 01/05/2001 01/17/2001 12 PVT PVT NONE NONE NONE 1
0165212 01/24/2001 NY 24.0 24 F 01/18/2001 This patient had redness, swelling, hot to touch, hard to touch, pain upon movement and erythema. 5 x 4 cm erythema, warmth induration of left shoulder. Treatment with Keflex, warm compresses and Ibuprofen. U 01/16/2001 01/16/2001 0 NONE UNK UNK Orthotricyclen NONE NONE 1
0165213 01/24/2001 KY 15.0 15 M 01/18/2001 This patient was given Hepatitis B, left deltoid at 2PM. Per mother the patient complained of symptoms of shortness of breath, throat closing, clammy, pale. Seen in ER given, IV fluids, and Benadryl at 6 PM; home at 9PM. Y Y 01/17/2001 01/17/2001 0 PUB PUB NONE NONE NONE KY2001003 1
0165214 01/24/2001 CO 1.2 1 .2 F 01/12/2001 The mother states the child is crying inconsolably all night. Temp 101.5, Tylenol given but no response. Went to pediatrician in AM on 01/09/01. The MD recommended for mom to continue Tylenol and fluids. The patient did respond to the Tylenol, temp decreased by the evening of 01/09/01. Normal by AM on 01/10/01. Y Y 01/08/2001 01/08/2001 0 PUB PUB NONE NONE NONE 1
0165215 01/24/2001 SC 0.2 0 .0 M 01/22/2001 Paleness 24 hours after injection of Hepatitis B vaccine a weeks old. Y 12/04/2000 12/05/2000 1 PVT PUB NONE 1
0165216 01/24/2001 NJ 1.25 1 .3 F This patient was seen in the ER 12/27/00, who had generalized seizure at home then later at ER had another seizure. Y Y 12/21/2000 12/27/2000 6 No EEG done - as per neurology. PVT UNK NONE 1
0165217 01/24/2001 CA 4.0 4 U This patient had a generalized maculo-papular rash on 12/28/00. After given vaccines on 12/22/00 afebrile , no shortness of breath. Y U 12/22/2000 12/28/2000 6 Ordered Rubeolla IgM, CBC, pt not done. PVT PVT NONE F/U on dog bite, had a tetanus shot before 12/20/00. 1
0165218 01/24/2001 IL 1.08 F 07/11/2000 A territory representative reported that a 13 month old female received an injection of Hib-Titer. Seven to 9 days post immunization, she developed an injection site reaction characterized by induration and redness. She recovered. This is 1 of 2 patients from this facility who experienced this event following receipt of Hib-Titer lot # 468-488. Y UNK OTH OTH UNK UNK UNK HQ6784202JUN2000 1
0165219 01/24/2001 WV 1.3 1 .3 F 07/11/2000 A physician reported that her 16 month old daughter received her fourth dose of Hib-Titer and Infanrix vaccines on 06/08/00. Twelve hours post immunization, she developed an injection site reaction characterized by redness, swelling, and warmth at the site of Hib-Titer administration. She was treated with Zyrtec and had "moderate" relief of the symptoms. Additional information received from the reporter indicated that the child developed a 13cm by 10cm area of erythema and induration at the Hib-Titer administration site. She recovered within 5 days. Y 06/08/2000 06/09/2000 1 UNK PVT PVT Iron NONE Colitis nos, food allergy. HQ7354414JUN2000 1
0165220 01/24/2001 IL 1.0 F 07/11/2000 A territory representative reported that a 12 month old female received an injection of Hib-Titer. Seven to Nine days post immunization she developed an injection site reaction characterized by induration and redness. She recovered. This is 1 of 2 patients from this facility who experienced this event following receipt of Hib-Titer lot # 468-488. Y UNK OTH OTH UNK UNK UNK HQ7584720JUN2000 1
0165221 01/24/2001 GA M 08/28/2000 A physician reported that a male received Hib-Titer and Infanrix vaccines and subsequently developed a fever of 103F. He also developed an injection site reaction characterized by swelling, erythema, warmth, and induration. The vaccine provider attributed these events to Hib-Titer administration. This report was received from Smith Klein Beecham (ref # INF 2000020973-1). U UNK OTH OTH UNK UNK UNK HQ8812421JUL2000 1
0165222 01/24/2001 DC U 08/08/2000 A physician reported that a patient received an injection of Hib-Titer and developed an immediate hypersensitivity reaction. No further info was available at the date of this report. MANUFACTURER'S COMMENT: The reporter indicated that 3 patients experienced this event, however; they are not presently identifiable. Additional reports will be generated when identifying information is provided. U UNK MIL MIL UNK UNK UNK HQ8436512JUL2000 1
0165223 01/24/2001 TX 1.5 1 .5 M 08/23/2000 A mother reported that her 17 month old son received vaccines on 01/17/00. He immediately developed an injection site reaction characterized by a 5 inch area of redness and swelling at the site of Hib-Titer administration. As of 07/19/00, the reaction had not resolved. U 07/17/2000 07/17/2000 0 UNK PVT PVT NONE NONE UNK HQ8879424JUL2000 1
0165225 01/24/2001 U 07/17/2000 A nurse reported that a child received a dose of DTaP and subsequently developed a fever of 106F. No further info was received at the date of this report. This report is considered medically important. The reporter declined to provide additional information and declined to grant permission for follow up. U UNK OTH OTH UNK UNK UNK HQ8586317JUL2000 1
0165226 01/24/2001 KS U 11/30/2000 A nurse reported that a patient inadvertently received Acel-Immune, instead of Td and the next day following immunization, developed an injection site reaction characterized by swelling and tenderness. This is 1 of 2 patients from this facility to experience this event following receipt of Acel-Immune lot # 462-355. Additional info received from product quality 08/21/00 indicated (from reporter) that the patient is "doing fine". Y UNK PVT PVT UNK UNK UNK HQ0058421AUG2000 1
0165286 01/24/2001 KS U 11/30/2000 A nurse reported that the patient inadvertently received an injection of Acel-Imune instead of Td on 8/15/00. The next day patient developed an injection site reaction characterized by swelling and tenderness. This is 1 of 2 patients from this facility who experienced this event following receipt of Acel-Imune lot 462-355. Additional information received 8/21/00 indicated that the patient was "doing fine." Y 08/15/2000 08/16/2000 1 UNK PVT PVT UNK UNK UNK HQ0164323AUG2000 1
0165287 01/24/2001 LA 2.0 2 .7 F Patient's mother reported that the patient received Acel-Imune, MMR (Merck), and IPV (Aventis Pasteur SA) vaccines on 8/31/99. Subsequently the patient began crying and screaming that lasted for hours. Later that evening, the patient developed a low-grade fever and stiffening of both legs. The stiffening of her legs caused her to awaken that night screaming. The low-grade fever and leg stiffness resolved within 5 days. On 9/5/99, the patient developed head pain. Copies of this report have been forwarded to Merck and Aventis Pasteur, manufacturers of the concomitantly administered vaccines. Y 08/31/1999 08/31/1999 0 UNK PVT OTH UNK UNK UNK WAES01010934 1
0165288 01/24/2001 NY 1.5 F 10/03/2000 A nurse reported that an 18-month-old female received Acel-Imune and IPC (Aventis Pasteur SA) vaccines on 7/11/00. On 7/14/00, the patient developed an injection site reaction characterized by redness, swelling and warmth at the site of Acel-Imune administration. She was seen by the physician and recovered. This is 1 of 3 patients from this facility who experienced this event following receipt of Acel-Imune lot 472-251. The reporter indicated that 7 to 8 patients experienced this event; however, only 3 are presently identifiable. Y Y 07/11/2000 07/14/2000 3 NONE PVT OTH NONE NONE UNK HQ1618529SEP2000 1
0165289 01/24/2001 NY 1.6 1 .6 M 10/03/2000 A nurse reported that the patient received Acel-Imune and Hib-Titer vaccines on 7/11/00. On 7/14/00, the patient developed an injection site reaction characterized by redness, swelling and warmth at the site of Acel-Imune administration. He was seen by the physician and recovered. This is 1 of 3 patients from this facility who experienced this event following receipt of Acel-Imune lot 472-251. The reporter indicated that 7 to 8 patients experienced this event; however, only 3 are presently identifiable. Y Y 07/11/2000 07/14/2000 3 NONE PVT OTH NONE NONE UNK HQ1618629SEP2000 1
0165290 01/24/2001 KY 50.0 50 M 08/09/2000 A nurse reported that the patient inadvertently received an injection of Acel-Imune on 5/30/00. He experienced pain at the injection site on 5/31/00. He recovered. Y 05/30/2000 05/31/2000 1 UNK PUB OTH UNK Cut on hand UNK HQ6672531MAY2000 1
0165291 01/24/2001 IA 5.0 U 07/31/2000 Nurse reported that the patient developed a fever and an injection site reaction characterized by redness and swelling. The patient recovered. This is 1 of 3 patients from this facility who experienced an adverse event following receipt of Acel-Imune lot 464-307. Y 06/01/2000 UNK PVT PVT UNK UNK UNK HQ6850605JUN2000 1
0165292 01/24/2001 NJ 0.75 0 .7 M 07/11/2000 Physician reported that the patient developed generalized urticaria and watery eyes 3 hours post vaccine. The patient recovered. Y Y 05/01/2000 05/01/2000 0 NONE PVT PVT UNK NONE Milk protein intolerance HQ7028207JUN2000 1
0165293 01/24/2001 NJ 0.2 0 .2 M 07/10/2000 Mother reported that within 24 hours of receiving vaccine, the patient became terrified, did not seem to recognize his mother, and screamed for approximately 9 hours. He then became very irritable and remained this way for a few days. The patient had a cold 1 week prior to immunization but had recovered by the date of immunization. The patient recovered. Copies of this report have been forwarded to Merck and Aventis Pasteur, manufacturers of the concomitantly administered vaccines. Y 04/05/2000 04/06/2000 1 UNK PVT OTH NONE NONE Nasopharyngitis HQ7128509JUN2000 1
0165294 01/24/2001 FL 0.3 0 .3 F 07/11/2000 Physician reported that patient developed screaming and irritability which persisted for approximately 24 hours. One day post immunization, the patient was seen by a physician and diagnosed with acute left otitis media. The patient was treated with antibiotics and the screaming and irritability resolved the next day. The patient recovered. A copy of this report has been forwarded to Aventis Pasteur, manufacturer of IPV. Y Y 03/09/2000 03/09/2000 0 UNK PVT PVT UNK NONE UNK Diarrhea~Pneumo (Prevnar)~~0.00~In Patient HQ7436416JUN2000 1
0165295 01/24/2001 DC 4.0 4 M 08/18/2000 Physician reported that one day post vaccine the patient developed an injection site reaction characterized by swelling, warmth and itching. The reaction extended from mid-thigh to the knee. The patient was seen by the physician and treated with diphenhydramine, cefprozil, and applications of cold compresses. The child recovered by 6/12/00. Y Y 06/07/2000 06/08/2000 1 UNK PVT PUB NONE NONE Asthma, allergy to amoxicillin, seafood allergy HQ7464116JUN2000 1
0165296 01/24/2001 IN U 07/06/2000 A territory representative reported that the patient developed an injection site reaction characterized by swelling and induration. The reaction occurred 2 to 5 days after administration and lasted for 3 to 5 days. The reporter indicated that 8 patients experienced this event following receipt of a few different lots of Acel-Imune; however, they are not presently identifiable. Y UNK PVT OTH UNK UNK UNK HQ7596720JUN2000 1
0165297 01/24/2001 IA U 08/28/2000 A healthcare professional reported that the patient developed swelling and a rash. The reporter indicated that 3 patients experienced this event; however, they are not presently identifiable. This is 1 of 2 reports from this facility of adverse events following receipt of Acel-Imune lot 464-307. Follow up states "Cancelled: Duplicate of #Q8380311JUL2000. U UNK OTH OTH UNK UNK UNK HQ7850326JUN2000 1
0165298 01/24/2001 NE 0.5 0 .5 F 08/18/2000 Nurse reported that on 7/5/00 the patient developed a red, raised abscess at the site of Acel-Imune administration. She was treated with cefadroxil. U 05/25/2000 07/05/2000 41 UNK PVT PVT NONE NONE UNK HQ8496113JUL2000 1
0165299 01/24/2001 IA 4.0 4 F 08/23/2000 A medical assistant reported that on 7/13/00 the patient developed an injection site reaction characterized by a "50 cent piece" sized area of redness, swelling, and warmth on the left thigh. This is 1 of 2 patients from this facility who experienced this event following receipt of Acel-Imune lot 470-527 or the concomitantly administered vaccine. A copy of this report has been forwarded to Merck, manufacturer of MMR. U 07/10/2000 07/13/2000 3 UNK PVT PVT NONE NONE UNK WAES00122046 1
0165300 01/24/2001 NY 1.5 1 .5 F 10/03/2000 A nurse reported that on 7/14/00 the patient developed an injection site reaction characterized by redness, swelling, and warmth at the site of Acel-Imune administration. She was seen by the physician and recovered. This is 1 of 3 patients from this facility who experienced this event following receipt of Acel-Imune lot 472-251. The reporter indicated that 7 to 8 patients experienced this event; however, only 3 are presently identifiable. Y Y 07/11/2000 07/14/2000 3 UNK PVT OTH NONE NONE UNK HQ8570117JUL2000 1
0165362 01/24/2001 IA 4.0 4 F 08/23/2000 A medical assistant reported that the day after receiving vaccines the patient developed an injection site reaction characterized by an 8 cm area of induration, warmth, erythema, and edema on the left thigh. On 7/10/00 she was seen by the physician. This is 1 of 2 patients from this facility who developed an injection site reaction following receipt of Acel-Imune lot 470-527 or the concomitantly administered vaccine. A copy of this report has been forwarded to Aventis Pasteur, manufacturer of IPOL. Y U 07/07/2000 07/08/2000 1 UNK PVT PVT NONE NONE UNK HQ8900324JUL2000 1
0165363 01/24/2001 OR 0.6 M 10/02/2000 A pharmacy employee reported that the patient developed swelling at the Acel-Imune injection site. He recovered. This is 1 of 3 patients from this facility who had an adverse experience following receipt of Acel-Imune lot 469-396. Y NONE PUB OTH UNK UNK UNK HQ8928124JUL2000 1
0165365 01/24/2001 OR 5.0 5 F 10/04/2000 A nurse reported that the day after receiving vaccines the patient developed a high fever and pain. She recovered. This is 1 of 3 patients from this facility who had an adverse experience following receipt of Acel-Imune lot 469-396 or the concomitantly administered vaccines. A copy of this report has been forwarded to Merck, manufacturer of MMR. Y 07/20/2000 07/21/2000 1 NONE PUB OTH UNK UNK UNK HQ9050227JUL2000 1
0165366 01/24/2001 IA 5.0 U 07/31/2000 Nurse reported that patient developed an injection site reaction characterized by redness and swelling. The patient recovered. This is 1 of 3 patients from this facility who experienced an adverse event following receipt of Acel-Imune lot 464-307. Y 06/01/2000 UNK PVT PVT UNK UNK UNK HQ9138728JUL2000 1
0165367 01/24/2001 IA 1.5 U 07/31/2000 A nurse reported that the patient developed an injection site reaction characterized by redness and swelling. The patient recovered. This is 1 of 3 patients from this facility who experienced an adverse event following receipt of Acel-Imune lot 464-307. Y 06/01/2000 UNK PVT PVT UNK UNK UNK HQ9138928JUL2000 1
0165368 01/24/2001 NY 1.5 1 .5 F A nurse reported that the day after receiving vaccines the patient developed an injection site reaction on the right arm characterized by redness, swelling, and pain. This is 1 of 3 patients from this facility who experienced this event following receipt of Acel-Imune lot 472-653. U 07/25/2000 07/26/2000 1 UNK PVT PVT NONE NONE UNK HQ9141528JUL2000 1
0165369 01/24/2001 NY 1.4 F A nurse reported that the day after receiving vaccines the patient developed an injection site reaction characterized by redness, swelling, and pain at the site of Acel-Imune administration. This is 1 of 3 patients from this facility who experienced this event following receipt of Acel-Imune lot 472-653. U 07/25/2000 07/26/2000 1 UNK PVT PVT NONE NONE UNK ~DTaP (Acel-Imune)~~0.00~In Sibling HQ9492607AUG2000 1
0165370 01/24/2001 NY 1.4 F 10/17/2000 A nurse reported that the day after receiving vaccines the patient developed an injection site reaction characterized by redness, swelling and pain at the site of Acel-Imune administration. This is 1 of 3 patients from this facility who experienced this event following receipt of Acel-Imune lot 472-653. U 07/25/2000 07/26/2000 1 UNK PVT PVT NONE NONE UNK ~DTaP (Acel-Imune)~~0.00~In Sibling HQ9492707AUG2000 1
0165371 01/24/2001 IN 2.0 2 .0 M A medical assistant reported that the day after receiving vaccines the patient developed a fever and vomited twice. He also developed an injection site reaction characterized by swelling and tenderness at the site of Acel-Imune administration. On 8/4/00, the patient was seen by the physician and diagnosed with "local reaction to vaccine." He recovered. A copy of this report has been forwarded to Aventis Pasteur, manufacturer of IPOL. Y Y 08/02/2000 08/03/2000 1 UNK PVT PVT NONE NONE UNK HQ9805214AUG2000 1
0165373 01/24/2001 GA 0.14 0 .1 F 09/21/2000 Mother reported that the patient received her first dose of DTaP in February, 1999, and 48 hours later, she developed a "hypotonic reaction." The patient was seen by the pediatrician. Her symptoms resolved within 8 hours. Y 02/01/1999 02/03/1999 2 Blood cultures PVT PVT NONE NONE UNK HQ0050421AUG2000 1
0165374 01/24/2001 VA U A territory representative reported that the patient developed a large amount of swelling at the injection site. The patient was treated with antibiotic. The reporter indicated that 2 patients experienced this event; however, they are not presently identifiable. U UNK PVT OTH UNK UNK UNK HQ0422929AUG2000 1
0165375 01/24/2001 CA 0.3 0 .3 F Physician reported that patient received vaccine on 2/8/00, and approximately one week post immunization, she developed a lump at the injection site. This report was received from Aventis Pasteur (Ref. No. U2000-00357 (0)). U 02/08/2000 02/15/2000 7 UNK OTH OTH UNK UNK HQ6920306JUN2000 1
0165376 01/24/2001 IN 7.0 7 U Medical assistant reported that within 24 to 48 hours post immunization the patient developed an injection site reaction characterized by a red, warm, hard welt at the site of Acel-Imune administration. This is 1 of 6 patients from this facility who experienced this event following receipt of 3 different lots of Acel-Imune. U 05/02/2000 05/03/2000 1 UNK PVT OTH NONE NONE UNK HQ6930506JUN2000 1
0165377 01/24/2001 IN 4.0 4 U Medical assistant reported that within 24 to 48 hours post immunization the patient developed an injection site reaction characterized by a red, warm, hard welt at the site of Acel-Imune administration. This is 1 of 6 patients from this facility who experienced this event following receipt of 3 different lots of Acel-Imune. U 05/30/2000 05/31/2000 1 UNK PVT OTH loratadine NONE UNK HQ7240313JUN2000 1
0165378 01/24/2001 IN 2.8 2 .9 U An MA reported that a 34 month old child received Acel-Imune and Prevnar vaccines on 5/2/00 and within 24 to 48 hours, post vax, the child developed an injection site reaction characterized by a red, warm, hard welt at the site of the Acel-Imune administration. This is 1 of 6 pts from this facility who experienced this event following receipt of 3 different lots of Acel-Imune. U 05/02/2000 05/03/2000 1 UNK PVT OTH azithromycin NONE UNK HQ7240413JUN2000 1
0165379 01/24/2001 IN 0.6 0 .6 U An MA reported that a 7 month old infant received Acel-Imune, Prevnar and Hep-B vaccines on 5/24/00 and within 24 to 48 hours, post vax, the infant developed an injection site reaction characterized by a red, warm, hard welt at the site of the Acel-Imune administration. This is 1 of 6 pts from this facility who experienced this event following receipt of 3 different lots of Acel-Imune. U 05/24/2000 05/25/2000 1 UNK PVT OTH UNK NONE UNK HQ7240513JUN2000 1
0165380 01/24/2001 IN U An MA reported that a child received Acel-Imune, Prevnar, Hib and Varivax vaccines on 5/25/00 and within 24 to 48 hours, post vax, the child developed an injection site reaction characterized by a red, warm and hard welt at the site of the Acel-Imune administration. This is 1 of 6 pts from this facility who experienced this event following receipt of 3 different lots of Acel-Imune. U 05/25/2000 05/26/2000 1 UNK PVT OTH UNK NONE UNK HQ7240613JUN2000 1
0165382 01/24/2001 IA 5.0 U 08/18/2000 Nurse reported that the patient developed an injection site reaction. This is 1 of 2 reports from this facility of adverse events following receipt of Acel-Imune lot 464-307. U 06/14/2000 UNK OTH OTH UNK UNK UNK HQ8380311JUL2000 1
0165383 01/24/2001 VA 4.0 4 M 07/27/2000 Nurse reported that on 7/22/2000 the patient developed an area of warmth measuring 3.5 inches and described as the size of a "baseball" at the site of Acel-Imune administration. On 7/25/2000, the same area measured 2.5 inches. No treatment recommendations were made by a physician. U 07/20/2000 07/22/2000 2 UNK PVT PVT NONE NONE Allergy to cephalexin HQ9022126JUL2000 1
0165384 01/24/2001 IN U 07/31/2000 A company representative reported that the patient developed a local reaction at the injection site. The reporter indicated that 5 patients from this facility experienced this event; however, they are not presently identifiable. U UNK OTH OTH UNK UNK UNK HQ9091227JUL2000 1
0165385 01/24/2001 LA F 10/02/2000 Nurse reported that the patient developed a "severe" injection site reaction characterized by tenderness and a welt measuring 3 to 4 inches at the site of the Acel-Imune immunization. This is 1 of 2 patients from this facility who experienced this event following receipt of Acel-Imune lot 467-674. U 07/29/2000 UNK PVT OTH NONE UNK UNK HQ9346202AUG2000 1
0165386 01/24/2001 IN U 08/15/2000 A company representative reported that several patients developed "excessive" redness at the injection site between 7/24/00 and 7/26/00. The reporter was unable to specify the number of patients who experienced this event. U 07/24/2000 UNK PVT OTH UNK UNK UNK HQ9516207AUG2000 1
0165387 01/24/2001 LA F 10/02/2000 Nurse reported that the patient developed a "severe" injection site reaction characterized by tenderness and a welt measuring 3 to 4 inches at the site of the Acel-Imune immunization. This is 1 of 2 patients from this facility who experienced this event following receipt of Acel-Imune lot 467-674. U 07/29/2000 UNK PVT OTH NONE NONE UNK HQ9528307AUG2000 1
0165388 01/24/2001 MN 0.4 0 .5 M Nurse reported that within 24 hours the patient developed vomiting. Copies of this report have been forwarded to Merck, manufacturer of MMR II and Comvax and Aventis Pasteur, manufacturer of IPV. Additional information received 9/5/00 indicated that the patient recovered. Y 08/15/2000 08/16/2000 1 UNK PVT OTH NONE Runny nose UNK HQ9972117AUG2000 1
0165227 01/25/2001 PA 27.0 27 F 09/21/2000 The pt experienced right hand twitching in July and August. After November, the right arm had weakness until April, it was useless. The pt also experienced weakness in the right leg and left arm. Handtwitched. Vaccinated 1 in May, 2 in June > July and Aug. Vaccinated Nov 30, 1999, right shoulder shows weakness leading to complete useless by April 2000. Y U 11/30/1999 EMG, blood and urine test, MRI MIL MIL NONE NONE 1
0165228 01/25/2001 NJ 4.0 4 F 01/22/2001 The patient has an itchy, red bump around the injection site 01/19/01. No fever, size 4x9cm. Treated with Tylenol and Benadryl. Y 01/18/2001 01/20/2001 2 NONE PVT PVT NONE NONE NONE 1
0165229 01/25/2001 VA 42.0 42 F 01/19/2001 Three days after the patient received vaccine she started with extreme fatigue, fever, pain in joints, fibromyalgia, shortness of breath. The patient became bedridden for 2 weeks, she visited the ER with severe pain through out her body. Y U 12/29/2000 01/01/2001 3 PVT OTH Lyme Disease, Heart palpitations Lyme disease 1
0165230 01/25/2001 AZ 42.0 68 F 01/18/2001 The patient developed "leg cramps" thighs and calves bilateral 7 days following Influenza vaccine. The pain was relieved by Darvocet, persists 1/18/01. U 12/28/2000 01/04/2001 7 NONE PUB UNK Vitamin E, Tums, Glucosamine, Chondroitin, multiple vitamins, Premarin, Pepcid, Synthroid. Continuous leg cramps Hypothyroid, Osteoporosis 1
0165231 01/25/2001 IL 24.0 24 F 12/04/2000 The patients arm was sore 4-5 days after vaccine, 11/30. It began to hurt again to touch or lifting arm above head. The patient continues today 12/04/00. Prescribed Tylenol; the site with out warmth, redness, or edema. Did notice 15 minute episode of tingling in fingers. Y N 11/21/2000 11/30/2000 9 OTH PVT NONE NONE Latex gloves 1
0165232 01/25/2001 OH 65.0 65 M 01/17/2001 This patient under went a total knee arthroplasty 12/06/00. Prior to receiving the vaccine on 12/07/00 his temperature was 101F. Two hours after the vaccine his temperature was 102F. Two and a half (2 1/2) hours after the vaccine his temperature was 105F. The patient was confused and experienced nausea and vomiting. Preadmission testing done prior to surgery revealed normal CBC and urinalysis, blood cultures done at 6:50 PM were positive for E.coli. The patient was treated with IV Rocephin and was released to home 12/09/00. Y 12/07/2000 12/07/2000 0 CBC and urinalysis - Nml. Blood cultures - positive for E.coli. PUB UNK No known allergies. Positive for arthritis, decreased thyroid disease. 1
0165233 01/25/2001 MD 56.0 56 F 01/18/2001 The patient has pain in injection site since shot was given, no redness or swelling. Y N 11/02/2000 11/02/2000 0 PVT PVT Atenolol, Prilosac Left arm pain x 2 mos Hypertension, "borderline" Diabetic, "borderline" Lupus 1
0165234 01/25/2001 VA 51.0 51 M 01/16/2001 This patient had vaccine administered 01/09/01 at 1:45 PM. The client noted red , slightly raised rash on knees and arms. On 01/11/01 he also noted "pimplish" rash on thighs and calves, lymph nodes "inflammed", no temperature noted. History of cold one week prior to Christmas, progressed to sinus infection. Last dose of Amoxicillin was 01/05/01. Took Pseudoephedrine on 01/09/01 and 01/10/01. Y Y 01/09/2001 01/11/2001 2 NONE PUB PUB Lipitor, Allopurinol. Last dose of Amoxicillin 01/05/01. Recovering from sinus infection Allergic to bee stings, Hay fever, History of High Cholesterol, history of gout VA01002 1
0165235 01/25/2001 AL 70.0 70 F 10/20/2000 This patient was given the Flu vaccine in the left deltoid and Pneumovac in the right deltoid approximately 9:55 AM on 10/10/00. Within 3-5 minutes after injections the patient complained of bilateral sites of injection itching. There was a red area at the site of the Flu vaccine quarter size. Red area 1 1/2 inch at the site Pneumovac injection. The patient states "sometimes my skin is more sensitive than other", she also states "I feel fine". The patient went to see his physician who ordered ice to be applied, Benadryl 25 mg given as ordered, 2nd Benadryl 25 mg to take 4-6 hours later. Y 10/10/2000 10/10/2000 0 PVT UNK Ativan, Provera, Tylenol, Estrace, Fioricet, Keflex, Levsin, Atenolol. Patient complains of history of arm discomfort~Tetanus Toxoid (no brand name)~~0.00~In Patient 1
0165236 01/25/2001 MO 1.0 1 .0 M 01/17/2001 The pt experienced malaise, then the pt suddenly stiffened and had an odd look in the face and was unresponsive. The pt's face became pale and he experienced perioral cyanosis. 12-13 minutes later the pt acted normally and was taken to the ER. The pt had a fever of 104. Y Y 01/12/2001 01/13/2001 1 NONE PVT PVT NONE hypospadias 1
0165237 01/25/2001 NJ 30.0 29 F 01/22/2001 10 days post vax the pt experienced severe body ache, low grade fever with chills for 3 days and then rash for 3 days. Y 12/18/2000 12/28/2000 10 UNK PVT NONE NONE NONE 1
0165238 01/25/2001 OH 1.0 1 .0 F 01/20/2001 The pt experienced a rash to the back, neck and chest, erythematous, maculo-papular and diffuse. U 01/11/2001 01/19/2001 8 NONE PUB PVT blister on foot 1
0165240 01/26/2001 MD 65.0 65 M 01/19/2001 The pt developed Guillain Barre on 12/10. Was admitted to the hospital and remains hospitalized. On 1/23/01 the prognosis for a full recovery in 2 years. Was transferred to a rehab unit on 1/16/01. Also diagnosed with sleep apnea. Follow up on 07/09/2001: "Chronic illness before includes chronic heart disease, sleep apnea, atrial fib. " Y Y Y Y N 12/05/2000 12/10/2000 5 OTH PVT Coumadin, Lanoxin, Prinivil, Zocor NONE MI with angioplasty, endocarditis, atrial fib, HTN, CAD 1
0165241 01/26/2001 GA 0.6 0 .4 M 01/22/2001 The pt became very fussy around 1:00 PM on 10/29. He would not open his eyes, was very limp and left leg would shake uncontrollably. He had a blood blister on the right side of tongue. The pt was taken to the ER. Y Y Y 16 Y Y 10/23/2000 10/29/2000 6 PVT PVT runny nose Infant was 2 months premature 1
0165243 01/26/2001 MD 18.0 M 01/19/2001 In November 1999, the pt had a bilateral lung transplant. He was administered immunosuppressive therapy. In January 2000, the pt experienced viral pneumonia. In May 2000, the pt experienced pneumococcal pneumonia. On 10/2/00, bronchoalveolar lavage revealed heavy filamentous organisms in 3 of the 4 tubes. On 10/5/00, the pt experienced decreased pulmonary function with a decline in forced expiratory volume and bilateral pleural effusions. The pt was hospitalized from 10/5/00 to 10/13/00. He was placed on itraconazole. On 10/18/00, the pt developed nonpainful lesions on the shaft of his penis and buttocks. None of the lesions appeared secondarily infected. He was placed on Augmentin. The lesions formed a confluent patch on his skin on other parts of the body. On 10/20/00, it was noted his energy level was 30%. There was no fever, and skin lesions were vesicular appearing, but did not hurt or itch. There were multiple vesicular lesions, many of which were on an erythematous base. They were scattered in multiple dermatomes on the face, neck, arm, back, chest, and upper thighs. The physician was not sure if the pt experienced reactivation of the vaccine strain virus or breakthrough wild type chickenpox. Subsequently the pt recovered. There was an uncomplicated recovery with crusting of lesions on acyclovir. The pt had no history of chickenpox. There was no recent exposure to wild-type varicella preceding his breakout. Y 9 Y 11/01/1999 tissue analysis-VZV positive UNK UNK Tylenol, albuterol, Benadryl, Cellcept, Prilosec, prednisone, Actonel, Bactrim, magnesium oxide bronchopulmonary dysplasia, prematurity, respiratory condition, drug allergy WAES01010434 1
0165244 01/26/2001 MD 1.25 1 .3 F 01/19/2001 On 12/26/00, the child was admitted to the hospital. At the time of admission the child apparently had 2 lesions, though at the time of admission, the significance of the lesions was not noted. The child also had a fever of 102. On 12/26/00, the pt was placed on the combination of vancomycin and piperacillin/tazobactam. Cultures from the central line were positive for Coag negative staph sensitive to oxacillin. A culture from the draining PEG grew methicillin resistant staph aureus. By 12/28/00, the child had developed at least 50 generalized lesions and was started on IV acyclovir. After 12/28/00, the child gradually developed small crops of lesions predominately on the extremities and in the diaper area. On 12/28/00, the child had a pediatric ID consultation. The physician noted that the child in general was alert and in no distress and was able to walk. Her height and weight were greater than 95% for her age. The child suffered from alopecia. Extraocular movements were intact. Red reflexes noted bilaterally. The sclarae are anicteric. Tympanic membranes were gray and had a normal light reflex. The pt had mild nasal congestion and a small amount of nasal discharge. There were no oral lesions and the pharynx was benign. Her neck was supple. The pt's abdomen was soft and somewhat distended, occasional bowel sounds were noted. A PEG button was in place and there was some crusting but no drainage. There were numerous vesicular lesions scattered throughout her skin and were located in the extremities on the torso, on the scalp and most prominently in the area of the diaper. In total there were approximately 40-50 lesions which appeared to be at various stages. A few were crusted over, others had a more vesicular appearance. The pt's cranial nerves were intact. The pt was found to be VZV positive. As of 1/4/01, the physician indicated that the child is clinically stable and appears to be doing well. The physician indicated the child had a generalized vesicular rash, classic for varicella. It is probable that the varicella is secondary to the administration of the live viral vaccine to and immunocompromised child. A particular concern is the rising transaminases which appear temporally correlated with the administration of the vaccine. This may indicate a dissemination of the varicella. No further information is available. Follow-up info received from a physician on 4/24/01, indicated that as the pt was discharged from the hospital and has recovered from her experiences. He indicated that he is no longer following her as an outpatient. The physician reported that since 1/01, the pt has been followed in an outpatient clinic at the hospital for her autoimmune enteropathy. The records indicate she is doing well at home and has not been on any antiviral agents or had any sequelae from her adverse experiences in 1/01. The physician stated that according to hospital records, lesion specimens on 12/20/00 and 1/2/01 were positive for varicella; however, he could find no record that any PCR was done to differentiate between wild-type or vaccine strain VZV. No further information is available. Y Y Y Y 12/08/2000 12/26/2000 18 abdominal ultrasound - stones in gallbladder, Chest x-ray - nml, blood cultures - neg, Hep B, Hep C, ESV - all nml, blood culture - pos for staph, serum alanine - 71, 198, serum albumin - 3.9, serum alkaline - 329, serum aspartate - 378, 501, 196, 189, 94, serum alkaline - 368, 407, 419, wound culture - pos, staph, WBC count - 8.0, UA - neg, serum protein - 6.5, temp - fever, serum alkaline - 256, hemoglobin - 7.8, bilirubin - 1.4, platelet count - 330 OTH OTH UNK anemia, bacterial sepsis, neutropenia, seizure, blood transfusion, alopecia, intractable diarrhea which was eventually dx'd auto-immune enteropathy; hepatic function abnormality WAES01010415 1
0165246 01/26/2001 NC 1.5 2 .5 F 01/05/2001 The pt experienced a 3 1/2 cm x 4cm are of erythema and a 2 x 2 cm area of induration surrounding the injection site. Y Y 01/03/2001 01/04/2001 1 PVT PVT NONE NONE NC00004 1
0165247 01/26/2001 CA 1.0 1 .0 U 10/27/2000 The pt experienced possible hives on face. Treated with Benadryl and went away. The pt also experienced a fever of 101. On 10/30/00 5 days post vax, the hives returned. The pt was referred to an allergy clinic. Y N 10/25/2000 10/26/2000 1 PVT PUB albuterol NONE 1
0165248 01/26/2001 TN 23.0 23 F 01/18/2001 The pt experienced redness, slightly swollen area with welts. States arms are sore, and chest is red. Y 01/18/2001 01/18/2001 0 NONE PVT UNK NONE NONE allergies 1
0165249 01/26/2001 MN 60.0 60 M 12/05/2000 The pt experienced left sided bells palsy Y Y 11/21/2000 11/22/2000 1 PVT OTH Ibuprofen, Vioxx NONE recurrent cellulitis swelling, clamminess~Vaccine not specified (no brand name)~1~20.00~In Patient 1
0165250 01/26/2001 CO 14.0 14 M 11/18/2000 The pt experienced a 20 second seizure seven hours post vax. Y 11/18/2000 11/18/2000 0 CT scan - nml, EEG, nml PVT OTH NONE seizures NONE 1
0165251 01/26/2001 LA 4.0 1 .0 F 01/24/2001 No data provided. Y 01/07/1998 01/14/2001 1103 PVT PUB TB test NONE hx of bronchitis 1
0165252 01/26/2001 VA 35.0 35 F 01/17/2001 3 days post vax, the pt experienced right arm soreness, hot to the touch, welts and swelling from the injection site to elbow, redness and itching. Complaint continued from 1/6/01/ through 1/12/01. The pt saw her PMD and was treated with Aleve and Allegra. Y Y 01/03/2001 01/06/2001 3 PUB PUB NONE NONE allergy to Phenergan VA01003 1
0165253 01/26/2001 CA 50.0 50 F 01/28/2001 Approximately 5 minutes post vax, the pt complained of hives, itching to both arms. The pt was treated with Benadryl. Approximately 15 minutes later the pt stated the itching has decreased. Y 01/23/2001 01/23/2001 0 NONE OTH PVT Atrovent, Naproxen, Catapres, Darvocet COPD and tobacco use allergy to several drugs 1
0165254 01/26/2001 CO 0.5 0 .5 M 01/17/2001 The pt had five mild seizures in the five days following the vax. He could not hold up his head/back. He looked "out of it", was unresponsive and then cried. Each episode lasted 30-60 seconds. The seizures started with strong breathing. Y 12/08/2000 12/09/2000 1 EEG - nml PVT UNK Tylenol atopic dermatitis 1
0165255 01/26/2001 ND 70.0 70 M 01/17/2001 The pt experienced redness which was 2 inches in diameter around the injection site with limited amount of swelling. Suggested using Advil for inflammation and using ice and cold packs for 24 hours. Was seen in ER on 1/17 Y Y 01/16/2001 01/16/2001 0 PVT PUB NONE NOEN 1
0165256 01/26/2001 DE 10.0 M 01/22/2001 The pt experienced convulsions, crying, high pitched screaming, ear infections, and ER visits. Treated with antibiotics. Y N diagnosed with autism UNK UNK NONE NONE 1
0165257 01/29/2001 WA 0.2 0 .2 F 01/23/2001 Within 7 hours post vax, the infant developed tachycardia. She was taken to the local ER and hospitalized for observation. She recovered and was discharged. Y Y 3 Y 01/08/2001 01/08/2001 0 CBC wnl; csf analysis wnl; urinary analysis wnl; blood cultures wnl; sepsis ruled out PVT PUB prematurity 20010017461 1
0165262 01/29/2001 FL 0.5 0 .5 U 01/24/2001 One day post vax, the child was hospitalized for erythema multiforme over the entire body. The child is being treated with Solu-Medrol therapy. The week prior to this event, the child received therapy with Augmentin for the treatment of an ear infection. Y U 01/17/2001 01/18/2001 1 UNK PVT OTH Augmentin ear infection HQ6209322JAN2001 1
0165263 01/29/2001 NC 51.0 51 F 01/24/2001 One day post vax, the pt developed flu-like symptoms and had pain on the right side of her chest. The pt noted that she then went to to an emergency facility where she was diagnosed with severe bacterial pneumonia that was confirmed by cultures. She spend 9 days in the hospital where she received unspecified IV antibiotics. Therapy was switched to Keflex for 10 days once she was discharged from the hospital. ON 1/15/01, the pt returned and was subsequently diagnosed with inflammation of the pleural cavity. She was discharged. F/U her admitting dx were R upper lobe pneumonia, COPD and asthma. The pt recovered. The hospital physician did not consider this event to be secondary to vaccine administration. Y 9 U 12/20/2000 12/21/2000 1 UNK F/U CBC w/diff, blood gases, blood chemistry, urinalysis, blood and sputum clutures anc chest x-ray were performed. WBC -4,7000 K/UL arterial blood gas results were pH at 7.477,pCO2 at 22.5 mm/mg, pO2 at 67.9 mm/hg, HC03 at 16.3 Meq/l (22-26) with a base excess at -5.0 and oxygen sat at 95.1% on room air. urinalysis revealed a high level of bacteria, chest x-ray showed R upper lobe consolidation with honeycombin of the lung which may have been secondary to active to TB or other bacterial infections. PPD was performed, however results were not provided. PVT PVT Serevent, Vioxx, Klonopin, Prempro, Tylenol NONE asthma, emphysema, cough, diverticulitis, drug hypersensitivity, intervertebral disc degeneration, osteoarthritis HQ6270423JAN2001 1
0165264 01/29/2001 NC 0.5 0 .3 M 01/17/2001 The pt was irritable the day of the vaccines with a breath holding spell at home and became pale. The pt also experienced a low grade fever of 100.4. Y Y 11/02/2000 11/02/2000 0 PVT PUB NONE NONE NONE NC00003 1
0165265 01/29/2001 NC 1.0 1 .1 M 01/14/2001 The pt came in for a well visit on 1/12/01, received vaccines. Immediately after the vaccine, the child developed an erythematous rash on the face and extremities and a petechial rash on neck. Benadryl was given and within 45 minutes the child was fine. No swelling or redness to the leg. Y 01/12/2001 01/12/2001 0 PVT OTH NONE NONE hx of wheezing NC00005 1
0165266 01/29/2001 NY 0 .7 F About 12 hours post vax the pt developed urticaria and had resolved by morning. The pt was given Benadryl every 4 hours. Y 01/18/2001 01/19/2001 1 NONE PVT PUB Albuterol, Intal candida diaper rash, mile cough asthma, dermatitis 1
0165267 01/29/2001 GA 54.0 53 F 01/14/2001 The pt experienced joint pain, swelling, fever, and headaches. The pt had a rash after the shot the next day. Y U 07/28/1999 07/28/1999 0 ANA - neg, rheumatoid factor - neg PUB PUB Cardizem NONE high blood pressure 1
0165268 01/29/2001 NY 27.0 27 F 01/11/2001 The pt experienced generalized itching and rash. Some swelling was reported on the day after vax. On 1/11/01 the pt's extremities noted to be flushed and slightly erythemic with blanching on pressure. The pt is taking Benadryl with some relief. States previous vaccine had no adverse event. Y 01/10/2001 01/10/2001 0 NONE PUB PUB NONE migraines 1
0165269 01/29/2001 NY 68.0 68 M 01/17/2001 The pt complained of hives over 80 percent of body which appeared approximately 10 hours post vax. The pt used Benadryl cream and symptoms subsided. The next day the hives returned. The pt saw an MD and was diagnosed as a drug allergy. The MD prescribed Benadryl and Claritin. The pt was called and his only complaint then was edema of the lips and hands. Y Y 01/16/2001 01/16/2001 0 PUB PUB NONE sinus problems, heart bypass NC00006 1
0165270 01/29/2001 NY 64.0 64 M 11/15/2000 The pt experienced achiness, stomach pain, all over aches has heart problems, mild temp, pounding headaches. No diarrhea or vomiting. Went to the ER and was checked for heart problems. The pt has had a previous heart attack and thought was flu. The pt is on Cefcil, Flonase for 7 days. Y 11/01/2000 11/04/2000 3 Blood work, EKG OTH PVT Coumadin, Vasotec, Lasix, Lipitor NONE NONE flu symptoms~Tetanus Toxoid (no brand name)~1~40.00~In Patient 1
0165271 01/29/2001 NY 59.0 59 F 11/07/2000 The pt experienced body aches, severe soreness in the right armpit, slight elevated temp, tiredness, took Tylenol and was better the next day. Y 11/04/2000 11/05/2000 1 NONE OTH PVT estrogen therapy NONE allergy to sulfates and some foods 1
0165272 01/29/2001 NY 46 F 11/10/2000 The pt complained of joint pain at the shoulder, elbow, wrist. No redness or swelling. The pt hasn't taken anything. Took ibuprofen over the weekend and was better on Monday. Y 11/10/2000 11/11/2000 1 NONE OTH PVT synthroid, Cardizem NONE arthritis 1
0165273 01/29/2001 NY 71.0 71 M 12/14/2000 The pt complained of a sore arm, chills, achy joints, temp of 100. Tylenol was recommended. U 12/12/2000 12/12/2000 0 OTH UNK NONE 1
0165274 01/29/2001 NY 57.0 57 F 12/13/2000 The pt felt weakness, headache, diaphoresis following the vax. The pt was still not well on the following day. It was suggested that she call her MD. U 12/12/2000 12/12/2000 0 OTH UNK Wellbutrin, Depakote NONE 1
0165275 01/29/2001 NY 66.0 66 M 11/10/2000 The pt experienced night chills, no fever, chest congestion, dry cough. Sweats lasted 2 days. Took Advil regularly. A little better now. Y 11/06/2000 11/06/2000 0 NONE OTH PVT Lipitor, HCT, Prinivil NONE NONE 1
0165276 01/29/2001 NY 80.0 80 F 11/08/2000 The pt complained of arm itching, area red and raised where injection given. Had an MD appt. Said to observe and call if it gets bigger. No temp. Y 11/01/2000 11/02/2000 1 NONE OTH PVT Procrit, Agralon NONE glaucoma, thrombopenia 1
0165277 01/29/2001 NY 77.0 77 F 10/30/2000 The pt complained of a swollen arm, painful with chills the night of the vax. The chills went away when covered up. Put ice on arm. No meds. Y 10/28/2000 10/28/2000 0 NONE UNK PVT Lipitor, Dilacor NONE NONE 1
0165278 01/29/2001 NY 77.0 77 M 11/07/2000 The pt experienced a swollen and red left arm. Put cold water on it and was very sore to the touch. Took ASA. The next day was still red, but not as sore. Y 10/30/2000 10/31/2000 1 NONE OTH UNK hypertension meds NONE allergy to red dye 1
0165279 01/29/2001 NY 76.0 76 F 10/27/2000 The pt experienced a sore injection site, shivering and nausea. The pt couldn't get warm. U 10/26/2000 10/26/2000 0 OTH PVT heart meds, stomach meds NONE NONE 1
0165280 01/29/2001 NY 47.0 47 M 11/03/2000 The pt experienced tenderness to the left armpit, mild aches to the knees, elbows tiredness, eyes burning, general malaise. Pain started disappearing. 2 days later symptoms had resolved. Y 10/29/2000 10/30/2000 1 NONE OTH PVT Norvasc, Diavan NONE NONE pain, swelling~Tetanus Toxoid (no brand name)~~6.00~In Patient 1
0165281 01/29/2001 NY 47.0 47 F The pt complained of redness, tenderness, soreness for 3 days at the injection site. The pt also experienced mild aches, fatigue, no elevated temp. Y 10/29/2000 10/30/2000 1 NONE OTH UNK synthroid NONE NONE 1
0165282 01/29/2001 NY 57.0 57 F 11/03/2000 The pt was diagnosed with shingles. Her hip started to hurt. Yellow Jacket stinging, got rash, then herpes zoster. Treated with anti viral medication. Not vaccine related. Y 10/26/2000 10/30/2000 4 NONE OTH UNK NONE NONE allergy to PCN and allopurinol, diagnosed with leukemia 1
0165283 01/29/2001 OH 1.0 1 .0 F 01/23/2001 The pt developed chicken pox. U 01/12/2001 01/20/2001 8 NONE PVT UNK NONE NONE 1
0165284 01/29/2001 TX 12.0 12 F 01/17/2001 On 1/10/01 the pt went to the ER with a rash and shortness of breath, fever of 100.4 was told to stop Amoxil. On 1/12/01 the rash is still present, pediatrician consulted referred to an allergy specialist. Specialist is unsure is rash is due to PCN reaction, vaccine reaction or viral infection. Y Y 01/10/2001 01/10/2001 0 PUB PUB Amoxil ear infection NONE 1
0165285 01/29/2001 VA 61.0 61 F 01/19/2001 The pt experienced achy joints, flu like symptoms, a choking episode during the day and woke up at night feeling like she couldn't breathe or swallow. The pt went to the ER. An x-ray showed swelling or anomaly in esophagus. No meds given Was referred to a gastroenterologist. Y Y 11/29/2000 12/02/2000 3 OTH PUB slight cough VA01004 1
0165708 01/29/2001 NY 8.0 8 M 01/29/2001 Autopsy pending = Final cause of death. Most likely acute myocarditis. Questionable viral awaiting final culture results. Child has mild temperature 100., and URI. Autopsy states cause of death as myocarditis. Y 01/27/2001 N 01/26/2001 01/26/2001 0 CBC; BMP MG PHOS were to be done that day PVT UNK NONE URI, ? Viral. NONE 1
0165302 01/30/2001 AR 0.3 0 .3 M 01/18/2001 The patient had a seizure 6 hours after the vaccine was given to him. The patient was given the vaccine at 1 PM and had a seizure at 7 PM. Y Y 3 Y Y 06/28/2000 06/28/2000 0 PUB PUB NONE NONE 1
0165303 01/30/2001 TX 1.1 1 .1 F 01/19/2001 On 1/15/01 the pt ran a fever of up to 102 degrees. On 1/16/01 the pt experienced a seizure lasting several minutes. Was taken to the ER and the pt had 3 more seizures at the hospital. Was admitted to ICU on a ventilator. Diagnosed with status asthmaticus w/ respiratory failure and viral infection Y Y Y 3 Y 01/08/2001 01/16/2001 8 WBC - 8.9 (1/16), 5.3 (1/17), CT scan - nml, EEG - nml PUB OTH DTAP - by Aventis, Lot #U0299BA given IM in the L/leg with 3 prior doses NONE NONE 1
0165304 01/30/2001 MD 73.0 73 F 01/06/2001 The pt developed ascending paralysis and Guillain Barre Y U 12/13/2000 12/18/2000 5 EMG, electrophoresis protein - pos for Guillain Barre PUB PUB Norvasc, Arthrotec, Prevacid allergy to PCN and sulfa MD01001 1
0165305 01/30/2001 CA 14.0 14 F 01/22/2001 The pt reports waking up with numbness in both legs on 12/30/00 which had resolved and then reoccurred on 1/9/01. No weakness. Symptoms subsided and then reoccurred again on 1/19/01. FU received states final diagnosis is myelopathy. Y U 12/04/2000 12/30/2000 26 PVT PUB NONE NONE 1
0165306 01/30/2001 CA 22.0 22 M 01/26/2001 Three weeks after this patient had his Influenza shot, sickness of retro-orbital pain, headache, progressive SOB and flaccid paralysis. The patient now on a ventilator, with acute disseminated Encephalomyelitis. Y Y Y 5 N 01/02/2001 01/16/2001 14 CSF culture and viral PCR - neg MIL MIL NONE NONE 1
0165308 01/30/2001 FL 75.0 F 01/25/2001 Sometime following vaccination, the pt developed [[name]] Barre Syndrome. The pt was hospitalized on 1/22/01. Further information is requested. F/U correspondence rec'd on 2/27/01 additional pt and the vaccine administrator info were provided. From faxed f/u correspondence rec'd on 6/18/01 for the doctor,stated that the pt was transferred from one hospital to another hospital on 2/8/01. Teh following info was sent to the doctor on 6/26/01. Date of admission to hospital 2/9/01, date of expiration 3/28/01 at 12:28pm. Dx at time of death Guillian-Barre' syndrome immediate cause of death due to respiratory failure due to problems associated with [[name]] -Barre' syndrome. Follow up 07/26/2001: "final diagnosis was GBS. Diagnosis was not made by a neurologist. it is not known if the patient experienced any other illnesses previous to GBS." Y 03/28/2001 Y N 12/13/2000 PVT PVT Tiazac, Vioxx, Cozaar, Lipitor unspecified shortness of breath allergy to Motrin, HPTN, OA, gastritis, diverticulosis U2001002100 1
0165310 01/30/2001 VA 0.99 0 1 F This patient received Prevnar #3 in right thigh yesterday, the site was red, and swollen, she had 102 fever 10 hours later. This morning the patient had a brief episode of staring, eyelid twitching, lasted 5 minutes. No previous febrile seizures, no family history of febrile seizures; active and alert. Second visit today for seizure less than 5 minutes staring eyelids, twitching, no extremity movement, after returning home temp 102. Brought in via 911 to ER. Then the patient had a fever spike a 8 PM the same day with brief generalized seizure (her 3rd that day) sent to Hospital for 1 day admission. The Dr. evaluated the patient did an LP & blood culture both negative. She was then seen for consultation by pediatric neurology who felt these were simple febrile seizures. The patient well since discharge. Afebrile, no meds. After follow up with peds neurology the visit indicated to the mother that prognosis should be favorable with low risk for permanent seizure disorder. Would not give Prevnar again. Y 1 Y 01/18/2001 01/19/2001 1 Lumbar Puncture and Blood Culture-Neg Chest x-ray - Neg, CBC-Neg PVT PVT Lotrimin Ringworm 1
0165311 01/30/2001 GA 3.0 3 F 01/17/2001 The pt had seizure activity for about a minute, then she was drowsy until she was brought to the ER. Y Y 01/16/2001 01/16/2001 0 PVT PUB Reglan NONE GERD 1
0165312 01/30/2001 CA 0.2 0 .2 F 12/27/2000 The pt was very pale with very little movement 3 hours post vax. This lasted approximately 30 minutes and by the time the pt was seen, the exam was within normal limits. Y Y 12/15/2000 12/15/2000 0 NONE PVT PVT Tylenol NONE NONE 1
0165313 01/30/2001 NM 0.5 6 F 01/19/2001 One hour post vax, the pt experienced redness and itching at the site which continued to increase. The are is approximately 7 inches of redness and itching. No systemic symptoms. Treated with Benadryl and cool compresses. Has a history of milder reaction to MMR and DtaP. Y Y 01/17/2001 01/17/2001 0 NONE UNK UNK 1
0165314 01/30/2001 MT 1.0 1 .0 F 01/07/2001 The pt experienced a severe rash at the first 11 days post vax then was accompanied by a fever. The eyes swelled and started severe itching. MD said could be a mixture of MMR, viral respiratory infection and possible allergy to antibiotic (PCN). The pt was treated with steroids and Benadryl. Y Y 12/21/2000 12/31/2000 10 NONE PVT PVT antibiotics for cold chest cold NONE 1
0165315 01/30/2001 AR 1.5 1 .5 M The pt experienced a large area around the injection site that was still red and swollen. The DTaP was given at that injection site. Y 01/17/2001 01/17/2001 0 NONE PVT PUB NONE NONE 1
0165316 01/30/2001 MD 3.0 3 F 01/24/2001 The pt experienced erythema, induration, swelling, mottling of both the upper extremities, possible cellulitis. Y U 01/22/2001 01/22/2001 0 NONE PUB UNK NONE NONE asthma facial swelling~DTP (no brand name)~1~0.25~In Patient 1
0165317 01/30/2001 CA 1.3 1 .4 U The pt experienced a febrile seizure. Y Y 01/11/2001 01/12/2001 1 CBC, CXR, BC, UA, UL OTH PVT NONE NONE NONE 1
0165318 01/30/2001 PA 1.5 1 .5 M 01/18/2001 The pt experienced a reddened area at the site with some swelling. Was seen in ER and begun on antibiotics. The child was afebrile and appeared well otherwise. Y Y 01/15/2001 01/16/2001 1 NONE PVT PVT NONE NONE NONE 1
0165319 01/30/2001 NY 3.0 1 .3 F 01/18/2001 The pt experienced a fever of 103 within 12 hours and then became afebrile in the next AM. Y 11/14/2000 11/15/2000 1 NONE PVT PVT NONE NONE 1
0165320 01/30/2001 NY 1.0 1 .1 M 01/19/2001 The mom noted a rash on arms, legs, face and trunk (1 day post vax). The pt otherwise seemed fine. The pt was seen and diagnosed with urticaria. U 01/18/2001 01/19/2001 1 PVT PVT resolving Otitis Media NONE 1
0165321 01/30/2001 NY 1.0 1 .0 M 01/18/2001 The pt experienced a fever and lethargy beginning 8 hours following vax. The pt also experienced a runny nose, slight erythema. The throat was normal, chest normal, lungs normal. Y Y 01/17/2001 01/17/2001 0 NONE PUB UNK PPD - left forearm, Tylenol, Motrin NONE NONE 1
0165322 01/30/2001 CA 0.7 0 .7 F 01/19/2001 One day post vax, the pt developed a fine maculo-papular rash over face and thighs, and mild fever. N 01/18/2001 01/18/2001 0 NONE PUB PUB NONE facial birth marks 1
0165323 01/30/2001 MI 1.0 1 .1 F 01/25/2001 The pt experienced erythema, swelling, pain. Treated with Benadryl. Y 12/28/2000 12/28/2000 0 PVT PVT NONE NONE 1
0165324 01/30/2001 NM 0.5 0 .5 M 01/18/2001 Mom states the child was very irritable and experienced inconsolable crying following vaccination. The pt experienced a "subjective" fever at night. Woke up in the AM with a fine papular rash on torso, arms, neck. No rash at the site of injection. The pt was treated with hydrocortisone to apply to affected areas. U 01/17/2001 01/17/2001 0 NONE PVT PUB Tylenol NONE 1
0165325 01/30/2001 WI 1.5 1 .5 M 01/25/2001 The pt had cellulitis at the injection site. She was treated with Augmentin. Y Y 01/18/2001 01/20/2001 2 NONE PVT PVT NONE NONE 1
0165326 01/30/2001 WI 42.0 41 M 01/20/2001 The pt experienced flu-like symptoms with 1st vaccine. After 2nd vaccine the pt experienced memory loss, shortness of breath, headaches, mood swings, confusion, fatigue, dizziness, joint pain, which is ongoing. The pt was treated again with antibiotics (long term). He continues to have problems and is still on antibiotics at this time. The follow up received on 3/7/02 states, "flu like symptosm dr gave 2nd inject. didn't think it was a reaction. My husband now has neurological problems from vaccine. My husbnad was diagnosed with Lyme disease in June of 1999. He had a very bad rash that wrapped around his chest. Engulfing his heart. He also had flu like symptoms. His regular doctor went over the dematologists suggestion of spinal tap and IV antibiotics, and pt received 3 weeks of antibiotics which only helped somewhat. In the fall it was suggested he get the lymerix vaccine against my better judgement, since I only work with animals. We would nevere give a vaccine to a pet with Lyme disease. So agian my husband listened t o his doctor and got the vaccine 3/3/00. By the 10th he was complaining about flu like symptosm again... his doctor brushed it off and gave the second dose of lymerix 4 weeks later. My husband has been struggling with neurological problems ever since. At that point I pushed for the IV antibiotic treatment which helped a bit but by April of 2001 the memory, concentration, achy joints, just feeling sick reoccurred. We are now seeing a doctor out of state since no one seems to know how to treat him up here. I am very upset this vaccine was ever put on the market and I think the ones responsible should pay. We did refuse the booster vaccine in March 2001." N 03/03/2000 03/10/2000 7 PVT OTH Lyme disease 1
0165328 01/30/2001 MN 58.0 58 F 01/25/2001 The pt had a rash, was treated with Benadryl and Medrol dose pack. MD thinks the reaction was due to preservative thimerosal. Y 01/22/2001 01/22/2001 0 PVT PVT NONE 1
0165329 01/30/2001 NH 54.0 54 F 01/19/2001 5 minutes post vax, the pt complained of a temp, rapid heart beat, dizziness, not feeling well. 50-60 minutes post vax, still didn't feel well. Fingers felt clenched and tight. Still had feeling of temp. Y Y 01/12/2001 01/12/2001 0 BIBE PUB PUB Prempro NONE Pt has had similar reaction when given Novocaine for dental purposes. 1
0165330 01/30/2001 OR 57.0 57 F 01/18/2001 The pt experienced a 11 cm x 6cm swollen, red, warm, and itchy area. Treated with Benadryl. 3 days later the reaction is resolving. Y 01/12/2001 01/12/2001 0 PVT PVT Glucophage, NPH, Lipitor, Estrace, Zestoretic, Phentermine, Relafen, Lopid, Nasonex allergic rhinitis IDDM, allergy to quinine, Macrobid, niacin, 1
0165331 01/30/2001 LA 44.0 44 M 01/11/2001 Approximately 6 hour post vax, the pt felt feverish, had a fever of 102, left arm was sore tot he touch. The next evening (1/10/01) the pt noticed a 3 inch whelp on the left arm. Treated with Tylenol. Fever abated after 36 hours. Y 01/09/2001 01/09/2001 0 PUB PUB Asacol fatigue, arthritic feelings hx of ulcerative colitis LA010103 1
0165332 01/30/2001 IN 50.0 50 F 01/22/2001 One day post vax, the pt began to have pain in all joints. The pt continues to have problems with right knee and left ankle. The pt cannot stand or walk for any length of time. There is pain and swelling most of the time in both. N 12/11/2000 OTH PVT Lotrel slight head cold 1
0165333 01/30/2001 PA 47.0 47 F 01/22/2001 45 minutes post vax, the pt experienced itching on arm. 1 hour post vax, the pt experienced whole body itching, red flushing. Treated with Benadryl. 4 hours later was repeated because of symptoms. Y 12/22/2000 12/22/2000 0 PVT UNK Ortho Novum birth control pills NONE NONE 1
0165334 01/30/2001 NV 81.0 81 F 01/23/2001 The pt experienced a headache, fever of 101.9 for 15-20 hours. Fever began 24 hours post vax. The pt took Advil for the fever. The pt also experienced muscular aches. 3 days post vax, the pt experienced diarrhea, queeziness, nasal discharge and a cough for 2 weeks Y 12/29/2000 12/29/2000 0 PUB UNK Premarin, Lipitor NONE NONE 1
0165335 01/30/2001 GA 1.0 0 1 F 01/17/2001 Chickenpox breakthrough after vaccine administered on 2/15/1996. Y 02/15/1996 01/11/2001 1792 PVT OTH NONE Mild ROM 1
0165336 01/30/2001 OR 3.0 3 M 01/19/2001 Left upper arm swollen from shoulder to elbow, red color outer arm to pink noted on inner aspect, hot to touch. No fever. Child alert and happy. Able to move arm well, fingers warm. Recommended cold packs and go to ER/pediatrics if worsens or fever. U 01/17/2001 01/18/2001 1 OTH PUB NONE NONE NONE 1
0165337 01/30/2001 KY 1.8 1 .8 M 01/05/2001 Cellulitis on right thigh, 8cm X 10cm of redness, hot to touch and swelling. Y 01/03/2001 01/05/2001 2 PUB PVT 1
0165338 01/30/2001 NY 0.5 0 .5 M 01/22/2001 Baby awakened 1-3 times each night from 1/5/01 to 1/18/01 with high-pitched screaming, difficult to console. Exam normal on 1/22/01. Y 01/05/2001 01/05/2001 0 NONE PVT PUB NONE NONE NONE 1
0165339 01/30/2001 CO 23.0 23 F 01/19/2001 Client received Hep-B #1 (Recombivax) LDT and PPD-TB (Tubersol) in RFA and 10 minutes later, developed rash on neck and a scratchy throat. Went to ER experiencing breathing difficulties. Received Epinephrine and injection of Benadryl and recovered within minutes. Y Y 01/16/2001 01/16/2001 0 OTH PVT PPD-Tubersol (Pasteur)/C0141AA/ID/RFA/0 previously NONE NONE 1
0165340 01/30/2001 IN 41.0 41 M 01/22/2001 6cm X 6cm erythema, tenderness and swelling at injection site. Y 01/20/2001 01/21/2001 1 PVT UNK NONE Laceration NONE 1
0165341 01/30/2001 CA 42.0 42 F 01/19/2001 Developed swelling and redness on left upper arm on 1/14/01 (2 days, post vax). Seen at ER on 1/14/01 and Rx'd with Keflex and Benadryl. Seen by PMD on 1/15/01 and antibiotic changed to Cipro. Y Y 01/12/2001 01/14/2001 2 OTH OTH lisinopril NONE Allergic to PCN 1
0165342 01/30/2001 NC 24.0 24 F 01/20/2001 Shortness of breath, disorientation, sweats, tingling sensation in hands and feet, chills, weakness, red blotches on face, neck and feet, dizziness and nausea. Treated with Prednisone. (4 weeks recovery, 1st time). Y U 01/03/2001 01/16/2001 13 Ultrasound of liver-elevated liver enzymes OTH PUB 2nd vaccine was given without knowledge of this being the reaction of the 1st vaccine. 1
0165343 01/30/2001 MA 63.0 63 F The symptoms started the following day. Itching, redness, swelling and heat. The swelling kept spreading. Called doctor's office and doctor recommended Benadryl and compresses. Three days later, went to ER and was told that I had a severe allergic reaction. Prescribed Prednisone. Swelling had moved to lower arm. Y Y 01/10/2001 01/11/2001 1 PVT UNK NONE Diabetes, Hypothyroidism, High Blood Pressure. 1
0165344 01/30/2001 DE 12.0 12 F 01/22/2001 Rash on face, neck and legs, less than 24 hours, post vax. Took Benadryl (po). Y 01/16/2001 01/16/2001 0 PVT PVT 1
0165345 01/30/2001 SD 51.0 51 F 01/18/2001 Severe swelling of affected arm, joint and muscle pain and swelling. Given NSAID therapy with good relief. Questionable serum sickness versus allergy to serum. Phone consult. Y 01/04/2001 01/05/2001 1 NONE PVT PVT Multivitamins, vitamin E, Prempro NONE Allergy to doxycycline, eggs, horse dander; (+) PPD; Aortic stenosis 1
0165346 01/30/2001 MI 4.0 4 M 01/16/2001 Awoke today fine, took multivitamins, then noted marked edema of left cheek and pain with mild erythema. On exam, left parotid gland is enlarged and mildly tender. Y U 01/15/2001 01/16/2001 1 PVT PVT Tylenol NONE Febrile seizure at 17 months old 1
0165347 01/30/2001 FL 20.0 20 M 01/18/2001 No data provided. Y Y 01/18/2001 01/18/2001 0 PUB UNK NONE 1
0165348 01/30/2001 UT 26.0 26 F 01/18/2001 Cellulitis, 24 hours, post vax. Pt went to local ER and was treated with Ancef, Rocephin and Augmentin. Temperature 102F. Cellulitis has responded to treatment. Y Y 01/11/2001 01/12/2001 1 PUB PUB trimethoprim, sulfamethoxazole NONE 1
0165349 01/30/2001 UT 3.0 3 M 01/16/2001 Child awoke the day following his vaccinations, with swollen, purple lips, swollen gums, pale face and a purple rash under the pale skin. Mom reports he felt fine, no fever, no trouble breathing. Rash didn't itch. Symptoms cleared up in 3 days. Y 01/12/2001 01/13/2001 1 NONE PUB PUB NONE NONE UNK 1
0165350 01/30/2001 FL 4.0 4 F 01/19/2001 High fever at night (parents did not measure), cough at night, vomiting and stomach ache on 1/16/01 and 1/17/01. Epistaxis X3 on 1/18/01. No local reaction. Temperature 101.4F on 1/19/01 at 10:30. U 01/16/2001 01/16/2001 0 PUB UNK NONE NONE 1
0165351 01/30/2001 NJ 1.0 M 12/10/2000 Fever after 1 day and a rash after 4 days, post vax. Y Y PVT UNK Cold 1
0165352 01/30/2001 TN 24.0 24 F 12/01/2000 Td booster given per protocol. Pt called on 11/29/00 with complaint of pain and swelling at injection site. Instructed to take Benadryl and ibuprofen per directions on bottle, apply ice pack to site. Called on 12/1/00. Had client come in to clinic. Irregular, red, raised patches on right deltoid, warm to touch. Arm on right 1" larger than left. States better "but still painful, itches and is swollen". U 11/28/2000 11/29/2000 1 PUB OTH Benadryl, Ibuprofen NONE Allergy to PCN, ASA and Codeine. 1
0165353 01/30/2001 VA 1.5 1 .7 M 01/25/2001 Extreme erythematous upper left arm, inferior to DTAP injection. U 01/23/2001 01/23/2001 0 PVT PVT NONE 1
0165354 01/30/2001 AR 12.0 12 F 01/03/2001 Father reports that child broke out in hives, post vax, 1st Hep-B on 9/28/00. Mom is a nurse and treated child with Benadryl and the only thing that was different with child on that day, father reported, was Hep-B vaccine. Father reported this on 2nd visit for Hep-B. Y 09/28/2000 09/28/2000 0 PUB PUB AR0600 1
0165355 01/30/2001 CA 0.4 0 .4 M 10/25/2000 On 10/11/00 PM, child was fussy, decreased appetite, lethargy and temperature of 99F (rectal). Father called 7 days later, regarding sluggishness and cramps. Seen in ER; weight loss of 4 oz., temperature 98F. PE by MD-WNL. Possible gastritis. Y Y 10/11/2000 10/11/2000 0 PUB PUB NONE NONE CA000162 1
0165356 01/30/2001 WA 0.2 0 .2 F 01/12/2001 Evening following DTAP, pt became decreasingly alert, decreased appetite and difficult to awaken. Pt was then evaluated in our office, the following day. Mom reported symptoms confirmed and baby was tachycardic. Pt admitted to hospital for observation. Y Y Y 01/08/2001 01/08/2001 0 PVT UNK Cough 1
0165357 01/30/2001 MS 1.0 0 1 M 01/24/2001 Developed blanching, erythematous rash on cheeks, neck and upper chest, 15 minutes, post vax. Almost resolved by 45 minutes after vaccine. Y 01/23/2001 01/23/2001 0 NONE PUB PUB NONE NONE 1
0165358 01/30/2001 CA 0.2 0 .3 F 01/22/2001 Baby received 1st immunization. Mother advised of possible reactions. Baby cried continuously for 5 hours, following IZ. Mom called and was advised to see PMD, immediately. Did not have transportation. Public Health Nurse and Immunization Coordinator went to home. Baby examined and appeared active, alert and in no distress. Temperature normal. Breast feeding. Y 01/19/2001 01/19/2001 0 PUB PUB NONE NONE CA010002 1
0165359 01/30/2001 MD 45.0 44 M 01/23/2001 Complaining of angioedema and pruritic, urticarial rash off and on, post vax of Hep-A vaccine (which was done for travel reason). N 03/19/2000 All neg. for underlying diseases. PVT PVT NONE NONE NONE 1
0165360 01/30/2001 MS 0.6 0 .6 F 01/24/2001 About 18:00 on 1/22/01, she had 1 diaper of severe diarrhea and no more. About 7 or 8 PM, she began vomiting and vomited everything. Mom was finally able to give her a bottle about 23:59. Baby had fever and vomited again at 02:00 on 1/23/01 (temperature was 100.3F). Had Tylenol hours before she vomited and more after. Then baby went limp and turned white as a ghost. Could not wake her up. Went to ER. Stayed with way 2-3 hours. Began responding better at hospital. Color back the next day. Temperature 100.3F (A) at 10:00 and 20:30 was 100.8F. Refused to eat but did take about 8 oz fluid on 1/23/01. Had only 2 wet diapers from 05:00 to 23:00 on 1/23/01. Went to PMD on 1/24/01 with dx of tonsillitis. Y Y 01/22/2001 01/22/2001 0 PUB PUB Nystatin oral suspension for thrush for 2 weeks Thrush Acid reflux MS01002 1
0165361 01/30/2001 MS 5.0 5 M 01/24/2001 Mother called clinic on 1/24/01 complaining of child having a fever of 102F to 103F and a headache since his fever not relieved by Motrin. Doctor in clinic today, instructed to take child to PMD now for evaluation with copy of shot record including vaccines given on 1/23/01. U 01/23/2001 01/23/2001 0 PUB PUB NONE NONE NONE MS01003 1
0165389 01/30/2001 NC 73.0 M 12/27/2000 A male, now 75 years old, reported that he received an influenza virus vaccine a "couple of years ago" and reportedly could not use his arms shortly afterwards. He could no lift them above his head and he reported that "a virus entered my body when I received the flu shot". U UNK OTH OTH UNK UNK UNK HQ2954230OCT2000 1
0165390 01/30/2001 DE 53.0 F 12/22/2000 A female adult reported that she received '98-'99 formula influenza virus and Pneumovax 23 vaccines in 1998 and subsequently, developed a rash on her lower extremities. She was treated with diphenhydramine. She recovered. Y UNK OTH OTH UNK UNK UNK HQ2588221OCT2000 1
0165392 01/30/2001 NY 47.0 F 12/27/2000 A 47 year old female consumer reported that she received an influenza vaccine on 9/26/00. On 10/4/00, she experienced sneezing and nasal congestion. U 09/26/2000 10/04/2000 8 UNK OTH OTH Prempro, Humulin Insulin UNK Diabetes Mellitus NOS; Hormone replacement therapy HQ2076111OCT2000 1
0165393 01/30/2001 MO U 12/15/2000 A nurse reported approx. 12 pts from a single institution who received injections of Flu-Shield ('00-'01) on 11/6/00 and 11/07/00 developed injection site reactions characterized by redness, swelling and "spots" within a 2" diameter of injection. The reactions abated after 24 hours. The reporter indicated that approx. 12 pts experienced these events; however, they are not presently identifiable. Additional reports will be generated when identifying information is provided. Follow up information received 01/25/2001 from the original reported revealed all the patients recovered within 48 hours of the events. No patient specific information was provided. Y 11/06/2000 11/06/2000 0 UNK OTH OTH UNK UNK UNK HQ3438209NOV2000 1
0165394 01/30/2001 NC U 12/21/2000 A nurse reported that a pt received an injection of Flu Shield '00-'01 on 11/14/00 and subsequently developed an injection site reaction characterized by burning, "severe" pain, swelling, and redness. No further information was available at the date of this report. The reporter indicated that a total of 5 pts from this facility experienced this event; however, they are not presently identifiable. Additional reports will be generated when identifying information is provided. U 11/14/2000 UNK OTH OTH UNK UNK UNK HQ3851017NOV2000 1
0165395 01/30/2001 MD F 12/21/2000 A nurse reported a female pt received an injection of influenza virus vaccine on an unspecified date. Subsequent to vaccination, the pt developed a terrible cold with a tight, sore throat and an injection site reaction characterized by redness and pain. U UNK OTH OTH UNK UNK UNK HQ4080227NOV2000 1
0165396 01/30/2001 TX 39.0 39 F 12/21/2000 An MA reported that a 39 year old female received an injection of Flu Shield '00-'01 on 11/17/00 and subsequently, developed pain down her right side that extends to her toes. She is also having trouble walking. U 11/17/2000 11/17/2000 0 UNK OTH OTH UNK UNK UNK HQ4082427NOV2000 1
0165397 01/30/2001 VA M 12/21/2000 On 11/22/00 the results of the tuberculin test were reportedly positive following the receipt of flu shield. U 11/17/2000 11/22/2000 5 UNK PVT PVT tuberculin - PPD NONE UNK HQ4096227NOV2000 1
0165398 01/30/2001 NC 42.0 42 M 12/21/2000 A nurse reported that a 42 year old male received an injection of Flu Shield '00-'01 on 11/18/00 and subsequently, developed a fever, hoarseness and a sore throat. On 11/22/00, she was seen by the physician. Follow up information received from the physician on 01/05/2001 indicated the patient recovered. Y Y 11/18/2000 UNK PVT PVT Lipitor, Prevacid, vitamin E NONE Oesophageal reflux with history of induced laryngitis HQ4100327NOV2000 1
0165399 01/30/2001 CT 53.0 53 F 12/27/2000 A 53 year old female reported that she received an injection of Flu Shield '00-'01 on 10/26/00. Ten days, post vax, she developed an injection site reaction characterized by an indentation, pain, and tingling that radiated down her arm. She also developed neck pain. She was treated with gabapentin and celecoxib. As of 11/27/00, the symptoms persisted. Follow up information was received from an infectious disease specialist on 03/28/2001 who indicated that the patient was diagnosed with fat necrosis at the injection site. U 10/26/2000 11/05/2000 10 UNK PVT OTH Actonel, Premarin NONE UNK HQ4177028NOV2000 1
0165400 01/30/2001 NJ M 12/22/2000 A pharmacist reported that a male received an injection of Flu Shield '00-'01 in 11/00 and subsequently, has experienced irritation of his eyes when using contact lens solution containing thimerosal. The reporter indicated that the pt had no previous history of sensitivity to thimerosal. No further information was available at the date of this report. U 11/01/2000 UNK OTH OTH UNK UNK UNK HQ4338301DEC2000 1
0165401 01/30/2001 FL 67.0 67 F 12/22/2000 A 67 year old female reported that she received an injection of Flu Shield '00-'01 on 11/30/00 and subsequently experienced an increase in pain. U 11/30/2000 11/30/2000 0 UNK PVT PVT UNK NONE Atrioventricular block NOS; back pain; carpal tunnel syndrome; injury NOS; limb injury NOS; Spinal disorder NOS; valvular heart disease NOS; diabetes mellitus with peripheral neuropathy NEC HQ4516406DEC2000 1
0165402 01/30/2001 NY 54.0 M 12/21/2000 A 54 year old male reported that he received an injection of Flu Shield '00-'01 on 11/30/00. On 12/1/00, he developed redness and itching over his entire body. He also developed "dime-sized" hives at he injection site. He was treated with methylprednisolone. The hives resolved. As of 12/4/00, the redness and itching persisted. Follow up information received from the physician on 01/05/2001 indicated that the patient recovered. Y 12/01/2000 UNK OTH PUB Ocupress NONE UNK HQ4522206DEC2000 1
0165403 01/30/2001 NC 22.0 22 F 12/21/2000 A nurse reported that a 22 year old pregnant female inadvertently received an intradermal injection of Flu Shield '00-'01 instead of a tuberculin test on 11/30/00. That day, she developed an injection site reaction characterized by redness and a bruise. Follow up from the physician received 02/06/2001 indicated that the injection site reaction resolved. Y 11/30/2000 11/30/2000 0 UNK PVT PUB NONE NONE Pregnancy NOS (Serum) HQ4540306DEC2000 1
0165404 01/30/2001 KY 49.0 49 M 12/27/2000 A healthcare professional reported that a 49 year old male received an injection of Flu Shield '00-'01 on 11/27/00 and subsequently experienced tingling in his legs and nausea. This is 1 of 2 pts from this facility who experienced this event, post vax, lot #4008185. U 11/27/2000 UNK PVT PVT UNK NONE UNK HQ4632308DEC2000 1
0165405 01/30/2001 NC U 12/21/2000 A nurse reported that a pt received an injection of Flu Shield '00-'01 on 11/15/00 and subsequently developed an injection site reaction characterized by burning, "severe" pain, swelling and redness. This is 1 of 5 pts from this office who experienced an adverse event with Flu Shield. No further information was available at the date of this report. U 11/15/2000 UNK OTH OTH UNK UNK UNK HQ4690411DEC2000 1
0165406 01/30/2001 NC U 12/22/2000 A nurse reported that a pt received an injection of Flu Shield '00-'01 on 11/16/00 and subsequently developed an injection site reaction characterized by burning, "severe" pain, redness and swelling. This is 1 of 5 pts from this office who experienced an adverse event with the administrating of Flu Shield. No further information was available at the date of this report. U 11/16/2000 11/16/2000 0 UNK OTH OTH UNK UNK UNK HQ4690511DEC2000 1
0165407 01/30/2001 CA 61.0 61 F 12/21/2000 A healthcare professional reported that a 61 year old female received an injection of Flu Shield '00-'01 on 12/06/00. Within 24 hours, the pt developed a rash with hives on her forearms, neck, and trunk, pruritus and wheezing. The pt was treated with epinephrine and Benadryl but the rash worsened. The reporter noted that Flovent therapy "may also be the cause" of the events. U 12/06/2000 12/07/2000 1 UNK PVT OTH Diovan, Flovent UNK Asthma NOS HQ4706111DEC2000 1
0165408 01/30/2001 NC 32.0 32 F 12/22/2000 A nurse reported that a 32 year old female received Flu Shield '00-'01 on 12/4/00. On 12/5/00, she developed a red and swollen arm and was seen by her rheumatologist. A dx of infection at the injection site was made. The pt was prescribed an antibiotic. U 12/04/2000 12/05/2000 1 UNK PVT PVT Celebrex, Oxycontin, Norontin NONE UNK HQ4706511DEC2000 1
0165409 01/30/2001 NC U 12/29/2000 A nurse reported that a pt received an injection of Flu Shield '00-'01 on 12/4/00 and the next day, the pt developed an injection site reaction characterized by redness, soreness, swelling and itching. The reaction was managed with an unspecified antibiotic. U 12/04/2000 12/05/2000 1 UNK OTH OTH Celebrex, Neurontin, Oxycontin UNK UNK HQ4760112DEC2000 1
0165410 01/30/2001 NY U 12/27/2000 A physician reported that a pt received an injection of Flu Shield '00-'01 and subsequently developed hypoglycemia. The reporter indicated that he did not believe that the pt's experience of hypoglycemia was caused by Flu Shield. Follow up states patient recovered. Y UNK OTH OTH UNK UNK UNK HQ4802313DEC2000 1
0165411 01/30/2001 CA 78.0 78 F 12/22/2000 A 78 year old female reported she received an injection of '00-'01 of influenza virus vaccine on 11/7/00. Subsequently, she experienced dizziness, headache, insomnia and bone aches. The caller stated that her physician found no evidence of infection. U 11/07/2000 UNK OTH OTH Prednisone UNK UNK HQ4874414DEC2000 1
0165412 01/30/2001 CO U 12/22/2000 A nurse practitioner reported that a pt received an injection of Flu Shield '00-'01. Following the immunization, the pt's INR (international normalized ratio) was increased. No further information was available at the date of this report. The reporter indicated that 2 or 3 pts experienced this event; however, they are not presently identifiable. Additional reports will be generated when identifying information is provided. U INR-increased OTH OTH UNK UNK UNK HQ4890414DEC2000 1
0165413 01/30/2001 IN 20.0 20 F 12/27/2000 A nurse reported that a 20 year old female with a history of asthma received an injection of Flu Shield '00-'01 on 12/12/00. On the morning of 12/13/00, she experienced numbness and tingling in her left arm and left leg. The reporter indicated the physician treated the reaction as an allergic reaction. She recovered. Y 12/12/2000 12/13/2000 1 UNK OTH PUB Proventil NONE Asthma NOS HQ4900115DEC2000 1
0165414 01/30/2001 VA M 12/22/2000 A nurse reported that a male received injections of Flu Shield '00-'01 and tuberculin, PPD on 11/20/00. On 11/22/00, the results of the pt's tuberculin test were reportedly positive. This is 1 of 2 pts from this facility who developed a positive tuberculin test following receipt of Flu Shield lot 4008183. U 11/20/2000 Tuberculin-positive PVT PVT Tuberculin, PPD-positive NONE UNK HQ5124420DEC2000 1
0165415 01/30/2001 VA F 12/27/2000 A nurse reported that a female received an injection of Flu Shield '00-'01 and within 24 hour, she developed mastitis in her right breast. She was treated with antibiotics. She recovered. No further information was available at the date of this report. Y UNK PUB OTH UNK UNK UNK HQ5158221DEC2000 1
0165416 01/30/2001 NV 34.0 34 F 12/27/2000 A nurse reported that a 34 year old female received an injection of Flu Shield '00-'01 on 11/23/00 and subsequently, developed neck and shoulder pain. She recovered after 2 weeks. This is 1 of 2 pts from this facility who had an adverse experience, post vax, Flu Shield. Y 11/23/2000 UNK OTH OTH UNK UNK UNK HQ5178221DEC2000 1
0165417 01/30/2001 KY 52.0 52 F 12/27/2000 A healthcare professional reported that a 52 year old female received an injection of Flu Shield '00-'01 on 11/29/00 and subsequently, experienced tingling in her legs and nausea. This is 1 of 2 pts from this facility who experienced this event following receipt of Flu Shield lot 4008185. U 11/29/2000 UNK PVT PVT UNK NONE UNK HQ5229422DEC2000 1
0165418 01/30/2001 NV F 12/27/2000 A nurse reported that a female pt received Flu Shield '00-'01 and Pneumovax 23 (MSD) vaccines on 11/13/00 and subsequently, developed neck and shoulder pain. She recovered after 2 weeks. This is 1 of 2 pts from this facility who had an adverse experience following receipt of Flu Shield. Y 11/13/2000 UNK PVT OTH UNK UNK UNK HQ5244727DEC2000 1
0165419 01/30/2001 IN 45.0 M 04/04/2001 The wife of a 45 year old male reported that her husband received an injection of influenza virus vaccine. The next day, he experienced numbness and tingling of his feet extending into the pelvic area. The pt was seen by a physician who sent him to an ER. The pt was also seen by a neurologist. Y U Unspecified blood tests, an MRI, X-rays and nerve conduction tests were performed; however, result were not provided. OTH OTH UNK UNK UNK HQ5408129DEC2000 1
0165420 01/30/2001 PA 33.0 33 F 01/17/2001 A nurse reported that a 33 year old female received an injection of Flu Shield '00-'01 on 11/15/00. Immediately, post vax, she developed a painful knot in her neck. She was treated with ibuprofen and it resolved after 3 hours. Later that day, she developed a swollen tongue and numb lips that "felt like pins and needles". She felt strange and became pale. She was treated with oral diphenhydramine. She recovered on 11/16/00. This is 1 of 3 pts from this facility who had an adverse experience following receipt of Flu Shield '00-'01, lot 4008176. Y 11/15/2000 11/15/2000 0 UNK PVT PVT NONE NONE UNK HQ5928515JAN2001 1
0165421 01/30/2001 VA 47.0 47 F 12/27/2000 A 47 year old female received an injection of Flu Shield '00-'01 on 10/30/00. On 10/31/00, she reportedly developed swelling at the injection site. U 10/30/2000 10/31/2000 1 UNK PVT OTH Atenolol, lorazepam, ranitidine, Zoloft NONE UNK HQ3202503NOV2000 1
0165422 01/30/2001 CA F 12/21/2000 A female reported that she received an injection of Flu Shield '00-'01 on 10/25/00 and subsequently developed redness at the injection site. As of 11/9/00, the redness persisted. No further information was available at the date of this report. U 10/25/2000 UNK OTH OTH UNK UNK UNK HQ3506710NOV2000 1
0165423 01/30/2001 PA 42.0 42 F 12/21/2000 A nurse reported that a pt received an injection of Flu Shield '00-'01 on 11/15/00 and subsequently developed an injection site reaction. No further information was available at the date of this report. The reporter indicated that 3 pts experienced this event; however, they are not presently identifiable. Additional reports will be generated when identifying information is provided. Follow up states additional information received on 01/10/2001 indicated that the patient is a 42-year-old female who developed redness, swelling, and warmth at the injection site. The patient recovered after 3 to 4 days. Y 11/15/2000 UNK PVT PVT UNK UNK UNK HQ3872617NOV2000 1
0165424 01/30/2001 WA U 12/22/2000 A nurse reported that a pt received an injection of Flu Shield '00-'01 on 11/15/00 and subsequently developed an injection site reaction. No further information was available at the date of this report. The reporter indicated that 5 pts experienced this event; however, they are not presently identifiable. Additional reports will be generated when identifying information is provided. U 11/15/2000 UNK UNK UNK HQ3874717NOV2000 1
0165425 01/30/2001 IN U 12/21/2000 A nurse reported that a pt received an injection of Flu Shield on 11/16/2000 and subsequently developed an injection site reaction characterized by a reddened area. U 11/16/2000 UNK PVT PVT UNK UNK UNK HQ4089327NOV2000 1
0165426 01/30/2001 IA 33.0 33 M 12/21/2000 A pharmacist reported that a 33 year old male pt received Flu Shield '00-'01 and Pneumovax on 11/28/00. On that same date, the pt developed an injection site reaction characterized by a hard knot. The event has since resolved. Y 11/28/2000 11/28/2000 0 UNK PVT OTH CellCept, Neoral, Norvasc, Pepcid, Prednisone, Toprol XL UNK Renal transplant HQ4284430NOV2000 1
0165427 01/30/2001 OH 39.0 F 12/21/2000 A nurse reported that a 39 year old female received an injection of Flu Shield '00-'01 on 11/16/00. On 11/28/00, she developed soreness at the injection site and pain in her arm with movement. Follow up information received on 01/03/2001 indicated the patient recovered. Y 11/28/2000 UNK PUB OTH UNK UNK UNK HQ4332201DEC2000 1
0165428 01/30/2001 NC U 12/21/2000 A pharmacist reported that a pt received an injection of Flu Shield '00-'01 on 12/2/00 and 2 days later, the pt developed an injection site reaction characterized by a "knot at the injection site". U 12/02/2000 12/04/2000 2 UNK OTH OTH UNK UNK UNK HQ4518606DEC2000 1
0165429 01/30/2001 IN U 12/21/2000 A nurse reported a pt received an injection of Flu Shield '00-'01 on 11/16/00 and subsequently developed an injection site reaction characterized by a "hard knot". U 11/16/2000 UNK PVT PVT UNK UNK UNK HQ4966218DEC2000 1
0165430 01/30/2001 IN F 12/21/2000 A nurse reported a female pt received an injection of Flu Shield '00-'01 on 11/16/00 and subsequently developed an injection site reaction characterized by swelling. The pt also developed a pin-point rash on her chest. The pt "felt the reaction was due to the bandaid as she said it went away when she took the bandaid off". Y 11/16/2000 UNK PVT PVT UNK UNK UNK HQ4966318DEC2000 1
0165431 01/30/2001 IL 11.0 11 M 12/21/2000 A nurse reported that an 11 year old male received an injection of Flu Shield '00-'01 on 12/15/00. That same day, the pt developed an injection site reaction characterized by pain and hives. Within 48 hours, the hives spread over his entire body. The child was treated with Benadryl and prednisone and the child "seemed to be getting better." Follow up states hives resolved in one week. No residual problems at this time. U 12/15/2000 12/15/2000 0 UNK PVT OTH Adderall, albuterol UNK Asthma NOS; Drug hypersensitivity (environmental and codeine allergy) HQ5096120DEC2000 1
0165432 01/30/2001 M 12/28/2000 A consumer reported that he received an injection of Flu Shield '00-'01 on 12/14/00 and subsequently developed pain in the shoulder area of his left arm and can not raise his arm. U 12/14/2000 UNK OTH OTH UNK UNK UNK HQ5274927DEC2000 1
0165433 01/30/2001 PA 56.0 56 F A nurse reported that a 56 year old female received an injection of Flu Shield '00-'01 on 11/15/00 and subsequently developed an injection site reaction characterized by redness, swelling and warmth. She recovered after 2 weeks. This is 1 of 3 pts from this facility who had an adverse experience following receipt of Flu Shield '00-'01, lot 4008176. Y 11/15/2000 UNK PVT PVT Propylthiouracil NONE Drug hypersensitivity HQ5928415JAN2001 1
0165434 01/31/2001 CO 59.0 59 F 12/20/2000 The same day of the vax, the pt developed hives. She was treated with antihistamines. The next day she experienced difficulty swallowing and a drop in her diastolic BP to 60. The pt was admitted to the hospital and treated with prednisone and epinephrine. As of 11/27/00 the pt had been discharged from the hospital. Follow-up information received 12/18/00 indicated that the pt was seen in the ER and then hospitalized for 5 days. Follow-up information also included the state and county of the vaccine administration and the correct phone number of the reporter. Y Y 5 U 11/18/2000 11/19/2000 1 UNK PVT OTH Zantac, Acyclovir, Premarin UNK UNK HQ4156228NOV2000 1
0165436 01/31/2001 CA 28.0 28 F 01/26/2001 The pt received both vaccines in Mexico. On 11/14/00, the pt had positive pregnancy test with a LMP of 9/29/00 and an estimated due date of 7/6/02. On 12/28/00 an ultrasound revealed a 7.5 week sac without a fetal pole and yolk sac. On 12/27/00 an ultrasound revealed no fetal pole identified. On 12/28/00 the pt had a spontaneous abortion at 13 weeks. On 12/30/00 a pathology revealed no fetal tissue, only placental tissue that is consistent with either a blighted ovum or an abnormally developing pregnancy. Additional information has been requested. Y N 10/02/2000 12/28/2000 87 ultrasound - no fetal tissue, ultrasound - 7.5 week sac without fetal poles or yolk sac, serum beta human OTH OTH Macrobid Concurrent conditions: Pregnancy (LMP= 09/29/00), Urinary tract infection WAES00120052 1
0165438 01/31/2001 IL 0.6 0 .6 F 01/17/2001 The pt became ill and was seen by the MD on 1/3. The pt experienced otitis media, URI, lethargic behavior, had projectile vomiting the night before. The child was hospitalized with possible meningitis, brain tumor or aneurysm. Has since returned home and is on Dilantin. Diagnosis is L frontal cerebral hemorrhage and R superficial femoral artery occlusion. Document no 213382 states that client is still being seen in P. Last MRI, 02/2002. Mother stated next MRI to be done 05/2002, child has recently had chicken pox. He is active, motor skills good. Mother states being told non malignant tumor - decreasing in size not attached to brain, don't feel it is a blood clot and wish to continue to monitor. No medication since 09/2001. The folllow up received on 3/20/01 states on "1/3/01 est 12pm physician visit-s/s unknown at time except projectile vomiting on 1-2. On 1/5/01 pm-child had seizure. Health dept is following up to get more info. I believe you can use 1/3/01 as the onset date." Y Y 12/26/2000 01/03/2001 8 PUB PUB NONE NONE NONE IL01002 1
0165439 01/31/2001 NY 54.0 54 F The pt experienced stiffening of feet joints, leg joints, severe pain in fingers, brought on by rheumatoid arthritis. The pt is being treated with Celebrex and going to a rheumatologist. 60 day follow-up states the pt had headaches as well as the stiffness in legs and angles. Missing vaccine information not available. Y Y N 07/31/2000 09/25/2000 56 x-ray, blood work and exams PVT PVT NONE NONE NONE 1
0165440 01/31/2001 IA 0.5 0 .5 F 01/22/2001 The pt experienced a fever, emesis, irritability and leukocytosis. Diagnosed with possible reaction to vaccine Y 2 Y 01/16/2001 01/16/2001 0 WBC - 31,000, CRP - 1.0, spinal fluid - nml, blood, urine and CSF cultures - neg PVT UNK eye mattering / conjunctivitis allergy to erythromycin and sulfa 1
0165441 01/31/2001 MA 1.0 1 .3 F 01/09/2001 24 hours following vaccination the pt spiked a fever up to 106, was not responsive to acetaminophen, ibuprofen, baths. The pt then had a febrile seizure. Y Y 12/28/2000 12/30/2000 2 blood and urine cultures - neg PVT PUB NONE NONE febrile seizures 1
0165442 01/31/2001 0.2 0 .2 F 01/17/2001 On 6/9/00 the pt developed crying and multiple 1-3 second episodes of stiffening, breath holding and color changing where she turned red and purple and was hospitalized. It was reported that she experienced these episodes more than 12 -15 times during the first 2-3 hours, however she did not experience any episodes while she was sleeping. The episodes gradually decreased overnight. Additionally it was indicated that the pt was monitored and that she did not become bradycardic nor did she desaturate. She was treated with acetaminophen and observed for less than 24 hours recovered and then was discharged. As of 9/5/00, the pt remains recovered. Y Y 1 Y 06/09/2000 06/09/2000 0 OTH OTH UNK WAES01010897 1
0165443 01/31/2001 0.2 M 02/25/2002 Information has been received from a pharmacist concerning a 2 month old male who was vaccinated with Haemophilus B conjugate vaccine (+) Hepatitis B vaccine recombinant (yeast). Concomitant vaccination included Poliovirus vaccine (IPOL) and Diphtheria toxoid (+) Pertussis vaccine (+) Tetanus toxoid (Acel-Immune). Subsequently ten days post-immunization, the patient developed a cough, fever and irritability. The infant was seen by a physician and a Chest x-ray was performed. The x-ray showed an enlarged heart, which had been normal size at birth. A diagnosis of Cardiomyopathy was made and the infant was hospitalized at a Tertiary Care Center to under go heart transplantation. No further information is available. Other business partner's numbers included F200100095 (0) and U200100030(0). Y U x-ray- enlarged heart dx as cardiomyopathy OTH OTH UNK WAES01010895 1
0165449 01/31/2001 MN 1.0 1 .0 M 01/26/2001 On 11/18/00, the pt developed a fever of 105 and rapid breathing. The pt was dx with pneumonia and possible bacteremia. Hospitalization was presumed but not documented. Y Y Y U 11/07/2000 11/28/2000 21 blood culture and chest x-ray-nml PVT OTH UNK WAES01010969 1
0165450 01/31/2001 F 01/26/2001 Information has been provided from an anonymous female consumer who in approximately July 1998, approximately two and a half years ago, was vaccinated with her third dose of Pneumococcal vaccine 23 Polyvalent. The patient stated that the vaccination is now "attacking" and "degenerating" all of the elastic fibers in her body. The caller stated that she already reported this to someone else, But would not say to whom. The patient sought unspecified medical attention. Upon internal review the patient's experience was determined to be an other important medical event. Y U 07/01/1998 OTH OTH UNK UNK WAES01011422 1
0165452 01/31/2001 NJ 1.25 1 .3 M 01/20/2001 Post vax, the pt developed loss of eye contact, no socialization, no language, not responding to his name, and withdrawn. Dx with autism. Y N 09/09/1998 09/16/1998 7 PVT PVT NONE NONE brother has autism ~Hep B (no brand name)~1~0.08~In Sibling 1
0165453 01/31/2001 NJ 0 .0 M 01/20/2001 Post vax, the pt began to push away when held, refused comforting, no eye contact, screamed when touched/handled, and had no recognition of own parents. Dx with autism. Y N 02/28/1995 02/28/1995 0 PVT PVT NONE NONE NONE ~Measles + Mumps + Rubella (MMR II)~1~1.30~In Sibling 1
0165454 01/31/2001 NJ 0.6 0 .5 M 01/20/2001 Post vax, the pt stopped responding to his name, stopped "seeing" people including his mother, lost all language, stopped pointing and waving bye bye, and stopped following 1 step commands. Dx with autism. Y N 10/05/1999 12/04/1999 60 UNK UNK NONE 2 brothers with autism ~Measles + Mumps + Rubella (MMR II)~1~1.30~In Sibling|~Hep B (no brand name)~1~0.08~In Sibling 1
0165455 01/31/2001 WA 2.0 2 .1 F 01/24/2001 The pt experienced idiopathic thrombocytic purpura. Symptoms included bruise, petechiae, nose and mouth bleed. Platelets less than 5000. Treated with IV globulin 2 times. Y Y 2 Y 01/09/2001 01/21/2001 12 WBC, HCT, platelets <5,000 PVT PUB cleft palate 1
0165456 01/31/2001 IN 0.5 0 .5 F 01/22/2001 The pt experienced a 5 x 4 cm induration at the site of injection with erythema and warmth. Y U 01/20/2001 01/21/2001 1 NONE PVT PVT NONE NONE NONE 1
0165457 01/31/2001 CA 1.0 1 .0 M 01/22/2001 The pt experienced a rash all over his body and swollen skin. Y Y 01/19/2001 01/20/2001 1 NONE PUB OTH DTAP also given on 1/19/01 NONE allergy to PCN 1
0165458 01/31/2001 CO 1.3 1 .3 M 01/19/2001 The pt experienced a rash on the torso. Cetirizine was given for the itch. Y 01/10/2001 01/19/2001 9 PVT PVT URI and Diarrhea allergy to Amoxicillin 1
0165459 01/31/2001 FL 1.2 1 .3 M 01/22/2001 1/2 dollar-sized reddened area to injection site. Irritable and fussy. Temperature 99F. Gave Tylenol, Advil and cool compresses. Y 01/19/2001 01/20/2001 1 NONE PVT PVT NONE 1
0165460 01/31/2001 AZ 1.2 1 .2 M 01/24/2001 1-2 days, post vax, pt had redness and rash over and around the injection site which progressed to rash all over body. Pt was on Amoxicillin concurrently from 1/8/01 thru 1/18/01 and rash persisted even after antibiotic was completed. Dx'd with allergic rash. Benadryl for treatment started on 1/23/01. Y 01/12/2001 01/14/2001 2 OTH PUB Amoxicillin Resolving otitis media NONE 1
0165461 01/31/2001 CA 1.0 1 .0 F 01/24/2001 36-48 hours, post vax, pt had acute gastroenteritis. Symptoms began with vomiting and diarrhea and lasted 7-10 days. Episode #2 lead to dehydration requiring IV hydration in the ER. Vaccines given on 10/6/00, 11/20/00 and on 1/11/01 was also given MMR II and Varivax. Y Y 01/11/2001 01/12/2001 1 PVT UNK NONE NONE 1
0165462 01/31/2001 VA 1.25 1 .3 M 01/25/2001 On 1/11/01, in the afternoon, pt looked flushed and had a temperature of 103.9F and was irritable. Temperature came down to 102.9F with Tylenol in 1 hour but then took a bath after which he starting shaking his head side to side and shook his arms in rhythmic and tremulous fashion. His eyes were not focused. The episode lasted 1 minute. No tonic/clonic movement. Y 01/02/2001 01/11/2001 9 MIL MIL NONE Mild cough NONE 1
0165463 01/31/2001 CA 1.0 1 .1 M 01/11/2001 Pt had rash on face, chest and legs, on and off of back X 24 hours with hives on body parts. Y 01/10/2001 01/11/2001 1 NONE PVT PUB NONE NONE NONE 1
0165464 01/31/2001 CA 1.3 1 .3 M 01/23/2001 Febrile seizure with staring spell that lasted about 7 minutes, then 1 minute of tonic/clonic movements. Episode stopped at 8 minutes and was given rectal valium. Entire episode most likely unrelated to shots as pt went on to develope fever, URI symptoms, slight sore throat and then pink papular-macular rash after the fever resolved. All this most consistent with roseola. Y Y 01/16/2001 01/16/2001 0 Blood cultures and urine cultures-both neg PVT PVT NONE NONE 1
0165465 01/31/2001 PA 1.6 1 .0 F 01/25/2001 20 scattered vesiculo-pustular lesions on neck and back. Approx. 20 lesions on torso. Y 06/16/2000 01/06/2001 204 NONE PVT PVT Ceftin Bilateral Otitis Media Allergy to Augmentin causes hives. 1
0165466 01/31/2001 TX 1.0 1 .2 M 01/23/2001 Pt developed a fever to 103-104F, 8 days, post vax. 10 days, post vax, developed an erythematous maculopapular rash on trunk then spreading to groin and then to neck and face. Finally it has spread to extremities. U 01/12/2001 01/20/2001 8 PVT PVT NONE NONE NONE 1
0165467 01/31/2001 OK 20.0 20 M 01/19/2001 The following day, post vax, pt had soreness in the area of injection. For the next 3 days, I felt the same soreness. I was also unable to move my arm. There was a big red spot about 4" where I received the shot. Pain was so sharp I could not sleep. Y Y 01/09/2001 01/09/2001 0 NONE MIL MIL NONE NONE NONE 1
0165468 01/31/2001 MD 66.0 66 M 26-28 hours, post vax, had extreme diarrhea that lasted 5 days, off and on. 28-30 hours, post vax, had vomiting which returned after any solid food eaten, for 5 days. Then I got a 2 week head cold. Y 12/13/2000 12/14/2000 1 PVT PVT NONE 1
0165469 01/31/2001 GA 36.0 36 F 01/23/2001 On 11/27/00, received vaccine in left deltoid and since that time, has had pain in arm radiating into fingers. Complained of joint pain especially at night and difficulty in lifting and opening jars. Y N 11/27/2000 11/29/2000 2 NONE PVT PVT Reglan NONE GERD 1
0165470 01/31/2001 MA 77.0 F 01/18/2001 On 12/11/00, at 14:00, pain started in shoulder of arm and went down to wrist. As of 1/10/00, pain continues. Saw MD X 2, orthopedist X 1 and received cortisone shot on 1/10/01, with good relief. Y 12/11/2000 12/11/2000 0 PUB PUB UNK NONE Allergic to strawberries; has had a cardiac bypass. 1
0165471 01/31/2001 KY 38.0 38 F 01/19/2001 Pt developed an area of redness at the site of injection. The area was 6.25cm X 5cm. There was no itching or swelling but the area was warm to the touch. Y 11/20/2000 11/20/2000 0 MIL MIL Deconamine, Nasonex, Allegra, nortriptyline, Neurontin, Gaviscon Allergy to Erythromycin 1
0165472 01/31/2001 KY 53.0 53 M 01/19/2001 Following vaccination, pt developed an area of redness (15cm X 10cm) which was warm to the touch. No induration was noted. The pt noted tingling in the fingers for a 24 hour period. 11/28/00 Y 11/28/2000 11/28/2000 0 MIL MIL 1
0165473 01/31/2001 KY 42.0 42 F 01/19/2001 Post vax, on 11/28/00, the pt quickly developed a 6cm X 2cm area of redness, without induration. The are was warm to the touch but subsided quickly. Y 11/28/2000 11/28/2000 0 MIL MIL 1
0165474 01/31/2001 KY 43.0 43 F 01/19/2001 Five minutes, post vax, the pt reported light-headedness. She was instructed to take deep breaths and elevate feet. A physician was notified and came to review the situation. She later reported numbness in both arms, nausea and increased pressure in the back of her head, neck and lower skull. In a matter of minutes, pt progressed to a state of semi-consciousness. Pt was transported to the ER. Y Y 11/21/2000 11/21/2000 0 MIL MIL Allergy to gold sodium thiosalicylate 1
0165475 01/31/2001 KY 53.0 53 F 01/19/2001 Within 36 hours, post vax, pt developed localized swelling at the injection site. No itching, soreness or induration noted. Y 11/28/2000 11/28/2000 0 MIL MIL Celebrex, Lotensin, Estrogen 1
0165476 01/31/2001 SD 39.0 39 F 01/23/2001 Post vax, right deltoid became red, itchy and with 50 cent-sized induration. PO Benadryl taken. Thirty minutes later, "throat feels swollen and harder to swallow". Escorted to ER in hospital (next door) and they were too busy to see her for 1/2 hour. She worked at the clinic. Symptoms subsided with no reoccurrence. Y Y 12/07/2000 12/08/2000 1 NONE PVT PVT Synthroid, BCP NONE NONE 1
0165477 01/31/2001 TX 87.0 87 F 01/23/2001 Area below right deltoid became very red, warm to touch and edematous. This lasted X 2 days. Onset was 1 day, post vax. N 01/03/2001 01/04/2001 1 NONE OTH PUB Neurontin, Aricept, Coumadin, Altace, Prilosec, Effexor Allergies to Cipro, Cortizone, PCN 1
0165478 01/31/2001 PA 83.0 84 F 01/24/2001 Sudden onset of right facial paralysis on 1/8/01. Seen in ER and Rx'd prednisone, Lacrilube and Natural tears. Symptoms and facial droop are improving but not resolved at this time. Dx'd with Bell's Palsy. Y N 12/27/2000 01/08/2001 12 CBC; BUN; CR; Glucose-all nml; CT of brain-no stroke; Carotid US-no significant stenosis PVT PVT Toprol XL, ASA, Calcium, Norvasc, multivitamins NONE Allergy to PCN, hypertrophic cardiomyopathy, hypertension, coronary artery disease 1
0165479 01/31/2001 WI 50.0 48 F 01/24/2001 On 12/29/00, had dry throat, hives on right wrist, inside of knees, buttocks and hips. On 12/30/00 and 12/31/00, had sore throat and dry cough. Y 12/26/2000 12/29/2000 3 PVT UNK NONE NONE 1
0165480 01/31/2001 TX 68.0 68 F Rash-like heat rash appeared around waist and spread to legs, feet and to arms last. Did not get on my face, neck, chest or bottoms of feet or scalp. Under doctor's care since onset. Treated with 2 shots, pills and cream (methylprednisolone and triamcinolone). The 2 doctors who have treated me, don't know the cause of this rash which is almost gone except for a small patch on my leg and fading spots on top of my feet. Since I had called about this and it was in the time frame of the flu shot, I completed the form. Y 11/16/2000 11/21/2000 5 2 Blood tests-neg PUB UNK 1
0165481 01/31/2001 MS 24.0 24 F 01/25/2001 Nausea, severe headache, soreness at injection site, swelling behind right knee and above left knee. Y 01/17/2001 01/18/2001 1 NONE PVT PUB NONE Allergy to penicillin and iodine. 1
0165482 01/31/2001 WA 36.0 36 F 01/22/2001 Headache and nausea started on 1/19/01. Y 01/19/2001 01/19/2001 0 OTH OTH NONE NONE 1
0165483 01/31/2001 NJ 53.0 52 F 01/22/2001 No data provided. Y 01/08/2001 01/22/2001 14 NONE PUB PUB tamoxifen, Lipitor Breast cancer; high cholesterol 1
0165484 01/31/2001 PA 7.0 2 .5 M 01/23/2001 Pt had slight case of chickenpox after having varicella vaccine in 1995. Y Y 11/21/1995 12/21/2000 1857 NONE PVT PVT NONE NONE NONE 1
0165485 01/31/2001 NY 14.0 14 M 11/14/2000 23 days, post vax, developed hives, angioedema, malaise and swelling and coldness of hands. Resolved after Benadryl, only to have hives occur again, 4 days later. Otherwise, experienced only a slight fever, post vax. with prior Rabavert doses. Mother reports he had an allergic type reaction following exposure to coyotes but before he received any rabies vaccination Y U 10/17/2000 11/10/2000 24 PUB PUB Depo-Medrol, Atarax Swelling of face NONE 1
0165486 01/31/2001 MA 5.0 5 M 01/29/2001 Redness and edema of the area and warm to touch; measuring 11 1/2cm X 6 1/2cm. Was told to use ward packs. Phone call to mom on 1/29/01; she states area looks much better. Y 01/25/2001 PVT PUB Augmentin Otitis Media Chronic Otitis Media 1
0165487 01/31/2001 TX 1.25 1 .3 F 12/14/2000 Irritability (onset 12 hours, post vax; duration approx. 48 hours), diarrhea (onset 4-6 hours, post vax; duration 8 hours), fever (onset 12 hours, post vax; 102F axillary; fever remained around 100F for 24 hours). Treatment: diarrhea-diet changes/fluid increase and fever-ibuprofen. Y 12/12/2000 12/12/2000 0 MIL MIL NONE NONE NONE 1
0165488 01/31/2001 IA 1.3 1 .3 M 01/24/2001 Fever of 102.7F. Motrin given at that time and continued with Motrin X 48 hours. On 1/21/01, red rash (mainly on neck and stomach and then the back. Back had bumps. Right leg had fluid filled-yellowish. Y 01/06/2001 01/19/2001 13 PUB PUB Amoxicillin; started on 1/15-1/22 Bad cough, stuffy and runny nose NONE 1
0165489 01/31/2001 OH 1.0 1 .1 F Pink, non-raised, generalized rash over abdomen, back, eyes, ears and spotty at legs and arm. Temperature 101.4F. U 01/22/2001 01/22/2001 0 NONE PUB PUB NONE 1
0165490 01/31/2001 CA 1.5 1 .6 M 01/17/2001 Local reaction from knee to groin; swollen, red, warm almost circumferential around thigh. Y 01/15/2001 01/16/2001 1 NONE PVT PVT NONE NONE Amoxicillin causes a rash. 1
0165491 01/31/2001 WV 0.2 0 .2 F 01/25/2001 Unconsolable crying > 4 hours. Y Y 11/13/2000 11/13/2000 0 PVT UNK NONE NONE 1
0165492 01/31/2001 MI 36.0 36 F Two days post vax the pt developed a rash or hives on leg. The rash progressed to whole body. Pt experienced a rash with a previous dose. Y N 01/16/2001 01/18/2001 2 NONE PUB PVT Klonopin; Flexaril; Estrace NONE Fibromyalgia 1
0165493 01/31/2001 CO 0.3 0 .4 F 12/22/2000 Pt experienced inconsolable crying for 4 hours. No treatment was given; self resolved. Y Y 12/21/2000 12/22/2000 1 MIL MIL NONE NONE 1
0165494 01/31/2001 WA 0.2 0 .2 F 01/23/2001 Pt experienced inconsolable crying. Y 01/22/2001 01/22/2001 0 NONE PVT PUB NONE mild upper respiratory illness NONE 1
0165495 01/31/2001 OR 3.0 3 F 01/24/2001 Six days post vax, the pt developed papulovesicular rash on erythematous base consistent with varicella. Y Y 01/10/2001 01/16/2001 6 NONE PVT PVT NONE NONE NONE 1
0165497 02/01/2001 TX 23.0 23 F 01/23/2001 The mother states patient had a headache and had been vomiting and collapsed.Mom found her unrepsonsive. Went to ER found blood in head. Went by care flight and 2nd hospital for surgery attempted; didn't wake, worse bleeding from "abnormal plexus of veins" in cerebellum patient expired. Death certificate states cause of death to be cerebral herniation due to rupture of cerebellar arteriovenous malformation. Y 11/26/2000 N 11/21/2000 11/26/2000 5 NONE PVT PVT Celexa depression, stress reaction seasonal allergies, stress reaction, depression 1
0165498 02/01/2001 ME 14.0 13 M 01/25/2001 The pt experienced fatigue, joint and muscle pain, abdominal pain, poor appetite, muscle weakness, skin rashes, fever, headache, inability to concentrate, memory loss, sleeplessness, and nausea. Y Y U 06/30/1998 08/30/1998 61 It was said that the patient had Mono symptoms . Then later he tested positive for Mono after the third shot. CT/abdomen with contra-normal examination. PVT PUB NONE NONE NONE 1
0165501 02/01/2001 NJ 45.0 45 F 01/29/2001 Report 2001001167-1 describes brachial plexitis and herniated nucleus pulposus of the thoracic spine (T3-T4) with radiculopathy in a 45 year old female who received Lymerix. On 07/01/99 (left deltoid), 08/02/99 (left deltoid) and 10/12/00 (site nos), the patient received her first, second, and third doses of Lymerix, respectively. On an unspecified date "earlier in the year", the patient experienced back pain and hip pain. On 10/14/00, the patient developed a "burning, painful" paresthesia of her upper chest and right arm. She was able sleep at night only when she placed her right arm above her head and off to the side. To the patient's recollection there was no prior trauma and she had no repetitive activity the day before or even the week before these symptoms began. On 10/15/00, the pain moved into the right side of her back involving the shoulder blade area. She did not have shortness of breath. She was seen by her physician later that day, and the diagnosis of inflammation of the chest wall was made. Her skin seemed very sensitive at the time. She was treated with Nabumetone (Relafen) and Dextropropoxyphene / paracetamol (Darvocet), which seemed to ease the discomfort somewhat. She stayed home from work the next three days. Her medications were changed at this point to Oxycodone Hydrochloride (Percocet) and Famcyclovir (Famvir). The patient was evaluated by her physician, who identified no objective findings consistant with nerve or muscle injury. Her ESR, CRP, and RF were all normal. On 10/23/00, the patient was evaluated by an orthopedic surgeon, who excluded a thoracic outlet syndrome. The diagnosis of "muscular skeletal pain" was made. On 11/03/00, the diagnosis was changed to costochondritis and neuropathic pain. She was treated with Oxycodone Hydrochloride (Percocet) and Lidocaine patches. Neither of these helped. A neurologist diagnosed brachial plexitis, rule out cervical radiculopathy, rule out thoracic radiculopathy. On examination, "the only bothersome finding" is the subjective decrease to pinprick on the right between T2 and T5. The neurologist prescribed Methylprednisolone (Medrol Dosepak). The patient received treatment with NSAID's (nos), Doxycycline, and Famcyclovir (Famvir), all without improvement. Gabapentin (Neurontin) has lessened the pain only slightly). On 12/20/00 she under went an MRI of the brain with and without contrast which was normal. A bone scan on 12/06/00 was also normal as well as a rib x-ray on the same date. An MRI on 11/20/00 yielded evidence of a tiny posterior T3-T4 herniation indenting the ventral aspect of the spinal cord in the thoracic region. On 12/27/00 and 01/15/01, the neurologist stated that the 11/20/00 thoracic MRI finding "might result in some radicular complaints and it is possible that this lesion is responsible for some of the patient's symptomatology." "At the time of the patient's last examination on 12/04/00", the neurologist stated, "there was no evidence of long track involvement that would suggest a spinal cord myelopathy." The EMG / nerve conduction study right demyelinization of the right median and ulnar nerve between Erb's point and the axilla. Diagnosis: 1. Right brachial plexitis. 2. Herniated nucleus pulposus of the thoracic spine (T3-T4) with radiculopathy. The patient felt that her symptoms were related to Lymerix. The treating physician was "not so sure". The case is considered incapacitating because the patient has been unable to work. As of 01/24/01, the outcome of the events is ongoing. Y N 10/12/2000 10/14/2000 2 ESR, CRP and RF-all nml; 12/20/00 pt had MRI of the brain with and without contrast which was nml; 12/6/00 Bone Scan and rib studies-nml; MRI on 12/20/00 yielded evidence of a tiny posterior T3-T4 herniation indenting the ventral aspect of the spinal cord in the thoracic region. EMG/Nerve conduction study of right upper extremity performed on 1/12/01-segmental demyelinization of the right median and ulnar nerve between Brb's point and the axilla. OTH OTH danazol, Estratest Adenoidectomy; mitral valve prolapse; partial hysterectomy with fibroid cyst; pectus excavinatum surgery, right breast calcium cluster surgery, right carpal tunnel surgery; sinus problems (pain and pressure around eyes); tonsillectomy 20010011671 1
0165502 02/01/2001 VA 19.0 19 M 01/17/2001 On 8/1/00, pt was vaccinated and in August, 2000, the pt developed chills, felt feverish and weakness. The pt went to his doctor's office and had a pulse of 124, BP 94/66 and fever of 100.2F. The pt was treated with Benadryl IV and Motrin. That night, the pt had an increase in temperature, felt feverish, chills, nausea and weakness and ended up in the ER. His BP was 82/56. He was hydrated with normal saline, Benadryl po, Solu-Medrol and Phenergan. The pt was in the ER for 3-4 hours and was sent home on oral prednisone. The reporter stated that the pt is "now much improved" although he still feels tired and "not himself". ER records, on that date, noted that the pt had received the Hep-B vaccine and 30 minutes, post vax, began feeling shaky and developed a fever. It was noted that the pt had a decreased appetite, body aches and was hyperventilating and tachypenic. It was noted that the pt's throat was slightly erythematous and the airway was slightly "full". He was given 2L oxygen via nasal cannula and placed on a cardiac monitor. The pt was also given Tylenol for a temperature of 102.9F. The pt was placed on 10L NC of O2. The dx was acute allergic reaction to Hep-B vaccine. The pt was advised to avoid the other 2 shots of Hep-B, drink fluids and take Tylenol for fever. Prednisone 40 mg, 1 X a day for 5 days was prescribed. Upon internal review, the pt's "acute allergic reaction to Hep-B IZ" was considered to be an "Important Medical Event". No further information is available. Y Y 08/01/2000 08/01/2000 0 CBC and SMA 7; Abnormal results included; carbon dioxide 22, calcium 10.3 (high), seg neutrophils 86 and lymphs 6. Heartbeats-143 PVT PVT Ventolin inhaler, Allegra Allergic rhinitis; asthma; meperidine allergy WAES00080606 1
0165504 02/01/2001 TX 1.5 1 .6 M 01/24/2001 Information has been received from a consumer concerning a 16 month old male who on 8/1/00, was vaccinated with MMR II and DTP. On 8/3/00, the pt developed a red rash that "looked like measles" on his trunk, arms and legs. On 8/4/00, the pt developed diarrhea. The pt's mother reported that the "diarrhea is now chronic with bloody stool". A colonoscopy was performed on 12/29/00, which revealed a dx of lymphnodular hyperplasia, intestines. The pt's mother reported that the pt had no prior history of diarrhea. Upon internal review, the pt's lymphnodular hyperplasia, intestines was considered to be an "Other Medical Event". The pt also developed a runny nose, which has persisted. The pt was treated with Diflucan, starting 10/00, ranitidine starting on 12/29/00 and Zyrtec starting on 12/29/00. Treatment with these therapies continued as of 1/12/01. The consumer reported another child who experienced events following vaccinations with Hep-B vaccine recombinant (yeast) (MSD WAES01011262), MMR II (MSD WAES01011263) and varicella vaccine (MSD WAES01011264). Additional information has been requested. Y N 08/01/2000 Colonoscopy on 12/29/00-revealed lymphnodular hyperplasia, intestines UNK UNK UNK WAES01011080 1
0165505 02/01/2001 TX 1.25 1 .3 M 01/24/2001 Information has been received from a consumer concerning a 15 month old male who on 3/4/98 was vaccinated with MMR II. On 3/9/98, the pt developed diarrhea. The pt was treated with Diflucan. The dx was chronic mucous candidiasis. The pt also "stopped talking for months" after receiving MMR II. The pt's mother reports no prior history before this episode. The pt was treated with Zantac that started on 11/00, Zyrtec that started on 12/00 and Diflucan. Treatment with these therapies continue. Upon internal review, the pt's experiences were considered to be an "Other Medical Event". The pt subsequently, experienced product misuse following vaccination with varicella virus vaccine live (MSD WAES01011264). The consumer reported another child who had an experience following vaccination with MMR II (WAES01011080). Additional information has been requested. Y U 03/04/1998 03/09/1998 5 UNK UNK UNK UNK Candidiasis; diarrhea; oral candidiasis; drug allergy WAES01011263 1
0165507 02/01/2001 LA 70.0 70 F 01/24/2001 This patient's family indicates that she is now being transferred to the rehabilitation unit to continue her recovery from her neurological illness. The patient was originally transferred to medical Center on 01/01/01. The patient's symptoms actually began on 12/26/00 when she began a syndrome of nausea, emesis, and a productive cough. The patient deteriorated until 12/31/00 when her husband noticed that she was very disoriented, that she was unable to sit up, she was unable to transfer without the patient's help. Because of this and the continuing complaint of headache the patient was seen at another Hosp where she was admitted. The patient was initially given Rocephin and a lab work up was done. The patient's admitting physician noted her to be stuporous, but responsive until the night time hours when she gradually became less responsive. It was also noticed by the Physician that she was having difficulty with movement of her right eye, the right eye coming to the midline. The patient was also having a tendency to keep her head deviated to the left side, though she was moving her arms and legs. With this history she was transferred to Medical Center. Her initial physical examination revealed her to be mildly febrile, temp of 100F, with snoring respiration's and upper airway noise. She would open her eyes with pain stimulation and when deep suctions, though her eyes would not attempt to follow any commands. Her oral airway mildly compromised with oral secretions. Her neurologic exam revealed her to be unresponsive but would open her eyes briefly with pain and with strong verbal stimulation. The patient's moved both arms and legs after passive range of motion. The patient's reflexes were one to two plus and symmetrical. Plantar stimulation was flexor on the right, questionably up going on the left. It was felt that the sixth nerve palsy was a false localizing sign and so the patient under went diagnostic studies. Ct scan of the brain and an MRI of the brain was done. The MRI showed areas of abnormality in the floor of the fourth ventricle at the pontomedullary junction. Lumbar puncture was done, routine diagnostic studies showed an elevated spinal fluid protein, but more impressively showed marked elevated fluid IGG synthesis. The patient developed respiratory distress and had to be intubated to protect her airway. She was treated with antibiotics in addition to the Rocephin. Over the next several days the patient was maintained on a ventilator, then she became more arousable was able to be extubated; the released from intensive care. The patient was moved to a regular room more alert but at times confused and disoriented. The patient has finally become aware of diplopia as the right sixth cranial nerve palsy has persisted. The neuro team has been seeing the patient and has noted she is unable to sit , stand or transfer unsupported. All medication were discontinued as felt necessary as the patients spinal fluid cell count was 0. Further history from the patient has indicated that she had a Flu vaccine two weeks before the onset of these symptoms. The patient has been referred for a comprehensive rehabilitation program; length of stay two weeks. Y Y Y 11/27/2000 12/26/2000 29 CT scan of brain, MRI of brain - abnormal, lumbar puncture - elevated spinal synthesis, bronchoscope, PVT PVT Celebrex , Prinivil, Aspirin, Tenormin, Estratab. Medications on Transfer: Lopressor, Lanoxin, Zestril, Dilantin, Zantac. NONE NONE 1
0165508 02/01/2001 VA 0.3 0 .3 M 01/26/2001 This infant had a fever of 102.5. Y 01/16/2001 01/16/2001 0 NONE PVT PVT Diflucan (started 01/16/01) Nasal congestion, well baby Healthy former 34 week premie. 1
0165509 02/01/2001 CA 1.3 1 .3 F 01/18/2001 This infant had vaccine, 5 hours after vaccination she had hives, and facial swelling. The patient had to be seen again. She improved with Benadryl. Y U 01/17/2001 01/17/2001 0 NONE PVT UNK NONE ICG Sensitivity 1
0165510 02/01/2001 CA 1.7 1 .3 F 12/21/2000 On the evening of 12/15/00 the patient had a fever of 103, alert and oriented times three. On 12/16/00, Saturday AM the patient woke up with swollen right arm and rash all over her body. She was taken to the ER. The patient was treated for an ear infection and bronchitis. Calamine lotion to the rash, no mention of allergic reaction, temperature 97. Y 12/15/2000 12/16/2000 1 NONE OTH OTH NONE NONE 1
0165511 02/01/2001 TX 19.0 F 01/19/2001 Vaccine was given to the child's mother in the first trimester of her pregnancy. The child seen in consultation by the doctor 12/28/00 and diagnosis is pervasive developmental disorder, nos. The follow up received on 8/15/01 states please note that this case has a duplicate VAERS number (second VAERS number assigned to this case is VAERS reference 166116). The pt in this case was a 19 year old female who received the Anthrax vaccine during her pregnancy. Her daughter was diagnosed with PDD. Follow-up info received from the child's pediatrician noted that the child had improved, but a full recovery is not expected. N MRI of the brain and urine screen for amino and organic acids - pending Chromosome analysis - Nml MIL MIL UNK UNK 1
0165512 02/01/2001 IL 41.0 41 F 01/04/2001 This patient complained of flu like symptoms, ie : chills, mild diarrhea, GI discomfort, back and spinal pain, severe dizziness (spinning room) for almost 12 hours, no fever. The symptoms started 3 days after her injection and lasted about 4 days. No treatment was given. Y 12/27/2000 12/30/2000 3 NONE OTH OTH NONE Allergic to Penicillin, Bactrim, Fluoroguinolunes 1
0165513 02/01/2001 FL 52.0 52 F 01/30/2001 This patient had bilateral pedal edema. Y Y 12/07/2000 12/07/2000 0 OTH OTH Insulin, ASA, Nonase, Primivil, Glucotrol XL, Metformin. Type II diabetes mellitus, hypertension, asthma. 1
0165514 02/01/2001 GA 89.0 89 F 01/30/2001 This patient had flu like symptoms, splotches on legs, numbness in feet, weakness, and vasculitis. N 10/02/2000 10/02/2000 0 ESR 66, Skin biopsy And Vasculitis. OTH PVT NONE NONE 1
0165515 02/01/2001 OH 50.0 50 F 01/17/2001 This patient had a red swollen patch 1" wide by 2" across, heat and pain in area; shortness of breath, paleness. The physician stated 1 1/2 " wide by 3" across, local not systemic. Y Y 01/15/2001 01/15/2001 0 OTH PVT Synthyroid, Cytomel NONE NONE 1
0165516 02/01/2001 MO 30.0 10 F 10/15/2000 The patient had shots, ten minutes later she had "light headedness, heart beating fast, hard to breathe, feels like anxiety attack". The !st dose of epi given 0.3 cc symptoms began to subside. Symptoms still occurring after another 5 minutes. She was given 2nd dose of epinephrine sq symptoms: difficulty breathing continued, administered 3rd dose of epinephrine after another 7 minutes. Emergency staff began arriving about 5-10 minutes later. Administered oxygen and a breathing treatment, transported the patient to Independence Regional Hospital Emergency room. She was released that afternoon. Y Y 10/15/2000 10/15/2000 0 Most ambulance and Independence Regional would have this info. OTH PVT Took Allegra in the AM NONE NONE 1
0165517 02/01/2001 CA 46.0 57 M 01/09/2001 This patient had a fever, body muscle aches, headache, general symptoms of the flu, mild to moderate. Y 12/18/2000 12/19/2000 1 OTH OTH NONE NONE 1
0165518 02/01/2001 TX 32.0 32 M On 12/25/00 the patient had symptoms of hives on pelvis, back of legs; it worsened, and his feet swelled. She went to the ER. The patient was given Benadryl and steroid injection at 6 PM. On 12/27/00, hives on pelvis, and back of his legs again. Later that evening after he went to see his own private doctor his lips started swelling. On 12/29/00, his doctor prescribed Prednisone tablets and Zantac for 10 days. By 12/30/00, his symptoms had resolved. On 12/07/00, the patient had an Influenza injection by an outside vendor. Unable to get any information from the vendor at the present. Y Y 12/15/2000 12/25/2000 10 OTH PVT 1
0165519 02/01/2001 CA 2.0 M 01/19/2001 Mother states that her son has a dent in his leg. She took him to see the doctor on 01/02/01. She said it was caused by a vaccine. She couldn't tell me which vaccine would have caused it. She said it was showing up now because he is growing. She said it has damaged a muscle. This was not listed on any consent form as a possible side effect. N OTH OTH NONE NONE 1
0165520 02/01/2001 FL 32.0 32 F 01/30/2001 This patient had redness and edema at the injection site (right arm). Y Y 10/30/2000 10/30/2000 0 OTH OTH Insulin UTI Type I diabetes mellitus, asthma. 1
0165521 02/01/2001 LA 43.0 43 F 01/18/2001 This patient received Td vaccine in her right deltoid. Two days later she notes a small hematoma; she applied ice at that time at 2:30 PM. The site was red, swollen warm, and raised. Y 01/16/2001 01/16/2001 0 PUB PUB Precose, Synthyroid, Effaxtor. PPD Pasteur / Connaught (CoK50AA) left deltoid. Hypothyroidism, anxiety, hypoglycemia 1
0165522 02/01/2001 GA 1.7 1 .6 M 01/24/2001 This child diagnosed with chicken pox 01/22/01, after vaccine 07/10/1996. Y Y 07/10/1996 01/22/2001 1657 PVT PVT 1
0165523 02/01/2001 CA 15.0 15 F 01/25/2001 This patient has seizure, paleness, weakness, dizziness, fast heart beat, fainting. Had Benadryl injection (IM) Ammonia inhalant, and Benadryl tab, a lot of fluids, water, rest recovered after thirty (30) minutes. Y 01/16/2001 01/16/2001 0 NONE PVT PUB PPD Mantoux, Parkedale, ID left arm, 2 doses, lot #0830P NONE NONE 1
0165524 02/01/2001 NY 43.0 43 F 01/19/2001 The patient was given Engerix-B Hepatitis B vaccine was given to this employee and approximately 30 minutes later she complained of "funny taste in her mouth", with a sensation of "difficulty swallowing", soon was complaining of tingling around the lips, felt she wasn't able to "talk right". She was sent to the local ER, given antihistamine while there sent home with a prescription of Zyrtec. Reported that later she developed a rash on her wrist and tingling at the tips of her fingers. She had no difficulty breathing, and no obvious swelling of the mouth. . Y Y 01/19/2001 01/19/2001 0 OTH PUB Glucophage, Glucotrol XL Diabetes Mellitus, past yeast infections - prolonged 1
0165525 02/02/2001 AL 4.0 4 F 12/09/2000 The pt was found in bed at home without a pulse of respirations at 8:00 am on 12/9/00. She was given a glucogon injection and CPR was started and continued until EMS arrived. The pt was intubated and 2 doses of epinephrine and 1 dose of atropine were given during transport to the ER. The pupils were fixed and dilated. At the ER, the pt received epinephrine and atropine in the ER. The pt expired at 9:30 AM on 12/9/00 with cause of death being cardiopulmonary arrest. The pt had taken the normal dose of insulin on 12/8/00 with an accucheck of 147 at 10:20PM on 12/8/00. She had received the flu vaccine at 3:00PM on 12/8/00 in the physicians office. Death certificate states cause of death to be cardiopulmonary arrest. Autopsy report states: pulmonary vascular congestion and edema. Y 12/09/2000 N 12/08/2000 12/09/2000 1 UNK UNK insulin in AM and PM type I diabetes 1
0165528 02/02/2001 MA 43.0 43 F 01/21/2001 After administration of 2 injections of Lymerix the pt developed chronic joint pain, arthritis theorized to be caused by the Lymerix vaccine. This joint pain has been unresponsive to physical therapy, cortisone injections. 60 day follow-up states that the doctor thinks the pt may have had a low level case of Lyme Disease prior to receiving the vaccine and the vaccine reactivated the disease. The follow up received on 6/14/01 states, "a 42 yea rold nurse from the hospital presenting wiht pain involving the left hip similar to what she's had in the past. She is anxious to get another injection because shehas activities planned that will involve a lot of walking and moving about. So, therefore, after examination continues to show that she is very tender over the lateral aspect of the left greater trochnter she is carefully injected using sterile technique with Depo Medrol and lidocaine into the point of maximum tenderness and distal proximal injecting to the bone and then backing off so as to interset the bursa with at least some of the injected materials. She understands we can't guarantee results and that recurrence might happen. I can't think of any good surgical options for her and I don't think x-rays are indicated because she has a full and normal range of motion otherwise. She is advised it may be very painful fo ra day or two. She will see mee prn. Pt did not have very good relief from the injection last time and her tenderness is not right over the superficial portion of hte trochanteric bursa but rather appears deeper in the area of the gluteal bursae. She is given a more superficial Xylocaine injection but still has pain on deep presure despite the anesthetic agent being in the more superficial area of the bursa. She is therefore treated with a spinal needle by injection of the gluteal bursae with DepoMedrol, Xylocaine, and Marcaine and hopefully this will work. She will let me know how she does. The pt was not helped by the Depo Medrol injection last time. Her tenderness is somewhat deep and slightly proximal to the tip of the trochanter and may involve the gluteal bursa. She is treated with Xylocaine injection first in the area of the rochanteric bursa and this still has tenderness deep. Therefore the Depo Medrol and Xylocaine and Marcaine are injected both into the trochanteric bursa as well as the gluteal bursa and she will be seen again prn. The pt has a good result following injection of the trocahnteric bursa of the left hip. She now has recurrence of her symptoms and has been treated again by Depo Medrol injection. She is warned that she might have to have resection of the bursa, but we will wait and see how she does." Y N 06/03/1999 07/01/1999 28 x-rays, MRI, bone scan - all neg UNK UNK Migraines; s/p dysmenorrhea 1
0165529 02/02/2001 NJ 0.7 0 .7 M 01/19/2001 Mother states, post vax, child would not move leg and held hip and knee flexed. On 1/11/01, right knee swollen, warm and with pain on movement. Right hip had normal ROM. No fever. Admitted to rule out septic joint and toxic synovitis. Dx: Toxic Synovitis. Y 6 Y 12/18/2000 X-ray-nml on 1/4/01; MRI of knee-nml; Bone Scan-nml; Tap of knee consistent with effusion; ESR-40; WBC-16,000 and 72% lymph PVT PUB NONE NONE NJ20011 1
0165537 02/02/2001 NJ 1.0 1 .0 M 01/25/2001 The pt had a seizure at home under 1/2 min. The pt also experienced a fever of 102.4, blood pressure rose to 106 in ambulance. The pt was taken to the ER. Y Y 1 Y 01/22/2001 01/22/2001 0 PVT OTH anbesol for teething NONE 1
0165538 02/02/2001 NY 1.0 0 .8 M 01/31/2001 The pt vomited three times and had diarrhea one time the afternoon of the day the vax was given. Y 10/12/2000 10/12/2000 0 PVT PVT NONE viral cold symptoms NONE 1
0165539 02/02/2001 OR 45.0 45 M 02/01/2001 On 12/2/00, this pt developed right parascapular pain and on 12/6/00 developed right hand weakness and dyscoordination. He has specific weakness of thumb and abduction of fingers with decreased pinch and grip strength. A c-spine MR was performed and did not explain symptoms. A MRI of his brain is pending. A tentative diagnosis has been made of brachial plexitis. F/U rec'd fromreporter 6/27/01 via telephone. the reporte ? that she rec'd f/u info consisting of the following. the pt has not fully recovered and has regained 70% of his strength in the R arm and shoulder and still experiences pain in the R arm requiring daily use of motrin. The pt is seeing a neurologist. No other info was available, further inof requested from the reporter. U 10/10/2000 12/02/2000 53 OTH OTH Lisinopril hypertension MPI2001000310 1
0165540 02/02/2001 WI 27.0 27 M 01/26/2001 This patient has history of [[name]] Barre' Syndrome with residual symptoms of leg pain and leg spasms. His girlfriend read Influenza information sheet after he received the Flu shot and she became concerned that the patient's residual symptoms were worse after his flu shot. The patient denies that his symptoms are worse, he was evaluated by the doctor who ruled out [[name]] Barre Syndrome or exacerbation of residual symptoms of the syndrome. Hx of GBS as teenager, residual pain in leg- spasma also tendonitis of wrists. U 12/21/2000 NONE PUB UNK NONE history of Guillain Barre' Syndrome 1989 - 1990 1
0165541 02/02/2001 63.0 F On 12/01/00, the patient received Fluvirin vaccine in the left deltoid. Immediate pruritis at the site, Prescribed Ice. At 10 PM the axillary adenopathy, left arm acne. 12/02/00, malaise and flushed from 12 thru night and day: burning of both legs, PM of 12/02/00, at 6 PM gradually lost sensation, then strength in both legs (Sat evening). 12/3/00, unable to move legs by 12 AM, crawled to bedroom, later dragged in to be seen by MD at 10 AM (Sunday). U 12/02/2000 NONE UNK UNK Acetaminophen, Medrol History of allergies to vaccine 30 years previously (dust, alfalfa, moth, etc), environmental allergies, Foreign protein reaction, fever, adenopathy, Polyarthralgia. 1
0165542 02/02/2001 77.0 77 F The patient received the flu shot on a Friday approximately 12/29/2000. Saturday morning the patient's arms and under arms broke out with red spots. In 3 days she was broke out all over her body. She went to the urgent care clinic the doctor said it was hives from the flu shot. She itched badly. She took medication 4 weeks then they were all gone. Y Y 12/29/2000 01/17/2001 19 UNK UNK NONE 1
0165543 02/02/2001 KY 44.0 44 F 01/19/2001 On Wednesday, 01/17/01, the patient's left arm ached from the site where the shot was given down her hand. Thursday,01/18/01, the pain was better but still sore at the injection site. Friday, 01/19/01, having numbness on the left arm down to the hand. Feels tired all over with dizziness. Y 01/16/2001 01/17/2001 1 NONE PUB PUB NONE States slight congestion NONE 1
0165544 02/02/2001 CA 56.0 56 F 01/09/2001 This patient has a runny nose, persistent bronchial cough, Phlegm in throat and chest, headache, eye hemorrhage in the left eye, no vision, vision unclear. Y Y 11/07/2000 11/19/2000 12 Laser surgery when Hemorrhage in left eye stops. PUB OTH Glucophage, Glyburide, Diovan, Levothrud NONE Diabetes, Thyroid, Hypertension. ~Influenza (Seasonal) (no brand name)~~64.00~In Sibling|~Influenza (Seasonal) (no brand name)~~61.00~In Sibling 1
0165545 02/02/2001 AZ 21.0 51 F Pt was seen by a local physician who recommended EMG. 07/26/01 Follow up. This information was faxed to VAERS 05/18/2001. Per health dept, the date of the adverse event was 12/21/2000 and thet time 07:30am. Y Y 12/21/2000 12/21/2000 0 PUB UNK NONE NONE AZ0102 1
0165546 02/02/2001 AZ 61.0 61 M 01/29/2001 15 hours after receiving immunization in the left arm the patient became swollen and painful with red splotchy rash. Within 48 hours symptoms subsided. Y 01/26/2001 01/27/2001 1 NONE PUB PVT NONE NONE NONE AZ0104 1
0165547 02/02/2001 NY F 01/17/2001 This patient received rubella vaccine but all lab results were negative from any rubella titer or evidence of any antibodies. U 02/14/2000 02/14/2000 0 UNK UNK 1
0165548 02/02/2001 MI 43.0 M 11/17/2000 This patient had 70 mm x 50 mm erythema, left deltoid, 70 mm x 60 mm induration, left deltoid. Decreased range of motion left arm with pain on abduction onset 6 hours post administration 11/15/00. Y Y PVT PVT Lasix, Corea, Altace, Claritan, weekly allergy injections. NONE Cardiomyopathy, environmental allergies. 1
0165549 02/02/2001 43.0 M This patient had a severe onset of localized reaction that began approximately 6 hours post injection. Initially painful adduction of the left arm with gradual increasing erythema and induration at the left deltoid; measuring 70 mm x 60 mm (induration). U 11/15/2000 UNK UNK NONE Cardiomyopathy, environmental allergies. 1
0165550 02/02/2001 76.0 76 M 01/16/2001 Pt experienced arthralgia/myalgia subsequent to receiving the second dose of Havrix, with gradual improvement over 5-7 days. 01/10/2001 01/11/2001 1 NONE UNK UNK 1
0165551 02/02/2001 TX 53.0 53 M 01/16/2001 Pt developed cellulitis and was treated with antibiotics. Y 01/09/2001 01/10/2001 1 NONE PUB OTH Hep C 1
0165552 02/02/2001 MI 60.0 60 F 12/27/2000 Approximately 2 hours post vax, the pt relates onset of rash and itching around both ankles. Pt states she was at work at wildlife refuge and notice symptoms while walking back to the house from animal cages. Rash initially appeared as discrete, red, raised dots. Pt denies SOB, wheezing, fever, nausea. Admits to malaise which started the day after vax was administered and lasted approximately 16 - 18 hours. Pt states arm was sore to touch following vax. After approximately one day, ankle rash evolved into welts which covered both ankles in a three inch band. Welts were not fluid filled but described by pt as wide and raised. Welts did not extend to feet or lower legs. Pt states she noticed a couple of similar welts across her back following the bra line. No other symptoms. Pt states she has been taking Benadryl and using topical cortisone to relieve itching. Ankles remain reddened and become itchy when warm. Y 12/20/2000 12/20/2000 0 NONE PUB UNK antihistamine; daily vitamin; estrogen; thyroid; Asthmacort NONE asthma 1
0165553 02/02/2001 IL 42.0 42 F 01/25/2001 Pt developed a 50 cent sized induration with redness at injection site. 2 days prior to observation pt states redness radiated to left axillary. Y 01/15/2001 01/15/2001 0 UNK UNK 1
0165554 02/02/2001 OH 0.4 0 .2 M 01/25/2001 Two days post vax, the pt developed a high fever of 103.4 degrees, seizures and experienced difficulty breathing. Y Y 10/05/2000 10/08/2000 3 PUB PUB NONE 1
0165555 02/02/2001 GA 57.0 57 F 01/26/2001 Pt states he didn't feel right after vax. The next day a knot the size of an egg developed and arm was painful. Pt directed to treat with warm compress, Advil and to rest arm. Pt seen in the office the next day for swelling, redness and pain in upper left arm. Pt treated with Biaxin. Symptoms didn't improve and pt was seen in the ER 10 days post vax. Pt was treated with Augmentin. Y Y 01/04/2001 01/09/2001 5 PVT PVT Estrace viral upper respiratory infection iodine and sulfa allergies 1
0165556 02/02/2001 LA 0.3 0 .4 M 01/31/2001 Within minutes of receiving vax, the DTaP injection site became red and swollen. Pt became splotchy on face, neck, behind ears and down to chest area. Pt was treated with Benadryl and ice packs at site of DTaP and Hib. Pt would continuously cry. Y Y 01/30/2001 01/30/2001 0 PUB PUB NONE NONE KY2001006 1
0165557 02/02/2001 IL 4.0 4 F 01/29/2001 One day post vax, the pt developed localized redness and swelling which progressively worsened. By two days post vax the pt had experienced a huge amount of swelling and redness extending to posterior aspect of leg. Pt seen by physician but no treatment given other than cool compress to site. Swelling and redness gradually subsided and completed resolved within 7 - 10 days. Y Y 01/08/2001 01/09/2001 1 PUB PUB NONE NONE PCN IA01003 1
0165558 02/02/2001 GA 54.0 53 F 01/25/2001 5-6 days post vax, the pt experienced severe pain and aching in left arm extending to fingers. Pt developed numbness of thumb and fore finger with tingling sensation. After 4 months, the pt still experiences numbness after almost 3 months of physical therapy. Pt is being treated with ????? and Vioxx daily and has used codeine for pain. Y N 09/29/2000 10/03/2000 4 PVT PVT St John's Wort; Klonopin; Premarin, Vitamin E mild depression; crick in the neck 1
0165559 02/02/2001 NJ 39.0 39 M 01/24/2001 Pt reported that the afternoon of receiving the vax, he felt achey and nauseated. He vomited several times that evening. One day post vax his fever rose to 101 - 102 degrees and he continued with achiness. Two days post vax he felt fine. Pt reported no local reaction at injection site. Y 12/28/2000 12/28/2000 0 PUB PUB NONE NONR chlorine and donnatol allergies NJ20012 1
0165560 02/02/2001 AZ 0.6 0 .5 F 01/12/2001 Subsequent to receiving vax, mom states that pt cried painful cry inconsolably for over 3 hours. Pt was given Tylenol prior to and every 4 hours without relief. No temperature taken however, mom states that pt was warm to the touch. Referred to PCP. Y 10/25/2000 10/25/2000 0 PUB PUB NONE AZ0103 1
0165682 02/02/2001 OH 51.0 51 M 01/23/2001 24 - 48 hours post vax the pt experienced nausea, headaches and body and joint aches; especially knees, elbows and hips. Left arm was red and swollen from elbow to shoulder with warmth in general area. Pt also felt general malaise. Attending physician felt pt may have sterile abscess. Pt treated with Tylenol and applied cold compress to left arm. Pt did not have a fever at the time of examination. Follow up information received from a CNP stated that the pts symptoms had completely resolved within one week of onset. No prescription drugs were used. Y 08/29/2000 08/31/2000 2 NONE PVT OTH Allegra; Zocor; Zoloft; Nasonex high cholesterol; depression; hyperparathyroid seasonal allergic rhinitis QC0031 1
0165684 02/02/2001 MA 21.0 20 F 02/02/2000 Pt states her eye became red, swollen and itchy the next morning after receiving the vax. She returned to the Board of Health two days post vax and her eyes were still red and itchy. Y Y 01/31/2000 02/01/2000 1 PUB PUB NONE NONE NONE MA0008 1
0165685 02/02/2001 MA 20.0 20 F 02/11/2000 One day post vax, the pt awoke with pain in her left deltoid area accompanied by redness and swelling, fever, and numbness of entire left arm. Y 02/09/2000 02/10/2000 1 PUB PUB NONE NONE NONE pain in arm~Tetanus Toxoid (no brand name)~~17.00~In Patient MA0009 1
0165687 02/02/2001 PA M 01/18/2001 Subsequent to receiving the third dose of Lymerix, the pt experienced injection site soreness. As of 09/27/2000, the outcome is unknown. U OTH OTH 20000300991 1
0165688 02/02/2001 CT M 01/18/2001 Subsequent to receiving first and second doses of Lymerix, the pt tested positive for Lyme disease. The pt had no symptoms. As of 10/02/2000, the outcome of the event is ongoing. N 08/20/2000 Lyme disease - negative (06/19/2000); Lyme disease - positive (10/02/2000) OTH OTH The pt reported a tick bite in June of 2000. 20000301051 1
0165689 02/02/2001 NY 31.0 F 01/18/2001 Approximately 3-4 hours post vax the pt felt warm and flush to the point of passing out, was nauseous and vomited (or almost vomited). As of 10/13/2000, the outcome of the events is unknown. U OTH OTH 20000307091 1
0165690 02/02/2001 PA 43.0 M 01/18/2001 Subsequent to receiving one dose of Lymerix, the pt was achy for 3-4 days. This event resolved. Subsequent to receiving the second dose of Lymerix, the pt was achy for 48 hours. This adverse event resolved. Subsequent to receiving the third dose of Lymerix, the pt experienced edema and ache in his upper left arm. This adverse event resolved. No treatment was given. As of 10/16/2000, the outcome of the events is resolved. Y PVT PVT acid stomach medication (NOS); high blood pressure medication (NOS) acid stomach; high blood pressure 20000308961 1
0165691 02/02/2001 NJ 43.0 F 01/18/2001 Subsequent to receiving the second dose of Lymerix the pt experienced bad reactions whenever she received a bug bite. The bite broke out and scabbed up leaving scars. A doctor visit was required and the pt was treated with lindane which didn't really help. As of 10/20/2000 the outcome of the event is ongoing. Y N 07/14/2000 OTH OTH allergic to PCN 2000309171 1
0165692 02/02/2001 IL U 01/18/2001 Subsequent to receiving vax, the pt developed arthralgias and arthritis. As of 10/26/2000, the outcome of the events is unknown. U OTH OTH 20000315311 1
0165693 02/02/2001 45.0 F 01/18/2001 On an unspecified date, the pt received a dose of Lymerix which did not go into arm. On 4/5/99 at 11:30 the pt received her third dose. 90 minutes later, she experienced severe chills, body aches, fever, fatigue and malaise. The pt went to bed. As of 9/25/00, the outcome of the events is unresolved. N 04/05/1999 04/05/1999 0 PVT OTH 20000315501 1
0165694 02/02/2001 MD 51.0 47 F 07/19/2001 Subsequent to receiving unspecified doses of Lymerix or placebo, the pt was bitten by a tick. The bite left a red mark at the site of the bite. As of 10/27/2000, the outcome of the event is unknown. U 03/25/1996 10/26/2000 1676 PUB PVT Migraine headaches 20000318921 1
0165695 02/02/2001 PA 60.0 M 01/18/2001 Subsequent to receiving the third dose of Lymerix, the pt experienced symptoms of gastroesophagal reflux disease. These did not cause hospitalization or disability. The reporter considered the event to be probably unrelated to Lymerix, and attributed the temporal relationship to coincidence. As of 11/17/2000, the outcome is ongoing. N OTH OTH 20000323041 1
0165696 02/02/2001 NY 34.0 M 01/18/2001 Subsequent to receiving one dose of Lymerix, the pt was achy all over. The outcome is ongoing. Subsequent to receiving the second dose of Lymerix, the pt continued to feel achy all over. No treatment was given. The physician plans to administer the third Lymerix dose in November, 2000. The physician stated that he was not sure if the adverse event is related to Lymerix, due to the pts complaint of achiness prior to the first Lymerix dose given. As of 11/02/2000, the outcome of the event is ongoing. N 11/30/1999 PVT PVT Vasotec Pt has hypertension and had the achiness prior to receiving the first dose of Lymerix. 20000323101 1
0165697 02/02/2001 PA 49.0 M 07/19/2001 Subsequent to receiving second dose of Lymerix, the pt experienced tendinitis in the right arm. As of 11/01/2000, the outcome of the event was not completely resolved; the right arm flared with use. Subsequent to receiving the third dose of Lymerix, the pt experienced tendinitis in his elbows. No treatment was given. The reporting physician stated that the tendinitis was moderate in intensity and possibly related to Lymerix. He stated that the tendinitis could be associated with the pts occupation of landscaper. As of 12/13/2000, the outcome of the event is unknown. N 06/15/2000 PVT PVT acetysalicyclic acid allergy injections 20000323161 1
0165698 02/02/2001 37.0 37 F 10/09/2001 On 09/28/2000 the pt received one dose of Lymerix. On 10/12/2000 the pt had a positive pregnancy test. The pts last menstrual period was 09/07/2000; the estimated delivery date is 06/14/2001. Follow up states that the vaccinee had four previous pregnancies resulting in normal births. On 06/20/2001, at 40 weeks gestational age, the vaccinee delivered a male infant by spontaneous vaginal delivery. Birth weight was eight pounds and nine ounces. Neonatal status was recorded as "normal." His apgar scores were 8/10at one minute and 9/10 at five minutes. Mother and infant experienced "no complications" and "no problems." Y 09/28/2000 10/12/2000 14 Positive pregnancy test 10/12/2000 OTH OTH NONE NONE 20000330651 1
0165699 02/02/2001 16.0 M 07/20/2001 Four months subsequent to receiving the third dose of Lymerix, the pt presented with monoarticular knee synovitis. His serology at the time revealed antibodies to 93, 66, 41, 31, 30, 28 and 21 kDa antigens on IgG and 93 and 41 on IgM. The authors stated that since it was difficult for clinicians to differentiate either between either vaccine induced arthritis or Lyme arthritis in a pt, the pt was treated with a full course of doxycycline therapy. Four months later the pt was asymptomatic. It was commented by the authors that this was likely a delayed vax induced arthritis. The events of the knee synovitis and arthritis do not meet ICH serious criteria, but are being submitted as an expedite report by special FDA request. Y Y Serology revealed antibodies to 93, 66, 41, 31, 30, 28 and 21 kDa antigens on IgG and 93 and 41 on IgM. PVT PVT Lyme disease 20000339071 1
0165700 02/02/2001 10.0 M 07/10/2001 One month post vax the pt developed bilateral knee synovitis. Over the five ensuing months, the pt developed intermittent asymmetrical oligoarthritis of his knees, ankles, elbows and proximal interphalangeal joints at roughly monthly intervals. His serum five months post vax revealed antibodies to 93, 69, 66, 64, 54, 53, 41, 29, 31, 30, 28, 26, 25, 22 and 21 kDa antigens and none on IgM. He was also noted to carry HLA-DR4. The authors stated that since it was difficult for clinicians to differentiate between either vax induced arthritis or Lyme arthritis in a pt, the pt was treated with antibiotics. Two months later the pt was asymptomatic. It was commented by the authors that this was likely a case of delayed vax induced arthritis, although the extent of immune response suggests either current or past B, burgdorferi exposure with disease reactivation induced by the vax. The events of the knee synovitis and oligoarthritis do not meet ICH serious criteria but are being submitted as an expedite report by special FDA request. Y Y Serum five months post vax revealed antibodies to 93, 69, 66, 64, 54, 53, 41, 39, 31, 30, 28, 26, 25, 22, and 21 kDa antigens and none on IgM. He was also noted to carry HLA-DR4. PVT PVT 20000339221 1
0165701 02/02/2001 U 01/18/2001 At the time of dermatology consult the pt reported recent immunization with Lymerix. At some time later, the pt developed redness at the injection site. N OTH OTH 20000339401 1
0165702 02/02/2001 VA 31.0 F 01/18/2001 In August, 2000 and October, 2000, the pt received first and second doses of Lymerix. The pt recently discovered that she was pregnant. The date of the last menstrual period was 10/24/2000 and the estimated delivery date is 08/01/2001. As of 11/27/2000, the outcome of the pregnancy is ongoing. N OTH OTH 20000343311 1
0165703 02/02/2001 NJ 31.0 F 10/09/2001 On 11/21/2000 the pt received the first dose of Lymerix. Subsequently she was found to be pregnant. The date of her last menstrual period was 10/21/2000, the date of the positive pregnancy test was 11/28/2000 and the estimated delivery date is 07/30/2001. As of 11/30/2000 the outcome of the pregnancy is ongoing. The follow-up states that on 10/13/2000, the vaccinee had an appendectomy and a ruptured ovarian cyst. On 09/14/2001, the vaccine provider stated,"We have no reports on the outcome of her possible pregnancy." Y U 11/21/2000 11/28/2000 7 positive pregnancy test 11/28/2000 OTH OTH Appendectomy, ruptured ovarian cyst 20000347791 1
0165704 02/02/2001 KS 55.0 M 01/18/2001 Subsequent to receiving the third dose of Lymerix, the pt noticed soreness in the deltoid muscle (NOS). On follow-up the reporter stated that the pt did not experience a side effect from the Lymerix, but rather had a muscle condition that was not caused by the vax. As of 12/14/2000 the outcome of the event is unknown. U 06/30/2000 07/01/2000 1 PVT OTH 20000349141 1
0165705 02/02/2001 NJ 44.0 F 01/18/2001 Within 24 hours post vax, the pt experienced flu-like symptoms, soreness at the injection site and a fever. She did not seek medical attention. She recovered within 48 hours. Y OTH OTH 2000034928 1
0165706 02/02/2001 NJ 33.0 M 01/18/2001 Less than one hour post vax, the pt experienced dyspnea and chest pain which lasted three hours and then resolved. Lymerix was discontinued. An ECG taken on 07/06/2000 showed ST elevations (NR: none). A cardiac evaluation yielded no cardiac disease. The reporting physician stated that the event could be associated with the pts anxiety disorder. As of 12/12/2000 the outcome of the event is recovered without complications. Y 07/06/2000 07/06/2000 0 ECG ST Elevations (Normal Range : None) 07/06/2000 OTH OTH Paxil Anxiety disorder 20000358461 1
0165707 02/02/2001 55.0 M 01/18/2001 Case logically deleted; no indication in records provided that an SB product was administered. Y U OTH OTH 20000366801 1
0165561 02/05/2001 MA 43.0 43 F 01/21/2001 After having 2 injections of Lymerix vaccine, I have developed chronic joint pain. Is this the autoimmune associated arthritis theorized to be caused by the Lymerix vaccine? This joint pain has been unresponsive to physical therapy, cortisone injections, and NSAID's. Y Y 05/03/1999 I have had negative X-rays, MRI's and a Bone Scan. UNK UNK Migraines; s/p dysmenorrhea 1
0165562 02/05/2001 NY 1.08 1 .1 F 01/24/2001 Pt developed regression. Child was developing normally. Started talking and could even sing Happy Birthday and a made up song using her middle name. She sang everybody loves me. The regression was gradual until she lost all language and comprehension ability and all social behavior. Y N 11/07/1995 12/01/1995 24 Measles antibody titer tests are very high. 2nd MMR not given. On 7/27/00-191.0 iu/ml and on 9/20/99-450 units PVT OTH Multivitamin supplement NONE Occasional ear infection; he has a twin brother 1
0165579 02/05/2001 FL 2.0 1 1 F 01/26/2001 It was reported that a female pt received a Fluzone SV '00-'01 vaccination on 12/28/00. Reportedly, on 1/20/01, the pt was admitted to the hospital with the dx of respiratory distress. The pt spent 3 days in MICU. The pt's mother states that the pt is in "fragile" health so does not go out. Pt's mother and her husband have not had the flu and neither have the nurses who visit the pt. The pt's physician feels it was the vaccine which caused this. The pt is still having some respiratory problems but is getting back to baseline. Y N 12/28/2000 01/20/2001 23 UNK UNK Synagis U2001002410 1
0165580 02/05/2001 49.0 M 01/31/2001 The same day as vax, on 5/19/99, the pt became dizzy and developed a fever, nausea, and headache. He recovered within 24 hours without treatment, The pt received his second injection of Lymerix on 6/17/99 he had no adverse experience following this injection. The pt received his third injection on 5/11/00. The next day on 5/12/00 the pt became tired and experienced pain at the injection site. The injection site pain resolved. The pt was still tired as of 1/30/01. N 05/19/1999 05/19/1999 0 OTH OTH Prilosec, Synthroid acid reflux, allergy to PCN, colitis, hyperthyroidism 20010025311 1
0165581 02/05/2001 PA F 02/01/2001 On an unspecified date, the pt received her third dose of Lymerix. Subsequently, the pt experienced arthritis versus arthralgia, reportedly. As of 1/31/01 the outcome of the event is unknown. U OTH OTH 20010026231 1
0165582 02/05/2001 WV 68.0 68 F 01/23/2001 The morning after the vax, the pt complained of dizziness with a fever of 101.5 and chills. Fatigue, loss of appetite, body aches all over. The pt remained in bed for 2-3 days, drank fluids and took Tylenol. The area is approximately 2-3 inches in diameter with redness and induration on the right deltoid area. The arm is red hot to the touch and sore. The pt has experienced lingering fatigue. U 01/16/2001 01/17/2001 1 PUB PUB Synthroid, amitriptylline, Vaycol, hydrocodone NONE Fibromyalgia, irritable bowel syndrome, thyroid disease, high cholesterol WV0103 1
0165583 02/05/2001 NE 56.0 56 M 11/30/2000 The pt experienced a fever on the night of administration. Over the next several days, the left arm swelled to twice the size of the right arm. Mild cellulitis was noted at the next visit. Treated with Keflex. Y U 11/13/2000 11/13/2000 0 UNK UNK Uniphyl, aspirin, Flovent, Combivent 1
0165584 02/05/2001 NJ 56.0 55 M 01/02/2001 Pt states that subsequent to receiving first vax (03/22/2000), he experienced soreness at the injection site for 1-2 days. Approximately one month post vax, (04/28/2000), he experienced soreness at the injection for 1 day. On 11/17/2000 pt had no complaints. On 12/02/2000 pt did not have a reaction but complained of soreness at the site of the first immunization. Area red and the size of a dime accompanied by pruritus. Y 03/22/2000 NONE PUB PUB Prevacid; Zocor; Zestril Heart condition; heart attack at age 41 NJ20013 1
0165773 02/05/2001 OR F 01/02/2001 A pharmacist reported that a female received an injection on Influenza virus vaccine (manufacturer unknown) and subsequently experienced an anaphylactic reaction. The reporter did note that this information was "questionable" and there is no documentation of the reported event. Anaphylactic reaction is considered medically important. U UNK OTH OTH UNK UNK UNK HQ4464605DEC2000 1
0165774 02/05/2001 OH 53.0 53 F 12/21/2000 Seven days post vax, the pt developed an injection site reaction characterized by a welt with itching and pain. The pt recovered. Y 10/14/1999 10/21/1999 7 UNK PVT OTH calcium; Celebrex; Claritin; Cleocin T; Entex LA; Evista; Flonase; folic acid; Omega-3 triglycerides; Synthroid; Vitamin B-12; vitamins, other combinations NONE UNK HQ2984031OCT2000 1
0165775 02/05/2001 MD F 12/21/2000 Subsequent to receiving vax, the pt developed a 4 X 8 cm wheal. She recovered. Y UNK PVT OTH Prilosec NONE Gastro-oesophageal reflux disease HQ4336601DEC2000 1
0165776 02/05/2001 KS F 12/28/2000 Subsequent to receiving vax, the pt developed a severe nosebleed. The pt recovered. Y 11/01/1999 11/01/1999 0 UNK PUB OTH UNK UNK UNK HQ4336801DEC2000 1
0165777 02/05/2001 MI 44.0 43 F 12/22/2000 Subsequent to receiving vax, the pt experienced bloodshot eyes. Follow up information was received 01/29/2001 from the original reporting nurse that indicated that the patient received Flu Shield (2000-2001 Formula) on an unspecified date. No adverse events or bloodshot eyes resulted. U 01/01/1999 UNK OTH OTH UNK NONE UNK HQ4640208DEC2000 1
0165778 02/05/2001 NH U 01/22/2001 Subsequent to receiving vax, the pt developed flu-like symptoms. No further information was available at the date of this report. Manufacturer's Comment: The reporter indicated that 39 pts experienced this event; however, they are not presently identifiable. Additional reports will be generated when identifying information is provided. U UNK OTH OTH UNK UNK UNK HQ4922215DEC2000 1
0165779 02/05/2001 KY 10.0 F 12/21/2000 Subsequent to receiving vax, the pt developed a low-grade fever (less than 100 degrees F) and general aching that persisted for one day. Y body temperature <100 degrees F OTH OTH UNK UNK UNK HQ4940515DEC2000 1
0165780 02/05/2001 KY 9.0 F 12/22/2000 Subsequent to receiving vax, the pt developed a low grade fever (less than 100 degrees F) and general aching that persisted for one day. Y UNK OTH OTH UNK UNK UNK HQ5048319DEC2000 1
0165781 02/05/2001 KY 8.0 F 12/21/2000 Subsequent to receiving vax, the pt developed a low grade fever (less than 100 degrees F) and general aching that persisted for one day. Y UNK OTH OTH UNK UNK UNK HQ5048419DEC2000 1
0165782 02/05/2001 KY 7.0 F 12/21/2000 Subsequent to receiving vax, the pt developed a low grade fever (less than 100 degrees F) and general aching that persisted for one day. Y UNK OTH OTH UNK UNK UNK HQ5048519DEC2000 1
0165783 02/05/2001 NH U 01/22/2001 Subsequent to receiving vax, the pt developed flu like symptoms. No further information was available at the date of this report. Manufacturer's Comment: The reporter indicated that 31 employees experienced this event; however, they are not presently identifiable. Additional reports will be generated when identifying information is provided. U UNK OTH OTH UNK UNK UNK HQ5954216JAN2001 1
0165784 02/05/2001 NC 54.0 F 12/22/2000 Pt reported that subsequent to receiving vax, she developed Bell's Palsy. No further information was available at the date of this report. U UNK OTH OTH Glucophage; Hydrochlorothiazide UNK UNK HQ3812116NOV2000 1
0165785 02/05/2001 PA F 12/22/2000 Subsequent to receiving vax, the pt developed a severe local injection site reaction. U UNK OTH OTH UNK UNK UNK HQ4336401DEC2000 1
0165786 02/05/2001 MI F 12/22/2000 Subsequent to receiving vax, the pt developed an injection site reaction characterized by severe pain and swelling. As of 12/13/2000, the pts arm remained tender. No further information was available at the date of this report. U UNK OTH OTH UNK UNK UNK HQ4858814DEC2000 1
0165569 02/06/2001 CA 74.0 74 M 01/18/2001 One day post vax the pt had a sore arm and some slight bruising. The aching increased up into his neck with a bad headache, and eventually to both shoulders and down the other arm. By the next day his pain was so severe, his wife drove him to the ER. FU: pt passed away at home. Cause of death: myeloid leukemia and ASHD. Y Y Y Y 8 N 11/08/2000 11/09/2000 1 Blood work, Urine test, Bone Marrow PUB PUB Tylenol #3, Atrovent Inhaler, Valium, Altace, Pravachol/Azmacort Bronchitis, asthma, back and heart surgery history with back surgery 2 months previously and hayfever. Myeloid leukemia, ASHD. CA000163 1
0165571 02/06/2001 NC 0.8 0 .9 F 01/24/2001 The pt had a generalized tonic/clonic seizure at home and then went to the ER. Then she had a second seizure in the ER. Y Y 2 Y 01/22/2001 01/22/2001 0 blood culture, CBC, Chem 7, Lumbar puncture, EEG, CT head PVT PUB NONE NONE NONE NC00007 1
0165572 02/06/2001 TX 33.0 33 M 02/01/2001 The pt went into respiratory arrest within minutes of receiving a tetanus toxoid injection. Y Y 10/24/2000 10/24/2000 0 OTH OTH Open wound allergy to PCN 1
0165574 02/06/2001 WA 0.16 0 .2 F 02/01/2001 It was reported that a 2-month-old female receivred an injection of IPOl on 01/08/2001. Reportedly the patient developed tachycardia within seveh hours post-immunization. She was taken to the emergency room and hospitalized for observation the patient recoverred and was discharged. FOLLOW-Up correspondence received on 02/27/2001, per the responsible physician, this adverse event should be classified as lethargy not tachycardia as previuously reported. From additional information received from the manufacturerof the DTaP vaccine which the patient received. Medical history included premature birth at 35 weeks gestation.There were no concomitant medications and no illness at the time of immunization. The infant recived her first injection of Infanrix on 01/08/2001. She also recived injections of inactivasted poliomyelitis virus vaccine (IPOL), hepatitis b vaccine (recombivax HB) and Haemophilus influenzae type b vaccine (brand name unknown)on 01/08/2001. Within seven hours post-immunization, the infant developed tachycardia and lethargy. She was taken to the local emergency room and hospitalized on 01/09/2001 to rule out sepsis. Labs work ruled out sepsis. The infant recovered on 01/11/2001. Without treatment, and was discharged. The most recent information, received 02/22/2001, indicated that the infant remained recovered. FOLLOW-UP correspondence received from the manufacturer of the Hepatitis b vaccine which the patient received. " Information has been received from a health care progfessional concerning a 57 day old Hispanic female with no known allergies, who was frankbreech and delivered prematurely (35 weeks) on 11/12/2000. The child was delivered by C-section due to pregnancy induced hypertension. She also had transient tachypnea of newborn for which she spent time in the neonatal intensive care unit On 01/08/2001, The patient was vaccianted intramuscularly in the LUL with a second dose of hepatitis b vaccine recombinant (yeast) (lot # 6342148/1739J). Concomitant therapy included a first dose intramuscularly in the RUL of poliovirus vaccine (IPOl)(lot #R1437), a first dose intramuscularly in the RUL of diptheria toxoid (+) Hemophilus B conjugate vaccine (Prohibit)(lot # UA522AA) and a first dose of 0.5 ml intramuscularly in the RLL of diptheria toxoid/pertussis vaccine/teta (Infanrix) (lot #ILLEGIBLE). On 01/08/2001 at 6 pm the patient becanme difficult to waken and had taken a total of 5 oz of formula that day. She had 8 wet diapers. She had no fever at home for (?). Physicians notes revealed that the baby was listless but with good color. She cried with stimulation and took one ounce of formula in the office. Temperature was 100.4 on admission rectally,pulse 100, respirations 40. Her eyes were focusing and she went back to sleep when not stimulated. The patient was hospitalized for IV antibiotics and observation due to lethargy, tachycardia, fever, decreased appetite and difficulty to arouse. On 01/11/2001, the patient was recovered and was discharged to home. It was noted that the physician felt it was a probable neurotoxic reaction to acellular pertussis vaccine but was also ruling out an infection. Follow up on 12/16/2003: "From additional information received on 12/08/03 from Merck it was reported that this report was received from the manufacturer and was assigned manufacturer report # INF 2001001746-1. It was originally reported by a physician. No further information was reported." Y Y Y 01/08/2001 01/08/2001 0 Blood culture, urine cultures and CSF labs-WNL;Urinalysis-WNL;specificgravity-1.005; WBC-10.3; HBG-9.9; platelet-530,000; sodiump136; potassium-7.9 (hemolyted); chloride 105; BUN-10; creatinine-0.3; glucose-90; Spinal tap: test results within normal limits; Serum blood urea nitrogen: 10; Serum chloride: 105; Serum creatinine: 0.3; Serum glucose: 90; Serum potassium: hemolyzed specimen; Serum sodium: 135; Urine specific gravity: 1.005; Temperature measurement: 100.4; WBC count: 10.3; Hemoglobin: 9.9; Platelet count: 530,000; Urinalysis: normal; UNK UNK U200100319 1
0165575 02/06/2001 OH 20.0 M 02/01/2001 The pt developed numbness from the shoulder to the knees. Was admitted to the hospital for observation for several days. Y U 12/23/2000 UNK UNK U2001002810 1
0165576 02/06/2001 WA 1.3 1 .3 M 01/29/2001 Pt had full left thigh swelling, redness, induration and warmth at 48-72 hours, post vax. He was admitted to the hospital X 24 hours for IV antibiotics in case it was cellulitis. Y 1 Y 01/19/2001 01/22/2001 3 Afebrile, Blood CX-neg, CBC-nml PVT PUB NONE NONE 1
0165577 02/06/2001 NC 0.75 0 .8 M 01/24/2001 At 07:00 on 1/18/01, pt started vomiting and seemed dizzy. Seen MD at 08:30 with disorientation and nystagmus. Sent via EMS to medical center. Dx'd with acute cerebral ataxia. Was discharged on 1/19/01.F/U altered LOC ,refusing to stand,IV started, blood drawn. Pt vomiting, dizzy, reaction to Prevanar. Pt was admitted for observation. Y Y 1 Y 01/17/2001 01/18/2001 1 urine and drug screen - neg PVT UNK URI, yeast diaper dermatitis NC00010 1
0165578 02/06/2001 CA 1.2 1 .2 M 01/26/2001 The pt developed respiratory distress, wheezing, urticaria on the same day as vax. Skin color was red and skin was warm. Treated with epinephrine. Transferred to ER for observation and possible admission. Y Y Y 01/26/2001 01/26/2001 0 02 saturation PVT PUB NONE NONE V/P Shunt; Hydrocephalus; Right lung disorder; Tracheomalacia 1
0165586 02/06/2001 22.0 F 01/17/2001 Given Rubella and Flu vaccine and 1/2 hour, post vax, had a headache and itching which continued into facial swelling, chest tightness and wheezing. Returned to UHS with symptoms and was given epinephrine and Benadryl IM and sent to ER. Y Y Y 01/05/2001 01/05/2001 0 UNK UNK allergy to PCN, Iodine, shellfish 1
0165587 02/06/2001 CA 0.4 0 .3 M 01/28/2001 The night of the vaccination, the pt experienced blood in urine, unexplained hives and rash including red dots on palms of hands, severe ear infection, fussiness, rash around mouth and diaper area. Usually is an extremely happy baby. Y Y 12/19/2000 12/19/2000 0 PVT OTH NONE NONE eczema 1
0165588 02/06/2001 FL 1.0 1 .0 F 02/02/2001 Within 15 seconds of 2nd vaccine the pt developed bradycardia, cyanosis, and rigid apnea, head turned right. Pt given stimulation for apnea and O2 and pulse ox monitoring. Pt regained normal state approximately 5-10 minutes later. Entire episode lasted 2-3 minutes. Y 02/01/2001 02/02/2001 1 pulse ox - 99% PVT PUB NONE NONE 1
0165589 02/06/2001 IN 0.75 0 .8 M 01/29/2001 Within 3 hours of vax, the pt developed irritability, low grade fever up to 100.8, rhinorrhea and cough. 2 days later he was diagnosed with otitis media and treated with Amoxicillin. Y Y 01/24/2001 01/24/2001 0 PUB PUB NONE NONE 1
0165590 02/06/2001 MO 1.0 1 .0 M 01/30/2001 Eight days post vax, pts parent noted 2-3 small red bumps on abdomen. The next day the sitter call parent saying the pt had red bumps on the face and abdomen. U 01/22/2001 01/30/2001 8 PVT PVT NONE NONE NONE 1
0165591 02/06/2001 NC 1.0 1 .0 M 01/30/2001 3-4 hours post vax, pt awakened from nap with entire trunk and legs very red. Pt was treated with Benadryl and within 2 hours redness was gone. No swelling, fever of trouble breathing was noted. Y 01/22/2001 01/22/2001 0 PVT OTH NONE NONE NONE 1
0165592 02/06/2001 MA 1.0 1 .0 F 02/02/2001 The pt developed a mild generalized varicella as well as local varicella rash at the injection site appearing 10 days post vax. Y 01/23/2001 02/02/2001 10 NONE PVT PUB NONE NONE NONE 1
0165593 02/06/2001 MI 0.7 0 .7 F 01/22/2001 Mom first reported AE on 1/18/01. Evening of vax, pt developed a dozed look had been crying alot, had been limp, no longer able to sit up by herself, eyes frequently rolled back mother reports these symptoms occurred five times a day for approximately 1 min at a time for the 1st week after vax, symptoms were slowing down 1/18 on 1/19 all was normal. Y 01/08/2001 01/08/2001 0 PUB PUB NONE 2 days prior to vax but 2 weeks previous had fever, diarrhea, coughing MI2001009 1
0165594 02/06/2001 TX 30.0 28 M 01/20/2001 Feb 19 1999 onset of lump in left deltoid Feb 20, 1999. N 02/19/1999 02/20/1999 1 UNK UNK NONE 1
0165595 02/06/2001 OH 28.0 28 F 01/17/2001 Within 30 minutes my left arm had shooting pain down to my pinky and ring finger (which went numb for several hours) and though my left shoulder. I still have a large lump and alot of pain in my shoulder and upper arm. Y 01/15/2001 01/15/2001 0 OTH OTH NONE NONE NONE 1
0165596 02/06/2001 IL 81.0 81 F 12/05/2000 Within 3-5 minutes after receiving the flu vac pt started swaying legs at arms back and fourth in a spastic movement - appeared to happen more with the right leg left arm. Pt was staring down an did not report to verbal question. No hx of seizures or hearing problems pt did not remember anything that occurred. Lasted about 10 seconds Y 12/04/2000 12/04/2000 0 EEG to be done on 12/6/2000 as follow up to incidence PVT PVT NO NO IL00073 1
0165597 02/06/2001 MN 36.0 36 F 01/24/2001 Less than 12 hours started cold/flu signs & symptoms runny nose, sore throat, cough. Less than 48 hours was in ER due to difficulty breathing. Have been ill on and off ever since (stomach flu, colds) Y Y 11/15/2000 11/17/2000 2 PUB OTH Prozac, Pulmicox 1
0165598 02/06/2001 MI 53.0 53 M 01/08/2001 Injection 11:30 -6pm soreness of arm, redness and swelling of arm from elbow to shoulder 36 hours started up inner arm into axillary. Chills, fever, lost of appetite, nausea. U 01/05/2001 01/05/2001 0 PUB UNK NONE NONE NONE MI2001004 1
0165599 02/06/2001 MI 54.0 54 F 01/08/2001 24 hours after injection - fatigue, generalized achiness, arm was red, swollen & painful. Fever, headache, chills, redness size of grapefruit, loss of appetite. Y 01/05/2001 01/06/2001 1 PUB UNK Prempro NONE MI2001005 1
0165600 02/06/2001 MI 65.0 65 M 01/08/2001 Left arm swelling B/W elbow and wrist 2 x normal size. Red/warm to touch. Uncomfortable, painful to touch. Family provider seen on 1/4/01. Dx reaction to immunization, question pneumonia vaccine and or tx. Resolved by 1/8/01. Y Y 12/28/2000 12/28/2000 0 PUB UNK NONE NONE NONE MI2001006 1
0165601 02/06/2001 MI 38.0 38 M 01/12/2001 Generalized redness in 24 hours. Friday 1/5/01 upper arm red and very painful. Today began to subside. Y 01/03/2001 01/04/2001 1 NONE PUB PVT MI2001007 1
0165602 02/06/2001 MI 48.0 48 M 01/12/2001 1/4 nausea and GI, 1/5 stiff neck, chest pain, swollen lymph groin, 1/6 achy, more chest pain, 1/8 severe chest pain with pleurisy. MD said maybe pneumonia vax. Y 01/03/2001 01/04/2001 1 PUB PVT MI2001008 1
0165603 02/06/2001 MO 47.0 47 F 01/23/2001 Immediately after receiving vaccine client c/o ringing in ears and lightheadedness. Had client lie down, elevated feet and used ammonia inhalant. BP consistent 94/46. Felt better in approx 10 minutes and BP 100/60 after walking around before release 1/18/2000. Client had no further problem. Y 01/21/2001 01/21/2001 0 NONE PUB PUB NONE NONE Hx of fainting or nearly fainting after shots esp. in Doctors office. MO2001001 1
0165604 02/06/2001 VA 33.0 33 F 01/17/2001 Approximately 12 hours post vax area around puncture site became swollen, warm and red. Used warm compresses. Still a problem next morning. Exam done by MD 24 hours post injection. Dx as local reaction to vax. Arm did not improve and patient saw private MD, dx cellulitis placed on Amoxicillin. 1/11/01 Arm improved. Pt incidentally developed pneumonia in both lungs and pancreatitis in the early post vax period. Y Y 01/09/2001 01/09/2001 0 PUB PUB Hep C, S/P splenectomy following MVA 9/2000. VA01005 1
0165605 02/06/2001 NC 33.0 33 F 01/23/2001 The pt states she awoke with pain in her left axilla, left arm and left inguinal groin area. States the left arm feels numb, tingly, and swollen. It was hard to put through ROM. wonders if related to injection on left side on 1/22. U 01/22/2001 01/23/2001 1 PUB UNK PPD NONE allergy to Amoxicillin NC00008 1
0165606 02/06/2001 NC 2.0 2 .1 F 01/10/2001 Pt had a reaction from her shot. Mom stated that post she dropped pt off at Daycare. The Daycare worker call her back because c/o head hurting turned blue around lips then pt went limp. It fell out of chair daycare worker caught her lowered her to the floor pt did not fully loose consciousness but she would not respond verbally or to stimuli. By the time mom got back to daycare she came back started speaking the episode lasted for 20 minutes mom immediately took her to doctor. He could not explain to mom what happen to patient. It could be possibly a reaction from the vax or something else. Mom wanted me to be aware of the episode because the literature I gave her said that a rare reaction like this one could occur. Y Y 01/10/2001 01/10/2001 0 PUB UNK NONE NONE NC00009 1
0165607 02/06/2001 MD 49.0 49 F 01/25/2001 Left arm pain and swelling apporx. 8 hours after injection. Y 01/19/2001 01/19/2001 0 PVT PUB COPD NONE MD01003 1
0165608 02/06/2001 MD 37.0 37 F 01/22/2001 The pt experienced pain, erythema, chills, fever with axillary pain and tenderness at the lymph nodes and swelling at the site. U 01/17/2001 01/18/2001 1 NONE PVT PVT Synthroid, Prevacid NONE allergy to codeine MD01002 1
0165609 02/06/2001 OR 37.0 37 F 11/28/2000 Same day as vax the pt experienced pain which lasted through day 4. On day 4 the pt experienced a 1-2 inch red skin with nodule or abscess deep in the tissue. Day 7-11 the pt's symptoms are resolving. No fever was noted. Y 11/17/2000 11/17/2000 0 PUB PUB burn left hand (reason for vax) OR200044 1
0165610 02/06/2001 FL 0.2 0 .2 M 01/26/2001 Subsequent to receiving vax, pt experienced crying, irritability and loss of appetite from evening of vax which lasted three days. Pt seen in ER on 01/25/2001 for persistent screaming and loss of appetite. Seen in office 01/26/2001 for irritability. Y Y 01/23/2001 01/23/2001 0 NONE PVT PUB Tylenol; Nystatin oral thrush NONE 1
0165611 02/06/2001 KY 33.0 33 F 01/29/2001 On 1/23/01 the pt experienced redness and burning. The pt's whole arm hurt. The next day, large red whelp and hardness, but was still red. Two days later the whelp is beginning to resolve. Y Y 01/23/2001 01/23/2001 0 PUB PVT Zyrtec, ibuprofen, Vanconase spider bite and sinus infection allergy to sulfa and Augmentin 1
0165612 02/06/2001 TX 4.0 4 F 02/01/2001 Pt experienced local redness and irritation at injection site. Y 01/24/2001 01/26/2001 2 PVT PVT NONE 1
0165613 02/06/2001 MO 5.0 5 F 01/25/2001 21 days post vax, the pt was brushing teeth and fell into mothers arms and began having seizure like activity. Ambulance called and delivered the pt to the ER. Mother concerned about link with immunizations. Mother reports Cat scan within normal limits. Scheduled to follow-up with primary MD on 01/29/2001. ER report shows pt discharged with febrile seizure activity and anemia and hematuria. Y Y 01/03/2001 01/24/2001 21 PUB OTH Dimetap on 01/23/2001 stuffy nose and congestion NONE MO2001003 1
0165614 02/06/2001 MO 4.0 4 F 01/26/2001 Subsequent to receiving vax pt experienced redness and swelling of arm. Pt was seen in the office 01/26/2001, with left deltoid injection site red, warm to touch and skin taut. Instructed to go to family doctor. Parent states that arm was not as red as it was the previous day. A follow up report received 10/02/2002 adds: This was originally reported by a registered nurse. Upon follow-up, it was reported that no further info was known. No further info is expected. U 01/24/2001 01/26/2001 2 NONE PUB OTH NONE NONE NONE MO2001004 1
0165615 02/06/2001 CA 0.3 0 .4 F 02/01/2001 Parent states that pt was crying inconsolably for 4-5 hours on evening of vax and irritable for 1-2 days. Y 11/30/2000 NONE PVT UNK NONE NONE Newborn hyperbillrubinemia 1
0165616 02/06/2001 CA 1.0 1 .0 M 10/31/2000 Subsequent to receiving vax, the pt presented to clinic with varicella type rash and temperature of 100.4. Y 10/19/2000 10/30/2000 11 PUB PUB NONE sulfa 1
0165617 02/06/2001 CA 11.0 12 F 5 minutes post vax, pt felt tingling in right arm. School nurse checked and found redness at injection site. One day post vax, the pt complained of numbness 2 inches above right elbow to fingertips. Has full use of arm and hand. Y Y 01/11/2001 01/11/2001 0 NONE PUB PUB NONE NONE NONE 1
0165618 02/06/2001 OH 0.3 0 .4 M 01/25/2001 Pt experienced febrile seizure. Y Y 09/15/2000 09/16/2000 1 PVT UNK febrile seizure NONE 1
0165619 02/06/2001 NY 1.0 1 .0 M 01/25/2001 Pt experienced tremors on hands, feet and lips accompanied by fever of 104F. Y Y 01/09/2001 01/11/2001 2 PVT UNK 1
0165620 02/06/2001 NV 1.0 0 1 M 01/31/2001 Ptosis close upper lid only 40% open for 24 hrs. Y 01/29/2001 01/29/2001 0 PVT UNK NONE NV0102 1
0165621 02/06/2001 NH 3.0 3 F 02/01/2001 Approximately 4 hours post vax, the pt experienced an elevated temp, parent gave acetaminophen and the highest recorded temp was 101. The pt also experienced unconsolable crying. The pt was taken to the ER. Symptoms resolved on 1/26. Y Y 01/24/2001 01/24/2001 0 PVT PUB NH0103 1
0165622 02/06/2001 WV 0.6 0 .3 M 01/15/2001 The pt experienced an intermittent high pitched cry for one day post vax. Y 10/03/2000 10/03/2000 0 PVT PUB NONE cough NONE 1
0165623 02/06/2001 MN 33.0 33 M 01/25/2001 The pt experienced vagal symptoms, diaphoretic, syncope. No long term problem. The pt was "ill" and nauseous for 3 days post vax. Y Y 12/22/1999 12/22/1999 0 NONE PVT PVT NONE NONE NONE 1
0165624 02/06/2001 CA 2.0 2 .2 M 01/29/2001 The pt was seen in the ER on 1/28 and diagnosed with Bells Palsy. Y U 01/27/2001 01/28/2001 1 UNK PUB NONE NONE NONE 1
0165625 02/06/2001 MA 11.0 11 F 12/04/2000 Following vax, the pt became weak and was assisted to the floor. At 10:33 B/P was 142/88. At 10:35 B/P was 140/96 and P 80. The pt began feeling better. At 10:40 B/P was 136/92 and P 64. The pt experienced pain on the left side of head. Y 11/02/2000 11/02/2000 0 NONE PUB PUB NONE NONE allergy to Amoxicillin MA0101 1
0165626 02/06/2001 IL 4.0 1 .7 M 01/29/2001 On 1/9/01, the pt developed 20 or so lesions typical of chicken pox. These were not infected. Y 09/10/1998 01/09/2001 852 NONE PVT PUB NONE NONE NONE 1
0165627 02/06/2001 WI 15.0 15 F 01/19/2001 The pt experienced a fever of 102, headache, dizziness. Went to the ER and pt felt better 3 hours later. Y Y 01/18/2001 01/18/2001 0 PUB UNK NONE NONE NONE 1
0165628 02/06/2001 VA 2.2 2 .2 M 01/17/2001 Patient developed a localized reaction to #4 DTAP characterized by a 5cm x 5cm red, hot area on left thigh. Y Y 01/12/2001 01/13/2001 1 PVT PVT NONE 1
0165629 02/07/2001 LA 32.0 32 F 01/31/2001 Information has been received through the pregnancy registry from a physician concerning a 32 year old Asian female who on 11/20/00 was vaccinated with varicella virus vaccine live. Concomitant therapy included measles - mumps - rubella vaccine. She was pregnant at the time of vaccination. LMP was 10/23/2000. Expected date of delivery is 07/30/2001. On 12/23/2000 at 8 weeks from LMP the patient had an elective termination. Y N 11/20/2000 12/23/2000 33 OTH OTH Pregnancy (LMP-10/23/00) WAES00120662 1
0165630 02/07/2001 TN 0.2 0 .2 M 01/08/2001 Immunization was given on 12/12/2000; weight 11lbs 10ozs, temperature 97.0. The infant died of SIDS on 12//23/2000. Y 12/23/2000 N 12/12/2000 12/23/2000 11 PUB PUB NONE NONE NONE TN00052 1
0165631 02/07/2001 WI 0.9 0 .9 M 02/05/2001 Report 20010027841 describes acute viral myocarditis and diffuse brain swelling in an 11 month old male. This report was received from an attorney, and the attorney's "medical expert", and has not been verified by a physician or other health professional. The vaccinee and his family had no history of drug allergies or vaccine reactions. The vaccinee was healthy with no prior or current illness. He was taking no medications except for the vaccines listed below. On 04/05/1999, the vaccinee received vaccinations of IPV OPV, and Hib (reportedly non-Smithkline Beecham products) in addition to Infanrix. On 04/05/1999, the vaccinee received the unspecified dose of Infanrix. At an unspecified time thereafter, the vaccinee developed flu-like symptoms (nos). His symptoms worsened, and he was transported to the hospital on 04/11/1999. During transport, the vaccine "coded" and could not be resuscitated. He was pronounced dead on arrival at the hospital. An autopsy revealed acute myocarditis and diffuse brain swelling. Reportedly, post-mortem viral titers were "uninformative" (nos). The reporter indicated that he believed that the events were most likely related to the OPV / IPV vaccinations, and not to Infanrix. Cause of death given as acute viral myocarditis. Also, there was brain swelling. Y 04/11/1999 N 04/05/1999 Autopsy OTH OTH NONE NONE NONE 20010027841 1
0165632 02/07/2001 CA 86.0 86 F 02/01/2001 A telephone report was received from a pharmacist on 01/26/01, regarding adverse events possibly related to administration of Fluvirin. Approximately one month after receiving Fluvirin, an 86 year old female developed: muscle weakness in her legs, cerebral vasculitis (confirmed at lumbar puncture) psychotic behavior, and was confused and agitated. This patient has a history of: untreated Parkinson's disease, hypertension, non-malignant brain tumor, atrial fibrillation, and has had "2 breastectomies". She has recently been diagnosed with lumbar disc disease; the brain tumor has been further identified as an acoustic tumor. Attempts to gather additional data have been unsuccessful. Y U 12/01/2000 01/01/2001 31 Cerebrospinal fluid - cerebral vasculitis OTH OTH NONE Hypertension, atrial fibrillation, Parkinson's disease, Non-malignant brain tumor (acoustic tumor), lumbar disc disease, 2 Breastectomies. MPI2001000630 1
0165634 02/07/2001 KS 0.75 0 .8 F 12/22/2000 Mom states the next day, infant "lost control of head and had jelly limbs" and also red spots on lower left side and back. Mom held and infant "returned to normal". On 11/18/00, the same thing happened but also went into grand mal seizure. Was hospitalized on 11/18/00. On 11/19/00, had another seizure. Y 4 Y 11/14/2000 11/15/2000 1 Several tests were done PUB PUB NONE NONE NONE KS200031 1
0165636 02/07/2001 FL 24.0 F 02/02/2001 This patient was reported to have secondary transmission, dehydration, fetal growth retardation, fever, varicella, vomiting, herpes zoster, pneumonia, and a respiratory condition. Information has been received from a mother who had experienced secondary transmission of varicella after her 12 month old daughter was vaccinated with varicella virus vaccine live. Two weeks after the child developed chicken pox (WAES # 01011852), the mother also got chicken pox. At the time, approximately 02/24/00, it was noted that the mother was in her first trimester of pregnancy. The mother was admitted into the hospital by her infectious disease doctor to monitor the fetus. The mother was unable to keep food down, was very dehydrated, developed shingles, pneumonia, and a temperature of 105 F. The patient was in the hospital about two weeks. After being in the hospital, the fetus that she was carrying "wasn't really growing" and then started growing later. As of 01/19/2001, the baby that she was carrying was 4 months old and was just in the hospital with respiratory problems. the mother also stated that "the baby doesn't keep down food but is still gaining weight". The mother stated "that she would like to know if all of this is related to the (varicella virus vaccine live) her oldest daughter got". Follow up information from the child's pediatrician stated that she indicated that because both the mother and the child had developed chicken pox at the same time, she felt that they must have both been exposed to the same source of wild type varicella and that the child's chicken pox had been modified because of the vaccine. In July 2000, the vaccinee was seen in the pediatrician's office for an 18 month visit, however there was no mention of the mother having to be hospitalized, nor any mention of the other adverse experiences which the mother described herself as having. No further information is available. Y Y Y OTH OTH UNK Pregnancy (LMP-UNK) WAES01011841 1
0165637 02/07/2001 NJ 11.0 F 02/02/2001 This patient was reported to have pancreatitis, fatty liver, pharyngitis, and vomiting. Information has been received from Glaxo Smithkline regarding information previously reported by a physician and the patient's mother concerning an 11 year old female who on 12/04/97 was vaccinated with a dose of Hepatitis B vaccine recombinant (yeast) (lot # 622792 / 0312E). It was reported that the patient developed pharyngitis, and was seen by her physician on 01/10/98. The patient's mother reported that the patient was treated with Amoxicillin / Clavulanate. Subsequently, she developed vomiting and was seen in the emergency room on 01/14/98. She was hospitalized with a diagnosis of pancreatitis. After 2.5 weeks, she was transferred to a tertiary care center for placement of a central venous catheter and total parenteral nutrition. It was reported that the patient has been hospitalized due to pancreatitis several times since, most recently from 10/06/00 to 10/09/00. The patient's mother reported that the patient currently has a fatty liver. The patient's mother attributed to the development of pancreatitis to the administration of Hepatitis B vaccine recombinant (yeast0. No further information is available. Other reference number is EB2001000505-1. Y Y U 12/04/1997 01/01/1998 28 UNK UNK UNK UNK WAES01012180 1
0165641 02/07/2001 KY 1.25 1 .3 M 02/01/2001 Information has been received from a physician concerning a 15 month old male with a history of Hepatitis B vaccine recombinant (yeast) (MSD) vaccination and a Haemophilus B conjugate vaccine (MSD) vaccination who on 12/18/00 was vaccinated with Haemophilus B conjugate vaccine (+) Hepatitis vaccine recombinant (yeast) in his left thigh. Concomitant therapy included varicella virus live, in the right thigh. Subsequently a few hours later on 12/18/2000, the patient experienced superficial 3/4 cm clear fluid blister at the injection site on his left thigh and an erythema at the injection site on the right thigh. The physician suspects a super imposed Staph scalded-type localized infection. The patient was placed on therapy with Cephalaxin (Keflex) to cover for Staph and Strep cellulitis. The source of admininstration was contacted and an internal investigation did not reveal any other cases. On 01/16/00, the patient was seen at the office for a "routine cold" that included a stuffy nose, and fever, subsequently the patient recovered. Upon internal review, Staph scalded-type localized infection was determined to be an other medical event. Additional information is not expected. Y Y 12/18/2000 12/18/2000 0 PUB PUB Hepatitis prophylaxis; vaccination WAES00121617 1
0165642 02/07/2001 KS 50.0 50 F 02/01/2001 An RN reported that, post vax, the 50 year-old Caucasian female with lymphoma and a history of cancer (type unspecified), chemotheraoy which ended in mid-September 2000. Upper extremity edema after receiving a tetanus injection and steroid therapy (prednisone) which stopped the last week of September 2000, who on 11/16/2000 was vaccinated with pneumococcal vaccine 23 polyvalent. (Lot 3 6945K invalid) intramuscularly in the left deltoid. Concomitant vaccination on 11/16/2000 included influenza virus vaccine (E64710HA) intramuscularly in the right deltoid. The pt experienced intermittent symptoms of achy left arm and pain that radiated down the left arm. The pt told the RN that once "the arm ached so bad that it made her sick to her stomach". She also reported that the outer aspect of the elbow was sore to the touch but the pt stated that "the elbow is better now". The pt told the RN that she had a lump under her left arm "that comes and goes". The RN reported that the pt thinks the lump under her arm "had to do with her lymph system". Unspecified medical attention was sought. In follow-up, the RN reported that on 11/16/00, shortly after receiving pneumococcal vaccine 23 polyvalent, the pt's left arm became sore and radiated downward toward the hand. She reported that a month later, the outer aspect of the elbow was sore to the touch, "which comes and goes". She reported that the pt had enlarged lymph nodes which ached to the point of causing nausea, which she states "occurs on and off". She stated that the pt's arm swelled when touched. The RN reported that the outcome of the pt's experiences were unknown. The sore arm, elbow sore to touch, enlarged lymph nodes, nausea and arm swelling were determined to be an "Other Important Medical Event. F/U In follow up the registered nurse reported that the pt was seen by her private family physician and the pt was treated with antibiotics. The symptoms persisted. The pt was sent back to her oconlogist. Lymphoma had reoccurred. The pt has since undergone a bone marrow transplant. The worsening lymphoma required hospitalization and was considered life threatening. The sore arm, elbow sore to touch, enlarged lymph nodes, nausea and arm swelling were determined to be an other important medical event. In FOLLOW-UP, the registered nurse reported that the patient had returned to teaching and was doing well as the time of the current report. She reported that the patient had a bone marrow implant in the summer of 2001 and had recovered from her experience No further information is available. Y U 11/16/2000 11/16/2000 0 UNK UNK Malignant neoplasm Chemotherapy which ended in mid-September, 2000; steroid therapy (prednisone) which also ended in mid-September; vaccine reaction, lymphoma WAES00120855 1
0165643 02/07/2001 ND 60.0 60 F 02/01/2001 On 12/5/00, post vax, the pt experienced a reaction on her arm. She presented with diffuse erythema of upper right arm extending into axilla and down to her elbow. It was tender to palpation and hard to touch. In follow-up, the PA reported that the pt was seen on 12/7/00. The pt told the PA that she thought she was having an allergic reaction to the pneumococcal vaccine 23 polyvalent. She reported that within a few hours, post vax, she noticed redness, swelling and pain in the arm. This had progressed over the past day and now she had redness down the elbow and up into the axilla and back onto the right shoulder. On exam, the PA noted she had confluent, erythematous and a somewhat fluctuant area extending from the right axilla down to the right elbow. The fluctuance was mainly over the biceps but the tenderness to palpation was more noticeable in the right axilla and right posterior arm at the base of the right shoulder. The pt stated that she had some chills on 12/6/00. The pt took some extra strength Tylenol on 12/6/00. Pt reported she did not feel ill, just occasionally felt feverish. The affected area did not blanche to palpation. At this time the PA assessed the pt's condition as an allergic reaction to pneumococcal vaccine 23 polyvalent. The pt was given Benadryl 50mg IM and was advised to take 25-50mg every 6 hours. A line of demarcation was drawn around the erythematous area. The pt was advised not to take any acetaminophen if she started to feel like she had a fever until she took her temperature and to record it. If her temperature was over 100F she was to take acetaminophen. On 12/8/00, the pt was seen again by the PA. The pt reported that she was "much improved" and had no further chills. Her temperature has been normal and the redness was "resolving nicely". On exam, PA noted that the erythema was fading, however, it had spread down her upper arm to just below the elbow but was resolving on the shoulder area and upper arm. He noted that the area "looks much better than yesterday". The PA's assessment of the pt's condition was that she had an allergic reaction to pneumococcal vaccine 23 polyvalent. The pt was advised that she should take Benadryl on an as needed basis. The pt was also advised not to be vaccinated with this vaccine in the future. Additional information has been requested. The allergic reaction, diffuse erythema of the upper right arm extending into axilla and down to her elbow, and tender to palpation were considered to be an "Other Important Medical Event." F/U The pt's adverse experiences were considered to be other important medical events by the reporter. Follow -up info rec'd from the physician's assistant indicated that the pt adverse events improved with Benadryl and tylenol. It was reported that the pt recovered on 12/7/00. No further info is expected. Y Y 12/05/2000 12/05/2000 0 BP-147/81; Temp-99.1F; Pulse-88. On 12/8/00 BP-156/80; Pulse-81. PUB UNK Combivent, Lotrel, beclomethasone dipropionate, chlorthalidone Allergy, aspirin; COPD; rhinitis WAES00120597 1
0165645 02/07/2001 KS 46.0 46 F 11/17/2000 The patient had vaccination, 3 days after her injection she noted a rash in her lower extremities, severe abdominal pain, and diarrhea followed. She saw an immunologist on 11/07/00. The doctor did a skin test ( had throat swelling). Diagnosed with hypersensitivity vasculitis from the Flu vaccine. Recurrence more rash in the upper abdominal area, pain, diarrhea on 11/09/00. Finally the patient was admitted on 11/11/00 for 3 days. Y 3 Y 11/02/2000 11/05/2000 3 CBC, Compreh. Metabolic panel and amylase - WNL. WBC - 17,000. PUB PVT Claritan, Rhinacort, Albuterol NONE Seasonal allergies Throat swelling and paralysis~Influenza (Seasonal) (no brand name)~~0.00~In Patient KS200026 1
0165646 02/07/2001 IL 0.2 0 .2 M 02/02/2001 This infant had periorbital edema, hives on his arms and legs, and lip edema. Y Y 01/30/2001 02/02/2001 3 PVT PVT Nasal Congestion. NONE 1
0165647 02/07/2001 PA 0.3 0 .2 M 02/01/2001 This child had 1st dose of DPT (Acel-Immune), IPOL, Comvax, and Prevnar vaccine. He developed irritability and crying episode for 4 - 5 hours on the same day, evening after the immunization. Y 12/08/2000 NONE PVT PVT NONE The parents thin there may be a possible allergy to soy formula. 1
0165648 02/07/2001 KS 3.0 3 M 10/27/2000 This child had pain, redness, and swelling to the injection site; the pain was radiating down his leg. The child did not want to bear weight on his leg. His fever was controlled with 1 dose of Advil, no temp at office, fussy at home. The child was alert, verbal, and active at the office visit. Y 10/25/2000 10/26/2000 1 NONE PVT UNK NONE NONE KS200024 1
0165649 02/07/2001 KS 0.3 0 .3 M 12/22/2000 This baby received vaccines on 12/20/00 at 3 PM. The mother states that a "rash" started at midnight and "came and went" ; the baby also did not sleep all night. The patient presented to the Health Dept Pediatrics 12/21/00 and was seen by 6:30 PM. The doctor sent the father to Osco to get Benadryl so a dose could be given and the baby observed. Hives progressed to the point that the doctor wanted the baby to go to the ER. 911 was called and the baby was transported before Benadryl was given. Y Y 12/20/2000 12/20/2000 0 PUB PUB NONE NONE NONE KS200032 1
0165650 02/07/2001 OK 0.2 0 .2 M 01/09/2001 This infant had a fever and generalized swelling all over his body. The patient was seen in the local emergency room. Y Y 11/13/2000 11/13/2000 0 NONE PVT PVT NONE NONE 1
0165651 02/07/2001 PA 54.0 M 02/01/2001 This patient is reported to have dizziness, headaches, joint pains, decreased eyesight. Report 2001002642-1 describes dizziness in a 54 year old male who received an injection of Lyme disease vaccine (Lymerix). This report was received from the patient's spouse and has not been confirmed by a physician or other health care professionals. Concurrent medical conditions included prostate cancer diagnosed "years ago" and allergy to Leuprolide (Lupron). The patient has no history of Lyme disease. The patient has no personal or family history of gout, Crohn's disease, psoriasis, rheumatoid arthritis, or lupus erythematosus. Concurrent medications included an unspecified hormonal injection. The reporter stated that the patient received his first injection of Lymerix approximately on year prior to 02/01/01; however, she is unsure of the date of administration, and the information supplied does not comply with the recommended dosing schedule for Lymerix. At an unspecified time following receipt of the first injection, the patient developed dizziness, headaches, and joint pains. These symptoms persisted. The patient then received his second injection of Lymerix, also "approximately one year ago" from 02/01/01. The dizziness, headaches, and joint pains continued to persist. The patient received his third injection of Lymerix in June 2000. The dizziness, headaches, and joint pains persisted. The reporter stated that all the patient's joints are affected. No joints are red or swollen. The patient has not had a physical examination within the last year. On 01/22/01, the patient experienced decreased eyesight with blurred vision. He was seen by an "eye doctor", who reportedly was "puzzled" by the "extreme" change in the patient's eyesight, which was "down by five". As of 02/01/01, the dizziness, headaches, joint pains, and decreased eyesight persisted. The adverse events of dizziness, headaches, and joint pains do not meet ICH serious criteria, but being submitted as an expedited report by special FDA request per the June 28, 2000 letter. N PVT OTH Unspecified hormonal injection Allergy to Leuprolide (Lupron), Prostate cancer. 20010026421 1
0165652 02/07/2001 KS 44 F 11/29/2000 On 11/22/00, this patient was nauseated and achy all over. On 11/23/00, she felt achy and feverish, her left arm reddened and edematous; a bit larger than a 1/2 dollar. The edema went down gradually over several days. The patient complained of eyes feeling itchy on 11/24/00. The patient took Benadryl for several days. Y 11/22/2000 11/22/2000 0 PUB PUB Vicodin, and Percocet. Back pain, hospitalized 11/7/00 - 11/11/00. Allergies to Keflex, Penicillin. KS200027 1
0165653 02/07/2001 KS 66.0 66 M 12/11/2000 This patient received a Flu vaccine on 12/04/00. The patient noticed hives on his back on 12/06/00. The hives continued to worsen, no respiratory distress involved. He was seen by the Doctor on 12/08/00. The patient couldn't verify if it was flu shot or not causing the hive episode. Y U 12/04/2000 12/06/2000 2 NONE PUB UNK NONE NONE KS200028 1
0165654 02/07/2001 KS 37.0 37 F 12/11/2000 This patient developed hives after receiving the Flu vaccine after about 4 hours. There was no respiratory distress, nothing else new or different in her life. This was her first flu shot. Y 12/04/2000 12/04/2000 0 NONE PUB PUB NONE Cold, no Temp. NONE KS200029 1
0165655 02/07/2001 KS 59.0 59 F 12/12/2000 This patient began feeling achy within 5 hours after receiving vaccine. The patient also noticed headache, chills; within 2 more hours hands felt tingly, and hands and feet felt cold. Her temperature was 100.5 the next AM and then 2 days later 101.3 in the AM, it resolved by the 3rd day. The patient still felt drug out and fatigued. Y 12/05/2000 12/05/2000 0 NONE PUB PUB NONE NONE KS200030 1
0165656 02/07/2001 NH 52.0 52 M 01/24/2000 This patient had tingling in his arm, pain, and inability to use his right arm. Y N 11/29/2000 11/29/2000 0 OTH PVT PPD, right forearm, lot # L0519AA NONE NONE 1
0165657 02/07/2001 KS 43.0 43 M 10/21/2000 This patient has diffuse paresthesia from the chest down, numbness of the fingers and toes. Lasting continually for 2 weeks. Y 10/14/2000 10/14/2000 0 CBC, Chem, BH - Nml OTH PVT NONE NONE NONE KS200025 1
0165658 02/07/2001 ME 54.0 54 F 01/26/2001 Within hours of injection, patient developed pain, slight swelling, and some erythema at left deltoid. She experienced loss of abduction and limited flexion and extension of left shoulder. She was referred to PT for rehabilitation of left shoulder. She had 50% improvement in range of motion within 48 hours. Her diagnosis was arthritic reaction versus injection into rotator cuff. Y 01/23/2001 01/23/2001 0 UNK PVT NONE NONE ME01003 1
0165660 02/07/2001 SD 1.5 1 .5 M 02/05/2001 Patient developed a hoarse cough and elevated pink/red rash on trunk of body. The incident was reported to physician and family was instructed to give Benadryl. On 2/2/01 the rash was reported to be gone. Patient's mother felt this was a reaction to Varivax because the patient developed a rash on left thigh Y 02/01/2001 02/01/2001 0 PVT OTH cold, slight cough chronic rhinitis, vascular birthmark right back-flank, hypopigmented patch right forearm 1
0165661 02/07/2001 TN 13.0 13 M 12/20/2000 Patient developed a fever of 103 to 104 degrees and severe diarrhea 3 to 4 days after receiving vaccine. The episode lasted 3 to 4 days. Y 03/15/2000 03/18/2000 3 NONE PUB UNK NONE Allergy to Sudafed fever, diarrhea~Hep B (Engerix-B)~~13.00~In Patient TN00050 1
0165662 02/07/2001 TN 0.75 0 .8 F 12/22/2000 Patient developed a rash all over her body. Y Y 12/14/2000 12/16/2000 2 NONE PVT PUB Atarax allergic rhinitis NONE TN00051 1
0165663 02/07/2001 TN 0.3 0 .4 F 12/22/2000 Patient developed an all over body rash after first and second sets. Y Y 12/19/2000 12/21/2000 2 NONE PUB PUB NONE NONE NONE Rash~DTaP (no brand name)~1~0.00~In Patient TN00053 1
0165664 02/07/2001 MO 5.0 5 F 02/05/2001 Patient developed a 5 X 3cm area surrounding site of injection on right thigh. The area was red, warm to the touch, and slightly swollen and raised. U 01/29/2001 01/30/2001 1 PVT PVT PVCC cough NONE 1
0165665 02/07/2001 AZ 51.0 51 F 01/04/2001 Patient developed soreness at site of injection and under arm in one area only on right side. Y 12/27/2000 12/28/2000 1 PUB UNK NONE past history of breast cancer, lymph nodes removed on right side AZ0101 1
0165787 02/07/2001 NY 25.0 25 F 01/29/2001 Patient was vaccinated on 3/13/00 with one dose of measles virus vaccine live. In 1993, the patient had received a first dose of measles-mumps-rubella in Ukraine. On 3/17/00 the patient had her titer checked and was found to be non-imune. On 5/27/00 a repeat titer was drawn which revealed that the patient had not developed immunity. U 03/13/2000 03/17/2000 4 03/17/00 rubeola AB (IgG) 0.61 I.S.R.-negative rubeola titer 7 weeks s/p vaccination 05/27/00 0.55 I.S.R.-negative rubeola titer UNK UNK UNK Ceftin allergy WAES00060715 1
0165788 02/07/2001 NY 35.0 35 F 01/29/2001 Patient received a fourth dose of measles virus vaccine live. The patient was a "non-responder" to the first three doses of measles virus vaccine live. After the fourth dose, the patient developed a fever, joint pain, and a headache. The patient had these symptoms for approximately 3 weeks. On 7/18/00, the patient was scheduled for a visit to a physician. Y N 06/28/2000 lack of seroconversion: inadequate measles antibodies UNK UNK UNK penicillin allergy WAES00071517 1
0165789 02/07/2001 NJ U 01/29/2001 Patient received a first and second dose of measles virus vaccine live. Subsequently, following the second dose, a titer done by the hospital lab was <0.9 (>=0.9 was considered positive). The patient sought unspecified medical attention. Y U measles AB titer <0.9 OTH OTH UNK UNK WAES00081513 1
0165659 02/08/2001 NY 0.5 0 .6 F 10/16/2000 The pt experienced vomiting episodes (multiple) within 24 hours of immunizations. Y 10/09/2000 10/09/2000 0 NONE PVT PVT Motrin NONE NONE 1
0165668 02/08/2001 FL 2.0 2 .0 M 02/05/2001 A physician reported that a 24 month old male received an injection of Prevnar on 1/26/01. Approx. 4 to 6 hours later, the child developed hypotension, stridor, retraction in all lung fields, delayed capillary refill and "severe" depression in breathing. The physician described this as an anaphylactic reaction. The child was seen in an ER. He was treated with fluids, Decadron and Benadryl. The child was hospitalized and discharged the next day. Anaphylactic reaction is considered "Medically Important". Y Y 1 Y 01/26/2001 01/26/2001 0 UNK PVT PVT NONE NONE Atrial septal defect NOS; operation NOS; food and drug hypersensitivities; Down's Syndrome HQ6701001FEB2001 1
0165670 02/08/2001 WI U 02/05/2001 A nurse reported that a patient received an injection of Prevnar and subsequently developed cellulitis at the injection site. The patient was hospitalized. No further information was available at the date of this report. Manufacturer's comment: The reporter indicated that 3 patient's experienced this event; however, they are not presently identifiable. Additional reports will be generated when identifying information is provided. Y U UNK OTH OTH UNK UNK UNK HQ6654731JAN2001 1
0165671 02/08/2001 WA 0.5 0 .5 F 01/30/2001 Pt had a fever, soreness (immediate) and Diabetes Type I (developed over time). Dx'd on 11/20/1999. Y Y Y 5 Y Y N 02/11/1998 02/11/1998 0 Diabetes Type I PVT OTH NONE UNK NONE Unspecified reaction~Vaccine not specified (no brand name)~3~0.00~In Patient 1
0165672 02/08/2001 CA 0.7 0 .7 M 01/31/2001 The pt experienced acute demyelinating encephalomyelitis. Y 5 Y 08/27/1998 02/28/1999 185 MRI - abn, labs - neg PVT PVT NONE NONE 1
0165673 02/08/2001 PA 30.0 M 02/01/2001 A pharmacist reported that a 30 year old male received an injection of Flu Shield '00-'01 on 11/1/00. On 11/3/00, the pt developed a fever, headache and shingles. On 11/13/00, he experienced numbness. An MRI showed plaques on the spinal cord that are similar to multiple sclerosis. The reporter also indicated that a neurologist believes that the pt's symptoms are a central nervous system disturbance. As of the date of this report, the pt still had a sensory disturbance of his lower extremities. Neurological disorder is considered "Medically Important". Y U 11/01/2000 11/13/2000 12 MRI-spinal cord plaques PVT OTH UNK NONE UNK HQ6660331JAN2001 1
0165674 02/08/2001 CT 74.0 74 M 06/12/2001 A spouse reported that her 74 year old husband developed atrial fibrillation and polymyalgia rheumatica approximately 3 weeks post vax. He was then prescribed Lasix for his heart, Coumadin for his blood, prednisone for his PMR and synthroid for his thyroid. He had previously not been on any medication and had no medical problems. He has has previous flu shots in the past without any problems. His symptoms included achiness in his hips, thighs and calves. He normally works out at a club three times per week, but has not been able to return to that activity. Additional information has been requested. Follow-up information received on 4/24/01, states that the physician identified as PCP wrote: "I did not administer a flu shot to this patient". Additional information received on 06/05/2001, states that the day after receiving the flu vaccine, the pt woke up with severe pain in thighs, calves, and hips. A few days later, joint pain began. This pt also had fever to 102 and lost 22 lbs. The family physician started him on prednisone, plaquenil,and NHAID with good effect. As of 06/22/2001, his positive RF has persisted. Y N 10/10/2000 10/11/2000 1 MIL OTH NONE NONE MPI200100047 1
0165675 02/08/2001 CA 0.3 0 .4 M Patient developed fussiness at 2 AM on 1/6/01 followed by a fever of 103 degrees and inconsolable crying for 1.5 hours at 4 AM on 1/6/01. Patient was given Tylenol at 2 AM. Y 01/05/2001 01/06/2001 1 NONE UNK UNK NONE NONE NONE 1
0165676 02/08/2001 NY 13.0 13 F 02/07/2001 The pt experienced a tonic-clonic seizure 2 minutes post vax, lasting a few seconds. The pt has no hx of seizure activity and no other contributing past medical hx. Additional information has been requested. Y 01/13/2001 01/13/2001 0 PVT OTH NONE NONE MPI2001000320 1
0165677 02/08/2001 MT 45.0 45 F 01/24/2001 At 7:00PM the pt experienced s cough, then severe chills, nausea and headache lasting 12 hours. Her eyes were red, no white visible for 36 hours. Went to bed and took store brand Excedrin. Y 12/08/2000 12/08/2000 0 PUB OTH Allegra, Vitamins, Calcium, Gingko Biloba NONE allergy to dust, grass, trees, mold etc. 1
0165678 02/08/2001 MO 1.2 1 .2 M The pt had a sterile reaction with swelling and erythema of the right anterior thigh. Y 11/07/2000 11/09/2000 2 PUB PUB NONE MO2001002 1
0165679 02/08/2001 TX 25.0 25 F 11/30/2000 The pt experienced a rash around the neck within one week of vax. The pt also experienced faintness, erythema, splotchy. Was treated with Claritin. Symptoms have resolved. Y 11/02/2000 11/04/2000 2 PVT PVT Ortho Tri-Cyclen NONE 1
0165680 02/08/2001 TX 1.04 1 .0 M The pt experienced morbilliform rash to trunk, face, extremities. 12 days post vax. Y Y 01/03/2001 01/15/2001 12 PVT UNK cough NONE 1
0165769 02/08/2001 NJ 37.0 37 F 01/11/2001 On 12/7/00, pt noticed a "burning sensation" on 1st injection of Rabies. Did not mention to RN. That night she experienced numbness and tingling of right hand. The problem reoccurred, intermittently, only at night. On 12/25/00, numbness began to radiate from hand to elbow, again intermittently and only at night. Approx. on 1/5/01, it became "severe", lost ability to grip, had problem day and night for approx. 2 days. Informed supervisor on 1/6/01. On 1/9/01, numbness subsided, somewhat. Client reports has been lessening. N 12/07/2000 12/07/2000 0 NONE PUB PUB NONE NJ20014 1
0165711 02/09/2001 GA 0.5 0 .5 M 01/10/2001 Pt had a high fever of 103F and vomiting at 21:00. Seen in ER and in the hospital from 9/18/00 until 9/21/00. Mom reported this to health dept on 1/8/01. Y Y 3 Y 09/18/2000 09/18/2000 0 Mom states all blood test were normal PUB PUB NONE Asthma GA01003 1
0165714 02/09/2001 WA 1.2 1 .2 F 01/20/2001 Pt developed diabetes over time. Dx'd 11/20/99 with Diabetes Type I. The follow up received on 6/19/01 states, "Thank you for referring pt to our clinic for consultation regarding diabetes management. As you know, pt was diagnosed with diabetes on October 20th. She was initially hospitalized, having large ketonuria and a blood sugar over 480. The parents state that things have been going reasonably well, although they find it very difficult to manage pt's diabtes. They feel that her blood sugars fluctuate drastically. She has not had any siezures. She has had a blood sugar as low as 25, at which time she wsa very groggy. She had another hypoglycemic event, with a blood sugar of 35, at which time she could not walk. She has had some blood sugar swings up into the 400's and 500's. However, in reviewing her blood sugars for the past few weeks, most of the blood sugars have been between 100 and 300. The parents have been talking with you for insulin adjustments, and numerous appropriate insulin adjustments have been made over the past six weeks or so. She is currently taking 4 1/2 units of NP and 1/2 unit of regular in the morning and no insulin in the evening. Upon awakening, her blood sugars have generally been in the 100 to 300 range. Pt is eating fairly well. She has three meals and three to four snacks per day. If her blood sugar is high, her snack is generaly withheld. Occasionally she will refuse to eat, and then the parents feel in a panic that hse is going to have a hypoglycemic event soon afterward. Pt has been back to her normal energy level and routine. She is still nursing occasionally, although the mother has been trying to limit the amount that pt is breast feeding. The mother had been fairly close to weaning pt at the time of the birth of pt's 6 month old sibling, but between that and then the diagnosis of diabetes a few months later, pt has continued to breast feed. The parents come in with several questions today. They are wondering whether the fluctuations in pt's blood sugars are typical. They also wonder whether pt's younger sister should receive immunizations, as they have read that immunizations may be the cause of the increased prevalence of diabetes in young children. They do note that pt's blood sugar tends to fall rahter quickly after Humalog insulin, and it also falls in the mid-afternon, between 1 and 2pm. They find it difficult to give pt extra Humalog insulin, asthey are unsure if her blood sugar is going to fall from previous insulin dosages. In looking at pt's blood sugars at bedtime, of late she frequently has been going to bed with relatively high blood sugars, i.e. over 200." Follow up: "Actual date is unknown. Onset was very gradual. Destruction of Islet cells which produce insulin can be immediate or take several years." Y Y Y 5 Y Y N 11/09/1998 Diabetes Type I; hemoglobin Alc is 8.5%. The parents state that the hemoglobin Alc was 10 at the time of diagnosis. PVT UNK UNK NONE Unspecified reaction~Vaccine not specified (no brand name)~1~0.00~In Patient 1
0165718 02/09/2001 OH 20.0 20 M 01/14/2001 On 12/31/00, pt developed some muscle aches and pains. By 1/1/01, he had severe myositis/joint pains/weakness and could not walk or even feed himself. Admitted to hospital on 1/1/01 to rule out Guillain-Barre Syndrome and other causes. All tests were normal. Y 3 Y 12/19/2000 12/31/2000 12 Spinal Tap; MRI; EMG; Blood work-All WNL PVT PVT NONE NONE Possibly PCN allergy 1
0165719 02/09/2001 AL 0.5 0 .5 M 02/07/2001 This infants right thigh turned red and had swollen 30 seconds after administration of Prevnar vaccine. Ice was applied to the area and Benadryl was given. Mom stayed in the office 30 minutes after the reaction to the med. The mom was instructed to call if fever, swelling increase or became irritable U 02/07/2001 02/07/2001 0 PVT PUB NONE 1
0165721 02/09/2001 WI 0.2 0 .2 F 02/05/2000 The infant is screaming and crying. Y Y 02/01/2001 02/02/2001 1 NONE PVT PVT NONE NONE 1
0165722 02/09/2001 NJ 0.3 0 .2 F 02/01/2001 After receiving Vaccinations the infant became very irritable, crying for 48 hours. Y 11/21/2000 11/21/2000 0 NONE PVT PVT NONE NONE NONE 1
0165723 02/09/2001 PA 0.2 0 .2 F 02/01/2001 Approximately 30 hours after receiving a vaccine series, the patient had a 20-30 second episode of "eye blinking" and drooling as well as "jerking" arms and legs. The episode was self limited, with no obvious sequelae. Y 01/29/2001 01/30/2001 1 EEG - results are pending PVT PVT NONE NONE 1
0165724 02/09/2001 IL 1.5 1 .5 F 01/25/2001 This infant had erythema 2 x 4 cm one day following immunization, Prevnar #2. At the time of Prevnar #1, she had the same reaction. Y 01/23/2001 01/24/2001 1 NONE PVT PVT NONE NONE NONE Erythema~Pneumo (Prevnar)~1~1.00~In Patient 1
0165725 02/09/2001 VA 1.2 1 .2 F 01/25/2001 Physician from a from another Pediatric facility inquired as to what immunization was given on 01/16/01. The patient presents today with 2 clusters of papules. The doctor said it was a local vaccine reaction. Treatment with Benadryl. Y 01/16/2001 01/25/2001 9 PUB PUB NONE 1
0165726 02/09/2001 ME 0.2 0 .2 F 02/01/2001 This patient had fine red colored rash appear on both legs around his injection sites within 1-2 hours of immunization and lower legs. Feeling today, no induration, swelling. No treatment needed. N 01/23/2001 01/23/2001 0 NONE PVT PUB NONE NONE 1
0165727 02/09/2001 GA 71.0 71 F 01/20/2001 On 01/19/01, this patient received her vaccinations in the PM. Her arm started to swell, sting, and she complained of pain, and severe redness for several days. The patient took Tylenol when necessary and Ibuprofen for 2 days. Today the swelling and redness is decreased. Y 01/19/2001 01/19/2001 0 PUB PUB Blood pressure, Vitamin E, and all purpose Vitamins. NONE Allergies to bee stings, wasp stings, and insect bites. Erythema. GA01006 1
0165728 02/09/2001 IL 28.0 28 F 01/25/2001 This patient had a rash on her face and upper chest area, it was itchy, and she had watery eyes. The patient took Benadryl and it resolved. Y 12/01/2000 12/01/2000 0 OTH OTH NONE NONE NONE 1
0165729 02/09/2001 MI F 01/12/2001 Immediately following this patient's injection she experienced numbness and tingling in her hand on the side where the injection was given. She also reports a flushed "hot" sensation all over. Obese sickness had completely resolved within 2 hour or less, and there were no residual effects. Follow up: Patient lost to follow-up, cannot contact. Y 01/05/2001 01/05/2001 0 OTH PUB UNK NONE Migraines MT0105 1
0165730 02/09/2001 TX 2.0 2 .8 M 01/12/2001 This patient's mother called, the patient vomited 2 times in 6 hours after his vaccination was given. He was fine within 12 hours. Y 01/11/2001 01/11/2001 0 PVT PVT 1
0165731 02/09/2001 TX 42.0 42 M 01/18/2001 This patient developed a sore throat with post nasal drip, a severe cough followed with a fever; within 2 days after his vaccination. Y 01/11/2001 01/12/2001 1 NONE OTH PUB UNK TX01004 1
0165732 02/09/2001 TX 59.0 59 F 01/16/2001 On Monday, 01/08/01, at 9 PM, the patient had a rash on her body. On Tuesday, 01/09/01, the patient experienced itching, hives and throat swelling. The doctor administered Cortizone treatment lasting 7 days. The patient stated by Thursday, 01/11/01, she had no signs of hives, itching, rash or throat swelling Y Y 01/08/2001 01/08/2001 0 NONE PUB PUB Esterol, Lipitro NONE NONE TX01003 1
0165733 02/09/2001 TN 1.39 1 .4 F 01/26/2001 Approximately 2 hours post vax, while eating chicken nuggets and honey mustard, the pt began to develop a rash around the mouth and tongue began to swell. Pt had no difficulty breathing. Pt was referred to Hospital. ER physician diagnosed oversensitivity. Y Y 01/26/2001 01/26/2001 0 PUB PUB NONE NONE TN01004 1
0165734 02/09/2001 NC 31.0 31 F 01/29/2001 Pt received Hep A and Td on 11/19/1999; on 11/23 pt developed red raised sensitive spot at vaccine site with 12x13cm area redness, pain. Pt received Cephlexin 500 bid times 1 week. Resolved by 11/26/1999. Y Y 11/19/1999 11/23/1999 4 PVT UNK Ambien, Tessalon NONE NONE NC00011 1
0165735 02/09/2001 NC 5.3 5 M 01/29/2001 Approximately 12 hours post vax, pt developed 6X7 cm warm indurated area around injection site with no pain or fever. Presumed local allergic reaction. Pt treated with Claritin10 mg, close clinical follow up. Event resolved within 48 hours. Y Y 01/23/2001 01/24/2001 1 PVT UNK NONE seasonal allergies; atopic asthma NC00012 1
0165736 02/09/2001 NC 0.08 0 .0 M 02/02/2001 4.5 X 5 cm nearly circular, erythema dredges, center clear with raised edges, blanch unchanged since onset. Y U 01/22/2001 01/24/2001 2 PVT PUB NONE NONE NC00013 1
0165737 02/09/2001 GA 0.5 M 01/10/2001 Mom states child would sleep for long intervals then wake up screaming until he threw up. Reports fever of 101.6 last pm, this AM low grade fever, left leg has large knot, red and swollen. On phone call all night with 250Kids hotline. Y 01/09/2001 01/09/2001 0 PUB PUB NONE NONE GA01005 1
0165738 02/09/2001 GA 0.2 0 .2 M 01/17/2001 Four days post vax, mom reported the pt was fussy and spitting up. Reported wheezing. Pt was seen by physician six days post vax who stated symptoms were due to stomach problems and treated with Prevacid. Y Y 01/10/2001 01/14/2001 4 PUB PUB colic colic GA01004 1
0165739 02/09/2001 GA 1.33 1 .3 F 12/15/2000 12/13/00 pt was given DTaP given at Health Dept. 12/15/00 seen at HD with caregiver, no fever. Reports child able to play, walk normal act at this age. Left thigh redness and warm to touch, measures 3x2 inch. Y 12/13/2000 12/15/2000 2 PUB PUB NONE NONE GA01002 1
0165740 02/09/2001 GA 0.2 0 .2 F 01/12/2001 On 1/9/01 child began having diarrhea, loose brown 5-6 times day, no vomiting, taking bottle. Only small amount temperature did not take it, playing, still having diarrhea today when went to Dr. 1/12/01. Y Y 01/08/2001 02/09/2001 32 NONE PUB PUB NONE NONE unable to read GA01001 1
0165741 02/09/2001 GA 0.3 0 .3 M 01/26/2001 Swollen, redness, cool compress applied to leg. U 01/22/2001 01/26/2001 4 PVT PUB 1
0165742 02/09/2001 GA 2.0 2 .2 M 01/31/2001 Right thigh red and swollen. Y 01/23/2001 01/25/2001 2 PVT PUB NONE NONE NONE 1
0165743 02/09/2001 TN 1.6 1 .6 F 01/04/2001 On 1/3/01 the pt experienced a rash that started at the injection site on arms and legs and worked down legs and arms. The rash was fine that turned red. Cheeks were red and there was a rash on the stomach. 1/4/01 the pt was holding joints like they were hurting. The pt was also cranky and had diarrhea. Saw an MD who said it was an allergic reaction to the vaccine. Y U 12/29/2000 01/03/2001 5 PVT OTH NONE NONE ~DTP (no brand name)~~0.20~In Sibling TN01001 1
0165744 02/09/2001 TN 1.0 1 .0 M 01/18/2001 The pt developed a fever of 102 approximately 1-2 hours post vax. The mother found the infant in his bed with eyes wide open and with a fixed stare. She said the infant was limp for approximately 2-3 minutes. She immediately called 911 and the infant was transported by ambulance to the ER. The infant was observed for 23 hours. The infant was diagnosed with a seizure. No prescriptions were given and the pt has not experienced any sequelae. The pt's maternal great uncle and great-great grandmother have a hx of seizures beginning in childhood. Y Y 12/29/2000 12/29/2000 0 UNK PUB PUB NONE NONE NONE TN01003 1
0165745 02/09/2001 IN 1.6 1 .8 F 01/09/2001 The pt experienced a fever of 103 at 2:00am on 1/3/01. The pt also experienced "jerky movements" seen at the ER. The pt was diagnosed with febrile seizure. The pt was treated with Tylenol, and Motrin. Y U 01/02/2001 01/03/2001 1 PUB PUB NONE TN01002 1
0165746 02/09/2001 IL 1.3 1 .3 F 02/01/2001 Approximately 10-14 days post vax, the pt developed flu-like symptoms and a seizure was experienced. No fever was present. Y Y 11/20/2000 12/06/2000 16 CBC, lytes, CT, UA, - all normal PVT PVT NONE flu-like symptoms NONE 1
0165747 02/09/2001 NC 3.9 2 .9 F 02/02/2001 The pt experienced multiple papules and pustules. Y 04/16/1999 01/31/2001 656 observation OTH OTH NONE NONE NONE 1
0165748 02/09/2001 NY 0.3 0 .4 F 02/01/2001 Within 1 hour post vax, the pt developed generalized swelling of whole body including face and eyelids. Was seen at the ER on 9/14. Y Y 09/10/2000 09/10/2000 0 PUB PUB NONE NONE 1
0165749 02/09/2001 OH 1.5 1 .6 M 02/05/2001 The pt experienced induration to the left leg. Y 02/02/2001 02/03/2001 1 PVT PVT 1
0165750 02/09/2001 MI 14.0 14 F 02/05/2001 1-2 days post vax, the pt has a pimply rash at the site. The area later became red and hard. Treated on 1/26/01 with Benadryl and steroids. Y 01/12/2001 01/13/2001 1 NONE PUB PUB allergy medication NONE allergy to cats, trees, grass 1
0165751 02/09/2001 MN 4.0 4 M 02/01/2001 Pt received DTaP vax in left upper thigh, developed surrounding redness/swelling. Seen 2/1/01 had mild redness 8cm surrounding injection site, mild swelling, no tenderness, no secondary cellulitis. Y 01/29/2001 01/31/2001 2 NONE PVT UNK NONE URI 1
0165752 02/09/2001 WV 44.0 44 F 02/01/2001 Pt reports soreness, tenderness and pain in right upper arm area. Developed shortly after Td booster, unresolved three months later. Pt denies any swelling or erythremia in right upper arm following injection. Palpation of right upper arm reveals no erythremia, or swelling, no lumps, and although patient states arm is sore in this area, no guarding or flinching occurs during palpation. Pt reports pain in right shoulder area that prevents her from sleeping if she rolls over onto it in her sleep. Pt reports pain with excessive movement. Pt reports regular use of Tylenol has not resolved pain. Pt also reports increased soreness and stiffness in right shoulder area upon waking in the morning. N 11/03/2000 11/04/2000 1 PUB PUB NONE Denies any pre-existing, reports spinal meningitis at age 10. WV0104 1
0165753 02/09/2001 TX 38.0 38 F 01/19/2001 Pt experienced hives and urticaria approx. 2 hours, post vax. Treated with Benadryl po and symptoms subsided without complications. Y 01/09/2001 01/09/2001 0 NONE PVT PUB NONE NONE NONE TX01002 1
0165754 02/09/2001 TX 4.0 4 F 01/16/2001 Swelling, edema, erythema and tenderness to left leg. Treatment: Atarax every 6 hours, Tylenol every 4 hours and warm compresses. Did not keep appt. for follow-up. Attempted to contact by phone but no answer. Allergy reaction (local). U 12/15/2000 12/18/2000 3 PVT PUB NONE NONE TX01005 1
0165755 02/09/2001 TX 12.0 12 M 01/16/2001 Approx. 10:00, pt received IZ and approx. 15 minutes, no side effects reported. Mother returned at 14:00 with client who had a fine rash to body. No difficulty breathing. Was advised to see PMD. Y Y 01/16/2001 01/16/2001 0 NONE PUB PUB NONE TX01006 1
0165757 02/12/2001 WA 66.0 66 F 02/08/2001 A 66 year old female reported that she received an injection of Pnu-Immune 23 on 10/25/00. Within 3 hours of the vaccine administration, the patient was not feeling well. The following day, she developed an injection site reaction in her left arm characterized by swelling, redness, and pain which extended through her left shoulder, mid-back, and neck. She was seen by the physician and diagnosed with necrotizing cellulitis. The patient was hospitalized on 10/26/00. An MRI was performed; however, the results were not available. The reporter stated that the physician felt she was "going into shock" and central venous line was inserted. She was treated with IV fluids, Unasyn (Ampicillin / Sulbactam) and Morphine. The patient was discharged on 10/27/00 with an unspecified antibiotic. Reporter also states that the physician felt she was "allergic to the Pneumonia vaccine". Follow up information received from the physician on 03/07/2001 indicated the patient was diagnosed with angioedema and injection site edema rather than fasciitis/shock. The patient's symptoms resolved rapidily and she recovered. Y Y 1 Y 10/25/2000 10/26/2000 1 MRI-results not available PVT PVT Plendil, Premarin NONE Hypersensitivity NOS HQ6824505FEB2001 1
0165758 02/12/2001 PA 68.0 M 02/08/2001 Report 2001003270-1 describes knee joint pain in a 68 year old male who received Lymerix. This report was received from a lawyer and has not been verified by a physician or other health care professional. Allergies, medical history, and concomitant medications are not specified. In 1999, and in early 2000, the vaccinee received his first and second doses of Lymerix, respectively. "Shortly" after dose 2 of Lymerix, the vaccinee developed such severe pain in his joint that he was unable to work. He subsequently under went exploratory surgery in July, 2000, and reportedly was told that he will need knee replacement. This report is considered serious due to the need for hospitalization and the inability of the vaccinee to work. As of 02/01/01, the out come of the event is unknown. The serious adverse event of "knee joint pain" is being submitted as an expedited report by special FDA request per the June 28, 2000 letter. Y Y U OTH OTH Allergies, medical history, and concomitant medications are not specified. 20010032701 1
0165759 02/12/2001 PA 43.0 F 02/08/2001 In March, 1999 and May, 1999, the vaccinee received her 1st and 2nd dose of Lymerix, respectively. Following the 2nd dose, the vaccinee experienced what she described as severe disabling joint pain all over her body. This pain then localized in her back, neck, knees, elbows, fingers and jaw. The pain tends to get progressively worse as the day goes on. When it is bad in her knees, she has difficulty walking by the end of the day. On days that the pain strikes her elbows, she had difficulty lifting by day's end. Due to the extreme fatigue she has experienced, she is forced to go to bed by 19:00. This case is considered serious because the events are disabling. As of 2/1/00, the outcome of the events is unknown. Y U 05/01/1999 OTH OTH HLA-DR4 positive 20010032641 1
0165760 02/12/2001 TX 54.0 F 02/08/2001 A nurse reported that a pt received an injection of Pnu-Imune-23 on 1/31/2001. The following day, the pt developed a fever of 102F and an injection site reaction characterized by redness and soreness. The pt was hospitalized and treated with unspecified antibiotics and steroids. As of the date of this report, the pt's symptoms were improving. Follow-up info received from the physician on 3/7/01, indicated that the pt was a 54 year old female. She recovered. Y Y 01/31/2001 02/01/2001 1 UNK PVT OTH Plaquenil; Prednisone; Medrol; Prilosec; Synthroid; Vioxx UNK Rheumatoid arthritis; Celiac disease; Hypothyroidism; Myasthenia gravis HQ6826305FEB2001 1
0165761 02/12/2001 TX 14.0 14 F Rash on body (hives) which occurred 5 hours, post vax. Pt was treated with Benadryl at home. Did not see MD, but reported event by phone. Y 01/19/2001 01/19/2001 0 PVT UNK Stomach ache; URI TX01007 1
0165762 02/12/2001 FL 1.0 1 .0 M 02/07/2001 Reddened, firm and warm to touch area at right thigh. Y 02/05/2001 02/06/2001 1 OTH OTH NONE 1
0165763 02/12/2001 IL 1.25 1 .3 M 02/02/2001 Pt received DTAP, IPV and Prevnar vaccines during well child visit; went home and was ok. At 22:00, pt observed by parents to have a seizure while sleeping (eyes rolled back, clenched fist). Parents took him to ER where a fever was detected and also had respiratory symptoms. Pt here today, 2 weeks later, still with respiratory symptoms; OM. Y Y 01/19/2001 01/19/2001 0 CBC-WNL; Glucose, Bun, Lytes-All WNL PUB PUB NONE NONE 1
0165764 02/12/2001 NY 40.0 39 F 02/07/2001 The pt received her 1st injection of Lyme disease vaccine in the fall of 1998 and the 2nd dose 1 month following the 1st. She had no adverse experiences following receipt of the 1st two injections. The pt received her 3rd injection of Lymerix, 1 month following the 2nd one. Approx. 1 month following the 3rd injection, the pt developed right elbow edema, redness, pain and heat. She also developed bilateral ankle edema; no redness or heat was noted in the ankles. She experienced cervical pain at times. She also experienced joint pain in both shoulders; the pain was worse in the right shoulder. The right shoulder pain continued to worsen over the next 2 years. The pt reported that she had not been seen by a physician at the time of "flare ups", but planned to be evaluated by an orthopedic surgeon. N 07/28/1999 08/01/1999 4 PUB PVT Vioxx, Celebrex Allergy to codeine 20010029031 1
0165765 02/12/2001 CT 51.0 51 M 02/14/2003 The pt works outdoors as a contractor. The pt received his 1st injection of Lymerix on 6/1/99. He was seen by his physician for physical exam on 6/20/99. At that time, he reported numbness of his hands in the morning. The pt was instructed to exercise and stretch his hands and wear wrist splints at night. During that visit, the pt received his 2nd injection of Lymerix and at some time later, the pt began to experience arthralgia and numbness of both hands. Early carpal tunnel syndrome was suspected and EMG tests were performed and interpreted as normal. In 7/00, a Lyme titer was negative and the pt was referred to a physician at a tertiary care center. On 9/15/99, the pt reported to his PMD that the consultant stated, "there was a 1 in 15 chance of the pt having a reaction to the Lyme vaccine." The consultant prescribed Vioxx. Prior to this, the pt had self-medicated with Motrin. The pt was seen by his PMD on 1/20/00 and at that time he reported experiencing arthralgia and numbness of his hands for 1 month. The physician's impression was "probably carpal tunnel syndrome" and the physician prescribed pyridoxine and wrist splints to be worn at night. The pt was seen again by his PMD on 9/15/00. The arthralgia and numbness of his hands persisted, and had extended to involve his shoulders. He had not been feeling well overall. The pt reported that his symptoms had begun after receiving Lymerix. He reported that a hot tub had been helpful in controlling his symptoms. He continued to take both Vioxx and Motrin. No swelling, stiffness or limited range of motion was noted on physical exam. The physician's assessment was recorded as "vaccination complications reaction (allergic), generalized anxiety, numbness, arthralgia hand and shoulder region, allergic rhinitis due to pollen." On 02/11/2002, in a statement of injuries, the vaccinee's attorney alleged that the vaccinee "has suffeed from debilitating joint pain and swelling in both wrists, hands and shoulders. In addition, he suffers from fatigue and amlaise." Outcome of the alleged were not specified. The adverse events "arthralgia" and "joint swelling" are being submitted as an expedited report. A 15-day follow up report received 09/09/2003 adds: The pt returned to his primary physician on 11/18/2002 with a complaint of "pain in his left shoulder and left side of his neck which seems to radiate down the left side." On physical examination, the physician observed "no joint swelling or evidence of acute inflammation noted, however he does have tenderness on palpation of his left shoulder more in the posterior aspect and lower shoulder blade region. He also has pain with abduction of his arm beyond 90 degrees. His neck is supple but he does complain of some tenderness on palpation of the posterior cervical vertebra and rotation of his neck toward the right is uncomfortable." The physician made a diagnosis of "Arthralgia Shoulder Region" and ordered X-rays. The X-rays revealed degenerative disease of the cervical spine; please see Laboratory Data section. The physician referred the pt to a physical therapist. The pt returned to his primary physician on 02/04/2003. He reported that "Physical therapy was helpful somewhat in relieving his symptoms but he continues to have some pain, and is particularly concerned about numbness in his fingers bilaterally." On physical examination, the physician noted "tenderness on palpation of posterior cervical vertebrae." The physician also noted that the pt "still has some stiffness in his neck and paresthesias in his hands, especially with activity." The physician made a diagnosis of "Spondylosis Cervical, with Myelopathy". He prescribed dextropropoxyphene napsylate with Darvocet N-100 and referred the pt to his neurosurgeon. On 05/05/2003, the physician noted, "Overall (the pt) is doing well." The most recent info, received on 08/20/2003, did not provide the outcomes of the reported events. Info received on 06/23/2003 provided diagnoses of cervical arthritis and myelopathy as the reason for the numbness and the "debilitating" shoulder pain. As a result, this report has been reclassified as serious, unexpected. As of 02/04/2003, the neck pain, shoulder pain, and hand numbness persisted. The pt was "doing well" overall on 05/05/2003. The outcomes of the other reported events were not provided. Y Y N 06/01/1999 06/28/1999 27 EMG-NML; 7/00 Lyme Titer-neg PVT PVT Humibid LA; Atrovent nasal spray; Nasonex; Saw Palmetto; Prilosec; Paxil; pravastatin; Valium; Claritin; Claritin-D; citalopram; Buspar Allergic Rhinitis; benign prostatic hypertrophy; chronic low back pain; Degenerative Joint Disease; Degenerative Lumbar Discs; Drug-induced erectile dysfunction, GERD, generalized anxiety disorder, Globus Pharyngeus;hyperlipidemia; lumbar disc herniation pain; lumbar surgery; panic attack; peptic ulcer disease; allergies to hornets/dust/ragweed/grass/trees/dogs; allergy testing and desensitization since 1978 2001002372 1
0165766 02/12/2001 MI 24.0 24 M 02/01/2001 After 3rd Rabies vaccine injection, pt's right upper arm experienced numbness and tingling in hand with loss of feeling in right hand for 5 hours duration. Complained of dizziness and feeling "just not right". Stated temperature was 103F-101F, during the night. No breathing or swallowing difficulties. Temperature is now 98.9F. Treated with Benadryl. Y Y 01/31/2001 02/01/2001 1 OTH PVT Allegra, Flonase NONE Environmental allergies 1
0165768 02/12/2001 NJ 0.4 0 .8 M 02/08/2001 Red, blotchy, urticaria rashes on face and scalp, as well as, chest and back about 2 minutes, post vax. Treated with Benadryl po. Y 02/08/2001 02/08/2001 0 PVT PUB NONE NONE 1
0165770 02/12/2001 TX 12.0 12 F 01/09/2001 Pt become nauseated and vomited, post vax, of HBV. Pt was layed down and informed she could leave facility once she was ok, if she did not have any problems. At 11:00, no complaints at this time to me other than a headache; has not eaten yet today. No nausea and vomiting currently and states she is able to walk now. Grandmother is taking her home and should eat. At 15:30, grandmother called and said pt still has a headache and took Tylenol. At 23:30, has eaten and kept food down, Informed to try ice pack and drink small amount of orange juice and try Advil or Motrin in about 2 hours. If problems persist or worsen, go to MD or ER. Informed that I would call and check on her tomorrow, if I did not hear from her again today. On 01/10/01 at 08:50, grandmother says child is ok and returned to school today. Y 01/09/2001 01/09/2001 0 PUB OTH NONE NONE NONE TX01001 1
0165771 02/12/2001 TX 4.0 4 F 01/30/2001 Per mother, around 12:00 on 1/26/01, right arm began to turn red and swell. Child began to complain of headache. Mom also began to notice child had chills and seemed to be acting like she was ill. Gave Tylenol for mild fever but temperature continued to climb. By 1/27/01 AM, child's temperature was 105F and arm had swollen to "the size of an orange". Per mom, her also was red and hot. Took child to ER, where they were told that she had had a vaccine reaction and released her home with Motrin. Follow-up visit with PMD arranged. Saw PMD and was told to use ibuprofen and continue with Motrin. Per mom, no redness or swelling, now. Y Y 01/25/2001 01/26/2001 1 PUB PUB NONE NONE NONE 1
0165772 02/12/2001 ND 38.0 38 F 02/07/2001 On 2/5/01, pt awoke with heart pounding, chest discomfort, SOB and pale. At 07:15, saw MD for signs and symptoms above. Pulse Oximetry-96%, P-114. Physician told pt that the cause of symptoms were likely, viral infection. Y Y 02/01/2001 02/05/2001 4 Pulse Oximetry-93%; P-114 OTH PVT Viral infection 1
0165790 02/13/2001 SC 0.2 0 .2 M 02/05/2001 This patient presented to ED in shock. The patient was then transported to PICU. The patient in shock requiring cardiopulmonary resuscitation. The patient expired approximately 72 hours after admission. The patient had received Prevnar the day prior to admission. Autopsy shows baby was cyanotic, not breathing Y 01/14/2001 Y N 01/11/2001 01/11/2001 0 UNK UNK prematurity (29 weeks), ROP 1
0165791 02/13/2001 AL 0.25 0 .2 M 01/19/2001 The pt died from sudden infant death syndrome on 1/6/01 within 18 hours of vaccine administration. Y 01/06/2001 N 01/05/2001 01/06/2001 1 PVT PVT NONE NONE 1
0165799 02/13/2001 ME 66.0 66 F 02/06/2001 On 12/19/00, the pt experienced progressive worsening fever, erythema, right arm pain, edema and induration. The pt was diagnosed by a physician with cellulitis. She was treated with oral Cephalexin for 7 days and two courses of IV Cephalexin as an outpatient in her physicians office. The pt's symptoms completely resolved by 12/29/00. Upon internal review the pt's experience was considered an other "important medical event". Additional information is not expected. Y 12/19/2000 12/19/2000 0 PVT PVT Lipitor, calcium, Prempro, Synthroid, Lopressor, Paxil, vitamin E COPD, fibrocystic breast disease, hypercholesterolemia, hypertension WAES01010845 1
0165812 02/13/2001 RI 37.0 38 M 06/25/2002 This 37 year old male patient was reported to have arthritis, aching joints, aching muscles, headache, hip pain, neck pain, and pain in the back of his arm. Report 2001003260-1 describes arthritis in a male of unspecified age who participated in a Lyme vaccine clinical trial (protocol and center number not specified) and reported his symptoms unsolicitedly after the conclusion of the trial. This report was received from a lawyer and has not been verified by a physician or other health care professional. On specified dates, the vaccinee received his first , second, and third doses of Lyme vaccine respectively. The vaccine recalled that after the second and third doses, and "possibly after the first dose" he experienced immediate symptoms and pain which included headache, neck pain, hip pain, back of the left arm pain, aching muscles and joints, which reportedly he reported to the study investigator. At the time, those symptoms were some what intermittent. However, he reported that his symptoms increased in frequency and intensity as time went on. Reportedly, he was becoming disabled, and he reported that he had been diagnosed with arthritis "throughout" his body. This case is considered serious since the vaccinee was "becoming" disabled. As of 02/01/01, the outcome of the events is unknown. F/U subsequently determined to be subject vaccine 215274, protocol LY008, Pt identification # 008,021,03205. On the study report form, the principal investigator indicated that these events were ossibly related to study vaccine administration. The additional info regarding some of the adverse events reported by the vaccinee was obtained from clinical trial records. The pt's medical history included asthma, which was treated with salbutamol. On 01/17/2001, the vaccinee's pulmonologist wrote a referral letter to an infectious disease specialist. In the lette,r the pulmonologist stated, "What is interesting about the vaccinee is that somewhere around 1995 he did participate in a Lyme vaccine study and he presents with a folder of information regarding Lyme arthritis in pts who have received the Lyme disease vaccine." The pulmonologist noted that the vaccinee underwent bone density scan by dual energy x-ray on 09/24/2000 which did rule-out osteoarthritis. The vaccinee returned to the neurologist on 03/15/2001. laboratory analyses performed on 02/15/2001 revealed erythrocyte sedimentation rate 4mm/hr, C-reactive protein 1.5 mg/L, creatine kinase 219 U/L, and negative rheumatoid factor. The neurologist's impression was lower back pain. The most recent info received on 01/24/2002 indicated that the chronic Lyme disease persisted as of 12/22/2001. At that time, the vaccinee was still able to work, however, because the vaccinee reported that he was becoming disabled, the activation of chronic Lyme disease and fibromyalgia are considered disabling. The follow-up received on 02/25/2002 states that the vaccinee was seen at a care center on 01/10/2001. The physician wrote, "He states that he was doing well until 1998 when he began developing hip, lower back pain, joint aches all over with some stiffness. He has had a workup that included a bone density scan which showed no evidence of osteoporosis. He has been taking Tylenol and intermittent Mobic for the pain which have not helped. He's still been able to work. He denies any fevers, dry eyes, dry mouth, any nodules on his skin, any rashes such as psoriasis or hair loss. He denies any pleurisy, abdominal pain or diarrhea. He has over the past six months developed worsened pain in his hips and his fingers. Sometimes it's hard to make a fist in the morning. He has quite a bit of stiffness in the morning. His back pain is particularly problematic, when he goes to bed after several hous he wakes up because his back hurts so much. He reports feeling stiff all day. He doesn't notice any particular swelling in the joints although he has trouble moving his right PIPs and MCPs. It's difficult for him to do his work because of the hand involvement and the back involvement since he has to lift and carry heavy objects. He's wondering that type of arthritis he might have, whether htis could be related to his vaccination." On physical examination,"Examination of the joints show some decreased range of motion in the PIPs and MCPs on both hands more so on the right compared to the left. Elbows still have ful range of motion without tenderness. Bilateral shoulders have some mild reduced range of motion. Impression: I cannot determine whether vaccination with the Lyme disease vaccine may have caused his symptoms." The physician ordered back x-rays to rule out sacroilitis and prescribed Vioxx daily. The most recent info received on 02/25/2002, did not provide the outcomes of the reported events. Info received on 01/24/2002 indicated that the chronic Lyme disease persisted as of 12/22/2001. At that time, the vaccinee was still able to work. However, because the vaccinee reported that he was "becoming disabled," the activation of chronic lyme disease and fibromyalgia are considered disabling. Following the reported onset of chronic Lyme disease, the vaccinee experienced abdominal pain, nausea, vomiting, chills, fever, increased serum amylase concentration, incresed serum lipase concentration, chronic gastritis, possible duodenal ulcer, pharyngitis, bronchitis, exacerbation of asthma, and thrush. These were not reported as adverse events due to vaccine administration, but were found during the course of review of the vaccinee's medical records. Therefore, they are not listed as adverse events. The physician referred the vaccinee to a locl rheumatologist for continued care. The vaccinee saw the local rheumatologist on 01/17/2001 "for evaluation of a rather acute pain in his left hip, morning stiffness, awakening with pain in his low back, and hand pain. He feels he has had some recent blurry vision. No iritis. Recently he has had some weakness in his legs and has had to drag his left leg. He has noticed a decrease in his grip strengt and has had some difficulty lifting sacks at work. He describes occasional "lightening bolts" of pain in his arms and legs on and off for the last year." On examination, "He had a limp. The examintion of his skin was significant only for an area of folliculitis behind his left ear. No sicca. His grip strength was reduced in his left hand more than the right. He ha dpain with more than 60% motion of his shoulders, was unable to squat to rise from the floor. The shober index is normal. He doesn't give a sleep history consistent with fibromyalgia, although the picture he drew of his skeleton was certainly consistent with that." The rheumatologist prescribed ibuprofen 600 mg three times daily. The restrcted duty form listed the "employee's medical problem" as pain, progressive arthralgia. Restrictions included walking to and from the bathroom only; sitting in a straight back chair; no lifting, pushing, or pulling, no cold, damp areas; no reaching or working above the shoulder; and no driving. The pulmonologist indicates that the vaccinee needed to use a cane. He also indicated that the vaccinee could work more than eight hours per day. However, as of 01/30/2001, the vaccinee was "now out of work because his employment was unable to find light duty for him." On 02/15, C-reactive protein concentration and erythrocyte sedimentation rate were within the reference ranges. Rheumatoid factor was negative. Creatine phosphokinase concentration was elevated. The vaccineew was seen by the local rheumatologist on 02/22/2001. At that time, he was "still not working. The neurologist treated him with mobic which caused tremendous heartburn. Started Celebrex 400 mg yesterday. NOne of the NSAIDs have helped at all, but he has never been able to take them longer than a few days to a week. His bone scan did not light up anything in the spine, hips or legs. I think the activity in his shoulders and chest is compatible with his job and age. He sleeps poorly and snores. Unclear whether he has sleep apnea. Today I don't see any inflammation in his hands or wrists. He is not tender over the right trochanter where there is a cyst and some "bone marrow edema." This is looking more and moe like fibromyalgia. I put him on amitriptyline 10 mg before bed each night. HIs CPK is essentially normal now." The vaccinee obtained a second orthopedic opinion on 04/03/2001 "for evaluation of multiple joint complaints of long-standing duration particularly involving the low back and both hips. He indicates that he has been having aching pain in his hips, back, knees, and upper extremities for several years. On clinical examination today, he gets onto and off the examining table slowly. He stands with his pelvis level and has a negative trendelenburg. He has full range of motion of both knees with no effusion. He has full range of motion of both ankles with no swelling. He is able to abduct and forward flex both shoulders to 135 degrees but there is no evidence of apprehension to abduction external rotation. He has full range of motion of both elbows and wrists. Grasp is full into both hands. There is no small joint swelling into his fingers. He has full lateral neck flexibility. He can forward flex his dorsolumbar spine to approx. 60 degrees with tenderness in the paralumbar region. There is no active paralumbar muscle spasming. Straight leg raising is to 90 degrees bilateraly in the seated position and to 40 bilaterally in the supine position. HIs hips are non-irritable with nonspecific inflammatory arthritis." The orthopedist recommended nonsteroidal anti-inflammatory medication and activity "as comfort dictates." The vaccinee returned to the local rheumatologist on 04/17/2001. He feels no better after two months of 10 mg amitriptyline. No side effects. Complains of total body stiffness, pain in his hip, right elbow, pain in his hands. Continues using a cane. Has returned to light duty work. Looks very depressed. Moving slow, using cane but his gait implies it is not necessary. Head hung low. Tender right lateral epicondyle. No other trigger points or tender spots. Exam of hands, wrists, elbows entriely normal. He has no limited motion of eiher hip or knee. Negative straight leg raising to 90 degrees. Since he feels Celebrex is not helping and he is now complaining of some "dyslexia," I stopped the Celebrex. Increase amitriptyline to 25 mg two hours before bed nightly. I refused to give him anote for light dutu work. At his reuest, I wrote a note for work stating that he has fibromyalgia, and the outcome depends on his sleep study and amitriphyline. If his sleep study doesn't show anything that can be improved with C-pap or other means to improve his sleeping, I think a consult with a psychiatrist would be helpful for his depression." A sleep study performed on 04/09/2001 revealed "no obstructive apneas. There were 13 obstructive hypopneas." The pulmonologist wrote," There does not appear to be any significant evidence for obstructive sleep apnea syndrome; nor a hyper-resistance airway syndrome. There are numerous spontaneous arousals that may be related to the pt's complaints of muscular pain and skeletal pain. There does not appear to be any significant evidence for a nocturnal myoclenus or restless leg syndrome." The vaccinee was seen by a third rheumatologist on 07/17/2001. At the time of evaluation,t he vaccinee was receiving clarithromycin and hydroxychloroquine therapy. "The vaccinee reports that since beginning on this treatment, he has had an increase in joint pain which has become more severe, but he claims that from what he reviewed on the internet and in the medical literature that his is typical of people being treated for Lyme disease. He reports that his social activity has declined dramatically." The rheumatologist noted that the vaccinee's father had arthritis and gout. On examination, "musculoskeletal exam fails to reveal any synvitis in his hands. He has good ROM at the wrists, elbows, and shoulders. Some stiffness with rotation at the hips and discomfort with passive ROM at the shoulders, hips and kness. However, he does not have any restricted ROM of any joints. There is no synovitis or joint effusions. He also has some tender points at the elbows, the shoulders, the paracervical and trapezios muscles, the lumbar region and hips. His multiple somatic complaints, and tender points on exam suggests the diagnosis of fibromyalgia as indicated by the local rheumatologist." The vaccinee was evaluated by an orthopedist on 09/20/2001. The examination "focuses on his lower back and leg complaints today. These are his primary complaints. He states increasing low back pain. he is three weeks into physical therapy without significant changes. In fact, he states worsening with radiation on a constant basis to the right foot with numbness and tingling is a similar distribution. He continued to complain of later hip pain as well. The pt's lower back is with marked pain with full flexion and extension. Straight leg raises test appears positive on the right, negative on the left, in a seated and supine position. Neurologic exam is intact with perhaps slight decrease pinwheel sensation to the lateral aspect of the right foot. Hip exam is with marked pain with full flexion and internal rotation as well as moderate discomfort with FABER testing. There is moderate to marked tenderness over the trochanteric bursa. Trendelenburg is with discomfort as well. There is right sciatic notch tenderndess. Mechanical low back pain with right leg radiculitis worsening. Trochanteric bursitis and trochanterio cyst." He recommended continuation of physical therapy. The vaccinee was seen by a second neurologist on 10/01/2001. "He has joint pain in the hips, knees. He has difficulty with numbness in the lateral aspect of the right lower extremity, extending from the hip down to the level of the ankle. He denies any bowel or bladder difficulty. He is unsure whether he developed any weakness in the leg." On physical examination, there was "some minor weakness of the extensor ballucis longus on the right otherwise the motor strength was graded as 5/5 throughout. Bulk and tone were normal. Sensory examination revealed an S1 deficit to pinprick in the right lower extremity with some patchy deficits over the L4-5 distribution as well on the right. Straight leg raising was markedly limited bilaterally. Gait examination revealed mild antalgia favoring the right lower extremity." The neurologist's impressions were "it appears that the vaccinee has low back pain and right lower extremity pain which may be radicular in origin. It appears he has an L5-S1 radiculitis without any evidence of active denervation in the limb or the paraspinals at this time. I suspect this is in part contributory to his symptoms, however, it also appears that there may be an arthritic component form the Lyme or other etiology. There is no evidence to suggest a peripheral neuropathy at this time." Various types of Lyme IgG western blot analysis were performed on 10/24/2001. The laboratory's overall interpretation was "one commercial WB yielded a positive result by DCD criteria. Prior studies suggest that this reflects a false positive and can be caused by vaccine alone." In an open letter dated 01/03/2002, the vaccinee's pulmonology nurse practitioner wrote, "His diagnosis is vaccine aggravated Lyme disease as per the second infectious disease specialist. He is going to continue on a therapeutic trial combining Clarithromycin 500 mg and Hydroxychloroquine 200 mg over the next few months. He will be cycled with Tetracycline His condition is not controlled. He is continuing to have joint worsening dysfunction. Currently his right shoulder reveals increased crepitus on rotation and has noticeable marked weakness and right shoulder drop. At this time partial or full recovery or remission is not expected. His activities are limited to extremely light duty with no lifting, with minimal standing, with sititng with occasional ambulation at least every hour and we expect that those restrictions will remain in place and may in fact need to be more restricted as time goes on to protect his joints." The most recent info received on 03/27/2002, indicated thatt he chronic Lyme disease persisted as of 01/03/2002. The vaccinee was seen by his primary on 07/11/01 for follow up Lyme disease. At that time, the pt stated that he was not feeling well and had complaints of diarrhea, nausea, and vomiting. Medications included Ventolin, Flovent, Biaxin, and Plaquenil. The physician's assessment was, "Drug Side Effect-Gastroenteritis." Biaxin and Plaquenil were discontinued. Trimethobenzamide hydrochloride was prescribed for relief of nausea and vomiting. Lab analysis revealed elevated concentrations of total bilirubin and lactic dehydrogenase. Lyme antibody screen was positive, but IgM and IgG Western blots were negative. Babesia IgG and IgM by immunofluorescent assay (IFA) were negative. Human granulocytic ehrlichiosis antibody screen HME IgG were negative. Plaquenil was restarted after three days. The most recent info received 05/28/02,did not specify the outcomes of the reported events. X-ray of the right hand revealed a "Probable old injury of the radial styloid." technetium bone scan performed on 01/25/01 revealed degenerative changes in sternoclavicular and acromioclavicular joints bilaterally and possible arthritis in both hands. Clinical correlation was recommended. On the referral form completed by the vaccines, he indicated that he had experienced back, hip and knee pain for five years. He indicated that the given diagnosis for the pain was "stenosis". Some stiffness with rotation at the hips, and discomfort with passive ROM at the shoulders, hips and knees. However, he does not have any restricted ROM of any joints. He aslo has some tedner poitns at the elbows, the shoulders, the paracervical and trapezius muscles, the lumbar region and hips. The vaccinee was seen by the third rheumotologist on 25 February 2002 for follow-up of chronic arthralgias. "He continues to be quite limited in his activities of daily living. He suffers from chronic fatigue, chronic joint complaints and occasional joint swelling. At times he feels that there is is swelling in his knees as well as hands. He finds that he is quite limited in his functional activities being able to lift or carry no more than 5 pounds. He has difficulty and limitations to bending, squating or climbing stairs. He is unable to be on his feet for more than an hour at a time before he must sit and rest. He is currently seeing a physician in Boston, who has put him on Tetracycline 500 mg tid (three times a day) which he has been on for the past month. However, to my opinion all of these antibiotics have not helped to relieve his symptoms very much. He has been taking some anti-inflammatories without much benefit. He has been working light duty at the post office, mostly as a sedentary and desk position. He continues to suffer with low back pain and hip pain. Previous MRI and x-rays have shown early degerative arthritis in the hip and central stenosis at L4-5 due to a bulging disc and x-rays and degenerative changes." On physical examination, " He continues to have very limited ROM (range of motion) of the lumbar spin. His hands fail to reveal any synovitis. He has tender points at the elbows, shoulders, throughout the spin especially the lumbar region, hips and knees. He has marked stiffness with flexion and rotation at the hips which is restricted by 50%. He as reduction of 50% ROM of the lumbar spine. There is som ecrepitus with flexion of the knees." The rheumatologist's impression was "Degenerative arthritis along with probable fibromyalgia remains symtomatic. He is prescribed valdecoxib. (Bextra) 10 mg daily in hopes of relieving some of his joint pain. Follow-up will be in 4-6 months. In my medical opinion he remains functionally limited due to his chronic pain, osteoarthritis and fibromyalgia. He shoud be restricted long-term/chronically to light duty at work lifting no more than 5 pounds, avoid stooping, squatting, kneeling, crawling or climbing of stairs. He should not be on his feet for more than one hour at a time. The most recent information received 25 July 2002 indicated that the fibromyalgia persisted as of 25 February 2002. The vaccinee was seen by a third rheumatologist on 17 July 2001. On the referral form completed by the vaccinee he indicated that he had experienced back, hip and knee pain for five years. He indicated that the given diagnosis for the pain was "stenosis". At the time of evaluation, the vaccinee was receiving clarithromycin and hydroxychloroquine therapy. "(The vaccinee) reports that since beginning on this treatment, he has had an increase in joint pain which has become more severe, but he claims that from what he reviewed on the Internet and in the medical literature that his is typical of people being treated for Lyme diseas... He reports that his social activity has declined dramatically." The rheumatologist noted that the vaccinee's father had arthritis and gout. On examination, "Musculoskeletal exam fails to reveal any synovitis in hi hands... He has good ROM (range of motion) at the wrists, elbows, and shoulders. Some stiffness with rotation at the bips, and discomfort with passive ROM at the shoulders, hips and knees. However he does not have any restricted ROM of any joints. There is no synovitis or joint effusions. He also has some tender points at the elbows, the shoulders, the paracervical and trapezius muscles, the lumbar region and hips. He occasionally experiences blurring of vision, nausea, lightheadedness, and hand tremors. Ongoing symptoms include fatigue, arthralgias, with an increased amount in the hips and back, myalgias, painful bumps in his scalp, tinnitus, headaches, muscle spasms, numbness of his hands and feet, a crawling sensation of his skin, short memory loss, and mood swings. The vaccinee returned to the second neurologist on 28 January 2002. At that time, the vaccinee described continuing multifocal problems including back pain radiating down to the right lower extremity. He remained on treatment for Lyme disease. On physical examination, the physician noted "good strength in both lower extremities. Sensory examination reveals an L5-S1 deficit to pinprick on the right. Reflexes symmetrical at 2/4 throughout except for the ankle jerks which were graded as trace positive bilaterally. Toes showed bilateral flexor plantar responses. Straight leg raising is limited bilaterally." The physician's impression was: "He continues to demonstrate neuropathic changes in the right lower extremity in an L5-S1 distribution. There does not appear to be any evidence of active denervation at this time. Nerve conduction parameters are within normal limits." The vaccinee was seen by the third rheumatologist on 25 February 2002 for follow-up of chronic arthralgias. " He continues to be quite limited in his activities of daily living. He suffers from chronic fatigue, chronic joint complaints and occasional joint swelling. At times he feels that there is swelling in his knees as well as hands. he finds that he is quite limited in his funcitonal activities being able to life or carry no more than 5 pounds. He has difficulty and limitations to bending, squatting or climbing stairs. He is unable to be on his feet for more than an hour at a time before he must sit and rest. He has tender points at the elbows, shoulders, throughout the spins especially the lumbar region, hips and knees. He has marked stiffness with flexion and rotation at the hips which is restricted by 50%. The most recent information, received 23 August 2002, indicated that the vaccinee continued to be treated for Lyme disease and continued to experience back pain and right leg symptoms as of 28 January 2002. Informaiton received 25 July 2002 indicated that the fibromyalgia persisted as of 25 February 2002. As of 03 January 2002, the vaccinee was still able to work. However, because the vaccinee reported that he was "becoming disabled", the activation of chronic Lyme disease and fibromyalgia are considered disabling. Y Y N 02/28/1996 Lyme IGM-negative (10/31/1995/11/28/1995); Creatine phosphokinase serum-219IU/L; rheumatoid factor-negative; Babesia IgG by IFA,16; babesia IgM by IFA <20; HGE antibody screen <1:64; HME IgG <1:64; Lyme IgG negative; x-ray right hand 01/17/01-probably old injury of the radial styloid; technetium bone scan-sternoclavicular and acromioclavicular degenerative changes, possible arthritic changes involving the hands bilaterally. EMG/nerve conduction studies, 28 January 2002, "Summary/Interpretation: Electrodiagnostic testing of the lower extremities continues to reveal an L5-S1 radiculitis, w/o (without) active denervation. Ncs (nerve conduction studies) are WNL (within normal limits." PVT PVT Ventolin, Allegra, Aspirin, Flovent, Lansoprazole UNK Asthma, allergic rhinitis, allergy to dust, gastroesophageal reflux disease, mononucleosis, lyme disease, allergy to grass and ragweed, chronic bronchitis, chronic sinusitis, fatty liver infiltration, hemorrhoids, hypertension, otitis media, premature ventricular contraction, tobacco use, ulcerative colitis. Medical history included mononucleosis (1970), vertigo, degenerative joint disease. 2001003260 1
0165813 02/13/2001 PA 55.0 M 02/09/2001 After an unspecified dose of Lymerix, the pt became extremely ill with among other symptoms severe joint and back pain. Reportedly at a physician's recommendation, the pt underwent coccygectomy in 9/99. This surgery reported was ineffective and directly resulted in an osteomyelitis infection. As of 2/1/01, the outcome of the events is unknown. Y U 05/01/1999 OTH OTH 20010034091 1
0165814 02/13/2001 61.0 61 M 11/26/2002 Report 2001003273-1 describes pain in an adult (age not provided) who received an injection of Lyme disease vaccine (Lymerix). This report was received from news service reports and has not been verified by a physician or other health care professional. The pt has tested (+) (NOS) for HLA-DR4. The pt received the 1st and 2nd doses of Lymerix on 4/13/00 and 5/11/00. At some later, unspecified time, he experienced intense pain, the site where the pain occurred was not specified. The patient's spouse stated "everything that's part of your day to day functioning is taken away from you." This report is considered SB medically serious because the patient reportedly could not perform his usual day-to-day functions. The report did not provide the outcome of this event. Follow-up dx: chronic inflammatory demylinating polyneuropathy. He underwent bi-weekly plasmapheresis. He also developed "a lot of atrophy, insulin dependence, depression, yeast infections, compression fractures, edema and tremors". As of 1/31/01, the pt was able to walk with a walker and is now profoundly disabled. Follow-up, states that in 7/00, he began to experience neurological symptoms and weakness. The pt was hospitalized for 5 days, then discharged for outpt physical therapy. He continued to grow weaker. His spouse stated that, "in September, when he was not responding, but continuing to deteriorate" the dx was changed from Guillain-Barre syndrome to chronic inflammatory demyelinating polyneuropathy. The pt was hospitalized for 9 days and underwent bi-weekly plasmapharesis. He continued to deteriorate. Within a 6 month period, he was hospitalized a total of 4 times. He received a total of 25 plasmapharesis treatments. He reportedly experienced intense pain; the site where the pain occurred was not specified. He also developed "a lot of atrophy, insulin dependence, depression, yeast infections, compression fractures, edema, tremors". Information received from the pt's spouse on 2/23/01, states that as of 1/31/01, the pt was able to walk with the assisstance of a walker. The pt's spouse stated that the pt "is now profoundly disabled". The report did not provide the outcome of the pain, atrophy, edema or tremors. The most recent information was received on 7/11/01 from an article posted on the internet. This article did not provide an outcome for any of the reported events. The pt had a history of non-insulin dependent diabetes mellitus since 1995. Pharmacy records from 1998 through 02/10/2002 indicates that he received two vials of human regular insulin, one on 12/21/2000 and one on 03/22/2001. The pharmacy records also indicated that he received mystatis suspension on 12/05/2000 and 01/09/2001. The pt was seen by a neurologist on 11/20/2000 "for an additional opinion concerning a polyneuropathy. The pt dates the onset of his problem to July and August of this year. On 05/11 and then again about one month later he received the LYMErix vaccine, which he tolerated well. However, in mid July he became aware of pain radiating downt the right leg reminiscent of the sciatica he had previously, over the next month or so he developed progressive tingling, numbness and weakness in all four limbs. On August 11 he fell twice at home and was seen the following day. An EMG wsa consistent with a demyelinating polyneuropathy. He was admitted to a hospital, diagnosed as having Guillain Barre and admitted to the intensive care unit. He received IV immunoglobulin on four occasions and seemed to plateau. On 08/17 he was sent home with physical therapy. Over the following month he seemed to become weaker. On 09/19 he ws seen by a physician who felt a more appropriate diagnosis would be CIDP and recommended steroids. The following day he was seen by another physician and was admitted to another hospital where he had plasmapheresis x 5 and was started on prednisone 30 mg daily, which he has been on up until now. At the time he was put on Prilosec prophlactically additional cycle. Since then he had additional plasmaphareses between 10/13 and 27. he is currently in the middle of an additional cycle, having had one pharesis on 11/13. He finds that within two weeks of the pheresis he starts to have increasing paresthesias and weakness. He was treated with Neurontin 900 mg at one point, which did not seem to have much impact. He has had no sphinetor difficulty or bulbar trouble. He also has had paresthesias on the anterior chest from the anterior axillary line to the midline, from about his low thoracic level down and not above that area. He had noticed increased tramulousness with this illness. He has had some pedal edema on the steroids as well as a lot of atrophy." The neurologist stated that review of systems was "notable for decreasing hearing, which he relates to noise exposure, with tinnitus, particularly in the right ear." The pt takes occasional diasepen for sleep." On physical examinations, he appeared "cushingpoid. VIII is cedreased bilaterally. He has mild dysmetria on finger to nose with eyes closed, but not with eyes opened. Heel knee shin is accurate but limited by weakness. There is hand interosseous wasting. There is substantial diminution of vibratory and temperature perception to the knees, mild in the fingersn and diminished temperature perception on the anterior abdominal and chest wall. He is areflexic, flanteux withdraw bilaterally. He cannot walk, but can transfer from wheelchair to examining table." The neurologist reviewed prior diagnostic evaluations and noted cerebrospinal fluid protein 125 mg/dL in August 2000. An EMG "demonstrated multi-focal demyelination with mild distal prolongation and no clear conduction block." The neurologist's impression was "The pt probably does have CIDP. The possible relation to LYMErix vaccine is interesting, but perhaps coincidental. At this point, his weakness appears to be a combination both of his underlying neuropathy and his steroid use." The neurologist decreased the prednisone dosage to 70 mg daily. Serum protein electrophoresis performed on 12/08/2000 revealed hypogammaglobulinemia. No monoclonal band was identified on immunofixation. The pt underwent magnetic resonance imaging of the lumbar spine, with contrast, on 12/19/2000. The radiologists impressions were "In comparisonto a screening evaluation of the lumbar spine obtained on 08/13/2000, there is a new finding of milc compression deformity of the superior and plate of T12 and more subtly involving the anterosuperior end plate of Ld. Associated band-like signal abnormality is suggestive of a non-specific marrow edema pattern. There is diffuse lumbar spondylosis which is not significantly changed form the prior examination. There is straightening of the normal lumbar lordosis. There is no abnormal enhancement ot suggest an infectious or inflammatory process. Specifically, there is no evidence for thickening or abnormal enhancement of the nerve roots." The pt was seen by the neurologist on 12/20/2000, after having his fifth pheresis session that morning. "The pt is minimally stronger in his upper extremities after the pheresis, but feels better overall. He recently has ha dcompression fractures at two levels in the back. I encouraged him to take calcium and vitamin D. He is developing a lot of pedal edema and I suggested he start on Dyazide twice a day for three or four days." The neurologist noted that the pt had been taking prednisone 50 mg daily for the previous two weeks. The neurologist lowered the dosage to 50 mg daily. Lyme nerology performed on 12/22/2000 was non-reactive. The pt returned to the neurologist on 03/27/2001. At that time, he was receiving plasmapheresis on Monday, Wednesday, and Friday approximately every six weeks. Medications included prednisone 30 mg alternating with 20 mg, calcium, vitamin D, dyazide one capsule twice daily, and Neurontin 300 mg three times daily. The neurologist noted, "He does have some leg restlessness at night with a lot of cramping. However, he has been getting increasingly active doing multiple chores around the house, gardening, and exercising. He is able to lift eight pounds. He has noticed continued easy bruising and bleeding. He continues to have severe tingling in hands and feet, which he finds quite distracting. On exam he is able to walk, which he could not do previously. He is just barely able to rise on toes. He can walk a few steps with the toes lifted off the ground. There is marked diminution of vibratory sense at the great toe, mild to moderate at the ankles. He is aroflexic. He has a mild foot drop on walking, but he is able to compensate for this." The neurologist's impression was "The pt is doing much better. He continues to have some steroids related side effects." The neuralogist reduced the prednisone dosage to 30 mg alternating with 10 mg, asked the pt to reduce plasmapheresis to two times every six weeks, and increased the Neurontin dosage. The pt returned to the neurologist on 05/22/2001. "He generally is doing well. He is now able to walk and finds his hands have improved significantly. He has a dull sensation in the hands, tingling and paresthesias in the calves and feet and occasional shooting pain in the feet." On examination, "He does walk with a waddling gait and a tendency to a foot drop,but he is able to walk clearing the floor with his toes or walk on his heels. He is areflexic. There is significant less of vibratory sense at the left great toe and ankle, as well as the right great toe. Sensation at the right ankle is almost normal." The neurologist reduced the prednisone dosage to 30 mg alternating with 0 mg, and increased the neurontin dosage to 300 mg three times daily. The pt was seen by the neurologist on 08/02/2001. "He has been doing quite well, although he stillneeds plasmapheresis at roughly four weeks intervals. His strength overall is improving steadily. he notes a lot of numbness and pins and needles paresthesias in the feet, as well as occasional lancinating pain. He has been diagnosed as having rheumatoid arthritis." The pt was seen by neurologist on 10/16/2001. "He feels he has been doing well. On his last visit I started him on Klavil 25 g. He now sleeps soundly and is relatively pain free until about noon." The most recent report info received on 02/19/2002, indicated that the chronic inflammatory demyelinating polyneuropathy had improved "substantially," but persisted as of 12/18/2001. Foot discomfort also persisted. Pharmacy records indicated that the pt had not received insulin for 11 months. He had not received treatment for yeast infectons for 13 months. The outcomes of the atrophy, depresion, compressionfractures, and edema were not specified. The most recent info, received on 03/22/2002, indicated that leg pain, weakness, loss of function, and decreased sensation persisted as of 02/13/2002. The follow-up states that there were no known drug allergies. To the vaccinee's knowledge, there was no family history of Parkinson's disease, Alsheimer's disease, motor neuron disease, myasthenia gravis, multiple sclerosis, neuromuscular diseases, thyroid disease, lupus or rheumatoid arthritis. On 04/03/2002, medical records were received from a neurologist at a care center, who evaluated the vaccinee as on unspecified date. This neurologist indicated thatt he vaccinee "is seeing me as a second opinion. In mid-July 2000, the pt awoke with low back pain. He says that several days later he noted that there was tingling and cold in his feet and the back pain continued. He noted the onset of floppiness of his feet, right being worse than left. He says that this followed in mid-August by tingling in his hands. He fell several times about 08/12/2000 and was seen by a neurologist. He was hospitalized, and the diagnosis of Guillain Barre was made and was given intravenous immunoglobulin. The pt states that the numbness in the feet gradually spread proximally to the knees over approximately a week. This then ascended to the hip level after a following week and after that, it went up to the mid-abdominal level. There was weakness gradually progressive in teh legs, and he had problems arising from the toilet and getting out of a sofa. Following the intravenous immunoglobulin, he was no worse although he did not notice any improvement. He began to use a walker at that time for ambulation. He has had rehabilitation, however, the tingling and weakness have remained about the same, but he thinks perhaps they may have actually worsened. Despite the rehab, his strength has lessened especially in his legs and his endurance has gotten significantly worse. He also has ha dproblems with grip strength which may have improved with exercise although he is not clear about this. The leg strength he believes is clearly worse. The pt denies problems with bowel or bladder functions, and he has been quite depressed. He uses Serzone 200 mg per day for the depression." Later in the document, the neurologist listed the nefazodone dosage as 200 mg twice daily. The neurologist wrote, "on neurological examination, the mental status shows an emotional lability and anxiety. He is otherwise normal. On motor examinations, there is weakenss of the back flemors and extensors. There is also some ataxia noted on finger-nose-figner testing, however, it is even hard for him to hold his arms up therefore making the ataxia testing somewhat unreliable. Rapid alternating movements as judged by finger tapping is normal, and toe tapping is relatively normal though limited by weakness. The range of motion is markedly decreased because of weakness. The gait shows bilateral foot drops, and the pt uses a walker, and he has problems with back support and seems to be falling somewhat forward. The pt is unalbe to tendon walk as he needs a walker, and he has na unsteady gait and some tremor which is probably related to his weakness. There are Habinski sings noted, and the deep tendon reflexes are absent throughout. There is decreased vibration in soft tissue up to the thighs and to the wrists soft tissue. Pin and cold are normal. Proprioception is decreased in the fingers and abnormal to the level of the ankles. There are after sensations noted to the mid-shin level and also to the level of the wrists. On muscle strength testing, there is moderate weakness proximally and somewhat more exaggerated distally although this is somewhat spotty in the upper extremities. They are relatively symmetrical in the lower extremities. The weakness, again is more proximally although it is somewhat spotty. The worst areas appear to be the hip flaxors which are 3 to 4/5 bilaterally and also the finger and wrsit extensors which again are -4. The ankle dorsiflexors are also -4 as are the knee flexors and extensors. There are no fasciculations noted, and there is no atrophy noted. The reflexes are absent throughout. Neck flexion is weak as is extension although this is only mild. The facial muscles are normal strength. The impression is that the pt has CIDF or chronic inflammatory demyelinaitng polyradiculoneuropathy. On 04/03/2002, did not provide the outcome or the reported events. The pt was evaluated at a pain management center on 11/16/2001. Medications at that time included prednisone 15 mg every other day, Glucotrol XL 10 mg daily. Actos 30 mg daily, Celexa 30 mg twice daily, Prinivil 5 mg daily, neurontin 800 mg daily, Dyaside once daily, Mumulin R sliding scale as needed, desipramine 10 mg daily, anitriptyline 25 mg daily, multivitamin and mineral supplement, vitamin E, and calcium carbonate. The pain psecialist's impression was "painful polyneuropathy secondary to a number of otiologics including his history of diabetes and CIDP." The physician recommended discontinuation of desipramine, tapering of Neurontin until it was discontinued, increasing the amitriptyline dossage to 50 mg at night, consolidation of antidepressant medications and the application of lidocaine patches to the soles of both foot two to four times daily. On 12/19/2001, the pain specialist recommended tha tLidodern patches tbe applied at night and that lidocaine/prilocaine cream be applied to the soles and dorsol aspects of the feet four times daily. The amitriptyline dosage was increased to 75mg daily at bedtime. The vaccinee returned to the pain specialist on 03/06/2002. The pt reported that "raising his amitriptyline dosage to 75 mg only made him sleepy without any additional benefit from a pain control point of view. Therefore, I am going to start him on Lamictal 25 mg twice daily." The pt was to take amitriptyline 50mg daily at bedtime. The most recent info received on 04/11/2002, indicated that painful polyneuropathy persisted as of 03/04/2002. Info received on 03/22/2002 indicated that leg pain, weakness, loss of function, and decreased sensation persisted as of 02/13/2002. Of the thoracic spine MRI, the radiologist wrote, " Screening thoracic spine MRI shows no evidence of cord compression or central spinal stenosis. No definite focal disc herniation is identified. There are degenerative disc changes." Of the lumber spine MRI, the radiologist wrote, "Screening lumber spine examination shows diffuse lumbar spaadylosis, most marked at the L4-5 and L5-S1 levels, where there may be mild central spinal stenosis. There are diffuse degenerative disc changes. No definite focal disc herniation is identified." Bilateral sensorineural hearing loss, that was "mild sloping to severe" (01/25/1999) and palmar fasciectomy of the right palm and ring finger(1999). The most recent info, received 05/28/02, did not specify the outcome of the reported events. On 08/24/01, the pt was seen by the pediatrist for a chief complaint of thick and elongated toenails. His current medications included prednisone, Glucotrol, Actos, Celexa, Prinivil, dyazide, Neurontin, Humulin and Fosamax. The pt was not physically active. The neurologic examination revealed diminished sharp/dull and two-point discrimination, but the pt does have 5.07 monofilament wire sense. pt had cavus foot type with rearfoot valgus noted upon weight bearing. biomechanical examination revealed muscle strength testing was 5 out of 5 in all cardinal planes. There were noted some contractures to all lesser digits of the right lower extremity. X-ray examination revealed severe degenerative joint disease to the first metatarsophalangeal joint and the proximal interphalangeal joint of the hallux noted bilaterally. The impression was diabetes mellitus and anychomyocosis. The pt's nails were debrided. *Follow-up report on 10/10/02: The vaccinee was evaluated by an oncologist/hematologist on 9/26/01 "regarding a possible monoclonal gammopathy". The MD stated that serum protein clactrophoresis and immunoclectrophoresis were performed in July 01, and "revealed the presence of an IgG lambda gammopathy. IgG was 337, IgA 113, and IgM 94. I saw him in consultation on Sept. 26, 01. He felt well. Paresthesias in his feet persisted. He noted no fever, swollen glands, abdominal pain, weight loss, nor night sweats. He has had chronic low back pain due to vertebral compression fractures. He stated he is pherosod once per month. His last pherosis was 3 weeks previously." The MD noted that the vaccinee's "medical history was notable for... rheumatoid arthritis (but his rheumatoid factor is negative)." Medications included prednisone 20 mg every other day, glipizide (Glucotrol XL), pioglitazone (Actos), citalopram (Celexa), lisinopril (Prinivil), gabapentin (Neurontin), triamtorone/ hydrochlorethieside (Dryside), regular human insulin (Rumulin R), naproxan (Neprosyn), alendronate (Posamax), amitriptyline, multivitamin, vitamin E, bioflavinoids/ vitamin C (Ester? C), mathyloebalamino, calcium carbonate/ cholecalciferol (OsCal 500 + D), and ferrous sulfate (slowFe). Serum protein electrophoresis and serum protein immunoelectrophoresis were repeated. The MD stated, "I could not confirm the presence of monoclonal gammopathy upon re-evaluation in [the facility's] lab. His IgG level is minimally depressed. This may well be related to his steroid therapy and pharesis." On 10/11/01, a variety of merologies for Lyme disease were performed. The lab's overall interpretation was "no evidence of seroreactivity beyond that expected from Lyme vax." The PT was seen by the 2nd neurologist on 10/16/01. "He feels he has been doing well. On his last visit I started him on Elavil (amitriptyline) 25 q hs [at bedtime]. He now sleeps soundly and is relatively pain free until about noon." Other medications included prednisone 20 mg every other day, Neurontin 800 mg twice daily, and Dyazide. The PT "has been able to stretch his pheresis to every 5 wks. However, by that point he had developed a lot of pain, tingling and progressive weakness." On exam, he was able to walk on heels and toes, as well as, tandem. "Romberg is quite unsteady." The neurologist reduced the prednisone dosage to 15 mg every other day, reduced the Neurontin dosage to 400 mg twice daily, and added nortriptyline (Pamelor) 10 mg at mid-day. On 11/16/01 the vaccinee was seen by a 2nd rheumatologist. The rheumatologist reported that the PT's complaint was "diffuse joint pains" (this event was not reported as an adverse event due to vax admin, but was found during the course of review of the vaccinee's medical records). The PT had informed the rheumatologist that "this has been going on for approx 1-1.5 yrs and had started in his kness, hands, and feet". The PT had seen another rheumatologist who Dx'd him w/"possible rheumatoid arthritis and concomitant osteoarthritis". The other rheumatologist had "treated him w/delecoxib (Celebrex) which was not helpful and then was treated w/prednisone which did help to some degree. The MD exam revealed "a fair appearing male w/a slow gait". Exam of the "KEENT" was unremarkable. His visit showed pain w/flexion and palpation. There was slight arepitus of the knees. The feet revealed some downward protrusion of the matatersal heads. Lab data included a negative rheumatoid factor, normal C-reactive protein (CRP) and sedimentation rate." The rheumatologist believed "this PT has multifactorial pain. There is some degree of osteoarthritis, particularly in the knees. His neuropathic disease is also contributing, but there seems to be no evidence of an inflammatory connective tissue disease. At this time, I would recommend continued pain control w/his Neurontin as well as tricyclics. He is also on prednisone 15 mg every other day, which does seem to be helping. He should, or course, continue the Focamax to prevent steroid-induced osteoperosis". The rheumatologist requested that he return approximately 2 mts to follow up on his pain. The PT was evaluated at a pain management center on 11/16/01. Medications at that time included prednisone 15 mg every other day, Glucotrol XL 10 mg daily, Actos 10 mg daily, ditalopram (Celexa) 30 mg twice daily (initiated by the PT's internist for the treatment of depression). Prinivil 5 mg daily, Neurontin 800 mg daily, Dyaride once dailly, Kumulin R sliding scale s needed, desipramine 10 mg daily, amitriptyline 25 mg daily, multivitamin and mineral supplement, vitamin E, and oslolum carbonato. The pain specialist's impression was "Painful polyneuropathy secondary to a number of etiologies including his history of diabetes and CIDF." The MD recommended discontinuation of dosipramine, tapering of Neurontin until it was discontinued, increasing the amitriptyline dosage to 50 mg at night, consolidation of antidepressant medications, and the application of lidocaine (Lidoderm) patches to the soles of both feet two to 4 times daily. The PT returned to the 2nd neurologist on 12/18/01. "He has been on 15 mg of prednisone every other day since Oct. and has been getting 3 pharceci 6 wks which he has tolerated well. He feels he is steadily improving. Last Christmas he was in a wheelchair. He is now quite ambulatory. He still has considerable foot discomfort... He was tried on a lidocaine patch, but he finds this bunches up in his shoes and is awkward to use. The Flavil? was doubled from 25 to 50 mg at night which he has tolerated, but it has not yet had an impact on his Sx's. He continues on Neurontin 800 mg daily... On sensory testing there is a significant loss of temperature perception to mid calf, a little worse in the right leg than the left. There is a marked, but incomplete loss of vibratory perception at the great toe bilaterally, mild to moderate at the ankles. Upper extremity reflexes are 1+ and symmetric, as are knee jerks. Ankle jerks are absent. Plantars are flexor. He is able to walk on heels and toes. Hamberg is quite unsteady. IMPRESSION & PLAN: The PT is doing substantially better than he was previously. He will drop his prednisone to 12 mg every other day and plan to drop it to 10 mg in about 4 wks. He will drop his Neurontin to 400 mg daily for the next week or 2. If his Sxs are no worse, he will continue to taper it off." On 12/19/01, the pain specialist recommended that Lidoderm patches he applies at night, and that lidocaine/prilocaine cream (EMLA cream) be applied to the soles and dorsal aspects of the feet four times daily during the day. The amitriptyline dosage was increased to 75 mg daily at bedtime. The vaccinee underwent physical therapy evaluation on 2/12/02. The vaccinee reported that "He received therapy last yr for strengthening and conditioning and was feeling better. He is currently ambulating around the house in short distances w/out assisted device. However, he does use a walker for outside or long term walking. His chief complaint is that of constant pain in the legs, weakness and loss of function. He states he has decreased sensation which gets worse distally. He cannot feel the bottom of his feet." The vaccinee was to receive physical therapy 3 times / week for 6-8 wks to "Increase flexibility, increase strength, increase endurance." The vaccinee stopped going to physical therapy after 7 sessions. The vaccinee returned to the pain specialist on 3/6/02. The PT reported that "Raising his amnitriptyline? dosage to 75 mg only made him sleepy w/out any add'l benefit from a pain control point of view. Therefore, I am going to start him on Lamictal [lamotrigine] 25 mg twice daily." The PT was to also take amitriptyline 50 mg daily at bedtime. Pharmacy records indicate that the PT was also treated w/zolpidem (Ambien) and taleplon (Sonata). On 4/3/02, medical records were received from a neurologist at a tertiary care center, who evaluated the vaccinee on an unspec'd date. This neurologist indicated that the vaccinee "is seeing me as a 2nd opinion. In mid-July 00, the PT awoke w/low back pain. He says that several days later he noted that there was tingling and cold in his feet and the back pain continued. He noted that onset of floppiness on his feet, right being worse than left. He says that this followed in mid-August by tingling in his hands. He fell severall times about 8/12/00 and was seen by a neurologist. He was hospitalized, and the Dx of Quillain-Barre was made and was given intravenous immunoglobulin... The PT states that the numbness in the feet gradually spread proximally to the knees over approx a week. This then ascended to the hip level after a following week, and after that, it went up to the mid-abdominal level. There was weakness gradually progressive in the legs, and he had prob's arising from the toilet and getting out of a sofa. Following the intravenous immunoglobulin, he was no worse although he did no notice any improvement. He began to use a walker at that time for ambulation. He has had rehab, however, the tingling and weakness have remained about the same, but he thinks perhaps they may have actually worsened. Despite the rehab, his strength has lessened especially in his legs and his endurance has gotten significantly worse. He also has had prob's w/grip strength which may have improved w/exercise although he is not clear about this. The leg strength he believes is clearly worse. The PT denies prob's w/bowel or bladder function, and he has been quite depressed. He uses Serzone [nafazadone] 200 mg per day for the depression." Later in the document, the neurologist listed the nefazadone dosage as 200 mg twice daily. Other medications at the time of the evaluation included naproxen 500 mg twice daily, omeprazole 20 mg daily, gabapantin 400 mg three times daily, amlodipino 5 mg twice daily, glipizide 10 mg daily, and lisinopril 5 mg daily. The neurologist wrote, "On neurological exam, the mental status shows an emotional lability and anxiety. He is otherwise normal... On motor examination, there is weakness of the neck flexors and extensors. There is also some staxia noted on finger-nose-finger treating, however it is even hard for him to hold his arms up therefore making the ataxis testing somewhat unreliable. Rapid alternating movements as judged by finger tapping is normal, and toe tapping is relatively normal though limited by weakness. The range of motion is markedly decreased because of weakness. The gait shows bilateral foot drops, and the PT uses a walker, and he has prob's w/back support and seems to be falling somewhat forward. The PT is unable to tandem walk as he needs a walker, and he has an unsteady gait and some tremor which is probably related to his weakness. There are Babinski signs noted, and the deep tendon reflexes are absent throughout. There is decreased vibration in soft tissue up to the thighs and to the wrists soft tissue. Pin and cold are normal. Proprioception is decreased in the fingers and abnormal to the level of the ankles. There are alter sensations noted to the mid-shin level and also to the level of the wrists. On muscle strength testing, there is moderate weakness proximally and somewhat more exaggerated distally although this is somewhat spotty in the upper extremities. They are relatively symmetrical in the lower extremities. The weakness, again, is more proximally although it is somewhat spotty. The worst areas appear to be the hip flexors which are 3 to -4/5 bilaterally and also the finger and wrist extensors which, again, are -4. The ankle dorsiflexors are also -4 as are the knee flexors and extensors. There are no fasciculations noted, and there is no atrophy noted. The reflexes are absent throughout. Neck flexion is weak as ix extension although this is only mild. The facial muscles are normal strength. The impression is that the PT has CIDP or chronic inflammatory damyelinating polyradiouloneuropathy." On 5/17/02, the PT was seen by the pediatrist. The PT c/o'd of "blueness of right leg" and was sent for vascular evaluation "as soon as possible." The most recent info, received 9/24/02, did not specify the outcome of the reported events. Info. received on 4/11/01 indicated that painful polyneuropathy persisted as of 3/6/02. Info received on 3/22/02 indicated that leg pain, weakness, loss of function, and decreased sensation persisted as of 2/13/02. Info received from the PT's spouse on 2/23/01 indicated that, as of 1/31/01, the PT was "profoundly disabled." Info received on 2/19/02 indicated that the chronic inflammatory demyalinating polyneuropathy had improved "substantially", but persisted as of 12/18/01. Pharmacy records indicated that the PT had not received insulin for 11 mts. He had not received treatment for yeast infections for 13 mts. The most recent info, received on 10/1/03, indicated that the pt was "stable" and "has very little pain" as of 3/6/03. Information received from the pt's spouse on 2/23/01 indicted that, as of 1/31/01, the pt was "profoundly disabled." Pharmacy records indicated that the pt had not received insulin for 11 months. He had not received treatment for yeast infections for 13 months. Report 2001003273-1 describes chronic inflammatory demyelinating polyneuropathy in 60-year-old male who received from news service reports, the patient's spouse, and as part of lit Y Y N 05/11/2000 07/01/2000 51 Albumin, CSF, 8/14/00, result - 79.8 mg/dL, range <or=27.0; Albumin, Serum, 12/8/00, 3.2 g/dL, 3.3-4.4; Albumin, Serum, 9/26/01, 4.5 g/dL, 3.3-4.4; Albumin/Globulin ration, 12/8/00, result - 1.5; Albumin/Globulin ration, 9/26/01, result - 1.7; Alkaline Phosphatase, Serum, 7/27/01, result - 40 IU/L, range 45-177; Alpha 1 globulin, 12/8/00, result - 0.2 g/dL, range 0.1-0.3; Alpha 1 globulin, 9/26/01, result - 0.2 g/dL, range 0.1-0.3; Alpha 2 globulin, 12/8/00, result - 0.9 g/dL, range 0.6-1.0; Alpha 2 globulin, 9/26/01, result - 0.8 g/dL, range 0.6-1.0; Angiotension 1 converting enzy, 12/8/00, result - 12.9 U/L, range 8.0-52.0; Antinuclear antibody, 8/12/00, result <1:40; Antinuclear antibody, 12/8/00, result 1:40, range <1:40; Antinuclear antibody, 8/12/00, result Nuclesolar; Antinuclear antibody, 1/25/01, result Neg; Beta globulin, 12/8/00, result 0.9 g/dL, range 0.5-1.1; Beta globulin, 9/26/01, result 1.1 g/dL, range 0.6-1.1; C-Reactive Protein, Serum, 7/12/00, result 0.1 mg/dL, range 0-0.8; C-Reactive Protein, Serum, 8/11/00, result 0.2 mg/dL, range 0-0.8; C-Reactive Protein, Serum, 7/3/01, result 2.0 mg/dL, range 0-4.9; C-Reactive Protein, Serum, 11/15/01, result 0.6 mg/dL, range 0-0.9; CAQ Complex, 12/8/00, result <or= 37mcg/mL Eq, range <or=37; C?D IgG, 12/8/00, result <15 mcg/mL Eq, range <15; CMV IgG, 8/12/00, result - Pos; CMV Antibody index, 8/12/00, result 48; CSP IgG, 8/14/00, result 13.2 mg/dL, range <or=8.1; CSP IgG index, 8/14/00, result 0.34, range <or=0.85; CSF glucose, 8/12/00, result 99 mg/dL; CSF glucose, 1/25/01, result 123mg/dL, range 40-80; CSF protein, 8/1/00, result 125mg/dL; CSF protein, 8/12/00, result 125mg/dL; CSF protein, 1/25/01, result 188.2 mg/dL, range 15.0-45.0; Crynoglobulins, 12/8/00, result Neg; Double-stranded DNA antibody, 7/3/01, result Neg; Erythrocyte Sedimentation rate, 4/7/00, result 4 mm/hr, range 0-10; Erythrocyte Sedimentation rate, 7/28/00, result 8 mm/hr, range 0-10; Erythrocyte Sedimentation rate, 7/3/00, result 1 mm/hr, range 0-10; Erythrocyte Sedimentation rate, 11/16/01, result 15 mm/hr, range 0-20; Gamma Globulin, 12/8/00, result 0.3 g/dL, range 0.7-1.7; Gamma Globulin, 9/26/01, result 0.6 g/dL, range 0.7-1.7; Globulin, 9/26/01, result 2.7 g/dL; Glucose, Blood (fasting?), 11/17/00, result 322 mg/dL, range 650110; Glucose, Urine, 7/3/00, result 2+, Range - Negative; Haematocrit (Packed Cell Vol), 1/26/01, result 27.0%, range 42.0-52.0; Haemoglobin, 1/25/01, result 9.7 g/dL, range 14.0-18.0; Haemoglobin, 1/25/01, result 10.4 g/dL, range 14.0-18.0; Haemoglobin, 1/26/01, result 9.0 g/dL, range 14.0-18.0; IgG, S, 8/14/00, result 1920 mg/dL, range 700-1500; IgG/Albumin, CSF, 8/14/00, result 0.17, range <or=0.21; IgG/Albumin, S, 8/14/00, result 0.49, range <or=0.4; Immunoglobulin A, Serum, 8/11/00, result <1, range <1.0; Immunoglobulin A, Serum, 12/8/00, result 150 mg/dL, range 68-378; Immunoglobulin A, Serum, 7/1/01, result 113 mg/dL; Immunoglobulin A, Serum, 7/9/01, result 63 mg/dL, range 70-400; Immunoglobulin A, Serum, 9/26/01, result 167 mg/dL, range 68-378; Immunoglobulin G, Serum, 8/11/00, result <1, range <1.0; Immunoglobulin G, Serum, 12/8/00, result 215 mg/dL, range 694-1618; Immunoglobulin G, Serum, 7/1/01, result 337 mg/dL; Immunoglobulin G, Serum, 7/3/01, result 222 mg/dL, range 700-1600; Immunoglobulin G, Serum, 7/17/01, result 337 mg/dL, range 700-1600; Immunoglobulin G, Serum, 9/26/01, result 466 mg/dL, range 698-1618; Immunoglobulin M, Serum, 8/11/01, result <1, range <1.0; Immunoglobulin M, Serum, 12/8/00, result 119 mg/dL, range 60-263; Immunoglobulin M, Serum, 7/1/01, result 94 mg/dL; Immunoglobulin M, Serum, 9/26/01, result 130 mg/dL, range 60-263; Kappa light chains, 12/8/00, result 252 mg/dL, range 374-1276; Kappa light chains, 9/26/01, result 437 g/dL, range 374-1276; Kappa/Lambda ratio, 12/8/00, result 1.65, range 1.48-2.58; Kappa/Lambda ratio, 12/8/00, result 1.78, range 1.48-2.58; Lactic Dehygrogonaso, Serum, 9/26/01, result 228 U/L, range 30-242; Lambda light chains, 12/8/00, result 152 mg/dL, range 269-638; Lambda light chains, 9/26/01, result 246 mg/dL, range 269-638; Lyme Serology Index, 8/12/00, result 0.94; Lyme antibody ELISA, 12/8/00, result Non-reactive; Lyme disease serology, 12/22/00, result Non-reactive; Mean Corpuscular Haemoglobin, 6/28/00, result 6.26 pg; Microalbumin, urine, 7/3/00, result Neg; Phosphate, serum, 7/3/01, result 4.3 mg/dL; Phospholipid IgG, 8/13/00, result 4.2 mg/dL; Phospholipid IgG, 8/13/00, result Neg; Phospholipid IgM, 8/13/00, result Neg; Polymorphonuclear neutrophils, 7/3/00, result 80%, range 40-74; Polymorphonuclear neutrophils, 7/17/01, result 81%, range 40-74; Protein, Serum, Total, 12/8/00, result 5.4 g/dL, range 6.0-8.5; Protein, Serum, Total, 1/25/01, result 4.7 g/dL, range 6.0-8.5; Protein, Serum, Total, 9/26/01, result 7.2 g/dL, range 6.0-8.5; PRP, 7/27/01, result Non-Reactive; PRP (DVRL), 8/11/00, result Non-Reactive; Red Blood Cell Count, 1/25/01, result 2.94x10~6/UL, range 4.70-6.10; Red Blood Cell Count, 1/26/01, result 2.85x10~6/UL, range 4.70-6.10; Rheumatoid factor, 8/11/00, result <20IU/mL, range <21; Rheumatoid factor, 12/8/00, result 7.31U/mL, range <16; Rheumatoid factor, 7/3/01, result 3.6IU/mL, range 0.0-13.9; Rheumatoid factor, 11/16/01, result 3.4IU/mL, range <16.0; Sjogran's SSA antibody, 7/3/01, result Neg; Sjogran's SSB antibody, 7/3/01, result Neg; Synthesis Rate, CSF, 8/14/00, result 0mg/24 h, range <or=12; Triclycerides, Serum, 4/9/01, result 341 mg/dL, range <200; Urea Nitrogen, Blood, 1/9/01, result 45mg/dL, range 6-26; Urea Nitrogen, Blood, 7/17/01, result 38mg/dL, range 5-26; Vitamin B12, 1/9/01, result 1908pg/mL, range 193-982; White Blood Cell Count, 7/3/00, result 13500/cu mm; range 4100-10900; White Blood Cell Count, 1/9/01, result 16100/cu mm; range 3680-11000; White Blood Cell Count, 7/3/01, result 13500/cu mm; range 4100-10900; Bone mineral density scan left hip, 4/27/00: "T score: No osteopenia"; Bone mineral density scan lumbar spine, 4/27/00: "T score: No osteopenia/ lumbar spine factors: osteo-arthritis"; Bone mineral density scan left hip, 7/30/01: "T score: No osteopenia"; Bone mineral density scan lumbar spine, 7/30/01: "T score: No osteopenia/ and lumbar spine factors: osteo-arthritis"; HMG and nerve conduction velocity studies, 8/12/00 - "Conclusions and Interpretation: Abnormal study. Findings are consistent w/moderate sensory motor symmetric demyelination > anonal polyneuropathy such as may be seen in Quillain Barre Syndrome."; EMG and nerve conduction studies. 12/11/00 - "Conclusion: This study is consistent w/severe sensory motor, axonal and demyelinating neuropathy. Features were both of an acute and chronic nature. Given the PT's history of possible CIDF, this study would be suggestive of this Dx, however, other atiologies of an acute and chronic sensory and motor neuropathy should also be considered. In comparison w/the Aug. 00 study the neuropathy has progressed substantially."; MRI cervical spine, 8/13/00 - "Impression: Screening cervical spine exam shows no evidence of cord compression or central spinal stenosis. There is cervical spondylosis and degenerative disc changes, but no definite fecal disc herniation."; thoractic spine, 8/13/00 - "Impression: Screening theracic spine MRI shows no evidence of cord compression or central spinal stenosis. No definite focal disc herniation is identified. There are degenerative disc changes."; MRI lumbar spine, 8/13/00 - "Impression: Screening lumbar spine exam shows diffuse lumbar spondylosis, most marked at the L4-5 and L5-S1 levels. Where there may be mild centraql spinal stenosis... There are diffuse degenerative disc changes. No definite focal disc herniation is identified."; MRI lumbar spine w/contrast, 12/19/00 - "Impression: 1) In comparison to a screening evaluation of the lumbar spine obtained on 8/13/00, there is a new finding of mild compression deformity of the superior and plate of T12 and more subtly involving the antercauperior and plate of L4. Associated band-like signal abnormality... is suggestive of a non-specific marrow edema pattern.. 2) There is diffuse lumbar spondylosis which is not significantly changed from the prior exam. There is mild central stenosis at Lc-5 but no evidence for compression of the thecal sac or existing nerve roots. 3) There is straightening of the normal lumbar lordosis. 4) There is no abnormal enhancement to suggest an infectious or inflammatory process. Specifically, there is no evidence for thickening or abnormal enhancement of the nerve roots."; MRI brain with and w/out contrast, 1/26/01 - "Impression - no evidence of cerebral or cerebellar infarction"; MRA head and neck, 1/26/01, "Impression - normal study"; CT head w/out contrast, 1/24/01, "Impression - involutional changes"; X-ray, 8/24/01, "Severe degenerative joint disease to the first metarsophalangeal joint and the proximal interphalangeal joint of the hallux noted bilaterally. There were no other fractures or dislocations noted." Microbiology acid-fast bacilli, 8/12/00, "No acid fast bacteria isolated"; Microbiology, 8/12/00, "Interpretation Cryptococcus AG CSF and Cryptosporidium ID - both negative. Coagulation - Myelin basic protein 3.4 ug/L Normal 0-4.0 interpretation - negative."; Cerebrospinal fluid cytology, 8/14/00, "Dx for malignant cells. Specimen consists of scant polymorphonuclear leukocytes and lymphocytes, in a background of amorphous material"; Lyme serology, 8/14/01, "Antibody Capture Enzyme Immunoassay - comments: No IgM, IgG or IgA antibody to B. burgorferi detected by capture EIA; the IgG immunoblot results fell w/in normal limits. Interpretation: the pattern of reactivity observed by immunoblot is consistent w/response to OspA Lyme vax. No serologic evidence of infection w/B. burgdorferi. Immunoblet (IgG) normal range: Reactivity to <5 antigens on each blot"; Lyme IgG ELISA, 10/11/01, <80 (normal <80); Lyme IgG Western blot, 10/11/01, Neg, zero bands present; Lyme IgM Western blot, 10/11/01, Neg, zero bands present; MarDx Western Blot IgG, Neg, zero bands present; Immunatics Western Blot IgG, Neg, 41 kD and 1 unidentified band present; "Overall interpretation: No evidence of seroreactivity beyond that expected from the Lyme vax"; SPEP, 12/8/00, "Interpretation - Hypogammaglobulinemia"; Serum immunofixation, 12/8/00, "No monoclonal band identified"; Serum immunofixation, 7/8/01, "Immunofixation Interpretation - PT patterns indicate an IgG lambda monoclonal gammopathy w/a suppression of IgA. Total protein decreased"; Serum immunofixation, 7/17/01, "Bands of restricted mobility noted in IgG and lambda"; SPEP, 9/26/01, "Interpretation - Normal electrophoresis pattern"; Serum immunofixation, 9/26/01, "No monoclonal band identified" OTH OTH Calcium salt, vitamin D, Trimaterene, Glipimoda, Pioglitarone, Liminopril, Anlodipine, Glucotrol XL, Actos, Prioivil, Prilosec, nanroxen, slendronate, busnirone, Viagra, cyanocobalamin, iron salt, vitamin E, multivitamin, Omaprosole, Naprox UNK HLA-DR4 (+) (NOS), non-insulin dependent diabetes mellitus, chest pain, atherosclarotic heart disease, arthritis of the right knee, dupovtren's contracture of the right hand, aciation, decreased hearing, tinnitus, positive tuberculosis skin test, basal cell carcinoma, actinic challitis, hyperplastic actinic keraposis wiht candidiasis, and macular keratosis, exposure to agricultural chemicals NOS, tonsillectomy, vasectomy, release of Dubuytren's contracture, cardiac dysfunction, coronary artery diseas, tobacco use and ischemia. 2001003273 1
0165815 02/13/2001 NJ 35.0 35 F 02/06/2001 Following the 2nd dose, the pt experienced flu like symptoms. Soon after that her knee became really swollen and had it drained 3 times, had 2 surgeries. After the 3rd shot, her problems really began. She developed auto immune arthritis reaction in her body. She had inflammation in her eye which was treated by a retina specialist. She was placed on prednisone. Y N 07/14/1999 07/15/1999 1 PVT UNK Claritin psoriasis allergy to aspirin, PCN 1
0165816 02/13/2001 WA 22.0 22 M 02/05/2001 The pt experienced joint pains to the left leg, left elbow, knees, wrists. The pt has muscle aches in left neck-shoulder area, nausea, headaches off and on, tired. Sometimes the joint pain is so bad, the pt had trouble sleeping. The pt has complained of numbness in arms upon waking. Follow up on 11/29/2001: "We do not maintain VA records at this facility. Diagnosis and treatment of adverse events that occurred following completion of Anthrax vaccine series 12/1998. PE, lab, diag tests, treatment, and outcome. " Y N 09/04/1998 12/01/1998 88 MIL MIL NONE NONE pain in knees, bursitis, tinnitus joint pains weakness, nausea, tiredness~Anthrax (no brand name)~6~24.00~In Patient 1
0165817 02/13/2001 IN 0.3 0 .2 M 02/07/2001 Four days post vax, the pt experienced bright green mucous stools. Two days after that the pt had blood in his green stool. The pt saw a physician on 12/18 and after several stool samples a diagnosis of allergic colitis was made. The pt has been placed on special formula, he could not tolerate breast milk. pER DOC 214441,Annual follow-up, patient continues to have allergies, green stools. Speech delays. Y Y U 11/28/2000 12/02/2000 4 stool culture, O+P - neg, PT and PTT - nml, Roto - neg, fecal leukocytes - many, CBC - nml, WBC - elevated PUB OTH Tylenol NONE NONE blood in stool~Hep B (no brand name)~1~0.00~In Patient 1
0165818 02/13/2001 IN 0.5 0 .5 F 02/05/2001 Abscess on right buttock, at injection site. Abscess drained and cultured on 1/13/01. Treated with Keflex; changed to Augmentin on 1/16/01. Abscess on left thigh drained and cultured and treated with Keflex, stated by doctor on 2/5/01. Y Y 11/28/2000 Result from culture obtained on 1/13/01-haemophilus parainfluenza PVT PUB NONE URI; GERD GERD with failure to thrive 1
0165819 02/13/2001 VI M 01/30/2001 Less than 24 hours, post vax, pt had a low-grade fever, crying fits and less arm movement. Brought to MD. Parents reassured but cautioned to call MD if symptoms persists. Contacted mom the next day and child is ok; no more fever. Y Y 01/22/2001 01/23/2001 1 NONE PVT UNK NONE Mild milk allergy 1
0165820 02/13/2001 NC 5.0 5 M 02/01/2001 5 X 7 raised, edematous, inflammed area of dorsal right thigh, warm to touch, 12 hours, post vax. Treatment: ice pack, Motrin and Benadryl PRN and return if needed. Y Y 01/31/2001 02/01/2001 1 PVT PUB NONE Allergy to PCN, Amoxicillin, Cefzil, Latex NC00015 1
0165821 02/13/2001 OH 2.0 2 .8 M 02/07/2001 Mom reports that soon after vaccine was given, pt had redness of injection site starting. No worse than initially and no interference with activity. Still ambulating well. Office visit on 2/7/01, mom reports no increase in redness but questionable increased edema. Area with 2" X 1 1/2" of erythema, edema and hot to touch. Bears weight. Treat with Tylenol prn and cool compresses. Will monitor for worsening. Y U 02/05/2001 02/05/2001 0 NONE PVT UNK NONE NONE Allergic to Phenergan 1
0165822 02/13/2001 WA 1.5 1 .5 F 02/05/2001 Fussy and not want to walk on the leg that she got the shot in. Y Y 01/30/2001 PVT PUB 1
0165823 02/13/2001 KY 1.0 1 .0 M 02/07/2001 Fever 101F, within 1 hour, post vax. Pt was "floppy and limp" with decreased responsiveness. Y Y 02/07/2001 02/07/2001 0 NONE PVT UNK NONE NONE 1
0165824 02/13/2001 FL 1.5 1 .5 F 02/08/2001 The mother noted a golf ball sized swelling on 2/6/01 one day post vax. It progressed the next day to involve entire thigh from knee to inguinal area with redness, firm to touch non-tender. The pt still acting normal. Swelling down slightly on 2/8/01. Y 02/05/2001 02/06/2001 1 NONE PVT PVT NONE viral URI NONE 1
0165825 02/13/2001 KY 0.2 0 .2 M 02/01/2001 On 1/8/01, MD evaluated a knot on pt's head as a cyst. Pt was referred to another doctor. CT Scan ordered and on 1/24/01 was read as having no lesions or masses. Cyst on parietal area, resolved. Y Y 12/20/2000 01/08/2001 19 CT Scan of head-no lesions or masses PUB PUB NONE NONE Torticollis KY2001008 1
0165826 02/13/2001 KY 0.8 0 .9 F 01/24/2001 Rash started on head and spread to rest of body over a period of 24 hours. Treated with Benadryl. On 2/9/01, pt's mother stated rash had completely covered child but rash is healed. Y N 01/27/2001 01/28/2001 1 PVT PUB History of Otitis Media; hospital admission on 1/20/01-1/21/01 for Bronchiolitis. KY2001007 1
0165827 02/13/2001 GA 0.7 0 .7 F 02/05/2001 Pt started with hives on trunk. On 2/3/01, by the end of day, had a temperature of 103F, increased hives and itching. Went to ER and they gave Benadryl, Tylenol alternating with Motrin. On 2/4/01, swelling hands and feet. On 2/5/01 to ER and referred and they think is Prevnar. If no better in 3 days, return. Y Y 02/02/2001 02/03/2001 1 PUB PUB On Amoxicillin for 8 days before shots. NONE 1
0165828 02/13/2001 NY 0.75 0 .8 F 02/06/2001 On 1/23/01, went to the ER with a high fever of 105.2F. While in the ER, was noted to have a seizure lasting less than 20 seconds. Returned to normal after that. Y Y 01/22/2001 01/23/2001 1 Chest X-ray-nml; UA-neg; WBC-7.6 PVT PUB NONE NONE ALTE-4/00; was on monitor until 2 months of age Fever~Pneumo (Prevnar)~1~0.50~In Patient 1
0165829 02/13/2001 IL 1.3 1 .3 M 02/06/2001 8cm X 5cm area of swelling noted to left thigh with some central induration. Y 02/02/2001 02/02/2001 0 NONE PVT PUB NONE NONE 1
0165830 02/13/2001 WI 36.0 34 M 02/06/2001 Fatigue, malaise, foggy-headed feeling; started in August 1999, got significantly worse in May 2000. November 1999 through March 2000 had severe knee and jaw pain. Had elevated liver enzymes and other GI symptoms since June 2000 and are ongoing. Vision changes noted over past several months. Had other symptoms, too numerous to list her; may or may not be related. Received follow-up Lymerix injections in June 1999 and May 31, 2000. Y N 05/07/1999 08/01/1999 86 CBC-irregularities; equivocal syphilis test results, Lyme test, Mono test, checked testosterone and thyroid, tested for HIV and STDS PVT OTH Depo-Testosterone; Toprol XL NONE Testosterone deficiency; mitral valve prolapse, enlarged heart, borderline high blood pressure 1
0165831 02/13/2001 TX 41.0 40 M 10/10/2000 Post vax, Anthrax #4 (within 2-3 days) left peripheral 7th nerve palsy. Post vax, Anthrax #2 (within 2-3 days) left peripheral 7th nerve palsy. Y 08/11/2000 08/13/2000 2 Lyme-(-); RPR-nml; MRI of brain with 6AD-(-) MIL MIL NONE NONE NONE 1
0165832 02/13/2001 46.0 46 M 02/07/2001 Pt had significant swelling of upper left arm, starting 24 hours, post vax, 2nd dose of Anthrax vaccine. Y Y 02/05/2001 02/06/2001 1 NONE MIL MIL Allegra, Decomanine, naproxen, Baycol NONE NONE 1
0165833 02/13/2001 PA F 02/01/2001 Light rash of lower extremities. No hives. Returned to clinic about 15 minutes, post vax. No SOB or dyspnea. Treated with Benadryl po X 24 hours. Y 01/18/2001 01/18/2001 0 PUB OTH NONE NONE 1
0165834 02/13/2001 PA 12.0 M 01/29/2001 Pt given flu shot in left deltoid and Pneumovax in right deltoid on 1/26/01. He presents to office with painful left arm and axillary lymphadenopathy. U 01/26/2001 01/28/2001 2 NONE UNK UNK NONE Questionable asthma 1
0165835 02/13/2001 PA 73.0 72 M 01/26/2001 Pt received flu vaccine on 12/1/00 in left deltoid. On 12/14/00, pt complained of some pain at site and returned to clinic on 1/25/01 with severe pain, needle-like feeling in the area and swelling. MD noted some irregularity in area. Comfort measures employed, NSAIDS and pt referred to physical therapy. Y U 12/01/2000 12/14/2000 13 UNK UNK Phenytoin, lansoprazole, beclomethasone, albuterol, alendronate, simvastatin Allergy to aspirin and "caines" group of anesthetics 1
0165836 02/13/2001 MS 38.0 38 F 02/01/2001 Received pneumonia and flu vaccines on 1/30/01. Complained of right arm where pneumonia shot was given as being swollen and painful to touch. Site edematous and warm to touch. N 01/30/2001 01/31/2001 1 PUB PUB Accolate, Vanceril NONE Ibuprofen, Keflex allergies; asthma MS01005 1
0165837 02/13/2001 NM 58.0 58 M 01/21/2001 On 1/18/01, begin having right ear and neck pain. At noon, started getting leg aches. PCP Rx's with antibiotic Zithromax X 5 days; beginning swelling and again went to PCP. Dx'd peritonitis and Rx'd another antibiotic but got GI symptoms. Rx'd with steroid for swelling; stayed swollen for 4 days. Saw PCP again on 1/23/01. On 1/18/01 had fever and chills. Went to dentist for cleaning on 1/3/01 and complained of gum discomfort on left side, 5 days later. Y Y 01/16/2001 01/18/2001 2 PUB PUB NONE NONE NONE 1
0165838 02/13/2001 CA 4.0 4 F 02/01/2001 Swollen, indurated area on left arm and tender to touch. Y 01/30/2001 01/31/2001 1 PUB PUB NONE 1
0165839 02/13/2001 NY 21.0 21 M 01/16/2001 Student states, his hands and face began to itch approx. 15 minutes, post vax, with generalized redness. Was given Benadryl po 50mg with good results. BP-140/90; AP-90; T-98F; anxious, breathing easy. Signs and symptoms upon discharge from IZ area. Y 01/16/2001 01/16/2001 0 OTH PUB NONE Seasonal allergies 1
0165840 02/13/2001 TX 75.0 75 F 02/06/2001 Administration site swelled with redness and felt warm to touch. MD gave pt antibiotic to ward off infection. Y 02/05/2001 02/06/2001 1 PVT PVT Norvasc, Celebrex, Prednisone SOB, cough HTN; CVA 1
0165841 02/13/2001 MT 1.3 1 .3 F 02/02/2001 24 hours, post vax, injection site became inflamed, swollen and hot into joint area and to knee (left VL). Child did not run a fever. Local reaction only. Seems to be itching. 48 hours, post vax, much improved. Y 01/31/2001 02/01/2001 1 NONE UNK UNK MT0106 1
0165842 02/13/2001 MS 30.0 30 F 02/03/2001 Post vax, pt had redness, swelling and itching at site of injection, erythema 6cm and warm to touch. Provider thought reaction to bandaid, due to print of bandaid on arm; no redness. On 1/16/01, pt had Hep-B/MSD/0721K/IM/LA/#6 with redness, swelling and itching, middle to lower third of upper arm and warm to touch but non-tender. Nothing at site of injection. No bandaid applied at this site. Pt received 3 doses of HBV, out of state, 2 years ago but had no reaction. Needed proof so repeated series. Y Y 10/20/2000 10/21/2000 1 NONE PVT OTH NONE NONE NONE MS01004 1
0165843 02/13/2001 AR 0.9 0 .9 M 01/17/2001 Swelling and redness a little larger than the size of a quarter on left deltoid X 7 days. U 01/11/2001 01/11/2001 0 NONE PUB PUB NONE NONE NONE AR0108 1
0165844 02/13/2001 MA 13.0 13 F 02/05/2001 Urticaria, starting a few hours, post vax, and persistent X 9 days. On 2/2/01, seen by health care professional and treated with Benadryl. No further follow-up. Y Y 01/24/2001 01/24/2001 0 PVT PVT Sickle Cell Disease Allergies to folic acid and morphine 1
0165845 02/13/2001 MO 0.75 0 .8 F 01/22/2001 On 1/17/01, approx. 12:15, mother complained of redness at child's injection site on right and left legs. No distress noted, happy affect and no respiratory problems noted. Ice packs were applied bilaterally and instructed mother to give Benadryl. At 14:00, per telephone call to mother, she verbalizes pt is doing well. On 1/18/01, father brought child to office. Examined by MD. Left leg had no redness noted. Right leg had redness and was warm to touch. MD instructed parents to give baby Benadryl. On 1/22/01, telephone call from parents, states per interpreter, baby not laughing and temperature 103F today. Instructed to go to ER. On 1/23/01, mother states she saw MD and he treated her for ear infection. Y Y 01/17/2001 01/17/2001 0 NONE PUB OTH NONE NONE NONE MO2001005 1
0165846 02/13/2001 NC 0.75 0 .5 M 01/31/2001 Approx. 4 hours, post vax, pt had 45 second interval of petit mal seizure. Y 11/13/2000 11/13/2000 0 NONE PVT PUB NONE NONE NONE NC00014 1
0165847 02/13/2001 NC 1.2 1 .0 F 02/01/2001 Herpes Zoster infection on nose. Y U 11/15/2000 01/31/2001 77 NONE PVT UNK NONE Otitis Media NC00016 1
0165848 02/13/2001 MI 4.0 4 F 02/02/2001 Redness, sore, itchy and warm to touch at injection site on right buttocks. Was told to use Benadryl cream. Y 01/31/2001 02/02/2001 2 PVT PVT Pt also had 1st PPD/Connaught/C0152AA/RFA on 1/31/01. NONE NONE 1
0165849 02/13/2001 GA 4.0 1 .3 F 02/05/2001 Chicken pox. Y Y 12/12/1997 01/30/2001 1145 PVT PUB 1
0165851 02/13/2001 NJ 6.0 6 M 02/05/2001 Pain and swelling at injection site for 72 hours. Child claimed entire arm hurt. Reaction began within 2 hours, post vax. Treated with Tylenol. Y 01/25/2001 01/25/2001 0 NONE PVT UNK NONE NONE NONE Fever and swelling~DTP (no brand name)~~0.00~In Patient 1
0165852 02/13/2001 NJ 1.4 1 .5 M 02/05/2001 Fever of 102F, within 6 hours, post vax, and 5 hours of non-stop crying, irritability and unable to sleep. Fever has been sporadic for nearly 10 days. Doses of children's Motrin used for fever. Y 01/25/2001 01/25/2001 0 NONE PVT UNK NONE NONE NONE ~Vaccine not specified (no brand name)~~0.00~In Sibling 1
0165853 02/13/2001 MI 29.0 29 F 01/31/2001 Went to ER on 1/18/01 at 20:00, due to rash and hives all over body. Received a shot of Benadryl and Prednisone 20mg and 1 Pepcid AC and sent home that day. Denied dyspnea. Continues to have rash and itching. Y N 01/17/2001 01/18/2001 1 NONE PUB PUB NONE History of Crohn's disease, Diabetes Mellitus, Allergies to PCN, codeine, Motrin and sulfa. MI2001013 1
0165854 02/13/2001 MI 36.0 36 F 01/25/2001 Received Havrix #1 in left deltoid on 1/22/01. Noted urticaria at injection site and began scratching area, immediately after injection. At home, noted she had broken skin when scratching. Area of itchy, fine, red rash has since spread to entire left upper arm, from elbow to shoulder. No fever, but did come down with a head cold the next day. No respiratory distress. Y 01/22/2001 01/22/2001 0 PUB UNK Noted PCN allergy, questionable type of reaction. MI2001014 1
0165855 02/13/2001 NY 5.0 5 M 01/25/2001 This AM, hands and feet were red and swollen. Hives were on face and torso; HEENT- unremarkable. Y U 01/24/2001 01/25/2001 1 PVT UNK NONE NONE 1
0165856 02/13/2001 IL 56.0 56 F 02/08/2001 On 02/08/01, this patient's right upper ext. is swollen, and tender. Prescribed Benadryl, Ice today, then warm compresses tid thereafter. U 02/06/2001 02/07/2001 1 PVT PVT Exacerbation of COPD, Left Maxillary Sinusitis. None 1
0165857 02/13/2001 IL 65.0 65 F 02/08/2001 This patient's left deltoid was swollen, red, warm to the touch, from the shoulder to the elbow to the entire upper arm. She was seen in the ER and prescribed Benadryl on 02/06/01. ON 02/07/01, the patient was seen in the office and given steroids and warm compresses. The local reaction is not resolved as yet on 02/08/01. Y U 02/06/2001 02/06/2001 0 PVT PVT NONE COPD, Squamous cell cancer (carcinoma) radical neck with larynx injection. 1
0165858 02/13/2001 IL 61.0 61 M 02/08/2001 On 02/08/01, this patient had a reaction 20-30 cm edematous and erythematous, warm area right upper arm. Prescribed warm compresses and steroids. U 02/06/2001 02/07/2001 1 PVT PVT NONE Hyperlipidemia 1
0165859 02/13/2001 WI 67.0 68 F 02/06/2001 On 02/02/01, this patient felt tenderness in her left arm. ON 02/03/01 , the patient's left upper arm was tender, swollen, with 1 quarter size spot (red) at the site of the injection. Another smaller red spot closer to the body. On 02/04/01, the spots got larger , area swollen, itching, and painful. She called the ER and was advised to use Benadryl, Ibuprofen and warm pads. On 02/04/01, the patient's sickness increased so the patient went in to the ER. The MD suspected an infection but he was not sure it wasn't a reaction to the vaccine. The patient received a prescription for Keflex, and she was advised to continue the Benadryl and Ibuprofen. On 02/06/01, the patient saw her own MD and she was advised to not have another TD vaccination and to continue the Keflex until gone. The swelling and inflammation are down but she can still feel a soreness in the upper arm. Y Y 01/31/2001 02/02/2001 2 PUB PUB Amoxicillin (1 week earlier) Resolved stomach problem (1 week earlier) Bad back. 1
0165860 02/13/2001 MN 1.75 1 .8 F 02/01/2001 This child has redness and swelling at the site of injection. Y 01/29/2001 01/30/2001 1 NONE PVT UNK NONE NONE NONE 1
0165863 02/14/2001 KY 57.0 57 F 02/08/2001 This patient developed swelling of his eyes 27 days after his vaccine, followed by fever, arthralgia, and pleural effusion. She was hospitalized from 01/04 - 01/10/01 with uncertain diagnosis 1. Seronegative RA, 2. viral syndrome, 3. Adverse reaction to vaccine. She is improving. Still has joint pain. Y Y 6 Y 12/11/2000 12/20/2000 9 Increased Sed rate, Pulmonary Infiltrate, Pleural Effusion. PUB PUB ibuprofen, Prempro NONE Osteoarthritis KY2001010 1
0165865 02/14/2001 IL 0.2 0 .2 F The pt experienced cardiopulmonary arrest. Was admitted to the hospital. Y Y 26 Y Y 02/21/2000 02/21/2000 0 PVT PVT NONE NONE NONE 1
0165866 02/14/2001 NY 3.2 3 M 02/07/2001 Information has been received from a physician concerning a 4 year old caucasian male who on 2/12/98 received the 1st vaccination of MMR II. On 11/17/00, the pt received the 2nd MMR II in the right thigh. He also received DTAP + IPOL. On 11/17/00, later in the evening, the pt's parents called the physician to report the pt had changes in his voice, swelling of lips, edema, and hives. The pt's respiratory status was stable. The pt did not have wheezing or stridor. The pt was given hydroxyzine HC1 (Atarax) but "spit it out". The pt was then given Benadryl and his symptoms resolved. On 12/4/00, the pt's mother called the physician concerned about "lisp". The pt's mother was worried that the pt's speech change could be due to the vaccines. The pt was referred to speech therapy and the evaluation is pending. In further follow-up, the pt's physician did not feel that the lisp was related to the child's vaccinations. She indicated the child has been referred to speech therapy and that as far as she knows, the lisp is still present. The physician also reported that the child has "recovered completely" from his other symptoms. Additional information has been requested. The changes in voice, lisp, swelling of lips, edema and hives were considered to be "Other Medical Events". The changes in the pt's voice and lisp were considered to be disabling. Follow-up info corrected the date of vaccination and date of onset. Also, previous vaccination date was changed. Y Y N 01/17/2000 11/17/2000 305 Speech rehabilitation-evaluation pending PVT PVT Frequent ear infections WAES00122280 1
0165867 02/14/2001 WI 1.0 1 .0 F 01/19/2001 On 1/17/01 the pt went to bed at 8:30 PM, woke up at 10:30 PM with an elevated temp of 103.4 rectally. The pt was given Advil. At 2:15AM seizures started affecting body. The pt was taken to ER. Valium was given rectally, child then vomited, seizures stopped but the child was lying limp on left side of body, unable to hold up head. The child was transferred to a pediatric ICU at another facility. The pt was still unable to use the left side of body. All tests were negative. Child went home from hospital on 1/19/01. Y Y 2 Y 01/17/2001 01/18/2001 1 CT scan, spinal tap, urinalysis, blood culture - all negative PUB PUB WI0112 1
0165874 02/14/2001 MA 8.0 8 M 02/08/2001 It was reported that an 8 year old male pt received a Fluzone SV '00-'01 vaccination on 1/16/01. Reportedly, the pt experienced a seizure 20 hours, post vax. New onset of seizures; no fever. Pt was evaluated in ER and discharged home. Further information is requested. F/U correspondence rec'd on 4/18/01, additional pt vaccine,resposible physician vaccine administrator and lab data were provided. F/U rec'd on 5/7/01, the following information was provided: vaccine was given in the pt's deltoid. The pt had no history of seizures before the vaccination. The current medical condition of the pt is stable, no seizures. Y U 01/16/2001 01/17/2001 1 CT scan -negative, EEG follow-up - no further seizure activity PVT OTH Creon, Tobi, Pulmozyme, Adex, Multi-vitamin NKDA, cystic fibrosis U2001003740 1
0165875 02/14/2001 PA 52.0 M 02/12/2001 Report 2001003514-1 describes joint pain in a 52 year old male who received Lyme disease vaccine (Lymerix). This report was received as part of litigation proceedings and has not been verified by a physician or other health care professional. Medical history included tick bite one week prior to receiving the first injection of Lymerix. The physician treated the patient with doxycycline. The patient received his first injection of Lymerix in April 2000. At some later, unspecified date, he developed "significant" joint pain, which made the patient feel as though he was "becoming like a cripple". The joint pain resolved after "a short time". The patient received his second injection of Lymerix on 05/04/00. At some later, unspecified date, the patient again experienced "significant" joint pain, which made him feel as though he was "becoming like a cripple". As of 02/01/01, the joint pain "had not totally resolved". The adverse experience of joint pain does not meet ICH serious criteria, but is being submitted as an expedited report by special FDA request per the June 28, 2000 letter. N 05/04/2000 OTH OTH Tick Bite Significant joint pain for a short time~Lyme (LYMErix)~1~52.00~In Patient 20010035141 1
0165876 02/14/2001 KY 3.0 3 F 02/07/2001 On Tuesday morning at 10:30 AM, this child had a temperature of 101. Treated her with Tylenol / Motrin alternating. Temperature 104 by 9 PM, went to the ER. The patient was diagnosed with bronchitis, otitis media, and tonsillitis. Y Y 02/05/2001 02/06/2001 1 PUB OTH Stuffiness NONE KY2001009 1
0165877 02/14/2001 PA F 02/12/2001 Report 2001003418-1 describes arthritic-like joint pain in a female who received Lyme disease vaccine. The patient participated in a Lyme disease vaccine clinical trial; the protocol was not specified. The arthritic-like joint pain was reported spontaneously post-marketing. This report was received as part of litigation proceedings and has not been verified by a physician or other health care professional. The patient claims to have received placebo as part of a 1996 clinical trial of Lyme disease vaccine. After the blind had been broken, the patient reportedly was offered and accepted open-label Lyme disease vaccine in 1997. The number of injections of Lyme disease vaccine received by the patient was not specified. At some unspecified time after she had received Lyme disease vaccine, the patient began to experience arthritic-like joint pain. The study investigator reportedly told the patient that Lyme disease vaccine "had nothing to do with the pain". The outcome of this event was not provided. The adverse event of arthritic-like joint pain does not meet ICH serious criteria, but is being submitted as an expedited report by special FDA request per June 28, 2000 letter. U OTH PVT 20010034181 1
0165878 02/14/2001 MO 0.75 0 .8 F 01/29/2001 This infant has 2 episodes of vomiting since her vaccination. Y Y 01/29/2001 01/29/2001 0 PUB PUB NONE NONE MO2001006 1
0165879 02/14/2001 RI 1.8 1 .8 M 01/23/2001 This child has a large, red, raised area surrounding the injection site Y 01/19/2001 01/19/2001 0 PVT PUB NONE NONE NONE 1
0165880 02/14/2001 MI 0.5 0 .5 M 01/23/2001 The parent states the child was in the clinic on 01/18/01 to receive vaccines. On 01/19/01, the child became lethargic all day. On 01/20/01, the parent states she noted a rash on the child's face and trunk of body. On 01/21/01, the rash spread to his legs and buttocks. The parent called the physician on 01/21/01 and was instructed to give the child Benadryl. Y Y 01/18/2001 01/19/2001 1 PUB PUB NONE NONE NONE MI2001011 1
0165881 02/14/2001 MI 4.0 4 M 01/19/2001 Immunizations given at 7 PM. The patient complained of dizziness at 10 PM. At 3 AM the patient wet the bed (does not usually), Temp 103, vomiting. The patient's father called at 10:30 AM still vomiting, right arm reddened, no swelling. The mother reports on 01/22/01, the child is afebrile, eating well. The sister had vomiting on 01/17/01. Y 01/18/2001 01/18/2001 0 PUB PUB NONE NONE NONE MI2001010 1
0165882 02/14/2001 MI 78.0 77 F 12/01/2000 The patient woke up on Thursday night with a red rash, now raised or blistered, over the entire body. On 12/21/00, follow up phone call with the patient. Contacted the doctor per PHN recommendation on 12/01/00. was instructed to take OTC Benadryl which resolved the rash. Encourage follow up with the doctor before taking another Flu shot. Elevated symptoms next time. Y 11/29/2000 11/30/2000 1 NONE PUB PUB NONE NONE MI2001012 1
0165883 02/14/2001 RI 54.0 54 F 01/11/2001 This patient had bad swelling of her cheeks and lips. She received a shot on 01/05/01 at 12 noon. On 01/06/01 in the AM Benadryl every 6 hors 01/06/01 - 01/07/01. Y 01/05/2001 01/06/2001 1 OTH PVT Privil, Nedral, Prednisone, Lipitor. Kidney disease, (2) kidney transplants. 1
0165884 02/14/2001 WI 79.0 79 F 12/13/2000 On 12/10/00 at 4 AM, the patient woke up with symptoms of diarrhea (approx 6 episodes) in a short time. Took Immodium. Same scenarios on Monday and Tuesday (12/11 & 12/12) of 2-3 episodes in the morning and early evening. Contacted HCP: informed them of many cases of diarrhea. Advised to take 3 doses of Immodium on Tuesday. No diarrhea today 12/13/00. Y 12/07/2000 12/10/2000 3 PUB PUB NONE WI0108 1
0165885 02/14/2001 WI 58.0 58 F 12/11/2000 On 12/05/00, Wednesday night, the patient's body ached, headache, arms red, swollen. Took Ibuprofen, Doxycycline ordered by the PMD. Today arm red all away around, swollen, itchy, painful encouraged to recall HCP. On 12/19/00 the patient states arm much better, less red and swollen, but still firm and itching at the injection site. To call for an appt with HCP when road conditions improve. Y N 12/05/2000 12/06/2000 1 NONE PUB PUB Premarin, Inderal, Prozac, Ketrofen. NONE WI0113 1
0165886 02/14/2001 WI 74.0 74 F 01/16/2001 Vaccine was administered 11:45 on 12/19/00. At about 8 PM on 12/19/00 she had a slight numbness in her left hand. On 12/20/00, she experienced shoulder blade pain. The pain increased and varied in different parts on the left arm. She saw her primary MD on 01/02/01 or 01/03/01, because of pain and numbness in arm and fingers .The patient reported that she had "nerve damage all over her arm". Treatment continues with Vicodin, Tylenol, exercises, heating pad, follow up appointments. Y N 12/19/2000 12/19/2000 0 Nerve Conduction test 01/11/01 PUB PUB Coumadin, MVI, Ca+, Norvasc, Vitamin C. NONE Hypertension, ovarian cancer 20 years ago, 12/5/00 surgery for colon cancer. WI0110 1
0165887 02/14/2001 WI 48.0 48 F 12/21/2000 This patient had a red area, swollen, hot about 4 inches in diameter. On the 5th day the area became very hard and reported to Health Dept on the 6th day for advice. Pinpoint papule noted with appearance of whitehead. The patient was sent to PMD. The patient had been using cold compresses and taking Ibuprofen. The PMD reports possible cellulitis, patient put on Keflex. Y 12/14/2000 12/19/2000 5 PUB PUB NONE Had a local reaction to TD in the past- redness and swelling. WI0109 1
0165888 02/14/2001 WI 39.0 39 F 12/27/2000 This patient developed black and blue left arm and into left wrist 5 cm size lump above left collar bone. Called HCP and will be seen today. Y Y 12/21/2000 12/22/2000 1 Chest X-ray - awaiting results. PUB PVT Celexa, Ibuprofen, Lorazapan. NONE NONE WI0107 1
0165889 02/14/2001 NM 79.0 78 F 02/09/2001 After receiving injection Pt developed immediate aching and pain at site. Pt has experienced aching at site extending down arm. Pt reports limitation in motion, problem on going. Pt being sent to PMD for evaluation and work-up. Y U 12/14/2000 12/14/2000 0 PUB UNK vitamins NONE 1
0165890 02/14/2001 AL 1.94 1 .9 F 02/02/2001 Pt has fever of 103-104 for 2 days. Diagnosed with otitis media, seen in office 2/1 9:20-10:30am - treated with Amoxil, also received 2nd influenza vaccine, has history of reactive airway disease. Pt presented on 2/1 at 14:30 to ER with 103 temp, febrile seizure lasting 7-8 minutes stiffening of extremities, eyes rolled upward. Pt received IM Rocephin for otitis media. Pt discharged from ER at 0045 2/2/2001, alert, nontoxic. Y Y 02/01/2001 02/01/2001 0 PVT PUB bilateral otitis media reactive airway disease, former 32 week preemie, develop delay, speech delay. AL0101 1
0165891 02/14/2001 OH 68.0 68 F 02/15/2001 12 hours post vax for flu had substantial muscle soreness, pain in arm at injection site and most of all in whole body side, shoulder, back neck back, Got massage therapy which helped reduce pain. 3 weeks post still having residual effects. Y 01/10/2001 01/10/2001 0 PVT UNK Zantac 75, Prilosec NONE chronic sinus problems (nasal) 1998~Influenza (Seasonal) (no brand name)~~66.00~In Patient 1
0165892 02/14/2001 WI 8.0 8 F 01/16/2001 Pt's mother called 1/16/01 to report her daughter received Varivax 1/11/1. She developed facial and neck rash on 1/14/2001, which resolved. She developed trunk rash on 1/15/01, which resolved by 1/16/01.She called family MD who told her to report to health department. Rash was red/raised but not pustules or drainage. None at injection site. Y 01/11/2001 01/14/2001 3 NONE PUB PUB NONE NONE NONE WI0111 1
0165893 02/14/2001 VA 11.0 11 F 01/29/2001 This child complained immediately of extreme burning in arm. Bleeding when needle was pulled out of skin but there was no blood when plunger pulled back prior to injecting vaccine. One hour at home, the child was complaining that her chest hurt and she started coughing. I advised the mother to give her Tylenol and apply ice to injection site. Never complained of shortness of breath to my knowledge, but the mother called back in about thirty minutes and reported severe arm pain, crying, crying, more chest pain along with coughing. Advised to call private physician or go immediately to the ER. Two hours later the child was seen at the ER and was given a cough medicine that contained Codeine and the mother reported the doctor said that the child had a cold starting. The mother also said that after the child got back home she had taken the cough medicine and relaxed that she felt better. The child went to school the day after the episode, the mother said that she still had a "sore arm", then. NOTE: the client before this child was extremely loud when given his immunizations and required most of the clinic staff. Y Y 01/24/2001 01/24/2001 0 PUB PUB NONE NONE NONE VA01006 1
0165894 02/14/2001 IN 1.7 1 .6 M 01/26/2001 On 12/18/00, the patient had an office visit, parent complained of child being cranky, irritable, lethargic with fever on and off since immunizations. Temperature 103 on Saturday. When seen at the office the temperature was 96.5; rash just started on his chest, back and groins. TM's slight redness, Tympanometry R72, L115, right thigh was red. On 12/19 called the patient crying and pulling on ears. On 12/22, the patient was doing better not on Zithromax, but Claritan. Y 12/13/2000 12/13/2000 0 PVT UNK NONE URI, Afebrile. NONE 1
0165895 02/14/2001 RI 15.0 14 F 01/25/2001 This patient had a red raised warm 5 cm in diameter. Y 01/15/2001 01/20/2001 5 PVT PUB Tuberculine - Parkdale, lot # 00950P, right forearm, 1 previous dose. Allegra, Flonase. Nasal congestion. Stress induced asthma. 1
0170244 02/14/2001 ND 24.0 24 M 02/08/2001 Pt did not want to get Anthrax shot but did comply as directed. 5 minutes, post vax, he reported to Flight Med front desk complaining of dizziness. Orthostatics were wnl, no respiratory symptoms. Neuro exam was wnl. After 15 minutes, pt felt better. Released from duty and deployed to air base the next AM. Y Y 02/07/2001 02/07/2001 0 NONE MIL MIL NONE NONE G6PD-difficiency 1
0165908 02/15/2001 VA 30.0 21 F 02/13/2001 A physician reported that a 30 year old female received an injection of vaccine, in November, 1990. In January, 2001, the patient was hospitalized for the diagnosis of pneumococcal sepsis, serotype 9N. While hospitalized, the patient was ventilator dependent for 3 days and had no urine output for 2 days. The reporter did note that the patient had received and injection of pneumococcal vaccine in September, 2000. Follow up information received on 04/04/2001, indicated that this patient was 31 years old and was hospitalized for more than 30 days. Upon further medical review the code of intubation NOS was removed from the case. Y 30 U 11/01/1990 01/01/2001 3714 UNK PVT PVT Prednisone UNK Systemic Lupus Erythematosus HQ7116412FEB2001 1
0165911 02/15/2001 NY 50.0 50 F 02/13/2001 After the 2nd vaccine, this patient had joint and muscle pain, generalized muscle spasms, onset of illness 12/00. Pain medication, anti-anxiety, depressants, and sleeping medication given. Y Y N 10/15/1999 12/01/2000 413 HLA-DR4-positive PVT PVT Positive Lyme disease test-no symptoms 1
0165912 02/15/2001 PA M 07/19/2001 Report 2001003496-1 describes joint pain in a male who received Lyme disease vaccine. The patient participated in a Lyme disease clinical trial; the protocol was not specified. The adverse event was reported spontaneously post-marketing. This report was received as part of litigation proceedings and has not been verified by a physician or other health care professional. The patient claims to have received placebo as part of a Lyme disease clinical trial. After the blind had been broken, the patient reportedly was offerred and accepted open-label Lyme disease vaccine. He received his first injection of Lyme disease vaccine in March 1997. No adverse experience was reported following this injection. He received his second injection of Lyme disease vaccine in 04/97. In 11/97, three months following receipt of the second injection, he began to experience slight pain in his arm joints. The patient received his third injection of Lyme disease vaccine in the spring of 1998. Within one week of receiving the third injection, his joint pain became severe and affected all of his joints. The joint pain was described as "burning and cramping". He had "the sensation of a hundred razor blades poking his knee joints, hips, ankles, wrists and elbows." The outcome of the joint pain was not provided. The adverse event of joint pain does not meet ICH serious criteria, but os being submitted as an expedited report by special FDA request per the 06/28/00 letter. U 04/01/1997 11/01/1997 214 MIL PVT 20010034961 1
0165914 02/15/2001 IL 32.0 32 M 03/13/2001 Report 2001003650-1 describes joint aches in a 32 year old male who received Lyme disease vaccine. The patient received his first injection of Lymerix on 10/12/00. At some later, unspecified date, he experienced "severe" joint aches involving his entire body. The joint aches persisted. The patient did not report this event to his physician. On 11/17/00, the patient received his second injection of Lymerix. The "severe" joint aches involving his entire body persisted. The patient's spouse notified the physician of the joint aches. The patient has not been seen by the physician for evaluation of the joint aches. The adverse event of joint aches does not meet ICH serious criteria, but is being submitted as an expedited report by special FDA request per the 06/28/00 letter. N 10/12/2000 PVT PVT Allegra, Proventil, Flonase. Mild asthma, seasonal allergies. 20010036501 1
0165915 02/15/2001 OH 40.0 40 F 01/04/2001 12/5/00 immunized, 12/8/00. No second page attached Y U 12/05/2000 12/08/2000 3 Not available PUB OTH See attached. No page attached 1
0165916 02/15/2001 GA 4.0 4 M 02/09/2001 This child had erythema 8 x 10 am at the injection site with induration, 48 hours after injection. Y U 02/07/2001 02/09/2001 2 PVT UNK Allergic rhinitis Environmental allergies 1
0165917 02/15/2001 MI 22.0 22 F 02/10/2001 Pt reports left shoulder pain and swelling after 3rd Rabies vaccine injection. Did experience mild reaction to 1st and 2nd doses, temp of 97.4- pt denies breathing or swallowing difficulties. Localized reaction. Y U 01/31/2001 01/31/2001 0 OTH OTH NONE 1
0165918 02/15/2001 AZ 1.0 0 1 M 02/02/2001 This infant had a rash and a fever., Y 10/05/2000 10/14/2000 9 Rubeola IgG (10/19/99). Rubeola AD, IgM, If (11/2/99) PVT PVT NONE NONE 1
0165919 02/15/2001 OH 1.0 0 .0 M 02/12/2001 The patient had a vaccine, ten days later, the mother noted red "specks" not raised, on the child's face, arm, and stomach. The child also had a fever of 100.6. U 02/02/2001 02/12/2001 10 NONE PUB UNK NONE NONE 1
0165921 02/16/2001 ID 0.2 0 .2 M 12/30/2000 Infants cause of death SIDS Y 12/22/2000 N 12/18/2000 PVT PUB Colic-resolving Colic-resolving ID01004 1
0165922 02/16/2001 FL 1.0 0 .8 M 02/13/2001 This infant died of cardiopulmonary arrest of unknown etiology; at this time autopsy is pending. Autopsy stated cause of death as acute encephalopathy. Y 12/13/2000 Y N 12/12/2000 PVT PUB Flovent, albuterol Gastroenteritis Chronic lung disease; prematurity 1
0165924 02/16/2001 ID 66.0 66 M 01/02/2001 This patient has Guillain Barre' Syndrome, He was hospitalized. Follow up 07/06/2001: "Final diagnosis was GBS. Patient experienced other previous illnesses or medical conditions before the onset of GBS, however, it was not stated. Patient was previously vaccinated with INfluenza prior." Y Y Y Y U 12/01/2000 12/15/2000 14 CT Scan head, CBC Chem panel - All Wnl PVT PVT Lescol, Verapamil, Zestril, Zantac, Coumadin, ASA, Vitamins NONE No known allergies, CAD, PVD, HTN, PUD, Oral CA, Hyperlipidemia ID01003 1
0165925 02/16/2001 FL 16.0 16 M 01/18/2001 A pharmacist reported that a 16 year old male received Antivenin Polyvalent, Equine following a snake bite on 10/26/00 and subsequently, developed a total body rash and became anxious. A second dose of Antivenin Polyvalent, Equine was administered following treatment with diphenhydramine and methlprednisolone; however, the infusion was discontinued because of rash progression. Additional information received 01/17/2001 indicated that the patient was hospitalized for 2 days. Y Y 2 U 10/26/2000 10/26/2000 0 UNK OTH OTH NONE Snake bite Allergies to PCN and acetylsalicylic acid; drug hypersensitivity HQ2950530OCT2000 1
0165929 02/16/2001 NM 63.0 63 F 02/13/2001 Information has been received from a health professional concerning a 63 year old female who on 9/22/00 was vaccinated with pneumococcal vaccine 23 polyvalent in the deltoid. On 9/24/00, the pt's arm was swollen, tender and very red from elbow to back. The pt was seen and treated at urgent care. The pt's experience was considered an "Other Medical Event" by the reporter. On 9/28/00, still not feeling well with a low-grade fever, no temperature elevation or swelling was noted. The physician notes stated "multiple constitutional symptoms, most likely secondary to pneumococcal vaccine 23 polyvalent (MSD)". Additional information has been requested. Y Y 09/22/2000 09/24/2000 2 CBC - nml, hepatic function - nml UNK UNK UNK COPD, hypothyroidism WAES00102088 1
0165932 02/16/2001 TX 1.5 1 .6 M The child was seen by a doctor for a viral illness and diagnosed with the flu. The father requested a flu shot for the child. The child screamed, held breath, left side tonic clonic seizure lasting 2-3 minutes, post ictal axillary temp during seizure of 101. Y Y 2 Y 02/06/2001 02/06/2001 0 Lumbar Puncture - CSF, Gluc 90, Prot 10, no growth, 1 WBC, U/A - Nml, CBC - Wnl, Chem: Gluc 170, CXR - Clear. MIL MIL NONE Viral URI with a fever hx of seizure, breath holding and fever 1
0165933 02/16/2001 MD 72.0 72 F 02/09/2001 On 11/9 the pt experienced dizziness and the pt was sent to the ER. Treated for high blood pressure. Stated fluid behind ear. On 11/10 began medication for elevated blood pressure. On 11/16 and 17. went to ER, blood pressure still elevated. Sent to the ER for a 3rd time treated by neurology for "viral infection". Y Y 2 Y 11/08/2000 11/09/2000 1 CT scan - neg, echocardiogram - nml, sinus x-rays PUB PUB NONE elevated cholesterol, allergies 1
0165934 02/16/2001 MA U 02/13/2001 A physician reported that an unidentified person may have inadvertently received an expired dose of DTP. The physician declined to proved any further information. Follow up information has been received from the reporter on 2/6/01. The physician explained that an unidentified attorney called to inquire if there are any known adverse effects of receiving an expired DTP vaccine. The physician states "I do not know who the pt is, nor what company produced the vaccine". It is unknown if the pt experienced any adverse event from this vaccine. U UNK OTH OTH UNK UNK UNK HQ5912615JAN2001 1
0165935 02/16/2001 ID 66.0 65 F 01/22/2001 The pt reports ringing in her ears which has gotten worse after each vaccine. She has completed the series. She also states that she has liver damage, her liver enzymes are high. Since receiving the vaccine, she has had to increase her thyroid medication to 3 times the dose. Follow up 03/20/2001: "On 01/24/2001, patient had first Hep A & B shot. That night patient's ears began ringing. In years past (2 times) patient taken 1 or 2 Tylenol and got both times, ringing in the ears for 3 weeks. Patient told a nurse and she said that it was a severe reaction and to never take Tylenol and that kind of product ever again and patient hasn't. On 04/07/2000, patient had the second Hep B shot and the ringing got much louder. On 08/03/2000 when patient went to finish the series, patient thought if ringing in the ears was a side effect of the Hep A and B shots. The nurse looked at her materials and said "no". So patient had the shot-regrefully. The ringing is very much louder, louder than the TV, road noise-it's terrible and has gone on all this time, never stopping. Sometimes the right ear is 2 times lower than the left ear but usually it's the same. Shots caused liver disfunction and thyroid mediccal event from 1 pick to 3. It's now down to 2 and seems to have stabalized. A former allergist told me that people with severe allergies and hydrocarbon & petrochemical sensitivity were not tested when the Hep A & B were studied. Patient has been badly affected by these shots. Patients liver disfunction is a great worry, patient is tired all the time and the ringing of the ears is rotten to put up with. Patient surely hopes you can help. You know, patient doesn't know what else those shots disrupted." Y N 08/03/2000 08/03/2000 0 PUB PUB Armourthyroid NONE allergy to hydrocarbons, petrochemicals, dust, pollens, sulfa, Tylenol ID01006 1
0165936 02/16/2001 TX 1.6 1 .6 M 02/13/2001 This patient in less than 72 hours after vaccines, began vomiting, diarrhea, fever, irritability, restless sleep, fat heartbeat, tired. The pediatric doctor refused to examine the patient and refused to file a report. Y N 02/06/2001 02/08/2001 2 NONE PVT OTH NONE NONE 1
0165937 02/16/2001 WI 51.0 M 02/14/2001 Report 2001003774-1 describes "achy knees" in a 51 year old male who received Lymerix for the prevention of Lyme disease. This report was received from the vaccinee and has not been verified by a physician or other health care professional. During the spring of 1999, the vaccinee received his first and second dose of Lymerix. In autumn, 2000, he received his third dose of Lymerix. Subsequently, he experienced "achy knees". The vaccinee has not been evaluated for this event, and no treatment has been given. As of 02/12/01, the outcome of this event is ongoing. The adverse event of "achy knees" does not meet ICH serious criteria, but is being submitted as an expedited report by special FDA request per the June 28, 2000 letter. N OTH OTH Mevacor Elevated cholesterol. No Allergies. No history of Lyme disease. 20010037741 1
0165938 02/16/2001 MA M 02/12/2001 Report 2001003649-1 describes joint pain in a male (age not provided) who received Lyme disease vaccine (Lymerix). The patient received an injection of Lymerix in October 2000. At some later, unspecified date, he experienced knee joint pain. The pain persisted as of 02/08/01. Additional information has been requested. The adverse event of joint pain does not meet ICH serious criteria, but is being submitted as an expedited report by special FDA request per the June 28, 2000 letter. N PUB PUB 20010036491 1
0165939 02/16/2001 NJ 53.0 52 M 02/09/2001 Report 2001003541-1 describes joint pain in a 53 year old male who received Lyme disease vaccine (Lymerix). This report was received from the patient and has not been verified by a physician or other health care professional. The patient reported receiving injections of Lymerix in May 1999, June 1999, July 1999, May 2000, and June 2000; this is greater than the recommended number of Lymerix injections. At some later, unspecified date, the patient experienced bilateral knee joint pain. No redness, edema, or heat was noted in the knees. The patient has not sought medical attention. The outcome of this event was not provided. The adverse event of joint pain does not meet ICH serious criteria, but is being submitted as an expedited report by special FDA request per the June 28, 2000 letter. Y U 06/12/2000 Lyme total antibody by EIA Lyme antibody by ELISA PVT PVT Colaar, viagra, claritin 20 lb weight gain since 1997. Hypertension, overweight 20010035411 1
0165940 02/16/2001 PA 54.0 F 02/14/2001 Report 2001003522-1 describes joint pain in a 54 year old female who received Lymerix. This report was received from a lawyer and has not been verified by a physician or other health professional. In the summer of 1998, the vaccinee was treated for Lyme disease. On 03/29/99, she was reported to be 100% better, except for some stiffness of the left hand. On that date she was given a prescription for Celebrex for her continued hand stiffness, and received the first injection of Lymerix. The hand stiffness reportedly continued, without changes, until the vaccinee received her second injection of Lymerix on 04/03/99. Following a dose of Lymerix, the vaccinee experienced joint pain, vision impairment, palpitations, chills and a bull's eye rash over the injection site. As of 02/01/01, the vaccinee continued to experience "significant joint pain, stiffness, fatigue, swelling of her hands and an impaired vision field in her left eye." The adverse events of "joint pain" and "stiffness" do not meet ICH serious criteria, but are being submitted as an expedited report by special FDA request per the June 28, 2000 letter. N 04/03/1999 OTH OTH Celebrex 03/29/99 Lyme disease 20010035221 1
0165941 02/16/2001 PA 47.0 M 07/06/2001 Report 2001003518-1 describes arthritic symptoms in a 47 year old male who received Lymerix. This report was received from a lawyer and has not been verified by a physician or other health care professional. On 09/22/99 and 10/23/99, the vaccinee received his first and second doses of Lymerix, respectively. Reportedly, by January, 2000, he began experiencing "severe joint pain of acute onset which worsened through February, 2000." As of 02/01/01, these arthritic symptoms "have not resolved, despite the prescription of rofecoxib (Vioxx), Prednisone, Methotroxate, and hydroxychloroquine phosphate (Plaquenil)." The adverse event of "arthritic symptoms" does not meet ICH serious criteria, but is being submitted as an expedited report by special FDA request per the June 28, 2000 letter. N 10/22/1999 01/01/2000 71 OTH OTH HLA-DR4 positive. 20010035181 1
0165942 02/16/2001 PA 76.0 F 02/14/2001 Report 2001003520-1 describes joint pain in a 76 year old female who received Lymerix. This report was received from a lawyer and has not been verified by a physician or other health care professional. On 05/27/99, the vaccinee received her first dose of Lymerix. "shortly therafter" she developed a "large rash on her stomach, joint pain, fatigue, and general flu-like symptoms". She was placed on unspecified oral antibiotic therapy starting on 06/10/99 and ultimately was administered intravenous antibiotics from 10/29/99 through 11/26/99. The intravenous antibiotics reportedly relieved "many" of her symptoms. As of 02/01/02, the vaccinee continued to experience joint pain and fatigue. The adverse event of "arthralgia" does not meet ICH serious criteria, but is being submitted as an expedited report by special FDA request per the June 28, 2000 letter. N 05/27/1999 UNK UNK NONE 20010035201 1
0165943 02/16/2001 PA 44.0 F 07/02/2001 Report 2001003631-1 describes pain in a female vaccinee of unspecified age who received LYMERIX. The information in this report is received via a journal article and has not been verified by a physician or other health care professional. In may 1999, the vaccinee received her second dose of LYMERIX. "Shortly after vaccination", the vaccinee began experiencing burning pain in her back, numbness in her arms, and aches and swelling in an ankle. "Just the thought of walking across the yard hurt me", said the vaccinee. By December, 1999, the pain was so intense, the vaccinee was considering reconstructive surgery for her ankle. As of 02/01/01, the outcome of the events in unknown. The adverse events of "numbness", "ankle pain", and "ankle swelling" do not meet ICH serious criteria, but are being submitted as an expedited report by special FDA request per the June 28, 2000 letter. U 05/01/1999 12/01/1999 214 OTH OTH NONE 20010035311 1
0165944 02/16/2001 SC 1.6 1 .5 F 02/13/2001 This infant had swelling, pain, redness with fluctuance and warmth at the injection site on the right upper thigh with splotching.. Y 01/22/2001 01/24/2001 2 PUB PUB URI NONE 1
0165945 02/16/2001 NJ 46.0 44 F 02/12/2001 This patient had a gradual onset of pain in both knees, left ankle and heel. General feeling of aching, trouble sleeping. Feeling as though hit by a truck. Climbing stairs became a problem. After 3-4 months she began to seek treatment, which lead to a rheumatologist diagnosis of fibromyalgia syndrome. Y 06/01/1999 09/01/1999 92 Elevated sed rate, negative for arthritis, lupus, etc. PVT OTH Dyazide, Flovent, Serevent, Flonase, Zyrtec. NONE Asthma, allergic to cat, dog, Penicillin, Amoxicillin, Macrodantin, Chloromycetin. 1
0165946 02/16/2001 MN 0.5 0 .5 F 02/08/2001 This infant had a fever of 100. Y U 02/06/2001 02/07/2001 1 NONE PVT PVT NONE NONE 1
0165947 02/16/2001 NJ 57.0 52 M 02/06/2001 After receiving my first series of Lymerix injections, I started to have gout like symptoms alternating between both of my ankles along with my knees. During this period a couple of uric acid test showed normal levels. My doctor has sent me to a podiatrist, who took x-rays, and extensive blood work, and he could not find anything wrong with my ankles. He then referred me to a rheumatologist, his diagnosis was I do not have arthritis, he thinks it is the gout. For the past 8 years I have a history of getting the gout once or twice a year without taking any preventative medication, only watching my diet. Since May 2000, I started with 100 mg of Alapurinol, then was increased to 300 mg, along with watching my diet without any help with the pain. When I do get the gout after taking my medication, colchicine 0.6 mg the swelling starts to subside within a few hours. This other swelling takes a few days to subside. None of the three doctors will admit to me my problems were from the Lymerix injections. U 05/02/2000 06/07/2000 36 07/00 Blood test for uric acid - Nml 10/00 x-rays, and Blood work - all Nml UNK UNK High blood pressure, rosachia. 1
0165948 02/16/2001 MD 34.0 34 F 02/01/2001 A 34 year old health care worker presented 12/19/00to request the Hep B vaccination, PPD placement, and the flu shot. On 12/21/00 the patient presented complaining of swelling and tenderness in the right supraclavicular area, no previous episode. No other area of tenderness, PPD negative. The area was examined by the RN and the MD. The right supraclavicular lymph node tender, moveable, 1 cm palpable. Injection site normal. The patient was told to take Tylenol or Motrin when necessary and return if not resolved in one week. Numerous follow up phone calls made unable to reach the patient. The patient presented to the MD today for unrelated problem. Reports that right supraclavicular pain and swelling completely resolved in 1-2 weeks after the injection. Area was examined no swelling, no tenderness, no cervical lad injection site WNL. U 12/19/2000 12/21/2000 2 UNK UNK PPD, left forearm, 12/19/00. Obesity, nonsmoker, no ETOH 1
0165949 02/16/2001 F 01/26/2001 The pt complained of funny taste in mouth, palate, tingling in back of head. Went to ER on 1/3/01 and 1/10/01. Complained of decreased circulation in LUE and LLE. Y U 01/03/2001 UNK UNK 1
0165950 02/16/2001 ID 49.0 49 F 01/04/2001 This patient's left arm had weakness and pain. Y N 12/05/2000 12/06/2000 1 PUB PVT Ibuprofen NONE NONE ID01002 1
0165951 02/16/2001 FL 0.2 0 .2 M 01/12/2001 Within 5 minutes after receiving his vaccinations the infant began having hives, got lethargic, not responding to normal stimuli, respirations shallow at 26, rash on face and body. The doctor was notified. Benadryl IM was administered. The infant was monitored for 5 minutes the injection rash disappeared. The baby then became responsive, respirations increased to 42, HR at 128. The baby was released home after monitoring for 30 minutes. Y 01/12/2001 01/12/2001 0 PUB PUB NONE NONE NONE FL01001 1
0165952 02/16/2001 MA 35.0 35 F 02/09/2001 This patient had a rash, myalgias, fatigue, and paresthesia of the hands. Y Y 01/18/2001 02/07/2001 20 PVT OTH NONE NONE NONE 1
0165953 02/16/2001 FL 0.7 0 .7 F 12/29/2000 Diffuse red papular rash on face, upper extremities and trunk which appeared 3 days, post vax of Hep-B #2. Denies exposure to new foods or products. Treated with Prelone X 3 days and Atarax. U 12/21/2000 12/24/2000 3 NONE PUB UNK NONE FL00052 1
0165954 02/16/2001 FL 2.0 3 F 12/26/2000 Erythematous rash started in left arm the next morning and spread to other arm, legs and trunk but not face. No fever or other symptoms. Rash still apparent at 13:30 on 12/26/00. Referred to Pediatric Clinic for evaluation and follow-up or ER prn. Y 12/22/2000 12/23/2000 1 PUB PUB NONE NONE History of febrile seizures (Mother speaks no English). FL00054 1
0165955 02/16/2001 ID 1.8 1 .8 M On 1/10/00, left deltoid swollen, red, hard to touch and hot. Mom says symptoms started right after IZ's and symptoms have gotten worse. Redness, tenderness had grown to under the arm this AM. Advised mom to call child's doctor. On 1/11/01, the doctor says that the child has cellulitis but he is feeling better. Treated with pain medicines and taking antibiotics. Y Y 01/09/2001 01/09/2001 0 PUB PUB NONE NONE NONE ID01001 1
0165956 02/16/2001 MD 8.0 3 F 02/02/2001 Mother states that her daughter received the varicella vaccine in 1995 and came down with this disease on 1/1/01. Y 10/30/1995 01/01/2001 1890 NONE PVT UNK NONE NONE NONE 1
0165957 02/16/2001 MD 11.0 5 M 02/02/2001 Mother states that her son received the varicella vaccine in 1995 and came down with the chickenpox on 1/17/01. Mother states that her son had over 120 pox. Y 11/02/1995 01/17/2001 1903 NONE PVT OTH NONE NONE NONE 1
0165958 02/16/2001 NM 1.0 F 01/30/2001 Rash and fever for 3 days after receiving shots, 1 week earlier. Seen in ER X 1 and then by pediatrician. Y U 01/19/2001 01/30/2001 11 UNK UNK NONE 1
0165959 02/16/2001 ID 38.0 36 F 01/30/2001 Called on 1/24/01, eyes swollen, took Sudafed and are still puffy. Called client on 1/25/01 and left eyelid better, right eyelid worse. On 1/30/01, some puffiness on eyelids but much better. Plans to get #2 Hep-B shot. Y 01/23/2001 01/24/2001 1 PUB UNK PPD/Connaught/C0048AA/LFA; oral contraceptive (long pink pack); vitamins Trace of head cold Allergy to codeine ID01005 1
0165960 02/16/2001 NY 17.0 17 M 01/10/2001 Two hours, post vax, pt felt light-headed which lasted about 1/2 hour. At the same time, pt's right arm and leg felt tingly, lasting about 3 hours. In the AM of 12/28/00, woke up with right arm and leg feeling tingly, progressing to numbness in the right hand and foot. Numbness persisted until around 12/31/00. Pt still has periodic numbness on top of right foot. N 12/27/2000 12/27/2000 0 PUB PUB NONE NONE Allergy to Benadryl NYS21007 1
0165961 02/16/2001 NY 1.4 1 .5 F 01/02/2001 Mother reported "hive" on left cheek 1/2 hour, post vax. Hive on left leg and smaller hives later. Fever to 100.5F, fussy and "itchy". Fever up to 101.8F, the following day. No further problem. Y 11/21/2000 11/21/2000 0 PUB UNK Enlarged lymph node behind left ear NONE NYS21002 1
0165962 02/16/2001 NY 1.25 1 .3 M 01/12/2001 Mother reported left thigh was red and swollen at site of injection; he had trouble breathing on the 4th day, post vax, though the 6th day; hives starting on 5th day, post vax and continuing through to the 6th day; vomiting and loss of appetite from the 4th to 6th day, post vax. Took to health center on day 6, 1/11/01. Y Y 01/05/2001 01/09/2001 4 NONE UNK PUB Albuterol via nebulizer prn Cold beginning Sepsis at birth; respiratory problems last year. NYS21001 1
0165963 02/16/2001 TX 3.0 1 .8 M 02/08/2001 Pt came down with chickenpox after receiving varicella vaccine. Y 01/15/1999 02/08/2001 755 PVT PVT NONE NONE 1
0165964 02/16/2001 NJ 4.0 4 F 02/02/2001 Arm from just above the elbow to the top of her shoulder, became red, swollen, indurated but not tender within 24 hours, post vax. Had a fever, 3 days, post vax, and an URI. Y 01/30/2001 01/31/2001 1 NONE PVT PVT NONE 1
0165965 02/16/2001 KY 1.25 1 .3 M 02/08/2001 No reaction at the time of immunizations. Went to doctor the next day with his right leg swollen, red and with increased warmth. This is contained above the knee. The leg does not appear tender. He has been running a low-grade fever. He has had a clear runny nose. Appetite is good, but fussier than usual. Dx'd with a reaction to shots. If the child worsens or develops fever, mother is to call. Mother called on Saturday morning and said child's fever spiked to 102F. She was going to bring him over so I could recheck him, but when I called back in the afternoon, father said the fever had resolved. It was down below 100F, he was much better, leg was less swollen and they felt he would do well. Y Y 02/01/2001 02/02/2001 1 PUB PUB NONE NONE Allergies to shell fish. KY2001011 1
0165966 02/16/2001 CA 2.0 2 .5 F 02/09/2001 Pt had red spots on left thigh but decreasing. Induration over 24 hours. Mom noted "red bump" 2/6/01 on left upper thigh. Increased in size during next 12 hours. Hot, firm to touch. No elevation in temperature. Full range of motion of both legs. Area showed improvement as of 2/11/01 with no residual sequellae. Y 02/05/2001 02/06/2001 1 NONE PVT PUB NONE Limp right leg-all work ups-neg 1
0165968 02/16/2001 MS 43.0 43 F 02/15/2001 Fatigue, severe migrating arthralgias and myalgias (sometimes with swelling and erythema) for the past 9 months. Have tried NSAIDS and steroid injections. Follow up 06/04/2001: "Patient has not recovered from adverse event. Fatigue, migrating joing, muscle pain, confusion, digestive problems, light-headed, ears ringing... 35-40 days plus several days left work early or come in late." N 10/24/1999 11/01/1999 8 RF-1:320; ESR-3; Bone Scan-mild arthritic type changes MIL MIL Norvasc NONE HTN 1
0165969 02/20/2001 MD 0.5 0 .5 M 12/29/2000 The pt died one week after receiving immunizations. Y 12/20/2000 N 12/13/2000 12/20/2000 7 PVT UNK NONE heart disorder 1
0165970 02/20/2001 FL 69.0 69 M 02/13/2001 Received phone from from daughter of pt requesting manufacturer and lot number. Stated that her father died at 8:30 PM the day he received the flu vaccine from a heart aneurysm. Y 11/15/2000 N 11/15/2000 11/15/2000 0 OTH PVT NONE 1
0165972 02/20/2001 CA 39.0 39 M 02/15/2001 It was reported that a 39 year old male pt received IPOL and HEP-B (2nd dose) on 6/11/99 for travel. The pt started with "severe pain and burning in all four limbs and trunk, tremors, fatigue" on 6/17/99. Dx'd as small fiber neuropathy. Pt was treated with Prednisone. The pt had received other travel vaccines on 5/5/99. Pt was evaluated at hospital. New being followed at another hospital. Reportedly, modified work schedule. Pt under care of a Neurologist. Further information is requested. Y Y U 06/11/1999 06/17/1999 6 spinal taps, EEG, EMG, EKG, MRI - results not provided UNK UNK U2001004130 1
0165974 02/20/2001 FL 1.2 F 02/14/2001 Information has been received from a physician concerning a 14 month old female with failure to thrive and possible immunodeficiency who on approx. 1/16/01, was vaccinated with MMR II. On approx. 1/23/01, the pt experienced encephalitis, seizures and immune deficiency (that could have possibly been present prior to vaccination). The encephalitis, seizures and immune deficiency required hospitalization. At the time of the report (2/6/01), a spinal tap was pending. The pt's hospitalization continued and the pt was noted to be in poor condition. Additional information has been requested. Follow-up states the pt has died. Y Y Y N 01/16/2001 01/23/2001 7 spinal tap - pending UNK UNK UNK failure to thrive, immunodeficiency WAES01020506 1
0165976 02/20/2001 CA 70.0 U 02/08/2001 On 01/28, this patient had progressive weakness of the lower extremities, aching and pain of lower extremities, numbness, and difficulty walking. The symptoms have been ongoing for 3 months. Y Y Y Y N Guillain Barre Syndrome UNK UNK myelodysplastic syndrome 1
0165977 02/20/2001 CA 77.0 75 M 02/08/2001 On 01/19, this patient had weakness in all extremities and inability to walk. Diagnosis - Acute Guillain Barre' Syndrome. Y Y Y Y N 12/01/2000 01/19/2001 49 MIL UNK NONE allergy to ASA 1
0165978 02/20/2001 CA 71.0 71 F 02/08/2001 On 12/08/00, this patient had a sudden onset of numbness and weakness. Diagnosed with Guillain Barre' Syndrome. The follow-up reports state hypertension, arthritis, leg cramps cataract surgery benign breast tumor, appendectomy before the onset of GBS symptoms as ongoing medical conditions. And prior to the onset of GBS symptoms, the pt also experienced headache. Y Y Y Y N 11/03/2000 12/08/2000 35 PVT PVT NONE NONE 1
0165979 02/20/2001 MN 73.0 73 M 02/15/2001 Following vaccination the pt's family noticed a sudden onset of confusion and mental deterioration in 1/99. A rapid progression from short-term memory loss to death in March 2000. A diagnosis of paraneoplastic disorder was given. Further information is requested. Y N 10/21/1998 01/01/1999 72 UNK UNK U2001004120 1
0165980 02/20/2001 ME 1.3 1 .3 F 02/15/2001 On 1/31/01, parents reported fever and rash and temperature of 106.1F with red/pink, slightly raised rash on neck, head, abdomen and back. Seen by provider on 2/3/01 and child had extensive maculopapular rash on abdomen, chest and back. Physician's impression is viremia per blood culture done. Given Rocephin but results were no growth after 5 days. Y Y 01/23/2001 01/31/2001 8 WBC on 2/2/01-16.1; blood culture-viremia PVT PUB NONE NONE NONE ME01005 1
0165981 02/20/2001 ME 1.75 1 .7 M 02/15/2001 Irritable, crying and won't sleep. This is out of character, per mom. None or questionable fever. Recheck with child's parent on 2/15/01; child is getting back to normal and is playful. U 02/14/2001 02/15/2001 1 NONE PVT PUB NONE NONE NONE ME01004 1
0165982 02/20/2001 MD 53.0 53 M 02/10/2001 Referred to Rheumatologist on 4/26/00 for 1st appt. Has been seen by them on 6/5/00, 9/11/00 and 12/11/00. Pt taking Prednisone, currently. Next scheduled appt. is 3/5/01. U 09/24/1999 PVT UNK 1
0165983 02/20/2001 NJ 0.8 0 .9 M 02/12/2001 Swelling of hands and feet which occurred the same day the pt received Prevnar vaccine; resolved without treatment in 24-48 hours. Y Y 02/02/2001 02/02/2001 0 PVT OTH NONE NONE 36 week twin 1
0165984 02/20/2001 CT 36.0 34 M 02/13/2001 Vaccine is believed to have triggered my severe and chronic case of Lyme disease. I've been sick for 1 1/2 years. Symptoms include; sleep disorder, headaches, fatigue, nausea, neck and shoulder pain, depression and anxiety. Y N 04/01/1999 06/01/1999 61 Western Blot-showed many 'bands' related to Lyme OTH OTH NONE 1
0165985 02/20/2001 CT 1.25 1 .3 F 02/12/2001 Woke up next morning with a temperature of 103F, fussy, clingy and acting spacy. 2 days later, had red and warm spot on right thigh and continued temperature. Seen in office on 2/12/00. No temperature; no rash and is better. Y Y 02/08/2001 02/09/2001 1 PVT PVT NONE NONE 1
0165986 02/20/2001 PA 42.0 40 F 02/12/2001 General feeling of aching all over, tiredness, trouble sleeping and problem with bursitis in left foot (hardly ever stops hurting). Hands aching and an all over feeling of lousiness. Treated with cortisone shots and is seeing doctor for further testing. N 06/01/1999 PVT OTH Synthroid, Zoloft, Claritin NONE Tetracycline and sulfa allergies; Prolactinoma; Thyroid 1
0165987 02/20/2001 GA 0.5 10 F 01/31/2001 Fever of 104F and fussiness. Y Y 01/30/2001 01/30/2001 0 NONE PVT PUB NONE NONE NONE 1
0165988 02/20/2001 NY 65.0 65 F 11/22/2000 Puffy arm and red from elbow to shoulder. Y 11/15/2000 11/16/2000 1 PUB PUB NY521005 1
0165989 02/20/2001 NY 83.0 83 F Thursday and Friday had a sore arm. Saturday, muscles ached and arm was red and hot from shoulder to elbow. States allergic to eggs, but eats baked products with eggs and eats 1 egg a week. Y 11/30/2000 12/01/2000 1 PUB PUB Cardiac only Allergy to eggs NY521003 1
0165990 02/20/2001 SC 57.0 77 M 01/12/2001 Pt stated his left arm felt "tight" about 21:00 on 1/11/01. No complaint of pain or fever but did have some difficulty raising left arm to face. Left elbow area was red, ward to touch and swollen approx. 3/4 larger than the right elbow. Checked by doctor, who recommended Benadryl. Also advised to take Tylenol if needed. Keep left arm elevated when in bed and use warm compresses. Y 01/11/2001 01/11/2001 0 NONE PUB PUB Clonidine, imipramine, Prevacid, Kacodex, Metroproterenol, Menacycline Gastric Ulcer, surgeries for aortic (1996) and abdominal (1998) aneurysms SC0102 1
0165991 02/20/2001 SC 65.0 65 F 01/03/2001 Pt complaining of "burning pain" around neck, jaw and both collar bones. Upset stomach with nausea and vomiting, "heart pounding" and shortness of breath. Pt instructed not to take flu shots in the future. Y 12/07/2000 12/07/2000 0 NONE PUB UNK NONE SC00092 1
0165992 02/20/2001 SC 59.0 59 F 01/04/2001 Pt noticed, 3 days ago, that right arm deltoid muscle area began itching. Has 2 areas approx. 2 1/2" below site of Tetanus that is red and slightly warm feeling and "looks better than they did; were almost red". Possible allergic reaction to TD vaccine. Y 12/27/2000 01/01/2001 5 NONE PUB PUB BP medicine and Estrogen NONE HTN SC0101 1
0165994 02/20/2001 OR 2.0 2 .1 M 02/15/2001 On 2/5/01 at 11:35, mom called stating he had leg pain and pt was walking on leg. No fever , redness or swelling but was warm consistently. Gave him Motrin. On 2/7/01 at 16:05, mom removed bandaid from injection site on left leg and under bandaid it looks red and with pus; no redness around bandaid site. Advised to go to urgent care facility. Urgent care doctor told to apply Bactroban ointment and use warm compresses to site. Y U 01/25/2001 02/05/2001 11 PVT OTH NONE NONE NONE 1
0165995 02/20/2001 NJ 1.5 1 .5 M 02/02/2001 Arm from just above elbow to shoulder became red, swollen, warm and indurated but not painful. Y 02/01/2001 02/02/2001 1 PVT PVT NONE NONE NONE 1
0165996 02/20/2001 FL 1.0 1 .0 F 02/12/2001 On 2/10/01, rash started on trunk (red and raised) and progressed to entire body. On 2/11/01, facial swelling and knees swelling. Took to ER and was dx'd with urticaria. Placed on Prelone and Atarax. Y Y 02/08/2001 02/10/2001 2 PVT UNK NONE Mild URI NONE 1
0165997 02/20/2001 AR 5.0 5 F 02/09/2001 Vomiting and blotching of palms. Redness noted on feet and in face. At 15:00, doing well. At 17:00, resting. Y 02/09/2001 02/09/2001 0 PVT PUB NONE 1
0165998 02/20/2001 ND 12.0 12 F 11/14/2000 Pt had generalized rash involving shoulder and upper arm of injection arm. Rx'd OTC Caladryl lotion. Y U 11/08/2000 11/10/2000 2 OTH PUB NONE ND0016 1
0165999 02/20/2001 MN 6.0 2 .3 F 02/08/2001 Developed chickenpox on 4/6/98, unknown length of illness. Developed chickenpox again on 1/22/01. Supportive care. Y Y 05/23/1997 01/22/2001 1340 Observation PVT PVT NONE NONE Infection and no drug effect~Varicella (Varivax)~~3.20~In Patient 1
0166000 02/20/2001 MN 34.0 30 M 02/08/2001 Pt developed chickenpox with a duration of about 7 days. Treated with Famvir 500mg X 10 days; Benadryl and Calamine. Y Y 05/23/1997 01/20/2001 1338 NONE PVT PVT NONE Environmental allergies. 1
0166001 02/20/2001 GA 1.3 1 .3 F Involuntary body jerking, episodic, with onset approx. 14 hours, post vax. Duration of shaking symptoms, 1 second. Occurrence was 1-4 times a minute. Duration of total episodes about 1 1/2-2 hours. Y 02/06/2001 02/07/2001 1 PVT UNK Tylenol Cold and fever NONE 1
0166002 02/20/2001 PA 32.0 32 F 02/13/2001 Vaccine given 2/2/01. Pt developed acne-like rash on face and generalized itchy, tingly skin on 2/9/01. Pt was instructed to use Benadryl and call office if not improved. Y 02/02/2001 02/09/2001 7 PVT PVT NONE 1
0166003 02/20/2001 MN 21.0 20 F 02/12/2001 Weakness, fatigue, mono-like symptoms X 7 days, following each vaccine. Pt recovered. Y 08/24/2000 08/31/2000 7 NONE PUB PUB Ortho-Tri-Cyclen NONE Allergies to codeine and bilateral knee pain 1
0166004 02/21/2001 NY 0.2 0 .2 F 01/23/2001 7 days, post vax, child brought in by mom, secondary to being irritable and swelling in left thigh and pain upon movement and cellulitis; started on IV antibiotics and Benadryl in hospital for 2 days. Had a fever of 101.8F; indurated area of cellulitis in thigh 1cm X 1 1/2cm; responded to antibiotics. Discharged home. Y 2 Y 12/18/2000 12/25/2000 7 PVT PVT Synagis Cellulitis Premature at 34 weeks 1
0166005 02/21/2001 GA 2.0 0 .7 M 02/15/2001 A father reported that his 24 month old son received an injection of Tri-Immunol in 1988 and subsequently, developed a fever and a knot at the injection site. One week, post vax, he was admitted to the hospital; he received a spinal tap and was dx'd with viral meningitis. The child was later dx'd as having mild mental retardation. Follow-up information received from a healthcare provider on 3/8/01, idicated that the child received Tri-Immunol and Orimune on 8/20/87. On 8/23/87, he developed an abscess at the injection site. He was admitted to the hospital and the abscess drained. A culture was positive for Haemophilus influenzae B. He was discharged after 7 days. The abscess resolved by 9/7/87. A psychological report also received on 3/8/01, indicated that the child was tested to be within the mentally deficient range with associated impairment in adaptive behavior. Y 7 Y U 08/20/1987 08/23/1987 3 Lumber Puncture-pending; Culture wound-positive for Haemophilus influenzae B PUB PUB UNK NONE UNK HQ7230414FEB2001 1
0166012 02/21/2001 OH 2.0 2 .7 U 01/12/2001 True vertigo. Pt states "I'm falling" and grabs onto something for stability. States "the trees are falling on me". Pt trips "as if drunk"; onset 24 hours after Prevnar. Symptoms lasted until 1/17/01. N 01/09/2001 01/10/2001 1 NONE PVT UNK NONE NONE 1
0166013 02/21/2001 NY F 02/16/2001 Within a week of the 2nd vaccine, the pt started to "feel less well." She was aching, tired, "gloomy of outlook" and "too exhausted to go to the gym". Her arthritic symptoms became worse. In late May, the symptoms of numbness, and wide-spread tingling returned. She was seen by a neurologist. The neurologist reportedly said that he thinks she has and antibody reaction to the vaccine. Apparently he feels that the antibodies in the vaccine have triggered her body to be overactive in its production of antibodies and so they are not content with attacking the bad guys, but are also attacking the nerves and joints. She self-medicated with round the clock ibuprofen for two weeks. The ibuprofen partially alleviated the arthritic symptoms but did not relieve the numbness and tingling. As of 2/1/01, the outcome of these events is unknown. Y U 04/01/1999 04/08/1999 7 Lyme ELISA - pos, Lyme Western blot - neg, MRI - nml OTH OTH aching joints, arthritic symptoms, Bells Palsy, cognitive deficits, depressed, dyslexic, fatigue, headache, hysterectomy, Lyme disease, Lyme hepatitis, neuropathy, numbness, palpitations, post Lyme Fibromyalgia, psychological deficits, rash, sinus infections, suicidal, tingling 20010036201 1
0166014 02/21/2001 PA 68.0 67 M 03/21/2001 Report 2001003926-1 describes rheumatoid arthritis in a 68 year old male who received Lyme disease vaccine. This report was received from the patient and has not been verified by a physician or other health care professional. This patient is a avis hunter and fisher. He received his first injection of Lymerix on 04/14/99, no adverse experience was reported following the receipt of this injection. He received his second injection of Lymerix on 05/19/99. By 08/99, approximately three months following the second injection, the joints in the patient's fingers and wrists became "extremely" swollen. In 10/99, the patient was seen by a neurologist, who performed unspecified test and x-rays to rule out carpal tunnel syndrome; the results of these procedures were not provided. The neurologist referred the patient to an orthopedic physician. The patient was seen by the orthopedist in 11/99, at which time Lidocaine was injected into the patient's hand. This provided no relief. The orthopedist referred the patient to a physiatrist, who conducted motor nerve conduction tests and unspecified muscle tests. The physiatrist made a cast and brace for the patient's right hand and prescribed physical therapy. The patient received physical therapy twice weekly from 12/99 through 04/00. The patient stated, "My hands were still swollen so much I could not tie my shoestrings of brush my teeth and were extremely painful". The patient received his third injection of Lymerix in 07/00. The patient's hands and wrists became "worse than ever". He was seen by his internist. A diagnosis of rheumatoid arthritis was reportedly made and the patient was referred to a rheumatologist, who prescribed Medrol. As of 02/01/01, the patient stated, "I never had RA before. However, due to the Lyme vaccine, my blood work showed a RA factor of 95, which should have been 20." The adverse event of rheumatoid arthritis does not meet ICH serious criteria, but is being submitted as an expedited report by special FDA request per the 06/28/00 letter. Y N 05/19/1999 08/01/1999 74 Antinuclear antibody titer 08/30/00 - Neg. Rheumatoid Factor 08/30/00 - 95 OTH OTH 20010039261 1
0166015 02/21/2001 MO 51.0 51 M 02/12/2001 This patient had a Influenza vaccine 01/26/01 (Friday), woke up (Sunday) 01/28/01, with numbness and cold sensation in feet and legs. Progressively increased upward to the waist over a weeks time. Describes current numbness as "80%" numb from waist down. Is seeking medical care from 2 physicians. MRI is scheduled. Y N 01/26/2001 01/28/2001 2 NONE PUB PVT NONE NONE Allergies to Sulfa and Penicillin. 1
0166016 02/21/2001 CA U 08/28/2000 A pharmacist reported that a patient received an injection on 08/18/00 and subsequently developed a "mild" anaphylactic reaction. The reporter also indicated that the patient has an allergy to horses. This report is considered medically important. No further information was available at the date of this report. U 08/17/2000 UNK OTH OTH UNK UNK Hypersensitivity NOS HQ0016218AUG2000 1
0166017 02/21/2001 NC 7.0 M 01/11/2000 A sister reported that her 7 year old brother received an injection of tetanus toxoid for a head wound in 1959 and reportedly developed complete paralysis from head to toes. He was hospitalized where a diagnosis of Guillain Barre Syndrome was made. The pt was intermittently hospitalized over 3 years. As of 1/5/00, no further information was available. Y U UNK OTH OTH UNK Head Wound UNK Numbness in his elbows and legs, shortness of breath, falling and incoordination.~Tetanus Toxoid (no brand name)~1~47.00~In Pati HQ0335706JAN2000 1
0166018 02/21/2001 TX 40.0 F 11/09/2000 nurse reported that a 60 year old female received an injection approximately 20 years ago and subsequently experienced an anaphylactic reaction. The reporter stated that the patient was told that the reaction was "related to an allergy to horse serum". She recovered. This event is considered medically important. Y Y UNK OTH OTH UNK UNK UNK 1948309 1
0166019 02/21/2001 CA U 05/30/2000 A pharmacist reported that a patient received a tetanus injection 44 years ago and experienced an anaphylactic reaction. The patient recovered. As of May 24, 2000, no further information was available. This event is considered medically important. Y UNK OTH OTH UNK UNK UNK HQ6470525MAY2000 1
0166020 02/21/2001 TX F 10/16/2000 A physician reported that a female, now 42 years of age, received an injection of Tetanus Toxoid approximately 20 years ago and subsequently developed a rash and puffy eyes. She recovered. Y UNK OTH OTH UNK UNK UNK HQ0198223AUG2000 1
0166021 02/21/2001 NC 46.0 46 M 01/10/2000 A sister reported that her 46 year old brother received an injection of Tetanus Toxoid absorbed in 04/99 for a head wound. He subsequently experienced numbness of his elbows and legs, shortness of breath, falling, loss of balance an incoordination. As of 01/05/00, no further info was available. U 04/01/1999 UNK OTH OTH UNK Head wound UNK Guillain Barre' Syndrome~Tetanus Toxoid (no brand name)~1~7.00~In Patient 03454707 1
0166022 02/21/2001 CO 71.0 69 F 06/21/2000 A 71 year old female reported that she received an injection of Tetanus Toxoid Adsorbed, on 09/15/98 and a few days later, reportedly developed a red, itchy rash "all over" her back and arms. The patient reportedly recovered within 10 days. Additional information received from the physician on 05/24/00 indicated that the date of vaccine administration was 09/15/98, and the onset of the erythematous rash was 09/23/00. The patient remained recovered. Manufacturer's Comment: The lot # was reported as 0918970; however, this is not a valid Lederle lot number. Y 09/15/1998 09/23/1998 8 UNK PVT OTH Multivitamins Plain, St John's Wart, Thyroid. NONE Hypothyroidism, Breast cancer female nos. HQ0721926JAN2000 1
0166023 02/21/2001 MS 53.0 53 F 04/18/2000 A53 year old female inadvertently received an injection of Tetanus Toxoid Adsorbed, on 01/31/00, instead of PPD. That same day, she developed an injection site reaction characterized by redness and swelling. She was treated with Benadryl. U 01/31/2000 01/31/2000 0 UNK PUB OTH UNK NONE UNK HQ0847601FEB2000 1
0166024 02/21/2001 F 12/15/2000 A female reported that she received an injection of Tetanus Toxoid Adsorbed, and subsequently developed a fever, sore throat, and swollen lymph nodes. The patient considered this to be a serum sickness like reaction. The reporter declined to provide additional information and declined to grant permission for the follow up investigation. U UNK OTH OTH UNK UNK UNK HQ0904312SEP2000 1
0166025 02/21/2001 OH M 07/20/2000 A pharmacist reported that a male received an injection of Tetanus Toxoid 25 to 30 years ago and developed an unspecified reaction. He recovered. No further info was available at the date of this report. Y UNK OTH OTH UNK UNK UNK HQ1155022FEB2000 1
0166026 02/21/2001 PA F 03/27/2000 A pharmacist reported that a female received Tetanus Toxoid adsorbed, 25 years ago and subsequently, developed and unspecific reaction. The patient recovered. As of 03/09/00, no further information was available. Y UNK OTH OTH UNK UNK UNK HQ1486109MAR2000 1
0166027 02/21/2001 WV 40.0 F 10/25/2000 A patient, now 50 years of age, reported that she received an injection of Tetanus Toxoid 10 years ago and subsequently developed shaking and tremors. She also developed a runny nose, cough, grey tongue, sore throat, anorexia, insomnia, weakness, right temple pain, "extreme" anxiety, headache, "cracking and popping" in her head and ears, palpitations, and her right ear had "sensitive hearing". She recovered. Y OTH OTH UNK UNK UNK runny nose, cough, grey tongue, sore throat, anorexia, insomnia, weakness, right temple pain, anxiety, headache, palpitations, s HQ1584629SEP2000 1
0166028 02/21/2001 IL F 04/20/2000 A nurse reported that a female inadvertently received Tetanus Toxoid Adsorbed, or Tetanus and Diphtheria Toxoids Adsorbed, intradermally, instead of PPD. The patient experienced a sterile abscess at the injection site and a rash surrounding the area of induration. The patient was seen by a physician and the sterile abscess was excised. A topical steroid was prescribed for the rash. U UNK OTH OTH UNK UNK UNK HQ1721021MAR2000 1
0166029 02/21/2001 AZ F 10/26/2000 A female, now 64 years of age, reported that she received an injection of Tetanus Toxoid Adsorbed, more than 20 years ago. Subsequently, she became "very ill" and was "in bed for a week". She also developed swelling at the injection site. The reporter indicated that her arm swelled "3 times the size". She recovered. Y OTH OTH UNK NONE Asthma 198461 1
0166030 02/21/2001 FL U 01/24/2001 A nurse reported that a patient inadvertently received an intradermal injection of Tetanus Toxoid Adsorbed and subsequently developed redness at the site of the injection. No further info was available at the date of this report. This is 1 of 2 patients from this facility who experienced this event following receipt of an intradermal injection of Tetanus Toxoid. U UNK OTH OTH UNK UNK UNK HQ2654123OCT2000 1
0166031 02/21/2001 NY 49.0 F 01/09/2001 A pharmacist reported that a female, now 66 years of age, received an injection site reaction of Tetanus Toxoid in 1983. Immediately post-immunization, she developed a fever and an injection site reaction characterized by swelling and pain that extended from her fingertips up through her arm. She recovered after 5 to 6 days. Y UNK PVT OTH NONE UNK UNK Fever and an injection site reaction characterized by pain and swelling~Tetanus Toxoid (no brand name)~~19.00~In Patient HQ2757125OCT2000 1
0166032 02/21/2001 VA 43.0 42 F 01/25/2001 A nurse reported that a 43 year old female received an injection of Tetanus Toxoid Adsorbed, on 10/23/00 for a puncture wound. On 10/25/00, she developed an injection site reaction characterized by pain, swelling and "knots" under her arm. As of 10/27/00 , the pain and swelling had resolved. Y 10/23/2000 10/25/2000 2 UNK OTH OTH UNK Puncture wound UNK HQ2940530OCT2000 1
0166033 02/21/2001 IN 40.0 40 M 01/08/2001 A nurse reported that a 40 year old male inadvertently received an injection of Tetanus Toxoid Adsorbed, on 11/06/00, instead of an IM injection and that day, he developed an injection site reaction characterized by pain and swelling of his forearm. As of 11/07/00, his symptoms persisted. U 11/06/2000 11/06/2000 0 UNK PUB OTH NONE NONE UNK HQ3386508NOV2000 1
0166034 02/21/2001 KY U 05/30/2000 A physician reported that a patient received an injection of Tetanus Toxoid Adsorbed, more than 10 years ago. One week post-immunization, the patient developed progressive axillary and cervical lymphadenopathy which continued for 3 to 5 days. No further info was available at the date of this report. Y UNK OTH OTH UNK UNK UNK HQ3710219APR2000 1
0166035 02/21/2001 IN U 01/08/2001 A physician reported that he treated several patients who inadvertently received Tetanus Toxoid subcutaneously at an unknown facility. The patients experienced injection site reactions characterized by redness, swelling and induration. As of 11/16/00, no further information was available. MANUFACTURER'S COMMENT: The reporter was unable to specify the number of patients who experienced this event. Additional reports will be generated when identifying information is provided. U UNK OTH OTH UNK UNK UNK HQ3852917NOV2000 1
0166037 02/21/2001 OH 19.0 F 01/10/2001 A pharmacist reported that a female, now 66 years of age, received an injection of Tetanus toxoid in 1953. Immediately post-immunization, she developed a fever and an injection site reaction characterized by swelling and pain that extended from her fingertips up through her arm. She recovered after 5 to 6 days. Y UNK MIL MIL NONE UNK UNK Fever, injection site reaction, characterized by pain and swelling.~Tetanus Toxoid (no brand name)~~49.00~In Patient HQ4112127NOV2000 1
0166038 02/21/2001 NC F 06/14/2000 A nurse reported that a female patient received an injection of Tetanus Toxoid Adsorbed, in 1990 and, "a couple of days after injection", developed an injection site reaction characterized by mild to moderate redness and swelling. The patient was subsequently seen by a physician; she required no medical treatment. Y U UNK PVT PVT UNK NONE UNK HQ4176222APR2000 1
0166039 02/21/2001 NY U 01/08/2001 A pharmacist reported that a patient received an injection of Tetanus Toxoid. Subsequently, the patient developed erythema at the injection site. No further info was available at the date of this report. U UNK OTH OTH UNK UNK UNK HQ4882414DEC2000 1
0166040 02/21/2001 ND 66.0 65 M 06/27/2000 A medical assistant reported that a 66 year old male patient received an injection of Tetanus Toxoid in June 1999. In January, 2000, the patient developed an abscess at the injection site which was treated with antibiotics and Bactroban. Y N 06/01/1999 01/01/2000 214 PVT OTH Trazodone NONE UNK HQ5714311MAY2000 1
0166041 02/21/2001 MA F 07/20/2000 A female patient reported she received an injection of Tetanus Toxoid in 1986, and subsequently developed hypertension and chest tightness. The patient recovered. Y UNK OTH OTH UNK UNK Asthma HQ5880415MAY2000 1
0166043 02/21/2001 AK M 08/31/2000 A nurse reported that an adult male, now 67 years of age, received an injection of Tetanus Toxoid in 1971. He subsequently became "bedridden for 4 days and almost comatose". He recovered. Y UNK OTH OTH UNK UNK UNK HQ6148719MAY2000 1
0166044 02/21/2001 IN 20.0 20 M 01/29/2001 A nurse reported that a 20 year old male inadvertently received an injection of Tetanus Toxoid on 11/14/00 and immediately, developed an injection site reaction characterized by redness, swelling, pain and induration. On 05/16/00, he returned to the clinic and was instructed to apply cold packs to the site and self-administer extra strength acetaminophen for pain. The patient was again seen at the clinic on 05/21/00 and had recovered. This is 1 of 5 patients from this facility who was administered Tetanus Toxoid intradermally. Y Y 11/14/2000 11/14/2000 0 NONE OTH OTH UNK UNK UNK HQ6376125JAN2001 1
0166045 02/21/2001 IN 46.0 46 M 02/23/2001 A 46 year old male inadvertently received an injection of Tetanus Toxoid on 11/14/00 and immediately, developed an injection site reaction characterized by redness, swelling, pain and induration. On 11/16/00, he returned to the clinic and was instructed to apply cold packs and to self-administer extra strength acetaminophen for the pain. The patient was seen again on 11/20/00 and he recovered. This is 1 of 5 patients from this facility who was administered Tetanus Toxoid intradermally. Y Y 11/14/2000 11/14/2000 0 NONE OTH OTH UNK UNK UNK HQ6376225JAN2001 1
0166046 02/21/2001 WV M 06/27/2000 The wife of a male, who had been in his 20's reported that her husband received an injection of Tetanus Toxoid 8 to 10 years ago and experienced "general malaise" which lasted approximately 10 months. Y UNK OTH OTH UNK UNK UNK HQ6644431MAY2000 1
0166047 02/21/2001 MI 17.0 17 F 07/20/2000 A mother reported that her 17 year old daughter received an injection of Tetanus Toxoid Adsorbed, on 05/30/00 and subsequently developed pain in the joints of her fingers, wrists, and knees. The patient's previous dose of Tetanus Toxoid was administered in 1998. U 05/30/2000 UNK PVT OTH Tetracycline, Tuberculin PPD UNK Acne nos HQ6854205JUN2000 1
0166048 02/21/2001 IL 28.0 F 07/20/2000 A nurse reported that a female, now 48 years of age, received an injection of Tetanus and Diphtheria Toxoids Adsorbed, 20 years ago and subsequently developed flu-like symptoms. She also developed a 6 inch wheal at the injection site. She recovered. Y UNK OTH OTH UNK UNK UNK HQ6932806JUN2000 1
0166049 02/21/2001 OH 33.0 33 F 10/03/2000 A 33 year old female reported that she received an injection of Tetanus Toxoid Adsorbed, on 07/24/00. A few days after vaccine administration, she developed an injection site reaction characterized by redness and pain. She states she was unable to raise her arm above her head. She also experienced generalized weakness. She recovered after 5 to 6 days. Y 07/24/2000 UNK PVT OTH UNK UNK UNK HQ9805014AUG2000 1
0166050 02/21/2001 CT U 03/24/2000 A pharmacist reported that an unidentified patient received an injection of Tetanus Toxoid 20 years ago and subsequently developed an allergic reaction. The patient recovered. Y UNK OTH OTH UNK UNK UNK HQ1106417FEB2000 1
0166051 02/21/2001 OH F 05/12/2000 A pharmacist reported that a female received an injection of Tetanus Toxoid Adsorbed, on 02/29/00. On 03/01/00, the patient developed an injection site reaction characterized by induration, erythema and tenderness. Additional info received 05/09/00 indicated that the patient recovered. Y Y 02/29/2000 03/01/2000 1 UNK PVT OTH UNK UNK UNK HQ1354403MAR2000 1
0166052 02/21/2001 WI 43.0 43 F 07/20/2000 Physician reports a 43 year old women received injection of Tetanus Toxoid Adsorbed, Purogenated on march 14, 2000. Physician reports pt developed pain at the injection site. The patient did not require medical treatment. The pt's last dose of tetanus toxoid was administered in 1990. This is 1 of 3 patients from this facility who developed an injection site reaction following receipt of Tetanus Toxoid Adsorbed, Purogenated lot 462-809. U 03/14/2000 03/15/2000 1 UNKNOWN PVT PUB Alesse-28, Fexofenadine Hydrochloide NONE UNKNOWN HQ1983131MAR2000 1
0166053 02/21/2001 CA F 12/20/2000 A nurse reported that an adult female received and injection of tetanus toxoid (manufacturer unknown) many years ago and subsequently developed an injection site reaction characterized by swelling, readnessk and hardness. She recovered Y MIL MIL UNK UNK UNK readness,swelling, and hardness~Tetanus Toxoid (no brand name)~~0.00~In Patient HQ2236514OCT2000 1
0166055 02/21/2001 M 05/05/2000 Fever. A healthcare professional reported that a male received an injection of tetanus toxoid adsorbed (manufacturer unknown) 10 to 15 years ago and subsequently developed a fever of 104. He recovered. Y UNK OTH OTH UNK UNK HQ3616218APR2000 1
0166056 02/21/2001 13.0 M 04/25/2000 A pharmacist reported that a 13 year old male received an injection of Tetanus Toxoid Adsorbed, Purogenated. Approximately 6 days post immunization presented to emergency room with a 4cm by 7cm area of redness at the injection site with "central clearing in the middle. On 4/19/2000, the reporter indicated that the redness was resolving. Y U 01/01/2000 04/01/2000 91 UNK PVT OTH NONE UNK UNK HQ4154122APR2000 1
0166057 02/21/2001 1.0 U 10/03/2000 A pharmacist reported a 12 month old patient (currently 78 years old) received an injection of tetanus and diphtheria toxoids (manufacturer unknown) and subsequently developed an allergic reaction. No further information was available at the date of this report. U 01/01/1922 OTH OTH UNK Cat bite Hypersensitivity NOS HQ4198222APR2000 1
0166058 02/21/2001 NC 37.0 F 05/23/2000 A nurse reported that a 37 year old female received a tetanus toxoid adsorbed (manufacturer unknown) around 1990 and subsequently developed a moderate reaction at the injection site. Reporter indicated that the pt was informed to be careful with future injections of tetanus vaccine. Follow-up information received from the reporter on 5/19/2000 provided the date of therapy and event onset. The patient recovered. Y 02/07/1990 OTH OTH UNK UNK UNK HQ4900228APR2000 1
0166059 02/21/2001 F 08/25/2000 a pharmacist reported that a female received an injection of Tetanus Toxoid Adsorbed, Purogenated and subsequently developed an injection site reaction. No further information was available as of the date of this report. U OTH OTH UNK UNK UNK HQ6220322MAY2000 1
0166060 02/21/2001 CA F 08/04/2000 A territory representative reported that she received an injection of tetanus toxoid (manufacturer unknown) and experienced injection site pain. The pain persisted as of 6/06/2000. U 06/01/2000 06/01/2000 0 UNK PVT OTH UNK NONE UNK HQ7180312JUN2000 1
0166061 02/21/2001 WI 40.0 40 F 07/20/2000 A physician reported that a 40 year old female received an injection of Tetanus Toxoid Adsorbed Purogenated on 3/10/2000. On 3/13/2000 pt developed intermittent pain at the injection site which would shoot into her neck and down her arm. Pt treated self with advil. This is 1 of 3 pt from this facility who developed an injection site reaction following receipt of tetanus Toxoid Adsorbed, Purogenated lot 462-809. U 03/10/2000 03/13/2000 3 UNK PVT PVT NONE NONE UNK HQ7297914JUN2000 1
0166062 02/21/2001 WI F 07/20/2000 A physician reported that a female received an injection of Tetanus Toxoid Adsorbed, Purogenated on 3/13/200 or 3/14/2000. Pt subsequently developed an injection site reaction characterized by pain and slight redness. This is 1 of 3 patients from this facility who developed an injection site reaction following receipt of Tetanus Toxoid Adsorbed, Purogenated lot 462-809. U 03/13/2000 UNK PVT PVT UNK UNK UNK HQ7300114JUN2000 1
0166063 02/21/2001 OH 34.0 34 F 12/14/2000 Physician reported a female, now 58 years old, received an injection of tetanus toxoid (manufacturer unknown) in 1976 and subsequently developed hives. Pt recovered. Physician indicated that the pt has multiple allergies, including mold, pollen, dust and others. Pt receives allergy shots. Y 01/01/1976 01/01/1976 0 UNK OTH OTH UNK Stepped on garden tool. Concurrent conditions; Multiple allergies HQ9068727JUL2000 1
0166071 02/22/2001 ME 1.08 1 .1 M 02/13/2001 This patient had post vaccine varicella, complicated by cellulitis and abscess. The patient required incision and drainage, hospitalization, and IV antibiotics. Y 3 Y 01/22/2001 02/08/2001 17 Wound culture grew S. Aureus. PVT PUB NONE NONE 1
0166072 02/22/2001 LA 16.0 15 F 02/07/2001 On 02/05/01, around 3/4 PM, the patient was seen by the pediatrician with complaints that her head feels like turning to the right and shaking all over. No treatment. On 02/06/01, at school she had seizure like symptoms, she was hospitalized. On 02/07/01, thus far 3 seizures within 24 hour since in hospital. Face and neck muscle tremors, she doesn't loose consciousness. Prescribed Dilantin. Referred to neurology. Annual follow up states the following: "On June 5, 2002, a telephone call was made for follow-up on patient who in february of 2001 was experiencing seizures, after receiving adult TD and second dose of Hepatitis B vaccine. I inquired to her mother if patient was having any problem in the last year. She stated she had none. I asked patient's mother if there was a final diagnosis and she said the attending doctors claimed that the seizures were being caused by the patient's mental state. That there was no evidence of an outside medical reason of the seizure. Patient has recovered and has had no other incidents, stated his mother". Y Y Y 02/05/2001 02/05/2001 0 EEG, Drug screen - neg, CT scan - neg PUB PUB NONE NONE LA010201 1
0166073 02/22/2001 CA 1.08 1 .1 M 02/07/2001 The pt was seen on 1/18/01 for gastroenteritis. The pt had follow-up visit on 2/1/01 and received Prevnar. The pt experienced a rash, allergic reaction to Prevnar versus purpura. Y 2 Y 02/01/2001 02/01/2001 0 OTH OTH 1
0166074 02/22/2001 TN 2.0 1 1 M 02/09/2001 The afternoon of the vax, the pt experienced a fever of 100. Tylenol was given prior to receiving the vax. When Mom arrived home from work, the child ate and seemed normal except seemed sleepy. The temp at 20:30 was 99. At 10:00 pm the child was sleepy and began having a seizure. After the seizure the child was unresponsive. The parent called 911. The ambulance arrived approximately 20 minutes later. Mom gave emergency breathing because of shallow breathing. The child was non-responsive for about 25 minutes. Child was given oxygen and brought to local ER and then transferred to another facility. The child stayed in the hospital over night. and was released the following morning. Y Y Y 02/07/2001 02/07/2001 0 CT scan - nml, drug screen - neg PUB UNK Tylenol NONE NONE TN01007 1
0166075 02/22/2001 VA 68.0 67 F 02/11/2001 Within 48 hours the pt complained of crippling pain and swelling of the knees and ankles. The pt was unable to work at first. The pt was treated with Doxycycline, Celebrex and Ultram for 3 months. U 08/22/2000 08/24/2000 2 PVT OTH 1
0166076 02/22/2001 NJ 50.0 M 02/16/2001 In the spring of 2000, the pt experienced left arm pain, which was considered to be non-cardiac in origin. In approximately 4/00, the pt began to experience episodes of intermittent chest pain and dyspnea sometimes with dizziness. The pt was diagnosed with non-cardiac chest pain, clinically insignificant coronary artery disease, and normal left ventricular wall motion. Two-three weeks following the catheterization, the pt had two or three episodes of syncope. A holter monitor was placed on 8/3/00. Analysis of the recording revealed rare supraventricular events scattered throughout the study. The pt was to see a Lyme disease specialist in 8/00. As of 1/31/01 the outcome of these events was unknown. Y U 07/01/2000 SPECT Thallium Scan - nml, Chest CT - nml, chest x-ray - nml, echocardiogram - mild mitral regurgitation, right and left heart catheterization - minor coronary intimal irregularities, OTH OTH Prednisone, Lasix elevated liver function tests, gouty arthritis, mitral regurgitation, positive Hep A antibody titer, pulmonaic regurgitation, tricuspid regurgitation, diffuse ST-T wave abnormalities. 20010027941 1
0166077 02/22/2001 PA 72.0 72 M 03/12/2001 Some time post vax, the pt developed osteoarthritis, burning sensation in esophageal tract. The outcome of these events was not provided. The follow up states this report describes dysesthesia and burning mouth syndrome in a 72 year old male who received Lyme disease vaccine recombinant OspA. Additional info was received as part of litigation proceedings. Medical history included difficulty sleeping, bilateral heel suprus, osteoarthritis of the left knee, degenerative changes of the dorsal spine, gout, benign prostatic hypertrophy, hypercholesterolemia, elevated triglycerides, hypertension, glucose intolerance, elevated lactic dehydrogenase, elevated SGOT, elevated creatine kinase, elevated eosinophil counts, and elevated SGPT. The pt had no known allergies and no history of Lyme disease. Surgical history included tonsillectomy and adenoidectomy and repair of a deviated nasal septum. Family history was significant for his father dying at age 38 and his sister dying at age 56; the pt reported the cause of their deaths as "liver." The pt reported that he jogged three miles per day, six days per week. Concurrent medications included Monopril, colchicine, temazepam at bedtime, Lopid, multivitamin, vitamin E, vitamin C, vitamin B complex, and garlic. Following the reported onset of dysesthesia and burning mouth syndrome, the pt experienced increased serum creainine concentration, suspected prostatitis, first-degree atrioventricular block, a urinary tract infection, ringing in the ears, and abscess and cellulitis around the left knee. These were not reported as adverse events due to vaccine administration, but were found during the course of review of the pt's medical records. Therefore, they are not listed as adverse events. The pt received his first 0.5mL IM injection of LYMErix on 2/11/99. The pt was seen by his primary physician on 2/23/99. At that office visit, the pt reported that he "felt very tense, nervous" after receiving LYMErix, but "feels good now." The pt received his second 0.5mL IM injection ofLYMErix on 3/18/99. No adverse experience was recorded in the vaccine provider's office records following the administration of this injection. The pt received his third 0.5mL IM injection of LYMErix on 4/22/99, two months after the first injection, rather than the recommended interval of 12 months. The reporting physician stated that the pt experienced a burning sensation of the stomach, esophagus, and tongue. The pt was treated with Propulsid, Prevacid, and Carafate, which did not alter his symptoms. On physical examination, it was noted that the pt had a mild right-sided facial droop. Cranial nerves were normal. The physician attributed the burning sensation to a neurologically-caused dysesthesia. The following info was obtained through review of medical records. On 5/21/99, 30 days after the administration of the third injection of LYMErix, the pt was seen by his primary physician with a chief complaint of "stomach burn, nausea, diarrhea, epigastric pain; the pt reported symptom onset on 5/20/99 (29 days post-immunization). The physician made a diagnosis of peptic ulcer disease and prescribed Prevacid 30mg daily. The pt was not seen again by the vaccine provider until 7/15/99; reason for the visit was evaluation of hypertension and hypercholesterolemia. The pt reported that he still experienced "stomach burning sensation." The physician noted, "He is having trouble with indigenstion. He said that the Prevacid has helped before." The physician made a diagnosis of peptic ulcer disease and prescribed Prevacid. The pt was seen by the vaccine provider on 9/20/99 with a chief complaint of epigastric pain. At that time, the pt reported that the burning sensation started following receipt of LYMErix in February 1999. The pt reported that the burning sensation now extended "into throat and mouth." The physician made a diagnosis of gastroesophageal reflux disease and prescribed Aciphex 20mg daily. Antibodies against Helicobacter pylori were measured on 9/29/99: IgG and igM antibodies were negative. The pt was referred to a gastroenterologist. The pt underwent esophagogastroduodenoscopy and colonoscopy on 10/15/99. Mild gastritis, mild duodentiis, and hypertrophy were observed. The gastroenterologist's impressions were "mild gastritis, prepyloric inflammation, hypertrophy." The pt then underwent colonoscopy. One to three diverticulums were identified and three polyps were removed. The gastroenterologist's impression was "Polyps of the right colon." The pathologist's diagnoses, based upon specimens obtained during EGD and colonoscopy were "stomach, antrum: benign hypertrophic gastric mucosa. No H. pylori organisms identified. Colon, proximal cecum: tubular adenoma. Colon, distal cecum: mildly edematous colonic mucosa. Colon ascending: hyperplastic polyp." The pt was seen by his primary physician on 11/4/99. At that time, he reported that the gastroenterologist had prescribed Propulsid 10mg daily, but it was "not helping." The pt stated that he had been experiencing "abdominal pain, burning feeling" since receiving LYMErix in April 1999. On physical examination, the physician observed a ventral hernia when the pt flexed his abdomen. The hernia was "about 3 to 4 inches up from xyphoid to above umbilicus." It was not tender. The physician's assessment was "abdominal pain-secondary to ventral hernia?" An esophagram was performed on 11/8/99. The radiologist's impression was "unremarkable esophagram." Ultrasound ofthe gallbladder was performed on 11/26/99, which "shows a normal appearing gallbladder, which is free of stones. There is also no evidence of bile duct dilatation." The pt was seen by a gaastroenterologist on 11/12/99 for 'evaluation of chronic reflux symptoms." The pt reported that he "has been free of any digestive symptoms until April of htis year after he received the Lyme disease vaccination and subsequently developed heartburn, burping and acid regurgitation, occurs dya and night, not necessarily related to meals, for which he has been treated with antacids, Prevacid and Priolosec in the past with no significant relief. He has been treated with Aciphex and propulsid with marginal relief. His appetite is well maintained. There is no recent histroy of dysphagia, odynophagia, significant abdominal pain, alteration of bowel movement or weight loss. Physical examination in the office is unremarkable including abdominal examiantion." In a letter to the vaccine provider, the gastroenterologist stated "Per phone conversation with the pt on 12/2/99, his reflux symtpoms have been significantly improved while on Aciphex therapy lately." On 11/18/99, the pt underwent an esophageal manometry study and 24 hr pH probe was inserted. THe gastroenterologist's impression of the study was "normal esophageal manometry study." No gastroesophageal reflux was observed with the 24 hr pH probe. The pt was seen by the reporting physician on 1/3/00. At that time, he reported his chief complaint as "acid reflux." He indicated that the pain was a constant burning and was located in his abdomen. On a scale of zero to ten, he reated the pain as "seven to eight." At that time, he also reported ringing in his ears. In his rreview, the physician wrote, "Pt described sensations as dysesthesia. Pt is able to identify this symptoms as dysesthesia." On 1/4/00, total Lyme antibodies by EIA were 2.15. Lyme IgG Western blot analysis was negative; only a 31kDa band was present. Lyme IgM Western blot analysis was negative; only a 31 kDa band was present. On 1/14/00, serologies for hep B and C were negative. Total hep A antibody was reactive. The pt was seen by the reporting physician on 4/13/00 "for increased sensation of burning to tongue and into throat. Pt denies GERD, gas symptoms. Sense of smell is unaffected. No dysphagia with food/fluids. Pt admits to increased pain with numbness/tingling sensation to upper lip area and radiates to roof of mouth, bilateral nares, and chest area. Pt describes as furnace burning." On physical examination, the physician noted, "right facial droop persists/unchanged." The physician's impression was "Dysensation to glossal/pharyngeal/nares area." The pt reported that a rapidly tapering course of Medro Dosepak "had helped in past." Tbe physician prescribed another course. The reporting physician saw the pt on 7/11/00 for a routine physical examination. The pt reported that his only complaint was "chronic 'burning' pain to throat/chest." The physician's impression was "chronic complaint of dyspepsia/retrosternal pyrosis." Elevated concentrations of liber enzymes and creatinine were noted. On 7/21/00, the physician's assessment was "rule out hepatitis." The pt was seen in a pain management clinic on 8/22/00, with a chief complaint of "burning pain in his throat, mouth, and chest." The pt told the pain management physician that "he was in his usual state of health until February of 1999 when he received three Lyme disease vaccine IM injections one month apart. He states that a few days after the first injection, he began to experience burning sensation in his stomach." After the second injection, the burning worsened. After the third injection, the burning progressed to his throat and mouth and nose. He describes his pain as burning, constant, not aggravated and not relieved by any medications or maneuvers. He denies having problems with sense of taste and smell." On physical examination, the physician "could not aggravate his pain by light palpation of his lips and face. I could not reproduce his anterior chest wall pain on percussion and palpation of his sternuma nd costochondral joints. Sensation to pinprick is within normal limits in his face, neck and anterior chest wall." The physician's impression were "chronic neuropathic pain. Rule out burning mouth syndrome." The physician prescribed Neurontin 100mg three times daily. On 8/24/00, folic acid and vitamin B12 concentrations were normal. The pt was seen by the gastroenterologist on 9/26/00 for follow-up regarding the colonic polyps which had been removed on 10/15/99. His medications at that time included Monopril 20mg daily and colchicine 0.6mg daily. The pt reported persistent burning in his chest. The physician's impression was "atypical chest pain." The pt underwent EGD on 10/23/00. The gastroenterologist's impressions were "small gastric ulcer involving the antrum of the stomach. Grade I reflux esophagitis." NO helicobacter-like organisms were seen in the biopsy specimen. The pt also underwent colonoscopy. THe gastroenterologist's impressions were "mild left-sided diverticulosis. No polyps, masses or colitis." THe gastroenterologist stated, "certainly the reflux changes can account for the pt's atypical chest pain. The pt should be on a proton pump inhibitor for a minimum of two motnhs and I have given him a prescription for Prevacid 30mg once a day. Lifestyle modification has been discussed with the individual." He also recommended a high-fiber diet. The pt was seen by the reporting physician on 1/22/01 "for complaint of diffuse arthralgias since November." The pt reported that the burning and dysesthesia persisted. However, "pt relates he feels fine." The physician's assessment was arthralgia and gout. He prescribed indomethacin 50mg twice daily. Serologies for hepatitis had been repeated on 1/16/01. Serologies for hep B and C were negative. Hep A IgM was non-reactive. On 2/27/01, the pt saw the reporting physician "for complaint of increased burning mouth syndrome." On physical examination, the physiican noted "right platysmal muscle deformity and right facial asymmetry." The physician's assessment was burning mouth syndrome and facial asymmetry. On 2/28/01, total Lyme antibodies by EIA were <1.00. The pt underwent computed tomography of the brain, neck and chest, with and without contrast on 3/3/01. The results were "unremarkable." On 3/19/01, the pt was referred to a neurologist. On 4/2/01, rheumatoid factor and antinuclear antibody (ANA) titer were negative. Erythrocyte sedimentation rate was 11mm/hr. The pt was evaluated by a neurologist on 4/16/01. At that time, the pt reported that in addition to the "burning sensations" and dysesthesias previously described, he began having difficulty swallowing food in January 2001 and beginning in February 2001, he began to experience sensations of dryness and the subjective sensation that his eyes were "shrinking" as well as "burning" surrounding his eyes. Additionally, the pt reproted that on 3/25/01, without any warning, he lost all ability to see newsprint on a newspaper, which lasted a few hours before resolving. No abnormalities were noted on physical examination. The neurologist's impressions were "neurological examination today is 'normal' and fails to demonstate evidence of any significant focal or lateralized features. With the clinical history at hand it appears that the pt's complaints of 'sensory' distortion and 'burning' dysesthesias most likely reflect a postvaccinaiton neuropathic problem which is an unusual complication of the Lyme's prophylactic treatment. However, the rapid sequence of injections that he was given and the fact that they continued to be give despite his initial problems probably predisposed him to these persistent symptoms. Though this has not been recommended for patients over 70 I am uncertain as to what role this has actually played in his ongoing saga. The pt's recent problems with 'swallowing' that began in January 2001 remains a confusing issue. However, I suspect that it is probably another manifestation of the 'burning' dysesthesias and 'sensory' perversion that he is experiencing. Nevertheless, I feel that further 'GI' investigation is warranted. THe pt's most recent problem with transient 'visual' distortion which occurred on 3/25/01 remains a confusion issue if by nothing else by the vague and poor description. However, we cannot exclude that this might ahve reflected an unusual type of 'TIA.'" The physician prescribed Neurontin. Additional diagnostic evaluations were unrevealing, except for an abnormal barium swallow. The pt remained under the care of this neurologist until at least 7/16/01. During this time, the physician noted that the pt'sneck had "moderately decreased range of motion in all directions." It was noted by the physician that the pt remained clinically stable from a neurological standpoint. The neurologist suggested consideration of acupuncture. The pt wsa seen by the gastroenterologist on 5/1/01 with a chief complaint of "trouble swallowing." At that time, the pt reported that he had "Lyme disease secondary to vaccination." The physician noted "recent onset of dysphagia over the past two months, mostly with solids but more of difficulty initiating swallow consistent ith oropharyngeal dysfunctional process." His impression was "dysphagia, most consistent with oropharyngeal process quite possibly related to Lyme disease from vaccine." A formal swalowing study was recommended. The results of a modified barium swallow performed on 5/8/01 were interpreted as no abnormality with use of liquid consistency barium but mild retention of solid consistency barium. The pt was evaluated by an ophthalmologist on 4/14/201. At that time, the pt reported, "burning around both eyes. A feeling tha both eyes are swollen. An episode of gray vision in both eyes. He states that ever since he has had Lyme disease immunization injections there has been a burning feeling of the skin around both eyes and both eyes feel somewhat swollen. He also claims that on 3/25/01 he had one episode of gray vision in both eyes that lasted approximately 45 mintues. This occurred while he was indoors. It was moderate to severe. He could not read a newspaper or see anything clearly. After this episode he saw what he calls heat waves in front of his eyes. He states that this seemed to have occurred intermittently for a few days but then it disappeared, and he has not seen any since. His vision subsequently has returned to normal." On examination, visual acuity was 20/40 in the right eye and 20/30 in the left eye with his corrective lenses. "He had a mild amount of blepharochalasia in the inferior eyelids but no erythema. He has prominent muscle insertions on the sclera of each eye. Both corneas were clear; however, he does have a decrease in the tear meniscus with a small amount of mucus in the teat film. He has very early nuclar and cortical cataracts in both eyes. Dialated fundoscopic examination reveals some mild floaters in both eyes. The macular reflex was slightly reduced but the macules were dry with only a minimla amount of dark pigmentation. The nerve fiber layer appeared to be intact in both eyes. The vessels appeared to be of relatively normal size wihtout plaques." The physician's diagnoses were "asthenopia of both eyes of unknown etiology. Possible amaurosis fugax of both eyes. Cataracts of both eyes. Cupping of the optic nerves both eyes. Dry eyes." The physician noted the origin of the asthenopia to be unknown and stated that he had no suggestions on how to treat it. He felt that the possible amaurosis fugax was non-opthalmic in origin and that cardiovascular or neurological etiology "should be entertained." The physician prescribed artifical tears to be used as needed. Transcranial Doppler sonography and bilateral carotid duplex performed on 5/14/01 did not reveal any abnormalities. The pt stated that, following receipt of the third injection of LYMErix, he was told he had "acid reflux," which "was coincidental" to LYMErix administration. The pt alleged that he "developed a severe and permanent burning sensation along his entire oropharyngeal/esophageal tract." He also claimed that he sustained "severe and permanent injuries to his mouth, tongue, throat, esophagus, stomach, and digestive tract." The pt claimed that he is also "suffering from osteoarthritis." The onset of this event, affected joint, and treatment were not provided. Information received on 3/2/01 did not specify treatment of the facial droop or osteoarthritis. The burning sensation along the pt's oropharyngeal/esophageal tract was reportedly worsening. The facial droop and osteoarthritis were ongoing. The most recent info, received on 5/17/02, did not provide the outcomes of the dysphagia, facial droop, osteoarthritis, or Lyme disease. The dysesthesia and burning mouth syndrome persisted as of 7/16/01. The adverse events of dysesthesia, burning mouth syndrome, facial droop, and osteoarthritis do not meet serious criteria but being submitted as an expedited report by special FDA request per the 6/28/00 letter. N 02/11/1999 OTH OTH Monopril, colchicine, temazepam at bedtime, Lopid, multivitamin, vitamin E, vitamin C, vitamin B complex, and garlic. Medical history included difficulty sleeping, bilateral heel suprus, osteoarthritis of the left knee, degenerative changes of the dorsal spine, gout, benign prostatic hypertrophy, hypercholesterolemia, elevated triglycerides, hypertension, glucose intolerance, elevated lactic dehydrogenase, elevated SGOT, elevated creatine kinase, elevated eosinophil counts, and elevated SGPT. The pt had no known allergies and no history of Lyme disease. Surgical history included tonsillectomy and adenoidectomy and repair of a deviated nasal septum. Family history was significant for his father dying at age 38 and his sister dying at age 56; the pt reported the cause of their deaths as "liver." The pt reported that he jogged three miles per day, six days per week. 20010042031 1
0166078 02/22/2001 NJ 41.0 M 02/19/2001 Subsequently the pt experienced whole body arthralgias. A doctor visit was required. The reporter stated that there was no swelling or warmth at the joints. It was unknown if joint fluid was obtained. As of 2/15/01, the outcome of the event is unknown. Y U ANA - neg, RSR - neg OTH OTH Crohns Disease, GERD, carpal tunnel release, chronic low back pain, hypertension 20010042911 1
0166079 02/22/2001 FL 2.0 2 .4 F 02/19/2001 The pt experienced a reddened, swollen injection site. Y 02/13/2001 02/14/2001 1 NONE PVT PUB NONE 1
0166080 02/22/2001 CA 1.0 1 .1 M 01/08/2001 The pt experienced a febrile seizure. Y Y 12/28/2000 12/29/2000 1 PUB PUB NONE NONE NONE CA000164 1
0166081 02/22/2001 LA 0.9 M 02/06/2001 The pt experienced urticaria and a fever of 100.4. Y U CBC, urinalysis PVT OTH Amoxicillin, Elocon Cream conjunctivitis eczema LA010202 1
0166082 02/22/2001 MI 1.0 1 .0 F 02/16/2001 Swelling of entire right thigh with redness and increased warmth. Y Y 02/05/2001 02/06/2001 1 NONE PVT PUB NONE NONE NONE 1
0166083 02/22/2001 TN 0.75 0 .8 M 02/15/2001 The pt experienced a fever of 104, 12 hours post vax that has currently persisted to the 3rd day post vax. Y U 02/12/2001 02/12/2001 0 NONE PVT PVT Amoxil BSOM BSOM 1
0166084 02/22/2001 CA 4.0 3 M 01/22/2001 Approximately 12 hours post vax, the pt developed redness, swelling, warmth at the site of injection. No complaint of pain. The pt experienced erythema that increased to cover entire anterior deltoid area despite "ice packs". On 1/22, 4 days later, warmth and redness persist. No app, decreased activity or mobility. Has appt with MD. U 01/18/2001 01/19/2001 1 PUB PUB NONE NONE NONE CA010008 1
0166085 02/22/2001 CA 2.6 2 .6 F 01/24/2001 The pts mother called reporting that the child woke up vomiting and complained of headache, chills, epigastric discomfort and vomiting. Denies fever or other complaints. U 01/22/2001 01/24/2001 2 NONE PUB PUB NONE NONE NONE CA0166085 1
0166086 02/22/2001 TN 1.3 1 .3 M 02/06/2001 Within 24 hours of receiving the vax, the pt had a fever of 102.8 and a macular, erythematous rash on the trunk, face and neck. Y U 02/05/2001 02/06/2001 1 strep - neg, WBC - 9,000, Polys - 53, HGB - 12.8, Platelets - 157,000 PVT PVT NONE nasal congestion NONE TN01005 1
0166087 02/22/2001 CA 1.08 1 .2 M The pt developed a fever of 103.5 and had a brief seizure lasting 4 minutes. Y Y 02/09/2001 02/09/2001 0 PVT PVT Amoxil, Ventolin slight URI, possible asthma asthma 1
0166088 02/22/2001 KY 7.0 7 M 02/12/2001 Pt's grandmother called and stated pt took one dose of flu vaccine 1/17/01 pt now complains of stomach ache, gas and vomiting. She said that after his 1st dose of flu vaccine before Christmas, he complained numbness of left side and sore throat, he went to Dr for those complaints and was told that he did not feel it was due to flu shot. Diagnosed with positive strept throat. Took antibiotics and recovered without problems. Y 01/17/2001 01/18/2001 1 PUB OTH KY2001012 1
0166089 02/22/2001 CA 28.0 28 M 02/05/2001 Pt states 1 week post vaccination MMR and TD he reported to clinic complaining of temp, vomiting, diarrhea and rash for 3 days. Pt noted moderate rashes with redness on back and chest. Pt stated experiencing muscle and joint pain all over his body. Pt stated last vomiting and diarrhea ends this 4am, Feb 5, checked temp 96.9 once. U 01/22/2001 01/31/2001 9 NONE PUB PUB NONE NONE NONE CA010012 1
0166090 02/22/2001 CA 4.0 4 F 02/05/2001 On 2/5/01 Pt's mother reported complaints of left leg swelling at injection site, on Sat 2/3/01 swelling with redness since Sat 2/3/01. Dr performed pt evaluation. Pt' mother informed to RTC if induration/erythma increased. Pt seen 2/6/01 no treatment. Y 02/02/2001 02/03/2001 1 NONE PUB UNK 1
0166091 02/22/2001 NY 2.5 2 .6 M 02/13/2001 On 11/11/00 pt received Varivox . Pt came in for evaluation on 11/14 of swelling of right arm. (Vaccine given in right upper arm). On PE, patient's entire right arm was swollen and warm to the touch, including upper extremity, forearm and hand. No pain or redness was present. Area did not appear tender. Pt was placed on Keflex for possible cellulitis and Atarax for associated itch. Resolved without further incident. Y Y 11/11/2000 11/14/2000 3 NONE PVT PUB NONE NO NONE 1
0166092 02/22/2001 CA 5.0 2 .6 F Pt received Varicella vaccine 5/19/98. Pt developed mild case of chicken pox 1/17/01. Y 05/19/1998 01/17/2001 974 NONE PVT PUB CA010013 1
0166093 02/22/2001 AL 1.5 1 .5 F 02/12/2001 Report of redness, swelling and hot to touch right thigh, area is about palm size. Child is walking and playing without difficulty. Advised Benadryl Q4 PRN. 02/09/2001 02/10/2001 1 PVT PUB Otitis Media, externa, URI NONE AL0102 1
0166094 02/22/2001 AR 14.0 14 M 01/10/2001 Pt reported localized erythema, warmth, edema and tenderness at injection site. At 10:30pm pt reported edema greater than expected from left shoulder to elbow lasted until 7:00am, shortness of breath 10:30pm until 1:00am. Treated with Tylenol and ice pack. Y 01/09/2001 01/09/2001 0 PUB PUB NONE NONE Sleep apnea, preliminary diagnosed by family MD has not been to the sleep clinic for evaluation yet. Attention Deficit Disorder. AR0901 1
0166095 02/22/2001 NJ 4.0 4 M 02/14/2001 10 minutes after the last vaccination (sequence- DTaP-MMR-IPV). Pt fell and went into a tonic spasm with arching of the back and brief loss of consciousness, no frothing at mouth, no incontinence of urine or stool. Episode lasted about 5 seconds. Pt recovered completely and started talking and walking normally. No past history of seizures. Temp 97.8. Y 02/14/2001 02/14/2001 0 Comp Chem Profile-Pending, scheduled for EEG & CT scan of head. PVT PUB R otitis media, URI NONE 1
0166096 02/22/2001 CA 20.0 20 M 02/13/2001 The pt experienced swelling, pain, warmth to the left deltoid muscle and mild left neck pain, 2 days post vax. Treated with Allegra, Naprosyn, and Ice Y Y 02/10/2001 02/13/2001 3 NONE PVT PVT NONE laceration on left hand NONE 1
0166097 02/22/2001 LA 1.3 1 .4 M 02/12/2001 A telephone report from a friend of the mother; Temperature under arm 102.8F in PM of 2/6/01 X 3 days. A few spots on chest, total 10-15 bumps by 2/12/01. Began on chest and down to legs "looks like mosquito bites". Doctor saw pt and dx'd fever from shots and pus in tonsils with reaction from chicken pox vaccine. On antibiotics and no longer has fever since 2/11/01 PM; is playing. On 2/12/01, called mother and she completed the above information. Y Y 02/05/2001 02/06/2001 1 NONE PUB UNK NONE Ill 2 weeks prior with respiratory sinus infection; premature at 35 weeks (NICU 16 days) (Respirator 10 days). LA010203 1
0166098 02/22/2001 VA 29.0 29 F 02/25/2001 Hives on 1 hand (palm) and both feet hives and burning (evening of #3 HBV). History per pt: Had hives beginning in July but could not remember if before or after 1st Hep-B or 2nd Hep-B; has had "hives" at all intervals since 8/00; resolved 1 week prior to #3 Hep-B. Has been seen by dermatologist but did not relate that she had had 2 HBV's. Was advised to take Benadryl but chose to use Claritin. Y 01/23/2001 01/23/2001 0 PUB PUB NONE NONE NONE Hives~Hep B (Engerix-B)~2~29.00~In Patient VA01008 1
0166099 02/22/2001 MI 6.0 6 F 02/16/2001 5 1/2cm X 4 1/2cm area of redness, induration and bruising and increased warmth. Y U 02/13/2001 02/15/2001 2 NONE PVT PUB NONE NONE Cholesteatoma s/p surgery 1/9/01 1
0166100 02/22/2001 CA 0.2 0 .2 M 02/08/2001 Mother phoned stating baby was fine yesterday. He woke up at 04:00 and is screaming (not crying) until 11:00, napped for 1/2 hour and woke up screaming. Advised MD visit. On Tylenol. Y U 02/07/2001 02/08/2001 1 PUB PUB Phenobarbital NONE Seizures CA010011 1
0166101 02/22/2001 CA 3.0 3 F 01/16/2001 This child broke out with just a few rashes on arms and back. She had a small amount that were disappearing fast. Y 01/16/2001 01/16/2001 0 NONE PUB PUB NONE NONE CA010010 1
0166102 02/22/2001 CA 1.25 1 .3 F 01/16/2001 5 minutes, post vax, the child broke out in something that appeared to be small welt-like and in about 5 minutes, they began to disappear all over. Y 01/16/2001 01/16/2001 0 NONE PUB PUB NONE NONE CA010009 1
0166103 02/22/2001 CA 4.0 4 F 01/29/2001 Redness and swelling on area. Y U 01/16/2001 01/16/2001 0 PVT PUB NONE NONE CA010007 1
0166104 02/22/2001 CA 39.0 39 F 01/29/2001 Rash in joints (knees, elbows, ankles) red, inflammed and itchy. Y 01/22/2001 01/26/2001 4 UNK OTH TB Skin test/Parkdale/45256260/ID Felt a cold coming on Allergy to gluten 1
0166105 02/22/2001 CA 5.0 5 M 01/25/2001 Left arm very swollen, red and hot the day after Hep-A. U 01/24/2001 01/25/2001 1 PVT PUB NONE NONE NONE CA010005 1
0166106 02/22/2001 CA 16.0 16 F 01/24/2001 Pt complained of tenderness noted at left deltoid arm. Noted mild induration at the injection site. No erythema or soft tissue swelling and no heat. Y 01/22/2001 01/22/2001 0 PVT PUB NONE NONE CA010003 1
0166107 02/22/2001 VA 16.0 1 .3 F 02/07/2001 "Pt developed a knot and redness at injection site on right leg (larger than a 50 cent piece) that lasted through 2/4/01". "Pt had seizure and was taken by rescue squad to hospital ER on 2/5/01. Fever was 101F and was dx'd with ear infections at ER". Per mom, she is to see PMD on 2/8/01. Y Y 01/31/2001 02/05/2001 5 NONE PUB PUB NONE NONE NONE Screaming Syndrome~Vaccine not specified (no brand name)~1~0.00~In Patient VA01007 1
0166108 02/22/2001 TN 23.0 23 M 02/06/2001 6cm X 7 1/2cm erythematous and warm to touch area at left shoulder. Given E-Mycin and Hydrocortisone cream and Benadryl. Use ice prn. This event happened 24 hours, later. Treated on 2/1/00 at 12:55. Y 01/29/2001 01/30/2001 1 NONE PUB PUB NONE NONE NONE TN01006 1
0166109 02/22/2001 CA 0.3 0 .4 F 01/25/2001 Parent stated a mild macular rash began on her neck and trunk, 24 hours, post vax, then in 48 hours, child began to cry inconsolably. Follow-up on 1/30/01 by phone, rash lasted 2-3 days; more started behind ears. Y 01/22/2001 01/23/2001 1 NONE OTH PUB Tylenol NONE NONE CA010004 1
0166117 02/22/2001 FL F 06/07/2000 A physician reported that a female inadvertently received an ID injection of TD and subsequently, developed a "large" area of redness at the injection site. She was treated with hot soaks and recovered. Y 01/03/2000 NONE PVT OTH UNK NONE UNK HQ0393310JAN2000 1
0166118 02/22/2001 VA 75.0 75 F 06/07/2000 A 75 year old female reported that, post vax, 2 days later, she developed a 2" red area at the injection site. On 1/16/00, the site became very red, warm, itchy and inflammed; the inflammation extended from the upper arm to below the elbow. The pt was seen by the physician on 1/17/00 and treated with Benadryl, prednisone and applications of ice to the affected area. The pt's previous dose of TD was given in 1967. Y U 01/12/2000 01/14/2000 2 UNK PVT OTH Benadryl, Prednisone UNK UNK HQ0858302FEB2000 1
0166119 02/22/2001 IL 35.0 35 F 02/16/2000 A 35 year old female received TD on 1/11/00. On 1/13/00, she developed an injection site reaction characterized by a 3cm area of redness and warmth. She recovered without treatment. This is 1 of 3 pts from this facility who developed an injection site reaction following receipt of either TD adsorbed or Diphtheria and Tetanus Toxoid Adsorbed. Y 01/11/2000 01/13/2000 2 UNK OTH OTH Tenormin, Imitrex "Glaxo-Wellcome", Nordette-21 UNK Polycystic Ovaries; Hypercholesterolemia; Migraine NOS; Mitral valve prolapse HQ0968208FEB2000 1
0166120 02/22/2001 IL 43.0 43 F 02/16/2000 A nurse reported that a 43 year old female received TD Adsorbed, Ultrafined on 1/24/00. She returned to the physician's office on 1/27/00, after she developed a 3cm to 4cm area of redness and warmth at the injection site. She was treated with hydrocortisone cream. This is 1 of 3 pts from this facility who developed an injection site reaction following receipt of either Tetanus Toxoid Adsorbed or Diphtheria and Tetanus Toxoid Adsorbed. Y U 01/24/2000 01/27/2000 3 UNK OTH OTH Claritin-D UNK Rhinitis allergic NOS HQ0968408FEB2000 1
0166121 02/22/2001 NJ F 12/27/2000 A pharmacist reported that a female may have inadvertently received 1 ml of Tetanus Toxoid Adsorbed, Ultrafined. She developed a "little" pain at the injection site. No further information was available at the date of this report. U UNK OTH OTH UNK UNK UNK HQ1302221SEP2000 1
0166122 02/22/2001 OH F 03/03/2000 A nurse reported that a female pt received an injection of tetanus toxoid absorbed and subsequently developed "swelling". This report was received on 2/29/00, no further information was available at that time. U UNK OTH OTH UNK UNK UNK HQ1354503MAR2000 1
0166123 02/22/2001 IL 59.0 59 U 10/26/2000 A physician reported that a 59 year old pt received an injection of Tetanus Toxoid Adsorbed, Ultrafined on 10/3/00. The next day, the pt developed left parotid gland swelling. U 10/03/2000 10/04/2000 1 UNK PVT OTH NONE UNK HQ1938109OCT2000 1
0166124 02/22/2001 MD F 01/08/2001 A nurse reported that a pt inadvertently received an expired dose of Tetanus Toxoid Adsorbed, Ultrafined or Tetanus Toxoid Fluid on 11/8/00. The vaccine expired in 1998. On 11/8/00, she experienced blurriness which resolved within 2 hours. As of 11/8/00, no further information was available. Y 11/08/2000 11/08/2000 0 UNK OTH OTH UNK UNK UNK HQ3653414NOV2000 1
0166125 02/22/2001 MD F 01/08/2001 A physician reported that a female received an injection of Tetanus Toxoid Adsorbed, Ultrafined on 4/18/00. On 4/24/00, she developed an injection site reaction characterized by right shoulder hives with pruritus. The pt was treated with Benadryl and cool compresses. She recovered. Y 04/18/2000 04/24/2000 6 UNK PVT OTH UNK UNK UNK HQ4610207DEC2000 1
0166126 02/22/2001 CO 40.0 40 F 06/27/2000 A physician reported that a 40 year old female sustained an injury with a foreign body. As part of wound management, the physician administered a SC injection of Tetanus Toxoid Adsorbed, Ultrafined at 10:00 on 5/2/00. Later that day, the pt became concerned that the injury site appeared infected; she went to the ER. The infected injury was treated with cephalexin. A second dose of Tetanus Toxoid Adsorbed (manufacturer unknown) was administered by the ER staff at 15:00 on 5/2/00. On 5/4/00, the pt developed a fever of 100.4F and she also developed redness, inflammation, warmth and pain at each TD administration site. Y U 05/02/2000 05/04/2000 2 UNK PVT PVT NONE Injury with foreign body UNK HQ5532108MAY2000 1
0166127 02/22/2001 MI 26.0 26 F 07/25/2000 A physician reported that a 26 year old female received an injection of Tetanus Toxoid Adsorbed, Ultrafined on 6/20/00. The next day, she developed an injection site reaction characterized by redness, swelling, warmth and induration. This is 1 of 2 pts from this facility who had an adverse experience following receipt of this vaccine, lot 4998103. U 06/20/2000 06/21/2000 1 UNK OTH OTH UNK NONE UNK HQ7831526JUN2000 1
0166128 02/22/2001 MI 25.0 25 F 07/25/2000 A physician reported that a 25 year old female received an injection of Tetanus Toxoid Adsorbed, Ultrafined on 6/17/00. The next day, she developed an injection site reaction characterized by redness, swelling, warmth and induration. This is 1 of 2 pts from this facility who had an adverse experience following receipt of this vaccine, lot 4998103. U 06/17/2000 06/18/2000 1 UNK OTH OTH UNK NONE UNK HQ7842126JUN2000 1
0166129 02/22/2001 FL F 01/24/2001 A nurse reported that an adult female inadvertently received an ID injection of Tetanus Toxoid Adsorbed on 7/14/00. On 7/15/00, she developed redness at the injection site. She recovered within 3 days. The reporter indicated that 2 pts experienced this event; however, only 1 person has been identified. Y 07/14/2000 07/15/2000 1 UNK OTH OTH UNK UNK UNK HQ9178731JUL2000 1
0166130 02/22/2001 F 12/06/2000 A nurse reported that an adult female inadvertently received an ID injection of Tetanus Toxoid Adsorbed, Ultrafined on 7/3/00. Some of the injection may also have been given SC. That day, she developed "slight" induration at the injection site. She then developed redness at the injection site. She reported to the ER but no treatment was given. She applied cold compresses to the site. As of 7/5/00, a "large" red area at the injection site persisted. Y U 07/03/2000 07/03/2000 0 UNK OTH OTH UNK UNK UNK HQ9288601AUG2000 1
0166131 02/22/2001 TX F 12/14/2000 A pharmacist reported that a female received an injection of Tetanus Toxoid Adsorbed, Ultrafined and subsequently developed an area of redness that surrounded her leg wound. She also developed an injection site reaction characterized by swelling and tenderness. The reporter considered these events to represent an allergic reaction to Tetanus Toxoid Adsorbed, Ultrafined. U UNK OTH OTH UNK Leg wound UNK HQ9926116AUG2000 1
0166132 02/22/2001 MD M 07/20/2000 A nurse reported that an adult male received an injection of Tetanus Toxoid Adsorbed, Ultrafined on 12/29/99. The pt subsequently, developed welts with itching on his chest and his hands extending to his elbows. He was treated with prednisone and diphenhydramine. The welts and itching persisted as of 3/13/00. U 12/29/1999 UNK OTH OTH UNK UNK Skin disorder NOS HQ1730722MAR2000 1
0166133 02/22/2001 CO 12.0 12 M 02/15/2001 A nurse reported that a 12 year old male received an injection of Tetanus Toxoid Adsorbed, Ultrafined on 10/23/00 and 8 days later, he developed an injection site reaction characterized by a 3" red, firm, swollen area. According to the reporter, the pt's mother refused to allow her child to be seen by the physician and instead, treated her son with "ginger gel". The reporter indicated that the mother called to report that her son's symptoms gradually resolved. Y 10/23/2000 10/31/2000 8 UNK PVT PVT NONE NONE UNK HQ3619813NOV2000 1
0166134 02/22/2001 FL U 01/10/2001 A pharmacist reported that a pt received Tetanus Toxoid as a child and subsequently developed an allergy. As of 10/12/00, no further information was available. U UNK OTH OTH UNK UNK UNK HQ3873317NOV2000 1
0166135 02/22/2001 NJ 62.0 62 F 01/08/2001 A medical technician reported that a 62 year old female received an injection of Tetanus Toxoid Adsorbed, Ultrafined on 11/13/00. On 11/15/00, the pt developed an injection site reaction characterized by redness and swelling. U 11/13/2000 11/15/2000 2 UNK OTH OTH UNK UNK UNK HQ4152128NOV2000 1
0166136 02/22/2001 IA 34.0 34 F 03/09/2001 A nurse reported that a 34 year old female received an injection of Tetanus Toxoid Adsorbed, Ultrafined on 6/12/00. On 6/14/00, the pt developed a "low-grade" fever and generalized aches. She also developed an injection site reaction characterized by pain and swelling extending to her armpit. The pt recovered. Follow-up info received on 02/26/2001 from the physician indicated that the pt recovered by 06/16/2000 with "no lasting affects." Y 06/12/2000 06/14/2000 2 NONE PVT OTH Ceclor Cellulitis "low grade" HQ4644808DEC2000 1
0166137 02/22/2001 M 07/25/2000 A male who wishes to remain anonymous, reported that he received an injection of Tetanus Toxoid Adsorbed, Ultrafined and subsequently developed an injection site reaction characterized by redness, swelling and induration. U UNK OTH OTH UNK UNK UNK HQ6264522MAY2000 1
0166138 02/22/2001 FL 33.0 33 F 10/03/2000 A 33 year old female reported that she received an injection of Tetanus Toxoid Adsorbed, Ultrafined on 5/26/00. On 6/7/00, she developed hives. She was seen by her physician who prescribed Claritin and Benadryl. Allergy testing was reportedly positive for tetanus. The hives persisted and she was treated with prednisone on 7/5/00. On 8/10/00, the physician prescribed Tagamet and an unspecified antihistamine along with the Claritin previously prescribed. Y U 05/26/2000 06/07/2000 12 Allergen skin test-positive (reportedly positive for tetanus) PUB PUB NONE NONE UNK HQ9804114AUG2000 1
0166112 02/23/2001 NY 32.0 32 F 02/21/2001 On 12/25/00, reported 1st symptoms of sinus congestion and uncontrollable coughing. On 1/3/01, seen in ER with numbness and paralysis. Transferred to another hospital where she was told the dx was Guillain-Barre Syndrome. Is recovering. 60 day follow up states patient is experiencing blurred vision in the right eye. Sinus infection starting 12/21/2000 Y Y 3 N 11/10/2000 01/03/2001 54 PUB OTH augmentin, nicotine patch Mitral vavle prolapse, Depression mitral valve prolapse, depression 1
0166113 02/23/2001 NY 4.0 4 M 02/20/2001 Both eyelids were puffy with red and watery eyes, sneezing but no signs and symptoms of shortness of breath. Treatment with Epinephrine and Benadryl given. Y Y 02/20/2001 02/20/2001 0 PUB OTH Mild eczema NONE 1
0166114 02/23/2001 VA 1.0 0 .8 M 11/10/2000 A routine CBC, done 2 weeks after the Prevnar and HBV were given and showed miniature cells which were referred to a hematologist and prompted an evaluation for leukemia. Y 07/28/2000 08/11/2000 14 CBC PVT PVT NONE Middle ear effusion NONE 1
0166139 02/26/2001 0.25 0 .2 F 02/21/2001 Information has been received from an investigator concerning a 3 month old female who received her 1st injection of Prevnar, Hib-Titer, Infanrix and IPV vaccines and her 2nd injection of Recombivax-HB vaccine on 7/19/00, as part of a study trial. On 8/27/00, the child died due to sudden infant death syndrome. Both the investigator and the medical monitor agree that this event was not related to vaccine administration. Y 08/27/2000 N 07/19/2000 08/27/2000 39 NONE UNK UNK UNK Gastroesophageal reflux disease (The child experienced a life-threatening event due to GERD at 12 days of age. HQ7326116FEB2001 1
0166140 02/26/2001 0.2 0 .2 M 02/20/2001 Information was received from an investigator regarding a 2 month old male who received his vaccinations on 04/25/2000. On 06/14/00, at age of 4 months, the patient died. An autopsy revealed the cause of death to be Sudden Infant Death Syndrome. Both the investigator and medical monitor consider this event not related to vaccine administration. This report of a serious, labeled event is being submitted to the FDA in a 15-day time frame, as requested by FDA. Autopsy also stated the infant had dermatitis, pulmonary edema and congestion. Y 06/14/2000 N 04/25/2000 06/14/2000 50 Autopsy UNK UNK UNK UNK HQ7326316FEB2001 1
0166142 02/26/2001 NJ 34.0 34 F 02/16/2001 Information has been received from a consumer, a 34 year old Caucasian female who in June 1999 and on 7/22/99, respectively, was vaccinated with the 1st and 2nd dose of varicella virus vaccine live and subsequently in August, 1999, the pt found out she was pregnant. Follow-up information from an RN at the physician's office reported that the pt had an elective abortion in October, 1999. It was reported that there was no medical indication for the pregnancy termination but was the personal choice of the pt. No further information is available. Y U 07/22/1999 10/01/1999 71 OTH OTH UNK Herniated disc; Allergy sulfa; Pregnancy WAES99082329 1
0166143 02/26/2001 ND 32.0 32 M 02/15/2001 Information has been received from a 32 year old male and his physician. The patient, noticed that his sister had a Varicella in late December 2000. On 01/12/01 the patient was vaccinated with his first dose of Varicella virus vaccine live, SQ in his left arm. The patient reported there were no vesicles or scabbing noted. On 02/01/01 the patient developed hives on his entire body. On 02/02/01 the patient received Prednisone med pak for 6 days. On 02/04/01 the patient developed edema of the lips, eyes and face, and was seen in the ER. Therapy with intravenous antihistamine was given and the symptoms subsided. Upon internal review it was determined that the hives and edema of the lips, eyes and face were considered to be an Other Important Medical Event. The physician reported that on 02/05/01 or 02/06/01 the patient broke out in chicken pox pustules that disappeared quickly. At the time of this report the rash was better but continued to itch. The physician indicated that the patient did not think he should receive the second dose due to this experience and the physician agreed. Additional follow up from a public health nurse revealed that the patients condition has subsided and the patient was able to return to work. Y N 01/12/2001 02/01/2001 20 OTH OTH UNK UNK WAES01020397 1
0166144 02/26/2001 NY 40.0 40 F 02/16/2001 Information has been received from a health professional concerning a 40 year old female who on 1/25/01 was vaccinated with MMR II. On 1/27/01, the pt thought the injection site felt unusual. On 2/4/01, the pt was seen and treated in the ER for a huge boil or abscess that was swollen, red, hot and painful. Upon internal review the furuncle was determined to be an "Other Important Medical Event". The area was lanced and packing placed in the area. Therapy with Ceftin and Tylenol #3 were initiated. On 2/5/01, the pt had a packing changed in the ER. On 2/6/01, the pt saw a surgeon. The nurse reported in follow-up that the site was healing slowly and she is still recovering. Additional information has been requested.F/U additional info from the nurse indicated that the pt's recovery was ongoing ans she was healing. The abscess was considered an other medical event. No further info is available. Y N 01/25/2001 01/27/2001 2 UNK UNK UNK NONE WAES01020630 1
0166146 02/26/2001 LA 52.0 52 M 02/13/2001 On 2/2/01, approx. 18:00, feet started to itch, then broke out in "hives" on trunk and right hand started to swell then had hoarseness and "sore" throat. Went to ER at 19:00 and was there until 23:59 and went home. Put on Zantac and Benadryl. Was given IV and shot of Benadryl at 2nd time in ER. (Was at hunting camp, Friday, when reaction occurred. Returned home at midnight after being seen in ER. On 2/3/01, Saturday AM, symptoms of itching, hives and pain and swelling in both hands had returned. He then went to local ER and was seen by ER MD and wife states he was given IV and injection and sent home. Told at both visits to the ER's that it was an allergic reaction to the flu vaccine, as this was all that was different or unusual in his routine. He has had previous flu shots in the past years. He was improved after treatments and pain and swelling started to resolve. No breathing problems. No problems Saturday or Sunday. On Monday, 2/5/01, at approx. 07:00, had started to complain of pain and swelling in right hand and left hand and feet starting to itch again. Experienced "sore throat" and hoarseness again. He went to his local MD and was admitted to the hospital and given Benadryl, Zantac IV and other things "pain meds") He was hospitalized from 2/5/01 until 2/8/01. Discharged on 2/9/01 and told by MD that he had Rheumatoid Arthritis and given Vioxx for pain and given "Z-pack" for inflammation. Wife comes to health unit today, 2/13/01, to inform me of pt's adverse reactions to flu vaccine. He is still having problems. Right hand swollen and pain in right arm. Also, feet have started to itch again as of yesterday. He is not convinced that he has Rheumatoid Arthritis and feels that his symptoms are still related to adverse vaccine reaction. Went to see another doctor for a second opinion and further treatment as he is very uncomfortable. It was suggested that he go to another hospital that has an arthritis clinic. Per annual follow up: Patient has had no more complications from the influenza vaccine from last year. He has not taken any more influenza vaccine as per doctor's order. Y Y 4 Y 02/01/2001 02/02/2001 1 PUB PUB Insulin X 2 per day, Glucophage, Altace, Lipitor, ASA NONE diabetes, heart disease LA010204 1
0166147 02/26/2001 OH 29.0 29 M 02/15/2001 Swelling at injection site, raised, reddened area measuring 70mm X 70mm at injection site of left deltoid. Pt experienced some malaise and fatigue. Seen by our MD. Treated with ibuprofen prn. Y 01/30/2001 02/01/2001 2 NONE PVT MIL Migraines 1
0166148 02/26/2001 CO 0.9 1 .0 M 02/14/2001 Red, hard bump/infection. Treated with Biaxin. Y 02/10/2001 02/12/2001 2 PVT PVT NONE NONE NONE 1
0166149 02/26/2001 CO 0.4 0 .4 F 02/13/2001 Left thigh red, hard bump the size of a quarter. Y 02/09/2001 02/09/2001 0 NONE PVT PVT NONE NONE LOM and URI on 12/27/00 treated with Amoxicillin 1
0166150 02/26/2001 CO 1.25 1 .3 F 02/13/2001 Hard lump on right thigh/ red/size of a quarter. Y 02/09/2001 02/09/2001 0 PVT PVT NONE NONE BOM/Bronchiolitis on 1/22/01 treated with Amoxicillin. 1
0166151 02/26/2001 NM 1.0 1 .0 F 01/30/2001 Rash and fever for 3 days prior to ER visit. Seen in ER X 1 then by Pediatrician the next day. Treated with acetaminophen for fever control. Pediatrician felt MMR II was the culprit. Y Y 01/19/2001 01/27/2001 8 PUB PUB Peds Panacea Viral acute GE NONE 1
0166152 02/26/2001 NM 1.0 1 .0 M 02/08/2001 MMR administered to pt with measles signs and symptoms appearing 3 days later. Child's mother noticed a rash on the upper body and neck of child and brought the child to the medical center for check-up by pediatrician. Y Y 02/05/2001 02/08/2001 3 PUB PUB Tylenol NONE NONE 1
0166153 02/26/2001 SC 69.0 68 F 02/01/2001 Pt came to clinic complaining of rash with itching on 1/26/01. States rash developed on 1/24/01. Rash observed by nurse on back, waist and under arm. Pt states she may have run fever. Pt instructed to take OTC Benadryl for itching. Pt called back on 1/29/01. She went to ER on 1/27/01 and was given cortisone injection and sent home on oral pk cortisone. Pt was instructed by ER to found out if she was allergic to component in Flu shot. Y U 01/22/2001 01/25/2001 3 PUB UNK SC0105 1
0166154 02/26/2001 AR 44.0 44 M 01/16/2001 On 1/16/01, pt in for complain of soreness at injection site on left deltoid and across back, previously between shoulder blades since flu vaccine received on 11/7/00. States pain had been across chest also but that pain has since been relieved. States he saw MD on 12/15/00 for complaints and was treated with anti-inflammatory RX. Pt was advised to return to PMD ASAP. Pt was treated with Voltaren po and Flexeril po; dx was thoracic paraspinous spasm; pt was not recommended for additional follow-up after 12/20/00 appt. Y U 11/07/2000 PUB PUB Zyrtec and Flexeril po prn History of Hep-B and Hep-C AR1001 1
0166155 02/26/2001 NH 1.0 1 .2 M 02/21/2001 On 1/11/01, had well child visit. On 1/16/01, to ER with temperature of 103F with febrile convulsion. Dx'd with viral infection. On 1/17/01 follow-up, fever was down to 99.9F. Throat infected. Mom has history of febrile seizures as a child. Y Y 01/11/2001 01/16/2001 5 CBC with Differential-viral infection; CXR; UA PUB PUB NONE NONE NONE NH0105 1
0166156 02/26/2001 OH 0.75 0 .8 M 02/22/2001 Hives less than 24 hours, post vax. Y 02/20/2001 02/20/2001 0 PVT PVT NONE NONE NONE 1
0166157 02/26/2001 NH 1.0 1 .0 F 02/15/2001 Rash on side after vaccine. erythema, macula papule. U 01/31/2001 02/13/2001 13 NONE PVT PUB NONE NONE NH0104 1
0166158 02/26/2001 AK 47.0 46 U Pt has 1 1/2" diameter hard and painful swelling at injection site. U 02/13/2001 02/14/2001 1 PVT PVT NONE NONE Blind 1
0166159 02/26/2001 WI 1.5 1 .5 M 02/14/2001 Approx 48 hours post DPT injection, swelling, induration and erythema at site in right thigh. Max. diameter 11x11cm.Reaction lasted 7 days locally with gradual decrease in size of indurated area to 1cm diameter. Y 01/12/2001 01/14/2001 2 PVT PVT NONE NONE NONE 1
0166160 02/26/2001 OR 32.0 32 F 02/02/2001 Pt reports rash, hive like spots appeared on chest day after receiving #2 Hep B. Spots itch. Friday morning (2 days after, increased spots, stomachache , malaise, insomnia. U 01/31/2001 02/01/2001 1 OTH PVT NONE NONE Allergic to cats, fresh fruit/vegetables, scolosis (L) leg shorter 3/4". OR200102 1
0166161 02/26/2001 SC 69.0 69 F 02/15/2001 Pt reports no immediate problems, shortly after receiving injection, however on following morning she woke up with intense itching and red macular rash on arms, abdomen, back and legs. She went to PMD and Dr thinks it was allergic reaction to Hepatitis vaccine and he gave her a shot of cortisone and a prescription for Prednisone 60mg daily x 7days. Pt also reports that greater than one week ago she had poison sumac which was treated with topical ointment. Y Y 02/02/2001 02/03/2001 1 PUB UNK NONE Codeine SC0103 1
0166162 02/26/2001 OR 4.0 4 M 01/29/2001 7 days post vax, the pt developed a fever, cheeks were flushed and then became cold and clammy. Behavior was more difficult to control from 7-14 days post vax. 10 days post vax, noticed 1 inch diameter red, hard, knot at the injection site. Small red spot on chest at 2 weeks. U 01/15/2001 01/22/2001 7 NONE PUB UNK NONE autism, allergy to milk OR200101 1
0166163 02/26/2001 SC 10.0 10 F 01/30/2001 Pt started to develop itching within 5 min of injections. Small welts developed on LT arm. Large welts developed on Rt arm. one welt developed on side of neck. Vital signs taken at 9:30, BP 102/88, pulse 62, resp 24. Benadryl 25mg given IM RA deltoid. Vital signs re-checked 5-10 min times 30 min. Dr notified. Follow-up Q 4-6 hrs at home if welts re-occur, ER if breathing difficulty. Pt to be at home with Mom. Left at 10:00am BP 100/60, pulse 114. Y 01/30/2001 01/30/2001 0 PUB UNK NONE NONE SC0104 1
0166165 02/26/2001 AR 10.0 10 F 01/29/2001 Pt received MMR and Hepatitis B on 1/26/01. By evening pt reported fever (?amt), muscle aching - 1/27/01, continues with aches. 1/28/01 whelps reported by mother to face and neck - Treated in ER with Benadryl and antibiotics. Improvement 1/28 now returning. Y U 01/26/2001 01/28/2001 2 PUB PUB Tylenol PRN NONE NONE ~DTP (no brand name)~1~0.25~In Sibling AR1101 1
0166166 02/26/2001 VA 5.0 5 M 02/19/2001 Pt reports excoriated, papular lesions on face, trunk and extremities. U 01/29/2001 02/18/2001 20 PVT PVT NONE NONE NONE 1
0166168 02/27/2001 CA 63.0 M 02/01/2001 No data listed. Y Y 10/23/2000 10/23/2000 0 PVT PVT Sulfmyproyz NONE Sulfhydroxl Unspecified reaction~Pneumo (no brand name)~1~51.00~In Patient 1
0166169 02/27/2001 IL 0.2 0 .2 M 11/15/2000 This patient died 11/14/00, from possible SIDS. He was taken to the ER 11/14/00, after being found in his crib cyanotic at 8:30 AM. Autopsy also states pulmonary congestion and edema. Final opinion of autopsy is the infant died because of sudden infant death syndrome. Y 11/14/2000 N 11/13/2000 NONE PVT PVT NONE NONE NONE 1
0166170 02/27/2001 1.25 0 .8 M 02/22/2001 Information has been received from an investigator concerning a 15 month old male who received his first injection of Prevnar, his second injection of Recombivax-HB, and his third injection of Hib-Titer and Infanrix vaccines on 08/07/00. The child was found in his crib one morning not breathing and in cardiac arrest. The child was taken to a local emergency room where a heartbeat was re-established following a long code. The child was placed on a ventilator, but was unresponsive to light and painful stimuli. The patient was removed from the ventilator and died due to "SIDS-LIKE SYNDROME" on 01/11/01. Both the investigator and the medical monitor agree that this event was not related to vaccine administration. NOTE: This report is being submitted in a 15-day time frame as requested by FDA. F/U received on 4/25/02 from the study investigator contained autopsy results. The reported cause of death has been changed from "Sids-like syndrome" to "cardiorespiratory failure (cardio-respiratory arrest) secondary to possible sepsis, etiology unknown" as found upon autopsy. The investigator considered the event not related to vaccine administration. Y 01/11/2001 Y N 08/07/2000 01/09/2001 155 NONE UNK UNK UNK 2/20-bronchiolitis and given Albuterol; 1/4/01-croup; 1/7/01-inner ear infection and given Vantin HQ7324416FEB2001 1
0166171 02/27/2001 GA 1.2 0 .2 F 02/12/2001 The doctor came in to check my daughter and said she was perfect, 10 minutes before the shots. Then 10 minutes after she received the shots she was dead. The doctor does not tell you to wait so I had already started home. I had to stop the car and ask for help. Thank God there was a lady that Stopped to help and she did CPR on my daughter. The ambulance came and she was taken to the ER. The doctor in the ER said she was sorry, but my daughters doctor, had refused to come to the hospital and see her. She was admitted to pediatrics and the doctors on call there had to take care of her. The doctors ran several tests on her, they checked her heart with EKG, Heart ultrasounds, checked her blood, gave her an IV and all the test came back perfect. Nothing was wrong with her blood or her heart or lungs so it had to be the shots. Later on that night of 01/30/01, the family pediatrician came to the nurses station. My daughter was right across from the nurses station, he stayed for over an hour and still never came in my daughters room. When he started to leave my mother stopped him and asked what had happened to My baby, he stated he did not know but it could not have been the shots. My mother told him, he said 10 minutes before the shots she was perfect( she weighed 14 1/2 lbs, 25 1/2 '' long). Then 10 minutes after the shots she was dead. She also asked him why don't you tell people to wait but, he stated nothing has ever happened and we see no reason to tell people to wait. He still never came into to check on her. The doctors on call said they would check her to see which shot she was allergic to but they came in the next day and dismissed her without a care in the world. For a few days after the shots she would scream and cry for 10-20 minutes non stop. This child never did this before, she only cried when she was hungry or wet. Some days she sits like she is in a daze. She goes to sleep and it is really hard to wake her up and if she does wake up, she only opens her eyes a little and back to sleep she goes. It hurts to know that she had never been sick before this, she was perfect in my eyes and in the doctors eyes. As soon as the shots were given they said you can go just give her Tylenol for fever. They never said nothing bad could happen and they never gave me any papers on the shots until she had already taken the shots. By the time we walked out the doctors office and got to the car she was still crying, but as soon as I put her in the car seat and buckled it she dropped off just like she was sleeping, taking deep breaths. I just thought that the shots made her sleepy. So we proceeded to leave the parking area we had already gotten to a red light when I realized she would not respond to my voice. I then took her out of the car seat and this time she was not breathing. There was to much traffic to turn around so my mother got out of the car asking for help. She was unresponsive and her eyes rolled in the back of her head. She had no pulse, or heart beat. That's when a lady approached the car and told my mother she knew CPR. I gave her my daughter and by the time I got out of the back passenger seat and got to the drivers side, My baby was breathing. She had to do only two chest compressions and she was breathing again. I wrote this letter FEB.12, 2001, and for the past couple of days my daughter seem to be fine. I appreciate the time you are taking to read my letter. Thank you. Discharge diagnosis: apneic episode A follow up report received 4/20/2001 adds (from mother) Her breathing is fine, she is great, as perfect as before the shots were given. She has never ran a fever or been sick except for the tragedy from the shots. Thank you for your help. Y Y 1 Y 01/30/2001 01/30/2001 0 All kinds of tests; EKG's; Ultrasounds of heart; Blood tests-all tests wnl PVT UNK NONE NONE NONE 1
0166173 02/27/2001 MS 4.0 4 M 02/22/2001 On 02/14/01, the mother noticed the patient was really sluggish with fever. On 02/15/01, the patient began bruising by just touching things. On 02/16/01, the patient saw the MD. the patient was admitted to the hospital diagnosed with severe ITP crisis. The patient had severe petechiae all over his body. The patient was given 2 rounds of gamaglobin. Discharged on 02/19/01, from the hospital. The MD said he was unsure if S/P vaccines or maybe vaccine overload. He will be followed up in 1 year. The 60 day follow-up states the mother says that the child still has bruising and feeling sluggish. Lab was done 1 week ago (platelet count 70,000). Has appointment in Aug. with pediatric oncologist. If platlet count is still low will do bone marrow aspiration. The follow up received on 6/2/01 states "our first OV with pt was 2/16/0. Pt has not been given any vaccinations in this office." Y 4 Y 02/09/2001 02/14/2001 5 Platelet count on 2/16/01-2; platelet count on 2/19/01-138. follow up information 04/24/2002 states "Pt is currently in self remission. she said " last platelet count 290,000". PUB PUB NONE NONE NONE Severe petechiae~DTaP + Hib (no brand name)~4~1.00~In Patient MS01007 1
0166174 02/27/2001 IL 6.0 1 .1 M 01/29/2001 After watching some past videos, I believe my child had a reaction to the MMR vaccine he was given on 12/11/95. By the following December of 1996, we were having his hearing tested, due to an obvious language delay. Within months, we learned he had autism. He was officially dx'd as autistic in 10/98. There was a noticeable difference in behavior by 12/25/95 and we make reference on tape of how sick he had been earlier thus making me believe now, that he had a reaction. 60 day follow-up states the pt still has autism and he has been tested for heavy metals and the level of mercury is 8. Y N 12/11/1995 12/25/1995 14 PVT PVT (L) OM and RAD per pediatrician's office note. RAD 1
0166177 02/27/2001 VA 30.0 F 02/23/2001 Information has been received from a physician concerning an adult female who was vaccinated on 11/15/90. In January 2001, the patient experienced pneumococcal sepsis. The patient was admitted to the hospital on approximately 01/19/01. She was diagnosed with pneumococcal sepsis of 9N followed by pneumothorax. The patient was placed on a ventilator for one week. She experienced kidney shut down. She experienced no urinary output for 36 hours. Blood pressure was 30/0. There was a secondary diagnosis of lupus. The patient was receiving large doses of Prednisone. The patient was very weak. An anticipated date of discharge was unknown. The patient's symptoms persisted at the time of the report, and she remained hospitalized. It was reported she would require extensive rehabilitation. No further information is available. Follow-up from a physician concerning an adult female "in her 30's" who in 11/99 was vaccinated with pneumococcal vaccine 23 polyvalent (lot 629633/1993H). The pt had received pneumococcal vaccine 23 polyvalent (Pnu-Imune, lot 285908) on 11/15/90. On approx. 1/17/01, the pt was seen as an outpt for wheezing and asthma and was treated with pulse steroids. On approx. 1/19/01, she was admitted to the hospital with bacterial sepsis. She was very hypotensive in the ER with a systolic blood pressure in the 30's. She was treated with dobutamine and dopamine. The pt's symptoms persisted at the time of the report and she remained hospitalized. It was reported she would require extensive rehabilitation. Follow-up was received which indicated she was extubated and discharged to a nursing rehabilitation facility on approx. 2/13/01. The pt was improving very slowly with no use of her legs at this point and only functional use of her upper extremities. The bacterial sepsis was found to be secondary to S. pneumoniae type 9N. No further information is available. Y Y N 11/15/1990 01/01/2001 3700 CT head-Bilateral basal ganglia infarct UNK UNK Prednisone Deep venous thrombosis; nephritis; pericardiotomy; pericarditis; seizure; systemic lupus erythematosus WAES01020810 1
0166182 02/27/2001 NM 3.0 3 M 01/11/2001 Temperature of 102F since injection on 1/9/01 and leg pain. Small amount of induration on left upper thigh but no erythema. Walks with limp. Had hives in office on 1/11/01. Y U 01/09/2001 01/09/2001 0 NONE PVT UNK NONE NONE NM010001 1
0166183 02/27/2001 CO 1.3 1 .4 M 02/07/2001 One day, post vax, fever started, swollen glands. Peak fever of 105F on 1/26/01 but glands better. Vomiting and diarrhea for 3 days. On 1/26/01, testicles/leg/thigh were bright red and swollen from knee to groin and tender. Redness traveled up to chest. Advised to be seen at local clinic. Started on Duricef because of questionable infection from injection site on right leg. Had temperature 103F and was given ibuprofen. On 1/29/01, still fussy with increased sleeping but doing better. Occasional runny stool, tolerating liquids and leg is better; no red streaking. Scrotum still slightly streaked but swelling down. On 2/1/01, 9 days, post vax, rash started with red splotches on legs and back; fever to 101-102F, lasting intermittently, for 3 days. Y Y 01/23/2001 01/24/2001 1 CBC-looked like bacterial infection PVT PUB NONE Slight cough, recovering from viral URI NONE 1
0166184 02/27/2001 FL 3.0 3 F 02/18/2001 Child had fever of 103F, the same day. Was evaluated in office on 2/16/01 and had leukocytosis on that day. Her WBC were 27,000. A blood culture, urine culture/analysis and CRP were done. She received Rocephin IM on 2/16/01 and 2/17/01. On 2/19/01 her WBC were 8.9. Y Y 02/15/2001 02/15/2001 0 Blood culture and urine culture-pending; WBC, CRP-8.18; UA-nml; Granulocytes-76% PVT PUB NONE; 3yr. well child checkup NONE 1
0166185 02/27/2001 MI 2.0 1 .2 M 02/12/2001 ER visit on 1/30/01 at 19:00. Temperature was 105.9F (R). Doctor state may be from viral infection. He did have Advil on 1/29/01 and 1/30/01 for low-grade fever. Had temperature increase until 2/2/01 with no other symptoms. Y Y 01/29/2001 01/30/2001 1 PUB UNK NONE Allergies to peanuts, tomatoes, eggs. MI2001016 1
0166186 02/27/2001 MS 81.0 81 F 02/15/2001 Pt reports having a headache X 2 days, then nausea and vomiting X 1 day. Pt reports she was afebrile. Pt also reports an outbreak of fever blisters. Pt feel weak now. Pt encouraged to see MD for continued weakness. Y 02/06/2001 02/06/2001 0 PUB UNK Type II Diabetes MS01006 1
0166188 02/27/2001 KS 33.0 33 F 02/20/2001 Approx. 2 days, post vax, the pt reached down to pick up child and felt a popping sensation. Resulted in pericarditis possibly. Fluid between lung and chest wall (left). Signs and symptoms continued: Hurts when you supine. Placed on steroids and Vioxx. Pain through my rib cage on left side. Amoxicillin on 2/20/01. Y U 11/21/2000 11/23/2000 2 Echocardiogram; CAT Scan of chest; Chest X-ray; CBC; Lupus test OTH PVT Desogen NONE Allergy to Biaxin 1
0166189 02/27/2001 OH 71.0 71 F 02/09/2001 The pt reports that within 24 hours the left arm was swollen, hot and red from the elbow to the shoulder, "one huge hive" and extreme itching. The family MD was not available and the Pt went to the ER. Treated with Prednisone and Atarax for itching. Y Y 01/30/2001 01/31/2001 1 PUB OTH UNK NONE allergy to eggs arm was swollen, hot red with extreme itching and a huge hive~Influenza (Seasonal) (no brand name)~~60.00~In Patient OH0003 1
0166190 02/27/2001 MN 4.0 1 .9 M 02/12/2001 The pt was diagnosed with Varicella on 4/25/00, sore throat, headache, fever, blisters (2) on trunk, (1) on arm exposed to chicken pox 10 days prior. (Clusters of blisters) more than 20. Y 12/03/1998 04/24/2000 508 varicella titer - less than 1:10 PUB PUB NONE NONE NONE WAES01020960 1
0166191 02/27/2001 MN 31.0 31 F 02/21/2001 24 hours post vax, the pt developed hives on her neck, stomach, and thighs. Treated with Benadryl. Y N 02/19/2001 02/20/2001 1 OTH PVT NONE NONE allergy to detergent 1
0166192 02/27/2001 MI 1.5 1 .6 F 02/08/2001 On 2/6/01 the pt's right thigh developed swelling and redness, an area of bruising and some itching. No apparent discomfort, bruising, rash or reddened area is raised right thigh swelling. Mom states also hx of eczema. Advised to try cool compresses to right thigh. Also advised to consult with physician. Y 02/05/2001 02/06/2001 1 PUB PVT NONE NONE NONE MI2001015 1
0166193 02/27/2001 OH 5.0 5 F 02/07/2001 One day post vax the pt's left upper arm was red, hard, with quarter-sized lump and warm to the touch. Swelling, warmth and the hardness progressed. On 2/5/01 the left upper arm redness and swelling was the size of 3 silver dollars, still warm, hard. No fever was noted. On 2/7/01, mom noticed the child's hair was falling out in clumps. Y U 01/24/2001 02/07/2001 14 PUB PUB OH0001 1
0166194 02/27/2001 OH 41.0 41 M 02/09/2001 The pt experienced itching skin on 2/2/01 and that evening started to break out in hives. States took 2 doses of Benadryl with some relief. States by 2/3/02 morning the whole body was covered with hives and went to the ER. Was given 2 steroid shots and sent home with 3 day supply of steroid medicine. Called on 2/6/01 and the pt states welts are still there, joints are sore, tired with some nausea. Advised to call family MD or go to ER. MD's office prescribed steroid medication. On 2/9/01 pt is better. Y Y 01/23/2001 02/02/2001 10 PUB PVT NONE NONE NONE OH0002 1
0166195 02/27/2001 OH 0.5 0 .5 F 02/13/2001 The pt experienced a high fever for 3 days ranging from 103-105. The pt also experienced a poor appetite, irritability, crying, spells for 4 days. "Would turn blue especially around the mouth and extremities shock. Y Y 05/16/2000 05/16/2000 0 NONE PUB PUB NONE OH0004 1
0166196 02/27/2001 OH 1.3 1 .4 F 02/09/2001 The pt experienced swollen eyes, rash with welts from waist up. The feet were swollen redness to the left leg. ER administered Benadryl and Motrin. Y Y 02/07/2001 02/08/2001 1 PUB PUB NONE NONE NONE OH0005 1
0166197 02/27/2001 TX 1.8 1 .8 U The pt experienced a swollen, red left thigh with cellulitis. Y Y 02/14/2001 02/15/2001 1 PVT PVT 1
0166198 02/27/2001 MO 0.3 0 .4 M 02/20/2001 The pt experienced 12 hours post vax. the pt developed a fever of 103.2. No other symptoms. The fever resolved later that day and then experienced a diffuse erythematous tiny papular lesions appeared all over the body. Y Y 12/06/2000 12/06/2000 0 CBC PUB UNK viral infection NONE 1
0166199 02/27/2001 NJ 5.0 1 .1 F 02/21/2001 On 2/19/01 the pt woke with one lesion. As the day progressed, more bumps appeared. The pt had 20 vesicles on trunk and non-focal lesions on body. Advised to treat with Benadryl as needed. Y Y 12/04/1996 02/19/2001 1538 NONE PVT PVT NONE NONE NONE 1
0166200 02/27/2001 NM 29.0 29 F 01/31/2001 The pts husband called and stated theat his wife began complaining of swollen painful glands on back of neck and behind ears. The pt saw her MD, he was unsure why the pt was having symptoms. Y Y 01/18/2001 01/25/2001 7 PUB UNK NONE NONE NM010005 1
0166201 02/27/2001 NM 1.08 1 .1 F 02/01/2001 The pt experienced a light rash on stomach and back of neck and a few on the face. The pt also experienced a slight fever. N 01/19/2001 01/29/2001 10 PUB PUB Tylenol NONE allergy to Amoxicillin NM010006 1
0166202 02/27/2001 NM 12.0 12 M 01/30/2001 The pt experienced a rash on hands and feet following vax. Was told by physician it was hoof and mouth disease. The pt developed a rash on arms, chest, back and legs. The child was seen by the MD and is currently on steroids. Y Y 01/24/2001 01/25/2001 1 OTH OTH NONE NONE NONE NM010004 1
0166203 02/27/2001 TX 2.0 0 1 F 02/14/2001 The pt was diagnosed with chicken pox on 2/12/01. Lesions noted on abdomen and chest, approximately 15 lesions. U 12/01/1999 PVT UNK 1
0166204 02/27/2001 FL 65.0 65 F 02/21/2001 The pt can't put hands to mouth and swelling at the site. The pt's neck and back hurts, no complaints prior to last night. U 02/15/2001 02/20/2001 5 PVT OTH abrasion to right leg 1
0166205 02/27/2001 MD 5.0 1 .0 F 02/23/2001 The pt experienced several maculo-papulo lesions on face, behind ears, trunk and arms few with vesicles, one with scab on leftl mandible. Treated with Benadryl and calamine lotion. Y 11/28/1995 04/11/2000 1596 PVT PVT NONE ~Varicella (Varivax)~1~8.00~In Sibling 1
0166206 02/27/2001 MD 8.0 3 M 02/23/2001 The pt experienced a few pox on abdomen, back and behind right ears. Treated with Benadryl for 24 hours. Y 11/28/1995 03/27/2000 1581 PVT PVT NONE 1
0166207 02/27/2001 MD 13.0 8 M 02/22/2001 The pt experienced several papules, pruritic. The next day, more appeared on the scalp, ears, trunk, proximal arms, genitalia. The pt also had a case of chicken pox at 15 months of age. Y 05/25/1995 01/25/2001 2072 PVT PVT NONE 1
0166208 02/27/2001 MD 4.0 1 .0 F 02/23/2001 The pt developed Varicella. Y 09/29/1997 01/29/2001 1218 PVT PVT NONE 1
0166209 02/27/2001 MD 11.0 5 M 02/23/2001 The pt experienced a full blown case of Varicella. Y 05/25/1995 02/18/2001 2096 PVT PVT NONE 1
0166210 02/27/2001 MD 10.0 4 F 02/21/2001 The pt experienced small scattered papules all over the body. 1 small papule in mouth and 3 early scabs on trunk. Treated with Benadryl. Y 08/22/1995 02/09/2001 1998 PVT PVT NONE 1
0166211 02/28/2001 WA 0.3 0 .3 F 02/01/2001 Pt died of SIDS on 1/29/01, in the afternoon. She had no preceding symptoms was breast fed about 1 1/2 hour before the event where she was found dead in a crib. Pathologist's autopsy findings consistent with SIDS. Y 01/29/2001 N 01/25/2001 01/29/2001 4 Autopsy - SIDS PVT PVT NONE NONE 1
0166212 02/28/2001 FL 58.0 58 M 02/21/2001 Pt was given Hep-A vaccine at 18:00-18:15. He was a chaplain with the Police Dept and was riding with a Police Officer. The Police Officer took the pt home at 23:30. States that the pt had no complaints at that time. At 02:15, the Police Dept was informed by the pt's wife that he had been sent to the hospital and died. Autopsy states cause of death as atherosclerotic cardiovascular disease. Other significant conditions: diabetes, hypertension, obesity. Y 02/21/2001 N 02/20/2001 02/21/2001 1 UNK PUB OTH UNK NONE CHF; CHD; IDDM 1
0166213 02/28/2001 NM 0.5 0 .5 M 02/16/2001 No data received. Autopsy states cause of death as probale asphyxia. Y 02/15/2001 N 02/09/2001 PVT PUB Resolved bronchiolitis; 35 week preemie 1
0166214 02/28/2001 WA 0.2 0 .2 F 02/14/2001 Parents found infant in crib upon arising; infant had expired. Y 02/09/2001 N 02/07/2001 02/09/2001 2 NONE PVT PUB NONE NONE Bronchiolitis January, 2001 1
0166215 02/28/2001 MD 0.5 M 02/08/2001 Pt received vaccines on 2/5/01 in the PM. Did experience fussiness and low-grade fever. Was treated with Tylenol. In the AM of 2/6/01, was found unresponsive. Y 02/06/2001 Y N 02/05/2001 02/06/2001 1 Autopsy-pending PVT PVT Tylenol prn NONE Prematurity (35 weeks); Twin gestation 1
0166217 02/28/2001 NY 0.3 0 .3 F 02/23/2001 A physician reported that a 4 month old female pt received IPOL, Acel-Imune, Hib-Titer and Prevnar vaccines on 2/16/01. Reportedly, the pt had a seizure, 24 hours, post vax, and had 4 more seizures over 2.5 days. The pt was hospitalized. From follow-up information received on 3/7/01, it was reported that the pt was hospitalized for 4 days. Additional pt, vaccine, vaccine administrator and responsible physician information was also provided. Y 4 U 02/16/2001 02/17/2001 1 Spinal Tap; EEG; MRI; Blood and CSF cultures; UA; Blood Chemistries; Urine for amino acids and organic acids UNK UNK GERD U2001004320 1
0166221 02/28/2001 DE 0.25 0 .3 M 02/26/2001 The evening of the vax, the pt developed a fever, perioral cyanosis and respiratory arrest. He was hospitalized. An electrocardiogram, electroencephalogram, ultrasound, thoracic x-ray and echocardiogram resulted in "no pathological findings". The reporter considered the events to be life threatening. The infant recovered. Y Y 02/08/2001 02/08/2001 0 EEG; EKG; Ultrasound Doppler; X-ray NOS; ECG-all wnl OTH OTH UNK UNK UNK HQ7594323FEB2001 1
0166224 02/28/2001 OH 0.5 0 .6 M 02/07/2001 The pt experienced 2 seizures, total of 2 at 15 minutes apart. The 1st seizure lasted 20-30 seconds and 2nd seizure lasted 5-10 seconds. Y 2 Y 01/25/2001 01/28/2001 3 CT and MRI of brain - nml, EEG - slowing PVT PVT Xopenex, Pulmicort Treated with aerosols for croup X 3 days prior 1
0166225 02/28/2001 IL 21.0 21 M 02/06/2001 One hour post vax, the pt became dizzy, confused, decrease in comprehension, complained of headache and neck burning, dry mouth, "Hot", had URI. The pt had fatigue and ache 1 week prior to vax. Diagnosed with disassociative reaction of unclear origin Y Y 1 Y 01/31/2001 01/31/2001 0 CBC - nml PVT PVT URI symptoms NONE 1
0166226 02/28/2001 MI 62.0 62 F 01/30/2001 This patient was admitted to the hospital, neurology consult. He had plasmapheresis 3 times. Then he was admitted to rehab at the hospital. Diagnosed with GBS, Hyponutremia, wound infect, leukocytosis, increased temperature Y Y U 12/04/2000 12/22/2000 18 PVT PUB Thyroid Breast cancer Allergy to horse serum, breast cancer, NIDDM, hypothyroidism, HTN 1
0166227 02/28/2001 MN 50.0 50 F 01/29/2001 Pain and swelling in both wrists, pain in both ankles and also swelling in right ankle. Acceleration of Lyme symptoms, tachycardia, onset of panic attack and more. Y Y N 04/19/1999 03/01/2000 317 HLA-DR4 (+) PVT OTH Synthroid, diltiazem Dormant or under treated Lyme disease; PCN and metal allergies Unspecified reaction~Typhoid Vi Polysaccharide (no brand name)~3~17.00~In Patient 1
0166228 02/28/2001 TX 16.0 16 F 02/05/2001 Focal seizure, (right-sided) for about 5 minutes following influenza vaccine. Parent reports EEG done at hospital. Y Y Y 01/22/2001 01/22/2001 0 EEG done at the hospital - no results PVT PVT Singulair, Flovent inhaler, Serevent inhaler NONE Stable asthma 1
0166229 02/28/2001 MN 1.25 1 .3 M 02/06/2001 Fever, seizure-like activity, 24 hours, post vax, PCV #2 on 10/30/00. Fever, seizure-like activity, 48 hours, post vax, PCV #3 on 1/31/01. Y Y 2 U 01/31/2001 02/03/2001 3 10/00 EEG-nml; 2/1 CBC-nml PVT PVT NONE NONE NONE Fever and seizure~Pneumo (Prevnar)~2~1.00~In Patient 1
0166219 03/01/2001 PA 19.0 19 M 02/23/2001 It was reported that a 19 year old male pt received a Fluzone SV '00-'01 vaccination on 11/22/00 at 18:00. Reportedly, by the end of December 2000, the pt developed an onset of transverse myelitis. Treatment of 5 day "burst" of IV steroids and oral steroids was given. The pt required 5 days of outpatient hospitalization. The pt's recovery status was not reported. Further information is requested. Y Y 5 U 11/22/2000 12/01/2000 9 MRI's; Spinal Taps; Blood work-results not provided OTH PVT NONE Attention deficit U2001004280 1
0166230 03/01/2001 UT 0.2 0 .2 M 10/26/2000 Seizures, lethargy, arching back. Autopsy gives cause of death as cerebral edema and anoxia. Other significant conditios: retinal hemorrhages and right retinal detachment. Y 09/14/1999 Y 1 N 07/21/1999 07/22/1999 1 PUB PUB NONE 1
0166231 03/01/2001 TX 27.0 27 F 02/09/2001 On 12/31/00, pt began "feeling funny". On 1/1/01, pt started feeling tingling in hands, food tasted funny. Weakness in arms and legs on 1/3/01 and taste gone. Seen by MD on 1/2/01 with headache and congestion. No fever, no ST. MD thought it was ? allergic reaction to Prilosec. Seen by MD on 1/3/01 with ptosis and weakness. Currently recovering. Subsequently, dx'd with atypical GBS involving cranial nerves in particular. Per doc 210316, patient almost completely recovered, but still with occasional extremely tingling and scalp pain. Follow up 07/06/2001: "Patient did not experience any illness with in 4 weeks prior to onset of GBS. Possible URI 2 weeks prior to onset. A final diagnosis of GBS has been made as : Demyelinating polyneuropathy poss atypical GBS." Y 10 U 12/19/2000 12/31/2000 12 Influenza and mono (-) MRI (-) CSF-increased protein PVT PVT NONE Acne; GERD 1
0166233 03/01/2001 KY 0.3 0 .4 F 02/23/2001 This infant started a temp on 02/15/01 of 103, rash on her right arm and neck. The rash was rough, hot, and the arm was swollen. The infant saw the doctor on 02/12/01 at 9 AM. She was admitted to the hospital on 02/15/01 in the evening, at 5 PM temp was 104.4. released on 2/18/01. Diagnosed with cellulitis Y 4 Y 02/14/2001 02/15/2001 1 Blood test, culture, chest x-ray, UA PUB PUB 02/18/01 Double Resp Infection KY2001014 1
0166237 03/01/2001 CA 0.2 0 .2 M 02/12/2001 The vaccines were given at 10:30 AM, and the child started to cry inconsolably for 4-5 hours. During the last hour the child started to have jerking of his arms. The child was taken to the ER for evaluation. While in the ER the crying stopped, and the jerking movements decreased in frequency from every 2-3 minutes to every 5 minutes. When the crying restarted during the physician's exam the jerking movement increased. The ER physician believed that the jerking movements were seizures. The patient was given Ativan and admitted for observation. The following day the patient was seen by the neurologist and started on Phenobarbital. Y Y 3 Y 02/09/2001 02/09/2001 0 PVT PVT NONE NONE 1
0166238 03/01/2001 CA 73.0 73 F Rapid onset of leg weakness. Transverse myelitis and Guillain-Barre like illness with persistent neuropathy. Doubts it is from vaccine. Is improving. Also diagnosed with Urinary retention and constipation. Follow up: Final diagnosis (+) Guillain-Barre Syndrome. Diagnosis was made by a neurologist. The patient did not experience any other illnesses within the 4 weeks before onset of GBS. The patient did however experience severe subluxating joints and uneven gait before the onset of GBS. The patient never had GBS or a related illness. The patient has previously been vaccinated with influenza." Y 10 N 10/18/2000 MRI spine; EMG-nml PVT UNK prednisone, zantac, provera, premarin, lasix, glyburide, arover, feso4, calcium, folic acid, naproxen, glucosamine chondrotin Rheumatoid Arthritis Rheumatoid arthritis, NIDDM 1
0166239 03/01/2001 OK 66.0 66 F 01/29/2001 This patient had Pneumovax administered on 01/22/01, at approximately 1:30 PM. A few hours later the patient noticed discomfort (achy) in the left arm, became "feverish", felt "achy". She called the MD after contacting the health dept and complained of rapid heart beat, light headedness, mild sternal chest pain, slight sob. She was admitted to the hospital on 01/23/01. The patient was placed on Ancef foe cellulitis of the left upper arm and aqua-K pad. The patient's sickness dramatically improved and the patient was discharged on 01/26/01. Y Y 3 Y 01/22/2001 01/22/2001 0 Temp 99.2, Pulse 104, BP 150/80.2 dimentional echocardiogram and persantine stress test - R/O Myocardial Infarction. White count 8700. PUB PUB Diovan, Diltiazem, Loped, Estrace, Ca+ Suppl. NONE Hiatal hernia/reflux disease, HTN, hyperlipidemia, degenerative disc/joint disease, history of allergic rhinitis and bronchospasm, allergies nifedipine, metaproterenol OK0103 1
0166241 03/01/2001 PA 56.0 56 M 02/12/2001 Received 1st shot on 3/10/99, 2nd shot on 4/8/99. In September, '99, I started feeling extremely light-headed and ill over my entire body. Temperature would drop to about 94F. Went to MD. It was so bad I couldn't function in early October, I was in the hospital for 4 days. Could find no problem. Dx'd with Lyme disease in July, 2000. Still being treated. Diagnosis in hospital was also intermitant chest pressure. Follow up report: "According to the nurse at the doctor's office, the lot # was not recorded." Y Y 4 U 04/08/1999 09/07/1999 152 Blood tests revealed that the Lymerix vaccine activated the Lyme bacteria in my system PVT PVT NONE NONE NONE 1
0166242 03/01/2001 NY 55.0 55 F 11/27/2000 I went to the MD for a blood pressure check on 5/5/99 and received Lymerix vaccine, Lot LY12069. The 2nd one was given on 6/16/99, lot LY120A9. I was in bed the rest of the day with flu-like symptoms. I am starting therapy again at the hospital on 11/28/00, 2nd time. I lost the use of my hands and strength in arms. All my joints hurt. Have had 2 years of MD visits. 60 day follow up states patient experienced fatigue. Y N 06/16/1999 06/16/1999 0 X-rays of hands; Blood work-no arthritis; no kidney or liver disease; no Lyme disease; no heart disease or cancer and no thyroid disease. PVT PVT Lopressor Flu-like; joint pain; weakness 1
0166243 03/01/2001 NY 59.0 F 02/07/2001 The pt developed arthritis in September of 1997. The pt was in a testing group for a vaccine for Lyme Disease. Y N 09/10/1997 NONE OTH OTH NONE NONE NONE 1
0166244 03/01/2001 MD 1.2 1 .2 M 02/09/2001 Lost language, lost eye contact within weeks. Lack of further language and social development. Had a significant development regression that began 14-15 months of age. Developed odd, repetitive behaviors and self-stimulatory behavior. Developed chronic constipation at 14 months of age. By 9/16/98, pediatrician thought he was Autistic and he was sent to another doctor and another, who dx'd him with Autism. Doctor's exam showed he was unable to walk, had few words. Treatment: Secretin infusions; nutritional/vitamin supplements; ABA (Lovass Discrete Trial Program 40-55 hours per week); Auditory integration therapy; Greenspan Floortime Therapy; Speech therapy; Occupational therapy; Gluten and Casein Free Diet. Y N 02/23/1998 03/01/1998 6 EEG, blood tests, speech language evaluations, psychological testing, neurologist evaluation PVT PVT NONE 1
0166245 03/01/2001 CO 55.0 55 M 01/22/2001 Post vaccination this patient's arm was swollen, problems breathing, about 7 days post vaccination. On 11/06, patient went to the hospital for congestive heart failure, arm was red and swollen big as a grapefruit. The patient had vaccination on Friday. On Saturday, red arm, and breathing problems. Friday hard, fine breathing. Monday, saw a doctor was sent to the hospital for ischemia, blockage of blood flow, tissue damage, ex- clot tissue basically dead tissue. Tissue damage as a result of seeing myocardial infarction tissue. The 60 day follow-up states that the pt says that he is disabled since this incident. Pt has had a previous "heart attack" 13 years prior to this incident. Y N 10/27/2000 10/28/2000 1 Culture clot-basically dead tissue as a result of MI OTH PVT NONE Borderline Diabetic 1988 Heart attack CO00030 1
0166246 03/01/2001 KS 39.0 39 M 02/12/2001 This patient has headache, body aches, flu-like symptoms, bowel problems; patient also reports same symptoms post 4th shot 01/08/00. Diagnosed with perforated colon 4/14/2000, corrective surgery performed. Also diagnosed with fibromyalgia. Follow up: Patient did not recover from adverse event. Patient experiences extreme fatigue, joint aches, headahces, arthritis in spine. Hyper allergenic, continuing intestinal problems. Patient's current duty status is full duty, however approximately 60 days of work has been missed. The patient has not been evaluated by a physician or health care provider for this event. Patient did not receive any further shots since reported event." Y 06/25/1999 06/29/1999 4 NONE MIL MIL NONE NONE NONE 1
0166247 03/01/2001 MN 1.5 1 .6 M 02/09/2001 This child had a fever of 103 F axillary approximately 12 hours after his shots; duration approximately 36 hours developed vomiting 2 days later with loose diarrheal stools 24 hours after vomiting. Diagnosed with URI and RADM on 02/02/01. Y 01/26/2001 01/26/2001 0 NONE PVT PVT NONE NONE Facial eczema, pneumonia, hospitalization. 1
0166248 03/01/2001 NC 0.6 0 .6 M 02/14/2001 Two days after this infant had his vaccines, he awoke from a nap (was in grandmothers lap) suddenly back "limp", with loss of consciousness. No tonic-clonic activity. No apnea of cyanosis. The infant felt hot, but no documented fever. This lasted 1-2 minutes, normal afterwards. Neg exam by me shortly after the episode. No problems since the episode. Y Y 11/13/2000 11/15/2000 2 CBC - Nml. PVT PUB NONE NONE 1
0166249 03/01/2001 IL 63.0 63 M 10/09/2001 Report 2001004896-1 describes polyarthritis in a 63 year old male who received Lyme disease vaccine (Lymerix). On unspecified dates, the vaccinee received Lymerix vaccine. As of 02/20/01, the outcome of the event was unknown. Human leukocyte antigen (HLA) typing by polymerase chain reaction PCR was negative for HLA-DR4. The adverse event of "arthritis" does not meet ICH serious criteria, but is be submitted as an expedited report by special FDA request per the 06/28/00 letter. The most recent info was received on 09/18/2001. The vaccinee was last seen by the physician on 04/20/2001. At that time, the vaccinee continued to experience polyarthritis which was treated with methotrexate. The follow-up info received on 09/18/2001 states that human leukocyte antigen typing by polymerase chain reaction was negative for HLA-DR4. The vaccinee was last seen by the physician on 04/20/2001. At that time, the vaccinee continued to experience polyarthritis which was treated with methotrexate. The follow up states the vaccinee was last seen by the physician on 1/21/02. At that time, the physician indicated a diagnosis of seronegative rheumatoid arthritis. This resovled with corticosteroid therapy and subsequent addition of methotrexate. He had been tapered off his steroids without difficulty. He also had advanced osteoarthritic changes of his knees and received hyaluronic acid (synvisc) in one knee without relief. However, the knees had gradulaly gotten better "on their own." Medications at that time included methotrexate 10mg weekly, Naprosyn 500mg twice daily, folic acid 3mg daily, and prevacid 30mg daily as needed. On physical examination, he had no palpable skin lesions. Joint examination revealed mild osteoarthritic changes of his hands. Otherwise, he had no palpable synovitis, erythema, tenderness or diminished range of motion in any peripheral joints. The physician's assessment was "seronegative rheumatoid arthritis. Doing well on current therapy with the exception of probable methotrexate-induced stomatitis." Folic acid therapy was discontinued and the physician prescribed folinic acid 5mg once a wee, 24 hrs after his methotrexate dose. The most recent info, received on 2/25/02, indicated that the seronegative rheumatoid arthritis and osteoarthritis persisted as of 1/21/02. Both had improved. Y N 05/10/2000 12/25/2000 229 B-met normal; liver panel normal; antinuclear antibody 1:320; erythrocyte sedimentation rate 38mm/hr; full blood count normal; HLA DR4 by PCR negative; rheumatoid factor negative MIL OTH UNK UNK UNK 20010048961 1
0166250 03/01/2001 MN 55.0 54 M 03/21/2001 Report 2001004923-1 describes joint stiffness in a 55 year old male who received Lyme disease vaccine (Lymerix). The patient received his first injection of Lymerix on 11/19/99. He received his second injection of Lymerix on 12/20/99. "Within a few months" of receiving these injections, he began to experience soreness and stiffness in both wrists and the right elbow. He received no treatment for the soreness and stiffness. The stiffness and soreness persisted. The patient received his third injection of Lymerix on 11/17/00. As of 02/05/01, the soreness and stiffness in his wrists and right elbow persisted. The patient stated, "It has continued and seems chronic". The vaccine provider submitted this report directly to VAERS. The adverse event of joint stiffness and joint soreness do not meet ICH serious criteria, but is be submitted as an expedited report by special FDA the 06/28/00 letter. N 12/20/1999 01/20/2000 31 PUB PUB 20010049231 1
0166251 03/01/2001 ID 53.0 2 .6 M 02/16/2001 This patient received two of three shots while working for the forest service in Missouri. He was vaccinated with Lymerix to prevent Lyme disease. The patient started experiencing muscle aches and joint pain after his 2nd shot. He is continuing to experience similar pain off and on as well as shortness of breath. N 12/01/1999 01/02/2000 32 OTH OTH Hytrin for blood pressure. NONE NONE 1
0166252 03/01/2001 MA 1.5 1 .5 M 02/15/2001 This child had a very large local reaction on his thigh with bruising. It was first noted the evening of the vaccination in the bathtub. His thigh was red, hot, swollen through visit today 02/15/01. Warm compresses applied past few days. Y Y 02/12/2001 02/12/2001 0 PVT PUB NONE NONE Frequent otitis media. 1
0166253 03/01/2001 NH 0.3 0 .4 F 02/12/2001 This infant had a fever of 104.7 F, resolved within 15 hours. Y 02/08/2001 02/09/2001 1 NONE PVT PUB NONE NONE NONE 1
0166254 03/01/2001 OK 0.4 0 .3 F 01/18/2001 This infant was crying, inconsolably for 48 hours after her vaccination. Y Y 01/16/2001 01/16/2001 0 NONE OTH PUB Synagis Lot number 910201 Acute viral nasopharyngitis. Bronchopulmonary, dysphasia OK0101 1
0166255 03/01/2001 OH 1.0 1 .0 F 02/01/2001 This child had a rash on her head (pustular lesions), face, arms,and trunk. Her face was swollen, low grade temp 98.5 (ax), itching. Onset this AM. Given a prescription for Atarax and recommended Aveeno baths. Y Y 01/19/2001 02/01/2001 13 PVT PVT NONE NONE 1
0166256 03/01/2001 PA 0.5 0 .5 M 02/09/2001 This infant had a fever of 104.5 (Tmax) for 48 hours. Within a few hours after administration of vaccines and excessive fussiness. At 48 hours, exam is consistent with right otitis media. Y 02/07/2001 02/07/2001 0 CBC w/ Diff and Culture, U/A & Culture. PVT OTH 1
0166257 03/01/2001 ND 41.0 41 M 01/08/2001 Pt reports malaise, subjective fevers, backache and left arm heaviness, after 1st dose. This occurred 1/2 day, post vax. No serious reaction. Exam normal. N 01/05/2001 01/05/2001 0 MIL MIL Centrum multivitamins NONE Seasonal allergies (hay fever and pollen) 1
0166258 03/01/2001 PA U 02/26/2001 Report 2001004892-1 describes joint pain in a vaccinee of unspecified age and gender who received Lyme disease vaccine (Lymerix). On unspecified dates, the vaccinee received the first, second, and third doses of Lymerix. Following the third dose of Lymerix, the vaccinee experienced joint pain. As of 02/20/01, the outcome of the event was unknown. The adverse event of the "joint pain" does not meet ICH serious criteria, but is being submitted as an expedited report by special FDA request per the 06/28/00 letter. U MIL OTH 20010048921 1
0166259 03/01/2001 30.0 M Fifteen to seventeen hours following the patients immunization he awakened suddenly with nausea, stiff neck and pain in back. It resolved in approximately 12-15 hours. The patient reported 12 days later. Y 01/09/2001 01/10/2001 1 NONE MIL MIL Verapansil, ASA, Atenolol, Paroxetine NONE Patient has known med controlled A-Fib. 1
0166260 03/01/2001 OK 55.0 55 F 01/29/2001 On 1/27/01 the pt experienced a sudden onset of severe abdominal pain, cramping with nausea, dizziness, weakness and headache, unable to sleep at night. On 1/28/02, the pt experienced a headache, weakness, nausea vomiting, with confusion. The pt also experienced a fast heart rate, felt like I was going into coma. The pt took Motrin for the headache. The headache continues with weakness, joint pain. N 01/24/2001 01/27/2001 3 UNK UNK OK0106 1
0166261 03/01/2001 DC 52.0 51 F 02/07/2001 10 days post vaccine, broke out in rash, blistered, itchy. Rash lasted about 2 weeks. No PCP visit or tx. Patient had 2nd Varivax on 2/21/01. No reaction as of 2/28/01. Y 11/20/2000 11/30/2000 10 PVT OTH HRT NONE Allergy to PCN 1
0166262 03/01/2001 VA 66.0 66 M 01/29/2001 Pt developed new onset, severe eczema starting several days post the influenza vaccine, in Oct of 2000. Despite attempts to treat this generalized, very itching, scaling rash, very dry skin, problem remains. N 11/15/2000 11/22/2000 7 MIL UNK Membrane-Sclerosis, Glomerulonephritis. Asthma, COPD 1
0166263 03/01/2001 MA 45.0 45 F 02/12/2001 L shoulder rotator cuff tendonitis, resulting in frozen shoulder. N 11/01/2000 11/08/2000 7 NONE PVT PVT NONE NONE NONE 1
0166264 03/01/2001 OK F 01/25/2001 Pt reports on 1/22/01 between 2-2:30pm - at 2am SOB, itching face, stomach, arms, legs,hives. Fast heart rate, went to ER was prescribed Prednizone, O2, inhaler breathing machine, Heparin lock to slow heart rate and breathing. Also pepcid, Rx for Prednizone, Atarax for itching. Y Y 01/22/2001 01/23/2001 1 CxR and blood work. PUB UNK Asthma OK0102 1
0166265 03/01/2001 IL 73.0 73 U This patient had a small purple-red rash (vasculitis type) on arms, legs and feet edema. Y U 01/23/2001 01/28/2001 5 PVT OTH No acute illness CAD, HTN, Elevated Cholesterol, Osteoarthritis. 1
0166266 03/01/2001 CA M Vaccines given 11/29 @ 10:45, on 11/29 @ 1pm pt was being taken out of car seat by mom, eyes appeared glazed, body seemed tense, a lot of saliva and choking, no color change, no tonic clonic movements, 911 was called. Test were done all within normal limits. CT, and ECG NL. Y Y 11/29/2000 11/30/2000 1 CT head negative,ECG negative, CBC normal PH normal PVT PVT NONE NONE 1
0166267 03/01/2001 AK 3.0 3 F 01/02/2001 Warm, painful, swollen, red spot at injection site, only about one inch in diameter and left a bruise after a week of the symptoms. Y 11/29/2000 12/12/2000 13 PVT PUB NONE NONE 1
0166268 03/01/2001 SC 34.0 F 02/01/2001 Pt complained of itching. Epinephrine was administered at the center. Y Y 01/16/2001 01/16/2001 0 OTH OTH NONE NONE NONE 1
0166269 03/01/2001 CA 24.0 24 M 01/30/2001 Pt reports muscle aches at injection sites as well as headache and general malaise, for first 72 hrs. Followed by upper respiratory congestion, sore throat times 1 week. Resolved and recurrent 4 days later to present cough and chest congestion. U 01/09/2001 01/09/2001 0 PUB PUB NONE NONE 1
0166270 03/01/2001 TX 0.8 0 .9 M 02/26/2001 2 days post Hib vaccine administered (2nd dose) developed rash on legs. Within 2 days it was all over both legs, in 2 more days it covered both arms. Lasted 2 1/2 weeks. Y Y 12/27/2000 12/29/2000 2 PVT PVT NONE NONE NONE 1
0166271 03/01/2001 WA 1.75 1 .7 M 02/06/2001 Reported symptoms a bump on right deltoid at site of DTP given 2 weeks ago. Pt ambulatory and neurologically intact . Think this is minor reaction to DTP. Y 01/12/2001 01/17/2001 5 NONE indicated, but will re-examine. PUB OTH NONE NONE 1
0166272 03/01/2001 NY M Pt reports tenderness at injection site left deltoid. Then developed sore throat, swollen left side neck glands. Y PUB PVT Pain NONE 1
0166273 03/01/2001 CO 13.4 13 M 02/13/2001 Gave MMr with Biojector, Td by injection. Pt's color turned pale, c/o dizziness and abdominal pain. Put pt's head on knees, had him breathe deep and slow. gave pt juice after 10 minutes. Pt left feeling WNL. Mom fed him chicken nuggets and milkshake at McDonalds, pt got ill in evening, vomited times 2, had temp 101, c/o headache and abdominal pain. ER nurse told her to treat with Advil and Tylenol. 02/12/2001 02/12/2001 0 PUB PUB CO0102 1
0166274 03/01/2001 IL 1.5 1 .5 U Punctate Lesion at injection site and a 3 inch by 4 inch area of warmth and redness. Y 01/25/2001 01/26/2001 1 PVT PVT NONE NONE NONE 1
0166275 03/01/2001 OK 17.0 17 M 01/31/2001 Pt reports 30 minutes after injection, severe migraine - like headache. 1/31/01 headache continues, back of neck sore/stiff, sore throat, sensitive to light, left side of body sore. 2/1/01 headache continues, other symptoms resolved. Pt went to school today. Y 01/30/2001 01/30/2001 0 UNK UNK OK0105 1
0166276 03/01/2001 OK 4.0 4 F 01/25/2001 Pt complained of redness to injection site right deltoid, started evening of shots. Last night fever to arm and pt with fever of 100. Referral to Dr made 1/25/01 for treatment of possible infection. U 01/23/2001 01/23/2001 0 PUB OTH OK0104 1
0166277 03/01/2001 CO 55.0 55 F 01/31/2001 Pt reports gradual swelling of arm, starting 1st day, 4 to 6 days post shot, arm black and blue. Saw physician received steroid shot, No temp elevation. Four days later face swollen received injection for that then had trouble swallowing. When she bends over face gets hot and bright red. Pt is still on antibiotic with continued symptoms. Y Y 12/26/2000 12/27/2000 1 Has lab work 1/27 and 1 time earlier in Jan. PUB PUB Smashed thumb NONE CO0101 1
0166278 03/01/2001 TN 12.0 12 M 02/26/2001 Pt reports 41/2cm times 33/4cm of erythema, induration and heat to left deltoid muscle on 2/22/01, mild pain, redness. Treatment - local heat, massage, Benadryl, Ibuprofen. Y Y 02/20/2001 02/21/2001 1 NONE PVT PVT NONE No illness, 12 year physical NONE 1
0166279 03/01/2001 MA 4.0 4 F 02/23/2001 Hives on face, neck, chest, back arms, and legs began night after vaccination, spread over 2-3 days, treated with Benadryl. U 02/21/2001 02/21/2001 0 NONE PVT OTH NONE NONE NONE 1
0166280 03/01/2001 WA 0.08 0 .0 M 03/22/2001 Pt reported post 1 day shot - cutaneous semi- circular erythema line developed, below injection site. After 2nd Hep B same thing happened. These cutaneous lesions are smooth (left thigh) and haven't faded in 4 months. U 10/03/2000 10/04/2000 1 NONE PVT PUB NONE NONE 1
0166281 03/01/2001 MO 4.0 1 .1 F 02/15/2001 Pt reports started with spots on 2/14, now today 2/15, 10-15 on torso and about that many between both legs. Low grade fever. Y 06/10/1997 02/14/2001 1345 NONE PVT PUB NONE Resolved otitis media NONE 1
0166282 03/01/2001 NJ 54.0 54 F 02/13/2001 Pt reports having a fever with chills and headache, left arm pain at injection site on 2/4. The Left arm swelled with erythema(deltoid) and traveled to mid-bicep. Edema continued down to mid forearm. Pt was seen 2\8 deltoid, mid-bicep mild erythema, edema, no further pain. Y 02/02/2001 02/04/2001 2 NONE PVT UNK Glucosamine sulfate with condition. NONE NONE 1
0166283 03/01/2001 OR 1.0 1 .0 M 02/14/2001 Pt broke out in rash, started with red bumps, turning into blisters especially on face and genitals. Advised aveeno bath, baking soda paste, tylenol if feverish and benadyl cream. Y 01/24/2001 01/30/2001 6 PVT PUB NONE NONE NONE 1
0166284 03/01/2001 MI 33.0 32 F 02/15/2001 Pt reports hot and cold flashes, dizziness, vision,nausea, headache,arthralgia. Developed chest pain and dyspnea. Seen in ER given fluids IV and IV anti emetics. Y N 12/22/2000 12/23/2000 1 CBS, Comp.met. panel,ArVA, sed rate, chest x-ray, EKG PUB PUB Restoril, Cloniper, Diazide, Ultram NONE PCN, Amoxicillin, Zomiq, Imitrex 1
0166285 03/01/2001 KY 16.0 16 F 02/20/2001 Pt was sitting in chair by desk, TD given IM rt arm,Hep B give IM, pt says "I feel sick", paleness developed, non- responsive for few seconds. Left arm was drawn upward Pt came to, ambulated to exam table to lie down, pt reported being nauseated. B|P 120/86, pulse 80, LOC minutes, B/P 110/80. PMD notified Pt under observation at his office. Y U 02/20/2001 02/20/2001 0 PUB PUB KY2001013 1
0166286 03/01/2001 OK 48.0 48 F 02/12/2001 Pt reported difficulty breathing - extreme, heart beat racing - extremely fast, severe rash, weak, shakening - bad, still having difficulty breathing - tired, 2/13/01. Y U 01/22/2001 01/23/2001 1 Nothing attached except vaccine's given. PUB OTH NONE 1
0166287 03/01/2001 CA 7.0 7 M 01/31/2001 Pt started on rabies vaccine prophylactic when dog not at first available for observation post dog bite .Given on 1/22, 1/25, 1/29. Had nausea after 1st two shots times 1 hour. 3rd shot had initial nausea, then 10 hrs after shot, felt weak, dizzy, achy, couldn't walk; had possible seizure, eyes rolled up, body tremor, T100.3. Seen in ER. Y Y 01/29/2001 01/29/2001 0 H/H 35.5, WBC 11.1 (845,9L,7m), head CT scan negative. OTH UNK NONE Hx of CMV infection at 3 months of age. 1
0166903 03/01/2001 MI 46.0 46 M 03/01/2001 Pt reports morning post vaccine woke up with left arm hurting at injection site and front of arm. Redness times 3 weeks, pain spread down front and back of arm. Currently complains of marked weakness in arm an pain when rotating arm. Y U 01/05/2001 01/06/2001 1 PUB PVT 1
0166289 03/02/2001 NC 27.0 27 F 02/23/2001 Pt presents with c/o swelling and pain to LUE. Moderate amt of swelling to L deltoid with area of in 40 x 30mm thats radiating heat. Reports a constant pain. When movement attempted to raise arm limited ROM. Afebrile, Reports onset 2/21/01 pain easing of. Referred to OHS. Y Y 02/21/2001 02/21/2001 0 PUB PUB PPD NONE 1
0166290 03/02/2001 NJ 38.0 38 M 02/21/2001 Urticarial rash, pruritis. Y Y 02/20/2001 02/20/2001 0 OTH OTH Not taken recently Ventolin inhalant, PRN. Asthma 1
0166292 03/02/2001 CA 0.73 0 .7 M 12/13/2000 Single seizure episode next morning at 11am, child napping, mother heard noise checked on child, baby was shaking, eyes rolled back lasting aprox. 1 min after mother entered room. Paramedics were called and transported child to Hospital. Y U 11/29/2000 11/30/2000 1 Ct scan head 12/7/00, EEG scheduled 12/13/00, CBC, Comprehensive metabolic panel, magnesium. PVT OTH NONE NONE NONE 1
0166293 03/02/2001 OH 9.0 9 M 02/15/2001 Pt reports left arm swelling, pain, tenderness, red streaks, fever. Placed on Amox, Augmentin. Y 02/13/2001 02/14/2001 1 PVT UNK Tegretol, Nasalcrom, Flonase. NONE Seizure disorder, sinusitis (recurrent) 1
0166294 03/02/2001 MA 32.0 33 M 02/09/2001 Local erythema, warmth, tenderness, general malaise, low grade fever. Y 02/07/2001 02/08/2001 1 PVT OTH Glucophage, Ibuprofen Diabetes NONE 1
0166295 03/02/2001 NY 49.0 51 F 02/22/2001 Pt reports severe pain at site of injection, throbbing and tingling on surface of left hand. Y U 12/07/2000 12/07/2000 0 OTH OTH 1
0166296 03/02/2001 NY 49.0 48 M 02/22/2001 Pt reports edema of face, fever, chills,headache, fatigue, sore throat. Y 11/20/2000 11/20/2000 0 OTH OTH NONE 1
0166297 03/02/2001 NY 25.0 F 02/22/2001 Erythematous, edema L deltoid. Y 11/28/2000 11/28/2000 0 PUB PUB NONE 1
0166298 03/02/2001 KY 1.6 1 .6 M 02/12/2001 Swelling and redness, Rt thigh injection site, 6x12 area. Y Y 01/30/2001 02/01/2001 2 PVT PVT NONE 1
0166299 03/02/2001 MA 20.0 20 F 02/15/2001 Pt reports local burning and pain with administration followed by L upper arm pain and swelling, with deep red macular area at injection site of 4.5x5.5cm. Pt complains of pruritis and fever. Y U 02/07/2001 02/07/2001 0 NONE OTH PUB Minor trauma to L leg NONE 1
0166300 03/02/2001 CT 33.0 33 F 02/14/2001 Pt reports swelling, edema, pain plus erythema,plus indurate. negative d/c negative paresthesia. Y 02/12/2001 02/13/2001 1 NONE PVT PVT NONE Laceration face Penicillin/macrobid 1
0166301 03/02/2001 OH 5.0 1 .6 F Pt's mother reported to Dr office 2/2/01 that pt has chickenpox 80-100 spots, red spots blisters and scabs. Y 06/10/1997 01/29/2001 1329 PVT PVT Serous otitis media, probable viral pharyngitis. 1
0166302 03/02/2001 WA 0.2 0 .2 F 02/15/2001 Mother reports 24 hrs post shots, pt crying, vomiting,staring spells. 36 hours post shots crying, high pitched abnormal inconsolable crying for 5-6 ours. 48 hours post shot, fussy but normally fussy. 56 hours post shots, normal for her. No fever,no redness or soreness at injection site. Y 12/13/2000 12/14/2000 1 NONE PUB PUB NONE NONE NONE 1
0166303 03/02/2001 VA 2.0 2 .7 F Large localized reaction right upper thigh at 6 hours post, resolved by 48 hours. Y 02/12/2001 02/12/2001 0 NONE MIL MIL NONE NONE 1
0166304 03/02/2001 AL 72.0 71 F 02/16/2001 Pt reports red swollen area to right arm at injection site. Y Y 02/14/2001 02/14/2001 0 PVT PVT NONE Hypercholesterolemia 1
0166305 03/02/2001 AL 67.0 67 F 02/15/2001 Pt reports red, swollen and painful at injection site. Y 02/14/2001 02/14/2001 0 PVT PVT NONE Arterial Hypertension 1
0166306 03/02/2001 CA 4.9 4 F 02/14/2001 Arm painful less than 24 hours, red, swollen, warm to touch, induration 9x9cm 24 to 48 hours. Pt treated with Benadryl, Tylenol Q4 hrs. U 02/12/2001 NONE PVT PVT NONE NONE 1
0166307 03/02/2001 OR 1.0 1 .0 F 02/14/2001 High fever (103). Small erythematous papules without erythema or exudate. Y 11/13/2000 11/22/2000 9 PVT PVT NONE NONE 1
0166308 03/02/2001 OR 1.08 1 .0 F 02/09/2001 Broke out in rash last night on back and mouth, turning over course of day to blisters. Advised to use aveeno bath, benadyl cream and tylenol if fever. Y 01/30/2001 02/08/2001 9 PVT OTH NONE NONE NONE 1
0166309 03/02/2001 WI 19.0 19 F 02/14/2001 Pt reports red, swollen induration at injection site, persisting 3 weeks so far. Pruritic, no vesicles. 01/16/2001 02/08/2001 23 PVT PVT Zoloft, Levisin NONE 1
0166310 03/02/2001 NY 65.0 64 M 02/16/2001 Hives Y 03/14/2000 06/17/2000 95 PVT UNK NONE 1
0166311 03/02/2001 DC 10.0 10 F 03/20/2001 Pt received TD booster, post vaccine pt stood to leave, became dizzy, diaphoretic and pale. Afebrile, heart rat/BP, pulse ok and blood sugar stable. After 10-15 minutes child recovered completely visual signs remained stable. Pt received PO fluids and tylenol for headache. 24 hour phone follow-up no repeat episodes. Y 02/16/2001 02/16/2001 0 NONE OTH OTH NONE Mild flu symptoms times 1 day, myalgia, and headache. NONE 1
0166312 03/02/2001 MA 0.5 0 .6 M 02/14/2001 Area of erythema and induration, also warm on left thigh, about 4x5 cm. Y 02/13/2001 02/14/2001 1 NONE PVT PUB NONE NONE 1
0166313 03/02/2001 NC 78.0 70 M 03/01/2001 This patient had Pneumovax in 1993. He was admitted with pneumococcal pneumonia with septic shock and positive blood cultures. Y Y Y Y Y 12/09/1993 02/19/2001 2629 Positive blood culture - Strept pneumonia PVT PVT Hismanal, dexamethasone, Uniphyl, Moduretic, Ventolin, Atrovent, Azmacort Hypertension, COPD Hypertension; COPD 1
0166314 03/02/2001 CA 0.5 0 .5 F 02/23/2001 This is a 6 month old infant; who the family presents to the pediatrician with complaints of seizure type jerking activity that the parents characterize which is consistent with infantile spasm with flexure spasms of the body, 1-2 days after vaccination. Y Y N 02/12/2001 02/13/2001 1 EKG-Hypsarrhythmia (infantile spasms) PVT PVT 1
0166315 03/02/2001 VA 0 .8 M 02/17/2001 At 12 month, began losing 3 work vocabulary. At 12-24 months, increasing gastrointestinal problems. At 27 months, dx'd with Autism. At 33 months +; clinical trials; fat soluble, vitamin A, later, followed by bethanechol, supplements, chelation. The 60 day follow-up states that the pt has autism; multiple mental totoxicity especially mercury. The pt's partent states that the pt was poisoned by thimerosal HB and was disabled by the pertusis vaccine. Y N 11/11/1996 01/01/1997 51 Vit A and D, elemental hair analysis, DPT and MMR titers, Mercury challenge test, chelation, IgG allergy assessment, etc. PVT OTH NONE NONE Mercury toxicity, autism.~Vaccine not specified (no brand name)~~1.00~In Patient 1
0166316 03/02/2001 CT 45.0 45 F 02/23/2001 The pt received her 1st injection of Hep-B vaccine on 1/25/01. That evening, she presented to the local ER with shortness of breath, itching and a rash. She was sent home from the ER. She returned to the ER, 24 hours later, on 1/26/01. She was hospitalized for 3 days. The dx and outcome of these events were not provided. F/U rec'd from treating physician on 3/9/01 indicated that the pt underwent unspecified allergy testing which was positive for allergy to hepatitis B vaccine. The outcome of the event was not specified. Y Y 3 U 01/25/2001 01/25/2001 0 OTH OTH 20010049361 1
0166317 03/02/2001 KS 1.0 1 .0 M 01/02/2001 Child had fever on 5-24, 5-25 and 5-26 as high as 103F, then on 5/27, the fever broke but child broke out in generalized rash in scalp and all over body was itchy. Child was admitted to the hospital for observation with concerns of seizure. Mother states he just "looked right through you". Had a fixed stare while hospitalized. Released, the next day. Mother states, within 3 days, the rash was gone and he was doing ok. Y Y 1 Y 05/23/2000 05/28/2000 5 PUB PUB NONE KS200101 1
0166318 03/02/2001 PA 44.0 44 M 06/26/2002 The report describes "atypical" amyotrophic lateral sclerosis (ALS) in a 44 year old male who received Lyme disease vaccine. The pt was seen by a neurologist on 10/29/99. At that time, the pt reported "abnormal speech and swallowing for about 6 months." He reported that he felt as though he was choking, although he had not actually aspirated. He also reported "a somewhat vague slurring of speech" and "occasional fasciculations in his arm muscles". At the time of the neurology consultation, the pt was a construction worker and was "still able to do physical work without any difficulty." On physical exam, eye closure was noted to be "slightly weak bilaterally. The pt was unable to bury his eyelashes on either side and the eye could be pried open relatively easily." The physician noted possible tongue fasciculations without scalloping of the tongue border. Results of nerve conduction studies and EMG performed on 11/24/99, were "consistent with a dx of motor neuron disease." The neurologist stated, "this is probably ALS". The pt went hunting and developed cellulitis on his hand. He was seen by his PMD on 12/8/99 and reported sustaining a tick bite on his hand. The physician's impression was "cellulitis-resolved". A Lyme antibody titer measured on 12/14/99 was positive at 1.81. The pt was referred to an infectious disease specialist, who saw the pt on 1/28/00. The chief complaint noted was progressive twitching. The pt reported that he could no swallow liquids, but could swallow food. The pt also reported slurred speech. On physical exam, the physician noted twitching. The pt was treated with Rocephin. The pt was seen by the infectious disease specialist on 2/11/00; he reported that he could swallow water "well" and was twitching "on and off". The pt developed hives. On 2/18/00, Rocephin was discontinued and treated with Medrol Dosepak. On 2/22/00, the pt reported his swallowing was nml. On exam, the physician noted "rare" fasciculations of the upper arm with normal arm strength and his speech was still slurred. Before the study, the physician noted dysarthritic speech and "muscle fasiculations seen throughout, including tongue fasciculations." The pt saw a rheumatologist on 3/3/00, mostly for question of a dx of Lyme disease. At that time, the pt denied having any tick bites. The physician noted that the pt had been "dramatically better neurologically" one the 1st day of receiving IV Rocephin. The physician stated "his positive ELISA is likely related to vax. On 3/16/00, the pt was seen by a neurologist specializing in neuromuscular disease. This physician noted that the pt's first symptoms began in 8/99, "when he began to gag when he was brushing his teeth. Shortly thereafter, he began to develop twitches in his left arm." On exam, the physician noted "bilateral tongue and facial weakness with tongue fasciculations. He has fasciculations in all 4 extremities more so in the arms. Reflexes are pathologically brisk." The physician stated, I am afraid that the dx of ALS is inescapable." The pt saw another neurologist on 3/21/00 and he noted the pt "developed mild dysarthria in 9/99." He also noted that the pt received Lymerix in 9/99 and 10/99 (exact dates were not reported). It was not stated whether the mild dysarthria began before or after Lymerix. The neurologist stated, "He appears to have primary motor neuron disease, probably ALS. I do not feel that the Lyme vax is specifically related to these symptoms since these began in 8/99, before the vax." The pt was seen by another physician on 4/7/00. At that time, the pt reported that 1 week, post vax, of 2nd Lymerix, he experienced "trouble getting words out." The pt reported that his primary physician said the pt was "under stress" and prescribed Zoloft. On 4/10/00, the pt was seen by a neurologist specializing in ALS; noted "excessive laughing and crying" over the previous 3 months. From his exam, he believes the pt has fairly early bulbar-onset ALS. On 9/8/00, the pt saw another neurologist. Atrophy of the tongue, a forearm and thumb of left hand was noted. Jaw reflexes showed some clonus and upper extremities had spread, spastic catch, and bilateral Hoffman reflexes (4+). The neurologists dx was "amyotrophic lateral sclerosis with bulbar involvement. The pt was seen by this physician again on 10/00 and noted that the infectious disease specialist was treating the pt for Lyme disease with a 28 day course of IV Primaxin IV. The pt had been treated with Rilutek but stopped therapy prior to 10/10/00 because of "additional muscle twitching". The pt was asked to continue Rilutek. On 2/15/01, the pt's attorney reported that the pt had been "dx'd with an atypical ALS, triggered by vaccination." However, the medical records supplied by the attorney did not indicate such a dx. The attorney stated that it is currently unclear whether the ALS was caused by Lymerix; the pt was predisposed to develop ALS and the immunization triggered it, or the ALS was accelerated by IZ. The most recent information, received on December 5, 2001 did nor provide the outcome of the ALS. On 02/11/2002, in a statement of injuries, the vaccinee's attorney alleged that the vaccinee has experienced slurred speech, muscle twitching, weakness in his arms and pain at different points in his legs. The most recent info received on 02/11/2002 did not provide the outcome of the ALS. ALS is considered medically serious. The most recent information, received in 05/14/2002 incidated that the vaccines was becoming weaker on 08/09/2001. On 29 march 2001, the vaccinee was seen by a physician specializing in physical medicine and rehabilitation of muscular dystrophy. Medications at the time included Rilutek 50mg twice daily and zoloft 100 mg. The physician noted that "He has not been losing weight but is developing atrophy of the upper extremities. The patient is essentially averbal and eats foods of all consistencies but thin liquids appear to pool in the valleculae. He had stridor during VC (vital capacity) maneuver and no PCF." Manual muscle testing revealed shoulder strenght to be 3/5 bilaterally. Biceps strength was 4-/5 bilaterally, and wrist strenght was 3-/5 bilaterally. All other muscle groups were 5/5. Oxygen saturation ranged from 93 to 95. The physician's assessment was "the patient has bulbar ALS". His mild desaturation prior to cough maneuvers and clear symptoms of faucial pooling bear witness to chronic aspiration. Plan: the patient was counseled to cough whenever the Sa02 (oxygen saturation) decreases below 95%. A western blot performed on serum on 05/15/00 revealed a positive Lyme IgG (bands 93, 58, 45, 41, 39, 30, 28, 23, 18 present) and a positive Lyme IgM (bands 41, 39, 23 present). On 06/26/00, hte pt underwent a speech and swallowing evaluation. "The pt continues to present with mild oral dysphagia for solids and mild dysarthria. Swallowing difficulties were noted in all three phases of the swallow. Dysathria was characterized by mild slurring, reduced rate of speech, and mild distortions of lingua-alveolar and sibilant sounds. Vocal quality was judged to be mildly hypernasal with mildly reduced intensity and monotone pitch." Recommendations included a regular diet with thin liuids with strict adherence to aspiration precautions. Laboratory evaluation on 07/13/00 revealed a sedimentation rate of 3mm/mr. On 07/13/00 western blot performed on serum revealed a positive Lyme IgG (bands 93, 58, 45, 41, 39, 30, 28, 23 and 18 present) and a positive lyme IgM (bands 41, 39 and 23 present). lab evaluation on 08/19/00 revealed a positive hepaitits A virus Ab. Immunoglobulin M 218 and alkaline phosphatase 32. On 08/23/00, a thyroid scan revealed no significant findings and the thyroid uptake was 9.5% (reference range 6.0%-16.0%). The vaccinee was seen by another physician on 10/30/01 who noted that the vaccinee had spastic ALS with difficult swallowing, "twitching" muscles, "grossly adversely affected" speech and intact mentation. There is a possibility the vaccinee had chronic Lyme disease as evidenced by a positive western blot. The vaccinee was markedly debilitated. Plan of teatment included hormonal studies, vitamin C infusions and gluthathione. The vaccinee was advised to eat a high protein diet with steamed vegetables." On 11/03/01, the vaccinee had a "toxic element clearance profile" performed. This revealed lead 16.78me; 24hr (reference range <=9.30), arsenic 144.9meq/24hr (reference range ,=61.8), chromium 201.62 meq/24hr (reference range 16.27-108.44), copper 57.63meq/24 hr (reference range 1.34-54.62), manganese 4.760 meq/24 hr (reference range 0.072-1.233), nickel 8.45 meq/24 hr (reference range <=3.23), tin 32.35 meq/24 hr (,=6.18), titanium 477.7 meq/24 hr (reference range <=332.4) and tungsten 1.502 meq/ 24hr (<=0.997). This physician also indicated the test revealed some heavy metal toxicity. Medical records from the same physician indicated that on 11/08/01 the vaccinee was receiving electromagnetic therapy. After the first treatment, the pt reported his shaking was reduced and he felt better. Medical records indicated that on 01/03/02 the vaccinee was prescribed prednisone for a "bad rash." The most recent info, received 06/12/02, indicated that the vaccinee was feeling significantly better with better physical activity on 11/08/01. On 11 February 2002, in a Statement of Injuries, the vaccinee's attorney alleged that the vaccinee "has experienced slurred speech and gagging, as well as muscle twitching, weakness in his arms and pain at different points in his legs." Following the reported onset of ALS, the vaccinee experienced hypocholesterolemia, increased concetrations of aspartate aminotransferase and alanine aminotransferase, and a "bad rash" treated with prednisone. These events were not reported as adverse events due to vaccine administration, but were found during the course of review of the vaccinee's medical records. Therefore, they are not listed as adverse events. The most recent information, received on 03 October 2002, did not provide the outcome of the reported events. Information received on 12 June 2002 indicated that the vaccinee was feeling "significantly better" with "better physical activity" on 08 November 2001. ALS is considered manufacturer medically serious (OMIC). Y N 09/01/1999 Gastroscopy with biopsy on 8/24/99; Esophagus, cervical and GE junction-wnl; Vocal cords-wnl; Stomach had 3 small polyps; The pt had antral gastritis; MRI; Lyme antibody titer-positive; LP; PCR analysis of CSF-neg for Borrelia DNA; Gag reflexes-nml; UA-neg for Lyme antigen; Nerve conduction studies and EMG of left arm on 3/1/00. On 3/2/00, Lyme IgG and IgM by Western Blot-neg; PCR analysis of serum-neg for OspA gene; Lyme IgG and IgM by Western Blot on 5/1/00-neg; Cytological analysis of CSF-Negative for malignancy; Lyme IgG and IgM by Western Blot on 5/8/00-nonreactive. Aspartate trasaminase serum 52U/L; thyroid scan 08/23/00-no significant findings; thyrid uptake -9.5% (normal 6.0%-16.0%). Toxic element clearnance profile 24 hr Urine 11/03/01-lead 16.78me; 24hr (reference range <=9.30), arsenic 144.9meq/24hr (reference range ,=61.8), chromium 201.62 meq/24hr (reference range 16.27-108.44), copper 57.63meq/24 hr (reference range 1.34-54.62), manganese 4.760 meq/24 hr (reference range 0.072-1.233), nickel 8.45 meq/24 hr (reference range <=3.23), tin 32.35 meq/24 hr (,=6.18), titanium 477.7 meq/24 hr (reference range <=332.4) and tungsten 1.502 meq/ 24hr (<=0.997). OTH OTH Tinnitus since 02/99, outer hair cell abnormality, chronic gastritis, food getting stuck in esophagus 08/99, tongue fasciculation 08/99. Allergy to Penicillin and Ceftriaxone (hives). Right inguinal repair in 1976. 2001004346 1
0166319 03/02/2001 KS 1.2 1 .2 M 01/02/2001 Post vax, about 13:00, pt began low-grade fever and slept for a few hours. At 18:00, the same day, temperature was 101.8F and baby was shaky and trembling. Eye became fixed, color was blue and vomited. EMT's were called and took baby to ER. He had a chest X-ray to check for aspiration. Pediatrician was notified. He received 2 breathing treatments and started on Augmentin. He vomited 2 times, total. On 1/2/01, parents report baby is acting ok, today. Y Y 1 Y 12/28/2000 12/28/2000 0 Chest X-ray PUB PUB Zyrtec prn NONE NONE KS200102 1
0166320 03/02/2001 NC 0.2 0 .2 M 02/16/2001 Following vaccinations, the pt was crying, mother tried the bottle and pacifier, baby refused both. Mother placed the baby on the table to dress him and she noticed the baby was pale, diaphoretic, eyes closed and the baby had stopped crying and was limp. The color was ashen and bluish. 911 was immediately called. The infant then became floppy with left side circumoral cyanosis. Oxygen was applied. EMS arrived and administered their oxygen and then the infant began to cry and turned pink. The pt was transported to the hospital and then was released home that same evening. Y Y Y 02/15/2001 02/15/2001 0 PUB PUB NONE Prematurity (34 weeks gestation) NC01018 1
0166321 03/02/2001 TN 61.0 61 F 02/05/2001 After 2nd shot, began having respiratory problems, weakness, fatigue, swelling and pain in hands and arms, weight loss, skin on hands thickened and cracked. Treated for arthritis but no improvement. Sent to a Rheumatologist in July 1999 who dx'd as Autoimmune connective tissue disorder and he is treating it with Prednisone and Methotrexate and is still under treatment. Consulted my Internist about taking 3rd shot; once I took the 3rd shot, conditioned worsened; slow improvement now but activities are still limited by condition and still have all symptoms. Pt returned for her regularly scheduled visit today. She has an undifferentiated connective tissue disease manifest by evidence of inflammtory myopathy with anti-Smith antibody. This is most likely a lupus variant. She is doing remarkably well with the combination of low dose methotrexate and prednisone. Her prednisone has been tapered to 3 mg daily. Her methotrexate has been tapered to 10 mg every other Monday in rotation with folic acid. She has instructions to further reduce the prednisone over the coming months. She has now completed four years of Fosamax therapy for her bone mineral density abnormalities. She states that the DEXA performed after approxiametly 1 1/2 years of therapy showed improvement in bone mineral density. I believe she is due for another one now. This would serve as the baseline for a comparison DEXA to be performed three years from now to be sure that her calcium supplementation and exercise is adequate to mantain bone density off Fosamax. I am planning to see her back in about four months unless questions or problems arise. Pt is a 61 year old with a history suggestive of an evolving autoimmune inflammatory connective tissue disorder. Her symptoms were probably manifest as much as five years ago, but have blossomed more prominently in the last eight months. She has several symptoms and signs which render an overlap appearance to her disease. A definitive diagnosis cannot yet be made, but certain that her differential diagnostic list can be shortened significantly once some additional lab is obtained. Y Y Y N 07/30/1999 PUB PUB Fosamax, Premarin, Provera NONE Osteoporosis 1
0166322 03/02/2001 NM 49.0 49 F 01/08/2001 Pain and weakness in right arm and hand. Y U 09/07/2000 11/01/2000 55 PUB PUB Fibromyalgia Fibromyalgia, chronic back pain 1
0166323 03/02/2001 PA 37.0 37 F 02/16/2001 Joint pain and stiffness; soreness at injection site; fatigue; fever for 6 weeks; skin rash on back and buttocks; eye swollen shut; headache; backache which started in April 1999 until present. Received e-mail stating an address change; change made on 10/24/01. Y N 04/05/1999 05/03/1999 28 PVT UNK NONE NONE NONE 1
0166324 03/02/2001 CA 54.0 54 F 02/19/2001 One day of fever to 101.5F; onset mid-December of tingling in hand, arm pain on total body involvement by latter January. On February 12, dx'd with Sjogren's Syndrome. 60 day follow-up states that there is a new diagnosis of MCTD (Standford) not Sjogrens as previously reported. Doc 210790, annual follow up states the following: swelling (hands, legs, feet) athritis pain. Also states that patient was type I diabetic, had asthma and had thyroid. Y Y U 11/28/2000 12/15/2000 17 In pt's file PUB OTH Humalog, Premarin, Flovent, Plaquenil, Naproxen, Cortisone NONE Diabetes Type I, Hashimoto's Syndrome, asthma 1
0166325 03/02/2001 KY 1.25 1 .2 M 02/27/2001 Reported on 2/22/01 hives on face, on 2/23 low grade fever, blue looking nails, lips. Seen in ER 2/22 for urticaria given Elocon 1% ointment. Seen by Dr on 2/24 treated with Benadryl. Y Y 02/21/2001 02/22/2001 1 NONE PUB PUB KY2001015 1
0166326 03/02/2001 KS 1.0 1 .0 F 01/25/2001 Pt developed nausea and vomiting, fever, malaise the evening after immunizations were given 5-6 hours post injection. 4 days later cont. to recover, no fever, starting to take liquids without vomiting. Continues diarrhea, improved on 1/25/01. Y Y 01/22/2001 01/22/2001 0 PUB PVT KS200105 1
0166327 03/02/2001 MO 1.2 1 .1 M 02/23/2001 Pt broke out with chickenpox 2/22/01. Y 01/26/2001 02/20/2001 25 PVT PVT Augmentin, Albut nebs, Intal Serous L Otitis Media RAD 1
0166328 03/02/2001 GA 2.0 1 .0 F 02/23/2001 Pt developed macular erythematous rash on face and eyelids immediately following vaccine. No swelling, no respiratory distress. Pt received benadyl. Rash resolved 15 - 20 minutes later. Y 02/23/2001 02/23/2001 0 OTH UNK NONE NONE NONE 1
0166329 03/02/2001 NE 2.0 0 .2 F 02/20/2001 Non-stop crying for greater then 24 hours post vaccine. No fever, seizure, or other reaction seen. Child unconsolable for 24-36 hours then back to normal. Y 02/14/2001 02/14/2001 0 PVT PVT NONE NONE NONE 1
0166330 03/02/2001 PA 1.0 1 .0 F 02/22/2001 Pt developed rash 7 days post vaccine over entire body. 02/14/2001 02/21/2001 7 PVT UNK NONE 1
0166331 03/02/2001 MA 1 .3 M 02/22/2001 7x5cm area red, swollen and warm to touch. Left thigh. Y 02/15/2001 02/16/2001 1 PVT PUB 1
0166332 03/02/2001 MI 1.0 1 .0 F 02/22/2001 Pt received Hib, polio, and Prevnar on 2/20/01. Prevnar was given one time before, HIB and polio had 2 previous doses. Pt returned 2/21 with hives, red, sore, and itchy. Y Y 02/20/2001 02/21/2001 1 PVT PVT Intal, Xopenex NONE Premature 1
0166334 03/02/2001 OH 0.2 0 .2 F 02/23/2001 Pt crying for 9 hours non stop. Y Y 02/13/2001 02/13/2001 0 CBC, Cath UA, urine culture neg, all labs essentially WNL PVT PUB NONE NONE NONE 1
0166335 03/02/2001 KS 0.3 0 .3 M 01/27/2001 Multiple bulbous lesion At injection site. (not related to adhesive from band aid) Y Y 01/23/2001 01/24/2001 1 PVT UNK KS200107 1
0166336 03/02/2001 AL 1.0 1 .0 F 02/27/2001 Extreme irritability, fever, rash Y 02/14/2001 02/21/2001 7 NONE PVT PVT NONE NONE 1
0166337 03/02/2001 MA 1.08 1 .1 M 02/28/2001 One week post vaccine's pt developed a high fever between 103 -104.3 for 3 days. Fever resolved by noon, Sunday 2/25. Visited doctor and ER (per doctor's request) for fever. No vomiting or diarrhea, pt treated with tylenol and motrin. Y Y 02/15/2001 02/22/2001 7 PVT OTH NONE mild cold/congestion ~Measles + Mumps + Rubella (no brand name)~1~1.00~In Sibling 1
0166338 03/02/2001 WI 1.5 1 .5 F 02/28/2001 Mother reports 14 days post vaccine, pt had bruising. Pt was seen 2/20 by physician. Physician noted purpura, bruising 2nd petechia,. PH 39,000 (INR PT/PTT normal) 2/26 PH 26,000. No treatment currently. Report to follow. Y U 01/31/2001 02/20/2001 20 PVT OTH NONE NONE NONE 1
0166339 03/02/2001 WV 17.0 17 F 02/21/2001 Immediately after pt received vaccine, became unresponsive - unconscious. Pt was breathing and had steady pulse. Nurse used ammonia inhalant, pt responded to. Pt feel were elevated. Pt remained very drowsy but oriented. Pt was transported to ER for evaluation and released within 1 hour with dx of vasovagal response to vaccinations. Y Y 02/20/2001 02/20/2001 0 PUB PUB Depo provera NONE NONE WV0105 1
0166340 03/02/2001 NY 5.0 3 F 01/10/2001 Itchy rash over the body and face. No fever, pt was given Benadryl. Y 11/06/2000 11/09/2000 3 NONE PVT PUB NONE NONE NONE 1
0166341 03/02/2001 WV 1.5 1 .6 M 02/23/2001 Mother states right arm is swollen and red with blisters. Arm looks reddish and blue, mother thinks pt had low grade fever, but did not check. 02/21/2001 02/22/2001 1 PUB PUB NONE NONE WV0106 1
0166342 03/02/2001 VA 23.0 23 M 02/02/2001 Shortly after pt received vaccine said felt fine, got up to walk to chair, became pale, slumped forward with LOC, within seconds he began to convulse for approx 10-15 seconds. Soon afterward regained consciousness and was oriented times 3. Entire event lasted 1 minute or less. Pt was taken to ER by ambulance. Prior to immunization pt denied allergies, previous adverse reaction or seizure. Post the event pt said this had happened to him 2 times in his own country. Y Y 02/02/2001 02/02/2001 0 BP after seizure 84/64, P60 PUB PUB PPD skin test 0060P/LA NONE 1
0166343 03/02/2001 VA 1.25 1 .3 M 02/26/2001 Reported rash on face, neck and body (3days), Pt cranky. 2/21/ seen by physician and treated. Y 02/19/2001 02/19/2001 0 PVT PVT NONE 1
0166344 03/02/2001 PA 67.0 66 F 01/22/2001 Pt reports same day face distorted, swelling, pain, stiffness, shoulders,neck,ear,back, vertebrae,hip joints, legs,arms. Cannot walk without pain, cannot lift without pain. Pt had x-rays and 2 MRI's. Treated with Celebrex, did not eliminate pain. Predizone and Indocin helped but did not eliminate painful condition, physical therapy no help. Y N 07/17/2000 07/17/2000 0 x-rays MRI's PUB OTH NONE Puncture wound from fresh turkey breast bone 1
0166345 03/02/2001 NC 21.0 21 F 01/30/2001 On 1/24 pt's reports area swollen and sore, on 1/29 was draining pus, blood and yellow clear drainage. area remains swollen about size of golf ball 1/29. Pt was treated with Amox. Pt was to return in 2-3 days if warm, red or tender. Y 01/22/2001 01/24/2001 2 PUB PUB NONE NONE NKDA NC01017 1
0166346 03/02/2001 VA 4.0 4 F 02/26/2001 Post vaccine pt has increased swelling to left lower arm, also is red at injection site 1 1/2 inches. Full ROM at elbow, below elbow warm to touch. Y 02/21/2001 02/22/2001 1 PVT PVT NONE 4 year well check NKDA 1
0166347 03/02/2001 VA 1.33 1 .3 F 02/26/2001 Post vaccine leg swollen at injection site, spot, rash appeared itching body, no fever. On 1/29 F/U treatment given by Dr. Y 01/26/2001 01/26/2001 0 PVT PVT NONE Dry skin problem 1
0166348 03/02/2001 MA 12.0 12 M 02/12/2001 Pt became pale, lightheaded. B/P 102/44 P60, no SOB. Visual signs monitored for next 1/2 hour, range 100/40 to 108/60, P 60-84, R 16-24. Pulse became irregular. Pt complained of burning eyes, itching left ear, elbow, leg. Called EMS, taken to hospital, treated with Benadryl . Y Y 02/12/2001 02/12/2001 0 NONE PUB PUB NONE NONE NONE MA0102 1
0166349 03/02/2001 25.0 F Pt received a DT vaccine, at her left deltoid muscle site. 1-2 days later developed redness, swelling, pain at the injection site. Y 02/05/2001 02/06/2001 1 UNK UNK Left foot wound 1
0166350 03/02/2001 KS 1.4 1 .4 F 01/17/2001 This child had Motrin at 9:30 AM. She has taken Motrin before without any problems. At 12 noon she received immunizations. On arriving home around 3 PM she got a dose of Acetaminophen, also not new med for her. She slept 1 hour waking her ears and neck was bright red, and she had welts on her back extending up into her hair line. The mother consulted her doctor who ordered Benadryl which was given. Shortly thereafter the mother noticed the child had "blue lips" and labored breathing and severe hives over her entire body. She took her to the ER in Salina where she was seen by a doctor. Her condition improved and she returned home with instructions to give her Benadryl. The mother did this, and the child looked good the following AM without any hives. However, by 10:30 AM on 01/13/01, the mother noted hives again on her face, neck, and belly. She gave her appropriate dose of Benadryl, and the child slept for one hour. On awakening the child began screaming, and the mother noticed her hands and feet were swollen, so much that her toes were white. The mother took her to the ER again where the same doctor was attending. He started the child on a steroid medication, the mother is not sure the name of the med, and since that started the child's condition has returned to normal. The mother is still rotating between Tylenol and Motrin for discomfort, as the child is teething also, and is still giving steroid med. Six days now since immunizations, and the child appears to be doing well. Y Y 01/12/2001 01/12/2001 0 PUB PUB Motrin, Tylenol, Benadryl. NONE Omnicef antibiotics causes slightly raised rash. KS200104 1
0166351 03/02/2001 KS 13.0 13 M 02/07/2001 This child received a Hep B shot in the nurses office at school based clinic. He returned to class and was sitting in the class and fainted. The patient was taken back to the nurses room for observation for 20 minutes. No complications, he was released back to the class. No further problems noted. Y 01/15/2001 01/15/2001 0 PUB PUB KS200110 1
0166352 03/02/2001 KS 15.0 15 F 02/07/2001 The pt experienced chest tightness and shortness of breath. Use Albuterol inhaler 2 times for relief. Shortness of breath and chest tightness continued for awhile but did not seek physicians treatment. Ok the following day. N 01/15/2001 01/15/2001 0 PUB PUB Singulair, Zyrtec NOEN asthma, allergies KS200109 1
0166353 03/02/2001 KS 8.0 8 M 01/26/2001 The pt experienced upper arm redness, warmth to the touch, swollen, painful per pt report after the vaccine was administered. Y 01/24/2001 01/24/2001 0 NONE PUB PUB NONE NONE NONE KS200108 1
0166354 03/02/2001 KS 16.0 16 F 01/23/2001 The pt started itching, had welts all over body, then the face began to swell and she had problems with breathing. Mom and sister took her to the ER. Y Y 11/30/2000 11/30/2000 0 NONE PVT PVT NONE NONE NONE KS200106 1
0166355 03/02/2001 KS 1.0 1 .0 F 01/15/2001 The pt experienced a 1 x 2 cm are of redness with 5cm area of firm edema under injection site. No lymphangitis. No fever. Localized Cellulitis. Y U 01/10/2001 01/12/2001 2 PVT PUB NONE NONE NONE KS200103 1
0166356 03/02/2001 FL 11.0 11 F 03/01/2001 The pt experienced redness, swelling and increased warmth at the site. The pt was seen by her MD and prescribed an antibiotic. The pt used warm alternated with cool intermittent compresses to the site. Y Y 02/22/2001 02/23/2001 1 NONE PVT PUB NONE 1
0166357 03/02/2001 MI 1.0 1 .0 F 03/01/2001 The pt experienced a small blister noted at the site of injection and a small blister on anterior abdominal wall. Y 02/09/2001 02/26/2001 17 PVT PVT NONE rhino sinusitis NONE 1
0166358 03/02/2001 SC 6.0 2 .2 M 02/28/2001 The pt received the vaccines on 7/30/1996 and was then diagnosed with Varicella on 2/23/01. The pt was exposed 10 days prior to eruption. Y Y 07/30/1996 02/23/2001 1669 PVT PVT NONE NONE 1
0166359 03/02/2001 CO 1.08 1 .1 M 02/14/2001 The pt experienced a high fever, cough, maculo-papular full body rash, starting on face and developing distally. Y U 01/29/2001 02/10/2001 12 rapid strep - neg, CBC, RSV - neg PUB PUB NONE NONE NONE 1
0166360 03/02/2001 SD 1.2 1 .1 F The pt experienced a fever, then a rash developed which was non-pruritic. Mostly macular and some slightly papular pink lesions to the trunk and extremities. Rash persists upon exam. N 01/21/2001 02/01/2001 11 NONE MIL MIL NONE NONE 1
0166361 03/02/2001 GA 3.0 3 M 02/19/2001 The child returned one week after vax with a 25 cent piece sized hardened area and with slight bruising evident. U 02/12/2001 02/12/2001 0 NONE PVT PVT NONE NONE NONE 1
0166362 03/02/2001 FL 32.0 32 M 02/21/2001 The pt experienced a headache, myalgia to the neck and malaise. Y 02/20/2001 02/20/2001 0 PUB OTH NONE NONE NONE 1
0166363 03/02/2001 FL 48.0 48 M 02/21/2001 The pt experienced a stiff neck and headache. Y 02/20/2001 02/21/2001 1 NONE PUB OTH NONE NONE NONE FL01006 1
0166364 03/02/2001 FL 33.0 33 M 02/21/2001 The pt experienced a headache, neck stiffness, and malaise. Y 02/20/2001 02/21/2001 1 PUB OTH NONE NONE NONE 1
0166365 03/02/2001 FL 43.0 43 F 02/21/2001 The pt experienced malaise, myalgia and headache. Y 02/20/2001 02/21/2001 1 NONE PUB OTH NONE NONE NONE 1
0166366 03/02/2001 WI 23.0 23 F 02/06/2001 The pt developed a lump at the injection site with redness and tenderness. Now painless but same size. N 12/21/2000 12/24/2000 3 NONE PVT PVT NONE NONE allergy to PCN 1
0166367 03/02/2001 MS 7.0 5 M 02/07/2001 The pt received the vaccines on 4/7/99. Was exposed and contracted chicken pox on 2/7/01. Very mild case. Y 04/07/1999 02/07/2001 672 PVT UNK 1
0166368 03/02/2001 TX 1.0 1 .0 M 02/14/2001 The pt experienced red raised areas, brought to MD's office and diagnosed with urticaria. Y 02/06/2001 02/08/2001 2 PVT PVT Cefzil, Floxin BOM NONE 1
0166369 03/02/2001 TX 1.0 1 .0 F 10 days post vax, the pt came in with red raised papules with central yellow area. Y 11/28/2000 12/08/2000 10 PVT UNK anemia, allergic rhinitis 1
0166370 03/05/2001 GA 72.0 F 02/23/2001 Information received concerning a 72 year old female pt who was vaccinated with a dose of pneumococcal vaccine 14 polyvalent. The pt developed meningitis and subsequently died. The cause of death was meningitis. Y N CSF culture was performed 1 month after vaccination which isolated pneumococci type 15B. OTH OTH UNK Spenectomy WAES01021803 1
0166371 03/05/2001 GA 9.0 M 02/23/2001 Information concerning a 9 year old male pt who was vaccinated with a dose of pneumococcal vaccine 14 polyvalent. The pt developed meningitis and subsequently died. The cause of death was meningitis. Y N CSF culture was performed 6 months after vaccination which isolated pneumococci type 18C. OTH OTH UNK Spenectomy; hemolytic anemia WAES01021804 1
0166372 03/05/2001 GA 62.0 F 02/23/2001 Information concerning a 62 year old female who previously underwent a splenectomy was vaccinated with a dose of pneumococcal vaccine 14 polyvalent. The pt developed meningitis and subsequently died. The cause of death was meningitis. Y N Blood culture-positive isolated pneumococci type 22F; CSF-positive isolated pneumococci type 22F OTH OTH UNK Splenectomy; idiopathic thrombocytopenic purpura WAES01021805 1
0166373 03/05/2001 GA 11.0 M 02/23/2001 Information concerning an 11 year old male pt who was vaccinated with a dose of pneumococcal vaccine 14 polyvalent. The pt developed sepsis and subsequently died. The case of death was sepsis. Y N Blood culture was performed 12 month after vaccination which isolated pneumococci type 22F. OTH OTH UNK Post trauma spenectomy WAES01021806 1
0166374 03/05/2001 KY 0.75 0 .0 F 01/26/2001 Pt had Hep-B shot on 4/29/00 and had 2 seizures on 5/2/00. Sent to another hospital and was put on Phenobarbital for a few months. Is now off of it. Doctors said they did not know why she had the seizures after hearing our medical history. Some have said may have been due to the Hep-B shot and others said they would question this. Was in the hospital from 5/2/00 to 5/4/00. Y Y 2 Y 04/29/2000 05/02/2000 3 MRI completed PUB PVT NONE NONE Hypotonia. Apgar 8/9. 1
0166375 03/05/2001 MS 0.9 0 1 F Pt developed diarrhea and vomiting and a fever of 101F, within 24 hours. Required hospitalization and IV fluids. Y 2 Y 02/05/2001 02/06/2001 1 Stool-neg for rotavirus PVT PVT NONE 1
0166376 03/05/2001 CA 4.0 3 F 02/21/2001 This child had Left thigh erythema, and swelling surrounding the site of injection. Started the evening after receiving vaccination and worsening over the next 2 days. Admitted for cellulitis, and treated with IV antibiotics, then discharged on PO antibiotics to complete 10 day course. Y Y 2 Y 02/16/2001 02/16/2001 0 PVT PUB 1
0166377 03/05/2001 NY 13.0 12 M 02/17/2001 Purpuric spots, low platelet count picture similar to ITP. Y Y Y U 02/01/2001 02/13/2001 12 Platelet count-low PVT UNK 1
0166378 03/05/2001 OH 0.2 0 .2 F 02/15/2001 Immunized 1/30/01, on 2/1/01 and 02/02/01 slept a lot and had a fever of 102F on 02/02/01 with decrease feeds. Admitted to hospital to rule out sepsis. Dx'd with influenza B. In hospital from 2/1/01 to 2/4/01 and went into shock by the time she was admitted to the hospital. Y Y Y 3 Y 01/30/2001 02/01/2001 2 Viral panel (+) influenza type B PVT PVT Tylenol NONE NONE 1
0166379 03/05/2001 IL 1.3 1 .4 F 02/06/2001 Pt is 16 months old and is behind on vaccines. Seen in a clinic within a shelter. Physical exam done then given vaccines in arm. That evening, pt had febrile seizure and was taken to hospital. Y 3 Y 02/05/2001 02/05/2001 0 Some lab tests were done while she was admitted but I don't know results. OTH PUB NONE NONE NONE 1
0166380 03/05/2001 PA 1.25 1 .3 M 02/01/2001 Fever to 103F X 2 days. Simple febrile seizure and irritability. Y Y 1 Y 01/29/2001 01/30/2001 1 CBC with Differential-nml; Electrolytes-nml PVT PVT Zantac Gastroesophageal reflux 1
0166381 03/05/2001 WI 39.0 38 M 01/31/2001 Neck and high back soreness (pain), tightness, grinding, cracking, hot spots. Pain is chronic and extends out through muscles in back and neck. Pain began just days after 1st vaccine and intensified after the 2nd Lymerix on 6/30/00 (same lot #). Treatment: Anti-inflammatories not helping. 60 day follow-up states the pt now has arthritic pain in neck, back, and at the shoulders. Has continual grinding, cracking, etc. Medication does not help. Doc 210785, annual follow up states the following: continued extreme spinal, joint and back pain directly related to vaccines given. Y N 05/30/2000 06/02/2000 3 Lyme Test-neg PUB PVT NONE 1
0166382 03/05/2001 NJ 60.0 60 M 01/30/2001 Arthritis in hands, feet and ankles. (Had second Lymerix on 5/7/99) Y N 04/05/1999 04/17/1999 12 ANA titer-1.8; Rheumatoid Factor-125; (Lyme test) Burgdorferi; .32 PVT PVT NONE NONE Athritis~Lyme (LYMErix)~2~60.00~In Patient 1
0166383 03/05/2001 PA 64.0 62 M 02/22/2001 This patient had joint pain. Y Y 07/02/1999 10/01/1999 91 PVT PVT NONE NONE Arthritis 1
0166384 03/05/2001 CT 40.0 F 02/27/2001 A pharmacist reported that a 40 year old female received an IM injection of Flu Shield on 02/20/01. The patient was noted to have "Flu symptoms" at the time of the vaccination. Two days following vaccination, on 02/22/01, the patient was admitted to an ICU in an unconscious state. The reporter thought that the patient was intubated and she was unarousable. She was treated with Acyclovir and unspecified antibiotics. Y U 02/20/2001 02/22/2001 2 UNK PVT OTH Oseltamivir, vitamins NOS Flu symptoms UNK HQ7683026FEB2001 1
0166385 03/05/2001 1.25 1 .2 M 02/27/2001 Information has been received from an investigator concerning a 15 month old who received vaccines on 9/2/00 as part of a post-marketing safety surveillance trial. On 9/25/00, he presented for otitis media where the physician noted that the subject had possible bruising on the chest. The physician speculated that this may have been secondary to trauma. On 9/29/00, he had more bruising and was brought in by his parents. He was hospitalized and treated with IV immune globulin. He was discharged on 10/2/00. The next day, he was seen and his platelet count was 295,000 cells/mm3. Both the investigator and the medical monitor agree that idiopathic thrombocytopenic purpura (not expected) was 'possibly related' to either Prevnar or other vaccines administered. Y 4 Y 09/02/2000 09/25/2000 23 Platelet count-5,000 cells/mm3 on 9/29/00; platelet count 13,000 cells/mm3 on 9/20/00; platelet count was 103,000 cells/mm3 on 10/2/00 at discharge. On 10/3/00, platelet count-295,000 cells/mm3. UNK UNK UNK UNK HQ7622224FEB2001 1
0166388 03/05/2001 MI 0.2 0 .1 M 11/26/2001 The pt's grandmother reported that a 2 month old male pt received vaccines on 10/23/00. Reportedly, the next day, the pt developed continuous crying, seen in physician's office. The pt was hospitalized on 11/22/00 due to respiratory failure, bruising around the mouth, petechia and swollen tongue. Pt was discharged on 12/20/00 with a dx of Shaken Baby Syndrome with brain damage, blind and deaf. Pt is on feeding tube and Phenobarbital for seizures. No further info is available. Upon internal review, seizures were considered an other medical event. this is an amended report. The pt's age has been changed to 7 wks old. This is corrected report as amended. Mailed follow-up correspondence received on 06/12/2001 stated: the vaccine administered physician did not report this adverse event. F/U mail follow up correspondence rec'd from (WAES01061938) on 7/9/01 specified that the Hepatitis B vaccine given to the patient was Recombivax HB. F/U other business numbers include F200100677,F2001006771 and U200100437. F/U faxed correspondence received on 9/4/01 reports, "This is an amended report. The pt's age has been changed from a 12 to a 7 week old". F/U info rec'd on 11/26/01 from a physician indicated that this was not a reaction to vaccine and that it was whaken baby syndrome as previously reported. The physician noted that he did not report the event as a possible vaccine reaction. No further information was available because the physician was not at the practice where the child was seen. The physician felt that continous crying, respiratory failure, bruising around mouth, petechiae, swollen tongue, brain damage, blind, deaf and seizures were not related to the therapy with hepatitis B vaccine. Upon internal review, seizures were considered to be an other important medical event. From faxed correspondence received on 09/04/2001 states that "this is an amended report. The pt's age has been changed from a 12 to a 7 week old. From follow-up correspondence received on 11/26/2001 it was reported,"This was not a reaction to vaccine, it was Shaken Baby syndrome as I previously reported. I did not report it as a possible vaccine reaction. I do not have any other information, as I'm not at the practice where this child was seen." The pt's grandmother was the initial reporter per the physician. Y Y 28 Y N 10/23/2000 10/24/2000 1 OTH OTH Antibiotics Respiratory infection on antibiotics 5 weeks premature; respiratory infection, on antibiotics U200100437 1
0166389 03/05/2001 NJ 47.0 46 F Report received 2/13/00, from a physician, regarding adverse events possibly associated with Fluvirin. A 47 year old female pt received the vaccination at the end of October, 2000 and within 2 weeks, she developed severe arthritic symptoms; took ibuprofen, with relief; stopped the ibuprofen and relapsed. In mid-December, she developed ascending numbness, from feet to neckline and the sensation of "stocking/glove"; not complete loss of sensation. On 1/01/01, she noticed electrical-shocking spasms. She has been prescribed a 21 day course of Ceftin for Lyme Disease-like symptoms; is also being treated with Pamelor some compound (carisoprodol and aspirin preparation), and Motrin. The pt had received her 3rd and final dose of Lymerix vaccine in June of 2000. The reporting MD questions interaction between Lymerix and Fluvirin or the possibly that Fluvirin stimulated on autoimmune reaction to trigger Lyme-like reaction. Additional information has been requested. N 10/01/2000 01/01/2001 92 CT Scan of lumbosacral spine; MRI of brain and cervical spine; EMG; Spinal Tap and Blood work, done in mid-December to mid-January-all wnl. UNK UNK NONE June 2000, Respiratory infection MPI2001002360 1
0166390 03/05/2001 NC 1.25 1 .3 M 02/27/2001 The pt experienced respiratory distress and fever. Onset from 8-12 hours post vax. The pt was hospitalized for 24 hours. Treated with albuterol. Diagnosed with Viral Respiratory Infection with RAD Y 1 Y 02/19/2001 02/19/2001 0 RR 75, P 190, 02 Sat 94%, Temp 103, CXR, CBC - wnl, RSV - neg PVT UNK Rhinitis Passive smoker 1
0166392 03/05/2001 AZ 42.0 42 F 01/31/2001 On 01/03/01, this patient developed hives approximately 6 PM, tightness in the upper chest, and difficulty breathing. The patient saw the doctor on 01/04/2001, said his lungs "sounded like a 70 year old smoker" in stead of a 42 year old non-smoker. Given breathing treatment on 01/04/01 and 01/05/01. Medications: Prednisone, Combivent inhaler, Atarax, and Zantac. Y Y Y 01/03/2001 01/03/2001 0 PVT PVT Drug allergy to Zithromax, Adriamycin; Medical: MVP 1
0166393 03/05/2001 TN 1.25 1 .3 F 01/29/2001 Seizure activity: stopped breathing and was given CPR by mother until EMS arrived. Transported to hospital for evaluation and admitted for observation. Diagnosis includes probable encephalopathy secondary to DTaP, Metabolic Acidosis, Dermatitis Y Y 1 Y 01/25/2001 01/26/2001 1 CT Scan; Chem 8, CBS, CXR PVT PVT URI Seasonal allergies; chronic OM 1
0166394 03/05/2001 OH 4.0 4 M 01/25/2001 Pt with fever, dx'd with acute demyelinating encephalomyelitis. Follow up on 04/21/2001: "Patient is at home getting physical therapy and is re-cooperating. On 12/01, patient had MMR vaccination. A few days later, patient started vomiting which eventually lead to severe headaches and fever. On 12/16, patient had a CT scan of the head and was found to have a sinus infection, although he had no symptoms of a cold. Patient was being treated at home with oral antibiotics. On 12/19, he woke up with slurred speech, left sided facial droop and left sided weakness. patient was taken to the ER where IV antibiotics were started bacause of the suspicion on meningitis. Patient was transferred and weakness subsided by that evening an an acutal spinal tap and MRI were not done until the latter part of the night. The MRI and EEG were normal but there were white cells found in his spinal fluid. At this point, MD's did not feel that he had full blown meningitis, but that his meninges were just beceoming irritated. Patient's sinuses were drained surgically on 12/23 and they could not believe all the puss and fluid that was found in a little boy that didn't have any cold or upper respiratory symtpoms. Patient also had a repeat spinal tap which showed lessening of the white cells. Patient did start to do a little better after his sinus surgery and sent home on 12/27 on IV antibiotics to finish out his full 10 days of therapy. On 12/29, patient was re-admitted because of headache and fevers. His white count was 40,0000 and sed-rate was 100,000 which is a sign of infection. Another MRI was repeated which was normal, although told abnormal in the beginning, but the questionable area got read as artifact movement. A repeat spinal tap was done which was mildly elevated. Patient went through another sinus sugery which did not show much infection. At this point, they did not feel his sinuses were the root of his infection and that patient he checked out more throughly. Patient had a bone scan, CT of the abdomen and pelvis, echocardiogram and lots of blood work. Everything came back normal except elevated white counts and sed rate. At this point, the doctors began thinking maybe he was having drug fevers from his antibiotics or he had an underlying condition such as rheumatoid arthritis. He was seen by a rheumatologist who did take patients MMR immunization more seriously than anyone else would even listen to. He said: " Maybe that MMR shot put those white cells in patients spinal fluid", but then dismissed it. He wanted to see if patient off of the antibiotics because people can have adverse reactions and they may have been clouding patients picture. Patient had finished his new regiment of antiobiotics (14 days after his first sinus surgery) and because maybe it was drug fever, we could now go home again. We were told that patient was not going home with any life threatening condition. Discharged for a second time on 01/07. That night, we called his doctor and said that patient was walking like he was crippled. Patient could hardly go up the steps, get on the couch, or walk for that matter. Patient again began having fevers and was having very odd talking in his sleep. He was screaming out about every half our in his sleep. Saying very odd, lethargic-like stuff. 01/10, saw the rheumatologist again. He was concerned about patient sleeping more and didn't feel that patient was exhibiting rheumatological symptoms, but was exhibiting more neurological symptoms. He called our neurologist and got back in the picture. The neurologist saw us on 01/11 and had to talk us into going back to the hospital. She wanted another MRI and EEG. After finding out that his white count and sed-rate were still rather elevated we agreed to go back to the hospital for a third time. On 01/11/2001, patient was admitted for a 3rd time. A repeat MRI of the brain and spine was now very abnormal. He had inflammation of the brain, spine and swelling of his brainstem. This was diagnosed as Acute Disseminated Encephalomyelitis. At this point on 01/12, steroids were started so that patient could be watched a bit more closely. After 48 hours of the steroid therapy, we were sent back up to the 6th floor. Patient could walk much better. He remained on the IV for 5 days and then gradually tapered to oral steroids for about 12 days. Discharged on 01/19. Patient began having headaches, weakness and tremors because of being tapered off the steroid. He has been put back on the steroid and it has helped. Patient attends physical and occupational therapy. Patient still has a slight tremor of his hands and some weakness in his legs." Y Y 21 Y Y 12/01/2000 12/10/2000 9 LP-(+) increased protein, pleocytosis; MRI-White matter cortical, brainstem, spinal disease PVT PVT Motrin allergy 1
0166395 03/05/2001 VA 0.2 0 .2 M 02/11/2001 He was limp, unresponsive (as if he wasn't there) when you waved your hands in front of his open eyes. He also kept startling at the slightest noise. Seizure type reaction; duration at least 1/2 hour. Was later dx'd with "Autistic Encephalopathy". Y N 05/09/1994 05/09/1994 0 MRI - Neg, Genetic Screening - Neg. (Later diagnosed with "autistic encephalopathy"). PVT PVT NONE NONE NONE 1
0166396 03/05/2001 1.4 1 .4 M 02/27/2001 A physician reported that a 17 month old male received his 2nd injection of Prevnar on 9/25/00. One day, post vax, the child was seen in the clinic after developing angioedema and urticaria. The child recovered. Both the investigator and the medical monitor considered the events to be "possibly" related to Prevnar administration. Y 09/25/2000 09/26/2000 1 NONE UNK UNK UNK UNK HQ7613423FEB2001 1
0166397 03/05/2001 1.25 1 .2 F 02/27/2001 A physician reported that a 14 month old female received her 2nd injection of Prevnar on 11/10/00. One day, post vax, the child was seen in the clinic after developing angioedema and urticaria. The child recovered. Angioedema was considered to be "Medically Important". Both the investigator and the medical monitor considered the events to be "possibly" related to Prevnar administration. Follow up information received 03/09/2001 clarified that the patient did not experience angioedema as originally reported. The patient experienced hives/urticaria only. Therefore, this report has been downgraded to non-serious. Y 11/10/2000 11/11/2000 1 NONE UNK UNK UNK UNK HQ7613223FEB2001 1
0166398 03/05/2001 1.4 1 .4 M 02/27/2001 Information has been received from an investigator concerning a 17 month old male child who received Prevnar on 12/8/00. The next day, post vax, the child was taken to a local clinic with urticaria and angioedema. The child has since recovered. Angioedema was considered a "Medically Important Event". Both the investigator and the medical monitor agree that this event was 'possibly' related to vaccine administration. Follow up information was received on 03/09/2001 that clarified that the patient did not experience angioedema as originally reported. the patient experienced hives/urticaria only. Therefore, this report has been downgraded to non-serious. Y 12/08/2000 12/09/2000 1 NONE UNK UNK UNK UNK HQ7610123FEB2001 1
0166399 03/05/2001 1.0 1 .0 M 02/26/2001 A physician reported that a 12 month old male received his 2nd Prevnar on 9/27/00. Two days, post vax, the child was seen in the clinic after developing angioedema and hives/urticaria. The child recovered. Both the investigator and the medical monitor considered the events to be 'possibly' related to Prevnar administration. Follow up information received 03/09/2001 clarified that the patient did not experience angioedema as originally reported. The patient experienced hives/urticaria only. Therefore, this report has been downgraded to non-serious. Y Y 09/27/2000 09/29/2000 2 NONE UNK UNK UNK UNK HQ7614223FEB2001 1
0166400 03/05/2001 1.08 1 .1 F 02/26/2001 A physician reported that a 13 month old female received her 2nd Prevnar and the next day, experienced angioedema and hives/urticaria. The child recovered. Angioedema was considered to be "Medically Important". Both the investigator and the medical monitor considered the events to be 'possibly' related to Prevnar administration. Follow up information received 03/09/2001 clarified that the patient did not experience angioedema as originally reported. The patient experienced hives/urticaria only. Therefore, this report has been downgraded to non-serious. Y 09/07/2000 09/08/2000 1 NONE UNK UNK UNK UNK HQ7612923FEB2001 1
0166401 03/05/2001 1.0 0 1 M 02/26/2001 Information has been received from an investigator concerning a 12 month old male child who received Prevnar on 9/26/00 and on the next day, the child was taken to a local clinic for urticaria and angioedema. The child has since recovered. Angioedema was considered a "Medically Important Event". Both the investigator and the medical monitor agree that this event was 'possibly' related to vaccine administration. Follow up information received on 03/09/2001 clarified that the patient did not experience angioedema as previously reported. The patient experienced urticaria only. Therefore, this report has been downgraded to non-serious. Y Y 09/26/2000 09/27/2000 1 NONE UNK UNK UNK UNK HQ7609823FEB2001 1
0166402 03/05/2001 2.0 2 .2 F 02/26/2001 Information has been received from an investigator concerning a 26 month old female child who received Prevnar on 8/25/00 and the next day, the child was taken to a local clinic for urticaria and angioedema. The child has since recovered. Angioedema was considered a "Medically Important Event". Both the investigator and the medical monitor agree that this event was 'possibly' related to vaccine administration. Follow up information received 03/09/2001 clarified that the patient did not experience angioedema as previously reported. The patient experienced urticaria only. Therefore, this report has been downgraded to non-serious. Y Y 08/25/2000 08/26/2000 1 UNK UNK UNK UNK UNK HQ7609623FEB2001 1
0166403 03/05/2001 1.08 1 .1 F 05/01/2000 Information has been received from an investigator concerning a 13 month old female child who received Prevnar on 5/1/00 and later that day, the child was taken to a local clinic for urticaria and angioedema. The child has since recovered. Angioedema was considered a "Medically Important Event". Both the investigator and the medical monitor agree that this event was 'possibly' related to vaccine administration. Y Y 05/01/2000 05/01/2000 0 NONE UNK UNK UNK UNK HQ7609423FEB2001 1
0166404 03/05/2001 0.7 0 .9 F 02/27/2001 Information has been received from an investigator concerning a 10 month old female child who received Prevnar on 12/22/00 and the next day, the child was taken to a clinic for urticaria and angioedema. The child has since recovered. Angioedema was considered a "Medically Important Event". Both the investigator and the medical monitor agree this event was 'possibly' related to vaccine administration. Follow up information received on 03/09/2001 clarified that the patient did not experience angioedema as previously reported. The patient experienced urticaria only. Therefore, the report has been downgraded to non-serious. Y Y 12/22/2000 12/23/2000 1 NONE UNK UNK UNK UNK HQ7618423FEB2001 1
0166405 03/05/2001 CA 1.2 M 02/27/2001 A physician reported that a 14 month old male received his 2nd Prevnar on 9/12/00 and the next day, the child developed urticaria and angioedema. He was seen in a clinic and recovered. Angioedema is considered "Medically Important". Both the investigator and the medical monitor agree that the events are possibly related to vaccine administration. Follow up info received on 3/9/01 clarified that the pt did not experience angioedema as previously reported, he experienced urticaria only. Therefore, this report has been downgraded to "non-serious." Y Y 09/12/2000 09/13/2000 1 NONE OTH OTH UNK UNK UNK HQ7612423FEB2001 1
0166406 03/05/2001 1.75 1 .8 M 02/27/2001 Information has been received from an investigator concerning a 21 month old male child who received his 1st dose of Prevnar on 12/8/00 and later that day, the child was taken to a local ER with urticaria and angioedema. The child has since recovered. Angioedema was considered a "Medically Important Event". Both the investigator and the medical monitor agree that these events were 'probably' related to vaccine administration. Follow up information received on 03/09/2001 clarified that the patient did not experience angioedema as previously reported. The patient experienced urticaria only. Therefore, this report has been downgraded to non-serious. Y Y 12/08/2000 12/08/2000 0 NONE UNK UNK UNK UNK HQ7626124FEB2001 1
0166407 03/05/2001 CT 33.0 M 02/15/2001 The pt received his 1st Lymerix injection on 1/24/01. Immediately, post vax, he became light-headed and dizzy and experienced blurred vision. He recovered "within moments", without treatment. The reporter stated that "it sounded like" the pt "had a problem with needles." Y 01/24/2001 01/24/2001 0 OTH OTH 20010043221 1
0166408 03/05/2001 NJ 63.0 61 F 02/26/2001 On 5/9/99 and 6/9/99, the pt received her 1st and 2nd Lymerix doses, respectively. Thirty-three days after dose #2 of Lymerix, the vaccinee was dx'd with Bell's Palsy. She was treated with prednisone from 7/12/00 to 7/16/00. Lymerix was not discontinued, but the schedule was interrupted. As of 2/22/01, the outcome of the event is unknown. There was no illness at the time of vaccination. As of March 14 2001, the outcome of the event was resolved. The reporter stated that the adverse event of Bell's palsy was moderate in intensity and was possibly related to Lymerix. The reporter stated that the adverse event of Bell's palsy was disabling incapacitating. Follow up 02/26/2002: "On 02/11/2002, in a Statement of Injuries, the vaccinee's attorney alleged that the vaccinee "suffers from pain and swelling in her joints, in particular in her hand. She also experiences fatigue. In addition, she suffers from Bell's Palsy." Treatment and outcome of the joint pain, joint swelling, and fatigue were not provided. According the vaccine provider, the Bells Palsy had resolved by 03/14/2002." The follow up received on 3/13/02 states the medical history included allergies to aspirin, penicillin, erythromycin, pantazocine and propoxyphene. The medical history also included non-insulin dependent, fatigue (Sept 1992), headache, calcification in the right carotid artery, and cervical sprain and shoulder contusion following a motor vehicle accident (5/23/97). Surgical history included hysterectomy and an unspecified "gallbladder operation." Following the reported onset of Bell's palsy, the vaccinee experienced gastroenteritis with hypolakemia and dehydration that required hospitalization. These were not reported as adverse events due to vaccine administration, but were found during the course of review of the vaccinee's medical review of the vaccinee's medical records. Therefore, they are not listed as adverse events. 13 months after the second LYMErix injection, the vaccinee presented to the local ER with watering of the left eye, left facial paresis, and pain in the right frontal andleft temporal areas. The vaccinee reported that the symptoms began on 7/9/00. On examination, the emergency room physician noted left facial droop and ptosis. Lyme ELISA was psotiive, Lyme IgG and IgM western blot were negative. The physician made a diagnosis of Bell's palsy. The most recent info received on 3/13/02, did nto provide the outcomes of the reported events. The follow up receive on 6/25/02 states that the vaccinee experienced a urinary tract infection, migraines, hypercholesteremia. On 7/12/00, the pt was seen by her physician who wrote, "obvious Bell's palsy noted ot the left side of the face, pt unable to close her eye voluntarily unable to smile on the left side of the face, there is decreased sensation, ears neg, throat shows no lesions, upper body strength is normal. On 7/19/00, her physician sent hte pt a prescription for tetracycline 500mg with a note stating: "Enclosed is a prescription to take for 3 weeks. This will cure the "Lyme" and the Bell's palsy should resolve." The most recent info received on 6/25/02, did not provide the outcomes of the other reported events. Y Y Y 06/09/1999 07/09/2000 396 Lyme Elisa titer on 7/10/00-positive. Lyme IgG western blot negative, IgM western blot negative 7/10/00 PVT PVT Estrace, Synthroid Diabetes; Hypothyroidism 20010049081 1
0166409 03/05/2001 CO 1.25 3 F 02/01/2001 On 1/25/01 at 20:00, the site of injection was red and swollen and warm to the touch. The redness is 2 1/2" wide and 3" in length. On 1/26/01, doctor's office visit and leg was still swollen and red. Area was the same size as stated above. Y 01/24/2001 01/25/2001 1 PVT UNK NONE NONE 1
0166410 03/05/2001 FL 1.25 1 .3 F 02/01/2001 Erythematous rash with mild induration of left mid-anterior thigh. 1st noted about 24 hours, post vax. Y 01/29/2001 01/30/2001 1 NONE PVT PVT NONE NONE 1
0166411 03/05/2001 FL 3.0 3 F 01/30/2001 Edema, erythema and induration. Y 01/24/2001 01/24/2001 0 NONE OTH PUB NONE NONE NONE 1
0166412 03/05/2001 NY 39.0 39 F 02/08/2001 Multiple arthritic symptoms; joint pain and swelling (joint will get hot and red), both shoulders, neck, lower back pain, blurry vision in both eyes and headaches. The follow up received on 2/11/02 states joint pain in a 39 year old female who received Lyme disease vaccine recombinant OspA (LYMErix). This report was received from the pt, who initially reported that she was a participant in a clinical trial. However, medical records confirmed that hse received the vaccine post-marketing. Additional info was received as part of litigation proceedings, with forwarding of medical records. Medical history included allergies to codeine and penicillin, tobacco use, bronchitis, emphysema, noninsulin dependent diabetes mellitus, "low blood sugar," "lazy right eye," blind spots, blurry vision, ocular migraines, hemorrhoids, fracture of the fourth right metatarsal, depression, anxiety, warts, and otitis media. THere was no personal or family history of gout, psoriasis, Crohn's disease, rhuematoid arthritis, or lupus erythematosus. The pt underwent x-ray of the right wrist with special attention to the scaphoid on 9/6/91, for an unspecified reason; the results were interpreted as "normal study." The pt underwent x-ray and three-phase bone scan of both hands and wrist, with special emphasis on the scaphoid, on 1/28/92 for an unspecified reason, the results were interpreted as "normal study." Family history was significant for diabetes mellitus and glaucoma in the pt's father; he was blind prior to his death. The pt had no history of Lyme disease. On 3/11/99, she presented to her primary physician "with multiple complaitns. Specifically she would like to get checked for Lyme's disease. She brings a three page letter describing her symptms. Essentially about four months ago she had a potential tick on her finger which she pulled off. She states that a few days after this she developed an itchy red rash on her turnk and her neck which looked like hives. She also had some associated swelling in the lips. She described off and on flu-like symptoms over the past three months. She's had various joint aches and pains most notable in the shoulders, the knees and the hops." Erythrocyte sed rate, ANA titer, and rheumatoid factor were measured on 3/11/99; the reuslts were negative. Total Lyme antibodies measured by ELA on 3/11/99 were reported as seronegative. The physician wrote, "I discussed with her briefly consideration of this being depression and considering a trial of an antidepressent." Antidepressent therapy was initiated on 3/25/99. Concurrent medications included Vioxx, Celebrex, Motrin, Zoloft and Lasix. The pt initially reported that hse received her first injection of LYMErix in the fall of 1998 and the second dose one month following the first. She reported to manufacturer that she had no adverse experiences following receipt of the first two injections. Review of medical records indicated that the first dose of LYMErix was injected into the right arm on 5/20/99, and the second dose of LYMErix was injected into the left arm on 6/28/99. The pt would later rpeort to a physician that joint pain began after the first injection of LYMErix. The pt received her third dose of LYMErix, injected into the left arm, on 7/28/99. The third dose was adminsitered two months, rather than the recommended interval of 12 months, following the administration of the first dose. The pt initially reported that approximately one month following the third injection, she developed right elbow edema, redness, pain and heat. She also reportedly developed bilateral ankle edema; no redness or heat was noted in the ankles. She stated that she experienced cervical pain at times. She reported that she experienced joint pain in both shoulders; the pain was worse in the right shoulder. The right shoulder pain continued to worsen over the next two years. The pt reported that she had not been seen by a physician at the time of "flare ups," but planned to be evaluated by an orthopedic surgeon. On 2/11/02, in a statement of injuries, the pt's attorney alleged that the pt "suffers from multiple joint pain, most prominently in the shoulder joints, as well as sensitivity to light and blurred vision." The following information was obtained from medical records. The pt's right shoulder was x-rayed on 8/18/99; the indication for the x-ray was "right shoulder pain." The radiologist's impression was "negative exam." The pt went to the local ER on 6/14/00, after falling and hitting her elbow on a concrete wall. She reported that her elbow was warm and swollen, and that she experienced pain in the elbow and a burning sensation in the arm. Medications at that time included sertraline and ibuprofen 800mg as needed; the pt did not report the indication for ibuprofen therapy. An x-ray of the elbow revealed that "chronic enthesopathy is present, but no acute fracture." A diagnosis of soft tissue injury was made. The elbow was wrapped in an bandage, and the arm was placed in a sling. The pt was sent home. The pt presented to a ophthalmologist on 10/26/00 with complaints of "Trouble with blurry vision, left eye seems to at times have blind spot in bottom of eye. Sometimes sees halo around light." She reported that she wore corrective eye lenses since the age of 2 years. She also reported that her father had diabetes mellitus and glaucoma, and that he was blind prior to his death. She reported a history of ocular migraines that were relieved with ibuprofen. She reported seeing "blank spot" occasionally while driving and when having a migraine. Visual acuity with corrective lenses was 20/20 in each eye. discs-right 0.35, shallow cupping; left 0.2-0.25. Pressures were right 19, left 17. The ophthalmologist urged the pt to see a specialist "at her earliest time." On the referral slip, the ophthalmologist indicated a diagnosis of glaucoma. When seen again on 11/9/00, pressure were right 23, left 17. On 6/7/01, the pt returned to the ophthalmologist complaining of sore eyes. The ophthalmologist noted dry eyes and prescribed "Genteal gel." The opthalmologist again recommended that the pt see a specialist to "check optic nerve changes and autoimmune changes?" The pt did not make an appointment to see this specialist until 2/20/02. The pt came under the care of a new primary physician. She presented to this physician on 11/15/00 with a complaint of "right shoulder pain which she has been having for at least the past year. She says it is a heaviness which she feels only as she starts slowing down at night with limitations even adduction of the right shoulder without concomitant swelling or effusion. It usually responds to Motrin taken every eight hours. No active complaints." On physical examination, the physician noted "point tenderness on trapezius area of right shoulder but no limitation of movement of the shoulder. No effusion, crepitation, swelling or erythema of the shoulder." The physician's assessment was "right shoulder pain. Rule out degenerative process. She however says this is very responsive to Motrin taken as needed and she thinks that when she takes Motrin at night she doesn't wake up in the morning with any stiffness of the shoulder." She was advised to continue Motrin therapy and and to begin active exercieses of the right shoulder. The pt's now primary physician referred her to another ophthalmologist on 12/29/00 to rule out glaucoma.At that time, the pt reported burning, redness, epiphora, and foreign body sensation. She reported a history of migraines, moninsulin dependent diabetes mellitus for the past five to six years. "Blind spot when b.s. (blood sugar) is low," "lazy right eye," anxiety, and depression. She reported her occupation as "housewife." Medications included sertraline and ibuprofen. The ophthalmologist's impression was borderline glaucoma "with cupping" and blepharitis. The pt presented to her primary physician on 2/5/01, "complaining of multiple joint pains; mainly the neck, bilateral shoulder, low back, ankles and knees. She is trying to associate this after she was given LYMErix some time in May 1999. Since then she has been having symptoms of the above, especially right after the infection. Pt states she does quite a lot of lifting at home. She denies any recent trauma tto the affected areas that she mentioned. Denies ever complaining about it before the LYMErix injection. She denies any fever, chills. No hisotry of rheumatoid arthritis. No other associated problems." Physical examination revealed "Bilateral shoulder discomfort on palpation of bicipital tendon groove but no obvious swelling or erythema. Also has palpable complaints of tenderness on lumbosacral area. Gait normal. No obvious swellings in all joints in the lower extremities mainly the knees and nakles." The physician's assessment was "multiple sites of arthralgia." The physician continue Vioxx anti-inflammatory therapy. ESR, ANA titer and rheumatoid factor were negative. On 2/6/01, "The HLA DR region was typed and the following alleles were found: DRB1 1302 (DR6), DRB1 0101 (DR1)." The pt underwent MRI of the left shoulder on 3/29/01. The radiologist's impressions were "some increased signal identified in the supraspinetus tendon, compatible with partial tear or strain. Impingement of the supraspinstus at the level of the AC joint." The pt was referred to a specialist for evaluation of joint pain on 3/14/01. The pt presented to this physician "with many complaints. The pt's biggest complaint is her lower back pain and left shoulder pain and neck pain. The pt states approximately two years ago she had the Lyme disease vaccination. The pt's symptoms started approximately one week after her injection into her left shoulder of the vaccination. The pt states that she had severe left shoulder pain that progressively went into the right shoulder after she had her second injection. The pt states before this vaccination she had no pain at all. The pt denies any past injuries to her shoulder. The pt has significant complaints of multiple joint pains, redness, swelling and mentally irritable as well as rashes sporadically. There is an entire list of symptoms that the pt has had over the last two years; however, the pt comes today for her bone and joint pain that is excessively worse in the left shoulder. The pt states that she feels that it is a deep aching." Medications at the time of evaluation included sertraline and ibuprofen. On examination of the left shoulder, "Palpation of the anatomic landmark is tender. The AC joint and the SC joint are painful on stress. Palpation ofhte paravertebral muscles is slightly tender. ROM of the shoulder is limited actively by the pain, passively ROM is complete with exception of Yergason, Speed, Wright, and apprehension test are negative. Examination of hte cervical spine: The pt does not present any antalgic position of hte neck. THere is no scoliosis or kyphosis. Palpation of hte para-vertebral muscles elicite pain. Palpation of the spinous process is tender. Stimulation of the Greater Occpital nerve at the base of the skull is tender. Trapezius and Scalenius muscles are tender on palpation. The pain limits the ROM actively. On passive motion, flexion and extension are incomplete. The right and left rotation is possible at 100%. The right and left lateral flexion is possible also at 100%. Neurological examination of the upper extremities shows no abnormality and symmetrical reflexes without any sensory deficit. Spurling test is negative on both sides without pain radiating in the forearm. There is no sign of upper motor neuron lesion or sign of any particular nerve root compression in the cervical spine. There is no sign of thoracic outlet syndrome. Wright test is negative. Neurological evaluation of the lower extremities is also normal. Examination of the shoulder girdles is normal. Examination of hte elbows. The epicondyl is asymptomatic. Neurological examination is normal. There is no abnormal swelling. Palpation ofthe anatomic landmarks is pain free. The lateral ward is pain free. Muscle strength is normal around the elbow. The ROM is complete. No radial nerve entrapment syndrome. There is no motor or sensory ulna nerve anomaly. Resisted extension of the wrist and the extensors of the finger is not painful." The following was recorded as the diagnosis: "The subjective and objective evaluation of this pt is in favor of multiple joint pains, etiology unknown at this time." Under plan of treatment, the physician wrote, "There is a possibility that she may have some sort of internal derangement of the left shoulder. The pt was given some samples of Mobic. The pt denied having physical therapy due to the expense of it. Her blood work that was perfomred was reviewed and was all within normal limits. I believe at this time that hte pt should be referred to a rheumatologist and the rheumatologist will be able to identify where her multiple joint pain is coming from, most likely a form of a rheumatoid like arthritis. There is a minimal chance that this could be associated with the Lyme disease vaccination." The pt was seen again by the specialist on 4/11/01 for "follow up of the complaint of a painful right shoulder that she claimed to be related to a Lyme vaccination. At close examination of this pt, this pain looks purely mechanic and not related to a systemic disease. It is coming from the AC joint of the right shoulder. A diagnosis of impingement syndrome has been made and an investigation has been done accordingly. The impingement test confirmed a diagnosis of impingement of syndrome." Upon examination of the right shoulder, "The clinical picture of this pt did not change since the last visit. The injection of the AC joint done confirmed the origin of the pain. There is no deterioration and no aggravation fo this arthritis. Palpation of the anatomic landmark is tender over the humeral head. The AC joint and the SC joint are not painful on stress. Palpation of hte paravertebral muscles is slightly tender. The painlimits ROM of the shoulder activity. Passive ROM is complete. Yargason, Speed, Wright and apprehension test are positive. There is a painful click at 70 degree of flexion and abduction. Injection test performed is positive for impingement syndrome of the AC joint." Diagnosis was recorded as "Mechanical impingement syndrome seconary to AC joint degeneration." Under plan of treatment, the physician wrote, "I do not see any relation to any vaccination problem. If there is a problem with Lyme disease, this painful shoulder is not related to it. I suggest acrominoplasty of the AC joint." X-ray of shoulders revealed "Degenerative changes of the left AC joint. Otherwise, unremarkable bilateral shoulders." The pt returned to the second ophthalmologist on 4/26/01. At that time, she reported "joint disease secondary to LYMErix vaccination." Medications at that time included ibuprofen. Blepharitis with lash crusting was observed. The ophthalmologist's impression was borderline glaucoma "with cupping." The pt saw the specialist on 5/21/01. "The subjective complaints are unchanged for the shoulder as well as for the orthopedic complaints." The diagnosis remained "Mechanical impingement syndrome secondary to AC joint degeneration." Following the reported onset of joint pain, the pt experienced chronic right otitis media, otitis externa, recurrent sinusitis, tooth abscess, enlarged lymph nodes in the breast, impacted cerumen, heartburn, temporomandibular joint dysfunction, allergic reaction to Augmentin, felon of hte third finger of the left hand, glaucoma, dry eyes, and blepharitis. These events were not reported as adverse events due to vaccine administration but were found during the course of review of the pt's medical records. Therefore, they are not listed as adverse events. The most recent info received 7/25/02,did not provide outcomes of the reported events. Follow up on 03/26/2001: "1st correction: Dates of vaccine are 05/20/1999, 06/28/1999, 07/28/1999 all same Lot #: LY123A6; 2nd correction: My age at time of vaccination was 39; 3rd correction: 1st adverse event was after 1st shot 05/20/1999, right arm injection site and right shoulder pain. Actually reported to RN administering 2nd shot (06/28/1999) of extreme pain in right shoulder and injection site." Y N 05/20/1999 05/20/1999 0 Antinuclear antibody negative; erythrocyte sed rate 16mm/hr, 13mm/hr; rheumatoid factor negative; total Lyme antibodies EIA seronegative; x-ray right shoulder negative. PVT PVT NONE 1
0166413 03/05/2001 SC 1.5 1 .5 M 02/13/2001 Pt had fever of 104.6F, 3-4 hours, post vax. Y 02/13/2001 02/13/2001 0 PVT PUB 1
0166414 03/05/2001 CA 0.3 0 .4 M 02/14/2001 Had swelling of eyes, tearing and sneezing for 3 hours, post vax. Was seen ER and sent home. Follow-up done on 2/12/01. Was given Benadryl in ER. Y Y 02/09/2001 02/09/2001 0 NONE MIL MIL Lotrimin cream, HC 1% cream Dermatitis NONE 1
0166415 03/05/2001 NJ 3.0 3 M 02/05/2001 Was fine the day of the IZ, but became extremely active "could not sit still". He was running from room to room, unable to calm himself from the next afternoon at about 13:30 until about 20:00. He fell asleep at that time and woke up fine. Mother had felt that she had to almost restrain him, so he would not hurt himself. Y 01/31/2001 02/01/2001 1 PVT PVT NONE NONE NONE 1
0166416 03/05/2001 KY 1.4 1 .4 M 02/05/2001 This pt had a "spell", possibly a seizure. Child received Prevnar at 10:00 on 1/30/01. Around 17:00, suddenly became limp, while eating. Mom thinks he passed out for 1 minute. No abnormal movements. 2nd episode about 19:00, eyes rolled back, passed out for several minutes. Brought to ER, immediately. Regain consciousness but was dazed and lethargic X 2 hours. That night started low-grade fevers. Y Y 01/30/2001 01/30/2001 0 EEG PVT PUB NONE NONE 1
0166417 03/05/2001 WI 55.0 55 M 02/05/2001 I have received all 3 Lymerix vaccine shots. The last being on 11/17/00, within a few months of the 1st vaccinations on 12/99 and 11/99. I began experiencing soreness and stiffness in both wrists and my right elbow. It has continued and seems chronic. U 11/17/2000 NONE PUB PUB NONE NONE NONE 1
0166418 03/05/2001 CA 0.4 F On the evening that the baby received IZ's, baby had choking type episode. The baby became pale, white lips and gums; eyes rolled back in head. Slight shivers often but no twitching. Father gave mouth to mouth breathing. Did not go to ER. Pt was seen in office on 1/14/00. Spoke with doctor on 1/12/00. Y 12/11/2000 12/11/2000 0 CBC, Chem 18, EEG PVT OTH Diaphragmatic and eventration; ROD secondary to her poor feeding 1
0166419 03/05/2001 DE 1.08 1 .1 M 02/05/2001 Seizure within 24 hours of vaccination. Y U 01/24/2001 01/25/2001 1 PVT PUB Anemia Left intrarenal pelvis 1
0166420 03/05/2001 FL 1.0 1 .0 F 02/07/2001 MMR; rash. U 01/24/2001 02/06/2001 13 PUB OTH NONE NONE NONE 1
0166421 03/05/2001 VA 0.5 0 .5 M 02/22/2001 Urticarial type rash (erythema/blotchy and blanching rash) around areas of stick sites (legs), on arms and across chest. Mom reports, started around site of Prevnar injection. Y Y 12/01/2000 12/02/2000 1 NONE PVT PVT NONE NONE NONE 1
0166422 03/05/2001 ME 0.2 0 .2 M "Crying inconsolably, all night, following vaccine administration". Y 12/11/2000 12/11/2000 0 NONE PVT PUB NONE NONE NONE ME01006 1
0166423 03/05/2001 VA 1.2 1 .1 F 02/08/2001 3 little dots on face on 2/4/01; 3 dots on arm on 2/5/01 and all over body on 2/6/01. Saw pediatrician on 2/6/01. Rash continues over body but not on palms of hands. Is fading at the present time. No fever. Y N 01/23/2001 02/03/2001 11 PUB UNK NONE NONE Uvula cyst 1
0166424 03/05/2001 NJ 2.0 2 .9 M 01/31/2001 Urticaria of right upper arm and left face. No wheezes or difficulty with breathing. Y Y 01/30/2001 01/30/2001 0 NONE OTH OTH 1
0166425 03/05/2001 MA 0.5 0 .5 F 02/02/2001 Child began high pitched scream about 1 hour, post vax, lasting about 45 minutes. Later in the day, a red line was noted from the injection site followed by hot, red, local reaction. Local reaction persisted through 2/2/01 AM visit. Y Y 02/01/2001 02/01/2001 0 PVT PUB Motrin at time of visit Mild cold symptoms NONE 1
0166426 03/05/2001 MI 0.3 0 .4 M 01/31/2001 At 15:00, gave injection of DTAP and HIB (2 different sites, same right thigh) leg became bright red in color, a few bumps noted; I got the doctors to look at baby and we administered 1/2 tsp Benadryl. The pt is to follow-up with an allergist. Y 01/31/2001 01/31/2001 0 PVT PVT NONE NONE 1
0166427 03/05/2001 WI 72.0 70 M 01/30/2001 Pain in joints; elbow and shoulder; persistent ache; tender to touch at times with stiffness. Continued complaints but no worsening. There were 3 Lymerix given starting with 1st on 4/29/99, 2nd on 6/1/99 and 3rd on 5/1/00. U 06/01/1999 06/01/2000 366 NONE PVT PVT NONE NONE NONE 1
0166428 03/05/2001 IN 1.75 1 .8 F 02/19/2001 Fever of 104F within 24 hours, post vax. No local reaction. Y U 02/14/2001 02/15/2001 1 Urine dip-(-); Urine culture-No growth PUB PUB NONE NONE NONE 1
0166429 03/05/2001 TX 1.0 1 .0 F 01/30/2001 Rash, (papulo-vesicular) on trunk, noticed on 1/28/01 and a fever. Exam on 1/29/01. Y Y 01/18/2001 01/27/2001 9 PVT PVT Fever and rash 1
0166430 03/05/2001 MD 37.0 37 F 02/02/2001 Left arm almost immovable due to massive swelling; left side, all the way down to hip is numb and almost immovable due to unbearable pain; rash and redness developed from top of shoulder to elbow with large lump, near injection site, the size of a tennis ball under muscle mass; several light-headedness and complete blackouts with rapid increase in heart rate; rapid heart rate/palpitations and profuse sweating onsets, while sitting stationary. Y U 01/23/2001 01/23/2001 0 EKG; Urine and Blood samples drawn. MIL MIL Ortho-Tri-Cyclen (birth control) NONE Demerol and ragweed allergies. 1
0166431 03/05/2001 TX 2.0 2 .3 F 02/05/2001 At time of injection, the site of PCV, bled real bad. Was able to apply pressure and a bandaid. Child was seen on 1/31/01 for rash reaction. Mom states left thigh was worse. Child had complete body rash and was instructed to use OTC. Y Y 01/30/2001 01/30/2001 0 PVT PUB 1
0166432 03/05/2001 FL 1.5 1 .6 M 01/26/2001 Fever, nausea and vomiting, 24 hours, post vax. Resolved in 48 hours. Rx'd Motrin and fluids. May have been coincidental viral gastrointestinal. Y 01/24/2001 01/25/2001 1 NONE PVT UNK NONE NONE 1
0166433 03/05/2001 TX 19.0 19 M 01/30/2001 Rash around injection site immediately after injection. Pt was instructed by physician to take Benadryl. Rash resolving before pt left the office. Y 01/15/2001 01/15/2001 0 PVT OTH 1
0166434 03/05/2001 OH 42.0 42 F 01/21/2001 Hives for 3 days; arm also sore for 3 days. Had shortness of breath and sinus problems (bloody). U 01/04/2001 01/05/2001 1 OTH UNK NONE 1
0166435 03/05/2001 NC 67.0 67 F Flu vaccine given and 24 hours later, pt noticed hives on legs. Went to Pharmacy and got Benadryl for hives. Three days later, 12/25/00, pt's arms and hands became swollen. Pt went to medical center where the doctor put her on steroids. Pt is doing fine now, 1/25/01. Pt also mentioned that husband got red spots and a fever blister, 12 hours, post flu vaccine. Y Y 12/22/2000 12/23/2000 1 PUB PUB NONE NONE 1
0166436 03/05/2001 AZ 33.0 3 F 01/24/2001 Routine TD given in clinic. Returned, 2 days, later with erythemic area 5" X 3", just proximal to elbow. Tenderness, inflammation. No lesions, no drainage. Y Y 01/12/2001 01/14/2001 2 PUB PUB metformin, Zantac, albuterol, MDI NONE Diabetes; asthma; GERD 1
0166437 03/05/2001 TN 66.0 66 F 01/25/2001 Pt states had chills and fever, the night of the injection of pneumonia and flu vaccines. Right arm was red and swollen the morning after injection but no fever. Y 01/24/2001 01/24/2001 0 PUB UNK Cold 1
0166438 03/05/2001 TX 21.0 31 F 01/28/2001 45 minutes, post vax, she had hives in both legs, lasted a few hours and was gone by morning. Told us about rash on 1/27/01. Y 12/20/2000 12/20/2000 0 OTH OTH Ortho Tri-Cyclen NONE NONE 1
0166439 03/05/2001 IL 58.0 58 F 02/08/2001 Pt experienced redness, pain, swelling and warmth on left upper and lower arm, the night of the injection. RN was notified the next morning. Instructed pt to take ibuprofen and consult MD. On 12/18/00, she saw MD and was dx'd with cellulitis and placed on Keflex. Contact made on 12/20/00 and condition is much improved. Y Y 12/15/2000 12/15/2000 0 NONE OTH PVT UNK NONE NONE 1
0166440 03/05/2001 IL 58.0 58 F 02/08/2001 Pronounced edema, redness and itching at injection site on right arm. Ice applied. Refused antihistamine. Arm checked in 30 minutes; at 45 minutes had swelling of right eye. Chlo-Amine tablets (4) given. Arm slowly improved. Continued with ice. Instructed to take Benadryl at home and call MD if condition worsens. At 16:00, arm checked and was much improved. Y 12/15/2000 12/15/2000 0 NONE OTH PVT UNK NONE NONE 1
0166441 03/05/2001 IL 39.0 39 F 02/08/2000 Redness, warmth and pain in right arm, noted on 12/16/00. Pt applied ice and took Tylenol on 12/16/00. Reaction lasted approx. 3 days. Required no medical attention. Follow-up call on 12/19/00, pt states fully recovered. Y 12/15/2000 12/16/2000 1 NONE OTH PVT UNK NONE NONE 1
0166442 03/05/2001 UT 0.4 F 02/16/2001 Information was received from the physician concerning a 17 week old pt with upper respiratory infection, post vaccine in the left thigh. Pt was irritability and prolonged crying. Pt experienced injection site erythema (10x10) cm, pt was treated with Tylenol pt was monitored by physician. Pt was sleeping and the symptoms resolved. Mother also reported that pt has similar reaction at 2 months of age with redness on both legs. The pt also experienced red irritated site with another vaccine. Y Y 01/11/2000 PVT PUB Concurrent conditions: upper respiratory infection. Pt experienced ijection site erythama, with crying,injection site pain, injection site warmth and irritability.~DTaP (Acel-Imune WAES00011060 1
0166443 03/05/2001 ME 11.0 11 M 02/16/2001 Information received from a physician, pt received vaccine in right deltoid. Pt developed local tenderness. Treated with application of cold compress, pt recovered Y Y 02/28/2000 02/28/2000 0 PUB PUB UNK UNK WAES00022483 1
0166444 03/05/2001 TX 0.4 0 .4 F 02/16/2001 18 week old pt received vaccine in right leg. reports swelling at injection site, erythema and pain at injection site. Mother reports similar experience in January 2000 post vaccine. Y Y 03/13/2000 03/13/2000 0 PVT PUB WAES00060798 1
0166445 03/05/2001 TX 0.3 0 .3 F 02/16/2001 Physician reports pt irritable, crying, skin warm to touch post vaccine. Per physician pt recovered. Y Y 05/22/2000 05/22/2000 0 NONE PVT PUB NONE Pt experienced fever, irritability, vomiting and crying post comvax~Vaccine not specified (no brand name)~~0.00~In Patient WAES00060804 1
0166446 03/05/2001 SC 1.0 U 02/16/2001 Reported induration at injection site, warmth at injection site, wheal at injection site. On June 5th 2000 the patient experienced a local reaction to vaccine, red welt on the arm that was warm to touch. The area was 1 1/2 x 2 1/2 cm and hard Y 06/02/2000 06/05/2000 3 OTH OTH UNK UNK WAES00061424 1
0166447 03/05/2001 NC 0.2 0 .2 F 02/16/2001 Injection site swelling, hyperkinesia, personality change,pt was very hyper injection site induration. Y U 11/07/1997 PVT PVT Concurrent conditions: dye allergy. WAES00063172 1
0166449 03/05/2001 NJ 0.17 U 02/16/2001 Information received by a registered nurse concerning pt with reaction at injection site, crying, pain at injection site. Pt experienced similar reaction post other vaccine's. Y U OTH OTH UNK ~Measles + Mumps (no brand name)~1~1.20~In Sibling WAES00091389 1
0166450 03/05/2001 WV 28.0 27 F 04/19/2001 A nurse reported pt had facial swelling post injection, itchy eyes and sore neck and shoulders. She was treated with Prednisone. Follow-up info received on 04/17/2001 indicated that the pt also developed redness and swelling at the injection site. She recovered. Y 08/09/2000 08/10/2000 1 UNK PVT PVT NONE NONE UNK HQ0114122AUG2000 1
0166452 03/05/2001 GA U 02/25/2000 A nurse reported a pt post vaccine she developed swelling, warmth,redness and a rash. The pt was treated in the ER. Y U 01/22/2000 01/22/2000 0 UNK PUB OTH UNK UNK UNK HQ0765928JAN2000 1
0166453 03/05/2001 IL 68.0 68 F 02/17/2000 A nurse reported that a 68 year old received a vaccine on Jan 12, 2000. Pt developed injection site reaction characterized by a 3 to 4cm area of redness and warmth. She was treated with Kelflex, on 1/19/2000, she was treated with Rocephin IM, after she developed little red spots and redness that extended down to the forearm. She was treated with Medrol dose pack. Y U 01/12/2000 01/17/2000 5 UNK OTH OTH Fosamax, Norvasc, Prempro, Toprol XL, Zocor. UNK Hypercholesterolanemia, Hypertension 977608 1
0166454 03/05/2001 TX 19.0 19 F A nurse reported that a pt received vaccine on 3/7/2000 and on 3/8/2000, the pt developed transient fever, malaise, hypotension, nausea, and arthralgia. The pt recovered. Y 03/07/2000 03/08/2000 1 UNK PVT PVT Aplisol NONE UNK HQ1492810MAR2000 1
0166455 03/05/2001 NC 76.0 76 F 03/31/2000 A nurse reported that a pt received vaccine on 3/10/2000, later that night she experienced a reaction to the injection site, characterized by redness, heat, bruising and induration. Pt self treated with warm soaks. The physician treated with ice applications and ibuprofen. Follow-up info received from the reporter on 01/25/2001 indicated that the pt recovered. Y 03/10/2000 03/10/2000 0 UNK PVT PVT Acetylsalicylic Acid, Calcium, Fosamax, Synthroid, Lecithin, Xalantan, Multivitamin, Vitamin C,D,E NONE UNK HQ1681120MAR2000 1
0166456 03/05/2001 MD 35.0 U 10/10/2000 A nurse reported that a 35 year old pt received vaccine and developed fever and headache. Pt also developed large reaction to injection site characterized by redness, swelling and warmth, extending from shoulder to elbow. U UNK PVT OTH UNK NONE UNK HQ1740603OCT2000 1
0166457 03/05/2001 NY 12.0 12 M 10/26/2000 A nurse reported that pt received vaccine, the next day he developed a reaction, which the reporter did not describe. He recovered. Y 02/24/2000 02/25/2000 1 UNK PVT OTH UNK UNK Concurrent conditions: Hypersensitivity NOS HQ1926109OCT2000 1
0166460 03/05/2001 FL 51.0 51 M A nurse reported pt received vaccine on 10/30/2000, subsequently he developed nausea, chills, sleepiness, achiness, dark colored urine and was unable to get warm. Also developed reaction at injection site, reaction characterized by 3" by 4" area of redness, swelling, inflammation and warmth. Y U 10/30/2000 OTH OTH UNK UNK 3498210 1
0166461 03/05/2001 CO 36.0 36 M 06/07/2000 A nurse reports pt received vaccine 3/21/2000, he was seen by physician on 3/23/2000 for injection site reaction characterized by a 5cm area of induration, warmth and pain. He did not require treatment. Y U 03/21/2000 03/23/2000 2 UNK OTH OTH NONE Infected blister on hand UNK HQ5370504MAY2000 1
0166462 03/05/2001 CA U 06/27/2000 A pharmacist reported that a pt received vaccine on 5/1/2000, or 5/2. 15 to 30 minutes later pt developed severe cellulitis at the injection site. Pt was seen by physician who prescribed a single IV dose of Cefazolin. Y U 05/01/2000 05/01/2000 0 UNK PVT PVT UNK NONE UNK HQ6162319MAY2000 1
0166463 03/05/2001 GA 40.0 40 F 06/27/2000 A nurse reported a pt received a vaccine on 4/6/2000 and subsequently developed a severe injection site reaction characterized by a hive-like area of swelling, redness and induration which resembled cellulitis. Pt also developed swollen lymph nodes under the left arm. On 4/11 pt was treated with Prednisone. On 4/11/2000 pt developed shortness of breath, anxiety, malaise, general achiness,arm pain and fever. Y U 04/06/2000 UNK PVT OTH UNK Cut on finger UNK 6266522 1
0166465 03/05/2001 PA 32.0 32 M 07/12/2000 Medical Assistant reported a pt with history of chronic pain and possible fibromyalgia received a vaccine on 6/7/2000. The next day pt developed severe arm pain, arm numbness and weakness. In the following day the pt experienced pain almost everywhere had difficulty sleeping and eating and lost 9 pounds. U 06/07/2000 06/08/2000 1 UNK PVT PVT Nortriptline, Oxycotin, Wellbutrin -SR second degree sunburn HQ7560120JUN2000 1
0166466 03/05/2001 TX 56.0 56 F 01/08/2001 A nurse reported a pt received a vaccine on 3/23/2000, on 4/26/2000 she developed an injection site reaction characterized by redness, warmth and indented skin. Pt recovered Y 03/23/2000 04/26/2000 34 UNK OTH OTH aspirin, calcium, vitamins cat bite HQ7953328JUN2000 1
0166467 03/05/2001 LA 48.0 48 F 07/14/2000 Pt reports she received vaccine on 4/21/2000. Post vaccine she developed rash on her arm. The rash then became generalized; itched and burned. The rash persisted as of 7/6/2000. U 04/21/2000 04/21/2000 0 UNK PVT OTH UNK NONE HQ8270107JUL2000 1
0166468 03/05/2001 NY 40.0 F 10/06/2000 A pharmacist reported a pt received a vaccine on 4/20/2000. The next day pt developed a fever of 103 deg F, reaction characterized by redness and swelling. The fever ad injection site reaction resolved after 3 days. Y 04/20/2000 04/21/2000 1 UNK PVT OTH UNK NONE UNK HQ8444112JUL2000 1
0166469 03/05/2001 IL 43.0 F 10/06/2000 a pharmacist reported that a pt received a vaccine on 6/27/2000. Two days post vaccine she developed fever and flu like symptoms, which lasted more than 36 hours. Pt also developed a 15 cm area of soreness at injection site. On 7/1/2000 pt was treated by physician. Y U 06/27/2000 06/29/2000 2 UNK OTH OTH Nedocromil UNK Asthma NOS 8492513 1
0166470 03/05/2001 IL 51.0 F 10/03/2000 A pharmacist reports a pt received vaccine 7/4/2000, that same day she developed a fever and flu like symptoms which lasted more than 36 hours. The pt also developed a 15cm area of soreness at the injection site. U 07/04/2000 07/04/2000 0 UNK OTH OTH UNK UNK UNK 8493213 1
0166471 03/05/2001 OH 13.0 13 M 02/01/2001 A nurse reported pt received vaccine on 7/10/2000, on 7/11 pt awoke with injection site reaction characterized by redness, swelling, and tenderness at the injection site. Pt was also nauseous, then became dizzy and pale and had blurred vision these symptoms lasted approximately 5 minutes. Pt felt feverish, but did not take his temperature. His mother treated him with dihenhydramine, acetaminophen, and applications of ice to the injection site. By 07/12/2000, only the injection site swelling and tenderness remained. The pt's last injection of diphtheria and tetanus toxoids was in 1992. Concomitant vaccine given on 07/10/2000 is Engerix-B. U 07/10/2000 07/11/2000 1 NONE OTH OTH UNK UNK Otitis externa HQ8570817JUL2000 MPI20001 1
0166473 03/05/2001 WY 29.0 M 06/26/2000 A HCP reported a pt received a vaccine 6/23/2000, on 6/26 he developed an injection site reaction characterized by 6cm by 8cm area of warmth, erythema, swelling and tenderness. He was treated in the ER and diagnosed with cellulitis. He recovered Y Y 06/23/2000 06/26/2000 3 OTH OTH Laceration 917228 1
0166474 03/05/2001 VA 48.0 48 F 12/27/2000 A nurse reported a pt received vaccine on 7/24/2000 and subsequently developed an irregular heart beat, chills, and chest pain which resolved within 24 hours. Pt also developed an injection site reaction characterized by swelling and pain. She reported these events to her MD on 7/28/00 when the injection site remained mildly tender. Additional info received from the reporter on 01/25/2001 indicated that the pt recovered Y 07/24/2000 07/24/2000 0 PVT PVT HQ9198631JUL2000 1
0166475 03/05/2001 NY U 08/04/2000 A nurse reported pt received vaccine on 7/19/200 and subsequently developed an injection site reaction characterized by redness, festering, swelling and pain. U 07/19/2000 PVT OTH HQ9290301AUG2000 1
0166476 03/05/2001 IL 21.0 M 08/09/2000 A pharmacist reported a pt received vaccine on 8/1/00, later that day he developed injection site reaction characterized by redness, swelling and pain. U 08/01/2000 08/01/2000 0 OTH OTH 9458204 1
0166477 03/05/2001 WY 21.0 F A HCP reported post vaccine pt developed an injection site reaction characterized by 2cm palpable area of swelling and tenderness. Pt was treated in the ER and diagnosed with cellulitis, a moderate amount of pus was removed from the right arm an Penrose drain was inserted and sutured in place. Y U 06/16/2000 06/24/2000 8 OTH OTH Amitriptyline, Nortriptyline, Ibuprofen Puncture wound Concurrent Conditions: Depression NEC HQ9474207AUG2000 1
0166478 03/05/2001 U 08/15/2000 A nurse reported post vaccine pt reported the next day, developed injection site reaction characterized by a 4.5 to 5cm area of redness, warmth, itching, induration, tiny blisters and pain described as feeling bruised on the inside. U 08/01/2000 08/02/2000 1 OTH OTH HQ9542208AUG2000 1
0166479 03/05/2001 MD 43.0 43 F 08/15/2000 A pharmacist reported that a received a vaccine on 7/2000, Pt subsequently developed cellulitis at injection site. Pt treated with antibiotics and recovered. Follow-up info received on 01/23/2001 from the reporter indicated that the pt was immunized on 07/25/2000. The cellulitis, requiring a physician visit, occurred the following day on 07/26/2000. The pt has a histroy of pcn allergy and allergy to "environmental agents." Y Y 07/25/2000 07/26/2000 1 NONE PVT OTH UNK NONE PCN and environmental agents allergy HQ9564508AUG2000 1
0166480 03/05/2001 OH F 03/03/2000 A nurse reported that a pt received vaccine 1/6/00, several days post vaccine pt developed an injection site reaction characterized by redness and induration. Pt recovered. Y 01/04/2000 01/06/2000 2 OTH OTH UNK NONE UNK 040861 1
0166481 03/05/2001 WI F A pharmacist reported that a female in her 40's received an injection of Tetanus and Diphtheria Toxoids Adsorbed, Ultrafined on 12/01/99. On 12/02/99, the patient developed an injection site reaction characterized by swelling and tenderness "more severe than usual". The patient was treated with Vioaxx and Claritin. She recovered on 12/09/99. Y 12/01/1999 12/02/1999 1 PUB PVT NONE NONE UNK HQ0666521JAN2000 1
0166482 03/05/2001 AK U 10/17/2000 A territory representative reported that a pt received vaccine and subsequently developed a severe injection site reaction characterized by swelling and redness. U UNK OTH OTH UNK UNK UNK HQ1711603OCT2000 1
0166483 03/05/2001 NY 48 F 02/27/2001 A nurse reported that a female received an injection of Tetanus Diphtheria Toxoids Adsorbed, Ultrafined (Wyeth) on 03/09/00. She subsequently developed an injection site reaction characterized by a "baseball" size area of swelling, redness, and tenderness. Follow up info received from the physician on 10/06/00, indicated that the patient was a 48 year old female who experienced the adverse event on 03/11/00. The patient recovered. Y 03/09/2000 03/11/2000 2 UNK PVT PVT UNK UNK UNK HQ2064504APR2000 1
0166484 03/05/2001 WA 64.0 64 F 04/24/2000 A physician reported that a pt received vaccine on4/7/00, on 4/10/00 pt developed a 18cm by 10cm area of redness and was treated and recovered. Follow-up info received from the physician on 04/02/2001 indicated that this pt has a medical history inclusive of hypertension. The pt remained recovered. Y Y 04/07/2000 04/10/2000 3 UNK PVT OTH UNK UNK Hypertension NOS, cigarette smoker, appendicectomy HQ3966221APR2000 1
0166485 03/05/2001 MD 36.0 36 F 07/11/2000 A medical assistant reported that a 36 year old female received an injection of Tetanus Diphtheria Toxoids Adsorbed, Ultrafined (Wyeth) on 04/18/00. On 04/23/00, the patient developed a large hive which was described as red, sore, and itchy. U 04/18/2000 04/23/2000 5 PVT PVT NONE NONE UNK HQ4694327APR2000 1
0166486 03/05/2001 MI 75.0 74 F 07/11/2000 A medical assistant reported that a 75 year old female received an injection of Tetanus Diphtheria Toxoids Adsorbed, Ultrafined and Pnu-Imune 23 vaccines on 05/02/00. One week later, the patient developed an injection site reaction characterized by redness and soreness at the site of the TD administration. U 05/02/2000 05/09/2000 7 UNK PVT PVT UNK NONE UNK HQ5676510MAY2000 1
0166487 03/05/2001 NY M 07/11/2000 A nurse reported a pt received vaccine on 3/9/00, he subsequently developed an injection site reaction characterized by a baseball size area of swelling, redness and tenderness. U 03/09/2000 03/09/2000 0 UNK PVT PVT UNK UNK UNK HQ6056218May2000 1
0166488 03/05/2001 CA U A pharmacist reported a pt received a vaccine 5/1 or 5/2/00, 15 minutes later the pt developed an injection site reaction characterized by induration, severe pruritus and redness. U 05/01/2000 05/01/2000 0 UNK PVT PVT UNK NONE UNK HQ6846205JUN2000 1
0166489 03/05/2001 NY 70.0 70 M 07/14/2000 Pt reports post vaccine on 5/15/00, on 5/25/00 he developed hives. The pt recovered. Follow up #1 (5/15/02): during internal auditing of all files, it was deemed necessary to amend the report by updating the adverse coding (corrected vesiculobullos rash to maculopapular rash). Y Y 05/15/2000 05/25/2000 10 UNK PVT PVT NONE UNK HQ6924106JUN2000 1
0166490 03/05/2001 MO U 06/21/2000 A physician reported that 4-5 patients "over the last 4 months" developed "severe localized reactions" following receipt of Tetanus and Diphtheria Toxoids Adsorbed, Ultrafined Lot # 4998366. MANUFACTURERS COMMENT: The reporter was unable to specify the number of patients involved. Additional reports will be generated when identifying information is provided. This report was received from Medeva (Ref # MPI-2000-04566). Y UNK UNK HQ7337014JUN2000 1
0166491 03/05/2001 MI U 07/11/2000 A medical assistant reported pt received a vaccine and1 week later developed injection site reaction characterized by redness, and soreness. U PVT PVT UNK NONE UNK HQ7450116JUN2000 1
0166492 03/05/2001 MI 49.0 49 F 07/11/2000 A medical assistant reported that a pt received vaccine on 4/21/00, one week later she developed and injection site reaction characterized by large area of redness, swelling. U 04/21/2000 04/28/2000 7 UNK PVT PVT NONE NONE UNK 745216 1
0166494 03/05/2001 NY 59.0 F 10/06/2000 A pharmacist reported a pt received a vaccine on 5 26/00, the next day she developed a fever of 103 deg F and an injection site reaction characterized by pain and swelling. She recovered after 3 days Y 05/26/2000 05/27/2000 1 UNK PVT OTH UNK NONE UNK HQ8834321JUL2000 1
0166495 03/05/2001 IL 31.0 F 12/27/2000 A physician reports a pt received vaccine on 7/6/00, she awoke on 7/14/00 with an injection site reaction characterized by a 5cm area of induration, swelling and tenderness that made it difficult to raise her arm. She was treated and recovered. Y Y 07/06/2000 07/14/2000 8 UNK OTH OTH UNK UNK UNK HQ9180131JUL2000 1
0166496 03/05/2001 NJ U 08/15/2000 A medical supplier reported a pt received vaccine and subsequently developed a bad injection site reaction characterized by redness and swelling. U UNK PVT OTH UNK UNK UNK HQ9484807AUG2000 1
0166497 03/05/2001 PA 8.0 8 M 08/15/2000 A physician reported a pt received vaccine on 7/11/00 and subsequently developed induration at the injection site. The child's previous dose of Tetanus toxoid was administered when the child was two years of age. Additional info received on 03/01/2001 from the reporter provided the pt's date of birth, county of administration, recovery status, product lot number, concurrent illness, and concomitant medication. The reporter noted that at the time of immunization the child received Tetanus and Diphtheria toxoids adsorbed, Ultrafined,a nd that he was suffering from allergic rhinitis for which he was prescribed Dimetapp. The child recovered from the event. Y 07/11/2000 UNK OTH OTH Dimetapp UNK Allergic rhinitis HQ9534807AUG2000 1
0166498 03/05/2001 NJ U 12/21/2000 A territory representative reported that several children received an injection of Acel-Imune and subsequently developed an injection site reaction characterized by "severe" swelling, redness and warmth. U UNK PVT PVT UNK UNK UNK HQ0635005SEP2000 1
0166499 03/05/2001 TX 5.0 5 M 10/17/2000 A pt's mother reported that her son received vaccine on 9/5/00, the vaccine was administered closer to the elbow than the deltoid and may have been SQ. On 9/6/00 the pt developed an injection site reaction characterized by swelling, hardness, redness, tenderness, and a bump. U 09/05/2000 09/06/2000 1 UNK OTH OTH serum physiological UNK UNK HQ0865511SEP2000 1
0166500 03/05/2001 OH 41.0 40 F 12/27/2000 A nurse reported a pt with a history of sensitivity to egg whites inadvertently received an injection of Acel-Imune on 8/28/00. She also received vaccine of PPD. Later that day she developed achy joints, profuse sweating and a feeling of being tired. The reporter indicated that the reaction was similar to the one the pt has when she eats egg whites. The pt was treated and recovered; however still had some leg discomfort now and again but felt better. Y U 08/28/2000 08/28/2000 0 UNK PVT OTH Tuberculin PPD (Mantoux) UNK Concurrent conditions: food allergy HQ0944213SEP2000 1
0166501 03/05/2001 CA U 10/16/2000 A territory representative reported that a pt received vaccine and subsequently developed swelling at the injection site. U UNK PVT OTH UNK UNK UNK HQ1066715SEP2000 1
0166502 03/05/2001 IL 5.0 0 .4 F 01/08/2001 A nurse reported that pt received vaccine 7/11/00, approximately 10 minutes post vaccine the pt developed hives and swelling at the injection site, with hives all over the leg. Y Y 07/11/2000 07/11/2000 0 UNK PUB OTH UNK NONE UNK HQ2194113OCT2000 1
0166503 03/05/2001 VA 1.6 3 M 12/27/2000 A territory representative reported that a pt received vaccine. On 9/23/00, the pt developed swelling at the injection site. U 09/28/2002 09/23/2000 UNK PVT OTH UNK UNK UNK HQ2466119OCT2000 1
0166504 03/05/2001 VA 1.9 2 .1 M 12/27/2000 A territory representative reported that a pt received vaccine. On 9/23/00 pt developed swelling at injection site. Follow-up received from the physician on 01/25/2000 indicated that the child received both Acel-Imune and IPV vaccines on 09/28/2000. On 09/30/2000, he developed swelling at an unspecified injection site. He was treated with amoxicillin/clavulanic acid and diphenhydramine. He recovered. Y 09/28/2000 09/30/2000 2 NONE PVT OTH UNK NONE UNK HQ2474319OCT2000 1
0166505 03/05/2001 FL 1.5 1 .5 M A nurse reported pt received vaccine on 11/13/00, the next day pt developed injection site reaction characterized by a 4" area of redness, warmth, and swelling. Y 11/13/2000 11/14/2000 1 UNK PVT OTH NONE NONE UNK HQ3849517NOV2000 1
0166507 03/05/2001 NY 0.2 0 .2 F 12/27/2000 A pharmacist reported a pt received vaccine 11/8/00. A nasopharyngeal culture was performed; the result was positive for pertussis. Additional info received from the reporter on 01/25/2001 indicated that the pt concomitantly received IPV on 11/08/2000, on 11/09/2000 Prevnar and Comvax. The reporter noted that the pt has a concurrent history of Hirschsprung's disease. Y 11/08/2000 culture nose positive for pertussis PVT OTH UNK UNK Congenital megacolon HQ4180728NOV2000 1
0166508 03/05/2001 IL U 12/27/2000 A pharmacist reported a pt received a vaccine, shortly after injection the pt developed a raised hive at the injection site. U UNK OTH OTH UNK UNK UNK HQ4340101DEC2000 1
0166509 03/05/2001 FL 1.3 1 .4 F 01/10/2001 A nurse reported that a pt received vaccine on 11/13/00, the next day she developed an injection site reaction characterized by a 4" area of redness, warmth and swelling. Y Y 11/13/2000 11/14/2000 1 PVT OTH Proventil NONE UNK HQ4436104DEC2000 1
0166510 03/05/2001 VA U 10/17/2000 A nurse reported that pt received a vaccine and subsequently developed an injection site reaction. U UNK OTH OTH UNK UNK UNK HQ1598329SEP2000 1
0166511 03/05/2001 WI 5.0 5 M 01/09/2001 Physician reported pt received vaccine on 10/6/00, on 10/8 he developed a generalized rash over his upper body. As of 10/18, the rash persisted. Pt did recover. Y 10/06/2000 10/08/2000 2 UNK PVT OTH vitamins UNK UNK HQ2630823OCT2000 1
0166512 03/05/2001 IL 0.3 M 12/15/2000 A physician reported a pt received vaccine and subsequently developed a rash. U UNK OTH OTH UNK UNK UNK HQ4658708DEC2000 1
0166513 03/05/2001 NY 0.4 0 .5 M 01/08/2001 A physician reported that his grandson received a vaccine on 5/24/00, on 5/25/00 he developed an ear infection and fever. The reporter indicated that he was not able to determine if the ear infection was present at time of vaccination. The pt recovered. Y 05/24/2000 05/25/2000 1 UNK OTH OTH UNK NONE UNK HQ5310328DEC2000 1
0166514 03/05/2001 NE 26.0 26 M 12/14/2000 A Nurse reported that a pt received a vaccine 8/14/00, on 8/16/00 pt developed plugged sinuses and an injection site reaction characterized by 115mm by 90mm area of warmth, mild swelling, redness, soreness, and a quarter size lump. U 08/14/2000 08/16/2000 2 UNK PVT OTH NONE NONE UNK HQ0111622AUG2000 1
0166515 03/05/2001 RI 18.0 18 F 03/27/2000 Pt received vaccine on 1/31/00, on 2/1/00 she developed an injection site reaction characterized by redness, swelling. U 01/31/2000 02/01/2000 1 UNK PVT OTH NONE NONE UNK HQ0890203FEB2000 1
0166516 03/05/2001 WI 31.0 31 F 12/15/2000 A physician reported a pt received vaccine on 8/8/00, approximately 1 hr post vaccine she developed a fever of 102F and a flat irregular rash on her trunk, the pt also felt ill and weak. Pt recovered. U 08/08/2000 08/08/2000 0 UNK PVT OTH Prozac NONE UNK HQ0900412SEP2000 1
0166517 03/05/2001 F 02/22/2000 A pt reported that she received a vaccine 12/99 and subsequently developed lymphadenopathy in her groin. The pt is being seen by the physician; the lymphadenopathy persists. Y U UNK OTH OTH UNK UNK UNK HQ1106317FEB2000 1
0166518 03/05/2001 OH 44.0 44 F 03/30/2000 Pt received vaccine 7/19/99 and subsequently developed an injection site reaction characterized by pain and swelling. U 07/19/1999 UNK PVT OTH NONE UNK UNK HQ1186223FEB2000 1
0166520 03/05/2001 GA 18.0 18 M 04/04/2000 A mother reported that her son received vaccine on 2/26/00 and on 2/27/00 he developed an injection site reaction characterized by redness and swelling, reportedly the size of a softball. His symptoms have persisted. U 02/26/2000 02/27/2000 1 UNK MIL MIL NONE UNK UNK HQ1304401MAR2000 1
0166521 03/05/2001 UT 19.0 M 05/26/2000 A nurse reported that a pt received a vaccine on 2/23/00 and within 24 hrs developed flu like symptoms and an injection site reaction the size of an orange, characterized by a red swollen arm. Y 02/23/2000 02/24/2000 1 UNK PVT OTH UNK NONE UNK HQ1345802MAR2000 1
0166522 03/05/2001 MN 21.0 21 F 08/31/2000 A nurse reported a pt received vaccine's on 2/22/00, within 24 hrs she developed a fever of 101.1F, headache and generalized body aches. She recovered. Y 02/22/2000 02/23/2000 1 UNK PVT PVT NONE NONE UNK HQ1767823MAR2000 1
0166523 03/05/2001 IA 71.0 M 04/13/2000 A physician reported a pt received vaccine's first wk of Feb, 2000. Within a week the pt developed muscle stiffness, knee pain and swelling in both hands. U Erythrocyte sedimentation rate- elevated at 61, C-reactive protein elevated. PVT OTH Lariam NONE Concurrent Conditions; myalgia HQ1800124MAR2000 1
0166524 03/05/2001 WA 3.0 3 M 12/22/2000 A nurse reported a pt received vaccines on 10/4/00. The next day the child developed soreness at injection site. U 10/04/2000 10/05/2000 1 PVT OTH HQ1954909OCT2000 1
0166525 03/05/2001 CA F 05/05/2000 Pt received vaccine 3/30/00 and subsequently developed an injection site reaction characterized by redness and warmth. U 03/30/2000 PUB OTH HQ2464310APR2000 1
0166526 03/05/2001 UT 19.0 M 01/05/2001 The pt developed and injection site reaction characterized by redness and swelling. U 11/01/2000 UNK PVT OTH UNK UNK UNK HQ3338607NOV2000 1
0166527 03/05/2001 NM 42.0 F Subsequently pt developed swollen lymph nodes in the groin area which lasted several weeks, she also developed an injection site reaction characterized by swelling and soreness which lasted 4 days. Y PVT OTH HQ3536218APR2000 1
0166528 03/05/2001 GA 1.2 1 .2 F 07/19/2000 Approximately 1.5 hrs post vaccine pt awoke crying and shaking. Mother noticed while child was sleeping that her lips were blue and she was trembling. Y 04/20/2000 04/20/2000 0 PVT OTH Immune Serum Globulin HQ4478525APR2000 1
0166529 03/05/2001 CA 33.0 F 12/27/2000 Pt reported injection site swelling within hrs developed local swelling on arm the size of a baseball. Y 11/13/2000 11/13/2000 0 PVT PVT HQ4746112DEC2000 1
0166530 03/05/2001 CO 49.0 49 F 08/31/2000 Pt reports approximately 2 hrs post vaccine she developed an injection site reaction characterized by redness and swelling, she then developed a fever and muscle aches. Y 04/26/2000 04/26/2000 0 PVT PVT HQ5322203MAY2000 1
0166531 03/05/2001 TX U 05/09/2000 Pt reported injection site swelling the size of an egg. Y OTH OTH HQ5362804MAY2000 1
0166532 03/05/2001 CA 45.0 45 F 08/31/2000 Pt experienced nausea and diarrhea post vaccine, also fever. She reports she has lost 6 to 7 lbs, she also developed induration and tenderness in L3 area. Pt also has nodule at injection site. Pt recovered. Y 04/27/2000 04/28/2000 1 pregnancy test - negative, Chemistry NOS - normal, Thyroid function test NOS - Normal. OTH OTH Levothyroxine Concurrent conditions: Thyrotoxicosis, Typhoid fever HQ5524508MAY2000 1
0166533 03/05/2001 NE 26.0 26 M 10/31/2000 Pt reports soreness at the injection site, over the next few days pt developed a fever and blocked sinuses, also developed lethargy, had no energy and couldn't squeeze anything with the hand on the affected arm. Y 05/26/2000 PUB PVT HQ7502119JUN2000 1
0166534 03/05/2001 MT F 08/07/2000 Pt reports developing hives post vaccine. U UNK OTH HQ9268301AUG2000 1
0166535 03/05/2001 IA F 07/14/2000 The pt developed pain in her left deltoid. Y 12/29/1999 UNK PUB OTH UNK NONE UNK HQ0564518JAN2000 1
0166536 03/05/2001 PA 21.0 21 F 06/27/2000 Two days post vax, she developed an injection site reaction with induration, the injection site reaction affected a 12-cm area. U 12/28/1999 12/30/1999 2 UNK PVT PVT PPD NONE UNK HQ0779728JAN2000 1
0166537 03/05/2001 IA 71.0 71 M 04/12/2000 Within one week the pt developed myalgia. U 02/01/2000 02/07/2000 6 UNK PVT OTH Lariam NONE UNK HQ1603715MAR2000 1
0166538 03/05/2001 PA U 10/16/2000 The same day of vax, the pt developed an injection site reactions at the site of the vaccine. U 03/24/2000 03/24/2000 0 UNK OTH OTH UNK NONE UNK HQ2204107APR2000 1
0166539 03/05/2001 PA U 06/07/2000 Within 12 hours, the pt developed an injection site reaction. U UNK OTH OTH UNK UNK UNK 610018 1
0166540 03/05/2001 CA M 07/26/2000 A physician reported that he received an injection of Typhoid vaccine on 4/27/00 and subsequently developed a 4-5 cm area of induration at the injection site. The pt's wife had an adverse event as well. U 04/27/2000 UNK OTH OTH UNK UNK UNK HQ7366515JUN2000 1
0166541 03/06/2001 WI 14.0 14 F 02/12/2001 The pt experienced right deltoid warmth and redness. Not infected. Y 02/08/2001 PVT PVT Differen gel NONE NONE 1
0166542 03/06/2001 OR 0.2 0 .2 M 02/07/2001 The pt experienced a fever up to 103 on the evening of the injection and the mother reported a bluish discoloration around lips. No treatment was given. Y U 02/06/2001 02/06/2001 0 urinalysis, physical - nml PVT PUB NONE NONE NONE 1
0166543 03/06/2001 NH 4.0 4 M 02/09/2001 The pt received vax on 2/1/01. The following day, the pt experienced redness, swelling, warmth at the site of injection. U 02/01/2001 02/02/2001 1 NONE PVT UNK 1
0166544 03/06/2001 OH 13.0 13 F 02/20/2001 The pt broke out in hives in the afternoon of 2/1/01. Was given Prednisone. The pt decreasing dose for 8 days. Also was seen at a hospital for hives. Y U 02/01/2001 02/01/2001 0 NONE PVT PUB NONE NONE allergy to sulfa, erythromycin 1
0166545 03/06/2001 GA 0.3 0 .4 F 02/14/2001 The same day as vax, the pt woke up around 7:30 PM and was crying non-stop. She was taken to the local ER and then transferred to another facility ER. Exam was normal except for gassiness. The pt has calmed down after being swaddled and given Mylicon drops. Y Y 02/13/2001 02/13/2001 0 Chest x-ray - nml, abdominal x-ray, CBC, WBC PVT PVT NONE NONE NONE 1
0166546 03/06/2001 GA 1.3 1 .3 M 02/05/2001 The child experienced crying, scratchy, and broken out. The pt is allergic to dairy products. The pt was sent to the PMD. Y 02/02/2001 02/02/2001 0 PUB UNK NONE allergy to milk, cheese, and eggs 1
0166547 03/06/2001 UT 1.0 0 1 M 02/12/2001 The pt experienced chicken pox spots approximately 300 all over body. They appeared but did not break completely out and scab. Y Y 01/01/2001 01/01/2001 0 PUB PVT fever ~Vaccine not specified (no brand name)~~0.00~In Sibling 1
0166548 03/06/2001 MI 1.5 1 .4 F 02/15/2001 The pt was seen on 2/14/01 had experienced symptoms for several days. The pt experienced lesions localized, dermatome, possible super imposed staph infection also. U 02/01/2001 02/14/2001 13 viral culture - neg PVT UNK NONE NONE 1
0166549 03/06/2001 OR 1.25 1 .3 F 02/09/2001 On 2/7/01 the pt was presented to the ER with a febrile seizure. Y Y 02/06/2001 02/07/2001 1 PVT UNK cough, runny nose 1
0166550 03/06/2001 PA 5.0 4 M 01/09/2001 A 5 year old child with URI symptoms 3-5 days later developed vesicular rash comparative with chicken pox. U 11/01/1999 01/03/2001 429 PVT PVT NONE NONE NONE 1
0166551 03/06/2001 WA 0.6 0 .6 M 02/05/2001 Within seconds of the vax, the pt went into deep anaphylactic shock. Lost consciousness, BP dropped, turned blue-grey, breathing difficulty, remained unconscious for 10 minutes. No treatment given. Was alert within 2 hours. Y 06/01/1999 06/01/1999 0 PVT OTH NONE NONE NONE 1
0166552 03/06/2001 WI 1.0 1 .0 F 01/24/2001 Approximately 4 hours post vax, the pt's Mom reported a fever of 101 axillary, shaking chills. The next day she reported a fever of 102.8 axillary and 2 prolonged episodes of hysterical crying lasting greater than 2 hours. All symptoms resolved by 1/19/01 at 15:00. Y 01/17/2001 01/17/2001 0 NONE PVT PVT NONE NONE NONE inconsolable crying~Pneumo (Prevnar)~1~0.00~In Patient 1
0166553 03/06/2001 TX 7.0 7 F 02/06/2001 One day post vax, the pt has broke out in hives and had an irregular heartbeat. She was placed on Prednisone. Y Y 01/20/2001 01/21/2001 1 OTH OTH NONE NONE seasonal allergies 1
0166554 03/06/2001 WI 84.0 84 F 01/31/2001 4 days post vax, the pt experienced erysipelas swelling in areas of the whole arm. Presumed non-infectious. Y 01/23/2001 01/27/2001 4 PVT PUB 1
0166555 03/06/2001 PA 7.0 2 .0 M 02/08/2001 The pt experienced breakthrough varicella. Y 06/19/1995 02/04/2001 2057 NONE PVT PVT NONE NONE 1
0166556 03/06/2001 NY 1.0 1 .1 F 01/26/2001 The mother described slight difficulty breathing before bed. Gave cough syrup. Upon waking in the AM, Mother noticed puffy face, eyes and bilateral hands. The pt was given Benadryl. Saw MD and assessment was normal. Y Y 01/25/2001 01/25/2001 0 NONE PVT PVT NONE NONE 1
0166557 03/06/2001 MO 5.0 1 .6 F 02/09/2001 The pt broke out with chicken pox on 2/5/01 with approximately 100 spots. The pt was afebrile. Y 12/03/1996 02/05/2001 1525 PVT OTH tear duct obstruction systolic heart murmur with normal EKG 1
0166558 03/06/2001 KY 10.0 M Report of fever 103F, pain all over, screaming, holding head at ears. Y Y 11/20/2000 PUB PUB Zyrtec 1
0166559 03/06/2001 MN 15.0 11 M 02/05/2001 Legs and muscles ached, mind racing, couldn't sleep, restless, not & sweaty,damp, dizziness back ached. Hallucinations at school next day. Y 01/30/2001 01/30/2001 0 PUB PUB ~Pertussis (no brand name)~2~1.50~In Sibling 1
0166560 03/06/2001 CA 1.08 1 .2 M 02/01/2001 Fever, runny nose, cough, and generalized petechial rash. Y Y 01/26/2001 01/27/2001 1 HB= 10.0, platelet count = 6,000 PUB UNK Iron syrup Anemia 1
0166561 03/06/2001 MN 1.25 1 .4 F 02/01/2001 Post vaccine pt had dry cough, and developed hives on face, eye swollen, and hives spread to chest, back, abdomen. Y Y 02/01/2001 02/01/2001 0 PVT PVT Allergy to peanut butter, tomatoes, eggs 1
0166562 03/06/2001 PA 0.3 0 .3 F 01/12/2001 Pt lethargic and sleepy most of day and night, left thigh swollen, red and lumpy at injection site. Y 01/10/2001 01/10/2001 0 PVT UNK Elocon cream Eczema 1
0166563 03/06/2001 TN 30.0 30 F 02/07/2001 Felt real hot, disoriented, dizzy,nauseated, dry mouth, itchy red face, SOB, but no wheezes. Y Y 02/02/2001 02/02/2001 0 Blood sugar 103, pulse ox 100% room air. PVT PUB Iron Shrimp 1
0166564 03/06/2001 OR 30.0 30 F 01/26/2001 Red blotchy rash, itchy, fever. Y 01/22/2001 01/22/2001 0 MIL PVT PPD/Aventis/CO5189AA/1-18-01 Allergic to PCN, ASA. Reye Syndrome 1980 1
0166565 03/06/2001 FL 12.0 12 F 02/06/2001 rash on chest, neck, and back. Complaint of tongue being numb. Y Y 02/06/2001 02/06/2001 0 PUB UNK Allergies to DT,DPT,TD 1
0166566 03/06/2001 FL 4.0 4 F 02/07/2001 The pt experienced swelling to the right lower thigh with erythema. Y 01/23/2001 01/25/2001 2 NONE PVT OTH NONE NONE NONE 1
0166567 03/06/2001 NJ 0.5 0 .6 M On 11/21/00 the pt received vaccines and when went home soon after the baby wouldn't wake up. Was taken to the ER and diagnosed with probably febrile seizure. Mother gave Tylenol when got home for pain. On 12/20/00 received vaccines and the pt cried for hours afterwards. Y Y 11/21/2000 11/21/2000 0 PVT PUB NONE hx of ventilation, CPAP 1
0166568 03/06/2001 MN 42.0 42 F 02/06/2001 The pt received the injection on 12/19/00. She called the clinic on 12/26/00 stating she was seen in the ER and diagnosed with cellulitis at the injection site. The pt complained of arm being numb and swollen. Pt was treated with Keflex. Y U 12/19/2000 PVT PVT NONE NONE NONE 1
0166569 03/06/2001 CA 4.0 4 F 02/08/2001 The pt became faint after the vaccines were administered, The pt experienced sweating, cold skin, shaking, paleness, dizziness. Treated with Benadryl and rest. Y 01/31/2001 01/31/2001 0 glucose - nml PVT PUB NONE NONE NONE 1
0166570 03/06/2001 KS 31.0 31 F 02/05/2001 The pt experienced left arm itching, redness, painfulness, and low grade fever. Y 02/01/2001 02/02/2001 1 MIL UNK NONE NONE 1
0166571 03/06/2001 NY 5.0 4 M 02/19/2001 The pt experienced a rash that lasted one day. No other symptoms. Y 06/08/2000 06/08/2000 0 NONE PVT PUB NONE NONE NONE 1
0166572 03/06/2001 NY 3.0 1 .0 M 02/09/2001 The child was exposed to chicken pox at day care and now has rose petal rash with teardrop center that started on trunk and spread outward. Treated with calamine lotion and Benadryl. Y 12/21/1998 02/09/2001 781 OTH PUB NONE NONE 1
0166573 03/06/2001 IN 0.2 0 .2 F 01/29/2001 The pt cried from 15 min after until 10:00 PM that night. No temp was reported. Baby is ok as of 1/31/01. Y 01/11/2001 01/11/2001 0 PUB PUB NONE NONE IN0011 1
0166574 03/06/2001 IL 1.9 1 .9 M 02/21/2001 The pt experienced a fever of 104, convulsions, chills. The pt went to the ER. Y Y 02/13/2001 02/20/2001 7 PUB PUB NONE NONE NONE 1
0166575 03/06/2001 MI 67.0 66 F The pt noted redness, warmth and tenderness at the injection site for 3-4 days. No swelling. The symptoms cleared spontaneously. Y 02/13/2001 NONE PVT PVT Zocor, Levoxyl NONE NONE 1
0166576 03/06/2001 FL 64.0 64 M 02/20/2001 The pt has continual pain in the arm where the shot was given. The pt has had numerous tetanus shots and never had this problem. It is like someone hit him with a "sledge hammer". The pain is always there. U 12/27/2000 01/03/2001 7 PVT OTH NONE NONE NONE 1
0166577 03/06/2001 MD 9.0 3 M 02/21/2001 The pt started 2/7/01 with 20 pox lesions, then on 2/12/01 had full blown case of varicella. Y 05/25/1995 02/07/2001 2085 PVT PVT NONE ~Varicella (Varivax)~1~13.00~In Sibling|~Varicella (Varivax)~1~4.00~In Sibling 1
0166578 03/06/2001 AL 1.5 1 .5 F 02/07/2001 The pt has an 8 cm are of erythema and induration to the right mid thigh. Treated with ice, heat, and Motrin. Y 02/05/2001 02/06/2001 1 PVT PUB Motrin 1
0166579 03/06/2001 OK 8.0 M 03/01/2001 Report 2001005197-1 describes skin peeling in an 8 year old male who received Hepatitis B vaccine (Engerix-B) for the prevention of hepatitis B. This report was received from the mother of the vaccinee and has not been confirmed by a physician or other health care professional. On 02/07/01 at 8 AM, the vaccinee received his first "pediatric" dose of Engerix-B and the unspecified dose of Hepatitis A vaccine (Havrix). Within 15 minutes post-vaccination, the vaccinee experienced headache, nausea, and vomiting. Both injection sites were warm, edematous, and reddened with blotches. The vaccinee was treated with acetaminophen (Tylenol). By 2 PM, on 02/02/01, the vaccinee developed a fever of 104 F (axillary) which lasted approximately 10 hours. His arms and hands continued to feel "hot" to the vaccinee. On 02/08/01, the vaccinee developed a full body rash. ON 02/09/01, the full body rash got progressively worse; welts with blisters developed "all over" with drainage and itching, headaches, and vomiting persisted. On 02/14/01, the vaccinee's hands and feet were very edematous and sensitive to touch. The vaccinee had not yet been seen by a physician. A nurse told the vaccinee's mother that the vaccinee had "the flu". No treatment was prescribed. On 02/15/01, the skin on the vaccinee's hands, feet, arms, and legs began to peel. On 02/19/01, the right side of the vaccinee's face was swollen and the right eye was swollen shut. His mouth, lips, and tongue appeared "burnt". On 02/20/01, the vaccinee was seen by a physician in the ER. He was "injected with Prednisone", Given a prescription for Prednisone for three days, Benadryl every four to six hours as needed, and Hydrocortisone lotion as needed. The vaccinee's condition was unchanged in the morning of 02/21/01. At that time, the left side of the face, including the left ear, was swollen. The child was taken to another physician. He missed at the least one week of school because of the events. This report is considered incapacitating due to the school absence of greater than one week. As of 02/21/01, the outcome of the events is ongoing. Y N 02/07/2001 02/15/2001 8 OTH OTH NONE 20010051971 1
0166586 03/06/2001 CO 76.0 76 F 03/01/2001 Cellulitis in right arm, treated with antibiotics. Y 1 Y 01/18/2001 01/19/2001 1 CBC, CRP, Blood cultures. PVT UNK NONE NONE 1
0166588 03/06/2001 MI 0.2 0 .1 M 03/02/2001 On 8/30/00, on the date of his birth, the pt received his 1st Engerix-B. The pt was discharged from the hospital on approx. 9/8/00 and 1 week later, approx. 9/15/00, the pt developed an URI with fever of 101F to 102F (ear). The pt was seen by a pediatrician and was given unspecified antibiotic and liquid Tylenol. The URI resolved within 1 week. Two weeks later, approx. 10/1/00, the pt developed discoloration around his lips and mouth; a "few days" later, he developed petechia "all over". These symptoms resolved before 10/23/00. On 10/23/00, the pt received his 2nd dose of Engerix-B, DPT and IPV and within hours, post vax, the pt began to "cry all the time". The pt was seen twice by a pediatrician who made a dx of colic. The infant was then seen at a nearby clinic, due to colic and a swollen tongue. The colic was treated with hyoscyamine sulfate 2 to 4 drops every 6 hours. On 11/22/00, the pt went into respiratory arrest. He was taken by EMS to the local hospital, then transferred to a tertiary care center. The pt was hospitalized until 12/20/00 and, upon discharge, was placed in a foster home. The father was charged with shaken baby syndrome and the mother was charged with neglect. As of 2/26/01, the pt has "brain damage and is totally blind and deaf as a result of respiratory arrest." Y Y Y 25 Y U 10/23/2000 11/22/2000 30 OTH OTH Premature birth at 35 weeks 20010053791 1
0166590 03/06/2001 MI 0.2 0 .2 F 01/31/2001 Vomiting profusely and repeatedly which led to dehydration. Severe stress, apparently caused rectal prolapse. Y Y 1 Y 05/30/2000 05/30/2000 0 All tested normal on 5/30/00 and 6/1/00 PVT PVT NONE NONE 1
0166591 03/06/2001 WA 45.0 45 F 02/01/2001 Onset of severe vertigo with nystagmus on 3/12/98. Some "black holes" on MRI, initiated dx uncertain. Progression of symptoms over the next 2 years with some episodes of numbness and weakness and progression of MRI findings, including enhancing lesions led to dx of Multiple Sclerosis made in 2/00. Y N 02/19/1998 03/12/1998 21 MRI of brain-Demyelinating MIL MIL May have taken Echinacea NONE NONE 1
0166592 03/06/2001 MI 60.0 60 F 02/04/2001 High fever of 103F, vomiting, diarrhea and weak X 7 days. Y Y Y 11/15/2000 11/25/2000 10 NONE PVT PVT OGEN (ERT) NONE Codeine 1
0166593 03/06/2001 IN 2.0 2 .3 F 01/30/2001 On 1/10/01, came down with fever and pox. On 1/16/00, came to hospital ER with dehydration. On 1/17/01, was admitted until 1/19/01. Dx'd with pneumonia, lethargic, cellulitis and lack of coordination. Y Y 2 Y Y 01/04/2001 01/10/2001 6 CSF-showed no growth PUB PUB NONE NONE IN0012 1
0166594 03/06/2001 NJ 28.0 28 M 02/07/2001 Neurological Lyme Disease symptoms of headache, confusion, memory loss, visual difficulty, cognitive dysfunction, degenerated hand writing, "brain fog". Symptoms are because hasn't responded to antibiotic treatment; both oral and IV. In 4/00, I visited my optometrist for my vision problems and he prescribed reading glasses which did not solve my problems and as my symptoms progressed, I saw my PMD, 2 infectious disease specialists, a neurologist, an ophthalmologist and finally a rheumatologist. I was dx'd in 7/00 with Lyme disease. I am left with seemingly untreatable neurological symptoms that have robbed me of my ability to reason and filled my mind with never ending depression and hopelessness. Y Y N 07/17/1999 11/01/1999 107 Serologic Western Blot-positive; CT Scan-nml; MRI-nml; MRA-nml PVT PVT NONE NONE NONE 1
0166595 03/06/2001 GA 1.0 1 .0 F 02/06/2001 Was weak about 6 hours, post vax. Would not use right arm and had no muscle control; could not hold anything in right hand. Shot was given in legs. Y 01/29/2001 01/29/2001 0 NONE PVT PVT NONE NONE 1
0166596 03/06/2001 OH 1.4 1 .4 F 02/06/2001 Pt experienced 103F fever on 2/2/01 which quickly returned to normal. Blanchable, maculo-papular, measly looking rash which started on stomach on 2/4/01 and then proceeded to spread to arms, legs, back of neck and face on 2/6/01. Rash most pronounced on trunk, bilateral upper and lower extremities. These small circular lesions on palms and in diaper area. Also, soles of feet spared, currently. No strept exposure; lungs clear; nose clear discharge; minimal erythema in throat. Due to time course, it is questionable if related to MMR vaccine given on 1/24/01. Given Zyrtec for itching and rash. Otherwise, pt's activity and appetite are normal. Y 01/24/2001 02/02/2001 9 Rapid Strept-neg; Throat culture PVT OTH NONE NONE Right Otitis Media with perforation 1
0166597 03/06/2001 NC 0.5 0 .5 F 02/15/2001 Quarter-sized erythema at injection site. Seen 2 days, post vax. At 1 day, with reports at central site was "hard under the skin", but resolved in 24 hours. No fever. Y 02/13/2001 02/14/2001 1 NONE PVT PUB Cefzil, Kopeney Resolving BOM/WARI NONE 1
0166598 03/06/2001 MA 1.08 0 .9 M 01/29/2001 Mother's history; child developed generalized rash lasting 2 months after 1st dose of Prevnar; also a fever for 4-5 days; increase in mucus with gagging; sneezing every 2 minutes X 45 minutes. Seen and treated with antibiotic. She does not know dates. After 2nd dose of Prevnar on 1/5/01, child had 4-5 spots of rash on legs, back and arm; gone by 1/9/01 and no fever. PCP history; after 1st dose Prevnar; child seen on 10/26 and given Hep-B vaccine next seen on 10/30 for sore throat and cough was afebrile and dx'd pharyngitis. Siblings at home reported to be ill. On 11/5/00, child seen with fever of 104F, rash on inner thighs. Treated with Zithromax. On 11/6/00, seen at PCP; afebrile at 99F and non-toxic appearing. On 11/28/00, seen at PCP with rash on legs, arms, trunk and appeared to be clearing; dx'd ? viral rash. On 12/4/00, seen again at PCP and dx of rash made as Gianotti-Crosti Syndrome. On 1/5/01, seen PCP and rash cleared. 2nd dose of Prevnar given. Mother feels Prevnar was the cause of the child's symptoms despite being told by PCP this was not likely to be the cause. Mother called a number of places before reaching us and requested that the child's symptoms be reported. Y Y 10/10/2000 11/05/2000 26 Throat culture-neg on 10/30/00 OTH PUB NONE URI; Nasal congestion NONE 1
0166599 03/06/2001 NJ 3.0 3 M 01/27/2001 Swelling and redness on the lateral aspect of left arm about 4cm X 4.5cm. No tenderness with hard center. Y 01/25/2001 01/28/2001 3 UNK PUB 1
0166600 03/06/2001 VA 0.2 0 .2 M 01/31/2001 Hives within the first 24 hours, post vax. Parent did not call office so nothing was done. Subsided in 48 hours. Y 11/29/2000 11/29/2000 0 PVT PVT 1
0166601 03/06/2001 OR 1.2 1 .2 M 01/25/2001 Large urticarial area at site of Prevnar #1 and DTAP/HIB. No previous reaction to DTAP. Y 10/07/2000 10/07/2000 0 PVT PVT NONE 1
0166602 03/06/2001 MN 1.75 1 .7 F 01/31/2001 Barking cough, hoarseness, pale, weak, tired, stuffy nose and low-grade temperature. Y 01/05/2001 01/05/2001 0 NONE PVT UNK NONE NONE NONE Barking cough, hoarseness, pale, weak, tired, stuffy nose, low-grade temperature~Pneumo (Prevnar)~1~1.50~In Patient 1
0166603 03/06/2001 FL 0.5 0 .5 F 02/22/2001 The day following vax, pt presented with anterior fontanel full. No treatment indicated from results of CSF obtained. After 5 days, pt continued with fontanel full and CT of head was done with reading of negative study. Pt returned to office for recheck on 11/28/00 with full-fontanel resolved. Y 11/21/2000 11/22/2000 1 LP performed on 11/22/00-with CSF eval stat-no treatment indicated from results obtained. CT of head performed on 11/28/00 with full-fontanel resolved. PVT PVT 1
0166604 03/06/2001 AR 46.0 45 M No treatment. In January 2000, started experiencing pain in all joints. N 07/21/1999 04/20/2000 274 Tested Positive to HLA-DR4 genetic trait. Tested negative to ANA test. PVT OTH Valium 5mg, Lorcet Plus 2 herniated disc in back. 1
0166605 03/06/2001 OH 0.2 0 .2 M 02/14/2001 Temperature was 102F the evening of IZ, had high-pitched cry, difficult to console, poor feeding, not smiling or maintaining eye contact, seemed to be "spaced out" per dad. Seen in our office at 10:00 on 2/13/01 and temperature was 98.7 (R) and essentially normal exam. Y Y 02/09/2001 02/09/2001 0 NONE PVT PVT NONE NONE NONE 1
0166606 03/06/2001 TX 0.75 0 .8 M 02/12/2001 Rash over trunk and itching for approx. 20 minutes, post vax. Y 02/08/2001 02/08/2001 0 NONE PUB PUB NONE NONE NONE 1
0166607 03/06/2001 24.0 24 M 02/09/2001 Lump at site (quarter-sized) for 7 days. Headaches, blurred vision, loss of hearing in 1 ear, hips and knee aches. Had a bloody nose the next day and strange cysts or sores in mouth for about 7 days now. I could understand if it was 1 at a time but all at once had this, after shot. Y N 02/02/2001 02/02/2001 0 NONE MIL MIL Immunotherapy X 23 NONE Allergies 1
0166608 03/06/2001 OH 1.75 1 .8 M 02/19/2001 2-3 weeks, post vax, pt got a fever that lasted 2 days; maximum <103F and left cheek was swollen for 3 days. Y Y 01/25/2001 02/16/2001 22 WBC PVT PVT Constipation Speech delay 1
0166609 03/06/2001 CO 1.6 1 .6 F 02/23/2001 Temperature 99.6F (axillary); red rash at site and on feet and chest (maculo-papular); hot, hard, lump at site. Vomited x 2, last PM. U 02/21/2001 02/22/2001 1 PVT PVT Humatrope NONE Turner's Syndrome (Congenital Endocrine Anomaly) 1
0166611 03/06/2001 MD 0.5 0 .5 F 02/15/2001 2 hours, post vax, pt became quite fussy and for the next 12 hours was crying hard, constant, funny and occasional high-pitched scream. Y 02/12/2001 02/12/2001 0 PVT UNK NONE NONE 1
0166612 03/06/2001 FL 1.3 1 .2 F 02/09/2001 Received MMR, HIB & Prevnar on 2/2/01 and at that visit pt had otitis, conjunctivitis and a low-grade temperature. Pt informed, but 6 days later, developed sudden onset of high fever and seizure. Seen in office and found to have exudative pharyngitis. Y Y 02/02/2001 02/06/2001 4 PVT PVT Zithromax, Polytrim ophthalmide drops Conjunctivitis; otitis Allergy to Amoxil 1
0166613 03/06/2001 TX 0.5 0 .5 M 02/12/2001 On 2/10/01, pt developed a rash (maculo-papular), unspecific, apparently non-pruritic. Afebrile. No other symptoms or signs. Not on medication. On 2/12/01, viral syndrome. (Saw today in older sister; gastroenteritis). Y Y 02/07/2001 02/10/2001 3 CBC-lymphocytosis; blood culture-neg PVT PUB NONE NONE NONE 1
0166614 03/06/2001 WI 73.0 72 M 02/09/2001 Muscle weakness, hand weakness with swelling and joint pain for over a year. N 04/27/2000 Lyme test/Imugen PVT PVT Lipitor, captopril, Advil HBP; Diabetes; h/o DVT; Hyperlipidemia; stroke 1
0166615 03/06/2001 TN 0.5 0 .5 M 02/09/2001 Redness and swelling at site of right injections; 103.2F temperature. (5cm area of redness and swelling; surrounding both injections). Y U 02/08/2001 02/08/2001 0 NONE PVT PUB NONE NONE 1
0166616 03/06/2001 NJ 44.0 42 M 02/12/2001 Development of arthritis in both feet. Take Celebrex. U 04/30/1999 05/24/2000 390 X-rays and blood tests PVT PVT Allergies to pollen and shell fish 1
0166617 03/06/2001 OH 1.08 1 .1 F 02/14/2001 Febrile seizure; symptomatic treatment to keep fever down. Y Y 02/08/2001 02/08/2001 0 CXR-nml PVT PVT NONE NONE NONE 1
0166618 03/06/2001 WI 1.5 2 .1 M 02/02/2001 On 1/30/01, noted slight redness at injection site that was red x 4-5 days. No streaking. No drainage. Swelling at injection site noted on 2/1/01. No drainage. Swelling x 2-5 days. Symptoms resolved on their own. No clinic follow-up. Y 01/29/2001 01/30/2001 1 NONE PVT OTH NONE NONE NONE 1
0166619 03/06/2001 MI 4.0 4 M On 1/31/01 at 05:30, pt awoke with a fever of 104F and vomiting which continued. We went back to the doctor at 11:00 and he gave a prescription for Phenergan suppository. Vomiting stopped, controlled temperature with Tylenol and Motrin. On 2/1/01, diarrhea started and continued until the late evening of 2/4/01. Fever and diarrhea stopped on 2/5/01. Y Y 01/30/2001 01/31/2001 1 PVT PVT Flovent, Singulair, Nasonex NONE Asthma 1
0166620 03/06/2001 SC 4.0 4 M 02/05/2001 Right leg red and swollen. Instructed to give Tylenol and use warm compresses to area. Y 12/06/2000 12/12/2000 6 OTH PUB NONE NONE NONE 1
0166621 03/06/2001 SC 1.0 1 .0 F 02/05/2001 Both legs red and knots at injection sites. Instructed to give Tylenol and use warm compresses. Y 12/13/2000 12/14/2000 1 NONE OTH PUB Benadryl Cold symptoms NONE 1
0166622 03/06/2001 VA 0.3 0 .4 F 02/07/2001 Immunizations given on 12/6/00 at 4 month check-up. Pt had a screaming episode that evening that lasted 3 hours. Y 12/06/2000 12/06/2000 0 PVT PVT 1
0166623 03/06/2001 MD 1.25 1 .0 M 02/09/2001 Received MMR, VZV and Prevnar on 11/06/00 and was marked irritability for 10 days, post vax. No fever or treatment required. Y 11/06/2000 11/06/2000 0 NONE PVT PVT NONE NONE NONE 1
0166624 03/06/2001 HI 0.3 0 .4 F 01/30/2001 Fever X 5 days, then a rash which spread and resolved by day 7. Y 01/22/2001 NONE PVT PVT NONE NONE NONE 1
0166625 03/06/2001 CA 1.25 1 .3 M Mother describes hives as generalized over entire body approx. 5 hours, post vax. She gave Benadryl at that time. Mom denies that child had then or since, any symptoms of distress. Y 09/15/2000 09/15/2000 0 UNK PUB NONE NONE Umbilical hernia 1
0166626 03/06/2001 CA 0.5 0 .6 F 02/05/2001 Red and swollen hands, feet and legs by history (child was already ok when examined). Y 02/02/2001 02/03/2001 1 NONE MIL UNK Tylenol NONE NONE 1
0166627 03/06/2001 20.0 20 F 01/25/2001 Wheals on left inner aspect of arm (skin rash). Treated with antihistamine with resolution. Y 01/19/2001 01/22/2001 3 NONE MIL UNK Prevacid, Motrin, Claritin NONE NONE Local reaction~Anthrax (Biothrax)~2~20.00~In Patient 1
0166628 03/06/2001 FL 0.2 0 .2 M 02/09/2001 Generalized urticaria, acral edema and erythema. Y 02/07/2001 02/08/2001 1 NONE PVT PVT Tylenol infant drops NONE NONE 1
0166629 03/06/2001 NY 0.7 0 .7 F 02/07/2001 Swelling and pain on right thigh, post injection. Had a fever X 2 days. Use warm compresses. Y Y 02/01/2001 02/01/2001 0 PUB PUB NONE NONE NONE 1
0166630 03/06/2001 27.0 26 F 12/20/2000 Status post, 2nd Anthrax shot; had moderate local reaction with persistent 3cm X 3.5cm SC nodule. Y N 11/03/2000 11/04/2000 1 NONE MIL MIL NONE NONE NONE 1
0166631 03/06/2001 MO 1.02 1 .0 F 02/06/2001 Pt received IZ's on 11/16/00 and on 11/17/00, she started vomiting, was very fussy and not sleeping at night. On 11/30/00, she started running a fever of 100F to 101F. I gave her Tylenol to break the fever and I could not get her fever to break. On 12/1/00, around 10:30 AM, she let out a very high pitched scream and started staring into space and was very stiff and acted like she was trying to swallow her tongue. We called 911 and she was taken to the hospital. At the hospital her dx was febrile seizure. On 12/15/00, she started running another fever. which we gave her children's Tylenol and children's Motrin as directed by her physician, we could not get the fever to break and on 12/16/00 at 21:00 PM she started having another seizure and we called 911. She was taken to another hospital by EMS and all their tests came back as normal. From this hospital she was taken to the 1st hospital again by EMS. On 12/16/00, her dx was croup with febrile seizure. On 12/22/00, she was taken to a hospital for an EEG which was also normal. She has an appointment in the neurology clinic at the hospital on 4/10/01. Y U 11/16/2000 12/01/2000 15 CAT Scan; CXR; Urine tests, blood tests-all nml; EEG-nml PVT OTH NONE NONE NONE 1
0166632 03/06/2001 NJ 1.0 1 .0 M 02/07/2001 Fever of 103F for 2 days, 8 days, post vax. Rash developed 10 days, post vax. Y Y 01/25/2001 02/02/2001 8 PUB PUB NONE Asthma 1
0166633 03/06/2001 MO 1.5 1 .5 M 03/02/2001 Left thigh with very mild erythema; soft and without induration. Local injection site reaction. No treatment done. Y Y 02/20/2001 02/21/2001 1 PVT UNK Otitis Media 1
0166635 03/06/2001 AZ 2.0 2 .0 F 02/16/2001 On 2/14/01, pt had a febrile seizure and another on 2/15/01. Y Y 02/13/2001 02/14/2001 1 PVT PVT Was bitten by another child; URI 1
0166636 03/06/2001 VA 21.0 21 F 02/14/2001 Chronic severe itchy rash on arms, legs and trunk. Y 11/01/2000 MIL MIL NONE 1
0166637 03/06/2001 NE 1.3 1 .3 M 02/15/2001 Taken to ER at 17:45 on 2/13/01 with seizure which began 1 hour before that and lasted approx. 10 minutes. At daycare when seizure started. Had a temperature 102.3F, was P-140 and R-40. Dx'd febrile seizure. Y Y 02/13/2001 02/13/2001 0 CXR PVT PUB NONE Pneumonia 1 week prior to vaccinations; History of febrile seizures (3 previous episodes). 1
0166638 03/06/2001 NJ 0.2 0 .2 F 02/16/2001 Large local reaction with swelling over entire right thigh (hip to knee). Irritable with pain in left thigh and crying for 3 hours. Area not red or warm. Swelling subsided over 3-4 days, no obvious pain the next day. Treated with analgesics and ice packs. Y 02/07/2001 02/07/2001 0 PVT PVT NONE Congenital left hip dislocation 1
0166639 03/06/2001 PA 1.5 1 .5 F 02/09/2001 Local redness and induration (3cm in diameter) on right thigh. Y Y 02/06/2001 02/08/2001 2 NONE PVT PVT 1
0166640 03/06/2001 GA 0.8 0 .9 U 5 days, post vax, had a fever of 101.6F and diffuse urticaria. Treated with Benadryl. On day 6 and 7, fever was 101.6F with urticaria. Went to ER and was treated with Prelone and Atarax. Y N 02/08/2001 02/13/2001 5 NONE PUB PUB NONE NONE NONE 1
0166641 03/06/2001 RI 33.0 32 M 09/13/2000 Severe sinus symptoms without fever; severe flushing; severe back and knee pain; severe joint pain and swelling; twitching of muscles (uncontrollably); severe weakness (has been in bed since); severe dizziness; numbness of face and arm; chest pain with tingling. Y U 08/20/1999 08/01/2000 347 Lyme test; CBC; triglycerides, etc PVT PVT Pain medicine; Vicodin; Soma Sinusitis; dizziness NONE 1
0166642 03/06/2001 MD 38.0 37 M 02/11/2001 The pt experienced urticaria. Y U 02/10/2001 02/10/2001 0 MIL MIL NONE NONE 1
0166643 03/06/2001 MA 71.0 79 F The pt developed swelling, erythema and pain at the injection site. Y 10/23/2000 10/25/2000 2 NONE PVT UNK NONE CAD, s/p stent placement, elevated cholesterol, HTN, urinary incontinence 1
0166644 03/06/2001 VA 7.0 7 M 02/19/2001 One week post vax, the pt experienced hives. U 01/08/2001 01/16/2001 8 PVT UNK 1
0166645 03/06/2001 MN 26.0 26 F 02/04/2001 The pt felt nausea one hour post vax, joints began to get stiff and there is a tingling in the throat when breathing. Hot flashes, increased heart rate, and shortness of breath. U 02/04/2001 02/04/2001 0 MIL MIL NONE NONE NONE 1
0166646 03/06/2001 PA 47.0 47 F 01/31/2001 The pt experienced severe weakness, coughing, fever, chills. The pt required antibiotics. Y 11/13/2000 11/13/2000 0 PUB OTH NONE esophageal reflux, asthma, diabetes, allergy to sulpha, PCN 1
0166647 03/06/2001 MN 1.0 1 .1 M 02/06/2001 The pt experienced erythema multiforme which started approximately 1 week post vax. Started with an urticarial rash, progressed to erythema multiforme with extreme swelling. Y Y 01/22/2001 01/30/2001 8 PVT PVT Augmentin ear infection NONE 1
0166648 03/06/2001 MO 66.0 66 M 02/02/2001 The pt experienced aching in the left arm, migrating from the wrist to forearm to the elbow and shoulder five days post vax. Seen by a physician on 1/23/01. The pt was prescribed Neurotin. Y Y 12/12/2000 12/17/2000 5 PUB PUB Micronase, Glucophage NONE diabetes, hay fever 1
0166649 03/06/2001 CA 27.0 27 F 01/26/2001 The pt experienced a rash covering entire body, itching, complained of feeling cold. Treated with Benadryl. Temp - 97.2, Pulse - 88, Respirations - 20, blood pressure - 120/80 Y U 01/26/2001 01/26/2001 0 NONE MIL MIL Synthroid NOEN allergy to sulfa, ASA 1
0166650 03/06/2001 WI 52.0 52 F 02/12/2001 The pt experienced a rash and pruritis. The rash started on upper back and abdomen, chest and arms. MD thought it may be reaction to flu shot. Y 12/04/2000 NONE PUB PVT Prozac, Pneumarine NONE NONE 1
0166651 03/06/2001 MO 49.0 49 F 01/10/2001 Three days post vax, the pt experienced swelling, redness, and pain, from elbow to shoulder. Treated with Ibuprofen and ice for swelling. Incident resolved by the time it was reported. Y 12/22/2000 12/25/2000 3 NONE PUB PVT NONE NONE 1
0166652 03/06/2001 ND 31.0 31 F 02/05/2001 The pt experienced pain in the left arm, achiness all over, fever, chills, nausea and headache. Used analgesics and ice to the affected area. Had allot of pain for 3 days and then it lessened. The pt also experienced a hard lump at the site and a few red blotches on the left arm. Y Y 01/18/2001 01/19/2001 1 PVT OTH NONE NONE 1
0166653 03/06/2001 26.0 26 F 12/07/2000 The pt experienced flushing, dizziness, nausea 10 minutes post vax. Treated with epinephrine. Symptoms resolved within 15 minutes. Y Y 12/07/2000 12/07/2000 0 NONE MIL MIL Depo Provera NONE allergy to morphine, lortab, Benadryl 1
0166654 03/06/2001 CO 43.0 43 F 03/01/2001 The pt experienced body aches, fever, and malaise. Y 10/04/2000 10/05/2000 1 PVT PVT NONE NONE NONE 1
0166655 03/06/2001 CO 42.0 42 F 03/01/2001 The pt experienced a fever, body aches, swollen sore glands, malaise. Y 02/05/2001 02/06/2001 1 PVT PVT NONE NONE NONE 1
0166656 03/06/2001 CO 37.0 37 F 03/01/2001 The pt experienced pain and swelling of arm on the same day as vax. The next day the pt experienced increased pain and swelling, Redness began to occur and extended down to the elbow. Y Y 02/09/2001 02/09/2001 0 NONE PUB UNK NONE NONE NONE 1
0166657 03/06/2001 VA 4.0 5 F 03/01/2001 The pt experienced ITP on 2/20/01. Y 02/01/2001 02/18/2001 17 platelets - 4,000, WBC - 10.5 UNK UNK NONE URI NONE 1
0166658 03/06/2001 VA 1.5 1 .5 F 03/01/2001 The pt experienced a 6.5cm x 8.5 cm raised erythematous lesion on left thigh at injection site. The pt was treated with oral antibiotics for possible cellulitis. U 02/27/2001 02/27/2001 0 PVT PUB NONE hx of pneumonia 1
0166659 03/06/2001 MA 6.0 2 .1 F 02/21/2001 6 year old white female presents with temperature 101F-102F and spots, itching, starting on chest and back. Exposed to chickenpox, 1 week ago. Had vaccine 8/27/96. Discharged with 20 red spots 1mm X 1mm, 2mm X2mm vesicles on trunk and back, 1-2 on arms and legs approx. and 1 in vagina, itching. It is too early to tell. Y U 08/27/1996 02/19/2001 1637 PVT PVT NONE NONE 1
0166660 03/06/2001 MA 2.0 2 .1 F 02/20/2001 Chickenpox (mild case) began on 2/16/00 after being exposure in this vaccinated pt. Had about 30 maculo-papular lesions on trunk, scalp and labia. Y 03/24/1999 02/16/2001 695 PVT PUB NONE 1
0166661 03/06/2001 TX 32.0 31 M 02/15/2001 Developed rash on right arm and abdomen, 1 day, post vax. Y 01/17/2001 01/25/2001 8 NONE PUB PUB Albuterol oral inhaler NONE Asthma 1
0166662 03/06/2001 SD 4.0 1 .3 F 02/12/2001 Right thumb with herpes zoster eruption. U 11/24/1997 02/02/2001 1166 PVT PVT NONE 1
0166663 03/06/2001 NY 15.0 13 M 02/19/2001 Local reaction; fatigue; weak; headache; fever and malaise per mom on 9/18/1998. Y 03/20/1998 09/18/1998 182 PVT UNK Bilateral otalgia Seasonal allergies 1
0166664 03/06/2001 NY 17.0 17 F 02/19/2001 Some erythema with some nodularity beneath it that was mildly tender to palpation. Y 10/17/2000 10/18/2000 1 PVT UNK 1
0166665 03/06/2001 NY 21.0 17 M 02/19/2001 On 9/18/98, mom called and said pt was weak, fatigued with a headache, fever and malaise. Y 03/20/1998 09/18/1998 182 PVT UNK Resolved OM; Seasonal allergies, megalocornea 1
0166666 03/06/2001 TX 4.0 4 M 02/22/2001 24 hours, post vax, had swelling, redness, heat and hardness to left upper arm extending from outer arm (mid) up to shoulder and under arm to mid upper arm. Y 02/21/2001 02/22/2001 1 PUB UNK 1
0166667 03/06/2001 OR 4.0 4 M 02/20/2001 Fever, lymphadenopathy, parotid gland enlargement on right, 17 days, post vax. Treated with Advil, Tylenol per PNP. On 2/6/01, improving with no other problems. Y Y 01/18/2001 02/04/2001 17 NONE PUB PUB NONE NONE 1
0166668 03/06/2001 IL 1.0 2 .0 F 02/12/2001 2" area surrounding injection site of redness and warmth. Y 01/25/2001 01/26/2001 1 PVT PVT NONE NONE 1
0166669 03/06/2001 IL 5.0 5 M 02/09/2001 On 10/11/00, pt received vaccines and developed erythema and subsequent desquamation on all extremities. Also had fever, nausea and vomiting for several days. Y Y 10/11/2000 10/11/2000 0 PVT PVT NONE NONE NONE 1
0166670 03/06/2001 IL 6.0 6 M 02/09/2001 On 1/8/01, pt received vaccines and developed erythema of extremities and subsequently, desquamation of extremities, distally. Had similar reaction with last set of IZ's. DTAP was the only vaccine in common. Y Y 01/08/2001 01/08/2001 0 PVT PVT NONE NONE NONE Desquamation~DTaP (no brand name)~2~5.00~In Patient 1
0166671 03/06/2001 VA 4.0 4 M 02/13/2001 IZ reaction on 1/31/01. Upper arm swollen 11cm X 11cm on 2/2/01. No pain at site. Received Claritin 1 1/2 tsp every day. No further complaints with next doctor's visit on 2/12/01. Y 01/31/2001 02/01/2001 1 NONE PVT PVT NONE Chronic abdominal pain especially after eating. 1
0166672 03/06/2001 CO 3.0 2 .1 M 02/07/2001 Large erythematous local reaction with induration measuring 15cm X 20cm. Y Y 02/05/2001 02/05/2001 0 NONE PUB UNK NONE NONE 1
0166673 03/06/2001 SC 52.0 F 02/01/2001 One day post vax, the pt complained of swelling of arm. Y 01/19/2001 01/20/2001 1 OTH OTH NONE NONE NONE 1
0166674 03/06/2001 AK 5.0 4 F The pt experienced a warm painful, swollen, red spot at the injection site about an inch in diameter, no where else on the body and left a bruise after a week of symptoms. Y 11/29/2000 12/12/2000 13 PUB PUB 1
0166675 03/06/2001 AK 5.0 4 F The pt experienced a painful, warm, swollen, red spot at the injection site which was an inch in diameter and then a bruise after a week of the symptoms. Y 11/29/2000 12/12/2000 13 PVT PUB 1
0166676 03/07/2001 AK 5.0 5 F 01/12/2001 This patient had a warm, painful, swollen, red spot right at the injection site about an inch in diameter, no where else on body, left a bruise after a week of symptoms. Y 11/29/2000 12/13/2000 14 PVT PUB NONE 1
0166677 03/07/2001 NY 46.0 45 F 02/02/2001 This patient remained home on 01/31/2001 after receiving vaccine on 01/30/2001. Complained of left deltoid pain, feverish / chills. Treatment was Tylenol, Ice, and ROM. No SOB, no chest pain, no rash, no headache. Y 01/30/2001 01/31/2001 1 PVT PVT Allergies to Sulfa, ASA, PON. 1
0166678 03/07/2001 NE 31.0 31 F 02/01/2001 Injection site became swollen to baseball size, firm and very tender to touch. Patient denied redness or warmth to the site. Y 01/15/2001 01/16/2001 1 NONE PVT PVT Vitamins, Lodine XL. Fell down the stairs. NONE 1
0166679 03/07/2001 MI 11.0 11 F 11/06/2000 This patient had a generalized varicella-like rash, maculo-papular, approximately 20 lesions. The first lesion was on the dorsal side of the foot and was fluid-filled. No treatments. Lesions covered to prevent spread of vaccine virus. Y 10/16/2000 11/03/2000 18 PUB PUB NONE NONE 1
0166680 03/07/2001 MI 33.0 33 F 12/04/2000 This patient had a local reaction, pain, swelling, erythema, large area of upper arm, affected strength and ROM, and numbness persisted over 48 hours. Treatment was Ibuprofen, cold compresses, diphenhydramine HCL; also had systematic reaction, myalgia, and arthralgia. Y 11/14/2000 11/14/2000 0 PUB PVT NONE Had pneumococcal pneumonia 05/00. 1
0166681 03/07/2001 CA 1.4 1 .3 M 11/12/2000 A few hours after treatment this child was crying a lot, and uncomfortable. Woke up a few times more that night. She felt warm to the touch. He was uncomfortable. About 2-3 days after that he was not looking at his parent when she called his name and this strange behavior continued. The patient lost all eye contact, and did not say anymore words. Y N 08/15/1982 08/15/1982 0 NONE PVT PVT NONE NONE 1
0166682 03/07/2001 FL 53.0 53 M 01/31/2001 This patient had swelling and pain of the left deltoid on 01/31/2001. Treatment with Benadryl and Prednisone. Y 01/30/2001 01/31/2001 1 NONE PUB PUB Avadia, Humilin 70/30. NONE Diabetes, Allergy to Aspirin. 1
0166683 03/07/2001 TX 0.3 0 .3 F 01/31/2001 This baby had to be woken up, glazed eyes, high pitched inconsolable screaming, sleepy, no appetite. Y Y 01/29/2001 01/30/2001 1 NONE PVT PVT NONE NONE NONE 1
0166684 03/07/2001 PA 1.6 1 .6 M 01/31/2001 This patient had redness and swelling on the right arm at the injection site on 01/30/01. On 01/31/01, his right arm was swollen, past 29 degrees at Trihibit site. Itching, but no fever. Swelling and patchy erythema on the right upper arm with excoriation. Slight soft swelling at the Prevnar site, well perfused distally. U 01/29/2001 01/30/2001 1 PVT PVT Cough, Asthma. 1
0166685 03/07/2001 NH 9.0 9 F 02/01/2001 This patient had pain of the right arm consistent with reflex sympathetic dystrophy, onset within hours of shot. Course expected to be prolonged. Prescription: Analgesics, including narcotics, Neuroleptics. Ongoing patient needed. Evaluation at tertiary care center. Y U 01/17/2001 01/17/2001 0 X-ray - Nml. PVT PUB 1
0166686 03/07/2001 KY 0.5 0 .6 F 01/31/2001 Per the PC at the clinic, the patient had shots there on 01/08/01 and on 01/09/01. It looked like mosquito bites (raised whelps) around the injection sites , then she developed a rash around the injection sites on both legs (upper thighs) with knots noted at the injection sites. Y Y 01/08/2001 01/09/2001 1 NONE PUB PUB NONE NONE NONE 1
0166687 03/07/2001 IL 1.0 1 .0 M 02/07/2001 At 6 PM this infant had a spike fever of 102.5 F then it went to 104.5, he vomited, and became disoriented. His fever went down with Motrin. He had a fever on and off for a total of 5 days, then he had a viral rash. Doing well now. Y 01/30/2001 01/30/2001 0 PVT PVT NONE NONE NONE ~DTP (no brand name)~2~0.30~In Sibling 1
0166688 03/07/2001 CO 16.0 16 F 01/23/2001 This patient developed a rash 24 hours after the vaccination of Hep B #1. The rash appears to be erythema multiforme. No other complaints. She was treated with Atarax. Y 01/20/2001 01/21/2001 1 NONE PVT PUB Allegan, Amoxicillin. NONE NONE 1
0166689 03/07/2001 OH 1.0 1 .1 M 01/29/2001 Seen in the ER for a fever or 101 (R), low fluid intake, diarrhea. Y U 01/04/2001 01/07/2001 3 CXR PUB PUB NONE NONE NONE 1
0166690 03/07/2001 RI 39.0 39 F 01/29/2001 On 07/31/00, this patient had 50 mm erythematous, edematous at the injection site. Slight induration, (+) heat. For induration advised to apply Triamcinalone cream. On 08/02/00, the patient had fever, chills; the PCP gave Cefadroxil. On 08/04/00, advised to apply ice for 10-15 minutes to 40 mm induration. On 08/07/00, resolving, induration down to 15 - 20 mm. Y Y 07/20/2000 07/31/2000 11 07/15/00 Rubeola FGG Ab was in Neg range necessity, Rubeola vaccine. PUB PVT Left ovarian cyst. 1
0166691 03/07/2001 CA 42.0 42 F 01/29/2001 This patient had a TD given in her right deltoid on 01/26/01. On 01/27/01, the next day, the patient complained of redness and pain to the site. Presented 01/29/01 with swollen, red area on the left site 70 mm x 80 mm. Per the doctor the patient was allergic to the vaccine. Y Y 01/26/2001 01/27/2001 1 PVT PVT NONE NONE 1
0166692 03/07/2001 AR 1.4 1 .5 M 01/29/2001 This child has redness and swelling of the right thigh where the DTaP was given. Y 01/24/2001 01/26/2001 2 PVT PUB 1
0166693 03/07/2001 PA 0 .0 M 12/18/2000 This new born was given a Hep B vaccine on 11/30/00, and a duplicate dose on 12/01/00. No adverse symptoms. Y 12/01/2000 PVT OTH NONE NONE 1
0166694 03/07/2001 OR 24.0 24 F 01/25/2001 This patient had an increased heartbeat 2:00 - 4:00, nausea 2:00 - 10:00 PM, dizziness 2:00 - 10:00 PM most severe 5:00 PM to 10:00, and hot flashes 2:00 PM - 10:00 AM, on 01/25/01. Y 01/24/2001 01/24/2001 0 NONE MIL PVT Mantoux TB, Connaught, lot # C0519AA, left forearm, 01/12/01 and 01/24/01. Thalasymia 1
0166695 03/07/2001 DC 6.0 1 .3 M 01/30/2001 This child was diagnosed with shingles 01/26/01. Y Y 09/11/1995 01/26/2001 1964 NONE PVT PVT NONE NONE NONE 1
0166696 03/07/2001 MI 15.0 15 F 01/18/2001 This patient had urticaria, lip swelling, hand and feet swelling, approximately 1 hour after administration of her vaccinations. Y Y 01/15/2001 NONE PVT PUB NONE Mild Asthma 1
0166697 03/07/2001 KY 4.0 4 M This child had complained of itching, redness, and swelling in a 3-4" diameter, last PM. Noticed at 7 PM. Has resolved 01/29/01. Y 01/23/2001 01/24/2001 1 PUB UNK NONE NONE NONE 1
0166698 03/07/2001 MS 4.0 1 .6 F 02/15/2001 This patient broke out with mild case of chicken pox- unverified by the doctor 01/01. Received varicella 10/09/97. Y 10/09/1997 PUB PUB 1
0166699 03/07/2001 NJ 1.5 1 .3 M 02/23/2001 On 01/14/01, this patient presented with an elevated temp of 106 at home with seizure activity, stated the parent. They called EMT, who transported the patient to the ER. Per ER report, the child with elevated temp of 102.5 at 22:40 on 01/14/01. Primary diagnosis was left otitis media. Prescribed Amoxicillin and Tylenol, and discharged home. Y Y 01/04/2001 01/14/2001 10 CBC , Blood and Throat culture. PVT PVT NONE NONE NONE 1
0166700 03/07/2001 MI 58.0 58 F 02/21/2001 This patient received TD and Hep A on 07/05/00, at her county health dept. She called them to report "severe flu-like symptoms" that evening. She was told it was like due to the TD. The patient received her 2nd Hep A vaccine on 02/07/01 at another county health dept. Within in hours she developed "worse state of depression she's ever had", also complained of weakness, shaking, and dropping things. She developed a hoarse voice which she still has. The patient walked into the Health dept today to report all of this, she did not call there or her private physician. Y 02/07/2001 02/07/2001 0 PUB PVT Patient states she is on several meds including antidepressant. 1
0166701 03/07/2001 KS 22.0 22 F This patient had Varivax on 01/26/01. She thinks she has varicella now. Rash. On 02/20/01 a few lesions, more lesions on 02/21/01, lesions on her back, and back of her thighs, one on her abdomen. None on her face, or neck. Itch. No new lesions on 02/22/01. One was scratched and is now crusted. To see private MD for diagnosis. None on her scalp. U 01/26/2001 02/20/2001 25 PUB PVT NONE NONE NONE 1
0166702 03/07/2001 TX 5.0 5 F 02/08/2001 This child had immunizations on 01/29/01, hives developed on 01/30/01. Y 01/29/2001 01/30/2001 1 NONE PVT PVT Zithromax Sinusitis NONE 1
0166703 03/07/2001 NJ 42.0 42 F One day after her vaccine the patient reported a high fever. Y 02/06/2001 02/07/2001 1 NONE PVT UNK NONE NONE 1
0166704 03/07/2001 DE 11.0 11 F 02/01/2001 Within 20 minutes from the time of this patient's shot, a rash broke out on her neck. The following day the rash is still on her face. No difficulty breathing or wheezing. Y Y 01/31/2001 01/31/2001 0 MIL UNK NONE NONE 1
0166705 03/07/2001 MA 35.0 35 F 01/29/2001 2 to 3 days after the patient received her vaccine, she developed a rash on her chest and limbs. The rash was red, and itchy. No respiratory sickness. Localized slowly resolving rash. Y 01/03/2001 01/05/2001 2 NONE PVT UNK PPD, 01/03/01. NONE NONE 1
0166706 03/07/2001 DC 1.2 1 .1 F 01/31/2001 This patient had a raised rash on back and abdomen, puffiness and redness around both eyes. Y 01/15/2001 01/15/2001 0 NONE OTH PUB Bactrim no acute illness Reflux - partial Nephrectomy. 1
0166707 03/07/2001 OH 29.0 29 F 02/05/2001 This patient had a 16 x 5 1/2 " induration and redness at the injection site on her left arm, arthralgia left shoulder and arm. Prescribed Prednisone. Y 01/26/2001 01/27/2001 1 PUB PVT NONE NONE NONE 1
0166708 03/07/2001 KS 0.2 0 .2 F This infant began vomiting 18 hours after her immunization. She was taken to the doctor, stated possibly due to the shots. The mother called the doctor on 01/30/01 with complaints of continued vomiting. The doctor said now it's probably not due to the vaccines and watch child with next vaccines. No temp, no rash. Diarrhea started 01/31/01. N 01/23/2001 01/24/2001 1 PUB PUB NONE NONE NONE 1
0166709 03/07/2001 WA 11.0 11 F 01/18/2001 This child had joint pain occurring within 24 hours after being vaccinated. Intermittent joint pain lasting 2 1/2 months. Treated with Tylenol. Y 08/21/2000 08/22/2000 1 PUB PUB NONE NONE NONE 1
0166710 03/07/2001 NV 5.0 5 F 01/31/2001 This child, complained of pain in less than a few hour hours after her shot. She won't move her shoulder, no fever. Her shoulder has 7 x 6 inch red, tender, swollen area. Y 01/29/2001 01/29/2001 0 NONE PVT PUB 1
0166711 03/07/2001 CT 11.0 11 M 02/01/2001 This child had red, swollen eyes, weakness, erythematous skin, questionable difficulty breathing, and a rash. Y Y 01/30/2001 01/30/2001 0 PVT PUB Dextrostat NONE ADHD Hives~Varicella (Varivax)~1~8.00~In Patient 1
0166712 03/07/2001 KS 44.0 44 F 02/05/2001 This patient had a itchy, red, sore left arm, and an upset stomach. Y 02/03/2001 02/04/2001 1 MIL MIL PPD, Connaught, lot #C)520BA, ID left arm, 2 previous doses, 02/03/01. End of a cold. NONE 1
0166713 03/07/2001 GA 1.0 1 .0 M 01/04/2001 This infant had erythematous papular rash, some confluence, over the right deltoid lateral thigh only. U 11/30/2000 12/29/2000 29 NONE PVT PUB Biaxin Otitis media NONE 1
0166714 03/07/2001 TX 33.0 33 M 01/31/2001 This patient had a rash and itching on his neck and trunk. The patient took Benadryl for 3 days. Y 01/19/2001 01/19/2001 0 NONE OTH PUB Anti-inflammatory medication. Sinus infection Allergic to Toradol, Codeine, flu shot. 1
0166715 03/07/2001 GA 1.2 1 .2 F 01/30/2001 This patient had papular rash on her face, neck, chest, abdomen. No treatment . U 01/19/2001 01/21/2001 2 PVT PUB NONE NONE NONE 1
0166716 03/07/2001 NY 53.0 53 M 02/01/2001 Patient received immunizations on 01/29/01, one day after the patient developed swelling, redness, and pain at the injection site (left deltoid). U 01/29/2001 01/30/2001 1 NONE PUB PUB NONE NONE NONE 1
0166717 03/07/2001 CA 9.0 9 M 02/05/2001 The patient was administered 1 shot of Hep B, 3rd in a series. The patient fainted onto the floor immediately went into seizure activity for less than 1 minute, no incontinence, vital signs stable immediately afterwards. Y 02/05/2001 02/05/2001 0 OTH PUB NONE NONE NONE 1
0166718 03/07/2001 PA 1.5 1 .5 M 02/06/2001 This child had a red, swollen quarter sized area on his left up per arm at the injection site. U 01/29/2001 01/30/2001 1 NONE PVT PVT NONE NONE NONE 1
0166719 03/07/2001 CA 49.0 49 F 02/05/2001 This patient had acute pain to neck, wrists, and knees. She has had prior surgery to her knees. Also experienced joint pain and swelling. N 01/05/2001 01/12/2001 7 Diagnostic Labs PVT PVT NONE Previous knee surgery. 1
0166720 03/07/2001 NY 12.0 12 M 02/19/2001 Per mother, this patient had a fever, triggered asthma attack. The child missed several days of school. Y 09/18/2000 09/19/2000 1 PVT PVT NONE Asthma 1
0166721 03/07/2001 SC 1.6 1 .6 M 11/10/2000 No data provided. Y 11/09/2000 11/10/2000 1 PVT UNK NONE 1
0166722 03/07/2001 IL 1.2 0 1 M 02/13/2001 This child had a fever up to 104.2 (ax), eight days following his vaccination, loss of appetite, irritability, lethargy, rash with itching on the 11th day following the vaccine. Treatment after visit to the pediatrician was Advil and Tylenol for the fever, and alot of fluids. Y Y 11/08/2000 11/16/2000 8 NONE PUB UNK NONE NONE NONE 1
0166723 03/07/2001 CO 1.2 0 .2 M 06/30/2000 This child had extreme eczema on his face, entire body oozy and bloody from 2 month. Still has some now at 14 month, but almost clear. Used alternatives and breast milk, special baths, ointments, and creams. Now has asthma. not completely recovered. Y N 06/23/1999 07/02/1999 9 PUB OTH 1
0166724 03/08/2001 NM 0.5 0 .5 M 02/26/2001 The pt was found unresponsive/apneic by parents around 4:00pm on 2/10/01. The pt was transported to the ER. The pt died in the ER. Y 02/10/2001 N 02/09/2001 02/10/2001 1 MIL MIL oral Decadron, inhaled albuterol BPD - chronic bronchopulmonary dysplasia, 28 week premature infant 1
0166725 03/08/2001 WA 4.0 4 F 02/05/2001 The child had an undiagnosed metabolic/endocrine problem had gradual deterioration in the last few months of life. A week before death the pt had a "strange" breathing pattern, like gasping. Died 15 days post vax. PMD does not think it is causally related. Sudden death, no fever. Y 01/22/2001 N 01/08/2001 01/22/2001 14 NONE PVT PVT Ranitidine, Fluoride, Prednisone, Reglan, multivitamins NONE microcephaly, undiagnosed endocrine abnormality, GE reflux, G-tube fed WA011712 1
0166730 03/08/2001 MT 39.0 39 M 02/28/2001 Information has been received from an RN concerning a 39 year old white male who on 1/23/01 at 09:00, was vaccinated with Hep-B, IM, in the LA (1047J). On 1/23/01, at 14:00, the pt experienced shakiness, dizziness, general weakness, warm feeling, a BP of 140/84, lethargic, pulse tachy and pale. The pt was seen at the health dept and encouraged to drink lots of fluids and rest. The symptoms continued until bedtime that day. The pt was able to sleep. Subsequently, the next morning, the pt awakened feeling "ok". The pt's symptoms resolved on 1/24/01. The pt's experiences were considered to be disabling. No further information is expected. Y Y Y 01/23/2001 01/23/2001 0 PUB PVT Celexa Hepatitis C WAES01012088 1
0166731 03/08/2001 WA 0.2 0 .1 M 02/26/2001 Fever, lethargic; evaluated at ER and admitted. Y 2 Y 01/30/2001 02/20/2001 21 Blood Culture; CSF Culture; Urine Culture-neg (final report) PVT PUB NONE NONE WA011711 1
0166732 03/08/2001 WA 75.0 75 F 01/30/2001 1 day, post vax, very weak and unable to get out of bed for 3 days. No appetite to eat or drink. Felt "dreadful" but able to get up off and on. Saw MD on Wednesday. Went to hospital. BP 80/50 for 2 days. Went home after rehydration. Home overnight and then to ER. She was admitted to hospital for 4 days, for tests. She was dx'd with Guillain-Barre Syndrome and discharged. She had no further progression of the neuropathy. Y 4 Y 10/18/2000 10/19/2000 1 EKG; Spinal Tap; Blood work PVT PVT HCTZ, Zestril, Potassium, Norvasc, ASA NONE Arthritis WA011714 1
0166733 03/08/2001 GA 73.0 73 F Pain in legs, beginning 10 days or so, post vax. Gradually becoming worse; unbearable by mid November; feet numb; no paralysis. Treated with prednisone and Neurontin. Diagnosed with autoimmune peripheral neuropathy. Doc 212685, annual follow up states that patient has numb feet and problem with balance. Follow up 06/20/2001: "Patient has not recovered from adverse event. 1981: Hypothyroidism, prescribed Syntroid-stable. Patient did not receive any prior similar conditions before this adverse event. Other immunizations for influenza was 10/19/1999. Final diagnosis if GBS has not been made. Diagnosis changed from GBS to chronic inflammatory demyelinating polyneuropathy after biopsy. Consents for release of medical records and hospital discharge summary will be signed and returned to VAERS." Y 4 N 10/04/2000 10/14/2000 10 EMG PUB PVT Synthroid, hormones NONE Contact allergies 1
0166734 03/08/2001 MS 1.25 1 .3 M 01/12/2001 Severe, profound and permanent pervasive developmental disorder, language delay and autism. Immediately after shot, he started running very high fever, became very quiet and appeared to be confused. Y N 10/08/1997 10/09/1997 1 PUB UNK 1
0166735 03/08/2001 NJ 18.0 18 F 03/01/2001 Notified by parent on 2/26/01 that on 1/12/01, daughter admitted to hospital after found unconscious at home. Lyme and MS ruled out by Neuro MD. Dx'd with ADEM related to pt receiving flu vaccine. Abnormal gait; incontinence and no short term memory. Y Y 9 Y Y N 12/08/2000 01/12/2001 35 Lyme disease and MS ruled out. MRI-abnormal OTH OTH NONE NONE High cholesterol,hypertension, hypercholesterolemia 1
0166736 03/08/2001 FL 0.25 0 .3 F 02/27/2001 Apnea, seizures, 48 hours, post vax. May need anti-convulsants. Awaiting more testing and reports. Pt is a 4 month old girl referred because of recent spells uncertain origin. History was obtained from the pt's parents. Medical records was also reviewed. She received multiple immunizations including DTaP, inactivated polio, and HIB 02/20/2001. Over the next few days, she may have had a few episodes in which she dropped off to sleep more rapidly than usual: however, these incidents were not of great concern to the parents or grandparents. The patient was afebrile. Four days after her immunizations, she had a brief dusky spell which was associated with apparent alteration consciousness. She became pale and there was perioral cyanosis. She appeared to suck on her lower lip. The pupils were dilated. She started vacantly and was minimally responsive. Parents describe a "distant look." Toward the end of the brief episode, she bacame limp and soon thereafter she slept. She was admitted to hospital where additional, similar episodes occurred. Similar spells occurred in greater number in the second hospital day. On the third hospital day she had only 2 episodes, and there have been non subsequently. Parents state that the pt's personality and behavior changed during her illness in that she was less social and vocal for several days: however, these changes have not persisted, and the pt has returned to her premorbid level of functioning. As noted above, the pt has not been frbrile. There have been no convulsive episodes. Although perioral cyanosis was observed and the question of apnea was raised, no apnea or bradycardia was documented when the pt was monitored during the episode that occurred in hospital. An EEG was normal. MRI scan of the head showed a small cyst in the right choroidal fissure (adjacent to the mesial temporal lobe). The films are not available for review. No associated change in the signal intensity of the temporal lobe is mentioned in the report. Prominent frontal CSF spaces were also noted, and the radiologist raised the possibility of atrophy. The parents major concern revolves around the question of barin atrophy. A lumbar puncture was not performed Y Y 4 Y 02/20/2001 02/22/2001 2 EEG; MRI; CBC; EKG PVT PVT NONE NONE 1
0166737 03/08/2001 GA F Body aching, neck pain, headache treated with Motrin. I believe vaccinated in 1979-1980. Y N MIL MIL NONE NONE NONE 1
0166738 03/08/2001 HI 0.3 0 .3 M 01/09/2001 At 2 months, received DTAP and pt had severe fussiness for 2 hours. Discussed holding pertussis but parent declined. Pt had a new onset a febrile seizure. Y 1 Y 01/04/2001 01/05/2001 1 PVT PVT NONE NONE 1
0166739 03/08/2001 VA 1.0 1 .1 F 02/23/2001 Vaccines given that morning and by that evening has a slight fever. Then had prolonged seizure (15-20 minutes). Transported from local hospital to PICU at another hospital due to prolonged postictal state and hypoventilation. Y Y 1 Y 02/15/2001 02/15/2001 0 EEG on 2/17/01-normal PVT PUB NONE NONE Recurrent otitis media, sinusitis 1
0166740 03/08/2001 PA 1.25 1 .3 M 02/23/2001 Pt received Prevnar and MMR II in office. Family left office and noted that pt was not responsive and was red all over. Brought to ER, hypotensive and unresponsive. Responded to fluids, epinephrine and Benadryl IV. Diagnosed with servere reaction to vaccine. Y Y 2 Y 02/21/2001 02/21/2001 0 CBC, EEG-wnl PVT PVT NONE NONE Born with bilateral club feet, requiring surgery 1
0166741 03/08/2001 WA 43.0 43 F 12/12/2000 Left eye blurry vision and left eye deviation (intermittent); feels "queezy" and dizzy with diplopia. This began about 02:00 and continued on this morning. Resolved in about 24 hours. Y Y 1 Y 11/15/2000 11/16/2000 1 MRI; CT; Carotid Doppler and all blood tests-wnl PVT PVT NONE NONE NONE WA011729 1
0166742 03/08/2001 CA 10.0 10 M 01/12/2001 Redness, swelling and pain to left deltoid. On 1/12/01 at 14:30 was seen by MD. Ice to area and Motrin. Rechecked on 1/13/01 and mother states area looks better than yesterday. Improvement after ice application on 1/12/01. Y U 01/10/2001 01/11/2001 1 PUB PUB 1
0166743 03/08/2001 MI 3.0 3 F 02/26/2001 A vaccine was give on 02/22/01 at approximately 2 PM. It was noticed that approximately 3 hrs later, the left arm (below shoulder to elbow) was warm, and a purplish color. She was taken to the doctor at 12 noon on 02/24/01. The doctor felt he couldn't confirm a prescription . Went back to doctor on Sunday and he felt it was a reaction. Y Y 02/22/2001 02/24/2001 2 NONE PUB PUB NONE NONE Asthma 1
0166744 03/08/2001 CA 0.3 0 .3 F 02/15/2001 This infant had a fever, coryzal symptoms; approximately 24 hours post-vaccination. She was seen in the ER. Y Y 02/12/2001 02/13/2001 1 PVT PUB NONE NONE NONE Fever~DTaP (no brand name)~1~0.20~In Patient CA010014 1
0166745 03/08/2001 CO 1.6 1 .6 F 02/22/2001 Approximately 1-1 1/2 hours after her Prevnar injection, she developed macular-papular rash (non-pruritic) generalized, no fever, no urticaria, no respiratory involvement. The patient was given Benadryl. Observed for 30 minutes, no worsening rash (no local inflammation). The patient stayed in the same state of health except for continued rash. Y Y 02/22/2001 02/22/2001 0 NONE PUB PUB NONE Slight URI. NONE 1
0166746 03/08/2001 PA 1.08 0 .8 F 02/20/2001 Approximately 8 hours post-vaccination, the patient was lethargic for 5 minutes, then fussy, and excessive crying for 3 hours, temp 102.6. Treatment was cool compresses to the site, Tylenol and Motrin. The patient fell asleep after 3 hours of crying. Y 10/26/2000 10/26/2000 0 PVT PVT NONE NONE NONE 1
0166747 03/08/2001 GA 0.2 0 .2 F 02/28/2001 This infant had brief periods of hypo-responsiveness, paleness, and irritability. Continuous crying, difficult to console, localized erythema at the injection sites. Incidents occurred at home as per mom. Y 02/20/2001 02/20/2001 0 PVT PVT NONE NONE NONE 1
0166748 03/08/2001 VA 0.7 0 .7 F 02/22/2001 This child had Prevnar administered to her on 02/13/01. On 02/17/01, the patient had a rash on her face, trunk and legs. She was seen in the ER 02/17/01 and given Atarax syrup, and advised to use warm compresses to the injection site. Discharged from ER. Y Y 02/13/2001 02/17/2001 4 PVT UNK NONE 1
0166749 03/08/2001 MD 2.0 2 .0 F 01/26/2001 Within a few hours after receiving her first and only Prevnar injection at the well baby visit on 01/25/01, the patient developed a high fever of 104. and a seizure. The patient was taken by ambulance to the hospital where additional seizure activities occurred. She was sent home after her ER observation on Tylenol and Motrin. Y Y 01/25/2001 01/25/2001 0 U/A 1.020, WBC 13,600, Hgb 13.9, Hct 40.3, PH 334K, Calcium 10.7 mg%. PVT PVT Amoxicillin (01/16) Ear infection Sickle cell trait, premature thelarche. 1
0166750 03/08/2001 FL 1.4 1 .5 M 01/30/2001 On 01/29/01, a phone call from patient's mother; the child had a seizure at 5 PM on 01/28/01. Also had a fever of 103, the mother was giving Motrin. Called the EMS. The patient was evaluated by EMT, he was not taken to the hospital. No other seizures. Y 01/25/2001 01/28/2001 3 NONE PUB PUB NONE Runny nose. NONE 1
0166751 03/08/2001 MN 1.5 1 .5 M 02/26/2001 This infant had a red raised area at the site of injection 25 mm. The rash inferior aspect of the left ankle extending to the bottom of his foot. Additional rash on under toes of the left foot. Y 02/22/2001 02/24/2001 2 PVT PUB 1
0166752 03/08/2001 WI 2.0 2 .3 F 02/24/2001 This patient had a red, swollen arm noticed this AM. The site feels warm, about 2" below the injection site, area of about 2" long. Slightly itchy. Y 02/22/2001 02/24/2001 2 PVT PVT Albuterol MDI Mild URI Occasional otitis media, wheezes. 1
0166753 03/08/2001 WA 1.25 1 .3 F 02/17/2001 This infant had a fever and febrile convulsion. Y Y 02/07/2001 02/14/2001 7 CXR, WBC, Bld Culture, BMP. PVT PUB NONE NONE 1
0166754 03/08/2001 TX 2.0 2 .7 M 02/12/2001 This patient's mother noticed a rash on his legs on 02/06/01. The mother brought the patient in the clinic on 02/07/01 and the doctor prescribed Atarax on 02/07/01. Y N 02/05/2001 02/06/2001 1 PUB OTH Mantoux, Connaught, left inner forearm, lot # C0016AA. NONE NONE 1
0166755 03/08/2001 PA 3.0 3 F 01/31/2001 This child had a fever and hives on 01/30/01. The hives started on her hands. No other cause of physical exam. Y 01/29/2001 01/30/2001 1 Clinical Evaluation. PVT OTH NONE NONE PA0119 1
0166756 03/08/2001 NC 1.3 1 .4 F 02/14/2001 On 02/10/01, this patient developed a red raised rash on her legs, arms, and stomach. Areas different sizes with largest about dime size. Areas worse on 02/11/01 and went to ER. The patient was given Benadryl IM, she had a low grade fever after the injection. Y Y 02/07/2001 02/08/2001 1 NONE PUB PUB NONE NONE Allergy to cherries. NC01019 1
0166757 03/08/2001 NC 4.0 4 F 02/14/2001 This child was in on 02/14/01 at 4:05 PM with complaints of a rash; she had vaccinations this AM, 02/14/01. The rash was noted at the right wrist, underneath both eyes, behind her right ear and left and right thighs. The left thigh worse than the right, rash red and raised , small hive cluster together. The child c/o of itching, no swelling, difficulty swallowing, or breathing. The grandmother instructed to use Benadryl and Hydrocortisone cream to rash areas, keep the child cool and bathe in oatmeal bath. If any swelling, difficulty breathing or swallowing noted take her to the ER or call 911. U 02/14/2001 02/14/2001 0 PUB PUB NONE NONE NONE NC01020 1
0166758 03/08/2001 NC 1.5 1 .6 F 02/19/2001 This patient had a "quarter sized" area of erythema at the injection site 2 days after receiving the injection. The child was taken to the ER on 02/18/01. The child was asymtomatic other than a 8x5 cm erythematous patch on her right thigh. No intervention given. The child was presented to the clinic on 02/19/01 with a 7 x 5 cm erythematous patch. Exam otherwise normal. Afebrile. The child will return in 2 days for a follow up. Y Y 02/16/2001 02/18/2001 2 NONE PVT UNK Otitis Media, URI Iron deficiency anemia, reactive airway disease. NC01021 1
0166759 03/08/2001 PA 0.5 0 .6 M 02/23/2001 This infant had muscle swelling at the injection site, tenderness, overlying redness, and a low grade fever. Y 02/22/2001 02/23/2001 1 NONE PVT PVT NONE NONE NONE 1
0166760 03/08/2001 MI 1.3 1 .3 M 02/28/2001 This infant had urticaria and a rash. Y 02/13/2001 02/19/2001 6 NONE PVT PVT Amoxicillin, Augmentin. Ear infection. NONE 1
0166761 03/08/2001 MI 6.0 5 F 02/27/2001 This child had hives, and facial edema (periorbital). Y 02/20/2001 02/21/2001 1 U/A - small leukocytes trace ketone. Urine culture - Neg. PVT PVT NONE NONE NONE 1
0166762 03/08/2001 IL 1.08 1 .1 F 02/26/2001 This patient had redness (onset at 2:40) at the site of Prevnar injection, resolving spontaneously during 48 hours after vaccinations. Y 02/24/2001 02/26/2001 2 PVT PUB 1
0166763 03/08/2001 CO 0.5 0 .5 M 02/27/2001 This infant had a temperature of 103, and a decreased appetite. Y 02/13/2001 02/15/2001 2 PVT PVT NONE NONE 1
0166764 03/08/2001 VA 0.3 0 .4 M 03/01/2001 This infants right leg with 1 1/2 - 2 cm redness, 3 x 3 cm induration. U 02/26/2001 02/28/2001 2 PVT PVT NONE Bronchiolitis NONE WAES01040903 1
0166765 03/08/2001 VA 0.3 0 .3 F 03/01/2001 This infant's right thigh had 2 distinct areas of 1 cm induration and redness. U 02/27/2001 02/28/2001 1 PVT UNK NONE NONE 1
0166766 03/08/2001 HI 1.0 1 .0 F 02/22/2001 This infant had a fever of 100 - 103 from 02/17/01 to 02/19/01. She had diarrhea on 02/18/01 and 02/19/01. Y 02/16/2001 02/17/2001 1 CBC, Chem 7, Blood Culture, Stool Culture, U/A W/ Reflex, PVT PVT NONE NONE NONE 1
0166767 03/08/2001 DE 29.0 28 M 02/27/2001 After this patient's shot #1, at approximately 8 PM (same day), the patient reports a rash (red band, with white raised bumps) may be 10-12. This rash was on the right wrist, underneath the thumb area. The rash was itchy, and is still itchy today, but redness is not as bad and the white bumps have gone down. At approximately the same time (8 PM last night) right leg was numb from top of the right gluteal area all the way to the foot, the majority of numbness has lessened, however, the right knee and foot (ankle-inner area) are still numb, the knee is the worst. The patient also reports numbness in the right deltoid area and right elbow. (Feel as if the right side was in "icy hot".) N 02/26/2001 02/26/2001 0 NONE MIL MIL IPPD 02/05/01. NONE A year ago pulled upper back muscle at the base of the neck. 1
0166768 03/08/2001 CA 23.0 23 M 02/26/2001 This patient had redness, tender to the touch, swelling for one week, largest area at approximately 75 mm x 75 mm. Y N 02/01/2001 02/03/2001 2 MIL MIL NONE NONE NONE 1
0166769 03/08/2001 DE 37.0 36 M 02/23/2001 This patient has back aches, a rash in the groin area, and a rash under the arms. N 01/13/1999 01/13/1999 0 MIL OTH 02/03/99 Anthrax, Bioport, Lot #FAV030, right arm. 06/03/99, Anthrax, Bioport, Lot # FAV041, left arm. 11/21/99, Influenza, Connaught, lot # UO168AAW. 12/07/99, Anthrax, Bioport, lot # FAV044, left arm. 06/07/00, Anthrax, Bioport, lot # FAV NONE NONE 1
0166770 03/08/2001 TX 52.0 52 M 01/18/2001 This patient complains that 48 hours later he developed a blotchy rash on his head and arms with an itch to his head. The patient took over the counter Benadryl with resolution of rashy itch. Y 01/16/2001 01/18/2001 2 OTH PUB NONE Allergy to Penicillin. 1
0166771 03/08/2001 WA 49.0 59 F 12/06/2000 This patient complained of upper respiratory infection since 11/23/00 and felt better. She had flu shot on 11/28/00. Complained of headache, sore throat, body ache, cough, nausea, vomiting, diarrhea, and a fever of 100.6. This patient had sickness for 5 days, she's feeling better today. Y 11/28/2000 11/28/2000 0 NONE OTH OTH Vitamin A, Trilisate, Maxide, Ranitadine. Arthritis, GERD WA011727 1
0166772 03/08/2001 WA 66.0 66 F 12/06/2000 This patient had swelling right of her injection site, red with streaking into anterior shoulder, hot to touch, red translucent, large patch 4" x 5" anterior medial middle 1/3 of upper arm. Distal ok, temp 98.4. Y Y 11/29/2000 12/01/2000 2 PVT UNK Septra Sinusitis Allergy to Morphine. WA011726 1
0166773 03/08/2001 WA 44.0 44 F 12/21/2000 Approximately 1 hour after her shot, this patient's arm developed stiffness, and soreness. By 4 hours, extremely stiff and sore, involving entire left deltoid region (Sternum - backbone) and part of the left side below. Approximately 5 hours after, the patient had a period of moderately tight chest and shortness of breath, some dizziness, stiffness and pain persisted all night; now resolving. U 12/20/2000 12/20/2000 0 NONE PUB UNK Zestril, Gingko Biloba. Arthritis, Diabetes (type II) Arthritis and diabetes type II WA011725 1
0166774 03/08/2001 WA 31.0 31 F 12/21/2000 This patient had tightness in her chest, shortness of breath, light headedness; starting about 2 hours after her injection. The patient admits history of panic attacks and states the symptoms are consistent with those. Y 12/07/2000 12/07/2000 0 PVT UNK Dimetapp 12 hour Allergy. Food Allergies (not eggs), asthma, bee sting. WA011724 1
0166775 03/08/2001 WA 71.0 71 M 12/21/2000 This patient received both his Influenza shot and Pneumonia shot on the same day. The arm became swollen, red, and hot. The swelling extended down the arm. Y Y 12/13/2000 12/14/2000 1 NONE PUB PVT NONE NONE WA011723 1
0166776 03/08/2001 WA 20.0 20 F 01/26/2001 Within 24 hours following Wyeth brand flu vaccine, the patient had a local reaction approximately 2 1/2" x 1 1/2" redness on her right deltoid, warmth, and itching. Started on Zyrtec. Resolved on it's own no antibiotic needed. Y 01/09/2001 01/10/2001 1 PVT UNK Paxil, Depo-Provera NONE WA011715 1
0166777 03/08/2001 WA 53.0 53 F 12/08/2000 Pt reports after having flu shot that evening developed redness and swelling of upper arm, became more pronounced over next 2 days. Also had defined raised hive like rash . Y 12/04/2000 12/04/2000 0 PUB PVT Horse serum allergy. WA011710 1
0166778 03/08/2001 PA 53.0 53 F 01/16/2001 This patient began experiencing itching and raised areas on her face, neck, back, and trunk of body on 01/16/01. Raised areas are erythemic and "splotchy" in appearance. Areas are fading at the present. The patient has not discussed with her MD. Denied any new foods, changes in behavior, and changes in medications. She planned to discuss with her MD. Denies any problems with initially from the vaccine. Immunization site no evidence of erythema, edema, extreme, irritation or other problems. Y 01/11/2001 01/15/2001 4 NONE MIL PUB Luvox, Lithium, Clonipin. NONE Mental health meds only; had and allergic reaction last spring or summer on arms and legs. She doesn't know from what. PA0116 1
0166779 03/08/2001 MA 44.0 43 F 01/08/2001 Pt reports onset of severe vertigo, tinnitus, cold sweats, nausea and vomiting, feeling of being off balance, blurry vision with nystagmus. Unable to drive times 3 1/2 weeks due to incapacitating vertigo, relieved by lying flat in quiet room. Y 10/17/2000 10/29/2000 12 WBC 18.8 PVT PUB Multivitamin 1
0166780 03/08/2001 MA 38.0 38 F 12/14/2000 Pt experienced tightness in chest, wheezing 3 minutes post injection. Y 12/08/2000 12/08/2000 0 PUB PUB Pt had allergy to eggs as a child, but eats them all the time now. MA0020 1
0166781 03/08/2001 WI 14.0 15 M 01/16/2001 Pt received vaccine, several minutes later he became diaphoretic, flushed complained of lightheadedness and some tightness in his chest. BP 128/68, P88.Ten minutes later BP 120/60, P80, flushing and diaphoresis diminished. Y 01/15/2001 01/15/2001 0 PUB PUB Albuteral, Singular, Flovent, Saconent Asthma, allergies 1
0166782 03/08/2001 CA 45.0 45 F 11/14/2000 Pt received vaccine this am. At 1:30pm pt complained of itching covering entire left arm. Treated with benadyl, ice. 11/14/2000 11/14/2000 0 PVT PUB 1
0166783 03/08/2001 IL 19.0 19 F 02/27/2001 Redness, mild edema 5to 6cm around injection site. 02/19/2001 02/19/2001 0 PVT UNK 1
0166784 03/08/2001 MD 46.0 46 F 12/01/2000 Pt reports post 10 minutes of vaccine he felt funny, throat dry, burning in chest. Pt was able to breathe, no swelling noted, called 911. Y 12/01/2000 12/01/2000 0 OTH OTH Tofronil, Avaolria, Glucophage Diabetes, Cardiac problems Diabetes, HTN, Cardiac problems. 1
0166785 03/08/2001 AZ 4.0 4 F 01/26/2001 This patient had localized cellulitis, tenderness, redness, and a fever. Y 01/23/2001 01/26/2001 3 NONE PVT PVT NONE NONE Reactive airway disease - moderate. 1
0166786 03/08/2001 MA 12.0 12 M 02/09/2001 The patient complained that he had a headache, dizziness, and he felt agitated. The patient was better when seen at around 8 PM on the same day. U 02/08/2001 02/08/2001 0 NONE PVT PUB Tegretol NONE Allergy to Bactrim. History of seizure. 1
0166788 03/08/2001 AL 13.0 13 F 02/16/2001 This patient received Hep B #3 on Feb 8 (morning) at school. The mom called PHN on Thurs, Feb 15,. On Weds, Feb. 14th, the patient came home from school, showered, ate dinner, soon after he developed generalized itching, then hives which became gradually worse covering her trunk area, neck, shoulders, arms, behind knees. Rash and itching subsequently 2/16. Didn't sleep well due to itching, but no other symptoms. At the time of initial conversation, the mom wasn't sure whether the daughter had eaten anything "new" at schools valentine celebration, or had used a new body wash, shampoo or cream rinse. In a hurry to get off the phone to purchase Benadryl at only local store before closing. Inquiring about any known connection with Hepatitis B vaccine. On Friday, February 16, PHN called someone with the State Immunization Program. Has never heard of this type of reaction to Hep B vaccine. Especially unlikely after #3 vaccination and 6 days later. Advised to complete VAERS form. Return call to mother. Rash and itching subsided after use of Benadryl. The daughter did attend school today did not check with daughter regarding whether shampoo or angel food cake for valentine's day dessert at the Family home. No previous reaction to eating strawberries, but mom aware that allergic reaction can happen with subsequent ingestion of foods. Plans to get allergy testing for daughter. Note: Local PA on vacation from clinic on 02/15/01 for 1 month. No other local medical providers. The mother plans to fly with the daughter only if no resolution of sickness of the next several days. Y 02/08/2001 02/14/2001 6 NONE OTH UNK NONE NONE Allergy to Penicillin 1
0166790 03/08/2001 MO 18.0 18 F 01/03/2001 This patient received Hep A shot on 12/07/00. Starting 12/14/00 she has had episodes of hives (almost daily), starting on her face, and then covering the rest of her body. The physician has prescribed her with steroids and antihistamines. The patient's dad reports 12/28/00, hives continue. Y U 12/07/2000 12/14/2000 7 PVT OTH UNK 1
0166791 03/08/2001 AZ 4.0 4 M 01/26/2001 The right deltoid upper arm has a red spot, tender, and hot to touch. Area size of a small orange on 01/25/01 at 10:23 PM. Y 01/24/2001 01/25/2001 1 NONE PVT PVT NONE NONE NONE 1
0166793 03/08/2001 MI 14.0 14 M 12/27/2000 Ten days following this patient's Hep B # 2, the patient had petit mal seizure. The mother reports patient's head jerked back, and their was LOC for approximately 20 minutes. No signs and symptoms of tonic clonic movement. No residual effects seen by the MD. This patient was given extreme testing to determine cause of seizure. He was seen by a Pediatric rheumatologist. In the doctors opinion the rapid drop in Ana titer would indicate a reaction to the Hep B rather than an autoimmune problem. Y Y 09/21/2000 10/01/2000 10 ANA - 1:1280 (a few days after the seizure) & 1:320 on 12/13/00. PUB PUB NONE NONE NONE ~DTP (no brand name)~2~0.30~In Sibling 1
0166794 03/08/2001 AZ 2.6 1 .5 M 01/29/2001 This child had vaccine failure. Varivax given on 07/11/00, in 12/00, the patient had chicken pox with over 100 lesions. Y 07/11/2000 NONE PVT UNK NONE NONE Mild eczema. 1
0166795 03/08/2001 CA 33.0 F 03/02/2001 Information has been received through the pregnancy registry from a physician concerning her sister-in-law, a 33 year old female who was vaccinated with varicella virus vaccine live. Shortly thereafter, the pt was found to have been 2 weeks pregnant at the time of vaccination. Follow-up was received which indicated the pt had a 1st trimester elective abortion. No medical indication was reported; the decision was personal. No further information is available. Follow up on 06/29/2001: "Patient date of birth, adverse event onset date/time, lot # for vaccine 1, vaccine administration date/time is not provided." U OTH OTH UNK Pregnancy (LMP-UNK) WAES99082119 1
0166796 03/08/2001 CO 0.3 0 .3 F 01/31/2001 The patient was seen for well check 24 hour after seeing cardiology everything appeared well for this patient, had vaccines, no fever, became congested and heart stopped. Y 01/25/2001 N 01/25/2001 01/25/2001 0 MANY PVT PVT Sulfatrim, vitamin D & E VSD, ASD, PDA with a bicuspid valve, severe bilirubinemia, paralyzed below the waist, extension deformities of knees, clubfeet. Meningomyelocele and clubfeet were dx'd prenatally. Baby born by C-section after 36 hours of labor and stayed in the hospital 3 weeks. She has a feeding tube in her nose which the parents use for gastric lavage. The hips are high and dislocated and the knees are dislocated. She has spina bifida of the lumbosacral region, horseshoe kidney, VSD, ASD, PDA with a bicuspid aortic valve, pulmonary hypertension, jaundice, fracture femur, direct hyperbilirubinemia. Trisomy 18, Cholestasis, omphalocele, CHF 1
0166801 03/08/2001 NY 36.0 F 04/30/2001 A physician reported that a 36 year old female received an injection of influenza virus vaccine on an unspecified date. Eight days, post vax, the pt was hospitalized with meningitis. Additional information has been requested. Y U UNK OTH OTH UNK UNK UNK HQ6348124JAN2001 1
0166802 03/08/2001 NH 48.0 48 F 01/08/2001 On 10/29/00 onset of nausea and dizziness while in shower, felt unsteady and off balance with whoring vertigo, bilateral tinnitus broke out in a cold sweat and vomited. On 10/30/00, had severe dizziness and was unable to walk without losing balance, veering off to sides. Seen by MD where I work and was given Vistaril IM for nausea and vomiting and scopolamine patches. On 11/2/00, seen in ER as there is no improvement and now also have blurry vision, no appetite with nausea and vomiting, severe tinnitus bilaterally and decreased hearing with bilateral ear fullness. Given IV Phenergan and Antivert. Dx'd with viral labyrinthitis that could take 3 weeks to go away. On 11/10/00, saw ENT because was getting worse; feeling weak and shaky. Rx'd with Valtrex and Valium. Had 3 subsequent flu visits with ENT and Rx'd prednisone, 2 more 7 days courses of Valtrex and Dyazide to decrease fluid in inner ear. Repeat Audiogram on 12/6/00 showed improvement. Unable to drive or work for almost 4 weeks due to severe vertigo and unsteady gait. On 12/29/00, developed swelling of right jaw and neck that is tender to touch and moves when swallowing but no sore throat. I have upper back pain (feel like my head is too heavy for my neck to support. Left arm and leg weakness. On 12/19/00, pt (functions continue to deteriorate). Fatigue and tires easily from 11/01/00 to present 1/8/01. Treatment: Vitamins, Tylenol, physical therapy, rest and flu shots. Y Y N 10/16/2000 11/01/2000 16 CBC & Chem profile-WNL except WBC-18.8; Audiogram-showed sensorineural hearing loss;Xray-Cervical cord disc disease; lab work-(-); MRI- Acute demyelination disorder vs MS; EEG-(-); Lumbar Puncture-(-) PVT PUB Glucophage, Norvasc, Multivitamins, Folic Acid; thiamine NONE NIDDM; HTN 1
0166805 03/08/2001 VA 43.0 43 M 02/28/2001 This patient had an hyperglycemic episode, onset of insulin. Dependent diabetes, no previous history. Y Y Y N 01/30/2001 02/09/2001 10 Plasma glucose-500 PVT PVT NONE NONE NONE 1
0166806 03/08/2001 MN 1.0 1 .0 M 02/27/2001 On 2/22/01, seen in clinic with bilateral otitis media and given Amoxicillin and Augmentin. Had a few papules around mouth. On 2/24/01, at 09:55, pt had a generalized tonic/clonic seizure at home. Came to ER with temperature of 36.3C. Acting normal at 12:00 and 14:00, had another seizure (each lasting about 45 seconds). Admitted; afebrile for 3 days. Y Y Y 02/16/2001 02/24/2001 8 Blood cultures and CSF cultures-no growth; CT head-nml; EEG-nml; RBC-15.5; WBC-12.4; ESR-12; CRP-0.3 PVT OTH Amoxicillin, changed to Cefzil and Augmentin Persistent Otitis NONE 1
0166807 03/08/2001 FL 0.08 0 .1 M 01/10/2001 Noticeable head swelling, seizures, vomiting, interventricular hemorrhage after 2nd Hep-B (Engerix) at less than 6 weeks of age. Dates were from 12/15/95 through hospital admission on 1/25/96. Pt received the 1st Hep-B at less than 24 hours of age on 11/4/95. A nurse told me he was trembling (probably a seizure). Recent information and research regarding bleeds in the brain and the link with vaccinations has proven the pt's catastrophic event is directly the result of an adverse reaction. Y Y Y 85 Y Y N 12/15/1995 12/15/1995 0 PVT PVT NONE NONE NONE Seizure~Hep B (Engerix-B)~1~0.00~In Patient 1
0166808 03/08/2001 NH 0.2 0 .2 M 02/28/2001 On 2/15/01, given vaccines at well child visit. On 2/19/01, noticed lump in right groin. Began Keflex for adenitis. On 2/23/01, right inguinal abscess-drained by surgeon. Admitted for IV antibiotics from 2/24/01 to 2/27/01 and re-incision and drainage on 2/24/01. Still healing and under treatment. Y 4 Y 02/15/2001 02/19/2001 4 WBC-18.2; 11 Bands; 47 Polys; PVT PUB NONE Hypospadias 1
0166809 03/08/2001 FL 0.2 0 .2 F Pt had tonic contractions with eyes rolling back X 2 episodes; clinically resembling a seizure. Y 3 Y 02/15/2001 02/16/2001 1 CAT Scan of Brain-nml; EEG-nml PUB PUB NONE NONE NONE 1
0166810 03/08/2001 IN 0.5 0 .5 M 02/23/2001 Pt was sleeping and found not breathing, with gray-blue coloring. Responded to tactile stimulation. Called 911. Evaluated in office and admitted for observation. Normal exam. Possible "near sids". Y 1 Y 02/19/2001 02/20/2001 1 EEG-nml PVT PVT NONE 1
0166811 03/08/2001 WI 0.2 0 .2 F 03/01/2001 Fever and vomiting, beginning approx. 24 hours, post vax. Had 20 minutes of being hyporesponsive and pale spell. Resolved by the time of ER visit. Temperature to 101F, triggered septic workup which was negative. Diagnosis Pyelonephritis Y Y 2 Y 02/15/2001 02/16/2001 1 Cultures normal PVT PVT NONE Originally, slow to gain weight. 1
0166812 03/08/2001 KY 1.25 1 .3 M 03/05/2001 Immediate rash developed which started at limbs (extremities) and spread immediately (2-3 minutes) up trunk and upper extremities; (very fine macular rash). Child has no difficulty with respiration until was seen by pediatrician and had developed rash and wheezing. Y 1 Y 03/02/2001 03/02/2001 0 PUB PUB Fe Gth NONE NONE 1
0166813 03/08/2001 PA 47.0 47 M 02/16/2001 Pain on leg, numbness in crotch, face, mouth, arms, feet and rectum. Burning in feet, down inside of legs, testicles, sharp jabs of pain in chest, cold sweats, tired, light-headed, queasy sick, joint pain in all joints, headaches and numbness all over. All symptoms come and go from day to day. Symptoms have been less and milder since March 2000, but still have all the symptoms, to this day. (no treatment) 60 day follow up states patient experienced burning across shoulders, down arms, and hands. Patient has tingling in face and top of head and stomach pain. Y Y Y N 10/13/1999 10/20/1999 7 Blood test done on 12/99 at hospital-showed high signs of Lyme Disease and was told not to get 3rd shot. Also seen by a neurologist. PVT PVT atenolol 25mg 1
0166815 03/08/2001 CT 45.0 45 F 03/02/2001 Information has been received from a pharmacist concerning a 45 year old Caucasian female, who on approx. 1/25/01 was vaccinated with Hep-B and "shortly thereafter", the pt experienced "anaphylactic reaction. Client had itchy rash, shortness of breath, and her throat was closing." On 1/25/01, the pt went to the ER and was treated and released. On 1/26/01, the pt again experienced "anaphylaxis" and went to the hospital and was admitted for 3 days. Anaphylactic reaction and anaphylaxis were considered to be immediately life-threatening. Additional information has been requested. F/U on 1/29/01 the pt was discharged from the hosp with a dx of anaphylactic reaction of unknown etiology, probably secondary delayed reaction to hepatitis B vaccine. The nsg reported that the pt has not had anymore anaphylactic reactions. Anaphylactic reaction and anaphylaxis were considered to be immediately life threatening. Additional info has been requested. Follow up on 06/29/2001: "Lot # for vaccine 1 is not provided." Y Y Y 3 Y U 01/25/2001 01/25/2001 0 UNK UNK UNK UNK WAES01021835 1
0166818 03/08/2001 WI 62.0 61 F 01/30/2001 After 2nd of 3 vaccinations of Lymerix, I became stiffer in the knees, hips and back. I had trouble walking for more than 2 or 3 blocks. This is unusual. Y U 07/01/2000 Before 7/99 or 7/00, I was tested for active Lyme disease-result 0 PVT UNK Prempro NONE Joint stiffness~Lyme (LYMErix)~2~61.00~In Patient 1
0166819 03/08/2001 NJ 0.6 0 .6 M 03/01/2001 Fever to 103F X 3 days with irritability. Pt was evaluated on 3rd day and found to be with significant leukocytosis with the irritability and fever. Pt was admitted. Diagnosed with acute URI and mild gastroenteritis Y 1 Y 02/22/2001 02/24/2001 2 CBC; Blood culture-(+) staph (contaminant); Urine culture-neg PVT UNK NONE URI Hemangioma on forehead 1
0166820 03/08/2001 PA 2.0 2 .0 F 02/27/2001 This child had a fever of 103F, complaining of severe jaw pain, no redness, or swelling. U 02/26/2001 02/26/2001 0 NONE PVT PVT NONE Mild URI NONE 1
0166821 03/08/2001 WI 0.8 0 .8 F 03/01/2001 During the 1st 24 hours, this child had a fever of 100.8; she responded to Motrin. Then it seemed ok until the 2nd night, she had a spiked fever of 102.5. The 3rd day , the fever again 101 to 102.5. she was seeing the MD on the 3rd day. Now recovering. U 02/26/2001 02/26/2001 0 PUB PUB NONE NONE NONE 1
0166822 03/08/2001 GA 2.0 2 .4 F 02/27/2001 This infant had an onset of fever within one hour of the vaccination. The temperature was 103 to 104 for 48 hours. The patient had severe loss of appetite, he would drink but did not eat any solids. She also complained of leg pains at the injection site and was limping. Y 02/19/2001 02/19/2001 0 Physical exam - Nml, except child was limping. PVT PUB NONE NONE 1
0166823 03/08/2001 TN 0.8 0 .9 M 02/28/2001 The infant was taken to the PMD on 02/28/01 with a rash and a fever within 24 hours after his Prevnar injection. The patient is crying, irritable, chokes easily, dime sized, red maculo-papular rash to the abdomen, buttocks, and shoulder since the night before, also blisters on the buttocks. Difficulty breathing this AM while eating. PMD feels it is a reaction to the vaccine does not recommend to repeat vaccine, also diagnosed pharyngitis. Y Y 02/27/2001 02/27/2001 0 PUB PUB NONE NONE 1
0166824 03/08/2001 MA 0.2 0 .2 F 03/01/2001 This infant's dad walked in to report events of the night before. His daughter received a vaccine about 4:30 PM and at 9:30 PM, she started crying (in a different way)made 8 girggled noises with her back arched, she then turned blue and then became white as paper. Not tonic clonic. The parents called 911 and child appeared ok when they arrived but cried and didn't open her eyes or feed for 3 hours. No treatment or hospital visit. Y 02/28/2001 02/28/2001 0 NONE PVT UNK NONE NONE NONE 1
0166825 03/08/2001 CT 1.7 1 .7 M This child received Prevnar on 02/23/01. On 02/24/01, he had a temp of 104.3,and "body shaking". he was sent to the ER with a febrile seizure. On 02/26/01, the patient was seen by PCP fever down, giving Tylenol/Motrin alternating. No other sickness, positive coryza, slight cough, TM's nml, throat nml, A/P URI, febrile seizure. Hold future Prevnar. Y U 02/23/2001 02/24/2001 1 PVT PVT Tylenol, Motrin NONE NONE 1
0166826 03/08/2001 FL 1.6 1 .6 M 02/09/2001 This infant's mother telephoned at 9 AM on 02/09/01, to report that the child was ill since last evening, vomiting, and diarrhea 2 times, severe since this AM. Had no thermometer to determine the temp, but felt hot; consulted with the doctor. The doctor advised the mother to take the child to the ER in case the child need IV fluids for dehydration, call to relate outcome. The parent did not return the call; so the writer contacted the phone # at 5:50 PM, left a message for the mother to call. No reply! Y U 02/08/2001 02/08/2001 0 PUB OTH NONE Was cranky and fussy "wanted juice not water". NONE 1
0166827 03/08/2001 AZ 2.0 2 .0 M 03/05/2001 This infant developed hives all over his body, erythema multiforme 1 day after his vaccination. The patient is on Augmentin for 1 week, also treatment for periorbital cellulitis. Oral steroid started and Augmentin. Y U 03/02/2001 03/03/2001 1 PVT PVT Augmentin 1 week prior periorbital cellulitis. NONE 1
0166828 03/08/2001 WA 4.0 4 M 02/27/2001 The patient was normal when he went to bed at 9:30 PM. Awoke about 11:00 screaming, legs cramping, yelling it hurts, throat sore (could swallow liquid), could bend chin to chest. The fever and chills resolved by arrival to the ER, he was coherent, given instructions for croup all though not quiet, typical barking cough. seems fine in AM. Y U 02/26/2001 02/26/2001 0 PVT PUB NONE NONE Febrile seizure 10/3/98. Hydrocele 2/8/99. 1
0166829 03/08/2001 CA 0.2 0 .2 M 02/28/2001 This patient seized approximately 24 hours s/p receiving immunizations. Generalized tonic clonic movement, opisthotonic posturing, eye rolls, post-ictal, afebrile. Self resolved after treatment. The hospital in NICU at the time of events. No further Seizure activity. Y 02/19/2001 02/20/2001 1 Mild elev CRP. CBC - Wnl. ASX, CSF, Urine, Blood CK - Neg. PVT UNK Reglan Prader Willi Syn, Reflux prematurity. 1
0166830 03/08/2001 NM 0.3 0 .2 M 03/01/2001 This patient's mother describes 10 hours of crying after immunization given. The left thigh was very tender and caused crying when touched. She gave him Tylenol. The baby would not eat". The mom reported lump a the Comvax injection site. Could be felt 1 month later, now resolved. Y 12/29/2000 12/29/2000 0 PVT OTH NONE NONE 1
0166831 03/08/2001 TX 0.2 0 .2 M 03/05/2001 This infant had fussiness within 24 hours after his shot lasting for more than 6 days, decreased sucking, and difficulty falling asleep. U 02/27/2001 02/27/2001 0 UNK PVT PVT Sacralfate, Prilosec. NONE Peptic Ulcer Disease. 1
0166832 03/08/2001 NC 1.08 1 .1 F 02/22/2001 This infant has a nickel-size slight erythema, firm control site. Non-tender to the touch. Mother did not see until 2 weeks after vaccine given, no fever. Y 02/08/2001 02/22/2001 14 NONE PVT PUB NONE NONE NONE 1
0166833 03/08/2001 NJ 0.4 0 .4 F 02/27/2001 This patient's mother called and stated her child had a temp of 102 on 2/16. The child screamed for 3 hours the night after the vaccine on 02/15. Y 02/14/2001 02/15/2001 1 PVT PVT 1
0166834 03/08/2001 IN 0.75 0 .8 M 03/05/2001 This infant has a nodule on his right thigh. Y 11/27/2000 01/17/2001 51 PVT UNK NONE NONE 1
0166835 03/08/2001 FL 2.0 2 .1 F 03/06/2001 Eight (8) hours post vaccination this patient's mother picked the child up to change her diaper; the child screamed and fought being handled. Seemed to be in a lot of pain. Her arms and legs were flailing but her trunk was limp. The patient could not sit or stand alone. Call to the MD. Went to the ER via ambulance. No temp, no injection site reaction. ER staff offered diagnosis of "transient reaction to vaccinations". Resolved 4 hours after onset. No treatment. Y Y 03/05/2001 03/05/2001 0 NONE PVT PVT NONE NONE Was a "Methadone Baby" no known sequale. 1
0166836 03/08/2001 FL 1.0 1 .0 M 03/01/2001 This patient was given an MMR along with Varivax, IPV, and Prevnar on 02/20/01. He came into the clinic on 02/28/01 with a rash on his face and his chest, that developed the day before. The patient was on an antibiotic 5 days ago from the ER. Y Y 02/20/2001 02/27/2001 7 PUB PUB NONE NONE NONE 1
0166837 03/08/2001 DE 65.0 65 M 03/06/2001 A 15-day follow up report received 8/7/2003 adds: Report A0344264A (formerly 2001005626-1) describes rheumatoid arthritis in a 65-year-old male who received Lyme disease vaccine recombitant OspA (Lymerix). This report was received from the pt. Additional info was received as part of litigation proceedings, with forwarding of medical records. The pt reported that he had been active in playing golf, hunting, fishing, camping, traveling and gardening, along with caring for his 4 grandchildren, ages 4 to 9 until April 2000. Until April 2000 he had reportedly been in "excellent health". He had no known allergies. Medical records indicated that his medical history included tinea versicolor, diet-controlled hyperglycemia, hypercholesterolemia, hypertriglyceridemia, hemorrhoids, Dupuytren's contracture of the hands (1997), hand stiffness, osteoarthritis of the lower back and flat feet. The pt sustained a skull fracture during a motor vehicle accident in the 1950's. HLA-DR analysis by polymerase chain reaction (PCR) on 11/01/2000 was negative for HLA-DR4 and HLA-DR2. There were no known drug allergies. Surgical history included Dupuytren's contracture surgery "years ago", hemorrhoidectomy (1955), radical excision of plantar fibromatosis of the right foot (02/18/1998) and arthroplasty of a deformed 5th digit on the right foot (02/18/1998). Concurrent medications included vitamin E, metoprolol tartrate (Lopressor), nitroglycerine (Nitropaste), atorvastatin calcium (Lipitor), diltiazem hydrochloride (Tiazac), acetylsalicylic acid, isosorbide mononitrate (Imdur) and magnesium. The pt was a former smoker for 20 years (quit approx 1966). He had asbestos exposure in the past. He drank 3 to 4 beers and "2 cocktails" a week on average. A 15-day follow up report received 10/15/2003 adds: Following the reported onset of rheumatoid arthritis, the pt experienced hypertension, atypical chest pain, coronary artery disease, mitral annular calcification, "mild" aortic sclerosis without stenosis, "1+" mitral regurgitation, "1+" aortic regurgitation, paroxysmal supraventricular tachycardia, atypical pneumonia, and a tear of the left achilles tendon. These were not reported as adverse events due to vaccine administration, but were found during the course of review of the pt's medical records. Theyfore, they are not listed as adverse events. The pt reported that he received his 1st and 2nd injections of Lymerix in April 1999 and May 1999, respectively. He stated that he had no adverse events following receipt of these injections. He reported that he received his 3rd injection of Lymerix on 04/18/2000. He claimed that within a few days, he developed progressive fatigue, weakness, and gradually increasing shortness of breath. The pt also noted that one week after the 3rd injection, he "couldn't get out of bed" with stiffness in his hips, neck ankle and knees. He reportedly could not close his hands to make a fist. His stiffness had improved "slightly over the months", but he still had "stiff joints, mainly in (his) knees, ankles and hands." The pt stated, "My latest blood work has shown no inflammation in my system now." On 02/11/2002, in a Statement of Injuries, the pt's attorney alleged that the pt "suffers from joint pain and fatigue. He also suffers from fibromyalgia." The following info was obtained from medical records. Laboratory analyses performed on 05/03/2000 revealed Lyme total antibodies to total immunoglobulins index, measured by EIA, 7.96; rheumatoid arthritis (RA) factor 108.9 IU/mL, erythrocyte sedimentation rate (ESR) 43 mm/hr, and rapid plasma reagin (RPR) non-reactive. On 05/22/2000, Lyme total antibodies to total immunoglobulins index, measured by EIA, was 10.31. Western blot analyses for Lyme IgG and IgM were negative. The pt was seen by a rheumatologist on 06/08/2000 to be evaluated for a "relatively acute onset of articular pain that happened in April. He seems to correlate the onset of this articular involvement with a 3rd dose of Lyme vaccine. Since then he has been presenting morning stiffness. swelling and pain in the small and large articulations. He has also been having difficulty sleeping, tossing and turning, and waking up during the night secondary to pain. He mainly refers that the shoulder area and the muscles in the proximal portion of the arms is what hurts. Although, in the past he has also had problems with the elbows, hands, knees and feet. The pt refers that at times the swelling is severe and the stiffness is more prevalent in the morning that lasts between one and two hours, but lately all of the symptoms have become a little bit better since he started on Celebrex (celecoxib)." The rheumatologist noted that the medical history was "Remarkable for contraction of the hands. Foot surgery on the right foot in the past and has a history of flat feet." Medications at the time of the evaluation included Celebrex 100 mg twice daily and vitamin E. Under review of systems, the rheumatologist wrote, "The only problem he is actually having is the diffuse arthralgias and myalgias and morning stiffness as described above. Also, he has sleep disturbances and some degree of fatigue associated with the discomfort that he is experiencing." On physical examination, blood pressure was 138/96 mmHg. "He has some stiffness and decrease in range of motion, mainly related to stiffness in the upper extremities - shoulders and elbows. In the hands he has some decrease of range of motion. There is no active or overwhelming synovitis of the wrists, MCPs (metacarpophalangeals), PIPs (proximal interphalangeals), or DIPs (distal interphalageals). In the lower extremities he had good range of motion of the lumbosacral spine, and knees and hips, though he has some elements of osteoarthritis in both knees. There is no evidence of synovitis in the knees, ankles, or feet. There is also some wasting of the muscles of the quadriceps muscles bilaterally. The muscle mass seems to have decreased recently. Impression: 1. Articular pain of unclear etiology, rule out rheumatoid arthritis. Certainly the possibility that this may be related to Lyme disease is raised by the correlation of the injections with the onset of symptoms." The rheumatologist prescribed a short, tapered course of prednisone and cyclobenzeprine (Flexeril) at bedtime. Laboratory analyses performed 06/08/2000 were significant for reduced red blood cell (RBC) count, hemoglobin and hematocrit (please see Laboratory Data section). C-reactive protein concentration was elevated. Total protein concentration was within the reference range, but gamma globulin was elevated. Protein electrophoresis indicated that "Gamma increased appears polyclonal on agarose gel". The pt returned to the rheumatologist on 06/29/2000. "Overall he is doing better on low doses of Prednisone. There is a decrease in the amount of articular pain. His inflammatory markers are still slightly elevated, but not as before. He has been noticed in the past to have positive rheumatoid factor as well. His Hemoglobin is 12 and Hematrocrit 35. C-reactive protein is 19." Medications at the time of this office visit included Celebrex 100 mg twice daily, Flexeril, prednisone 5 mg daily, and vitamin E. On physical examination, blood pressure was 150/80 mmHg. "Extremities were symmetrical without significant evidence of synovitis. Pt has good range of motion of articulations. There is some tightness in the lower extremities especially when squatting. IMPRESSION: 1) Articular pain probably RA." On 07/14/2000, RBC, hemoglobin, and hematocrit remained reduced. RA factor was elevated. Antinuclear antibody (ANA) titer was 1:80 (reported as "Borderline") with a speckled pattern. The pt was seen by the rheumatologist on 07/19/2000. "He had improved since the last visit but recently he had plateaued. He remains with significant articular discomfort. C-reactive protein is slightly elevated. Overall he is not feeling well. He is very frustrated and angry about the onset of symptoms. He blames this on the vaccines for Lyme's (sic) disease." On physical examination, blood pressure was 132.80 mmKg. "Extremities were symmetrical without significant evidence of synovitis. Pt has some fullness on the MCPs and wrists bilaterally. IMPRESSION: 1) Articular pain probably RA, secondary to inflammatory characteristics and positive rheumatoid factor." The rheumatologist added hydroxychlorouine (Plaquenil) 200 mg twice daily to the pt's medication regimen. The pt was seen by the rheumatologist on 09/06/2000. "He is doing better at this time. He is taking low doses of Prednisone and, secondary to a mild degree of inflammation, we'll start (him) on Plaquenil as well. He remains with some discomfort in the articulations, but, clearly, it is less than what he experienced in the past." Medications included Celebrex 100 mg twice daily, prednisone 5 mg daily, Plaquenil 200 mg twice daily, and vitamin E. On physical examination, blood pressure was 128/72 mmHg. "The extremities were symmetrical without evidence of synovitis. There was good range of motion and no significant problems were noticed today on exam. Impression: 1. Rheumatoid arthritis. 2. High risk medications." On 09/11/2000, the pt was seen by his primary care physician for a routine visit at which time he was found to be slightly short of breath and very tachycardic. The pt reported that he while golfing earlier that morning, he felt a little short of breath and felt chest discomfort which he thought was "indigestion". Physical exam revealed a pulse of 153 and a grade II/VI systolic ejection murmur. His lungs were clear. He was also noted to have good range of motion, pain in the right Achilles tendon, which was tendonitis, but no warmth or effusion at these joints. Some mild synovitis in the left knee was noted. Impression and Plan: Pt admitted to rule out possible myocardial infarction or unstable angina. He was treated (Nitro paste) and metoprolol (Lopressor) intravenously. Hydroxychloroquine sulfate (Plaquenil) and celecoxib (Celebrex) were held until there was no moreo evidence of arrhythmia. An electrocardiogram (ECG) ruled out a myocardial infarction and subsequent ECG's were normal. A Persantine Cardiolite stress test revealed anterior ischemia. Chest X-ray revealed "marked vascular congestion with possible inflammation at the left base. This could, however, simply represent a manifestation of the vascular congestion". The pt was discharged on 09/13/2000. Discharge diagnoses were supraventricular tachycardia converted to sinus rhythm, hypertension, rheumatoid arthritis, and coronary artery disease. Discharge medications included diltiazem HCl (Tiazac), enteric coated aspirin (Ecotrin) and isosorbide mononitrate (Imdur). The pt was seen by a cardiologist on 09/20/2000, for evaluation of the abnormal nuclear stress test. The cardiologist noted, "He is very active including fishing, hunting and walking the golf course without problems." Medications at that time included Celebrex 200 mg twice daily, hydroxychloroquine 200 mg twice daily, prednisone 5 mg daily, isosorbide mononitrate (Imdur) 30 mg daily, extended-release diltiazem (Tiazac) 120 mg daily, enteric-coated aspirin 500 mg daily, and vitamin E 800 units daily. On physical examination, blood pressure was 125/99 mmHg. On 11/01/2000, HLA-DR analysis by PCR did not demonstrate HLF-DR4 or HLA-DR2. On 11/20/2000, RBC, hemoglobin, and hematocrit remained reduced. C-reactive protein concentration was within the reference range. The pt returned to the cardiologist on 11/13/2000. The cardiologist noted, "He has been able to walk 18 holes of golf". Medications included atorvastatin (Lipitor) 10 mg daily, Celebrex 200 mg twice daily, hydroxychloroquine 200 mg twice daily, prednisone 5 mg daily, Tiazac 120 mg daily, aspirin 325 mg daily and vitamin E 800 units daily. Blood pressure was 134/84 mmHg. The pt returned to the rheumatologist on 12/06/2000. "Most recently the pt has had no elevation in inflammatory markers, but he remains with significant discomfort in the shoulders and soft tissues. He is getting increasingly frustrated by the amount of discomfort he is experiencing. He feels that the Lyme vaccine is the etiology for all these problems and is something that he could have avoided...He seems to be bothered also by the fact that despite our interventions and now that the inflammations are under control, he is not feeling better. On the contrary, he is hurting all over and feeling very tired." Medications at that time included Celebrex 200 mg twice daily, prednisone 5 mg daily, Plaquenil 200 mg twice daily, Lipitor 10 mg daily, Tiazac 120 mg daily, acetylsalicylic acid daily, and vitamin E. On physical examination, blood pressure was 170/100 mmHg. "The extremities were symmetrical without significant synovitis. There was soft tissue tenderness noted today on examination. Impression: 1. Rheumatoid arthritis. 2. Early stages of fibromyalgia. The pt seems to be very frustrated by the fact that he is not feeling better despite the amount of medications that he is taking. I am concerned that he seems to have a worsening of soft tissue tenderness and the fact that having negative inflammatory markers he remains with significant pain." The rheumatologist prescribed Flexeril at night. The pt was seen by the rheumatologist on 01/23/2001. The pt "comes for evalulation with a history of a positive rheumatoid factor associated with inflammation and was treated with Plaquenil and Prednisone initially with control of symptoms. Subsequently, he has developed persistent arthralgias and myalgias and significant fatigue. At this time, he refers that his articulations are "killing him". The amount of pain he's having is very dramatic. He is not comfortable with the current medications. He is growing increasingly frustrated due to the amount of pain and discomfort he experiences daily." On physical examination, blood pressure was 156/100 mmHg. "The extremities revealed no evidence of synovitis, no significant decrease in the range of motion although stiffness is noticed in the articulations. Impression: 1. Rheumatoid arthritis. 2. Early stages of fibromyalgia. 3. It is not clear how this correlates with the Lyme vaccine that he received in April 2000. Secondary to the fact that I have controlled the inflammation, I have treated him with tricyclics in an attempt to control what seems to be early stages of fibromyalgia. Since he is not doing better, I have discussed the possibility of referring him to the University Center for further treatment and for a second opinion." The pt was referred to the tertiary care center on 01/31/2001. The pt was evaluated by a physician at the tertiary care center on 03/22/2001. At that time, he reported that his symptoms began "several weeks" after his 3rd injection of Lymerix. On physical examination, the physician noted "tenderness and swelling of multiple large and small joints" and knee effusions. He noted no subcutaneous nodules or evidence of cutaneous vasculitis. The physician write, "I fee (the pt) definitely has rheumatoid arthritis and although he has been on low dose Prednisone, Plaquenil and Celebrex his disease remains very active and he has a high probability for the development of erosions, deformity and disability...I have recommended that he consider Remicade (infliximab) infusions. I also advised him about participating in a clinical trial currently being conducted using Remicade in early rheumatoid arthritis in Methotrexate naive individuals...of course treatment with more standard agent such as Methotraxate or Arava (leflunomide) remain a viable option." On 03/22/2001, rheumatoid factor and erythrocyte sedimentation rate were elevated. Hand x-rays revealed abnormalities. Analysis of synovial fluid aspirated from the left knee revealed an increased concentration of polymorphonuclear lymphocytes. Please see Laboratoy Data section. The vaccine provider made a telephone call to the pt on 04/02/2001, regarding a recent chest x-ray. In the office notes, the physician wrote, "Pt has increased intersitial markings on chest x-ray and will need follow-up with pulmonary consult...Also pt tells me he'll be in a research trial of MTX (methotrexate) and Remicade (infliximab) with ...rheumatologist at (the tertiary care center) for his R.A. Currently just taken off Plaquenil." On 04/17/2001, the pt presented to the ER complaints of "severe" shortness of breath that had progressively worsened since 04/16/2001, non-productive cough, and chills. The pt reported that he was "discharged from (another hospital) on 4/11 with diagnosis of rheumatoid arthritis/scar tissue on lung suspect secondary to Lyme vaccine". His nail beds were blue and his color was pale. While receiving 3 liters/minute of oxygen via nasal canula, oxygen saturation was 97%. The physician's impression was acute dyspnea and pulmonary fibrosis. The pt was given a single intravenous injection of methylprednisolone (SoluMedrol). He was discharged with portable oxygen and his daily dosage of prednisone was increased. The pt returned to the ER via ambulance on 04/23/2001 with a chief complaint of shortness of breath. The paramedic report stated that the pt was examined in his home for a chief complaint of shortness of breath. Paramedics administered nebulized albuterol and ipratropium as well as oxygen. During transport to the hospital, the pt's breathing became easier. At the hospital, the pt stated he was "recently to have fibrosis" in March of this year. He underwent a week long evaluation at (a tertiary care center). He was referred to see a pulmonologist. When he arrived for his outpatient evaluation he was tachycardic. He was hospitalized for "one week" at (the tertiary care center). The pt states that he had no bronchoscopic or thoracic lung biopsies. He did have a CT scan of the chest. He was due to be reevaluated for a "rheumatoid lung protocol at (another tertiary care center)." Since discharge from (the first tertiary care center), the pt has had progressive relentless dyspnea. This has been primarily breathlessness and not associated with cough, sputum production, or wheezing. He was seen (in the ER) approx 5 days ago and started on oxygen. Despite the initiation of oxygen, his dyspnea has continued to worsen. I carefully questioned the pt, his wife, and his daughter. They all feel this is a progressive process without any dramatic intercurrent deterioration. He is basically, "going downhill every day". The pt relates that his lung problem began following Lyme vaccination. Except for the pt's claim there is nothing to substantiate the relationship at this juncture." One of the consulting physicians noted that the pt "was felt, at least by (the 2nd tertiary care center) to have a rheumatoid lung as well back sometime late last year." On physical exam, the pt was dyspneic and his head, eyes, ears, nose and throat revealed mild cushingoid facies. Ascultation of the lungs revealed "diffuse velcro type rales" that did not clear with deep cough. Chest x-ray performed in the ER revealed "diffuse pulmonary fibrosis with a near, "white out," to the left lung." White blood cell count, eosinophil count, and platelet count were elevated. The physician's assessments were "1. Severe hypoexemia. 2. Diffuse lung disease. A) Possible rapidly progressive interstitial pneumonitis (Hammond-Rich type syndrome). B) Pulmonary fibrosis, plus intercurrent lung process. C) Rule out eosinophilic pneumonia. D) Rule out optimistic (sic) pneumonia, on corticosyteroids. E) Rule out viral pneumonitis. 3. Esonophilia on corticosteroids. 4. Hypertension. 5. Hyperlipidemia. 6. Rheumatoid arthritis." The pt was admitted to the hospital and with intravenous SoluMedrol, intravenous ceftriaxone, and intravenous azithromycin. "The pt's condition on admission is critical and his prognosis is poor." CT of the chest revealed "Extensive air space and ground glass density in the lungs." The pt underwent thorascopic left lung wedge biopsy on 04/24/2001. The pathologist's diagnoses were "1. Acute and organizing pneumonia with bronchiolitis and occlusion, consistent with BOOP (bronciolitis obliterans with organizing pneumonia). Negative for identifiable fungal elements and Pneumocystitis (sic) carinii organisms. 3. No evidence of malignancy. 4. Microbiology cultures - negative to date." Testing for Legionella was negative, and no eosinophils were seen in a sputum sample. A 2nd pathology opinion was obtained, "which revised the diagnosed to diffuse alveolar damage of some elements of bronchiolitis. The exact etiologic diagnosis was never ascertained." The lung biopsy was complicated by pneumothorax that required the placement of multiple chest tubes. The pt was dependent on mechanical ventilation and required permissive hypercarbia throughout his hospital stay to avoid plateau pressure exceeding 35 mmHg. The pt became febrile approx 13 days after intubation, and had purulent, tan sputum. He was seen by an infectious disease specialist who noted a primary problem of "Diffuse alveolar damage - ARDS (adult respiratory distress syndrome) like syndrome. The entire process present for over the past year appears to have newly worsened over the past 3 weeks. This is incompatible with any infectious disease process." He also noted that a secondary infection as the reason for the present hospital admission had been ruled out by the open lung biopsy. However, based on examination of sputum, a diagnosis of Enterobacter cloacae nosocomial ventilator-associated pneumonia was made. The pneumonia was treated with the following intravenous antiobiotics: vancomycin, piperacillin/tazobactam, trimethoprim/sulfamethoxazole, and ciprofloxacin. The hospital course was further complicated by right pneumothorax, acute gastrointestinal bleed with anemia felt to be secondary to gastritis (required blood transfusions), prolonged ileus, acute renal insufficiency felt to be a toxic reaction to trimethoprim and sulfamethoxazole, steroid-induced diabetes mellitus, atrial fibrillation, thrombocytopenia, and hypersmolar state with components of hypernatremia, azotemia, and hyperglycemia. Other medications administered during the hospitalization included heparin, salbutamol, ipratropium, digoxin, famotidine, acetazolamide, sodium bicarbonate, and insulin. He was also treated with total parenteral nutrition. The pt developed tachycardia, then torsade de pointe. He underwent initial cardiopulmonary resuscitation, then designated "comfort only care". He subsequently expired on 05/27/2001. Cause of death was recorded as "Cardiac arrhythmias complicating chronic respiratory failure". No autopsy was performed. Info received on 08/16/2002 indicated that respiratory failure, possibly as a complication of rheumatoid arthritis, was fatal. Therefore, this report has been reclassified as serious, unlabelled. The most recent info received on 09/23/2003, provided details on treatment received from paramedics prior to the hospitalization on 04/23/2001. A 15-day follow up report received 10/31 /2003 adds: The most recent info received on 10/17/2003, provided chest x-ray results from 02/26/2001 and 03/26/2001. Follow up on 12/12/03: "The most recent information received on 11/26/2003, a hospital discharge summary, provided additional details regarding the vaccinee's hospital tx from 04/23/2001-05/27/2001." Y N 04/18/2000 04/25/2000 7 ANA Titer: Negative; anion gap: 6mmol/L; anion gap: 2mmol/L; bended neutrophils: 1%; Bended neutrophils: 11%; Basophil: 1%; Basophil: 0%; c-reactive protein, serum: 19.4mg/L; C-reactive protein, serum: 6.2mg/L; c-reactive protein, serum: 4.8mg/L; creatining, serum: 1.2mg/dL; creatinine, serum: 1.4mg/dL; eosinophils, blood: 8%; eosinophils, blood: 0%; erythrocyte sedimentation rate: 43mm/hr; erythrocyte sedimentation rate: 76mm/hr; gamma globulin: 2.1g/dl; haematocrit: 35.6%; haematocrit: 33.1%; haematocrit: 39.5%; haematocrit: 34.6%; haematocrit: 29.0%; haemoglobin: 12.1g/dL; haemoglobin: 11.1g/dL; haemoglobin: 13.1g/dL; haemoglobin: 11.8g/dL; haemoglobin: 8.8g/dL; lymphocytes, blood: 10%; lymphocytes, blood: 1%; monocytes, blood: 2%; monocytes, blood: 3%; myoglobin: 199ng/ml; neutrophils, blood: 78%; occult blood, gastric fluid: positive; Platelet count, blood: 801,000/cumm; Platelet count, blood: 463,000/cumm; Platelet count, blood: 94,000/cumm; Protein, serum, total: 7.6g/dL; RBC: 4.03x10^6/uL; RBC: 3.70x10^6/uL; RBC: 4.34x10^6/uL; RBC: 3.89x10^6/uL; RBC: 2.84x10^6; Rheumatoid factor: 108.9IU/ML; Rheumatoid factor: 106.8IU/L; Sputum eosinophils: none; Urea nitrogen, blood: 22mg/dL; Urea nitrogen, blood: 60mg/dL; WBC: 19.600/cumm; WBC: 30,500/cumm; WBC: 10,600/cumm; Lyme antibodies/IG index, exam date: 05/03/2000, result text: 7.96 (positive >1.10); Lyme antibodies/IG index, exam date: 05/22/2000, result text: 10.31 (postive > 1.10); Lyme IgG Western blot, exam date: 05/22/2000 result text: negative; Lyme IgM western blot, exam date: 05/22/2000 result text: negative; ANA titer: exam date: 05/03/2000 result text: negative (<1.40); ANA titer, exam date: 07/14/2000 result text: 1:80 (borderline) w/speckled pattern; RPR exam date: 05/03/2000 result text: non-reactive; Protein electrophoresis, exam date: 06/12/2000 result text: gamma increased appears polyolonal on agarose gel; Chest x-ray 09/11/2000: impression: marked vascular congestion w/possible inflammation at the left base. This could, however, simply represent a manifestation of the vascular congestion." HLA-DR PCR exam date: 11/01/2000 result text: No HLA-DR4 or HLA-DR2; X-rays left lower leg/left foot/left heel 12/13/2000: impression: degenerative changes." Chest x-ray 02/26/2001: impression: mild progression of interstitial lung markings; there could be a component of active interstitial inflammation." Synovial fluid analysis, left knee 03/22/2001: Viscosity: "good" (reference range, "very good"); Mucin: "good" (Reference range, "good"); white blood cell count: 2275 cells/cu mm; polymorphonuclear neutrophils: 34% (reference range, 0.0-1.9%); Monocytes: 66%; Crystals: none. X-rays, hands 03/22/2001: Diagnosis: bilateral degenerative changes consistent w/osteoarthritis." Chest x-ray 03/26/2001: "Impression: No change in appearance of chest. Continued increased intersitial lung markings." Lung, wedge biopsy, left thoracoscopy and biopsy, 04/24/2001: Final Diagnosis: 1. Acute and organizing pneumonia w/bronchiolitis and occlusion, consistent w/bronchitis obliterans w/organized pneumonia (BOOP) 2. Negative for identfiable fungal elemetns and pneumocystitis carnii organisms 3. No evidence of malignancy 4. Microbiology cultures-negative to date." Arterial blood gases, performed between 04/23/2001-05/26/2001: pH ranged from 70382 to 7.495 (reference range 7.350-7.450) pCO2 ranged from 29.8 to 127.6 mmHg (reference rage 35.0-45.0) pO2 ranged from 39.8 to 116.5 mmHg (reference range 75.0-120.0); Lung culture for Legionella, 04/24/2000: no growth; PUB OTH Vitamin E, Lipitor (atorvastatin calcium, Tiazac (extended-release diltiazem hydrochloride, aspirin, Isosorbide mononitrate, Metoprolol tartrate, Nitroglycerin, Magnesium salt, acetylsalicylic acid The vaccinee's allergies and concomitant medications were not specified. The vaccinee had been active in playing golf, hunting, fishing, camping, traveling, gardening, along with taking care of four grandchildren ages four to nine until April 2000. Until April 2000, patient had reportedly been in "excellent health." Arthroplasty, asbestos exposure, Dupuytren's contracture (with surgery for), ex-smoker, Fibromatosis, flat feet, foot deformity, fractured skull, hand stiffness, hemorrhoidectomy, hemorrhoids, hypercholesterolemia, hyperglycemia, hypertriglyceridemia, motor vehicle accident, osteoarthritis, tinea versicolor. Follow up received 2-1-2002. Medical history was "remarkable for contraction of the hands." The vaccinee underwent surgery on his right foot for an unknown reason. Patient also had flat feet. There were no known allergies. HLA DR analysis by polymerase chain reaction (PCR) on Nov 11, 2000 was negative for HLD-DR4 and HLA-DR2. Concurrent medication included Vitamin E. 20010056261 1
0166838 03/08/2001 43.0 F 03/06/2001 Subsequently, in addition to experiencing unspecified adverse events, she experienced deteriorating eyesight(NOS) and was losing her mental capacities. U OTH OTH 20010056221 1
0166839 03/08/2001 NJ 47.0 M 03/01/2001 After receiving 3rd injection of LymeRix pt reported arthralgia lasting 2 to 4 weeks. End of October pt received Influenza vaccine pt experienced arthralgia then dysesthsias. Pt has experienced spasms. Y N PVT PVT 1
0166840 03/08/2001 LA 34.0 34 M 02/21/2001 3 hours post vaccine pt noted right hand felt warm, no other signs, symptoms. Normal exam. Y Y 02/20/2001 02/20/2001 0 MIL MIL 1
0166841 03/08/2001 KS 24.0 24 M 02/26/2001 red, itchy, 3 1/2 inch swelling. Painful to touch. Y 02/23/2001 02/24/2001 1 MIL MIL IPPD/Con/C0520BA/l arm/2/23/2001 1
0166842 03/08/2001 WA 51.0 51 F This patient had local swelling, and soreness at the injection site. Prescribed Benadryl. Y 12/18/2000 12/21/2000 3 PVT UNK NONE GERD, smoking. WA011716 1
0166843 03/08/2001 AZ 53.0 53 F 02/23/2001 On 01/04/01, this patient was given the Influenza injection to the left arm. Within 1 1/2 hours after the injection, the patient's upper arm became warm to the touch with a discoloration of red approximately 6 x 6 inches in diameter. Tenderness at the sight. Reaction lasted for 4 days. No sickness, nausea or vomiting, headaches, difficulty breathing. Informed to take Tylenol. Also the patient was seen by a military doctor who prescribed Benadryl and Hydrocortisone cream. Y 01/04/2001 01/04/2001 0 MIL MIL 1
0166844 03/08/2001 CA 50.0 50 F 03/02/2001 This patient had a flu shot on 10/30/00 AM. He went to see the eye doctor 11/01/00 for another reason, but noted right eyelid drooping. Two weeks after, complained of tingling from both arms and legs and facial weakness. Two weeks after, hospitalized under telemetry x4 days due to complaints of weakness from both the upper and lower extremities with right weaker than left, tachycardia, and palpitation. Y N 10/30/2000 11/01/2000 2 12/00 Nerve Conduction test - Abnormal. Brain and C-spine MRI, Brain MRA, LP, Head CT Scan, and EMG - Normal results. PUB PUB NONE NONE NONE 1
0166845 03/08/2001 RI 1.0 1 .0 M 12/26/1999 Decreased or restricted appetite or diet; withdrawal of social skills; irritability; abnormal responses to voices and other environmental stimuli; decrease in eye contact or social reciprocal interactions; loss of language; bizarre play behaviors; extreme irritability. Dx'd with autism by 5/29/96. 60 day follow up states the pt has autism, heavy metal toxicity, autoimmunity, candiasis, apraxia. May never recover from these. Y N 03/29/1995 03/29/1995 0 NONE PVT OTH TB test on 3/29/95 URI NONE 1
0166846 03/08/2001 RI 5.0 5 M 12/26/1999 This child has regression in acquired skills (from in home ABA program), screaming, crying, tantrums, noncompliance, and irritability. N 05/04/1999 06/01/1999 28 NONE PVT OTH Autism Autism~Measles + Mumps + Rubella (no brand name)~1~1.00~In Patient 1
0166847 03/08/2001 NC 38.0 38 F 03/01/2001 This patient reports shortness of breath lasting 3 minutes with confusion (2 episodes) after returning home. MMR site red, warm to touch. Has blister and skin tear approximately 10 mm (left upper arm). Y 02/26/2001 02/26/2001 0 UNK UNK PPD, Intradermal, Unk. NONE 1
0166848 03/08/2001 MS 8.0 5 F 02/27/2001 This patient broke out in a rash and bumps all over her body on 02/20/01, itching a lot. Diagnosed 02/21/01 with chicken pox. Treatment: Atarax syrup, Zovirax liquid. Y U 09/15/1998 02/20/2001 889 PVT OTH Ventolin, Intal. Allergic rhinitis. History of asthma. 1
0166849 03/08/2001 MS 3.0 1 .0 M 03/24/2001 This child had 4 small lesions, and a rash. Diagnosed on 02/23/01 with chicken pox. Treatment: Atarax. Y U 12/10/1998 02/23/2001 806 PVT PVT Zithromax URI Allergic rhinitis, Sinusitis. 1
0166850 03/08/2001 CA 3.0 3 M 02/16/2001 This child complains of stomach ache and he was lethargic on 01/17/01; he stopped talking on 01/19/01. Went to the ER on 01/20/01. The child complained of headache on 01/18/01. Diagnosed with encephalitis on 01/22/01. Child talking again but unable to form many thoughts; no longer counting to 10. Y N 01/10/2001 01/17/2001 7 CT Scan on 02/12/01. PVT PUB NONE NONE Allergies. CA010015 1
0166851 03/08/2001 IL 1.0 1 .1 F 02/20/2001 This infant vomited 3 xs in the middle of the night, when she awoke, she had a fever. Y 05/22/2000 05/23/2000 1 PVT PUB NONE NONE Unspecified.~DTaP (no brand name)~3~1.08~In Patient 1
0166852 03/08/2001 NJ 0.3 0 .4 M 02/22/2001 The patient's mother states His right leg was found to be "swollen", noted 1 day after his immunization. He was given Benadryl and ice. On physical exam 2 days after noted to be larger but no swelling / edema or inflammation. N 02/13/2001 02/14/2001 1 X-ray - Neg PVT PVT NONE NONE 1
0166853 03/09/2001 NY 44.0 43 F 02/27/2001 Day one- The patient contacted the clinic with complaints of right arm pain and tenderness. The patient was advised by nurse to ice affected arm and to try Tylenol. Day two- The patient examined due to complaints of severe (10/10) right shoulder pain, significant pain noted on external rotation and the patient is unable to hold her arm at 90 degrees. Diagnosis of bursitis, rotator cuff tendonitis, and capsulitis. Patient was started on Prednisone and Lortab. Day 6- The patient continues to have right shoulder pain, Celebrex was started. Day 17- The patient was diagnosed with right bicipital tendonitis. The patient continues to have disability in her right arm. She can not perform her daily activities. Y N 01/05/2001 01/06/2001 1 MRI of right shoulder- showed small tendon. PVT PVT NONE Colitis 1
0166854 03/09/2001 NC 54.0 54 F 06/18/2001 This patient had severe pain in her right arm at the site of vaccination. Unable to raise her arm. The pain radiates length of arm. Cannot lift items. Y N 09/27/1999 PUB OTH 1
0166855 03/09/2001 WA 32.0 31 F 03/01/2001 This patient had immediate development of hives at the injection site then progressed to hives over the left eye and later shortness of breath and periorbital swelling. She was treated with Benadryl PO, and Solumedrol IV. She developed nausea and vomiting. She was admitted over night, and discharged 02/21/01. She has continued with generalized hives. The patient is being seen by the allergist, dermatologist, and internist. Y Y 1 U 02/20/2001 02/20/2001 0 Normal labs - including liver tests and CBC's. PVT PVT Diluent Lot Number UA282BA NONE history of urticaria, angioedema- presumed idiopathic. 1
0166856 03/09/2001 OK 1.6 1 .8 M 01/30/2001 This child developed severe otitis media with TM rupture 4 days after immunizations. Physical exam on day of vaccination showed ears completely closed. U 01/25/2001 01/29/2001 4 PVT PUB NONE Congenital small head syndrome. 1
0166857 03/09/2001 CT 46.0 46 F 02/22/2001 Pt reports L arm swelling, pain, generalized aches, fever 101F, severe malaise. Y 02/14/2001 02/14/2001 0 PVT PVT Multi vitamins, calcium NONE NONE 1
0166858 03/09/2001 CA 18.0 18 U 01/12/2001 Pt reports swelling on sides of chest under arm, bumps around injection site x 6 hrs. Y 01/09/2001 01/09/2001 0 MIL MIL 1
0166859 03/09/2001 VA 4.0 4 F 02/22/2001 Pt reports swelling R thigh at injection site, erythema, warmth, no pain. Y 02/19/2001 02/20/2001 1 PVT OTH Multivitamins NONE NONE 1
0166860 03/09/2001 NY 11.0 11 M 02/28/2001 Pt reports scattered pruritic rash, varicella lesions with fever, not allergic reaction. Y U 02/13/2001 02/25/2001 12 PVT UNK NONE 1
0166861 03/09/2001 GA 1.0 1 .0 M Pt reports blistery spots on back, scalp, neck, buttocks,and face. 09/19/2000 PVT UNK Mild URI Amoxicillin, GERD 1
0166862 03/09/2001 AR 12.0 12 M 02/12/2001 Reported giant urticaria Y Y 10/04/2000 10/04/2000 0 PUB PUB NONE NONE AR0112 1
0166863 03/09/2001 TX 11 M 02/16/2001 Pt complained of dizziness, instructed to put head down. 1:45 child stood up walked to hall with Mom & said I'm tired, pt assisted to floor by RN, skin warm/dry, alert, complained of dizziness. Pt B/P 80/40. Y 02/16/2001 02/16/2001 0 PUB OTH Singular Asthma 1
0166864 03/09/2001 NJ 0.3 0 .4 M Pt increased crying for 4 days post vaccine, each time >3hrs. Y 12/29/2000 12/29/2000 0 PVT PVT NONE NONE NONE Cranky~DTaP + Hib (no brand name)~1~0.20~In Patient 1
0166865 03/09/2001 MA 4.0 4 M 02/27/2001 The mother came to the office with the pt at 2:15 pm stating "allergic reaction to shots" from earlier in AM. The pt received the vaccines around 11:30 - 11:45 on 2/27/01. The pt was presented with right entire face was raised and red. Treated with epinephrine and Benadryl. Y Y 02/27/2001 02/27/2001 0 O2 sats - 99-100%, Temp of 96.3, Heart rate- 80 PVT PUB NONE NONE hx of asthma, allergy to prelone and alupent 1
0166866 03/09/2001 NJ 45.0 45 F 02/03/2001 Pt reports rash at injection site 4"x 2" on 12/29/00, increased to 10" x 5" by 12/31/00, fever 102F, chills on 12/29 through 12/31. Affected area on arm was red swollen, hot to touch, sensitive, hard. gradually turned purple last 3 = wk's. Y Y 12/28/2000 12/29/2000 1 PVT PVT Allerga, flo-vent Asthma. allergy to pine trees 1
0166867 03/09/2001 AZ 46.0 46 F 02/26/2001 L elbow regional lymphadenopathy U 02/26/2001 02/26/2001 0 PUB OTH Paxil, vioxx, surmontil, darvocet, prargil, TB skin test Fibromyalgia, herniated back disc 1
0166868 03/09/2001 MA 25.0 25 F 02/16/2001 severe nausea, stomach pain Y 01/04/2001 01/04/2001 0 OTH PVT Penicillin allergy 1
0166869 03/09/2001 WA 49.0 49 F 01/04/2001 Pt reports fever within 2 hrs post vaccine 101.6F, lasted 6 days. Also severe malaise, joint pain, nausea and vomiting, diarrhea. Injection reaction. Y 10/30/2000 10/30/2000 0 PVT PVT Sulfa, ASA WA011728 1
0166870 03/09/2001 WA 1.4 0 .6 F 12/21/2000 2 days post vaccine reported rash total body. Y 09/25/2000 09/27/2001 367 PUB PUB WA011722 1
0166871 03/09/2001 WA 25.0 25 F 12/29/2000 The pt experienced erythema and vesicles. Diagnosed with cellulitis at the ER Visit. Treated with Diclox. Y Y 11/18/2000 12/08/2000 20 NONE MIL UNK NONE hx of migraines, depression, positive PPD WA011721 1
0166872 03/09/2001 WA 6.0 6 M 12/18/2000 Pt had chickenpox post vaccine. Y 05/13/1998 12/14/2000 946 PUB OTH WA011720 1
0166873 03/09/2001 KY 49.0 M 03/02/2001 It was reported that a 49 year old male pt received a TD Adult vaccination as well as an MMR II on 2/19/01. Reportedly, 2 days later, the pt reported tenderness in the left side of his chest, below the clavicle and slight redness and swelling at the injection site. The pt was seen in ER on 2/25/01 and admitted to the hospital with cellulitis. From telephone conversation on 3/2/01, it was reported that on 2/21/01, 2 days, post vax, the pt returned with redness, tenderness over entire left deltoid and a tender subclavicular node on the same side. The pt's condition worsened and he was hospitalized for 6 days after vaccine. The nurse believes the pt did well and has been discharged. The pt received IV Vancomycin; no surgery. Pt had no fever. F/U rec'd on 3/22/01, it was reported. The pt did not have redness, tenderness over entire L deltoid on 2/21/01. He complained that his L deltoid area and L arm was sore when he moved his arm. He had tenderness but no redness or swelling in the L side of his chest below the subclavicular area. The pt was examined on 2/21/01 and was told to continue to observe but at this time nothing was found to be out of the ordinary except his complaint of tenderness to chest. He was also instructed to return if he started having redness, increase tenderness or temperature. On 2/26/01, per phone call from administration that the pt had been admitted to the hospital 2/25/01 with cellulitis. As of 3/19/01 he is doing fine and working Also please note the MMR vaccine (was) rec'd in the R hip. Y Y 6 U 02/19/2001 02/23/2001 4 UNK UNK U2001004400 1
0166875 03/09/2001 NY M Telephone report received from a consumer on 02/27/01, regarding an adverse event possibly associated with Influenza vaccination. A retired veterinarian called to report that a male friend of his developed an autoimmune disease, glomerulonephritis, approximately 1 1/2 months after receiving an influenza vaccination. The patient required hospitalization and intravenous steroids. Recovery was complete; without known relapse. Medical history is significant for hypertension and hypercholesterolemia. This patient has had two subsequent influenza vaccinations without incident. No other info is available. Y Y Y 08/01/1999 10/01/1999 61 Creatine-almost 5.0 MIL OTH NONE Hypertension; high cholesterol MPI2001019100 1
0166876 03/09/2001 NY 85.0 F Telephone report received from a consumer on 2/27/01, regarding an adverse event, possibly associated with influenza vaccine. A retired veterinarian called to report that approx. 2 weeks, post vax, in late 1998, a female friend of his developed temporal arteritis. This progressed to optic neuritis, with subsequent blindness in her left eye. She was hospitalized and treated with IV steroids. She continues to take oral steroids. There has been some improvement in her vision. No other information is available. Y N 11/01/1998 11/15/1998 14 OTH OTH NONE Emphysema MPI2001019120 1
0166877 03/09/2001 FL 3.0 1 .0 F 03/07/2001 Child became chronically constipated. Odd behaviors began. Child withdrew socially; lost all communication skills and eye contact. Y N 03/13/1998 03/20/1998 7 PVT UNK NONE Ear infection, 2 weeks prior 1
0166878 03/09/2001 SD 5.0 5 F 10/03/2000 This child had an ER visit 09/02/00, complained of large red blotchy rash, joint pain, knee and ankle swelling. Bilateral otitis media, and a sore throat was noted. Henoch- Schonlein Purpura. Y Y Y 08/21/2000 09/02/2000 12 PUB PUB NONE NONE NONE SD00011 1
0166879 03/09/2001 NY 47.0 M 03/07/2001 Report 2001005254-1 describes elevation of AST and ALT in a 47 year old male who received Hep A vaccine (Havrix) for prophylaxis of Hep A. The vaccinee received Hep B vaccine (Engerix-B) on 02/02/01. On 02/02/01, the vaccinee received his first dose of Havrix. Thirteen days later, on 02/15/01, he was found to have elevated AST (719 U/L) and elevated ALT (1694 U/L). No symptoms were reported. This event is considered SmithKline Beecham medically serious. As of 02/26/01, the outcome of the adverse events is unresolved. N 02/02/2001 02/15/2001 13 02/15/01 AST - 719 U/L, ALT - 1694 U/L. OTH OTH 20010052542 1
0166880 03/12/2001 WA 68.0 68 F 01/09/2001 On 01/05/01, the patient was seen at the clinic for a nurse visit, complained of reaction to injection. Left upper arm swollen, outer surface red, warm, complaints of discomfort, and some itching. Patient instructed to use Benadryl. On 01/08/01, reported that the patient is resolved by 01/07/01 in the PM. Y 01/02/2001 01/03/2001 1 PVT PVT Prempro NONE Osteoporosis WA011717 1
0166881 03/12/2001 WA 1.7 1 .6 F 01/22/2001 The patient had redness, swelling, tender over right anterior thigh, site of DTAP, developed approximately 15 days post injection 2-3 " diameter swelling, redness. Resolved after 4 days with warm soaks. No antibiotics. Y Y 01/02/2001 01/19/2001 17 NONE PVT PUB URI NONE WA011713 1
0166882 03/12/2001 WA 6.0 6 M 12/05/2000 The patient's left arm was swollen, warm to the touch, and painful. A temperature was noted at school and checked by the school nurse. The school nurse sent the patient home and advised the mom to contact their doctor if it continues tomorrow or worsens today. To use Tylenol for the temp and pain, Benadryl for swelling, and ice and elevation for comfort, redness and swelling. Consult with the doctor. U 12/04/2000 12/05/2000 1 NONE PUB PUB NONE NONE NONE ~DTP (no brand name)~4~1.00~In Sibling WA011709 1
0166883 03/12/2001 PA 16.0 16 M 02/12/2001 This patient presented with red raised, blotchy, hives,without pruritis on abdomen, back, arms, and face on 02/09. Seen in the ER on 02/10 in the AM. Ordered Benadryl. Improving as of 02/12, started fading 02/09 from face and back. Y N 02/08/2001 02/09/2001 1 PUB PUB Sudafed Slight cold Allergic to Sulfa, Head injury at age eight years. PA0118 1
0166884 03/12/2001 PA 0.3 0 .3 M 01/24/2001 On 11/03/00, this patient's mother noticed a bulging anterior fontanelle. On 11/04/00, he went to the family doctor, who referred him to another doctor. On 11/19/00, the infant had a CT Scan of the head which was Nml. and head circumference remained stable. Bulging still continues. Y U 11/01/2000 11/03/2000 2 CT Scan of the Head- NML. PUB PUB NONE NONE NONE PA0117 1
0166885 03/12/2001 PA 31.0 31 F 01/19/2001 This patient received TD #1 and MMR #1, for immigration purposes on 10/24/00. The patient was informed at time of immunization for the need to avoid pregnancy for 3 months and condoms were given. Her husband was also made aware, he was able to speak english fluently and verbalized understanding. No adverse effects noted at that time for MMR. The patient's last monthly period as of 10/24/00 was 10/21/00. No pregnancy at the time of immunizations. The patient is seeing a doctor for continued follow up. U 10/24/2000 01/19/2001 87 PUB UNK NONE NONE NONE PA0120 1
0166886 03/12/2001 MA 24.0 24 M 01/04/2001 The patient got the shot and 12 hours later he couldn't even move his arm. His triceps were flaccid and he couldn't contract it so his arm was curled to his chest. The pain was bad for about 12 hours (12 - 24 hours after shot) and subsided about 48 hours after the shot. Not febrile. Y 12/21/2000 12/21/2000 0 UNK UNK Adderall Had 3 cold before the shot. MA0021 1
0166887 03/12/2001 CA 9.0 9 F 01/18/2001 This patient's mother said that her face was swollen after the shot. No redness, no fever, no other complaint. Y 12/18/2000 12/18/2000 0 X-ray of sinuses, CBC, U/A & C/S. PVT PUB 1
0166888 03/12/2001 CA 0.2 0 .2 F 12/26/2000 This infant had consistent high pitched crying for 3 1/2 - 4 hours. Y 12/20/2000 12/20/2000 0 NONE PVT PVT URI NONE 1
0166889 03/12/2001 IL 30.0 30 F 02/01/2001 This patient reports pleuretic chest pain after MMR injection (reported 1 + month later to the doctor). The patient did not call sooner, states left arm "sore", no rash, no fever, flu symptoms, no obvious deformity of limbs. Y 12/21/2000 12/21/2000 0 NONE PVT PVT NONE 1
0166890 03/12/2001 CA 23.0 23 F 01/29/2001 This patient had a 6 cm x 5 cm area of swelling, redness, and pain for 4 days after her injection. The patient reports flu-like symptoms for 2 days starting 24 hours after injection. U 01/26/2001 01/27/2001 1 OTH PVT Albuteral Inhaler. NONE 1
0166891 03/12/2001 MI 12.0 12 F 01/24/2001 Approximately 25 minutes post vaccine pt complained of headache, nausea,feeling faint, skin pale/dry. B/P 115/67, P60. Y 01/24/2001 01/24/2001 0 PUB UNK slight cough 1
0166892 03/12/2001 NE 32.0 32 F 01/15/2001 Pt reports redness and swelling at injection site. Pt complaining of feeling hot and lightheaded. pt taken to MD's office. Y Y 01/05/2001 01/05/2001 0 OTH PUB 1
0166893 03/12/2001 VA 6.0 6 M 02/09/2001 Pt seen 24 hrs post injection, L upper arm edematous, erythema and extremely tender to touch, warm to touch, pt febrile lasting 48 hrs. Y Y 02/06/2001 02/06/2001 0 PVT PVT Singular Asthmatic Allergic rhinitis, asthma, allergy to e-mycin 1
0166894 03/12/2001 WA 1.25 1 .3 M 02/22/2001 erythema, swelling, tenderness around the injection site. Y 02/19/2001 02/20/2001 1 PVT PUB 1
0166895 03/12/2001 GA 0.25 0 .3 M 02/23/2001 Fever and constant crying post vaccine, lasting 48 hrs. Test run all normal. 2/22/01 UC pending. Y 02/12/2001 02/12/2001 0 PVT PVT 1
0166896 03/12/2001 AZ 6.0 1 .3 M 02/23/2001 reports of pustulant sacks approx 20 on body. Y 07/25/1995 02/18/2001 2035 PVT UNK 1
0166897 03/12/2001 OK 42.0 42 F 02/22/2001 Pt reports fever, chills, sore arm, nausea, fever 102F, fatigue. Y 02/14/2001 02/14/2001 0 PVT PVT Xanax 1
0166898 03/12/2001 NY 2.0 2 .1 F 02/26/2001 Pt's mother reports post vaccine that evening injection site red 3" diameter, by morning the swelling encompassed the entire front of left leg. Y 07/18/2000 07/18/2000 0 PVT OTH Multivitamins, 1
0166899 03/12/2001 MI 65.0 65 F 02/21/2001 Pt reports swelling L arm pruritic 02/20/2001 02/20/2001 0 Abrasion R knee PVT UNK injury R knee abrasion Demerol, Codeine Cellulitis~Pneumo (no brand name)~~65.00~In Patient 1
0166900 03/12/2001 NJ 1.08 1 .1 F 02/27/2001 Vesicles noted, then pustules scabbed over, on face, 2 papules with erythema on hand. U 02/17/2000 02/23/2001 372 PVT PVT PPD 250611 lot # 1
0166901 03/12/2001 PA 0.2 0 .0 M 02/23/2001 3 hrs post vaccine pt started screaming inconsolably, lasted 1 1/2 hrs then was noticed to have mild jerking of head and one hand. Fever 101F for 24 hrs. Y 12/20/2000 12/20/2000 0 PVT PVT 1
0166902 03/12/2001 GA 4.0 4 M 02/26/2001 Pt's mother reports increased swelling, redness, fever 2 days post vaccine. N 02/23/2001 02/25/2001 2 PUB PUB Heart Murmur 1
0166904 03/12/2001 MA 33.0 33 F Vomiting, malaise, diarrhea Y 02/01/2001 02/01/2001 0 OTH PVT Allergic to some foods- oysters 1
0166905 03/12/2001 MA 42.0 42 F 02/16/2001 Severe nausea, stomach pain, headache. Y 12/21/2000 12/21/2000 0 OTH PVT 1
0166906 03/12/2001 AZ 15.0 F 01/18/2001 Pt's mother reports pt arm is red, warm and swollen post vaccine. Left arm is warm pink with induration approx 4" diameter. Y 01/10/2001 01/12/2001 2 PUB UNK 1
0166907 03/12/2001 WI 0.19 0 .2 F 01/22/2001 Per mother within 24 hrs pt developed fever of 103.9F. Pt developed episodes of limpness, paleness, cool to touch. Dr noted nothing unusual. Y Y 01/15/2001 01/15/2001 0 PUB PUB 1
0166908 03/12/2001 CA 1.4 1 .4 F 01/12/2001 6.5cm erythema around injection site with pain, although no induration, a hard center is felt. Y Y 01/10/2001 01/10/2001 0 PVT PVT 7 days prior fever, URI febrile seizures 1
0166909 03/12/2001 KY 1.5 1 .7 M 12/22/2000 Generalized chickenpox with fever 10 days post vaccine. Y U 12/11/2000 12/21/2000 10 Chickenpox PVT PVT Diluent Lot number 1079K 1
0166910 03/12/2001 NY 38.0 F 01/04/2001 Pt reports alopecia post Hep B vaccine. Y N PUB PVT 1
0166911 03/12/2001 AR 4.0 4 M 02/22/2001 Redness and swelling where DTAP was given. Pt given hydroxyzine syrup. Y Y 02/14/2001 02/16/2001 2 PVT UNK NONE NONE NONE 1
0166912 03/12/2001 PA 49.0 49 F 02/15/2001 Pt walked in on 2/14/01 for a BP check and I observed a localized reaction to pt's left deltoid region where a TD (Adult) had been given on 2/5/01. Erythema and warmness noted at region measuring 3 1/2" X 2 1/2". Injection area was also itchy. Pt states reaction site was worse prior but not observed by us. Instructed to use OTC analgesics and antihistamines. Y 02/05/2001 02/06/2001 1 NONE OTH OTH Maxide and KCL Foreign body in right leg Hypertension 1
0166913 03/12/2001 FL 6.0 6 M Rash at site; behavior changes. Y 02/15/2001 HBG-10.6; UA-WNL PVT PVT NONE NONE 1
0166914 03/12/2001 MA 5.0 5 F 03/01/2001 Upper left arm swollen, pink/blue in color about 6" plus discoloration at site and temperature, intermittently. No cough, no congestion. Reaction occurred within 24 hours. Ice pack and Tylenol were instructed as well as to call with any changes in area or condition. Y 02/27/2001 02/28/2001 1 PVT PUB NONE NONE Allergy to Augmentin 1
0166915 03/12/2001 SD 0.3 0 .3 F 02/17/2001 Baby cried, as if in pain, inconsolably for about 36 hours. During the crying spell, she hardly ate and barely slept, maybe 1 or 2 hours total for about 15-30 minutes at a time. The crying spell ended around 03:00 with her falling into a deep sleep for about 6-8 hours and then sleeping on and off for the remainder of the day, waking just to eat. There was swelling, redness and soreness at one of the injection sites for around 4 weeks. Her doctor dismissed both of these reactions and they do not appear in her records. She had the same reaction after her 1st set of inoculations, except no swelling. Y 01/27/1997 01/28/1997 1 PVT PVT 6 weeks premature at birth 1
0166916 03/12/2001 WI 1.5 1 .3 M 03/02/2001 Crying, irritable for several hours in the evening after shots given that day. Thought I'd call the doctor to see if reaction was normal. Autism Spectrum Disorder dx'd in 6/00. Showed slowing in speech development, motor skills all after vaccinations. U 04/03/1997 04/03/1997 0 PVT OTH Recovering from ear infection 1
0166921 03/12/2001 PA 1.3 1 .3 M 03/01/2001 Mom called and stated child has a couple of chickenpox on his stomach. U 06/27/1995 03/01/2001 2074 PVT UNK NONE NONE 1
0166924 03/12/2001 IN 33.0 33 F 02/26/2001 Local reaction with soreness, pain or tenderness, itching, swelling and warmth. Doctor prescribed Benadryl and it went away after 3-4 weeks of taking the Benadryl. Y Y 01/02/2001 01/03/2001 1 OTH OTH Toprol XL NONE High blood pressure 1
0166925 03/12/2001 WI 1.7 1 .7 M 03/01/2001 Local reaction with inflammation in left leg; possible early cellulitis. U 02/27/2001 03/01/2001 2 NONE PVT PVT SMZ/TMP given on 2/27/01 for illness. Cough NONE 1
0166926 03/12/2001 IN 8.0 7 M 02/27/2001 Pt received Hep-B about 08:30 or 08:45. He had not eaten breakfast. He declined offer of juice and crackers. Parent stated she would get him something to eat as they left the building. Child cooperative but apprehensive. Elementary school called about 12:30 and stated child had flushed, red cheeks, temperature of 99.4F. He became "limp" and complained of a sore throat. Parent came for child. States child fell asleep and needed 2 people to help with coat. Advised parent to check with MD or ER. On 2/28/01, parent reports child responded and improved after taking Tylenol yesterday afternoon. Did not seek medical evaluation. Child is in school this morning. Parent feels child possibly had a reaction to the Hep-B vaccine. She also noted his sister has been ill. Y 02/27/2001 02/27/2001 0 PUB PUB NONE NONE 1
0166927 03/12/2001 PA 57.0 57 F 02/28/2001 Office visit on 2/26/01, right deltoid red and warm to touch and painful. Seen by doctor and placed on Keflex 500mg X 10 days. Dx'd with allergic reaction secondary to TD vaccine. Y 02/23/2001 02/23/2001 0 PVT PVT Cat bite 1
0166928 03/12/2001 WI 17.0 17 F 02/28/2001 Fever, ache, chills, shortness of breath and fainting. Y 02/21/2001 02/21/2001 0 PUB UNK NONE 1
0166929 03/12/2001 AR 10.0 10 F 03/01/2001 On 3/1/01, had pain and rash at injection site, left deltoid; red area approx. 1.5cm wide and 3cm long. Denies SOB or hives or itching. Apply ice to area. If not relieved, try warm packs to area. U 02/27/2001 03/01/2001 2 NONE OTH OTH NONE NONE Birth mark on left arm 1
0166930 03/12/2001 OH 1.5 1 .5 M 02/20/2001 Large warm mass at site of injection; red and itchy. No red streak marks, no fever and no irritability; ambulates well. Y 02/19/2001 02/20/2001 1 NONE PVT PVT NONE NONE NONE 1
0166931 03/12/2001 MO 40.0 39 F 02/23/2001 The pt experienced rash and a few hives across chest approximately 30 minutes after receiving the Hepatitis A vaccine. Y 02/23/2001 02/23/2001 0 OTH OTH Paxil, HCTZ, Triam NONE swelling at site~Vaccine not specified (no brand name)~1~0.00~In Patient MO2001011 1
0166932 03/12/2001 IA 1.5 1 .5 F 02/22/2001 The pt woke the morning of 2/22/01 with local redness, swelling, not much discomfort at all. No limping and hasn't restricted her activities. No fever and no irritability. Y U 02/21/2001 02/22/2001 1 PVT PVT Chronic eczema 1
0166933 03/12/2001 KS 0.5 0 .6 F 03/01/2001 The vaccines were given at 3:00 pm and at 10:00 pm the child began to scream and cry inconsolably and did not quit until 2:00 am. The child had been given proper doses of Tylenol at proper intervals. Y 08/02/2000 08/02/2000 0 PUB PUB NONE NONE NONE 1
0166934 03/12/2001 CT 9.0 9 M 02/27/2001 The pt experienced generalized urticaria eruption approximately 6 hours post vax. The rash resolved over the next 12 hours. No fever, dyspnea or joint swelling. Benadryl was given by mouth for relief of pruritus. Y 02/19/2001 02/19/2001 0 NONE PVT PUB NONE NONE NONE 1
0166935 03/12/2001 OK 0.04 0 .0 M 02/26/2001 The pt experienced a red rash on face and trunk. Denies any respiratory distress. The mother was questioned about hive like appearance and she was unsure. Advised to call MD. Treated with Benadryl. Y 02/26/2001 02/26/2001 0 PUB UNK NONE NONE 1
0166936 03/12/2001 CO 1.0 1 .0 M 03/01/2001 The pt experienced an immediate red urticaria like appearance. Called the pt's home 2 hour later and the baby's father states the child is fine. U 02/28/2001 02/28/2001 0 NONE PUB PUB NONE mild gross motor delay, mild speech delay 1
0166937 03/12/2001 AZ 14.0 14 F 02/23/2001 The pt was diagnosed with atypical Guillain Barre syndrome. The mother did not pursue treatment as directed by MD. The mother states the child's problem is related to the injection. The pt also has difficulty walking. Y U 08/02/2000 12/19/2000 139 OTH PUB UNK 1
0166938 03/12/2001 TX 4.0 4 F 02/26/2001 The pt experienced a 3x4 cm sterile abscess to left deltoid. Y Y 02/19/2001 02/20/2001 1 PVT PVT NONE NONE 1
0166939 03/12/2001 MA 35.0 36 F 02/21/2001 02/12/01; received Hep-B vaccine, 1st dose. Five minutes, post vax, she became very itchy. Treated with Benadryl and told to continue series; no respiratory distress. Y 02/12/2001 02/12/2001 0 PUB UNK NONE 1
0166940 03/12/2001 MA 47.0 46 F 02/20/2001 On 2/7/01, received RabAvert, 2nd injection of a series of 3. On 2/12/01 (5 days later), she developed hives. Series discontinued; treated for hives. No respiratory distress. Y 02/07/2001 02/12/2001 5 PUB PVT Diluent/Chiron Behring/847011/IM/RA/1 previously 1
0166941 03/12/2001 MO 12.0 12 M 02/21/2001 Reported headache, throat ache and leg ache at vaccination. Elevated temperature (not sure how high). Tylenol was given at 16:00, 20:00 and at 02:30. Approx. 06:00, he had a seizure and was transported to ER. Discharged to home and is to follow-up with PMD on 2/23/01. Y Y 02/20/2001 02/20/2001 0 CT Scan; Blood work PUB PUB NONE MO2001010 1
0166942 03/12/2001 MO 1.0 1 .0 F 02/14/2001 Urticaria; no respiratory, nausea or vomiting or other problems. Mother gave Benadryl and hives were gone the next morning. Y 02/06/2001 02/06/2001 0 PUB PUB NONE NONE NONE MO2001007 1
0166943 03/12/2001 MO 33.0 33 F 02/14/2001 Client reports itching, redness, swelling and pain in left upper arm. U 02/12/2001 02/13/2001 1 PUB PUB Carafate, Zantac GI upset "1 week before vaccinations"-began taking Carafate and Zantac. MO2001008 1
0166944 03/12/2001 WI 2.0 2 .0 F 03/05/2001 Pt was in for 2 year check-up on 2/28/01 and received 4th DTAP in left thigh. On 3/1/01, returned to clinic with reddened raised area and was warm to touch. Y 02/28/2001 03/01/2001 1 PVT OTH NONE NONE NONE 1
0166945 03/12/2001 MD 3.25 1 .6 M Multiple lesions in various stages of papules, blisters and scabs over entire body including palate and genitals. U 03/04/1996 11/03/2000 1705 UNK UNK Allergies to dust mites, cats, pollens and grasses. 1
0166946 03/12/2001 FL 66.0 66 F 03/05/2001 Pain in neck and shoulders, primarily muscle pain; hip, knee and ankle pain. Y N 01/29/2001 01/31/2001 2 PVT PVT Caltrate 60, Lorazepam, Centrum, Procardia XL, Ranitidine History of osteoarthritis of left knee; bleeding ulcer, ? 1
0166947 03/12/2001 NC 23.0 22 F 03/06/2001 Paleness, weakness, fast heart beat and dizziness within 30-45 minutes, post vax. Y 03/05/2001 03/05/2001 0 NONE PUB PUB Ortho Tri-cyclen NONE Allergy to PCN 1
0166948 03/12/2001 MI 1.5 1 .5 F 02/28/2001 Temperature 103F (ax); measles type rash covering whole body; coryza and cough. Y U 02/16/2001 02/26/2001 10 CBC-WNL PVT PUB NONE NONE 1
0166949 03/12/2001 PA 2.0 2 .2 M Local swelling on right thigh; no respiratory distress; redness and swelling on palms and soles. No treatment needed except ibuprofen for pain. Y Y 02/22/2001 02/23/2001 1 NONE PVT PUB NONE Alveolar rhabdomyosarcoma left orbital 1
0166950 03/12/2001 MT 32.0 32 F 02/27/2001 Pt developed hives and itching post vaccine. Y Y 02/23/2001 02/23/2001 0 PVT PVT Prozac 1
0166951 03/12/2001 GA 5.0 5 M 02/26/2001 3x4cm erythematous, swelling at injection site. Y 02/20/2001 02/20/2001 0 PVT PVT 1
0166952 03/12/2001 AK 42.0 42 F 02/23/2001 Pt reports pain at injection site. U 02/09/2001 02/22/2001 13 PVT PUB Insulin, Prozac, Neurantin, Prilosec, vioxx, Vicodin, FeS04 Musculoskeletal ? DM type 1, with peripheral neuropathy. 1
0166953 03/12/2001 WI 6 U Pt developed fever 103F post vaccine. Pt reports fever, nausea, vomiting. Dx with gastroenteritis. 1/28 noted increased redness and swelling. Localized reaction to DPT or Hepatitis B VS cellulitis, child limping, reddened ecchymotic area surrounding injection site. Warmth. Y U 01/26/2001 02/27/2001 32 PVT PVT 1
0166954 03/12/2001 TX 1.0 1 .0 F 02/28/2001 Mother reports post vaccine pt was fussy, low grade fever, later fever of 104F with diffuse rash all over body of erythematous morbilliform spots. Y Y 02/15/2001 02/22/2001 7 unsure what labs were run, values given only. PVT PVT 1
0166955 03/12/2001 NY 10.0 10 F 03/01/2001 Reports large irregular erythema area around injection site. Y 02/28/2001 02/28/2001 0 PVT UNK Allergy to Amoxicillin 1
0166956 03/12/2001 UT 1.0 1 .0 F 01/18/2001 Mom reports pt had high fever and then broke out in rash, rash eventually covered entire body. Y 01/08/2001 01/15/2001 7 PUB PUB UT010701 1
0166957 03/12/2001 UT 61.0 61 F 02/15/2001 Pt reports itching at injection site, felt hot burning sensation, tightness, swelling in arm , shoulder and neck pain. Decreased ROM. Y Y 02/07/2001 02/07/2001 0 PUB PVT Estrogen/Progestogan patch, Prevacid Allergy to Penicillin UT012502 1
0166958 03/12/2001 NJ 6.0 6 F 02/28/2001 Pt developed edema post vaccine, pt was hypertensive and had proteinuria. DX nephrotic syndrome. U 01/03/2001 01/03/2001 0 PVT PVT NJ20016 1
0166959 03/12/2001 NJ 1.25 1 .2 M 03/02/2001 Mother reports child had fever of 104F, irritable and crying. On 3/3 dx with ear infection. Y Y 02/21/2001 03/02/2001 9 PUB PUB NJ20015 1
0166960 03/12/2001 NH 0.4 0 .4 M 03/07/2001 Mother reports baby lethargic, wouldn't wake up, body limp. Y 12/06/2000 12/06/2000 0 PVT PUB NH0107 1
0166961 03/12/2001 NH 0.4 0 .4 M 03/07/2001 Hives started on face moved to entire body. Y 12/16/2000 12/16/2000 0 PVT PUB NH0106 1
0166962 03/12/2001 TN 55.0 55 F 02/14/2001 Pt reports joint pain and stiffness in wrists, ankles and fingers. 01/22/2001 01/26/2001 4 PUB PVT Synthroid, Estrole, calcium Allergy penicillin, hashimoto's, thyroiditis 1
0166963 03/12/2001 SD 1.6 1 .6 M 01/04/2001 Father reports child's leg became swollen with hard red swelling from knee to hip. Father states seems tender. Y 12/14/2000 12/14/2000 0 PUB PUB SD1001 1
0166964 03/12/2001 SD 2.0 3 F 09/26/2000 Two sisters received varicella vaccine on 8/25/00. Another sister developed chicken pox. Y 08/25/2000 09/20/2000 26 PVT PUB NONE NONE NONE SD000015 1
0166965 03/12/2001 SD 3.0 3 M 09/07/2000 Mother reports pt's arm became red hot, swollen, had slight fever. Reaction to vaccine. Sore arm. Y Y 09/06/2000 09/07/2000 1 UNK UNK TB Conn Lot#C0048AA,SQ, R forearm. SD00014 1
0166966 03/12/2001 SD 0.2 0 .2 F 09/10/2000 Persistent severe crying times 3 days. Y 09/06/2000 09/07/2000 1 PVT PUB ear infection SD00013 1
0166967 03/12/2001 SD 0.3 0 .4 M 09/08/2000 Pt very fussy for 1 week, screaming 15 min at time 2 days. Loss of appetite, spitting up, tired. Y 08/23/2000 08/25/2000 2 PUB PUB mother wonders if eggs allergy SD00012 1
0166968 03/12/2001 SD 2.0 2 .1 F 08/17/2000 Local reaction on right thigh area approx 2" diameter with erythema, mild induration, and warmth. Increased swelling. Older sibling died 1 day post vaccine at 2.5 mo of age. Pt monitored for 1 hr in ER, local reaction, sent home. Y Y 08/17/2000 08/17/2000 0 PUB PUB ~Vaccine not specified (no brand name)~1~2.50~In Sibling SD00010 1
0166969 03/12/2001 SD 1.4 1 .4 M 10/03/2000 Pt has blistery rash over entire body, scalp,face, consistent chicken pox rash. Y 08/14/2000 09/10/2000 27 PUB PUB SD00009 1
0166970 03/12/2001 SD 5.0 5 M 08/23/2000 Mother reports child has a purplish swollen arm, itchy area. Y U 08/07/2000 08/14/2000 7 OTH UNK SD00008 1
0166971 03/12/2001 SD 18.0 F 07/10/2000 Pt reports 24 hrs post vaccine developed severe headache and aching all over, next day pain all over her body temp 100F, next day feeling weak, loss of appetite. Y 07/10/2000 07/11/2000 1 PUB PUB SD00007 1
0166972 03/12/2001 SD 0.25 0 .3 F 04/18/2000 Mother reports baby has rash on stomach, then traveled over entire body. Dr noticed erythematous rash on different part of body, no fever. Y 04/11/2000 04/16/2000 5 Strep screen negative, CBC normal PVT PUB Jaundice in newborn SD00004 1
0166973 03/12/2001 CA 4.0 4 M 02/28/2001 redness injection site, hot to touch, inflammation. Y 02/26/2001 02/27/2001 1 PVT PVT PPD,Connaught, lot 00390P,L arm 1
0166974 03/12/2001 WA 4.0 4 M 03/02/2001 Mother reports 2.3 red lesion appeared 2 days post vaccine at injection site. Erythema at injection site. Y 02/13/2001 02/25/2001 12 PVT PUB Zyrtec Allergies- nasal congestion 1
0166975 03/12/2001 MI 59.0 60 M 02/28/2001 Itchy rash Locally, left arm. Y 02/13/2001 02/14/2001 1 PVT PVT 1
0166976 03/12/2001 MD 2.0 2 .1 M 03/04/2001 Injection site swollen, hot and red 3" circle around site. Y U 02/20/2001 02/21/2001 1 PVT OTH Rocephin Hospitalization for bronchospasm strep throat. ~DTP (no brand name)~4~1.60~In Sibling 1
0166977 03/12/2001 FL 30.0 30 F 03/05/2001 At the time of vaccination, the pt reported that she was not pregnant. At a later date, she reported that she was pregnant. "Death of child" was noted. In 10/00 an autopsy was performed on a male child with no reported genetic abnormalities. It was reported that the doctor did not have any information on the child or fetus and does not know if this was a miscarriage, stillbirth, or death after delivery. Additional information has been requested. Follow up on 06/29/2001: "Lot number for vaccine 1 is not provided." Y U 06/06/2000 10/01/2000 117 OTH OTH UNK pregnancy WAES01021410 1
0166979 03/12/2001 KY 0.6 0 .6 F 03/07/2001 A mother reported that her 7 month old daughter received her 2nd dose of Prevnar, as well as, Diphtheria, Tetanus and Pertussis, and Hep B vaccines on 12/12/00 and reportedly within 2 days, developed two "very bad" ear infection, a "bad" stomach virus and pink eye. She was hospitalized due to dehydration on 12/31/00 and was discharged on 01/01/01. The patient had been "sick on and off" for 2 months; she recovered. The reporter indicated that she did not want the physician contacted for additional info. Y 2 Y 12/12/2000 12/31/2000 19 UNK PVT PVT NONE NONE UNK HQ8031606MAR2001 1
0166980 03/12/2001 DE 40.0 41 M 03/05/2001 On 02/21/00, this patient was diagnosed with severe idiopathic cardiomyopathy. He had an "URI" approximately 3 weeks prior. (The patient understands idiopathic but believes this can be due to the vaccine). FU indicates onset of cardiomyopathy approximately 2/1/00. Y Y N 11/01/1999 OTH UNK NONE URI 3 weeks prior to vaccine. 1
0166982 03/12/2001 1.25 1 .3 M 03/08/2001 Information has been received from an investigator regarding a 15 month old male who received his 1st dose of Prevnar as part of the part of a post marketing safety trial on 6/29/00. The next day, the pt was seen in the clinic for angioedema and urticaria. He recovered. Angioedema is considered "Medically Important". Both the investigator and medical monitor agree that these events are probably related to vaccine administration. Y Y 06/29/2000 06/30/2000 1 NONE UNK UNK UNK UNK HQ8000806MAR2001 1
0166983 03/12/2001 4.0 4 F 03/08/2001 Information has been received from an investigator regarding a 4 year old female who received her 1st dose of Prevnar as part of a post marketing safety trial on 5/19/00. On 5/22/00, she was seen in the clinic for angioedema and urticaria. She recovered. Angioedema is considered "Medically Important". Both the investigator and medical monitor agree that these events are possibly related to vaccine administration. Y 05/19/2000 05/22/2000 3 NONE UNK UNK UNK UNK HQ8002206MAR2001 1
0166984 03/12/2001 MA 1.7 1 .7 F 03/02/2001 Vaccine received on 2/27/01 and had 2.5 cm red area with induration. Temperature was 104F on 3/2/01 and then 100F (R), that day. Treated with Tylenol and cold compresses to the area. No more DTAP. Y Y 02/27/2001 03/02/2001 3 PVT PUB 1
0166986 03/12/2001 PA 0.9 0 1 F 03/05/2001 Child developed maculo-papular rash over right arm, abdominal wall and right side going up towards chest. This happened, 12 days, post vax. Treated with Amoxicillin. Y 01/19/2001 01/31/2001 12 PVT PVT 1
0166987 03/12/2001 AZ 0.25 0 .3 M 03/02/2001 On 2/28/01, post vax, a hard, raised lump appeared immediately on right leg; also noted a red area approx. 1/4 wide which appeared on left leg. Spoke to mom on 2/29/01 and child is afebrile and moving both legs WNL and "raised" areas remain with no redness or warmth. Y 02/28/2001 02/28/2001 0 PUB OTH NONE NONE NONE AZ0109 1
0166988 03/12/2001 AZ 0.6 0 .6 F 02/23/2001 Child ran a fever (not taken) on the evening of 2/21/01. No fever, as of 2/22/01; right leg with 2 areas edematous and red. On 2/23/01, had slight edema that remained on left leg; no redness or warmth and was afebrile. Y 02/21/2001 02/21/2001 0 PUB OTH NONE NONE AZ0108 1
0166989 03/12/2001 MS 1.4 1 .5 M 03/01/2001 High-grade fever of 103F, 1 hours, post vax, and crying a lot. U 02/28/2001 02/28/2001 0 NONE PVT PUB Furoxone Giardiasis NONE MS01008 1
0166990 03/12/2001 MN 3.0 3 F 02/23/2001 Mom informs us that pt developed a temperature of 104F on the evening of 2/22/01. Had a seizure that required mouth to mouth and ambu bagging. Reports stable HR this morning. Y 02/22/2001 02/22/2001 0 PVT UNK Robinul; Atrovent; Prilosec; Bactroban ointment; Phenobarbital; Milk of Magnesia; Centrum vitamins; Xopenex; Eryped; Pulmicort; O2 Recent tracheobronchitis/sinus disease; recurrent aspiration disease secondary to inadequate swallow and cough with the emergence of stimulus induced cough; Chromosome deletion syndrome of 1Q with multiple congenital anomalies including: polyhydramnios; double aortic arch; hydrocephalus; patent ductus arterious; h/o abscess of the coccyx, no tethered cord was noted; duplication of thoracic vertebra; stenotic left tear duct; s/p hyaline membrane disease with 10 days of mechanical ventilation and 2 weeks of oxygen; absence of the corpus callosum; s/p prenatal strokes; arrested brain development; cortical atrophy; EEG-abn; h/o seizures; UTI; GERD treated with g-tube and j-tube placement; ectopic anus with constipation; profound mental delay with defects in vision and hearing; hypoactive bowel under treatment. 1
0166991 03/12/2001 NC 2.0 2 .2 M 02/21/2001 Fever of 104F, 30 minutes, post vax. Was dizzy, weak and had a runny nose. High fever of 104F persisted for 24 hours after event. U 02/20/2001 02/20/2001 0 NONE PUB PUB NONE NONE NONE NC01022 1
0166992 03/12/2001 NC 0.5 0 .5 M 02/20/2001 Quarter-sized erythema at injection site. Seen 1 day, post vax, with small (.4cm) hard center, sensitive to touch. No fever. Advised to put cold compresses on as tolerated. Y Y 02/19/2001 02/20/2001 1 NONE PVT PVT NONE NC01023 1
0166993 03/12/2001 NC 1.4 1 .3 M 03/01/2001 Vomiting and diarrhea and low-grade fever with hives over trunk and extremities and ear lobes. Onset 12 hours, post vax. Treated with Pedialyte and bland diet. Return if rash progresses treat with Benadryl. Y 02/28/2001 03/01/2001 1 NONE PVT PUB NONE NONE Prematurity; jaundice NC01024 1
0166995 03/12/2001 MN 1.0 1 .0 M 02/28/2001 7 days, post vax, pt had high fever (max 105.2F) with macular rash over the torso. Rash has been present for 7 days. He did have streptococcal pharyngitis and treatment with Amoxicillin 1 month prior to reaction. Still has macular rash. Y Y 02/19/2001 02/21/2001 2 WBC-7,900; Seg-44; Lymphs-44; Mono-7; Reactive lymphs seen. PVT UNK NONE NONE 1
0166996 03/12/2001 KY 2.0 2 .8 M 03/02/2001 Pt was seen for well child visit. No other vaccines given. No medication given, 3 days prior or after vaccine. No change in diet either. Covered in hives and severe swelling. Eyes swelled shut. No respiratory problems or other reactions. Treatment with Benadryl; 2 tsps every 4 hours for 3 days. Y Y 02/19/2001 02/20/2001 1 NONE PVT PVT NONE NONE NONE 1
0166997 03/12/2001 NJ 66.0 64 M 03/05/2001 Nausea, eye sight fluctuations, rash, headache, insomnia, tingling of hands & feet, Long bones in arms & legs are so sore they hurt when touching each other. Ear problems with loud noises. I now have 6 plugged arteries. A follow up report received 10/31/2001 adds: Pt's attorney instructed him to call VAERS in F/U to his previous report. Pt's symptoms persist in terms of difficulty focusing with his eyes, sensitivity to sound, pain in bones of arms and legs, and insomnia due to discomfort. No prescription or OTC medications have been effective. About 6 months ago he had 3 stents placed for the previously reported coronary artery occlusions. His cardiologist stated that pt's eye, ear and bone pain problems were not related to his cardiac problems. Pt's PMH is significant for coronary bypass surgery approx 1991 and treatment with Prednisone for 7-8 months due to symptoms of Lyme disease (fatigue, pain, bulls-eye rash) in 1991. Pt states his condition then was not diagnosed as Lyme disease and his blood tests were negative. However, the tests were unsophisticated at that time according to the pt and it is now presumed he indeed had Lyme disease. He states he fully recovered at that time. Currently he takes large amounts of vitamins and minerals and, "something for sleep which does not help past 1-2 hours". Y N 05/05/1999 05/06/1999 1 X-rays, MRI, Ultrasound, cat scan colonscopy/ upper GI with small bowel/protein profile for cancer/numerous blood tests/hearth cath/complete physical, etc. PVT PVT sinusitis 1
0166999 03/12/2001 36.0 36 M 07/19/2001 Pt reports arthralgia. The most recent info was received from the infectious disease specialist on 04/16/2001. This physician considered the arthralgia to be moderate in intensity and possibly related to LYMErix administration. The arthralgia persisted as of 03/13/2001. As of 03/28/2001, the pt's serologies have continued to remain negative. The adverse event of arthralgia does not meet serious criteria, but is being submitte as an expedited report by special FDA request per the June 28, 2000 letter. Y N 05/10/1999 06/16/2000 403 OTH OTH Prostatitis, gastroesophageal reflux disease, hypertension, arthralgia of the fingers, toes and both knees (prostatitis) 20010059771 1
0167000 03/12/2001 PA 47.0 47 M 03/07/2001 The pt received the 1st and 2nd injections of Lymerix in 8/99 and 9/99. The pt presented to his PMD on 1/31/00, approx. 4 months following receipt of the 2nd injection, with a 3 week history of wrist and ankle pain and a painful Achilles tendon. His pain was worse in the AM and relieved with Naprosyn. The pt also reported stiffness and swelling in his fingers for 1 week; the stiffness was worse at night. On physical exam, the pt had free range of motion with pain on flexion and extension of the ankles. The physician's assessment was tendonitis and "? arthritis". The physician prescribed Naprosyn 500mg twice daily. The pt was been by his orthopedic surgeon on 2/7/00, "for both wrists and both heels." The orthopedic surgeon noted, "He has developed some symptoms in his wrist and hands of tightness, burning, tingling, awakens him at nighttime, difficulty when he shakes hands, occasional radiation proximally in the forearm." On physical exam of the left wrist, the pt had "tenderness dorsally over the scapholunate ligament (positive Phalen's). There is no dorsal tenderness on the right, but Phalen's is very positive. He has tenderness over the carpal canal. Both heels have been painful along the Achilles. He has had trouble with this off and on for many years. He had a very pronounced pes plano valus deformity. He has got palpable nodules in the Achilles tendon proper, but no large degenerative nodules with any erythema or warmth." The orthopedic surgeon's impression was "Chronic Achilles tendonitis bilaterally, median nerve compression syndrome right greater than left." He was treated with wrist splints to be worn while he was doing desk work, naproxen and orthotics. The pt presented to his PMD on 2/28/00 with a chief complaint of joint pain, which was increasing and "has moved to all joints, but spares the hips and back." The pt also reported "some muscle pain, some fatigue and ? fevers-felt hot." On exam, physician's assessment was joint pain and prescribed Vioxx and extropropoxyphena/paracatamol. The dx was recorded as "?RA" and was referred to a rheumatologist. The pt saw this MD on 3/14/00 and dx was "714.0 Rheumatoid Arthritis". The pt was treated with prednisone, Vioxx, methotrexate and Plaquenil. On 2/2/01, the pt presented to his PMD with a 2 month history of a lump near his navel. It was irritated by his belt and sometimes painful. The MD's assessment was "umbilical hernia-small, no evidence of incarceration." The pt was referred to a general surgeon. The most recent information received on 2/28/01, did not provide an outcome for the reported events. Y U 09/01/1999 01/01/2000 122 X-rays of wrists-showed "some mild degenerative changes"; Sed rate-44mm/hr; quantitative RA factor-307 iu/ml; antinuclear antibody titer was-neg; Lyme IgG and IgM by Western Blot analysis-neg; Testing for HLA-DR4 on 3/17/00-positive. OTH OTH Acromioclavicular joint arthritis (1996), allergic rhinitis, allergy desensitization, arthroscopic surgery left ankle (1996), left knee (1993), asthma, bronchitis, carpal tunnel syndrome (1990), cervical radiculopathy (1997), Cervical spine degenerative disc disease (1997), chronic archilles tendonitis and sinusitis, degenerative changes in left knee (1994) HLA-DR4 pos, left chondromalacia patella (1993), left ligament tear (1993), lumbosacral sprain with possible deg. disc disease (1993), non-specific ST-T wave changes (1998), plantar fasciitis, pneumonia proctitis (1990), right elbow epicondylitis (2/99) UPI, Cervical spine X-rays 4/15/97-severe deg disc disease at C5-C6 with marked bilateral foraminal compromise, etc. 20010057391 1
0167001 03/12/2001 UT 10.0 10 M 12/11/2000 Immediately, post vax of his daily injection of Humatrope, he had a seizure which lasted approx. 45 seconds. Mother stated "he went rigid, held his breath and went blue". No previous history of seizures. No reaction with previous doses of Flu or Humatrope. Complained of headache the next day. Y 12/05/2000 12/05/2000 0 PUB PVT Humatrope (daily by injection) NONE UT002729 1
0167002 03/12/2001 GA 42.0 41 F 03/09/2001 Rash with induration; evaluated by MD and was given Benadryl and told not to get vaccine again. Y Y 11/09/2000 11/09/2000 0 OTH PVT NONE 1
0167003 03/12/2001 CA 62.0 62 F 02/23/2001 Client complained of hair loss and states the hair loss occurred after the 2nd dose of Hep-B vaccine. U 10/05/2000 12/01/2000 57 NONE UNK UNK NONE NONE 1
0167004 03/12/2001 NY 1.08 1 .1 F 02/15/2001 VZV given on 1/8/01. Pt presents on 1/29/01 with a rash consistent with mild varicella. No fevers; blanching, erythema, circular lesions 2-7mm macular, some papular and a few with vesicles over trunk and extremities. Spares palms, soles and oral cavities. U 01/08/2001 01/27/2001 19 NONE PVT PVT Diluent for VZV/MMR/MSD/0303K; Amoxil 1/22/01 X 10 days NONE NONE 1
0167005 03/12/2001 LA 48.0 48 F 02/05/2001 Left arm and shoulder area got extremely sore and was unable to lift without pain. Could not lift above my head at all. Today, still somewhat sore and area of shot site discolored. Y 10/02/2000 11/02/2000 31 PVT PVT NONE NONE 1
0167006 03/12/2001 SC 4.0 4 F Fine rash on back of arms, few spots on back of legs; no itching. Mom to get OTC Benadryl and take to PMD. Y 02/07/2001 02/07/2001 0 PUB UNK NONE NONE NONE SC0108 1
0167007 03/12/2001 SC 17.0 17 F 02/15/2001 Shot given yesterday. Mother called clinic this AM to report that child is in bed sick with nausea (no vomiting) and headache. Mother reports that child had similar reaction after 2nd Hep-B. U 02/14/2001 02/14/2001 0 PUB PUB According to mother, pt is schizophrenic; has heavy menstrual bleeding X 2 weeks. SC0107 1
0167008 03/12/2001 WA 0 .0 F 03/05/2001 Rash developed on abdomen post Hepatitis B vaccine. Y U 03/03/2001 03/03/2001 0 PUB PUB 1
0167009 03/12/2001 OH 0.25 0 .3 F 03/12/2001 Mother reports post vaccine baby has been crying all day, no fever, no seizures. Y 02/28/2001 02/28/2001 0 PVT PVT 1
0167010 03/12/2001 VA 4.0 4 M 03/02/2001 Report of local reaction, left leg plus edema, redness, pain on knee .Extremity warm by touch. Seen by physician. Y 02/28/2001 03/02/2001 2 MIL MIL PPD/Past/C0578A2/1 1
0167011 03/12/2001 MD 1.0 1 .0 M 03/05/2001 Immediate urticaria on side of L arm injection site. Y Y 03/01/2001 03/01/2001 0 PVT PVT NONE NONE 1
0167012 03/12/2001 NC 4.0 4 F 24 hrs post vaccine injection fever of 102F, baseball size redness, swelling of R thigh. Treated with Augmentin for possible cellulitis. Y Y 02/28/2001 03/01/2001 1 PVT PUB 1
0167013 03/12/2001 FL 1.0 1 .0 F 03/12/2001 Blanching macular rash with mild swelling and tenderness at injection site. 02/21/2001 02/25/2001 4 PVT PVT dry cough 1
0167014 03/12/2001 CA 9.0 9 M 02/21/2001 While getting up after receiving shots, the pt fell and hit left eye on counter. The pt had laceration to left upper eyelid was diaphoretic and dizzy. Y Y 02/12/2001 02/21/2001 9 OTH OTH The pt received IPV on same day with a manufacturer of Connaught and Lot number of R1345. The pt also had a PPD on the same day. NONE NONE 1
0167015 03/13/2001 FL 1.6 1 .6 F 06/21/2000 This infant had hives all over her body, 6 days after her shots. Y Y 06/14/2000 06/20/2000 6 NONE PUB UNK NONE NONE NONE FL00026 1
0167016 03/13/2001 FL 4.0 4 F 06/23/2000 This child had redness, warmth, size 5 x 5 cm at the left deltoid area. Non tender, no fever. Over the counter Benadryl, topical Cortisone cream. Y 06/21/2000 06/23/2000 2 NONE PUB PUB NONE NONE FL00025 1
0167017 03/13/2001 FL 5.0 5 F 07/06/2000 A nurse stated that this child presented in there office on 06/29/00, with severe large red welts on her upper right arm. Had also gone to the hospital ER on 06/28/00. Y U 06/27/2000 06/28/2000 1 PUB UNK NONE FL00024 1
0167018 03/13/2001 FL 2.25 2 .3 M 06/28/2000 This child had inconsolable crying for 12 hours. He napped when tired, crying while awake. The doctor recommended Advil and Tylenol to the mother (per mom) the child is to be seen if no improvement. Y 06/28/2000 06/28/2000 0 PUB UNK NONE NONE FL00023 1
0167019 03/13/2001 FL 2.0 2 .5 F 06/01/2000 This child's left arm was red and swollen from 1" above the elbow to the shoulder, temp 100.2 (ax). Y Y 05/30/2000 05/31/2000 1 NONE PUB PUB NONE NONE FL00022 1
0167020 03/13/2001 FL 40.0 40 M 06/12/2000 This patient complains that since 01/14/00, he has had pain to the deltoid area. Pain is worse in the AM. The pain goes from the shoulder to the fingers. The patient uses pain cream and finds relief sometime all day. U 01/14/2000 01/15/2000 1 PUB UNK NONE NONE FL00021 1
0167021 03/13/2001 FL 45.0 45 M 04/11/2000 This patient had extreme redness, swelling, heat and pain at the injection site. She also had a fever of 103 F, weakness, chills, , dizziness, nausea, / disorientation. The patient desires to report events so manufacturer will be aware. Y 03/01/2000 03/01/2000 0 PUB PUB NONE Allergic to Penicillin, and Sulfa. FL00020 1
0167022 03/13/2001 FL 1.3 1 .3 F 05/26/2000 This patient received V2V on 05/09/00. She was seen in the clinic on 05/18/00 with rash secondary to Varicella injection. Y 05/09/2000 05/14/2000 5 NONE PUB PUB NONE NONE NONE FL00019 1
0167023 03/13/2001 FL 12.0 12 M 05/10/2000 This patient's mother states the child developed a low grade fever after 24 hours. Then developed repetitive hand movements after 10 days which lasted "quite a while". The child did not seem to be aware of hand movements. He kept a fever 3 weeks and had a loss of appetite. This client was not seen by a physician but he obtained a medical exemption for Hep B from a cousin who is a physician. U 02/22/2000 02/23/2000 1 PUB UNK NONE NONE FL00017 1
0167024 03/13/2001 TX 0.8 0 .6 M 08/31/2000 This infant received vaccine at 9:30 AM, cried non stop from 12:30 -2:45 PM; per mom he was inconsolable. Seen at 4:50 PM and fussy, but exam was within normal limits. Y Y 08/29/2000 08/29/2000 0 NONE PVT PUB NONE NONE NONE 1
0167025 03/13/2001 NC 4.0 4 M 02/10/2000 This patient's mother noticed that the patient reported left arm still hurts, upon exam the left shoulder was red, warm, and swollen (02/10/00). The patient had not reported any problems prior to that. No fever. Y 02/07/2000 02/10/2000 3 NONE PUB PUB NONE NONE NONE NC00010 1
0167026 03/13/2001 NC 5.0 5 F 05/25/2000 This child had redness, warmth, and swelling to the leg. Y 05/23/2000 05/24/2000 1 PVT PUB NONE NONE NC00035 1
0167029 03/13/2001 IA 40.0 40 M 02/25/2001 This patient was in hypotensive shock: hypotension 124/96 - 70/40, Pulse 82/46, diaphoresis, pallor, bradycardia. Treatment with IV fluids. A question of 2 degree vasovagal syncope. Y Y Y 02/25/2001 02/25/2001 0 PUB UNK Laceration to right hand Allergy: codeine, status/post aortic valve replacement 10 years ago. 1
0167031 03/13/2001 FL 0.1 0 .1 F 03/02/2001 Pt was seen on 12/5/00 for 1 month well check-up and given 1st Hep-B shot. Within hours, post vax, mother noted irritability and "paleness". Pt vomited on/off for 2 days and returned to our office on 12/8/00. The pt was found to have supraventricular tachycardia and shock. Transported to ICU where she was intubated and converted. Y Y Y 5 Y Y 12/05/2000 12/08/2000 3 PVT PVT NONE NONE 1
0167032 03/13/2001 FL 1.0 1 .0 F 03/07/2001 Child became chronically constipated; odd behaviors began. Child withdrew socially and lost all communication skills and eye contact. 60 day follow up states the pt still has mercury poisoning and showing signs of brain immaturity. Y Y N 03/13/1998 03/20/1998 7 PVT UNK NONE Ear infection 2 weeks prior. 1
0167033 03/13/2001 CA 40.0 39 M 03/08/2001 Report 2001003784-1 described possible progressive small fiber neuropathy in a 40 year old male who received Hep B vaccine recombinant (Engerix-B) for prophylaxis of Hep B. This report was received from the vaccinee and has been verified by a physician. On 05/05/99, and 06/11/99, the vaccinee received his first and second dose of Engerix-B, respectively. Six days after receiving the 2nd dose of Engerix-B, on 06/17/99, the vaccinee experienced pain, burning, and numbness on all limbs, trunk, and face. The neurologist considered these events to be severe in intensity. The neurologist made a diagnosis of possible progressive small fiber Neuropathy in 01/00, and treated the patient with gabapentin (Neurontin), and hydrocodone bitartrate/ paracetamol (Lortab). He was also taking paracetamol / oxycodone hydrochloride (Percocet). On 03/06/01, the neurologist reported that these adverse events were disabling / incapacitating and possibly related to Engerix-B. However, the neurologist also stated "unclear if related". As a result of the information received on 03/06/01, this report has been reclassified as serious, unexpected. As of 03/01, the outcome of the adverse events was resolved. The follow up received on 5/31/01 states pt medical history also included numerous motorcycle accidents and broken bones from 1975-1980. Other concomitant medications included Claritin, Acyclovir, multivitamin, Lariam, and Ambien. The pt reported occasional marihuana use. His family hisotyr was remarkable for Parkinson's disease. The vaccinee experienced numbness in his left great toe. The numbness proceeded to involve both legs from the knees down. He then developed tremors on twitches in his arms and legs, which he considered to be muscle spasms. Following that he experienced burning of both arms and legs, chest and back. He developed an intermittent rash over his joints, "which was burning and painful. Additionally, he experienced "severe" fatigue and weight loss. He was treated with a one-week course of prednisone without improvement. 8/14/00: Neurology referral letter: electrolyte analysis, creatinine, creatinine phosphokinase, all were normal or negative. While taking B6 supplements, his b6 level was elevated at 90. After discontinuation of supplements, the B6 level was normal at 39.5. Cerebrospinal fluid analysis performed in December 1999 revealed one white blood cell, 402 red blood cells, glucose 66, protein 52, negative VDRL, negative CRAG, and a normal IgG index. CSF obtained on 4/21/00 showed 3 WBC, 0 RBC, protein 44, glucose 64, non-reaction VDRL, IgG index 0.8, and negative oligoclonal bands. Sjogren's evaluation by an ophthalmologist was negative. Qualitative sensory testing was negative. Review of system was remarkable for five out of six since symptoms for dry eyes and mouth. The pt was "mildly unsteady with tendem gait. On sensory examination, proprioception, touch and vibration have normal thresholds in the hands and feet. Pin and temperture are decreased to the knees bilaterally, while touch, vibration, and proprioception ahve normal thresholds in the hands and feet. Rhomberg sign is negative. The neurologist's impression was "clinically he appears to have a progressive small fiber neuropathy, however documentation of the neuropathy with testing and its etiology remain clusive." 8/22/00-skin biopsy report: epidermal nerve fiber density is within a normal range at all three sites (proximal thigh, distal thigh, distalleg); therefore, there is no definite evidence of a neuropathic process affecting small caliber nerve fibers. The nerve fiber swellings noted at the distal leg site are, however, suggestive of early nerve fiber degeneration and depending on the pt's clinical progression. A repeat biopsy in 3 to 6 months' time may be useful. 1/9/01-pain center evaluation. At this time, the pt reported some yellowing of his skin, "which may or may not be related to excessive carotene intake," and also abdominal pains with nausea, vomiting, and diarrhea. He reported that he occasionaly had dark, foul-smelling urine. The pt described his pain as shotting and stabbing, with a burning component. He described it as being constant, with frequent flares. He "described his sleep habits as poor secondary to his mind being somewhat over-stimulated at night." He was unsable to participate in his usual recreational activities, including mountain biking and basketball. He reported that MRI of the head, cervical, thoracic, and lumbar areas, perfomred one year prior, were negative. The pt had trials of Elvail and Tegretol, which exacerbated his symptoms. Acupuncture, vitamin B6, Zoloft, amantadine and ibuprofen were all ineffective. He noted that being in a hot tub gave him some temporary relief. The pt also found physical therapy to be somewhat effective. At the time of the evaluation, his medication regimen included Lidodera patch, Neurontin 500mg five times daily, Wellburtin SR 100mg twice daily, Ambien 20mg at hour of sleep, Lortab 7.5/00mg one tablet four times daily, and acyclovir 200mg daily. he also recommended tyring Topamax, Gabitril, or mexilatine for pain relief. The most recent info was received from the neurologist on 5/31/01. The latest record forwarded was dated 2/12/01 and indicated that the pain was ongoing. The record dated 2/1/01 indicated that the pain, tremulousness, fatigue, and episodes of confusion were ongoing and disabling. The outcomes of the rash, weight loss, yellowing of the skin, abdominal pains, nausea, vomiting, diarrhea, dark urine, and foul-smelling urine werre not provided. Y Y N 06/11/1999 06/17/1999 6 CBC; BUN; ESR; ANA; ANCA; DSDNA; SPEP; Liver function tests; HglAC; Hepatitis serologies; HTLVI and HTLVII; IFEC; UPEP; UA; Sjogren's antibody; 24 hour urine heavy metal screen; B12 level: Spinal fluid analysis; EMG/nerve conduction studies, fat pad biopsy, "QST" and skin biopsy for small fiber neuropathy. All test results were normal except for the skin biopsy which was reported as "abnormal". OTH OTH Claritin, Acyclovir, multivitamin, Ambien, Lidoderm, Lariam Seasonal allergies; Herpes NOS. 2001003784 1
0167034 03/13/2001 GA 1.08 1 .1 F 02/20/2001 The patient's mother states, on 01/31/01 this baby was very irritable, not sleeping, and a rash appeared on 02/01/01. She called the health dept and told to take her to the doctor. The mother states the baby had a seizure on 02/07/01 and was hospitalized for one day. The baby okay, but the same states the mother. The baby's right side weak states mother. The mother is to call the child's MD to inform of the child's condition. Y Y 1 Y 01/31/2001 01/31/2001 0 PUB PUB NONE NONE NONE GA01014 1
0167035 03/13/2001 CA 0.8 0 .3 F 02/27/2001 The pt experienced hysterical screaming for 24 hours post vax. Y 12/21/2000 12/21/2000 0 PVT PVT NONE NONE NONE 1
0167036 03/13/2001 IA 1.0 1 .0 M 03/02/2001 Large redness and swelling at injection site with induration 8cm X 4cm; redness 1cm X 5cm on left thigh. U 02/28/2001 03/01/2001 1 NONE PVT PVT NONE Otitis Media; delayed visual maturation 1
0167037 03/13/2001 MA 1.5 1 .6 F 03/02/2001 Pain in right leg, shaky leg, limping, fever to 102F. Symptoms are subsiding by 3/1/01. Last temperature was on 2/27/01. Y 02/26/2001 02/26/2001 0 PVT UNK 1
0167039 03/13/2001 WI 1.6 1 .6 F 02/18/2001 Increased temperature controlled with Motrin. Temperature was 104.5 (R) at one time when not given Motrin; lethargic. Y 02/07/2001 02/07/2001 0 PUB PUB Slight cold Potential asthma ~DTP (no brand name)~~0.20~In Sibling WI0114 1
0167040 03/13/2001 CA 4.0 0 .4 F 02/20/2001 Became "zombie-like", limp and decreased responsiveness. Decreased eating. Gone by the next day. Y 10/05/2000 10/05/2000 0 NONE PVT PVT NONE 1
0167041 03/13/2001 GA 0.7 0 .7 F 02/12/2001 Decreased appetite, irritability and restless sleep. Doctor treated infant for otitis media, thrush and pharyngitis on 2/13/01. Doctor advised against continuing Prevnar. Y Y 02/05/2001 02/05/2001 0 NONE PUB PUB NONE NONE NONE GA01010 1
0167042 03/13/2001 GA 1.4 1 .5 M 02/16/2001 Papular rash around injection site, noted 6 hours, post Prevnar vax, given on 2/14/01. On 2/16/00, this morning, noted to be over entire body. Y 02/14/2001 02/14/2001 0 PUB UNK NONE GA01011 1
0167043 03/13/2001 AK 1.0 1 .0 F 01/22/2001 Mother of pt states "hives" developed within 15 minutes, post vax; treated with Benadryl at 12:50. Infant observed and discharged at 13:00 from ER and sent home with Benadryl. Y Y 01/22/2001 01/22/2001 0 NONE PVT PUB NONE NONE NONE AK200109 1
0167044 03/13/2001 AK 2.0 2 .6 M 01/30/2001 Red macular rash on face, backs of hands, neck and shoulders. Note: I do not believe this is a vaccine reaction; I believe it is an exacerbation of impetigo. Y Y 01/25/2001 01/26/2001 1 NONE PUB UNK Impetigo on chin AK200111 1
0167045 03/13/2001 AK 0.8 0 .9 M 01/26/2001 High fever and a seizure; sent to doctor for work-up today. Y Y 01/23/2001 01/26/2001 3 PUB PUB NONE NONE AK200110 1
0167046 03/13/2001 AK 0.75 0 .7 M 01/19/2001 Pt had a seizure by history on 1/16/01, 7 days, post vax. There was no associated illness or fever. Y 01/09/2001 01/16/2001 7 CBC; Electrolytes; Calcium-nml on 1/17/01 PVT PUB NONE NONE NONE AK200108 1
0167047 03/13/2001 CA 0.5 0 .5 M 02/23/2001 On 2/21/01 at 08:00, injection site sore; child fussier than usual. On 2/22/01 at 05:00, mom noticed rash on legs and stomach; rash spread to back, arms, hands and face. Feet and hands were swollen. Y Y 02/20/2001 02/21/2001 1 PUB PUB NONE NONE NONE 1
0167048 03/13/2001 PA 63.0 61 M 03/04/2001 About August 1999, following the 2nd injection of Lymerix vaccine, this patient developed ache and stiffness in his right knee. He saw a doctor about it and was sent to a specialist who gave him a Cortisone shot and had x-rays taken. The Cortisone shot did not help. N 04/13/1999 08/01/1999 110 X-ray - patient was told they showed nothing. PVT OTH NONE NONE NONE Joint stiffness~Lyme (LYMErix)~~62.00~In Patient 1
0167049 03/13/2001 TX 11.0 12 M 03/16/2001 45 minutes to an hour after administration, while riding home in the car, the patient complained of a headache, became weak, and by history, lost consciousness. He recovered some what when he arrived home; remained weak, required assistance in walking, went to bed, slept for several hours. Normal upon awakening and has had no further problems. Y 11/20/2000 11/20/2000 0 NONE PUB UNK Albuterol, Naprosyn. ADHD, Speech disorder, Asthma, Erythromycin Allergy. 1
0167050 03/13/2001 NC 53.0 53 F 03/05/2001 This patient had brachial plexus neuropathy occurring without injury. Started after the flu vaccine was given. U 01/04/2001 01/05/2001 1 MIL OTH Nadalol, HCTZ. NONE Novacane. 1
0167051 03/13/2001 WI 39.0 39 F 03/06/2001 This patient had soreness at the site of injection, 12/07/00. The she began to develop muscle soreness, tightness in legs, that moved into her arms beginning 12/07/00. This continued through the end of January 2001. The patient was off of work from 01/02/01 to 01/19/01, due to severe fatigue, and weakness. The patient was never really evaluated by MD. She saw a hygienist for holistic treatment at the end of Jan 2001. Completely recovered as of 03/06/01. This report was completed only after the patient was relaying the problem to the school nurse. Y 12/06/2000 12/07/2000 1 NONE PUB PVT Metracycline, birth control. NONE Seasonal allergies. 1
0167052 03/13/2001 CA 1.0 1 .1 M 03/05/2001 This child developed a temperature of 104 on 03/04/01, and his sleep was restless. No cough, runny nose or other illness. Today, he's playful, no temp on 03/05/01 at 11:00 AM. Y 03/02/2001 03/04/2001 2 NONE PUB PUB NONE NONE NONE 1
0167053 03/13/2001 PA 18.0 18 F 03/05/2001 This patient had redness and swelling of her right arm. Y Y 02/26/2001 03/01/2001 3 PUB OTH NONE NONE 1
0167054 03/13/2001 CA 5.0 5 F 03/02/2001 This child's right deltoid was red, swollen (entire deltoid), fever of 101, onset within 24 hours. Y Y 02/28/2001 03/01/2001 1 PVT PUB NONE NONE 1
0167055 03/13/2001 AZ 11.0 11 F 03/06/2001 This child presented to school nurses office 02/27/01 at 8:30 AM with a few scattered papules on both forearms and more diffuse maculo-papular rash upper and lower legs bilaterally. Afebrile. The family physician advised Benadryl for 6 days. Rash resolved on the 7th day. Y 02/26/2001 02/26/2001 0 NONE OTH PUB NONE NONE NONE 1
0167056 03/13/2001 IA 39.0 39 M 03/09/2001 This patient received yellow fever vaccination subcutaneously to left posterior tricep area. The patient presents on 03/01 at 2:14 PM. The area was examined and he had a 2.0 x 2 1/2 cm raised indurated area. Y 03/03/2001 03/04/2001 1 MIL MIL Amoxicillin Sinus infection NONE 1
0167057 03/13/2001 WA 13.0 13 F 03/02/2001 A shot was given at school clinic by health dept RN. The patient's mother called and said she felt nauseous and had cramping in her legs and about 15-20 minutes after the shot. The patient was in PE class and running very hard when had difficulty catching her breath and vomited. Also stated she was nauseated the day before. The mother was advised to notify the family MD if any SOB. The patient went home from school at 10 AM, slept for 2 hours, had slight SOB, was going to see the MD. Y 03/02/2001 03/02/2001 0 NONE PUB PUB NONE NONE Allergic to soaps and perfumes. 1
0167059 03/13/2001 GA 1.25 1 .3 M 02/13/2001 This patient received vaccinations on 02/12/01 around 11 AM. The mother noticed redness and swelling to right leg around 8 PM. The mother used a warm salty cloth. Y Y 02/12/2001 02/12/2001 0 PUB PUB NONE NONE GA01013 1
0167061 03/13/2001 GA 0.5 0 .5 M 02/02/2001 On 02/02/2001, the infant woke this AM with right leg swollen at the site of vaccine. Red and has knot under skin. The god parent took the child to the MD. Y Y 01/31/2001 02/02/2001 2 PUB PUB NONE URI NONE GA01008 1
0167062 03/13/2001 GA 2.0 2 .7 M 02/20/2001 This child had a swollen leg. U 02/19/2001 02/22/2001 3 PVT UNK 1
0167063 03/13/2001 WI 1.25 1 .3 F 03/05/2001 This infant was given 02/12/2001. A moderate / severe case of chicken pox started 02/19/2001, Seizure #1 on 02/20/01, febrile. Seizure # 2 on 02/21/01, atypical febrile (8 min). Acyclovir started on 02/21/01. Y Y 02/12/2001 02/20/2001 8 NONE PVT PVT NONE NONE Eczema 1
0167064 03/13/2001 AK 5.0 5 F 01/04/2000 At 5:45 PM, the patient began vomiting, lethargy, difficult to arouse, pallor, shallow breathing. He was seen in the ER, no treatment was given, improvement noted by 9:00 PM. Y Y 12/28/2000 12/28/2000 0 PVT PUB Zyrtec, Intal, Albuterol, Hydroxizine, Prednisoloe. Allergic to eggs, peanuts, strawberries, and latex. AK200106 1
0167065 03/13/2001 AK 0.25 0 .3 F 01/17/2001 Within 1 1/2 hours following vax, the pt developed a rash, wheezing, irritability. Was treated with Benadryl. The rash resolved within 1-2 days. Y Y 10/21/2000 10/21/2000 0 PVT PUB NONE NONE allergy~DTaP + Hib (no brand name)~1~0.20~In Patient AK200107 1
0167066 03/13/2001 AK 0.2 0 .2 F 01/17/2001 Report obtained from telephone conversation, from doctor that pt was referred to after 2nd adverse event on 9/18/00. Within 2 hours of vax, pt had a generalized fine rash, swelling hands and feet, followed by wheezing. Pt was given Benadryl and symptoms resolved within 2 days. Y Y 09/18/2000 09/18/2000 0 PVT PUB UNK NONE NONE AK200113 1
0167067 03/13/2001 AK 1.0 1 .1 M 02/22/2001 Pt with outbreak of about 30 lesions on back only. Suspicious for chickenpox. U 02/16/2001 02/22/2001 6 PUB PUB NONE RAD AK200112 1
0167068 03/13/2001 VA 2.0 1 .0 M 03/07/2001 Varicella rash appeared on child the 3rd day prior to office visit on 3/7/01. Received vaccine on 6/2/99. U 06/02/1999 03/04/2001 641 NONE PVT PVT NONE 1
0167069 03/13/2001 AL 55.0 55 F 08/01/2000 The 4th day, post vax, pt began with chills and high fever. By bedtime fever was 101F-102F. Chills and fever lasted 3 days. It was 100.2F on 3rd day. Had tight chest and cough that led to chronic (2 week) upper respiratory symptoms; loose cough, thick expectorant (yellow to white). Y 07/13/2000 07/17/2000 4 PVT UNK NONE NONE 1
0167070 03/13/2001 NC 51.0 51 F 03/05/2001 Localized reaction to TD. Redness measured 15cm X 11cm. Y 02/27/2001 02/28/2001 1 OTH OTH Vitamin E and Iron Dermatitis on legs Dermatitis 1
0167071 03/13/2001 NY 15.0 15 F 03/02/2001 Histamine-medicated allergic response with periorbital edema, increased lacrimation, pharyngitis and itchiness. Treated with Benadryl, epinephrine and prednisone. Y Y 02/27/2001 02/27/2001 0 NONE PUB UNK PPD/Aventis/C0256AA/ID/LA NONE NONE 1
0167072 03/13/2001 GA 1.08 1 .0 M 02/02/2001 Rash, fussy, URI and red lesions all over body. Y U 01/09/2001 02/01/2001 23 PUB PUB NONE NONE GA01007 1
0167073 03/13/2001 GA 2.0 2 .1 M 02/27/2001 On 1/18/01, call from mom stating site on left arm was swollen with red area. No drainage and no streaking. Temperature was 100.2F and resolved with Tylenol. Advised to continue Tylenol. May try ibuprofen if approved PCP. On 1/19/01, call from mom that took child to ER last night with left arm swollen and bruised from IZ, per ER. Treated with warm compresses and Tylenol. On 2/2/01, per cousin, symptoms resolved in 3-4 days. Y Y 01/17/2001 01/18/2001 1 PUB UNK NONE GA01015 1
0167074 03/13/2001 NC 59.0 59 F 12/20/1999 The pt experienced a swollen right deltoid that was hard, red in color and warm to the touch. The pt complained of pain with touch and movement. No treatment to date. Symptoms began on 12/19/99. The vaccine was a PPD. No other vaccine was listed. Y 12/13/1999 12/19/1999 6 PPD PUB PUB PPD by Connaught, lot #251711 NONE NC99105 1
0167077 03/14/2001 MI 83.0 83 F 01/12/2001 On 1/12/01, telephone call received from daughter of client who relayed that her mom was transported to health dept for a flu shot on 1/2/01 by personnel from adult care facility at 13:00. When client awoke in the AM of 1/3/01, she was unable to walk, write, had swallowing difficulties and slurred speech. She was taken by the facility's staff to ER at 16:00 on 1/3/01. She was admitted to the hospital where testing was done but daughter unsure of specific tests. Daughter stated physicians said it wasn't a stroke. She is slowly recovering. Y 7 Y 01/02/2001 01/03/2001 1 PUB PUB Diovan, Pepcid AC, Lanoxin, Amoril, Coumadin KCL, Lasix, Nitro-Dur, ibuprofen, Patch Mg oxide History of 2 strokes (1996 and 3/1998); DM; 2 endarterectomies (1997 & 12/99); quadruple bypass surgery 8 or 9 years ago. Allergies to bee stings, PCN, Percodan, Percocet; adhesive tape, Macrodantin, iodine/Betadine. Exhaustion and movements reduced~Influenza (Seasonal) (no brand name)~1~82.00~In Patient MI2001017 1
0167078 03/14/2001 ID 45.0 45 F This patient had Guillain Barre' Syndrome, vent required. Y Y Y Y U 01/03/2001 01/12/2001 9 PUB UNK Allergies to Lortab. History of asthma. ID01008 1
0167079 03/14/2001 NJ 1.0 1 .0 M 03/07/2001 Information has been received from a health professional concerning a 12 month old male who on 2/14/01 was vaccinated with varicella virus vaccine live. On 2/25/01, the pt developed a fever, irritability, varicella-like rash of 25-50 spots, "purplish flat lesions (resembling petechiae) on his face". On 2/26/01, the child was seen by the physician and was admitted to the hospital because of the purplish face lesions and the concern about possible sepsis. Sepsis and bacteremia were ruled out during the hospitalization. The pt's hospital course was uncomplicated and he was discharged. The discharge dx was probably "allergy to (varicella virus vaccine live). "The child is being treated at home with Benadryl every 6 hours. He was seen in the physician's office on 3/1/01 and all signs and symptoms had resolved with the exception of the facial lesions. The facial lesions were improving, but were not completely resolved. Additional information has been requested. Follow up on 06/29/2001: "Lot # for vaccine 1 is not provided." Y N 02/14/2001 02/25/2001 11 OTH OTH Amoxicillin, Rondec Bronchitis WAES01030023 1
0167114 03/14/2001 NH 4.0 4 F 03/12/2001 Red, tender area below injection site 4" oval, extending to injection site. Still red on 3/12/01. Treated with Benadryl, Tylenol and ice. Y U 03/08/2001 03/10/2001 2 NONE PVT PUB NONE NONE NONE NH0108 1
0167115 03/14/2001 MN 1.75 1 .3 F 02/22/2001 Rash, itching and weeping on hands, face, arms and legs. Had a runny nose and a cough. Per doctor's visit on 4/13/98; typical varicella. Treated with Benadryl elixir prn for itching. Y 10/28/1997 04/13/1998 167 NONE PVT PVT On antibiotic since 4/10/98. 1
0167116 03/14/2001 MN 3.0 3 M 02/22/2001 On 9/8/98, complained of rash, "blisters all over", on scalp, arms. Has pruritic papular lesions, which started on back and some on hand, arms and neck. Differential dx: insect bite. Hyperactive, no able to sit still at all. Chickenpox, probable post vax. Treat with Benadryl, Domeboro and Lotrimin. Y 08/18/1998 09/08/1998 21 PUB PUB Bactroban Impetigo NONE 1
0167117 03/14/2001 MN 1.01 1 .0 M Exposed to chickenpox multiple times before getting vaccine. Broke out in rash, 1 week, post injections. Mother stated he was covered. Y 04/07/2000 04/14/2000 7 NONE PUB PUB NONE NONE 1
0167118 03/14/2001 MN 3.0 3 F 02/22/2001 Seen by doctor in another city; had red, fine rash on trunk of body, lasting 4 days. Y 01/25/2001 01/26/2001 1 NONE PUB PUB Cerebral Palsy; Reactive airway; Prematurity at 26 weeks; Retinal detachment; Seizures; Allergies to Amoxicillin, Erythromycin, Tegretol 1
0167119 03/14/2001 MN 4.0 1 .1 F 02/28/2001 Child is ill with sore throat, cough and noticed some red spots this AM. Had varicella shot on 2/28/97. On exam: throat red, tonsils +1 without exudate. Onset last night, of raised papular/pustules on erythematous base on chest; several more appeared, then spread to face. Has about 6-8 lesions on chest and 6 on face and is itchy. Also had exposure to chickenpox in daycare. Dx: chickenpox and URI. Treated with Benadryl elixir for itching; lukewarm baking soda baths; keep away from other children over the weekend to observe how rash progresses. RTC if worse. Y 02/28/1997 03/03/2000 1099 NONE PVT PVT 1
0167120 03/14/2001 ID 31.0 31 F Left hand and arm had localized edema, left arm became cold, elbow joint hurt and couldn't lift arm. Arthralgia in left elbow. Became dehydrated and very tired. Pt took Tylenol and rested. Swelling and pain decreased within 48 hours. Y Y 01/24/2001 01/24/2001 0 NONE OTH UNK NONE NONE Currently being tested for allergies ID01007 1
0167121 03/14/2001 ID 33.0 33 F 02/08/2001 Had a hard lump, 30 minutes, post vax. It was warm at bedtime and felt a little itchy. Had blood on arm the size of a 50 cent piece and site was king of blue. On 2/7/01 AM, still had bruise (blue). At noon it started severe itching and area got redder and hard spot grew to 1" to 1 1/2" in diameter. By the evening, area was 6" to 8" long and 3" wide (red, hard and hot). She used cool compresses and ibuprofen. The next AM, she went to MD and was prescribed Augmentin. Y U 02/06/2001 02/07/2001 1 NONE PUB PUB NONE NONE Seasonal allergies ID01009 1
0167122 03/14/2001 HI 4.0 4 F 02/22/2001 Complains of soreness at site of DTAP. 7cm area of induration and redness; no fluctuance; limp secondary to sore muscle about 1 day after DTAP shot. Treated with warm compress. Local reaction only. U 02/20/2001 02/21/2001 1 PVT PUB PPD/LFA/Sc; Amoxicillin Sinusitis NONE HI0101 1
0167123 03/14/2001 NC 1.25 1 .3 M 02/14/2001 Post vax, left thigh became swollen and red. Parents treated at home with acetaminophen and ibuprofen. Arrived at ER at 21:00. ER nurse documented leg swollen from hip to knee, warm to touch and red. Pt able to walk with limp. Dx'd with allergic reaction and given Benadryl and sent home. Did not return to ER. Y U 12/06/2000 12/06/2000 0 NONE PVT PUB Acetaminophen at 16:30 and ibuprofen at 19:30 NONE Tubes in ears in 2000 NC01029 1
0167124 03/14/2001 NC 0.2 0 .2 M 03/01/2001 5 minutes, post vax, mother was putting child in car seat when she noted infant to be limp and pale. She returned immediately to examining room. Infant was sleepy but arousable, which improved slowly over 30 minutes. Vital signs stable. No localized reaction. Y 02/01/2001 02/01/2001 0 NONE PVT PVT NONE NONE NONE NC01025 1
0167125 03/14/2001 MN 1.5 1 .5 F 03/06/2001 Pt complaining of sore throat and "bottom" itches and says it hurts to urinate. On exam, throat is red with anterior nodes. Was exposed to strept. Treated with Amoxicillin. Return if not better in 2 or 3 days. Y 01/19/1998 03/07/2000 778 UA-neg UNK UNK 1
0167126 03/14/2001 NY 13.0 13 F 03/05/2001 13 year old female with developing skin rash on face, arms and legs, post vax. Pt was treated with Atarax 25mg and calamine lotion. Y N 03/01/2001 03/02/2001 1 NONE PUB PUB NONE NONE NONE 1
0167127 03/14/2001 UT 0.3 M Per mother's report, son had about 6 hours of inconsolable crying, starting a few hours, post vax, at his 4 month well child check. He was not examined at the time of his reaction. He fully recovered by the next morning. Y 12/07/2000 12/07/2000 0 UNK UNK 1
0167128 03/14/2001 NC 1.5 1 .5 F 03/02/2001 Pt given vaccines at 11:15 and 5 minutes later, pt broke out with hives on both feet. Treated with 1 tsp Benadryl at 11:30. Y 03/02/2001 03/02/2001 0 MIL PUB NONE NONE URI, Murmur, RSV, Pneumonia 1
0167129 03/14/2001 NJ 36.0 36 M 03/05/2001 Started feeling ill on 2/28/01 with sore throat and complained of painful and difficulty swallowing. Complained of swelling of throat to ear. Y Y 02/27/2001 02/28/2001 1 OTH OTH NONE Allergy to food (fresh fruit) 1
0167130 03/14/2001 VA 26.0 26 F 02/26/2001 Erythema and induration, 4cm diameter, at injection site, 30 hours, post vax. U 02/23/2001 02/24/2001 1 PVT PVT hydrocortisone 1% cream, Claritin, Reditab Insect bite with infection Endometriosis, Allergy to sulfa 1
0167131 03/14/2001 CA 71.0 70 F 03/06/2001 In area of deltoid and upper bicep, pt developed induration, erythema and vesicular rash, resembling poison oak dermatitis but non-pruritic. U 03/03/2001 03/04/2001 1 PVT PVT NONE Myelodysplasia, Colon CA 1
0167132 03/14/2001 CA 1.2 1 .2 M On 2/13/01, noted thigh was red, swollen and warm. Seen on 2/14/01 and treated with ibuprofen and Keflex. Y Y 02/12/2001 02/13/2001 1 NONE PUB PUB 1
0167133 03/14/2001 CA 1.25 1 .3 F 02/23/2001 Swelling and redness at the site and covering upper arm X 3 days, post vax. Then developed a fever to 102.3F and cough, runny nose and bilateral otitis media. Dx'd on 2/23/01 with questionable immunization reaction. U 02/15/2001 02/16/2001 1 NONE OTH PUB NONE Viral URI NONE CA010016 1
0167134 03/14/2001 CA 69.0 69 F 11/22/2000 Pt noted right upper arm with redness, warmth, pain and swelling on the same night as vaccines were given. Y 11/21/2000 11/21/2000 0 PUB PUB NONE Arthritis Allergy to PCN CA000165 1
0167135 03/14/2001 KS 0.25 0 .2 M 03/08/2001 After shots on 1/9/01, unusually intense crying for less than 3 hours. Fever, acted as though not well, for the next 3 days. Frequent bouts of crying, increase in spitting up and projectile vomiting, small amounts of bloody mucus in stool. Did not sleep for more than 1 hour at a time. On 1/13/01, had rapid breathing during nap, stopped breathing. I picked him up and patted his back, he took a few breaths and then stopped, went limp, eyes rolled back and his head rolled. Regained consciousness in 10 seconds. That night he slept for 8 hours and the next night he slept for 9 hours. He seemed his normal self again about 2 weeks, post vax. Y 01/07/2001 01/13/2001 6 PVT PVT Colic attributed to milk allergy 1
0167136 03/14/2001 AZ F 03/07/2001 Screaming reaction, post vax with pertussis, which lasted approx. 6-8 hours. Y 02/26/2001 02/26/2001 0 PVT PVT UTI (12/29/00) Bronchiolitis; GERD 1
0167138 03/14/2001 MI 47.0 47 M 02/21/2001 Pt called HD on 2/21/01 to report that the site of shot in left deltoid and shoulder and up into neck was red, warm, swollen and very painful to move arm. Referred to Dr on 2/21/01. Y U 02/05/2001 UNK PUB PVT Anti-inflammatory; Vioxx NONE Allergy to codeine and a history of arthritis. MI2001018 1
0167139 03/14/2001 IL 1.5 1 .5 F 03/09/2001 Mom reports fever of 103F for 24 hours. Mom reports pain at site of injection. Tylenol was given around the clock with no help noted. Y 03/08/2001 03/08/2001 0 PUB PUB NONE NONE NONE 1
0167140 03/14/2001 AR 13.0 13 M 03/01/2001 Mother relates; after being back in class about 45 minutes, child complained of nausea and dizziness, left classroom to go the office and "blacked out after becoming extremely dizzy and paling. He remembered then getting to a table to lie down. Parents carried child to doctor at clinic who related that he probably had an adverse allergic reaction to the TD. He was treated with Benadryl there and referred to a neurologist. Y Y 03/01/2001 03/01/2001 0 UNK PUB UNK NONE NONE NONE AR0114 1
0167141 03/14/2001 NY 1.4 1 .4 M 03/08/2001 Redness at injection site on right deltoid that spread up over shoulder and down to mid-upper right arm. Also had swelling and a fever of 102F. Y 03/05/2001 03/06/2001 1 PVT PVT NONE NONE NONE 1
0167142 03/14/2001 IN 11.0 11 M 03/09/2001 Pt complained of severe headache the day after vaccinations. Headache lasted 24 hours and then improved. Y 03/07/2001 03/08/2001 1 PUB PUB NONE 1
0167143 03/14/2001 OH 0.3 0 .4 M 02/15/2001 On 9/28/00, vaccine given and in the evening, child was sleepy. On 9/29/00, child started shaking his head and became limp and sleepy and had a slight fever. On 9/30/00, child was taken to ER. On 10/01/00, child was taken to doctor who told the parents it could be related to DTAP. Y 09/28/2000 09/29/2000 1 PUB PUB OH0007 1
0167144 03/14/2001 OH 12.0 12 F 02/12/2001 Pt came to clinic for vaccinations. She stated she had rash and itching several hours, post vax, given on 1/11/01. States rash was generalized small bumps and lasted for several hours. Rash and itching gone in several hours. Y 01/11/2001 01/11/2001 0 PUB PUB UNK UNK UNK OH0006 1
0167145 03/14/2001 OR 58.0 58 F 02/12/2001 Returned to clinic on 2/7/01 with redness and swelling in upper left arm. Also had swollen upper lip that AM but this resolved. Y 02/05/2001 02/07/2001 2 NONE OTH OTH Asthma, Perennial allergies OR200105 1
0167146 03/14/2001 OR 5.0 5 F 02/15/2001 Incontinent X 2 the night of vaccine (unusual). On 2/13/01, had sore throat and night sweats but no fever. On 2/14/01, talked in sleep, restless, sweaty and headache. On 2/15/01, pallor and decreased appetite. No pain. U 02/09/2001 02/10/2001 1 NONE PUB PUB NONE NONE NONE OR200104 1
0167147 03/14/2001 OR 14.0 14 M 02/14/2001 Low-grade temperature, nauseated and fatigued. This also happened with the last IZ, however, states the symptoms were worse this time. Y 02/12/2001 02/12/2001 0 NONE PUB PUB NONE OR200103 1
0167148 03/14/2001 MI 3.0 3 F 02/12/2001 Post vax, child tolerated well with crying. At about 13:10, child taken from lying on the floor horizontally to table, pale. Child was picked up, placed sitting on table and began crying. Child's little brother (infant) was receiving vaccines at the time. The doctor was called to child's side. Vital signs: pulse-102; resp-30; BP-92/50; pulse ox-96-97. Child occasionally crying "I want to go home". Y 02/06/2001 02/06/2001 0 PVT PVT NONE 1
0167149 03/14/2001 NJ 32.0 32 F 03/02/2001 She claimed that 24 hours, post vax, she developed chills, body malaise, nausea, redness and tenderness at injection site. She was bed-ridden on the following day and noted swelling and increased pain at injection site. All symptoms resolved on 2/12/01, 5 days, post vax. Y 02/07/2001 02/08/2001 1 NONE PUB PUB NONE NONE 1
0167150 03/14/2001 VA 29.0 29 F 03/08/2001 Pt received second JEV around 09:00 on 2/16/01 and later on that morning, she developed a headache and nausea. Approx. 8 hours later, she noticed swollen feet, eyes, hands and whole body. 3rd dose not given secondary to above reaction. Y 02/16/2001 02/16/2001 0 MIL MIL NONE NONE 1
0167151 03/14/2001 FL 39.0 39 F 03/03/2001 No chills or fever. Face and arms red and itchy with pinpoint, flat, pink spots confluent over cheeks and forehead; less dense over neck and chest and a few on arms; none on back and abdomen. Mild sore throat and conjunctiva mildly injected. Mild arthralgia in knees and fingers. Rx'd Zyrtec, ibuprofen. Improved in 2 days. Y 12/25/2000 01/08/2001 14 11/16/00-Rubella IgG 0.7; 1/12/01-Rubella IgG-2.37; 1/30/01-Rubella IgG-80.7. Reference Rubella IgG >1.10=POS; Rubella IgG>15=reactive PVT PVT Synthroid NONE Hypothyroidism 1
0167152 03/14/2001 AL 64.0 64 F 03/06/2001 Pt states that area at TD site (LA) was swollen, red, deep pain and "swelling at night". All symptoms starting "next day". Took Tylenol approx. 8 hours, post vax. Started compresses (heat) "next day". Y 02/27/2001 02/27/2001 0 PUB PUB Premarin; K+; ASA; Cartiaxt; HTCZ; Vit C & E. NONE 1
0167153 03/14/2001 TX 1.08 1 .0 M 03/02/2001 Mother called our clinic to report rash (chickenpox in nature). Pt not ill appearing. Treat with calamine lotion. Y 02/06/2001 02/27/2001 21 OTH PUB NONE Right hydrocele (resolving) 1
0167154 03/14/2001 GA 24.0 24 F 02/22/2001 Post vax, that night, she had a slight rash on neck, face and bodice that itched. She took Benadryl and it went away. Two weeks later, the rash reappeared from elbow to knees. Today from ears to toes. Also had itching. No other symptoms. Taking Zyrtec and is still itching but is a lot better. Possible delayed reaction to Rabies vaccine. Y 02/08/2001 02/09/2001 1 PUB PUB NONE NONE NONE 1
0167155 03/14/2001 CA 0.2 0 .3 M 03/06/2001 Within < 1 minute, post vax, pt had total body flushing without other symptoms. Rx'd Benadryl po and resolved. Y 11/15/2000 11/15/2000 0 Immediate-type skin tests to all 4 vaccines (prick F.S. & ID 1:100) (-) MIL MIL 1
0167180 03/14/2001 OK 4.0 4 F 03/12/2001 Pt received the Prevnar injection on 3/6/01. This is the only IZ she received. Tuesday night her left arm was bright red 3" X 2", warm to touch, hard and sore. After applying moist heat her arm began to look better on Saturday the 10th and on Monday the 12th, her arm just looked bruised. Y 03/06/2001 03/06/2001 0 OTH OTH NONE NONE NONE 1
0167182 03/14/2001 MI 2.0 2 .5 M 02/28/2001 On 2/22/01, pt's mom called and informed us that he had a red blotchy rash 2-3" around the injection site. Mom gave him Benadryl. That evening he had a prickly rash on both legs and on his back which came around to his sides; he also had large red circles on both cheeks and a fever of 99.1F. Y 02/20/2001 02/22/2001 2 PUB PUB Chromalin daily respiratory treatment NONE MI2001019 1
0167183 03/14/2001 GA 0.7 0 .7 F 03/07/2001 Mom called to report that she took pt to ER the day after receiving injections because of persisting fever and irritability. No swelling, no redness at sites. Today child is still irritable but not febrile. Advised to give Motrin and bring child to clinic if still irritable. Y Y 02/25/2001 02/27/2001 2 PUB PUB NONE NONE NONE 1
0167184 03/14/2001 GA 1.75 1 .8 F 03/01/2001 Mom called to say child favoring right leg and had swelling and redness at site of injections given yesterday. No fever. Hard lump on right leg remained as of 3/7/01. No warmth or redness or fever. No more lump. Y 02/28/2001 03/01/2001 1 PUB PUB NONE NONE Mild hydronephrosis 1
0167185 03/14/2001 AL 1.6 1 .5 M 03/02/2001 Fever of 102F, night after vaccination, with erythema and swelling of right thigh with vesicles. U 02/28/2001 02/28/2001 0 PVT PUB NONE NONE NONE AL0103 1
0167186 03/14/2001 MO 2.0 2 .3 M 03/07/2001 Immunization given on 3/2/01. Presented to ER on 3/4/01 with complaint of red, swollen and painful right upper arm. Dx'd with right arm cellulitis. Treated with Benadryl and Keflex. Mother follow-up in physician's office on 3/5/01. No further orders. Y Y 03/02/2001 03/04/2001 2 NONE PVT PUB NONE NONE NONE 1
0167187 03/14/2001 SC 0.6 0 .6 F 03/05/2001 High-pitched cry X 2 days, post vax. Y 03/01/2001 03/01/2001 0 NONE OTH PUB Robitussin DM Mild URI NONE 1
0167188 03/14/2001 CA 1.25 1 .3 F 02/23/2001 Right upper thigh with 3" X 2 1/2" erythematous area; fever to 102.8F X 2 days and vomiting. Y Y 02/20/2001 02/21/2001 1 PVT PVT NONE 1
0167189 03/14/2001 GA 0.5 0 .5 F 03/05/2001 Serum sickness reaction occurred within 24-48 hours, post vax. Had a fever up to 39.4F, vomiting, swelling of hands, feet and knees with erythema of overlying; skin (maculo-papular) rash on dorsum of feet. Treated with Solu-Medrol IM, Prelone and Atarax. Y Y 02/28/2001 03/01/2001 1 UA-Trace proteinuria PUB PUB triamcinolone cream, Atarax liquid Atopic dermatitis Atopic, seborrheic dermatitis 1
0167190 03/14/2001 TX 0.3 0 .2 F 02/16/2001 Post vax, mom took infant home for a nap and when she got up, the right side of her tongue was swollen and the left side of her cheek was swollen. Infant made noises (baby talk) like she had a thick tongue. No breathing problems. Within 30 minutes, the symptoms disappeared. No medical evaluation was needed and no medicines. No problems breathing. Y 10/20/2000 10/20/2000 0 PUB PUB Obstructed left lacrimal duct 1
0167191 03/14/2001 CO 1.5 1 .5 F 03/09/2001 Staring spell, drooling, collapse, neck stiffness which lasted 15 to 20 minutes before full recovery, but still stuttering. Y N 03/07/2001 03/07/2001 0 CBC with diff; Blood culture; UA and Urine culture-pending PVT PVT UrI-viral Allergic rhinitis 1
0167212 03/14/2001 VA 49.0 48 M 03/06/2001 Left arm stiff and achy, within a few hours, post vax, especially left elbow, and after 2nd dose had extreme stiffness and aching in both knees X 4 days. Still have symptoms in knees and elbows. N 02/03/2000 02/03/2000 0 PUB PUB NONE 1
0167213 03/14/2001 VA 53.0 52 F 02/21/2001 Site tenderness over right arm, immediately, post vax. Joint swelling and tenderness, within a couple of days, post vax. Pain in right elbow, soreness at right elbow, right hip and entire right leg and also pain at right knee and foot. Still have symptoms and are ongoing problems. N 02/03/2000 02/05/2000 2 Was told by MD, approx. 2 years ago, that I did not have Rheumatoid Arthritis. PUB PUB Cardiac problems 1
0167214 03/14/2001 VA 50.0 49 M 02/21/2001 Shoulder soreness and flu-like symptoms within 24 hours, post vax. Has had residual pain of right hip, thigh down to ankle since vaccine was given. This causes a limp with walking. Pain continues daily; ongoing problems. Is followed closely by a physician every 3 months. N 02/03/2000 02/04/2000 1 PUB PUB Diabetes 1
0167260 03/14/2001 CA U 09/03/1999 It was reported that a pt (3 of 3) experienced a local reaction sometime after receiving a combination vaccine of Tripedia and ActHIB given as TriHIBit. No specifics were provided. U UNK UNK U1999006300 1
0167261 03/14/2001 IL 0.9 0 1 M 06/28/2001 "A nurse reported that an 11 month old male received Rota Shield and Tripedia on 5/11/99 and subsequently developed a poor appetite. He was seen by the physician. The infant's appetite returned within 10 days. This is 1 of 2 pts from this facility who had an adverse experience following receipt of Rota Shield. The infant received a 2nd dose of Rota Shield on 6/15/99 without any adverse reaction. From additional information received on 9/29/99, additional pt information was provided. From mailed follow-up correspondence received on 06/13/01, it was reported that the patient recovered from this experience. No further information is anticipated for this report. Case is closed Y Y 05/11/1999 UNK PVT PVT Zantac NONE NKA U199900637 1
0167265 03/14/2001 TX 0.2 0 .2 F 09/23/1999 It was reported, that a female pt received vaccines on 8/3/99. Reportedly, 4 hours, post vax, the pt experienced swelling of left thigh from knee to thigh, redness and tenderness to touch. Reportedly, the pt was seen in the ER. From additional information received on 8/19/99, additional pt and doctor information was provided. Y U 08/03/1999 08/03/1999 0 PVT PVT U1999005520 1
0167266 03/14/2001 TX 0.2 0 .2 F 09/23/1999 It was reported, that a female pt received vaccines on 8/4/99. Reportedly, 4 hours, post vax, the pt experienced swelling of her left thigh from knee to thigh, redness and tenderness to touch. From additional information received on 8/19/99, additional pt and doctor information was provided. U 08/04/1999 08/04/1999 0 PVT PVT U1999005530 1
0167267 03/14/2001 OH 0.5 0 .5 M 09/23/1999 It was reported, that a 6 month old pt received a Tripedia vaccination on 8/2/99. Reportedly, on 8/4/99, the pt developed a large local reaction and a low-grade fever. From additional information received on 8/19/99, additional pt and doctor information was provided. U 08/02/1999 08/04/1999 2 PVT PVT U1999005560 1
0167268 03/14/2001 CA U 08/09/1999 It was reported that sometime after receiving a Tripedia vaccination a pt experienced redness the size of a quarter with a lump at the injection site, which was also very hot. No specified details were provided, follow-up is in progress. U UNK UNK U1999005580 1
0167269 03/14/2001 NJ 1.75 1 .8 M 11/12/1999 It was reported that a 21 month old male received vaccines on 8/12/99. Reportedly, that same night, the pt experienced cough, during the night, swelling of his left arm and possible slight fever. Pt was given Tylenol, then Motrin and suggestion of cool compress was made. Swelling was from the injection site with hardness almost down to elbow. Questionable difficulty with breathing during the night. No asthma meds given. Swelling resolved by 8/16/99. From additional information received on 11/8/99, it was reported, "Reviewed, no additional information at this time; 11/1/99". An amendment in the pt's last name was made. Y 08/12/1999 08/13/1999 1 PUB PUB NONE Asthma U1999006030 1
0167270 03/14/2001 NJ 2.0 2 .1 M 11/12/1999 It was reported that a 2 year old male received a DTaP-Tripedia vaccination on 8/10/99. Reportedly the patient awakened the next morning with left arm red, swollen, hot and hard at injection site and almost down to elbow. No increased temperature and no apparent discomfort. Normal activities and diet. Used cool compresses, Tylenol times 1 or 2. Swelling resolved as of 8/14/99. From additional information received on 11/8/99, it was reported, reviewed, additional information box #18. Follow up #1 (8/12/02): During internal review of all files, it was deemed necessary to amend the report by updating the adverse event coding (deleted fever) and (changed edema to injection site swelling). Y 08/10/1999 08/11/1999 1 PUB PUB Possible allergies to grass, trees and mold. U199900604 1
0167272 03/14/2001 CA U 09/03/1999 It was reported that a pt experienced a local reaction sometime after receiving combination vaccine of Tripedia and ActHIB given as TriHIBit. U UNK UNK U199900628 1
0167273 03/14/2001 CA U 09/03/1999 It was reported that a pt (2 of 3) experienced a local reaction sometime post vaccine. U UNK UNK U199900629 1
0167274 03/14/2001 WA 0.3 F 09/10/1999 Mother stated pt developed upper and lower body shakes. Low grade fever. Y U 08/18/1999 UNK UNK U1999900649 1
0167275 03/14/2001 NJ 0.5 0 .5 M 10/05/1999 Two days post vax, the pt developed explosive diarrhea, 2 episodes of vomiting, crankiness and colic. The pt was seen by a physician and subsequently recovered. Y Y 07/14/1999 07/16/1999 2 UNK PVT PVT NONE UNK U1999006550 1
0167276 03/14/2001 SC 2.0 1 .3 M 10/20/1999 It was reported that a male patient received a fourth dose of DTaP-Tripedia, first dose of OPV and MMR and the fourth dose of ActHIB vaccines on 12/30/97. Reportedly, on 9/11/99, a nasopharyngeal swab culture was done which was positive for Bordetella Pertussis. Nasopharyngeal swab culture was negative. Nasopharyngeal swab stain was posiitive. Follow up #1 (6/26/02): During internal review of all files, it was deemed necessary to amend the report by updating the adverse event coding (pharyngeal swab culture positive for Bordetella pertussis). U 12/30/1997 09/11/1999 620 Nasopharyngeal swab-positive for Bordetella Pertussis UNK UNK U1999007410 1
0167277 03/14/2001 SC 2.0 1 .2 M 10/20/1999 It was reported that a male pt received vaccines on 12/11/97. Reportedly, on 9/11/99, a nasopharyngeal swab culture was done and was positive for Bordetella Pertussis. U 12/11/1997 09/11/1999 639 Nasopharyngeal swab culture-positive for Bordetella Pertussis UNK UNK U1999007420 1
0167278 03/14/2001 NY 1.25 1 .3 M 07/13/2001 It was reported that a 16 month old male received vaccines on 10/20/99. Reportedly, that same day, the pt experienced a large local reaction of redness, erythema and swelling. From additional information received on 11/8/99, it was reported that the pt experienced this adverse reaction on 10/22/99, rather than 10/20/99, as previously reported. The pt also experienced limited range of motion and was afebrile. The pt reportedly recovered from this experience. Additional information received on 11/30/99, stated the vaccination occurred at a private doctor's office with private funds. The pt also had 2 previous IPV doses. From mailed follow-up correspondence received on 07/05/01, it was reported that the patient did not receive OPV vaccineation on 10/20/99 as previously reported.the last OPV vaccinations given was on 06/21/99. This case is closed. Y 10/20/1999 10/22/1999 2 NONE PVT PVT Amovil (Rhinitis) NONE NKA U199900821 1
0167281 03/14/2001 PA 1.5 1 .5 M 12/15/1999 It was reported that an 18 month old male received vaccines on 10/18/99. On the same day, the pt's "left arm (was) red, hard, warm and swollen." This lasted for 2 days. The pt has recovered. Correspondence received stated, on 11/22/99, "Reviewed, no additional info." Y 10/18/1999 10/18/1999 0 PVT PVT Vitamins with fluoride Cough and congestion, improving U1999008680 1
0167282 03/14/2001 PA 1.5 1 .5 F 07/24/2001 It was reported that an 18 month old female received vaccines on 10/20/99. On 10/21/99, the pt's "left upper arm (was) red, hot (and) swollen". The pt has recovered. Correspondence was returned on 11/22/99 as, "Reviewed, no additional info." From mailed follow-up correspondence received on 07/23/01, it was reported that the patient recovered from this experience. No further available regarding this patient or this case. This case is closed. Y 10/20/1999 10/21/1999 1 PVT PVT U199900869 1
0167283 03/14/2001 PA 1.5 1 .5 F 07/24/2001 It was reported that an 18 month old female received vaccines on 10/18/99. Then the pt's "arm (was) warm and swollen". This lasted for 2 days. The pt has recovered. Correspondence was returned on 11/22/99, as having been reviewed with no additional information. From mailed correspondence received on 07/23/01, it was reported that the patient recovered from this experience. No further information available regarding this patient or this case" This case is closed. Y 10/18/1999 PVT PVT U199900870 1
0167285 03/14/2001 TN 0.5 0 .6 F 11/08/1999 It was reported that an infant pt received vaccines on 11/3/99. Reportedly, within minutes, post vax, the pt's entire leg and buttocks became reddened. The pt also developed red blotches on chest and back; no respiratory distress. U 11/03/1999 11/03/1999 0 UNK UNK U1999008750 1
0167286 03/14/2001 PA 1.5 1 .5 M 12/13/1999 It was reported that an 18 month old male received vaccines on 11/2/99. On 11/3/99, he experienced "localized erythema, mild induration at injection site 6cm X 8cm". The pt has recovered. On 11/17/99, the document was reviewed and there was no additional information at this time. Y 11/02/1999 11/03/1999 1 PVT PVT PVF Mild URI Craniosynostasis, BIH-repaired U1999009240 1
0167287 03/14/2001 PA 1.0 1 .1 F 11/10/1999 It was reported that a female received vaccines on 11/1/99. On 11/2/99, she experienced "localized erythema and swelling of the left thigh 8cm X 6cm and mild warmth to the area". The pt has recovered. Y 11/01/1999 11/02/1999 1 NONE PVT PVT Luride NONE Alfa thalassemia trait U1999009250 1
0167288 03/14/2001 PA 2.0 2 .3 M 12/14/1999 It was reported that a 26 month old male received vaccines on 11/1/99. On 11/2/99, he experienced "localized erythema and mild induration at injection site of 5cm X 6cm". The pt has recovered. On 11/17/99, document reviewed, no additional information at this time. Y 11/01/1999 11/02/1999 1 PVT PVT Luride NONE NONE U1999009260 1
0167289 03/14/2001 PA 1.5 1 .5 F 12/15/1999 It was reported that an 18 month old female received vaccine on 11/2/99. Reportedly, on 11/3/99, between 07:00 and 08:00, the pt developed localized erythema and mild induration at injection site with bruising 7 1/2cm X 9cm, mild swelling and was warm to touch. Reportedly, this adverse reaction is presently resolving. Documentation received on 12/1/99, added that there were no labs performed and that the pt had recovered, at this time. Y 11/02/1999 11/03/1999 1 NONE PVT PVT NONE NONE U1999009430 1
0167290 03/14/2001 PA 4.0 4 M 12/28/1999 It was reported that a 4 year old male pt received vaccines on 11/8/99. 36 to 48 hours, post vax, the pt developed local erythema and tenderness. From additional information received on 12/14/99, it was reported, "Reviewed, no additional information at this time." U 11/08/1999 11/10/1999 2 PVT PVT NONE NONE U1999009440 1
0167291 03/14/2001 TX 1.25 1 .3 M 01/20/2000 It was reported that a 15 month old male received vaccines on 11/11/99 at 11:00. Reportedly, at 11:30, the pt's ears and eyes began to swell, developed generalized hives an experienced some respiratory symptoms, "hard time breathing" along with coughing. Treatment of Solu-Medrol IV, Benadryl and Prelone were given. The pt reportedly recovered from this experience. From additional information received on 1/10/00, the correct IPOL lot number (P0658) was provided. Y Y 11/11/1999 11/11/1999 0 NONE PVT PVT URI U1999009850 1
0167292 03/14/2001 MD 3.0 3 M 02/02/2000 It was reported that a 3 year old male pt received vaccines on 8/26/99. Reportedly, about 20 minutes, post vax, the pt became irritable, began digging at ears, developed congested eyes and spitting. The pt also developed hives on trunk and back, no wheezing. The pt was sent to the ER where he received SC epi and Benadryl. The pt was hospitalized in he ER "short-stay unit" for 6 hours. Reportedly, the pt recovered from this experience. From correspondence received on 1/28/00, amendments in the reporter's address and in the amount of time the pt was in the "short-stay unit" was provided. Y Y 08/26/1999 08/26/1999 0 NONE PUB PUB NONE NONE U1999009870 1
0167293 03/14/2001 NY 0.5 0 .5 M 12/29/1999 A nurse reported that a 6 month old male received vaccines on 5/21/99 and the infant developed diarrhea which resolved within 24 hours. Follow-up information received from the physician on 9/16/99, stated that the infant received Rota Shield and ActHIB on 5/21/99 and that the infant remained recovered." No additional information was provided from correspondence returned on 12/16/99. Y 05/21/1999 05/25/1999 4 UNK PVT PVT NONE "CDSSS Medical History: Hemophilia A." U1999010090 1
0167294 03/14/2001 KS 0.2 M 12/07/1999 It was reported that a 2 month old male received a DTAP-Tripedia vaccination on 9/27/99 and reportedly, that same day, the pt experienced inconsolable crying for 2 hours. The pt was given Tylenol and the experience resolved. It was stated, "The doctor is not concerned and is not filing a VAERS report". Y 09/27/1999 09/27/1999 0 UNK UNK U1999010130 1
0167295 03/14/2001 CO 1.0 1 .5 F 02/15/2000 It was reported that an 18 month old female was vaccinated on 11/22/99. On 11/23/99, the pt had generalized hives without respiratory involvement. From correspondence received on 2/15/00, it was reported that the pt recovered from this experience. Additional vaccine and responsible physician information was also provided. Y 11/22/1999 11/23/1999 1 NONE PVT PVT NONE NONE U1999010350 1
0167296 03/14/2001 TX 1.9 1 .9 M 02/08/2000 It was reported that a 23 month old male received TriHIBit (Tripedia and ActHIB combined) on 11/30/99. Reportedly, the pt had complaints of cellulitis beginning on 12/1/99. There is no additional information at this time. From additional correspondence received on 2/3/00, it was reported that the pt recovered from this experience. Additional pt and responsible physician information was also provided. Y 11/30/1999 12/01/1999 1 PVT PVT U1999010480 1
0167297 03/14/2001 TX 1.4 1 .6 F 02/02/2000 It was reported that a 17 month old female received TriHIBit vaccine on 12/3/99. Reportedly, the pt experienced cellulitis beginning on 12/4/99. There is no additional information available at this time. From correspondence received on 1/31/00, it was reported that the pt recovered from this experience. Also, reported, "reviewed, no additional information at this time." Y 12/03/1999 12/04/1999 1 PVT UNK U1999010490 1
0167299 03/14/2001 CA 0.2 0 .2 M 02/29/2000 "A physician reported that a 2 month old infant received vaccines on 6/7/99. On 6/10/99, the infant developed a fever of up to 102F and diarrhea. The infant was seen in ER. The infant was discharged to home and prescribed Rocephin IM for 3 days. As of 6/28/99, the infant's stools were still positive for occult blood." From correspondence received on 2/22/00, it was reported that the stool guaiac was finally negative on 7/5/99 (4 weeks, post vax). The pt reportedly recovered from this experience. Additional pt and vaccine information was also provided. Follow up #1 (6/5/02): during internal auditing of all files, it was deemed necessary to amend the report by updating the adverse event coding (added diarrhea). Y Y 06/07/1999 06/10/1999 3 Hemoglobin-8.1; hematocrit-23.7; stool guaiac-positive for occult blood; LP, Blood and Urine cultures-all neg. PVT OTH NONE NONE U1999011040 1
0167300 03/14/2001 AL 0.21 0 .2 M 01/24/2000 A physician reports a pt one to two days post vaccine developed green stools every hour. Y Y 04/09/1999 04/10/1999 1 Rotazyme test/negative PVT PVT NONE NONE U1999011050 1
0167301 03/14/2001 NJ 0.4 0 .5 M 01/24/2000 It was reported that pt post vaccine developed fever of 105F. Y U 12/16/1999 12/16/1999 0 PVT PVT U199901115 1
0167302 03/14/2001 NJ 0.4 0 .5 M 12/29/1999 It was reported post vaccine pt developed uncontrollable screaming for 5 hrs. U 12/10/1999 12/10/1999 0 UNK UNK U199901116 1
0167303 03/14/2001 IL 0.5 0 .5 F 02/02/2000 It was reported that post vaccine pt experienced 6 episodes of tremors, each lasting under one min and shaking uncontrollably. It was reported from physician "I did not associate the complaint of shaking episodes with the vaccine. U 09/01/1999 09/04/1999 3 EEG 9/30/99 PVT PVT feeding problems U200000001 1
0167305 03/14/2001 CO 0.6 0 .6 F 01/20/2000 It was reported post vaccine pt developed cellulitis. U 01/06/2000 01/08/2000 2 UNK UNK U200000024 1
0167306 03/14/2001 IL 1.5 F 01/21/2000 It was reported post vaccines pt developed large local reaction of redness and swelling. Y U 01/12/2000 01/13/2000 1 UNK UNK U200000029 1
0167307 03/14/2001 KS 1.2 1 .2 M 06/28/2001 It was reported that a 14 month old male patient received a Trihibit vaccination (combination of Tripedia and ActHIB) on 01/14/00 Reportedly that same day, the patient developed generalized hives, itching and swelling of the eyes and face. The patient was given Benadryl as treatment. From correspondence received 06/13/01 stated that the patient recovered from this experience. This case is closed. Y 01/14/2000 01/14/2000 0 Physician exam diagnosis Hives 01/14/00 PVT PVT NONE NKA U200000030 1
0167308 03/14/2001 CO 0.3 0 .3 M 02/14/2000 It was reported post vaccine pt developed inconsolable crying for 2 hrs. Y 11/22/1999 11/22/1999 0 PVT PVT U200000043 1
0167309 03/14/2001 FL 0.5 0 .5 F 03/09/2000 A physician reports post vaccine pt developed fever as high as 102F. Pt also developed 2 episodes of diarrhea, vomited once and developed macular rash on her extremities. Y Y 04/29/1999 05/01/1999 2 PVT PVT CDSSS medical history unknown U200000058 1
0167310 03/14/2001 NY 1.25 1 .3 M 02/08/2000 It was reported post vaccine pt developed mottled erythema right thigh and left leg. U 01/27/2000 02/02/2000 6 UNK UNK U200000068 1
0167311 03/14/2001 VA 0.3 0 .4 M 02/24/2000 It was reported post vaccine's pt developed scattered areas of pink/red lesions on lower extremities. Y U 02/02/2000 02/03/2000 1 PVT UNK U200000069 1
0167312 03/14/2001 OH 0.53 0 .5 M 03/03/2000 It was reported post vaccine pt developed a local reaction of redness and swelling. U 02/02/2000 02/03/2000 1 PVT OTH Reglan, Tagament Non regurgative reflux U200000073 1
0167313 03/14/2001 OH 1.5 1 .6 F 03/03/2000 It was reported post vaccine pt developed local reaction of redness and swelling. U 02/02/2000 02/03/2000 1 Normal 18 month check up PVT UNK U200000074 1
0167314 03/14/2001 OH 1.5 1 .5 F 06/18/2002 It was reported post vaccine pt developed local reaction of redness and swelling. Follow up 5/14/02: during internal review of all files, it was deemed necessary to amend the report (corrected vaccination date to 2/3/00 adn the reaction date to 2/4/00 at it appears on the initial contact report). U 02/03/2000 02/04/2000 1 Normal 18 month check up PVT OTH U200000075 1
0167315 03/14/2001 OH 1.5 1 .6 F 03/03/2000 It was reported post vaccine pt developed local reaction of redness and swelling. U 02/11/2000 02/12/2000 1 PVT UNK RAD U200000076 1
0167316 03/14/2001 MN 0.3 0 .3 F 03/16/2000 It was reported post vaccine's pt developed a generalized rash which appeared to be erythema multiforme, it started at the injection site and developed over the legs, trunk and head. Y 01/05/2000 01/06/2000 1 PVT PVT Zantac Born at 36 weeks, gestational age, gastroesophageal reflux. U200000100 1
0167317 03/14/2001 SC 0.2 0 .2 F 03/16/2000 It was reported post vaccine's pt developed a knot at the injection site. Y 02/22/2000 02/22/2000 0 PVT PVT Amoxil, Albuterol syrup U200000110 1
0167318 03/14/2001 SC 0.2 0 .2 F 07/03/2001 It was reported that a 2 month old female received a Tripedia, an ACTHIB and an IPOl vaccination on 02/22/00. Reportedly on 02/23/00, a knot formation developed at the injection site of the right thigh. From mailed follow up correspondence received on 06/19/01, it was stated that the patient recovered from this expereince. Additional patient, vaccine, resaponsible physician and vaccine administrator informatioin was provided. "No further information available regarding this patient or this case." This case is closed. Y 02/22/2000 02/23/2000 1 PVT PVT NONE NKA U200000113 1
0167319 03/14/2001 SC 1.25 1 .3 F 03/16/2000 It was reported post vaccine's pt developed a local reaction of redness and swelling at the injection site, the thigh was warm and swollen. Y 02/24/2000 02/24/2000 0 PVT PVT ROM U200000116 1
0167322 03/14/2001 AL 1.25 1 .3 M 03/30/2000 Report of injection site reaction, rash, edema, thigh hot to touch, causing pt to limp. Y 02/23/2000 02/23/2000 0 PVT PVT Well child check VSD (ventrical septal defect) at birth U200000134 1
0167323 03/14/2001 AL 1.3 1 .3 F 03/30/2000 It was reported post vaccine's pt developed redness of the left leg that was warm to touch. Y 03/01/2000 03/01/2000 0 PVT UNK URI U200000135 1
0167324 03/14/2001 AL 1.4 1 .5 F 03/29/2000 It was reported post vaccine's pt's thigh became red, swollen and hot to touch. Y 02/29/2000 02/29/2000 0 PVT PVT URI/BOM U200000136 1
0167325 03/14/2001 NY 1.5 1 .5 F 04/26/2000 It was reported post vaccine's pt developed an area of redness that was warm to touch. Y 03/03/2000 03/06/2000 3 PVT PVT U200000153 1
0167326 03/14/2001 NY 1.5 1 .5 M 04/26/2000 It was reported post vaccine's pt developed warmth and redness of his right arm. Y 02/03/2000 02/05/2000 2 PVT OTH U200000154 1
0167327 03/14/2001 NY 1.5 1 .5 F 06/17/2002 It was reported post vaccine's pt developed erythema and swelling of the R upper tricep area that was warm to touch. Follow up 5/14/02: during internal review of all files, it was deemed necessary to amend the report by updating the adverse event coding (added vasodilatation). Y 02/22/2000 02/24/2000 2 PVT PVT U200000155 1
0167330 03/14/2001 NM 4 M 04/03/2000 It was reported that a male patient received a Tripedia, an IPOL and a MMR vaccination on 3/27/00. Reportedly 18 hours after immunizations the patient developed a fever of 104F. Additional information is being requested. Follow up #1 (7/24/02): during internal review of all files, an onset date was identified from source document or other sourses. It was deemed necessary to amend the report by updating the onset date to 18 hours post vaccination. U 03/27/2000 03/27/2000 0 UNK UNK U200000198 1
0167331 03/14/2001 NY 1.5 1 .6 M 04/26/2000 It was reported post vaccine pt developed a large area of redness under his L arm the size of an orange that was warm to touch. Y 03/15/2000 03/17/2000 2 PVT PVT U200000200 1
0167332 03/14/2001 NJ 1.3 1 .4 M 04/18/2000 It was reported that a 16 month old male patient received a Tripedia and an ActHIB vaccination on 3/28/00. Reportedly on 3/29/00, the patient's arm became swollen and red. On 3/30/00, the patient's lips and feet turned purple per patient's mother. The patient was brought to the physician's office for a visit in the late morning. The patient had a temperature of 102.5 F and was shivering, increased heart rate. The patient sent to the emergency room via ambulance, lips and feet blue. From correspondence received at manufacturer on 4/17/00, additional patient information was provided. Follow up #1 (6/14/02): during internal auditing of all fieles, it was deemed necessary to amend the report by updating the adverse event coding (added tachycardia, skin discoloration and chills). Additional also resulted in re-ranking of events which changed the AE onset date. Y U 03/28/2000 03/29/2000 1 PVT PVT U200000201 1
0167333 03/14/2001 NM 1.5 1 .6 F 04/04/2000 It was reported post vaccine's pt developed a fever of 104F, also experienced joint swelling of the knees and ankles. U 03/27/2000 03/28/2000 1 UNK UNK U200000203 1
0167334 03/14/2001 NJ 2.0 2 .0 M 04/18/2000 It was reported post vaccine's pt developed a low grade fever of 99F and redness to the R upper thigh. U 03/28/2000 03/30/2000 2 PVT PVT U200000204 1
0167337 03/14/2001 NY 1.5 1 .6 M 06/17/2002 It was reported that a male patient received a TriHibit (combination Of Tripedia and ActHib) and IPOL vaccination on 03/31/00. Reportedly sometimes after the vaccination, the patient developed a local reaction. No specifics provided. Additional information is being requested. From correspondence received on 04/25/00, it was reported that the patient developed erythema and swelling which progressed from the shoulder to elbow,lasting 48 hours and then resolved. The patient was afebrile but anorexia after application but was well when reaction resolved. From mailed follow-up correspondence received on 06/12/01, the patient's age and the adverse event onset date were provided. The case is closed. Follow up 06/14/02; during internal auditing iof all files, it was deemed necessary to amend the report by updating the Adverse Event coding (added anorexia) Y 03/31/2000 PVT UNK NONE NKA U200000209 1
0167338 03/14/2001 NJ 2.0 1 .5 F 06/27/2001 It was reported that a female patient received a TriHibit (combination of Tripedia and ActHib) and an IPOL vaccination on 03/15/00. Reportedly sometimes after the vaccination the patient developed a local reaction. No specifics provided. Additional information is being requested. From corrspondence received on 04/25/99, it was reported that the patient developed an erythematous area around thre injection site and swelling up to the elbow. The reaction lasted 48-72 hours. The patient was placed on hymenitis for possible cellulitis, Patient did well after reaction resolved. From mailed correspondence received on 06/12/01 started that the patient recovered from this experience. The patient's age and the adverse evrent onset date was also provided. Y 03/15/2000 03/16/2001 366 PVT UNK NONE NKA U200000210 1
0167339 03/14/2001 IL 0.2 0 .2 F 06/28/2001 It was reported that a 2 month old patient received a Tripedia, an ActHIB and a Prevnar (Lederle) vaccination on 04/12/00. Reportedly sometimes after the vaccination, the patient developed inconsolable crying for more than two hours and also pain at the injection site. The patient was seen in the ER. From correspondence received on 05/05/00, additional patient, vaccine and responsible information was provided From mailed follow-up correspondence received 06/13/01 stated, "No further informnation at this time." This case is closed Y U 04/12/2000 NONE PVT UNK NONE U200000269 1
0167340 03/14/2001 UT 0.2 0 .2 M 05/03/2000 It was reported that a 2 month old male patient received a Tripedia, an ActHIB, an IPOL and a Hepatitis B vaccination on 4/11/00 at 12:00. Reportedly at 3:30PM that same day, the patient developed unconsolable screaming until 12:00AM. The patient would not eat until 4:00am on 4/12/00 and was very restless when he fell asleep that morning. As of 6:00PM on 4/12/00, the patient is improving. No additional information was provided from correspondence received at manufacturer on 5/2/00. Follow up #1 (7/3/02): during internal review of all files, it was deemed necessary to amend the report by updating the adverse event coding (added anorexia and nervousness). N 04/11/2000 04/11/2000 0 PVT PVT U2000002700 1
0167341 03/14/2001 TX 1.25 1 .3 M 04/20/2000 It was reported 24 hrs post vaccine pt developed fever. U 04/17/2000 04/18/2000 1 UNK UNK U2000002830 1
0167342 03/14/2001 GA 5.0 5 M 07/31/2000 Within 48 hours of the vaccine, the pt developed a sterile abscess on his left thigh at the injection site. Further information has been requested. From additional correspondence received on 7/18/00, it was reported that the pt recovered from this experience. Y 04/24/2000 04/26/2000 2 PVT PVT U2000002960 1
0167344 03/14/2001 AL M 05/03/2000 It was reported that a pt (1 of 6) post vaccine developed fever, inconsolable crying, and swelling and induration at the injection site, hot to touch. Further information requested. From mailed follow-up #1 correspondence received on 16-Jul-2001, it was reported that 60-72 hours after administratration of DTaP, Hib and IPV, the patient's mother called the physician's office stating her child had 2-3 inches of swelling in legs (towards knee), heat and a little redness. Dr felt this could be due to child's homophilia and advised mother to seek treatment at the hospital's emergency room. The patient reportedly recovered from this experience. This case is closed. U 05/12/1996 05/15/2000 1464 UNK UNK U200000302 1
0167345 03/14/2001 AL U 05/03/2000 A pt (2 of 6) post vaccine developed fever, inconsolable crying and swelling and induration of injection site that was hot to the touch. U UNK UNK U200000303 1
0167346 03/14/2001 AL U 05/03/2000 Pt (3 of 6) reported post vaccine developed fever, inconsolable crying, swelling and induration at injection site was hot to the touch. U UNK UNK U200000304 1
0167347 03/14/2001 AL U 05/03/2000 Pt (4 of 6) reports post vaccine developed fever, inconsolable crying, swelling and induration at injection site that was hot to touch. U UNK UNK U200000305 1
0167348 03/14/2001 AL U 05/03/2000 Pt (5 of 6) reports post vaccine developed fever, inconsolable crying and swelling and induration at injection site that was hot to touch. U UNK UNK U200000306 1
0167349 03/14/2001 AL U 05/03/2000 Pt (6 of 6) reports post vaccine developed fever, inconsolable crying and swelling and induration at injection site that was hot to touch. U UNK UNK U200000307 1
0167351 03/14/2001 PA 5.0 5 M 05/15/2000 It was reported post vaccine pt developed 5-6cm inflamed raised area of erythema. U 05/09/2000 05/09/2000 0 PVT PVT Prelone RAD U200000335 1
0167354 03/14/2001 NJ 4.0 4 M 06/28/2001 It was reported that a male patient received a Tripedia, an IPOL and a MMR (unspeicified) vaccination on 02/19/00. Reportedly sometimes MMR (unspecified) vaccinations on 02/19/00.Reportedly sometime after the vaccinations the patient's right upper arm became swollen, hot and tender. From his elbow to shoulder also developed hyperpigmentation with macular papular lesions. Further information requested. From additional information recived on 06/05/00, it was reported that on 02/29/00, the patient's " right arm became swollen and tender to elbow with above symptoms noted" Additional patient, responsible physician and vaccine information was also provided. From additional correspondence received on 07/13/00, no additional information was provided. No further information is anticipated for the repoirt. The case is closed. From mailed folloew-up correspondence received on 06/13/01 stated the patient recovered from this experience. Thre adverse event onset date was also provided. No further information is anticipated. This case is closed. Y 02/19/2000 02/20/2000 1 NONE PVT PVT NONE NKA U200000342 1
0167355 03/14/2001 MO 5.0 5 M 06/13/2000 It was reported post vaccine pt noted swelling and redness at injection site. Y 05/03/2000 05/04/2000 1 PVT PVT Adek vitamins, Albuterol, Nasocert URI Cystic fibrosis U200000343 1
0167356 03/14/2001 IL 0.2 M 05/17/2000 Reported post vaccine's pt became lethargic. U 03/09/2000 03/09/2000 0 UNK UNK U200000345 1
0167357 03/14/2001 CA 0.49 0 .5 F 05/23/2000 It was reported 1 week post vaccine pt developed lump at injection site U 05/12/2000 05/19/2000 7 UNK UNK U200000355 1
0167358 03/14/2001 CA 0.3 0 .3 F 06/15/2000 It was reported one wk post vaccine pt developed a lump at injection site. U 05/12/2000 PVT PVT U200000356 1
0167359 03/14/2001 NJ 5.0 5 F 06/15/2000 It was reported post vaccine's pt experienced swelling, redness and tenderness from shoulder to elbow. U 05/16/2000 05/18/2000 2 PVT PVT Flovent, Albuterol Asthma Asthma U200000358 1
0167360 03/14/2001 AL 0.2 0 .2 F 08/22/2000 It was reported post vaccine's pt started crying and cried through the evening. Pt developed a temp of 103F. Pt right thigh at injection site became swollen and blush color with light streaking. Y 05/18/2000 05/18/2000 0 MIL PUB Lactose intolerance U200000414 1
0167361 03/14/2001 NY 1.6 1 .6 M 08/17/2000 Approximately 30 minutes post vax, the pt developed hives, a rash over the entire body and swelling of upper lip. The pt was treated with Solu-Medrol, Benadryl. the pt reportedly recovered from this experience. No additional information was provided. No further information is anticipated for this report. Y Y 06/05/2000 06/05/2000 0 NONE PVT PVT NONE NONE U2000004690 1
0167362 03/14/2001 CA 0.5 0 .5 F 07/31/2000 Sometime following the vax, the pt developed a lump at the injection site. It was reported that the pt recovered from this experience. Y 05/12/2000 UNK UNK NONE U2000004790 1
0167363 03/14/2001 FL 5.0 U 07/11/2000 Sometime following vaccination, the pt developed a large local reaction of redness and swelling. The pt was treated with antibiotics. Further information requested. U UNK UNK U2000005330 1
0167364 03/14/2001 CA 1.25 1 .3 F 08/10/2000 At 10:40 the same day, the pt developed an injection site reaction that included 3x3" erythema, which was painful to the touch and severe urticaria. The pt was given 3/4 tsp of Benadryl and was observed. The reaction was gone after 72 hours and the pt recovered. Follow up information received 10/31/2000 states no further information is anticipated for this report. The case is closed. Y 07/21/2000 07/21/2000 0 PVT PVT NONE NONE U2000006020 1
0167365 03/14/2001 HI 0.5 0 .5 M 08/16/2000 On 7/27/00, the pt developed redness and swelling of the right thigh. On 7/28/00, the pt developed hives, erythema multiform. Further information has been requested. Follow up received 09/26/2000 states the patient developed the erythema multiforme on 7/30/2000. The patient was given Benadryl and Prevone as treatment. These symptoms resolved on 08/04/2000. Y 07/25/2000 07/26/2000 1 UNK UNK U2000006350 1
0167367 03/14/2001 TX 6.0 5 F 08/22/2000 Reportedly, the pt developed a local reaction 4-inches in diameter that was warm to the touch and itchy approximately 40 hours after the vax. Further information is requested. Follow up on 10/25/02: "From follow up telephone call with the receptionist from the clinic, it was stated that they do not know a person by the name. Therefore, no further information can be obtained. This case is closed." U 08/10/2000 UNK UNK U2000006430 1
0167368 03/14/2001 GA 1.5 F 08/22/2000 Reportedly on 8/16/00, the pt developed redness and swelling of the right thigh. The pt's mother contacted the physician's office and was instructed to watch the site and check for fever and treat as needed. Follow up received 09/22/2000 states no further information is anticipated for this report. The case is closed. U 08/16/2000 UNK UNK U2000006440 1
0167369 03/14/2001 GA 5.0 5 M 08/22/2000 Reportedly on 8/15/00, the pt developed redness and swelling of the injection site of the left deltoid. Further information has been requested. Follow up data received 09/29/2000 states no further information is anticipated for this report. Case is closed. U 08/14/2000 08/15/2000 1 UNK UNK U2000006450 1
0167371 03/14/2001 GA 3.0 3 F 08/25/2000 Reportedly 48 hours post vax, the pt developed a warm, red, painful area at the injection site. Follow up data received 10/05/2000 states no further information is anticipated for this report. Case is closed. U 08/17/2000 08/19/2000 2 UNK UNK U2000006690 1
0167372 03/14/2001 GA 5.0 5 M 06/28/2001 It was reported that a male patient recived a Tripedia and a MMR (unspecified) vaccination on 08/09/00 Reportedly somtimes after the vaccination, the patient developed a 24 inch raised area at the injection site. Further information requested. From follow-up correspondence received on 10/10/00, additional patient, responsible physician and vaccine information was proivided. No further information is anticipated for this report. From mailed follow-up correspondence received 06/13/02, it was reported that the patient recovered from this experience. "No further information available regarding thispatient or this case." This case is closed. Y 08/09/2000 PVT PVT NKA U2000006740 1
0167084 03/15/2001 GA 24.0 24 F 03/09/2001 Information has been received from a healthcare professional and a 24 year old Caucasian female consumer who on 6/30/00, was vaccinated with 1 dose of varicella virus vaccine live. It was noted that the pt was not treated for varicella antibodies prior to vaccination. On 7/6/00, the pt learned that she was pregnant. At 6 weeks, the pt had an ultrasound done which was normal. On 8/26/00, at approx. 9 weeks from the LMP, the pt had a spontaneous abortion. It was unknown if the products of conception were examined or if the fetus was normal. There were no maternal adverse events. No further information is available. Follow up on 06/29/2001: "Lot # for vaccine 1 is not provided." Y U 06/30/2000 08/26/2000 57 Ultrasound on 8/1/00-nml PVT OTH NONE Pregnancy-LMP unknown; asthma; hypertension; allergy to PCN WAES00070520 1
0167086 03/15/2001 NY 2.0 2 .9 F 03/07/2001 This patient had probable seizure activity, eyes stared, decreased tone, voided for 3 minutes duration. Had Prevnar injection 4 days prior to event. History of fever, vomiting, diarrhea, URI sickness. Y 1 Y 03/01/2001 03/05/2001 4 CT of head-WNL; Ca-10.1; UA-WNL; EEG-pending; Conditions of recording: Asleep; Normal Activity: Alpha-basic background rhythm of 2-4 cycles per sec. slow waves up to 100 microvolts diffusely distributed. Beta-25-30 cycles per sec. up to 10 microvolts. Abnormal Activity: None; Hyperventilation: Omitted; Photic Stimulation: Omitted; Impression: Normal sleep record; OTH UNK Otitis Media Otitis Media; History of fever, vomiting, diarrhea, URI symptoms. 1
0167156 03/15/2001 NM 39.0 38 F 02/09/2001 Was dx'd with "unatic skin rash" by MD on 1/31/01. Was treated with a steroidal antihistamine IV in the hip. Was told that 1% of Hep-B vaccinees experience this reaction. Had a rash on both arms, legs, trunk and back, all within 2-3 days of vaccine. Had severe itching with rash. Complained of slight dryness of skin on elbows and hips possibly prior to vaccine. No complaints of reaction to prior Hep-B vaccine. Y Y 01/17/2001 01/19/2001 2 NONE PUB OTH NONE NONE NONE NM020001 1
0167157 03/15/2001 CA 17.0 17 F 02/28/2001 Pt states onset of fever, myalgias and sore arm about 3 hours, post vax, while at work. On 2/27/01, in with complaint of sore throat, fever of 102.5F, myalgias and sore arm. No erythema. Edema at injection site. Improved on 2/28/01. Viral syndrome versus vaccine reaction. Y U 02/26/2001 02/26/2001 0 NONE PUB OTH NONE NONE NONE 1
0167158 03/15/2001 NY 1.25 1 .3 M 03/08/2001 Rash dx'd by MD as vaccine induced measles on 3/7/01. Elevated temperature on 3/6/01 and 3/7/01 between 99F (R) and 100F (R). Pt is recovering. BP-98/62. U 02/26/2001 03/05/2001 7 NONE OTH PVT Diazepam, Ferrous sulfate; Mylicon, MVI plus fluoride; acetaminophen for fever; albuterol by nebulizer; Baclofen; Zantac NONE Profound psychomotor retardation, seizure disorder, status post perinatal asphyxia, who has had global developmental delay as well as spasticity and hearing loss. He has had speech therapy. Diet consists of tube feeds consisting of Pediasure with H2o flush per the G-tube. Pt is small for age. Previously dx'd with cerebral palsy, asthma, bronchopulmonary dysplasia. 1
0167159 03/15/2001 CA 12.0 11 F 03/13/2001 Swelling of glands in the cheeks and neck. N 02/22/2001 03/13/2001 19 PUB PUB 1
0167192 03/15/2001 NY 1.5 1 .3 F 03/06/2001 Post vax, she had a low-grade fever, no appetite, little energy and had a "dazed" look on her face. In the evening of 12/3/00, she had a fever of 104F. During this time period, (12/1/00-12/03/00) we gave her alternately, Tylenol and Motrin (children's). Y Y 11/30/2000 12/03/2000 3 NONE PVT PVT NONE NONE Eczema 1
0167215 03/15/2001 MD 46.0 44 F 03/04/2001 Onset of numbness/paresthesias of feet bilaterally. 10/27/98; onset fasciculations of calves bilaterally. On 10/29/98, onset exacerbation of carpal tunnel-like symptoms, bilaterally. In 1/99, Weakness/fatigability, low back, buttocks, and hip flexors noted.; 5/99, Motor abnormality of left foot noted; 8/00, Intrinsic muscle atrophy/weakness in both feet noted. Course: Numbness/paresthesias of feet progressed to proximal anterior legs by May/99; noted improvement in legs/feet sensory reactions in 3/00; intrinsic muscle atrophy/weakness in feet persists; have clawfoot-type deformity of left foot; weakness of low back, buttocks-essentially resolved. Note: At time of onset of neurologic symptoms in 10/98, still had tender SQ nodule from AVA. Y N 09/30/1998 10/26/1998 26 EMG on 1/99-acute denervation in paraspinal muscles at low lumbar/sacral levels bilaterally; EMG on 8/99-acute denervation intrinsic foot muscles bilaterally; acute and chronic denervation proximal muscles; DX; active polyradicular process involving lumbar and sacral roots bilaterally; EMG on 8/00-Diffuse axonalmotor sensory peripheral neuropathy; some improvement in sensory c/w 8/99. MIL MIL Dimetapp NONE NONE 1
0167218 03/15/2001 WA 62.0 62 F 03/02/2001 Persistent pain in left deltoid (now 3 M post injection); numbness down extensor of forearm and back of hand since then. Decreased light touch dorsal/above left hand, light touch intact over forearm. N 12/12/2000 12/12/2000 0 PVT OTH Levoxyl, Paxil, Diltiazem, Trazodone, Estratest Hypertension, hypothyroidism, menopause, GERD 1
0167415 03/15/2001 NY 11.0 11 F 03/07/2001 Information has been received from a physician concerning an 11 year old Hispanic female who on 01/09/00 was vaccinated with a 3rd dose of Hepatitis B vaccine recombinant. It was noted that at the time of vaccination, the patient had a sore throat and a cough and was diagnosed with an upper respiratory infection. On 01/11/00, the patient experienced right arm swelling, redness and a "hard to the touch" area about 30 mm in size. The patient was seen by a physician, no treatment was rendered. On 01/12/00 the patient recovered. Y Y 01/09/2000 01/11/2000 2 NONE UNK UNK NONE Cough, sore throat, upper respiratory infection Asthma WAES00010894 1
0167416 03/15/2001 PA 50.0 M 03/07/2001 Information has been received from a physician concerning a 50 year old male who on 12/06/99 was vaccinated with a 1st dose of Hepatitis B vaccine recombinant. On 12/07/99, the patient experienced respiratory symptoms, fever, headache, and cough. He recovered after one week. He was vaccinated with the 2nd dose of Hepatitis B vaccine recombinant on 01/06/00. He experienced respiratory symptoms, fever, headache and cough again, this time much worse than the first. The patient's symptoms persisted at the time of the report, five days after onset. It was also noted he received a flu shot in October 1999. No further information is available. N 12/06/1999 12/07/1999 1 OTH OTH Diuretic preparation Hypertension WAES00010932 1
0167417 03/15/2001 MI 18.0 18 F 03/07/2001 Information has been received from a health care professional concerning an 18 year old Caucasian female who on 01/04/00 was vaccinated with a 3rd dose of Hepatitis B vaccine recombinant. On 01/09/00, the patient complained of abdominal pain, a fever of 102.9 F, and swollen lymph nodes. On 01/11/00 she was seen by her physician and started on therapy with Cipro. Follow up information on 01/27/00 indicated that the patient was diagnosed with mononeucleosis. At the time of the report she was still complaining of abdominal discomfort and fatigue. No further info is available. Y N 01/04/2000 01/09/2000 5 UNK UNK UNK UNK WAES00011045 1
0167418 03/15/2001 CA 9.0 F 03/07/2001 Information has been received from a physician concerning a 9 year old female patient who on 01/07/00 was vaccinated with a 1st dose of Hepatitis B vaccine recombinant. On 12/07/99, the patient subsequently experienced mild arthralgia of the hips. She sought unspecified medical attention. No further information is available. Y U 01/07/2000 UNK UNK UNK UNK WAES00011835 1
0167419 03/15/2001 IL 35.0 35 F 03/07/2001 Information has been received from a registered nurse concerning a 35 year old Caucasian female who on 08/01/99 was vaccinated with a 5th dose of Hepatitis B vaccine recombinant. Subsequently the patient "seemed to have a worsening of multiple sclerosis. The patient experienced flushing, redness, and warmth from the arm to the neck." The patient sought unspecified medical attention. Follow up info from a registered pharmacist indicated that on 01/12/00, the patient developed "numbness, tingling, paresthesia of the right arm which extended in to her shoulder and neck and then became generalized with myalgia and weakness." Subsequently, the patient recovered. Y Y 08/01/1999 01/12/2000 164 UNK UNK Ibuprofen, Avonex, Propranolol. Multiple sclerosis WAES00012256 1
0167420 03/15/2001 TX M 03/07/2001 Information has been received from a registered nurse concerning a male who on 12/26/99 was vaccinated with a 3rd dose of Hepatitis B vaccine recombinant. Concomitant therapy included a 2nd dose of Hepatitis A vaccine. On 12/26/99, the patient experienced arm soreness with radiation of pain lower into the arm. There were no objective signs or symptoms. It was decided the patient had "either tendinitis with accidental nick of tendon sheath or coincidental tendinitis". NSAID's were recommended. Subsequently, the patient recovered. It was noted he "had two vaccine together in same arm previously with no problem". No further information is available. Y 12/26/1999 12/26/1999 0 PVT PVT UNK WAES00012390 1
0167421 03/15/2001 WI 48.0 M 03/07/2001 Information has been received from a woman concerning her husband, a 48 year old male who in 12/99 was vaccinated with the 2nd dose of Hepatitis B vaccine recombinant. On approximately 01/06/00, the patient experienced a rash "all over, not just in a specific area". The rash started on the patient's hands. The rash was itchy, and he had 30 spots on his body. They were pus filled and irregular in shapes. They were not huge, and were smaller than a dime. The reporter stated "if he did not already have the chicken pox I would think it was that". The patient's varicella-like rash persisted. No further information is available. N 01/06/1999 UNK UNK UNK UNK WAES00012519 1
0167422 03/15/2001 NY M 03/07/2001 Information has been received from a physician concerning a male who was vaccinated with a 1st dose of Hepatitis B vaccine recombinant. Several hours later, the patient experienced respiratory infection, and swelling at the injection site, and a fever of 39 degrees C. The patient was taken to the ER. No injection site symptoms were noted at the ER. The patient's blood pressure was normal. The patient experienced "some respiratory problems that were indicative of a respiratory infection". A diagnosis or respiratory infection was made. The physician did not believe the symptoms were related to Hepatitis B vaccine recombinant. No further information is available. Y U OTH OTH UNK UNK WAES00012603 1
0167423 03/15/2001 TX 2.0 F 03/07/2001 Information has been received from a consumer concerning a 2 year old female patient who in 12/99 was vaccinated with a 1st dose of Hepatitis B vaccine recombinant. Subsequently, the patient developed a fever, an upper respiratory infection, and coughing. The reporter indicated that her granddaughter's experiences were caused by thimerosal. "The patient sought unspecified medical attention. Additional information has been requested. Y U OTH OTH UNK UNK WAES00020138 1
0167424 03/15/2001 CA 9.0 9 M 03/07/2001 Information has been received from a physician concerning a 9 year old Black male who on 01/06/99 was vaccinated with a 1st dose of Hepatitis B vaccine recombinant. Subsequently, the patient experienced spots and itching at the injection site over the entire arm. There was no reported pustules or drainage. The patient recovered approximately 2 weeks after onset of symptoms. The patient's mother brought him in for the second vaccination and the physician deferred the second shot. No further information is available. Y Y 01/06/1999 01/13/1999 7 PUB PUB UNK UNK WAES00020154 1
0167425 03/15/2001 IL 26.0 F 03/07/2001 Information has been received from a physician concerning a 26 year old female who was vaccinated with a 1st dose of Hepatitis B vaccine recombinant. The next day the patient developed two coin-shaped lesions on one arm and one on the other. These lesions were raised and erythematous, but not pruritic. The patient sought unspecified medical attention. Follow up info indicated that subsequently, the patient's symptoms resolved without treatment. Additional follow up info indicated the patient subsequently received a second dose of Hepatitis B vaccine recombinant without an adverse reaction. Y Y UNK UNK UNK UNK WAES00020346 1
0167426 03/15/2001 CA 0.08 U Information has been received from a physician concerning a 7 week old male who on 01/24/00 was vaccinated with one dose of Hepatitis B vaccine recombinant. On 01/25/00, the patient presented to the physician and was diagnosed with erythema multiforme secondary to Hepatitis B vaccination. The child was not started on oral steroids and his mother was non-compliant with oral Benadryl. He was treated with cornstarch and oatmeal baths. The rash cleared totally without running a classical lengthy course. No further information is available. Y Y 01/24/2000 01/25/2000 1 UNK UNK UNK WAES00020456 1
0167427 03/15/2001 PA 22.0 22 M 03/07/2001 Information has been received from a registered nurse concerning a 22 year old Caucasian male patient who was vaccinated with a 1st and 2nd dose of Hepatitis B vaccine recombinant on 08/10/99 and 09/08/99, respectively. After the 1st dose the patient experienced some minor soreness. "After the 2nd dose, the patient experienced muscle pain at the injection site. The patient was seen by a physician and an X-ray "did not show anything." The patient's muscle pain is persisting 5 months post-onset. Follow up information indicated that on 10/12/99, the patient was seen by a physician who reported that "on exam, the patient had a symmetrical shoulder shrug. He had full range of motion in his left shoulder without any difficulty. He had a negative Near, negative impingement. There was very slight edema noted over the medial aspect of his deltoid muscle. There were no sign of infection such as redness or swelling. There were no red streaks noted. There was no exudate noted. There was no puncture mark noted. There was no discomfort or palpitation over the AC joint. He had full ROM of his neck without any pain or pulling in his left shoulder. He had full ROM at the elbow without any pain or difficulty in the left shoulder. An x-ray was obtained to rule out abscess which was unofficially read as negative for abscess or fracture. "The physician did not believe that the patient's left deltoid pain was caused by Hep B vaccine. The physician felt that the left deltoid pain was caused by the patient's history of playing baseball, having tendonitis, and engaging in other aggressive activities. The patient was referred to an orthopedic specialist. It was noted that on 02/04/00, the patient received a 3rd dose of Hep B vaccine recombinant with "no lasting problem". Y U 08/10/1999 10/12/99 X-Ray - Neg. UNK UNK UNK Allergic to Penicillin, seasonal allergy, tendinitis. WAES00020469 1
0167428 03/15/2001 OK 21.0 F 03/07/2001 Information has been received from a 21 year old female who on 02/04/00 was vaccinated with the 1st dose of Hepatitis B vaccine recombinant. Concomitant therapy included a 1st dose of Varicella Virus Vaccine Live. On 02/04/00, the patient broke out in a sweat and almost passed out. She also "felt she may have a fever". No further information is available. U 02/04/2000 02/04/2000 0 OTH OTH UNK WAES00020473 1
0167429 03/15/2001 PA F 03/07/2001 Information has been received from a registered nurse concerning a female patient who in 1998 was vaccinated with one dose of Hepatitis B vaccine recombinant. In 1998 the patient experienced flu-like symptoms for 24 hours post vaccination. Unspecified medical attention was sought. Additional information has been requested. Y Y OTH OTH UNK UNK UNK WAES00020575 1
0167430 03/15/2001 KS F 03/07/2001 Information has been received from a registered nurse concerning a female patient who was vaccinated with Hepatitis B vaccine recombinant. Approximately one month post-vaccination, the patient experienced pain and swelling on one side of the face. No further information is available. U OTH OTH UNK UNK WAES00020842 1
0167431 03/15/2001 CA 40.0 40 M 03/07/2001 Information has been received from a consumer concerning a 40 year old male relative who on 03/15/99, 05/26/99, and 09/27/99 was vaccinated with a three dose series of Hepatitis B vaccine recombinant. On 10/15/99, the patient experienced a loss of strength and arthritis pain in his arms and fingers, atrophy of the arms and legs, loss of balance, and soreness in the upper back. At the time of the report he had lost twelve pounds. The patient sought unspecified medical attention. No further information is available. Y U 09/27/1999 10/15/1999 18 UNK UNK UNK UNK WAES00020953 1
0167432 03/15/2001 RI M 03/07/2001 Information has been received from a registered nurse concerning a male patient who in 1991 was vaccinated with one dose of Hepatitis B vaccine recombinant. Subsequently, in 1991 the patient developed a rash and edema. Unspecified medical attention was sought. Subsequently, three weeks later, the patient recovered. Follow up reported that no further information is available. Y Y OTH OTH UNK UNK WAES00020961 1
0167433 03/15/2001 WI 21.0 24 F 03/07/2001 Information has been received from a registered nurse concerning a 21 year old Caucasian female patient who on 01/13/00 was vaccinated with a 1st dose of Hepatitis B vaccine recombinant. Immediately following vaccination, the patient became pale, dizzy, diaphoretic and experienced a hot flush. Fifthteen minutes later the patient recovered. No further information is available. Y 01/13/2000 01/13/2000 0 NONE PUB OTH NONE NONE WAES00021404 1
0167435 03/15/2001 IN 11.0 M 03/07/2001 Information has been received from a health care professional concerning an 11 year old male patient who in October, 1999 and November, 1999 was vaccinated with the 1st and 2nd dose of Hepatitis B vaccine recombinant, respectively. On 01/05/00, the patient experienced an increase in LFT's, SGOT 103, and SGPT 184. On 01/13/00 SGOT 74, SGPT 156. On 01/27/00, SGOT 36, and SGPT 148, and on 02/07/00 SGOT 95, and SGPT 177. Upper limits of normal was SGOT 46 and SGPT 45. There was no baseline before them. Additional information has been requested. Y U 01/05/2000 01/05/00, the patient experienced an increase in LFT's, SGOT 103, and SGPT 184. On 01/13/00 SGOT 74, SGPT 156. On 01/27/00, SGOT 36, and SGPT 148, and on 02/02/00 SGOT 95, and SGPT 177. Upper limits of normal was SGOT 46, and SGPT 45. There was no baseline before them. UNK UNK UNK UNK WAES00021610 1
0167436 03/15/2001 CA 43.0 F 03/07/2001 The pt reports post vaccine she developed a rash all over the abdomen, slightly raised and itchy. Y U 02/10/2000 02/15/2000 5 UNK UNK WAES00021631 1
0167437 03/15/2001 CA 13.0 13 M 03/07/2001 Information was received from physicians office. Post vaccine pt experienced soreness at the injection site with warmth, redness, and swelling. Y U 09/02/1999 09/02/1999 0 UNK UNK WAES00021705 1
0167438 03/15/2001 SC 47.0 47 F 03/07/2001 Information received from a RN, post vaccine pt developed generalized fever,flu symptoms, a red polka dot rash and swelling on her L arm and both legs. It was noted that the pt was also being treated for a pulled muscle in the leg. Y 01/24/2000 02/18/2000 25 UNK UNK Norvasc Concurrent conditions: aspirin allergy, Cephalexin allergy, sulfa allergy, muscular strain. WAES00021827 1
0167439 03/15/2001 TX 11.0 F 03/07/2001 Information received from physician. Pt post vaccine experienced a generalized petechial rash on the neck and trunk. Y N UNK UNK WAES00021915 1
0167440 03/15/2001 VA M 03/07/2001 Information received post vaccine pt experienced arthritis like pain in the arm in which she recd the vaccine that went down her leg. The pt's arthritis like pain in the arm persisted. N UNK UNK WAES00021945 1
0167441 03/15/2001 PA 2.9 9 U Information received from a NP reports post vaccine pt developed a large wheal about the size of an orange at the injection site. It was noted the injection site was also swollen, red and hot to touch. Additionally, the pt's left upper arm was warm to touch. Y Y 02/21/2000 02/21/2000 0 PVT PVT Concurrent conditions: erythromycin allergy WAES00022212 1
0167442 03/15/2001 WA 48.0 47 F 03/07/2001 Information rec'd from HCP reports pt post vaccine reports she had joint pain in her R shoulder for approx 2 months. The pt's shoulder pain was dx as deltoid bursitis. The pt thinks the reaction is due to vaccine. Y U 07/15/1999 10/01/1999 78 10/99 neg hep b antibody titer, 12/99 neg hep b antibody titer. UNK UNK WAES00022334 1
0167443 03/15/2001 MD 19.0 19 M 03/07/2001 Information rec'd from physician reports post vaccine pt's liver function test was abnormal. Y Y 02/26/2000 hepatic function tests/ALT increased 2.5 times PVT PVT WAES00030010 1
0167444 03/15/2001 NY 45.0 M 03/07/2001 Information rec'd from physician reports pt with arthralgia of the knees, post vaccine experienced diffuse arthralgia. The physician did not feel that the arthralgia was caused by the vaccine. Y U UNK UNK arthralgia WAES00030048 1
0167445 03/15/2001 CO 52.0 52 F 03/07/2001 Post vaccine pt experienced redness and swelling at the injection site, felt sick, and experienced vomiting, headache, pallor and weakness. U 02/28/2000 02/29/2000 1 UNK UNK Tegretol,Dilantin,Effexor and prednione. hepatitis C, osteoarthritis, degenerative disc disorder, asthma, fibromyalgia, seizure disorder, intestinal bleeding, codeine allergy. WAES00030132 1
0167446 03/15/2001 DC U 03/07/2001 It was reported post vaccine pt experienced a fever of 103F. Y U UNK UNK WAES00030148 1
0167447 03/15/2001 OH F 03/07/2001 Information rec'd reports pt noted vaccine made my body turn against my spinal cord and it started swelling and I am lucky to be able to walk and talk again. almost died from the reaction. U UNK UNK WAES00030656 1
0167448 03/15/2001 PA 35.0 F 03/07/2001 The pt reports post vaccine she experienced a pigmentation change around the neck. The pigmentation change spread to the arms, chest, and belly. The pt took steroids for one month with no change. Y UNK UNK Pigmentary disorder~Hep B (Engerix-B)~1~1.00~In Patient WAES00030714 1
0167449 03/15/2001 FL 51.0 F 03/07/2001 Information was rec'd from a RN. Pt post vaccine developed a strange lupus like rash on her face that was mask like and her eyelids were swollen. Y N abnormal values= reticulocytes 3.3, LDH 1709,lymphocytes 11, neurophils 77.5, serum alanine aminotransferase test 157, serum aspartate aminotransferase test 200, serum cholesterol 283, serum triglyceride 295. UNK UNK WAES00030951 1
0167450 03/15/2001 NY F 03/07/2001 Information rec'd from HCP states a couple days post vaccine pt developed a fever, malaise and sinus infection. Y U UNK UNK WAES00030961 1
0167451 03/15/2001 WI 40.0 M 03/07/2001 Information rec'd from LPN states pt's hepatitis b antibody test was elevated at 8.5. Y U serum hepatitis B/ 8.5 UNK UNK WAES00031289 1
0167452 03/15/2001 KS 18.0 18 F 03/07/2001 Information rec'd from RN states pt with an allergy to Cefaclor that results in a rash. Immediately post vaccine pt developed injection site redness. It was noted the area was approximately 10cm x 4cm and was described as blotchy. It was also noted that the pt may have an active infection with hepatitis B. Y Y 03/14/2000 03/14/2000 0 PVT OTH drug allergy, hepatitis B WAES00031405 1
0167453 03/15/2001 IN M 03/07/2001 Information rec'd from HCP. Post vaccine the pt subsequently developed lesions on his tonsils and mono like symptoms. Y Y 04/17/1998 serum hepatitis B 2/9/00 negative titer/ serum hepatitis B 1/7/00 lower titer after 3 dose series. PVT PVT WAES00031419 1
0167454 03/15/2001 IL 10.0 10 M 03/07/2001 It was reported post vaccine pt developed a generalized maculopapular rash all over his body. The rash was slightly elevated, red, and pruritic. Y Y 03/15/2000 03/15/2000 0 PVT OTH UNK Crohn's disease WAES00031787 1
0167455 03/15/2001 NM 49.0 49 F 03/07/2001 It was reported that a pt with fibromyalgia post vaccine subsequently noticed that her fibromyalgia symptoms got worse. It was noted that the pt did not have a reaction after the 2nd vaccine. Y Y 02/17/2000 03/09/2000 21 PVT UNK UNK fibromyalgia WAES00031806 1
0167456 03/15/2001 WI 27.0 F 03/07/2001 Within 24 hours post vax, the pt complained of numbness and tingling of the left hand, left wrist pain and stiffness in the hand. On 3/16/00, the pt recovered from her experienced. No further information is available. Y U serum hepatitis B - low titer UNK UNK UNK UNK WAES00031808 1
0167457 03/15/2001 NJ 50.0 50 M 03/07/2001 Information rec'd from physicians office. Post vaccine pt developed multiple symptoms including insomnia, fever, malaise, nightmares, myalgia, sore throat, shaking, fatigue, and panic attacks. Y Y 03/14/2000 03/15/2000 1 PVT OTH aspirin allergic rhinitis, allergy erythromycin WAES00031964 1
0167458 03/15/2001 IL F 03/07/2001 It was reported post vaccine pt experienced nausea, vomiting and body malaise. Y U UNK UNK WAES00032129 1
0167459 03/15/2001 PA 33.0 33 F 03/07/2001 Information rec'd from HCP reports post vaccine the pt experienced a rash that was diagnosed a erythema multiforme. The reporter states that the pt did not experience any adverse reactions to the previous 2 vaccine. Y U 02/24/2000 UNK UNK Clindamycin, Retin-A acne WAES00032250 1
0167460 03/15/2001 MD 35.0 35 M 03/07/2001 Information rec'd from HCP. Post vaccine pt experienced headache, fatigue, nausea, diarrhea and lightheadedness. Y Y 02/01/2000 02/02/2000 1 UNK UNK WAES00032381 1
0167461 03/15/2001 MO F 03/07/2001 The pt experienced a red sore arm. The pt sought unspecified medical attention. Additional information has been requested. Y U OTH OTH UNK UNK WAES00032406 1
0167462 03/15/2001 TN 15.0 M 03/07/2001 On 2/1/00, the pt developed a red/hot area 3x3cm on the right arm. The pt sought unspecified medical attention and was treated with Cephalexin and hydroxine. The area greatly improved within 4-6 days and then completely cleared. No further information is available. Y Y 01/18/2000 02/01/2000 14 OTH OTH UNK allergy WAES00032473 1
0167463 03/15/2001 VA 47.0 F 03/07/2001 Subsequently the pt tested positive for opiates in her urine. The reporter notes that the level of opiates in the urine was "high". The pt sought unspecified medical treatment. Follow-up information indicated that the pt was in a substance abuse program and tested positive for opiates in her urine. The pt was vaccinated the day the urine sample was taken and the pt had denied using drugs. No further information is available. Y N urinalysis - opiates in urine - high PUB PUB Augmentin, estrogenic preparations, Levaquin WAES00032522 1
0167464 03/15/2001 MO 10.0 M 03/07/2001 On 3/18/00, the pt experienced shortness of breath while playing baseball and had to see his physician. Additional information has been requested. Y 03/16/2000 03/18/2000 2 OTH OTH UNK UNK WAES00032544 1
0167465 03/15/2001 IN 35.0 F 03/07/2001 Within hours post vax, the pt experienced malaise and was very tired. The next day she experience severe muscle weakness, joint achiness, GI upset and nausea. No vomiting or diarrhea was noted. The pt also experienced chills and fever up to 104 which was treated with acetaminophen. The fever resolved after 2 days and the rest of the symptoms resolved within 2 weeks. The reporting health care professional noted that the CDC stated this was not related at all to the vaccine. No further information is available. Y Y PVT PVT NONE allergy to erythromycin and PCN WAES00032667 1
0167466 03/15/2001 OH 12.0 12 F 03/07/2001 On 3/25/00 after the vax, the pt experienced a small amount of bleeding, a dime sized lump under the skin which progressed to a quarter size within minutes, and became swollen, By the time the pt left the office the area was 2 x 3 inches and was red and swollen. She was treated with ice and Benadryl. Subsequently she recovered. No further information is available. Y 03/25/2000 03/25/2000 0 OTH OTH UNK UNK WAES00032694 1
0167467 03/15/2001 CO 12.0 F 03/07/2001 On approximately 3/3/00 the pt experienced urticaria. The pt's urticaria persisted. Follow-up from the physician indicated she had not recollection of the pt's name. No further information is available. N 03/03/2000 UNK UNK UNK UNK WAES00040040 1
0167468 03/15/2001 NY F 03/07/2001 Subsequently the pt experienced injection site pruritus, redness and swelling for 3 days following the vaccination. No further information is available. Y Y OTH OTH UNK UNK WAES00040043 1
0167469 03/15/2001 MO F 03/07/2001 The pt developed a fever of 103, green loose stools, right upper quadrant pain which radiated to the left lower quadrant and a red sore arm. The pt sought unspecified medical attention. Additional information has been requested. Y U OTH OTH UNK UNK WAES00040046 1
0167470 03/15/2001 MO M 03/07/2001 Subsequently, the pt experienced a red sore arm. Additional information has been requested. It was noted that two other pt's also developed reactions post vax. Y U OTH OTH UNK UNK WAES00040047 1
0167471 03/15/2001 OH 23.0 23 F 03/07/2001 On 4/3/00, the pt developed a generalized raised, red, hot, itchy rash. She sought medical attention and was diagnosed with urticaria. The pt was treated with prednisone and cetirizine. At the time of the report, the pt's symptoms persisted and she felt as if she was on "fire". Follow-up information received on 5/17/00 from the consumer who is a medical assistant indicated that on 4/2/00 she woke up with raised itchy welts all over her body. She stated that her whole body was covered and felt like "it was on fire". she received therapy with "medications" from a physician. She indicated that she also experienced joint pain and lightheadedness and her legs swelled. The reporter stated that after 3 days she recovered. No further information is available. Y Y 03/31/2000 04/02/2000 2 PVT OTH NONE UNK WAES00040190 1
0167472 03/15/2001 CA F 03/07/2001 Immediately following vaccination, the pt experienced tremors and 48 hours later became dizzy. She sought unspecified medical attention. No further information is available. Y U UNK UNK UNK UNK WAES00040210 1
0167473 03/15/2001 FL M 03/07/2001 Subsequent to receiving the first two doses in the serious, the pt began taking creatine monohydrate. On the day following vaccination with the third dose, the pt ate breakfast and then a few hours later experienced a headache and nausea. The pt did not seek medical attention. Additional information has been requested. U OTH OTH creatine allergy to PCN WAES00046302 1
0167474 03/15/2001 CO 37.0 17 M 03/07/2001 The pts prostatic enlargement worsened. The pt sought unspecified medical attention. Follow-up from a registered nurse indicated that on 3/1/00, the pt's dermatitis and prostate conditions worsened and continued to worsened for 4-5 days, then improved slightly for approximately 1 month. The pt started a no yeast, no sugar diet and approximately 7 weeks post onset, the pt returned to prior vaccine status. The pt recovered 7 weeks post onset. Y Y 02/29/2000 03/01/2000 1 PUB PVT UNK dermatitis, allergy to PCN, prostate enlargement WAES00040319 1
0167475 03/15/2001 CA 18.0 18 F 03/07/2001 On 2/29/00 approximately ten hours post vax, the pt experienced an itchy urticarial rash over the arms, back, abdomen, hands, and legs. The pt visited the physicians office the next morning. Most of the itchiness had subsided. She was put on loratidine for four days. The rash resolved that day without any complications. She had no respiratory symptoms. No further information is available. Y Y 02/29/2000 02/29/2000 0 OTH OTH clindamycin acne WAES00040348 1
0167476 03/15/2001 WI 35.0 F 03/07/2001 Information has been received from an RN concerning a 35 year old Caucasian female who was vaccinated with the 2nd dose of Hep-B. Subsequently, the pt experienced redness and rash at the injection site. She was vaccinated with 3rd dose of Hep-B on 4/4/00. On approx. 4/5/00, the pt experienced erythema multiforme and a macula rash on the upper part of both thighs. She also experienced raised erythema around the injection site (about 8cm in diameter). The rash on the thighs only persisted for 24 hours. The injection site rash persisted for approx. 3 days. Medical attention was sought. She was treated with po Benadryl. The pt recovered on approx. 4/7/00. No further information is available. Y Y UNK UNK UNK UNK WAES00040461 1
0167477 03/15/2001 OH F 03/07/2001 Information has been received from an RN concerning a female pt who in 11/99 was vaccinated with a 2nd of Hep-B and subsequently, the pt experienced weakness at the injection site (left side). It was noted that the pt's symptom persists. Unspecified medical attention was sought. Additional information has been requested. Y N 11/01/1999 OTH OTH UNK UNK WAES00040475 1
0167478 03/15/2001 DE 15.0 15 M 03/07/2001 Information has been received from a NP concerning a 15 year old Caucasian male who on 4/5/00 was vaccinated IM with the 1st dose of Hep-B, a 2nd dose of MMRII SC. On 4/10/00, 60 hours, post vax, the pt experienced nausea, vomiting (2 X in the early morning) and stomach cramps. He vomited several times during the evening on 4/11/00. There was no known fever, diarrhea or unusual food. He "ate at McDonald's on 4/8/00; no unusual foods". Medical attention was sought. The pt recovered. He was normal by the time of exam on 4/14/00. No further information is available. Y Y 04/05/2000 04/10/2000 5 OTH OTH Allergy to PCN WAES00041407 1
0167479 03/15/2001 WI F 03/07/2001 Information has been received from a female RN who on 4/11/00 was inadvertently splashed on the side of the face with a small amount of Hep-B vaccine. It was noted that the vaccine did not enter the eye. Two days later, on approx. 4/13/00, the pt experienced redness and swelling of the site. It was noted that it appears to be cellulitis. The nurse completed the series with Hep-B vaccine and is immune. Unspecified medical attention was sought. Additional information has been requested. Y U 04/11/2000 04/13/2000 2 UNK UNK Claritin Latex allergy WAES00041569 1
0167480 03/15/2001 PA U 03/07/2001 Information has been received from an RN concerning an unidentified pt who was vaccinated with 4 doses of Hep-B vaccine and subsequently, the pt developed conjunctivitis, loose stools and a mild fever with achiness. The pt sought unspecified medical attention. Additional information has been requested. Y U OTH OTH UNK UNK WAES00041616 1
0167481 03/15/2001 PA 46.0 M 03/07/2001 Information has been received from a health care professional concerning a 46 year old male pt who was vaccinated with a 3rd dose of Hep-B vaccine. Subsequently, the pt experienced flu-like symptoms. Unspecified medical attention was sought. Additional information has been requested. Y U OTH OTH UNK Hepatitis C WAES00041643 1
0167482 03/15/2001 F 03/07/2001 Information has been received from a female pt who in 4/00 was vaccinated with the 1st dose of Hep-B vaccine, 6 weeks after giving birth. That same week, the pt started having hot flashes and experienced flushing, with a feeling of warmth radiating from the injection site down her arm. The pt sought medical attention. No further information is available. Y U 04/01/2000 04/01/2000 0 UNK UNK UNK Obstetrical procedure WAES00042331 1
0167483 03/15/2001 WI F 03/07/2001 Information has been received from a physician concerning a female long-term nursing facility pt who was vaccinated with the 1st dose of Hep-B vaccine and within a few minutes, post vax, the pt experienced dizziness and "syncope" which lasted for approx. 30 minutes. The pt sought unspecified medical attention. No further information is available. Y U UNK UNK UNK UNK WAES00042347 1
0167484 03/15/2001 VA 14.0 14 U 03/07/2001 Information has been received from a consumer concerning a 14 year old family member who on 4/21/00 was vaccinated with "the final dose" of Hep-B vaccine. "Soon afterwards, the pt experienced arm soreness "deep in the muscle" and twitching. The pt sought unspecified medical attention. Additional information has been requested. Y U 04/21/2000 04/21/2000 0 OTH OTH UNK UNK WAES00042481 1
0167485 03/15/2001 VA U 03/07/2001 Information has been received from a pt who in 2000 was vaccinated with Hep-B vaccine and subsequently, the pt experienced twitching in the legs. No further information is available. U UNK UNK UNK WAES00042485 1
0167487 03/15/2001 TX 28.0 28 F 03/07/2001 Information has been received from a PA concerning a 28 year old Caucasian female pt who on 4/26/00 was vaccinated with a 2nd dose of Hep-B and 30 minutes, post vax, the pt experienced redness and tenderness at the injection site, nausea, headaches, shakes and neck pain. The pt sought unspecified medical attention. The pt indicated that she had similar experiences following the 1st dose. Follow-up information from a physician's assistant, indicated that the pt was seen by a physician on 4/27/00 and subsequently, the pt recovered. Y Y 04/26/2000 04/26/2000 0 PVT OTH UNK Cesarean section; arrhythmia; knee surgery WAES00042804 1
0167488 03/15/2001 HI 40.0 M 03/07/2001 Information has been received from a physician concerning a 40 year old male who on 2/16/00 was vaccinated IM with the 1st dose of Hep-B vaccine. On 4/4/00, the pt experienced shingles along dermatome T1. He was treated with Keflex. No further information is available. Y U 02/16/2000 04/04/2000 48 OTH OTH UNK UNK WAES00042842 1
0167489 03/15/2001 VA 0.3 M 03/07/2001 Information has been received from an RN concerning a 4 month old male who was vaccinated at an unspecified date. Immediately, post vax, the pt developed pinpoint hives which came and went for about 30 minutes. The pt was treated with Benadryl. The pt was held in the office for 90 minutes, post vax. Additional information has been requested. Y U OTH OTH UNK WAES00050514 1
0167490 03/15/2001 IL 55.0 M 03/07/2001 Information has been received from a physician concerning a 55 year old white male who was vaccinated with a 1st and 2nd dose of Hep-B. After the 1st dose, the pt developed nausea, lethargy and weakness. After the 2nd dose, the pt experienced belly pain and developed dark urine. In approx. May, 2000, the pt had weight loss and still has abdominal pain. The pt sought medical attention. Follow-up information received on 7/12/00 from a physician indicated that after a complete work-up the signs and symptoms previously mentioned related to ETOH pancreatitis. Additional information has been requested. Y U CT Scan, upper and lower GI and an ultrasound-All wnl UNK UNK UNK UNK WAES00050571 1
0167491 03/15/2001 MD 27.0 27 F 03/07/2001 Information has been received from a health care professional concerning a 27 year old female who on 7/6/99 (lot 0162J) and 10/8/99 (lot 0570J) was vaccinated with the 1st and 2nd dose of Hep-B, respectively in the left deltoid. Subsequently, immediately after both vaccinations, the pt experienced warmth, light-headedness and extreme fatigue. She reported that she went to bed and slept through until the next morning. The pt also reported feeling cold at times. She sought unspecified medical attention. The symptoms resolved the next morning. It was noted that the because of the pt's reaction, the pt and her health care professional decided not to vaccinate with the 3rd dose. No further information is expected. Y Y 07/06/1999 07/06/1999 0 UNK UNK UNK UNK WAES00050585 1
0167492 03/15/2001 MD 38.0 38 F 03/07/2001 Information has been received from an RN concerning a 38 year old female pt who on 4/24/00 was vaccinated with a 1st dose of Hep-B, IM in the left deltoid. The same day, post vax, the pt experienced a sore arm, itching, a rash and felt "extremely fatigued". The pt saw a dermatologist. Follow-up information from an RN indicated that the dermatologist dx'd the pt with eczema. On 5/5/00, the pt recovered. Y Y 04/24/2000 04/24/2000 0 PVT PVT UNK NONE WAES00050687 1
0167493 03/15/2001 IN F 03/07/2001 Information has been received from a pharmacist concerning a female who on 4/11/00 was vaccinated with the 1st dose of Hep-B, IM. On 4/15/00, the pt developed erythema and experienced pain. The pt saw a physician who placed the pt on therapy with Medrol. The reporter stated that after completion of the dose pack, the pain returned and the pt is still experiencing pain. Follow-up information received on 8/8/00 from a pharmacist, indicated that on 4/25/00, the pt had developed pain, redness, swelling and a rash at the site. The pt received therapy with Medrol dose pack. On 5/5/00, the area was still painful and received treatment with therapy of naproxen. On an unspecified date, the pt recovered. No further information is expected. Y Y 04/11/2000 04/15/2000 4 PVT OTH UNK UNK WAES00050765 1
0167494 03/15/2001 CA 20.0 M 03/07/2001 Information has been received from an NP concerning a 20 year old male college student who in approx. 3/00 and 4/27/00 was vaccinated with the 1st and 2nd doses of Hep-B. The reported noted that the pt did not have any problems following the 1st vaccination. On 4/29/00, post vax of the 2nd dose, the pt became ill and developed intermittent fevers up to 103F, shivering, nausea and vomiting, and decreased urine output. On 5/2/00, the pt developed a decreased WBC of 4.3 which further decreased to 3.2 on 5/4/00 and a decreased platelet count of 132,000 which decreased further to 96,000 on 5/4/00. On 5/4/00, the pt was seen in the student health center by the NP and a physician and lab results indicated that the pt had hematuria. According to the reporter, the pt's physical exam on 5/4/00 revealed clear lungs, no costovertebral angle tenderness and a benign abdomen. The reporter indicated that the pt had blood cultures drawn and had a workup for hepatitis, both results are pending. The pt received hydration and was started on antibiotics. According to the reporter, the pt indicated that he has had "one sexual partner in his life and that person had not had any previous sexual partners". Additional information has been requested. Y U 04/27/2000 04/29/2000 2 UA-concentrated, amber urine, red blood cells without bacteria; CBC-WBC-decreased; platelet count-decreased OTH OTH UNK UNK WAES00050772 1
0167495 03/15/2001 MA 45.0 F 03/07/2001 Information has been received from an RN concerning a 45 year old female pt who was vaccinated with a 1st dose of Hep-B vaccine and subsequently, the pt developed "two very large blisters at the injection site. A heat pack was applied and the blisters grew to approx. half an inch high. One blister has broken". The pt sought unspecified medical attention. Follow-up information from a hospital, indicated that the reaction is now not considered a vaccine reaction. "The inquiry may have been a burn from using a hot pack on the injection site following pt complaint of site soreness." No additional information is expected. Y U OTH OTH UNK UNK WAES00050880 1
0167496 03/15/2001 CT 7.0 F 03/07/2001 Information has been received from a healthcare professional concerning a 7 year old female who on 5/9/00 was vaccinated with a 2nd dose of Hep-B. On 5/10/00, the pt developed hives, mild redness at the injection site and a cellulitis-type reaction. The pt remained afebrile. The pt sought unspecified medical treatment. Additional information has been requested. Y U 05/09/2000 05/10/2000 1 OTH OTH UNK UNK WAES00051272 1
0167497 03/15/2001 MI 25.0 19 F 03/07/2001 Information has been received from a physician concerning a 25 year old female pt who on 2/3/93, 3/10/93 and 9/10/93 was vaccinated IM with the 1st, 2nd and 3rd doses of Hep-B. The pt had a reactive anti-HBc in December and April, 2000. It was noted that the pt is asymptomatic. No further information is available. U 09/10/1993 12/01/1999 2273 12/99 and 4/00-anti-HBc positive UNK UNK Triphasil-28 NONE WAES00051398 1
0167498 03/15/2001 FL 51.0 F 03/07/2001 Information has been received from a woman from a physician's office concerning a 51 year old Caucasian female who on 11/1/99 was vaccinated with the 1st dose of Hep-B. On 11/24/99, the pt experienced a rash. She was seen by a physician. On 11/30/99, the pt was administered a 2nd dose of Hep-B and subsequently, she experienced systemic lupus erythematous. The 3rd dose will not be given. No further information is available. Y U 11/01/1999 11/24/1999 23 Serum hepatitis B-negative after 2 doses OTH OTH UNK UNK WAES00051404 1
0167499 03/15/2001 MD 8.0 8 M 03/07/2001 Information has been received from a physician concerning an 8 year old Caucasian male who on 5/10/00 was vaccinated IM with a 5th dose of Hep-B in the left deltoid. Subsequently, the pt developed a local reaction at the injection site on the left shoulder which involved a rash 7-9cm large with mild erythema, swelling but no tenderness or fever. The pt sought unspecified medical attention and was treated with Benadryl. On an unspecified date, the pt recovered. It was noted that the pt did not experience a reaction after the 1st dose. No further information is expected. Y Y 05/10/2000 UNK UNK Augmentin Sinusitis WAES00051414 1
0167500 03/15/2001 CA 10.0 10 M 03/07/2001 Information has been received from a public health nurse concerning an 11 year old Caucasian male who on 1/10/99 was vaccinated with the 2nd dose of Hep-B in the left deltoid. On 1/11/99, approx. 21 hours, post vax, the pt experienced hives on the upper torso, front and back. Subsequently, the pt recovered. No further information is available. Y 01/10/1999 01/11/1999 1 UNK UNK NONE UNK WAES00051473 1
0167501 03/15/2001 VA 0.3 M 03/07/2001 Information has been received concerning a 4 month old male who on 5/3/00 was vaccinated. On 5/3/00, 3 minutes, post vax, the pt developed small hives on his legs and lower trunk. The pt was treated with Benadryl and the hives resolved. It was noted that when the pt received the vaccines at 2 months of age, he did not have any reaction. No further information is available. Y 05/03/2000 05/03/2000 0 UNK UNK NONE WAES00051516 1
0167502 03/15/2001 WI 40.0 40 F 03/07/2001 Information has been received from a physician concerning a 41 year old Caucasian female who on 3/13/99 was vaccinated with 1 dose of Hep-B and subsequently, the pt developed intense swelling and arm numbness all the way down her arm. The pt sought unspecified medical treatment. It was noted that the pt's reaction lasted approx. 3 months. On an unspecified date, the pt recovered. No further information is available. Y 03/13/1999 OTH OTH UNK Allergies to codeine, cortisone, food, penicillin, pollen and shellfish. WAES00051553 1
0167503 03/15/2001 NY 11.0 11 M 03/07/2001 Information has been received from a physician concerning an 11 year old Caucasian male who on 5/1/00 was vaccinated IM with 1 dose of Hep-B vaccine. On 5/15/00, the pt experienced urticarial rash. A visit to a physician was required. Subsequently, the pt recovered. No further information is available. Y Y 05/01/2000 05/15/2000 14 UNK UNK UNK UNK WAES00051714 1
0167504 03/15/2001 IL F 03/07/2001 Information has been received from a pharmacist concerning an adult female who was vaccinated on an unspecified date with the 1st dose of Hep-B and within 4 hours, the pt experienced tightness in her throat and numbness up and down her arm. The pt went to a physician who dx'd the symptoms as viral pharyngitis. Addition information has been requested. Y U OTH OTH UNK UNK WAES00051851 1
0167505 03/15/2001 IN 23.0 F 03/07/2001 Information has been received from an RN concerning a 23 year old Caucasian female pt who in 1997 was vaccinated with a 2nd dose of Hep-B. One day, post vax, the pt's joints ached. Additionally, she experienced mild fever and nausea. The pt experienced no vomiting or diarrhea. Unspecified medical attention was sought. The symptoms resolved within 2 weeks. It was noted that the 1st dose of Hep-B was administered with no problem. Y Y NONE OTH PVT UNK Allergy to amoxicillin, erythromycin and penicillin. WAES00052216 1
0167506 03/15/2001 IL 0.2 M 03/07/2001 Information has been received from a woman in a medical center concerning a 2 month old male who on 3/9/00 was vaccinated and that same day, the pt became lethargic. Additional information has been requested. U 03/09/2000 03/09/2000 0 OTH OTH UNK WAES00052486 1
0167507 03/15/2001 CA 37.0 37 F 03/07/2001 Information has been received from a physician concerning a 37 year old Hispanic female nursing student who on 4/18/00 was vaccinated IM in the right deltoid with the 1st dose of Hep-B vaccine (1380J) and subsequently, the pt experienced severe malaise, red-warm injection site, pain and swelling at the injection site, fatigue, headache, nausea and chills and fever. The pt sought unspecified medical treatment. It was noted that the experiences lasted approx. 7 days and on an unspecified date, the pt recovered. No further information is expected. Y Y 04/18/2000 04/18/2000 0 Temperature-low grade OTH OTH UNK NONE WAES00052588 1
0167508 03/15/2001 AZ 0.4 U 03/07/2001 Information has been received from a physician concerning an infant less that 6 months old who was vaccinated and subsequently, the pt developed a transient rash. The pt sought unspecified medical attention. It was noted that the pt developed the rash after "multiple immunizations and the physician was not sure of which vaccines the pt received, however, he thinks it was possibly Hep-B and haemophilus B. Additional information has been requested. Y U OTH OTH UNK WAES00052762 1
0167509 03/15/2001 MO 24.0 23 F 03/07/2001 Information has been received from an RN concerning a 24 year old female who was a medical intern. On 12/15/97 lot 0876E, 4/1/98 lot 0876E and 4/2/99 lot 1896H, the pt was vaccinated with the 1st, 2nd and 3rd doses of Hep-B. On 5/31/00, the pt was dx'd with active Hep-B. The pt sought unspecified medical attention. The reporter stated a concern regarding the lot. Also reported was a male intern (WAES 00060272) who was vaccinated and developed a similar event. Additional information has been requested. Y U 04/02/1999 05/31/2000 425 UNK UNK UNK UNK WAES00060043 1
0167510 03/15/2001 MO 26.0 26 M 03/07/2001 Information has been received from an RN concerning a 27 year old male on 4/16/99 and 6/23/99 was vaccinated with the 1st (1896H) and 2nd (0285J) doses of Hep-B. Subsequently, the pt experienced active hepatitis B. Medical attention was sought. No further information was available. Y U 06/23/1999 OTH OTH UNK UNK WAES00080055 1
0167511 03/15/2001 UT U 03/07/2001 Information has been received from an RN concerning a pt who at an unspecified date was vaccinated with the 1st dose of Hep-B and subsequently, the pt experienced anxiety, restlessness, tightness of throat and a slight rash. The pt sought unspecified medical attention. Follow-up received on 8/2/00, stated that the pt had a lot of stress in her life. The pt called and went to see her physician and "her thyroid was low" so she was started on Synthroid. Following that visit, the pt became more anxious and the doctor dx'd hypothyroidism and anxiety. The pt went to the ER and had many subjective complaints but they were not seen by the doctors. The ER dx was hypothyroidism and possible increased thyroid. The pt went home and then "decided it was the Hep-B shot she had received days before". The pt called her doctor and was told to take a week off at work. The pt missed 7 working days of work. The reporter stated that "there were no objective findings to support any of the pt's complaints and she dx'd herself as a reaction to the Hep-B vaccine. The reporter also stated that "no doctor would say it was not or it was". The reporter stated that she thought it was an anxiety attack and the 1st and 2nd physicians were correct in their dx, however, physicians are not saying it wasn't the Hep-B vaccine. No further information is available. Y U EKG-neg; CBC-neg OTH OTH UNK UNK WAES00060250 1
0167512 03/15/2001 MO U 03/07/2001 Information has been received from an RN concerning a medical intern who was vaccinated with 1 dose of Hep-B. On an unspecified date, the pt was dx'd with active Hepatitis B. The pt sought unspecified medical attention. Also, reported was a female intern (WAES00060043) and 1 male intern (WAES00060055) who were vaccinated and developed a similar event. Additional information has been requested. Y U OTH OTH UNK UNK WAES00050272 1
0167513 03/15/2001 F 03/07/2001 In 1988, post vax, the pt experienced sickness. The pt felt that sickness was related to Hep-B vaccine. Her physicians told her the sickness was not related to Hep-B vaccine. No further information is available. Y U OTH OTH UNK UNK WAES00080310 1
0167514 03/15/2001 NY 14.0 M 03/07/2001 Information has been received from a physician concerning a 14 year old male who in April, 2000 was vaccinated with the 1st dose of Hep-B. In 2000, the pt experienced personality changes. The pt's personality changes persisted. No further information is available. Y N 04/01/2000 UNK UNK UNK UNK WAES00060348 1
0167515 03/15/2001 WA 46.0 46 M 03/07/2001 Information has been received from a physician concerning a 46 year old Black male who on 5/19/00 was vaccinated with the 1st dose of Hep-B lot 1240H, IM in the deltoid. Three days later or on 5/24/00, the pt developed an itchy rash on his hands and arms. The reporter indicated that the pt works outside. The pt sought medical attention from his physician. On an unspecified date, the pt recovered. It was also reported that on 6/27/00, the pt was vaccinated with the 2nd dose of Hep-B lot 1240M, IM in the deltoid. No reactions were noted. No further information is expected. Y Y 05/19/2000 05/22/2000 3 PVT PVT UNK UNK WAES00060355 1
0167516 03/15/2001 NJ 2.0 M 03/07/2001 Information has been received from a consumer concerning her 2 year old son who was vaccinated with the 3 dose series of Hep-B vaccine and subsequently, she sought unspecified medical attention and was found to have elevated liver function tests. Additional information has been requested. Y U Hepatic function tests-elevated liver function tests OTH OTH UNK UNK WAES00060358 1
0167517 03/15/2001 OH U 03/07/2001 Information has been received from a pharmacist concerning a pt who was vaccinated with 3 doses of Hep-B vaccine and subsequently, the pt had a positive hepatitis B surface antigen test. The pt sought unspecified medical treatment. Additional information has been requested. Y U Serum hepatitis B- (+) OTH OTH UNK UNK WAES00060449 1
0167518 03/15/2001 MN F 03/07/2001 Information has been received from a pharmacist concerning a female pt who was vaccinated IM with a 2nd dose of Hep-B and subsequently, the pt experienced a headache which lasted for 4 days. Unspecified medical attention was sought. Additional information has been requested. Y Y OTH OTH UNK UNK WAES00060484 1
0167519 03/15/2001 MD M 03/07/2001 Information has been received from a consumer concerning her son who on 10/1/98, 12/1/98 and 12/7/99 was vaccinated with the 1st, 2nd and 3rd doses of Hep-B. Subsequently, the pt developed flu-like symptoms after each vaccination which lasted for approx. 1 week. Additionally, it was noted that liver function tests were abnormal after each vaccination. In April 2000, liver function testing was noted to be 100 which was considered high. The pt sought unspecified medical treatment. Additional information has been requested. Y U 10/01/1998 10/98; 12/98; 12/99 and 4/00-(100) liver functions were all high OTH OTH Zyrtec; Levoxyl Allergy; thyroid dysfunction WAES00060652 1
0167520 03/15/2001 TX U 03/07/2001 Information has been received from a pharmacist concerning a pt who was vaccinated with a 3rd dose of Hep-B. One day, post vax, the pt developed a headache, fever, chills, back pain and drowsiness. The pt sought unspecified medical treatment. Additional information has been requested. Y U OTH OTH UNK UNK WAES00060872 1
0167521 03/15/2001 PA 17.0 F 03/07/2001 Information has been received from a physician concerning a 17 year old female pt who was vaccinated with a 1st and 2nd dose of Hep-B. Twenty-Three days, post vax, the pt developed herpes zoster in the distribution of the right C3 nerve. The 1st vaccination was administered in her right C2 dermatone. The herpes zoster resolved on it's own. Forty-two days, post vax of the 2nd dose, the pt developed herpes zoster in the C1 dermatone which was similar to the previous episode. The pt received no other medication and has no medical problem. No further information is available. Y OTH OTH NONE UNK WAES00061064 1
0167522 03/15/2001 NJ 25.0 F 03/07/2001 Information has been received from a NP concerning a 25 year old female pt who was vaccinated with a 1st and 2nd dose of Hep-B vaccine on 5/10/00 and 6/8/00. On 5/10/00, the pt's lab results indicated an increase in liver function (serum alanine aminotransferase test(177); serum aspartate aminotransferase test (196). On 6/8/00, the day of the pt's second dose of Hep-B vaccine, the pt's lab results indicated an increase in liver function (serum alanine aminotransferase test (133), serum aspartate aminotransferase test (215). It was noted that prior to the 1st dose of Hep-B, the pt experienced an increase in liver function (4-28-00); serum alanine aminotransferase test (122) and serum aspartate aminotransferase test (88). It was noted that on 5/17/00, the pt discontinued therapy with isoniazid and her serum aspartate aminotransferase test results decreased to 98. No further information is expected. Y U 05/10/2000 05/10/2000 0 serum alanine and serum aspartate-increased levels OTH OTH isoniazid PPD tuberculosis test (positive); hepatic function abnormality WAES00061069 1
0167523 03/15/2001 MI 44.0 44 F 03/07/2001 Information has been received from an RN concerning a 44 year old Caucasian female pt who on 3/23/00 was vaccinated IM in the right deltoid with a 1st dose of Hep-B. It was reported that the pt had "problems in spring and fall". On 3/24/00, at approx. 09:00, the pt experienced nausea and constipation. It was noted that the nausea was experienced "especially in AM". On 4/12/00, the pt recovered from her experiences. No further information is expected. Y 03/23/2000 03/24/2000 1 OTH OTH UNK NONE UNK WAES00061185 1
0167524 03/15/2001 TX 1.7 2 .5 F 03/07/2001 Information has been received from a physician's office concerning a 20 month old female pt who was vaccinate with a 2st, 2nd and 3rd dose of Hep-B vaccine. On 9/5/98, 10/6/98 and 03/10/99. It was noted that the pt received the Hep-B vaccine series because of family history of Hep-B. The pt had received a Hep-B immunoglobulin shot a birth. On 5/11/00, the pt had blood work done which indicated the pt contracted Hep-B. The pt sought unspecified medical attention. Additional information has been requested. Y U 03/10/1999 05/11/2000 428 Diagnostic lab on 5/11/00-Blood work was positive for Hepatitis B UNK UNK NONE NONE WAES00061254 1
0167525 03/15/2001 OH 74.0 F 03/07/2001 Information has been received from an RN concerning a 74 year old female dialysis pt who was inadvertently given Hep-B vaccine IV. Follow-up information from an RN reported that the pt developed a rash from the knees down. Unspecified medical attention was sought. It was noted in the chart on 7/21/00, but may have started before that day. The reporter noted that it appeared to be an allergic response, but that she could not attribute this to the vaccine because she is unclear of the sequence of events. Additional information had been requested. Y U 07/21/2000 OTH OTH UNK Hemodialysis WAES00061652 1
0167527 03/15/2001 MO 23.0 F 03/07/2001 Information has been received from a health care professional concerning a 23 year old female patient who on 06/02/00 was vaccinated with one dose of Hepatitis B vaccine recombinant. Subsequently, the patient experienced a rash described as "flesh-colored bumps" on her face, sides and legs. Unspecified medical attention was sought. Additional information has been requested. Y U 06/02/2000 UNK UNK UNK UNK WAES00051785 1
0167528 03/15/2001 TX 11.0 M 03/07/2001 Information has been received from a physician concerning an 11 year old male patient who on 06/13/00 was vaccinated with Hepatitis B vaccine recombinant. the following day, the patient developed a "punctate rash on his chest and upper back, a fever of 101.2F, general malaise, muscle aches, and nausea but no vomiting or diarrhea." The patient sought unspecified medical attention. Additional information has been requested. Y U 06/13/2000 06/13/2000 0 Body Temp 06/14/00 - 101.2. UNK UNK NONE UNK WAES00061786 1
0167529 03/15/2001 MA U 03/07/2001 Information has been received from a registered nurse concerning a patient who in approximately 1994 was vaccinated with Hepatitis B vaccine recombinant. Subsequent laboratory evaluation revealed positive Hepatitis B core antigen. Medical attention was sought. No further information is available. Y U Serum Hepatitis B Core - positive. UNK UNK UNK UNK WAES00062047 1
0167530 03/15/2001 TN 16.0 14 F 03/07/2001 Information has been received from a registered nurse concerning a 16 year old female who on 06/28/99 was vaccinated with a 2nd dose of Hepatitis B vaccine recombinant. She had been vaccinated with Hepatitis B vaccine (Engerix B) as the 1st and 3rd doses on 04/07/99 and 03/31/00. Subsequently, the patient experienced the inability to tan at the injection site on both the left and right arms in an area a quarter in size. Medical attention was sought. No further information is available. Y U 06/28/1999 OTH OTH UNK UNK WAES00062170 1
0167531 03/15/2001 MO 23.0 M 03/07/2001 Information has been received from a health care professional concerning a 23 year old male who was vaccinated with the 1st and 2nd dose of Hepatitis B vaccine recombinant. Subsequently, the patient developed swelling, pain, and a rash at the injection site. The rash was noted as being yellow and pus filled. The patient was noted as having this reaction after both shots, although "the second shot was a little less painful." The patient sought unspecified medical attention. Additional information has been requested. Y U UNK UNK UNK UNK WAES00063173 1
0167532 03/15/2001 DE M 03/07/2001 Information has been received from a registered nurse concerning a male patient who in approximately 2000 was vaccinated with the 1st and 2nd doses of Hepatitis B vaccine recombinant. Subsequently, the patient experienced numbness of the hands and feet. He was vaccinated with a third dose. Medical attention was sought. No further information is available. Y U UNK UNK UNK UNK WAES00063214 1
0167533 03/15/2001 MD 0.7 0 .7 F 03/07/2001 Information has been received from a physician concerning an 8 month old female who on 10/28/99 was vaccinated with a 3rd dose of Hepatitis B vaccine recombinant. On 10/28/99, the patient developed wheezing and a "croup-like" illness. Subsequently, the patient recovered. Additionally subsequent to this event. It was noted that the patient also experienced a similar reaction after vaccination with Varicella Virus vaccine live on 05/11/00. Additional information has been requested. Y 10/28/1999 10/28/1999 0 PVT PVT UNK UNK WAES00063265 1
0167534 03/15/2001 FL M 03/07/2001 Information has been received from a pharmacist concerning a male patient who was vaccinated with a 1st dose of Hepatitis B vaccine recombinant. Subsequently, the patient developed a rash that extended down his arm. Unspecified medical attention was sought. Additional information has been requested. Y U OTH OTH UNK UNK WAES00070225 1
0167535 03/15/2001 CA U 03/07/2001 Information has been received from a company representative concerning approximately one out of ten of a physician's southeast Asian patients who were vaccinated with Hepatitis B vaccine recombinant and Varicella Virus Vaccine Live concomitantly. The patients experienced a painful papular vesicular rash on the bottoms of their feet. The rash appeared in rings. Medical attention was sought. No further information is available. Y U OTH OTH UNK WAES00070357 1
0167536 03/15/2001 TX 11.0 M 03/07/2001 Information has been received from a company representative concerning an 11 year old male patient who was vaccinated with a dose of Hepatitis B vaccine recombinant. "Shortly" post vaccination, the patient experienced a 101 F fever and extreme fatigue. The patient sought unspecified medical attention. Additional information has been requested. Y U OTH OTH NONE NONE WAES00070645 1
0167537 03/15/2001 NY 21.0 M 03/07/2001 Information has been received from a licensed practical nurse concerning a 21 year old male patient who was inadvertently vaccinated with a 1st and 2nd dose of Hepatitis B vaccine recombinant in 1997 and in June of 1998, respectively. Subsequently, the patient's liver function tests were increased. The patient sought unspecified medical attention. Follow up information from a licensed practical nurse indicated that the patient had mononucleosis, which "explained his increased liver function tests. The patient was not admitted to the hospital. The patient is fine now." Y Y Hepatic Function Tests - increased. OTH OTH UNK UNK WAES00070726 1
0167538 03/15/2001 TX 1.75 0 .5 F 03/07/2001 Information has been received from a physician's office concerning a 21 month old Vietnemese female patient who on 03/10/99 was vaccinated with a 3rd dose of Hepatitis B vaccine recombinant. Concomitant vaccinations the same day included a 3rd dose of Haemophilus B conjugate vaccine, and a 3rd dose of Diphtheria Toxoid (+) Pertussis vaccine (+) Tetanus Toxoid. On 06/12/00, the patient's laboratory results were positive for Hepatitis B surface antigen. Additional information has been requested. Y U 03/10/1999 06/12/2000 460 Serum Hepatitis B 06/12/00 - Positive. UNK UNK NONE WAES00070901 1
0167540 03/15/2001 AZ 27.0 26 M 03/07/2001 Information has been received from a registered nurse concerning a 27 year old Caucasian Male patient who on 04/14/99 and 03/23/99 was vaccinated with a 1st dose of Hepatitis B recombinant. On 05/31/00 the patient sought unspecified medical attention and was diagnosed with Hepatitis B. His symptoms included right upper quadrant discomfort and fatigue. The patient was not jaundiced. The patient's "initial test" was positive for Hepatitis B and his 2nd test "didn't show any results to Hepatitis B". It was noted that a physician felt that the results of the 2nd test were "impossible to be right". The patient is "OK at present". The reporter expressed a concern with the lot. Follow up information from a registered nurse reported that as of 06/27/00 the patient is "OK" according to a physician. It was noted that it is unlikely that the patient received the 3rd dose of Hepatitis B vaccine Recombinant. On an unspecified date the patient recovered. Y Y 06/23/1999 05/31/2000 343 Initial test Hepatitis B - Positive. 2nd test - didn't show any results to Hepatitis B. UNK UNK UNK NONE WAES00071382 1
0167541 03/15/2001 RI 57.0 57 F 03/07/2001 Information has been received from a Physician concerning a 57 year old female patient who on 07/13/00 was vaccinated with a 1st dose of Hepatitis B recombinant. On 07/14/00, the patient developed floaters (dark dots) in the visual field. The patient sought unspecified medical attention. The reporting physician noted the patient now sees them more often> There is no pain or reduction in her vision and the physician "feels this is not optic neuritis." It was also reported that the patient experienced visual block spots and sparks (flash and lights). The patient was referred to an ophthalmologist. Follow up information received from a physician stated, "I have not seen the patient since my last report".It was noted that the patient's next appointment with this physician is in February, 2001. Additional information has been requested. Y U 07/13/2000 07/14/2000 1 PUB OTH Premarin, Synthroid. UNK WAES00071528 1
0167542 03/15/2001 TX 11.0 F 03/07/2001 Information has been received from an individual concerning an 11 year old female pt who on approx. 7/11/00, was vaccinated with a 1st dose of Hep-B and within 10 minutes, post vax, the pt fainted. It was noted that she was "completely out" and "at some point" woke up with a headache and red streaks on the base of her hands in between her fingers. Unspecified medical attention was sought. The pt subsequently recovered. Additional information has been requested. Y Y 07/11/2000 07/11/2000 0 OTH OTH UNK UNK WAES00071547 1
0167543 03/15/2001 DC 11.0 F 03/07/2001 Information has been received from an RN concerning an approx. 11 year old female pt who in approx. 1993 was vaccinated with a 1st dose of Hep-B and immediately, post vax, the pt developed a headache and raised red area at the site of the injection. The pt sought unspecified medical attention. It was reported that the pt never received the 2nd dose of the series. Additional information has been requested. Y U UNK UNK UNK Allergy to sulfa WAES00072095 1
0167544 03/15/2001 PA 17.0 17 F 03/07/2001 Information has been received from a physician concerning a 17 year old Caucasian female pt with idiopathic scoliosis who was vaccinated with a 1st and 2nd pediatric/adolescent dose of Hep-B on 5/24/00 and 6/27/00. Subsequently, following the 2nd dose the pt developed tremors of both hands. It was indicated that the 1st dose was administered with no problems. Conflicting follow-up from the physician indicated that the pt has been experiencing tremors since 7/5/00, after her 2nd Hep-B injection. However, on 7/3/00, the pt was seen in the scoliosis clinic by her pediatric orthopedic physician for her normal 6 mo. scoliosis checkup and the pt's mom indicated that the pt was having tremors in her hands. She was last seen in 10/98 and at that time her curves measured 25 degrees and 35 degrees. She is not having any problems. She has no pain with range of motion of her lumber spine with excellent range of motion of the spine. She has no pain with extension. She is having some lower back pain predominantly on the left side of her lower back in the region of her lumbar curve, most likely secondary to a fatigue type symptom. Her mom reported that she is having some tremors in her hands. An upper extremity neurologic exam was performed to evaluate her tremors and it was reported that her exam is entirely normal with full motor strength, sensation and reflexes. It was recommended that she come back in 6 mo. for follow-up care, repeat xrays and possibly consider MRI if there is progression of her scoliosis as well as to evaluate or rule out a spinal cord etiology of her tremors. On 7/6/00, the pt was seen by her family physician and it was reported that the tremors become worse when playing volleyball. The pt was referred to a neurologist for further evaluation. Follow-up information received from the neurologist's office on 10/24/00, indicated that the pt was scheduled for an appointment on 9/11/00 but "never showed up". No further information is expected. Y N 06/27/2000 07/03/2000 6 Repeat films today reveal a progression of her scoliosis. The curve from T5 to T11 is unchanged at 25 degrees. The lumbar curve from T11 to L3 measures 19 degrees. There has been a slight progression. Neurological exam on 7/3/00-normal. UNK UNK UNK Idiopathic scoliosis WAES00072277 1
0167545 03/15/2001 NE 18.0 F 03/07/2001 Information has been received from an RN concerning an 18 year old female who on an unspecified date the pt was vaccinated with a 1st dose Hep-B vaccine and on an unspecified date the pt was vaccinated with a 2nd dose of Hep-B (MSD). Within 1 day, post vax, of the 1st and 2nd vaccination administration, the pt developed severe nausea, vomiting, diarrhea and a headache. The reporter stated that the reaction lasted approx. 10 days. The pt sought unspecified medical attention. On 7/27/00, the pt was vaccinated with the 3rd dose of Hep-B. Additional information has been requested. Y Y OTH OTH NONE NONE WAES00072460 1
0167546 03/15/2001 AR 40.0 40 F 03/07/2001 Information has been received from an RN concerning a female pt who was vaccinated with a 1st dose and a 2nd dose of Hep-B vaccine, IM. Subsequently, after the 2nd dose, the pt developed a local hypersensitivity reaction with no fever. The pt sought unspecified medical attention. Additional information has been requested. The follow up info received from the pt, also a licensed practical nurse, she reported that on 07/21/2000, she had experienced soreness and pain, pruritis, erythema, ecchymosis, swelling, warmth, nodule formation, fatigue, weakness, migraine headache, pharyngitis, dizziness and diarrhea. The pt reported that she recovered about two weeks later on approx 08/04/2000. Follow-up info indicated that no medical attention was sought. No additional info is expected. Y 07/21/2000 07/21/2000 0 UNK OTH OTH UNK UNK WAES00080045 1
0167547 03/15/2001 KY M 03/07/2001 Information has been received from a consumer concerning her son who was vaccinated with Hep-B vaccine and subsequently, the pt experienced an adverse reaction (condition unspecified). It was reported that the pt's condition was resolving. Additional information has been requested. N OTH OTH UNK UNK WAES00080225 1
0167548 03/15/2001 TX 0.75 0 .8 M 03/07/2001 Information has been received from a physician concerning a 9 month old Caucasian male pt who on 2/21/00 was vaccinated in the right thigh with a 3rd dose of Hep-B. Subsequently, in 2/00, the pt developed a petechial rash. It was noted that the manufacturer of the 1st dose is unknown and the 2nd dose of Hep-B was Engerix-B. The pt had a similar experience following exposure to varicella virus vaccine live (WAES00072664). No further information is available. U 02/21/2000 UNK UNK UNK NONE WAES00080250 1
0167549 03/15/2001 MN 18.0 18 F 03/07/2001 Information has been received from an RN concerning an 18 year old Caucasian female pt who on 7/6/00 was vaccinated in the left deltoid with a 1st dose of Hep-B vaccine. Subsequently, on 7/8/00, the pt developed facial nerve tic with numbness. "The tic lasted for 1.5 days, no other adverse experiences occurred". Unspecified medical attention was sought. After 2 days, the pt recovered without treatment. Follow-up information from the RN indicated that the pt reported the symptoms started on 7/7/00 and were no painful. On 7/8/00, during the AM shift between 06:00 and 14:00, the pt presented to the office with symptoms of facial twitching which were present on the right side of her face. No muscle movement, other visible signs of muscle involvement, no facial drooping and no problems with verbal communication were noted. The physician's assistant on call was notified and instructions were given to observe the pt. If symptoms worsened, the pt was instructed to go to the ER. On 7/10/00, the pt was seen by the infectious disease nurse who reported that all symptoms of twitching had stopped and there was no need for the pt to be seen in the ER. The pt denies any problem with any other vaccines. No further information is expected. Y Y 07/06/2000 07/07/2000 1 OTH PVT UNK NONE WAES00080332 1
0167550 03/15/2001 MN F 03/07/2001 Information has been received concerning a female who was vaccinated with Hep-B and subsequently, the pt experienced arm hurting and arm feeling numb. The pt felt the arm hurting and feeling numb may be due to the severe arthritis. No further information is available. U OTH OTH UNK Severe arthritis WAES00080334 1
0167551 03/15/2001 OK 56.0 56 U Information has been received from a 56 year old female consumer who was inadvertently exposed through a needle scratch to her left thumb with improperly stored Hep-B vaccine. On 8/16/00, it was indicated that the pt accidentally scraped her left thumb with a syringe that was used to draw up the vaccine for disposal, while disposing of some improperly stored vaccines. It was a new sterile needle. A couple of minutes later, the pt's am started breaking out in a rash, that spread just above her elbow. It was "itchy, puffy, and kind of stingy". Additional information has been requested. U 08/16/2000 08/16/2000 0 OTH OTH Soma, Cataflam UNK WAES00081674 1
0167552 03/15/2001 PA 13.0 11 M 03/07/2001 Three days, post vax, the pt developed a fever, headache and ulcers in his mouth. The physician felt the pt's experiences were a viral reaction. The pt sought unspecified medical attention. The pt's parent told the nurse that she "heard that there was a new broadcast stating that there were cases of meningitis after RCV immunizations" (WAES00082197). The parents were quite concerned. On an unspecified date, the pt recovered. No further information is available. Y Y 08/07/2000 08/10/2000 3 OTH OTH NONE NONE WAES00081744 1
0167553 03/15/2001 SC 62.0 F 03/07/2001 Information has been received from a 63 year old female consumer who was vaccinated with a 1st and 2nd dose of Hep-B vaccine. It was reported that "after the 1st shot, she felt fine. Subsequently, after the 2nd shot, the pt started feeling different, discomfort and pain. She went on a trip to Asia after her 1st shot. On her way to China after the 2nd shot, she started feeling pain under her ear." It is unknown if medical attention was sought. She was scheduled to receive the 3rd dose of Hep-B in 11/00. Additional information had been requested. U UNK UNK antimicrobial UNK WAES00082013 1
0167554 03/15/2001 TX M 03/07/2001 Information has been received from an RN concerning a male who was vaccinated with Hep-B. Six weeks, post vax, the pt experienced loss of all of his hair. Medical attention was sought. Follow-up information from an RN indicated that "nothing happened to our pt". No further information is available. Y U OTH OTH UNK UNK WAES00082146 1
0167555 03/15/2001 IL 11.0 F 03/07/2001 Information has been received from an RN concerning an 11 year old female who was vaccinated with the 1st dose of Hep-B vaccine. Subsequently, the pt experienced hives. The reporter felt the hives were related to vaccination with Hep-B. Medical attention was sought. The reporter "was concerned that it may have happened with other children that got this lot". No further information is available. Y U UNK UNK NONE UNK WAES00082613 1
0167556 03/15/2001 VA F 03/07/2001 Information has been received from a health care facility concerning an unidentified female pt who was vaccinated with a 1st dose of Hep-B. Subsequently, the pt experienced "nausea, vomiting, and diarrhea which lasted 1 week." Unspecified medical attention was sought. Additional information has been requested. Y Y OTH OTH UNK UNK WAES00082694 1
0167557 03/15/2001 CO 22.0 F 03/07/2001 Information has been received from an RN concerning a 22 year old female pt who on 8/29/00 was vaccinated with a 1st dose of Hep-B and subsequently, 12 hours, post vax, the pt developed "hives at the injection site which spread to her whole body." The pt sought medical attention and was given Benadryl which helped to relieve the hives. Additional information has been requested. Y N 08/29/2000 08/29/2000 0 UNK UNK UNK UNK WAES00083049 1
0167558 03/15/2001 VA F 03/07/2001 Information has been received from a female RN who on an unspecified date was inadvertently splashed with Hep-B vaccine in her eye with administration of the vaccine. The pt sought medical attention. Additional information has been requested. Y U OTH OTH UNK UNK WAES00090249 1
0167559 03/15/2001 MN U 03/07/2001 Information has been received from a physician concerning an unidentified patient who was vaccinated with Hepatitis B vaccine recombinant. Subsequently two weeks after the patient was vaccinated, the patient experienced a "delayed reaction" described as "generalized hives". The patient sought unidentified medical attention. Additional information has been requested. Y U OTH OTH UNK UNK WAES00090378 1
0167560 03/15/2001 PA 0.25 F 03/07/2001 Information has been received from a consumer who is a registered nurse concerning her 3 month old granddaughter who at birth was vaccinated with a 1st dose and at one month of age with a 2nd dose of Hepatitis B recombinant. It was reported that after the 1st dose the patient developed a macular papular rash which developed into a vesicular rash. The rash is on the patient's trunk, scalp, and face. The rash seemed to be getting better until the 2nd dose of Hepatitis B vaccine recombinant was given along with other concomitant vaccines. The patient sought unspecified medical attention and the physician feels that the rash was eczema. No further info is available. Y N UNK UNK UNK UNK WAES00090495 1
0167561 03/15/2001 PA 18.0 18 M 03/07/2001 Information has been received from a registered nurse concerning an 18 year old Caucasian male patient who on 09/01/00 was vaccinated with a 1st dose of Hepatitis B vaccine recombinant. Ten minutes post-vaccination, the patient developed a painful upper arm and "severe cold sweats". It was noted that 10 minutes after the patient was vaccinated, he had to "pull over and get out of his car due to orange spots before his eyes. He laid down on the grass. The patient also complained of lethargy, muscle weakness, heart pounding, and feeling not with it. The patient recovered30 minutes post-onset. The patient denied rash, itching, shortness of breath, dyspnea, or fainting. Unspecified medical attention was sought. Y Y 09/01/2000 09/01/2000 0 PVT PVT NONE UNK WAES00090522 1
0167562 03/15/2001 NJ 41.0 41 F 03/07/2001 Information has been received from a health professional concerning a 41 year old Caucasian female patient who on 09/06/00 was vaccinated with a 2nd dose of Hepatitis B vaccine recombinant. Subsequently, the patient experienced a red, hot, swollen deltoid (injection site). The patient experienced injection site itching. There was no generalized symptoms. The patient took Ibuprofen and recovered by 09/09/00. Medical attention was sought. Additional information has been requested. Y Y 09/06/2000 09/07/2000 1 OTH PVT NONE Asthma WAES00090519 1
0167563 03/15/2001 PA M 03/07/2001 Information has been received from a pharmacist concerning an unidentified male patient who was vaccinated with Hepatitis B vaccine recombinant. Subsequently, the patient experienced elevated enzymes. The patient sought unspecified medical attention. Additional info has been requested. Y U Hepatic Function Tests - elevated. OTH OTH UNK UNK WAES00090623 1
0167564 03/15/2001 AL 15.0 15 M 03/07/2001 Information has been received from a licensed practical nurse concerning a 15 year old male patient who on 08/25/00 was vaccinated with a 1st dose of Hepatitis B vaccine recombinant. On 09/02/00, the patient developed generalized itching. On 09/04/00, the patient was seen by a physician and diagnosed with "acute contact dermatitis". Unspecified medical attention was sought. Follow up information from a licensed practical nurse indicated that the patient "complained of poison ivy" and was treated with "Mechal dose pak". Follow up information from a licensed practical nurse indicated that no additional info is available. Y U 08/25/2000 09/02/2000 8 PVT OTH UNK UNK WAES00090651 1
0167565 03/15/2001 CA M 03/07/2001 Information has been received from a company representative concerning a pediatric male patient who on an unspecified date was was vaccinated with the 1st dose of Hepatitis B vaccine recombinant. Within 15 minutes post-vaccination, the patient passed out and was sent to the hospital for testing. No abnormalities were found. It was noted that the patient is "fine" now. Additional info has been requested. Y Y Diagnostic lab tests - No abnormality OTH OTH UNK UNK WAES00090781 1
0167566 03/15/2001 CO 11.0 M 03/07/2001 Information has been received from a consumer concerning her 11 year old son who on 09/11/00 was vaccinated with one dose Hepatitis B vaccine recombinant. On 09/12/00, in the early AM, the patient developed a fever of 102 F, was very weak, and tired. The reporter indicated that as of 09/14/00 her son's fever had elevated again and he continued to feel very tired. Unspecified medical attention was sought. Additional info has been requested. Y N 09/11/2000 09/12/2000 1 OTH OTH UNK Asthma, Swelling. WAES00091167 1
0167567 03/15/2001 CA 11.0 11 M 03/07/2001 Information has been received from a physician concerning an 11 year old Hispanic male who on 9/1/00 was vaccinated with the 1st dose of Hep-B. Fifteen to twenty minutes, post vax, the pt fainted and fell straight back onto his head causing a contusion on the occipital region. He immediately, was awake and looked pale and frightened. The child was observed for 30 minutes then sent for a skull series. As per the mother, the skull series was within normal limits. On 9/1/00, the pt recovered. No further information is available. Y Y 09/01/2000 09/01/2000 0 Skull series-wnl PVT PVT NONE NONE WAES00091381 1
0167568 03/15/2001 TX 16.0 M 03/07/2001 Information has been received from a physician concerning a 16 year old male pt who on 9/12/00 was vaccinated with a dose of Hep-B and subsequently, on 9/13/00, the pt developed bilateral orchitis. The pt sought medical attention and no treatment was given; he was seen for observation only. Additional information has been requested. Y U 09/12/2000 09/13/2000 1 UNK UNK UNK UNK WAES00091461 1
0167569 03/15/2001 OH F 03/07/2001 Information has been received from a female physician who on 8/21/00 was vaccinated with Hep-B and on 8/25/00, the physician experienced injection site soreness and flu-like symptoms. On 9/9/00, she experienced a dermatologic reaction characterized by itching on her arms, legs, shoulder and waist. According to the physician, "it was similar to a herpes zoster because it was linear". She also stated that the "lesions were larger than poison ivy". The physician treated herself with hydrocortisone and Benadryl cream. At the time of the report, the rash persisted and she scheduled an appointment with a dermatologist. The outcome of the injection site soreness and flu-like symptoms was unknown. Additional information has been requested. Y N 08/21/2000 08/25/2000 4 UNK UNK UNK UNK WAES00091748 1
0167570 03/15/2001 NJ 6.0 M 03/07/2001 Information has been received from a consumer concerning his 6 year old Caucasian son who prior to 1999 was vaccinated with the 2nd and 3rd dose of Hep-B. It was noted that the pt received the 1st dose of Hep-B (Engerix-B) prior to 1999. For the past 3 years, the reporter noticed an auditory process problem. Six months ago, the child was dx'd with auditory process disorder from a child study group at school. The father wanted to know if prior to 1999, Hep-B had thimerosal as a preservative. The pt sought unspecified medical attention. Additional information has been requested. Y U OTH OTH UNK WAES00091856 1
0167571 03/15/2001 KS 18.0 18 F 03/07/2001 Information has been received from a health professional concerning an 18 year old female who on 9/21/00 was vaccinated with the 1st dose of Hep-B. On that same day, the pt experienced faintness, pallor and stiffness of the neck. The pt was put into bed, her blood pressure was monitored (BP-92/43, 20 minutes later BP-108/54) and orange juice was given for her to drink. By 16:45, the employee felt better. No further information is available. Y 09/21/2000 09/21/2000 0 BP PUB PVT UNK UNK WAES00092091 1
0167624 03/15/2001 NJ F 03/07/2001 Information has been received from a physician concerning a female who was vaccinated with Hepatitis B vaccine. Subsequently, the patient experienced pain at the injection site for 2.5 months and numbness at the injection site for 3 days after the injection. Additional information has been requested. Y U UNK UNK UNK WAES00092275 1
0167625 03/15/2001 IL 9.0 9 M 03/07/2001 Information has been received from a consumer concerning her 9 year old son (one of twins) who on 09/26/00, was vaccinated with Hepatitis B vaccine. On 09/27/00, the patient returned from swimming with a 10 cm x 4 cm bump going down his right arm where he was vaccinated. Unspecified medical attention was sought. Follow up info from a consumer indicated that her son was given "this shot series as a toddler". Conflicting follow up info from a member of the physician's staff indicated that on 08/31/00 the patient received his first dose of Hepatitis B vaccine. On 08/31/00, the patient developed a 2 inch red, warm, local reaction lasting 48 hours in the left arm. On 09/02/00 the patient recovered. No further details were provided. Y Y 08/31/2000 08/31/2000 0 UNK UNK NONE NONE ~Hep B (Recombivax HB)~~9.00~In Sibling WAES00092366 1
0167626 03/15/2001 IL 9.0 9 M 03/07/2001 Information has been received from a consumer concerning her 9 year old son (one of twins) who was vaccinated on 09/26/00, with one dose of Hepatitis B vaccine. On 09/27/00, when the patient returned from swimming his mother noted a 10 cm x 4 cm bump going down his left arm. Unspecified medical attention was sought. Follow up info from a consumer indicated that her son was given this "shot series as a toddler". Conflicting follow up info from a member of the physician's staff indicated that on 08/31/00, the patient was vaccinated with his 1st dose of Hepatitis B vaccine. On 08/31/00 the patient experienced a 3 inch red, raised, warm, local reaction at the site of the injection lasting 48 hours. The reporting healthcare provider indicated that the patient had recovered on 09/02/00. No further info is available. Y Y 08/31/2000 08/31/2000 0 NONE PVT PUB NONE NONE ~Hep B (Recombivax HB)~~9.00~In Sibling WAES00092367 1
0167627 03/15/2001 PA M 03/07/2001 Information has been received from adult male dentist who in approximately 1998 was vaccinated with Hepatitis B vaccine. Subsequently, the patient experienced flu-like symptoms. In 1998, the patient received a 2nd dose of Hepatitis B vaccine and reported that he was "wiped-out" one day post-vaccination. He stated that he spent the next day in the bed. Subsequently, the patient recovered. It was noted that he did not receive a 3rd dose. The reporter felt that his experiences were "definitely related to the vaccine". No further info is available. Y OTH OTH UNK UNK WAES00092442 1
0167628 03/15/2001 NJ 40.0 F 03/07/2001 Information has been received from a registered nurse concerning a female "in her forties", who in 1997, was vaccinated with the three dose series of Hepatitis B vaccine. In a recent blood bank screening, the patient developed positive surface antigens. The patient had a repeat Titer at her doctor's office on 09/28/00, results pending. Follow up information received on 10/19/00 from a registered nurse stated that the patient, who is a teacher, had lab work done by her own physician and it was within normal limits. No further information is expected. Y U Serum Hepatitis B 9/00 - Positive Serum Hepatitis B 09/28/00 - Wnl. UNK UNK UNK UNK WAES00100003 1
0167629 03/15/2001 GA F 03/07/2001 Information has been received from a pharmacist concerning a female patient who was vaccinated with a 2nd dose of Hepatitis B vaccine. Subsequently, the patient experienced flu-like symptoms. No further information is available. U OTH OTH UNK UNK WAES00100026 1
0167630 03/15/2001 GA 25.0 25 F 03/07/2001 Information has been received from a health professional concerning a white 25 year old female ophthalmic technician who was vaccinated with a second dose of Hepatitis B vaccine. Subsequently, the patient experienced nausea, vomiting, diarrhea, "possible" fever, and injection site pain and redness of the right arm. The patient told the health care professional "she was not sure if she picked up a flu, or if this was in response to the vaccination." Unspecified medical attention was sought. Upon follow-up the patient received from the health professional, the 2nd dose of hepatitis B vaccine was administered "midday" on 04/21/00 in the right deltoid. Later in the afternoon on 04/21/00, the patient experienced headache in addition to nausea, vomiting, diarrhea, "possible" fever, and injection site pain and redness of the right arm. The reporter indicated that the patient's experiences resolved on approximately 04/23/00. No additional information is expected. Y Y 04/21/2000 04/21/2000 0 PVT PVT UNK UNK WAES00100229 1
0167631 03/15/2001 MD M 03/07/2001 Information has been received from a physician concerning an unidentified male patient who was vaccinated with a dose of Hepatitis B vaccine. Subsequently, that same day he experienced muscle cramping, especially in his sides. Within a day he developed a pea sized nodule on his left arm biceps muscle A short time later he then noticed another nodule on his right elbow. He also complained of edema and ecchymosis on his arms. The physician confirmed some discoloration of the skin on the arms. A biopsy of the nodules was done by the physician and as of 10/04/00, results were still pending. Additional information has been requested. Y U Biopsy - Left arm nodule - results pending. Biopsy - right elbow nodule - results pending. OTH OTH NONE NONE WAES00100362 1
0167632 03/15/2001 VA M 03/07/2001 Information has been received from a doctor of pharmacy concerning a 3 day old male patient who on 09/08/00 was vaccinated with a 1st dose of Hepatitis B vaccine. Subsequently, the patient developed a temperature of 101.8 F. Unspecified medical attention was sought. Additional information has been requested. Y U 09/08/2000 10/08/2000 30 Body temp - 10/08/00 - 101.8 F OTH OTH UNK UNK WAES00100731 1
0167633 03/15/2001 ME 15.0 15 F 03/07/2001 Information has been received from a registered nurse concerning a 15 year old female who on 10/10/00, was inadvertently vaccinated with two doses of Hepatitis B vaccine. One dose of 10 mcq in the deltoid and one dose of 5 mcq in the deltoid. This was given as a first dose series by mistake. After the second injection, the patient fainted. On 10/10/00, the patient recovered. Y 10/10/2000 10/10/2000 0 UNK UNK UNK UNK WAES00100879 1
0167634 03/15/2001 OR 38.0 38 F 03/07/2001 Information has been received from a health professional concerning a 38 year old Caucasian female who on 09/13/00, was vaccinated with the 1st dose of Hepatitis B vaccine. On 09/13/00, the patient experienced arm pain. Follow up information indicated that when the patient was 18 she experienced "swelling" after a Tetanus booster. On 10/04/00 (previously reported as 10/13/00) the patient was vaccinated with her second dose of Hepatitis B vaccine, and experienced "immediate swelling-red, warm" and a hard knot that developed to the left side of the immunization shot site. Swelling spread about 1 inch with a knot. At the time of the initial report the upper arm was pretty swollen and ice was applied. The patient recovered within one week. No further information was available. Y Y 09/13/2000 09/13/2000 0 UNK UNK UNK Vaccine reaction. WAES00101226 1
0167635 03/15/2001 MI 19.0 19 F 03/07/2001 Information has been received from a registered nurse concerning a 19 year old female who on 10/10/00 was vaccinated with the 1st dose of Hepatitis B vaccine recombinant. Within five minutes post-vaccination, the patient passed out for about 10 seconds and was cold, clammy and very pale. The reporter stated that the patient's heart rate was 90 and her blood pressure went up to 140/100 for about 5 minutes and then returned to 130/86. The patient was given oxygen until she regained consciousness. The reporter stated that no other symptoms were noted. Additional info has been requested. Y Y 10/10/2000 10/10/2000 0 Blood Pressure 10/10/00 - 140/100, 130/86. Total Heartbeat Count 10/10/00 - Pulse 90. OTH OTH NONE UNK WAES00101299 1
0167636 03/15/2001 TX U 03/07/2001 Information has been received from a health professional concerning a patient who was vaccinated with a 2nd dose of Hepatitis B vaccine recombinant. One week post vaccination the patient "passed out". She was brought to the health professional via EMS and was noted to have high blood sugar level of 64, BP 80/50. Within 4-5 minutes the patient "woke up". It was noted that she had the same reaction following the 1st dose of Hepatitis B vaccine recombinant. No further info is available. Y U Blood Pressure - 80/50. Blood Glucose - 64. UNK UNK UNK UNK Syncope~Hep B (Recombivax HB)~1~0.00~In Patient WAES00101322 1
0167637 03/15/2001 CO F 03/07/2001 Information has been received from a physician concerning a female child who was vaccinated with a dose of Hepatitis B vaccine recombinant, who had a possible upper respiratory infection at the time of the vaccination. Subsequently, the patient developed urticaria. The patient sought unspecified medical attention. The physician did not feel that the reaction was caused by Hepatitis B vaccine recombinant. Follow up information from a physician indicated that the urticaria started hours after the injection of Hep B vaccine recombinant and "lasting for days". Subsequently, the patient recovered.. Y Y UNK UNK UNK URI WAES00101337 1
0167638 03/15/2001 CA 13.0 F 03/07/2001 Information has been received from a registered nurse concerning a 13 year old female patient who on 10/04/99, was vaccinated with a 2nd dose of Hepatitis B vaccine recombinant. A family member of the patient indicated that the following symptoms occurred "right after the vaccination: jaundice, dark circles under eyes, and pain in the ribs." These events were reported to the nurse at the patient's visit on 06/22/00. First the patient's family member stated the symptoms last 2 weeks and then then changed the length of time to one month. Additional information has been requested. Y Y 10/04/1999 10/04/1999 0 OTH OTH UNK Allergic to Ceclor. WAES00101753 1
0167639 03/15/2001 WA 14.0 13 M 03/07/2001 Information has been received from a registered nurse concerning an approximately 14 year old male patient who was vaccinated with a 1st and 2nd dose of Hepatitis B vaccine recombinant on 10/30/96 and 04/27/97, respectively. The patient's mother indicated that "he became very sensitive to the sun right after his 2nd dose. He developed a crusty ear lesion and a lesion on his finger in October of 1998. He got another sunburn of his face in May of 1999 that never went away. In August of 1999 by a dermatologist who made the diagnosis of discoid lupus. The nurse had no further information. Additional information has been requested. Y U 04/29/1997 OTH OTH UNK UNK WAES00101847 1
0167640 03/15/2001 NJ 30.0 F 03/07/2001 Information has been received from a registered nurse concerning a 30 year old female teacher who on 10/20/00 was vaccinated with a dose of Hepatitis B vaccine recombinant at 12:00 PM. It was noted that there were no illnesses at the time of the vaccination. One day post-vaccination, the patient developed "a 2" diameter injection site rash and a 1/8" nodule under the injection site, with itching". Unspecified medical attention was sought. Follow up info from a registered nurse indicated that on 10/21/00 at 13:00, the patient also experienced swelling, itching, and redness approximately 4 inches in diameter around the injection site. It was also noted that the number of prior doses equals 1. As of 10/24/00, the patient recovered from her experiences. Y Y 10/20/2000 10/21/2000 1 OTH PUB Ortho Tri-Cyclen UNK WAES00101970 1
0167641 03/15/2001 CO 0.5 F 03/07/2001 It was reported immediately post vaccine the pt presented with a gray, blue forehead which was above the orbits. The pt father felt the gray blue forehead was related to the vaccine. Y U 10/17/2000 10/17/2000 0 UNK UNK WAES00102095 1
0167642 03/15/2001 KY 43.0 F 03/07/2001 Information rec'd from a pharmacist reports post vaccine pt developed a rash that spread to the rest of her body. Y N 10/16/2000 10/19/2000 3 UNK UNK WAES00102184 1
0167643 03/15/2001 NJ F 03/07/2001 In 10/00, the pt experienced "redness and knot under the skin at the injection site". Unspecified medical attention was sought. No further information was available. Y U 10/18/2000 UNK UNK UNK UNK WAES00102208 1
0167644 03/15/2001 CA 12.0 F 03/07/2001 The pt was vaccination in 8/00. The pt experienced redness and mild swelling at the injection site on the left arm and fever of 102. Additional information has been requested. U 08/01/2000 temp - elevated OTH OTH UNK UNK WAES00102214 1
0167645 03/15/2001 OH 23.0 F 03/07/2001 With the third dose, the pt experienced pain and inflammation at the injection site. The pt's symptoms subsided. In follow-up the states the pt now has drug allergies she did not have prior. The pt reported that this event happened around 1990 when she was 23 years of age. The pt states that she recovered. No further information is expected. N UNK UNK UNK UNK WAES00110011 1
0167646 03/15/2001 CA 17.0 F 03/07/2001 The pt experienced hives following vaccination. Treated with Benadryl. The pt recovered. Additional information has been requested. Y UNK UNK UNK UNK WAES00110028 1
0167647 03/15/2001 VA 11.0 F 03/07/2001 Within a brief period, less than one hour, the pt experienced weakness, pallor, dizziness, nausea and had flushing of the face. The pts pulse was 76. Additional information has been requested. U UNK UNK UNK UNK WAES00110035 1
0167648 03/15/2001 CO 12.0 13 U On 8/4/98 the pt experienced nausea, aches and pains at the injection site in the right deltoid, redness at the injection in the right deltoid and flu-like symptoms. The pt recovered on 8/10/98. Additional information is not expected. Y 06/03/1998 06/04/1998 1 NONE UNK UNK seasonal allergies WAES00110145 1
0167649 03/15/2001 MA U 03/07/2001 The pt came close to passing out after getting the Hep B vaccine. The pt had breakfast that morning. Further information has been requested. U 11/02/2000 11/02/2000 0 UNK UNK UNK UNK WAES00110737 1
0167650 03/15/2001 NJ F 03/07/2001 Pt reports post vaccine she went to give blood and was told that she was borderline positive for Hep B surface antigen. U 02/29/2000 10/24/2000 238 UNK UNK WAES00110833 1
0167651 03/15/2001 MA F 03/07/2001 It was reported by nsg that pt post vaccine that the pt came close to passing out. Y U 11/02/2000 11/02/2000 0 UNK UNK WAES00110917 1
0167652 03/15/2001 FL 0.5 0 .5 F 03/07/2001 It was reported post vaccine's pt experienced fever on and off. Pt also experienced clear mucus from the nose, back pain, urinary symptoms, headache, constipation,skin rash, upper respiratory infection and malaise. The pt was treated with Tylenol and fluids. No further info is available. Y U 08/07/2000 08/14/2000 7 OTH OTH UNK WAES00111162 1
0167653 03/15/2001 CA M 03/07/2001 Information was reported from physician post vaccine pt's bilirubin level checked on was 3.1, on follow up it was 1.8. Physician's office did not feel the reaction was due to vaccine. Y 07/12/1999 10/22/2000 468 10/22/00 total serum bilirubin 3.1, 11/00 total serum bilirubin 1.8 UNK UNK Accutane WAES00111346 1
0167654 03/15/2001 ND 12.0 F 03/07/2001 Information was received from a pharmacist that pt post vaccine pt experienced local site reaction, generalized rash of injected arm and also opposite arm (site of previous vaccine). Follow up states on 11/18/2000 the patient recovered from the rash. Unspecified medical attention was sought. No further information is expected. Y Y 11/10/2000 UNK UNK WAES00111433 1
0167655 03/15/2001 MA 11.0 11 F 03/07/2001 It was reported post vaccine pt broke out in hives. In follow-up, the physician reported the pt had facial and stomach hives which started on 11/15/2000 at 9:30. The pt recovered from the facial and stomach hives. Unspecified medical attention was sought. Additiona info has been requested. Y Y 11/13/2000 11/13/2000 0 OTH PUB UNK UNK WAES00111876 1
0167656 03/15/2001 GA M 03/07/2001 Information was received from a pharmacist, post vaccine pt experienced back spasms, flu like symptoms and dark urine. Pt was examined in the ER and was confirmed hepatitis with liver function test and clinical examination. Y U hepatic function test/confirmed hepatitis. UNK UNK WAES00112106 1
0167657 03/15/2001 CA 38.0 F 03/07/2001 Information was received from a physician, pt post vaccine experienced dizziness, shortness of breath, nausea and fatigue. Y Y UNK UNK WAES00112143 1
0167658 03/15/2001 NJ 43.0 M 03/07/2001 Information received from a nurse reports the pt is a hemodialysis pt who did not seroconvert after the 3rd dose of hepatitis B, the pt experienced muscle soreness, he experienced shoulder pain that radiated down the R arm to hand and between his thumb and index finger. The area between this thumb and index finger appeared puffy, sometimes radiated into the opposite shoulder, also had neck pain. Y U serum hepatitis B/no seroconversion. UNK UNK hemodialysis WAES00112145 1
0167659 03/15/2001 KY 46.0 F 03/07/2001 It was reported that a pt allergic to yeast received hepatitis b vaccine recombinant (yeast), subsequently the pt had a reaction to the vaccine given a long time ago. Y U UNK UNK WAES00120020 1
0167660 03/15/2001 MD 22.0 22 F 03/07/2001 It was reported post vaccine's pt experienced tightness in the same area when she lays on that side (L arm)pt reports its not painful just tight. Y Y 10/27/2000 10/27/2000 0 UNK UNK WAES00120110 1
0167661 03/15/2001 NJ 37.0 37 F 03/07/2002 It was reported post vaccine pt experienced redness and knot under the skin at the injection site. The pt had no illness at the time of vaccination. On approx 10/24/2000, the pt's injection site became swollen, hot, red, and was very tender. The area was approx 3 inches in diameter. The pt had a knot under the skin at the injection site. Medical attention was sought. The nurse reported that "it appeared to be a grade 3 allergic reaction." The injection site remained tender and sore for several days. The nurse reported that the pt had not received the third dose of Hep B vaccine recombinant and probably would not. No further info was available. Y U 10/24/2000 10/24/2000 0 OTH OTH UNK NONE WAES00120187 1
0167662 03/15/2001 MO 40.0 F 03/07/2001 It was reported post vaccine pt developed vasculitis. Y U UNK UNK WAES00120253 1
0167663 03/15/2001 ME 15.0 15 F 03/07/2001 It was reported post vaccine pt was nauseous and vomited. Y Y 12/04/2000 12/04/2000 0 PVT UNK WAES00120474 1
0167664 03/15/2001 OH U 03/07/2001 A nurse reports post vaccine pt had severe pain and redness at injection site. In follow-up, the reporter stated that the pt's also experienced swelling at the injection site. No follow-up was required and the pt recovered. No further info is expected. Y NONE OTH OTH UNK NONE WAES00120498 1
0167665 03/15/2001 UT 42.0 42 F 03/07/2001 Pt complained post vaccine of joint pain, fever, swelling in calves and fingers and mild rash all over body. Y N 11/08/2000 11/15/2000 7 UNK UNK WAES00120516 1
0167666 03/15/2001 KY F 03/07/2001 Information received from a pharmacist pt in hospital in labor tested positive for hepatitis B surface antigen. Y U serum hepatitis B/ positive UNK UNK WAES00120594 1
0167667 03/15/2001 MN 1.0 U 03/07/2001 Physician reports post vaccine pt broke out in hives. Y N 12/07/2000 12/08/2000 1 UNK UNK WAES00120849 1
0167668 03/15/2001 NY 10.0 10 F 03/07/2001 Pt reports post vaccine she experienced throat soreness and hives that lasted for over 2 months. In follow-up, the pt's physician reported that the pt's mother thought there were an increase in allergic symptoms like rhinitis and urticaria. The pt recovered from the increase in allergy symptoms, allergic rhinitis, and urticaria. The pt's compplete blood count and serum immunoglobulin test was within normal limits. On 09/27/2000, the pt was vaccinated with the second dose of hep b vaccine IM. Unspecified medical attention was sought. No further info is expected. Y Y 11/08/1999 12/01/1999 23 CBC/within normal limits, serum immunoglobulin E/sed rate N1 PVT PVT Augmentin, Zithromax, Benadryl, Lorabid NONE WAES00121119 1
0167669 03/15/2001 PA M 03/07/2001 Information received from a nurse 2 months post hepatitis b series pt developed gastrointestinal problems such as abdominal cramping and intolerance. Was diagnosed with celiac disease. F/U no new info given. Y U UNK UNK WAES00121367 1
0167670 03/15/2001 AR 12.0 F 03/07/2001 Physician reports post vaccine pt developed a rash on her back that recurred from time to time over the last 5 months, subsequently the pt experienced fatigue. F/U no additional info was reported. Y U 12/28/1999 UNK UNK WAES00121600 1
0167671 03/15/2001 MN 14.0 14 M 03/07/2001 reports of pt post vaccine experienced very severe arthritis. Per mother all joints are stiff and painful. His L knee is huge, infusion fluid full. The pt's jaw, chest bone, wrist and shoulders were painful. He had muscle cramps.F/U update box 24, dob,date of vaccine,date of report. Y N 12/15/2000 12/17/2000 2 UNK UNK WAES00121993 1
0167672 03/15/2001 FL 22.0 22 F 03/07/2001 Information was received from a NP, post vaccine's pt developed and increased temperature and sore throat, runny nose, a rash that itched on her trunk and a few lesions on her arm. The pt did have some sinus congestion. F/U updated pt dob,date of vaccine, date of report,lot # for TD, pt name Y Y 12/05/2000 12/15/2000 10 UNK UNK WAES00122138 1
0167673 03/15/2001 OH F 03/07/2001 Information received from RN post vaccine pt experienced laryngitis. F/U update was box 24, pt name, date of vaccine, date of report. Y N 11/15/2000 12/13/2000 28 UNK UNK WAES00122208 1
0167674 03/15/2001 TX 19.0 19 F 03/07/2001 Information received from a RN, post vaccine the pt received a spot type band aid at the injection site. Three weeks to one month later the pt noted circular discoloration on the left arm that was described as a round light area with a darker center circle at the injection site. F/U updated box 24, pt name, dob, date of vaccine, date of report,adverse event onset 10/00. Y Y 09/29/2000 UNK UNK WAES00122218 1
0167676 03/15/2001 VA 50.0 50 F 03/07/2001 It was reported post 2nd vaccine pt experienced flu like symptoms, headachy,weak and left arm ached from the shoulder to hand. Y 08/16/2000 08/16/2000 0 UNK UNK WAES01010448 1
0167677 03/15/2001 OH 19.0 M 03/07/2001 Information was received from a pharmacist concerning pt who has an allergy to penicillin. Post vaccine pt experienced an injection site reaction. F/U rec'd updated box 24, pt name, dob,date of report, date of onset of adverse event 8/00, date of vaccine administered 8/00. Y Y UNK UNK Concurrent conditions: penicillin allergy WAES01010469 1
0167098 03/16/2001 FL 0.3 0 .4 M 03/15/2001 The pt died within 24 hours post vax. Time is unknown. Grandmother advised office staff of possible SIDS. Cause of death given as sudden infant death syndrome. Infant found unresponsive. Y 03/08/2001 N 03/07/2001 03/08/2001 1 PVT PVT NONE NONE NONE 1
0167107 03/16/2001 NY 1.75 1 .8 F 01/19/2001 On 11/27/00 the pt received Prevnar and on 12/21/00 she was diagnosed with Type 1 Diabetes. There is no family hx of diabetes. Y Y Y 2 Y N 11/29/2000 12/21/2000 22 blood glucose - 477 PVT PVT NONE NONE NONE 1
0167108 03/16/2001 PA 67.0 67 M 03/05/2001 This patient has fatigue, very swollen hands and wrists, rendering joints very painful and stiff, making the use of the hands almost impossible. 60 day follow up states the pt still has symptoms. Y Y N 04/14/1999 10/15/1999 184 Blood tests for rheumatoid arthritis showing extremely high RA Factor. PVT PVT NONE NONE NONE 1
0167109 03/16/2001 WI 49.0 49 F The pt had Lyme disease from 1987-1990. The Lyme vaccine has picked up where the Lymes left off, destroying my immune system, severely increase my neurological damage, causing pain to return and all other symptoms of Lyme disease. It has also messed with my mind and energy level so bad that I don't know if I can complete my rehabilitation schooling. 60 day follow-up states the pt experienced exhaustiion, pain, neurological damage, brain fog and lack of energy. Y N 05/04/1999 05/05/1999 1 lab tests - all neg PVT PVT Premarin, Mirapex (started after 1st vaccine). NONE NONE 1
0167110 03/16/2001 MS 5.0 5 F 02/23/2001 On 08/07/00, days after vaccinations, the patient began running a very high fever (105+). The fever finally was controlled on 08/10 or 08/11. On 08/12, she had a seizure. She was taken to the ER, placed on O2 and given Ativan; duration was about 45 minutes. This patient's history was totally remarkable prior to this event. She had tolerated all prior immunizations well, with no obvious reactions. After sleeping post-ictally for about 4 hours, she was transferred to a hospital. She was placed under the care of a pediatric neurologist. Her second seizure occurred almost exactly 24 hours after the first one; eight hours later she had a series of 3-4 seizures back to back. She was given a loading of Dilantin IV of that time and followed up with maintenance doses every 12 hours. She went another day with no seizures, but they began a three day span where she had 10-20 per day. Her liver was chewing up the Dilantin fast. Free levels would not remain in the therapeutic range. The third day, in the afternoon, she began having seizures in serial fashion. She was then transferred to the PICU and loaded with Phenobarbital, did stop the seizures, she stayed in the PICU for five days. Topomax was added to the AED regimen. She was moved back to the floor for five more days, then discharged home on those three meds. During the 1st three days in the hospital, they did a repeat spinal tap, MRI, and an EEG. The infectious disease unit also got involved in the CSF and blood tests, sending out for all sorts of tests. She had a repeat EEG in her room on Thursday (day 5) which captured an 8 minute seizure. Her seizures were classified as complex partial, secondarily generalized, multifocal. She lost consciousness, and did experience tonic-clonic convulsive movements that were observed on both sides; but not simultaneously. During the first several episodes, she also lost bladder control and one time she vomited. She also received Diastat on several occasions to stop the seizures. Sometimes she seemed to respond to it; sometimes not. It is now six and a half months later, she is on her fifth different AED combination, and the seizures remain uncontrolled. She has epilepsy. The 60 day follow up states intractable seizures; AED therapy ongoing but ineffective; surgical evaluation opinion is unanimous in opposition to surgery in the pt's case. Doc 211184 states that seizures have diminished in frequency from a peak of 45-50 per month during 6 months; of 2001 (march-august) to 15-20 per month from september to the present. Diagnosed with encephalopathy of unknown origin. Y Y 15 Y N 07/18/2000 08/12/2000 25 CT Scan, Labs, Spinal Tap, MRI, Chest X-ray- all Nml. EEG - capture the 8 min. seizure. OTH OTH #3: either lederle Lot # 466-925 or Aventis Lot # U0045BA. NONE NONE 1
0167111 03/16/2001 NY 21.0 20 F This patient had joint pain (extreme arthritis), headaches, tiredness; began over year after vaccine, no treatment possible. Y N 06/24/1999 08/18/2000 421 PVT OTH Ortho-Novum, multivitamins NONE NONE 1
0167113 03/16/2001 OH 1.26 1 .3 M 02/28/2001 This patient had a fever immediately following his vaccinations on 11/29/00; Tylenol was given. He started jerking rapidly, and forceably in his sleep, wasn't feeling well, not playful or his usual happy self. On Friday, 12/01/00 at 1 Am, the patient was swallowing hard, having "heaves", and then kept vomiting, fever was still present. 12/01/00, took the patient to the ER, they took his temp (99.1), checked his ears and throat. After 2 hours of waiting and being told they weren't going to see the doctor for at least another hour; the baby stopped vomiting, was hungry and tired so the mother got permission to go home from the nurse. The nurse commented that the patient looked "yellow" and asked if he ate carrots a lot, I stated with his baby foods. On 12/02/00, the patient was restless sleeping, rapid foreceable movements (jerking and jumping) in his sleep. The mother recorder a 1/2 hour of this and took the video tape with them to see the pediatric neurologist on 12/05/00. At the appt the mother explained the jerking to the doctor and that it seemed as if it was getting worse. The neurologist ordered an EEG, checked his injection site, saw no signs of infection. On 12/06/00, about 4 AM, the patient woke up crying, warm and wet the bed. The a mother changed him and put him to bed with her. Around 8:15 AM the patient was turned face down gasping for air, it seemed he could not pick up his head. The mother turned him over his eyes rolled up, lips were blue, and he was convulsing and drooling. She tried to clear his air passage then called 911, his breathing got better and seizures ceased by the time 911 arrived; who took him to the hospital, where they did some tests. The mother notified them of his recent vaccinations. After about 4 hours and against her and her husbands better judgement the doctors released with no antibiotics and a diagnosis of a virus. One of the nurses commented on the patient's "yellowish" appearance so the mother insisted on a bilirubin test. Since this was the 2nd time she heard this from a nurse. They took blood, check his vaccination sits, no apparent infection. The mother asked about the child's blood work before they left the hospital and the nurse said everything was just fine. Their only discharge instructions were to cycle the patient on Tylenol and Motrin. The mother notified the pediatric neurologist who scheduled an EEG for the next day 12/07/00. On 12/06/00, at 3 AM, the patient again had a high fever and jerking, the mother called the ER dept to speak with a nurse who advised a lot of liquid, after that the temp went down. On 12/07/00, The mother cancelled the EEG appt and took the child to the pediatric physician. The nurse took his vital, temp (down). The doctor commented on the patient's "yellowish" skin. The mother told the doctor the hospital they did test and a bilirubin test to check his liver and they told the mother everything was fine. The pediatrician said they did not do a bilirubin test and the blood test they did do show a skin contaminant, the urine test were Nml. The baby started to get tired so the mother held in her arms while the doctor went to check the patients bilirubin results; and the baby's head fell back, eyes rolled up, he was hot and seizing. The mother called out for help. The doctor came in the room with O2, rectal temp 101.3, and they called the ambulance and transported the patient and the mother to the hospital. Almost at the hospital when the baby let out a big cry/ gasp and started seizing, he was wearing an O2 mask and his face turned completely blue, his body turned red and hot. The EMT took the baby from the mother and began resuscitating him. As soon as they arrived to the hospital help came they "bagged" the baby for breathing until he stabilized (revived him). After they intubated and stabilized him the mother was allowed to see him. He was out on antibiotics and O2 and they did a spinal tap. The doctor said they would need to life flight the baby to another hospital due to the bad weather (snow) the patient and mom was taken by ambulance with an extra attendant in case the baby seized again. When they arrived to the Hospital the patient was given more Rocephin and Vancomycin, given an EEG and labs everything was Nml. The patient fever dropped after 2 days. He had a massive, explosive bowel movement, which broke his fever, so antibiotics evidently "killed" the virus "that no one could pin point where it came from. On 12/10/00 before discharge from the hospital the baby was feeling fine back to his normal self. A another doctor suggested that the antibiotics might be masking an infection of the bladder / kidneys, since the 1st urine at the ER was contaminated. The doctor suggested outpatient ultrasounds, and prescribed Cephalexin. The mother believes that the child's seizures on 12/6 and 12/7 were caused by a reaction to his MMR shot given on 11/29/00. She felt her son had been healthy since his first febrile seizure due to pneumonia in April of 2000. He had fevers, ear infections, colds, viruses, and fought them all off with and without antibiotics; without anymore seizures. As soon as he got his vaccinations on 11/29/00, he became sick, fever, vomiting, rapid forceful movements of jerking in his sleep, then the serious seizures. One thing the mother is certain of is that he was full of a virus / bacteria that no one can find an origin in his body or any existing infection present internally. His illness coincides with the adverse reactions date sheet symptoms. Y Y Y 4 Y 11/29/2000 12/01/2000 2 Spinal Tap, EEG, Ultra sound of the Kidneys, Lab work (bilirubin, urine catheterization). PVT PVT NONE Febrile seizure, pneumonia in 04/00. Torticollis of the neck. 1
0167193 03/16/2001 AZ 1.08 1 .1 M 02/27/2001 Urticarial rash locally to site adjacent to site of vaccine administration, not to vaccine site. Benadryl administered, infant playful. No further compromise. (MMR vaccine site). Y 02/27/2001 02/27/2001 0 NONE PVT PUB NONE NONE Microcephaly 1
0167194 03/16/2001 NH 4.0 4 F 03/12/2001 11cm X 10cm erythema; 4 1/2cm X 4cm induration on left arm. Y 03/10/2001 03/11/2001 1 NONE PVT PUB NONE NONE 1
0167195 03/16/2001 FL 1.0 1 .0 F 03/07/2001 Crying out in sleep, hallucinating, disorientation upon waking at office visit. Y Y 02/28/2001 03/03/2001 3 PVT PUB PPD/Parke/00540P/ID/LFA/0 previously NONE 1
0167196 03/16/2001 WA 1.0 1 .0 F 03/10/2001 Diarrhea, vomiting X 1 day, fever (100-102F) X 5 days. Y Y 02/27/2001 03/01/2001 2 FU: cultures were returned on 3/12/01 showed that child was infected with rotovirus. No treatment given as infection had almost run its course. OTH PUB NONE NONE NONE 1
0167197 03/16/2001 OH 0.3 0 .3 M 03/15/2001 Fever to 104F, 8 hours, post vax. Pt had fussiness and mother reports fever to 103F, immediately after as well as on 1/18/01. Y U 03/12/2001 03/12/2001 0 NONE PUB PUB NONE NONE NONE Reaction unevaluable~DTaP (no brand name)~1~0.20~In Patient 1
0167198 03/16/2001 WI 3.0 3 M 03/06/2001 Erythema, edema of left arm, elbow to shoulder. Child was irritable; unable to life arm; arm was swollen 2 X normal size by 20:00 on 3/3/01 at ER visit. Y Y 03/02/2001 03/03/2001 1 NONE PUB PUB NONE NONE NONE 1
0167199 03/16/2001 CA 1.25 1 .3 M 03/06/2001 Fever at bedtime 102F (R) on 2/6/01 and 2/7/01; 103F (R) on 2/8/01. Rash started on 2/7/01 and subsided on 2/11/01. Y 01/29/2001 02/06/2001 8 PVT UNK Amoxicillin started on 1/29/01 for ear infection. Ear infection NONE 1
0167200 03/16/2001 NY 4.0 4 U 1 day, post vax, pt had mild redness at site of right thigh; 3 days after vaccine pt had 9cm X 18cm redness and swelling, induration and warmth. No fever. Treated with Augmentin and resolved. Y Y 06/20/2000 06/21/2000 1 PVT PVT 1
0167201 03/16/2001 IL 3.0 4 F 03/05/2001 Reddened area, 2 days post vax, given in right deltoid. Area seen on 3/2/01 the size of 9cm X 10cm was reddened and warm to touch. Denies pain. Complains of being "itchy". Started Benadryl and Augmentin. Y 02/27/2001 03/01/2001 2 NONE PVT PVT 2/27/01 on Cefzil and Pan Mist for cold and OM Cold and OM NONE 1
0167202 03/16/2001 IL 1.2 0 .2 M 03/02/2001 Inconsolable crying for about 6 hours; started about 20 minutes, post vax. Child also refusing oral intake. Child examined in office and given PO Tylenol. Y Y 03/02/2001 03/02/2001 0 PVT PUB NONE NONE Likely benign PPS Heart murmur 1
0167203 03/16/2001 MI 1.5 1 .6 M 03/03/2001 Rash and fever with onset, 10 days, post vax of MMR. Y 02/20/2001 03/01/2001 9 PVT PVT NONE NONE Allergies to antihistamines and Zithromax 1
0167204 03/16/2001 1.25 1 .2 F 03/05/2001 Rashes to feet, hands, legs, neck and face. Trunk was clear. Diphenhist po X 72 hours. Onset of symptoms, 24 hours, post vax of Prevnar. Y Y 02/27/2001 02/28/2001 1 OTH PUB NONE NONE NONE 1
0167205 03/16/2001 5.0 4 F 03/05/2001 On 3/2/01, pt had pain, induration and erythema; no increased temperature. On 3/3/01, 70 X 110mm with induration and no increased temperature. Y 03/01/2001 03/02/2001 1 Physical exam OTH PUB NONE NONE Recurrent otitis media 1
0167206 03/16/2001 MD 0.2 0 .2 F 03/07/2001 Crying inconsolably from 13:00 to 19:00 (6 hours). Fed only 1 oz. Distraught and in pain at injection site. Short 5 minute naps with waking and shrieking. No fever. Y 02/07/2001 02/07/2001 0 NONE PVT OTH Reglan, Zantac NONE Shoulder dystocia, acid reflux, vomiting 1
0167207 03/16/2001 IL 2.0 1 .4 M 03/06/2001 Giant urticaria Y 03/03/2001 03/06/2001 3 PVT PVT Zithromax, completed 2 weeks ago NONE NONE 1
0167208 03/16/2001 OH 5.0 5 M 03/09/2001 On the afternoon, post vax, child had itching of leg at injection site. The following morning, he had redness that increased during the course of the day. Seen in office, that PM. Pt had area of erythematous (very small) around needle entry. Medially, he had an area about 2 1/2" X 1" irregular borders of erythema and increased warmth. Y 03/08/2001 03/08/2001 0 PVT PVT Augmentin Right otitis media Balanced translocation 13 & 14, (CHD, dislocated hip, cleft lip and palate, polycystic growth sac/sec deafness, increased BP, etc 1
0167209 03/16/2001 NC 1.0 1 .5 M 03/05/2001 Generalized maculo-papular rash. Treated with Benadryl for itching. Y 02/28/2001 03/02/2001 2 Rapid Strept-neg PVT PVT NONE NONE 1
0167216 03/16/2001 33.0 33 F 02/10/2001 Pt complained of headache, feeling ill and nausea, onset 1-2 hours, post vax. Had petechial rash at site of vaccine. Atraumatic injection. Treatment with Motrin and Benadryl. Y 02/02/2001 02/02/2001 0 MIL MIL Zoloft, Synthroid NONE NONE 1
0167219 03/16/2001 GA 41.0 41 F 02/22/2001 This patient's left arm (where the shot was given) broke out in a rash from her elbow to her shoulder. She took oral Benadryl and rubbed Cortisone cream on the rash to prevent itching. It went away in 2 1/2 days. Y 11/07/2000 11/08/2000 1 OTH PVT NONE Allergies to pollen 1
0167220 03/16/2001 MI 50.0 50 M 02/18/2001 My arm had a 3" X 2" swollen area around area where follow-up shot was given. It was warm and hurt to touch and it lasted for several days. Y 12/15/2000 12/16/2000 1 OTH PUB Verelan 1
0167221 03/16/2001 TX 58.0 57 F 03/06/2001 On 02/19/01 - This patient had Pneumovax and Flu vaccine given . On 02/20/01- She had a fever of 102, "feeling out of it", red local reaction at the injection site. On 02/21/01, more of the same very sick, rash on her arm 02/22/01 to sick to see a doctor. She went in to see the doctor on 02/23/01, severe rash, stared on Prednisone. On 02/24/01 reactions stopped , getting bigger. On 02/25/01 reaction much better, patient may stop medication. She wanted to keep taking the med. On 02/26/01, she saw the reactions again much better still recommend taking meds until Wednesday at least. Reaction at it's worse was red, itchy rash from shoulder to the elbow and half way around arm. Even blistered up with clear blisters. Later blood blisters evolved. As reaction started clearing up rash area turned yellow like bruising patient stated arm still stinging at the rash site. Y 02/19/2001 02/20/2001 1 OTH PVT 1
0167222 03/16/2001 NH 36.0 37 F 03/15/2001 Nausea, burning sensation "all over"; chest tightness but not short of breath, tingling "all over". Y 03/15/2001 03/15/2001 0 OTH OTH NONE NONE Nausea~Influenza (Seasonal) (no brand name)~1~34.00~In Patient 1
0167223 03/16/2001 CT 0.2 0 .2 M 03/05/2001 Immediately, during injection, baby was crying hysterically. When I picked him up he fell asleep instantly (a deep sleep). He would not awaken through walking to car and going into car seat (this is unusual for him). He slept on car ride and also when he was removed and still sleeping, placed on bed. I tried to wake him to breast feed as he was over due to eat. He would not wake up. I tried rousing him several times but I couldn't get him up until 19:00. This is not usual for him. Still refused to nurse. Finally at 19:30, he nursed but after that cried hysterically. Fell asleep again and slept several more hours. He woke at around midnight again. Next day was awake and alert as usual but had large red and swollen egg type lump at the injection sites. Both done next to each other, so don't know which caused the problem. Swelling lasted 4 days. Doctor said, before administrating it, that there are zero possible side effects so I didn't report them to her, immediately, as it would have fallen on deaf ears. Y 07/18/2000 07/18/2000 0 NONE PVT PVT NONE NONE NONE 1
0167224 03/16/2001 MO 0.08 0 .1 F 03/07/2001 Mom phoned and reports, infant daughter may have had a reaction to IZ. Possible seizure. No elevated temperature reported. Infant being assessed and tested for reaction. Prior to IZ, infant had to be hospitalized for Rotavirus. Awaiting further report from parent and physician. Y U 03/05/2001 03/07/2001 2 UNK UNK 1
0167225 03/16/2001 CA 5.0 5 F 03/09/2001 Pt developed fever of 103F (ear) at 03:00 on 3/7/01 and a large area of erythema on left deltoid. 3/7/01 at 14:00, entire outer deltoid affected. Rx'd Motrin for fever and soreness. U 03/06/2001 03/07/2001 1 NONE PVT PUB NONE NONE Questionable allergy to DPT. Reaction unevaluable~DTP (no brand name)~1~0.20~In Patient 1
0167226 03/16/2001 AZ F Fussy, crying, less active and possible early "fever". Documented 104F on 3/1/01 at 16:00. Y 02/28/2001 02/28/2001 0 CBC-NML PVT PVT NONE 1
0167227 03/16/2001 AZ 53.0 M 03/07/2001 This patient was on active duty to Guatemala 01/05/01 10 02/18/01. Started on Primaguine, Monday 02/19/01. On Tuesday, 02/20/01, the patient noticed redness to his hands. On Saturday 02/24/2001, a typical rash covering his entire body. Edema +3, to lower extremities. The patient was treated at a civilian ER on 02/25/01. Y Y 02/19/2001 UNK MIL Cardura, Atacand, Lopressor 1
0167228 03/16/2001 MD 28.0 28 F 03/09/2001 This patient received Tetanus Diphtheria 11:30 AM on 03/08/01. She took a nap, on awakening she noticed welts all over her body, that were itchy. Y 03/08/2001 03/08/2001 0 NONE PUB OTH Primetine Mist. NONE Bronchitis. 1
0167229 03/16/2001 NC 35.0 34 F 03/06/2001 On 03/05/01 at 10:00 AM, the patient called reporting a reaction to Tetanus vaccine given on 03/01/01 in the right arm. The area became red, swollen, warm to touch, the size of a baseball. Fever accompanied. She went to the urgent care center on 03/03/01. Placed on Keflex and Prednisone. Y Y 03/01/2001 03/03/2001 2 NONE PUB PUB NONE NONE NONE 1
0167230 03/16/2001 TX 4.0 1 .3 M 03/17/2001 Reported rash on back continues since bad hives during allergic reaction to DTAP/HIB. Rash worse with heat gets redder around perimeter. Y 03/08/1999 04/13/1999 36 Rash/hives PVT PVT 1
0167231 03/16/2001 IL M This patient had firm local swelling at the site of first injection, he felt to be local fatty necrosis. Larger firmer swelling after the second injection. Both areas remained swollen with some liquification of nodulm swelling and finally with local scarring at the site after several months of swelling. No treatment given. Y PVT PVT NONE NONE 1
0167232 03/16/2001 MN 1.0 1 .1 M 03/08/2001 Shortly after receiving shot, pt developed a blotchy rash to trunk and limbs. Dr notified. After 10-15 minutes, rash faded. Y Y 03/08/2001 03/08/2001 0 PUB PUB 1
0167233 03/16/2001 CT 10.0 10 M 03/07/2001 According to parent pt developed severe hives, vomiting, tired. Was treated with Benadryl. Reaction lasted approx 24hr. Y 03/01/2001 03/04/2001 3 PVT PVT 1
0167234 03/16/2001 IL 1.2 1 .0 F Two weeks after this patient had her MMR and Varicella vaccine she started breaking out in a "rash" which is getting worse on her shoulders and back. Has had no fever. She will see the MD in the AM. The doctor reported that he was "unsure"what it was. The mother reported it as "red with white, clear bumps" Hydrocortisone Cream was prescribed. Y U 01/22/2001 02/05/2001 14 PUB PUB NONE IL01004 1
0167160 03/19/2001 PA 1.25 1 .3 M 03/08/2001 Fever and diarrhea, lasting several hours. Treated with Tylenol, per recommended dose. Pt dx'd as being Autistic (2/6/01). Y N 07/19/2000 07/19/2000 0 PVT OTH NONE NONE 1
0167161 03/19/2001 AZ 1.0 1 .0 F 03/07/2001 Thrombocytopenic purpura; bruises, petechiae, increased tiredness, still ongoing. Admitted to the hospital, so far she has received 2 doses of Winrho, weekly CBC, platelet count has not recovered, currently ongoing. Per doc 212154, annual follow up, patient seems to be over any adverse event, but her pediatrician has said that she is already prepared to write a letter, because she will not administer the 2nd dose of MMR at age 4. Y Y 2 Y 12/28/2000 01/20/2001 23 Weekly CBC, platelet count (platelet counts as low as 2,000 and fluctuates from week to week). PVT OTH NONE Ear infection NONE 1
0167164 03/19/2001 NY 29.0 29 F 03/14/2001 This report is concerning a 29 year old female who on 2/13/01 was vaccinated with Hep-A and Japanese encephalitis vaccines. On 2/13/01, at 19:40, the pt complained of feeling hot, sweaty and slightly faint. The pt was placed in a supine position; BP was 134/70 and pulse was 94. The physician was notified immediately. At 19:41 the pt's BP was 131/70 and pulse was 70. The pt complained of tightness in the chest, very anxious and a funny feeling in he chest. Epinephrine was given IM at 19:45 and at 19:53 the pt stated she was not feeling good, Bp was 155/67 and pulse was 111. At 19:57, her BP was 163/75 and pulse was 101. The pt was still shaking. The pt had the following BP and pulse measurements: 163/75, pulse 117; 136/68 pulse 101; 149/67, pulse 113, 142/57. At 20:20, Benadryl was given IM with an immediate BP of 120/67 and pulse of 141. At 20:23, oxygen given 2L via nasal cannula. The pt's BP was 154/57 and pulse 127, 145/60 and pulse 119, 154/62 and pulse 129, 155/64 and pulse 131. The pt was transferred to the hospital. The pt reportedly recovered from the experience. This was originally reported by a health care professional. Additional information has been requested. Y Y Y 02/13/2001 02/13/2001 0 blood pressure - elevated, pulse - elevated UNK UNK UNK WAES01030834 1
0167166 03/19/2001 IL 15.0 15 M 03/14/2001 Information has been received from a registered nurse concerning a 15 year old male who on 08/23/00 was vaccinated with the first dose of Hepatitis B vaccine recombinant (yeast). On 09/25/00, the patient was vaccinated with the second dose of Hepatitis B vaccine. The 1s two injections of Hepatitis B vaccine were tolerated "without adverse effect". On 02/28/01, the patient was vaccinated with the third dose of Hepatitis B vaccine. On 03/01/01, the patient awoke with slight difficulty breathing and a feeling of a lump in his throat. The patient went to school, but later returned home feeling worse and was taken to the ER. The patient was treated with Benadryl and released. On 03/02/01, the patient experienced a swollen uvula and at the time of the report was continuing therapy with Benadryl. In a follow up, the nurse reported that "the patient is recovered." The nurse also reported that the patient's sister has had a "bad reaction" to the Pertussis vaccine but she said she did not know exactly what it was. However, she indicated that the patient has not had previous reactions to other vaccines and did not receive any other concomitant drugs or vaccines at the same time he received Hepatitis B vaccine recombinant (yeast). Upon internal review difficulty breathing, a feeling of a lump in his throat, a reaction to vaccine, and a swollen uvula were determined to Other Medical Events. Additional info has been requested . Follow up on 06/29/2001: "Lot # for vaccine 1 (1675K) is invalid." Y Y 02/28/2001 03/01/2001 1 UNK UNK UNK UNK ~Pertussis (no brand name)~~0.00~In Sibling WAES01030277 1
0167172 03/19/2001 CA 0.2 0 .2 F 03/08/2001 Approx. 2 weeks, post vax, pt had shaking of the left leg and right arm for about 20-30 seconds. Pt appeared to respond to mother during the episode of shaking. The arms and legs were not shaking simultaneously. Pt continued to eat well. Y 08/11/2000 08/24/2000 13 PVT PVT NONE NONE NONE 1
0167174 03/19/2001 ME 0.3 0 .3 M 03/07/2001 Mother reported on 12/7/00 by phone that pt's right leg was swollen. On the next well child exam on 2/7/01, mother reported that right leg was quite swollen for 3 days. Y 12/05/2000 12/05/2000 0 NONE PVT UNK NONE NONE 1
0167175 03/19/2001 NH 1.5 1 .5 M 03/12/2001 Pt had fever of 103F and rapid breathing. Y Y 03/08/2001 03/08/2001 0 PVT PUB NONE Ear pain ? NONE 1
0167176 03/19/2001 CA 1.5 1 .6 F 02/26/2001 Father called H C to report that child developed a rash on stomach and back area, 6 days, post vax. Child was fussy, clingy and had loose stools X 2 days; onset on 2/24/01. U 02/20/2001 02/26/2001 6 NONE PUB PUB NONE NONE NONE CA010019 1
0167177 03/19/2001 PA 1.25 1 .3 F 03/12/2001 Pneumonia and progressive respiratory distress and bronchospasm with subsequent myocardial depression requiring intubation X2 days and IV pressors (dopamine and dobutamine). Y 9 Y 02/12/2001 02/14/2001 2 CXR and Echo done PVT PVT NONE NONE Reactive airway disease/asthma 1
0167178 03/19/2001 NY 1.25 5 F 03/16/2001 Pt had fever of 104F, approx. 3-4 hours, post vax, lasting 2 days, brought down by Tylenol and 2nd day had syncope vs seizure activity as described by parents. Y 03/12/2001 03/12/2001 0 PVT UNK NONE NONE 1
0167179 03/19/2001 NC 2.0 1 1 F 03/09/2001 Erythema and induration at injection site 11 1/2cm X 6 1/2cm. Y 03/05/2001 03/07/2001 2 PVT PUB Croupy cough-viral NC01030 1
0167210 03/19/2001 CA 20.0 20 M 03/12/2001 From an initial report received on 1/4/01, it was reported that a 20 year old male was given Menomune A/C/Y/W-115 vaccine on 5/4/00. Pt reportedly experienced "loss of consciousness at 19:20 X 6 seconds; mild tonic/clonic activity in arms and legs". BP 130/70; AP 44. From additional correspondence received on 3/6/01, it was reported "I have reviewed the completed VAERS form for completeness and accuracy. If you have any questions or require any additional information please call." Y 05/04/2000 05/04/2000 0 OTH OTH NONE NONE hx of syncope with other injections U2001003510 1
0167211 03/19/2001 MD 0.4 0 .4 F 03/13/2001 One day post vax, the pt developed generalized swelling over her body. She was seen in an ER and treated with epinephrine and Benadryl. The infant recovered. This is considered "medically important". F/U info rec'd from the physician on 4/5/01 indicated that the infant developed diarrhea on the night of vaccine. Informaton regarding Prevnar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a pediatrician regarding a 5-month old female who experienced generalized swelling, diarrhea and hives. At 5 months of age, the infant received the second dose on 14-Feb-2001. On 2/17/01 she developed generalized swelling over her body (swelling) and hives (urticaria). The infant was seen in an emergency room and treated with epinephrine and Benadryl (diphenhydramine). The infant recovered. The pediatrician indicated that the infant has received one additional "booster" with no side effects. (OMIC) Y Y 02/14/2001 02/14/2001 0 UNK PVT OTH NONE UNK Medical history: The infant's medical history included multiple drug allergies. HQ8216309MAR2001 1
0167235 03/19/2001 CO 2.0 2 .3 F 03/12/2001 Measles, rash, fever, rhinitis,Koplik's spots. U 02/26/2001 03/07/2001 9 PVT PVT 1
0167236 03/19/2001 MT 0.7 0 .7 M 03/12/2001 2 days post vaccine pt developed rash to cheeks, trunk and back of head, swollen glands to back of neck. Rash persists to cheeks and trunk. Y Y 01/31/2001 02/02/2001 2 PUB UNK 1
0167237 03/19/2001 AL 8.0 8 M 03/07/2001 Post vaccine pt's arm became pruritic, began to swell, turn red and became tender. 03/05/2001 03/06/2001 1 PUB PUB Zyrtec Allergy to grass, weed, tree, pollens, CP;seizure disorder. 1
0167238 03/19/2001 NH 41.0 4 M 03/09/2001 Reports of significant swelling, erythema L Upper arm, site of injection. Y 03/07/2001 03/08/2001 1 PVT UNK 1
0167239 03/19/2001 CA 13.0 13 F 02/26/2001 Pt felt like she was going to pass out post 2 vaccines. Mom brought pt back to exam room and pt passed out, fell off exam table and hit pubic area. Pt was diaphoretic, clammy and c/o of headache, vital signs taken, pt stabilized. Y Y 02/26/2001 02/26/2001 0 OTH OTH 1
0167240 03/19/2001 CA 28.0 28 M 02/23/2001 Pt reports post vaccine he saw red spots around injection site. Pt was treated with Benadryl, epinephrine, treated with Epi, Benadryl and O2. Released home after 1 hr. Y Y 02/23/2001 02/23/2001 0 PUB PUB CA010017 1
0167241 03/19/2001 HI 40.0 4 F 03/08/2001 Pt reports post vaccine fever, swelling (local), redness, induration to lat deltoid, tender nodes. Diagnosed with Serum Sickness Syndrome. Y Y 03/03/2001 03/04/2001 1 UNK UNK 1
0167242 03/19/2001 MN 44.0 44 F 03/09/2001 Pt reports post vaccine N/V, dizziness, muscle pain in neck,shoulders, arms, legs, weakness of extremities. Small area of fine rash on chest. Y Y 02/28/2001 03/01/2001 1 PVT PVT Effexor, Treazdons 1
0167243 03/19/2001 CA 44.0 44 F 03/02/2001 Pt reports he developed red,hot,swollen patch 6x8cm in size, tender to touch, soreness. Pt felt feverish. Y Y 02/28/2001 03/01/2001 1 OTH PUB PPD/Parkdale Pharm/lot#01430P/left Arm. Hctz HTN, URI HTN CA010018 1
0167244 03/19/2001 IL 67.0 67 M 03/14/2001 Pt reports post vaccine red area deltoid, warm to touch, erythema a area 3" diameter to Rt deltoid. Treated with steroids. Y 03/08/2001 03/09/2001 1 PVT PVT COPD, hyperlipedemia 1
0167245 03/19/2001 WA 1.25 1 .4 M 03/09/2001 Reported pt had red, swollen and hot right upper arm, no fever. Y U 03/07/2001 03/07/2001 0 PVT PUB 1
0167246 03/19/2001 FL 39.0 40 F 03/16/2001 Pt reports post vaccine she developed rash and arthralgia of fingers. By 3/16 rash had resolved but arthralgia has increased. N 03/12/2001 03/14/2001 2 PUB UNK iodine 1
0167247 03/19/2001 MD 5.0 1 .1 M 03/12/2001 Child presents with chicken pox at various stages, papular, crusted scabbed and resolved. Mild case. Y Y 02/24/1997 03/10/2001 1475 PVT PUB resolving ROM 1
0167248 03/19/2001 LA 4.0 1 .7 M 03/12/2001 Severe outbreak of chickenpox. Y 08/26/1998 03/06/2001 923 PVT PUB 1
0167249 03/19/2001 CA 39.0 39 F 03/05/2001 Pt reports itching injection site,pain to touch, 3cm soft swelling, 3cm red, tender,mild flu. Y 03/02/2001 03/04/2001 2 PVT PVT back and shoulder strain NSAIDS allergies 1
0167250 03/19/2001 NJ 3.0 0 .4 F 03/13/2001 Reported high pitched shrill screaming for about 2 hrs, vomiting,glassy eyed and went limp, swollen at injection site(red & swelling of leg), drenched full of sweat in middle of the night, temp of almost 103F. Y 12/08/1997 12/08/1997 0 PVT OTH 1
0167251 03/19/2001 NC 21.0 21 F 03/09/2001 Post vaccine pt developed a fine erythematous,military type rash over both arms and legs. The rash was pruritic. Y 03/05/2001 03/07/2001 2 MIL MIL Allergy to Sulfa drugs. 1
0167252 03/19/2001 GA 1.3 1 .3 M 03/09/2001 Mother reports post vaccine pt arm was swollen and leg swollen and warm to touch. Fever of 101F. U 03/08/2001 03/09/2001 1 PUB PUB 1
0167253 03/19/2001 MO 27.0 27 M 03/13/2001 Pt reports rash over forehead and chest following fever and muscle aches. Y 03/01/2001 03/10/2001 9 PVT PVT PCN allergy 1
0167254 03/19/2001 CA 55.0 55 F 03/09/2001 Pt developed 3" erythema around injection site, nausea, headache, and small red rash around injection site. Y U 03/01/2001 03/03/2001 2 CBC, CMP,UA/normal studies PVT PVT Same reaction~Hep A (no brand name)~3~44.00~In Patient 1
0167255 03/19/2001 ND 7.0 7 M 03/01/2001 7 1/2 hrs post vaccine pt developed hives on body, vomiting,difficulty swallowing. ER visit times 2, treated with Benadryl. Y Y 02/28/2001 02/28/2001 0 PUB PUB pepcid, cortisone 1
0167256 03/19/2001 WI 1.0 1 .1 F 03/14/2001 Pt developed a red indurated area at the site of injection and rash all over body 48 hrs post vaccine. Y 12/18/2000 12/20/2000 2 PVT PVT 1
0167257 03/19/2001 PA 4.0 4 M 03/15/2001 1-2 days post vaccine developed mild local redness, swelling. Suspect secondary cellulitis to needle punch, vaccine itself. Y Y 03/07/2001 03/08/2001 1 PVT PVT 1
0167258 03/19/2001 UT 96.0 96 F 03/15/2001 Pt developed redness at injection site, spreading from site down to elbow. 02/26/2001 02/28/2001 2 PVT OTH B12/IM/RD Hypertension, confusion 1
0167259 03/19/2001 MD 20.0 20 F 03/16/2001 Pt states developed fever, extreme weakness, pallor times one day. Did not seek treatment. Y 12/06/2000 12/07/2000 1 PUB PUB Depo Provera Allergy: Codine, Darvon, Tylox, Darvocet 1
0167374 03/20/2001 CA 0.3 0 .4 M 01/14/2000 It was reported that a 4 month old male patient received Tripedia, ActHIB and IPOL vaccination on 01/11/00. Reportedly within 48 hours after his vaccination the patient developed twitching of the head, neck, and right arm. The patient was seen by a pediatrician and admitted to the hospital on 01/14/00, by a neurologist for possible seizure disorder. Y Y U 01/11/2000 01/13/2000 2 UNK UNK U2000000170 1
0167375 03/20/2001 FL 0.2 M 06/28/2000 It was reported that a 2 month old male received a Tripedia, Hep-B, Hib and a Polio vaccination. Reportedly, sometime after the vaccinations, the pt developed a fever of 103F. Unable to determine source of fever, the pt was hospitalized for fever management. Further information requested. Y U UNK UNK U2000005180 1
0167376 03/20/2001 VA 1.25 1 .3 F 03/15/2001 Pt was seen for a well 15 month checkup on 2/20/01. She had mild wheezing and was afebrile. She was given MMR, Varivax and Prevnar #2. She was treated with albuterol syrup and Zithromax. She had a cardiopulmonary arrest on 2/23/01. Is there a correlation between mild wheezing, any of the vaccines, the medications used and sudden death? Pt had unexplained cardiopulmonary arrest and expired. Autopsy also states bruise right side of forehead, congestion, pulmonary edema. Cause of death given as acute bronchitis. Y 02/23/2001 N 02/20/2001 02/23/2001 3 UNK UNK Albuterol, Zithromax. 1
0167378 03/20/2001 CA 1.5 1 .6 M 03/19/2001 The pt experienced irritability, followed by regression of language and social behaviors, constant diarrhea and rash on cheeks. The pt also experienced a lack of eye contact, resistance to being touched or held and high-pitched screaming. The pt was diagnosed with autism on 9/26/96 and on 10/97 with celiac disease. 60 day follow up states the pt has gastrointestinal damage and neurological damage. Y N 01/19/1996 02/02/1996 14 PVT PVT NONE NONE NONE 1
0167379 03/20/2001 NH 0.3 0 .3 F 02/12/2001 Within 12 hours the pt experienced 5 seizures. The 1st two were blank stares lasting 10-20 seconds. The 3rd and 4th, the pt stopped breathing for 20 seconds. the 4th and 5th ones she became stiff and shook. She got worst with a rash and the last one was the longest lasting 1 minute and 15 seconds. They gave her Phenobarbital for her seizures. FU info states child was premedicated with Tylenol for the vaxs. Y Y 2 Y 01/12/2001 01/28/2001 16 Spinal Tap-neg; CXR-normal; lab work-neg; Urine-nml; Cat Scan-nml; EEG-nml; MRI-nml PVT OTH NONE NONE NONE 1
0167380 03/20/2001 RI 68.0 68 M 03/13/2001 On 12/8/00, pt had clumsiness; dropping tools. On 12/9/00, had difficulty with balance and swallowing. On 12/10/00, could not move without assistance and had slurred speech. "Miller-Fisher variant of Guillain-Barre". Still hospitalization. 60 day follow-up states the pt was discharged from the hospital on 5/7/01. Y Y Y 12/07/2000 12/08/2000 1 PVT PVT NONE NONE 1
0167381 03/20/2001 NC 3.0 2 .9 M 03/15/2001 The pt developed cellulitis requiring hospitalization and IV antibiotics. Y 1 Y 03/09/2001 03/09/2001 0 CBC; Sed Rate-WNL PUB PUB NONE upper airway obstruction, otitis media 1
0167384 03/20/2001 MA 4.0 4 M 03/15/2001 The pt developed a seizure at home on 3/15/01 early in the morning. EMT called, taken to the hospital. The pt experienced another episodes of seizures, was intubated, started on Dilantin IV and transferred to another facility. Y Y Y 03/14/2001 03/15/2001 1 CT of head-possible small old infarction; LP-elevated opening pressure PUB PUB Albuterol, Singulair 1
0167385 03/20/2001 FL 14.0 F 03/12/2001 It was reported that a 14 year old female patient received an unknown form of BCG (either vaccination or for bladder cancer) deep intramuscularly, as a result of medication error, approximately one year ago. The original order was for "tetanus TD". About one month after the injection, she developed fever and a deep muscle abscess in her right anterior thigh (the injection site). The abscess was surgically drained and has subsequently healed with no long-term sequelae. It is unknown if Tice BCG was the drug administered. For additional correspondence received on 03/05/01, it was reported, "Reviewed, no additional info at this time." Y Y 08/01/1999 10/01/1999 61 Oct 1999: Gallium Scan - deep muscle abscess right anterior thigh. UNK UNK Cerebral Palsy U2001002510 1
0167386 03/20/2001 IL 0.75 0 .7 F 03/13/2001 Urticarial rash, 4-6 hours, post vax. Y N 03/08/2001 03/08/2001 0 PVT PUB 1
0167387 03/20/2001 MO 1.3 1 .5 F 03/07/2001 On 3/6/01 had wheezing at 10:30 AM and at 14:30 had hives and woke up screaming. Seen at ER on 3/6/01 and given 2 doses of Benadryl. She was also treated for ear infection. Mom states was told to continue Prevnar series. We told pt we would not give at our facility and referred to MD. Directed mom to discuss thoroughly with MD before any further Prevnar vaccines given. Mother requested Prevnar insert be mailed to her. Y Y 03/06/2001 03/06/2001 0 PUB PUB NONE NONE Asthma treated on 2/14/01. MO2001012 1
0167388 03/20/2001 OR 1.6 1 .6 M 03/14/2001 Extreme agitation which lasted a week, night sweats (no fever) which also lasted a week. He had a rash that lasted about 5 days and facial swelling. Y Y 03/07/2001 03/07/2001 0 PVT UNK NONE NONE 1
0167389 03/20/2001 OH 2.0 2 .3 M 03/13/2001 On 3/13/01, received phone call from mom who reported that there is an area of erythema approx. half dollar-sized, hard and seems about 1/2" away from injection site. Y 03/12/2001 03/13/2001 1 PVT PVT NONE Speech delay NONE 1
0167390 03/20/2001 CA 1.0 1 .0 F 03/08/2001 Fever 102F and per grandparent's report; pt shaking and unresponsive X 40 seconds; afterwards was alert and interactive. To ER for evaluation. Missing vaccine information is unknown. Y Y 03/01/2001 03/01/2001 0 PVT PUB NONE NONE NONE CA010020 1
0167391 03/20/2001 CA 1.0 1 .1 F 03/08/2001 On 3/6/01, pt was given vaccinations, and on 3/6/01 and 3/7/01, had a fever of 100F. On 3/6/01, pt had swollen and reddened area in left and right thigh with hard tissue. Mom applied ice. N 03/06/2001 03/06/2001 0 NONE PVT UNK NONE Hypoplasia (L) heart 1
0167392 03/20/2001 IL 4.0 4 F 03/12/2001 One hour, post vax, pt developed hives and was given epi, Benadryl at the ER Y U 03/09/2001 03/09/2001 0 NONE PVT PVT NONE NONE Dermatitis 4/19/99 1
0167393 03/20/2001 HI 3.0 3 M 03/01/2001 1.5 X 2cm red and swollen area at injection site. (per telephone call on 3/12/01) Y 02/27/2001 03/01/2001 2 PVT PUB History of short gut syndrome; mild developmental delays HI0102 1
0167394 03/20/2001 DE 1.4 0 .5 M 03/07/2001 Complained of crying on the night of vaccinations but not constantly. No swelling. Temperature was 100.1F on 3/1/01. Called on 3/5/01 and reported 3 hours of crying, non-stop in the AM with no other symptoms. No swelling or temperature. U 03/01/2001 03/01/2001 0 PVT PVT Mild URI NONE 1
0167395 03/20/2001 AL 2.0 2 .3 F 03/15/2001 Mom states a few hours, post vax, child began breaking out with a weepy rash (hives), erythematous with edema. Rash and edema of lips. Was given Benadryl with relief. No difficulty breathing, wheeze, paleness or dizziness. Instructions given to mom. Mom also stated child had eaten grapes. Y 03/14/2001 03/14/2001 0 OTH PUB Bactroban Rash in face 1
0167396 03/20/2001 DE 80.0 80 F 11/14/2000 Bruise came, 2 days, post vax, on right arm with swelling that appeared on 11/12/00. N 11/03/2000 11/05/2000 2 PUB UNK Blood pressure medicine; Lasix NONE High blood pressure 1
0167397 03/20/2001 FL 5.0 1 .0 M 03/13/2001 Bumps with blisters were appearing even while child was in the office. Also, itching. Treat with Aveeno oatmeal bath and Benadryl. Y Y 03/10/1997 03/01/2001 1452 PVT OTH NONE Seasonal allergic rhinitis; Chronic OM 1
0167398 03/20/2001 OH 22.0 23 F 03/05/2001 Left arm pain, warm to deltoid area, about 1mm red mark, red rash to face, nausea and joint pain. Y 02/12/2001 02/13/2001 1 NONE MIL OTH NONE Sulfa allergy 1
0167399 03/20/2001 CA 39.0 39 F 03/13/2001 About 1 hours, post vax, face got red and puffy; no SOB. Was instructed to take Benadryl and it resolved. Y 02/21/2001 02/21/2001 0 PVT PVT Claritin, Mircette, Prilosec NONE PCN causes multiforme 1
0167400 03/20/2001 WA 28.0 28 F 02/27/2001 Client presented to ER at 21:19 on 1/29/01 with a headache, nausea and vomiting (with bloody emesis), sweats and chills. Received extensive work-up and all was essentially negative except that she was found to be very early in pregnancy, with miscarriage later. Received Compazine/Benadryl and RX for Vicodan/Phenergan suppositories. Continued to vomit, was treated again and discharged on 1/30/01 at 00:25 AM. Returned to ER on 2/1/01 with headache and nausea and vomiting, no rash or meningeal symptoms. Temperature was 99F. Rx'd with IV 2 liters NS. Phenergan, Benadryl and 10 mgm Morphine given IV. Observed and discharged ambulatory. Impression: Headache and adverse reaction to immunizations. Per chart at hospital. Y Y 01/29/2001 01/29/2001 0 Hematology; Chemistry; CT Scan; LP-all neg. Pregnancy test-positive. PUB PVT Shot for birth control, 1st one on 2/21/01 NONE NONE 1
0167401 03/20/2001 MO 1.3 1 .4 M 03/14/2001 2 weeks, post exposure to chickenpox, he ran a low-grade fever, broke out with "only a few small, red bumps with small head to them". Y 06/22/1998 03/12/2001 994 PVT PVT NONE Bug bites 11/97 anemia 1
0167402 03/20/2001 TN 15.0 14 F 03/09/2001 Marble-sized knot above injection site with redness 2-2 1/2" around site including knot. U 03/06/2001 03/07/2001 1 NONE PVT PVT Stomach and ear pain; headache with nausea NONE 1
0167403 03/20/2001 MS 3.0 3 M 03/07/2001 Left upper deltoid at injection site; edema, redness, tenderness and very warm to touch. Y Y 03/05/2001 03/05/2001 0 NONE PUB OTH NONE NONE NONE MS01009 1
0167404 03/20/2001 OR 53.0 53 F 03/01/2001 Muscle in left upper arm ached for about 1 week and then had a bad cold which settled in same location and ached severely for 2 nights; responded to hot cloth application but still minimal aching on 3/1/01. U 01/30/2001 02/01/2001 2 OTH PVT OR200107 1
0167405 03/20/2001 MD 1.0 1 .0 M 03/15/2001 Urticarial and macular, erythematous rash, joint swelling and tenderness. Y 03/01/2001 03/12/2001 11 PCN in future; allergy testing-was also on Amoxicillin PVT PVT NONE NONE 1
0167406 03/20/2001 CA 12.0 12 M 03/09/2001 The pt experienced urticaria rashes. The pt was treated with Prednisone, and Benadryl. U 02/14/2001 02/14/2001 0 NONE MIL MIL NONE NONE allergy to seafood 1
0167407 03/20/2001 NH 60.0 60 F 03/19/2001 The pt felt hot on the way home from the physicians office, then developed a macular papular rash on 3/17 and on the following day 3/18 experienced hives and swelling in the neck. The pt also experienced injection site redness, hardness and warmth to the touch. Saw physician on 3/18 and still had rash on arms, trunk and legs. Y U 03/16/2001 03/16/2001 0 NONE PVT PVT estroderm patch, prometrium NONE NONE NH0110 1
0167408 03/20/2001 TX 35.0 35 F 02/28/2001 Approximately 45 minutes post vax, the pt complained of left arm hurting at the injection site. That evening the arm still hurt but was now red, and swollen and hot to the touch. The pt experienced a high fever with sweats and shakes. He states his head felt like it was going to "explode". Like a migraine headache. Her chest felt like a weight was on it. She could not breathe easily, was breathing fast and deep. The pt experienced muscle spasms. They felt like convolutions in her body. She could not control them. She had light sensitivity and was sensitive to loud noises. She was weak, had trouble walking, sore throat, ear ache, loss of appetite, dizziness and tired. The lymph gland under th left arm pit was very painful and swollen. The left side of mer neck and down her shoulder blade was sore and achy. Y 02/26/2001 02/26/2001 0 PUB PUB PPD NONE 1
0167409 03/20/2001 CA 18.0 1 .6 M 03/16/2001 The pt complained of edema, redness to the right thigh the same day of vax. The redness resolved on 3/15. No fever was noted. Y 03/13/2001 03/13/2001 0 PUB PUB NONE NONE NONE 1
0167410 03/20/2001 MI 2.0 2 .9 F 03/12/2001 The pt experienced a fever and then had 4 seizures. Y Y 03/07/2001 03/08/2001 1 PVT PVT Phenobarbitol, Lamictal, Topamax NONE seizure disorder, lactose intolerant 1
0167411 03/20/2001 IL 17.0 17 M 03/14/2001 On 3/14/01 the pt experienced chest pain, sharp pain on the right side. Respiration did not intensify. The pt experienced intermittent episodes since then. Y 03/09/2001 03/09/2001 0 PVT UNK NONE NONE NONE 1
0167412 03/20/2001 AZ 78.0 78 F 03/13/2001 The pt experienced pain that night which became progressively swollen and red at the injection site over the next 2 days. Treated with ice. No fever was noted. Symptoms were pretty much going by 3/9/01. The pt developed a head cold on 3/11/01. Y 03/05/2001 03/06/2001 1 NONE PVT PVT K-Tab, Estrogen, Maxide, thyroxine NONE allergy to Motrin, ASHD, hypothyroidism, DJD 1
0167413 03/20/2001 MI 1.25 1 .2 M 03/13/2001 The pt experienced a fever of 105 and seizures while febrile. Y Y 03/05/2001 03/12/2001 7 WBC - 14.0, HGB - 10.7, Platelets - 228, BUN - 7 PVT PUB NONE NONE 1
0167414 03/20/2001 WA 40.0 50 F 02/28/2001 2 weeks post vaccine, anthrax, wrists (some swelling), then uticaria (seen) by examiner. U 02/07/2001 02/20/2001 13 None PVT PVT None None. 1
0167572 03/21/2001 CA 25.0 25 F 03/15/2001 Information has been received from a health care professional concerning a 25 year old female who on 4/21/00 was vaccinated with 1 dose of varicella virus vaccine live. Subsequently, the pt learned that she was pregnant; LMP:4/12/00. Follow-up information from the health care professional reported that the pt had a spontaneous abortion. She did not know at what weeks of gestation this occurred. No further information is available. Follow up on 06/29/2001: "Adverse event onset date/time, lot # for vaccine 1 is not provided." Y U 04/21/2000 OTH OTH UNK Pregnancy LMP 4/12/00 WAES00060369 1
0167575 03/21/2001 NH U 03/16/2001 Information has been received from a hospital worker concerning a patient who in February 2001, was vaccinated with Pneumococcal vaccine 23 polyvalent. Subsequently the patient experienced blood clots. Unspecified medical attention was sought. No other Info was available. Upon internal review, blood clots were considered to be an Other Important Medical Event. Follow up on 06/29/2001: "Patient date of birth and age at time of vaccination is not provided." Y U 02/01/2001 02/01/2001 0 OTH OTH UNK UNK WAES01030309 1
0167581 03/21/2001 GA 32.0 31 F 03/12/2001 Information has been received from a 32 year old Caucasian female pt who on 3/12/99 was vaccinated with a 1st dose of varicella vaccine. On 3/15/99, the pt discovered she was pregnant. It was noted that the pt was 4 weeks pregnant at the time of the vaccination. On 11/14/99, the pt gave birth to a female. On 3/1/01, it was reported that the child is now 15 months old and is not talking or walking. She had no current medications or allergies. The child's hearing has been tested and seems fine. The mother reports that when the child is spoken to "she seems confused". The child responds to activity around her with "high-pitched screaming and low guttural sounds". The only word she says is "dada" and that is only when she is excited. A neurologist is conducting tests on her and will be performing on MRI. It was also reported that the child has a rotated sacrum on her right side. Upon internal review the pt's experiences were considered to be "Important Medical Events". Additional information has been requested. Pt has compulsive personality disorder, and lactose intolerance. The update was on thebabies condition. This report is part of the pregnancy registry. Follow up on 06/29/2001: "Adverse event onset date/time and lot # for vaccine 1 is not provided." Y U 03/12/1999 Hearing Test - fine. Beta-Human Chorionic - 03/15/99 - positive. OTH OTH Prozac Pregnancy (LMP-UNK); Compulsive personality disorder; lactose intolerance WAES99031024 1
0167584 03/21/2001 UT 39.0 39 M 03/06/2001 After the patient received his vaccine, he said it was like he had went to the dentist, the left side of his face was numb. The next day his eye was giving him trouble. On the third day his mouth was not working. They bandaged the eye up to keep it moist. Y Y N 11/24/2000 11/24/2000 0 OTH OTH Diabetes, High blood pressure. 1
0167585 03/21/2001 FL 0.75 0 .8 M 02/26/2001 This patient was immunized on 2/19/01. That evening the patient developed a fever of 101 rectally, which continued until the day of admission. On 02/21/01, the patient developed strabismus of the left eye. The patient admitted to the hospital on 02/23/2001 with a diagnosis of viral meningitis. On 02/25/01, the patient developed right eye strabismus with developing improvement of the left eye. The patient was discharged clinically stable. A physician reported via a company representative that an 8 month old male received his second injection of prevnar on an unspecified date. Subsquently, the child was hospitalized for aseptic meningitis. Follow up information received on 03/16/2001, from the child's physician revealed that on 02/19/2001, the child received vaccination with Hib-Titer and Tripedia vaccines along with his third dose of prevnar, not his second dose as previously reported. The child has since recovered. From follow-up information received on 05/01/2001, it was reported that for the request for the discharge summary with complete diagnosis and the results of cerebrospinal fluid examination need records from hospital. Additional patient, vaccine and the adverse event onset information were provided. From follow-up telephone conversation, it was stated that the reporting facility did not receive any records from the hospital because they did not admit the patient. The patient and family have since moved without forwarding information. Y Y 5 Y 02/19/2001 02/21/2001 2 MRI with and without contrast - Neg. CT scan of the brain without contrast - Neg. LP - ORBC, 48 WBC, 94 Mono, 6 Poly, 63 Glucose, and Prot 20. PVT UNK NONE NONE 1
0167586 03/21/2001 TX 7.0 7 M 03/14/2001 The patient had redness, swollen right arm, erythematous area of 5 cm diameter around the site of injection. Y 2 Y 10/27/2000 10/28/2000 1 NONE PVT OTH NONE NONE NONE 1
0167587 03/21/2001 CA 4.0 1 .6 M 03/12/2001 This patient had a loss of expressive / receptive speech, gastrointestinal problems, following his 06/10/98 vaccinations. Also Strabismus, visual problems, autism diagnosis, candidiasis, and rashes. The follow up received on 7/5/01 states, "pt is a 2 year 3 month old boy who has been referred to the clinic by his parents for a full developmental assessment. Pt lives with his parents, and his older brother. Pt was accompanied to the clinic by his parents. This evaluation occurred over two visits. During the first visit, Dr. interviewed pt's parents to obtain relevant developental, medical, and family history. On the second visit, pt was assessed formally by Dr. to obtian an estimate of his current level of functioning. Following this, both Drs. observed his unstructured play. Also a spart of this evaluation. Drs. reviewed any previous evaluations. This second clinic visit concluded with an extensive parent conference during which results of psychological testing, diagnositic impressions, and recommendations were discussed. Pt's parents report the following concerns: speech and language delay, lack of eye contact, toe walking and hand flapping, finger pulling to communicate, recent increase in temper, and tuning out. His parents reported that he has also been diagnosed as having candida yeast overgrowth and Giardia in addition, to casein and gluten intolerance. They are seeking this evaluation to understand his diagnosis and prognosis. They also report that he has visual problems, which consist of strabismus. They have questions regarding hwo his visual problems could be affecting his development. Pt's parents reported htat they were concerned about his developemtn when, in October of 1998, onc eo fhis eye started to drift inward. At the same time he became unreponsive to their verbal overtures. For example, he woul dnot respond when his name was called. In November and December his parents noted that pt's motor skills had changed. In genearl, he appeared to have balance." Y N 06/10/1998 10/16/1998 128 Genetics tests-nml PVT OTH NONE NONE 1
0167588 03/21/2001 MN 1.25 1 .3 M 03/14/2001 Left thigh with 11cm X 8cm area of erythema, edema and warmth. Temperature of 100F (R). Y U 03/13/2001 03/14/2001 1 PVT UNK NONE Milk and egg allergy 1
0167589 03/21/2001 CA 1.6 0 .8 M 03/05/2001 Vomiting and diarrhea developed immediately, post vax. Vomiting stopped after 3 days; diarrhea continued for 2 weeks. Pt had this same reaction with Prevnar #2 & #3 though not with #1. Y Y 02/06/2001 02/06/2001 0 NONE PVT PVT NONE NONE NONE Vomiting and diarrhea~Pneumo (Prevnar)~2~0.60~In Patient 1
0167590 03/21/2001 IN 2.0 2 .6 M 03/15/2001 5cm area of redness and swelling on left deltoid reported the evening following injection day. Doctor on call, recommended that mother give Tylenol for discomfort and ice to area. Seen the following AM. No change in treatment. Y Y 02/13/2001 02/14/2001 1 NONE PVT PUB Tylenol for pain and fever NONE Mild intermittent asthma 1
0167591 03/21/2001 CA 1.25 1 .4 F 03/13/2001 Vaccine given on 3/12/01. Pt's mom states this morning, she noticed a rash patch on left thigh and right arm. Now she has "patchy" rash all over her body except her face. Mom doesn't recall the temperature last night. States "not that high". Y 03/12/2001 03/13/2001 1 PVT PUB NONE URI NONE 1
0167592 03/21/2001 AZ 0.4 0 .2 M 03/13/2001 High-pitched screaming for more than an hour on day of shots. Y 12/04/2000 12/04/2000 0 NONE PVT PVT NONE NONE 1
0167593 03/21/2001 MT 1.0 1 .0 F 03/19/2001 The pt experienced a fever of 105 the same evening of the vax. Y 02/15/2001 02/15/2001 0 NONE PVT UNK NONE NONE 1
0167594 03/21/2001 NY 71.0 20 M 05/20/2000 My concern is that the series of the 3 Lymerix vaccinations have affected my memory and loss of words in conversations. I would like to know if there is any information that might or might not verify my problem. U 02/17/2000 PVT OTH NONE 1
0167595 03/21/2001 36.0 36 M 03/30/2001 Within 12-24 hours post 7th anthrax vax, the pt noted an onset of mild erythema, swelling, tenderness in an area of 3cm x 4cm around the injection site. Similar reaction occurred with 6th shot but not with any others. Y 03/11/2001 03/13/2001 2 NONE MIL MIL NONE NONE gastroesophageal reflux, NIDDM Swelling~Anthrax (no brand name)~6~35.00~In Patient 1
0167596 03/21/2001 AK 34.0 34 M 03/02/2001 Extreme sensitivity in pads and tips of all fingers, followed by subdermal bumps and blisters. Blisters eventually (over 3-4 days) worked to surface and broke (water only). I reported effects to clinic then but was told it wasn't a symptom. Blisters eventually stopped appearing over 4 months period. Y 03/11/2000 03/11/2000 0 NONE MIL MIL NONE NONE NONE 1
0167597 03/21/2001 CA 78.0 78 M 03/12/2001 Fever, pleural effusion, Eosinophils in fluid and marked Eosinophils in peripheral blood. Y Y 11/27/2000 12/02/2000 5 CBC; CXR-Pleural fluid; multiple blood tests PVT PVT Levothroid; Indocin; Valium NONE Allergy to PCN; Hypothyroidism, BPH 1
0167598 03/21/2001 WA 20.0 20 F 03/15/2001 Roughly 1 hour, post vax, developed chest tightness, SOB, itchy rash, with pruritus, mild wheezing and periorbital edema but vitals stable. Received Epi, Benadryl and albuterol nebulizer. Resolved, sent home with prednisone. Y Y 03/15/2001 03/15/2001 0 NONE MIL MIL ibuprofen NONE 1
0167599 03/21/2001 NY 36.0 36 F 03/12/2001 On 1/14/01, lost peripheral vision in right eye for 20-30 minutes. Rash on chest on 1/16/01. Upper left arm hurts on occasion; possibly pulled muscle? Y 01/09/2001 01/14/2001 5 Later testing for immunoglobulin; IgG; IgE; IgM-all nml; T and B cell # and liver functions-all tests nml PUB PVT Xanax, birth control, vitamins, nystatin Oral thrush Anxiety/panic disorder; Allergic to Novocain, doxycycline, codeine and Augmentin. 1
0167600 03/21/2001 MI 2.0 2 .7 F 02/09/2001 Mom phoned clinic on 2/2/01 with complaint of fever. No provider available. Advised to give Motrin for fever and monitor. Mother denies redness or swelling. Advised to seek ER if no improvement. On 2/6/01, presents in clinic with complaint of still having fever. Reports the site of injection swelled up 2 times normal size. No swelling at this time. No fever. Y Y 02/01/2001 02/02/2001 1 OTH PUB NONE NONE NONE 1
0167601 03/21/2001 IL 1.25 1 .3 F 03/10/2001 Started to run a fever approx. 1 week, post vax. On 10/3/00, her whole body turned purple. Her temperature in the ER was 105F (R). Y Y 09/22/2000 10/03/2000 11 Blood, Urine and throat cultures were negative. PVT PVT NONE NONE NONE 1
0167602 03/21/2001 MO 4.0 1 .0 M 03/10/2001 Varivax lesions. U 04/23/1997 03/09/2001 1416 PVT UNK NONE NONE 1
0167603 03/21/2001 WI 7.0 7 M 03/14/2001 Pt's mother stated he displayed marked increase in tics, post vax. He had tics prior to vaccines. Affect of increased tics more noticeable after environmental stimulation. In clinic only minimal evidence of tics activity on 3/13/01. Note: mother believes older sibling had permanent (neurologic) changes following immunizations. Y U 01/30/2001 02/01/2001 2 NONE PVT PVT Medicated for ADD History of Autism, ADD, Tics 1
0167604 03/21/2001 MN 17.0 17 F 03/15/2001 Purpuric rash and arthralgia Y 11/09/2000 11/09/2000 0 11/13/00; WBC-13.2 Hgb and platelets-nml; Step culture serum neg. PVT PVT NONE NONE NONE 1
0167605 03/21/2001 CA 40.0 40 F 03/14/2001 50 mm X 80 mm reddened, hot to touch and indurated area. Prescribed Dicloxacillin. Y U 03/12/2001 03/14/2001 2 NONE PVT PUB Motrin, Elavil NONE Rheumatoid Arthritis; DJD 1
0167607 03/21/2001 NY 1.0 1 .0 F 03/15/2001 Erythematous, edematous right thigh in vastus lateralis. Mother given instructions to use Tylenol and apply ice to local area. Y 03/07/2001 03/08/2001 1 None PUB PUB NONE Anemia NONE 1
0167608 03/21/2001 LA 3.0 3 M 03/15/2001 Pt developed swelling, warmth and erythema at injection site, 24 hours, post vax, extending from deltoid to elbow and left anterior chest. No fever. Started on steroids, antihistamines and some antibiotics. Y U 03/13/2001 03/14/2001 1 PUB UNK NONE NONE Asthma 1
0167609 03/21/2001 CO 39.0 39 M 03/14/2001 Had a fever under 100F for 3 days; rapid pulse that lasted for 1.5 days; hives for which took Claritin and it went away after about 4 hours; weakness for 4 days and jaw soreness that lasted 2 days. Y 02/14/2001 02/15/2001 1 PVT UNK NONE Penicillin allergy 1
0167610 03/21/2001 OH 0.5 0 .5 M 03/13/2001 On 3/7/01, developed a shrill cry at approx. 18:30. Right leg was red and warm. Bulging fontanel, P-170 (mom is a nurse). Took to ER and they recommended Advil instead of Tylenol. On 3/8/01, pt was irritable with no appetite. On 3/9/01, pt was not sleeping well and had 2 loose stools. On 3/10/01, had a fine red, rash on trunk and back of neck, a shrill cry and took to Urgent Care and was told to "watch him". On 3/11/01, eating better and was his happy self and rash was fading. Y Y 03/07/2001 03/07/2001 0 PUB PUB NONE NONE NONE 1
0167611 03/21/2001 HI 4.0 4 F 03/13/2001 Verbal report; redness (1/2" X 1"), slight swelling and tenderness to site of DTAP. U 03/12/2001 03/13/2001 1 PVT PUB NONE 1
0167612 03/21/2001 MS 1.0 0 1 M 03/14/2001 Mild case of varicella on 3/7/01. Y 10/27/1999 03/06/2001 496 PVT PUB Augmentin, albuterol ROM; RAD Anemia 1
0167613 03/21/2001 CA 4.0 4 M 03/08/2001 Pt presented to clinic 2 days, post vax, with large local reaction on the left thigh. Pt didn't appear to be in distress. Mom says he complained of itchiness at the site. As per doctor, advised her to use warm compresses and give Tylenol for discomfort. She's to follow-up if no improvement. U 03/06/2001 03/07/2001 1 PUB PUB INH for (+) PPD Constipation Behavioral issues 1
0167614 03/21/2001 FL 1.0 M 03/13/2001 Parotitis U NONE PVT PUB NONE NONE 1
0167615 03/21/2001 IA 4.0 4 M 03/12/2001 Significant swelling of the left arm with erythema of the skin, involving the forearm as well. Measurements: left bicep 9 1/4"; left forearm 7 1/2"; right bicep 7 1/2"; right forearm 7 1/4". Y Y 03/09/2001 03/10/2001 1 PVT PVT NONE 1
0167616 03/21/2001 MO 46.0 46 F 03/12/2001 Pain, redness and swelling within 3-4 hours, post vax. Later in the day on 3/8/01 had diarrhea and swelling of finger on left hand. On 3/9/01, had rash and pruritus at injection area and during the day it developed in a generalized body rash with itching. On 3/10/01, the rash and pruritus diminished. Treatment: put heat at injection site on 3/8/01 and 3/9/01. Called her doctor and he ordered Tylenol and rest. Y 03/08/2001 03/08/2001 0 NONE PUB PUB Inhaler for asthma NONE Asthma; Allergic to PCN and other antibiotics MO2001013 1
0167617 03/21/2001 KY 5.0 4 F 03/14/2001 On 10/3/00, had fever of 102F within 24 hours and diarrhea. Then eyes were swollen; itchy neck; red splotches on neck and legs. Received Motrin during this time every 6 hours from time of vaccination. At this time pain "doubled" from Hep-B. Mom wanted to refuse Hep-B #3. PMD signed medical exemption for anaphylactic reaction. Y Y 10/02/2000 10/03/2000 1 PUB PUB Motrin NONE Allergies to PCN and Sulfa KY2001019 1
0167618 03/21/2001 TX 48.0 48 F 03/08/2001 Pt stated that she experienced extreme pain and swelling at the injection site and entire arm was red and swollen. Symptoms continued and worsened, unrelieved by pain relievers, so she went to ER for treatment. Y Y 10/10/2000 10/11/2000 1 UNK PVT PUB NONE NONE NONE 1
0167619 03/21/2001 KY 18.0 18 F 03/08/2001 Pt states she began experiencing pimply areas on her neck, 2 hours, post vax. She continued experiencing skin dermatitis, swollen eyes and low-grade fever up to 3/8/01. Went to MD and was told she had skin dermatitis as a result of a reaction to the shot and also was dx'd with shingles. She was given Famvir 500mg TID. Y Y 03/02/2001 03/02/2001 0 NONE PUB PUB Pt complained of skin irritation on left lateral trunk, prior to vaccination. Allergic to sulfa drugs, Entex LA, Robitussin KY2001018 1
0167620 03/21/2001 KY 9.0 9 M 03/12/2001 Vaccine given on 3/5/01. Symptoms of fever to 102.6F; itching and pox appeared on 3/8/01 PM. Initial 72 pox with 4 in mouth area, 17 blisters and red spot on remaining. Child broke out worse and was seen by PMD on 3/9/01. Used Tylenol, Benadryl and Motrin for discomfort. Mother reports has pox everywhere; over 1,000 in mouth, ears, throat, nose. Had difficulty urinating. Y N 03/05/2001 03/08/2001 3 NONE PUB PUB NONE NONE Allergy to Bactrim and PCN KY2001017 1
0167621 03/21/2001 AL 1.3 1 .4 M 03/16/2001 Left thigh with 7 X 4 cm redness superficial with marked swelling and induration of thigh approx. 10 X 12cm; noted approx. 18 hours, post vax. Treated with Benadryl and Motrin. N 03/15/2001 03/16/2001 1 NONE PVT UNK NONE NONE NONE 1
0167623 03/21/2001 CA 76.0 77 F 03/20/2001 The pt, a 77 year old female, reported that within 3 days, post vax, she developed flu-like symptoms of general aching all over her body, weakness, loss of appetite; physical condition continued to worsen each day. By the 4th day, she experienced difficulty breathing. She was seen in the ER where, after X-ray, 1 liter of fluid was removed from her lung. Eleven days, post vax, she developed itchiness, rashes and small blisters on her back, inner thighs and ankles. The fronts of her legs had red, feverish lumps beneath the surface of skin, with fluid retention around her ankles. The rash subsided within a week, but the heavy welts on her feet and palms of hands and itching persisted for 10 more days. All adverse events, except the ankle edema have completely resolved. The ankle edema continues to be treated with HCTZ, 25 mg per day. The pt stated that the dx of "pleural virus" was made. No additional information is available. Y U 11/17/2000 11/20/2000 3 CXR-fluid in lung; CXR-neg for cancer; CT-3 small spots on liver; EKG-UNK PVT OTH Lysine, multivitamin, calcium Post right breast lumpectomy for breast cancer, treated for 4 years with Tamoxifen. MPI2001037380 1
0167679 03/21/2001 PA 33.0 33 F 04/26/2000 A physician reported that a 33 year old female inadvertently, received an injection of Diphtheria and Tetanus Toxoids Adsorbed Ultrafined, Pediatric on 3/14/00 and experienced an injection site reaction characterized by swelling, redness and pain. The pt also developed a fever. On 3/16/00, she was treated with Augmentin and recovered on 3/23/00. Information received from the vaccine provider on 4/20/00 supplied pt data and stated that the pt recovered. Y 03/14/2000 03/14/2000 0 UNK PVT OTH Prilosec UNK GERD; Hiatal hernia HQ1739022MAR2000 1
0167680 03/21/2001 CA 0.57 0 .6 F 02/01/2001 The infant inadvertently received an injection of Tetramune from a lot that had expired. The report was received 8 days post vax and no adverse experience had occurred at that time. Additional information received on 1/30/01 from the physician indicated that the infant developed a "slight" fever and "slight" redness at the injection site. She recovered after a "few" days. Y 10/25/2000 UNK OTH OTH NONE NONE UNK HQ3128502NOV2000 1
0167681 03/22/2001 KY 0.2 0 .2 M 02/20/2001 No data provided. Y 02/20/2001 N 02/19/2001 02/20/2001 1 PUB PUB Asthma KY2001020 1
0167682 03/22/2001 IL 42.0 42 F 03/07/2001 Information has been received from a registered nurse concerning a 42 year old female, was vaccinated with a 1st, 2nd, and 3rd dose of Hepatitis B vaccine on 05/28/99, 06/28/99, and 01/19/00 respectively. After the 1st and 2nd dose, the patient "felt funny". Prior to receiving her 3rd dose, the patient was seen by her physician as she had recently recovered from bronchitis. The patient was advised to receive the 3rd dose, and at 9 AM on 01/19/00, she was administered the vaccine. Two hours after the 3rd dose, the patient "felt funny". By 5 PM, the patient had developed a more "significant" reaction than after the previous two vaccinations and reported extreme tightening in the chest and sore throat. By 7 AM on 01/20/00, the patient had developed difficulty breathing and went to her physician where the doctor administered Benadryl and Prednisone. The patient's experiences of difficulty breathing, sore throat, and tightening in the chest were considered to be other important medical events. The patient recovered and has not had any problems since. Additional info not expected. Y Y 05/28/1999 05/28/1999 0 OTH OTH UNK UNK WAES00012534 1
0167683 03/22/2001 TX 1.3 1 .4 F 03/01/2001 Vomiting, diarrhea, weakness, paleness, no appetite, bruising, tenderness at site, drowsiness, unresponsive and bleeding at the injection site up to 30 minutes after administered. Y Y 1 Y 01/15/2001 01/17/2001 2 NONE PVT OTH NONE NONE Ear infections 1
0167684 03/22/2001 KS 0.3 0 .3 F 03/15/2001 Within 1/2 hour of shots the pt developed a fever of 106 (rectal) with "measles" type rash. The child was fussy the rest of the afternoon. Given Motrin and Tylenol alternately. Y 01/15/2001 01/15/2001 0 PUB UNK NONE NONE 1
0167685 03/22/2001 IA 0.25 0 .3 M 03/14/2001 The parent stated that the pt experienced an elevated temp to 105 with Motrin being given at 4 hours. The pt went to the ER with unknown labs. This event lasted 48 hours. Y Y 12/26/2000 12/26/2000 0 UNK PUB PUB Amoxicillin recovering from Otitis Media IA01004A 1
0167686 03/22/2001 KY 4.0 4 M 01/25/2001 The pt developed a temp of 103.2. The pt's mother gave him Tylenol prior to school in the AM. Y 01/23/2001 01/24/2001 1 PUB PUB Digoxin, Lasix, Coumadin, hypo-plastic left heart syndrome KY2001005 1
0167687 03/22/2001 NY 1.7 1 .7 M 03/19/2001 20-25 minutes of unconsolable crying, uncontrolled crying, swelling, and slight redness. Y 03/16/2001 03/17/2001 1 PVT UNK Tylenol URI, rhinorrhea, nasal congestion, and fever 1
0167688 03/22/2001 NY 47.0 45 F 03/20/2001 Approximately 6 months post vax, the pt complained of pain in her left elbow. She was seen by an orthopedist who diagnosed her with tendonitis and prescribed unspecified anti-inflammatory medicine and exercises. Per the pt, the orthopedist "did not relate the complaint to Lymerix". The pt experienced joint warmth as well. Six months later, in 3/00, the right elbow became painful. At that time, the pt did not seek treatment. In 2/01, the pt complained of right knee pain and was seen by the physician. The pt stated that MRI of right knee confirmed arthritis under knee cap and torn cartilage". Per the pt, the bilateral elbow pain has not resolved as well as the knee pain. As of 3/13/01, the outcome of the events is ongoing. Y N 03/01/1999 02/01/2001 703 MRI - right knee arthritis and torn cartilage PVT PVT 20010065331 1
0167689 03/22/2001 VA 4.0 4 M 03/15/2001 This child received immunizations of DTaP #5 on 03/13/01 on left upper arm and came in on Friday, 03/15/01 with a complaint of left arm pain, redness, swollen and hard with circumference of 9 3/8'' (+) erythema and edema. Will follow up tomorrow on 03/16/01 to recheck site. Y 03/13/2001 03/15/2001 2 PVT PVT NONE 12/00 bit by a dog, bad hives for 5 days. 1
0167690 03/22/2001 IN 5.0 5 F 02/26/2001 This child received DTaP, IPV, and MMR on 2/21/01. The mother reported arm swollen, hard, and red. The doctor put the child on antibiotics (pending for doctors note). Y Y 02/21/2001 02/23/2001 2 PUB PUB NONE IN20014 1
0167691 03/22/2001 IN 1.0 1 .0 F 02/26/2001 This child had a rash, elevated temp, runny nose, cough, and swollen glands. Y Y 02/15/2001 02/23/2001 8 PUB PUB NONE NONE IN20013 1
0167692 03/22/2001 IN 1.6 1 .6 M 02/12/2001 This patient's mother called at 8 PM on 02/12/2001, stated that the baby had welts on his left thigh 30 minutes after the immunizations. Given on 02/09/01. By 12 noon on 02/10/01, the baby broke out with hives all over his body. The baby developed a croupy cough, a temperature of 103F, and difficulty breathing. Went to the ER on 02/11/01 AM and was given Benadryl and sent home. Y Y 02/09/2001 02/09/2001 0 PUB PUB Low platelets @ birth. IN20015 1
0167693 03/22/2001 VA 10.0 10 M 01/24/2001 This child had a Hepatitis B injection #2, 01/23/01. After school symptoms of an achy stomach, temp of 99.0 at 3:30 PM, and 102.7 at 4:50 PM. No pain or redness at the injection site. No problem with first Hepatitis B shot. The patient was seen in the doctors office the next day 01/24/01, it is believed that he has the flu, the Hep B shot from the day before causing the reaction is totally coincidental. Y Y 01/23/2001 01/23/2001 0 NONE OTH PUB NONE NONE NONE VA01009 1
0167694 03/22/2001 PA 16.0 10 M 03/19/2001 The patient's mother called on 03/16/01, stated the child had a headache and marks on his body. He was seen in the doctors office positive chicken pox approximately 20 total. Y 07/24/1995 03/16/2001 2062 PVT PVT NONE NONE NONE 1
0167695 03/22/2001 PA 2.0 1 1 M 03/19/2001 This patient's mother called on 03/16/2001 and stated the child broke out with the chicken pox in the face, elbows, ears, and stomach. Y 09/15/1995 03/16/2001 2009 OTH OTH NONE 1
0167696 03/22/2001 GA 1.25 1 .2 F 03/15/2001 This infant became unconscious a few hours after the vaccine. Started vomiting. Called a nurse help line for advise. The child was taken to the ER. Follow up: Since I have had both my children experience severe allergic reactions to vaccines (which have been reported), I expect a follow up phone call interview. Y Y 12/17/1999 12/17/1999 0 PVT PVT NONE NONE 1
0167697 03/22/2001 CT 9.0 9 M 03/09/2001 On 03/07/2001, the patient received MMR #2 and Hep B #1. From 03/08/01, he had a skin rash, maculo erythematous trunk and face. No fever, no systemic symptoms. U 03/07/2001 03/08/2001 1 PVT UNK PPD, Pasteur, lot #C0152AA, right forearm, 03/07/01. NONE 1
0167698 03/22/2001 NY 50.0 49 F 03/19/2001 This patient complained of pain in the left shoulder area. She was examined at the doctors office on 12/09/00 ( 2 month later) and found no physical signs of reaction nor disability (no swelling, no ecchymosis, no wasting, full range of motion intact, sensory and motor intact.) Expected re-examination on 03/09/01, but did not go. Follow up: adverse event onset date/time is not clear. U 10/20/2000 PVT PVT NONE NONE NONE 1
0167700 03/22/2001 NE 0.5 0 .5 M 03/19/2001 This infant had Advil, went to the ER at 10:30 PM, had a temperature of 104, HR > 200 bpm. He was placed on a monitor, given Tylenol. Fussiness and temp began 1 hour post-vaccination and continued for 48 hours. Y Y 03/15/2001 03/15/2001 0 Spinal tap - unknown labs. PUB PUB Motrin before vaccinations. IA01004B 1
0167746 03/22/2001 CO 2.0 M 06/15/2000 It was reported that a 2 year old male patient received a ProHIBit vaccination on 03/30/00. The same day the patient developed hives and angioedema. The patient was treated with Epinephrine, Benadryl, Tagamet, and Pedispred. Y U 03/30/2000 03/30/2000 0 UNK UNK Strong Allergy History U2000004680 1
0167747 03/22/2001 TN 11.0 F 10/11/2000 It was reported that an 11 year old female patient received a ProHIBit vaccination on 08/25/00. Reportedly the patient developed a large area of erythema and fever. Onset date not reported. Further info requested. U 08/25/2000 UNK UNK U2000007150 1
0167748 03/22/2001 TN 11.0 F 10/11/2000 It was reported that an 11 year old female patient received a ProHIBit vaccination on 08/25/00. Reportedly the patient developed large area of erythema and a fever. Onset date not reported. Further info requested. U 08/25/2000 UNK UNK U2000007160 1
0167703 03/23/2001 CA 0.25 F 03/20/2001 Information has been received from an investigator regarding a 3 month old female who received her first dose of Prevnar as part of a post-marketing safety surveillance trial. At 39 days, post vax, the infant died due to Sudden Infant Death Syndrome. Both the medical monitor and the investigator agree that this event was not related to the vaccine. A follow up report received 4/13/2001 adds: Upon further review, this case is being forwarded to as a 15 day alert report per agreement with the FDA. MANUFACTURER'S NOTE: Upon case review on 04/11/2001, this report was found to be a duplication of report with case ID #HQ7326116FEB2001. Therefore, this case has been canceled and informational contents merged with HQ7326116FEB2001. Y N UNK OTH OTH UNK UNK gastroesophageal reflux HQ7750127FEB2001 1
0167704 03/23/2001 PA 80.0 80 M 03/19/2001 This patient was admitted to the hospital on 11/01/00 and died on 11/12/00. The patient was examined and given a flu shot on 11/01/00, he had shortness of breath and sore legs, so the doctor wanted to do a CXR, R-Tibia X-ray, and a EKG. His diagnosis was osteoporosis. The patient was taken to the ER on 11/01/00 at 10 PM because he had terrible tremors, fever, weakness, and nausea. The patient was immediately admitted to the hospital and he told the doctor of his flu shot the doctor said he had a mild heart attack, had a high fever, and there appeared to be an infection in his lungs. The patient had two previous bouts with pneumonia treated with antibiotics an no lung problems since then. The patient was put in the ICU on a respirator. Saw an infectious disease doctor who focused on his right leg because she thought there might be an infection but there was no sign of infection. The patient was eventually put in telemetry on the 8th floor. He had a monitor that would show signs of a heart attack at the nurses station. His fever was still high and the wife was told they would watch her husband to make sure the fever goes down but there were no cold blankets, no ice packs. He was on a nose device for oxygen. The wife and friends observed a lack of activity in looking in on the patient. By Sat. there was no news as to the infection or the fever. On Sat. night the patient spent time with his wife had two visitors who thought he was bloated, he was weak, when he went to the bathroom. Prior to his trip to the bathroom the wife noticed that he did not have his oxygen nose piece in. It was carefully wrapped and hanging in the back of the patient's bed. The patient said they took it off. That evening when the wife left she asked for the nurses to help and look in on her husband because he was weak and could fall and hurt himself. That evening about 8:30 PM the wife received a phone call her husband took a turn for the worse and was being put back on a respirator and back into ICU. When she arrived she was not able to see her husband until 10:30 PM, three nurses assured her that he had been in the bathroom and had an attack, while they were with him. A female resident told the wife she had to put a tube down his throat because he could not breathe. The next three days were critical (the doctor said the next 24 hours). The patient was very weak, his kidney were slowing. By Thursday he improved and the respirator was removed. They were going to test him, he was put in a chair and strapped; he swallowed soft items; he was at first disoriented (ICU psychosis) as the nurses and doctors put it. He then wanted water and said his throat hurt. He was moved back to Telemetry on Friday afternoon was alert and talking. The doctors were told again of the patient's recent flu shot before his attack and the doctors could not believe it. They were more concerned with the patient lungs than his heart. The doctor told the wife that the patient had congestive heart failure and sometimes a bigger attack occurs after a small one. The family never knew of his congestive heart failure. To the family's knowledge he was not ordered to curtail some heavy activities. The patient was put on an ice blanket because the fever was up. The wife requested for his move back up to the 8th floor that her husband be put across from the nurses station and not at the end of the hall, the doctor noted that. The wife asked why he was being taken off from the monitor so fast. The patient was still weak, he could not move his arms, his speech was weak. About 9 PM on Saturday the patient's sugar was high 300+. He needed insulin, and his wife requested that they make sure he sipped some ensure or he would bottom out. The wife was worried about her husband at this point a nurse had said he was "very sick" so she requested to speak with the doctor in the morning (Sunday) and reminded the nurses he had a living will on file. The patient told his wife she'd better go it was getting late and that was the last time she saw her husband alive. She received a call at approximately 3 AM that he had taken a turn for the worse, same night, same staff, same floor as the previous week. The wife reminded the nurse of the living will. When she arrived at the door of her husbands room she found 25 people in the room with paddles, pumps, respirators, electronic shocks. She screamed at the same resident from the previous week that she should have know better, that they had talked. She asked why they had put her husband through that when she talked about this very thing with the nurses around 10 PM that night. The resident said oh you didn't want us to do it, she then turned around went back into the room and told everyone to stop. The resident told the wife that her husband was not breathing and they did everything to revive him. The wife stated that this is not what her husband wanted and asked everyone in the room how would they feel if it was their son or husband. The husband was dead and the wife had several questions. Y 11/12/2000 N 11/01/2000 11/01/2000 0 UNK UNK Cancer, heart attack 1999, Cataract surgery 2000, pneumonia 2x. 1
0167705 03/23/2001 CA 0.2 0 .2 F 03/16/2001 Within 48 hours post vax, the baby died from SIDS in the ER department. Y Y N 01/29/2001 01/31/2001 2 UNK PUB NONE 1
0167714 03/23/2001 AR 5.0 5 M 02/23/2001 The pt experienced a seizure on 2/22/01 at 4:00 PM. Y 1 Y 02/15/2001 02/22/2001 7 PUB PUB NONE ~DTP (no brand name)~1~0.50~In Sibling AR0115 1
0167715 03/23/2001 NY 1.0 1 .0 M 03/08/2001 This infant had a febrile seizure, temp of 105; five days after his MMR, Varicella, and Prevnar, immunization. Y Y 01/29/2001 02/02/2001 4 Blood Culture - Neg x 48 hours PVT PVT NONE NONE 1
0167716 03/23/2001 KS 0.5 0 .5 M 03/19/2001 This infant was immunized on 03/15/01. The mother reports the child developed "tic" in which the child twitched head to one side. On the night of 03/17/01, the child had 2-3 generalized shaking episodes which lasted 3 seconds each, followed by a glazed / lethargic look. This was not typical seizure activity. However unsure. Patient to see a neurologist. Y U 03/15/2001 03/17/2001 2 CT Scan, CBC, Chemistries - WNL. MIL MIL NONE NONE 1
0167717 03/23/2001 AZ 0.2 0 .2 F 03/15/2001 This infant was screaming for 2 hours after her injection and redness appeared at the sight on the left thigh. Y 03/09/2001 03/09/2001 0 PVT PVT URI 1
0167718 03/23/2001 AL 1.25 1 .3 F 03/15/2001 This infant had DTaP and Prevnar injected at separate sites of the right upper arm. No sterile abscess, but muscle swollen, slightly tender, red blotches on upper arm 7 cm x 2 cm around the injection site, 3; 1 x 1 cm 65 inch posteriorly upper arm and 2 smaller blotches below the injection site. 3 x 2 cm and 1 cm diameter not warm or indurated, no hives. Y 03/13/2001 03/14/2001 1 NONE PVT PUB NONE Recurrent otitis media, bronchospasm. 1
0167719 03/23/2001 MT 0.3 0 .3 M 03/16/2001 This infant had a papular rash at each injection site. Y 03/13/2001 03/14/2001 1 NONE PVT PVT NONE Cold symptoms NONE 1
0167720 03/23/2001 UT 0.25 0 .4 F 03/16/2001 This child had a temp of 104, irregular breathing, cyanosis, twitching, and jerking, this all was observed at home by the parents. The infant was taken to an after hours clinic. Onset of symptoms approximately 1 hour after receiving vaccine. Apnea monitor ordered. Y Y 03/08/2001 03/08/2001 0 CBC, Blood culture. PVT PUB NONE 34 week gestation, gastroesophageal reflux. 1
0167721 03/23/2001 NC 0.75 0 .8 M 03/15/2001 This infant took a small nap after his shots. He woke up around 1 PM, with inconsolable crying and screaming until around 5:30 PM when he napped again. Y 03/14/2001 03/14/2001 0 PVT PUB Advil and Tylenol. Cold Symptoms. NC01034 1
0167722 03/23/2001 NC 2.0 1 .9 F 02/28/2001 This child had a large erythema reaction to Prevnar. Erythema measures 9 cm x 5.5 cm. Y 02/26/2001 02/27/2001 1 NONE PVT PVT NONE NONE NONE NC01031 1
0167723 03/23/2001 NC 1.0 1 .0 M 03/13/2001 This infant had a fever of 103 (2 hours after his vaccine temp 102), he cried for 6 hours, and the fever persisted for 24 hours. The patient was treated with Motrin at home he was very irritable. Y Y 03/12/2001 03/12/2001 0 Will follow up with blood work if his temp continues greater than 101 on 03/14/2001. PVT PUB NC01032 1
0167724 03/23/2001 IN 1.0 1 .0 F 03/22/2001 This patient had cellulitis at the injection site, with a varicella type rash. Y U 03/06/2001 03/08/2001 2 NONE PVT PVT NONE NONE Seasonal Allergies. 1
0167725 03/23/2001 TX 1.0 1 .0 M 03/01/2001 This patient had urticaria to the face, seen within 1 hour of reaction at the pediatric clinic. Y Y 02/21/2001 02/28/2001 7 PUB PUB Ceftin. PPD, SmithKline, lot # CO156AA, 02/21/01. Bilateral otitis media, bilateral conjunctivitis. 1
0167726 03/23/2001 CA 1.4 1 .4 F 03/21/2001 This child developed a fever, erythema and swelling developed on her left deltoid (6 x 7 cm) and a smaller area of erythema on the right deltoid. Y 03/19/2001 03/19/2001 0 NONE OTH PUB Augmentin Otitis media NONE 1
0167727 03/23/2001 OR 4.0 4 M 03/08/2001 This patient came into the health dept at 10:30 AM of immunization, no adverse reactions at the time of immunizations. The mother brought the child back to the health dept at 1:30 PM with systematic rash and welts. He was sent to the ER. Treated with Benadryl and sent home. Y Y 03/08/2001 03/08/2001 0 PUB PUB NONE OR200111 1
0167728 03/23/2001 OH 20.0 20 F 03/19/2001 3cm X 3cm redness with raised area at right upper arm. Area is warm to the touch. Pt denies any soreness, pain or discomfort. Y 03/15/2001 03/16/2001 1 OTH MIL NONE 1
0167729 03/23/2001 CA 31.0 31 M 03/14/2001 Left shoulder pain, post vax. Arthus reaction the next day on 11/21/00. Treated with heat and elevation. Y U 11/20/2000 11/21/2000 1 PVT PVT albuterol oral inhaler and insulin DM 1
0167730 03/23/2001 WA 53.0 53 F 03/21/2001 Rash, aching joints, especially knees, stiffness. Advised to treat with OTC NSAIDS such as ibuprofen or Aleve. Recheck in office if persists 4 weeks, post vax. On 3/21/01, improving. U 02/27/2001 03/13/2001 14 PVT PVT Trinalin, Nasacort, Atenolol, Premarin, Lodine, Lorazepam NONE HTN; Osteoarthritis 1
0167731 03/23/2001 MI 2.0 2 .1 M 2 hours, post vax, pt experienced seizure (shaking for 2 minutes) followed by decrease in level of consciousness. Taken to Pediatric ER at hospital. Review of systems were negative. Impression: Febrile seizure (pt was running 99F-100F) for several days. Given Motrin and released. Y Y 02/15/2001 02/15/2001 0 Neuro exam-WNL PVT PVT NONE Mild URI NONE 1
0167732 03/23/2001 OR 11.0 11 F 03/02/2001 On 1/24/01, pt developed flu-like symptoms of headache, stomachache, vomiting. Also complained of stomach pain on and off for the next 30 days. Vomiting lasted only 1 day. U 01/23/2001 01/24/2001 1 NONE PUB PUB Prilosec prn NONE "Nervous stomach" Rash~DTP (no brand name)~~6.00~In Patient OR200109 1
0167733 03/23/2001 OR 12.0 12 M 03/02/2001 Headache, 30 minutes, post vax. Had a headache and dizziness the next day. Fever of 102F on 2/21/01. Fever and headache continued until to 2/25/01. Mild swollen and sore throat and treated with antibiotic (Zithromax) but only took 4 days secondary to stomach pain. Y Y 02/20/2001 02/20/2001 0 Throat culture PUB PUB NONE NONE NONE OR200110 1
0167734 03/23/2001 NH 42.0 43 F 03/22/2001 On 3/14/01, used a 1" needle. On 3/15/01, had shooting pain down left arm when she raised it. Also has pain when she rotates arm. No redness or swelling. Applying cold compresses bid. I 600mg. U 03/14/2001 03/15/2001 1 NONE PVT PVT Herbal remedies NONE Chronic low back pain NH0111 1
0167735 03/23/2001 UT 4.0 1 .0 F 03/16/2001 Breakthrough case of varicella-spots, but no fever. Confirmed by doctor. No treatment. Y U 04/17/1997 03/12/2001 1425 PVT PVT NONE NONE NONE 1
0167736 03/23/2001 NY 20.0 20 M 03/07/2001 Pt complaining of swelling around the eyes, tightening of the throat and difficulty breathing, approx. 20 minutes, post vax. Pt also had redness in front of neck area that extended to behind ear lobes. Treated with 50mg Benadryl IM, 4 puffs albuterol inhaler and Epinephrine. Y Y 03/07/2001 03/07/2001 0 NONE MIL MIL NONE NONE 1
0167737 03/23/2001 AR 16.0 16 M 03/05/2001 Subjective fever, ears ringing, sore throat and neck "feels" swollen. Also have a decreased appetite and increased sleep. Y Y 02/26/2001 02/27/2001 1 PUB PUB NONE NONE AR0116 1
0167739 03/23/2001 AK 15.0 15 M 03/15/2001 3 hours, post vax, felt tired, stomach and tongue burned. Mother brought him to the clinic on 3/12/01 and to ER at hospital. ER to him to "take it easy". Pepto-Bismol helping with stomach. New tooth brush may have bothered tongue; recovering. Doctor told mom "a viral infection too soon for vaccine reaction". Y Y 03/12/2001 03/12/2001 0 NONE PUB UNK BP increased, skin clammy but had been warm Allergy to PCN and Pediazole AK200122 1
0167740 03/23/2001 VA 58.0 58 M 03/15/2001 Received yellow fever and Hep-A on 3/12/01. About 19:00, felt very tired and went to bed. Woke up with vomiting, weakness, headache and metallic taste. No specific Rx taken. Felt improved but weak on 3/13/01. Y 03/12/2001 03/12/2001 0 NONE PVT PVT Many-get from pt NONE Get from pt or LMD 1
0167741 03/23/2001 OK U Redness extending from the injection site in the left deltoid down to the elbow on lateral side of upper arm. Lump 68mm in diameter and warm to touch. U 03/15/2001 03/15/2001 0 MIL MIL Amoxicillin NONE NONE Reaction unevaluable~Td Adsorbed (no brand name)~1~41.00~In Patient 1
0167742 03/23/2001 PA 3 M 03/16/2001 Mom called 3/16/01 and stated child has temperature 101F and broke out with chickenpox with about 15, total. Y 02/26/1996 03/16/2001 1845 NONE PVT PVT NONE NONE NONE 1
0167743 03/23/2001 PA 7.0 7 M 03/16/2001 Mom called on 3/14/01 and stated child broke out with chickenpox, about 15 total. Y 03/14/2001 03/14/2001 0 NONE PVT PVT NONE NONE NONE 1
0167744 03/23/2001 MA 5.0 U Chickenpox (mild case) in a healthy vaccinated child, aged 5.8. Y 04/18/1996 03/17/2001 1794 NONE PVT PVT NONE NONE 1
0167745 03/23/2001 NC 0.3 0 .3 F 03/12/2001 When awake the pt experienced high pitch crying. Pt would go to sleep but at times cried up to 30 minutes non-stop. Unsure if accompanied by fever due to treatment with Tylenol around the clock. Y 03/05/2001 03/05/2001 0 NONE PUB OTH NC01033 1
0167753 03/26/2001 MA M 03/21/2001 A physician reported that an adult male in his late 30's received an injection of Flu-Sheild (1999-2000 formula) in the fall of 1999. Within 1 week post-immunization, he developed cryoglobulinemia and vasculitis. He was hospitalized. Unspecified tissue biopsies are pending. No further information was available at the date of this report. Y U Unspecified tissue biopsies-pending OTH OTH UNK UNK UNK HQ8678121MAR2001 1
0167754 03/26/2001 1.08 M 03/22/2001 A mother reported that her 13 month old son received an injection of Prevnar. Three weeks, post vax, he developed erythema multiforme. He was hospitalized. No further information was available at the date of this report. Y U UNK OTH OTH UNK UNK UNK HQ8671221MAR2001 1
0167757 03/26/2001 CO 0.2 0 .2 M 03/09/2001 Approximately 5 hours after receiving his 2 month immunizations, the patient woke up from a nap crying. Assuming he was hungry the mother tried to breast feed him, but he wouldn't eat. He appeared to be going back to sleep and then she noticed his coloring changed to a bluish / green / gray color, his body went limp and it appeared that he was not breathing. She called 911, within about 1 minute after giving him a couple of breaths and tickling his feet, he became conscious again, but was lethargic and pale. He was admitted into the hospital that night. Several tests were done. Y Y 3 Y 01/12/2001 01/12/2001 0 Tests were done for any viral or bacterial infections (see hospital records) PUB PUB NONE NONE NONE 1
0167758 03/26/2001 OH 3.9 3 F 01/04/2001 Incident was called to the health dept several days after the incident. The nurse who took the call did not initiate a report and has since left the health dept. VAERS form initiated on 1/4/01. Per doc no. 215040, 60 day follow-up, she uses "gait training walker". Y Y Y Y N 05/07/1998 05/07/1998 0 UNK PUB PUB NONE OH0010 1
0167759 03/26/2001 PA 1.25 1 .3 M 03/03/2001 Post vax, on the same day and into the next day, pt had redness at injection site or right arm and left arm, fast heart rate and pale in color. He had increased temperature. He couldn't sleep. Rash appeared around trunk area on 1/2/01 through 1/4/01. A seizure occurred on 1/8/01. He was listed as serious and in ICU. Will be on Tegretol for a few years for febrile seizure disorder. Y Y 2 Y 12/18/2000 12/18/2000 0 EEG; CT Scan; LP; Blood and Urine tests PVT PVT NONE 1
0167760 03/26/2001 TN 19.0 19 M 03/05/2001 This client started scratching his right upper arm at the site of the injection within 5 minutes. An ice pack was applied. Call to the doctor was made. Benadryl was given. At 2:30 PM his BP 136/70, 2:45 PM BP126/80. He had urticaria on his chest arms, and back, with itchiness, a runny nose, no sob or wheezing. Benadryl was given again. Epinephrine was given. The patient was observed for 35 minutes. The rash subsided, and the runny nose stopped. No sob or wheezing. Medrol dose pack given and sent home with the client. Instructed to take Benadryl. Y Y Y 03/02/2001 03/02/2001 0 PUB PUB Sudafed the day before Allergy to PCN TN01011 1
0167762 03/26/2001 CA 1.5 0 .7 M 04/02/2001 Information has been received from a physician concerning an 18 month old male who on 02/13/01 was vaccinated with a second dose of Hepatitis A virus vaccine inactivated. On 02/23/01, the patient developed jaundice and increased bilirubin. Upon internal review the patient's experience was determined to be an Other Important Medical Event. It was noted that the patients first dose of Hepatitis A virus vaccine inactivated was administered on 05/18/00. Additional information has been requested. F/U On 3/8/01 the direct bilirubin was 2.9 and total bilirubin was 4.2. the pt had no other signs of viral infection. One week post vaccination he had abnormal labs. The pt continued to deteriorate and was seen in the transplant center 2 weeks ago and may possibly end up being transplanted. She added that the vaccine was given early to protect her son against hepatitis A. The physicians felt the jaundice and hyperbilirubinemia was caused by the hepatitis A vaccine. She also reported there was not explanation for his condition and she thinks that chances are his condition is not related in the vaccine since it is an inactivated vaccine. F/U another physician reported that the child did have a decreased WBC after the 1st dose of vaccine and he wondered if the viral stimulation irritated the liver. The pt was on therapy with Bactrim at the time of the decreased WBC count and he was not sure if the decreases in WBC was secondary to the Bactrim.The physician did not feel there was an association with the vaccine and the events but he did not know. A 15-day follow up report received 8/14/2003 adds: Info has been received from a physician concerning her 18 month old son born with biliary atresia who had surgery to correct the atresia at 3 weeks of age. Baseline levels of direct bilirubin was 0.3 and total bilirubin was 0.5. On 05/18/2000 the pt was vaccinated with hepatitis A virus vaccine inactivated (lot 632987/1753J). After the vaccination in May the pt's platelet and WBC count decreased. On 02/13/2001 the pt was vaccinated with a 2nd dose of hepatitis A virus vaccine inactivated (lot 637626/1645K) in the right deltoid. On 02/23/2001 the pt developed jaundice and increased bilirubin. Upon internal review the pt's experience was determined to be an Other Important Medical Event. On 03/08/2001 the direct bilirubin was 2.9 and total bilirubin was 4.2. The pt had not other signs of viral infection. One week post vaccination he had moderate viral count, elevated bilirubin, elevated WBC count and elevated alkaline phosphatase. The pt continued to deteriorate and was seen in the transplant center 2 weeks ago and may possibly end up being transplanted. The reporting physician added that the vaccine was given early to protect her son against hepatitis A. The physician initially felt the jaundice and hyperbilirubinemia was caused by the hepatitis A vaccine. She also reported that there was no explanation for his condition and she thinks that chances are his condition is not related to the vaccine, since it is an inactivated vaccine. Another physician, the pediatrician caring for the pt, reported that the child was born with biliary atresia and since it is a progressive disorder, it was known that the child would eventually require a liver transplant. The physician stated that the child's LFT's and bilirubin have varied over the course of his life but have not been normal. The child did have a decreased WBC after the 1st dose of vaccine and the physician wondered if the viral stimulation irritated the liver. The pt was on therapy with sulfamethoxazole (+) trimethoprim (Bactrium) at the time of the decreased WBC count and he was not sure if the decrease in WBC was secondary to the sulfamethoxazole (+) trimethoprim (Bactrim). The child's LFT's at that time did not increase. The physician did not feel there was an association with the vaccine and the events but he did not know. Additional info from the physician indicated that the child developed increased bili and liver enzymes approx 3 weeks (previously reported as one week post vaccination) after hepatitis A virus vaccine inactivated given on 02/13/2001. The pt was diagnosed with mononucleosis with unilateral laterothoracic exanthem. The physician noted that at this time he does not associate this event with the hepatitis A virus vaccine inactivated. The pt subsequently recovered from the event. No further details were provided. This is an amended report. The pediatrician's discussion of the liver transplant and LFT info has been added. Additional info received 8/12/03 from the pediatrician caring for the pt indicated the child is doing surprisingly well, and has been relatively stable for some time. The child has had a benign course without an increased frequency of infections. The physician reported that the pt's liver function tests were elevated but are stable for this pt. The pt's jaundice is not severe and his bilirubin levels have also remained slightly elevated, but are also stable for him. The physician indicated that the pt had been a candidate for a liver transplant because of his biliary atresia and that he is on the liver transplant list. No further info is available. Y N 05/18/2000 Total serum bilirubin-increased, elevated WBCcount and elevated alkaline phosphatose. OTH OTH UNK Biliary atresia (born with this) WAES01031016 1
0167764 03/26/2001 WA 1 .5 F 03/19/2001 Information has been received from a relative concerning a female child with the history of vaccination with Haemophilus B conjugate vaccine who on 02/097/00 was vaccinated with MMR. Additional vaccination on 08/28/00 included Hepatitis A vaccine and Varicella virus vaccine live. The reporter noted that the patient has been slow to develop. The child did not sit up until 11 months of age. She did not crawl until 16 months of age. The child did not walk until she was 2 years of age. In January or February of 2001 the patient experienced a febrile seizure. A brain scan revealed that the patient was affected by "flashing lights." It was noted that as of 03/07/01 the child still could not talk. Upon internal review, slow to develop and febrile seizure, were determined to be Other Medical Events. Additional information has been requested. F/U info rec'd indicated that the pt was seen in the ER on 1/9/01 and had a follow up visit at the office on 2/22/01 for an ear recheck and was to return in 3-4 wks for another ear recheck. She stated that there was no documentation at that visit of a developmental disorder. Upon internal review, slow to develop and febrile seizuree, were determined to be Other Medical Events. Follow up on 06/29/2001: "Lot number for vaccine #2 is not provided, Lot # for vaccine #3 is: 638804/0561K." U 02/09/2000 01/01/2001 327 Head Computed Axial - affected by flashing lights. UNK UNK Developmental disorder WAES01030817 1
0167768 03/26/2001 NY 29.0 29 F 03/13/2001 In January 1996 - the patient had visual disturbances of the left eye, resolved on it's own. In Sept & Oct. of 1996 - the patient had leg numbness, feelings of "pins & needles"; resolved after 4 months. In March 2000 - The patient's left eye, same visual disturbance, optic neuritis, MS. High dose of steroids, MRI, Copaxine. Follow up received on 5/21/01 states, "she has headaches which are mostly eye strain, muscle tension headaches. No dizziness, loss of consciousness, trouble with speech or memory. No nausea, vomiting, loss of taste or smell sensation. She still has poor vision in the left eye with difficulty identifying shapea, figures, colors. She is also very photosensitive in this eye. No diplopia. No facial numbness or tingling. No difficulty chewing or swallowing. No hearing loss, tinnitus or vertigo. No lateralzing weakness. She has mild numbness on the medial side of her left foot, which is intermittent. No other sensory symptoms. No difficulty with balance, coordination or gait. No sphincteric inconstinence. No history of head, neck or low back injury. No cardiopulmonary, gastrointestinal or genitourinary symptoms. Negative for mitral valve prolapse, rheumatic fever, coronary artery disease, cardiac arrhythmias, hypertension, COPD, asthma, anemia, diabetes, thyroid, liver or renal disease. No hitory for migraines, seizures or strokes. Impression: mild early stage of multiple sclerosis. History of optic neuritic twice in teh elft eye. Clinically stable. Currently eight months pregnant. After she delivers and finished nursing, she can start the Copaxone 20mg subq qd. I will see her back in follow-up in six months or earlier if needed." Follow up received on 5/21/01 states "pt was seen for neuro-ophthalmic evaluation on 3/16/00 at your request. This young woman has a history that dates back approximately two years when she had her first episode of visual loss in the left eye. At that time, she stated that she had a gradual onset of visual loss over a month that was painless and had no pain in eye movement according to her. I do not know if she sought medical attention, but she certainly did not get any treatment and had no workup for this. She stated her vision; however, eventually improved. It probably went back to normal. Sometime after that, and I am not sure exactly when, whether it was soon after or months afterwards, she experiecned numbness in the anterior and posterior bilateral thighs. She and others, she said, attributed the numbness to a vigorous exercise program. It, however, resolved after two months. She has not had any other common neurological problems until January of 2000 when she began to experience a gradual visual loss in the left eye over three weeks. She had pain in eye movement. When you saw her, your note states she was 20/25 in that eye with only slight temporal pallor. Her vision hasa now worsened over the last day to no light perception. No family history of any significant neurological problems according to her. On today's evaluation, she is 20/15 OD and no light perception OS. She has a normal threshold field in the right eye and normal anterior segment exam. Intraocular pressure are 15 in both eyes. There is no ptosis nor proptosis. No inject ? the conjunctivae and sclerae. The pupils are 6mm, round and reactive to light with an amaurotic pupil in the left eye. Examination of the extraocular eye muscles revealed full versions, smooth pursuit without nystagmus and rapid saccades. Funduscopy of the right eye demonstrates a ? disc, macular, retina, and vessels with 0.2 cupsl The left eye? light disc with severe diffuse loss of nerve fiber later, intact macula, retina and vessels. Neurologically, she has an intact mental status. Her cranial nerves are really otherwise normal. Her gait and tandem are normal. Her tanem stance with her eyes closed is normal for 30 seconds. Rapid finger movements, finger-to-finger-to-nose testing, and upper extremity strenght are normal. Reflexes are 1-2+ in the uper and lower extremities, and the toes are downgoing. The Romberg is negative. Vibration sensation in the toes is normal. This is an unusual presentation of recurent optic neuropathy. It sounds like in her age group an optic neuritis. I say this because I believe that episode of numbness that she had in the upper legs was not, of course, a nerve root or local muscle problem but an episode of demyelinating disease probably of the spinal cord. Because of this, she has had an MRI ordered otday with the suspicion that she has optic neuritis recurrent and MS. I am bothered by the fact that, however, the first episode did not have pain in eye movement, and she said it was a gradual loss over the course of four weeks which is a little bit atypical but again, we have no documentation of this. In any event, an MRI scan was ordered, and, indeed, she has multiple brain UBOs on FLAIR and T2-weighted images, and she has slight but definite enhancement of the intracanalicular portion of the optic nerve with gadolinium. I have discussed these issues with her and her husband and she is set up for homecare IV for three days followed by a week or tend ays or oral prednisone. I think that she will be a good candidate to place on Avonex because, indeed, I do believe she has MS." Y N 12/15/1995 03/13/2000 1550 MRI - performed 03/00. OTH PVT Prenatal vitamins NONE Tonsillectomy 1978, cholecystectomy in 1995; Compazine-causes paresthesias 1
0167769 03/26/2001 CA 0.4 0 .4 M 03/07/2001 Hives, 5 hours, post vax, on 2/20/01. Child was in no acute distress and responded to Benadryl IM with resolution of hives, within 1 hour. Pt will be referred to allergist before further IZ's. Y Y 02/20/2001 02/20/2001 0 NONE PUB PUB Topical steroid creams Atopic dermatitis CA010022 1
0167770 03/26/2001 NY 1.0 0 1 F 03/12/2001 9 hours, post vax, temperature rose to 104F, had heavy breathing and a rash all over her body by the 2nd day. Y Y 03/07/2001 03/07/2001 0 UNK UNK NONE NONE NONE 1
0167771 03/26/2001 TN 0.4 0 .5 M 12/05/2000 Child was immunized on 12/1/00. Fever started on 12/2/00 at 102.8F followed by diarrhea. On 12/4/00, child broke out in a raised, red rash all over his body. Encouraged mom to take child to PMD for evaluation. On 12/7/00, spoke with parent and stated child was taken to ER and dx'd with Roseola. On 2/9/01, spoke with child's father at work who states the child has completely recovered, has no rash or other problems from this reported incident. U 12/01/2000 12/02/2000 1 UNK PUB PUB NONE NONE History of heart murmur and arteriole defect TN01008 1
0167772 03/26/2001 PA 16.0 15 M 03/06/2001 Onset of pain at injection site of right arm followed by redness and fever and problems for 1 to 2 weeks. Y 12/31/2000 01/01/2001 1 NONE PVT PVT NONE Asthma history and rhinitis 1
0167773 03/26/2001 DE 3.0 3 M 03/09/2001 On 3/7/01, phone contact from caregiver; she reports child has a local reaction to the vaccine in left arm. Has an area of redness and induration somewhat larger than a quarter, child complaining of soreness, there is no fever. Reports active movement of arm but is fussy if the arm is touched. No loss of appetite. Told to use Tylenol every 4 hours and apply cold pack to site. Family to return to clinic on 3/8/01 for PPD reading. On 3/8/01, arm was checked and left deltoid still swollen and red. Redness extends about midway of the arm but not swollen down the arm. Area is still sore. On 3/9/01, called and spoke to grandmother who is his caretaker during the day. She reports that he is much better today. Arm is not sore and the redness is going away. Activities are normal. Y 03/06/2001 03/06/2001 0 PUB PUB PPD/LFA NONE Allergies to ham which causes hives and also PCN which causes hives. 1
0167774 03/26/2001 FL 0.5 0 .3 F 03/16/2001 High-pitched cry past 2nd DPT. Y 01/12/2001 01/13/2001 1 NONE PVT PVT NONE NONE NONE 1
0167775 03/26/2001 CA 1.4 1 .3 M 03/05/2001 Rash behind his neck appeared the day after and lasted 3 weeks. Slight fever the night of and lasted 2 days at 101F. Given children's Tylenol to relieve pain and fever twice. Y 02/14/2001 02/14/2001 0 NONE PUB OTH NONE NONE 1
0167776 03/26/2001 WI 0.7 0 .7 F 03/16/2001 On 2/9/01, around midnight, mom heard baby cry out. She went to check on her and extremities limp, blue lips for approx. 1 minute in duration. She called 911. When they arrived, pt was ok. No follow-up. Reported to us on 3/13/01. Y 02/08/2001 02/09/2001 1 NONE PVT OTH NONE NONE 32 week premature twin. 1
0167777 03/26/2001 CA 0.3 0 .3 F 03/16/2001 2 days, post vax, noted at left anterior thigh a 5mm area of redness and induration without warmth. Also, with faint light red petechial rash distal to puncture site to level of knee only involving anterior aspect of thigh. No associated perfusion problems or generalized edema of this lower extremity. Y 03/14/2001 03/16/2001 2 NONE PVT PVT NONE NONE NONE 1
0167778 03/26/2001 MN 1.25 1 .3 F 03/19/2001 Localized reaction to DTAP/Hib in left thigh with a 3" diameter erythema, surrounding injection site, slight swelling, slight warmth and firm. Y 03/15/2001 03/16/2001 1 PVT UNK NONE NONE NONE 1
0167779 03/26/2001 AL 1.3 1 .3 M 03/23/2001 On 3/22/01, post vax, had a small knot at injection site. On 3/23/2001 AM, had red, swollen, hard area, warm to touch about 10cm X 5.5CM on left upper thigh area. Ice pack to area and Benadryl every 6 hours. Y 03/22/2001 03/23/2001 1 NONE PVT PUB Suprax, Floxin Resolving right OM 1
0167780 03/26/2001 NY 0.5 0 .5 F 03/16/2001 Pt seen in ER that night to rule out seizure but all tests for seizure were negative. Y Y 03/01/2001 03/01/2001 0 EEG; Cat Scan PVT OTH NONE URI NONE 1
0167781 03/26/2001 MI 0.5 0 .5 M 01/12/2001 Pt had a fever up to 104F within 24 hours of Prevnar vax. Y 01/09/2001 01/09/2001 0 NONE PVT PVT NONE NONE NONE 1
0167782 03/26/2001 MD 0.3 0 .3 F 02/23/2001 At 4 months, child noted to be "grayish; unresponsive and limp" for about 1 1/2 to 2 minutes, post vax, earlier that day (about 3-5 hours). Y Y 02/23/2001 02/23/2001 0 EKG-nml MIL MIL Amox. prescribed, not taken by time of incident Otitis Media NONE 1
0167783 03/26/2001 MD 0.75 0 .8 M 03/26/2001 Allergic reaction consisting of rash (non-urticarial). Post Prevnar, had maculo-papular rash occurring less than 24 hours. Treated with hydroxyzine. U 03/13/2001 03/14/2001 1 NONE OTH PUB Diarrhea NONE 1
0167784 03/26/2001 NY 2.0 2 .1 F 03/12/2001 Mother brought child into office with fever of 105.3F (ax). Child was alert but very irritable. Mom had given Tylenol at home without relief. Motrin elixir was given in office with relief. Temperature went down to 100.7F (ax) after 40 minutes, post Motrin dose given. Y Y 03/05/2001 03/06/2001 1 NONE PVT PUB NONE NONE NONE 1
0167785 03/26/2001 36.0 34 M 03/09/2001 Generalized itching, hives over entire body, swollen eyes, lightheaded and dizzy, SOB on (2 separate events). Y Y 11/30/1999 03/01/2000 92 MIL MIL 1
0167786 03/26/2001 PA 54.0 52 M 03/09/2001 Continuous joint pain, pain at injection site; possible cause of elevated liver function. U 04/23/1999 05/21/1999 28 Lab-elevated liver function PVT PVT Vasotec High BP High BP 1
0167787 03/26/2001 PA 53.0 51 F 03/17/2001 Pain in arm at injection site for probably 2 weeks, post vax. Chest pain after booster injection and some joint pains. Y Y 04/23/1999 04/24/1999 1 CXR; EKG; Stress Test; Lab done 4/00 PVT PVT NONE NONE 1
0167788 03/26/2001 UT 26.0 26 F 12/20/2000 12/15/00 at 17:30, left arm was immovable, soreness and aching "muscle pull type pain". Under left arm was tender. Started running a fever, chilling (significant) at 23:00. On awakening on 12/16/00 AM, continued with sore arm, felt warm with fever, shaky, "tingly all over inside", chills again at 20:00, lasting all night. Sunday AM, took temperature and it was 102.9F (ear). Took Tylenol and Advil and fever decreased. Saw MD on 12/17/00 and started on prednisone. Y Y 12/15/2000 12/15/2000 0 NONE PUB PUB Methylprednisolone started after 12/20/00 NONE NONE UT002729 1
0167789 03/26/2001 SC 60.0 60 F 03/19/2001 Hives treated with prednisone 10mg Tabs/took 2 (48) packs before the hives were completely gone. First round of medicine did not rid pt of hives. Y 11/29/2000 12/02/2000 3 PUB PVT NONE NONE 1
0167790 03/26/2001 CA 52.0 51 F 03/09/2001 Per pt, "developed cellulitis of the right deltoid area; 2 days, post vax. Was placed on 2 antibiotics (Keflex and Biaxin) and Prednisone, per pt. Y Y 02/13/2001 02/15/2001 2 PUB OTH UNK NONE NONE 1
0167791 03/26/2001 NY 12.0 12 F 03/22/2001 Broke out in hives, post vax. No breathing problems. Recommended OTC Benadryl and call office if any other problems. This was vaccine #3. Y 03/19/2001 03/19/2001 0 NONE PVT PVT NONE NONE NONE 1
0167792 03/26/2001 VA 1.5 1 .5 F 03/16/2001 Y Y 03/14/2001 03/15/2001 1 PVT PVT NONE NONE Swelling and erythema~Pneumo (Prevnar)~4~1.25~In Patient 1
0167793 03/26/2001 OR 13.0 13 F 02/23/2001 Localized site reaction noted on 2/22/01. Left arm with 2cm reddish, warm, and tender area. Denies itching or fever. No evidence of breathing difficulty at this time and denies ever having any. Full ROM. Treatment: Benadryl prn. Y U 02/08/2001 02/22/2001 14 PUB PUB NONE NONE OR200106 1
0167794 03/26/2001 PA 2.0 2 .4 F 03/19/2001 No text reported Y Y 02/14/1997 03/17/2001 1492 NONE PVT PVT NONE NONE NONE 1
0167795 03/26/2001 PA 5.0 1 .3 M 03/19/2001 Mom called on 3/15/01 and states that child broke out with chickenpox. Y Y 02/14/1997 03/15/2001 1490 NONE PVT PVT NONE NONE NONE 1
0167796 03/26/2001 SD 43.0 43 M Shot was given on 06/12/00 at 8:30 AM and reports within 1 1/2 hours, the patient became hoarse and this lasted 1 hour. He denies any other problems, no rash. Telephone call to MD and told to give shot and observe. Telephone call to client on 07/19/00 at 12:00. Client reports no problems. Y 06/12/2000 06/12/2000 0 PUB PUB NONE NONE NONE SD00006 1
0167797 03/26/2001 NY M 02/22/2001 This patient had edema of the face, fever, chills, headache, fatigue, and a sore throat. 11/20/2000 UNK UNK 1
0167798 03/26/2001 CA 63.0 M 02/01/2001 Within 12 hours, the site was painful, toxic reaction. Within 15 hours, prostration incapacitated. The patient had tense induration, left deltoid vaccination site, fever. 48 hours after vaccination, Lymphamgenic streaking, pain, clear cellulitis ; requiring antibiotics. The pain lasted for 6 weeks. Induration (fat necrosis) golf ball size x 90 day. U 10/23/2000 UNK UNK Allergy to Sulfa. Post infection arthritis. 1
0167799 03/26/2001 NY 48.0 48 F 02/22/2001 The left deltoid site of injection, had severe pain with throbbing. Tingling on the surface of the left hand. U 12/07/2000 12/07/2000 0 UNK UNK 1
0167800 03/26/2001 NY 25.0 25 F 02/22/2001 This patient had erythematous edema at the site of the injection; left deltoid. U 11/28/2000 12/01/2000 3 UNK UNK 1
0167801 03/26/2001 NC 4.0 4 F This patient had edema, erythema, and pain at the site of the injection. Erythema > 5cm diameter. Three patients who had the same lot # DTaP had this problem. Y Y 02/06/2001 02/08/2001 2 PVT PUB NC01027 1
0167802 03/26/2001 OR 77.0 77 F This patient had swelling, and redness of the left arm from above the elbow to the wrist. Y U 02/28/2001 03/01/2001 1 PVT PVT NONE NONE NONE 1
0167804 03/26/2001 IL 2.0 2 .7 M 03/08/2001 This patient had swelling of the right anterior thigh, tenderness within 24 hours. Still present 48 hours post vaccination, no fever. Y Y 03/06/2001 03/07/2001 1 NONE PUB PUB NONE NONE NONE 1
0167805 03/26/2001 AK 50.0 50 F 02/05/2001 This patient's left arm became sore and very swollen, her fingers were very numb and painful, and she had a headache. She was seen by ER physician on 02/05/01. At that time she reported her last TD was 4 years ago. Prescribed Motrin for the pain, and ice to the affected arm. Y Y 02/02/2001 02/03/2001 1 PVT PVT 1
0167806 03/26/2001 SC 53.0 53 F 02/13/2001 Had no cold-like symptoms the day of immunization but 24 hours later, had chills and hot flashes (did not take temperature); had productive cough with blood tinged and sinusitis, head congestion but did not see MD. Taking herbal remedy and aspirin. Y 02/08/2001 02/09/2001 1 OTH PVT NONE NONE Recurrent yeast infection, currently following herbal guidelines to delete all yeast from body. Unspecified reaction~Typhoid Vi Polysaccharide (no brand name)~~0.00~In Patient SC0106 1
0167807 03/26/2001 WA 30.0 30 F 02/22/2001 Started to ache all over body and back and legs. Lungs feel congested; some shortness of breath and was advised to go to ER immediately or call 911. At 10:15, pharmacy called, not usual adverse reaction. 24 hours adverse effect called in ER. No long term effects. Given pain Rx of Darvacet. Y Y 02/20/2001 02/21/2001 1 OTH UNK NONE 1
0167808 03/26/2001 OR 11.0 11 F 03/02/2001 Had second Hep-B shot on 2/20/01. On 2/27/01, 2/28/01 and 3/01/01, had stomachache and vomiting. Also, had stomachache and vomiting after the 1st Hep-B on 1/24/01 with gradual improvement in stomach pain over 30 days. Referred to MD on 3/2/01 and he believes it is not related to the Hep-B series. Other children in the family, later, had the same flu-like symptoms who were not vaccinated. Y U 02/26/2001 02/27/2001 1 UNK PUB PUB Prilosec prn Mild stomach ache "Nervous stomach" Rash~DTP (no brand name)~~6.00~In Patient|~Vaccine not specified (no brand name)~~3.00~In Sibling OR200108 1
0167809 03/26/2001 WA 32.0 F 03/14/2001 8 days, post vax, developed sore throat swollen, nodes in neck, joint pain especially in legs, achy, fever which lasted 2 days. No SOB. Y NONE MIL UNK NONE NONE NONE 1
0167810 03/26/2001 CA 75.0 F 03/07/2001 Have noted approx. 5 separate local injection site redness, inflammation, swelling of suspected DTH reaction at injection site with pneumococcal vaccine. All spontaneously resolved. 01/01/2001 03/05/2001 63 UNK UNK 1
0167811 03/26/2001 PA 8.0 5 M 03/14/2001 Mom called on 3/14/01 and stated child broke out with chickenpox, on axilla area, head, arms and legs; 12 to 15. Y 09/14/1997 03/13/2001 1276 PVT PVT NONE NONE NONE 1
0167812 03/26/2001 NC 53.0 53 F 03/22/2001 Subsequent to receiving vax the pt came to office complaining of arthralgia. Pt states that 1 week post vax, she began to have some hard masses around her ears, then developed throughout the next couple of days some aches and pains in her knees and hands, along with swelling. Pt denies rash. Y 01/26/2001 02/02/2001 7 NONE OTH OTH sinus medicine history of fibromyalgia chronic sinusitis; fibromyalgia 1
0167813 03/26/2001 MN 8.0 8 F 02/22/2001 Pt developed tiny vesicles or papular erythematous base - mild yet - few on face, ear, chest, mild abdomen. Y Y 10/15/1999 11/02/1999 18 NONE PUB PUB Septra TT BID x 7D UTI 1
0167814 03/26/2001 UT 1.59 1 .6 M 02/14/2001 Pt developed varicella despite vaccine. Vax given at Dr. office - No clinical data. U 06/28/1999 02/13/2001 596 PVT PVT 1
0167815 03/26/2001 PA 32.0 32 F 03/14/2001 On 3/12/01 pt called to report that she was having a lot of pain and soreness in her right arm. She received TD and MMR on 2/8/01. Instructed to take an OTC pain reliever of her choice (no ASA) and compress the area as a comfort measure. If no relief, she should call her family doctor. On 3/14/01, pt called to report family doctor refused to see her. Is taking ibuprofen for pain. Pain from shoulder to fingers for several days, per pt report. Is able to move arm with effort. Directed her to call doctor and explain that our facility is not set up to treat-is a free standing IZ site. Pt was seen by a PA at hospital minor treatment center on 3/15/01 at 09:15. PA feels it may be an inflammation of the bursa and will start her on Anaprox this evening. If no better in 3-4 days, she is to follow-up with her family doctor. Y U 03/08/2001 03/08/2001 0 PUB PUB Birth control pills NONE NONE 1
0167816 03/26/2001 MD 50.0 F 03/09/2001 50 year old woman received TD and developed chills, sore arm and limited range of motion, 2 days later. She used Tylenol for pain. 2 days later, she sought medical evaluation and a 13cm X 9cm area of erythema, tenderness and swelling was noted although she was feeling better overall. U 03/05/2001 03/06/2001 1 UNK UNK Thiacide, Premarin Hypertension 1
0167817 03/26/2001 PA 61.0 61 M 03/16/2001 Had soreness at site of 1st one, 1 month, post vax, no redness or swelling or heat. Had local swelling, redness, soreness, systemic headache, increased temperature, aching all over and joint pains after 2nd one. Follow up information received 06/15/2001: Continues to have pain at injection site. Radiates up into neck and shoulder. When site is palpated, cause pain in other shoulder. No redness, swelling, hardness or heat noted at site. Y U 03/14/2001 03/16/2001 2 NONE OTH PVT ASA, Actose NONE Allergy to PCN (causes rash); Diabetes Injection site pain~Hep B (Engerix-B)~2~51.00~In Patient 1
0167818 03/26/2001 WV 33.0 33 F 03/15/2001 At first pt felt weird, became weak, shaking, cold sweat, threw up, blood pressure bottomed out, shallow breathing, itching, dry mouth, tired and dizzy. Symptoms started approximately 15 minutes post vax, was made to sit in clinic until strong enough to go down the hall and out to ER. There pt was treated with epinephrine and Benadryl. The next day the pt experienced tiredness and dry mouth. Y Y 02/20/2001 02/20/2001 0 Neg Omm PUB OTH NONE NONE 1
0167819 03/26/2001 VA 10.0 10 F 01/15/2001 Pt experienced shaking, leg weakness, lightheadedness, face flushing/reddening. Symptoms lasted approximately 2 hours. Y 01/03/2001 01/03/2001 0 NONE PVT PVT NONE NONE 1
0167820 03/26/2001 NV 4.0 4 M 03/16/2001 Rash on chest, face and legs. Puffiness around eyelids. Went to urgent care for evaluation and treated with po Benadryl and Tylenol. Y Y 03/15/2001 03/15/2001 0 NONE PUB PUB NONE Runny nose, cough but no fever. NONE 1
0167821 03/26/2001 GA 2.0 F 03/16/2001 Pt had about 4 1/2cm diameter of erythematous, indurated area on left thigh surrounding site of injection. No heat, tenderness, changes in gait or fever. Treated with Benadryl. Y U NONE PVT PUB NONE NONE 1
0167822 03/26/2001 WA 60.0 60 M 03/17/2001 Pt experienced a very sore upper arm for about 2 weeks. During the last week in February, very sore in area 2 to 3 inches above solar plexus. Y 01/22/2001 02/16/2001 25 NONE PUB PVT Dapsome; Clamipramine NONE sulfa allergy diagnosed in mid 1940's 1
0167823 03/26/2001 NJ 32.0 32 F 03/15/2001 Pain, swelling and redness 14 hours, post vax, followed by chills, fever and bad malaise on the next day. Symptoms started to resolve on the 3rd day. Y 03/16/2001 03/16/2001 0 NONE PUB PUB NONE NONE NONE 1
0167824 03/26/2001 OH 5.0 5 M 03/19/2001 Mom called on 3/5/01 and reported that on 3/2/01, the pt's right leg became very red and extremely swollen and bruised with a rash from knee to top of thigh. It was very tender to touch and unable to walk on leg. Also, had fever of 102.5F until 3/4/01. Treated with Benadryl po and Tylenol. Y 03/01/2001 03/02/2001 1 NONE PVT PUB NONE NONE Bronchitis, sinusitis in the past. 1
0167825 03/26/2001 OH 5.0 5 M 03/19/2001 Mom called on 3/19/01 to report reaction. On 3/16/01, entire right arm was swollen, red and warm. Did have fever any on 3/15/01. Was taken to ER and treated with Benadryl every 6 hours and steroid burst. Y Y 03/14/2001 03/15/2001 1 NONE PVT PVT NONE NONE Did react with hives to tourniquet when had surgery in 8/96 1
0167826 03/26/2001 KS 38.0 38 F 03/13/2001 Prominent local injection site reaction with diffuse full body rash, fever up to 104F, headache and myalgias. All present, 1 week, post vax, improved and then recurred 2-3 weeks after. Rx'd with Benadryl, steroids. Local reaction and rash still present, 4 weeks out. Follow up: Unfortunately, this was a mass immunization int he military, and with further research I still could not locate any lot #'s. Y 02/16/2001 02/22/2001 6 MIL MIL 1
0167827 03/26/2001 CA 1.08 2 .0 M Hives on face, neck, chest and injection sites, 10-15 minutes, post vax, were given. Diphenhydramine was given IM. No respiratory distress was observed. Hives resolved in 5 to 10 minutes, after antihistamine was given. Appt. and seen in urgent care pediatrics and was discharged home by MD with Atarax. Follow-up done. Y Y 02/23/2001 02/23/2001 0 NONE PUB PUB PPD/Aventis Pasteur/U0405AA/LFA/0 previously NONE NONE CA010021 1
0167828 03/26/2001 NY 1.75 1 .8 F 03/19/2001 Site of DTAP became red, raised and discolored the day after immunization was given. Had office visit on 3/14/01 and was given Keflex for cellulitis of leg. Developed blisters on 3/15/01 and had a recheck office call on 3/15/01. Is improving. Y Y 03/12/2001 03/13/2001 1 PVT OTH Amoxicillin x 10 days and was still being given on day of vaccinations. ROM-resolving 1
0167829 03/26/2001 OH 0.3 0 .4 M 03/12/2001 Began crying approx. on the 5th day, post vax. Cried at long intervals and had short naps between. Saw doctor the next AM of 1/4/01 and fever of up to 103F the day of shots and the next day. Ran a low-grade temperature for a couple more days. Cried for approx. 3 days, at long intervals, then for 2 days to a lesser degree. Cry was high pitched, as if in pain. Not a regular cry. No redness, swelling or hardness at injection site. Y Y 01/03/2001 01/03/2001 0 NONE PUB PUB NONE NONE Closed spina bifida; scoliosis; fused discs in lower spine. OH0008 1
0167830 03/26/2001 OH 1.08 1 .1 M 03/06/2001 Pt awoke at 00:30 on 3/3/01 with apparent fever. Felt very hot to mother-no thermometer. Took off clothing and administered acetaminophen product. Later that day, the pt broke out in a red rash on face, neck, chest, back, arm, legs, feet and hands. Mother gave Benadryl. Rash still apparent on 3/6/02 and face was a red splotchy appearance. U 02/22/2001 03/02/2001 8 NONE PUB PUB NONE Just off antibiotics for bronchitis. OH0009 1
0167831 03/26/2001 CO 42.0 42 F 03/07/2001 Mild exacerbation of asthma, flu-like symptoms, most likely related to pneumovax. Asthma (now) 2/22/01 stable, left arm redness and stable 2/22/01 as pt taking Benadryl. Mild urticaria. Y Y 02/21/2001 02/22/2001 1 PVT PVT Calcium, Claritin D, Flovent, Valtrex, St John's Wort Allergies, asthma, chronic fatigue syndrome 1
0167832 03/26/2001 TN 17.0 17 M 02/13/2001 Kept pt in clinic room a few minutes, post vax, talking to him. Stated he was ok and left clinic room. In the lobby, he passed out and hit back of the head on the floor. He was observed in clinic room; BP was stable; complained of nausea and was taken to doctor and dx'd with a concussion. Y Y 10/23/2000 10/23/2000 0 UNK PUB PUB NONE NONE NONE TN01009 1
0167833 03/26/2001 NJ 4.0 4 M 03/16/2001 Child given DTAP in left deltoid. Almost immediately, redness developed on left arm. By the next day, arm was swollen and minimally tender. Y Y 03/13/2001 03/13/2001 0 PVT PVT NONE NONE 1
0167834 03/26/2001 MA 1.25 2 .2 F 03/16/2001 02/01/00, vaccines given and pt developed a papular rash on both legs and took 6 days to go away. Y 02/01/2000 02/02/2000 1 PUB PUB NONE NONE NONE 1
0167835 03/27/2001 KY 0.08 0 .1 F 03/19/2001 The pt was taken to a local ER for cardiopulmonary arrest less than 24 hours post vax. Autopsy gave final diagnosis of SIDS. Autopsy also shows pulmonary congestion, visceral congestion. Y 11/29/2000 N 11/28/2000 11/29/2000 1 Autopsy - SIDS PVT PUB NONE NONE 1
0167836 03/27/2001 KY 6.0 6 F 03/21/2001 The child was administered immunizations in the clinic per protocol. She was observed in the clinic 20 minutes without any adverse effects. The child and mother went to the local library where the child experienced a seizure. She was transported by ambulance to the local hospital and then transferred to another Hospital. Y 1 Y 03/15/2001 03/15/2001 0 CT Brain Scan PUB OTH Bronchitis KY2001021 1
0167837 03/27/2001 MD 46.0 45 F 02/26/2001 This patient had intermittent pain at the site of the injection. Throbbing pain awakening the patient all night. She often was unable to move or lift her right arm certain ways. Rotator cuff issue ruled out. Regime of Celebrex and stretching provided relief temporarily. No often "lymes-type" symptoms felt at all. The patient had her 2nd vaccine 04/25/00, the third vaccine never occurred. Y Y 03/22/2000 05/01/2000 40 PVT UNK NONE NONE NONE 1
0167838 03/27/2001 MA 4.0 4 F 03/21/2001 Onset of hives, 24 hours, post vax, and progressed to severe serum sickness in 4 days. (Low-grade fever, minimal cough at the same time) Pt was hospitalized with high dose IV steroids and prelone taper. Y 2 Y 03/13/2001 03/14/2001 1 ESR/CBC and skin testing to follow PVT PUB NONE NONE 1
0167839 03/27/2001 GA 0.25 0 .2 F 03/21/2001 Began seizing 2-3 hours, after given the DPT vaccine and was hospitalized after each DPT vaccination. Became severely retarded. Per MD, the 1st convulsion lasted several hours and she has continued having them, especially with fever, but also without fever. Some of these are quite prolonged and the mother recalls one time when she had twitching intermittently all day. The parents state she has these after every DPT injection, which was given in half doses after her initial reaction, the convulsions became worse. At the present time, she actually has 2 types; the 1st type consists of right or left tonic and clonic movement, lasting 3 to 5 minutes. She also has akinetic or drop seizures which cause her suddenly to be thrown backwards, falling to the floor, but she will get up immediately. For the past year, she takes Phenobarbital and Mysoline 3 times a day. She used to be on Dilantin but no longer takes that. She has been hospitalized at least 6 times for seizures. She has had physical therapy which did not help. The mother has a history of seizures. The child is quite retarded. She has an ataxic gait with unsteadiness. She is small size. I think the basis for this is quite clearly due to the reaction to IZ or in other words, post pertussis encephalopathy. I don't think there is anything that can be done for the child except to continue her anti-convulsants and I do think that when she gets bigger she may be somewhat of a management problem and require institutionalization. I told the family that this is not hereditary and they should go ahead and have further children but with an absolute contraindication that no subsequent child should receive DPT but only DT. Y Y Y N 03/06/1963 03/06/1963 0 PVT UNK NONE NONE NONE 1
0167840 03/27/2001 VT 0.5 0 .5 F 03/19/2001 Runny nose, fever, fussy, red dime-sized circle on left thigh at Prevnar site. Dx'd with URI and Prevnar reaction, approx. 1 cm in diameter. Y Y 02/28/2001 03/01/2001 1 PVT PVT Mycostatin Oral thrush NONE 1
0167841 03/27/2001 VT 0.2 0 .2 F 03/19/2001 Fever, red, dime-sized circle on left upper thigh at Prevnar site. Dx'd with local reaction to Prevnar approx. 1 cm diameter. Y Y 02/28/2001 03/01/2001 1 PVT PUB NONE NONE 1
0167842 03/27/2001 VT 3.0 3 M 03/19/2001 Mom reported on 3/14/01 to nurse, while in office with second child, that this pt presented with a hard lump at injection site of Prevnar. Said it was swollen and red, approx. size of a ping-pong ball. Thought it was normal reaction so did not call us. On 3/14/01, he still had hard lump at site. Child was not with mother when reported. Y 12/14/2000 12/15/2000 1 NONE PVT PUB 1
0167843 03/27/2001 VT 2.0 2 .3 M 03/19/2001 Fever, complaining of leg pain X 2 days, large red and tender area 7.5cm X 11cm. Dx'd with local reaction at Prevnar site. Y Y 02/27/2001 03/01/2001 2 NONE PVT PUB NONE NONE 1
0167844 03/27/2001 VT 1.5 1 .5 F 03/19/2001 Complained of pain to left thigh and red. Triage done, seen by MD on 3/4-3/6 for ? viral GE. Y Y 02/27/2001 03/01/2001 2 NONE PVT PUB Bilateral serous otitis media 1
0167845 03/27/2001 VT 3.0 3 F 03/19/2001 Fever, complaining of being sore on 2/22/01. Seen my MD on 2/26/01 and dx'd with viral syndrome and right serious otitis media. On 2/27/01, triage for cough, decrease in po intake. Y Y 02/21/2001 02/22/2001 1 NONE PVT PVT NONE 1
0167846 03/27/2001 SC 2.0 2 .2 M 03/02/2001 On 3/2/01, parent reports that pt had approx. 1" hard knot with redness and "felt hot" where shot was given. Occurred on 3/1/01 at approx. 14:30. No temperature taken. 1 chewable Tylenol given to pt. At approx. 20:00, pt had SOB and was lethargic; so was given albuterol. Called PMD on 3/2/01 at 08:45 and got an appt. for 14:30. Child was much improved at this time, 09:00. Y Y 02/28/2001 03/01/2001 1 PUB PUB In 1st year with history of bronchiolitis prn nebulizer/inhaler use SC0109 1
0167847 03/27/2001 ME 2.0 2 .2 F 03/23/2001 Vaccine administration on 3/20/01 PM, reaction on 3/21/01 PM; deltoid area below elbows was red, swollen and warm. No puss, non-tender. Saw pt on 3/22/01 and symptoms still present. U 03/20/2001 03/21/2001 1 PVT PUB NONE NONE NONE 1
0167848 03/27/2001 PA 3.0 3 F 03/06/2001 Temperature elevation to 40C, starting within hours of Prevnar vaccination and lasting 3 days. Y Y 02/27/2001 02/27/2001 0 PVT PVT NONE NONE NONE 1
0167849 03/27/2001 FL 1.5 1 .6 F 03/15/2001 High fever, onset evening of the day child was vaccinated. Fever of 104F and left leg swelling with stiffness. Y U 03/14/2001 03/14/2001 0 PVT PVT NONE NONE 1
0167850 03/27/2001 CA 4.0 4 M 03/15/2001 Large area of erythema and induration; almost entire arm (left) from shoulder to elbow. Date of onset-3/14/01. Y 03/13/2001 03/14/2001 1 NONE PVT PVT NONE NONE 1
0167851 03/27/2001 MO 0.2 0 .2 M 03/19/2001 The pt had his vaccines at 10:00 and at 1:30 vomited 3 times. Mom states that he appeared to be choking or vomiting and when mom picked him up he was staring ahead and would not respond to her voice or shaking. This lasted for approximately 1 minute. No color change and breathing did not stop. Y 02/21/2001 02/21/2001 0 PVT PVT NONE NONE NONE 1
0167852 03/27/2001 GA 1.75 1 .6 F 03/20/2001 The pt broke out in a rash all over her body. Y 03/16/2001 03/16/2001 0 PVT OTH 1
0167853 03/27/2001 CA 0.2 0 .2 M The pt experienced a rash on legs with an onset date of 2/28/01. Y 02/26/2001 02/28/2001 2 NONE MIL MIL NONE NONE NONE 1
0167854 03/27/2001 MI 0.2 0 .2 M 03/12/2001 Immediately post vax, the pt held breath, became very pale. An ammonia stick was placed under nose - baby acted like he fainted. Respirations shallow, slowly became more alert but took 10-15 minutes. Baby went to PMD. Y Y 03/12/2001 03/12/2001 0 PUB PUB NONE NONE NONE MI2001023 1
0167855 03/27/2001 MI 1.08 1 .2 F 03/15/2001 The pt woke up at 1:00 am with a fever of 101, vomiting, shaking and very irritable. Vomiting was constant and would not stop. Taken to the ER and given an unknown medication for vomiting and an antihistamine. Advised liquids for 24 hours. Y 03/13/2001 03/15/2001 2 NONE PUB PUB NONE NONE NONE MI2001025 1
0167858 03/27/2001 TX 51.0 51 M 03/02/2001 Rash appeared on pts hands - reddened, tiny raised nodules in clusters and individual. Rash spread to legs - non-raised just spots. Y 02/23/2001 02/27/2001 4 OTH OTH NONE NONE NONE 1
0167859 03/27/2001 NC 55.0 55 F 12/06/2000 On 12/6/00, red, swollen and hot area, with temperature of 100.3F. Has nausea and feels bad. Treated with Keflex. On 12/13/00, pt doing well. Y Y 12/04/2000 12/05/2000 1 PUB OTH BP med and hormone NONE Allergic to sulfa NC01036 1
0167861 03/27/2001 IN 3.0 3 F 03/26/2001 Left thigh cellulitis that started 1 day, post vax. Keflex given. Y Y 02/27/2001 02/28/2001 1 NONE PVT PVT Amoxicillin Otitis Media NONE 1
0167862 03/27/2001 OH 55.0 55 F 02/28/2001 On 2/27/01, 23:59 midnight (38 hours, post vax) client stated that she experienced soreness in the left chest area through to her back. States it hurts to turn head to the left. Pain relieved by aspirin. Referred to doctor. Y 02/26/2001 02/27/2001 1 PUB PUB Prempro NONE NONE 1
0167863 03/27/2001 MI 1.4 1 .4 M On 11/7/00, pt was given his MMR vaccine and 9 days later, he developed high fevers for 2 days. On 11/16/00, he started to develop a rash that was measles-like. The rash started to disappear on 11/19/2000. Treated with Augmentin. Y 11/07/2000 11/16/2000 9 PVT UNK Augmentin Recent Otitis Recent Otitis 1
0167864 03/27/2001 PA 7.0 2 .0 F 03/02/2001 The mom called on 3/1/01 and stated the child broke out with chicken pox. The pt also had a fever. Y 08/07/1995 03/01/2001 2033 NONE PVT UNK NONE NONE 1
0167865 03/27/2001 CT 3.0 F 02/25/2001 Pt was sent home from school on 02/15/2001 with suspicious bumps on her torso. The next day she broke out with the chickenpox. Her siblings have not as yet shown any symptoms of the chickenpox. Y 02/15/2001 PVT PVT Given Tylenol for pain from injection NONE NONE 1
0167866 03/27/2001 FL 46.0 46 F 03/23/2001 One day post vax, face became red and bumpy around nose. Redness became more extensive by 03/22/2001. Seen by MD and advised to treat with OTC steroid cream. Area became more red, bumpy and covered a larger area to include nose, cheek, and chin. Area was itchy and throbbing. Y N 03/20/2001 03/21/2001 1 OTH PVT OTC sleep aid NONE menstrual irregularity 1
0167867 03/27/2001 VA 1.0 1 .0 F 03/16/2001 The pt developed a local reaction to the DTaP and MMR consisting of redness and itching. The pt also experienced herpes zoster and dermatomes. Y U 02/10/1998 03/10/2001 1124 herpes/varicella, viral culture - pending PVT OTH NONE NONE 1
0167868 03/27/2001 MI M Pt developed swelling and erythema at the site of the immunization with pain and tenderness over the deltoid muscle and in the axilla. Y 03/08/2001 03/09/2001 1 NONE PVT UNK Dog bite NONE 1
0167869 03/27/2001 VT 1.2 1 .2 F The pt became fussy, experienced increased sleeping the same day of the vax. The pt also experienced urticaria increasing over the next 24 hours. N 03/13/2001 03/14/2001 1 PVT PUB URI 1
0167870 03/27/2001 FL 1.5 1 .6 M 03/09/2001 Immediately following vaccination, the pt broke out in a red rash and whelps. The pt was treated with Benadryl. Y 03/16/2001 03/16/2001 0 PVT PUB NONE 1
0167871 03/27/2001 CA 1.14 1 .1 M 03/19/2001 The pt experienced a generalizes seizure on the same day as vax. Y Y 03/17/2001 03/17/2001 0 PVT PUB NONE NONE hx of previous febrile seizure 1
0167872 03/27/2001 SC 17.0 17 M 02/05/2001 The pt developed tachycardia, generalized weakness and dizziness. The pt had pain in shoulders and back. The pt experienced peeling as well. The pt had to be dismissed from school, and slept for hours at home. The pt was taken to the doctor. No fever was noted and the MD couldn't state that the symptoms were due to vaccine or not. Y Y 01/29/2001 01/29/2001 0 OTH PUB NONE eczema, allergy to almonds unspecified reaction~DTP (no brand name)~3~2.00~In Patient SC0113 1
0167873 03/27/2001 SC 11.0 11 F 03/12/2001 Mom stated the pt started itching on 3/10/01. Mom noticed the pt broke out in whelps all over the front and back of trunk. On 3/11/01 the pt is still itching and mom denies the pt having a fever, nausea, vomiting. Y N 03/09/2001 03/10/2001 1 NONE PUB PUB Claritin NONE allergy to dust mites and hx of seizures SC0112 1
0167874 03/27/2001 SC 39.0 39 F 02/15/2001 The pt complained of redness, swelling, at the injection site which was 30-40 mm in size. Pt was instructed to see PMD. Y Y 02/12/2001 02/14/2001 2 PUB UNK NONE SC0111 1
0167875 03/27/2001 SC 14.0 14 F 03/15/2001 3-5 minutes post vax, the pt fell hit his nose on the counter, had mild jerking motion, unresponsive for several seconds. Swelling to the nose, complained of neck pain when sitting up. Ice was applied to nose. The pt was transported via spinal board to ER by EMS. Y Y 03/15/2001 03/15/2001 0 NONE OTH PUB NONE NONE NONE SC0114 1
0167876 03/27/2001 SC 4.0 4 M 03/12/2001 The pt experienced a red, swollen left arm that is so tight it looks as if it is going to burst. This is from the shoulder to the elbow. Instructed to take the child to PMD. Y Y 02/20/2001 02/22/2001 2 UNK UNK SC0115 1
0167877 03/27/2001 HI 4.0 4 F 03/12/2001 The pt experienced a localized reaction at the injection site to the right deltoid with pain, swelling and erythema. Y 03/05/2001 03/06/2001 1 NONE PVT PVT NONE NONE NONE HI0103 1
0167878 03/27/2001 MI 13.0 12 F 02/26/2001 The pt complained of chills, fever, ached all over especially eyes and had a hard time getting up and walking. Mother took her to the ER and they kept her for 5 hours. Tylenol was given then she was sent home. Y Y 10/17/2000 10/17/2000 0 NONE PUB UNK NONE MI2001020 1
0167879 03/27/2001 MI 1.5 1 .7 M 01/30/2001 Mom states that the pt has swelling in the right leg to twice the normal size with redness. No defined lump at this time. No fever or pain. The child is playing with no complaints. As of 1/31/01 the symptoms are resolving with no fever or pain. Y Y 01/29/2001 01/30/2001 1 NONE PUB PUB NONE NONE allergy to Amoxicillin MI2001022 1
0167880 03/27/2001 MI 17.0 17 F 03/12/2001 The pt had a fever, chills, weakness. She felt faint but did not pass out. Y 01/11/2001 01/12/2001 1 NONE PVT PVT NONE NONE NONE MI2001024 1
0167883 03/28/2001 FL 0.2 0 .2 F 03/23/2001 The mother of a 2 month old infant (at the time of receipt of Tetramune) reported that her daughter received IM injection of Tetramune and oral Orimune on 1/12/96. It was noted that she received Engerix-B on 12/15/95. On 1/24/96, the pt was hospitalized and dx'd with an intraventricular stroke. She was on life support for the first 7 to 10 days of the hospitalization, which lasted 85 days. Now, at age 5, the pt does not walk or speak and is visually impaired. She also has a seizure disorder and "global delays". She has a "shunt" placed to control hydrocephalus. Y N 01/12/1996 01/24/1996 12 UNK PVT PVT NONE NONE UNK HQ8738322MAR2001 1
0167884 03/28/2001 KS 18.0 18 M 03/15/2001 An 18 year old man seen in follow up on 03/16/01 for vaccine reaction. The patient reported left arm pain, left chest pain, nausea, and SOB. Evaluated in the ED on March 01 and released . Sent back to ED on 03/16/01, due to continued sickness. Normal exam and lab work and resolution of sickness after ED eval Y Y Y 03/15/2001 03/15/2001 0 EKG; Cardiac enzymes; CBC; CMP-ALL WNL; CXR-respiratory distress MIL MIL NONE NONE NONE 1
0167889 03/28/2001 OR 61.0 61 M 03/19/2001 Light flashes (started on 5/10/99), tingling and numbness in feet (started approx. 6/99), intense back pain (started 6/21/99), weakness and numbness in both arms and right hand (started 12/15/99). Numbness in feet is daily; other symptoms, including hand cramps that started later, are intermittent. 60 day follow-up states the pt also experienced neck stiffness and visual problems. Y N 05/05/1999 05/10/1999 5 EMG of legs, back, arms; Cervical X-ray and MRI; Brain MRI; Eye exam for detached retina; various and repeated blood tests. PUB PUB Zestoretic, Cardura, Aspirin NONE Hypertension, Allergies to PCN, Cephalexin, Procardia, Atenolol 1
0167890 03/28/2001 GA 0.75 0 .5 F 03/23/2001 This infant had bilateral otitis media, fever, bacteremia, streptococcus pneumoniae, strep pneumo AG positive, gram, positive cocci in pairs in chains. Y Y Y 12/15/2000 02/09/2001 56 CBCD, BC PVT PVT NONE NONE Premature at 32-33 weeks gestation. 1
0167891 03/28/2001 GA 18.0 18 F 03/29/2001 This patient had sudden episodes of severe weakness to the point of total paralysis, being unable to use his extremities or able to sit up on her own lasting 1 1/2 - 2 hours. These started approx 2 weeks post-vaccination and continued through early to mid February 2001. Y Y 1 Y 11/08/2000 11/30/2000 22 Chemistry Proteins, CBC, MRI of the brain, C-Spine, EEG, Echocardiogram, X-Rays of the abdomen & lungs, EKG x 2. OTH PVT NONE Chronic tonsillitis 1
0167892 03/28/2001 CA 5.0 4 F 03/22/2001 Pt developed leg weakness and atrophy which was slowly progressive (left leg worse than right leg). This was progressive over 6 months to the point that she could no longer walk unassisted. She was admitted and dx'd with anterior horn cell lesion and received inpatient rehabilitation. Y 13 Y N 08/08/1999 10/01/2000 420 EMG/NCS-anterior horn cell lesions; left lower worse than lower right PVT OTH IVP given on 8/8/99 NONE 1
0167893 03/28/2001 FL 0.5 0 .5 M 03/12/2001 The pt experienced a rash at the vaccine site. Y 03/09/2001 03/11/2001 2 PVT PVT NONE NONE unspecified~DTaP (no brand name)~2~0.00~In Patient 1
0167894 03/28/2001 WI 1.25 1 .3 F 03/20/2001 The pt developed a morbilliform rash, and fussy for a couple of days. Y 02/26/2001 03/09/2001 11 PVT PVT NONE hx of viral exanthem 1
0167895 03/28/2001 CA 1.0 1 .0 F 03/21/2001 The pt experienced acute onset facial swelling, erythema, scleral lesions on arms, treated with Benadryl. The pt also had periorbital swelling which progressed to the point where the pt was unable to open her eyes. Swelling improved promptly with administration of Benadryl. Y 03/21/2001 03/21/2001 0 NONE PVT PVT NONE NONE NONE 1
0167896 03/28/2001 MS 0.75 0 .8 F 03/22/2001 The pt experienced a red rash and a splotchy head and face. Y Y 03/19/2001 03/19/2001 0 PUB OTH Omnicef bilateral otitis media NONE 1
0167897 03/28/2001 SC 4.0 4 M 03/22/2001 The pt experienced a large 2 1/2 x 2 1/2 inch whelp that developed at site which was red and hard. Treated with warm compresses. No SOB or fever was noted. Y 03/19/2001 03/21/2001 2 NONE PVT OTH NONE NONE prematurity, umbilical hernia, allergy to PCN and Ceclor 1
0167898 03/28/2001 GA 1.0 1 .0 M 03/19/2001 The pt woke up on 3/18/01 with a rash starting at head and working down. The pt describes as "diffuse morbilliform rash" worse on head". The pt was scratching at the head and refused to eat or sleep. The pt had a fever of 101.0 since onset of rash. Y Y 03/08/2001 03/18/2001 10 NONE PVT PUB Amoxicillin, synagis shots right otitis media, URI NONE 1
0167899 03/28/2001 CA 1.6 1 .6 M 03/20/2001 The pt experienced urticaria within 24 hours post vax. The pt also had the same reaction with the 1st dose. Y U 03/16/2001 03/17/2001 1 NONE PVT PVT NONE epistaxis small for gestational age 1
0167900 03/28/2001 WA 0.3 0 .4 F 03/20/2001 The pt experienced head to toes red bruised lesions. Almost chicken pox like in appearance. Onset was within 15 hours of administration. This was accompanied by a low grade fever. Y U 03/19/2001 03/20/2001 1 PVT PUB NONE NOEN 1
0167901 03/28/2001 WI 1.0 0 1 M 03/17/2001 The pt developed erythema multiforme hive like reaction 6 days after the vaccinations. The pt also ran a fever of 104. The pt has recovered without sequelae. Y Y 03/07/2001 03/13/2001 6 PVT UNK 1
0167902 03/28/2001 KS 0.2 0 .2 F 03/19/2001 The pt experienced a screaming cry, unconsolable from 10:30 am to 8:00 pm (on and off). Did sleep some. The pt had a fever of 103. Gave Tylenol every 4 hours. Y 01/10/2001 01/10/2001 0 PUB PUB NONE NONE NONE 1
0167903 03/28/2001 IA 2.0 2 .0 F 03/21/2001 The pt developed hives on 3/20/01 with a large area of erythema at the site of Prevnar injection. Y 03/15/2001 03/20/2001 5 PVT PVT NONE NONE NONE 1
0167904 03/28/2001 OH 0.75 0 .8 F 01/30/2001 Within 24 hours of injection the pt experienced a fever of 104 for 3 days. Lips and tongue were swollen. The pt was treated with Tylenol and fluids. Y 01/17/2001 01/17/2001 0 NONE PVT PVT URI NONE 1
0167905 03/28/2001 WI 1.5 1 .5 M 03/21/2001 Approximately 1 day post vax, the pt had swelling in left arm with a reddened line below area of injection. Normal ROM, however guarding arm. No fever noted. The pt was seen by an MD. Y Y 03/19/2001 03/20/2001 1 NONE PVT PUB NONE dog bite to face NONE 1
0167906 03/28/2001 OR 2.0 2 .6 F 03/22/2001 The pt experienced a rash. U 03/20/2001 03/22/2001 2 NONE PVT PVT NONE NONE NONE 1
0167907 03/28/2001 CA 1.25 1 .2 F 03/21/2001 The pt experienced a fever on 3/20/01 and on 3/21/01 the pt was acting fine and then suddenly started shaking while sitting, than collapsed. Mom states the pt was unresponsive. Y Y 03/12/2001 03/21/2001 9 PVT PVT Tylenol, Motrin NONE 1
0167908 03/28/2001 IL 1.0 1 .0 M 03/22/2001 Mom called on 3/21/ and stated that at the injection site there was a red line with "pus spots". Mom wasn't sure if there was a fever or not. Injection site was the (R) leg. Y U 03/08/2001 03/21/2001 13 PVT UNK Rynatan, Beconase NONE NONE 1
0167909 03/28/2001 MA 4.0 4 F 03/16/2001 The pt experienced an itchy blotchy red rash on body. Eyes were puffy. Treated with Benadryl. Symptoms disappeared following second dose. Y 01/25/2001 01/25/2001 0 PVT PUB NONE 1
0167910 03/28/2001 MA 1.25 1 .3 M The pt had an immediate wheal reaction to 3cm. There was non respiratory distress. Treated with Zyrtec and the pt was observed for 20 minutes at which time swelling had decreased. Y 03/09/2001 03/09/2001 0 PVT PUB 1
0167911 03/28/2001 MA 1.5 1 .3 F The pt experienced a 2 cm wheal within two minutes of giving the MMR. There was not respiratory distress. The pt was treated with Zyrtec. The pt was observed for 30 minutes at which time swelling had decreased. Y 01/05/2001 01/05/2001 0 PVT PUB 1
0167912 03/28/2001 1.7 1 .6 M 02/26/2001 The pt experienced urticarial rash over joints and the progressing to trunk. The pt also experienced erythema multiforme. Y Y 02/21/2001 02/23/2001 2 NONE MIL MIL Amoxicillin, Augmentin otitis media 1
0167914 03/28/2001 MD 16.0 15 F 03/26/2001 The pt experienced a rash, itching, developed several days later, whole body rash, scabbed over developed several days after. Rash continues today with itching. Y N 11/28/2000 11/30/2000 2 skin biopsy PUB PUB NONE NONE NONE 1
0167915 03/28/2001 PA 6.0 1 .0 F 03/26/2001 The pt woke up on 3/24/01 with a fever of 104. By that evening, the pt's parents noticed pox. She now has greater than 100 pox covering her body. Y 02/16/1996 03/24/2001 1863 NONE PVT PVT NONE NONE NONE 1
0167916 03/28/2001 CA 1.4 1 .4 M 03/14/2001 The pt experienced redness, swelling, and warmth to the touch of the LAT. No fever was noted. Treated with Motrin and Benadryl. Y 03/13/2001 03/14/2001 1 NONE PVT PVT NONE NONE NONE 1
0167917 03/28/2001 TX 48.0 48 F 03/01/2001 Pt developed a bruise at the injection site that spread up the arm and down towards the elbow, characterized by lines of black, blue and yellow. Symptoms lasted for over one week. Y 02/01/2001 02/01/2001 0 PVT UNK NONE NONE 1
0167918 03/28/2001 MI 14.0 14 F 03/21/2001 The pt complained of rash for 1 1/2 weeks. The pt experienced a cough, possible fever, sore throat, and a pink macular-papular rash on trunk, arms and on the face. U 03/09/2001 03/19/2001 10 IgM measles titer OTH OTH NONE asthma 1
0167919 03/28/2001 CA 21.0 21 F 03/21/2001 Hep A vaccine #2 was given only one month after #1 instead of 6-12 months later. No adverse events. U 02/02/2001 NONE OTH PVT NONE NONE 1
0167920 03/28/2001 TX 2.0 2 .6 F 03/21/2001 The pt experienced erythema around the injection site, mild swelling, no other problems. Y U 03/19/2001 03/19/2001 0 PUB PUB 1
0167921 03/28/2001 TX 4.0 4 M 03/22/2001 2 days post vax, the pt experienced tremendous swelling of injection site with redness, hot to the touch and somewhat painful. Swollen from the hip to the knee. Erythema covered a 25cm x 25cm area. U 03/20/2001 03/21/2001 1 NONE PVT PVT NONE NONE reactive airway disease, speech articulation disorder 1
0167922 03/28/2001 KS 24.0 24 M 03/15/2001 Approximately 2 hours post vax, the pt became nauseous, fatigued, experienced left arm soreness and reportedly decreased LOC with increased respiratory rate. The pt also experienced a skin rash and dry mouth, left arm soreness primarily at elbows. Y Y 03/15/2001 03/15/2001 0 NONE MIL MIL NONE NONE NONE 1
0167923 03/28/2001 DE 1.5 1 .5 M 03/21/2001 The pt experienced a large local reaction at the site. Treated with aspirin and Motrin. U 03/20/2001 03/21/2001 1 PVT PUB Levoxyl 1
0167924 03/28/2001 ID 0.8 0 .7 F 03/20/2001 The pt had a medium to large hard raised bump that continued for the first month. Two months later there is still some hardness in the same are the DTP was given. Y 01/25/2001 01/25/2001 0 PVT PUB NONE NONE NONE 1
0167925 03/28/2001 CA 4.0 3 M 03/20/2001 The pt experienced a rash at the site of injection at the left arm. Y 03/08/2001 03/15/2001 7 NONE PVT PUB NONE NONE 1
0167926 03/28/2001 FL 25.0 25 M 03/09/2001 The pt was seen on 3/5 for left hand laceration. A TD was given in the right deltoid. The pt returned on 3/7 complaining of pain and redness at the injection site. Diagnosed with cellulitis to right shoulder area. Y Y 03/05/2001 03/06/2001 1 PVT PVT NONE left hand laceration 1
0167927 03/28/2001 FL 65.0 65 F The pt received a TD for facial abrasions on 3/12/01. On 3/15/01 she returned for a follow-up of injury and mentioned her right are was painful. She was placed on antibiotics. U 03/12/2001 OTH UNK hx of asthma and CA 1
0167928 03/28/2001 FL 23.0 23 F 03/10/2001 The left deltoid had increased warmth, increased pain, increased swelling post the TD vax on 3/8/01. Y 03/08/2001 03/09/2001 1 UNK UNK left foot laceration allergy to PCN 1
0167929 03/28/2001 OH 19.0 19 M 03/12/2001 Pt developed an urticarial rash on bilateral arms, armpits, posterior legs, back, chest and neck. Pt denies respiratory symptoms. Pt treated with Benadryl, Kenalog, and Atarax. Y 03/06/2001 03/12/2001 6 OTH UNK NONE 1
0167930 03/28/2001 MO 1.5 1 .6 F 03/12/2001 On 3/12/01 pt had a 40mm diameter reddened area on right vastus lateralis area which also has many small red dots within the area. Mother reports a low-grade fever, appears to have pain with walking. On 3/15/01, mother reports rash almost gone. Y Y 03/06/2001 03/11/2001 5 PUB PUB MO2001014 1
0167931 03/28/2001 MO 14.0 14 F 03/19/2001 Onset of rash/hives, pruritus 2 hours, post vax. Rash on arms, chest and back. Was given Benadryl. Itching continued. Hives dissipated by time of doctor visit. Approx. 15:00, red blotches on arms. Injection site 2"-3" erythema, pruritic, no swelling. T-95; R-14; lungs-CTA; AHR-82; BP 98/62; 124 lbs. No resp. difficulties. Decadron given IM and Claritin po in office, then prn every 12 hours. Dx: dermal reaction. Y Y 03/09/2001 03/09/2001 0 NONE PUB PUB NONE MO2001016 1
0167932 03/28/2001 MO 5.0 5 F 03/21/2001 Broke out around 3/12/01 with small bumps that appear to have a blister on them. Brother had chickenpox, 2 weeks prior. DX: Chickenpox. Y 03/02/2001 03/12/2001 10 PVT PVT NONE NONE 1
0167933 03/28/2001 CA 4.0 4 F 03/19/2001 Large swelling occupying most of the left thigh which developed 1-2 days, post vax. Skin erythematous with a few vesicular eruptions. Swelling lasted 5-6 days but redness and oozing vesicles lasted 7-8 days and subsided. Indurated, dark pigmentated 10cm X 10cm patchy area. Itching lasted 2 weeks. Y Y 02/26/2001 02/27/2001 1 NONE PVT PUB NONE Allergy to penicillin 1
0167934 03/28/2001 CA 4.0 4 M 03/02/2001 Rt arm from deltoid to just below elbow was red, swollen, very warm to touch on lateral half of arm. Also had pain and itching X today. Slight redness and itching, yesterday with slight pain and itching on day of vaccine. Had previous reactions with DTP vaccines at age of 2 mo, 4 mo, 6 mo and 18 mo. Y 02/28/2001 03/01/2001 1 CBC-Slightly increased WBC; Blood culture-no growth after 3 days. EEG-nml on 12/28/99; scheduled for skin testing in Allergy Clinic on 3/27/01. PVT PUB NONE NONE Allergies to milk, chocolate, Keflex, Erythromycin? Jerking movements, eyes rolled up~DTP (no brand name)~~0.20~In Patient 1
0167935 03/28/2001 CA 3.0 3 M 03/19/2001 Developed generalized urticaria 15-20 minutes following MMR. Got Epi SC, Prelone and Zyrtec. Observed for 45 minutes and sent home with Prelone X 4 days. Y Y 03/13/2001 03/13/2001 0 PVT PUB Eczema, food allergies 1
0167936 03/28/2001 MO 1.25 1 .4 M 03/15/2001 Rt anterior thigh has 3" diameter red circle that is swollen and warm to touch. No systemic signs and symptoms (i.e. fever) but is "favoring" right leg. Ambulates "fine". This leg received DTAP. Left anterior thigh has the same signs and symptoms but to a much lesser degree without any problems. Y 03/13/2001 03/14/2001 1 NONE PUB PUB NONE NONE NONE MO2001015 1
0167937 03/28/2001 SC 4.0 4 F 03/23/2001 Round indurated erythematous 4.5cm X 4cm round lesion. Y 03/21/2001 03/22/2001 1 NONE OTH OTH NONE NONE NONE 1
0167938 03/28/2001 MI 26.0 26 M 03/13/2001 Pt experience right deltoid tenderness and induration; myalgias; arthralgias; fever; and peripheral neuropathy - right extremities Y 03/05/2001 03/06/2001 1 NONE PVT PVT recovering from viral syndrome 1
0167939 03/28/2001 IN 18.0 18 F 03/25/2001 Became unresponsive with contracture of hands and arms, aching back. Unresponsive for approx. 1 minute and then responded to verbal stimuli. Relaxed muscles for 1-2 minutes at which time another similar episode occurred. Sent to her PMD for exam. Y 03/20/2001 03/20/2001 0 NONE PUB PUB Birth control pills NONE NONE 1
0167940 03/28/2001 CA 4.0 4 F 03/19/2001 This child had mild induration, erythema right leg on Thursday 03/15/01 @ 19:00. She had mild pain, better on 03/19/01. Instructed to take Tylenol for the pain. Doctor informed patient discharged without complaints. Y 03/15/2001 03/15/2001 0 PUB PUB Albuterol Pneumonia resolved NONE 1
0167941 03/28/2001 AR 0.5 0 .5 M 03/23/2001 This infant is shaky, not acting right, suddenly started screaming. Calmed down but couldn't eat, he went limp, staring, not responding, temp 101, breathing funny, no apnea, sleepy 1 hour later. 1 to 2 hours later acting fine, no fever. Y 03/13/2001 03/15/2001 2 CBC with MD and BMP - both Nml. PVT PVT NONE Cough RAD 1
0167943 03/28/2001 WA 1.08 1 .0 F 03/19/2001 This patient received her MMR, HIB, and Varivax vaccines on 02/12/01. On 03/07/01, she developed a low grade fever, parotid swelling without erythema, and her stenosis ductus was slightly swollen. Resolved after 4 days. Y Y 02/12/2001 03/07/2001 23 NONE PVT PUB NONE NONE Dacroyostenosis 1
0167944 03/28/2001 NY 4.0 4 M 03/15/2001 This child was vaccinated with DTaP, IPV, and MMR on 03/13/01. The following day his left arm was erythematous, and painful. Y 03/13/2001 03/14/2001 1 Cellulitis PUB PUB NONE NONE 1
0167945 03/28/2001 OH 1.75 1 .7 F 03/20/2001 This child's entire lateral / anterior surface of the left thigh red, warm, and swollen. U 03/09/2001 03/10/2001 1 NONE PVT PVT Eczema, very dry skin. Eczema. 1
0167946 03/28/2001 OH 34.0 34 F 03/20/2001 This patient had swelling to her left armpit, pain when trying to close her arm; lasted 2 days. Resolved. Y 01/29/2001 01/30/2001 1 PUB OTH NONE NONE 1
0167947 03/28/2001 MD 39.0 38 M 03/20/2001 This patient received #1 Varicella immunization on 02/20/01 (employee had non-immune HZV Titer done on 01/12/01). On 03/07/01, he started running a fever and on 03/09/01, he broke out with slightly small red uniform papules with no pustules (which numbered approx 25 - 30 by 03/12/01) and was located on anterior and posterior trunk, arms, neck and legs. The lesions began with two close to the initial varicella injection site and then continued all over his body. Pruritus was also present with the lesion. Fever stopped on 03/11/01. The lesions stopped breaking out on 03/17/01. the fever ranged from 99 to 102 from 3/7 to 3/11. Y 02/20/2001 03/07/2001 15 PVT PVT NONE NONE Seasonal Allergies 1
0167948 03/28/2001 MI 45.0 45 F 03/20/2001 Starting 10 minutes after administration of vaccination, the patient developed tightness in the chest and some shortness of breath. Progressed in 20 minutes to tonic / clonic spasms of the arms and legs, and inability to speak clearly. The patient was taken to the ER and given IV Valium and recovered immediately. Y Y 03/13/2001 03/13/2001 0 PVT PVT NONE allergic to Sulfa and Penicillin (as a child), GERD. 1
0167949 03/28/2001 NE 46.0 46 F 03/14/2001 On 03/16/01, the patient started having systemic rash. Not experiencing sore throat, or other URI symptoms. On 03/19/01, her physician diagnosed Rubella disease. Y 02/07/2001 02/17/2001 10 NONE PVT PVT Tuberculin Skin Test, Connaught, lot # C0153AB, IM, 02/07/01. Prevacid. NONE NONE 1
0167950 03/28/2001 IL 4.0 4 M 03/22/2001 Parent called to report pt has fever of 100 - 101 accompanied by vomiting. Y U 03/21/2001 03/22/2001 1 OTH OTH 1
0167951 03/28/2001 AZ 3.0 1 .2 F Pustulant lesions on body fever. Y 12/18/1998 03/18/2001 821 PVT PVT NONE NONE 1
0167952 03/28/2001 MA 72.0 72 F 03/22/2001 this patient has swelling on arm in 3" circles. Y 03/19/2001 03/20/2001 1 NONE PVT PUB NONE 1
0167953 03/28/2001 MN 10.0 10 F 03/20/2001 At 4:44 PM, the client received Hep B vaccine. She walked back to the waiting area, sat on a chair and fell forward to the left onto the mother's lap. Assisted to the floor by the mother. The patient was positioned on her back with her knees bent. Initial BP 108/70, P 72. At 5:02 PM BP 124/80, P 78. The patient did not loose consciousness. She was allowed to rest. She recovered and left the clinic approximately 25 minutes later. Y 03/21/2001 03/21/2001 0 PUB PUB NONE NONE 1
0167954 03/28/2001 CA 56.0 55 F 03/25/2001 One week after DT and Hepatitis vaccine, this patient developed a bilateral symmetrical joint pain. Eventually involving all joints except ankles and feet. No swelling, warmth, redness, or tenderness. Y 05/16/2000 05/25/2000 9 Normal ESR, Rheu factor, AANA, CBC, LFT's, and Renal Fx. PVT PVT Progesterone / Estrogen, Thyroid. NONE NONE 1
0167955 03/28/2001 MN 4.0 4 F 03/20/2001 The CMA spoke with the mother of the patient on 03/21/01, the patient is doing fine. The CMA explained to the mother the need for the patient to receive DTaP at her 5 year visit. 03/16/2001 03/16/2001 0 PVT PVT NONE NONE NONE 1
0167958 03/29/2001 FL 37.0 37 M 03/22/2001 No data attached. Per doc 211879, annual follow up, patient still takes chemotherapy to control inflamation and to preserve eyesight. Painful joints and relapses still occur. Also per doc 211879, the anthrax vaccine is responsible for patient auto immune diseases. Patient was very healthy. No indication or past history of symptoms or conditions. The follow up received on 6/27/03 states pt is a 37 year old operating room technician/tattoo artist with incomplete Reiter's syndrome and recurrent scleritis diagosed in August 2000. He had received his 6th anthrax vacciantion on 12/2/99. The pt's syndrome began in April 2000 with the onset of a bilateral inflammatory eye condition throught to be scleritis. He presented to ER on 4/27/00 with fever and pain of back, neck and jaw. He was admitted to the hospital for further evaluation and was discharged 5/2/00. He again presented to ER 5/10/00 for two day history of diarrhea, generalized morning soreness/stiffness and migratory arthralgias. The pt was found to have evidence of painless oral ulceration, diffuse arthralgia, and symptoms of apparent tenosynovitis and synovitis involving the hands. Arthralgias were generalized. Treatment included Prednisone, PredForte eye drops, Indomethicin, and Zantac. Additionally, the pt was completing a 1 month trial of Methotrexate as of 9/29/00. Y Y 5 Y N 12/02/1999 04/01/2000 121 Hep B v sur AB positive, Hep B V core positive, hep B V sur AG negative; X-rays of chest, hands, sacrolliac joint all WNL; elevated ESR; ANA and RF normal; CSF-WNL MIL MIL Ritalin Folic acid vioxx NONE Recurrent upper respiratory tract infection, ADD 1
0167959 03/29/2001 TX 0.5 1 .0 M Within 24 hours, post vax, child developed seizure-like activity later identified by Peds neurologist as infantile spasms; EEG confirmed. per doc 212684, annual follow up, patient has infantile spasms. Y Y Y N 09/15/2001 09/16/2001 1 Full sepsis work up. CT Scan of head, EEG, comp metabolic spinal, organic / metabolic acids. PVT UNK NONE Preterm 31 week 1
0167960 03/29/2001 MS 0.3 0 .3 F 03/15/2001 On past well baby clinic appointment the infant had #2 DTaP, # 2 IPV, and #1 Hib. The mother states that despite the Tylenol, the baby had a seizure which began at 2 PM and got so bad by 6 PM amserv was called. The baby was hospitalized in NICU. Doc 197661 states that mentioned child is being followed by a neurologist and has been placed on anticonvulsants. This physician recommends that the patient receive any immunizations until she is at least 12 months of age. Y U 03/14/2001 03/14/2001 0 Spinal tap, EEG, Blood work up, patient on PB. PUB PUB Generic Reglan for reflux NONE Sibling has ADHD; autism and is on Prozac GI, feveeer, dehydration.~DTaP (no brand name)~1~0.00~In Patient MS01010 1
0167961 03/29/2001 NC 3.0 3 M 03/16/2001 Mother reports post vaccine child had red bumps on body. Y 02/26/2001 03/16/2001 18 PVT PUB Flovent, Nasonex, Zyrtec Asthma Asthma, allergic rhinitis NC01035 1
0167962 03/29/2001 NC 0.4 0 .4 F 03/15/2001 Mother reports fussiness, not sleeping well, inconsolable crying (7 1/2 hrs) Y Y 03/12/2001 03/13/2001 1 PVT PUB NC01038 1
0167963 03/29/2001 PA 1.25 1 .2 M 03/09/2001 Report child has had diarrhea x 3 days, low grade fever/fever up to 102F, red blotches on face U 03/05/2001 03/06/2001 1 PUB PUB PA0125 1
0167964 03/29/2001 TX 1.25 1 .3 M 03/09/2001 The pt experienced swelling of the left thigh with redness around the site at the injection 10 cm in diameter and tenderness. No fever. Y Y 03/05/2001 03/05/2001 0 NONE PVT PUB NONE NONE NONE 1
0167965 03/29/2001 VA 38.0 37 F 03/27/2001 This patient was diagnosed with Lyme Disease in October 1998, after noticing a large red rash on her right hip in July 1998. The rash eventually disappeared, but her hip became very sore and she developed a limp. The hip pain and fatigue were her only symptoms. She began taking oral Cefuroxime. At the end of this time period, she still had some hip pain so so was placed on IV Rocephin, she was almost pain free. She continued symptom free until May 199, after the second Lymerix vaccine. She received the 1st vaccine on 04/12/99, and the 2nd on 05/07/99. Due to the onset of symptoms, she did not receive a 3rd dose. The symptoms below are what she experienced since the 2nd vaccine. Sinus headache and pressure, tingling in her hands, arms, legs, and feet, Burning in her knees, legs feet and arms, Slight pain in her knees and hips. She had tremor, began with stiffness and soreness in her hands, arms and wrist pain. Pain in her knuckles. A pulsating feeling in her head and arms. A burning in her legs and feet, that makes her legs weak. Lightheadedness, and inability to focus or concentrate. It feels like her equilibrium is off. She has a slight jerking movement of her body and limbs, menstrual migraines, sensation of stomach turning over. She does not experience all of these symptoms simultaneously, they seem to come and go. They all began after the second dose of Lymerix. N 05/07/1999 05/15/1999 8 06/29/99 MRI of the brain - Nml. 07/01/99 Lyme Western Blot - Positive. 07/28/99 MRI of the brain attention to the pituitary - 2mm microadenoma in the right side of the pituitary gland. 08/99 EKG - Nml. 09/20/99 Median Nerve Evoked Potential - Nml. 09/20/99 Posterior Tibial Evoked Response - Nml. 09/23/99 MRI cervical without contrast - borderline lyme serology. 01/11/01 Lyme Antigen, Urine - Positive. 01/11/01 Lyme PCR, Serum - Positive. 01/30/01 Babesia & Ehrlichia chaffeenis - Neg. 01/30/01 Lyme PCR - not detected. 02/26/01 Lyme PCR - not detected. PVT OTH Doxycycline, Keflex, Zithromax, IV Rocephin (6 week IV therapy), Cholestyramine, Chitosan. NONE Migraines, Lyme Disease. 1
0167966 03/29/2001 OH 1.75 1 .8 M 03/16/2001 Two days post vax, the pt experienced left thigh swelling with no redness. Pt was treated with ibuprofen and warm compresses. Y 03/06/2001 03/08/2001 2 NONE UNK PUB NONE mild URI NONE 1
0167967 03/29/2001 OH 1.5 1 .5 M 03/16/2001 On 3/14/01, had swelling, induration and warmth. Treated with warm compresses and ibuprofen. Y 03/12/2001 03/14/2001 2 UNK PUB NONE NONE 1
0167968 03/29/2001 OH 0.5 0 .5 F 03/12/2001 On 1/30/01, had local reaction at injection site; lump and pink color. Recommended warm compress, Tylenol and observation. Y 01/29/2001 01/30/2001 1 NONE OTH PUB Neonatal tremor Heart murmur; mild pulmonic stenosis 1
0167969 03/29/2001 OH 0.75 0 .6 M 03/22/2001 On 2/1/01, pt's left thigh was swollen and red. Treated with cold compresses initially and then warm compresses after 24 hours. Y 01/31/2001 02/01/2001 1 NONE OTH PUB URI Prematurity 1
0167970 03/29/2001 OH 1.5 1 .5 F 03/21/2001 On 2/22/01, red and swollen at injection site and fussy. Treated with Benadryl and warm compresses. Y 02/20/2001 02/21/2001 1 NONE OTH PUB Amoxicillin Chronic serous otitis media 1
0167971 03/29/2001 OH 3.0 3 F 03/16/2001 02/02/2001, Redness and swelling at injection site on left deltoid. Seen in hospital ER on 2/3/01. Treated with Keflex and warm compresses. Y 02/01/2001 02/02/2001 1 NONE OTH PUB NONE NONE NONE 1
0167972 03/29/2001 OH 2.0 2 .6 F 03/22/2001 Left upper arm red, hot and swollen larger than golf ball, 24 hours, after DTAP injection. Y 03/08/2001 03/09/2001 1 NONE OTH PUB NONE NONE NONE 1
0167973 03/29/2001 OH 1.6 1 .5 M 03/15/2001 Redness and swelling at injection site. Y 02/02/2001 02/03/2001 1 NONE PUB OTH 1
0167974 03/29/2001 OH 1.5 1 .5 F 03/23/2001 Left thigh was red and swollen. Pt had a temperature of 103F. Treated with warm compresses and Motrin. Y 02/15/2001 02/15/2001 0 NONE OTH PUB NONE NONE NONE 1
0167975 03/29/2001 ID 0.3 0 .4 M 03/13/2001 Pt had a possible seizure the following morning post vax. Duration of 5 - 10 seconds. Y 01/12/2001 01/13/2001 1 NONE MIL MIL Tylenol NONE NONE 1
0167977 03/29/2001 CA 11.0 11 M 03/05/2001 Soreness, redness, swelling at injection site X 3 days. Treated with Advil and cold compress. Assessed by RN on day 3-appears resolving. Y 02/27/2001 02/28/2001 1 NONE PUB PUB NONE NONE NONE CA010023 1
0167978 03/29/2001 NY 42.0 42 F 03/23/2001 Pt complained of nausea and increased temperature. Seen by doctor in ER. Y U 03/21/2001 03/22/2001 1 CBC; Blood cultures X 2; SMA7 PVT UNK Rabies Immunoglobulin/R09034/IM/GM 1
0167979 03/29/2001 PA 6.0 1 .0 F 03/23/2001 Mom called on 3/23/01 and stated child has pimple-like fluid fill blisters over body and is itchy. Y 08/10/1995 03/23/2001 2052 NONE PVT PUB NONE NONE NONE 1
0167980 03/29/2001 SC 28.0 28 M 03/23/2001 Pt received vaccines at 11:30 on 3/20/00. Pt then experienced subjective high fever in early hours of 03/21/01; accompanied by chills, sweats and weakness. Pt described induration from IPV/YF/SC injections at about the size of a quarter each. Pt's fever (subjective) came down and induration decreased as the day went on and denies taking ibuprofen. Y 03/20/2001 03/21/2001 1 NONE PVT PVT NONE NONE NONE 1
0167981 03/29/2001 PA 4.0 4 M 02/21/2001 Pt experienced left arm swelling with cellulitis and returned to physician. Pt was treated with Augmentin, Benadryl, and Motrin. Y 02/12/2001 02/13/2001 1 PVT PUB NONE NONE NONE PA0122 1
0167982 03/29/2001 PA 45.0 44 F 02/15/2001 Client was symptom-free of fibromyalgia prior to 1st Hep-B immunization (per client) after Hep-B, symptoms of fibromyalgia worse for 1 weeks. Being "worked up" for possible Multiple Sclerosis at time of conversation. Y 08/31/2000 09/02/2000 2 NONE PUB PUB Prozac NONE Fibromyalgia PA0124 1
0167983 03/29/2001 PA 6.0 6 F 02/23/2001 24 hours post vax, the pt developed a reddened area the size of a golf ball that was sore. On 2/23/01 the child was brought into the state health center because the private physician could not see the child until the following week. The pt had a temp of 98.8. Acetaminophen and fluids were advised. On 2/27/01 the mother reports the the pt has a dry wheezing cough that occurs occasionally now. Y 02/21/2001 02/22/2001 1 PUB PUB NONE NONE PA0126 1
0167985 03/29/2001 KS 36.0 36 M 01/11/2001 Subsequent to receiving vax, the pt experienced elevated blood pressure and heart palpitations. Additional information received from the reporter on 12/28/2000 stated that the pt also experienced achiness, mild fever and tenderness at the injection site. The pt was monitored in the ER until his blood pressure returned to normal. The reporter stated that Hib-Titer was administered in place of HBIG. The pt recovered. Y Y 11/02/2000 11/02/2000 0 NONE MIL MIL UNK NONE UNK HQ3330207NOV2000 1
0167986 03/29/2001 CT 1.25 1 .3 M 12/28/2000 Within minutes post vax, the pt developed a 3 cm area of hives at the injection site. The hives resolved. The injection site then became warm and tender for 36 hours. He recovered. The reporter indicated that the pt had previously tested negative for allergies to egg and gelatin. Y 08/18/2000 08/18/2000 0 UNK PVT OTH NONE NONE UNK HQ0628605SEP2000 1
0167987 03/29/2001 IL U 12/15/2000 Within 24 to 48 hours post vax, the pt developed a 50 cent piece sized area of redness at the injection site. The reporter indicated that 2 pts experienced this event, however, only 1 is presently identifiable. As additional report will be generated when identifying information is provided. The lot number was reported as 471-869; however, this is not a valid Lederle lot number. U UNK PVT OTH UNK UNK UNK HQ1986710OCT2000 1
0167988 03/29/2001 IL 1.25 1 .3 F 12/27/2000 Two days post vax, the pt developed an injection site reaction which the reporter did not characterize. That same day the pt was seen by a physician. U 10/02/2000 10/04/2000 2 UNK OTH OTH UNK UNK UNK HQ3360808NOV2000 1
0167989 03/29/2001 IL 1.25 1 .3 F 12/27/2000 One day post vax the pt developed an injection site reaction characterized by an area of redness measuring 2 inches by 1 inch and a lump at the site of injection. U 09/28/2000 09/29/2000 1 UNK OTH OTH UNK UNK UNK HQ3370208NOV2000 1
0167990 03/30/2001 CT U 12/14/2000 A physician reported that a patient received 3 doses of Hib-Titer and died from "H. Influenza meningitis". The physician declined to provide additional information. Y N UNK PVT PVT UNK UNK UNK HQ4792613DEC2000 1
0167991 03/30/2001 TX 0.5 0 .5 F 12/29/2000 A pharmacist reported that a female received Hib-Titer vaccine at the ages of 2, 5 and 6 months. On 11/23/00, the pt (then 10 months of age) was hospitalized. A dx of haemophilus B influenza was made. She was treated with ceftriaxone. The lot number for the 1st dose of Hib-Titer administered on 3/13/00 was reported as 560906; however, this is not a valid Lederle lot number. Follow-up information received on 12/22/00, indicated that the pt was hospitalized for 10 days. Further follow-up received on 05/17/2001 indicated that the pt recovered. Y 10 Y 07/24/2000 11/23/2000 122 Blood cultures-positive for haemophilus B influenza; repeat blood cultures done on 11/27/00-neg OTH OTH UNK UNK UNK HQ4323801DEC2000 1
0167995 03/30/2001 MA 2.0 2 1 M 03/20/2001 This patient developed a seizure disorder, consisting of eyes opening and closing, rhythmical shaking (1 min), deep sleep (5-10 min), bit his tongue, multiple drop attacks, jerking, head falls forward, loss of consciousness, stiffening. It could be possible Doose's Syndrome which occurs in children normal or mildly delayed development. On 12/19/00, the patient had a Prevnar injection. 12/21/00, fever of 102. 12/21 - 12/22/00, given children's Tylenol 4-5 times. 12/22-12/24/00, traveled by car to New York with his family. 12/24/12/25/00, the mother had a bug, throwing up and diarrhea. 12/00 - 12/31, sinus congestion. 12/25/00, 4:20 PM, had first seizure, whole body. Eyes initially open with movement. Limbs, torso and jaw all tight with some shaking. About 1 minute in length. Deep sleep for 5-10 minutes afterward. Ambulance to hospital ER. Few hour observation and back home. 12/25/00, 9:00 PM, second seizure. Not quite severe as the first. Still close to a minute. Ambulance to the hospital ER. 12/26/00, 1:00 AM, third seizure in the hospital ER dept, given Ativan. Same day at , 4:00 AM, CT Scan. He had a fourth seizure while being moved from the ER dept to pediatrics; given Dilantin IV, also started on Depakote sprinkles. He was still having "mini seizures" a few times. Kind of like a momentary black out or twitch or grunt. On 12/27/00, at 3:00 PM, He had his fifth seizure. 3 hours after leaving the hospital. Shortly after waking up in back seat of the car, less than 30 seconds. Not as severe as the others, probably due to medication ramping up. Back to the hospital in an ambulance. They gave him Depakote IV at 6 PM, totaling 6 times. On 12/28/00, the hospital increased the Depakote sprinkles, the last Depakote IV was at midnight. On 12/29/00, He was given Glycerin suppository and discharged from the hospital with a fleet enema to take at home that night (it did the trick). 01/04/01, 4:30 PM, he had his 6th seizure for 1-2 minutes went to the hospital started on more meds. Y Y N 12/19/2000 12/25/2000 6 CT scan-nml; 1/01 had MRI-nml; EEG-showed paroxysmal generalized discharges, predominantly frontal, that did not correlate with any clinical spells. PVT PUB NONE NONE NONE 1
0167996 03/30/2001 TX 0.3 0 .4 F 03/14/2001 On 3/14/01, mother called and said child had a temperature of 103F and increased crying through the night. No local symptoms. This lasted about 8 hours. At 08:30, the mother was instructed to start Tylenol. At 11:30, per call, baby had a normal temperature and activity was normal. Marked chart and IZ record to hold pertussis due to possible allergy. Y 03/13/2001 03/14/2001 1 NONE PUB PUB NONE NONE NONE 1
0167997 03/30/2001 IA 1.25 1 .2 F 03/13/2001 Broke out in blisters approx. 5-7 days, post vax. "Thought she had a low-grade fever". Y 01/02/2001 01/07/2001 5 NONE PUB UNK NONE NONE 1
0167998 03/30/2001 AZ 1.75 1 .8 M 03/28/2001 Hives on trunk and arms. Y Y 03/27/2001 03/27/2001 0 PVT PVT NONE NONE NONE 1
0167999 03/30/2001 FL 1.3 1 .3 F 03/14/2001 2 days, post vax, pt had seizure-like symptoms with rolling back of eyes and shaking of upper and lower extremities. Y Y 03/07/2001 03/09/2001 2 CBC; LP; Blood cultures and scheduled EEG. PVT PVT NONE NONE 1
0168000 03/30/2001 IA 0.2 0 .2 M 03/29/2001 45 minutes of screaming uncontrollably the evening of the injection. Doctor suspects Prevnar vaccine. Y Y 01/25/2001 01/25/2001 0 PVT PVT NONE NONE 1
0168001 03/30/2001 IA 0.2 0 .2 F 03/29/2001 1 hour of high-pitched screaming and slight fever. Area of injection of Prevnar was red, swollen and tender. Doctor suspects Prevnar. Y Y 02/02/2001 02/02/2001 0 PVT PVT NONE NONE 1
0168002 03/30/2001 LA 0.3 0 .3 F 02/23/2001 Brought in by parent to Peds ER on 2/23/01 complaining of rash at injection site. Received shot on Tuesday. Y U 02/20/2001 02/22/2001 2 PUB OTH NONE NONE NONE 1
0168003 03/30/2001 PA 61.0 60 M 03/10/2001 Pt experienced joint pain and fatigue. Pt is unable to sleep at night and/or exercise from joint pain. 03/03/2000 04/30/2000 58 PVT OTH 1
0168004 03/30/2001 MD 81.0 79 F Both arms are painful and weakened at shoulder and top. Pt is undergoing therapy. Y 12/01/1999 PUB UNK 1
0168005 03/30/2001 VA 34.0 34 F 03/08/2001 The pt felt weak, hot and short of breath, numbness in the hands and feet. Shallow breathing, O2 given. Pt cold and shaking. Epipen given IM. Paramedics came at 11:00 am. EKG normal, pt calming down. 12:00 pt was relaxed and asleep. Y 01/19/2001 01/19/2001 0 PVT PVT Nystatin, Diflucan, Thyroid 1
0168006 03/30/2001 GA 5.0 5 F 03/28/2001 Pt was seen 3 days post vax by a physician with 6.5 X 9 " area of redness, induration over left thigh with central 1" X .5" blister. Pt was treated with antibiotics. Y N 03/14/2001 03/15/2001 1 NONE PVT PVT NONE NONE NONE 1
0168007 03/30/2001 NJ 6.0 6 F 02/26/2001 This child had irritability after the immunization, also sore throat, left ear pain, rash to both arms and legs. On 02/25/01, excessive gas, diarrhea, temp less than or equal to 100 degrees rectally, fatigue, abdominal pain, dysgeusia. Y Y 02/22/2001 02/22/2001 0 PVT PVT Mild allergic rhinitis 1
0168008 03/30/2001 NC 4.0 4 F The pt experienced erythema, edema and pain at the injection site. Y Y 02/07/2001 02/09/2001 2 PVT PUB NC01026 1
0168009 03/30/2001 NY 38.0 39 F 03/07/2001 The pt experienced painful, soft tissue swelling to the left arm at the injection site / deltoid muscle with redness of skin which was 5cm. No fever. Y U 02/27/2001 03/02/2001 3 NONE PUB PUB NONE NONE 1
0168010 03/30/2001 NY 11.0 6 F 03/12/2001 Pt developed attenuated varicella disease with approximately 15 lesions on 03/10/2001 Y 08/30/1996 03/10/2001 1653 PVT OTH UNK UNK UNK 1
0168011 03/30/2001 TX 0.3 0 .2 F 03/14/2001 The mother states the pt cried all day and all night, and experienced a low grade temp. Y 01/10/2001 01/10/2001 0 NONE OTH OTH Rhondec nasal congestion nasal congestion 1
0168012 04/02/2001 NH 0.2 0 .2 M 03/10/2001 This patient died on 12/07/01. He went to the ER pulseless, no respiratory effort, no response to resuscitative efforts. The coroner unofficial report- SIDS. Autopsy states cause of death as SIDS. Y 12/07/2000 N 12/04/2000 12/07/2000 3 PH-6.29 PVT PUB NONE NONE NONE 1
0168013 04/02/2001 IL 0.3 0 .4 F 03/22/2001 Cough started 2/21/01. Vomiting phlegm the weekend before 3/3/01 and 3/04/01 crying with no tears. She was eating and had no fever. Stool very runny. Saw doctor on 3/1/01. She lost 5 oz from 2/13/01 to 3/01/01. Doctor found nothing wrong. Autopsy states cause of death as sudden infant death syndrome. Y 03/06/2001 Y N 02/21/2001 02/21/2001 0 PUB PUB NONE NONE NONE 1
0168014 04/02/2001 IN 0.2 0 .2 M 03/18/2001 SIDS Y 01/06/2001 N 01/05/2001 01/06/2001 1 PUB PUB NONE NONE NONE 1
0168016 04/02/2001 FL 31.0 31 F 03/29/2001 On 3/13/01, pt given Tetanus Toxoid at another facility after scratching leg. Next day, she complained of flu-like symptoms, aches, body stiffness, fever of 102F. On 3/15/00, went back to original facility and was given Benadryl, Toradol and cortisone. Symptoms continued including pain, seizure, difficulty moving, SOB and swollen lips, tongue and face. Presented to our hospital complaining of above symptoms. Pt now claims she had the same reaction 7 years ago. Not given at out facility. Diagnosed with allergic reaction, myopathy, rhabdomyalsis Y Y Y Y 03/13/2001 03/14/2001 1 3/20/01 Complement C3=131, C4=34.6; RA (-); ANA (-) PVT UNK 1
0168017 04/02/2001 IN 1.2 1 .2 M 03/10/2001 Gradual onset of symptoms of severe diarrhea after his MMR in 4/94, including screaming at night, not sleeping, preoccupation of an object, loss of language and has never regained any speech and is now 8 years old. He has had dx and evaluations by local doctors and pediatric neurologists as well as specialists. Has stopped shots. The 60 day follow-up reports states the baby lost all of speech and has never regained any of it. In addition to this, the baby has a significant issue of gut problem and a metal metabolism. Dysfunction (zinc, copper imbalance). He also has a lot of mercury in his body as well as aluuminum, lead, etc. Doc 212155, annual follow up, states the following: autistic symptoms, nearly as severe as ever. No speech, uncontrollable behavior, no appropriate play. Doc also states that metal level in body coming down. Follow up letter states: Sending a copy of your letter back tou you to help you recall our situation. Sorry it took so long to reply. However MD is aware of his being called. Pt has been to the center one time and it is at the center that we found out he has a M/T dysfunction (mental metabolism dysfunction) and he is now taking nutritional therapy which is being compounded at their pharmacy. MD is working with another MD at center regarding pt. I hope this will help you. If you have further questions please call. Y N 04/07/1994 Cat Scans, Spect Scans, MRI's; 24 hour sleep EEG; 24 hour Digitrace Tests, Myelin sheath basic protein analysis antibody test;Neuronaxon filament proteins antibody test; Serotonin test, Gluten sensitivity test; organic acids interpretation; blood cell element reports, hair analysis; heavy metal toxicity analysis; Thrombofilia test PVT PVT NONE NONE Seizure disorder, bowel brain malfunction, food allergy, auto-immunity (MRI showed abnormal vascularzation in the left temporal lobe). He has had 6 IV IG infusions. 1
0168018 04/02/2001 OH 33.0 23 M 03/02/2001 After 1st Anthrax, sought treatment on 1/11/91. On 1/21/91, I returned to the Medical Aid Station still complaining of throbbing pain in the lower left back to left testicle. On 1/22/91, I returned again, with lower left back pain and abdominal cramping. During the exam, the prostate felt burning on palpation and was boggy, 2-3cm. I was to return for a follow-up in 7 days. On 1/29/91, I received the Anthrax 2 vaccine. The next day, I returned for a follow-up. Doxycycline (known treatment for the side affects of P. B. pills and the Persian Gulf Syndrome) was still continued for 14 days. When each 1 of these exposures (Anthrax, environmental chemicals, warfare and P. B. pills) are administered individually, the toxicity levels have been reported to be bad enough! Being exposed to these exposures within a 3 week time span (exposure to some for longer periods), can reportedly multiply the toxicity level 25 to 35 times more! Given the known side affects of some exposures and the unknown long term affects of other exposures, combined with a cocktail of all these exposures, I feel it is safe to say that I acquired an unknown illness/Persian Gulf Syndrome! Dx's given in the past were just actual symptoms of an unknown illness/Persian Gulf Syndrome. The unknown illness/Persian Gulf Syndrome is a probable result of a series of exposures that I was exposed to, that have very little or no data on side affects, thus Undiagnosed Illness. I feel that I should be awarded 100% Service Connection since 4/3/98, when the MD signed a set of severe limitations in which he indicated that I was unable to do 98% of the physical requirements of my job, which eventually led to the termination of my job!. This is my complete statement of what happened to me. I have documentation to uphold this statement! Have been seeking treatment from VA since 10/96 until the present and ongoing treatment. A follow up report received 04/11/2001 adds: (Current symptoms:) Numbness in fingers and toes, muscle cramps and spasms, muscle aches, joint pain and discomfort, back pain with lower back pain dominant, headaches, fatigue, sensitivity to light, abdominal cramps, chronic diarrhea and occasional burning sensation while urinating. Y Y Y N 01/29/1991 MIL MIL Motrin Nausea, Diarrhea, chest pain, light headed, urinating blood. NONE 1
0168019 04/02/2001 CA 35.0 35 F On 9/14/00 had hives and chickenpox from vaccines, especially on lips. On 10/10/00, had persistent hives, joint stiffness, treated with Decadron and Depo-Medrol. On 10/13/00, was give prednisone. On 11/16/00, continued with hives, especially on face. On 1/09/01, had hives all over and was treated with Decadron and Depo-Medrol. Doc 215203 states the following: "I have called x2 & not received a return reply to my message. Spouse answered phone but was unaware of any problems associated with the 12's. Y N 08/30/2000 08/30/2000 0 PUB PVT NONE NONE NONE 1
0168021 04/02/2001 WV 53.0 53 M 03/07/2001 This patient lost sight in his left eye. (Nothing else attached). The follow up received on 7/3/01 states, "this is a 53 year old pt who was referred by Dr, to "try to help me." "I'm losing my vision; I basically lost my vision in my left eye." "I first noticed the loss of vision on January 5, I took the flu shot about 2:00 in the afternoon, and about 7:30 or 8:00, I went down to read a book and it was fuzzy." He checked the eyes individually and found that the fuzziness was only OS. When he awoke the next morning, it was still fuzzy. The same morning, Saturday, January 6, he was seen by Dr, an optometrist. "She basically said I needed to go see an ophthalmologist." It sounds like he was told that he had AION. On Monday, January 8, he was seen by Dr and "he basically told me I had the same problem but he wanted to go ahead and run various blood tests and an MRI." The MRI scan was done on January 9. "It was all good except he had sinusitis." "I didn't have any vision in the upper half." "This past Sunday (1/14), it started in the lower half, and since then it's just about to the point where it's all gone." "There is a mild swelling-like or puffy-like sensation." There has been no real pain; no pain on motility. "In driving down here yesterday, there was a lot of strain on it." "It just feels like your eye is weak, it's worn out, you just want to close it." "There has been no problem with vision OD. He has had some mild hypertension. "It's high when I first have it tested, but by the time I leave the office, it's down to around 140/90." Four days ago he was started on Norvasc. There is no history of diabetes, ASCVD, angina, MI, CVA, focal motor weakness, or cigarette consumption. He has been on Decadron for 2 years for "Meniere's disease." There was no prior MRI scan." Y N 01/05/2001 01/05/2001 0 OTH UNK 1
0168022 04/02/2001 NC 1.25 1 .4 M 03/12/2001 This child's fever was up to 101 F for 5 days and sleeplessness after receiving Prevnar dose # 1 and DTaP dose #4, on 11/16/00. Y 11/16/2000 11/16/2000 0 NONE PVT OTH NONE NONE NONE 1
0168023 04/02/2001 MI 1.37 1 .4 M 03/12/2001 The right leg has elevated erythema, induration, heat, pain, and some surrounding urticaria. Y Y 02/26/2001 02/28/2001 2 PVT PVT Foriole NONE NONE 1
0168024 04/02/2001 CA 0.5 0 .4 U On 11/13/00, this patient received: DTaP, Comvax, IPV, and Prevnar. On 01/01, the mother noticed poor eye contact, decreased appetite, spasticity mostly in lower extremities, progressive development delay. Y U 11/13/2000 01/02/2001 50 Torch, TSH, T4, CBC, Chem, MRI. PVT PVT Healthy NONE 1
0168025 04/02/2001 OH 31.0 31 F 03/21/2001 2 1/4 inch by 1 1/4 inch, red raised area, on the right arm. The area was elongated; slightly tender to touch; no fever. Follow up: Patient has partially recovered from adverse event. There is still a lump and bruise on arm. However, there aren't and never were septemic symptoms. Patient never missed work. Patient has been evaluated by a physician or health care provider. Patient did not receive any more shots since reported event." Y 03/20/2001 03/21/2001 1 OTH MIL Ibuprofen 1
0168026 04/02/2001 AR 55.0 55 F 01/17/2001 This patient received the flu shot on 12/20/00. No elevated discomfort at the time of the injection. Within 24 hours, the patient experienced alot of discomfort in the deltoid to elbow region. Discomfort limits range of motion at times. The patient did not have fever at anytime, but discomfort persists. The patient took Tylenol one time with some measure of relief. No redness or induration noted at the left deltoid area. The patient referred to the PMD for evaluation. Y U 12/20/2000 12/21/2000 1 Pending MD visit. OTH PUB HRT NONE Hep C AR1801 1
0168027 04/02/2001 IA 73.0 72 M 03/15/2001 This patient received a flu shot on 12/28/00. He presented 01/22/01 to the clinic with history of 4 weeks of left arm edema which started after the flu shot. He had edema in the arm after the flu shot 2 years prior but also cleared on its own. This time it didn't. He underwent CT Scan, and venogram to r/o DVT or a mass effect causing lymphadenoma; all were negative. Arm still very swollen. N 12/28/2000 12/30/2000 2 Thoracic CT, Left arm venogram, - All Neg. PVT PVT Prevacid, Synthroid, Catapress, Bumex, Wellbutrin, Lotensin, ASA, Paxil, Norvasc, Combivent Allergic to Penicillin, Sulfa, Cipro, Morphine, Ceclor. Diabetic type II, Hypothyroidism, CAD, COPD, Diabetic neuropathy, BPH, Hypertension, Hiatal hernia, depression / anxiety, Paroxysmal atrial fibrillation, CHF-stable, Nephrosclerosis, S/P AAA repair, DVT, PE, CABG, umbilical hernia repair, Cholecystectomy, Small bowel obstruction, GI bleed. 1
0168028 04/02/2001 MI 21.0 21 F 12/06/2000 Severe Pain at the injection site on the left arm. The arm was warm to touch. Vitals were taken at 1:45 PM as followed Temp 97.4, P 84, R 16, B/P 72/60. On 12/11/00, per phone call; the patient complained of generalized swelling of the upper arm. On 12/06/00 she had a temp of 101 F for 2 days with pain at the injection site. On 12/05/00 she had itching for 1 1/2 days after the injection. No additional medical follow up. Treatment of cool compresses and Ibuprofen taken by the patient. Presently feeling much better. Enc medical care if needed. In later October 2000, the patient was diagnosed and hospitalized with Influenza. Complained of weakness, elevated temp, and a sore throat. Treated with antibiotics names unknown. Y 12/05/2000 12/05/2000 0 PUB PUB Prednisone Congenital adrenal hyperplasia, allergy to acetaminophen and Penicillin. no data~Influenza (Seasonal) (no brand name)~1~21.00~In Patient MI2001021 1
0168029 04/02/2001 CA 2.0 2 .2 F 03/28/2001 This child had large local redness, and swelling at the site of the injection 4" x 3". Y Y 03/26/2001 03/28/2001 2 NONE PVT UNK Conjunctivitis NONE 1
0168030 04/02/2001 IL 38.0 37 M Within 6 hours of the injection, this patient's left TMJ became stiff, and extremely painful. The pain lasted 48 hours then resolved. Y Y 01/30/2001 01/30/2001 0 PUB PVT TB test NONE NONE 1
0168031 04/02/2001 DE 36.0 36 F 03/26/2001 On 03/20/01 PM, the patient had chills, shakes, afebrile, and bilateral numbness of hands. On 03/21/01, the patient had severe abdominal, chest pain, and nausea. On 03/22/01, the patient had a loss of consciousness, hypotension, swelling of her lips, and face. On 03/22/01, prescription of Prednisone given by Family MD. Y U 03/20/2001 03/20/2001 0 NONE OTH PVT Vioxx, Plaquenil. Mixed connective tissue disease. 1
0168032 04/02/2001 TN 1.5 1 .5 M 03/23/2001 Several hours after the Varicella vaccine, this infant woke up from a nap screaming. He had twitches as described by the mother and was crying. He did briefly stare at the ceiling. He never lost consciousness. He had trouble drinking fluids, this resolved after 1 hour and 45 minutes. Exam in office normal. Advil helped. Y Y 03/23/2001 03/23/2001 0 NONE PVT PVT Amoxicillin Otitis Media Eczema, Milk protein intolerance. 1
0168033 04/02/2001 WA 0.2 0 .2 F 03/22/2001 Per mother's report: 7 hours after immunizations were administered, the patient spiked a high fever and presented with red welts over her entire body to the ER. Y Y 01/11/2001 01/11/2001 0 PVT OTH NONE NONE NONE 1
0168034 04/02/2001 MD 1.5 1 .5 M 03/22/2001 The patients mother took him to the ER stating that the patient was breathing funny and his hands and feet turned blue. No respiratory distress in the ER. BBSH (-), Pulse 126, Resp 44, Pulse OX 97%. Diagnosis from ER was viral syndrome vs reaction to immunization. The patient did vomit one time in the ER and was fussy. The patient was given Tylenol and discharged on clear liquids for 24 hours. Y Y 03/20/2001 03/20/2001 0 PVT PUB NONE NONE NONE 1
0168035 04/02/2001 TX 4.0 6 M 03/01/2001 This patient had a swollen face, wheezing, respiratory distress after shots (4 year vaccines). Allergic reaction the same evening as the shots. He was taken to the ER and given Epinephrine with Benadryl and a steroid. Y Y 12/05/2000 12/05/2000 0 PVT PVT NONE Hay fever allergies - seasonal. 1
0168036 04/02/2001 NM 5.0 1 .2 F 03/22/2001 This child developed a mild chicken pox rash on 03/20/2001. No associated symptoms, no fever. the rash had increasing number of isolated, distinct erythematous macules or papules, some crusting vesicles, minimal. U 01/17/1997 03/20/2001 1523 NONE UNK UNK 1
0168037 04/02/2001 WA 19.0 19 M 03/08/2001 This patient's injection site was very red and slightly raised. Peripheral redness to the injection site with pain and numbness experienced in the limb from injection site down to the hand. Y Y 02/18/2001 03/19/2001 29 NONE OTH OTH NONE NONE 1
0168038 04/02/2001 NC 1.0 0 1 F This infants left leg was swollen and red. U 01/24/2001 01/26/2001 2 PVT PUB NONE NONE NONE 1
0168039 04/02/2001 WA 1 .4 M Mom noted swelling of arm in morning of 3/9/01. Left arm was red from elbow to shoulder and was swollen from mid-clavicle/mid-scapula to head. Circumference of arm at elbow 3.5cm larger than right arm. Y Y 03/08/2001 03/09/2001 1 NONE PVT PUB NONE NONE NONE 1
0168040 04/02/2001 MN 1.0 1 .1 M 02/22/2001 At 26 months the patient's mother called with complaints of chicken pox and would like Benadryl and calamine lotion . Y Y 05/21/1998 08/02/1999 438 PUB PUB Gentamiacin, Amoxicillin, Benadryl Conjunctivitis UNK WAES01031382 1
0168041 04/02/2001 MN 1.9 1 .2 F 02/22/2001 Historical date, not actually seen at our clinic for dx relayed to provider. On 7/20/00 at 14:40, in for well child check; Mom states no concerns today, other than pt got chickenpox about 2 weeks ago on 7/6/00. Recovered from chickenpox without problems. Has matting eyes every AM, resolving. No other upper respiratory symptoms. Prescribed Polytrim ophthalmic drops, Fluoride drops, Tylenol drops and chews. Y 09/30/1999 07/06/2000 280 NONE PUB PUB WAES01031379 1
0168042 04/02/2001 KS 1.3 1 .3 M 03/20/2001 On 3/16/01 at 19:30, mother noticed left thigh was swollen, red and hot. No fever. Child didn't demonstrate discomfort. Very active and didn't complain of leg pain. Was taken to ER because clinic was closed. ARNP saw client. Mother states the swelling was approx. 10cm. He was Rx'd antibiotic for 10 days. On 3/17/01, much improved next AM. Y Y 03/15/2001 03/16/2001 1 PUB PVT NONE NONE NONE 1
0168043 04/02/2001 OH 4.0 4 F 03/30/2001 03/28/01, injection site red and swelling. Full ROM. Cold compresses. On 3/29/01, treated with diphenhydramine 1 1/2 tsp every 6-8 hours. Y 03/27/2001 03/28/2001 1 NONE OTH PUB NONE 1
0168044 04/02/2001 WA 38.0 38 M 12/12/2000 Soreness, pain at injection site, low stamina, vertigo, tiredness. Has a history of middle ear problems and vertigo but felt got much worse after TD on 12/7/00. Y U 12/07/2000 12/07/2000 0 PUB PUB Celax NONE Middle ear problems; mental health problems WA011718 1
0168045 04/02/2001 WI 1.5 1 .6 F 03/26/2001 Right upper leg swollen, hot to touch, itchy and painful. Y Y 03/19/2001 03/20/2001 1 PVT PVT NONE NONE 1
0168046 04/02/2001 CA 2.5 2 .6 F 03/15/2001 Size of baseball Y U 03/09/2001 03/11/2001 2 PVT PVT NONE NONE 1
0168047 04/02/2001 ME 51.0 50 F 03/02/2001 4" X 3" raised, red area, tender to touch over "biceps" of left arm which lasted 5 days. Y 02/05/2001 02/06/2001 1 NONE PUB PUB Paxil, Premarin, Prevacid, Zocor, Synthroid, Lorazepam, Provera Hypothyroidism, Depression, Anxiety ME01008 1
0168048 04/02/2001 ME 47.0 47 F 03/02/2001 Large local reaction, 4" X 3" area, red, hot, swollen and tender. Y 02/05/2001 02/06/2001 1 PUB PUB NONE Hematuria; Kidney Stones; Flank pain Hypertension; headaches (migraines); Left adrenal mass ME01009 1
0168049 04/02/2001 FL 1.25 1 .3 F 02/21/2001 Red area about 4cm on left thigh, small bump with clear drainage. No fever. Treated with Bactroban cream tid X 5 days, warm compresses and massage. Y Y 02/20/2001 02/20/2001 0 Viral and bacterial skin cultures done PUB OTH NONE FL01008 1
0168050 04/02/2001 FL 9.0 8 F 03/12/2001 On 2/27/01, was given varivax/SC (R0 LTR about noon. Mother noticed redness and swelling about 15:00 and was getting larger today (02/28/01) and painful. Wt 60 1/2 lbs; T-101F. Redness and swelling 6cm in diameter, center swelling and discolor 2cm, feels warm to touch. Advised children's Motrin for fever; cold compress and Benadryl elixir 25mg every 4-6 hours. Recheck tomorrow but if worsens go to ER. On 3/12/01, swelling and redness were resolved. Y 02/27/2001 02/27/2001 0 PUB PUB NONE NONE FL01009 1
0168051 04/02/2001 FL 19.0 19 F 03/22/2001 Had Hep B #3, Tuesday 3/20/01. Woke up at 02:00 AM with vomiting and diarrhea. By morning, was vomiting blood and having bloody diarrhea. Pt went to ER. Dx'd with Gastroenteritis (mom stated It's a very contagious virus). Y Y 03/20/2001 03/21/2001 1 PUB UNK NONE NONE FL01010 1
0168053 04/02/2001 CA 0.4 0 .4 M 02/20/2001 A medical assistant reported that a 5 month old male who was being treated for a bronchial infection with an unspecified medication via nebulizer since 1/7/01, received his 3rd dose of Prevnar on 1/18/01. On 1/23/01, he was admitted to the hospital with a dx of bronchiolitis. On 1/27/01, he was discharged. Y 5 U 01/18/2001 01/23/2001 5 UNK PVT OTH UNK Bronchial infection UNK HQ7276815FEB2001 1
0168054 04/02/2001 FL 1.5 1 .5 F 02/21/2001 A physician reported that a female child received Prevnar and TriHibit vaccines and subsequently, she developed a fever, stridor and retractions. The child was hospitalized and dx'd with croup. She also developed an injection site reaction characterized by redness and swelling. The specific sites of vaccine administration were not reported. The child recovered. Y Y 01/04/2001 01/04/2001 0 X-ray-showed "ballooning" of her hypopharynx OTH OTH UNK UNK UNK HQ7411920FEB2001 1
0168056 04/02/2001 NC 1.0 0 .9 M 02/26/2001 The pt was hospitalized with suspected pneumococcal infection one month post vax. Follow-up information received on 2/26/01 from the child's physician indicated that the male child was immunized on 11/28/00. On 1/19/01, the child was hospitalized for a pneumococcal infection. A blood culture revealed the presence of Streptococcus pneumonia with resistance to PCN and cefotaxime. The child was hospitalized for 13 days and has since recovered. Y Y 11/27/2000 01/28/2001 62 blood culture - streptococcus pneumonia present PVT OTH UNK NONE UNK HQ6775302FEB2001 1
0168057 04/02/2001 TN 0.6 F 12/15/2000 A territory representative reported that a 7 month old female received her 2nd dose of Prevnar and subsequently was diagnosed with Streptococcus Pneumoniae bacteremia. No further information was available at the date of this report. Streptococcal septicemia is considered medically important. U UNK OTH OTH UNK UNK UNK HQ4698311DEC2000 1
0168058 04/02/2001 U 01/12/2001 Subsequent to receiving vax, the pt experienced a seizure. As of 01/09/2001, no further information was available. The reporter declined to provide additional information and declined to grant permission for follow-up investigation. U UNK OTH OTH UNK UNK UNK HQ5818111JAN2001 1
0168059 04/02/2001 MA 1.25 U 02/09/2001 A territory representative reported that a 15 month old child received a 2nd dose of Prevnar and subsequently developed Pneumococcal bacteremia, serotype unknown. No further info was available at the date of this report. Streptococcal septicemia is considered medically important. Follow up data received from the physician on 03/20/2001 indicated the patient received Prevnar and Engerix-B vaccines on 08/14/2000. A blood culture was positive for Streptococcus pneumoniae. The patient recovered. Y UNK OTH OTH UNK UNK UNK HQ6996208FEB2001 1
0168060 04/02/2001 TX 0.2 0 .2 F 02/26/2001 A physician reported that her 2 month old daughter received her 1st dose of Prevnar, Comvax, IPV, and DTaP vaccines in January, 2001. On 02/20/01, she was treated and released from the ER for a seizure and high fever. As of 02/22/01, she continued to receive treatment with Ceftriaxone. Seizures are considered medically important. Copies of this report have been forwarded to Merck and Aventis Pasteur, manufacturers of the concomitantly administered vaccines. Follow up received from the patient's pediatrician on 04/17/2001 indicated the vaccines were administered 02/08/2001 and she was seen in the emergency room 02/21/2001. The patient recovered. Y Y 02/08/2001 02/10/2001 2 NONE PVT OTH NONE NONE UNK HQ7598223FEB2001 1
0168062 04/02/2001 CA 0.2 0 .2 M 02/13/2001 Shortly after receiving vax, the pt developed a flaky red rash on his face and arms. Additional information received 02/07/2001 from the physician indicated that the pt developed a dry scaly rash on his scalp, face, chest and arms. A diagnosis of cradle cap or seborrhea was made. The pt recovered. Y 10/05/2000 UNK PVT OTH NONE NONE UNK HQ4659408DEC2000 1
0168063 04/02/2001 MD 1.25 1 .3 M 03/15/2001 Within one week subsequent to receiving vax, the pt developed a fever of 102 degrees F, enlarged lymph nodes on the right side of his groin, and an injection site reaction characterized by swelling and pain. The child also experienced minimal upper respiratory symptoms and superficial ecchymosis. On 11/24/2000 the pt developed a fever of 105 degrees F and had a clear nasal discharge, moderately enlarged tonsils, and a macular reticular rash on his face and chest. On 12/05/2000, the pt developed hives for which he was treated with Benadryl. The following day, a diagnosis of bronchitis was made and Zithromax therapy was initiated. This report is one of 3 cases of injection site reactions secondary to the same lot of Prevnar reported from the same institution. Follow-up information indicated that on pt also received the third dose of Recombivax-HB vaccine. The pt first experienced fever, ecchymosis, enlarged lymph nodes, and the injection site reactions on 11/21/2000. The pt has recovered. A copy of this report has been forwarded to Merck. Y Y 11/17/2000 11/21/2000 4 PVT PVT UNK NONE UNK HQ4692111DEC2000 1
0168064 04/02/2001 NJ 0.6 F 01/08/2001 One day post vax, the pt developed nasal congestion. As of 12/08/2000, the nasal congestion had not resolved. U 09/27/2000 UNK PVT PVT NONE NONE UNK HQ4756312DEC2000 1
0168066 04/02/2001 IL 1.5 M 01/10/2001 Subsequent to receiving vax, the pt was seen by a dermatologist and a diagnosis of erythema multiforme was made. Titers were drawn to rule out any infections or other causes. U 10/24/2000 UNK PVT OTH NONE cold UNK HQ4868114DEC2000 1
0168067 04/02/2001 MA 1.5 1 .5 M 01/25/2001 A nurse reported that an 18 month old male received his 1st dose of Prevnar, as well as, IPV on 9/20/00 and 7 days later, developed an entire body blisters (zoster-type lesions). The pt was referred to a dermatologist and treated with alclometasone dipropionate. Additional information received on 1/23/01 included tests results. U 09/20/2000 09/27/2000 7 IgG-498; IgA-29; IgM-95; Electrolytes were nml; WBC-8.6; Hemoglobin-12.5 with hematocrit-36.7; Platelet count-290. PVT OTH NONE NONE UNK HQ4936315DEC2000 1
0168068 04/02/2001 NJ 4.0 4 F 01/26/2001 A mother who is also a nurse, reported that her 4 year old daughter received an injection of Prevnar on 12/12/00 and 2 nights later, awakened complaining of "shivers" but denied being cold. Her mother noted intermittent, involuntary jerking motions of her daughter's body. The mother reported that her daughter was afebrile, alert and oriented. Her symptoms resolved approx. 6 hours later. Additional information received on 1/25/01, from the physician indicated that the pt has had no subsequent jerky movements or episodes of altered awareness. Y 12/12/2000 12/14/2000 2 UNK OTH OTH NONE UNK UNK HQ4946115DEC2000 1
0168069 04/02/2001 FL 2.0 U 01/15/2001 A sales representative reported that a 2 year old child received 2 doses of Prevnar and had pre and post vax sero-types drawn. Titers showed no level of response. The pt's medical history indicated that the child is "highly resistant to strep pneumonia". As of 12/15/00, no further information was available. U UNK OTH OTH UNK UNK UNK HQ5057419DEC2000 1
0168070 04/02/2001 WI U A healthcare professional reported that a pt received Prevnar and experienced an unspecified reaction. No further information was available at the date of this report. The reporter was unable to specify the number of pts who experienced this event. Additional reports will be generated when identifying information is provided. U UNK OTH OTH UNK UNK UNK HQ5146521DEC2000 1
0168071 04/02/2001 MA 1.25 1 .3 M 01/11/2001 A mother reported that her 15 month old son with a history of "reflux" received Prevnar and Hib vaccines on 12/18/00 and subsequently, vomited in the physician's office. Later that day, he vomited and slept for an unusually long time. He developed a low-grade fever, rapid breathing and he was fussy. On 12/19/00, the fever resolved. He then developed an injection site reaction characterized by redness and swelling at the site of the Prevnar injection. He was treated with diphenhydramine. On 12/20/00, his breathing was improved. U 12/18/2000 12/18/2000 0 UNK PVT OTH Zantac NONE Gastroesophageal reflux disease HQ5174821DEC2000 1
0168072 04/02/2001 PA 1.0 1 .0 M 09/13/2001 A mother reported that her 12 month old son received Prevnar and MMR on 12/8/00. On 12/15/00, he experienced irritability and crying. Additional information received from the physician on 1/17/01, indicated that the pt was seen in the physician's office on 12/19/00 where a physical exam was normal. Follow up info was received from the center for biologics evaluation and research on 09/04/2001. The child received his second dose of Prevnar and his first dose of MMR vaccines on 12/08/2000. On 12/15/2000, he experienced insomnia. Y U 12/08/2000 12/15/2000 7 Physicial exam-nml PVT PVT NONE NONE UNK Irritability and crying~Pneumo (Prevnar)~1~0.00~In Patient WAES01010939 1
0168073 04/02/2001 WI 0.75 0 .8 F 01/26/2001 A territory representative reported that a 9 month old female received an injection of Prevnar on 12/20/00. Approx. 24 hours, post vax, she developed an injection site reaction characterized by hives and induration. On 12/22/00, the reaction site measured 7cm X 5cm. Additional information received from the physician on 1/25/01, indicated that the dose of Prevnar may have been inadvertently, administered subcutaneously. She recovered. Y 12/20/2000 12/21/2000 1 NONE PVT OTH UNK NONE UNK HQ5249027DEC2000 1
0168074 04/02/2001 CA 1.25 1 .3 M 01/11/2001 A mother reported that her 15 month old son received his 3rd dose of Prevnar on 9/23/00. He developed a runny nose and was empirically treated with amoxicillin. On 12/20/00, he returned a positive throat culture for a strain of Streptococcus pneumonia that was "resistant to antibiotics". The serotype was not specified. He recovered. Y 09/23/2000 12/20/00; Culture throat-positive for Streptococcus pneumonia PVT OTH NONE NONE UNK HQ5480403JAN2001 1
0168075 04/02/2001 CT 2.0 2 .0 F 03/05/2001 A company representative reported that a 2 year old female received Prevnar vaccine and subsequently developed an allergic reaction including hives. She was treated with diphenhydramine (Benadryl) and recovered. The reporter noted that the pt was allergic to penicillin and cephalosporins. Follow up infomation was received from the physician on 03/05/2001 which identified the patient, date of vaccination and adverse event onset. Y 11/20/2000 UNK OTH OTH UNK UNK Drug hypersensitivity HQ5622208JAN2001 1
0168076 04/02/2001 PA 0.5 0 .5 M 01/08/2001 A nurse reported that a 6 month old male received his 1st dose of Prevnar on 5/3/00. Within 2-3 days, post vax, he developed a high fever, wheezing and shallow breathing. He recovered. Y 05/03/2000 UNK PVT PVT Zantac NONE UNK HQ5645408JAN2001 1
0168077 04/02/2001 PA 0.75 M 01/11/2001 A mother reported that her 9 month old son received his 1st dose of Prevnar and subsequently experienced irritability and crying. He recovered. Y UNK PVT PVT UNK UNK UNK HQ5674808JAN2001 1
0168078 04/02/2001 NY U 02/09/2001 A company representative reported that a child received an injection of Prevnar in 1/01. The next day, the child developed swollen eyes and was irritable, cranky, and "very" upset. No further information was available as of the date of this report. U 01/01/2001 UNK PVT OTH UNK UNK UNK HQ5924215JAN2001 1
0168079 04/02/2001 CA 2.0 2 .2 M 02/09/2001 A mother reported that her 26 month old son received his 1st dose of Prevnar in 10/00. Two weeks, post vax, he developed a high fever, abdominal gas, diarrhea and vomiting. The symptoms lasted 5 days. The reporter noted that the physician stated "this was flu, not related to Prevnar". Antibodies were checked 3 weeks, post vax, and reportedly, no antibody response was noted. The child has a history of ear and upper respiratory tract infections since he was 5 months old. Allergies have been ruled out by a blood test. Common variable Immune Deficiency Syndrome has been ruled out. IgA antibody tests were negative. Y 10/01/2000 10/14/2000 13 Drug specific antibody absent-no antibody response was noted PVT OTH NONE NONE Ear infections NOS; increased activity; Upper respiratory tract infection NOS HQ6085418JAN2001 1
0168080 04/02/2001 U 02/02/2001 Subsequent to receiving vax, the pt experienced and unevaluable reaction. It is unknown if the pt was taking concomitant therapy and medical history was not provided. The caller refused to provide any additional information and therefore, additional information is unattainable. U UNK OTH OTH UNK UNK UNK HQ6174119JAN2001 1
0168081 04/02/2001 NY M 02/20/2001 The pts parent reported that the pt had a very bad reaction following vaccination with Prevnar. The vaccine was given in the deltoid muscle along with another unspecified vaccine. U UNK OTH OTH UNK UNK UNK HQ6318924JAN2001 1
0168082 04/02/2001 CA 0.25 0 .3 M 01/29/2001 Subsequent to receiving vax, the pt developed a flaky red rash on his face and arms. U 11/02/2000 UNK PVT OTH NONE NONE UNK HQ6322324JAN2001 1
0168083 04/02/2001 OH 1.25 1 .3 F 02/15/2001 A nurse reported that a 15 month old female received injections of a 1st dose of Prevnar and a dose of Infanrix on 1/12/01. The pt had a "low-grade" fever of 99F (R), prior to receiving the vaccinations. Three to four hours, post vax, the pt experienced a fever, decreased appetite, drowsiness and nasal congestion. It was noted that the nasal congestion was persisting 1 week later. Follow up information was received on 03/06/2001 that clarified the sites of vaccination injections; right thigh for Prevnar and left thigh for Infanrix. Also, the patient had received 3 previous doses of Infanrix prior to this current one. The patient received no other vaccinations within four weeks of 01/12/2001, and was receiving no other medications concomitantly. The patient's symptoms lasted until the end of January 2001. U 01/12/2001 01/12/2001 0 UNK PUB PUB UNK Low-grade fever 99F (R) Pyrexia HQ6324224JAN2001 1
0168085 04/02/2001 IL U 03/01/2001 A pediatrician reported, via a company representative, than an unidentified child received Prevnar vaccine and subsequently, developed arthritis. No further information was available as of the date of this report. U UNK OTH OTH UNK UNK UNK HQ6542229JAN2001 1
0168086 04/02/2001 WI U 02/06/2001 A nurse reported that a pt received an injection of Prevnar and subsequently, developed cellulitis at the injection site. No further information was available at the date of this report. The reporter indicated that 13 pts experienced this event; however, they are not presently identifiable. Additional reports will be generated when identifying information is provided. U UNK OTH OTH UNK UNK UNK HQ6654831JAN2001 1
0168087 04/02/2001 OH 0.75 0 .7 F 02/09/2001 A mother reported that her 9 month old daughter received Prevnar and DTAP vaccines on 10/31/00. Approx. 1 week, post vax, she became "severely sick". She had a bright red rash from head to toe and was itchy. The rash went down her throat. She developed irritability, fevers above 103F, congestion, pink eye and was hard to wake up. As of 2/5/01, she had the rash again, and was congested. Additional information received from the physician on 03/13/2001 indicated that a diagnosis of right otitis media and sinusitis were made. The patient was treated with amoxicillin and recovered. Y 10/11/2000 11/01/2000 21 UNK PVT OTH NONE NONE UNK HQ6826605FEB2001 1
0168088 04/02/2001 MD 1.25 2 .3 F 03/16/2001 A nurse reported that a 15 month old female received her 1st injection of Prevnar and Fluzone vaccines on 12/4/00. Later that day, the child developed an injection site reaction characterized by bruising and pain upon touching. Two days later, the child experienced viral syndrome with diarrhea and a fever of 102.5F. This report is 1 of 3 cases of injection site reactions secondary to the same lot of Prevnar reported from the same institution. See case ID #'s HQ4692111DEC2000 and HQ6902606FEB2001 for the reports on the other cases. Follow-up information received on 3/5/01 revealed the child was not receiving concomitant medications. U 12/04/2000 12/06/2000 2 12/06/2000-Fever 102.5F PVT PVT UNK NONE UNK HQ6902506FEB2001 1
0168090 04/02/2001 AR 0.25 0 .3 M 02/15/2001 A nurse reported that a 3 month old male received Prevnar, Comvax, IPV and DTAP vaccines on 2/2/01. That day, he developed an injection site reaction on the left leg characterized by swelling, redness and tenderness. He experienced extreme fussiness, screaming and crying when any part of his left leg was touched. Prevnar and Comvax were both injected into the left leg. He was treated with ibuprofen. He recovered. Y Y 02/02/2001 02/02/2001 0 UNK PVT PVT NONE NONE UNK HQ6932107FEB2001 1
0168091 04/02/2001 TX 0.3 0 .3 M 02/21/2001 An NP reported that a 4 month old child received the 1st dose of Prevnar and 2nd doses of IPV, Tripedia and Act-Hib vaccines on 2/12/01. Later that day, the child developed a red rash on the face, buttocks and extremities. Additional information received from the nurse practitioner on 03/12/2001 indicated the infant was suffering from pharyngitis at the time of vaccination. U 02/12/2001 02/12/2001 0 UNK PVT OTH NONE NONE UNK HQ7246614FEB2001 1
0168092 04/02/2001 CA 0.8 M 02/28/2001 A mother reported that her 10 month old son with an ear infection received his 2nd dose of Prevnar on 2/1/01. That day, he developed a fever of 100F to 102F, diarrhea, nausea and vomiting. He was treated with azithromycin and cephalexin. As of 2/14/01, the fever resolved but the nausea, diarrhea and vomiting persisted. U 02/01/2001 UNK PVT OTH NONE Ear infection UNK HQ7300515FEB2001 1
0168093 04/02/2001 NY 0.5 0 .5 M 02/26/2001 A physician reported that a 6 month old infant received Prevnar and Tripedia vaccines on 1/24/01. Within minutes, post vax, the child developed flushing, especially facial flushing, and swelling at the site of the Prevnar injection. The child was treated with diphenhydramine and recovered. Additional information received from the patient's allergist on 03/12/2001 indicated the patient also developed facial swelling. Y 01/24/2001 01/24/2001 0 UNK PVT OTH NONE Eczema UNK HQ7386320FEB2001 1
0168094 04/02/2001 AK 0.08 F 02/23/2001 A nurse reported that a 44 day old female received injections of a 1st dose of Prevnar, a dose of DTAP, IPV and COMVAX on 2/12/01. On 2/13/01, 24 hours, post vax, the pt developed an erythematous rash on her face extending down onto her neck. She also developed a fever of 102F. Follow up information received from the original reporter on 04/02/2001 who indicated the patient's symptoms reportedly resolved. The rash actually occurred 3 days following vaccination on 02/15/2001 and was "probably" unrelated to vaccination. Y 02/12/2001 02/13/2001 1 2/13/01-102F fever PUB PUB UNK UNK UNK HQ7400820FEB2001 1
0168095 04/02/2001 IL 0.25 0 .2 M 03/21/2001 The mother of a 3 month old male reported that her son received his 2nd dose of Prevnar in 9/00 (approx. 3 months of age when received 2nd dose). The pt recently recovered from a "chronic dermatitis around his mouth" that resolved when he was switched to a latex-free bottle. In 11/00, the pt (approx. 5 months of age) developed a bilateral ear infection and sinusitis and was prescribed Zithromax (azithromycin). In 12/00, the symptoms were not resolving and the pt was prescribed Cefzil (cefprozil). NOTE: See report HQ8556919MAR2001 for events following the 3rd dose of Prevnar. N 09/01/2000 11/01/2000 61 UNK PVT PVT NONE NONE Dermatitis NOS HQ7407020FEB2001 1
0168096 04/02/2001 CA 2.75 1 .8 F 02/27/2001 A physician reported that a 33 month old female with a recent history of ear infection, received her 1st dose of Prevnar on 2/9/01. On 2/10/01, she developed a "mildly" itchy rash that started on her legs as small bumps and spread to her torso and then her face. The rash persisted throughout the week. U 02/09/2001 02/10/2001 1 UNK F/U no test performed PVT PVT NONE UNK Ear infection NOS HQ7541622FEB2001 1
0168097 04/02/2001 TX 0.3 0 .3 M 03/23/2001 A nurse reported that a 4 month old male received Prevnar, IPV, DTAP and haemophilus B vaccines on 2/20/01. Immediately, post vax, he developed a fever. The next morning, he developed a hard knot at an unspecified injection site and his movement was restricted. He was treated with alternating doses of ibuprofen and acetaminophen. On 2/22/01, his body temperature was 98.2F. U 02/20/2001 02/20/2001 0 UNK PVT OTH NONE UNK UNK HQ7664226FEB2001 1
0168098 04/02/2001 OH 1.25 1 .3 M 03/21/2001 This report was received on 2/21/01 from the mother of a 15 month old male who received his 1st dose of Prevnar, 3rd dose of Hib-Titer and Hep-B on 2/12/01. That same evening, the pt experienced a fever of 102F and difficulty using his legs. The pt recovered the following day. The pt was not receiving any concomitant medications and medical history was negative. Follow up information received on 04/11/2001 from the responsible physician indicating the patient did not receive Hib-Titer. Y 02/12/2001 02/12/2001 0 UNK PVT PVT UNK NONE UNK HQ7691026FEB2001 1
0168099 04/02/2001 TX 1.08 1 .1 F 03/23/2001 A mother reported that her 13 month old daughter received her 1st dose of Prevnar in mid 11/00. The child developed a rash that "looks like eczema" in mid 12/00. The rash started as dry patches on her face and has spread to her shoulders and neck. The rash is being treated with cortisone cream, which has "helped a little". The rash continues. U 11/15/2000 12/15/2000 30 UNK PVT PVT UNK UNK UNK HQ7796228FEB2001 1
0168100 04/02/2001 MD 0.2 0 .2 M 03/23/2001 A nurse reported that a 2 month old male received his 1st injection of Prevnar, Infanrix, PedvaxHib and IPV and a 2nd injection of Engerix-B on 2/16/01. The following day, the child developed congestion, a slight fever, vomited 1 time and was sleeping more frequently. The child was seen by a local pediatrician and noted to have clear lungs, soft abdomen, a soft stool with some mucous and blood. The child's mother was advised to stop drinking milk (child is breast fed). On 2/18/01, the child was noted to have a yellow stool, additional physical examination findings were normal. On 2/22/01, the child's pediatrician noted "mucoid stools, intermittent and blood noted. Child acts fine, 6 to 7 stools/day with blood, appear not as green." The child's mother received "Keflex 2 weeks ago for mastitis." This is 1 of 2 cases received from this reporter concerning adverse events following Prevnar lot 473331. Follow up information was received on 05/01/2001 from the patient's pediatrician. The patient continues to have diarrhea stools with mucous and further blood. Further evaluation is pending with a pediatric gastrointestinal physician. Follow up info has been received on 06/11/2001 from the 2 month old pt's pediatrician. The child has recovered. Y 02/16/2001 02/17/2001 1 2/17/01; physical exam-lungs clear, abdomen soft, stool soft and some mucous and blood; Culture stool-neg for Salmonella; Culture stool for parasites obtained. On 2/18/01; physical exam-WNL; WBC in stool-neg PVT PVT NONE UNK UNK HQ7810228FEB2001 1
0168101 04/02/2001 MD 2.0 2 .0 M 03/23/2001 A nurse reports post vaccine that same evening the pt could not walk. The following evening the pt developed injection site reaction characterized as a swollen, red hot left thigh and was seen by dr. The pt was noted to have diarrhea, fever and a generalized rash over entire body. That evening the child was up all night. F/U on 2/18/01 the child was seen by his pediatricianand noted to continue to have a 2-3" in diameter red and swollen injection site, a fever of 100.4F, red throat, and rash. The child was treated with amoxicillin. F/U info rec'd on 4/20/01 concerning the pt. The physician reported the child recovered from all events. The physician noted the child was a product of a 36 wk pregnancy and spontaneous vaginal delivery. The child has not drug allergies, chronic medical problems, but has had the occasional cold. Y U 02/16/2001 02/17/2001 1 UNK PVT PVT none UNK UNK HQ7824828FEB2001 1
0168102 04/02/2001 IL 0.6 0 .6 M 03/20/2001 The mother of a 7 month old male reported that her son received his 3rd Prevnar in 1/01. The pt recently recovered from a "chronic dermatitis around his mouth" that resolved when he was switched to a latex-free bottle. He received his 1st and 2nd doses of Prevnar in 8/00 and 9/00, respectively. In 11/00, the pt (approx. 5 month of age) developed a bilateral ear infection and sinusitis and was prescribed Zithromax (azithromycin); see HQ7407020FEB2001 for this report. In 12/00, the symptoms were not resolving and the pt was prescribed Cefzil (cefprozil). In 1/01, the pt developed bronchiolitis and "a more sever" bilateral ear infection. He was prescribed steroids and Cefzil again. U 01/01/2001 01/01/2001 0 UNK PVT PVT UNK NONE Dermatitis NOS HQ8556919MAR2001 1
0168103 04/02/2001 IN U 02/06/2001 A pharmacist reported that an unidentified pt received an injection of Prevnar and subsequently, developed swelling at the injection site that extended over the entire leg. The reporter indicated that 3 pts experienced this event with Prevnar lot 471212. Additional reports will be generated when identifying information is provided. U 11/01/2000 UNK PVT OTH UNK UNK UNK HQ4430704DEC2000 1
0168104 04/02/2001 UT 1.25 1 .2 M 02/07/2001 A 15 month old male received his 1st dose of Prevnar, as well as, his 4th doses of Tripedia and ActHIB on 9/12/00 and within 1 t0 7 days, post vax, he developed fever and an injection site reaction characterized by redness and swelling at the Prevnar injection site. U 09/12/2000 UNK PVT PVT NONE NONE UNK HQ4658208DEC2000 1
0168105 04/02/2001 MT 1.2 M 01/25/2001 A 14 month old male received his 1st dose of Prevnar in 11/00 and the next day, developed an injection site reaction characterized by a 1 1/2cm area of erythema, swelling and tenderness. As of 12/7/00, no further information was available. U 11/01/2000 11/02/2000 1 UNK PVT PVT NONE NONE UNK HQ4659508DEC2000 1
0168106 04/02/2001 WI 3.0 3 M 01/29/2001 A territory representative reported that a 3 year old male received an injection of Prevnar on 12/5/00. The next day, the child developed an injection site reaction characterized by swelling and a 6cm X 4cm area of redness and warmth. He recovered. This is 1 of 3 pts from this facility who had an adverse experience following receipt of Prevnar lot 471231. Y 12/05/2000 12/06/2000 1 UNK OTH OTH Insulin Human NONE Diabetes Mellitus NOS HQ4776112DEC2000 1
0168107 04/02/2001 NC 0.5 0 .5 F 01/11/2001 A pharmacy technician reported that her co-worker's 6 month old daughter received her 1st dose of Prevnar and other unspecified vaccines on 12/12/00. Three to four hours, post vax, the pt developed fever of 105F and she was seen in the ER. The pt was treated with ibuprofen and acetaminophen; she was catheterized. Viral infection was ruled out by blood test. The pt slept "a lot" and her fever increased 102F. She was again treated with ibuprofen. She was not admitted to the hospital. On 12/13/00, she developed fever white at daycare and her mother has been administering ibuprofen and acetaminophen. The reporter indicated that the pt's mother stated that her daughter's legs looked swollen at the injection sites. Exact administration site of Prevnar was not specified. Y U 12/12/2000 12/12/2000 0 UNK PVT OTH NONE NONE UNK HQ4994218DEC2000 1
0168108 04/02/2001 TN 0.6 0 .6 F 01/10/2001 A mother who is also a nurse, reported that her 7 month old daughter received her 1st dose of Prevnar, as well as, her 3rd dose of DTAP and Recombivax vaccines on 12/13/00 and the next day, developed induration on both sides of her right leg below the level of the Prevnar injection site. The mother stated that she feels "that the nurses technique was faulty" and the route of administration was either subcutaneous or intradermal. U 12/13/2000 12/14/2000 1 UNK PVT PVT NONE NONE UNK HQ5008218DEC2000 1
0168109 04/02/2001 CO 0.8 0 .9 M 12/27/2000 An MA reported that a 10 month old male received an injection of Prevnar on 12/4/00. The next day, the infant developed a fever of 102.5F and a large area of induration at the injection site. On 12/6/00, he was seen in an ER and treated with Cefzil (cefprozil), Motrin (ibuprofen) and Tylenol (acetaminophen). The next day, the infant was seen by the physician. On 12/8/00, he was again seen by the physician. At that time, the injection site induration was improving but his fever was reportedly 104.5F. He was referred to an ER where a CBC was performed. His white blood cell count was 4.5, differential was 21%, band neutrophils were 16% and lymphocytes were 43%. A blood culture and a chest x-ray were negative. An unspecified urine test was negative. The ER physician felt that the child had an "acute viral syndrome"; however, the pediatrician felt the symptoms were a "vaccine reaction". On 12/9/00, the infant was seen by the physician. The next day, he developed "whole-body rash". On 12/11/00, he was seen again by the physician who changed the infant's treatment to Zithromax (azithromycin) and Atarax (hydroxyzine). He recovered. Y Y 12/04/2000 12/05/2000 1 Blood Culture-neg; CBC-white blood cells-4.5; differential-21%; Band neutrophils-16%; Lymphocytes-43%; X-ray NOS-neg. PVT PVT NONE NONE UNK HQ5020519DEC2000 1
0168110 04/02/2001 AL 1.0 1 .0 F 01/11/2001 A physician reported that a 12 month old female received her 1st dose of Prevnar, as well as, varicella, measles, mumps and rubella and hepatitis B vaccines on 9/29/00 and within 1 to 5 days, post vax, developed fever of 103F and a rash. The physician indicated that the pt developed a rash from the MMR vaccine. U 09/29/2000 10/01/2000 2 UNK PVT OTH UNK NONE UNK HQ5076519DEC2000 1
0168111 04/02/2001 FL 3.0 F 01/15/2001 A territory representative reported that pt rec'd vaccine and immediately developed a rash on back, chest and face. She was treated with diphenydramine. She recovered. The reporter indicated that the child was being treated with an unknown antibiotic and decongestant for an unspecified illness at the time of immunization. Y Y PVT OTH UNK UNK UKN HQ5596205JAN2001 1
0168112 04/02/2001 CA 0.2 U 01/15/2001 Irritability post vac. A physician reports post vaccine pt became fussy. The infant recovered after 24 to 30 hours. Y Y PVT OTH UNK UK UNK HQ5648008JAN2001 1
0168113 04/02/2001 TX 1.8 2 .7 M 02/09/2001 A nurse reports post vaccine, within 12 hrs pt developed fever of 104F measured rectally. Y 10/31/2000 UNK PVT OTH NONE NONE UNK HQ5714509JAN2001 1
0168114 04/02/2001 IL 0.9 0 1 F 01/22/2001 Mother reports post vaccine that evening pt developed hives on her legs, the hives spread over her entire body. She was treated with acetaminophen. She recovered. Y 12/14/2000 12/14/2000 0 PVT PUB NONE NONE UNK HQ5714709JAN2001 1
0168116 04/02/2001 TX 3.0 3 M 02/28/2001 A nurse reports post vaccine in the evening pt developed significant swelling at the injection site. The swelling was approximately 5cm to 7cm across. The reporter indicates the child recovered. Y 01/04/2001 01/05/2001 1 PVT OTH NONE NONE UNK HQ5990416JAN2001 1
0168117 04/02/2001 OH U 02/28/2001 A nurse reported post vaccine within 24 hrs pt became irritable. The pt recovered Y UNK PVT OTH UNK NONE UNK HQ6021117JAN2001 1
0168118 04/02/2001 NJ 1.58 1 .6 M 02/09/2001 A physician reports post vaccine, that evening pt developed fever of 102F, 24 hours post vaccine he developed generalized hives. U 01/17/2001 01/17/2001 0 PVT PVT NONE NONE UNK HQ6224922JAN2001 1
0168119 04/02/2001 NY 1.0 1 .1 M 03/01/2001 A mother reports post vaccine within 24 hours the pt developed fever of 103F, vomiting, diarrhea, difficulty sleeping and irritability. Mother states that the child's physician does not believe symptoms are related to vaccine. Mother states her sister's child had a similar though much worse reaction. Additional information received from the physician on 03/20/2001 stated that the office was not aware of the child's adverse experience post-immunization. U 01/18/2001 01/18/2001 0 UNK PVT PVT NONE NONE UNK HQ6394625JAN2001 1
0168120 04/02/2001 AK U 03/05/2001 A physician reports post vaccine pt subsequently developed more immediate type injection site reactions and crying episodes. Y U OTH OTH HQ6466726Jan2001 1
0168121 04/02/2001 PA 0.6 0 .2 M 02/15/2001 A nurse reported that her 7 month old son post vaccine's developed an injection site reaction described as hot, raised and red. U 08/30/2000 PVT PVT HQ6520229Jan2001 1
0168122 04/02/2001 AK U 03/01/2001 A physician reported via a Co representative, that post vaccine pt experienced pain upon administration. Follow up information received from the physician on 03/08/2001 stated that the physician does not know the specific identity of these patients. The nurses administering Prevnar reported the adverse events described to the physician, plus increased immediate crying post-immunization. Y Y OTH OTH HQ6540329JAN2001 1
0168123 04/02/2001 TX 1.7 M 02/16/2001 A mother reports post vaccine pt developed an injection site reaction characterized by redness, swelling, and warmth at the injection site. He recovered. Y PVT UNK HQ6705301FEB2001 1
0168124 04/02/2001 MD 1.25 1 .3 F 03/21/2001 A nurse reports post vaccine, later that evening the pt developed an injection site reaction characterized by swelling, redness, and pain which progressed to include her left leg. Follow up information rec'd from pt's physician indicated 2 wks prior to vaccine's the child experienced gastrointestinal symptoms. At the time of vaccine the pt has a 1-2 day history of cough with sneezing. Y 11/28/2000 11/28/2000 0 PVT PVT 1-2 days of cough with sneezing past conditions; gastrointestinal disorder NOS ~Measles + Mumps + Rubella (MMR II)~~0.00~In Sibling HQ6902606FEB2001 1
0168125 04/02/2001 UT 0.7 0 .7 F 02/12/2001 Injection site reaction. It was reported 2 days post vaccine the pt developed a big, red hard lump at the injection site. Follow up states the event has resolved. Y 01/09/2001 01/22/2001 13 PVT OTH NONE UNK UNK HQ6931507FEB2001 1
0168126 04/02/2001 CA 2.0 2 .4 M 02/09/2001 A mother reports post vaccine pt developed high fever, diarrhea and vomiting for 5 days. The reporter noted that her HCP told her this was not related to Prevnar. An antibody titer was drawn, however results were pending. The child has a history of ear and upper respiratory tract infections since he was 5 months old. Allergies have been ruled out by a blood test. Common variable immune deficiency syndrome was ruled out. IGA antibody tests were negative. Y Y 12/22/2000 IGA test were negative, all other test were negative. PVT OTH NONE NONE Past Conditions; diarrhea Nos, Drug specific antibody absent; flatulence, increased activity; influenza. developed influenza, diarrhea, and abdominal gas~Pneumo (Prevnar)~~0.00~In Patient HQ7032409FEB2001 1
0168127 04/02/2001 PA F 02/15/2001 A pediatrician reported post vaccine's pt developed a fever of 103F and swelling at the Prevnar injection site, extending from the thigh down to the knee. U 02/06/2001 02/06/2001 0 OTH OTH Gantrisin UNK UNK HQ7168413FEB2001 1
0168128 04/02/2001 PA 0.3 M 02/20/2001 It was reported pt post vaccine's developed fever of 105F along with an injection site reaction described as hard, inflamed and swollen. The child also experienced irritability. U 10/11/2000 10/11/2000 0 PVT PVT UNK NONE UNK injection site reaction following his first injection of Prevnar, HIB, DTap, and HepB,the reaction was described as hot raised a HQ7250114FEB2001 1
0168129 04/02/2001 AL 1.55 1 .6 F 02/26/2001 It was reported post vaccine pt developed a rash that extended from her head to her toes. Pt also vomited and became irritable. Additional information received from the physician on 03/14/2001 indicated the patient recovered. Y 02/13/2001 02/13/2001 0 UNK PVT PUB NONE NONE Past conditions: ear infections NOS HQ7300115FEB2001 1
0168130 04/02/2001 CA M 03/13/2001 Mother of pt reports post vaccine pt experienced injection site redness. U PVT OTH UNK NONE Concurrent conditions; hypersensitivity NOS HQ7346316FEB2001 1
0168131 04/02/2001 TX 1.5 M 02/27/2001 It was reported post vaccine pt developed an injection site reaction characterized by redness, swelling, and heat at an unspecified site. U 02/15/2001 02/16/2001 1 PVT PVT UNK UNK UNK HQ7452221FEB2001 1
0168132 04/02/2001 LA 0.8 0 .9 U 02/27/2001 It was reported that 3 hrs post vaccine the pt developed a fever 102.2F, the pt was taken to the emergency room. Y U 02/22/2001 02/22/2001 0 OTH OTH UNK UNK UNK HQ7642126FEB2001 1
0168133 04/02/2001 PA U 02/27/2001 It was reported post vaccine pt developed injection site reaction characterized by 5cm hard red lump. Y PVT OTH UNK UNK UNK HQ7665126FEB2001 1
0168134 04/02/2001 IN 3.0 F 03/23/2001 It was reported post vaccine the pt developed a fever of 104.5F. She also developed an injection site reaction characterized by a 6.5" by 3.5" in area of redness and swelling. As of the date of this report the child is not much better. Follow up information received from the physician on 04/17/2001 indicated that the patient received the injection of Prevnar on 02/19/2001 and recovered. Y 02/19/2001 UNK OTH OTH UNK UNK UNK HQ7718727FEB2001 1
0168135 04/02/2001 TX 0.3 U 02/27/2001 It was reported 2 hrs post vaccine pt developed an injection site reaction characterized by redness, swelling and heat at an unspecified site. U 02/15/2001 02/15/2001 0 PVT PVT UNK UNK UNK HQ7723927FEB2001 1
0168136 04/02/2001 CA 3.0 0 .7 F 03/23/2001 A mother reports post vaccine pt developed wheezing, diarrhea, vomiting, rash and was irritable. The mother considered these events to be an allergic reaction. The patient recovered by 01/08/2001. Follow up information received from the physician on 04/22/2001 indicated the patient received Prevnar, Act-Hib, and Tripedia vaccines. The following day the patient developed nasal congestion, an "occasional" cough, runny nose, vomiting X 2 and mild diarrhea. The patient was diagnosed with a viral syndrome which resolved the following day without treatment. The patient also developed an injection site reaction characterized by redness and swelling. Y 01/05/2001 01/06/2001 1 PVT PVT UNK NONE UNK HQ7744127FEB2001 1
0168137 04/02/2001 CA M 03/13/2001 It was reported by mother of pt, post vaccine the pt experienced injection site redness. U PVT OTH UNK NONE Concurrent Conditions: Hypersensitivity NOS HQ8290412MAR2001 1
0168211 04/02/2001 GA U 02/16/2000 One week post vax, the pt experienced swelling and a rash at the injection site. The child was seen by a physician and treated at the office. The most recent information received on 2/11/00 reports the condition of the pt as unknown. Y U OTH OTH 20000041461 1
0168212 04/02/2001 GA F 04/19/2000 One week post vax, the child had definite lethargy and high fever. Additionally, the child had heat and a 2cm induration at the injection site. The pt was seen by a physician and treated at the office. The most recent information received on 4/12/00 reported the condition as completely resolved. Y Y 02/02/2000 PVT OTH 20000042431 1
0168213 04/02/2001 GA 0.2 0 .2 M 03/24/2000 One day post vax, on 2/14/00 the pt experienced significant local swelling (twice as big), hot to the touch, redness, pain and tenderness at the injection site as well as fussiness and fever. The swelling was localized on the left thigh and persisted 1-2 days. Benadryl and Tylenol were administered and they relieved swelling after a "couple" of doses. He was treated by his mother with cold compresses with a resolution of symptoms in 24 hours. The most recent information received on 3/14/00 reports the outcome of the pt as resolved. Y 02/14/2000 02/15/2000 1 OTH OTH 20000053021 1
0168214 04/02/2001 GA 0.5 0 .2 F 03/15/2000 The pt experienced significant local swelling (twice as big), hot to the touch, redness, pain and tenderness at the injection site. Additionally there was a hard area around the injection site. The pt returned to the office on 2/16/00 and was treated with Keflex for possible cellulitis. The pt recovered on 2/17/00. The most recent information received on 2/18/00 reports the outcome of the pt as resolved. Y Y 02/15/2000 02/15/2000 0 OTH OTH 20000053211 1
0168216 04/02/2001 GA 1.5 1 .5 M 03/15/2000 On 2/8/00, the pt experienced significant local swelling (twice as big), hot to the touch, redness, pain, hardness and tenderness at the injection site. He could not walk. Outpatient treatment was required. Physician prescribed Benadryl and a warm towel compress to treat injection site swelling. The most recent information received on 3/14/00 reports the condition of the pt as resolved. Y Y 02/08/2000 02/08/2000 0 OTH OTH 20000053341 1
0168217 04/02/2001 VT M 04/24/2000 The evening of the vax, the pt experienced a fever of 101 (rectal) which was treated with Tylenol and lasted three days. The most recent information received on 3/27/00 reports the condition of the pt is resolved. Y 01/24/2000 01/24/2000 0 PVT OTH 20000114801 1
0168218 04/02/2001 VT 0.2 M 04/24/2000 Following vax, the pt experienced sleepiness and a red injection site. The pt was treated with Tylenol. The most recent information received on 3/27/00 reports the condition of the pt as resolved. Y 12/14/1999 PVT OTH 20000114851 1
0168219 04/02/2001 VT 0.2 F 04/25/2000 On 2/15/00 the pt received her second dose of Infanrix. Subsequently she was sleepy for 24 hours, screamed for 4 hours and was flaccid, had a fever the next day and had a slightly red injection site. The pt was treated with Tylenol. Outcome resolved. The most recent information received on 3/27/00 reports the condition of the pt as resolved. Following the 1st dose, the pt was lethargic, but recovered. Y 02/15/2000 PVT OTH lethargic~DTaP (Infanrix)~1~0.00~In Patient 20000115661 1
0168220 04/02/2001 VT 0.2 M 04/25/2000 On 12/21/99, the pt received his first dose of Infanrix, subsequently he screamed and was difficult to console. Additionally he had a fever of 100.6 degrees (rectal). Outcome of pt is resolved. Y 12/21/1999 PVT OTH 20000115861 1
0168221 04/02/2001 VT 0.2 M 04/25/2000 On 12/23/99, the pt received his first dose of Infanrix. Subsequently on 12/23/99 he screamed for two hours. Outcome: resolved. The most recent information received on 3/27/00 reports the condition of the pt as resolved. Y 12/23/1999 12/23/1999 0 PVT OTH 20000115961 1
0168222 04/02/2001 VT 1.25 F 04/25/2000 In 2/00 the pt received her third dose of Infanrix. Subsequently, the same day as the vax, she screamed and had a fever and soreness at the injection site (leg). No treatment was given. Outcome: resolved. The most recent information received on 3/27/00 reports the condition of the pt as resolved. Y 02/01/2000 PVT OTH 20000116031 1
0168223 04/02/2001 VT 1.25 M 04/25/2000 On the same day of vax, the pt experienced redness and heat at the injection site, which was 1/2/ the size of a softball. Outcome: resolved. The most recent information received on 3/27/00 reports the condition of the pt as resolved. Y PVT OTH 20000116211 1
0168224 04/02/2001 VT 0.2 F 04/25/2000 Following vaccination, the same day the pt cried for 6 hours. No treatment was given. The outcome is resolved. The most recent information received on 3/27/00 reports the condition of the pt as resolved. Y 02/01/2000 02/01/2000 0 PVT OTH 20000116221 1
0168225 04/02/2001 VT 0.2 F 04/25/2000 Two hours post vax, the pt was irritable, and screamed for nine hours. The injection site was swollen. The next day she was "out of sorts". The most recent information received on 3/27/00 reported the condition of the pt as resolved. Y 01/21/2000 01/22/2000 1 PVT OTH 20000116231 1
0168226 04/02/2001 GA 1.5 M 04/26/2000 One day post vax, it was reported that the pt developed left hip to knee swelling, erythema, heat (injection site), and tenderness to the touch (injection site). MD visits on 3/24/00 and 3/25/00 were required, and the pt was found to have cellulitis. No crepitus was noted, no drainage, no fever, and no cultures were obtained. He was treated with Rocephin on 3/24/00. Decadron on 3/25/00 and then Cephalexin for 10 days. The most recent information received on 4/4/00 reports that the pt is lost to follow-up. Y U 03/23/2000 03/24/2000 1 CBC - unk OTH OTH 20000116341 1
0168229 04/02/2001 TN 1.6 M 05/04/2000 One day post vax, the pt's father called and reported swelling around the site of the Infanrix injection. He was advised to treat the reaction with ibuprofen and diphenhydramine, and to contact the physician if the reaction worsened or persisted. Two days later (3 days post vax), the father reported that the swelling was almost completely resolved and that the child was generally well and normally active. No sequelae have been reported. The most recent information received on 8/18/00 reports the condition of the pt is resolved. Y OTH OTH hx of otitis media 20000123631 1
0168230 04/02/2001 TN 1.25 M 06/28/2000 Within 12 hours of the fourth dose of Infanrix, the pt experienced swelling of the injection site from the hip to the knee, noted by his mother. The swelling was 2cm greater than the other thigh. There was warmth, erythema and tenderness at the injection site. The physician prescribed diphenhydramine (Benadryl), loratadine (Claritin), ibuprofen and cold compresses. The most recent information received on 4/18/00 reported the symptoms resolved within 48-72 hours. Y Y OTH OTH 20000194481 1
0168232 04/02/2001 WA 4.0 4 F 06/29/2000 Following vaccination, the pt experienced a hot, red, sore spot at the injection site. Acetaminophen (Tylenol) was given as treatment. The most recent information received on 4/27/00 reported the symptoms resolved on the second day. Y 04/19/2000 04/19/2000 0 PUB PUB 20000196661 1
0168233 04/02/2001 WA 5.0 F 06/29/2000 36-48 hours post vax, the pt went to the doctor and presented with swelling of her left arm. It was markedly swollen from her elbow to her shoulder approximately twice the size of the right arm. The pt also had localized erythema and induration at the injection site. Treatment included topical hydrocortisone cream, diphenhydramine, and Amoxicillin. The most recent information received on 5/15/00 reported the symptoms resolved within 5 days. When she went to her doctor, she did not appear to be clinically ill and was afebrile. She was later hospitalized for viral-syndrome which reported as a non-event. Y Y 04/06/2000 04/08/2000 2 PUB PUB 20000198111 1
0168234 04/02/2001 GA 1.5 M 07/13/2000 On 5/2/00, the pt received the fourth dose of Infanrix and approximately 24 hours later he experienced rapid swelling of the left thigh from hip to knee approximately one inch greater than the right thigh. His mother noticed redness "like an insect bite", erythema, induration and warmth at the injection site. 48 hours post vax, the pt experienced a fever of 103 degrees and was taken to the ER. He was treated with oral antipyretics. The ER physician noted the child's fever had improved, he did not appear to be clinically ill and his thigh was only slightly swollen. The most recent information received on 5/5/00 reported the symptoms were resolving. Y Y 05/02/2000 05/03/2000 1 PVT PVT allergic conjunctivitis, ear infection, folliculitis, pustular eosinophilia 20000209731 1
0168235 04/02/2001 TX 4.0 4 F 08/02/2000 On 2/24/00 at 2:00 the pt developed a fever of 105. The most recent information received on 7/7/00 reports the outcome of the event as recovered. Y 02/21/2000 02/24/2000 3 OTH OTH NONE 20000231731 1
0168236 04/02/2001 OK 5.0 5 F 09/29/2000 On 8/9/00 the pt was seen in the doctor's office with no immunization record. The pt was given Infanrix and IPV. It was later discovered that these vaccinations had already been given to the child. The physician reported that the pt experienced a localized reaction with redness, swelling, itching, and bruising. The physician considered these reactions to be moderate in intensity and related to Infanrix. As of 9/29/00, the outcome of the events is resolved. Y 08/09/2000 08/10/2000 1 PVT PVT 20000276581 1
0168237 04/02/2001 MN 1.25 M 09/19/2000 Within hours of the vax, the pt experienced generalized body hives. An ER or doctor visit was required and the pt was treated with diphenhydramine hydrochloride (Benadryl) on 8/15/00. As of 8/15/00, the outcome of the event is unresolved. N 08/14/2000 08/14/2000 0 PVT OTH 20000276891 1
0168238 04/02/2001 TX 4.0 4 M 11/13/2000 8 days post vax, the pt developed cellulitis at the injection site. A doctors visit was required. Starting on 8/2/00 the pt was treated with ceftriaxone sodium (Rocephin). The cellulitis resolved on 8/12/00. The physician believed it was related to the injection and not to the vaccine. The adverse event was considered to be mild in intensity. As of 11/10/00, the outcome of the event is resolved. Y 07/24/2000 08/01/2000 8 PVT PVT allergy to PCN 20000307201 1
0168239 04/02/2001 VA 4.0 F 10/26/2000 In 1999, the pt received her 2nd dose of DTPa vaccine. "A few days later", she experienced hives. As of 10/23/00, the outcome of the event is resolved. Y OTH OTH NONE NONE NONE 20000312991 1
0168240 04/02/2001 AR 1.25 M 11/08/2000 On 11/1/00, the vaccinee received his 1st left lateral thigh dose of Infanrix. "Immediately" upon vaccination, the vaccinee experienced swelling and redness at the injection site. A doctor visit was required on 11/3/00 and the vaccinee was treated on 11/3/00 with acetaminophen (Tylenol) prn. As of 11/7/00, the outcome of the event is resolved. Y Y 11/01/2000 11/01/2000 0 PVT PUB Augmentin, Histex (carbinoxamine maleate) NONE NONE 20000324011 1
0168241 04/02/2001 WV 0.5 F 11/08/2000 The vaccinee received her 3rd dose of haemophilus influenza B vaccine on 10/30/00. On 6/27/00, 8/28/00 and 10/30/00, the vaccinee received her 1st, 2nd and 3rd left thigh doses of Infanrix. Three days, post vax, of the 3rd Infanrix, on 11/2/00, the pt was seen in physician's office with redness and swelling below the injection site. There was no fever noted, nor complaint of pain or fussiness. No treatment was given. As of 11/2/00, the outcome of the events is unknown. Y U 10/30/2000 11/02/2000 3 PVT PVT 20000324071 1
0168242 04/02/2001 WV 4.0 M 11/08/2000 On 9/29/00, the pt received his 5th, left arm, dose of Infanrix. The pt's mother stated that 2 days later, on 10/01/00, the vaccinee developed a red, hot, purple rash below the injection site. The vaccinee did not complain of pain; the site was swollen. On 10/6/00, the pt experienced multiple hives in various sizes on the left arm only below the injection site which blanched with pressure. No itching or fever was noted. A doctor visit was required and the pt was treated with diphenhydramine hydrochloride 12.5mg every 6 hours. As of 11/2/00, the outcome of the event is unknown. Y U 09/29/2000 10/06/2000 7 PVT PVT 20000324191 1
0168243 04/02/2001 WV 1.5 F 11/08/2000 The vaccinee "is a normal, healthy, 18 month old with no known allergies", who received concomitant HIB and IPV on 8/21/00. On 8/21/00, the pt also received her 4th left leg dose of Infanrix. On 8/23/00, the pt returned to the doctor's office presenting with a 6" area below the injection site that was red with a purple tinge and warm. The pt did not have a fever or pain. She was very fussy. She was treated from 8/23/00 to 8/28/00 with hydroxyzine hydrochloride (Atarax) 0.5mg po prn every 8 hours. As of 11/2/00, the outcome of the event is unknown. Y U 08/21/2000 08/23/2000 2 PVT PVT 20000324331 1
0168244 04/02/2001 LA 0.2 M 11/09/2000 The vaccinee is healthy and had no known allergies. He received his 1st injections of IPV and HIB on the date of the Infanrix vaccination. There is no family history of vaccine-related events. In late July or early August, 2000, the pt received his 1st dose of Infanrix. Between 30 and 60 minutes, post vax, the pt's mother was contacted by the pt's daycare provider, who reported that he was irritable, crying, and had a temperature of 104F. (The anatomic site of temperature measurement was not known). The pt was treated with ibuprofen and acetaminophen orally and recovered without sequela. As of 11/7/00, the outcome of the events is resolved. Y OTH OTH NONE NONE NONE 20000325971 1
0168245 04/02/2001 IL 4.0 F 01/19/2001 The pt had no concurrent medical conditions; specifically, she had no known allergies. She was taking no concurrent medications. She received an injection of Infanrix on 12/1/00. Within 24 hours, she developed a large, raised area of firmness, redness, swelling and warmth at the injection site. She was seen by the physician, who noted that the injected thigh was 5cm larger in circumference that the contralateral thigh. The injection site swelling did not extend to the hip or knee. The pt was treated with loratadine (Claritin) and warm compresses to the injection site. She recovered by 12/4/00. The reporter indicated that 2 pts experienced injection site reactions following receipt of Infanrix lot DTPA972A2. However, only 1 pt was identified. Y Y 12/01/2000 12/02/2000 1 PVT OTH NONE NONE NONE 20000353071 1
0168248 04/02/2001 CA 0.2 0 .2 M 02/01/2001 The same day of vax, the pt developed moderate redness and swelling at the Infanrix site. Half of his thigh became inflamed. He recovered without treatment. The reporter considered the thigh inflammation, injection site redness, and injection site swelling to be related to Infanrix administration. Y 12/11/2000 12/11/2000 0 PVT PVT NONE 20000358981 1
0168249 04/02/2001 CA 2.0 1 1 M 02/01/2001 On 12/1/00 within hours of vax, he developed severe redness and swelling at the injection site. He also developed a moderate fever and moderate pain. On 12/2/00 he developed moderate swelling of his thigh. He recovered on 12/2/00 without treatment. The reporter considered the fever, pain and swollen thigh to be related to the Infanrix administration. Y 12/01/2000 12/02/2000 1 PVT PVT NONE 20000358991 1
0168250 04/02/2001 CA 1.5 1 .5 F 02/01/2001 Within 24 hours of vax on 12/8/00, the pt became fussy. Two days post vax on 12/9/00 she developed moderate redness and swelling at the Infanrix site. She was treated with ibuprofen (Motrin) and recovered. The reporter considered the fussiness, injection site redness, and injection site swelling to be related to Infanrix administration. Y 12/07/2000 12/08/2000 1 PVT PVT 20000359001 1
0168251 04/02/2001 CA 4.0 4 M 02/01/2001 Within 24 hours of vax, on 12/8/00 he developed severe redness and swelling at the Infanrix injection site. He also developed severe swelling of his right thigh, the swelling was almost circumferential. His thigh was not tender. He was treated with diphenhydramine (Benadryl) and ibuprofen (Motrin). He recovered 12/12/00. The reporter considered the thigh swelling to be related to the vax administration. Y 12/07/2000 12/08/2000 1 PVT PVT NONE 20000359021 1
0168252 04/02/2001 OH 0.5 0 .5 F 01/03/2001 The infants mother reported that at a later unspecified date, the infant developed diarrhea. The infant recovered after nine days. The vaccine provider stated "we have no record of a problem". The infants mother reported that the infant subsequently developed a fever and a rash following her second dose of Rota Shield. Y 05/04/1999 PVT PVT 20000368851 1
0168254 04/02/2001 FL U 03/28/2001 On an unspecified date, a child received an injection of DTPa. Some time later (date not provided), the child developed an abscess at an unspecified site. The child was treated with an antibiotic. Outcome of the event was not provided. The reporter indicated that two additional children experienced this event following receipt of DTPa, they did not require antibiotic therapy. These two pt's are not presently identifiable. Additional reports will be generated when identifying information is provided. U PVT OTH 20010021551 1
0168340 04/02/2001 MN U Seizure; patient visit. Y U 03/07/2001 UNK UNK 1
0168153 04/03/2001 NC 0.25 0 .2 M 03/21/2001 The infant had an instant scream with administration of Prevnar (IPV 1st, Prevnar 2nd, Hib 3rd). The infant became pale, diaphoretic, hypotonic, hyporesponsive, turned bluish across the eyebrows with circumora.. His eyes deviated sharply to the upper right side held there about 30 secs. When his eyes returned to normal position he responded to painful stimuli to ear lobes then to mandibular joints. Cry resulted in color of skin normalization after 15:20. The patient was left clonic. The DTaP was administered to the infant he turned slightly pale, but quickly recovered with mother consoling. The infant firmly began to suck his bottle. The doctor Administered 0.4 ml of APAP med for fever precaution. The mother instructed in what to watch for in the infant behavior for immunization reaction and seeking emergency help. The mother expressed understanding via spanish interpretation. When the infant left the clinic he had good color and was sleeping in the infant seat about 4:50 pm. No oxygen was ever needed, as the infant was treated the doctor responded very quickly. The infant maintained respiratory and heart rate; CPR not needed. Y Y 03/19/2001 03/19/2001 0 NONE PUB PUB NONE NONE 35 week gestation (prematurity) NC01040 1
0168154 04/03/2001 CT 44.0 44 M 03/25/2001 The pt experienced Lyme disease symptoms. Chronic arthritis, significant joint and muscle pain. Lightheadedness, blurred vision, memory loss, slurred speech and sleep disorder. The pt has constant stiffness. Y U 06/28/1999 09/02/1999 66 HLA-DR4 - pos PVT OTH Doxycycline, Ceftin, Biaxin, IV Rocephin, Celebrex NONE NONE 1
0168155 04/03/2001 CA 0.3 0 .3 F 03/22/2001 Mother reports seizures that started one day post vaccine, gradually lessened in frequency, last seizure 2/25/01. EEG normal. Y U 01/17/2001 01/18/2001 1 EEG pending, CT scan negative PVT PVT NONE Nevi; jaundice early newborn seizures~DTP + Hib (no brand name)~1~0.30~In Patient|~Hep A (no brand name)~1~0.00~In Sibling CA010024 1
0168156 04/03/2001 CA 1.46 1 .5 F 03/28/2001 It was reported post vaccine pt had temp of 103-104F and hives, 10 days later increased rash, legs clustered red papular 1mm-3mm size. Also with otitis. Y 03/07/2001 03/07/2001 0 Seen by inf disease Dr. PVT PVT Bronchiolitis NONE 1
0168157 04/03/2001 NY 2.0 2 .0 F 03/20/2001 It was reported 5 days post Prevnar pt developed erythema multiforme on face, legs and arms. Y 02/13/2001 02/22/2001 9 PVT PVT NONE NONE 1
0168158 04/03/2001 NY 0.3 0 .3 F 03/20/2001 Mother reports pt fell asleep at noon after receiving vaccine and slept all day, Mom had to wake to feed not easily aroused and only took 4oz of formula, had voided. early OM - TM red. Y 03/01/2001 03/01/2001 0 CBC w/diff-WNL PVT PVT NONE NONE 1
0168159 04/03/2001 TN 1.5 1 .5 M 11/30/2000 It was reported post vaccine pt had erythema of right anterior thigh with 5x8cm (medial aspect) no sign of infection. Y 11/28/2000 11/29/2000 1 PVT PVT Omnicef, daily vitamin NONE NONE TN01012 1
0168160 04/03/2001 WA 3 M 03/24/2001 Pt unable to bear weight later same evening. Y 03/22/2001 03/22/2001 0 PVT PUB Intal inhaler 1
0168161 04/03/2001 VA 1.08 1 .1 F 03/28/2001 Vesicular lesions - appearing on face trunk, extremities. Y 03/15/2001 03/24/2001 9 PUB PUB NONE Otitis Media NONE 1
0168162 04/03/2001 WI 0.3 0 .3 F 03/22/2001 Within 24 hrs onset of fever 101.5F, irritable, erythematous rash - seen by MD on 3/19/01. Fever subsided - rash faint per MD report. Y Y 03/16/2001 03/16/2001 0 NONE PVT PVT none none well baby check none 1
0168163 04/03/2001 MI 4.0 4 F 03/15/2001 Pt sent home from school vomiting, temp 102F, sleeping a lot. Mom took him to ER temp 104F, vomiting, hives at waistline,armpits,and on face. ER report says temp 101.7F and dx gastroenteritis, 1 day post vaccine injection site puffy, complained of abdominal cramps. Y Y 03/13/2001 03/13/2001 0 PUB PUB Asthma when young (until 18 mo), allergy - Amoxicillin 1
0168164 04/03/2001 MN 1.25 1 .3 M 03/26/2001 Fever and extreme fussiness 1 hr post immunizations Y Y 03/15/2001 03/15/2001 0 PVT PVT ? early URI NONE 1
0168165 04/03/2001 OH 0.6 0 .6 M 03/22/2001 Reported from Mom 3/22/01 RT raise bump size of 50 cent piece, warm to touch, not fussy, no fever, no treatment sought. Mom will call or come in if treatment is sought. U 03/20/2001 03/22/2001 2 none PUB OTH 1
0168166 04/03/2001 OR 0.25 M Crying & irritability times hours. Possible fever Y Y 03/01/2001 PVT PUB none emesis x 1 none 1
0168167 04/03/2001 TX 0.51 0 .5 M 03/27/2001 Mom states in PM of 3/26/01 child non-stop crying, greater than 3 hrs and child was inconsolable. Child seen 3/27/01 by Dr and dx with cough and BSOM and treated. Y N 03/26/2001 03/26/2001 0 PVT PVT Pedicare URI no fever Murmur at birth resolved 1
0168168 04/03/2001 NC 0.75 0 .8 M 03/25/2001 Temp to 101F 36 hrs after Y 03/19/2001 03/20/2001 1 PVT PVT NC01039 1
0168169 04/03/2001 OH 58.0 57 F 03/21/2001 Tired- headache- achy 1st day, 2nd day exhausted & aches everywhere, missed work. Extreme fatigue like never before. Y 07/25/2000 07/25/2000 0 PUB UNK none none none OH0011 1
0168170 04/03/2001 PA 42.0 42 M 03/27/2001 Immediately following vaccines, flu like symptoms, fatigue, joint pain (especially knees) headache, disorientation and ringing ears. Elevated cholesterol, excessive sweating and chills,plantar fascitis, large muscle group fatigue. Treatment on going, dr's care. Follow up: Do not know lot numbers. Vaccine administered by employee, do not wish to question unless required. Y N 10/12/1999 10/13/1999 1 On going full blood work vaccine markers +, Lyme testing +, x-rays, MRI's neg, muscle inflammation +. OTH OTH none 1
0168171 04/03/2001 42.0 42 M 03/21/2001 Pt received shot on 3/8/01 (Anthrax shot #5) and within hours, noted swelling and warmth in the area of injection (left arm) site. ^3cm X 3cm. Area slowly started to shrink but on 3/21/01 at 19:00, pt had acute swelling, papular rash in same area. He was given Ativan 25mg po X 1 with resolution of symptoms. No history of prior adverse reaction to Anthrax. He does have a history of allergic reaction to bee stings in the past. Y Y 03/08/2001 03/08/2001 0 NONE MIL MIL NONE NONE NONE 1
0168172 04/03/2001 IN 36.0 35 M 03/27/2001 3 days, post vax of Anthrax #1, pt developed giddiness; no fever. Evaluation revealed sinusitis. It was treated with antibiotics and corticosteroids. The follow-up states that the patient is not fully recovered,"dizziness symptoms no longer present but still takes Allegra for allergy symptoms." Y 02/11/2000 Sinus CT scan; Sed rate (6 months later)-2 MIL MIL NONE NONE NONE 1
0168173 04/03/2001 MD 6.0 0 .5 F 03/28/2001 Developed varicella on 3/27/01. Y 03/29/1995 03/27/2001 2190 PVT PVT NONE NONE 1
0168174 04/03/2001 PA 1.25 1 .3 M 03/26/2001 Pt received MMRII vaccine on 3/12/01. Was being treated for otitis media with Augmentin. On day 8, (3/20/01) pt developed fever of 102F and erythema multiforme with rash and swollen hands and feet. Required treatment with prednisone and antihistamine. Condition resolved in 5 days. Y 03/12/2001 03/20/2001 8 Hematocrit-30.2; WBC-6.3; Neutrophils 50; Lymphocytes-50; Platelets-365,000 PVT PVT Augmentin Left otitis media NONE 1
0168175 04/03/2001 FL 1.25 1 .3 F 03/27/2001 Rash; resembles measles for 5 days and a fever of 104F for 3 days. Y 02/20/2001 02/28/2001 8 PVT PVT NONE Allergies to amoxicillin 1
0168176 04/03/2001 TX 1.0 1 .0 M 03/16/2001 Splotches on face and stomach about 2-3 hours, post vax. Y 03/16/2001 03/16/2001 0 NONE PUB OTH NONE Sniffles Child gets "sick" often. 1
0168177 04/03/2001 VA 2.0 2 .1 M 03/21/2001 On 3/15/01, had DT Pediatric, Hib, IPV and MMR. Within 1 hours, post vax, had full body hives. He was treated with Benadryl and Ora Pred. Symptoms resolved on 3/19/01. Y Y 03/15/2001 03/15/2001 0 PVT PUB NONE RAD which is ongoing but no wheezing that day Seizure disorder ?; RAD 1
0168178 04/03/2001 AR 1.08 1 .1 M 02/01/2001 Mother states that child had temperature of 106F, post vax, but can't remember if it was day of immunizations or the day after. Mother gave Tylenol and Motrin for fever and placed child in tepid bath. No seizure activity. Mother cannot remember details clearly and doesn't remember how long fever lasted. Did not seek medical attention (per telephone call with RN). Y 12/29/1998 12/30/1998 1 NONE PUB PUB NONE NONE NONE AR1901 1
0168179 04/03/2001 DC 4.0 4 F 03/14/2001 Abscess at site of injection, 48 hours later. U 03/12/2001 03/13/2001 1 PVT UNK 1
0168180 04/03/2001 NJ 4.0 4 M 03/28/2001 Very swollen red upper third of left arm, warm to touch. Y U 03/27/2001 03/28/2001 1 PVT PVT Augumentin prolonged URI NONE 1
0168181 04/03/2001 OH 3.0 4 F 03/20/2001 Pt developed swelling around injection site, had 10 x 10cm area of erythema, induration, tenderness. Y 03/12/2001 03/13/2001 1 OTH PUB NONE NONE 1
0168182 04/03/2001 CA 8.0 8 F 03/14/2001 Swelling and redness of L arm, approximately size of a silver dollar. U 03/07/2001 03/08/2001 1 PVT OTH 1
0168183 04/03/2001 UT 7.0 1 .5 M 03/29/2001 Child exposed to sibling with chicken pox 2 weeks ago. Now has developed low grade fever and about 200 lesions in past 3 days. 05/23/1995 03/26/2001 2134 PVT PVT upper respiratory infection ~Varicella (Varivax)~1~7.00~In Patient|~Varicella (Varivax)~1~4.00~In Sibling 1
0168184 04/03/2001 NY 0.56 0 .6 M 03/10/2001 Pt presents with generalized hives contacted Dr, advised Benedryl Q6H prn. Y 02/12/2001 02/13/2001 1 PVT PVT 1
0168185 04/03/2001 NC 45.0 45 F 03/29/2001 Developed rash, redness across chest, arm and face within 2 hours of receiving injection. Given benadyl and Zantac at ER. Y Y 03/27/2001 03/27/2001 0 OTH OTH 1
0168186 04/03/2001 ME 7.8 2 .9 M 03/29/2001 No data provided. N 03/22/1996 03/28/2001 1832 PVT UNK 1
0168187 04/03/2001 NC 4.0 4 F 04/12/2001 Cellulitis 48 hrs after vaccine in left arm. Tx with Zithromax with good response. Y Y 03/28/2001 03/30/2001 2 PVT UNK 1
0168188 04/03/2001 PA 4.0 4 F 03/29/2001 Developed large erythematous local reaction from shoulder to elbow, which developed on night of and morning after vaccine. No systemic symptoms. resolved within 24-48 hrs. Y 03/21/2001 03/21/2001 0 PVT PVT 1
0168189 04/03/2001 MO 1.4 1 .4 F 03/26/2001 Child experiencing generalized malaise, temp 101.2, nausea and vomiting, rash top of foot red raised non pruritic. Y 03/14/2001 03/21/2001 7 PVT PUB MO2001019 1
0168190 04/03/2001 WI 29.0 29 F 03/15/2001 Syncope, fainting, clonic seizure activity within 5 min of immunization. Y 03/14/2001 03/14/2001 0 PUB UNK Syncope~Td Adsorbed (no brand name)~3~28.00~In Patient 1
0168191 04/03/2001 OR 70.0 70 F 03/29/2001 Swelling and pain started within 1/2 hr after shot given - extreme by night fall. Advised to use ice and aspirin. Red blotches appeared on entire upper arm following day. Chills the first night. Pain replaced by itching after 2 days. All symptoms gone after a week. Y 02/27/2001 02/27/2001 0 PVT OTH Estinyl, Ogen cream,benadryl Allergies: pollens, house dust, Clindamycin, some foods 1
0168192 04/03/2001 NC 45.0 45 F 03/15/2001 3/14 felt funny tired, 3/15 am passed out BP dropped arm red and swollen to ER, 3/16 back to ER c/o chest pain, weakness, headache, put on heart monitor. A follow up report received 1/8/2003 adds: It was reported that a pt (3 of 5) received an Imovax Rabies ID vaccination on 03/14/2001. Reportedly the pt developed a headache, sore muscles, and a local reaction. Further info is requested. From telephone conversation on 04/06/2001, it was reported that the pt recovered from this experience. From additional correspondence received on 04/18/2001, it was reported that the pt did not experience nightmares or insomnia. On 03/14/2001, the pt felt "funny" in the evening. During the morning of 03/15/2001, the pt passed out at home. 911 was called and pt was taken to the ER. The pt's BP was decreased and developed an injection site reaction. The pt left from the ER feeling weak and her was red and swollen at the site. On 03/16/2001, the pt went back to the ER, stayed for 8 hours: pt was put on heart monitor, complained of chest pain, weakness and headache. From additional correspondence received on 05/21/2001, the required ER/doctor visit was marked in box 8 of the VAERS form. "Reviewed 05/14/2001. Emergency Room Visit Summary can be secured. Follow-up #1 - No further info was provided from mailed correspondence received on 06/25/2001. This case is closed. Y 03/14/2001 03/14/2001 0 PUB PVT Prilosec 1
0168193 04/03/2001 IL 53.0 53 F 03/22/2001 Within 24 hrs my arm became very sore and I started to feel as though I was getting the flu. I became very lethargic and weak and later that evening very chilled, the chilled effect last most of the night and by morning it subsided. I still felt very weak the entire next day but by the third day I was feeling fine but still had a sore arm. I never remember having any reaction ever before with any vaccine. Y 03/19/2001 03/20/2001 1 OTH OTH 1
0168194 04/03/2001 TX 0.4 0 .4 M 03/30/2001 Cried for 24 hrs continually, rt leg swollen. Y 02/13/2001 02/13/2001 0 PVT PUB GERD 1
0168195 04/03/2001 NY 6.0 2 .1 F 03/27/2001 Pt started with rash on back which increased overnight, presented in office on next day with 2 circular areas around size of silver dollar. Vesicular lesions which were painful and itchy. No history of varicella. no specific treatment required. Y 05/07/1996 03/21/2001 1779 PVT PVT 1
0168196 04/03/2001 MA 4.0 4 M 03/21/2001 Swelling, warmth, tenderness at injection site. Y 03/15/2001 03/16/2001 1 UNK UNK Asthma 1
0168197 04/03/2001 PA 59.0 59 F 03/27/2001 8 days post vaccine, pt presented with 1 day h/o wheezing and local induration at site of injection. Y N 03/19/2001 03/26/2001 7 peak flow=250 PVT PUB Metformin, calcium,Lipitor, Cozaar, hctz, Claritin HTN, DM II, Hypercholesterolemia, osteoarthritis, allergic rhinitis 1
0168198 04/03/2001 IN 20.0 20 F 03/23/2001 Hep B injection given, approx 30 min later pt c/o dizziness, sore jaw and lower teeth. Nausea approx 3 hrs later c/o slight SOB after walking 100 yards, also c/o pain at injection site L deltoid and down entire L arm. Labs done. Phenengan 25mg given. Y U 03/23/2001 03/23/2001 0 CBC, SMA-7, ABG PVT PVT Dizziness, sore jaw and teeth, L arm sore NKA 1
0168199 04/03/2001 NY 32.0 32 F Onset chest tightness approx 10 min post HBV, 10:45 BP 80/64,pulse 50 reg, R 12,lungs CTA, no wheezing, itching, rash, no edema. 10:50 epinephrine IM, 911 called,pt felt relief in chest, BP 80/64, P 64 reg, R 12, 11:02 BP 104/58,P64, 11:05 P88 lungs clear. 11:12am EMS arrived pt transported to Yonkers Gen ER. Y Y 03/09/2001 03/09/2001 0 03/09/2001 PUB PUB Flagyl Bacterial vaginosis 1
0168200 04/03/2001 OR 50.0 50 M 03/19/2001 Tenderness at injection site,something down deep, throbbing pain radiating from shoulder to elbow. U 03/08/2001 03/10/2001 2 PUB PUB + Hep C 1
0168201 04/03/2001 CA 54.0 53 F 03/22/2001 Post vaccine approx 10-15 minutes later pt started feeling funny, she developed rash, dry mouth and felt like she had a hard time swallowing which lasted several hrs, she was nauseated. Symptoms lasted 24 hrs then she felt ok. Y 02/08/2001 02/08/2001 0 PUB PVT at the end of a cold Allergies to PCN, antihistamines 1
0168202 04/03/2001 OR 6.0 6 M 03/16/2001 Pt developed a generalized varicella rash all over body, with no fever and two small areas of psoriasis. 02/21/2001 03/12/2001 19 NONE PUB PUB NONE NONE NONE OR200112 1
0168203 04/03/2001 MT 1.3 1 .4 F 03/27/2001 Per farther, pt fell bumping right knee and when picked up, pt arched her back stiffly, groaned, then went limp in forward slump for several moments. Pt regained normal wakeful behavior when parent thumped gently on the back. Pt experienced a similar episode later that same day. Two days later pt bumped her head, and experienced the same seizure type activity. Unable to take temperature. Y Y 03/20/2001 03/21/2001 1 NONE PUB PUB Tylenol URI, teething, fever fetal alcohol syndrome 1
0168204 04/03/2001 KY 57.0 57 F 03/27/2001 Pt experienced shortness of breath and swelling of right deltoid 2 hours after leaving clinic. Treated with Benadryl. Pt continues to have shortness of breath one week later. Y 03/21/2001 03/21/2001 0 PUB PUB NONE NONE KY2001022 1
0168207 04/03/2001 ME 40.0 40 F 03/25/2001 Pt experienced left upper extremity pain with swelling into left hand persisting for 4 days. Pt also developed erythema at injection site. Y 03/16/2001 03/16/2001 0 NONE UNK PVT Paxil NONE NONE ME01010 1
0168208 04/03/2001 CA 4.0 4 F 03/29/2001 Approximately 30 minutes post vax, the pt developed a pruritic, erythematous, maculo-papular rash, facial swelling and mild wheezing with increased work of breathing. Treated with oxygen, epinephrine and Benadryl. Y U 03/29/2001 03/29/2001 0 PUB PUB NONE NONE allergy to eggs 1
0168215 04/03/2001 GA 1.5 1 .5 M 03/15/2000 Subsequently starting on 2/17/00, the pt experienced significant local swelling (twice as big), hot to the touch, redness, pain and tenderness at the injection site. He could not walk. The most recent information received on 2/18/00 reports the outcome of the pt as resolved. Y 02/17/2000 02/17/2000 0 OTH OTH 20000053251 1
0168227 04/03/2001 GA 4.0 F 04/26/2000 One hour post vax, the pt experienced a red, swollen (softball size) leg which was warm to touch. The pt said it was painful. A doctor visit was required. Parent was instructed to use ice packs and Tylenol. Swelling was focal around injection site. No fever, crepitus or drainage was noted. As of 04/04/2000, no follow-up was received. Y U 03/29/2000 03/29/2000 0 OTH OTH Zyrtec, antihistamines Allergic to Augmentin 20000117551 1
0168228 04/03/2001 NY 5.0 F 04/28/2000 One day post vax, on 4/5/00, the pt experienced swelling, erythema and induration at the injection site which increased in size. At the time of the report, the pt had 11 mm induration 50 mm erythema and the site was firm and hot. An ER room or doctor visit was required. No treatment was given. The most recent information received on 4/7/00 reports the condition of the pt as ongoing. Y N 04/04/2000 04/05/2000 1 OTH OTH 20000120741 1
0168255 04/04/2001 NY 70.0 70 M 03/26/2001 On 11/09/00, the patient had a flu vaccine. On 12/27/00, the patient had tingling and prickly feeling in his hands and feet. On 12/28/00, the patient went to the doctors office with decreased feeling in his feet. He made an appt to see the neurologist on 01/02. On 12/29/00, the patient had difficulty waking, with decreased feeling in his legs and feet, and loosing balance. On 12/30/00, the patient called the doctor because loss of sensation was progressing up his legs, arms, and hands. He had difficulty sleeping because of discomfort. 12/31/00, the patient had numbness progressing in his thighs to his hips. The doctor sent him to the ER where he was seen by a neurologist. He was sent for an MRI and return was admission to ICU. On 01/05/01, the patient improved some and was discharged. He was able to use the walker with difficulty. He was evaluated by PT. He had therapy on 01/15,01/18, 01/22 and 01/25, condition declining, he was getting weaker. 01/16/01, More medication was ordered to be given at home for 3 days, an RN came to the house and stayed during treatment. 01/20/01, he felt a little improved. 01/22 & 01/25/00, the patient had PT. 01/26/01, his condition was worse, unable to go upstairs, or walk with a walker without falling. On 01/30/01, he saw a neurologist and was taken to the ER and was admitted and evaluated by referring doctor. The patient was given plasma phoresis prescription on 02/01, 02/02, 02/03, 02/04, 02/05, and 02/07. He had a nerve testing on 02/11 no improvement. On 02/12/00, he was transferred to another hospital via w/ch van for rehab. He had 1 hour of PT in the AM and 1 hour of OT in the PM. The patient's condition continued to decline. His appetite was poor, he had difficulty swallowing, weight decreased, because he became weaker each day, not eating. 02/20/01, The doctor was notified and the patient was transferred back to the ICU at the original hospital. On 02/21/01, more meds and had a nasogastric tube inserted for feeding. His weight declined from 175 - 137. Still no movement in his legs, moving fingers; continued to improve. On 02/28/01, the patient was transferred out of ICU to a floor unit. He was moving his hands and his arms; able to hold a newspaper. On 03/01/01, doing better, getting OT & PT. Still NPO. Test showed inversion of epiglottis. On 03/02/01, moving arms, able to make a fist, NG tube out and stomach tube inserted via abdomen, sleeping poorly, breathing test improving. On 03/06/01, very lethargic, slept most of the day. 03/08/01, depressed, complains of weakness of arms and legs. Had a sonogram of his leg. 03/09 and 03/10/01 more meds, moving his fingers a little, voice seems stronger.03/11/01, felt like increased strength in his right arm. 03/12/01, he was moving his arms and legs, and able to reach nose. Breathing test 2.6 + 60, chest clear. 03/13/01, weight down to 122, more meds, able to move arm back and forth on tray table (PT). 03/14/01, good spirits, able to move arms and legs but no real control. 03/23/01, patient went home, improving but still unsteady, moving arms and hands, legs still very flaccid. Diagnosed with GBS. Y Y Y 59 Y Y N 11/09/2000 12/27/2000 48 MRI; Spinal Tap; Cat Scan of abdomen; Nerve biopsy; Blood work; Doppler of legs-no clots; Colonoscopy-polyps; 24 hour UA OTH UNK NONE NONE 1
0168256 04/04/2001 TX 64.0 63 F 03/26/2001 He was having breathing problems, bronchitis and developed influenza on 11/17/00, 1 month, post vax. Still sick but doing better as of 3/27/01. 60 day follow-up states the pt still has a slight cough and bronchitis. Follow up: MD's office had no further information. Y Y 10/16/2000 11/17/2000 32 PVT OTH NONE 1
0168258 04/04/2001 OH 41.0 41 F Transverse Myelitis; Over a few days, pt developed complete plegia of legs and sensory level at T2 with bladder and bowel incontinence. This has persisted. Pt also has persistent pain at site of injection. Rash. Able to do self care. Stimulation only was walker in house. Wheelchair when goes out. Tired easily. Transverse myelitis. Y Y N 11/20/2000 11/21/2000 1 MRI of T-spine; MRI brain; Wasting from T2 to T4 UNK UNK NONE NONE NONE 1
0168259 04/04/2001 NY 50.0 50 M 03/28/2001 The pt experienced transverse myelitis in cervical region versus Guillain-Barre. Lumbar puncture showed increased myelin, evolving symptoms, some of which have improved. Persistent paresthesia to the left upper extremity. Cervical lesion on MRI. No hx of MS. Y 1 Y 01/26/2001 02/27/2001 32 Lumbar puncture - increased myelin, lesion at c-spine PVT PVT None NA None 1
0168260 04/04/2001 OH 44.0 44 F 03/28/2001 Within 2 hours post vax, the pt experienced chest pain, left arm pain, EKG changes, low grade fever. These are the symptoms the pt described over the phone. Y Y 5 Y 03/23/2001 03/23/2001 0 EKG OTH OTH Combivent; Flovent; Singulair; Proventil MDI; Procardia XL; Toprol XL; Prinivil XL; Ativan PRN; Vicodin Possible residual abscess tooth Allergy to PCN, Ceclor, erythromycin 1
0168268 04/04/2001 IN 0.3 0 .3 M 03/27/2001 Marked pallor, generalized depression central nervous system, central respiratory depression and cold skin. Diagnosed with hypotensive, hyporesponsive reaction. Y Y 1 Y 01/19/2001 01/19/2001 0 PVT PVT NONE NONE NONE 1
0168269 04/04/2001 SC 0.9 0 .9 F 04/02/2001 2 days post vaccine pt had fever and vomiting. Ran low grade fever and not eating for whole week. Seen by physician on 4/2/01 still not wanting to eat solid foods, only takes bottle. Y U 03/23/2001 03/26/2001 3 PVT OTH 1
0168270 04/04/2001 ME 0.3 0 .4 F 03/29/2001 Report of rash around injection site post vaccine. Y 03/26/2001 03/26/2001 0 PVT OTH 1
0168271 04/04/2001 VA 0.5 0 .5 F 03/23/2001 L thigh bright red huge welt, Hives all over, onset less than 10 minutes post vaccine. Y Y 03/21/2001 03/21/2001 0 PVT PVT 1
0168272 04/04/2001 VA 1.08 1 .0 F 03/28/2001 Red raised lump, non-tender area around injection site. Started 2 wks post vaccine. Hard white head - now resolving, no fever, non-indurated,1cm area on R leg. Follow up: This information was not available-the family could not remember when it started. Y 02/23/2001 PVT PVT 1
0168273 04/04/2001 RI 1.0 1 .3 F 03/19/2001 Developed redness, erythema at injection site. Y Y 01/29/2001 01/30/2001 1 PVT UNK Food allergies 1
0168274 04/04/2001 RI 0.3 0 .4 M Induration at injection site Y Y 02/26/2001 PVT PUB Mild URI Food allergies 1
0168275 04/04/2001 CO 1.6 1 .6 M 03/08/2001 Temp 101F, febrile seizure - 30 seconds tonic/clonic then intermittent tremors for 15 minutes. Postictal drowsy for 1-2 hrs. Y 03/07/2001 03/08/2001 1 CBC,WBC 14.7,171 Neuts/zolymphi/4 mono/2 Eso, ? bands. PVT PVT 1
0168276 04/04/2001 NJ 1.25 51 F 03/30/2001 Reports swelling L thigh, hot, induration 9x3cm pain/tender erythema mass, L inguinal swelling. Y 03/15/2001 03/27/2001 12 PVT PUB 1
0168277 04/04/2001 TX 2.0 2 1 M 03/26/2001 Mother brought child in for TB reading concerned about redness on L thigh. Nurse measured red area approx 45x55cm warm to touch. Pt evaluated by Dr no further tx at this time. Child was vaccinated PCV7 on 3/7/01 reaction noted on 3/9/01. Y 03/07/2001 03/09/2001 2 PUB PUB Cardec DM URI 1
0168278 04/04/2001 TN 0.2 0 .2 F 03/26/2001 2-3 hrs post vaccine had fever 103F, irritable increased sleeping and decreased appetite. Symptoms lasted 24-36 hrs told to go to ER, didn't go because symptoms improved. Y 03/16/2001 03/16/2001 0 PVT PVT URI 1
0168279 04/04/2001 FL 0.6 0 .6 M 03/20/2001 Mom states area around vaccine red and broke out in rash all over body. appears to be roseola rash not reaction. Y 03/16/2001 03/17/2001 1 PVT UNK Lunde reactive airway 1
0168280 04/04/2001 IN 4.0 3 F 02/22/2001 Fever on site of injection. Developed into Acute gastroenteritis. On day 2 had red rash at site of injection. Lasted 48 hrs. Mottled. Y 02/19/2001 02/19/2001 0 PVT PVT 1
0168281 04/04/2001 TX 6.0 6 F 03/28/2001 Pt c/o swelling, warm to touch,and extreme pain radiating up and down L arm; fever, Pt was treated with pain medicine. Y 03/27/2001 03/27/2001 0 PVT PUB 1
0168282 04/04/2001 MI 1.0 1 .0 F 03/29/2001 erythema multiforme - developed several hrs post vaccine. resolved 4 days later Y 03/21/2001 03/21/2001 0 PVT PVT Augmentin Otitis Media- bilateral resolving 1
0168283 04/04/2001 WI 2.0 2 .0 M 03/29/2001 Within 2 hrs post vaccine had temp spike 103F, less than 24hrs repeat evaluation revealed R hip pain. NL CBC. ESR-17, CRProtein, Hip ultrasound negative sign of fluid. Y Y 03/27/2001 03/27/2001 0 CBC nl, ESR-17, CRProtein, Hip ultrasound negative PVT PVT 1
0168284 04/04/2001 AR 1.25 1 .2 M 03/26/2001 Urticarial rash post vaccine, IM Solumedrol, benadryl. Y U 03/22/2001 03/23/2001 1 PVT PVT S/P viral GE w/o dehydration 1
0168285 04/04/2001 TX 1.4 1 .4 M 03/27/2001 Liam seemed fine after the shots - until morning. On the way to school he made strange jerking motions. I was then called 3 hrs later & told that he slept all morning, could not sit up, talk or walk. We went to the ER & they confirmed it was a seizure. Y Y 03/05/2001 03/06/2001 1 CAT Scan, MRI, various blood test (to see if he was ok) PUB PVT 1
0168286 04/04/2001 CO 1.6 1 .6 F 03/26/2001 Left leg erythematous, no induration, no fluctuance, slight warm, Probable cellulitis. Y 03/14/2001 03/16/2001 2 OTH PVT Well baby visit 1
0168287 04/04/2001 CO 1.25 1 .0 F 03/26/2001 Within 8 hrs of vaccine pt developed fever 103.5F, fever lasted 2 days, developed little rhinorrhea, was fussy, had somewhat puffy eyes - all by parent report. Not examined. Treated with antipyretic. Not examined. Y 12/20/2000 12/20/2000 0 PVT PVT mild eczema 1
0168288 04/04/2001 CO 1.5 1 .6 M 03/26/2001 Leg (upper left) red & swollen at injection site - over 8x6cm area - induration, discoloration, warmth at injection site - type 4 hypersensitivity reaction. Y Y 03/12/2001 03/14/2001 2 OTH PVT Well baby visit 1
0168289 04/04/2001 NC 3.0 3 F 03/26/2001 4 hour post vaccine pt developed fever 103.4F, bilateral swelling of lip, SOB and vomiting. Y 03/21/2001 03/21/2001 0 PVT PUB Singular, Albuterol Asthma, gastroschisis 1
0168290 04/04/2001 PA 0.5 0 .5 F 03/28/2001 Child received vaccine on 3/23/01 and on 3/24/01 had red, blotchy rash at injection site: Hives which continued to spread hives systemically. No shortness of breath or stridor. Y Y 03/23/2001 03/24/2001 1 PVT OTH NONE Cow's milk intolerance 1
0168291 04/04/2001 NE 10.0 10 F Redness extending 5cm from area of injection of Prevnar with slight swelling of right arm. Fever of less than 102F. Y Y 03/10/2001 03/10/2001 0 NONE PVT PVT Zithromax Resolving otitis media Allergy to Ceclor; Frequent otitis 1
0168292 04/04/2001 SC 0.3 0 .4 F 03/26/2001 Knot on thigh of both legs the day after immunizations. No redness or edema. Used warm compresses. Y 03/21/2001 03/23/2001 2 NONE OTH PUB NONE NONE NONE 1
0168293 04/04/2001 FL 0.2 0 .2 F 03/30/2001 Uncontrollable screaming for 4 hours, post vax. Treated with Tylenol. Y 01/12/2001 01/12/2001 0 PVT PVT URI NONE 1
0168294 04/04/2001 NE 1.0 1 .1 M 03/28/2001 At 17:46 in ER, post-ictal; temperature 102.6F; pulse 163. Dx'd with febrile seizure. Mother witnessed seizure driving child home from daycare at 17:30. Y Y 03/26/2001 03/26/2001 0 CXR-nml; Chemistry Panel-nml MIL MIL UNK UNK Torticollis 1
0168295 04/04/2001 AL 4.0 4 M 03/29/2001 Mom called approx. 6 hours, post vax, and stated pt awoke from sleep with reddened raised whelps starting on sides. Denied any SOB, choking sensation or trouble breathing. Pt started on Zyrtec. The next day, pt doing better with a rash. Y 03/28/2001 03/28/2001 0 PVT PUB NONE NONE 1
0168297 04/04/2001 ID 38.0 36 M 03/27/2001 Dizziness, vertigo, falling over from standing if eyes closed, hot flashes and early AM weakness. Onset a few weeks after initial Anthrax vaccination. Dizziness slowly resolved. Continued early morning weakness and hot flashes. Normal electrolytes, CBC, thyroid. Neurology consult on 11/17/98; Brain MRI. Follow up: Patient has not recovered from adverse event. Patient experiences hot flashes, body temperature has low tolerance to heat. Patient's current work duty status is full duty. Patient has been evaluated by a physician or health care provider. Patient did receive further shots since reported event, however no effects were taken place." The follow up received on 4/24/01 states hot flashes, body temperature has low tolerance to heat. Y N 09/09/1998 02/01/1999 145 Normal electrolytes, CBC and TSH. Brain MRI on 11/17/98-small basilar artery system MIL MIL NONE NONE 1
0168298 04/04/2001 MT 56.0 56 F 1 or 2 days, post vax, had very bad muscle pain in left arm at shoulder radiating down to elbow and under arm, causing pain, tingling and numbness. Could not lift arm without using right arm for support. Pain has become less severe since February, but is still there. Took much Advil and got cortisone shot in shoulder on 1/12/01, but did not help. U 11/03/2000 11/05/2000 2 PVT PVT NONE NONE NONE 1
0168299 04/04/2001 MN 3.0 1 .1 M 02/22/2001 Mother reports chickenpox, fever of 103F. Has 4 or 5 bumps and had chickenpox vaccine as a baby. She said he had a runny nose and an occasional cough x 2 days. Developed 2 little bumps and had chickenpox vaccine on 2/27/97. Had had fever with this. Exam shows child is alert and cheerful and talkative. He has nasal congestion with scant clear drainage. Has eczematous rash on arms and 2 small vesicular lesions, one on right arm and one on abdomen. Dx: viral illness, possible varicella and eczematous rash. Treat with Benadryl, HC cream and Tylenol. Return if not resolving or if problems. Y Y 02/28/1997 12/13/1999 1018 NONE PVT PVT UNK Has a twin sister 1
0168300 04/04/2001 MO 4.0 4 M 03/20/2001 Pt developed red area approximately 2 cm diameter on right deltoid. Follow up information received indicates no further redness developed and the area is fading in color. Y 03/07/2001 03/19/2001 12 NONE PUB PUB NONE NONE MO2001018 1
0168301 04/04/2001 IL 46.0 46 F 03/06/2001 Pt developed a 1.5 to 2" diameter red, raised itchy area at injection site. Pt treated with Benadryl. 03/05/2001 03/06/2001 1 PUB PVT Estrogen NONE Darvon, dust 1
0168302 04/04/2001 NJ 3.0 2 .9 M 03/13/2001 Two days post vax, the pt was seen in the ER with a fever of 104 and lack of appetite. Pt developed no rash. Y Y 02/07/2001 02/09/2001 2 blood and urine samples taken PUB PUB NONE NONE NONE 1
0168303 04/04/2001 F Pt received rubeola vaccine results showed no evidence of antibodies. U 02/14/2000 02/14/2001 366 UNK UNK 1
0168304 04/04/2001 NY 1.9 1 .0 F 03/29/2001 Pt developed herpes zoster. Follow up: cannot find information. Y 04/17/2000 03/26/2001 343 PUB UNK NONE NONE 1
0168305 04/04/2001 SD 1.5 1 .5 F 03/27/2001 One week post vax, the pt awakened with a rash that looked like measles. It started on the face and eventually affected her limbs and torso. Pt had a low grade fever of 100 - 102.5. The symptoms lasted for two days. Y 03/12/2001 03/19/2001 7 PVT PUB viral infection NONE 1
0168306 04/04/2001 KS 4.0 4 F 03/29/2001 Pt experienced a local systemic reaction to left arm. 03/27/2001 03/29/2001 2 NONE PUB PUB NONE NONE 1
0168307 04/04/2001 GA 4.0 4 M 03/28/2001 Pt experienced a mild generalized rash and was seen in the ER. Treated with Benadryl for 4 days. Y Y 01/16/2001 01/20/2001 4 NONE PUB PUB NONE NONE NONE 1
0168308 04/04/2001 MT 4.0 4 F 03/30/2001 Pt experienced an injection site reaction characterized by redness, heat and swelling to the size of a baseball. Pt advised to treat with heat/cold alternately and Motrin or Tylenol. Y 03/23/2001 03/26/2001 3 NONE PVT PUB Fluoride NONE 1
0168309 04/04/2001 MI 42.0 41 M 03/29/2001 One day post vax, pts arm was red, swollen and sore. Three days post vax, pt seen for PPD results and arm remains red swollen and sore - area approximately 50 mm diameter. Pt reports that previous TD was in 1997. Y 03/26/2001 03/27/2001 1 PUB PUB PPD / Connaught / C0043AA / left arm NONE NONE 1
0168310 04/04/2001 VA 21.0 21 F 03/29/2001 Pt experienced left sided muscle tightness in jaw and was unable to open mouth one day post vax, until massaged. Subsequent to massage, the pt could open mouth but was unable to close mouth completely. Y 03/27/2001 03/28/2001 1 Pt has history of Left TMJ "clicking" in the past PVT UNK OCP's NONE 1
0168311 04/04/2001 AL 43.0 43 F Pt developed hives approximately 20 minutes post vax, accompanied by swelling. Treated with Benadryl. Y Y 03/27/2001 03/27/2001 0 MIL MIL fibromyalgia; yeast syndrome Barium die 1
0168312 04/04/2001 MS 1.25 1 .1 F Subsequent to exposure at a group home, pt developed full blown varicella, with fever, associated right otitis media and early impetigo involving a few lesion right arm, all skin and mucosal surfaces involved. Pt also has otopic dermatitis, no recent topical steroids. Y Y 02/02/2001 03/22/2001 48 WBC 11-2 (65%L 27% G) Hb 11.8 plts 387 PVT PUB Zithromax, Lortab, Acyclovir Otitis media; herpetic stomatitis; gingivitis recurrent otitis media; possible allergy to PCN, eczema 1
0168313 04/04/2001 TX 50.0 49 M 03/27/2001 Post vaccine pt developed fever, aches, rash on chest, back, arms and hairline. Y Y 03/12/2001 03/25/2001 13 2/21/01 titer showed non-immune to rubella. OTH PVT Amaryla and accupril high blood pressure, type II diabeties. mountain cedar allergy 1
0168314 04/04/2001 PA 22.0 22 F 03/28/2001 2 hrs post vaccine vomited forcefully, then developed rash that started on forehead and spread to abdomen, back, arms. Y U 03/15/2001 03/15/2001 0 PVT PVT NONE NONE NONE 1
0168315 04/04/2001 MO 7.0 5 F 03/30/2001 Started breaking out on 3/27/01, spots on face, back, chest. Y 02/22/1999 03/27/2001 764 PVT PUB 1
0168316 04/04/2001 WA 4.0 4 F 03/28/2001 Mild induration erythema, 101F fever at injection site. Y 03/26/2001 03/27/2001 1 PVT PUB 1
0168317 04/04/2001 MI 2.0 2 .3 M 03/26/2001 High fever of 101F and was given Tylenol; shaking and jerking (from fever); no appetite; limp and fatigue and heart rate was high. Y Y 03/09/2001 03/10/2001 1 PUB PUB NONE NONE NONE 1
0168318 04/04/2001 MI 35.0 35 M 03/27/2001 Persistent tendonitis supraspiratous tendon, 3 months after injection; not caused by needle but by TD. Y Y 11/04/2000 03/16/2001 132 PVT PVT Ear pain 1
0168319 04/04/2001 IL 1.2 1 .2 M 03/30/2001 Approximately 3" erythematous and edematous area about 3/4" to 1" medial in length at injection site. Treated with applying ice 24 hours then moist heat X 2 hours and observe. Y 03/28/2001 03/29/2001 1 PVT PVT NONE NONE NONE 1
0168320 04/04/2001 FL 3.0 1 .1 F 03/28/2001 20-30 erythematous lesions with central papule. Dad dx'd with varicella 10-14 days after child's breakout. Y 10/16/1998 03/20/2001 886 PVT PVT NONE NONE 1
0168321 04/04/2001 MA 1.5 1 .3 M 03/29/2001 On 12/29/00, mom reports 104F (R) temperature. Child cranky and with all over body rash. Pt seen by MD that day for illness. MD noted measles rash on cheeks, lower extremities and soles of feet. Rash blanches; bilateral inguinal nodes and anterior cervical adenopathy. CBC done which showed right shift consistent with viral illness. Y 12/21/2000 12/29/2000 8 CBC-showed right shift consistent with viral illness/done on 12/29/00. PVT PUB NONE Swollen lymph nodes with slight URI symptoms NONE 1
0168322 04/04/2001 OR 25.0 25 F 03/19/2001 Pt experienced rash on chest and face/scalp on 2/27/01 and complained of itchiness and redness, especially on face and scalp. States this lasted about 2 weeks after onset of symptoms on 2/27/01. States she had another bout of facial rash on 3/17/01. (Pt also exposed to chemicals at work site on the same date of 2/26/01). Y Y 02/26/2001 02/27/2001 1 PUB PUB antibiotics for URI (bronchitis) URI Bronchitis (last stages) Asthma, sensitivity to latex gloves OR200113 1
0168323 04/04/2001 OR 12.0 12 M 03/22/2001 Client awoke on the day after vaccines given, 3/21/01, to find his left upper arm, outer aspect, to be inflammed and slightly tender distally to inflammed site. Client assessed at health dept by PHN on 3/22/01 at 10:00. Left upper outer arm noted to have a warm erythematous site measuring 8cm noted. Recommend warm and moist packs alternated with cold packs every 1/2 hour, 4 X a day until improved. OK to use topical hydrocortisone 1% cream. Child's mother was instructed to call PMD if worse or not improving. U 03/20/2001 03/21/2001 1 PUB PUB NONE NONE NONE OR200115 1
0168324 04/04/2001 IL 13.0 14 F 03/27/2001 On 3/27/01, complained of "flu-like" symptoms; nausea, low-grade fever, neck, shoulder and arm pain. Y U 03/26/2001 03/27/2001 1 OTH OTH NONE NONE 1
0168326 04/04/2001 OH 5.0 5 M 03/28/2001 Vaccine on 2/13/01 (varivax). Hives began on 2/21/01 AM. Prelone was initiated on 2/23/01. D/t large response with arthralgias at this pt. Resolving quickly (skin and joints). Y 02/13/2001 02/21/2001 8 UA-neg PVT PVT Amoxicillin (hives on day 8) URI NONE 1
0168327 04/04/2001 MN 1.5 1 .5 F 03/27/2001 3/26/01; Rash on abdomen and spreading to extremities. Y 03/15/2001 03/25/2001 10 PVT PVT NONE NONE 1
0168328 04/04/2001 GA 1.4 1 .4 M 03/28/2001 Dx'd with cellulitis by MD and treated with Keflex. Y Y 03/05/2001 03/06/2001 1 NONE UNK UNK 1
0168329 04/04/2001 CA 35.0 35 F 02/27/2001 After receiving TD injection, while at home, pt developed a rash (localized) itching and pain at the site of injection. Developed cellulitis at site. TD given on 2/20/01. Dx'd with cellulitis on 2/26/01. Treated with Augmentin 875mg X bid X 9 days. Symptoms lasted 7 days, per pt. Y 02/20/2001 02/21/2001 1 Temperature 98.7F OTH OTH Pepcid 20mg Dyspepsia; depression 1
0168330 04/04/2001 WI 4.0 4 F 03/27/2001 had red dots on lips and back; on 3/17/01 and 3/18/01 had diarrhea. Y U 03/20/2001 03/27/2001 7 3/27/01-low platelets PUB UNK NONE NONE NONE 1
0168331 04/04/2001 MS 4.0 1 .6 M 03/28/2001 Mild case (<50 lesions) of papulo-vesicular rash after exposure to sibling (or he and sibling may have been exposed to the same index case). Y Y 01/15/1998 03/25/2001 1165 PVT PUB Intal; Albuterol Mild afebrile viral URI Asthma, recurrent otitis, allergic rhinitis 1
0168332 04/04/2001 MA 48.0 49 F 03/29/2001 Lack of seroconversion-negative titer on 2/16/01. Had Recombivax HB lot 0079J on 5/7/99 and on 6/10/99. U 11/05/1999 02/16/2001 469 Negative Titer-lack of seroconversion on 2/16/01 OTH OTH 1
0168334 04/04/2001 MA 36.0 35 M 03/29/2001 Lack of seroconversion-negative Titer on 2/16/01; repeated on 3/23/01 (different lab)-<2.0. Had Recombivax-HB on 8/13/99 (lot 0256J) and 9/20/99 (lot 0654J). U 02/11/2000 03/23/2001 406 Lack of seroconversion-negative Titer on 2/16/01; repeated on 3/23/01 (different lab)-<2.0. OTH OTH 1
0168335 04/04/2001 MA 27.0 26 M 03/29/2001 The pt has a lack of sero conversion - negative titer on 2/16/2001. U 02/11/2000 OTH OTH 1
0168336 04/04/2001 MA 37.0 37 F The pt had a lack of sero conversion - negative titer on 2/16/01. U 02/11/2000 OTH OTH 1
0168337 04/04/2001 MA 43.0 42 M The pt had a lack of sero conversion - negative titer on 2/16/01. U 04/13/2000 OTH OTH 1
0168338 04/04/2001 AR 11.0 11 F 03/29/2001 The pt experienced a rash on the legs, face, and tummy right after the hepatitis B vaccine. 15-30 minutes post vax. The erythematous rash was located at the thigh, papular and red on the face. Y 03/27/2001 03/27/2001 0 PVT UNK NONE 1
0168339 04/04/2001 WA 86.0 F 03/15/2001 Pt's left arm swelled, was very red and warm to the touch. U 03/13/2001 03/14/2001 1 NONE UNK UNK NONE NONE 1
0168342 04/05/2001 IN 0.3 0 .4 F 04/04/2001 The same day as vax, the pt experienced seizure like activity, came to the office and was transferred to the hospital. The seizure activity lasted about 40 minutes. Y Y Y 04/03/2001 04/03/2001 0 EEG - pending, Heat Ct - nml, spinal tap PVT PVT NONE NONE 1
0168343 04/05/2001 LA 1.5 1 .5 F 04/02/2001 A physician reported that an 18 month old female received vaccinations on 2/8/01. The following day, the child was not ambulating well and was unable to stand. She also had a fever of 101-103F with pain and crying. She was given an injection of an unspecified pain medication with some relief, however, her symptoms returned. On 2/11/01, the child had a rectal temperature of 103F with no nuchal rigidity, nor erythema or induration at the injection site. The reporting physician is currently testing for meningitis. Follow-up information received on 3/20/01, from the child's physician revealed increased red blood cell (13/uL) and segmented neutrophils (4%) found upon exam of cerebrospinal fluid. Total white blood cell count in CSF fluid yielded a normal level of 2/uL. No signs of meningitis were detected. The child was transfused and admitted to another hospital for further evaluation. Note: This report has been upgraded to a 15-day expedited report upon receipt of follow-up information on 3/20/01, which indicated the pt was hospitalized. Y Y U 02/08/2001 02/09/2001 1 CSF-abn; Temperature OTH OTH UNK NONE UNK HQ7116712FEB2001 1
0168344 04/05/2001 21.0 F 04/02/2001 Information has been received regarding a 21 year old female who received a booster dose of TD because of a scrape on her hand from a rusty fence. Three to four days, post vax, the pt began to experience loss of body weight and developed persistent nausea, early satiety, abdominal cramps and vomiting. She was hospitalized and treated with IV fluids. A dx of gastroparesis was made. She was initially treated with metoclopramide and erythromycin and later with cisapride. The pt experienced only mild improvement of her symptoms. Cisapride was replaced by domperidone. She has taken domperidone for 9 months of therapy and her symptoms have improved significantly and her body weight has stabilized. Y U Esophagogastroduodenoscopy; CT Scan; Small bowel follow through-all neg for PUD, gastric outlet and small bowel obstruction. A gastric emptying scan revealed that her gastric emptying was severely delayed with t 1/2 of more than 600 minutes. Antroduodenal manometry showed postprandial antril hypomotility and neuropathic dysmotility. OTH OTH UNK Scrape on hand from a rusty fence UNK HQ8958528MAR2001 1
0168349 04/05/2001 CA 0.4 0 .4 M 02/26/2001 The pt lost speech that had developed at 6 months. Became increasingly uncomfortable, arching back, and screaming for hours after a fever for 3 days following vaccination. FOLLOW-UP information received in an annual follow up report states, " Unable to attend, loss of concentration, uncoordinated, extreme temper, tantrums due to inability to communicate visual sensitive, audio sensitive, immune, system dysfunction." The annual follow-up states "unable to attend, loss of concentration, uncoordinated extreme temper tantrums due to inability to communicate, visual sensitive, audio sensitive, immune sytem dysfunction. This doctor did not react when I had concern. Infact, he almost vaccinated my child again one momth later until I stopped him and seeked better care. My child has suffered and my family has suffered ever since that day. Residual effects are my son had decreased blood flow to the social/comunication part of the brain because of a viral infection he caught when his immune system was compromised from the vaccines. The symptoms were "mimicking autism" and he was diagnosed as such by three doctors, all neuro-pediatricians. MD found the viral infection my son's weakened immune system could not fight." Y Y N 01/10/1997 01/10/1997 0 NIDS Screening-positive for viral infection PVT PVT Amoxicillin Recovering from ear infection NKA Unspecified reaction~DTP (no brand name)~~0.00~In Patient 1
0168350 04/05/2001 CA 1.08 1 .1 F 04/03/2001 This child had a maculo-papular rash 180 noted on 04/01/01, started initially on extremities, then trunk and face. It was initially small, then generalized on the 2nd day associated by fever, itching, and fussiness. N 03/22/2001 04/01/2001 10 NONE PVT PUB Tylenol NONE NONE 1
0168351 04/05/2001 IL 2.0 2 .1 M 03/29/2001 This patient had two febrile seizures on 03/29/01. One at 1:30 AM and one at 5:30 AM. He was seen on 03/29/01 for otitis media. Y Y 03/28/2001 03/29/2001 1 OTH OTH Depakote NONE Seizure disorder 1
0168352 04/05/2001 MI 1.2 1 .2 F 03/28/2001 This child had erythema, induration, swelling, and elevated warmth, of entire right thigh for 1-2 days following DTaP, Hib, and Hep B. Y U 03/27/2001 03/28/2001 1 PVT PVT 1
0168353 04/05/2001 CA 11.0 11 M 03/27/2001 This child had urticaria on the back and upper extremities. The resolved after Epi. Y 03/27/2001 03/27/2001 0 NONE PVT PUB NONE CA010025 1
0168354 04/05/2001 MD 14.0 14 M 04/03/2001 Development of raised, reddened, slightly edematous area approximately 2" diameter. Warm to touch. Responded to applications of ice 20 minutes at a time, for 48 hours. No other treatment needed. Y 03/12/2001 03/14/2001 2 PUB PUB Trazodone, Paxil Depression, Anxiety Allergy to Penicillin, Congenital Bilateral Deafness. 1
0168355 04/05/2001 CA 4.0 4 M 03/27/2001 This patient had hives on his face 20 minutes after vaccinations. He was given Benadryl, the hives resolved by 45 minutes after the vaccinations. His right tricep area also slightly swollen and tender. Y Y 03/27/2001 03/27/2001 0 NONE PUB PUB NONE NONE 1
0168356 04/05/2001 DC 4.0 1 .0 F 04/02/2001 This child had scattered papules on her face and trunk approximately 10 lesions in total, starting to come to a head. Temperature 100. U 08/28/1997 04/02/2001 1313 PVT PVT NONE 1
0168357 04/05/2001 RI 4.0 4 F 03/29/2001 This child had swelling of her hands and redness of the arm administered. Also itching. Immunization given on 03/27/01. Seen in the office 03/29/01, the entire left upper arm. No fever. Y U 03/27/2001 03/27/2001 0 NONE PVT PUB NONE NONE NONE 1
0168358 04/05/2001 TN 1.0 1 .1 F 03/30/2001 This child had a fever by touch, generalized tonic / clonic jerking for 2 -3 minutes, lethargy. Y Y 03/20/2001 03/21/2001 1 CBC - Wnl PVT PVT PPD, Left arm, 02/05/01. Amoxicillin. NONE Pneumonia 3/14/01 (Rocephin and Cefzil). Sinusitis 03/03/01 (Rocephin). 1
0168359 04/05/2001 VA 4.0 4 M 03/26/2001 This patient's left upper arm and shoulder became swollen, red, hot to touch and itchy on Saturday morning. The mother called the PMD. Ice was applied to the area, Benadryl spray was applied, and the child was given Benadryl suspension. Y 03/23/2001 03/24/2001 1 PUB OTH PPD, Connaught, lot # C0153AA, left arm, no previous doses. NONE Allergy to milk. VA01010 1
0168360 04/05/2001 GA 1.4 1 .4 M 04/04/2001 Right mid-thigh with some swelling and superficial erythema. Y U 04/02/2001 04/04/2001 2 PVT PVT NONE NONE NONE 1
0168528 04/05/2001 OH 1.9 1 1 M 09/14/2000 One day post vax, the pts thigh was red and swollen half way down. The pt was treated with Tylenol. No further information is anticipated for this report. The case is closed. Y 08/15/2000 08/16/2000 1 PVT PUB Zantac GERD U2000006800 1
0168530 04/05/2001 CA 1.6 1 .5 F 10/11/2000 Two days post vax, the pt had intermittent and inconsolable crying for over two hours. Further information requested. U 08/29/2000 08/31/2000 2 UNK UNK U2000007180 1
0168531 04/05/2001 NY 1.25 1 .3 M 12/04/2000 Within 6 hours post vax, the pt developed a fever of 103.8F and a local reaction to site 3 X 4 inch red area (site not specified). File to be completed. Y 11/01/2000 11/01/2000 0 UNK UNK PPD / Connaught / C0046AA U2000009050 1
0168532 04/05/2001 CO 5.0 5 F 12/08/2000 Two days post vax, the pt developed an area 17 X 15 cm of the left thigh that was warm to the touch and swollen accompanied by a slight fever. Further information requested. U 10/09/2000 10/11/2000 2 UNK UNK U2000009620 1
0168533 04/05/2001 CO U 12/08/2000 Subsequent to receiving vax, the pt developed a local reaction of redness, swelling and hardness. No specifics were provided. Further information requested. UNK UNK U2000009630 1
0168534 04/05/2001 CO U 12/08/2000 Subsequent to receiving vax, the pt developed a local reaction of redness, swelling and hardness. No specifics were provided. Further information requested. UNK UNK U2000009640 1
0168535 04/05/2001 CO U 12/08/2000 Subsequent to receiving vax, the pt developed a local reaction of redness, swelling and hardness. No specifics were provided. Further information requested. UNK UNK U2000009650 1
0168536 04/05/2001 CO U 12/08/2000 Subsequent to receiving vax, the pt developed a local reaction of redness, swelling and hardness. No specifics were provided. Further information requested. UNK UNK U2000009660 1
0168537 04/05/2001 CO U 12/08/2000 Subsequent to receiving vax, the pt developed a local reaction of redness, swelling and hardness. No specifics were provided. Further information requested. UNK UNK U2000009670 1
0168538 04/05/2001 CO U 12/08/2000 Subsequent to receiving vax, the pt developed a local reaction of redness, swelling and hardness. No specifics were provided. Further information requested. UNK UNK U2000009680 1
0168539 04/05/2001 CO U 12/08/2000 Subsequent to receiving vax, the pt developed a local reaction of redness, swelling and hardness. No specifics were provided. Further information requested. UNK UNK U2000009690 1
0168540 04/05/2001 CO U 12/08/2000 Subsequent to receiving vax, the pt developed a local reaction of redness, swelling and hardness. No specifics were provided. Further information requested. UNK UNK U2000009700 1
0168541 04/05/2001 WA 10.0 10 F 12/22/1999 Subsequent to receiving vax, the pt experienced an increase in tics. U 12/10/1999 UNK UNK Aderall 15mg/day ADD-Attention Deficit Disorder U1999010800 1
0168542 04/05/2001 OR 26.0 25 F 11/29/2001 It was reported that a female pt received a JE-VAX vaccination on 3/14/00. Reportedly sometime after the vaccination the pt developed erythema from axilla to elbow. Additional information is being requested. From Correspondence received on 5/2/00, it was reported, the pt experienced a local reaction to her 2nd JEV vaccination. Onset of itching to site followed by a 50 cent piece size welt and finally enlarging to involve her whole upper left arm from axilla to elbow. All of the skin has peeled. In further questioning, the pt did have "stinging, itchy sensation locally with the 1st injection of JEV." The pt also received a Typhim VI vaccination, the same day as the 2nd JEV vaccination. From follow-up correspondence received on 10/09/01, it was reported that the patient's recovery status is unknown. No further information is available regarding this patient or this case. This case is closed. U 03/14/2000 PVT UNK NONE Pt states history of allergic reaction (urticaria) to erythromycin. Pruritus~Japanese Encephalitis (JE-Vax)~0~0.00~In Patient U200000219 1
0168543 04/05/2001 NY 24.0 24 F 08/24/2000 It was reported that a 24 year old female patient received a JE-VAX and a Typhim VI vaccination on 08/07/00. Reportedly that same day the patient complained of "raised tender area on the dorsum of the right hand 3/4 diameter, looked like a bruise. It was reported that a 24 year old female received a JE-VAX and a Typhin VI vaccination on Aug 7, 2000. Reportedly that same day the pt complained of raised tender area on dorsum of right hand 3/4 diameter, looked like a bruise. Follow up #1 (Sept 24,2002) During internal review of all files, it was deemed necessary to amend the report by updating the adverse event coding. U 08/07/2000 08/07/2000 0 UNK UNK U2000006570 1
0168544 04/05/2001 NY 33.0 33 M 01/15/2001 It was reported that a 33 year old male patient received a JE-VAX and a Hepatitis B vaccination on 08/16/00. Reportedly 4 days after the vaccination 08/20/00, the patient developed itchy, red, and puffy rash over her entire body. She had fatigue, mild dizziness, nausea, swelling of her eyes, lower lips, hands, and joint pain. From additional correspondence received on 10/12/00, it was reported that the patient recovered from this experience. Additional vaccine, patient and responsible physician info was also provided. No further info is expected, this case is closed. Y Y 08/16/2000 08/20/2000 4 PVT PVT NONE NONE U2000006680 1
0168545 04/05/2001 NJ 23.0 23 F 01/15/2001 It was reported that a 23 year old female pt received a JE-VAX vaccination on 10/16/00 at 15:00. Reported in the morning on 10/17/00, the pt noted redness of the face, itching of the face and hives. The pt required treatment with Zyrtec 10mg po every 12 hours. From additional information received on 02/01/01, patient and physician information were updated. N 10/16/2000 10/17/2000 1 OTH PVT Ortho Tricyclen NONE Allergy to Vancomycin U200100066 1
0168361 04/06/2001 NY 0.5 0 .5 M 03/30/2001 The mother found the baby in the crib in cardiac arrest and not breathing suddenly and unexpectedly. He had a tem of 101 in the AM. He was acting fine with good feeding. Y 03/26/2001 N 03/24/2001 03/26/2001 2 NONE PVT PVT NONE NONE NONE 1
0168363 04/06/2001 IA 1.08 1 .1 F 03/23/2001 On 12/94, 4 months or 6 months, the child had a temperature, and didn't make any eye contact for a few seconds. In 02/95, the doctor said if no changes or more symptoms and didn't continue not to worry. On 01/01/96, the child had a high fever 105 - 106 causing prolonged seizure, happened at 2 AM. Taken to the ER then the hospital until 02/06/01. Diagnosed with presumed viral encephalitis. 60 day follow up states patient is unable to walk or talk and cannot take care of herself. Y Y 36 Y Y N 09/12/1995 01/01/1996 111 Lab test for infections. Nothing positive. Spinal taps (2) for meningitis. PUB OTH Tylenol NONE NONE 1
0168364 04/06/2001 PA 1.08 1 .1 M 03/27/2001 The mother reported the shaking of extremities that stopped if she held his hand. The pt was admitted to the hospital to rule out seizure. Neurologist did not think this was a seizure. Y 2 Y 03/22/2001 03/22/2001 0 EEG - nml PVT OTH NONE asthma, allergy to PCN 1
0168365 04/06/2001 PA 44.0 44 M 03/29/2001 Pain in all joint; arthritis-like symptoms every morning since receiving vaccine. Right shoulder still very painful, 24 hours a day. Y N 10/07/1999 10/07/1999 0 Tested for HLA-DR4-I am not OTH PUB shoulder, arm and finger pain NONE 1
0168366 04/06/2001 VA 86.0 85 M 03/22/2001 Pt states arm swelled with red streaks radiating out and developed a fever of 104F the next day. Saw private MD and had increased BP; collapsed/passed out in yard after the doctor visit. Taken by 911 to ER; hydrated and released. ER doctor not sure if vaccine cause of collapse. Pt feels all is related. Y Y Y 02/21/2001 02/21/2001 0 UNK MIL MIL sulindac, ASA, HCTZ, vitamins NONE high blood pressure 1
0168367 04/06/2001 CT 1.25 1 .2 F 04/02/2001 Decreased activity, rash, temperature of 105F, seizure, pharyngitis and poor appetite. Y 1 Y 03/22/2001 03/31/2001 9 WBC-11.4; Blood and Urine cultures (P) PVT PVT NONE Short lingual frenulum 1
0168368 04/06/2001 NJ 0.2 0 .2 M 03/26/2001 Pt had a 7 hour, prolonged sleep on the day of administration of vaccines (DPT shot-1st one) and dx'd with autism at the age of 3 years. Treatment was elimination of pertussis vaccine in the future. Doc 212260, annual follow up states the following: lifetime diagnosis of autism. Also states that ongoing research is needed to investigate link between pertussis vaccine and autism etiology. Y Y U 02/28/1991 02/28/1991 0 PVT PVT NONE 1
0168369 04/06/2001 NJ 65.0 65 F 04/02/2001 On 6/16/00, went to ER; could not put any weight on my right knee. I was given medicine and a shot to ease the pain (ketorolac). Did not associate with Lymerix shot at this time. 60 day follow up states patient has slurred speech, memory lapses, mood swings and difficulty going up and down stairs. Per annual follow-up, doc #214882, patient is still receiving shots in knees, tried therapy, she does not believe it helped. She went to FLA for 2 months, she felt better there. She still has a lot of pain. The left knee is worse than the right one. The follow up received on 6/4/01 states, "5/24/01-no vaccine given unaware of any adverse events." Y Y N 05/24/2000 06/12/2000 19 PVT PVT Premarin, Celebrex, levomyroxine 1
0168370 04/06/2001 NJ 66.0 65 F 04/02/2001 On 7/21/00, the pt went to the ER with excruciating pain in the left knee. Could not walk was given crutches. The pt states (This is when I realize my pain was from Lymerix). 60 day follow up states patient has slurred speech, memory lapses, mood swings, and difficulty going up and down stairs. Y Y N 06/28/2000 07/19/2000 21 PVT PVT Premarin, Celebrex, Levoxyl 1
0168371 04/06/2001 IL 33.0 33 M 03/31/2001 The pt experienced Pemphigus Vulgaris. Y Y N 03/01/1991 03/01/1991 0 biopsy MIL OTH 1984 diagnosed with Grave's disease 1
0168372 04/06/2001 WI 1.59 1 .6 F 01/23/2001 Measles-type rash, especially arms which began on 1/19/01. Was dx'd with Scarlet Fever on 1/12/01. Also, has joint pain, especially in elbows. Y Y 01/04/2001 01/19/2001 15 PVT PVT NONE WI0118 1
0168373 04/06/2001 SC 1.2 1 .2 F 03/26/2001 Received vaccines on 3/13/01. Mother states child broke out with a couple of bumps under left eye, a couple of hours, post vax. Bumps went away that night. States child felt like she had a fever but never checked temperature. Mother states she gave the child Advil. States 3 days, post vax, child broke out with a fine rash over her stomach. Now rash has spread to all extremities. Temperature today is 97.8F with (maculopapular rash). Mother was advised to see PMD. Spoke with mother and called MD's office and was told that rash was from MMR and would clear up in about a week. Y U 03/13/2001 03/13/2001 0 PUB UNK SC0118 1
0168374 04/06/2001 SC 3.0 4 M 03/22/2001 Mom noted hives on stomach, torso and neck when she gave bath at 19:30 on 3/20/01. Pt had redness from shoulder to elbow on right arm. Redness was the size of a 50 cents piece at the top of left arm on 3/22/01. No hives when he awoke on 3/22/01. Arm is still red. Called the doctor and gave Benadryl and Motrin at 02:00. Y 03/20/2001 03/20/2001 0 PUB PUB Zyrtec prn; vitamins NONE Allergy to peanuts, pecans and tree pollen; RSV at 4 months, required breathing treatments until 1998. SC0117 1
0168375 04/06/2001 NC 1.25 1 .3 F 03/26/2001 3" ring of rash around site with a knot under the skin and tender to the touch. Started 24 hours, post vax. Recovered, 4 days after. Told to take Benadryl and use ice on the site. Y 03/23/2001 03/24/2001 1 PVT PVT NONE NONE NONE 1
0168377 04/06/2001 LA 1.0 1 .0 F 03/23/2001 On 3/21/01 at 14:00, mother woke infant from a nap. She was pink in coloration; no response X 2 minutes; disoriented X 1 hour; limp X 2 hours; hypotonic and hyporesponsive until 16:30. At 17:00, doctor dx'd possible pertussis reaction. No treatment. Y Y 03/20/2001 03/21/2001 1 NONE PUB PUB NONE NONE NONE LA010301 1
0168378 04/06/2001 MD 0.3 M 03/30/2001 Seizure-like activity. Y Y PVT UNK NONE NONE 1
0168379 04/06/2001 FL 0.7 0 .7 F 03/29/2001 Pt developed generalized erythematous rash over body about 48 hours, post vax. Y U 03/26/2001 03/28/2001 2 OTH PUB NONE NONE 1
0168380 04/06/2001 MN 0.5 0 .3 M 03/27/2001 Hypotensive and hyporesponsive episode X 3 hours, post vax. Y Y 01/19/2001 01/19/2001 0 NONE PVT PVT NONE NONE 1
0168382 04/06/2001 2.0 3 F 03/05/2001 Approx. 24 hours, post vax, the pt had an unprovoked, brief syncopal episode. She recovered fully. Work-up of episode has produced no etiology. (Syncope occurred at daycare in the AM of 2/21/01). Y Y 02/20/2001 02/21/2001 1 Vital signs-nml; no fever; electrolytes (serum); EKG; CBC; UA-all WNL MIL MIL Resolving RAD-flare (mild) Reactive Airway Disease; recurrent otitis media 1
0168383 04/06/2001 WI 58.0 58 M 01/16/2001 States in mid December and same last year; began with macular scattered rash on entire arms, posterior popliteal to calves and lateral abdomen. Changes to papular; pruritic; open after scratched. No fever. Ruhuli gel decreases pruritus. On 2/1/01, saw MD and was put on prednisone. Y 12/11/2000 12/13/2000 2 PUB PUB NONE NONE NONE WI0119 1
0168384 04/06/2001 AZ 3.0 1 .1 F 03/28/2001 Bumps on body-chickenpox. Y Y 01/11/1999 03/27/2001 806 PVT UNK 1
0168385 04/06/2001 MA 31.0 30 M Sharp pain on right arm at bicep area, flu symptoms, body soreness and headache. U 03/10/2001 03/10/2001 0 MIL MIL NONE NONE NONE 1
0168386 04/06/2001 PA M No data provided. Y U MIL MIL 1
0168387 04/06/2001 PA 1.5 3 F 03/27/2001 Received varivax on 9/14/00. On 3/23/01 had the disease of full blown varicella. Y 09/14/2000 03/23/2001 190 NONE PVT PVT NONE NONE NONE 1
0168388 04/06/2001 TX 1.7 1 .7 F 04/05/2001 Left leg with redness, swelling 4cm and tense. Y 04/02/2001 04/02/2001 0 PVT PUB Claritin; prelone 1
0168389 04/06/2001 ME 1.5 1 .6 F 03/29/2001 Pt developed full body rash X 3 days, post vax, appears like urticaria. Pt Rx'd Pediapred. Rash developed 7 days after 1st dose of amoxicillin and 3 days after last dose. Y U 03/26/2001 03/28/2001 2 PVT PVT Zithromax; Amoxicillin 1
0168390 04/06/2001 WA 40.0 40 F 03/29/2001 Within 5-10 minutes, post vax, was in car driving and became at first, light-headed and then was unable to see (or drive). Was able to pull over and call for EMS. Had to lie on sidewalk just to get air. When medics arrived, I was given oxygen and released, 20 minutes later. Y Y 03/14/2001 03/14/2001 0 PVT UNK Paxil 20mg daily NONE Had suffered a seizure 9 years ago, due to a mixture of anti-depressants. 1
0168391 04/06/2001 PA 54.0 54 F 04/02/2001 Severe stiffness in arm muscle, extending from shoulder down below elbow of right arm and associated pain. Complete spasm as lumping of area, lasted weeks. Y Y 02/11/2001 02/11/2001 0 PUB OTH Prempro; Prinivil; Claritin; Atenolol; Synthroid; Lipitor Knee injury, hands scraped and hurt shoulder Allergy to Compazine, Corbid Sponcule, Macrodantin, Seconal Naldecon 1
0168393 04/06/2001 IL 0.4 0 .5 F 03/22/2001 Infant received vaccines. Grandmother stated infant went "limp" for a "few seconds" and was "red in the face". Infant observed by PHN. Infant responsive and moving all limbs while observed by PHN. Pulse and respiration taken. PMD called. Infant sent to ER per MD. Follow-up call to mother in AM. Infant recovered. ER MD said "possible fainting" per mother. Y Y 03/21/2001 03/21/2001 0 PUB PUB Mylicon, Rondec NONE Allergic to Amoxicillin IL01005 1
0168394 04/06/2001 MN 29.0 29 M 04/03/2001 Pt contacted clinic on 3/29/01 to report progressive arthralgia that began "soon after" the vaccination. He noted swelling and pain, first in his left knee, then his left ankle, then in his right leg and then his arms. He was unsure about fevers. His symptoms seem worse each day and are unrelieved by NSAIDS. He was encouraged to see a PCP soon for further evaluation and treatment. Follow up: Patient did not state the exact date/time. He reports his symptoms began "soon" after the vaccination given. Y U 03/16/2001 PUB PUB NONE Pt reports flu-like symptoms 1
0168395 04/06/2001 VA 76.0 76 M 04/02/2001 Friend of client, called on 4/2/01 and states that 2 days, post vax, pt started "getting slow" and "not himself". 1 week ago, he complained of right arm being "nervous" and saw MD on 3/27/01 because of arm and complaint of being dizzy and problem with thumb and was advised left thumb was probable carpal tunnel. Had surgical removal of a lesion on 3/29/01 that he received secondary to hitting his head on 2/12/01 )on tree limb). He was advised that he needs to see his regular MD for complete evaluation. Y U 03/12/2001 Test for surgery on 3/29/01-"not sure what" PUB PUB BP medicines; Zocor; multivitamins NONE HTN; S/P MI 5/00 with placement of 3 stints. 1
0168396 04/06/2001 UT 1.0 1 .0 M 03/30/2001 Developed varicella despite vaccine on 3/23/98. Y U 03/23/1998 03/29/2001 1102 NONE PVT PVT 1
0168397 04/06/2001 MI 1.0 1 .0 M 03/30/2001 Fever documented at 102.7F, 2-3 hours, post vax. Received antipyretic. Y 03/30/2001 03/30/2001 0 PVT UNK 1
0168398 04/06/2001 IL 1.0 0 .6 F Had febrile seizure, fevers, cyanosis after seizure which quickly resolved. Y Y 11/28/2000 11/30/2000 2 Blood culture-(-) PVT UNK Synagis Viral URI Congenital heart disease with pulmonary stenosis and IVSD. 1
0168399 04/06/2001 SC 17.0 17 F 03/15/2001 Pt wasn't feeling well at 11:30 AM. Went home and did a nebulizer treatment, felt achy and chest tightness. Was seen by NP at a family health center in the afternoon. Peak flow of 380. Was given Benadryl po and another nebulizer treatment. NP does not feel that vaccine caused problem but would like advice as to how to proceed with the next 2 doses. No further problems and she returned to school, the next day. Takes albuterol, Claritin and Singulair. Y Y 02/15/2001 02/15/2001 0 Hepatitis screening done 3/12/01 with negative results. OTH PUB Allergy shots against trees, grass and cockroaches. Allergic rhinitis Asthma SC0116 1
0168400 04/06/2001 NY 43.0 43 F History of bleeding at injection site followed by hematoma and pain and tenderness. Hematoma resolved but mild tenderness and pain persisted at deltoid muscle at hematoma on left arm. Y 03/06/2001 03/30/2001 24 NONE PUB PUB NONE NONE 1
0168401 04/06/2001 MA 4.0 1 .0 F 03/27/2001 Had varivax vaccine on 10/24/1997. Chickenpox exposure at daycare the week of 3/22/01. Seen on 3/26/01 with many vesicles, papules, URI symptoms. Rash very itchy. Y 10/24/1997 03/26/2001 1249 PVT PUB NONE NONE NONE 1
0168402 04/06/2001 WI 13.0 13 F 03/19/2001 13 year old sustained grand mal seizure about 24 hours, post vax of Hep-B #1. Had no illnesses prior to shot. Emesis all day on 3/17/01 until 17:00, then seemed fine. Y Y 03/16/2001 03/17/2001 1 Lamictal blood level drawn on 3/17/01 OTH PUB Lamictal 50mg bid NONE Cerebral Palsy-dx'd at 10 months WI0116 1
0168403 04/06/2001 WI 1.8 1 .9 F 03/07/2001 Rash started on 3/5/01 on face and spread to trunk and legs. Had a fever for 4-5 days prior to rash. (104F tympanic-1 day prior to rash). Itching started on 3/6/01. Legs hurting. Y Y 02/23/2001 03/05/2001 10 PVT PVT NONE Eczema WI0117 1
0168404 04/09/2001 NV 0.2 0 .2 F 03/23/2001 Approximately 36 hours status post vaccination this infant suffered a 15 minute of hypotonia and pallor with unresponsiveness. Spontaneous resolution, no fever, no cough, no rhinorrhea. Y Y 1 Y 03/19/2001 03/22/2001 3 CT of the Head - Nml, EKG - Nml, CBC - Nml, Blood culture - pending. PVT PUB NONE NONE 1
0168406 04/09/2001 NY 5.0 5 M 04/02/2001 About less than 10 minutes, post vax, the pt said he was not feeling good. He was brought back to the examining room and found to be pale and weak. He was put on the supine position, but did not respond well and became bradycardic and very pale; responded briefly to smelling salts and better after an injection of Epinephrine. He remained hypotensive BP 70/40; IV bolus was give an sent to ER by EMS. Y Y 1 Y 03/14/2001 03/14/2001 0 PVT PUB 1
0168407 04/09/2001 PA 75.0 75 M 04/04/2001 This patient received 3 doses of Lymerix following a severe case of Lime Disease. Last dose on 04/04/00. Approximately 1 year later the patient developed severe arthritic pain, particularly in the right knee. The doctor told the patient he would knee replacement; then, 2 1/2 months ago suffered major retina problems in his left eye requiring two surgeries. The annual follow up states, "Since my last report to VAERS and results of muscle pain for my back and legs with difficulties in walking. I have had an MIR of my spinal and then diagnosed with severe spinal stenosis. Right knee replacement in December 2001 and additional left eye retine detachments in 2002 and has had been a good 1-2 years. Y Y 2 N 04/04/2000 04/01/2001 362 X-Rays, injections of pain killers in knee. PVT PVT Vioxx, Celebrex; many eye drops NONE Lyme Disease 1
0168408 04/09/2001 NC 24.0 24 F 04/02/2001 At 09:30, complained of hands and face swelling; 02 at 4L via NC, 911 called, Epi given with no improvement; 2nd Epi given; complained of tongue swelling and was given 50mg Benadryl IM; increased difficulty breathing; 3rd Epi given and transported to hospital via ambulance. Y Y Y 1 Y 03/30/2001 03/30/2001 0 PUB PUB NONE NONE Allergies to PCN, eggs and multi food items 1
0168409 04/09/2001 PA 33.0 32 M This patient had tingly numbness, joint stiffness, neck pain, and joint pain. Per doc 212646, patient still has joint pain, soreness. Y N 04/10/2000 PVT OTH NONE NONE 1
0168410 04/09/2001 NJ 29.0 29 M 03/12/2001 Beginning 10/08 , this patient had unbearable foot and ankle swelling, with pain. He was unable to walk, knee pain, swelling, fever, hives, and a headache. (Significantly worse than any symptoms of Lyme disease prior to vaccination). 60 day follow up states residual symptoms are welts, rash, joint pain and fatigue. Y Y N 10/01/1999 10/08/1999 7 08/05/99 - Positive Western Blot for Lyme Disease. PVT OTH Doxycycline, Zyrtec Lyme Disease with rashes, swollen knees, etc. Lyme Disease 1
0168411 04/09/2001 NE 1.3 1 .4 F 04/02/2001 Information has been received from a registered nurse concerning a female who, "a number of years ago," was vaccinated with MMRII. Subsequently, the patient was diagnosed with autism. Upon internal review, the patient's diagnosis of autism was determined to be an other medical event. Additional information has been requested. Follow-up info was received from the same RN which indicated the pt's mother reported that the child had a 15 month visit that was reported to be WNL. On 3/30/95, at 16 months of age, the child received MMRII (lot 0604A) in the left thigh. On a visit of 5/15/95, it was documented that the child frequently does not respond to loud noise and only has a vocabulary of 1 or 2 words. On 2/15/96, a visit was documented that stated the child was continuing to have developmental delays and language delays. The child was not engaging in social interactions and did not play at this time. On 5/9/96, the physician's office saw the child for her 2 year old well visit and the child was dx'd with a developmental delay, autism. The child was enrolled in a Developmental Program in school. The reporter noted that the mother requested her 2nd child receive MMR as single doses because she saw a piece on a "20/20 television program" and thought that single dose administration could "avoid autism". As of 4/24/01, the mother reported that the autistic child was doing "as well as can be expected". Additional information has been requested. N 03/30/1995 Tympanograms were done-results not in pt's current chart; On 6/7/97, the child underwent lab titers which showed a measles titer of 119.3 (normal 0-15); mumps titer of 3.16 and a rubella titer of 89.2. OTH OTH UNK UNK WAES01033393 1
0168412 04/09/2001 NJ 1.08 1 .1 F 12/17/2001 Information has been received from the mother of a 1 year old female who on 1/9/01 was vaccinated with Varicella virus vaccine live. On 1/13/01, the child developed a fever of 105.5F and had a seizure of 1-2 minutes in duration. Upon internal review, the seizure was considered an "Other Medical Event". The child was taken to the ER where the child was given Motrin. The fever went down to 94F but went back up to 103.7F within hours. At 02:30 the child had a second seizure (2 minutes in duration) and went back to the ER. The child was dx'd with an ear infection and placed on antibiotics. Additional information has been requested. Doc 205592 states that follow up information received from a registered nurse indicated that the child was seen in the physician on 01/17/2001 after a visit to the ER from a seizure on 01/13/2001. It was documented that the child had a viral illness and a febrile seizure. It was noted that the child was afebrile on 01/17/2001, and that a MRI documented in her chart (date not provided) yielded normal results. It was reported that the patient had not experienced any more seizures and has since recovered. Upon internal review, febrile seizure was determined to be an other important medical event. No further information is available. This report no longer meets the criteria for expedited submission. The adverse event of seizure has been chaged to febrile seizure, which is a labeled event. Y Y 01/09/2001 01/13/2001 4 OTH OTH UNK UNK WAES01032899 1
0168418 04/09/2001 NJ 0.08 0 .1 F 06/06/2001 On 12/15/95, the pt received her 1st dose of Engerix-B. Forty days later, on 1/24/96, the pt was hospitalized and dx'd with an intraventricular stroke. She was on life support for the first 7 to 10 days of the hospitalization, which lasted 85 days. Now, at age 5, the vaccinee did not walk or speak and was visually impaired (NOS). She also had a seizure disorder and "global delays" (NOS). She had a "shunt" placed to control hydrocephalus. As of 3/30/01, the outcome of the events is ongoing. On follow-up on 06/04/2001, the vaccine provider stated that the child's chart had been reviewed. There was no documentation of any reaction to immunization in the chart and there was also no documentation in the chart that the child experienced an intraventricular stroke. As of 06/04/2001, the outcome of the event was unknown. Y 85 Y U 12/15/1995 01/24/1996 40 PVT PVT NONE UNK 20010084351 1
0168422 04/09/2001 MA 1.25 1 .0 M 04/04/2001 The pt developed streptococcus pneumonia and then recovered. This case is considered "medically serious". As of 3/30/01, the outcome of the event is recovered. F/U states: On 11/3/00, the child received his 2nd IM injection of Engerix-B and Prevnar. On 1/21/01, 79 days, post vax, the child was "not well" and developed a cough but he was afebrile. A dx of pneumococcal bacteremia was made. The vaccine provider stated that the child had "no adverse event-but failure of vaccine (Prevnar) to protect against pneumococcal bacteremia". The child recovered. Pneumococcal bacteremia is considered "Medically Serious". Y Y 11/01/2000 01/21/2001 81 blood culture 1/21/01-positive for streptococcus pneumonia OTH OTH NONE NONE 20010084251 1
0168424 04/09/2001 ID 4.0 4 M 03/02/2001 The pt experienced a warm, 3 inch area of edema and tenderness. The symptoms began and improved within 3 days post vax. Y 02/20/2001 02/21/2001 1 NONE PVT PUB NONE NONE NONE ID01010 1
0168425 04/09/2001 VA 1.5 1 .5 F 04/05/2001 3 hours post vax, the pt started crying and moaning and then vomited repeatedly for 4 hours. She than began running a fever and the next evening her temp reached 105 and remained so until the next day after the ER visit. Y Y 03/30/2001 03/30/2001 0 WBC - high PVT UNK NONE NONE NONE 1
0168426 04/09/2001 IL 4.0 4 F 04/02/2001 The pt experienced a fever of up to 104.9. Y 03/23/2001 03/25/2001 2 NONE PVT PVT NONE URI-Congestion NONE 1
0168427 04/09/2001 VA 0.3 0 .4 F 12/26/2000 The pt experienced a high fever, was very cranky, and had a staring episode. Y Y 12/19/2000 12/20/2000 1 PVT UNK 1
0168428 04/09/2001 TX 0.3 0 .3 F 03/30/2001 The pt experienced a nodule, non-tender to the left thigh. Y 03/25/2001 03/28/2001 3 PVT PVT NONE NONE NONE 1
0168429 04/09/2001 IA 1.5 1 .5 M 04/02/2001 The pt experienced a fever, woke up in the middle of the night with "burning up", did not check temp. Awakened the following morning with a temp of 102 (ear). The pt was listless, shaky, weak, did not respond to name, Called PMD and was instructed to give Tylenol alternately with Motrin. Symptoms continued until 9:00 am and then was ok except for a continued fever. No further symptoms. Y 03/27/2001 03/27/2001 0 NONE PUB PUB NONE NONE NONE 1
0168430 04/09/2001 CA 1.1 1 .1 F 04/02/2001 The pt experienced a temp late in the afternoon (low grade). That evening it was up to 103. The pt then experienced a seizure for 1 minutes. Was taken to the ER by ambulance. Treated with Pedialyte, Tylenol and Rocephin. Y Y 03/14/2001 03/14/2001 0 NONE PVT PVT Tylenol NONE NONE 1
0168431 04/09/2001 VA 0.2 0 .2 F 03/28/2001 Subsequent to receiving vax, the pt became increasingly lethargic. Three days post vax, the pt experienced a seizure like activity, eyes rolling back, tongue twitching, vomited and fell into a deep sleep and was unable to be awakened. She was pale, limp and non-responsive. Pt was taken to the ER and still did not wake up for the triage nurse. Her heart rate was quite variable from 120 - 180. She finally did awaken about one hour after becoming non-responsive and was seen by the physician. Pt remained groggy and the following day she experienced another seizure like episode, eyes rolling, unable to focus, and then a deep sleep with rhythmic leg jerking. Pt remained groggy/lethargic until 03/26. Pt went from 15-16 hours of sleep per to day to 20-21 hours of sleep per day. The pt had trouble staying awake for more than a few minutes at a time. Y U 03/08/2001 03/08/2001 0 CBC - normal; urinalysis - normal; metabolic panel - normal; CSF analysis culture - normal; MRI - normal PVT OTH Tylenol NONE Premature; reflux; dermatitis 1
0168432 04/09/2001 MD 0.08 0 .1 F 04/02/2001 Pt developed a fever of 103 for 2 days; increased temperature for 4 days. Parent also reports inconsolable crying, agitation, irritability for 4 days. Pts leg was swollen and warm and pt experienced some vomiting. Pt was treated with Tylenol and Advil. Y 01/09/2001 01/10/2001 1 PVT PVT NONE URI NONE 1
0168433 04/09/2001 OH 3.0 3 M 03/30/2001 One day post vax, the pt developed hives, experienced a sore left thigh and a swollen left knee. Seen at the hospital and was told it was a delayed reaction to Prevnar. Hives lasted for 1 week and pain in knee lasted 5-6 days. Y Y 03/23/2001 03/24/2001 1 PUB PUB scalp lesion 1
0168434 04/09/2001 MD F 04/06/2001 Subsequent to receiving vax, the pt began to experienced unspecified symptoms. The reporting neurologist made a diagnosis of bilateral peripheral neuropathy of the feet. As of 03/27/2001 the event is ongoing. Y N 04/01/2000 OTH OTH 20010086051 1
0168435 04/09/2001 MD 0.2 0 .2 M 04/05/2001 1 1/2 hours , after vaccinations, this infant developed an urticarial rash. Y 04/04/2001 04/04/2001 0 PUB OTH NONE NONE Gastrointestinal reflux, history of jaundice. 1
0168436 04/09/2001 CA 4.0 4 M 04/05/2001 This child had swelling, erythema, tenderness, and itching of the right upper arm. Given Benadryl and Hydrocortisone. Y 03/29/2001 03/31/2001 2 PVT OTH NONE NONE NONE 1
0168438 04/09/2001 NC 22.0 22 M 03/28/2001 Acute onset of vomiting, nausea, and shortness of breath after one hour of immunization. The patient also reported drowsiness. The patient received Promethazine Orally. The patient was given 24 hours S/Q. The patient returned to full duty the following day. Y Y 03/27/2001 03/27/2001 0 MIL MIL NONE NONE 1
0168439 04/09/2001 IL 1.6 1 .6 F 04/02/2001 This child had large erythema (from the hip to the knee) at the site if the injection. Y 03/28/2001 03/29/2001 1 OTH OTH NONE NONE NONE 1
0168440 04/09/2001 ID 39.0 39 F 03/19/2001 This patient had swelling of the right knee, noted one day after immunization, she denies injury although she did have surgery on her right knee 6 years ago. She does kick boxing. Y 03/15/2001 03/16/2001 1 NONE PUB PVT Aventis, IPV, T0563, SQ, right arm. NONE Allergic to Penicillin. ID01014 1
0168441 04/09/2001 ID 13.0 13 F 12/03/1999 The mother of this patient states that on 12/02/99 in the evening, the patient had a temp of 104 F, and that on 12/3/99 at 2 PM the patient had a temp of 102 F with Tylenol. The patient also had a slight red swollen area around at the injection site on 12/3/99 at 2 PM. The mother called back 2 hours later and stated that the physician stated the patient had the flu. The doctor gave him antibiotics. On 12/23/99 a call to the mother, the fever resolved after 3 days. Y Y 12/02/1999 12/02/1999 0 NONE PUB PUB UNK UNK ID01013 1
0168442 04/09/2001 ID 0.5 0 .5 M 03/02/2001 This infant had a red, Swollen lump on his right thigh. No fever, no treatment needed. Y 03/01/2001 03/02/2001 1 PVT PUB NONE NONE NONE ID01012 1
0168443 04/09/2001 ID 0.5 0 .5 M 03/05/2001 This infant had red, swollen skin wheal at the site of the injection, on the left thigh. No fever. Y 02/19/2001 02/21/2001 2 PVT PUB NONE NONE NONE ID01011 1
0168444 04/09/2001 IL 14.0 14 F 04/02/2001 This patient had 3 - 4 cm red, raised area with complaints of discomfort to touch, and the area was warm to touch. Y U 03/28/2001 03/29/2001 1 OTH OTH NONE NONE NONE 1
0168445 04/09/2001 VA 4.0 4 M 03/30/2001 This patient had slight erythema and swelling in his left shoulder and upper arm, for 3 days. Y 03/27/2001 03/28/2001 1 PVT PVT NONE NONE NONE 1
0168446 04/09/2001 MO 9.0 9 M 04/02/2001 Approximately 1 hour after his vaccine, the mother states the patient developed a fine rash, not hives, all over his body trunk, and extremities. He had a low grade fever, and vomited for several hours. She did not seek medical attention, and states he was not dehydrated. Reported 2 days after receiving vaccine 3-29-01 and states all symptoms were gone the next day except the rash, and it has faded. Y 03/27/2001 03/27/2001 0 NONE PUB PUB UNK NONE Allergic to Ritalin and Benadryl (as per mom). History of seizures. 1
0168546 04/09/2001 CO 71.0 71 M 04/05/2000 It was reported that a 71 year old male patient received a Typhim VI and a Hepatitis A vaccination on 03/13/00. Reportedly the patient developed a rash on his back and chest two days after the vaccinations, 03/15/00. From correspondence received at Aventis Pasteur Inc. on 04/03/00 "03/29/00, spoke with (patient). He states he called his doctor about the rash and was told that it would resolve within 2 weeks. He was not examined at the time. Today he states the rash is "almost gone" and that he was no longer concerned. I suggested he be examined so that this event would be documented and a description provided. He did not seem to be inclined to pursue this further since he was getting better. Y 03/13/2000 03/15/2000 2 NONE PUB PUB NONE Hyperparathyroidism per patient. U2000001440 1
0168547 04/09/2001 IL 34.0 F 07/13/2000 It was reported that a 34 year old female patient, who is also a doctor, received a Typhim VI vaccination on 06/23/00. Reportedly on 06/26/00, the patient developed joint pain. The patient was not evaluated by a rheumatologist however, was advised by another physician to take Ibuprofen. The Ibuprofen was effective for the joint pain. Further info requested. U 06/23/2000 06/26/2000 3 UNK UNK U2000005470 1
0168548 04/09/2001 GA 19.0 19 F 07/31/2000 It was reported that a female patient received a Typhim VI, a YF-VAX, TD, an IPOL, and a Hepatitis A vaccination on 06/23/00. Reportedly the patient passed bright red blood in her stool approximately 60 hours after vaccinations. Further info is requested. U 06/23/2000 UNK UNK U2000005800 1
0168549 04/09/2001 VA 7.0 M 01/10/2001 It was reported that a 7 year old male patient received a Typhim VI vaccination. Reportedly sometime after the vaccination the patient experienced increased bilirubin and scleral jaundice. No specifics were provided. Further info requested. From additional correspondence received on 10/20/00, it was reported, "Child was in Guatemala when ill. The family reported the patient recovered - has since moved." From additional correspondence received on 04/17/01, it was reported, no further information is available regsarding this patient or this case. This case is closed. Y 06/21/2000 07/04/2000 13 PVT UNK NONE U2000006660 1
0168448 04/10/2001 OK 4.0 4 M 02/27/2001 Complained of petechial bruises. Saw doctor on 8/9/00, 2 days, post vax, with bruises on legs, sores in mouth, blood on lips in the AM for 2 days. No recent illness or tick or insect bites. Swelling 1+ at inguinal nodes and 2+ at axillary nodes; bruises and petechia. Treated with Prelone. On 8/22/00, phone call from mom. She wants to stop sibling from receiving IZ's based on what happened with this son and advised her to speak with the doctor about the advantages and disadvantages and she said she would consider this and call back. Y Y 3 Y 07/19/2000 08/07/2000 19 WBC-4,800; Hgb 12.6; Platelets-9,000 on 8/9/00; on 8/18/00 platelets-468,000 PUB PUB NONE NONE NONE OK0111 1
0168449 04/10/2001 OK 1.25 1 .3 M 02/21/2001 Mom noted whelps, 10 minutes, post vax, and went to the hospital where Grandma worked. When he arrived at hospital his lips were blue and SA O2 reading was 89%. Grandma took him to the clinic immediately, where the pt began to experience SOB. Epinephrine was given in doctor's office and child was admitted to the hospital for 24 hours and Benadryl for the next week. Diagnosed with allergic reaction to MMR Vaccine Y Y Y 12/30/1999 12/30/1999 0 PUB PUB NONE NONE OK0110 1
0168450 04/10/2001 RI 12.0 12 F 04/02/2001 Temperature of 104F, vomiting, red and swollen arm at pneumovax site measuring 4" X 3 1/2". On 3/26/01, admitted to hospital for cellulitis. Y 3 Y 03/23/2001 03/24/2001 1 CBC; Diff; Indices (WBC-increased 21.0) PVT UNK NONE 1
0168451 04/10/2001 FL 0.3 0 .3 M Apnea, bradycardia and seizures, approx. 24 hours, post vax. Intubated and air lifted to hospital PICU. Extubated on 2/21/01. Discharged on Phenobarbital and caffeine. Y Y Y 02/15/2001 02/16/2001 1 CT-nml; MRI-nml; EEG-diffuse changes; various labs PVT PVT Vi-Daylin Apnea of prematurity 24 week Gestation (premie), Apnea of Prematurity. 1
0168452 04/10/2001 MA 40.0 40 F 04/02/2001 2 days, post vax, pt in ER. Pt had developed left arm pain, redness and impaired mobility. Partially recovered. Y Y 1 Y 03/25/2001 03/27/2001 2 NONE PUB PUB NONE Allergic rhinitis, asthma, TAH 1995. 1
0168458 04/10/2001 FL 37.0 37 F 04/02/2001 On 03/26/01 employee in employee health for laceration to the left hand approximately 1 cm from metal trash can. Last record TD 03/17/92. Td consent signed and vaccine given 03/26/01 at left deltoid. Temperature 96.6, cut cleaned, steri strips applied, dressed and splinted. Follow up scheduled for 03/28/01. On 03/27/01, employee called complaining of fever of 100.8. Reported laceration area was not red, swollen or tender. Complained of sore throat and fever, referred to occupational health clinic (OHC) near her work site for evaluation of left hand for possible infection. Follow up paper work from OHC receive via fax had diagnosis of "hand laceration / pharyngitis- strep-NWR" made aware of hospital admission 03/29/01 with possible adverse reaction to TD. Y Y 03/26/2001 03/29/2001 3 NONE OTH PVT Folic Acid, B12 shots, B1, B12 NONE anemia, left hand laceration, allergy to compazine 1
0168459 04/10/2001 GA 27.0 27 F 03/22/2001 This patient received an MMR vaccination at 4:15 PM at about 4:50 PM, the patient returned to the clinic with face swollen, hoarse, complained of "some" chest pain. She had left periorbital edema, right cheek / jaw swollen, injection site raised, swollen, and warm to touch. Immediately to the ER, given Benadryl. She was admitted for observation on 03/22/01, status improved. Y Y 1 Y 03/21/2001 03/21/2001 0 PUB UNK NONE NONE GA01020 1
0168460 04/10/2001 FL 0.2 U Pt experienced a continuous high pitched cry that lasted for 3.5 hours approximately 2 hours post vax. Y PVT PVT acetaminophen NONE 1
0168461 04/10/2001 NC 2.0 2 .6 F 03/19/2001 Pt developed a large area of induration and erythema 21.5 X 9.5 cm. Y Y 03/09/2001 03/10/2001 1 PVT PUB NONE NONE NC01041 1
0168462 04/10/2001 NY 0.75 0 .8 F 03/26/2001 Immediately post vax, redness and swelling noted. Physician treated with ice pack and observed for 30 minutes. No further reaction noted. Y 03/20/2001 03/20/2001 0 NONE PVT OTH 1
0168463 04/10/2001 NY 2.0 2 .1 M 03/26/2001 Pt experienced redness to right arm and swelling. Pt was treated with Keflex, ice for 24 hours and then warm soaks. Y U 03/20/2001 03/20/2001 0 PVT OTH NONE 1
0168464 04/10/2001 NY 1.75 M 03/26/2001 Pt experienced redness and swelling to right thigh. Treated with warm compresses, Benadryl and Augmentin. Y 03/19/2001 03/20/2001 1 PVT OTH NONE cellulitis to face insect bite 1
0168465 04/10/2001 VA 0.25 0 .3 F 04/05/2001 Immediately post vax, the pt went limp closed eyes and was unresponsive, although breathing and heart rate continued. Pt underwent observation and monitoring with follow up the next day. Y 04/03/2001 04/03/2001 0 PVT PUB NONE atopic dermatitis NONE 1
0168466 04/10/2001 WI 2.0 2 .0 M 04/04/2001 Pt experienced fever of 103, swelling, tenderness, and redness at the injection site. Pt initially would not use arm. Treated with Advil and ice. Y U 04/02/2001 04/02/2001 0 NONE PVT PVT Advil URI NONE 1
0168467 04/10/2001 LA 1.4 0 .4 F 03/29/2001 Pt experienced temperature of up to 104 noted for 6-7 hours post vax. Pt still had fever when seen one day post vax. Pt also experienced night irritability. Y N 03/28/2001 03/28/2001 0 slight induration of ? PVT UNK Tylenol URI NONE LA010401 1
0168468 04/10/2001 PA 1.0 1 .0 F 04/05/2001 Pt developed a 1 cm X 1 cm area of erythema ???????????? 03/23/2001 03/23/2001 0 PVT PVT NONE 1
0168469 04/10/2001 TX 0.75 0 .8 F 04/03/2001 Mother reports pt developed wheezing on the same day as administration of Prevnar with DTAP, HIB and HBV on 12/13/00. Same symptoms occurred on 3/30/01 after receiving Prevnar and IPV. On 4/1/01 pt was seen by doctor and dx'd with bronchiolitis and otitis. Y Y 03/30/2001 03/30/2001 0 Physical exam PVT UNK Recurrent bronchiolitis Wheezing~Pneumo (Prevnar)~1~0.00~In Patient 1
0168470 04/10/2001 CA 5.0 5 F 04/05/2001 Pt developed a large sterile cellulitis, 6 X 6 inches in size, red, warm to touch over left thigh after Prevnar injection. U 03/27/2001 03/28/2001 1 PVT PVT 1
0168471 04/10/2001 CA 1.8 1 .9 F 04/01/2001 Pt experienced a very high fever of 102 for about 24 hours that began within 8 hours post vax. Pt also developed a rash all over torso and expe5rienced lethargy. Pt was seen by physician who eliminated the possibility of chicken pox. No treatment was prescribed. Y Y 02/28/2001 02/28/2001 0 PVT PVT ear infection - recovering 1
0168472 04/10/2001 MD 2.0 2 .6 M 04/03/2001 Pt developed right facial Bell's Palsy 26 days post vax. Pt was treated with 7 day course of oral prednisone therapy beginning 03/28/2001; physical therapy began 04/03/2001. Y U 03/01/2001 03/27/2001 26 PVT PUB eczema asthma, eczema, recurrent otitis 1
0168474 04/10/2001 MS 0.3 0 .3 F 04/02/2001 Fourteen hours post vax, the pt developed a fever and became difficult to console with excessive crying. Pt was evaluated in the clinic the following day. Y Y 03/27/2001 03/27/2001 0 urinalysis, blood culture and CBC all normal except for mild anemia PVT PUB NONE fever up to 103 and irritability NONE 1
0168475 04/10/2001 GA 1.2 1 .1 F 03/05/2001 Pt developed a fever up to 103 and parent states she almost had a seizure. Pt was taken to the ER and was advised that it could be from the vax. Parent also advised to treat with Motrin between doses of Tylenol. Fever lasted for 2 days and then resolved. Y Y 01/31/2001 01/31/2001 0 Pt had chest x-ray and blood work in ER which parent states were all negative PUB PUB NONE asthma GA01022 1
0168476 04/10/2001 GA 0.7 0 .7 M Pt experienced a persistent fever for 2 days, persistent crying for 2-3 days and refused foods for 2 days. Y 01/31/2001 01/31/2001 0 NONE OTH PUB NONE NONE NONE 1
0168477 04/10/2001 NY 44.0 42 M 03/17/2001 The pt had a lethargic Feeling, and a sore feeling in knees. U 04/16/1999 06/07/1999 52 PVT UNK NONE NONE 1
0168478 04/10/2001 MA 27.0 27 F 04/09/2001 The pt experienced urticaria, and vertigo. Treated with Prednisone and Allegra. Y U 03/30/2001 04/01/2001 2 PVT PVT Elavil, Celexa neuralgia, GERD, Asthma 1
0168479 04/10/2001 IL 1.0 1 .4 F 04/09/2001 The pt experienced a measles rash over entire body on 4/6/01. The pt had an MMR on 3/27/01. Y Y 03/27/2001 04/06/2001 10 NONE PVT PVT NONE NONE NONE 1
0168480 04/10/2001 IL 1.0 1 .4 F 04/09/2001 The pt had a measles rash over entire body on 4/6/01. The pt had an MMR on 3/27/01. Y Y 03/27/2001 04/06/2001 10 NONE PVT PVT NONE NONE NONE 1
0168481 04/10/2001 OK 13.0 12 M 03/28/2001 Mother states the pt had a rash the night of 8/23/2000 after receiving the Hep A. Was not seen in the ER or clinic. Treated at home with cream. States cleared after 1 week. Y 08/23/2000 08/23/2000 0 NONE PUB PUB NONE NONE OK0114 1
0168482 04/10/2001 OK 69.0 69 F 03/22/2001 One day post vax the pt experienced redness, swelling and warm to touch to the right arm. The size of the redness was approximately the size of a hand. The pt returned to the health department. The pt was instructed to use heat and ice on arm. The pt then saw a PA and was put on Zyrtec for 8 days. On 3/22/01 the pt states that she is better and the symptoms are better. Y Y 03/19/2001 03/20/2001 1 PUB PUB UNK NONE NONE OK0113 1
0168483 04/10/2001 OK 52.0 52 F 02/05/2001 The pt reports left arm swelling, redness with streaks after receiving vaccination. The pt went to the ER for treatment on 1/20/01. the pt was treated with antibiotics. Y Y 01/18/2001 01/18/2001 0 PUB PUB Synthroid, Claritin, Vioxx, Premarin, Prevacid NONE bronchial infections and sinusitis OK0107 1
0168484 04/10/2001 VA 10.0 10 M 04/05/2001 As the pt and his mother were leaving the office the pt became weak and fell. Mom was concerned about the child's breathing. The pt was brought to the exam room observed and monitored for 1 1/2 hours until stable. The pt laid down flat until stable. Follow up next day. Y 01/08/2001 01/08/2001 0 PVT PUB Ritalin ADHD 1
0168485 04/10/2001 CA 16.0 16 F 01/11/2001 The pt experienced numbness on right side of arm also left side of upper back and left leg. U 01/09/2001 01/10/2001 1 OTH OTH NONE NONE 1
0168486 04/10/2001 CA 13.0 18 F 03/29/2001 Shortly after receiving vaccinations, the pt and her father were driving out of the parking lot. The pt's head went back and she passed out in the car. The pt's father carried her in. The parents laid her down, she was seizing. Ammonia inhalants were used two times. The pt regained consciousness and complained of nausea. Her BP was 114/59, pulse was 67 and temp was 96.9. Later the pt vomited and then states "I feel better". The pt left the clinic with no problems. Y 03/29/2001 03/29/2001 0 PUB OTH NONE NONE allergy to all antibiotics 1
0168487 04/10/2001 IN 23.0 23 F 03/30/2001 On 3/26/01, given Rubeola vaccine. On 3/28/01, reports respiratory difficulties, difficulty swallowing, sores in mouth, red spots, itching, nausea and dizziness. Was given Benadryl 50mg IM and 3 25mg caps. for later use. Labs: Strep and Mono were negative. 3/30/01, reports eyes red, irritated and light sensitive. No abrasions. Y Y 03/26/2001 03/27/2001 1 3/28/01-Strep and Mono-negative; 3/30/01-Conjunctivitis OTH OTH NONE NONE 1
0168488 04/10/2001 NJ 4.0 4 F 04/05/2001 About 30 minutes, post vax, pt developed itching, eye swelling and swelling around nose. Also noted to have, blotchy red rash on body. Pt was assessed and was without any airway obstruction. Pt was Rx'd with Benadryl orally with resolution of symptoms within 30 minutes. Y 04/03/2001 04/03/2001 0 NONE PUB OTH PPD/Aventis/C0630AA/RFA Mild URI NONE 1
0168489 04/10/2001 NC 21.0 21 M 04/04/2001 2nd dose of Rabies Imovax given IM on 3/25/01 at 10:15. Pt called nurse at home on 3/26/01 and stated he developed itching, redness, edema and blisters on feet, Sunday night 3/25/01. Also having a dull chest pain that increased with a deep breath. States all symptoms have improved but not completely resolved. RN consulted MD, who recommended changing vaccine manufacturer, which pt received on 3/29/01 without any known problems. Y 03/25/2001 03/25/2001 0 PUB PUB Given on 3/22/01-Rabies Immune Globulin/Bayer/618W01A/8.3cc/Im/divided into each hip/0 previously; Keflex for ear boil infection which was discontinued on 3/22/01 on his own. NONE NONE 1
0168490 04/10/2001 FL 1.0 1 .0 M 04/04/2001 The pt broke out in varicella on both legs and back. Y 01/05/2001 02/05/2001 31 PVT UNK 1
0168492 04/10/2001 WA 0.2 0 .2 M The pt was seen after hours and mom described a fever of 103.2, high pitched crying and vomiting 4 times. Y U 03/20/2001 03/20/2001 0 PVT PUB NONE pyloric stenosis 1
0168493 04/10/2001 MS 1.08 1 .1 M 04/05/2001 On 3/18/01 the pt experienced decreased appetite, on 3/19/01 an elevated temp of 101 - 103, on 3/24/01 saw the pediatrician. Had a few white patches on tonsils. Pediatrician felt the symptoms were a reaction to MMR vaccine. Y Y 03/14/2001 03/18/2001 4 PUB UNK NONE NONE NONE MS01011 1
0168494 04/10/2001 MA 49.0 48 F 04/05/2001 Reaction was due to tuberculosis test. Y Y 04/05/2001 04/05/2001 0 PUB OTH PPD NONE 1
0168495 04/10/2001 UT 6.0 1 .0 F 04/04/2001 The pt's younger sibling had the chicken pox 2 weeks prior to the pt breaking out. At present she has 12 lesions. U 01/18/1996 04/04/2001 1903 NONE PVT PVT NONE NONE NONE 1
0168496 04/10/2001 CA 5.0 5 F 04/05/2001 No data provided. U 04/05/2001 PVT UNK 1
0168497 04/10/2001 MI 16.0 16 M 03/23/2001 On 3/23/01, the pt presented with facial swelling, hives, itching and the feeling of burning. Y Y 03/22/2001 03/22/2001 0 NONE PUB PUB NONE allergy to PCN and bees 1
0168498 04/10/2001 OR 3.0 3 M 03/28/2001 The pt experienced a 6cm of swelling and induration at the injection site. U 03/26/2001 03/27/2001 1 PVT UNK NONE NONE NONE 1
0168499 04/10/2001 NV 26.0 26 M 03/15/2001 The pt reports severe itching and rash over entire body. The rash lasted 2-3 days. Responded to Benadryl. No MD contacted. Y 03/14/2001 03/15/2001 1 PUB UNK allergy to PCN 1
0168500 04/10/2001 RI 10.0 10 F 04/02/2001 At the DT injection site, the pt experienced swelling and enlargement (size of a pancake) on 3/24/01. On 3/29/01 the erythema and tenderness had decreased. Y Y 03/24/2001 03/25/2001 1 PVT UNK PPD / Connaught / 45256220 / LA, SQ 1
0168501 04/10/2001 RI 4.0 4 F 04/02/2001 Erythema and tender. Y Y 03/23/2001 03/24/2001 1 PVT UNK 3/23/01-PPD/00540P/SC/RA/2 previously Cellulitis at left arm secondary 1
0168502 04/10/2001 TN 1.5 1 .0 F 04/03/2001 2 weeks after immunizations pt went to ER with temperature of 103 and small rash all over. Y Y 01/04/2001 02/18/2001 45 PVT PVT NONE NONE 1
0168503 04/10/2001 IN 1.0 1 .0 M 04/02/2001 Pt has scattered lesions on extremities and trunk. Intense diaper rash with lesions. Fever up to 101 F. Y U 03/20/2001 03/27/2001 7 PVT PUB NONE NONE NONE 1
0168504 04/10/2001 MD 15.0 10 M 04/04/2001 Significant Varicella on 3/31/01. Y 04/02/1996 03/30/2001 1823 PVT PVT NONE NONE 1
0168505 04/10/2001 LA 0.2 0 .2 F 04/02/2001 This is a report of an adverse reaction to Comvax given on 1/30/01. The mother reports that within 4-6 hours, post vax, she developed a fever of 102F and redness and swelling of the right thigh. The infant was initially seen in ER late PM on 1/30/01 and dx'd with a local reaction to Comvax. She was treated symptomatically with oral Motrin and Benadryl. The fever resolved over the next 12 hours but the redness and swelling of leg worsened. The parents brought the child back to ER on 2/3/01 to be rechecked. Physical exam revealed no fever, continued redness and swelling of the right leg as well as some induration. The ER physician then consulted child's pediatrician to see child. On my exam, she was fine except for right thigh dorsally with a 4cm X 6cm area of erythema and swelling with a 2cm area of induration. Dx at that time was local reaction to Comvax with mild cellulitis. Infant was treated with oral Duricef. The infant was examined again on 2/4/01 and 2/5/01 with a slow gradual improvement of local redness and swelling. The infant used the leg normally but seemed to have some tenderness especially with motion. The infant did not come for scheduled follow-up appointment on 2/15/01. The parents have been contacted to reschedule the visit. Y Y 01/30/2001 01/30/2001 0 CBC-HgH=9.1; Hct=25.7; WBC=13,300; Plts-704,000 PUB PUB NONE 1
0168506 04/10/2001 NE 1.5 1 .1 M 03/07/2001 Mother reports 3 pox; 1 at forehead hairline mid-line; 1 at middle of back; and 1 at forearm. Filled with fluid, 2 days before scabbing. Received vaccine on 9/28/00 and broke out with chickenpox on 3/5/01. Vaccine did not prevent disease. Y 09/28/2000 03/05/2001 158 NONE PUB UNK NONE NONE NE001 1
0168507 04/10/2001 NE 9.0 9 F 03/19/2001 Had a temperature of 101F-102F within 12-18 hours, post vax, with nausea and vomiting. Phoned family doctor who felt it was flu/cold. By 36-40 hours, temperature was 103.5F and was unable to keep anything down. Was dehydrated and not urinating. Was taken to MD. Labs showed increased alk phos. Pt was given Tigan Supp and Tylenol for Rx. Lesser temperature and nausea and vomiting after the 1st dose. Mother thought it was flu. Temperature down on 3/18/01. MD determined it was a vaccination reaction. Y Y 03/14/2001 03/15/2001 1 Labs included Alk Phos was elevated PUB PUB NONE NONE NONE NE012 1
0168508 04/10/2001 IL 5.0 5 M 03/19/2001 Client awakened approx. midnight, post vax, complaining of itching legs, nausea and vomiting. Child's body was very red, especially legs. Was taken to ER and was completely red on face, trunk, legs and arms. Treated with steroids for allergic reaction. Y Y 03/16/2001 03/17/2001 1 PUB UNK Allergic to Rocephin IL01007 1
0168509 04/10/2001 IL 1.0 1 .0 F 03/07/2001 25 cents-sized area of redness around injection site on left leg. Hardened area about 3 fingers width around injection site on left leg. Temperature 101F, yesterday, 3/6/01. None today, 3/7/01. Area not painful at this time. Instructed to call MD if increased pain or redness at site or if fever returns. Symptoms subsided on 3/08/01. Y 03/05/2001 03/06/2001 1 PUB PUB NONE NONE NONE IL01006 1
0168510 04/10/2001 FL 4.0 4 M 04/04/2001 Pt presented with a acute case of chicken pox, even though the pt was vaccinated. U 09/06/1996 04/01/2001 1668 NONE PVT PVT NONE NONE 1
0168511 04/10/2001 OR 9.0 9 M 03/26/2001 Mom reported on 3/26/01 of pimple-like, red and white head pox to left arm where pt received varicella vax. Verbalizes getting the varicella and Hep-B vaccine to left arm. Verbalized left arm had a quarter-sized bruise, post vax; bruise not present on date of report done on 3/26/01. Verbalizes left upper arm sensitive and painful to touch and continues as of 3/26/01. Mom verbalizes son pulls left arm of shirt up, related to it bothering him at the site. Suggested to call her MD to have rash checked; mom verbalized having called the MD before reporting to health dept. Y 03/14/2001 03/24/2001 10 PUB OTH NONE NONE OR200116 1
0168512 04/10/2001 GA 1.4 1 .5 F 03/05/2001 8-10 hours, post vax, child with fever and vomiting. 18-24 hours, post vax, mother reported child was listless, fever of 104F but vomiting had resolved. Child would awaken when aroused but otherwise, sleeping or lying down. Child not eating but drinking fluids. Y Y 02/28/2001 03/01/2001 1 Blood drawn by MD without significant findings. PUB PUB UNK NONE NONE GA01016 1
0168513 04/10/2001 GA 4.0 4 M 03/05/2001 Pt given DTAP in left leg and MMR and IPV in right leg. Parent back in clinic about 16:30 with child. Child's leg without redness and not warm to touch. Both thighs appear swollen. The areas appear soft to touch. No distress seen. Y Y 03/02/2001 03/02/2001 0 PUB PUB NONE NONE NONE GA01017 1
0168514 04/10/2001 GA 2.0 2 .3 M 02/09/2001 On 2/3/01 at 09:00, mom reports left arm swollen, red and hot to touch. At 14:55 in health dept, left deltoid warm to touch, red area approx. 2" X 2". Mom instructed to apply cool compresses next 24 hours, then warm compresses. Medicine for fever every 4 hours for 24 hours. U 02/07/2001 02/08/2001 1 PUB PUB NONE NONE NONE GA01018 1
0168515 04/10/2001 GA 4.0 4 M 03/06/2001 Raised, red area from deltoid to elbow, approx. 2" across and 4" down. Hot to touch and tender to touch. Mother applied cold compresses on 3/2/01, 3/3/01 and gave Tylenol every 6 hours. N 03/02/2001 03/02/2001 0 PUB PUB NONE NONE NONE GA01019 1
0168516 04/10/2001 GA 15.0 15 F 03/05/2001 On 3/5/01 at 16:00; started with a headache and pain in left arm. The next day, the left side of face was swollen X 1 day. Denies fever today and the arm is still painful and swollen. Also, she still has a headache. Will apply ice and take Tylenol. U 03/02/2001 03/02/2001 0 NONE PUB PUB NONE NONE NONE GA01023 1
0168517 04/10/2001 GA 5.0 5 M 03/09/2001 Noticed swelling of right arm last night (3/8/01). Father states noticeable lump about the size of a half dollar; redness and slightly smaller induration. Child feels find with increased temperature; appetite good and active. Right arm warm to touch and tender to touch. Advised cool compresses and Tylenol and father giving Motrin. To call MD if pain or swelling or no decrease in swelling. U 03/07/2001 03/08/2001 1 PVT PUB NONE NONE NONE GA01024 1
0168518 04/10/2001 GA 4.0 4 M 03/12/2001 On 3/11/01, mid-afternoon, came in house and mother took shirt off to change and noticed his right upper slightly red, no pain per child. Mother did not apply cold compresses as instructed by nurse after giving vaccines. On exam today, site slight pink and warmth; no pain. Y 03/09/2001 03/11/2001 2 NONE PUB PUB NONE NONE GA01025 1
0168519 04/10/2001 GA 4.0 4 F 03/20/2001 Pt started running a fever of 102.5F (oral) on 3/16/01 PM. Right deltoid (DTAP) site started swelling with a small knot. Taken her to doctor's office on 3/17/01 AM and treated with Benadryl and Tylenol. Y Y 03/15/2001 03/16/2001 1 NONE PUB PUB NONE NONE NONE GA01026 1
0168520 04/10/2001 GA 2.0 2 .9 M 03/23/2001 On 3/23/01 at 11:00, first noticed upper arm being red and swollen. Child does not seem to be in pain. Advised cool compresses today and warm compresses tomorrow/right arm. U 03/21/2001 03/23/2001 2 NONE PUB PUB NONE NONE NONE GA01027 1
0168521 04/10/2001 GA 1.3 1 .4 F 03/23/2001 Noted left upper arm was red and swollen while giving the child a bath (size of area was bigger than a 50 cents piece). Doesn't seem to be painful to child. Advised cool compresses today and warm compresses tomorrow. U 03/21/2001 03/22/2001 1 NONE PUB PUB Antibiotic and cough Rx Severe infection with fever NONE GA01028 1
0168522 04/10/2001 PA 5.0 5 M 04/02/2001 Fever of 100F, listless, arm pain and swelling at injection sites. Y 03/30/2001 03/31/2001 1 NONE PVT PVT NONE NONE 1
0168523 04/10/2001 OR 67.0 67 M 04/04/2001 On Monday, 3/26/01, 3 pts showed up at our clinic stating they had very sore arms secondary to their pneumovax shot on Saturday, 3/24/01. This pt was one unusual occurrence sent to you. Pt reported local reaction to shot at upper right deltoid which shows 4" X 4" area of erythema, warmth, soreness but no drainage, fever or chills, etc. Y 03/24/2001 03/25/2001 1 OTH OTH Simvastatin, ibuprofen, fluconazole, allopurinol NONE UNK 1
0168524 04/10/2001 OR 67.0 67 M 04/04/2001 On Monday, 3/26/01, 3 pts showed up at out clinic stating they had had very sore arms secondary to their pneumovax shot on Saturday, 3/24/01. This pt was one unusual occurrence sent to you. Pt stated left deltoid area "red and very sore" until 3/25/01 PM, at which time symptoms rapidly improved. No symptoms on 3/26/01. Y 03/24/2001 03/24/2001 0 OTH OTH prazosin, simvastatin, lansoprazole, warfarin UNK NONE 1
0168525 04/10/2001 OR 72.0 72 M 04/04/2001 On Monday, 3/26/01, 3 pts showed up at our clinic stating they had had very sore arms secondary to their pneumovax shot on Saturday, 3/24/01. This pt was one unusual occurrence sent to you. Started to hurt right after injection. Complained of swelling and discomfort when he uses the arm. Y 03/24/2001 03/26/2001 2 OTH OTH HCTZ, amitriptyline, albuterol, lisinopril, terazosin, KCE NONE Allergies: PCN, erythromycin, codeine, Vicodin, morphine 1
0168526 04/10/2001 CA 4.0 4 F 03/30/2001 Pt received vaccine at 11:30 on 3/28/01. At 15:00, rash appeared on upper back and face. Provider was contacted and they recommended Benadryl every 4-6 hours. Rash disappeared and then re-appeared at 19:00. Contacted provider again and was told to continue Benadryl as needed and use Calamine lotion for itching. Rash still present today but provider not contacted further. No respiratory symptoms. N 03/28/2001 03/28/2001 0 NONE PUB PUB NONE NONE NONE CA010026 1
0168558 04/11/2001 CA 8.0 8 F 04/04/2001 Information has been received from a physician concerning an 8 year old female who on 12/3/98 was vaccinated with the 1st dose of Hep-B. On 1/15/99, the pt developed symptoms of pyelonephritis and HSP (vasculitis). The pt was seen in the office on 1/16/99, 1/21/99 and 1/28/99. The pt was admitted to the hospital "in between this time". The physician noted that the pt was not seen until October (year not provided) for "enuresis exam". It was noted that the pt developed cellulitis in 1999, subsequent to vaccination with Hep-B. The pt was seen on 2/1/00 for a contusion of the eye which was considered unrelated (incidental finding). The pt was again seen in 3/01. The physician felt that the HSP was caused by Hep-B vaccine. No further details were provided. Additional information has been requested. F/U info from the phys indicatd that the pt developed a fever of 100.4F a red maculopapular rash on her legs and swelling of her feet and legs (R leg greater than left). On 1/13/99 or 1/14/99, five wks after the dose of hepatitis B vaccine. An antinuclear antibody titer was negative. She was treated with alex for probable cellulitis. She was also dx'd with pyelonephritis concurrently and was admitted to the hospital for IV fluids and IV alex from 1/16/99-1/19/99. The physician considered the events to be other medical events. Subsequently all of her symptoms resolved. No further info is available. Y Y 3 U 12/03/1998 01/15/1999 43 serum ANA 1/99 negative OTH OTH UNK UNK WAES01033076 1
0168563 04/11/2001 OH 0.3 0 .3 M 04/05/2001 Became fussy and took to doctor. He said it was a virus. Child became worse; went back to the doctor and he had a grand mal seizure and stopped breathing in the waiting room. He was taken to the hospital and almost died from seizures. MR showed cerebral palsy and cortical visual impairment. The 60 day follow-up states cerebral palsy. Diagnosis from hospital: shaken baby syndrome with intracranial hemorrhage, retinal hemorrhage, Traumatic Stupor - Coma Y Y Y 14 Y N 07/12/1995 07/20/1995 8 MR-showed cerebral palsy and cortical visual impairment. PVT UNK NONE NONE 3 months premature at birth; healthy 1
0168564 04/11/2001 NY 60.0 60 F 04/03/2001 A short time after receiving the 1st vaccination, the patient started to have arthritis-like symptoms. A few months later a neurologist said she had "Lyme." The patient received two shots and has since had extreme pain in her knees. Y N 03/25/1999 04/15/1999 21 Blood work-negative PVT PVT Toprol, Indapamide, Prempro 1
0168565 04/11/2001 FL 0.2 0 .2 F 04/09/2001 This infant had a fever of 104 to 105.7, and a seizure (convulsions), JMH - R10, Bacteremia. Y 1 Y 03/27/2001 03/30/2001 3 PVT PVT 1
0168566 04/11/2001 WI 0.4 0 .4 M 04/02/2001 3 - 4 days after this infants vaccinations, the mother stated the child developed RSV and almost had to be hospitalized. Since then he's probably only had about 5 healthy days of his life that he hasn't had URI's. 60 day follow up states patient has persistent ear infections and skin is broken out. The follow up received on 7/3/01 states, "6/15/01 Augmentin susp 400mg/5ml 2.5ml bid x 10 days then re check." Y U 01/16/2001 01/19/2001 3 NONE PUB OTH NONE NONE NONE 1
0168567 04/11/2001 CO 1.2 0 .8 F 04/04/2001 This patient had a fever of 104 F with his first Prevnar. A temperature of 102 F with her second Prevnar (given separately from other vaccines) approximately 2 weeks later. Y 11/27/2000 11/28/2000 1 NONE PVT UNK NONE Cold symptoms (started on 11/29/00). NONE 1
0168568 04/11/2001 OR 1.0 1 .2 M 04/04/2001 This patient had a fever, and irritability 4 hours after his vaccines. He was lethargic, ataxic, for 24 - 36 hours. All symptoms resolved 3 - 4 days. Y 01/25/2001 01/25/2001 0 CBC - Nml, Head CT Scan - Nml. PVT PUB NONE NONE Intermittent viral illness. 1
0168569 04/11/2001 LA 0.3 0 .3 M 04/05/2001 Within 2 hours, morbilliform rash appeared on this infants chest and abdomen lasting 48 hours. No other sickness. Y 03/27/2001 03/27/2001 0 NONE PVT PVT NONE NONE 1
0168570 04/11/2001 FL 0.5 0 .5 F 04/05/2001 This infant has urticaria / hives at 24 hours after taking Prevnar #1 dosage. Lasting for 4 days; severe so Prednisone started for 3 days resolved on Prednisone and 24-36 hours resumed. 2nd Prednisone started 03/23 and rash resolved 03/26. Completely gone 04/05/01. Y 03/14/2001 CBC, CRP - Basically WNL. IGE- elevate 1. PVT UNK NONE NONE 1
0168571 04/11/2001 NJ 0.5 0 .5 M 04/04/2001 Immediately following vaccination, the infant suffered from fever averaging 102 F which fluctuated for the next 2 days, despite use of Tylenol. The infant vomited post intake of bottle (follow up formula) and lunch or dinner meal at least twice a day for 3 days. He exhibited "common mild reactions" of sore leg, fussy, tired and less appetite as well. Y 03/26/2001 03/26/2001 0 Temperature taken via rectal thermometer. PVT OTH NONE NONE NONE 1
0168572 04/11/2001 NY 1.5 1 .5 F 04/05/2001 This patient broke out in a itchy rash similar to 1st reaction. In addition she cried continuously for 2 hours. No local induration. She was advised to take Benadryl. Y 04/04/2001 04/04/2001 0 NONE PUB PUB NONE 1
0168573 04/11/2001 CO 1.03 1 .0 M This infant had a fever of 102.6 on day # 10 after immunizations and had a febrile seizure (2nd time febrile seizure). The patient also had new rhinorrhea and URI sickness. The seizure lasted 30 secs. Y Y 03/19/2001 03/28/2001 9 OTH UNK 1
0168574 04/11/2001 TX 0.75 0 .7 M 04/09/2001 This patient broke out in a rash on the next day. A rash to his forehead, arms, legs, and trunk of the body. The rash lasted 1 week. Y 03/08/2001 03/09/2001 1 PUB UNK NONE NONE 1
0168575 04/11/2001 IL 1.0 1 .0 M 04/02/2001 This infant had redness with erythema of the site, and a whole body rash. The patient became extremely irritable, inconsolable for several hours, and a fever. It took two days for the patient to return to normal. Y Y 03/29/2001 03/30/2001 1 NONE PVT UNK NONE NONE Pulmonary valve repair at birth. 1
0168576 04/11/2001 OK 30.0 30 F 02/07/2001 The following day after her injection, the patient experienced red welts from neck down to her feet, all over her body. Still present this day. The doctor prescribed Prednisone for 2 weeks with no relief. Taking UV treatments, erythromycin, biopsy of welts with diagnosis of Pityriasis Lichenoi'des Acu'ta. Possible chemotherapy in the future. Y N 12/11/2000 12/12/2000 1 Biopsy of welts. OTH PVT Orthocyclen B/C pills NONE Allergic to Codeine, Penicillin, Tetracycline, All childhood immunizations. OK0109 1
0168577 04/11/2001 GA 12.0 12 U 03/23/2001 This patient had a slightly raised red macular lesion on the left upper arm approximately 6-8 cm above left elbow. The lesion was warm and tender to touch,approximately 5 cm in diameter. Y Y 03/21/2001 03/21/2001 0 UNK UNK NONE NONE 1
0168578 04/11/2001 PA 5.0 1 .0 M 04/05/2001 This child had varicella disease despite immunization. Y 10/18/1996 UNK UNK 1
0168579 04/11/2001 PA 6.0 F 04/05/2001 This patient had varicella disease despite immunization. Y UNK UNK 1
0168580 04/11/2001 MO U This patient had swollen lips, sometimes eyes, hives, tired most of the time, joints in the arms and legs hurt when hives appear and sometimes after. N PUB PUB NONE NONE NONE 1
0168581 04/11/2001 GA 61.0 61 F 10/26/2000 According to the patient's sister, the patient complained of severe left arm pain and swelling in the left arm. The patient went to the ER where she received pain medication and her rings were cut from her fingers due to swelling. This patient also received a flu vaccine in the opposite arm from a local grocery store. Y U 10/25/2000 10/25/2000 0 PUB OTH NONE Allergic to Codeine. History of lung problems. GA01021 1
0168582 04/11/2001 MN 5.0 5 F 04/04/2001 This patient's hair is falling out. U 02/19/2001 03/06/2001 15 NONE PVT PVT NONE NONE 1
0168583 04/11/2001 TX 45.0 45 F 04/03/2001 On 3/29 at 6 PM, vocal hoarseness. On 3/29 at 7 PM, headache, and low grade fever. On 03/30 at 7 AM, hives and itching. On 03/30 in the afternoon, University hospital ER. Treatment with steroid injection and Benadryl. On 04/01, pus in throat. On 04/02, prescribed Amoxicillin. On 04/02 in the PM, no fever, no headache, rash almost totally gone. Y Y 03/29/2001 03/29/2001 0 NONE PUB PVT NONE NONE SA0103 1
0168584 04/11/2001 FL 5.0 5 F 04/05/2001 This child had a 13 x 22 cm diameter area of erythema and warmth with few, small blisters centrally on the right thigh. U 04/02/2001 04/03/2001 1 NONE PVT PVT 1
0168586 04/11/2001 WV 0.5 0 .5 M 04/03/2001 This infant had a fever since 03/10/01. Seen in the office on 03/13/01 presented with fever, according to the mother, fussy, fine rash all over the abdomen. Y Y 03/10/2001 03/11/2001 1 CBC, Blood Culture, CRP. PVT PUB NONE 02/13/01 atopic dermatitis. 1
0168588 04/11/2001 NJ 2.0 1 .2 M 04/03/2001 This child developed chicken pox. Y 07/02/1999 04/03/2001 641 PVT UNK NONE Fetal cocaine exposure. 1
0168589 04/11/2001 NM 4.0 4 M 04/07/2001 This child had swelling and redness to the right deltoid area, warm to touch, febrile. Y U 04/06/2001 04/07/2001 1 NONE PVT PUB NONE NONE NONE 1
0168590 04/11/2001 IL 5.0 5 F 04/04/2001 This child had a 8 x 8 cm erythema and induration surrounding her DTaP injection. U 04/02/2001 04/03/2001 1 NONE PVT UNK NONE Mild URI NONE 1
0168591 04/11/2001 AZ 4.0 4 M 03/29/2001 By 3/28 this patient developed redness at the site of his injection, 7 x 12 cm, flat, not tender. No axillary nodes. Y 03/27/2001 03/28/2001 1 NONE UNK UNK NONE NONE 1
0168592 04/11/2001 TX 5.0 1 .0 M 04/03/2001 This child developed varicella 5 years after given Varivax. Y 08/30/1996 03/30/2001 1673 PVT PVT NONE NONE NONE 1
0168593 04/11/2001 PA 5.0 1 .0 M 04/05/2001 This child had a rash. Y 09/30/1996 04/04/2001 1647 PVT OTH NONE NONE 1
0168594 04/11/2001 SC 1.25 1 .3 F 04/03/2001 From 03/22, 6 PM - 3/24, 4 AM, this infant has had a fever of 102 - 104. On 03/23, she had a slight rash (small red dots) on her face that spread to her back and her stomach. On 03/24, you could see white rings around the red dots. The patient visited the doctor on 03/24 at 4 PM. The doctor indicated that it could be varicella. On 03/25 , the rash spread slightly to diaper area, and 1 or 2 on her legs. On 03/26, the rash was gone from her lower body. On 03/27, the rash was gone from her face. Y Y 03/14/2001 03/22/2001 8 PVT OTH NONE NONE NONE 1
0168595 04/11/2001 CO 0.3 F 04/03/2001 The day after her shot, the patient had diarrhea, and inconsolable crying. The 2nd day after her shot, the patient slept most of day. The 3rd day after the shots, the patient had a rash on the front if his torso, hives on the buttocks and post lateral thigh. Bath and take Benadryl. PVT OTH Zantac NONE NONE 1
0168596 04/11/2001 IL 0.3 0 .4 M 04/06/2001 A mother called to report fever of 102 and irritability. Y U 04/04/2001 04/05/2001 1 OTH OTH NONE NONE 1
0168597 04/11/2001 MO 47.0 47 F 04/04/2001 This patient had flu like symptoms. Y 03/23/2001 03/24/2001 1 PUB PUB MO2001020 1
0168598 04/11/2001 CA 4.0 4 F 04/02/2001 This child's left arm was red, swollen, and itchy at the injection site. Y Y 03/29/2001 03/31/2001 2 OTH PUB NONE NONE NONE 1
0168599 04/11/2001 MS 50.0 50 F 03/20/2001 Since this patient had a 2nd "HB" shot, she can't use her left arm at times, where shot was administered. There was a sharp pain to the point of yelling and then she couldn't hardly use her left arm for almost 2 weeks and it still gives her trouble. The 1st shot she had no problem. N 10/19/2000 10/19/2000 0 MIL MIL 1
0168600 04/11/2001 CA 4.0 4 M 04/03/2001 This child had a swollen, red molted area 1/2 around his left arm, warm, no streaks, resp and lungs Nml. Benadryl. Y 03/29/2001 03/31/2001 2 PVT OTH PPD, Connaught, Lot # C0152AA, Left forearm, 1 previous dose. NONE NONE 1
0168601 04/11/2001 CO 1.6 1 .6 M 04/05/2001 This patient was given TriHibit in the left thigh. The night following his immunization the site was red, swollen, hot to touch, itchy, and diameter size of a baseball. The patient was put on antibiotics for treatment. U 04/03/2001 04/04/2001 1 NONE PVT PVT Purulent Rhinitis, Cough, Eczema. 1
0168602 04/11/2001 IL 23.0 23 F 04/04/2001 This patient had a fever with severe pain in the arm that she received the shot in. She could not utilize her arm to put on her clothing. The patient returned to the doctor 5 days later and was told her arm was infected due to the vaccine and was put on an antibiotic. Y Y 02/01/2001 02/01/2001 0 MIL OTH NONE Asthma 1
0168603 04/11/2001 CA 2.0 2 .9 M 04/06/2001 This child had a mild rash on the front and back of his trunk, and mild rhinorrhea. Y 03/08/2001 03/16/2001 8 NONE PVT PUB NONE NONE 1
0168604 04/11/2001 CA 8.0 8 F 04/05/2001 This patient felt weak with shortness of breath, about 5 minutes after the vaccine administration. VSS with good air movement. The patient was given a few sips of soft drink, and 1 tspn of Benadryl. However, the patient still complained of shortness of breath. Epinephrine was given SQ. The patient's symptoms resolved and she was discharged home. Y 04/04/2001 04/04/2001 0 NONE PVT PUB NONE NONE Palpitations 1
0168605 04/11/2001 ND 49.0 49 F 04/02/2001 By Monday (03/26/01) afternoon, this patient's arm was red, and swollen around the injection site. This progressively got worse with redness going all the way down the arm. The patient saw her doctor on 03/30/01 with antibiotic treatment. Y Y 03/26/2001 03/26/2001 0 PUB UNK 1
0168606 04/11/2001 VA 65.0 65 F 04/04/2001 Pt developed a localized reaction. Entire left deltoid area was red, swollen, and warm to touch. Pt denies pain and tenderness. Y 04/02/2001 04/02/2001 0 NONE PUB PUB 1
0168607 04/11/2001 WI F 04/02/2001 On 03/14/01 pt noticed a growing area of swelling, inflammation and pain at injection site. Pt noticed the area growing for 3 days and then sought medical attention. Cellulitis was dx by a MD on 03//9/01. Pt completed a 10 day po antibiotic regimen , Y Y 03/07/2001 03/14/2001 7 PUB PUB NONE NONE NONE 1
0168608 04/11/2001 CA 10.0 10 F 03/08/2001 This child had a fever, headache, achiness an hour after her shot. Y 03/06/2001 03/06/2001 0 NONE PVT PVT Flonase nasal spray NONE NONE 1
0168609 04/12/2001 MD 0.3 M 04/10/2001 A sales representative reported that a 4 month old male received Prevnar, Hib-Titer, Orimune, and Diphtheria, Tetanus and Pertussis on 03/15/01. On 03/16/01, he experienced a seizure which resolved within 20 minutes. The patient was hospitalized that same day and was discharged on 03/19/01. Follow up info was received on 03/26/01 from the sales representative indicated the child developed a low grade fever the day of the vaccination for which the child was given Tylenol. the next day, the child was hospitalized for twenty minute episode of status epilepticus which required treatment with Ativan. Y 3 Y 03/15/2001 03/16/2001 1 CT of head-nml; LP-nml; EEG-nml; Ammonia increased (58); blood electrolytes NOS-nml; blood glucose-nml. CSF-pending; Plasma AA-pending; UA-pending; lactate/pyruvate battery panel-pending PVT OTH UNK NONE UNK HQ8904627MAR2001 1
0168614 04/12/2001 KY 1.3 1 .4 F 03/30/2001 Nodule, redness, swelling of left thigh. Mother treated with compresses and Tylenol for fever. Follow up on 11/06/2003: "Vaccine recipient did recover from the adverse event." Y 3 U 03/27/2001 03/28/2001 1 PUB PUB NONE Rhinitis-Allergic/cold Asthma KY2001023 1
0168615 04/12/2001 KY 1.08 1 .1 M 04/04/2001 Rash, "hive-like" legs, arms, ear, ill and anorexic. Referred to PMD. Transferred to hospital and dx'd with HSP (Henoch-Schonlein Purpura). The follow-up states that after the pt got admitted to the hospital he experienced fever of 102 deg. F. and also refused to bear weight and hands, knees and feet became swollen with increased sleeping and decreased appetite. Rash progressed further to hands, feet, several on face, and non on trunk. Y Y 4 Y 03/22/2001 03/26/2001 4 UNK PUB PUB NONE NONE NONE KY2001024 1
0168626 04/12/2001 WI 4.0 3 F 04/06/2001 10x7 cm localized reaction to the right arm 48 hours post vax. Y Y 04/03/2001 04/04/2001 1 PVT UNK 1
0168627 04/12/2001 OH 52.0 52 M 04/02/2001 The pt experienced an approximately 1 1/4 to 2 inch circle of redness with 1cm hard nodule in the center of circle. The area was sore and warm to the touch. No fever was noted. Y 03/29/2001 03/31/2001 2 UNK UNK BIBE 1
0168628 04/12/2001 CT 58.0 58 F 04/04/2001 The pt received the Lyme vaccine through Yale study 1994-1998 with a history of Lyme arthritis in 1992. Since receiving the vax she has had progressive worsening of the arthritis in her knees with symptoms unresponsive to both PO and IV antibiotics. The reporter feels there is a correlation with this progressive arthritis and the Lyme vaccine. Y 08/01/1999 sed rate - 34, Lyme WB - pos, Igm - 23, IgG - 18,23,39,41, HLA, ANA - neg UNK UNK progressive arthritis 1
0168630 04/12/2001 DE 33.0 33 F 02/14/2003 Following a Lymerix vaccine the pt subsequently experienced "inflamed joints". She was seed by a physician specializing in Lyme disease. He ran some studies on her and concluded that she did not have Lyme disease but was having an adverse reaction to the vaccine. As of 4/01 the outcome of the event is ongoing. Per F/U, on 5/10/99, the pt received her 2nd dose of Lymerix. She experienced no adverse event for approx. 4 months. In 9/99, the pt experienced fatigue, stiff neck, "inflammed joints" and right arm and right hand joint stiffness. She was seen by her physician in 1/00, who reportedly made a dx of "possible carpal tunnel syndrome and seasonal allergies". She returned to the physician's office in 5/00, because of increased neck stiffness. In 7/00, the consumer experienced numbness and tingling in her feet with pain. She also experienced "floaters" (NOS). She was treated with doxycycline. Her symptoms continued and she was seen by an infectious disease specialist in 10/00. Doxycycline treatment was continued. In 11/00, she saw a neurologist. He stated the pt "had possible Lyme". In late 1/01, symptoms started to return. She was seen by a rhematologist who dx'd "possible fibromyalgia". In 2/01, the pt's primary physician dx'd the pt with possible Lyme disease or autoimmune disease (NOS). The pt was subsequently seen by a physician who specialized in "Lyme and related disorders". Unspecified tests for Lyme disease were negative. DNA testing was positive which resulted in a dx of autoimmune arthritis. This physician considered the autoimmune arthritis to be "related to vaccine for Lyme". As of 4/30/01, the outcome of the events was unknown. The follow up states that the concurrent medications included nasal medication, methylprednisolone (Medrol dosepak), pseudo-ephedrine HCl (Sudafed), azithromycin (Z-pak), clarithromycin (Biaxin), gualfenasin/phanylephrine (Exgest LA0, erythromycin, sertraline (Zoloft), fexofenadine HCL (allegra D), allergy shots and loratadine (Claritin). She is allergic to penicillin, has seasonal allergies and multiple other allergies (NOS). Concurrent medical conditions included asthma. She has a history of temporomandibular joint disease (onset 4/1/99), recurrent sinusitis (onset 1997), mild infection of right hand due to cat bite (12/17/98), bronchitis, vertigo, nausea, stomach upset, ear pain, chest and ear congestion, depression, heart palpitations, onset pressure and possible irritable bowel syndrome. She was in a motor vehicle accident on 11/18/00. Family hisotry includes lupus (cousin on father's side) and the mother had Meniere's disease. The statement of injuries reported that the vaccinee suffers from joint pain, in particular she experiences burning in her feet, knees, hands and back. She also suffers from fatigue and flu-like symptoms. The following info was obtained from medical records via the litigation process: The vaccinee was seen by her family physician on 4/12/99 still complaining of left ear pain. The physician noted that the vaccinee requested to be given Lyme vaccine and the first LYMErix shot was given. In addiitona the vaccinee was prescribed Z-pak and was to continue with nasal medication (NOS) and pseudoephedrine HCL (Sudafed). The physician noted that if worses in one month then refer for allergy testing. The vaccinee's family physician wrote a note, dated 4/14/99, to the vaccinee's employer stating that the pt was experiencing fatigue secondary to sinusitis and should be excused from work until 4/19/99. The vaccinee was seen by her family physician on 5/10/99 and was given her second Lyme vaccination. Progress note of family physician on 7/23/99 noted that a MRI had been ordered by the allergist due to the vaccinee's sinusitis. The vaccinee was seen by her family physician on 1/22/00. She complained of a lump on her right hand, second finger, onset three days ago. The physician noted that it was a 3mmx2mm ganglion cyst, non tender. The avccinee was seen by a behavioral health center on 3/14/00. She was diagnosed with adjustment disorder with mixed emotional features and dysthymia. She was prescribed Zoloft 100mg daily. The vaccinee was seen by her family physician on 7/24/00. She complained of ongoing fatigue for the previous two to three months. The physician noted that the vaccinee had "been off periods regular... has had no aches or fevers, no thyroidmegaly" and that her impression was "fatigue of uncertain etiology." She scheduled the vaccinee for complete blood count, thyroid stimulating hormone, T4, chemical panel and sedimentation rate. The vaccinee was seen by her family physician on 8/7/00 complaining of flu-like signs and symptoms of tingling in the arms and legs and continued tiredness. The family physician noted that the vaccinee was scheduled the following month on 9/7/00 for "double strand DNA, C3, C4 and CHSO." Neurological exam was "intact" and it was ntoed that the pt was to get a MRI of the brain and x-ray of spine and" may need to see neurology." The vaccinee was seen for follow up by her family physician on 8/16/00. At this visit the vaccinee had been on doxycycline for one week and was "doing better about 40%. The tingling and numbness had decreased. Better when not at work." The vaccinee reported to the physician that she is "convinced she has lyme based on her feelings." The physician's impressions were "fatigue and malaise-pt referred to an infectious disease specialist and rheumatologist, MRI of brain revealed a questionable small lspot of no clinical concern, positive ANA." The vaccinee was seen by the infectious disease specialist on 8/18/00 (initial consultation). "vaccinee with history of reactive airway disease, allergies to dust, mites and molds. She has been sick for about two months but has had a worsening course over the last three months. She hikes with her dog in the state park, she has joint pain, muscle pain, tingling in her hands and feet, pain in her neck and pains in her hands and knees. She has decreased concentration. She has had some dry eyes and dry mouth and has had some abdominal pain over three weeks. She has been treated with doxycycline for one week and is not sure that it is helping. She is taking Xanax for sleep. She has a family history of allergy but no other diseases. She does not recall a specific tick bite but did have perhaps an atypical rash. Head and neck exam is normal. There are no real joint changes. Neurological exam is grossly intact. Lab exam includes MRI of the brain which is normal except for possible small abnormality next to the mastoid tip. An anti-DNA is negative. ANA is positive in a titer of 1:160 in an homogenous and speckled pattern. Thyroid testing is normal, x-ray shows mild narrowing in the lumbosacral joint. Lyme Western blot index is positive. Lyme EIA is negative. White count is 6.0 hemoglobin is 12 and platelets 207,000. Chemistries are normal. The pt has a history worrisome for Lyme disease but also worrisome for autoimmune disease with a positive ANA and dry eyes. Her hisotyr is a bit confusing. I will give her a month of doxycycline and recheck her labs, including the ruine antigen, Western blot, and the ANN. I am going to get a Schirmer's test, ES-A and SG-B looking for Sjogren's. I think she should be evaluated by neurology because of her specific symptoms and concerns. I will give her Clinpril for pain control and Flexeril to help her with sleep. The vaccinee was seen by a ear, throat and nose specialist on 9/16/00 for left ear pain. He noted that she "has Lyme disease." The vaccinee was seen for follow up by the infectious disease specialist on 10/5/00. The vaccinee was seen by her family physician on 11/21/00 following a motor vehicle accident on 11/18/00. At this visit the vaccinee was complaining of neck and low back pain. Family physician medical records noted that the vaccinee was given "tetanus" in Dec-00. Physical therapy consultation dated 1/16/01. The vaccinee was seen for follow up by the infectious disease specialist on 1/18/01. At this visit the vaccinee had been on oral doxycycline for about six months. She reported to the physician that she felt "well' and tha ther symptoms are entirely resolved and her only problem was a little bit of pain in her neck which had been present for some time. The vaccinee was seen for follow up by the infectious disease specialist on 2/8/01. The physician noted that the pt had been off doxycycline for about three weeks and that subsequently her symptoms recurred. The vaccinee reported to him that she had "increased pain in her hands and fingers, has been getting allergy shots and wonders if they may be associated. She has a bit of increased fatigue as well." The physician noted on physical examination that her "looks a bit down, head and neck exam normal, extremities revealed tender joints but no real swelling was noted." The vaccinee was discharged from physical therapy on 2/15/01. The physcial therapist noted that the "pt noted slight improvement in pain levels; however, fatigue noted in low back/Capne at end of day. Vacinee given a HEP of C/L flexability and strengthening. She noted slight improvement in functional activities with therapy; however, she did not follow through with therapy visits." The therapist also noted that physical therapy goals were not attained and that the pt made no progress. The vaccinee was again seen for follow-up with the infectious disease specialist on 3/8/01. Since she has discontinued the doxycycline, she has had episodes of significant fatigue, weakness, and worsening pain in her joints. On 3/9/01 HLA-DR and HLA-DQ phenotyping Lyme disease serology were performed a tthe order of a second rheumatologist. The results reported the detection of DR15, DR13, and DQ5 antigens. Western blots and serum were reported as equivocal. IgG bands 31 and 34 and IgM band 31 wre detected. PCR assayed serum revealed no "OspA gene." The vaccinee was seen by her family physician on 3/20/01. Vaccinee was seeking another referral for a rheumatologist for her Lyme disease. The rheumatologist faxed on 4/2/01 to the family physician handwritten notes; however, no date ws documented on these notes which appear to be the initial consultation. The vaccinee was seen by rheumatologist on 4/3/01 for a flare up with her joints. She reported that she had "burning lasting 1-2 days." The rheumatologist noted "bad arthritis.. long discussion about vaccine/autoimmune disease/long term consequences (unk)... assessment autoimmune disease from vaccine." The vaccinee was seen by the rheumatologist on 3/6/02. She reported that she was "feeling good, stopped taking medication x 2 weeks, said went ok until end of 7 day, getting all symptoms, burning, back on meds just two 1/2 weeks to build up to feel better." The adverse events of autoimmune arthritis and possible carpal tunnel syndrome do not meet serius criteria, but are being submitted as an expedited report by the special request per the 6/28/00 letter. Follow up 10/10/2002: "On 11/17/2000, the vaccinee returned to the neurologist for follow-up. He noted "no change" in review of systems and 'no deformities or edema' of extremities. Subjectively he noted; "Laboratory Date: Normal MRI, CBC, SMAI8. Positive Lyme titer. Western Blot negative. ANA 1-160, thyroid functions normal. Sedrate, RPR, serum protein electrophoresis normal.' His assessment was, 'Chronic fatigue syndrome.' His plan was: "1) At this point I have no further neurological recommendations. 2) The patient denies any muscle aching or pain or muscle weakness. I have asked her to continue following with...(infectious disease physician) for chronic Lyme. 3) If her weakness or fatigue increase, she will return to se eme. 4) The patient has recently started Zoloft and then she was feeling like she was becoming more depressed. I also advised her to return to...(other physician) if her depression increases." Y U 05/10/1999 07/01/1999 52 Lyme test X 2-neg; Lab test-arthritis; Thyroid test-neg; ANA-Very high; DNA-(+); MRI of brain-nml; AlanineTransminase, Serum: 9IU/L; Anti-DNA, double strand: Negative; Anti-DNA, double strand: Negative; Antinuclear antibody: 1:160positive; Antinuclear antibody: High; Antinuclear antibody: 1:320; Antinuclear antibody: 1:320; Band neutrophils (blood): 10IU/L; Complement C4, Serum: 14mg/dl; Complement C4, Serum: 18mg/dl; Complement C3, Serum: 109mg/dl; Complement C3, Serum: 108mg/dl; Erythrocyte Sedimentation Rate: 8mm/hr; Erythrocyte Sedimentation Rate: 4mm/hr; Human Chorionic Gonadotropin: Negative; RA Latix Turbid: 8.4IU/mL; White Blood Cell Count: 6.0x10-3/uL; White Blood Cell Count: 5.7Thous/mcL; The following tests and the results were reported by the vaccinee and/or her co-worker and as yet are not medically confirmed: May 2000: Unspecified test: "arthritis", Lyme Disease test: "negative", Thyroid test: "negative"; November 2000: MRI of brain: "normal"; February 2001: 'DNA' test: "positive"; however, Labs from 02/21/2001 indicated anti-DNA double strand was negative (please see medical record section below). The following tests and the results were found upon review of medical records: Lyme IgG and IgM Western Blot: Negative, Lyme AB Quant IgM: Negative (all bands absent), Lyme antibodies Western Blot Reflex 1.68: Positive >1.10, Lyme AB Interp: EIA Positive; Antinuclear Antibodies: Homogenous 1:160 and speckled pattern 1:160 (both positive if >=1:160). Spinal Imaging: Lumbar spine revealed mild narrowing at Z5-S1 disc space. Thoracic spine was unremarkable. Cervial spine was normal. MRI of Brain: Impression: No evidence of acute intracranial abnormality. Tiny focus of abnormal signal immediately inferior and anterior to the mastoid tip. This may represent a tiny nerve sheath tumor or conceivably a lateral small retropharyngeal lymph node. This finding is most likely of no clinical concern. Lyme Western blot: Lyme IgG WB Interpretation - Negative (all bands present). Lyme IgM WB Interpretation - Negative (all bands absent). Lyme antigen, PCR Urine - Negative. Antinuclear Antibodies: Homogeneous 1:320 and speckled pattern 1:320; Laboratory as reported by infectious disease specialist: ANA was positive at 1:320 in a speckled pattern and was homogeneous, and Lyme screen was positive. Lyme Westrn Blot Reflex: Lyme/Total Immunoglobulins - 2.36. Lyme Interpretation EIA - Positive. Lyme IgG WB Interpretation - Negative (Bands present: P30) (Bands absent: P93, P66, P58, P45, P41, P39, P28, P23, P18). Lyme IgM WB Interpretation negative (Bands absent: P41, P39, P23). Lyme Disease Ab, Quant, IgM - negative. Rheumatoid Arthritis Factor: RA Latex Turbid 8.4, Sedimentation rate 6, C4 Complement serum 18, C3 Complement Serum 108, ANA was 1:320 in a homogeneous pattern. Lyme Disease Western Blot: IgG equivocal, bands present 34,31; IgM equivocal, bands present 31, Lyme Disease DNA: PCR result, OspA gene - negative. HLA DR, DQ Phenotype: HLA-DR typing - normal, HLA-DQ typing - normal. Anti-nuclear AB w/AFX: ANA (HEP-2) - positive. ANA Titer & Pattern: Anti-nuclear AB titer and pattern: 1:80 diffuse. Anti-nuclear AB w/RFX: Anti-nuclear AB - positive. ANA Titer & Pattern: Anti-nuclear AB Titer: <1:40. PVT PVT Allergy medication, Loratadine, Azithromycin, Pseudoephedrine HCl, nasal (unspecified), methylprednisolone, Biaxin She is allergic to penicillin, has seasonal allergies and multiple other allergies (NOS). Concurrent medical conditions included asthma. She has a history of temporomandibular joint disease (onset 4/1/99), recurrent sinusitis (onset 1997), mild infection of right hand due to cat bite (12/17/98), bronchitis, vertigo, nausea, stomach upset, ear pain, chest and ear congestion, depression, heart palpitations, onset pressure and possible irritable bowel syndrome. She was in a motor vehicle accident on 11/18/00. 2001009075 1
0168631 04/12/2001 NY 35.0 F 04/10/2001 The pt experienced severe pain, swelling, redness at the site of injection 2 days post vax. A 7cm round area to the right deltoid was warm to the touch and swollen. The pt was treated with Benadryl, Motrin and Atarax. U 02/01/2001 02/03/2001 2 UNK UNK allergy to tetracycline, aspirin, cefaclor 1
0168632 04/12/2001 KY 1.75 1 .8 M 04/10/2001 The mother reported an apneic spell requiring stimulation. This happened twice. The pt experienced a hyporesponsive collapse. The pt is now on an apneic monitor and doing well with no further episodes and is scheduled to see a neurologist. Y Y 03/16/2001 03/23/2001 7 PVT PUB NONE stenosis 1
0168633 04/12/2001 IL 31.0 M 04/11/2001 The pt had profuse sweating, a heart rate of 140, BP 150/110, "saw white spots in eyes", arm felt numb, then heavy, some chest tightness, no shortness of breath. School nurse observed at 10:15 AM and called 911. Y Y 04/10/2001 04/10/2001 0 OTH OTH 1
0168634 04/12/2001 CO 47.0 46 M 04/04/2001 The pt experienced a mild onset of arthritis, psoriasis. It has been 3 years since the prior vax. Y 02/28/2001 03/01/2001 1 PVT UNK NONE 1
0168635 04/12/2001 KY 4.0 4 F 04/06/2001 The pt experienced a localized redness 2 1/2 inches around the injection site. There was a red halo around the site and white with middle with warmth to the touch. and a hardness at the injection site. Y 03/27/2001 OTH OTH NONE NONE NONE KY2001025 1
0168636 04/12/2001 TN 5.0 5 M 04/11/2001 The pt received the vaccine on 4/4/01 to the right thigh. the pt experienced a warm, red raised area that was 9 x 7 cm on 4/10/01. No pain, was seen in the office on 4/10/01. Y 04/04/2001 04/10/2001 6 NONE PVT PVT NONE NONE NONE 1
0168637 04/12/2001 WI 5.0 5 M 04/02/2001 The pt experienced a large local reaction that was 6 x 7 cm of redness and induration. Y U 03/30/2001 PVT UNK NONE NONE 1
0168638 04/12/2001 CA 27.0 27 M 04/02/2001 The pt experienced varicella disease 5 days post varicella vax. The pt had been exposed to the disease). Y Y 02/28/2001 03/05/2001 5 NONE PUB UNK NONE NONE 1
0168639 04/12/2001 WI 1.4 M 04/03/2001 The pt experienced total thigh swelling to 3 cm, fever and vomiting. Y NONE PVT PVT URI, rhinorrhea and cough NONE 1
0168640 04/12/2001 NY 11.0 11 M 04/06/2001 The pt developed a fever, headache and vomiting 24 hours post vax. He was ill for 2 days. Y 03/03/2001 03/04/2001 1 NONE PVT PVT NONE NONE allergy to eggs 1
0168641 04/12/2001 UT 7.0 1 .6 F 04/07/2001 The child was exposed to a friend who had chickenpox and then developed a fever and broke out with lesions the next day. Has 20+ lesions at present. Y U 09/13/1995 04/05/2001 2031 NONE PVT PVT NONE probable croup NONE 1
0168642 04/12/2001 NY 26.0 26 F 03/28/2001 The pt received the varicella vaccine on 2/1/01. One week later developed hives on wrist, arms and back. Resolved after a couple of days. No further complaints. U 02/01/2001 02/08/2001 7 UNK UNK 1
0168644 04/13/2001 FL 0.4 0 .4 F 04/09/2001 "A territory representative reported that a 5 month old female received her 2nd dose of Prevnar along with Hib-Titer, DTAP and IPV vaccines on 2/7/01. On 3/16/01, the infant developed "acute" meningitis. The following day, she was hospitalized. An unspecified culture was positive for Streptococcus pneumonia, serotype unknown. The infant was treated with Ampicillin and Rocephin (ceftriaxone)." Also diagnosed with anemia. Y U 02/07/2001 03/16/2001 37 Unknown serotype-positive for Streptococcus pneumonia; CT scan-neg PVT PVT Vitamins NONE UNK U2001006120 1
0168646 04/13/2001 GA 2.5 1 .0 F 10/02/2002 A physician reported that a 12 month old female received an injection of Hib-Titer on 12/23/98. On 7/9/00, at the age of 31 months, the child was dx'd with meningitis and septicemia. She was hospitalized and treated with unspecified antibiotics. The child recovered and was discharged on 9/17/00. *Follow-up report on 10/7/02: A report from manufacturer "An MD reported that a 12-mt-old received an injection of Hib-Titer on 12/23/98. On 7/9/00 at the age of 31 mts, the child was diagnosed w/meningitis and septicemia. She was hospitalized and treated w/unspecified antibiotics. The child recovered and was discharged on 7/17/00." From follow-up faxed correspondence received on 7/16/01 it was reported that a KUB(?) was ordered which was normal. The upper GI was done and showed narrowing of the 2nd portion of the duodenum. A barium enema was also done which was also negative. Alylase and lipase were drawn which were both w/in normal limits. Blood culture had grown gram negative bacilli. Due to worsening clinical condition and growth of gram-negative hecilli from blood culture, the PT was started on ampicillin and gentamicin. The PT had a lumbar puncture done w/Gram stain showed rare gram-negative bacilli and many PMNs w/white blood cell count of 871 w/61 segs, 25 bands, 1 lymph, 13 monos, 663 red blood cells, 118 CF protein and 27 glucose. As a result, PT was thought to have H flu type B meningitis. The PT was continued on ampicillin and gentamicin and restarted on Recephin. Ampicillin and gentamicin were discontinued and PT was kept on Rocephin 1.2 gm every 24 hrs for 10 days. A CT of the sinus was done on July 11th, which showed chronic disease of the ethmoids and maxillary sinuses. The sinuses were considered to be the source of the infection. The IgG level was found to be deceased at 320, IgF level was 119, C3 level was 133, blood cultures grew back H flu type H, CSF cultures for bacteria had no growth to date. On 7/17, the PT was almost back to baseline was considered ready to be discharged. Principle diagnosis: H flu meningitis - chronic, chronic sinusitis. Follow up #2 received on 9/19/02 from literature report: The PT is a 30 mt old, previously healthy female child who presented to the Emergency Dept w/the acute onset of fever to 102 deg F that evening. Her mother noted some mild, clear rhinorrhea and sneezing for several days. Shortly after the onset of fever, she vomitted several times and complained of some headache. As the evening progressed, her appetite and fluid intake declined. The PT received a completed primary series of vaccinations at the local health dept w/out adverse reactions. She received a tetanus toxoid conjugated Hib vaccine at 2 mts of age and a diphtheria cross-reacting material protein conjugate at 4, 6 and 12 mts. She did not receive conjugate pneumococcal or rotavirus vaccines. The child seemed weak, febrile to 39.4 deg C, and tachycardic to 150 beats/min w/a stable blood pressure of 106/54 mm Hg. She weighed 12 kg (25th percentile). Head and neck exam was notable for dull tympanic membranes and clear rhinorrhea. Mucous membranes were dry. There was no nuchal rigidity or cervican edenopathy. Lungs were clear. Cardiovascular exam revealed tachycardia w/a 2/6 systolic murmur at the left, upper sternal border and good peripheral pulses and perfusion. Abdomen was soft, nontender, and nondistended w/out organomegaly nor peritoneal signs. Multiple small pustules were noted on the inner thighs, but no other rash was apparent. Neurologically, the child was normal and responsive to commands. Complete blood cell count showed a white cell count of 2.200/mL w/33% neutrophilo. 13% bands, 50% lymphocytes, 3% metamyelocytes, and 1% atypical lymphocytes. The hemoglobin was 13.0 g/dL w/a hematocrit of 38.5%. Platelet count was 200,000/mL. A basic metabolic profile was notable for potassium of 3.2 mEq/L and blood urea nitrogen of 13 mg/dL. Urinalysis was unremarkable. Blood and urine cultures were obtained. In the Emergency Dept, the PT received intravenous fluids and 500 mg ceftriaxone. Although more active after hydration, she continued to vomit and was admitted. W/in 12 hrs, she became more lethargic, developed meningeal signs, and was transferred to the pediatric intensive care unit. Her initial blood culture grew pleomorphic Gram-negative coccobacilli. Lumbar puncture yielded slightly hary cerebrospinal fluid with glucose of 27 mg/dL (normal 45 to 75 mg/dL), protein of 118 mg/dL (normal 14 - 45 mg/dL0, 653 REC/mL, and 871 WBC/mL. The microbiology lab later identified Hemophilus influenza type b (Hib) from the blood culture. Cerebrospinal fluid culture was sterile, but latex agglutination to Hib was positive. Lab evaluation revealed normal IgA, IgM, and IgE levels. Total IgG was low-normal w/depressed IgG and IgG4 levels. Although C3 and C4 levels were normal, the PT's CH50 was below the level of detection on 2 occasions. This case is closed. Y 70 Y 12/23/1998 07/09/2002 1294 White blood cell count 2.2 H&H 13 and 38.5, Platelets 200, 33 segs, 13 bands, 50 lymphs, SMA-7 was normal. PHYSICAL EXAM: *Temperature to 39.4 deg C, *Techycardic to 150 beats/min, *Stable blood pressure of 106/54 mm Hg, *Weighed 12 kg (25th percentile), *Head and neck exam was notable for dull tympanic membranes and clear rhinorrhea, *Mucous membranes were dry, *There was no nuchal rigidity or cervical adenopathy, *Lungs were clear, *Cardiovascular exam revealed tachycardia w/a 2/6 systolic murmur at the left, upper sternal border and good peripheral pulses and perfusion, *Abdomen was soft, nontender, and nondistended w/out organomegaly nor peritoneal signs, *Multiple small pustules were noted on the inner thighs, but no other rash was apparent, *Neurologically, the child was normal and responsive to commands. LABORATORY: *Complete blood cell count showed a white cell count of 2,200/mL w/33% neutrophilo, 13% bands, 50% lymphocytes, 3% metamyelocytes, and 1% atypical lymphocytes; *The hemoglobin was 13.0 g/dL w/a hematocrit of 38.5%. Platelet count was 200,000/mL; *A basic metabolic profile was notable for potassium of 3.2 mEq/L and blood urea nitrogen of 13 mg/dL; *Urinalysis was unremarkable. Blood and urine cultures were obtained; *Initial blood culture grew pleomorphic Gram-negative coccobacilli; *Lumbar puncture yielded slightly hary cerebrospinal fluid with glucose of 27 mg/dL (normal 45 to 75 mg/dL), Protein of 118 mg/dL (normal 14 - 45 mg/dL), 653 KBC/mL, and 871 WBC/mL; *The microbiology lab later identified Hemophilus influenze type B (Hib) from the blood culture; *Cerebrospinal fluid culture was sterile, but latex agglutination to Hib was positive; *IgA, IgM, and IgE levels were normal; *Total IgG was low-normal w/depressed IgG and IgG4 levels; *Although C3 and C4 levels were normal, the CH50 was below the level of detection on 2 occasions. OTH OTH NONE History of ear infections, Narrowed portion of the duodenum, chronic sinusitis. U200100614 1
0168647 04/13/2001 PA M 04/11/2001 A patient's aunt reported that her nephew received three separate doses of Acel-Imune and Hib-Titer and possibly one dose of Rota Shield between December, 1998 and April, 1999 and developed autism. As of 04/05/01, no further info was available. MANUFACTURER"S COMMENT: The lot number for the first dose of Hib-Titer was reported as 48020; however, this is not a valid Lederle lot number. The reporter also indicated that the lot number for Rota shield was M235RA: however, this is not a valid Wyeth lot number. This lot number (M235RA) is a valid Lederle lot number. Y N UNK OTH OTH UNK UNK UNK HQ9444409APR2001 1
0168648 04/13/2001 NJ 0.3 0 .3 M 04/05/2001 About 20 hours after receiving immunizations, at about 8:30 AM; at home the baby started tonic / clonic movements lasting about 25 minutes according to family. the eyes staring and unresponsive. At the ER 3 hours later the events reappear. Follow-up received on 4/26/01 states that the baby has died. Y 04/16/2001 Y Y N 04/04/2001 04/05/2001 1 CT scan of head in ER on 4/5/01-hydrocephalus; labs-Na-128; K-5.2; CR-99; C02-21; Bun-40; CR-1.1; Gluc-90; Ca-8.8 Left kidney-dystrophic calcification; right kidney-focal acute inflammation; right adrenal-dystrophic calcificaton; right lung-congestion and focal aspiration; left lung-congestion; thymus-dystrophic calcification PVT PUB Tylenol Increased tone; developmental delay; bilateral dilated frontal horns 1
0168649 04/13/2001 TX 0.2 0 .1 F 04/09/2001 "A physician reported that her 2 month old daughter received her 1st dose of Prevnar, Comvax, IPV and DTAP vaccines in 1/01. On 2/20/01, she was treated and released from the ER for a seizure and high fever. As of 2/22/01, she continued to receive treatment with ceftriaxone. Seizures are considered "Medically Important". F/U was rec'd from a HCP. She was treated at the ER with ceftriaxone sodium (Rocephin). Lab work was done, a LP was offered but was refused by the parents. The pt was discharged form the ER. On 2/21/01 the pt was seen for follow up in the pediatrician's office. She was given ceftriaxone sodium (Rocephin) 700mg again. On 2/22/01 the pt was in the physician's office for another follow up visit, and it was documented that the pt was alert, active, and doing great. The blood cultures were normal with no growth. The pt's ears were red, and the final dx was a urinary tract infection. The last visit for the pt was 3/14/01, at which time she rec'd her second dose of haemophilus B conjugate vaccine(+) hepatitis B vaccine recombinant (yeast). The decision was made to not give the pt a second dose of Streptococcus pneumonia vaccine (Prevnar). F/U correspondence rec'g on 8/29/01 pt's lab data was provided. Very high fever. Y U 01/01/2001 02/10/2001 40 UNK F/U CBC and blood cultures were performed,cultures were normal, the CBC came back with elevated WBC's PVT OTH NONE UNK U2001006150 1
0168650 04/13/2001 TX 1.5 1 .3 M Within 3 minutes of vaccines given, both injection sites broke out with rash. Mom got Benadryl and 1/2 tsp po. Rash continued mainly around front of neck and down with smaller amounts to stomach, back, arms and lower legs. Rash was blotchy. Has never reacted to injections before this. At 18:25, rechecked and rash is clearing up. Only rash noted at this time is at injection site and it's fading. Family left at 18:45. No further problems. On 2/21/01, at 07:41 called and parent stated no rash or problems throughout the night. Continued to give Motrin and Benadryl every 4 hours. States only marks on child is where shots were given. States has knot at one injection site on (RL). (To be expected from DTAP vaccine). Y 02/20/2001 02/20/2001 0 PUB PUB Allergy to PCN TX01018 1
0168651 04/13/2001 CA 1.25 1 .3 F 04/06/2001 Pt with tonic/clonic seizure X 4 minutes at home within 1-2 days of immunization, self resolved. Evaluated in ER and looked well. Y Y 03/28/2001 03/29/2001 1 EEG; Blood test PVT UNK NONE NONE 1
0168652 04/13/2001 WI 3.0 3 F 04/06/2001 Fever, anorexia and pain at injection site on left thigh. Left thigh has a 3-4cm area of erythema, induration and increased heat of overlying skin. No evidence of infection. Vaccine reaction. Recommend that Prevnar vaccine not be repeated in this pt. On 4/2/01, 09:45, pt has vomiting and diarrhea, no fever per parent. Will give Pedialyte, Gatorade, 7-up, jello, popcicle in small amounts, Tylenol/ibuprofen if fever. Call if symptoms persist. Injection site has redness. Y U 03/29/2001 03/30/2001 1 BP 92/60 PVT UNK NONE Nasal congestion NONE 1
0168653 04/13/2001 MA 0.2 0 .2 M 04/06/2001 Post vax, 2 month old male, became fussy and cranky and not himself. Advised to continue on Tylenol. T-98.7 U 04/04/2001 04/05/2001 1 PVT PUB NONE NONE NONE 1
0168654 04/13/2001 MO 2.0 2 .1 F 04/09/2001 Large urticarial rash on site of injection within 2-4 hours, post vax. Given Benadryl po and resolved rash within 2 days. Y Y 04/05/2001 04/05/2001 0 NONE PVT PUB NONE NONE NONE 1
0168655 04/13/2001 TX 0.25 0 .3 F 01/29/2001 Skin rash all over body, temperature 100.5F and was fussy. Y 01/26/2001 01/26/2001 0 PVT OTH TX01012 1
0168656 04/13/2001 TX 3.0 3 F 02/27/2001 Child received Hep-A #2 and Pneumococcal conjugate. Had no reaction to Hep-A #1. Injection site clear; no redness or swelling noted. Small rash on face (cheeks) and on arms. Rash was mild; no hives noted; child playing. No itching noted. Treated with Benadryl po. Y 02/27/2001 02/27/2001 0 PUB PUB TX01026 1
0168657 04/13/2001 TX 0.3 0 .3 M Temperature to 104F, 6-12 hours, post vax. Y Y 02/02/2001 02/03/2001 1 CBC; Blood culture and urine cultures-all neg PVT PUB NONE NONE NONE TX01014 1
0168658 04/13/2001 TX 4.0 4 M 02/08/2001 Left thigh was swollen, red and warm to touch. Had no other symptoms. Child's mother states when he woke up the morning of 2/1/01, his left thigh was red and swollen. Referred to MD and they instructed mother to put an ice pack to his thigh. I did a follow-up call on 2/5/01 and mother states child's symptoms went away on 2/3/01 and he is fine. Y Y 01/30/2001 02/01/2001 2 NONE PUB PUB NONE NONE NONE TX01016 1
0168659 04/13/2001 TX 4.0 4 M 03/02/2001 Redness, swelling, pain, itching and induration of approx. 4" X 4" to injection site w/c is the left lateral thigh. Area also feels hot. Follow-up call on 3/6/01, pt recovered. Y 02/28/2001 02/28/2001 0 PUB PUB NONE NONE NONE TX01027 1
0168660 04/13/2001 TX 2.0 2 .1 M Left thigh swollen and raised around site with rash to back and abdomen. Y 03/07/2001 03/09/2001 2 NONE PVT PUB Cough, runny nose NONE TX01031 1
0168661 04/13/2001 TX 2.0 1 1 M 03/20/2001 Few hours, post vax, pt developed fever, irritability and wheezing. Treated at home with antipyretics and albuterol nebs. Fever stopped, 4 days, post vax, but wheezing continued. Y 03/13/2001 03/13/2001 0 PUB PUB Albuterol as needed NONE RAD TX01032 1
0168662 04/13/2001 TX 1.25 1 .3 F 03/28/2001 Redness, swelling to proximal lower extremity; resolved in 48 hours. Y 03/22/2001 PVT PUB Allergy to milk products; GERD TX01036 1
0168663 04/13/2001 TX 0.2 0 .2 F 01/29/2001 The evening of receiving vax, the pt experienced a decreased appetite. Pt was awake every three hours all night and experienced several episodes of spitting up the next morning. About 1PM the day after receiving vax, the pt developed a high pitched cry that worsened throughout the afternoon. Pt was seen in ER by 8PM. Pt was treated with Motrin. Y Y 01/23/2001 01/23/2001 0 PVT PVT NONE Constipation 1
0168665 04/13/2001 NJ 37.0 36 F Neck pain, joint pain in knees, re-infection of a prior viral infection, constant recurring herpes simplex type 1, paresthesia, burning, tingling, numbness, fatigue and chills. Called to state that she was tested for HLA-DR4 and was positive. She is not certain yet if her condition is permanent and will be consulting with a rheumatologist in the near future. N 04/08/1999 06/08/1999 61 PVT PVT NONE NONE 1
0168666 04/13/2001 NY 35.0 F 04/10/2001 Pt had severe pain, swelling and redness at injection site, 2 days, post vax. Had 7cm round area of right deltoid and was warm to touch and swollen. Treated with Benadryl po, Atarax po and Motrin po. Y U 02/01/2001 02/03/2001 2 UNK UNK Allergies to tetracycline/aspirin/cefaclor. 1
0168667 04/13/2001 TX 48.0 48 F 01/31/2001 On 1/26/01, approx 10:00, throat started hurting, coughing and head hurting. On 1/27/01, states she had a fever but does not know how much. On 1/28/01, states she had a fever, chest and back was hurting she went to ER but she was not told how much fever. In ER, she had blood work x-rays done. ER doctor told her results were all ok. Told her probably virus and to go home and to recheck with her doctor in the morning. On 1/29/01, she went to MD and he told her it could be attributed to flu shot. Gave A/B for 3 weeks and gave shot and told her more like sinus infection. Please note that she has had the flu shot in previous years with no reaction. Y U 01/25/2001 01/26/2001 1 ? blood work and x-ray. Stated ER told her everything ok and was possibly a virus. PUB PUB Known to have sinus and allergy problems. TX01010 1
0168668 04/13/2001 PA 7.0 12 F Rash (red papules and ruptured blisters with red base) all over the body. Y U 07/24/1995 UNK UNK 1
0168669 04/13/2001 OK 41.0 41 F 03/23/2001 7 days, post vax, pt had rash with itching (urticaria) on left upper arm below injection site that did progress to injection site. The following morning, urticaria developed bilaterally from distal lower leg to plantar surface of feet. Decrease in rash on left upper arm today. Y U 03/14/2001 03/21/2001 7 NONE PUB PUB One Source Multivitamin; FESO4 daily; PPD/Aventis/C0256AA/ID/0 previously NONE OK0112 1
0168670 04/13/2001 OK 34.0 44 M 02/07/2001 Onset maculopapular rash on trunk, extremities and spreading down arm. Pruritic. No fever, URI symptoms or new exposure. Y Y 02/05/2001 02/06/2001 1 NONE PUB UNK NONE NONE OK0108 1
0168671 04/13/2001 OH 22.0 22 F 04/09/2001 Gradual onset of hives starting morning after vaccines. Pt complained also of mild respiratory discomfort relieved with Benadryl. Pt presents to clinic with complaint of urticaria with pruritus. No history of previous reaction. No known other allergies. No current medications. Y 04/05/2001 04/06/2001 1 NONE OTH PVT NONE NONE NONE 1
0168672 04/13/2001 OH 5.0 5 F 04/09/2001 On 4/5/01, woke in the AM with pain in cheek and behind ear, throat edema, pinpoint rash on body, temperature 100.6F and symptoms lasted until 4/7/01. Seen per doctor and treated with Augmentin bid. Y 03/20/2001 04/05/2001 16 PUB UNK 1
0168673 04/13/2001 IL 10.0 10 F 03/29/2001 Vaccine given on 2/28/01. Rash started on 3/2/01 on thigh to elbow to shoulder to face. Rash hurts. No itching. Calamine lotion used. On 3/24/01, saw doctor. Feet cramps every night for 2 weeks. Doctor gave pt cream to apply to rash. Mother couldn't remember the name of the cream. U 02/28/2001 03/02/2001 2 NONE PUB PUB NONE NONE Allergy to bees; metal sensitivity and detergents. 1
0168674 04/13/2001 IL 10.0 9 F 04/03/2001 Within minutes of receiving her Hep-B #2 vaccine, the pt fainted and as she was lowered to the floor, her body jerked X 1. (She did not fall). She regained consciousness within a minute. When she went into the hall for fresh air, mom states that she fainted again. Mom concerned that she had a seizure. Paramedics were called and they examined her but found no problems. Mom took child to physician but he also found no problems. On Saturday, 3/31/01, the child got hives on her cheeks, neck and back of legs. Friday, she had worn new outfit (running suit). Mom unsure if hives from shot or something else. Y Y 03/15/2001 03/15/2001 0 NONE PUB PUB NONE NONE Mom states child gets "hives" "easily". Briefly pale, nausea but ok when she gets fresh air.~Hep B (Engerix-B)~1~9.00~In Patient IL01008 1
0168676 04/13/2001 CA 32.0 32 F 04/02/2001 Pt came to clinic to consult of her reaction to varicella vaccine. She has 3" X 4" size redness, swelling and pain on left upper arm. Claims size of redness is smaller today. Applied Caladryl for itching and relief. Advised cold compresses, cortisone cream to site and observe for severity of symptoms. Y 03/30/2001 04/01/2001 2 NONE PUB PUB NONE NONE CA010027 1
0168677 04/13/2001 CA 4.0 4 M 04/04/2001 Erythema, induration of right upper arm and extending to shoulder. Pt with cervical adenopathy and eosinophilia. U 04/02/2001 04/03/2001 1 WBC-48,600; 68, N 14 & 14 m 8 eos 60 H/H 12.6/35.8 PVT PVT PPD/Connaught/C0151AA/ID/RFA/1 previous NONE 1
0168678 04/13/2001 IL 1.1 1 .1 M 04/08/2001 7 days, post vax, pt came down with a fever for 3 days. On the 4th day he broke out in small red bumps all over his body for about 5 days. Y 03/11/2001 03/18/2001 7 PUB UNK NONE Allergy to milk, eggs and cats. 1
0168679 04/13/2001 MA 4.0 4 F 04/05/2001 Mom called 48 hours, post vax and described reddish brown bruise under DTAP injection site, "looks like she was hit with a baseball"; hard and warm to the touch. Recommended Tylenol or Motrin for discomfort, ice and to monitor area. Call if fever develops or if swelling increases further. N 04/03/2001 04/05/2001 2 PVT PUB 1
0168680 04/13/2001 TX 35.0 35 F 04/02/2001 On 4/26/00, I received my 1st pre-exposure rabies shot. The next day, I started getting a headache that would not go away. On 4/30/00, I became very sick; headache, nausea and vomiting, dizziness and disorientation. At about 21:00, I went to the ER and they treated me for migraine headache with a shot and pills. On 5/3/00, I had my 2nd rabies shot. I still had the headache all of this time and on 5/5/00 at about 11:45, I got ver nauseated, disoriented, my glands became swollen, became either cold or hot to the touch, neck pain, tingling in hands and feet. I went to doctor and was given a prescription of promethazine 25 ml to help with nausea, but it took more than 24 hours to get out of my symptoms. I stayed out of work until 5/10/00. On 5/8/00, all of the same symptoms re-accrued. I stayed with a friend of mine who is a nurse so that she could keep an eye on me. I went back to doctor on 5/10/00, for blood testing. Y Y 05/03/2000 05/05/2000 2 Blood tests done on 5/10/00 PUB PVT Effexor XR 75mg daily; Lorazepam 2mg HS NONE NONE TX01039 1
0168681 04/13/2001 TX 12.0 12 F 01/22/2001 On 1/19/01, complained of hives, progressing from 1 to many over body, neck, thighs and left breast. Treated with Atarax. On 1/22/01, complained of temperature of 103F and still has hives. Complained of sore throat and was referred to MD. Z-pak/cough syrup. On 1/23/01, temperature increased and still has hives and are leaving scars. Went to ER X 3. Y Y 01/17/2001 01/19/2001 2 PUB PUB NONE NONE Environmental allergies; possible PPD-10/81-treated 18 months with INH TX01009 1
0168682 04/13/2001 TX 11.0 11 M 01/22/2001 Hives, increased temperature; went to ER X 2. On 8/16/00 and 9/20/00; seen by physician and ER. Missed 8 days of school. Exemption from MD for Hep-B #3. Adverse reaction to Hep-B. Y Y 09/20/2000 09/20/2000 0 UNK PUB PUB UNK UNK TX01008 1
0168683 04/13/2001 TX 11.0 11 M 01/29/2001 Rash started on 1/24/01. Complained of being hot (temperature not taken), stomach ache. Many allergies. Rash getting worse. Started out dry but now "bumpy red" and itching. Slight rash but cleared after 2nd Hep-B on 1/29/01. Seen by MD who dx'd child with shingles. Y U 01/23/2001 01/29/2001 6 PUB PUB NONE Allergies to milk, bees, ants, bananas and some laundry TX01011 1
0168684 04/13/2001 TX 50.0 49 F 02/07/2001 3 days, post vax, had fluid filled blisters that appeared at site of injection. Afterwards, fluid filled blisters appeared on hands and feet for 3-4 days. Afebrile. Referred to local ER on 1/28/01. Y U 01/24/2001 01/28/2001 4 PUB PUB NONE NONE NONE TX01013 1
0168685 04/13/2001 TX 0.86 0 .9 M 01/31/2001 Clinic called to report pt was taken to ER and was diagnosed with generalized urticaria post vaccine. Was treated with Benadryl 10.9 mg PO now and q 4-6 hrs prn hives. Pt to follow up per Dr. Y U 01/30/2001 01/30/2001 0 OTH OTH none none none TX01015 1
0168686 04/13/2001 TX 11.0 11 U Mild cellulitis L deltoid. U 02/13/2001 02/14/2001 1 PVT PUB none TX01016 1
0168687 04/13/2001 TX 8.0 8 M 10/30/2000 Fine raised, red rash under left arm and around left upper chest and left arm pain. Small petechiae down both extremities with welt-like appearance. Red papular area with excoriation noted on the sacral area 3cm. Papular red scaley area noted behind left ear. Observed child scratching areas. Mother has been applying Calamine lotion and reports no temperature or changes in eating habits. Y U 10/20/2000 PUB UNK TX01017 1
0168688 04/13/2001 AR 48.0 48 F 02/26/2001 The pt received TD booster on 2/14/01. Complained of soreness at the injection site on 2/15/01. She stated that she took Advil for discomfort. On 2/17/01, whelps were noted on left arm around the elbow. The pt denied other rash / difficulty breathing / elevated temp. The pt continued Advil. Symptoms resolved on 2/22/01. Y 02/14/2001 02/17/2001 3 NONE PUB PUB Advil, hormones, quinine NONE allergy to codeine TX01019 1
0168689 04/13/2001 TX 11.0 11 M The pt's mother reported his left arm was red and swollen and "his left leg hurts". The pt was referred to a physician for evaluation. Stated there was no problem with his leg and the arm was just a local reaction and no treatment was required. Y 02/21/2001 02/22/2001 1 PUB PUB NONE NONE NONE TX01020 1
0168690 04/13/2001 TX 36.0 36 F 03/06/2001 Patient complained that injection hurt slightly at time of administration. By 2 hours later, having pain radiating down left arm and back. Arm swollen with localized warmth. Hurt so much that didn't sleep for 3 nights. Also had headache. Went to clinic on 3/2/01, Darvoset prescribed. Has improved but still having pain in arm. Y 02/28/2001 02/28/2001 0 NONE PUB PVT NONE NONE NONE ~Measles + Mumps + Rubella (no brand name)~2~0.00~In Patient TX021 1
0168691 04/13/2001 TX 12.0 12 F 02/16/2001 This patient had a rash that began on the right forearm, then appeared on the right side of her face, on her ear, and behind both ears. She left school at approximately 2 PM. The mother called the doctor / ER and they said to give her Benadryl every 4 hours. It was a itchy rash on the forearm like mosquito bites; face had a poison ivy type rash; ears had a rash like poison ivy too. The patient got better with the Benadryl but without it, it comes back. Y 02/14/2001 02/15/2001 1 PUB PUB NONE NONE TX01022 1
0168692 04/13/2001 TX 11.0 11 F 02/24/2001 This child was sitting in the lobby on the bench after about 5 minutes of receiving the Hep B, MMR, and PPD; when without provocation the child hyperextended back to neck. Dropping on the bench. Seconds later she was less rigid, she was asked to sit but she was still lethargic. 911 was called, the mother ran to find the father who is an RN assistant. The child totally recovered in 5 minutes. No illnesses were reported, the mother and father said she is a healthy child. Y 02/24/2001 02/24/2001 0 PUB PUB PPD, Connaught, Lot # C0046AA, left arm. NONE NONE TX01023 1
0168693 04/13/2001 TX 37.0 37 F 02/23/2001 This patient had severe joint pain, fever of 102 - 103, nausea, vomiting, and pulse of 120. Treated with Advil, Tylenol, Tamiflu, and Augmentin. Y 02/16/2001 02/16/2001 0 CBC - WBC's 15,600 (rest normal). TFT - Nml. OTH OTH NONE NONE TX01024 1
0168694 04/13/2001 TX 1.08 1 .1 F 02/22/2001 This infant had a macular rash, varible sizes, and fever of 103. To ER vital signs done. Tylenol rectally to continue. The rash subsided 03/01/01. N 02/12/2001 02/22/2001 10 NONE PUB PUB NONE NONE Allergic to Penicillin, and Erythromycin. TX01025 1
0168695 04/13/2001 TX 4.0 4 F 03/02/2001 This child received DTaP and IPV on the left upper arm and MMR and Hep A on the right upper arm. Her left upper arm is red, warm to touch and swollen since 03/01/01, vaccines given on 02/28/01. No fever. Full range of motion of arms both right and left. Patient sent to ER today 03/02/01. Y 02/28/2001 02/28/2001 0 Results pending. PUB PUB Tylenol TX01028 1
0168696 04/13/2001 TX 8.0 8 F 2 days after immunization, this patient went to the center for redness and swelling to varicella site on the right arm. The patient was seen by a doctor and told to keep the area clean and dry, and use over the counter Tylenol return if necessary. Y 02/13/2001 02/15/2001 2 NONE PUB UNK TX01030 1
0168697 04/13/2001 TX 50.0 51 F 03/26/2001 50 year old female with an onset of chills, fever, body aches on 3/23/01 at 8:30am. The pt stated a local reaction to left arm from deltoid to elbow with redness, swelling and pain to left arm radiating down to axillary lasting two days. The pt also experienced itching to the site. U 03/22/2001 03/23/2001 1 PUB UNK NONE hx of hypertension TX01033 1
0168698 04/13/2001 TX 4.0 4 F 03/26/2001 The mother described a "knot as big as a goose egg" on the right leg on 3/21/01. Saw the doctor on 3/22/01. Redness that was 4x5cm, knot 3x4cm, mild cellulitis, right leg noted. Treated with Keflex. On 3/26/01 redness is resolved and knot reduced to 2x2cm. Y Y 03/20/2001 03/21/2001 1 NONE PUB PUB NONE TX01034 1
0168699 04/13/2001 TX 4.0 4 M 03/16/2001 The pt received the vaccines and then experienced swelling from the elbow to the shoulder on the left arm. The pt has 7 blisters in the area of swelling. Arm is tender to the touch. Blistering started on 3/15/01 and swelling the same day of vaccines. Instructed to see PMD for treatment. Treated with warm compresses, oral antibiotics (cephalaxin) and silvadine cream. Arm swelling and redness have decreased. Has good ROM in arm. Y Y 03/14/2001 03/15/2001 1 PUB PUB Tylenol hemophilia hemophilia (dx at birth) TX01035 1
0168700 04/13/2001 TX 14.0 14 M 03/23/2001 At 11:06am the pt vomited and became pale, diaphoretic, dizzy. Placed head between knees. Pulse was 72. The pt was moved to a table to lie down. At 11:08am BP was 86/48, pulse was 72 the pt was still pale, dizzy but responsive. At 11:10am, BP was 104/60, pulse 72, color is better, stated feeling better. At 11:15, the pt sat up, became pale and dizzy, laid back down. Pulse was 76. At 11:30am. BP 110/60, pulse 80. Color is now normal and when she sat up was ok. At 11:40 the pt walked to waiting area. After a 3:00pm phone call home. All is well. Y 03/23/2001 03/23/2001 0 PUB PUB Risperdal, Ritalin, Trazodone ADD TX01037 1
0168701 04/13/2001 TX 45.0 45 F 03/01/2001 Following vax, the pt developed a pustule at the site of the injection. The next day a knot developed about 2 cm below the injection site and it was red and warm to the touch. The pt experienced tenderness around the knot and under the left arm. The pt denies a fever. The pt took Tylenol and was using warm packs at site on arm. U 02/27/2001 02/28/2001 1 PUB PUB Premarin, Tenormin sinus infection TX01038 1
0168702 04/13/2001 TX 52.0 52 M 02/22/2001 The pt experienced urticaria 2 weeks post vax. Has had chronic urticaria since then. N 07/19/2000 CBC, Diff, ESR, RAST PVT PVT NONE 1
0168643 04/16/2001 IN 0.6 0 .6 M 04/09/2001 It was reported that a male patient received an IPOL, a Hibtiter, a Hepatitis B, and an Acel-Imune vaccination on 04/04/01. Reportedly two days after vaccinations the patient expired. The patient was put down for a nap, The patient's mother went to check on him, the patient wasn't breathing; she called 911. Cause of death SIDS. Y 04/06/2001 N 04/04/2001 04/06/2001 2 PVT PVT Amoxil None-- hd just recovered from BOM hospitalization 3/10/01 to 3/11/01 for RSV U2001006110 1
0168703 04/16/2001 MI 1.08 1 .1 F 04/12/2001 A physician reported that a 13 month old female received Prevnar, MMR, and Hep-B vaccines on 4/2/01. On the night of 4/4/01, she developed a fever of 104F. On 4/5/01, she was seen by the physician who noted a fever of 103.4F. She was hospitalized. A blood culture was positive for streptococcus pneumonia. She was treated with unspecified antibiotics and discharged after 4 days. The physician stated that the child has "chronic diarrhea". Follow-up received from the physician on 5/8/00, indicated that the child was treated with ampicillin for 5 days. She recovered. Y Y 4 Y 04/02/2001 04/04/2001 2 Blood culture positive - for Streptococcus pneumoniae PVT OTH NONE UNK Diarrhea NOS HQ9582611APR2001 1
0168704 04/16/2001 MA 2.0 U 04/11/2001 A 2 year old child received an injection of Prevnar in March, 2001. Forty-eight hours post-immunization, the child developed a fever and swollen lips. A diagnosis of herpes simplex virus gingivostomatitis was made; however the child's symptoms resolved within 36 hours. The child was well for approximately 1 or 2 days, then presented with swollen lips, red oral pharynx, palmar erythema and swelling, and fever then was hospitalized. The child had a positive throat culture for a group A streptococcus. The differential diagnoses on admission were atypical Kawasaki syndrome, group A Streptococcus syndrome, or reaction to Prevnar. The reporter noted that the child's older sibling had a recent history of a streptococcal throat infection. Y U 03/01/2001 03/03/2001 2 Throat culture-positive for group A Streptococcus OTH OTH UNK UNK UNK HQ9352105APR2001 1
0168705 04/16/2001 NY 60.0 60 M 04/05/2001 Three days post vax, the pt developed severe sharp needle like prick pain in deltoid at the site of injection and deep aching pain in the left shoulder followed by prickling numbness in left arm, forearm and hand. Y U 03/11/2001 03/13/2001 2 PVT UNK laceration of lower lip NONE 1
0168706 04/16/2001 NY 0.5 0 .6 F 04/10/2001 6 hours post vax, the pt had a episode in which she closed her eyes, tensed her hands and stiffened arms. No unresponsiveness, no color change, no limpness. Pt experienced 3-4 similar episodes and was seen in the office. Y Y 04/07/2001 04/07/2001 0 NONE PVT PVT NONE NONE 1
0168707 04/16/2001 WI 0.2 0 .2 F 04/06/2001 Within 24 hours post vax, the pt developed a high pitched cry fore a duration of 4 hours. No fever present, no redness or swelling, and no evidence of site involvement. Pt treated with acetaminophen. N 04/05/2001 04/05/2001 0 NONE PVT PUB NONE mild torticollis 1
0168708 04/16/2001 OH 1.0 0 1 M 03/26/2001 Approximately 6 hours post vax, pt experienced swelling, redness and heat in right leg. Pt developed a fever of 102 the next day. The third day post vax, the pts fever increased to 104 with crying and tremors. Fever was up and down for five days. Physician was seen on eighth day and pt was diagnosed with an ear infection. Y Y 02/15/2001 02/15/2001 0 PUB PUB NONE NONE NONE OH0012 1
0168709 04/16/2001 OH 3.0 3 M 04/03/2001 Pt developed cellulitis at injection site right thigh. Pt was seen by physician and treated with antibiotic. Condition resolved by 03/31/2001. Y Y 03/27/2001 03/28/2001 1 NONE PUB PUB NONE - afebrile frequent om with tubes rash~Measles + Mumps + Rubella (no brand name)~1~1.00~In Patient OH0013 1
0168710 04/16/2001 CA 1.6 1 .6 F 04/06/2001 2 hours post vax, parent noticed hives, red raised whelps on pt. Rash started on legs and later noticed on abdomen as well. Denies any fever or other signs/symptoms. Pt was treated with Tylenol. Y 04/05/2001 04/05/2001 0 PUB UNK Tylenol stuffy nose and cough for two days NONE 1
0168711 04/16/2001 SC 1.0 1 .0 M 04/13/2001 Pt developed a reddened are 3cm in width on right upper thigh. Y U 04/11/2001 04/13/2001 2 PVT PVT 1
0168712 04/16/2001 MI 1.6 1 .6 M 04/04/2001 The evening subsequent to receiving vax, the pt developed a fever of 100.3 and was treated with Tylenol. One day post vax, the pt awakened with hives on feet, thighs, diaper area, arms and chest. Hives come and go in crops. Right leg mild-moderate tenderness at injection site. Y U 04/03/2001 04/04/2001 1 NONE PVT OTH Tylenol, albuterol, PPD/Connaught/C0519AA mild upper respiratory tract symptoms asthma 1
0168713 04/16/2001 MI 2.0 1 1 M 04/09/2001 2 days post vax, pt developed localized swelling and redness with warmth to left leg. The following day swelling and redness increased to 11cm with surrounding vesicles. Parent also noted behavioral changes post vax, i.e. biting and hitting family members. Y U 04/05/2001 04/07/2001 2 NONE PVT UNK NONE NONE 1
0168714 04/16/2001 KY 1.25 1 .3 M 04/10/2001 Pt developed a fever of up to 103 for a duration of 48 hours, accompanied by significant erythema, tenderness and induration of LVL. Seen in office 72 hours post vax and LVL still had residual erythema and induration (greater area than common "knot" after vax). Y Y 04/06/2001 04/06/2001 0 PVT PUB NONE NONE 1
0168715 04/16/2001 KS 2.0 2 .7 M 04/04/2001 48 hours post vax, the pt developed a half dollar sized red firm area at injection site, slightly warm to the touch and a dime sized red, firm area left inguinal area. Y Y 03/28/2001 03/30/2001 2 PUB PUB 1
0168716 04/16/2001 NY 56.0 48 M 04/09/2001 Since 1999, I have been suffering with joint stiffness and pain from my thighs up to my neck. I was in a Lyme Disease Study at a Medical Center around 1993 and I want to know if I am having side-effects from the vaccine. I have recently had an MRI of my back which shows areas of arthritis. N 01/01/1993 09/01/1999 2434 I have recently had blood work done for rheumatoid arthritis; sedimentation rate-all WNL. Recent MRI of back shows areas of arthritis. UNK UNK NONE NONE Other than joint stiffness and pain, I am a healthy 56 year old caucasian male. 1
0168717 04/16/2001 VA F 04/12/2001 On an unspecified date, the pt received her 1st dose of Lymerix. Subsequently, she reported arthralgias. As of 4/9/01, the outcome of the adverse event is unknown. Additional information has been requested. U OTH OTH UNK UNK UNK 20010091381 1
0168718 04/16/2001 TX 16.0 16 F 10/26/2000 Telephone call from pt complaining of swelling, pain and rash at site of pneumonia shot. U 10/25/2000 10/25/2000 0 PUB UNK NONE NONE TX01029 1
0168719 04/16/2001 SC 25.0 25 F 04/07/2001 Pt developed submandibular gland swelling and fever with 1st shot in the series. Her MD recommended she receive the 2nd (or continue the series) on 4/2/01. At 14:00, she received the 2nd vaccine and again developed glandular edema unilateral within 24 hours. No fever. Y 04/02/2001 04/03/2001 1 PVT PVT NONE Submandibular swelling~Hep B (Recombivax HB)~1~0.00~In Patient 1
0168720 04/16/2001 TX 5.0 1 .0 M 04/06/2001 Dx'd with varicella disease on 4/6/01 with 50-100 lesions. U 02/25/1997 04/06/2001 1501 PVT PUB NONE NONE NONE 1
0168721 04/16/2001 DC 4.0 4 M 04/09/2001 Vaccine administered IM in the right deltoid on 4/4/01 and 24 hours later, complained of itching. Mom noted red, swollen area. No fever. Had emesis and decreased activity at 36 hours, post vax, with increased swelling. Y 04/04/2001 04/05/2001 1 NONE PVT PVT Amoxicillin Under treatment for acute otitis media NONE 1
0168722 04/16/2001 SC 57.0 57 F Within 4 hours, post vax, employee states she experienced hives, welts, achy feeling all over, headache, nasal congestion and runny eyes. Y 03/08/2001 03/08/2001 0 PVT PVT NONE 1
0168723 04/16/2001 MA 8.0 8 F 04/09/2001 No data provided. Y 04/05/2001 04/07/2001 2 NONE PUB PUB NONE NONE NONE 1
0168724 04/16/2001 MD 2.0 2 .4 M 04/05/2001 Varivax in left thigh with no immediate problems. At 12 hours later, awoke with itching. Mother noticed "itching bumps" on right knee and bilateral ankles with slight "puffiness", but no fever, nausea or vomiting. Benadryl was given and resolved by morning without recurrence. Developed URI, 2 days, post vax. Y 02/15/2001 02/16/2001 1 MIL MIL NONE 1
0168725 04/16/2001 WI 5.0 5 M 04/06/2001 10cm X 11cm erythema. Y U 04/04/2001 04/05/2001 1 PVT PVT NONE NONE NONE 1
0168726 04/16/2001 NY 18.0 18 F 04/05/2001 Temperature 102F, redness, discomfort and slight swelling at site. Y 03/30/2001 04/01/2001 2 OTH PUB NONE NONE 1
0168727 04/16/2001 KS 18.0 18 F 04/06/2001 On 3/23/01, client reports that she had itching around injection site (left deltoid). She scratched area; several minutes later, her arm felt very heavy (like when I broke my collar bone); light-headedness and insides of cheeks felt swollen for 10 minutes. On 3/24/01, at 11:15 AM, "I brushed the upper park of my arm against something and 5-10 minutes later, my arm felt that same heaviness". On 3/26/01, at 09:00 AM, I "scratched area where shot was given" and arm again felt heavy, insides of cheeks felt swollen, very light-headed, slight nausea and symptoms were gone within 10 minutes. No symptoms since. Y 03/22/2001 03/23/2001 1 PUB PUB Self-diagnosed allergies to dairy products and nuts. 1
0168728 04/16/2001 OH 27.0 27 M 04/10/2001 About 30 minutes, post vax, pt felt anxious, nauseous, faint and had a funny sensation in throat. He was given .3 of Epi and Benadryl and felt better. No SOB, no tongue swelling, DTR's ok, nml exam following visit to our facility. He subsequently, visited the ER 4 times over the next 5 days with dizziness, near syncope and nausea. Received fluids and labs nml, CT Scan of head-nml. Referred to a neurologist to see on 4/21/01. Also saw PMD on 4/5/01. Symptoms wax and wan. Still having symptoms. Y N 03/29/2001 03/29/2001 0 ER evaluations; labs-nml and CT Scan of head-nml OTH PVT Mantoux/Parkdale/00540P/LFA on 3/23/01 NONE NONE 1
0168729 04/16/2001 CA 2.0 1 .1 M 04/03/2001 Contracted clinical varicella dx'd on 3/27/01. U 04/18/2000 03/26/2001 342 UNK OTH 1
0168730 04/16/2001 CA 1.0 1 .0 F 03/27/2001 Received vaccines on 3/16/01 and temperature rose to 103F but was relieved by Tylenol every 4 hours for 48 hours. Broke out in papules at injection site on right deltoid on 3/18/01 which became vesicular on 3/19/01. Y 03/16/2001 03/16/2001 0 NONE OTH PUB azithromycin Serous Otitis Media NONE CA010028 1
0168731 04/16/2001 NC 6.0 1 .3 M The pt had the varicella vaccine on 4/29/1996. He had a varicella exposure on 3/4/01. He developed varicella on 3/17/01. Pt had varicella with >700 lesions. Pt had at least 700 lesions. Y 04/29/1996 03/17/2001 1783 PVT UNK 1
0168732 04/16/2001 WI 36.0 36 M 01/26/2001 Employee was measles "non-immune" upon hire. Was given measles vaccine (monovalent) on 12/29/00. He stated on 1/8/01, had blurred vision. That week he developed joint pain. Questioning viral illness. On 3/26/01, follow-up with MD and reports related to vaccine. Y Y 12/29/2000 01/08/2001 10 CBC; Influenza swab; Sed Rate; CPK OTH PVT NONE 1
0168733 04/16/2001 CA 1.25 1 .3 M 04/06/2001 Parents give history of swelling of injection site on left thigh and complaint of febrile X 2 days. Temperature of 101F (axillary). Y 04/04/2001 04/04/2001 0 UNK UNK NONE NONE 1
0168734 04/16/2001 CA 2.0 2 .2 F 04/05/2001 Allergic reaction (hives) to vaccine; possibly Hep-A. Improved on 4/6/01. Y U 04/04/2001 04/04/2001 0 OTH PUB NONE Allergy to Penicillin 1
0168735 04/16/2001 WI 4.0 4 M 04/10/2001 On the evening of 4/6/01, left upper arm was noted to be red and swollen by mother. Taken to ER and physician documents large amount of redness and swelling and ecchymosis from left shoulder down to just above elbow. No adenopathy, lymphangitis or fever. Y U 04/05/2001 04/06/2001 1 NONE PVT PUB NONE NONE NONE 1
0168736 04/16/2001 NY 1.08 3 M 04/10/2001 Child who is under weight, came in the morning with a letter to receive his 3rd and last Hep-B vaccine. Father brought him; afebrile and no other complaints except pt does not eat well. Hep-B (Engerix-B) and PPD were done. 2 minutes, post vax, pt was sitting on a chair and slumped down and I don't know if he hit his head but father came to his aid and eyes were open. Pt recovered almost immediately. Temperature and response normal; asked "are you okay, and he nodded." Y Y 04/02/2001 04/02/2001 0 CT Scan of head by ER; Blood screen-all nml PVT PUB PPD/Mantoux test/4/2/01 NONE Child is under weight 1
0168737 04/16/2001 MI 10.0 10 F 04/11/2001 Injection given IM in right deltoid approx. 14:30 PM. Received phone call from mom about 16:15 PM, that child's arm itched severely and was getting worse, denied difficulty breathing. Instructed to give child Benadryl and take to PMD or ER. PMD gave ice bag and ASA. The people who did the vaccination, instructed mom to have Benadryl on hand for any further discomfort. In the future, mom should schedule 3rd Hep-B with PMD if he decides to allow child to have this. We will not administer the 3rd injection. Y Y 04/10/2001 04/10/2001 0 PUB PUB NONE NONE NONE 1
0168739 04/16/2001 MI 33.0 33 F 04/09/2001 Fever on 3/17/01 for a few days. Major body aches for 6 days. Severe pain in entire right arm for past 3 1/2 weeks and getting worse. Having difficulty lifting arm and states "feels sore right into the bone". Y N 03/15/2001 03/16/2001 1 PUB OTH NONE 1
0168740 04/16/2001 FL 12.0 12 F 04/13/2001 7cm X 6cm area of erythema and tenderness over left deltoid and hot to touch. Y U 04/10/2001 04/11/2001 1 NONE PVT PVT PPD/Connaught/C0520BA/LFA/1 previously in 1996 NONE Allergy to PCN 1
0168741 04/16/2001 CT 20.0 20 F 04/06/2001 Received vaccine on 4/4/01. On 4/5/01, complained of pain, swelling and numbness at right arm (shoulder to just below the injection site). On 4/6/01, symptoms the same. U 04/04/2001 04/05/2001 1 OTH OTH Multivitamins NONE Allergy to elastic 1
0168742 04/16/2001 WA 4.0 4 M 04/06/2001 Cellulitis of right upper arm below injection and injection sites and inclusive of lower injection site on 2nd day of reaction. Y U 04/04/2001 04/05/2001 1 NONE PVT PUB NONE NONE NONE 1
0168743 04/16/2001 LA 1.5 1 .6 M 04/09/2001 Shot administered on 4/5/01 to left thigh. Parents report visit to urgent care on 4/6/01. Seen in office on 4/7/01. Had a fever of 102F. Left thigh with a softball size swelling, erythematous, non-tender area, noted by MD. Y U 04/05/2001 04/06/2001 1 PVT PVT NONE NONE Allergy to Augmentin and sulfa. 1
0168744 04/16/2001 OH 3.0 2 .6 M 04/05/2001 Seen in office on 4/4/01 and dx'd with chickenpox. Y 08/29/2000 04/01/2001 215 NONE PUB UNK 1
0168745 04/16/2001 CA 1.0 1 .1 F 04/10/2001 Developed chickenpox and had already had vaccine. U 09/21/1995 04/04/2001 2022 NONE PVT PVT Spectazole cream, Lotrimin, HC cream Monilia 1
0168746 04/16/2001 SC 45.0 45 F 04/09/2001 Flu-like symptoms within 24 hours, post vax. On 3/8/01, examined by PCP and dx'd with serum reaction. Y Y 03/02/2001 03/03/2001 1 PVT PVT NONE 1
0168747 04/16/2001 CT 18.0 18 M 04/06/2001 Received vaccine on the afternoon of 4/4/01. That evening, he had a headache and spontaneous epistaxis. On 4/5/01, had epistaxis X 2 and a headache off and on. On 4/6/01, epistaxis X 1 but no headache. U 04/04/2001 04/04/2001 0 OTH OTH NONE NONE NONE 1
0168749 04/17/2001 MO 0.25 0 .2 F 04/04/2001 No data obtained. Parents are awaiting final autopsy report and the death certificate. These will not be produced until a final toxicology report is obtained. All of this is per the coroner. Autopsy states cause of death as undetermined. Death certificate states cause of death due to cerebral laceration w/open skull fracture due to an automobile accident. Y 03/21/2001 N 03/19/2001 03/21/2001 2 PUB PUB NONE Cough-lung CTA Otitis Media 2 1/2 weeks prior to immunizations MO2001021 1
0168750 04/17/2001 WA 0.5 0 .5 M 03/14/2001 This infant had no fever. 4 days of irritability, inconsolable, sleep loss, and emesis. Y 1 Y 03/09/2001 03/09/2001 0 CBC, Blood Culture. PVT PUB Albuterol Neb PRN. Teething RAD WA011741 1
0168751 04/17/2001 NY 1.4 M 07/29/2002 A nurse reported his 19 month old son received his 1st injection of Prevnar on an unspecified date. Soon afterward, the child developed injection site redness. Two months following vaccination, the child had a blood test that revealed hyperglycemia and a diagnosis of type I diabetes was made. The child was hospitalized and required unspecified intervention. The event is now being managed with insulin. Y U Blood glucose increased (hyperglycemia) PVT PVT UNK NONE UNK HQ9576511APR2001 1
0168752 04/17/2001 OR 1.2 1 .2 M 04/03/2001 Spontaneous seizure 31 1/2 hours, post vax. Mom of client noticed client to be more quiet. Taken to ER and seen for fever of 104F (R) and seizures. Temperature responded to rectal suppositories of Tylenol and po ibuprofen but a repeat seizure occurred when temperature returned. Incident lasted for 2 days. Y Y Y 2 Y 03/22/2001 03/23/2001 1 UNK PUB PUB NONE NONE NONE OR200117 1
0168753 04/17/2001 OR 0.4 0 .5 F 04/06/2001 Was taking a nap when aunt, who is also the daycare provider, checked on her. She found her not breathing and did rescue breathing and she then began to cry. Office visit to evaluate and was set up with an Apnea monitor. Y Y Y 03/29/2001 04/05/2001 7 PVT PVT Amoxicillin Bilateral otitis media 1
0168754 04/17/2001 MO 0.75 0 .8 F 04/09/2001 Seizure on 4/5/01. Y 1 Y 04/04/2001 04/05/2001 1 PVT PUB NONE NONE NONE 1
0168756 04/17/2001 CT 1.9 1 .5 M 04/11/2001 This child presented with diabetic ketoacidosis on 12/01/00. He has recovered but he has juvenile diabetes. On 10/24/00 the patient was given a Prevnar vaccine. On 11/22/00, the patient returned for a visit because he was listless, urinating excessively, and constantly thirsty. He was prescribed Amoxicillin. He was brought back to the doctors office on 12/01/00 because his just described symptoms persisted and had become worse. At this point he was diagnosed with diabetes and taken to the hospital. For the following reasons, the parents suspect that their son's diabetes was caused by the Prevnar vaccine he received : At the time he received the injection he was in good health. There is no family history of diabetes in either of the patient's parents. Diabetes in a toddler as young as the patient (then 18 months) is said to be rare. During the patient's stay at the hospital, one nurse remarked that the patient's hemoglobin count was very low for a diabetic and that the disease had not been with him for very long. According to the Prescribing Info posted by Wyeth-Ayerst Laboratories on its Prevnar web site (www.prevnar.com), diabetes was ascertained as an adverse reaction during efficacy trials of Prevnar. Therefore, the parents request that (as per the National Childhood Vaccine Inquiry Act of 1986) a report be filed with Vaccine Adverse Event Report Covering what happened to their son (a copy of the VAERS form is attached) The parents would like a copy of the filing and all attachments thereto. Kindly confirm. Y 3 Y 10/24/2000 12/01/2000 38 PVT PVT NONE NONE 1
0168757 04/17/2001 MO 62.0 61 F 04/11/2001 This patient had respiratory porplysis with Guillain Barre' Syndrome. The follow-up states that the pt's legs from her knees down and her feet are still numb. She has trouble wearing shoes and she states that it's very painful. Doc 212822, annual follow up, states numbness in feet and up front of legs, weakness in legs. Y Y N 11/18/2000 11/19/2000 1 PVT OTH Angina,GERD, Hyperlipodemia 1
0168758 04/17/2001 AR 0.6 0 .6 M 04/06/2001 The pt received vaccines on 4/5/01 at approximately 9:00 am. Was presented to ER at 7:30 PM with a seizure. Transferred to the hospital. CT Scan revealed possible hydrocephalus. Y Y Y 04/05/2001 04/05/2001 0 CT of head - possible hydrocephalus PVT PUB rhinitis, tinea corporis NONE 1
0168760 04/17/2001 CO 4.0 4 M 04/02/2001 Pt developed a low grade fever (100), listlessness, malaise and decreased appetite the morning following receipt of vax. Later that day the pt developed large red blotches on each thigh, left 3-4 inches, right 4-5 inches, that were swollen and hot. Blotches still there, though improving. Y 03/30/2001 03/31/2001 1 NONE PUB PUB NONE NONE NONE CO01004 1
0168761 04/17/2001 TX 1.5 1 .5 M 04/02/2001 18 hours post vax, the pt experienced swelling and redness of right thigh, with no fever or tenderness. Y 03/28/2001 03/29/2001 1 NONE PUB PUB NONE NONE NONE 1
0168762 04/17/2001 IL 6.0 6 F 04/09/2001 Pt experienced a local reaction of redness and swelling the same day of receiving vax. Pt seen by physician three days post vax with redness the size of palm of hand extending downward from the injection site. Redness lasted for 5 days per parent. Y 03/23/2001 03/23/2001 0 NONE PVT PUB NONE NONE NONE 1
0168763 04/17/2001 IL 2.0 2 .0 M 04/11/2001 One day post vax, pt refused to walk on his right leg, complaining that it hurt. Pt is a twin. His sibling also received Prevnar and refused to walk on her leg that day. Y 04/02/2001 04/03/2001 1 NONE PVT PVT NONE NONE NONE 1
0168764 04/17/2001 IL 2.0 2 .1 M 04/03/2001 Two days post vax, the pt developed a fever of 103.4. Fever on and off since that time, accompanied by decreased appetite and fatigue. On 03/26/2001 pt was seen in the office with fever still present. Ears and throat normal, chest clear, no adenopathy, rash or redness at injection site. Y 03/22/2001 03/24/2001 2 NONE PVT PUB NONE cold NONE 1
0168765 04/17/2001 CA 1.25 1 .3 M 04/10/2001 Pt taken to ER 04/08, 04/09 and 04/10 with rash and urticaria involving entire body accompanied by low grade fever. Y 04/06/2001 04/07/2001 1 PVT PUB NONE NONE 1
0168767 04/17/2001 NJ 0.6 0 .5 M 04/13/2001 A few hours post vax, the pt developed bumps at and around the injection site. The rash persisted for almost one week and disappeared. Pt treated with cold compress and Benadryl. Y 03/22/2001 03/22/2001 0 NONE PVT PUB NONE Pt experienced vax adverse reaction to Comvax, DTAP, and IPV on 02/08/2001 1
0168768 04/17/2001 WA 0.2 0 .2 F 02/13/2001 An infant had "tremors" approximately lasting 2 seconds in first 2 hours after Prevnar. When seen by the clinic, no abnormal neurological findings. Y 02/13/2001 02/13/2001 0 PVT PUB WA011739 1
0168769 04/17/2001 TN 1.0 1 .0 F 03/29/2001 Six days post vax the pt broke out with chicken pox. Pt had over 100 lesions on 03/22/2001. As of 03/28/2001 the pt had chicken pox and a fine red raised rash. Y U 03/16/2001 03/22/2001 6 PUB PUB NONE NONE TN01013 1
0168770 04/17/2001 MD 62.0 60 M 04/12/2001 After 4-5 months, joints and muscles aches became evident. Very stiff conditions, the doctor advised to take 400 units of Ibuprofen 3 times a day. Continues till this day. No other doses given due to problem. Y N 01/17/2000 04/01/2000 75 NONE PVT PVT Amaryl, Glucophage, Lipitor, Aspirin. NONE Diabetic and Cholesterol control. 1
0168771 04/17/2001 GU 23.0 M 04/06/2001 This patient had a bump at his injection site approximately 1 cm x 1 cm with severe itching,. Appears 1-2 times a month. The follow-up states,"partially recovered and still gets small bumps that come and go in the evening with mild itching." Y 04/05/2001 MIL MIL NONE 1
0168772 04/17/2001 WA 49.0 49 F 03/06/2001 This patient had a headache 11/14 thru 11/18, urinary incontinence, depth perception problems, and visual blurring. U 10/16/2000 11/14/2000 29 Neurology/ Ophthalmology evaluations, MRI of the brain. MIL MIL NONE NONE Class I latex allergy. Allergic to Septra and Copalite. WA011731 1
0168773 04/17/2001 IL 9.0 9 M 04/10/2001 This child was positive for chicken pox, tactile temp for 2 days, less than 50 lesions. 3 siblings, mother , uncle , and housemate, positive for chicken pox. Y 03/15/2001 03/26/2001 11 NONE OTH PUB NONE NONE NONE 1
0168774 04/17/2001 IL 7.0 7 F 04/10/2001 Positive chicken pox, less than 50 vesicles, no fever. The patient received Varicella immunization on 03/15/01. The mother broke out approximately 03/24/01, 2 other siblings broke out, then the patient, then 1 other sibling, and a housemate. Y 03/15/2001 03/25/2001 10 NONE MIL PUB NONE NONE NONE 1
0168775 04/17/2001 IL 5.0 5 M 04/10/2001 This patient received Varicella immunization on 03/14/01. One other sibling received vaccination on 03/14/01, 2 other siblings received immunization on 03/15/01. The mother broke out on 03/24/01. 2 other adults in the home broke out. The patient had 50 + lesions, 1 - 2 tactile temp. Y 03/14/2001 03/26/2001 12 NONE OTH PUB NONE NONE NONE 1
0168776 04/17/2001 IL 2.0 2 .5 M 04/11/2001 This patient received (03/15/01) immunization. On 03/15/01, broke out approximately on 03/24/01 he had a temp of 101.1. On 04/02/01, tactile temp. The patient presented to the clinic on 04/02/01 with a temp of 101.1, cough x 4 days, + rales, and + wheezing. The patient was treated in the ER on 04/02/01, + retractions, 96% O2 sat, Chest x-ray - mild hyperinflation. The mother, 3 siblings, uncle, and housemate (adult), all + for chicken pox. Y Y 03/15/2001 03/24/2001 9 Chest x-ray no infiltrate mild hyperinflation. PUB PUB Albuterol NONE NONE 1
0168777 04/17/2001 NJ 4.0 4 F 04/12/2001 This child had a local reaction, 6 cm diameter, erythematous, macular rash at the injection site (right ant thigh) with slight tenderness; 24 hours after injection of IPV. Treated with ice and Benadryl, follow up if not resolved. Y N 04/01/2001 04/11/2001 10 Physical exam. PVT PVT NONE NONE NONE 1
0168778 04/17/2001 CA 9.0 9 F 04/12/2001 About a half hour after the vaccine, the patient fell to the floor, eyes rolled back, lasted a few seconds. The mother claims she had a similar reaction after Hep B vaccine in March of 1999. Y 04/12/2001 04/12/2001 0 NONE PVT PUB NONE NONE History of febrile seizures at a younger age. 1
0168779 04/17/2001 MI 1.0 1 .1 F 04/10/2001 4 x 1 cm of redness in right leg, some slightly increased warmth. Y 04/04/2001 04/05/2001 1 PVT PVT 1
0168780 04/17/2001 CO 1.7 2 .2 F 01/24/2001 This child had pain in the left thigh and diffuse swelling from the groin to the knee. Y U 01/22/2001 01/23/2001 1 PVT PVT NONE NONE Congenital cyst left lung, polycystic kidneys. CO01003 1
0168781 04/17/2001 CO 6.0 6 M 03/21/2001 Swollen lymph node under his right arm pit, no redness noted. Doctors appt today at 4 PM. He had a temp of 99.7 with Tylenol, flushed cheeks, and swollen tonsils. Throat culture done, no Strept, no redness, or swelling at the injection site. Y Y 03/20/2001 03/21/2001 1 PUB UNK Viral infection. NONE CO01005 1
0168782 04/17/2001 MI 7.0 M 04/03/2001 This patient had a varicella rash, noted on 03/31. Seen in the office today 04/03. Y 03/31/2001 PUB UNK 1
0168783 04/17/2001 VA 31.0 31 F 04/10/2001 This patient had a 2.5 cm induration and erythema. Y 04/08/2001 PVT UNK PPD, Connaught, Lot #CO578AA, left arm. BCP. NONE Drug allergy - Amoxicillin. 1
0168784 04/17/2001 OH 10.0 10 F 04/09/2001 This patient had Bell's Palsy onset 2 days after his immunization. No specific treatment other than natural tears and toning of affected eye. Bell's Palsy resolved by 04/21/2001 U 04/02/2001 04/03/2001 1 PVT PVT Serous Otitis secondary to allergies. NONE 1
0168785 04/17/2001 CA 4.0 4 M 04/06/2001 This child had left arm pain, swelling, and redness at the injection site. Y Y 04/03/2001 04/04/2001 1 PVT PUB Tylenol NONE NONE 1
0168786 04/17/2001 FL 9.0 8 F 04/07/2001 This child received 3rd Hepatitis B vaccine on 10/30/00 ( previous doses given 10/29/96 and 08/05/98). She developed a knot at the site of injection (left deltoid) which persisted but not reported until 02/06/01 when she developed redness and multiple small sq papules within the area of erythema. She was treated with Augmentin for 10 days for possible cellulitis. She returned 03/14/01 with 2 1/2 by 1/1/2 inch area of persistent induration, violaceous with central tenderness. Treated with 10- day course of Duricef. On 03/29/01, the lesion was essentially the same and she was referred to dermatology. They diagnosed a morphea-like reaction which they felt was due to a localized hypersensitivity response to Hep B vaccine, which might arrest with time, or continue to smolder. The lesion measured 6.5 cm by 4.5 cm. Dovonex Ointment was prescribed, and in one month if the lesion still expanding, will receive intralesional injection of triamcinolone. Y N 10/30/2000 02/06/2001 99 NONE PVT PVT NONE NONE NONE 1
0168787 04/17/2001 CT 19.0 19 F 04/10/2001 Pt received vaccine on 4/4/01. On 4/7 she complained of fever/chills, nausea, and headache. Sx still present on 4/9 when seen in clinic. Given Brat diet to follow and advised to take Tylenol. U 04/04/2001 04/07/2001 3 OTH OTH NONE NONE PCN allergy 1
0168788 04/17/2001 LA 2.0 2 .1 M 04/12/2001 This patient came to my home at 10:30 PM on 04/11/01. The grandmother states that her daughter noticed redness in the Am on 04/11/01 with progression that evening. Unk fever. Assessment revealed erythema and induration of approximately 12 cm on the right and left thigh. The area was hot to touch. The child was trying to scratch the areas. Palpable nodule at both sites. Talked with the patient's mother on 04/12/01. Talked with the PMD, if not better by 04/13/01, the patient is to go see the PMD. U 04/10/2001 04/11/2001 1 PUB PUB NONE Allergic to eggs, and cashews. 1
0168789 04/17/2001 WA 43.0 43 F 03/25/2001 This patient's arm had swelling, red, hot, tender to touch with multiple hives moving up her arm to her neck and across the chest. Tongue felt numb. Took Benadryl and put ice on her arm, the next day it was not noticeable. Y 03/16/2001 03/16/2001 0 PUB UNK Albuterol, Celebrex, Flovent, Flonase. NONE Allergic to bee stings, some trees, cats, dust mites, and weeds. WA011745 1
0168790 04/17/2001 WA 4.0 3 M 03/20/2001 Erythematous, macula measuring approx. 7mm, poorly demarcated with a 4mm induration, cool to touch to right deltoid. Have tried to contact but unable to reach. U 03/14/2001 03/16/2001 2 PVT OTH NONE NONE NONE WA011744 1
0168791 04/17/2001 WA 39.0 39 F 03/09/2001 5-6 days, post vax, left arm was swollen and red, hot, burning and itchy and discolored. Had a low-grade fever, then aches and pains all over. Then arm was even more sore, swollen and hurt under her arm so she saw a doctor on 3/8/01. Treated with Keflex 500mg. Fever broke on night of 3/8/01. Y Y 02/27/2001 03/03/2001 4 NONE PUB UNK NONE NONE WA011743 1
0168792 04/17/2001 WA 0.2 0 .2 F 03/19/2001 Mother reported 6 hours of inconsolable crying, 1 day, post vax. She wasn't sure if it was due to shots or constipation. Y 12/19/2000 12/20/2000 1 PVT PUB NONE NONE WA011742 1
0168793 04/17/2001 WA 22.0 23 M 03/21/2001 On 3/19/01, fever and complained of cold; don't know what temperature was. Went to bed and wrapped in blankets. That night his wife noted a few "red bumps on his back". Today, multiple red spots, (fluid-filled) on back, stomach, legs, hair line and "all over". per his wife, probably >50. U 03/07/2001 03/19/2001 12 PUB PVT NONE NONE NONE WA011740 1
0168794 04/17/2001 WA 0.2 0 .2 F 02/22/2001 Inconsolable crying within 1 hours of vaccine. Lasted more than 3 hours. Y 02/15/2001 02/15/2001 0 PVT PUB NONE NONE WA011738 1
0168795 04/17/2001 WA 0.2 0 .2 F 02/22/2001 Inconsolable crying for 3 hours, within 1 hour of vaccine. Y 02/22/2001 02/22/2001 0 PVT PUB NONE NONE WA011737 1
0168796 04/17/2001 WA 0.2 0 .2 M 02/22/2001 The pt experienced inconsolable crying within 1 hour of vaccine lasting 3 hours. Y 02/13/2001 02/13/2001 0 PVT PUB NONE NONE WA011736 1
0168797 04/17/2001 WA 0.2 0 .2 M 02/22/2001 The pt experienced inconsolable crying for 3 hours within 1 hour of vax. Y Y 02/20/2001 02/20/2001 0 PVT PUB NONE NONE WA011735 1
0168798 04/17/2001 WA 0.2 0 .2 M 02/22/2001 The pt experienced inconsolable crying for 3 hours within 1 hour of vax. Y 02/15/2001 02/15/2001 0 PVT PUB NONE NONE WA011734 1
0168799 04/17/2001 WA 5.0 5 F 03/11/2001 Vaccines were given on 3/9/01. On 3/10/01 the mom noticed increased erythema. The child complained of severe pain in the left arm. The child had a temp of 101-103. On 3/12/01 the erythema covered an area of 10 x 20cm that was indurated and warm. Y U 03/09/2001 03/11/2001 2 PVT PUB NONE localized swelling~DTP (no brand name)~3~0.00~In Patient WA011733 1
0168800 04/17/2001 WA 1.0 1 .0 F 03/14/2001 Vaccine administered on 3/1/01. Broke out with a rash on legs and increased on 3/8/01. Increased rash to torso; rash is itching. Advised to bathe with Aveeno or oatmeal. Y U 03/01/2001 03/08/2001 7 NONE PVT PUB Pulmicort; Albuterol Reactive Airway Disease; Eczema WA011732 1
0168801 04/17/2001 TN 3.0 3 M 04/06/2001 Bruise at injection site with red rash noted 3-4 days, post vax. Rash in semi-lunar configuration on left thigh about 5cm in diameter. Y Y 03/30/2001 04/02/2001 3 PVT PUB NONE 1
0168802 04/17/2001 NC 4.0 4 M Left arm swollen and red to elbow. PHN had pt's mom to take to MD. MD told mom to give Benadryl and cool compresses to area and that it was a reaction to whooping coughing per grandfather. U 04/01/2001 04/03/2001 2 PUB PUB Allergies to pollen NC01042 1
0168803 04/17/2001 RI 56.0 55 M 04/06/2001 Pt received the Hib vaccine. Y 02/16/2001 02/16/2001 0 MIL MIL NONE 1
0168804 04/17/2001 NE 77.0 77 F 03/19/2001 When pt went to bed on the day of the injection, it was quarter-sized. Now, this AM, well defined borders that is warm but not fluctuant. More pinkish in color. Measures 9cm X 5.8cm and a curvilinear area of redness above this but away from it, that extends into the axilla. Temperature is 99.4. Y 02/22/2001 02/23/2001 1 PVT PVT NONE 1
0168805 04/17/2001 PA 0.9 1 .1 M 04/09/2001 Rash started on 4/7/01 with a few on trunk and arms. No itching. Temperature 99F (oral). Seen in office on 4/9/01 with 30 varicella lesions. Y 10/22/1997 04/07/2001 1263 NONE PVT PVT TB Tine/Connaught/M09754/Skin test/0 previously NONE NONE 1
0168806 04/17/2001 FL 1.0 1 .0 F 04/09/2001 15-20 lesions, temp. U 08/19/1997 04/08/2001 1328 NONE PVT PVT NONE NONE 1
0168807 04/17/2001 FL 12.0 12 F 03/27/2001 Headache, arthralgias and fatigue X 2 weeks. Y 03/01/2001 03/02/2001 1 CBC; Mono; Strept; Creatine Protein; ANA PVT UNK Ginger, Feverfew, Bryani, Motrin Allergy to PCN, Cefzil, Bactroban 1
0168808 04/17/2001 FL 3.0 3 F 04/15/2001 Pt with circumferential swelling in left upper arm, around area of administration. Within 48 hours, had increase of swelling and erythema. Is recovering. U 04/11/2001 04/12/2001 1 NONE PVT PUB NONE NONE NONE 1
0168809 04/17/2001 AZ 2.0 2 .0 F 04/13/2001 Extreme swelling and redness of both palms and all fingers within 30 hours after Hep-A vaccine. Required ER visit and pain medication. Y Y 03/30/2001 03/31/2001 1 NONE PVT PVT NONE NONE Recurrent otitis media 1
0168810 04/17/2001 GA 42.0 42 F 04/16/2001 The pt experienced soreness to the left arm for several weeks, then soreness with deep pain. The pt experienced numbness in Index and thumb. Was seen by a doctor on 2/27/01 and one more time since. Pain medication provided no relief. Placed on steroids with little relief. Appointment on 4/23/01. Y N 01/09/2001 01/09/2001 0 PUB PUB NONE NONE 1
0168811 04/17/2001 WA 1.0 1 .0 M 04/06/2001 The pt experienced a red lesion with mass indurated below with an abscess to the right proximal thigh that covered an area of 1.5 x 2 cm. Temp of 101 for over 3-4 days. Treated with Keflex. Y Y 03/27/2001 03/31/2001 4 NONE PVT PUB Tylenol NONE NONE 1
0168812 04/17/2001 IL 17.0 17 M 04/10/2001 The pt had a severe headache, fever, and dizziness. The pt was given Motrin. Y 03/30/2001 03/30/2001 0 PVT PVT NONE NONE seasonal allergies 1
0168813 04/17/2001 WI 4.0 1 .1 M 04/09/2001 The pt experienced about 24 chicken pox, itching and no fever. Y 06/04/1997 04/01/2001 1397 PVT OTH NONE NONE NONE` 1
0168814 04/17/2001 NY 31.0 31 F 04/11/2001 The pt experienced onset 2 hours post yellow fever vax. The symptoms experienced were redness, swelling. Was seen the next day. Injection site was warm and swollen. Pt complained of numbness. Sensation was in entire right arm but had good strength. Y U 04/09/2001 04/09/2001 0 NONE PUB PUB NONE NONE NONE 1
0168815 04/17/2001 AR 0.2 0 .2 F 02/23/2001 The baby quit eating, was slightly dehydrated, weakness and very lethargic. Baby was taken to ER and admitted. IV fluids were given. Spinal tap, brain scan and blood work were neg. Transported to another facility. EMG showed a diagnosis of acute inflammatory axenal neuropathy. IVIG given. Also diagnosed with thrush. Y Y U 01/25/2001 02/18/2001 24 Blood work, EMG, Brain Scan, Spinal Tap - all Nml except EMG - showed muscles getting signal from the brain, but not working. PUB UNK NONE NONE thrush AR0123 1
0168816 04/17/2001 AR 11.0 11 M 03/21/2001 The mother states the pt developed a low grade fever 24 hours post vax. 48 hours post vax, the pt developed a fever of 105. The pt was given Advil. Advised to call doctor if fever does not decrease. On 3/22/01, the pt was seen by PMD who states the pt had a "virus". Y Y 03/19/2001 03/21/2001 2 chest x-ray, physical PUB PUB NONE NONE NONE AR0122 1
0168817 04/17/2001 OK 1.25 1 .2 F 03/24/2001 Pt developed a widespread maculopapular rash with onset 03/20/2001. Pt was seen in ER and thought to be secondary to amoxicillin, but antibiotic changed and rash still spreading. Rash worsening when checked in office on 03/23/2001. Pt also experienced a low grade fever. Y 03/12/2001 03/20/2001 8 NONE PVT PUB Amoxicillin; Zithromax; Fluoride drops, IPV by Connaught was also given on 3/12/01. Lot #R1346 Clinical sinusitis NONE AR0120 1
0168818 04/17/2001 KY 0.75 0 .8 F 04/11/2001 The pt experienced a rash on the face, trunk and extremities starting the next morning. Benadryl recommended. U 04/10/2001 04/11/2001 1 PVT PUB NONE NONE 1
0168819 04/18/2001 VA F 04/11/2001 It was reported that prior to vaccination, the pt was asked by the health care provider if she was pregnant or planned to get pregnant and the woman said no. The pt's husband later told the health care provider that the woman was pregnant, but hadn't wanted to say so in front of the other children. A pregnancy test was done which confirmed she was 4-8 weeks pregnant. The woman made an appointment with her ob/gyn for two weeks later. When the woman arrived at the doctors office, she was spotting and she miscarried. A D&C was done. No further information was available. Y N Beta-human chorionic- (+) 4-8 weeks pregnant OTH OTH UNK Pregnancy-LMP-UNK WAES01040513 1
0168827 04/18/2001 KY 1.0 M 12/21/2001 Information has been received from a mother concerning her 12 month old son with no past medical history or allergies who on 1/5/01 was vaccinated with 1 dose of varicella virus vaccine live in the left leg and 1 dose of Hep-B in the right leg. He also had poliovirus and DPT in the left leg. Approx. 1 week, post vax, the pt developed vomiting, severe diarrhea, fever of 104F, dehydration and itching and swelling at the injection site, "left leg was swollen with a black dot in it, like a bruise." The child would often "stiffen up and scream with a high-pitch sound". On 1/15/01, the pt was hospitalized. The pt was tested negative for Rotavirus and was released on 1/16/01. The pt was hospitalized again on 1/17/01 with the same symptoms. The pt was released from the hospital on 1/21/01 and the mother reported that the child still had diarrhea for several days later. The reporter stated that the child was dx'd with a "virus". It was noted that the pt's symptoms have now resolved. Additional information has been requested. Y Y Y Y 01/05/2001 01/12/2001 7 Lab for Rotavirus on 1/15/01 was negative. OTH OTH antimicrobiel otic infection WAES01012085 1
0168831 04/18/2001 PA 52.0 51 F 04/08/2001 From August, 2000, to present 4/01 have had fatigue; aches; headaches; joint pain (all joints); nerve pain; fevers; now, extreme pain in joints and nerve spasms, constant fatigue and frequent headaches. Ongoing. Y Y N 08/01/2000 04/01/2001 243 PVT OTH NONE NONE 1
0168832 04/18/2001 CA 12.0 12 M 04/02/2001 Pain right deltoid and shoulder, more prominent in shoulder region. Denies fever. Full movement of arm. No redness. Slight edema noted. Pt's return to clinic was 2 days, post vax. Pt's mother could not wait and went to own MD on Monday, after injection, then to ER for admitting. Diagnosis: septic shoulder Y 18 Y 02/28/2001 03/05/2001 5 Says see attached, but no data attached. OTH OTH NONE NONE NONE 1
0168835 04/18/2001 IL 0.2 0 .2 F 04/11/2001 Inconsolable crying which began immediately, post vax. A follow up report received 4/19/2001 adds: Fever 104 degrees taken by "pacifier thermometer". Y Y 1 Y 03/28/2001 03/28/2001 0 Spinal Tap PUB PUB NONE NONE NONE 1
0168836 04/18/2001 NE 1.25 1 .2 M 04/11/2001 This infant had a fever of 104 F the day of his vaccine. He then had a fever of 104 F, cough, stridorous retractions, hypoxic, requiring intubation for subglottic stenosis. 2 days after the vaccinations he was given IV antibiotics. Until cultures returned with negative results. He was found to be neutropenic. The patient developed DVT requiring anticoagulation. Y Y Y 12 Y 03/28/2001 03/28/2001 0 Blood cultures, brochioalveolar lavage with negative cultures, influenza and para influenza (-). RSV (-). Neutropenia. PVT PVT NONE NONE NONE 1
0168838 04/18/2001 GA 1.6 1 .6 F 04/12/2001 Pt began wheezing accompanied by fever on the day of vax. Two days post vax, pt continues to have fever and wheezing, parent advised to treat with Motrin and seek medical attention. Y Y 04/10/2001 04/10/2001 0 PUB PUB NONE NONE NONE 1
0168839 04/18/2001 MN 0.3 0 .3 M 04/05/2001 Pt had a blotchy rash on scalp, neck, forehead and cheeks that increased from 2 days prior to vax. Pt was treated with hydrocortisone. U 04/03/2001 04/05/2001 2 NONE PVT OTH NONE eczematous dermatitis 1
0168840 04/18/2001 CO 0.6 F 04/12/2001 Hard lump and red spot at injection site with 1/2" X 1" induration. Slight irritability. N 04/10/2001 NONE PVT UNK NONE 1
0168841 04/18/2001 IL 2.0 U 04/10/2001 One day subsequent to receiving vax, pt woke up rubbing injection site and complaining of pain. Pt refused to walk on leg when taken to day care. Pt is a twin and sibling also suffered leg pain following vax. U 04/02/2001 04/03/2001 1 NONE PVT PVT NONE NONE NONE 1
0168842 04/18/2001 WA 1.25 1 .3 M 03/21/2001 Swelling and redness of right upper arm from deltoid area to elbow with edema of forearm and hand began one day post vax. Pt seen two days post vax at height of erythema/edema. Pt treated with Tylenol, Benadryl and topical HC. Y Y 03/12/2001 03/13/2001 1 PVT PUB residual serious middle eat effusions and mild eczema WA011746 1
0168843 04/18/2001 NM 0.08 0 .1 M Within 24 hours post vax, pt developed a morbilliform rash accompanied by fever of 101. Y 04/10/2001 04/11/2001 1 NONE PUB PUB NONE chronic congestion NONE 1
0168844 04/18/2001 CA 1.08 2 .1 F No data provided. A follow up report received 4/20/2001 adds: On evening of the Prevnar immunization (no other immunizations were given that date) mom noted redness, warmth and swelling at the injection site. The following day, the site was still warm and the redness and swelling was more extensive, approx 3 inches across the left arm. Mom also noted that the fingers and toes of both hands and feet were swollen and itchy. Mom called pediatrician and was advised to give Benadryl. Symptoms subsided quickly and are fully resolved. Y 02/26/2001 02/27/2001 1 PVT PVT NONE NONE 1
0168845 04/18/2001 MO 47.0 46 F 12/01/2000 On 2/12/00, received 1st Anthrax vaccine and had mild flu-like illness, fatigue, headache and dry skin which occurred 2 days, post vax, and lasted 1 week. On 2/26/00, received 2nd Anthrax shot and had flu-like symptoms (more severe and overwhelming fatigue and severe headaches). Vomited X 2, unable to sleep for several days. Had large swelling at injection site involving entire upper arm. Symptoms have improved but are still present. Y Y 02/26/2000 02/28/2000 2 MIL MIL NONE NONE NONE 1
0168846 04/18/2001 27.0 26 M 04/02/2001 Continuous headache, starting 5-10 minutes, post vax, and lasting 7-10 days. Follow up: Patient partially recovered from adverse event. Headaches 3-5 days a week lasting 5-12 hours. Patient received further shots since reported event. Still receiving headaches, received shot same day I was evaluated shot was administered after evaluation. Y 03/05/2000 03/06/2000 1 MIL MIL NONE NONE 1
0168847 04/18/2001 HI 25.0 23 M Would develop welts on arms and legs at unpredictable periods. Welts would spread throughout body. Had unpredictable swelling of lips that did not occur before vaccination of 4th Anthrax. Had 1st Anthrax on 3/21/99; 2nd on 4/3/99; 3rd on 4/17/99; 5th on 3/18/00 and vaccinations ceased due to health concerns. Follow up: Patient did not recover from adverse event. Patient did not receive any more shots since reported event. N 11/20/1999 11/20/1999 0 Blood test done twice by PMD MIL MIL NONE Allergy to Penicillin 1
0168848 04/18/2001 KS 37.0 35 M 01/29/2001 Had swollen and painful joints that will not get better; fibromyalgia; anxiety and fatigue. Treated with heat and cold compresses and ultrasound and anti-inflammatories. Follow up: Follow up in 2 weeks, may need to have Rheumatologist to confirm. Not sure what cause these episodes of wheels, muscle and joint aches and fatigue. Patient claims that immediately after the anthrax shots in 98, there were these. Symptoms now they are persisting. At same time however also had a lot of terrible personal problems and unfaithful wife who gave him some diseases taht the patient didn't treat adequately. Follow up: Patient did not recover from adverse event. Patient's current duty status is light duty. Patient still being evaluated for possible administrative separation. Approximately 60 days due to time lost getting treatment and doctor visits. Patient has been evaluated by a physician or health care provider, but all assure me that side effects are temporary; thus my conditions is not related. Names are attached on copies of records; however I believe those side effects are not going away. Patient did not receive any further shots since reported events. Y N 09/28/1998 09/28/1998 0 Negative results; positive hyplorivirus; Fibromyalgia MIL MIL acyclovir HS-2/Flue 1
0168850 04/18/2001 VA 30.0 30 F 04/13/2001 Joint stiffness, pain in neck, back, hips, shoulders and hands. Pain occurred one week after vaccine. First sign was migraine that went into back and hips. Pain is increasing and continues. Immediately felt sick (1 to 2 hours, post vax, had migraine). N 07/13/2000 07/20/2000 7 X-rays, Blood test for Lyme Disease PVT UNK Synthroid; Mircette NONE Plate in head (no adverse condition) 1
0168851 04/18/2001 MD 1.0 0 .5 M 04/13/2001 Evening of 10/8/00, began with low-grade fever (<101F); irritability; constant crying and on 10/9/00 had rash over body (low, red bumps); breathing difficulty with short, rapid and shallow breaths and lethargy. Y 10/02/2000 10/08/2000 6 PVT OTH NONE 1
0168852 04/18/2001 CA 11.0 10 M 04/03/2001 Conjunctivitis and itching within 1 hour of first Hep-B. Y Y 11/06/2000 11/06/2000 0 NONE PVT UNK NONE History of environmental allergies; hives 1
0168853 04/18/2001 CA 3.0 2 .7 M 04/03/2001 Warmth, edema, erythema at injection site on left deltoid; induration and pain less than 24 hours, post vax. Y Y 12/14/2000 12/15/2000 1 NONE PVT UNK 1
0168854 04/18/2001 SC 4.0 4 M 03/02/2001 Mom called on 3/2/01 to report a temperature of 105F (po) after receiving shots the day before. Pt presented with elevated temperature on 3/1/01 at approx. 15:00. Temperature remained elevated for 24 hours. Mom also reported "sweatiness and clammy". Symptomatic care was advised by the physician. No other signs or symptoms noted but needed relevant tests or lab data. Y Y 03/01/2001 03/01/2001 0 Needed related tests or lab data PUB PUB NONE NONE NONE SC0120 1
0168855 04/18/2001 FL 9.0 9 M 04/04/2001 Pt fainted approx. 4-5 minutes, post vax. He had twitching of arms, legs and mouth; lethargic; nausea; excessive sleepiness; diaphoretic and vomited. Observed X 30-45 minutes. Y 03/20/2001 03/20/2001 0 BP-118/60; R-18; P-96 PVT PVT NONE NONE NONE 1
0168856 04/18/2001 OH 3.0 1 .0 U 04/11/2001 Shingles; right eye; 2 1/2 years after vaccine. Left eye pain; photophobia; lethargy and increased sleeping. Started with intense pain and photophobia of right eye followed 48 hours later with vesicular rash (forehead and scalp to just below lower lid). Y Y 09/17/1998 03/29/2001 924 CBC & diff-wnl Tzanck Smear-positive for herpes zoster; HBV culture-neg; CSF-wnl; Metabolic panel-wnl; Blood culture-neg; ESR-neg. OTH OTH 1
0168857 04/18/2001 MI 46.0 46 F 04/05/2001 5 days, post vax, left upper arm became swollen, red, warm and painful. Area of redness 36mm X 48mm. Y Y 03/30/2001 04/05/2001 6 NONE PVT OTH Vitamins NONE 1
0168858 04/18/2001 KY 1.5 1 .5 M 04/11/2001 Post vax, later that day, pt had temperature of 102F for 8 hours. He was a little fussy on 4/10/01. On 4/11/01, at 01:00 his temperature was 102F-103F and vomiting. Mother states right leg was swollen on 4/11/01. She took infant to MD on 4/11/01 and he was started on antibiotic and will see MD on 4/13/01 for follow-up. Y Y 04/09/2001 04/09/2001 0 PVT PUB KY2001026 1
0168859 04/18/2001 MA 28.0 28 F 04/06/2001 Neck pain radiating to back and down spine; chills; a little trouble breathing and soreness at site on left arm. No obvious distress. Y U 04/06/2001 04/06/2001 0 T-99.6F; P-66; R-24; BP-98/70 PUB OTH OCP; Vicoprofen prn; hydroxyzine NONE NONE 1
0168860 04/18/2001 TN 1.0 1 .1 M Temperature 104F occurred within 24 hours and 2 brief shaking spells (several seconds duration). Y U 04/04/2001 04/05/2001 1 PVT UNK NONE 1
0168861 04/18/2001 WA 1.5 1 .5 M An 18 month old boy was given MMR, Hib and DTAP on 3/30/01. Started having red pinpoint rash on the back on 4/8/01. Now with fever of 101.7F and rash spreading to the abdomen and neck. Y U 03/30/2001 04/08/2001 9 PVT PUB Amoxicillin Left otitis media Caudal regression syndrome 1
0168862 04/18/2001 IL 1.0 0 .8 F 04/06/2001 No data provided. U 03/22/2001 04/02/2001 11 PVT PVT 1
0168863 04/18/2001 31.0 31 M 04/11/2001 On 4/2/01, the pt came to medical for a cut on his index finger to be taken care of. He was also given an IM dose of TD in right deltoid muscle. On 4/4/01, the pt came back to medical, complaining of allergic reaction to injection site with redness, warmth, edema, induration with tenderness. He also complained of dragging and heavy sensation to the area and his armpit. Y U 04/02/2001 04/02/2001 0 UNK UNK Pt has no known drug allergies and pt has received tetanus shot before without problem or reactions. 1
0168864 04/18/2001 CO 45.0 45 F 04/11/2001 Client complained of pain, swelling and erythema at injection site. Onset 4/7/01 and duration 4/9/01. Treatment: none required. Y 04/06/2001 04/07/2001 1 PUB PUB NONE NONE Asthmatic; Allergic to Demerol; Hypercholesterolemia 1
0168865 04/18/2001 FL 5.0 3 M 04/11/2001 Pt had chickenpox, despite receiving the vaccine. Y 05/21/1999 03/28/2001 677 PVT PVT NONE NONE Has autism 1
0168866 04/18/2001 FL 27.0 27 M 04/13/2001 On 4/12/01, stiff neck, trouble swallowing and trouble moving neck. No medication. Referred to PMD. U 04/12/2001 04/12/2001 0 On 4/13/01, BP-151/89; P-85; R-16; T-98.6F OTH UNK NONE NONE NONE 1
0168867 04/18/2001 WA 1.3 1 .3 M 04/13/2001 Approx. 4 hours, post vax, mom noticed increased fussiness, complaining of leg pain and stiffness, non-weight bearing. Mom took child to ER with a questionable dx at the hospital. Today, he is moving better but slower than normal. Y Y 04/12/2001 04/12/2001 0 PVT PUB NONE NONE Mild pulmonary valve stenosis 1
0168868 04/18/2001 ND 1.2 1 .2 M 04/11/2001 Child received immunizations and about 12 hours later, developed a non-itchy rash all over his body except on back. No temperature. Rash began fading, 24 hours, post vax. Y 04/09/2001 04/09/2001 0 PUB UNK Finished antibiotics on 4/8/01 1
0168869 04/18/2001 OR 37.0 37 F 04/11/2001 Erythema and induration of 45mm X 55mm at the injection site, 7 days, post vax. Pt complained of tiredness. Y 04/03/2001 04/09/2001 6 NONE OTH PUB NONE NONE 1
0168870 04/18/2001 CO 33.0 33 F 04/12/2001 Client complained of pain, swelling, erythema at injection site. Onset on 3/13/01 and lasted until 4/12/01. Treatment: advised client to see PCP for evaluation. Y U 03/13/2001 03/13/2001 0 PUB PUB NONE NONE NONE 1
0168871 04/18/2001 PA 1.0 0 1 F 04/12/2001 Right arm at site of injection, red, inflammed and blister/vesicle. Zovirax ointment Rx given to use every 3 hours X 7 days. U 03/27/2001 04/10/2001 14 PVT PVT NONE Atrial Septal Defect 1
0168872 04/18/2001 MN 5.0 4 M 04/11/2001 Pt developed polymorphic morbilliform rash on upper torso, upper back and upper extremities where vaccines were given in 5 minutes. After a dose of Benadryl, rash faded away and pt was asymptomatic. Y 04/11/2001 04/11/2001 0 PVT PVT NONE 1
0168873 04/18/2001 MA 11.0 11 F 04/11/2001 Localized reaction at injection site with swelling, redness, warmth and nodule. This resolved without treatment in 5 days. Also, complained of stomachache, 2 days, post vax, which resolved in 2 days. Y 02/14/2001 02/15/2001 1 PUB PUB NONE NONE NONE 1
0168874 04/18/2001 MO 41.0 40 M 12/02/2000 Pt reported complaint of dry throat, dizziness, headache and muscle pain after receiving 2nd Hep-A vaccine. Pt complained "feels like my throat is closing". Pt given O2 2L NC, placed on C/A monitor-NSR, Benadryl given IM at injection site. Solu-Cortef IV X 1 and EKG. Transferred to ER. Y Y 09/18/1999 09/18/1999 0 C/A monitor NSR, EKG-negative MIL MIL NONE NONE NONE 1
0168875 04/18/2001 PA 5.0 5 M 04/11/2001 Redness, swelling in left thigh and down to knee. Small bruise around site. Y Y 04/03/2001 04/04/2001 1 PVT PVT NONE 1
0168876 04/18/2001 IL 10.0 10 F 04/11/2001 Mother called to report that child has a fever of 101F, abdominal cramping and vomiting. Referred to her MD. Y U 04/10/2001 04/11/2001 1 OTH OTH NONE NONE NONE 1
0168883 04/19/2001 NJ 56.0 56 M 04/09/2001 The pt experienced joint pain, shoulder, neck, lower back, waist, knees, ankles, hand and hips at all times. Per doc 215546, patient still have stiffness of all joints, including lower back pain and neck pain. Also, at times there is extreme pain in both wrists. Y N 01/15/2000 05/01/2000 107 PVT UNK Norvasc 5mg; Lotensin 10mg NONE High blood pressure 1
0168884 04/19/2001 MI 35.0 35 F 03/22/2001 On 3/22/01, client states soreness in left upper arm laterally since receiving TD on 1/29/01. Complained of discomfort with raising arm above shoulder level and when sleeping on it. Client had not mentioned this soreness to mother until today when she presented in clinic for #3 Hep-B. No other history of injury. Advised warm compresses. Mom does not plan to seek doctor's care. Y U 01/29/2001 01/31/2001 2 NONE PUB PUB NONE NONE NONE MI2001027 1
0168885 04/19/2001 WA 1.3 1 .3 M 12/19/2000 Following vaccination, the parents noticed flu like symptoms. A slow and progressive loss of weight, drop in weight percentile. We brought this to his physicians attention along with his tooth decay and it was dismissed as being overly concerned parents and the tooth decay was staining. Hospital Diagnoses: New onset IDDM and dehydration Y N 03/29/1999 09/03/1999 158 PVT PVT NONE NONE Diabetes Melitus~Vaccine not specified (no brand name)~~1.00~In Patient|~Pertussis (no brand name)~~0.20~In Sibling 1
0168886 04/19/2001 MI 1.08 1 .1 F 03/28/2001 Subsequent to receiving vax, pt became crabby, and experienced decreased appetite. One day post vax, the pt awakened with rash around hair line, neck, behind ears and on back. Small raised reddened rash remains on legs at the time of this report. U 03/27/2001 03/27/2001 0 PUB UNK born with cleft lip MI2001029 1
0168887 04/19/2001 MI 1.5 1 .6 F 03/15/2001 On 3/15/01, pt's mom phoned to state that the pt's right leg was swollen to twice it's normal size, from above the knee to the groin. No fever or complaint of pain while walking or playing. Mom is using Tylenol every 4 hours. Advised to continue with Tylenol and use cool compresses. Call MD if needed. On 3/16/01, telephone call to Mom and she states swelling is resolved and child playing. Y 03/14/2001 03/15/2001 1 NONE PUB PUB NONE NONE NONE MI2001028 1
0168888 04/19/2001 MN 2.0 2 .0 M 04/12/2001 Pt is not moving his right knee, post vax, 3 days ago. Mom states that he got the shot in the morning and then went on a 3 hour car ride. By the last hour of the car ride he was crying continuously and telling her that he had an owie. By the time they reached their destination, he was not bending the knee. He was hobbling on the leg and would not bend the knee at all. Wednesday evening on 4/4/01, he developed a fever to 103F and had fevers throughout most of the evening. He did break the fever in the early morning but then had a fever again yesterday. No vomiting. He has had some mild cough and cold symptoms. Mom called yesterday and was told to monitor his symptoms until today. She stated that very shortly after the vaccination, he developed a minimal splotchy red rash, about the size of a quarter, below the site. DX: decreased motion of the right knee, possible adverse reaction to pneumovax versus infection versus inflammation. I am going to contact orthopedics to see if they will be able to see him in the ER at this point. The family will be going to the ER immediately. Orthopedics determined this to be a hematoma. Follow-up phone call to mom on 4/11/01 and she stated he was back to normal by 4/10/01. Had slow improvement noted. Y Y 04/03/2001 04/03/2001 0 CBC on 4/3/01 and WBC was 4.4; hemoglobin-12.3; hematocrit 33.6% and platelets-266,000. CBC on 4/6/01 shows WBC of 7.2 and this is up from 4.4. His hemoglobin is 10.4, hematocrit is 29% and platelets are 301,000. A differential shows 49.9% lymphocytes and 45.7 neutrophils. X-rays of knees-no abnormalties. PVT PVT NONE NONE Hereditary Spherocytosis; allergy to Zithromax Fever, swollen leg and rash~Pneumo (Prevnar)~1~1.00~In Patient 1
0168889 04/19/2001 PA 0.2 0 .2 F 04/11/2001 Screaming episode. Y Y 02/06/2001 02/06/2001 0 PVT PVT NONE NONE 1
0168890 04/19/2001 IL 1.25 1 .3 M 04/12/2001 On 3/20/01 at 11:00 am the child received vaccines. At home at 5:00PM the pt had a febrile convulsion, with a temp of 102.1. Treated with Tylenol without improvement and then on 3/24/01 was diagnosed with RSV with treatment of antibiotic steroid and albuterol with a recovery in 7 days. Y Y 03/20/2001 03/20/2001 0 CBC, blood culture - both neg PUB PUB NONE NONE NONE 1
0168891 04/19/2001 CA 4.0 4 M 03/15/2001 The pt experienced mild facial, neck and chest rash. No shortness of breath, airway and lungs clear. Benadryl was given at onset, no other meds. The pt was discharged without symptoms except rash which remained mild. Mother given instructions on signs and symptoms. Y 03/15/2001 03/15/2001 0 NONE PVT UNK NONE NONE NONE 1
0168892 04/19/2001 MA 1.5 1 .5 M 04/12/2001 The pt experienced localized cellulitis to the left thigh. Treated with children's Motrin and advised to follow up the following day. Y Y 04/10/2001 04/11/2001 1 NONE PVT UNK NONE NONE NONE 1
0168893 04/19/2001 NE 1.0 1 .0 F 04/12/2001 Infant noted to have fever, became less responsive, had a period of apnea 10-15 seconds, felt to be very limp and unresponsive. Call 911 and taken to the hospital for observation. Y Y 04/09/2001 04/09/2001 0 None PVT PVT NONE 1
0168894 04/19/2001 IL 1.5 1 .6 M 04/13/2001 Developed a papular (sand paper) like rash on trunk, upper and lower extremities within 24 hours, post vax. Also had a low-grade temperature the day after vaccines. (+) cough; otherwise, normal exam. U 04/11/2001 04/12/2001 1 Throat culture for Strep PVT PUB NONE URI, cough, runny nose, afebrile 1
0168895 04/19/2001 MN 56.0 56 F 04/09/2001 I had full body aching as severe as I've ever had, with no other symptoms of the flu. This lasted 2 days. Y 11/24/2000 11/25/2000 1 PVT PVT NONE 1
0168896 04/19/2001 IL 1.0 1 .0 M 04/04/2001 Rash on body and low-grade temperature. Y Y 03/22/2001 04/02/2001 11 PVT PVT 1
0168897 04/19/2001 WI 3.0 1 .0 M 04/11/2001 Developed a mild case of chickenpox. Started on 4/1/01 with a fever, then a rash on 4/6/01. All Scabbed over by 4/9/01. Also had strep throat and was treated with Zithromax and Zyrtec. Y 08/28/1998 04/01/2001 947 Quick Strep test (+) Strep PVT PVT PPD/Connaught/245511/ID/LA/0 previously NONE NONE 1
0168898 04/19/2001 MN 18.0 18 F 04/12/2001 Expressed dizziness following shot. Nurse assisted her to lower head. Brief loss of consciousness (30-45 seconds) and awakened and color pale. BP 90/50-deep breathing done. Remained with head down 3-4 minutes. Felt less dizzy; took water and BP 104/58 and ambulated to waiting area. Supervised by parent. Dismissed 4:05 PM. Y 04/12/2001 04/12/2001 0 NONE PUB PUB NONE NONE History of fainting reported. 1
0168899 04/19/2001 CA 10.0 10 M 04/12/2001 Pt came to office on 4/7/01 complaining of right should pain and swelling. Dx'd with cellulitis. Treated with Keflex 500mg tid #30. Return to check-up appt. in 2 days. No show. Unable to contact. Y U 04/05/2001 OTH PUB 1
0168900 04/19/2001 OH 1.9 1 .9 F 04/05/2001 Within 1/2 hour, post vax, had diffuse urticaria followed by breathing difficulty. Treated with 6.25mg Diphenhydramine po; albuterol 0.5/2.5u NS Nebulizer; 7.5mg prednisone po; O2 via face mask. Took to children's medical center and observed X 2 hours. Y Y 04/05/2001 04/05/2001 0 PVT PVT NONE NONE Former 31 week; BPD (d/c O2 supp. X 3 weeks). NG feeds. 1
0168901 04/19/2001 KY 5.0 1 .9 M 04/12/2001 Chickenpox treated with Zovirax liquid. Y Y 07/22/1997 04/12/2001 1360 PVT PUB NONE NONE 1
0168902 04/19/2001 ID 1.0 1 .0 M Atypical measles rash, fever. Rash started on face and progressed throughout body. Still has some rash but is resolving. Y N 03/09/2001 03/20/2001 11 PVT UNK NONE Rash and fever NONE 1
0168903 04/19/2001 MI 27.0 27 F 03/19/2001 The pt experienced dizziness, felt like she was going to pass out, with a headache and nausea. Y 01/29/2001 01/29/2001 0 NONE PUB PVT NONE NONE asthma MI2001026 1
0168904 04/19/2001 IN 10.0 10 M 04/11/2001 Post vax, Hep-B #1, that evening, had fever to 102F, queasy and pale X 2 days. Also, upper arm had a painful knot. Not red or warm. Y 04/06/2001 04/06/2001 0 NONE PVT PVT None NONE NONE 1
0168905 04/19/2001 CA 1.25 1 .2 M 03/16/2001 At site of DTAP/IPV injection, pt with 7cm of induration and erythema. Y 03/15/2001 03/16/2001 1 NONE MIL MIL NONE NONE 1
0168906 04/19/2001 VA 20.0 21 F 04/12/2001 Complained of itching at and around injection site and 10 minutes, post vax, hives appeared around injection site and disappeared, 5 hours later. Benadryl was recommended but employee didn't take any since symptoms resolved. No other symptoms occurred. Y 04/11/2001 04/11/2001 0 PVT PVT NONE NONE Asthma, allergic to PCN and ASA. 1
0168907 04/19/2001 ID 1.25 F 04/12/2001 Atypical measles rash. Y PVT UNK 1
0168908 04/19/2001 SD 80.0 80 F 04/13/2001 Pt reported reaction at approx. 16:00 on 4/12/01. She had pain, edema, erythema and itching at left deltoid injection site. Area of edema measured and area of erythema measured. Benadryl 25mg given at 16:30 and 10 capsules of same for home administration. Y 04/12/2001 04/12/2001 0 NONE PVT OTH Claritin Reditabs Osteoporosis; Labile BP; Hyperglycemia; Diverticulosis; Thyroid replacement therapy history; Degenerative arthritis; Prostatic right hip 1
0168909 04/20/2001 F 04/12/2001 Information has been received from a male consumer concerning his wife who had a history of Hodgkin's Disease and a splenectomy. On an unspecified date, the patient was vaccinated with pneumococcal vaccine polyvalent. Subsequently, she developed pneumococcal disease. The patient died in approximately January 2001 due to pneumococcal disease. The consumer reported that his wife had not received the five year follow up vaccination with pneumococcal vaccine 23 polyvalent. No further info is available. Y N 01/01/2001 UNK UNK UNK Hodgkin's lymphoma, splenectomy. WAES01040902 1
0168914 04/20/2001 FL M 04/12/2001 Information has been received from a medical assistant and medical records concerning a non-smoking male patient with no known allergies and history of prior transurethral resection of the prostate, a left inguinal hernia repair, tonsillectomy, and adenoidectomy who on 03/09/00 was vaccinated with Pneumococcal vaccine 23 polyvalent. Concomitant therapy included Bisoprolol (+) hydrochlorothiazide (ZIAC). On 03/10/00, the patient presented to a walk in clinic because he experienced a reaction on the arm of the injection which was described as a reddened area involving the upper arm on down to the elbow (also described by the medical assistant as being swollen). The patient was not admitted to the hospital but was given a shot of Rocephin and advised to take Benadryl. That night, the patient took on dose of Benadryl and the following morning he again presented to the walk in clinic because he had increasing redness, but no fever or shortness of breath. A white blood cell count was drawn at the clinic and the result was within nml range. The patient was the referred to the ER for evaluation. A physical exam revealed a well nourished, well developed male with a normal physical exam exam except for marked erythema of the lateral aspect of the right upper arm down the elbow. The area was not indurated or tender to palpitation. The patient's temp was 97.2 and a pulse ox was 97%, showing no evidence of hypoxia. The patient was placed on therapy with prednisone. He was advised to use moist heat on his arm, and to follow up with his physician within two to eight days, or with the walk in clinic. On 04/02/01, the medical assistant reported that the patient's experience was "an allergic reaction" and he was noted to be "fine". It was also noted that the patient had received Pneumococcal vaccine once before and did not have a reaction. Upon internal review, allergic reaction was considered an Other Important Medical Event. Additional info is not expected. The reporter also provided info regarding the experience of the patient's wife following vaccination with Pneumococcal vaccine polyvalent. Additional info has been requested. Addt'l info received states this was an allergic reaction, pt now fine. Y Y 03/09/2001 03/10/2001 1 WBC 03/11/01 - Wnl. OTH OTH Ziac Adenoidectomy, surgery, tonsillectomy, transurethral prostatectomy WAES01031442 1
0168918 04/20/2001 F 04/16/2001 Information has been received from a lawyer concerning a female who was vaccinated with Hep-B vaccine recombinant (yeast). Subsequently, the pt experienced hepatitis C which "caused chronic fatigue and fibromyalgia". According to the lawyer, she also had an anaphylactoid type of reaction "from the vaccine" followed by optic neuritis and "other evidence of" demyelinizing disease. Upon internal review, Hepatitis C, anaphylactoid type of reaction, optic neuritis and demyelinizing disease were considered to be "Other Important Medical Events". No further information is available. U UNK UNK UNK UNK WAES01040912 1
0168920 04/20/2001 FL F 04/16/2001 Information has been received from an MA concerning a non-smoking female pt with no allergies and a history of cataract surgery and hysterectomy who on 3/9/00 was vaccinated with pneumococcal vaccine 23 polyvalent. Shortly following vaccination, the pt's arm, where she received the injection, swelled and turned red. On 3/10/00, the pt presented to a walk-in clinic. The pt was not admitted to the hospital but was evaluated at the walk-in clinic and treated with Rocephin and instructed to take Benadryl. That night, the pt took 1 dose of Benadryl and on the following morning, she presented to the clinic again because her arm was worse. A WBC count was normal. The pt was referred to the ER for evaluation. A physical exam showed an afebrile, well developed, well nourished female and all review of systems were negative except for a redness of the left upper arm down almost to the elbow. There was no induration or tenderness and the area was slightly warm to touch. The medical records indicated that the impression was an: "allergic reaction to pneumococcal vaccine 23 polyvalent." The pt was prescribed prednisone 40mg per day for 4 days, 20mg per day for 4 days and 10mg per day for 4 days. She was advised to follow-up with the walk-in clinic or her physician within 2 to 8 days. On 4/2/01, the MA noted that the pt was "fine". It was also noted that the pt had never received pneumococcal vaccine 23 polyvalent before. Upon internal review, it was determined that the pt's allergic reaction was an "Other Important Medical Event". Additional information is not expected. The reporter also provided information regarding the experience of the pt's husband, following the same vaccine vaccination; (see WAES 01031442). Y Y 03/09/2001 03/10/2001 1 WBC count-nml on 3/10/01 OTH OTH (therapy unspecified) Cataract removal; hysterectomy WAES01032408 1
0168921 04/20/2001 TX 0.2 0 .2 F 04/16/2001 Information has been received concerning a 14 week old female with no medical history of illnesses or fevers who on 1/17/01, was vaccinated with the 1st dose of haemophilus b conjugate vaccine + hepatitis b vaccine recombinant (yeast). Concomitant therapy included the 1st dose of streptococcus pneumoniae vaccine (Prevnar) IM, the 1st dose diphtheria toxoid/pertussis/tetanus vaccine (Acel-Imune), and the 1st dose poliovirus vaccine. On 2/20/01, the pt experienced a seizure and fever of 103F. She was taken to ER. The seizure was considered a "Significant Medical Event". Follow-up was received from a healthcare professional. She was treated at the ER with Rocephin. An LP was offered but was refused by the parents. The pt was discharged from the ER. On 2/21/01, the pt was seen for follow-up in the pediatrician's office. She was given Rocephin 700mg again. On 2/22/01, the pt was in the pediatrician's office for another follow-up visit and it was documented that the pt was "alert, active and doing great". The CBC came back with elevated WBC's. The pt's ears were red, and the final dx was a urinary tract infection. The last visit for the pt was 3/14/01, at which time she received her 2nd dose of haemophilus b conjugate vaccine + hepatitis b vaccine recombinant (yeast). The decision was made to not give the pt a 2nd dose of Streptococcus pneumoniae vaccine (Prevnar). No further information is available. This was originally reported by a physician. Y U 01/17/2001 02/20/2001 34 Blood culture-nml, no growth on 2/20/01; CBC-elevated WBC's on 2/20/01 UNK UNK UNK WAES01040237 1
0168926 04/20/2001 CT 40.0 39 F 04/15/2001 Beginning July 1999, symptoms mimicking rheumatoid arthritis in some ways have been persistently present. Debilitating pain and inflammation in knees is primary symptom, but there has also been chronic fatigue, and other arthralgia. This is not RA, and Sjogren's has also been ruled out. Follow-up information per pt, "Ongoing auto-immune arthritis symptoms. Still unresolved diagnosis or treatement plan as of 7/01/01. Y Y N 02/01/1995 07/12/1999 1622 PVT OTH NONE NONE NONE 1
0168927 04/20/2001 0.5 U 04/18/2001 Information has been received from an investigator concerning a child who received a 1st dose of Prevnar as a part of a trial. On 06/27/00, the child was taken to a local clinic after waking from a nap with a red face, rubbing eyes that were closed. A diagnosis of possible seizure was made. The events were considered medically important. As of the date of this report, the investigator and the medical monitor assessments were unknown. Follow up information received on 04/19/2001 from the study investigator revealed the events were "outside the reportable window" and therefore, not related. A follow up report received 12/03/2001 adds: Seen 07/05/2000 for follow-up to an ER visit on 6/27/00 for possible seizure. "Pt woke up from nap, seen rubbing eye, face red, eye closed. Dx'd possible seizure." Child born at 40 3/7 weeks (by dates). On day of discharge=breast fed well, good urinary output, passing stools, birth weight 8lbs 5oz. Exam of head at this time overlapping sutures, noggizal and coronal, very small anterior fontanel, only fingertip in size. Discharge note indicates pt to be observed closely for head circumference and resolution of overlapping sutures, otherwise, rule out craniosynostosis. 1/17/00 negative skull X-ray for premature synostosis. 6/26/00 11AM seen in ER (registered 6/27/00) for "At 2230 child rubbed his eyes then he appeared to pass out (mother) yelled and shook him and he gasp(ed) for air. Had just awakened ..ago." Review of symptoms: Temp 97 at ER. Pulse 124, Resp 28, O2 Sat 98%. Tugging at ears. TM's red, neck supple. "Gasped for air 2 wks ago." Neg for nausea/vomiting/diarrhea. Neg for hx of seizures. Eating well. Dx at this visit Acute altered level of consciousness-possible seizure. Acute OM. 7/5/00 seen for f/u in clinic. States: ER f/u seen 6/27/00. Just woke up from nap, seen rubbing eye, face red, eye closed slowly, fell forward, seemed alert afterward. No hx of seizure in family. Hx of ingestion. Negative CT and labs by report; no fever but said to have OM in ED, given shot. Well appearing at this time. Assessed ? seizure. 7/10/00 EEC done: Tracing within normal limits in the brief interpretable periods of the tracing, and a repeat tracing should be considered if the child's spells recur. Child has more visits, all without recurrence of above event or similar. 8/3/00 mentions normal EEG above without discussion of seizure like events. 11/24/00 well care, normal exam. 2/26/01 well care, recent OM otherwise normal exam. 9/20/01 well care, normal exam, normal development. U 06/27/2000 NONE UNK UNK UNK UNK HQ9760717APR2001 1
0168928 04/20/2001 UT 2.0 1 .5 M 04/18/2001 A mother reported that her son received Orimune, Tripedia and MMR vaccines on 7/21/95 at the age of 30 months. He also received Tetanus in 1994 at approximately 18 months of age. the mother reported that after her son's final series of vaccinations at the age of 18 months he developed autism. On either 7/24/95 or 7/26/95 he developed a fever of approximately 105. Since that time, his mother watched him lose language skills and interest in interacting with other children. He was reportedly officially diagnosed with autism at 3 years old. Autism is considered "medically important". Follow-up states that the pt also developed gastrointestinal problems. Information received on follow-up also indicated that the event resulted in permanent disability. The pt also received tetanus toxoid adsorbed purogenated (IM) in 1994 apt approx. 18 months of age. Aditional information has been requested. Y Y N 07/21/1994 07/26/1995 370 UNK PVT PVT NONE NONE UNK HQ9715416APR2001 1
0168929 04/20/2001 PA 8.0 8 F 04/16/2001 This child had Swelling, and redness of the left arm. U 04/10/2001 04/12/2001 2 NONE PVT PVT Zyrtec, Proventil, Provera, Pulmacort. NONE Allergies, Asthma. 1
0168930 04/20/2001 IA 3.0 3 F 04/05/2001 This child had a local reaction a the site of injection;right deltoid. Edema and redness to the elbow. On the 2nd evening, delayed hives. She was given Benadryl for the hives. N 04/03/2001 04/04/2001 1 NONE PUB PUB NONE NONE 1
0168931 04/20/2001 MN 0.3 0 .2 M 04/13/2001 The parents of this patient related that the patient had a 3 day history of fever, fussiness, local red, warm, tenderness, and high pitched crying. Question shuddering behavior vs seizure-like activity. Y 02/09/2001 02/10/2001 1 NONE PVT PVT NONE NONE NONE 1
0168932 04/20/2001 AZ 1.0 1 .0 F 04/12/2001 This infant was unresponsive within less than 2 minutes, followed by tonic clonic seizures, vomiting. Oxygen was applied, 911 called to the ER. Y Y 04/11/2001 04/11/2001 0 NONE PUB UNK NONE Slight otitis media. NONE AZ0111 1
0168933 04/20/2001 NY 1.9 2 .9 M 04/17/2001 A mother states after an hour she left the clinic, the child started to vomit and it was persistent. She went home and called the clinic. The child returned to the clinic, was evaluated and referred to the ER for further observation. Discharged from the ER on the same day. Y 04/17/2001 04/17/2001 0 PUB OTH PPD Well child NONE 1
0168934 04/20/2001 NJ 41.0 41 F 04/17/2001 Report 2001009563-1 described numb fingers (right hand) in a 41 year old female who received Lyme disease vaccine recombinant OspA (Lymerix) for the prevention of Lyme Disease. This report was received from the vaccinee and has not been verified by a physician or other health care professional. The vaccinee has seasonal allergies. Her medical history included crushed vertebrae (cervical spine). She took Hydrocodone and Zolpidem Hemitartrate (Ambien) prn. On 04/13/01, the vaccinee received her first left deltoid dose of Lymerix, twenty minutes post-vaccination, she experienced fever, chills, numb fingers (right hand), and weakness. As of 04/13/01, the outcome of the events was resolved. The adverse event of "numb fingers" does not meet ICM serious criteria, but is being submitted as an expedited report by special FDA request per the June 28, 2000 letter. Follow up states the patient also experienced a headache and light headedness. Y 04/13/2001 04/13/2001 0 OTH OTH Hydrocodone, Ambien (Zolpidem Hemitartrate) Crushed vertebrae (cervical spine), Seasonal allergies. 20010095631 1
0168935 04/20/2001 MD 35 U The patient noticed last night around 10 PM, his arm was very sore and itching. The patient pulled up his sleeve, there was a huge red circular swelling, and the area was very hot. At 2 PM the following day and it was still red, hot, and swollen. N 04/18/2001 04/19/2001 1 PVT PVT NONE NONE NONE 1
0168936 04/20/2001 CA 3.0 1 .1 F 04/13/2001 This child had varicella zoster on the left hand and forearm. Y Y 09/16/1998 07/18/2000 671 Positive Varicella DFA PVT UNK NONE NONE NONE 1
0168937 04/20/2001 KS 1.0 2 .1 F 04/12/2001 This child has a rapidly enlarging erythematous induration, tender, and firm on the left thigh, 10 x 9 cm. U 04/11/2001 04/11/2001 0 OTH UNK NONE NONE 1
0168938 04/20/2001 CA 2.0 1 .3 M 04/12/2001 No data N 04/12/2001 PVT UNK 1
0168939 04/20/2001 SC 1.0 1 .0 M 04/12/2001 This infant was vaccinated on 03/19/01 with Varicella. The patient's mother called the primary care physician on 03/21/01, with complaints of hive like rash all over his body. The mother treated with Benadryl and Calamine lotion. Some question of whether moms allergy to Neomycin carried over to the child. Y Y 03/19/2001 03/21/2001 2 NONE MIL MIL 03/16/01 Viral enteritis with dehydration. Atopic dermatitis. 1
0168940 04/20/2001 GA 5.0 0 1 F 04/12/2001 This child had scattered vesicular lesions with red base, a few on the trunk, less than 20 lesions. Brea through varicella / had vaccine. Y 02/25/1997 04/10/2001 1505 NONE PVT PVT NONE NONE 1
0168941 04/20/2001 IL 1.5 1 .5 M 04/13/2001 This infant had DTaP given 03/29/01. 10 x 8 cm local reaction, redness, and induration on the leg leg. Y 03/29/2001 03/30/2001 1 NONE PVT PVT NONE NONE 1
0168942 04/20/2001 DC 11.0 11 F 04/14/2001 HBV & VZV given at 2 PM on 04/12/2001. In the AM of 04/13/01, the patient had swelling, erythema, and bullae noted on the right triceps, site of VZV vaccine. Area appears cellulitis. Y U 04/12/2001 04/13/2001 1 NONE OTH PUB NONE NONE HbSS (Sickle Cell Anemia). 1
0168943 04/20/2001 CA 6.0 6 M 04/14/2001 3 hours after the patient was given his Hepatitis A vaccine he started running a fever. The fever lasted on and off for 3 days. The highest the fever got was 104. He was given Motrin and Tylenol which did not keep the fever down. Y 04/03/2001 04/03/2001 0 PVT UNK NONE NONER Slight allergy to milk (cows). 1
0168944 04/20/2001 OR 1.0 1 .0 F 04/06/2001 This infant has onset of vomiting lasting about 12 hours, followed by diarrhea. Inset within 4 hours of vaccines. Y N 04/05/2001 04/05/2001 0 NONE PVT PVT NONE NONE NONE 1
0168945 04/20/2001 AZ 14.0 14 M 04/05/2001 Two days after injections, this client developed raised, red, nickle size, bumps on both legs, groin and buttocks areas and chest. Went away over night and then reappeared the next evening only on the legs. The father is a doctor who cared for the client. N 03/07/2001 03/09/2001 2 NONE PUB PUB NONE NONE AZ0110 1
0168946 04/20/2001 ME 5.0 5 M 04/18/2001 The pt experienced a fever of 101, pain in rib cage and chest area. Y 04/11/2001 04/11/2001 0 PVT PUB NONE NONE ME01011 1
0168947 04/20/2001 MN 58.0 58 F 04/13/2001 The pt experienced a 4"x3" area of redness and warmth at the injection site. The doctor prescribed cold compress, and Tylenol for discomfort and Allegra (antihistamine) as needed. Y U 04/09/2001 04/12/2001 3 NONE PUB PVT Premarin NONE allergy to Sulfa 1
0168948 04/23/2001 TX 4.0 4 M 04/06/2001 Redness and swelling on lower left arm; redness the size of an orange. Child states it doesn't hurt and he feels good. Y 04/05/2001 04/06/2001 1 NONE PUB PUB NONE NONE NONE 1
0168949 04/23/2001 WA 0.2 0 .2 M 04/09/2001 Pt presents with swollen area of left thigh 35cm X 40cm in size at 16:00. Mom complained that pt has cried since receiving injection at 11:30. Area has no redness or heat. Mom calls on 4/9/01 and states that pt is better. Y 04/08/2001 04/08/2001 0 PVT PUB NONE NONE NONE 1
0168950 04/23/2001 FL 3.0 3 F 04/12/2001 Developed erythematous, pruritic rash over body. Y Y 04/10/2001 04/11/2001 1 PVT PUB NONE URI, Bilateral conjunctivitis NONE 1
0168951 04/23/2001 FL 0.4 0 .4 F 03/27/2001 3 days, post vax, pt developed hives and whelps all over body. Neck and chest splotchy, macular erythema. No other complications. U 03/20/2001 03/27/2001 7 PVT PVT 1
0168952 04/23/2001 FL 0.75 0 .5 M 04/16/2001 The pt experienced a rash all over his body. Treated with Benadryl. Y 01/16/2001 01/22/2001 6 PVT PUB 1
0168953 04/23/2001 MS 0.5 0 .5 M 04/17/2001 Developed whelps following immunizations. Administered po Benadryl. Y 04/16/2001 04/16/2001 0 NONE PVT PUB NONE NONE 1
0168954 04/23/2001 WI 1.5 1 .5 F 04/16/2001 Left thigh cellulitis treated with Keflex 250mg X 10 days; ice prn; Tylenol/Advil prn. Shot given on 4/13/01 and seen for cellulitis on 4/14/01. Quarter-sized red and warm area at injection site. Y Y 04/13/2001 04/14/2001 1 NONE PVT PVT Biaxin finished on 4/12/01 NONE Allergy to Amoxicillin 1
0168955 04/23/2001 OH 1.0 1 .0 M 04/17/2001 Approx. 10 days, post vax, pt had generalized t/c seizure about 20 minutes and fever to 39C (rectally). Also had rash consistent with chickenpox. Y Y 04/06/2001 04/16/2001 10 Blood Glucose 131 PVT PVT NONE NONE NONE 1
0168956 04/23/2001 GA 5.0 1 .5 M 04/28/2001 Child new pt to this practice, came in for symptoms of rash. Has 15-20 chickenpox lesions on trunk and face. Apparently had vaccine at Pediatrician, elsewhere. We only have dates transferred. Child is doing well and expect full recovery. Y Y 12/02/1996 04/19/2001 1599 NONE PVT PVT 1
0168957 04/23/2001 OH 0.3 0 .2 F 04/14/2001 Prolonged screaming over 4 hours. Temperature maximum of 100.9F. Y 04/11/2001 04/11/2001 0 NONE PVT PVT NONE Viral URI NONE 1
0168958 04/23/2001 TX 15.0 15 M 04/16/2001 1-2 minutes, post vax, and walking around, pt fell to the floor. BP 132/84; P 100; R 24. Laceration to tongue and lower lip and about 1" laceration above right ear. Has a history of seizures. Sweating profusely and ice was applied to lip and ear. Pt did lose consciousness of 1-2 minutes. Y Y 04/16/2001 04/16/2001 0 PUB OTH NONE Allergies; Holter monitor for irregular heart beat 1
0168959 04/23/2001 NC 1.25 1 .3 M 04/06/2001 Localized redness, approx. 6cm in diameter area, warm to touch and toddler noted to scratch. Advised warm compresses and Tylenol every 4 hours, follow-up with our office if symptoms persist or worsen. U 04/04/2001 04/05/2001 1 PVT PUB NC01043 1
0168960 04/23/2001 MD 4.0 4 F 04/18/2001 Within 12 hours, post vax, developed fever to 103F-104F without other symptoms. About 30 hours, post vax, developed very large area of redness and swelling of left upper arm. Fever resolved within 24 hours. Y 04/14/2001 04/15/2001 1 NONE PVT UNK NONE NONE 1
0168961 04/23/2001 MD 4.0 4 F 04/18/2001 On 4/15/01, post vax, pt developed ecchymosis at injection site with a very large area "whole upper arm" red, swollen and "hot to touch". Y 04/14/2001 04/15/2001 1 NONE PVT PVT NONE NONE NONE 1
0168962 04/23/2001 GA 46.0 46 F 04/16/2001 At 14:45, felt as if heart was in throat. Pulse "felt-racing", dizziness and vital signs were slightly increased. 12 hours later, had nausea, vomiting and headache. Y 04/16/2001 04/16/2001 0 Vital signs-slightly increased MIL MIL PPD/Parkdale/00980P/LFA/1 previously NONE Allergies to meds and food 1
0168963 04/23/2001 FL 5.0 1 .0 M 04/13/2001 20-30 papular vesicular lesions, onset 4/12/01. Afebrile. On 4/16/01, had total of 120 lesions. Y 07/01/1996 04/12/2001 1746 NONE PVT PVT NONE NONE 1
0168964 04/23/2001 MI 1.0 1 .1 F 04/06/2001 On 4/6/01, call from mom stating child had a fever of 106F (axillary) this AM. Notified nurse to return call. Tylenol and Motrin were given with good outcome. Temperature was down to 99F. During the day child was "tired". Fever went up again during the night to 103F Took child to ER on 4/7/01. Dx'd with bilateral otitis media. On different medication now and is doing well without temperature. Y Y 04/05/2001 04/06/2001 1 PUB PUB IPV/Connaught/T0472/SC/RL/2 previously; Augmentin X 1 week for ear infection Had ear infection 1 week prior NONE 1
0168965 04/23/2001 PA 4.0 4 F 04/17/2001 Swelling and redness of left arm from shoulder to wrist. Y 04/16/2001 04/17/2001 1 PUB PUB NONE NONE NONE 1
0168966 04/23/2001 CA 1.5 1 .5 M 04/16/2001 Left leg from thigh to knee, swollen with slight redness at medial aspect. None at injection site but increased heat. Some tenderness to touch. U 04/13/2001 04/14/2001 1 PVT PVT NONE 1
0168967 04/23/2001 TX 48.0 48 F 04/16/2001 The pt experienced a 5 x 4 inch area around the injection site which became red, swollen, and painful about 9 hours after injection. The pain also involved top of shoulder and side of neck. Pain, redness and swelling lasted 4 days. Slight temp elevation onset 11 hours post vax lasting one day and was relieved by Tylenol. Y 04/09/2001 04/09/2001 0 NONE OTH PUB PPD/Merieux/C0153AA/ID/LA NONE NONE 1
0168968 04/23/2001 NY 8.0 8 M 04/12/2001 The pt experienced warm, erythematous, swelling and tenderness to the left deltoid injection site. Treated with cold compresses, and Motrin. U 04/10/2001 04/11/2001 1 PVT PUB NONE 1
0168969 04/23/2001 NC 6.0 6 M 04/06/2001 The pt was given Motrin at 2:30pm and then received vaccines at 3:30pm. The mother gave more Motrin at 8:00pm. At 2:00am he yelled and she found him standing, cold with his eyes rolled back. The pt was taken to the hospital by ambulance. Na+ level was checked. Neurologist was called. The child continues to be afebrile. Seizures in past occurred with fever. Y Y 04/05/2001 04/06/2001 1 Na+ level - wnl (per mother) PUB PUB Trileptol, Atanol, Respiridol recent sinus infection partial complex epilepsy, developmental delay and behavior disorder seizure~DTP + Hib (Tetramune)~4~1.00~In Patient NC01044 1
0168972 04/24/2001 CA 0.25 0 .2 M 03/08/2001 On 2/26/01 (2 weeks after immunizations), pt started having a fever of 100.8F and later increased to 103F with no relief with Tylenol. Pt went to see PMD and was admitted to the hospital on 2/27/01. On 2/28/01, he was dx'd with H. Influenza infection. Pt was discharged home on 3/5/01 with Augmentin X 5 days. Follow-up on 3/9/01 with PMD. Y 7 Y 02/13/2001 02/26/2001 13 Blood drawn on 2/26/01 at the hospital-detected haemophilus influenza PVT PVT vitamins NONE NONE 1
0168973 04/24/2001 MA 0.3 0 .4 F 04/06/2001 A few minutes after her vaccination, the infant became nonresponsive with blank stares, initially was limp with pallor, she cried intermittently with sensation, oxygen given. Episode lasted about 45 minutes with infant lethargic. After episode infant was alert and smiling. Y 1 Y 04/04/2001 04/04/2001 0 CBC; CSF; CT Scan; Electrolytes-all wnl; EEG-pending PVT PUB URI 35 5/7 weeks gestation, 1st of twins. 1
0168974 04/24/2001 KY 1.7 1 .7 F 03/29/2001 Approx. 11 hours, post vax, pt awoke with fever, vomited and was unresponsive X 20 minutes. Taken to ER by EMS. Discharged to home without further incident while in the hospital. Have been unable to reach at home. Diagnosed with seizure. Y Y 1 Y 03/27/2001 03/28/2001 1 X-Ray chest-wnl; Complete metabolic panel-NA, CO2 and Creat low; SGOT; SGPT decreased and Alka Phos elevated; WBC-17.8; UA PUB PUB NONE NONE NONE KY2001027 1
0168976 04/24/2001 IA 0.3 0 .3 F 04/06/2001 Pt became listless, crying, hypotonic, poor appetite and nystagmus. These symptoms were noted after her 4 month immunizations. She was seen by her physician at 5 1/2 months and noted she had no visual tracking. Referred to other physician and dx'd as legally blind. Other symptoms not addressed. Physicians felt she would grow out of the hypotonia and listlessness. The pt has had extensive workup so far for developmental delay and without any definite etiology being identified. A review of her course in infancy indicates that she had a normal head circumference at birth but thereafter, there was progressive decline in the head circumference after 6 months. She cannot even use her hands to feed herself finger foods (apraxia); is unable to walk without support and there is a tendency for repeated teeth grinding. I feel that the history of autistic features developing in association with regression in head growth as well as the associated hand wringing gestures and poor weight gain are highly suggestive of the Rett Syndrome. She is receiving speech therapy and she now walks with a platform walker. She has significant developmental delay/mental retardation of undetermined etiology. The 60 day follow-up states low tone, listless, developmental delay. Y Y N 10/16/1995 MRI x 2 - Neg. Genetic testing - Neg. Multiple labs and x-rays. ERG x 2 - low conest rods (poor test). PVT PVT Camitor started on 10/13/00 NONE NONE LISTLESS, CRYING.~DTP + IPV + Act-Hib (no brand name)~2~0.00~In Patient 1
0168977 04/24/2001 OH 0.3 0 .3 F 03/14/2001 Febrile seizure within 24 hours, post vax. Also with a 2 hour history of clear rhinorrhea prior to seizure. WBC of >25,000. Hospitalized for observation and IV antibiotics. The 60 day follow-up states that the pt's final diagnosis is febrile seizure. Pt received additonal doses of all vaccines on 06/04/2001 since any any adverse event. Notes- great aunt notes that child, dad and sib all have large heads but MD's are not concernred. Dx with febrile seizures Y Y 03/13/2001 03/14/2001 1 WBC of > 25,000; Blood/Urine; CSF culture-(P) PUB PUB NONE Early viral infection (?) NONE 1
0168978 04/24/2001 AZ 0.5 0 .5 F 03/16/2001 Pt slept for 3 hours, post vax, and woke up with a fever of 102F and vomiting when she woke up and had choking, difficulty breathing. Lips and face turned white. Took to hospital ER. Advised it was a possible reaction to a vaccination and to call PCP. The doctor in the office stated it was a definite reaction to pneumococcal vaccine. Y Y Y 03/15/2001 03/15/2001 0 NONE PVT PVT NONE NONE NONE 1
0168979 04/24/2001 CA 1.0 1 .0 M 02/27/2001 Mom noted rash at site of injections, left thigh, per phone call. Seen at another facility on 2/25/01. Y Y 02/09/2001 02/23/2001 14 UNK PUB PUB NONE NONE Deceleration of head growth and breath-holding tantrums 1
0168980 04/24/2001 TX 1.3 1 .4 M 02/23/2001 Mother called stating child had hives 1-1 1/2 hours, post vax. Treated with Benadryl. Subsided by the next AM. Not seen by physician. Y 02/12/2001 02/12/2001 0 NONE PVT PVT NONE NONE 1
0168981 04/24/2001 CA 2.0 2 .0 F Itchy rash below vaccine site. Rx desonide. U 02/28/2001 03/02/2001 2 NONE UNK UNK NONE 1
0168982 04/24/2001 RI 1.08 0 .2 F 03/26/2001 Pt cried, turned blue, developed cyanotic colored rash on thighs and then turned limp. Afterwards, had vesicular papular rash and was very dazed and sleepy. Symptoms resolved in 24-36 hours. Y Y 01/30/2001 01/30/2001 0 NONE PUB PUB NONE 1
0168983 04/24/2001 MA 0.75 0 .9 F 04/11/2001 Localized reaction with induration at site of injection. Diffuse papular rash over back, thighs and chest. Rash started, 2 days, post vax. No treatment. U 04/09/2001 04/11/2001 2 NONE PVT PUB NONE Viral illness Congenital deafness 1
0168984 04/24/2001 IN 1.25 1 .3 M 04/06/2001 Pt had received vaccines and 10 minutes, post vax, as family was leaving clinic, they returned because pt became red with hive-like blotches on face, neck and back of arms. No respiratory distress. Doctor was notified and ordered Benadryl and cool compresses. 24 hours later there were no hives. Y 04/04/2001 04/04/2001 0 NONE PUB PUB NONE NONE NONE 1
0168985 04/24/2001 MN 0.2 0 .2 F 02/22/2001 This patient developed hives after 2 month shots. Got Prevnar, DTaP, IPV, and HIB. She also had a stuffy nose for 2 weeks. Y U 02/20/2001 02/21/2001 1 PVT PVT URI 1
0168986 04/24/2001 KS 0.2 0 .2 F 02/23/2001 11:00 mom brought child for immunizations. She was given vaccines and waited 15 minutes without reactions noted. Pt left town with mom for vacation X 1 month. Not able to contact mom due to her being out of town but grandma contacted on 2/23/01 and she has no way to contact daughter. U 02/20/2001 02/20/2001 0 PVT PUB NONE NONE 1
0168987 04/24/2001 NJ 46.0 F 02/20/2001 A report 2001009913-1 described tingling and loss of feeling (hands and feet) in a female of unspecified age who received Lyme disease vaccine recombinant OspA (Lymerix). Allergies, medical history, and concomitant medications were unspecified. On an unspecified date, the vaccinee received her second dose of Lymerix. Subsequently, she experienced "severe" tingling in her fingers and toes which lasted for several months. Because her general physician could not pinpoint the problem, he sent her to a neurologist who came to the conclusion that "the Lymerix shots caused minor loss of feeling in (her) hands and feet." The tingling resolved after "several months". the adverse events of "tingling" and "loss of feeling" do not meet ICH serious criteria, but are being submitted as an expedited report by special FDA request per the June 28, 2000 letter. Y U OTH OTH 20010099131 1
0168988 04/24/2001 FL 76.0 76 M 03/20/2001 Pt broke out in a rash on 12/21/00. Started on ankle area and then spread to rest of body. Rash is red, itchy, flat, and round areas, sometimes ooze. Clears some and then returns. Went to MD and then referred to dermatologist and may see allergist. Still has rash. Y N 12/13/2000 12/21/2000 8 Biopsies-neg PUB PUB Lopressor 1
0168989 04/24/2001 PR 49.0 49 F 02/22/2001 Noted around injection site; redness, erythema, inflammation and general weakness. N 02/13/2001 02/13/2001 0 NONE PUB PUB Vasotec NONE Hypertension 1
0168990 04/24/2001 MO 5.0 5 M 04/18/2001 Right upper arm is swollen and redness and states it feels numb on 4/17/01 at 10:55 PM. Treated with Zithromax, Atarax and follow-up with MD. Y Y 04/16/2001 04/17/2001 1 NONE PVT PVT NONE NONE 1
0168991 04/24/2001 MO 5.0 5 M 04/21/2001 Right arm with redness and swelling, headache and stomachache and fever of 101F. Nauseated and with congestion. Y Y 04/18/2001 04/20/2001 2 PVT PVT Advil NONE 1
0168992 04/24/2001 NE 5.0 5 M 01/03/2001 Fever, upset stomach, swelling of arm at injection site. Came to ER. Y U 07/01/2000 07/02/2000 1 OTH OTH NONE 1
0168993 04/24/2001 SC 4.08 4 F 04/20/2001 Cellulitis of left leg (thigh). Treatment: antibiotics. Redness on thigh started the day after shots. Still being treated. Y U 04/18/2001 04/19/2001 1 PVT PVT NONE NONE 1
0168994 04/24/2001 AZ 18.0 18 F 04/06/2001 Pt states on 4/4/01 at 8-9 PM, noticed hives on arms. By 4/5/01 AM, pt awoke with hives over entire body. Went to ER and was given cortisone injection. Pt states all joints were swollen. Given po Zyrtec and prednisone. Pt states that on 3/27/01, went to PCP with sore throat and fluid in ears. Given generic amoxicillin and guaifenesin. Y Y 04/03/2001 04/04/2001 1 PUB PUB Amoxicillin X 11 days and quaifenesin Sore throat NONE AZ0113 1
0168995 04/24/2001 AZ 14.0 14 M 04/13/2001 Temperature 102.9F, within 24 hours, post vax, lasting 6-8 hours. Y 04/10/2001 04/11/2001 1 NONE PUB PUB NONE NONE NONE AZ0112 1
0168996 04/24/2001 IN 4.0 4 M 02/23/2001 On 1/15/01, child had slight cough. On 1/16/01, lips blue and difficulty breathing and mother gave albuterol and Benadryl that she had at home from previous asthma events. Stated has a history of asthma since 18 months old. Child then developed hives on 1/18/01 and has had hives almost daily since then. MD called 2-3 weeks later to renew meds. The doctor's office told the mother that she needed to be seen at that time so she took the child to the doctor on 2/12/01. The child had a rash on his groin and buttocks area at that time. The mother stated that the child continued to have allergy related events and was having hives almost daily. She stated that since the MMR was given, her son seems to have more allergies now. She was referred to an allergy specialist who will be doing some allergy testing on 2/26/01. The mother stated the child was dx'd with an egg allergy when he was about 18 months old but did not test positive for any other allergies at that time. The mother was told to call PCHD and let us know if the child tested positive for other allergies. N 01/11/2001 01/15/2001 4 NONE PUB PUB NONE Allergy to eggs; premature birth and was on ventilator for 3 months 1
0168997 04/24/2001 CA 36.0 37 F 02/15/2001 Developed case of Rubella after receiving MMR on 2/2/01, due to negative titer. U 02/02/2001 02/14/2001 12 OTH OTH NONE NONE NONE 1
0168998 04/24/2001 MI 45.0 45 F 03/19/2001 Approx. 2 hours, post vax, sweats, chills, nausea. Developed hyperglycemia (pt is diabetic). In 2 days, pain through upper arm and in 3 days, noted erythema and pain at injection site. N 03/15/2001 03/15/2001 0 NONE PVT PVT Lipitor, Synthroid, Premarin; HCTZ; Prilosec; Insulin NONE Type II DM; Hyperlipidemia; Hypothyroidism. 1
0168999 04/24/2001 OR 3.0 3 F 03/30/2001 Received 5 immunizations on 3/27/01. Left thigh with erythema 8cm X 10cm diameter at injection site. Y 03/27/2001 03/28/2001 1 NONE PVT PUB NONE NONE 1
0169000 04/24/2001 CA 1.0 0 .0 M 03/15/2001 Developed fever of 104.5F (ax) 24 hours, post vax. Addendum: Child had temperature of 103.3F, post vax, and we gave Motrin, immediately, within 5 minutes. Y 03/13/2001 03/14/2001 1 PVT PVT NONE 1
0169001 04/24/2001 KS 5.0 5 M 01/18/2001 Pt began to cough with edema and blueness under eyes. No SOB or tightening of throat. Epinephrine was given SC in left deltoid. Signs and symptoms cleared in 10-15 minutes. Y 01/18/2001 01/18/2001 0 NONE PVT OTH NONE NONE NONE 1
0169002 04/24/2001 WI 5.0 5 M 03/12/2001 Child had slight cough before vaccines given. He developed a fever about 3 hours, post vax. Had had a fever "on and off" since going as high as "almost 103F". Cough has become worse. Mother is giving both children's Tylenol and Motrin together since 3/7/01. Told to call doctor. He was dx'd with earl infection. Y Y 03/07/2001 03/07/2001 0 PUB PUB NONE Cough NONE 1
0169003 04/24/2001 CA 12.0 12 M 02/15/2001 Pt received vaccines on 9/29/00. Today on 2/15/01, complaining of area of tissue atrophy and hypo-pigmentation 2" X 1" over injection site. Y 09/29/2000 02/14/2001 138 PVT PUB ADHD ADHD; Allergic Rhinitis; Reaction to insect stings 1
0169004 04/24/2001 CO 58.0 58 F 03/16/2001 Seen today, after vaccination on 3/13/01 into left deltoid for local erythema, edema, tenderness, generalized body aches, headache, low-grade fever, chills, dry hack-like cough and bilateral conjunctivitis. Y 03/13/2001 03/13/2001 0 BP 124/78; Pulse 64; Resp 12; Temperature 98.9F; Pulse OX 97% OTH OTH Premarin NONE Allergy to codeine; history of renal calculi 1
0169006 04/24/2001 IA 14.0 14 M 02/22/2001 Non-itchy rash on neck, trunk, arms and legs, starting on 2/9/01. Reported from pt's mother on 2/16/01. States she hasn't noticed the rash since 2/14/01. Y 01/31/2001 02/09/2001 9 PUB PUB 1
0169007 04/24/2001 TN 1.08 1 .1 M 03/07/2001 3" X 5" red, swollen area on thigh. Y 03/05/2001 03/06/2001 1 NONE PVT PVT Tylenol; Benadryl NONE NONE 1
0169008 04/24/2001 CA 0.2 0 .2 M 03/01/2001 Hives on thighs, extending to lower extremities and lower torso. Treated with Benadryl. Y 10/26/2000 10/27/2000 1 PVT PVT NONE NONE NONE 1
0169009 04/24/2001 CA 0.3 0 .3 M 03/05/2001 Hives on face, limbs, torso; lasting 2 weeks. Treated with Benadryl X 2 days prior to vaccinations given. Continue Benadryl. Y 12/27/2000 12/28/2001 366 PVT PVT NONE Allergy to 1st immunization (same) Allergic reaction~Vaccine not specified (no brand name)~1~0.00~In Patient 1
0169010 04/24/2001 SD 25.0 25 F 04/09/2001 Reddened, hot and hard area the size of a softball. Cellulitis dx'd at Urgent Care. Y Y 04/05/2001 04/07/2001 2 WBC-9,000 PVT UNK NONE NONE Allergy to Penicillin and codeine 1
0169011 04/24/2001 CA 51.0 51 F 03/27/2001 Onset of generalized rash and joint pain, 12 days, post vax of MMR vaccine. Pt sought medical care from her private physician. Y Y 03/12/2001 03/27/2001 15 OTH PUB NONE 1
0169012 04/24/2001 MN 4.0 4 F 04/12/2001 The pt experienced a red rash the size of a grapefruit which was warm to the touch (10x8cm) slightly hard to feel, no tenderness, no pruritis, no fever. Onset was within 24 hours of administration. Given Benadryl and observed. Y U 04/10/2001 04/11/2001 1 PVT PVT BOM 1
0169013 04/24/2001 PA 1.4 1 .4 M 02/19/2001 The pt experienced a possible low grade fever and morbilliform rash. U 02/08/2001 02/19/2001 11 NONE OTH PUB NONE NONE 1
0169014 04/24/2001 OH 4.0 4 F 02/14/2001 24 hours post vax, the pt developed a red and swollen arm which was warm to the touch. Y Y 02/12/2001 02/13/2001 1 NONE PVT UNK NONE otitis media 1
0169015 04/24/2001 VA 23.0 23 F 02/27/2001 On 2/23/01, the pt noticed chicken pox has approximately 7 blisters. U 02/09/2001 02/23/2001 14 PUB PUB NONE NONE allergy to pollen and dust 1
0169016 04/24/2001 IL 1.55 1 .5 F 02/28/2001 The pt experienced a large amount of swelling to the thigh beginning 36 hours post vax and lasting 3 days which was approximately the size of an orange and 3/4 around the thigh and was very red and hot to the touch. The child was fussy and did not feel good. Temp is normal. Treated with Tylenol every 4 hours. Y 02/21/2001 02/23/2001 2 NONE PUB PUB NONE NONE NONE 1
0169018 04/24/2001 MI 57.0 57 F 02/04/2001 On 1/6/01, the pt noticed that her left arm was extremely red, swollen and hurting. On 1/7/01 went to employee health and a prescription was given for Amoxicillin for 10 days. Y Y 01/06/2001 01/06/2001 0 NONE MIL MIL NONE 1
0169164 04/24/2001 SC 49.0 M 04/20/2001 This report is from a physician referring to a 49 year old male. No known drug allergies. The vaccinee has type II diabetes and takes Glucophage, Sinemet, Serzone and Univasc. On 2/18/00, the pt received his 1st IM, left deltoid dose of Havrix. 90 minutes later, on 2/18/00, the pt experienced a rash. Outcome: ongoing. 2-3 days, post vax, the pt experienced a sore throat. Outcome: ongoing. A doctor visit was required and the vaccinee was treated with Benadryl and steroids (NOS). The most recent information, received on 2/24/00, reports the condition of the vaccinee as ongoing. Y N 02/18/2000 02/18/2000 0 Strep test-neg PVT PVT Glucophage, Sinemet, Serzone, Univasc Type II diabetes 20000058131 1
0169165 04/24/2001 SC 49.0 49 M 04/20/2001 This report is from a nurse referring to a 49 year old male pt and follow-up from his personal physician. The pt has an allergy to poison ivy. The pt has a medical history of left shoulder impingement, type II diabetes, high blood pressure, obesity and restless legs. At the time of the event, he was taking Glucophage, Univasc, Sinemet, Serzone, Amaryl, Novocaine and cortisone. On 2/18/00, the pt received his 1st injection with Havrix 1440 Elisa units for prophylaxis. Approx. 1.5 hours later, the pt experienced a rash over his whole body with erythema, flatness and flushed face, without itchiness. The rash was treated with Benadryl 25mg 2X/day and resolved but reappeared later. Also, within 24 hours of the injection, the pt experienced pharyngitis with a severe sore throat and difficulty swallowing. On 2/21/00, during an office visit, it was noted the pt had 2 pustules on his tonsils. Penicillin VK 250mg every 6 hours for 10 days was begun. The pt saw a dermatologist and had a biopsy performed. The dermatologist dx'd an allergic reaction to Havrix. The pt was treated with an unspecified medication. The information received on 3/29/00 reports the pharyngitis improved, and the rash is not well dissipated after treatment. N 02/18/2000 02/18/2000 0 Throat culture-neg; skin biopsy-allergic reaction to Havrix OTH OTH Glucophage, Univasc, Sinemet, Serzone, Amaryl, Novocaine, Cortisone High blood pressure, left shoulder impingement syndrome, obesity, allergy to poison ivy, restless legs and Type II diabetes. 20000064031 1
0169167 04/24/2001 CO 42.0 M 04/20/2001 The pt was vaccinated with Engerix-B at the same time as he was vaccinated with Havrix; 1 vaccine in each arm. On 3/27/00, the pt received his 1st dose of Havrix. On 3/29/00, he experienced a red and swollen rash from the armpit down body. An ER or doctor visit was required. The most recent information, received on 3/29/00, reports the condition of the vaccinee as unknown. Y U 03/27/2000 03/29/2000 2 OTH OTH UNK 20000116281 1
0169168 04/24/2001 NC F 04/20/2001 On an unspecified date, the pt received her 1st dose of Havrix. A "few" days later, the pt reported axilla pain. Physician is not "even sure the pain is related to the injection". The most recent information, received on 4/3/00, reports the condition of the pt is unknown. U OTH OTH 20000119351 1
0169169 04/24/2001 SD 42.0 M 04/20/2001 This is a spontaneous report from a paramedic referring to a 42 year old male. The pt had a cold (illness) at time of vaccination. On 4/4/00, the pt received his 1st IM left deltoid dose of Havrix. One hour later, he experienced chest tightness, tingling, and sweaty palms. Pulse oximetry was required. On room air, BP 120/88, oxygen saturation 95%, HB 66 and normal rhythm. The most recent information, received on 4/4/00, reports the condition of the vaccinee as ongoing. N 04/04/2000 04/04/2000 0 BP 120/88; Oxygen sats-95%, HB-66, normal rhythm OTH OTH Cold (illness) 20000120521 1
0169170 04/24/2001 OH 15.0 F 04/20/2001 This is a spontaneous report from a pharmacist/mother referring to her 15 year old daughter. On 4/11/00 at 13:00, the pt received her 1st IM, right deltoid, dose of Havrix. One day later, on 4/12/00, the pt was feverish and achy with fatigue. On 4/13/00, her fever was higher 102F and symptoms were persisting. No treatment was given. The most recent information, received on 4/13/00, reports the condition of the vaccine as ongoing. N 04/11/2000 04/12/2000 1 OTH OTH 20000122051 1
0169171 04/24/2001 NY 37.0 M 04/20/2001 On 4/17/00, the pt received his 1st IM, left deltoid dose of Havrix. Subsequently, on 4/17/00, he felt like fainting, he felt as if he could not breathe, he experienced pallor, red ears, palpitations, chest tightness, light-headedness, difficulty concentrating and fatigue. His BP was 140/90 (high for him). Physician thought it might be a vasovagal reaction. The pt noticed that his beard was growing more slowly; he shaved every day, but since yesterday, he didn't have his usual 5 o'clock shadow. After the initial events, the pt reported feeling generally unwell with episodic palpitations and "disequilibrium". This latter symptom was described as a feeling of spatial disorientation that lasted for "a second" after a rapid change in head position; there was no sensation of the room spinning, loss of consciousness or diplopia. This symptom gradually resolved approx. 10 days, post vax. The pt also reported developing a sore throat and fever on 4/22/00. He reportedly, experienced episodes of sweating and palpitations. The fatigue and malaise continued and were accompanied by an episodic, pounding headache. The pt denied myalgias, rhinitis, otalgia, fever or chills, and was reportedly, examined by his PCP on 4/26/00. The pt's physician did not obtain an ECG or 24 hour Holter study. No treatment was given. The pt stayed out of work during the week of 4/24/00. His symptoms largely abated by the end of the week and he was back at work by 5/1/00. He was able to drive. The most recent information, received on 5/1/00, reports the condition of the vaccinee as resolved. Y 04/17/2000 04/17/2000 0 BP 140/90 (high for him) OTH OTH 20000123481 1
0169172 04/24/2001 NJ 37.0 F 04/20/2001 On 4/13/00, the pt received her 2nd dose of Havrix. Four days later, on 4/17/00, the pt experienced abdominal pain, diarrhea and nausea. The most recent information, received on 4/19/00, reports the condition of the pt as ongoing. N 04/13/2000 04/17/2000 4 PVT PVT Zyrtec Allergic to mushrooms, pollen and strawberries. Medical history unspecified. 20000123581 1
0169173 04/24/2001 TX 12.0 12 M 04/20/2001 On 4/20/00, the pt received his 1st dose of Havrix. Physician reported that he was experiencing severe fatigue, epigastric discomfort and diarrhea. Physician reported that the pt had severe eosinophilia and that he could not be sure it was not present prior to the Havrix. Additionally, he was not sure that the fatigue developed after the Havrix. The gastrointestinal discomfort has improved. The diarrhea occurred for 1 day only, then resolved. On 5/19/00, physician visit: Physician noted that the pt had a 1 month history of unusual fatigue and eosinophilia noted on peripheral blood counts. No fever was noted with the pt's recent symptoms, but the pt did complain of abdominal discomfort and a sense of abdominal fullness and nausea after completing 1/2 of his meal. He had diarrhea for 1 day in early May, 2000, with normal stools since that time. He had been so fatigued that he had been unable to participate in his usual tennis competition and had missed some school. There is no history of unusual exposure to illness or toxins and no travel to exotic sites. He did receive a routine Hep-A vaccine. Physical exam was normal. On 5/19/00, Allergist visit: It is unclear whether the pt's symptoms began before or after receiving the Havrix on 4/20/00. However, his parents contacted physician on 4/27/00 with at least a 1 week history of fatigue, malaise and epigastric discomfort. He had no other GI symptoms (except for car sickness) prior to this episode. Allergist had no explanation for the pt's significant eosinophilia. The fact that he has had prior normal eosinophil percentages on his hemograms suggested that this was an acute event (which was hoped was resolving) rather than something related to his prior peanut allergy or mild allergic rhinitis. It is possible that he experienced an idiosyncratic reaction to the Hep-A vaccine. It is possible that he may have eosinophilic gastroenteritis. Hypereosinophilic syndrome would require absolute eosinophil count, 1500 per micro liter for more than 6 months. Current eosinophil count was 1458. He had no signs or symptoms of specific organ involvement other than mild epigastric pain and severe fatigue. Physician reports that the fatigue and the eosinophilia are still resolving and are definitely better. He had a "complete work-up" and all tests were "normal". Physician reported that the pt had prior CBC with differential that was normal. WBC-6,000 on 4/27/00. The vaccinee has regained 6 of the 10 pounds that he lost. Current WBC count is 12,000 with 2% eosinophils. The elevated SGOT and SGPT values resolved by 6/1/00. The most recent information, received on 8/9/00, reports the outcome of the event as improving. Y N 04/20/2000 04/27/2000 7 Lab data revealed an eosinophil percentage of 32% with a WBC of 6,000 (for a calculated eosinophil count of 1920) with a normal hematocrit, hemoglobin and platelet count. Subsequently, WBC-7,800 with 41% eosinophils (for a calculated eosinophil count of 3198). IgE-2149; other antibody levels-nml; EBV titers-neg; Toxocara antibodies-absent; On 5/4/00: AST-75 (10-42); ALT-91 (8-39); WBC-9,700 with 41% eosinophils (for a calculated eosinophil count of 3977). ON 5/12/00, WBC-7,800 with 25% eosinophils (for a calculated eosinophil count of 1950). Anti-nuclear antibody was neg. Abdominal ultrasound-nml. On 5/19/00, alkaline phosphatase-208; SGOT-31; SGPT-48 (7-42). PVT PVT Multivitamins; Dimetapp Allergy to peanuts and suspected allergy to milk 20000167951 1
0169174 04/24/2001 MN 34.0 M 04/20/2001 This report was received from a nurse concerning the occurrence of a rash in a male aged 34 years who was vaccinated with Havrix. On 4/14/00, the pt received his 1st vaccination with Havrix. After 6 days, 4/20/00, he experienced a full body rash. The most recent information received on 4/27/00, reported the symptoms resolved. Y 04/14/2000 04/20/2000 6 PUB PUB Allergy to Ampicillin (penicillin) 20000211161 1
0169175 04/24/2001 IL F 04/20/2001 On 12/22/99, the pt received her 1st dose of Havrix. "Right after the injection", she experienced headache, dizziness and was "hyper". Additionally, she lost her appetite and lost 20 pounds, experienced swollen lymph nodes and occasional yellow stools and muscle aches. Her feeling "hyper" subsided, but she still had loss of appetite, continued to lose weight, and had muscle aches. A doctor or ER visit was required. No treatment was given. Multiple tests were performed (NOS) but no dx was arrived at. The most recent information received on 5/10/00, reports the outcome of the event is unknown. Y U 12/22/1999 12/22/1999 0 Multiple tests (NOS)-no dx arrived at PUB OTH Allergic to penicillin; heart murmur; prolapsed valve 20000223131 1
0169176 04/24/2001 NV 21.0 21 F 04/20/2001 This report describes the occurrence of maculopapular rash in a 21 year old female who received her 1st dose of Havrix on 5/24/00 and 24 hours later, she experienced an erythematous maculopapular rash and lymphadenopathy (occipital and left clavicular). She had mildly swollen lymph nodes prior to the vaccination. She was without headache, photophobia, chills, myalgia, nausea, vomiting or itching. She was treated with Benadryl po on 5/25/00, after which her rash worsened. The most recent information, received on 5/26/00, reports the outcome of the event is ongoing. N 05/24/2000 05/25/2000 1 Rubella-wnl; Blood Immune testing-wnl; CBC (including eosinophils)-wnl; Syphilis-neg; HIV-pending PUB PUB Birth control pills (NOS) Mildly swollen lymph nodes 20000223181 1
0169177 04/24/2001 PA 38.0 M 04/20/2001 The pt received his 1st IM, right deltoid, dose of Havrix on 6/22/00. Three days later, on 6/25/00, he experienced a severe migraine. No treatment was given. The most recent information, received on 6/26/00, reports the outcome of the event as resolving. N 06/22/2000 06/25/2000 3 OTH OTH NONE NONE NONE 20000224051 1
0169178 04/24/2001 M 04/20/2001 On an unspecified date, the pt received the unspecified dose of Havrix. Subsequently, he developed elevated liver enzymes. Vaccinee reported that, per his physician, the elevated liver enzymes were related to Havrix. The most recent information, received on 6/26/00, reports the outcome of the event as unknown. No further information is available. U Elevated liver enzymes OTH OTH 20000224321 1
0169179 04/24/2001 IL 14.0 M 04/20/2001 On 6/6/00, the vaccinee received his 1st adult dose of Havrix. This was described as a mal-administration (wrong dose). The most recent information, received on 6/29/00, reports the outcome of the event as unknown. U 06/06/2000 06/06/2000 0 PUB PVT 20000225111 1
0169180 04/24/2001 NY 39.0 39 F 04/20/2001 On 3/13/00, the pt received her 1st IM, left deltoid dose of Havrix. On 3/22/00, 9 days later, the pt experienced swollen lymph nodes, muscle pain and a stiff neck. On 4/5/00, the pt self-treated with ibuprofen (Advil) and methyl salicylate/menthol (Ben-Gay) with "some relief". As of 5/18/00, the reporter noted that the pt had significant muscle tightness throughout her shoulders, neck and chest. She was treated with ibuprofen and physical therapy. As of 12/28/00, the outcome of the events is unknown. U 03/13/2000 03/22/2000 9 X-rays of neck-nml; Blood work-nml OTH OTH Claritin NONE UNK 20000244521 1
0169181 04/24/2001 MN 67.0 M 04/20/2001 Immediately post vax, the pt experienced a 3 X 3 rash, redness, itching and swelling at the injection site. the pt reported that he was seen by a physician in Guatemala who provided antibiotics (NOS) for 4 days and topical ointment without results. The outcome of the event is ongoing. Y U 05/16/2000 05/16/2000 0 OTH OTH Lipitor; Lopid; Glucophage; acetylsalicylic acid Type II diabetes mellitus 20000244661 1
0169182 04/24/2001 CA U 04/20/2001 Three days post vax, the pt experienced hives. The outcome of the event is unknown. U OTH OTH 20000244711 1
0169183 04/24/2001 CO 48.0 M 04/20/2001 Two weeks post vax, the pt experienced increased fatigue and depression. No treatment was given. These events resolved after two weeks. The outcome of the event is resolved. Y 10/27/1999 11/10/1999 14 PVT PVT Rebetron; Ribavirin; Interferon chronic Hepatitis C; depression; fatigue; Hepatitis B; recent trip to Mexico 20000244721 1
0169184 04/24/2001 FL 57.0 M 04/20/2001 Within hours post vax, the pt experienced pain in the injection arm down to the elbow and then down into his fingers. No treatment was given. The outcome of the event is ongoing. U 08/16/2000 08/16/2000 0 PUB OTH 2000025649 1
0169185 04/24/2001 OH 66.0 66 F 04/20/2001 On 2/18/00 and 8/18/00, the pt received her 1st and 2nd doses of Havrix, respectively. The pt had no adverse event after the 1st injection. Two days after the 2nd dose of Havrix, on 8/20/00, the vaccinee experienced a rash without fever. The rash began on her back and was very itchy. She was treated with Medrol Dose-Pak on 8/21/00 and 8/29/00. She was also treated with Elocon creme on 8/29/00. As of 9/1/00, there was no improvement in the rash. She was still breaking out. As of 9/1/00, the outcome of the event in unresolved. N 08/18/2000 08/20/2000 2 PUB PUB metronidazole (Metrogel), Accupril (quinapril HCL), Synthroid (levothyroxine sodium), Prempro (conjugated estrogens/medro Hormone replacement; hypertension, hypothyroidism, rosacea 20000262121 1
0169186 04/24/2001 AZ M 04/20/2001 On 8/4/00, the pt received the 1st dose of Havrix. Five days later, on 8/9/00, he experienced fever, malaise, fatigue, myalgia and nausea. As of 8/16/00, the outcome of the events in unresolved. N 08/04/2000 08/09/2000 5 OTH OTH 20000277061 1
0169187 04/24/2001 CO 62.0 62 M 04/20/2001 On 5/4/98, the vaccinee received his 1st dose of Havrix. On 8/17/99, he was found to have an AST of 192 U/L. He was found to have an ALT of 157 on 8/24/99. On 8/8/00, the pt received his 2nd dose of Havrix. Subsequent AST values were 173 U/L on 8/24/99 and 43 U/L on 3/23/00. Physician stated that the increased liver function tests were possibly related to alcohol consumption. The vaccinee was never symptomatic, reported the RN. As of 10/5/00, the pt's lab values were improving. N 05/04/1998 08/17/1999 470 8/17/99, SGOT-192 U/L (12-54); 8/24/99, SGPT-157 IU/L (11-51); SGOT-173 U/L;Biltot-1.6 (0.1-1.4); Conjugated bilirubin-.8 (0.0-0.5); Hep-A AB-text positive; Hep-B AG-test neg; Hep-B Surf AB and Core Tot-neg; Hep-A IgM-neg; Hep-C AB-neg; 3/23/00, Bildir-.3 MG/DL (0.0-0.3) and Bilind-1.6 MG/DL OTH OTH Vitamin E; Multivitamins; Viagra (sildenafil citrate); Hypertension; Increased cholesterol; Increased uric acid; Renal calculi; Splenomegaly; Stone in prostate; 2 alcoholic drinks daily. U20000277081 1
0169189 04/24/2001 CA 52.0 F 04/20/2001 On 9/8/00, the pt received her second dose of hepatitis A vaccine. Ten minutes post vax, she experienced a metallic taste in her mouth which overwhelmed her. As of 9/22/00, the outcome of the event is resolved. Y 09/08/2000 09/08/2000 0 PUB PVT Ativan allergy to iodine, PCN, sulfa, hypothyroidism 20000279821 1
0169190 04/24/2001 WI 30.0 F 04/20/2001 On 9/15/00, the pt received her 1st dose of Havrix and experienced mal-administration (expired vaccine). Additionally, she experienced whole arm pain (injection site). The reporter was told by the CDC that they consider this Havrix dose to be a "non-vaccination". As of 9/21/01, the outcome of the events is resolved. Y 09/15/2000 OTH OTH 20000284411 1
0169191 04/24/2001 TX 3.0 3 M 04/20/2001 On 9/23/00, th pt experienced a fever of 103. He was treated with ibuprofen (Motrin). As of 10/05/00, the outcome of the event is unknown. U 09/22/2000 09/23/2000 1 PUB PUB NONE NONE 20000287751 1
0169192 04/24/2001 OH 16.0 F 04/20/2001 On 3/22/00, the pt received her first adult IM dose of Havrix. Within seconds, post vax, she became severely pale and fainted. Her loss of consciousness lasted a few seconds and the episode resolved in 5-10 minutes. No treatment was given. As of 9/21/00, the outcome of the event was resolved. Y 03/22/2000 03/22/2000 0 OTH OTH DT received on 3/30/30 hx of passing out with prior vaccinations at the age of 4-5. She passed out while sitting watching a file on 12/21/99. No hx of seizure disorder passed out~DTP (no brand name)~~4.00~In Patient 20000301151 1
0169193 04/24/2001 MI F 04/20/2001 On 3/2/00 the pt contracted a severe case of poison ivy, which was treated with prednisone. On 9/1/00 she was found to be seronegative. No treatment was given. As of 9/21/00 the outcome of the event is ongoing. N 02/22/2000 09/01/2000 192 Hepatitis A AB - seronegative PUB OTH methylprednisolone, prednisone 20000301491 1
0169194 04/24/2001 40.0 F 04/20/2001 On approximately 9/2/00, the pt received her third adult IM dose of Havrix. No treatment was given. As of 10/2/00, no adverse events were reported. Y 09/02/2000 09/02/2000 0 OTH OTH 20000302431 1
0169195 04/24/2001 VA 18.0 F 04/20/2001 Subsequently the pt experienced an elevated SGOT and SGPT with normal alkaline phosphatase and bilirubin. A hepatitis screen showed her to be positive for Hepatitis A. As of 10/5/00, the outcome of the events is ongoing. Y N hepatitis screen - positive for hepatitis A, SGOT - elevated, SGPT - elevated, bilirubin - nml, ALKPH - nml OTH OTH 20000303411 1
0169196 04/24/2001 PA 56.0 M 01/20/2001 On 10/18/00, the pt received his first dose of Havrix. On 10/18/00 he experienced malaise, myalgia, arthralgias, fever of 102 and tingling body. He was treated with acetaminophen and rest. Symptoms resolved on 10/20/00. Havrix was discontinued. As of 10/20/00, the outcome of the events is resolved. Y 10/18/2000 10/18/2000 0 OTH OTH Baycol NONE 20000309521 1
0169197 04/24/2001 IL 0.4 M 04/20/2001 Subsequently following vaccination, the pt experienced a slight fever, which resolved within two days with treatment with acetaminophen. The infant did vomit and had decreased intake for two to three days also. The reporting physician attributed the vomiting to the mother giving the infant prune juice and increasing his Enfamil feeding from 4 ounces to 6 ounces. A dime-size lump remained at the injection site as of 10/20/00. All events resolved within three days. As of 1/23/01, the outcome of the events was resolved. Y 10/13/2000 10/13/2000 0 PVT PVT NONE NONE 20000309561 1
0169198 04/24/2001 PA U 04/20/2001 On 4/24/00, the pt received the first dose of Havrix, one month later, on 5/24/00, the pt experienced fainting. As of 10/24/00, the outcome of the event is unknown. U 04/24/2000 05/24/2000 30 OTH OTH 20000312841 1
0169199 04/24/2001 ID 46.0 F 04/20/2001 Within 24 hours, the pt experienced flu-like symptoms. Reportedly, the pt's sister also was home with flu-like symptoms. The pt's sister and nephew had the flu last week. The son started vomiting at 20:00 last night and the pt at 3:00. The nurse felt that the pt's symptoms were not related to Havrix. As of 11/14/00, the outcome of the events is ongoing. N 11/14/2000 11/14/2000 0 OTH PVT NONE allergy to cats and PCN 20000333251 1
0169200 04/24/2001 NY 52.0 M 04/20/2001 Immediately post vax, the pt experienced pain in his left shoulder, Havrix had been injected into the left deltoid. The pt reported that the pain persisted as of 11/21/2000. The physician reported that the pain resolved without treatment, on 02/15/2000. The physician considered the injection site pain to be related to Havrix administration. N 01/20/2000 01/20/2000 0 PVT PVT 20000339051 1
0169201 04/24/2001 NJ 61.0 61 F 04/20/2001 On 10/30/2000 and 11/30/2000, the pt received first and second doses of Havrix. On 12/10/2000, the pt experienced diarrhea. The reported stated that the adverse event was moderate in severity and possibly related to Havrix (but doubt). As of 01/02/2001, the outcome of the event is resolved. Y 11/30/2000 12/10/2000 10 OTH OTH 20000355531 1
0169202 04/24/2001 NC 40.0 F 04/20/2001 Approximately 6 weeks post vax, the pt experienced nausea and fatigue. She was seen by her physician who performed a hepatitis profile and hepatitis A antibody titer. The hepatitis profile was negative; the hepatitis A titer was positive. The pt recovered after two weeks. Y Y 03/07/2000 04/01/2000 25 Hepatitis Profile: Negative; Hepatitis A Titer: Positive PUB OTH Coumadin history of stroke 20000360401 1
0169203 04/24/2001 WI 57.0 57 F 04/20/2001 24 hours post vax, the pt experienced the sensation of a knot in her throat. 30 hours post vax the pt experienced pain in both great toes. 48 hours post vax, the pt developed redness, stiffness and swelling of the fingers on both hands. The redness, stiffness and swelling migrated from finger to finger. She was seen by her primary care physician. An arthritis panel and Lyme titer performed were negative. The physician prescribed a 5 week course of Vioxx. The sensation of a knot in the throat resolved one week after onset. The toe pain resolved one to two weeks after onset. The finger redness, stiffness and swelling resolved after an unspecified period of time. Y Y 05/30/2000 06/02/2000 3 Arthritis panel: Negative; Lyme Titer: Negative PVT PVT Prempro; Pentasa; vitamin E; calcium; vitamin C colitis 20000363041 1
0169206 04/24/2001 NJ 4.0 F 04/20/2001 Subsequent to receiving vax, the pt was determined to have elevated liver function test results. Medical history is significant for household exposure to hepatitis A, the the pts father. U Liver Function Tests: Elevated OTH OTH 20010007611 1
0169207 04/24/2001 AK U 04/20/2001 Subsequent to receiving an unspecified dose of hepatitis A vaccine, the pt experienced injection site swelling and redness. As of 01/19/2001, the outcome of the event is unknown. U OTH OTH 20010017092 1
0169208 04/24/2001 MI F 04/20/2001 Subsequent to receiving the first dose of Havrix, the pt experienced a rash. As of 01/23/2001, the outcome of the event is unknown. U OTH OTH 20010018671 1
0169209 04/24/2001 MO 6.0 M 04/20/2001 36 hours post vax, the pt developed a fine, non-pruritic, pinkish rash on his back, arms, groin and buttocks. Three days post vax, the rash began to spread to his legs and began to itch. He was seen by a physician. A throat culture was negative to Streptococcus. The pt was treated with Benadryl. The rash and itch persisted as of 01/25/2001. Y N 01/22/2001 01/23/2001 1 01/25/2001 - Throat Culture: Negative for Streptococcus PVT PVT 20010020351 1
0169210 04/24/2001 PA F 04/20/2001 Subsequent to receiving first and second doses of Havrix, the pt was sent to Central America to do missionary work and contracted Hepatitis A. As of 02/06/2001 the outcome of the event is unknown. U OTH OTH 20010039381 1
0169020 04/25/2001 IL 0.2 0 .2 M 06/06/2001 It was reported that a 2 month old healthy male infant was vaccinated on 4/17/01 with IPOL, DPT and Hib-Titer. Reportedly, the parents found the baby dead in the morning of 4/18/2001. An autopsy is being performed. Sudden Infant Death reported. Autopsy report findings: Hirschsprung's disease. Y 04/18/2001 N 04/17/2001 04/18/2001 1 Autopsy findings: Hirschprung's disease, acute congestive heart failure, chronic esophagitis PVT PVT Patient had uneventful birth 02/05/01. Sister had strep infection 3 WEEKS AGO BUT THE BABY DID NOT GET SICK. U2001006400 1
0169021 04/25/2001 CA 32.0 F 04/17/2001 Information has been received from a 32 year old female consumer with no past medical history or known allergies. On 10/16/00 and 12/12/00, the pt was vaccinated with a 1st and 2nd dose of varicella virus vaccine live 0.5ml, respectively. There was no concomitant medication. The consumer reported that she conceived on 1/26/01 and discovered that she was pregnant on 2/28/00. Based on the date of conception, the calculated date of LMP was 1/12/01. It was reported that the pt had no diagnostic tests during pregnancy and there were no infections/illnesses during pregnancy. The pt did not take any prescription drugs during pregnancy. Follow-up from the physician indicated that the pt had a spontaneous abortion, 6 weeks from her LMP. No further information is available. N 12/12/2000 02/28/2001 78 OTH OTH NONE Pregnancy (LMP= 01/12/01) WAES01031642 1
0169022 04/25/2001 NM 0.5 0 .5 F 02/27/2001 A patient received DTaP #3, IPV #3, Comvax #1, on 02/21/01 during her well baby visit. The patient was found blue and unresponsive at home midday on 02/26/01. She was transferred to the ER unable to resuscitate. The ER Dr states the patient was secured in infant seat device to maintain upright position. The patient was found in infant seat turned on side , the foster mother had been out of the room approximately 10 minutes. ER doctor states "probable positional asphyxia"). The patient had been well prior to death. Y 02/26/2001 N 02/21/2001 02/26/2001 5 Autopsy ordered PVT PUB Reglan, Zantac, Bactrim Chronic laryngotracheomalacia Laryngotracheomalacia; GERD; left ureteral vesical junction obstruction NM030001 1
0169023 04/25/2001 CO 53.0 51 M 04/18/2001 Loss of concentration, dizzy, memory loss, mood swings, night sweats, tinnitus, joint pains, increased BP, low pulse, syncope, staring spells for 5-10 minutes duration, numbness and tingling of left upper and lower extremities, splinter hemorrhages, 75 lb weight loss, rash and swollen glands. Also, had Anthrax vaccines on 10/31/98, 11/9/98, 4/4/99, 11/99 and 6/3/00. Committed suicide. Autopsy report received states pt cause of death as gun shot wound to the head. Death certificate confirms cause of death. Y 04/02/2001 N 11/09/1998 MIL MIL Per death certificate: clinical history of post traumatic stress syndrome 1
0169025 04/25/2001 PA 3.0 F 04/17/2001 Information has been received from a pharmacist concerning his approx. 42 month old daughter who was vaccinated with MMRII and DTP. Subsequently, the child developed autism and the father "feels that the autism may be due to the vaccines that his child received." The child received unspecified medical attention. Upon internal review, the pt's autism was considered to be "Other Medical Event". Additional information has been requested. Y U OTH OTH UNK WAES01040432 1
0169026 04/25/2001 PA 39.0 39 F 04/17/2001 Information has been received from a pt's husband concerning a 39 year old female with penicillin allergy who on 4/4/01 was vaccinated with Hep-B recombinant (yeast). Concomitant therapy included quetiapine fumarate (Seroquel) and "other medications" that the husband was unable to recall. On 4/5/01, the pt began to experience "flu-like symptoms". She had a fever, headache, upset stomach, vomiting, belching, cough, dizziness, nasal and chest congestion. The husband reported the pt could not stand by herself. The husband stated that the pt was "very sick". At the time of the report, the pt's condition had not improved. The husband did report the flu virus had been "going around" his wife's place of employment. The pt saw her physician who administered an unspecified injection in her back on 4/11/01 to help her with nausea and vomiting. Upon internal review, the pt not being able to stand by herself was determined to be an "Other Medical Event". Additional information has been requested. Y N 04/04/2001 04/05/2001 1 UNK UNK (therapy unspecified); Seroquel Allergy to PCN WAES01041294 1
0169027 04/25/2001 KS 44.0 43 F 08/22/2001 It was reported that a 44 year old female pt was bitten by a dog in 1998. The pt began the Imovax Rabies series on 2/4/98 with dose #1; #2, 3 and 4 were given on 2/6/98, 2/11/98 and 2/18/98. Five days, after dose 3 (2/16/98), the pt developed "paralysis" of the face and was hospitalized. Pt still has damage to optical cortex of left eye, "stroke-like" effects of left side of face (drooping), her sense of smell and taste have been affected. Dx'd by neurologist as Bell's Palsy. The pt did not receive dose #5. From follow-up received on 08/22/2001 it was reported, "On 02/19/1998, the physician advised to take dose #4. After this is when the symptoms worsened and the pt ended up in the hospital. Pt became sensitive to light and noise, experience dhorendous pain and sinuses collapsed on left side of face. Also experienced numbness in extremities and later loss of feeling when intimate. The day pt came home of hospital would be in for her shot. This in itself, was 4.5 hours after the designated time for shot-March 1998-two weeks after 02/19/2001. We are in litigation." Y Y 8 Y N 02/11/1998 02/16/1998 5 PVT OTH NONE NONE U2001006390 1
0169028 04/25/2001 ME 0.5 0 .4 M 04/11/2001 Pt in on 2/2/01 for 4 month well check and received Comvax and Prevnar in right thigh. On 3/23/01, mom called the office and stated "bruising" on right thigh where shots were given along with 2 lumps. No tenderness or redness. Had 2-3cm bluish-purple discoloration on right anterior lateral thigh. Dx'd with resolving hematoma from immunization. In on 4/6/01 for 6 month well check and had worsening discoloration and now 4 lesions. Referred to surgery (letter included). Dx'd with a sterile abscess and had incision and drainage by surgeon on 4/7/01. Y Y 1 Y 02/02/2001 03/23/2001 49 Sterile abscess- incision and drainage done on 04/07 by the surgeon. PVT OTH NONE NONE NKA 1
0169030 04/25/2001 NH 19.0 19 M 04/18/2001 Impaired memory/cognition, constant headache since 1/4/00; chest pains; 3 syncopal episodes (totaled car) (lost license), fatigue, personality change, episodes of disorientation with abnormal EEG; episodic atrial fibrillation and pool balance. Follow up report on 09/07/2001: "As of 08/31/2001, his status is unchanged." Y N 01/04/2000 01/04/2000 0 PCPK and troponin/no cardiac cath; EEG-abn (episodic atrial fibrillation) MIL MIL NONE NONE NONE 1
0169031 04/25/2001 OH 3.0 2 1 M 04/17/2001 This child had a fever, precipitating status epilepticus. ICU admission , not intubated. Y 3 Y 03/21/2001 Chest X-Ray PVT PVT Viral gastroenteritis Septo-optic dysplasia; Seizure 1
0169032 04/25/2001 MN 49.0 48 M 04/20/2001 This patient had extreme continuous pain in his joints and limbs. She has tried various prescription medications to reduce the pain, but so far nothing seems to be working. The patient no longer had active life is now controlled by pain. For the 60 day follow-up pt states," I still have very bad pain resulting from the 2nd vaccination on 07/10/1999. I have tried many medications but so far nothing helps. It has comletely changed my life in a negatve way. In Doc 213373, annual follow up patient states the following: "I have pain throughought my body and it has increased in intensity. It is constant, residing in the joints and muscles, and so far. No medication seems to help much. Living hell! I am afraid that the pain will keep getting worse. I can barely stand it now. I hope that someone is studying this problem to find out how to reduce the pain and reverse the damage". 7/26/02 Per correspondence from patient, his MRI indicates "severe demyelination of the brain". Y Y N 06/10/1999 06/22/1999 12 Previously tested negative for Lyme disease. PVT PVT Blood pressure medication; allergy medication; pain medication for headache Headache High blood pressure; Allergies to dust and pollen; Tension headache 1
0169033 04/25/2001 IL 0.2 0 .2 M 04/20/2001 This patient had DTP, then then had a temp of 104, catatonic, stomach cramps, and vomiting, and excreting mercury in his urine. Each subsequent vaccine (07/28/97, 10/17/97, 10/22/98, 05/12/1997, 04/28/97, 06/25/98) caused a high fever, catatonia, and vomiting. Ultimately, developmental delays and no speech . Diagnosed with autism. Especially MMR vaccine. Gastrointestinal (mercury). The 60 day follw-up states that the pt has a irriable bowel syndrome, heavy metals toxicity (currently under-going chelation with DMSA), autism, and learning delays. Excreting mercury and other toxic in feces. Speech, language developmental delays. Y N 05/12/1997 05/12/1997 0 PVT PVT NONE Allergies; stomach upset Allergy to wheat/dairy 1
0169034 04/25/2001 TX 1.3 1 .3 F 16 month old developed focal seizure (left sided) brief X 2, back to back, within a few minutes approx. 1 day, following 12 month vaccinations. Y 4 Y 04/06/2001 04/07/2001 1 CT;MRI:EEG;CDF;Blood;CSF Culture;HSV PCR; RSV-all negative PVT OTH NONE NONE 1
0169035 04/25/2001 CA 1.01 1 .0 F 04/17/2001 Febrile seizure, status epilepticus X about 30 minutes. Seen in ER and received anticonvulsant medication. Negative infectious workup. Patient is a 12 1/2 month old child referred prior to evaluation of an atypical febrile seizure, approximately two weeks priori to evaluation. She had an MMR and Varivax vaccination approximately 10 days prior to the episode. She was irritable throwing herself backwards when mother laid her down, rhythmic jerking was noted of all extremities and then her eyes deviated upwards and she appeared unresponsive. She was taken to hospital where a CT and an LP were normal. It took her approximately one week to get back to normal. During that week, she had vomiting and diarrhea after a fever for two days. Her father had a cold at that time. She does attend a co-op but reportedly no other children were sick. An EEG was to be scheduled but this has not been done yet. Y Y 1 Y 04/04/2001 04/13/2001 9 CT of head-nml; CSF-nml; Urine and Blood tests-nml PVT PVT NONE Runny nose NONE 1
0169036 04/25/2001 OH 4.0 3 F 03/15/2001 This child had a fever of Tues 03/13/01, 2 hours after her shot at about 10 AM to present 03/15/01 at 1:30 PM. Lethargy on Tues at 03/13/01 at 10 AM, continues at this time 3:30 on 03/15/01. Y 03/13/2001 03/13/2001 0 PUB PUB Motrin for fever NONE NONE 1
0169039 04/25/2001 VA 22.0 F 04/20/2001 Report 2001009942-1 described lump in the throat in a 22 year old female who received Hepatitis B vaccine recombinant (Engerix B) for prophylaxis of Hepatitis B. Reportedly, the vaccinee had no known drug allergies or medical history and received no concomitant medications. No adverse events were reported following the administration of doses 1 and 2 of Engerix B. On 04/17/01, the vaccinee received her 3rd "adult" dose of Engerix B. Ten to fifteen minutes post-immunization, she complained of "severe" chills, headache, dizziness, hot flashes, and a lump in her throat. She had shortness of breath. She was treated with Epinephrine ".3" SC, 1 dose on 4/17/01, oxygen via nasal cannula at 4 liters/minute and Benadryl 50mg IM, 1 dose on 4/17/01. The vaccinee's symptoms resolved the same day, following treatment. The reporter considered the allergic reaction to be severe in intensity and related to Engerix-B. As of 5/3/01, the allergic reaction resolved. This case is considered to be an "Other Important Medical Event". As a result of follow-up info received on 5/3/01, this report has been re-classified as serious expected. Y 04/17/2001 04/17/2001 0 PVT PVT Depo-Provera The pt is allergic to penicillin; height 52"; weight-140 lbs 20010099421 1
0169042 04/25/2001 0.2 0 .2 F 11/20/2001 Information has been received from a post marketing surveillance study concerning a 2 month old female. On 04/21/00, the infant received Prevnar, Hib, DTaP, Hepatitis B vaccine, IPV. The same day, upon awakening from a nap, she appeared to be choking on saliva. The infant developed pallor for approximately 5 to 10 minutes. She was seen in the ER and was found to have developed a fever of 101.2 degrees. At this visit the infant was diagnosed with fever with possible seizure vs. possible aspiration vs. reflux episode. Parents refused admission preferring to return to the hospital if necessary. These events were considered to be medically important. Choking and fever are expected; pallor is unexpected. As of 04/06/01, both medical monitor and investigator's assessment of relatedness is unknown. Follow up info received on 11/12/2001 clarified the description of the reported events. On 04/21/2000, while sleeping, the child "turned blue quit breathing, and was shaking, and salivating at the mouth." The child was treated with Tylenol. No personal history of seizure activity was noted. The child has since recovered with no recurrence of similar events following subsequent vaccinations. Y 04/21/2000 04/21/2000 0 NONE OTH OTH UNK UNK HQ9759317APR2001 1
0169044 04/25/2001 0.83 0 .8 U 04/18/2001 Information has been received from an investigator concerning a child who received a first dose of Prevnar as part of a trial. On an unspecified date, the child experienced infantile spasms. The event was managed with clonazepam. As of a follow up clinic visit on 07/11/00, the event had resolved. This event was considered medically important. Both the investigator's and the medical monitor's assessments were unknown. The child received a second dose of Prevnar on 08/07/00. No adverse event stemming from the subsequent vaccination has been reported. Follow up information receieved 04/19/2001 from the study investigator revealed the patient received Prevnar 06/01/2000. The investigator considered the event "outside the reportable window" and therefore, not related. A follow up report received 12/3/2001 adds: 11/16/1999 Well care states birth weight 8lb 4oz normal exam. 01/19/2000 normal exam. 01/26/00 2d hx of SOM, 1d cough, 2d runny nose assessed UI. 01/30/00 asthma, recurring OM. 01/31/00 asthma, doing better, tolerating meds well. 2/09/00 Seizure? seen in urgent care clinic for hx of 3 possible seizures with light fever, cough congestion. 1" 14 weeks ago when using albuterol. Eyes rolling back, "crunched body". Poss seizure disorder? scheduled EEG. 02/10/00 another episode today where crunched body and eyes rolled back lasting -30 seconds. Assessed infantile spasms, admit for Rx Klonopin. 02/10/00 neuro eval. States: Infantile spasms. Previously healthy infant described as starting new activity of arm/leg flexion, coincidental with starting nebulizer medication was discontinued and he continued to have this activity.. Discussin with pediatrician this AM, I recommended an EEG to evaluate for infantile spasms. Result indicate hypearrythmia. Fam hx sister with febrile seizures. Nondysmorphic. Exam: Well appearing male, no abnormality detected. Impression: infantile spasms by hx. Recommendations: 1. MRI to r/o structural lesion (e.g. TS). 2. Start Klonopin 0.01 mg/kg 012. 3. Order ACTH 20 in/day for 2 wks when gradual taper by 5 units over every 5 days, followed by Prednisone 2mg/kg with taper over 2 wks. 4. Woods lamp evaluation. 02/10/00 Markedly abnormal EEG because of frequent, multifocal and generalized epileptiform activity and high amplitude slowing of the background. Consistent with hypsarrhythmia. Discharged 02/15/00 with dx infantile spasms. 2/21/00 urgent care appt for 2 episodes that day, also URI, w/o fever. 02/28/00 seen for an rx but continues to have seizures assessment. 02/29/00 EEG abnormal again consistent with infantile spasms. 03/20/00 well child visit states: 1. well child. 2. infantile spasm with box checked indicating normal neuro exam as part of physical. To continue Klonopin, prednisone taper. 03/28/00 neuro exam. Impression: Hx of infantile spasms, now improved, mild dev delay. Plan 1.continue Klonopin, prednisone as scheduled 2. return to clinic 2 wks. 04/07/00 second opinion neuro re infantile spasms. Impression infantile spasms, dev delay global, mild hearing deficit. 04/11/00 f/u of infantile spasms. No seizures since restarting Klonopin. Now off prednisone. Questions re hearing and left sided stiffness, mother reports poor vocalization. Exam: awake with eyes half lidded. EOM full and conjugte. Positive smile. Intermittent reactivity to sound, muscle tone good, normal/symmetric. Moving all four extremities, 0 hand preference, 0 parachute reflex. Sitting independently. Impression s/p infantile spasms, 7 hearing deficit, mild developmental delay plan continue Klonopin, referral to ophthalmology re eyes, EEG, audiology, return to clinic 1 month. 04/26/00 EEG wnl. Normal EEG for a child of this age, awake, drowsy and asleep. 05/04/00 cough. 05/09/00 f/u for inf spasms/dev delay. Repeat EEG normal. Development advances but no language. Exam: alert, playful, reacts to sound startle with good localization. 0 parachute reflex, 0 hand pref. positive taking grasp. Plan 1 decrease Klonopin to 1/2 tab in AM, 1 tab in PM. 2. RTC two months. F/U by phone. 5/17/00 Ophth exam states hx infantile spasms, pt seems to have problems focusing, slightly squinting, assessed: Pt was previously looking through eyes half-lidded but currently is not doing this-visually occurs with ptosis-had mult infantile seizures-it may be that the ptosis has improved with the seizure control plus stropine retraction. Normal ophthalmic exam. Probably pseudostrabismus return 1 year. 06/01/00 well child visit well 10 month old with h/o infantile spasms, speech delay. 06/23/00 urgent care appt for diarrhea. 07/10/00 EEG normal. 07/11/00 neuro exam: f/u for inf spasms, on Klonopin 0.1mg QD, no problems/seizures. Development continues, now cruising, moreo babbling. Exam alert playful male, squeling, muscle tone normal, no hand preference, pulling to stand with ease and stopping-pupils equal, round, reactive to light and accomodation, normal EOM. Impression resolved infantile spasms. Plan decrease Klonopin to 1/2 tab daily (0.05mg) return in 2 months. 7/17/00 cough. 08/07/00 well child, well 12 month old w/hx inf spasms, nl development (followed by regional center). 10/03/00 neuro f/u. No reports of seizures, more babbling. He has been walking for the past 6 weeks, no new issues, recurring OT, scheduled to meet with speech therapist. Exam: awake, playful male, babbling focussing on toys/faces. PERRL, ECMI, muscle tone/bulk normal. Walking well with wide based waddle, plan decrease Klonopin to 0.05 mg QD, return 7 months. 10/18/00 difficulty breathing, woke up from nap with difficult breathing, now with croupy cough. States "Dx asthma January, given med that gave him seizure. Now on Clonazapam". Dx mild tachypnea, febrile illness. 11/09/00 well child visit 15 month old w/hx of infantile spasms followed by neurologist, hitting developmental milestones. 11/10/00 eyebrow laceration. 12/05/00 neurologist: no reports of recurrent seizures, language has advanced-now babbling and having repetitive play, speech therapist is pleased with progress. Exam well appearing, no active disease. Decrease Klonopin to 0.05 mg QM, Th through 12/25/00 then 0.05 mg QM through 1/15/01, then stop. 01/04/01 tugging at ear 5-6 days. 01/23/01 neuro f/u for infantile spasms and speech delay. Off Klonopin as of 01/15/01 without recurrence in seizures. Still receives speech therapy through regional center. No new issues, family about to change insurance, f/u as needed. 01/28/01 ear pain, URI few days. 06/22/01 ophthalmology appt failed to keep/cancel. Y 06/01/2000 NONE UNK UNK UNK UNK HQ9760917APR2001 1
0169045 04/25/2001 0.13 0 .1 U 04/18/2001 Information has been received from an investigator concerning a 3 month old infant who received the 1st dose of Prevnar as part of a trial. On 07/28/00, the infant developed increasing episodes of "on and off" muscle spasms. On 07/29/00, the infant developed a single episode of muscle spasm with "one cry", and was seen in a clinic for evaluation. A diagnosis of benign infantile myoclonus was made. An EEG was performed, and the results were found to be normal. Myoclonic jerks is considered medically important. As of the date of this report, both the investigator's and the medical monitor's assessments are unknown. Follow up information on 04/19/2001 indicated that both the investigator and the medical monitor agreed that this event was not related to study vaccine administration. A follow up report received 12/03/2001 adds: No complications at birth. Gest age-40 weeks normal heart rate, resp rate, voiding, sucking, etc., breastfeeding well. Baby did well in course at home. On 4/11/00, at 12 days of age parents bring child in for concern re congestion, concerns re strained breathing. Good general exam with dx URI, healthy newborn. 04/17/00 normal exam, mild nasal congestion. 4/28/00 seen for nasal congestion, mostly at night. 4/29/00 diaper rash. 5/17/00 congestion, well (vaccinated). 5/22/00 seen for 1. diaper rash, dx'd candida 2. concern re "jerking" movements of neck and extremities, no cries or change in behavior. Development appropriate, no neonatal hx of significance. Description consistent with benign myoclonic seizures. Mother to videotape. Consider neuro referral. 5/15/00 concern re arm/leg movements. Mother brought in video: observed-normal flexion-extension movements, unlikely to be myoclonic spasms. Neuro exam normal. 5/31/00 Neuro referral made. States: 2 mo old male, unremarkable preg, labor and delivery. Normal neonats. Parents have noticed intermittent jerking of arms, legs, head. (Parent) brought a video but (provider) could appreciate spasms. Parents now concerned re increase in spasmatic jerks. She will re-video. Could this be benign myoclonus infantile? Please eval. 6/8/00 Seen for f/u. States: Prior concerns re "jerking" movements. Mom states now decreased. Developmentally: smiling, active. Assessed probable benign movements. 6/22/00: Parent concerned re muscle spasms. Presumed benign myoclonus. Occurring on and off with increase of episodes last night then 1 cry while occurring. Was able to feed. Occurred again this AM with ability to feed. Positive tears. Myoclonus occurs while sleepy. Assessed benign infantile myoclonus. Plan: "Reassured infant +dehydrte +normal causes of d/o to f/u ..call if activity significantly increases." 6/29/00 Neuro clinic: "This is a beautiful almost 3 month old baby who presented with 2 1/2 month history of recurrent episodes of abrupt jerky movements. According to the parents, both of whom were present today, the baby has been having this activity primarily when he is falling asleep or through the night. Sometimes it is so severe that it wakes him up. The parents had to hold the arms. There has not been sustained tonic clonic activity. The baby otherwise has been developing quite well, thriving and feding without difficulties. There has not been any episode of arching. No episodes of nausea, vomiting. "History: Pt was the 6lb 13oz product of a full term pregnancy. At 32 weeks of gestation the mother had some per-term labor that was controlled with Nifepdipine. The mother took prenatal vitamins. Significant history has been negative other than the above. Circumcision was uneventful. The father is 36, the mother is 31. The father is caucasian. The mother is african american. The mother has a maternal cousin with a history of "muscular dystrophy". He is 33 years of age. He ambulates "with braces." Reportedly he also has seizures. The exact type of muscle disorder is not known by pt's mother. "Physical exam: normal. "Neuro exam: the baby was quite awake and alert, smiling, nicely fixating. Some simple cooing was noted. The cranial nerves appear equal and reactive. There was ophthalmoparesis. No nystagmus. The face was symmetric. Lower cranial nerves were normal. "Motor exam: The axial and perpendicular tone were normal. There was no evidence of tremors. No evidence of polyminiclonus. "Sensory exam: There was sensory recognition to pain. Deep tendon reflexes were 2+ in both arms and both legs. Plantar responses were down going. "Impression: Recurrent marked clonic activity during sleep. This clinical pattern is consistent with benign asleep myoclonus of early infancy. The examination today did not reveal the presence of any findings that suggest motor sensory deficits. The later on probability of that needs to be considered and followed, although not likely." "Recommendations: Obtain EEG. No medication indicated. If the EEG is normal certainly the symptom is consistent with benign asleep myoclonus. Unless he becomes more symptomatic or there is evidence of potential seizures or any significant abnormalities in the EEG, I do not think that neuroimaging is indicated at the present time. 7/23/00 exam for ear problem, no mention of jerking. 7/28/00: well care, states "recent appt with neurology-concerns that movements are benign myoclonus". Neuro exam at this visit states strong, reflexes normal, attempting to roll over, smiling. 8/2/00 EEG normal EEG recording in wakefulness for age. 9/13/00 well care visit w/o mention of concern other than statement of hx of benign infantile myoclonus. Imms delayed to URI symptoms. 9/29/00 OK for shots, immunized. Dx'd possible murmur, innocent vs. VSD. 10/04/00 ER for vomiting "likely reflux vs early gastro". 10/11/00 urgent care for rash on hand and face, vomiting, thrush. 10/27/00 f/u for murmur. Dx innocent murmur. 11/10/00 facial rash dx mild trauma vs bite. 11/22/00 URI. 12/04/00 URI. 12/20/00 well care mentions prior hx benign myoclonic movements and innocent murmur, normal child. U 05/17/2000 06/28/2000 42 Electroencephalogram - Normal EEG recording in wakefulness for age. UNK UNK UNK UNK 9766517 1
0169047 04/25/2001 CA 4.0 4 F 04/19/2001 This patient had an onset of prolonged left sided focal seizure. requiring IV Valium in the ER to stop her seizure. No reoccurrence to date. Y 1 Y 04/12/2001 04/15/2001 3 MRI of the Head - Neg. EEG with right sided focal abnormality. PVT PVT NONE NONE NONE 1
0169058 04/25/2001 1.4 3 M 11/15/2001 Information has been received from an investigator concerning a child who received a 1st dose of Prevnar as part of a study. The child had a history of cerebral palsy, developmental delay, and epilepsy managed with phenobarbital. The child's mother discontinued phenobarbital in 9/00, and the child began to experience startling episodes with sudden, rapid, bilateral arm abduction and extension with arching of his upper body and throat noises. The episodes last a few seconds and occur several times daily without any precipitating event. Upon clinic follow-up on 11/14/00, a dx of "most likely seizures" was made and Tegretol therapy was initiated. This event was considered "Medically Important". As of the date of this report, the investigator and the medical monitor assessments were unknown. Follow-up information received on 14 NOV 2001 revealed the child was born prematurely at 29 weeks gestation and had a history of "probably" pediatric respiratory distress syndrome which required ventilator suppor and apnea monitoring at home. The child also had a history of gastro-esophageal reflux. The child was administered prevnar on 26 MAY 200, at the age of 12 months. Concomitant medications included phenobarbital. Within two months of the discontinuation of phenobarbital therapy, the child experienced the epileptic episode described above. The exact onset of the episode was unknown, but it was reported at a neurology clinic visit on 14 NOV 2000. Tegretol (carbamazepine) therapy was initiated and a follow up appointment was scheduled at 2 months. On 28 DEC 2000 however, the child was hospitalized for acute gastroenteritis and gastro-esophageal reflux, nine days after being diagnosed with pneumonia. See case ID# HQ7672126FEB2001 for the report on that hospitalization. In MAR 2001, the child's mother reported that she noticed an increase in the child's muscle tone with facial muscle asymmetry and increased extremity spasticity/rigidity. The mother also reported that the child cries alot during the daytime and that his "trunchal muscle tone is not good and he has difficulty supporting himself in a chair." A Tegretol level was obtained and was reported as "ok". In JUN 2001, the child's mother reported that he has been seizure free since MAY 2001. The child's mother discontinued Tegretol therapy after the family went on a trip without the child's medication and he reportedly did "fine". A follow up report received 12/03/2001 adds: Past medical history: Subject born at 29 weeks gestational age by cesarean section. Had what was probably pediatric respiratory distress syndrome and was on ventilator for approximately 2 weeks. Weaned off briefly before he had the need for further ventilation before he went home. Sent home on apnea monitor. A visit not at 7 weeks indicates that pt had approx 2-3 apnea spells per day. Also seen at 7 weeks in ER for GE reflux. Diagnosed with cerebral palsy spastic quadriparetic pattern with general tightness. Seen regularly in orthopedics and physical therapy since 10/99. Child receiving physical therapy from "spontaneous motions, activities of his hands, and what sounds like increased spine tone and neck movements." Starting in early 1/00 mother begins to describe a change in his movements and he is evalated for seizures. MD described "tonic flexion of his arms, followed by extension, followed by a cry". Episodes last about 16 seconds and happened 3-4 times per week. In mid April mother describes increased episodes of asymmetric facial grimacing (pulls to left), with the arm movements and increased frequency to maximum of 4x in 24 hours. MD suggests starting phenobarb at this time 5 mg/kg/d (starting at 30 mg/tab, crushed and fed with food once daily). Received Prevnar on 5/26/00 and 12/08/00. On 11/14/00 pt seen by neurologist for follow-up for seizure condition. At this tmie history of cerebral palsy and generalized seizures is cited. Taking phenobarbital until 2 months prior to this visit but mother discontinued it. Behind in developmental milestones. Mother describes episodes when he seems to startle without any stimulus or aggravating factor. These episodes consist of a sudden rapid bilateral arm abduction and extension with arching of his upper body and is sometimes associated with a throat noise. It lasts a few seconds, and gradually he relaxes. He has a scared look in his eyes when this happens. This happens every day, several times a day unrelated to outside factors. Assessment: History of epilepsy, new episodes of sudden arching and extension of arms are most likely seizures. He also has CP, start on Tegretol, recheck in 2 mos. Hospitalized 12/28/00 for chief complaint vomiting. Hx of present illness states: "The pt is a 19-month-old male with CP who used to vomit approx once every other day but for the last 3 weeks has been vomiting 4-5 times a day. Since 12/24 he has been "constantly vomiting." Seen on 12/19 for cough and vomiting and dx'd with pneumonia, started on oral amoxicillin. At this visit, note states the following 5 problems: 1. Noisy breathing: they state that he has been evaluated in pediatric pulmonology who told parent that he was at risk for recurrent pneumonia. Scheduled for airway endoscopy. 2. Seizures: "He first had a seizure at 6 months of life. He was initially treated with phenobarbitol, however, for the last 4 weeks he has been on Tegretol and takes 40 mg 3 times a day. Recently, he hs been having 2-4 seizures per day; the mother attributes this to the fact that he is not retaining his anticonvulsant medications. 3. Developmental delay: He is unable to sit by himself. He does not crawl or stand. Additionally, the mother states that he has had a problem with tongue thrust and hyperactive gag reflex. 4. Cerebral palsy: He is followed by physical therapy, speech therapy and occupational therapy. 5. Wheezing. He has been treated in the past with albuterol. Initial impression indictes: 1. Hx of prematurity and CP with dev delay. 2. Hx of seizures. 3. Hx of noisy breathing and report that the pt is at increased risk for aspiration. 4. Hx of bronchospasm. 5. Hx of recurrent vomiting. Must consider acute gastroenteritis with acute versus chronic gastroesophageal reflux. No discharge summary dictated for this hospitalization but online record states diagnoses of: Nonin gastroenterit nec, oth convulsions, congenital quadriplegia, esophageal reflux, development delays nec. In March 01 note in chart stating that mother called re Tegretol level: "Mother has noticed recently and in the past that his muscle tone increases and he develops facial muscle asymmetry when he gets below a therapeutic level". Note states that his Tegretol level is to be adjusted to a 3.5 cc TID. Another in 3/01 indicates "Mother reports a lot of crying during the daytime. He seems to need to entertained most of the day. Gradual increase in extremity spasticity/rigidity. Trunchal motor tone is not good and he has difficulty supporting himself in a chair. PT is working with mother. Last year was seen by MD and the issue of using Baclofen was discussed. Mother decided not to use it because of condern about decreasing trunchal tone but she would like to reconsider this now. Tegretol level was OK. Assessment: CP with severe spastic quadriplegia." Note in June 2001 indicates: (Pt) is a child with quadriparesis secondary to CP, which is secondary to prematurity. He has history of epilepsy in the past but has been seizure free recently and is off antiseizure medications at present (earlier in note states Mom discontinued Tegretol in May after she left it at home while on a trip and child did fine without). Y 05/26/2002 NONE OTH OTH Phenobarbital Epilepsy NOS; Cerebral Palsy; Developmental delay NOS, Gastroesophageal refulx HQ9776117APR2001 1
0169059 04/25/2001 NJ 1.3 1 .4 M 04/18/2001 This patient was red and swollen around the injection site and hot to touch. Y Y 04/16/2001 04/17/2001 1 PVT UNK NONE NONE 1
0169060 04/25/2001 OH 1.25 1 .3 M 03/21/2001 The pt experienced a fever of 101.3, treated with Tylenol. The pt also experienced a rash, which was red on the trunk and face. The pt was also fussy. The child was sick with a virus on 3/11 to 3/18. 03/20/2001 PUB UNK GI virus 1
0169061 04/25/2001 WA 2.0 2 .1 M 04/18/2001 The pt experienced a fever of 103 and above, and a brief febrile seizure beginning approximately 26 hours post vax. Y Y 04/16/2001 04/17/2001 1 NI, CBC, Na+, K+, lytes/metabolic - nml PVT PUB Motrin NONE NONE 1
0169062 04/25/2001 IA 1 .2 F 04/16/2001 The pt experienced a hematoma to the right thigh. U 04/05/2001 04/14/2001 9 NONE PVT PVT NONE NONE 1
0169063 04/25/2001 KS 0.33 0 .3 M 04/12/2001 Mom called the clinic 48 hours later the pt experienced spots around the site of injection and on legs. Called 72 hours later and more spots appearing. No fever, no difficulty breathing. The pt then developed hives which appeared on trunk, under arms and both legs. No other problems noted. U 04/09/2001 04/11/2001 2 MIL MIL Nystatin Thrush UNK 1
0169064 04/25/2001 IN 1.75 1 .7 F 04/17/2001 On 4/11/01, phone call received from parent. States child developed an elevated temperature, the evening of 4/4/01, post vax Prevnar #2. Pt continued with fever on 4/5/01 and then a rash developed. Parent called family MD and was advised to give Benadryl. Child continues with rash (on back) today, 4/11/01. She was advised to have child checked by family physician. Parent feels this is a reaction to Prevnar. Child received Prevnar #1 without any symptoms. On 4/15/01, parent did have child checked by MD and no known cause was determined. Continues with Benadryl and rash is improving. Y Y 04/04/2001 04/04/2001 0 PUB PUB NONE NONE Allergic to penicillin 1
0169065 04/25/2001 MT 0.2 0 .2 F 04/16/2001 On 4/15/01, pt had a brief (10-15 second) tonic/clonic generalized seizures (3 in 1 hr) at 20:00, followed by 5 of slighter duration in the next 2 hours. Had none after phenobarbital. No fever at any time. Y 04/13/2001 04/15/2001 2 NONE PVT PVT NONE NONE Neonatal jaundice which started 2 weeks ago. ~DTP (no brand name)~1~0.30~In Sibling 1
0169066 04/25/2001 TN 1.25 1 .3 M 04/13/2001 Right thigh with 10cm X 8cm induration and erythema seen around site of DTAP injection. Non-tender. Y 04/12/2001 04/13/2001 1 PVT PUB 1
0169067 04/25/2001 AZ 1.0 1 .0 F 04/17/2001 Positive chickenpox after varicella injection given on 4/6/01. Onset 4/16/01. Y 04/06/2001 04/16/2001 10 PVT PUB 1
0169068 04/25/2001 GA 4.0 4 F 04/09/2001 Client received vaccinations on 4/5/01 at approx. 14:00. Around 16:00, she started itching on forehead and broke out with rash like papules on right side of forehead and broke out with rash like papules on right side of face, arm and body. Rash did not cross over to left side. Rash worsened to hives and continues to have papules on 4/9/01. Complained of itching and slight headache. Went to ER on 4/9/01 and dx'd by physician as reaction to Prevnar vaccine. Y Y 04/05/2001 04/05/2001 0 NONE PUB PUB NONE NONE NONE 1
0169069 04/25/2001 AZ 1.2 1 .2 F 04/13/2001 Red blister where varicella vaccine given. Y 03/28/2001 04/03/2001 6 PVT PUB NONE NONE NONE 1
0169070 04/25/2001 CA 5.0 5 F 04/16/2001 Redness, swelling and fever of 102.8F and enlarged at injection site 3" X 2" with extreme pain/sensitivity to arm. Y 04/05/2001 04/05/2001 0 NONE PVT OTH Fluoride NONE Congenital VSD, Short palate, left pupil irreg. 1
0169071 04/25/2001 IL 1.8 1 .8 F 04/25/2001 Prevnar given at 10:45 AM. On 4/19/01, pt developed a fever at 02:00 on 4/20/01. Mother didn't take temperature. Had red blotch (the size of a dime) at injection site. Pt complained of pain at the site today. Y 04/19/2001 04/20/2001 1 NONE PVT PUB NONE Cold NONE Fever~Vaccine not specified (no brand name)~~0.00~In Patient|~Vaccine not specified (no brand name)~~0.00~In Sibling 1
0169072 04/25/2001 LA 0.3 0 .3 M 03/21/2001 Mother calls and reports no temperature, cranky, tired, sleepy, "he jerked a couple of times". I don't know if it was a seizure or not, "he went right to sleep afterwards and he slept about 1 hour. Mom called MD's office and he was closed. MD called mom, mom did not call him. She called H. U. and it was closed. Mom called H. U. the next day. Baby was fine. Y 03/08/2001 03/08/2001 0 PUB PUB NONE NONE Heart murmur dx'd 1
0169073 04/25/2001 WA 1.2 1 .2 F 04/13/2001 Onset of induration and redness at varicella injection site with subsequent development of about 5 papules on the red base. On exam, site of redness 2cm X 2 1/2cm on 4/12/01. Mom today, reported small papule or vesicle on left calf and right thigh. Child has had a fever of 101.5F for the past few days. No respiratory symptoms. Eyes matted and has a runny nose. Y U 03/29/2001 03/31/2001 2 NONE PVT UNK Tylenol NONE History of bilateral pneumonia on 3/8/01 recovered by vaccination date. 1
0169074 04/25/2001 UT 0.25 0 .3 M 04/11/2001 Pt received Comvax and Prevnar on 4/8/01. On 4/10/01, mother noticed dusky appearance but no details on O2 sats. On 4/11/01, baby on 1/8 L O2, desaturated to 65%. Recovered, O2 increased to 1/4 L, baby desaturated to 75%. Recovered. Y 04/08/2001 04/11/2001 3 NONE PVT PVT Magnesium sulfate; Sodium chloride; Fer-In-Sol; Diazepam; Aldactazide; acetaminophen NONE 27 week premie; preparing for hospital discharge 1
0169075 04/25/2001 NY 0.3 0 .3 M 04/18/2001 Hypotonia and shock-like. Y Y 04/12/2001 04/12/2001 0 NONE PVT PVT NONE NONE 1
0169076 04/25/2001 NM 1.3 1 .4 F 03/17/2001 3cm X 4cm red, swollen and tender area on right upper outer thigh and slight rash around the area. Treat with warm compresses and Motrin. Y 03/14/2001 PVT PUB BSOM NONE NM030003 1
0169077 04/25/2001 NY 0.5 0 .6 F 04/16/2001 Pt developed fever of 103F, inconsolable crying > 3 hours, vomited X 1. Went to ER for full work-up, blood work and lumbar puncture. Y Y 04/12/2001 04/15/2001 3 CBC-fairly normal; Spinal Tap-nml PVT PUB NONE NONE Jaundice at birth 1
0169078 04/25/2001 SC 1.0 1 .0 F 04/12/2001 On 4/9/01 about 17:00, redness noted to RLT. Mom put child in warm water to soak and bathe child. Motrin was given for fever. On 4/10/01, mom took pt to ER due to fever of 103F with mom having given Tylenol and Motrin. Redness had worsened. ER evaluated and counseled mom to continue warm soaks and Tylenol and Motrin. On 4/12/01, mom brought pt in to be re-evaluated. RLT reddened with lower border skin taught and measures 6.5cm at widest point. Skin is not broken but warm to touch. Mom states fever continues but using Motrin and Tylenol to reduce. Fever today only around 101F-102F. Re=evaluation on 4/12/01 done at health dept. Y U 04/09/2001 04/09/2001 0 PUB PUB Allergy to Biaxin; rash over body SC0121 1
0169079 04/25/2001 OR 0.2 0 .2 F 04/11/2001 Per nurse at PMD's office, infant was seen by PMD on 4/10/01 with diffuse rash from head to toe. Scalp had rash, but face did not. Infant had "low-grade" fever the evening of 4/9/01. PMD provided no treatment but indicated to mom that it was probably vaccine related. Still has rash. U 04/09/2001 04/09/2001 0 NONE PUB PUB NONE NONE NONE OR200118 1
0169080 04/25/2001 CO 1.6 1 .6 M 04/17/2001 Entire left upper thigh was red, swollen, "on fire" and red bumps on 4/12/01. On 4/17/01, has 1.5cm-2cm firm, non-tender, movable mass on left anterior lateral thigh, no femoral adenopathy. No treatment. Y Y 04/11/2001 04/11/2001 0 NONE PVT PVT NONE NONE NONE 1
0169081 04/25/2001 AL 1.0 1 .0 M 03/29/2001 Pt's mom contacted MD on 3/22/01, regarding swelling, redness of upper left thigh, low-grade fever and pt would not walk for 1-2 days. No specific treatment by MD but just close observation. Y 03/20/2001 03/20/2001 0 PUB PUB NONE NONE NONE AL0104 1
0169082 04/25/2001 GA 28.0 28 M 04/17/2001 Chronic constipation followed by intense bouts of diarrhea, chronic fatigue, joint pain and memory loss. Treated with OTC laxatives, Pepto-Bismol, energy supplements, Chondroitin Sulfate and Ginko Biloba. N 11/15/1998 11/15/1998 0 NONE MIL MIL NONE NONE NONE 1
0169083 04/25/2001 MD 61.0 59 M 04/20/2001 In 2/00, complained of joint pains in both knees and surrounding tissue to include area of 8" above and below knees. Also, pain and tingling sensation in both ankles and heels. In 12/00, pain in joints spread to elbows, wrists, hands and became progressively worse. On 4/16/01 was given Rx for Celebrex 200mg QD. Y N 01/03/2000 02/01/2000 29 12/19/00-Lymes Immunology/viralogy-.6 (neg=1.0; pos=1.2 or >). On 4/16/01-Lymes Immunology Western Blot-negative. PUB PUB Cardura NONE BPH; High cholesterol 1
0169084 04/25/2001 NM 56.0 56 F 03/02/2001 Swelling and pain at left tricep/deltoid region. Pt complained of debilitating pain and discomfort. Has seen PCP twice and Rx'd with muscle relaxer and anti-inflammatory medication with little or no relief. Has appt with physician next week. Y U 12/20/2000 12/21/2000 1 PUB PUB Hormones NONE NM030002 1
0169085 04/25/2001 OH 49.0 49 F 03/07/2001 Pt received flu shot on 12/18/00. She notified me approx. 5 hours later, that she was having shooting pains up and down her arm. I told her to use Tylenol and ice. (Per her account, she was at the tail end of a 2 week cold and was feeling good and had no temperature.) The shooting pains progressed and radiated to her sternum by the following day. The pain worsened, but was off and on until she sought medical care on 12/28/00. The ER doctor told her he had seen several cases of people getting this reaction after the flu shot following an infection. Her 2nd ER visit was on 1/3/01 with pain intensified in left arm and left chest and sweating. She was treated with Toprol and Vioxx but was discontinued. She was put on Xanax and Paxil. She was transferred to another hospital. After tests, she was released after 24 hours with no cardiac problems detected. She had a few faint spells and was tired. On 1/15/01 to 1/21/01 she had heavy bleeding and large clots on menstrual period. On 1/22/01, ER visit with complaint of arm numbness. She did have a panic attack going through this and saw a counselor or therapist. She was put on valium and Celexa. It was ruled that this was not a psychological problem and no situational problem present that would cause this. The doctor told her it was physiological in nature. There has been no clear cut answer as to what happened to her, only that a possible viral infection "messed up her nervous system, causing a chemical imbalance." She is currently taking valium and she states if she doesn't take this medicine by 15:00, her hands start shaking. Y Y 12/18/2000 12/18/2000 0 EKG X 3 were normal. Her stress test, Echocardiogram, blood work-all wnl. Holter monitor-nml; arterial blood draw to rule out clots-nml; hormone tests, thyroid test-nml OTH PUB NONE End of 2 week head cold. Allergy to dust 1
0169086 04/25/2001 IL 38.0 38 M 04/11/2001 Received YF, MMR and Hep-B on 4/3/01 and pt reports that on 4/6/01, he felt fatigued and light-headed. He complained of low back pain. In the office he was noted to have a fine rash on arms and macular rash in clusters on both legs. Red, raised blister-like sore on right buccal mucosa. Temperature was 98.8F in the office with fine red, rash on both cheeks. U 04/03/2001 04/06/2001 3 Rubeola IgM/Rubella IgM drawn on 4/10/01; Rubeola virus IgG antibody: positive 1:40; Rubeola virus IgM antibody: negative OTH PVT Multivitamins and an "occasional sleeping pill" Occasional complaint of anxiety Allergies to dust, grass, mold, tree pollen (causes allergic skin reactions and acne). 1
0169087 04/25/2001 VA 22.0 22 F 04/19/2001 Within 15 minutes of receiving Hep-B injection, started feeling dizzy, hot flashes and chills. Feeling of lump in throat and also stated had a headache. Y Y 04/17/2001 04/17/2001 0 PVT OTH NONE NONE NONE 1
0169088 04/25/2001 PA 32.0 32 F 04/10/2001 Pt called today and was seen due to complaints of swollen arm at the site of the injection, fever of 100.3F, sweats, chills and nausea since 4/9/01. Y N 04/08/2001 04/09/2001 1 PVT OTH Laceration of right arm NONE 1
0169089 04/25/2001 PA 33.0 32 F 04/16/2001 Recombivax HB vaccine was administered to left deltoid on 9/10/01 at about 13:00. About 6 hours later, pt developed circumferential maculopapular lesions on erythematous base in left anticubital fossa. Rash was very pruritic. Awoke next morning to similar rash by left temple and erythema and swelling around both eyes. Started on prednisone and Allegra on 4/11/01. On 4/13/01, decreased rash, swelling and itching. No respiratory symptoms. No anaphylaxis. Normal vital signs. Y U 04/10/2001 04/10/2001 0 Rash testing-pending PVT PVT NONE NONE NONE 1
0169091 04/25/2001 MI 18.0 18 F 3 1/2 hours, post vax, pt began having sweaty palms and dizziness and then hands became hot down to slightly hot feet. Slight nausea and stomach pains. Ate lunch at 12:30. Splotchy hands, she said. Reported to clinic at 15:15. Vitals; BP-110/80; Pulse-92; Temperature 97.5F. Seen by MD and given Benadryl and ibuprofen. Y 04/23/2001 04/23/2001 0 NONE OTH PVT Proventil, Vanceril, Allegra NONE Asthma 1
0169092 04/25/2001 MA 13.0 13 F 03/27/2001 Post vax, pt complained of weakness, face very red, BP 120/90; Pulse-80; R-20. Vital signs were monitored for 1 1/2 hours. Range of BP 120/90 to 136/94; P-68 to 80; R-16 to20. Continued to complain of weakness, shakiness and feeling as though she was going to fall when she stood up. EMS was called and pt was taken to hospital. Told to have a recheck with PCP. Y Y 03/27/2001 03/27/2001 0 BP; Pulse and Respirations PUB PUB NONE NONE NONE MA0103 1
0169093 04/25/2001 IL 5.0 4 F 04/20/2001 Swelling and redness to immunization site. Y Y 04/16/2001 04/18/2001 2 NONE PVT PUB NONE Stepped on a nail 1
0169094 04/25/2001 CA 65.0 65 M 04/12/2001 3 hours, post vax, pt experienced difficulty focusing eye, body tingling, fatigue and inability to stay awake. Blood sugar checked and was 130. Pt slept for 1 1/2 hours and upon awakening, felt better but not normal. Had another similar episode approx. 22 hours, post vax. Referred to PMD. Y 04/11/2001 04/11/2001 0 PUB PUB Glucophage Diabetic CA010029 1
0169095 04/25/2001 IL 10.0 10 F 04/11/2001 Syncopal attack, 2 to 3 minutes, post vax. Fell to the floor striking right temple area; approx. 6mm abrasion to right temple from eyeglasses; estimated length of time of unconsciousness, 20 seconds; transported to hospital per father and school nurse. Her anxiety level was elevated at the thought of receiving a shot. Child's posture was rigid and eyes rolling immediately after falling. Sent home for observation with parents. Had an immediate swelling and discoloration of right temple area was evident; complained of drowsiness. Treated and released from ER. CT Scan of head-negative (except for sinusitis). Y Y 04/11/2001 04/11/2001 0 CT Scan of head-neg OTH PUB NONE Sinusitis (dx'd by CT of head, post vax) Allergy to penicillin; She previously had an episode involving drooping of one side of face, post vax, but had a negative CT of head. Blamed on medication reaction. Has 2 older siblings with seizure disorder. IL01009 1
0169096 04/25/2001 CA 33.0 34 F 04/06/2001 30 minutes, post vax, noted heat at site, face felt hot, co-worker noted face to be very red and slightly swollen. No SOB, wheezing or oral swelling. No rash. Return to clinic if redness of face, possible puffing around eyes or SOB. Has a slight headache. Rx'd Benadryl liquid and monitored. Stable on release to home with oral Benadryl and instructions. Y Y 04/06/2001 04/06/2001 0 NONE PVT PVT NONE NONE 1
0169097 04/25/2001 MO 6.0 4 F 04/20/2001 Several red bumps, some with clear blister areas. Y 06/15/1998 04/17/2001 1037 PVT PUB 1
0169098 04/25/2001 WI 1.5 1 .5 M 04/19/2001 Itching, swelling and redness on LAT. Y Y 04/09/2001 04/10/2001 1 PVT PVT NONE 1
0169099 04/25/2001 SC 10.0 10 F 04/05/2001 The next day, mother noted extreme tiredness. After 2 days, pt could not be roused from an afternoon nap and slept until most of the morning. Seen by FNP at school based clinic on 9/23/99 with mother, who stated child continues to be tired; also has a cough and headache and nasal congestion. On 10/01/00, seen for worsening nasal congestion, cough and postnasal drip. Mother stated child continued to be tired. Y 09/03/1999 09/04/1999 1 NONE OTH PUB NONE NONE NONE ~Measles + Mumps + Rubella (no brand name)~1~1.50~In Sibling|~DTP (no brand name)~~0.00~In Sibling 1
0169100 04/25/2001 WI 5.0 1 .0 M Had chickenpox (varicella) vaccine at age of 12 months. Had lesion (10-15) atypical with only a few being vesicular and 1 lesion. Scabbed over. R/o atypical chickenpox. Y 05/21/1996 03/06/2001 1750 PVT OTH Slight cough, no fever NONE 1
0169101 04/25/2001 NC 5.0 5 F 04/18/2001 3cm raised rash around injection site of DTP on right anterior thigh. Y 04/16/2001 04/18/2001 2 PVT PUB Claritin; Flonase NS NONE Allergies 1
0169102 04/25/2001 NY 12.0 12 F The evening she received the vaccine, the pt developed body aches, malaise and low-grade temperature and headaches. Symptoms were significant enough that she missed school. Y 04/11/2001 04/11/2001 0 NONE PVT PVT NONE NONE NONE Fever~DTP (no brand name)~1~0.00~In Patient 1
0169103 04/25/2001 MI 1.7 1 .8 M 04/12/2001 Local reaction in left thigh with erythema and swelling; 3" in diameter. U 04/10/2001 04/12/2001 2 NONE PVT PVT NONE NONE Morbilliform rash~Measles + Mumps + Rubella (no brand name)~1~1.40~In Patient 1
0169104 04/25/2001 VA 1.6 1 .3 M 04/18/2001 Rash (red, papular rash) over face, chest and extremities. No treatment. U 03/17/2001 03/27/2001 10 PVT PVT NONE NONE NONE 1
0169105 04/25/2001 FL 6.0 2 .0 M 04/19/2001 Mild varicella X 5-6 days. Y 05/28/1996 03/30/2001 1767 NONE PVT PVT NONE NONE 1
0169109 04/25/2001 GA 4.0 4 F 03/20/2001 At injection site, pt had a red, swollen knot. The size was (> quarter). It was feverish and very tender. Y 03/12/2001 03/13/2001 1 PVT PUB NONE NONE NONE 1
0169110 04/25/2001 IL 2.0 2 .9 F 04/17/2001 10cm firm knot, reddened, with swelling down to elbow and up to shoulder, painful to touch, no fever or crying. No complaints. Y 04/10/2001 04/11/2001 1 NONE PUB PUB NONE NONE NONE 1
0169111 04/25/2001 IN 1.08 1 .2 M 04/17/2001 Vaccine was given and within approx. 5 minutes, a welt developed just below where the vaccine was given, SC. The welt then got bigger and redness developed around the site. The pt was fine and wasn't bothered by it. Benadryl was given and pt was observed for approx. 1/2 hour. Welt appeared smaller with less redness after Benadryl. Y 04/17/2001 04/17/2001 0 NONE PVT PVT NONE NONE NONE 1
0169112 04/25/2001 WA 12.0 12 F Approx. 15 minutes, post vax, pt complained of feeling dizzy. She slumped to the floor in the restaurant down stairs. She didn't respond to her name. Her eye were closed. She was lifted off the floor and immediately fell again, unaware of her surroundings. She was taken back into the doctor's office. Missing vaccine information not available. Y 02/20/2001 02/20/2001 0 PVT UNK NONE NONE NONE 1
0169113 04/25/2001 GA 4.0 4 F 04/15/2001 Indurated, erythematous, slightly elevated area about 5.5cm X 4.0cm on right posterior lateral thigh. Presumed recovered. Y 04/11/2001 04/11/2001 0 PVT PVT NONE NONE NONE 1
0169115 04/25/2001 AK 42.0 42 F 04/14/2001 Local reaction with swelling, redness and warmth, 48 hours, post vax. Treated with ibuprofen and Benadryl. U 04/13/2001 04/13/2001 0 PUB PUB NONE NONE NONE 1
0169116 04/25/2001 IL 1.0 1 .0 F 04/17/2001 Mother called to report large "boil" on thigh where HIB/HEP administered. Area with increased redness. Rx'd Augmentin and Benadryl per MD. Y U 04/12/2001 04/13/2001 1 OTH OTH NONE NONE 1
0169117 04/25/2001 OK 2.0 2 .9 M 04/04/2001 Left arm swollen twice the normal size, inflammation, fever, redness and pain; injection site had purple dime-sized diameter around it. Benadryl and Motrin administered; returned to normal after 2 days of treatment. Y Y 03/01/2001 03/02/2001 1 NONE PUB PUB NONE NONE NONE OK0115 1
0169118 04/25/2001 TX 4.0 4 M 02/26/2001 Swelling and red rash to left arm (deltoid) where MMR and DTAP sites given. Y 02/23/2001 02/23/2001 0 PVT PVT NONE NONE NONE 1
0169120 04/25/2001 MA 26.0 26 F On 3/3/01, pt had vesicle type lesions noted on abdomen and buttocks. Fading. On 3/20/01, noted increased discomfort. Y Y 02/14/2001 03/03/2001 17 NONE OTH PUB Had annual Mantoux/00930P/SC/LA done on 1/13/01. Too many medicines to list. See attachments. GERD; Encephalopathy; Seizure disease; Gastrostomy; Cortical blindness; Esophagitis; CHR congestion; Mental Retardation and Motor; Microcephaly; Blind; Subluxation Hip; T & A; Mild right lumbar scoliosis, Chronic congestion; S/P pneumonia; Empyema. 1
0169121 04/25/2001 MA 30.0 29 F 03/23/2001 On 2/14/01, varicella vaccine given in right deltoid area. On 3/7/01, fluid filled blisters noted on abdomen, torso and groin. Noticeable discomfort. On 3/12/01, vesicles fading. Y 02/14/2001 03/07/2001 21 NONE OTH PUB Too many to list, see attachments. NONE Early acquired encephalopathy; spastic quadriplegia, microcephaly, seizure disorder, FX right tibia, gastrostromy, psychomotor retardation, spinal fusion 1988, blindness 1
0169122 04/25/2001 MA 28.0 28 F 03/23/2001 02/27/2001, vesicles noted with discomfort. On 3/3/01, vesicles dried. MD confirmation. Y 02/14/2001 02/27/2001 13 OTH PUB Too many to list, see attachments. NONE GERD; Encephalopathy, Seizures, Retardation, Esophagitis, Spinal fusion, Microcephaly, Spastic quad, legally blind, scoliosis, bilateral hip subluxation. 1
0169123 04/25/2001 MA 25.0 25 M 03/23/2001 Vesicles noted on 2/24/2001 with discomfort; areas fading and drying by 3/3/01. MD confirmation. Y 02/14/2001 02/24/2001 10 OTH PUB Too many to list; see attachments NONE Encephalopathy, seizures, cortical blindness, quadriplegia, absence of corpus callosum, osteoporosis, posterior spinal fusion with instrumentation 10-94, spastic quad. mental retardation, developmental delay, legally blind, S/P abductor myotomies. L/rib protuberance. 1
0169124 04/25/2001 OH 11.0 11 F 04/13/2001 With the first dose the pt experienced joint pain 24 hours post vax, with the 2nd dose, the pt experienced swelling face, neck. With the 3rd dose, the pt developed reddish, purple rash in lower legs 32 days later. 37 days post vax, the pt developed pain in legs was unable to walk, 41 days post vax, the pt developed edema in ankles and lower legs. Left eye had redness, pain, soreness and photophobia. Y N 02/20/2001 03/24/2001 32 PUB PUB asthma 1
0169129 04/25/2001 NY 4.0 4 F 04/20/2001 On 4/18/01 a phone call with Mom stated the left upper arm swollen, reddened. Motrin and Tylenol for pain and discomfort, cold compresses. Decreased swelling, to observe in 24 hours. Follow up with concerns. On 4/19/01 in office, redness and edema, sore to touch, a 10x10cm red area, a 5x5cm indurated area around upper vaccine puncture. Y Y 04/17/2001 04/18/2001 1 PVT PVT cough and runny nose 1
0169130 04/25/2001 TX 3.0 1 .0 M 04/18/2001 The pt developed varicella disease with 100-200 lesions. U 08/20/1998 04/18/2001 972 PVT PVT NONE NONE NONE 1
0169131 04/25/2001 WI 55.0 55 F The pt received the vaccine in the left deltoid on 4/16, on 4/18/ she noticed redness and itching at the site. The site measured 165 cm x 150 cm, was warm to the touch, red and hard. The pt was sent to "immediate care" for further evaluation. Y U 04/16/2001 04/18/2001 2 PUB OTH TB skin test seasonal allergies allergy to erythromycin 1
0169132 04/25/2001 CA 62.0 62 F 04/17/2001 The pt came to the clinic because of left upper arm redness, swelling, tenderness and hot to touch. Treated with compresses, Tylenol, Benadryl for itch. Y 04/10/2001 04/13/2001 3 OTH OTH NONE NONE NONE 1
0169133 04/25/2001 2.0 1 .1 F 04/09/2001 The pt experienced an onset of painful, pruritic rash in L2 dermatome of right leg, with vesicular eruption. No systemic symptoms. No known wild type varicella contact. Y U 02/09/2000 04/05/2001 421 MIL MIL NONE NONE NONE 1
0169134 04/25/2001 CA 4.0 3 F 04/16/2001 The pt experienced a maculo-vesicular rash scattered all over the body which started as few patches on chest and toes and gradually spreading in 2 days. Rashes crested and dried after 7 days. No associated fever. Y 03/10/2000 03/25/2001 380 PVT UNK 1
0169135 04/25/2001 MI U The pt experienced a fever 1 week prior to onset of rash. The pt developed red lesions - formed vesicles and scabs. Y 09/23/1998 04/05/2001 925 PVT PVT NONE 1
0169137 04/25/2001 WI 25.0 25 F 04/18/2001 The pt had been instructed at the time of MMR administration to prevent/avoid pregnancy for 3 months after receiving the vaccine. The pt unintentionally became pregnant. LMP 3/12/01, MMR given on 3/15/01. The pt had a positive pregnancy test on 4/16/01. Pt unsure of plans regarding pregnancy. The pt did not have an adverse reaction. U 03/15/2001 04/16/2001 32 OTH PUB NONE NONE NONE 1
0169138 04/25/2001 MA 4.0 4 F 04/14/2001 The pt experienced swelling, warmth and erythema to the right arm around the site of vaccination. Y U 04/11/2001 04/12/2001 1 PUB PUB NONE NONE NONE 1
0169139 04/25/2001 TX 54.0 54 F 04/12/2001 The pt experienced a localized redness, swelling to the entire upper left arm. the pt complained of nausea and body aches. Y Y 04/11/2001 04/11/2001 0 OTH MIL PPD 1
0169228 04/25/2001 NJ 3.0 3 F 12/12/2000 It was reported that a pt (1 of 2) received a Tripedia vaccination. Reportedly, sometime after the vaccination, the pt developed a large local reaction. No specifics were provided. From additional correspondence Received on 12/6/00, it was reported that the pt's local reaction consisted of a large hot area, the size of a small chicken egg. Reportedly, the pt recovered from this experience. Y Y 12/02/2000 NONE PVT PVT NONE NONE U2000009790 1
0169229 04/25/2001 NJ 4.0 4 M 12/12/2000 Subsequent to receiving vax, the pt developed a large local reaction. No specifics were provided. Additional correspondence received reports that the pts injection site reaction consisted of a large hot area that was the size of a small orange. Y U 12/02/2000 UNK PVT PVT Large swollen red area on arm, no where else. NONE U2000009800 1
0169230 04/25/2001 UT 0.8 0 .7 F 02/15/2001 Immediately post vax the pt developed a rash on her face - no respiratory distress. The rash faded within 30 minutes. Additional information received reported that the Tripedia was given in the right leg and the IPOL and Comvax were given in the left leg. No further information is expected. This case is closed. Y 12/05/2000 12/05/2000 0 PUB OTH NONE NONE screaming syndrome~DTaP (no brand name)~1~0.00~In Patient U2000009810 1
0169231 04/25/2001 VA 1.5 1 .5 F 01/27/2001 Subsequent to receiving vax, the pt experienced a local reaction characterized by an area of 3 cm of redness. 12/11/2000 UNK UNK U2001002590 1
0169232 04/25/2001 VA 1.6 1 .5 M 03/08/2001 Subsequent to receiving vax, the pt experienced a local reaction characterized by a 3 cm area of redness. Additional information received reports that the pt developed the local reaction on his left arm. Reportedly the pt recovered from this experience. Y 11/10/2000 11/11/2000 1 NONE PVT PVT NONE U2001002630 1
0169233 04/25/2001 FL 0.2 0 .2 F 01/27/2001 Subsequent to receiving vax, the pt experienced uncontrollable crying for about 3 hours. 12/14/2000 UNK UNK U2001002650 1
0169234 04/25/2001 MI 1.6 1 .6 F 02/09/2001 Subsequent to receiving vax, the pt developed a large local reaction at the injection site measuring 2.5 X 2.5 inches. Further information is requested. U 01/22/2001 UNK UNK U2001003770 1
0169237 04/25/2001 MI 2.0 2 .3 M 02/09/2001 Subsequent to receiving vax, the pt developed a large local reaction at the left thigh injection site that measured 2 X 3 inches. Further information is requested. U 01/22/2001 UNK UNK U2001003800 1
0169238 04/25/2001 VA 4.0 4 M 02/14/2001 One day post vax, the pt developed a local reaction of redness and swelling. Further information is requested. Y 01/30/2001 01/31/2001 1 UNK UNK U2001004080 1
0169048 04/26/2001 NM 33.0 31 F 04/19/2001 This patient has an extreme rash within one week. (Ob/Gyn Prescribed Lidex). She had joint pain, started in her fingers, and feet within 2 weeks. Thereafter diagnosed with "seronegative inflammatory arthritis" in the active stage. Currently on Methotrexate, Celebrex, and Arava. Y N 09/28/1999 10/20/1999 22 PVT OTH Pregnancy (2 days after delivery). NONE 1
0169049 04/26/2001 IN 13.0 13 M 04/17/2001 The pt experienced a rash, erythema, pruritus at the site of injection, hypertension, nausea, vomiting, pallor, weakness. Treated with Allegra, Pepcid, Epinephrine, Medrol Dose Pak, and IV Fluids. Y Y Y 04/16/2001 04/16/2001 0 CBC, Chem 7 - results elevated WBC, decreased KT. PVT PVT NONE NONE allergy to codeine, Zithromax, pertussis vaccine Edema in 1987~Pertussis (no brand name)~1~0.20~In Patient 1
0169050 04/26/2001 AZ 1.08 1 .1 M 04/17/2001 This infant was seen in the clinic on 03/28/01, diagnosed with bilateral otitis media. He was also given DTaP #4, IPV #3, Hib #4, Varivax, and PCV #1. Seen on 04/13/01 with petechiae, platelet count <1, diagnosed with Idiopathic Thrombocytopenic Purpura, hospitalized for 3 days, IVIG Win-Rho. Also diagnosed with anemia. Mom states on 05/09/2001 that child is recovered from her point of view, scratches are healing okay Y 3 Y 03/28/2001 04/13/2001 16 Lab tests. PUB PUB Augmentin otitis media asthma 1
0169051 04/26/2001 IL 0.75 0 .8 M 04/19/2001 Dry cough began on 4/15/01. Pt seen on 4/16/01 and Prevnar given. On 4/16/01 PM, pt had increased difficulty breathing. He was hospitalized on 4/17/01 and required transport to PICU on 4/17/01 for heliox treatment. Diagnosed with viral pneumonia. Y 4 Y 04/16/2001 04/16/2001 0 CXR-right perihilar and right lower lobe pneumonia PVT PVT NONE NONE NONE 1
0169052 04/26/2001 FL 0.5 0 .5 F 08/30/2002 A sales representative reported that a 9 month old developed "strep. pneumonia meningitis" approx. 3 months after the 2nd dose of Prevnar. The child had a recent medical history of otitis media. The sales representative stated that he was "pretty" certain that the child was hospitalized. The reporter indicated that a physician specializing in Pediatric Infectious Diseases performed lab, blood, titer and serotyping and the child reportedly was positive for 1 of the 7 serotypes contained in Prevnar. He stated that the healthcare provider indicated that the child was very ill with a poor prognosis. F/U info rec'd 6/11/01 indicated that blood cultures and lumbar puncture were performed both were positive for Strep pneumo. The reporter idicated that the pt had not recovered and was now disabled. Upon review on 9/22/01, this event is reclssified as expected. Y Y N 11/30/2000 02/28/2001 90 Lab, blood, titer and serotyping-positive for 1 of the 7 serotypes contained in Prevnar. F/U 6/11/01 blood culture and LP were performed. blood and cerebrospinal fluid cultures were positive for Strep pneumo. PVT OTH NONE UNK otitis media HQ9888219APR2001 1
0169090 04/26/2001 PA 6.0 1 .0 M 04/17/2001 This patient was exposed to his sibling with the chicken pox on 03/31/01, 30 - 40 lesions on his trunk, extremities and mouth. Afebrile. Y 03/07/1996 04/14/2001 1864 NONE PVT PVT Tine (Monovacc), Connaught, lot # K1132-2, sub Q left forearm. Right otitis media 03/02/96. History of otitis media. 1
0169106 04/26/2001 FL 29.0 29 F 04/18/2001 This patient received yellow fever injection at 9:15 AM, symptoms occurred at 9:45 AM. The patient was sent to the ER with flushing, itching, dyspnea, nasal-ocular systems, burning skin. Y Y 03/16/2001 03/16/2001 0 MIL MIL NONE Narcotics sensitivity, and aeroallergens. 1
0169107 04/26/2001 IL 7.0 3 M 03/10/2001 This child received Varivax 03/12/97. He had the chicken pox outbreak starting 03/02/01. Approximately 25 lesions. U 03/12/1997 03/02/2001 1451 PVT UNK NONE NONE 1
0169108 04/26/2001 PA 1.0 1 .0 F 04/10/2001 This patient was given Varivax on 03/09/01 in the right thigh. On 03/22/01, the youngster erupted vesicular rash on the right leg. She had multiple small vesicular / papular covered right knee,thigh; patches vesicular papular over the abdomen, right lower leg. Vesicular erupted both hands and feet. Acyclovir on 04/11/01. Lesions began to resolve by 04/15/01. The follow up received on 5/18/01 states rash has since been diagnosed as papular acrodermatitis of childhood (Gianotti-Crosti syndrome). Y 03/09/2001 03/22/2001 13 NONE PVT PVT NONE NONE NONE 1
0169114 04/26/2001 OH 5.0 1 .1 F 04/16/2001 This child developed varicella lesions on 04/10/01. Y Y 10/17/1996 04/10/2001 1636 PVT PVT NONE NONE NONE 1
0169125 04/26/2001 MO 6.0 1 .0 F No data. U 12/01/1995 04/16/2001 1963 PVT UNK NONE 1
0169126 04/26/2001 AL 4.0 4 F 04/18/2001 A questionable rash s/p immunization within 24 hours, mild swelling of her toes, fingers, and hands with erythema. No fever, no local site reaction; no vomiting. Questions being stung by an insect on the left 2nd great toes. Meds yesterday, Tylenol. Y Y 04/17/2001 04/18/2001 1 UA - trace blood, otherwise neg. PVT UNK Tylenol mild nasal congestion NONE 1
0169127 04/26/2001 OH 1.5 1 .5 M 04/19/2001 This infant had erythema and induration (2x1.5 cm). U 04/05/2001 04/18/2001 13 PVT UNK Bilateral otitis media, Sinusitis NONE 1
0169128 04/26/2001 RI 1.0 1 .1 M 04/20/2001 This infant had scattered red papules, some vesicular, some excoriated on the chest, back, face, and ears. Y 04/09/2001 04/16/2001 7 PVT PUB NONE Allergic to Augmentin 01/28/01. 1
0169136 04/26/2001 MD 1.25 1 .3 M 04/19/2001 This patient had local swelling at the injection site on the right arm (DTaP / HIB). He had a fever of 102 for 48 hours. Y 04/13/2001 04/14/2001 1 NONE PVT PVT NONE NONE 1
0169211 04/26/2001 OH 1.6 1 .6 M 04/19/2001 This infant had vaccine administered on 04/09/01. On 04/11/01, he presents with right arm edema at the injection site down to the wrist. The patient was seen by the doctor at the health center. Y U 04/09/2001 04/11/2001 2 PUB PUB NONE NONE NONE 1
0169212 04/26/2001 CA 1.5 1 .5 M 04/24/2001 This infant developed a fever and a rash; erythema multiforme. U 04/18/2001 04/19/2001 1 PUB PUB Tylenol, Flouride. NONE NONE 1
0169213 04/26/2001 CA 1.0 1 .5 F 04/17/2001 This infant had swelling of the face consistent with allergic reaction approximately 16 hours after receiving her vaccine. She was given Benadryl. U 04/18/2001 04/19/2001 1 PVT PUB NONE NONE 1
0169214 04/26/2001 GA 0.75 0 .8 F 04/20/2001 On 04/19/01 in the PM, this patient's mother called reporting the patient had a 103 temp, no other sicknesses; although pulling at her ears. The patient was seen in the office on 04/20/01 at 10:30 and no otitis media was evident. Y 04/16/2001 04/19/2001 3 PVT PVT NONE History of cleft lip, s/p repair 10/24/00. 1
0169215 04/26/2001 VA 1.25 1 .3 M 04/18/2001 On 04/17/01 at 8:30 PM, the mother noted a temp of 100.5, at 9:15 PM seizure one, time and vomiting twice. On 04/18/01 at 4:00 AM, patient had a temp of 103.9, difficulty breathing; resolved with nebulizer treatment. T 8:30 AM, the patient was seen in the clinic with a temp of 101. On 04/20/01, the patient had a recheck in the clinic, the temp was elevated to 103 on 04/19; no seizure. The patient was referred for a neuro work up. Y U 04/17/2001 04/17/2001 0 CBC within Normal limits. Chest x-ray - Normal. PVT PVT NONE Asthma, history of febrile seizure. 1
0169216 04/26/2001 MI 1.25 1 .3 M 04/12/2001 The mother states that this child had a seizure at 1:30 AM, and states the child felt warm to touch. He had a 2nd seizure at 6:30 AM, his temp was 102 (ax). At 7:30 the child was taken to the hospital, the temp was 103 (rect), he was given Motrin, Blood work was done. He had a 3rd seizure at 2 PM some day 04/03/01 none since. The patient was in the clinic on 04/12/01 to inform of the seizure activity with the child. Y Y 04/02/2001 04/03/2001 1 Blood work done - results unknown 04/12/01. PUB PUB NONE History of pneumonia in March. 1
0169217 04/26/2001 IL 0.8 0 .9 M 04/20/2001 Prevnar 1st dose given on 04/17/01, IPV 3rd dose given on 04/17/01, Hep B 3rd dose given on 04/17/01. On 04/18/01, in the Am, the child had pinpoint erythematous rash, irritable, restless, scratching. No hives, no fever, no wheezing. On 04/19/01, the patient was seen in the office, rash on the neck, torso, arms, legs,and diaper area. On 04/19/01, Benadryl was given. U 04/17/2001 04/18/2001 1 PVT UNK NONE NONE 1
0169218 04/26/2001 ID 1.8 1 .7 M 04/16/2001 This infant had a fever with inconsolability for 5 days after his injection (described by his mother- did not bring the child in during this time). Y 03/24/2001 03/24/2001 0 NONE PVT PUB Septra Resolved bilateral otitis media NONE 1
0169219 04/26/2001 VA 4 F 04/20/2001 This patient complained of rash (approximately 10 lesions) which developed a blister which scabbed over. U 07/08/1996 04/07/2001 1734 NONE PVT PVT NONE 1
0169220 04/26/2001 AZ 6.0 6 F 04/18/2001 This child had erythema in the left arm at the site of injection given on 04/16. In 24 hours it developed erythematous tender area, cellulitis versus local reaction. N 04/16/2001 04/17/2001 1 PVT PVT NONE 1
0169222 04/26/2001 MO 1.5 1 .5 F 04/25/2001 This infant had a 9 x 10 cm erythematous, warm macular area with central clearing to the feet and upper thigh. Recommended treatment of Aveeno bath and Benadryl for 2 days, then as needed. Y Y 04/18/2001 04/19/2001 1 PVT PVT NONE NONE NONE 1
0169223 04/26/2001 MA 18.0 18 F 04/19/2001 This patient developed body aches, left arm ache, multiple swollen glands, left clavicular , left anterior cervical. No axillary nodes. The patient incapacitated by arm pain 1 day, slowly improved over 3 days. Y Y 04/09/2001 04/10/2001 1 NONE PVT PVT NONE NONE Sulfa - hives. Had a T & A (tonsillectomy and adenoidectomy) in 1997. 1
0169224 04/26/2001 MA 1.25 1 .3 M 03/30/2001 This infant had a fever of 103 in one ear and 105 in the other ear. He had a febrile seizure (star mode) 10-15 minutes. The baby was rushed to the ER. Return to his doctor the next day had a reaction to the shots. Y Y 02/07/2001 02/16/2001 9 PVT UNK NONE NONE NONE 1
0169225 04/26/2001 TX 1.3 1 .3 M 04/09/2001 This infant had a high fever of 103 beginning 9 days after his MMR, lasted 48 hours. Probable febrile seizure x 2. He broke out into a rash 12 days after the vaccine it lasted 24 hours. Y 03/13/2001 03/22/2001 9 MIL MIL NONE NONE NONE 1
0169226 04/26/2001 ND 19.0 19 M 04/17/2001 A Tetanus-Diptheria vaccine was administered on 03/27/01. The mother phoned into the office on 03/29/01 stating that the patient had experienced a deep aching pain in the left arm along with diarrhea, vomiting, temp, and chills on 03/27/01. The patient referred to physician. Y 03/27/2001 03/27/2001 0 PUB PUB NONE NONE ND0103 1
0169227 04/26/2001 TX 14.0 14 F 04/18/2001 Within 30 minutes after Hep B #2 vaccine, the patient developed frontal headache, epigastric pain, and nausea, no emesis. History of the same symptoms after the flu vaccine 3 years ago. Y 04/18/2001 04/18/2001 0 NONE PUB PUB Dizziness in the AM. Headache, epigastric pain, and nausea.~Influenza (Seasonal) (no brand name)~1~11.00~In Patient 1
0169143 04/27/2001 PA 0.3 0 .3 F 04/26/2001 Pt was hospitalized and dx'd with bacterial meningitis. This occurred 10 days after receiving the new Prevnar vaccine. Symptoms included fever, vomiting and stiff neck. Pt was given various antibiotics for 14 days. Tests conducted on the cultures were unable to determine the exact strain of meningitis. Y Y Y 10 Y 02/23/2001 03/06/2001 11 Cultures PVT PVT NONE NONE NONE 1
0169144 04/27/2001 PA 0.25 0 .3 F 04/17/2001 My daughter received the shot of Prevnar on Tuesday evening. Wednesday she was fine all day until 6:45 PM. She woke up from a nap barely able to cry, when I picked her up she had thick mucus coming from her nose and mouth. As I had her on her side trying to suction it out of her mouth, she went limp and stopped breathing. About a minute later she was gasping for air while we waited for the ambulance to arrive. Her breathing was very shallow and she did vomit mucus. At the hospital she was hooked up to watch her heart and oxygen level, while she was being checked she vomited a lot of mucus again. They took x-rays of her chest to check her lungs which were clear. They sent us to another hospital with a pediatric ward. Once there they drew blood and also watched her heart rate and oxygen level which was at 100%. She had tests done for apnea and acid reflux which were all negative. The only test that came back positive was for RSV. Since her release from the hospital on the 13th, I have found out there were two more incidents identical to my daughters in our home town alone. Both had occurred within 24 hours of receiving Prevnar shot. I have also contacted the hospital in which our daughter and one other baby had gone to let them know of this possible connection and was told there has been numerous cases of RSV lately with infants. They said they are going to contact the doctors of those patient's to see if Prevnar was given prior to them being rushed to the hospital with breathing difficulties. I can only say from my own experience I am glad this happened before we went to bed for the night, my daughter probably would not be here with us right now. If there is a problem with this shot, I can only hope to warn others to monitor their babies closely. Y Y U 04/10/2001 04/11/2001 1 She had test done for apnea and acid reflux all Neg. Blood work. Positive for RSV. UNK UNK NONE 1
0169148 04/27/2001 TX 1.3 1 .4 M 04/02/2001 On 03/29/01 father of child returned with patient for trouble breathing. He reported to a nurse that on 03/28/01 approximately 1:00 AM, the child began with seizures and the EMS was called. Transported to the ER released later. Give Motrin and Tylenol, and see PCP. The PCP was seen later that day with same treatment for the fever. On 03/30/01, child report having fever of 101, treatment being followed. On 04/02/01 the child was afebrile, no other symptoms reported. Y Y 03/27/2001 03/28/2001 1 CBC with Diff & Metabolic Panel - nothing remarkable. PUB OTH NONE NONE SA0104 1
0169149 04/27/2001 NY 3.0 3 M 04/27/2001 On 4/23/01 the pt experienced 5cm x 3cm wheal at the injection site. On 4/24/01, there were erythematous areas surroudning ears and cheeks the left greater than the right. The injection site had a 6cm round indurated erythematous area. The pt had a temp of 100 axillary, treated with Motrin. On 4/25/01 the injection site was still induratied with redness, Motrin given again. Face and ears had rash. On 4/26/01 the injection had grown to 10cm round, was hot, indurated and had a hematoma. U 04/23/2001 04/23/2001 0 PVT PVT NONE NONE NONE 1
0169150 04/27/2001 FL 0.75 0 .8 F 04/23/2001 This infant had a little knot with redness. Y 04/21/2001 04/22/2001 1 NONE PVT UNK URI 1
0169151 04/27/2001 MS 0.2 0 .2 M 04/19/2001 On 04/13/01, this patient's mother called at 12:30 stating the infant hadn't stopped crying since he was given the immunization 04/12/01. No fever or rash, gave the infant Tylenol. She couldn't see what was causing him to cry, no transportation to bring him to the MD. The mother promised to carry him to the PMD. The grandmother noted his left thigh was swollen and the infant's thigh was rubbed with alcohol and he stopped crying. The infant was not carried to the PMD and as of 04/19/01, no other problems. Y 04/12/2001 04/12/2001 0 PUB PUB NONE NONE NONE MS01012 1
0169152 04/27/2001 NC 0.75 0 .8 M 04/20/2001 Pt developed induration, erythema and warmth about the size of a 50 cent piece. Y 04/19/2001 04/19/2001 0 PVT PVT NONE 1
0169153 04/27/2001 FL 32.0 32 M 04/17/2001 This patient received a vaccine on 04/13/01, he developed a large bruise to the site of injection. Cellulitis extends from the site of the injection to below the elbow. The patient was treated with Augmentin for 10 days, Motrin as needed for the pain, and warm compress to the site. Y Y 04/15/2001 NONE MIL MIL NONE NONE 1
0169154 04/27/2001 MD 57.0 56 F 04/24/2001 Report 2001010092-1 described rheumatoid arthritis and deep vein thrombosis in the leg in a 57 year old female who received Lyme disease vaccine recombinant OspA (Lymerix) for the prevention of Lyme disease. This report was received from the vaccinee's spouse and has been verified by the PCP and medical records from a rheumatologist. The vaccinee had no known allergies. Her medical history included colitis and stomach problems (NOS) every four to five months. She received estrogens conjugated / medroxyprogesterone acetate (Prempro). ON May 25, 1999 and on June 22, 1999, the vaccinee received her 1st and 2nd doses of Lymerix, respectively. Approximately six to eight weeks after receiving the 2nd dose of Lymerix (in August or Sept 1999), the vaccinee experienced a swollen left wrist. MRI, x-ray (NOS), and labs including erythrocyte sedimentation rate and C-reactive protein were performed. The vaccinee was told that her diagnosis was "inflammation". Her left wrist remained swollen for several months. In the spring 2000, the vaccinee's left knee swelled. The joint swelling then shifted to the right knee and then back to the left knee. Joint fluid was obtained three times. It "showed nothing" The vaccinee was seen by several physician's and, subsequently, more lab tests were performed. Rheumatoid factor was found to be positive. At no time did any of the vaccinee's physician's suggest a link between her symptoms and Lymerix. In August 2000, the vaccinee developed a blood clot in the leg which was treated with warfarin sodium (Coumadin). As of 04/20/01, the joint swelling and inflammation were resolved. The outcome of the blood clot was not specified. The adverse events of "joint swelling' and "joint inflammation" do not meet ICH serious criteria, but are being submitted as an expedited report by special FDA request per the June 28, 2000 letter. Per F/U, rheumatologist medical record of 3/21/00 states that in 9/99, while working on some stained glass, the pt noticed a "pop" and swelling in the left wrist. She has had significant pain since that time but that it has gradually progressed and she was left more with stiffness. On 5/10/01, the pt's PCP reported that the pt's rheumatoid arthritis began on 9/1/99, when she developed swelling and redness to the left wrist. In 11/99, the pt noticed muscle loss in the forearms. X-rays showed bone loss and MRI showed inflammation. The left hand only, pronated and supinated approx. 80 degrees. She had 20 degrees of left wrist extension and 30 degrees of flexion. The wrist was warm, swollen and tender on palpation. There was swelling over the dorsum of the left, less prominant over the volar aspect. There was significant and advanced atrophy of the left forearm musculature. Assessment: monoarthritis affecting the left wrist. The pt developed bilateral knee pain and swelling with resolution of the right knee inflammation when a physician aspirated and injected the knee with steroid (NOS). She had the left knee aspirated but not injected and it did not improve until it was aspirated again and injected with steroid (NOS). She had fallen off her bike and injuured the left wrist. The pt's ESR was running in the 30's to 50's. Assessment: We are probably looking at the early onset of rhematoid arthritis. Celebres 200mg 1 twice daily orally was prescribed. At some later date, the physician prescribed hydroxychloroquine (Plaquenil). The pt telephones the physician on an unspecified date and stated that she had been having a rash where she sweated and her ankle and wrist were swollen. The physician held Plaquenil. On 8/24/00, the pt developed a deep vein thrombosis in the leg which was treated with warfarin sodium (Coumadin). This resolved in 6 months. The pt reported severe abdominal bloating and had to stop the Plaquenil. Her exam showed active synovitis in the left wrist and right knee with swelling and pain. On 2/01, Plaquenil 200mg 1 po twice daily was re-prescribed. On 4/6/01, the pt developed borderline hypertension. The PCP stated the rheumatoid arthritis was possibly related to Lymerix and also that the adverse events could be associated with PremPro therapy. Y N 06/22/1999 09/01/1999 71 ESR - 0 Result text: "inflammation". CRP - 0 Result text: "inflammation". RF - 0 Result text: positive. Joint Fluid - Result text: X3 "Showed Nothing". X-Ray (NOS) - Result text: "Inflammation". MRI - Result text: "Inflammation"; X-rays-showed bone loss; MRI-showed inflammation; 12/7/99 lab-shows ESR-37mm/hr; CBC-nml; serum protein electrophoresis-nml OTH OTH Prempro Colitis; Peptic Ulcer disease 30 to 40 years ago and had an appendectomy; Tick exposure and regulary pulled them off her skin; her mother had deformed hands bilaterally which came on as she got older. 20010100921 1
0169155 04/27/2001 NC 40.0 50 F 10/09/2001 Report 2001010237-1 describes migratory joint discomfort in a 40 year old female who received Lyme disease vaccine recombinant OspA (Lymerix). Medical history included "many somatic complaints". Concurrent medications were not specified. The patient received two injections of Lymerix on unspecified dates. At some later time, she experienced migratory joint discomfort. As of 04/24/01, the joint discomfort had persisted for several months and was ongoing. The reporting physician considered the joint discomfort to be "probably not related" to Lymerix administration. The adverse event of migratory joint discomfort does not meet ICH serious criteria, but is being submitted as an expedited report by report by special FDA request per the June 28, 2000 letter. On 08/02/2001, additional info was received from a different physician within the initial reporter's group. The second physician did not confirm the occurrence of migratory joint discomfort. The second physician reproted that on 04/29/1999, the pt experienced chills, fever and myalgias. These events were of moderate intensity. No laboratory evaluations were performed. The chills, fever, and myalgias resovlved after an unspecified period of time. the second physician considered the chills, fever, and myalgias to be possibly related to LYMErix administration, and the immunization series was discontinued. The follow up states that the additional info was received from another physician within the same medical group. Medical history also included osteoarthritis. The pt had no known drug allergies. There were no concurrent medications. The initial reporter stated that the patient received one injection of LYMErix on 04/28/1999. On 08/02/2001, additional info was received from a different physician within the initial reporter's group. The second physician did not confirm the occurrence of migratory joint discomfort. The second physician reported that, on 04/29/1999, the pt experienced chills, fever and myalgias. These events were of moderate intensity. No laboratory evaluations were performed. The chills, fever, and myalgias resolved after an unspecified period of time. The second physician considered the chills, fever, and myalgias to be possibly related to LYMErix administration, and te immunization series was discontinued. Y N 04/28/1999 04/29/1999 1 OTH OTH NONE NONE History of "many somatic complaints"., osteoarthritis 20010102371 1
0169156 04/27/2001 MI 1.5 1 .5 M 04/21/2001 This infant had a 2 inch diameter reaction around the area of DTaP. Warm to touch. Giving him Motrin and cool compresses to the area, left thigh. On Augmentin for 2 weeks for Serous Otitis Media. Started 04/18/01. Y 04/18/2001 04/18/2001 0 NONE PVT PVT NONE URI, bilateral serous otitis media. 1
0169157 04/27/2001 WA 1.5 1 .6 M 04/17/2001 A child received Varivax at 18 months of age. At 7 yrs and 3 mos, he developed a mild distinct case of chicken pox precisely 14 days post-exposure to a classmate who developed varicella. Y 08/15/1995 04/15/2001 2070 PVT OTH NONE NONE Penicillin related rash. 1
0169158 04/27/2001 VA 5.0 5 M 04/20/2001 This child had varicella begin on 04/18/01, only 12 lesions. He had Varivax vaccine 08/25/00, failed vaccine. U 08/25/2000 04/18/2001 236 NONE PVT PVT NONE 1
0169159 04/27/2001 CA 5.0 5 F 04/19/2001 10 minutes after immunization was given, as the patient was leaving the examining room, she turned around and started seizing and fell down. The seizure lasted less than 30 seconds. The patient recovered completely. Y 04/19/2001 04/19/2001 0 NONE PVT PVT NONE NONE NONE 1
0169160 04/27/2001 MD 41.0 41 F 04/23/2001 This patient received MMR at their primary physicians office on 03/09/01 (after neg mump titer). By 03/28/01, she noted right node by both, right jaw / neck very swollen, she had a low grade temp, intense facial pain with spasms, especially after eating. The symptoms gradually went away in 10 days. Fatigue lasted 10 days. Diagnosed with Mumps disease Y 03/09/2001 03/28/2001 19 Mumps Titer 320 on 4/02/2001. PVT PVT Nasocort NONE Exercise induced asthma, chronic rhinitis. 1
0169161 04/27/2001 MI 0.5 0 .5 M 04/20/2001 This infant had localized erythema, swelling,and a papular rash. Treated with oral Benadryl. U 04/18/2001 04/18/2001 0 PVT PUB Zithromax Otitis Media. 1
0169162 04/27/2001 CA 32 F 04/25/2001 This patient had swollen cervical and occipital lymph glands, fever, and myalgias. U 04/13/2001 04/20/2001 7 OTH OTH NONE NONE 1
0169163 04/27/2001 MD 75.0 75 U After my physical exam last Monday, March 12, she was given Pneumovax injection, a vaccine against bacterial pneumonia, about 3 PM. The person who gave her the shot and I talked jovially about the side effects which were dismissed as basically nil. About 5 PM the same day, only two hours after the shot, I began to experience malarial chills, (These were similar to malaria which I had when I was 11). These became worse as the evening wore on. So I had a warm bath and went to bed a little earlier than usual. But my sleep was extremely disturbed. The next day, Tuesday, was even worse. The chills started again, then petered out and started again. By noon I had to take a noon nap. This is extremely rare for me. My normal energetic self had been changed into a slowly walking exhausted and sick man; just as the same as when I returned from overseas several years ago. I had fish poisoning on the eve of my departure. The flight back took 14 hours flying with diarrhea all the way, waited for the connections to Washington. I walked off the plane looking ghastly sick. That's what my wife said I looked like on Tuesday last. I literally dragged myself around all day. On Wednesday, I had recovered 95%. My reaction to the vaccine was absolutely horrendous for 36 hours. Please include this report in my medical record and, in all fairness to others, the FDA should also be notified of this reaction. I wish I had been told that there may be this kind of reaction to the vaccine. May I hear from you about this matter? Y 03/12/2001 03/12/2001 0 PVT OTH NONE NONE 1
0169242 04/30/2001 NY 5.0 5 M 04/09/2001 It was reported that a 5 year-old male patient received IPOL and a Tripedia vaccination on 03/29/2001. Reportedly, the next day the patient developed a fever of 102 F and lethargy. One week later, he dedveloped sinusitis and a reccurrence of ITP (Idiopathic thrombocytopenic purpura). From FOLLOW-UP telephone contact on 08/15/2001 with vaccinatin physician it was stated that the patient received a DTP vaccination in 1977 (Tetramune) and developed ITP a couple weeks later. After the resolution of the ITP platelets counts were discontinued "On 03/29/2001, (patient) was given a DAPT vaccine in the left arm He developed bruises and a platelet count on 04/05/2001 was 55,000. He was again followed by Hospital and platelet counts have since returned to normal without treatment. Y 03/29/2001 03/30/2001 1 UNK UNK U2001006001 1
0169244 04/30/2001 NJ 8.0 F 04/26/2001 This child had viral infection, rigid muscles, severe headache, weakness, streptococcal throat, allergies, and head cold. An initial report was received from an 8 year old female patient's mother. She said her daughter was hospitalized on 06/12/00 for meningitis and septicemia following postexposure to RabAvert administration. According to the patient's mother, the patient received a complete postexposue series including 5 doses of RabAvert and human rabies immune globulin. The first 4 doses of RabAvert were from lot# 233011 (dates unknown), and the fifth dose of RabAvert was from lot # 261011 (lot recalled because of some cracked vials). The 5th dose of RabAvert was given on 05/26/00. According to the mother, on 06/2/00, the patient was admitted tot he hospital with rigid muscles, a severe headache, and weakness (she could not stand). She was diagnosed with meningitis and septicemia. The patient was hospitalized for 4 days and received antibiotics and IV fluids. During the hospitalization, she underwent a number of tests including a lumbar puncture to determine the cause of the meningitis and septicemia. An exotic disease specialist also saw her; however, the cause was not determined. The mother reported that, prior to this event, the patient was a healthy child. Following the event, the patient's health had been poor. She had streptococcal throat three times in the last year, and had lots of allergies which she did not have prior to this event. According to the mother, the patient's immune system had not recovered. The mother said she had also discussed this event with the pharmacist at the hospital, as well as the patient's pediatrician. She was concerned that this event might have occurred secondary to the administration of the recalled RabAvert. The mother reported that the child's pediatrician had relayed to her that he did not think that the meningitis was related to the recalled RabAvert. Follow up info was received on 04/24/01 from the patient's pediatrician. According to the pediatrician, the patient was admitted to the hospital with symptoms suggestive of possible meningitis. An infectious disease consultant was called and many studies were performed to rule-out meningitis and septicemia. There was no concrete evidence of meningitis. The lumbar puncture was negative, "it didn't look bacterial or viral". Culture were negative. There was a borderline elevation of IgG (=64) for Rocky Mountain Spotted Fever, suggestive of questionable past infection. The lyme disease index on cerebral spinal fluid was 1:3, (borderline elevated), but other lyme test were negative. The pediatrician's opinion was that if the tests were not clear, they were essentially negative. The patient's throat "looked bad", so empirically the pediatrician treated her with Penicillin and she got better. He thought that the symptoms were most likely a viral infection, and still thinks so. On follow up, the patient "was OK. Her mother thought she was never right, but there's nothing that a doctor would think there was anything wrong." The pediatrician thought the patient was well, and had recovered. She had a couple of head colds and streptococcal throat, and the pediatrician did not think this was anything out of the ordinary for an 8 year old. The pediatrician did not have any information on the rabies vaccine which was given at the hospital, or the lot numbers. He was told that the patient had a dog bite. The pediatrician thought that the patient did not have any alteration in her immune system, and that "her symptoms added up to infection, but all the studies came up negative. There was no clinical correlation with any findings. No encephalic pattern, nothing to suggest infection, toxin, or any vaccine related effect in this case. No sign of encephalitis or meningitis. If it was a vaccine effect, there might be encephalitis or meningitis." The pediatrician stated that June was usually a prime month for conditions of encephalitis going around in the community, but he did not specifically remember whether there was any disease with symptoms like those seen in this case prevalent in the community at the time of the patient's hospitalization. The pediatrician said, when directly questioned by the Drug Safety physician, that he did not think the patient had meningitis, septicemia, or immune dysfunction, and did not think that any of the adverse events were related to RabAvert. Y 4 Y 05/26/2000 06/12/2000 17 The lumbar puncture was negative, "it didn't look bacterial or viral". Culture were negative. There was a borderline elevation of IgG (=64) for Rocky Mountain Spotted Fever, suggestive of questionable past infection. The lyme disease index on cerebral spinal fluid was 1:3, (borderline elevated), but other lyme test were negative. PVT OTH Rabies immune globulin, Human UNK Dog bite, contact with or exposure to rabies. EM20010520 1
0169245 04/30/2001 IL 3.0 1 .0 M 04/21/2001 Autism, PDD Y N 04/03/1999 04/05/1999 2 PVT UNK 1
0169246 04/30/2001 VT 57.0 57 F 04/24/2001 The pt experienced an adverse reaction after receiving the tetanus and diphtheria adsorbed vaccine which included acute swelling, red blotches, internal bleeding and deep pain. It progressed to loss of feeling 90% in pt's arm. Y N 02/17/2001 02/17/2001 0 MRI - right upper extremity - probably myositis and inflammatory response involving deltoid muscle UNK UNK Paxil 1
0169247 04/30/2001 IN 7.0 M 04/18/2001 A report received from a health professional on 04/09/01 concerning a 7 year old, male patient who experienced flu-like symptoms, severe nausea, vomiting, and lethargy one day after receiving the Fluvirin vaccine, IM on 03/01/01, which led to hospitalization. The patient has a relevant medical history of sickle cell disease. The patient received a dose of Prevnar concomitantly. On 03/02/01, the patient experienced a syndrome of events including flu-like symptoms, sever nausea, vomiting, and lethargy for the duration of one week. The patient was not fully ambulatory and required inpatient hospitalization. The reporter was unsure of the duration of hospitalization. The patient was eventually discharged without further complications. After this adverse experience the physician noticed that his current stock of Fluvirin vaccines had partially crystallized. The reporter noted that the storage temp was 33 degrees F, below the recommended 36-46 degrees F for this product. It was recommended that the remainder of the physician's stock be discarded. There was insufficient info to determine the causality assessment of the reporter. Y Y 03/01/2001 03/02/2001 1 OTH OTH Prevnar was also given, no date provided sickle cell disease FLU8APR 1
0169249 04/30/2001 MI 1.3 1 .3 F 04/20/2001 On 4/19/01 at 2:00pm following a nap the mom noticed a red, hard, hot area on the left upper lateral thigh, approximately the size of a "golf ball". Applied warm compresses and soaked in a warm tub. On 4/20/01 in the AM the hard, reddened and hot to the touch area is progressively getting larger measuring 5 1/2 x 4 inches on pt's left thigh. U 04/18/2001 04/19/2001 1 PVT PUB NONE NONE 1
0169250 04/30/2001 MS 4.0 4 F 04/23/2001 The mother states the child lips were swelling and started at 8:00PM after the shots were given at 2:30PM. Mother gave the child Benadryl and the swelling decreased. No other problems noted. Mother denies the child was eating anything unusual. Y 04/19/2001 04/19/2001 0 NONE PUB OTH NONE NONE NONE 1
0169251 04/30/2001 MA 3.0 3 M 03/27/2001 Child developed hives, 24 hours, post vax. Y Y 03/23/2001 03/24/2001 1 PVT PUB NONE NONE Milk allergy 1
0169252 04/30/2001 MS 1.4 1 .4 M 04/16/2001 Pt had global urticarial rash with flushing and mild, coarse expiratory wheezes and noisy breathing. Given Epinephrine and Benadryl. Y 04/16/2001 04/16/2001 0 PVT PUB Chronic otitis media with effusion MS01013 1
0169253 04/30/2001 NC 1.25 1 .3 F 04/20/2001 Mom states pt broke out in hives, some on stomach, arms and face. Brought back in office at 16:10 to recheck and only had a little red spot on cheek. Did not last over 1 1/2 hours. Benadryl given. Y 04/03/2001 04/03/2001 0 NONE PVT PVT Gave acetaminophen, prior to shot. NONE NC01046 1
0169254 04/30/2001 NE 4.0 6 F 04/13/2001 High fever of 103F-104F(R) with unusual movements. Questionable myoclonic jerks. Y 04/02/2001 04/02/2001 0 NONE PVT UNK NONE 1
0169255 04/30/2001 PA 1.6 1 .7 M Left thigh with area of redness and swelling. Pt seen surround vaccine site. No streaking on 4/26/01 at 13:35. Local reaction to vaccine. Local care with cool compresses. Y U 04/24/2001 04/24/2001 0 NONE PVT PUB NONE Right and left ears red Has appt. for myringotomy on 5/1/01 1
0169256 04/30/2001 OH 8.0 8 M 03/28/2001 3/28/01 at 08:30, father called and stated that pt was complaining of itchy neck at bedtime and woke this AM with red spots all over his body, itching, no fever, no difficulty breathing. Advised to call his doctor. On 4/2/01, father returned calls. Child to ER on 3/30/01 and put on prednisone. Back to school on 4/2/01. Dx'd with hives. Y Y 03/27/2001 03/27/2001 0 PUB PUB NONE NONE OH0016 1
0169257 04/30/2001 OH 4.0 4 F 04/05/2001 2 days, post vax, child developed a fever of 103F, fatigue, leg aches, mild tongue swelling and a whoop-like cough, lasting 3 days. Did no go to physician for evaluation. Mother reports that these symptoms began on 3/23/01. She reported to health dept. this reaction on 4/5/01. Y 03/21/2001 03/23/2001 2 PUB PUB NONE NONE NONE OH0015 1
0169258 04/30/2001 OH 3.0 3 M 03/19/2001 On 3/15/01, vaccines were given. On 3/16/01, left thigh was warm and red. On 3/17/01 and 3/18/01, leg continued to be red, despite mom's efforts with Benadryl cream. She contacted physician. No other symptoms. On 3/17/01, brought back child to H D to show redness of approx. 5" in diameter to left thigh with slight warmth to area. Y Y 03/15/2001 03/16/2001 1 NONE PUB UNK NONE OH0014 1
0169259 04/30/2001 HI 15.0 73 F 04/23/2001 Induration, only mildly tender at site of injection. Y 04/20/2001 04/21/2001 1 NONE PVT PUB NONE NONE 1
0169260 04/30/2001 CA 12.0 12 M Eruption of generalized papular varicella-like rash with itching on 4/15/01. Varicella shot given on 4/13/01 in addition to Hep-B and Hep-A and PPD. Y U 04/13/2001 04/16/2001 3 PVT UNK PPD/Pasteur Conn/C0521AA/SC?RFA NONE 1
0169261 04/30/2001 PA 5.0 5 M 04/21/2001 Right arm with area of redness to upper outer area that was warm to touch, non-tender; 3" in length and 1" wide. Y 04/18/2001 04/21/2001 3 PVT PVT NONE NONE NONE 1
0169262 04/30/2001 KS 16.0 5 M 04/17/2001 Within hours, post vax, back of neck got very swollen and could not turn head. Had a headache, fever and sensitive to light and sound, followed by years of migraine headaches. Y 08/29/1990 08/29/1990 0 PUB UNK NONE NONE NONE 1
0169263 04/30/2001 UT 35.0 35 F 04/24/2001 On 3/7/01, I began to have all over body itching. There was no extreme rashes. This continued consistently, all hours of the day. On 3/24/01, I went to a doctor who said I probably had "winter itch". He put me on Claritin and gave me some other instructions. I still have the itching. The beginning of April, the muscle in my right arm began to hurt. This is where I had the shot. The pain continued to come and go in my arm. A rash did show up for about 1 week and went away, but itching continues. Y N 02/28/2001 03/07/2001 7 PUB PVT NONE NONE NONE 1
0169264 04/30/2001 OR 0.25 1 .3 M 04/23/2001 Febrile grand mal seizure. Y Y 04/11/2001 04/21/2001 10 PVT PVT Mild URI 1
0169265 04/30/2001 NE 66.0 66 F 04/23/2001 Pt received Pnu-Imune IM in left deltoid on 4/5/01 at 09:15 and by 14:00 that day, she developed arm pain, golf ball sized swelling. The following day, she saw physician. She received Epinephrine and another (?) medication IM. Y Y 04/05/2001 04/05/2001 0 PVT PVT Glucophage NONE NIDDM; Hyperlipidemia; post inner ear infections 1
0169266 04/30/2001 MD 66.0 66 F 04/17/2001 Given pneumovax only with no problems within 30 minutes. 1 1/2 hours, later, upper left arm with increased aching, fatigue, red and splotchy rash around shot site and itching. At home she took aspirin. Next AM she was still sore and under arm pit, had dizziness and trouble with vertigo, laying down. Slightly improved that day. Y 04/12/2001 04/12/2001 0 MIL MIL Premarin, Provera, MVI, Synthroid NONE NONE 1
0169267 04/30/2001 NY 45.0 45 F 04/20/2001 Vaccine administered on 1/25/01, left deltoid. On 1/30/01, complained of muscle soreness with ROM limited secondary to pain. No erythema or edema. Treat with warm compress and NSAID. To follow-up with PMD if symptoms persist or worsen. Continues to be sore at LVA. N 01/25/2001 01/26/2001 1 OTH OTH NONE NONE NONE 1
0169268 04/30/2001 GA 4.0 4 F 04/23/2001 Local reaction area at injection site red and warm to touch. No treatment. Y 04/20/2001 04/21/2001 1 PVT PVT Otitis media 1
0169269 04/30/2001 MA 57.0 57 F 04/25/2001 Rash and pain at injection site, gradually progressing to numbness in 90% of arm. Pt currently is in chronic pain. Y N 02/17/2001 02/18/2001 1 3/20/01; MRI upper extremity-presumed dx of myositis PVT PVT Paxil Laceration of hand NONE 1
0169270 04/30/2001 WI 12.0 12 F 04/24/2001 Fever, chills/sweats, joint pain and temperature to 103F X 4 days. Joint effusions in knees, elbow and ankles. Y U 04/19/2001 04/20/2001 1 WBC-14.6K; 81 seg; 101 lymph; 9 mono PUB PUB NONE NONE NONE 1
0169271 04/30/2001 NC 1.0 1 .0 M 03/17/2001 Severe rash Y Y 03/05/2001 03/17/2001 12 NONE PVT PUB 3/5/01-ampicillin; 3/15/01-Augmentin; 3/16/01-auralgan Left AOM NONE NC01045 1
0169272 04/30/2001 HI 30.0 31 M 04/20/2001 Post vax, pt immediately had dizziness with shortness of breath, light-headedness, fatigue, numbness to bilateral legs and feet and tightness in chest. Pt felt like he was going to pass out. IV drip started, oxygen given and called 911. Sent to ER. Had the same reaction after Hep-A was given. Y N 03/14/2001 03/14/2001 0 NONE PVT PVT NONE NONE Slight nausea~Hep A (no brand name)~1~30.00~In Patient HI0104 1
0169273 04/30/2001 MD 1.2 1 .1 U 04/23/2001 Pt developed varicella. He had received varicella vaccine 7/7/98. Y U 07/07/1998 04/23/2001 1021 UNK UNK 1
0169274 04/30/2001 AL 1.0 1 .0 M 04/24/2001 Seven days, post vax, my son developed a fever of 100.2F, diarrhea and vomiting that has lasted for seven days now. U 04/10/2001 04/24/2001 14 UNK UNK 1
0169275 04/30/2001 MD 2.0 1 .0 M Shingles, 1 year after varivax vaccination. U 04/21/2000 04/07/2001 351 Physical exam UNK UNK NONE 1
0169276 04/30/2001 OH 17.0 M Abdominal cramps and pain, nasal congestion and reddened mucosa, sore throat, slightly hoarse voice, malaise, myalgias and headache, all within 24 hours of receiving vaccines. 04/06/2001 04/06/2001 0 UNK UNK 1
0169277 04/30/2001 IA 1.9 M 04/04/2001 One day post vax, the pt had a quarter sized area of induration and redness. Pt seen in clinic 3 days post vax, induration and redness measured 5 X 8 mm. 04/03/2001 04/04/2001 1 UNK UNK 1
0169278 04/30/2001 SC 1.25 1 .2 M 04/23/2001 Pt developed a silver dollar sized area of induration and slight erythema. No warmth. Surrounding swelling left anterior mid and lateral thigh, no lymphendenopathy. Pt went from observation to being treated with heat and Motrin. Observe for daily improvement. U 04/17/2001 04/18/2001 1 NONE PVT PVT NONE 1
0169280 05/01/2001 MD 0.25 0 .3 F 01/26/2001 Following vaccination, it was reported that the pt developed a febrile seizure. The pt was hospitalized on 1/31/99 for three days. The pt was switched to DT for further immunizations with no seizures Follow-up information is requested. Y 3 U 01/28/1999 UNK UNK U2001002330 1
0169281 05/01/2001 FL 1.8 1 .0 M This patient was extremely irritable the night of his shots and never seemed the same afterwards. He became withdrawn, lost eye contact, regressed in many ways including language and gross motor movement. He did not laugh as much and generally was sick. He would cry and have when he screamed for an hour straight. He lost his spirit. Diagnosed with encephalopathy. Y N 05/09/2000 05/09/2000 0 They had all the genetic tests done - negative. Lab test indicate some levels of concern. PVT OTH NONE NONE NONE 1
0169283 05/01/2001 OK 4.0 4 M 04/17/2001 After receiving the vaccines, the mother started home with the child and noticed that he was wheezing and starting to swell up. The pt was taken to the ER. Diagnosed with allergic reaction Y Y Y 04/17/2001 04/17/2001 0 PUB PUB NONE Heart Murmur OK0118 1
0169284 05/01/2001 IN 0.7 0 .6 M 05/22/2001 A physician reported via a company representative that a child(age and gender unspecified) received a second dose of prevnar on an unspecified date. Approximately 6 weeks post vax, the pt was hospitalized for bacteremia, The infecting organism was unspecified. Follow up info received on 05/18/2001 from the reporting physician revealed that the 8 month old male had a history of hypoplastic left heart syndrome with Norwood and Glenn shunt procedures. He received the 2nd dose of Prevnar on 03/05/2001. On 04/15/2001, the child presented with a history of high fever and shocky appearance. A blood culture revealed the presence of type 3 pneumococci and a diagnosis of ambulatory bacteremia with bacterial sepsis was made. The child was treated with intravenous ceftriaxone and he was since recovered. FOLLOW-UP INFORMATION received on 10/12/01 from the reporting physician revealed the child had a history of cardiac murmur and a sustained oxygen saturation in the 70 % range. Upon the child's hosptial admission, respiratory syncytical virus was also detacted The remainder of the physical examination was normal except for clubbing and cyanosis of the child's extremties. The child received treatment with three courses of antibiotics. NOTE: Upon receipt of this information, this report has once again been classified as a 15-day expedited report Y Y 03/05/2001 04/15/2001 41 Blood culture - positive(type 3 pneumococci present); culture NOS positive-respiratory syncytial virus positive PVT OTH UNK UNK hypoplastic left heart syndrome HQ0009423APR2001 1
0169285 05/01/2001 FL 3.0 M 04/18/2001 My son was given an inoculation called Prevnar. Two weeks later, he began experiencing symptoms of pneumonia and was later dx'd as such by his physician on 4/16/01. He has had a fever of 103F-104F for the past 6 days. As a result, I have been out of work for the same amount of time and am considering legal advice on this matter as I am sure that the shot was the cause of his suffering. U 03/30/2001 04/13/2001 14 UNK UNK NONE NONE 1
0169286 05/01/2001 AR 2.5 2 .6 M 04/30/2001 Local swelling and redness. Y 04/25/2001 04/27/2001 2 NONE PVT PUB Recurrent OM 1
0169287 05/01/2001 SC 0.5 0 .5 M 04/19/2001 Client started spiking elevated temperature of 103F and would not keep medication down; vomited on every attempt to keep Tylenol down, approx. 10-15 times. Leg started swelling and redness occurred on 4/13/01, approx. 2 1/2"; then mother took infant to ER, after calling PMD. Client's mother states that the ER physician dx'd cellulitis and administered medications for signs and symptoms; Tylenol and an antibiotic in ER. Y Y 04/12/2001 04/13/2001 1 PUB PUB Teething but no temperature SC0124 1
0169288 05/01/2001 FL 0.2 0 .2 F 04/24/2001 Dx: High fever of 101.6F, lethargic, irritable. On 4/10/01, follow-up pt still irritable and fever of 101.8F at office. Gave Ceftin antibiotics. On 4/12/01, follow-up, is still lethargic and fever is 101.8F. Sent to hospital for full work-up. Probable viral meningitis or adverse reaction to vaccine. Y U 04/05/2001 04/05/2001 0 CBC and UA (cath)-results WNL. PVT OTH NONE 1
0169289 05/01/2001 IN 0.9 0 .9 F 04/25/2001 2cm abscess on right hip at injection site. Abscess drained and cultured on 4/21/01. Treated with Keflex X 10 days. Pt has had 2 previous abscess events, always at immunization injection site. Y 03/26/2001 04/21/2001 26 Preliminary culture; gram stain; no WBC, no organisms seen. Rare coagulate-negative Staphylococcus. PVT PVT NONE NONE GER with failure to thrive Unspecified reaction~Hib + Hep B (Comvax)~2~0.75~In Patient 1
0169290 05/01/2001 CA 3.0 3 F 04/18/2001 Pt complained of abdominal discomfort on 4/17/01 at approx. 15:00. This morning at approx 04:30, child began vomiting and continued to vomit and feel nauseous this morning at 10:00. U 04/17/2001 04/18/2001 1 NONE PUB PUB NONE NONE NONE CA010030 1
0169291 05/01/2001 MO 1.0 1 .0 F 04/19/2001 Vomiting, temperature to 103F, fussy and nasal congestion. Y 04/09/2001 04/09/2001 0 PVT PVT URI 1
0169292 05/01/2001 OK 0.2 0 .2 F Started crying right after vaccine and is still crying about 5 hours later. Stops briefly, only when wears herself out. No fever or vomiting. Resolved without incident. Y 04/09/2001 04/09/2001 0 NONE PVT PUB NONE NONE Questionable gross motor delay OK0117 1
0169293 05/01/2001 AK 2.0 2 .8 F 04/20/2001 6 X 5 red, raised, erythematous reaction surrounding vaccine site. Y 04/18/2001 04/19/2001 1 MIL MIL NONE NONE 1
0169294 05/01/2001 OR 1.0 1 .0 M 04/25/2001 Rash; covered with varicella, noted 9 days, post vax. Y Y 04/13/2001 04/22/2001 9 PVT PVT Tylenol 1
0169295 05/01/2001 AL 1.0 1 .0 F 04/23/2001 Rash in her face, legs, hands and stomach. Fever and swelling of joints. Treated with Motrin. Y Y 03/19/2001 04/01/2001 13 PVT OTH 1
0169296 05/01/2001 MI 1.08 1 .1 F 04/19/2001 Tremors, agitation, anorexia and fever. Y 03/13/2001 03/15/2001 2 NONE PVT UNK NONE NONE Eczematous dermatitis; allergic rhinitis 1
0169297 05/01/2001 MN 0.3 0 .4 F Fine pinpoint rash appeared from head to foot in 3 days, post vax. She has been fussy since vaccination. Rash is all disappeared within 5 days. Sister had 1 day of fever during the same period. Y 04/09/2001 04/12/2001 3 PVT PVT NONE NONE NONE 1
0169298 05/01/2001 NY 4.0 4 F 04/25/2001 6 hours, post vax, had hives on face. Seen in ER and treated. Call in the morning at home. No problems. Y Y 04/24/2001 04/24/2001 0 OTH UNK Zetal, Singulair HIV (+) HIV (+); Asthma 1
0169299 05/01/2001 NY 4.0 4 F 04/25/2001 One hour, post vax, pt had hives all over back to trunk. Given epinephrine and Benadryl and it decreased. Called 911 and was seen in ER at 18:00. Call in the morning. Hives all resolved. Y Y 04/24/2001 04/24/2001 0 OTH UNK Zerit, Epivir, Singulair HIV (+) HIV (+); Asthma 1
0169300 05/01/2001 CO 4.0 4 F 04/23/2001 Fever to 103F, lasting 4 days. Leg pain and swelling. Unable to bear weight for 2 days; 3 more days of limp. Y 03/27/2001 03/28/2001 1 PVT PUB CellCept, Gantrisin, etc NONE S/P heart transplant; Asthma 1
0169301 05/01/2001 ID 0.2 0 .2 F 2 1/2 hours, post vax, pt began crying inconsolably. Mom noted swelling at right thigh administration site. She brought baby in. Swelling continued to increase. Cold compresses applied to area; 3" diameter, warm, tender and central bruising between site of 2 injections. No temperature. Y Y 04/11/2001 04/11/2001 0 PVT PUB NONE NONE 1
0169302 05/01/2001 WA 0.4 0 .4 F 04/19/2001 Severe irritability with fever X 48 hours. RSV + 2 days, post vaccines by NP wash. Y Y 04/17/2001 04/17/2001 0 RSV + 2 days, post vaccines by NP wash. PVT PUB NONE RSV Prematurity 1
0169303 05/01/2001 SC 24.0 24 M 03/15/2001 Vaccine administered while pt was deployed to Saudi Arabia. Pt was itching at the site of injection. Y 02/15/2001 02/16/2001 1 MIL MIL Centrum vitamins NONE NONE 1
0169304 05/01/2001 TX 32.0 32 M 04/13/2001 Local reaction about 18cm erythema, warm macules. Y Y 04/11/2001 04/12/2001 1 MIL MIL HCTZ NONE HTN Cellulitis~Anthrax (Biothrax)~6~30.00~In Patient 1
0169305 05/01/2001 OH 0.3 0 .3 M 04/18/2001 Inconsolable crying > 5 hours. Encouraged parents to seek medical attention from pediatrician. Y 04/17/2001 04/17/2001 0 NONE PUB PUB Pediacare Little cough H/O RSV in 1/9/01. OH0018 1
0169306 05/01/2001 OH 4.0 0 .4 F 04/19/2001 Became red, blotchy areas on neck, face, trunk and limbs, 10 minutes, post vax. No respiratory distress. Observed for 30 minutes. Rash lightened and disappeared. Y 04/19/2001 04/19/2001 0 PUB PUB NONE NONE NONE OH0017 1
0169307 05/01/2001 PA 51.0 51 M On 4/6/01, received vaccine and 10 minutes later, developed fullness in ears, felt crackling in back of head. (Wife has had 2 week episode of upper respiratory infection). Pt presented on 4/9/01 for evaluation and treatment. He was given Z-pack of Zithromax for sinusitis and otitis media. Required a refill on 4/19/01. Recovered on 4/24/01. Y Y 04/06/2001 04/06/2001 0 Opaque Tympanic membranes with erythema with pus left nostril. PVT PVT NONE NONE 1
0169308 05/01/2001 WA 36.0 26 M 04/24/2001 Fever to 100F, onset 4/16/01. (Not listed on visit). Also, arm is swollen around shot area. Y U 04/16/2001 04/17/2001 1 NONE PUB PVT NONE NONE NONE 1
0169309 05/01/2001 GA 4.0 4 F 04/20/2001 Left thigh swollen from groin area down to knee, significant larger that the right thigh, red but not hard. Y U 04/17/2001 04/17/2001 0 PVT PVT Vantin Right ear draining 1
0169310 05/01/2001 MN 1.0 1 .0 M 04/27/2001 On 4/22/01, temperature was 103.2F; on 4/23/01, temperature was 105.6F; on 4/24/01, temperature was 105.2F. He had over 40 chickenpox. Recovering but still a few chickenpox. Y N 04/12/2001 04/22/2001 10 CXR, Blood and Urine for meningitis or pneumonia, bladder infection or other bacterial infection but all were negative. PVT UNK NONE NONE 1
0169311 05/01/2001 OR 50.0 50 F 04/17/2001 On 4/13/01 it was reported that the left arm was red, hot, swollen and had hives. The symptoms started on 4/12/01 and started "getting worse". The pt was referred to PMD or ER for consult/evaluation. On 4/17/01 follow-up call provided that the pt was given anti-histamine and cortisone and had improved. MD states may be immune problem. Will not receive third dose. Y Y 04/11/2001 04/12/2001 1 PUB PUB HRT NONE possible allergy to latex OR200119 1
0169312 05/01/2001 CA 21.0 21 F 04/20/2001 The pt states about 1-2 hours post vax she developed itching rash on face which spread rapidly, has hx of asthma and took Ventolin inhaler when dyspnea developed. By the time she reached the doctors office, the rash was "all over". The Ventolin did resolve breathing problem. Y Y 04/17/2001 04/17/2001 0 PUB PUB Ventolin NONE asthma CA010031 1
0169313 05/01/2001 CA 0.6 0 .6 M 04/28/2001 The pt experienced redness, swelling and indurated area to the right thigh that covered a 3cm x 5cm area. Advised to apply cold compresses every 2 hours for 10 minutes. Call back if no improvement. Y 04/17/2001 04/17/2001 0 PUB PUB CA010032 1
0169314 05/01/2001 CA 2.0 2 1 M 04/18/2001 The pt experienced a red, swollen warm indurated area around the vaccination site to the right deltoid. Y 04/16/2001 04/17/2001 1 PUB PUB CA010033 1
0169315 05/01/2001 CA 4.0 4 M 04/22/2001 Left arm (deltoid) with 5cm X 5cm area of redness and swelling. Dx'd with cellulitis. U 04/20/2001 04/22/2001 2 PVT UNK NONE NONE 1
0169316 05/01/2001 MI 2.0 2 .8 M Leg swelled and became itchy. Y 04/23/2001 04/24/2001 1 PVT UNK NONE 1
0169317 05/01/2001 OR 9.0 9 F 04/24/2001 Gave varivax on 3/19/01 and pt broke out in a vesicular rash on 3/25/01. Examined on 3/26/01 and had 30-40 vesicles on red base on arm, face and trunk. Went onto develop more than 400+ lesions by 4/3/01. Y 03/19/2001 03/25/2001 6 NONE PVT PVT NONE NONE 1
0169318 05/01/2001 SC 28.0 28 F 04/20/2001 On 4/18/01 at 08:00, arm at injection site sore. On 4/19/01, late PM, area slightly swollen and small bumps around injection site with itching. On 4/20/01 at 16:15, no change. Referred to PMD for possible medicines for symptom relief. U 04/17/2001 04/18/2001 1 PUB PUB Ortho Novum 777 NONE Abnormal pap on 12/00-Colposcopy 2/01 SC0125 1
0169319 05/01/2001 SC 1.2 1 .2 M 04/12/2001 15-20 minutes, post vax, pt broke out in a rash around mouth with progression to arms. When he awoke the next morning, rash was on legs. Rash was red, fine with itching, not hive-like. Treated by mom with Benadryl. Mom states he is unable to drink juice of any kind, has scalding in diaper area. He has a history of a seizure on 1/01 but not taking any medications. Denies change in diet, soap or detergent. Rash was gone by 4/14/01 but started having respiratory problems on Saturday and went to PMD who told mom breathing problem not related to immunizations. Y Y 04/11/2001 04/11/2001 0 PUB PUB NONE NONE Febrile seizure on 1/01 SC0123 1
0169320 05/01/2001 SC 10.0 10 F 04/09/2001 Child's mom noted child had flushed face on 4/7/01 and child complained of stomach rash (not visible to mom). Mom gave child Benadryl and symptoms have since, faded. Fraternal female twin complained of more severe symptoms: redness, large bumps on abdomen and back with itching. Mom denies that children have had new clothes, food, or soap in the last few weeks. Mom stated that she did just start back to using Downy fabric softener on 4/1/01, after not using it for several months. She stated that she had used different scents in the past, was using the green label now (? mt. spring scent). Y 04/03/2001 04/07/2001 4 NONE PUB PUB NONE NONE NONE SC0122 1
0169321 05/01/2001 MI 12.0 1 .0 F 04/13/2001 Fever 7 days, post vax; rash on hand, trunk and face, 10 days, post vax. Y 03/30/2001 04/07/2001 8 NONE PVT PVT NONE NONE NONE 1
0169322 05/01/2001 TX 14.0 14 F 04/23/2001 Pt complaining of onset of flu-like symptoms, headache, decreased appetite and fatigue within 4 hours, post vax. Keeping her out of school for 2 days. Appt. with MD on 4/20/01. Y 04/19/2001 04/19/2001 0 NONE PUB PUB NONE NONE 1
0169323 05/01/2001 FL 22.0 22 F 04/25/2001 Went to medical center on 12/15/00, after receiving MMR on 12/14/00. Urgent care record: 22 year old student who got unknown vaccine today and now complaining of progressive, diffuse urticaria, post vax, plus itching. No respiratory involvement. Physical exam NAD; mild diffuse urticaria on arms and trunk. No neuro deficit; afebrile. No local redness at injection site. Y 12/14/2000 12/15/2000 1 PUB PUB Synthroid 1
0169324 05/01/2001 NM 15.0 14 M 04/24/2001 Light-headed, vomiting, headaches and pain in both hips. Y 04/04/2001 04/04/2001 0 NONE PUB PUB NONE NONE NONE 1
0169325 05/01/2001 OH 42.0 42 F 04/16/2001 Rubella vaccine given on 3/29/01. Pt went to ER on 4/14/01 with a complaint of rash and itching. Y Y 03/29/2001 04/13/2001 15 OTH OTH Antibiotic eye ointment Diabetes 1
0169326 05/01/2001 CA 4.0 4 M 04/01/2001 Swelling at injection site within 12 hours. Painful to walk the same day. Y Y 04/11/2001 04/12/2001 1 NONE PVT OTH NONE NONE NONE 1
0169327 05/01/2001 MO 12.0 12 M 04/26/2001 Varicella given 3/26/01. On 4/3/01, child had severe case of chickenpox (face, abdomen, trunk, legs, arms, back and hair). Took to MD on 4/3/01. Zyrtec and Aveeno baths and Aveeno lotion prescribed. Child missed 8 days of school. Is ok now. Old pox marks, evident. Y Y 03/26/2001 04/03/2001 8 PUB PUB NONE NONE Asthma 1
0169328 05/01/2001 FL 8.0 5 F 04/26/2001 Red, pimple-like dots, about 10 dots, total. Examined on 4/13/01. Confirmed chickenpox. Y Y 02/17/1998 04/13/2001 1151 PVT PVT TB/246611/0 previously NONE Seasonal allergies 1
0169329 05/01/2001 FL 4.0 1 .0 M 04/26/2001 Red, pimple-like dots all over body; "at least 150 on back alone". Mom says sent to urgent care. Y Y 02/17/1998 04/23/2001 1161 NONE PVT PVT NONE Seasonal allergic rhinitis 1
0169330 05/01/2001 IL 4.0 1 .1 F 04/25/2001 Failure of varicella vaccine Y 05/07/1998 04/24/2001 1083 NONE PVT PVT NONE 1
0169331 05/01/2001 NC 60.0 60 M 04/27/2001 Pt states had dizziness, 2 hours, post vax. He had difficulty focusing on day 2. Went to ER and was referred to a neurologist, who dx'd him with diplopia. Immune mediated event due to immunizations. Y Y 04/11/2001 04/11/2001 0 MRI-WNL PUB PVT NONE NONE Sick~Typhoid Vi Polysaccharide (no brand name)~1~0.00~In Patient 1
0169332 05/01/2001 IL 43.0 43 F 03/22/2001 Within 5 minutes of injection the pt complained of strong dizziness and nausea and then within the hour a headache began. Symptoms have lasted 2 days thus far. Y 03/20/2001 03/20/2001 0 UNK UNK 1
0169333 05/01/2001 CT 57.0 57 F 04/26/2001 The morning of 4/25/01 the pt noticed redness and swelling of right upper arm at the injection site. Area approximately 6 x 4 inches, slightly warm to the touch and tender. Y U 04/24/2001 04/25/2001 1 PVT PVT Lotensin, Pravachol, Toprol laceration right thumb increased blood pressure, increased cholesterol, allergy to PCN, Cipro, adhesive tape 1
0169334 05/01/2001 KY 5.0 5 M 04/24/2001 The pt experienced edema with a hard lump in the right upper extremity deltoid. The pt had a fever of 104 which came down with Tylenol. No neurological symptoms. U 04/09/2001 04/10/2001 1 PUB PUB NONE 1
0169335 05/01/2001 NH 5.0 5 F 04/24/2001 The mom called stating arm was sore for 1st day or two post vax. Now has red ring around injection site with golf ball size lump. Child is acting normal. Y 04/17/2001 04/17/2001 0 NONE PVT PUB fluoride NONE NONE 1
0169336 05/01/2001 CO 1.51 1 .5 M 04/10/2001 The pt experienced right thigh swelling presented by parent on 4/18/01. Swelling increased as the day progressed. No abscess, no mass. Treatment was heat and ibuprophen. Y Y 04/17/2001 04/18/2001 1 NONE PVT PVT NONE NONE 1
0169337 05/01/2001 CA 1.6 1 .6 M 04/20/2001 Pt developed a 5 inch erythemic, hot rash from the point of DTAP injection site. N 04/18/2001 04/20/2001 2 PVT PVT 1
0169338 05/01/2001 WA 29.0 29 F 04/25/2001 The pt experienced a maculo-papular rash and then vaccine related measles developed 9 days post vax. Y Y 04/12/2001 04/21/2001 9 PVT PVT NONE NONE 1
0169339 05/01/2001 OH 0.3 0 .3 M 04/23/2001 Approximately 3-4 hours post vax the pt developed pallor and excessive crying for 1-2 hours. Y 02/28/2001 02/28/2001 0 PVT PVT NONE ??????? 1
0169340 05/01/2001 MA 6.0 5 F 04/24/2001 Pt developed itchy rash 04/17/2001; seen on 04/20/2001 with 8-10 vesicles ?? side chest and groin ??? Y 04/05/2000 04/17/2001 377 NONE PVT PUB NONE 1
0169341 05/01/2001 IL 0.7 0 .7 F 04/24/2001 Pt developed a sterile abscess at injection site. Treated with Ilosone for 5 days Y 04/19/2001 04/19/2001 0 PVT PVT Intol; albuterol prn recurrent mild wheeze 1
0169342 05/01/2001 IN 9.0 9 M Approximately 15 minutes post vax, the pt was brought back into clinic with difficulty breathing, running nose and flushing. Found to have wheezes throughout lung fields. Given albuterol nebulizer treatment twice, chlorpheniramine and transported to ER via ambulance. Pt was given steroids and observed. Y Y 04/12/2001 04/12/2001 0 PUB PUB NONE pertussis allergy and orange dye 1
0169343 05/01/2001 CA 42.0 42 F 04/26/2001 11 days post vax, the pt had a severe HA with rash over trunk, on arms and legs. Y Y 04/04/2001 04/15/2001 11 PUB UNK NONE PCN; ampicillin EES; codeine 1
0169344 05/01/2001 OK 8.0 8 M 04/11/2001 Client in to health dept with rash on body, swollen hands, temperature 102 - 105 F. Rash started one day post vax, turning into whelps two days post vax accompanied by swelling of hands and feet, hands turned purple and began to peel on 02/16/2001 and fingernails on right hand middle finger and index finger came off. 02/20/2001 right side of face and right eye swollen, pt seen in ER where blood was drawn and was WNL, pt treated with a steroid injection and sent home with prednisone, Benadryl and hydrocortisone. No school until 02/26/2001, heart echo done on 02/26/2001 was WNL. Y Y 02/07/2001 02/07/2001 0 02/20/2001 blood test WNL; 02/26/2001 heart echo WNL PUB PUB OK0116 1
0169345 05/01/2001 NY 32.0 32 F 04/20/2001 03/26/2001 - enlarged lymph nodes in groin; 04/03/2001 - enlarged lymph node in right arm; 04/05/2001 - continued above symptoms and stiff joints in knees, ankles, hips and painful left and right hands/wrists; 04/10/2001 - seen by PMD for labs/evaluation; 04/14/2001 - ER visit due to pain in hands; treated with Neurontin; 04/15/2001 same as above and treated with Percocet and Nortriptyline Y N 03/20/2001 03/26/2001 6 Evaluated by neurologist - EMG and nerve conduction studies were done; diagnosis brachial plexopathy; ordered physical therapy 3 times weekly; estimated absence 1-2 months; PVT PVT Vioxx NONE - Rubella negative titer PCN; morphine; muscle/joint pain 1
0169346 05/01/2001 TX 35.0 35 F 01/30/2001 The pt developed lightheadedness and wheezing, 5 and 10 minutes respectively, post vax. The pt has a medical history of asthma. Follow-up information was received and the pt was treated with asthma medications shortly after wheezing occurred. The pt recovered. Y 11/30/2000 11/30/2000 0 PVT OTH Atrovent; Serevent Asthma NOS HQ5479803JAN2001 1
0169347 05/01/2001 TX 49.0 49 F 04/18/2001 Subsequent to receiving vax, the pt developed elevated blood pressure, 210/107 mmHg. The pt states that her blood pressure prior to receiving vax was 150/156 mmHg. On 01/03/2001 she went to see her HCP and her blood pressure was 166/110 mmHg in HCP office. The pt was treated with Micardis mg QD. Medical history includes hypertension. Y U 12/01/2000 12/14/2000 13 Blood pressure increased 210/107 (mmHg) Blood pressure increased 186/110 (mmHg) PVT OTH Sular UNK Hypertension NOS HQ5536704JAN2001 1
0169348 05/01/2001 NV 43.0 43 F 01/25/2001 Immediately post vax, the pt developed an injection site reaction characterized by a red, itchy, welt, described as a target. Blood pressure was increased to 132/100. The pt was treated with diphenhydramine and recovered. Y 01/02/2001 01/02/2001 0 UNK PUB PUB NONE NONE adult respiratory distress syndrome; cholelithiasis; pancreatitis NOS; Uterine hemorrhage HQ5708509JAN2001 1
0169349 05/01/2001 OR 79.0 79 U 01/25/2001 Immediately post vax, the pt developed an injection site reaction characterized by swelling and bruising. U 01/15/2001 01/15/2001 0 UNK OTH OTH NONE NONE UNK HQ6012617JAN2001 1
0169350 05/01/2001 CA F 03/28/2001 Following vax, the pt developed swelling of lip and inside the mouth and a rash that is on-going since administration. No further information was available at the date of this report. U 12/01/2000 12/01/2000 0 UNK PVT OTH UNK UNK UNK HQ6463126JAN2001 1
0169351 05/01/2001 TN 58.0 58 F 04/03/2001 Subsequent to receiving vax, the pt developed an injection site reaction characterized by focal fatty atrophy in the subcutaneous tissue and numbness. U 11/27/2000 UNK PVT OTH UNK NONE UNK HQ6994508FEB2001 1
0169352 05/01/2001 NY 40.0 40 M 04/06/2001 Subsequent to receiving vax, the pt developed an injection site reaction characterized as hard, red and itchy. The pt has had the flu shot many times and has never had a reaction before. The events resolved in one week. Y 11/28/2000 11/28/2000 0 UNK OTH OTH UNK UNK UNK HQ7338416FEB2001 1
0169353 05/01/2001 PA 46.0 46 M 04/24/2001 Subsequent to receiving vax, the pt developed swelling at the injection site. The pt reported that in 01/2001 a lump appeared at the injection site and was tender and sore. In 03/2001 a biopsy of the injection site tissue revealed fat necrosis with calcifications. U 12/19/2000 Biopsy NOS - injection site: fat necrosis with calcifications PVT PVT vitamin D NONE UNK HQ8496616MAR2001 1
0169354 05/01/2001 NY 59.0 59 F 04/18/2001 Within 1 hour post vax, the pt experienced periodic neuropathy in her feet and hands. She stated that this felt like pins and needles that moved around a bit, then resolved. The reporter also noted that she developed peripheral neuropathy in summer of 2000 while taking Baycol. Baycol was stopped and the symptoms resolved. It was also noted that the pt had taken Mevacor for 10 years and stopped, then restarted in 09/2000 as an alternative to Baycol and experienced a strange dry feeling in her throat. She stopped taking Mevacor and symptoms were resolving as of 01/04/2001. U 12/01/2000 12/01/2000 0 UNK PVT OTH Premarin UNK Dry throat; hypercholesterolemia; hysterectomy NOS; Peripheral neuropathy NEC HQ5599005JAN2001 1
0169355 05/01/2001 IL 3.0 3 M 03/21/2001 9 days post vax, the pt developed hives, which extended from the trunk to legs. He was treated with Benadryl which initially resolved the hives; however, they returned by morning. U 12/23/2000 01/01/2001 9 UNK PVT PVT NONE NONE UNK HQ5710909JAN2001 1
0169356 05/01/2001 IL 60.0 60 F 01/25/2001 One day post vax, the pt experienced pain at the injection site. As of 01/12/2001 the pt continued to experience this pain. U 12/07/2000 12/08/2000 1 UNK PVT PVT NONE NONE UNK HQ5965016JAN2001 1
0169357 05/01/2001 AR U 04/06/2001 One day post vax, four pts developed an injection site reaction characterized by pain and swelling. Additional reports will be generated when identifying information is provided. U 01/23/2001 01/24/2001 1 UNK PVT OTH UNK UNK UNK HQ6464326JAN2001 1
0169358 05/01/2001 SC 34.0 34 F 04/03/2001 Subsequent to receiving vax, the pt developed acute pain at the injection site. The pt was treated with unspecified steroid injections and physical therapy. The reporter indicated that the physician stated that the pain was because the injection was administered too high in the deltoid. U 12/29/2000 UNK OTH OTH NONE NONE UNK HQ7066409FEB2001 1
0169359 05/01/2001 CA F 02/15/2001 Subsequent to receiving vax, the pt developed a large local reaction and a diffuse uritcarial eruption all over her body. A diagnosis of allergic was made. She underwent skin testing to the same lot number of the vax, which confirmed an allergic reaction to this product. She has received influenza virus vaccine in the past without incident. Y 12/01/2000 skin test: confirmed the diagnosis of allergic reaction. OTH OTH UNK UNK UNK HQ7203214FEB2001 1
0169360 05/02/2001 KY 5.0 5 M Seizures and developmentally delayed with 1st set of vaccines. Had a high temperature and death with 2nd set. Y 09/12/2000 N 09/08/2000 09/08/2000 0 PVT PVT Condition caused by prior vaccine (seizures and developmentally delayed). Seizures~Measles + Mumps + Rubella (MMR II)~1~0.00~In Patient 1
0169361 05/02/2001 AL 4.0 U 01/16/2001 A healthcare professional reported that a 4 year old child received an injection of the Flu Shield 2000-2001 formula on 12/8/00. The following day, the child died. No further information was available at the date of this report. Y 12/09/2000 N 12/08/2000 12/09/2000 1 UNK PVT OTH UNK UNK UNK HQ5878312JAN2001 1
0169362 05/03/2001 TX 40.0 39 F 04/26/2001 It was reported that a female patient received Imovax Rabies series, vaccination dates were 09/20/00, 09/23/00, 09/27/00, 10/04/00, 10/19/00, and 12/18/00. Reportedly after the 1st dose the patient developed a little red indented area on face. After sixth dose the patient developed two spots, one by left eyebrow appeared to be a "boil". The patient seen by physician treated with antibiotics, 12/18/00 still unresolved. The patient was hospitalized two times (02/17/01 through 02/22/01, and 03/28/01 through 04/07/01). From follow up correspondence received on 12/11/2001, it was reported that the patient received the rabies immunization series for post-exposure prophylaxis from september through december 2000.She subsequently developed an autoimmune penniculitis and arthralgias which may have been triggered by the immunization although not a direct cause of it. Y Y N 09/20/2000 UNK UNK U2001006620 1
0169364 05/03/2001 IL 2.0 0 .2 F 04/26/2001 The same evening the infants temp elevated to 103. She was seen in the ER and admitted to the hospital. She slept for 6 hours. Vomited and developed hives. Hospitalized 6 days, sent home on Ceclor and a nebulizer. Diagnosed with bronchitis and respiratory distress. Y Y 6 Y 04/20/2001 04/20/2001 0 PUB PUB NONE NONE 1
0169365 05/03/2001 NY 2.0 2 .2 F 04/25/2001 24 hours, post vax, pt suffered maculopapular rash on chest, back and buttocks. No oral lesions. No fever. Y Y 04/23/2001 04/24/2001 1 PUB PUB NONE NONE 1
0169366 05/03/2001 MI 2.0 2 .0 M 04/23/2001 Pt received his 1st dose of Prevnar on 4/9/01. He began having copious watery diarrhea without vomiting or fever, within 24 hours. He had started to recover when seen on 4/16/01 but had a 3 1/2 pound weight loss. Y 04/09/2001 04/09/2001 0 NONE PVT UNK albuterol nebulizer as needed NONE Asthma 1
0169367 05/03/2001 CA 1.0 1 .0 F 04/25/2001 Diffuse papular rash, noted onset about 48 hours, post vax. No respiratory distress. Y U 04/23/2001 04/25/2001 2 OTH PUB Tuberculin/Connaught/C0619AA/ID/LFA/0 previously ~Pneumo (Prevnar)~1~2.00~In Sibling 1
0169368 05/03/2001 CA 3.0 3 F 04/20/2001 Child was vaccinated on 4/17/01 at approx. 16:00. Mother states at approx. 20:00, the child complained of itching and a rash was noted on chest and back. Child was taken to PMD on 4/18/01. Per doctor's notes: fine papular rash on chest and back (light pink color). Treated with Rx Atarax. Mother states rash barely visible by day #3. Y Y 04/17/2001 04/17/2001 0 NONE PUB PUB NONE NONE NONE 1
0169369 05/03/2001 IN 1.25 1 .3 F 04/26/2001 Parents would like me to report the fact that after child has received each Prevnar, within about 20 days, pt developed an otitis and the parents have attributed the otitis on the Prevnar. Of note; the child has had multiple otitis media episodes-4/3/00; 10/31/00; 11/24/00-12/4/00-12/15/00; 1/25/01-2/5/01-2/9/01-2/15/01 (tubes) 3/21/01; 4/26/01. The dates signify visit and recurrence. Y Y 04/09/2001 04/26/2001 17 PVT PVT NONE NONE Recurrent otitis media with bilateral myringotomy tubes 1
0169370 05/03/2001 IN 1.2 1 .2 M 04/27/2001 On 4/22/01, mother noted 2 red bumps (3 days after) vaccines. Over the next 3 days, increased in number of red hive-like spots. With father over weekend and not sure of diet or skin exposures. Had chocolate candy during this period also. Seen at clinic on 4/25/01. Alert, playful. TM with injected areas, mouth clear with no lesions. Scattered hive-like (urticaria) rash with erythema multiforme-like areas confluent on left leg scattered over trunk, face and other leg and arms. Treated with Benadryl. Y Y 04/19/2001 04/22/2001 3 PUB PUB NONE Sensitive skin; eczema 1
0169371 05/03/2001 OH 1.25 F 05/01/2001 4cm X 5cm erythematous, warm, indurated area on right lateral thigh, scattered red papules over legs, abdomen and arms. Y PVT OTH 1
0169372 05/03/2001 IL 24.0 24 F 01/05/2001 States that after leaving MD, injection site started itching. Approx. 20:00, she noticed 6 or 8 welt-like areas (red and raised) and itching around upper deltoid area where injection had been given. States she is allergic to adhesive and she did not tell nurse when she put a bandaid on. Client left the bandaid on until 20:00. Client has not been changed to a new seizure medicine. (She doesn't know the name). Client to call MD to notify him of what occurred. Denies itching today. States muscle is "a little sore". Y 01/01/2001 01/04/2001 3 PUB PUB Serzone, Claritin, Ambien, Proventil, Asthmacort Seizure disorder; depression 1
0169374 05/03/2001 NY 4.0 4 F 04/10/2001 The pt's mother states that the pt ha a rash on the right shoulder. The rash was described as redness with some white bumps extending distally, occurred immediately aft receiving the DTAP vax. Y Y 04/10/2001 04/10/2001 0 PUB PUB NONE NONE NONE 1
0169375 05/04/2001 AR 0.2 0 .2 F 04/23/2001 The infant's brain swelled. She died the next day. All the doctors did was run tests. They didn't do anything to try and save her. Autopsy report received states child died from bilateral subdural hematoma - homicide. Y 02/24/2001 Y Y Y N 02/22/2001 02/23/2001 1 Blood, x-ray, EEG, CT Scan. PUB OTH Carbinoxam Sepsis, Pneumothorax, congested. Head trauma at birth. breathing different~Hep B (no brand name)~1~0.00~In Patient 1
0169376 05/04/2001 8.0 M 04/30/2001 This report describes the occurrence of a probable toxic epidermal necrolysis / Stevens Johnson Syndrome in a 8.7 year old boy receiving Hepatitis B vaccine. On an unknown date, a dose of Hepatitis B vaccine was given. On the same day, after vaccination, the face of the child became red and "blotchy." He was given Acetaminophen (Paracetamol) and went to bed with a "runny nose." The next day, his face looked as if it had been sunburned and the rash spread to his abdomen and groin. The child was hospitalized with epidermal detachment, mucous membrane involvement and joint stiffness. The case was diagnosed by a dermatologist. The vaccination course has been discontinued. This case was classified by the authors as a probable Stevens-Johnson syndrome / toxic epidermal necrolysis. The authors made the following comments: "For the one definite and five probable cases, 2 features support a causal relationship between vaccination and SJS/TEN. First the patients did not have evidence of an acute illness and were not taking other medications at the time of the vaccination, reducing the chance the rash was caused by another etiology. Second the timing of the onset of symptoms and the diagnosis of SJS/TEN after vaccination is consistent with the published literature on SJS and TEN after medication and infection." Nevertheless, they mentioned that a causal link between SJS/TEN and vaccination could not be established by this study for different reasons. Y U UNK UNK NONE NONE 20010100151 1
0169377 05/04/2001 0.5 F 04/30/2001 On an unknown date, 1 day post vax, the child developed conjunctivitis with discharge, cracked lips, a swollen face, friable skin on face and diaper area that was detached when couched. The child was hospitalized. Eyelid culture was positive for branhamella catarrhalis, staphylococcus aureus and streptococcus pneumoniae after onset of rash. Acetaminophen was given after the onset of the rash. This case was classified by the authors as a probable Stevens-Johnson syndrome toxic epidermal necrolysis. A follow up report received 9/5/2002 adds: The authors made the following comments: "For the one definite and five probable case, 2 features support a causal relationship between vaccination and SJS/TEN. First the pts did not have evidence of an acute illness and were not taking other medications at the time of vaccination, reducing the chance the rash was caused by another etiology. Second the timing of the onset of symptoms and the diagnosis of SJS/TEN after vaccination is consistent with the published literature on SJS and TEN after medication and infection." Nevertheless, they mentioned that a causal link between SJS/TEN and vaccination could not be established by this study for different reasons (see article for more info). Y U Eyelid Culture - Result text: positive for branhamella cattarrhalis, staphylococcus aureus, streptocuccus pneumoniae after onset of rash. UNK UNK 2001010001 1
0169383 05/04/2001 IN 14.0 14 M 05/02/2001 Admitted to the hospital on 4/23/01. Fever 102F-103F; erythema of chest; cellulitis. Spoke to mother on 5/2/01 and she reports that pt still has lesions. His mother reports that lesions were infected. Annual follow up on 11/21/2003: "Vaccine recipient recovered from the adverse events that were reported for this vaccination. Doctor reported child is fine; no residual symptoms on 07/10/2002." Y Y 2 U 04/11/2001 04/15/2001 4 PVT UNK Arnold-Chiari malformation and cerebral palsy with resultant partial paraplegia IN20018 1
0169384 05/04/2001 WI 45.0 M 04/20/2001 After 1st injection this patient's finger joints swelled and hurt, stiffness in his shoulders. It got worse after 2nd injection; and gradually got better aver 6 months. The patient refused his last injection. Per annual follow-up, doc 215044; symptoms still persist but seem to be slowly improving with time. Follow up: Patient continues to have pain and swelling in hands especially after heavy use of his hands. Slight sleepiness at middle fingers joints. STiffness in knuckels essentially stated. Never stated any redness in any joint. No treatment, no diagnosis, no medical records available. Y N 03/19/1999 03/26/1999 7 PVT UNK NONE 1
0169386 05/04/2001 NY 1.0 F 04/27/2001 Information has been received from a physician concerning a 12 month old pt who was vaccinated with MMRII and varicella virus vaccine live and subsequently, the pt experienced a "very high fever" and was hospitalized. It was noted that the reporter was wondering what to do about the 2nd dose of MMRII. Follow-up information has been received from a physician stating that the child was in for her 1 year old well visit on 1/9/01. The child was well at the time of the visit and received the vaccinations. On 1/10/01, the mother described the child as "shaking of hands, feet, and lip for 45 minutes, with some difficulty breathing and gasping for air". The physician stated that the child may have had a febrile seizure, however, it was not witnessed by anyone but the pt's mother. The child was taken to the ER where her temperature was 103F. She was treated with acetaminophen (Tylenol). The child had a 'barking cough' and a CXR was done and reported as normal. A CBC and blood culture were also done and came back normal. The child had recovered and was discharged from the ER to home with discharge dx of "fever, secondary to immunization". The child has no history of seizure or febrile seizure, but does have a history frequent otitis media infections. It was noted that the pt has had another episode of fever of 104F with cold symptoms. Upon internal review, the shaking of hands, feet and lips for 45 minutes, difficulty breathing and gasping for air, and fever secondary to immunization were considered to be "Other Important Medical Events". Y Y Y 01/09/2001 01/10/2001 1 Chest x-ray 01/10/01 Normal. Blood culture 01/10/01 Normal. Complete Blood Cell 01/10/01 Normal. Temp measurement 01/10/01 103 degree. Temp measurement 02/01 104 degree. OTH OTH Frequent otitis media WAES01041160 1
0169387 05/04/2001 WI 0.2 0 .2 M This infant received his 1st dose of Prevnar on 01/18/01. He contracted pneumococcal meningitis (serotype 9V) on 03/11/01. He had a seizure on 03/15/01. The infant had RSV bronchiolitis and was admitted for this on 02/26/01. Y Y 9 Y 01/18/2001 03/15/2001 56 Blood Culture (+) and Spinal Fluid (+) PVT PVT NONE NONE NONE 1
0169389 05/04/2001 NY 50.0 49 F 04/30/2001 This patient had 3 vaccines - one each month 03/99, 04/99, 05/99. The patient had Lyme disease twice, once in 1995 and once in 1997. the patient has had travelling arthritis and allergies since the 3 vaccines.Doc 196038 states that patient has pain in joints, although less due to course on antibiotics but pain is still there. Vaccine should not be given to people who have had lyme disease in the past. Per doc 215766, Travelling Arthritis still present. Right hand still swollen in + around thumb up to above wrist. Difficulty + pain in using right hand. Allergies still present. A severe case of Lyme Disease which was produced by the vaccine is still present. Sweating, hair loss, neck pain and exhaustion still present. After spending most of the last year in bed, the recovery process is moving along very slowly. Y N 02/19/1999 02/19/1999 0 PVT UNK NONE NONE NONE 1
0169394 05/04/2001 VA F On the day of injection the patient was red and swollen at the injection sight. On the seventh day the patient had high pitched screaming for 2 days, high fever, immune damage, whopping cough, 4 months speech delay. Y Y N whooping cough, speech delay PVT PVT NONE NONE ~Vaccine not specified (no brand name)~~0.00~In Sibling 1
0169395 05/04/2001 TN 0.75 0 .8 M 04/25/2001 The pt experienced intussusception one day after the Prevnar vaccine was administered. Reduction was performed and was successful. Follow up: 04/18: crying, stomach ache, unconsolable after eating, vomiting, no eating, pale. Low grade fever, 100.2 F, few hours in hospital, stayed in hospital for 2 days. Y Y 2 Y 04/17/2001 04/18/2001 1 Unknown exactly - reduction was successful. PVT PUB antibiotic for ear infection otitis media (bilateral) Otitis Media 1
0169396 05/04/2001 VA 0.08 0 .1 M 04/20/2001 It is reported by the pt's mother stating that she noticed mild neurological change during the course of his immunization schedule from 1992 to 1997. After each course of vaccines he reacted with swollen shot sight fever screaming and 10 to 15 days later high fever hives malice. In 1994, he was placed in special pre-ed at 3-, 1/2 yrs for speech and motor skill delays. She noticed a decline in health speech motor skills after every immunization visit. It wasn't until his big 5 year old prekindergarten mega dose DPT, Pollomeyelitis, and MMR that she connected his decline with vaccinations. After the last round of vaccines he was never the same. The day of the vaccination on 05/28/1997 within six hours red hot swollen shot site: Given both in left and right arm, glassed look, fever, arms to sore to lift six days of fever, malice, glass look lethargic. The mother reported these symptoms to his pediatrician and talked about her concerns but he was vaccinated anyway. She states that,"he vomited every time I washed his hair, he heard noises that pained him severely, he had to be wrapped in sleeping bags to control him at school, he suffered from severe abdominal pain, his hands could not hold onto a swing, he banged himself into the wall, he conforted himself by total absorption in lining up his plastic animals, he slept restlessly, he was insistent on routine and structure, his health declined:strep infection fever severe diarrhea and constipation, he varied from extreme hyper activity to extreme muscle fatigue, no social skills, delayed toilet training not able to sit down to have bowel movement, biting growling violent angry." Y Y 10 Y Y N 08/25/1992 08/25/1992 0 Not immune to Mumps, Measles or Rubella although vaccinated. PVT PVT NONE NONE 1
0169397 05/04/2001 VA 1.5 1 .5 M 04/15/2001 Loss of speech, loss of social interaction, loss of eye contact, severe eating problems, irritability, sound and light sensitive, sleep disorder; all of which appeared within one week of administered vaccine. The 60 day follow-up states lack of speech, lack of social skills, chronic diarrhea and inability to digest. Y N 01/28/2000 02/01/2000 4 Pertussis titers-0; Mercury being excreted in urine PVT PVT Fever, fussy, sneezing, coughing, congestion, wheezing, NONE Severe vomiting and diarrhea~DTP (no brand name)~3~0.00~In Patient 1
0169398 05/04/2001 OH 0.5 0 .5 F 04/18/2001 The pt experienced crying, crankiness, fever, treated with Tylenol the same day of vax. The pt had a strep infection with ER treatment in fall of 1987. Bronchitis in the fall/winter of 1987, limping in the summer of 1988 and in the Fall of 1997, JRA was diagnosed. Per doc 214443, annual follow-up: JRA juvenile rhumetoid Arthritis. Do not feel it was one specific vaccination that caused the response, but caused from the combination of vaccines over a period of time. Y N 07/27/1987 07/27/1987 0 PVT PVT ~DTP (no brand name)~~0.30~In Sibling 1
0169399 05/04/2001 OH 0.4 0 .4 M 04/18/2001 Red, crying, temperature, irritable. Given Tylenol, same day, sick with ear infections for weeks after. Given antibiotics. Was drooling 6-8 weeks later, lost eye contact 4 months later and weakness 4 months later. Auto-immune disorder; encephalopathy, apraxia hypotonic. The 60 day follow-up report states neurological immune disorder gastrointestinal. This child was developing normally and was insulted by vaccines over a period of time not a single vaccine caused this much regression on his systems. Missing vaccine information not available. Dx autoimmune encephalopathy, high functioning autistic. Tx aricet solu- Medrol and IVIG. Poor social skills. Limited eye contact. low mptor strength. Encorpresis. Also notes generalized weakness and droopy eyes before 8 months of age. Onset unrecalled. Y Y 06/11/1990 06/11/1990 0 PVT PVT NONE NONE ~DTP (no brand name)~~0.50~In Sibling 1
0169400 05/04/2001 TX 1.6 1 .5 F 04/25/2001 Crying for 2 hours and 45 minutes; 2 to 3 days later, had her 1st seizure. Stopped sleeping all night. Made choking sounds when she slept. When I finally saw a seizure (grand mal) from start to finish. Took her to doctor and 1 week later was put on meds. Y Y N 04/01/1998 04/03/1998 2 EEG X 3-abnormal (grand mal seizures); MRI-nml; MRI w/dye-nml PUB OTH NONE NONE NONE Unspecified reaction~Vaccine not specified (no brand name)~~1.00~In Patient 1
0169401 05/04/2001 NY 57.0 55 F 04/25/2001 Within 24 hours of the 2nd vaccination, I suffered severe flu-like symptoms; joint aches and headache for about 2 weeks. Then I had severe joint problems and muscle aches which became worse as time went by. This developed into arthritis in all my joints and neck and shoulders. I can't lift or walk without severe pain. I can't sleep more than 1 hour at a time without waking up in pain. Y Y 05/17/1999 05/18/1999 1 PVT OTH NONE NONE NONE 1
0169402 05/04/2001 ID 0.5 0 .5 M 04/24/2001 The pt experienced alternating lethargy and irritability, spiked fever to 102.2 and leg twitching. 2-3 episodes of emesis with diarrhea. No seizure. Pt spiked temp a total of 3-4 times in 24 hours. Y N 04/23/2001 04/23/2001 0 NONE PVT PUB NONE mild URI 1
0169403 05/04/2001 WA 2.0 2 .1 M 04/24/2001 Erythema multiforme on bilateral anterior thighs. U 04/16/2001 04/18/2001 2 PVT PUB Tylenol NONE Allergic to Amoxicillin (rash) 1
0169404 05/04/2001 WI 0.3 0 .4 M 04/25/2001 Induration that caused the flesh to be firm from the skin surface to the bone (femur) and erythematous in an area 1.5cm X 2cm (at Prevnar injection site). Y Y 03/28/2001 03/28/2001 0 NONE PVT PVT Bactrim NONE Right hydronephrosis and left multi-cystic kidney (dysplastic and non-functional) 1
0169405 05/04/2001 IL 1.0 1 .0 F 04/26/2001 High fever, 104F-105F, post vax, on 4/23/01. To ER on 4/23/01 that evening with continued seizures, vomiting, lethargy. No overnight stay. On 4/24/01, child is better. On 4/25/01, mom reports child had afebrile seizure with no lethargy following. Child has PMD follow-up and will have EEG. Y Y 04/23/2001 04/23/2001 0 PUB PUB 1
0169406 05/04/2001 MO 0.5 0 .5 F 04/25/2001 Seizure with fever of 39.7C; self resolved. Seen at ER. Y Y 04/23/2001 04/23/2001 0 CBC; Urine culture; Blood culture; Stool culture PVT PUB Loose stools NONE 1
0169407 05/04/2001 KS 0.5 0 .5 M 04/18/2001 This child seemed to develope a tic (ear jerk to shoulder) 4 hours, post vax. It persisted for 1 week and gradually faded away over that week to 10 days. At 16 hours, post vax, he also had 3 brief episodes of about 10 seconds each, wherein he tensed and shook. But seemed conscious. My inference is that the child momentarily had tics; possible seizure. Y 03/16/2001 03/16/2001 0 CBC; Chem Panel; CT-all neg about 20 hours, post vax. EEG-pending. Neuro consult was normal on 4/18/01. UNK UNK NONE Unremarkable pregnancy; elective Cesarean section for breech presentation 1
0169408 05/04/2001 ID 1.3 1 .4 M 04/24/2001 Fever to 104F (ear) 3 hours, post vax, associated with chills. Spiked fever X 3 with 3 episodes of emesis. Alternating irritability and lethargy. Treated with antipyretics and close observation. Y N 04/23/2001 04/23/2001 0 NONE PVT PUB NONE NONE 1
0169409 05/04/2001 KS 1.0 1 .0 F Fever of 102F, nausea, shaking (could be from fever). Fever duration, 48 hours. Treated with Tylenol and lots of fluids. On 4/20/01, developed lesions around the varivax injection site. Y 04/11/2001 04/18/2001 7 NONE PUB PUB NONE NONE 1
0169410 05/04/2001 FL 1.25 1 .2 M 05/02/2001 Pt's mom called and said he has woke up with spots on arms, legs and some on trunk and face. Instructed mom on chickenpox treatment. Y 04/20/2001 05/02/2001 12 NONE PVT PVT NONE NONE NONE 1
0169411 05/04/2001 FL 5.0 4 F 05/02/2001 Pt has small bump on leg that is red and warm to touch. Told mother to ice the area and massage periodically. Y 04/30/2001 05/02/2001 2 NONE PVT PVT NONE NONE NONE 1
0169412 05/04/2001 NJ 5.0 5 F 01/19/2001 On 1/6/01, pt complained of soreness, pruritus and erythema the size of 50 cents at 10:00 AM, Saturday, left deltoid area. On 1/8/01, Monday, mother noted bruise on left deltoid 1"-2" in diameter and still complaining of pruritus. Pt complained of discomfort for 1 1/2 weeks. No treatment or medicines given. On 1/18/01, area of left deltoid, remains slightly bruised and discolored. Y 01/04/2001 01/05/2001 1 NONE PUB PUB Zyrtec NONE Recurrent sinus and ear infection NJ200110 1
0169413 05/04/2001 IN 1.6 1 .7 M 03/26/2001 Mother reported child had swollen eyes, vomiting, hives and a reddish complexion on face. Went to ER and was given Benadryl and something else. Doctors attributed this to Prevnar. Child all ok on morning of 1/4/01. Child received 4 vaccines on 3/7/01 (no Prevnar) and all is ok. Went to ER around 18:30 PM on evening of 1/3/01. Y 01/03/2001 01/03/2001 0 NONE PUB PUB NONE NONE NONE IN20017 1
0169414 05/04/2001 IN 1.4 1 .4 F 05/02/2001 Hives on both legs and back, 48 hours, post vax. (On Benadryl through 24 hours after shot). Temperature was 102F, 48 hours, post vax. Inconsolable crying up to 48 hours, post vax. Sleepiness for 2 nights. Wouldn't eat or drink for 3 days but now drinking. 5 days, post vax, and still has hives and low-grade temperature of 99F. Y N 04/27/2001 04/29/2001 2 OTH UNK NONE NONE Unspecified reaction~Pneumo (Prevnar)~1~1.25~In Patient 1
0169415 05/04/2001 TX 1.0 M 04/18/2001 Pt had a high fever for 1 week, post vax, and then ended up having a febrile seizure. Y Y PVT UNK Ear infection 1
0169416 05/04/2001 OH 1.3 1 .4 M 04/25/2001 Vomited immediately, within 10-15 minutes and had generalized hives, pallor and tachycardia. Given 12.5mg Benadryl po and 0.1cc Epi 1:1000 SC with good response. Sent to ER for observation by EMS. Y Y 04/19/2001 04/19/2001 0 OTH PUB albuterol nebs Asthma 1
0169417 05/04/2001 TX 1.7 1 .6 M 04/20/2001 Pt had a fever of 104F, 6 hours, post vax. Y Y 04/17/2001 04/17/2001 0 PVT PVT NONE NONE NONE 1
0169418 05/04/2001 NY 0.5 0 .5 M 04/25/2001 Febrile seizures, 24 hours, post vax. Y Y 04/20/2001 04/21/2001 1 PVT UNK 1
0169419 05/04/2001 NY 1.08 1 .0 M 04/27/2001 Mom states that on 4/13/01, pt was very cranky and wanted to be held most of the day. Had a fever; mom did not take temperature with a thermometer but states he felt very warm. She gave him Tylenol every 4-6 hours. On 4/14/01, he woke up with a pink rash on face, arms, chest, back and legs. No fever on 4/14/01, he "even" was acting better. Rash lasted 4-5 days. Did not take child to MD because father-in-law visited and said he had the measles. He knew the rash because he had measles as an adult. Y 04/03/2001 04/13/2001 10 PUB PUB NONE NONE 1
0169420 05/04/2001 AL 2.0 2 .3 F 04/13/2001 Broke out all over in a papular red rash, the next day. Seen today, 10 days later, and rash is still present over entire body. N 04/03/2001 04/04/2001 1 NONE PUB PUB NONE NONE AL0105 1
0169421 05/04/2001 SC 1.7 1 .6 F 05/07/2001 Fever up to 104F, asthma attacks, back to back, requiring treatment every 4 hours. Knot in left leg with soreness and redness and swelling. Applied warm soaks to leg. Tylenol was given for fever and albuterol nebs for asthma. Y 04/24/2001 04/24/2001 0 NONE PUB PUB Albuterol prn for asthma NONE History of asthma 1
0169422 05/04/2001 OH 47.0 47 F 04/30/2001 Pt had local reaction and went to ER, 24 hours later. Y 04/27/2001 04/27/2001 0 Eosinophil count elevated; LFT's-nml MIL MIL NONE NONE 1
0169423 05/04/2001 WA 41.0 41 M Arthritis in hands (1/99); may be linked to Anthrax vaccine. N 01/09/1999 01/09/1999 0 MIL MIL NONE NONE NONE 1
0169424 05/04/2001 MN 32.0 32 M Approx. 12 hours, post vax, pt experienced numbness and muscle spasms down length of right arm, across chest and right shoulder blade. Y U 04/10/2001 04/10/2001 0 NONE OTH OTH NONE NONE NONE 1
0169425 05/04/2001 PA 41.0 41 F 04/26/2001 Generalized hives within several hours, post vax. Treated with topical steroid ointment. Y 01/08/2001 01/08/2001 0 Blood test for varicella titer OTH PUB Prozac, Micro D NONE Allergy to Ceclor 1
0169426 05/04/2001 CA 3.0 3 F 04/16/2001 Fever, vomiting and rash developed the next day, post vax. Y U 03/27/2001 03/28/2001 1 Throat culture for strep-negative PVT PVT NONE NONE 1
0169427 05/04/2001 NY 61.0 61 F 05/01/2001 No data provided. Y Y 04/11/2001 04/11/2001 0 PVT PVT tamoxifen NONE Breast cancer 1993 1
0169428 05/04/2001 IA 1.2 1 .2 F 04/13/2001 45 minutes, post vax, started having fever of 103F. On 4/10/01 at 14:00, mom noted episode where child had been lethargic, jerked, screamed and sat up then flopped back. ER visit at 09:30. She was restless that night but better/normal Wednesday. Y Y 04/09/2001 04/09/2001 0 PUB PUB NONE IA01006 1
0169429 05/04/2001 IL 2.0 1 .0 M 05/01/2001 Approx. 12 small blister-type lesions, possibly modified chickenpox. Y Y 08/16/1999 04/21/2001 614 NONE PVT PUB NONE NONE NONE 1
0169430 05/04/2001 NH 1.0 12 F 05/01/2001 On 4/27/01, injection site was red, swollen and painful. Increased swelling and redness on 4/28/01 and went to ER. Dx'd with aseptic abscess. Rx'd with ibuprofen and cold packs. Seen at MD on 4/30/01 and was beginning to resolve. Rx continues. 1/2" needle used for administration of vaccine. Is recovering. Y U 04/27/2001 04/27/2001 0 PVT PUB NH0112 1
0169431 05/04/2001 ME 1.0 1 .0 F 04/30/2001 Mild case of chickenpox. U 04/18/2001 04/28/2001 10 Clinical assessment only PVT PUB NONE NONE Mongolian spot on buttock (blue spot) birth mark ME01012 1
0169432 05/04/2001 IN 0.2 0 .2 F 05/01/2001 Crying non-stop for 36 hours. No physical findings and no fever noted. Y 04/09/2001 04/09/2001 0 PVT PUB NONE NONE NONE IN20019 1
0169433 05/04/2001 FL 1.08 1 .0 M 04/26/2001 Varicella rash on torso, back and foot. U 04/02/2001 04/25/2001 23 PVT PVT 1
0169434 05/04/2001 FL 1.0 1 .0 M 06/25/2000 Fever of 103F (oral) with irritability. Gave Tylenol. Y 05/16/2000 05/19/2000 3 PVT PVT NONE NONE NONE 1
0169435 05/04/2001 MD 0.5 0 .5 M 04/26/2001 Restless and crying on the night of the shots. Fever was up to 102F with diarrhea. Next morning, still had fever of 102F and diarrhea. Returned to office on 4/26/01 with temperature up to 103F. DTAP reaction versus viral illness, per doctor's notes. Y Y 04/25/2001 04/25/2001 0 PVT PVT Resolved asthmatic bronchitis 1
0169436 05/04/2001 MA 32.0 32 F 04/27/2001 Onset of symptoms on 3/26/01 with sore throat and rash. On 3/29/01 had joint swelling, arthralgia but no fever. Y Y 03/14/2001 03/26/2001 12 CBC; Throat culture; LFT's; Mono spot: RRP-all nml PUB UNK NONE 1
0169437 05/04/2001 CA 39.0 38 M 04/27/2001 Day after shot received, pt complained of fever, chills, backache and sore arm. U 04/25/2001 04/26/2001 1 PVT PVT NONE NONE NONE 1
0169438 05/04/2001 KY 11.0 11 F 04/30/2001 About 4 minutes, post vax, she had severe itching. Gave Benadryl 50mg po (liquid). Pt became dizzy about 5 minutes later. Laid flat and monitored vital signs and called 911 to site. Pt did return to normal in approx. 15 minutes. Y 04/26/2001 04/26/2001 0 PUB PUB Allergy shots, Zyrtec NONE Allergies to mold, dust, penicillin and weeds. KY2001029 1
0169439 05/04/2001 KY 40.0 40 F 04/27/2001 Moderate pain in left arm from shoulder to finger tips. Lymph nodes, under left arm and across collar bone, across left ribs and down to left elbow extremely swollen and painful. Was seen by MD on 4/26/01 and dx'd with lymphedema and an infection of cellulite tissue from bacteria in multi-dose vial. Seen by private physician. Y U 04/23/2001 04/25/2001 2 PUB PUB NONE NONE Sulfa KY2001028 1
0169440 05/04/2001 GA 49.0 49 M 05/02/2001 Pt called the office on 4/30/01, to report developing an itchy rash, the evening of 4/26/01. Also stated, on 4/30/01, that the rash had occurred after the 1st dose of vaccine but not reported. Y 04/26/2001 04/26/2001 0 PVT PVT Stated taking Levaquin 1
0169441 05/04/2001 NY 3.0 3 F 05/02/2001 On 5/2/01, left arm at site of injection had 4cm area of erythema and induration. No pain. Y 04/20/2001 05/01/2001 11 PVT PUB NONE NONE 1
0169442 05/04/2001 AZ 4.0 4 M 04/25/2001 Arm, which received DTAP and IPV, noted swollen but not tender and FROM. Y U 04/23/2001 04/24/2001 1 PVT PVT NONE NONE NONE 1
0169443 05/04/2001 MO 20.0 21 F 04/23/2001 Post vax, pt said she didn't feel well. Color pale and arms rigid. Immediately, pt was transferred from chair to floor in lying position by 2 nurses. Eyes receded and arms stiff for about 5 seconds. Color returned and arms relaxed. Pt responsive. BP 130/62 and pulse 80 and regular. At 11:00 AM, she sat in upright position and complained of a headache. She denied any further medical treatment but asked that we call her husband for transport home. Left at 12:00, noon. Site of MMR was reddened. All other sites showed no signs of any reaction. Y Y 04/23/2001 04/23/2001 0 PUB PUB PPD/Aventis/C057AA/ID/LA/0 previously; birth control pills NONE Seasonal allergies MO2001022 1
0169444 05/04/2001 IN 0.75 0 .8 F 04/19/2001 NONE Y 04/16/2001 PVT PUB 1
0169445 05/04/2001 MN 11.0 11 F 04/18/2001 On 19:30, sudden onset of dizziness, felt like she was going to pass out, hands shaking, hands ice cold, broke out in perspiration, felt weird and skin was clammy. Had a headache before going to bed and took Advil. The next morning, had a headache and hands still cold, clammy and feeling not right. Did not go to school. Slept all day and felt better in the afternoon after sleeping. Y 04/17/2001 04/17/2001 0 NONE PUB OTH NONE NONE NONE 1
0169446 05/04/2001 MN 12.0 13 F 04/25/2001 03/27/01, came home from school complaining of extreme tiredness (unusual for her) and a slight headache and a sore arm. At 17:30 gave Tylenol for headache and sore throat. The next morning complained of being hot during the night. Temperature in AM was 98.6F (usually 97F), complained of back hurting and sore muscles. Too tired to go to school. Took to clinic for strep test and it was negative. Felt better in the afternoon but still tired and wiped out to go to school. The next morning was fine. Y Y 03/27/2001 03/27/2001 0 Strep test on 3/28/01-neg PUB OTH NONE NONE Allergy to milk and susceptible to strep. ~Hep B (no brand name)~3~23.00~In Sibling 1
0169447 05/04/2001 GA 4.0 4 F 05/02/2001 7cm X 7cm indurated and erythematous area and firm. Y U 05/01/2001 05/02/2001 1 PVT PVT 1
0169448 05/04/2001 IN 5.0 15 F 04/05/2001 About 10 minutes, post vax, pt had large red hives on both sides of face, back of both legs, behind right arm and on elbow of left arm. She had a reddish area on both knees also present. No respiratory or febrile present. HD nurse called pt's MD and he recommended Benadryl and to have parents call him in case of any respiratory problems. Also, told to go to ER, if necessary. Called mother on 4/5/01 and by the evening of 4/3/01, child all ok. Child has been ok ever since. Y 04/03/2001 04/03/2001 0 NONE PUB PUB NONE NONE NONE IN20016 1
0169449 05/04/2001 GA 0.2 0 .2 M 04/24/2001 Inconsolable crying for 2-3 hours. Y 04/16/2001 04/16/2001 0 PVT PVT NONE NONE NONE 1
0169450 05/04/2001 KS 1.0 1 .0 F 04/24/2001 Hives X 3 days on right shoulder #10-12. Treatment with Claritin. Y U 04/20/2001 04/21/2001 1 PVT PVT NONE NONE Left hydrouteronephrosis, dilated renal pelvis, megaureter 1
0169451 05/04/2001 PA 22.0 22 F 04/25/2001 Cellulitis of left arm, red, swollen, painful and hot. Y U 04/23/2001 04/24/2001 1 PVT UNK Prevention for needle stick NONE 1
0169452 05/04/2001 VA 4.0 4 F 04/25/2001 Ten days, post vax, pt had swelling develope at site of injection in right arm. Swelling gradually resolved. There was no report of another source of swelling as an insect sting/bite. Erythema also cleared. There was no pain, lymphangitis or fever. Site was almost completely cleared today, 4/26/01. Y 04/03/2001 04/14/2001 11 NONE PUB PUB NONE NONE NONE 1
0169453 05/04/2001 FL 1.3 1 .3 M 04/19/2001 Severe rash and measles-like spots from head to toe. Y 03/08/2001 03/17/2001 9 PVT UNK Took Amoxicillin at the same time as vaccinated Slight cold/ear infection NONE 1
0169454 05/04/2001 IL 0.2 0 .2 M 05/24/2000 Hypotonic, unresponsive episode, immediately, post vax, lasting an estimated 40 minutes. Possible tonic/clonic seizures, 1 day after vaccines, estimated duration of about 7 minutes. Both were witnessed only by family. Y 05/10/2000 05/11/2000 1 OTH PUB NONE NONE Prenatal ultrasound detected irregular heart beat but resolved. 1
0169455 05/04/2001 OH 11.0 11 M 04/25/2001 On 4/18/01, given MMR injection #2 as mandated. On 4/24/01, started left parotid swelling with temperature of 99F. Y Y 04/18/2001 04/24/2001 6 PVT PVT URI NONE 1
0169456 05/04/2001 KS 30.0 29 M 04/23/2001 Pt stated arm was sore, warm to touch and slightly swollen. Y 04/20/2001 04/20/2001 0 MIL MIL NONE NONE 1
0169457 05/04/2001 CA 14.0 14 F 14 year old female presents to out clinic for well child check on 4/16/01. Pt received 4 vaccines. Pt returned to clinic on 4/18/01 with pain and swelling of left deltoid and was dx'd with cellulitis and treated with Keflex. Symptoms are improving. Y Y 04/16/2001 04/18/2001 2 NONE PUB PUB PPD; Diflucan 150mg, 1 tablet given on 4/16/01. NONE NONE 1
0169458 05/04/2001 FL 1.0 1 .1 F 04/23/2001 Fever of 101F on 4/21/01. Fever of 103F on 4/22/01. Given Motrin and fever decreased. Temperature on 4/23/01 was 97.6F. No other symptoms notes. Pt is recovering. U 04/19/2001 04/21/2001 2 PVT PVT NONE NONE NONE 1
0169459 05/04/2001 NJ 1.3 1 .3 M 11/10/2000 Measles rash for 2 days and fever for 1 day. Y 10/02/2000 10/12/2000 10 PVT PVT 1
0169460 05/04/2001 TX 1.5 1 .0 F 2 days of low-grade (99F-100F) fever prior to break out of 100+ lesions covering body, trunk, arms, legs and head. Only 2-3 scabbed, started to diminish within 3-4 days, all but clear by day 8. Y 10/17/2000 03/31/2001 165 PVT PVT Zyrtec NONE NONE 1
0169461 05/04/2001 CO 1.25 1 .2 F 04/24/2001 Fever to 101.4F and tremors of arms, legs and jaw, starting on the morning after vaccines. Y U 04/24/2001 04/24/2001 0 CBC and UA-nml on 4/25/01 PVT PVT Ibuprofen Possible URI/Congestion NONE Redness, fussy, swelling and tenderness~Pneumo (Prevnar)~1~0.70~In Patient 1
0169462 05/04/2001 NJ 7.0 2 .3 M 04/26/2001 Child developed chickenpox. Child had varivax vaccine on 3/9/1996. Y 03/09/1996 04/25/2001 1873 PVT PVT Post nasal drip 1
0169463 05/04/2001 MI 0.5 1 .5 F Seizures, tremors, high fever, screaming 12 hours after vaccinations. N 04/16/2001 04/17/2001 1 PVT PVT NONE NONE NONE 1
0169464 05/04/2001 KY 1.08 1 .1 M 04/17/2001 After 15 month vaccines, my son's hair fell out. He lost about 75% of his hair. No treatment as doctors are confused as to why this happened. Hair is beginning to grow back. U 07/07/2000 08/01/2000 25 PVT PVT NONE NONE 1
0169465 05/04/2001 OH 1.5 1 .6 M 04/27/2001 10 X 15 redness and swelling over entire anterior thigh. Walks with difficulty, doesn't appear to hurt and is not scratching. Y Y 04/24/2001 04/27/2001 3 NONE PVT PVT Tylenol prn NONE NONE 1
0169466 05/04/2001 GA 1.08 1 .1 M 04/23/2001 Mom states she believes child had a seizure Saturday morning around 09:00. Found child lying in bed, staring and unresponsive, ? post-ictal, lasted about 1 hours. Did not play much the rest of the day. Slept more than normal (4-5 hours). Did not have child seen. Was referred to neurologist for evaluation. Y 04/20/2001 04/21/2001 1 PVT PVT NONE NONE 1
0169467 05/04/2001 WI 41.0 41 F 04/26/2001 Developed local reaction. Skin had a red, hot and swollen area 3.5cm X 5cm at site of injection. U 04/24/2001 04/25/2001 1 NONE OTH OTH UNK NONE NONE 1
0169468 05/04/2001 AZ 4.0 4 F 04/26/2001 Developed redness on 4/23/01, increasing to max on 4/25/01. Induration on 4/24/01. Less red and indurated today. Not tender and no fever. Seen on 4/26/01. U 04/23/2001 04/23/2001 0 NONE PVT UNK NONE No problem with MMR #1. 1
0169469 05/04/2001 MA 1.5 1 .5 M 04/26/2001 Left arm red, swollen and slightly warm at deltoid. U 04/24/2001 04/25/2001 1 NONE PVT PUB NONE NONE NONE 1
0169470 05/04/2001 CA 5.0 5 M 04/23/2001 Injection of 5th dose of DTAP in upper arm. Within hours, had pronounced redness (almost black) of upper arm and extreme swelling, ER doctor prescribed Zyrtec and sent home. Y Y 03/28/2001 03/28/2001 0 PVT UNK NONE NONE NONE 1
0169471 05/04/2001 CA 1 .3 F 04/26/2001 Left thigh edema and erythema which started about 2-3 hours, post vax. Y 04/25/2001 04/26/2001 1 PVT UNK NONE NONE 1
0169472 05/04/2001 DE 0.25 0 .2 F 04/23/2001 Fever 103F (axillary) for 36 hours, post vax. Mom reported this when administering next immunizations on 4/20/01. Y 02/19/2001 02/19/2001 0 PVT PVT NONE NONE 1
0169473 05/04/2001 NV 4.0 4 M 04/24/2001 Complained of reddened area on arm, approx. a dollar piece in size, with redness extending down arm towards elbow. Site feels hot to touch; however client denies pain at site, fever, nausea, vomiting or diarrhea. U 04/24/2001 04/24/2001 0 PUB PUB NONE NONE ~Vaccine not specified (no brand name)~~1.20~In Sibling 1
0169474 05/04/2001 PA 1.25 1 .3 F 04/17/2001 Temperature of 101F. Right leg swollen with erythema and welt. Left leg swollen with erythema, within 24 hours. Y Y 03/13/2001 03/14/2001 1 PVT OTH NONE Reflux 1
0169475 05/04/2001 FL 40.0 39 M 04/24/2001 The pt was presented with a complaint of swelling of lips, chest and throat tightness, dyspnea for 30 minutes. Treated with epinephrine, Benadryl, Solumedrol and Albuterol. Y Y 04/24/2001 04/24/2001 0 NONE MIL MIL NONE NONE hx of allergies 1
0169476 05/07/2001 WA 17.0 17 M 05/14/2001 It was reported that a 17 year old male pt received Typhim VI vaccination dose #2 on 1/4/01. Reportedly, a few days before 1/19/01, pt had complained to his mom about spasms in his right hand. On 1/19/01, after going to a high school play, the pt was driving home and had such a severe spasm in his right hand and arm, that he was unable to drive or steer the car and went off the road into a ditch. The pt sustained no injuries from the accident. Pt started taking Malaria pills on 3/5/01. Then on 3/12/01, he took 2 pills while in Haiti. While in Haiti, pt continued to have spasms on the right side of body, 1 of which was so severe, he fell to the ground, with his eyes rolled back, but was able to hear those around him and could respond verbally but was unable to move. When the spasm was over, he could move again. Pt was taken to his PMD when he returned. At that time, he was taken off his Malaria medication. Pt continues to have increasing dizziness, which is sometimes accompanied with headaches and neck stiffness. Pt described the dizziness as feeling like he is walking during an earthquake. The pt has been to a chiropractor more than once, after 1/19/01. Pt has also experienced high blood pressure, which fluctuates between high and normal. Besides the dizziness, client complained of blurred vision. He has an appt. with an eye specialist on 5/2/01. Pt has not had any cold, sinus infection, fever, nausea or vomiting. Pt has a nervous stomach and has bouts of diarrhea frequently. Pt has been checked for bowel problems with no specific bacteria or viral infections found. Pt was given Meclovir to treat dizziness and possible middle ear infection. Pt has had no spasms since returning from Haiti. The follow-up correspondence received on 05/11/2001, it was reported that the pt recovered from this experience. It was indicated that the pt has an appointment regarding his blurred vision. There was no MRI or neuro testing done for the dizziness and spasm. Y Y 01/04/2001 01/16/2001 12 Pt has appt. regarding blurred vision-no MRI or neuro testing done for dizziness, spasms. PUB PVT NONE U200100676 1
0169477 05/07/2001 PA 67.0 67 F 12/18/2001 It was reported that a female pt received a Fluzone SV '00-'01 vaccination on 11/10/00. Reportedly, about 2 weeks, post vax, the pt developed progressive weakness in legs, pain in back and difficulty walking-dragging right foot. Family physician and Orthopedist saw pt. From folow-up correspondence received on 12/11/2001 states the electormyogram report:findings- Concentric needle EMG studies of selected bilateral lower and left upper extremity as well as bulbar muscles were examined with concentric needle EMG study. there were abundant changes reflecting acute and chronic denervation as well as fasciculation potentials and/or chronic denervation in bilateral lower and left upper extremities. Thoracic paraspinal muscle EMG on the left. Abnormal study consistent with bilater L4-5 radiculopathies. There are chronic and recent changes present. Multi level degenerative disc disease, disc bulding and spondylosis contributing to multi level ventral extradural ridging from C3-4 throught C6-7 as well as foraminal stenosis. Stenotic changes in the canal are present at C5-6 and C6-7. Annular bulges without significant canal compromise. There is mild bilateral neural foraminal encroachment at L4-5. Y N 11/10/2000 11/24/2000 14 MRI and epidural injection was done;Electromyogram-abundant changes reflecting acute and chronic denervation as well as fasciculation potentials and/or chronic denervation in bilateral lower and left upper extremities. Thoracic paraspinal muscle EMG on the left; EMG studies-increased insertional activity with +1 to +3 fibrillations and sharp waves in the left tibialis anterior, right and left peroneus longus and paraspinal muscles with many polyphasic potentials present in the vastus medialis, rectus femoris and tibialis anterior muscles; MRI-multi level degenerative disc disease, disc bulding and spondylosis contributing to multi level ventral extradural ridging from C3-4 through C6-7 as well as foraminal stenosis. Stenotic changes in the canal are present at C5-6 and C6-7. magnetic resonance imaging-annular bulges as described above without significant canal compromise. There is mild bilateral neural foraminal encroachment at L4-5. OTH OTH U2001006750 1
0169479 05/07/2001 NJ 0.25 0 .3 M 03/21/2001 At 11:00, on 1/19/01, temperature of 106F. Child admitted to hospital by PMD. The child had a rash and fever. In 24 hours, temperature went down and was discharged at 15:00 on 1/20/01. At 23:00 on 1/20/01, temperature was 104F. Admitted to the hospital again with rash and temperature which fluctuated for 2 weeks. Child was discharged on 1/30/01. Y Y 14 Y 01/18/2001 01/19/2001 1 Blood work done at hospital per mother. PUB PUB NONE NONE NONE NJ200107 1
0169480 05/07/2001 CT 39.0 39 F 05/01/2001 Crepitus and effusion in right knee; crepitus in left knee and neck. Some pain in finger joints, fatigue, some pain in hips and morning stiffness. 2nd Lymerix, lot #LY120B9 was given on 2/24/99 and 3rd Lymerix, lot #LY130A9 was given on 2/16/00. Per doc 214744, pain and stiffness in knees, neck and hips. Y N 02/16/2000 05/01/2001 440 HLA-DR4-(+); ESR 17mm/hr; 2310/ml Rheumatoid Factor; ANA (-); ASO (-); Lyme screen-(+); Western Blot (-)> PVT PVT Prozac, Valtrex NONE Depression; fatty liver; genital herpes; fatigue 1
0169481 05/07/2001 MA 0.4 0 .5 M 05/02/2001 Acute allergic reaction (hives and wheezing) 2-3 hours after shots. Admitted to hospital for steroids, Benadryl and albuterol nebulizer treatments. Also, had tried dairy (yogurt) for the 1st time, 20 minutes prior to allergic reaction. Y Y 1 Y 04/25/2001 04/25/2001 0 PVT UNK NONE Question of problems with cow milk formula 1
0169482 05/07/2001 NY 57.0 57 M 04/15/2001 CIDP; Cancer; Bells Palsy; Loss of eyesight/blurred vision; Loss of strength and problem with joints locking. Doc 214323, annual follow-up, states the followings: Razor sharp pain in feet, hands, disbling weakness and sometimes paralysis, memory loss, loss of concentration and confusion. Taking this vaccine has been the most devastating event of my life, it has crippled my body, my spirit and my life. I have been treated by appr. 8 medical experts, all concluded that the vaccine caused my various symptoms and illness. My doctors are professors of the most prestigious hospitals in the USA and none have been able to give me hope to return to a normal life and joy. Per doc 214442, patient had more tests and being checked for others things. Per follow-up, patient is often incoherent and currently undergoing many procedures. Y Y Y Y Y N 06/13/2000 06/13/2000 0 PVT PVT NONE NONE 1
0169483 05/07/2001 NY 2.3 2 .4 F 04/26/2001 ITP, 1 week after Prevnar immunization. ITP, chronic resistant to medical treatment. ITP aplastic anemia; pt will receive bone marrow transplant. Y N 02/08/2001 02/15/2001 7 Idiopathic thrombocytopenia purpura, aplastic anemia PVT PVT Intal, albuterol NONE Preemie; RDS at birth on medicine and ventilator 1
0169484 05/07/2001 CA 3.0 3 F 03/29/2001 This child had redness and swelling 15 cm diameter at injection site (left thigh). The swelling was mild, thigh was warm at the injection site, circulation was good. The patient was told to continue with Tylenol, and moist cloths as directed. U 03/27/2001 03/27/2001 0 PUB PUB NONE CA010036 1
0169485 05/07/2001 CA 1.4 1 .4 F 04/06/2001 This infant had a 5" x 5 " area of redness, non-tender on his left arm. Y 04/04/2001 04/06/2001 2 PUB PUB NONE Routine physical NONE CA010034 1
0169486 05/07/2001 NC 0.3 0 .3 M 04/26/2001 This infant's right thigh, the area where vaccines were given swelled 2 - 3" (per mom). It was red, and warm to touch. The mother called after hours service to report. She called the next day at the office to report, the swelling had decreased and the patient was doing fine. Y 04/10/2001 04/10/2001 0 PVT UNK Reglan, Zantac Reflux. NC01048 1
0169487 05/07/2001 KY 1.3 1 .2 F 05/04/2001 This infant had a maculopapular rash on her trunk, face, and extremities. She was treated with Benadryl PRN itching. Y 03/21/2001 03/26/2001 5 PVT PUB NONE Heart murmur since birth. 1
0169488 05/07/2001 GA 0.2 0 .2 M 05/03/2001 This infant received his vaccine at 10:10 AM on 05/01/01 at the county health dept. Following his immunizations, he became lethargic, and very drowsy, but was arousable. The infants heart rate was 120, color pink, skin warm and dry. His breathing non labored, normal, no rashes ever noted. The infant was kept awake by stimulation and kept at site for 45 minutes and then discharged. The mother called back to the clinic site at 2:45 stating that the infant had vomited a large amount and was gagging like. The mother was informed that this could be a systemic event after this vaccine but to take the infant now to his pediatrician, which she did. The doctor evaluated the infant, and told the mother that the throat was slightly swollen and gave him Motrin, oral steroid, and Benadryl at her office site and felt that it was a reaction to the Prevnar vaccine. The mother stated an IV was started on the infant and he was transferred to the hospital via ambulance and he stayed over night there and went back home the next day. The mother called the nurse at 5 PM, on 05/02/01, stated that the infant was back to normal self and reported the above incident. The mother stated that the CDC was called and questioned regarding adverse events following the Prevnar immunization. Y 05/01/2001 05/01/2001 0 PUB PUB NONE NONE NONE GA01038 1
0169489 05/07/2001 AL 0.3 0 .3 M 05/03/2001 This infant had a hypotonic and hyporesponsive episode. N 05/02/2001 05/03/2001 1 PVT PUB Endal HD URI NONE 1
0169490 05/07/2001 CA 1.3 1 .3 M 04/27/2001 This infant vomited once at 6:30 PM, hands mottled , lips were bluish, he had chills, and a temp of 104.5. On 04/27/01, his temp was 100 - 101. Y Y 04/26/2001 04/26/2001 0 PVT PVT NONE LOM, URI Allergic to dairy products, eggs. 1
0169491 05/07/2001 NJ 1.5 1 .7 F 04/17/2001 This infant had an elevated temp 24 hours after her immunization (103.6 F) for 5 days. She vomited 1 day, diarrhea for 3 days, started on the 2nd day. She was given Tylenol and Motrin every 4 - 6 hours. Her symptoms resolved after 2 more days of clear liquid diet. Y Y 12/19/2000 12/20/2000 1 CBC UNK UNK Resolved otitis media. Asthma. NJ200109 1
0169492 05/07/2001 SC 1.2 1 .2 F 04/28/2001 24 hours after receiving Comvax and DTaP in her left thigh, Prevnar in her right thigh, and MMR in her right arm; noticed redness and swelling in her left thigh. She was brought to the Health Dept on 04/20/01. A nurse assessed and had 4 x 3 1/2 inch area of redness, slightly swollen, slightly warm to touch on left thigh. No prior treatment other than 3 doses of Tylenol. Advised to apply cold compresses, give Tylenol see PMD if desires. Called on 04/23/01, the mother stated redness and swelling all gone. They did not see the PMD. Applied compresses and gave Tylenol. Y 04/18/2001 04/19/2001 1 PUB PUB NONE NONE History of asthma. SC0127 1
0169493 05/07/2001 MA 1.0 1 .0 M 05/01/2001 3 days after this infants immunizations were given, he had difficulty walking and keeping balance. ? fever. for 2 days. Y 01/29/2001 02/01/2001 3 NONE PVT PUB Temp 101.5 (day before immunizations). NONE 1
0169494 05/07/2001 CA 3.0 3 F 04/26/2001 This child had redness, swelling (urticarial), tenderness, and itchiness on left thigh 12 cm x 15 cm. Y 04/23/2001 04/24/2001 1 NONE PVT PUB NONE NONE NONE 1
0169495 05/07/2001 MN 1.25 1 .3 M 04/23/2001 Starting late the next day, this infant had a rash allover, erythematous papules. No other symptoms, no itching, and no fever. Y Y 04/16/2001 04/17/2001 1 PVT PVT Tylenol prn NONE NONE 1
0169496 05/07/2001 OH 0.2 0 .2 F 04/19/2001 This infant had extreme irritability, elevated crying started within 4 - 6 hours of the immunization. No fever, she refused feedings, decreased PO intake, decreased wet diapers. Phone calls 3 thru the night. On 11/15, re-examined, 24 hours after her immunizations, nonspecific, nonfocal exam except for elevated cry and irritability. Multiple phone calls regarding fussiness, decreased PO, Tylenol, Mylicon PO attempted. On 11/16, re-examined again at 48 hours. Exam still nonspecific except irritability, mild early decrease in hydration. Status sent for labs, x-ray to r/o abdominal obstruction or sepsis. On 11/17, phone progress checked: slept through the night, took 1st full bottle 5 AM, ++ irritability. Y Y 11/14/2000 11/14/2000 0 CBC - H/H of 9.3/26.7, otherwise normal. U/A normal. Abdominal x-ray - nonspecific, no obstruction. Blood / Urine cultures negative. PVT PVT NONE NONE NONE 1
0169497 05/07/2001 OH 1.3 1 .3 M 04/30/2001 This child had maculopapular lesions on his trunk. Y Y 04/18/2001 04/27/2001 9 NONE PVT PVT NONE NONE NONE 1
0169498 05/07/2001 OH 3.0 3 F 05/01/2001 Mom reports swelling at the injection site (right arm) noted on 04/25/2001. There were no other vaccinations given that date, child is fully recovered. follow up complete. Y 04/23/2001 04/25/2001 2 NONE PUB UNK NONE NONE NONE 1
0169499 05/07/2001 MI 0.25 0 .3 M 04/23/2001 This infant father called on 03/17/01, to report it was approximately 30 ,minutes after receiving vaccines. The infant became pale, and passed out with his eyes open. His breathing did not change, he stared straight ahead, he leaned his head over to one side and would not look at his father. He did not cry, he then "woke up" and started looking around. It lasted about 10 minutes. Called on 03/20/2001 no other incidents. Y 03/15/2001 03/15/2001 0 NONE PUB PUB Tylenol A cold NONE 1
0169500 05/07/2001 PA 0.5 0 .5 M 04/30/2001 After 4 month immunizations (03/14/01) and 6 month immunizations (04/25/01), the infant developed 5 - 6 days of fevers from 102 to 104. The fevers started the day of the immunizations. The infant had URI symptoms on 03/14/01 and a mild ear infection on 04/30/01. Y 04/25/2001 04/25/2001 0 NONE PVT PVT NONE NONE NONE The patient had a fever for six days~Pneumo (Prevnar)~~0.30~In Patient 1
0169501 05/07/2001 MD 35.0 35 F 05/01/2001 Chest tightness, headache and a large local reaction at vaccine site. Y Y 04/11/2001 04/11/2001 0 PFT's; BP; Pulse: Lung exam; (prior EKG and CXR) MIL MIL Nasonex, Claritin, Prinivil NONE HTN, Allergic rhinitis Chest tightness and SOB~Anthrax (Biothrax)~1~35.00~In Patient 1
0169502 05/07/2001 PA 54.0 52 F 04/20/2001 1st shot, spent 1 day and 2 nights in bed with fatigue and flu-like-Lyme symptoms, over a year of bed rest and shot and had extreme fatigue followed by sudden severe chest pains, incapacitating for several hours; accompanied by severe Lyme symptoms. Bone pain, head and neck pain, chills, tingling in limbs, muscle pain, vision problems, numbness of face, pain in joints and hands, disorientation treated for 2 years. So far still being treated. 2nd shot, had adverse reaction of extreme chest pain, incapacitated. Should have called an ambulance but could not move my arms. Extreme Lyme symptoms. Y U 05/05/1999 06/17/1999 43 PVT PVT Synthroid Thyroidism 1
0169503 05/07/2001 1.0 0 1 F 04/20/2001 Dime-sized pustular lesion at site of varicella injection on left anterior thigh. Low-grade fever at home. Faint, red bumps on left foot and posterior scalp. Recheck lesion on 4/21/1 to ensure no secondary infection. Y U 04/04/2001 04/15/2001 11 NONE OTH PVT Tine/Lederle/472208/ID/LFA/0 previously NONE NONE 1
0169504 05/07/2001 MN 3.0 4 F 04/27/2001 Left arm swelling to shoulder with induration and tenderness. Will follow-up 48-72 hours. Y U 04/26/2001 04/26/2001 0 NONE PVT UNK NONE NONE 1
0169505 05/07/2001 NJ 1.3 1 .3 F 04/23/2001 Increased temperature on 4/14/01 (no thermometer). Gave 2 drops of Tylenol every 4 hours; runny nose and cough started on 4/15/01 with vomiting and loose stools and decreased appetite, irritable and difficulty sleeping. Grandma called to report to us on 4/20/01. I suggested a visit to the doctor which resulted in a dx of throat and sinus infection. Treated with antibiotics and is fine now, on 4/23/01. Y Y 04/10/2001 04/14/2001 4 PUB PUB NONE NONE NJ200108 1
0169506 05/07/2001 FL 4.0 4 M 04/27/2001 Vaccines given on 4/26/01. Had fever and blotchy red rash to body within 12-18 hours after vaccines. Y Y 04/26/2001 04/26/2001 0 PUB PUB NONE NONE 1
0169508 05/07/2001 PA 1.0 1 .0 F 04/30/2001 Maculopapular eruption on trunk and back with a fever, approx. 1 week, post vax. U 04/18/2001 04/26/2001 8 NONE PVT PVT NONE NONE NONE 1
0169509 05/07/2001 OH 4.0 4 F 05/02/2001 Generalized erythematous maculopapular rash with skin induration around and distal to injection site. Reaction occurred about 5-6 hours, post vax. Rash persisted with Benadryl 24 hours later. No other immunizations given. Y Y 05/01/2001 05/01/2001 0 NONE PVT PVT NONE NONE 1
0169510 05/07/2001 MI 7.0 4 F 04/30/2001 Pt was vaccinated on 7/16/1997. On 4/01, she was with a cousin who was symptomatic with varicella. Pt then developed about 8 discrete varicella pox lesions, about 2 weeks later. Symptoms were treated symptomatically with Aveeno baths, Calamine lotion and Atarax prn. Y Y 09/16/1997 04/12/2001 1304 NONE PUB UNK NONE 1
0169511 05/07/2001 AL 1.4 1 .0 F 04/24/2001 Full blown varicella 03/01 after having vaccination on 10/30/00. Y 10/30/2000 03/01/2001 122 PVT PVT NONE NONE NONE 1
0169512 05/07/2001 IA 5.0 5 M 04/27/2001 Left upper arm swelling, erythema and warmth. Y U 04/25/2001 04/25/2001 0 WBC-8.7 PUB PUB NONE NONE NONE 1
0169513 05/07/2001 FL 0.6 0 .4 M 04/26/2001 Mom call on 1/15/01 and complained that pt cried on 1/13/01 about 20 minutes, inconsolably and then could be consoled but fussy. Seemed to be in a 'daze' with minimal interaction with mom and siblings X 5 days. Decreased breast feedings X 5 days, low-grade fever <101F with ? starring spell-eye looked glazed per mom. Recovered from these symptoms by the 6th day. U 01/12/2001 01/13/2001 1 NONE PVT PUB NONE NONE At 6 month visit, pt clinically had left arm paralysis; had MRI that was suggestive of perinatal ischemic event and consistent with encephalomalacia. 1
0169514 05/07/2001 IL 2.0 2 .0 F 04/30/2001 Pt had onset of fever of 103F, on same day at 19:00. Pt was crying, sleepy. The next day, was lethargic, wouldn't move, wouldn't let parents hold her. Injection site on leg was red and edematous. Y Y 04/25/2001 04/25/2001 0 PVT PVT NONE NONE 1
0169515 05/07/2001 OH 11.0 11 F 04/30/2001 The pt developed redness and tenderness at injection site treated at urgent care with Keflex. Y U 04/27/2001 04/29/2001 2 NONE PVT PVT knee pain NONE 1
0169516 05/07/2001 PA 10.0 5 M 03/30/2001 The pt developed significant and cutaneous and oral lesions (100-200). Complicated with streptpogenes pharyngitis. Required IM antibiotics. ER visit for dehydration and decreased oral intake. Y Y 09/01/1996 03/28/2001 1669 positive throat culture, leukopenia, WBC - 2.9, SGOT/SGPT - mildly elevated. PVT OTH Adderall NONE NONE 1
0169517 05/07/2001 IL 2.25 2 .3 M 04/30/2001 The pt experienced macular rash on cheeks, forehead, chin and ears. Few patches on and behind left ear. Y 04/26/2001 04/26/2001 0 PVT UNK NONE NONE NONE 1
0169518 05/07/2001 TX 39.0 39 F 04/30/2001 The morning following the vax, the pt had pain in left arm muscle "shooting" to her heart and shoulder blade. 2 hours later complained of weakness and tachycardia. Went to the ER. 1st EKG was ok, but experienced some problems later and there was an irregularity. Discharged home with no further problems, aside from soreness and knot at injection site. Y Y 04/20/2001 04/21/2001 1 EKG, CXR PUB PUB NONE NONE Mitral valve Prolapse 1
0169519 05/07/2001 MD 6.0 1 .2 M 05/01/2001 The pt has varicella. Y 06/12/1996 PVT PVT NONE NONE ~Varicella (Varivax)~1~6.00~In Sibling 1
0169520 05/07/2001 TN 1.0 0 1 M 04/27/2001 The pt experienced a chicken pox like rash at the site of the varicella vaccination. Reassurance given at the office visit. Y Y 04/12/2001 04/20/2001 8 PVT PVT NONE NONE NONE 1
0169521 05/07/2001 MO 6.0 1 .2 M 04/30/2001 Pt has varicella. Y 06/12/1996 04/28/2001 1781 PVT PVT NONE NONE NONE ~Varicella (Varivax)~1~6.00~In Sibling 1
0169522 05/07/2001 CA 11.0 F 04/03/2001 Immediately following vaccines, the pt stood up and then fainted a minute later. Before fainting, the nurse observed the pt's eyes rolling up, arms twitched and a little foaming at the mouth. The child's color was good and the child was alert a few seconds afterwards and was sent to ER. BP 90/50, P22, R20. Y Y 04/03/2001 04/03/2001 0 NONE OTH OTH NONE NONE NONE 1
0169523 05/07/2001 CA 9.0 9 M 04/02/2001 The Mom states that the night the pt received his vaccines he developed a rash over his trunk, cheeks and thighs which lasted 24 hours. No other complaints or problems. Y 02/19/2001 03/29/2001 38 NONE PUB PUB PPD NONE NONE CA010037 1
0169524 05/07/2001 CA 17.0 17 M 04/04/2001 After the last of the vaccines were administered, the pt slumped over in the chair, his body became rigid and he appeared to have a seizure. After the seizure, he was unresponsive to ammonia inhalant, verbal and tactile stimulation for about 5 minutes. Paramedics called and he was taken to the ER. Y Y 04/04/2001 04/04/2001 0 UNK OTH NONE NONE NONE CA010035 1
0169525 05/07/2001 NC 58.0 58 M 04/17/2001 The pt states that on 4/14/01 he developed itching, red whelps that began on torso and spread to the head, arms legs. Referred to his PMD. He was seen and given medication. The diagnosis was hives. Probably not due to vaccine. Y 04/11/2001 04/14/2001 3 NONE PUB PUB NONE NONE NONE NC01047 1
0169526 05/07/2001 CA 17.0 17 M 04/28/2001 About 2 minutes after administration of the vaccine the pt noted to have upward rolling of eyeballs with the generalized tonic, clonic seizures lasting for less than 15 seconds with post-ictal drowsiness without urinary or fecal incontinence. Y Y 04/18/2001 04/18/2001 0 CT scan of brain, chemistry labs PVT OTH NONE NONE 1
0169527 05/08/2001 NY U 05/04/2001 Information has been received from a physician who reported that she had received a call from an OB/GYN concerning a newborn female (WAES 01042680) who was vaccinated with Hep-B vaccine recombinant (yeast). The female died of sudden infant death syndrome. The reporting physician noted that the infant's father, also a physician, had a listing of as many as 40 additional cases of sudden infant death syndrome with Hep-B vaccine recombinant (yeast). No further details were provided. Additional information has been requested. Y N OTH OTH UNK UNK WAES01050372 1
0169528 05/08/2001 NY F 05/30/2001 Information has been received from a physician who reported that she had received a call from an OB/GYN concerning a newborn female who was vaccinated with Hep-B vaccine recombinant (yeast). The female died of sudden infant death syndrome. The reporting physician noted that the infant's father, also a physician, had a listing of as many as 40 additional cases of sudden infant death syndrome with Hep-B vaccine recombinant (yeast) (WAES01050372). No further details were provided. Additional information has been requested. Additional info from the physician indicated that this was a case of a newborn who was vaccinated with hep b vaccinee shortly after birth. A few days after birth, the newborn went home from the hospital and started to have "blue episodes." The infant was admitted to the hospital to rule out "SIDS, jaundice and sepsis." In the hospital, the infant's bilirubin was 20 and the jaundice was associated with the infant being breast-fed. The infant was subsequently discharged to home from the hospital. The physician reported that the infant did not die of SIDS, and the diagnoses had nothing to do with the hep b vaccine. At a later unspecified date the infant's mother was in the physician's office for a sick visit with an older sibling of the infant patient. The physician asked the mother how the infant was doing. The mothe rtold the physician that the infant was still having "blue episodes during feeding." The physician examined the infant and could see that the infant had "vocal cord damage due to gastric reflux." The physician referred the infant to an ENT, who made the diagnosis of gastroesophageal reflux disease. The physician reported that the infant has since recovered 100% and that the blue episodes, and the diagnosis of gastroesophageal reflux had nothing to do with the hep b vaccine. No further details were provided. Y Y Y serum direct bilirubin 20 units OTH OTH UNK UNK WAES01042680 1
0169531 05/08/2001 IN 57.0 57 F 05/03/2001 Information has been received from a health NP concerning a 57 year old female, who on 4/18/01, accidentally received pneumococcal vaccine 23 polyvalent IV with renal failure and receiving dialysis 3 times a week for several years. The reporting NP stated that the pt was receiving dialysis and was scheduled to received several medications including epotin alfa (Epogen) and peucalcitol (Zemplar) during her dialysis. The pt was also scheduled to be vaccinated with pneumococcal vaccine 23 polyvalent since her last vaccination was in 9/94. It was reported that the nurse picked up the pneumococcal vaccine 23 polyvalent and administered the medication IV. The NP stated that the epotin alfa syringe and the pneumococcal vaccine were in the same size syringe. Subsequently, on the same day, 4/18/01, the pt experienced chest pain and was admitted to the hospital. A stress test was positive and results from an angiogram is still pending. Subsequently, the pt recovered from chest pain and on 4/24/01 was discharged from the hospital. On 4/25/01, the pt was in for a dialysis treatment. Additional information has been requested. Y Y 04/18/2001 04/18/2001 0 Angiography-pending; cardiac stress test-positive UNK UNK Epogen, Zemplar Hemodialysis; renal failure WAES01042289 1
0169533 05/08/2001 CA 11.0 F 05/03/2001 Information has been received from a physician concerning an 11 year old female pt who on 4/24/01 was vaccinated with Hep-A virus vaccine inactivated. There was no concomitant medication. On 4/26/01, the pt presented to the office with severe muscle pain throughout her body, she could not move or walk. When the child tried to move it hurt so bad she cried. The child had a temperature of 100F and her blood pressure and pulse were normal. Additional information has been requested. Upon internal review, gait abnormality and movement disorder were determined to be "Other Medical Events". U 04/24/2001 04/26/2001 2 Blood pressure-nml; Temperature-100F; Pulse-nml OTH OTH NONE NONE WAES01042672 1
0169535 05/08/2001 IL 0.2 0 .2 M 05/04/2001 Information has been received from a physician concerning a healthy 9 week old pt with no known allergies who on 2/7/00 was vaccinated with haemophilus b conjugate vaccine + hepatitis b vaccine recombinant (yeast). Concomitant vaccinations on 2/7/00 included poliovirus vaccine inactivated and diphtheria toxoid/pertussis vaccine/tetanus. On 2/10/00, the pt experienced angioedema, affecting all 4 extremities, fever, irritability and soreness. The pt recovered after 2 weeks of steroids. The pt had a similar experience following exposure to MMRII (WAES01050238). Upon internal review, the pt's experiences were considered to be "Other Medical Events". Additional information ha been requested. Y Y 02/07/2000 02/10/2000 3 OTH OTH UNK Angioedema and serum sickness~Measles + Mumps + Rubella (MMR II)~1~1.00~In Patient WAES01042108 1
0169536 05/08/2001 AL M 05/04/2001 Information has been received from the mother of a male child with no known allergies and no medical history who was vaccinated with MMRII a few years ago. There was no concomitant medication. Subsequently, the pt experienced "seizures from the medication" that lasted through the entire evening. The mother noted the child had not been the same since and was a little slow in learning things. It was reported that the child sought unspecified medical attention. Additional information has been requested. Upon internal review, seizure and learning impairment were determined to be "Other Medical Events". N OTH OTH NONE NONE WAES01042666 1
0169537 05/08/2001 IL 1.0 1 .1 U 05/18/2001 Information has been received from a physician concerning a 12 month old pt who on 1/3/01 was vaccinated with MMRII. On 1/6/01, the pt experienced severe angioedema with a serum sickness-like component. The pt was treated with prednisolone sodium phosphate (Pediapred) 10mg po bid for 2 weeks and recovered. The pt had a similar experience following exposure to MMRII (MSD) (WAES 01042108). Upon internal review the pt's experiences were considered to be "Other Medical Events". Additional information has been requested. Y Y 01/03/2001 01/06/2001 3 OTH OTH UNK Previous reaction with MMRII Angioedema, fever, irritability and pain~Hib + Hep B (Comvax)~~0.00~In Patient WAES01050238 1
0169540 05/08/2001 GA 11.0 11 F 04/05/2001 On 4/5/01 at 05:00, mother reports nausea and vomiting X 3 episodes, by 11:00 AM, face with fine prickly rash, blue color to face. Admitted to hospital from approx. 12:00 to 14:00. Mother reports that doctor stated it was "effects of immunization". Annual follow up on 11/03/2003: "Follow up was attempted in 07/2002. We were unable to locate the patient. Please see attached info which was transmitted to VAERS on 08/09/2002. Patient unknown to health department for any visits other than 1 visit of 04/14/2001. Phone # disconnected. Physiican retired." Y Y U 04/04/2001 04/05/2001 1 Labs done at hospital PUB PUB NONE Sinus, Allergy symptoms. NONE GA01031 1
0169541 05/08/2001 GA 0.5 0 .4 M 04/10/2001 Dad reports on the evening he received shots, he stopped eating and had diarrhea and fever. He was taken to ER and was admitted to the hospital. Call to pediatrician, states not related to shots. Diagnosed with acute gastroenteritis and dehyration. Y 3 Y 03/09/2001 03/09/2001 0 PUB PUB NONE NONE Asthma GA01032 1
0169542 05/08/2001 CA 0.2 0 .2 M 03/27/2001 This infant had diarrhea,and vomiting after receiving DTaP, Polio, Prevnar, HIB, and HBV on 03/08/01. He was admitted to the hospital 03/09/01. Elevated potassium, low blood sugar, and swollen liver. Y Y 5 Y 03/08/2001 03/09/2001 1 Elevated potassium; low blood sugar; swollen liver PVT OTH NONE NONE 1
0169543 05/08/2001 SC 1.5 1 .6 M 04/26/2001 This child was "fussy all day", "felt hot", legs were sore, (no temp taken until 8 PM). At 8 PM, temp of 100, gave Tylenol, injection sites were "hard and hot" at 8 PM. At 10 PM, his temp was 103, he was taken to the hospital. At Midnight, his temp was 104.6 at the hospital, they gave him Motrin, 10 minutes later he had a seizure. He was hospitalized. 60 day follow up on 11/04/2003: "Vaccine recipient did recover from adverse event." Y Y 2 U 04/25/2001 04/25/2001 0 PUB PUB NONE NONE NONE SC0126 1
0169544 05/08/2001 DC 32.0 32 M 05/02/2001 7/1/00 with Hep-A vaccine #1, developed rash at injection site; 3 weeks later, resolved. Progressive myalgias and heliotropic rash 9/00 to 10/00. Dx'd with dermatomyositis and ATN (acute tubular necrosis). Y 10 Y 07/26/2000 08/10/2000 15 (-) acute hepatitis profile on 10/00; increased serum creatine; increased CPK MIL MIL NONE NONE NONE 1
0169545 05/08/2001 TX 5.0 5 M 05/02/2001 About 1 1/2 weeks after receiving immunizations, the patient had a seizure while riding in a car. He was taken to the ER and had another seizure. He stayed in the hospital about 4 or 5 days. Tests were done and he was put on medicine, which seemed to help lessen the seizures for a while, but would then become more frequent. Meds were changed and again seizures would lessen for a while, but then come back again. Meds were changed several times, with the same results. Around the 1st of January 2001, he was put on the ketogenic diet with almost instant cessation of seizures, except for small 'tics" which he continues to have. He is now on only one med (Zonegram). The mother gives history of the patient falling on the kitchen floor and hitting his head about two months prior to onset of seizures. She states she gave him Tylenol for the headache, but did not go to a physician at the time. She also states doctors are unsure if immunizations are connected to his seizures. doc 214099, annual follow up states the following:"05/13/2002, mother states that patient continues with diet and medications plus has had seizures since 04/2001. She states that physician did not want patient to be on the diet for more than 2 years, which will be up in 11/2002. She states that the physician plan to try taking him off the diet at that time. She thinks the patient is a little too small for his age + gets a little more tired than before but lives a "pretty well normal" life + even plays T ball. Per follow up Pt has not recovered. 12/16/2002 father states pt had recent EKG whiched showed "slowness in brain". Is no longer having tics and is continuing on Zonegram 100mg. Still on ketoganic dish, but is to be weaned off innext 2-3 months and within 6 months hopes to be eating normally. Says he has gained some weight and is now in a gymnastic class. Seizure disorder now better controlled with Ketogenic diet taking Titralac, Bug Bunny Vitamins, Zonegran. Repeated ear infection, tubes placed @ 18 months of age. Dx made at ER: facial muscle twitching, decreased responsiveness. Early 11/2000 child slipped and fell hitting back of head(?) Had HA for 4-5 hours. No further HA reported. Hospitalized 2 days @ 8 months of age for high fever and dehydration. 3rd hospital admission 01/08/2001 - 01/11/2001 for ketogenic diet instition records were obtained Y Y N 09/28/2000 10/09/2000 11 Test done in hospital PUB PUB NONE NONE NONE 1
0169546 05/08/2001 ID 20.0 20 M 04/09/2001 Fever of 105F; decreased slightly with Tylenol (given X1). By 08:00 AM, father concerned that son had a seizure. MD visit and admitted to the hospital for observation. Pt had slight diarrhea. Parent states client had a headache the morning of 4/4/01 but was well at the time of shots. No seizure noted in the hospital. Parent states client was aphasic for a short time. Discharged without dx of symptoms and clear tests. Y 1 Y 04/04/2001 04/06/2001 2 R/O meningitis, R/O bacterial or viral infection, R/O stool culture PUB PVT NONE Mild mental retardation secondary to pre-term birth ID01018 1
0169548 05/08/2001 GA 0.2 0 .1 M 05/04/2001 Five days, post vax, child became febrile. Seen at hospital. On 4/24/01, after septic work-up; LP and blood cultures, child was discharged on 4/26/01. Dx'd with ? viral illness. Child discharge shows viral illness/fever. Y Y 2 Y 04/19/2001 04/23/2001 4 LP; Blood Cultures; CBC with differential-all WNL PVT PVT NONE NONE 1
0169549 05/08/2001 TX 1.8 0 .7 M 05/04/2001 The pt experienced a severe local reaction where the left thigh and the right thigh had discoloration. Y Y 04/19/2001 04/20/2001 1 NONE PVT UNK NONE NONE NONE 1
0169550 05/08/2001 PA 3.0 3 M 05/04/2001 One day post vax the pt complained of right arm redness and warmth. On 5/4 the pt was seen by a medical care associate. The right upper extremities / shoulder was erythematous and indurated with warmth and tenderness to the touch. The pt had blister formation and was referred to hospital. Y U 05/02/2001 05/03/2001 1 NONE PVT PUB NONE NONE eczema 1
0169551 05/08/2001 NJ 3.0 3 F 05/04/2001 The pt experienced a 3x4 cm area of swelling and erythema inferior to injection site vaccine reaction with cellulitis. treated with Augmentin and Benadryl. Y 04/25/2001 04/26/2001 1 NONE PVT PVT PPD NONE NONE 1
0169552 05/08/2001 WI 0.5 0 .6 M 03/23/2001 The pt's right leg where the vaccine was given turned deep red/purple with scattered hive like areas noted. Y 03/23/2001 03/23/2001 0 PUB PUB cold WI0121 1
0169553 05/08/2001 ID 0.6 0 .6 F 04/11/2001 The pt developed a fever of 104, shaking movements and staring spells. Tylenol and Motrin were given. Y Y 04/10/2001 04/11/2001 1 EEG - nml PVT PUB NONE NONE ID01016 1
0169554 05/08/2001 ID 0.2 0 .2 M 03/21/2001 The pt experienced a "scream" type cry for greater than 3 hours. Y 03/19/2001 03/19/2001 0 PUB PUB NONE NONE ID01020 1
0169555 05/08/2001 GA 0.5 0 .5 F 04/03/2001 The pt experienced red blotches over the extremities and body. The baby was lethargic and afebrile. Y Y 03/27/2001 03/30/2001 3 PUB PUB NONE NONE GA01030 1
0169556 05/08/2001 MO 1.25 1 .3 U 04/26/2001 The pt received the vaccines on 4/13/01 and on 4/22/01 woke from nap with rash on cheeks, stomach and bottom. Mother consulted physician and felt like it was probably due to MMR vaccine. Y 04/13/2001 04/22/2001 9 NONE PUB PUB NONE NONE NONE MO2001024 1
0169557 05/08/2001 NM 0.5 0 .5 F 04/27/2001 Mother called to say that the child had a fever approximately 24 hours post vax to 101. Given Tylenol every 6 hours and had decreased. Y 04/25/2001 04/25/2001 0 PUB PUB Tylenol NONE NM030001 1
0169558 05/08/2001 MI 0.2 0 .2 M 04/10/2001 Presented in ER with right leg redness (small amount). Mother states baby crying and choking. Temperature is 99.8F. Dx'd with slight local reaction to right leg. Y Y 01/16/2001 01/17/2001 1 NONE PVT PUB NONE NONE NONE MI2001032 1
0169559 05/08/2001 MO 1.4 1 .4 F 04/25/2001 Child received vaccines on 4/18/01 and on 4/24/01 AM, developed fever and then a seizure. Was taken to hospital by EMS and dx'd as probable febrile seizure. Thought to have viral illness. Still fever today. Y U 04/18/2001 04/24/2001 6 CBC; UA; Spinal Tap; Blood cultures-all neg PUB UNK Tylenol elixir NONE NONE MO2001023 1
0169560 05/08/2001 OH 0.8 0 .9 F 04/24/2001 Vomiting Y 04/09/2001 04/09/2001 0 UNK UNK NONE NONE Vomiting~Pneumo (Prevnar)~1~0.70~In Patient 1
0169561 05/08/2001 CA 1.7 1 .7 F 05/02/2001 9cm X 5cm firm, fluctuant swelling on right thigh with surface erythema. No marked tenderness. U 05/01/2001 05/02/2001 1 NONE PVT PVT NONE NONE NONE 1
0169562 05/08/2001 CA 1.5 1 .4 M 04/27/2001 Mom described red and swollen left thigh, 1 week after receiving 4 vaccines in left thigh with generalized rash. No fever and swelling resolved. MD observed thigh, 3 weeks after injections and swelling was resolved. Y 04/06/2001 04/16/2001 10 PUB PUB CA010041 1
0169563 05/08/2001 MN 1.3 1 .4 F 04/27/2001 Pt's mother called our phone center seeking advice because pt had a fever, was having some jerking of extremities and wouldn't walk. Referred to ER by triage nurse. Found to have a temperature of 106F and rigors. Treated with antipyretic with symptom resolution. Y Y 04/25/2001 04/26/2001 1 NONE PVT PVT NONE NONE NONE 1
0169564 05/08/2001 CA 2.0 2 .2 M 04/11/2001 Pt received Prevnar vaccine in right thigh on 4/9/01. Pt returned to clinic on 4/11/01 with a hard knot, redness and swelling. Pt was limping. Dx'd with cellulitis. Y Y 04/09/2001 04/10/2001 1 NONE OTH OTH 1
0169565 05/08/2001 NY 0.2 0 .2 F 04/23/2001 Slept and nursed well during the night, post vax, but the whole next day, was irritable, barely slept, barely nursed and had 1 period when she lay awake but was abnormally still. Seen in ER in the evening; irritable, drowsy but nursed some and interacted well. Did not behave normally again until 09:00 on 3/25/01. Y Y 03/23/2001 03/24/2001 1 NONE PVT PUB Acetaminophen after reaction started on 3/25/01. NONE NONE 1
0169566 05/08/2001 PA 0.4 0 .2 F 05/01/2001 Approx. 1 hour, post vax, child cried inconsolably. Mom called us after 3 1/2 hours (at 16:30 PM). She was told to give Tylenol and call back within the hour. Pt continuing to cry until 20:00 when family sent to ER. Temperature was 100.4F. Child did not stop crying until 03:00. Y Y 04/30/2001 04/30/2001 0 PVT PUB 29 week preemie 1
0169567 05/08/2001 CA 0.08 0 .1 F 04/27/2001 Pt tolerated 6 week shots well. Went home with mom. On 4/25/01 at 15:42, per mom, pt had non-stop crying since 4/23/01. No fever, but inconsolable. Can hear baby in the background, screaming and crying. MD suspects "pertussis" of DTAP. Resolved on 4/26/01, per mom. Y 04/23/2001 04/23/2001 0 PVT PVT Mild cold symptoms 1
0169568 05/08/2001 OH 1.25 1 .3 M 04/30/2001 Maculo papular rash on trunk, proximal extremities. Y Y 04/12/2001 04/23/2001 11 PVT PVT NONE NONE NONE 1
0169569 05/08/2001 NH 1.0 1 .0 F 04/27/2001 This infant had localized swelling, mild, sterile abscess of the left thigh. Y 04/25/2001 04/26/2001 1 NONE PVT UNK Fluoride NONE NONE 1
0169570 05/08/2001 SC 42.0 F 11/29/2001 Report 2001010763-1 describes tingling and joint swelling in a 42 year old female who received Lyme disease vaccine recombinant OspA (Lymerix). This report was received from the patient and has not been verified by a physician or other health care professional. The patient has no known drug allergies. There were no concurrent medications. She has no history of gout, psoriasis, or Crohn's disease. She has no family history of rheumatoid arthritis or systemic lupus erythematosus. The patient is an avid hiker. She reported that she removed three or four ticks from her legs in 1999. Within hours of removing the ticks, she developed two bull's eye rashes on her right leg, one bull's eye rash on her left leg, and flu-like symptoms. She contacted her physician, who made a diagnosis of Lyme disease and prescribed "high doses of antibiotics." The patient was not seen by the physician, and no diagnostic evaluation was performed. The patient's symptoms resolved. Subsequently, the patient self-administered three doses of Lymerix on unspecified dates. In November 2000, she began to notice tingling of both arms and hands, which then became numb. She also developed "edema in all digits' and pain and swelling of both knees. She was referred to a rheumatologist in January 2001. The rheumatologist reportedly noted edema of the hands and fluid in the patient's right knee. No joint fluid was obtained. None of the patient's joint's were red or warm. The patient reported that erythrocyte sedimentation rate (ESR), antinuclear antibody (ANA) titer, and C-reactive protein (CRP) were measured on an unspecified date; results were not provided. Rheumatoid factor was reportedly measured on different occasions; the patient stated, 'Rheumatoid showed up low and sometimes did not show up at all". As of 04/26/01, the patient stated that she had swelling in both hips and both knees. She reported that her joint pain had worsened. Treatment of the joint pain and swelling was not specified. The treatment and outcome of the tingling, numbness, and edema of the digits were not specified. The adverse events of tingling, numbness, knee pain, and joint swelling do not meet ICM serious criteria, but are being submitted as an expedited report by special FDA request per the June 28, 2000 letter. Additional info was received from the vaccine provider on 11/14/2001. The pt first presented to the vaccine provider on 12/29/2000 with chief complaints of numbness of both hands and arms and dizziness. The pt reported that the numbness began two weeks prior to the office visit, occurred while sleeping, and was aggravated by driving. She reported that the dizziness began on the morning of 12/28/2000. She characterized the dizziness as "mild." It was aggravated by movement and relieved by Antivert. At the time of the office visit, the pt was taking Celexa daily for an unspecified indication and Antivert four times daily as needed to relieve dizziness. On review of systems, the pt reported rhinits. On physical examination, her tympanic membranes were intact and there was no postnasal drip. The physical examination was normal. The physician's assessment was "vertigo, numbness." The physician prescribed Aleva and Claritin-D. The pt presented to the vaccine provider on 01/08/2001 with complaints of hand numbness and joint pain and stiffness. The affected joints were not specified. The pt reported that the joint pain and stiffness began two weeks prior to the office visit. She described the joint pain and stiffness as "moderate" and aggravated by changing position and standing. Under review of systems, the physician noted that the pt "denies joint or tingling." On physical examination, no abnormalities were noted. Specifically, no swelling or redness of joints or digits was noted. No tenderness was noted on palpation of any jont or digit. The physician's assessment was "arthralgia." He discontinued therapy with Aleva and dyazide, and prescribed Vioxx. The pt was seen by the vaccine provider on 05/02/2001. At that time, she complained of "severe" joint pain and was concerned about Lyme disease. She reported that Vioxx did not provide any relief for the joint pain. The physician's assessment was "arthralgia, unchanged." The vaccine provider referred the pt to an infectious disease specialist. The most recent info received from the vaccine provider on 11/14/2001, indicated that the arthralgia persisted as of 05/02/2001. Outcomes of the tingling, numbness, edema in the digits, joint swelling and stiffness, and vertigo were not provided. The adverse events of tingling, numbness, vertigo, arthralgia, joint swelling, and joint stiffness do not meet serious criteria, but are being submitted as an expedited report. Y U Rheumatoid Factor - "Low" 2001. Rheumatoid Factor - Negative 2001. ESR - results not provided. ANA Titer - results not provided. CRP - results not provided. PVT PVT Celexa, Dyazide Lyme disease, allergic to codeine, gastrointestinal upset, two bull's eye rashes on her right let, one bull's eye 20010107631 1
0169571 05/08/2001 IA 69.0 69 M 05/04/2001 On 4/29/01, two days post vax, the pt experienced dizziness and stiffness in his legs. No treatment was given. The pt was unsure if the adverse events were related to Lymerix. As of 4/30/01, the outcome of the events was ongoing. F/U there was no illness at the time of the vaccination. The pt did not have gout, psoriasis or crohn's disease. There was no family history of rheumatoid arthritis or lupus. The pt did not have a history of lyme disease. As of 6/13/01, the responsible physician stated that the pt had not been seen for the above-listed adverse events. He did not call or inform our office about any adverse reaction to the injection. The joint complaints were not evaluated by a physician. Swollen joints had nto been documented on physicial exam. Lab work was not performed. Joint fluid was not obtained. As of 6/14/01, the outcome of the adverse events was unknown. Dizziness does not meet ICM serious criteria, but are being submitted as an expedited report by special FDA request per the 6/26/00 ltr. N 04/27/2001 04/29/2001 2 PUB PVT Zocor, Lotril bulls-eye rash, elevated cholesterol, hypertension, history of Lyme disease 20010109081 1
0169572 05/08/2001 PA 49.0 49 M 04/30/2001 Arthritis pain in various joints, severe, much of the time, over the past year. More severe for the past 5 months. Also, numbness and tingling, especially in hands and arms. Presently taking Celebrex. Y N 11/02/2000 12/01/2000 29 ESR, RF, ANA-all neg; CBC, Iron-both nml; Western Blot-pending; HLA-DR4-pending PVT UNK NONE NONE Lactose intolerance; occasional prostate enlargement 1
0169573 05/08/2001 MN 53.0 51 M 05/01/2001 Just like having Lyme disease only it went after the large joints; knees, ankles, back and neck. N 05/27/1999 Have just had tests done but don't have results back yet. PVT PUB NONE 1
0169574 05/08/2001 CA 29.0 28 M 05/02/2001 The morning following vaccination, pt lost all feeling and movement in left arm for approx. 30 minutes. Experienced slow recovery over following hour. Pt has submitted this due to resistance from Navy doctor's to document and submit this adverse report. Y 12/17/1999 12/18/1999 1 MIL MIL NONE NONE NONE 1
0169575 05/08/2001 MI 50.0 F 04/09/2001 Telephone call received from agent to field supervisor stating she received flu shot on 12/26/00 and had a seizure on 12/30/00. History of meningioma surgery removed but off since then. Seizure meds. Called PP who stated no correlation to flu shot but restarted her on seizure meds. (Tegretol). No further seizures since that date. Y Y 12/26/2000 12/30/2000 4 PUB PUB Lipitor; BP meds Lipitor for increased cholesterol and BP meds MI2001030 1
0169576 05/08/2001 MI 52.0 52 F 04/03/2001 Telephone call received on 3/21/01 from client to clinic PHN stating she has continued to experience muscle soreness and some weakness of left arm off and on since receiving flu shot on 1/2/01. Saw her doctor who stated there was no infection and did not order any meds. Returned call from supervisor on 4/1/01. Client's arm is "gradually getting better" but still bothersome. Suggested comfort measures and to return to doctor if condition worsens. Y Y 01/02/2001 01/03/2001 1 PUB PUB MI2001031 1
0169577 05/08/2001 TX 45.0 44 F 05/01/2001 Have had pain in left arm (muscle soreness) since receiving flu shot on 11/28/00. Pain is present on upward movement of arm and worse with lifting or pushing. U 11/28/2000 11/28/2000 0 UNK UNK Chronic lymphocytic leukemia Muscle soreness~Influenza (Seasonal) (no brand name)~~0.00~In Patient 1
0169578 05/08/2001 TX 25.0 25 F 05/04/2001 Pt found out she was pregnant after receiving the MMR and TD vaccine on 3/29/01. She was counseled at time of visit to avoid pregnancy for 3 months. Y 03/29/2001 04/01/2001 3 PUB PUB NONE 1
0169579 05/08/2001 MO 4.0 4 F Raised red area, approx. 4" X 1" on left deltoid. Y 05/02/2001 05/04/2001 2 NONE PVT PVT NONE NONE 1
0169580 05/08/2001 CA 39.0 39 M 04/27/2001 The pt complained of elevated temp, chills, pain at the deltoid radiating to the elbow of left arm and inability to move arm. Erythema from deltoid to mid upper extremity, hot, tight skin, finger edematous and painful to touch. Two small bumps on each side of injection site. No oozing or drainage. 80mm of erythema and swelling in length. Y U 04/24/2001 04/25/2001 1 PUB PUB PPD NONE UNK CA010039 1
0169581 05/08/2001 CA 4.0 4 F 04/26/2001 Mother brought pt in for rash on left arm. No temperature. Rash since yesterday. Y 04/19/2001 04/25/2001 6 UNK UNK NONE 1
0169582 05/08/2001 TX 4.0 4 F 05/03/2001 Left leg red and swollen, 3 days, after immunization. Y 04/13/2001 PVT PVT 1
0169583 05/08/2001 NY 33.0 32 F 03/26/2001 Transient hemi-anesthesia A follow up report received 01/22/2003 adds: It was reported that a female pt was given a post exposure series of Imovax Rabies for bat exposure. Pt experienced "flu-like" symptoms after 2nd and 3rd doses. On 02/18/2001 the pt developed numbness in left side of face, ear, arm and calf, no sensory perception in left side, now in right side. Was seen in ER on 02/18/2001, CAT scan done. Referred to neurologist and ENT doctor, MRI done, all reports sent to primary care physician. Unresolved, getting worse. Per Aventis Pasteur Inc. Medical Safety Officer's conversation with primary care physician on 02/28/2001, it was stated that the neurologist evaluated the pt and made a diagnosis of hemianesthesia. From additional correspondence received on 05/07/2001, additional laboratory data was provided. From follow-up #1 mailed correspondence received on 06/12/2001 stated, "Reviewed, nothing to add at this time. This case is closed. U 01/17/2001 02/10/2001 24 Normal labs; MRI; Ssep PVT PVT Rabies Immune Globulin/R06142/Pasteur Merieux/IM/RA & LA Hemi-anesthesia 1
0169584 05/08/2001 WI 5.0 5 F 03/01/2001 TC from pt, stating child had a rash on back area, 1 hour, post vax. Told to call MD. When RN called back, client to follow-up on condition. Parent denied rash ever present or TC made to RN; did no visit MD. Y 02/19/2001 02/19/2001 0 PUB PUB Clonidine for sleep NONE Sleep disorder; ADHD; Behavior problems WI0122 1
0169585 05/08/2001 ID 29.0 29 F 04/19/2001 Immediately, post vax, pt's color was pale, palms sweaty, arms felt swollen, complained of dizziness and weakness. Symptoms continued on 4/18/01 and 4/19/01. Took 24 hour Allegra which seemed to help. Lips, hands and throat were itchy. Still feels dizzy today on 4/19/01 but improved. Y 04/17/2001 04/18/2001 1 NONE PUB PVT Glucophage 500mg qd; albuterol prn NONE Asthma; polycystic ovaries ~Hep B (no brand name)~1~21.00~In Sibling ID01015 1
0169586 05/08/2001 ID 12.0 12 M 03/07/2001 On 1/19/01, pt noticed 1st pox but by 1/20/01, covered in pox with fever of 103F. Temperature was 100F-101F on 1/21/01. Denies contact with infected individuals. Chickenpox covered body. (Vesicular lesions scabbing over in 3-4 days). Y 01/16/2001 01/19/2001 3 NONE PUB PUB NONE NONE NONE ID01017 1
0169587 05/08/2001 ID 39.0 39 F 04/03/2001 On 2/23/01, 48 hours, post vax, client was found passed out in bathtub by father. Paramedics called. Glucose given. Two days, after this incident, client could not move entire left side for about 5 minutes. Diabetic-AM blood sugar 118. States "paramedic blood sugar was 28, after above episode." Y Y 02/23/2001 02/25/2001 2 Blood sugar-28 PUB UNK Type I Diabetes; allergy to PCN, Iodine, tetracycline ID01019 1
0169588 05/08/2001 GA 15.0 15 M 04/27/2001 11/00, client experienced nausea and vomiting. Put on Phenergan, then suppositories. 12/00, put on Tigan. 2nd Hep-B vaccine on 1/2/01, ENG5159A2/IM/LA, still nausea and vomiting. Did upper GI, gallbladder U/S and blood work-all normal. Remained sick. On 4/01, started on Prilosec and Pepto-Bismol, 1 tsp. bid with Prilosec. Mom states child would have weeks where he was better but would relapse. 3rd Hep-B ENG5184A9/IM/LA, given on 4/12/01 and is experiencing same nausea and vomiting starting on 4/23/01. Mom thinks it is a side effect from Hep-B vaccine series. Y U 10/29/2000 11/01/2000 3 Blood work; Upper GI and gallbladder ultrasound-all nml PUB PUB NONE Proteus Syndrome GA01037 1
0169589 05/08/2001 GA 0.6 0 .6 F 04/09/2001 Mother brought child to clinic on 4/9/01 "for shots". Mother stated that the pt developed "hives and a rash" about 5-6 hours, post vax. Mother stated pt did not have a fever. She took pt to the Medical Center for evaluation. The ER doctor told her that the DTAP vaccine caused the "hives and rash". Mother does not recall any specific treatment. She reported reaction to Peds. Y Y 11/07/2000 11/07/2000 0 NONE PUB PUB NONE NONE NONE GA01036 1
0169590 05/08/2001 GA 4.0 4 M 04/10/2001 Left arm where IPV and DTAP were given, very red and swollen from upper arm to elbow. Swollen area is hard and arm is warm to touch. Mom states has been running a fever. Child is complaining of itching. Called on 4/11/01 and mom stated no complaint of itching, swelling or redness but some fever. Saw Pediatrician on 4/10/01 and dx'd severe local reaction. No treatment given and to return if worsens. Y U 04/09/2001 04/10/2001 1 PUB PUB NONE NONE NONE GA01035 1
0169591 05/08/2001 GA 15.0 15 M 03/21/2001 Received shots approx. 11:00. Parent called and reported swelling of eyes with matting. Advised to go to EMT substation immediately, EMT's alerted and reported back that child over-reacted and anxious. On 3/21/01 spoke with parent and reports problems with throat through the night. Eye and tongue swollen. Y 03/20/2001 03/20/2001 0 PUB PUB NONE NONE GA01033 1
0169592 05/08/2001 IA 41.0 41 F 04/27/2001 Pt received TD booster as routine shot on 4/13/01. On 5/24/01, she noticed an electrical "zinging or zapping" sensation going down her arms. This comes and goes. Starting 5/26/01, she noticed more itching and cramping in her (B) arms and hands. I spoke with doctor on 5/25/01 and he recommended conservative therapy and monitoring of symptoms. Pt to call me if symptoms do not resolve in 2 weeks. U 04/13/2001 04/24/2001 11 NONE PVT PVT 1
0169593 05/08/2001 CA 12.0 12 M 04/29/2001 At 10:05, post vax, pt looked pale and he's dizzy. I had his head down. At 10:10, had him lie down. BP 90/60; HR-66/min. reg. No SOB or chest pain. Pt diaphoretic. At 10:20, BP 90/70; HR-90/min. reg. Skin and lip color pink, pt states not dizzy anymore. Feeling fine and left stable. Y 04/24/2001 04/24/2001 0 NONE PUB PUB NONE NONE NONE CA010040 1
0169594 05/08/2001 NJ 4.0 4 F 04/11/2001 The pt experienced a rash, and hives on arm with swelling the diameter of a small orange. Now swelling is gone and it appears to be a dry occasionally itchy rash. (As stated by mom.) Y 04/04/2001 04/04/2001 0 PVT UNK insulin diabetes 1
0169595 05/08/2001 MS 1.25 1 .2 F 05/01/2001 Received a call from the mother that the child was taken to the ER by ambulance on 4/27/01 and diagnosed with febrile seizures. Mother recalls being instructed to give Tylenol every 4 hours for 24 hours but stated that she did not do so. The child was discharged on Motrin and Ceftroxil. Mother denies any allergies or medical complication. Y Y 04/26/2001 04/27/2001 1 PUB PUB NONE NONE MS01014 1
0169596 05/08/2001 MO 1.25 1 .7 M 04/20/2001 One day post vax, the pt had edema, hives and fever. The fever went to 100 and started at 9:00pm on 4/16/01 and the hives and edema by next day. Hives were from the waist down. Right hip is swollen and red. Y Y 04/16/2001 04/17/2001 1 NONE PUB PUB NONE NONE NONE MO2001025 1
0169597 05/08/2001 MO 3.0 3 F 04/24/2001 The pt complained of extreme swelling with the arm 3 times the normal size. No increased temp. Seen in the ER on 4/6/01 PM. Places on antibiotics. Told had infection from shot. Called her mother on 4/9/01 she states arm remains swollen. States he told her shot should have been in leg and not deltoid. On 4/10/01 mother states the pt is on antibiotics. On 4/13/01 it is reported that the arm is blistered down to the elbow. On 4/24/01 is completely healed. Y Y 04/06/2001 04/06/2001 0 PUB PUB NONE NONE MO2001026 1
0169598 05/08/2001 NJ 4.0 4 F 05/01/2001 The pt experienced swelling 6cm x 4cm to the left arm with erythema and mildly warm to the touch. U 04/30/2001 04/30/2001 0 PVT UNK 23 week premature baby 1
0169599 05/08/2001 IL 26.0 26 F 04/26/2001 The pt experienced rashes and itching. Y Y 04/23/2001 04/23/2001 0 PVT OTH NONE 1
0169600 05/08/2001 NY 1.5 1 .5 F 05/04/2001 The pt experienced complete upper arm left deltoid redness, a hard lump and warmth to the touch. No change in activity level. Y 04/30/2001 05/01/2001 1 NONE PVT PVT NONE NONE 1
0169601 05/08/2001 CA 30.0 30 M 04/27/2001 The client called to report adverse events 24 hours post administration of vaccine on 4/24/01. The pt complained of malaise, weakness in hands and fever. The pt had not taken temp so was unsure what it was. U 04/23/2001 04/24/2001 1 NONE PUB PUB NONE NONE NONE 1
0169602 05/08/2001 WI 5.0 5 M 05/01/2001 The pt experienced hives from the upper arm to wrist of the left arm. He made the statement "I need to get air". The pt was less alert and experienced a low grade fever. Y Y 04/30/2001 04/30/2001 0 PUB PUB NONE NONE NONE Rash~Measles + Mumps + Rubella (MMR II)~1~1.00~In Patient 1
0169603 05/08/2001 CA 4.0 4 F 04/30/2001 The pt experienced a red rash on her arms, legs, back, and chest. Benadryl was given. Y 04/30/2001 04/30/2001 0 OTH UNK PPD NONE 1
0169604 05/08/2001 TX 10.0 10 F 04/26/2001 The pt experienced a erythema at the injection site approximately 2.5 cm in diameter. Y 04/25/2001 04/26/2001 1 PUB PUB laceration 1
0169605 05/08/2001 MA 12.0 13 F 04/22/2001 Following vaccination, the pt fell off the exam table hitting head on floor and arms, legs and stomach were shaking (seizure) with LOC, lasting approximately 5 seconds. BP 100/70, HR 80. Ice applied, had normal neurological exam after incident, normal cardiac exam. Ice applied to face. Y 04/12/2001 04/12/2001 0 EKG - results pending PUB PUB albuterol inhaler NONE mild intermittent asthma 1
0169606 05/08/2001 NH 8.0 3 M 05/01/2001 The pt developed a headache, low grade temp and red spots all over body. No treatment was given. Y 12/28/1995 04/30/2001 1950 PVT PUB 1
0169607 05/08/2001 TX 1.8 1 .8 F 04/30/2001 The pt complained of redness, swelling (about 3 inches surrounding injection site) pain to left upper thigh. U 04/28/2001 04/29/2001 1 NONE PVT PUB NONE NONE 1
0169608 05/08/2001 CT 7.0 6 M 04/30/2001 The pt experienced respiratory distress, nasal flaring, O2 sat at 94%, erythema at the injection site and abdomen, erythema and swelling of bilateral eyelids and neck. Respiratory rate is 60 with inspiratory and expiratory wheezing. Y Y 04/30/2001 04/30/2001 0 PVT PUB albuterol, pulmocort NONE asthma 1
0169609 05/08/2001 VA 56.0 56 F 12/05/2000 5 days post vax the pt experienced arthralgias, myalgia's, fatigue, low grade fever persistent for 1 week. Symptoms resolved completely. Y Y 11/01/2000 11/05/2000 4 CBC, Chem 7, CPK, ESR - nml MIL MIL NONE URI seasonal rhinitis 1
0169610 05/08/2001 AZ 3.0 3 F 05/04/2001 The pt experienced an upper left arm with redness and swelling from shoulder to elbow and under arm to axilla. Treated with Benadryl. U 05/02/2001 05/03/2001 1 PVT PVT Rynatan, Nasonex allergies allergies 1
0169611 05/08/2001 CA 33.0 34 F 04/27/2001 The pt complained of pain and itching at the injection site on the left deltoid. The site was red and warm circle around injection site that was 20mm in width. No complaint of fever, chills and no drainage at site. Y 04/24/2001 04/25/2001 1 NONE PUB PUB PPD NONE UNK CA010038 1
0169612 05/08/2001 NH 31.0 31 M 05/02/2001 The pt experienced a localized reaction at the left deltoid injection site with warmth to the touch, painful movement and localized deltoid swelling. Worsens each day. Has not tried anti-inflammatory or other over the counter medications or used heat/cold. Y U 04/25/2001 04/26/2001 1 PUB PUB vitamin B6, INH NONE class 2 tuberculosis 1
0169613 05/08/2001 FL 42.0 42 F 05/01/2001 Following vaccination, the pt began to have cold symptoms on 4/20, 4/21. Then on 4/27/01 the pt began to have a rash and fever. Fever was present on 4/28 as well. On 5/1/01 was present with generalized red slight raised rash. The rash is itchy. Treated with Benadryl and Caladryl. BP was 124/80, T - 99.2, P-80, R-16. U 04/19/2001 04/23/2001 4 OTH PUB NONE allergy to iodine 1
0169614 05/08/2001 IL 14.0 14 M 04/26/2001 Within 1 minutes the pt exhibited a generalized seizure, eyes rolled back, BP 70/38 and pulse faint. The pt was cool and clammy with mild diaphoresis, and paleness. Seizure lasted 30-45 seconds, Pt was responsive. 911 and the parent called. The pt was taken to the ER. Y N 04/24/2001 04/24/2001 0 OTH PUB NONE NONE 1
0169616 05/09/2001 MS 0.5 0 .5 M 05/02/2001 The pt was taken to health services on 4/26/01 at 8:00 am. The pt was unresponsive, not breathing, blood at nose. ACL protocol started immediately. No rhythm or pulse. Code stopped. Autopsy report states cause of death: changes suggestive of vaccine related death, however, rollover cannot be excluded and would have to be excluded by scene investigation; findings are not consistent with SIDS. Y 04/26/2001 N 04/25/2001 04/26/2001 1 PUB PUB UNK NONE NONE MS01015 1
0169619 05/09/2001 GA 40.0 40 F 05/02/2001 On 10/2/00, I had an appt. with my PCP and I was dx'd with acute bronchitis and prescribed Zithromax but after taking this, I still was no better. I saw my PCP again on 10/10/00 and she prescribed Cefzil and administered a flu shot. I told her that I thought a flu shot was not to be given if a pt is sick. She replied that it was ok since I was not running a high-grade fever. I did tell her that I had been feverish prior to this visit. I then told her that I had heard of cases in which a pt received a flu shot and then got the flu. To this, she replied, "Well, you're sick anyway, so why does is matter?" During this time, I was being treated for Insulin Resistance with Glucophage and Amenorrhea with Loestrin Fe. Three days, post vax, I awoke in the middle of the night, with excruciating pain in my left arm, between my shoulder and elbow. The pain lasted a few days but then started in my right arm, in the same location. Days later, I awoke, late at night, with my hands throbbing and swollen. My doctor prescribed Vioxx, Relafen and Darvocet for pain; with no relief. She admitted that the flu shot could have caused my symptoms. She then referred me to a Rheumatologist. After testing, this doctor was leaning toward a dx of rheumatoid arthritis. I saw 2 Allergists, as well as my Endocrinologist and all 3 doctors told me NEVER to take another flu shot. One of the allergists also dx'd me with "Poisoning by antibiotic." My Endocrinologist dx'd my problem as serum sickness. I now take Plaquenil, Celebrex and prednisone. My Rheumatologist has found WBC in my right knee. One physician feels that my lymphatic system has been attacked as a result of the flu shot. In addition, I have had a flare of gout. It has been one thing after another. The 60 day follow-up report the pt states sed rate continues to be high, last reading was 45. Sed rate is coming down; however, she now has a new internist and rheumatologist; both concurr that she is experiencing an autoimmune reaction to the flu shot as the timing between the flu shot and the onset of my symptoms is too suspicious and cannot nor should not be ignored. The pain in her upper arms was studied via x-rays and MRI's. She is currently recovering from shoulder surgery; she will see her orthopedic surgen for follow up on 07/30/2001. Insulin resistence. The patient is a 41 year old white female former patient of MD. with a history of insulin resistence, hypertension, obesity and amenorrhea. The patient was initially seen because of weight gain. She was worked up, had thyroid function test, 24-hour urine for cortisol. These were apparently remarkable. She also had an insulin level which was elevated and subsequently she diagnosed as having insulin resistance. The patient returns to the clinic today and reports she is being evaluated by an immunologist because of some joint pain which started several months ago. The patient tells me that her father had diabetes mellitus. Her paternal grandfather and her paternal uncles also have diabetes mellitus. There is no history of dyslipidemia. The patient does have obesity. However she says she is not dieting and has a poor appetite for the past 4 months. She says with diet she was able to lose about 100 pounds. She currently weights 232 pounds and she is 5'8" tall. She is also on Glucophage 850mg t.i.d. The patient does report a history of (white coat hypertension). She also reports that she has irregular periods for about 6 to 9 months now. She says she is on birth control pills for about 15 years. However she was out on birth control pills because of amenorrhea rather than contraception. She says she now has very light periods (2 days only). The patient denies any galacturia, denies any dark pigmentation of the skin. She denies any headaches, denies any focal motor or sensory deficits, denies any peripheral vision cup, diplopia or blurred vision. Otherwise no complaints. Y Y N 10/10/2000 10/13/2000 3 Arthritis panel; lupus test-neg; Sed rate-high; RF-high; CRP-high; nuclear bone scan-no sign of inflammatory arthritis. Per doc 214444, patient states: "I continued to be treated for osteoarthritis and rheumatoid arthritis. My internist refers to me as the '"medical mystery"'. I have now been referred to another physician, a rheumatologist/Immunologist, several physicians. The flu shot is the investigator in this situation, the shot and the onset of my symptoms cannot be ignored. I have undergone surgery on my right rotator cuff and will undergo surgery on both knees this summer. Blood tests which tend to trend together are not doing so, thus, the mystery remains. Hopefully, the new physician I am scheduled to see on 06/03/2002 will have some answers. Interestingly, 2 others individuals in my hometown began experiencing the same symptoms I am. All 3 of us had flu shots around the same time at onset of symptoms closely following the vaccine. Neither has reported this to VAERS due to their physicians discouraging them to do so. I feel my situation is not uncommon but severely under-reported. A follow up report received 7/6/2001 adds that final diagnosis is rheumatoid arthritis, not Guillain-Barre syndrome. Follow up: patient still on predisone, celebrex, prednisone, activity limited-limps, can't bend knees-chronic fatigue. PVT PVT Zithromax, Cefzil, Glucophage, Loestrin Fe, Plaquenil 200 mg, Naprosyn 500 mg, Lasix, potassium, Ultram, Paxil, Acute Bronchitis Insulin Resistant, Amenorrhea, drug allergies. Allergies: Cephalosporine, Mepergan, Lorcet and Indocin, Mipregan, loreet plus, coflasporin antibiotics, cheddar cheese, peanuts, corn, wheat, mold, fungus 1
0169621 05/09/2001 NJ 1.5 1 .5 F 03/05/2001 Within 24 hours of Prevnar vaccine, this infant got a fever of 102 - 103 F, and hives all over her body. Y 02/09/2001 02/09/2001 0 OTH OTH Asthma Asthma, ear infection on 02/20/01. NJ200111 1
0169622 05/09/2001 TN 0.4 0 .4 F 04/09/2001 a mother states her child got her shots on 04/06/01, Hep B #2, Hib #2, IPV #2, and Prevnar #2. At approximately 2 - 3 PM the infant had an elevated fever of 103, relieved with Tylenol and lasted 3 days, appetite decrease, and diarrhea and rash generalized all over her body on 04/07/01. reported here today for care. Y 04/06/2001 04/06/2001 0 PUB OTH TN01014 1
0169623 05/09/2001 TN 0.2 0 .1 F 04/19/2001 This infant received shots on 04/12/01. She had a fever of 102.7 2 - 3 days fluctuating degrees, with Tylenol. A rash was noted (hives) "all over her entire body". She received children's Benadryl on 04/14/10 through 04/15/01. The hives started to disappear on Sunday and the hives were completely gone by Monday 04/16/01. The infant is to see a doctor today in the AM on 04/19/01. No problems noted instructed per doctor to inform us of a reaction. The mother was instructed to have doctor write orders for DT next time. Y Y 04/12/2001 04/12/2001 0 PUB PUB Mother (+) syphillis. Prophylactically antibiotics 10 days after birth. TN01015 1
0169624 05/09/2001 TN 0.6 0 .6 M 04/23/2001 This infant received vaccines (listed below) on 04/18/01. Later that evening, he had a fever of 104 and possibly higher. He was taken to the ER after 12 midnight. The mother also noted " bumps on his chest". He was treated with Motrin and Tylenol in the ER and discharged at 4 AM. No explanation. On 4/23/01 the mom states the following day she noticed the infant making "jerking" movements. Denies fever or rash at this time. She states the jerking has continued since then. Instructed at this time to notify the child's pediatrician, explain to nursing personnel and ask for an appointment today. Will follow up in the AM. On 04/24/01, spoke with the mother today, she states the child saw a doctor on 04/23/01. She states that the baby is "fine". No problems noted on examination. The doctor stated some jerking movements are common after going to sleep. None noted excessively. Y U 04/18/2001 04/18/2001 0 PUB UNK TN01017 1
0169625 05/09/2001 DE 55.0 M 05/04/2001 The pt is an orthopedic surgeon. He was reportedly "healthy". "Tests performed before and during the study showed no signs that the participants had Lyme disease." The pt received 2 doses of Lymerix on unspecified dates. Within 24 hours of the 2nd injection, he developed "severe swelling, redness and pain in his fingers". He also developed "acute disabling small and large joint symmetrical synovitis". A dx of "arthritis in his hands" was made. He also experienced flu-like symptoms, achiness, swelling in his toes, myalgia, and "severe pain in his shoulders." He was treated with "moderate doses of NSAIDS (NOS)" and recovered without sequelae, within 4 or 5 days. The guest physician stated, "And we have no reason to believe that it was anything but the vaccine involved in the development of the arthritis." He further stated, "We believe that the immune response to OspA is resulting in an auto reactive response." Y Y 05/16/1999 Test for Lyme disease-neg OTH OTH 20010107841 1
0169626 05/09/2001 DE 43.0 M 05/04/2001 The pt is a Pulmonologist. He was reportedly "healthy". "Test performed before and during the study showed no signs that the participants hand Lyme disease". The pt received 2 doses of Lymerix on unspecified dates. Within 24 hours of 2nd dose, he developed "severe swelling, redness and pain in his fingers". He also developed "acute disabling small and large joint symmetrical synovitis". A dx of "arthritis in his hands" was made. He also experienced "pain throughout his body" and myalgia. He was unable to work for 3 days. He was treated with "moderate doses of NSAIDS (NOS)". However, the abstract indicated that he recovered without sequelae within 4 or 5 days. The guest physician stated, "And we have no reason to believe that it was anything but the vaccine involved in the development of the arthritis." He further stated, "We believe that the immune response to OspA is resulting in an auto reactive response." F/U acute symetrical polyarthritis, additional information was provided by the primary author. The pt rec'd his 1st SC injection of LYMerix (lot LY120B9)on 9/2/99, no adverse experiences occurred following this injection. He rec'd his 2nd SC injection of LYMErix (lot LY123B9) on 10/1/99, he experienced pain throughout his body. Two days post vaccine on 10/2/99 he developed severe swelling. A dx of acute symmetrical polyarthritis was made. The primary author reported that the polyarthritis resolved after 5 days. Acute symmetrical polyarthritis does not meet icm serious criteria. Y Y 09/30/1999 10/02/1999 2 Tests for Lyme disease-neg PUB PUB NONE 20010107861 1
0169627 05/09/2001 PA 6.0 1 .0 M 05/13/2001 This patient's mother stated her child started breaking out with chicken pox on 04/28/01. He had six in total pox, itchy. PPD is all that was listed. Y 05/16/1996 04/28/2001 1808 NONE PVT PVT PPD, Connaught, lot # K11684. NONE NONE 1
0169628 05/09/2001 AL 38.0 F 04/03/2001 This patient had swelling. U 03/15/2001 03/15/2001 0 UNK UNK Dirty wound 1
0169629 05/09/2001 AL 66.0 M 04/03/2001 This patient had a rash. U 06/20/2000 06/23/2000 3 UNK UNK Acetaminophen (Tylenol) tabs, Ibuprofen (Motrin) tab, Insulin 70/30 (Novolin 70/30), Metformin (Glucophage), Bactrim, Diphenhydramine (Benadryl), Prednisone (Meticorten), Pneumococcal vaccine. 1
0169630 05/09/2001 DE 4.0 1 .0 F 04/30/2001 This child had Varicella in mouth and on body. No vaccine listed . States vaccine was given at another facility. Y 04/03/1998 02/04/2001 1038 NONE PVT UNK NONE UNK NONE 1
0169631 05/09/2001 MI 4.0 1 .0 M 04/30/2001 This patient received Varivax 10/21/97; he has recently been around a cousin with clinical varicella, a sibling (also previously vaccinated) developed varicella 2 weeks ago and today this patient has clinical symptoms of varicella. Y U 10/21/1997 04/30/2001 1287 PUB UNK 1
0169632 05/09/2001 MI 39.0 39 M 04/27/2001 Had TD after having laceration sutured on 4/8/01 in ER. Had anorexia, fatigue, felt feverish the next day. Two days later, had a fever of 104.3F. Continued to have fevers especially in the evenings, headache, myalgia, anorexia and 15 lb weight loss for 2 1/2 weeks. No specific symptom of viral syndrome. Recovering U 04/08/2001 04/09/2001 1 Sodium 133 low; Chloride 96 low; Sed Rate 34 high; Epstein-Barr antibodies-positive for Anti-VCA-IgG and IgM suggests past infection. In most populations, at least 90% of the adult population will have been infected with EBV sometime in the past and therefore, will be positive for antiVCA/IgG and anti-EBNA. Antibodies to EBNA develope 6-8 weeks after primary infection and remain present for life. Presence of VCA/IgM antibodies indicates recent primary infection with EBV. PUB PVT NONE NONE NONE 1
0169633 05/09/2001 IN 6.0 5 F 04/27/2001 States see attached sheet, but "attached sheet" not available. U 04/25/2001 04/26/2001 1 PVT PUB 1
0169634 05/09/2001 IN 0.3 0 .2 F 05/02/2001 Child seen on 2/28/01 for well child 2 month exam. Received DTAP, HIB, Prevnar and HEP-B. Child seen on 4/12/01 for "fussy and stiff with decreased smile X 2 weeks". Child hospitalized. (+) RSV (bronchiolitis) on 2/16/01, treated with Augmentin. After exam, it was revealed spasticity and abnormal eye movements. She was seen by neurosurgery, neurology, development and genetics. The present concensus is that pt may have a metabolic disease. Parents state child is waking up more at night and screaming. Child was put on apnea monitor for swallowing disorder. Shows signs of cerebral palsy/eye movement disorder. Has persistent URI. He was also found to have bilateral otitis media and treated with Amoxil. Annual report dated 05/02/2003: Diag death 2 hours to genetic mitochondrial Dz. Date of death: 10/03/2001. U 02/28/2001 04/12/2001 43 CT-abn with poor gray/white differentiation; MRI-showed decreased white matter likely secondary to diffuse cerebral edema. Etiology unclear but subcortical microscopic hemorrhage might be considered. PVT PVT Augmentin NONE RSV (bronchiolitis) on 2/16/01. 1
0169635 05/09/2001 KY 16.0 16 M 04/27/2001 Injection site was red, warm, tender and swollen. Pt was fatigued. Symptoms started 24 hours, post vax and resolved with Zyrtec 10mg, once a day. Y Y 04/17/2001 04/18/2001 1 PVT PVT NONE NONE NONE 1
0169636 05/09/2001 GA 34.0 34 M 01/05/2001 Had immunizations on 1/2/01 and noticed swelling of lymph nodes under left arm on 1/4/01 and tenderness under left arm although enlarged nodes were not painful. States no increase in lump or other symptoms. Referred to MD. Y U 01/02/2001 01/04/2001 2 PUB PUB NONE Sinus drainage NONE GA01029 1
0169637 05/09/2001 TX 4.0 4 F 05/07/2001 4cm reddened area with swelling on left leg. Y Y 05/02/2001 05/03/2001 1 PVT PVT Benadryl 1
0169638 05/09/2001 MO 1.0 1 .0 F 05/07/2001 Ataxia Y Y 04/17/2001 04/18/2001 1 NONE PVT PUB Fluoride ghs NONE NONE 1
0169639 05/09/2001 MA 40.0 40 F 05/08/2001 Left upper arm swelling, pain and redness. U 04/25/2001 04/27/2001 2 PVT UNK NONE Allergies 1
0169640 05/09/2001 KY 10.0 10 M 05/07/2001 Child was at school. Mother reports child broke out in hives especially on trunk and also had hives in groin areas and a few on arms and face. He had diarrhea several times. Mother took child to doctor and he gave him a steroid shot and sent him home on Benadryl and prednisone. Reports improved within 15 minutes after injection. Pt had a reaction at his Hep-B #2. He is to receive no more Hep-B vaccinations per his PMD. Y Y 05/03/2001 05/04/2001 1 PUB PUB NONE NONE NONE KY2001030 1
0169641 05/09/2001 TN 59.0 59 F 04/23/2001 Pt called on 4/20/01 at 10:30 and stated her right arm was red and blotched and complaining of mild difficulty breathing. She was told to see MD. She stated she was going to MD and was to call clinic with results. Also, given another telephone # to call. Tried to call pt on 10/23/01 and only answering machine picked up, so left a message for her to call clinic. U 04/16/2001 04/20/2001 4 PUB PUB OTC sinus meds; Meds for HTN; Meds for Lupus Lupus; Sinus infection (3 weeks ago); HTN TN01016 1
0169642 05/09/2001 CA 1.5 1 .5 M 05/04/2001 The pt experienced a red, edematous, macular rash at the injection site. (left proximal thigh) with pain and mile warmth with palpation. N 05/02/2001 05/03/2001 1 PVT PVT Tylenol, Motrin NONE NONE 1
0169714 05/09/2001 PA 20.0 20 F 02/02/2000 Subsequent to receiving vax the pt developed muscle aches, joint pain and fatigue. Additional information received reports that the pt recovered from this experience on 12/20/1999. Y 12/07/1999 12/07/1999 0 NONE OTH OTH history of sinusitis U1999010380 1
0169715 05/09/2001 NY 56.0 56 M 12/29/1999 Subsequent to receiving vax, the pt complained of redness from injection site to elbow. U 12/13/1999 UNK UNK U1999011110 1
0169717 05/09/2001 IN 19.0 19 F 01/14/2000 Subsequent to receiving vax, the pt developed a mild local reaction which consisted of localized erythema. U 01/03/2000 01/05/2000 2 NONE PVT PVT NONE NONE U2000000160 1
0169718 05/09/2001 LA 21.0 21 F 02/08/2000 It was reported that a 21 year old female pt received a Menomune A/C/Y/W-135 and a Fluzone SV '99-'00 vaccination on 11/11/99. Reportedly, on 11/12/99, the pt complained of night sweats, dizziness and nausea that lasted 1 day. The pt reportedly, recovered from this experience. Y 11/11/1999 11/12/1999 1 PUB PVT NONE Asthma U2000000260 1
0169719 05/09/2001 PA 20.0 20 F 02/08/2000 It was reported that a 20 year old female pt received a Menomune A/C/Y/W-135 vaccination on 11/30/99. Reportedly, the pt was running a fever initially after the vaccination. Approx. 1 week, post vax, on 12/6/99, the pt developed a hard-reddened area of her left upper arm about the size of an orange. Reportedly, the pt recovered from this experience. Y 11/30/1999 12/06/1999 6 PUB PVT NONE NONE U2000000270 1
0169720 05/09/2001 DC 18.0 18 F 06/19/2002 It was reported that an 18 year old female received a Menomune A/C/Y/W-135 vaccination on 10/3/99. Reportedly, 4 hours, post vax, the pt developed vertigo, nausea, tingling in her arm, malaise, fever and her arm became swollen with a red rash. The pt was given Benadryl and Tylenol as treatment. The pt reportedly, recovered from the experience. *F/UP report on 3/4/03: From correspondence received at manufactorer on 2/22/00, add'l PT history info was provided. F/UP #1 (6/19/02): During internal auditing of all files, it was deemed necessary to amend the report by updating the Adverse Event Coding (Added Fever and Paresthesia). Y 10/03/1999 10/03/1999 0 N/A UNK UNK NONE Allergic to certain detergents U200000032 1
0169721 05/09/2001 MA 19.0 19 M 02/29/2000 It was reported that a 19 year old male received a Menomune A/C/y/W-135 vaccination on 1/25/00. Reportedly, on 1/27/00, the pt developed a headache and a fever. The pt took Tylenol and was effective. The pt was not evaluated by a physician. From additional correspondence, it was reported that the pt was evaluated by a nurse practitioner. "No other symptoms consistent with 'flu', i.e.: 'aches', sore throat, cough, etc." U 01/25/2000 01/27/2000 2 OTH UNK Albuterol NONE History of Gilbert Syndrome U2000000670 1
0169722 05/09/2001 TN 18.0 18 F 03/17/2000 It was reported that an 18 year old female received a Menomune A/C/Y/W-135 vaccination on 2/8/00. Reportedly, the pt experienced a vasovagal reaction, post vax. BP-120/60, P-52, R-16. Resolution of symptoms after elevation of legs, ammonia ampule inhalant and ingestion of orange juice. The pt completely recovered from this experience. Y 02/08/2000 02/08/2000 0 OTH OTH NONE Codeine allergy U2000001010 1
0169723 05/09/2001 NC 20.0 20 F 03/16/2000 It was reported that a 20 year old female received a MENOMUNE vaccination on 2/15/00. Reportedly, post vax, the pt developed erythema, urticaria and itching. Pt denies dyspnea. Treatment of 50mg BENADRYL was given at 13:15. The pt reportedly, recovered from this experience. Y 02/15/2000 02/15/2000 0 BP-128/70; P-80; R-20; Afebrile OTH OTH Allegra, Proventil, Duravent, Ortho Tricyclin U2000001020 1
0169724 05/09/2001 NJ 18.0 18 F 04/12/2000 It was reported that an 18 year old female pt received a Menomune A/C/Y/W-135 vaccination on 02/10/00 at 14:30 and felt fine and left the office. The pt returned at 18:00, complaining of general weakness, nausea, chest tightness, hives and itching. The pt did not experience shortness of breath, BP-left 140/84-100-20; right 150/84-100-20. Treatment of Benadryl 50mg per oral was given. At 18:30, the pt's BP was left 140/84-100-20, right 150/84-100-20. The pt reportedly recovered from this experience. From correspondence received, it was reported that the pt did not experience chest tightness, hives and itching as previously reported, however, did experience diaphoresis. Y 02/10/2000 02/10/2000 0 OTH PVT NONE NONE U2000001030 1
0169725 05/09/2001 PA 19.0 19 F 06/19/2002 It was reported that a 19 year old female pt received a Menomune A/C/Y/W-135 vaccination on 2/7/00 at 12:05. The pt did not eat since early in the morning. Approx. 12:20, the pt became pale, weak and nauseated, BP 60/42. The pt's feet were elevated and she was given juice and crackers. After a half an hour of rest, the pt's BP was 94/62. The pt reportedly, recovered from this experience. *F/UP report on 3/4/03: F/UP #1: During internal auditing of all files, it was necessary to amend the report by updating the adverse event coding (added pallor & hypotension). Y 02/07/2000 02/07/2000 0 N/A UNK UNK Sore throat and took antibiotics 4 days ago; no temp. U2000001040 1
0169726 05/09/2001 PA 25.0 25 M 05/18/2000 It was reported that a 25 year old male pt received a Menomune A/C/Y/W-135 vaccination on 2/7/00 at 12:00. Reportedly, at 12:10, the pt stated he felt lightheaded, fell forward and the left side of his face hit the floor. The pt experienced a brief loss of consciousness, ammonia inhalant was effective. The pt lost a left upper tooth, had an abrasion and swelling of left cheek, abrasion of chin on left side and a small amount of blood in mouth. The pt had no recall of passing out. The pt was awake, alert, oriented, BP 162/84-164-20, rechecked 10 minutes later and BP 156/86-150-20. "I feel okay", pt sitting in chair, was given juice and remained oriented. The pt was instructed to see family doctor. Reportedly, the pt recovered from this experience. On 5/17/00, an error was amended in the actual onset time of the adverse event. The correct time was 12:10, not 12:02, as previously reported. Y 02/07/2000 02/07/2000 0 OTH UNK NONE NONE U2000001050 1
0169730 05/09/2001 TN 18.0 18 M 05/03/2000 It was reported that a pt received a Menomune A/C/Y/W-135 vaccination and sometime, post vax, the pt developed a headache, fever and possible viral symptoms. Additional information is being requested. From correspondence received, it was reported on 3/25/00, the pt developed a fever (100F-101F), chills and pain in the head. Pt went to the ER at 19:30. A fever of 99F persisted until 3/29/00. The pt reportedly, recovered from this experience. Doctor dx'd idiosyncratic reaction to vaccine or an "exagena normal response" and nothing to be concerned about. Y Y 03/23/2000 03/25/2000 2 CBC and Chemistry panel-both normal. PVT PVT NONE NONE U2000002540 1
0169731 05/09/2001 CO 18.0 17 M 02/12/2003 It was reported that an 18 year old male pt was dx'd with an Asymptomatic Arachnoid Cyst, 6 years ago, discovered by chance after an accident. This cyst was smaller at the time and did not need any intervention. Reportedly, the pt received a Menomune A/C/Y/W-135 vaccination on 1/21/00 and several weeks later, the pt developed severe headaches, rating a 10 on a scale of 1 to 10. Neurologist saw pt and had a MRI done which showed the Arachnoid Cyst was enlarged. Vioxx and Biofeedback was tried, which seemed to help slightly but headaches have continued. A Neurosurgeon has suggested possible surgery. From correspondence *received at manufacturer on 5/1/00,* it was reported that the pt continues to be treated with a non-steroidal anti-inflammatory. As of 4/12/00, the pt's headaches have subsided. He is scheduled for a return visit in 6/00 to the Neurologist. *F/UP report on 3/4/03: Amendments in the narrative and add'l PT and responsible MD info was also provided. (also added adverse event coding Aggravation Rx).* Y U 01/21/2000 UNK UNK NONE Dx'd with an Arachnoid Cyst which was discovered after an accident 6 years ago. U200000255 1
0169732 05/09/2001 MN 22.0 22 F 05/15/2000 It was reported that a female pt received a Menomune A/C/Y/W-135 vaccination on 3/31/00. Reportedly, sometime after the vaccination, the pt developed stridor. Additional information is being requested. It was reported that the pt recovered from this experience. Y 03/31/2000 03/31/2000 0 PVT PVT NONE NONE U2000002730 1
0169733 05/09/2001 NJ 20.0 20 F 07/31/2000 It was reported that a 20 year old female received a Menomune A/C/Y/W-135, a Typhim VI and an IPOL vaccination on 4/19/00. Reportedly, about 4-5 hours, post vax, the pt developed red, swollen and itchy eyes. This resolved fully with antihistamine. No further information is anticipated for this report. The case is closed. Y 04/19/2000 04/19/2000 0 NONE OTH PVT NONE NONE U2000002980 1
0169734 05/09/2001 VA F 05/02/2000 It was reported that a female pt received a Menomune A/C/Y/W-135 vaccination on 4/20/00. Reportedly, on 4/24/00, the pt experienced a seizure. The pt is a known epileptic on Lamictal. Further information requested. U 04/20/2000 04/24/2000 4 UNK UNK Lamictal Pt is a known epileptic on Lamictal. U2000003000 1
0169735 05/09/2001 CT 18.0 18 F 01/10/2001 It was reported that an 18 year old female received a Menomune A/C/Y/W-135 vaccination on 6/12/00. Reportedly, on 6/13/00, the pt developed a headache, fever, general malaise and a mild local reaction. Recovery status unknown. Further information requested. From additional correspondence received on 7/12/00, it was reported that on 6/15/00, the pt was dx'd with mono. Reportedly, the pt recovered from this experience. No further information is expected, case is closed. Y 06/12/2000 06/13/2000 1 PVT UNK NONE NONE U2000004880 1
0169736 05/09/2001 TX U 10/18/2000 It was reported that a pt (1 of 2) received a Menomune A/C/Y/W-135, a TD adult, a Flu (unspecified) vaccination and a PPD Tubersol skin test during the time of 6/8/00 and 6/10/00 (exact date not specified). Reportedly, sometime after the vaccinations, the pt developed reactive arthritis. Further information requested. On 9/6/00, additional correspondence was received from the responsible physician, no additional information was provided. U 06/08/2000 UNK UNK PPD-Tubersol 5 TU/Aventis Pasteur LTD U2000004920 1
0169737 05/09/2001 TX U 10/18/2000 It was reported that a pt (2 of 2) received a Menomune A/C/Y/W-135, a TD Adult, a Flu (unspecified) vaccination and a PPD Tubersol skin test during the time of 6/8/00 and 6/10/00 (exact date not specified). Reportedly, sometime post vax, the pt developed reactive arthritis. Further information requested. On 9/6/00, additional correspondence was received from the responsible physician, no additional information was provided. U 06/08/2000 UNK UNK PPD-Tubersol 5 TU/Aventis Pasteur LTD U2000004930 1
0169738 05/09/2001 ME 18.0 M 01/10/2001 It was reported that an 18 year old male pt received a Menomune A/C/Y/W-135 vaccination and a PPD-Tubersol skin test on 6/27/00. Reportedly, on 6/28/00, the pt developed a temperature of 100F and dizziness. A physician did not evaluate the pt. Further information requested. From correspondence received on 8/8/00, it was reported that the pt recovered from this experience. No further information is expected, this case is closed. Y 06/27/2000 06/28/2000 1 PVT PVT PPD-Tubersol 5 TU/Aventis Pasteur LTD/251811 U2000005360 1
0169739 05/09/2001 MN 18.0 18 F 06/18/2002 It was reported that a female patient received a Menomune A/C/Y/W-135 vaccination on 07/07/00 at 2:00 PM. Reportedly 30 hours after the injection the patient became severely nauseated, pale and developed shaking and jerking of her arms and legs, eyes were open but rolling, no loss of bladder or colon. When the patient came to she could see but not hear, could sit up but couldn't move legs. The patient experienced muscle fatigue for the rest of the day. Patient recovered from this experience and was okay the following day. From additional correspondence received on 10/10/00, the county were the vaccine was administered was provided. No further info is expected, this case is closed. *F/UP report 3/4/03: ....It was deemed necessary to amend the report by updating the adverse event coding - added Pallor, Nystagmus, Paralysis.* Y 07/07/2000 07/08/2000 1 PVT PVT NONE NONE U200000581 1
0169740 05/09/2001 PA 18.0 M 07/31/2000 It was reported that an 18 year old male pt received a Menomune A/C/Y/W-135 vaccination on 6/2/00. Reportedly, on 6/13/00, the pt developed a possible sterile abscess, no specifics provided. Further information requested. U 06/02/2000 06/13/2000 11 UNK UNK U2000005850 1
0169741 05/09/2001 PA 18.0 F 06/17/2002 It was reported that an 18 year old female pt received a Menomune A/C/Y/W-135 vaccination on 7/29/00. Reportedly, on 8/1/00, the pt developed a sore throat, a temperature of 101F, nausea and general aches. The pt was evaluated by a physician and was dx'd with a viral illness and her symptoms per the Adverse Event report, were not related to the vaccine. From additional correspondence received on 10/4/00, it was reported, "As per our telephone conversation of 9/26/00, this form was never started. Once this individual had gone to her physician, it was determined that she had a viral infection, which had nothing to do with the vaccine. Upon talking with our director and pharmacist in charge, it was determined that this was not an event to be reported." This case is closed. *F/UP report on 3/4/03: Viral infection added as adverse event coding* Y U 07/29/2000 08/01/2000 3 UNK UNK U200000634 1
0169743 05/09/2001 CA 19.0 19 F 12/28/2001 It was reported that a female pt received a Menomune A/C/Y/W-135 vaccination on 8/1/00. Reportedly, within 24 hours, the pt developed a fever of 102F, headaches and neck pain. Further information requested. *F/UP report on 3/4/03: It was reported per the PT that the Sx's resolved after 1-2 days and the PT recovered. This case is closed.* Y 09/01/2000 09/01/2000 0 PVT PVT NONE NONE U200000722 1
0169744 05/09/2001 OH 18.0 18 F 12/27/2001 It was reported that a female pt (twin A) received a MENOMUNE vaccination on 8/30/00. Reportedly, sometime after the vaccination, the pt developed vomiting, headache, dizziness and muscle aches for 3 days. Further information requested. F/UP report on 3/4/03: From add'l info received on 1/22/01, add'l responsible MD, PT and Lab info were provided. Reportedly, there were no other medications, illnesses at time of vax or pre-existing conditions. No further info was provided. This case is closed. U 08/30/2000 NONE PVT PVT NONE NONE NONE U200000723 1
0169745 05/09/2001 OH 18.0 18 F 12/28/2001 It was reported that a female pt (twin b) received a MENOMUNE A/C/Y/W-135 vaccination on 8/30/00. Reportedly, sometime after the vaccination, the pt developed vomiting, headache, dizziness and muscle aches for 3 days. Further information requested. F/UP report on 3/4/03: From follow-up info received on 1/22/01, add'l PT, vax administrator, responsible MD, lab data, PT illness at time & medical history were provided. There were reportedly no other PT medications. There were no adverse events reported for previous vax's. This case is closed. U 08/30/2000 NONE PVT PVT NONE NONE NONE U200000724 1
0169746 05/09/2001 TN 18.0 18 F 11/07/2000 It was reported that an 18 year old female pt received a Menomune A/C/Y/W-135 vaccination on 5/26/00. Reportedly, the pt developed migraine headaches, 1 week, post vax. From additional information received on 1-DEC-2000, additional information for the Reporter, Vaccine Administrator and Responsible Physician were received. The patient's recovery status was reported as unknown. U 05/26/2000 06/02/2000 7 OTH PVT U2000008030 1
0169747 05/09/2001 PA 19.0 19 F 01/10/2001 It was reported that a female pt received a Menomune A/C/Y/W-135 vaccination on 9/29/00. Reportedly, on 9/30/00, the pt complained of severe headache, a temperature of 102F, nausea and vomiting and malaise. Further information requested. U 09/29/2000 09/30/2000 1 UNK UNK U2001000430 1
0169643 05/10/2001 MI 1.5 1 .6 F 04/30/2001 Heavy breathing and pulling at ears the night before carrying her to the ER, some cough. In the ED, T to 40.2 on the evening of 04/27/01. Normally uses 0.5 L prn O2 at home, in ED pulse ox 94% on R.A. coffee ground material from G-tube. Initially hemoccult neg, but later when rechecked was hemoccult positive. Initially tachycardia, became SVT after albuterol, developed diminished respiratory effort, cardiac arrest and death at 9:10 PM. Autopsy report states cause of death as medical complications of prematurity: dehydration, bronchopulmonary dysplasia and edema, s/p Nissen fundoplasty for esophageal reflux, gliosis and extensive neuronal necrosis of the brain (brain atrophy) , small subdural hemorrhage (manner of death - natural). Cause of death-medical complications of prematurity. Y 04/27/2001 Y N 04/25/2001 04/27/2001 2 T- 40.2 on admit to ED, HR - 190, Pulse Ox 94%, EKG with SVT. Hemoglobin-7; Hematocrit-22 and thought to have a GI bleed PVT PUB Pulmicort, Serevent, Aldectozide, Lasix, Zantac, NaCl, KCl, Prednisone taper; Albuterol; Aldactone, Prelone; home oxygen Chronic illness only, no acute. Bronchopulmonary dysplasia, severe prematurity, gastroesophageal reflux disease, reactive airway disease, retinopathy due to prematurity and possible right-sided heart failure, pulmonary stenosis; numerouse hospitalizations due to respiratory disease (last visit 4/25/01) 3 days prior to death 1
0169644 05/10/2001 OK 0.2 0 .2 M 04/26/2001 On 03/22/01, Thursday, this child was given his two month vaccines at around 3:45 PM, he immediately started screaming and had a small lump at the sites, (3 needles). He had a slight fever the next couple of days, below 101, went away with Motrin or Tylenol, alternated. By Monday he was unusually fussy and restless, even when held, on Tuesday his eyes were matted, but after washing them two times with warm cloth it never came back, that night around 4 PM he just started screaming like he was in horrible pain, for about 3 - 4 hours. Once he was finally asleep, he slept for 12 hours. On Wednesday morning, he seemed like he still didn't feel very good, so his I bathed and fed him. He didn't want to eat as much as usual that day, again around 4 or 5 PM he started screaming again just like the day before, on both days after he would finally stop screaming, his eyes looked glassy and he would get quiet, with a blank look on his face, for a few minutes and then he would pass out asleep. I thought he was exhausted from the screaming fits so we didn't think much about it, his eyes got matted again on Wednesday night, and he refused his 9 PM feeding, screaming until around 10 or 11. He finally took his cereal and bottle, and passed out in my lap. Again I thought from exhaustion. On Thursday morning, on my way out to go to work, at 4:40 AM, I told the baby's dad that if he was cranky still and his eyes were matted when he woke up to call the doctor for an appointment. At 10:35 AM, I came home from work and found him dead in his crib. Y 03/31/2001 Y Y 2 N 03/22/2001 03/26/2001 4 PVT UNK NONE NONE Fever and crankiness.~Hep B (no brand name)~2~0.00~In Patient|~Vaccine not specified (no brand name)~~5.00~In Sibling 1
0169645 05/10/2001 NY 1.0 1 .1 M 05/01/2001 Following vaccination, the pt had a high fever of 105.8, then experienced a seizure. He seized for 35 minutes. Received O2, Lorezepam, IV Rocephin. Transported and was hospitalized for 4 days. Information has been received from a pediatrician concenring a 12 month old healthy male with no previous history of febrile seizures and a Cefzil allergy. It was reported that the pt began posturing and was given a second dose of lorazepam and IV phoenobarbital. The pt was transported to another hospital's pediatric care unit for four days. During this time th ept had a neurological examination and a spinal tap with unspecified findings. Diagostic and lab tests were reported as CXR: negative; CT head: negative; throat c/s: negative; WBC: 6.0; Hbg: 12.3; Ne: 135; K: 4.2; Cl: 97; CO2: 18; hematocrit: 36.1; plt: 392K; bands: 4; seg: 31, BUN: 10; creatinine: 0.6; Ca: 9.2; U/A: normal. The pt was discharged with rectal diazepam prn, if needed. The pediatrician at a follow-up visit described the pt was "recovered and looks great," and told the mother that her child may have had a viral infection. It was also noted that the pt, and sibling, did not have any adverse events following prior vaccinations. Additional info is not expected. Y Y 4 Y 04/20/2001 04/22/2001 2 Chest x-ray - neg, CT head - Neg, Throat culture - neg. CBC: WBC 6.0, Hgb 12.3, Hct 36.1, Plt 292k, Na 135, Glu 194, and several other lab test. CXR: negative; CT head: negative; throat c/s: negative; WBC: 6.0; Hbg: 12.3; Ne: 135; K: 4.2; Cl: 97; CO2: 18; hematocrit: 36.1; plt: 392K; bands: 4; seg: 31, BUN: 10; creatinine: 0.6; Ca: 9.2; U/A: normal. PVT PVT NONE NONE allergy to Cefzil 1
0169647 05/10/2001 34.0 33 M 05/08/2001 This patient is reported to have multiple sclerosis, diplopia, bilateral internuclear ophthalmoplegia, right-sided paraesthesias, expressive aphasia, cognitive deficit, sensory deficit, spastic paraparesis, fatigue, and myalgia. Subject BIT010001, a 33 year old male, with no previous medical conditions, received the 6th dose of Anthrax vaccine (lot # FAV047) on 05/09/00. The patient was taking no concomitant medications at the time of the event. The patient had no previous reactions to the Anthrax vaccines. Approximately two weeks after the 6th Anthrax vaccine, the patient experienced flu-like symptoms with fatigue, and myalgia without fever, which completely resolved within 24 hours. In July 2000, the patient reported a 3 week history of intermittent diplopia. In early October 2000, he experienced right-sided paraesthesias. In early December 2000, he began having difficulty with finding his words. From 12/21/00 to 02/05/01, he had persistent sensory deficits with deteriorating motor function. As of March 2001, deficits have slightly improved, though the patient remains completely bedridden. The patient was treated with multiple courses of high doses of steroids, intravenous immunoglobulin, interferon beta 1-6, and mitoxantrone. The patient was hospitalized at WRAMC on 12/21/00 and remains hospitalized. Follow up received on 6/20/01 states the pt has died from multiple organ failure. He had been receiving high doses of immune-modulating drugs which suppressed his immune system. An autopsy will be performed and the results will be provided in a follow-up report when the information is available. Y 06/04/2001 Y N 05/09/2000 07/01/2000 53 July 2000- MRI of the brain: characteristic multiple periventricular hyperintense lesions on T2 - weighted images. Dec 2000 - Lumbar Puncture (3rd): positive for myelin basic protein and oligoclonal bands. Jan 2001 - Visual Evoked Potentials: poor quality study; no conduction delay noted. Jan 15, 2001 - MR Spect: increased choline peak concerning for acute MS vs Neoplasia. Jan 15, 2001 - MR Thallium: markedly increased frontal parietal uptake worrisome for aggressive malignancy. Jan 23, 2001 - Brain Biopsy: consistent with demyelinating process; special stains rule out secondary etiologies; cancer and infection ruled out. Follow-up info received 8/14/01: pathologic dx from autopsy report indicated a diffuse large B-cell lymphoma involving both cerebral hemispheres, both cerebellum and multiple levels of the brain stem. The autopsy also reveals hemorrhagic lesions in the brain. Sections from the left cerebral hemisphere reveal a necrotic mass composed predominantly of large, atypical lymphoid cells. Similar appearing perivascular lymphoid cells are also noted in the right basal frontal lobe and the cerebral hemispheric sections also confirm the presence of extravasated red blood cells within the subarachnoid space overlying the left middle frontal gyrus the associated hemorrhagic necrosis of the adjacent cortex and an intraparenohymal hemorrage within the right occipital lobe. Autopsy reveals diagnosis of diffuse large B-cell lymphoma, recent subarachnoid and intraparenchymal hemorrhage, and acute neuronal necrosis MIL MIL He had been receiving high doses of immune-modulating drugs NONE NONE BIT010001 1
0169648 05/10/2001 FL 1.5 1 .5 M 03/08/2001 This infant had a fever of 104.9 several hours after his Prevnar administration. No localizing symptoms of infection found. Admitted to the hospital for R/0 sepsis. Lethargic. In the Blood cultures, urine cultures, CSF fluid not suggestive of infection. IV Ceftriaxone given. Y 2 Y 12/18/2000 12/18/2000 0 BC, Urine Culture, Lumbar Puncture. PVT PVT NONE NONE NONE 1
0169649 05/10/2001 MI 1.2 1 .2 M 05/01/2001 20 - 30 minutes complex febrile seizure with signs of infection was noted 05/01/01. Hospitalization after extensive septic work-up and antibiotic administration. He also had a fever less than 102 at all times. Also diagnosed with hyperglygemia. Y Y Y 04/23/2001 05/01/2001 8 Negative WBC, CT Scan, LP, Blood Culture, Urine Culture. PVT PUB NONE NONE birth injury, Erbs Palsy 1
0169650 05/10/2001 ID 1.5 1 .5 F 04/30/2001 This infant had red blotches on her cheeks, swollen eyes (lids & around) red, (right cheek - quarter to nickel size) one blotch on right arm quarter size. Y Y 04/30/2001 04/30/2001 0 PVT MIL NONE NONE NONE 1
0169651 05/10/2001 PA 0.5 0 .5 M 05/03/2001 This infant had local erythema with some swelling, and a fever of 103 at home. Temperature in the office 97 AX. Y Y 04/10/2001 04/11/2001 1 NONE PVT PVT Floride NONE NONE 1
0169652 05/10/2001 WI 0.5 0 .5 F 05/01/2001 This infant ran a fever of 100.2 axillary, the evening after her immunizations and had a runny nose. 05/01, @ 16:45, temp 100.8 axillary. Y 04/30/2001 04/30/2001 0 NONE PVT UNK NONE NONE NONE Fever~Vaccine not specified (no brand name)~1st & 2nd~0.00~In Patient 1
0169653 05/10/2001 VA 3.0 3 M 05/09/2001 This child had a 10 cm x 8 cm local erythematous reaction around the site of the Prevnar injection. No treatment provided. Y 03/20/2001 03/21/2001 1 NONE PVT PVT NONE NONE NONE 1
0169654 05/10/2001 IL 2.0 2 .0 F This child had a red area around the injection site. U 04/24/2001 04/26/2001 2 NONE PVT PVT NONE NONE NONE 1
0169655 05/10/2001 WA 0.4 0 .4 M 04/26/2001 A 5 month old male infant with constant crying, irritability, no sleeping,with "body stiffening" noted by his mother. brought to the ER received Benadryl and Tylenol. Y Y 02/20/2001 02/20/2001 0 NONE PVT UNK NONE NONE NONE 1
0169656 05/10/2001 SC 1.25 1 .3 M 05/02/2001 This infant had rosey pink non pruritic rash appear after DTaP / Hib administration in his right thigh. The rash began to spread upward to the right groin and abdomen. He was started on Keflex and a short course of Prelone on 05/02/01. Y 04/16/2001 04/17/2001 1 NONE PVT PUB NONE NONE NONE SC0215 1
0169657 05/10/2001 OH 1.5 1 .4 F 05/02/2001 On 05/01/01, this patient's mother called. Complained of left leg being swollen and red. Per manual not usual side effect. Told to give Tylenol. On 05/02/01, the Grandmother called, the patient's leg was swollen down to the knee. Told to take the child to the family doctor. On 05/01, the ER PA stated it was a local reaction. The patient had a slight fever. The patient was given Keflex and Motrin. Y U 04/30/2001 05/01/2001 1 OTH OTH NONE 1
0169658 05/10/2001 MI 1.25 1 .1 F 05/03/2001 Prevnar # 2 dose, 1 Week of Irritability, crying, 3 weeks of poor gait with noted leg dose administered in; collapsing not supporting full weight (4 other immunizations given on the same day? Which given in the same leg). Prevnar dose # 3, 3 day history of gait control leg collapsing under fall at Nml gait and 3 days post immunization. Y 02/07/2001 02/07/2001 0 NONE PUB PVT NONE NONE NONE 1
0169659 05/10/2001 TX 0.5 0 .5 F 05/02/2001 No data entered. Y Y 05/01/2001 05/01/2001 0 PVT PVT NONE NONE 1
0169660 05/10/2001 MI 0.8 M 04/30/2001 This infant had an induration on the right leg approximately 6 cm by 5 cm for 3 days, and a fever of 104 for 1 day. Y 04/10/2001 04/19/2001 9 PVT PVT NONE NONE 1
0169662 05/10/2001 IL 1.0 1 .8 F 05/03/2001 This infant had a fever, difficulty breathing, non0responsive body jumping, convulsion, wheezing. Treatment - ER room, medical follow up. Y U 04/19/2001 04/20/2001 1 PUB PUB NONE Febrile convulsion. 1
0169663 05/10/2001 VA 1.08 1 .1 M 05/02/2001 On 04/17/01, MMR given, HIB and PNE-CON. On 04/25/01, approximately 4 PM, the grandmother brought the infant into the clinic with what she called a rash. He had a fever of 101 (A) for the past 2 days and the infant was very whiney. The grandmother stated his skin looked funny for the past couple of days. The nurse stated to the doctor the skin appeared mottled, no rash felt or seen. The doctor who saw the infant 2 hours after LCHD stated he saw subtle erythematous papules on his back. the grandmother also stated the baby had loose stools on 04/24/01. The physician was not sure of reaction being viral or immunization related. Y Y 04/17/2001 04/24/2001 7 NONE PUB PUB NONE NONE NONE VA01011 1
0169664 05/10/2001 NJ M 04/23/2001 This patient received three vaccinations of Lymerix (Lyme) between 1999 and 2000. At the end of 1999 developed shoulder and neck pains. Diagnosed with osteoarthritis? N 03/25/1999 12/21/1999 271 Cervical x-rays, and MRI in June PVT OTH NONE Acute MI 1
0169665 05/10/2001 NY 80.0 79 F 05/01/2001 This patient had pain in the area where her shots were administered. Saw own MD - x-rays (2 times). Orthopedic, Cortisone shot - physical therapy. Y N 04/21/2000 04/25/2000 4 x-ray 2 different times at the hospital. PUB OTH NONE NONE 1
0169666 05/10/2001 NY 59.0 59 F 01/19/2001 On 01/04/01, this patient became light headed and nauseated 24 hours after receiving Influenza vaccine. It lasted for several hours. Called PCP, and went to the Health Dept, was told to go to PCP or walk-in. The patient felt better and did not go, called PCP and made an appointment for 01/10/01. On 01/10/01, the patient was seen by PCP, he told her it sounded like a reaction, she is fine now. Y 01/03/2001 01/04/2001 1 NONE PUB UNK NONE High blood pressure. NYS21010 1
0169667 05/10/2001 NJ 53.0 53 F 05/02/2001 Employee reported onset of asthma within 2 days of the flu shot (2000), fever of 101, and it (asthma) has occurred 3 times since then. Treatment with private physician. Y Y 10/23/2000 10/25/2000 2 PVT PVT NONE NONE 1
0169668 05/10/2001 CA 25.0 25 M 05/03/2001 This patient had swollen axillary lymph nodes of the right arm, headache, malaise, diaphoresis, and fevers. Y 04/27/2001 04/28/2001 1 NONE PVT PVT NONE NONE 1
0169669 05/10/2001 NY 39.0 31 M 01/16/2001 On 1/11/01, pt ran a temperature of 101F, shivering, sweating and dizziness. On 1/14/01, other symptoms decreasing except dizziness. That AM had stomach cramps but no nausea, vomiting or diarrhea noted. On 1/16/01, cramps and dizziness remain but have decreased. Referred to pt's MD. Pt feels no need, as symptoms are resolving. I stated for pt to call if he decides on MD follow-up. Y 01/09/2001 01/11/2001 2 NONE PUB PUB NONE NONE NONE NY21008 1
0169670 05/10/2001 NY 5.0 0 .6 F 11/13/2000 This patient received IPV #2, DTaP (Infanrix) #2, and Hib / Hep (Comvax) #2. The father relates elevated temp of 104 for 5 days to the doctor, blood work neg. Advised Motrin on 11/09/00. The patient has a "rash" on her trunk. reported to us on 11/08/00. Y Y 10/25/2000 10/26/2000 1 Father states blood work Neg. PUB UNK Father states Motrin for the elev temp. UNK UNK NYS21009 1
0169672 05/10/2001 MD 8.0 8 M 05/04/2001 Day after vaccine, had syncope, dizziness and headache. Y 05/03/2001 05/04/2001 1 PVT PVT PPD was also done on 5/3/01 NONE NONE 1
0169673 05/10/2001 IL 49.0 5 F 05/01/2001 This patient had a migraine headache. treated it with Imitrex, responded , but persisted for days. The migraine was with aura, blurred vision, resolved completely, brief. Right deltoid with erythema and induration / nodule formation, and tender; continues to improves. Generalized aches (arthralgias and myalgias) continue to improve. Y Y 04/20/2001 04/20/2001 0 04/23/01 BMP - Wnl, LFT - Wnl, ESR 16 mm/hr, CBC - Wnl, and CRP - Neg. PVT PVT Connective tissue disease, possible SLE, migraine headache disorder. 1
0169674 05/10/2001 IN 5.0 5 F 04/30/2001 Right upper leg, red and swollen with a circular area approx. 2 1/2" in diameter. Treated with Zithromax 200/5ml. N 04/04/2001 04/06/2001 2 PVT PVT NONE 1
0169675 05/10/2001 NJ 16.0 16 M 05/02/2001 Burning at injection site, immediately. Itching approx. 10 minutes later, nausea approx. 15 minutes, post vax. While on way home, he said he felt funny and his head leaned to the side, his eye rolled upwards, his face got red and he had difficulty moving, sweating profusely. Went back to doctor's office, BP was very low and he was put on oxygen. He was very pale, weak and dizzy. Went to hospital for observation. Y Y 04/11/2001 04/11/2001 0 EKG; Blood work; CXR; Neurological exam PVT OTH NONE NONE NONE 1
0169676 05/10/2001 TX 51.0 51 M 05/03/2001 Pt bit on inner left forearm on 4/26/01 at 22:30; seen by health dept; no adverse symptoms; vaccinated on 5/3/01. Y Y 05/03/2001 PUB PUB NONE Allergic to codeine; bitten on 4/26/01 1
0169677 05/10/2001 TX 12.0 12 F 04/30/2001 Within 24 hours, post vax, cried with pain from knee to toes and aching in joints. Has persisted for 3 days; so far unresponsive to Advil, Tylenol with codeine. No fever. No erythema or swelling at injection sites. Normal neurological exam; muscle strength and coordination. No abnormalties on PE or neurological. U 04/23/2001 04/24/2001 1 CBC; ESR; CK; Urine myogloblin PVT PVT NONE Allergy to Bactrim 1
0169678 05/10/2001 OH 14.0 14 M 04/26/2001 This patient had a fever of 102, dizziness, muscle aches. Treating symptoms with Motrin. U 04/25/2001 04/26/2001 1 NONE PVT PVT NONE NONE NONE 1
0169679 05/10/2001 NM 1.7 1 .7 F 05/03/2001 Seen in office on 5/2/01 at 15:00 with left upper arm at site of DTAP with 7cm X 6.5cm raised, red and warm area. No cellulitis. Discharged home with instructions to treat with Benadryl and cook packs. Y Y 04/30/2001 05/01/2001 1 NONE PVT PUB NONE NONE NONE 1
0169680 05/10/2001 GA 26.0 26 F Immediately, post vax, pt began feeling sick to her stomach and at the site of the injection there appeared an instantaneous red blotching of the skin. No raised areas, however, then after about 10 minutes, redness faded away. Y 04/20/2001 04/20/2001 0 PUB PUB CVS decongestant Congestion in sinuses 1
0169681 05/10/2001 MI 4.0 4 M 04/30/2001 Approx. 11:30 on 4/26/01, received shots and that evening had a 2" diameter with "bee sting look". By 4/27/01 AM, had redness and swelling to the elbow. He was given Tylenol. Child complained of bad arm. By 4/28/01 PM, redness and swelling to wrist. Child was taken to ER and given Benadryl (cortisone med given to mother to give to child but she held). Gave Benadryl every 6 hours. By 4/29/01, symptoms were gone. Mother did not take temperature. Y Y 04/26/2001 04/26/2001 0 PUB PUB NONE NONE NONE 1
0169682 05/10/2001 NY 29.0 29 F 05/02/2001 Arm started getting hot and burning, then had a fever of 104F. The next morning, had pain in jaw and lower back-tightening up. Loss of appetite X 2 days. The fever lasted from 4/24/01 to 4/25/01 and then went down to 102F and the next day, it was 100F. Y Y 04/24/2001 04/24/2001 0 CBC PVT PVT Birth control pills, Mercette NONE Hay fever; migraines 1
0169683 05/10/2001 HI 1.5 1 .5 F 04/30/2001 The afternoon of the day following vaccinations, pt noted to be crawling instead of walking, with a 2" area of erythema and about 10cm of swelling at the site of vaccination. 2 days, post vax, pt bearing weight but still limping. Today (3 days later, normal gait with only 2cm area of induration). Y U 04/27/2001 04/28/2001 1 NONE PVT PVT Dimetapp infant decongestant drops Acute Nasopharyngitis Obesity 1
0169684 05/10/2001 KY 35.0 33 M 05/02/2001 This patient had chest pain and discomfort, lots of frequent heartburn and acid reflux, an headaches. N 04/07/2000 06/01/2000 55 NONE OTH OTH Cut on forehead. Allergic to Penicillin. 1
0169685 05/10/2001 IL 4.0 4 F 05/03/2001 DTAP given on 4/26/01, noticed bluish purple area that PM. On 4/27/01, mom noticed small red circle at shot area. Pt seen on 4/28/01 with 5 1/2cm X 7 1/4cm blotchy rash on left anterior thigh with a bruise at superior border; firm but not tender. No systemic illnesses. Y 04/26/2001 04/26/2001 0 PVT PVT 1
0169686 05/10/2001 FL 30.0 30 F Pt states he had a little swelling, redness and tenderness to arm. Thought it was due to lifting weights but now believes it was related to the shot. Y 04/18/2001 04/26/2001 8 PVT PVT NONE NONE 1
0169687 05/10/2001 KS 5.0 5 M 05/02/2001 Approx. 10-15 minutes, post vax, pt was seated in lab waiting area. He then fell from the chair onto the floor, quickly recovered, was pale for a few minutes, then was normal. Parents say he collapsed onto the floor. Y 04/19/2001 04/19/2001 0 PVT PVT NONE Otitis Media NONE 1
0169688 05/10/2001 LA 14.0 14 M 05/01/2001 Discomfort in right deltoid, 24 hours later. Erythema on right deltoid, 4 days later, on 4/28/01. Erythema, induration and maculopapular rash with itching and discomfort on 4/30/01, 7 days later. Examined by doctor and order Motrin and Benadryl. On 5/1/01, mother reports arm is improving. Y Y 04/24/2001 04/28/2001 4 PUB PUB NONE NONE 1
0169689 05/10/2001 FL 12.0 12 F 04/23/2001 Skin rash papular pustular upper back and buttocks, right ear drainage and right face swelling noticed by mother, 4 days after MMR. Right ear drainage and right face swelling resolved. Skin rash persisted. N 04/17/2001 04/21/2001 4 NONE PUB UNK NONE NONE 1
0169690 05/10/2001 CO 5.0 5 F 05/03/2001 Cellulitis at location of vaccine 7cm X 5.5cm, erythema and swelling. U 05/01/2001 05/02/2001 1 PVT PVT NONE NONE 1
0169691 05/10/2001 IA 4.0 4 M 05/03/2001 Mother reports to PHN on 5/2/01 and states that child had "fever" (not checked) at 18:30 on 5/1/01 but at midnight, temperature was 104.5F (ax) and given Motrin but same temperature in the morning. Called MD and instructed to use Tylenol. At 13:00 on 5/2/01, temperature had decreased but "going back up". Child had "dry heaves" earlier in the morning with complaint of stomachache now, at 13:00. Child alert. No redness of arm. On 5/3/01, mother reports that fever "broke" on the evening of 5/2/01. No problems today. Y 05/01/2001 05/01/2001 0 NONE PUB PUB NONE NONE NONE 1
0169692 05/10/2001 NJ 1.7 1 .7 M 05/03/2001 Child received DTAP vaccine on 5/2/01 and began having fever of 103F (axillary) at 20:00, that night. Also began vomiting and having diarrhea. Vomited X 4 during the night and X 4 on 5/3/01. Had watery stools X 3 the night of 5/2/01 and X 4 on 5/3/01. Fever was 102F (axillary) on the morning of 5/3/01. Y U 05/02/2001 05/02/2001 0 PVT PUB NONE NONE 1
0169693 05/10/2001 CA 2.3 2 .4 M 05/04/2001 Large irregular ring (rash), swollen area at site. No induration. Y 05/01/2001 05/04/2001 3 NONE PVT PVT NONE NONE 1
0169694 05/10/2001 TX 58.0 58 F Approx. 26 hours, post vax, pt had nausea, diarrhea, abdominal cramping and low-grade fever began. Seen by MD on 4/26/01 at 13:00. Rx'd Pepto-Bismol and had gradual and steady improvement. Completely "better" by 4/30/01. Only site of injection complaint was redness. Y Y 04/24/2001 04/25/2001 1 NONE PUB PVT NONE NONE Allergies to PCN, Compazine TX0105 1
0169695 05/10/2001 NH 12.0 12 F 05/08/2001 Red, swollen and sore upper arm 2-3 hours, post vax. Seen here, 2 days later and was +4cm, flat erythematous area (increased warmth) in SC vaccine of LUE. No signs or symptoms of systemic reaction. Advised to use ice and Benadryl and to call if she has any other concerns. Y 04/02/2001 04/03/2001 1 PVT PUB NONE NONE NONE NH0113 1
0169696 05/10/2001 NM 79.0 79 F 05/01/2001 Pt called on 4/30/01 and reported upper arm swelling and redness at injection site within 24 hours, post vax. Also complained of itching all over body with rash within 48 hours, post vax. Then 24 hours of nausea and vomiting, diarrhea and body aches. Symptoms gone by 4/30/01. Y 04/25/2001 04/26/2001 1 NONE PVT PVT ASA NONE Breast Cancer; GERD; Fracture of left lower leg 1
0169711 05/10/2001 NH 4.0 4 F 05/08/2001 On 3/14/01, left deltoid 5cm X 5cm redness, itchy but not hard. Treated with Benadryl and ice 3 X 1 day. Y U 03/12/2001 03/14/2001 2 NONE PVT PVT Augmentin, Claritin 3/12/01-Otitis Media Recurrent Otitis Media NH0109 1
0169712 05/10/2001 MN 10.0 14 F 05/07/2001 Approx. 2 months, post vax, the injection site became red, swollen and hot. Approx. 2 days later, pt began experiencing substantial arthritic pain. This arthritic pain has shown no sign of abating in the approx. 3 weeks since its start. Further evaluation is being done by our family physician. Y U 08/21/2000 02/22/2001 185 Sed rate-high; Lyme disease-neg on 4/25/01 UNK UNK minocycline; Cephalexin for short time after initial reaction (4-17-01 to 4-20-01) Acne 1
0169697 05/11/2001 VA 1.0 0 .1 M 06/07/2000 Case reference number 1998004046-1 is a clinical trial report from study number 208355/117 (Tripedia at 2m and 4M) which is a single-blind study referring to a male aged four months. The patient's past medical history included cough and congestion. The following drugs are also known to have been taken by the patient prior to this event: OmniHib and Orimune on 09/24/97, Tylenol starting 09/24/97, and Dimetapp starting 09/24/97. The patient received his first dose of study vaccine (Tripedia) on 09/24/97, for Diphtheria-Tetanus-Pertussis Prophylaxis. A lump in the right groin was noted the morning of 10/09/97. The infant began treatment with Keflex. Upon recheck, with the physician on 10/10/97 the area was larger, slightly more red and his temperature was up to 101.3 rectal. Ultrasound indicated and inflammatory process. The infant underwent incision and drainage of the right inguinal / femoral lymph node abscess under general anesthesia and spinal block on 10/10/97. The infant was released, and at home his parents gave him a dose of 1-2 ml of Tylenol with Codeine for the pain at approximately 20:30 on 10/10/97. (At 21:30 he was given his 4th dose of Keflex). A few minutes after 21:30 the infant was noted to have his head turning to the right, pupils dilated and he began arching his back with stiffness of all extremities and was unresponsive to parents. The stiffness lasted approximately 1 1/2 hours, with symptoms resolving slowly during the last 30 minutes. He became responsive and started to feed. He was seen in an ER at 22:50. His eyes had become less dilated. The infant did not have a fever. The eventual diagnosis was dystonic reaction to Tylenol with Codeine. The most recent info received reports the event resolved. The investigator reported the dystonic reaction to Tylenol with Codeine not related to the treatment with the study vaccine., but related to Tylenol with Codeine. Y Y 09/24/1997 10/10/1997 16 10/10/1997 - Blood Urea Nitrogen 5 MG/DL, Carbon Dioxide 20 MEQ/L, Chloride 106 MEQ/L, Creatinine .3 MG/DL, Glucose 90 MG/DL, Potassium 6.5 MEQ/L, Sodium 138 MEQ/L. UNK UNK 09/24/97 Dimetapp, 10/11/97 General anesthesia, 10/11/97 Keflex, 09/24/97 & 12/05/97 OmniHib, 09/24/97 & 12/05/97 Orimune, 09/20/97 Pediacare and Spinal Block, 09/24/97 Tylenol, 10/11/97 Tylenol with Codeine. Congestion, Cough, Drain Lymph Nodes, Knot in Groin. 19980040461 1
0169698 05/11/2001 OH 0.2 0 .2 F 06/07/2000 Subject was enrolled in study 208355 / 117 and received her 1st dose of the study vaccine on 09/08/97. Twenty-on days post study medication, the subject was diagnosed with pneumococcal meningitis. She was hospitalized and treated with Ceftriaxone and Penicillin. Fourteen days after onset, the pneumococcal meningitis resolved and the subject was discharged. The investigator reported the pneumococcal meningitis was severe, serious, life-threatening and unrelated to study medication. Y Y 09/08/1997 09/29/1997 21 Cerebrospinal Fluid - WBC 350. Hematocrit - 26. White Blood Cell Count - 3.7. UNK UNK 19970247561 1
0169699 05/11/2001 U 06/07/2000 Case reference number 1998010461-1 is a clinical trial report from study number 208355/117, which is a single blind study, referring to a 7 month old female. At the time of the event, the subject had Mongolian spots, pale hands, and systolic murmur. Concomitant medications are unspecified. The subject received study vaccine on 10/01/97 and 02/03/98. For three days prior to dose 2, the child had mild upper respiratory illness symptoms (cough, rhinorrhea and fever). The child was afebrile at the time of vaccination. Two days after dose 2, the child developed raised red rash and vomiting x 1. the pediatrician felt the rash was related to a viral illness. the following day the child developed a fever (102.2), but no other symptoms. Four days after dose 2, the child developed 2 minute episodes of arm stiffening, unresponsiveness, and (abnormal) eye movements. Episode was thought to be either a seizure or normal behavior. the child had two more episodes the following day, and was hospitalized with a diagnosis of hypocalcemic seizure, RSV bronchiolitis, Rickets and vitamin D deficiency. She was treated with IV Calcium replacement and vitamin D, Albuterol inhalers, Calciferol, and Titrilac. The most recent info received reports the event resolved. The investigator reported the seizure, bronchiolitis and Rickets not related to treatment with study vaccine, but rather associated with vitamin deficiency RSV infection. Y Y 02/03/1998 02/07/1998 4 02/07/1998 - Calcium - 5 U, Phosphorus (Inorganic) - 3.6 U, RSV Culture : positive. UNK UNK Mongolian spots, pale hands, systolic murmur, 19980104611 1
0169705 05/11/2001 NJ 59.0 59 F 05/09/2001 Report 2001021398-1 described dehydration due to diarrhea in a 59 year old female who received Lyme disease vaccine OspA recombinant (Lymerix) for prophylaxis of Lyme disease. This report was received from the vaccinee and has not been verified by a physician or other health care professional. Reportedly, the vaccinee was allergic to IV pyelogram dye, dextropropoxyphene hydrochloride (Darvon), and "caines", chocolate and nuts. Reportedly, she had no medical history and took no concomitant medications. Reportedly, she was never diagnosed with Lyme disease. On 02/19/01, the vaccinee received her 1st left arm dose of Lymerix. Reportedly, 36 hours later, she developed diarrhea, which got progressively worse. On 03/05/2001, two weeks post-immunization, she was experiencing diarrhea which reportedly occurred six to eight times daily. Additionally, at this time, she reported that she developed flu-like symptoms, headaches, and muscle pain in the cervical area. The muscle pain in the cervical area would resolve, and the muscle pain would move to the thighs. Reportedly, she never experienced joint pain. She was treated with anti-diarrhea medications and a BRAT (bananas, rice, applesauce and toast) diet with no no results. An ultrasound of the abdomen was performed. The results were reportedly "normal". A gastroenterologist admitted the patient into the hospital on 03/20/01. Reportedly, inpatient testing consisted of stools for occult blood, thyroid levels and "other labs" (results unknown). CT of the abdomen was reportedly "normal". She was treated with IV antibiotics. The patient reported that a diagnosis of dehydration due to diarrhea was made. She was discharged from the hospital on 03/22/01. Her weight decreased from 126 lbs to 108 lbs in one month. She was scheduled to have a "H.D.D.A Scan (3) abdominal" on 05/07/01. As of 05/07/01, reportedly, her diarrhea persisted (she was having three to six bowel movements per day), she was fatigued, and she experienced muscle loss in her thighs and arms due to weight loss. The patient stated that she had been out of work since experiencing the above mentioned adverse events. Reportedly, her symptoms prevented her from working as a horticulturist. She stated that she has recently applied for disability and is considering applying for worker's compensation. F/U this report has been verified by a physician. F/U 3/19/01 (gastroenterologist visit): colonoscopy revealed evidence of hemorrhoid. No colon tumor or any mass lesion was seen at that time. For the past month, the pt had periods of diarrhea and severe abdominal pain. She had been treated with antibiotics (NOS), as well as, with lansoprazole (Prevacid) with no signigicant relief. The diarrhea persisted as of 3/19/01. She also complained of weight loss, recurrent moderate to severe abdominal pain in the epigastric area with early satiety. There was no dysphagia. She had no history of fever or chills and no history of rectal bleeding. Mild tenderness in the epigastric area was noted on physicial exam. Impression: persistent diarrhea could be related to inflammatory bowel disease or infectious enterocolitis or c. Diff. colitis. Plan: at this time will obtain stool for C diff., CBC with diff, CMP antigliadin, antiendomysial antibodies, colonoscopy exam. 3/29/01 (gastro visit): The pt had recently undergone colonscopy exam and no colitis or Crohn's ileitis was noted at that time. There was no evidence of malnutrition. However, the pt continued to lose weight and the abdominal pain had returned, in spite of symptomatic treatment. Workup for celiac disease was also essentially unremarkable, other than minimal increae in transglutaminase. In view of the above due to the pt to undergo upper GI (gasroentestinal) endoscopy. 4/24/01 (gastro visit): the physician stated that extensive workup had been unremarkable. The possibility of Whipple disease was suspected on biopsy and the physician was awaiting a second opinion. The pt also was in the process of obtaining MRI for pancreas and cyst in the L hypochondriac area. There was no history of hematemesis. Other than decreased weight, the physical exam was essentially unremarkable. Impression: possibility of rare infection, celiac disease, Whipple or other bacterial overgrowth are in the differential diagnosis. 5/1/01 (gastro visit) the pt was taking loparamide hydrochloride (Imodium), colestyramine (Questran), and antispasmodic medication (NOS). She was eating a gluten free diet and avoiding fat. Diarrhea seemed to be improving. Abdominal pain was somewhat decreased, since the previous visit, she was feeling somewhat better, MRI performed was reportedly unremarkable other than for cyst in the left lobe of the liver. The gastroenterologist had not yet rec'd the final small intestine biopsy report or the final MRI report. There was no istory of dysphagia. Recent blood work (NOS) revealed no evidence of nuritional deficiency or anemia. Symptomatic treatment was continued. As of 8/6/01, the outcome of the adverse events was unknown. F/U as of 8/28/01, the outcome of the adverse events was unknown. Y Y 3 N 02/19/2001 03/20/2001 29 03/20/01 - CT - Abdomen "Nml". Ultrasound - abdomen "Nml". Occult Blood (stools) - 0. Thyroid - 0. 3/19/01 colonoscopy - hemorrhoids. PVT PVT Allergic to caines, Darvon, IV pyelogram dye.F/U reportedly she had no medical history and rec'd conjugated estrogens (Premarin). Her surgical history include total abdominal hysterectomy, oophrectomy and appendectomy. 20010113981 1
0169707 05/11/2001 IL 0.3 0 .4 M 11/20/2001 A nurse practitioner reported that a 4 month old male received injections of Prevnar, Tripedia, IPV, and Comvax on 04/18/01. Within 24 hours of vaccination, the patient developed a generalized petechial rash and an injection site reaction described as "tenderness, redness, warmth, and swelling" at the Prevnar administration site. The reporter also noted that two other injection sites were red and inflamed. On 04/19/2001, the patient was "completely covered with purpura and petechia". He was hospitalized on 04/20/01, for three days with thrombocytopenia (platelet count not provided). the events were treated with immune globulin and the patient is "now doing fine". The follow up info was received on 05/23/2001 that indicated that the pt had no preexisting illness at the time of vaccination and he received no vaccinations within 4 weeks of 04/18/2001. Follow-up info indicated that the child was seeing another primary care physician and that the reporter in this case had no follow up with the pt since the thrombocytopenia. The physician felt that the thrombocytopenia ha dstarted prior to the vaccination on 04/18/20001. In addition, the pt had no adverse events after the first dose of haemophilus B comjugate vaccine hepatitis b vaccine recombinant, administered at 2 months of age. It was also reported that the child "was expected to make a full recovery." this report was originally reported by a nurse practitioner. Follow-up info indicated that the pt's platelet count was 2000. Y Y 3 Y 04/18/2001 04/19/2001 1 04/20/2001 Platelet count decreased PUB PUB NONE Conjunctivitis WAES01060965 1
0169708 05/11/2001 OH 5.0 5 F 04/17/2001 This child received her immunizations at 11 AM on 02/14/01. By 1:30 PM, she had a fever of 101. It peaked at 103. The next morning she had a seizure. The mother took her to their family physician. She was admitted to the hospital and diagnosed with pneumonia. She was treated with IV antibiotics and discharged on 02/18/01. She had been seen on 02/12/01 at the ER for a dry cough. Discharged. Chest x-ray had been negative. The child is doing well at the present. Y Y Y 02/14/2001 02/14/2001 0 PUB UNK 2 Day history of dry cough. OH0025 1
0169709 05/11/2001 OH 0.6 0 .7 M 04/30/2001 Immunizations administered approximately 2:30 PM on 04/23/01. 3 hours later, the infant began running a fever of 103 - 104. Used both Tylenol and Motrin, and fever stayed elevated. The infant was seen by a doctor and admitted to the hospital for 24 hours after the spinal tap was normal, the doctor felt it was probably a virus. Fever Wednesday 04/24/01 101 - 102 but the infant was acting normal. Diagnosed with allergic reaction to pertussis vaccine. Y Y 1 Y 04/23/2001 04/23/2001 0 Spinal tap - Nml PUB PUB Tylenol and Motrin. NONE OH0020 1
0169710 05/11/2001 MI 1.25 1 .3 M 05/03/2001 One hour after injection this infant started vomiting 8 times in 1 hour, stopped after approximately 3 hours, no fever. Y Y 05/01/2001 05/01/2001 0 NONE PVT PVT NONE NONE NONE 1
0169749 05/11/2001 CA 3.0 3 M 04/25/2001 Redness and swelling of the left arm 3 x 4 circumference, and itching. Y U 04/25/2001 04/27/2001 2 NONE PUB PUB NONE Bronchiolitis, pneumonitis 05/17/99. History of asthma. CA010043 1
0169750 05/11/2001 KY 0.2 0 .2 F 05/07/2001 On the day of immunizations the infant had no problem. However, the next day the infant had 13 hours with no sleep followed by 10 minutes of sleep, then a seizure lasting less than 60 seconds. The infant was taken to the ER, a chest x-ray was done. Visited Ped. Upper GI done on 05/07/01 with normal results. Y N 05/02/2001 05/03/2001 1 chest x-ray. PUB PUB Diflucan. NONE NONE KY2001031 1
0169751 05/11/2001 SC 2.0 2 .1 F 05/10/2001 This patient had a temp of 101, 12 hours after injection of Prevnar at 2 years old. U 05/09/2001 05/09/2001 0 PVT PVT NONE 1
0169752 05/11/2001 CA 0.3 0 .3 F 05/05/2001 The pt experienced pallor, hypotension, unresponsiveness, petechiae to the lower extremities. Y N 05/03/2001 05/03/2001 0 O2 saturation 97% PVT PVT NONE NONE 1
0169753 05/11/2001 CA 4.0 4 F 04/20/2001 Mother reported redness and swelling to bilateral arms, deltoid areas (8 hours after immunizations). The child was afebrile, skin was soft to touch, no drainage from sites, positive measurement taken, (+) gm check, (+) mvt of cxt. Recheck in 2 days. N 04/18/2001 04/18/2001 0 NONE PUB OTH PPD, Lot # 00540P, left arm, 04/18/01. NONE NONE 1
0169754 05/11/2001 OH 1.25 1 .3 M 05/08/2001 following vaccine the pt developed hives on torso and fever of 101. Y Y 05/04/2001 05/05/2001 1 PUB UNK NONE NONE 1
0169755 05/11/2001 MI 3.0 3 M 05/07/2001 The pt experienced a localized reaction that 12 cm area of redness, swelling, induration, tenderness and dark skin color. U 05/05/2001 05/05/2001 0 NONE PVT PVT NONE NONE 1
0169756 05/11/2001 IN 1.0 1 .0 F 05/07/2001 On 4/26/01 the pt experienced a maculo-papular erythema eruption over the extremities. Y 04/23/2001 04/26/2001 3 NONE PVT PUB NONE rhinorrhea / URI allergy to Zithromax and Amoxil 1
0169757 05/11/2001 OH 0.75 0 .7 F 04/30/2001 Information from mom. On 01/25/01, infant was fussy that evening, temp 99, Tylenol every 4 hours. On 01/26/01, Temp was 101 - 102 during the day, Tylenol every 4 hours, temp was 103 approximately 7 PM. On 01/27/01, 5 AM, taken to the hospital, temp 105.5 "rectal", fussy. crying, couldn't sleep; ER gave Tylenol. Y Y 01/05/2001 01/25/2001 20 NONE PUB PUB NONE NONE NONE OH0021 1
0169759 05/11/2001 MI 2.0 2 .1 F 04/24/2001 No data provided. Y U 04/23/2001 UNK UNK Amoxicillin 1
0169760 05/11/2001 NY 1.5 1 .5 F 05/01/2001 Mom states one day post vax, the child's arm swelled up and was sore. She applied cool compresses and gave Tylenol. This all went away the next day. On 4/13/01, the other arm had a blister almost like chicken pox. On 4/14/01, the pt's grandmother thought it looked infected but to wait until the pt saw the doctor. On 4/16/01 the pt saw a doctor and was placed on antibiotics. On 4/18/01 the pt went to the ER and was told by the ER MD it was a sterile pox, and no further treatment was needed. Y Y 04/03/2001 04/03/2001 0 PUB PUB NONE NONE NYS21013 1
0169761 05/11/2001 MA 46.0 45 F 05/10/2001 The pt experienced multiple joint and muscle pain of severe intensity that has been somewhat migratory, often bilateral accompanied by joint laxity and muscle weakness resulting in severe compromise of all ADL activities and functional mobility. Treated by rheumatologist with dilofenal and sylfasalazine Y N 04/06/2000 07/01/2000 86 elevated ESR, elevated C Reactive protein, serology revealed, decreased lymphocyte, HLA 627 neg, HLA-DR4 - positive PVT PVT NONE NONE NONE 1
0169762 05/11/2001 MA 49.0 47 M 05/05/2001 The pt experienced stiffness, swelling joints of legs, headaches, and weakness in legs. Y U 06/07/1999 01/20/2000 227 PVT UNK 1
0169763 05/11/2001 NY 52.0 50 F 05/10/2001 A couple of months following dose 3 of Lymerix, the pt experienced unspecified symptoms. She subsequently diagnosed herself with traveling arthritis. The pt stated that her primary care physician has not diagnosed her with "traveling arthritis. As of 5/2/01, the outcome of the event was ongoing. N 05/01/1999 07/01/1999 61 OTH OTH hx of Lyme disease twice 20010111091 1
0169764 05/11/2001 SC 1.4 1 .5 M 05/03/2001 The pt spiked a temp of 102.9, broke out in whelps to legs, arms and neck. The pt developed inconsolable crying and whining, redness and swelling to the injection site. Given Tylenol, and Benadryl. The following day the pt had developed cellulitis , swelling, warm to the touch and redness to the injection site. Treated with Keflex. Y U 05/01/2001 05/01/2001 0 NONE PVT PVT NONE NONE NONE 1
0169765 05/11/2001 WA 1.25 1 .3 M 05/02/2001 Injection site is hot, red, swollen to a 3" area at injection site. U 05/02/2001 NONE PVT PUB NONE NONE 1
0169766 05/11/2001 WI 19.0 19 F 05/07/2001 A few hours post vax the pt got hot and cold and then became light headed. The symptoms have stopped. The site of injection is soft, no redness. Denies fever. Y 05/04/2001 05/04/2001 0 PUB PVT TB NONE NONE 1
0169767 05/11/2001 KY 1.2 1 .1 F 05/02/2001 The pt developed erythema multiforme, treated with Benadryl and 5 day course of prednisolone. Y Y 03/13/2001 03/20/2001 7 NONE PUB PUB NONE NONE NONE 1
0169768 05/11/2001 GA 1.0 1 .0 F 05/04/2001 The pt experienced an injection site welt the size of a quarter and blisters appeared around injection site within a few days. Rash resolved and then bruise appeared. Y 03/22/2001 03/22/2001 0 PVT PVT NONE possible allergy to Cefzil 1
0169769 05/11/2001 IL 1.5 1 .7 F 05/03/2001 20 minutes post vax, the pt had a local reaction at the DTAP site. 2 hours later hives appeared on arms and neck. The pt also experienced a low grade fever. Treated with Benadryl and Tylenol. Y 05/01/2001 05/01/2001 0 PVT PVT NONE NONE NONE hives~Vaccine not specified (no brand name)~~1.25~In Patient 1
0169770 05/11/2001 OH 5.0 5 F 04/20/2001 2 days later, a mother called and stated her daughters arm (left arm) was swollen considerably down to her fingers. The mother was encouraged to put ice on the arm and take her to the family doctor. The doctor saw the child and confirmed reaction and placed her on Clariton. Y Y 04/11/2001 04/13/2001 2 NONE PUB PUB NONE NONE OH0024 1
0169771 05/11/2001 OH 2.0 2 .9 M 04/27/2001 This mother states the child had a localized reaction, noted 24 hours after vaccination. The site had erythema and swelling as stated by the mother. The client was seen on 04/27 erythema resolved and above knee notably edematous compared to the right leg. Low grade fever of 99 degrees, and less after the shot. Tylenol was given as ordered. Y 04/25/2001 04/26/2001 1 PUB PUB NONE NONE Allergic to dairy (milk, cheese, & chocolate). OH0022 1
0169772 05/11/2001 OH 1.4 1 .4 F 04/20/2001 This child received a 4th DTaP approximately at 9 AM on 04/17/2001. Gave her Motrin requirement because she tended to run a fever after DTaP. Did not continue Motrin on Wednesday. AM 04/18/01. The baby sitter reported an episode of whole body jerking on Wednesday in the AM. They lasted about 2 minutes. The grandmother observed same thing about 5 PM on 04/18/01. Temp was 102.5 at that time. Not checked again after that. Nothing else noted since. Y 04/17/2001 04/18/2001 1 PUB PUB OH0019 1
0169773 05/11/2001 NJ 4.0 1 .1 M 04/30/2001 The pt developed a full blown case of chicken pox that was severe. The pt was sent to an eye doctor because of the pox around the eyes. Y 04/02/1998 04/23/2001 1117 PVT PVT NONE NONE 1
0169774 05/11/2001 CA 4.0 4 F 04/23/2001 This child had a 10 x 10 cm erythematous area with slight induration at the left thigh. Y Y 04/20/2001 04/21/2001 1 PVT PUB NONE NONE CA010042 1
0169775 05/11/2001 MI 4.0 4 F 05/03/2001 This child had a 2" reddened, warm area on the left upper arm, with slight swelling on the left lower arm. Advised Benadryl and cool compresses. U 05/01/2001 05/02/2001 1 PVT PVT NONE NONE NONE 1
0169776 05/11/2001 CA 52.0 52 M 04/05/2001 This patient had a fever, muscle aches, erythema, and pain to the site. Tylenol and Benadryl. Y Y 04/05/2001 04/05/2001 0 PUB PUB NONE CA010044 1
0169777 05/11/2001 OH 0.75 0 .8 M 04/17/2001 The pt experienced a red, raised bump slightly larger than a quarter on the left leg with leg pain, that is getting worse in past 24 hours on day 7 post vax. Instructed to be evaluated by pediatrician. Pediatrician described a normal mild reaction. No treatment required. Y Y 04/11/2001 04/17/2001 6 PUB PUB NONE NONE NONE OH0023 1
0169778 05/11/2001 NV 26.0 25 F 05/01/2001 The pt developed hives and shortness of breath. Went to urgent care for treatment. Y Y 04/20/2001 04/20/2001 0 PUB PVT UNK NONE UNK 1
0169779 05/11/2001 PA 2.0 2 .2 M 05/03/2001 On 5/3/01 the pt was covered with chicken pox, treated symptoms with Tylenol for fever and Benadryl for itch. U 04/18/2001 05/02/2001 14 PVT PVT NONE NONE NONE 1
0169780 05/11/2001 TX 7.0 3 M 05/03/2001 The pt developed chicken box on 5/2/01. U 02/11/1997 05/02/2001 1541 NONE PVT OTH NONE UNK NONE 1
0169781 05/11/2001 PA 47.0 47 F 05/10/2001 The pt experienced erythema, arm tingling, numbness, right leg numbness and chills. The pt also experienced uncontrolled arrhythmia. Y N 05/07/2001 05/07/2001 0 tests - pending PVT PVT HCTZ, Pulmicort, chromium picolinate NONE congenital heart defects, tetralogy of fallot 1
0169782 05/11/2001 MO 15.0 F The pt experienced pain and weakness at the injection site, possible neuropathy. U 04/23/2001 UNK UNK NONE well child 1
0169783 05/11/2001 CA 4.0 4 M 05/01/2001 The pt experienced severe hot, raised red and white rash with accompanied pain noticed upon awakening the following morning. Motrin was given 2 hours later at the doctors office. Y U 04/18/2001 04/19/2001 1 visual exam PVT PVT PPD / Connaught NONE NONE 1
0169787 05/14/2001 IL 39.0 38 F 05/10/2001 2 days, post vax, I woke up at approx. 00:30 AM, with chest pain, shortness of breath, sweating and nausea. I was taken to ER by EMS. Ruled out MI but admitted for observation. Released the next day. Had numbness and tingling which began on the left side of my face, left arm, left side and left leg. Numbness and tingling varies in severity from day to day. Chest pain and severe numbness again on 5/2/01 with pain in the muscle where numbness present. Y Y 1 N 06/30/2000 07/02/2000 2 05/01 - EKG - Thyroid Screen, MRI, Echocardiogram. 07/00 - EKG, CV Scan. PVT PVT NONE NONE NONE 1
0169791 05/14/2001 NY 1.6 1 .0 F 05/08/2001 The pt experienced 100 spots (+) varicella. Exposed to sibling with varicella 3 days ago. Y 09/25/2000 05/03/2001 220 PVT PVT NONE NONE NONE 1
0169792 05/14/2001 MT 0.4 0 .3 M 05/03/2001 The pt experienced a fever to 103 and inconsolable fussiness the night of the vaccine. 2 1/2 days post vax, the pt had an episode of hypotonia. Y Y 04/27/2001 04/27/2001 0 NONE PVT PVT URI symptoms NONE 1
0169793 05/14/2001 CT 1.25 1 .3 M 05/09/2001 The pt experienced a fever of 102 and a seizure. Y Y 05/02/2001 05/02/2001 0 PVT PVT Tylenol Fever of 101.5 NONE 1
0169794 05/14/2001 OH 5.0 5 M 05/04/2001 The pt experienced redness and swelling at the injection site. The pt also experienced a raised, red, warm area which was non-tender on the right upper arm. Diagnosed as probable local reaction to immunization, possible cellulitis. Given Augmentin for 10 days. Y Y 05/01/2001 05/03/2001 2 NONE PVT PVT NONE NONE allergy to Bactrim 1
0169795 05/14/2001 OH 4.0 4 F 05/03/2001 The pt experiences left arm redness and swelling. Seen in the ER on 4/15/01. The left upper arm had a circular, reddened area surrounding vax site. Minimally tender to the touch, slightly warm, slightly indurated suggesting a local reaction to vax. The pt was released home in good condition. No meds given until 4/16/01. Augmentin was given per moms request. Arm was discolored for 2 weeks. Y Y 04/12/2001 04/13/2001 1 NONE PVT PVT hx of pneumonia 1
0169796 05/14/2001 OH 4.0 4 F 05/03/2001 The pt was seen in the ER on 3/25/01 because of redness and swelling, warmth and erythema involving the lateral aspect of the arm near the shoulder. The erythema stretches about 15cm from the shoulder to the elbow. Treated with water soaks, elevate arm and proscribed Keflex. Diagnosed with Cellulitis of the arm. Antibiotics changed to Augmentin. Y Y 03/23/2001 03/25/2001 2 NONE PVT PVT NONE NONE NONE 1
0169797 05/14/2001 OH 1.25 1 .3 M 05/04/2001 The pt experienced a red knot on the thigh, felt like a golf ball. On 4/21/01 the pt was seen in the ER for increased swelling and fever of 100.2. Exam revealed a 12 x 10 cm erythematous area on the anterior aspect of the right thigh. R/O infection at vax site versus delayed allergic reaction. Given IV Rocephin. Given Benadryl. Y Y 04/19/2001 04/20/2001 1 WBC - 12.9, blood culture - net PVT PVT NONE NONE NONE 1
0169798 05/14/2001 IN 2.0 M 05/03/2001 Within 1 hour the pt broke out in hives. No respiratory problems. Treated with prednisone and antihistamines. discharged home. U 05/03/2001 05/03/2001 0 UNK UNK asthma 1
0169799 05/14/2001 NJ 4.0 4 M 05/03/2001 The pt experienced a 2.5 x 2 cm area of induration, swelling, variable erythema, slightly itchy. Treated with Benadryl and watching for symptoms of cellulitis. U 05/02/2001 05/03/2001 1 PVT PVT 1
0169800 05/14/2001 MA 12.0 2 .5 F 05/06/2001 Left arm injection site is pink. U 05/04/2001 05/05/2001 1 UNK PVT PUB NONE NONE NONE 1
0169801 05/14/2001 PA 5.0 4 M 05/09/2001 The pt experienced a varicella infection 13 months post vax. Y 09/20/2000 05/08/2001 230 NONE PUB PUB NONE NONE mild asthma 1
0169803 05/15/2001 TX 1.0 1 .0 M 05/09/2001 Information has been received from a registered nurse concerning a 12 month old white male who on 03/02/01, was vaccinated with the 1st dose of MMR, subcutaneously in the left lateral thigh. It was noted at the time of vaccination, that the patient had no illnesses, allergies, birth defects, or medical conditions. On 03/05/01, the patient presented to the office with a fever of 103 - 104 for 3 days. The nurse reported has reported that the patient has also been seen in the ER and was found to have a right ear infection, nasal drainage, and a fever (Other Medical Events). The patient was treated with antibiotics and a decongestant. On 03/12/01, the patient returned to the office with a rash (Other Medical Event). The nurse reported that the patient recovered from his experiences. No further info is available. Y 03/02/2001 03/05/2001 3 PVT PVT UNK NONE WAES01050111 1
0169806 05/15/2001 TX 1.0 1 .0 F 05/10/2001 Information has been received from an RN concerning a 12 month old female who on 3/5/01 was vaccinated with the 1st dose of MMRII. The pt was vaccinated SC, in the left lateral thigh. It was noted that at the time of vaccination, the pt had no illnesses, allergies, birth defects or medical conditions. On 3/6/01, the pt experienced conjunctivitis, fever, cough and runny nose ("Other Medical Events"). The nurse noted the pt required a doctor's office visit and was treated with antibiotics and eye drops. Subsequently, the pt recovered from conjunctivitis, fever, cough and runny nose. Additional information has been requested. Y 03/05/2001 03/06/2001 1 PVT PVT UNK UNK WAES01050110 1
0169809 05/15/2001 TX 11.0 11 M 05/10/2001 Information has been received from an RN concerning a 11 year old male Caucasian with no know drug allergies, who on 8/16/00 and 9/20/00 was vaccinated with the 1st and 2nd dose of Hep-B vaccine recombinant (yeast), 0.5 ml, IM, in the left arm, respectively. This does not comply with the recommended dosage schedule. On 8/17/00, the pt developed hives on his arms and legs, a generalized maculopapular patchy skin rash on his trunk, insect bites, increased temperature, and experienced itching. The pt missed 8 days of school. On 8/23/00, the pt was seen in the ER and was given methylprednisolone acetate (Depo-Medrol) 80mg, IM, in the left dorsal gluteal. The pt recovered. On 9/20/00, the pt was administered the 2nd dose of Hep-B vaccine recombinant (yeast) 0.5ml, IM, in the left arm lot 1027K. On 9/21/00, the pt developed hives on his arms and legs, rash, itching and increased temperature. He missed 4 days of school. The pt recovered. Upon internal review, hives on the pt's arms and legs, a generalized maculopapular patchy skin rash on his trunk, insect bites, increased temperature and itching were determined to be "Other Medical Events". Additional information has been requested. Y Y 08/16/2000 08/17/2000 1 8/17/00 and 9/21/00 had a fever. UNK UNK UNK UNK WAES01020447 1
0169810 05/15/2001 NC 38.0 37 F 05/07/2001 This patient had aseptic meningitis, chronic myalgias and arthralgias. Medical Records received on 7/05/2001 states depression. Y Y N 10/27/2000 11/03/2000 7 Lumbar Puncture; Cultures and multiple others OTH OTH Luvox NONE Obsessive compulsive disorder; depression 1
0169811 05/15/2001 MN 14.0 14 F 05/06/2001 Pt became very ill within 2 hours of her vaccine. She had nausea, was weak, feverish, cold, clammy, headache and chills. She also has been bothered by a headache and a poor appetite and she did have slight discomfort in the left upper quadrant of her abdomen. She was bedridden for 10 days. The doctors denied that the shot had anything to do with her illness, so I foolishly subjected my child to the rest of the shots. We watched her continue to get sick. The doctor suggested ibuprofen or Tylenol and diet as tolerated, but he suspected it is more of a nonspecific viral illness. We have been treating her for over a year now for CFS. We travel to another state for treatment. She is still recovering. The 60 day follow-up states that the pt is much more functional; however, she periodically complains of pain, having chiils. There will be more info a year from now as to her residual symptoms. Doc 215768 states the following:"patient suffers from chronic fatique, joint pain, arthritis symptoms + depression. She is under many doctors care. All thanks to this shot. She is failing in school, misses more days than is present. This vaccine has ruined patient's life. She is a fraction of the young person she was before receiving this shot. It is travisty that this vaccine is promoted onto infants now. Why are we supporting this action? Where is the risk benefit ratio to children? If you only knew what our life has been like due to this shot, you'd work to make change, but hopefully, you'll never experience what we have gone through. Y Y N 08/12/1998 08/12/1998 0 Blood tests PUB PUB MDI inhaler PRN NONE Possibly had exercise induced asthma 1
0169812 05/15/2001 MI 60.0 60 F 05/08/2001 March 1997 - High blood sugar, treated with Micronaise. April 1997 - Diagnosed with type I diabetes. Humalog and NPH injections for 4 days. Y Y N 09/16/1996 03/01/1997 166 PUB PVT Immune Globulin/IG124 Mitral Valve Prolapse 1
0169813 05/15/2001 IL 1.25 1 .3 M 04/21/2001 This infant had a rash that broke out at the vaccination site on his leg and spread down his leg and up onto his stomach, diarrhea for nearly 1 month or more, tiny sores allover his mouth, severe salivating, high fever, red pimples around his mouth and nose, and stopped eating. He regressed, stopped talking, stopped eye contact, received a diagnosis of mild autism. Parents were devastated! Documented in his medical records and have numerous Lab work w / results to show various complications of damage from MMR and possibly others. Y N 05/30/2000 06/01/2000 2 PVT PVT Motrin NONE NONE 1
0169814 05/15/2001 IL 1.08 1 .1 M 03/21/2001 Bumps all over body. Y 03/16/2001 03/17/2001 1 PUB PUB NONE NONE NONE IL01010 1
0169815 05/15/2001 CA 0.8 0 .8 F 04/09/2001 Prevnar given on 4/4/01. Mom states pt had a fever of 103F-104F within 48 hours, post vax, that lasted until 4/9/01. CBC, blood culture, urine culture and stool done and all were negative. Y 04/04/2001 04/08/2001 4 CBC-24>10.7/30<548 83P/84 Mono OTH OTH PPD/Parkdale/01060P/LFA/0 previously NONE NONE 1
0169816 05/15/2001 NY 0.3 0 .3 F 05/07/2001 This is a 4 month old female with a history of prematurity (31 wks). She received her 2nd DTAP on 5/4/01 at approx. 11:00. 20 hours, post vax, she became fussy and 50 1/2 hours, post vax, she had inconsolable crying for 8 1/2 hours. Remained afebrile. Irritability gradually decreased over 24 hours. Y Y 05/04/2001 05/06/2001 2 NONE PVT PVT NONE Prematurity at 31 weeks. 1
0169817 05/15/2001 CA 6.0 6 F 05/09/2001 Swelling and rash at injection site. Treated with cool compress, Benadryl and protection from direct sun exposure. N 05/07/2001 05/08/2001 1 NONE PVT PUB NONE NONE Allergies to PCN, Sulfa, Novocain 1
0169818 05/15/2001 CO 0.3 0 .3 F 04/27/2001 Fussiness and crying for hours; will console to breast feed; prickly heat appearing rash on trunk; fever to 102F, onset 8 hours, post vax. Y Y 04/23/2001 04/23/2001 0 PVT UNK CO01009 1
0169819 05/15/2001 MI 1.0 1 .1 F 05/09/2001 Redness and warm to the touch on right leg. U 05/08/2001 05/09/2001 1 PVT PVT 1
0169820 05/15/2001 WI 2.0 M 05/07/2001 The pt experienced residual erythematous circular rash measuring approximately 7 x 7 cm on the right dorsal thigh. N 05/04/2001 05/06/2001 2 UNK PUB NONE 1
0169821 05/15/2001 LA 4.0 3 M 05/04/2001 The pt experienced swelling, redness and warmth from shoulder to elbow of left arm. Y Y 05/01/2001 05/01/2001 0 PVT OTH NONE NONE 1
0169822 05/15/2001 IL 1.6 1 .7 M 05/07/2001 This patient was seen on 05/01/01 for routine exam and vaccines. Appt at 4 PM, returned at 5:30 PM with full blown hives. Epinephrine Sq, and Benadryl, po administered. Resolving, NAD, smiling, and happy. Y 05/01/2001 05/01/2001 0 Coming in soon to have EGG Rast drawn. PVT PVT NONE Eczema skin condition, 02/01 peanut allergy. 1
0169823 05/15/2001 OR 0.8 0 .8 F 05/08/2001 Fever of 102.3F, pulse 160, occasional wheezing. Was given acetaminophen suppositories 80mg every 4 hours. Exam at ER on same day, was normal; exam on the next day, child was febrile, otitis, tonsillitis, fine papular erythematous rash on back. Y Y 05/03/2001 05/03/2001 0 PVT PUB Fluoride NONE 1
0169824 05/15/2001 TX 0.2 0 .2 F Spoke with this patient's grandmother, who was caring for the child at the time of the event who stated that, after taking approximately a 5 hour nap after immunizations, upon awakening the patient turned very pale, became limp, unresponsive to shaking, and her eyes were rolled back. No respiratory distress noted. The episode lasted 10 - 15 minutes. The EMS was called, upon arrival examined her and stated she was okay. Assessment was she was hypotonic, hyporesponsive reaction to DTaP. Y 04/13/2001 04/13/2001 0 NONE PVT PVT NONE NONE NONE 1
0169825 05/15/2001 NY 44.0 45 F 05/08/2001 Headache, muscle aches, feverish and chills. Given epinephrine and Benadryl. ER work-up was negative. Y Y 05/07/2001 05/07/2001 0 ER work-up-neg PVT PVT NONE NONE Erythromycin and sulfa allergies. 1
0169826 05/15/2001 MD 27.0 27 F 06/12/2000 Immediately, post vax, I experienced extreme pain at the site with diaphoresis and pain down my whole left arm. This subsided in about 5 minutes. The next day, I developed right cervical lymphadenopathy (painful) and fatigue. The local erythema and large nodule with tenderness to palpation, improved (redness about 5 days). The nodule still present after 20 days. Fatigue lasted 10 days, LAD (R) lasted about 5 days and then had left cervical LAD X 1-2 days. Had 1st JEV vaccine on 6/6/00; SC/RA. Y 05/23/2000 05/23/2000 0 MIL MIL Flonase Allergic Rhinitis Allergic rhinitis 1
0169827 05/15/2001 MD 38.0 38 F 10/30/1999 On 5/14/99, received Anthrax #3, Rabies #3, YF, MMR. At the site of Anthrax vaccine, LLR >12cm, itching, soreness X 4 weeks, flu-like, fever >102F X 3 days, arthralgias X 4 weeks. History of 2 syncopal attacks with shots due to pain. History of chest tightness/flu-like with Influenza vaccine in the past (+) responded to Motrin. Y 05/14/1999 NONE MIL MIL Albuterol prn Mild asthma, no chronic RX except prn albuterol Syncope and pain~Anthrax (Biothrax)~2~38.00~In Patient 1
0169828 05/15/2001 MD 38.0 37 M 05/02/2001 Knot and swelling at injection site. Approx. 2 months later, began to have aching in joints and severe exhaustion. Have/am still seeing 3 doctors and taking medications. Had 1st Anthrax 9/18/99 and 2nd Anthrax on 12/4/99. Y N 06/06/2000 08/01/2000 56 ANA-showed up as 40; Blood work and physical MIL MIL Zoloft 100mg NONE Allergy to pollen, etc. and seasonal allergies. 1
0169829 05/15/2001 OK 22.0 22 M 05/07/2001 Pt remained at vaccine site for 15 minutes and before leaving the site, he began to complain of feeling dizzy and weak, with a stomach ache and SOB. He reportedly, became pale and diaphoretic. Nurse reported lying him on floor. BP was 138/70. Nurse administered 0.5cc Epinephrine SC in the left arm and also had 911 called. EMS responded and checked pt and suggested family take him to ER who then prescribed Benadryl every 6 hours, Pepcid and Medrol dose/pak until seeing PCP on 10/27/00. He a pt of an allergist who is checking allergies to preservatives. Y Y 10/21/2000 10/21/2000 0 NONE PUB PVT Claritin po daily for allergies NONE Allergies of upper respiratory system. 1
0169830 05/15/2001 CO 69.0 69 F 01/29/2001 Developed hives (rash, welts) approx. 5 days, post vax. Before hives appeared had nausea and vomiting and diarrhea. Also complained of pruritus which still persists. Y Y 12/06/2000 12/11/2000 5 PUB PUB NONE CO01008 1
0169831 05/15/2001 VA 37.0 37 F 11/09/1999 24 hours, post vax, had itching in the injection site, then development of macular eczema-like lesions on trunk and arms. Y 10/29/1999 10/30/1999 1 Skin scraping MIL MIL Birth control NONE History of hernia 1
0169832 05/15/2001 OH 33.0 33 M Noted onset of rash beginning on abdomen, 3 days, post vax/HBIG, gradually spread over trunk, proximal extremities, small erythematous non-pruritic papules. Y 01/29/2001 02/01/2001 3 Skin biopsy performed with dx of pityriasis lichenoides on 3/9/01 PVT PUB HBIG/NABI/3109911/IM/0 previously; Rx OTC Actifed NONE Spring and fall seasonal hay fever 1
0169833 05/15/2001 FL 43.0 43 F 04/20/2001 On 04/12/01 had temperature of 102F, sensitivity to light, headache, achy and dizzy. On 04/15/01 temperature decreased and red spots noted to face and neck. On 04/17/01 spots faded. Y 04/02/2001 04/12/2001 10 3/28/01 Rubeola virus IgG-neg OTH PVT NONE Allergies: Sulfa; Medical conditions: Sinus and asthma 1
0169834 05/15/2001 OK 4.0 4 F 05/07/2001 On 5/3/01, child has red rash all over body. No fever. On 5/4/01, child brought into HD with nausea and vomiting and feverish and was referred to PMD. Child seen by MD. Zyrtec prescribed. On 5/5/01, mom took child to ER. No change in rash. On 5/7/01, rash remains. No nausea, vomiting or fever. Y N 05/01/2001 05/02/2001 1 PUB OTH Allergic to Motrin 1
0169835 05/15/2001 TX 5.0 5 M 05/10/2001 The pt experienced left deltoid with pink, well circumscribed, warm, swollen and slightly tender area 4-6cm. Y 05/08/2001 05/08/2001 0 NONE PVT PVT NONE NONE 1
0169836 05/15/2001 OH 0.18 0 .2 M 03/26/2001 The mother states the child developed a seizure on 2/3/01 and 5 seizures on 2/6/01. States she took child to hospital where she was treated and tested. MD informed mother not to get DTP again. Y Y 01/25/2001 02/03/2001 9 EEG and lab tests PUB PUB NONE NONE NONE OH0026 1
0169837 05/15/2001 SC 13.0 13 F 05/01/2001 On 4/29/01 the child began breaking out with itchy whelps all over body, most on abdomen and chest. Mother denies switching detergents, soaps etc. States only received vaccine. Treated with over the county Benadryl. U 04/25/2001 04/29/2001 4 NONE PUB PUB NONE NONE NONE SC0128 1
0169838 05/15/2001 GA 4.0 4 F 05/07/2001 ? hives on left lower arm. Treated with po Benadryl at 22:10. Temperature 99F, pulse 98 and respirations 20. No redness and not raised around injection site. No difficulty with respirations. Y 05/07/2001 05/07/2001 0 PUB PUB NONE 1
0169839 05/15/2001 AR 4.0 4 F 03/19/2001 Approx. 24 hours, post vax, pt developed temperature of 104F. Motrin given and temperature decreased to 100F. Mother states is giving every 4 to 6 hours. When Motrin wears off, temperature increases again. Has been going on X 4 days. Call to mother on 4/1/01, said pt ill X 2 days and temperature did not exceed 104.9F. Y 03/16/2001 03/17/2001 1 PUB PUB NONE NONE NONE AR0124 1
0169840 05/15/2001 TX 20.0 20 M 05/08/2001 At 11:00, pt complained of "not feeling right", was pale, diaphoretic, (red) rash beginning to appear on chest and neck. Also, pt complained of shortness of breath. At 11:01, laid pt in prone position and administered Benadryl 50mg, IM and Epi 1:10000, 0.3ml, SQ. Given O2 via NC. Vital signs: HR 70, BP 108/58; RR 20. Pt transported to ER via EMS. Y Y 05/05/2001 05/05/2001 0 PVT PVT NONE Has had allergic reaction while camping-source unknown. 1
0169841 05/15/2001 WI 1.4 1 .5 M 05/07/2001 Child received attached immunizations at 3 months at 15:30. Mothers reports she thinks child is having reaction. Child is pale, sleepy and "knees buckled" when placed in standing position. Temperature 99.6F (ear); able to walk when observed by RN. At 16:00, temperature was 101.6F (ear); sleeping and lethargic. Has no Tylenol and no local MD. Instructed to go to ER. On 5/5/01, pt spiked fever of 105F. Mother took child to Urgent Care Center. Fever was reduced to 102F. Mother states that personnel there, reported he had no other signs of infection. As of 5/7/01, at 09:45, pt still has a fever about 102F with being treated with Motrin/Tylenol alternately. Y U 05/04/2001 05/04/2001 0 PUB PUB IPV/T0562 by Aventis given in right arm with 2 previous doses on 05/04/01 NONE NONE 1
0169842 05/15/2001 MI 3.0 1 .5 F 05/09/2001 Had varivax on 10/8/99. Today presented with varicella rash with about 8 lesions. No other symptoms. Has it presently. N 10/08/1999 05/09/2001 579 PVT UNK NONE 1
0169843 05/15/2001 VA 1.08 1 .1 M 03/03/2001 About 4 hours, post vax, fever sharply came on to 103.1F (axillary). He became very lethargic and whimpered. Tylenol did not reduce fever so after 6 hours, gave children's Advil which eventually put him to sleep and fever went to 100F. Y 02/06/2001 02/06/2001 0 PVT PVT Eczema 1
0169844 05/15/2001 NC 57.0 57 F 05/07/2001 Started night of immunization with rash, abdominal pain, nausea and vomiting. Had a fever up to 102F, over the weekend but much better now, at times is 100F. Had muscle aches and joint pain but is better. Also, nausea and vomiting is better. No treatment. Y 05/03/2001 05/03/2001 0 PUB UNK NONE NONE 1
0169845 05/15/2001 CA 5.0 5 F 05/07/2001 10cm X 8cm erythematous, inflammed patch over right deltoid. No systemic reaction. Y 05/02/2001 05/04/2001 2 NONE UNK UNK PPD/Connaught/0150AA/RFA/0 previously NONE NONE 1
0169846 05/15/2001 MI 58.0 57 F 05/07/2001 The pt had prickly itching from elbows to shoulders on both arms, spreading to chest, neck. Has "sores" from scratching. Pressure in chest lately. N 11/03/2000 OTH OTH Estradiol NONE NONE 1
0169847 05/15/2001 IL 2.0 2 .1 M 05/08/2001 Pt went to ER on 5/8/99, 5/9/99 and 5/11/99 with a 105F-106F fever. He was taking Tylenol and Motrin (alternating) over 3 hours, in addition to cool baths. I could not break the fever. At the time, I was on vacation and no one would believe me, that this was a reaction. He was weak. They said he had an ear infection but he did not have a cold. Dx'd with Autism. Y U 04/30/1999 05/08/1999 8 Autism PVT PVT NONE NONE NONE ~Measles + Mumps + Rubella (MMR II)~1~1.50~In Sibling 1
0169848 05/15/2001 MI 4.0 4 F 05/04/2001 Pt presented with parents on 4/30/01 with a 3 day history of fever, left jaw and mouth pain on sour taste (challenge with lemon) and edema and redness and intermittent torticollis on left. MMR given on 4/24/01. At exam, well check, cerumen in ears and allergic rhinitis expected. Development appropriate for age. Y Y 04/24/2001 04/27/2001 3 None PVT PVT Tylenol given po before shots Allergic rhinitis suspected Eczema; no allergies to food or medicines 1
0169849 05/15/2001 IN 12.0 12 M 05/07/2001 The pt experienced shortness of breath, sounds congested, eyes were red, was jittery, felt dizzy. BP 110/80, P 124. Benadryl given. Y 05/04/2001 05/04/2001 0 PVT PUB Imapramine NONE NONE 1
0169850 05/15/2001 GA 1.3 1 .3 F 05/07/2001 Injection Y 04/24/2001 04/26/2001 2 PVT PUB NONE 1
0169851 05/15/2001 MO 5.0 5 F 05/08/2001 2cm area of erythema at injection site for 72 hours. Y 05/05/2001 05/06/2001 1 NONE PVT PUB NONE NONE 1
0169852 05/15/2001 MA 4.0 4 M Swelling and redness on right upper arm with induration about 5cm X 5cm. Y 04/23/2001 04/25/2001 2 NONE OTH PUB NONE NONE 1
0169853 05/15/2001 CA 6.0 5 F 05/04/2001 Right deltoid immunization site with swelling, erythema and tenderness but is improving. Y 05/01/2001 05/02/2001 1 PUB PUB Pt prescribed Benadryl NONE 1
0169854 05/15/2001 CO 2.0 1 1 F 05/08/2001 Redness, swelling, warm to touch over area about 5cm X 6cm and tissues are hard and tender. U 05/04/2001 05/05/2001 1 PVT PVT NONE NONE NONE 1
0169855 05/15/2001 IL 51.0 51 F 03/14/2001 The pt complained of pain at the injection site down to the elbow. Pain also experienced in left side of back. Describes pain as muscle ache. Denies fever and redness at site of injection. The pt states "just don't feel well". The pt was better on 3/15/01. Y 03/12/2001 03/13/2001 1 PUB UNK IL01011 1
0169856 05/15/2001 MI 29.0 29 F 05/01/2001 24 hours post vax the pt experienced flu like symptoms, entire back pain, possible fever, had chills and hot feeling. Arthritic pain in all joints, no headache. Slept 10 hours each day for 2 days. Y 03/30/2001 03/31/2001 1 UNK UNK NONE 1
0169857 05/15/2001 WA 34.0 34 F 05/09/2001 The pt experienced nausea and vomiting, shortness of breath, wheezing, elevated blood pressure. The injection site appeared red, inflamed, raised. The pt was given Benadryl. Y Y 05/02/2001 05/02/2001 0 NONE MIL MIL Tegretol, Floricett NONE NONE 1
0169858 05/15/2001 CT 1.25 1 .2 F 10/28/2000 This patient experienced a low grade fever, light red rash starting on her face and progressed to her abdomen and extremities. Discomfort, runny nose, swollen lymph nodes, and pain in her ears. The rash spread for about 3 days. Y 10/06/2000 10/18/2000 12 PVT PVT NONE NONE NONE 1
0169859 05/15/2001 CA 5 M 05/03/2001 This patient had a local reaction, 4 x 4 erythema scratch in the center. U 05/01/2001 05/01/2001 0 NONE PUB UNK NONE 1
0169860 05/15/2001 CA 26.0 26 F 05/01/2001 Administered MMR and client broke out in a rash 3 - 4 days after. She went to the ER and was told she had contact dermatitis. Y U 04/18/2001 04/22/2001 4 UNK PUB PUB NONE CA010046 1
0169861 05/15/2001 CA 14.0 14 F 05/04/2001 The pt experienced a syncopal episode 5 minutes following vax which lasted 15 seconds. The pt recovered fully following 10 minutes of observation. Y 05/01/2001 05/01/2001 0 BP - 134/80, P - 80 PUB PUB NONE NONE NONE CA010045 1
0169862 05/15/2001 FL 48.0 48 F 05/09/2001 This employee had an outbreak of rash on her trunk, back, bilateral arms, and groin area 12 days after injection. Sent to the physician for evaluation. Y 04/20/2001 05/02/2001 12 PUB OTH NONE NONE 1
0169864 05/15/2001 HI 0.25 0 .2 M 02/21/2001 An LPN called the mother of this patient on 02/21/01 to remind her of her son's immunizations. The mother stated that her son had "cried for 3 hours non-stop" later that day. The mother reported that she had to take her son to see his pediatrician on 12/21/00 and was directed to give Ibuprofen and take only D.T. in the future. Y 12/20/2000 12/20/2000 0 PUB PUB NONE NONE NONE 1
0169865 05/15/2001 MI 20.0 20 M 04/13/2001 2 hours after receiving Menincoccal mening vaccine patient experienced pain in the left axilla. A few hours later a few bumps noted. The next day bumps were pustules. A Z-pak was given, avoid deodorant, use antibacterial soap Y U 04/11/2001 04/11/2001 0 NONE PVT PVT NONE NONE 1
0169866 05/15/2001 CO 41.0 41 F 04/26/2001 This client received Hepatitis B # 3and then went on a hike where she started breaking out in hives at the injection site, and it started spreading all over her body. The client sat in a hot tub that evening and more hives occurred. Breathing was not compromised and she did not seek medical attention. She did start taking over the counter Benadryl. Y 04/19/2001 04/19/2001 0 PUB PUB NONE Lyme disease. Allergies to, Latium & Sulfa. CO01006 1
0169867 05/15/2001 NC 51.0 51 F 05/07/2001 Vasomotor response, then complains of dizziness, blurred vision, pounding headache in the back of the head then moved to the front of his head, forehead area. Here 1 1/2 hours when leaving complained of itching all over. Had a fever over the weekend and a headache. Much better. U 05/07/2001 05/07/2001 0 PUB UNK NONE NONE Allergic Formaldehyde. 1
0169868 05/15/2001 NJ 6.0 6 M 04/24/2001 On 4022/01 phone call from a school nurse. Child complained of redness and soreness at injection site, left deltoid, temperature of 99 (oral). Shot given Friday, 04/20/01, soreness started 04/21/01, mother applied cool compresses. Encouraged mom to take the child to PMD. On 04/25/01, PMD diagnosed infection at the injection site from the child scratching. RX: Neosporin and warm compresses. Site much improved as per mother, no fever. Y Y 04/20/2001 04/21/2001 1 PUB PUB NONE NONE NONE 1
0169869 05/15/2001 NJ 22.0 22 M 05/07/2001 One week after 3rd Imovax, the patient had dizziness, fever, nausea, diarrhea, bloating, and malaise for 4 days. U 04/25/2001 05/02/2001 7 PVT PVT 1
0169871 05/15/2001 IL 40.0 39 M 05/01/2001 This patient was given Pneumococcal vaccine on 03/12/01, later that evening he complained of pain, and redness at the site of injection. The pain was severe. Missing vaccine information not available. Y 03/12/2001 03/14/2001 2 NONE PUB PUB 1
0169872 05/15/2001 VA 72.0 72 M 05/10/2001 This patient had a fever of 102 - 103, arm was swollen and sore. The sickness lasted 2 days. Y Y 03/27/2001 03/27/2001 0 PVT PVT NONE NKDA, Hypertension, elev Chol, CRI s/p CVA, seizure disorder, abestosis. 1
0169875 05/16/2001 TX 37.0 37 F 05/10/2001 A 37 year old female was hospitalized on 04/27/01 for neck stiffness, myalgia, nausea, and tiredness. She had received an accidental overdose of RabAvert for post-exposure prophylaxis. The patient received post-exposure prophylaxis because she was bitten on the hand by a skunk (she raises skunks). On 04/27/01, the patient received 5 cc of RabAvert (lot #277011) instead of human rabies immune globulin (HRIG); 1 ml was given subcutaneously in each of the 2 fingers that were bitten, and 3 ml was given intramuscularly in the deltoid region. The patient was exposed to rabies 2 years ago, but never received post-exposure immunization. The patient's physician stated that the 5 vials of RabAvert, which were obtained from the Texas Dept Of Health, were held together with a single rubber band. He believed that this may have confused the nurse who administered simultaneously, and thereby resulting in overdose. The patient developed myalgia, nausea, neck stiffness, and tiredness following the injections on 04/27/01. She also had a sore deltoid muscle at injection site. She was hospitalized overnight for observation and was discharged from the hospital on 04/28/01. As of 04/30/01, her symptoms had improved considerably. After consultation with the Texas Dept of Health, the physician elected to continue the patient's treatment course with RabAvert. She received 1 ml intramuscular injections on 04/30/01 and on 05/04/01. The patient was then transferred to another physician for care, and the reporting physician expects that the patient will complete the course of RabAvert. Y 1 N 04/27/2001 04/27/2001 0 OTH OTH NONE UNK This patient was exposed to rabies 2 years ago, but never received post-exposure immunization. At the present situation, the patient was bitten on the hand by a skunk (she raises skunks). EM20010567 1
0169876 05/16/2001 WA 17.0 17 M 02/15/2002 Information has been received from a health care professional concerning a 17 year old male who on 12/12/00 was vaccinated IM with one dose of Hepatitis A virus vaccine inactivated. Concomitant therapy on 12/12/00 included a first dose IM of Typhoid VI polysaccharide vaccine (Typhim VI) and a sixth dose of poliovirus vaccine (IPOL). On 01/04/01, the patient was vaccinated IM with a 2nd dose of Typhoid VI polysaccharide vaccine (Typhim VI) (lot #R0384). It was reported that a few days before 01/19/01, the patient had complained to his mom about spasms in his right hand. On 01/19/01, after going to a high school play, the patient was driving home and had such a severe spasm in his right hand and arm that he was unable to drive or steer the car and went off the road into a ditch. The patient sustained no injuries from the accident. ON 03/05/01, the patient started taking malaria pills. Then on 03/12/01, he took two pills while in another country. While there, the patient continued to have spasms on the right side of his body, on of which was so severe, he fell to the ground with his eyes rolled back, but was able to hear those around him and could respond verbally but was unable to move. When the spasm was over he could move again. The patient was taken to his primary care physician when he returned. At that time he was taken off his malaria medication. The patient continues to have increasing dizziness, which is sometimes accompanied with headaches and neck stiffness. The patient describes the dizziness as feeling like he is walking during an earthquake. The patient has been to a chiropractor more than once after 01/19/01. He has also experienced high blood pressure, which fluctuates between high and normal. Besides the dizziness, he complained of blurred vision. The patient has an appointment with an eye specialist on 05/02/01. He has not had any cold, sinus infection, fever, nausea, or vomiting. It was reported that he has had a "nervous stomach" and has bouts of diarrhea frequently. He has been checked for bowel problems with no specific bacteria or viral infections found. He was given "Meclovir" to treat the dizziness and possible middle ear infection. It was noted that the patient has had no spasms since returning from the other country. Additionally, it was noted that the patient has had an appointment regarding his blurred vision. There was no MRI or neuro testing done for the dizziness and spasms. The patient's experiences were determined to be Other Medical Events. No further info is available. Follow-up info from a health professional reported that the pt had an eye examination which was normal. He was seen by a neurologist who said the dizziness would disappear. As of 10/01/2001 the dizziness occurred once a month. It was noted thatt he pt had a second dose of hep A virus vaccine inactivated on 04/19/2001 with no problems. Additiomally, it was indicated that the nurse gave the second dose too early so the pt received a third dose on 10/01/2001 without any problems. The pt recovered in March 2001. Y Y 12/14/2000 01/19/2001 36 PUB PUB NONE ~DTP (no brand name)~1~0.20~In Sibling WAES01051069 1
0169877 05/16/2001 AZ 2.0 2 .9 M 05/04/2001 This patient complained about arms hurting and getting hot. He then had multiple episodes of vomiting. The patient got very pale with staring, and his heart rate increased. He then became limp and lifeless and eyes rolled back. This lasted for about two minutes. While hurrying to the ER, the patient went into a seizure and the mother even thought he had died. The ER doctor said it was probably a reaction the the shots. Y Y Y 1 Y 05/01/2001 05/01/2001 0 High white blood cells. PUB PUB NONE NONE NONE 1
0169880 05/16/2001 FL 38.0 38 F 05/09/2001 This patient had severe generalized fatigue, pain, numbness at many areas of her body; chronic muscle spasms, soft tissue swelling. Diagnosed with fibromyalgia / CFS. The 60 day follow-up states fibromyalgia and chronic fatigue. Per doc 214743, chronic muscle pain, fatigue, disabled, unable to move now for 2 years patient was able to work before. The follow up received on 6/13/01 states, "the pt basically has the same complaints she had last time she was in. Unfortunately, other than for the sleep study and neurologic evaluation by Dr, none of the tests that were ordered at hospital were actually performed. The pt still has chronic fatigue as well as numerous musculoskeletal type pain, most notably in the neck and back. She still has trouble swallowing from time to time, however, she does not wish to undergo work up for this at this time. She has not had fever or headaches. She claims there is some element of depression, although she feels this is probably due to the way she feels. Impression: fibromyalgia, history of thyroid nodule, dysphagia, diffuse back pain most notably affecting the C-spine secondary to fibromyalgia/? concomitant degenerative joint disease or other etiology, allergic rhinitis, status post ablation of accessory pathway for Parkinson-White syndrome, menorrhagia/anemia/stopped iron due to gastirc upset, hypotension on the past couple of visits. Endocrinologic evaluation was recommended to rule out adrenocortical insufficiency. Plan: previously recommende tests will once again be ordered. Encocrinologic evaluation is once again recommended. Check labs. Begin Desipramine 1/2 of 25mg tablet qhs for a week and then 25mg tablet qhs thereafter. Reevaluate in a few weeks or prn." Missing vaccine informaton not available. Follow up: patient states she is permanently disabled, unable to work. Still with symptoms of severe fatigue, and generalized body pain and numbness, mostly on left side of her body. Y Y N 10/31/1995 10/31/1995 0 H and H low at that time; trigger points-all test positive for F/M PVT OTH NONE Allergies: Eggs, environmental allergies: pollen, trees, can't remember what else. 1
0169883 05/16/2001 LA 0.16 0 .2 M 05/10/2001 Child was given DTAP, Comvax and Prevnar on 3/8/01 and within hours, child became febrile and irritable. Fever continued and was admitted for rule out of sepsis; LP; Blood cultures; and IV antibiotics X 3 days. All cultures were negative. Child recovered. Y 3 Y 03/08/2001 03/08/2001 0 Blood cultures, CSF's neg PVT PVT NONE NONE 1
0169884 05/16/2001 MD 0.8 0 .2 M 05/11/2001 One week post vax, the pt developed constipation and poor feeding, lethargy and hypotonia, now resolved. Y 3 Y 04/28/2001 05/04/2001 6 CT of head-nml; Blood culture and CSF culture-(-); Glucose 52/protein 38.4 PVT UNK 1
0169886 05/16/2001 NJ 0.5 0 .5 F 05/11/2001 The mother of a 6 month old female reported that her daughter received injections of Prevnar and DTP on 8/24/00. The pt had no pre-existing illnesses and was receiving no medications concomitantly. Eight days, post vax, on 9/1/00, the pt awoke from a nap and was unable to open her eyes initially. When she was able to open them, they were "so sensitive to light" that she could not go outdoors. She also had a fever of 104F. She was taken to an ER where meningitis was ruled out. On 9/4/00, she was admitted to a hospital because the symptoms had not resolved, and she was, subsequently, dx'd with bilateral uveitis. The pt was treated with prednisone which "helped". In March, 2001 (approximately), the pt's symptoms returned and she again began prednisone therapy, to which she was noted to be responding. Prednisone therapy continues. Y Y N 08/24/2000 09/01/2000 8 Temperature of 104F PVT OTH NONE NONE UNK HQ0768311MAY2001 1
0169887 05/16/2001 IL 2.0 2 .7 F 04/23/2001 Pt experienced swelling and redness of upper right arm which improved over a weeks time. Y 04/14/2001 04/15/2001 1 PUB OTH NONE NONE IL01012 1
0169888 05/16/2001 NC 0.2 0 .2 M 05/08/2001 Approximately six hours post vax, the pt had 15 - 20 small purpuric lesions on both lower legs. No other symptoms. Y 05/03/2001 05/03/2001 0 CBC, coags, blood culture all normal/negative PVT PUB NONE NONE NONE 1
0169889 05/16/2001 HI 0.3 0 .3 M 05/09/2001 Pt developed a low grade fever one day post vax which resolved within 12 hours. Six days post vax the pt developed a red, papular rash that is spreading from face to the torso. Y U 05/02/2001 05/08/2001 6 Stool culture positive for Clostridium botulinum per follow up information received 06/15/2001. PVT PVT NONE NONE NONE 1
0169890 05/16/2001 FL 1.25 1 .3 M 05/10/2001 Pt experienced some redness, swelling and warmth accompanied by tenderness to the left anterior thigh with mild cellulitis. Y U 05/08/2001 05/09/2001 1 NONE PVT PUB NONE NONE NONE 1
0169891 05/16/2001 TN 1.0 1 .0 M 05/01/2001 The morning following vax, the pt developed a fever. The pt presented that afternoon to physician with a fever of 103. No abnormality noted. Pt also experienced loose stool. Y U 04/30/2001 05/01/2001 1 CBC - 15200 WBC 14% Lymph 86% Gran PVT OTH NONE NONE NONE 1
0169892 05/16/2001 IN 0.25 0 .2 F 05/07/2001 Vaccine given 02/26/01; presented on 4/2/01 with petechial rash and platelet count 2,000. Dx'd with ITP by Labs and Bone marrow aspiration. Y U 02/26/2001 04/02/2001 35 PVT PVT NONE NONE Physiologic GE Reflux 1
0169893 05/16/2001 MI 1.0 1 .0 F 05/09/2001 Within 24 hours, post vax, developed fevers of 102F-105F. 30 hours, post vax, had a brief febrile seizure. Y Y 05/07/2001 05/08/2001 1 CBC, U/A, and CXR-all normal PVT PVT NONE NONE 1
0169894 05/16/2001 NY 66.0 65 M 10/09/2001 On 4/20/99, 5/12/99 and 5/12/00, the pt received his 1st, 2nd and 3rd doses of Lymerix vaccine. Nine months after the 3rd dose, on 3/10/01, the pt experienced headache, facial pain, general malaise, alternating stiff joints and photophobia. A spinal tap was performed. CSF, reportedly, contained elevated protein. An ELISA and Western Blot were "positive for 3 bands but not the same as for the vaccine". The pt was seen by his PCP and a neurologist. A 20 day course of doxycycline was started on 4/27/01. The reporter was not sure of the causality of the adverse events with regard to Lymerix. As of 5/10/01, the outcome of the adverse events was unresolved. The adverse events of 'headache' and 'stiff joints' do no meet serious criteria, but are being submitted as an expedited report by special FDA request per the 6/28/00 letter. Additional info was received from the vaccine provider, who is the vaccinee's primary care physician, on 08/03/2001. The physician reported that the vaccinee began to experience vertigo on 02/12/2001, this was described as "equibilrium off each AM." On 04/12/2001 the vertigo persisted and the vaccinee began to experience frontal headache and weakness. The physician discontinued terasosin therapy on 04/12/2001. The headache, vertigo, and weakness persisted. On 06/07/2001, triamtergne/hydrochlorothiaside therapy was discontinued, and the vaccinee's hypertention was treated with candesartan and hydrodhlorothiazide. The frontal headache, vertigo, and weakness resolved on 06/24/2001. The physician did not confirm the spouse's report of stiff joints, photophobia, or elevated CSF protein. The physician did not report findings of an ELISA or Wetern blot analysis. The physician indicated that the vertigo, frontal headache, and weakenss were of mild intensity and not related to LYMErix administration. The physician stated, "pt had no adverse reaction to vaccine administration." As of 08/03/2001, the vertigo, frontal headache, and weakenss had resolved. The outcomes of the stiff joints and photophobia were unknown, since these events were not confirmed by the physician. Y Y 05/23/2000 02/12/2001 265 Spinal Tap-CSF showed elevated protein; ELISA test-"positive for 3 bands"; Western Blot test-"positive for 3 bands" but not the same as for the vaccine. PVT PVT Acetylsalicylic acid; triamterene hydrochlorothiazide; hydrochlorothiaeide, candesartan, terazosin Hypertension and appendectomy (20 years ago), benign prostatic hyperplasia 20010116431 1
0169895 05/16/2001 GA 43.0 41 M 05/01/2001 The 1st 3 doses of Anthrax in 1999 caused small / mild local reactions. During and after last 3 doses in 2000 noted worsening lt shoulder / scapular region pain and muscle spasm. Follow up on 05/31/2001: "Patient partially recovered from adverse event. lack of energy/constant tiredness, malaise, reduced concentration, short term memory loss." Y N 07/23/1999 07/28/1999 5 Arthritic labs - Neg. C-spine MRI - mild bulge at C5-6. NCU test of arms - Nml. MIL MIL Celebrex NONE Recurrent back strain, eczema, MVA 03/00 and 03/01. 1
0169896 05/16/2001 MO 11.0 11 F 04/30/2001 Post vax, pt had small red lumps on inner forearm (L) and 1 bump on (R) inner forearm. She complained of problem breathing, about 1 hour, post vax. Y 03/19/2001 03/19/2001 0 PUB PUB NONE NONE NONE MO2001027 1
0169897 05/16/2001 CA 1.6 1 .5 F 05/07/2001 Rash all over body, fever, diarrhea, behavioral changes, 7 to 12 days after vaccines was given. Pt was given Benadryl and D/C all other meds. U 04/20/2001 05/01/2001 11 NONE PVT PUB NONE NONE 1
0169898 05/16/2001 WA 2.0 2 .1 F 05/08/2001 This child developed edematous 4" x 5" area with discrete borders. The area was red, tender, and warm to touch. Some yellow discoloration noted within. The patient was placed on Cephalexin four times daily. Y Y 05/02/2001 05/03/2001 1 PVT PUB NONE NONE 1
0169899 05/16/2001 TX 1.5 1 .5 M 05/09/2001 The mother states the pt broke out in rash 3-4 days post vax. Y 04/24/2001 04/28/2001 4 PVT PUB NONE NONE 1
0169900 05/16/2001 CO 5.0 5 M 05/03/2001 The pt received the vaccines on 4/30/01/ and was presented on 5/2/01 with erythema 1 1/2 x 2 1/2 inch circular area just outside of the site of vaccine. Y Y 04/30/2001 05/02/2001 2 PVT UNK NONE esotropia, Prader-Wills Syndrome, hypotonia 1
0169901 05/16/2001 CO 1.25 1 .3 M 05/09/2001 The pt experienced a hive on the leg the size of a plum that was warm to the touch. The pt was treated with Keflex and Benadryl. Y Y 05/03/2001 05/05/2001 2 PVT PVT 1
0169902 05/16/2001 LA 1.5 1 .3 F 11/09/2000 This infant had a fever of 103 F, 50 - 100 chicken pox rash, refused to eat, and irritability. Y Y 09/05/2000 09/15/2000 10 PUB OTH Amoxicillin NONE Allergies to previous immunization. 1
0169903 05/16/2001 VA 1.0 0 1 M 05/10/2001 Mother says that child ran fever of 102F and had a seizure at about 14:30. Mom had given Tylenol. Was taken to ER and was told that seizure was due to immunizations. Y Y 05/08/2001 05/08/2001 0 NONE PUB PUB NONE NONE 1
0169904 05/16/2001 PA 15.0 15 M 05/09/2001 Pt felt ill and feverish for 1 day, post vax. Pt's arm was red and sore at the injection site about 2"-3". As of 5/9/01, is still sore and firm, but is improving. It is no longer red. Y 05/03/2001 05/04/2001 1 NONE PVT UNK NONE 1
0169905 05/16/2001 TX 3.0 3 M 05/09/2001 Red wheals on arms and chest, within 24 hours, post vax. Y 05/08/2001 05/08/2001 0 PVT PVT Sudafed Runny nose Hypospadias Wheals~Measles + Mumps + Rubella (no brand name)~1~1.00~In Patient 1
0169906 05/16/2001 WI 71.0 71 F 05/09/2001 Pt called on 5/9/01 to report persisting weakness and nausea. "Feeling debilitated since Typhoid vaccine on 4/24/01 at 09:00. Awoke at 23:00 with severe headache all over "thought it was aneurysm" lasted hours, red chest rash for 2 1/2 days; nausea and debilitating feeling persists. Usually acting on treadmill for exercise. Has pushed to take walks past days to prepare for trip but no strength. Can't resume normal eating and exercises secondary to symptoms. Y N 04/24/2001 04/24/2001 0 PVT PVT HCTZ URI, had "cold" no fever PCN allergy 1
0169907 05/16/2001 TX 4.0 4 F 05/09/2001 Right arm with 4" X 3" area of erythema, central area of duskiness and increased warmth and tenderness. Full ROM. Treated with Motrin for pain and Benadryl and warm compresses. Y Y 04/26/2001 04/27/2001 1 NONE PVT PVT NONE NONE RAD; Eczema 1
0169908 05/16/2001 CA 4.0 4 M 05/07/2001 Local erythema and induration at injection site involving about 2/3 of right thigh, around DTAP injection. Treated on 4/26/01 by family NP with Augmentin. No fever or other systemic symptoms. Y Y 04/23/2001 04/25/2001 2 NONE PVT PVT NONE NONE NONE ~DTaP (no brand name)~5~4.60~In Sibling 1
0169909 05/16/2001 NY 5.0 5 F 05/09/2001 The pt experienced an erythematous slightly indurated area measuring 9" x 6 1/2". Y 05/07/2001 05/08/2001 1 PVT PVT NONE allergy 1
0169910 05/16/2001 MA 5.0 M 05/09/2001 This patient right deltoid area was pink, swollen, and slightly tender. The mother was instructed to apply ice, give Benadryl, and Tylenol for the pain, as directed on the bottle. U PVT PUB NONE Allergic to Amoxicillin (hives). 1
0169911 05/16/2001 MA 15.0 15 F 04/26/2001 The pt experienced fatigue, runny nose, sore throat and no temp. The pt also experienced swelling of the left eye with discoloration. The next day the pt experienced swelling under both eyes, lips slightly swollen, Treated with Benadryl. Y 04/03/2001 04/05/2001 2 NONE OTH PVT NONE NONE NOEN 1
0169912 05/16/2001 KY 19.0 19 F 05/08/2001 After Hepatitis B # 1, this patient had vomiting and diarrhea 1 week after the injection, and it lasted 1 - 2 days. Hepatitis B # 1 done on 04/05/01. Hepatitis B # 2, had on 05/05/01, the patient had vomiting, dizziness, was light headed, rash on the left arm, and a bruise on the right leg and left arm. Her sickness started 11 - 12 hours after the injection. Y 05/07/2001 05/07/2001 0 PUB UNK NONE 1
0169913 05/16/2001 IL 0.2 0 .2 F 05/08/2001 Noticed 1 hive0like appearance on infant's forehead 2 - 3 hours later. The mother breast feeding solely and says she didn't recall any changes in her diet. Y 04/17/2001 04/17/2001 0 PUB PUB Tylenol infant drops. NONE NONE 1
0169914 05/16/2001 NY 5.0 5 M 05/10/2001 This child mother states that she had not noticed the reaction x 1 1/2 days after the shot, but the child states it was there by the next day. His right upper arm was red, very hot, with a lot of swelling. The mother also noticed white spots under skin where are was swollen. The mother applied cold cloths, ice packs, and gave Tylenol every 4 - 6 hours. The patient states his arm was sore. All of this lasted about 8 days. Today 05/10/01, the patient's arm was "perfect" per mom. Y 05/01/2001 05/02/2001 1 PUB PUB NONE NONE NONE 1
0169915 05/16/2001 CA 1.25 1 .3 M 05/09/2001 A phone call from the Mother states the pt suffered a "seizure" at the day care provider that was described the pt as "flailing about" lasting 1 1/2 minutes. The pt was taken to the ER. No fever was reported and the pt was released. Y U 05/08/2001 05/09/2001 1 PVT PUB 1
0169916 05/16/2001 MS 0.5 1 .5 F 05/03/2001 Immediately, post vax, the MMR in left upper arm, a 2"-3" area around the injection site became red and inflammed. Child observed about 20 minutes in clinic with no visible signs of a systemic reaction. Mom was advised to watch site and if not improved or if worsens in the next 24 hours, to see MD. U 05/03/2001 05/03/2001 0 PUB PUB NONE Allergy to Rocephin MS01016 1
0169917 05/16/2001 NM 1.7 1 .7 F 05/10/2001 This infant had a local reaction at the left deltoid site of DTaP # 4. She had swelling, redness, and itching that started on 05/09/01 at 1:00 PM. She was seen by a doctor on 05/09/01 at 5:00 PM. Not cellulitis. Home treatment with Benadryl PO and Ice to the site. Y Y 05/07/2001 05/09/2001 2 NONE PVT PUB NONE NONE NONE 1
0169918 05/16/2001 AZ 1.0 1 .0 M 05/07/2001 This infant had redness on left upper arm. Y 1 Y 05/03/2001 05/04/2001 1 CBC - Nml. Blood Culture - No growth. PVT PVT NONE NONE NONE 1
0169919 05/16/2001 CT 4.0 4 F 05/04/2001 This child had a swollen, hot upper left arm, since the PM of the vaccines given. Instructed to apply cool compresses. The father stated the site "is better today", the patient denies pain. Y 05/04/2001 05/04/2001 0 PVT PUB NONE NONE 1
0169920 05/16/2001 AZ 2.0 1 .0 M 05/08/2001 This patient was seen to have a classic Varicella compatible with history of onset 4 days ago; seen with hands red of lesions on the 4th day of illness 05/07/01, no new lesions then but expected. Y U 11/18/1999 05/03/2001 532 Examination from pediatrician, practicing since 1971. PVT PVT Amoxicillin Recent recovery from pharyngitis and otitis media. NONE 1
0169921 05/16/2001 MN 1.0 1 .0 M 05/09/2001 This infant had a pruritic rash onset 1 week after vaccine administration. Had rash on 04/27/01 and bilateral otitis media. Started on Amoxicillin. U 04/27/2001 05/04/2001 7 PVT PVT Amoxicillin Bilateral otitis media. NONE 1
0169922 05/16/2001 PA 5.5 5 M 05/19/2001 This child had a temperature of 102, and a headache less than 24 hours. Y 05/07/2001 05/08/2001 1 PVT PVT NONE NONE NONE 1
0169923 05/16/2001 IL 2.0 2 .1 M 05/11/2001 This child had an 8 cm firm, red, hot area at the site of injection. The thigh was very swollen and tight, with red streaks extending toward the knee. Recommended MD visit. No fever, no pain or soreness. U 05/09/2001 05/10/2001 1 PUB PUB NONE NONE NONE 1
0169924 05/16/2001 MA 65.0 65 F 14 hours post vax. the pt experienced stomach pain with feeling like vomiting. Y 05/01/2001 05/01/2001 0 PVT UNK 1
0169925 05/16/2001 IL 1.5 1 .6 F 04/18/2001 10 hours after receiving shot she vomited 4 times and had a fever of 102.3. Temperature was back to normal within 24 - 48 hours. The mother states that there was no rash or respiratory involvement and no local reaction. The infant was alert and active but appeared tired for 24 - 48 hours. Y 02/12/2001 02/12/2001 0 NONE PUB PUB NONE NONE NONE 1
0169926 05/16/2001 HI 1.25 1 .3 M 05/10/2001 This patient received DTaP / Hib on 05/09/01 in the AM. That night noted to be pulling at pant leg and restless. This AM noted a palm sized swelling, and dime sized area of erythema. On exam 10 cm area of swelling with 4 x 4 cm area of induration and erythema. Non tender. Warm. Recommended ice and PRN Tylenol. Y U 05/09/2001 05/10/2001 1 NONE PVT PVT Multivitamins and Fluoride. NONE Atopic dermatitis. 1
0169927 05/16/2001 PA 6 F 05/10/2001 Began 05/09/2001 with red spots and blisters, pruritic, temp of 99.8 (ear) (sibling had v-2 7/00 after Varivax 04/06/99). Y 07/19/1999 05/09/2001 660 NONE PVT PVT NONE NONE NONE 1
0169928 05/16/2001 NM 4.0 4 F 05/10/2001 The pt experienced a local reaction, complained of pain, swelling, redness and itching. Treated with Benadryl. Y Y 05/07/2001 05/08/2001 1 NONE PVT PUB NONE NONE NONE 1
0169929 05/16/2001 MI 15.0 15 M 05/10/2001 Fever, chills light headed, red swollen hot area at inj site. Y 05/03/2001 05/04/2001 1 NONE PUB UNK NONE NONE allergies 1
0169930 05/16/2001 FL 11.0 11 F The pt had a fever, first hot then cold, shaking, she had problems breathing. Her face was red (flushed) then pale and she would not eat. They symptoms lasted 2 days. The pt has had prior reactions. Y 04/26/2001 04/26/2001 0 OTH PUB NONE asthma, allergy to dust and animal dander unspecified~Hep B (no brand name)~2~11.00~Patient 1
0169931 05/16/2001 MN 56.0 56 F 05/09/2001 The pt called the clinic to report reddened area below injection site, no pain, localized itching. Y U 05/02/2001 05/06/2001 4 PVT PVT Nortriptyline, Prempro NONE allergy to codeine 1
0169932 05/17/2001 KY 0.2 0 .2 M Death within 24 hours. (According to death certificate, undetermined cause and manner of death). Autopsy states cause of death as undetermined. Infant was found in bassinet in prone position. Y 11/15/2000 N 11/14/2000 PUB PUB To give Tylenol after shots for fever. Nasal congestion Bilateral Inguinal hernias 11/1/00 KY2001034 1
0169933 05/17/2001 NC 0.3 0 .3 M 05/16/2001 This patient was seen for a well child check on 05/15/01. First office visit since birth. No previous immunizations. Received DTaP, IPV, HIB, Prevnar, and Hep B. The patient was found dead in the crib 05/16/01 in the AM. Autopsy shows congestion in lungs. A cause of death could not be determined. Petechial hemorrhages were found on several serosal surfaces raising the possibility of SIDS but suffocation by overlying cannot be excluded. Y 05/16/2001 N 05/15/2001 05/16/2001 1 NONE PVT PUB NONE NONE NONE 1
0169934 05/17/2001 TX 51.0 51 M 05/15/2001 This patient had extreme dizziness, light headedness, tightness in the chest, shortness of breath, aching muscles in his upper extremities, temp of 103.8. To the ER by ambulance. He was given Steroid tab and steroid prescription for 3 days. Chest x-ray & EKG. Y Y Y 05/10/2001 05/10/2001 0 Chest X-Ray, EKG. OTH OTH NONE Allergic to dust and mold. Hypertension, herniated disc. No birth defects. 1
0169935 05/17/2001 CA 1.25 1 .2 F 04/20/2001 This is a 14 month old female who was in a state of good health until approx. 4 days ago. A week prior, the child had an MMR shot and had been started on Amoxicillin, at the time, for presumed otitis media. The pt had been on Amoxicillin when she developed a fever, 4 days ago. The pt was treated with Tylenol and she has had persistent fever off and on since then. This morning, mom noticed that she had a red rash over her face and subsequently, noted a rash on the rest of the body as well. The pt was taker to ER, where she was noted to be febrile and had a maculopapular generalized rash. There was no neck stiffness and the pt was hemo-dynamically stable. Oxygen sats were 92% in 1 liter nasal cannula O2. Temperature was 104.2F. The pt was given a dose of Cefotaxime IV and transferred to another hospital for further management. The child has been listless all day. HR-144; Resp-26. On exam, throat appears slightly congested. Chest has occasional respiratory rhonchi. The dx is most consistent with a viral exanthem. Will observe closely in the ICU, IV Cefotaxime (pending culture results), symptomatic management of bronchospasm and coughing and if the child remains listless over the next several hours, will consider doing a lumbar puncture. Y 6 Y 03/08/1995 03/18/1995 10 PVT PUB Amoxicillin Otitis Media NONE 1
0169936 05/17/2001 KY 1.3 1 .4 M 05/15/2001 Severe local reaction, from should to elbows. Mother said, it was swollen, red and hot to touch on left arm. Hospitalized overnight per doctor. Y 1 Y 05/01/2001 05/02/2001 1 UNK UNK NONE NONE KY2001032 1
0169941 05/17/2001 NY 11.0 11 M 11/29/2001 This report describes food hypersensitivity in an 11 year old male who received Hep-B vaccine recombinant (Engerix-B). The reporter denied allergies and medical history. The pt took diphenhydramine hydrochloride (Benadryl) and fexofenadine hydrochloride (Allegra). On 9/26/00, the pt received his 1st dose of Engerix-B and 1 hours later, he experienced "food hypersensitivity" in the form of "tight throat" which later disappeared. No treatment was given. Reportedly, over the course of the next 2 weeks, the pt erupted into hives with some swelling of the lips, after eating foods to which he had never before been allergic. Additionally, he experienced headache and stomach ache whenever hives erupted. The pt was hospitalized. The reporter believed that these adverse events are related to Engerix-B. As of 5/4/01, the outcome of the events was ongoing. The pt was under the care of a pediatrician and an allergist. The vaccinee's mother refused to have the 2nd dose of Engerix-B administered. F/U has been partially verified by a physician. The pt was allergic to Ceclor and was according to the pediatrician was otherwise healthy. There were not concurrent medications. The pediatrician indicated that tightness of the throat occurred on 9/25/00, and resolved that day, He began to experience pruritis on 9/29/00, at that time his mother reported that. The pediatrician confirmed that hives began in 10/00, but did not confirm the headache, stomach ache, swelling of the lips or the dx of food hypersensitivity. The pediatrician reported that the pt experienced edema of the hands and feet. beginning on 10/30/00. The pt's mother reported that he was hospitalized this was not confirmed by the pediatrician. The following drugs were used to treat the hives and pruritis, fexofenadine hydrochloride (Allerga) from 10/31/00 to 11/00, diphenhydramine hydrochloride (benadryl) orally starting 11/00, cetirizine hydrochloride started 1/4/01, cimetidine twice daily started 5/01, montelukast sodium started 5/01. On 8/7/01, the pediatrician indicated that the tightness of throat was mild in intensity and had resolved. The pruritus, hives and edema of the hands and feet were moderate in intensity and ongoing. The pediatrician considered these events to be possibly related to Engerix-B administration. The pediatricain confirmed that the immunization series was discontinued. The pt was evaluated by a 2nd allergist on 3/28/01. At the time of the evaluation, the pt was taking Zyrtec daily. The allergist noed that after receiving Engerix-B, the pt returned from school and said I wish I hadn't had that shoe, it made my throat feel tight and very uncomfortable. The allergist wrote, this apparently disappeared in hrs or less. Over the following 2 wks he complained that his ankles and feet itched. This info was obtained in retrospect. Two weeks to the day after the vaccine administration he began to develop urticaria. He has had urticaria and angioedema since waxing and waning... The urticaria was raised, irregular in size, non blistered, not hemorhagic, and markedly pruritis. The angioedema was confined to the lips and on several occasions apparently to the hands and feet, this needs clarification. At on time there was visible tongue swelling. Maximum symptoms were in the months of Oct, Nov and early Dec. treatment: emergency room visit in nov., 4 months ago, given andIV injection of steroids. He then had a eriod of 2 weeks without symptoms. Symptoms tended to be present at night.worked up by (a different allergist). skin test for food said to be neg. The pt is otherwise well. He has had no difficulty with his medications. The mother questions whether benadryl works. She is convinced that there is a correlation between his change in immune system and the onset of uticaria. Family history: the mother is allergic, Physican exam: neg, Inpression: chronic urticaria, idiopathic, possibly related to hepatitis B vaccine.The allergist prescribed Zyretec daly and cimetidine twice daily. The pt was seen by the 2nd allergist on 4/17/01. He wrote the pt is doing extremely well. Now asymptomatic. It was noted that his pt has a protective titer of 19. The pt wa seen again by the 2nd allergist on 5/9/01. His medications included zyrtec, cimetidine, and epinephrine (epiPen) as needed. Teh allergist wrote, His symptoms have waxed and waned. initiall he did well with the zyrtec, but he has had breakthrough and despite an increase in medication. He continues to have symptoms all days. his rash is basically the same, waxing and waning. Pruritus is very well controlled ... workup to date has been negative. including cbc, ana liver function test, and compliment. a TSH is awaited his hepatitis B level is 19 which is high. Note he has had no respiratory problems. The allergist prescribed zyrec, cimetidine and singulair daily. The 2nd allergist saw the pt on 7/10/01 and wrote his chronic urticaria persists. The pt has symptoms almost all days, usually mild scattered on his trunk, non pruritic. Within the last 2 wks he has had a fairly severe episode with generalized urticaria. He may have had a little throat discomfot. The urticaria lasted for about 16 hrs. He was given benadryl backup and the itching quickly disappeared ...physical exam skin a few scattered lesions, raised on trunk, probably 10 in all. Lab work still showed little question of a slightly elevated T3. The allergist prescribed same meds as before. F/U 9/18/01 the most recent info was rec'd from the 2nd allergist. He reported tha the pt began to experience vague throat symptoms and pruritus on 9/26/00, and chronic urticaria began 10/10/00. He wrote, patient has chronic urticaria which has required careful manipulation to control. He is now reasonably controlled on zyrtec 25mg,singulair 10mg, and cimetidine 150mg, He has very mild hives daily. Pt doing well. He indiated that the chronic urticaria is possibly related to Engerix-B vaccine. The most recent info was received from the vaccinee's mother on 11/16/2001. At that time, the vaccinee was reportedly experiencing hives and swelling of his hands and feet daily. The events were being treated with Zyrtec, cimetidine and Singulair. Y Y N 09/26/2000 09/26/2000 0 CBC, F/U 10/11/00 rheumatoid factor,CBC,ESR,C3 and C4 ANA were all within normal limits. Unspecified thyroid tests performed on 7/5/01 were within normal limits.skin test-negative. blood test (NOS) neg. hepatitis B level was 19, which is high.HBs was positive and anti HBc was negative. CBC, ESR,C3 and C4 ANA titer, and RF measured 10/11/00 were within normal limits. Unspecified LFT's, CBC, and ESR measured on 3/21/01 were within normal limits. Unspecified thyroid tests performed on 7/5/01 were within normal limits. PUB PUB Benadryl and Allegra NONE F/U allergic to Ceclor 20000323341 1
0169951 05/17/2001 NC 1.25 1 .3 F 04/25/2001 This infant had a single vaccine administered on 04/23/00 to the left thigh. The next morning the parents noticed a red area around the injection site, it got bigger, and redder through the day. On 04/25/01, 14 x 11 cm area of erythema and resolving indurations; the was afebrile and happy. Y 04/23/2001 04/24/2001 1 NONE PVT PUB NONE NONE Had chronic otitis media, PE tubes placed on 03/30/01. NC01049 1
0169952 05/17/2001 VA 5.0 5 M 05/09/2001 This child had a fever of 102 F, and vomiting within 24 hours. Follow up call on 05/11/01, 3 days after immunization "all better". Y Y 05/08/2001 05/09/2001 1 NONE PVT PVT NONE NONE 1
0169953 05/17/2001 VA 1.0 1 .0 M 05/14/2001 This infant had a papular rash on his face, trunk, and extremities. U 04/30/2001 05/12/2001 12 NONE PVT PVT NONE NONE NONE 1
0169955 05/17/2001 MO 20.0 20 F 05/11/2001 "knot" on arm at site of injection, rash on arms and both legs, nausea, dizziness and light-headed. U 05/10/2001 05/10/2001 0 PUB UNK 1
0169956 05/17/2001 AR 6.0 4 F 05/15/2001 History of varicella within 1 year of age per mom. Varivax given by HD on 8/3/99 and MD confirmed case of varicella on 4/28/01. Y 08/03/1999 04/28/2001 634 NONE PUB PUB NONE 1
0169957 05/17/2001 CO 36.0 36 F 04/10/2001 Began having mid to lower back discomfort on 4/7/01 about 14:00. Continued with joint (knee and right hip) and general muscle aches. On 4/10/01 about 12:00, noted rash that was flat and pint to red on face and neck. Temperature was 99.5F. On 4/11/01, rash to arms and hands (non-palmer surface) and temperature was 100F. On 4/12/01, rash also on chest and back. Noted swollen glands behind ears and back of neck on right side more than left side. On 4/12/01, states feeling some better today, but "itchy". Some pain in right ear today. Y U 03/30/2001 04/07/2001 8 PUB PUB PPD skin test done on 3/27/01 and read on 3/30/01 as negative; Zinc; B Vitamins; Tylenol; Vitamin E; Antioxidant multi "Salopay" Protector Nutrient "Cold" Multiple Sclerosis history since 1993; Allergy to mold and fungi MS symptoms~Hep B (no brand name)~~35.00~In Patient CO01007 1
0169958 05/17/2001 NV 44.0 44 F 05/09/2001 Flu-like symptoms. My arm was bruised and swollen and I missed 2 days of work. Y 04/05/2001 04/06/2001 1 PUB PVT NONE NONE NONE 1
0169959 05/17/2001 MN 1.25 1 .3 M 05/09/2001 Would be considered "side effect" and not significant adverse event. Child received DTAP vaccine in left upper thigh. Within 18 hours, developed 6cm X 8cm area of redness/swelling. Was seen 36 hours, post vax, and noted to have local reaction, no cellulitis or "urticarial" type reaction. No other sequela noted. Y Y 05/07/2001 05/08/2001 1 NONE PVT OTH NONE NONE NONE 1
0169960 05/17/2001 WA 4.0 4 M 05/09/2001 Redness, induration, warmth in left deltoid area, 1 day, post vax. Suspect reaction to Diphtheria component. Symptomatic treatment and empiric treatment for cellulitis. Y U 05/08/2001 05/09/2001 1 NONE PVT PUB NONE NONE NONE 1
0169961 05/17/2001 VA 5.0 4 M 05/09/2001 Swollen left upper leg/thigh 38cm; right leg 31cm. Reaction to DTAP. R/o cellulitis. Pt was afebrile. Treated with Rocephin, 1 gram, right thigh, in office. Sent to ER the same afternoon. Right thigh, parents claims, is increased in swelling. Y U 05/08/2001 05/08/2001 0 PVT PUB NONE NONE RAD; GERD; Recurrent OM 1
0169962 05/17/2001 GA 4.0 4 M 05/07/2001 Left arm, red and swollen at (DTAP) injection. Y Y 03/13/2001 03/15/2001 2 UNK UNK NONE 1
0169963 05/17/2001 CA 4.0 4 M 05/07/2001 Local erythema and induration at injection site involving 2/3 of right lateral thigh around DTAP injection. Treated on 4/26/01 by Family NP with Augmentin. No fever or other systemic symptoms. Y Y 04/23/2001 04/25/2001 2 NONE PVT PVT NONE NONE NONE ~DTaP (no brand name)~5~4.60~In Sibling 1
0169964 05/17/2001 MI 5.0 5 M 05/10/2001 Very noticeable pale pallor; onset about 5 minutes, post vax, resolved in 1 hour. Able to talk, walk, normal pulse and BP. Vomited a small amount of emesis, post vax. Y Y 05/10/2001 05/10/2001 0 NONE PVT PVT NONE NONE NONE 1
0169965 05/17/2001 MI 20.0 20 F 04/23/2001 Reported "small knot" and inflammation now at injection site on left arm. Has noted "knot" since injection. Inflammation for the past 3 days. Area at measures 8mm. Y 03/12/2001 03/12/2001 0 PVT PVT NONE 1
0169966 05/17/2001 CA 11.0 11 M 05/07/2001 Varicella vaccine received on 4/4/01. Developed red, papular rash, no vesicles. Brother developed chickenpox rash on 4/16/01 and 2nd brother also developed chickenpox. Y Y 04/04/2001 04/10/2001 6 NONE PUB PUB NONE NONE NONE 1
0169967 05/17/2001 PA 20.0 U Soreness in the arm (left arm where received shot); deep muscular pain; half of body went numb (left side); left arm turned purple; splotchy coloring in hands; chest pains and tightness; hives; swelling in lips and cheeks and a migraine. Y UNK OTH NONE NONE Bee stings and food allergies Turned red and spot hardened~Measles + Mumps + Rubella (no brand name)~~1.50~In Patient 1
0169968 05/17/2001 KY 1.0 1 .0 M 05/11/2001 Took varicella vaccine on 4/30/01. Broke out with varicella rash on 5/10/01. (Blister rash over head, trunk, face and extremities). Y 04/30/2001 05/10/2001 10 NONE PVT PUB Reglan; Pepcid NONE Premature; S/P tracheoesophageal fistula; GERD KY2001033 1
0169969 05/17/2001 NV 23.0 23 F 04/17/2001 Within hours developed fever, dizziness, itchy and developed hives on legs and ankles, small amount on torso. Then developed trouble breathing and heart was racing. Client went to Urgent Care for evaluation. Was given epinephrine injection and a prescription. Was off work for 2 days. Y U 04/16/2001 04/16/2001 0 NONE PUB PVT Birth control pills NONE NONE 1
0169970 05/17/2001 NV 69.0 61 F 04/20/2001 Pt went to Urgent Care with complaints of swollen eyes, slight hives, headache, earache, weakness and rapid heart beat. Pt states, she was given Kenalog and "another shot" to combat reaction"; also had face swelling, vomiting and diarrhea. Pt took OTC Benadryl before going to MD. Y Y 04/10/2001 04/10/2001 0 NONE PUB PVT Caposide, Loricet, Zoloft, Synthroid, Ambien, Zyrtec, Soma NONE PCN and sulfa allergies, High BP, Asthma 1
0169971 05/17/2001 MD 3.0 2 .7 F 04/26/2001 Seizure, 1 week, post vax, lasting about 30-40 seconds. Eyes rolled back, fell unconscious, mild shaking of limbs. Very fatigued for several hours after seizure. On 4/28/01, had 2nd seizure about 30-40 seconds long and fell unconscious, eyes did not roll back and mild stiffness of extremities. Not yet recovered. Y N 04/03/2001 04/10/2001 7 EEG-neg; Neurological exam and blood work was normal. PUB PUB Infection in eye NONE 1
0169972 05/17/2001 IL 34.0 34 F 04/06/2001 Rash on lower arms and lower legs the day after injection X 5 days. 2 days, post vax, knees and elbows stiff X 1 1/2 days. On the 3rd day, post vax, fingers, ankles and feet swollen which lasted a couple of days. Notified MD. Pt refused treatment of cortisone. Took Tylenol for aching. No symptoms after 1 week. Y 04/03/2001 04/04/2001 1 PUB PVT NONE NONE Exposure to mono (son has) 1
0169973 05/17/2001 CT 4.0 4 M 04/27/2001 Swelling, erythema, warmth from elbow to shoulder. Y Y 04/25/2001 04/26/2001 1 NONE PVT PVT NONE NONE 1
0169974 05/17/2001 CA 49.0 49 F 04/20/2001 Feverish, weakness, significant generalized myalgias, light-headedness. Probable fever X 1-2 days. U 04/18/2001 04/18/2001 0 PVT PVT NONE PCN allergy 1
0169975 05/17/2001 NC 1.0 1 .0 M 04/27/2001 Mother called HD on 4/27/01 to report that child had a reaction to MMR given on 4/4/01. She states she took child to MD who was initially doubtful that symptoms were from vaccine. Symptoms of temperature of 104F X 4 days and poor appetite with weight loss during event (small amount of 2 lbs). Onset of symptoms was on 4/10/01. Y Y 04/04/2001 04/10/2001 6 CBC; Blood culture PUB PUB NONE NONE NONE 1
0169976 05/17/2001 KY 11.0 10 M 04/24/2001 The pt received Hep B on 4/23/01. Mother states the pt woke the next morning and was having trouble breathing and chest hurt. He thought he was dreaming. He also complained of chin hurting. He thought he may have asthma like some one else he knows. The pt's face turned pale and then flushed. He also complained of a stomach ache. Y Y 04/23/2001 04/24/2001 1 PUB PUB Tegretal, Mysoline NONE hx of CVA, epilepsy 1
0169977 05/17/2001 NE 49.0 49 F 03/20/2001 The pt experienced numbness, red rash, tingling the afternoon of the vax. Y 02/19/2001 02/20/2001 1 NONE OTH UNK NONE NONE 1
0169978 05/17/2001 IL 5.0 5 F 05/02/2001 On 5/2/01 the pt woke with hives to injection site and both legs. No itching, no restlessness, afebrile, no dyspnea. Not at 9:20 has urticaria to her back, hands, arms, wrists as reported by mother and pediatrician. No treatment given at this time. Y U 04/30/2001 05/02/2001 2 NONE PUB PUB environmental allergies, asthma 1
0169979 05/17/2001 NJ 4.0 4 M 04/25/2001 The pt experienced redness, swelling and pain at the site of injection. Y 04/23/2001 04/25/2001 2 PVT UNK NONE NONE 1
0169980 05/17/2001 AZ 1.3 1 .3 F 05/11/2001 2-3 days post vax the pt experienced swelling of the left thigh accompanied by a fever of 103+. 05/08/2001 05/11/2001 3 NONE PVT PVT NONE NONE NONE 1
0169981 05/17/2001 VA 0.08 0 .0 F A 2 week old female received Prevnar at an age less than recommended by US package insert. This report was a received on the day of immunization; no adverse event had occurred at that time. No adverse experience had occurred after 2 weeks post vax. Y 04/02/2001 04/02/2001 0 UNK PVT OTH NONE UNK UNK HQ9249104APR2001 1
0169982 05/17/2001 GA 0.3 0 .4 M 05/10/2001 Pt experienced swelling, redness, fever and hardening of left thigh. Pt was treated with antibiotic therapy. Y 05/08/2001 05/10/2001 2 PVT PVT NONE 1
0169983 05/17/2001 GA 1.8 1 .9 M 05/10/2001 Pt experienced swelling, redness, warmth and hardening of the thigh; cellulitis. Put on omnicef. Pt treated with antibiotic therapy. Y 05/07/2001 05/09/2001 2 PVT PVT NONE NONE NONE 1
0169984 05/17/2001 VA 1.0 1 .0 M 05/04/2001 Within 48 hours post vax, the pt began to shake his head violently from side to side and jerk forward uncontrollably. Episodes lasted less than a minute and occurred many times a day for approximately 2.5 weeks before gradually subsiding. Pt also experienced a mild fever and slept restlessly during this time. In addition the pt had swollen lymph nodes, especially in the groin area. The swelling was quite noticeable 2 weeks post vax. Y Y 01/23/2001 01/25/2001 2 EEG Negative (05/09/2001) PVT PVT NONE NONE NONE 1
0169985 05/17/2001 NJ 4.0 4 M 04/25/2001 Pt experienced swelling and redness at injection site. Y Y 04/23/2001 04/25/2001 2 PVT UNK NONE NONE 1
0169987 05/17/2001 MA 1.0 1 .0 M 05/01/2001 On 4/26 with 7-9 MP erythematous lesions. A few are vesicular and 2 with crusting. No fever, slight runny nose. No other complaints except a dry rough patch of skin on scrotum. All resolved 5 days later. Y 04/10/2001 04/24/2001 14 NONE PUB PUB NONE allergy to egg, milk protein 1
0169988 05/17/2001 OH 1.5 1 .5 M 04/21/2001 The pt experienced a seizure lasting 5 minutes one day post vax. Temperature in ER was 101. Y Y 03/09/2001 03/10/2001 1 EEG PVT UNK Zithromax congestion previous febrile seizures 4 separate times 1
0169989 05/17/2001 PA 1.0 1 .1 M 04/26/2001 The pt developed a fever on 4/25/01 through 4/26/01. The pt was drowsy also. The temp was 103.4 in the office. Y U 04/23/2001 04/25/2001 2 PUB PUB 1
0169990 05/17/2001 MD 22.0 22 F The pt experienced a large local reaction starting immediately after the vax lasting 3 weeks. The next morning (24 hours later) the pt developed generalized hives, swelling, and itching which lasted 48 hours. Y Y 05/08/2000 05/08/2000 0 MIL UNK NONE allergic rhinitis 1
0169943 05/18/2001 CA 0.3 0 .4 M 04/25/2001 Infant died in his sleep. Infant found unresponsive. Autopsy states cause of death as undetermined. Interstitial pneumonitis was a contributing factor in the death. Also noted were subdural neomembranes. Y 04/25/2001 N 04/24/2001 04/25/2001 1 PVT PUB NONE NONE NONE CA010049 1
0169944 05/18/2001 TX M 05/29/2001 Information has been received from a pharmacist concerning a male who was hospitalized and had a splenectomy due to trauma in early April 2001. On April 07, 2001, he received the 1st dose of Pneumococcal vaccine 23 polyvalent, 2nd dose on an unspecified date before 05/04/01, the patient's oxygen saturation levels began to decrease and he was placed on a ventilator. Additional info has been requested. After the fourth dose, the pt developed a rash on his upper body and at the same time his oxygen saturation levels began to decrease. he was transferred to the intensive care unit and was placed on a ventilator. The pharmacist felt that it was unknown if the rash was associated with the excessive number of doses of pneumococcal vaccine as an overdose an allergic reaction or if it was coincidental that it occurred after the fourth dose. On 05/17/2001, th ept remained hospitalized and it was unknown if the pt was still on the ventilator. Additional info has been requested. Y Y U 05/05/2001 05/05/2001 0 Arterial Blood O2 05/04/01 - decreased. OTH OTH UNK Splenectomy. trauma. WAES01050742 1
0169947 05/18/2001 LA 1.3 1 .3 M 05/16/2001 This child spiked a temp approximately 1 week later. He became more hyperactive, ceased taking daily naps, between 16 months and 18 months of age. Severe ADHD w developmental delay. Y N 02/26/1997 03/05/1997 7 Rubeola Ab IgG-pos; Mumps E1A IgG-pos; Rubeola-pos 3.68 ISR "Backed Up" in storage. PUB PVT NONE NONE NONE 1
0169949 05/18/2001 MI 1.5 1 .5 M 05/16/2001 A mother reported that her son (now 13 years of age) received doses of Orimune, Tri-Immunol and HIB (Coww) vaccines on 4/20/89, when he was 18 months old. She indicated that her son "immediately" developed a fever, loss of speech and loss of balance. He was subsequently dx'd with autism. She indicated that her son was born "gifted" and was walking at 6 months of age. Post vax, he needed speech therapy to relearn words that he knew prior to immunization. He is presently receiving chelation therapy to remove mercury from his system and, according to his mother, he has made great progress. She also reported that her son developed redness at the Tri-Immunol site. Autism was considered "Medically Important". F/U 7/3/01 no updated info rec'd. U 04/20/1989 04/20/1989 0 UNK OTH OTH NONE UNK UNK HQ0772411MAY2001 1
0169950 05/18/2001 IL 2.0 2 .7 M 05/03/2001 On 5/2/01 PM, red area around injection site (4" around). At 03:00 AM, awoke complaining of pain to left leg and it was still red. Temperature was 99.6F. On 5/3/01 at 09:00, went to health dept with left leg very swollen, red, hot to touch, discomfort to touch, blue to purple color (area of injection) and skin felt thickened. Referred to MD. Dx'd with cellulitis. Temperature of 99F. Medications given were Omnicef 125mg 5ml (2 tsp) daily x 6 days therapy; prednisolone 150mg 1/1 tsp twice a day x 5 days. On 5/4/01, improvement of 25% or more, less swelling and red coloring was lightened. On 5/7/01, slight purple color about nickel-sized, no pain and no swelling. No fever; almost gone. Information from grandmother. Y Y 05/01/2001 05/02/2001 1 NONE PUB PUB TB skin test, Tubersol/Aventis/C0630AA/ID/LFA NONE NONE IL01013 1
0169991 05/18/2001 MA 0.2 0 .2 M 05/14/2001 None- This patient needs to have DTaP ASAP. Y 05/11/2001 05/11/2001 0 NONE PVT PUB NONE 1
0169992 05/18/2001 CA 1.9 1 .7 F 05/11/2001 This patient's left lateral thigh had a reddened area 3 inches x 3 inches; painful to touch. Y Y 04/26/2001 04/27/2001 1 PVT PVT PPD, 04/26/01. NONE NONE 1
0169993 05/18/2001 NC 1.0 0 .1 F 05/14/2000 This infant had a fever, and a blotchy rash all over her body. Y 05/04/2000 05/12/2000 8 PVT OTH 1
0169994 05/18/2001 CA 0.8 0 .8 M 05/08/2001 At 2:30 Pm, this infant had an IM PCV-7; at 6 :00 Pm he was vomiting, listlessness, fever, and irritable. On 05/02/01 at 2:45 AM, he had vomiting 6 - 7 times. The patient was directed to the ER. The patient was hydrated with pedialyte p.o. and given suppository to stop the vomiting and was released. Y Y 05/01/2001 05/02/2001 1 PUB PUB NONE NONE NONE CA010050 1
0169995 05/18/2001 NC 0.2 0 .2 F 05/14/2001 This patient came in for a routine well visit. Vaccines were given approximately 15 minutes later the child was still crying and her right leg was noted to be very swollen and red from the thigh area to near the top of the knee area. The patient was extremely fussy. Provider notified. Monitored the patient, no other signs and symptoms at this time. N 05/14/2001 05/14/2001 0 PVT OTH NONE NONE NONE 1
0169996 05/18/2001 CA 4.0 4 M 05/11/2001 This child's right arm was swollen with redness and warm to touch at the injection site (deltoid area). Y Y 04/27/2001 04/29/2001 2 PVT PVT PPD, 04/27/01. NONE NONE 1
0169997 05/18/2001 PA 1.0 1 .2 F 04/03/2001 On 04/01 this infant had a rash all over her body. She had a fever of 101 the day after her vaccination. Her face and neck proceeded to rest of her body, pinkish not in palms. Measle like rash consistent with vaccine. Y N 03/23/2001 04/01/2001 9 PVT PUB NONE NONE NONE PA0127 1
0169998 05/18/2001 PA 16.0 16 M 03/16/2001 This patient presented tot he office 48 hours after administration with a 7 cm edematous area on his right deltoid, the site was warm to touch. Temp Wnl 98.9. Complains of pain at the site. The patient is to return to the office in two weeks for a follow up. U 03/13/2001 03/15/2001 2 PUB PUB NONE PA0137 1
0169999 05/18/2001 PA 16.0 16 M 04/12/2001 Pneumovax recommended by MD at school physical exam. History of asthma. PPD also administered a the same time, approximately 3 PM on 04/11/01. By the evening the patient developed generalized itching, and hives, covering most of his body. Physician unavailable that evening. The patient was seen at neighboring clinic, where he was given Benadryl IM, then oral Benadryl every 4 - 6 hours. The hives were present on 04/12/01 in the AM,but reportedly resolving. Y Y 04/11/2001 04/11/2001 0 NONE PVT PVT PPD, lot # CO521AA, 04/11/01. Allegra, Nasocort AQ. NONE Asthma. PA0136 1
0170000 05/18/2001 PA 1.6 1 .6 F 04/04/2001 On 03/28/01, telephone call from mother states left leg red and swollen. CHN visited, left leg swollen down to and including the knee. The child playing and walking. Pedal pulse was present, good pulse to leg and the foot. Instructed mom to use ice and Tylenol. Call PMD if worse. Y 03/27/2001 03/28/2001 1 PUB PUB NONE NONE PA0135 1
0170001 05/18/2001 PA 2.0 2 .2 M 03/02/2001 T 2 -3 1 - 3 inch band of vesicles, no pain, lasted less than 4 weeks. Y Y 01/03/1997 11/18/2000 1415 NONE PVT PUB NONE NONE NONE PA0132 1
0170002 05/18/2001 PA 1.0 1 .0 M 03/12/2001 The pt experienced dermatome, 1-3 inch wide vesicles, limping and right otitis media. Y Y 11/23/1999 11/02/2000 345 NONE PVT PUB PA0131 1
0170003 05/18/2001 PA 6.0 6 M 03/19/2001 This child was swollen, inflammed, tissue (warm to touch), at the site of the DTaP and MMR vaccination (left deltoid). Rx: Augmentin. Y Y 03/16/2001 03/17/2001 1 NONE PUB PUB NONE NONE NONE PA0130 1
0170004 05/18/2001 PA 16.0 16 F 03/30/2001 This patient received a call on 03/29/01, from the patient's parent. The parent reports the patient had her menstrual period on 02/26/01. Received MMR on 02/12/01 pregnancy is confirmed at the present. Reviewed information - no known problems after receiving MMR. The mother had spoken with OB / Gyn also. Call was made to Merck to report incident. EDC 12/03/01. U 02/12/2001 NONE PUB UNK Ceclor & Keflex. NONE PA0123 1
0170005 05/18/2001 PA 10.0 9 M 03/21/2001 Mom states that after 1st Hep B series received, the child complained of leg pain and sick in stomach; lasted that night and the next day. In the past he had "growing pains" and felt coincidental. Gave 2nd series of Hep B, same thing occurred but much more worse. Severe leg pain, ankles to knees. The patient couldn't sleep all night, nauseated. It was worse the next day then it went away. None since. Y 10/24/2000 10/24/2000 0 PUB PUB NONE NONE NONE Leg pain and sick to stomach.~Hep B (no brand name)~1~9.00~In Patient PA0128 1
0170006 05/18/2001 CA 4.0 4 F 05/11/2001 The pt experienced right upper arm redness, swelling and warmth to the touch from shoulder to elbow per physicians report. Y U 04/26/2001 04/28/2001 2 PVT PVT NONE NONE NONE 1
0170007 05/18/2001 CA 45.0 55 F 05/03/2001 The pt contacted the health department to report the following: The pt developed a fever 10 days post vax varying in range from 99-102. Followed by a red maculo-papular rash all over with olive sized nodules behind ears, watery eyes, nose and joint pain. Y 04/11/2001 04/21/2001 10 NONE PUB PUB NONE NONE NONE CA010047 1
0170008 05/18/2001 OH 5.0 5 F 05/14/2001 This child had swelling and tenderness in her left arm it hurts to lift her arm, very painful redness. The patient instructed to take Tylenol and use warm compresses 15-20 minutes every 2 - 3 hours. Call if not better. U 05/07/2001 05/11/2001 4 NONE PVT PVT NONE NONE NONE 1
0170009 05/18/2001 ME 1.25 1 .3 F 05/14/2001 This infants left leg had swelling, redness, and heat. Tylenol and Benadryl. Y Y 05/09/2001 05/11/2001 2 NONE PVT PUB NONE NONE NONE 1
0170010 05/18/2001 WI 7.0 8 F 05/11/2001 This child had 5.5 x 4.5 cm warmth, red, and tender area of right deltoid; cellulitis. Treated with Cephalexin for 10 days. U 04/25/2001 05/06/2001 11 NONE PVT PVT NONE NONE NONE 1
0170011 05/18/2001 OH 5.0 5 F 05/14/2001 This child was given DTaP on 05/11/01 in the left upper thigh. A rash developed at the injection site on 05/13/01. Seen at the office on 05/14/01. 5 cm x 5 cm circular erythematous rash with central clearing, (+) warmth, (-) tenderness, (-) firmness, pruritic. Y 05/11/2001 05/13/2001 2 PVT PVT NONE NONE Allergic to Amoxicillin. 1
0170012 05/18/2001 NH 2.0 2 .4 M 05/15/2001 The pt experienced a 2 inch area of redness and is hot to the touch. Y Y 03/26/2001 03/27/2001 1 PVT PUB NONE NH0118 1
0170013 05/18/2001 CA 8.0 8 F 05/04/2001 The pt received vaccines on 5/3/01. According to mom the pt developed a rash on left arm. No swelling, no redness. Only five papular rash extending 2-3" on left arm. Y 05/03/2001 05/04/2001 1 NONE PVT UNK NONE NONE NONE 1
0170119 05/18/2001 AZ 12.0 12 F 05/16/2001 The mother called to say the child had a "kinda" seizure. Right arm had jerking movements. Drooling and drooping of mouth. Unresponsive for a few seconds. No fever noted. Y 05/08/2001 05/14/2001 6 PUB PUB NONE NONE AZ0018 1
0170014 05/21/2001 LA 0.08 M 05/15/2001 Information has been received concerning fraternal twins that had the same shots on the same day. One child suffered ear infections and displayed speech and behavior regressing and the other did not. The only difference in their medical histories was that the regressed child had the hepatitis B vaccine (manufacture unknown) at 1 month of age and his twin sister had the hepatitis B vaccine (manufacture unknown) at 6 months of age. Upon internal review, behavioral disturbance and speech disorder were considered to be "Other Medical Events". No further information was reported. U OTH OTH UNK UNK WAES01051033 1
0170015 05/21/2001 FL 57.0 57 F 08/16/2001 A 57 year old female reported that she received Flu-Shield ('00-'01 formula) on 11/29/00. On 11/30/00, she experienced pain and numbness in her right leg and foot. She was seen by her physician "who was more concerned about her elevated blood pressure." On 12/20/00, the pain reportedly intensified and had spread to her left leg. She was admitted to the hospital where a dx of vasculitis was made. She was treated with cyclophosphamide and was released. On 1/25/01, she developed kidney failure, dehydration and clots and was re-admitted to the hospital. She was told that a virus attacked her T-cells. She underwent a cardiac catheterization to look for clots. She was discharged; however, as of 5/14/01, she was still experiencing pain and numbness in both of her legs. Following changes were made: no other vaccines were given within 4 weeks, this event was considered life-threatening. Follow-up info received from the physician on 08/15/2001, indicated that the pt was diagnosed with mononeuritis multiplex, livedo reticularis, and foot drop. Test results revealed an elevated erythrocyte sedimentation rate, elevated C-reactive protein, and a positive p-antineutrophil cytoplasmic antibody. Y Y Y N 11/29/2000 11/30/2000 1 Erythrocyte sedimentation rate-increased; C-reactive protein-increased; positive p-antineutrophil cytoplasmic antibody PVT OTH Dyazide, Tenormin NONE UNK HQ0890815MAY2001 1
0170016 05/21/2001 WA 2.0 1 1 M 05/16/2001 A parent reported that her 24 month old son received an injection of Prevnar on 5/9/01. On 5/10/01, at approx. 02:00 AM, he awoke with "severe" stomach cramps. At 09:00 AM, he developed a temperature of 103F and was given Tylenol. At 11:00 AM, he experienced lethargy and a seizure. Between 13:00 PM and 13:15 PM, he experienced 2 additional seizures. The reporter described the seizures as "jerks". The child's physician was notified and indicated that these were febrile seizures. The child was seen by the physician and blood work allegedly showed "low" iron and "low" RBC's. The child was hospitalized on 5/11/01; his mother indicated that her son was dx'd with "erythroblastemia". He received a transfusion and later released to home. On 5/14/01, the mother reported that her son developed "severe" diarrhea. No further information was available at the date of this report. F/U info received from the physician on 10/16/01, provided office and hospital medical records. On 5/10/01, the physician noted that the child was very fussy and lethargic and had a fever of 101.4F. During the exam, while the mother was holding the child, he experienced 3 separate episodes where his body jerked about 3 times each, followed by some crying. During these episodes, the child remained awake and did not lose consciousness. The physician noted that the child was pale and referred the child to the ER for a hematologic evaluation. The physician suspected a viral illness, possible febrile seizures and severe anemia. The following day, the child was transferred to a hospital. A primary dx of severe anemia, probable transient erythroblastopenia of childhood (TEC) was made. Associated dxs included fever and convulsions. He was transfused with 1 pedipak of packed RBC's and if well tolerated, 3 additional pedipaks were planned. The child was discharged to home and scheduled to return to the center within 7 to 10 days for a repeat CBC. Y Y U 05/09/2001 05/10/2001 1 5/11/01-Red blood cell count-"low"; blood iron-"low" F/U labs: hemoglobin 5.7g/dl (low); hematocrit-16.0% (low); hypochromia, no fragments, no shift; WBC-6,4000/cumm; neutrophils 70%; lymphocytes 16.5%, and monocytes 10.8%; 5/10/01-blood glucose 125mg/dL (high); 5/10/01-blood culture-no growth in 5 days PVT OTH NONE NONE Torticollis HQ0888615MAY2001 1
0170017 05/21/2001 NJ 1.7 1 .7 M 05/31/2001 A nurse reported that a 20 month old male received his 2nd dose of Prevnar along with DTP and Poliomyelitis inactivated in December 2001. In April, 2001, he developed a fever and was taken to his pediatrician. Blood cultures were drawn and were positive for S. Pneumonia. Serotypes were not available on the date the report was submitted. Septicemia streptococcal was considered to be medically important. Follow up information received from vaccine provider on 05/15/01 provided the diagnosis of strep pneumococcal pneumoniae; the date of adverse event onset, as well as, the complete dates and lot numbers for each of the two Prevnar administrations. the reporter indicated that the patient recovered. Additional info from the reporter on 05/29/2001 provided the pt's name and date when the pt was hospitalized. The hospital laboratory could not provide a serotype. The pt remained recovered. Y Y Y Y 12/12/2000 04/27/2001 136 04/01-blood culture-positive for S. pneumococcal pneumonia OTH OTH NONE NONE UNK HQ0620208MAY2001 1
0170020 05/21/2001 OH 84.0 84 F 05/15/2001 Information has been received from a medical assistant concerning an 84 year old female with an allergy to sulfa and Codeine who on 04/25/01, was vaccinated with Pneumococcal vaccine 23 polyvalent. Concomitant therapy included Losartan Potassium (Cozaar) (MSD), furosemide (Lasix) and diltiazem hydrochloride (Dilacor XR). Subsequently in April or May 2001, the patient experienced swelling and redness at the injection site and cellulitis. The patient was treated with ceftriaxone sodium (Rocephin) IM for two days. Subsequently, the patient recovered from swelling at the injection site, redness at the injection site and cellulitis. Upon internal review cellulitis was determined to be an Other important Medical Event. Additional info has bee requested. Y Y 04/25/2001 05/01/2001 6 UNK UNK Dilacor XR; Lasix (furosemide); Cozaar Allergies to sulfa and codeine. WAES01050877 1
0170022 05/21/2001 NY 12.0 11 F 02/27/2002 Report 2001012009-1 describes chronic fatigue syndrome in a 12 year old female who participated in a Lyme disease vaccine clinical trial (study vaccine 215274, protocol 022, center 008, patient number 02212). This report was received spontaneously from the patient's father and has not been verified by the investigator or other health care professional. Concurrent conditions included asthma and allergy to Sulfa. Concurrent medications included unspecified inhalers. The patient received three injections of study vaccine on unspecified dates. No adverse experiences occurred following these three injections. The patient received a booster dose of study vaccine in approximately October 2000. The pt's fahter reported that approximately one month after receiving the booster, in November 2000, she reportedly experienced headache and fatigue, and developed a sinus infection with a sore throat. Approximately two months after receiving the booster, in December 2000, the patient's symptoms reportedly worsened. The headaches became "crushing" and the child reportedly experienced joint ache in her knees, elbows, and spine; the aches would move from joint to joint. Her joints were not red, swollen, or warm. The joint aches were not documented by a physician, and no fluid was aspirated from any other joints. The child also experienced muscle pains "all over", and "brain fog". In January or February 2001, the child was seen by a physician. An unspecified test for Lyme disease was reportedly negative. No treatment was administered at that time. On an unspecified date, the child developed a yeast infection and was treated with Nystatin. The patient's father indicated that the yeast infection was possibly related to study vaccine. The patient's father reported that the child was seen on an unspecified date by the study investigator, who reportedly made a diagnosis of chronic fatigue syndrome. The child is currently being treated with Nystatin Acetaminophen w / Codeine (Tylenol #3), Amoxicillin (Amoxil), probenecid, trazodone (Desyrel), methylphenidate (Ritalin), and levothyroxine (Synthroid). As of 05/07/01, the sore throat had resolved. The headaches, joint aches, muscle pain, and "brain fog" persisted. The outcome of the sinus infection and yeast infection were not specified. The child sleeps 16 hours daily. She is unable to ambulate short distances without experiencing "pain and discomfort all over". She is not actively involved in sports or hobbies. Therefore, the chronic fatigue syndrome is considered incapacitating and this report is classified as serious. F/U additional info was rec'd from the investigator. other unspecified allergies, and intermittent sinus problems for which she was treated in the past with nasal steroid sprays, antihistamines, and decongestants. Family history is significant for chronic sinus problems in pt father. The pt was admitted to the hosp 5/21/01 with admitting dx of ataxia. The pt's chief complaint was weakness. The admitting physician stated that the pt was well until 8/00 when she became weak and developed headaches, she had opinion from pediatrics, infectious diseases and rheumatologly experts. Dx were not made.The investigator reported that as of 6/5/01, the sinusitis persisted. Sinusitis was the only serious adverse event reported by the investigator. Outcome of the events reported by the pt's father included the consultation notes of the 5/01 hospitalization were not provided F/U The pt's 2 siblings also participted in the Lyme disease vaccine trial, they are doing absolutely fine, but their mother withdrew her consent for them to complete the trial. a diagnosis of anemia was made. Pt was seen by neurologst 5/23/01, the pt reported diffuse weakness, arthralgia, myalgia, low grade fever, nausea, chronic headaches, and gait ataxia. symptoms began 8/00. On 02/14/2002, the investigator forwarded medical records from a physician specializing in "pediatric and adolescent medicine, Lyme disease." On 06/20/2001, E. burgdorferi IgG by immuneflourescence essay was 1.64. Peripheral smear of blood collected 06/25/2001 demonstrated "slight anisocytosis, slight poililocytosis, occasional ovalocytes, and slight hypochromia. Platelets appear adequate. The pathologist also noted "three ring-forms" of Babesia containing food vacucles. Cytoplasm of monocyte containing morule of human monocytic ehrlichia. Treatment and outcome of babesiosis and ehrlichiemis were not provided. The most recent info received on 02/14/2002, did not provide outcome of any of the reported events. Y Y 11 N 06/13/2000 05/21/2001 342 Lyme test-negative in January, 2001, MRI - normal, Western Blot equivocal with an IgG of 30 and 31 and and IgM of 32 and 31. The pt reports she has grown weaker. F/U 5/9/01 revealed lme titer of 7.65, potassium 5.3, chloride 107,carbon dioxide 15,anion gap of 20, alkaline phosphatase 113, total T3 90, and folate>20. On 5/25/01 RBC was 4020, hemaglobin was 11.2 with hemtocrit of 32.3%.5/26/01 total iron was 19 with 7% saturation. Pre-albumin was 15. stool specimens were collected on 5/23/01,5/24/01 and 5/30/01, no ova or parasites were seen. Many WBC were noted. One of the specimens was positive for Clostridium difficile toxin A. no enteric pathogens were isolated upon culturing the stool. Computed tonogram (CT) of the abdome with contrast was performed on 5/27/01. unremarkable CT scan of the abdomen and pelvis; Peripheral smear of blood collected 06/25/2001 demonstrated "slight anisocytosis, slight poililocytosis, occasional ovalocytes, and slight hypochromia. Platelets appear adequate. The pathologist also noted "three ring-forms" of Babesia containing food vacucles. Cytoplasm of monocyte containing morule of human monocytic ehrlichia. PVT PVT Inhalers (unspecified)cromolyn sodium (Intel),zoldipem (ambien), loratadine (claritin) and Prilosec. UNK Allergy to Sulfa. Asthma. 20010120091 1
0170027 05/21/2001 VA 0.5 0 .5 M 05/10/2001 The pt vomited and appeared apneic about 1 hour post vax. The rescue squad delivered bag/valve mask ventilation. In the ER the pt had normal Physical exam except the pt experienced somnolence. The pt returned to normal mental status in ER was admitted to hospital overnight. Y Y 1 Y 03/30/2001 03/30/2001 0 EEG-nml; CBC and Metabolic panel; Head CT-nml except slightly prominent ventricles PVT PUB cold 1
0170028 05/21/2001 TN 1.5 1 .5 F 05/15/2001 This patient received immunizations on the day prior to admission. On the day of admission she was taken to the ED in status epilepticus. She was being treated for epilepsy with Zonisamide and Klonopin. The father reports epilepsy began with the first DTP. Diagnosed with carbamazepine overdose. Y Y Y U 05/14/2001 05/15/2001 1 EEG-results pending PVT OTH Klonopin, Zanisemide NONE Epilepsy 1
0170029 05/21/2001 PA 0.75 0 .8 F 03/12/2001 The child developed bronchospastic cough approximately 45 minutes after immunization. On lung exam, she had diffuse wheezing which was not present on initial exam. She was treated with Prelone and given three Albuterol nebulizer treatments. After which she had minimal wheezing. Then approximately 2 hours later the patient developed persistent cough and diffuse wheezing on exam. Therefore was sent to the ER for further management. Y Y Y 1 Y 03/08/2001 03/08/2001 0 PVT PUB URI NONE PA0129 1
0170030 05/21/2001 CA 72.0 72 M 04/16/2001 This patient complained of swelling, dizziness, and subjective fever per mother. The patient went to the hospital and was admitted . Y 1 Y 04/09/2001 04/09/2001 0 PUB PUB Tylenol; TMC Cream for lesion,Atenelol, Benazepril, Lipitor, Lodapine, coumadin, HCTZ, Isordil NONE HTN, Valve replacement, CAD, Hypelipidemia CA010048 1
0170031 05/21/2001 PA 53.0 53 F 03/19/2001 The pt was diagnosed with chest and abdominal pain. Then went into Guillain Barre Syndrome. Y Y 30 Y Y 12/07/2000 12/31/2000 24 OTH PVT UNK UNK UNK PA0134 1
0170032 05/21/2001 WI 1.3 0 .8 M 05/09/2001 Redness and swelling noted by mom, the afternoon following DTAP injection. Area was approx. 2" in diameter. Spontaneously resolving now. By the next day, redness gone and swelling decreased. N 05/03/2001 05/03/2001 0 PUB PUB Tylenol given every 4 hours, post vax. NONE NONE 1
0170033 05/21/2001 ME 1.0 1 .0 F 05/10/2001 Fine, erythema, maculopapular rash all over body. Injection of the conjunctiva and profuse rhinorrhea. Y Y 05/03/2001 05/06/2001 3 CBC-suggestive of lymphocytosis PVT PUB 1
0170034 05/21/2001 VA 1.0 1 .0 M 05/08/2001 Hives on torso and arms which began approx. 8 hours, post vax. Did not appear to cause discomfort. No treatment. By morning, gone, except for a couple patches of redness. Y 03/28/2001 03/28/2001 0 PVT PVT NONE NONE 1
0170035 05/21/2001 FL 0.4 0 .5 F 05/09/2001 Vaccines given 5/8/01 afternoon. Pt slept all afternoon and night. On 5/9/01 AM, pt had several jerking movements of head, hands and feet for a few seconds duration with 10-15 minute intervals. Pt febrile. Y Y 05/08/2001 05/09/2001 1 CSF-wnl; U/A-wnl; CXR-wnl; WBC-25,000 PVT PUB Mild URI, afebrile NONE 1
0170036 05/21/2001 CA 4.0 4 M 05/17/2001 The pt had mild erythema, pain on palpitations. Injection was given on 5/15/01 and the pt was seen for reaction. The pt was prescribed Atarax, Keflex and Triamcinolone. U 05/15/2001 05/16/2001 1 ` PVT PVT PPD, Zyrtec, Ventalin chronic allergic rhinitis 1
0170037 05/21/2001 IL 0.4 0 .4 M 05/11/2001 Mother states child developed temperature > 102F. Rash noted on torso but resolved within 24 hours. Child was irritable for 1 week, post vax. No reaction from 1st set of shots. Y Y 03/08/2001 03/09/2001 1 PUB PUB NONE 1
0170038 05/21/2001 FL 24.0 F 05/11/2001 Intermittent fevers X 1 year. She states symptoms started after receiving anthrax vaccination. N MIL MIL NONE NONE Fever~Anthrax (Biothrax)~3~23.00~In Patient 1
0170039 05/21/2001 SC 50.0 50 F 05/05/2001 Within 10-12 hours, onset of diarrhea, tightness in throat, non-productive persistent cough, feeling of choking in base of throat, hot feeling in lungs, chest pains in upper left chest, laryngitis, anxiety, depression; treatment with prednisone, Diflucan, quaifenisen, codeine cough syrup, Ativan. At present, still have cough, diarrhea and anxiety. On 1/10/01 had yeast infection in mouth, throat and vocal cords; treated with Diflucan (3 rounds). On 5/8/01, had 12 day prednisone treatment begun with Diflucan in case of reoccurrence of yeast. Y N 12/04/2000 12/05/2000 1 Bronchoscopy on 4/2/01-no physical problem PVT PVT Albuterol, Flovent, Benadryl, Estradiol, Synthroid, vitamins NONE Asthma, Hypothyroidism, allergies to grasses, pollens, NSAIDS 1
0170040 05/21/2001 VA 38.0 38 F 04/27/2001 I have been breaking out in rashes on my arms, legs, neck, face and hands. My eyes swell and I have constant tightness on the left side of my chest since June, 2000. Y N 11/03/1999 06/01/2000 211 MIL MIL NONE NONE 1
0170041 05/21/2001 IL 4.0 4 M The pt experienced right thigh swelling of entire anterior thigh. with redness. Y 05/07/2001 05/09/2001 2 NONE PVT UNK NONE NONE NONE 1
0170042 05/21/2001 IL 1.6 1 .5 M 05/15/2001 Developed generalized urticaria, 6 days, post vax. Large urticarial wheal over left thigh injection site with central clearing. Resolved with Benadryl. Incidentally has been complaining of ear pain prior to reaction. Y Y 04/11/2001 04/17/2001 6 PVT PVT ? ear infection/ear pain NONE 1
0170043 05/21/2001 NJ 1.0 1 .1 F 05/02/2001 The pt experienced an elevated temp of 104, rash to entire body which started 7 days post vax. Went to the MD and Motrin was ordered. The parent was instructed to give child fluids and cool compresses to rash if continues. Y Y 02/28/2001 03/07/2001 7 NONE PUB OTH NONE NONE 1
0170044 05/21/2001 MA 1.6 1 .6 F 05/11/2001 Swelling and warmth to right thigh. No fever or erythema on 4/7/01. Resolved with warm compresses. Had fever of 104F and vomiting; onset 4/8/01 X 24 hours. Y Y 04/05/2001 04/07/2001 2 PVT PUB NONE NONE NONE 1
0170045 05/21/2001 WI 54.0 54 F 05/15/2001 Stepped on cactus about 2-3 hours before 1st shot. Had increased pain in foot. Saw MD and substance removed. TD and Ig given at that time. Two days, post vax, 2nd TD, felt "pinging" feeling in chest. Then developed muscle aches on right side that progressed to neck. Experienced tightening muscle spasms to neck. Seen in ER and given Valium and Toradol. Is to follow-up with neurologist. Y N 04/06/2001 04/15/2001 9 NONE UNK UNK Ig given IM on 3/4/01; 0 previously. Prednisone pack complete 2 days prior to 2nd shot; Prempro. NONE 11/00 had surgery to neck (disc removed and plate placed in neck). Unspecified reaction~Influenza (Seasonal) (no brand name)~~8.00~In Patient 1
0170046 05/21/2001 CA 4.0 4 M About 1 hour, post vax, Typhoid and Hep-A, pt had edema of face with dramatic improvement after starting Benadryl po every 6 hours per MD. Asymptomatic by 5/10/01 at 09:00. Patanol opth. drops ordered, 1 drop in each eye, every 12 hours X 1-2 weeks; Epi Pen Jr Rx given to use, prn. Y Y 05/07/2001 05/07/2001 0 No relevant lab data at this time. PVT PVT Claritin, Benadryl, Motrin, Patanol NONE 1
0170047 05/21/2001 TX 5.0 5 M 05/14/2001 A few minutes, post vax, pt collapsed to floor and from 5-7 seconds, eyes were rolled back. Body was stiff and he was not breathing. He then roused. He had a forming ecchymotic and swollen area on his forehead. Ice was applied to forehead. Mother declined anything else. Y 05/14/2001 05/14/2001 0 Mother declined. PUB PUB NONE NONE Mother says he does this with every vaccination. 1
0170048 05/21/2001 MD 1.0 0 .0 F 05/15/2001 Fever, rash, irritability, 9 days, post vax. Y 04/06/2001 04/15/2001 9 PVT PVT 1
0170049 05/21/2001 OR 3.0 3 F 04/30/2001 (?) hours, post vax, child had problems with breathing. Problem reported 7 months, post vax. Not seen by PCP for follow-up. Y 08/24/2000 08/24/2000 0 PUB PUB NONE NONE NONE OR200120 1
0170050 05/21/2001 OH 5.0 4 M 05/15/2001 Outbreak of chickenpox, spots on face, neck and leg. Advised to cut fingernails, apply Benadryl to spots and Aveeno Bath. U 09/11/1996 05/15/2001 1707 PVT PVT NONE NONE 1
0170051 05/21/2001 CA 1.75 1 .8 M 04/26/2001 Body rash X 2 days. No difficulty in breathing. U 04/24/2001 04/26/2001 2 OTH OTH 1
0170052 05/21/2001 FL 4.0 4 M 05/14/2001 Pt given vaccine on 5/10/01. On night of 5/11/01, started with fever, little cough, runny nose and rash on both arms and legs. Still with rash on 5/14/01. Went to ER on 5/12/01. Had negative throat culture. Y U 05/10/2001 05/11/2001 1 Throat culture-neg PVT PVT NONE Neurofibromatosis-genetic 1
0170053 05/21/2001 WA 5.0 5 F 05/11/2001 10cm X 12cm swelling, erythema and heat at left anterior thigh adjacent to DTAP injection. Also had a fever. Should do fine. Y U 05/08/2001 05/10/2001 2 PVT PVT NONE NONE NONE 1
0170054 05/21/2001 TX 4.0 4 F 05/11/2001 On 5/10/01, mother noticed redness and induration at injection site. Child said there was no pain, only slight itching. On 5/11/01, redness and induration on right arm below shoulder to above elbow. No crying or fever. U 05/09/2001 05/10/2001 1 PUB PUB NONE NONE NONE 1
0170055 05/21/2001 VA 5.0 5 M 05/04/2001 Had 1+ pitting edema on left deltoid area. Arm was red and swollen 3 X larger than the right arm. Symptoms lasted X 4 days. Saw MD on 4/20/01. No treatment recommended. Y Y 04/18/2001 04/19/2001 1 PUB PUB NONE NONE NONE 1
0170056 05/21/2001 MA 5.0 5 F 05/18/2001 Area of shot, red, swollen and warm to touch. 6cm diameter today. Mom reports was bigger yesterday. Given Benadryl. Y 05/16/2001 05/17/2001 1 PVT UNK Mantoux/LFA 1
0170057 05/21/2001 CA 11.0 11 F 05/08/2001 The pt felt dizzy, faint, was pale. After 15 minutes the pt felt better. Also drank water. Y 05/07/2001 05/07/2001 0 PVT PVT NONE NONE 1
0172279 05/21/2001 DE 0.34 0 .3 M 05/21/2001 The pt was seen on 5/7 with 3 day hx of a loose productive cough and marked nasal congestion. This was thought to be a URI. Cough persisted in spite of inhalation therapy and steroids. Pt was seen on 5/16 and started on Biaxin with improvement. Y 05/21/2001 Y N 05/02/2001 05/04/2001 2 Autopsy - pending PVT PUB Reglan, Zantac, Xopenex NONE laryngotracheomalacia, bronchomalacia, gastroesophageal reflux, atrioseptal defect, vascular ring 1
0170058 05/22/2001 NY 1.0 1 .1 F 05/13/2001 Information has been received from a physician concerning a 12 month old female who was vaccinated with MMRII and varicella virus vaccine live. Ten days later, the pt developed a fever and rash. The physician noted that under the microscope he can not determine what caused the rash. Follow-up from the physician indicated that he was the pathologist who had received the skin biopsy specimen of the rash from the pt's dermatologist. He received the specimen, 3 days prior to the pt's death. Additional information from the pt's pediatrician, indicated that the child received MMRII, varicella and Prevnar on 4/13/01 and on 4/25/01, the pt was brought into the office with a fever of 101F associated vomiting, lethargy, dehydration and a generalized rash that looked like erythema multiforme. Another physician was working with the physician that day and they both agreed that it looked like erythema multiforme. The parents were told to bring the pt back on 4/26/01 for a follow-up visit. On 4/26/01, the rash still appeared as erythema multiforme, however, it was not as generalized and was more discrete. The parents reported that the child was also on a Chinese herbal medicine and the baby sitter reported that the child had eaten a new kind of fish that night. The pediatrician referred the pt to a dermatologist and when he saw the pt, he reported that he had never seen anything like the rash that the pt presented with and he did a skin biopsy. The next day, the pediatrician called the pt's home to check her condition. The child's baby sitter reported that the child was doing fine, eating, drinking and the rash was getting better. On 4/27/01, the pediatrician called the pt's home again and wanted the child to come in to be seen, however, the family was reluctant because they reported the child was doing fine, the rash had faded and the child's fever was gone. On the night of 4/28/01, the family took the child to the ER. The ER physician called the pt's pediatrician and told her that the pt presented to the ER with fever, crying with no tears and dehydration and vomiting. The ER physicians were unable to get an IV line into the child, the child went into shock and arrested, with failure to revive. The family refused to autopsy. The cause of death on the death certificate was meningococcal meningitis. The pediatrician reported that the cause of death could not possibly be meningococcal meningitis because the blood cultures that she had done on the pt at the height of the rash on 4/25/01 were negative and the fever and rash had gone away without any prophylaxis treatment. The pt's father could not tell the pediatrician the name of the Chinese medication, only that it was herbal Chinese medication. The pediatrician reported that a piece of the skin biopsy was sent for PCR analysis and the pediatrician was unsure if this would be conclusive or not. The pediatrician also reported that there was no blood obtained for IgG or IgM titers. The pediatrician noted that she did not know the cause of death. The child's body was being taken to another country to be buried. Follow-up from another physician indicated that the pt had negative blood cultures taken in the PCP's office and he was not sure where the dx of meningococcal meningitis came from without further lab support. He was questioned as to whether the community where the child lived may need prophylaxis and from the description of the child's symptoms, he did not feel the symptoms were consistent with a meningococcal bacteria. The physician noted that the child looked septic on admission to the hospital and he wondered if the child was actually dehydrated. The physician was unsure if the child 1st respiratory or cardiac arrested, however, he did feel that it would be unusual for a child this age to 1st cardiac arrest. The physician confirmed that the child did eat a different type of fish and wondered if the child may have contracted a Vibrio infection from ingesting infected raw fish. Conflicting information from this physician indicated that the child was seen on 4/22/01 by the PCP and a maculopapular rash was dx'd as an atypical measles type rash. The child's rash then reportedly improved however on admission to the ER, the child reportedly had a florrid, "violatious" rash. The physician wondered about the child's immune status, since the child lived on a commune where group marriages occurred. The commune consisted of approx. 300-400 people. The physician noted that this was all just philosophical discussion since an autopsy was not performed and the cause of death will probably not be known. No further details were provided. Additional information received on 05/23/2001 indicated that PCR results from the parafin block extraction were negative for V2V. Additionally the specimen was concentrated down, in hopes of going further and making it more sensitive; however, it was still negative for V2V. The patient's physician was planning to have a PCR done for measles, as "atypical measles" was one of the clinical diagnoses for the pt. The physician reaffirmed that she did not believe the child's rash was varicella. The physician plans to have additional specimens sent for measles PCR. Additional info has been requested. Follow-up info has been received from a physician who stated that, according to the CDC, the skin tissue tested neg. for MMR. He also reported that the VZV was neg. Additional information has been requested.This is an amended report. The pt's age was changed from 12 months to 13 months. This is a corrected report as amended. Y 04/28/2001 Y N 04/13/2001 04/22/2001 9 Full blood work-up and blood cultures were negative; temperature 101F; CBC-nml except for a few extra bands. PCR and VZV analysis-neg; WBC-8.4 and 8.1; serum calcium-10.8 (high); albumin-4.4 (high); mean corpuscular hemoglobin concentration of 33.9 (high); LDH-541 (high); neutrophil ct-19%; hematology-14%; ESR-34; antistreptolysis O antigen test-5.0; skin biopsy-clusters of necrotic keratinocytes in the superficial epidermis and a small amt with also exocytosis of mononuclear cells and some extravascated erythrocytes and these features are difficult to interpret and is being tested for viran DNA PVT OTH Chinese herbs (unspecified) History of allergies and eczema; on 6/12/00, the pt had a hematoma on the forehead (CT Scan was nml) WAES01050031 1
0170066 05/22/2001 MI 3.0 2 .0 M 06/19/2001 Information has been received from a physician's office concerning a 3 year old male who on 5/5/97 (lot #10024 invalid) was vaccinated with MMRII. In 11/98, the pt was dx'd with autism. The pt's mother believed that the autism was "due to" vaccination with MMRII. Upon internal review, autism was determined to be an "Other Medical Event". On 4/5/99, (lot #0759 invalid) was vaccinated with a 2nd dose of MMRII. The pt had transferred to this practice. Additional information has been requested. The follow-up states on 07/07/1998 the pt was sent at a genetic clinic and had a genetic test done which was normal and a fragile X test was also normal. on 11/11/1998, a pediatric neurologist reported "that the pt appears to have autism." On 12/12/1998 another physician and psychologist reported that "the child was slow to progress, in the intermediate school district." The pt's mother believed that the autism was "due to" vaccination with MMR vaccine. Upon interal review, autism was determined to be an other medical event. On 04/05/1999 the pt was vaccinated with a second dose of MMR vaccine. The pt transferred to a different practice. Upon internal review, autism was determined to be an other medical event. No further info is expected. F/U states: vaccinated with MMRII, in the left thigh (lot 620094/1334D) (lot 619063/0228D-diluent vail); Hep-B (ENG2283A2) in the right thigh. On 7/798, the pt was seen at a genetic clinic and had a genetic test done which was normal and a fragile X test wasl also normal. In 11/98, the pt was dx'd with autism. On 11/11/98, a pediatric neurologist reported "that the pt appears to have autism". On 12/12/98, another physician and psychologist reported that "the child was slow to progress, in the Intermediate School District". The pt's mother believed that the autism was "due to" vaccination with MMRII. Upon internal review, autism was determined to be an "Other Important Medical Event". On 4/5/99, the pt was vaccinated with a 2nd dose of MMRII (lot 0759-invalid). The pt transferred to a different practice. F/U from the physician's office idicated that there were no reported adverse experiences and that suspected autism was considered to be a pre-existing condition. No further information is expected. Y U 05/05/1997 11/01/1998 545 7/7/98-genetic testing and fragile X-nml PVT PVT UNK nasal congestion; eczema; speech disorder (not talking) autism WAES01050688 1
0170067 05/22/2001 AZ 0.2 0 .2 M 05/18/2001 A healthcare professional reported that a 9 week old female received Prevnar, Comvax (MSD), IPV (Aventis Pasteur SA) and Tripedia (Aventis Pasteur Inc) on 5/11/01. The infant is a surviving twin, born prematurely at 29 weeks gestation. Concurrent conditions included pulmonary valve stenosis, and retinopathy of prematurity. One day, post vax, on 5/12/01, the infant experienced an episode of apnea, considered to be life threatening. The infant was taken to the ER and admitted. At the time of this report, the infant was still hospitalized.F/U info recd 8/15/01, from the reporter indicated that the pt was a male. who while hospitalized for 6 days underwent a sepsis evaluation in the pediatric intensive care unit.Past medical history was also significant for a left inguinal hernia, lot numbers, immunization routes and sites of administration o f the concomitant vaccines were also provided. the child recovered. MFG of the concomitant vaccines will be notified of this event. Y Y Y U 05/11/2001 05/12/2001 1 UNK F/U 8/15/01 test results were normal PVT OTH NONE UNK Pulmonary valve stenosis; retrolental fibrodysplasia; premature baby, surviving twin. F/U 8/15/01 inguinal hernia HQ0889215MAY2001 1
0170072 05/22/2001 CA 1.0 1 .0 M 05/11/2001 Approximately 3 weeks after immunization, this patient developed acute cerebellar ataxia with cranial nerve since 05/06/2001, which has progressed over the last two days. He was seen in the Pediatric Neurology Clinic for gait ataxia. It was felt that the pt most likely had an acute cerebellar ataxia associated with his recent varicella immunizaiton. He was discharged home after the lumbar puncture. He vomited a few times, likely secondary to his anesthesia, and tolerated two breast-feedings overnight and slept well. At 6am his mother noticed a right eyelid droop and intermittent deviation of the right eye medially. He was able to look fully to the right, laterally, but they were unable to have him look superiorly; it was unclear if this was cooperation versus cranial nerve dysfunction. His ataxia also seemed to have worsened, so that he was now having much more difficulty walking. And he got admitted to the hospital. A follow up report received 12/03/2001 adds: Info has been received from a physician concerning a 12 month old male with a history of gastroesophageal reflux disease (GERD) and no immunosuppression or recent exposure to varicella or other viruses. It was also noted that no one in the pt's household was reported to be ill in recent weeks. On 04/18/2001 the pt was vaccinated with the 1st dose of varicella virus vaccine live (Lot #630975/1061K) in the left leg. It was noted that no rash occurred at the injection site post-vaccination. Concomitant therapy included the 1st dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) (MSD), the fourth dose of Haemophilus B conjugate vaccine (+) hepatitis B vaccine recombinant (yeast) (MSD) (Lot #638136/1589K) into the left leg and the 4th dose of streptococcus pneumoniae vaccine (PREVNAR) (Lot #473349) in the right leg. On approximately 05/05/2001, 17 days post-vaccination, the pt developed a "wide-based gait." The child had difficulty standing (he was previously able to stand unassisted). The pt had to hold onto a wall in order to stand. The symptoms persisted for several days and the pt was taken to the ER on approximately 05/06/2001 and was examined by a neurologist. The pt had an MRI (without contrast) of the brain, which was negative. The pt was sent home from the ER the same day. The following morning, the symptoms persisted, and the parents of the pt also reported a "ptosis of the right eyelid" as well as "deviation of the right pupil." The pt was returned to the ER and admitted to the hospital. The pt was hospitalized for approximately a day and a half, and had another MRI of the brain, with contrast, which was again negative. A lumbar puncture on 05/07/2001 was also performed at the peak of the child's symptoms and a specimen was submitted for PCR analysis on 05/14/2001, and was negative for all VZV. The pt was discharged from the hospital on 05/09/2001. A definitive diagnosis was never made, though the ataxia was felt to be related to an undiagnosed viral infection. Follow-up on 05/19/2001 reported the pt was very much improved. The physician stated that the child was still "wobbly" however a full recovery was expected. Additional info has been requested. Y Y 2 Y 04/18/2001 05/08/2001 20 Magnetic resonance (05/06?/2001) negative-without contrast of the brain. Magnetic resonance (05/07?/2001) negative-with contrast of the brain. Spinal tap (05/07?/2001) negative for VZV. PVT PVT GERD WAES01051340 1
0170073 05/22/2001 NM 12.0 12 F 05/15/2001 This patient became ill in Dec 2000 with myalgia & fatigue after the 1st dose Hep B 11/28/00. Dose # 2 Hep B was given 01/30/01, and continued with constitutional s/sx. Had conjunctivitis 3/01 & continued follow up with local physician. On 05/08/01 was diagnosed with renal failure and subsequently with Wegener's Granulomytosis is currently on hemodialysis and steroids. Also diagnosed with glomerulonephritis, end stage renal dx, deep vein thrombosis, anemia Per annual follow up: auto immune disease, renal failure, dialysis every 2.5 hours. Only able to go to shcool part time. Y Y N 11/28/2000 12/01/2000 3 OTH PUB NONE NONE UNK 1
0170074 05/22/2001 GA 1.0 1 .0 F 05/12/2001 On 04/29, the patient complained of headache. On 04/30, also complained of headache. On 04/31, the baby sitter said she didn't play much and laid around with a headache. On 05/01/01, constantly sleeping, screaming and crying with her head. The baby sitter called the mother a work, the child was screaming with her head and when the light was on it hurt her eyes. Went to the Doctor, who sent her to the hospital for a CT Scan so they can rule out meningitis or a tumor. On 05/02/01, she got up screaming again with pain this time and she had no tears at all, still sleeping, and she was dehydrated. Admitted to the hospital for fluids and to monitor her and run test. About 1 PM that afternoon the mother started to notice these pimple like bumps coming up on her forehead and her nose. When the doctor came the mother told her to check on her and to look at the bumps and she said that it wasn't related at all and that they were not in the pattern of a rash. She named a virus, and she said she thought it was this because it could make your head hurt rea1ly bad. The child ran a low grade fever at night around 100.8. The morning of 05/03/01, the bumps were straight down her forehead to the tip of her nose, like somebody put a ruler to her face and drew a line. They were on the left side of her face and her nose, her eye was red and swollen. The Doctor panicked and said it looked shingles but how? The doctor got another pediatrician to come look. It was defiantly shingles and they were in her eye. They then started her on Acyclovir in her IV. They gave her Tylenol with Codeine for the pain. Later that after noon they brought in an eye specialist to see what to do about her eye. He put her on some dilating drops twice a day and said things should heal fine. Through all of this she slept around the clock until Saturday 05/05/01. That's when a change could be seen and that she was doing better. They released her on 05/06/01. Anytime she gets upset or really cries they come back really red. They have been going to the eye specialist every week for her eye. He had to put her on steroid drops 4 times a day because her cornea was inflammed. She still has pain in her head at times. They are waiting to see what kind of damage it has done to her eye. the mother is also worried about nerve damage and if that is related to the pain she still has sometimes. She never had the chicken pox but she received the vaccine when she was one. The doctor say that her body reacted to it this way. The doctor had never seen it that significant on the face in the pattern it was in. The mother would like to know of any cases like this in young children and how it affected them in the long run. The mother is trying to get all the info on other cases like her daughters, she states 'if you can help please let me know". Diagnosed with Herpes zoster and Keratitis. Per doc 215198, patient's left eye is very sensitive to bright light and sunshine. She has to have sunglasses on in order to be outside. Her depth perception is off, sometimes she runs into things. Also any time she gets upset the red bumps where the shingles were come right back in bright red until she calm down. "Please stay in contact with us about updates or other events of children under five with the shingles in their eyes". Also patient still complains with headache. Y 5 N 07/01/1998 04/29/2001 1033 Urine - fine. Blood work - WBC's 1.700. CT Scan - fine. Eye Specialist - cornea inflammed. PUB PUB 1
0170075 05/22/2001 CA 11.0 11 M 04/15/2001 CFS, Heart palpitations, muscle soreness, headaches, dizziness, spasms, cognitive dysfunction, stomach cramping, trunk rash, night sweats, weakness in knees. Treatment: IV with antibiotic & VHC, Sauna therapy, Bio-Ray Light Therapy, Low Glycemic Diet. More treatments may be needed. The 60 day follow-up states that the pt continues to have light headedness, cognetive issues, stomach problems, sleepin gissues, cold/hot sweats. Some symptoms have improved but he is not the same child as before the shot. The follow up received on 6/13/01 states at the end of January 2001, pt had a flu-liek illness associated with headache and fever. This lasted approximately two weeks. Approximately one day after the fever stopped, he received a hep B shot, which the mother is concerned may be related to his symptoms. He was better for a few days and then he had another flu-like illness for approximately two weeks. He has had intermittent stomachache, no vomiting, occasional headache a few times per week, and no joint pain. For the past two days he has had a rash, however, this has been in an area where his bathing suit is located and he has been in a hot tub over the weekend. The family is concerned because pt has episodes where he is shaky, dizzy, nauseated, lightheaded, and notices numbness around his mouth and hands associated with hypertension. He has had several of these "attacks." Once was at a movie theater and there have been a number of these episodes over the past few weeks. The first episode occurred on 2/16/01. He has been on home hospital schooling for the past two months. There have been a significant number of psychosocial stressors in the house. The parents are in counseling at this time and pt attended his first counseling session 3/2/01; however, it was presented to him that he would be attending family counseling in the middle of February. Pt has a history of irritable bowel syndrome and a history of chest pains, which I have noted in his old medical records. Pt has had a holter monitor, an EKG, a chest x-ray, and numerous lab studies which all have been unremarkable other than intermittent low white blood count. The family provided me with a video today, which demonstrates pt in a hot tub, pt jumping on a trampoline, having fun with his father, and then an episode of one of his "attacks." The video demonstrates pt hyperventilating with some generalized shakiness and he is quite alert and repsonding to his father's numerous questions regarding his symptoms. The overall impression of the video tape is that these episode is psychogenic in origin. While watching this video in the office today, pt began to have another one of his episodes with generalized tremulousness associated with heavy breathing. This lasted approximately one minute. The parents in retrospect note that upon suggestion pt seems to be able to resolve these episodes. A follow-up visit has not been set up at this time, but I would be happy to see pt back at any time if I can be of further assistance. The mother questioned whether further work-up was necessary. I do not feel that any further work-up is needed at this time. However, because the mother is somewhat concerned about this, I have reassured her that there is no identifiable illness that needs treatment immediately and after two months of intensive psychological help, if pt is still having significant symptoms or is worsening at that point I would consider further work-up. Often, medicalizing such illness can worsen the problem and I have emphasized this to the family as well." Y 10 N 01/29/2001 02/16/2001 18 mycoplasma, infections, chlamydia pneumonia PVT PVT Amoxil flu NONE 1
0170076 05/22/2001 KY 34.0 34 F 04/30/2001 Onset of meningitis / encephalitis, approximately one month after TD administration. To my knowledge, no other etiology of encephalitis was found (under care of different MD at a different facility). Per follow up, patient moved. Y U 12/18/2000 01/01/2001 14 PVT PVT Trivora, Acyclovir cutaneous herpes seasonal allergies 1
0170077 05/22/2001 NC 1 .5 F 04/12/2001 8 x 10 cm pink, round rash x 2 days. Motrin and warm compresses. Y 04/10/2001 04/11/2001 1 PVT PUB NONE NONE 1
0170078 05/22/2001 MI 4.0 4 M 04/13/2001 On 04/12/01, 8 1/2 hours post-immunization the patient awoke complaining of both of his thighs. The mother stayed home from work to observe. Motrin every 6 - 8 hrs, warm moist compresses to legs. The child approximately 35 lbs and very thin. Complains of inability to walk, refused to stand upright, crawling and crying. By 4PM he began using his legs. On 04/19/01, per the mother the patient is totally recovered. No more sickness. Y 04/11/2001 04/12/2001 1 NONE PUB PUB NONE NONE MI2001033 1
0170079 05/22/2001 MI 4.0 4 M 04/13/2001 On 4/12/01, 8 hours, post vax, pt complained of pain in both legs in thigh areas. Mom stayed home from work. Gave Motrin every 6-8 hours and applied moist compresses to legs. Child weighs about 35 lbs, very thin legs. Complained of inability to walk and refused to stand up and walk. Was crawling and crying. By 16:00, began using legs. Felt feverish to mom. On 4/19/01, per mom, pt is totally recovered and no more symptoms. Y 04/11/2001 04/12/2001 1 PUB PUB NONE NONE Has a twin brother MI2001034 1
0170080 05/22/2001 CT 1.0 1 .1 F 05/16/2001 Shot administered on Friday, 5/11/01. Pt ran a fever of 102F from 5/12/01 to 5/14/01. Y 05/11/2001 05/12/2001 1 PVT UNK 1
0170081 05/22/2001 OH 0.3 0 .3 F 05/11/2001 Maximum temperature of 103F with inconsolability. Y 04/16/2001 04/16/2001 0 NONE PVT PVT Tylenol Cough X 1 day; afebrile Bronchiolitis 3 weeks prior to shots 1
0170082 05/22/2001 MI 0.6 0 .7 F 05/02/2001 Client seen here for pinpoint rash covering bilateral hands, front and back, and bilateral feet, extending to knees. Sent to MD's office without dx listed on receipt and without treatment requiring a prescription. Y 04/03/2001 04/05/2001 2 NONE PUB PUB OTC Motrin NONE UNK 1
0170083 05/22/2001 MI 1.0 2 .0 F 05/02/2001 Mom called on 4/23/01 to report a pinpoint, red rash over entire bilateral hands and bilateral feet, now extending up to knees on day 2. Mom says that it is already improving. Y 04/20/2001 04/22/2001 2 NONE PUB PUB NONE NONE NONE 1
0170084 05/22/2001 CA 0.4 0 .4 M 05/15/2001 On 5/10/01, had fever to 102F-103F, lasting 3 days. On 5/13/01, macular rash on trunk, face and all extremities and frequent, watery diarrhea with poor appetite. On 5/14/01, exam showed no Koplik's spots; exam not consistent with measles. Looks well. Y Y 05/10/2001 05/10/2001 0 NONE PVT PVT Pedicare NONE NONE 1
0170085 05/22/2001 FL 0.2 0 .2 M 05/19/2001 3 episodes of staring, hypotonia and unresponsive X 15 seconds each episode. Startled and normal acting after episodes. Y 05/09/2001 05/10/2001 1 PVT PVT Tylenol NONE Possible right hip dysplasia; neonatal jaundice 1
0170086 05/22/2001 CA 2.4 3 M 05/11/2001 Child had local reaction 5cm X 7cm raised area and hot to touch. Pt was treated with 5 days of Augmentin 400mg BID and Orapred 5mg BID. Y 05/08/2001 05/10/2001 2 PVT PVT NONE NONE 1
0170087 05/22/2001 CA 0.3 0 .3 M 05/14/2001 Post vax, pt had 6 hours of inconsolable crying, reported by mother. Intermittent crying X 2 days after initial episode. Y 05/11/2001 05/11/2001 0 PVT PVT NONE Prematurity; Alkaline phosphate elevation ~Hep B (no brand name)~1~0.00~In Sibling 1
0170088 05/22/2001 OH 0.5 0 .3 F 05/14/2001 Within 24 hours of 2nd DTAP (pt also got IPV, Comvax and Prevnar), pt had high fever of 103F and very irritable for 48 hours. Two siblings in the family had similar reactions to 2nd DTAP. Y 03/06/2001 03/06/2001 0 NONE PVT PVT NONE NONE ~DTP (no brand name)~2~0.30~In Sibling|~DTP (no brand name)~2~0.30~In Sibling 1
0170089 05/22/2001 MT 0.5 0 .5 M 05/11/2001 Diffuse skin redness on head, trunk and extremities, beginning 24 hours, post vax, and lasting 2-3 hours. Completely resolved without other symptoms. Y Y 05/10/2001 05/11/2001 1 NONE PVT PUB NONE NONE NONE 1
0170090 05/22/2001 UT 0.2 0 .8 M 04/25/2001 Parents state that child began with runny nose 20 minutes, post vax, and within 12 hours, was seen by MD, an IHC Provider, where X-rays were taken and a dx of bacterial pneumonia was made by MD. Treated with antibiotics. Y Y 04/16/2001 04/17/2001 1 X-rays PVT OTH 3/21/01-Amoxicillin 250mg; 3/23/01 Z-pak; Benadryl NONE Possible allergy to Amoxicillin UT011805 1
0170091 05/22/2001 CT 56.0 56 M 05/16/2001 The pt experienced swollen hands, swollen joints of hands, extremely painful. Acute pain in shoulders, hands and legs. Stiffness in hands, arms, legs, neck. Fingers became distorted. Joints locking, and shoulders locked. Problems remain. The follow up stated that the pt has been experiencing more severe neck pain and stiffness coupled with severe headaches. In addition, the symptoms include stiffness, pain, numbness in the lower arms. He recently on 06/11/2001 was a walk-in pt at primary care and saw a physician because he could not get an appointment with his primary care physician within the same group. The physician prescribed CEFTIN 500 mg two times a day which seemed to help his neck pain. He also states that he is planning to see a Lyme disease specialist on 06/18/2001 and he will forward another release form for the new specialist. More severe neck pain and stiffness. New onset HA, stiffness, pain, numbness in low arms, hands, shoulder and legs. Neck pain helped with Ceftin Y Y N 09/01/1999 10/01/1999 30 no rheumatoid factor PVT UNK NONE No joint or muscle problems prior to vaccination. 1
0170092 05/22/2001 SC 26.0 26 M 05/07/2001 After the shot, at least 2 hours, had loss of appetite and nausea. On Saturday, 5/5/01, had redness around the injection site. Redness had gotten bigger on Sunday and experienced chills on Sunday night. Currently, 5/7/01, have a headache. Y U 05/04/2001 05/04/2001 0 MIL MIL NONE NONE Allergic to cats 1
0170093 05/22/2001 HI 1.75 2 .3 M 05/04/2001 Hives, generalized with fever; onset 5 days, post vax. No treatment. Y 04/28/2001 05/03/2001 5 CBC with diff; ESR; UA with reflex PVT PVT NONE NONE NONE 1
0170094 05/22/2001 MA 1.5 1 .5 M 05/11/2001 6cm X 10cm reddened area, minimal swelling. Improved after 24 hours. Y 05/09/2001 05/10/2001 1 PVT PUB NONE NONE Red area~Pneumo (Prevnar)~3~1.25~In Patient 1
0170095 05/22/2001 PA 5.0 1 .0 F 05/14/2001 On 5/12/01, father reported, child developed 30-35 chickenpox lesions on trunk, face and extremities. Afebrile. Y 07/03/1996 05/12/2001 1774 NONE PVT PVT NONE NONE NONE 1
0170096 05/22/2001 OH 13.0 13 F 05/10/2001 Pt received MMRII at school. Presented to school nurse, 1 to 2 hours later, with a complaint of rash on neck. Advised to go to ER. Mom came to school and took her daughter. Doctor dx'd transient rash possibly reaction to MMRII vaccine. Benadryl was prescribed and rash resolved and child returned to school the next day. Y Y 05/09/2001 05/09/2001 0 OTH PUB UNK UNK UNK 1
0170097 05/22/2001 MO 4.0 4 M 04/26/2001 On 4/19/01 had a little cough with a runny nose off and on throughout the day and progressed to a labored breathing with an asthmatic-like cough (deep, barking, croupy cough). On 4/20/01 couldn't catch breath due to coughing forcefully and was given prednisolone at ER. Then complained about right side "cranking my mouth", complained of severe right neck (below ear) pain. No swelling at this time. On 4/23/01 went to NP and had congestion in nose and throat. No swelling noted. On 4/24/01 woke up with right jaw/neck pain with severe swelling. Y Y 04/03/2001 04/19/2001 16 4/24/01-IgG (+); IgM (-) PVT PVT 4/20/01 given prednisone Just recovered from Strep, 2-3 days prior; allergies to codeine, Augmentin, Cedax (antibiotic) at 4 1/2 years old Fever of 104F~DTP (no brand name)~1~0.20~In Patient MO2001028 1
0170098 05/22/2001 MI 3.0 3 F 05/02/2001 Pt wouldn't eat dinner and vomited. Had "small bumps" all over body, child itching on face, legs and trunk. Temperature of 100.2F, irritable and didn't sleep well. Small bumps started to fade. Had a poor appetite and mother brought child in on 5/2/01. Noted small round bumps, light in color. "Still has bumps". Y N 05/01/2001 05/01/2001 0 NONE PUB UNK NONE NONE ~Vaccine not specified (no brand name)~~3.00~In Sibling MI2001036 1
0170099 05/22/2001 MS 4.0 5 M 05/07/2001 Swelling, redness, hot to touch and fever to 102F and restless. Went to ER and was given Claritin and Advil. Ice to leg. Swelling continued but decrease in fever. Saw MD and he gave Advil for fever. Y Y 04/24/2001 04/25/2001 1 PUB PUB NONE Allergy to bee stings MS01017 1
0170100 05/22/2001 CA 11.0 11 F 05/04/2001 Small, red bumps around both eyes, itching, some swelling and also rash on shoulders following Hep-A vaccination #1. Parent gave Benadryl with improvement of symptoms. Did not see MD. Y 04/30/2001 04/30/2001 0 NONE PVT OTH NONE NONE NONE 1
0170101 05/22/2001 CA 4.0 4 M 05/08/2001 Pt returned to clinic on 4/26/01 with redness, swelling on left upper deltoid and erythema. He had edema and hot to touch. Dx'd with left arm cellulitis secondary to puncture skin. Treated with Keflex X 7 days. Cellulitis resolved on 4/30/01. Y Y 04/24/2001 04/24/2001 0 NONE PUB PUB TB skin test/LFA NONE 1
0170102 05/22/2001 CA 0.2 0 .2 M 05/09/2001 Fussiness, low-grade fever 101.5F X 24 hours; when pt seen in office, pt was over bundled and flushed with temperature of 101F; once pt unbundled, without Tylenol, temperature went down to 99.7F and pt not fussy. Y 04/26/2001 04/26/2001 0 NONE OTH PVT NONE NONE Colic 1
0170103 05/22/2001 NJ 58.0 58 F 05/14/2001 Friday at 18:00, 48 hours, post vax, had backache, joints, equilibrium, diarrhea X 1 and periorbital edema on 5/12/01. Took Benadryl po on 5/12/01 PM and it helped with the flu-like symptoms. On 5/14/01, pt with swelling, redness at site with blisters-open/closed. Left arm edema from deltoid; left anticubital area warm to touch. Vital signs 97-64-18 BP 130/80. Y N 05/10/2001 05/11/2001 1 OTH PVT Ginko Biloba, Centrum Silver, Caltrate Laceration to base of left thumb NONE 1
0170104 05/22/2001 CA 47.0 47 M 05/15/2001 Left arm red, swollen, painful and numb. Symptoms began 4 days, post vax. Seen in ER. Treated with Cephalexin 500mg X 5 days and Prednisone 10mg 2 BID X 3 days. Y Y 04/12/2001 04/16/2001 4 PUB PVT NONE 1
0170105 05/22/2001 NM 4.0 4 M 04/27/2001 Left arm red, swollen and warm to touch in deltoid region. Pt afebrile. Y U 04/24/2001 04/26/2001 2 NONE UNK UNK 1
0170106 05/22/2001 NY 68.0 65 F 05/16/2001 Erythema, edema and pruritus in deltoid region of left upper arm. Y Y 05/02/2001 05/05/2001 3 NONE PVT PVT Synthroid, Humulin N Insulin IDDM IDDM; Allergic to PCN and Codeine 1
0170107 05/22/2001 OH 2.0 2 .2 M 05/04/2001 A previously vaccinated child developed approx. 10 lesions during a mild school (6 classmates) outbreak of chickenpox. Y 08/06/1995 04/25/2001 2089 NONE OTH OTH OH0027 1
0170108 05/22/2001 MO 36.0 35 M 05/11/2001 Left deltoid hot, tender and mildly swollen. Painful to use. U 05/10/2001 05/10/2001 0 NONE PVT PVT UTI Splenectomy MO2001029 1
0170109 05/22/2001 CA 11.0 11 M 05/07/2001 2 days, post vax, pt brought to clinic with complaint of headache, pain at site, chest pain and right hand/arm swollen. Y Y 05/01/2001 05/01/2001 0 UNK PUB NONE 1
0170111 05/22/2001 TX 64.0 63 F Pt given Rabavert on 5/8/01 and returned on 5/9/01 with generalized rash. U 05/08/2001 05/09/2001 1 NONE PVT OTH HRIG/618W01A/IM/RFA Exposure to cat bite NONE 1
0170112 05/22/2001 NV 10.0 10 M 05/08/2001 Pt developed a rash all over his body which grew worse over the course of 2 days, until he was completely covered. The doctor prescribed steroids and rash cleared in about 2 weeks. Y Y 04/09/2001 04/20/2001 11 PUB OTH NONE NONE NONE 1
0170113 05/22/2001 OH 2.0 1 1 F 05/10/2001 2 days, post vax, she had a temperature of 102F, followed by vomiting and diarrhea (severe) for 5 days. After antibiotic treatment for 7 days, rash on face. She has suffered since with severe itching, etc. We have since gone to the hospital and they are now treating for extreme car sickness from extreme stress to system. Y N 03/19/2001 03/21/2001 2 Blood test showed an allergic reaction PVT OTH Post vax, given a 7 day course of Bactrim on 3/26/01; Zyrtec on 4/7/01 and Atarax on 4/18/01. NONE Medicine allergies to Zithromax, Amoxicillin, Benadryl, Ceftin 1
0170114 05/22/2001 NJ 36.0 35 M 05/22/2001 Within 48 hours, post vax, pt developed nausea, vomiting, diarrhea, abdominal cramping, shaking and fever. Lasted for 5 days and recovered. Y 04/13/2001 04/15/2001 2 NONE OTH PVT NONE Allergies to grass, pollen, dust, hay fever, sulfamides 1
0170115 05/22/2001 AZ 15.0 15 F 05/14/2001 Soreness in arm, immediately. During the night had chills and aches. Fever is early AM of 100.5F. On 5/11/01, continued with dizziness, achiness and fever. On 5/12/01, recovered. Y 05/10/2001 05/11/2001 1 NONE PUB PUB NONE NONE AZ0117 1
0170116 05/22/2001 AZ 5.0 5 F 05/16/2001 Mother reported swollen cheek, no other symptoms; no fever or respiratory distress. Y 05/10/2001 05/13/2001 3 PUB PUB NONE NONE NONE AZ0116 1
0170117 05/22/2001 AZ 10.0 10 F 05/16/2001 Site of injection had swelling immediately after her shot. No fever or respiratory distress noted. There was burning at the site that lasted 5 minutes. Observed for 15 minutes returned to family with instructions to call family doctor if symptoms reoccur. Y 05/11/2001 05/11/2001 0 PUB PUB NONE NONE NONE AZ0115 1
0170118 05/22/2001 AZ 1.08 1 .1 M 04/27/2001 A mother presented to the clinic on 04/27/00 at 1:30 PM with her child, area of LVL swollen and warm to touch. The mother states the child was warm to touch in the early AM, she didn't take the temp. The mother states the child had redness but no swelling in the area of AVL with immunization on 09/05/00 unknown if the same vaccine. Y 04/26/2001 04/27/2001 1 NONE PUB PUB NONE Redness~DTaP (no brand name)~2~0.40~In Patient AZ0114 1
0170120 05/22/2001 UT 2.0 2 1 F 04/30/2001 The pt experienced chills and the left upper leg was swollen with red area and lump about 20 mm and red patchy areas around lump. The child complained of pain with touch. Treated with Antibiotic Augmentin. U 04/24/2001 04/24/2001 0 PUB PUB NONE NONE NONE UT010404 1
0170121 05/22/2001 UT 4.0 4 M 04/19/2001 The pt experienced hives, vomiting, face redness, left leg swollen and red. Symptoms appeared 15 minutes post vax. No treatment given. Y 04/18/2001 04/18/2001 0 NONE PUB OTH NONE hx of open heart surgery at 10 days old, allergy to milk and dairy products swelling~DTaP (no brand name)~4~3.00~In Patient UT011903 1
0170122 05/23/2001 AZ 0.3 0 .3 M 05/16/2001 The pt died 24 hours post vax. Autopsy pending. COD as per autopsy report was sepsis. Y 04/05/2001 N 04/04/2001 04/05/2001 1 Autopsy - pending PVT PUB Augmentin Otitis Media NONE 1
0170123 05/23/2001 PA 0.8 0 .5 F 10/29/2001 It was reported that an 8 month old patient who received 3 doses of ActHIB developed meningitis (possibly H Influenza type B). Final Lab report confirmed H Influenza type B. Further information is requested. From mailed follow-up contact on 06/06/2001, it was stated the female pt received an ActHIB vaccination on 10/04/2000 dose 1, 11/30/2000 dose 2, and on 02/08/2001 dose 3. After dose three, in May 2001, the pt developed Haemophilus influenzae type e. The pt was hospitalized. The pt reportedly recovered from this experience. From mailed correspondence received on 10/29/2001 it was reported: "Reviewed, no additional information at this time." No further info is anticipated for this report, this case is closed. Y Y 02/08/2001 05/01/2001 82 Final Lab report confirmed H Influenza type B. OTH OTH U2001007320 1
0170125 05/23/2001 CO 39.0 39 F 05/15/2001 Pain in arm (intense), overall sick feeling and nausea. Lost about 15 lbs., vomiting, aching, shortness of breath (intense). Heart pains, spinal contraction/sore muscles, disorientation, at times, dizziness, and numbness. A very disorientating experience and my arm still hurts. Y Y U 05/04/2001 05/04/2001 0 PUB PVT Stress 1
0170126 05/23/2001 MN 1.25 1 .3 M 01/22/2001 After the MMR Shot, the pt quit communicating and regressed into autism.The 60 day follow-up report states autism. Per annual follow-up: "We believe vaccinations have contributed to his autism in conjuction to his weak immune system". Y N 08/24/1998 08/30/2000 737 Autism diagnosed by psychologist on 07/14/00. PVT UNK NONE NONE reflux as baby 1
0170127 05/23/2001 IN 12.0 11 F 05/16/2001 This patient was admitted to the hospital on 08/18/00 after sustaining a 6 day history of frontal headache, weakness of her lower extremities and vomiting. Two days after the initial presentation of her symptoms, she had been given her 1st dose of MMR, Hepatitis vaccine and PPD. The following day she complained of pain in the bilateral thighs and blurry vision. She progressed to having weakness in the lower extremities including foot drop. By 08/19/00 she progressed to the point where she needed intubation and was extubated on 08/26/00.She was transferred to another hospital on 08/31/00, per her parents request. She has struggled with constipation since the onset of her initial symptoms and complains of perianal hypersensitivity and hard stools. At the time of her admission to the rehabilitation Unit, she had significant weakness, extreme range of motion limitations in her shoulders due to pain. She was hyperesthetic to light touch. She displayed upper extremity tremors with any type of cerebellar testing. She had significant facial weakness, speech was clear, had excessive myalgias in the proximal quadriceps. During her hospital course she was noted to have hypertension, noted to have hyperchidrosis of her palms and feet. She was placed on thickened liquids due to some dysphagia. She complained of autonomic problems such as nausea, lightheadedness, and dizziness. By 09/20/00 she was independent, showing slow ongoing improvement. Discharged 10/16/00. Y Y Y Y Y 08/14/2000 08/18/2000 4 CT Scan - showed no mass effect and no hemorrhage. EMG - was consistent with with early demyelinating neuropathy. PVT PVT PPD unspecified. NONE NONE 1
0170128 05/23/2001 TX 46.0 46 F This patient had severe muscle and body pain all over, chills, fast heart beats, and a swollen right arm that is painful to move. Cellulitis Tetanus reaction. Y N 05/02/2001 05/03/2001 1 PVT UNK NONE 1
0170129 05/23/2001 AL 45.0 45 M 05/08/2001 This patient was admitted thru the ER on 11/04/01 with progressive SOB, chest pain in the mid-chest associated only with cough, and deep breath. According to the family the patient there were no new problems until one day after the patient received the influenza vaccine when he ran a fever and became progressively following that injection. The influenza vaccine was given about 1 week PTA. On the day of admission, he developed severe, SOB, and developed pleuritic chest pain. RR 28, o2 Sat 50%, O2 by mask was 90% on admit. Also 1-2 + pitting pedal edema present the day of admission. Chest x-ray revealed pneumonia. Initial cardiac enzymes were negative. On admit the patient had scattered rhonchi. Y Y U 10/27/2000 11/04/2000 8 RR 28, o2 Sat 50%, O2 by mask was 90% on admit. Also 1-2 + pitting pedal edema present the day of admission. Chest x-ray revealed pneumonia. Initial cardiac enzymes were negative. UNK UNK Morbid obesity (411 lbs, 5'5"), seizure disorder (long standing history), history of GERD, mild to moderate mental retardation, NKDA, history of medication noncompliance, and type II diabetes mellitus. 1
0170130 05/23/2001 MN 0.8 0 .8 M 04/30/2001 Transverse Myelitis. Hospital dates 1/7/01-02/09/01. The 60 day follow-up the doctor states that, "I don't think that this disease is related to the vaccines given." Follow up: Patient is a 10-month old boy who presented to the ER with fever, extreme lethargy, and some vomiting. He had been in good health in the morning, and then around noon that day became whiny and seemed not to feel well. He vomited once later in the afternoon. Subsequently he was listless and floppy. He started to develop low-grade fevers around 100.5. He started to refuse to eat. Because of his listlessness and fever, plus the fact that he had not had a wet diaper for many hours, he was taken to the ER. Y 32 Y Y N 12/15/2000 01/07/2001 23 Adenovirus IgG 1:4 (1/9/01), 1:8 (1/24/01); CT scan: Transverse Myelitis PVT OTH NONE NONE 1
0170131 05/23/2001 NY 1.6 1 .6 F 05/16/2001 On 5/12/01, the pt began vomiting. On 5/13/01 the pt was asymptomatic. On 5/14/01, the pt experienced seizures. The pt was afebrile. Y Y Y U 05/10/2001 05/12/2001 2 PVT UNK Eczema Shoulder dystocia at delivery, hx of ear infections, eczema 1
0170132 05/23/2001 FL 0.2 0 .2 M 05/15/2001 One day post vax, the pt began to have episodes of jerking then of jerking and staring. These were brief occurring 2-3 times a day. Over the next several weeks, the episodes became more frequent. He required hospitalization for seizure control and was diagnosed with infantile massive spasms. He has since become severely developmentally delayed and microcephalic. He is on medication but his seizures are not controlled. Y 17 Y N 07/19/2000 07/21/2000 2 EEGs - abn, MRI - normal, metabolic or infectious disease. PVT PUB NONE NONE NONE 1
0170133 05/23/2001 PA 1.5 1 .5 M 05/02/2001 The pt experienced 3 seizures, the first one a few seconds duration, the 2nd one 45 minutes in duration. The 3rd one stopped with Valium or Ativan in ER. Also diagnosed with viral gastroenteritis. Follow up on 09/18/2001: "The awake recording shows a 6-8 Hz moderate voltage occipital dominant rhythem that blocks with eye opening, large amounts of low voltage 14-20 Hz activity, frontal dominant, small amounts of moderate to low voltage scattered 3-5 Hz activity. Photic stimulation produced a moderate driving response. Hyperventilation was not performed. Sleep was acheived. K complexes, vertex sharp waves and symmetrical sleep spindles were noted. IMPRESSION: Normal EEG." Y Y 5 Y 12/21/2000 12/23/2000 2 EEG - normal PVT OTH NONE NONE NONE 1
0170134 05/23/2001 CA 1.5 1 .5 M 05/04/2001 After receiving vaccines, the pt would not walk, had persistent crying, fell asleep. The child had chills and cold skin, the child laid down, fever started at 106. The pt was given cool bath, temp reduced to 103. ER visit and was instructed to give Tylenol, and Motrin alternating for the next 48 hours. The next day at 1:30 PM the child was screaming, found seizing, laying on his back, arms up, eyes fluttering, verbal repetitive gasping cry, child seized for about 3 minutes. Ambulance called, the pt was taken to the ER. No neurological findings, released at 10:03PM. Instructed to give Tylenol and Motrin alternating. Y Y Y U 04/05/2001 04/05/2001 0 MR, EEG, CT, CXR, blood tests and spinal tap PVT UNK NONE NONE NONE 1
0170135 05/23/2001 MT 1.0 1 .0 F 05/17/2001 Reddened and swollen legs (lower right and left) at 17:05. Iced reddened areas and given 3/4 tsp of Benadryl. Y U 05/17/2001 05/17/2001 0 NONE PVT UNK Fluoride NONE Premature 1
0170136 05/23/2001 LA 1.25 1 .3 M 05/12/2001 Had fever of 103.5F and seizure X 5 minutes. On 5/12/01, was stable without distress and with normal neuro exam, 4 hours, later. Y Y 05/11/2001 05/12/2001 1 Normal neuro exam PVT PVT Pulmicort; Zyrtec NONE 1
0170137 05/23/2001 SD 0.8 0 .8 M 05/15/2001 12 hours, post vax, 3rd Prevnar (given on 5/11/01), child had fever of 102F and "hives" at injection site with red linear welt, had vomited X 3 over a 2 day period of time. Came to office on Monday. Symptoms subsided. Y 05/11/2001 05/12/2001 1 CBC on 5/14/01 PVT PVT NONE NONE 1
0170138 05/23/2001 PA 0.3 0 .3 M 05/15/2001 Ear infection; tearing eyes with green discharge; fevers and vomiting. N 02/27/2001 02/28/2001 1 NONE PVT PVT NONE NONE NONE 1
0170139 05/23/2001 SC 1.0 1 .1 M 05/17/2001 Temperature of 103F and above, since this morning at 03:30 on 5/17/01. Y Y 05/16/2001 05/17/2001 1 PVT PVT NONE 1
0170140 05/23/2001 CA 0.4 0 .4 F 05/16/2001 Within 2 hours, she was vomiting and had a low-grade fever of 99.8F. She was irritable, loss of appetite and constant crying. This lasted for 2 days. She also had horrible gas during this time. We gave her Tylenol and held her all through the night. Y 05/08/2001 05/08/2001 0 PVT OTH NONE NONE 1
0170141 05/23/2001 OH 1.6 1 .6 M 05/17/2001 Erythema and swelling at injection sight on right thigh. Also had urticaria on face and back. Given Benadryl and observed X 45 minutes. Urticaria resolved and pt discharged with instructions to continue Benadryl for the next 2 days. Y 05/15/2001 05/15/2001 0 NONE PUB PUB NONE NONE NONE 1
0170142 05/23/2001 IN 0.2 0 .2 M 05/19/2001 Temperature of 104F, rash to body and fussy. Treated with Tylenol. Y Y 03/28/2001 03/28/2001 0 PVT PVT 1
0170143 05/23/2001 GA 0.3 0 .3 M 05/17/2001 Parent describes that approx. 3 hours, post vax, right leg had reddened area the size of a tennis ball. Parent applied cold compresses and administered Tylenol as advised. Area has now decreased in size (golf ball sized) reddened area. No hardness; not warm to touch. Child in no distress. Y 05/15/2001 05/15/2001 0 NONE PUB PUB NONE NONE NONE 1
0170144 05/23/2001 MO 0.3 0 .3 F 100.7F-102F fever, lethargy and dehydrated. Y Y 05/15/2001 05/15/2001 0 PVT PUB Unspecified reaction~DTaP (no brand name)~~0.20~In Patient MO2001030 1
0170145 05/23/2001 RI 1.4 1 .4 M 05/19/2001 Morbilliform rash on face, trunk and extremities. Y 05/03/2001 05/11/2001 8 PVT PUB 1
0170146 05/23/2001 OH 0.3 0 .2 M 05/16/2001 Per mom, pt slept for 2 days, post vax, awakening only to feed. Held up head in hospital at birth but didn't after immunizations. She reports, pt walked across table at 2 month visit; couldn't bear weight after immunizations. Noted increased sleeping and decreased tone 2-3 weeks after immunizations. Then one morning "snapped out of it". No report to MD's office and no call. No fever. Y 03/20/2001 03/21/2001 1 PVT PVT 1
0170147 05/23/2001 FL 0.2 0 .2 F Starting about 4 hours, post vax, child fell into a deep sleep. Wouldn't wake on her own for 3 days. ER visit at 36 hours, post vax. Symptoms included extreme sleepiness and fever (102F rectally). Blood culture and CBC done and all were normal. No treatment. Child recovered on her own after about 3 days. Y Y 02/22/2001 02/22/2001 0 CBC; blood cx-all wnl MIL MIL NONE NONE NONE 1
0170148 05/23/2001 VA 0.2 0 .2 M 05/16/2001 Onset of bloody stools, 10 hours, post vax. Since then, continuous diarrhea. Has developed various food allergies since the administration of vaccine. N 10/04/2000 10/04/2000 0 Colonoscopy to confirm food allergy PVT PVT NONE NONE NONE 1
0170149 05/23/2001 CA 1.0 0 .0 F 05/21/2001 On 5/16/01, parents described induration, erythema and pain on right upper thigh, post vax. On exam: right upper thigh 4cm X 5cm area of induration, ITP and indention. Prevnar and MMRII both given in RVL but unclear which vaccine caused reaction. Dx'd with adverse reaction to vaccine or vaccines? Withhold from giving either in future. Parents informed, aware and comprehend. Y 05/09/2001 05/09/2001 0 NONE PUB PUB NONE NONE NONE 1
0170150 05/23/2001 IL 1.8 1 .9 F 05/16/2001 Redness (circumference about 2cm) which started 24 hours, post vax. Y Y 05/14/2001 05/15/2001 1 PVT PUB NONE Allergy to Erythromycin 1
0170151 05/23/2001 PA 22.0 21 M 05/10/2001 General feeling of "flu-like" symptoms, very, very tired. Had trouble staying awake while driving, night sweats, drained, trouble concentrating while reading, muscle soreness, body aches and pains: wrist, knee, ankle. Symptoms have subsided but still exists. Had 2nd shot on 6/12/00. Y N 05/09/2000 05/10/2000 1 Eliza test performed on 8/4/00 which showed no antibodies. Doctor may have information regarding ? PVT OTH Effexor NONE Clinical depression 1
0170152 05/23/2001 NC 37.0 37 M 05/17/2001 Arthritis throughout body in joints. A large red spot at injection site, growing larger, that itches, intermittently. Arm is sensitive to touch, starting 2 days, post vax. N 05/15/2001 05/17/2001 2 MIL MIL Motrin NONE NONE 1
0170153 05/23/2001 NV 36.0 36 F 04/30/2001 On Monday and Tuesday had a headache. Wednesday had coughing, sneezing and then hives all over body that lasted approx. 1-2 hours. Then after taking Benadryl, the rash appeared mild until the next day. Y 04/23/2001 04/25/2001 2 PUB PVT NONE NONE 1
0170154 05/23/2001 CA 44.0 43 F 03/30/2001 I felt very sick with temperature and a deep pain in my upper arms, bones, (included the elbows) and couldn't separate my arms from my trunk (it hurt). I was weak and I only wanted to lay down. I couldn't cook or nothing, not to help my children and I was in pain and when I lifted something, it hurt, I didn't want to eat (lost appetite). My symptoms lasted for 3 or 4 days, but from that day, I feel the pain return once in a while again for 1 or 2 days and then is gone. In different parts of my bones (upper arms, elbows, legs mainly) since then my fingers hurt and I don't remember it being like that before. Until now, I prefer to ignore the pains, it's not like it stopped me to do my things. It is sufferable but it put me in a bad mood because I have to do a lot and with that latent pain, it is harder. It called my attention, especially because the pain was in both arms, not just the one with the vaccine. By the way, the area where I received the shot was swollen, hard to the touch and red, like when a bee stings you. The redness was about the size of the palm of my hand and made me nervous to look at it because it was like all that area was above the surface of the rest of the skin and the skin was hot in that red area. But some days, I'm perfectly ok, with no pain at all. Y 01/09/2001 01/10/2001 1 NONE PUB PUB Prenatal vitamins NONE NONE 1
0170155 05/23/2001 CA 3.0 3 M 05/16/2001 Pt was vaccinated with varicella on 5/7/01. On 5/12/01, per mom, pt has skin lesion on face and left hand and finger. Questionable skin lesion. Looks like chickenpox reaction. Lesions appear healing. No other symptoms. Denied fever. No meds given. Y 05/07/2001 05/12/2001 5 PUB PUB NONE Neck lump NONE 1
0170156 05/23/2001 OH 2.0 2 .1 M 05/10/2001 Pt was seen on 5/3/01 for a well child exam and given vaccines. On 5/5/01, pt was developing redness and swelling at injection site. On 5/8/01, redness and swelling persisted along with a low-grade fever. Pt was seen in the ER on 5/8/01 with an area of redness, slight swelling over the outer aspect of the right upper leg. Pt was given Rx for Augmentin and follow-up appt. and was told to discontinue Augmentin. Dx: local reaction to DTAP. Y Y 05/03/2001 05/05/2001 2 NONE PVT PVT URI Allergy to Omnicef; speech delay 1
0170157 05/23/2001 MI 1.25 1 .2 F 05/16/2001 Area around the vax site was red, indurated and vesicular. The child was started on Benadryl and Duricet for 10 days. Y Y 05/14/2001 05/15/2001 1 NONE PVT PVT NONE SOM 1
0170158 05/23/2001 OH 28.0 28 F 04/27/2001 MMR given at 11:20 on 4/27/01; at 12:15, started with tight cough, difficulty breathing, audible wheezing and decreased breath sounds. Taken to ER and stabilized. Transferred to adult ER. Y Y 04/27/2001 04/27/2001 0 UNK UNK Mantoux TB skin test/C0630AA/RFA on 4/27/01 Routine heath assessment 1
0170159 05/23/2001 MI 1.0 1 .1 F 05/10/2001 On 5/10/01 at 09:20, telephone call from mom reporting that on 4/30/01 got shots. Gave Tylenol for fever of 102F during the night. On 5/8/01, had rash of 10 red, flat, macular "spots" over both shoulders. On 5/9/01, rash covered all of body (flat). She was fussy, probably itching, and did not sleep during the night. On 5/10/01 AM, trunk now as red as extremities. No one else ill, no rash contacts. Mom baby sits 1-3 other children. No new foods or soaps. No treatment to date. On 5/10/01, still had rash. Advised mom to call PMD. On 5/19/01, telephone call to mom and she said that MD saw pt and said it was measles reaction . No treatment. On 5/14/01, rash gone. Y Y 04/30/2001 05/08/2001 8 PUB PUB NONE NONE NONE 1
0170160 05/23/2001 ME 5.0 5 M 05/16/2001 Chickenpox, at least 200 spots, very itchy, lasted 6 days until scabbed over; was still contagious; 2 siblings came down with chickenpox, 15 days later. Y 02/18/1999 03/09/2001 750 PVT PVT Insulin Diabetes Mellitus Type I 1
0170161 05/23/2001 KS 19.0 19 M 05/11/2001 Pt complained of nausea, light-headedness, post vax, (onset about 30 minutes). Pt had 3 episodes of "blackout" while playing basketball. Pt complained of SOB, cough, scratchy throat on 5/11/01, seen in clinic and received Solu-Medrol 125mg, IM and Albuterol treatment. Y Y 05/10/2001 05/10/2001 0 CBC-wnl; Complete metabolic profile-wnl; CXR-wnl; ESR-wnl; Pulse Ox 98% on RA MIL MIL 1
0170162 05/23/2001 MO 5.0 5 M 05/16/2001 2cm induration at injection site. Y 05/14/2001 05/15/2001 1 PVT PVT NONE 1
0170163 05/23/2001 MA 3.0 3 F 05/14/2001 Increased blanching, redness, swelling and itching to right deltoid, 15-45 seconds, thereafter. States localized to general arm under axilla. Treatment: Benadryl, ice and watched pt X 2 hours. Follow-up appt. next day. Y 05/03/2001 05/03/2001 0 NONE PUB PUB NONE NONE 1
0170164 05/23/2001 HI 1.0 1 .1 M 05/12/2001 7-10 days, post vax, child experienced red, vesicular rash on his torso. No SOB, no hives and no allergic reaction. U 05/02/2001 05/09/2001 7 UNK UNK Lasix 10mg; Orgaran 50mg; captopril; baby ASA Pulmonary atresia, VSD, tetralogy of Fallot 1
0170165 05/23/2001 HI 1.0 1 .0 M 05/12/2001 7 days, post vax, child experienced red, vesicular rash on his torso. No SOB. No hives. No allergic reaction. 05/02/2001 05/09/2001 7 UNK UNK 1
0170166 05/23/2001 CA 1.25 1 .3 M 05/11/2001 Prevnar administered on 5/7/01 in left thigh. Injection site with small knot and slight redness of skin over site. U 05/07/2001 05/08/2001 1 NONE PVT PUB NONE NONE NONE 1
0170167 05/23/2001 AK 33.0 33 F 05/14/2001 Received shot on 5/8/01. On 5/9/01, felt flushed, that night my temperature was 101.2F, with hot/cold flashes and night sweats. Fever broke, continued to feel flushed. On 5/11/01, right arm felt hot with red spots to about my elbow. Seen by MD at 18:00 and received antibiotics. Y Y 05/08/2001 05/09/2001 1 MIL MIL TB 1
0170168 05/23/2001 KY 45.0 45 F 05/15/2001 On 5/14/01, pt had onset of swelling to hands (bilaterally), knees and ankles. Went to PCP. Off work X 5 days for arthritis symptoms. U 04/23/2001 05/14/2001 21 NONE PUB PVT NONE History of arthritis; No med. Rx. Had rheumatic fever as a child. 1
0170169 05/23/2001 OK 4.0 M 05/15/2001 Varicella given, however, broke out with full case of chickenpox. Y 06/12/1998 05/08/2001 1061 PVT PUB NONE NONE 1
0170170 05/23/2001 CT 13.0 12 M 05/10/2001 DT administered on 4/30/01 in left upper extremity. On 5/2/01, had moderate left upper extremity erythema, induration and tenderness. Treated with elevation, ice, analgesics and cephalexin with good resolution of symptoms. Y Y 04/30/2001 05/02/2001 2 PVT UNK NONE NONE 1
0170171 05/23/2001 WA 4.0 4 F 05/04/2001 The pt experienced left deltoid excoriation's, red wheals, swollen palpable mass, and nightmares. Y Y 05/01/2001 05/02/2001 1 PVT PVT NONE 1
0170172 05/23/2001 OH 0.9 0 .5 F 05/04/2001 Baby started gasping for breath; baby passed out. Squad was called. Received O2 and Epinephrine. Y Y 11/16/2000 11/16/2000 0 PUB PUB NONE 1
0170173 05/23/2001 CA 18.0 18 M 05/07/2001 Sore arm when I sleep at night. It has been almost 2 weeks, since I had the TD shot. I took acetaminophen (2) and ice. Now advised to take ibuprofen and use warm compresses. Y 04/25/2001 04/25/2001 0 OTH PUB NONE Pollen allergy 1
0170174 05/23/2001 WI 5.0 5 M 05/10/2001 Raised lesion with erythema; baseball-sized area. No systemic effect 3 days later, after initial swelling. Y Y 04/30/2001 05/02/2001 2 PVT UNK Mental retardation after CP 1
0170175 05/23/2001 ME 5.0 1 .8 F 05/11/2001 Previously vaccinated, a 5 year old presented to office with 100 + vesicles, papules (small scabbed) over face, chest, trunk, abdomen and legs. Dx: breakthrough varicella. Y Y 09/03/1997 05/03/2001 1338 Sent crusts to lab for PCR testing PVT OTH PCN allergy; eczema 1
0170176 05/23/2001 OH 0.3 0 .3 M 05/08/2001 On 5/7/01, parents declined administration of Prevnar #2; parent states that Prevnar #1 given on 2/22/01 and within 6 hours, had a fever of 103.4F, lasting for 36 hours, labored breathing X 24 hours. Child was not seen in our office or ER for these complaints. MD felt that these symptoms were probable concurrent viral resp. illness. Y 02/22/2001 02/22/2001 0 PVT PVT Tylenol prn 1
0170177 05/23/2001 MI 4.0 4 F 04/16/2001 Child became irritable on 4/13/01 and 4/14/01. On 4/15/01, she developed maculopapular "bumps" in front of left and right axilla, 1 on abdomen, 1 on back of arm and 1 on back of leg. Slight itching. States daughter feels a little warm but did not measure temperature with thermometer. Mom advised to have evaluated by physician. On 4/15/01, telephone call from pt's mom. Did not see physician. Had 2 more bumps on abdomen today, 1 on back of leg and 2 near feet. Macularpapular (not becoming smaller in size). On 4/26/01, a few bumps faded away and the rest scabbed over and cleared up. She is feeling well. Y 04/12/2001 04/13/2001 1 PUB UNK NONE NONE NONE MI2001035 1
0170178 05/23/2001 VT 45.0 45 M 05/03/2001 Client denied sensitivity to latex, bananas, kiwis, avocados, European chestnuts and also denied sensitivity to Hep-B vaccine components and any adverse reactions to vaccines. The next AM, approx. 20 hours, post vax, he reported to me that his hands were very swollen and itchy. 3 hours later, he had head to toe hives. Recommended he not use latex gloves again and to consult his MD. Y Y 04/16/2001 04/17/2001 1 PUB PUB NONE Hypertension 1
0170179 05/23/2001 CO 61.0 61 F 05/18/2001 Normal soreness the 1st 3 days. Extreme local pain returned on 5/12/01 and 5/13/01. Saw doctor on 5/14/01 with follow-up on 5/21/01; taken antibiotic and Ultram for pain and doing better as of 5/19/01 or so but still some pain. N 05/01/2001 05/01/2001 0 PUB PVT Levoxyl; Premarin Low thyroid 1
0170180 05/23/2001 CA 4.0 4 M 05/21/2001 Rash all over body and fever of 101.6F on Friday but rash developed on Sunday. Exam on 5/21/2001 showed skin with multiple pinpoint blanching, erythema papules distributed all over his arms, legs and trunk. Pt was prescribed Benadryl 12.5mg and Calamine lotion. U 05/18/2001 05/20/2001 2 PVT PUB PPD/Aventis/C0578AA/ID/RFA NONE 1
0170181 05/23/2001 IL 4.0 4 F 05/17/2001 6cm X 6cm erythema with swelling and painful. Y Y 05/14/2001 05/15/2001 1 NONE PVT PUB NONE NONE NONE 1
0170182 05/23/2001 NM 6.0 4 M On 5/1/01, child comes to office complaining of itchy rash with fever. On exam, by doctor, found multiple small separate erythematous macules, some early vesicles and some small eschar. Treatment: no school until all lesions scab over; Caladryl lotion for topical application. Y 02/03/1999 05/01/2001 818 PVT OTH NONE NONE 1
0170183 05/23/2001 NH 0 .0 F 05/14/2001 Suppression of immune system the first 4 weeks of life. Resistant to Rx oral meds. Frequent infections for 2 1/2 years. Severe adult type mononucleosis with liver enzymes increased. Delayed maturity of nervous system. (Excellent mother, not working. 2 1/2 year breast feeding). U 05/21/1994 PVT PUB NONE NONE 1
0170184 05/23/2001 FL 5.0 4 F 04/26/2001 15cm X 8cm raised wheal, inflammed lower left thigh, no treatment. Resolved after 7 days. Y Y 04/24/2001 04/24/2001 0 NONE PVT UNK NONE NONE 1
0170185 05/23/2001 IN 12.0 10 U 05/16/2001 The pt experienced an indentation, probably necrosis of the left shoulder. U 10/13/1999 01/05/2001 450 PVT PUB Adderal, asthma, ADHD 1
0170187 05/23/2001 TN 1.2 1 .2 F 05/17/2001 Within 10 minutes of vaccine the pt experienced a large red whelp. No systemic symptoms. Y 05/17/2001 05/17/2001 0 NONE PVT PUB NONE NONE NONE 1
0170188 05/23/2001 IL 2.0 2 .0 M 05/18/2001 The pt developed left thigh redness and swelling with warmth to the touch. Y 05/16/2001 05/17/2001 1 PUB UNK 1
0170189 05/23/2001 NH 16.0 16 F 05/17/2001 Within 6 hours of vax, the pt developed pain at the injection site, spreading upward to neck, then nausea, headache, fever, malaise, anorexia, dizziness, facial flushing. Started to improve after 24 hours with residual headache and shoulder/neck pain. Y Y 05/14/2001 05/14/2001 0 NONE PVT OTH NONE 1
0170190 05/23/2001 NE 0.2 0 .2 M 05/16/2001 The night of the vaccines, the pt fell asleep and when mom put child in crib, the baby arched back and head repeatedly over 10-15 seconds. Unknown if any color changes or if eyes opened or rolled back. No fever. Mom concerned if this may have been a seizure. Y 03/19/2001 03/19/2001 0 PVT PVT NONE NONE fussy baby, milk protein intolerance 1
0170191 05/23/2001 MI 30.0 30 M 04/11/2001 The pt's right arm was red, swollen and hurt to the point he couldn't move it. By the next day, the swelling went down the the pain started to go away. N 04/07/2001 04/08/2001 1 MIL UNK NONE NONE 1
0170192 05/23/2001 WI F 12/27/2000 A pharmacist reported that a female adult may have inadvertently received an ID injection of TD Adsorbed, Purogented on 8/16/00. The nurse who administered the injection is not certain whether she gave PPD or TD Toxoids, Purogenated. Following the injection, the pt developed an injection site reaction characterized by itching, redness and soreness. She recovered. Y 08/16/2000 UNK OTH OTH UNK NONE UNK HQ0004318AUG2000 1
0170193 05/23/2001 PA 16.0 16 M 10/13/2000 A nurse reported that a 16 year old male received an injection of TD Toxoids Adsorbed, Purogenated on 6/28/00. On 6/30/00, the child developed an injection site reaction characterized by swelling and erythema. On 7/1/00, he was seen by the physician. The reporter notes that the mother took the child to see another physician, who treated the child for "infection" at the site. The child recovered by 7/6/00. Y Y 06/28/2000 06/30/2000 2 UNK PVT OTH UNK UNK UNK HQ0534331AUG2000 1
0170194 05/23/2001 LA 41.0 41 M 10/18/2000 A nurse reported that a 41 year old male received an injection of TD Toxoids Adsorbed, Purogenated on 8/29/00. The next day, the pt developed a fever and achiness. On 9/7/00, he developed right arm pain extending from shoulder to elbow. He was dx'd with right arm peripheral neuropathy. The pt was treated with ibuprofen, Medrol (methylprednisolone), and Soma (carisoprodol). Y U 08/29/2000 09/07/2000 9 UNK PVT PVT Vitamins NONE UNK HQ1071115SEP2000 1
0170195 05/23/2001 NY 39.0 39 F 07/20/2000 Same day of vax, the pt developed swollen lymph nosed, muscle pain and a stiff neck. On 4/5/00, the pt self-treated with Advil and Bengay and had reported some relief. As of 5/18/00, the reporter noted that the pt had significant muscle tightness throughout her shoulders neck and chest. She was being treated with ibuprofen and physical therapy. Y U 03/22/2000 03/22/2000 0 Neck x-rays and blood work were normal OTH OTH Claritin NONE UNK HQ2242607APR2000 1
0170196 05/23/2001 NC F 01/08/2001 A pharmacist reported that a female, now 77 years of age, received an injection of TD Toxoids, (manufacturer unknown) as a child. Subsequently, she became "very sick". The pt recovered. Y UNK OTH PVT UNK UNK UNK HQ2919030OCT2000 1
0170197 05/23/2001 OH 40.0 40 M 02/27/2001 A physician reported that a 40 year old male received an injection of Tetanus and Diphtheria Toxoids Adsorbed, Purogenated on 11/8/00. The nest day, the pt developed pain at the injection site. Follow-up information received from the physician on 2/21/00, indicated that the pt was seen by the physician on 11/10/00. At that time, the pt complained of anxiety, myalgia and discomfort with left arm movement. The physician reported that the pt had "full motor function and no sensory deficits". He was treated with prednisone and Ativan (lorazepam). U 11/08/2000 11/09/2000 1 UNK PVT PVT NONE NONE Neck pain HQ3852117NOV2000 1
0170198 05/23/2001 PA 27.0 F 06/05/2000 A female reported that she received an injection of TD Toxoids Adsorbed, Purogenated in 1994, when she was 27 years of age. At the time of vaccination, she was pregnant; trimester of pregnancy at vaccination was not provided. The reporter, subsequently, delivered a normal child. Since that time, she has been unable to conceive. U UNK PVT PVT NONE Wound UNK HQ4088621APR2000 1
0170199 05/23/2001 TX 45.0 45 F 12/27/2000 A nurse reported that a 45 year old female received an injection of DT Toxoids Adsorbed, Purogenated on 8/19/00. On 8/23/00, the pt experienced flu-like symptoms. She also developed an injection site reaction characterized by "extreme" soreness, erythema and edema. This is 1 of 4 pts from this facility who had an adverse experience following receipt of TD Toxoids Adsorbed, Purogenated lot 471038. U 08/19/2000 08/23/2000 4 UNK OTH OTH UNK UNK UNK HQ4662808DEC2000 1
0170200 05/23/2001 MI 12.0 F 01/11/2001 A mother reported that her daughter, now 14 years old, received TD vaccine in 1998 and subsequently, developed an upper respiratory tract infection. She recently developed cold symptoms that the reporter believes are related to previous vaccine administration. The adolescent was seen by a physician and received testing for allergies and blood work. MCV and MCR were reported to be elevated and allergy testing results were unknown. Y U Mean cell volume increased; Mean cell haemoglobin increased; Skin test-allergy testing results unknown. OTH OTH UNK UNK UNK HQ5676908JAN2001 1
0170201 05/23/2001 OH 42.0 42 F 01/23/2001 A 42 year old female received an injection of TD Toxoids Adsorbed, Purogenated for a leg laceration on 3/28/00 and that same day, reportedly developed left arm pain and difficulty moving her arm. The pt indicated that immunization was administered 3" or 4" from the top of her left shoulder and that her arm pain has been worse in the morning, "throbbing and hurts in shoulder". She stated that during the day, her pain has been a deep aching, "feels like the muscle is damaged". She also stated that she has no strength in her arm and has difficulty lifting objects. Several weeks ago, the pt experienced numbness of her left wrist and fingers. As of 5/16/00, the numbness had resolved. She was seen by a physician who indicated that "the bone may have" been "nicked during the injection" and "it may take 6-8 weeks to heal". As of 5/16/00, her injection site reaction, deep aching and throbbing of her left arm, decreased left arm strength and difficulty moving her left arm, persisted. U 03/28/2000 03/28/2000 0 UNK PVT OTH UNK Leg laceration Fall; joint sprain; ligament sprain HQ5978816MAY2000 1
0170202 05/23/2001 OR 57.0 57 F 07/25/2000 A 57 year old female with rheumatoid arthritis treated with Enbrel, methotrexate and ibuprofen reported that she received an injection of TD Toxoids Adsorbed. After immunization, she stated that her rheumatoid arthritis symptoms "felt better then got worse again". The pt reported that she had developed influenza, an eye infection and an ear infection approx. 4 weeks prior to immunization. At that time, her rheumatologist discontinued methotrexate therapy. U 05/01/2000 UNK PVT OTH Enbrel, ibuprofen, Premarin, Thyroid, Verapamil, vitamins NOS, acetylsalicyclic acid, Beclomethasone UNK Ear infection NOS; eye infection NOS; Influenza; Rheumatoid arthritis HQ7234513JUN2000 1
0170203 05/23/2001 OH 19.0 F 08/31/2000 A nurse reported that a 19 year old female received an injection of TD Toxoids Adsorbed, Purogenated on 5/23/00 and subsequently developed an injection site reaction characterized by a rash, redness, swelling, pain and warmth. The pt also developed hives which persisted for at least 5 to 6 days. This is 1 of 2 pts from this facility who had an adverse experience following receipt of TD Toxoids Adsorbed, Purgenated, lot 468868. Y 05/23/2000 UNK OTH OTH NONE UNK NONE HQ7549220JUN2000 1
0170204 05/23/2001 NJ 39.0 39 M 10/16/2000 An MA reported that a 39 year old male received an injection of TD Toxoids Adsorbed, Purogenated on 6/19/00. That evening, he developed fever and memory loss. He was seen by the physician on 1/20/00. His temperature was 102F, with 45 minutes, it rose to 104F. The pt vomited. He was found to be dehydrated and was treated in the physician's office with 850 mL IV 0.9% sodium chloride. Blood culture and unspecified "lab work" were performed. Liver function tests were found to be abnormal. The pt was sent home. He was recovering as of 6/22/00. Follow-up received on 8/28/00, indicated that the pt's blood cultures were negative. The pt recovered. Y Y 06/19/2000 06/19/2000 0 Liver function test NOS-abnormal; On 6/20/00, blood cultures-negative PVT OTH UNK NONE UNK HQ7706222JUN2000 1
0170205 05/23/2001 AZ 83.0 83 F 07/25/2000 A physician reported that a 83 year old female sustained an injury to her lower leg on 5/4/00. Because she could not recall ever being immunized against tetanus, the physician initiated the primary immunization series, she received her second dose on 6/6/00. That day, she developed an injection site reaction characterized by an area of swelling, redness and pain measuring 4" by 4". By the time she was evaluated by the physician, the reaction had resolved. Y Y 06/06/2000 06/06/2000 0 UNK PVT OTH Potassium chloride; Premarin; vitamins NOS; Calcium; Hydrochlorothiazide Lower leg wound UNK HQ7831126JUN2000 1
0170206 05/23/2001 F 08/09/2000 A female reported that she inadvertently received an ID injection of TD Toxoids Adsorbed, Purogenated on 7/27/00, instead of PPD. She subsequently, developed an injection site reaction characterized by redness and induration. The reporter declined to provide additional information and declined to grant permission for follow-up investigation. U 07/27/2000 UNK OTH OTH UNK UNK UNK HQ9478307AUG2000 1
0170207 05/23/2001 MD F 08/09/2000 A physician reported that a female inadvertently received an ID injection of TD Toxoids Adsorbed, Purogenated on 8/1/00. The next day, she developed an injection site reaction characterized by redness and swelling. U 08/01/2000 08/02/2000 1 UNK PVT PVT UNK UNK UNK HQ9494607AUG2000 1
0170208 05/23/2001 OH 49.0 49 F 12/27/2000 A nurse reported that a 49 year old female received an injection of TD Toxoids Adsorbed, Purogenated on 7/26/00. Subsequently, she developed an injection site reaction characterized by "extreme" soreness and a "9cm line of discoloration down dorsi-lateral aspect" of upper arm. This is 1 of 4 pts from this facility who had an adverse experience following receipt of TD Toxoids Adsorbed, Purogenated lot 471038. U 07/26/2000 UNK OTH OTH UNK NONE Rhinitis, seasonal HQ0398029AUG2000 1
0170209 05/23/2001 TN 67 F 12/27/2000 A healthcare professional reported that a 67 year old female received an injection of TD Toxoids Adsorbed, Purogenated on 8/7/00. Within 24 hours, the pt developed an injection site reaction characterized by redness, swelling and warmth. The pt recovered. The reporter indicated that 4 pts experienced this event following receipt of TD Toxoids Adsorbed, Purogenated lot 471039; however, they are not presently identifiable. Additional reports will be generated when identifying information is provided. Y 08/07/2000 UNK PVT OTH UNK UNK UNK HQ0704706SEP2000 1
0170210 05/23/2001 MO 73.0 73 F 10/16/2000 A lab technician reported that a 73 year old female received an injection of TD Toxoids Adsorbed, Purogenated on 8/30/00. The next day, the pt developed an injection site reaction characterized by hardness, warmth and swelling. She was treated with applications of ice to the affected area. The reporter indicated that 4 pts experienced an adverse event; however, only 1 is presently identifiable. Additional reports will be generated when identifying information is provided. U 08/30/2000 08/31/2000 1 NONE OTH OTH Losartan Potassium; Simvastatin; sucralfate; alprazolam; lansoprazole UNK Cataract NEC; operation NOS; Hemorrhoids HQ0706506SEP2000 1
0170211 05/23/2001 IN U 01/08/2001 A pharmacist reported that a pt received an injection of TD Toxoids Adsorbed, Purogenated and subsequently developed a fever and a "severe" local reaction. No further information was available at the date of this report. The reporter indicated that 3 pts experienced this event following receipt of this vaccine, lot 471638; however, they are not presently identifiable. Additional reports will be generated when identifying information is provided. U UNK OTH OTH UNK UNK UNK HQ1300321SEP2000 1
0170212 05/23/2001 VA M 10/06/2000 A physician reported that a male received an injection of TD Toxoids Adsorbed, Purogenated and subsequently, the pt developed a fever and a rash. He also, developed swelling and redness at the injection site, lasting more than 4 days. The pt was treated by the physician for a dx of cellulitis. This is 1 of 2 pts from this facility who had an adverse experience following this vaccine, lot 470535. U 09/01/2000 UNK PVT OTH UNK UNK UNK HQ1484527SEP2000 1
0170213 05/23/2001 PA 50.0 50 M 10/16/2000 A purchasing agent reported that a 50 year old male received an injection of TD Toxoids Adsorbed, Purogenated on 7/11/00 and 7 days, post vax, the pt developed an injection site reaction. He was seen by a physician and recovered. This is 1 of 2 pts from this facility who developed an injection site reaction following receipt of this vaccine, lot 470531. Y Y 07/11/2000 07/18/2000 7 UNK PUB OTH UNK NONE UNK HQ1828105OCT2000 1
0170214 05/23/2001 VA M 10/10/2000 A physician reported that a male received an injection of TD Toxoids Adsorbed, Purogenated and subsequently developed a fever and rash. He also developed an injection site reaction characterized by redness and swelling, lasting for more than 4 days. This is 1 of 2 pts from this facility who had an adverse experience following receipt of this vaccine, lot 470535. U 09/01/2000 UNK PVT OTH UNK UNK UNK HQ1872106OCT2000 1
0170215 05/23/2001 GA U 12/29/2000 A physician reported that several pts received TD Toxoids Adsorbed, Purogenated and subsequently, developed cellulitis. The pts recovered. The reporter was unable to specify the number of pts who experienced this event. Additional reports will be generated when identifying information is provided. Y UNK PVT PVT UNK UNK UNK HQ2068811OCT2000 1
0170216 05/23/2001 GA U 10/17/2000 A physician reported that several pts received TD Toxoids Adsorbed, Purogenated and subsequently, developed injection site reactions characterized by redness, swelling and tenderness. As of 10/9/00, no further information was available. The reporter was unable to specify the number of pts who experienced this event. Additional reports will be generated when identifying information is provided. U UNK PVT PVT UNK UNK UNK HQ2272616OCT2000 1
0170217 05/23/2001 AZ 40.0 F 12/27/2000 A physician reported that a 40 year old female received an injection of TD Toxoids Adsorbed, Purogenated in 10/00. Subsequently, the pt experienced a "loss of strength in her right arm due to possible intratendinous or nerve injection". U 10/01/2000 UNK OTH OTH UNK "a cut" UNK HQ2609223OCT2000 1
0170218 05/23/2001 TX U 01/15/2001 A pharmacy technician reported that a pt received an injection of TD Toxoids Adsorbed, Purogenated and subsequently developed an injection site reaction which the reporter did not describe. No further information was available at the date of this report. This is 1 of 2 pts from this facility who had an adverse experience following receipt of TD Adsorbed, Purogenated, lot 471638. U UNK OTH OTH UNK UNK UNK HQ4223529NOV2000 1
0170219 05/23/2001 NY U 01/15/2001 A pharmacist reported that a pt received an injection of TD Toxoids Adsorbed, Purogenated on 11/15/00. On 11/26/00, the pt developed a rash on the hands and feet. The reporter indicated that a biopsy was performed. Based on the biopsy results, the physician determined that this event was related to vaccine administration. U 11/15/2000 11/26/2000 11 Biopsy NOS-results not provided OTH OTH UNK UNK UNK HQ4521006DEC2000 1
0170220 05/23/2001 TX F 12/15/2000 A nurse reported that a female received an injection of DT Toxoids Adsorbed, Purogenated on 8/18/00. On 9/05/00, she developed "extreme soreness" at the injection site. This is 1 of 4 pts from this facility who had an adverse experience following receipt of this vaccine, lot 471038. U 08/28/2000 09/05/2000 8 UNK OTH OTH UNK NONE UNK HQ4662908DEC2000 1
0170221 05/23/2001 TX 33.0 33 M 12/15/2000 A nurse reported that a 33 year old male received an injection of TD Adsorbed, Purogenated on 8/21/00. On 8/23/00, he developed an injection site reaction characterized by "extreme" pain, soreness, swelling and redness. The pt recovered. This is 1 of 4 patients from this facility who had an adverse experience following receipt of this vaccine, lot 471038. Y 08/21/2000 08/23/2000 2 UNK OTH OTH UNK UNK UNK HQ4663008DEC2000 1
0170222 05/23/2001 CA U 05/01/2000 A healthcare professional reported that a pt received an injection of TD Toxoids Adsorbed, Purogenated on 4/24/00 and subsequently developed injection site swelling described as the "size of a half dollar". This is 1 of 2 pts from this facility who developed injection site swelling following this vaccine, lot 465319. U 04/24/2000 UNK PVT PVT UNK UNK UNK HQ4918628APR2000 1
0170223 05/23/2001 CA U 05/01/2000 A healthcare professional reported that a pt received an injection of TD Adsorbed, Purogenated on 4/27/00 and subsequently developed injection site swelling described as the "size of a half dollar". This is 1 of 2 pts from this facility who developed injection site swelling following receipt of this vaccine, lot 465319. U 04/27/2000 UNK PVT PVT UNK UNK UNK HQ5028301MAY2000 1
0170224 05/23/2001 FL M 01/08/2001 A nurse reported that a male received an injection of TD Toxoids and subsequently developed an injection site reaction characterized by redness and soreness. He recovered. Y UNK OTH OTH UNK UNK UNK HQ5436402JAN2001 1
0170225 05/23/2001 TX U 01/15/2001 A pharmacy technician reported that a pt received an injection of TD Toxoids Adsorbed, Purogenated and subsequently developed generalized hives. The pt also developed an injection site reaction which the reporter did not describe. No further information was available at the date of this report. This is 1 of 2 pts from this facility who had an adverse experience following receipt of this vaccine, lot 471638. U UNK OTH OTH UNK UNK UNK HQ5446302JAN2001 1
0170226 05/23/2001 10.0 M 07/20/2000 A mother reported that her 10 year old son received an injection of TD toxoids and immediately developed an injection site reaction characterized by a 4" wide area of induration and redness, lasting 1 week. The child subsequently, developed a hard nodule at the injection site. The mother reported that her son has "various unnamed allergies", possibly including eggs. The reporter declined to provide further information and declined to grant permission for follow-up investigation. U UNK OTH OTH UNK UNK Hypersensitivity NOS HQ5900315MAY2000 1
0170227 05/23/2001 OH F 07/12/2000 A physician reported that a female in her 60's with a history of arthritis, received an injection of TD Toxoids Adsorbed, Purogenated. She was receiving therapy with Mevacor at the time of the immunization. One to two days later, she developed myalgia of the proximal muscles in her extremities. She also developed an injection site reaction characterized by redness and tenderness. N 04/01/2000 04/02/2000 1 UNK PVT OTH Mevacor, Restoril, Synthroid, Allopurinol, Elavil UNK Arthritis NOS HQ6024517MAY2000 1
0170228 05/23/2001 MI 24.0 24 F 10/25/2000 A nurse reported that a 24 year old female sustained a puncture wound to her hand and received an injection of TD Toxoids Adsorbed, Purogenated on 5/27/00 as part of wound management. On 5/29/00, the pt developed a fever of 103F, hives on the back of her legs, nausea and vomiting, and a "severe" injection site reaction characterized by redness, swelling and itching. The pt was seen by the physician and treated with IM diphenhydramine and oral prednisone. This is 1 of 3 pts from this facility who had an adverse experience following receipt of this vaccine, lot 470536. Y U 05/27/2000 05/29/2000 2 UNK PUB PVT Effexor; oral contraceptive NOS Puncture wound to hand UNK HQ6818102JUN2000 1
0170229 05/23/2001 CO U 06/14/2000 A pharmacist reported that a pt received an injection of TD Toxoids Adsorbed, Purogenated and subsequently, developed a injection site reaction characterized by swelling and hardness and described as "looks like a boil". As of 6/11/00, the symptoms persisted. This is 1 of 3 pts from this facility who experienced this event following receipt of this vaccine, lot 471039. The reporter indicated that 3 pts experienced this event; however, they are not presently identifiable. Additional reports will be generated when identifying information is available. U UNK PVT OTH UNK UNK UNK HQ7220213JUN2000 1
0170230 05/23/2001 LA 29.0 29 F 07/20/2000 A pharmacist reported that a 29 year old female received an injection of TD Adsorbed, Purogenated on 6/7/00. The pt received vaccine either from lot 462364 or 464259. She subsequently, developed an injection site reaction characterized by redness, swelling and pain. On 6/12/00, the pt was seen by the physician and the reaction had resolved by that date. Y Y 06/07/2000 UNK PVT OTH UNK UNK UNK HQ7542820JUN2000 1
0170231 05/23/2001 MI 36.0 36 F 07/25/2000 A nurse reported that a 36 year old female received an injection of Tetanus Diphtheria Toxoids Adsorbed, Purogenated on 05/27/00. On 05/29/00, the patient developed a "severe" injection site reaction characterized by pain, warmth, and swelling. The patient was seen by a physician and treated with Prednisone and a methylprednisolone pack. This is 1 of 3 patients from this facility who had an adverse experience following receipt of Tetanus Diphtheria Toxoids Adsorbed, Purogenated lot # 470-536. Y U 05/27/2000 05/29/2000 2 UNK PUB PVT Carbamazepine, Famotidine. NONE UNK HQ7652221JUN2000 1
0170232 05/23/2001 MI 28.0 28 U 07/25/2000 A nurse reported that a 28 year old patient received an injection of Tetanus Diphtheria Toxoids Adsorbed, Purogenated on 05/27/00. On 05/29/00, the patient developed a "severe" injection site reaction characterized by an area of redness, and induration measuring 2 inches by 1 inch. The patient was seen by the physician and treated with diphenhydramine, Prednisone, and Cephalexin. This is 1 of 3 patients from this facility who had an adverse experience following receipt of Tetanus Diphtheria Toxoids Adsorbed, Purogenated lot # 470-536. Y U 05/27/2000 05/29/2000 2 UNK PUB PVT Ibuprofen NONE UNK HQ7652321JUN2000 1
0170233 05/23/2001 OH 15.0 U 07/20/2000 A nurse reported that a 15 year old patient received an injection of Tetanus Diphtheria Toxoids Adsorbed, Purogenated on 06/09/00. The next day, the patient developed an injection site reaction characterized by erythema, and swelling. The patient also felt achy and light-headed. A few days later, the patient developed welts at the injection site. After the welts abated, the site became indurated. This is 1 of 2 patients from this facility who had an adverse experience following receipt of Tetanus Diphtheria Toxoids Adsorbed, Purogenated lot # 468-868. U 06/09/2000 06/10/2000 1 UNK OTH OTH Albuterol NONE Asthma. HQ7826526JUN2000 1
0170234 05/23/2001 KY 39.0 39 U A nurse reported that a 39 year old patient received an injection of Tetanus Diphtheria Toxoids Adsorbed, Purogenated on 06/16/00 and subsequently developed an injection site reaction characterized by redness, warmth, and swelling. The reaction persisted for at least 1 week. This is 1 of 3 patients from this facility who developed an injection site reaction following receipt of 2 different lots of Tetanus Diphtheria Toxoids Adsorbed, Purogenated. U 06/16/2000 UNK PVT OTH UNK Skin wound. UNK HQ7829226JUN2000 1
0170235 05/23/2001 KY 23.0 23 U A nurse reported that a 23 year old patient received an injection of Tetanus Diphtheria Toxoids Adsorbed, Purogenated on 06/18/00 and subsequently developed an injection site reaction characterized by redness, warmth, and swelling. The reaction persisted for at least 1 week. This is 1 of 3 patients from this facility who developed an injection site reaction following receipt of 2 different lots of Tetanus Diphtheria Toxoids Adsorbed, Purogenated. U 06/18/2000 UNK PVT OTH UNK Skin wound. UNK HQ7854526JUN2000 1
0170236 05/23/2001 KY 66.0 66 U A nurse reported that a 66 year old patient received an injection of Tetanus Diphtheria Toxoids Adsorbed, Purogenated on 06/14/00 and subsequently developed and injection site reaction characterized by redness, warmth, and swelling. The reaction persisted for at least 1 week. This is 1 of 3 patients from this facility who developed an injection site reaction following the receipt of 2 different lots of Tetanus and Diphtheria Toxoids Adsorbed, Purogenated. U 06/14/2000 UNK PVT OTH UNK Puncture wound. UNK HQ7854626JUN2000 1
0170237 05/23/2001 PA 76.0 76 F 10/03/2000 A nurse reported that a 76 year old female received an injection of Tetanus Diphtheria Toxoids Adsorbed, Purogenated on 07/06/00, and subsequently developed an injection site reaction characterized by redness, soreness, and warmth. This is 1 of 2 patients from this facility who developed an injection site reaction following receipt of Tetanus and Diphtheria Toxoids Adsorbed, Purogenated lot #471-637. U 07/06/2000 UNK PVT PVT UNK UNK UNK HQ8388811JUL2000 1
0170238 05/23/2001 PA 73.0 73 F 10/13/2000 A nurse reported that a 73 year old female received an injection of Tetanus Diphtheria Toxoids Adsorbed, Purogenated on 07/03/00. On 07/06/00, she developed an injection site reaction characterized by soreness, swelling, redness, and warmth. A diagnosis of cellulitis was made. This is 1 of 2 patients from this facility who developed an injection site reaction following receipt of Tetanus and Diphtheria Toxoids Adsorbed, Purogenated lot # 471-637. U 07/03/2000 07/06/2000 3 UNK PVT PVT Calcium, Zocor. UNK UNK HQ8398411JUL2000 1
0170239 05/23/2001 WI F 09/08/2000 A physician reported that a female received Tetanus and Diphtheria Toxoids Adsorbed and subsequently, developed a "severe" allergic reaction. No further information was available as of 07/11/00. Additional information received on 08/28/00 from the reporting physician, indicated that the event had occurred "many years ago" and no further information was available. U UNK OTH OTH UNK UNK UNK HQ8434412JUL2000 1
0170240 05/23/2001 PA 16.0 16 F 10/03/2000 A nurse reported that a 16 year old female received an injection of Tetanus Diphtheria Toxoids Adsorbed, Purogenated on 06/28/00. On 07/01/00, he developed an injection site reaction characterized by redness, swelling, and pain. She was treated with Ibuprofen, diphenhydramine, an antibiotic, and application of ice. As of 07/13/00, the patient had improved. U 06/28/2000 07/01/2000 3 UNK PVT OTH NONE NONE UNK HQ8538114JUL2000 1
0170241 05/23/2001 PA 64.0 64 F 10/17/2000 A purchasing agent reported that a 64 year old female received an injection of Tetanus and Diphtheria Toxoids Adsorbed, Purogenated and subsequently developed an injection site reaction. The patient was seen in the ER and recovered. This is 1 of 2 patients from this facility who developed an injection site reaction following receipt of Tetanus and Diphtheria Toxoids lot # 470-531. Y Y 06/23/2000 06/23/2000 0 UNK PUB OTH UNK NONE UNK HQ8819521JUL2000 1
0170242 05/23/2001 TX 11.0 11 M 08/15/2000 A nurse reported that an 11 year old male received Tetanus and Diphtheria Toxoids Adsorbed, Purogenated and Engerix-B vaccines on 08/04/00. On 08/06/00, he developed a rash on both hands and a 3 to 4 inch area of redness at the site of Tetanus and Diphtheria Toxoids administration. He was noted to be improving on 08/08/00. This is 1 of 2 patients from this facility who developed an injection site reaction following receipt of Tetanus and Diphtheria Toxoids Adsorbed, Purogenated. A copy of this report has been forwarded to SKB, manufacturer of Engerix-B. U 08/04/2000 08/06/2000 2 UNK PVT OTH NONE NONE UNK HQ9632609AUG2000 1
0170243 05/23/2001 TX 14.0 14 U 08/15/2000 A nurse reported that a 14 year old patient received an injection of Tetanus and Diphtheria Toxoids Adsorbed, Purogenated on 08/04/00. On 08/06/00, the patient developed redness at the injection site. This is 1 of 2 patients from this facility who developed an injection site reaction following receipt of Tetanus Diphtheria Toxoids adsorbed, Purogenated. U 08/04/2000 08/06/2000 2 UNK PVT OTH NONE NONE UNK HQ9851215AUG2000 1
0170248 05/24/2001 PA 41.0 41 F 08/03/2000 A nurse reported that a 41 year old female received an injection of Tetanus and Diphtheria Toxoids Adsorbed, Purogenated on 06/30/00 as part of wound management following a cat bite. The patient also received therapy with Amoxicillin / Clavulanate. On 07/06/00, the patient was seen by the physician, who diagnosed cellulitis at the Tetanus and Diphtheria Toxoids injection site. The patient was hospitalized. Follow up info received 08/02/00 indicated that the patient recovered. MANUFACTURER'S COMMENT: On the following up, the reporter indicated that 2 additional patients developed cellulitis following receipt of Tetanus and Diphtheria Toxoids adsorbed, Purogenated; however, the report did not identify these patients. Neither of them was hospitalized. Y Y Y 06/30/2000 07/06/2000 6 UNK PVT PVT Amoxicillin w/ Clavulanate Potassium. Cat bite UNK HQ8372111JUL2000 1
0170249 05/24/2001 CA 0.2 0 .2 M 05/03/2001 Child was at Disneyland with family; paramedics were called. The child died. This is a coroner case. No other details are available to us at this time. Y 04/14/2001 N 04/13/2001 04/14/2001 1 NONE OTH PUB NONE NONE NONE 1
0170257 05/24/2001 FL 3.0 3 M This child had cellulitis on his right leg 4 inches in diameter. Also with an area of ulceration and blister on the center. Y 2 Y 04/09/2001 04/10/2001 1 CBC-nml; Cultures-neg PVT PVT NONE NONE 1
0170258 05/24/2001 FL 35.0 35 M 05/11/2001 This patient had multiple joint pain in Dec 00. Diagnosed with rheumatoid arthritis after the 4th Anthrax injection. Y N 03/29/2000 12/01/2000 247 MIL MIL NONE NONE NONE 1
0170259 05/24/2001 IA 29.0 29 F 04/20/2001 On 9/19/91 (age 29) I was injected with my 1st Hep-B vaccine. This was my 1st (and ultimately, only) of a 3 injection series for Hep-B protocol. I have never been healthy since this injection. 'Insult was added to injury' when I had to receive a mandatory MMR. On 9/21/91, just 2 days after my Hep-B vaccination, I experienced significant fatigue and malaise. I had an oral temperature of 99.8F. I developed nausea, vomiting and diarrhea. At this time, I thought I just had the flu. This continued off and on for the next several months. I missed a significant number of work days. On 10/3/91, 14 days, post vax, I went to the outpatient clinic with an extreme sore throat. My tonsils were quite swollen. I told the doctor that I had fatigue that was worse than the sore throat, that seemed nearly incapacitating. He told me that that was actually 'good' because my body was busy fighting the infection. He gave my oral penicillin. As you will see, this sore throat and exaggerated fatigue were in reality, undiagnosed mononucleosis. I called and talked to the nurse and she assured me that I could not be ill from the Hep-B vaccination because it was not a 'live' virus that was injected. I believe she was telling me what she believed to be true. I suspect that she did not know about any long term adverse reactions or side effects related to Hep-B. I didn't either, and I was also a nurse. In 10/91, I also began developing severe headaches and they continue to this day. My fatigue continued on and I felt like a zombie, but I continued on with my contract and pushed myself through my shifts. I began using a lot of caffeine in large quantities, to give me enough energy to get through my work hours. I slept excessively during my time off work. In 12/91, I drove to my parents home in Iowa and nearly immediately became very ill. I developed a severe 'flu' with more vomiting and diarrhea so severe, I began having bloody diarrhea. I was too weak to do anything. On 1/7/91, I received a mandatory MMR. I was told that I had to have one in order to work. I refused the Hep-B #2 but the nurse urged my to have it. I refused over and over again and did not allow myself to be given the Hep-B. As soon as the MMR needle entered my body, my entire muscle in my upper left arm went into a severe spasm. The nurse told me to relax my arm and I told her it was relaxed. Within 2 weeks, post vax, I developed extremely sore knees. My headaches worsened and now my neck was stiff with these excruciating headaches. I went to a health food store and bought a product to help give me energy called 'EXCEL'. My throat would become sore with my lymph nodes enlarging when I exerted myself (like at work). I had a nearly continuous low-grade fever of 99.2F-100.6F that would come down when I was rested, but it returned with minimal exertion. Next, I began having intermittent blurred vision in my right eye which lasted approx. 6 months. I remember the numbness in my arms and legs worsening. One day I went for a walk with a friend and ended up hysterically crying because I was having a great deal of difficulty walking. I went to a health clinic and was seen by a NP and she evaluated me and after a coupe more difficult weeks, she dx'd me as having mononucleosis which I, myself, had suspected back on 10/3/91. I didn't get better. I remember the NP telling me that I probably had chronic fatigue syndrome also known as chronic fatigue and immune dysfunction syndrome and myalgic encephalomyelitis. My medical records from 4/92, document the onset of my illness associated with the Hep-B vaccination 9/91 and worsening considerably after the mandatory MMR in 1/92. This information again, confirms the unawareness of vaccination injury inside the 'educated and informed' medical community. My overall health has deteriorated and left me completely disabled. I have been living on SSD which you may know is significantly limiting and leaves me completely financially controlled. I have lost a huge amount of my hair, am physically restricted and mainly homebound with significant cognitive dysfunction. I rely on prescription amphetamines in order to think and communicate properly. I continue to have exaggerated fatigue, weakness, migraines, frequent infections, osteoporosis by the age of 34 years, generalized muscular fasiculations, thyroid disorder and an autoimmune disorder. The annual follow-up states "exhaustion, weakness, activity intolerance, alopecia, cognitive dysfunction, muscle cramps and muscle twitching, sudden eipsodes of needing to lay flat. Unable to sit or stand for a predictable time. Frequent infections, osteoporosis, migraines, numbness of extremities. Heat and cold intolerance, insomnia." Medical records repeatedly indicate associated illness/disability with this vaccination. Y N 09/19/1991 09/21/1991 2 UNK PVT UNK Birth control pills, Ortho-Novum 777 NONE NONE 1
0170260 05/24/2001 IA 29.0 29 F 04/20/2001 The pt experienced worsening fatigue, frequent sore throats with elevated temps from 99-100, very sore joints especially knees, blurred vision in right eye. Onset within 10 days post vax. The pt also experienced difficulty walking, unable to continue working. Treatment was rest. The pt also had severe headaches.Doc 197456 received on 08/15/2001,reports the followings: frequent infections, severe cognitive impairment, transient memory loss and forgetfulness. Abnormal EEG and sleep study. Paraesthesias plus babinski's. Hypersomnia alternating with insomnia. Low endurance threshold, exercise intolerance, muscle cramps, restless leg syndrome. Migraines. Athralgias. 8 years of positive mononuclosis (Mono Spots), elevated EBV titers. Debilitating exhaustion. No signs of recovery, completely disabled after vaccination injuries. The annual follow-up states "activity intolerance, cognitive dysfunction, muscle twitching and cramping, frequent infections, insomnia and sleep deprivation, exhaustion. Unable to sit upright or stand for more than 0-6 hours per 24 hrs, freq episodes of having to lay flat numbness in extremities, osteoporosis, alopecia. This was "mandatory" vaccine for employment purposes. At the time of this vaccination the pt complained of being unwell since the hep B vaccine received 3 months earlier 9/19/91. The pt's health declined significantly after receiving this vaccine. Y N 01/07/1992 01/19/1992 12 (+) mononucleosis in 5/92 (I suspect it was undiagnosed since 10/91); WBC: 6.4; RBC COUNT: 4.36; HEMOGLOBIN: 13.8; HEMATOCRIT: 39.4; MCV: 90.3; MCH: 31.7; MCHC: 35.1; RDW: 12.6; PLATELETS: 320; MPV: 7.7; LYMPH %: 37.3; MONO %: 4.1; GRAN %: 58.6; WBC'S COUNTED: 100; POLYMORPHS: 54; LYMPHOCYTES: 39; MONOCYTES: 4; EOSINOPHILS: 1; BASOPHILS: 1; ATYP LYMPHS: 1; HBV S AB: NEGATIVE; RUBELLA SCREEN: IMMUNE; ALK PTASE: 46; GOT: 17; GPT: 6; GGTP: 10; URINE: COLOR: YELLOW: APPEARANCE: CLEAR: SPEC GRAV: 1.024; PH: 5.0; PROTEIN: NEGATIVE; GLUCOSE: NEGATIVE; KETONE: NEGATIVE; UROBILINOGEN: 0.1; HEMOGLOBIN: NEGATIVE; BILIRUBIN: NEGATIVE; NITRITE: NEGATIVE; L ESTERASE: NEGATIVE; ASCORBIC ACID: 2+; PVT UNK NONE Reaction unevaluation~Hep B (no brand name)~1~29.00~In Patient 1
0170261 05/24/2001 NC 1.2 1 .2 M 05/11/2001 The pt experienced a seizure immediately following MMR vax at the age of 1.2 years of age. Hospitalization after valium administration. Y 2 Y 11/12/1997 11/12/1997 0 MRI head, EEG - nml PVT PUB NONE NONE NONE NC01050 1
0170262 05/24/2001 MN 2.0 1 1 F 05/14/2001 The pt experienced a pinpoint rash on trunk starting evening of 5/9/01. Fever starting on 5/10/01. Y 05/09/2001 05/09/2001 0 Group A rapid strep - neg PVT UNK NONE NONE 1
0170263 05/24/2001 OH 2.0 2 .2 F 05/15/2001 The pt was up all night with leg pain from the Prevnar vaccine. The leg was swollen and the pt had a high fever, was crying, won't walk on leg, just lying down. Site doesn't really look too red. U 05/14/2001 05/14/2001 0 PVT PVT NONE NONE NONE 1
0170264 05/24/2001 OH 2.0 2 .7 F 05/17/2001 The pt experienced erythema and firmness at the site the evening of the vax. Returned to the office with increasing erythema. Y 05/15/2001 05/15/2001 0 NONE PVT PVT Zyrtec Clear runny nose constipation, RAD, frequent OM 1
0170265 05/24/2001 OH 0.5 0 .5 F 05/18/2001 Mom called stating the child received immunizations and that night woke up at 1:30 am crying and has not stopped. When asked stated warm, but was unaware of temp. Stated very warm last night. Pt is receiving Tylenol. U 05/10/2001 05/11/2001 1 PUB PUB 1
0170266 05/24/2001 CA 2.0 1 .5 F 05/16/2001 Mother noted intermittent head shaking and head jerking, starting 2 days, post vax. At first occurred multiple times a day, for a few seconds, then gradually became less frequent and occurred about 2 X a day, especially when tired. Resolved after a few months. ? involuntary. Reaction brought to my attention at 2 year visit and it had resolved. Y 11/21/2000 11/23/2000 2 NONE PVT PVT NONE NONE NONE 1
0170267 05/24/2001 MD M 05/22/2001 On an unspecified date, the pt received a dose of Lymerix; it is not known whether the pt had received prior injections of Lymerix. Reportedly, after a "few" months, the vaccinee developed "severe joint and muscle pain and stiffness". The physician "did not give me any further shots." Reportedly, the physician treated the pt with ibuprofen 400mg three times daily. As of 5/15/01, the adverse events were unresolved. N OTH OTH 20010124851 1
0170268 05/24/2001 CT 38.0 38 F 05/22/2001 "Two years ago", in 5/99, the vaccinee received her 1st dose of Lymerix, without adverse event. "One month later", in 6/99, she received her 2nd dose of Lymerix. "Two months later", in 8/99, the pt experienced joint pain in her neck, spine, wrists, feet, hips and shoulders. A doctor visit was required. The pt stated that her physician had suggested that she had osteoarthritis. X-rays were performed. The pt spoke with the radiologist, who reportedly told her that she did not have osteoarthritis. Multiple sets of unspecified lab tests were performed, and the pt stated that they all came back "unremarkable." As of 5/16/01, the outcome of the event is unresolved. The follow-up states that she had arthralgia in the knees in 1995. At that time her Lyme titer was negative. There was no illness at the time of vaccination. The vaccinee's mother had osteoarthritis in her fifties. On 05/18/1999, she received her second dose of LYMErix. Five months later on 10/05/1999, the vaccinee experienced joint pain in her hands, neck, spine, wrists,feet, hips, and shoulders. The pt was treated on 11/22/1999 with aspirin, ibuprofen and glucosamine/chondroitin. The LYMErix immunizatin series was discontinued due to the adverse event. The reporting physician stated that the adverse event was mild in intensity and was possibly related to LYMErix. However, he reported that it could also be associated with the pt's family history of osteoarthritis. As of 06/22/2001, the event was ongoing. Y N 05/18/1999 10/05/1999 140 X-rays; lab tests PVT PVT NONE Arthralgia (knee) 20010125271 1
0170269 05/24/2001 PA 36.0 36 M 05/22/2001 On an unspecified date, the pt received a dose of Lymerix, it is not known if he had received previous doses of Lymerix. Subsequently, the pt reportedly, developed rheumatoid arthritis, which the reporter described as "severe". As of 5/16/01, the outcome of the adverse event was unknown. Report 2001012530 describes rheumatoid arthritis in a 36 y.o. male who received Lyme disease vaccine recombinant OspA (LYMErix). This report was received as part of litigation proceedings, w/forwarding of medical records. *The subject's medical history included allergy to cats, kidney stones (85), fractured right knee and chipped patella due to a motor vehicle accident (86), rectal bleeding (96), diverticulitis (96), tick exposure, chronic bronchitis, and "rare" mariajuana use. There were no concurrent medications.* The vaccinnee received injections of LYMErix *on 5/3/99, 6/7/99, and 7/17/00.* "In early 2001", the vaccinee "began experiencing extreme pain and suffering in the joints and in his body." The vaccinee allegedly developed severe Rheumatoid Arthritis [sic] or a type of treatment-resistant Lyme Disease [sic]. It was further alleged that he has been unable to perform his usual duties and occupations, and has been unable to go about his usual activities. his attorney stated, "(The vaccinee) has been advised that his condition is permanent." The most recent information was received on 09 November 2001. Since the vaccinee allegedly has been unable to perform his usual duties and occupations, and has been unable to go about his usual activities, he is considered to be disabled. Therefore, this report has been reclassified as serious. *F/UP report on 3/3/03: The following info was obtained from medical records. The subject presented to the vax provider on 1/11/01 w/complaints of pain in the feet and neck stiffness. The MD noted decreased range of motion of the cervical spine. The MD's impression was "Fascitis of both feet. Cervical strain." The MD prescribed a rapidly-tapering course of mathylprednisolong (Medrol Dosepak) and celecoxib (Celebrex). On 1/23/01, x-rays of both feet were negative. The subject remained under the care of the vaccine provider until at least 5/9/02. On 3/13/01, he reported "All joints involved. Taking colchicine, but feet still hurt." On 3/13/01, the MD noted swelling of the right hand w/decreased grasp. On 5/9/02, the MD observed "trigger finger". Lab analyses performed on 3/13/01 revealed abnormalities. X-rays performed on 3/26/01 did not reveal abnormalities. Lyme IgG Western blot was Neg. on 6/18/01. Please Lab Data section. The MD made Dx's of osteoarthritis (3/13/01) and rheumatoid arthritis (4/12/01). Pharmacy records indicated that this MD prescribed dextropropoxyphene napsylate/ paracetamol and furosemide. As of 5/9/02, the rheumatoid arthritis persisted, and the vaccine provider referred the subject to a rheumatologist at a tertiary care center. The subject was evaluated by a rheumatologist on 4/5/01. At that time, he reported that he had been experiencing difficulty walking secondary to pain, swelling, and stiffness since Dec. 00. He stated that he then experienced left shoulder bursitis. He also reported that he developed intermittent swelling on his chest and progressively worse pain, swelling, and stiffness of his knees, hands, and wrists. These Sx's got "better as day goes". He reported "several hours" of morning stiffness. The rheumatologist's impression was "Rheumatoid Arthritis - seropositive." He prescribed hydroxychloroquine (Plaquenil) and naproxen (Naprelan); celecoxib therapy was discontinued. The subject remained under the care of this rheumatologist until 7/9/01. During this time, he reported neck pain, hand pain and swelling, and "stiffness all day". He also reported that his right knee, ankles, and toes were "difficult w/activity". The subject reported "good and bad days" and stated that physical therapy and occupational therapy were "Helpful with strength." During this time, the rheumatologist observed good range of motion of the cervical spine; full range of motion of the shoulders, elbows, hips, and anlkes; decreased range of motion "finger to palm"; warmth and a small effusion in the left knee; synovial swelling, thickening, and tenderness of the metacarpophalangeal, proximal interphalangeal, and metararsophalangeal joints; and flexor tendonitis of the right 5th finger. Naproxen therapy was discontinued. In addition to continuation of hydroxychloroquine therapy, the rheumatologist prescribed celecoxib, methotrexate, a soft neck collar, physical therapy and occupational therapy. The subject was evaluated by a physical therapist on 5/29/01. The subject reported that he experienced pain ranging from 0 to 7, on a scale of 0-10. He reported 5/10 pain at the time of evaluation. He reported that the pain increased w/activity, and decreased w/rest and showeing. He reported walking tolerance of two hrs. He stated his goal for physical therapy as "Back to being a normal person. To be medication free." The therapist noted swelling of the digits on both hands, decreased range of motion in the hands and feet, decreased strength - left greater than right, and decreased function. Using the General Pain Disability Index Questionnaire, the subject scored 78%, which the therapist recorded as "crippling disability". However, the therapist noted that the subject was still working, "doing modified duty." The therapist's treatment plan included paraffin, active range of motion, isotonics, aquatic exercises, and a home exercise program. The rehab potential was recorded as "good". The subject attended 14 sessions of physical therapy from 5/30/01 'til 7/20/01. Because hand and digit pain did not initially respond, the therapist added ultrasound therapy. By 6/15/01, the subject had experienced "Good improvements in strength. Pain seems much improved w/change in medication." The subject's score on the General Pain Disability Index was 35%, which the therapist recorded as "moderate disability". On 7/20/01, the therapist wrote, "Pt relays pain is much improved. Able to stand for 4 to 5 hrs at one time." The subject's score on the General Pain Disability Index was 25%, which the therapist recorded as "moderate disability". The therapist wrote, "All goals met. PT instructed in home exercise program and water exercises if able to find pool. Recommend discharge to home exercise program." The subject was evaluated by an occupational therapist on 6/3/01. The therapist "Observed difficulty w/pinching, cutting, opening containers. Difficulty w/tool utilization/ wringing. Decreased knowledge of joint protection/ joint conservation." Upon examining the right hand, the therapist observed "Mild enlargement of first MP [metacarpophalangeal]/ second MP, mild laxity to ulnar deviation." The therapist wrote, "symptomatic bilateral right greater than left hand/ joint stiffness, decreased ability to complete dexterous/ prehensile tasks, decreased knowledge of joint protection. Education completed on joint conservation / protection w/application to self care, work, leisure tasks. Also educated on tendon gliding and hand ROM tasks... No further need for O.T. [occupational therapy]. Has written handouts / HEP (home exercise program)." The subject was evaluated by a 2nd theumatologist on 7/11/01. At that time, the subject reported hi chief complaints as "RA [rheumatoid arthritis] is affecting my ability to have a normal life - hands, feet, knees - pain and stiffness. He reported a 6-month history of pain. Medications at the time of the evaluation included celecoxib and hydroxychloroquine. On physical exam, the rheumatologist noted synovitis of metacarpophalangeal joints, proximal interphalangeal joints, and the wrists. Tenderness of metatarsophalangeal joints was also observed. The rheumatologist made Dx's of "RA. ? Lyme vax reaction." He prescribed methotrexate and methylprednisolone (Medrol). The subject remained under the care of this rheumatologist until at least 7/1/02. The subject reported diffuse arthralgias and myalgias, aching type pain that improved w/rest, fatigue, and poor sleep. The rheumatologist noted that the subject also reported "cognitive deficit?" on 12/11/01, the subject reported that after discontinuing methylprednisolone therapy, he experienced "immediate return of diffuse arthralgias in neck, wrists left greater than right, knees, anlkes. Positive response to restart of Medrol." During this time the rheumatologist noted persistent stiffness and decreased range of motion of the digits on both hands, antalgic gait, and ulnar deviation of the right 2nd and 3rd metacarpophalangeal joints. Lab analyses performed on 2/5/02 revealed abnormalities. Please see Lab Data section. The rheumatologist recorded the subject's prognosis as "fair". He prescribed applications of heat, stretching, and aerobic exercise. On 7/1/02, he recommended that the subject add etanercept (Enbrel) or infliximab (Remicade) to the therapeutic regimen. The subject underwent a rehab hand evaluation on 8/6/02. At that time, the subject reported the onset of foot pain as 10/1/00. He reported difficulty gripping and pulling objects. The subject stated his goal for treatment as "Fix right hand." Medications at the time of evaluation included hydroxychloroquine, methotrexate, methylprednisolone, and celecoxib. The therapist observed decreased function, decreased range of motion, decreased strength, pain, and ulnar deviation. The therapist recorded "minimal" restriction in activities of daily living, "moderate" work restriction, and "severe" sport restriction. The therapist recommended range of motion exercises, pain control, "MH [moist heat]/ paraffin/ ice", possible splinting to great ulnar deviation, and a home program. The rehab potential was recorded as "Good". Following the reported onset of rheumatoid arthritis, the subject experienced a kidney stone w/hydronephrosis, possible cholelithiasis, and a ganglion cyst on the right wrist. These events were not reported as adverse events due to vax admin, but were found during the course of review of the subject's medical records. Therefore, they are not listed as adverse events. Info. received on 11/9/01 indicated that since the vaccinee allegedly "has been unable to perform his usual duties and occupations, and has been unable to go about his usual activities", he is considered to be disabled. Therefore, this report has been reclassified as serious. Info received on 11/15/02 indicated that the rheumatoid arthritis persisted as of 8/6/02. The most recent info, received on 1/8/03, did not provide the outcomes of the reported events.* Follow up on 02/26/04: "The most recent information, received on 05/12/03, indicated that the rheumatoid arthritis persisted as of March 2003. The outcome of the possible Lyme disease was not reported." Y Y N 07/01/2000 12/01/2000 153 Antinuclear antibody, 3/13/01, result < 1:40, range < 1:40; Blood uric acid, 3/13/01, result 4.8 mg/dL, range 4.0-8.5; C-reactive protein, 2/5/02, result 4.88 mg/dL, range 0-0.9; Eosinophil count, 3/13/01, result 1649 cells/cu mm, range 50-550; Erythrocyte sedimentation rate, 3/13/01, result 10 mm/hr, range 0-15; Erythrocyte sedimentation rate, 2/5/02, result 22 mm/hr, range 0-10; Erythrocyte sedimentation rate, 6/18/02, result 1 mm/hr, range 0-15; Rheumatoid factor, 3/13/01, result 148 IU/mL, range 39-80; Rheumatoid factor, 2/5/05, result Negative; Urine and blood cells increase, 2/5/02, result 10-15 cells, range 0-2; WBC count, 3/13/01, result 9700 cells/cu mm, range 3800-10800; X-rays feet, 1/23/01 - "Negative bilateral feet"; Lyme antibody screen, 3/13/01, 2.0 (Pos, >/= 1.20); Lyme IgG Western blot, 3/13/01, Neg, 31 kD band present; Lyme IgM Western blot, 3/13/01, Neg, 23 and 23 kD bands present; X-rays hands, 3/26/01, "An acute displaced fracture is not seen. Alignment appears anatomic. The joint spaces appear well preserved. Arthropathy is not seen. Specifically, the characteristic findings of rheumatoid arthritis are not seen"; X-rays knee, 3/26/01, "An acute displaced fracture is not seen. Significant degenerative changes are not seen, either"; Lyme IgG Western blot, 6/18/01, Neg. OTH OTH Frusemide UNK Cat allergy, chronic bronchitis, diverticulitis, kidney stone, knee fracture, marijuana use, motor vehicle accident, rectal bleeding, tick bites. 20010125301 1
0170270 05/24/2001 PA 4.0 4 F 05/16/2001 The pt experienced a red patch at the injection site. Had also complained of arm pain 6 hours post vax. Y U 05/14/2001 05/15/2001 1 PVT PVT Tylenol NONE NONE 1
0170271 05/24/2001 PA 1.3 1 .4 M 05/15/2001 1cm local reaction with red erythema and central pallor and pain. Altered mental status and ataxia and weakness, irritable and floppy. Referred for urgent neurology consult. Throat culture was negative. Y Y 04/30/2001 04/30/2001 0 Throat culture-neg; Neurology consult referral PVT PVT Tylenol Fever on 4/29/01 1
0170272 05/24/2001 CA 22.0 22 F 05/16/2001 Lips got swollen and "itchy" and "tingles"; felt a little "dizzy". Y 05/16/2001 05/16/2001 0 OTH UNK NONE States she has some type of allergies in the house she is staying in (unknown). 1
0170273 05/24/2001 TX 21.0 21 F 05/14/2001 Red, swollen, warm and tender mass, 8cm raised by 1cm on lateral right arm by 3rd day, post vax. Y U 05/07/2001 05/10/2001 3 NONE PVT UNK Cold/URI Allergic rhinitis; asthma; mental retardation 1
0170274 05/24/2001 PA 6.0 0 1 F 05/21/2001 Chickenpox, despite vaccine. U 02/19/1996 05/19/2001 1916 PVT UNK 1
0170275 05/24/2001 MA 4.0 4 M 05/17/2001 Swollen, red and warm left shoulder with 5-7cm of erythema. U 05/14/2001 05/15/2001 1 PVT UNK NONE NONE 1
0170277 05/24/2001 NC 1.25 1 .3 M 05/23/2001 4 1/2" X 4" local reaction which mom noticed on 5/23/01 at 08:30. U 05/22/2001 05/23/2001 1 NONE PVT PUB NONE NONE NONE 1
0170278 05/24/2001 KY 1.6 1 .6 M 05/21/2001 Night of vaccines, 5/16/01, spiked a fever to 103.4F and developed "grunty" breathing. Had a red, blotchy rash on body. Was seen in ER that night and dx'd with bronchitis and given IM Rocephin. Seen by PMD on 5/17/01 and was told it was "moderate reaction" to pertussis. Mother said he was better by 5/17/01. Y Y 05/16/2001 05/16/2001 0 PUB PUB NONE NONE KY2001035 1
0170279 05/24/2001 RI 1.25 1 .3 M 05/16/2001 Fever 11 days, post vax. U 05/07/2001 05/08/2001 1 NONE PVT PUB NONE NONE 1
0170280 05/24/2001 PA 82.0 82 F 05/21/2001 One week, post vax, site erythemic induration and area measured in size to about 8cm in diameter, was very itchy and warm to touch. Rx'd Biaxin 500 mg BID x 7 days, Benadryl cream, Zyrtec 10mg and ice pack. Vital signs on 5/15/01, BP 172/100; HR-64; Afebrile; RR-16. Y 05/08/2001 05/15/2001 7 NONE PVT PVT Toprol XL, Zyrtec; Centrum Silver; Pravachol; Fosamax NONE Allergy to adhesive tape, prednisone 1
0170281 05/24/2001 CA 1.25 1 .4 M 05/15/2001 At 14:48, left deltoid area reddened and swollen to approx. 10cm X 10cm and warm. Temperature 36C. Y Y 05/10/2001 05/11/2001 1 UNK UNK NONE 1
0170282 05/24/2001 CO 5.0 5 F 05/09/2001 Erythematous, macular rash, itchy and warm. Tx: Augmentin and Benadryl. Y U 05/07/2001 05/08/2001 1 NONE PVT PVT 1
0170283 05/24/2001 TX 1.25 1 .3 M 05/11/2001 Swelling from of right leg from hip to knee; botchy red area on upper thigh, not directly around injection site. Y 05/10/2001 05/11/2001 1 PVT PVT Tussi 12 NONE NONE 1
0170284 05/24/2001 NE 1.3 1 .4 F 05/10/2001 Fever up to 104.3" on days 7 & 8, post vax. Y Y 04/30/2001 05/06/2001 6 5/7/01 had CBC with WBC-13,000 with 64 segs, 6 bands, 20 lymphs, 8 monos, 2 eos; Strep screen-neg PVT PVT NONE NONE NONE 1
0170287 05/25/2001 IL 1.94 1 .9 F 05/01/2001 Child became pale and limp at 14:59. Had cyanosis of lips with wheezing at 15:00. Epinephrine .3cc, SC, LL and Benadryl 12.5mg, IM, RL given at 15:00. 911 called with laying down child on floor and checking respirations. At 15:00, R-24; P-110 and BP 70/30. Lethargic response to verbal stimuli, expiratory wheezing heard bilaterally per stethoscope; paramedic here and assisted to lay seat. Pulse Ox-98% on room air. Sent to hospital via ambulance. Was transferred to another hospital for 23 hours of observation to her pulmonary management. Discharged on 5/2/01 from hospital. Y Y 1 Y 05/01/2001 05/01/2001 0 PUB PUB Zyrtec, albuterol Asthma and eczema Allergies to dogs, egg whites and peanuts. IL01014 1
0170288 05/25/2001 MI 1.0 0 1 M 04/26/2001 Mother states the child had diarrhea prior to vaccine. Vaccine was given on 4/20/01 at 15:00. The child was fine initially following vax. At 03:00 AM woke with hives and at 4:00 am the child was brought to the ER where the MD related the symptoms to Prevnar vax. Y Y 04/20/2001 04/21/2001 1 PVT UNK diarrhea NONE 1
0170289 05/25/2001 CA 3.0 3 F 05/16/2001 The pt experienced extreme swelling around the site of vax on right leg. Y 05/15/2001 05/16/2001 1 UNK UNK 1
0170290 05/25/2001 WA 4.0 4 F 05/09/2001 The pt began with dime sized red rash on both legs on 5/5/01. By 5/6/01 the pt had a rash covering both thighs with a little on her face. The pt was very cranky and tired. The doctor suggested Benadryl. The pt was given Benadryl and symptoms faded gradually. Y 05/04/2001 05/05/2001 1 PVT PUB rash~DTaP (no brand name)~4~3.00~In Patient OR200121 1
0170291 05/25/2001 CO 1.0 1 .0 M The pt experienced red, tender palpable induration at the injection site. Y 05/16/2001 05/18/2001 2 PVT PVT 1
0170292 05/25/2001 GA 1.4 1 .5 M 05/24/2001 The pt experienced swelling to the right thigh following vax. The area was warm to the touch, with erythema. The child walks stiffly on right leg. The reaction occurred 24 hours post vax. Y U 05/22/2001 05/23/2001 1 NONE MIL MIL Tylenol NONE eczema, esotropia 1
0170293 05/25/2001 IL 0.25 0 .3 M 05/02/2001 The mother called and stated the are on right lower thigh was red, and sore on 5/2/01. Feels warm to the touch, states child not eating as well and was somewhat fussy. The pt has several bumps at the injection site. Y 04/30/2001 05/02/2001 2 NONE PUB PUB NONE IL01016 1
0170294 05/25/2001 ND 24.0 24 M 05/17/2001 The pt experienced flu like symptoms, sore muscles and mild fever, mild swelling, soreness in glands under jaw. Swelling and soreness in the arm. Y 05/14/2001 05/15/2001 1 MIL UNK PPD / Connaught NONE NONE 1
0170295 05/25/2001 TX 14.0 14 M 05/24/2001 The pt experienced a rash 1-2 hours post vax. Small dots, very itchy. Rash still present on 5/14/01. Y 05/04/2001 05/09/2001 5 PVT UNK NONE NONE NONE 1
0170296 05/25/2001 CA 64.0 63 F 05/16/2001 The pt experienced redness, swelling in the left deltoid 1.5 days post vax. 8 days later the pt experienced a "huge welt" 5 1/2"x6 1/2" in diameter accompanied with 99.6 temp and itching. The pt went to the ER and received IV antibiotics and oral Cipro. Y Y 05/02/2001 05/04/2001 2 OTH PVT NONE NONE 1
0170297 05/25/2001 MA 4.0 4 M 05/21/2001 Rash, hives, mild respiratory, red and raised area at MMR site. Y Y 05/18/2001 05/18/2001 0 PVT OTH CP, Quadriplegia 1
0170298 05/25/2001 MA 7.0 2 .0 M 05/18/2001 Developed 1 spot on leg on 5/15/01, spread overnight. Seen today, 5/17/01, in office with multiple vesicles on back, stomach and legs. Y Y 05/23/1996 05/15/2001 1818 PVT PVT NONE 1
0170299 05/25/2001 IL 3.0 3 F 05/19/2001 Redness of right arm noted during 1st 24 hours, post vax. Y 05/17/2001 PVT PUB NONE 1
0170300 05/25/2001 PA 70.0 70 F 05/21/2001 Dizziness, injection site itchy and loss of appetite. Treated with Keflex 500mg and Prednisone 10mg. Y Y 05/03/2001 05/18/2001 15 NONE PVT PVT NONE HTN, NIDDM, COPD, Asthma 1
0170301 05/25/2001 MN 39.0 39 F 05/11/2001 Pt received Pneumococcal 23 in AM of 5/7/01 and that evening, she developed shaking-chills, body aches, headache and discomfort at injection site. On 5/8/01, she was seen and evaluated by NP who ordered CXR for her cough and this was negative. She was started on Biaxin XL 500mg, 2 tabs together for 7 days. She was cautioned to return to office if symptoms exacerbate and redness increases over 1 cm, over the next 48 hours. She returned to office on 5/9/01 and was seen by physician who ordered labs, started her on Dicloxacillin and ordered injection of Rocephin. She was to monitor symptoms and report to ER if the symptoms got worse or higher temperatures. We telephoned her each day, to monitor her progress. Addendum: On 5/14/01, she returns to office with her daughter and her arm looks much better, only small area of hardness at injection site. Y U 05/07/2001 05/07/2001 0 WBC; Sed rate; C-reactive protein; CXR PVT PVT Ventolin, Aeroloid, Serevent, Colace, Allegra, Beconase, Minocin Mild URI symptoms, cough, congestion, stomachache Asthma 1
0170302 05/25/2001 IL 1.0 1 .1 M 05/09/2001 Mother called on 5/4/01 concerned due to large "knots" at the injection site. The largest is the size of an egg. Was told to call MD. On 5/9/01, spoke with the father and father states the swelling has gone down. Y Y 04/30/2001 05/04/2001 4 PUB PUB NONE IL01015 1
0170303 05/29/2001 PA 0.08 0 .1 F 05/11/2001 This patient was seen on 05/04/2001 for a well physical exam. The patient was given Hep B vaccine # 1 on 05/04/01. The Health Bureau was notified on 05/07/01 at 8 AM that the involved child had expired over the weekend. Autopsy states cause of death as sudden death in infancy. Autopsy also showed E. Coli septicemia. Y 05/05/2001 N 05/04/2001 PUB PUB On 4/19/01 had Medimmune/Synagis/QA7181A/IM/LL/0 previously NONE Prematurity - gestational age at 36 weeks. 1
0170304 05/29/2001 76.0 M 05/23/2001 Information has been received from an investigator regarding a 76 year old male who received a dose of Influenza virus vaccine trivalent, types A & B, live cold-adapted (frozen formulation) on 11/10/98 as a part of the study, a Randomized, Controlled, Blinded, Multi-Center Trial to Assess the Efficacy of Protection From Natural Influenza Virus Infection of Influenza Virus Vaccine Trivalent, Types A & B, Live Cold-Adapted (CAIV-T) and Inactivated Influenza Virus Vaccine in Patients With Chronic Obstructive Pulmonary Disease (COPD): A Field Trial". On 11/16/98, the patient developed an exacerbation of chronic obstructive pulmonary disease. He recovered by 12/01/98. The investigator considered the exacerbation of chronic obstructive pulmonary disease (unexpected per the investigator brochure) to be medically important and "possibly" related to study vaccine administration. The medical monitor's assessment was unknown. Y 11/10/1998 11/16/1998 6 NONE UNK UNK UNK COPD HQ1160222MAY2001 1
0170312 05/29/2001 GA 3.0 M 01/17/2002 Information has been received from a consumer concerning her son with no known allergies and no past medical history who was vaccinated with MMRII (lot 0109E). It was reported that the child also got "more than one hepatitis b vaccine shot". His mother did not know the specific dates of the vaccinations, but she did report lot numbers. The 1st lot number she reported was for hepatitis b vaccine recombinant (yeast) (MSD) (lot #615998/0642D) and the 2nd lot number she reported was for hepatitis b vaccine recombinant (yeast) (lot #2149A2-invalid lot). No other concomitant medications were noted. It was noted that in July or August 2000, the pt was dx'd with autism. Upon internal review, autism was considered an "Other Medical Event". Additional information has been requested. Follow-up info has been received from a physician's office. The child was seen on 02/10/2000 for evaluation of speech therapy. He weighed 36 pounds, had a temperature of 9702 and was on no medications. He did not talk much. He had been in therapy for 5 months and it was noted that the pt spoke 15-20 isngle words with no sentance and no disarticulations. He remained about 1 1/2 months behind, but he did say some words he didn't use to say. He had no repitive words and no echolalia, though he was able to communciate his needs. It was noted,"borderline (mild) MR." The child was being referred for a second opinion because of parents were not satisfied with his current therapy. The institution suggested mild autism and the family did not agree. On 04/30/2000 he was seen for his 3 year visit. All physical findings were normal. He weighed 37 pounds, was 38.5 tall, BP 90/48 and had a temp of 96.1. The only concern was his speech therapy. It was noted that he had no autistic features, was going to speech therapy and was to start occupational therapy. Plan was for a lead test, and an evaluation of his speech by another physician. It was noted that on 05/04/2002 the pt may have been diagnosed with autism. In September 2000 the pt was seen for ear pain that started the morning of his visit. It was noted that he wasn't sleeping well and woke up screaming and pulling his ears. He weighed 39.5 pounds, had a temp of 98.0 and was taking ibuprofen. It was noted that he had possible "BOM" but his typanic membranes could not be seen due to a large amount of ear wax. It was also noted that it was a difficult exam due to mild autism. He was prescribed ampicillin for 10 days, mineral oil 3 drops each ear for 10 days and continue ibuprofen for pain. On 10/10/2000 the pt was seen to re-check his ears. He weighed 38.5 pounds and had a temperature of 97.2. He had finished the amoxicillin and was using the mineral oil every day. The child contined to pick at his ear, was congested and had a runny nose. On exam he had cerumen impacted that was removable with a curette. An appointment was made with another physician for evaluation of his ears. On 11/01/2000 the pt was seen with complaints of vomiting twice that started that day. He weighed 37 pounds, had a temp of 96.5 and was on no medication. It was noted that he had no diarrhea, had a decreased appetitie and was taking some fluids. The impression was acute gastroenteritis. The plan was to do a rapid stress test and a throat culture if negative. He was to avoid mild and juice and take Dimetapp. He was scheduled for cerumen removal under sedation the following week. On 12/21/2000 the pt wsa seen for complaints of diarrhea that had been going on for 2 weeks. He weighed 39 pounds had a temp of 96.1 and was on no medication. It was noted that there was no vomiting and no blood in the stool. He was afebrile and had a rash on his bottom. Plan was to get a stoolC4S, a stoll C47, increase fiber and cut out milk and juice. On 12/22/2000 the pt's mother called and were told that both stool cultures had negative results. On 01/04/2001 the pt was seen for complaints of a runny nose, vomiting and pulling both ears. His ears had been bothering him for a week and the vomiting started that morning. It was also noted that he had diarrhea for 3 days, but his stool was normal that day. It was noted that he had a URI and gastroenteritis without dehydration. He was given cabinoxamine maleate hydrocodone bitartrate pseudosphedrine hydrochloride 6 hrs prn for runny nose. On 01/17/2001 the pt wsa seen for follow-up after hospitalization on 01/13/2001 for dehydration. He was discharged on 01/16/2001. He weighed 41.5 pounds, had a temp of 96.5 and was on no medication. He had no vomitin, but stil had loose stools. No blood was noted. He was afebrile and was sleeping good and eating good. On 01/23/2001 the pt was seen for pre-up to dental surgery for caries. He weighed 38 pounds, had a temp of 97 and was on no medication. He had no vomiting or diarrhea at the time and he was given the OK for his surgery that was to be done on 01/16/2001. It was noted that the time that the pt had a history of Pervasive Developmental disorder. On 02/21/2001 the pt was seen for complaints of a fever, headache and stomach pain that started the previous night. He weighed 40 pounds, had a temp of 97.5 and was taking Tylenol and Motrin. It was noted that the pt vomited once on 02/26/2001 and complaiend that his stomach hurt. HIs t-max was 100.5, his nose was stuffy, his throat was red and the impression was pharyngitis. It was nted AS+ and IPRS +. He was given amoxicillin for 10 days and another dental surgery was rescheduled. On 03/06/2001 the pt was seen for a clear for dental surgery. The pt weighed 41 punds had a temp of 98 and was on no medication. It was noted that ENT had diagnosed him with strep on 02/31/2001. He was given an OK for dental surgery. On 05/07/2001 the pt was seen with complaints of stomach pain that had been ongoing for 6 months. He weighed 41.5 pounds, had a temp of 94.7 and was on no medication at that time. It was noted that his bowel movements went from soft to diarrhea to constipation. Sometimes they were hard and sometimes they were watery. There was no blood noted. It was also reported that he gags when eating and is restless at night. The school nurse noted an increase in urine output. A UA was to be doen. The impression was constipation and bowel impaction. On 05/10/2001 it was reported that he used the suppositary and senna as ordered for two days and that morning had a moderate amount of watery stool with mucous. The Senna was discontinued and the child was to restart the rest of the protocol as ordered. On 05/14/2001 the pt's mother called requesting a peptide level for "autism change." Referral was given. On 06/28/2001 the pt was seen to check his ears and his urine. He weighed 40 pounds, had a temp of 98.4 and was on no medication. He was acting like his ears hurt and like it hurt to void. A small amount of stool was palpated on exam and his throat showed erythema. Impression was pharyngitis and constipation. A UA was done and he was given hisacodyl for 3 days, NOM , PO Bid for 2 weeks and suggestion of no bubble baths and increase in fiber. It was noted htat Tylenol and Motrin could be given prn. It was also noted that a rapid strep test would be done and throat culture if negative. On 09/12/2001 the pt was seen for a cold in the eyes that had been going on 2 weeks. The pt weighed 42 pounds, had a temp of 97.1 and was taking Dimetapp. It was noted tha this eyes were matted together, he had a runny nose (green), a hacky cough and congestion. There was no sore throat and no vomiting. His teacher reported one loose stool the day prior. On exam he had purulent discharge fro a stuffy nose, yellow discharge from the corners of his eyes. The impression was conjunctivitis and a URI. He was given gentamicin ointment ot be applied TID, amoxicillin for 10 days and "Palgic DS" prn. On 10/16/2001 the pt's mother called to report he was bitten by "fire ants." She was instructed to give Benadryl. He was then seen in the office. He weighed 44 pounds had a temp of 96.5 and was using diphenhydramine hydrochloride cream. It was noted that the pt had bites on his legs, back and scrotum. The "bite" on his scrotum ws athe worse and it had swelling and had "turned black." He was scheduled for color doppler ultrasound of the tests and surgery was consulted to rule out testicular corsion. He had decreased activity, was irritable and had decreased voiding, but would walk. On 10/21/2001 it was reported that the testicles were just bruised from swelling at the bug bites, but that it looked better. Upon internal review autism was considered an other important medical event. Additional info has been requested. Y Y 4 N 07/01/2000 OTH OTH NONE WAES01051444 1
0170313 05/29/2001 NY 1.0 1 .1 M 06/21/2001 Information has been received from a pediatrician concerning a 12 month old male who on 4/20/01 was vaccinated with varicella virus vaccine live. On 4/22/01, the pt developed a fever (105.8F) and experienced a complex febrile seizure which lasted for approximately 35 minutes. The patient was taken to the ER and administered oxygen, lorazepam, intravenous phenobarbital, and intravenous Rocephin. The patient was transported to another hospital's pediatric care unit for 4 days. The patient was discharged with rectal valium, if needed. The pediatrician at a follow-up visit described the patient as "recovered and looks great", and told the mother that her child may have had a viral infection. It was also noted that the patient, and sibling, did not have any adverse events following prior vaccinations. Additional information is not expected. Y Y 4 Y Y 04/20/2001 04/22/2001 2 chest x-ray, computed axial, diagnostic laboratory, spinal tap, neurological examination PVT PVT cephlosporin allergy WAES01050821 1
0170314 05/29/2001 IN 14.0 14 M 06/05/2001 Information has been received from a physician concerning an immunocompromised patient with cerebral palsy who on 04/11/01, was vaccinated with Varicella virus vaccine live. On 04/15/01, the patient developed a severe case of chicken pox. On the same date, the patient was hospitalized for a skin infection which was considered possibly due to the chicken pox. The physician reported that the patient had no prior exposure to wild type varicella and that he did not know the nature of the skin infection. In follow-up, the physician reported that he did not have much additional information to report but was in the process of trying to gather additional information. In addition, the physician stated that he believed that the patient had not had a recent varicella exposure, was not immunocompromised and had recovered but will attempt to confirm this information. Additional information has been requested. Follow up information has been received from a physician who reports the patient was diagnosed with cellulitis and secondary infected chicken pox and had subsequently recovered as of 04/30/2001. It was reported that the child had a persistent fever with his chicken pox. When admitted to the hospital he was treated with Kefzol. At the time of discharge the pt did have some active pox, but he was afebrile and his appetite had returned. He was given Duricef at discharge to continue for 1 week. No further information is expected. Y Y Y 04/11/2001 04/15/2001 4 UNK PVT OTH UNK Cerebral Palsy; immunosuppression WAES01051150 1
0170315 05/29/2001 CT 0.2 0 .2 F 05/22/2001 Vaccines given at 10:00 AM at 2 month well visit without problems. On 5/18/01, at 16:00 in the afternoon, pt sleeping in non-moving swing and awoke screaming and went limp, per mom. Pt seen at ER. Alert, breathing normal with ? low O2 sats. Transferred to another hospital where O2 sats were 95% and pt appeared fine. Unknown if vaccine related. Diagnosed with cyanosis Y Y 1 Y 05/18/2001 05/18/2001 0 PVT PVT NONE NONE NONE 1
0170316 05/29/2001 PA 81.0 79 M 05/20/2001 Extreme pain in neck, shoulders, arms, joints and legs. Feeling of malaise lasting for several weeks after each vaccination and recurring off and on without warning, often now. First original Lyme dx discovered by a spinal tap in a hospital. Had 2 additional Lyme vaccinations on 4/15/00 and 4/15/01. Slight fever. Malaise and joint discomfort "comes and goes" Pt unsure if this is permanent. Fever has abated. Left carpal tunnel was diagnosed 02/2001 and surgically corrected. Y N 03/15/2000 03/18/2000 3 First original Lyme dx discovered by a spinal tap in a hospital PVT PVT Hytrin NONE BPH 1
0170317 05/29/2001 FL 0.3 0 .4 F 05/01/2001 Spoke with MOC on 4/25/01, she stated child had no reaction with 1st DTAP. However, with his 2nd DTAP, he had an elevated temperature of 105F, inconsolable crying 6 hours and was very rigid "stiff as a board". Twin sister had no reaction to DTP on 2nd dose. Y Y 04/19/2001 04/19/2001 0 NONE PUB PUB Bilateral inguinal hernia repair 4/2/01. Fever~DTaP (no brand name)~1~0.00~In Patient|~DTP (no brand name)~2~0.30~In Sibling|~DTP (no brand name)~2~0.30~In Sibling FL01012 1
0170318 05/29/2001 FL 0.3 0 .4 M 05/01/2001 The pt experienced hives which were present on upper thighs, abdomen, arms and face. Accompanied by a fever of 102 rectally. Brought in on 5/1/01 to health department. Vaccines given on 4/30. Referred to PMD. Y U 04/30/2001 04/30/2001 0 PUB PUB NONE NONE NONE FL01010 1
0170319 05/29/2001 FL 0.6 0 .4 F 05/01/2001 Spoke with Mom of child, child had seizures with unconsolable crying and elevated temp for 3 days following administration of second DTAP. Y Y 01/30/2001 01/30/2001 0 UNK UNK NONE NONE asthma FL01011 1
0170320 05/29/2001 NH 0.5 0 .5 F 05/21/2001 The pt experienced induration for 2 days. U 05/18/2001 05/19/2001 1 NONE PVT PUB NONE NONE NONE NH0115 1
0170321 05/29/2001 WV 5.0 5 M 05/17/2001 The pt experienced edema with erythema, tenderness, hardness and warmth to the touch. Y Y 05/14/2001 05/15/2001 1 PVT PVT 1
0170322 05/29/2001 OH 2.0 2 .9 M 05/07/2001 Developed nodule at the site of injection, then developed centrifugal erythema around the site 5 days later. Y 05/02/2001 05/07/2001 5 NONE OTH PUB Ferisol NONE NONE 1
0170323 05/29/2001 MA 1.5 1 .6 M 05/22/2001 5 days post vax, the pt developed erythema multiform. No other symptoms. N 05/15/2001 05/21/2001 6 PVT PUB NONE NONE 1
0170324 05/29/2001 TX 2.0 2 .1 M 05/15/2001 Fever on 5/10/01 and 5/11/01. Temperature max 104.3F. Swelling and induration, redness, tenderness at injection site about 6cm with lump and pruritus. Treated with Benadryl IV, Augmentin, Tylenol and Motrin and ice packs/hot packs. Y Y 05/09/2001 05/10/2001 1 NONE PVT PUB Zyrtec, Serevent, Xopenex, Flovent Asthma and allergic rhinitis 1
0170325 05/29/2001 AZ 0.7 0 .7 F 05/15/2001 31 hours, post vax of Prevnar, awoke from nap with a temperature of 101.5F and shaking movements of whole body. Fever increased and then decreased X 72 hours (up to 102F) and hypotonia X 48 hours with lethargy. Poor fluid intake. Treatment with alternating Tylenol and Motrin every 3 hours and push fluids. Rechecked 24 hours later and fever persists but recovering; normal tone. Y Y 04/04/2001 04/05/2001 1 Urine CX-neg PVT PVT NONE NONE 1
0170326 05/29/2001 MD 1.5 1 .6 M 05/21/2001 Per mother on 5/18/01, child was given Motrin between 16:00 and 17:00. Child appeared "sluggish" in PM. Child had seizure at approx. 19:15 on 5/16/01. Child taken by EMS to a medical facility. Mother was told WBC's were elevated. Child was given antibiotics. On 5/18/01, child was still receiving antibiotics and Motrin. No further problems. Seizure precautions discussed with mother. Y Y 05/16/2001 05/16/2001 0 WBC-elevated PUB PUB Child given acetaminophen 1 1/2 drops at 11:21 AM prior to vaccines being given. NONE History of seizures, last one 2 months ago. 1
0170327 05/29/2001 NY 0.3 0 .4 F 05/21/2001 Temperature up to 104F X 3 days. Y Y 03/18/2001 05/18/2001 61 NONE PUB UNK NONE 1
0170328 05/29/2001 CA 1.3 1 .3 F 05/21/2001 Pt woke from a nap on 5/17/01 with 10-15 water blisters on abdomen, gradually increased spots until 5/19/01 with a total of 50-60 spots. Now all gone. Afebrile. Y Y 05/09/2001 05/17/2001 8 NONE PVT PVT NONE NONE NONE 1
0170329 05/29/2001 FL 3.0 3 M 05/18/2001 Bilateral orbital swelling. Treated with Claritin Reditabs and Prelone 20mg po. Y 05/18/2001 05/18/2001 0 NONE PVT PUB NONE NONE NONE 1
0170330 05/29/2001 WI 0.2 0 .0 F 05/24/2001 Pt developed fever and 1 minute seizure with stiffening, eyes rolling and then limp and unresponsive about 9-10 minutes, post vax. Phoned on 6/4/01/and 6/8/01 and pt still not so responsive as before vaccine. Y Y 05/18/2001 05/18/2001 0 EEG; MRI PVT PVT NONE NONE NONE 1
0170331 05/29/2001 NY 0.9 0 .9 F 05/24/2001 High fever 102.1F to 103.3F, vomiting, coughing, nasal congestion, irritability and shaking. Y Y 05/23/2001 05/23/2001 0 PVT PVT NONE NONE 1
0170333 05/29/2001 CA 20.0 20 M 05/10/2001 Pt received typhoid, flu and Hep-A vaccines and approx. 30 seconds, post vax, pt had a syncopal episode with duration of 45 seconds to 1-2 minutes. Y U 05/10/2001 05/10/2001 0 NONE MIL MIL UNK UNK NONE 1
0170334 05/29/2001 MA 43.0 43 M 05/18/2001 Hives developed on 5/15/01, rapidly spread over head, trunk and limbs. Had chills X 2 hours on 5/15/01. No other symptoms and no dyspnea. He had little clinical response to Benadryl (50mg every 4 hours X 1 day), but improved rapidly with added Rx of prednisone (20mg tid). Y Y 05/10/2001 05/15/2001 5 PVT PVT Allegra; Flonase Hay fever Hay fever, allergy to sulfa, Cipro, erythromycin, amoxicillin 1
0170335 05/29/2001 NY 6.0 6 M 05/16/2001 Left upper arm 5cm X 5cm round, erythematous lesion, warm to touch with pain and itching. Advised pt to give Advil for pain and use warm compresses. Y 05/14/2001 05/15/2001 1 NONE PVT UNK NONE NONE NONE 1
0170336 05/29/2001 GA 9.0 7 M 05/17/2001 Had outbreak of varicella. Y 05/18/1999 NONE PVT UNK NONE NONE 1
0170337 05/29/2001 PA 4.0 4 M 05/19/2001 Left arm, red, swollen, hot and itchy. Y U 05/17/2001 05/18/2001 1 NONE PUB PUB NONE NONE RAD 1
0170338 05/29/2001 NY 16.0 16 F 05/16/2001 Erythema, swelling and tenderness right shoulder, upper 1/3, decreased ROM. Y 05/12/2001 05/13/2001 1 UNK UNK 1
0170339 05/29/2001 AZ 0.5 0 .5 M 05/17/2001 Approx. 6 hours, post vax, infant developed fever to 104F and inconsolable crying. Was seen in ER and given Motrin. The fever and crying lasted about 24 hours. Followed up this AM 5/17/01. Physical exam revealed no infection source. Y Y 05/15/2001 05/15/2001 0 NONE PVT PUB Upper resp infection, fever of 99.6F NONE 1
0170340 05/29/2001 CA 4.0 4 M 05/21/2001 5 days, post vax, on 5/14/00, pt developed fever of 103F X 2 days, vomited X 1, pale. Fever resolved and macular-papular rash appeared on 5/19/01. Probable viral illness. Mother wished to report. Y 05/09/2001 05/14/2001 5 PVT PVT NONE Allergy to ibuprofen 1
0170341 05/29/2001 KY 4.0 1 .0 M 05/21/2001 Rash (about 20 small papular lesions) trunk only. Y 05/20/1998 05/21/2001 1097 PVT PVT 1
0170342 05/29/2001 VA 22.0 22 F 05/11/2001 Myalgia and arthralgia which started within 24 hours. Treated with Prednisone and ibuprofen. Y 04/30/2001 05/01/2001 1 OTH PUB OC's NONE Allergic to Iodine and Robitussin; Acne 1
0170343 05/29/2001 MI 13.0 13 M 05/16/2001 Weakness, decreased level of consciousness. At 11:15 AM, did not feel like going on the bus, said he felt tired. Gave him juice, water, crackers and was able to keep down. No nausea or vomiting. Pulse normal; ambulating well. At 12:00 noon, weaker. Went on bus to hospital. Pulse still normal range. Pt observed for 2 hours and 35 minutes in ER. Y Y 04/16/2001 04/16/2001 0 NONE PUB PUB NONE NONE NONE 1
0170344 05/29/2001 NJ 4.0 4 F 05/18/2001 Erythema and warmth emanating from vaccine site within 1st 24 hours, spreading to 14cm by 48 hours. Y U 05/15/2001 05/16/2001 1 PVT PVT 1
0170345 05/29/2001 VA 30.0 30 F 05/23/2001 On 5/10/01, AM vaccinated. In the PM, had swelling deltoid, achy, sleepiness. On 5/11/01, AM, swelling shoulder to elbow, red deltoid, arm "achy" PM. Area on right at 1st injection reddened and swollen, deltoid region. On 5/12/01, arm swollen decreased into hand. Warm compresses applied and took Benadryl and Advil. On 5/13/01, both arms, "itching", lasting until Thursday. Raised areas on both arms at injection site until then, too. Y 05/10/2001 05/10/2001 0 PUB PVT NONE NONE 1
0170346 05/29/2001 NJ 10.0 10 F 05/17/2001 On 3/9/01, had low-grade fever and flushed cheeks. On 3/11/01, developed a fever of 102.4F. On 3/12/01, had PMD appt. and received RX for antibiotic; Zithromax. On 3/13/01, had not started RX yet. A rash developed all over child's body that burned and then itched. Took Benadryl. On 3/14/01, rash gone on antibiotic. On 3/15/01, child was tired and had a headache. On 3/16/01, returned to school. PMD dx'd it as a virus. Other children she was in contact with in the Synagogue were also sick with burning hands and feet, upper respiratory infections and headaches. After medical clearance, the 2nd dose of Hep-B was given on April 5, 2001 without any reaction. Y Y 03/08/2001 03/09/2001 1 OTH PVT NONE NONE NONE NJ200112 1
0170347 05/29/2001 TX 12.0 12 F 05/17/2001 Injection given in left deltoid and had rash around injection site and warm to touch. Site cleaned with alcohol swab 2 1/2 X 2 width with scattered rash on upper shoulder to collar bone. Temperature 96.9F before injection and 98F, post vax. Complained of headache and dizziness. Y 05/17/2001 05/17/2001 0 NONE OTH OTH NONE NONE Allergy to Amoxicillin 1
0170348 05/29/2001 WV 4.0 4 F 05/18/2001 3 days, post vax, pt had knot on left leg and developed a circumferential redness, measuring 2 1/2" X 2 1/4". Treat with Motrin and Benadryl or Zyrtec. Y 05/15/2001 05/17/2001 2 PVT PVT Zyrtec 10mg qd prn NONE NONE 1
0170349 05/29/2001 FL 0.6 0 .6 M 05/01/2001 Mother of child stated that she noticed that the child was "not acting himself". He had elevated temperature and inconsolable crying X 8-12 hours, due to shots given on 12/29/1998. U 12/29/1998 12/30/1998 1 PUB PUB FL01013 1
0170350 05/29/2001 FL 11.0 11 F 04/09/2001 Rash on face which got worse. Face was puffy, had difficulty breathing and throat "felt funny". Dizziness also, then rash spread to neck and arms. Still has rash today on 4/9/01. No fever, no other symptoms. Had rash after first HBV but less severe. Rash on 4/5/01 at 07:00; SOB on 4/7/01 at 02:00 and saw MD at ER and gave Benadryl. Y Y 04/04/2001 04/05/2001 1 NONE OTH PUB NONE NONE NONE Rash for 4 or 5 days~Hep B (no brand name)~1~11.00~In Patient|~Vaccine not specified (no brand name)~4~1.00~In Sibling FL01009 1
0170351 05/29/2001 FL 12.0 12 M 05/15/2001 Child presented to clinic on 5/15/2001 at 08:30 AM, with multiple erythematous, papular, pruritic lesions on body; which developed approx. 36 + hours, post vax, Hep-B (primary dose). Child seen by PMD and given RX for Atarax. U 05/09/2001 05/11/2001 2 PUB PUB NONE NONE FL01015 1
0170352 05/29/2001 FL 11.0 11 M 04/11/2001 On the same day of vax the pt woke at 11:00 pm complaining of itching, and breaking out with hives. He also complained of a sore throat. On the next day, the pt complained of swollen throat and lips which bilaterally resolved prior to evaluation. Y U 04/10/2001 04/10/2001 0 PUB PUB NONE FL01014 1
0170353 05/29/2001 OH 5.0 5 F The pt woke with red area on left upper thigh and was hot to the touch, 3cm erythema and induration. Y 05/22/2001 05/24/2001 2 PVT OTH 1
0170354 05/29/2001 MI 3.0 3 M 05/24/2001 One day post vax, the pt experienced redness and swelling of the injection site. In addition the pt developed urticaria lesions to the groin area. Urticaria on abdomen and spread up to the chest, back and arms. Y 05/21/2001 05/22/2001 1 PVT PVT Xopenex, Extendryl, Intal, Alupent NONE delayed speech and gait abnormality 1
0170355 05/29/2001 PA 6.0 1 .3 F 05/24/2001 Varicella vaccine administered on 3/11/96 broke out with varicella on 3/28/01 with greater than 50 lesions. Y Y 03/11/1996 03/28/2001 1843 NONE PVT OTH NONE NONE NONE 1
0170356 05/30/2001 CA 53.0 53 M 05/23/2001 It was reported that an adult male pt received a Menomune A/C/Y/W-135 vaccination on 3/6/00. Reportedly, the pt died on 4/14/00. dx'd with purulent meningitis. Autopsy done at medical examiner's office. Further medical follow-up is requested and ongoing. On 05/22/2001, the autopsy and medical examiners reports were received. Autopsy report revealed the following findings from the head and central nervous system. "The leptomeninges overlying the frontal lobes have yellow-green opacified material present, consistent with purulent meningitis process." From the correspondence received from a physician it was stated "This case was associated with large numbers of gram positive diplococci having the morphology consistent with S. pneumonia. A silver stain and a PAS did not support the presence of any other organism." Y 04/14/2000 N 03/06/2000 04/14/2000 39 Autopsy-lobes have yellow green opacified material present, consistent with purulent meningitis process. UNK UNK None Chronic back pain, atherosclerosis Hx of nasal allergy, periodic HTN, rectal polyps, Hepatitis B, and ETOH abuse U2001007430 1
0170360 05/30/2001 NY 38.0 37 F 05/18/2001 Information has been received from a 38 year old white female with no known allergies and a history of a right ovarian cystectomy for a dermoid and a c-section who on 7/5/00 was vaccinated with 1 dose of varicella virus vaccine live. There were no concomitant medications. There was no local reaction at the vaccination site and no post vax varicella or herpes zoster noted. Subsequently, the pt found out that she was pregnant. The reporter indicated that she was about 3 weeks pregnant. Additional information received on 8/7/00 from an RN indicated that the pt's date of LMP was on 7/2/00. EDD: 4/8/01. Additional information received on 8/17/00 from an RN, indicated that the pt conceived 3 weeks after vaccination. Follow-up information from a health professional reports, the pt phoned the office on 3/19/01 with complaints of decreased fetal movements. She scheduled a non stress test for the following day. The results were not reported. Multiple lab tests were done which were within normal limits. The baby was in breech presentation. She delivered a baby boy by c-section on 3/28/01. He weighed 7 lbs 11 oz. and hypospadias was noted. The doctor did not know the extent of the hypospadias. On 4/3/01, the pt phoned complaining of pain in both hips. She was instructed to call if the symptoms persisted for more than 1 week. No further information was provided. Additional information is expected. U 07/05/2000 03/28/2001 266 Lab 8/29/00-varicella non-immune; beta-human chorionic 8/7/00-25274.64; beta-human 8/29/00-174009.85 OTH OTH NONE Cesarean section; ovarian cyst removal WAES00080582 1
0170363 05/30/2001 LA 40.0 40 F 05/25/2001 The pt was disoriented, experiences loss of short and long term memory, dizziness, aches, pain, increased depression, increased Fibromyalgia symptoms. Y Y N 02/02/2000 02/02/2000 0 PVT PVT UNK NONE Fibromyalgia, depression, chronic fatigue 1
0170364 05/30/2001 IN 1.25 1 .3 F 05/25/2001 The father states the pt was given Tylenol as soon as they returned home from the clinic. The pt acted fine. Within 6 hours her temp "shot" up and she had a seizure. Was taken to the ER and admitted to the hospital for observation. She was on an IV and was in the hospital 1 day. She is home now and is acting like she feels ok now. MD thinks it is due to DTAP. Y Y 1 Y 05/23/2001 05/23/2001 0 CSF culture did not grow anything PUB PUB NONE NONE NONE 1
0170366 05/30/2001 UT 0.5 0 .6 F 05/29/2001 Small pin-point rash on thighs near injection sites, 2 days, post vax. Y U 05/22/2001 05/24/2001 2 PVT PVT Amoxicillin Ear infection 1
0170367 05/30/2001 AL 4.0 4 F 05/17/2001 2 hours, post vax, parent brought child into health dept. Child had whelps on chest and throat hurt, child states, no respiratory distress. Sent child to PMD for evaluation and treatment. Health dept called office for follow-up visit. PMD used epinephrine and steroids for 24 hours and child's whelps disappeared. Y Y 05/17/2001 05/17/2001 0 PUB PUB NONE NONE NONE AL0107 1
0170368 05/30/2001 CA 0.2 0 .2 F 05/17/2001 Inconsolable crying for 3 1/2 hours, non-stop. Y Y 05/07/2001 05/07/2001 0 PVT PUB 1
0170369 05/30/2001 MI 3.0 3 F 05/11/2001 Pt has a rash. Y 05/08/2001 05/10/2001 2 PVT UNK 1
0170370 05/30/2001 NJ 40.0 40 F 05/17/2001 Bruise and pain at administration site. Nausea X 3 hours. Bruise and soreness X 4 days. Y 04/24/2001 04/24/2001 0 NONE PUB PUB Vitamins NONE NONE 1
0170371 05/30/2001 NJ 51.0 51 F 05/17/2001 Site reddened and hot. Pain at site only. No treatment. 6 days duration. Y 05/01/2001 05/02/2001 1 NONE PUB PUB Premarin; vitamins NONE NONE 1
0170372 05/30/2001 NJ 24.0 22 M 05/17/2001 Round, red area X 8mm around injection site, lasting 4 days. Y 05/01/2001 05/02/2001 1 NONE PUB PUB NONE NONE NONE 1
0170373 05/30/2001 VA 2.0 2 .2 M 05/17/2001 On 5/12/01, low-grade fever, runny eyes, coughing and runny nose. On 5/14/01, placed on antibiotic for "pus pocket" throat. On 5/16/01, rash and antibiotic stopped. On 5/18/01, clear. Y Y 05/07/2001 05/12/2001 5 PUB PUB NONE 1
0170374 05/30/2001 NC 4.0 F 05/03/2001 Left thigh rash, 8cm X 8cm. Y Y 05/01/2001 05/03/2001 2 NONE PVT PUB NONE NONE NONE 1
0170375 05/30/2001 CO 12.0 12 M 05/22/2001 4.5cmx4.5cm erythema around injection site on right deltoind. Left warm to touch; mild swelling Td site. Treated with Benadryl 25mg PO Q 4-6 hours, cold compresses. Keflex 250/5 2tsp PO if redness worsens. Y 05/16/2001 05/18/2001 2 PVT PVT NONE NONE NONE 1
0170376 05/30/2001 WA 72.0 72 F 05/18/2001 Reaction to pneumonia vaccine given on 5/16/01. Y 05/16/2001 05/17/2001 1 PVT UNK 1
0170377 05/30/2001 WA 54.0 54 M 04/20/2001 No data provided. Y Y 03/06/2001 PUB PVT Lipitor Elevated cholesterol 1
0170378 05/30/2001 OR 1.5 1 .6 M 05/18/2001 Cellulitis of left anterior thigh (9cm X 5cm); developed on 5/16/01 with treatment on 5/17/01 with Augmentin X 10 days. Y U 05/15/2001 05/16/2001 1 PVT PVT Amoxicillin Sinusitis NONE 1
0170379 05/30/2001 AL 1.5 1 .5 M 05/22/2001 Mother stated child was given Tylenol that day. When pt got up on 5/18/01, he would not walk on leg and was irritable. His leg was swelled from thigh to knee and had a red area on left side of injection site. Mother took pt to MD who call HD and sent pt for PHN to see. Mother was instructed by MD to use cool compresses and give Motrin every 5-6 hours. PHN called GM on 5/21/01 and she stated pt was better and swelling had decreased. Y Y 05/17/2001 05/18/2001 1 PUB PUB AL0106 1
0170380 05/30/2001 WA 5.0 5 M 05/16/2001 Phone call from mom on 4/27/01. She described 2" X 1 1/2" slightly raised and red area on left arm. Warm to touch but not painful. She will continue to observe reactions and call if not improving. According to mom, the reaction was in area where the MMR vaccine would have been given. Y 04/24/2001 04/26/2001 2 NONE PVT PUB NONE NONE 1
0170381 05/30/2001 IN 4.0 1 .2 M 05/25/2001 Mother called at 14:00 today and stated she works in a daycare and the pt attends and there has been cases of varicella. He didn't complain of fever but started breaking out under arms, buttocks, behind ears, penis and back. Red, blisters, yellow fluid inside and itching. He has decreased appetite and tired. Received varicella on 8/20/97. Y 08/20/1997 PUB PUB NONE 1
0170382 05/30/2001 WY 3.0 3 M 05/04/2001 Red, swollen, hard leg with red blotches throughout the upper leg. U 05/02/2001 05/03/2001 1 PUB PUB NONE NONE 1
0170383 05/30/2001 MD 1.6 1 .6 F 05/20/2001 On 7/20/00, the day after receiving vaccines, pt was very irritable and sleepy. She slept nearly all day and then again at night. Her left leg and left arms were sore and red at the injection sites. On 7/21/00, 2 days, post vax, she developed a fever of 102.3F with it's highest at 103.1F. She began to cry for prolonged periods up to 8 hours. She also had intermittent screaming for no apparent reason. Over the next week, she continued to be very irritable and did not want to walk or use the stairs which she previously had done. She wanted to be very still and not moved around. She began to wake in the middle of the night several times, screaming and unable to go back to bed. On 7/29/00, her fever returned between 100F-102F (ax). She would still cry and scream and would arch her back and cry harder as if in a tantrum when anyone would try to comfort her. On 7/30/00, she developed a rash over her entire body. She was taken to the doctor and dx'd with a post vaccine varicella rash. She was put on steroids and Benadryl. On this same day, she stopped talking and her appetite continued to diminish. She stopped responding to loud noises or any sounds other than music from her favorite TV shows. She became glued to the TV set and did not want to do anything else. She seemed physically weak and when she did walk, it was an abnormal gait with 1 shoulder up and her head tilted to the side. She then started to put everything in her mouth, as if she were a baby again. She continued with the eczema, nasal congestion and other symptoms. On 9/23/00, she began to have a fever of 102 (ax), severe diarrhea 4-5 times a day, not eating well (drinking only) and began to pull at her left ear. She was rarely making eye contact. We thought her PE tubes may have been clogged and consulted her ENT. Two days later, still with diarrhea she had abdomen distention and she had open sores on her vaginal and rectal areas. She had brown drainage from her left ear. I insisted on taking her back to the doctor and he ordered stool cultures which were negative and assured me that everything was fine with her ears and that she was not dehydrated. I called again the next day, to the pediatrician's office and was very upset and expressing my concern regarding a change in my daughter's behavior and physical symptoms. The nurse assured me over the phone that the doctor would call me back if he felt it was necessary to see her. The doctor put her on Bactrim and suggested re-inserting the tubes since she was not responding to verbal stimuli, which she had done on 11/1/00. She awoke from anesthesia and was very upset, biting me and thrashing about. From 11/20/00 to 11/27/00, she started with a rash on her cheeks and a fever of 101F. The rash continued and the fever rose to 102.1F. She was lethargic and sleeping most of the time, off and on. She continued to have nasal congestion, no appetite and fever for the next few days. She began to have diarrhea again and was crying constantly for no apparent reason. She was dx'd with left otitis media and virus and placed on Suprax and fluids. On 12/14/00, she had same symptoms and was put on Ominicef and Floxin. She received Prevnar vaccine. One week later, she was unable to balance and was continuously falling. Her left ear had pus and was obstructed. The doctor ordered Garamycin drops and for the next month, several attempts were made to remove the obstruction to no avail. Her behavior continued to deteriorate and had a fit in the doctor's office and it took me 45 minutes to get her out of his office. On 1/11/01, she developed influenza. On 1/17/01, she had another PE insertion. On 2/12/01, she had a respiratory infection. On 2/8/01, she was seen by a pediatric neurologist and dx'd with an encephalopathy. She has seen a geneticist who indicated that she has a mitochondrial disorder which was likely caused by the DTAP, especially the Pertussis. She has seen an allergist and he noted the she demonstrates several allergic type reactions. Doc 198237 states that patient has a permanent metabolic disorder which will require drugs (medication) for the rest of her life. She continues to have sensory problems, auditory processing, speech,language and behavior problems to frustration. She is allergic to numerous foods.But she has improved since the incident. She has started to gain weight and grow again. She is severely behind her development as a result of the event. Y Y N 07/19/2000 07/21/2000 2 Occupational therapy, speech and language therapy, educational evaluations which were abnormal. CBC; Chemistry Panel; urine organic acids test; Lactic acid test; blood mercury; neurology; psychologist; immunologist; allergist; audiology exam; EEG; MRI and other lab tests. PVT PVT Nystatin for fungal infections, cortisone for severe eczema Rhinitis, severe fungal infection in groin and diaper area Allergies to milk, soy; severe eczema; recurrent otitis media X 10, chronic rhinorrhea; chronic allergic rhinitis ~Pneumo (Prevnar)~1~3.20~In Sibling 1
0170384 05/30/2001 IL 1.25 1 .2 M 05/15/2001 Father presented at approx. 15:55 on 5/10/01 stating "he just got his shots and I couldn't wake him! I saw him roll his eyes back and I couldn't wake him. I got so scared." The nurse ran to waiting room. I was paged and ran to clinic waiting room and the nurse and I assessed the pt. The nurse did a quick assessment and found the child to be in no acute distress. MD was advised of concerns and advised us to advise parents if child shows signs again to call him or go to the nearest ER. My part of assessment: Child awake, alert, respiration 28, pupils equal, skin warm and dry, color good, no erythema or swelling at injection sites on right leg or left thighs. Y 05/10/2001 05/10/2001 0 PUB PUB Tubersol/Conn/C0146AA/ID/RFA/0 previously NONE Head banging; Seizure at birth IL01017 1
0170385 05/30/2001 OH 1.2 1 .2 M 05/10/2001 The pt experienced an elevated low grade temp on 5/10/01. The pt experienced a fine red rash that appeared on 5/10/01 on the forehead and broke out on neck, abdomen and arms. On 5/11/01 the child felt warm. No phone for follow-up. 04/30/2001 05/10/2001 10 PUB PUB OH0028 1
0170386 05/30/2001 OK 4.0 4 M 04/30/2001 The pt experienced a reddened, swollen area that was 7 x 3 inches on right arm with vesicles surrounding injection site where bandaid adhered. Y Y 04/28/2001 04/29/2001 1 PUB PUB NONE 1
0170387 05/30/2001 OK 4.0 4 M 05/10/2001 The pt's left arm was swollen from the shoulder to the elbow. Severe erythema and fever was noted in the swollen area. The pt was referred to physician for follow-up and palliative care. Y U 05/08/2001 05/09/2001 1 PUB PUB NONE NONE NONE OK0123 1
0170388 05/30/2001 OK 36.0 36 F 05/10/2001 The employee complained of extreme lethargy and headache, nausea and vomiting, photophobia after taking hepatitis B vaccine. Y Y 04/30/2001 04/30/2001 0 PVT OTH Ultram, Motrin rheumatoid arthritis unspecified~Varicella (Varivax)~~36.00~In Patient OK0122 1
0170389 05/30/2001 OK 33.0 33 M 05/10/2001 Approximately 5-10 minutes after receiving the MMR and varicella vax, the pt complained of feeling hot, flushing, throat burning and intense itching. Decreased blood pressure at 84/50, nausea and vomiting and diaphoresis. Was transported to the ER for monitoring, IV and evaluation. Y Y 04/24/2001 04/24/2001 0 PVT OTH NONE NONE NONE unspecified~Vaccine not specified (no brand name)~~32.00~In Patient OK0121 1
0170390 05/30/2001 OK 4.0 4 M 05/04/2001 The pt experienced hives, was cranky, had fever, experienced redness and swelling of left deltoid at the injection site and heat at site. Y Y 05/02/2001 05/03/2001 1 PUB PUB OK0124 1
0170391 05/30/2001 KY 4.0 4 F 05/24/2001 The pt experienced hives on abdomen and back 24 hours post vax. Atarax was prescribed for itching. No SOB, cyanosis or other symptoms reported. Y Y 05/22/2001 05/22/2001 0 strep screen PUB UNK NONE NONE NONE KY2001036 1
0170392 05/31/2001 VA 0.5 0 .5 M 05/25/2001 Vomiting and weakness occurred on 4/25/01. Visited ER on 4/26/01 at 03:00 and transferred to ER of another hospital at 10:30 on 4/26/01, Pt died at hospital. Y 04/26/2001 N 04/23/2001 04/25/2001 2 Leukocytosis on WBC and non-specific radiological findings PVT UNK NONE 1
0170393 05/31/2001 FL 0.7 0 .6 M 05/16/2001 The pt experienced convulsions, eye contusion, lethargy, encephalitis, high pitched screaming, pneumonitis, apnea, anaphylaxis, sclerosis. Autopsy states cause of death as a result of blunt head trauma injuries. Autopsy reports contusions of the scalp, fractures of the parietal bone, subdural hematoma, subdural hemorrhage, subarachnoid hemorrhage, retinal hemorrhages, hemorrhage in the optic nerve, cerebral edema, contusions, abrasions. Y 01/09/1999 Y Y Y 2 Y N 01/08/1999 01/08/1999 0 PVT PUB Tylenol Gastroenteritis and vomiting for 1 day NONE ~DTaP (no brand name)~~2.00~In Sibling 1
0170394 05/31/2001 KY 0.6 0 .6 M 05/22/2001 On 3/8/01 at 20:00, had grand mal seizure when lying in grandmother's lap, 30 minutes after a bath. Head went back, eyes rolled back, clonic movements all extremities and cyanotic. Grandmother gave CPR. All of episode lasting 3-5 minutes. He was lethargic afterwards. No fever. Saw in ER. On 3/11/01, 30 minutes after a bath, had a grand mal seizure. No CPR. Seen in ER and hospitalized 3 days. On 3/12/01, had a seizure lasting 1-2 minutes. Dx'd with epilepsy. Put on Phenobarbital. Y Y 3 Y 02/26/2001 03/08/2001 10 EEG; Blood work; Cat Scan; X-rays PUB UNK NONE NONE father has hx of petit mal seizures as baby KY2001037 1
0170395 05/31/2001 PA 69.0 69 M 05/01/2001 Tiredness, weakness, achy, severe weakness, sweating and hospitalized on 10/26/01 through 10/28/01. Similar occurrence approx. 2/3/00. Tires easily and cannot drive a distance and had blurred vision. Symptoms began on 6/15/00. The 60 day follow-up states that the pt is very tired and weka; pain in joints; hard walking and bending legs; cannot drive far (tires out). The follow-up states additional symptoms; severe cramps and pain in legs, arms, etc. The annual follow up received on 6/19/02 states tiredness, weakness, achy joints, muscles, severe weakness and sweating, blurred vision, cannot drive far, severe cramps, short memeory los (very weak and tired). Searching for anther doctors for help. Y Y 3 N 06/13/2000 06/15/2000 2 PVT OTH Zocor, Allegra NONE Allergies 1
0170396 05/31/2001 LA 0.3 0 .4 M 05/25/2001 At 18:00 on 2/10/01, pt had temperature and the fontanel was raised and firm. At 08:00 on 2/11/01, pt was brought to ER and about 11:00 on 2/11/01, pt underwent a CT Scan that showed hydrocephalus. An MRI was performed on pt on 2/12/01 at 13:00 and the report stated that pt had prominent hydrocephalus. Pt was seen by a neurosurgeon on 2/11/01 and started a treatment of acetazolamide. He took this for approx. 3 months. After 1 week of last dose, another MRI was done on 4/27/01 and still shows hydrocephalus. Follow up information received 09/18/02 states "(the child) is developing normally without any delays. His neurosurgeon has told me that she is no longer needs to see him,unless something happens that causes his hydroceohalus to begin progressing. I am intersted in trying to get another MRI done to see (the child) present condition.". The annual follow-up states "pt still has hydrocephalus, eventhough it is not progressing. Pt is developing normally without any delays. His neurosurgeon has tol dme that she no longer needs to see him, unless something happens that causes his hydrocephalus to begin progressing. I am interested in trying to get another MIR done to see pt's present condition." MRI done 04/21/2001 shows improvement from 02/12/2001 study, however prominent ? persuits despite Tx w/ acetazolamide.Pt was seen in ER on 06/03/2001 for a fever of 101.3. Some nasal congestion. Dx "virus", P O good, well hydrated, D/C'd to home. Y Y Y N 02/09/2001 02/10/2001 1 CT Scan-showing hydrocephalus; MRI-showing severe hydrocephalus on 2/12/01; on 4/27/01 MRI-still showing hydrocephalus, slightly improved but still prominent PVT PVT NONE Cold NKA 1
0170397 05/31/2001 TX 0.2 0 .2 M 05/20/2001 Pt's bowel ceased working, 12 hours, post vax. Pt had 2 grey, foaming, bubbly stools, then nothing for 17 days. Per doc 197792, patient still suffers from significant intestinal difficulties, food allergies and has developmental delays. Y U 12/14/1999 12/14/1999 0 PVT PVT NONE NONE NONE 1
0170398 05/31/2001 PA 7.0 7 M 05/22/2001 On 5/11/01, mother noted bruising, small purpuric lesions of legs, trunk and face. Pt was admitted to a hospital for 2 days. Given IV therapy. diagnosed with thrombocytopenia and pancytopenia Y 2 Y 05/03/2001 05/11/2001 8 CBC/Diff; PT/INR/PTT PVT PVT NONE Pyloric stenosis S/P corrected 1
0170399 05/31/2001 VA 0.46 0 .5 F 05/18/2001 Pt was stable in PICU and preparing for discharge. Received immunizations and within 24 hours, became hypotensive, tachycardic, febrile-shock state. All septic workup was negative. Required ionotropic support X 48 hours. Returned to baseline. From the acute event, child will not recover from the congenital problems. She is presently still on vent at hospital for rehab. Y Y Y Y 05/08/2001 05/09/2001 1 Sepsis workup-neg (CBC; Chemistries; blood cx; CSF count/cx; urine cx MIL MIL Methadone, Valium, Zantac, Phenobarbital, Lasix, Poly-Vi-Sol Pierre-Robin; Neuronal Migration Defect; Pulmonary Insufficiency 1
0170400 05/31/2001 TX 0 .0 F 05/18/2001 Mother noted poor feeding, vomiting X 2, lethargy and fever about 4-5 hours, post vax. Fever to 101F. Admitted to the hospital for suspected sepsis (ruled out). Y 2 Y 04/30/2001 04/30/2001 0 CBC; WBC-6.0 (20 segs/59 lym/20 mo/1 eo); Cath U/A-1.005/5.0/0-5 WBC/0-5 RBC/all neg PVT PUB NONE NONE NONE 1
0170401 05/31/2001 IA 0.7 0 .7 F 05/22/2001 Mother phoned on 5/18/01 and stated child started "non-stop" crying on the evening of 5/17/01 at 19:00 and "acted like hurt". Not usual cry, high-pitched, did go to sleep but awoke during the night and took 1 hours to calm. No fever. Fussy Friday; awoke Saturday and was "ok". Had diarrhea and gas on Saturday, 5/19/01. On 5/22/01, had cold and cough symptoms. Y 05/17/2001 05/17/2001 0 NONE PUB PUB NONE NONE NONE 1
0170402 05/31/2001 OH 1.25 1 .3 M 05/24/2001 At 17:00, started with temperature of 103.5F. 101.9F (ax). Irritable. Given Motrin and temperature went away and down in the morning. Y 05/16/2001 05/16/2001 0 PUB UNK NONE NONE 1
0170403 05/31/2001 MI 0.2 0 .2 F 05/22/2001 Seems lethargic, sleepy, relaxed, hypotonic, not fussy, no fever, lasted 4-5 hours, post vax. Y Y 05/09/2001 05/09/2001 0 NONE PVT UNK NONE NONE 1
0170404 05/31/2001 SC 4.0 4 M 05/15/2001 5/9/01 at 10:50 AM, phone call from mother, face is red (looks like a rash) swelling under one eye. No pain on fever. Will give Benadryl. On 5/11/01, I called mother and still face is red, no swelling pain. Had low fever last night and the night before. Gave Motrin and giving Benadryl every 4 hours and since 5/7/01. Child active with no complaints. On 5/15/01, child with non redness and doing well. Y 05/09/2001 05/09/2001 0 NONE PUB PUB Albuterol NONE Breathing problems (in winter time, use albuterol breathing machine) SC0129 1
0170405 05/31/2001 SC 0.5 0 .5 M 05/14/2001 Dad took infant via EMS to ER at 03:00 on 5/12/01 with vomiting, dry heaves, fever of 101.4F, fussy, pale and apparent difficulty breathing. When EMS arrived, infant had short, shallow breathing per dad. Had shots on 5/11/01. Information taken over the phone. Y Y 05/11/2001 05/12/2001 1 CXR-nml PVT OTH NONE NONE Atopic dermatitis and Kuliara SC0128 1
0170406 05/31/2001 WI 1.0 1 .0 M 05/21/2001 104F fever, within 24 hours. Rash, within 48 hours. Was seen on 5/18/01 and dx'd with bilateral ear infections. Y 05/14/2001 05/15/2001 1 PVT PUB Corrected hypospadias Rash~Vaccine not specified (no brand name)~~0.00~In Patient 1
0170407 05/31/2001 ME 0.3 0 .3 M 05/23/2001 Prolonged crying and screaming (1 1/2 hrs) approx. 4-5 hours, post vax. Resolved in car en route to ED: not seen. Y 05/17/2001 05/17/2001 0 NONE PVT PUB Tylenol prn NONE NONE 1
0170408 05/31/2001 CA 0.2 0 .2 M 05/18/2001 Approx. 1 minute, post vax of Prevnar, pt developed generalized redness with numerous hives all over. Y 05/18/2001 05/18/2001 0 NONE PVT PUB NONE NONE NONE 1
0170409 05/31/2001 TX 0.75 0 .7 F 05/22/2001 Hives all over body except face and back, for 2 days; 1 day after shot. Also, diarrhea for 2 days. Y 04/20/2001 04/21/2001 1 MIL MIL 1
0170410 05/31/2001 DE 1.0 0 .9 M 05/20/2001 Post vax, that day, developed red, hot and bumpy rash on trunk and in corners of arms and legs. Was not scratching. Given Benadryl with no help. Temperature not taken. Rash persisted for about 1 week. Also had quarter-sized swelling at the injection site. Y 03/20/2001 03/20/2001 0 NONE PVT PVT NONE NONE 1
0170411 05/31/2001 WA 0.5 0 .5 F 05/22/2001 Urticaria, diffusely, over entire body, worse in left thigh area at site of Prevnar injection. No respiratory distress. Onset of symptoms approx. 8 hours, post vax of DTAP #3, Prevnar #3 and HIB #3. Y 04/23/2001 04/23/2001 0 NONE PVT PUB NONE NONE 1
0170412 05/31/2001 MS 1.25 1 .3 M 05/22/2001 Pt came in on 5/18/01, complaining of stomachache, low-grade fever, crying, rubs head, not himself, decreased appetite, dry heaves last night. On Augmentin for right otitis media, rash on trunk on 5/21/01. Y Y 05/14/2001 05/17/2001 3 PVT PVT Right otitis media 1
0170413 05/31/2001 CA 6.0 6 M 05/22/2001 Post vax, pt slept mostly the whole day, then woke up complaining of some swelling and tenderness on the injection site. He was asymptomatic after 48 hours. Y 08/14/2000 08/14/2000 0 NONE PVT UNK NONE 1
0170414 05/31/2001 OH 0.5 0 .4 M 05/22/2001 Mother stated child was hyporesponsive after Prevnar (4 month shots) last time X 6 hours. NP spoke to mom, 4 hours, post vax, 6 month shots and he's doing fine. Y 03/30/2001 03/30/2001 0 NONE PVT PVT NONE NONE NONE 1
0170415 05/31/2001 NJ 0.25 0 .3 M 05/25/2001 Approx. 5 minutes, post vax of Prevnar, baby had red (small) blotches around nose and in hair line. No other symptoms noted. Normal temperature. The MD states "hives". Y 05/25/2001 05/25/2001 0 PVT PVT 1
0170416 05/31/2001 GA 0.3 0 .3 M 05/23/2001 Pt came in for 6 month check-up before given 6 month immunizations. The mother states the last time the pt was her on 3/27/01, he had a reaction that night to the immunizations. She states he screamed inconsolably for 7 hours, fever of 102F, site hot and red. The pt was taken to ER, that evening, and was told he had an allergic reaction to immunizations. Y Y 03/27/2001 PVT PUB NONE NONE 1
0170417 05/31/2001 HI 1.5 1 .5 M 05/23/2001 About 1-1 1/2 hours, post vax. noted to be limping. Mom then noted right thigh to be swollen and tender. Tried to apply cool compress on my advice but too tender. Tylenol was given. On exam, 10cm swelling and redness. Tender but limp is very mild. Y U 05/23/2001 05/23/2001 0 NONE PVT PUB NONE NONE 1
0170418 05/31/2001 NJ 22.0 20 M 06/25/2001 This report was received from the vaccinee and from the vaccinee's mother and has not been verified by a physician or other healthcare professional. His medical history included mononucleosis, "recent" conjunctivitis, chondromalacia and 2 episodes of Lyme disease. He had Lyme arthritis at the age of 11, with hospitalization and treatment with Rocephin. He again had Lyme disease in high school. The vaccinee did not have gout, psoriasis or Crohn's disease. There was no family history of rheumatoid arthritis or lupus. The pt admitted "heavy" involvement in contact sports, including football, wrestling and track. There was no illness at the time of vaccination. On 02/16/2000 and 03/22/20000, the pt received his 1st dose of Lymerix. On approx. 5/22/00, the pt began to experience right knee pain. There was no swelling; there was pain with walking and running and with getting out of bed in the morning. X-rays and MRI revealed a "spot/cyst" on the right femur. A bone scan was performed on 5/20/01; results were not known to the pt. The 2nd and 3rd doses of Lymerix were administered on approx. 10/2/00 and approx. 4/2/01, respectively. As of 5/22/01, the event was resolved. On follow-up received on 06/15/2001, the physician indicated that "no adverse reactions were reported to me." Y N 03/22/2000 05/22/2000 61 X-rays and MRI-"spot/cyst" on right femur; Bone scan-results unknown OTH OTH NONE Chondromalacia; Conjunctivitis; Lyme arthritis; Lyme disease; Mononucleosis 20010126971 1
0170419 05/31/2001 ID 52.0 52 F 01/30/2001 The pt experienced hives on the left side of the face and neck. Y 12/12/2000 12/12/2000 0 PUB PUB allergy to Keflex, PCN, Cephalasporin 1
0170420 05/31/2001 WA 4.0 4 M 05/23/2001 36 hours post vax, the pt experienced erythema and edema with urticaria extending from injection site to just above the elbow according to Mom. There was a small knot at the injection site. No other symptoms were observed. Treated with Ice, Benadryl and Tylenol. Y 05/21/2001 05/23/2001 2 PVT PUB Pulmocort asthma 1
0170421 05/31/2001 WI 47.0 47 F 05/24/2001 On 5/17/01 the pt was achy all over, warm and tire, in the afternoon, increased pain, hot, red, firm to the touch at the injection site. On 5/18/01 the pt was unable to lift injected arm more than 90 degrees from torso. Pain, hot red, firmness continues. On 5/19/01 and 5/20/01 decrease in symptoms and increase in ROM. Treated with Tylenol, Aleve OTC medication. Y 05/16/2001 05/17/2001 1 NONE PVT PVT Synthroid, BC Pills NONE Hoshimotos Struma 1
0170423 05/31/2001 IN 1.6 1 .7 F 05/22/2001 Vaccine associated measles (Rubeola), fever X 5 days followed by morbilliform rash on face, trunk and extremities; decreased appetite and some congestion and watery eyes. U 05/10/2001 05/17/2001 7 NONE PVT OTH NONE Otitis media NONE 1
0170424 05/31/2001 FL 1.0 1 .0 M Developed chickenpox. U 06/07/1996 05/22/2001 1810 PVT PVT NONE 1
0170425 05/31/2001 SC 11.0 10 F 05/02/2001 Two inch diameter of redness around site of injection with soreness at site on right arm. Using cold pack and Tylenol. Y 04/30/2001 04/30/2001 0 PUB PUB NONE NONE SC0131 1
0170426 05/31/2001 SC 12.0 12 F Hives over entire body, more so on face and chest with some swelling under eyes. Denies SOB or other discomfort. Time course-2 hours, post vax. Treated with Benadryl 50mg IM in right deltoid. Notified MD at 15:15. Y 05/17/2001 05/17/2001 0 PUB PUB NONE NONE NONE SC0130 1
0170427 05/31/2001 CO 4.0 4 F 05/23/2001 Two, 1cm red and warm nodule. Possible infection. Y 05/22/2001 05/23/2001 1 PVT PVT NONE 1
0170428 05/31/2001 NJ 0.9 0 .9 F Pt had fevers, sores in her mouth, crankiness, not eating, drinking only water, swelling in her throat and it happened almost immediately. Y Y 05/02/2001 05/03/2001 1 UNK UNK 1
0170429 05/31/2001 VA 6.0 1 .5 F 05/22/2001 Pt got chickenpox. Y 02/21/1996 05/21/2001 1916 PVT PVT 1
0170430 05/31/2001 FL 21.0 21 M 05/18/2001 After about 45 minutes, post vax, I started to have a sick stomach and a phlegm in my throat causing me to cough and have difficulty breathing. I drank some juice and ate some bread to settle my stomach but I still was sick. After I got sick, I came to the clinic and after a little while I started feeling better. I could breath fine but my stomach was still a little upset. I feel better, though. Pt complained of single episode of vomiting with mild dizziness, abdominal cramps and extreme nausea. Pt complained of "felt phlegm" in throat with feeling a need to take a deep breath every couple of minutes. Pt's skin was slightly pale. No diaphoresis, flushing or systemic itching. No local reaction of injection site. Pt denies any self medication for nausea or cramps other than juice and bread. Pt taken to treatment room, placed in position of comfort. Pts symptoms resolved on presentation. Pt sent home with Epi-Pen and po Benadryl. Referred to allergy for evaluation. Y Y 05/18/2001 05/18/2001 0 P O2-94%; BP MIL MIL NONE possible "slight cold" NONE 1
0170431 05/31/2001 IL 1.25 1 .7 M 05/17/2001 24 hours, post vax, pt brought in with 8-10cm of erythema and hyperemia to right thigh. Pt to use Benadryl and ice. Y Y 05/16/2001 05/17/2001 1 PVT PVT NONE 1
0170432 05/31/2001 CA 27.0 27 M 05/17/2001 Feeling of heaviness in the back at shoulders, headache, sore throat heaves with nausea, trembling (very little) occurred several hours, post vax, lasting about 3 hours. Finally, had unusual occurence of a nose bleed at 04:00 on 5/15/01. U 05/03/2001 05/03/2001 0 NONE PVT PVT NONE Latex sensitivity; (+) PPD 1
0170433 05/31/2001 CA 60.0 59 F 05/22/2001 Local induration, redness and swelling. Y 05/03/2001 05/04/2001 1 NONE PVT UNK NONE NONE 1
0170435 05/31/2001 CA 26.0 26 F 05/22/2001 Local induration and erythema with discomfort. Seen on the 7th day and was resolving with 4cm X 3cm diameter area. Y 05/15/2001 05/16/2001 1 NONE PVT UNK NONE NONE 1
0170436 05/31/2001 CA 5.0 5 F 05/18/2001 Right anterolateral mid arm swollen and itching and hot. DTAP was given 2 days ago. Y Y 05/15/2001 05/17/2001 2 PVT PUB NONE NONE 1
0170437 05/31/2001 LA 1.7 1 .7 F 05/10/2001 Pt developed several "spots" around neck and trunk and became flushed with a temperature of 101.5F, on the afternoon of 3/11/01. The spots darkened and spread over the next 2 days to her entire body with the densest rash on the neck and chest. Pt had a mild temperature of 101F-102F over those 2 days. The rash gradually lightened over the next 5 days. Y 03/02/2001 03/11/2001 9 NONE PVT PVT NONE NONE NONE 1
0170438 05/31/2001 WA 48.0 48 M 05/24/2001 Left deltoid pain noted about 36 hours, post vax. Symptoms of malaise, arthralgias, general fatigue. No wheezing, SOB or itching. U 05/22/2001 05/24/2001 2 NONE MIL MIL lisinopril NONE NONE 1
0170439 05/31/2001 OH 1.25 1 .3 M 05/25/2001 Redness, swelling and warmth at injection site with irritability and a fever of 102F. Y Y 05/21/2001 05/22/2001 1 NONE PVT PVT NONE NONE NONE 1
0170440 05/31/2001 OR 20.0 20 F 05/24/2001 The pt experienced nausea, vomiting (1 time) diarrhea (1 time) occurring 3-4 hours post vax. U 05/23/2001 05/23/2001 0 NONE OTH PVT 1
0170441 05/31/2001 GA 5.0 5 F 05/24/2001 Local reaction with swelling without redness, warmth or tenderness. Y 05/22/2001 05/23/2001 1 PVT PUB NONE NONE NONE 1
0170442 05/31/2001 GA 4.0 4 F 05/17/2001 On 5/17/01, aunt called to report swelling, tenderness and redness in left arm to elbow. Aunt states it "looks almost like a burn area". Instructed aunt to use cold compress/ice to affected area and fever medicines for fever. Referred child to child's doctor or ER for evaluation per the RN. Child evaluated by FMC ER doctor on 5/17/01 and doctor told parent that it was a local reaction per RN. Y U 05/15/2001 05/16/2001 1 PUB PUB NONE NONE 1
0170443 05/31/2001 CA 0.3 0 .4 M 05/10/2001 30 minutes, post vax, pt developed eyelid swelling that lasted 30 minutes. The pt recovered completely. On 4/7/01, HIB skin testing was given and as it was negative, pt was vaccinated without incident. Further testing is pending. This case illustrates the clinical problem of having multiple vaccines given on the same day: when there is an adverse reaction, all of the vaccines become suspect as the causative agent; even if the event cannot be proven to be due to vaccination. Y 10/25/2000 10/25/2000 0 RAST to egg yolks-neg (Class 0); IgE-99; HIB skin testing-neg PUB PUB NONE Atopic dermatitis Atopic dermatitis 1
0170444 05/31/2001 CO 16.0 16 F 05/22/2001 Approx. 45 minutes, post vax, pt experienced erythematous, indurated local reaction followed by cough, wheezing, shortness of breath and urticaria. Required ER visit to receive epi and breathing treatments. Y Y 05/16/2001 05/16/2001 0 NONE PUB PUB NONE Hay fever and seasonal allergies. 1
0170445 05/31/2001 CA 4.0 4 F 05/16/2001 Cellulitis noted, 3 days, post vax, at injection site of DTAP. Pt given Keflex Y 05/11/2001 05/14/2001 3 PVT PVT PPD/Parkdale/01060P/LFA/1 previously 1
0170446 05/31/2001 MA 5.0 5 F 05/22/2001 "Chickenpox" looking rash on back, mainly under right scapula. 7 or 8 pox on left side of back. No cold symptoms, fever or pain. Very itchy. Treat with Aveeno bath and Benadryl. N 05/08/2001 05/22/2001 14 PVT PUB 1
0170447 05/31/2001 MA 1.0 1 .0 F 05/24/2001 20 or so pox on trunk and thighs. A couple on arms. First ones to appear have broken open and scabbed over. No s/s itching. No treatment at this time. U 05/07/2001 05/23/2001 16 PVT PUB 1
0170448 05/31/2001 CA 4.0 4 F 05/24/2001 24 hours post vax, the pt experienced urticaria. Y Y 05/21/2001 05/22/2001 1 PVT UNK Acetaminophen NONE bronchopneumonia treated with Amoxil 1
0170449 05/31/2001 CA 23.0 23 F This patient complained of dizziness, weakness, and swelling of the pharynx. PE - WNL. No evidence of pharyngeal edema. Normal VS. The patient was monitored for 1 hour and patient is feeling better. The patient also observed to have intermittent left leg twitching. No previous history of seizure disorder. Y 05/29/2001 05/29/2001 0 6 readings taken. Average BP 128/83, Average pulse 67. OTH OTH NONE NONE NONE 1
0170450 05/31/2001 IL 1.0 0 1 M 05/30/2001 On 5/22/01 the pt broke out with modified chicken pox lesions. Y Y 09/01/1999 05/22/2001 629 NONE PVT PVT NONE NONE cleft lip and palate 1
0170500 05/31/2001 TX 9.0 9 F 05/23/2001 Immediately post vax the pt became pale, sweat, stated she felt sick and her heart rate fell to less than 40. Her blood pressure was normal by the time the nurse was able to obtain a reading. The pt sought unspecified medical attention. Follow up information indicates that the symptoms lasted 1-2 minutes and she stated she felt better. After a few minutes she again started to get pale, sweat, and her pulse was 43. The pt was placed with her feet elevated and an ambulance was called. The pt was transferred to a hospital. It was noted that the pt felt better and was able to walk to the ambulance. The pt recovered the same day as onset. No further information is expected. Y Y 04/18/2000 04/18/2000 0 blood pressure normal; total heartbeat count 43; total heartbeat count less than 40. UNK UNK UNK UNK WAES00041792 1
0170501 05/31/2001 4.0 M 05/23/2001 Information has been received from a physician concerning a 4 year old male pt who on 5/5/00 was vaccinated with 1 dose of Hep-B virus vaccine inactivated. Concomitant therapy included cefaclor and it was noted that the pt has tolerated cephalosporin antibiotics well in the past. On 5/5/00, the pt experienced "a generalized urticarial rash". He was taken to a local ER for treatment. Additional information has been requested. Y U 05/05/2000 05/06/2000 1 OTH OTH Cefaclor UNK WAES00050865 1
0170502 05/31/2001 FL 45.0 45 F 05/23/2001 Information has been received from a 45 year old female with an allergy to acetaminophen + oxycodone hydrochloride (Percocet) who on 5/8/00 was vaccinated with Hep-A virus vaccine inactivated. Concomitant therapy included alendronate sodium (MSD). On 5/10/00, the pt experienced nausea, sore throat, and was "very, very tired". She had to "slap her face to stay up". No further information is available. U 05/08/2000 05/10/2000 2 OTH OTH Fosamax Drug allergy WAES00051443 1
0170503 05/31/2001 TX 17.0 M 05/23/2001 Information has been received from an NP concerning a 17 year old male who was vaccinated with Hep-A virus vaccine inactivated. In 2000, the pt experienced elevated bilirubin levels. Lab evaluation also revealed AST and ALT normal. It was noted LFT's would be checked in 1 month. Medical attention was sought. No further information is available. Y U Serum direct bilirubin-elevated; Serum alanine and aspartate-both normal OTH OTH UNK UNK WAES00053061 1
0170505 05/31/2001 CA 5.0 M 05/23/2001 Information has been received from a PA concerning a 5 year old male pt who on 6/13/00 was vaccinated with Hep-A virus vaccine inactivated. The same day of vaccination, the pt had a tuberculin skin test (results not reported). On 6/15/00, the pt presented with an "itchy, generalized rash all over his body with pustules on his chin." Unspecified medical attention was sought. Additional information has been requested. Y U 06/13/2000 06/15/2000 2 OTH OTH Tuberculin skin test on 6/13/00 (tuberculin purified protein)-results no reported UNK WAES00061760 1
0170506 05/31/2001 NY U 05/23/2001 Information has been received from a pharmacist concerning a pt who is "believed to be HIV (+). On an unspecified date, the pt was vaccinated with a 2nd dose of Hep-A virus vaccine inactivated. The reporter stated that, on an unspecified date, antibody titer results "did not show immunity after 2 dose series". The pt sought unspecified medical attention. Additional information has been requested. Y U Serum Hep-A did not show immunity per antibody titer OTH OTH UNK Human Immunodeficiency Virus (+) WAES00062070 1
0170507 05/31/2001 CA M 05/23/2001 Information has been received from a physician concerning a male who is an International "adaptee" who on 6/1/00 was vaccinated with 1 dose of Hep-A virus vaccine inactivated. Three weeks later, the pt had a full hepatitis panel done and was found to be positive for Hep-A IgM. The pt had no signs or symptoms and his liver function tests are normal. The pt's sister also underwent a full hepatitis panel, results unspecified. Medical attention was sought. Additional information has been requested. Y U 06/01/2000 06/22/2000 21 Diagnostic lab on 6/22/00-full hepatitis panel; Hepatic function tests on 6/00-normal OTH OTH UNK UNK WAES00064315 1
0170508 05/31/2001 IN M 05/23/2001 Information has been received from a physician concerning an adult male who was vaccinated with one dose of Hepatitis A virus vaccine inactivated. Thirteen days post-vaccination the patient developed a headache so severe he had to be hospitalized. An MRI was performed to r/o an aneurysm, however, at the time of reporting no results were available. The headache "has lasted for about one week now". Additional information has been requested. Y Y U MRI - Results not available. OTH OTH UNK UNK WAES00052018 1
0170522 05/31/2001 CA 3.0 M 05/23/2001 Information has been received from a physician concerning a 3 year old male pt who on approx. 6/13/00, was vaccinated with 1 dose of Hep-A virus vaccine inactivated. Approx. 4 days, post vax, the pt experienced a "skin reaction" characterized by a "general papular, erythematous rash". Unspecified medical attention was sought. Additional information has been requested. Y U 06/13/2000 06/17/2000 4 OTH OTH UNK UNK WAES00070241 1
0170523 05/31/2001 UT U Information has been received from a women in a physician's office concerning 6 pts who were vaccinated with Hep-A virus vaccine inactivated. In 1996, the pt's failed to seroconvert. Additionally it was noted that the pt's failed to seroconvert after therapy with Hep-B virus vaccine, recombinant (MSD) (WAES 00070242). Additional information has been requested. Y U Diagnostic lab 1996-neg Hep-A antibody titer OTH OTH UNK UNK WAES00070361 1
0170524 05/31/2001 CA F 05/23/2001 On 7/5/00 the pt developed abdominal pain. The pt sought medical attention and was diagnosed with hepatitis A. Confirmatory tests are pending. Additional information is expected. Y U 05/17/2000 07/05/2000 49 diagnostic laboratory - pending OTH OTH UNK colon polyp WAES00081028 1
0170525 05/31/2001 CA 13.0 F 05/23/2001 Subsequently the pt developed "hepatitis-like" symptoms. The pt sought unspecified medical attention. Additional information has been requested. Y U OTH OTH UNK UNK WAES00090081 1
0170526 05/31/2001 IL 21.0 F 05/23/2001 Two months post vax, the pt experienced jaundice and increased LFT's. Unspecified medical attention was sought. Additional information has been requested. Y U LFT - increased UNK UNK prednisone hepatitis WAES00090657 1
0170527 05/31/2001 WI 48.0 M 05/23/2001 Information has been received from a registered nurse concerning a 48 year old male with dermatitis and no known drug allergies who was vaccinated with a 1st and 2nd dose of Hepatitis A virus vaccine inactivated on 03/07/00 and 09/15/00, respectively. Subsequently on 09/26/00, the patient presented to the physician's office with severe dermatitis that may require hospitalization. It was reported that the patient experienced a rash after the 1st dose in March 2000, however neglected to inform the health care professional before administration of the 2nd dose. Follow-up information from the physician indicated that "she didn't think that this was an adverse event. The patient's dermatitis has been present for years with a recent flare after the vaccine. It was reported that the dermatitis was still flaring, but was not related to the vaccine". No further information is expected. Y N 03/07/2000 OTH OTH UNK Dermatitis WAES00092279 1
0170528 05/31/2001 CA F 05/23/2001 The pt experienced a fever, achiness, and body pain. Unspecified medical attention was sought. Additional information has been requested. Y U OTH OTH UNK WAES00101118 1
0170529 05/31/2001 M 05/23/2001 Information has been received from a physician concerning a fellow male employee who was vaccinated with the 1st dose of Hepatitis A virus vaccine inactivated. Subsequently, the patient developed Hepatitis A after he should have received the 2nd dose of the vaccine. Additional information has been requested. U OTH OTH UNK UNK WAES00101738 1
0170530 05/31/2001 TN 11.0 F 05/23/2001 The pt vomited several hours after receiving a hepatitis A vaccine given at another health care providers office. No further information is available. U UNK UNK UNK UNK WAES00110577 1
0170531 05/31/2001 TX 6.0 6 F 05/23/2001 Information has been received from a registered nurse and a physician's office concerning a 6 year old Caucasian female with no known allergies, who on 10/06/00, was vaccinated with Hepatitis A virus vaccine inactivated. On 10/27/00, the patient experienced stomach pain and stomach cramping. Unspecified medical attention was sought. Subsequently, the patient recovered from stomach cramping. Additional information has been requested. Y Y 10/06/2000 10/27/2000 21 OTH OTH UNK UNK WAES00110830 1
0170532 05/31/2001 TX 59.0 57 M 05/28/2002 The patient developed Hepatitis A. The patient sought unspecified medical attention. IN FOLLOW-UP information, the reporter stated "that the patient was treated and recovered, however he couldn't confirm if the patient had Hepatitis A". FOLLOW-UP information from the medical records, dated 12/18/00, indicated that the patient was a 59- year old female whoi has longstanding diabetes and was taking glimepirade (Amaryl) and Metformin hydrochloride(Glucophage). It was also indicated that she recntly had an area in breast taken out which showed a caricinoma in situ and was getting "tamoxifen" as a prophylaxis. Her liver enzymes were all normal on 03/20/00.The physician indicated that the patient developed some sort of "ill understood" syndrome of fever, chills and jaundice around 11/18/00. The patient's bilirubin went up to 10.3 mg/dl. Her alkaline phosphatases were up to around 460 U/L on 11/20/00 and her SGPT and SGOT were at 150 and 81 U/L respectively. Her Hepatitis panel was unremarkable, just showing an old proctective IgG antibody to help Hepatitis A virus but no acute antibody. Her liver enzymes gradually drifted down to normal by 12/04/00. Her alkaline phosphatases were down to 175 and SGOT and SGPT were normal. Her bilirubin was back down to 1.5. She never had any pain and never had any pruritus. she only had the fever and chills for a couple days. She was not taking any new medications during this period of time. The patient had a liver/spleen scan which showed a normally functioning and normal sized liver and spleen with no filling defects. The patient had a CT scan done on 11/20/00 , to rule out obstruction, and the liver and spleen were both normal in size, and no focal abnormalities were seen. There were some coincidental radiologic abnormality (possible artifact) was seen with some dilated tortuous veins around the spleen, and these were confluent with the left gonadal veins on the iliac crest. The physician indicated that the patient's physical examination revealed no sclerae icterus and a normal abdominal examination. The physician indicated that the patient had acute intrahepatic cholestasis which may have been of a viral etiology and had resolved. The physician stated "she doe not appear to have cirrhosis. She did not have a typical A,B or C acute Hepatitis, and this may have been related to some other virus as regards to the syndrome of fever, chills and acute development of jaundice that she experienced on 11/18/00". Abnormal labs from 11/20/00 included :glucose: 204 mg/dl; alkaline phosphate: 460 U/L; SGOT: 81 U/L; SGPT:150 U/L; T. bilirubin; 7:3 mg/dl; anti-HAV AB: positive. Y U 06/01/1998 11/18/2000 901 Abnormal labs from 11/20/00 included glucose; 204 mg/dl; alkalinf phosphates 460; U/L; SGOT: 81 U/L; SGPT: 150 U/L; T Bilirubin: 7.3 mg/dL; anti-Hav AB:positive: Computed Axial: 11/??/00- Normal -liver/ spleen scan; Blood glucose-11/20/00-204 mg/dL-(Normal range 65-109)-high; Serum direct bilirubin-11/20/00 -73 mg/dL-(Normal range 0.1-1.2) - high; serum direct bilirubin-11/18//00 - 10.3 mg/dL-Normal range 0.1 - 1.2; plasma alkaline-11/20/00 -460 U/L- Normal range 40-150)- high; Serum alanine -11/20/00-150 U/L - (Normal range 0-50) - high; Serum albumin- 11/20/00 -3.8 G/DL -(Normal range 3.5-5.5);Serum albumin/globulin -11/20/00 -1.3 -(Normal range 1.0 -2.3); Serum aspartate - 11/20/00-81 U/L- (Normal range 0-45) - high; Serum blood urea-11/20/00-13 mg/dL- (Normal range 5-26); Serum BUN/creatinine-11/20/00 -18.6 mg/dL; Serum calcium - 11/20/00- 9.6 mg/dL (Normal 8.5 -10.6); Serum chloride-11/20/00 -102 MEQ/l-(Normal range 96-109) OTH OTH Glucophage, Diovan. Diabetes mellitus NOS,Hypertension NOS. WAES00112142 1
0170533 05/31/2001 F 05/23/2001 Information has been received from a consumer concerning his wife who was vaccinated with Hepatitis A virus vaccine inactivated. The reporter stated, "that his wife experienced many adverse reactions similar to those listed in the PI (product Insert)". Additional information has been requested. U UNK UNK UNK UNK WAES00112353 1
0170534 05/31/2001 AZ 20.0 M 05/23/2001 Information has been received from a physician's assistant concerning a 20 year old male, who was vaccinated with Hepatitis A virus vaccine inactivated 20 years ago. Subsequently, the patient started blinking the next day and continues to do so. The patient sought unspecified medical attention. Additional information has been requested. The reporter also reported on the patient's niece WEAS # 00120970. Y U UNK UNK UNK UNK WAES00121089 1
0170536 05/31/2001 TX 6.0 6 M 05/23/2001 Information has been received from a physician and a medical assistant concerning a 6 year old male patient who on 01/22/01 was vaccinated in the left arm with a 1st dose of Hepatitis A virus vaccine inactivated. There was no concomitant medications. On 01/22/01, the patient developed a 4 to 5 inch long and 2 to 3 inch wide area of redness at the site of the injection, the site was warm to touch, and the area was "pruritic". On 01/25/01, the patient returned to the physician's office. Additional details regarding the outcome of the patient's experiences were not reported. additional information is not expected. Y U 01/22/2001 01/22/2001 0 PVT PVT NONE UNK WAES01012360 1
0170537 05/31/2001 WA 4.0 4 M 05/23/2001 Information has been received from an RN concerning a 4 year old white male with no known drug allergies who on 3/1/01 was vaccinated IM with Hep-A virus vaccine inactivated in his left thigh. There was no concomitant medication. On 3/5/01, the pt began vomiting. On 3/8/01, the pt ran a fever of 103F for 24 hours, with the highest fever reaching 104F. The pt had no fluid or food intake during this time period. On 3/8/01, the pt went to the ER and was given IV fluids only and sent home. The pt's symptoms resolved in 2 days and he recovered on 3/10/01. Upon internal review, the pt's fever of 103F was determined to be an "Other Medical Event". No further details were provided. Y Y 03/01/2001 03/05/2001 4 PVT OTH NONE UNK WAES01031022 1
0170538 05/31/2001 CO 3.0 U 05/23/2001 Information has been received from a physician concerning a 3 year old patient who on approximately 03/19/01 was vaccinated with Hepatitis A vaccine inactivated. On approximately 03/20/01, the patient developed a fine (slight bumps) non-pruritic rash above and below the site of the injection. The rash appeared within 36 hours post injection and "now" lasted into day four post injection. The reporting physician did not feel that this was a hypersensitivity reaction to the vaccine, but she thought it was most likely a contact dermatitis to the alcohol swab. As of 03/23/01, the patient had no other symptoms. The patient sought unspecified medical attention. No further information is available. Y U 03/19/2001 03/20/2001 1 OTH OTH UNK UNK WAES01033059 1
0170451 06/01/2001 CA 11.0 M 05/25/2001 There reportedly were no pre-existing medical conditions, allergies or concomitant medications. At the time of vaccination, the pt had the "flu". PCR (polymerase chain reaction) analysis was performed and the vaccinee was reportedly found to have chlamydia pneumonia. He was also found to have "low WBC". On 1/16/91, 1/6/94 and 1/29/01, the pt received his 1st, 2nd and 3rd doses of Engerix-B and approx. 3 days after his 3rd dose, on approx. 2/1/01, he was reportedly dx'd with chronic fatigue syndrome. Reportedly, he also had palpitations, muscle soreness, headache, "cognitive dysfunction", dizziness, night sweats and a rash on his trunk. The pt has been unable to attend school. As of 5/22/01, the rash had resolved. The outcome of the chronic fatigue syndrome, palpitations, muscle soreness, headache, "cognitive dysfunction", dizziness and night sweats was not specified. Because the pt was unable to attend school, the events are considered incapacitating and this report is considered serious. Y U 01/29/2001 02/01/2001 3 PCR-Chlamydia pneumonia; CBC-WBC "low" OTH OTH NONE Flu NONE 20010129221 1
0170456 06/01/2001 PA 0.6 0 .6 F 05/23/2001 On 3/1/01, the infant received her 3rd injection of Infanrix. On that date, she also received her 3rd injections of 7-valent pneumococcal conjugate vaccine (Prevnar, Lederle Labs) and inactivated poliomyelitis virus vaccine (IPOL, Aventis Pasteur). On 3/1/01, 3 hours, post vax, she developed a fever as high as 103.2F (rectally), irritability, decreased appetite and increased sleep. On 3/5/01, the 5th day of fever, the infant developed a rash. The fever abated, 1 day following the appearance of the rash. The infant was hospitalized for sepsis evaluation. Blood, urine, and CSF cultures were negative. She was treated with unspecified IV antibiotics, for 2 days. She was discharged from the hospital after a total of 3 days. On 3/13/2001, she was seen by her physician, who noted "a healthy child without sequelae." Y 3 Y 03/01/2001 03/05/2001 4 blood culture - neg, urine culture - neg, CSF culture - neg OTH OTH NONE 20010126121 1
0170458 06/01/2001 RI 1.25 M 05/17/2001 Pt received varicella vaccine at 15 month old office visit as part of routine immunization. Pt started with a few vesicles, 10 days prior to admission. Was treated with calamine lotion and Aveeno baths at home, but vesicles worsened. Lesions in oral cavity and throat. Pt brought th ER and admitted PICU for airway management and treatment of varicella, sepsis and pneumonitis. Treated with diphenhydramine, Acyclovir, clindamycin, ceftriaxone and acetaminophen. Discovered after admission was an underlying T-cell abnormality that would have made live vaccines contraindicated. Y Y 05/02/2001 UNK UNK 1
0170459 06/01/2001 MS 40.0 40 F 05/24/2001 This patient states she had a flu shot 12/07 and took Benadryl 12/07 for a rash to her face and redness to the injection site of the left upper arm. Complains of headache onset last night, diarrhea "x 32" today, some nausea, 2 cm area of induration / erythema at left brachium. The patient was discharged. Y Y 12/07/2000 12/08/2000 1 12/08 temp 98.8, P 92, R 32, BP 169/102, O2 Sat 100%. UNK UNK Benadryl, Pepto Bismol, Motrin, Valium, and Darvocet. Allergies: Lorcet, Toradol, Soma, Percocet, Ultram, and Duract. 1
0170460 06/01/2001 NY 11.0 12 M 05/24/2001 20 minutes, post vax, pt developed chest pain, difficulty breathing, edema of lips and eyelids and was treated with Albuterol Nebulizer. SC Epinephrine 0.3cc !:1000, PO Prednisone 60mg; SC Benadryl 50mg. Y 1 Y 10/12/2000 10/12/2000 0 PUB PUB Asthma 1
0170461 06/01/2001 CA 3.0 F 05/15/2001 The pt experienced a fever and seizure. Y Y Y 05/09/2001 CBC, Lytes, BUN/Creat, Glucose, Blood cultures, urine C&S, KUB PVT PVT NONE NONE NONE 1
0170462 06/01/2001 IN 0.2 0 .2 F 05/22/2001 3 weeks after shot, a chickenpox came up on chest and again about 2 weeks later on her leg (if rash flared up badly). On 11/20/00, the night after shot, legs were sore, loss of appetite and continuous cries of pain. By that weekend, still continuous screams of pain and rash broke out and "Mennen's" products starting burning her skin (she had used all their products from birth with no previous problems). When rash breaks out, her right eye seeps as if she has infection in it. Loss of appetite continued until oral steroid was given (Florida), still has problems with it when rash comes back. Since 11/20/00, sleep was affected and would only sleep for a hour at a time and continues to scream of pain (when being picked up or held at times). She had diarrhea from shot until last month (April). The rash will go into blister and skin will seep; glands swell. We've changed her formula for a month (Similac to Soy) with no change. Changed detergents from Tide to Dreft and there is no change. Rinse all clothing and bedding 3 times and no change. Watched for reaction to any food (did not eat "food" until age 5 months, 3 months after shot, not until oral steroids). No allergies. No treatments just lotions, ointments until last of ointment. Steroid creme (way too strong) and antihistamine. No soaps, limited bathing (every 3 days) just water and limited time. Fondak, limited time, Cetaphil soaps and lotion, every other day and no oils. Allergic reaction to treatment with cream and antibiotic (threw papers at me). All may work for a couple of days, then quit. Y Y 11/20/2000 11/20/2000 0 NONE PVT UNK Being treated for borderline RSV a week before shot NONE Unspecified reaction~Varicella (Varivax)~~0.00~In Patient 1
0170463 06/01/2001 PA 64.0 64 F 05/01/2001 Extreme tiredness, severe aching joints, shooting lightning-type pain in arms and legs, blurred vision, forgetfulness, swelling in legs and fingers. Hot sweaty feelings from the waist up. Hard to stand and still continuing Fiorinal and Fiorinal with codeine, Z-pack and Celebrex. The 60 day folow-up states the pt being very tired and weak; sweats; much pain in joints and muscles aches; severe pain in arms and legs-shooting pains especially at night. And additionally, cramps developed. The annual follow up received on 6/19/02 states instant memory loss, blurred vision, shooting pains in head, severe shooting pains in joints and muscles, hard to walk, numb crampy feelings in legs, cannot drive far, very tired and hot sweaty feelings, feet aches feel like swelling going to blow apart. Searching for other doctors. Y N 06/13/2000 06/15/2000 2 PVT OTH Zocor; Aspirin; Lotrel Heart By-Pass Surgery 1
0170464 06/01/2001 WI 60.0 59 F 05/24/2001 Joint pain in fingers, ankles and toes, post vax of 2nd Lymerix and continues to worsen. Y U 05/09/2000 06/01/2000 23 NONE PUB PVT Premarin; Prevacid NONE Acid Stomach; high cholesterol Joint pain~Lyme (LYMErix)~2~59.00~In Patient 1
0170465 06/01/2001 MI 0.6 0 .6 M 05/09/2001 On 4/23/01 the pt noticed a swollen area on right thigh the size of a nickel. No redness or drainage. Advised Mom to call private physician. The pt saw a physician on 5/9/01 and was placed on medication due to redness and swelling noted on both legs. Y Y 04/19/2001 04/23/2001 4 PUB OTH NONE NONE NONE MI2001038 1
0170466 06/01/2001 PA 2.0 2 .0 F 05/23/2001 3-4 hours, post vax, of Prevnar vaccine, the child spiked a fever to 103.5F which persisted for 3 days. She also developed a fine pinpoint red rash on her body. Y 05/11/2001 05/11/2001 0 NONE PVT PVT NONE NONE NONE Rash~Measles + Mumps + Rubella (no brand name)~1~1.00~In Patient 1
0170467 06/01/2001 MI 1.34 1 .3 F 05/18/2001 Patient received five vaccination 03/05/01. Starting 03/17/01 her hair started to fall out and in a period of 2 months she lost 50% of her hair. The back of her head is completely bald. Y N 03/05/2001 03/17/2001 12 PUB PUB 1
0170468 06/01/2001 CA 1.4 0 .3 M 06/13/2001 Rash on hands and feet. Afebrile. Y U 05/23/2000 05/29/2001 371 PUB UNK 1
0170469 06/01/2001 GA 1.25 1 .3 M 05/21/2001 The pt experienced redness at the site, swelling, warm to the touch, small red bumps around site. The pt developed hand, foot and mouth disease about 4th or 5th day post vax. Y 05/04/2001 05/05/2001 1 NONE MIL MIL NONE NONE NONE 1
0170470 06/01/2001 FL 1.75 2 .3 M 05/20/2001 7 days after vaccination he seized 6 to 8 times a day for 3 months. Y U 09/28/2000 10/04/2000 6 EEG PVT PVT NONE NONE NONE Rash,sorness~DTaP (no brand name)~~0.00~In Patient 1
0170471 06/01/2001 CA 0.3 0 .3 M 05/26/2001 Hives within 24 hours of vaccine administration. Y U 05/23/2001 05/23/2001 0 PVT PVT Atarax Eczema and Seborrhea 1
0170472 06/01/2001 CT 0.01 0 .1 M 05/16/2001 Baby received prevnar on 02/16/01; there was no adverse reaction noted. On 02/23/01 mother noted inter costal retractions. Work-up for cardiac, pulmonary and reflex negative N 02/06/2001 02/23/2001 17 EKG (-), Echo (-), UGI (-), PH Probe (-) PVT PVT NONE NONE NONE 1
0170473 06/01/2001 OR 2.0 2 .0 F 05/24/2001 Mother want to ED on 05/22/01 because of a 2cmx11/2 cm indurated site. The physican treated child for a cellulitis - child placed on keflex 05/24/01 - Follow-up visit with Primary care MD site slightly bigger - however PMD didnot feel that it was a cellulitis but continued on antibiotic. Attached report reviled chief complain: right leg redness and swelling. History of present illness: The patient is a 2-year-old female who was seen by her primary care physician yesterday for a well child check. She got her prevnar and hepatitis A vaccines at that visit. Her mother reports that she noticed the injection site to be a little bit swollen last night. When the patient's mother returned home from work to day at about 6:15 p.m. she noticed an area of redness and increased swelling around the injection site. She called her primary care physician and was told to draw a circle aroun the readness and to come to the Oregon Health Sciences University Emergency Department for evaluation. The patient's mother reports that in the last one to two hours since drawing the circle, the redness has continued to expand. The patient has had some upper respiratory infection systoms for the past three to four days including runny nose, mild cough, and sore throat. She was tested for streptococcal pharyngitis three or four days ago. That test was reportedly negative. she has not been febrile at home but did have a fever to 38 degrees here in the emergency department. She has had good appetite and normal energy today. she has been a little bit fussier than usual. She has had no rash or other symptoms noted. Y Y 05/21/2001 05/22/2001 1 NONE PVT PUB Rhinorrhea NONE 1
0170474 06/01/2001 GA 6.0 6 M 05/29/2001 2 days after vaccination a large area of erythema around 2 inches in diameter at injection site. Just posterior to this were 2 1 cm urticaril lesions. Very prurtic. Also with runny nose, cough, but not sure if related although it occurred within 22 hours of vaccination. Y 05/12/2001 05/23/2001 11 NONE PVT PVT Singular, vitamins NONE Vantin 1
0170475 06/01/2001 UT 0.2 0 .2 M 05/22/2001 Mom reported a seizure 2 days after vaccination. Called ER and saw Dr next day. Y Y 05/15/2001 05/17/2001 2 PUB PUB NONE UNK UT010307 1
0170476 06/01/2001 NH 1.0 1 .0 F 05/30/2001 On 5/25 pt developed hives on forehead, back, neck, and arms and legs. Pt also had diarrhea for 2 days. Fussy with Left leg redness around injection site. Y U 05/24/2001 05/25/2001 1 NONE PVT PUB NONE NONE NONE NH0116 1
0170477 06/01/2001 MA 44.0 43 F 05/02/2001 Sore shoulder pessisted many months after shot. Now getting PT for it. My physical therapist says I'm the 3rd person she's seen who has reported long term muscle soreness after this year's flu shot N 11/01/2000 MIL PUB NONE 1
0170478 06/01/2001 MI 15.0 15 M 05/01/2001 1 week after immunizations were given client began experiencing severe muscle pain in both arms. The pain was relieved with Motrin. The pain re-appeared 1 week later in both legs. The pain is so severe he had weakness in his legs. It later went to his back. The pain causes a writhing which last about 1 hour and comes and goes without predictability. Motrin/Tylenol make the pain tolerable. Client was seen by his DR twice. DR ordered lab tests on 5/3/2000. Telephone call to mom. Mom states the blood tests on patient were all negative. Patient continues to have intermittent back, arm, and leg pain which seems to be less painful than 2 weeks ago. He continues to take Motrin for pain relief. Y U 04/04/2001 04/11/2001 7 CBC, Sed Rate PUB OTH None NONE NONE MI2001037 1
0170479 06/01/2001 TN 47.0 M 05/14/2001 The pt experienced cold and flu symptoms. U 05/08/2001 NONE UNK UNK 1
0170480 06/01/2001 TN 43.0 M 05/14/2001 The pt experienced cold and flu symptoms. Pt treated with Azithromycin, Etodolac and Guaifenesin. U 04/01/2001 UNK UNK 1
0170481 06/01/2001 TN 54.0 54 M 05/14/2001 Pt developed signs/symptoms of cold/flu 1 day post vax. Pt also developed swollen feet and SOB. Others who received the Pneumococcal vax developed similar effects; however, the vaccines were supplied by 2 different drug manufacturers. Pt treated with po Promethazine & Guaifenesin/Dextromethorophan. 04/13/2001 04/14/2001 1 NONE UNK UNK hydralazine, furosemide, KCl SA, digoxin, spironolactone, felodipine, salsalate cardiomyopathy, MI x 2, CHF, HTN 1
0170482 06/01/2001 WI 4.0 4 M 05/25/2001 The pt experienced left arm redness, swelling, non-tender area which was slightly warm. Y 05/21/2001 05/23/2001 2 NONE PVT PVT NONE NONE NONE 1
0170483 06/01/2001 VI 11.0 11 M 05/22/2001 Approximately 15 minutes after receiving the 3rd dose of HBV, client returned to the Health Dept. with his mother. Cause of severe itching on back mother compared it to fleas. She said that it had lessened slightly since it started. No rash noted. Mother stated she gave him 2 doses of Benedryl 25mg. each. Y 05/16/2001 05/16/2001 0 NONE PUB OTH NONE NONE Asthma and skin allergies VA01012 1
0170484 06/01/2001 MI 27.0 27 F 05/03/2001 Client into clinic with c/o pain and swelling of left upper arm after receiving TD on 04/30/2001. RN unable to verify induration or erythema. client also with complaint of left cervical lymphadentopathy. Client stated she is concerned about the possibility of serum sickness. Convinced client to see PP on 05/17/2001 stated improved but soreness moved up to right . Has appt today with PP. Y Y 04/30/2001 04/30/2001 0 PUB PUB MI2001042 1
0170485 06/01/2001 MI 25.0 25 F 05/11/2001 Fever with in 3-4 hours after receiving IMOVAX; nausea; Rethergy, general aching; lack of appetite; shaking tremors started 24 hours later and continued for 4 days. Minor injection site redness, soreness and warmth at injection site. No hives, no edema, no sob, saw pcp on day 4. Benadryl on administred. improvement noted with in hours. Occasional sparadic jerking on day 5. day 6 returned to normal - no tremors. The follow up received on 6/25/01 stated, "client completed series of Rabies vaccine and Benadryl per oral prior to each dose. No adverse rreactions noted. 6/15/01, pt's current medical condition returned to normal." This case is closed. Y Y 05/04/2001 05/04/2001 0 PUB PUB NONE NONE NONE MI2001041 1
0170486 06/01/2001 MI 17.0 17 F 03/30/2001 On 3/27/01, pt c/o sore throat, brown circle around site where vax given 3/19. Pt denies swelling, redness, inflammation or fever. 3/28/01 left message on machine re: reactions to look for. Pt never returned calls 3/28 or 3/30/01. U 03/19/2001 03/27/2001 8 PUB PVT MI2001040 1
0170488 06/01/2001 CA 25.0 25 F 05/17/2001 Difficulty breathing 05/15/2001, went to ED-Not thought to be related to injection. On 05/04/2001 had fever and vomiting. Had lesion 2 cm and worsened on 5/15 to size it is now. Reaction on right arm at injection site with 7 cm large swollen, red area. Y U 05/04/2001 05/05/2001 1 NONE PVT PVT Alupent NONE Asthma 1
0170489 06/01/2001 IA 31.0 31 F 05/25/2001 Noticed swelling Tues 5/22. Received shot 5/17. Pain extends down to elbow and up toward back shoulder and neck area. Aches feel like flu aches. Swelling is in muscle and it looks like I have a bigger muscle. Y N 05/17/2001 05/22/2001 5 PUB OTH NONE Allergies to animals/ plants/ molds 1
0170490 06/01/2001 CA 40.0 40 F 05/09/2001 At approx 6:30 pm - decreased back pain when to muscle spasms in hands/ feet, joint pain, chills with teeth chattering. Temp increased 102s. On 05/09/01 - Temp decreased 101 degrees with tylenol and discomfort. Y 05/08/2001 05/08/2001 0 UNK PUB PVT UNK NONE NONE 1
0170491 06/01/2001 TX 2.0 2 .7 M 05/02/2001 Redness to right arm, warm to touch, mild swelling, denies pain. Received treatment, antibiotic for 5 days. Arm is better. Y Y 04/26/2001 04/27/2001 1 PUB PUB None NONE NONE 1
0170492 06/01/2001 NY 4.5 4 F 05/18/2001 On 05/17/2001 during pre k school day child complained of some soreness to right arm to teacher. On 05/18/2001 child complained of more severe discomfort in right deltoid area. It was red and warm to touch. His temp was 100.4 at school nurse's office. Sent home with parent with instructions for comfort and care. Primary MD advised of local reaction to DTAP this dose. U 05/16/2001 PUB PUB None NONE 1
0170493 06/01/2001 OR 0.5 0 .4 M 05/18/2001 Inconsolable crying for a half day with rash and temp of 102 F. Y 02/20/2001 02/21/2001 1 NONE PUB PUB URI 1
0170494 06/01/2001 VA 18.0 F 05/17/2001 Fatigue, headache, stomach ache, diarrhea on 05/11/01 and 05/12/01 subsiding on 05/13/01. Arm was sore at injection site, but primary complaint was as above. Y 05/11/2001 NONE PUB PUB NONE Pt may have had and adverse reaction to pertussis as a child. Records unavailable. Received 1/2 dose due to uncontrollable crying. 1
0170495 06/01/2001 FL 3.3 3 U Arthritic type reaction with confluent red on anterior 3rd left finger, down into distal above the knee. Child still with active play; no systemic signs and symptoms. Given steroid and Zrytec-resolved on 24-36 hrs. Seen recheck 05 05/11/001. Y Y 05/08/2001 05/08/2001 0 NONE PUB PVT NONE NONE 1
0170496 06/01/2001 MA 4.0 4 M 05/21/2001 NO DATA ENTERED. Y 05/18/2001 05/19/2001 1 PVT PUB NONE NONE 1
0170497 06/01/2001 NY 40.0 40 F 05/29/2001 The patient states her "arm very swollen the whole upper part, very warm to touch, and a little red". She applied ice and took Ibuprofen with relief. The arm was swollen the next evening when ice was not used. The swelling lasted until Monday, 05/21/01. At the present 05/24/01, the patient has only itching at the site. Y 05/17/2001 05/25/2001 8 OTH UNK NONE NONE NONE 1
0170498 06/01/2001 UT 1.08 1 .1 M 05/16/2001 Around 9 hours after immunizations, this infants parent noticed a fever that continued to increase to 105 F. The patient began vomiting and having tremors and possible convulsions. At 9:00 PM, the patient was taken to the ER, he had IV's started and was treated with antibiotics. He was released after 3 hours. Y Y 03/21/2000 03/21/2000 0 Labs in the ER- no result. PUB PUB NONE NONE NONE UT012706 1
0170726 06/01/2001 NY 1.2 1 .2 F 05/30/2001 Information has been received from a nurse practitioner concerning a 14 month old female patient who on 04/29/97 was vaccinated with a 1st dose of MMR vaccine live. Soon after administration, the patient became lethargic and developed a high fever. She was taken to the ER where it was reported that the patient "had a possible febrile seizure." The child subsequently recovered from her experience. The possible febrile seizure was considered a significant medical event. No further information is available. Y Y 04/29/1997 04/29/1997 0 UNK UNK UNK UNK WAES00040570 1
0170727 06/01/2001 6.0 F 05/30/2001 Information has been received from a physician concerning a 6 year old female relative who was vaccinated with one dose of Measles virus live. The reporting physician noted that he was not sure if the patient received MMR or measles virus vaccine live. Subsequently, the patient developed diabetes post-vaccination. The patient sought unspecified medical treatment. Additional information has been requested. Y U OTH OTH UNK WAES00040674 1
0170728 06/01/2001 IL 1.9 2 .1 F 05/30/2001 Information has been received from a lawyer concerning an approximately 11 year old female patient who on 03/29/90 was vaccinated with one dose of MMR live. In approximately 2000 the patient was diagnosed with subacute sclerosing panencephalitis and was hospitalized. No further information is available. Y Y U 03/29/1990 OTH OTH UNK UNK WAES00040749 1
0170729 06/01/2001 GA 1.2 1 .2 F 05/30/2001 Information has been received from a healthcare professional concerning a 14 month old female patient with no known allergies and no past medical history who on 04/04/00 was vaccinated SC in the left arm with a 1st dose of Measles virus live. Concomitant therapy included Hib conjugate vaccine (HibTiter). On 04/18/00, the patient experienced a fever of 103.8 F and had a seizure that lasted for 5-10 minutes. The patient's seizure is considered to be an Other Medical Event. The patient was seen in the ER and treated with Tylenol and Motrin for the fever. It was noted that urine and blood cultures were Neg. On 04/19/00 the patient's fever was 101 to 102 F. The patient did not have a rash. Follow-up information from a physician reported that the patient experienced a febrile seizure. ON 04/19/00, the patient recovered from her experience. Additionally, on 04/19/00 the patient was diagnosed with a right ear infection. Y U 04/04/2000 04/18/2000 14 04/04/00 Blood culture - Neg. 04/18/00 Temperature measurement 103.8. 04/04/00 Urine culture - Neg. PVT PVT NONE WAES00042121 1
0170730 06/01/2001 TX U 05/30/2001 Information has been received from a company representative concerning a child who was vaccinated "a few years ago" with one dose of MMR live. Subsequently, the patient developed encephalitis "which the mother connected to the vaccine." The patient sought unspecified medical treatment. Upon medical review, the patient's experience was considered an "other medical event". Follow-up information received from a physician indicated that the patient had a "possible reaction to DTP" and that the mother did not want any other vaccines given to her other child. No further information is expected. Y U OTH OTH UNK WAES00052133 1
0170731 06/01/2001 CA 1.25 1 .3 F 05/30/2001 Information has been received from an RN concerning a 15 month old Asian female with no known allergies and a history of otitis media who on 6/29/00 was vaccinated with a 1st dose of MMR in the left buttocks (lot 633095/0254K). Concomitant therapy included the 2nd dose, in the right buttock, of Act-Hib (lot UA509AA). It was reported that there were no illnesses at the time of vaccination. On 6/30/00, the pt developed a fever that had elevated as high as 103F. On 7/1/00, the pt vomited 1 time and on 7/3/00 had diarrhea 1 time. It was reported that her appetite had been diminished but that she had been taking fluids well. Additionally, she was less active than usual. She also had a cough and runny nose. On 7/3/00, the pt was seen in the ER. At the time of the visit, her temperature was 103F (rectum). Her vital signs were stable. The physical and neurological exams were benign except for the following: the left tympanic membrane was red, dull and bulging, but still transparent. The right tympanic membrane was normal except for a slight tinge of red. Her pharynx was diffusely erythematous. There was questionable exudate on the right tonsil. The physician's dx was acute febrile illness, acute pharyngitis and acute left otitis media. The pt was started on amoxicillin and advised to follow-up with her PCP on 7/4/00. Upon internal review, the pt's fever was determined to be an "Other Medical Event". The pt was discharged from the ER in stable condition on 7/3/00. On 7/10/00, the pt developed a rash and on 7/12/00, the pt experienced a fever of 104.6F. The pt's mother gave her Tylenol and lukewarm baths. She was seen in the physician's office on 7/12/00, at which time she was alert. It was noted that she had still been taking the amoxicillin prescribed in the ER for bilateral otitis media. The physician suspected a possible viral infection and she was started on Cedax 9mg po qd for 10 days. On 7/13/00, the physician's office was notified by the pt's mother that the rash had increased and that the fever persisted at 105F. The physician's impression following the phone call was a possible viral fever and amoxicillin rash. On 7/14/00, the pt's fever was "still off/on". The rash was noted to be "morbilliform" and all over her body. Her tympanic membranes were less red. There were no Koplik's spots. The physician's impression was a possible measles rash due to the MMRII. Two additional pts (WAES 00071118 & 00071119) had a similar experience. The reporter expressed concern with the lot number. Follow-up information from an RN reported that on 7/21/00, the pt was seen by a physician and noted to be "feeling better". The pt was finished her medications as per the reporter. The pt is recovered. No further information is available. Y Y 06/29/2000 06/30/2000 1 Pulse Ox on 7/3/00-98% on room air-nml; Temperature on 6/30/00-103F; on 7/3/00-103F (rectum); on 7/13/00-105F; on 7/12/00-104.6F PVT PVT Otitis media WAES00071009 1
0170732 06/01/2001 NH 1.4 1 .4 M 05/30/2001 Information has been received from a registered nurse concerning a 16 month old Caucasian male patient with seizure disorder and a history of anoxic encephalopathy and who was on a ketogenic diet since 04/15/00 who on 09/11/00 was vaccinated with a 1st dose of MMR live SC in the right thigh. The following day, the patient experienced seizures (considered to be disabling) and the patient's laboratory values included "moderate ketones" (usually in the "large range"). It was noted that the patient's dietician stated that "1 mg of sugar compound is enough to throw ketosis out of kilter." As of 09/14/00, the patient was "doing okay". The patient also developed a raised redness at the injection site "2 1/4 inch in diameter." Unspecified medical attention was sought. Follow-up information from registered nurse indicated that the patient's "ketones went from large to low to moderate to almost small. Hence, seizures began". Subsequently, the patient recovered. Y Y Y 09/11/2000 09/12/2000 1 Serum acetone on 9/12/00-moderate; Diagnostic lab 9/00-ketones went from large to low to moderate to almost small. UNK UNK UNK Dietary control; Seizure disorder Anoxic brain damage, dietary control, seizure disorder. WAES00091171 1
0170733 06/01/2001 PA 1.0 1 .0 M 05/30/2001 Information has been received from a physician concerning a 12 month old male who on 8/31/00 was vaccinated SC with the 1st dose of MMRII (lot 63593/0978K). On 9/7/00, the pt developed a "low grade fever". On 9/8/00, the pt's fever was 102F and he experienced a seizure. Later that same day, he was seen be a physician. On 9/9/00, the pt experienced 4 additional seizures and was taken to the ER. Upon internal review, seizure was considered to be an "Important Medical Event". The pt recovered from the event as of 9/11/00. No further information is available. Y Y 08/31/2000 09/07/2000 7 UNK UNK UNK UNK WAES00100660 1
0170734 06/01/2001 F 05/30/2001 Information has been received from a lawyer/physician concerning a female child who was vaccinated with MMRII and within 24 hours, post vax, the pt had "seizure activity with significant impairment". Upon internal review, "seizure activity" was considered to be an "Other Medical Event". No further information is available. N OTH OTH UNK UNK WAES00101100 1
0170735 06/01/2001 NY 1.25 1 .3 M 05/30/2001 Information has been received from an RN concerning a 15 month old Caucasian male who on 10/9/00 was vaccinated with a 1st dose of MMRII (lot 630633/0102K) in the left leg. On approx. 10/11/00, the pt experienced redness and induration 4" X 4" and hot to the touch, at the injection site. On 10/13/00, the pt experienced fever. Temperature by ear was 105F. Upon internal review, fever was considered "Other Medical Event". On approx. 10/16/00, the pt developed a rash. Pt received Tylenol and Advil for fever and oatmeal baths for rash. In follow-up, the RN reported that the injection site was swollen and that ice was applied to the site. It was indicated by 9/16/00, the pt recovered. No further information is available. Y 10/09/2000 10/11/2000 2 Temperature on 10/13/00-105F PVT PVT UNK UNK WAES00101533 1
0170736 06/01/2001 IL 1.0 M 05/30/2001 Information has been received from a physician concerning a 1 year old male who on approx. 11/15/00, was vaccinated with MMRI. On 11/20/00, the child had "a seizure-like event". Unspecified medical attention was sought. Upon internal review, a seizure-like event was determined to be an "Other Medical Event". Additional information has been requested. Y U 11/15/2000 11/20/2000 5 UNK UNK UNK UNK WAES00111878 1
0170737 06/01/2001 MS U 05/30/2001 Information has been received concerning a pt who was vaccinated with MMRII. Concomitant therapy included streptococcus pneumonia vaccine (PREVNAR) administered IM. Subsequently, the pt experienced a febrile convulsion. The febrile convulsion was considered a "Significant Medical Event". Follow-up was received which indicated "event did not occur". This information was originally received from an RN. No further information is available. U OTH OTH UNK WAES00122048 1
0170738 06/01/2001 AZ M 05/30/2001 Information has been received from a consumer concerning her brother who received 1 dose of MMRII. The pt experienced a seizure after receiving the vaccination. Upon internal review seizure was determined to be an "Other Important Medical Event". The consumer also reported her daughter's experience following vaccination with MMRII (WAES 01021270). Additional information has been requested. U OTH OTH UNK UNK WAES01021357 1
0170739 06/01/2001 FL 34.0 34 F 05/30/2001 Information has been received from a physician concerning a 34 year old female with no known drug allergies and a history of rheumatoid arthritis who on approx. 2/5/01 was vaccinated with MMRII. On 2/19/01, the pt was hospitalized to be treated for Guillain-Barre Syndrome. The physician had no further information. Additional information has been requested. Y Y U 02/05/2001 02/19/2001 14 OTH OTH UNK Rheumatoid arthritis WAES01021730 1
0170740 06/01/2001 NY 4.0 4 M 05/30/2001 On 03/16/01, within 5-10 minutes of receiving the MMR, the child developed hives and a raised maculopapular rash on his face, legs, and spread all over his body. It was reported that the patient was immediately treated with epinephrine shot and was "reported as fine 20 minutes after the epinephrine". The child was given oral diphenhydramine for the weekend. On the date of the report, 03/19/01, the child was "seen in the clinic this morning and rash, itching, all gone". The report indicated that the first dose of MMR vaccine live was given at an unknown place and that it is unknown if the child had a reaction. Upon internal review, the patient's experience was determined to be other medical event. Additional information is not expected. Y Y 03/16/2001 03/16/2001 0 OTH OTH NONE WAES01032329 1
0170741 06/01/2001 PA 2.6 2 .6 F 05/15/2001 Information has been received from a healthcare professional concerning her 31 month old Caucasian / Hispanic daughter with an amoxicillin allergy (hives - February 1999) who on 07/29/98 was vaccinated with a 1st dose of Varicella virus vaccine live SC in the left arm. There was no post-vaccination rash. On 02/24/00, the patient was inadvertantly vaccinated with a 2nd dose of Varicella virus vaccine live that had expired on 02/20/00. On the morning of 02/29/00 the patient had 50+ pox with a fever of 101 F and a runny nose. In the evening that same day the child had 100+ pox and a temperature of 100 F. On the morning of 03/02/00, the child had 300+ pox and no temperature. By later that evening her pox had decreased to less than 150. By 03/04/00 all of the child's pox had crusted over. It was noted that the patient breast-fed until mid May 1998, during which time her mother had varicella. The reporter felt that the patient's experience was an Important Medical Event. No further information is available. Y Y 02/24/2000 02/29/2000 5 PVT UNK UNK varicella exposure; amoxicillin allergy WAES00022488 1
0170742 06/01/2001 VA 24.0 23 F 05/15/2001 Information has been received from a consumer, a 24 year old Caucasian female patient who on 04/01/99 was vaccinated with one dose of Varicella virus vaccine live. On 04/10/99, the patient learned that she was pregnant. On 12/16/99, at 37 weeks gestation, the patient delivered a baby boy. The infant was placed in the NICU because he had a slight amount of fluid on his lungs. The infant was treated with antibiotics and was discharged from the hospital after 3 days. "He was fine after that". Additional information has been requested. This report is part of the pregnancy registry. Y Y 04/01/1999 12/16/1999 259 OTH OTH UNK Pregnancy (LMP = UNK). WAES00040623 1
0170743 06/01/2001 UT 7.0 7 M 05/15/2001 Information has been received from a physician's office concerning a 7 year old male patient who on 01/11/00 was vaccinated with a 1st dose of Varicella virus vaccine live SC in the right arm. Subsequently, the patient developed "multiple lesions, some became red with green pus." The patient was placed on amoxicillin trihydrate (+) clavulanate potassium (Augmentin) chewable tablets for 10 days. Two weeks post-onset, the patient recovered from multiple skin lesions. The reporter felt that the patient experienced an Other Important Medical Event. Additional information has been requested. Y Y 01/11/2000 OTH OTH UNK UNK WAES00040943 1
0170744 06/01/2001 CA 16.0 16 F 05/15/2001 Information has been received from a 16 year old white female consumer who was vaccinated with a 1st and 2nd dose of Varicella virus vaccine live SC in the left arm on 03/10/00 and 04/07/00, respectively. On 04/10/00,the patient was "broken out with spots, and diagnosed with chickenpox. On 04/11/00, the patient was seen by a physician again and re-diagnosed with an allergic reaction to the vaccine. The patient's pox looked more like welts, there were swollen red areas on her hips, knees, feet, hands, and arms. It was very painful for her to walk, and her head itched. The patient was very uncomfortable until 04/13/00 evening and on the morning of 04/14/00, she was 99% better." Follow-up information from a physician indicated that on 04/10/00, the patient developed a rash described as "red, papular, few with central vesicle on the chest, back, lower extremity, some hive-like." At the same time of the 2nd dose of Varicella virus vaccine live, the patient had been treating a wart on her left thumb and subsequently developed cellulitis. The patient did not have a fever. The patient was diagnosed with "atypical varicella vs. allergic reaction" and was given ceftriaxone sodium (Rocephin) and diphenhydramine HCL (Benadryl) PO. The patient was seen by a physician again on 04/11/00 complaining of pain with movement. The patient's cellulitis was "better; the other rash was more flat on left extremity, feet, and back." The patient was given amoxicillin trihydrate (+) clavulanate potassium (Augmentin) and loratadine (Claritin). On 04/13/00, a telephone follow-up indicted that the rash was gone but the patient's feet were still painful. On 04/18/00, the patient had recovered. The patient's experience was considered to be other medical events. Y Y 04/07/2000 04/10/2000 3 PVT PVT UNK Welts WAES00041729 1
0170746 06/01/2001 MI 2.0 2 .0 F 05/15/2001 Information has been received from a registered nurse concerning a 6 year old female patient who on 11/08/95 was vaccinated with one dose of Varicella virus vaccine live. There was no concomitant therapy. On 03/31/00, the patient presented to a physician's office with varicella lesions all over her body. The patient's experience was considered to be disabling by the reporter. No prescription drug treatment was required for the experience. Follow-up information from a registered nurse reported that all of the patient's lesions were scabbed over and no other problems were noted. Another patient (WAES #00061355) had a similar experience. Y Y Y 11/08/1995 03/31/2000 1605 UNK UNK NONE UNK WAES00051811 1
0170747 06/01/2001 NY 4.0 4 F 05/30/2001 Information has been received from a physician concerning a 4-year-old female patient who on 28-Mar-2000 was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation). It was noted that there were no concurrent medication, significant past medical history or known allergies. On 01-APR-2000 the patient experienced a macular, popular rash all over her body. The patient was afebrile. Additionally, it Y N 03/28/2000 04/01/2000 4 OTH OTH NONE NONE WAES00040422 1
0170748 06/01/2001 TX 44.0 44 F 05/30/2001 A 44 yr old Caucasian female with a pollen allergy, hay fever, asthma,and environmental allergies who on 30-MAR-2000 was vaccinated with second dose of measles virus vaccine live and mumps vaccine rubella virus vaccine live (second generation) SC in the left arm. Other therapy included Fumotidine, induration and dose and indication unknown (MSD). Also given was Tylenol and Allegra. On 31-MAR-2000 experienced itching. On 03-APR-2000 the pt experienced a rash on the face and neck. The rash progressed to the trunk and limbs on 06-APR-2000. The pt also experienced pharyngitis. It was reported the Allegra did not help with itching. The pt was taken to the emergency room and a strep culture performed on 06-APR-2000 was negative. The pt recovered on 11-APR-2000. Y Y 03/30/2000 03/31/2000 1 throat culture performed on 04/04/2000 was negative. PUB OTH Tylenol, Pepcid, Allegra allergy, asthma, hay fever, pollen allergy WAES00040561 1
0170749 06/01/2001 M 05/30/2001 Information has been received from a RN concerning a male pt who on 29-MAR-2000 was vaccinated with measles virus vaccine live and mumps virus vaccine live and rubella virus vaccine live (second generation) SC. On 09-APR-2000, the pt developed a fever of 105F and was diagnosed with acute febrile illness. The pt was doing better per the RN. The reporter had a concern about the lot of vaccine administered (17333) because of two adverse experiences were reported and the office used 200 doses. Follow up info from a RN indicated that the office have had no other problems other than the two adverse experiences she reported previously . It was reported that the pt recovered. Y Y 03/29/2000 04/09/2000 11 Temperature measurement on 04/09/2000 was 105F OTH OTH UNK UNK WAES00040817 1
0170751 06/01/2001 MI 1.0 U 05/30/2001 Info has been received from a Dr concerning a 1 yr old pt who was vaccinated with measles virus vaccine live and mumps virus vaccine live and rubella virus vaccine live (second generation) The pt also received varicella virus vaccine (MSD). Subsequently the pt developed localized redness at both injection sites. The pt pulled away during vaccination with varicella virus vaccine and received only half the dose. The pt was treated with Benadryl and the pt recovered. Y OTH OTH UNK WAES00041164 1
0170752 06/01/2001 OH 4.0 4 M 05/30/2001 Information received from a registered nurse concerning a 4 yr old Caucasian male pt who on 11-APR-2000 was vaccinated in the right arm with a second dose of measles virus vaccine live and mumps virus vaccine live and rubella virus vaccine live (second generation) (lot #0381D). There were no noted illnesses at the time of vaccination. There are no known allergies or past medical history. Gentamycin eye drops were noted as therapy for the pt; however indication and therapy dates were not specified. On 12-APR-2000 the pt developed a large reddened nodule on the right upper arm. The pt was seen in the Dr's office on 13-APR-2000 at which time there was a 3/4 inch hardened knot at the injection site with slight erythema. Y U 04/11/2000 04/12/2000 1 PUB OTH Gentamycin WAES00041399 1
0170753 06/01/2001 NY U 05/30/2001 Information has been received from a Dr concerning two pts who were vaccinated with measles virus vaccine live and mumps virus vaccine live and rubella virus vaccine live (second generation). The pts experienced roseola like rash. The roseola rash improved after two days. Seven days after vaccination, the pts experienced a fever of 101 degrees F. It was also noted the vaccine was improperly stored for 12 hours due to a power outage. Medical attention was sought. No further info is available. Y U OTH OTH UNK UNK WAES00041426 1
0170754 06/01/2001 NJ 18.0 18 M 05/30/2001 Information has been received from a consumer concerning his 17 yr old son with no known allergies who on 20-MAR-2000 was vaccinated with one dose of measles virus vaccine live and mumps virus vaccine live and rubella virus vaccine live (second generation). It was reported that since the time of vaccination, the pt was sick with a sore throat and fever. Unspecified medical attention was sought. Additionally, it was noted that on 15-APR-2000 the pt broke out what a Dr termed a viral rash. The pt was on antibiotic and antihistamine therapy; however, it was not clarified if they were concomitant therapies or treatment medications. Additional info has been requested. Y N 03/20/2000 03/20/2000 0 OTH OTH UNK UNK WAES00041510 1
0170755 06/01/2001 F 05/30/2001 Information has been received from a RN concerning a female pt who was vaccinated with measles virus vaccine live and mumps virus vaccine live and rubella virus vaccine live (second generation), when in school. It was reported that the pt was trying to get pregnant and is going through infertility treatments. The pt sought unspecified medical treatment and was found to have a negative rubella titer. Additional info has been requested. Y U diagnostic laboratory result is negative rubella titer OTH OTH UNK UNK WAES00041787 1
0170756 06/01/2001 PA 1.0 M 05/30/2001 Information has been received for a Dr concerning an approximately 12 month old male who was vaccinated with measles virus vaccine live and mumps virus vaccine live and rubella virus vaccine live (second generation). Concomitant vaccinations included varicella vaccine live (MSD). Three to 4 weeks ago post vaccination, the pt began to lose his hair. The hair loss progressed to total alopecia within 4 weeks. The pt sought unspecified medical attention. Additional info has been requested. Y U OTH OTH UNK WAES00042089 1
0170757 06/01/2001 NJ 4.0 4 M 06/30/2001 Information has been received from a physician concerning a 4 yr old male pt who on 30-MAR-2000 was vaccinated with a dose of measles virus vaccine live and mumps virus vaccine live and rubella virus vaccine live (second generation) (lot # 1714J). Concomitant vaccinations that same day included poliovirus vaccine (IPOL) (lot #P1231) and aluminum potassium sulfate and diphtheria toxoid and pertussis vaccine and tetanus toxoid (Tripedia) (lot #00161CA). On 30-MAR-2000, the pt also had a Mantoux test (Tuber Sol) 5 TU in the forearm. The day following vaccination, the pt was not feeling himself and developed a red mark around the area of the shot. On an unspecified date the pt recovered. No further information is available. Y 03/30/2000 03/31/2000 1 Mantoux test done on 03/30/2000 PVT PVT UNK WAES00042186 1
0170758 06/01/2001 PA 1.4 1 .4 F 05/30/2001 Information has been received from a Merck employee concerning a 17 month old female who on approximately 04-APR-2000 was vaccinated with measles virus vaccine live and mumps virus vaccine and rubella virus vaccine live (second generation). On 17-APR-2000 the pt experienced screaming. She did not want to be picked up, put down. Nothing seemed to make her stop crying. It was noted that in the past, in the morning when the mother would get the baby out of bed, she was a very bubbly, happy child. Now, she put her lead down and started to cry. The parents had her checked for a cold, sore throat, ear infection, with nothing found The mother thought she was doing this for attention. There was no adverse events at the time of vaccination. U 04/04/2000 04/17/2000 13 OTH OTH UNK UNK WAES00042351 1
0170759 06/01/2001 OH U 05/30/2001 Musculoskeletal stiffness: fever Information has been received from a requistered nurse concerning a patient who was vaccinated "years ago" with one dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation). Two weeks post-vaccination, the patient experienced muscular stiffness and developed a fever. The patient sought unspecified medical attention. Additional information has been requested. Y U OTH OTH UNK UNK WAES00042387 1
0170760 06/01/2001 U 05/30/2001 Rash - Information has been received from a registered pharmachist concerning a patient who was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) or measles virus vaccine. Ten days later, the patient experienced a rash. U OTH OTH WAES00042392 1
0170761 06/01/2001 CA U 05/30/2001 Information has been received from a registered nurse concerning a patient who was vaccinated with measles virus vaccine live (-) mumps virus vaccine live (+) rubella virus vaccine live (second generation). Subsequently the patient experienced an unknown event. U OTH OTH UNK UNK WAES00042817 1
0170762 06/01/2001 IL 1.0 1 .0 M 05/30/2001 Information has been received from a physician concerning a 12-month-old caucasian male patient with no known pre-existing allergies or medical conditions who on 20-SEP-1999 was vaccinated with a first dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation)(lot # 616452/0386D) IM in the left arm. On 23-SEP-1996, the patient developed a fever up to 105f. The patient sought unspecified medical attention. Follow-up information from a physician indicated that on 30-SEP-1996, the patient recovered. Y Y 09/20/1996 09/23/1996 3 PVT PVT WAES00050072 1
0170763 06/01/2001 PA 1.08 1 .1 M 05/30/2001 Information has been received from a registered nurse concerning a 13-month-old caucasian male patient who on 10-JAN-2000 was vaccinated with a first dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) (lot N633012/12763) IM in the thigh. On 18-JAN-2000, the patient developed a serious measles rash, a fever and was sleeping poorly, moody, and tugging at his ears.: The patient sought unspecified medical follow up information from a registered nurse indicated that subsequently, the patient recovered. Y Y 01/10/2000 01/18/2000 8 PVT PVT UNK UNK WAES00050189 1
0170764 06/01/2001 1.0 M 05/30/2001 Fever, Anorexia, insomnia, sweat gland disorder, diarrhea, - Information has been received from a consumer concerning her 12 month old son who on 12-APR-2000 was vaccinated with the first dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation). On 24-APR-2000 the patient developed fever, diarrhea, torso rash (boat like rash). Inability to sleep, and anorexia. The reporter stated that by 28-Apr-2000, Friday night, "most of those sysptoms have disappeared... Though he still isn't himself.."The patient sought medical attention from the family physician. Y N 04/12/2000 04/24/2000 12 OTH OTH UNK UNK WAES00050265 1
0170765 06/01/2001 TX 5.0 5 F 05/30/2001 Injection Site Swelling, Injection site erythema, Injection site pain, Injection site warmth - Information has been received from a nurse practitioner concerning a 5-year-old hispanic female patient with a history of measles monovalent vaccination in Mexico who on 01-May-2000 was vaccinated with a first dose of measles virus vaccine live (+) mumps virus vaccine live (+) reubella virus vaccine live (second generation ) lot #630631/05453) sc in the left deltoid. Concomitant vaccinations that same day included a first dose of hepatitis B vaccine incombinant (yeast) (MSD) (lot #634144/17413) IM in the right deltoid, a first dose of varicella virus vaccine live (MDS) (lot #633304/07273) SC in the right arm and a fifth dose of diphthoria toxoid (+) pertussis vaccine (+) tetanus toxoid (lot number: 0006r) Im in the left deltoid. On 03-MAY-2000, the patient experienced a swollen, red, warm, tender area 2.5 inches in diameter near injection site of the left deltoid. The patient was afebrille. The patient sought unsepifed medical attention. Follow-up information from a nurse practitioner indicated that the reacton occurred at the site of the measles virus vaccine live (-) mumps virus vaccine live (+) rubella virus vaccine live (second generation) injection. The affected area was approximately the size of a baseball and there was no fever or other systemic signs. Additional information has been requested. Y U 05/01/2000 05/03/2000 2 UNK UNK Medical history: vaccination WAES00050615 1
0170766 06/01/2001 NY 5.0 F 05/30/2001 Rash Information has been received from a registered nurse concerning a 5 year old female who on approximately 06-APR-2000 was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation). subsequently, the patient experienced a generalized rash. Medical attention was sought. Y U 04/06/2000 OTH OTH UNK UNK WAES00051273 1
0170767 06/01/2001 NE 1.25 1 .3 F 05/30/2001 Eryhema Multiforme Minor - Information has been received from a physician concerning a 15 month old caucasian female with sinusitus and otitis media at the time of vaccination who on 05-May-2000 was vaccinated with a second dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) SC in the right lower thigh. On 07-May-2000 the patient began a ten day course of amoxicillin trihydrate, On 15-May-2000 the patient experienced an erythematous rash consistant with erythema multiform. She also experienced a fever. she was seen in the clinic on 16-May-2000 and 17-May-2000 and was started on cetirizine dihydrochloride (Zyrtec). diphenhyramine HCL (Benadryl). and reassura. subsequently, the patient recovered. No further information is available. Y 05/05/2000 05/15/2000 10 UNK UNK Amoxil otitis medial sinusitis Unk WAES00051728 1
0170768 06/01/2001 ID U 05/30/2001 Rash - Information has been received from an employee of the Idaho Immunization Program who was informed by a nurse that a child was vaccinated with measle virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) on approximately 15-May-2000. Subsequently, on approximately 15-May-2000 the patient experienced a "full-body rash". Unspecified medical attention was sought. Additional information has been requested. Y N 05/15/2000 05/15/2000 0 UNK OTH UNK UNK WAES00051880 1
0170769 06/01/2001 NY 30.0 M 05/30/2001 Parotitis - Information has been received from a physician concerning a 30 year old male physician who was vaccinated with one dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation). Subsequently, the patient developed parotitiis. The patient sought unspecified medical attention. Additional information has been requested. Y U OTH OTH UNK UNK WAES00052141 1
0170770 06/01/2001 MO 5.0 M 05/30/2001 Injection site swelling, injection site erythema- Information has been received from a health care professional concerning a 5 year old male patient with cystic fibrosis who on 03-May-2000 was vaccinated SC in the right arm with a second dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) (lot #634038/1713J). Concomitant therapy on 03-May-2000 included a fourth dose SC in the left arm of poliovirus vaccine (IPOL) and a fifth dose IM in the left arm of aluminum potassium sulfate (+) diphtheris toxoid (+) pertussis vaccine (+) tetanus toxoid (tripedia). Other concomitant therapy included vitamine A.D.E.K. albuterol and bedesonide (Nasocort)> It was noted that the patient had an upper respiratory infection at the time of vaccination but that he was afebrile. On 04-May-2000 the patient experienced swelling and redness to the upper arm where the injection was administered. It was reported that the patient recovered from his experience. Y 05/03/2000 05/04/2000 1 PVT PVT ALBUTEROL NASOCORT Vitamin a Vitamin d Vitamin e Vitamin k Upper respiratory infection concurrent condition: cystic fibrosis WAES00052487 1
0170772 06/01/2001 OH 1.25 1 .2 M 05/30/2001 Information has been received from a physician concerning a 15-month-old caucasian male patient with and upper respiratory infection and bilateral otitis media and hydrocele, hypoplasia of left thumb, right inguinal hernia, and develomental delay who on 25-May-2000 was vaccinated with a first dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) (lot 632400/10820) in the left thigh. Concomitant vaccinations that same day included a first dose of varicella virus vaccine live (MSD) (lot 632616/1688J) in the right thigh, a fourth dose of heamophilus B conjugate vaccine in the left lateral thigh, and a fourth dose of diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid in the right lateral thigh. On 03-June-2000, the patient experienced a generalized rash. the patient was seen by a physician who saw no evidence of a rash and the patient was afebrile. Follow-up information from a physician indicated that the patient's generalized rash was described as "faintly erythematous, macular blanching rash with no petechiae. Most lesions had a pale halo. There was no induration, swelling, or vesiculation and it was nonpruritic. The duration of the rash was 1 week. there was no treatment expect observation and diphenhydramino HCL (Benadryl)." No further information is available. Y Y 05/25/2000 06/03/2000 9 PVT PVT otitis media: upper respiratory infection concurrent conditions; developmental delay; hypoplasia, inguinal hernia, testicular hydrocele WAES00060676 1
0170773 06/01/2001 IA U 05/30/2001 Parotitis; Information has been received from a registered nurse concerning a child who on 09-Jun-2000 was vaccinated with the second dose of measles virus vaccine live (+) mumps virus vaccine ive (+) rubella virus vaccine live (second generation). On 13-Jun-2000 the patient developed parotiditis. The patient sought unspecified medical attention. Additional information has been requested. Y U 05/09/2000 05/13/2000 4 OTH OTH UNK UNK WAES00061428 1
0170774 06/01/2001 WA 25.0 25 F 05/30/2001 Headache, Malaise, rash, Pharyngitis, Information has been received from a health care professional concerning a 25 year old Hispanic female patient with no known medical history or allergies who on 8 Jun 2000. In the morning, was vaccinated in the right upper arm with a second dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) (lot #633016/12803). Concominant vaccinations that same they were a second dose of hepatitis b vaccine recombinant (yeast) (MSD lot # 630591/17353) given vie the left deltoid. On 12 Jun 2000 the patient developed a diffuse red rash associated with headache, slight general malaise and sore throat. The rash on her arms, trunk, and thighs was approximately 20 pustules which were were separate raised and red fluid filled. These pustules were tender and painful, no itching was noted and they lasted approximately 4 days. Medical attention was sought. Subsequently the patient has recovered. No further information is expected. Y Y 06/08/2000 06/12/2000 4 PVT PVT NONE WAES00061446 1
0170775 06/01/2001 PA 10.0 M 05/30/2001 Rash - Information has been received from a registered pharmacist concerning a 10 year old male patient, who was vaccinated with a booster dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation). Within 3 days of vaccination, the patient developed a rash on the torso described as sandpaper. the patient sought unspecified medical attention. Addition information has been requested. Y U OTH OTH UNk UNK WAES00051871 1
0170776 06/01/2001 MA 22.0 22 F 05/30/2001 Fever: Appetite Change; Arthralgia, Malaise,myalgia, Lymphadenopathy, asthenia, fatigue, -- Information has been received from a health care professional concerning a 22 year old caucasian female patient who on 22 May 2000 was vaccinated SC with a second dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) (lot #0300B - invalid). There was no concomitant medication or past medical history. On 24 May 2000 the patient experienced fever, fatigue, general malaise, decreased appetite, joint aches and muscle aches and bilateral swollen maxillary glands. On an unspecified date the patient recovered. Additional information has been requested. Y 05/22/2000 05/24/2000 2 PVT PVT NONE WAES00061956 1
0170777 06/01/2001 NY 46.0 M 05/30/2001 Vesiculosullous rash, asthenia, fatigue, skin erythema - Information has been received from a physician's assistant concerning a 46 year old caucasian male who on 17 Jun 2000 was vaccinated with one dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) (lot 16765 reported - invalid lot number) IM in the right deltoid. On 18 Jun 2000 the patient experienced a papulovesicular rash on the neck and trunk and erythema. The patient was afebrile. The patient also experienced tiredness. There were no lymph nodes involved. Laboratory tests indicated a rubella titer was negative. A strep culture was negative. On 21 Jun 2000 the patient recovered. No further information is available. Y Y 06/17/2000 06/18/2000 1 Laboratory test - rubella titer negative throat culture - negative UNK UNK UNK UNk WAES00062072 1
0170778 06/01/2001 F 05/30/2001 The pt has had 2 doses of MMRII and has not developed any antibodies. Additional info has been requested Y U 04/01/1991 Diagnostic laboratory-not detectable antibodies after 2 doses of MMRII OTH OTH Unknown Unknown WAES00062955 1
0170779 06/01/2001 MO M 05/30/2001 Lack of response - Information has been received from a pharmacist concerning a male who in 1990 and 1991 was vaccinated with the first and second dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation). Concomitant therapy included finasteride (MSD). In 2000 the patient had no detectable antibodies. Additional information has been requested. Y U 01/01/1991 01/01/2000 3287 diagnostic laboratory - no detectable antibodies OTH OTH Propecia 1 mg UNK WAES00062964 1
0170780 06/01/2001 MD 26.0 F 05/30/2001 Injection site rash - Information has been received from a physician concerning a 26 year old female who was vaccinated with one dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation). Concomitant therapy included one dose of tetanus toxoid, one dose of hepetitis b vaccine (manufacturer unknown) and one dose of Modimmune. Subsequently the patient developed a 5-6 cm red rash approximately 5 minutes post - injection. The rash was located at the measles (=) mumps (+) rubella (MSD) vaccination site. Unspecified medical attention was sought. Additional information has been requested. Y U OTH OTH UNK WAES00082973 1
0170781 06/01/2001 CA 33.0 F 05/30/2001 Lack of Response - Information has been received from a woman in a physician's office concerning a 33 year old female who was vaccinated with four doses of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation). Subsequently the patient has not seroconverted to measles U diagnostic laboratory - lack of seroconversion to measles OTH OTH UNK UNK WAES00063195 1
0170782 06/01/2001 CA 4.0 M 05/30/2001 On 6/26/00, pt developed mumps. The pt sough unspecified medical treatment. Addtl info has been requested. Y U 06/19/2000 06/26/2000 7 UNK UNK UNK UNK WAES00063239 1
0170783 06/01/2001 MI 5.0 5 F 05/30/2001 Information has been received from a registered nurse concerning a 5 year old female patient with no past medical history who on 27 June 2000 at 15:00 was vaccinated SC in the left upper arm with a second dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) (lot #632456/0173K). Concomitant vaccinations on 27 June 2000 included a fifth dose IM in the right thigh of alum, potassium (+) diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid (tripedia) and a fourth dose SC in the right arm of poliovirus vaccine (ipol). There were no illnesses at the time of vaccination. On 27 June 200 at 22:00 the patient experienced a fever of 100-101 degrees fahrenheit, accompained by fatigue for 5-6 days. The patient's skin has noted to be hot to the touch with the upper arm, from the shoulder to below the elbow, to be swollen to twice the normal size. The upper are was blood red looking for 5 days. Subsequently a band of tissue 1 1/2 inches around the site appeared. The skin around this area was black (bruised) for 10 days. Unspecified medical attention was sought and the patient was treated with ice, diphenhydramine hydrachloride (benadryl) and ibuprofen (Motrin). On an unspecified date the patient recovered from her experiences. It was noted that the patient always has fever and 1-2 days of fatigue following vaccines. No further information is expected. Y Y 06/27/2000 06/27/2000 0 PVT PVT NONE Medical History: asthenia/fatigue; fever WAES00064662 1
0170784 06/01/2001 CO 1.25 1 .3 F 05/30/2001 Rash, Fever, Measles Information has been received from a physician concerning a 15 month old adopted female who on 15 Jun 2000 was vaccinated with the first dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) (lot #634417/0260K) in the right thigh. Subsequently, a few days post vaccination, the patient developed a rash and fever which resolved. On 26 Jun 2000 the patient devloped a low grade fever and was cranky with a measles-like rash described as scattered erythmatous, maculopapular lesions starting that night. On 29 June 2000 the patient was seen by the physician and the patient had regular measles all over her body with no fever. The physician expressed a concern with the lot. on an unspecified date the patient recovered. No further information is available. Y Y 06/15/2000 06/18/2000 3 PVT PVT UNK UNK WAES00064669 1
0170785 06/01/2001 NY 51.0 M 05/30/2001 Information has been received from a physician concerning a healthy 51 year old male with no past medical history who on 06-June 2000 was vaccinated with one dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) ( manufacturer unknown). There was no concomitant medication. On 18 June 2000, the patient developed utricaria, server hives and angloedema which was still present on 30 Jun 2000 except when on disphenhydramine (Benadryl). The reporter noted that the patient was negative for hepatitis, had normal thyroid function and no other allergies. The patient sought unspecified medical attention. Additional information has been requested. Y N 06/06/2000 06/18/2000 12 Diagnostic laboratory 06/22/2000 comments - negative for hepatitis, thyroid function test 06/22/2000 comments - normal. OTH OTH NONE NONE WAES00070024 1
0170787 06/01/2001 FL 1.0 M 05/30/2001 Hypersensitivity reaction: irritability; otitis - Information has been received from a consumer concerning her 12 month old caucasian son with no known allergies who on 13 June 2000 was vaccinated with a second dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) (KED) (Lot # 631449/0107K) given in the left thigh. concomitant vaccinations that same date inculded one dose of varicella virus vaccine live (msd) and a dose of Haemophilus D conjugate vaccine (manufacturer unknown). Other concomitant therapy included prednisone and hydroxyzine dihydrochloride (atarax). On approximately 03 Jul 2000 the patient broke out in a rash and MD classified it as erythema mediforme. The patient's mother stated that the rash started on the legs and spread to the entire body almost resembling chicken pox. It was reported that the patient sought unspecified medical attention. Follow-up information received from the physician indicated that on 27 Jul 2000 the patient devloped fussyness with evidence of severe otitis and amoxicillin triphydrate (Amoxil) was started. On 03 Jul 2000 the physicaian indicated that the amoxicillin trihydrate (Amoxil) was stopped due to the rash development. On 04 Jul 2000 thepatient was seen in the emergency room and the rash was thought to be secondary to the amoxicillin triphydrate (Amoxil) and the physician now considers the patient to have an amoxicillin triphydrate (amoxil) allergy. The patient was seen by the physician on 05-Jul-2000 and 06-Jul-2000 and it was reported that the rash was gone by 10 Jul 2000 and the patient recovered. No further information is expected. Y Y 06/13/2000 06/27/2000 14 PVT OTH Atarax, Prednisone UNK WAES00070586 1
0170788 06/01/2001 WA F 05/30/2001 Upper extremity edema: Injection site induration; skin erythema-- Information has been received from a health care department concerning a female patient who was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation). Subsequently the patient experienced left arm swelling, erythema and induration in the injected arm. It was noted by the reporter that the patient's experiences were attributed to the measles (+) mumps (+) rubella vaccine. Follow up information from the health care facility indicated that there was no new information. U OTH OTH UNK UNK WAES00070638 1
0170789 06/01/2001 CA 1.08 1 .1 F 05/30/2001 Rash, Fever, Information has been received from a physician concerning a 13 month old female who on 1 Jul 2000 was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation). It was noted no known exposure to wild type virus. Concomitant therapy included varicella virus vaccine live (MSD). On 10 July 2000, the patient experienced fever and on 11 Jul 2000 the patient experienced erythematous maculopapular like rash. The patient sought unspecified medical attention. Additional information has been requested. Y U 07/01/2000 07/10/2000 9 body temp comment- fever OTH OTH WAES00070861 1
0170790 06/01/2001 CA 3.5 3 F 05/30/2001 Rash, fever, pruritus - Information has been received from a consumer concerning her 4 year old daughter with a past medical history of possible rolandic seizures and no known allergies who in approximately April 1999 was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation). There was no concomitant medications. Approximately 10 days post-vaccination the patient had a fever and broke out in an itch/rash all over her body. The patient sought unspecified medical attention. The patient's sister (WAES #00071056) had a similar experience following exposure to measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation). Follow up information from the physician indicated that the patient had no adverse reactions related to the measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation). No further information is expected. Y U 04/01/1999 04/01/1999 0 OTH OTH NONE Medical History: seizure ~Measles + Mumps + Rubella (no brand name)~~0.00~In Sibling|~Measles + Mumps + Rubella (no brand name)~~0.00~In Sibling WAES00070872 1
0170791 06/01/2001 IL 1.25 1 .2 M 05/30/2001 Information has been received from a registered nurse concerning a 15 month old African-American male patient with no known allergies or medical history and no known illnesses who on 19-May2000 was vaccinated subcutaneously with a first dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second genration) (lot 633752/1709J). Concurrent vaccinations that same day included a fourth dose of diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid (lot # 7390-AA) given intramuscularly, a fourth dose of haemophilus b conjugate vaccine ( lot #468-488) given intramuscularly, and a third dose of poliovirus vaccine (IPOL) (lot # R0618) given subcutaneously. On 26 May 2000 the patient developed a fever of 104F. It was stated that no obvious rash was noted. The patient sought unspecified medical attention. It was reported that an additional patient (WAES # 00070995) had a similar experience following exposure to measles virus vacciine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second genration). Y 05/19/2000 05/25/2000 6 body temp 05/25/2000 104F, body temp 05/01/2000 101-102f PVT PVT NONE WAES00070993 1
0170792 06/01/2001 IL 1.25 1 .2 F 05/30/2001 Information has been received from a registered nurse concerning a 15 month old caucasian female patient with lactose intolerences who on 10 jun 2000 was vaccinated subcutaneously with a first dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) (lot # G32456/0173K). Concomitant vaccinations that same day included a fourth dose via intramuscular administration of diphtheria toxioid (+) pertussia vaccine (+) tetanus toxoid (Lot # U0276RA), a fourth dose via intramuscular administration of haemophilus B conjugate vaccine ( Lot # 622363A), and a third dose via subcutaneous injection of poliovirus vaccine (IPOL) (Lot #r091). On 20 Jun 2000, the patient experienced a measles like rash. The patient sought unspecified medical attention. It was reported that an additonal patient (waes# 00070993) had a similar experience following exposure to measles virus vaccine live (+) mumps virus vaccine live (+) rubella viurs vaccine live (second generation). Follow up information from the registered nurse indicated that on 20 Jun 2000 the patient developed a rash which started on her face and then spread to her her trunk. The patient was seen by the physician and the rash was thought to be consistent with a measles rash. Subsequently the patient has recovered. No further information is expected. Y Y 06/10/2000 06/20/2000 10 PVT UNK concurrent conditions: lactoso intolerance WAES00070995 1
0170793 06/01/2001 IL 4.0 4 M 05/30/2001 Morbilliform Rash; Information has been received from a registered nurse concerning a 4 year old caucasian male patient with no known allergies and no past medical history who on 19 Jun 2000 was vaccinated SC in the right arm with a second dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) (lot # 634417/0260K). Concomitan vaccinations on 19 June 2000 included a fifth dose IM in the left deltoid of diphtheria toxoid (+) pertussia vaccine (+) tetanus toxoid and a fourth dose SC in the left arm of poliovirus vaccine (IPOL). On 23 Jun 2000 the patient's mother notified the physician's office that the patient had developed a measles-like rash. follow up information from a registered nurse reported that the patient subsequently recovered. Y 05/19/2000 06/23/2000 35 PVT PVT NONE WAES00070997 1
0170794 06/01/2001 CA F 05/30/2001 Rash, fever, pruritus - Information has been received from a consumer concerning her daughter who in approximately April 1999 was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation). approximately 10 days post-vaccination the patient had a fever and broke out in a itch/rash all over her body. The patient sought unspecified medical attention. The patient's sistem (WAES #00070872) had a similar experienced following exposure to measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation). Additional information has been requested. Y U 04/01/1999 04/01/1999 0 UNK UNK UNK UNK ~Measles + Mumps + Rubella (no brand name)~~4.00~In Sibling|~Measles + Mumps + Rubella (no brand name)~~4.00~In Sibling WAES00071056 1
0170795 06/01/2001 CA 1.5 1 .3 M 05/30/2001 Fever, rash, pruritus - Information has been received from a registered nurse concerning a 16 month old East Indian male patient with hypotonia since birth and poor suck and swallow reflex who on 03 Jul 2000 was vaccinated in the left buttock with a first dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation ) (lot #633095 /0254K). It was noted that the patient was diagnosed with left otitis media at the time of vaccination and was placed on therapy with amoxicillin. On 12 July 2000 the patient experienced a high fever of 102-103 Fahrenheit and a generalized itchy rash. The patient was advised to give her son a fever reducer and a lukewarm bath. If the fever peraisted she was to bring the baby into the office. On 15 Jul 2000 the patient recovered. Two additional patient (Wases # 000713119) had a similar experience. The reporter expressed a concern with the lot number. No further information is available. Y 07/03/2000 07/12/2000 9 UNK UNK amoxicillin otitis media concurrent conditions; hyporeflexia, hypotonia WAES00071118 1
0170796 06/01/2001 CA M 05/20/2001 Fever, Rash - Information has been received from a registered nurse concerning a male patient who was vaccinated with one dose measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) (lot #633095/0254K). subsequently the patient experienced a high fever of 104 fahrenheit and a generalized itchy rach. unspecified medical attention was sought. Two additional patients (Waes is 00071009 & 00071118 had a similar experience. The reporter expressed a concern with the lot number. Additional information has been requested. Y U UNK UNK UNK UNK WAES00071119 1
0170797 06/01/2001 CA 1.25 1 .2 F 05/30/2001 Rash, Fever - Information has been received a registered nurse from concerning a 15 month old female patient who on 6 Jul 2000 was vaccinated with one dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) (lot #633095/0254K). On 14 Jul 2000 the patient experienced a generalized rash and a fever of 39.8 celsius. unspecified medical attention was sought. On 16 Jul 2000 the patient recovered. Addition information has been requested. Y Y 07/06/2000 07/14/2000 8 UNK UNK UNK UNK WAES00071355 1
0170798 06/01/2001 AK 40.0 F 05/30/2001 Lack of Response- Information has been received from a health care professional concerning an approximately 40 year old pregnant female who is approximately 1990 was vaccinated with one dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation). Subsequently the patient was negative on titer. Follow up was received which indicated the reporter did not fell as if this case was and adverse event. additional information has been requested. Y UNK UNK WAES00071549 1
0170799 06/01/2001 PA 1.08 1 .1 F 05/30/2001 Asthenia / fatigue; Mental status change, photophobia, roseola - Information has been received from a physician concerning a 1 year old female who on 26 June 2000 was vaccinated with the first dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation). Concomitant therapy included the first dose of Haemophilum S conjugate vaccine (Hib Titer). On 05 Jul 2000 the patient experienced a fever and lethargy. The patient then developed a macular papular rash which began on her face and descended to the rest of the body. On 08- July 2000 the patient experienced photophobia and had a questionable mental change. The patient sought medical treatment. Lab work from 17 Jul 2000 revealed a positive IgG and Igm was negative for antibodies to the measles virus. A white count was 6000 with a differential that included 69% lymphocytes. The reporting physician thought it was roseola. On 12 Jul 2000 the patient recovered from all of her symptoms. Additional information has been requested. Y Y 06/26/2000 07/05/2000 9 diagnostic laboratory 07/17/00 comment- differential --69% lymphocytes, Immunoglobulin G index 07/17/2000 comment- positive, serum immunoglobulin N 07/17/00 comment - negative for IgM antibodies to the measles virus, NBC count 07/17/00 value unit- 4000 PVT OTH UNK WAES00071712 1
0170800 06/01/2001 TX 1.0 1 .0 M 05/30/2001 Rash - Information has been received from a company representative concerning a 12 month old male patient who on 22 May 2000 was vaccinated with one dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation). Conmitant vaccination that same day included one dose of varicella virus vaccine live (KSD). On 26 May 2000, the physician was informed that the patient developed red maculopapular eruptions scattered over his body. Unspecified medical attention was sought. Follow up information from the health care facility indicated that there were no other adverse reaction Y 05/22/2000 05/26/2000 4 OTH OTH UNK WAES00071995 1
0170801 06/01/2001 1.25 1 .3 F 05/30/2001 Measles - Information has been received from a pharmacist concerning her 15 month old female relative with no past medical history or allergies who on 11 Jul 2000 was vaccinated with one dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) (Lot # 630633/0102K). There was no concomitant medication. Right days late, the patient developed a mild fever. Ten days post-vaccination, the patient developed a rash and then the next day she was covered in rash from head to toe. The patient sought medical attention from a physician who diagnosed it as a case of measles. The reporter stated there was no exposure to natural measles. Additional information has been requested. Y U 07/11/2000 07/19/2000 8 OTH OTH None None WAES00072189 1
0170802 06/01/2001 WA 11.0 11 F 05/30/2001 Range Of Motion Decreased; Injection site erythema; injection site swelling; pain - Information has been received from a registered nurse concerning an 11 year old white female patient who was inadvertently vaccinated on 24 July 2000 with a second dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) IM in the left deltoid rather that the recommended SC route (lot number: 634035/37103). concomitant vaccinations that same day included a first dose of hepatitis b vaccine (engerix-b) IM in the right deltoid (lot number: em 33232a4). Follow up information from a relative of the patient indicated that one hour and fifteen minutes post-vaccination, the patient developed increased pain and decreased range of motion with localized redness and swelling for approximately one week before symptoms were completely resolved. On 01 Aug 2000 the patient recovered. The patient sought unspecified medical attention. Attitional information has been requested. Y Y 07/24/2000 07/24/2000 0 PVT OTH NONE WAES00072223 1
0170803 06/01/2001 NJ 32.0 F 05/30/2001 Rash - Information has been received from a registered nurse concerning a 32 year old female patient who on 11 Jul 2000 was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation). Subsequently, the patient developed a small, diffuse rash on her body including her trunk, face and extremities. Additional information has been requested U 07/11/2000 OTH OTH UNK UNk WAES00072248 1
0170804 06/01/2001 TX 1.0 1 .0 M 05/30/2001 Information has been received from a company representative concerning a 12 month old male pt who on 6/7/00 was vaccinated with MMRII, varicella and a 4th dose of haemophilus b conjugate vaccine. On 6/26/00, the pt developed a rash on his arms and legs and itchy umbilicated papules on his upper body and extremities. The physician indicated that the rash was molluscum contagious. The pt was not hospitalized. It was reported that the pt subsequently recovered. Follow-up information from the health care facility received on 11/6/00, indicated that no other adverse reactions occurred. No further information is expected. Y Y 06/07/2000 06/26/2000 19 OTH OTH UNK WAES00072524 1
0170805 06/01/2001 TX U 05/30/2001 Information has been received from a licensed visiting nurse concerning an unidentified pt who was vaccinated with a 1st dose of inadvertently vaccinated with a 2nd dose of MMRII on 9/19/99 and 07/31/00, respectively. Subsequently, after the 2nd dose, on 7/31/00, the pt experienced "swelling, 1/2" wheal and an area that is red and hot." The pt sought unspecified medical attention. Additional information has bee requested. Y U 07/31/2000 07/31/2000 0 OTH OTH UNK UNK WAES00080023 1
0170806 06/01/2001 AZ 1.25 1 .3 F 05/30/2001 Information has been received from a licensed practical nurse concerning a 15 month old female pt with a history of erythema multiforme following exposure to varicella virus vaccine live (MSD) (WAES 00072512) who was vaccinated with a 1st dose of MMRII SC in the left leg. That same day the pt also had a 4th dose of Haemophilus B conjugate vaccine IM in the left leg. On 7/26/00, the pt developed erythema multiforme. Unspecified medical attention was sought and the pt's experience was thought to be an allergy and treated at the time of the occurrence. Follow-up information from a physician indicated that "10 days, post vax, the pt developed red target lesions and urticarial rash (had a similar reaction to the varicella virus vaccine before". On 7/30/00, the pt recovered. Y Y 07/17/2000 07/26/2000 9 OTH PVT Erythema multiforme minor; vaccine allergy Erythema multiforme minor~Varicella (Varivax)~~0.00~In Patient WAES99979989 1
0170807 06/01/2001 TX 4.0 4 F 05/30/2001 Information has been received from a company representative concerning a 4 year old female who on 7/27/00 was vaccinated with a dose of MMRII. Subsequently, the pt experienced a rash and welts. Additional information has been requested. U 07/27/2000 OTH OTH UNK UNK WAES00080106 1
0170808 06/01/2001 NY U 05/30/2001 Information has been rec'd from a company representative who rec'd the info from a Nsg concerning a pt who on an unspecified date was vaccinated with 1 dose of MMR vaccine. 2 to 3 wks post vaccine, the pt developed a disseminated measles type rash. The reporter was unable to provide the lot # at the time of the report. The pt sought unspecified medical attention. Also reported was a male pt (WAES# 00110044) who was vaccinated and experienced similar events. No further info is available. Y U OTH OTH UNK UNK WAES00080227 1
0170809 06/01/2001 WA 1.3 1 .3 M 05/30/2001 Immediately post vaccination, the pt developed erythema at the injection site. the erythema faded within 5 minutes of onset. The pt was observed for 15 minutes and was reported as being ok. It was noted that 5 weeks prior vaccination the pt had a similar reaction to varicella vaccine. Y 07/07/2000 07/07/2000 0 OTH OTH allergy, asthma, eggs allergy, wheat allergy injection site wheal~Varicella (Varivax)~~1.25~In Patient WAES00080312 1
0170810 06/01/2001 MN 5.0 4 M 05/30/2001 On 04/30/00 pt developed a sore throat, runny nose, headache, and fever. On 05/30/00 the pt presented at clinic and was found to have enlarged bilateral parotid glands. On 05/04/00 a mumps titer was drawn and came back equivocal. The health department stated that this a a lab (-) case of mumps. ON 05/12/00, the pt recovered, however, on 07/21/00 a convalescent IgG was drawn which remained at greater than four-fold increase. No further information is expected. Y Y 08/17/1999 04/30/2000 257 serum immunoglobulin G 05/04/00 1:64-acute 8-fold INC serum immunoglobulin G 07/21/00 >1:64-convalescent>4 fold INC serum immunoglobulin M 05/04/00 1:10 <1:10 equivocal serum immunoglobulin M 05/12/00 1:40 <1:10 4 fold INC PUB PUB NONE Ceclor allergy, iron deficiency anemia WAES00080343 1
0170811 06/01/2001 MN 1.0 1 .0 M 05/30/2001 On 7/7/00 the pt presented to the ER with orchiditis. His left testicle was swollen. A measles/rubella titer was obtained to rule out mumps. The IgG test was reactive for rubella and measles, however mumps was negative. An IgM for mumps was ordered and revealed borderline acute illness. Additional information has been requested. Y U 12/15/1997 07/07/2000 935 lab test - neg for mumps, reactive for rubella, borderline for acute illness PUB PUB UNK hydrocephalus WAES00080347 1
0170812 06/01/2001 KY F 05/30/2001 Cutaneous Nodule, Dizziness, Asthenia/Fatigue, Secondary transmission - Information has been received from a female consumer who was exposed to her one year old female niece who was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) (date not reported). Subsequently, the reporter sexperienced bumps on face and a few scattered throughout the rest of her body. She also experienced dizziness and lethargy. The experience of the one year old female is reported in waes# 00111523. Additional information has been requested. U UNK UNK UNK UNK WAES00080474 1
0170814 06/01/2001 FL 0 .2 M 05/30/2001 Fever - Information has been received from a physician concerning a male patient who on 03 Jan 1994, at 2 months old was vaccinated with a first dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation). Subsequently the patient experienced a fever. Unspecified medical attention was sought. The patient received the next two doses of measles (+) mumps (+) rubella virus vaccine live (second generation) according to the schedule. The physician inquired as to whether or not there would be a problem with administering a fouth dose of mealses (+) mumps (+) rubella virus vaccine live (second generation). Additional information has been requested. Y U 01/03/1994 OTH OTH UNK UNK WAES00080996 1
0170815 06/01/2001 SD 26.0 F 05/30/2001 Lack OF Response - Information has been received from a registered nurse concerning a 26 year old while female reqistered nurse who on an unspecified date was vaccinated with a first and second dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation). Subsequently, the patient was tested only for antibodies to rubelin which were negative. The patient sought unspecified medical attention. Follow up information received on 19 sep 2000 from a physician's assistant indicated that on 15 sept 2000 the patient received a third dose of rubella virus vaccine live (second generation no further information is available. Y U diagnostic laboratory- normal range (-) comments (-) rubella PVT PVT UNK UNK WAES00081288 1
0170816 06/01/2001 FL F 05/30/2001 Fever- Information has been received from a consumer conserning her daughter who was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation). Sebsequently, the patient developed a high fever. Additional information has been requested. U OTH OTH UNK UNK WAES00081331 1
0170817 06/01/2001 KY 1.0 1 .0 M 05/30/2001 Injection site erythema narrower than 1 inch; injection site wheal - information has been received from a licensed practical nurse concerning a 12 month old caucasian male patient who on 03- Aug 2000 at 1:30 pm. was vaccinated subcutaneously in the right thigh with a first dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) (635125/0400k). Concomitant vaccinations that same day included a first dose of varicella virus vaccine live (msd) (lot #632613/1857J) administered subcutaneously via the left thigh. The patient developed a large wheal at the injection site that when treatec with ice resolved within 30 minutes. The reporter stated concern regarding the lot of the vaccine. It was reported that 3 other patients (waes 00382071 through 00082073 ) had a similar experience following exposure to measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation). Follow up information from the licensed practical nurse indicated that on 03 Aug 2000 the patient developed redness at the injection site 2 cm in diameter. It was reported that subequently the patient recovered. No further information is expected. Y Y 08/03/2000 08/03/2000 0 PVT PVT UNK WAES00061640 1
0170818 06/01/2001 TN U 05/30/2001 Injection site swelling, injection site erythema - Information has been received from a pharmacist concerning an unidentified patient who was vaccinated subcutaneously in the forearm with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation. Subsequently the patient developed a huge red swelling at the site of injection. The patient sought unspecified medical attention. Attitional information has been requested. Y U OTH OTH UNK UNK WAES00081791 1
0170819 06/01/2001 CO 9.0 9 F 05/30/2001 Injection site erythema, Injection site swelling - Information has been received from a physican concerning a 9 year old caucasian female patient with a history of cellulities after vaccination with a fifth dose of diphtheria - tetantus toxoids - acellular pertussia vaccine, who on 18 Aug 2000 was vaccinated with a second dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation (lot #635288/0583K). Within 30 minutes after vaccination, the patient developed erythema, and slight swelling surrounding the injection site. foxofonadine (Allegra) was administered to the patient at the doctor's office. It was reported that the patient's mom was upset, and they wer told to apply ice and diphenhydramine HCL (Benadryl). The Patient has antibiotic allergies to penicillin and arithromycin (zithromax). The patient has recovered. Y Y 08/18/2000 08/18/2000 0 PVT PVT UNK medical history: antibiotic allergy, cellulitis, penicillin allergy cellulitis~Diphtheria Toxoids (no brand name)~3~8.00~In Patient WAES00081868 1
0170820 06/01/2001 AZ F 05/30/2001 On 08/17/2000 the patient developed a fever of greater than 101F and was very achy. The following day the patient felt very fatigued throughout the weekend. Additional information has been requested. Y N 08/16/2000 08/17/2000 1 UNK UNK WAES00081993 1
0170821 06/01/2001 KY 11.0 11 M 05/30/2001 Injection Site Wheal - Information has been received from a health care professional concerning an 11 year old male patient who in approximately August 2000 was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live ( second generation ) (635125/0400K). Subsequently the patient developed a large wheal at the injection site that when treated with ice resolved within 30 minutes. The reporter stated concern regarding the lot of the vaccine. It was reported that 3 other patients (WAES # 00081640, 000829072 and 00082073) had a similar experience following exposure to measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation). No further information is expected. Y Y 08/01/2000 08/01/2000 0 UNK UNK UNK UNK WAES00082071 1
0170822 06/01/2001 KY 10.0 10 M 05/30/2001 Injection site wheal - Information has been received from a health care professional concerning a 10 year old male patient who in approximately August 2000 was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation ) (635125/0400K). Subsequently the patient developed a large wheal at the injection site that when treated with ice resolved within 30 minutes. The reporter stated concern regarding the lot of the vaccine. It was reported that 3 other patient (WAES #00081640, 00082071, and 00082073) had a similar experience following exposure to measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) . Additional information has been requested. Y Y 08/01/2000 08/01/2000 0 OTH OTH UNK UNK WAES00082072 1
0170823 06/01/2001 KY 1.08 1 .1 M 05/30/2001 Injection site Wheal - Information has been received from a health cre professional concerning a 1 year old male patient who is approximately August 2000 was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) (635466/0782k). Subsequently the patient developed a large wheal at the the injection site that when treated with ice resolved within 30 minutes. the reporter stated concern regarding the lot of the vaccine. It was reported that 3 other patients (Waes #0008164, 00082071 and 000282072) had a similar experience following exposure to measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation). No further information is expected. Y Y 08/01/2000 08/01/2000 0 UNK UNK UNK UNK WAES00082073 1
0170824 06/01/2001 NJ 26.0 F 05/30/2001 It was noted at the time of the vaccination there were no illnesses. On approximately 03/07/2000 the patient sought unspecified medical attention and was found to not have any detectable IpG antibodies to rubella. Additional information has been requested. Y U UNK UNK UNK NONE WAES00082185 1
0170825 06/01/2001 NY 5.0 1 .0 F 05/30/2001 Post vax the patient experienced an anaphylactic reaction to the vaccine. Medical attention was sought and the reporting physician felt the reaction was related to the MMR vaccine. On 03/29/1996 the patient experienced a high fever of 104.8F. She was less active, was crying and whining although she had been taking fluids and wetting her diaper. There was no vomiting or diarrhea. The physical examination was normal. The patient was treated with ibuprofen. No further information is available. Y Y 03/27/1996 03/27/1996 0 PVT OTH UNK UNK WAES00082603 1
0170826 06/01/2001 GA U 05/30/2001 Rash - Information has been received from a pharmacist concerning a patient who was vaccinated with one with one dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation). Two to three weeks post vaccination the patient developed a rash (not described). Unspecified medical attention was sought. Additional information has been requested. Y U OTH OTH UNK UNK WAES00082705 1
0170827 06/01/2001 IL 1.0 0 .6 M 05/30/2001 Measles, Fever - Information has been received from a lisensed practical nurse concerning a 12 month old caucasian male patient with a history of otitis media, and pre - existing conditions of a tongue disorder and asymmetry of his ears who in approxiamately 1996 was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation). On 31 may 1996 the patient developed a measles type rash. Unspecified medical attention was sought. Follow up information from a physician indicated that on 31 May 1996 the patient developed a fever and severe rash. The patient was seen by a physician an 05 Jun 1995 with a rash consistent with mealse. Three weeks post onset, the patient recovered. Y Y 01/01/1996 05/31/1996 151 OTH OTH UNK Medical History : otitis media Concurrent conditions; otis disorder; tongue disorder WAES00082967 1
0170828 06/01/2001 NY 30.0 M 05/30/2001 Information has been received from a physician concerning an approx. 30 year old male pt from another country, who was vaccinated with a dose of MMRII. Subsequently, the pt developed measles. The pt sought unspecified medical attention. Follow-up information from the physician indicated that approx. 10 days, post vax, the pt developed a speckled rash over his trunk with a low-grade fever and some discomfort, questionable malaise. The physician indicated that it was a mild case of measles and he recommended the causal interventions; rest, fluids, acetaminophen, no aspirin and to return promptly to the physician's office if any symptoms worsen. It was reported that the pt was not known to be previously vaccinated against measles. Additional information was requested. Y U OTH OTH UNK UNK WAES00083050 1
0170829 06/01/2001 CT 1.3 M 05/30/2001 Injection site wheal - Information has been received from a physician concerning a 16 month old male patient who was vaccinated with one dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation lot 632532/1270J in the arm. Concomitant vaccinations administered that same day included one dose of varicella virus vaccine live (msd) in the arm. It was noted that the 2 vaccinations were administered in opposite arms. Within 5 minutes of vaccination, the patient developed a local reaction at the measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation injection site described as a twentyfive cent urticarial lesion. There were no other symptoms. The patient was treated with diphenhydramine HCL Benadryl. The patient's symptoms resolved in less than 1 hours. There was no reaction to varicella virus vaccine live (MSD). The patient had a serum multiallergen radioallergoeorbent test and was found to be negative for gelatin and egg. It was noted that 2 months later the patient was vaccinated with Hib (lederle vaccine) and had a similar reaction. Y Y Serum multi allerges normal range - gelatin and egg: negative UNK UNK UNK WAES00090091 1
0170830 06/01/2001 IL F 05/30/2001 Lack Of response- information has been received from a registered nurse concerning a female foreign student who was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation. Sebsequently, it was reported that titer levels were not detactable for rubella. Unspecified medical attention was sought. Additional information had been requested. Y diagnostic laboratory normal range - , comment titer not detectable for rubella OTH OTH UNK UNK WAES00090739 1
0170831 06/01/2001 CA 37.0 36 F 05/30/2001 Application Site reaction: cellulitis; induration - Information has been received from a health professional concerning a 37 year old caucasian female patient with a history of asthma who on 30 Aug 2000 was vaccinated SC on the right with a third dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation lot #629535/1507J. On 31 Aug 2000 the patient developed a red spot for one week and was treated with ibuprofen. On 11 sep 2000 the patient was seen by a physician for increased redness and swelling. It was noted that there was a 55mm induration. There were no nodes in arm pit. The diagnosis was local reaction with questionable early celluitis. The patient was given a tetanus booster, cephalexin keflex mg qid x 7 days and hydrocortisone valerate westocort cream. Y U 06/30/2000 06/30/2000 0 UNK UNK UNK medical history : asthma WAES00090803 1
0170832 06/01/2001 GA 1.25 U 05/30/2001 Five days post vax, pt experienced a fever. Unspecified medical attention was sought. Addtl info has been requested. Y U OTH OTH UNK UNK WAES00091061 1
0170833 06/01/2001 FL U 05/30/2001 Pt experienced a rash and fever post vax. Medical attention was sought. No further info is available. Y U OTH OTH UNK UNK WAES00091580 1
0170834 06/01/2001 NY 1.0 1 .0 F 05/30/2001 Two days post vax pt experienced fever of 104.6. Medical attention was sought. No further info is available. Y U 03/29/1996 03/31/1996 2 OTH OTH UNK UNK WAES00091723 1
0170836 06/01/2001 PA F 05/15/2001 Information has been received from a physician concerning a female who was vaccinated with varicella virus vaccine live. Fourteen days, post vax, the pt experienced transverse myelitis. The transverse myelitis was considered to be an "Other Medical Event". Additional information has been requested. U OTH OTH UNK UNK WAES00092594 1
0170837 06/01/2001 MI 33.0 33 M 05/15/2001 Information has been received from a physician concerning a 33 year old male with an allergy to penicillin who on 2/1/01 was vaccinated with the 1 dose of varicella virus vaccine live (lot 636569/0926K). On 2/7/01, the pt experienced hives and not a varicella-like rash. The rash was non-raised. He was seen in the ER. Upon medical review, the hives were determined to be an "Other Medical Review". The pt was treated with a steroid and Benadryl, but did not have much relief. Additionally, on 2/9/01, the pt experienced swelling in his joints and serum sickness-like symptoms. The pt's hives persisted. The outcome of the pt's other experiences was not reported. No further information is available. Y U 02/01/2001 02/07/2001 6 UNK UNK UNK Penicillin allergy WAES01020848 1
0170838 06/01/2001 IL 6.9 6 M 05/15/2001 Information was received from a registered nurse and a physician concerning a 6 year old white male who on 01/08/01 was vaccinated SC in the right arm with a 1st dose of Varicella virus live. There was no illness at the time of vaccination. There were no concomitant medications reported. On approximately 01/17/01, the father of the patient reported to the physician's office that he noticed that his son had developed a "red, warm area, about the size of a quarter" at the injection site (right arm). On 01/19/01, the patient presented to the physician's office (also indicated by the physician as "no doctor visit") with a 5x5 cm erythema near the injection site, a 3x3 cm induration near the injection site. In follow-up the physician reported the child had developed "early cellulitis of the arm at the site of injection" on 01/19/01. The child was being treated with unspecified oral antibiotics. Upon internal review, signs of cellulitis, was determined to be an other important medical event. Follow-up information has been received that states the patient had cellulitis of the right upper arm that started on approximately 01/17/01 and lasted for one week. The patient was treated with oral antibiotics and the problem resolved. Additional information is not expected. Y Y 01/08/2001 01/17/2001 9 PVT PVT NONE UNK WAES01011885 1
0170839 06/01/2001 30.0 30 F 05/15/2001 The pt experienced allergic reaction, post vax, which was dx'd as cellulitis. Unspecified medical attention was sought and she was placed on therapy with Duricef for 1 week. The pharmacist reported that the pt discovered she was 6 weeks pregnant in the beginning of January. Her estimated date of delivery was 9/6/01. Upon internal review, cellulitis was determined to be an other important medical event. In follow up, the pharmacist reported that her sister delivered a healthy baby boy at term with no problems noted. The infant wasborn on approximately 09/17/01 and is "doing well" Additional information is not expected. Y U 11/01/2000 UNK UNK UNK Pregnancy (LMP-11/30/00) WAES01010900 1
0170840 06/01/2001 GA 3.0 F 05/15/2001 Information has been received from a Physician's Assistant concerning a 3 year old female who in 1998 was vaccinated with Varicella Virus live. In May 2000, the patient developed herpes zoster of the eye and was hospitalized. Additional information has been requested Y Y U 05/01/2000 UNK UNK UNK UNK WAES00102452 1
0170842 06/01/2001 MT 30.0 F 05/30/2001 On 9/21/00, pt experienced a fever of 102.6, headache, muscle pain, joint pain, nausea without vomiting, and diarrhea. Medical attention was sought. No further info is available. Y U 09/21/2000 OTH OTH UNK UNK WAES00091862 1
0170843 06/01/2001 MN U 05/30/2001 Pt was vaccinated with 2 doses of MMRII. Post vax pt experienced a negative antibody test for rubella. No further info is available. U Negative AB test to rubella OTH OTH UNK UNK WAES00092115 1
0170844 06/01/2001 KY 1.08 1 .1 M 05/30/2001 Day of receiving vax, pt developed redness at injection site 1 cm in diameter. Subsequently pt recovered. Y 08/15/2000 08/15/2000 0 PVT PVT UNK WAES00092215 1
0170845 06/01/2001 KY 11.0 11 M 05/30/2001 The day of receiving vax pt experienced redness at the injection site 2 cm in diameter. On an unspecified date the pt recovered. Another pt (WAES00092217) had a similar experience following exposure to MMRII. No further info is available. Y 08/03/2000 08/03/2000 0 PVT PVT UNK WAES00092216 1
0170846 06/01/2001 KY 10.0 10 M 05/30/2001 On 8/3/01 the pt experienced redness at the injection site, 1.5 x 2 cm in diameter. On an unspecified date, the pt recovered. Another pt (WAES00092216) had a similar experience following exposure to MMRII. No further info is available. Y 08/03/2000 08/03/2000 0 PVT PVT UNK WAES00092217 1
0170848 06/01/2001 NY 21.0 31 F 05/30/2001 Information has been received from a pharmacist concerning a pt who after vaccination experienced painful urination and frequency in urination. The pt also had an IUD in place. Medical attention was sought. No further information is available. Y U 09/25/2000 UNK UNK doxycycline Intrauterine device in place WAES00092330 1
0170849 06/01/2001 OH F 05/30/2001 Blister; Morbilliform Rash; streptococcal pharyngitis; Information has been received from a licensed practical nurse concerning an unidentified female patient who on 29 Aug 2000 was vaccinated with a second dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation. On 18 sep 2000 the patient developed blisters on her hands, feet and in her mouth and was seen by the physician. The patient also had a sore throat which was positive for strep and she was placed on amoxicllin at that time. She returned to the physician on 26 Sep 2000 with a measles like rash that the physicain felt might be a reaction to the amoxicillin. Additonal information has been requested. Y U 08/29/2000 09/18/2000 20 throat culture date 09-18-2000, normal range -, comment positive for strep OTH OTH amoxicillin UNK WAES00092349 1
0170850 06/01/2001 TX U 05/30/2001 Information has been received from a company representative concerning 3-5 children (males and females) who in 9/00, were vaccinated with MMRII (lot 636658/1141K). Seven days, post vax, the pts experienced rash and/or fever to 102F. There was a concern because all of the pts received vaccine from the same lot. The records of testing prior to release of this lot have been checked by Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. In follow-up, the physician reported she "did not have those records any longer and the reactions are as detailed as she knew." The physician reported that she was just reporting "an increased frequency of issues with one lot of vaccines, last year and did not have more details." No further information is available. Y U 09/01/2000 09/01/2000 0 OTH OTH UNK UNK WAES00100028 1
0170851 06/01/2001 PA 39.0 39 F 05/30/2001 Pharyngeal edema; asthenia / fatigue, chest pain, dysphea, fever; injection site erythema, injection site induration, neck pain, otic pain, Information has been recived from a physician concerning a female patient in her late thirties who in September 2000 was vaccinated IM with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generatin lot #635466 /0782K. One week later she was vaccinated with pneumococcal vaccine 23 polyvalent PNU -imune 23. Within 24 hours after vaccination with pneuomococcal vaccine 23 polyvalent (PNU-Imune 23) the patient experienced a swollen throat, shortness of breath, chest tightness (mostly in the lying position). Injection site redness and induration. The patient also experienced a fever of 99-100f which has persisted for the past four weeks. Follow up information indicated that the patient was a 30 year old with a history of recurrent herpes simplex. It was clarified that the measles virus vaccine live (+) mumps virus vaccine live (+) fubella virus vaccine live sencond generation lot # 635466*0728k was administered on approximately 05 Sep 2000 Im in the left deltoid. There were no illnesses at the time of vaccination. The follow up information also stated that one week later, on approximately 12 Sep 2000 the patient received in the left arm pneumococcal vaccine 23 polyvalent MSD which conflicts with the previously reported vaccine, pneumococcal vaccine 23 polyvalent pnu-immune 23. Twenty four hours after the vaccination with pneumoccal vaccine 23 polyvalent (MSD) the patient experienced a fever of 101F, erythema at the infection site and one week later developed left side neck pain into the left ear. Approximately 3 week later the patient continued to have a low grade temperature of 99-100f, fatigue shortness of breath, chest tightness, a choking feeling in the throat and increased pain. The patient was given amithromycin without improvement. No further information is available. Y N 09/05/2000 09/13/2000 8 PVT OTH concurrent conditions: herpes simplex WAES00100258 1
0170852 06/01/2001 TX 1.0 1 .0 M 05/30/2001 Fever, Sinusitis - Information has been received from a physician concerning a 12 month old male, who on 21 Sep 2000 was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation lot 633814/0990k. On 28 Sep 2000. the patient experienced fever 102.5 F and congestion. Subsequently, the patient recovered from the fever and congestion. Other patients were reported with unspecified adverse events following vaccination with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation (MSD) waes 00101346. In follow up the physician reported. I was just reporting an increase frequency of issues with one lot of vaccine last year and do not have more details. In follow up the records of testing prior to release of this have been checked by biologics Quality assurance and found to be satisfactory. The lot comply with the standards of the center for biologics evaluation and research and was released. No further information is available. Y 09/21/2000 09/28/2000 7 temperature measurement date 09-28-00 value unit 102.5F normal range - UNK UNK UNK WAES00100661 1
0170853 06/01/2001 ID 2.0 M 05/30/2001 Fever; Arthralgia - Information has been received from a registered nurse concerning a 2 year old caucasin male who was vaccinated with the first dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation subcutaneously. Concomitant vaccination that same day included a dose of diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid manufacturer unknown and a dose of poliovirus vaccine inactivated manufacturer unknown. Sebsequently 11 days later, the patient experienced temperature of 101F and joint tenderness. It was reported that the child was in Mexico after vaccination during this period and was treated with ibuprofen motrin. The patient's symptoms subsided after five days. In follow up it was reported that the patient's sysmptoms lasted for 3 days. Unspecified medial attention was sought. No further information is expected. Y Y UNK UNK unk WAES00100752 1
0170854 06/01/2001 TX 1.0 F 05/30/2001 Viral Exanthema - Information has been received from a health professional concerning a 1 year old female who on 19 Sep 2000 was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation. concomitant therapy included one dose of varicella virus vaccine live MSD and hib conjugate vaccine MSD. On 09-Oct 2000 the patient experienced virus exanthema. she experienced a rash with macular papular eruptions. The rash was all over the body except for the palms of the hands and soles of the feet. The reporter felt that virus exanthema was related to measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation. (MSD) On follow up, it was noted that no other / further adverse reactions occurred. Y U 09/18/2000 10/09/2000 21 OTH OTH UNK WAES00100844 1
0170855 06/01/2001 NY F 05/30/2001 Lack of Response - Information has been received from a registered nurse concerning a female who in 1970 was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation and received a booster of measles virus vaccine live (+) mumps virus vaccine live (+) rubella viurs vaccine live second generation in 1989. subsequently, the patient had no titer for measles. The patient was given measles virus vaccine live (MSD) 01/01/1989 diagnostic laboratory normal range -, comment had no titer for measles OTH OTH UNK UNK WAES00100984 1
0170856 06/01/2001 OR 46.0 F 05/30/2001 Rash; arthralgia; lymphadenopathy; malaise - Information has been received from a physician concerning a 46 year old female who on 28 Sep 2000 was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation. Subsequently the patient experienced a face and upper torso rash, malaise, joint pain and lymph node swelling. unspecified medical attention was sought. Follow up information indicated that the physician does not believe that be recorded the lot number for the measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation. information has been received from a physician who reports he is unable to identify the patient . No further information is available. Y U 09/28/2000 UNK UNK UNK UNK WAES00100999 1
0170857 06/01/2001 NC 49.0 F 05/30/2001 Rash, Arthralgia, Fever - information has been received from a pharmacist concerning a 49 year old female patient with no known allergies who on 28 Sep 2000 was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second geneartion lot 633094/0177k. Subsequently 14 days later, the patient experienced a fine rash, fever (temp ranges not given) and joint aches. The pharmacist said the patient probably had measles before vaccination. The patient sought unspecified medical attention. Additional information has been requested. Y U 09/28/2000 10/12/2000 14 UNK UNK UNK UNK WAES00101113 1
0170858 06/01/2001 TX U 05/30/2001 Condition unspecified - Information has been received from a physician concerning six patients who on 21 Sep 2000 were vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation lot 533814/0990k. subsequently, the patients experienced non severe, unspecified adverse events. Unspecified medial attention was sought. Another patient was reported with fever and congestion following vaccination with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation weas# 00100661. In follow up the physician reported she no longer had the records of these patients and could not recall the patients names or the reactions in detail. She stated, I was just reporting an increase frequency of issues with one lot of vaccine last year and do not have more details. In follow up the records of testing prior to release of this lot have been check by biological quality assurance and found to be satisfactory. The lot complies with the standards of the center for biologics evaluation and research and was released. No further information is available. Y U 09/21/2000 UNK UNK UNK WAES00101346 1
0170860 06/01/2001 VA 1.0 1 .0 M 05/30/2002 In 04/00, the pt developed a 1 cm by 2 cm red dermal nodule that was fairly soft superficially, but indurated deeper in the dermis of the vaccination site. In 06/00, a course of Cephalexin was tried and failed. In approximately 9/00 or 10/00, the pt was referred to a dermatologist who treated the red nodule with desoximetasone 0.25% emollient cream (TOPICORT Cream). The nodule was present for 5 months and resolved to a flat scar, still indurated like a "dermato fibroma" within 1 month of treatment with desoximetasone 0.25% emollient cream (Topicort Cream) in 08/02. It was reported that the patient (WAES01012173) had a similar experience following exposure to Varivax. Additional information is not excpected. Y N 03/31/2000 04/01/2000 1 PVT PVT NONE WAES00101512 1
0170861 06/01/2001 IN 1.0 1 .0 M 05/30/2001 Information has been received from a licensed practical nurse concerning a 31 month old male who on 3/20/99 was vaccinated with a varicella virus vaccine live (lot 626132/1548H, invalid) (lot number corresponds to MMR). There was no concomitant medication. The LPN reported that on 10/18/00, the pt presented with greater than 50 lesions, 100F fever and itching. Follow-up information from the LPN indicated that the pt was not vaccinated with varicella virus vaccine, but was vaccinated with MMRII. Additional information is not expected. Y U 03/20/1999 10/18/2000 578 OTH OTH NONE UNK WAES00101804 1
0170863 06/01/2001 NM 1.08 1 .0 F 05/30/2001 Information has been received from a physician concerning a 13 or 14 month old female child who on 9/5/00 or 9/19/00 was vaccinated with 1 dose of MMRI and 1 dose of varicella virus vaccine. Approx. 1 week, post vax, on approx. 9/12/00, the pt experienced ataxia and was hospitalized. Upon hospitalization, the child was evaluated by a neurologist and had a normal MRI. As of 10/18/00, the child was still symptomatic with ataxia. Follow-up information on 11/5/00, indicated that the pt was never hospitalized. As of 11/5/00, the child remained at home and symptomatic with ataxia. The physician "unfortunately was not able to get CSF on the child for PCR analysis, however he has sent blood work for unspecified tests. Follow-up information from the pediatrician indicated that the pt had a mild ataxia, with "very subtle" changes in her walking. He indicated that the ataxia and changes were more evident to the child's mother, than to the pediatricians and consulting pediatric neurologist. He stated that the child's mother felt that the child had a very "acute change" in her gait, manifesting in a lot of "falling down", beginning approx. 1 week, post vax, however, neither the pediatrician nor the pediatric neurologist observed any acute or significant ataxia. He also stated they have not identified any etiology for the child's symptoms and that it has taken several months for her to recover. He indicated the child's symptoms have "for the most part, resolved". A lumbar puncture was never done on the child. The pediatrician had no additional information to report. No further information is available. Y N 09/05/2000 09/12/2000 7 MRI-nml; Blood work OTH OTH UNK WAES00101863 1
0170864 06/01/2001 PA 19.0 M 05/30/2001 Information has been received from a pharmacist concerning a 19 year old male who on 10/24/00 was vaccinated with MMRII and within hours of vaccination, the pt experienced a migraine headache. Unspecified medical attention was sought. Additional information has been requested. Y U 10/24/2000 10/24/2000 0 UNK OTH OTH UNK UNK WAES00102226 1
0170865 06/01/2001 CA 1.25 1 .3 F 05/30/2001 Information has been received from a consumer concerning a 15 month old white female pt with no allergies who on 10/18/00 was vaccinated with the 1st dose of MMRII, IM, in the left thigh, a Hib conjugate vaccine and streptococcus pneumoniae vaccine (Prevnar). There was no illness at the time of vaccination. On approx. 10/18/00, the pt's mother reported that the pt developed a bad rash all over her body which appeared as "red, dark site". On 10/25/00, the pt saw her physician. The pt's rash subsequently, persisted. Follow-up has been received from a physician who reported that on 10/25/00, the pt developed a fever and a rash. The physician noted that the pt required no treatment and recovered. Additional information is not expected. Y Y 10/18/2000 10/25/2000 7 PVT PVT NONE WAES00102529 1
0170866 06/01/2001 NY 5.0 5 M 05/30/2001 Information has been received from a physician concerning a 5 year old white male who on 07/18/00 was vaccinated with the 2nd dose of MMRII, in the right thigh. Two to three weeks, post vax, the pt was seen in a physician's office, after having developed a disseminated measles-type rash. It was noted that the pt had a fine rash over both arms. The reporter also noted that the pt develo9ped an increased temperature of 101.6F, bilateral leg pain and an ulcer on the tip and left side of the tongue. The pt received treatment with fluids, acetaminophen (Tylenol) and ibuprofen (Motrin). On an unspecified date, the pt recovered. No further information is expected. Y Y 07/18/2000 08/01/2000 14 Temperature 101.6F PVT PVT UNK UNK WAES00110044 1
0170868 06/01/2001 TX 1.08 F 05/30/2001 Information has been received from a physician concerning a 13 month old female with an amoxicillin allergy (drug rash) who on approx. 10/20/00 was vaccinated with a 1st dose of MMRII, in the left leg. The pt's mother reported on 11/3/00 that "recently", the child's left leg was red and had an abscess formation. The pt sought unspecified medical attention. Additional information has been requested. Y U 10/20/2000 11/03/2000 14 OTH OTH UNK Amoxicillin allergy WAES00110451 1
0170869 06/01/2001 FL M 05/30/2001 Information has been received from an NP concerning a male who had titers drawn in 3/98 which were positive for mumps and rubella and negative for Rubeola. On 3/25/98, the pt was vaccinated with MMRII. The pt was vaccinated again on 4/17/98 with MMRII. Titers were drawn again and showed that he was negative for Rubeola. A 3rd dose of MMRII was given on 11/3/00. Additional information has been requested. Y U 04/17/1998 Titer-(+)Mumps & rubella and (-)Rubeola X 2 OTH OTH UNK UNK WAES00110460 1
0170870 06/01/2001 CA 1.0 1 .0 F 05/30/2001 Information has been received from an LPN concerning a 12 month old female who on 9/20/00 was vaccinated with the 1st dose of MMRII, a 1st dose of varicella virus vaccine and a 3rd dose of Hep-B. On 9/20/00, the same day of the vaccinations, the child experienced urticaria with rash and hives. The pt's experiences were intermittent for 5 weeks. The child was initially treated with Benadryl for a week. Benadryl was discontinued. On 10/23/00, the child was seen and prescribed Atarax. The reporter noted that the rash was not a vesicular rash. The reporter noted that another pt had an adverse experience following vaccination with MMRII and Hep-B (WAES 00110453). In follow-up information received from the nurse, it was reported that the pt's rash resolved for 2 weeks after hydroxyzine therapy and then "came back". The pt's father restarted hydroxyzine, "but only used (it) for a few days." As of 12/21/0, the pt's father reported the pt had experienced "hives off and on" and believed it was "food allergies". The reporter stated that the pt recovered; however, at the time of the report the pt still "had a few spots." No additional information is expected. Y N 09/20/2000 09/20/2000 0 PVT PVT UNK WAES00110479 1
0170871 06/01/2001 DC 15.0 15 M 05/30/2001 Rash, Fever, Headache - Information has been received from a physician concerning a 15 year old black male with behavioral problems and no known drug allergies who on 06 Nov 2000 was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation 636660/1127K. The physician reported that on 06 Nov 2000 at 5pm, the patient developed a maculopapular rash of about 40-50 papules isolated to the torso 4 hours after receiving the vaccine. The physician reported that pallative measures were administered by the patient's mother tetaminophen (tylenol) for headache/fever and bed rest. The physicain reported that the patient recovered 10 Nov 2000. No further information is available. Y 11/05/2000 11/06/2000 1 PUB PUB UNK Concurrent conditions; Behavioral disturbance. WAES00110795 1
0170872 06/01/2001 CT 29.0 29 F 05/30/2001 Phstyngeal Edema, Fever, Tongue Disorder - Information has been received from a registered nurse for an employee health center concerning a 29 year old caucasian female with codeine allergy exposure results in fever and vomiting, adhesive tape allergy exposure results in local rash and a local reaction swelling to be stings. On approximately 02 Nov 2000, the patient was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation. On 08 Nov 2000, the patient noted spots on her tongue, fever, and swollen throat. The patient's fever resolved in three days and she returned to work. The patient also recovered from the spots on her tongue and swollen throat. Additional information has been requested. Y 11/02/2000 11/08/2000 6 temperature measurement 11/08/2000, normal range - , comment fever UNK UNK UNK Concurrent Conditions; adhesive tape allergy, codeine allergy, insect sting allergy WAES00110929 1
0170873 06/01/2001 F 05/30/2001 Asthenia/Fatigue, behavioral disturbance, lymphauenopathy; Perspiration, fever - Information has been received from a pharmacist concerning her daughter who on 01 Nov 2000 was vaccinated with one dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation. Five days post-vaccination, the patient became very lethergic and unusually waking up at night screaming. It was also noted that the patient developed a fever and sweats. Ten days post vaccination, the patient developed swollen lymph glands in the groin area. The reporter was concerned about her daughter receiving a booster dose because she felt that her daughter had adverse reactions from the MMR vaccine. Additional information has been requested. U 11/01/2000 11/06/2000 5 OTH OTH UNK UNK WAES00111211 1
0170874 06/01/2001 PA 1.0 1 .0 F 05/30/2001 Rash - Information has been received from a licened practical nurse concerning a 12 month old female who was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generaton on 01 Nov 2000. On 13 Nov 2000. the patient experienced a rash and sought unspecified medical attention. The licensed practical nurse stated that the patient had no fever and no other symptoms. Additional information has been requested. Y U 11/01/2000 11/13/2000 12 UNK UNK UNK UNk WAES00111325 1
0170875 06/01/2001 1.0 F 05/30/2001 Information has been received from a female consumer concerning her one year old female niece who recived her first vaccination of mealses virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) date not reported. Sebsequently, the patient experience light case of measles. The experience of the reporter is described in waes # 00080474 Additonal information has been requested. U UNK UNK UNK WAES00111523 1
0170876 06/01/2001 TX 46.0 41 F 05/30/2001 Influenza - like diseases, Joint swelling - Information has been received from a 45 year old licensed visiting nurse who in 1996 was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation. The licensed visiting nurse reported that within 10 days of receiving the vaccine she experienced a temperature of 101. Swollen joints and flu like symptoms, she reported that those musculoskeletal symptoms persist to date. Additional information has been requested. N 01/01/1996 01/01/1996 0 UNK UNK UNK WAES00111564 1
0170877 06/01/2001 PA M 05/30/2001 Skin Erythema - Information has been received from a physician concerning a male who on 31 Oct 2000 was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation. Subsequently, the patient developed a red, erythematious streak on the right arm a little further down than injection site. The physician reported that the streak was above the anticubitial fossa. The patient sought unspecified medical attention and his outcome was unknown. Additional information has been requested. Y U 10/31/2000 UNK UNK UNK UNK WAES00112124 1
0170878 06/01/2001 NJ 37.0 37 F 05/30/2002 Rash - Information has been received from a physician concerning a 38 year old female with a penicillin allergy who on 21 Nov 2000 was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation. On approximately 22 Nov 2000 the patient experience pruritis rash with pox like lesions. As of 27 Nov 2000. the patients condition continued. Unspecified medical attention was sought. Additional information has been requested. This is a follow-up to report previously submitted on 5/30/01. Information has been received from a physician concerning a 38 year old female with a penicillin allergy, hypothyroidism, hypercholestermia, polyclona gammopathy and proteinuria who on 21-Nov-2000 was vaccinated in the left deltoid with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (sencond generation) lot # 637093/1260K). On approximatly 23-Nov-2000 the patient experienced a pruritic rash with pox like lesions. As of 27-Nov-2000, the patient's condition continued. Unspecified medical attention was sought. Follow-up information from the consumer who is a nurse reported that "approximately 36 hours post-vaccination she developed a pruritic rash that lasted for weeks." Follow-up information from a physician indicated that the patient developed red spots, like mosquito bites which were itchy with red dots and blotches. The patient was initially treated with diphenhydramine hydrochloride (Benadryl) and then took fexofenadine (Allegra) and famotidine that was recommended by the physician she works with. It was reported that the rash resolved after approximately 10 days on approximately 30-Nov-2000 and subsequently the patient recovered. No further information is expected. Y N 11/21/2000 11/22/2000 1 Measles titer - negative PVT PVT UNK concurrent condition: Hypercholesterolaemai;Hypothyroidism;Penicillin allergy;Polyclonal hypergammaglobulinaomia;Proteinuria WAES00112157 1
0170879 06/01/2001 CA U 05/30/2001 Arthiritis - Information has been received from a certified pharmacy technician concerning patients who were vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation. Subsequently, some patients complained of arthritic side effects. Additional information has been requested. U OTH OTH UNK UNK WAES00129216 1
0170880 06/01/2001 CA 4.0 4 M 05/30/2001 Choking; Cough; Agitation; emotional state, Facial edema, nasal congestion, unusual crying, urticaria, vomiting - Information has been received from a physician concerning a 4 year old male, with no drug allergies and no known allergies to eggs, who on 29 Nov 2000 was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation 636398/0828k. In the initial report, the physician stated that within 4 minutes, patient became very upset worked up began to cough, choke, scream and vomit and also had a rash and swollen lips. In follow up the physician reported that the patient cried when the injection was given, then seemed fine. The patient went to the waiting room, seemed congested, then got upset and vomited. Within 30 minutes, the patient developed swollen lips and hive like rash that persisted for about 6 hours. The rash was relieve and faded with diphenhydramine hydrochloride Benadryl. The physician reported that during the vomiting and swollen lip event, the patient was crying uncontrollably. The physician was uncertain as to whether the patient's reaction was a result of the measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) vaccine or from the child's own adrenaline. The physician reported that the patient recovered from his experiences on 30 Nov 2000. No further information is available. Y Y 11/29/2000 11/29/2000 0 PVT UNK UNK WAES00120393 1
0170881 06/01/2001 CA 60.0 60 F 05/30/2001 Fever, Arthralgia, Conjunctivitis - Information has been received from a physician concerning a 60 year old female who on approximately 29 Nov 2000 was vaccinated with measles virus vaccine live (+) mumps virus vaccine lie (+) rubella virus vaccine live (second generation since she had no prior immunity. On 08 Dec 2000, the patient presented to the physician with a 101.3 degree fahrenhelt fever. Arthrialgia and conjunctivitis. She did not have a rash or encephalitis. Additional information has been requested. Y U 11/29/2000 12/08/2000 9 UNK UNK UNK UNK WAES00120790 1
0170882 06/01/2001 MI 1.3 1 .3 M 05/30/2001 Vomiting: diarrhea: Malaise: unusual crying - Information has been received from a mother concrning her sone in approximately 1995 was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation 616251/0750B at the approximate age of 16 months. The patient's mother reported that her son received mealses virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation about 5 years ago and she stated I remember that he cried and creamed for hours after. She reported that he vomited and had diarrhea and a general malaisa for the following week. Unspecified medical attention was sought. Additonal information has been requested. Y U 10/21/1995 10/21/1995 0 UNK UNK UNK UNK WAES00120735 1
0170883 06/01/2001 3.25 3 M 05/30/2001 Rash - Information has been received from a reqistered nurse concerning a 39 month old male who on 29 Nov 2000 was vaccine with the first dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second geneation. Concomitant therapy included the first dose of hepatitits b vaccine recombinant yeast manufacturer unknown, one dose of varicella virus vaccine live (msd) hib conjugate vaccine manufacuturer unknown, and diphtheria Y U 11/29/2000 12/11/2000 12 UNK UNK UNK WAES00120663 1
0170884 06/01/2001 OR 35.0 35 F 05/30/2001 Measles, Mumps- Information has been received from a physician concerning a 35 year old femle with seasonal allergies that persist nine months of the year who in approximately July 1999 was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation. There were no concomitant medications. Within ten days of vaccination, the patient experienced a measles like rash and swelling of the right submandibular area. She was told at that time she had signs of mild measles and mumps. The patient recovered from the symptoms. The patient also had adverse experiences following vaccination with varicella virus vaccine live waes 00070374 Y 07/01/1999 07/01/1999 0 UNK UNK NONE Concurrent conditions; seasonal allergy skin lesion~Vaccine not specified (no brand name)~1~36.00~In Patient WAES00120924 1
0170885 06/01/2001 MI 1.25 1 .3 M 05/30/2001 Measles; gastroenteritis - Information has been received from a health professional concerning a 15 month old male who on 30 Nov 2000 was vaccinated with the first dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live sencond generation lot # 635455/0782k. concurrent therapy included the first dose of baricella virus vaccine live site unknown (MSD) 635606/1152K and he first dose of hepatitis b vaccine recombinant yeast (msd) 636070/0494k. Other concomitant therapy included acetaminophen, ibuprofen motrin and amoxicillin. It was noted that 2 -3 days after the vaccination the patient developed viral gastroenteritis. On 09 Dec 2000 the patient developed a rash on his face which spread to his arms, a fever of 99.5 which was diagnosed as measles. On 11 Dec 2000 the patient presented with a three day history of erythpetous patchy rash over trunk and extremities which appeared like rash of rubeola in derm books. There were no koplick's spots, opharyngeal, erythema, lymphadenopathy, rhinorrhea of vesicles reported. It was noted that the patient recovered. It was also noted that the patient mother was checked for immunity and was immune. Y Y 11/30/2000 12/02/2000 2 PVT OTH acctaminophen, amoxicillin, motrin unk WAES00120971 1
0170886 06/01/2001 OK 15.0 15 F 05/30/2001 Abdominal Pain: hemorrhage - information has been received from a health professional concerning a 15 year old female who on 14 Nov 2000 was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation. On 16 Nov 2000 the patient experienced abdominal cramps. she was taken to the emergency room, subsequently the patient was found to be pregnant. Subsequently the patient experienced intermittent bleeding, LMP was 15 oct 2000. Expected date of delivery is 27 Jul 2001. No further information is abailable. Per F/U 8/9/02: The pregnancy was confirmed by a pregnancy test. Follow-up information has been received and indicated that the RN could not provide any additional information. No further information is available. Y U 11/14/2000 11/15/2000 1 Pregnancy test-(+) Per F/U 8/9/02 OTH OTH UNK Pregnancy NOS (LMP-10/15/00) WAES00121125 1
0170887 06/01/2001 PA F 05/30/2001 Laboratory Test Abnormality - Information has been received from a registered nurse concerning a student who in Novermbe 2000. Was vaccinated with mealses virus vacciene live (+) mumps virus vaccine live (+) rubella vurus baccine live second generation. subsequently the patients mother who was eights months pregnant experienced a higher than normal rubella titer. In follow up the nurse reported that she forwarded the forms to the student's mother and that she did not have the information necessary to complete the forms. additional information is expected. Y U 11/01/2000 diagnostic laboratory normal range -, comment higher than normal rubella titer UNK UNK UNk WAES00121339 1
0170888 06/01/2001 TX 1.0 1 .0 M 05/30/2001 Fever Roseola -Information has been received from a licensed visiting nurse concerning a 12 month old hispanic male with no known allergies, no known birth defects, no known medical conditions, and otitis media diagnosed on 17 Nov 2000 at the time of vaccination who on 15 Nov 2000 in the morning was vaccinated SC in the right arm with a first dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation lot 631639.0109k. The patient was also vaccinated with a first dose of varicella virus vaccine live MSD lot # 636356/0531k given sc in the left arm and the fourth dose of hib conjugate vaccine lot 560903a given im in the right thigh. On 18 Nov 2000 the patient developed a fever greater than 102 degrees. On 20 Nov 2000 when the fever susided the patient developed a red macular papular rash on his abdomen and lower back which spread to his entire body, except for his palms face and sides, consistent with roseola. Subseqently, the patient recovered from his experiences. No further details were reported. Y 11/15/2000 11/18/2000 3 PVT OTH otitis media NONE WAES00121454 1
0170889 06/01/2001 CO F 05/30/2001 Rash - Information has been received from a licensed practical nurse concerning an adult female who was vaccinated with measles virus vaccine live (+) umps virus vaccine live (+) rubella virus vaccine live second generation. The licensed practical nurse reported that the date of administration of the vaccine was unknown and 10 days later the patient presented with a mild rash. Unspecified medical attention was sought. In follow up the reporter stated. This patient was not treated in our clinic. we do not have any additional information. No further information is available. Y U UNK UNK unk unk WAES00121735 1
0170890 06/01/2001 PA 1.0 1 .0 M 05/30/2001 Rash - Information has been received from a licensed practical nurse concerning a 12 month old caucasian male who on 07 Dec 2000 was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation 633822/1268K o.5 ml intramuscularly on left leg. Concomitant therapy included amoxicillin trihydrate (+) clavulanate potassium augmentin. The licensed practical nurse reported that on 15 Dec 2000. the patient developed a rash that covered his whole body and face. in follow up the licensed practical nurse reported that the patient developed a rash on his stomach, back and face, which started on 15 Dec 2000. The licensed practical nurse reported that the patient was in the office on 18 Dec 2000 and the rash was all over body. she reported that the patient subsequently recovered from his experience. No further information is available. Y Y 12/07/2000 12/15/2000 8 PUB PUB Augmentin UNK WAES00121753 1
0170892 06/01/2001 IN 5.0 F 05/30/2001 Fever; akathisia, headache, injection site erythema, injection site swelling - Information has been received from a registered nurse concerning a 5 year old female who on 02 May 2000 was vaccinated IM with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation (lot 632457/1804J. On 02 May 2000 the patient was also vacinted IM with poliovirus vaccine lot #R0397 and im with a fifth dose of diphtheria toxoid / pertussie vaccine/teta acel-imune lot 467-011. On 02 May 2000 within five to seven hours, the patient developed a fever, headache, restlessness that night and an injection site reaction characterized by redness and swelling. No further details were provided. Additional information has been requested. U 05/02/2000 05/02/2000 0 UNK UNK UNK WAES00121973 1
0170897 06/01/2001 NY 1.08 1 .1 F 05/30/2001 Urticaria, Skin erythema- Information has been received from a physician concerning a 13 month old caucasian female, who on 22 Dec 2000, was vaccinated with a first dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation 635280/0579K in the left thigh. At the time of vaccination, the patient had benign neutropenia. Concomitant vaccination included poliovirus vaccine ipol and streptococcus pneumonia vaccine prevnar. Y Y 12/22/2000 12/23/2000 1 PVT PVT sodium fluoride (+) vitamins neutropenia UNK WAES00122108 1
0170898 06/01/2001 IN 0.2 0 .1 M 05/30/2001 Irritability - Information has been received from a medical assistant concerning a 2 month old caucasian male, who on 28 Dec 2000 was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation 631049/0105k intramuscularly. Concomitant therapy included hepatits b vaccine recombinant MSD 637547/1373k diphtheria thoxoid (+) haemophilus b conjugate vaccine (+) pertussia vaccine (+) tetanus toxoid tetramune vaccine lot 472-251. poliovirus vaccine ipol lot 70472 and hib conjugate vaccine hibtiter lot 570403A. Subsequently the patient experienced temorary fussiness. Unspecified medical attention was sought. Additional information is not expected Y U 12/28/2000 UNK UNK UNK WAES00122228 1
0170899 06/01/2001 NC 2.0 U 05/30/2001 Mumps - Information has been received from a registered nurse concerning a 2 year old patient who was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation at thirteen months of age. On 11 Dec 2000 the patient had lab confirmed diagosis of mumps. according to the nurse, the child failed to seroconvert. unspecified medical attention was sought for the child. additional information has been requested. Y U 12/11/2000 diagnostic laboratory normal range - , comments lab confirmed case of mumps UNK UNK UNK UNk WAES01010218 1
0170900 06/01/2001 MI 30.0 30 F 05/30/2002 Information has been received from a physician concerning a 30 year old female with no known drug allergies who on 28 Dec 2000 was vaccinated with MMRII(Lot #637255/1380K) SC. It was reported on 01/09/01, the "last night" the patient started developing some discomfort of her ears, particularly the right ear. On the morning of 01/09/01, the patient started experiencing some diccomfort of the left ear. The patient used Q-tips and there was some significant discharge on the tip. The patient had awareness, a discomfort, of both ears and she noticed some lumps particularly on the right posterior cervical area. The patient denied any sore throat, runny nose, shortness of breath, or any coughing. The patient did have a couple of papillar lesions on her skin and perhaps a little itchiness. The patient took acetaminophen (Tylenol Regular Strength) without any relief. The patient denied fevers and chills. The patient's blood pressure was 120/70, pulse was 68, weight 200 and temperature 37.2 C. The HEENT was essentially negative. The patient did have some erythema in the posterior pharyngeal area and a small definite mobile firm lymph node approximately .5 cm in diameter at the angle of the jaw on the right side. The patient also had what appeared to be two lymph nodes approximately 1 cm in diameter behind the right ear. They were almost confluent and she had one behind her left ear. There was fluid in both ears and her lungs were clear. The physician's reported impression was cervical adenopathy, bilateral serous otitis media, erythematous pharynx without any other symptoms. The physician reported that the symptoms were "probably related to viral infection." The physician was concerned enough about the adenopathy that it was "important for her to follow-up with her own PCP." The patient sought unspecified medical attention. No further information is expected. Y U 12/28/2000 01/08/2001 11 BP - 01/09/01 - 120/70, ENT -01/09/01 -essentially negative except she did not have some erythma in the posterior pharyngeal area, ENT -01/09/01 -small definite mobile firm lymph node - .5 centimeter in diameter at the angle of jaw right side, ENT -01/09/01- one small lymph node behind left ear, Physical examination -68 pulse, physical examination 01/09/01 - 14 -respiratory rate, ENT - 01/09/01 -Fluid in both ears and lungs were clear, ENT - 01/09/01 - Two lymph nodes -1 cm in diameter behind the right ear, Body Temperature -01/09/01 -37.2 C. OTH OTH UNK NKA WAES01010706 1
0170901 06/01/2001 1.08 1 .1 F 05/30/2001 Otitis- Information has been received from a consumer concerning her 13 month old female grandaughter with an allergy to penicillin who on 04 Jan 2001 was vaccinated with one dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation. Concomitant medication included zithromycin (zithromax). The night of post vaccination the patient was tugging at her ear and was noted to have an ear infection. The patient visited a medical doctor the following day. Additonal information has been requested. Y U 01/04/2001 01/04/2001 0 OTH OTH zithromax concurrent conditions; penicillin allergy WAES01010830 1
0170902 06/01/2001 PA 43.0 F 05/30/2001 Fever; Choking; chest pain; Injection site induration; malaise; injection site erythema; dyspnea - Information has been received from Wyeth-Lederle for pneumotoccal vaccine 23 polyvalent (Pnu-imune) and assigned manufacturer control number HQ768204Oct2000. The report concerned a 43 year old female with herpes simplex, who on approximately 01 Sep 2000 was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation lot 635466/0782k. On 06-Sep 2000 the patient was also vaccinated with pneumococcal vaccine 23 polyvalent (pnu-imune 23) lot #463-015). On 07-sep-2000, approximately 24 hours post vaccination, the patient developed an injection site reaction characterized by redness and induration. She also developed a fever of 101 degrees F that lasted for 1 to 2 days; then a fever of 99 to 100 degrees F. She also experienced malaise, shortness of breath, a choking sensation and chest tightness. The reporter stated that the injection site reaction had resolved, but the other events were ongoing at a lesser degree. The physician felt that these events may be related to an injection of measles-mumps-rubella vaccine that the patient had received one week earlier. This information was originally received from a physician. N 09/01/2000 09/07/2000 6 PVT OTH concurrent condition; herpes simplex WAES01010921 1
0170903 06/01/2001 IL 1.25 M 05/30/2001 Fever, Vomiting- Information has been received from Wyeth-Ayerst Research concerning streptococcus pneumoniae vaccine (prevnar) and assigned manufacturer control number HQ1662902Oct2000. The report concerned a 15 month old male, who on 27 Sept 2000, was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation route, site and lot number unknown. Concomitant therapy included the first dose of streptococcus pneumonia vaccine (prevnar) administered IM lot number unknown and HIB conjugate vaccine manufacturer and lot number unknown. On 27 Sep 2000, that day, thepatient developed a fever of 102.3 degrees F. and had one large vomiting episode. as of 28 Sep 2000 the patients fever of 102.3 degrees F. presisted. The physician also noted that he was concerned about the fever that his son developed post vaccination with streptococcus pneumonia vaccine and not the measles virus live - mumps virus vaccine live rubella virus vaccinelive second generation. This information was originally received from a physician, the father of the patient. N 09/27/2000 09/27/2000 0 OTH OTH UNK WAES01010933 1
0170905 06/01/2001 MN 1.3 1 .3 M 05/30/2001 Fever; Chills; Tremor; vomiting- Information has been received from Wyeth-Ayerst Research, MCN: Ho5182521Dec2000, regarding the patient concerned, a 15 month old caucasian male, with an unspecified drug hypersensitivity, was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation 0.5 ml subsutaneously on 11 OCT 1996. In the evening that day, the baby experienced fever, emesis and shakinese. In follow up, the nurse reported that the baby experienced and episode of chills, shaking, and emesis, The nurse noted that the patient's father had reported, on 28 July 2000, that his family was frightened. A neighbor who was a nurse was called to come over. No treatment was necessary and the situation resolved. The baby was ok the next day. No definite seizure was identified. No further details was provided. Y 10/11/1996 10/11/1996 0 UNK UNK unk concurrent condition: drug allergy WAES01010973 1
0170906 06/01/2001 TX U 05/30/2001 Measles- Information has been received from a physician concerning a patient who was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation. Subsequently the patient experienced incidences of breakthrough measles. Additional information has been requested. U UNK UNK unk unk WAES01011033 1
0170907 06/01/2001 1.25 U 05/30/2001 Urticaria - Information has been received from a physician concerning a 15 month old patient with on known allergies, who in approximately April 2000, was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation. About three hours after the vaccination, the patient developed diffuse hives which were sucessfully treated with diphenhydramine HCL benadryl without complication. The physician tested the child to see if the child had an egg sensitivity which was negative. The physician wanted to test the child for the anti-gelatin antibody. The patient wanted to have the patient tested for a gelatin hypersensitivity reaction. Subsequently, the patient recovered from diffuse hives. Additional information has been requested. Y Y 04/01/2000 04/04/2000 3 allergy test , normal range (-), comment negative egg sensitivity UNK UNK unk unk WAES01011191 1
0170908 06/01/2001 PA 3.0 3 M 05/30/2001 Ten days post vax, the pt developed a fine rash all over his body from measles virus vax live, mumps virus vax live, and rubella virus vax live. No other symptoms were reported. The pt sought unspecified medical attention and recovered. Additional information has been requested. Y Y 12/29/2000 01/09/2001 11 OTH OTH NONE UNK WAES01011418 1
0170909 06/01/2001 GA 30.0 M 05/30/2001 Fever, Nausea, Vomiting - Information has been received from a registered nurse concerning a 30 year old male, who was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation 635921/1181K. Subsequently, the patient experiened elevated temperature, nauses and vomiting. unspecified medical attention was sought. The patient recovered from elevated temperature, nauses and vomiting. Additional information has been requested. Y Y UNK UNK unk unk WAES01011821 1
0170910 06/01/2001 OH 1.0 1 .0 F 05/30/2001 Eczematous Dermatitis- Information has been received from a registered nurse concerning a 12 month Asian female, who on 12 Jan 2001, was vaccinated with measles virus vaccine live (+) mumps virus vacine live (+) rubella virus vaccine live second generation lot 1276 invalid. subcutaneously in the right thigh. At the time of vaccination the patient has otitis media and was treated with hydrocortisone (+) neomycin sulfate (+) polymxin B sulfate cortisporin otic solution. On 12 Jan 2001, the patient also was vaccinated with hepatitis b vaccine manufacturer unknown. On 19 Jan 2001, while at day care. the patient developed a mild rash on the back of her neck. The child was sent home due to possible contagiousness. The patient was seen by her physician who diagnosed eczema. The nurses reported she received information that this was not likely contagious. The patient recovered from the eczema. No further information is expected. Y Y 01/12/2001 01/19/2001 7 PVT PVT cortisporin otic solution otitis media UNK WAES01011831 1
0170911 06/01/2001 GA 36.0 M 05/30/2001 Fever, laryngitis,malaise,rash - information has been received from a registered nurse concerning a 36 year old male, who was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation 635921/1181k. Subsequently, the patient experience a mile rash, fever, general malaisa and laryngitis. Unspecified medical attention was sought. The patient recovered from a mile rash, fever, genral malaise and laryngitis. Y Y UNK UNK unk UNK WAES01011940 1
0170912 06/01/2001 GA 30.0 F 05/30/2001 Influenza - like disease - Information has been received from a registered nurse concerning a 30 year old female, who was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation 635921/1181k. subsequently, the patient experienced flu - like symptoms. Unspecified medical attention was sought. The patient recovered from the flu-like symptoms. Additional information has been requested. Y Y UNK UNK unk WAES01011941 1
0170913 06/01/2001 GA 42.0 M 05/30/2001 Rash; Pruritus; urticaria - information has been received from a registered nurse concerning a 42 year old male, who was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation 636921/1181k. Subsequently, the patient experienced a rash on both legs (inner calves), with welts and itching which lasted 7 days. Unspecified medical attention was sought. Subsequently, the patient recovered from the rash, welts, and itching Y Y UNK UNK unk WAES01011942 1
0170914 06/01/2001 U 05/30/2001 Raynaud's Phenomenon; Nervous condition, paresthesia - information has been received from a company representative concerning a patient who was vaccinated with one dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live . On 17 Jan 2001 the reporter states that the doctor was to see a consult patient who on an unspecified day developed nervous ticks, pareathesia and Raynaud's phenomanon type problem in fingers and toes. It was noted that the onset of the patient's symptoms was claimed to be after vaccination. additional information has been requested. Y OTH OTH unk unk WAES01012174 1
0170915 06/01/2001 TX 5.0 5 M 05/30/2001 Fever - Information has been received from a health professional concerning her 5 year old male nephew with a history of attention deficit disorder and allergies to methylphenidate HCL ritalin and dextroamphetamine - amphetamine asparate - amphetamine sulfate - adderall. The patient was vaccinated with his first and second dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation before his first birthday in approximately 1995. He received the third dose between October 2000 and Decoember 2000. The reporter stated that twelve days after receiving his third vaccination her nephew had a fever of 104 degrees fahrenhelt. The patient did not receive medical attention. The school district wanted the child to receive a fourth dose. F/U 6/19/02 indicated that the pt was vaccinated with the 3rd dose of MMRII in 12/00. There was no illness at the time of vaccination. About 14 days after the injection on 12/26/00, he developed a temperature of 104F. The physician was called and since the pt had "no other symptoms of a URI, etc, the temperature was attributed to the MMR". It was reported that the pt required a doctor visit. The school district wanted the child to receive a 4th dose, however the dose was never given. Additional info has been requested. Y U 12/12/2000 12/26/2000 14 Body temp-12/26/01-104F UNK UNK unk concurrent conditions; attention deficit disorder without hyperactivity; drug allergy to Ritalin and Adderall. WAES01012233 1
0170916 06/01/2001 IL 36.0 36 F 05/30/2001 Injection site mass, pain, warm sensation - Information has been received from a registered nurse concerning a 36 year old African American female who on 08-Jan 2001 was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation booster dose 633817/0172k subcutaneously in the left arm. The registered nurse reported that the patient returned on 26 Jan 2001 and told the nurse that her arm was warm and had a small bump in her arm where the injection was given. In follow up the registered nurse reported that the patient's arm is warm tender to touch, small egg size lump present at site where given. The nurse reported that one week later it is much improved, mass decreased in size and patient denies complaints. The registered nurse reported that the patient recovered. No further information is available. Y Y 01/08/2001 01/26/2001 18 UNK UNK unk WAES01012500 1
0170917 06/01/2001 MO M 05/30/2001 Rash - Information has been received from a health professional concerning a male who was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation in his left leg lot 633819/0992k. Aproximately 10-11 days after the vaccination the patient developed a maculopapular rash on his neck, chest and trunk. N OTH OTH unk WAES01012505 1
0170918 06/01/2001 NJ 29.0 F 05/30/2001 Lack of Response - Information has been received from a physicain concerning a 29 year old female who, years ago, was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation. She received a second dose in January 2000. Sebsequently the patient had titers drawn and rubeola came back questionable. U 01/01/2000 test: diagnostic laboratory, normal range: -, comment: rubeola titer questionable OTH OTH unk unk WAES01012707 1
0170919 06/01/2001 8.0 8 F 05/30/2002 Information has been received from a registered nurse concerning an 8 year old female on 08/22/95 (received at different facility) and 01/12/01 was vaccinated with MMRII. On approximately 01/14/01, the patient developed a "rash" and a fever. the patient was diagnosed, The patient's mother informed the nurse that a physician later told her that the rash was not related to the immuniozation. The patient gabe the nurse a note from a physican stating the patient had a lab-confirmed case of measles. The patient had a rash and was generally "not well" feeling. The patient's sister experienced a similar event after vaccination with MMRII (WAES01040482). In follow-up, the nurse reported that on 11/24/01, arubella titer "resulted as immune". Additional information has been requested. Y U 01/12/2001 01/31/2001 19 (Procedure unspecified) - measles pending, Diagnostic Laboratory - 11/26/2001 -rubella titer positive, UNK UNK unk ~Measles + Rubella (MR-Vax II)~2~5.00~In Sibling|~Measles + Rubella (MR-Vax II)~2~5.00~In Sibling WAES01020020 1
0170920 06/01/2001 CA 1.5 M 05/30/2001 Injection site wheal - Information has been received from a health professional concerning an 18 month old male with an allergy to eggs who was vaccinated in October 2000 with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation. The injection site started to develop a wheal and the doctor did not inject the entire dose. Unspecified medical attention was sought. The reaction resolved within 24 hours. Y Y 10/01/2000 10/01/2000 0 UNK UNK UNK eggs allergy unk WAES01020055 1
0170921 06/01/2001 1.2 1 .2 F 05/30/2002 Information has been received from a registered nurse concerning a 14 month old patient who on 01/12/01 was vaccinated with MMRII. Concomitant therapy included amoxicillin (dose, duration and indication not reported) which was being taken for the first time. On 01/12/01, the patient developed cold symptoms. On 01/16/01, the patient developed a rash which started on the buttocks and spread to the back and then covered most of the body. Amoxicillin was discontinued when the patient developed the rash. On 01/24/01, the patient still had the rash and went to the emergency room with the rash and a fever. On 01/25/01, the patient was given diphenhydramine (Benadryl) which did not help to relieve the rash. On 01/26/01, the patient went back to the emergency room with the rash and IGM was 640. The nurse noted that as per the lab, anything over 10 would be positive for measles. The nurse also noted that there were two other confirmed measles cases in their area and she was not sure if the patient had contact with the other two cases. No further details were provided. Additional information has been requested. Y U 01/12/2001 01/14/2001 2 test- serum immunoglobulin M 01/26/01 value unit 640 OTH OTH amoxicillin NKA WAES01020204 1
0170922 06/01/2001 TN 1 .9 F 05/30/2001 viral exanthema, anthralgia - information has been received from a physician concerning a female with no known drug allergies who at 15 month of age, in 1998, was vaccined with her first dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation. The physician reported that two weeks after the vaccination the patien developed a red viral rash with joint pain. The patient did not seek medial attention. In follow up the physician reported the patien was seeing another physician at the time of her 15 month mmr. he reported, she now comes to me and is currently 5 years old. i called because of the history or reaction three years ago at another physician's office. U 01/01/1998 01/01/1998 0 OTH OTH unk unk WAES01020535 1
0170923 06/01/2001 NY 16.0 F 05/30/2001 Fever - Information has been received from a physician concerning a 16 year old female, who was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation lot # not available while living in another country and developed a fever post - immunization. The date of the immunization was unknown. The physician reported that information was very limited an in Spanish. No futher information is available. U UNK UNK unk unk WAES01020650 1
0170924 06/01/2001 TN 1.25 F 05/30/2002 Information has been receiver from a consumer concerning a female family member, a child who on an unspecified date was vaccinated with MMRII. It was reported that the patient age 5 years at the time of the report was vaccinated at 15 month of age. The patient developed a mealse like rash for about ten days after her vaccination with MMRII. She also developed a fever for approximately five days. Subsequently the patient recovered. The patient sought unspecified medical attention. Additional information has been requested. Y Y OTH OTH UNK NKA WAES01020657 1
0170925 06/01/2001 KS 22.0 21 F 05/30/2001 lack of response - information has been received from a health professional concerning a 22 year old female employee who on 16 jun 2000 was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation lot 633595/1658J. On 24 Aug 2000 the patient received a second vaccination with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation lot 632456/0173k. On 30 jan 2001 the patients titer was drawn and the titer was negative for measles. additonal information has been requested. U 08/24/2000 01/30/2001 159 diagnostic laboratory 01/30/2001 normal range - , comments negative titer for mealses. OTH OTH unk unk WAES01021103 1
0170926 06/01/2001 TX 1.0 1 .1 M 05/30/2001 Fever, Rash - Information has been received from a health professional concerning a 12 month old male with who was born primaturely, who on 22 Jan 2001, was vaccinated with the first dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation 0.5 mg sc in the right arm lot # 633822/1168k and the first dose of varicella virus vaccine live lot # 636357/0532k 0.5 ml sc in the left arm. On 22 jan 2001. the patient was also vaccinated with the fourth dose of hib conjugate vaccine o.5 ml im in the rights thigh lot 58133a. On 02 feb 2001, the patient was seen secondary to red rash that was present for one day. The rash started on abdomen, spread to chest, diaper area, back, up & down extremitives, face, and neck. The patient's palms and soles were spared. The rash consisted of small discrete red papules, without vesicles or pustules. On threee days prior to devlopment of rash on 30 Jan 2001, the patient developed a fever for 3 days. subsequently, the patient recovered. Additional information has been requested. Y Y 01/22/2001 01/30/2001 8 PVT UNK medical history; prematurity WAES01021153 1
0170927 06/01/2001 PA 1.08 1 .1 F 05/30/2001 Information has been received from a health professional concerning a 13 month old female who on 02/01/01 was vaccinated with the first dose of MMRII (lot #636659/0997K) in the left arm. On 02/12/01, the patient developed a red rash on her abdomen, chest, back, neck and face. On the following day, 02/13/01, she was seen by a physician and the rash was over the entire body and face. The patient was ordered diphenhydramine (Benadryl) for itching as needed. The diagnosis was measles rash related to therapy with MMRII. It was reported that the patient recovered. No additional information is expected. Y Y 02/01/2001 02/12/2001 11 PVT OTH UNK NKA WAES01021191 1
0170928 06/01/2001 AZ 1.0 1 .0 F 05/30/2001 vomiting - Information has been received from a consumer concerning her 12 month old female daughter who on 02 feb 2001 was vaccinated with one dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation. Concomitant therapy included one dose of heamophilus b conjugate vaccine manufacturer unknown. Other concomitant therapy that day included one dose of paliovirus vaccine and one dose of diphtheria toxoid/pertuesia vaccine/teta, On 15 Feb 2001 at 4:00 am the patient began vomiting. The mother reported that her brother had a seizure after receiving measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation waes 01021357. The patient received unspecified medical attention. Additonal information has been requested. Y U 02/02/2001 02/15/2001 13 OTH OTH unk WAES01021270 1
0170929 06/01/2001 RI 1.5 M 05/30/2001 Injection site reaction - Information has been received from a dermatiologist's office concerning an 16 month old male who was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation. subsequently the patient experienced a large reaction around the injection site. It was reported that the circular pattern around the injection site was at least 6cm. in diameter. It was indicated that the dermatologist received this information from the patient's mother. No other information was available at this time. unspecified medical attention was sought. Additional information has been requested. Y U OTH OTH unk unk WAES01021558 1
0170930 06/01/2001 U 05/30/2002 Information has been received from a health profesional concerning "two patients" who were vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation. Subsequently the patient did not show seroconversion. The nurse had no further patient information. Unspecified medical attention was sought. Additonal Information has been requested. FOLLOW UP Information has been received from a registered nurse who states the vaccinations were not given at her office. She reports that there is no way for her to obtain the lot numbers for the vaccine administered. No further information is expected. Y U Diagnostic Laboratory -no OTH OTH UNK NKA WAES01021833 1
0170931 06/01/2001 OK 54.0 F 05/30/2001 Morsilliform rash, arthralgia, malaise - Information has been received from a physician concerning a 54 year old female who on 14 feb 2001 was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation lot 635917/0825K. On 26 Feb 2001 the patient experienced a mealses like rash on her trunk arms, thighs, and face that was described as red blotchy spots. The patient also reported joint pain and general malaise. It was indicated that the patient did not have a fever. Unspecified medical attention was sought. No further information was provided. Additonal information has been requested. Y U 02/14/2001 02/26/2001 12 OTH OTH unk unk WAES01030027 1
0170932 06/01/2001 IN 1.0 0 1 F 05/30/2001 Thrombocytopenia - Information has been received from a health care professional concerning an approximately 12 month old female who in Feb 1991 was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation. It was reported that the patient experienced thrombocytopenia a short time later. unspecified medical attention was sought. No other information was available. Follow up on 08/09/02: "Follow up information has been received from a health professional who states the pt "did not have the reaction in our practice." She reports that there is no way for them to obtain additional information . No further information is expected." Y U 02/01/1991 02/01/1991 0 OTH OTH unk unk WAES01030124 1
0170933 06/01/2001 F 05/30/2001 Measles - Information has been received from a company representative concerning her niece, who was vaccinated with mealses virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation at one year of age. subsequently, the patient was later diagnosed with a mild case of measles and is doing fine. Additional information has been requested. Y U UNK UNK unk unk WAES01030245 1
0170934 06/01/2001 1.08 1 .1 F 05/30/2001 Rash - Information has been received from a physician concerning her 13 month old daughter with no known drug allergies and no past medical history who on 15 Feb 2001 was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation. Concomitant therapy included varicella virus vaccine live MSD. On 27 Feb 2001 the patient experienced a red rash on her abdomen and back and for the next few days she had macules head to toe. It was reported that the rash on her face is starting to fade. Unspecified medical attention was sought. Additonal information has been requested. Y N 02/15/2001 02/27/2001 12 OTH OTH NONe WAES01030256 1
0170935 06/01/2001 14.0 F 05/30/2002 Information has been received from a health professional concerning a 14 year old female who was vaccinated with a series of three mealses virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation immunization. Subsequently the patient had a negative titer. Unspecified medical attention was sought. Attempt to obtain lot number have been unsuccessful Additional information has been requested. Y U diagnostic laboratory - (-) mmr titer OTH OTH UNK NKA WAES01030296 1
0170937 06/01/2001 NJ 1 .3 F 05/30/2001 Rash, Fever - Information has been received from a health care professional concerning a female who on 10 Jun 1999 was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation lot 618391/0890D. Subsequently the patient experienced a red, blotchy rash all over her body and a fever. follow up information has been received from a physician who stated this matter has been resolved. The patients reaction was to the measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live which was given 6-10-1997. Y 06/10/1997 OTH OTH unk unk WAES01030904 1
0170938 06/01/2001 VA 1.2 1 .1 F 05/30/2001 Rash, Cough - Information has been received from a pharmacist concerning a 14 month old female relative, with no known allergies and a history of heart murmur. who on 22 feb 2001, was vaccinated with mealses virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation lot 630638/0140k. On approximately 02 Mar 2001 the patient developed a servers hacking cough. On 07 Mar 2001 the patient developed a total body rash. U 02/22/2001 03/02/2001 8 OTH OTH unk medical history- cardiac murmur WAES01030917 1
0170939 06/01/2001 IN 1.02 1 .2 M 05/30/2001 Rash, fever - Information has been received from a health professional concerning a 14 month old male, with no known drug allergies. who on 26 Feb 2001 was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation lot 635125/0400k. Concomitant vaccines included one dose of varicella virus vaccine live MSD lot 635980/0446k and hib conj-hepatitis b vaccine MSD lot 636992/1174k. On 09 Mar 2001 the patient developed a red rash, without blisters or lesions, on her abdomen and neck and low grade fever. U 02/26/2001 03/09/2001 11 UNK UNK unk WAES01031017 1
0170940 06/01/2001 NY 1.25 1 .3 M 05/30/2002 On 08/30/98, the patient developed a fever of 103 degrees F and a slight rash on his legs. The event required a doctor visit. the patient recovered. Additional information has been requested. Y Y 08/20/1998 08/29/1998 9 Body Temperature - 08/29/98 -105 F PVT PVT UNK NONE WAES01031021 1
0170941 06/01/2001 SC 1.0 U 05/30/2001 morbilliform rash - information has been received from a physician concerning a 1 year old patient who was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation lot 633570/1655j and the varicella virus vaccine live msd lot 634846/0933k. the physician reported that 8 days post vaccination the patient developed a mealses like rash. U UNK UNK unk WAES01031025 1
0170942 06/01/2001 FL 47.0 F 05/30/2001 Rash - Information has been received from a doctor of pharmacy concerning a 47 year old female who on 22 Jan 2001 was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation 632048/0105k. On 08 Feb 2001 the patient experienced red rash. The patient sought medical attention. The reporter noted that another woman received a vaccine dose from the same lot # and experienced a red rash waes 01031396. Y U 01/22/2001 02/08/2001 17 OTH OTH unk WAES01031028 1
0170943 06/01/2001 WI 1.25 1 .2 F 05/30/2002 Fever; irritability; morbilliform rash - Information has been received from a pharmacist concerning her 15 month old white daughter who on 21 feb 2001 was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation lot 636657/1160k. On 03/02/01 the patient developed a fever and irritability through to 05 mar 2001. She was treated with acetaminophen tylenol. On 06- Mar 2001 the patient developed a non pruritic generalized rash on her trunk, front and back, which spread to her extremities and under her hairline. The rash had the appearance of a classic measles rash. A physician office note describes the rash as a morbilliform rash on the trunk and proximal upper extremity, not on the lower extremities. There was also some confluent rash behind both ears, and her cheeks were pink. There was no lace like appearance, the rash did not feel rough or sandpapery. There was no axillary, supreclavicular or abdominal adenopathy. On 14 mar 2001 he rash resolved and the patient recovered. No further details were provided. The pharmacist also reported that another child at the same clinic as her daughter, developed the same rash and a fever after receiving measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation lot 636657/1160k waes 010408383. No further information is available Y Y 02/21/2001 03/02/2001 9 PVT PUB unk NKA WAEs01031049 1
0170944 06/01/2001 FL 45.0 F 05/30/2001 Rash - Information has been received from a doctor of pharmacy concerning a 45 year old female who on 08 Jan 2001 was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation 631048/0105k. On 22 Jan 2001 the patient experienced red rash. The patient sought medical attention. The reporter noted that another woman received a vaccine dose from the same lot number and experienced a red rash waes 01030128. Y U 01/08/2001 01/22/2001 14 OTH OTH unk WAES01031396 1
0170945 06/01/2001 OH 5.0 M 05/30/2001 Information has been received from from GlaxoSmithkline (2001006335-1) concerning a 5 year old male who on 03/05/01 was vaccinated with MMRII. On approximately 03/06/01, 1-2 days later, the patient experienced baseball-sized redness, pain and heat at the injection site. Medical attention was sought. As of 03/08/01,the patient's redness, pain and heat at the injection size persisted. Follow up information from a registered nurse indicated that after review of the patient's chart and confirmed that the baseball-size redness, pain and heat at the injection site in this case were associated with DTP (manufacturer unknown) and not MMRII (MSD) (lot # not available). The information was originally received from a registered nurse. Y N 03/05/2001 03/06/2001 1 PVT OTH unk NKA WAES01031419 1
0170946 06/01/2001 30.0 F 05/30/2002 Information has been received on 03/14/01, from a health professional concerning a 30 year old female who in March 2001 was vaccinate with one dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation. Concomitant therapy included hormonal contraceptives (unspecified). It was reported on 14 Mar 2001 that several days ago, 6-8 days post vaccination, the patient developed a small lesion on her left wrist. The patient sought medical attention. Follow up information was received from the same nurse pravtitioner who indicated that the patient's rash was not due to MMRII(MSD) (lot number not reported). The patient's rash recuurred and a diagnosis of Tinea was made. The reporter indicated the patient's symptoms were not related to MMRII (MSD). Additional information is not expected Y U 03/01/2001 03/01/2001 0 OTH OTH hormonal contraceptives. NKA WAES01031623 1
0170947 06/01/2001 NY U 05/30/2001 Lack of Response - Information has been received from a pharmacist concerning a patient who was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation. Subsequently the patient failed to sero convert. The patient was them administered a blooster dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation and still had no titers. Additional information has been requested. U UNK UNK unk WAES01032667 1
0170948 06/01/2001 MS M 05/30/2001 Asthenia / Fatigue, - Information has been received from a male consumer concerning his male grandson who in approximately January 2001. was vaccinated with measles virus vaccine live mumps virus vaccine live rubella virus vaccine live second generation. Immediately after the child's vaccination he became lethargic, very inactive and sleepy. subsequently the patient recovered. Additional information has been requested. Y 01/01/2001 01/01/2001 0 UNK UNK unk unk WAES01032917 1
0170949 06/01/2001 F 05/30/2001 cough, paresthesia - Information has been received from a physician concerning a female patient who in March 2001, was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation site not reported. In march 2001, the patient experienced a cough and tingling and burning sensation. No further information is available. N 03/01/2001 03/01/2001 0 UNK UNK unk unk WAES01033050 1
0170950 06/01/2001 MN 15.0 1 .3 F 05/30/2001 Injection site wheal, papule, urticaria - Information has been received from a registered nurse concerning a white 15 month old female with no known drug allergies who on 23 Mar 2001 was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vacine live second generation lot 637382/1509k. on 23 mar 2001, the child was also vaccinated with streptococcus phenuomia vaccine prevnar lot 472-332 and diphtheria toxid (+) haemophilus b conjugate vaccine (+) pertussia vaccine (+) tetanus toxoid trihibit lot us554aa and u031411. Within 10-15 minutes of receiving the measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation in her left subcutaneous area over the deltoid, the child developed a large erythamatous plaque with a contral wheal that was distinct from the actual injection site. She later developed a small hive on her vace and she had a few erythematous papules on her chest. the child was given diphenydramine benadryl 3/4 tsp and ice. She was observed for 30 -45 minutes in the clinic. Her lungs were clear, she remained active, no further lesions immerged, she was instructed to repeat diphenhydramine dose every 6 hours while awake on 23 mar 2001 and then discontinue, she recovered from the events, no further details were provided. The patient sister waes 01033066 had a similar experience. Y 03/23/2001 03/23/2001 0 OTH OTH unk WAES01033060 1
0170951 06/01/2001 MN 1.25 1 .3 F 05/30/2002 Information has been received from a registered nurse concerning a white 15 month old female with no known drug allergies who on 02/23/01 at 10:00 AM was vaccinated with MMRII (Lot 537382/1509K)SC in the left arm. concomitant vaccinations on the same day included the first dose of Streptococcus pneumoniae vaccine (Prevnar) (Lot # 473-332) IM in the left thigh and the fourth dose of diptheria toxoid(+) haemophilusBconjugate vaccine (+) pertussis vaccine(+) tetanus toxoids (TriHibit) Lot # UA554AA and UO341AA) IM in the right thigh. On 03/23/02, within 15 minutes of the injection with MMRII, the patient developed a 1 cm hive with an area of red plaque with a central white wheel. She had no other hive lesions develop. The child was given diphenhyramine (Benadryl) 3/4 tsp and ice. She was observed in the clinic for an additional 30 minutes without further reaction. The mother was given instructions to give diphenhyramine same dose every 6 hours while awake on 03/23/01 and then discontinue. The patient recovered from the event. The patient's sister (WAES#01033060) had a similar experience. No further details were provided. Y 03/23/2001 03/23/2001 0 PVT PVT NKA ~Measles + Mumps + Rubella (MMR II)~1~1.25~In Sibling|~Measles + Mumps + Rubella (MMR II)~1~1.25~In Sibling WAES01033066 1
0170952 06/01/2001 OH F 05/30/2002 Information has been received from a health provessional concerning a female consumer with an amoxicillin allergy who on 02/08/01 was vaccinated with MMRII 0.5 ml IM (Lot 628755/1147J). There was no concomitant medication. On 03/26/01 the patient complained of swelling pain and discomfort at the injection site. Follow-up information from the same LNP indicated that the patient was administered the vaccine IM in the deltoid instead of SC and C/O a sore arm. The patient subsequently recovered from her sore arm. Additional information is not expected. Y 02/28/2001 03/26/2001 26 PVT OTH none concurrent condition- amoxicillin allergy WAES01038198 1
0170953 06/01/2001 VA U 05/30/2001 Fever - Information has been received from a physician concerning 4 patients who in march 2001 were vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation lot 637423/1512k. In march 2001, the patient experienced high fever or greater than 102F. unspecified medical attention was sought. additional information has been requested. Y U 03/01/2001 03/01/2001 0 test: temperature measurement, date: 03/01/01, value: >102f OTH OTH UNk UNk WAES01033201 1
0170954 06/01/2001 GA F 05/30/2001 fever, arthralgia,lymphadenopathy - Information has been received from a physician concerning her sister (nurse practitioner) who in early december 1994, was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation. After two to three weeks, the patient developed a low grade fever, lymphadenopathy and arthralgia. The physician reported that she feels the vaccine virus may have been transmitted to her (waes# 01033343) (also reported as transmission of rubella from this vaccinated individual). No further detail were provide. On follow-up the physician reported that her sister developed lymphadenopathy, polyarthritis and low grade fever after vaccination. No further details were provided. Y U 12/01/1994 12/15/1994 14 OTH OTH Unknown Unknown WAES#01033343 1
0170955 06/01/2001 FL 41.0 F 05/30/2001 Secondary transmission; bronchitis; fever; lymphadenopathy; tinnitus; sinusitis; rash; ostroarthritis - Information has been received from a 41 year old female physician, born 21 Jan 1953 with no known drug allergies and hypothyroidism whose sister was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation in early december 1994. The sister experienced a low grad fever. Lymphadenopathy and arthritis two to three weeks after the vaccination waes# 01033214. The physician visited her sister during the third week post vaccination and felt that the vaccine virus may have been transmitted to her at that time. Concomitant therapy included levothyroxine sodium (synthroid). On 20 jan 1995 the physician experienced a low grade fever, macular rash, lymphadenopathy, sinusitis, bronchitis and diffuse arthritis, which was the worst in her right knee. The sisusitis and bronchitis were treated with azithromycin (Zithromax). The physician noted that most symptoms resolved within a month or two however, the arthritis pain continued and the following summer she developed tinnitus. both the tinnitus and the arthritis continued to the present. The physician had seen a rheumatologist and has since been diagnosed with osteoarthritis of the right knee, left elbow and lumbar sacral spine. no further details were provided. additional information has been requested. A 15-day follow up report received 4/19/2002 adds: Additional info from the physician indicated that she was reporting transmission of rubella from her vaccinated sister to her. Her sister developed lymphadenopathy, polyarthritis and low grade fever after vaccination with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) (WAES #01033214). The physician developed a fever to 103, lymphadenopathy, arthritis and bronchitis 3 weeks after contact with her vaccinated sister. She noted that she had severe rubella 01/23/1995 with a very high IgM for rubella. At the time of this report in May 2001, the physician still had post rubella arthritis of the right knee and severe tinnitus. She had recovered from the other events. The physician indicated that the arthritis and tinnitus were persistent disabilities/incapacities. No further details were provided. Y Y N 01/20/1995 OTH OTH synthoroid concurrent conditions; hypothyroidism WAES01033343 1
0170956 06/01/2001 0.5 0 .4 F 05/30/2001 Cough, fever, rash, Information has been received from a pharmacist concerning her 2 year old daughter with no known drug allergies who was vaccinated with two doses of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation by two different health care providers, the last in approximately 1999. it was noted that the doses were separated by several months and given due to a change in doctors and no available vaccination records. On approximately 13 mar 2001 the patient experienced a bronchitis like cough and on approximately 25 mar 2001 the patient experienced red rash over her entire body and fever of 103. unspecified medical attention was sought. No other information was available. Additional information has been requested. Y U 01/01/1999 03/13/2001 802 test: temperature measurement, date : 03/25/2001, value: 103f OTH OTH UNK UNK WAES01033355 1
0170957 06/01/2001 DE 20.0 F 05/30/2002 Information has been received from a consumer concerning her 20 year old white daughter with a non remarkable past medical history and no allegies who in 1981 and 1997 was vaccinated with a first and second dose of MMRII, respectively. There was no concomitant medication. The physician reported that the patient was seen in the office early in her pregnancy for obstetrical care and as part of the "standard of care" provided of all their pregnat patients, an early screening to determine the patient's Rubella Immunity Status was performed. On 03/14/01, laboratory results for rubella antibodies, IgG revealed a level of <5 (normal range 5 ->10), which indicated that the patient was non-immune to rubella. The patient did not receive the MMRII while she was pregnant. The physician noted that the plan was to give the patient a rubella vaccination. postpartum to restore her immunity. Additional information is not expected. Y U 03/27/2001 test: dianostic labortory - 03/27/2001, <5 - (5 - 10) - not immune rubellaAntibodies Ig G OTH OTH NONE concurrent conditions; pregnancy (lmp - unknown) WAES01033364 1
0170958 06/01/2001 GA 31.0 31 M 05/30/2001 Information has been received from a health professional concerning a 31 year old male with no past medical history and a penicillin allergy who on 22 mar 2001 was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation. concomitant therapy included hepatitis a vaccine Havrix and polivirus vaccine ipol. On 24 mar 2001 the patient experienced chills and malaise. On 03/26/01 the patient experienec hives on his forehead, chest and arms and itchy eyes. The patient was seen by a doctor and treated for conjuncitivitis and drug reaction. There was no information on the medication ordered. It was noted that the patient received measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live as a child. Follow Up information has been received from a health professional who reports that on 03/26/01 the patient had a rash on his face, chest and spread to his arms. The rash worsened over the course of one week. It was reported that his eyes itched and on 03/26/01 he had the chills for one day. The patient recovered on 04/01/01. Y U 03/22/2001 03/24/2001 2 PVT PUB concurrent conditions: penicillin allergy WAES01033366 1
0170959 06/01/2001 NC 1.4 1 .2 M 05/30/2001 Information has been received from a physician concerning a 17 month old male with no past medical history who on 08/06/99 was vaccinated with one dose of measles virus vaccine live (+) mumps virus vaccine live (+) ruebella virus vaccine live second generation. Concomitant vaccination that day included one dose of varicella virus vaccine live (MSD) one dose of Hastrophilium B conjugate vaccine (manufacuturer unknown) and one dose of diphtheria toxoid (+) pertussia vaccine (+) tetanus toxoid. It was reported on 21 Oct 1999 that the patient had an allergy to MMR. No further information is available. It was also reported that the patient developed adverse experiences after receiving varicella virus vaccine live (waes 00091032.) U 08/06/1999 10/21/1999 76 PVT PUB NKA WAES01042214 1
0170960 06/01/2001 MI 27.0 25 F 05/15/2001 Pre - Kclampsia, Anorectal Hemorrhage - Information has been received from a physician concerning a 27 year old female who on 18 Jan 2000 was vaccinated with one dose of varicella virus vaccine live ( site unknown) . Subsequently, the patient learned that she was pregnant. LMP 20 Dec 1999. This report is part of the pregnancy registry. Follow up revealed that the patient developed mild pre-eclampsia during labor but on 16 Sep 2000 a normal healthy baby girl was delivered vaginally. The baby has been seen since birth for rectal bleeding believed to be bacterial in origin and has since resolved. No other information is available. Y Y 01/18/2000 OTH OTH UNK Concurrent condition : pregnancy LMP 12-20-1999 WAES00021483 1
0170961 06/01/2001 IN 41.0 0 1 M 05/15/2001 Uaricella - Information has been received from a physician concerning a 41 month old Caucasian male patient who on 17 Sep 1007 was vaccinated IM in the left arm with a first dose of varicelle virus vaccine live lot 623125/0546E. There were no concurrent conditions or known drug allergies. On 12 Mar 2000 the patient broke out with chickenpox. On 13 Mar 2000 the patient's mother reported that the patient had less than 50 pox. It was noted that 7-10 days later, the patient recovered. No further information is expected. Y 09/17/1997 03/12/2000 907 PVT PVT UNK WAES00031849 1
0170962 06/01/2001 TX 4.0 1 .0 F 05/15/2001 Varicella - Information has been received from a registered nurse concerning a 4 year old Caucasin female patient who on 14 Jun 1995 was vaccinated with varicella virus vaccine live. On 07 Mar 2000 the patient presented with chickenpox that consisted of approximately 30 lesions. The patient was treated with oral diphenhydramine HCL (Benadryl) and calamine lotion. Subsequently, the patient recovered. Additional information has been requested. Y Y 06/14/1996 03/07/2000 1362 OTH OTH UNK WAES00031855 1
0170963 06/01/2001 MA 9.0 4 F 05/15/2001 Varicella - Information has been received from a licensed practical nurse concerning a 9 year old female patient who on 04 Jan 1996 was vaccinated SC with a first dose of varicella virus vaccine live (lot 508578/0389b). Subsequently the patient experienced chickenpox. It was noted that the patient had over 100 lesions. She was seen in the physician office to verify the actual number of lesions and the disease. Subsequently, the patient recovered. Additional information is not expected. Y Y 01/04/1995 OTH OTH UNK UNK WAES00031857 1
0170964 06/01/2001 TX 39.0 34 F 05/15/2001 Varicella - Information has been received from a consumer who is a healthcare professional. She is a 39 year old female who was vaccinated on 31 Mar 1996 and 22 Apr 1996 with one dose of varicella virus vaccine live from a family practice office Unknown site. The patient report that on 15 Jan 2000 she was exposed to a child with severe chicken pox who was covered with lesions and she performed strep test on child. On 20 jan 2000 the patient developed chicken pox approxiamtely 30 lesions. The patient reports that her 2 children who received varivax at the same time she did did not develop chicken pox. The patient reports that she did not see her family MD but saw the pediatrician she works with who treated her with Acyclovir. Y 04/22/1995 01/20/2000 1734 PVT OTH UNK Medical History: varicella exposure WAES00031906 1
0170965 06/01/2001 PA 3.0 1 .1 F 05/15/2001 Varicella - Information has been received from a healthcare professional concerning a 44 month old female who was vaccinated on 11 Jul 1997 with one dose of varicella virus vaccine live (unknown site) on 18 mar 2000 the patient developed lesions and on 20 mar 2000 the patient was diagnosed with chicken pox. the patient has 25-30 lesions on back, stomach, face, neck. the patient sought unknown medical attention. Y U 07/11/1997 03/18/2000 981 OTH OTH UNK UNK WAES00031926 1
0170966 06/01/2001 NC 4.0 1 .3 M 05/15/2001 Varicella - Information has been received from a male in an office concerning a 4 year old male who on 10 Mar 1007 was vaccinated with one dose of varicella virus vaccine live Lot 621191/1549d in the lateral left thigh. On 15 Mar 2000 the patient developed a mild form of chicken pox. The reporter stated the patient was not really that sick and unspecified date the patient recovered. Y Y 03/10/1997 03/15/2000 1101 PVT OTH UNK UNK WAES00031934 1
0170967 06/01/2001 OH 5.0 4 M 05/15/2001 Varicella - Information has been received from a healthcare professional concerning a 5 year old male with strep at the time of vaccination who on 09 aug 1999 was vaccinated sc with one dose of varicella virus vaccine live lot 630675/0424J in the left arm. Concomitant therapy included amoxicillin trihydrate (Amoxil). On 10 mar 2000 thepatient developed a feer of 102 degrees F. On 18 Mar 2000, he developed 3 pustules and one veasicle on his right cheek and chin. the patient was then afebrile. The patient sought unspecified medical attention. Follow up information received a healthcare professional indicated that the patient was seen in a physician's office on 20 mar 2000 and diagnosed with atypical varicella. on an unspecified date the patient recovered. No further information is available. Y Y 08/09/1999 03/18/2000 222 PVT PVT amoxil concurrent conditions: streptococcal pharyngitis WAES00031945 1
0170968 06/01/2001 NY 25.0 25 F 05/15/2001 Lack of Response - information has been received from a physician concerning a 25 year old female family member who was vaccinated in December. 1995 and January. 1996 with the first and second doses of varicella virus vaccine live (unspecified site) respectively. On 23 apr 1996, the patien had negative varicella antibody titers of less than 0.86 which indicates that the patient is not immune. the patient received unspecified medial attention. No further information is available. Y U 01/01/1996 04/23/1996 113 test : diagnostic laboratory, date : 04/23/96, value unit: <, Normal Range: > 0.99 - , comment: varicella zoster Ab, 10G test result = not immune. PVT OTH UNK UNK WAES00031949 1
0170969 06/01/2001 NJ 39.0 39 F 05/15/2001 Fever, Hypertension, influenza-like disease, nauses - Information has been received from a 39 year old caucasian female consumer with a penicillin allergy, cononary artery disease, asthma, hypertension and hyporlipidemia and a history of bypass surgery in 1998 who on 14 mar 2000 was vaccinated with varicella virus vaccine live. Concomitant therapy included atenolo 75 mg daily. atorvastatin calcium (lipitor) 60 mg daily, folic acid, vitamin A & C, albuterol sulfate (vantolin) and aspirin (ecotrin) 335 mg daily. On 17 Mar 2000. The patient experienced a temperature of 99.5 degrees fahrenheit. On 18 mar 2000 the patient ws nauseous and had an elevated blood pressure of 160/120. The patient went to the emergency from where the health care provider postulated that the patient;s experience was due to the vaccine. Additonally, it was reported that the patient had been in bed with flu - like sysmptoms but as of 20 Mar 2000 was feeling better. Acetaminophen Tylenol was prescribed prn and the patient will follow up with her health care provider. Follow up information from a physician reported that the results of the blood tests were not available. Additonally it was noted that the patient's bood pressure was 147/83 on arrival to the emergency room. The patient remains recovered. Y Y 03/15/2000 03/17/2000 2 Test: Blood Pressure, Date: 03/18/00, Normal Range: -, Comment: 147/83 on arrival to ER, Test: Blood Pressure, Date: 03/18/00, Normal Range: - , Comment: 150/120 prior to going to ER, Test: diagnostic laboratory, Date: 03/18/00, Normal Range: -, Comment: - Blood tests negative OTH OTH Ventolin, Astorbic acid, ecotrin mg, atenolol mg, lipitor mg, folic acid, vitamin a medical history: coronary bypass, Concurrent conditions; asthma, hyperlipidemia, panicillin allergy, hypertension, coronary artery disease. WAES00031959 1
0170970 06/01/2001 CO 50.0 50 F 05/15/2001 Varicella; Asthenia / fatigue; headache, pulmonary congestion - Information has been received from a health care professional concerning a 50 year old caucasian female patient with osteoporosis, depression, hypercholesterolemia, asthma, allergies to penicillin, sulfa and nuts and a history of hip surgery and fractures who on 06 mar 2000 was vaccinated sc at the left deltoid with a first dose of varicella virus vaccine live lot 631166/0708J. Concomitant therapy included alendronate sodium (MSD). omeprazola prilosec estrogens estorified (estratab), venlafaxine hydrochlorid (effexor), flouxetine hydrochloride prozac, pravastatin sodium pravachol, fluticasone propionstel flovent, zafirlukast accolate, eslmoterol 1- hydroxy 2- naphthoate serevent, albuterol sulfate (+) ipratropium bromide combivent. calcium supplement (nos), multivitamins, antioxidant tables and ascorbic acid. on 18 mar 2000 the patient experiented fatigue, requiring extended naps, mild headache, chest congestion and per sistent typical chickenpx lsions clustered at the left deltoid, posterior neck, right eyebrow, right thigh and mid back. It was noted that the patient was afebrile. The patient was seen in the physician's office. Follow up information reported that the patient recovered on 17 Mar 2000 and the plan is to check a varicella IgG in late April 2000. It was also noted that the patient was evaluated by an infectious disease specialist on 20 mar 2000. no further information is available at this time. Y Y 03/06/2000 03/18/2000 12 PVT UNK combivent, fosamax, ascorbic acid, calcius supplement (composition), estratas, frozac,flovent, prilosec, pravachol, serevent, effexor, vitamins, accolate medial history: fracture, hip surgery, concurrent conditions; asthma, nuts allergy, penicillin allergy, sulfa allergy, osteoporosis, hypercholesterolemia; depression WAES00031967 1
0170971 06/01/2001 FL M 05/15/2001 Varicella - Information has been received from aphysician concerning a male patient who on 12 Jan 1996 was vaccinated with varicella virus vaccine live On 01 Mar 2000, the patient presented with a severe case of varicella. The physician has a concern about the lot of vaccine administered 610251/074B. Additional information has been requested. Y U 01/12/1996 03/01/2001 1875 OTH OTH UNk UNK WAES00031977 1
0170972 06/01/2001 VA 1.08 M 05/15/2001 Blister - Information has been received from a health care proessional concerning a 13 month old caucasian male patient who on 02 Feb 2000 was vaccinated with the second dose of varicella virus vaccine live sc in the right thigh. On 10 mar 2000 the patient developed approximately 20 vesicls on his head, forehead and temple area. On 16 Mar 2000 the patient recovered from his experience. no futher information is available. Y PVT PVT UNK UNk WAES00032002 1
0170973 06/01/2001 VA 2.0 1 .5 M 05/15/2001 Varicella -Information has been received from a consumer concerning her 31 month old Caucasian son who on 28 Jan 1999 was vaccinated with a first dose of varicella virus vaccine live SC in the thigh. concomitant vaccinations that same day included a fourth dose of diphtheria toxoid (-) pertussia vaccine (+) tetanus toxoid lot number 457-788, IM in the thigh and a third dose of oral poliovirus vaccine lot number 456917. On 14 Mar 2000, the patient developed a case of chickenpox. The child's mother stated that he was very ill. had a fever for several days, and pox. in his mouth and ears. He did not sleep for three nights until medical attention was sought and a pedicatrician prescribed a strong antihistamine. Follow up information from a physician's office indicated that the patient did not have any pre-existing allergies or medical conditions. No further information is available. Y U 01/28/1999 03/14/2000 411 PVT PVT NONE WAES00032034 1
0170974 06/01/2001 PA 4.0 1 .3 M 05/15/2001 Varicella - Information has been received from a registered nurse concerning a 4 year old mael patient who on 19 May 1997 was vaccinated with a first dose of varicella virus vaccine live sc in the right thigh. On 20 mar 2000 the patient developed chicken pox. The reporter stated that the child developed chicken pox on his face and ears but does not have a fever or malaise. The physican office has not yet seen the child follow up information from a registered nurse indicated that the patient subsequently recovered. Follow up information from a registered nurse indicated the the patient had no further work up or visit. Y 05/19/1997 03/20/2000 1036 UNK UNK UNK UNK WAES00032089 1
0170975 06/01/2001 MI 41.0 40 F 05/15/2001 Lack Of Response - Information has been received from a 41 year old female with a history of cephalosporin allergy and two previous vaccinations, as scheduled, with the varicella virus vaccine live which resulted in a negative titer. This patient was vaccinated with one dose of varicella virus vaccine live this past summer. Unknown site concomitant therapies included omeprozole prilosec. Indoril and Penalar. subsequently the patient experienced a negative varicella antibody titer. The patient sought unspecified medical attention. Additional information has been requested. Y U 01/01/1999 01/01/1999 0 test: diagnostic laboratory, date: 07/07/99, normal range: - , comment: negative varicella antibody titer OTH OTH Prilosec medical history: cephalosporin allergy: vaccination WAES00032094 1
0170976 06/01/2001 KY 20.0 F 05/15/2001 Rash- Information has been received from a healthcare professional concerning a 20 year old female who was vaccinated with one dose of varicella virus vaccine live Unknow site. Three hours after receiving the vaccine, the patient experienced a papular rash on her trunk, arms, and neck which has persisted for four weeks. the patient sought unknown medical attention. Y U OTH OTH UNK UNk WAES00032103 1
0170977 06/01/2001 GA U 05/15/2001 Varicella - Information has been received from a school nurse concerning sight patients who were vaccinated with one dose of varicella virus vaccine live in the past (unknown site ) . subsequently the patients developed chicken pox. An unspecified number of the patients sought unspecified medical attention. Theere wer 105 cases of varicella in the school, but only eight of the patients were confirmed varicella virus vaccine live vaccine on a crude study by the school nurse. follow up was received for one specified patient wases 01033292. Additonal information has been requested. Y U OTH OTH UNK UNk WAES00032111 1
0170978 06/01/2001 CA M 05/15/2001 Varicella - Information has been received on 21 Mar 2000 from a healthcare professional concerning a male with a history of varicelle exposure who was vaccinated with one dose of varicella virus vaccine live within the last 1-2 years (unknown site ). Subsequently the patient experienced a mild case of chicken pox consisting of bumps with some vesicles. The reporter indiciated that the patient was afebrile. It was noted that the patient had an exposure to wild type virus two week ago. The patient sought unspecified medical attention. Follow up information received on 28 Apr 2000 from a healthcare professional indicated that the student caome down with a mild case of chicken pox after exposure some 20 days prior and that the varicelle virus vaccine live was given more than 1 year prior. No further information is available. Y U 01/01/1989 03/01/2000 4077 OTH OTH UNK concurrent condition: varicella exposure WAES00032117 1
0170979 06/01/2001 CA M 05/15/2001 Varicella - Information has been received from a health care professional concerning a male patient who 1- to 2 years ago was vaccinated with one dose of varicella virus vaccine live. In March 2000 the patient was exposed to wild type virus . Approximately 20 day later, he developed a mild case of varicella consisiting of bumps and a slight fever. He sought unspecified medical attention. No further information is available. Y U 01/01/1998 03/01/2000 790 UNK UNK medical history : varicella exposure WAES00032120 1
0170980 06/01/2001 CO 25.0 F 05/15/2001 Injection Site Vesicle - Information has been received from a registered nurse concerning a nurse in her 20's or 30's who was vaccinated SC with one dose of varicella virus vaccine live. Approximately 7 days post vaccination, the patient developed a blister with serious - like fluid under the skin at the injection site. Unspecified medical attention was sought. Another patient (waes #00040678) had a similar experience following exposure to varicella virus vaccine live. Additonal information has been requested. Y U UNK UNK UNK WAES00032132 1
0170981 06/01/2001 OH 4.0 0 .6 F Varicella - Information has been received from a registered nurse concerning a 4 year old female patient who on 11 Jul 1996 was vaccinated with varicella virus vaccine live. On 20 Mar 2000 the patient broke out in a mild form of chickenopox. it was noted that the patient was afebrile and only a few lesions were present. Unspecified medical attention was sought. no further information is available. Y U 07/11/1996 03/20/2000 1348 OTH OTH UNK UNK WAES00032134 1
0170982 06/01/2001 ME 31.0 F 05/15/2001 Lack Of Response - Information has been received from a physician concerning a 31 year old caucasian female patient 2ho on 11 Feb 1997 and 28 Mar 1997 was vaccinated with the first and second doses of varicella virus vaccine live. There was no concomitant medication. In march 2000 the patient sought medical attention and a serum varicella roster virus antibody test revealed a low titer. On 06 mar 2000 laboratory evaluation revealed rubella antibody IgG nomimmuna. It was reported that the patient wanted to get pregnant. No further information is available. Y U 03/28/1997 03/01/2000 1069 Test: laboratory test, Date: 03/06/00, Normal range: - , Comment: rubella ab 1gg nonimmune, Test: serum varicella roster, Date: 03/01/00, Normal range: -, Comment: revealed low-titer UNK UNK NONE UNK WAES00032142 1
0170983 06/01/2001 GA 5.0 5 F 05/15/2001 Somatoform Disorder, Mydriasis; syncope, examthema - Information has been received from a registered nurse concerning a 5 year old female who on 21 Mar 2000 was vaccinated with one dose of varicella virus vaccine live. On 21 Mar 2000 the patient experienced psychosomatic reaction. She passed out. her pupils were dilated. She was placed on an examination table and recovered uneventfully. On 23 Mar 2000 the patient experienced a generalized chickenpox type rash. Follow up was received which indicated could not find due to limited information. No futher information in available. Y 03/21/2000 03/21/2000 0 OTH OTH UNK UNk WAES00032358 1
0170984 06/01/2001 MI 5.0 3 M 05/15/2001 Varicella - Information has been received from a registered nurse concerning a 5 year old caucasian male patient who on 24 Jan 1998 was vaccinated SC in the right arm with one dose of varicella virus vaccine live (lot #62449/1422E). On 22 Mar 2000, two weeks after exposure to a contagious child at Mursory school. the patient experienced breakthrough chickenpox. It was noted that there were only 40 -50 pox with no other symptoms. Follow up information from a reqistered nurse reported that on an unspecified date, the patient recovered. Y 01/24/1998 03/22/2000 788 PVT OTH UNK Medical History: varicella exposure WAES00032359 1
0170985 06/01/2001 WI 33.0 F 05/15/2001 Lack of Response- Information has been received from a licensed practical nurse concerning a 33 year old female patient who on 01 Mar 2000 (lot # 629140/1835H) and 26 Apr 1999 (lot 629617 /0112J) was vaccinated SC with a first and second dose, respectively, of varicella virus vaccine live. On 25 Feb 2000 the paient had a titer checked and the level was less than 0.14 (less than 0.75 on scale indicates less than adequate). The second titer was checked on 16 Mar 2000 and the results were o.44 which is also less than adequate. Unspecified medical attention was sought. The report expressed a concern with the lot numbers. Additional information has been requested. 04/26/1999 02/26/2000 306 Test: serum varicella zoster; Date: 02/28/00, Value: 0.14, Normal Range: -, Comment: less than 0.75 on scale indicates inadequate antibodies, Test: serum varicella zoster; Date: 03/16/00, Value: 0.44, Normal Range: - , Comment: less than 0.75 on scale indicates inadequate antibodies UNK UNK UNK UNK WAES00032354 1
0170986 06/01/2001 CA 48.0 48 F 05/15/2001 Ophthalmic Burning; Ophthalmic stinging - Information has been received from a consumer who is a 48 year old caucasian female cma who on 23 Mar 2000 inadvertenlty got varicella virus vaccine live in her eyes when giving the vaccine to a child (waes 00040037) the same day of vaccination, the cma experienced burning and stinging of the eyes which was treated by flushing with water in a shower. The patient contacted the poison control center who recommended flushing again with water. Follow up information from a physician indicated that by the afternoon of 23 mar 2000 the eyes looked normal without increased tearing and no other problem afterward. The patient subsequently recovered. Y Y 03/23/2000 03/23/2000 0 PVT OTH UNK UNK WAES00032390 1
0170987 06/01/2001 VA 5.0 4 F 05/15/2001 Varicella - Information has been received from a physician concerning a 5 year old caucasian female patient with a penicillin allergy who on 09 Mar 1999 was vaccinated in the right anterior thigh with a first dose of varicelle virus vaccine live (lot 626149/1125h). It was noted that there were no illnessess at the time of vaccination. On 19 Mar 2000 the patient developed chickenpox. On 10 Mar 2000 the patient was examined in the physician's office. It was confirmed by a physician that the patient had chickenpox consisting of approximately 50 lesions scattered on the patient's face, trunk, extremities and vulva. Additionally, it was noted that the patient was afebrile. Follow up information reported that the patient had no adverse effects from varicella rash and subsequently recovered. Y Y 03/09/1999 03/19/2000 376 PVT PVT UNK concurrent conditions; penicillin allergy WAES00032495 1
0170988 06/01/2001 IN 5.0 3 F 05/15/2001 varicella - information has been received from a woman from a physician's office concerning a 5 year old female on 18 May 1998 was vaccinated Im in the left arm with one dose of varicella virus vaccine live. On 16 Mar 2000 the patient experienced a mild case of chickenpox. It was noted recovery expected. No further information is available. U 05/18/1998 03/16/2000 668 PVT PVT UNK UNK WAES00032474 1
0170989 06/01/2001 MD 1.25 M 05/15/2001 Fever; skin lesion- Information has been received from a physician concerning a her 15 month old son who on 14 Mar 2000 was vaccinated with one dose of varicella virus vaccine live lot 631467 /16823. On 21 Mar 2000 the patient experienced a fever of 104-105 degrees F and an eruption of 25 pimple-like lesions on the anterior trunkal area and on the back of the arms. The reporter indicated this was the sickest she had seen her child. There was no exposure to natual chickenpox. The pediatrician indicated the patient was healthy with no known problems, meeting all developmental milestones and up to date with his vaccination. He was not on any steroids. Medical attention was sought. No further information is available. Y U 03/14/2000 03/21/2000 7 test: body temp, date: 03/21/00, value: 104-1 degree, Normal range: -, UNK UNK UNK UNk WAES00032491 1
0170990 06/01/2001 CA 4.0 F 05/15/2001 Varicella - Information has been received from a physician concerning a 4 year old female patient who in approximately 1998 was vaccinated with varicella virus vaccine live at 2 years of age. On 23 Mar 2000, the patient devloped breakthrough varicella. The patient sought unspecified medical attention and a culture was obtained. Additional information has been requested. Y U 01/01/1998 03/23/2000 812 test: diagnostic laboratory, normal range: -, comment: lesion culture - results pending OTH OTH UNK UNK WAES00032553 1
0170991 06/01/2001 MD 1.0 F 05/15/2001 Rash, Cough, Fever - Information has been received from a registered nurse concerning a 1 year old female who on 01 Feb 2000 was vaccinated with one dose of varicella virus vaccine live. On 10 Feb 2000 the patient experienced a rash of red bumps which started on the face, slight fever, and cough. She presented to a physician. Y U 02/01/2000 02/10/2000 9 OTH OTH UNK UNK WAES00032574 1
0170992 06/01/2001 TX 4.0 F 05/15/2001 varicella, cough, nasal secretion - Information has baeen received from a registered nurse concerning a 4 year old caucasian female patient who on 11 Mar 1997 was vaccinated with a first dose of varicella virus vaccine live. On 18 Mar 2000 the patient began to develop lesions. On 20 Mar 2000 the physician's office was notified that the patient has 25 lesions in all stages of chickenpox. Additionally, the patient has a slight cough and runny nose. The patient was afebrile and the lesions were reported as non-pruritis. It was noted that the patient is doing well and that her mother is to monitor her. Additonal information has been requested. U 03/18/2000 NON OTH OTH UNK UNK WAES00032342 1
0170993 06/01/2001 IN 27.0 27 F 05/15/2001 Rash - Information has been received from a 27 year old female consumer who on 15 mar 2000 vaccinated with one dose of varicella virus vaccine live (site unknown). there was no concomitant medication. on 24 mar 2000 the patient experienced a rash that is red with some raised spots around the injection site. the patient sought unspecified medical attention. at the time of the report 27 mar 2000 the patient's rash presisted. Y N 03/15/2000 03/24/2000 9 OTH OTH NONE UNK WAES00032663 1
0170994 06/01/2001 33.0 F 05/15/2001 Skin lesion - Information has been received from a physician concerning a 33 year old female family member who in approximately february, 2000 was vaccinated with one dose of varicella virus vaccine live (site unknown). Approximately two weeks post-vaccination. the patient experieced about 5-10 vesicular lesions diffusely over her body, the patient received unspecified medical attention and the rash subsequently resolved. Y Y 02/01/2000 OTH OTH UNK UNK WAES00032670 1
0170995 06/01/2001 4.0 0 .9 F 05/15/2001 Herpes Zoster - Information has been received from a health care professional concerning a 4 year old female who in December, 1996 was vaccinated with one dose of varicella virus vaccine live (site unknown) Subsequently the patient was diagnosed by physician with a small patch of zoster on the back of the upper arm. Additional information has been requested. Y U 12/01/1996 OTH OTH UNK UNK WAES00032706 1
0170996 06/01/2001 NJ 9.0 9 M 05/15/2001 On 3/27/00 the pt developed red papular lesions scattered on his trunk, extremities and groin. It was noted that they were not pustules and not vesicles. There was also a large area at the left deltoid (immunization site) that was red, indurated and raised with pustules at the center. It was noted that the pt had no fever or malaise. Unspecified medical attention was sought. Follow-up states the pt recovered. Y Y 03/15/2000 03/27/2000 12 serum varicella - non immune OTH OTH UNK seizure disorder WAES00032719 1
0170997 06/01/2001 WV 1.8 1 .5 M 05/15/2001 Fixed Drug Eruption - Information has been received from a physician concerning a 22 month old caucasian male patient with Krb's palsy who on 17 Nov 1999 was vaccinated in the right arm with a first dose of varicella virus vaccine live (lot 631773/1033j. On 21 Mar 2000 the patient broke out with chickenpox. The patient is not yet recovered. Follow up information from a physician noted that after the patient was seen in the physician's office on 23 Mar 2000 it was determined that the rash reported was not due to varicella virus vaccine live but was a fixed drug eruption secondary to amoxicillin. Y N 11/17/1999 03/21/2000 125 UNK UNK UNK concurrent condition: Erb's palsy WAES00032740 1
0170998 06/01/2001 TX 4.0 4 F 05/15/2001 Varicella - Information has been received from a registered nurse concerning a 4 year old female patient with allergies and who was exposed to varicell a who on 10 Mar 2000 was vaccinated with varicella virus vaccine live. Concomitant therapy included loratadline (claritin). On 21 Mar 2000 the patient developed a rash that consisted of red slightly raised lesions about the size of a pencil erasure. There was no blistering and no fever. The patient sought unspecified medical attention. Follow up information from a registered nurse indicated that on 24 Mar 2000 was diagnosed with a case of breakthrough chickenpox that consisted of a red raised area on the torso, neck, and legs without blistering. she had new spots every day for four days. The nurse did not consider this a reaction to varicella virus vaccine live, but rather contracted a modified case of varicella due to disease exposure prior to her having had the vaccine. Additional information has been requested. Y U 03/10/2000 03/21/2000 11 OTH OTH claritin concurrent conditions: allergy varicella exposure WAES00032811 1
0170999 06/01/2001 CO 2.3 M 05/15/2001 Subsequent to receiving vax, the pt developed a mild form of chicken pox with approximately 3 lesions. The pt sought unspecified medical Treatment. Additionally the reporter noted that there was an outbreak of chicken pox within the school district approximately 10 - 20 days before the pt developed chicken pox. No further information is available. Y U OTH OTH UNK varicella exposure WAES00032813 1
0171000 06/01/2001 WI 3.25 3 F 05/15/2001 One day post vax the pt developed a rash on the middle of her chest. 14 days (03/14/2000) later the pt experienced difficulty in moving her hands and toes. The next day (03/15/2000), she experienced difficulty moving her right knee. On 03/21/2000, the pts physician prescribed Arthrotec for joint pain because Alleve did not work. The pt was still experiencing joint pain, inflammation and itching on her chest. Additional information has been requested. Y U 02/28/2000 03/01/2000 2 OTH OTH UNK WAES00032825 1
0171001 06/01/2001 M 05/15/2001 On 02/28/2000, the pt developed a breakthrough case of shingles on his right leg, below his knee and down to his foot. The pt sought medical attention and was treated with calamine lotion for the itching. At the time of the report he had dried scabs on his leg. No further information is available. Y U 10/28/1999 02/28/2000 123 UNK UNK UNK UNK WAES00032839 1
0171002 06/01/2001 MA 2.0 2 .0 F 05/15/2001 On 03/27/2000, the pt developed an injection site rash consisting of 2 - 3 dots. The pt sought unspecified medical attention and according to follow-up information, from the physician, has recovered. No further information is available. Y Y 03/13/2000 03/27/2000 14 PVT PUB UNK NONE WAES00032852 1
0171003 06/01/2001 CA 13.0 M 05/16/2001 Subsequent to receiving vax, the pt presented to a physician's office with shingles described as at least 100 lesions on the right side of his waist above the waist line. They were very painful. The pt was prescribed Vicodin for pain which was 8/10 on a pain scale of 1 - 10. The pt was also prescribed elavil 25 mg at night for 3 months to protect against postherpetic neuralgia. On an unspecified date the patient fully recovered without any problems. No further information is expected. Y Y OTH OTH UNK UNK WAES00032045 1
0171004 06/01/2001 MI 25.0 F 05/15/2001 Subsequent to receiving first and second doses of varicella virus vaccine live the pt experienced a lack of seroconversion. The pt sought unspecified medical attention. Y U 12/21/1999 negative varicella antibody OTH MIL Duricef; Entex; Synthroid hypothyroidism WAES00032951 1
0171005 06/01/2001 CT 34.0 34 F 05/15/2001 Several days post vax, the pt developed a varicella like rash around the injection site. The pt sought unspecified medical attention. The pt did not report any further side effects and at an unspecified date recovered. No further information is expected. Y Y 02/11/2000 OTH OTH UNK UNK WAES00032957 1
0171006 06/01/2001 OK 1.25 1 .3 M 05/15/2001 Nine days post vax, the pt experienced 30+ lesions throughout body and a temperature of 100.8 degrees F. He was treated with acetaminophen. Subsequently, he recovered. No further information is available. Y 03/20/2000 03/29/2000 9 PVT PUB varicella exposure WAES00032992 1
0171007 06/01/2001 TX 1.0 1 .0 F 05/15/2001 Ten days post vax, the pt experienced a mild rash that was smooth on her stomach and bumpy on her legs. The bumps were small. She also experienced a red bump on her face. The pt was also fussy since she developed the rash. No further information is available. U 03/17/2000 03/27/2000 10 OTH OTH NONE NONE WAES00032998 1
0171008 06/01/2001 IL 2.6 2 .5 M 05/15/2001 On 03/15/2000, the pt developed cold symptoms, a rash with 15 lesions, a low grade temperature, and no appetite. The pt subsequently recovered. No further information is available. Y 10/04/1995 03/15/2000 1624 UNK UNK UNK UNK WAES00033040 1
0171009 06/01/2001 PA 1.5 1 .5 M 05/15/2001 In March 2000, the pt developed a mild case of chickenpox consisting of approximately 40 lesions. It was also noted that the pt had a mild fever and not ill. Follow-up information from a nurse practitioner reported that on approximately 03/10/2000 the pt recovered. Y 09/26/1997 03/01/2000 887 PVT PVT UNK dysplasia WAES00033119 1
0171010 06/01/2001 VA 3.25 4 M 05/15/2001 On Feb. 9, 2000, the pt developed chicken pox. The pt presented to a physician with 35 pox. No treatment was given. Additionally it was noted that 2 other pts experienced similar reactions. Follow-up information from a physician indicated that on 02/17/2000, the pt recovered. Y Y 07/15/1996 02/09/2000 1304 PVT PVT UNK UNK WAES00033123 1
0171011 06/01/2001 NJ F 05/15/2001 lack of response - information has veen received from a health care profesional concerning an adult female patient who in approximately 1999 was vaccinated with the varicella viurs vaccine live series . Subsequently the patient had a negative titer. Unspecified medical attent was sought. Y U 01/01/1999 test: serum varicella zoster, Normal range: - , Comment: negative titer after receiving varivax series. OTH OTH UNK UNk WAES00033125 1
0171012 06/01/2001 KS 6.0 3 F 05/15/2001 Varicella - Information has been received from a physician concerning a 6 year old caucasian female who on 24 Jun 1997 was vaccinated SC with the first dose of varicella virus vaccine live (site unknown) Lot # 621195/0638e. On 24 Mar 2000 the patient developed a fever of 104 F and chicken pox like lesions. The patient sought unspecified medical treatment and was diagnosed with varicella. Additonal Information has been requested. Y U 06/24/1997 03/24/2000 1004 PVT PVT UNK UNK WAES00033140 1
0171013 06/01/2001 MA 7.0 3 F 05/15/2001 Varicella- information has been received from a licensed practical nurse concerning a 7 year old female who on 31 May 1996 was vaccinated with one dose of varicella viurs vaccine live SC in the left arm. On 28 feb 2000 the patient experienced a varicella rash on the legs, chest, back, buttocks, and neck. The lesion were itchy and fluid-filled. Diphenhydramine HCL (Benadryl) was prescribed. Subsequently, the patient recovered. Y 05/31/1995 02/26/2000 1732 PVT OTH UNK UNK WAES00033231 1
0171014 06/01/2001 MA 1.0 1 .0 F 05/15/2001 Injection Site Infection - Information has been received from a physician concerning a 12 month old female patient who on 22 Mar 2000 was vaccinated SC with the first dose of varicella virus vaccinelive (Lot #631068/1345J) in the left thigh. On 30 Mar 2000 the patient developed three dime size lesion (pustules) around the injection site. The patient sought unspecified medical attention on the unspecified date the patient recovered. No further information is available. Y Y 03/22/2000 03/30/2000 8 PVT PVT UNK UNK WAES00040005 1
0171015 06/01/2001 CA 11.0 11 F 05/15/2001 Afflication Site Reaction: Skin Erythema; swelling - Information has been received from a physician concerning a 11 year old white female who on 23 Mar 2000 was vaccinated with the first dose of varicella virus vaccine live (lot 632041/1399J) in the right deltoid, concomitant medication included the sixth dose of diptheria toxoid (+) tetanus toxoid (adult) in the left deltoid and tetracycline. On the same day, the patient developed a local reaction with redness and swelling after only a partial dose was given. During the vaccination the syrings came away from the needle and part of the vaccine squirted out and was sprayed into the eye of another person (waes 000323901) the patient sought unspecified medical attention. No further information is expected. Y Y 03/23/2000 03/23/2000 0 NONE PVT OTH tetracycline NONE WAES00040037 1
0171016 06/01/2001 OH 5.0 4 F 05/15/2001 Varicella - Information has been received from a registered nurse concerning a 5 year old female who on 30 dec 1998 was vaccinated with the first dose of varicella virus vaccine live in the left arm (lot 628182/1327H) on 29 Mar 2000, the patient developed chickenpox with about 100 pox and a low grade fever. The patient sought unspecified medical attention, follow up information received 17 apr 2000 from a registered nurse reported that the patient has recovered. Y Y 12/30/1998 03/29/2000 455 PVT OTH UNK UNK WAES00040050 1
0171017 06/01/2001 NY F 05/15/2001 lack of response - Information has been received from a doctor of pharmacy concerning a female patient who in February and April 1999 was vacicnated with a first and second dose, respectively, of varicella virus vaccine live. Subsequently on approximately 07 mar 2000 the patient was tested for antibodies and an undetectable lever was found. Unspecified medical attention was sought. Y U 04/01/1999 03/07/2000 341 Test: serum varicella zoster, Date: 03/01/2000, Normal Range: - , Comments: antibody at an undetectable leverl. UNK UNK UNK UNK WAES00040058 1
0171175 06/01/2001 VA 1.08 1 .1 F 05/15/2001 Varicella - Informaiton has been received from a physician concerning a 13 month old white female with streptococcal tonsillitis with markedly enlarged and hymtrophoid tonsils 2 weeks prior to vaccination who on 15 Mar 2000 was vaccinated with the first dose of varicella virus vaccine live SQ in the left thigh lot 632049/1365J. On 30 Mar 2000 ,the physician reported that the patient looks like she had developed chickenpox on trunk and thighs about 10 papules. Y Y 03/15/2000 03/30/2000 15 PVT PVT UNK streptoccoccosis: tonsillar enlargement tonsillitis UNK WAES00040059 1
0171176 06/01/2001 IN F 05/15/2001 Varicella - information has been received from a health care profesisonal concerning a caucasian female patient who on 17 Sep 1997 and 20 Oct 1997 was vaccinated with the first and second doses respectively. of varicella virus vaccine live IM in the left arm. On 27 Mar 2000 the patient broke out in about 15 pox. No further information is available. U 10/20/1997 03/24/2000 886 PVT PVT UNK UNK WAES00040077 1
0171177 06/01/2001 CT 1.0 12 F 05/15/2001 Vesiculobulious Rash - Information has been received from a physician concerning a 12 year old black female patient who on 20 Mar 2000 was vaccinated with a first dose of varicella virus vaccine live lot 632371/1464J SC in the right deltoid. On 27 Mar 2000, the patient developed a vesicular rash. The patient sought unspecified medical attention. follow up information from a physicaian indicated that the patient subsequently recovered. Y Y 03/20/2000 03/27/2000 7 OTH OTH UNK UNK WAES00040192 1
0171178 06/01/2001 NJ 1.8 1 .1 F 05/15/2001 varicella - information has been received from a physician concerning a 20 moth old caucasian female who on 18 Aug 1999 was vaccinated sc with the first dose of varicella virus vaccine live in the right arm Lot 631169/0711J. Concomitant therapies included the third dose of hepatitis b vaccine recorbinant yeast Med lot 628414/1478H in the left deltoid and tuberculin. On 23 Mar 2000 the patient was diagnosed with full blown chicken pox. The patient was treated with a cyclovir (zoviraz) 2.5 ml four times a day for 5 days . Subsequendly. the patient recovered. Y Y 08/18/1999 03/23/2000 218 PVT PVT tuberculin, old, tine test UNK WAES00040256 1
0171179 06/01/2001 VA 2.0 0 .3 F 05/15/2001 Varicella - Information has been received from a physician concerning a 2 year old female who in 1998 was vaccinated with one dose of varicella virus vaccinelive (site Unknown). In 200 the patient developed chicken pox. The patient sought unspecified medical treatment. Additionally, it was noted that 2 other patients waes 00033123 and 00040359 experienced similar reactions. Additional information has been requested. Y U 01/01/1998 01/01/2000 730 OTH OTH UNK UNK WAES00040258 1
0171180 06/01/2001 VA 1.08 F 05/15/2001 Varicella - Information has been received from a physician concerning a 13 year old female who in September, 1996 was vaccinated with one dose of varicella virus vaccine live site unknown. In 2000 the patient developed chicken pox lesions. the patient sought unspecified medical treatment. Additonaly it was noted that 2 other patient waes 00033123 and 000402581 experienced similar reactions. Additional information has been requested. Y U 09/01/1996 01/01/2000 1217 OTH OTH UNK UNK WAES00040259 1
0171181 06/01/2001 MI 7.0 3 F 05/15/2001 vesiculobullous rash - information has been received from a woman in a physician's office concerning a 7 year old female patient who on 28 mar 1996 was vaccinated with a second dose of varicella virus vaccine live (lot 616866/1508b) It was noted that the office did not state which arm. On 27 mar 2000 the patient developed a vasicular rash on her right trunk that consisted of more than 50 that were 2 inches apart. Y 03/28/1996 03/27/2000 1460 PVT OTH UNK UNK WAES00040261 1
0171182 06/01/2001 LA 3.0 1 .1 M 05/15/2001 Uaricella - Information has been received from a registered nurse concerning a 40 month old male who on 09 Jan 1998 was vaccinated with one dose of varicella virus vaccine live sc in the left arm. there was no concomitant medication. On 04 apr 2000 the patient experienced chickenpox with 25-30 lesions on the chest, back, and face. he was seen by a physician. he was given diphenhydramine HCL (benadryl as needed Y U 01/09/1998 04/04/2000 816 UNK UNK NONE UNK WAES00040318 1
0171183 06/01/2001 LA 2.0 1 .1 M 05/15/2001 Varicella - Information has been received from a registered nurse concerning a 2 year old male patient who on 25 feb 1999 was vaccinated with varicella virus vaccine live on 04 apr 2000 the patient was diagnosed with chickenpox. The reporter noted that she did not see the patient and that the number of lesions was not documented in the patient's chart. Y U 02/25/1999 04/04/2000 404 OTH OTH UNK UNK WAES00040320 1
0171184 06/01/2001 34.0 M 05/15/2001 Skin Lesion, Cough - Information has been received from a waman concerning a 34 year old male family member who on 14 Mar 2000 was vaccinated with varicella virus vaccine live. On 14 Mar 2000 the patient experienced 15 itchy lesions in the hair, bottom, back, and legs. he also experienced a slight cough at night U 03/14/2000 03/14/2000 0 OTH OTH UNK UNK WAES00040321 1
0171185 06/01/2001 PA 16.0 M 05/15/2001 Lack of response - Information has been received from a registered nurse concerning a 16 year old male patient who in 1988 was vaccinated with varicella virus vaccine live during a clinical trail. On 23 Mar 2000, the patient's antibody titer was negative. Additional information has been requested. Y U 01/01/1988 03/23/2000 4465 test: serum varicella zoster, Date: 03/23/00, Normal Range: - , Comment: negative, OTH OTH UNK UNK WAES00040326 1
0171186 06/01/2001 10.0 M 05/15/2001 Varicella - Information has been received from a consumer concerning his 10 year old grandson who in 1999 was vaccinated with varicella virus vaccine live. In 2000, the patient devoleped chickenpox. Additional information has been requested. U 01/01/1999 01/01/2000 365 OTH OTH UNK UNK WAES00040338 1
0171187 06/01/2001 5.0 3 F 05/15/2001 varicella - Information has been received from a licensed practical nurse concerning a 5 years old female who on 19 Sep 1997 was vaccinated with one dose of varicella virus vaccine live. On 02 Apr 2000 the patient expericenced varicella. The patient's father statated this was the mildest case he had seen in his children U 09/19/1997 04/02/2000 926 OTH OTH UNK UNK WAES00040427 1
0171188 06/01/2001 WI 25.0 M 05/15/2001 Lack of response - information has been received concerning a 25 year old male who in August 1997 and october 1997 was vaccinated with the first and second doses of varicella virus vaccine live . In 2000 laboratory evaluation revealed a lack of response. U 10/01/1997 01/01/2000 822 test: serum varicella zoster, date: 010100, normal range: -, comment: negative after two doses, OTH OTH UNK UNK WAES00040433 1
0171189 06/01/2001 VA 47.0 47 F 05/15/2001 Headache; arthralgia; chills, fever, nausea, malaise, hot flashes, dizzness - Information has been received from a registered nurse concerning a 47 year old female patient with hypertension, gastroesophageal reflux disease and allergies to acetaninophen (-) oxyondone hydrochloride (percocet) and trazadol) hydrochloride (ultram). It was noted that the patient also has a reported history of varicella however, her titer was shown to be unequivocal. Additionally, it was noted that the patient was exposed to varicella in the hospital and was consequantly vaccinated in the left deltoid with a first dose of varicella virus vaccine live on 28 Mar 2000 (631169/0711J). concomitant therapy included fosinopril sodium salt (monopril) norethindrone acetate (Aygestin), omeprarole (prilosec) and hydrochlorothlaride (manufacturer unkown). On 38 Mar 2000 the patient developed a headache that became serve. She also experienced dizziness, chills, hot flashes, her temperature increased to 99.4 and aching joints especially in her right knee, left elbow with the greatest pain in her right shoulder. Additionally, it was noted that the patient experienced nauses and malaise. Follow up information from a registered nurse reported that on an unspecified date the patient recovered. Y 03/28/2000 03/28/2000 0 test; serum varicella zoster, normal range -, comment titer shown to be unequivoccal PUB OTH monopril, hydrochlorothiaride, aygestin, prilosec Medical History: varicella, varicella exposure , Concurrent conditions: drug allergy; drug allergy; gastroesophageal reflux disease; hypertension. WAES00040446 1
0171190 06/01/2001 MI 5.0 1 .6 F 05/15/2001 Varicella - Information has been received from a registered nurse concerning a 6 year old female patient who on in August of 1995 was vaccinated with varicella virus vaccine live. On approximately 05 apr 2000. the patient developed chickenpox. The patient has not been seen by a physician. U 06/01/1995 04/05/2000 1770 OTH OTH UNK UNK WAES00040479 1
0171191 06/01/2001 MI 7.0 6 F 05/15/2001 Vesiculobullous Rash - Information has been received from a physican's office concerning a 7 year old caucasian female patient who on 26 May 1999 was vaccinated sc in the left arm with one dose of varicella virus vaccine live (lot 629163/0308J) On 02 apr 2000 the patient experienced a vasicular rash. It was noted that the patient had no recent varicella exposure. On 03 Apr 2000 the patient was seen by a physican . A swab of lesion was obtained to rule out varicella. follow up information reported that DFA and culture for herpes simplex and varicella zoster virus were obtained. Preliminary isolation was negative at 24 hours on 06 Apr 2000 and negative at 48 hours on 07 Apr 2000. Final isolation result was negative at 96 hours. The DFA result on 10 Apr 2000 revealed too few cells for reliable interpretation. Y U 05/25/1999 04/02/2000 313 test: diagnostic laboratory, date: 04/10/2000, normal range: -, Comment- DPA --too few cells for reliable interpretation, Test: herpes simple virus, Date: 04/10/00, Normal Range -, comment - final isolation negative at 96 hours, Test- serum varicella zoster, Date: 04/10/00, normal range: -, comment: final isolation negative at 96 hours. PVT UNK UNK UNK WAES00040521 1
0171192 06/01/2001 OR 1 .2 F 05/15/2001 varicella - Information has been received from a registered nurse concerning a 4 year old female patient who on 04 Apr 1997 was vaccinated with varricella virus vaccine live. There was no concomitant medications. Known allergies or past medical history. In March 2000 the patient developed a mild case of chickenpox. U 04/04/1997 03/01/2000 1062 OTH OTH NONE NONE WAES00040541 1
0171193 06/01/2001 CA 1.25 0 .0 M 05/15/2001 Varicella - Information has been received from a registered nurse concerning a 15 month old Caucasian male patient with an otic infection and a history of respiratory syncytical virus infection at 2 months of age who on 05 jan 1999 was vaccinated with a dose of varicella virus vaccine live IM. Concomitant vaccinations included a first dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) MSD sq in the left arm. On 05 apr 2000 the patient developed mild breakthrough varicella that consisted of 10-15 lesions. The patient was afebrile. The patient was seen by a physician for a recheck of an ear infection that was presisting. additonal information has been requested. Y U 01/05/1999 04/05/2000 456 PVT OTH Medial History: raspiratiory syncytial virus infection : Concurrent Conditions: otic infection WAES00040571 1
0171195 06/01/2001 CO 37.0 37 F 05/15/2001 Injection site rash: injection site inflammation: injection site pain, injection site pruritus - information has been received from a health care professional concerning a 37 year old caucasian female patient with a heart murmur, type 11 diabetes mellitus, mild asthma hay fever and allergies to wool, multa and possibly erythromycin who on 11 apr 2000 was vaccinated sc in the right arm with a second dose of varicella virus vaccine live Lot 631078/0706J. there were no illnesses at the time of vaccination. On 13 apr 2000 the patient developed a rash approximately 3 inches long and 1 inch wide at the injection site. It was note that the rash was pruritic, painful and inflamed. The rash lasted approximately one week, but the site remained tender and sore for one week after the rash disappeared. Within two weeks of vaccination, the symptoms had resovled. It was noted that the patient had the same experience following vaccination with the first dose of varicella virus vaccine live except that the rash was not as large. Another patient Waes 00032123 had a similar experience following exposure to varicella virus vaccine live. Y 04/11/2000 04/13/2000 2 PUB PVT UNK concurrent condition: allergy, asthma, cardiac murmur, erythroaycin allergy, hayfever, sulfa allergy, type 2 diabetes mellitus injection site rash~Vaccine not specified (no brand name)~1~0.00~In Patient WAES00040678 1
0171196 06/01/2001 MI F 05/15/2001 Herpes zoster, secondary transmission - Information has been received from a female nurse who developed shingles following exposure to a child who was vaccinated with varicella virus vaccine live. Unspecified medical attention was sought. Follow up information from the nurse report that upon further investigation, she concluded that the child probable did not receive varicella virus vaccine live because the child was not old enough according to current dosing schedule. she noted that the outbreak of herpes zoster was probably not due to exposure. Y U NONE OTH OTH UNK UNK WAES00040756 1
0171197 06/01/2001 WA F 05/15/2001 Rash, secondary transmission - Information has been received from a registered nurse concerning a female patient with a history of varicella who was exposed to her son who on 04 Apr 200 was vaccinated with varicella virus vaccine live. Three days post vaccination, the patient devloped a rash all over that consisted of red spots. The patient sought unspecified medical attention. Additonal information has been requeste. Y U 04/07/2000 OTH OTH UNK Medial History: varicella WAES00040757 1
0171198 06/01/2001 FL M 05/15/2001 Injection site erythema, injection site swelling - Information has been received from a registered nurse concerning a male patient who was vaccinated with one dose of varicella virus vaccine live (lot 632059/1452J). Subsequently the patient experienced redness and swelling at the injection site. It was noted that this did not spread to other parts of the body. Unspecified medical attention was sought. Additional information has been requested. Y U UNK UNK UNK UNK WAES00040774 1
0171199 06/01/2001 NY 1.9 1 1 M 05/15/2001 Mass; contusion, rash, fever - information has been received from a family member concerning a 23 month old male who on 04 Apr 2000 was vaccinated with one dose of varicella virus vaccine live in the arm. on 08 Apr 2000 the patient devloped a 2X3 inch lesion on his inner thigh and he had a fever 100.2 F. The patient was taken to the emergency room for evaluation. It was noted that the patient had signs of infection and that a white blood cell count was elevated. On 09 apr 2000 the patient's lesions were noted as oozing and surrounded by little bruised that went all the way up the length of his leg to his buttocks. On 10 apr 2000 the patient had a rash on his face on 10 lesions and only some of them looked like chickenpox. Additional information has been requested. Y 04/04/2000 04/08/2000 4 test: wbc count; date: 04/08/2000, normal range: - , comment: elevated OTH OTH UNk WAES00040796 1
0171200 06/01/2001 AR 3.0 F 05/15/2001 varicella - Infromation has been received from a registered nurse concerning a 3 year old female patient who on 13 Dec 1997 was vaccinated with a first dose of varicella virus vaccine live sc in the the right lateral thigh. Concomitant vaccinations included measles mumps rubella vaccine MSD hib conjugate vaccine MSD and diphtheria toxoid (+) pertussia vaccine (+) tetanus toxoid. On 04 apr 2000 the patient developed breakthrough variecella described as a mild case of classic varicella. Addditonal information has been requested U 12/12/1997 04/04/2000 844 PVT PVT UNK WAES00040949 1
0171201 06/01/2001 CA 1.0 1 .1 M 05/15/2001 Information has been received from a physician concerning a 23 month old white/Japanese male who on 05/25/1999 was vaccinated with the first dose of varicella virus vaccine live SC in the left anterior thigh. On 04/06/2000, the pt developed a mild form of chicken pox. It was noted by the pts mother that the rash is not scabbing over. The reporter noted that the pt was not seen in the clinic. On 04/15/2000, the pt recovered. No further information is expected. Y 05/25/1999 04/06/2000 317 PVT OTH UNK UNK WAES00040991 1
0171203 06/01/2001 3.0 4 F 05/15/2001 Herpes Zoster - Information has been received from a consumer concerning her 43 month old female family mumber who in August, 1999 was vaccinated with one dose of varicella virus vaccine live (site unknown). In January 2000 the patient developed whingles on her arm and recovered at an unknown date. Prior to 11 Apr 2000, the patient developed shingles on the name arm again, and the outcome is unknown. The patient sought unspecified medical attention. Additional information has been requested. Y U 08/01/1999 01/01/2000 153 OTH OTH UNK UNK WAES00041018 1
0171204 06/01/2001 RI U 05/15/2001 Varicella - Information has been received from a healthcare professional concerning 15 students ranging in ages from kindergarten to third grade who at unknown dates were vaccinated with a dose of varicella virus vaccine live (Site unknown). The reporter stated that in April 2000 a total of 19 students from one school including those that were vaccinated, had developed chicken pox. An undetermined number students sought unspecified medical attention. Also reported were 3 students from another school who werre vaccinated and experienced similiar events (wases 00042153). follow up information receive on 31 may 2000 from a public heatlh administration woman indicated that by the time they got the report of the varicella outbreaks, the information was 3 weeks old and she does not have any additional information. No further information is available. Y U 04/01/2000 OTH OTH UNK UNK varicella~Vaccine not specified (no brand name)~~0.00~In Patient WAES00041090 1
0171205 06/01/2001 MI 3.0 3 U Varicella - Information has been received from a healthcare professional concerning a 5 year old male who on 06 Aug 1997 was vaccinated with a dose of varicella virus vaccine live (Site unknown). On 11 Apr 2000. following a chicken pox outbreak at school, the patient experienced chicken pox and the reporter seated that on 12 Apr 2000. the patient had about 20 lesions. unspecified medical attention was sought. Y U 08/06/1997 04/11/2000 979 OTH OTH UNK concurrent conditions; varicella exposure WAES00041096 1
0171206 06/01/2001 MI 2.0 1 .0 M 05/15/2001 Varicella - Information has been received from a healthcare proessional concerning a 25 month old male who on 19 Feb 1999 was vaccinated with one dose of varicella virus vaccine live (site unknown). On 07 Apr 2000 the patient developed chicken pox with 20-25 lesions. The patient sought unspecified medical attention. Y U 02/19/1999 04/07/2000 413 OTH OTH UNK UNK WAES00041107 1
0171207 06/01/2001 MA 4.0 1 .7 M 05/15/2001 Varicella - Information has been received from a physican concering a 4 year old asian male with eczema who on 31 Jul 1997 was vaccinated with the first dose of varicella virus vaccine live (lot 13980) (site unknown). On 06 apr 2000 the patient developed chicken pox with lesions noted on the face, back and trunk. The reporting physician noted that there was no evidance of secondary infection. Additonal information has been requested. Y U 07/31/1997 04/06/2000 980 PVT OTH UNK concurrent conditions: eczema WAES00041140 1
0171208 06/01/2001 MA 1.08 1 .0 F 05/15/2001 Rash - Information has been received from a health care professional concerning a 13 month old female who on 18 mar 2000 was vaccinated with one dose of varicella virus vaccine live (site unknown). On 07 apr 2000 the patient developed a rash. The patient sought unspecified medical treatment Additional information has been requested Y U 03/18/2000 04/07/2000 20 OTH OTH UNK UNK WAES00041143 1
0171209 06/01/2001 WA 1.33 F 05/15/2001 Info has been received from a physician concerning a 16 month old female who on 03/10/2000 was vaccinated witih one dose of varicella virus vaccine live (site unknown). On 04/11/2000 the pt developed a rash on her chest that looks like shingles. The reporter noted that the rash was not particularly painful and the pt had no systemic symptoms. On 04/12/2000 the physician did a "viral culture" and the results were not reported. The physician expressed an interest in submitting the specimen for PCR analysis. Follow-up info received on 04/28/2000 from the physician indicated that a specimen has not been sent for PCR analysis due to the fact that "we haven't isolated anything yet". The Herpes Gp Culture and DFA Viral Culture specimen Herpes Cp FA collected on 04/12/2000 showed results inconclusive. No further info is available. Y Y 03/10/2000 04/11/2000 32 Herpes simplex virus -results inconclusive OTH OTH UNK UNK WAES00041150 1
0171210 06/01/2001 TX 4.0 1 .2 F 05/15/2001 Skin Lesion: Fever; Pruritus - Information has been received from a registered nurse concerning a 5 year old caucasion female who on 26 Jul 1996 was vaccinated with one dose of varicella virus vaccine live sc in the left arm. Concomitant therapy included one dose of mealses-mumps-rrubella vaccine (msd) adinistered sc in the right arm. On 01 mar 2000 the patient experienced 10-15 itchy lesions and a slight low grade temperature. it was noted the mother to start colloid oatmeal (aveeno) baths and diphenydramine HCL (Benadryl - subsequently, the patient recovered. Y 07/26/1996 03/01/2000 1314 PVT PVT UNK WAES00041168 1
0171211 06/01/2001 OH 6.0 M 05/15/2001 Varicella - information has been received from a registered nurse concerning a 6 year old male patient who on 01-Nov 1995 was vaccinated with varicella virus vaccine live . on 30 mar 2000, the patient developed chickenpox consisting of approximately 50 lesions. The patient sought unspecified medial attention. Additional information has been requested. Y U 11/01/1995 03/30/2000 1611 OTH OTH UNk UNK WAES00041274 1
0171212 06/01/2001 OH U Varicella - information has been received from a healthcare professional concerning a 6 year old female who on 26 aug 1996 was vaccinated with one dose of varicella virus vaccine live (site unkown) on 11 apr 2000 the patient experienced full blown chicken pox, greater than 200 lesions. In follow up information from a healthcare professional it was reported that to her knowledge, the child was doing well and had no complications to date from the chickenpox. The patient does have a pretty severe case of chickenpox, with at least several hundred generalized lesions. The reporter stated that she had not spokken with the child's mother in several days. so she does not really have any additonal case information to add, nor does she have any knowledge about a history of recent varicella exposure. With respect to the patient's history the reporter stated that the child has asthma, and has a history of intermittent steroid use. The child was most recently started on steroids in february, 2000. The child also uses Albuterol on a routine basis. follow up information form a registered nurse indicated that the patient was not a steroids at the time of vaccination or within 2 weeks before or after vaccinateion, It was reported that a specimen was obatined for analysis but was accidentally discarded. Subsequently, the patient completely recovered. Y Y 08/26/1996 04/11/2000 1324 OTH OTH albuterol Medical history: steroid therapy, concurrent conditions; asthma WAES00041276 1
0171213 06/01/2001 OH 3.0 1 .2 F 05/15/2001 Herpes Zoster - Information has been received from a registered nurse concerning a 41 month old female patient who on 17 Jan 1998 was vaccianted sc in the left arm with a first dose of varicella virus vaccine live (lot 624443/1106E). Concomitant therapy included a first dose sc in the right arm of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation Msd lot 0620E diluent vial and a fourth dose in the left thigh of HIb/Titer Lot M265RT. There were no illnesses at the time of vaccination. On 27 Mar 2000 the patient developed shingles. it was noted that the rash was located down her leg, on her lower abdomen, back and it stops at the midline and extends slightly to her groin. The patient was seen on two separate occasions in the physicians office and was afebrile at both visits. It was reported that the patient was treated with acetaminophen (-) codeine phosphate (tylenol - codenine for pain. follow up information from a physician reported that the patient developed a vesicular rash with an crythematous base at the waist line from the mid back around to abdomen on the right side, consistent with herpes zoster. On an unspecified date, the patient recovered. Y Y 01/07/1998 03/27/2000 810 PVT PVT UNk WAES00041384 1
0171214 06/01/2001 OH 1.0 F 05/15/2001 Injection site wheal, varicella - Information has been received from a pharmacist concerning a 1 year old female patient who on 01 Apr 2000 was vaccinated with varicella virus vaccine live. subsequently the patient experienced a red welt on the leg at the injection site which looks like a bug bite. the patient also developed pox on the face and a low grade fever. unspecified medial attention was sought. additional information has been requested. Y U 04/04/2000 OTH OTH UNk UNK WAES00041424 1
0171215 06/01/2001 NY 1.75 1 .0 F 05/15/2001 Herpes zoster, otitie - information has been received from a physican concerning a 19 month old female who on 30 aug 1999 was vaccinated with one dose of varicella virus vaccine live in the right arm (lot 630678/0426J) On 14 apr 2000 the patient was diagnosed with herpes zoster, there were a few hundred lesions along the T6 dermatome on the right side. The maximum temperature was 100 degrees f. there was no recent exposure to chickenpox or shingles. A specimen has been obtained for PCR analysis. The patient recovered. Follow up information reported that PCR analysis indicated that the specimen is positive for wild type VZV. Additonally, it was noted that the patient did not have a post vaccination rash within 42 days on the vaccine. The patient was seen in the physician's office on 15 May 2000 for an ear infection at which time the patient was fully recovered from the herpes zoster. Y Y 08/30/1999 04/14/2000 228 test: deoxyriponucimic acid, normal range: -, comment: pcr analysis positive for wild type vzv OTH OTH UNK UNK WAES00041536 1
0171216 06/01/2001 FL 6.0 5 M 05/15/2001 skin lesion - information has been received from a registered nurse concerning a 5 year old black male patient with a history of cutaneous fungal disease who on 24 apr 1998 was vaccinated with a second dose of varricella virus vaccine live in the left arm. concomitant therapy included amoxicillin trihydrate (+) clavulanate potassium (Augmentin). On 11 apr 2000 the patient presented with more than 100 lesions. half of which were on his face. there were also lesions on his back and stomach. the patient did not have a fever. follow up information from a registered nurse indicated that the patient was prescribed sulfadiazine silver salt (silvadene) cream. Subsequently, the patient recovered. Y Y 04/24/1998 04/11/2000 718 PVT PVT augmentin medical history: cutaneous fungal disease WAES00041563 1
0171217 06/01/2001 IL F 05/15/2001 Rash - Information has been received from a registered nurse concerning a female registered nurse who in 1999 was vaccinated with a first dose of varicella virus vaccine live SC. Subsequently, the patient developed a 10 cm raised, warm, swollen, painful rash. The nurse did not receive a second dose of varicella virus vaccine live. The nurse sought unspecified medical attention. Additional information has been requested. Y U 01/01/1999 OTH OTH UNK UNK WAES00041608 1
0171218 06/01/2001 CA 3.0 1 .0 F 05/15/2001 herpes simplex - information has been received from a physician concerning a 46 month old white female who on 16 Jun 1997 at the age of 12 months, was vaccinated with one dose of varicella virus vaccine live (site unknown) by another physician. On 17 Apr. 2000 the patient developed a mild case of chicken pox with lesions on the lower abdomen and back and was seen in the physician's office. the child had no fever and no other symptoms at the time of the report. follow up information received on 05 jun 2000 from a physician indicated that the patient was cultured and the result was herpes simplex 1, and not varicella as previously reported. follow up information received on 06 jul 2000 from a physician indicated that the culture finally grew herpes virus type 1 and thin was not related to the vaccine. no further information is expected. Y U 06/16/1997 04/17/2000 1036 Herpes simplex virus 04/17/00 Normal range (-) comment = culture grew herpes simplex 1 PVT OTH UNK UNK WAES00041612 1
0171219 06/01/2001 NJ 9.0 9 M 05/15/2001 Varicella - Information has been received from a physician concerning a 9 year old black male with no past medical history who on 30 mar 2000 was vaccinated with one dose of varicella virus vaccine live im in the left deltoid lot 632610/1854j. Concomitant therapy included vitamin dose unspecified. On 11 Apr 2000, the patient experienced breakthrough chicken pox with 13 lesions on his body. the reporter indicated that the patient developed a rash and had a total of 13 varicella like lesions. It was unknown whether the patient was exposed to mild type varicella before the vaccine. The patient was evaluated by a physician. On an unspecified date, the patient recovered. No further information is expected. Y Y 03/30/2000 04/11/2000 12 NONE OTH OTH vitamins NONE WAES00041632 1
0171220 06/01/2001 NY 1.3 1 .3 F 05/15/2001 skin lesion - Information has been received from a registered nurse concerning a 16 month old caucasian female patient who on 07 apr 2000 was vaccinated with a dose of varicella virus vaccine live sc in the right arm. concomitant vaccinations that same day included a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation msd sc in the left arm and a second dose of hoemophilum m conjugate vaccine lot number 412353a im in the right arm. On 17 apr 2000 the patient developed pustules secondary to varicella vaccine less than 60 lesions. The patient did not experience itching or a fever. The patient sought unspecified medial attention. Follow up information from a registered nurse indicated that the patient subsequently recovered. Y Y 04/07/2000 04/17/2000 10 PVT PVT UNk WAES00041640 1
0171221 06/01/2001 PA 15.0 15 F 05/15/2001 Injection site vesicle- information has been received from a physician concerning a 15 year old white female with attention deficit disorder with hyperactivity, mild mental retardation and micrencepaly who on 15 mar 2000 was vaccinated sc with the first dose of varicella virus vaccine live in the right arm. concomitant therapy included a third dose of hepatitits b vaccine, recomb (Engerix b. on 31 mar 2000 the patient devloped 2-3 vesicles at the varicella injection site. subsequently. the patient recovered from vesicles at injection site. no further information is available. Y 03/15/2000 03/31/2000 16 OTH OTH Concurrent Conditions: attention deficit disorder with hyperactivity mental retardation, micrancephaly WAES00041727 1
0171222 06/01/2001 MI M 05/15/2001 Lack 0f Response - Information has been received from a consumer concerning her son with asthma and possible allergies to ephedrine and tetracaine hydrochloride (pontacaine) who in December 1999 was vaccinated with the second dose of varicella virus vaccine live according to the recommended schedule. concomitant therapy included predocromil disodium (Tilade) and albuterol sulfate (Proventil). The patient sought medical attention and a titer showed that the patient did not convert. the patient's mother also had a similar experienced waes 000320941. no further information is available. Y U 12/01/1999 serum varicella zoster, Normal range (-), comment: lack of seroconversion UNK UNK proventil, tilace WAES00041765 1
0171223 06/01/2001 FL 1.8 1 .1 F 05/15/2002 Information has been received from a registered nurse concerning a 22 month old black female who on 07/24/99 was vaccinated with the first dose of varicella virus vaccine live in the left arm (lot 630407/0292J). Concomitant vaccinations included measles mumps rubella vaccine (Lot# 630407/0292J) and oral poliovirus vaccine. On 04/05/00, the patient developed small bumps on shoulder, back and legs. No further information is available. U 06/24/1999 04/05/2000 286 OTH OTH NKA WAES00041789 1
0171224 06/01/2001 AL 2.0 U 05/15/2001 Lack of Response- information has been received from a health care professional concerning a 2 year old patient who on 23 Oct 1998 was vaccinated withvaricella virus vaccine live. It was noted that on 16 oct 1998 the patient received a dose of measles- mumps - rubella vaccina (MSD) susequently the patient sought unspecified medical attention and was found to have a negative varicella titer. additional information has been requested. Y U 10/23/1998 serum varicella zoster , Normal Ranger (-), comment= negative titer, OTH OTH UNK WAES00041806 1
0171225 06/01/2001 TX 4.0 F 05/15/2001 Varicella: Secondary transmission: information has been received from a health care professional concerning her 4 year old daughter with codex allergy who on 08 Apr 2000 developed a fever. On 12 Apr 2000 and 13 Apr 2000 the patient's two brothers were vaccinated with one dose each of varicella virus vaccine live. serveral days after the start of her fever. the patient broke out in a rash. she sought medical attention and was diagnosed with chickenpox. Neither of the patient's vaccinated brothers experienced a rash or any other adverse experience. Follow up information received from a nurse at the physician's office reported that their office believes the patient was incubating wild type chickenpox at the time her brothers were vaccinated and that the fever was part of the prodomal phase of chickenpox. They did not believe that the patient's chickenpox had anything to do with her brothers vaccinations. No further information is available. Y U 04/08/2000 OTH OTH UNK varicella Concurrent Condition: allergy WAES00041810 1
0171226 06/01/2001 CO U 05/15/2001 Varicella - information has been received from a health care professional concerning a child who was vaccinated with one dose of varicella virus vaccine live. The patient subsequently developed a breakthrough case of varicella. The reporter stated that the child's varicella was not a severe case of breakthrough. No further information is available. UNK UNK UNK WAES00041891 1
0171227 06/01/2001 21.0 F 05/15/2001 Lack of Response - Information has been received from a health care professional concerning a 21 year old female patient who was vaccinated with the second dose of varicella virus vaccine live. The patient subsequently sought medical attention and a serum VEV antibody test revealed that she was soronegative. No further information is available. Y U serum varicella zoster, Normal range -, comment seronegative, UNK UNK UNK WAES00041003 1
0171228 06/01/2001 TX F 05/15/2001 Rash -Information has been received from a healthcare professional concerning a female child who was vaccinated with one dose of varicella virus vaccine live. It was noted that the patient had developed a varicella like lesion on the top of her head the day prior to vaccination. Within a few hours post vaccination, the patient broke out in a rash all over her body and was taken to the hospital. Y U OTH OTH UNK varicella -like rash UNK WAES00041920 1
0171229 06/01/2001 NJ 1.25 U 05/15/2001 Herpes Zoster- Information has been received from a physican concerning a patient who was vaccinated with the first and second dose of varicella virus live at ages 1 and 5 respectively. Subsequently the patient developed zoster. The reporting physician noted that the patient still had some post herpetic neuropathy and mild skin hypersensitivity. The patient was treated with acyclovir. Additional information has been requested. Y N OTH OTH UNK UNK WAES00041934 1
0171230 06/01/2001 NJ U 05/15/2001 varicella- Information has been received from a company representative concerning an unknown number of patients who were vaccinated with one dose of varicella virus vaccine live (unknown site) the reporter stated that a nurse practitioner informed him that the office recently has been seeing more breakthrough cases of chicken pox with the varicella virus vaccine live. an unspecified number of patient sought unspecified medical attention. Y N OTH OTH UNK WAES00041935 1
0171231 06/01/2001 TX U 05/15/2001 Information was received concerning several children that were vaccination with varicella live. The pt's developed a mild breakthrough varicella. It was reported that it appeared to be a wild type exposure. Additional information has been requested. U OTH OTH UNK UNK WAES00042058 1
0171232 06/01/2001 MN U 06/15/2001 Varicella - Information has been received from a company representative concerning several patients who approximately 1 to 2 years ago were vaccinated with one dose of varicella virus vaccine live (site unknown). On 20 Apr 2000. the patient have developed > 100 varicella lesions and a fever. It was noted that three of these patients are siblings. An unspecified number of patients sought unspecified medical attention. additional information has been requested. Y U 01/01/1995 04/20/2000 1936 OTH OTH UNK UNK WAES00042072 1
0171233 06/01/2001 NH 38.0 F 05/15/2001 Influenza- like disease; injection site reaction, migraine - information has been received from a registered nurse concerning a 38 year old female patient who on approximately 19 apr 2000 was vaccinated with a second dose of varicella virus vaccine live. On 20 apr 2000 the patient experiened flu like symptoms, a local injection site reaction that is red, swollen and the size of a quarter. It was noted that the patient also had a migraine headache. Unspecified medical attention was sought. Y U 04/19/2000 04/20/2000 1 OTH OTH UNK UNk WAES00042083 1
0171234 06/01/2001 NJ 4.0 4 M 05/15/2001 Varicella - Information has been received from a nurse practitioner concerning a 4 year old male patient with a history of varicella exposure who on 17 Apr 2000 was vaccinated with a fist dose of varicella virus vaccine live SC in the left arm. Concomitant vaccinations that same day included a second dose of measles mumps rubella vaccine (MSD) SC in the right arm, a fifth dose of diphtheria toxid (+) pertussis vaccine (+) tetanus toxoid Lot number: 40034ca im in the left thigh, and a fifth dose of poliovirus vaccine inactivated lot number f0905 im in the right thigh. On 20 apr 2000, the patient developed disseminated chickenpox. The patient's fater felt that his son may have been exposed to varicella at school where there had been an outbreak. The patient sought unspecified medical attention. Follow up information from a nurse practitioner indicated that subsequently. the patient recovered. Y Y 04/17/2000 04/20/2000 3 PVT PVT medical history; varicella exposure. WAES00042091 1
0171235 06/01/2001 5.0 U 05/15/2001 Varicella - Information has been received from a registered nurse concerning a 5 year old patient who in approximately April of 1999 was vaccinated with varicella virus vaccine live. On Approximatly 20 Apr 2000, the patient developed varicella. The patient sought unspecified medical attention. Follow up information from a registered nurse indicated that she does not have any additional information. Y U 04/01/1999 04/20/2000 385 OTH OTH UNK UNK WAES00042102 1
0171236 06/01/2001 MO 5.0 5 M 05/15/2001 Skin Lesion - Information has been received from a health care professional concerning a 5 year old male patient who on 10 Mar 2000 was vaccinated with one dose of varicella virus vaccine live. On approximatley 20 Apr 2000 the patient broke out with approximately 12 skin lesions. It was noted that the patient was afebrile. Unspecified medical attention was sought. Additional iformation has been requested. Y U 03/10/2000 04/20/2000 41 OTH OTH UNk UNK WAES00042126 1
0171237 06/01/2001 ME 28.0 29 F 05/15/2001 Exanthema, Chills, Myalgia, Pruritus - Information has been received from a physician concerning a 29 year old caucasian female patient who on 03 Apr 2000 was vaccinated with a first dose of varicella virus vaccine live sc in the left deltoid. On approximately 19 Apr 2000, the patient developed a generalized chickenpox rash with greater than 20 lesions. The patient sought unspecified medial attention. Follow up information from a physician indicated that the patient also experienced chills, myalgias, and pruritis and had greater than 50 papules. In addition the patient's laboratory results showed a varicella IgG 1.67 and varicella Igm 4. subsequently. the patient recovered. Y Y 04/03/2000 04/19/2000 16 diagnostic laboratory; normal range (-); comment - varicella IgG: 1.67: varicella IgM: 4 UNK UNK UNk WAES00042140 1
0171238 06/01/2001 RI U 05/15/2001 Varicella - Information has been received from a healthcare professional concerning 3 students ranging in ages from kindergarten to third grade who at unknown dates were vaccinated with a dose of varicella virus vaccine live site unknown. The reporter stated that in April 2000 a total of 7 students from one school. Including those that were vaccinated, had developed chicken pox. An undertemined number student sought unspecified medical attention. Also reprorted were 15 students from another school who were vacinated and experienced similiar events (waes 00041090). Y U 04/01/2000 OTH OTH unk unk varicella~Vaccine not specified (no brand name)~~0.00~In Patient WAES00042153 1
0171239 06/01/2001 IN 6.0 2 .0 F 05/15/2001 Varicella - Information has been received from a physician concerning a 6 year old female patient who on 25 sep 1995 was vaccinated with the first dose of varicella virus vaccine live (site unknown) on 21 apr 2000 the patient developed breakthrough chickenpox with vesicles noted on the patient's trunk. She sought unspecified medical attention. On an unspecified date the patient recovered. No further information is available. Y Y 09/25/1995 04/21/2000 1670 PVT PVT UNK UNK WAES00042321 1
0171240 06/01/2001 LA 7.0 F 05/15/2001 Exanthema - Information has been received from a health care professional concerning a 7 year old female patient who on 01 Jun 1997 was vaccinated with one dose of varicella virus vaccine live. On 20 Apr 2000 the patient developed a varicella rash with about 40 to 50 lesions and no fever. The patient sought medical attention. No further information is available. Y U 05/01/1997 04/20/2000 1085 UNK UNK UNK UNK WAES00042325 1
0171241 06/01/2001 MI 5.0 0 .2 F 05/15/2001 Varicella - Information has been received from a nurse practitioner concerning a 6 year old female patient who in approximately 1994 was vaccinated with the first dose of varicella virus vaccine live. In April of 2000. the patient developed a mild eruption of chickenpox. The patient sought unspecified medical attention. Follow up information from a nurse practitioner indicated that the patient subsequently recovered. No further information is available. Y Y 01/01/1994 04/01/2000 2282 UNK UNK WAES00042337 1
0171242 06/01/2001 MI 1.0 1 .0 M 05/15/2001 Varicella - Information has been received from a nurse practitioner concerning a 12 month old Caucasian male patient with an upper respiratory infection (afebrile) and benign macrocephaly who on 03 Apr 2000 was vaccinated with a first dose of varricella virus vaccine live sc in the left leg. Concomitant vaccination that same day included a first dose of mealses virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) MSD sc in the right leg. Concomitant medications included chlorpheniramine tannate (+) phenylephrine tannate (+) pyrilamine tannate rynatan. On 12 Apr 2000 the patient developed a mild case of varicella with less than 50 lesions and on the following day he was seen by a physician. Follow up information from a nurse practitioner indicated that the patient was seen on 27 Apr 2000 and 12 May 2000 and the lesion had resolved. Subsequently, the patient recovered. Y Y 04/03/2000 04/12/2000 9 UNK UNK Rynatan upper respiratory infection Concurrent Conditions: macrocephaly WAES00042340 1
0171243 06/01/2001 FL 5.0 5 M 05/15/2001 Varicella - Information has been received from a physician concerning a 5 year old while male who on 07 Apr 2000 was vaccinated with the first dose of varicella virus vaccine live lot 532370/14623 in the left arm . On 24 Apr 2000 the patient developed chicken pox with an unknown amount of lesions. The patient sought unspecified medical attention. On an unspeccified date. The patient recovered. Also reported was a female sibling who was vaccinated and experienced similar avents. No further information is expected Y Y 04/07/2000 04/24/2000 17 PVT PVT UNK UNK ~Vaccine not specified (no brand name)~1~7.00~In Sibling WAES00042367 1
0171244 06/01/2001 OH 1.0 M 05/15/2001 Varicella, Varicella - Information has been received from a nurse practitioner concerning a 1 year old male who in approximately 1996 was vaccinated with one dose of varicella virus vaccine live. Nine months after vaccination, the patient experienced a mild case of chickenpox with approximately 16 lesions. At five years of age. the patient experienced a full blown case of chickenpox, with approximately 20 lesions. It was noted this was only second day of virus. medical attention was sought. There was no fever. The patient was exposed to chickenpox in day care. Y U 01/01/1996 01/01/1996 0 OTH OTH UNK Concurrent conditions: varicella exposure WAES00042482 1
0171245 06/01/2001 WI 27.0 27 F 05/15/2001 Injection site rash: varicella - Information has been received from a registered nurse concerning a 27 year Caucasian female patient who on 12 Apr 2000 was vaccinated SC in the left arm with a first dose of varicella virus vaccine live (lot 632384/1728J) On 25 Apr 2000 the patient developed a mild case of chickenpox with amild low grade fever and pox lesions covering small portion of her back, arms and legs. It was also noted that the patient developed an injection site rash. Unspecified medical attention was sought. Follow up information from a registered nurse reported that on an unspecified date the patient recovered. No further information is expected. Y Y 04/12/2000 04/25/2000 13 none PVT OTH UNK UNK WAES00042470 1
0171246 06/01/2001 MA 2.0 1 .0 F 05/15/2001 Varicella - Information has been received from a nurse practitioner concerning a 29 month old female who on 05 Nov 1998 was vaccinated with one dose of varicella virus vaccine live (lot 627875/1245B. Concomitant therapy included one dose of measles-mumps-rubella vaccine (MSD). on 18 Apr 2000 the patient experieced varicella disease. Subsequently the patient recovered from varicella disease Y 11/05/1998 04/18/2000 530 PVT PVT UNK WAES00042490 1
0171247 06/01/2001 MA 3.0 1 .8 M 05/15/2001 Varicella - Information has been received from a nurse practitioner concerning a 3 year old caucasian male patient who on 05 Dec 1997 was vaccinated with a dose of varcicella virus vaccine live. On 12 Apr 2000 the patient developed varicella disease. Subsequently, the patient recovered. Additonal information has been requested. Y 12/05/1997 04/12/2000 859 OTH OTH UNK UNk WAES00042491 1
0171248 06/01/2001 FL 7.0 F 05/15/2001 Varicella - Information has been received from a medical assistant in a doctor's office concerning a 7 year old female who on 07 Apr 2000 was vaccinated with one dose of varicella virus vaccine live lot 632370/1462J site unknown. On 24 Apr 2000 the patient developed chicken pox with an unknown amount of lesions. The patient sought unspecified medical attention. Also reported was a male sibling who was vaccinated and experienced similar events (waes 000423367) Y U 04/07/2000 04/24/2000 17 OTH OTH UNk UNK ~Vaccine not specified (no brand name)~1~5.00~In Sibling WAES00042506 1
0171249 06/01/2001 MA 2.0 2 .2 F 05/15/2001 Constipation - Information has been received from a consumer concerning her 2 year old daughter with multiple food allergies who on 23 Apr 2000 was vaccinated with varicella virus vaccine live. The following day, the patient's mother indicated that her daughter was on a strict rotation diet. So she always knew what her daughter eats and she not eat anything different. but the day after vaccination, she was constipated. Additional information has been requested. U 04/24/2000 04/25/2000 1 OTH OTH UNK concurrent conditions; food allergy WAES00042510 1
0171250 06/01/2001 IN 0.75 F 05/15/2001 Varicella - Information has been received from a woman from a physician's office concerning a 9 mother old caucasian female who on 08 Apr 1995 was vaccinated with one dose of varicella virus vaccine live. On 13 Apr 2000 the patient experienced chickenpox. There were approximately 30 pox. some were crusted over. U 04/08/1996 04/13/2000 1466 PVT PVT UNK UNK WAES00042528 1
0171251 06/01/2001 WI 1.0 1 .1 M 05/15/2001 Rash: Swelling - Information has been received from a pharmacist concerning her 12 month old . Caucasian son who was vaccinated with varicella virus vaccine live. Approximately one week post vaccination, the patient developed a local reaction described as a large, red, raised rash. Follow up information from a physician reported that on 28 Feb 2000 the patient was vaccinated IM in the right upper with a first dose of varicella virus vaccinelive (lot 631480/1008J). There was no past medical history or illnesses at the time of vaccination. On 29 Feb 2000 the patient developed local swelling, quarter size red. On an unspecified date the patient recovered. Y 02/28/2000 02/29/2000 1 NOne PUB PUB UNK NONE WAES00042626 1
0171252 06/01/2001 MD 5.0 0 1 M 05/15/2001 Varicella, Cough - Information has been received from a health care professional concerning a 5 year old white male with sinusitis who on 15 Mar 1996 was vaccinated sc with one dose of varicella virus vaccine live (lot 612218/132hb) in the left arm. Concomitant therapy included cefprozil (cefzil). On 25 Apr 2000 the patient developed chicken pox with 30-40 itchy lesions scattered from head to toe, but with no blisters. The patient was noted as having the typical prodromal phase of cough and fever X 2 days. The patient sought unspecified medical treatment. On 28 Apr 2000 the patient recovered Y Y 03/15/1996 04/25/2000 1502 PVT PUB cefzil concurrent conditions: sinusitis WAES00042649 1
0171253 06/01/2001 PA 25.0 23 M 05/15/2001 Lack of Response - Information has been received from a health care professional concerning a 25 year old male medical student with dust. Mite leather, and mold allergies who on 31 Jul 1997 and 08 Oct 1997 was vaccinted with the first (17073 invalid lot number ) and second dose (lot 620626/1400d) of varicella virus vaccine live in the left and right upper arm respectively. Concomitant therapy included methlphenidate (ritalin). On 13 Apr 2000 lab work indicated a negative titer. On 12 May 200 the patient received a third dose of varicella virus vaccine live 632375/1340J Y U 10/31/1997 04/01/2000 883 diagnostic laboratory 04/13/00 (value unit- 0.41) (normal range 0.00 - 0.90) (comment - negative varicella antibody titer) PVT PVT ritalin Concurrent Conditions: allergy; dust allergy; mite allergy; mold allergy WAES00042664 1
0171254 06/01/2001 CA U 05/15/2001 Varicella - Information has been received from a woman in a pediatrician's office concerning multiple patients who were vaccinated with varicelle virus vaccine live (site unknown). Subsequently the patients developed breakthrough varicella post vaccination. The patients did not seek medical attention. It was noted unclear if it could be a storage problem. U OTH OTH UNK UNK WAES00042699 1
0171255 06/01/2001 GA 5.0 F 05/15/2001 Exanthema, Fever - Information has been received from a physician concerning a 5 year old female who four years ago, in approximately 1996, was vaccinated with one dose of varicella virus vaccine live (unknown site ) On 26 Apr 2000, the patient developed a varicella like rash with less than 20 lesions and a slight fever. The patient sought unspecified medical attention. Follow up information from the physician indicated that this was not an adverse reaction because the patient had less than 50 lesions and it was uncomplicated. No further information is expected. Y U 01/01/1996 04/25/2000 1576 OTH OTH UNK UNK WAES00042702 1
0171256 06/01/2001 1.0 M 05/15/2001 Exanthema - Information has been received from a licensed practical nurse concerning a 12 month old male who on 17 Apr 2000 was vaccinated with one dose of varicella virus vaccine live (site unknown). On 27 apr 2000 the patient developed a generalized varicella like rash. The reported also noted that the patient's mom is 5 months pregnant. The patient sought unspecified medial attention. Y U 04/17/2000 04/27/2000 10 OTH OTH UNK UNk WAES00042773 1
0171257 06/01/2001 CA 7.0 M 05/15/2001 Varicella - Information has been received from a registered nurse concerning a 7 year old male who at the age of 3 was vaccinated with one dose of varicella virus vaccine live (unknown site ). on 27 apr 2000. the reporter indicated that the patient has now developed varicella with < 100 lesions. The patient sought unspecified medical attention. Also reported was the patient's sister who was vaccinated and experienced a similar event (wases 00051832) Y U 01/01/1996 04/27/2000 1578 OTH OTH UNK UNk ~Vaccine not specified (no brand name)~~5.00~In Sibling WAES00042793 1
0171258 06/01/2001 GA U 05/15/2001 Varicella - Information has been received from a healthcare professional concerning a child who on 14 May 1998 was vaccinated with one dose of varicella virus vaccine live. Subsequently the patient experienced chickenpox. Medical attention was sought. Three other patients had a similar experienced following vaccination with varicella virus vaccine live (waes 00061181-00061183). Y U 05/14/1998 OTH OTH UNK UNK WAES00042794 1
0171259 06/01/2001 NY 9.0 7 M 05/15/2001 Varicella - Information has been received from a health care professional concerning a 9 year old caucasian male patient who on 19 Sep 1997 was vaccinated in the left arm with a first dose of varicella virus vaccine live (lot 623555/0691E. There were no concomitant medications, allergies or past medical history. On 26 Apr 2000 the patient experienced a mild form of chicken pox. On an unspecified date the patient recovered. Y Y 09/19/1997 04/26/2000 950 UNK UNK NONe WAES00042802 1
0171260 06/01/2001 TX 7.0 2 .5 M 05/15/2001 Varicella - Information has been received from a licensed visiting nurse concerning a 7 Year old caucasian male patient who on 21 Jun 1995 was vaccinated with first dose of varicella virus vaccine live sc. There was no concomitant medication. On 26 Apr 2000, The patient was diagnosed with varicella. The number of lesions was not documented and the patient was afebriale. Follow up information from a licensed visiting nurse indicated that nearly every student in the patient's class had chickenpox. The patient had chickenpox for only 2 and a half days without; fever. The patient's twin sibling and older sibling never developed symptoms. Additional information has been requested. Y U 06/21/1995 04/26/2000 1771 PVT PVT NONE Concurrent Conditions; Varicella exposure WAES00042820 1
0171261 06/01/2001 TX 5.0 1 .0 F 05/15/2001 Varicella - Information has been received from a licensed visiting nurse concerning a 5 year old female who on 19 Jun 1995 was vaccinated sc with one dose of varicella virus vaccine live. There was no concomitant medication. On 27 Apr 2000 the patient experienced chickenpox. Medical attention was sought. Y U 06/19/1995 04/27/2000 1774 OTH OTH NONE UNK WAES00042823 1
0171262 06/01/2001 CA 10.0 6 M 05/15/2001 Rash - Information has been received concerning a 10 year old caucasian male who on 05 mar 1996 was vaccinated with one dose of varicella virus vaccine live in the right thigh. On 18 Apr 2000 the patient experienced a rash with approximately 50 lesions. The rash was not very itchy and scabbed over quickely. On 21 Apr 2000, the patient recovered from the rash. Y 03/05/1996 04/18/2000 1505 PVT PVT UNK UNk WAES00042843 1
0171263 06/01/2001 MN 6.0 4 M 05/15/2001 Varicella - Information has been received from a nurse practitioner concerning a 6 year old caucasian male patient with a history of right otitis media who on 19 Nov 1987 was vaccinated with a first dose of varicella virus vaccine live in the left arm. On 05 apr 2000, the patient was diagnosed with varicella. It was indicated that on 19 Nov 1997 the patient was prescibed mulfamethoxazole (+) trimethoprim. Bactrim 200 mg bid for 10 days for right otitis media Y Y 11/19/1997 04/05/2000 868 PVT PVT Bactrim Medial history: otitis media WAES00042654 1
0171264 06/01/2001 CA 1.08 1 .1 M 05/15/2001 Lack of Response- Information has been received from a physician concerning a 13 month old male patient with a history of reactive airway disease who on 21 Jul 1998 was vaccinated with a first dose of varicella virus vaccine live (lot 626689/0651H) sc in the right upper arm. Concomitant vaccinations that same day included a first dose of mealses - mumps-rubella vaccine. Priorix as part of a clinical study. sc in the left upper arm 1st number 1091. additional concomitant therapies included acetaminophen tylenol, cefixime suprax, and albuterol. It was reported that fever, otitis media, reactive airway disease, and an upper respiratory infection were illnesses at the time of vaccination. With in 42 days of vaccination. On approximately 02 sep 2000, the patient's laboratory results indicated a lack of seroconversion. Additional information has been requested. Y U 07/23/1998 09/27/2000 797 serum varicella zoster 09/27/00 (normal range - ) ( comment- did not serovonvert) PVT OTH tylenol, albuterol, suprax Fever; otitis med reactive airway disease, upper respiratory infection Medical History: reactive airway disease WAES00042857 1
0171265 06/01/2001 VA 10.0 7 F 05/15/2001 Blister - Information has been received from a physician concerning a 10 year old female patient who on 20 Sep 1996 was vaccinated sc in the left upper arm with varicella virus vaccine live. Concositant therapy included brompheniramine malcate (+) phenylpropanolam (dimetapp) for allergic rhinitis and post nasal drainage at the time of vaccination. On 23 apr 2000 the patient developed two small pin head size vesicles with a base of erythema over her abdomen on two separate locations. there were a total of four vesicles which lasted for 2 weeks. The patient is recovered. No further information is avaiable. Y 09/20/1996 04/23/2000 1311 PVT PUB dimetapp allergic rhinitis; postnasal drip Concurrent Condition: allergic rhinitis, postnasal drip WAES00042658 1
0171266 06/01/2001 TX 4.0 F 05/15/2001 Emanthema; Herpes Zoster - Information has been received from a physician concerning a 4 year old female who in approximately 1997 was vaccinated with one dose of varicella virus vaccine live. There was no concomitant medication. On approximately 28 Mar 2000 the patient experienced a chickenpox like rash with approximately ten lesions. in april 2000 she experienced a zoster like rash that was red and inflamed with some cantral clearing and blistering. The zoster like rash was located to the left upper thigh. she was administered cetirizine dihydrochloride zyrtec and triamcinoline acetonide kenalog. Y U 01/01/1997 03/26/2000 1180 OTH OTH NONe UNK WAES00050040 1
0171267 06/01/2001 TX 2.0 F 05/15/2001 Herpes Zoster - Information has been received from a physician concerning a 2 year old female patient who was vaccinated with varicella virus vaccine live at approximatley 1 year of age. Subsequently, the patient developed shingles. By the time the patient was seen by a physician, the shingles had resolved. Additonal information has been requested. Y Y OTH OTH UNK UNK WAES00050054 1
0171268 06/01/2001 NY 27.0 26 F 05/15/2001 Cellulitis, Injection site mass; pruritus; rash - Information has been received from a 27 year old female concumer who on approximatley 06 Apr 2000 was vaccinated with varicella virus vaccine live. There was no concomitant medication. Two and half weak post-vaccination, the patient developed an injection site reaction described as up to a 3 inch diameter swollen purple mass. The patient went to a physician who prescribed penicillin and a corticosteroid to help the swelling, but she was unable to take the medication. Subsequently, the patient broke out with a blotchy skin rash all over her body that was itchy. It was a very atypical rash, and now her physicain is not willing to administer a second dose of varicella virus vaccine live. Follow up information from a registered nurse indicated that the patient's chart stated the patient's experience was questionable cellulticis, and that prior to administering the second dose of varicella virus vaccine live, the physician wanted to check the patient's varicella titer. In addition, the physician indicated that this was not a very severe reaction. It was not known if the patient recovered. Additional information has been requested. Y U 04/05/2000 04/20/2000 15 OTH OTH NONE UNK WAES00050164 1
0171269 06/01/2001 OH M 05/15/2001 Varicella - information has been received from a registered nurse concerning a male child who on 27 apr 2000 was vaccinated with one dose of varicella virus vaccine live (unknown site). On 01 May 2000 the patient developed varicella. The patient sought unspecified medical attention. Additional information has been requested. Y U 04/27/2000 05/01/2000 4 OTH OTH UNK UNK WAES00050179 1
0171270 06/01/2001 RI 2.0 0 1 M 05/15/2001 Varicella, Vomiting - Information has been received from a health care professional concerning a 25 month old Caucasian male patient who on 17 Feb 1999 was vaccinated sc in the left arm with a first dose of varicella virus vaccine live (lot 628243/1340K). It was noted that there were no illnesses at the time of vaccination and no past medical history. On 12 Apr 2000 the patient developed 10-20 varicella lesions with a 17 Apr 2000. On 14 Apr 2000 the patient experienced vomiting with a fever. Unspecified medial attention was sought. The patient's fever was treated with acetaminophen (tylenol) and he was placed on a clear liquid diet. follow up information received from a health care professional reported that on 18 Apr 2000 the patient recovered. Y Y 02/17/1999 04/12/2000 420 PVT OTH UNK WAES00050230 1
0171271 06/01/2001 NH 10.0 10 F 05/15/2001 Varicella - Information has been received from a physician concerning a 10 year old white female who on 18 apr 2000 was vaccinated with the first dose of varicella virus vaccine vaccine live sc in the left deltoid lot 631065/0445J. the reporter stated that on 19 apr 2000. the patient was exposed to the wild type varicella by her brother who had developed wild type chicken pox and chicken pox is going through the local school right now. On 30 apr 2000 the patient developed chicken pox with a total of 15-20 lesions. the patient sought unspecified medical attention and recovered on 08 may 2000. also reported was the patient's sister who was vaccinated and experienced similar events (waes 0005029). No further information is expected. Y Y 04/18/2000 04/30/2000 12 PVT OTH concurrent condition: varicella exposure ~Vaccine not specified (no brand name)~1~7.00~In Sibling WAES00050236 1
0171272 06/01/2001 CA 14.0 F 05/15/2001 Parestheris: pain - Information has been received from a physician concerning a 14 year old female patients who in approximatley 1999 was vaccianted with varicella virus vaccine live. On approximately 29 Apr 2000 the patient began to experienced prodromal symtoms of burning in T9 and t10 area. At the time of reporting no rash was present it was noted that the patient feels sunburn and her skin is tender to the touch. unspecified medial attention was sought. Y U 01/01/1999 04/29/2000 484 OTH OTH UNK UNk WAES00050239 1
0171273 06/01/2001 PA 7.0 3 F 05/15/2001 varicella - Information has been received from a consumer concerning her 7 year old daughter with an amoxicillin allergy who on 29 Feb 1996 was vaccine vaccinated with one dose of varicella virus vaccine live (site unkown). On 28 apr 2000 the patient developed a mild case of chickenpox with approximately 30 plus pox on the back, chest, arms, legs, foot and forehead. She presented to a pediatrician's office that same day and was treated with diphenhydramine HCL (Benadryl). She was uncomfortable on that day, but was playing normally on 29 apr 2000 and 30 apr 2000 she did not attend school on 01 may 2000. follow up information received from a physician indicated that on 20 apr 2000 the patient developed mild chicken pox with less than 50 vesicular, pruritic lesions. On an unspecified date, the patient recovered. no further information is expected. Y Y 02/29/1996 04/28/2000 1520 PVT PVT UNK concurrent conditions; amoxicillin allergy WAES00050250 1
0171274 06/01/2001 NH 7.0 7 F 05/15/2001 Varicella - Information has been received from a physician concerning a 7 year old white female who on 18 Apr 2000 was vaccinated with the first dose of varicella virus vaccine live sc in the left deltoid lot 631065/04453 . The reported stated that on 19 Apr 2000 the patients was exposed to wild type varicella by her brother who had devloped wild type chicken pox and chicken pox is going through the school right now. On 10 Apr 2000 the patient developed chicken pox with multiple lesion (> 100) with fever for 2 days. the patient sought unspecified medical attention on 10 may 2000 the patient recovered. also reported was the patients sister who was vaccinated and experienced similar evernts (waes 00030236.) Y Y 04/18/2000 04/30/2000 12 PVT PUB UNK concurrent conditions: varicella exposure ~Vaccine not specified (no brand name)~1~10.00~In Sibling WAES00050291 1
0171275 06/01/2001 ME 1.75 1 .0 M 05/15/2001 Varicella - Information has been received from a registered nurse concerning a 21 month old male patient who on 23 Jul 1999 was vaccianted with one dose of varicella virus vaccine live (lot 629263/0308J). There were no concomitant therapies. On 14 apr 2000 the patient broke out with chickenpox lesions. approximately 30 on the first day. On an unspecified date, the patient recovered for chichenpox without any prescription drug treatment. Y 07/23/1999 04/24/2000 276 UNK UNK NONE UNK WAES00050312 1
0171276 06/01/2001 VA 2.0 2 .4 F 05/15/2001 Varicella - Information has been received from a physician concerning a 2 year old female with no medical history who on 07 Apr 2000 was vaccinated with one dose of varicella virus vaccine live. There was no concomitant medication. Subsequently the patient experienced a mild case of chickenpox consisting of 3-4 pox, 2 acabs, one vesicle, and one papule. Medical attention was sought. Y U 04/07/2000 OTH OTH NONE UNK NONE WAES00050364 1
0171277 06/01/2001 KY 4.0 1 .5 M 05/15/2001 Varicella - Informaion has been received from a registered nurse concering a 4 year old caucasian male with allergies to amoxicillin (Amoxil) and cefaclor (Ceclor) who on 15 Dec 1996 was vaccianted SC in the right arm with a first dose of varicella virus vaccine live lot 616998/1658B. Concomitant therapy included methyiphenidate (hitalin) 5mg and weekly allergy shots. On 20 Apr 2000 the patient broke out with chickenpox consisting of more than 25 pruritic lesions. The patient was febrile. Unspecified medical attention was sought. The patient's brother (waes 00050668) had a similar experience following exposure to varicella virus vaccine live. Follow up information from a registered nurse reported that the patient was seen in the physician's office on 24 apr 2000 at which time the vesicles had acabbed Y N 12/19/1996 04/20/2000 1218 PVT PVT Concurrent conditions: caclor allergy: amoxicillin allergy ~Vaccine not specified (no brand name)~~2.00~In Sibling WAES00050383 1
0171278 06/01/2001 1.0 F 05/15/2001 Vesiculobulloous Rash, Injections site rash - Information has been received from a consumer concerning a 12 month old female family member with a history of gastic irritation after vaccianteion with the rotavirus vaccine who was vaccinated with one dose of varicella virus vaccine live in the right thigh. Subsequently the patient developed a blister like rash on the forehead and chest. There were two bilister at both of these sites. At the injection site a dark pink reaised rash developed that was similar to the rash seen on the other parts of the body. the patient sought unspecified medical treatment. Y U OTH OTH UNK medical history: gastric irritation WAES00050472 1
0171279 06/01/2001 ND 24.0 24 F 05/15/2001 arm pain, rash, pruritus, skin warm to touch, exanthmea - Information has been received from a health care professional concerning a 24 year old white female with a latex allergy who on 03 or 04 Apr 2000 was vaccianted with one dose of varicella virus vaccine live (site unkown). Subsequently the patient developed a 15 mm erythemic rash a few days before the 17 th. there were also 2 smaller pox like rashes inside the larger rash, the smaller pox like rashes itched, there was no blistering, weeping or scarring, the area was warm to touch and sore. the rash went away in approximately 5 days after onset. the patient sought unspecified medial treatment. subsequently, the patient recovered from the erythmic rash. Y Y 04/03/2000 04/15/2000 12 PUB OTH UNK Concurrent Conditions: latex allergy WAES00050500 1
0171280 06/01/2001 MO 6.0 5 F 05/15/2001 varicella - information has been received from a physician concerning a 6 year old caucasian female who on 27 jul 1998 was vaccinated sc with one dose of varicella virus vaccine live lot 625044/1568e site unknown. on 03 may 2000 the patient developed a mild case of chicken pox that consisted of 1 vesical and less than 10 lesions. the patient was noted to be playing in a field and her mother found two small sores in her hair. they ere originally thought to be bug bites. After approximatley 3 days more lesions were noted on the right cheek right elbow and lower left leg. the patient remained afebrile. a diagnosis of chicken pox was made however lesions did not appear typical none of the areas blistered. on an unspecified date. the patient recovered no futher information is expected. Y Y 07/27/1998 05/03/2000 646 PVT PVT UNK UNK WAES00050512 1
0171281 06/01/2001 PA 1.0 1 .0 F 05/15/2001 Varicella - Information has been received from a registered nurse concerning a 12 month old hispanic female patient with no pre existing allergies or medical conditions who was vaccinated with a first dose or varicella virus vaccine live on 25 apr 1999 sc in the right arm. On 03 may 2000 the patient developed several vesicular lesions on her trunk mostly in the diaper area with no fever, the patient sought unspecified medical attention follow up information from a registered nurse indicated that on 04 may 2000 the patient mother indicated that the patient developed approxmiately 60 vesicles from head to toe. it was determined that the patient had a case of chickenpox . Y Y 04/25/2000 05/03/2000 8 PVT PUB UNK None WAES00050568 1
0171282 06/01/2001 TX F 05/15/2001 Ophthamlic trauma- Information has been received from a female consumer who is a registered nurse with allergies and asthma. On an unspecified date, the patient had an eye splash with varicella virus vaccine live while trying to administer the vaccine. concurrent medications include many medications. The patient sought unspecified medical attention Y U OTH OTH UNK concurrent condition: allergy, asthma. WAES00050614 1
0171283 06/01/2001 CO 5.0 5 M 05/15/2001 Varicella - Information has been received from a physician concerning a 5 year old Hispanic male with a penicillin and amoxicillin allergy who on 26 Apr 2000 was vaccinated sc with one dose of varicella virus vaccine live (lot 632612/1851J) in the left arm. Concomitant vaccinations that same day included one dose of herpatitis a virus vaccine (msd) lot 632779/1259J). On 02 May 2000 the patient developed a rash with approximatley 10 lesions that appeared to be chicken pox. The patient sought unspecified medical treatment. On 15 may 2000 the patient recovered. no further inforamtion is available. Y Y 04/26/2000 05/01/2000 5 OTH PVT Concurrent Conditions: amoxicillin allergy: penicillin allergy WAES00050627 1
0171284 06/01/2001 OH 2.0 1 .1 M 05/15/2001 ekanthema, pharyngitis - Information has been received from a registered nurse concerning a 26 month old caucasian male patient with no known allergies and bilateral otitis media at the time of vaccination who on 25 Feb 1999 was vaccianted sc in the right arm with a first dose of varicella virus vaccine lot (lot 628242/1942H). Comcomitant therapy included a first dose sc in the left arm of mealses mumps rubella vaccine (msd) lot 1850N- invalid and azithromycin (zithromax). on 24 Apr 2000 the patient developed a varicella type rash and pharyngitis. The patient was seen in the physician's office on 26 Apr 2000. The patient recovered on an unspecified date. No further information is expected. Y Y 02/25/1999 04/24/2000 424 UNK UNK zithromax otitis media UNK WAES00050655 1
0171285 06/01/2001 KY 2.0 M 05/15/2001 varicella - information has been received from a registered nurse concerning a 2 year old male patient with allergies to azathloprine (Zithromax) who on 13 apr 1999 was vaccinated with one dose of varicella virus vaccine live (lot 628524/1657h) Concomitant therapy included polymyxin B sulfate (+) trimethoprim (Polytrim). The patient was exposed to his brother (waes 00050383) who developed varicella on 18 Apr 2000. It was noted that the patient subsequently broke out with chickenpox. The patient was febrile and had greated than 25 pruritic lesions. unspecified medical attention was sought. Additional information has been requested. Y U 04/13/1999 04/19/2000 372 UNK UNK polytrim concurrent conditions: antibiotic allergy: varicella exposure ~Vaccine not specified (no brand name)~~4.00~In Sibling WAES00050668 1
0171286 06/01/2001 AL 1.8 1 .0 F 05/15/2001 Herpes Zoster- Information has been received from a health care professional concerning a 22 month old female patient who on 07 Jul 1999 was vaccinated in the left arm with one dose of varicella virus vaccine live (25580/1538E-invalid). There were no concomitant medications, known allergieis or past medial history. The patient did not have a post vaccination rash within 42 days of the vaccination. On 05 May 2000 the patient presented to a physician's office with what was said to appear like shingles. The rash was located on C4, C5, C6 and all the median nerves on the right arm, involving the entire shoulder. The patient was reportedly fussy. The registered nurse quantified the patient's pain as 7 on a scale of 1-10 (worst) and descrived the herpes zoster as pretty had. It was noted that the patient was afebrile and was treated with diphenhydramine hydrochloride (Bendadryl) and acyclovir po and has recovered. Follow up information reported that preliminary results of pcr analysis from columbis university are vzv positive. Follow up information reported that the final results of the PCR analysis obtained on 08 May 2000 from Columbia University were VZV + and Oka VZV was identified on PCR analysis. Y Y 07/07/1999 05/05/2000 303 test: deoxyribomicleic acid, normal range -, comment preliminary pcr analysis results are vzv (+), test deoxyribonuclesic acid 05/08/00 , normal range -, comment final pcr analysis result vzv (+) & oka vzv identified. UNK UNK NONE NONE WAES00050690 1
0171287 06/01/2001 IN 27.0 F 05/15/2001 Skin Lesion - Information has been received from a physician concerning an approximately 27 year old female patient who was vaccinated with varicella virus vaccine live. Three years post-vaccination, the patient developed approximately 15-20 lesions. The patient sought unspecified medical attention. Additonal information has been requested. Y U OTH OTH UNK UNK WAES00050736 1
0171288 06/01/2001 AZ 6.0 3 F 05/15/2001 Skin Lesion, Fever, Pruritus - Information has been received from a registered nurse concerning a 6 year old Caucasian female patient who on 13 Aug 1996 was vaccinated sc in the left arm with a first dose of varicella virus vaccine live (lot 617077/02490). There were no concomitant modications, past medical history of illneses at the time of vaccination. On 04 May 2000 the patient developed approximately 40 scattered papular lesions, pruritus and a low grade fever. Follow up information from a regisitered nurse reported that on an uspecificed date the patient recovered. Y 08/13/1996 05/04/2000 1360 NONE PVT PVT NONE WAES00050763 1
0171289 06/01/2001 GA 6.0 U 05/15/2001 Varicella - Information has been received from a physician concerning a 6 year old patient who on 30 July 1998 was vaccianted with varicella virus vaccine live. At the end of April of 2000, the patient developed chickenpox. It was indicated that this seemed to be a mild case of chickenpox, but the office only saw the patient in the beginning of the breakout. An additonal patient (waes 00051071) had a similar experience following exposure to varicella virus vaccine live. Additional information has been requested. Y U 07/30/1998 04/01/2000 611 OTH OTH UNK UNk WAES000050771 1
0171290 06/01/2001 NY 4.0 5 M 05/15/2001 Varicella - Information has been received from a physician concerning a 4 year old male patient with no medical history of allergies who on 12 Apr 2000 was vaccinated with a 0.5 cc dose of varicella virus vaccine live in the left leg. Concomitant vaccinations that same day included a dose of diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid in the left leg. On 19 Apr 2000, the patient developed with rash at the injection site that included swelling and an unknown number of vesicles. On 26 Apr 2000 the patient presented to a physician with varicella with swelling and crusted vesicles. A dry, crusted vesicle was obtainted for PCR analysis at columbia University and the preliminary result was found to be VZV positive. Subsequently, the patient recovered. Follow up information from a laboratory indicated that the isolated speciment analyzed via pcr was found to be OKA/Vaccine strain. Additional information has been requested. Y Y 04/12/2000 04/19/2000 7 test; deoxyribonucleic acid date 04/26/00, normal range -, comment columbia university, pcr analysis- positive for oka/vaccine strain. OTH OTH NONE WAES00050804 1
0171291 06/01/2001 OH 19.0 19 F 05/15/2001 Hip Disorder - Information has been received from a physician and a nurse throught the pregnancy registry for varicella virus vaccine live concerning a 19 year old female who on 04 Apr 2000 was vaccinated with one dose of varicella virus vaccine live (Site unknown). Concomitant medication included prenatal vitamins (composition unspecified). The reporter indicated that the patient was about 14 days pregnant on the date of vaccination and the date of her last mentrual period was 04 Mar 2000. However, contradictory information received from the patient indicated that the patient received the vaccination on 03 Apr 2000 and that she was about 3 months pregnant at the time of vaccination. Follow up information received on 05 Jun 2000 from a nurse, confirmed that the date of the patient's last menatrual period was documented as 04 Mar 2000. The reporter also stated that the patient had an ultrasound on 11 May 2000 which verified an intrauterine pregnancy of 9 Weeks plus 1 day gestation which was consistent with the recorded date of the last mentrual period. On 12 Nov 2000 the patient had a spontaneous rupture of membranes at 35 weeks and 2 days gestation and gave birth to a normal female baby weighing 2892 grams. At the time of birth, no congenital anomalies were noted. The patient had well child visit at two weeks, one months and two months. On 16 Jan 2001, at the two month visit, a physical exam was performed which was normal except that bilateral hip clicks were noted. the physician's plan at this time was to perform an ultrasound in order to rule out dysplasia. Y U 04/04/2000 01/16/2001 287 test: ultrasound date 05-11-00, normal range -, comments results intrauterine pregancey of 9 weeks plus 3 day gestation OTH OTH vitamins concurrent conditions: pregnancy (Lmp - 3/4/00 WAES00050810 1
0171292 06/01/2001 NE U 05/15/2001 Varicella, Lack of Response- Information has been received from a woman in a hospital concerning a patients who were vaccinated at an unspecified date with one dose of varicella virus vaccine live (Site unknown) lot 608667/0426B). Subsequently, the patients developed vaccine failure which was described as mild disease. An unspecified number of patients sought unspecified medial attention. It was reported that the pahysician had requested all receipients of this lot to be revaccinated. Additional information has been requested. Y U OTH OTH UNK UNK WAES00050843 1
0171293 06/01/2001 NJ 1.0 1 .0 M 05/15/2001 Hypomelanosis - Information has been received from a company representative concerning a 12 month old white male who on 09 Mar 2000 was vaccinated with a first dose of varicella virus vaccine live sc in the left arm. Concomitant vaccinations that same day included a third dose of hepatitis B vaccine recombinant (Engerix B) Im in the left thigh (lot number: 2919A2). Three weeks post-vaccination, the patient experienced hypopigmentation and sought unspecified medical. Follow up information from a physician indicated that a patch was noticed 3 week post vaccination. A hypopigmented area was noted on left arm at injection site were the varicella virus vaccine was given. it was reported that the patient was seen for observation on 05 May 2000 and on 13 Jun 2000. Additional information has been requested. Y U 03/09/2000 03/30/2000 21 OTH OTH UNK WAES00050666 1
0171294 06/01/2001 MT F 05/15/2001 Skin Lesion - Information has been received from a health care professional concerning an approximately 4-5 year old female with no significant medical history who on 03 Apr 2000 was vaccianted sc with one dose of varicella virus vaccine live (site unknown). On 13 Apr 1000 the patient developed approximatley 10 pox like lesions around her waist a pox like rash, not herpes zoster. The lesions were noted to have gone away and every few days she breaks out with a few more which subsequently disappear. The patient sought unspecified medical treatment. Additional information has been requested. Y U 04/03/2000 04/13/2000 10 OTH OTH UNk UNK WAES00050892 1
0171295 06/01/2001 MD 7.0 7 F 05/15/2001 Cough, Fever - Information has been received from a health care professional concerning a 7 year old female with a history of a rash after vaccination with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (Waes 00032638) who on 27 Mar 2000 was vaccinated with a second dose of varicella virus vaccine live (site unknown). On 03 Apr 2000 the patient developed a possible reaction described as fever and cough. Additional information has been requested Y U 03/27/2000 04/03/2000 7 UNK UNK medical history; rash rash~Measles + Mumps + Rubella (no brand name)~~0.00~In Patient WAES00051059 1
0171296 06/01/2001 GA 4.0 U 05/15/2001 Varicella - Information has been received from a physician concerning a 4 year old patient who on 24 Aug was vaccinated with varicella virus vaccine live. At the end of April of 2000, the patient developed chickenpox. It was indicated that this seemed to be a mild case of chickenpox, but the office only saw the patient in the beginning of the breakout. An additional patient waes 00050771 had a similar experience following exposure to varicella vaccine live. Additonal information has been requested. Y U 08/26/1996 04/01/2000 1314 UNK UNK UNK UNK WAES00051071 1
0171297 06/01/2001 GA 4.0 4 F 05/15/2001 Varicella - Information has been received from a registered nurse concerning a 4 year old female who on 09 May 2000 was vaccianted with one dose of varicella virus vaccine live. On 10 May 2000 the patient experienced chickenpox. The patient had blisters on her foot which lthe patient's mother had assumed were caused by shoes. The patient had been exposed to chickenpox at school then days prior to vaccination. Unspecified medical attention was sought. Follow up was received which indicated this did not appear to be an adverse reaction to varicella virus vaccine live. Y U 05/09/2000 05/10/2000 1 OTH OTH UNK Concurrent Conditions: varicella exposure WAES00051093 1
0171298 06/01/2001 NY U 05/15/2001 Lack of Response - Information has been received from a physician concerning several patients who were vaccinated with two dose of varicella virus vaccine live. Subsequent laboratory evaluation revealed a lack of response. U test; serum varicella zoster, normal range -, comment negative after 2 doses OTH OTH UNK UNK WAES00051097 1
0171299 06/01/2001 MA 2.0 1 .0 F 05/15/2001 Varicella - Information has been received from a registered nurse concerning a 32 month old female caucasian patient with no known allergies or medical history who on 17 Aug 1998 was vaccinated subcutaneously via the left anterior thigh with a frist dose of varicella virus vaccine live. Concurrent vaccinations that same day included a fourth dose of haemophilus B conjugate vacccine lot number m260rj given intramuscularily via the left thigh and a first dose of mealses virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (msd) given subscutaneously via the right anterior thigh. On 05 May 2000 the patient developed varicella after being exposed to two of her siblings with active varicella who were not vaccinated. The nurse reported that the patients' varicella was not mild. The patient was not seen by a health care provider. The patient's father stated that the patient was covered. It was estimated that there were greater than 100 lesions. Follow up information was received from a registered nurse who indicated that the patient developed multiple lesions and was febrile, otherwise doing fine. The patient was treated with acetaminophen(tylenol) diphenhydramine hydrochloride (Benadryl, and aveeno baths, Subsequently the patient recovered. Y 08/17/1998 05/05/2000 627 body temp 05/05/00 , normal range -, comment febrile PVT PVT concurrent condition; Varicelia exposure WAES00051108 1
0171300 06/01/2001 PA 6.0 5 M 05/15/2001 Varicella - Information has been received from a health care profesional concerning a 6 year old male patient who on 21 Oct 1999 was vaccinated sc with a first dose of varicella virus vaccine live (lot 631479/1007J) There was past medical history of illnesses at the time of vaccination. On 08 May 2000 the patient developed macular red lesions on his buttock and thigh. There was positive blanching with no scabs or vesicles noted. The case was reported as questionable atypical varicella. Unspecified medial attention was sought. It was noted that the patient had been exposed to variecella two weeks prior to the rash. The patient's two borther weas 00051544/0051545 had a similar experienced following exposure to varicella virus vaccine live Y Y 10/21/1999 05/08/2000 200 UNK UNK Medical History; varicella exposure ~Vaccine not specified (no brand name)~~3.00~In Sibling|~Vaccine not specified (no brand name)~~4.00~In Sibling WAES00051141 1
0171301 06/01/2001 PA 3.0 1 .3 M 05/15/2001 Skin Lesion; Skin erythema - Information has been received from a physician concerning a healthy, normal 47 month old male with no immunsoppression, no concomitant medications, and no significant medical history and a possible penicillin allergy who on 22 Aug 1997 was vaccinated im with one dose of varicella virus vaccine live (lot 622978/068k) (site unknown). on 11 May 2000 the patient developed several lesions. Additionally the patient has no known recent exposure to varicella. The patient was seen by the physician and she reported 1 vesicular lesions on the helix of the right ear, and one possible vesicular lesion on his right back. The patient also had 4 or 5 other lesions which resembled mosquito bites. The patients lesions were tiny papules with surrounding erythema. The physician noted that she was not sure if the patient's lesions were chicken pox, and that some looked more pustular than vesicular. A specimen was obtained for VZV analysis, however, when the specimen arrived at the lab it was totally smashed with nothing in it. The test tube was examined to see if there was anything usable in it, however, the test tube was empty and thus discarded. On an unspecified date the patient recovered. No further information is expected. was seen by the physician and she reported 1 vesicular lesion on the helix of the right ear, and one possible vesicular lesion on his right back. The patient also had 4 or 5 other lesions which resembled mosquito bites. The patient's lesions ere tiny papules with surrounding erythema. The physician noted that she was not sure if the patient's lesions ere chicken pox, and that sore looked more pustular than vesicular. A specimen was obtained for VZV analysis, however, when the specimen arrived at the lab it was totally smashed with nothing in it. The test tube was examined to see if there was anything useable in it, however, the test tube was empty and thus discarded. On an unspecified date the patient recovered. No further information is expected. Y Y 08/22/1997 05/11/2000 993 deoxyribonucleic acid, normal range -, comment VZV specimen - not useable OTH OTH NONE Concurrent Conditions: Penicillin Allergy WAES00051222 1
0171302 06/01/2001 GA 3.0 1 .0 M 05/15/2001 Varicella - Information has been received from a company representative concerning a 43 month old male patient who on 27 Sep 1997 was vaccinated with varicella virus vaccine live. On 08 May 2000, the patient developed breakthrough chickenpox that consisted of several red lesions. It was reported that the patient was in a daycare setting. The patient sought unspecified medical attention. Additional information has been requested. Y U 09/27/1997 05/06/2000 952 OTH OTH UNK UNK WAES00051276 1
0171303 06/01/2001 NY 6.0 F 05/15/2001 Ankle Pain - Information has been received form a pharmacist concerning a 6 year old female who was vaccinated with one dose of varicella virus vaccine live. One week after vaccination, the patient experienced arthralgias in her ankles. medical attention was sought. Y U OTH OTH UNK UNK WAES00051297 1
0171304 06/01/2001 TX 7.0 7 F 05/15/2001 Rash, Blister, Fever, Skin Lesion, Pruritus, Fustule - Information has been received from a registered nurse concerning a 7 year old white female student with sulfunamide allergy who on 25 Apr 2000 was vaccinated with the first dose of varicella virus vaccine live (632612/1851j) in the right arm. On 11 May 2000 the patient developed a rash on her chest that looked like little pinpoints littel pustules, and some little vesicles. The reporter indicated that the patient had 6-8 lesions around one nipple and 10-12 lesions around the other and a slight fever of 99.6 F. The reporter also indicated that the rash was itchy, the patient sought unspecified medical attention. follow up information was received on 21 Aug 2000 from a registered nurse indicated that on 11 May 2000 the patient came into the school clinic with a rash. The nurse's concern was whether the patient was contagious to other students at school if the rash was caused by the varicella virus vaccine live. The rash appeared somewhat similiar to chickenpox and occurred aproximately three weeks after receiving varicella virus vaccine live. The patient did not appear ill and said her mom had already seen the rash. The patient came to the school clinic with the chief compaint of itching. It was noted that the patient had skin lesions, itchy rash, vesicles, pustules and a 99.6 degree oral temperature. The patient was not in distress. On an unspecified date. the patient recovered. Y Y 04/25/2000 05/11/2000 16 temperature measurement 06-11-00, value unite 99.6f, normal range -, PUB PUB UNK concurrent conditions; sulfonamide allergy WAES00051299 1
0171305 06/01/2001 LA 5.0 3 F 05/15/2001 Varicella - Information has been received from a physician concerning a 5 year old white female patient who on 31 Jul 1997 was vaccianted sc with the first dose of varicella virus vaccine live (lot 522685/0419k) in the left arm. Concomitant vaccinations included a first dose of measles (+) mumps (+) rubella virus vaccine live (MSD) lot 620805/0239E). Subsequently, the patient developed a chicken pox rash with 30-25 lesions on torso, arms, and head. The patient was afebrile and had no known exposure to wild type varicella, The patient sought unspecified medial attention. Y U 07/31/1997 05/11/2000 1015 PVT PVT UNK WAES00051318 1
0171306 06/01/2001 NJ 3.0 3 M 05/15/2001 On 04/20/2000, the patient came into the center with disseminated varicella. On an unspecified date, the patient recovered. The patient's father believes the patient could have been exposed at school where there has been an outbreak. Also reported was the patient's brother who was vaccinated and experienced similar events. Follow up information received 06/09/2000 from a NP indicated that on 04/20/2000 the patient presented to the urgent care clinic with a generalized varicella rash. The reporter clarified that the patient did not actually have a disseminated varicella infection as previously reported. The patient did not have other signs/symptoms other than a rash. The reporter was unable to provide any history on the patient, but did indicate the patient recovered completely from his experience. No further information is available. Y Y 04/17/2000 04/20/2000 3 PVT OTH UNK UNK ~Varicella (Varivax)~1~4.00~In Sibling WAES00051357 1
0171307 06/01/2001 OH U 05/15/2001 Information has been received from a health care professional concerning 6 patients, aged 3 to 7 years, who were vaccinated with varicella virus vaccine live. Subsequently, 2 patients from this lot developed breakthrough chicken pox with between 10-50 pox and a low grade fever fox less than 24 hours. The patients sought unspecified medical treatment. It was noted that all of the patients were vaccinated between 2 to 4 years of age. Additionally it was noted that 1 other patient developed a similar reaction after vaccination with varicella virus vaccine live. Additional information has been requested. Y U OTH OTH UNK UNK WAES00051408 1
0171308 06/01/2001 OH 1.0 1 .0 F 05/15/2001 On 05/01/2000, the patient developed "bumps described as a few papular lesions on trunk, some with hard centers, one with an open lesion." The patient was seen by a physician. Additional information has been requested. Y U 04/18/2000 05/01/2000 13 UNK UNK UNK UNK WAES00051418 1
0171309 06/01/2001 OH M 05/15/2001 On 05/05/2000 the patient experienced "a few spots on his face and trunk". It was noted that the patient was afebrile and has had no exposure to wild type virus. Unspecified medical attention was sought. Additional information has been requested. Y U 04/24/2000 05/05/2000 11 UNK UNK NONE NONE WAES00051421 1
0171310 06/01/2001 OH M 05/15/2001 On 05/05/2000 the patient developed an injection site rash. The patient had no known wild type exposure and was afebrile. The patient sought unspecified medical treatment. At the time of reporting the patient had not recovered. Additional information has been requested. Y N 04/26/2000 05/05/2000 9 OTH OTH UNK UNK WAES00051423 1
0171311 06/01/2001 AZ 1.2 1 .1 M 05/15/2001 On 04/27/2000 the patient experienced 3 pustular spots on the forehead and a fever. On 05/02/2000 the patient recovered. Y 03/21/2000 04/27/2000 37 PVT PVT UNK UNK WAES00051483 1
0171312 06/01/2001 CT 13.0 13 F 05/15/2001 On 03/25/2000 the patient developed an itchy rash on the right side of her neck and stomach. The rash was noted as slightly raised and fluid filled. On 04/06/2000 the patient recovered. No further information is available. Y 03/20/2000 03/25/2000 5 OTH OTH UNK UNK WAES00051497 1
0171313 06/01/2001 OH 3.0 1 .0 M 05/15/2001 On 03/22/2000, the patient developed "full blown chickenpox with no fever". Subsequently, the patient recovered. Y 11/03/1997 03/22/2000 870 PVT PVT UNK WAES00051541 1
0171314 06/01/2001 OH 1.0 1 .0 M 05/15/2001 On 04/21/2000, the patient developed "pustular lesions over the trunk of his body, a fever of up to 105F, and was not eating for 2 days. The patient was seen by a physician on 04/24/2000 and diagnosed with varicella. On 04/26/2000, the patient's fever persisted, 103F, and he was again seen by a physician. Additional information has been requested. Y U 04/19/2000 04/21/2000 2 PVT PVT Amoxil Diaper rash; erythematous rash; gastroesophageal reflux disease; otitis media; papular rash; skin lesion; WAES00051542 1
0171315 06/01/2001 PA 3.0 M 05/15/2001 Information has been received from a health care professional concerning a patient who in November 1999 was vaccinated with one dose of varicella virus vaccine live. In May 2000 the patient experienced breakthrough chickenpox. Unspecified medical attention was sought. The patient's 2 brothers had a similar experience following exposure to varicella virus vaccine live. Additional information has been requested. Y U 11/01/1999 05/01/2000 182 UNK UNK UNK UNK ~Varicella (Varivax)~~6.00~In Sibling|~Varicella (Varivax)~~4.00~In Sibling WAES00051544 1
0171316 06/01/2001 PA 4.0 M 05/15/2001 Varicella - Information has been received from a health care professional concering a 4 year old male patient who in November 1999 was vaccinated with one dose of varicella virus vaccine live. In may 2000 the patient experienced breakthrought chickenox. Unspefied medical attention was sought. The patient 's two brother waes 00051141 & 00051544 had a similar experience following exposure to varicella virus vaccine live Additional Information has been requested. Y U 11/01/1999 05/01/2000 182 UNK UNK ~Vaccine not specified (no brand name)~~3.00~In Sibling|~Vaccine not specified (no brand name)~~6.00~In Sibling WAES00051546 1
0171317 06/01/2001 NJ F 05/15/2001 Ophthalmic Trauma - Information has been received from a health care professional concerning a female physician who on 15 May 2000 was inadvertenly splashed in the eye with varicella virus vaccine live (lot 634491/0441k). Unspecified medical attention was sought. No further information is expected. Y 05/15/2000 PVT PVT UNK UNk WAES00051563 1
0171318 06/01/2001 NY 1.25 M 05/15/2001 Injection site vesticle - Information has been received from a physician concerning a 15 month old male patient with no known allergies who no known allergies who on 24 Apr 2000 was vaccinated in the right deltoid with the first dose at varicella virus vaccine live (lot 632616/16883) Concomitant vaccine that same day included the fourth dose of diphtherin toxioid (+) aceliular pertussis (+) tetanus toxoid in the left arm Lot u0163ca. Concomitant therapy also included amoxicillin for otitis media at the time of vaccination. On 04 May 2000 the patient developed fluid filled vesicles in a ring at the injection site around where the varicella virus vaccine live was given. He was afebrile and the vesicles wee non pruritic. On 13 May 2000 the patient's mother noted that she saw 2 rings of vesicles. On 15 may 2000 the patient was seen by a physician who reported seeing only one ring with the vesicles resolving and fading hyperpigmented area where the vesicles reportely were. on an unspecified date the patient recovered. Y Y 04/24/2000 05/04/2000 10 PVT PUB amoxicillia otic infections UNK WAES00051572 1
0171319 06/01/2001 KS 52.0 51 F 05/15/1991 Lack of response - Information has been received from a registered nurse concerning a 52 year old caucasian female patient who was vaccinated sc with the first and second dose of varicella virus vaccine live (lot 631171/0879J) on 01 Jun 1999 and 19 Jul 1999 respectively in the right arm. Subsequently the patients laboratory results indicated a lack of serocoversion. It was indicated that an additonal patient waes 00051818 had a similar experience. No further information is available. Y U 07/19/1999 serum varicelle zoster, normal range -, comment negative antibody titer. PVT OTH UNK UNK WAES00051581 1
0171320 06/01/2001 MA U Varicella - Information has been received from a man from the massachusetts department of public health concerning a 4 year old female with asthma who on 17 Dec 1996 was vaccinated with one dose of varicella virus vaccine live. Subsequently the patient experienced less than 50 varicella lesions on the chest, back, and nect. This was considered a mild case of varicella. On 12 May 2000 PCR analysis revealed wild type varicella virus. the patient was otherwise healthy. The patient was not an oral or inhaled steroide at the time of vaccination or within 42 days thereafter. Y U 12/17/1996 deoxyribonuecleic acid 05/12/00, normal range -, comment Pcr analysis, wild type varicella virus OTH OTH UNK concurrent conditions; asthma WAES00051664 1
0171321 06/01/2001 F 05/15/2001 skin lesion- vesiculobullous rash - Information has been received from a registered nurse concerning a female patient who on 06 May 2000 was vaccinated with a dose of varicella virus vaccine live. subsequently, the patient developed a generalized rash, about 20 lesions in number, none vesicular. There were no systemic manifestations. The patient sougth unspecified medical attention. Additional information has been requested. Y U 05/06/2000 OTH OTH UNK UNk WAES00061686 1
0171322 06/01/2001 NY 0.9 0 1 F 05/15/2001 Skin Lesion, Vesiculobullous Rash - Information has been received from aphysician concerning an 11 month old caucasian female who on 01 May 2000 was vaccinated with one dose of varicella virus vaccine live SC in the leg. on 15 May 2000 the patient experienced 20 lesions in the diaper area that were diaper rash like. She also experienced a few bumps on the upper thigh. She was afebrile. On May 20000, she experienced papuloveficular eruptions that went all the way up to her neck. The eruptions spead to the trunk. The physician thought it was chickenpox. but had not definitively diagnosed as such. The patient recovered by 25 may 2000. Medical attention was sought. No further information is available. Y Y 05/03/2000 05/15/2000 12 PVT PVT UNK UNK WAES00051694 1
0171323 06/01/2001 MO 8.0 4 U Varicella- Information has been received from a physician concerning an 8 year old white male student with no past medical history who on 08 Mar 1996 was vaccinated with the first dose of vericella virus vaccine live SC in the left thigh (lot 612212/0753B). There was no concomitant medication. On 15 May 2000 the patient experienced breakthrough chickenpox with 20 or more pox and was alightly febrile. Medical attention was sought. On 25 May 2000, the patient recovered. The patient's sister had a similar experienced following vaccination with varicella virus vaccine live (waes 00060311. Y Y 03/08/1996 05/16/2000 1530 PVT PUB NONE ~Vaccine not specified (no brand name)~1~7.00~In Sibling WAES00051748 1
0171324 06/01/2001 KS U 05/15/2001 Lack Of Response- Information has been received from a registered nurse conerning a patient who in approximately 1999 was vaccinated with a first and second dose of varicella virus vaccine live. Subsequently the patient's laboratory results indicated a lock of serocoversion. it was indicated that this occurred with an additional patient (waes 000515811 as well. Additional information has been requested. Y U 01/01/1999 test; serum variecella zoster, normal range -, comment negative antibody titer OTH OTH UNK UNK WAES00051818 1
0171325 06/01/2001 CA 5.0 F 05/15/2001 Varicella - Information has been received from a registered nurse concerning a 5 year old female who at the age of 1 was vaccinated with one dose of varicella virus vaccine live (unknown site). On 27 Apr 2000, the reported indicated that the patient has now developed varicella with approximately 100 lesions. The patient sought unspecified medical attention. Also reported was the patient brother who was vaccinated and experienced a similar event (waes 00042793).. Additional information has been requested. Y U 01/01/1996 04/27/2000 1578 OTH OTH UNK ~Vaccine not specified (no brand name)~~7.00~In Sibling WAES00051832 1
0171326 06/01/2001 OH U 05/15/2001 Varicella- Information has been received from a health care professional concerning 6 patients, aged 3 to 7 years. who were vaccinated with varicella virus vaccine live (lot 624407/1419E). Subsequently 1 patient from this lot developed breakthrough chicken pox with between 10-50 pox and a low grade fever for less than 24 hours. The patient sought unspecified medical treatment. It was noted that all of the patients were vaccinated between 2 to 4 years of age. Additionally it was noted that 2 other patients waes 00051408 developed a similar reaction after vaccination with varicella virus vaccine live . Additional information has been requested. Y U OTH OTH UNK UNk WAES00051836 1
0171327 06/01/2001 CO 4.0 1 .1 M 05/15/2001 Varicella - Information has been received from a registered nurse concerning a 4 year old male who on 25 Mar 1997 was vaccinated with one dose of varicella virus vaccine live. In May 2000 the patient experienced full blown chickenpox with greater than 100 lesions. Medical attention was sought. The patients two siblings has a similar experienced following vaccination with varicella virus vaccine live (waes 00061175 the patients twin and weas 00061176. No further information is available. Y U 03/25/1997 05/01/2000 1133 OTH OTH UNK UNK ~Vaccine not specified (no brand name)~1~4.00~In Sibling|~Vaccine not specified (no brand name)~1~6.00~In Sibling WAES00051838 1
0171328 06/01/2001 1.5 1 .5 U Varicella; otitis media - information has been received from a nurse practitioner concerning an 18 month old white female who on 04 May 2000 was vaccianted with the first dose of varicella virus vaccine live sc in the right arm lot 631779/1354J. concomitant vaccinations included measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) msd sc in the left arm lot 634232/1721J. POLIOVIRUS VACCINE ipol. alum potassium (+) diphtheria toxoid (+) pertussis vaccine (+) tetanus toxioid (tripedia) and heamophilus b conjugate vaccine acthib . On 14 may 2000 the patient developed less than 50 lesions on forehead, cheeks, trunk, and back, a low grade fever of 99.7 and cold like symptoms.. The reported indicated that the patient had no known exposure to wild type virus. The patient sought unspecified medical attention. follow up information received on 01 Aug 2000 from a physician indicated that on 14 May 2000 the patient was seen in the office for mild chickenpox (mostly on face and trunk). it was noted that at the time of vaccination the patient had an upper respiratory infection and no fever. at a later date, the patient was seen for otitis media and had cleared the lesions nicely. No further information is expected. Y 05/04/2000 05/14/2000 10 test; temperature measurement, date 05/14/00, value unit 99.7, normal range - UNK UNK upper respiratory infection NONE WAES00051957 1
0171329 06/01/2001 MI 4.0 1 .3 F 05/15/2001 Information has been received from a health care professional concerning a patient who on 05/21/1997 was vaccinated with one does of varicella virus vaccine live. On 05/14/2000 the patient developed one lesion on her face and cold-like symptoms. The patient was afebrile. Additionally it was noted that there was no exposure to wild type virus. The patient sought unspecified medical treatment. The patient was seen by a physician on 05/14/2000 with questionable chickenpox lesions on her face. One macular vesicular lesion was noted and the patient was diagnosed with mild chickenpox. Additional information has been requested. Y U 05/21/1997 05/14/2000 1089 OTH OTH UNK UNK WAES00051958 1
0171330 06/01/2001 1.0 M 05/15/2001 Information has been received from a pharmacist concerning a patient who was vaccinated with varicella virus vaccine live. The patient developed a fever on the same day of vaccination. Approximately 7 days later, the patient developed 1 raised lesion around the injection site that was peeling. Unspecified medical attention was sought. Additional information has been requested. Y U OTH OTH UNK UNK WAES00051966 1
0171331 06/01/2001 MO 24.0 M 05/15/2001 Information has been received from a medical technologist concerning a patient who on 05/02/2000 was vaccinated with one dose of varicella virus vaccine live. On 05/16/2000 the patient developed "watery blisters on his head and body and was aching". The patient sought unspecified medical attention. Additional information has been requested. Y U 05/02/2000 05/16/2000 14 OTH OTH UNK UNK WAES00051998 1
0171332 06/01/2001 IN 11.0 7 M 05/15/2001 Information has been received from a health care professional concerning a patient who on 12/31/1996 was vaccinated with a first dose of varicella virus vaccine live in the arm. On 05/15/2000 the patient developed chickenpox that consisted of about 90 lesions and a low grade fever the first few days. Subsequently, the patient sought unspecified medical attention. Follow up information from a physician's office personnel indicated that the lesions "started on 05/15/2000 and started scabbing on 05/20/2000 and were completely scabbed by 05/22/2000. The patient was seen by a physician and chickenpox was verified. Y Y 12/31/1996 05/15/2000 1231 PVT PVT UNK Streptococcal pharyngitis; ventricular septal defect; WAES00052004 1
0171333 06/01/2001 KS 1.2 1 .2 F 05/15/2001 Post vaccination, in December of 1997 the patient developed varicella. Additional patients including the patient's sister, had similar experiences following exposure to varicella virus vaccine live. Follow up information received on 08/01/2000 from the patient's mother stated that "her daughters received varicella virus vaccine live two years ago and one of her daughters broke out in a rash and the other daughter had more lesions than usual." She also reported that the "incident happened 2 years ago. Additional information has been requested. U 12/18/1997 12/31/1997 13 OTH OTH UNK ~Varicella (Varivax)~1~2.90~In Sibling WAES00052063 1
0171334 06/01/2001 KS 3.0 1 .1 M 05/15/2001 In December of 1999, the patient developed varicella. Additional information has been requested. U 10/08/1997 12/01/1999 784 PUB PUB UNK UNK WAES00052065 1
0171335 06/01/2001 KS 4.0 1 .8 M 05/15/2001 In December of 1999, the patient developed varicella and a fever. Also reported were "multiple" patients who were vaccinated and experienced similar events. No further information is available. U 12/19/1996 12/31/1999 1107 PUB PUB UNK WAES00052088 1
0171336 06/01/2001 KS 5.0 2 .7 M 05/15/2001 In December of 1999 the patient developed varicella. Additional information has been requested. U 10/16/1996 12/01/1999 1141 OTH OTH UNK UNK WAES00052067 1
0171337 06/01/2001 KS 4.0 2 .8 M 05/15/2001 In December 1999, the patient developed varicella and a fever. Additional patients had similar experiences following exposure to varicella virus vaccine live. No further information is available. U 11/06/1997 12/01/1997 25 PUB PUB UNK UNK WAES00052068 1
0171338 06/01/2001 KS 5.0 4 M 05/15/2001 In November 1999, the patient developed varicella with a high fever. Additional information has been requested. U 10/14/1999 11/01/1999 18 PUB PUB UNK UNK WAES00052069 1
0171339 06/01/2001 KS 5.0 3 M 05/15/2001 In December 1999 the patient experienced varicella with a high fever. Additional patients had a similar experience following exposure to varicella virus vaccine live. Additional information has been requested. U 03/04/1999 11/01/1999 242 OTH OTH UNK UNK WAES00052071 1
0171340 06/01/2001 3.0 3 F 05/15/2001 On 05/19/2000, post vaccination, the patient developed 3 sores, the size of a pea, on her legs and 2 on her chest. No medical attention was sought. Additional information has been requested. U 05/19/2000 05/19/2000 0 OTH OTH UNK UNK WAES00052120 1
0171341 06/01/2001 PA F 05/15/2001 Information has been received from a nurse practitioner concering a female registered nurse who in 1998 was vaccinated with a first and second dose of varicella virus vaccine live 7 months apart. This does not comply with the recommended dosage schedule. Subsequently, the patient's laboratory results indicated a low varicella virus antibody titer of 0.44. The patient sought unspecified medical attention. Additional information has been requested. Y U Serum varicella zoster - low titer OTH OTH UNK UNK WAES00052122 1
0171342 06/01/2001 TX 1.0 1 .0 M 05/15/2001 On 05/18/2000, the patient developed a "scattered papular rash that consisted of about 20-30 lesions. The red raised papules were scattered sparsely on his trunk, extremities, and face. There was no fever, pruritis, pustules, vesicles, or lesions around the injection sites. The lesions appear consistent with insect bites. There were no infected lesions. The patient sought unspecified medical attention. Follow up information from a physician indicated that no treatment was rendered and the patient recovered on 05/21/2000. Y Y 05/08/2000 05/18/2000 10 PVT PUB Griseofulvin; bactrix; Cutaneous fungal disease; otitis media; Asthma; WAES00052135 1
0171343 06/01/2001 IL 8.0 4 F 05/15/2001 On 05/19/2000 the patient developed a severe case of chicken pox from head to waist. The patient also developed a fever of 101F and had a skin infection which lasted approximately 5-7 days. The patient sought unspecified medical treatment. Additionally, it was noted that 2 other patients also developed similar reactions. Additional information has been requested. Y U 10/09/1995 05/19/2000 1684 PVT OTH UNK UNK WAES00052183 1
0171344 06/01/2001 KS 2.0 2 1 F 05/15/2001 In December 1997 the patient developed varicella. Additional patients had similar experiences following exposure to varicella virus vaccine live. U 12/18/1997 12/31/1997 13 PUB PUB UNK UNK ~Varicella (Varivax)~1~1.20~In Sibling WAES00052231 1
0171345 06/01/2001 TX 14.0 13 F 05/15/2001 On 04/21/2000 the patient developed chickenpox. The patient was treated with Zovirax. Additional information has been requested. U 01/22/1999 04/23/2000 457 PVT OTH UNK UNK WAES00052248 1
0171346 06/01/2001 VA 5.0 4 F 05/15/2001 On 05/19/2000 the patient developed a rash on her face, trunk and extremities peppered with papular vesicular eruptions in various stages. The patient was noted to be fussy and look ill. She had a fever greater than 100.1F. The patient was diagnosed with left otitis media and pharyngitis and treated wtih Suprax, Vistaril, Amoxicillin, Tylenol, and aloe vera gel. Additionally, it was noted that on 06/04/1999 the patient was vaccinated with a first dose of varicella virus vaccine live. Follow up information reported that on an unspecified date the patient recovered. Y Y 04/12/1999 05/19/2000 403 Blood granulocyte count - increased; lymphocyte count - decreased; mean platelet volume - decreased; PUB OTH NONE WAES00052273 1
0171347 06/01/2001 IL 7.0 M 05/15/2001 Information has been received from a physician concerning a patient who in approximately 1996 was vaccinated with a first dose of varicella virus vaccine live. On approximately 05/15/2000, the patient developed a "severe case of chickenpox including a high fever that resulted in being absent from school for 1 week and loss of work for his parents. The patient sought unspecified medical attention. Subsequently, the patient recovered. The patient's brother had a similar experience following exposure to varicella virus vaccine live. Y Y 05/15/2000 UNK UNK UNK UNK ~Varicella (Varivax)~~11.00~In Sibling WAES00052280 1
0171348 06/01/2001 NY 33.0 33 M 05/15/2001 Information has been received from a physician concerning a 33 year old patient who on 09/21/1999 and 10/19/1999 was vaccinated with a first and second dose, respectively of Varivax. On 05/04/2000, the patient sought unspecified medical attention and had blood tests performed which showed no immunity to varicella. In FOLLOW-UP, the physician reported that the patient received a third dose of Varivax and failed to seroconvert.The physician stated that "the antibody level was 829, far less than the 99 needed". Y U 10/19/1999 05/04/2000 198 Immunoglobulin G index - 05/04/00 failed to seroconvert after 2 doses PVT OTH UNK Diabetes mellitus WAES00052313 1
0171349 06/01/2001 MD 1.6 1 .0 M 05/15/2001 Varicella, Nasal Congestion - Information has been received from a physician concerning a 19 month old male patient who on 14 Oct 1999 was vaccinated SC with the first dose of varicella virus vaccine live in the left thigh. On 21 may 2000 the patient developed a fever of 103 degrees F. On 22 May 2000 the patient developed a rash all over with papules on his face, chest, abdomen, arms and legs. On 22 May 2000 the patient was seen by a physician and diagnosed with full blown chicken pox. The lesions were noted as starting to blister and crusted over in 6-7 days. The patient also had mild congestion and appeared ill but not toxic. The patient was trusted with diphenhydramine hcl (Benadryl) and colloidal oatmeal (aveeno). On an unspecified date the patient recovered. no further information is available. Y Y 10/14/1999 05/21/2000 220 PVT PVT UNK UNK WAES00052328 1
0171350 06/01/2001 GA 5.0 5 F 05/15/2001 Varicella - Information has been received from a licensed practical nurse. Concerning a 5 year old Caucasian female patient with a history of venticular neptal defect (closed) who on 05 Oct 1999 was vaccinated with a first dose of varicella virus vaccine live. On 16 May 2000 the patient developed chickenpox that consisted of 50-100 skin lesions. The patient sought unspecified medical attention. Follow up information from a physician's office indicated that on 26 May 2000 the patient recovered. Y Y 10/05/1999 05/16/2000 224 PVT PVT UNK medical history: venticular septal defect WAES00052330 1
0171351 06/01/2001 WA 16.0 16 M 05/15/2001 Exanthema, Pruritus- Information has been received from a physician concerning a 16 year old male who on 18 May 2000 was vaccinated sc with one dose of varicella virus vaccine live (lot 632716/1690J) (Site unknown. On 20 May 2000 the patient developed a generalized pruritic rash described as varicella like. The patient sought unspecified medical attention and the physician noted erythematomus to dull pink discrete lesions scattered along the axis of the body following the linee of cleavage in a christmas tree distrubution. They are most prominent on the trunk. There is some fine scaling in the center of many of the lesions which are oval shaped. He had some very mild comedonal acen about the temples and forehead. There are no vesicular lesions and no scabbed over vesicles. On approximately 07 Jun 2000 the patient recovered. No futher information is available. Y Y 05/18/2000 05/20/2000 2 PUB PUB UNK UNK WAES00052331 1
0171352 06/01/2001 IN 4.0 0 1 M 05/15/2001 Varicella - Information has been received from a physician concerning a 4 year old white male with a history of exposure to varicella virus in the week of 02 May 2000 who on 04 Oct 1996 was vaccinated with the first dose of varicella virus vaccine live (unknown site) on 09 May 2000 the patient developed a mild case of chicken pox with less than 30 pox. the reporter indicated that the patient was doing well and a full recovery was expected in 7-10 days. U 10/04/1996 05/09/2000 1313 OTH OTH UNK concurrent conditons: varicella exposure WAES00052385 1
0171353 06/01/2001 GA 30.0 F 05/15/2000 Lack of response - Information has been received from a registered nurse concerning a female in her 30's with an exposure to her mother who has shingles. Prior to 23 may 2000, the patient was vaccinated with one dose of varicella virus vaccine live (site unknown) number of doses unspecified. On 23 may 2000 the reporter indicated that recently the patient had a negative titer. The patient sought unspecified medical attention. Y U 01/01/2000 01/01/2000 0 serum varicella zoster, date 010100, normal range - , comment result-negative OTH OTH UNK concurrent conditions: herpes zoster exposure WAES00052400 1
0171354 06/01/2001 MA 6.0 4 M 05/15/2001 Mass - Information has been received from a health care professional concerning a 6 year old male who on 11 Feb 1999 was vaccinated with one dose of varicella virus vaccine live (site unknown) On 06 May 2000 the patient developed lesions. By 10 may 2000 the patient had approximately 63 lesions and was afebrile. The patient sought unspecified medical treatment Y U 02/11/1999 05/06/2000 450 OTH OTH UNK UNK WAES00052416 1
0171355 06/01/2001 CA U 05/15/2001 Varicella - Information has been received from a physician concerning multiple children who were vaccinated with one dose of varicella virus vaccine live. Subsequently the children developed varicella and were seen by a physician, An additional patient (waes 00031563) had a similar experience following exposure to varicella virus vaccine live Y U UNK UNK UNK UNK WAES00052480 1
0171356 06/01/2001 NJ 7.0 6 F 05/15/2001 Varicella - Information has been received from a registered nurse concerning a 7 year old caucasian female patient with an allergy to carbofed hyperactive and congestion including a stuffy nose. r otitis media, and sore throat at the time of vacccination who on 09 Dec 1998 was vaccinated with a first dose of varicella virus vaccine live (lot 628243/1340H) sc in the left arm. there were no concomitant medications. On 22 May 2000 the patient developed 6-10 lesions but no fever. The patient sought unspecified medical attention. Follow up information from a registered nurse indicated that on 22 May 2000 the patient was diagnosed with varicella. Subsequently the patient recovered. Y Y 12/09/1998 05/22/2000 530 PVT PVT NONE nasal congestion: otitis media, sore throat concurrent condition: drug allergy WAES00052598 1
0171357 06/01/2001 UT 1.75 1 .0 F 05/15/2001 Herpes Zoster- Information has been received from a physician's office concerning a 19 month old female patient who on 21 Oct 1998 was vaccianted with varicella virus vaccine live. On approximately 19 May 2000 the patient devloped shingles that consisted of a rash on the right side of the body. There was no reported fever. The patient had a recent exposure to chickenpox. The patient sought unspecified medical attention and was treated with calemine (+) camphor (+) pramoxine hydrochloride (Aveno), cetiririne dihydrochloride (zyrtec), and mupirocin (Bactroban). Additional information has been requested. Y U 10/21/1998 05/19/2000 576 OTH OTH UNK concurrent conditions; varicella exposure. WAES00052600 1
0171358 06/01/2001 ND 4.0 4 M 05/15/2001 varicella, drug reaction, rash - information has been received from a health care proessional concerning a 4 year old male with no significant medical history and no immunosuppression who on approximately 08 May 2000 was exposed to chicken pox at his daycare. On 15 May 2000 the patient present to his physician with a sore throat. culture revealed strep throat. The patient was prescribed amoxicillin for the sore throat and vaccinated with one dose of varicella virus vaccine live (lot 634477/0090K) due to his recent chicken pox exposure. On 21 May 2000 the patient developed pustules, which have progressed to a rash over his entire body. The patient was seen in the office on 24 May 2000 and diagnosed with chicken pox. The patient was noted as covered head to toe with lesions, some of which are now vesicular. In addition to the chicken pox rash, the patient developed another rash which was diagnosed as a drug reaction to the amoxicillin. the patient had a low grade fever with a maximum temperature of 102 degrees F and complained of itching as well. The patients mother treated him with colloidal oatmeal (aveno) baths and he was prescribed hydroxyzine for the itching as well. A specimen was obtained and noted to be positie for wild type vzv. It was noted that the patient recovered. No further information is available. Y Y 05/15/2000 05/21/2000 6 test: deoxyribonuclaic acid, date 05/26/00, Normal range -, comment specimen -vzv positive- wild type, test: throat culture, date 05/15/2000, normal range -, comment strep throat, OTH OTH amoxicillin streptococcal pharyngitis medical history: varicella exposure WAES00052603 1
0171359 06/01/2001 GA 2.0 1 .0 F 05/15/2001 Rash, Fever - Information has been received from a registered nurse concerning a 2 year old female patient who on 01 Apr 1999 was vaccinated with one dose of varicella virus vaccine live. These were no concomitant medications or known allergies. On 24 May 2000 the patient broke out with 30-50 pruritic lesions and experienced a fever of 101 degrees fahrenhelt. unspecified medical attention was sought. Y 04/01/1999 05/24/2000 419 OTH OTH NONE UNK WAES00052705 1
0171360 06/01/2001 M 05/15/2001 Rash - Information has been received from a consumer concerning her son who was vaccianted with one dose of varicella virus vaccine live ( site unknown). Subsequently the patient developed a rash. The patient sought unspecified medical treatment. Y U OTH OTH UNK UNK WAES00052706 1
0171362 06/01/2001 VA 1.7 1 .5 F 05/15/2001 Fever, Crying, Vomiting - Information has been received concerning an 18 month old Causcasian female who on 25 May 2000 was vaccinated with varicella virus vaccine live IM in the right, thigh. On 26 May 2000 the patient experienced fever a fever of 104.8 degrees F. crying, and vomiting. At the time of the report, the patient's vever had decreased to 100 degrees f. and the patient had recovered from the vomiting. Medical attention was sought. The patient recovered from the symptoms on 28 May 2000. Y Y 05/25/2000 05/25/2000 0 PVT PVT UNK UNK WAES00052845 1
0171363 06/01/2001 32.0 32 M 05/15/2001 Information has been received from a registered nurse concerning a 32 year old male on 5/24/00 was vaccinated with the first dose of varicella virus vaccine live SC in the left arm. On 5/25/00 the patient experienced zoster on the left side of the face. The patient experienced eight mostly vesicular lesions on the left side of the forehead. There were two separate crops of lesions. The vesicles were crusted. Medical attention was sought. Subsequently, the patient recovered from zoster on left side of face. The patient was a normal healthy adult male with no significant medical history, including no immunosuppression or known recent varicella or zoster exposure. On 6/6/00 PCR analysis revealed an inadequate specimen. No further information is available. Y Y 05/24/2000 05/25/2000 1 PCR analysis: inadequte specimen OTH OTH UNK UNK WAES00052874 1
0171364 06/01/2001 MI 3.0 F 05/15/2001 Varicella - Information has been received from a registered nurse concerning a 1 year old female patient who on 01 Nov 1999 was vaccinated with varicella virus vaccine live. On 04 May 2000, the patient presented with 4 days of vesicular rash with in creased spots over most of her body. She was diagnosed with varicella. She did not have any prodromal symptoms and at this time was not experiencing fever, but she did have moderate to severe rash, extending from head to toe. Y U 11/01/1999 05/04/2000 185 OTH OTH UNK UNK WAES00052922 1
0171365 06/01/2001 MO 1.0 8 F 05/15/2001 Varicella - Information has been received from a licensed practical nurse concerning a 12 year old caucasian female with a penicillin allergy who on 08 Mar 1996 was vaccinated with one dose of varicella virus vaccine live sc in the left thigh. On 20 May 2000 the patient experienced chickenpox. Medical attention was sought. Subsequently, the patient recovered Y Y 03/06/1996 05/20/2000 1536 PVT PUB UNK Concurrent conditions: penicillin allergy WAES00052986 1
0171366 06/01/2001 PA 2.0 1 .1 M 05/15/2001 Varicella - Information has been received concerning a 33 month old Caucasian male who on 08 Sep 1998 was vaccinated with one dose of varicella virus vaccine live. Concomitant therapy included vitamins. On 04 May 2000 the patient experienced chickenpox with at least 300 lesions. He also experienced pustules. The rash worsened. The diagnosis was made by a physician on 08 May 2000. On 09 May 2000 a VZV culture revealed no viurs, however, the physician felt it was chickenpox. Three emergency room physician visits were required. The patient was administered cetiritine dihydrochloride (Zyrtec). The patient recovered on 12 May 2000. Y Y 09/08/1998 05/04/2000 604 test: diagnostic laboratory, date 05/09/00, value unit neg, normal range -, comment vzv culture PVT PVT vitamins UNK WAES00052987 1
0171367 06/01/2001 IL 4.0 1 .3 M 05/15/2001 Herpes Zoster - Information has been received from a nurse practitioner concerning a 4 year old male with a history of usual childhood illnesses and no known history of chickenpox who on 06 Mar 1997 was vaccinated with one dose of varicella virus vaccine live 0.5 ml (lot 620620/11075) in the right arm. There was no concomitant medication. On 15 may 2000 the patient developed shingles on left flank, only painful place right on top of vesicles which was descrived as multiocculated. Vesicular lesions 4 cm X 2cm on 20 May 2000. a second lesion developed and it ws < 1/2 the size of the original. The lesions were located on the left flank just above the waist and just above that (dermatomes 8/9). The patient had a maximum temperature of 97.1 (tympanic). No other systemic symptoms were noted. A culture from the vesicle was VZV positive - wild type. The reporter stated that the patient did not have any rececent exposure to chickenpox or shingles. The patient sought unspecified medical attention and on an unspecified date recovered. No further information is available. Y Y 03/08/1997 05/15/2000 1164 test: deoxyribonucleic acid, date 05/19/00, normal range -, comment vzv positive - wild type, test temperature measurement, date 05/15/00, value unit 97.1, normal range -, comment tympanic. OTH OTH NONe UNK WAES00053009 1
0171368 06/01/2001 NY 1.0 M 05/15/2001 Rash - Information has been received from a physician concerning a 1 year old male who was vaccianted with one dose of varicella virus vaccine live. Three hours after vaccination, the patient experienced a papular rash on the legs and arms. Medical attention was sought. He was administered diphanhydramine HCL (Benadryl). Y U UNK UNK UNK UNK WAES00083032 1
0171369 06/01/2001 PA 9.0 F 05/15/2001 Mass, Rash - Information has been received from a physician concerning a normal, healthy 9 year old female with no immunosuppression and no known recent exposure to varicella who on 23 May 2000 was vaccinated in the left arm with one dose of varicell virus vaccine live (lot 634478/0091K. subsequently the patient developed lesions all over the body, mouth and genital area. The patient sought unspecified medical treatment. A physician specializing in infectious disease was consulted and noted hightly unlikely this rash was related to vaccine due to the severeity of the rash and short time frame from vaccination to onset. A specimen was obtained for DNA analysis, however, resulted indicated that the sample used for this case was an inadequate speciman. Additonally it was noted that the patients sister waes 00061037 developed a similar experienced after vaccination with varicella virus vaccine live. Follow up informaiton received from the physician indicated that the patient definitely had a history of exposure to wild type varicella prior to receiving the vaccine at least 20 other children in her school had chicken pox prior to the patients vaccination. Additonally the physician noted that the patient is doing very well and that most all of her lesions have completely dried up and healed. Additional information has been requested. Y Y N 05/23/2000 05/28/2000 5 test: deoxyribonucleic acid, normal range -, comment specimen obtained - inadequate specimen OTH OTH UNK medical history: varicella exposure WAES00053062 1
0171414 06/01/2001 NJ F 05/15/2001 Mass; Bone Pain, headache, pruritus, rash, musculoskeletal pain, warm sensation - Information has been received from female consumer who is a registered nurse who on 31 May 2000 reports recent exposure to several adults with shingles and several children with chicken pox. On 09 Jun 1999 the patient was vaccianted with one dose of varicella virus vaccine live (site unknown). On 30 May 2000, the patient experienced a terrible headache and bone/spine pain. On 31 May 2000 the patient reported that she developed 3-6 lesions on her back and she stated that it feels like her back is on fire and is very itchy. She reported that she also has a rash on her upper truck under her breast which is new. She stated that this was very unsual for her and she is going to call a pysician to schedule an appointment. The patient sought unspecified medical attention. Additional information has been requested. Y U 06/08/1999 05/30/2000 357 OTH OTH UNK concurrent conditions: herpes zoster exposure; varicella exposure WAES00060036 1
0171415 06/01/2001 MI 1.0 1 .0 M 05/15/2001 Varicella- Information has been received from a nurse practitioner concerning a 5 year old white male with seasonal allergies and an allergy to milk and red dye. On 11 Mar 1996 the patient was vaccinated with the second dose of varicella virus vaccine live (lot 612225/11308) in the left leg. Concomitant therapy included the second dose of measles virus vaccine live (+) mumpus virus vaccine live (+) rubella virus vaccine live (second generation) (msd) lot 614259/1424b in the right leg and loratadine (claritin). On 27 May 2000 the patient developed 20-30 itchy, lesions but was afebrile. The patient sought unspecified medial attention. Follow up information received on 31 Jul 2000 from a physician indicated that it was on 31 May 2000 that the patient developed 30 or less varicella lesions, a mild illness. On an unspecified date the patient recovered. it was also noted that on 12 Jun 2000 the patient's sibling developed varicella. No further information is expected. Y Y 03/11/1996 05/31/2000 1542 PVT PVT claritin concurrent conditions; dye allergy, food allergy, seasonal allergy WAES00060056 1
0171416 06/01/2001 NC 29.0 28 M 05/15/2001 Exanthema - Information has been received from a registered nurse concerning a 28 year old caucasian male diabetic patient who on 16 May was vaccinated sc in the left arm with a first dose of varicella virus vaccine live (lot 634839/10643J). On 02 Jun 2000 the patient developed 10-12 lesions that looked like varicella. The patient was seen by a physician and on an unspecified date recovered. It was noted that on 15 Jun 2000 the patient was vaccinated in the left arm with a second dose of varicella virus vaccine live (lot 634839/1874J) Y Y 05/16/2000 06/02/2000 17 UNK UNK UNK Concurrent Conditions; diabetes Mellitus WAES00060092 1
0171417 06/01/2001 WA 1.0 F 05/15/2001 Varicella- information has been received from a registured nursed concering a 12 month old female who is a twin. In may 2000 the patient was vaccinated with one dose of varicella virus vaccine live (site unknown) Ten days post vaccination, the patient devloped 10-15 or 50 vesicles and the next day had a full blown case of chickenpox and was broken out all over with hundreds of chickenpox indicating that the patient had already been unkowingly exposed by an active source. Unspeicified medical attention was sought. also reported was the patient's twin sister who was vaccinated and developed similar events (waes 00060277). Y U 05/01/2000 05/01/2000 0 OTH OTH UNk Medical History - twin birth, concurrent conditions - varicella exposure ~Vaccine not specified (no brand name)~1~1.00~In Sibling WAES00060099 1
0171418 06/01/2001 CA 2.0 0 1 F 05/15/2001 Impetigo, Fever - Information has been received from a physician's office concerning a 2 year old Spanish female patient with wild type varicella exposure who on 29 Jan 1999 was vaccianted with a first dose of varicella virus vaccine live in the left thigh. On 24 May 2000, the patient developed a really bady case with infected lesions, a couple on her face about 3 cm around her mouth, nostrils, ears, and all over her body. she had a fever last week, but on 31 May 2000 at the office visit, she did not. The patient was treated with topical antibiotics. Follow up information from a physician's office indicated that on 31 May 2000, the patient presented with large lesions on her right earlobe and around her mouth and nostrils. The lesions wore 3 cm and became infectious. The patient was diagnosed with impetigo and treated with amoxicillin triphydrate (+) clavalanate potassium (Augmentin) 400 mg and mupirocin (Bactroban) ointment. On 07 Jun 2000 the patient recovered. Y Y 01/29/1999 05/24/2000 481 UNK UNK UNK Concurrent Conditions: Varicella exposure WAES00060217 1
0171419 06/01/2001 GA 5.0 0 .5 F 05/15/2001 Varicella- Information has been received from a registered nurse concerning a 5 year old female patient who in 1995 was vaccinated with varicella virus vaccine live. On 01 Jun 2000 the physician's office was notified by the patient's mother that she has developed approximately 20 varicella lesions. Unspecified medical attention was sought. Additional information has been requested. Y U 01/01/1995 06/01/2000 1978 OTH OTH UNK UNK WAES00060239 1
0171420 06/01/2001 NJ 31.0 M 05/15/2001 Dysuria- Information has been received from a physician concerning a 31 year old male who was vaccinated with one dose of varicella virus vaccine live (Site unknown). Subsequently the patient experienced dysuria. The reporting physican felt that dysuria was not related to varicella virus vaccine live. medical attention was sought. No further information is available. Y U OTH OTH UNK UNk WAES00060242 1
0171421 06/01/2001 IN 4.0 3 M 05/15/2001 Skin Lesion - Information has been received from a registered nurse concerning a 4 year old caucasian male patient with no allergies or medical history who on 19 Aug 1998 was vaccinated with a first dose of varicella virus vaccine live in the left arm. On 07 May 2000 the patient developed round, fluid filled skin lesions erupting successively over a 3 day period from 07 May 2000 to 11 May 2000. Most lesions had healed or disappeared by 14 May 2000. The patient was treated with calamine (+) pramoxine (+) nine acetate (Caladryl) and one or two doors of diphendydramine HCL (Benadryl) was given for itching. on 14 may 2000, the patient recovered. Y 08/19/1998 05/07/2000 627 PVT PVT UNK NONE WAES00060253 1
0171422 06/01/2001 WA U Varicella - Information has been received from a registered nurse concerning a 12 month old female who is a twin. In may 2000 the patient was vaccinated with one dose of varicella virus vaccine live (site unknown). Ten days post vaccination, the patient developed 10-15 or 50 vesicles and the next day had a full blown case of chickenpox and was broken out all over with hundreds of chickenpox indicating that the patient had already been unknowingly exposed by an active source. Unsepecified medial attention was sought. Also reported was the patient's twin sister who was vaccinated and developed similar events (Waes 00060099). Y U 05/01/2000 05/01/2000 0 OTH OTH unk Medical History : twin birth, Concurrent conditions: vaicella exposure ~Vaccine not specified (no brand name)~1~1.00~In Sibling WAES00060277 1
0171423 06/01/2001 GA 5.0 3 M 05/15/2001 Varicella - Information has been received from a physician concering a 5 year old male patient who on 14 May 1998 was vaccianted in the right lateral thigh with a first dose of varicella virus vaccine live (lot 625379/0308H). There were no illnesses at the time of vacciantion. On 02 Apr 2000 the patient developed chickenpox and was soon in the physican's office on 03 Apr 2000. Y U 05/14/1998 04/02/2000 689 NONE UNK UNK UNK UNK WAES00060289 1
0171424 06/01/2001 PA 1.3 1 .3 M 05/15/2001 Fever, Rash - Information has been received from a physician concerning a 14 month old caucasian male patient who on 16 May 2000 was vaccinated Im in the left arm with a first dose of varicella virus vaccine live (lot 632056/1449J) There were no concomitant medications, past medial history or known allergies. On 29 may 2000 the patient woke up with a fever. It was noted that his fever was 102 fahrenhit during the day and went up to 104 fahrenbelt at night. On 01 Jun 2000 the patient developed a few dots on his body and as of 02 Jan 2000 the patient had approxiamtely 40-50 dots all over his body and remained febrile. Follow up information received from a physician reported that the fever lasted for three days. The patient was seen in the physician's office and the rash that the patient developed was noted to be a probable roseola virus infection. The patient recovered on an unspeicified date. no further information is available. Y Y 05/16/2000 05/29/2000 13 NONE PVT OTH NONE NONE WAES00060314 1
0171425 06/01/2001 FL 22.0 22 M 05/15/2001 Varicella, Injection site erythmea- Information has been received from a registered nurse concerning a 22 year old male patient who on 17 May 2000 was vaccinated sc with one dose of varicella virus vaccine live . On 28 May 2000 the patient developed a fever and one lesion with a clear center at the injection site. Unspecified medical attention was sought. it was noted that as of 02 Jun 2000 a grapefruit size redness had developed around the lesion at the injection site. additionally, more pox have developed it was reported that the patient's antibody was negative prior to vaccination. Y U 05/17/2000 05/28/2000 11 test: serum varicella zoster, normal range -, comment negative prior to vaccination OTH OTH UNK UNK WAES000060316 1
0171426 06/01/2001 NY 9.0 7 F 05/15/2001 In June, 1999 the patient experienced a vaccine related rash. It was noted that the patient had what appeared to be a mild case of chickenpox with about 20-30 lesions which cleared in 3 days. In February, 2000 the patient developed a similar rash as before. The patient was seen by a physician who stated "looks like mild chicken pox-must be a virus". This was noted to be milder than the first case. On May, 2000 the patient developed the "same chicken pox appearing rash with > 30 lesions". It was also indicated that the lesions were pustular. The patient was afebrile and experienced some respiratory symptoms. It was noted that the patient had sat next to a girl 2 weeks previous who came down with chickenpox the next day. It was noted that the patient did not have scoliosis. On an unspecified date, the patient recovered. No further information is expected. Y Y 07/15/1997 06/01/1999 686 audiogram - wnl; blood pressure - 116/58; visual acuity test - 20/20; PVT PVT NONE Adhesive tape allergy; varicella exposure; WAES00060321 1
0171427 06/01/2001 MI 6.0 1 .6 M 05/15/2001 On 06/01/2000 the patient developed a fever of 101.2F and on 06/02/2000 was diagnosed with 40-50 varicella lesions and a fever of 101.8. The pox were 1/2 cm in size with erythema surrounding. Y U 06/07/1995 06/01/2000 1821 OTH OTH UNK UNK WAES00060323 1
0171428 06/01/2001 IL 1.6 1 .7 M 05/15/2001 On 05/26/2000 the patient developed local and generalized lymphadenopathy. The patient was seen in the physician's office. At the time of the office visit, the physician noted a large axillary lymph node. According to the patient's parents, the lymphadenopathy had persisted for at least 5 days. Follow up information from a physician reported that the patient's symptoms improved over time and that on an unspecified date the patient recovered. Y Y 05/23/2000 05/26/2000 3 PVT OTH Hydrocortisone Ointment eczema Allergy; asthma; eczema; eggs allergy; WAES00060324 1
0171429 06/01/2001 4.0 M 05/15/2001 On 06/02/2000, the patient did not have an appetite and had a fever. The patient sought unspecified medical attention. Additional information has been requested. Y U 06/01/2000 06/02/2000 1 OTH OTH UNK WAES00060351 1
0171430 06/01/2001 MN 24.0 24 F 05/15/2001 Information has been received from a health care professional concerning a patient who on 03/28/2000 was vaccinated with one dose of varicella virus vaccine live. Subsequently, the patient missed 2 menstrual periods, however, a pregnancy has not yet been confirmed. Additional information has been requested. Follow up was received which indicated that after 2 months of amenorrhea, the first pregnancy test had been negative but they would repeat it in another month to confirm it. Since enough time had passed from LMP with the initial test, the reporter assumed another etiology for the amenorrhea and did not believe the patient was pregnant. This report is part of the pregnancy registry. Y U 03/28/2000 beta-human chorionic - negative; OTH OTH UNK Pregnancy (LMP = Unknown) WAES00060383 1
0171431 06/01/2001 IN 8.0 4 M 05/15/2001 On 05/28/2000 the patient presented to a physician with chickenpox consisting of approximately 50 to 100 lesions. Additional information has been requested. Y U 10/21/1996 05/28/2000 1315 PVT OTH UNK UNK WAES00060413 1
0171432 06/01/2001 GA 3.0 1 .1 M 05/15/2001 On 04/13/2000, the patient developed a mild breakthrough rash described as fluid filled itchy eruptions > 12. On 04/26/2000, the patient recovered. Additional information has been requested. Y 07/30/1997 04/13/2000 988 PVT OTH UNK Penile disorder WAES00060451 1
0171433 06/01/2001 OH 3.0 0 1 F 05/15/2001 On 06/03/2000 the patient developed red bumps in her groin that were non-pruritic. It was noted that the patient was afebrile. On 06/05/2000 she sought unspecified medical attention and was diagnosed with chickenpox. Follow up information reported that the patient developed 4 crusted erythematous lesions in the groin and erythematous papules on her stomach. It was noted that the rash was "non-ill appearing". No further information is expected. Y U 11/12/1997 05/03/2000 903 Tuberculin skin test - results unknown PVT OTH UNK NONE WAES00060502 1
0171434 06/01/2001 IL 7.0 2 .2 M 05/15/2001 In April, 2000 the patient developed chicken pox. The patient sought unspecified medical treatment. Additionally it was noted that two other patients also developed similar reactions. Additional information has been requested. Y U 08/03/1995 OTH OTH UNK UNK WAES00080542 1
0171435 06/01/2001 IL 5.0 M 05/15/2001 Information has been received from a physician concerning a patient who in 1996 was vaccinated with one dose of varicella virus vaccine live. In approximately May, 2000 the patient developed a mild case of chicken pox. The patient sought unspecified medical treatment. Additionally it was noted that 2 other patients also developed similar reactions. Additional information has been requested. Y U 05/01/2000 OTH OTH UNK UNK WAES00060543 1
0171436 06/01/2001 MA 2.0 1 .4 F 05/15/2001 Information has been received from a physician concerning a patient who in March, 1999 was vaccinated SC with one does of varicella virus vaccine live. On 06/06/2000 the patient developed a localized patch under her left axilla which the reporting physician "thinks may be herpes zoster". The area was noted to be painful and causing the patient discomfort. Additional information has been requested. Y U 03/01/1999 06/06/2000 463 OTH OTH UNK UNK WAES00060819 1
0171437 06/01/2001 TX 38.0 F 05/15/2001 Information has been received from a health care professional concerning a patient who is pregnant who in 1995 was vaccinated with the first and second doses of varicella virus vaccine live. Subsequently, the patient had lab work which revealed that she had not seroconverted. Unspecified medical attention was sought. Additional information has been requested. Y U negative varivax antibody titer UNK UNK UNK WAES00060579 1
0171438 06/01/2001 CO 1.08 1 .0 M 05/15/2001 On 06/05/2000 the patient started to develop a diffuse papular-pustular rash. On 06/06/2000, the patient was seen by a physician and diagnosed with chickenpox that consisted of "many lesions on his back, arms and chest with no fever. Follow up information from a physician's office indicated that no action was taken and the patient subsequently recovered. Y Y 06/02/2000 06/05/2000 3 PVT PVT UNK UNK WAES00060719 1
0171439 06/01/2001 1.2 1 .2 F 05/15/2001 A few hours post vaccination, the patient developed a rash all over her body and a fever of 100.7F. Unspecified medical attention was sought. Additional information has been requested. Y U 03/28/2000 03/28/2000 0 OTH OTH NONE UNK WAES00050720 1
0171440 06/01/2001 1.0 M 05/15/2001 One to 2 days post vaccination, the patient developed a rash on his stomach. No further information is available. U OTH OTH UNK UNK WAES00060724 1
0171441 06/01/2001 MN U 05/15/2001 Information has been received from a health care professional concerning a patient who approximately "1 to 2 years ago" was vaccinated with one dose of varicella virus vaccine live. On 04/20/2000 the patient developed a mild breakthrough of chickenpox with approximately 75 pox and no fever. The patient sought unspecified medical attention. Also reported was the patient's sister, one other sibling, and several other patients who were vaccinated and experienced similar events. Additional information was requested. Y U 04/20/2000 OTH OTH UNK UNK ~Varicella (Varivax)~~0.00~In Sibling|~Varicella (Varivax)~1~5.00~In Sibling WAES00080776 1
0171442 06/01/2001 MN U 05/15/2001 Information has been received from a health care professional concerning a patient who approximately "1 to 2 years ago" was vaccinated with 1 does of varicella virus vaccine live. On 04/20/2000 the patient developed breakthrough chickenpox with approximately 75 pox and no fever. The patient sought medical attention. Also reported was the patient's sister, one other sibling, and several other patients who were vaccinated and experienced similar events. Additional information has been requested. Y U 04/20/2000 OTH OTH UNK UNK ~Varicella (Varivax)~1~5.00~In Sibling|~Varicella (Varivax)~~0.00~In Sibling WAES00060777 1
0171443 06/01/2001 MA F 05/15/2001 Information has been received from a physician concerning a female who was vaccinated with one dose of varicella virus vaccine live. Subsequently the patient failed to seroconvert. Unspecified medical attention was sought. Additional information has been requested. Y U Negative varicella antibody titer OTH OTH UNK UNK WAES00080820 1
0171444 06/01/2001 MA 1.01 1 .0 M 05/15/2001 On 04/03/2000 the patient was seen by the physician for a headache and 2 papules on his right arm. On 04/04/2000 the patient was again examined by the physician and was seen in the ER on 04/05/2000 for a persistent headache and unsteady gait. It was reported that the was "stumbling" and "falling" and was "definitely ataxic". The patient's mother reported that for the last 3 weeks, the patient has had right arm tremors "when eating or excited" that extinguish when she holds his arm from a moment. Physical examination revealed a patient who has ataxia and is positive for right arm tremor. On 04/08/2000 the patient presented to the physician with a right ear infection. On 04/12/2000 it was noted that the patient was "still wobbly, but improving". On 04/18/2000 the patient still had right otitis media. It was noted that presecription drug therapy was not required for this partner. Follow up information received from a physician reported that on 04/18/2000 the patient recovered from his experience. Y Y 03/27/2000 04/03/2000 7 CSF differential white - 1; serum alkaline - high; mean platelet volume - low; mean corpuscular volume - low; csf red blood cell - increased PVT PUB Otitis media WAES00060913 1
0171445 06/01/2001 NJ 4.0 4 M 05/15/2001 On 06/08/2000 the patient developed approximately 20 itchy chicken pox lesions. The patient was afebrile. Unspecified medical attention was sought. Follow up information from the RN indicated the final record was that the patient did not have chicken pox and that they were actually insect bites. Further information from the NP confirmed that the patient was unable to walk or talk (pre-existing condition). She had no report of the patient being vaccinated with MMRII on 05/02/2000. They only had a record of the patient being administered the Mantoux test on 05/02/2000. On 05/04/2000 a negative test result was obtained. Follow up information was received from an individual at the health center who confirmed that on 05/02/2000 the patient was administered a dose of measles-mumps-rubella vaccine. No further information is available. Y U 05/02/2000 06/08/2000 37 Tuberculin skin test - negative UNK UNK Cerebral palsy WAES00060962 1
0171446 06/01/2001 MN 5.0 1 .5 F 05/15/2001 On approximately 04/03/2000, the patient developed a fever that ranged at 101 and experienced a stomachache. On 04/07/2000, the patient developed 100 varicella lesions and was noted to be "pretty well covered in pox's". The patient sought unspecified medical attention and on 04/15/2000-04/16/2000 the patient recovered. It was also noted that the patient's two siblings and "several" other patients were vaccinated and experienced similar events. Y Y 10/05/1995 04/01/2000 1640 PVT PVT UNK Application site reaction; drug allergy ~Varicella (Varivax)~~0.00~In Sibling|~Varicella (Varivax)~~0.00~In Sibling WAES00061033 1
0171447 06/01/2001 6.0 6 F 05/15/2001 Information has been received concerning a pt who has a history of varicella exposure, was vaccinated on 05/30/00 with one dose of varicella vaccine. On 06/08/00 the pt developed generalized vesicular lesions. Additionally, it was noted that the pt's sister experienced a similar reaction. On 06/09/00 two swab specimens were obtained for VZV identification, however the specimens were inadequate to process. Y U 05/30/2000 06/08/2000 9 daoxyriboncleic acid on 06/09/00 swab specimen was inadequate to process OTH OTH UNK varicella exposure ~Varicella (Varivax)~~9.00~Sibling|~Varicella (Varivax)~~9.00~Sibling WAES00061037 1
0171448 06/01/2001 WA 1.25 1 .3 M 05/15/2001 Immediately upon administering the vaccine, the patient's arm turned quite red. Within seconds, a small one inch wheal/hive developed at the site of injection. There was no respiratory involvement or systemic reactions. The patient was observed for 20 minutes. The reaction appeared to be resolving spontaneously. Follow up information from a RN indicated that the injection site wheal "resolved spontaneously". It was noted that 5 weeks post-onset, the patient had a similar reaction to MMR. Y 06/02/2000 06/02/2000 0 PVT PUB Allergy, asthma, eggs allergy, wheat allergyw injection site erythema~Measles + Mumps + Rubella (MMR II)~~1.25~In Patient WAES00061052 1
0171449 06/01/2001 4.0 1 .5 M 05/15/2001 On 06/04/2000, post-vax, the patient broke out in a varicella-like rash. Unspecified medical attention was sought. The physician noted that the patient's rash had not yet started to "scab over" after 5 days. The patient's sibling had a similar experience following exposure to varicella virus vaccine live. Follow up information from a physician reported that the patient developed chickenpox and that the course of the disease was 7-10 days. It was noted that the papules never crusted but faded. The physician reported that the "patient was considered contagious until the rash was completely gone which was a guess at best". The patient is recovered. Y Y 08/01/1997 06/04/2000 1038 OTH OTH UNK NONE ~Varicella (Varivax)~~1.25~In Sibling WAES00061110 1
0171450 06/01/2001 OR 1.0 0 .9 M 06/15/2001 Information has been rec'd from a RN concerning a pt with no past medical history or known allergies who on 6/1/00 was vaccinated SC in the R arm with a 1st dose of varicella virus vaccine live (lot#46376051849J). On 6/9/00 the pt developed red, raised bumps at the injection site. Unspecified medical attention was sought. It was noted that the pt was afebrile and that the injection site reaction was approximately the size of a nickel. No further information is available. Y U 06/01/2000 06/08/2001 372 PVT PVT NONE NONE NONE WAES00061124 1
0171451 06/01/2001 CO 4.0 1 .1 M 05/15/2001 Information has been received from a registered nurse concerning a pt who on 3/25/97 was vaccinated with 1 dose of varicella virus vaccine lie. In May 2000, the pt experienced full-blown chickenpox with greater than 100 lesions. Medical attention was sought. The pt's 2 siblings had a similar experience following vaccination with varicella virus vaccine live (WAES00051888)(the other pt's twin) and (WAES00061176). No further information is available. Y U 03/25/1997 05/01/2000 1133 OTH OTH UNK UNK ~Varicella (Varivax)~1~4.00~In Sibling|~Varicella (Varivax)~1~6.00~In Sibling WAES00061175 1
0171452 06/01/2001 CO 3.0 2 1 M 05/15/2001 Information has been rec'd from RN concerning a pt who on 4/25/97 was vaccinated sc in the arm with a 1st dose of varicella virus vaccine live (lot#620615/1340D). There were no illnesses at the time of vaccination. In May 2000 the pt experienced full blown chickenpox with greater than 100 lesions. The pt was seen in the physician's office. His 2 siblings had a similar experience following vaccination with varicella virus vaccine lie (WAES 00051888 and 00061175). Additional information has been requested. Y U 04/25/1997 06/01/2000 1133 PVT PVT UNK UNK ~Varicella (Varivax)~1~4.00~In Sibling|~Varicella (Varivax)~1~4.00~In Sibling WAES00061176 1
0171453 06/01/2001 GA U 05/15/2001 Information has been rec'd from a hlth professional concerning a child who in August 1998 was vaccinated with one dose of varicella virus vaccine live. Subsequently the pt experienced chickenpox. Medical attention was sought. 3 other pt's had a similar experience following vaccination with varicella virus vaccine live (WAES00042794 and 00061292-0001183). No further information is available. Y U 08/01/1998 UNK UNK UNK UNK WAES00061181 1
0171454 06/01/2001 GA U 06/15/2001 Information has been received from a healthcare professional concerning a patient who in 1999 was vaccinated with one dose of varicella virus vaccine live. Subsequently, the patient experienced chickenpox. Medical attention was sought. Three other patients had a similar experience following vaccination with varicella virus vaccine live. No further information is available. Y Y UNK UNK UNK UNK WAES00061182 1
0171455 06/01/2001 GA U 05/15/2001 Information has been received from a healthcare professional concerning a patient who in 1997 was vaccinated with one dose of varicella virus vaccine live. Subsequently, the patient experienced chickenpox. Medical attention was sought. Three other patients had a similar experience following vaccination with varicella virus vaccine live. No further information is available. Y U UNK UNK UNK UNK WAES00061183 1
0171456 06/01/2001 GA 7.0 F 05/15/2001 The patient was vaccinated in 1996 with a first dose of varicella virus vaccine live. Subsequently, the patient experienced mild chickenpox. On an unspecified date the patient recovered. Two other patients had similar experiences following exposure to varicella virus vaccine live. Y NONE UNK UNK UNK NONE WAES00061188 1
0171457 06/01/2001 GA 6.0 4 F 05/15/2001 In August of 1998 the patient was vaccinated with a first dose of varicella virus vaccine live. Subsequently, the patient experienced "mild chickenpox". Two other patients had similar experienced following exposure to varicella virus vaccine live. U 06/01/1998 NONE PUB PVT UNK NONE WAES00061187 1
0171458 06/01/2001 OH 4.0 0 .9 M 05/15/2001 On 06/10/2000, the patient developed breakthrough chickenpox that consisted of approximately 30 lesions and a low grade fever. The patient sought unspecified medical attention. A nurse indicated that she had been noticing a lot of chickenpox in the area, although exposure of the patient to varicella was unknown. No further information is available. Y U 07/16/1996 06/10/2000 1425 PVT PVT NONE NONE WAES00061227 1
0171459 06/01/2001 IA 1.25 1 .2 M 05/15/2001 On 06/11/2000 the patient developed chicken pox. The patient sought unspecified medical treatment. Addtional information has been requested. Y U 06/02/2000 08/11/2000 70 OTH OTH UNK UNK WAES00061264 1
0171460 06/01/2001 NY U 05/15/2001 Information has been received from a RN concerning a patient was in May of 2000 was vaccinated with one dose of varicella virus vaccine live. In approximately June 2000, the patient developed chickenpox. Unspecified medical attention was sought. Additional information has been requested. Y U 05/01/2000 06/01/2000 31 OTH OTH UNK UNK WAES00061281 1
0171461 06/01/2001 M 05/15/2001 Information has been received form a consumer concerning his son who in approximately April 2000 was vaccinated with one dose of varicella virus vaccine live. Subsequently the patient experienced a "mild case" of chickenpox. The patient's brother had a similar experience following exposure to varicella virus vaccine live. Additional information has been requested. U OTH OTH UNK UNK ~Varicella (Varivax)~~0.00~In Sibling WAES00081332 1
0171462 06/01/2001 TX 1.25 1 .0 M 05/15/2001 The patient was vaccinated in March 2000. On 06/04/2000 the patient broke out in a chicken pox rash. He had the rash for 14 days and it did not crust. He also developed URI symptoms with wheezes. It was reported the rash began to crust 14 days after the appearance of the 1st lesion. It was noted that the patient saw a physician 2 times. the patient's sibling had a similar experience following exposure to varicella virus vaccine live. Additional information has been requested. Y U 03/01/2000 06/04/2000 95 UNK UNK UNK NONE ~Varicella (Varivax)~~4.00~In Sibling WAES00061336 1
0171463 06/01/2001 MI 1.0 1 .0 F 05/15/2001 Information has been received concerning a pt who was vaccinated and approximately 2 weeks later the pt developed 13 fluid filled vesicles located on her back, left thigh, and face. Unspecified medical attention was sought. It was noted the vesicles crusted over and on an unspecified date the pt recovered. Y Y 05/12/2000 05/24/2000 12 PVT PVT UNK WAES00061355 1
0171464 06/01/2001 IL 11.0 M 05/15/2001 Information has been received concerning a pt who post vaccination of varicella developed a severe case of chicken pox and high fever that resulted in being absent from school for 1 week and loss of work for his parents. The pt sought unspecified medical attention. The pt recovered. Y Y UNK UNK UNK UNK ~Varicella (Varivax)~1~7.00~In Sibling WAES00061359 1
0171465 06/01/2001 VA F 05/15/2001 Information has been received concerning a female pt who was vaccinated with 2 doses of varicella. Subsequently the pt failed to seroconvert. it was reported that the pt is pregnant now. No additional doses were given. Unspecified medical attention was sought. Y U diagnostic laboratory-negative varicella antibody titer OTH OTH UNK Pregnancy LMP unknown WAES00061418 1
0171466 06/01/2001 CA 30.0 26 F 05/15/2001 Information has been received concerning a pt who on 05/24/96 was vaccinated with her first dose of varicella vaccine. The pt received the second dose of varicella on 07/18/96. It was noted that the pt was exposed to varicella and that there were no illnesses at the time of vaccination. On 06/13/2000 the pt experienced a fever of 101 F. She had muscle aches and approximately 15 pox. Unspecified medical attention was sought and the pt was diagnosed with varicella. Treatment included Tylenol as needed and rest. It was reported the pt recovered. Y Y 07/18/1996 06/13/2000 1426 OTH OTH UNK varicella exposure WAES00061431 1
0171467 06/01/2001 MI 7.0 3 F 05/15/2001 Information has been received concerning a pt who had been vaccinated with varicella vaccine and 2 years the pt developed chickenpox that consisted of approximately 10 lesions and no fever. It was not known if the pt was exposed to wild type varicella virus. It was reported that the pt sought unspecified medical attention. Follow up information from the mother indicated that her daughter broke out into a fluid filled rash all over her body. The pt was never seen in physician's office but the pt did recover. Y 01/09/1996 06/13/2000 1617 PVT PVT UNK WAES00061442 1
0171468 06/01/2001 NC 27.0 24 F 05/15/2001 Information has been received concerning a pt who was vaccinated on 05/30/97 and 06/30/97 with first and second doses of varicella virus vaccine. there were no illnesses at the time of vaccination. On 05/09/2000 the pt experienced a full blown case of chickenpox. It was noted that she was covered with pustules. Additionally, the pt believed that she was exposed to varicella through her infant son who had not been vaccinated and recently had wild type varicella. The pt recovered on 05/19/00. Y 06/30/1997 05/08/2000 1043 PUB PVT UNK Varicella exposure WAES00061471 1
0171469 06/01/2001 M 06/15/2001 Information has been received from a consumer concerning his son who in approximately 04/00 was vaccinated with one dose of varicella vaccine. Subsequently, the pt experienced a severe case of chickenpox, It was noted that the pt was home from school for a week. U 04/01/2000 OTH OTH UNK UNK ~Varicella (Varivax)~~0.00~In Sibling WAES00061633 1
0171470 06/01/2001 PA 31.0 30 F 06/15/2001 Information has been received concerning a pt who was vaccinated on 06/16/99 and 07/20/99 with her 1st and 2nd dose of varicella virus vaccine. Subsequently, lab work revealed that the patient had no detectable antibodies. Unspecified medical attention was sought Y U 07/20/1999 06/15/2000 331 diagnostic laboratory on 06/15/00 results negative varicella antibody titer PVT PVT Zoloft UNK WAES00061751 1
0171471 06/01/2001 IL F 05/15/2001 Information has been received concerning a pt who was vaccinated with 2 doses of varicella vaccine. Subsequently, the pt sought unspecified medical attention and was tested for antibodies. The results were negative. A third dose of varicella vaccine was administered and the pt was re-tested and found to have a negative antibody titer. Y U serum varicella zoster negative antibodies after 2 doses, still negative after 3rd dose OTH OTH UNK UNK WAES00061780 1
0171472 06/01/2001 NJ 4.0 4 F 05/15/2001 Information has been received concerning a pt who was vaccinated on 06/10/00 with her first dose of varicella vaccine. On the 06/16/00 she was seen in the physician's office and diagnosed with a chickenpox rash. The pt was seen again on 06/26/00 and it was noted that the rash had dried up. Y Y 06/10/2000 06/15/2000 5 PVT OTH NONE UNK WAES00061888 1
0171473 06/01/2001 14.0 F 05/15/2001 Information has been received concerning a pt who in 1990 and approximately 1995 or 1996 was vaccinated with the first and second dose of varicella vaccine. The pt developed full blown chickenpox all over her body, roof of her mouth, the whole nine yards. However, the reporter noted that she needs to identify the varicella, it may be hives. N OTH OTH UNK UNK WAES00061996 1
0171474 06/01/2001 PA 14.0 7 F 05/15/2001 Information has been received from a consumer concerning her 14 year old daughter who was vaccinated with a first and second dose of varicella on 01/06/1988 and 02/19/1993. On 06/17/2000, the pt developed chickenpox that consisted of approximately 40 lesions on her face. The lower part of her body had very few skin lesions. U 02/19/1993 06/17/2000 2675 OTH OTH NONE NONE WAES00062046 1
0171475 06/01/2001 MN 3.0 4 F 05/15/2001 Information has been received about a pt that experienced redness, swelling, and itchiness 10 days post vaccination. 11 days post vaccination the pt developed an injection site blister. She was itchy from 6/6/00 to 6/21/00. On 06/20/00 the pt experienced red spots on the right arm, abdomen, and back. The total number of spots was ten. Medical attention was sought and the pt was treated with Benadryl and recovered by 7/1/00. Y Y 06/06/2000 06/16/2000 10 PUB PUB UNK UNK WAES00062048 1
0171476 06/01/2001 NY 8.0 4 M 05/15/2001 Information has been received concerning a pt who was vaccinated with varicella vaccine on 10/26/95. In June of 2000, the pt was diagnosed by his mother with mild breakthrough varicella. the pt sought unspecified medical attention. It was reported that the pt had a normal incubation period and recovered shortly afterwards. Y Y 10/26/1995 06/01/2000 1680 PVT PVT Singulair arrhythmia, asthma, herniorrhaphy, keratosis pilaris, orchiopexy WAES00052084 1
0171477 06/01/2001 MA 1.25 1 .3 M 05/15/2001 Information has been received concerning a pt was vaccinated on 06/06/00 with several vaccines and on 06/12/00 he developed a rash on his upper right thigh area with a total of 3 lesions noted. the rash was noted as chicken pox appearance with less than 20 vesicles scattered diffusely. The pt also had an injection site wheal. The pt was afebrile and sought unspecified medical attention. On 06/27/00 the pt recovered. Y Y 06/06/2000 06/12/2000 6 PVT PVT UNK WAES00082086 1
0171478 06/01/2001 ME 1.8 1 .2 F 05/15/2001 Inormation has been received concerning a pt who on 09/15/99 was vaccinated with varicella vaccine. On 6/02/00 the pt experienced a breakthrough varicella rash of 20 to 40 lesions. The pt was seen by a physician on 06/01/00. the pt recovered with no further adverse events. Y Y 09/15/1999 06/02/2000 261 PVT PUB UNK UNK WAES00062127 1
0171479 06/01/2001 ME 1.4 3 M 05/15/2001 Information has been received from a physician concerning a pt who was vaccinated on 01/19/00 with varicella vaccine. On 06/06/00 the pt presented with a mild varicella rash of approximately 10 to 15 lesions. The pt recovered with no further adverse experiences. Y Y 01/19/2000 06/06/2000 139 PVT PUB NONE Sulfisoxazole allergy WAES00062128 1
0171480 06/01/2001 PA 6.0 4 F 05/15/2001 Information has been received concerning a pt who on 08/09/97 was vaccinated with one dose of varicella vaccine. On 06/14/2000 the pt experienced a mild pox rash on the abdomen, back, and extremities. She took Benadryl for the itch. She did not feel are act sick. The pt recovered on 06/24/00. 08/09/1997 08/14/2000 1101 OTH OTH UNK Tonsillectomy WAES00062164 1
0171481 06/01/2001 PA 5.0 2 .3 M 05/15/2001 information has been received concerning a pt with varicella exposure on approximately 06/04/00 who in June of 97 had been vaccinated with varicella vaccine. The pt experienced breakthrough chickenpox that consisted of 2 vesicles on 06/14/00. Pt had 11 vesicles on 6/15/00, and 37 vesicles by 06/17/00. Otic temperature was 98.5F. The pt symptoms resolved quickly and he was asymptomatic by 06/19/00. Y Y 06/01/1997 06/14/2000 1109 body temperature 98.5 done by otic measurement OTH OTH UNK varicella exposure WAES00062167 1
0171482 06/01/2001 TX 5.0 5 M 05/15/2001 Information has been received from a consumer concerning her son. One day post vaccination the pt developed an upset stomach. U 06/19/2000 06/20/2000 1 OTH OTH NONE Medical history of febrile seizures WAES00062169 1
0171483 06/01/2001 IL 5.0 1 .0 M 06/15/2001 Information has been received concerning a pt who developed chickenpox like lesions on the trunk post vaccination. The pt denies itching and had no complaints. the pt was recovering on 06/13/00 and it was indicated he did recover. Y 04/24/1996 PVT PVT UNK UNK WAES00062271 1
0171484 06/01/2001 IL 8.0 4 F 05/15/2001 Information has been received concerning a pt who was vaccinated with varicella vaccine on 04/24/96 and on 06/15/2000 the pt developed chickenpox like lesions on her trunk. On an unspecified date the pt recovered. Y 04/24/1996 06/15/2000 1513 PVT PVT UNK UNK WAES00062272 1
0171485 06/01/2001 MO 5.0 1 .5 F 05/15/2001 Information has been received concerning a pt who on 03/27/96 was vaccinated with one dose of varicella vaccine. On 06/49/00 the pt experienced a chickenpox out break. Blisters started in the mouth and on the head. The rash was also on the chest and back. She was diagnosed with varicella and treated with calamine lotion. It was noted her father had shingles 2 weeks prior the pt's onset of chickenpox. Y U 03/27/1996 06/19/2000 1545 PVT OTH UNK medical history of otitis media; concurrent condition: herpes zoster exposure WAES00062343 1
0171486 06/01/2001 MD F 06/15/2001 Information has been received concerning a pt who was vaccinated with varicella vaccine. On 06/07/00 the pt's father developed shingles. Subsequently the pt developed chickenpox consisting of approximately 50-100 lesions. It was noted that the lesions were in the pt's mouth, on her head and generalized. The lesions reportedly went through the full progression from blisters to scabs. Additionally, it was noted that the pt's chickenpox appeared more mild than natural chickenpox and that it seemed to resolve quicker than wild type disease. Unspecified medical attention was sought. Y U 01/02/1996 06/01/2000 1612 UNK UNK UNK herpes zoster exposure WAES00062344 1
0171487 06/01/2001 MI 1.4 M 05/15/2001 Information has been received concerning a pt who was vaccinated with varicella vaccine on 03/06/00. On 06/19/00 the pt presented with a case of chickenpox described as spotty all over. 2 or 3 blistered lesions, and afebrile. There was no known exposure to wild type varicella. Y U 03/06/2000 06/19/2000 105 OTH OTH NONE Amoxicillin allergy WAES00062463 1
0171488 06/01/2001 WV 6.0 2 .6 F 05/15/2001 Information has been received concerning a pt who was vaccinated on 12/31/96 with varicella vaccine. On 06/20/00 the pt experienced a good case of chickenpox with lots of lesions. Unspecified medical attention was sought. It was noted that the pt was afebrile. U 12/31/1996 06/20/2000 1267 OTH OTH NONE NONE WAES00052720 1
0171489 06/01/2001 WV 2.0 1 .9 M 05/15/2001 Information has been received concerning a pt who on 05/10/00 was vaccinated with first dose of varicella vaccine. On 06/16/00, the pt developed a chickenpox rash. the reporter is unsure of number of lesions, however she describes a good rash. the pt sought unspecified medical attention was sought and on an unspecified date the pt recovered. Y Y 05/10/2000 06/19/2000 40 PVT PUB NONE NONE WAES00062721 1
0171490 06/01/2001 PA 25.0 25 F 05/16/2001 Information has been received concerning a pt who was vaccinated June 2000 with the first dose of varicella vaccine. On 06/27/00 the pt developed swollen glands under her left ear. The pt did not seek medical attention. U 06/01/2000 06/22/2000 21 OTH OTH hormonal contraceptives penicillin allergy WAES00082775 1
0171491 06/01/2001 MI 3.0 3 F 05/15/2001 Information has been received concerning a pt who was vaccinated on 05/09/00 with one dose of varicella vaccine. On 06/16/00 the pt experience a papulomacular rash consistent with varicella. The pt recovered on 07/01/00. Y 05/09/2000 06/16/2000 38 UNK UNK UNK UNK WAES00062866 1
0171492 06/01/2001 MI 7.0 2 .9 M 05/15/2001 Information has been received concerning a pt who on 04/09/1996 was vaccinated with first dose of varicella vaccine. On 06/15/00 the pt developed a rash consistent with varicella. It was noted that this experience did not require prescription drug treatment and that the pt's rash is still being treated. Y 04/09/1996 06/15/2000 1528 OTH OTH NONE UNK WAES00062875 1
0171493 06/01/2001 MI 3.0 0 .3 M 05/15/2001 information has been received concerning a pt who was vaccinated on 09/19/98 with his first varicella vaccine. On 05/15/00 the pt developed a maculopapular rash consistent with varicella. At the time of the report 06/20/00 the pt was still being treated for the experience. The pt's brother also experienced a similar event. Follow up information received on 08/24/00 that the pt had recovered by 06/30/00. Y 09/19/1996 05/15/2000 1334 OTH OTH NONE UNK WAES00062878 1
0171494 06/01/2001 PA 2.0 1 .7 M 05/15/2001 Information has been received concerning a pt who was vaccinated on 11/04/99 with first dose of varicella vaccine. On 05/09/00 the pt developed breakthrough varicella with a papular-vesicular rash on his extremities, palms of hands and side of feet and on his palate. On an unspecified date the pt recovered. Y 11/04/1999 05/09/2000 187 PVT PVT UNK UNK WAES00062882 1
0171495 06/01/2001 NY 6.0 1 .7 M 05/15/2001 Information had been received concerning a pt who was vaccinated on 08/06/1995 with varicella vaccine. On 06/23/00 the pt experienced mild fever and a diffuse papular like, small in size pox. He had greater than 100 lesions. Medical attention was sought. Follow up was received from a physician which indicated the pt recovered. Y Y 08/06/1995 06/23/2000 1783 PVT PVT UNK UNK WAES00082950 1
0171496 06/01/2001 CT 6.0 M 05/15/2001 Information has been received concerning a pt who was vaccinated on 11/14/95 with one dose of varicella vaccine. On 06/11/00, the pt developed breakthrough chickenpox with 20-30 lesions, some of which were vesicular. The physician had collected a specimen. The pt sought unspecified medical attention. Follow up information received on 06/26/00 from a physician, indicated that the pt was afebrile throughout the breakout of approximately 30 lesions, mostly small red papules but with some barely scabbed but rather melted away. The physician indicated that she did a gptiter and the child was positive. Follow up information received on 07/03/00 from a woman at Columbia University indicated that the swab of vesicular fluid was negative for VZV and preliminary results from a scab sent is VZV positive wild type. Follow up information received on 09/05/2000 from a physician indicated that a varicella EIA was positive prior to lesions. Fifty papules with vesicles were noted on the pt's nose and back. Y U 11/14/1995 06/11/2000 1671 diagnostic laboratory on 06/15/00 negative varicella antibody titer, diagnostic laboratory on 06/17/00 varicella EIA negative prior to lesions, Deoxyribonuelaic acid on 06/20/00 adequate specimen results were wild type strain VZV positive PVT OTH UNK History of Otitis WAES00062995 1
0171497 06/01/2001 VA 13.0 9 F 05/15/2001 Information has been received concerning a pt who was vaccinated on 02/11/97 was vaccinated with the first dose of varicella. On 06/18/00 the pt developed a rash on body on the left side at approximately T10 dermatosis-herpes zoster at the level of umbilicus. U 02/11/1997 06/15/2000 1220 PVT PVT UNK UNK WAES00063037 1
0171498 06/01/2001 IL 12.0 12 M 06/15/2001 Information has been received concerning a pt who was vaccinated on 06/15/00 with one dose of varicella vaccine. The next day the pt developed induration of 10 cm, erythema and tenderness at the injection site. It was noted that the pt was afebrile. Antibiotic therapy was started as a precautionary measure and the pt recovered about one week later. Y 06/15/2000 06/17/2000 2 NONE PVT PUB UNK NONE WAES00063212 1
0171499 06/01/2001 VT U 06/15/2001 Information has been received concerning a pt who was vaccinated with one dose of varicella vaccine in March 2000. On 06/12/00 the pt was exposed to a child with live varicella. On 06/26/00 the pt developed spots. Unspecified medical attention was sought. Y U 03/01/2000 06/26/2000 117 OTH OTH UNK varicella exposure WAES00063238 1
0171500 06/01/2001 IN 4.0 3 F 05/15/2001 Information has been received from a physician concerning a pt who on 09/17/99 was vaccinated with one dose of varicella vaccine. On 06/19/00 the pt developed chicken pox with 300 lesions noted. Y N 09/13/1999 06/19/2000 280 PVT OTH UNK UNK WAES00063250 1
0171501 06/01/2001 NH 5.0 1 .7 M 05/15/2001 Information has been received concerning a pt who on 12/02/94 was vaccinated with varicella vaccine. There was no concomitant therapy. The pt's Mother reported that on 06/20/00 , the pt developed a breakthrough rash. The reporter indicated that the pt had a good case, but less than 50 lesions, no fever or other symptoms. It was noted the the pt had a varicella like rash. the pt sought unspecified medical attention. On an unspecified date, the pt recovered. Y Y 12/02/1996 06/20/2000 1296 PVT PUB NONE NONE WAES00064354 1
0171502 06/01/2001 MN U 05/15/2001 Information has been received concerning a pt who was vaccinated with varicella vaccine. Two or three weeks post vaccination the pt developed a culture confirmed localized varicella skin rash. Unspecified medical attention was sought. Y U Diagnostic laboratory-culture confirmed localized varicella skin rash. OTH OTH UNK UNK WAES00064356 1
0171503 06/01/2001 PA 2.0 1 .4 M 06/15/2001 Information has been received concerning a pt with no known recent varicella exposure who on 10/15/98 was vaccinated with one dose of varicella vaccine. It was noted that the pt had an upper respiratory infection at the time of vaccination. On 06/27/00 the pt developed 5 red spots with white centers scattered on the right side of his back and itching. The pt's Mother described the spots as looking like pimples. Follow up information from the pt's Mother indicated that the pt's spots are just about gone now. I think he was bitten by a bug. The physician indicated that the pt was never seen at her office. On an unspecified date the pt recovered. Y 10/15/1998 06/27/2000 621 PVT PVT UNK Upper respiratory infection UNK WAES00064368 1
0171504 06/01/2001 IN 6.0 2 .2 F 05/15/2001 Information has been received concerning a pt who was vaccinated on 06/10/96 with varicella vaccine. There was no concomitant medication. On 06/22/00, the pt developed chickenpox that consisted of 10-20 lesions. The pt sought unspecified medical attention. Y U 01/10/1996 06/22/2000 1625 OTH OTH NONE NONE WAES00064425 1
0171505 06/01/2001 VA 0.7 M 05/15/2001 Information has been received concerning a pt who was exposed to his vaccinated sister who had a varicella like rash. This pt had not been vaccinated with varicella vaccine. It was reported that the lesions and a fever started on 06/26/22. On 06/28/00, the pt developed a secondary transmission when he broke out with a full blown case of chickenpox. The pt's parents do not know if exposure to wild type virus occurred. The reporter indicated that a vesicular fluid specimen and a swab will be sent for analysis. The pt sought unspecified medical attention. Follow up information from the laboratory indicated that the results of the pt's test performed on 06/30/00 were negative for varicella zoster. The pt recovered. Y Y 06/26/2000 UNK UNK NONE varicella exposure WAES00064473 1
0171506 06/01/2001 GA 7.0 M 06/15/2001 Information has been received concerning a pt who was vaccinated with one dose of varicella vaccine. In June 2000 the pt developed chicken pox. the pt sought unspecified medical attention. Y U 06/01/2000 OTH OTH UNK UNK WAES00064475 1
0171507 06/01/2001 MA 1.7 1 .1 M 05/15/2001 Information has been received concerning a pt who was vaccinated on 09/29/1999 with varicella vaccine, MMRII, and IPOL. On 06/29/00 the pt developed a case of chickenpox with about 10 vesicles that was described as a mild case of varicella. The reporter indicated that she was unsure if pt had a fever or if exposure to a wild type. The pt sought unspecified medical attention. In 07/00 the pt recovered. Y Y 09/29/1999 06/28/2000 273 PVT PUB Medical history of otic infection, and concurrent condition of a heart murmur WAES00064491 1
0171508 06/01/2001 AZ 2.0 3 M 05/15/2001 Information has been received concerning a pt who on 06/01/00 was vaccinated with the first dose of varicella. On 06/11/00, the pt developed several pustulant red bumps on his torso and face. On 06/15/00 the pt recovered from his experience. Y 06/01/2000 06/11/2000 10 OTH OTH UNK UNK WAES00064511 1
0171509 06/01/2001 AZ 5.0 3 F 06/15/2001 Information has been received concerning a pt who on 12/09/97 was vaccinated with her first dose of varicella vaccine. On 06/12/00 the pt developed classic varicella with teardrop lesion, erythematous base and differing stages of healing. Follow up information received on 08/23/00 indicated the pt recovered. Y 12/09/1997 06/12/2000 916 PVT PUB UNK UNK WAES00064513 1
0171510 06/01/2001 NJ 38.0 38 F 06/15/2001 Information has been received concerning a pt who 06/27/00 was vaccinated with one dose of varicella vaccine. On 06/29/00 the pt developed lesions. The lesions were on both arms and the left side of her neck. The pt later developed vesicles on the right thigh and chest. the pt sought unspecified medical attention and was treated with Atarax. On 07/08/00 the pt developed redness, itching and swelling of approximately 5 cm at the injection site. On 07/14/00 the pt recovered from her symptoms. Y Y 06/27/2000 06/29/2000 2 PVT PVT UNK UNK WAES00064635 1
0171511 06/01/2001 MO F 05/15/2001 Information has been received from a female nurse who was vaccinated with a second dose of varicella vaccine. Subsequently the pt did not have any detectable antibody levels to varicella one month after her second dose. Y U Diagnostic laboratory -negative varicella antibody titer OTH OTH UNK UNK WAES00064839 1
0171512 06/01/2001 IN M 05/15/2001 Information has been received concerning a pt who on 12/01/97 was vaccinated with varicella vaccine. On 06/22/00, the pt developed chickenpox. The pt was covered with marks. The pt sought unspecified medical attention. Y U 12/01/1997 06/22/2000 934 UNK UNK NONE NONE WAES00064575 1
0171513 06/01/2001 MI 1.0 1 .0 M 05/15/2001 Information has been received concerning a pt with bronchitis and sinusitis at the time of vaccination. On 06/12/00 he was vaccinated with the first dose of varicella vaccine. On 06/23/00 the pt developed a fever, rash, and maculopapaular lesions. The pt sought unspecified medical treatment and the physician noted consistent with varicella. On 07/07/00 the pt recovered. Y Y 06/13/2000 06/23/2000 10 PUB PVT Ventolin, Amoxil bronchitis; sinusitis UNK WAES00064748 1
0171514 06/01/2001 OH 4.0 1 .1 M 06/15/2001 Information has been received concerning a pt who on 06/17/1996 was vaccinated with a first dose of varicella vaccine. In April 2000 the pt experienced breakthrough chickenpox consisting of greater than 100 lesions. It was noted that the pt's experience did not require prescription drug treatment. On an unspecified date the pt recovered. Y 06/17/1996 04/01/2000 1384 OTH OTH NONE UNK WAES00084749 1
0171515 06/01/2001 M 05/15/2001 Information has been received concerning a pt who was vaccinated in 12/99 with varicella vaccine. In 06/2000 the pt reported tested positive for herpes. U 12/01/1999 06/01/2000 183 Diagnostic laboratory 06/01/2000 tested positive for herpes OTH OTH UNK UNK WAES00070014 1
0171516 06/01/2001 OH 2.0 0 1 F 05/15/2001 Information has been received concerning a pt who was vaccinated on 07/15/99 with her first dose of varicella vaccine. On 06/30/00 the pt broke out with spots of chickenpox scattered all over her body. the pt sought unspecified medical attention. Y U 07/15/1998 06/30/2000 716 NONE PVT OTH NONE NONE WAES00070029 1
0171517 06/01/2001 NC 1.2 1 .2 M 05/15/2001 Information has been received concerning a pt who on 06/09/00 was vaccinated with the first dose of varicella vaccine, first dose of MMRII. Subsequently, the pt developed a red rash. Follow up information indicated that the pt broke out in a rash around 7-10 days post vaccination. the rash persisted for around 2 weeks. The reporting physician indicated that maybe a rash secondary to vaccine itself and not an adverse reaction. Follow up information from the pt's mother that after 2 days of receiving varicella vaccine her son was experiencing very painful sores around the rectum. They began to heal and then flare up again. They have seen several doctors, but have not been able to identify the cause or remedy for the sores. They suggested that it may be some kind of allergy. Follow up information received from the pt's current treating physician indicated that the pt had received his vaccination from a different health care provider prior to her having seen him. The physician saw him for the first time on 09/06/00, and she saw him for the first time for an erosive diaper dermatitis which resolved over the next 4-6 weeks. The pt had a history of constipation and she felt that his diaper dermatitis was secondary to over flow of stool with skin irritation, because the child was not under her direct care at time of vaccination she did not feel she could report on the problems of his first reported experienced. Y Y 06/09/2000 06/11/2000 2 NONE OTH OTH medical history -constipation and concurrent conditions food allergy WAES00070030 1
0171518 06/01/2001 CA 1.4 1 .3 M 05/15/2001 Information has been received concerning a pt who on 04/28/00 was vaccinated with his first dose of varicella vaccine. It was noted that the pt's mother felt that the pt moved and did not receive the full amount of varicella vaccine. the pt sought unspecified medical attention and on 06/16/00 a titer was done resulting in negative immunity. Y U 04/28/2000 06/16/2000 49 diagnostic laboratory done on 06/16/00 , value 0.8, a normal range >1.0 results in negative titer UNK UNK NONE WAES00070043 1
0171519 06/01/2001 TX U 05/15/2001 Information has been received concerning a pt who on 06/27/00 was vaccinated with one dose of varicella vaccine. On 06/30/00, the pt experienced difficulty breathing and sought medical attention at the physician office. Y U 06/27/2000 06/30/2000 3 OTH OTH UNK UNK WAES00070045 1
0171520 06/01/2001 VA 5.0 5 F 05/15/2001 Information has been received concerning a pt who on 03/09/2000 was vaccinated with the first dose of varicella vaccine. On 03/19/2000 the pt developed chickenpox. On 03/20/2000 the pt was examined by a physician who confirmed that the patient had chickenpox with approximately 50 lesions scattered face, trunk extremities and vulva. Y U 03/03/2000 03/19/2000 16 PVT PVT UNK penicillin allergy WAES00070189 1
0171521 06/01/2001 NY 1.3 1 .3 M 06/15/2001 Information has been received from a father concerning his son who on 06/24/00 was vaccinated with one dose of varicella vaccine. On 07/01/00 the pt developed a rash all over his body "like a blanket" and a fever of 101 F. The father noted that the pt was also rubbing his eyes. On an unspecified date the fever resolved, however, the rash continues. the pt did not seek medical attention. N 06/24/2000 07/01/2000 7 OTH OTH UNK eczema WAES00070195 1
0171522 06/01/2001 MI 1.02 1 .0 M 05/15/2001 Information has been received from a registered nurse concerning a pt who on 09/08/99 was vaccinated with several vaccines. In June 99 the pt broke out with a few lesions and experienced a runny nose and low grade fever. Unspecified medical attention was sought. It was reported that the pt's symptoms lasted for a few days. the patient is recovered. Follow up information reported that the pt developed a breakthrough disease with 10-22 pox noted. On an unspecified date the pt recovered. Y Y 09/08/1999 NONE PUB PUB NONE WAES00070206 1
0171523 06/01/2001 WA 5.0 3 U 05/15/2001 Information has been received concerning a pt who on 01/12/99 was vaccinated with one dose of varicella vaccine. On 07/03/00 the pt developed visible lesions and on 07/05/00 had a full outbreak of chickenpox. The pt sought unspecified medical attention. Y U 01/12/1999 07/30/2000 565 OTH OTH UNK UNK WAES00070234 1
0171524 06/01/2001 CO U 05/15/2001 Information has been received concerning a pt who was vaccinated with varicella vaccine. Subsequently the pt experienced breakthrough disease (varicella). it was noted that prescription drug treatment was not required for the outbreak. The pt recovered. Y OTH OTH NONE UNK WAES00070282 1
0171525 06/01/2001 CO U 05/15/2001 Information has been received concerning a pt who was vaccinated with varicella vaccine. Subsequently the pt experienced breakthrough disease (varicella). The pt recovered. Y OTH OTH NONE UNK WAES00070283 1
0171526 06/01/2001 OR 36.0 36 F 05/15/2001 Information has been received concerning a pt who on 6/26/00 was vaccinated with the first dose of varicella vaccine. On 07/02/00 the pt experienced two puruitic, erythematous, macular lesion on the right posterior shoulder. The pt also developed a lesion on the upper lip and on chin, nose, left knee, and right inguinal fold, all of which were reported to be puruitic. The physician saw the pt on 07/06/00 and as of that date, she had four lesions remaining. These lesions were throbbing with pain. The pt reported that the lesion on her nose was draining slightly serous fluid. As of 07/06/00 the pt did not have any vesicular lesions. All the lesions left were macular papular. These 2 lesions resolved within 48 hours. In July 2000, the pt experienced headache and mild nausea. The physician discussed the case with another physician and they both felt that the rash was not a typical varicella rash, though neither know exactly what the rash was. F/U 6/17/02 revealed there was no record of this pt. However, it was noted "to date all pts experiencing adverse reactions to varicella virus vaccine live, through this clinic, have recovered fully". No further info is available. Y Y 06/26/2000 07/02/2000 6 OTH OTH UNK seasonal allergy Measles~Measles + Mumps + Rubella (MMR II)~~15.00~In Patient|~Measles + Mumps + Rubella (MMR II)~~0.00~In Sibling WAES00070374 1
0171527 06/01/2001 NH 1.75 3 F 05/15/2001 Information has been received concerning a pt who was vaccinated on 10/19/1999 with one dose of varicella vaccine. The pt's mother reported that on 06/26/00, the pt developed a varicella like rash. The nurse saw the pt and she had less than 50 lesions. it was also reported that information about exposure to wild type varicella was unknown at this time. Medical attention was sought. Y U 10/19/1999 06/26/2000 251 UNK UNK NONE NONE WAES00070376 1
0171528 06/01/2001 OK 35.0 35 F 05/15/2001 Information has been received concerning a pt who 06/30/00 was vaccinated with varicella vaccine. The pt also had MMRII. Within 24 hours post vaccination the pt developed a full blown rash. Her arm was red and hot and she had a bumpy rash on her stomach, back and between her breast. It was noted that it did not look like a typical chickenpox. On 07/02/00 the area around the injection site became worse, it looked like an orange peel. The pt went to ER and was told by a physician that it was a vaccine reaction. The arm she had the MMRII in was normal. She was given NSAIDS, Vistaril shot and a Medrol dose pak. the pt stated that within 2 hours of the cortisone injection in the ER she noted a marked improvement. The pt recovered on on 07/05/2000 Y Y 06/30/2000 07/01/2000 1 Tuberculin skin test on 06/29/00 results not reported UNK UNK Lortab, Albuterol, Soma, Adipex-P, Theo-dur penicillin and sulfa allergy WAES00070387 1
0171529 06/01/2001 AR 4.0 F 05/15/2001 Information has been received concerning her daughter who on 07/03/00 was vaccinated intramuscularly with one dose of varicella vaccine. This does not comply with the recommended route of administration. In July 2000 the pt developed a headache, a low grade fever of 100.5 and vomiting. The pt sought unspecified medical attention. Y U 07/03/2000 07/03/2000 0 Body temperature measurement was 100.5 F OTH OTH UNK UNK WAES00070400 1
0171530 06/01/2001 MA 1.0 0 1 M 05/15/2001 Information has been received concerning her 12 month old son who in June of 2000 was vaccinated with varicella vaccine. Subsequently the pt developed a case of varicella. The pt's mother indicated that her son had 10 lesions on his body at the following sites: face, arm and legs. It was noted that medical attention was sought. Y U 06/01/2000 06/01/2000 0 OTH OTH UNK UNK WAES00070401 1
0171531 06/01/2001 MI U 05/15/2001 Information has been received from a registered nurse concerning a pt who was vaccinated with varicella vaccine. One week post vaccination the pt developed a chickenpox like rash over whole body. Unspecified medical attention was sought. Y U OTH OTH UNK UNK WAES00070403 1
0171532 06/01/2001 VA 4.0 4 F 05/15/2001 Information has been received from a RN concerning a pt who on 05/31/00 with varicella vaccine. On 06/13/00 the pt developed a varicella like rash on her upper back and neck and it was noted that 14 days post-vaccination, the pt was covered from head to toe. The pt's parents do not know if exposure to wild type virus occurred. the reporter indicated that a vesicular fluid specimen and a swab will be sent for analysis. the pt sought unspecified medical attention. Follow up information received from the RN indicated that the PCR analysis was negative for varicella zoster virus. It was reported that the pt has recovered. Y Y 05/31/2000 06/13/2000 13 deoxyribonucleic acid-PCR was negative PVT OTH NONE NONE ~Varicella (Varivax)~~0.70~Sibling|~Varicella (Varivax)~~0.70~Sibling WAES00070459 1
0171533 06/01/2001 FL F 05/15/2001 Information has been received from a LPN concerning a adult female pt who was vaccinated with a first and second dose of varicella vaccine. Subsequently the pt's laboratory results indicated a varicella antibody titer of 0.2. The pt sought unspecified medical attention. Y U serum varicella zoster value 0.2 results -lack of seroconversion OTH OTH UNK UNK UNK WAES00070515 1
0171534 06/01/2001 MA 5.0 5 M 05/15/2001 Information has been received concerning a pt who on 03/26/99 was vaccinated with a first dose of varicella vaccine. On 07/07/00 the pt developed a mild case of chicken pox. the pt sought unspecified medical attention. Follow information received indicated that the pt was exposed to varicella on 07/02/00, broke out with 4 -5 vesicles on the clavicular area bilaterally and small papules on the right thumb were noted. It was reported the pt recovered. Y Y 03/26/1999 07/07/2000 469 NONE PVT PUB varicella exposure WAES00070563 1
0171535 06/01/2001 F 05/15/2001 Information has been received from the mother of a pt who in November and December 99 was vaccinated with one dose of varicella vaccine. Subsequently, the pt did not develop antibodies. Additionally, the pt's mother noted that her daughter has recently been diagnosed with juvenile rheumatic arthritis. The pt sought unspecified medical attention. Y U 12/01/1999 serum varicella zoster results were negative varicella antibody titer OTH OTH UNK UNK WAES00070583 1
0171536 06/01/2001 NY 33.0 F 05/15/2001 Information has been received from a physician concerning his 33 year old pregnant wife. (LMP 01/24/00) who had chickenpox as a child, and whose son was vaccinated with one dose of varicella vaccine. Subsequently, the pt's son developed shingles, and approximately 3.5 weeks afterwards in 07/2000 the pregnant wife developed shingles as well. The wife's shingles were noted to be on the right side of her nose. Y Y OTH OTH WAES00070590 1
0171574 06/01/2001 NY 2.0 2 .0 M 05/15/2001 Information has been received concerning his son who was vaccinated with with varicella vaccine first dose. In May or June 2000 his son experienced a mild case of shingles with vesicular patch on his left buttock. The rash appeared vesicular with a dermatomal distribution of L5/S1. There were dozens of lesions. He noted that the child was afebrile and had no other systemic symptoms. it was indicated that the pt did not have any recent exposure to natural chickenpox or shingles and that a rash did not occur at the site of injection or elsewhere within 42 days of the vaccination. Additionally, it was reported that the lesions have healed. The pt sought unspecified medical attention. Y Y 12/27/1999 05/01/2000 126 Body temp was afebrile , 2 deoxyribonucleic acid tests, 1 swab and 1 scab specimens were inadequate to process PVT UNK NONE NONE WAES00070663 1
0171575 06/01/2001 KY 5.0 5 M 05/15/2001 Information has been received concerning a pt who was vaccinated with varicella vaccine and Prevnar on 06/30/00. On 07/08/00 the pt developed an apparent varicella rash, low grade fever, and small reaction at the injection site. The pt's mother noted pox all over his body, but the reporter noted less than 50. The pt sought unspecified medical attention. Y U 06/30/2000 07/08/2000 8 OTH OTH UNK WAES00070705 1
0171576 06/01/2001 IN 18.0 1 .0 M 05/15/2001 Information has been received concerning a pt who was vaccinated on 09/13/99 with his first dose of varicella vaccine. On 07/03/00 the pt's mother notified the physician's office to report that her son had 18 pox. U 09/13/1999 07/30/2000 321 PVT PVT UNK NONE WAES00070898 1
0171577 06/01/2001 OH 5.0 3 M 05/15/2001 Information has been received concerning a pt who was vaccinated on 07/22/98 with varicella vaccine. On 07/03/00 the pt broke out with chickenpox. It was noted that the pt had 9-10 scabbed lesions and was afebrile. Unspecified medical attention was sought. Follow up information from an RN reported that on 07/18/00 the pt recovered. Y Y 07/22/1998 07/08/2000 717 PVT UNK NONE NONE WAES00070972 1
0171578 06/01/2001 OH 5.0 F 05/15/2001 Information has been received concerning a pt who in approximately January of 1999 was vaccinated with varicella vaccine. Subsequently, the pt developed chickenpox four different times. With each outbreak she had been exposed to wild type virus and the lesions did not scab. the lesions did come to a head and resolved within a couple of days. The pt sought unspecified medical attention. Y Y OTH OTH UNK varicella exposure WAES00071044 1
0171579 06/01/2001 MA 9.0 9 M 05/15/2001 Information has been received concerning a pt who on 04/11/00 was vaccinated with varicella vaccine. On 07/13/00, the pt experienced over 100 lesions, mostly on his trunk, a few on scalp, face and neck and a fever of 103 F. The pt was taken to the ER. It was noted that all but a single lesion are scabbed over. One lesion on a toe was vesicular, but appeared not clear but more pustular. There was nothing associated with the lesions. A sample was taken and it was positive for wild type varicella zoster virus. Follow up information from a NP indicated that the pt was fully recovered and was fine 3 weeks after breakthrough varicella. Y Y 04/11/2000 07/13/2000 93 Deoxyribonucleic acid on 07/14/2000 at Columbia University PCR; results positive for wild type VZV PVT PUB NONE NONE WAES00071045 1
0171580 06/01/2001 OR U 05/15/2001 Information has been received concerning a pt who was vaccinated with one dose of varicella vaccine. It was reported to the pharmacist from a RN that the vaccine bubbled around the needle at injection site and 10 percent of the vaccine was lost. This does not comply with the recommended dosage schedule. The pt sought unspecified medical attention. the pt has since been lost to follow up. Y U OTH OTH UNK UNK WAES00071092 1
0171581 06/01/2001 GA 5.0 1 .2 M 05/15/2001 Information has been received concerning a pt who was vaccinated 07/96 with varicella vaccine. On 07/11/2000 the pt was seen in the physician's office with greater than 25 lesions and was diagnosed with chickenpox. It was noted that the pt only complained of itching and was afebrile. He was treated with Atarax and acyclovir. On 07/26/2000 the pt recovered. Y Y 07/01/1996 07/11/2000 1471 OTH OTH UNK NONE WAES00071096 1
0171582 06/01/2001 4.0 F 05/15/2001 Information has been received from a company representative concerning a patient who in approximately 1997 was vaccinated with varicella virus vaccine live. Subsequently, the patient experienced breakthrough chickenpox. It was also reported that 4 children at the patient's daycare had a similar experience following exposure to varicella virus vaccine live. Additional information has been requested. Follow up information from the RN indicated the adverse experience occurred in the daycare nearby the office, and she had no additional information on this adverse experience. The physician's office did not administer any of the vaccines. No further information is expected. U OTH OTH UNK UNK WAES00071166 1
0171583 06/01/2001 CO 1.0 M 05/15/2001 Post vax, on 06/05/2000 the patient developed a rash of vesicular lesions. On 06/06/2000 the patient was seen by a physician. The physician felt that the patient "must have been exposed to natural varicella to have developed a rash so quickly." The patient's mother denies exposure to natural varicella. At the time of reporting the patient continued to develop 3-4 pox every day. Additionally it was noted that the patient's mother and father also developed similar experiences. Additional information has been requested. Y U 06/03/2000 06/05/2000 2 OTH OTH UNK UNK WAES00071206 1
0171584 06/01/2001 TX 5.0 F 05/15/2001 Information has been received from a company representative concerning a patient who in approximately 1997 was vaccinated with varicella virus vaccine live. Subsequently the patient experienced breakthrough chicken pox. It was also reported that 4 children at the patient's daycare had a similar experience following exposure to varicella virus vaccine live. Follow up information from the registered nurse indicated that the adverse experience occurred at a local daycare who indicated that there have been several cases of breakthrough varicella in the past weeks or couple of months. At least 4 children have had active lesions and all have retrieved varicella virus vaccine live in the past. It was reported that the physician's office did not administer any of the vaccines. No further information is available. U OTH OTH UNK UNK WAES00071272 1
0171585 06/01/2001 4.0 U 05/15/2001 Information has been received from a company representative concerning a patient who was vaccinated with varicella virus vaccine live. Subsequently the patient experienced breakthrough chicken pox. It was also reported that 4 children at the patient's daycare had a similar experience following exposure to varicella virus vaccine live. Additional information has been requested. U OTH OTH UNK UNK WAES00071273 1
0171586 06/01/2001 4.0 1 .0 M 05/15/2001 Information has been received from a company representative concerning a patient who on 02/19/1997 was vaccinated with varicella virus vaccine live. Subsequently the patient experienced breakthrough chicken pox. It was also reported that 4 children at the patient's daycare had a similar experience following exposure to varicella virus vaccine live. Additional information has been requested. U 02/19/1997 UNK UNK UNK UNK WAES00071274 1
0171587 06/01/2001 TX 3.0 2 .3 U 05/15/2001 Information has been received from a company representative concerning a patient who on 05/01/2000 was vaccinated with varicella virus vaccine live. Subsequently the patient experienced breakthrough chicken pox. It was also reported that 4 children at the patient's daycare had a similar experience following exposure to varicella virus vaccine live. Follow up information from the registered nurse indicated that this was a breakthrough case of chickenpox. It was reported that the physician's office did not administer any of the vaccines. No further information is available. U 05/01/2000 OTH OTH UNK UNK WAES00071275 1
0171588 06/01/2001 VA 1.0 1 .0 M 05/15/2001 On 06/23/2000 the patient experienced a "full blown case of varicella. The lesions were too numerous to count, concentrated in the hair and groin, but also over the abdomen, chest, back, arms, and legs." It was reported that the patient recovered. Per F/U 6/17/02: On 10/13/99 was vaccinated SC, in the right arm, with a 1st dose of varicella virus vaccine (lot 631475/1003J). The NP reported that although the pt has an extensive cardiac history and is "fragile", he has been "growing beautifully" and has no known immunocompromise. It was reported that the pt started wheezing on 10/25/99 and was dx'd with a right lower lobe pneumonia. The pt subsequently recovered from the pneumonia. From 11/19/98 until 5/99, the pt was enrolled in the Synagisis RSV vaccine cardiac safety trial, which was a multicenter placebo-controlled blinded study. It was unknown if the pt received Synagis or placebo, however on 12/18/99, the pt developed respiratory syncytial virus and recovered completely from his RSV. On 6/23/00, the pt experienced a "full blown case of varicella. The varicella lesions were too numerous to count, concentrated in the hair and groin, but also over the abdomen, chest, back, arms and legs". It was reported that the pt recovered. F/U info from the NP indicated that on 6/23/00, the pt had a full blown case of chicken pox. As of 6/28/00, it was reported that the lesions were clearing and subsequently, the pt recovered. No further info is expected. Y Y 10/13/1999 10/25/1999 12 CXR-11/17/99-right lower lobe pneumonia PVT OTH UNK Otic infection; aortic subvalvular stenosis; hypoplasia; ventricular septal defect; mitral valve stenosis; Per F/U 6/17/02-aortic arch hypoplasia WAES00071279 1
0171589 06/01/2001 NM 1.2 1 .1 F 05/15/2001 In July 2000 the patient experienced blisters "on the forehead and tummy". Medical attention was sought. No further information is available. Y U 07/11/2000 07/11/2000 0 OTH OTH UNK UNK WAES00071341 1
0171590 06/01/2001 IL 5.0 0 .1 F 05/15/2001 On 07/14/2000, the patient developed chickenpox that consisted of less than 30 lesions over her entire body and the patient was afebrile. The patient sought unspecified medical attention. Follow up information from a physician indicated that the patient's symptoms included "scattered, small, vesicular lesions on a red base on the patient's trunk and face." The patient was diagnosed with "possible varicella versus other viral exanthema." Subsequently, the patient recovered. Y Y 01/16/1995 07/14/2000 2006 PVT PVT UNK UNK WAES00071368 1
0171591 06/01/2001 CA 1.08 0 .9 M 05/15/2001 On 07/15/2000, the patient developed a "generalized vesicular rash that consisted of more than 100 lesions. The physician noted that this was the worse case of breakthrough, or even wild type, that she has seen. The patient was afebrile and had no exposure to wild type virus" Follow up information from a physician reported that the patient was seen in the office on 07/17/2000 and it was noted that some of the lesions had crusted. On 08/01/2000 the patient recovered. No further information is expected. Y Y 07/07/2000 07/15/2000 8 PVT PUB NONE WAES00071363 1
0171592 06/01/2001 CO F 05/15/2001 Information has been received from a health care professional concering a patient who was exposed to her 1-year-old son who was vaccinated with 1 dose of varicella virus vaccine live. On approximately, 06/12/2000 the mother developed a rash with greater than 50 lesions. Additionally, it was noted that the father also developed a similar reaction. Additional information has been requested. Y U 06/12/2000 OTH OTH UNK UNK WAES00071403 1
0171593 06/01/2001 CO M 05/15/2001 Information has been received from a health care professional concerning a patient who in approximately December, 1999 was vaccinated with one dose of varicella virus vaccine live. In June, 2000 the patient developed a rash after exposure to his son. Additionally it was noted that the patient's wife experienced a similar reaction. Additional information has been requested. Y U 12/01/1999 06/01/2000 183 OTH OTH UNK UNK WAES00071404 1
0171594 06/01/2001 GA 4.0 3 M 05/15/2001 On 04/03/2000 the patient experienced chickenpox with 10 lesions. Subsequently, the patient recovered from chickenpox. Medical attention was sought. No further information is available. Y Y 08/20/1998 04/03/2000 592 OTH OTH UNK UNK WAES00071472 1
0171595 06/01/2001 GA 1.0 1 .0 M 05/15/2001 On 06/21/2000 the patient developed 4 chickenpox lesions and a muculopapular "base" rash on his trunk. Unspecified medical attention was sought. Subsequently, the patient recovered. No further information is expected. Y Y 06/12/2000 06/21/2000 9 UNK UNK UNK NONE WAES00071473 1
0171596 06/01/2001 CA 4.0 F 05/15/2001 Information has been received from a licensed visiting nurse concerning a patient who in January 1997 was vaccinated with 1 dose of varicella virus vaccine live. On 07/06/2000 the patient developed itchy lesions on her torso and mostly over the face. It was noted that the patient was afebrile. Unspecified medical attention was sought. Additional information has been requested. Y U 01/01/1997 07/06/2000 1282 OTH OTH NONE UNK WAES00071521 1
0171597 06/01/2001 VT 34.0 M 05/15/2001 Information has been received from a RN concerning a patient that tested nonimmune to varicella and who on 06/28/2000 was vaccinated with varicella virus vaccine live. On 07/16/2000 the patient experienced a chickenpox like rash. The patient is very concerned about this in that at least one other family member, a brother received the vaccine and developed chickenpox and quickly thereafter shingles. The patient stated that he does not have any known immunodeficiency and is very worried since he works with the public. The patient sought unspecified medical attention. Additional information has bee requested. Y U 06/28/2000 07/16/2000 18 serum varicella zoster - nonimmune OTH OTH UNK UNK ~Varicella (Varivax)~~30.00~In Sibling|~Varicella (Varivax)~~30.00~In Sibling WAES00071611 1
0171598 06/01/2001 PA 23.0 23 M 05/15/2001 Twenty-two days post vaccination, the patient developed a chicken pox-like rash with less than 50 pox. The rash resolved spontaneously. The rash was associated with a low grade fever and myalgia. The patient was also resolving a case of onychomycosis. Y Y 06/26/2000 07/17/2000 21 UNK UNK Keflex; Flonase; ibuprofen; onychomycosis; UNK WAES00071616 1
0171599 06/01/2001 OK 5.0 F 05/15/2001 Post vax, the patient developed what "appears" to be chicken pox. Unspecified medical attention was sought. Additional information has been requested. Y U 05/30/1997 OTH OTH UNK UNK WAES00071670 1
0171600 06/01/2001 FL 28.0 28 F 05/15/2001 On 07/20/2000 the patient experienced "attenuated breakthrough chickenpox" on her face, back and arms. Unspecified medical attention was sought. Additional information has been requested. Y U 06/28/2000 07/20/2000 22 OTH OTH NONE UNK WAES00071802 1
0171601 06/01/2001 VT 30.0 M 05/15/2001 The patient was vaccinated in approximately 1999. It was reported that in approximately July of 2000, the patient "presented with a chickenpox-like rash and shingles after his brother was vaccinated. The patient's brother had a similar experience following exposure to varicella virus vaccine live. The patient sought unspecified medical attention. Additional information has been requested. Y U UNK UNK UNK UNK ~Varicella (Varivax)~~34.00~In Sibling WAES00071888 1
0171602 06/01/2001 GA 5.0 1 .7 F 05/15/2001 On 07/16/2000 the patient developed chickenpox without complications. Unspecified medical attention was sought. It was reported that the patient subsequently recovered. Y Y 05/14/1996 07/16/2000 1524 UNK UNK UNK NONE WAES00071991 1
0171603 06/01/2001 KY 11.0 11 F 05/15/2001 On 07/22/2000, the patient developed half dollar size redness, tenderness, swelling, induration and heat at the injection site. It was reported that the patient was afebrile. The patient sought unspecified medical attention. Additional information has been requested. Follow up information from the NP indicated that the rash developed on 07/21/2000. The patient was seen by the physician on 07/25/2000. Subsequently on 08/01/2000, it was reported that the patient recovered. No further information is expected. Y Y 07/12/2000 07/21/2000 9 PVT PVT UNK NONE WAES00072243 1
0171604 06/01/2001 SC 1.08 1 .1 F 05/15/2001 On 04/07/1998 the patient developed a fever and rash. The patient received treatment with therapy of Atarax and recovered. In July, 2000 the patient developed breakthrough chickenpox with approximately 15 lesions. She was afebrile at that time. It was unknown if the child was exposed to wild type virus. The patient sought unspecified medical attention. The child has since recovered. No further information is expected. Y Y 03/10/1998 04/07/1998 28 NONE PVT PVT NONE NONE WAES00072355 1
0171605 06/01/2001 CA 31.0 30 F 05/15/2001 The patient was vaccinated 07/19/2000. Subsequently, the patient learned that she was pregnant. It was noted that the patient's husband developed shingles and that the patient was tested for varicella antibodies on 06/29/2000 and the result was negative. On 08/01/2000, it was reported that the patient has developed "3 pock marks that she thinks might have been chickenpox". The patient sought unspecified medical attention. Additional information has been requested. This report is part of the pregnancy registry. F/U 6/17/02: received from an MA reported that on 7/31/01, the pt delivered a healthy, full term male, 8lbs 1oz (39 weeks from LMP) via normal delivery. The pt had no complications during labor/delivery. The infant did not have any feature of congenital varicella zoster syndrome. Additional info has been requested. Y U 07/19/2000 08/01/2000 13 Serum varicella zoster - negative PVT OTH Prozac; vitamins; Herpes zoster exposure; Pregnancy (LMP-6/13/00); Per F/U 6/17/02-depression WAES00072428 1
0171606 06/01/2001 NY U 05/15/2001 Information has been requested from a physician concerning an adult patient who on an unspecified date was vaccinated with a second dose of varicella virus vaccine live. Subsequently, the patient tested negative for antibodies to varicella virus vaccine live. The patient sought unspecified medical attention. Additional information has been requested. Y U Serum varicella zoster - negative OTH OTH UNK UNK WAES00072457 1
0171607 06/01/2001 NY 1.25 M 05/15/2001 Post vax, in July 2000 the patient developed erythema multiforme. Unspecified medical attention was sought. Additional information has been requested. Y U 07/11/2000 OTH OTH NONE NONE WAES00072463 1
0171608 06/01/2001 AZ 1.08 U 05/15/2001 Information has been received from a LPN concerning a patient who was vaccinated with a first dose of varicella virus vaccine live. Four to five days post vax, the patient developed erythema multiforme. Unspecified medical attention was sought and the patient's experience was thought to be an allergy and treated at the time of the occurrence. The patient had a similar experience following exposure to MMR vaccine. Additional information has been requested. Y U OTH OTH UNK UNK erythema multiforme minor~Measles + Mumps + Rubella (MMR II)~~1.00~In Patient WAES00072512 1
0171609 06/01/2001 MO 26.0 26 F 05/15/2001 Information has been received from a health care facility concerning a patient who was vaccinated with a first and second dose of varicella virus vaccine live on 01/19/2000 and 03/13/2000, respectively. Concomitant vaccinations included a 4th dose of hepatitis B vaccine on 01/05/2000. TB skin tests performed on 01/05/2000 and 03/28/2000 were negative. On 04/28/2000 the patient's diagnostic lab tests indicated that the varicella zoster IgC and rubella titer were negative. Additional information has been requested. Y U 03/13/2000 04/28/2000 46 Serum varicella zoster - negative; rubella - negative; PVT OTH tuberculin skin test - negative UNK WAES00072526 1
0171610 06/01/2001 IL 1.5 1 .5 F 05/15/2001 On 07/27/2000 the patient developed redness and 3 pustules at the injection site. The physician had not been contacted at the time of the report. Additional information has been requested. U 07/18/2000 07/27/2000 9 OTH OTH UNK NONE WAES00072583 1
0171611 06/01/2001 GA U 05/15/2001 Information has been received from a health care facility concerning an unidentified patient who in approximately July 2000, was vaccinated with a dose of varicella virus vaccine live. Subsequently, in July of 2000, the patient developed a questionable varicella like rash. The patient sought unspecified medical attention. It was reported that 2 other children and in the same health care facility experienced a similar experience following exposure to varicella virus vaccine live. A lot check query was requested by the health care facility. Additional information has been requested. Y U 07/01/2000 07/01/2000 0 OTH OTH UNK UNK WAES00072595 1
0171612 06/01/2001 NC 0.3 M 05/15/2001 On 07/20/2000 the patient was exposed to a child who had developed typical chickenpox spots following vaccination with varicella virus vaccine live. On 07/26/2000 the patient had a secondary transmission and developed chickenpox which was described as a rash and 10-12 little pox spots on his head, forehead, face, neck, ears and trunk in different stages and had a low grade fever, 99.8F. The patient ran a fever for a week. On 08/02/2000 the patient was seen in the physician's office and it was noted the rash was resolved but the fever returned with irritability and poor intake. On 08/02/2000 the patient was noted to be teething. On 08/05/2000 the patient developed some drainage from the eyes, a low grade fever and an upper respiratory infection. The patient was treated with a topical decongestant. On 08/17/2000 the patient's temperature was 101.7F. On 08/18/2001 the patient had a cold, cough, nasal congestion, profuse purulent nasal discharge, a poor appetite and a fever of 99.2F. The physician diagnosed a fairly severe upper respiratory infection with a history of otitis media. The patient was treated with Amoxil, Tylenol and fluids. It was noted that during the time the patient had his spots he was around an adult white male who was diagnosed the second week of September, 2000 with shingles. No further information is available. Per F/U 6/17/02; on 8/2/00, the pt was vaccinated with a 2nd dose of Hib (lot 601063A) in the right thigh, a 2nd dose of Triedia (lot U00566A) in the left thigh, the 2nd dose of Engerix-B (lot 3300B2) in the right thigh and the 2nd dose of IPOL (lot P1232) in the left thigh. On 8/28/00, the pt had nasal congestion. The physician's impression was that the pt had bilateral otitis media, upper respiratory infection and reflux. The pt received treatment with Augmentin, Rondec drops, Tylenol as needed and saline nose drops. The pt stopped taking Rondec drops and started taking Otrivin pediatric nose drops, Zantac and Reglan. It was noted that in 8/00, the pt recovered. On 9/7/00, the pt's resipratory illness was much improved but continued to spit up after feeding. On 9/8/00, the pt was noted to have congestion, spitting up, not drinking well, refusing to drink his bottle and low-grade fever. It was noted that his congestion was doing much better. The physician's impression was that the pt had GERD and resolved otitis. The pt continued on Reglan and Zantac with a pediatric Gastroenterology referral considered if symptoms do not improve. No further info is available. Y Y 07/26/2000 Upper GI series X-ray - mild reflux 8/30/02; Per F/U 6/17/02; temp measurements-99.2F to 101.7F PVT PVT Secondary transmission and developed chickenpox on 7/26/00 and had a low-grade fever for a week with irritability and poor intake until 8/1/00. Appetite decreased; crying; gastroesophageal reflux disease; otitis; upper respiratory infection; vomiting; premature delivery; lacrimal duct occlusion; dental disorder; varicella exposure WAES00072611 1
0171613 06/01/2001 TX 1.0 1 .1 M 05/15/2001 On 05/25/2000 the patient developed a red, macular and papular eruption over his face, chest, abdomen, upper and lower back and diaper area. There was no pruritus. The rash appeared immediately after the fever subsided. The patient was treated with Benadryl and the patient recovered. The patient had a similar experience following hepatitis b vaccine. Y 06/22/2000 06/26/2000 4 CBC - wnl UNK UNK Viral syndrome; fever NONE petochial rash~Hep B (Recombivax HB)~1~0.00~In Patient WAES00072884 1
0171614 06/01/2001 CA 11.0 U 05/15/2001 Information has been received concerning a patient who was vaccinated with varicella virus vaccine live. Four months post-vaccination, the patient was diagnosed by a dermatologist with "symptoms of shingles". A relative of the patient had a similar experience following exposure to the patient. Additional information has been requested. Y U OTH OTH UNK UNK WAES00080188 1
0171615 06/01/2001 TN 1.3 1 .1 M 05/15/2001 On 07/28/2000 the patient developed varicella vesicles over his entire body. The patient was also vomiting. On 07/31/2000, the patient was seen by a physician and diagnosed with chickenpox. On 08/10/2000 the patient recovered. Y Y 04/13/2000 07/28/2000 106 UNK UNK NONE fungal rash NONE WAES00080198 1
0171616 06/01/2001 TX 6.0 0 1 F 05/15/2001 On 08/01/2000 the patient developed a "mild case" of chickenpox. The patient sought unspecified medical attention. Also reported was a male patient who was vaccinated and experienced similar events. Additional information has been requested. Y U 05/09/1995 08/01/2000 1911 OTH OTH UNK UNK WAES00080214 1
0171617 06/01/2001 GA U 05/15/2001 Information has been received from a health care facility concerning and an unidentified patient who in approximately July 2000, was vaccinated with a dose of varicella virus vaccine live. Subsequently, in July of 2000, the patient developed a questionable varicella like rash. The patient sought unspecified medical attention. It was reported that 2 other children in the same health care facility experienced a similar experience following exposure to varicella virus vaccine live. A lot check query was requested by the health care facility. Additional information has been requested. Y U 07/01/2000 07/01/2000 0 OTH OTH UNK UNK WAES00080255 1
0171618 06/01/2001 GA U 05/15/2001 Information has been received from a health care facility concerning an unidentified patient who in approximately July 2000, was vaccinated with a dose of varicella virus vaccine live. Subsequently, in July 2000, the patient developed a questionable varicella like rash. The patient sought unspecified medical attention. It was reported that 2 other children in the same health care facility experienced a similar experience following exposure to varicella virus vaccine live. A lot check query was requested by the health care facility. Additional information has been requested. Y U OTH OTH UNK UNK WAES00080258 1
0171619 06/01/2001 CT 1.2 1 .1 F 05/15/2001 On 04/25/2000 the patient experienced herpes zoster on the right thigh in a linear distribution. The patient was afebrile. Subsequently, the patient recovered. There had been no recent exposure to chickenpox or to shingles. PCR analysis indicated the vesicular specimen from the herpes zoster rash was adequate, however it was negative for VZV. No further information is available. Y Y 03/01/2000 04/25/2000 55 DNA - specimen negative for VZV OTH OTH NONE NONE WAES00080287 1
0171620 06/01/2001 IL 2.0 1 .0 M 05/15/2001 On 07/31/2000 the patient experienced chickenpox, approximately 30 lesions. He also experienced a low grade fever. Medical attention was sought. Subsequently, the patient recovered. No further information is available. Y Y 01/11/1999 07/31/2000 567 PVT PVT UNK WAES00080355 1
0171621 06/01/2001 CA U 05/15/2001 Information has been received from a company representative concerning an unidentified patient who was exposed to a younger relative who was vaccinated with varicella virus vaccine live. It was reported that the relative "developed a condition that "might" or "could have" been contracted by the young child's symptoms of zoster. Additional information has been requested. U OTH OTH UNK Varicella exposure herpes zoster~Varicella (Varivax)~2~0.00~In Patient WAES00080417 1
0171622 06/01/2001 TX 3.0 M 05/15/2001 Information has been received from a RN concerning a patient who in approximately 1999, at the age of 18 months, was vaccinated with one dose of varicella virus vaccine live. On 08-01-2000, the patient developed "quite a few lesions and a fever". The patient sought unspecified medical attention. Also reported was a female patient who was vaccinated and experienced similar events. Additional information has been requested. Y U 08/01/2000 UNK UNK UNK UNK WAES00080424 1
0171623 06/01/2001 PA 5.0 5 F 05/15/2001 Information has been received from a physician concerning a patient who was exposed to "natural varicella" 11 days prior to vaccination and was vaccinated with one dose of varicella virus vaccine live on 07/24/2000. Subsequently, the patient "started to develop some scattered chickenpox" accompanied by a 99.8F fever. The patient was formally diagnosed with chickenpox on 08/03/2000 and placed on Zovirax. The patient has recovered. Y Y 07/24/2000 08/03/2000 10 PVT PVT UNK Varicella exposure; WAES00080483 1
0171625 06/01/2001 NY 6.0 4 F 05/15/2001 On 07/30/2000, the patient developed breakthrough chicken pox, and broke out with the rash and approximately 150 blisters. As of 08/07/2000 it was reported that she now only has a little over 100 scabs, the others seem to have disappeared without ever having reached a big blister-scabbing stage. Also, she endured quite a lot of pain for about 2 days to the point of screaming at the top of her lungs in agony. No itching was noted. It was reported that the patient recovered from pain. A lot check was done and no problems were found. Additional information has been requested. Follow up information from the physician indicated that on 07/31/2000 at 07:30 am, the patient developed a mild case of chickenpox. It was reported that there were greater than 100 spots, full blisters with no complications and the patient was febrile. Subsequently, the patient recovered. No further information is expected. Y Y 06/08/1998 07/31/2000 784 OTH PVT Allergy WAES00080532 1
0171626 06/01/2001 OK 1.0 1 .0 F 05/15/2001 Seven days post vax, the patient developed an ear infection and was treated with Amoxil. Within 48 hours, the patient developed a rash all over her body and a low grade temperature. The patient's treatment was changed from Amoxil to Benadryl. The patient developed swelling of her ears, hands, legs, arms and head with itching. The patient was also treated with Tylenol. The rash was described as clear in the center "ring worm like" and the patient also had swelling in her joints and at times did not walk. The rash lasted 7 days. The patient was not given any new foods during this time. The rash continues to come and go. The patient sought unspecified medical attention. Follow up information received 08/29/2000 from a physician indicated that on 06/28/2000 the patient broke out with hives all over her body, experienced swelling which lasted 1 week and a low grade fever. On an unspecified date, the patient recovered. No further information is expected. Y Y 06/21/2000 06/28/2000 7 NONE PVT OTH Amoxil NONE WAES00080704 1
0171627 06/01/2001 FL F 05/15/2001 Information has been received from a female nurse who was vaccinated with 2 doses of varicella virus vaccine live. Subsequently, the patient had a negative titer. The patient then received 2 more doses of varicella virus vaccine live and had a positive IgG 3 weeks after the second dose in the second series. Unspecified medical attention was sought. Additional information has been requested. Y Y Serum varicella zoster - positive titer after 4th dose. OTH OTH UNK UNK WAES00080753 1
0171628 06/01/2001 NC 1.08 1 .1 M 05/15/2001 Post vax, the patient experienced a "hypersensitivity reaction" described as "swelling and redness at the injection site which spread to his chest". The patient was treated with ibuprofen and Benadryl. It was also noted that the patient also broke out with "a few pox". Follow up information from a registered nurse indicated that there is no additional information. Y U 08/04/2000 08/04/2000 0 OTH OTH UNK UNK WAES00080760 1
0171629 06/01/2001 NY 25.0 25 F 05/15/2001 On 08/02/2000 the patient developed a blister with swelling at the injection site. On 08/04/2000 the patient experienced a fever of 102F. The patient took Tylenol and the fever resolved in 2 days. It was reported that the injection site blister persisted. Follow up information from a physician reported that on 08/04/2000 "conservative management" was suggested to the patient. The patient did not return for follow up since that time. No further information is expected. N 07/18/2000 08/02/2000 15 OTH OTH NONE NONE WAES00080780 1
0171630 06/01/2001 OR U 05/15/2001 Information has been received form a RN concerning a patient who was vaccinated with varicella virus vaccine live. Subsequently, the patient experienced a vesicular rash. Medical attention was sought. The patient was restricted from work for one week. The patient received a second dose with no side effects noted. No further information is available. Y Y OTH OTH UNK UNK WAES00080876 1
0171631 06/01/2001 NY F 05/15/2001 Information has been received from a company representative concerning a patient who was vaccinated with one dose of varicella virus vaccine live. Subsequently, the patient developed "vaccine virus". The patient sought unspecified medical attention. Additionally it was reported that the patient's aunt also developed a "full blown case". Additional information has been requested. Y U OTH OTH UNK UNK WAES00080923 1
0171632 06/01/2001 NY U 05/15/2001 Information has been received from a vaccine specialist concerning an unidentified child patient who was vaccinated with varicella virus vaccine live. The serum varicella zoster virus antibody test was done and "the patient failed to seroconvert". Unspecified medical attention was sought. Follow up information from the physician indicated that this is not an adverse experience because "she cannot be sure that that patient did not seroconvert because there is no commercially available test for varicella vaccine antibodies. The commercially available tests test for wild type antibodies." It was reported that a sibling in the patient's household has leukemia. Additional information has been requested. Y U Serum varicella zoster - failed seroconversion OTH OTH UNK UNK WAES00080987 1
0171633 06/01/2001 NJ 2.0 1 .0 F 05/15/2001 On 08/06 or 08/07/2000 the patient was diagnosed with multiple open scratched varicella lesions, and no known fever. The patient had a rash on her legs with multiple open scratched areas. It was noted that the patient had vomited one day prior to vaccination and had rhinitis at the time of vaccination. The patient sought unspecified medical attention. On an unspecified date, the patient recovered. No further information is available. Y Y 01/21/1999 08/06/2000 563 NONE PVT PVT Rhinitis; vomiting; UNK WAES00080988 1
0171634 06/01/2001 CA 16.0 14 M 05/15/2001 Information has been received from a RN concerning a patient who at the age of 14, was vaccinated subcutaneously in the left arm with a first dose and in the right deltoid with a second dose of varicella virus vaccine live on 05/01/1997 and 06/25/1997, respectively. On 12/16/1999, the serum varicella zoster virus antibody test was performed and the results were negative. Unspecified medical attention was sought. Follow up information received on 11/08/2000 indicated that the patient was vaccinated subcutaneously in the left arm with a third dose of varicella virus vaccine live. Additional information has been requested. Y U 06/25/1997 12/16/1999 904 Serum varicella zoster - results negative PVT OTH UNK UNK WAES00081006 1
0171635 06/01/2001 CA 27.0 F 05/15/2001 Information has been received from a physician concerning a patient who on an unspecified date was vaccinated with the first dose of varicella virus vaccine live. Subsequently, the patient did not trigger an immune response. The patient's titer was "zero". The patient sought unspecified medical attention. Additional information has been requested. Y U Serum varicella zoster - Negative OTH OTH NONE NONE WAES00081031 1
0171636 06/01/2001 MA 2.0 M 05/15/2001 In approximately June 2000 the patient was vaccinated with varicella virus vaccine live. On 08/09/2000 the patient broke out in a full blown case of chicken pox, more than 50 lesions. It was reported that another patient has a similar reaction after exposure to varicella virus vaccine line. Unspecified medical attention was sought. Additional information has been requested. Y U 08/09/2000 OTH OTH UNK Varicella WAES00081128 1
0171637 06/01/2001 MA 4.0 M 05/15/2001 The patient was vaccinated with a dose of varicella virus vaccine live. Subsequently, in March 1999 the patient developed shingles. Unspecified medical attention was sought. It was reported that another patient had a similar experience following exposure to varicella virus vaccine live. Y U 01/01/1997 03/01/1999 789 OTH OTH UNK Varicella WAES00081131 1
0171638 06/01/2001 SC 1.0 1 .0 F 05/15/2001 On 08/09/2000 the patient experienced mild case of chicken pox. The patient sought unspecified medical attention. Follow up information from the RN indicated that on 08/09/2000, the patient's mom called the physician's office and reported "red bumps". The patient was seen by the physician and was questioning insect bites. It was reported that on 08/10/2000, the patient's father reported an increase in the number of bumps and he thinks that it is chickenpox. The father declined to have the patient come to the physician's office for a visit. The nurse reported that the patient subsequently recovered on an unspecified date. No further information is expected. Y Y 07/27/2000 08/09/2000 13 PVT PVT NONE WAES00081142 1
0171640 06/01/2001 TX 2.0 1 .0 F 05/15/2001 On 08/07/2000, the patient developed a "varicella lesion on soft palate, erythema, vesicles, papules and pustules on her face, scalp, trunk, and extremities. Additional information has been requested. U 04/12/1999 08/07/2000 483 PVT PVT Naldecon UNK WAES00081259 1
0171641 06/01/2001 U 05/15/2001 Information has been received from a company representative concerning an unidentified child patient who was vaccinated with varicella virus vaccine live. Subsequently, 12 days after receiving the vaccine the patient presented to an ER with "20 or so papular lesions and itching". No fever or rash was present. Additional information has been requested. Follow up information from the health care facility indicated that this patient is unknown to the physician's office. No further information is expected. Y U UNK UNK UNK UNK WAES00081261 1
0171642 06/01/2001 NH 3.0 1 .3 F 05/15/2001 On 08/09/2000 the patient developed approximately 50 chicken pox lesions on the torso and face. The patient sought unspecified medical attention. Additional information has been requested. Y U 07/28/1998 08/09/2000 743 OTH OTH UNK UNK WAES00081278 1
0171643 06/01/2001 NJ 8.0 4 M 05/15/2001 Post vax, the patient developed chicken pox on his buttocks, chest and legs. The patient sought unspecified medical attention. Follow up information from the RN indicated that on 08/11/2000 the patient developed a pruritic rash with 20 erythematous papules and vesicles on his buttocks and both legs. It was reported that subsequently, the patient recovered. No further information is expected. Y Y 08/17/1995 08/11/2000 1821 PVT PVT NONE WAES00081289 1
0171644 06/01/2001 NJ 6.0 1 .5 M 05/15/2001 On 08/10/2000 or 08/11/2000 patient developed chicken pox on genitals, legs and arms which was described as an itchy rash with an unknown number of lesions. The patient sought unspecified medical attention. On 08/21/2000 the patient recovered. Also reported was the patient's sibling who was vaccinated and received similar events. Follow up information from a RN reported that in an unspecified date the patient recovered. No further information is available. Y Y 07/26/1995 08/10/2000 1842 PVT PVT NONE NONE ~Varicella (Varivax)~~8.00~In Sibling|~Varicella (Varivax)~~8.00~In Sibling WAES00081298 1
0171645 06/01/2001 OR F 05/15/2001 On 08/07/2000 the patient developed an "approximately one to two inch circle at the injection site with red spots in the center, but no blisters. The affected area was also itchy. Additional information has been requested. U 07/25/2000 08/07/2000 13 PVT PVT UNK UNK WAES00081335 1
0171646 06/01/2001 NC F 05/15/2001 Information has been received from a registered pharmacist concerning an unidentified female patient who was vaccinated with a first and second dose of varicella virus vaccine live on 08/24/1999 and 09/24/1999, respectively. The serum varicella zoster virus antibody test was done recently, in approximately August 2000, and the patient does not have detectable antibodies. Unspecified medical attention was sought. Additional information has been requested. Y U 09/24/1999 08/01/2000 312 serum varicella zoster - no antibody OTH OTH UNK UNK WAES00081389 1
0171647 06/01/2001 CA 1.0 1 .0 M 05/15/2001 Subsequently, 2 weeks after vaccination, the patient was "experiencing ataxia". The patient sought unspecified medical attention. Follow up information from the physician indicated from 08/09/2000 to 08/10/2000 the patient developed a fever to 102F. Briefly on 08/11/2000 only, 3-4 red spots were noted on her face, neck and back. From 08/09/2000 to 08/16/2000 the patient experienced unsteadiness, was "wobbly" and falling more than usual. The patient had a normal exam on 08/11/2000. Subsequently as of 08/16/2000, it was reported that the patient had no symptoms, was doing well and recovered. No further information is expected. Y Y 07/31/2000 08/09/2000 9 Physical examination - normal exam PVT PVT UNK WAES00081394 1
0171648 06/01/2001 MD 1.0 F 05/15/2001 Approximately one week after vaccination the patient developed a disseminated rash with no fever and minimal itching. The patient sought unspecified medical attention. It was noted that a physician diagnosed varicella. Additional information has been requested. U OTH OTH UNK UNK WAES00081619 1
0171649 06/01/2001 NJ 40.0 F 05/15/2001 Information has been received on a patient who was vaccinated with two doses of varicella virus vaccine live and failed to seroconvert. Unspecified medical attention was sought. Follow up information from a physician indicated that there was "no immunological response-titers negative. The patient did not have any adverse experiences. Y U serum varicella zoster - titer negative OTH OTH UNK Sulfa allergy WAES00081628 1
0171650 06/01/2001 NJ 42.0 42 F 05/15/2001 Information has been received from a RN concerning a patient who was vaccinated with a first and second dose of varicella virus vaccine live on 04/21/2000 and 05/18/2000, respectively. The serum varicella zoster virus antibody test was done on 08/09/2000 and it indicated that the patient was "non-immune" to varicella zoster. The patient sought unspecified medical attention. No further information is expected. Y U 05/18/2000 08/09/2000 83 Serum varicella zoster - non-immune to varicella zoster UNK UNK UNK Hypertension; hypothyroidism; WAES00081630 1
0171651 06/01/2001 FL 29.0 29 F 05/15/2001 Post vax, the patient felt "ill" with achiness for about one month. The patient sought unspecified medical attention. Additional information has been requested. Y U 01/27/1999 OTH OTH UNK UNK WAES00081643 1
0171652 06/01/2001 F 05/15/2001 Information has been received from a consumer concerning his daughter who in approximately 1998 was vaccinated with a dose of varicella virus vaccine live. Subsequently in approximately July 2000, the patient developed a slight case of chickenpox and developed shingles 3 weeks after having had the chicken pox. It was reported that the patient's sister had a similar experience following exposure to varicella virus vaccine live. Additional information has been requested. U OTH OTH UNK UNK ~Varicella (Varivax)~~0.00~In Sibling WAES00081899 1
0171653 06/01/2001 VA 28.0 F 05/15/2001 Information has been received from a NP concerning a patient who was vaccinated with one dose of varicella virus vaccine live. Subsequently, the patient had a negative titer. The reporter did not consider this an adverse event. The patient sought unspecified medical attention. Additional information has been requested. Y U serum varicella zoster - negative OTH OTH UNK UNK WAES00081740 1
0171654 06/01/2001 TX 1.0 1 .0 M 05/15/2001 On 08/14/2000 the patient experienced a "breakthrough rash of approximately 8-10 lesions". It was noted that the patient was afebrile and had "no other adverse effects". The patient's twin sister was also vaccinated on the same day and did not develop a rash. Follow up information from a health care professional reported that the patient had 10-15 pustules at most and that on an unspecified date recovered from the rash. No further information is expected. Y 08/04/2000 08/14/2000 10 NONE PVT OTH NONE Allergy WAES00081780 1
0171655 06/01/2001 TX 3.0 1 .5 M 05/15/2001 On 07/31/2000 the patient developed a mild case of chickenpox with fever and numerous shallow lesions. The patient sought unspecified medical treatment. Additional information has been requested. Y U 12/04/1998 07/31/2000 605 PVT PVT Asthma WAES00081838 1
0171656 06/01/2001 F 05/15/2001 Information has been received from a consumer concerning his daughter who in approximately 1998 was vaccinated with a dose of varicella virus vaccine live. Subsequently, in approximately July 2000, the patient developed a slight case of chickenpox. It was reported that the patient's sister had a similar experience following exposure to varicella virus vaccine live. Additional information has been requested U OTH OTH UNK UNK ~Varicella (Varivax)~~0.00~In Sibling|~Varicella (Varivax)~~0.00~In Sibling WAES00081845 1
0171657 06/01/2001 MN 1.9 M 05/15/2001 Information has been received from a LPN concerning a patient who was vaccinated with one dose of varicella virus vaccine live. Subsequently the patient experienced a rash. No further information is available. U OTH OTH UNK UNK WAES00081870 1
0171658 06/01/2001 IN 18.0 17 F 05/15/2001 Post vax, the patient developed a "lesion rash". The patient sought unspecified medical attention. Follow up information from the physician indicated that the patient broke out with 2 or 3 lesions about 10 days after vaccination. It was reported that the physician did not consider this to be an adverse experience. No further information is expected. Y U 08/07/2000 08/17/2000 10 PUB PUB UNK UNK WAES00082000 1
0171659 06/01/2001 NE 5.0 F 05/15/2001 Information has been received concerning a patient who was vaccinated with a dose of varicella virus vaccine live. Subsequently, the patient "broke out with an unspecified rash". The patient sought unspecified medical attention. Additional information has been requested. Y U OTH OTH UNK UNK WAES00082016 1
0171660 06/01/2001 CA F 05/15/2001 Information has been received from a RN concerning an unidentified female patient who was vaccinated with a first dose of varicella virus vaccine live. Subsequently, the patient developed a couple of vesicles. The patient sought unspecified medical attention. Additional information has been requested. Y U OTH OTH UNK UNK WAES00082036 1
0171661 06/01/2001 FL 28.0 F 05/15/2001 Information has been received from a company representative concerning a patient who in September of 1999 was vaccinated with one dose of varicella virus vaccine live. The patient sought unspecified medical attention. Additional information has been requested. Y U 09/01/1999 07/25/2000 328 Immunoglobulin G index - negative; serum immunoglobulin M - positive; OTH OTH UNK UNK WAES00082085 1
0171662 06/01/2001 1.5 M 05/15/2001 Eleven days post vax, the patient developed a mild case of chickenpox. Several days post-onset, the patient recovered. In the beginning of August 2000, the patient developed a severe rash "that started off looking like chickenpox; however, it then developed into welts all over his entire body and face. The rash cleared up after 1 week. The patient was treated with Prelone and Benadryl. The rash reappeared and the patient was seen by a physician who thought the patient may have experienced a reaction to the varicella virus vaccine. No further information is available. Y Y 06/21/2000 07/02/2000 11 Screened for food allergies - negative UNK UNK UNK UNK WAES00082080 1
0171663 06/01/2001 GA 3.0 M 05/15/2001 Post vax, in August 2000, the patient developed a generalized rash. The patient sought unspecified medical attention. Additional information has been requested. Y U 08/11/2000 OTH OTH UNK UNK WAES00082133 1
0171664 06/01/2001 NY U 05/15/2001 Information has been received from a company representative concerning a patient who was vaccinated with 1 dose of varicella virus vaccine live. Subsequently, the patient developed shingles. It was noted that this was third hand information and no additional information was provided. Additional information has been requested. U OTH OTH UNK UNK WAES00082138 1
0171665 06/01/2001 PA 20.0 15 F 05/15/2001 Information has been received from a LPN regarding a patient who on 08/15/1995 and 09/26/1995 was vaccinated with the first and second doses of varicella virus vaccine live. On 08/09/2000 laboratory evaluation revealed a lack of response. Medical attention was sought. No further information is available. Y U 09/26/1995 08/09/2000 1779 serum varicella zoster - 0.12 OTH OTH NONE UNK WAES00082163 1
0171666 06/01/2001 OR 1.0 1 .0 F 05/15/2001 On 06/09/2000 the patient experienced red, raised nickel sized bumps at the injection site. No further information is available. U 06/01/2000 06/09/2000 8 PVT PVT UNK UNK WAES00082233 1
0171667 06/01/2001 TX 8.0 8 F 05/15/2001 On 08/15/2000 the patient developed a rash over her chest, abdomen and both arms. The patient's mother described the rash as "red dots under the skin", not varicella-like. The patient had no fever and was treated with Caladryl. The patient sought unspecified medical attention. On 08/28/2000 the school nurse reported that the patient was at school feeling fine and the rash disappeared after 3 hours on 08/25/2000. On 08/30/2000 the mother reported the patient had red swollen areas on her arms with no fever, and the red area was noted to be approximately 1.5 inch in diameter. Subsequently it was reported that the patient recovered. Y Y 08/17/2000 08/25/2000 8 UNK UNK UNK WAES00082898 1
0171668 06/01/2001 NC 1.7 1 .0 F 05/15/2001 On 08/25/2000 the patient developed herpes zoster. She was seen in the physician's office on 08/28/2000. It was noted that the herpes zoster was a "serious case". The clustered red bumps spanned from the patient's neck to the patient's thumb on the left arm. It was noted the patient did not have a fever. It was noted that the patient did not develop a rash at the site of injection or elsewhere within 42 day of vaccination. Follow up information from a physician's assistant reported that on an unspecified date the patient recovered. Y Y 12/07/1999 08/25/2000 262 immunologic blood workup - results not reported; DNA - inadequate specimen OTH OTH UNK NONE WAES00082838 1
0171669 06/01/2001 1.5 1 .0 F 05/15/2001 Post vaccination, the patient experienced mild chickenpox. Another patient was reported with a similar experience. No further information is available. U 08/26/1996 OTH OTH UNK UNK WAES00082851 1
0171670 06/01/2001 PA 2.0 M 05/15/2001 In 1999, at 12 months of age, the patient was vaccinated with a dose of varicella virus vaccine live. On 08/28/2000 it was reported that the patient is breaking out with chicken pox. The patient sought unspecified medical attention. Additional information has been requested. Y U 08/28/2000 OTH OTH Cromolyn asthma WAES00082862 1
0171671 06/01/2001 TX 47.0 F 05/15/2001 Information has been received from a RN with a history of natural varicella during childhood, who on 08/03/2000 was inadvertently splashed on the right arm when administering a does of varicella virus vaccine live. The nurse did not wipe the vaccine off right away. On 08/11/2000 the nurse developed 6-7 vesicles on her right arm. Additionally, it was reported that the nurse felt itchy that evening. It was noted that the veiscles lasted 5-7 days and resolved without complications. The nurse indicated that she did not see a physician. No further information is available. Y 08/11/2000 NONE OTH OTH UNK varicella WAES00082867 1
0171672 06/01/2001 PA 28.0 1 .4 M 05/15/2001 On 08/13/2000 the patient developed an eruption of chickenpox which continued to appear 7 to 3 pox each day until 08/24/2000. It was noted to be itchy. On 08/15/2000 the patient was seen in the physician's office to confirm chickenpox and was noted to have a few red bumps. Follow up information received 09/27/2000 from a physician indicated that on 08/30/2000, the patient recovered. No further information is expected. Y Y 08/28/1999 08/13/2000 351 PVT PVT Ventolin, Tubersol reactive airway disease WAES00082889 1
0171673 06/01/2001 PA 10.0 10 M 05/15/2001 On 08/24/2000 the patient developed a rash consistent with erythema multiforme 3 days post-vaccination. The patient sought medical attention from a physician for diagnosis. It was noted that the event was self-limited with no sequelae. No further information is expected. Y Y 08/22/2000 08/24/2000 2 PVT PVT NONE NONE WAES00082890 1
0171674 06/01/2001 ME 1.0 1 .0 M 05/15/2001 On 08/09/2000, the patient developed 5-6 lesions on his anterior left forearm, only 1 of which was vesicular. The lesions were raised and resemble mosquito bites. Subsequently, the patient recovered. The reporter stated a concern about the lot. Five additonal patients had similar experienced following exposure to varicella virus vaccine live. Unspecified medical attention was sought. Additional information has been requested. Y Y 07/31/2000 08/09/2000 9 OTH OTH UNK UNK WAES00082951 1
0171675 06/01/2001 CT 17.0 16 F 05/15/2001 On 08/23/2000 the patient developed "itchy" spots around her waist. It was noted that it was an itchy rash of papules 2mm-5mm that was on the waist circumferentially and on the right thigh and left neck. The physician stated the lesions go completely around the patient's waist and she does not fell they are herpes zoster. It was noted that the patient had 50 lesions and a temperature of 98.6F. It was also noted that the worst symptoms were on day 2. Over the past several days, the patient has continued to develop additional lesions around her waist, on her right leg and on her left neck; however, she has not developed and vesicular lesions. On 08/29/2000 the physician saw the patient and she just has "large erythematous and hyperpigmented" areas, but no vesicles. the patient reports the lesions are very itchy, but otherwise she feels fine. She has no reported fever or any other symptoms. Of interest is that the patient may have had a possible exposure to varicella prior to developing her rash. The patient's coworker who had never been immunized, also developed a rash on the same day, and very similar to the patient's. The coworker was diagnosed with chickenpox. On an unspecified date the patient recovered. Additional information has been requested. Y Y 03/29/1999 08/23/2000 513 DNA - inadequate OTH OTH NONE tonsillitis, varicella exposure WAES00083010 1
0171676 06/01/2001 WI U 05/15/2001 Information has been received from a physician concerning unidentified children who were vaccinated with varicella virus vaccine live. The physician indicated that his ER colleagues feel that they are seeing more cases of zoster in the vaccine recipients. Unspecified medical attention was sought. Additional information has been requested. Y U OTH OTH UNK UNK WAES00083022 1
0171677 06/01/2001 NY F 05/15/2001 On approximately 08/21/2000, it was reported that the patient developed chickenpox. The patient sought unspecified medical attention, however it was reported that the child was not seen by the physician. It was reported that a sibling had a similar experience following exposure to varicella virus vaccine live. It was also reported that another sibling in the patient's household has leukemia. Additional information has been requested. Y U 04/19/1999 08/21/2000 490 OTH OTH NONE UNK varicella~Varicella (Varivax)~~6.00~In Patient|~Varicella (Varivax)~~7.00~In Sibling WAES00083042 1
0171678 06/01/2001 RI 7.0 4 M 05/15/2001 In August 2000, the patient developed shingles on his torso and down his leg. He was seen by his physician who initially diagnosed him with a rash and on a second visit, diagnosed his with shingles. The patient had severe pain which started 08/25/2000 and was treated with Tylenol with codeine and an unspecified cream. On 08/31/2000, a sample was sent for PCR analysis. Follow up information states the patient developed sever zoster with hundreds of vesicles, confluent in many areas, distributed on the right abdomen, back and upper thigh with an abrupt stop at midline. The patient was stated to have severe pain. It was reported that the patient has not had recent exposure to chickenpox or shingles. By 09/28/2000 the patient had completely recovered from the experience. The physician reported that some scarring was noted. No further information is expected. Y Y 05/22/1997 08/25/2000 1191 DNA - PCR - positive for OKA strain VZV PVT PUB NONE WAES00083073 1
0171679 06/01/2001 MI 3.0 3 M 05/15/2001 On 08/29/2000 the patient experienced a fever and pain the leg for 3 days. The patient was seen by a physician. Follow up was received from a physician. On approximately 09/12/2000 the patient experienced a nonvesicular rash. It was also reported the patient's brother experience an unspecified adverse event after each does of diphtheria toxoid + pertussis vaccine + tetanus toxoid vaccine. No further information is available. Y U 08/29/2000 08/29/2000 0 PVT OTH NONE NONE ~DTP (no brand name)~0~0.00~In Sibling WAES00083098 1
0171680 06/01/2001 M 05/15/2001 Information has been received from a consumer concerning her son who was vaccinated with one dose of varicella virus vaccine live. Subsequently, the patient developed little red bumps. Subsequently, the patient recovered from the little red bumps. No further information is expected. Y OTH OTH UNK UNK WAES00083132 1
0171681 06/01/2001 M 05/15/2001 Information has been received from a consumer concerning her son who was vaccinated with varicella virus vaccine live. Over a year post vaccination, the patient developed "little red bumps" in different parts of his body and that went away after a day. No further information is available. Y OTH OTH UNK UNK WAES00083137 1
0171682 06/01/2001 ME 31.0 31 F 05/15/2001 On 08/23/2000, approximately 12 days after her son developed a rash, the patient developed a rash described as "5-6 lesions below her ribs, 3 lesions on her back and a number of lesions on both arms, behind her ear, and at the base of her hairline. There was a total of 25-30 lesions." The lesions were itchy and resembled mosquito bites. Subsequently, the patient recovered. The reporter stated a concern about the lot (632043/1360J). Five additional patients had similar experiences following exposure to varicella virus vaccine live. Additional information has been requested. Y Y 05/25/2000 08/23/2000 90 UNK UNK hormonal contraceptives Urticaria WAES00083143 1
0171683 06/01/2001 ME 8.0 F 05/15/2001 Information has been received from a licensed practical nurse concerning a patient with no known history of chickenpox or prior varicella virus vaccination who was exposed to 2 friends who were vaccinated with varicella virus vaccine live and subsequently developed lesions. On 08/26/2000, the patient developed "a maculopapular rash, with some vesicles. The patient had 18 lesions, reported as itchy." The nurse thought the patient may have some scabbed lesions remaining. The patient also experienced general malaise and irritability. Three additional patients had similar experiences following exposure to varicella virus vaccine live. Follow up information indicated that a specimen has been sent for PCR analysis and the results were negative for varicella zoster virus. Additional information has been requested. Y U 08/26/2000 DNA - Columbia PCR results - negative for VZV OTH OTH UNK NONE WAES00083144 1
0171684 06/01/2001 ME 1.25 1 .2 F 05/15/2001 On approximately 08/08/2000, the patient developed "an itchy, mild rash, consisting of 2 lesions on her shoulder". The lesions have scabbed over and the nurse believes the patient recovered. The reporter states a concern about the lot (632042/1360J). Five additional patients had similar experiences following exposure to varicella virus vaccine live. Additional information has been requested. Y Y 07/25/2000 08/08/2000 14 OTH OTH UNK Otitis media ~Varicella (Varivax)~~5.00~In Sibling|~Varicella (Varivax)~~5.00~In Sibling WAES00063145 1
0171685 06/01/2001 ME 5.0 3 M 05/15/2001 Information has been received from a LPN concerning a patient who was vaccinated on 04/06/1998. On 08/25/2000, after the patient's sister was vaccinated with varicella virus vaccine live on 07/25/2000, the patient developed a maculopapular rash that included less than 20 lesions on his arms, legs and back. Some of the lesions had reportedly crusted and scabbed over. The patient also experienced lethargy and a fever. After being seen by a physician it was felt that the patient's symptoms were not chickenpox, "but were consistent with duck itch, which is a term used to describe mite bites that children get when swimming in water inhabited by ducks. 4 additional patients had similar experiences following exposure to varicella virus vaccine live. Follow up information indicated that a specimen was sent for PCR analysis and the results were negative for varicella zoster virus. Additional information has been requested. Y N 04/06/1998 07/25/2000 841 DNA - Columbia PCR results negative for VZV OTH OTH UNK Otitis media ~Varicella (Varivax)~~5.00~In Sibling|~Varicella (Varivax)~~5.00~In Sibling WAES00083148 1
0171686 06/01/2001 ME 3.0 2 .5 M 05/15/2001 On 07/25/2000, the patient developed a maculopapular rash that included greater than 30 lesions on his arms, legs, abdomen, and back. Some of the lesions were reported crusted and scabbed over. The patient also developed a fever and lethargy. After being seen by a physician it was felt that the patient's symptoms were not chickenpox, "but were more consistent with duck itch, which is a term used to describe mite bites that children get when swimming in water inhabited by ducks." Four additional patients had similar experiences following exposure to varicella virus vaccine live. Follow up information indicated that a specimen was sent for PCR analysis, however, the specimen was inadequate to process. Additional information has been requested. Y N 04/13/1998 07/25/2000 834 DNA - Columbia PCR results - inadequate specimen OTH OTH UNK Otitis media ~Varicella (Varivax)~~3.00~In Sibling|~Varicella (Varivax)~~3.00~In Sibling WAES00083147 1
0171687 06/01/2001 GA 1.0 1 .0 F 05/15/2001 On 08/25/2000 the patient began to develop a rash. The patient's mother reports that she had a lot of pain in the area of the lesions. On 08/31/2000 the patient was diagnosed with herpes zoster. The lesions are on the right side of the patient's chest and extend to the right back area. The patient has a low grade fever, 99-100F, a reddened throat, and a tiny spot above one of her eyelids. The patient was treated with acyclovir. It was noted that the patient has no known recent exposure to varicella or shingles. Follow up information received on 08/31/2000 from a NP indicated that the patient did not experience a post vaccination rash at the site of the injection. The patient's lesions were described as maculopapular herpetic lesions, which were erythematous and too numerous to count. It was noted that systemic symptoms included: pharyngitis, mild anorexia, mild malaise, neuralgia at the dermatan. The RN reported that "at this time the patient is recovering". Additional information has been requested. Y N 10/07/1998 10/14/1998 7 DNA - inadequate UNK UNK Otitis media WAES00090024 1
0171688 06/01/2001 WI 1.6 1 .0 F 05/15/2001 On 08/07/2000, the patient developed a mild case of chickenpox. It was unknown if the patient had a fever or if exposure to wild type virus occurred. The patient sought unspecified medical attention. A varicella titer was drawn 08/30/2000 and the patient was not immune or indeterminate. No further information was provided. Y U 01/11/2000 08/07/2000 209 serum varicella zoster - not immune or indeterminate PVT PVT UNK Varicella WAES00090066 1
0171689 06/01/2001 MN 18.0 F 05/15/2001 Post vax, the patient developed redness at the injection site. The patient sought unspecified medical attention. Follow up information from the health care facility indicated that the patient received another shot with no problems. It was reported that the reporter "didn't remember the name of the patient". No further information is expected. Y U OTH OTH UNK UNK WAES00090075 1
0171690 06/01/2001 MN 1.0 1 .0 F 05/15/2001 On 09/02/2000, the patient developed a fever of greater than 102F and on 09/04/2000, developed a rash consistent with varicella on her trunk, limbs, and face. Unspecified medical attention was sought. On 09/11/2000, the patient recovered. Y Y 08/28/2000 09/02/2000 5 UNK UNK UNK UNK WAES00090284 1
0171691 06/01/2001 MN 6.0 F 05/15/2001 On 08/16/2000 the patient experienced a mild case of varicella on the trunk, back, face, legs and arms. The maximum temperature was 100.0F. The patient complained of hip pain on 08/16/2000. Medical attention was sought. On 08/23/2000 the patient recovered. No further information is available. Y Y 08/15/2000 08/16/2000 1 PVT PVT Ritalin Eczema WAES00090392 1
0171692 06/01/2001 LA 2.0 2 .1 M 05/15/2001 Information has been received that indicated the patient developed varicella lesions beginning with a few and increasing to 25. On 09/01/2000 the patient developed a rash on his right arm. Over the next several days, the rash continued to develop and spread. On 09/04/2000, the patient was seen by a physician who reported that the patient had vesicular and scabbed lesions on his face, scalp, inside his mouth and throat including 1 lesion on his left anterior tonsil, right arm, trunk, and penis. The patient's fever was reported to be as high as 104F on approximately 09/03/2000. The patient has no other signs or symptoms. The physician indicated that the patient's mother and brother have both been recently diagnosed with hepatitis A. The patient was also currently in the process of being evaluated for hepatitis A with test results pending. Subsequently, the patient recovered. Additional information has been requested. Y Y 08/08/2000 08/31/2000 23 DNA - crusted lesion + for OKA vaccine strain VZV; DNA - pharyngeal lesion - negative for VZV; serum hepatitis A - + hepatitis A PVT PVT NONE Hepatitis A WAES00090422 1
0171693 06/01/2001 GA 2.0 2 .2 F 05/15/2001 On 09/02/2000 the patient experienced chickenpox. The patient experienced 4 crusted lesions on a macular base under the right arm. At the time of the report, there were 5 new macular lesions forming a rash on the trunk and legs. There were 2 on the trunk and 3 on the right leg. There was no itching. The patient was seen by a physician on 09/06/2000. The physician later reported that no side or adverse events had occurred and that the patient had recovered without problems. No further information is expected. Y Y 07/13/2000 09/02/2000 51 PVT OTH UNK UNK WAES00090423 1
0171694 06/01/2001 PA 3.0 1 .0 M 05/15/2001 On 09/02/2000 the patient developed shingles on the right arm with severe pain, 7 on a scale of 1-10. The patient's entire right arm was covered with red and painful pox. It was also reported that the patient was afebrile. A sibling had an unusual rash 2 weeks prior to this occurrence. It was noted that the varicella zoster was confirmed by a visit to the dermatologist. Additional information has been requested. Y U 10/27/1997 09/02/2000 1041 OTH OTH UNK NONE WAES00090483 1
0171695 06/01/2001 MI U 05/15/2001 Information has been received from a RN concerning 3 siblings who were vaccinated with varicella virus vaccine live. Two months later, they each experienced "25 fluid-filled lesions". Unspecified medical attention was sought. Y U OTH OTH UNK UNK WAES00090617 1
0171696 06/01/2001 IA 34.0 F 05/15/2001 Post vax, the patient developed a fever, rash, and a large, painful cold/cankor sore on her chin. Additional information has been requested. U OTH OTH UNK UNK WAES00090622 1
0171697 06/01/2001 AZ F 05/15/2001 On 09/05/2000, the patient developed a fever and on 09/07/2000 the patient developed a rash. On 09/08/2000, the patient presented to a physician with 17 lesions on her trunk, back, neck and groin. Additional information has been requested. Y U 09/01/2000 09/05/2000 4 OTH OTH UNK UNK WAES00090658 1
0171698 06/01/2001 FL 7 F 05/15/2001 Information has been received from the mother of a female child who on 07/25/2000 was vaccinated with one dose of varicella virus vaccine live. Subsequently, the patient experienced a light case of chickenpox with 100 lesions or a severe case of chickenpox (one sibling developed a severe case, and one developed a light case, the reporter did not specify which sibling developed which case.) The patient had been exposed to varicella approximately 24 months after vaccination with no problem. The patient's sibling had a similar reaction following vaccination with varicella virus vaccine live. U 07/25/2000 OTH OTH UNK Varicella exposure ~Varicella (Varivax)~1~0.00~In Sibling WAES00090689 1
0171699 06/01/2001 MI 4.0 1 .1 F 05/15/2001 In the summer of 2000, the patient developed a mild breakthrough case of chickenpox. The patient sought unspecified medical attention. Follow up information received from the RN indicated that the patient's unimmunized 2 year old sister had a "heavy" case of chickenpox in June of 2000 and the patient came down with a "mild" case of chickenpox after that. It was reported that the patient subsequently recovered. No further information is expected. Y Y 10/16/1997 08/01/2000 1020 PUB PUB varicella exposure WAES00090741 1
0171700 06/01/2001 MI 35.0 F 05/15/2001 The patient was vaccinated on approximately 08/28/2000. Subsequently in September of 2000, the patient developed 6 lesions on her chest and abdomen. The patient sought unspecified medical attention. Additional information has been requested. Y U 08/28/2000 09/01/2000 4 OTH OTH UNK UNK WAES00090759 1
0171701 06/01/2001 MI F 05/15/2001 Information has been received from a RN concerning a female who on an unspecified date was vaccinated with the second dose of varicella virus vaccine live. Subsequently, a commercially available test indicated that the patient had failed to convert. The patient sought unspecified medical attention. Additional information has been requested. Y U serum varicella zoster - negative convert OTH OTH UNK UNK WAES00090891 1
0171702 06/01/2001 MD 24.0 F 05/15/2001 On approximately 09/12/2000, the patient developed 2 lesions at the injection site and one on her back. Unspecified medical attention was sought. Additional information has been requested. Y U 08/29/2000 09/12/2000 14 OTH OTH UNK UNK WAES00090925 1
0171703 06/01/2001 NY U 05/15/2001 The patient was vaccinated on an unspecified date. On approximately 08/12/2000, the patient developed a full-blown case of chickenpox. The patient sought unspecified medical attention. Additional information has been requested. Y U 08/12/2000 OTH OTH UNK UNK WAES00090928 1
0171704 06/01/2001 NJ F 05/15/2001 In March 2000, the patient experienced a bad case of chickenpox. Soon after, the patient experienced osteomyelitis. Medical attention was sought. Y U 08/09/1999 03/01/2000 205 OTH OTH UNK UNK WAES00090930 1
0171705 06/01/2001 NC 1.2 1 .2 M 05/15/2002 The same day of the vaccination, the patient developed a "temperature". On 08/15/1999, the patient developed a "red rash and big bumps, bigger than pox, on his head and hairline, and on his legs". The patient's physician informed the patient's mother that he had a virus and it would work its way out." The patient was treated with a cream. The symptoms would go away and then reappear. The bumps were itchy. The patient was diagnosed by a dermatologist as having psoriasis, and advised it could last 6 months. "Now the patient just get lumps, not the rash, on his arms, his legs and back, The lumps start as a red mark and by the end of the day,a head with liquid forms and the next day its gets bigger sometimes of a dime. Follow up information indicated indicated that on 08/15/1999, the patient was treated with Benadryl and Aveeno. On 08/16/1999 the patient was treated with Motrin and Tylenol, tepid baths, and fluids. On 08/18/1999 the patient was seen by a physician who stated the patient had a viral illness and exanthema. The physical exam was normal, however large red tonsils were noted. On 09/26/99, the patient was noted to have a bump the size of a quarter on the leg for three days, the mother of the patient was instructed to cover it with a bandage. On 10/08/99, the patient developed "matted eyes, runny nose and cough". It was reported on 10/21/99 that the patient had an allergy to MMR. On 10/21/99, the patient had projectile vomiting, one loose stool, fever of 100.9F, irritable and was pulling at his ears. He was noted to have right otitis media and parapsoriasis. The patient was treated with Amoxil. On 11/05/99, the OM resolved. On 01/23/00, the patient was treated with Robitussin, half a treaspoon every 6 hours, for a fever and a moist cough that has persisted for 2 days and a runny nose that has persisted for 2 days. On 01/27/00, it was indicated that the patient was still experiencing a runny nose and cough. The patient was taking Atarax at this time. On 05/07/00 the patient was experiencing a decreased appetite, screaming and was fussy. It was reported that the patient "seems to quiet down when pressure is applied to his ears". On 05/07/2000, the patient was diagnosed with parapsoriasis, "now he has little bumps all over his body and is crying for no reason" and is thought to have pharyngitis. Additional information from medical records noted that on 01/25/01 , the patient had a temperature of 100 deg F, earache, cough, runny/stuffy nose described as "dark green" drainage), and a sore throat.The patient was given Amoxil. On 03/13/01, the patient's parents requested antibiotic therapy after their child developed fussiness, pulling at ears, sensitive to noise, decreased sleep, and runny nose. It was the impression that he had a left OM. The patient also had a red left typhanic membrane. The patient was given Amoxil On 03/24/01,the child was taking Advil and he had a rectal temperature of 98.5 Deg F. The patient's ears were reported to be normal and clear and how his OM had resolved. It was recommended that he continue on Augmentin for five more more days. Additional information has been requested. Y Y 08/06/1999 08/06/1999 0 Physical examination-10/21/99-abnormal-nose, congestion, Physical examination-10/21/99-abnormal-heart: 1/6 systolic with high pitched? related to fever; Physical examination-10/21/99-abnormal-skin, papulae; Physical examination-10/21/99-throat, neck, eyes and lungs; Physical examination-08/06/99 - normal; physical examination-11/05/99-abnormal-skin: papules; Physical examination-05/07/00-normal-except for throat; Physical Examination-03/24/01- normal- eyes-clear; Physical examination-11/05/99- normal - except for throat, large red tonsils were noted; Physical examination-08/18/99-norma-except for the throat/neck, large red tonsild were noted; Physical examination-03/13/01- Normal except for the tympanic membrane red; Hemoglobin-08/06/99-11.9%; Body heigh measurement-08/06/99 - 31 inches; Body temp.-01/25/01 - 100 deg F; B0ody weight measurement-08/06/99 - 22 lbs; Body weight measurement- 08/18/99 - 22 pounds, 4 oz; Body weight measurement-05/07/00 - 25 Lbs, 8 oz; WBC count-08/06/99-6.6; Temperature measurement - 10/??/99-103.6 deg F; Rectal Temp. - 08/16/99-103 deg F; Rectal Temp -08/16/99 - 101.6 - morning; Rectal temp. - 03/24/01-98.5 Deg F;Rectal temp. - 100 deg F; Rectal temp -05.0/00 - 99 deg F; Rectal temp.-10/21/99-100.9; Rectal temp.-08/18/99 -101.5 deg F; Body weigh measurement-01/27/00- 24 lbs; Body weight measurement-10/21/99-22 lbs, 9 oz; Body weight measurement-08/15/99-22; Body weight measurement-03/24/01- 29 lbs, Body weight measurement-01/25/01 - 30 Lbs; Body weight measurement-03/13/01-30 lbs; Head circumference -08/06/99 -18.5 inches. OTH OTH vaccine allergy, Hypersensitivity WAES00091032 1
0171706 06/01/2001 VA M 05/15/2001 Information has been received from a health professional concerning a male child who was vaccinated with 1 dose of varicella virus vaccine live. Subsequently, the patient experienced chickenpox. His body was covered with chickenpox. Another patient was reported with a similar experience. No further information is available. U UNK UNK UNK UNK WAES00081151 1
0171707 06/01/2001 NY 2.0 U 05/15/2001 Information has been received from a RN concerning children who were vaccinated with varicella virus vaccine live. It was reported that there was an outbreak of chickenpox at a school. It was reported that a 5 year old child with epidermolysis bullosa attends the school and was exposed to the children with chicken pox, however never developed chickenpox. Unspecified medical attetion was sought. No further information is available. Y U UNK UNK UNK UNK WAES00091160 1
0171708 06/01/2001 IL 36.0 31 F 05/15/2001 On 09/12/2000 the patient developed a severe case of chicken pox that was described as a "classic" case of chickenpox. The patient had pox all over her body as well as in her throat and mouth. The patient required an ER or physician visit. On 09/20/2000 te patient recovered. No further information was provided. Y Y 08/13/1996 09/12/2000 1491 PVT PVT NONE NONE WAES00091277 1
0171709 06/01/2001 NE 1.9 1 .0 M 05/15/2001 On 09/10/2000 the patient's mother reported that the patient developed red dots generalized over his body. Within 24 hours she reported that they looked "blistery like chickenpox". Over the next 2 days he continued to break out and follow a chickenpox pattern but by day 4 they were not scabbing and drying like pox. The patient was seen by the physician. It was reported that the physician felt it was "dermatitis with impetiginous changes rather than pox". The physician determined that this was not a breakthrough case. On 09/18/2001 the patient recovered. No further information is available. Y Y 11/02/1999 09/10/2000 313 UNK UNK UNK UNK WAES00091302 1
0171710 06/01/2001 MA 1.0 1 .0 F 05/15/2001 On approximately 09/15/2000, the patient experienced 2 lesions. The patient sought unspecified medical attention. No further information is available. Y U 09/13/2000 09/15/2000 2 OTH OTH UNK UNK WAES00091332 1
0171711 06/01/2001 GA M 05/15/2001 Information has been received from a pharmacist concerning a male patient with Hodgkin's disease who developed shingles following exposure to his son who was vaccinated on 08/01/2000 with one dose of varicella virus vaccine live. The reporter questioned whether the varicella virus vaccine activated the shingles in the patient and if shingles can be transmitted to someone who has not had chickenpox. Additional information has been requested. U 08/01/2000 08/01/2000 0 OTH OTH UNK Hodgkin's lymphoma WAES00091353 1
0171712 06/01/2001 MN 1.25 1 .3 M 05/15/2001 On 09/16/2000 the patient experienced a fever greater than 102F. On 09/18/2000 the patient developed chickenpox (macropapular rash) on his face, trunk, limbs, and groin. Unspecified medical attention was sought. The nurse reported that the patient "has no postulates on his face or trunk; it is not seeping". The patient had not yet recovered at the time of the report. Additional information has been requested. Y N 09/07/2000 09/16/2000 9 PVT PVT UNK WAES00091447 1
0171713 06/01/2001 WA 16.0 M 05/15/2001 On 09/13/2000 the patient developed 15 lesions with a fever of 103F. The patient sought unspecified medical attention. Additional information has been requested. Y U 08/28/2000 09/13/2000 16 OTH OTH UNK UNK WAES00091459 1
0171714 06/01/2001 NY 25.0 F 05/15/2001 Information has been received from a physician concerning a patient who was vaccinated with a first and second dose of varicella virus vaccine live. Subsequently, the serum varicella virus antibody test indicated that titers done were undetectable. Unspecified medical attention was sought. Additional information has been requested. Y U Serum varicella zoster - titers done which were undetectable OTH OTH UNK UNK WAES00091460 1
0171715 06/01/2001 GA 1.7 1 .0 M 05/15/2001 On 09/14/2000 the patient developed a mild case of chickenpox which consisted of greater than 50 varicella lesions and a fever of 100.7 axillary. Subsequently, the patient recovered. Additional information is not expected. Y Y 01/10/2000 09/14/2000 248 PVT PVT Sulfa Allergy WAES00091468 1
0171716 06/01/2001 CO 8.0 F 05/15/2001 Three days post vaccination, the patient developed "chickenpox with 75 to 100 lesions". The patient sought unspecified medical attention. Additional information has been requested. Y U OTH OTH UNK UNK WAES00091479 1
0171717 06/01/2001 TX U 05/15/2001 Information has been received from a physician concerning a patient who was vaccinated with a does of varicella virus vaccine live. Subsequently, on approximately 09/18/2000, the patient developed a breakthrough rash. It was reported that the grandmother, who is the baby-sitter, was on chemotherapy. Additional information has been requested. Y U 09/18/2000 OTH OTH UNK UNK WAES00091532 1
0171718 06/01/2001 IL 20.0 F 05/15/2001 Three hours post vaccination, the patient experienced generalized spots, fever and itching. Medical attention was sought. No further information is available. Y U 09/17/2000 09/17/2000 0 UNK UNK UNK UNK WAES00091609 1
0171719 06/01/2001 KS U 05/15/2001 Information has been received from a health professional concerning an unidentified patient who was vaccinated with a first and second dose of varicella virus vaccine live and did not seroconvert. On 08/03/2000 the patient was vaccinated with a 3rd dose of varicella virus vaccine live. The patient was treated with Depo-Medrol. Unspecified medical attention was sought. Additional information has been requested.- Y U 08/03/2000 Serum varicella zoster - did not seroconvert OTH OTH Depo-Medrol UNK WAES00091611 1
0171720 06/01/2001 TX M 05/15/2001 On 09/07/2000 the patient developed herpes zoster. Unspecified medical attention was sought. It was noted that it is unknown whether exposure occurred. As of 09/19/2000 the patient was afebrile. Additional information has been requested. Y U 07/27/2000 09/07/2000 42 OTH OTH UNK UNK WAES00091819 1
0171721 06/01/2001 NY 1.25 1 .3 F 05/15/2001 On 09/15/2000, 3 days post vaccination, the patient's mother reported that the patient had developed a mild case of "chicken pox" outbreak to her neck, face and diaper area and a fever of 102.5F. It was noted that this was a "greater than mild case of chicken pox". Medical attention was sought. Subsequently, the patient recovered. No further information was available. Y Y 09/12/2000 09/15/2000 3 NONE OTH OTH Condition unspecified WAES00091711 1
0171722 06/01/2001 TX 25.0 F 05/15/2001 The patient was vaccinated with the first does of varicella virus vaccine live on 09/18/2000. Subsequently, the patient experienced slight redness. The redness was resolved in 2 days. The patient experienced redness and tenderness after the second dose of vaccine. There was no resolution after 48 hours. Medical attention was sought. No further information is available. Y U 09/18/2000 09/18/2000 0 OTH OTH UNK UNK WAES00091716 1
0171723 06/01/2001 NJ 31.0 31 F 05/15/2001 On 09/15/2000 at 4:45 PM, the patient developed a local rash at the injection site. It was reported to be 3 little bumps at the site of injection and was reported to be itchy. Subsequently, the patient recovered. On 11/03/2000 the patient was vaccinated SC in the left arm at 8:40 am with the second dose of varicella virus vaccine live and it was reported that the patient experienced an injection site reaction. On 11/05/2000 the patient experienced redness and swelling with a hard lump at the site. It was reported that the redness and edema radiates down the arm. The patient sought unspecified medical attention. On follow up it was reported that the patient was treated with Valtrex. Subsequently, the patient recovered 11/04/2000. No further information is expected. Y Y 09/05/2000 09/15/2000 10 PVT PVT UNK NONE WAES00091725 1
0171724 06/01/2001 FL 34.0 34 F 05/15/2001 The patient was vaccinated in March and April 2000 with a first and second dose of varicella virus vaccine live. In August 2000, the patient sought unspecified medial attention and was found to be seronegative. Additional information has been requeste.d Y U 04/01/2000 08/01/2000 122 serum varicella zoster - sero negative OTH OTH UNK UNK WAES00091739 1
0171725 06/01/2001 NH 5.0 1 .3 F 05/15/2001 On 09/20/2000, the patient was diagnosed with chickenpox. There were greater than 12 spots and no fever. It was noted that the patient's mother had shingles. Follow up information from a physician indicated that subsequently the patient recovered. Y Y 01/06/1997 09/20/2000 1353 PVT PUB NONE Herpes zoster exposure WAES00091740 1
0171726 06/01/2001 FL 2.0 1 .0 M 05/15/2001 On 09/05/2000, the patient developed chickenpox. Follow up information from a physician indicated that on 09/15/2000 the patient fully recovered. Y 07/29/1999 09/05/2000 404 PVT PVT UNK UNK WAES00091815 1
0171727 06/01/2001 MA 7.0 M 05/15/2001 On 09/21/2000 the patient experienced generalized rash. The patient does not have a fever. Medical attention was sought. Y U 08/24/2000 09/21/2000 28 UNK UNK UNK UNK WAES00091848 1
0171728 06/01/2001 AZ 46.0 45 F 05/15/2001 In January 2000, the patient was vaccinated with varicella virus vaccine live. In June 2000, the patient received the polio vaccine and the tetanus toxoid and a week later experienced paresthesia, which is still ongoing. A MRI was negative for MS. Medical attention was sought. No further information is available. Y N 01/01/2000 06/01/2000 152 MRI - negative for MS OTH OTH NONE Asthma, migraine WAES00091876 1
0171729 06/01/2001 CA 1.0 1 .0 F 05/15/2001 On 09/18/2000 the patient presented to a physician's office with a varicella-like rash after exposure to wild-type virus at her daycare. The physician reported the patient presented with a cluster of vesicular lesions on her neck that did not have a dermatomal distribution. They appeared like classic varicella lesions. The physician indicated that he believed "this probably represents partial failure of the immunization". Additional information has been requested. Y U 04/24/1998 09/18/2000 878 OTH OTH UNK Varicella exposure WAES00091879 1
0171730 06/01/2001 CO 5.0 6 F 05/15/2001 In the summer of 1998, the patient developed a mild case of chickenpox. On 09/19/2000, the patient "broke out in chickenpox again" that was described as a red, itchy rash with approximately 20-25 lesions on head and trunk of body. The patient sought unspecified medical attention. In follow up the patient's physician's office reported that they were unaware of any adverse events related to varicella virus vaccine live. It was noted that there were no telephone messages or office visits related to adverse events. Y U 04/27/1999 UNK UNK Septra otitis media UNK WAES00081882 1
0171731 06/01/2001 WA 1.08 1 .1 M 05/15/2001 On 09/17/2000 the patient was seen in a clinic with truncal ataxia. The patient appeared to be a little fussy but was afebrile and had no rash. The physician stated that the child had been a good walker previously but currently had what she described as acute cerebellar ataxia. Follow up information received 11/06/2000 from a physician stated that she felt that the ataxia was secondary to vaccination with varicella virus vaccine live. The physician stated that the child has made a full recovery. The patient's mother noted that the right leg seemed to "give way at times". It was noted there was no trauma. The diagnosis was right lower extremity pain and difficulty in walking. The patient was treated with Tylenol or Motrin. No further information is available. Y Y 09/13/2000 09/17/2000 4 lymph - atypical; mono - 13; anion gap - 6mmol; plasma alkaline - 355U/L; serum BUN/creatinine - 25; total serum protein - 6.0; serum creatine - .4mg/dl; plasma aspartate - 42 U/L; mean corpuscular - 36.2g/dl; erythrocyte - 2 mm/hr; segmented neutrophil - 17; PVT OTH Gastroesophageal reflux disease Head trauma, male circumcision, sickle cell trait WAES00091917 1
0171732 06/01/2001 FL 1.6 1 .6 M 05/15/2001 Within 30 minutes of vaccination, the patient developed a fever and a whole body urticarial rash without respiratory distress. Medical attention was sought. The patient's symptoms resolved following treatment with Benadryl but for persistent left arm swelling. Within 24 hours of vaccination, the patient's symptoms were resolved. No further information is available. Y Y 09/20/2000 09/20/2000 0 NONE UNK UNK Upper respiratory infection UNK WAES00091922 1
0171733 06/01/2001 MI 1.0 1 .0 F 05/15/2001 On 09/22/2000, the patient developed a varicella like rash on the chest and neck. The nurse was unsure of the number of lesions and no fever was reported. Unspecified medical attention was sought. In follow up, the LPN reported that the patient had recovered. No further information is available. Y Y 09/11/2000 09/22/2000 11 NONE PVT PVT NONE WAES00082006 1
0171734 06/01/2001 IN 4.0 4 F 05/15/2001 On 09/15/2000 the patient experienced chickenpox with about 70 lesions and no fever. Medical attention was sought. It was felt that the patient had a "light case" and she recovered. No further information is available. Y Y 04/05/2000 09/15/2000 163 UNK UNK UNK UNK WAES00082014 1
0171735 06/01/2001 MI 4.0 1 .0 F 05/15/2001 On 09/05/2000 the patient developed mild red areas and central vesicles on her abdomen, back and groin. On 09/20/2000 the patient recovered from her symptoms. Additional information is not expected. Y 11/13/1996 09/05/2000 1392 UNK UNK UNK UNK WAES00092044 1
0171736 06/01/2001 UT 3.0 1 .0 F 05/15/2001 On 06/05/2000 the patient developed shingles on the left side of her face and an infection. On 06/16/2000 the patient experienced folliculitis. On 06/16/2000 the patient recovered. Y 09/29/1997 06/05/2000 980 PVT PVT Bronchitis, upper respiratory infection UNK WAES00092055 1
0171737 06/01/2001 PA 7.0 4 M 05/15/2001 On 09/15/2000, the patient presented with chickenpox that consisted of greater than 50 lesions. Unspecified medical attention was sought. Additional information has been requested. Y U 03/11/1997 09/15/2000 1284 OTH OTH UNK UNK WAES00092082 1
0171738 06/01/2001 MD 6.0 2 .0 M 05/15/2001 On 09/25/2000 the patient presented with chickenpox that consisted of greater than 50 lesions and no fever. It was indicated that other unspecified patients had similar adverse experiences with the same lot of vaccine, therefore the reporter stated a concern about the lot. Additional information has been requested. Y U 07/09/1996 09/25/2000 1539 OTH OTH UNK UNK WAES00092099 1
0171739 06/01/2001 OH 4.0 1 .6 M 05/15/2001 On 09/24/2000 the patient developed an unknown number of pox. It was noted that it was a mild case and the patient was afebrile. Unspecified medical attention was sought and the patient was diagnosed with atypical varicella. Follow up information from the RN indicated that the patient had multiple lesions and broke out for 10 days. Subsequently on 10/04/2000, the patient recovered. No further information is available. Y Y 02/26/1998 09/24/2000 941 PVT PVT NONE NONE WAES00092114 1
0171740 06/01/2001 NC 9.0 4 M 05/15/2001 The patient was vaccinated 09/07/1995. It was noted that the patient has a history of recent varicella exposure from his sister 10 days prior. On 09/12/2000 the patient complained of a sore on the right buttock which was the size of a nickel and looked like a popped blister. It was reported the patient developed a few more blisters looking more like zoster in the local area over the next few days. All the lesions were localized to the buttock and were sore to the touch. Unspecified medical attention was sought and the patient received 10-14 days total treatment. The patient's sister experienced a reaction following exposure to varicella virus vaccine live. Additionally, it was noted that the physician felt that the results were "interesting" since the two siblings had broken out within 2 weeks of each other. He stated that he "guessed it could have been a herpes simplex". Follow up information from a physician indicated that there was 1 6 x 4 inch area of papules and vesicles which was located on the right gluteal region. The patient's pain was noted to be 1 on a 1-10 scale. There were no other systemic symptoms and the patient was afebrile. Additionally, it was noted that a rash did not occur at the site of the injection or elsewhere within 42 days of the vaccination. The patient was treated acyclovir and recovered 09/20/2000. No further information is available. Y Y 09/07/1995 09/12/2000 1832 Tzank prep test - positive; DNA - VZV negative PVT PVT NONE Varicella exposure rash~Varicella (Varivax)~~16.00~In Patient|~Varicella (Varivax)~~16.00~In Sibling WAES00092186 1
0171741 06/01/2001 OH 1.0 1 .0 F 05/15/2001 On 09/13/2000 the patient experienced a fever of 102F. On 09/13/2000 the patient experienced chicken pox with red vesicles on the abdomen and right leg. On 09/15/2000 the patient was diagnosed with chicken pox. On 09/18/2000 the patient developed a macular papular rash on her trunk and uniformly over her entire body. It was accompanied by fevers of up to 104F. The patient was diagnosed with viral exanthema. Medical attention was sought. The patient recovered as of 09/27/2000. No further information is available. Y Y 09/08/2000 09/13/2000 5 PVT PVT UNK WAES00092204 1
0171742 06/01/2001 MI 3.0 0 .8 F 05/15/2001 On 09/20/2000 the patient developed varicella. It was noted that she was febrile and had pox on her left leg, trunk and right arm. Prescription drug treatment was not required for the patient's experience. Subsequently, the patient recovered. No further information is available. Y 06/19/1998 09/20/2000 824 PVT OTH NONE UNK WAES00092211 1
0171743 06/01/2001 IL F 05/15/2001 Information has been received from a physician concerning a female who in 1995 was vaccinated with varicella virus vaccine live. Subsequently, the patient experienced a lack of response. No further information is available. U serum varicella zoster - negative UNK UNK UNK UNK WAES00092268 1
0171744 06/01/2001 TX 6.0 2 .0 F 05/15/2001 On approximately 09/27/2000, the patient developed a "light case of chickenpox with no fever". Unspecified medical attention was sought. Additional information has been requested. Y U 08/20/1996 09/27/2000 1499 PVT PVT UNK UNK WAES00092343 1
0171745 06/01/2001 NY U 05/15/2001 Information has been received concerning an adult patient who was vaccinated with 2 doses of varicella virus vaccine live. The patient sought medical attention and failed to seroconvert. Additional information has been requested. Y U serum varicella zoster - negative after 2 doses OTH OTH UNK UNK WAES00092365 1
0171746 06/01/2001 PA 4.0 1 .0 F 05/15/2001 On approximately 09/28/2000, the patient developed a varicella like rash and a low grade fever. It was reported by the patient's father that she had more than 100 lesions. The patient sought unspecified medical attention. Follow up information received from the physician's office indicated that this is not one of their patients. No further information is available. Y U 03/31/1997 09/28/2000 1277 OTH OTH NONE UNK WAES00092457 1
0171747 06/01/2001 CA 1.3 1 .3 M 05/15/2001 On 09/10/2000 the patient developed a papular rash which became vesicles, the crusts. It was noted that the patient had approximately 50 lesions in total on the trunk and extremities. It was also reported that the patient developed impetigo and was treated with Keflex. On 09/25/2000 the patient recovered. Additional information is not expected. Y Y 08/21/2000 09/10/2000 20 NONE OTH PUB NONE WAES00092540 1
0171748 06/01/2001 MA 1.0 M 05/15/2001 One day post vax, the patient experienced a rash at the site of the injection. He also experienced a rash on the abdomen. Medical attention was sought. No further information could be obtained from the health professional because a patient name was not supplied. Y U OTH OTH NONE UNK WAES00092552 1
0171749 06/01/2001 PA 5.0 M 05/15/2001 In 1998 the patient was vaccinated with 1 dose of varicella virus vaccine live. In the year 2000, the patient experienced chickenpox. The patient was covered with chickenpox. The patient's brother had a similar experience following vaccination with varicella virus vaccine live. Medical attention was sought. No further information is available. Y U UNK UNK UNK UNK ~Varicella (Varivax)~~7.00~In Sibling WAES00100037 1
0171750 06/01/2001 NC 16.0 F 05/15/2001 In 1986 the patient was vaccinated with 1 dose of varicella virus vaccine live. It was reported that "over 2 weeks there was a gradual onset beginning of an eczematous rash with a few blisters that broke easily and dried quickly. The patient was seen by a physician and treated with acyclovir after 10 days and resolved fairly rapidly over the week. The patient also developed a blister on her other cheek. Additionally, a burning feeling and occasional itching were noted. The patient's brother experienced a reaction following exposure to varicella vaccine live. No further information is available. Y Y OTH OTH UNK UNK ~Varicella (Varivax)~~9.00~In Sibling WAES00100084 1
0171751 06/01/2001 MI 3.0 1 .9 F 05/15/2001 On 08/31/2000 the patient experienced chicken pox with less than 30 lesions and no fever or other symptoms of illness. The mother is unaware if the patient was exposed to wild type virus. Medical attention was sought. The patient recovered. No further information is available. Y Y 10/26/1998 08/31/2000 675 PUB PUB NONE UNK WAES00100125 1
0171752 06/01/2001 MI 2.0 1 .0 F 05/15/2001 On 08/26/2000 the patient experienced fever and irritability. On 08/28/2000 the patient developed about 50 chicken pox lesions. Medical attention was sought. In follow up information received from the nurse, the patient was seen on 09/06/2000 for WIC clinic. The reported noted that the lesions were crusting and the patient's experience had resolved. Y Y 10/26/1998 08/26/2000 670 PUB PUB NONE NONE WAES00100127 1
0171753 06/01/2001 CA 3.0 1 .0 F 05/15/2001 On 10/01/2000 the patient developed 10-15 herpes zoster vesicles on her right hand. On 10/02/2000 the patient was seen in the physician's office. The vesicles were located on the patient's right side. There were 7 to 8 grouped vesicles over an erythematous base. The patient's maximum temperature was 97.9F. Pain was noted to be 4 on a 1-10 scale with itching. Additionally it was noted that the rash did not occur at the site of injection or elsewhere within 42 days of vaccination. A specimen was obtained for PCR analysis on 10/02/2000 and the results are pending. The patient's herpes zoster persisted. Follow up information indicated that the preliminary PCR was VZV positive. Final results are pending. Follow up information indicated that the final PCR result was positive for wild-type VZV. Additional information has been requested. Y N 04/20/1998 10/01/2000 895 DNA - positive for wild type VZV OTH OTH NONE UNK WAES00100150 1
0171792 06/01/2001 MI 7.0 2 .8 M 05/15/2001 On 10/06/1995 the patient was vaccinated with a second dose of varicella virus vaccine live. Subsequently, the patient developed "typical chickenpox". Unspecified medical attention was sought. Additional information has been requested. Y U 10/06/1995 OTH OTH UNK UNK WAES00100193 1
0171793 06/01/2001 PA 30.0 30 F 05/15/2001 On 07/26/2000 and on 08/16/2000 the patient was vaccinated with a first and second dose of varicella virus vaccine live, respectively. It was reported that the patient was tested in the physician's office and was found to have a negative varicella antibody prior to and after the second dose of varicella virus vaccine live. Additional information has been requested. Y U 08/16/2000 09/01/2001 381 Serum varicella zoster - negative titer OTH OTH Allegra-D, hormonal contraceptives Seasonal allergy WAES00100253 1
0171794 06/01/2001 OH 2.0 1 .0 F 05/15/2001 On 10/03/2000, it was reported the patient "presented with no fever and 15 chickenpox lesions". Initially it had been reported that the patient sought medical attention, however follow up information indicated that the patient's experience did not require a doctor visit. The outcome of the patient's experience was not reported. No additional information is expected. U 01/28/1999 10/03/2000 614 PVT PVT UNK UNK WAES00100261 1
0171795 06/01/2001 CA 7.0 U 05/15/2001 The patient was vaccinated at 18 months of age. Subsequently, at 7 years of age, the patient developed varicella with more than 100 lesions. The patient sought unspecified medical attention. Also reported were other patients who were vaccinated and experienced similar events. Additional information has been requested. Y U OTH OTH UNK UNK WAES00100359 1
0171796 06/01/2001 KY 2.0 1 .0 F 05/15/2001 Information has been received from a registered nurse concerning a 19 month old female patient with a runny nose and congestion at the time of vaccination who on 4/19/99 was vaccinated with a first dose of varicella virus vaccine live SC in the right arm. Concomitant vaccinations that same day included a first dosae of MMR virus vaccine live SC in the left arm and tuberculin Y Y 04/19/1999 10/02/2000 532 PVT PVT Tuberculin purified protein derivative Runny nose and congestion UNK WAES00100360 1
0171797 06/01/2001 PA 7.0 M 05/15/2001 The patient was vaccinated with 1 dose of varicella virus vaccine live in 1998. In approximately September 2000, the patient experienced chickenpox. He was covered with chickenpox. The patient's brother had a similar experience following vaccination with varicella virus vaccine live. Medical attention was sought. No further information is available. Y U UNK UNK UNK UNK ~Varicella (Varivax)~1~5.00~In Sibling WAES00100398 1
0171798 06/01/2001 MA 27.0 27 F 05/15/2001 On 09/30/2000, the patient developed a "swollen gland on the side of her neck, followed 2 days later with a single eruption and itching of her forearm. In the next 2 to 3 days, 7 additional eruptions appeared on her upper body. The patient was seen by a nurse on 10/04/2000. The lesions are dry with scab formation and erythema of areas. There were less than 10 lesions total. It was noted that on 09/06/2000 the patient was administered a Tb booster with a negative result. No further information is expected. Y U 09/15/2000 09/30/2000 15 tuberculin skin test - negative OTH OTH Hormonal contraceptives Allergy WAES00100424 1
0171799 06/01/2001 10.0 M 05/15/2001 The patient was vaccinated in approximately 1995. Subsequently in approximately October 2000, the patient experienced a mild rash. It was reported the rash was on his back, chest, abdomen, and genitalia. Unspecified medical attention was sought. It was reported that the patient's sister had a similar experience following exposure to varicella virus vaccine live. Additional information has been requested. Y U 10/01/2000 OTH OTH UNK UNK ~Varicella (Varivax)~1~8.00~In Sibling WAES00100439 1
0171800 06/01/2001 VA U 05/15/2001 On 10/02/2000 the patient presented with an outbreak of 34 pox. Unspecified medical attention was sought. Follow up information from a RN indicated that she did not consider the patient's experience an adverse experience. Y U 09/11/2000 10/02/2000 21 OTH OTH UNK UNK WAES00100442 1
0171801 06/01/2001 GA 3.0 1 .2 F 05/15/2001 On 10/02/2000 the patient experienced chickenpox. The patient had only a few red lesions on her chest and stomach. The patient had no fever. Unspecified medical attention was sought. Follow up information indicated the patient recovered. No further details were provided. Y Y 02/23/1998 10/02/2000 952 UNK UNK UNK UNK WAES00100587 1
0171802 06/01/2001 CA U 05/15/2001 Information has been received from a LVN concerning 8 children from different families who on unspecified dates were vaccinated with one dose of varicella virus vaccine live. Subsequently, the children developed varicella with a large number of lesions of 100 or more for each child. The children sought unspecified medical attention. Also reported were other patients who were vaccinated and experienced similar events. Additional information has been requested. Y U OTH OTH UNK UNK WAES00100643 1
0171803 06/01/2001 CA U 05/15/2001 Information has been received form a LVN concerning "other patients" who on unspecified dates were vaccinated with one dose of varicella virus vaccine live. Subsequently, the patients developed breakthrough varicella years after vaccination. The patients sought unspecified medical attention. Also reported were other patients who experienced similar events. Additional information has been requested. Y U OTH OTH UNK UNK WAES00100644 1
0171804 06/01/2001 CA U 05/15/2001 The patient was vaccinated on an unspecified date. "Years" post vax, the patient experienced a low titer. The patient sought unspecified medical attention. Also reported were patients who were vaccinated and experienced similar events. Additional information has been requested. Y U serum varicella zoster - low titer OTH OTH UNK UNK WAES00100645 1
0171805 06/01/2001 SC 1.0 1 .0 M 05/15/2001 On approximately 10/01/2000 the patient experienced "breakthrough lesions on his trunk, neck and arms". He was seen in a physician's office on 10/07/2000. Follow up information reported that the patient was diagnosed with "probable Varivax reaction, candical diaper dermatitis". It was noted the patient had a few pink papules on his trunk and 2 fluid filled. Additionally the injections site was red and tender. The patient was seen again on 10/12/2000. It was reported that the "spots faded" and the patient recovered. No further information is available. Y Y 09/28/2000 10/01/2000 3 NONE PVT PVT Upper respiratory infection UNK WAES00100724 1
0171806 06/01/2001 DE M 05/15/2001 Information has been received from a LPN concerning a male patient whose 12 month old sone was vaccinated on 09/25/2000 with a dose of varicella virus vaccine live. It was reported that the time of his son's vaccination, the patient was being treated with Medrol dose pack for an unknown problem. The patient subsequently experienced secondary transmission. About 5 days after his son's vaccination on approximately 10/01/2000, the patient developed a fever of 102F. On 10/04/2000 the patient developed a varicella like rash over his entire body and went to the ER. The ER physician confirmed that it was chicken pox and treated the patient with acyclovir and he was released the same day. It was noted that his son attends daycare and no one there has chickenpox. The patient did not have chickenpox as a child. The nurse reported that the child has not had a rash. The plan as of 10/12/2000 was to send a specimen for PCR analysis. Additional information has been requested. Y U 10/01/2000 UNK UNK Medrol WAES00100747 1
0171807 06/01/2001 CA 1.0 F 05/15/2001 Three weeks post vaccination, the patient developed chickenpox with a fever which lasted one day. It was reported that the lesions covered her body. Unspecified medical attention was sought. Additional information has been requested. Y Y 06/02/2000 06/23/2000 21 OTH OTH UNK UNK WAES00100754 1
0171808 06/01/2001 PA 3.0 M 05/15/2001 In August 2000 (previously reported as the beginning of September 2000) the patient developed a full blown classic case of chickenpox with greater than 50 pox and "all the symptoms that go with chickenpox". It was noted that the patient was covered with varicella spots. The nurse noted it was the same course as if the patient had not received the vaccine, greater than 50 spots, one week to break out, and two weeks to scab up and recover. The patient recovered approximately August, 2000. The patient was seen in the doctor's office on 09/22/2000 and was noted to have scabbing and scarring of pox. No further information is available. Y Y 12/01/1997 PVT OTH NONE NONE 1
0171809 06/01/2001 LA 25.0 F 05/15/2001 On 10/08/2000 the patient developed lesions on her trunk, face and a couple on her arm. It was noted that there was a total of approximately 15 lesions. The patient was seen by a physician who reported that the patient presents clinically with chickenpox. Additional information has been requested. Y U 09/21/2000 10/08/2000 17 UNK UNK UNK UNK WAES00100848 1
0171810 06/01/2001 AL F 05/15/2001 Post vax, the patient experienced a local site reaction on the arm. Unspecified medical attention was sought. Additional information has been requested. Y U OTH OTH UNK UNK WAES00100653 1
0171811 06/01/2001 CO 25.0 F 05/15/2001 On approximately 10/10/2000 the patient experienced apparent chickenpox with approximately 50 lesions on her trunk. Medical attention was sought. Follow up information provided by a physician indicated that he had never seen the patient. He heard about the case from the patient's father, who contacted him by e-mail. The patient was over 1000 miles away from the physician. The patient's father described about 50 chickenpox lesions a few days after the patient received the vaccine in approximately September 2000. The physician noted that he did some research out of interest. On 12/06/2000, the physician reported that the patient's father told him the patient was "better". She never got sick and the case resolved. No further information is available. Y Y 09/27/2000 10/10/2000 13 OTH OTH UNK UNK WAES00100893 1
0171812 06/01/2001 NC 53.0 M 05/15/2001 Information has been received from a RN concerning a patient who on approximately 07/26/2000 was exposed to an individual who had developed chickenpox through secondary transmission after having been exposed on 07/10/2000 to a child, who had developed typical chicken pox spots following vaccination with varicella virus vaccine live. Approximately in late July 2000, the patient became fatigued and he experienced stinging in the lumbar region of the back. After approximately 4 days, blisters appeared at the site. On 09/19/2000, the patient was seen in the reporting physician's office. A physical exam revealed a macupapular vesicular rash around L2/L3 distribution on the right side. No weeping lesions or secondary infection were noted. Herpes Zoster was diagnosed and the patient was seen in the physician's office for a follow up visit and the herpetic lesions were well healed. Additional information is not expected. Y Y OTH OTH Varicella exposure, asthma, smoking WAES00100930 1
0171813 06/01/2001 MA 3.0 1 .0 F 05/15/2001 On 09/06/2000 the patient developed chickenpox disease. Subsequently, the patient recovered. Two additional patients has a similar experience following exposure to varicella virus vaccine live. No further information is available. Y 02/10/1998 09/06/2000 939 PVT PUB UNK NONE WAES00100931 1
0171814 06/01/2001 MA 5.0 0 .3 F 05/15/2001 On 09/14/2000 the patient developed varicella. Subsequently, the patient recovered. Two additional patients had a similar experience following exposure to varicella virus vaccine live. No further information is available. Y 04/08/1995 09/14/2000 1986 PVT PUB UNK NONE WAES00100933 1
0171815 06/01/2001 MA 4.0 4 M 05/15/2001 On 08/31/2000 the patient developed varicella with greater than 50 lesions. Subsequently, the patient recovered. Two additional patients had a similar experience following exposure to varicella virus vaccine live. No further information is available. Y 08/21/2000 08/31/2000 10 UNK UNK UNK NONE WAES00100934 1
0171816 06/01/2001 GA 6.0 F 05/15/2001 On 10/11/2000, the patient developed 3-4 varicella like lesions on her wrist and was seen in a physician's office. No other symptoms were reported. Additional information has been requested. Y U 05/18/1998 10/11/2000 877 OTH OTH UNK UNK WAES00100956 1
0171817 06/01/2001 CA 7.0 3 M 05/15/2001 On 10/09/2000 the health professional stated the patient "has varicella" with 12 lesions, 5 macular, papular and 6 crusted. Follow up information stated "pruritic fluid filled, red based lesions erupted on her face, back and groin. The patient has recovered. Y 03/27/1996 10/09/2000 1657 PVT PVT UNK UNK WAES00100995 1
0171818 06/01/2001 WI 33.0 F 05/15/2001 Information has been received on a patient who in the fall of 1997 was vaccinated with one dose of varicella virus vaccine live. In approximately October 2000, recent titers indicated that the patient had not seroconverted. The patient sought unspecified medical attention. Additional information has been requested. Y U 10/01/2000 serum varicella zoster - negative OTH OTH UNK UNK WAES00101065 1
0171819 06/01/2001 GA 3.0 2 .0 F 05/15/2001 On 10/11/2000 the patient experienced red, itchy, and blistery vesicles on her arms, legs, trunk, and face, too many to count. Unspecified medical attention was sought. No further information is available. Y U 10/13/1997 10/11/2000 1094 OTH OTH UNK UNK WAES00101089 1
0171820 06/01/2001 NY F 05/15/2001 Information has been received from a health professional concerning a patient who in 1998 was vaccinated with a first dose of varicella virus vaccine live. Subsequently, the patient sought unspecified medical attention and it was noted that she "failed to seroconvert". Additional information has been requested. Y U serum varicella zoster - failed to seroconvert OTH OTH UNK UNK WAES00101204 1
0171821 06/01/2001 OR 21.0 21 M 05/15/2001 The patient was vaccinated on 09/23/1999, one day after exposure to varicella. On day three post vax, the patient developed lesions and a fever. A small number of lesions were experienced during the next few days. On 10/04/1999 the patient was diagnosed with chicken pox lesions on his back, chest and arms. The patient required and ER visit for his symptoms. On 10/19/1999 the patient recovered from his symptoms. Additional information is not expected. Y Y 09/23/1999 09/25/1999 2 UNK UNK UNK Varicella exposure WAES00101210 1
0171822 06/01/2001 OR 32.0 F 05/15/2001 Information has been received from a RN concerning a patient who in 1999 was vaccinated with 2 doses of varicella virus vaccine live. The reporter said she thinks the recommended interval was observed. The patient failed to seroconvert on her titer test given 09/27/2000. The patient sought unspecified medical attention. Follow up information from the same RN indicated the titer was drawn on the patient, a qualitative test was done instead of a quantitative test. Hence, the most accurate results were not obtained. The nurse did not feel that an adverse event had occurred. No further details were provided. Y U 09/27/2000 serum varicella zoster - failed to seroconvert OTH OTH UNK UNK WAES00101227 1
0171823 06/01/2001 1.0 F 05/15/2001 On 10/12/2000 the patient's injection site turned into a welt and was warm to the touch. It was noted that she was afebrile and that "her doctor felt this was not uncommon. On 10/14/2000 the patient broke out in hives on either side of her chest just under her arms. It was noted that additional round hives appeared on her legs, stomach and neck. She is not covered with them. The patient sought unspecified medical attention and her physician indicated that "it was not the chickenpox". It was reported that the hives almost disappeared during the night and then reappear. During the day, new ones come and go. The patient is being treated with Benadryl. The reported noted that the hives do not appear to itch and that she remains afebrile. Additional information has been requested. F/U info was received from the physician's office on 6/17/02 which indicated that they did not know what pt was involved in this case. Additional info is not expected. Y U 10/05/2000 10/12/2000 7 OTH OTH UNK UNK WAES00101279 1
0171824 06/01/2001 OH 1.2 1 .2 F 05/15/2001 Post vax, the patient's mother reported that the patient was "more irritable after the shot". The mother reported that the child "keeps on crying". Additional information has been requested. U 10/06/2000 10/06/2000 0 UNK UNK UNK UNK WAES00101323 1
0171825 06/01/2001 TN 5.0 F 05/15/2001 On 10/12/2000 the patient presented to the physician's office with a "classic varicella rash". She had approximately 20-30 lesions, no crusting and no fever. It was noted that the patient had just finished a course of antibiotics for strep throat. Additional information has been requested. Y U 09/20/2000 10/12/2000 22 OTH OTH Antimicrobial Streptococcal pharyngitis WAES00101326 1
0171826 06/01/2001 OH 3.5 3 F 05/15/2001 Post vax, the patient went to a physician and was told she had "bites". It was reported that the "bug bites" kept reappearing. The bites are itchy. The patient is being treated with Aveeno to alleviate the itching. It was noted that the paitent has no fever, is acting fine, happy and acting herself. It was also noted that the patient had 4 lesions at the time, no blisters and they are not broken. The patient sought unspecified medical attention. FOLLOW-UP information received from a physician indicated that on approximatley 10/16/00, approximately 6 to 8 weeks after receiving Varivax SC on 08/18/00, the patient developed scattered, pruritic papules primarily on her extrmities. The patient recovered from her symptoms at the end of 10, 2000. An office evaluation concluded that the symptoms were likely secondary to insect bites. Additional information is not expected. Y U 08/18/2000 10/16/2000 59 OTH OTH UNK UNK WAES00101506 1
0171827 06/01/2001 PA 7.0 1 1 F 05/15/2001 On 09/10/2000 the patient was diagnosed with a "mild case of varicella in the office. The number of lesions was not documented. the patient's temperature was 99.1 orally. In follow up, the physician reported that the patient was seen on 09/30/2000 with "mild varicella". The physician reported that the patient recovered. No further information is available. Y Y 07/28/1995 09/30/2000 1891 PVT PVT UNK UNK WAES00101531 1
0171829 06/01/2001 MI 1.2 1 .0 M 05/15/2001 It was reported at the time of the vaccination that the patient had no adverse effects, however on 10/01/2000 the patient broke out with a rash. On 10/03/2000 he was seen by a physician who reported that the rash looked like varicella. Follow up information from a physician reported that on 10/07/2000 the patient recovered. No further information is available. Y Y 07/21/2000 10/01/2000 72 PUB OTH UNK NONE WAES00101661 1
0171830 06/01/2001 OH 21.0 21 F 05/15/2001 On 10/18/2000 the patient presented with a full blown case of chickenpox all over the body. The patient sought unspecified medical attention. Additional information has been requested. Y U 10/06/2000 10/18/2000 12 OTH OTH UNK UNK WAES00101726 1
0171831 06/01/2001 NJ 1.5 1 .5 F 05/15/2001 Immediately upon injection, the patient experienced "immediate sensitivity to vaccination at the site of the injection". The patient experienced a large welt, swelling and redness. Y Y 10/19/2000 10/19/2000 0 UNK UNK UNK UNK WAES00101811 1
0171832 06/01/2001 4.0 1 .8 F 05/15/2001 The physician reported that on 10/22/2000 the patient presented with chickenpox. The patient had 200 papular lesions, 5 vesicular lesions, and fever of 103F for 24 hours. Unspecified medical attetion was sought. Additional information has been requested. Y U 10/01/1997 10/22/2000 1117 OTH OTH UNK UNK WAES00101971 1
0171833 06/01/2001 NY U 05/15/2001 Information was received from a physician concerning 3 kindergarten aged children who were vaccinated with varicella virus vaccine live. Subsequently, the children developed chickenpox. Unspecified medical attention was sought. One other patient had a similar experience following exposure to varicella virus vaccine live. Additional information has been requested. Y U OTH OTH UNK UNK WAES00101973 1
0171834 06/01/2001 NC 5.0 2 .6 F 05/15/2001 On 10/21/2000, the patient's mother noticed a rash on her left buttocks and took her to an urgent care facility. The patient was treated with steroids. The patient was seen on 10/23/2000 and was diagnosed with greater than 60 clusters of lesions in the left S1 dermatome. The steroids were discontinued and the patient was then treated with acyclovir and atarax. The reporter believed that the patient's symptoms were worsened with the treatment of steroids. The PA also reported another patient's symptoms. Y U 10/30/1997 10/21/2000 1087 UNK UNK UNK UNK WAES00102006 1
0171835 06/01/2001 TX U 05/15/2001 Information has been received from a health professional concerning a patient who was vaccinated with varicella virus vaccine live. It was reported that the patient was totally covered by a vesicular rash 2 weeks post vaccination. Unspecified medical attention was sought. Additional information has been requested. Y U OTH OTH UNK UNK WAES00102048 1
0171836 06/01/2001 OH 6.0 6 F 05/15/2001 On 10/07/2000 the patient was seen in the physician's office "with lesions on abdomen/belly and back that were increasing in number (spreading)." The approximate number was unknown. It was reported that the patient's condition subsequently resolved. Follow up information indicated that the patient was not seen in the physician's office. The patient's experiences were reported by the patient's mom per phone. No further information is available. Y 09/28/2000 10/07/2000 9 UNK UNK NONE NONE WAES00102061 1
0171837 06/01/2001 CA 5.0 M 05/15/2001 Post vax, the physician reported that on 05/10/1996, the patient developed chickenpox after being exposed to his mother with shingles. Unspecified medical attention was sought. Additional information has been requested. Y U 05/10/1996 MIL OTH UNK Varicella exposure WAES00102076 1
0171838 06/01/2001 F 05/15/2001 On 10/19/2000, the patient developed a temperature and tiny bumps. Unspecified medical attention was sought. Additional information has been requested. Y U 10/15/2000 10/19/2000 4 OTH OTH Tylenol UNK WAES00102103 1
0171839 06/01/2001 MA 37.0 F 05/15/2001 On 10/10/2000 the patient developed a papular rash on her face, arms and neck. It was noted that the patient has no history of wild type varicella. Follow up information from a physician indicated that approximately one week later the patient recovered. No further information is available. Y 10/07/2000 10/10/2000 3 NONE PUB OTH NONE NONE WAES00102202 1
0171841 06/01/2001 NY F 05/15/2001 On 10/20/2000 the patient experienced chicken pox. Unspecified medical attention was sought. Additional information has been requested. Y U 09/20/2000 10/20/2000 30 OTH OTH UNK UNK WAES00102223 1
0171842 06/01/2001 CA 3.0 M 05/15/2001 Information has been received from a physician concerning a patient who was vaccinated with varicella virus vaccine live. In 2000 the patient developed herpes zoster on the right leg. Additional information has been requested. U 05/01/1999 OTH OTH NONE UNK WAES00102235 1
0171843 06/01/2001 NY 8.0 7 F 05/15/2001 Post vax, the patient developed chickenpox. The lesions are crusted over. The patient was taken to the ER. The patient received and albuterol treatment and was also treated with acyclovir. The physician indicated that the patient had approximately 200 lesions all over her body. It was reported that the patient subsequently recovered and was back at school. In follow up, on 10/30/2000 the physician indicated that the child had recovered. Y Y 06/25/1999 10/23/2000 486 Chest x-ray - "shadow" pneumonia being evaluated; considered not be be an infiltrate UNK UNK Vantin Otitis media UNK WAES00102316 1
0171844 06/01/2001 NY 7.0 U 05/15/2001 Post vax, the patient developed chicken pox. Unspecified medical attention was sought. Two other patients had a similar experience following exposure to varicella virus vaccine live. Additional information has been requested. Y U OTH OTH UNK UNK WAES00102358 1
0171845 06/01/2001 1.25 F 05/15/2001 On 10/20/2000, within a few hours following vaccination, evidence of pruritus was observed. On 10/21/2000, the patient developed dime-sized lesions on her inner thighs, which spread to her arms and chest and were worse in the morning. Subsequently, there were more than 50 lesions throughout the patient's body; one area broke out and resolved and then the lesions were found in another area. The patient was seen twice since the vaccination and 2 physicians did not feel that this was varicella, but was another virus. The patient's lesions and head cold persisted. Additional information has been requested. Y N 10/20/2000 10/20/2000 0 OTH OTH UNK Head cold UNK WAES00102416 1
0171846 06/01/2001 PA M 05/15/2001 Information has been received from a LPN concerning a male patient was on 06/16/1997 was vaccinated with varicella virus vaccine live and was vaccinated a second time on 06/21/1997 (product misuse) with varicella virus vaccine live. A booster shot of varicella virus vaccine live was administered in January, 1999. On 10/26/2000, the patient had another titer drawn which still showed no seroconversion. The patient was "just exposed to a hospitalized patient who had open, draining shingles". The patient sought unspecified medical attention. Additional information has been requested. Y N 05/21/1997 12/01/1998 559 serum varicella zoster - .73; serum varicella zoster - no seroconversion UNK UNK UNK herpes zoster exposure WAES00102430 1
0171847 06/01/2001 NJ 6.0 1 .1 M 05/15/2001 On 10/27/2000 or 10/25/2000 the patient presented with chickenpox. The nurse reported that the patient had a rash for 2 days consisting of 5-10 red itchy pustules/vesicular lesions with erythema at the base on his neck, back, face, and chest. It was reported that the physician expected more. The rash increased in number over 12-24 hours prior to the visit. Subsequently, the patient recovered from his experience. No further information is available. Y Y 11/06/1995 10/27/2000 1817 UNK UNK NONE WAES00102444 1
0171848 06/01/2001 IL 2.0 1 .1 F 05/15/2001 On 10/26/2000, the patient's mother was concerned that the patient might have chicken pox. On 10/27/2000 the child was diagnosed with chicken pox. The child was seen by the physician who indicated that the child "most likely" had chicken pox with well over 100 lesions. It was reported that the patient subsequently recovered. No further information is available. Y Y 03/11/1999 10/26/2000 595 PVT PUB Otitis media, upper respiratory infection UNK WAES00102451 1
0171849 06/01/2001 1.2 M 05/15/2001 Post vax, the patient "experienced a severe reaction to the vaccine. He has over 50 pox, some the size of a dime". It was reported that the mother was told "that this could continue for the next 3-4 weeks". The mother indicated that she was told that "there would only be a mild reaction", and she stated that "this is not a mild case of the chicken pox". Additional information has been requested. U UNK UNK UNK UNK WAES00102494 1
0171850 06/01/2001 PA 6.0 2 .1 M 05/15/2001 In October 2000, the patient developed asthma and it was noted that he was "forced to use steroids". On 10/27/2000 or 10/28/2000 the patient developed an outbreak of varicella. On 10/28/2000 the patient presented to the physician's office and it was reported that there were close to 50 lesions spread over his trunk, legs and arms. The patient was afebrile. There were no complication. The patient was treated with acyclovir. It was reported that at the time of the outbreak, the patient's steroids were being tapered. On an unspecified date, the patient recovered. No further information is expected. Y Y 01/18/1996 10/01/2000 1718 PVT OTH UNK UNK WAES00102541 1
0171851 06/01/2001 OH 2.0 1 .4 F 05/15/2001 On approximately 10/23/2000 the patient experienced 12 lesions on her body. As of 10/28/2000 there were 72 lesions. Unspecified medical attention was sought. On follow up, it was reported that on an unspecified date the patient recovered without any difficulty. Y Y 04/22/1999 10/23/2000 550 NONE PVT PVT NONE NONE WAES00102563 1
0171852 06/01/2001 NJ 5.0 4 M 05/15/2001 Initially it was reported by one nurse that the patient was seen by the doctor on 10/24/2000 with a cough and mild varicella-like rash over his trunk. In follow-up, another nurse reported that the patient developed varicella with mild to moderate amount of vesicles from 10/22/2000 lasting until 10/27/2000. The patient recovered 10/27/2000. Additional information has been requested. Y Y 05/17/1999 10/22/2000 524 serum varicella zoster - 3.60; serum varicella zoster - 3.33 PUB PUB Tuberculin purified protein UNK WAES00110018 1
0171853 06/01/2001 CA M 05/15/2001 Information has been received from a family member concerning a male who was vaccinated with varicella virus vaccine live (manufacturer unspecified). Subsequently, after taking an unknown chicken pox vaccine several years ago he developed the chicken pox. Additional information has been requested. U UNK UNK UNK UNK WAES00110024 1
0171854 06/01/2001 KS 1.5 1 .2 F 05/15/2001 On 10/31/2000, the patient developed 20+ lesions on her chest, back and arms showing dermatomal distribution and was subsequently diagnosed with herpes zoster. The health professional noted that no other symptoms were noted. Additional information has been requested. Y U 07/25/2000 10/31/2000 98 UNK UNK UNK UNK WAES00110033 1
0171855 06/01/2001 MO 5.0 2 .1 F 05/15/2001 On 10/24/2000, the patient broke out with chickenpox which gradually spread to 60-70 lesions distributed on both arms and legs and torso. The patient was afebrile and displayed normal activity. On 10/27/2000, the patient was seen by her physician, and treated for chicken pox. On 11/02/2000, the patient recovered. Additional information is not expected. Y Y 10/22/1997 10/24/2000 1098 UNK UNK Claritin Cleft palate repair, Pierre Robin syndrome, congenital anomaly, reactive airway disease, sulfa allergy, tracheotomy WAES00110054 1
0171856 06/01/2001 TX 1.2 1 .1 F 05/15/2001 On 10/12/2000 the patient developed a 2 cm indurated, four 6 mm warm clear vesicles at the injection site. The patient developed six 4mm red vesicles at the edge of the patient's lip. Subsequently, the patient was diagnosed with cellulitis secondary to the varicella virus vaccine live. The NP reported that on 10/19/2000, the patient recovered from the cellulitis. Unspecified medical attention was sought. Additional information has been requested. Y Y 09/26/2000 10/12/2000 16 Tuberculin skin test, 09/26/2000 OTH OTH UNK UNK WAES00110105 1
0171857 06/01/2001 PA 9.0 4 F 05/15/2001 On 10/24/2000, in the morning, the patient developed modified varicella disease < 50 lesions. She had an eruption of blisters with some scabbing < 50. Medical attention was sought. Prescription drug therapy was not required. On 10/30/2000, she recovered. No further information was provided. Y Y 12/04/1995 10/24/2000 1786 UNK UNK NONE NONE WAES00110112 1
0171858 06/01/2001 MI 5.0 1 .0 F 05/15/2001 On approximately 11/01/2000, the patient developed chickenpox. It was reported that the patient was "peppered with lesions". The child also had cold symptoms before the varicella occurred. The patient's sister had a similar experience following exposure to varicella virus vaccine live. Follow up information from a NP reported that the patient had greater than 100 lesions and that in November 2000 the patient recovered. No further information is available. Y 04/09/1996 09/28/2000 1633 PVT UNK UNK UNK ~Varicella (Varivax)~0~7.00~In Sibling WAES00110147 1
0171859 06/01/2001 MI 7.0 2 .1 F 05/15/2001 In October 2000, the patient began experiencing chicken pox. Many lesions are noted, over 50, "peppered with lesions". The patient's sister had a similar experience following exposure to varicella virus vaccine live. Follow up information from the NP indicated that the patient developed varicella greater than 100 lesions, "peppered" in October 2000. The patient subsequently recovered in November 2000. No further information is available. Y 06/13/1995 10/01/2000 1937 PVT OTH UNK Drug allergy, pollen allergy ~Varicella (Varivax)~0~5.00~In Sibling|~Varicella (Varivax)~0~5.00~In Sibling WAES00110148 1
0171860 06/01/2001 MI 1.9 1 .0 F 05/15/2001 The RN reported that on 08/27/2000, the patient had a fever of 103.2F. On approximately 08/28/2000, the patient experienced a varicella like rash with 100+ lesions. The patient was seen by a physician on 08/28/2000. The RN reported that on 08/28/2000, the patient had "multiple papule/pustules, red bases > 100, pox in throat. On an unspecified date the patient recovered from her experiences. No further information is available. Y Y 10/06/1999 08/27/2000 326 PVT UNK Upper respiratory infection Antibiotic allergy, drug allergy WAES00110168 1
0171861 06/01/2001 MD 3.0 1 .1 F 05/15/2001 On 10/31/2000, the patient experienced clinical varicella with multiple lesions. Unspecified medical attention was sought. Follow up information from the registered nurse indicated that the varicella was not related to the varicella virus vaccine live. No further information is available. Y U 09/08/1998 10/31/2000 784 UNK UNK UNK UNK WAES00110360 1
0171862 06/01/2001 MA F 05/15/2001 Information has been received from a nurse practitioner concerning a female who in approximately 1997 was vaccinated with varicella virus vaccine live. In approximately 1997 post vaccination, the patient experienced a "huge hive" at the injection site. Additional information has been requested. U UNK UNK UNK UNK WAES00110463 1
0171863 06/01/2001 IL 6.0 3 M 05/15/2001 On 11/01/2000 the patient developed 5 or 6 papules. On approximately 11/03/2000 the patient was seen at the physician's office and had approximately two dozen lesions, slighty vesicular and some had already scabbed over. The patient had a fever and headache one day. The nurse also reported that the child's lesions were "resolving quite nicely". On 11/07/2000 the patient recovered. No further information is expected. Y Y 08/22/1997 09/01/2000 1106 PVT PUB UNK WAES00110470 1
0171864 06/01/2001 NY 26.0 26 F 05/15/2001 Post vaccination, the patient developed a rash. Follow up information from the physician indicated that on 10/18/2000 the patient was vaccinated with the second dose of varicella virus vaccine live, subcutaneously in the left deltoid. On 10/20/2000 the patient developed a fever of 100.2F, which lasted for 3 days. On 10/22/2000, the patient developed a maculopapular rash which lasted approximately 1 week. The rash resolved and subsequently returned for one week. On approximately 11/17/2000, the patient recovered from the rash. Y 10/18/2000 10/20/2000 2 Diagnostic chemistry - negative, Diagnostic laboratory - parvovirus titre negative - history of parvoinfection, CBC - negative, Urinalysis - negative UNK UNK UNK Parvovirus infection WAES00110481 1
0171865 06/01/2001 MI 32.0 M 05/15/2001 The physician reported that the patient was vaccinated on 10/19/2000 and presented on approximately 11/01/2000 with erythema multiforme, ten red lesions and a low grade fever. Unspecified medical attention was sought. Additional information has been requested. Y U 10/19/2000 11/01/2000 13 UNK UNK UNK Penicillin allergy WAES00110488 1
0171866 06/01/2001 IL 0.7 F 05/15/2001 On 10/25/2000, the patient developed 50 vesicles and complained of itching. Other signs and symptoms were denied. On 10/27/2000, it was reported that the patient was recovering. The patient's mother stated that all the lesions were scabbing over and looked to be drying. Additional information has been requested. N 08/19/1996 10/25/2000 1528 PVT PVT UNK UNK WAES00110497 1
0171867 06/01/2001 OH 1.3 1 .4 F 05/15/2001 On 10/26/2000, the patient developed a "red papular rash on her face, trunk and extremities. The patient was fussy, vomiting and had a decrease in activity and diet". On 10/29/2000, the patient recovered. Y 10/15/2000 10/26/2000 11 OTH OTH UNK UNK WAES00110529 1
0171868 06/01/2001 DE M 05/15/2001 The physician reported that on 11/07/2000 the patient presented in her office with herpes zoster following C6 and C7 dermatome from upper arm to the hand. The patient was treated with acyclovir and prednisone. Additional information has been requested. Y U 11/01/1999 11/07/2000 372 UNK UNK Zyrtec WAES00110729 1
0171869 06/01/2001 MA 6.0 6 M 05/15/2001 On 11/02/2000, the patient presented with numerous large lesions and pustules on his body, number unknown, that were 7 to 9 cm, without papules with decentral vesiculation. He was diagnosed with early varicella. He also had positive cold symptoms. No tests were performed. He was treated with oral acyclovir for 5 days. The outcome was not provided. No further information is available. Per F/U 6/17/02: he was also treated with acyclovir (600mg po 4 times a day for 5 days). It was reported that the pt recovered on 11/8/00. No further info is available. Y Y 12/29/1997 11/01/2000 1038 Temp-12/22/97-low-grade fever PVT PUB Amoxil 1 tsp po tid X 10 days Otitis media, sore throat, low-grade fever UNK WAES00110732 1
0171870 06/01/2001 NJ 40.0 40 M 05/15/2001 On 10/16/2000 the patient experienced abdominal pain, joint pain, low back pain, headache, and blisters erupting. A rash started to appear sporadically, "a little bit all over" and there was burning at the injection site. The eruptions "scabbed over in 2 weeks" but the patient still had some pain and a headache. Unspecified medical attention was sought. Additional information has been requested. Per F/U 6/17/02: On 10/20/00, previously reported as 10/16/00, the pt experienced his symptoms as above. There were no lab tests done. Unspecified medical attention was sought. Outcome status was no reported. F/U info indicated that the pt also had left arm pain starting on 10/20/00. The pt recovered on 11/28/00. No further info is expected. Y Y 10/06/2000 10/20/2000 14 NONE per F/U 6/17/02 PVT PVT NONE per F/U 6/17/02 NONE per F/U 6/17/02 NONE per F/U 6/17/02 WAES00110806 1
0171871 06/01/2001 PA 23.0 23 F 05/15/2001 On approximately 10/27/2000, the patient "broke out" with a rash all over her body. The rash was described as "not necessarily itchy but uncomfortable". The patient's husband did not think it was chickenpox. Additional information has been requested. U 10/24/2000 10/27/2000 3 UNK UNK UNK WAES00110829 1
0171872 06/01/2001 NJ 6.0 4 F 05/15/2001 On 08/22/2000 the patient developed a varicella like rash with less than 100 lesions on her chest, abdomen and buttocks. No other symptoms were noted. Y Y 04/09/1998 08/21/2000 865 UNK UNK UNK WAES00110894 1
0171874 06/01/2001 NE 9.0 F 05/15/2001 Post vax, the patient developed a hard area at the injection site and "some penny size" bumps. The bumps were not chicken pox. The patient sought unspecified medical attention. Additional information has been requested. Y U 10/27/2000 10/27/2000 0 UNK UNK UNK UNK WAES00110908 1
0171875 06/01/2001 MA 8.0 5 F 05/15/2001 On 11/09/2000, the patient developed chickenpox with 20-30 lesions on the body. Follow up was received from a physician. This episode was not considered related to varicella virus vaccine live "as the vaccine was given on 09/04/1998". Additional information has been requested. U 09/04/1998 11/09/2000 797 UNK UNK UNK UNK WAES00110916 1
0171876 06/01/2001 MA 5.0 2 .1 M 05/15/2001 On 11/08/2000, the patient developed 50-100 lesions, rhinorrhea and a slight temperature. On 11/09/2000, the patient was seen for one day history of rash and fever and other signs and symptoms (unspecified) of illness. Diagnosis was chicken pox with approximately 50-100 lesions over his body, vesicles and papules. Subsequently, the patient recovered. No further information was available. Y Y 06/24/1997 11/08/2000 1233 PVT PUB NONE WAES00110921 1
0171877 06/01/2001 TX 37.0 F 05/15/2001 On 11/04/2000, the patient experienced 3 pox-like lesions and low grade fever. On 11-10-2000, the patient reported to her physician that she had "increased symptoms", severity or change unknown. Additional information has been requested. N 10/25/2000 11/04/2000 10 UNK UNK UNK UNK WAES00111033 1
0171878 06/01/2001 MD 2.0 1 .0 M 05/15/2001 On 11/08/2000 the patient was seen at the physician's office and had developed conjunctivitis and chicken pox with about 30 poxes over his abdomen, arms, back and legs with variety of sizes of red vesicular lesions and 2 with scabs. The patient had no fever and the lesions were itchy. No further information is expected. Y U 10/25/1999 11/08/2000 380 PVT PVT Amoxil Otitis media, sinusitis UNK WAES00111034 1
0171879 06/01/2001 MD 1.5 1 .1 F 05/15/2001 On 11/09/2000 the patient presented at an after hours clinic with a cough that started 2 or 3 weeks prior, a fever of 102F that started 11/07/2000, a scattered rash on the trunk and extremities, mixed macular papular and some possible vesicular. The patient was diagnosed with chickenpox. The patient recovered. No further information is expected. Y Y 05/19/2000 10/01/2000 135 UNK UNK albuterol cough amoxicillin allergy WAES00111184 1
0171880 06/01/2001 NE 2.0 2 .3 M 05/15/2001 On 11/11/2000, the patient developed "chickenpox all over". In follow up, the nurse practitioner reported that on 11/11/2000 the patient experienced nasal congestion, "clear coryza" and developed raised red papules and blisters scattered over the trunk, head and extremities, also in mouth and tongue. The nurse practitioner reported that the patient recovered from his experiences. Unspecified medical attention was sought. No further information is available. Y Y 11/02/2000 11/11/2000 9 UNK PUB haemophilus b conjugate vaccine, diptheria toxoid (+) pertussis NONE WAES00111205 1
0171881 06/01/2001 F 05/15/2001 The patient failed to seroconvert after 2 vaccinations with varicella virus vaccine live. Unspecified medical attention was sought. Additional information has been requested. Y U 04/02/2000 diagnostic lab - failed to seroconvert OTH OTH UNK UNK WAES00111348 1
0171882 06/01/2001 NY F 05/15/2001 The patient failed to seroconvert after 2 vaccinations with varicella virus vaccine live. Unspecified medical attention was sought. Additional information has been requested. Y U 06/01/2000 serum varicella zoster - failed to seroconvert OTH OTH UNK UNK WAES00111359 1
0171883 06/01/2001 MA 19.0 F 05/15/2001 After 2 vaccinations with varicella virus vaccine live, the patient's recent titer was negative. Unspecified medical attention was sought. In follow up, the RN reported that the patient agreed to have another titer before revaccination. In follow up, the RN reported the patient has not had another titer drawn. Additional information has been requested. Y U serum varicella zoster - negative titer OTH OTH UNK UNK WAES00111450 1
0171884 06/01/2001 PA 1.91 1 .9 F 05/15/2001 On 11/15/2000, the patient experienced less than 20 pox like lesions scattered on her arms and legs. She was also afebrile. The patient was seen in the physician's office. The patient recovered 11/30/2000. No additional information is expected. Y Y 10/28/1997 11/15/2000 1114 PVT PVT UNK WAES00111466 1
0171885 06/01/2001 IN 2.08 2 .1 F 05/15/2001 On 10/16/2000 the patient developed "cold symptoms" which she had for several days. She also developed several red spots. On 10/17/2000, the red spots had a yellow fluid filled center and were identified by daycare as chickenpox. The patient was treated with Benadryl for itching. The patient recovered 10/22/2000. No additional information is expected. Y 06/16/1998 10/16/2000 853 UNK UNK UNK Erythromycin allergy, sulfa allergy WAES00111494 1
0171886 06/01/2001 PA 11.0 6 M 05/15/2001 On approximately 10/19/2000, the patient had strep throat. On approximately 11/02/2000, the patient developed very mild chicken pox with approximately 20-30 lesions and no other symptoms. Lab tests revealed a negative titer for the serium varicella virus antibody test. Additionally, it was reported that the patient had 2 brothers who also developed chicken pox. The patient's mother, who had no previous confirmed case of chicken pox, was vaccinated on 07/10/1995. At the time of this report the mother had not developed any lesions or other symptoms. Additional information has been requested. Y U 07/10/1995 10/19/2000 1928 serum varicella zoster - negative UNK UNK UNK NONE ~Varicella (Varivax)~1~9.00~In Sibling|~Varicella (Varivax)~1~9.00~In Sibling WAES00111528 1
0171887 06/01/2001 IL 7.0 5 F 05/15/2001 On 11/16/2000 the patient developed chicken pox. Unspecified medical attention was sought. In follow up, the physician's office indicated that the patient developed a rash and not chicken pox. No further information was reported. Y U 04/06/1999 11/16/2000 590 UNK UNK UNK UNK WAES00111540 1
0171888 06/01/2001 OH 1.0 1 .0 F 05/15/2001 On 10/28/2000 the patient developed 2 or 3 vesicles on her chest and one 6cm vesicle on her buttock, and had a low grade fever. On 11/01/2000, the physician diagnosed the patient with varicella. The patient was treated with Neosporin and Infant Tylenol. The patient subsequently recovered. Additionally, the pharmacist also reported that her 12 month old fraternal twin had similar experiences following exposure to varicella virus vaccine live. Follow up information was received from a physician which indicated that there was no illness or pre-existing conditions at the time of vaccination. The reporting physician felt that there was no adverse experience for this patient. Additional follow up received from the physician indicated that the patient's mother called the office "ten days later with what sounded like an MMR rash, no Varivax. Additional information is not expected. Y Y 10/18/2000 10/28/2000 10 PVT OTH Dental disorder, otic infection NONE ~Varicella (Varivax)~1~1.00~In Sibling|~Varicella (Varivax)~1~1.00~In Sibling WAES00111541 1
0171889 06/01/2001 IL 1.08 M 05/15/2001 On approximately 11/02/2000, 2 weeks post dose, the patient broke out in a papular, vesicular appearing rash. On approximately 11/09/2000, about 1 week into the rash, it turned into roundish plaques in the same areas of the papular rash. The rash was diffuse all over not just at the injection site. Patient was not febrile but did exhibit cold symptoms. Additional information has been requested. U 10/19/2000 11/02/2000 14 UNK UNK UNK UNK WAES00111554 1
0171890 06/01/2001 GA 1.0 1 .0 F 05/15/2001 On 11/10/2000 the patient broke out with a chickenpox like rash. The patient recovered from the rash on 11/12/2000. No further information is available. Y 11/08/2000 11/10/2000 2 PVT PUB UNK WAES00111607 1
0171891 06/01/2001 MN 1.0 1 .0 F 05/15/2001 On approximately 11/10/2000, the patient developed 10-15 chickenpox lesions in the diaper area and on the upper thighs that resolved in one week. No further information is expected. Y 10/23/2000 11/10/2000 18 UNK UNK UNK WAES00111656 1
0171892 06/01/2001 PA 9.0 4 M 05/15/2001 On approximately 10/19/2000, the patient had strep throat. On approximately 11/14/2000, the patient developed very mild chicken pox with approximately 20-30 lesions and no other symptoms. A titer for the serum varicella virus antibody test was not drawn. Unspecified medical attention was sought. Additionally, it was reported that the patient had 2 brothers who also developed chicken pox. The patient's mother, who had no previous confirmed case of chicken pox, was vaccinated on 07/10/1995. At the time of this report the mother had not developed any lesions or other symptoms. Additional information has been requested. Y U 07/10/1995 10/19/2000 1928 UNK UNK UNK NONE ~Varicella (Varivax)~1~11.00~In Sibling|~Varicella (Varivax)~1~11.00~In Sibling WAES00111658 1
0171893 06/01/2001 TN 1.0 1 .1 M 05/15/2001 On 11/10/2000 the patient developed "little blisters" and was treated with cortisone cream. The physician reported that the patient had a rash on the right of the midline of the back to the midline front of the trunk. Therapy with coritsone was discontinued. Subsequently, on 11/16/2000, the patient was diagnosed with mild shingles and was seen by his physician on 11/17/2000. The shingles lasted for 1 week. No further information is expected. Y Y 02/29/2000 11/10/2000 255 UNK UNK UNK UNK WAES00111659 1
0171894 06/01/2001 TX 37.0 37 F 05/15/2001 On 11/06/2000 the patient experienced a rash, fever, arm soreness and site burning. The patient had 20 lesions that were noted with draining and crusting of a few. The patient's fever lasted for 5 days. In follow up, the physician reported that "no work-up was done". Additional information has been requested. Y 10/24/2000 11/06/2000 13 UNK UNK Claritin Allergy WAES00111671 1
0171895 06/01/2001 OH 1.0 1 .0 M 05/15/2001 On approximately 10/21/2000 or 10/28/2000, the patient experienced a red, dot like, non-raised rash on the trunk and a low grade fever. Subsequently, by 10/26/2000 the patient recovered. Additionally, the pharmacist reported that her 12 month old female fraternal twin developed varicella. In follow-up the physician reported "no adverse event". Subsequent to the physician's follow up, additional follow up from the pharmacist indicated that the event onset date was 10/28/2000 at 19:00 hours and that the event resolved over one to three days. The fever was reported to be less than 24 hours. No further information was available. Y 10/18/2000 10/28/2000 10 PVT OTH Penicillin allergy ~Varicella (Varivax)~~1.00~In Sibling WAES00111674 1
0171896 06/01/2001 VA 1.25 1 .3 M 05/15/2001 The patient presented with a mild case of chicken pox in 1999 and again on 11/13/2000. No further information is expected. This patient was also mentioned in WAES 01010774. U 06/23/1997 UNK UNK cafe au lait spot, penicillin allergy WAES00111679 1
0171897 06/01/2001 VA 1.5 1 .5 F 05/15/2001 On 10/31/2000 the patient presented with chicken pox. Unspecified medical attention was sought. No further information is available. Y U 10/24/2000 10/31/2000 7 PVT PVT UNK WAES00111885 1
0171898 06/01/2001 1.21 1 .2 F 05/15/2001 On 11/03/2000 the patient presented with chickenpox. Additional information has been requested. Y U 03/28/1996 11/03/2000 1681 UNK UNK UNK UNK WAES00111686 1
0171899 06/01/2001 VA 1.2 1 .2 F 05/15/2001 On 11/13/2000 the patient presented with chicken pox. Additional information has been requested. Y U 01/17/1998 11/13/2000 1031 UNK UNK UNK UNK WAES00111687 1
0171900 06/01/2001 VA 1.0 1 .0 M 05/15/2001 On 10/19/2000, the child presented with a varicella rash and a 103F fever. The patient's outcome was unknown. No additional information is expected. Y U 03/10/1997 10/19/2000 1319 PVT UNK UNK UNK WAES00111688 1
0171901 06/01/2001 PA 7.0 1 .9 M 05/15/2001 On approximately 10/19/2000 the patient had strep throat. On approximately 11/14/2000 the patient developed ver mild chicken pox with approximately 20-30 lesions and no other signs or symptoms. Unspecified medical attention was sought. Additionally, it was reported that the patient had 2 brothers who also developed chicken pox. The patient's mother was vaccinated on 07/10/1995, and at the time of this report had not developed any lesions or other signs or symptoms. Additional information has been requested. Y U 07/10/1995 10/19/2000 1928 UNK UNK UNK NONE ~Varicella (Varivax)~1~9.00~In Sibling|~Varicella (Varivax)~1~9.00~In Sibling WAES00111719 1
0171902 06/01/2001 MI 4.0 4 M 05/15/2001 On 11/09/2000, the patient developed a vesicular rash around the site of immunization. It was reported that the patient subsequently recovered. No further information is expected. Y 10/23/2000 11/09/2000 17 OTH OTH Rocephin NONE WAES00111728 1
0171903 06/01/2001 IL 7.0 M 05/15/2001 On 11/18/2000 the child presented with 19-20 chicken pox lesions. Unspecified medical attention was sought. The nurse reported that the patient recovered from the chicken pox. No further information is available. Y Y 07/31/1995 11/18/2000 1937 PVT OTH UNK UNK WAES00111765 1
0171904 06/01/2001 FL 1.0 0 1 M 05/15/2001 On 11/09/2000 the patient experienced greater than 30 lesions on his body. The lesions were described as pruritic fluid-filled vesicles. Additional information has been requested. U 11/24/1998 11/09/2000 716 PVT PVT UNK Speech disorder WAES00111833 1
0171905 06/01/2001 NY 35.0 35 F 05/15/2001 On 11/15/2000 the patient had a sore arm. On 11/17/2000 a bump appeared on the injection site. The physician reported that on 11/18/2000, the patient had "actual pox x 3 at the site". The patient reported that on 11/21/2000, that she had several pox around the injection site. The physician reported the patient recovered from the sore arm and the pox at the injection site. No further information is expected. Y 11/07/2000 11/15/2000 8 UNK UNK Metamucil Amoxicillin allergy, penicillin allergy WAES00111871 1
0171906 06/01/2001 PA 2.08 2 .0 M 05/15/2001 On 11/21/2000 the patient had developed 50 lesions spread over his entire body and a low grade fever and was diagnosed with varicella. The patient recovered. No further information is expected. Y 06/10/1996 11/21/2000 1625 UNK UNK Poly-vi-flor tablets UNK WAES00111889 1
0171907 06/01/2001 NJ 5.0 1 .3 F 05/15/2001 On 11/10/2000 at 14:35 hours, the patient was diagnosed with chicken pox following exposure to another child with chicken pox. Subsequently, the patient recovered. No further information is available. Y Y 02/19/1997 11/10/2000 1360 NONE UNK UNK Varicella exposure WAES00111958 1
0171908 06/01/2001 CA 1.0 M 05/15/2001 Post vax, the patient experienced a varicella like rash on his lower body. Medical attention was sought from a health care provider. The health care provider was not certain if the "break out was diaper rash or a reaction to the injection". Additional information has been requested. Y U UNK UNK UNK UNK WAES00111968 1
0171909 06/01/2001 NJ F 05/15/2001 On 11/20/2000 the patient experienced a strip of red above the infection site and 4 raised bumps. On 01/19/2001 (6 weeks after the vaccination) the patient developed roseola. Follow up information received from the physician's office indicated that they did not have any record of a reaction. No further information is available. U 11/10/2000 11/20/2000 10 UNK UNK UNK UNK WAES00112077 1
0171910 06/01/2001 TX 0.8 0 .8 M 05/15/2001 Originally the nurse reported that "no reactions were observed at present". In follow up, the nurse reported that the patient was "just more clinging to her for a couple of days". The mother thought that he had a 99F temperature, but "did not check it". Additional information is not expected. U 11/27/2000 UNK PUB Otitis media, upper respiratory infection WAES00112148 1
0171911 06/01/2001 PA F 05/15/2001 Information has been received from a LPN concerning a female who in 1997 was vaccinated with 2 doses of varicella virus vaccine live. Subsequently, the patient tested negative for varicella. Additional information has been requested. Y U Serum varicella zoster - negative UNK UNK UNK UNK WAES00112152 1
0171912 06/01/2001 OH 8.0 F 05/15/2001 On 11/24/2000 the patient developed 12 pox. Additional information has been requested. Y U 08/14/1995 11/24/2000 1929 UNK UNK UNK UNK WAES00112361 1
0171913 06/01/2001 OH 6.0 F 05/15/2001 On 11/24/2000 the patient's mother phoned the office and reported that her child had a rash with approximately 150 pox. She had no other symptoms. Unspecified medical attention was sought. Additional information has been requested. Y U 08/14/1995 11/24/2000 1929 UNK UNK UNK UNK WAES00112371 1
0171914 06/01/2001 OH U 05/15/2001 Post vax, the patient did not serconvert. The nurse reported that they wanted to give the patient a booster shot, but the patient was on valacyclovir. Unspecified medical attention was sought. Additional information has been requested. Y U serum varicella zoster - did not seroconvert UNK UNK Valacyclovir UNK WAES00120015 1
0171915 06/01/2001 MA 9.0 6 M 05/15/2001 The patient's mother called the physician's office to let them know that her child had been sent home from school on 11/30/2000 with "chickenpox". In follow up, the patient recovered form this experience. No further information is available. Y Y 03/25/1998 11/30/2000 981 PVT UNK UNK UNK WAES00120032 1
0171916 06/01/2001 KY 3.0 1 .0 M 05/15/2001 On 11/29/2000 the patient broke out in a rash. In follow up the RN reported about 20 or so vesicular lesions that itch in the center of the back and on his right calf. Some lesions were already scabbed over on 12/01/2000. The patient was treated with Benadryl and Tylenol. Y N 01/07/1998 11/29/2000 1057 UNK UNK UNK WAES00120136 1
0171917 06/01/2001 TX U 05/15/2001 Information has been received from a RN concerning 2 patients who were vaccinated with varicella virus vaccine live. Subsequently, the patients experienced herpes zoster. Their outcomes were unknown. Additional information has been requested. The RN also reported that experience of a 5 year old male who was also vaccinated with varicella virus vaccine live. U PUB UNK UNK UNK WAES00120225 1
0171918 06/01/2001 PA 1.0 1 .0 M 05/15/2001 On 12/04/2000 the patient developed 6 pox lesions, a runny nose and nasal congestion. Additional information has been requested. U 11/15/2000 12/04/2000 19 UNK UNK UNK UNK WAES00120251 1
0171919 06/01/2001 M 05/15/2001 Post vax, on approximately 12/04/2000, the patient experienced a "full blown pox" - chicken pox. Additional information has been requested. U 12/04/2000 UNK UNK UNK UNK UNK WAES00120278 1
0171920 06/01/2001 OH 6.0 1 .5 F 05/15/2001 Post vax, on 11/20/2000, the patient was exposed to a child who had chicken pox at school. On 11/11/2000 the patient was seen in her physician's office and chicken pox was confirmed by the physician. The patient then developed 30 red spots with blisters on top on numerous areas of her body. The patient had a fever of 102F. The patient was treated with Benadryl as needed for the itching, Aveeno Bath and calamine lotion. In November 2000 the patient also had a vaginal yeast infection and was treated with Diflucan. On 12/08/2000 the patient recovered. No further details were provided. Y Y 11/06/1995 11/21/2000 1842 NONE PVT PVT UNK Varicella exposure WAES00120447 1
0171921 06/01/2001 IA 1.0 F 05/15/2001 Post vax, the patient recently developed "water warts". In follow up, the physician's office reported that, "the mother who reported that it was a reaction to the chickenpox apparently misunderstood the doctor, the "water warts" had nothing to do with the vaccine. Additional information has been requested. U UNK UNK UNK UNK WAES00120483 1
0171922 06/01/2001 IA 36.0 M 05/15/2001 On 11/28/2000 the patient's 1 year old son was vaccinated with varicella virus vaccine live in the right leg, subcutaneously, and MMR in the left leg subcutaneously. The patient's son had no reaction to the vaccines. The patient was exposed to his son 24 hours a day. Subsequently, on 12/02/2000 the patient developed herpes zoster in the upper thigh and lower torso area. The patient had blistering yellow fluid lesions on his left trunk to midline only. He estimated 50-100 of these lesions, which seemed to cluster in groups of about 10. The lesions were distributed on the left side of the body to midline, up to the waistline, down to the upper thigh/hip and buttocks area. The herpes zoster was very painful. The reported stated, "felt like spilled battery acid on my skin". The herpes zoster began itching with the healing process when drying up. At the time of the report the patient was under the care of his local physician and was improving. Additional information has been requested. Y N 12/02/2000 DNA - scabs ran twice; inadequate (no betaglobin) UNK UNK albuterol Varicella, asthma WAES00120491 1
0171923 06/01/2001 NY 39.0 39 F 05/15/2001 On 12/06/2000 the patient complained of "local tenderness, redness and a warm feeling at the injection site". The patient also experienced itching all over her body. The patient had no fever and no rash. Unspecified medical attention was sought. Additional information has been requested. Y U 12/04/2000 12/06/2000 2 UNK UNK UNK UNK WAES00120507 1
0171924 06/01/2001 GA U 05/15/2001 Post vax, the patient developed full blown chickenpox with 250-500 lesions. Additional patients had a similar experience following exposure to varicella virus vaccine live and the above mentioned patient. No further information is available. U OTH OTH UNK Leukemia ~Varicella (Varivax)~~0.00~In Sibling WAES00120576 1
0171925 06/01/2001 FL 1.08 U 05/15/2001 Post vax, the patient experienced hives. The patient recovered from their experience. The physician also reported 4 other patients who developed hives after being vaccinated with varicella virus vaccine live. Additional information has been requested. Y Y UNK UNK UNK WAES00120814 1
0171926 06/01/2001 32.0 32 F 05/15/2001 Post vax, in December the patient developed a varicella like rash. Additional information has been requested. U 11/27/2000 UNK UNK UNK UNK WAES00120832 1
0171927 06/01/2001 IL 7.0 7 F 05/15/2001 On 11/18/2000 the patient presented to the physician's office with "4 lesions with crusting, all on her right side". The lesions did not cross the patient's midline. The physician stated that she did not actually see the patient, but that another physician saw the patient and diagnosed herpes zoster. As of 12/12/2000 the patient recovered from her herpes zoster lesions/scabs. Additional information has been requested. Y Y 11/11/2000 11/18/2000 7 UNK UNK UNK UNK WAES00120927 1
0171928 06/01/2001 NY 2.0 0 .0 M 05/15/2001 The patient's mother reported that on approximately 12/07/2000 the patient broke out in a rash. The patient had more than 50 lesions. The rash began in the front and spread to the face and neck area. One lesion, located near the under arm area, appeared to be blistering. Unspecified medical attention was sought. In follow up, the patient's mother reported that her son had been diagnosed with "PLEVA not chicken pox". Additional information has been requested. Y U 10/27/1998 12/07/2000 772 UNK UNK Duricef UNK WAES00120974 1
0171929 06/01/2001 ND U 05/15/2001 Information has been received from a physician concerning patients who in approximately 1998 or 1997 were vaccinated with varicella virus vaccine live. Subsequently the patients experienced "breakthrough chickenpox". Unspecified medical attention was sought. Additional information has been requested. Y U UNK UNK UNK UNK WAES00120897 1
0171930 06/01/2001 CA 1.08 1 .1 F 05/15/2001 On 12/10/2000 the patient experienced an "extreme case" of varicella. Unspecified medical attention was sought. According to the physician, there was no history of exposure. Additional information has been requested. Y U 11/13/2000 12/10/2000 27 UNK UNK UNK UNK WAES00121025 1
0171931 06/01/2001 FL 4.0 4 F 05/15/2001 On 12/11/2000 at 15:00 hours the patient awoke from her nap and had developed a swollen face, ecchymosis around the eyes and sleepiness. The patient was treated with Zyrtec. Subsequently, on 12/12/2000 the patient recovered. Additional information is not expected. Y Y 12/11/2000 12/11/2000 0 PVT PVT UNK UNK WAES00121115 1
0171932 06/01/2001 TX 2.0 1 .0 M 05/15/2001 On 12/14/2000 the patient experienced chickenpox with a rash or lesions. The lesions were papular/pustular and all over the trunk, legs and arms. The patient was itching and crying. Medical attention was sought. Follow up from the physician reported that the lesions were dry and he will obtain a specimen for analysis. A specimen was obtained on 12/15/2000. Y N 01/15/1999 12/14/2000 699 DNA - PCR analysis, adequate specimen, no VZV; DNA - positive for beta globin OTH OTH NONE NONE WAES00121137 1
0171933 06/01/2001 MD 1.0 1 .1 M 05/15/2001 Post vax, the RN reported that on 12/08/2000 the patient developed chicken pox. Additional information has been requested. Y U 12/08/2000 12/08/2000 0 UNK UNK Prevnar NONE WAES00121143 1
0171934 06/01/2001 FL 2.0 U 05/15/2001 Post vax, the patient experienced hives and sought unspecified medical attention. The patient subsequently recovered. The physician also reported 4 other patients who developed hives after being vaccinated with varicella virus vaccine live. Additional information has been requested. Y Y UNK UNK UNK UNK WAES00121189 1
0171937 06/01/2001 CA 9.0 6 M 05/15/2001 Post vax, the LPN reported that on 12/11/2000 the patient presented with varicella, fever and blisters. Unspecified medical attention was sought. In follow up, the LPN nurse reported that on 12/11/2000 the patient developed a fever of 102F, congestion and lesions on his head, face and torso. The patient's outcome was unknown. Additional information is not available. Y U 01/27/1998 12/11/2000 1049 PVT PVT UNK UNK WAES00121274 1
0171938 06/01/2001 CA 8.0 6 F 05/15/2001 Post vax, the medical assistant reported that on 12/12/2000, the patient "broke out with chicken pox". Unspecified medical attention was sought. In follow up the physician reported that the patient recovered. The patient's siblings had a similar experience following exposure to varicella virus vaccine live. No further information is available. Y Y 04/28/1998 12/12/2000 959 PVT PVT Ritalin UNK ~Varicella (Varivax)~1~6.00~In Sibling|~Varicella (Varivax)~2~0.00~In Sibling WAES00121276 1
0171939 06/01/2001 MD U 05/15/2001 Information has been received from a RN concerning at least 3 patient who were vaccinated with varicella virus vaccine live. The RN reported that the patients developed chicken pox after immunization. Unspecified medical attention was sought. Additional information has been requested. Y U UNK UNK UNK UNK WAES00121300 1
0171941 06/01/2001 CA 1.3 1 .3 F 05/15/2001 Post vax, the student nurse reported that on approximately 12/15/2000 the patient came to the office and there was a "golf ball size pink patch with a lump" at the injection site. The lump does not itch or hurt. Unspecified medical attention was sought. Additional information has been requested. Y U 11/18/2000 12/15/2000 27 UNK UNK UNK UNK WAES00121354 1
0171942 06/01/2001 TX 4.0 2 .2 F 05/15/2001 Information has been received from a physician concerning a patient who on 09/15/1997 was vaccinated with varicella virus vaccine live that expired on October 1999. The physician reported that the varicella virus vaccine was reconstituted with a diluent lot #0999D, date of expiration January 2001. However, this lot # corresponds with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live. The expiration date provided for the diluent, January 2001, does not correspond with the expiration date for this particular lot of MMR virus vaccine live (expiration 07/16/1998). On 12/04/2000, the patient had an upper respiratory infection but no evidence of varicella was noted. On 12/12/2000, the patient presented to the physician with herpes zoster on the right posterior medial thigh and leg with 30% clustering blisters. It was noted that the child's mother does not want any testing for VZVID performed. Additional information has been requested. U 09/15/1997 12/04/2000 1176 UNK UNK UNK UNK WAES00121372 1
0171943 06/01/2001 PA M 05/15/2001 Post vax, the patient developed chicken pox. Additional information has been requested. U OTH OTH UNK UNK WAES00121395 1
0171944 06/01/2001 CA U 05/15/2001 Post vax, the medical assistant reported that on 12/12/2000 the patient "broke out with chicken pox". Unspecified medical attention was sought. The patient's siblings had a similar experience following exposure to varicella virus vaccine live. Additional information has been requested. Y U 11/19/1999 12/12/2000 389 UNK UNK UNK UNK ~Varicella (Varivax)~1~6.00~In Sibling|~Varicella (Varivax)~1~8.00~In Sibling WAES00121416 1
0171945 06/01/2001 CA 6.0 3 M 05/15/2001 Post vax, the medical assistant reported that on 12/12/2000, the patient "broke out with chicken pox". In follow up, the physician reported that on 11/30/2000, the patient "developed clinical varicella". Unspecified medical attention was sought. The physician reported that the patient recovered. The patient's siblings had a similar experience following exposure to varicella virus vaccine live. No further information is available. Y Y 04/21/1998 11/30/2000 954 PVT PVT Ritalin UNK ~Varicella (Varivax)~2~0.00~In Sibling|~Varicella (Varivax)~0~8.00~In Sibling WAES00121417 1
0171946 06/01/2001 MI U 05/15/2001 Information has been received from a RN concerning 2 or 3 children who were "previously" vaccinated with varicella virus vaccine live at an adolescent mental health facility. "Recently" in approximately 2000, when the patient's titers were drawn, they failed to seroconvert or their titers were low. No further details were provided. Additional information is not expected. Y U diag lab - titer failed to seroconvert or titers were low OTH OTH UNK UNK WAES00121467 1
0171947 06/01/2001 LA 6.0 F 05/15/2001 Post vax, the patient presented with chicken pox on 11/24/2000. The patient had "postulates/lesions, and a modified case of chicken pox, and her temperature ran 99-100F. The patient was cleared to return to school. No further information is available. Y Y 11/24/2000 PVT PVT UNK UNK WAES00120103 1
0171948 06/01/2001 NY U 05/15/2001 Post vax, in approximately 2000, the patient developed shingles. Unspecified medical attention was sought. No additional information is expected. Y U UNK UNK UNK UNK WAES00121477 1
0171949 06/01/2001 NY 2.8 1 .8 M 05/15/2001 Post vax on 12/12/2000 the patient developed shingles on his upper right thigh, corresponding with the injection site, which was described by the physician as a rash. The rash became "bumpy" which spread and blistered. The rash did not itch and was not painful. The patient was seen by a pediatrician and a dermatologist and was diagnosed with herpes zoster. The patient was treated with acyclovir for 10 days and subsequently recovered. Additional information is not expected. Per F/U 6/17/02: There was no illness at the time of vaccination. On 12/12/00 (previously reported as 12/12/99), the pt developed shingles on his upper right thigh which was described by the physician as a rash. The physician reported that the pt's sister (WAES 01032315) had a similar experience. Additional info is not expected. Y Y 04/16/1997 12/12/2000 1336 PVT UNK UNK NONE UNK Varicella~Varicella (Varivax)~~2.70~In Patient WAES00121480 1
0171950 06/01/2001 MO 52.0 F 05/15/2001 Post vax on approximately 08/14/2000, the patient developed shingles with patches on her chest, back and lower on the waist. The patient's rash lasted for a while and the area was still discolored. Unspecified medical attention was sought. Additional information has been requested. Y Y 07/24/2000 08/14/2000 21 UNK UNK UNK UNK WAES00121607 1
0171951 06/01/2001 MI 1.08 1 .1 M 05/15/2001 Post vax on 12/05/2000 the patient developed chicken pox that started off as pustules on his left cheek. Subsequently, the patient had three pustules appear on this right axilla, one on his abdomen. The child was acting well. Upon physical examination the patient had a lesion on his left cheek that was erythematous and appears to have begun to scab. A similar lesion on the inner aspect of the right upper arm was noted. Near that lesion there was a pustule on the lateral trunk wall, on right, there was another pustule lesion that has the appearance of varicella. There was also another lesion at the base of the neck on the left that was erythematous. No actual fluid filled blisters were noted. The patient was treated with Tylenol as needed. Additional information is not expected. Y U 11/10/2000 12/05/2000 25 PVT PUB Eczema WAES00121611 1
0171952 06/01/2001 MI 5.0 1 .3 F 05/15/2001 Post vax on 12/01/2000, the patient was seen at the physician's office with complaints of very itchy, red bumps for 1 day, headache and a stomach ache on 11/30/2000, which was fine as of 12/01/2000. The physician noted in the patient's chart that the patient had chicken pox lesions on her abdomen, chest and a few on her arms. Her temperature was 97.0F. No further details were provided. Additional information has been requested. Y Y 06/05/1996 11/30/2000 1639 PVT OTH UNK UNK WAES00121895 1
0171953 06/01/2001 MA 6.0 3 F 05/15/2001 Post vax, the patient presented on 12/20/2000 with 20-25 vesicular lesions scattered mostly on her trunk with a few on her face. There were no other symptoms. In follow up, the patient was seen in the physician's office on 12/20/2000 with a 1 day history of an itching rash which began 12/20/2000, low grade temperature in the AM was noted and 25 + veiscles scattered over the body. The patient subsequently recovered from her experiences. No additional information is available. Y Y 05/19/1997 12/20/2000 1311 PVT UNK UNK Sulfa allergy WAES00121744 1
0171954 06/01/2001 IA 2.0 1 .4 F 05/15/2001 Post vax on approximately 12/14/2000, the patient developed chicken pox that lasted over 1 week in duration. There were over 40 "poxes" on the patient located all over her body. On 12/30/2000 the patient recovered. Unspecified medical attention was sought. The nurse also reported other patients that developed chicken pox. Y Y 09/01/1999 12/14/2000 470 OTH PVT UNK UNK WAES00121843 1
0171955 06/01/2001 MI 23.0 22 F 05/15/2001 Post vax, on 12/18/2000, the patient was negative for varicella virus serum antibodies. Unspecified medical attention was sought for the patient. No additional information is expected. Y N 10/29/1999 12/18/2000 416 Serum varicella zoster - negative UNK OTH UNK UNK WAES00121872 1
0171956 06/01/2001 OH 6.0 M 05/15/2001 Post vax, by 11:00 pm on 12/21/2000, the patient experienced projectile vomiting, abdominal cramps, nausea and had no appetite. Unspecified medical attention was sought. The patient's outcome was unknown. Additional information has been requested. Y U 12/21/2000 12/21/2000 0 UNK UNK UNK UNK WAES00121876 1
0171957 06/01/2001 TN 5.0 1 .0 M 05/15/2001 Post vax, a few months ago from the time of the report, the patient developed varicella. Subsequently, the patient recovered. Unspecified medical attention was sought. Y Y 02/09/1996 UNK UNK UNK UNK WAES00121994 1
0171958 06/01/2001 MI 6.0 1 .0 M 05/15/2001 Post vax, on approximately 12/04/2000 the patient was exposed to chicken pox at school. Two weeks later on 12/18/2000, the patient developed chicken pox lesions. The chicken pox started off and on at the patient's head, itching back and front. The physician described the patient's chicken pox lesions as "multiple" appearing on his trunk, abdomen, a few on his face, and a few on his arms and extremities. The patient was treated with Calamine Lotion, Benadryl and Advil. No further details were provided. Additional information has been requested. Y U 06/26/1995 12/18/2000 2002 OTH OTH UNK Varicella WAES00122028 1
0171959 06/01/2001 OH 5.0 3 M 05/15/2001 The mother reported that the patient has had 3 diagnosed cases of chicken pox. The first case was in approximately September 1998. The patient had 3 or 4 lesions on his arm but he had no fever. Then in March 2000, he presented with 20 lesions and a fever. On 12/22/2000, he presented again wtih 90 lesions and no fever. It was reported the patient recovered early January 2001. The physician's office did not have documentation on the breakthrough rash occurring in the Fall of 1998, or March 2000 that the mother reported. No additional information is expected. Y Y 04/14/1998 Serum varicella zoster - positive UNK UNK NONE NONE WAES00122085 1
0171960 06/01/2001 MI 5.0 5 F 05/15/2001 Post vax on 12/19/2000 the patient complained of feeling dizzy. On 12/20/2000 at approximately 10:00 am the patient had a headache and broke out in a rash described as chickenpox. It was reported that on 12/27/2000 the patient had about 60 lesions and a temperature of 102.9F. Subsequently the patient recovered. No additional information is expected. Y 12/18/2000 12/19/2000 1 PVT OTH NONE WAES00122089 1
0171961 06/01/2001 KY 1.5 1 .1 F 05/15/2001 In approximately November 2000, 3 months post vaccination, the patient developed shingles. Unspecified medical attention was sought. Additional information has been requested. Per F/U 6/17/02: Information has been received from a physician and a pt's mother concerning an 18 month old Caucasian female with asthma, who had been born premature at 32 weeks, who on 9/16/00, was vaccinated SC with the 1st dose of varicella virus vaccine live (lot 634502/0538K) (0.5ml) in the left arm. There were no illnesses at the of time of vaccination. On 12/17/00, the pt developed shingles. The pt broke out in a rash on her back described as "vesicular and red raised patches which were tender to palpitation". The pt also had "3 vesiculopapules on her abdomen". It was reported that dermatome was involved. The pt did not have a fever. The pt's pain had not been assessed because she "was an infant, approx. 18 months at the time of the breakout". It was reported that the pt was crying and irritable at night. The pt did not have a history of chickenpox. The pt had not been recently exposed to chickenpox or herpes zoster. Unspecified medical attention was sought. The herpes zoster lasted 2-3 weeks until it was all gone. The pt recovered from her experience. No further info is available. Y Y 09/16/2000 12/17/2000 92 PVT PVT UNK Per F/U 6/17/02: prematurity; asthma NOS WAES00122102 1
0171962 06/01/2001 MI 7.0 1 .9 M 05/15/2001 Post vax, on 12/16/2000 the patient broke out in a maculopapular vesicular rash with an erythemous base on his abdomen, back, face and extremities. The reported stated that the impression was chicken pox. The patient was treated with Zovirax for 5 days but the patient's symptoms persisted. Unspecified medical attention was sought. Additional information has been requested. Y N 09/26/1995 12/16/2000 1908 UNK UNK NONE UNK WAES00122195 1
0171963 06/01/2001 NY M 05/15/2001 Post vax on 12/28/2000 the patient experienced chicken pox. He had a mild fever with about 20 lesions some of which were vesicular. Medical attention was not sought for the child. His outcome was not known. Additional information has been requested. U 12/28/2000 UNK UNK UNK UNK WAES00122217 1
0171964 06/01/2001 OR U 05/15/2001 Information has been received from a RN concerning 12-16 day care center children, 1-5 years of age who in the last 3 weeks have developed mild cases of what may be chicken pox. The nurse believed at least some of these children have been vaccinated with varicella virus vaccine live at an earlier date. Additional information has been requested. U UNK UNK UNK UNK WAES00122221 1
0171965 06/01/2001 MN 1.9 1 1 M 05/15/2001 Post vax on 12/27/2000, the patient had diffuse vesicles typical of varicella. The LPN reported that they suspected "wild given the timing". In the original report the nurse reported the patient presented with a mild case of chicken pox on 12/29/2000. A culture of the lesion was sent for typing, but the results were not available. Additional information has been requested. Per F/U 6/17/02: Info has been received from an LPN concerning a 23 month old Caucasian male pt with no known allergies and a history of bronhciolitis, who on 12/20/00 was vaccinated with a 1st dose of varicella (635063/1147K) SC in the right thigh. Concomitant vaccination on 12/20/00 included a 1st dose of MMRII (636975/1281K) SC in the left thigh. There was no illness noted at the time of vaccination. Subsequently, on 12/27/00, the pt had diffuse vesicles typical of varicella. The LPN reported that they suspected "wild given the timing". In the original report, the nurse reported the pt presented with a mild case of chicken pox on 12/29/00. F/U indicated that the viral agent was not isolated from the pt's varicella lesion that was cultured. It was reported that the pt subsequently, recovered. No further info is available. Y Y 12/20/2000 12/27/2000 7 culture of lesion sent for typing; F/U 6/17/02: the viral agent was not isolated from the pt's varicella lesion PVT OTH NONE per F/U 6/17/02 Bronchiolitis WAES01010009 1
0171966 06/01/2001 HI 25.0 25 F 05/15/2001 On 11/21/2000 the patient had a negative varicella zoster antibody titer. At the time of the report, the patient had seroconverted. Additional information is not expected. Y N 09/22/2000 Serum varicella zoster - negative UNK UNK UNK UNK WAES01010022 1
0171967 06/01/2001 U 05/15/2001 Information has been received by the CDC concerning 16 patients at one daycare who were each vaccinated with one dose of varicella virus vaccine live. Subsequently, the patients experienced breakthrough varicella. In the building, there were 78 full time students with 74 of the children greater than 12 months of age. Of these 74 children, 58 had no history of chickenpox, and 16 had a history of chickenpox. Of the 58 children with no history of chickenpox, 42 had previously been vaccinated with varicella virus vaccine live, 1 was vaccinated with varicella virus vaccine live during the outbreak, and 15 had no vaccination with varicella vaccine live. Of the 42 vaccinated children, 16 developed breakthrough varicella. 14 of the cases were mild and defined as less than 50 lesions., and 2 cases were moderate and defined as 50-500 lesions. The remaining 16 vaccinated children did not experience a breakthrough rash. Of the 15 unvaccinated children, 8 developed natural varicella; 2 mild cases, 5 moderate cases and 1 severe case defined as greater than 500 lesions, and 7 had no rash (all of the 7 children were offered serologic testing of which 4 agreed, and they were all seronegative. Of the 74 children in the building, 46 attended preschool or pre-K continuously. Of the 46, 31 had no history of chickenpox, and 15 had a history of chickenpox. Of the 31 children with no history of chickenpox, 24 were vaccinated and 7 were not vaccinated. Of the 24 vaccinated, 12 developed breakthrough varicella and 12 did not have any rash. Of the seven unvaccinated children, six developed varicella and 1 was without rash. One patient in the group of students was the index case who developed a mild case of chickenpox following exposure to his sister who had herpes zoster. No further information is available. Per F/U 6/17/02: The 1st reported case had a rash onset date of 12/1/00 and the last reported date of rash onset was 1/11/01. No complications were reported during the outbreak. The median age of the case was 4 years (range 1-6), 76% were male. No cases occurred among infants less than 12 months of age (n-4) and none occurred in a child who had a prior history of varicella disease. One pt at the daycare developed herpes zoster during the outbreak (WAES 91072736). F/U info from a poster session titled "Low Varicella Vaccine Effectiveness in a Daycare Center Outbreak, New Hampshire. 12/00-2/01" was received. The report indicated that "95 (100%) parent and 94 (99%) provider questionnaires were returned. The median age of the 76 (80%) children who attended continously was 4.2 years (range: 6 months-8 years); 76% were male. Vaccination coverage was 76% of 23 cases of varicella, 15 (65%) occurred in vaccinated children and 8 (35%) occurred in unvaccinated children. The index case was a 4 year old vaccinee who developed BT on 12/1/00. The median age of cases was 4.4 years (range 1-7), VZV was cultured in 1 case and identified by PCR in another. Vaccine effectiveness was 40.5% (95% CI:-7.2; 67) overall and 41.7% in the building where the outbreak was centered. Reported on 04/11/2003: "Follow-up information reported in a published article, title stated above that the vaccination coverage among children old enough to be eligible was 49 out of 67 children. Lot numbers were verified for 46 out of 49 children. The children were vaccinated during 1996 to 2000 with at least 33 different lots of vaccine administered by 28 different health care providers. There was no evidence that any child had received expired vaccine. There was a total of 25 cases of varicella with 17 cases having occurred in vaccinated children. There were no cases in children with a history of varicella disease. Of the 25 cases of varicella, 17 were mild and 8 were moderate or severe. No child had a severe complication of varicella or required hospitalization. As compared with unvaccinated children, whose who had been vaccinated had milder disease, had new lesions on fewer days, had rash that crusted more quickly, missed frewer days of day care, and were less likely to have fever. In this outbreak, the effectiveness of varicella vaccine was 44 percent against diseases of any severity and 86 percent against moderate to severe disease. An increased risk of vaccine failure was found among children who were vaccinated three or more years previous. It was reported in an editorial that the varicella vaccine has proved to be exremely well tolerated with no serious safety issues emerging. The "breakthrough" varicella may develop in 10 to 15 percent of the vaccinated population. A copy of the published article is attached as further documentation of the patient's experience. U 12/07/2000 OTH OTH UNK UNK UNK WAES01010074 1
0171968 06/01/2001 LA 2.0 1 .2 F 05/15/2001 On 12/25/2000 the patient experienced blisters, fever, cough, runny nose and congestion. On 12/28/2000 the patient was seen in her physician's office for varicella. In follow up, the physician reported that the patient developed chicken pox on 12/28/2000, and described the appearance as an "attenuative form of pox". The patient was treated with cephalexin and acyclovir. The patient recovered. No further information is expected. Y Y 07/21/1999 12/25/2000 523 PUB OTH UNK UNK WAES01010094 1
0171969 06/01/2001 OH 2.0 2 .0 F 05/15/2001 Information has been received concerning a 5 year old white female who on 05/28/97 was vaccinated with varicella virus vaccine. On 12/26/2000, the patient developed chicken pox. FOLLOW-UP infornation received from the physician's office indicated that the patient transferred out of their office on 05/11/00. Additional infection is not expected. U 05/28/1997 12/26/2000 1308 OTH OTH UNK NKA WAES01010165 1
0171970 06/01/2001 OH 6.0 2 .7 M 05/15/2001 On 12/26/2000 the patient developed a chicken pox rash. Additional information has been requested. F/U 6/17/02: Info has been received concerning a 6 year old white male with an allergy to milk and eggs (before age 2) who on 2/19/97 was vaccinated with varicella vaccine live. On 12/26/00, the pt developed a chicken pox rash. F/U info received from the physician indicated that she had not seen the pt since 1/98, at which time his family was moving. The physician also reported that they had no records regarding any difficulty with the varicella virus vaccination that was given on 2/19/97. Additional information is not expected. U 02/19/1997 12/26/2000 1406 PVT OTH UNK Milk and egg Allergy, food allergy WAES01010167 1
0171971 06/01/2001 8.0 F 05/15/2001 In approximately October 2000, the patient experienced a mild rash on her abdomen. Unspecified medical attention was sought. It was reported that the patient's brother had a similar experience following exposure to varicella virus vaccine live. Additional information has been requested. Y U OTH OTH UNK UNK WAES01010195 1
0171972 06/01/2001 NJ 5.0 M 05/15/2001 In 1997 the patient developed modified varicella. On 01/02/2001 the patient developed a second breakthrough rash of approximately 35 pustules and was confirmed to have chickenpox. The patient sought unspecified medical attention. The patient was not on steroids, and had no history of steroid use or asthma. Additional information has been requested. Y U OTH OTH UNK UNK WAES01010215 1
0172040 06/01/2001 WA 3.0 M 05/15/2001 Post vax, the patient experienced a mild case of chicken pox. Unspecified medical attention was sought for the child. Y U UNK UNK UNK Asthma WAES01010234 1
0172041 06/01/2001 NJ 6.0 1 .5 M 05/15/2001 On 12/19/2000 the patient experienced chicken pox with 5 to 100 insect like bite like lesions, pink with different sizes, an itchy rash and no fever. Subsequently, the patient's symptoms had resolved. Unspecified medical attention was sought. No further information is expected. Y Y 07/19/1995 12/19/2000 1980 PVT PVT UNK UNK WAES01010241 1
0172042 06/01/2001 NJ 2.0 1 .0 F 05/15/2001 On 12/28/2000 the patient experienced chicken pox that included a mild papular rash, 7 lesions on her left side and arm and no fever. Subsequently, the patient recovered. Unspecified medical attention was sought. Additional information is not expected. Y Y 08/04/1999 12/28/2000 512 PVT PVT UNK WAES01010247 1
0172043 06/01/2001 GA 4.0 1 .1 M 05/15/2001 On 12/27/2000 the patient presented to the physician's office with 10-12 vesicles on his body. Subsequently, on 01/02/2001 the patient recovered. Additional information is not expected. Per F/U 6/17/02: There were no known allergies and no past medical history. The pt was vaccinated SC with a 1st dose of varicella. On 12/27/00, the pt "came down with chickenpox". Subsequently, on 1/2/01, the pt recovered. Additional info is not expected. Y Y 09/26/1997 12/27/2000 1188 PVT PVT UNK NONE NONE WAES01010297 1
0172044 06/01/2001 MA 44.0 F 05/15/2001 Post vax the patient failed to seroconvert. The patient sought unspecified medical attention. Additional information has been requested. Y U Serum varicella zoster - failed to seroconvert OTH OTH UNK UNK WAES01010358 1
0172045 06/01/2001 NJ 35.0 F 05/15/2001 The patient is in her first trimester of prenancy. On 01/01/2001 the patient developed a rash after her child was vaccinated with varicella virus vaccine live. The rash was described as vesicles with 150 to 200 lesions total which started on the chest and spread throughout the trunk, the patient had lesions from head to ankles. The patient had a fever of 103F, chills and felt tired. Subsequently the patient recovered. It was noted that the patient's child experienced an adverse event after the vaccination. No additional information is available. Y Y 01/01/2001 DNA - VZV positive wild type OTH OTH UNK Pregnancy WAES01010372 1
0172046 06/01/2001 NJ 1.25 F 05/15/2001 Two weeks post vaccination, on approximately 12/08/2000, the patient developed a mild rash which was described as a mild case of chicken pox by the physician and also a generalized skin rash with no lesions, by the nurse. The rash lasted 24 hours and it was noted that there were no remaining specimens for testing. The patient sought unspecified medical attention. The child's mother also had an experience following exposure to varicella virus vaccine live. Additional information is not expected. Y U 11/28/2000 12/08/2000 10 UNK UNK NONE UNK WAES01010450 1
0172047 06/01/2001 32.0 M 05/15/2001 In 1985 and 1986 the patient was vaccinated with an experimental chicken pox vaccine from Germany that had painful injections. In approximately 1995 the patient was vaccinated with two series of varicella virus vaccine live. Subsequently, the patient experienced no immunity to varicella virus vaccine live. Additional information has been requested. This patient also experienced a lack of response while in therapy with measles virus vaccine live, mumps virus vaccine live and rubella virus vaccine live. Y U Serum varicella zoster - no immunity to Varivax UNK UNK UNK Allergy, asthma, dust allergy, pollen allergy, ragweed allergy WAES01010481 1
0172048 06/01/2001 TX 6.0 1 .4 M 05/15/2001 Post vax, the visiting nurse reported that the patient's mother left a message reporting that her son had "chicken pox". The nurse reported that no details about the rash were given by the mother. In follow up, the patient's physician reported that the patient developed "chickenpox" in January 2001. No further information is available. Y U 08/13/1995 PVT PVT UNK UNK WAES01010593 1
0172050 06/01/2001 MN 9.0 4 F 05/15/2001 On 12/14/2000 the patient developed herpes zoster with lesions on the left costal border and 2 small vesicles on the back. The patient was seen in the ER and was treated with Acyclovir for five days. No further treatment was required. Follow up states the pain was rated a "2" with no other symptoms. The patient had no history of chicken pox or recent exposure to herpes zoster. On 01/21/2001 the patient recovered. Y Y 03/28/1996 12/14/2000 1722 OTH OTH UNK Penicillin allergy WAES01010623 1
0172051 06/01/2001 NY 27.0 27 F 05/15/2001 On 01/03/2001 the patient experienced 3 lesions on her face, 1 on her ankle and 1 on her arm. She was seen in employee health on 01/08/2001 for evaluation. The patient had no fever and the lesions were dry, scabbed and very small. The lesions were not filled with fluid. The patient recovered on 01/09/2001. Additional information is not expected. Y Y 12/22/2000 01/03/2001 12 UNK UNK Ortho-novum UNK WAES01010630 1
0172052 06/01/2001 U 05/15/2001 Post vax, the patient developed varicella. Subsequently, the patient recovered. Unspecified medical attention was sought. Y 02/09/1996 UNK UNK UNK UNK WAES01010755 1
0172053 06/01/2001 NY 0.5 F 05/15/2001 Two weeks after the patient's sibling received varicella virus vaccine live, in approximately January 2001, the patient had a "classic presentation of chicken pox". The patient presented to the physician's assistant with 15 to 20 classic chicken pox type lesions and was diagnosed with chicken pox. On 01/10/2001 the patient had approximately 100 lesions. The patient had no contact with wild type varicella virus. In follow up the patient recovered completely and has no active lesions or scabs remaining. No additional information is expected. Y Y OTH OTH UNK NONE WAES01010813 1
0172054 06/01/2001 OH 4.0 M 05/15/2001 On 01/08/2001 the patient developed a "rash like chicken pox" on his legs and back. The school nurse reports that many children in the school currently have Varicella. The patient's brother had a similar experience following exposure to varicella virus vaccine live. Follow up has been received from a physician who reports the patient information given is not enough for him to identify the patient. No further information is expected. U 01/08/2001 UNK UNK UNK Varicella exposure ~Varicella (Varivax)~~3.00~In Sibling WAES01010840 1
0172055 06/01/2001 NY 1.4 1 .0 F 05/15/2001 On 01/09/2001 the patient was found to have herpes zoster. The vesicular lesions were distributed on the left side buttocks, down the left leg to the left toe in a dermatome pattern. Approximately 50 lesions were noted. Additional information has been requested. Per F/U 6/17/02: Information has been received from a physician concerning a 17 month old female pt with no known allergies and past medical history of hyperbilirubinemia and hypoglycemia, who on 8/1/00, was vaccinated with 1 dose of varicella. There was no concomitant medication. It was reported that within a 2 week, post vax period, the pt had "some fever, but no rash". On 1/9/01, the pt was found to have herpes zoster. The rash was reported to have lasted 2-3 weeks. The physician noted that the pt was a healthy female without any known immunosuppression and without any known exposure to wild-type virus. Preliminary results indicated that the specimen, which was from a vesicular lesion/scab crust, for this case was VZV positive. Additional info indicated that the vesicular specimen was VZV positive and the presence of Oka/vaccine VZV had been identified using PCR analysis. It was reported that the pt recovered completely from that episode. Upon F/U; it was reported that on 7/3/01, the pt developed a rash "first on back, also on face, chest, legs, etc., first as red bumps (then becoming vesicular". There were new lesions identified on 7/4/01, 7/5/01 and the physician questioned the presence of new lesions on 7/6/01, when he also noted that the "old" lesions were fading and again on 7/7/01. There were no other symptoms reported. The physician stated that the rash resembles possibly breakthrough varicella. There was no recognized exposure to chicken pox or shingles. Upon physician exam, the physician reported 40 scattered lesions, mostly papular, some micro-vesicular. There were no lesions identified on the mucous membranes. This was noted to be a possible immune deficiency. However, he indicated that if specimens reveal VZV, the pt might need an immune work-up. It was reported that "no treatment (was) necessary". On 12/17/01, it was reported that the possible breakthrough rash swab specimen, collected for PCR analysis, was inadequate to process. The specimen was negative for direct fluorescent antibody. There were reported to be the final results. Addtionla info has been requested. Y Y 08/01/2000 01/09/2001 161 DNA - VZV positive and the presence of Oka/Vaccine VZV identified using PCR analysis; per F/U 6/17/02: on 7/7/01-direct flourescent antibody test-neg; 7/7/01-deoxyribonucleic acid-inadequate specimen OTH OTH NONE Per F/U 6/17/02: Hyperbilirubinemia; hypoglycemia NOS WAES01010860 1
0172056 06/01/2001 IL 1.2 F 05/15/2001 Post vax, the patient developed swollen lymph nodes. Unspecified lab tests were performed and were reported abnormal which led the physician to consider a diagnosis of leukemia. Follow up information was received from the patient's physician who indicated that the patient is normal, and the mother "overreacted". The patient was seen by a specialist and does not have leukemia. All issues around this patient's health have been resolved and the patient is healthy. Additional information is not expected. Y Y 09/15/2000 Unspecified lab tests were abnormal OTH OTH UNK WAES01010931 1
0172058 06/01/2001 IA U 05/15/2001 Information has been received from a registered nurse concerning 2 children who were vaccinated with varicella virus vaccine live. Subsequently, the patients recently developed chicken pox. Unspecified medical attention was sought. It was reported that other patients had similar experiences following exposure to varicella virus vaccine live. Additional information has been requested. Y U UNK UNK UNK UNK WAES01010941 1
0172059 06/01/2001 IA U 05/15/2001 Information has been received from a RN concerning a "few" patients who were vaccinated with varicella virus vaccine live. Subsequently, the patients developed chicken pox. Unspecified medical attention was sought. It was reported that other patients had similar experiences following exposure to varicella virus vaccine live. Additional information has been requested. Y U UNK UNK UNK UNK WAES01010942 1
0172061 06/01/2001 NJ 4.0 1 .0 M 05/15/2001 On 01/08/2001 the patient developed 20 to 30 "insect bite like" raised lesions on his face, arms and abdomen. Also noted, the patient's mother had chicken pox 12/22/2000 or 12/26/2000. The patient sought unspecified medical attention. On an unspecified date the patient recovered. No further information is expected. Y Y 04/14/1997 01/08/2001 1365 PVT PVT Amoxil, Rondec DM Otitis media, sinusitis, varicella exposure WAES01010990 1
0172062 06/01/2001 IN 7.0 M 05/15/2001 On 12/29/2000 the patient developed chicken pox that included 50-100 vesicular lesions distributed across his chest, back and extremities. Unspecified medical attention was sought. Additional information has been requested. Y U 08/20/1999 12/29/2000 497 UNK UNK UNK UNK WAES01010999 1
0172063 06/01/2001 CA 1.08 1 .1 M 05/15/2001 On 01/05/2001 the patient developed an infection, which was treated with Suprax. On 01/09/2001, the patient began to lose his appetite. The physician reported in follow up, the patient experienced "anorexia, mild-moderate for 4 days." On 01/09/2001 the patient began vomiting, 2 to 4 times a day for 4 days. On 01/09/2001 the patient was also running a fever of 101.5F. The patient also had diarrhea, which the physician described as "loose watery non-bloody, non-mucoid stools 3 to 4 times per day for 4 days. On 01/14/2001 the patient recovered from his experience. The patient's physician stated, "possible that the symptoms were antibiotic related". No further information is expected. Y Y 01/04/2001 01/05/2001 1 UNK UNK Suprax, Cefzil Otic infection, otic tube insertion, drug reaction WAES01011019 1
0172064 06/01/2001 3.0 M 05/15/2001 The patient's grandmother reported that the patient "may possibly have chicken pox now". On 01/10/2001 the patient had one spot that erupted . The physician has not seen the patient for a diagnosis. The school nurse reported that many of the children in the school currently have varicella. The patient's brother had a similar experience following exposure to varicella virus vaccine live. U 01/10/2000 UNK UNK UNK Varicella exposure rash varicelliform~Varicella (Varivax)~~4.00~Sibling WAES01011051 1
0172065 06/01/2001 ID 1.4 1 .0 F 05/15/2001 On 01/10/2001 the patient presented with vesicles consistent with herpes zoster on her left leg and lower back. The physician sent off for a culture and analysis. The culture came back positive for varicella virus. In follow up, the physician describes the herpes zoster at the injection site, down the left leg, on the left thigh and back. The patient was irritable. Additional information has been requested. Per F/U 6/17/02: The physician describes a previously healthy child without any known immunosuppression, that does not attend daycare and is not known to have inu tero or pre-varivax vaccination exposure to chickenpox. F/U indicated that the physician reported that the pt had recovered completely from her experience and that she actually had not returned for subsequent follow-up visits. Additional information has been requested. Y U 08/03/2000 01/10/2001 160 diagnostic lab - culture positive for varicella virus OTH OTH UNK NONE WAES01011122 1
0172066 06/01/2001 2.0 2 .1 F 05/15/2001 Post vax, the patient experienced varicella. The patient was treated with Augmentin. Y U 04/01/1997 UNK OTH UNK UNK WAES01011127 1
0172067 06/01/2001 NE U 05/15/2001 Information has been received from a health professional concerning 3 to 4 patients who were vaccinated with one dose of varicella virus vaccine life. It was reported on 01/15/2001 that the patients developed varicella in the past few months. The cases have been as long as 2 to 3 years after vaccination. The patients sought unspecified medical attention. Additional information has been requested. Y U OTH OTH UNK UNK WAES01011224 1
0172068 06/01/2001 MI 6.0 1 .8 F 05/15/2001 On approximately 01/15/2001 the patient developed full blown chicken pox with more than 50 lesions covering her arms, hands, lips, mouth, under eyes, legs and stomach. Also noted, the patient had a low grade fever of 101F. The patient was treated with Benadryl and Tylenol on 01/15/2001 for the itching. Additional information has been requested. Y U 07/25/1996 01/15/2001 1635 OTH OTH UNK Allergy WAES01011245 1
0172069 06/01/2001 OK 3.0 M 05/15/2001 On 12/21/1999 the patient developed a multidermal herpes zoster on his thigh. The symptoms consisted of approximately 100 papulovesicular lesions and lasted for 4 weeks. The patient was treated with Acyclovir and recovered. Additional information has been requested. Y Y 02/05/1998 12/21/1999 684 DNA - VZV for OKA strain positive OTH OTH UNK Infection WAES01011278 1
0172070 06/01/2001 TX 1.6 1 .0 F 05/15/2001 On 01/16/2001 the patient developed approximately 20 to 25 lesions, mostly erythematous papules with 2 to 3 clear vesicles and one excavated, throughout the body especially on her trunk with 2 to 3 on her labia with 1 spot scabbed over. The patient was treated with Benadryl as needed for the itch. It was noted that the patient was exposed to chicken pox on 01/02/2001 through 01/05/2001. Additional information has been requested. Y U 06/27/2000 01/16/2001 203 OTH OTH UNK Varicella exposure WAES01011345 1
0172071 06/01/2001 PA 3.0 1 .0 F 05/15/2001 On 01/14/2001 the patient developed symptoms of varicella. The patient developed a rash on her face which then spread over her trunk, lasted 1 day with 10 spots altogether. On 01/16/2001 the patient was seen in a doctor's office and was diagnosed with varicella, with approximately 25 lesions on her body. It was noted that the patient recovered. No further information is expected. Y Y 07/27/1998 PVT PVT NONE NONE WAES01011366 1
0172072 06/01/2001 MA 1.0 1 .0 F 05/15/2001 On 12/10/2000 the patient developed a rash and on 12/14/2000 was seen by her pediatrician for 30 to 40 lesions on her trunk, papules only, no vesicles. The physician did not feel it was varicella and sent specimens to the lab. On 01/23/2001 the final PCR results were negative for VZV. The patient recovered from the symptoms. Additional information has been requested. Y Y 11/16/2000 12/10/2000 24 DNA - varicella negative on 01/18/2001, Urine culture- positive varicella on 12/14/2000, urine culture - CMV NR on 12/14/2000 OTH OTH UNK Failure to thrive, hypolipoproteinemia WAES01011417 1
0172073 06/01/2001 DE 4.0 F 05/15/2001 On 01/17/2001 the nurse reported that she thought the patient had chicken pox with lesions on the patient's face and a runny nose. The patient had not felt well on 01/16/2001. The patient sought unspecified medical attention. The reported noted that the problem resolved and that the patient did not have chicken pox. Additional information has been requested. Y Y 01/16/2001 OTH OTH UNK UNK WAES01011421 1
0172074 06/01/2001 PA 4.0 4 F 05/15/2001 On 01/04/2001 the patient developed a fever and henoch-schonlein purpura which was described as a fever, bilateral leg bruising and swollen ankles. The patient sought unspecified medical attention. On an unspecified date the patient recovered. No further information is expected. Y Y 01/04/2001 01/04/2001 0 PVT PVT NONE NONE WAES01011425 1
0172075 06/01/2001 WI 6.0 4 F 05/15/2001 On 01/03/2001 the patient's sister was diagnosed with shingles. The sister was never vaccinated. Eight days later the patient developed a fever. On 01/13/2001 the patient developed blisters and a bloody ear. The patient was seen in the ER and had blisters in her ear canal. The patient was diagnosed with chicken pox. Approximately 7 to 10 days later the patient recovered. The hospital summary was not available. No further information is expected. Y Y 03/10/1999 01/11/2001 673 UNK UNK UNK Otic infection Herpes zoster exposure WAES01011449 1
0172076 06/01/2001 CA 1.5 2 .5 M 05/15/2001 On 01/11/2001 the patient developed chicken pox that consisted of a few lesions and resolved in 5 to 7 days. Unspecified medical attention was sought. No further information is expected. Y Y 01/01/1997 01/11/2001 1471 UNK UNK Rhinocort, Flovent, Singulair Asthma, cat allergy, dust allergy, pollen allergy WAES01011466 1
0172077 06/01/2001 KY 1.3 M 05/15/2001 On 01/17/2001 the patient presented to the physician's office, and Infectious Disease practice, with Herpes Zoster on the left arm. To the nurses' knowledge, the patient was a normal, healthy child, with no history of recent varicella exposure, including no in utero exposure, and no known immunosuppression. The nurse noted that the lesions extended from the left shoulder area down his arm towards the fingers. Additionally, the child has itching and fussiness. Information from the VZV ID program stated that the final PCR results for the vesicular specimen was positive for OKA vaccine strain VZV. Additional information has been requested. Y U 01/17/2001 DNA - VZV positive-vaccine type OKA strain UNK UNK UNK NONE WAES01011660 1
0172078 06/01/2001 PA 3.0 1 .0 M 05/15/2001 Post vax, the patient reported to the physician's office with "chickenpox over his belly and trunk with some spread to the extremities". The LPN reported that the patient had approximately 100 lesions, non-pustular in nature, and that the patient complained that they were very itchy. In follow-up, the LPN reported that on 01/16/2001, the patient had the rash all over, more than 40 small raised rash all over, itchy. The patient recovered in 3 days. No further information is available. Y Y 09/17/1998 01/16/2001 852 UNK UNK UNK UNK WAES01011713 1
0172079 06/01/2001 PA 10.0 F 05/15/2001 Information has been received from a physician concerning a patient who "many years ago" was vaccinated with varicella virus vaccine live. On approximately 01/11/2001 the patient experienced chicken pox. Additional information has been requested. U 01/11/2001 UNK UNK UNK UNK WAES01011740 1
0172080 06/01/2001 MS 1.4 1 .4 F 05/15/2001 Information has been received from a health profesainal concerning a 4 year old Caucasina female with penicillin allergy who on 08/01/97 at 2:15 pm was vaccinated with a first dose of Varivax in the right thigh. Concomitant therapy included then fourth dose of alum, potassium tripedia in the left thigh and a third dose of OPV. On 01/18/2001, the patient developed a rash of 5 to 6 little spots for 3 to 4 days. The patient's mother thought it may be chicken pox. The patient was scheduled to see the doctor on 01/19/2001, and was treated with Benadryl and recovered. It was also noted that the patient was exposed to chicken pox at daycare. No further information is available. Y Y 08/01/1997 01/18/2001 1266 OTH OTH Penicillin allergy, varicella exposure WAES01011741 1
0172081 06/01/2001 NY 9.0 5 F 05/15/2001 Information has been received from a health professional concerning a patient was vaccinated with one dose of vaccine. The patient was titered on 01/17/2001 and showed failure to seroconvert. The patient sought unspecified medical attention. Addiitonal information has been requested. Y U 07/05/1996 01/17/2001 1657 Serum varicella zoster - negative OTH OTH UNK UNK WAES01011752 1
0172082 06/01/2001 WI 29.0 29 F 05/15/2001 The patient experienced itchiness around the injection site and on 01/17/2001 developed 10 lesions over the entire body. The patient sought unspecified medical attention. Additional information has been requested. Per F/U 6/17/02: The pt has a novacaine allergy, irregular menses and keratitis and a history of dry skin, tendinitis and lipoma. On 1/2/01, the pt was vaccinated with the 1st dose of varicella (0.5ml) (lot 635490/1142K) in the left deltoid, IM. Concomitant therapy included 1 dose of DPT in the right deltoid, IM (0.5ml) (lot 343AA) and unspecified eye drops for keratitis and prenatal vitamins. On 1/4/01, the pt reported at 16:10, right arm tender, no increasing warmth but increasing redness around the injection site of 1". Pt also reported that she thought she had a low-grade temperature. The pt was instructed to use ice packs. On 1/17/01, the pt broke out in about 10 lesions all over her body, they were "pinhead to grapefruit size", very itchy and no drainage noted. The pt called the physician's office on 1/18/01 and noted she was afebrile until "today" (temp of 99.1F). The pt was told to use OTC Benadryl as instructed. It was noted on 1/20/01 that the symptoms "sounds like chickenpox". It was also reported that on 1/25/00, the pt was tested for varicella, IgG titer was absent. On the day of vaccination, the pt was given a urine pregnancy test which was negative. Her last menstrual period was some 6 weeks prior; the pt was typically late. Additional info has been requested. Y U 01/04/2001 01/17/2001 13 10/25/00-serum varicella zoster-neg; 1/18/01-temp-99.3F; urine beta-human-neg; 1/2/01-BP 106/7?; PR-88 PVT PVT Vitamins; unspecified eye drops for keratitis Keratitis Dry eyes, dry skin, lipoma NOS, tendonitis, drug hypersensitivity; menstruation irregular; keratitis NOS WAES01011770 1
0172083 06/01/2001 GA 18.0 18 F 05/15/2001 On 01/17/2001, in the evening, the patient developed a very mild rash, maybe 8 lesions, that appeared to be chickenpox. The patient sought medical attention. Additional information has been requested. Y U 01/02/2001 01/17/2001 15 OTH OTH UNK Amoxicillin allergy, cephalexin allergy, codeine allergy, drug allergy, meperidine allergy, sulfonamide allergy WAES01011825 1
0172084 06/01/2001 FL 1.0 F 05/15/2001 On 02/22/2000 the patient experienced a very high fever. Follow-up was received from a physician. She was seen in the physician's office 02/22/2000. The patient experienced 2 red papules "that did not appear to be chicken pox", a runny nose and a fever of 103F. She was diagnosed with cold symptoms. On 02/24/2000 the patient was diagnosed with chicken pox, which the physician felt had been modified by the administration of the vaccine. At this point, the patient's mother also had chickenpox. This was considered a case of secondary transmission. Because both the mother and the child developed chickenpox at the same time, the physician felt they must have both been exposed to the same source of wild type virus and that the child's chickenpox had been modified because of the vaccine. The mother was pregnant at the time. In July of 2000, the patient was seen in the physician's office for an 18 month visit. The mother and her baby were noted to have adverse events. No further information is available. Y U 01/20/2000 02/22/2000 33 UNK UNK NONE UNK WAES01011852 1
0172085 06/01/2001 PA 7.0 7 F 05/15/2001 On 01/17/2001 the patient developed the "worst case" of chicken pox that the physician had ever seen in an immunized child. The child had pox all over her face, trunk, arms, legs, scalp and mucous membrane. The patient was treated with Benadryl. Additional information has been requested. Y Y 06/09/1995 01/17/2001 2049 PVT PVT UNK UNK WAES01011862 1
0172086 06/01/2001 HI F 05/15/2001 Information has been received from a physician concerning a female patient who was vaccinated on an unspecified date with the first dose of vaccine. There was no concomitant medication. The patient did not seroconvert after receiving a first vaccination. A second dose of vaccine was administered and again the patient did not seroconvert. The patient sought unspecified medical attention. Additional information has been requested. Y U Serum varicella zoster - negative OTH OTH NONE UNK WAES01011875 1
0172087 06/01/2001 CO 7.0 F 05/15/2001 The patient developed a rash of about 20 'spots' on the day after being vaccinated, reported by the health care professional on 12/11/2000. The parents of the patient have called weekly reporting that the rash returns weekly since vaccination and resolves each time within 3 days. It was suggested the patient be taken to see her primary care physician. The patient did not have a rash at the time of the visit. On 02/08/2001 the mother stated that the child continued to have intermittent rashes of 1 to 5 spots that appeared like "chicken pox". The spots go away quickly but are raised blister like spots that itch. The patient has no other history of reactions or health problems. On 02/22/2001 the nurse reported the patient continues to break out every 7 to 14 days with 5 to 10 lesions that resolve several days later. Additional information has been requested. Y N 12/11/2000 12/11/2000 0 PUB PUB NONE NONE WAES01011967 1
0172088 06/01/2001 MA 6.0 6 F 05/15/2001 On 01/18/2001 the patient developed chicken pox with symptoms of rash, fever, pruritis and lesions over the whole body. The patient had an extremely itchy rash. Also noted, the number of lesions were undetermined by the the reporter. The symptoms lasted for 5 days. The patient was treated with Atarax and Aveeno Bath and recovered. The patient sought unspecified medical attention. Additional information has been requested. Y Y 07/11/1996 01/18/2001 1652 PVT PUB Allergenic extract Allergic rhinitis, mite allergy, mold allergy WAES01012001 1
0172089 06/01/2001 VT 16.0 16 F 05/15/2001 The patient received in February 1997 and April 1997 the first and second doses of varicella virus vaccine live. It was reported on 01/22/2001 that a recent titer showed negative antibodies. The patient sought unspecified medical attention. Additional information has been requested. Y U 04/01/1997 01/01/2001 1371 Serum varicella zoster - negative OTH OTH UNK UNK WAES01012015 1
0172090 06/01/2001 VA 1.0 1 .1 M 05/15/2001 On 01/14/2001 the child developed a rash, described as huge raised welts. The rash was blotchy and itchy. The rash spread to the patient's chest, back, anus and ankles. The physician described the rash as erythema multiform. The child was given Benadryl and Aveeno Baths. The child was sleeping a lot, had no fever, and no respiratory problems. No further details were provided. Additional information has been requested. Y U 01/12/2001 01/14/2001 2 OTH OTH NONE seizure WAES01012082 1
0172091 06/01/2001 1.0 M 05/15/2001 The patient developed a small mark after the injection which expanded to one and a half inches after one week. The patient sought unspecified medical attention. Additional information has been requested. Y U OTH OTH UNK UNK WAES01012172 1
0172092 06/01/2001 VA 1.0 1 .0 M 05/15/2001 On 04/01/2000, post vaccination, the patient developed a 1cm by 2 cm red dermal nodule that was fairly soft superficially, but indurated deeper in the dermis of the vaccination site. The nodule was present for 5 months and resolved to a flat scar, still indurated like a "dermato fibroma" within 1 month of treatment with Topicort Cream. Additional information is not expected. Per F/U 6/17/02: Information has been received from a physician concerning a 12 month old white male, with no pre-existing allergies, birth defects or medical conditions and no illness at the time of vaccination on 3/31/00 with a 1st dose of varicella (lot 631475/1003J) in the thigh. Concomitant vaccination the same day, included the 1st dose of MMRII (lot 632236/0937J) in the thigh. In 6/00, a course of cephalexin was tried and failed. In 9/00-10/00, the pt was referred to a dermatologist who treated the red nodule with Topicort Cream. It was reported that the pt (WAES00101513) had a similar experience following exposure to MMRII. Additional info is not expected. Y Y 03/31/2000 04/01/2000 1 PVT PVT NONE NONE WAES01012173 1
0172093 06/01/2001 NY 7.0 4 M 05/15/2001 On 01/19/2001 the child broke out in chicken pox. The mother reported that he had "hundreds of lesions from the top of his head to the top of his foot and that almost all the lesions were small and crusty, however 10-20 were large, sore, with scabs. The child also had a fever on 01/19/2001 and 01/20/2001. Subsequently, the patient's fever resolved. The physician reported that the child's chicken pox rash resolved on 01/30/2001. The patient sought unspecified medical attention. The reporter also reported the experiences of her daughter after vaccination with varicella virus vaccine live. Additional information is not expected. Y Y 08/03/1998 01/19/2001 900 PVT OTH NONE UNK Asthenia/fatigue~Varicella (Varivax)~~0.00~In Patient WAES01012210 1
0172094 06/01/2001 NY 1.5 1 .5 F 05/15/2001 Information has been received from a physician and a pediatric patient's mother concerning an 18 month old female who was reported to have received two doses of varicella virus vaccine live by "accident". The first dose was administered on 11/02/2000. The second dose was administered on 01/09/2001. On 01/24/2001 the patient developed herpetic stomatitis. The child's mother sought medical attention for her child because she suspected that the additional dose of varicella virus vaccine live resulted in the herpetic stomatitis. The physician inquired as to the possibility of herpetic stomatitis due to the second varicella virus vaccine live immunization. Additional information has been requested. Y U 01/09/2001 01/24/2001 15 NONE OTH OTH NONE UNK WAES01012217 1
0172095 06/01/2001 MS 2.5 2 .5 M 05/15/2001 On 01/23/2001 the patient's mother called the clinic and reported that the child "broke out with a bad case of chicken pox about 2 weeks after being exposed to it". At the time of the report, it was all over the patient's body including his mouth and he had a low grade fever. The child was seen in the clinic's office. The nurse reported on follow up that there was no adverse reaction to vaccine and that the child contacted chicken pox one year after vaccination. No further details were provided. Y N 01/01/2000 01/23/2001 388 OTH OTH UNK Varicella exposure WAES01012225 1
0172096 06/01/2001 MI 1.2 1 .1 F 05/15/2001 On 01/16/2001 the patient developed a fever, rash and decreased appetite. On 01/18/2001 the patient was presented at the doctor's office with chicken pox. The child had a fever of 100.8F and erythematous vesicular eruptions on her legs, face, trunk and lips. The vesicles of the oral mucosa were all less than 1mm in size. On 01/24/2001 the patient returned to the doctor's office. The mother of the patient stated that the rash on the face got worse. The patient was febrile, had pain with the rash, difficulty eating, lips were swollen, there were papular vesicle changes. The patient's cheeks were bright red with confluence of papular vesicular eruptions, her gums were erythematous, the soft palate had similar lesions, shotty neck nodes and the neck was supple. The nurse stated that there was a prominent rash on the patient's face and lesions are "dry, and yellow crusting" and there were new lesions on the body. The lesions were on the arms, legs and buttocks. The nurse was concerned because the patient was still breaking out in new lesions and had progressive varicella. The patient was treated with acyclovir. On 02/05/2001 the patient was much improved and had no lesions after 01/25/2001. The patient still had red areas where the lesions were but the fever was gone. No further information was provided. Y N 05/10/2000 01/16/2001 251 Throat culture - screen and culture-negative PUB OTH UNK UNK WAES01012243 1
0172097 06/01/2001 CA U 05/15/2001 Information has been received from a health professional concerning a class of 44 pre-school age children, 33 of whom were vaccinated with varicella virus vaccine live. The immunization project coordinator reported after a compliance visit to the preschool that 15 children had developed chicken pox after an 'outbreak'. It was unknown if any of the patients sought medical attention. Additional information has been requested. U UNK UNK UNK UNK WAES01012354 1
0172098 06/01/2001 GA 1.0 0 1 F 05/15/2001 On 01/22/2001 the patient developed shingles and presented to the physician's office with a discolored rash on her right arm which resembled "Varivax" A culture was done to diagnose shingles vs. contact dermatitis. The smear was positive for herpes and acyclovir was started. As of 01/26/2001 the patient was still taking acyclovir. Additional information has been requested. Y U 04/01/1999 01/22/2001 662 diagnostic microbiology-culture positive for herpes UNK UNK NONE Urinary tract infection WAES01012380 1
0172099 06/01/2001 NJ U 05/15/2001 Information has been received from a physician concerning 3 patients who were each in contact with a person who was vaccinated with one does of varicella virus vaccine live. Subsequently, these patients developed a breakthrough case which was considered direct transmission from the vaccinated persons. Additional information has been requested. U OTH OTH UNK UNK WAES01012387 1
0172100 06/01/2001 IN 1.2 1 .2 F 05/15/2001 On 12/30/2000 the patient developed 10 lesions. Subsequently the patient recovered on 01/07/2001. No further information is available. Y 08/09/2000 12/30/2000 143 PUB OTH UNK UNK WAES01012423 1
0172101 06/01/2001 IN 3.0 3 M 05/15/2001 On 01/01/2001 the patient experienced 10 to 20 lesions. Subsequently, on 01/13/2001 the patient recovered from the lesions. No further information is available. Y 05/19/1995 01/01/2001 2054 PVT OTH UNK UNK WAES01012425 1
0172102 06/01/2001 NY F 05/15/2001 On 01/16/2001 the patient had the 'chicken pox' although the reporter did not know it at the time. The patient had 2 to 3 spots on her abdomen and was feeling lethargic, although she did not have a fever. The outcome of the patient's experiences were not reported. The patient sought unspecified medical attention. The reporter also reported the experiences of her son after vaccination with varicella virus vaccine live. Additional information is not expected. U 03/01/1999 01/16/2001 687 UNK UNK NONE UNK ~Varicella (Varivax)~~7.00~In Sibling|~Varicella (Varivax)~~7.00~In Sibling WAES01012435 1
0172103 06/01/2001 CA 24.0 24 F 05/15/2001 On 04/05/1999 the patient developed a red rash on her arms, legs and stomach which was diagnosed as disseminated varicella virus infection. The patient was sent to a dermatologist on 05/10/1999. The dermatologist diagnosed acute aggravated psoriasis vulgaris treated till 07/15/1999. The patient recovered. Y Y 04/01/1999 04/05/1999 4 UNK UNK UNK Psoriasis vulgaris UNK WAES01012485 1
0172104 06/01/2001 IL 1.0 1 .0 M 05/15/2001 On 01/25/2001 the patient developed a fever of 101.8 to 101.9F. As of 01/26/2001 the patient's fever continued. Unspecified medical attention was sought. In follow-up, the physician reported that he would not consider the patient's temperature of 101.8 to 101.9F as a significant reaction or adverse event. No further information is expected. Y N 01/18/2001 01/25/2001 7 UNK UNK UNK WAES01012508 1
0172105 06/01/2001 50.0 M 05/15/2002 Information has been received from a RN concerning a 50 year old male with a codeine allergy who on 01/16/2001 was exposed to varicella virus vaccine live via secondary transmission from his one year old granddaughter who on 01/15/2001 was vaccinated subcutaneously in the upper right thigh with 0.5 milliliters of varicella virus vaccine live (lot# 636572/0929K). It was reported that the granddaughter had 'no reaction to the vaccine'. On 01/16/2001, the child urinated on her grandfather's leg and on 01/16/2001 he had developed shingles in the same area. The rash was described as a blistery and painful vesicular rash that was scattered on his right thigh. It was reported there were numerous lesions that were scabbed over. The rash was diagnosed as herpes zoster approximately 2 weeks after the rash occurred. He was afebrile. The nurse reported in a FOLLOW- UP that the grandfather was coming into his granddaughter's pediatrician's office on 02/13/01 to have a specimen collected. It was indicated that the grandfather had chicken pox at age nine, but no recent exposure to varicella or herpes zoster. It was noted that the grandfather was on no medication when the rash occurred, but it is now on an antidepressant. The grandfathewr has recovered. FOLLOW-UP information indicated that the "shingles specimen" was betaglobulin positive and the presence of wild type VZV was identified. Y N 01/16/2001 Deoxyribonucleic acid - 02/13/01 - positive wild type VZV UNK UNK UNK Varicella, codeine allergy WAES01012589 1
0172106 06/01/2001 CA 1.0 1 .1 M 05/15/2001 On 01/25/2001 the patient developed chicken pox from head to foot. Unspecified medical attention was sought. In follow up the physician reported that she felt fairly comfortable that this child's rash was probably wild-type varicella. Additional information has been requested. Y U 01/23/2001 01/25/2001 2 OTH OTH UNK UNK WAES01012607 1
0172107 06/01/2001 MI 12.0 12 F 05/15/2001 On 01/28/2001 the patient experienced a headache followed by eruptions of lesions, described by the nurse as approximately 40 vesicles on the child's arms, chest, back, face and scalp with some crusting. There was no treatment ordered. Additional information has been requested. U 01/16/2001 01/28/2001 12 OTH OTH NONE NONE WAES01012895 1
0172108 06/01/2001 CA 0.8 0 .8 F 05/15/2001 On 01/23/2001 the patient developed several itchy and painful papules. On 01/03/2001 the patient presented to her physician's office with a large crusty patch on her left side near her back. The physician indicated she had Herpes Zoster. Additional information has been requested. Y U 01/06/1998 01/23/2001 1113 UNK UNK NONE UNK WAES01012723 1
0172109 06/01/2001 PA 3.0 3 M 05/15/2001 On 01/22/2001 the patient experienced varicella rash and upper respiratory infection with a slight fever. Medical attention was sought. Prescription drug treatment was not required. On 02/01/2001 the patient recovered from varicella rash, upper respiratory infection and slight fever. No further information is available. Y Y 01/10/1997 01/22/2001 1473 UNK UNK Albuterol, Amoxicillin Asthma WAES01012778 1
0172110 06/01/2001 IA 1.0 1 .0 F 05/15/2001 On 01/21/2001 the patient experienced a fever. Subsequently on 01/27/2001 the patient developed a cough, runny nose and a vesicular rash on her trunk, arms and legs. The patient was examined by a nurse practitioner. Additional information has been requested. Y U 03/29/2000 UNK UNK Albuterol, Zithromax NONE WAES01020049 1
0172111 06/01/2001 NJ 3.0 3 M 05/15/2001 On 01/26/2001 the patient developed chicken pox. Subsequently the patient recovered. Unspecified medical attention was sought. Y Y 10/17/1995 01/26/2001 1928 NONE PVT PVT UNK Cephalexin allergy WAES01020052 1
0172112 06/01/2001 FL 42.0 F 05/15/2001 On 01/31/2001 within a few hours of vaccination the patient developed vesicles. The following day the patient developed 'many vesicles' and was seen by a nurse practitioner. Additional information has been requested. Y U 01/31/2001 01/31/2001 0 OTH OTH NONE NONE WAES01020180 1
0172113 06/01/2001 U 05/15/2001 Information has been received from a medical assistant concerning 3 children who in February 1999 were vaccinated with varicella virus vaccine live. Subsequently the children developed varicella. No further information is expected. U 02/01/1999 UNK UNK UNK UNK WAES01020202 1
0172114 06/01/2001 NJ 4.0 4 M 05/15/2001 On 01/31/2001 the patient developed chicken pox with approximately 20 lesions and a headache. Additional information has been requested. U 08/27/1995 01/31/2001 1984 OTH OTH NONE UNK WAES01020203 1
0172115 06/01/2001 NJ 1.08 1 .0 F 05/15/2001 On 01/31/2001 the patient developed chicken pox with less than 20 lesions. It was also noted, no other symptoms were present. The patient sought medical attention at a physician's office. Subsequently, the patient recovered. No further information is expected. The patient's sibling was vaccinated with varicella virus vaccine live and experienced mild varicella. Y Y 08/03/1998 01/31/2001 912 PVT PVT UNK ~Varicella (Varivax)~~1.00~In Sibling WAES01020208 1
0172116 06/01/2001 NJ 1.2 1 .1 M 05/15/2001 On 01/31/2001 the patient developed a mild case of chicken pox with less than 20 lesions. No other symptoms were present. The patient sought medical attention at a physician's office. On an unspecified date the patient recovered. It was also reported that the patient's sibling received varicella virus vaccine live and at 14 months of age, and experienced a similar adverse event. No further information is expected. Y Y 12/26/2000 01/31/2001 36 PVT PVT Bronchiolitis, myringotomy, asthma, esoptropia ~Varicella (Varivax)~~1.00~In Sibling WAES01020209 1
0172117 06/01/2001 AR M 05/15/2001 The patient developed a bad case of chicken pox and later developed a secondary infection of pox and went to the emergency room. The patient was given Keflex and Benadryl. Additional information has been requested. Y U 03/25/1998 OTH OTH NONE NONE WAES01020215 1
0172118 06/01/2001 CA F 05/15/2001 In September 1999 before her first vaccination, the patient showed a negative titer. In December 2000 the patient again showed a negative titer. The patient sought unspecified medical attention. Additional information has been requested. Y U Serum varicella zoster - negative titer OTH OTH UNK UNK WAES01020225 1
0172119 06/01/2001 VA 5.0 5 F 05/15/2001 On 02/01/2001 the patient presented with chicken pox over her entire body, 75-100 crusty lesions. The nurse practitioner reported that 'no other symptoms were noted'. Additional information has been requested. Per F/U 6/17/02: Info has been received from an NP concerning a 10 year old female with no know drug allergies who on 8/10/95 was vaccinated with a dose of varicella. Concomitant therapy included Singulair 5mg qd. On 2/1/01, the presented with "chickenpox over entire body, 75-100 lesions". There were papular lesions over her face, head, neck, trunk, arms and legs and some lesions were open and crusty, all were pruritic. The NP reported that "no other symptoms noted". Subsequently, the pt recovered. No further info is expected. Y U 08/10/1995 02/01/2001 2002 OTH OTH Singulair UNK WAES01020300 1
0172120 06/01/2001 FL 4.0 M 05/15/2001 On 01/26/2001 the patient was seen in the office and diagnosed with chicken pox. The patient presented with an itchy, maculopapular rash on the face, hands, back and stomach with a slight fever. The reporter noted that on the day of the original vaccination, the patient had received no other vaccinations. Additional information has been requested. Y U 01/26/2001 OTH OTH NONE UNK WAES01020322 1
0172121 06/01/2001 CA 4.0 3 F 05/15/2001 In approximately February 2001 the patient developed chicken pox. The reporter noted that the patient was well and had no fever. However, the patient had lesions on her lower buttocks, thighs and lower back. Additional information has been requested. U 04/12/2000 OTH OTH UNK UNK WAES01020325 1
0172122 06/01/2001 GA 7.0 12 F 05/15/2001 On 02/04/2001 the patient developed chicken pox with a fever of 101F. Additional information has been requested. FOLLOW-UP information has been received from a health professional that states the patient recovered. FOLLOW-UP information has been received from a physician who is the mother of the patient. She reported that the patient broke out with the chicken pox on 02/03/00. It was reported that she had about five pox on her face, multiple across her chest, abdomen, back and down in her vulvar area and some scattered on her arms and legs. It was reported that she would "judge to be mild to moderate case". Unspecified medical attention sought. No further information is expected. Y Y 09/21/1995 02/03/2001 1962 NONE PVT PVT NONE NONE WAES01020383 1
0172123 06/01/2001 NY 6.0 1 .3 M 05/15/2001 On 02/01/2001 the patient experienced typical chicken pox rash all over his body. The physician confirmed the rash on 02/03/2001. The rash was well over 100 pox on his trunk, face, scalp, legs and groin area. The patient was given no treatment. Follow up information has been received from a physician who reports the patient had a moderate case of varicella, approximately 100 lesions. No further information was available. Per F/U 6/17/02: Info has been received from the relative of a 6 year old Caucasian male consumer who on 1/20/96 was vaccinated with a 1st dose of varicella (lot 609263/0428B) SC, in the left arm. There was no illness at the time of vaccination. It was reported that on 1/5/96, the pt received the 1st dose of MMRII (lot 616442/1181B) SC, in the right arm and the 4th dose of Hib, IM, in the left arm. Other concomitant therapy included sodium fluoride + vitamins (unspecified) (Poly-vi-flor tablets). On 2/1/01, the pt experienced typical chickenpox rash all over his body. The physician confirmed the rash on 2/1/01. The rash was well over 100 pox on his trunk, face, scalp, legs and groin area. The "varicella resolved without incident. The pt is well." No further info is expected. Y Y 01/20/1996 02/01/2001 1839 NONE PVT PVT Poly-vi-flor tablets NONE UNK WAES01020392 1
0172124 06/01/2001 NJ M 05/15/2001 In approximately 1999 the patient was vaccinated with varicella virus vaccine live. Subsequently, recently the patient experienced pain in his chest. The patient was told by the physician that he possibly had shingles. The patient has no lesions or any marks on his skin. The wife felt that the patient had pulled a muscle. Additional information has been requested. U 01/01/1999 UNK UNK UNK UNK WAES01020512 1
0172125 06/01/2001 OR M 05/15/2001 On 01/31/2001 the patient was seen in the physician's office and had a varicella like rash with 15-20 lesions on his trunk, arms, hands and feet. The physician's assistant reported that she did not know if the patient had been exposed to 'wild type varicella'. Unspecified medical attention was sought. The physician assistant also reported on the patient's sibling who had an experience following vaccination with varicella virus vaccine live. In follow-up, the physician's assistant reported that this turned out not to be a reaction to the varicella vaccination. The child was seen 03/13/2001 and diagnosed with flea bites. This was much more consistent with the history that we eventually got from the parent and the distribution and timing and longevity of the rash. No further information is available. Y U 01/31/2001 UNK UNK UNK UNK ~Varicella (Varivax)~~1.00~In Sibling|~Varicella (Varivax)~~1.00~In Sibling WAES01020519 1
0172126 06/01/2001 TX 1.0 1 .0 F 05/15/2001 Ten days post vax, the patient experienced multiple pox lesions on her face and 2 pox lesions on her chest. Medical attention was sought. On 1/21/2001, the patient recovered. No further information is available. Y Y 01/05/2001 01/15/2001 10 UNK UNK UNK Cough UNK WAES01020584 1
0172170 06/01/2001 NY U 05/15/2001 In approximately May or June 2000, two patients had titers drawn. Both patients were seronegative for varicella immunoglobulin. Unspecified medical attention was sought. Additional information has been requested. Y U serum varicella zoster - seronegative OTH OTH UNK UNK WAES01020649 1
0172171 06/01/2001 OR 1.25 M 05/15/2001 In approximately February 2001, the patient developed lesions on the trunk, greater than 10 lesions. the physician's assistant did not know if the patient had been exposed to 'wild type varicella'. Unspecified medical attention was sought. The physician's assistant also reported on the patient's sibling who had an experience following vaccination with varicella virus vaccine live. In follow-up, the physician's assistant stated, "this turned out not to be a vaccination reaction at all. The child was seen a month later with a worse rash and was diagnosed with 'flea bites' with a secondary bacterial infection. This diagnosis is much more consistent with the history and the distribution, timing and longevity of the rash. No further information is available. Y U UNK UNK UNK UNK ~Varicella (Varivax)~~0.00~In Sibling WAES01020728 1
0172172 06/01/2001 PA 50.0 50 M 05/15/2001 On 02/05/2001 at titer was drawn that showed that the patient had failed to seroconvert. It was reported that there were no side effects. The patient does not want a third dose. No further information is available. Y U 12/05/2000 02/05/2001 62 serum varicella zoster-neg seroco PVT OTH UNK UNK WAES01020861 1
0172173 06/01/2001 FL 1.0 1 .0 M 05/15/2001 On 02/09/2001 the patient had a few lesions. In follow-up, the patient's mother called the physician's office on 02/12/2001 to report the patient had 'several spots'. The onset of the spots was 02/09/2001. Unspecified medical attention was sought. The nurse also reported on the patient's mother who had a experience following the child's vaccination with varicella virus vaccine live. Additional information has been requested. Y U 01/31/2001 02/09/2001 9 UNK UNK UNK Upper respiratory infection UNK WAES01020967 1
0172174 06/01/2001 PA 1.0 1 .0 M 05/15/2001 In February 2001 the patient developed a mild case of chicken pox. The patient had one day of fever and a few eruptions. The patient was not seen in the physician's office for symptoms. Unspecified medical attention was sought. Additional information has been requested. Y U 02/26/1997 02/01/2001 1436 OTH OTH UNK NONE WAES01020977 1
0172175 06/01/2001 TX 22.0 22 M 05/15/2001 On 02/09/2001 the patient returned to the health center with a mild case, just a few lesions, of chicken pox. It was reported that the patient was treated with acyclovir. Additional information has been requested. Y U 01/26/2001 02/09/2001 14 OTH OTH NONE Amoxicillin allergy, varicella exposure WAES01021056 1
0172176 06/01/2001 1.5 1 .6 M 05/15/2001 On 02/11/2001 the patient experienced a hives like rash. It was noted that no other symptoms were reported. Unspecified medical attention was sought. Additional information has been requested. Y U 02/06/2001 02/11/2001 5 OTH OTH NONE UNK WAES01021060 1
0172177 06/01/2001 MN 15.0 15 F 05/15/2001 Post vax, the patient developed 5 or 6 chicken pox. The patient sought medical attention. Additional information has been requested. Y U 01/09/2001 UNK UNK UNK UNK WAES01021092 1
0172178 06/01/2001 MN M 05/15/2001 Information has been received from a RN concerning many males, who were vaccinated with varicella virus vaccine live. Subsequently, the patients later had varicella. All of the children received the vaccine after one year of age and later. Unspecified medical attention was sought. Additional information has been requested. Y U UNK UNK UNK UNK WAES01021125 1
0172179 06/01/2001 MN F 05/15/2001 Information has been received from a registered nurse concerning many females, who were vaccinated with varicella virus vaccine live. Subsequently, the patients later had varicella. All of the children received the vaccine after one year of age and later. Unspecified medical attention was sought. Additional information has been requested. Y U UNK UNK UNK UNK WAES01021127 1
0172180 06/01/2001 NY 5.0 1 .3 M 05/15/2001 On 02/03/2001 the patient developed varicella. There were no illnesses at the time of vaccination. On 02/13/2001 the patient presented to the physician and was diagnosed with varicella with 10-40 vesicles. It was noted that the patient was afebrile and no treatment was ordered. The physician considered the patient's experience to be non-serious. Subsequently the patient recovered. No further information was available. Y Y 03/04/1997 02/03/2001 1432 PVT PVT NONE WAES01021186 1
0172181 06/01/2001 FL F 05/15/2001 Information has been received from a LPN concerning a female whose 12 month old son was vaccinated on 01/31/2001. On 02/09/2001 the mother had lesions and saw her physician, and was diagnosed with varicella. The nurse also reported on the patient's child who had a similar experience following vaccination with varicella virus vaccine. Additional information has been requested. Y U 02/09/2001 UNK UNK UNK UNK WAES01021205 1
0172182 06/01/2001 NY 32.0 32 F 05/15/2001 On 02/05/2001 the patient experienced sweats, diarrhea and pain. On 02/15/2001 the experienced a stiff neck. Unspecified medical attention was sought. FOLLOW-UP information has been received from a physician who reports he checked with the patient and she denies any adverse reaction to the vaccine. Y U 02/03/2001 02/05/2001 2 OTH OTH UNK UNK WAES01021264 1
0172183 06/01/2001 NJ 33.0 33 M 05/15/2001 on 02/15/2001 the patient developed a generalized rash. The patient sought unspecified medical attention. It was reported that the patient recovered from the rash. Additional information has been requested. Y Y 01/30/2001 02/15/2001 16 PVT PVT UNK UNK WAES01021283 1
0172184 06/01/2001 NY 6.0 1 .3 M 05/15/2001 Post vax, the patient developed varicella. Unspecified medical attention was sought. It was reported that the patient's sister had a similar experience following exposure to varicella virus vaccine. Additional information has been requested. F/U 6/17/02: Information has been received from a physician and consumer concerning her 6 year old Caucasian son with no known allergies, asthma and a mild developmental delay who on 9/11/95 was vaccinated with a 1st dose of varicella (lot 609280/0429B). Concomitant vaccination that same day, included a 1st dose of MMRII (lot 615325/0787R) and a 4th dose of Hib (lot 6F61149). Concomitant therapy included albuterol nebulizer qid and fluticasone propionate (Flovent) MDI BID. There was no illness at the time of vaccination. The physician reported that on 2/1/01, that pt developed breakthrough varicella and it was reported to be a mild illness. The pt sought unspecified medical attention. There was no relevant diagnostic tests and lab data. The pt subsequently recovered. The date of recovery was unknown. It was reported that the pt's sisters (WAES01021600 and 01021601) had a similar experience following exposure to varicella virus vaccine live. No further info is expected. Y Y 09/11/1995 04/01/2001 2029 NONE OTH OTH Albuterol, Flovent Asthma NOS; Developmental Delay NOS ~Varicella (Varivax)~~8.00~In Sibling|~Varicella (Varivax)~~3.00~In Sibling WAES01021370 1
0172185 06/01/2001 NJ 22.0 22 F 05/15/2001 Information has been received from a health professional concerning a 22 year old black female who on 12/27/00 was vaccinated with a first dose of Varivax. On 01/06/01,the patient experienced a "few lesions" which resolved by 01/29/01. It was indicated that the patient presented to the doctor on 02/16/01 with '5 lessions on her forearms" which had started 02/10/01 0r 02/11/01. FOLLOW-UP infromation has been received from a health care professional who reported that on 01/19/01 (previously reported as 01/06/01) the patient developed discrete scattered papules. It was noted that the papules resolved and then reappeared one month later. A reactive RPR and FTA were performed,but the results werenot provided. The patient recovered. No further information is expected. Y Y 12/27/2000 01/06/2001 10 Rapid plasma reagin card - 01/01/01, FTA-ABS-01/01/01 OTH OTH NONE Back pain, cardiac murmur, migraine, peptic ulcer WAES01021393 1
0172186 06/01/2001 NY U 05/15/2001 Information has been received from a physician concerning "at least two health care workers" who were vaccinated with varicella virus vaccine live. Subsequently the patients did not show seroconversion upon titer testing. The physician had no further details. Additional information has been requested. U Serum varicella zoster-pts did not seroconvert OTH OTH UNK UNK WAES01021397 1
0172187 06/01/2001 MO 6.0 1 .2 U 05/15/2001 On 02/17/2001 the patient developed chicken pox. The patient's physician confirmed over the phone and treated the patient with Benadryl. Additional information has been requested. U 10/05/1995 02/17/2001 1962 OTH OTH UNK UNK WAES01021432 1
0172188 06/01/2001 NJ 6.0 1 .1 F 05/15/2001 On 02/15/2001 the patient developed and was diagnosed with chicken pox. The patient had 75 lesions located on her trunk and vaginal area. The patient complained of a sore throat. Additional information has been requested. Y U 02/02/1996 02/15/2001 1840 OTH OTH UNK UNK WAES01021440 1
0172189 06/01/2001 NY 8.0 2 .7 F 05/15/2001 Post vax, the patient developed varicella. Unspecified medical attention was sought. The patient's brother and sister had similar experiences following exposure to varicella virus vaccine. Additional information has been requested. Y U 04/01/1995 UNK UNK UNK UNK ~Varicella (Varivax)~~6.00~In Sibling|~Varicella (Varivax)~~3.00~In Sibling WAES01021600 1
0172190 06/01/2001 NY 3.0 F 05/15/2001 Post vax, the patient developed varicella. Unspecified medical attention was sought. The patient's brother and sister had similar experiences following exposure to varicella virus vaccine. Additional information has been requested. Y U UNK UNK UNK UNK ~Varicella (Varivax)~~6.00~In Sibling|~Varicella (Varivax)~~6.00~In Sibling WAES01021601 1
0172191 06/01/2001 TX 1.2 1 .2 M 05/15/2001 On 12/24/2000 the patient experienced herpes zoster. The patient was not hospitalized. In January 2001, the patient recovered. Additional information has been requested. Y 06/14/1995 12/24/2000 2020 PVT PVT UNK WAES01021688 1
0172192 06/01/2001 KY 2.0 2 .0 M 05/15/2001 On 02/19/2001 the patient's mother called the office to tell them that her son had a mild case of chicken pox. It was reported that the child had less than 30 lesions and a low grade fever. Unspecified medical attention was sought. Follow up information has been received which states that the patient had "about 30 lesions, no fever, stuffy nose, and itch". The patient was advised to use Aveeno anti itch. Additional information has been requested. Y U 06/23/1997 02/19/2001 1337 PVT PVT NONE UNK WAES01021721 1
0172194 06/01/2001 PA 1.5 M 05/15/2001 On 02/21/2001 the patient developed a log grade fever, diarrhea, and a rash with papulovesicular lesions (20 total) on his trunk, neck, extremities and face. FOLLOW-UP information indicated that the patient recovered. No additional is expected. Y U 08/23/2000 02/21/2001 182 PVT PVT amoxicillin, Benadryl Pharyngeal erythema UNK WAES01021846 1
0172195 06/01/2001 TX 6.0 6 F 05/15/2001 On 02/22/2001 the patient developed chicken pox with approximately 20 lesions and no other symptoms. On 02/27/2001 the patient had recovered. Y 04/17/1999 02/22/2001 677 PUB PUB UNK UNK WAES01021864 1
0172196 06/01/2001 ME U 05/15/2001 Post vax, the patient developed a local injection site reaction. Additional information has been requested. U OTH OTH UNK UNK WAES01021868 1
0172197 06/01/2001 MD 1.0 1 .1 M 05/15/2001 On 02/15/2001 the patient developed varicella lesions. On 02/17/2001 the patient had a fever of 102.5F and was diagnosed with bilateral otitis media. The patient was treated with Augmentin. The patient recovered. Y Y 02/07/2001 02/15/2001 8 OTH OTH UNK UNK WAES01021920 1
0172198 06/01/2001 WI 35.0 34 F 05/15/2001 Pt was vaccinated with first varicella virus vaccine on 7/8/98. She received her second vaccination on 8/4/98. There were no concomitant meds. The pt had these vax in anticipation of becoming pregnant within the following year. The pt found out that she was pregnant in 1/00. On 2/9/00, pt had a blood test to see if she was immune to the varicella virus. The "Zoster Virus IGG" showed that she had no immunity to the varicella zoster virus. According to her rpt, in order to be immune a pt's score should be no less than 0.9. Her score was 0.12. The pt sought unspecified medical attention. No further details were provided. There were no adverse events noted. No further info is expected. Y U 08/04/1998 02/09/2000 554 2/9/00 Serum varicella zoster 0.12 OTH OTH NONE Penicillin and Bactrim allergy WAES01021923 1
0172199 06/01/2001 MN 1.2 1 .2 F 05/15/2001 On 2/22/01, pt developed a varicella-like rash of approximately 20 to 30 lesions distributed over her entire body. Slight fatigue was also noted. Conservative care was provided including antihistamines and oatmeal baths. The duration of the lesions was approximately 5 days before they crusted completely. Unspecified medical attention was sought. The pt recovered from these events. No further info is available. Y Y 06/19/1995 02/22/2001 2075 PVT PVT Macrodantin Urinary tract infection Recurrent urinary tract infecions WAES01021926 1
0172200 06/01/2001 MD U 05/15/2001 The patient developed chicken pox about 3 years after receiving the vaccine. Unspecified medical attention was sought. Additional information has been requested. Y U UNK UNK UNK WAES01021938 1
0172201 06/01/2001 VA 1.9 1 .9 F 05/15/2001 On 02/23/2001 the patient developed chicken pox. The patient had 14 lesions on the body, 13 of them were papular and one was vesicular. The patient developed a low grade fever of 99F, an ear infection, coughing, vomiting, hyperemic tonsillitis, papalar, vesicular rash over the chest and trunk. No further information is available. Y Y 03/09/1998 02/23/2001 1082 PVT OTH UNK WAES01021940 1
0172202 06/01/2001 MD 33.0 33 F 05/15/2001 Information has been received from an RN concerning a patient with asthma and no known allergies who on 06/21/1996 was vaccinated with the first dose of varicella. The RN reported that the patient received the second dose "sometime thereafter". Concomitant therapy included asthma medication as needed. The RN reported that a titer was drawn in 1999 and the "patient failed to seroconvert". Unspecified medical attention was sought. Additional information has been requested. Y U 06/21/1996 07/07/1999 1111 Serum varicella zoster on 07/07/1999, failed to seroconvert OTH OTH Therapy (unspecified) Asthma WAES01021946 1
0172203 06/01/2001 NJ 1.0 1 .1 M 05/15/2001 On 02/22/2001 the patient presented to the doctor's office with a vesicular rash from his left buttock to his left knee. It was reported that the doctor feels it is herpes zoster. FOLLOW-UP information has been received froma physician who did not feel there was any need to collect isolates. Follow up information from a physician states "no adverse event from vaccine itself, but the patient developed classic dermatomal shingles on the left buttock and left leg". The rash was described as 50 vesicular lesions at the left buttock and left lateral upper leg to the lateral knee". It was noted that the patient was afebrile, had nasal congestion, and was cranky, but consolable. The reporting physician also noted "this is not an adverse reaction to the vaccine. This is primary or secondary vaccine failure". On 03/13/2001 the doctor reported that the patient is improving now. FOLLOW-UP information has been received from aphysician who states Varivax didn't cause his shingles.It was also noted that the physician "did not consider this an adverse event". Y N 11/19/1999 02/22/2001 461 NONE PVT PVT NONE NONE WAES01021961 1
0172204 06/01/2001 4.0 M 05/15/2001 Information has been received from the CDC concerning a 4.5 year old male who on 11/14/1997 was vaccinated with one dose of varicella. He was exposed to his 11 year old sister who had developed chicken pox at the age of 9, and developed herpes zoster on 11/10/2000. On 12/01/2000 the patient experienced varicella. He was mildly ill with a low grade fever and approximately 150 vesicular lesions located on the trunk, perianal area, face and scalp. The patient was in the school two days before his rash, and on the day the rash was noted was sent home. 23 other children at the same daycare experienced varicella. Fifteen of whom were vaccinated with varicella and eight of whom were not. No further information is available. Per F/U 6/18/02: The sister's herpes zoster was confirmed by Tzanck preparation of her lesions. The pt was bedridden for 1 day and appeared "moderately sick" to his parents. Approx. 2 weeks after rash onset in the index case there were 17 secondary cases (5 cases in unvaccinated children and 12 cases in vaccinated children), and 2 weeks after the secondary cases, a 3rd generation of infections occurred (n-5). The final case of the 4th generation of infection occurred 2 weeks after the prior generation. Additionally, 1 nine year old child developed herpes zoster during the outbreak, 7 years after primary varicella infection (WAES01072736). A susceptible parent of 2 breakthrough cases developed greater that 500 lesions (WAES01072737). F/U info from a published article indicated that "95 (100%) parent and 94 (99%) provider questionnaires were returned. The median age of the 76 (80%) children who attented continuously was 4.2 years (range: 6 months-8 years); 74% were male. Vaccination coverage was 75%. Of 23 cases of varicella, 15 (65%) occurred in vaccinated children and 8 (35%) occurred in unvaccinated children. The index case was a 4 year old vaccinee who developed BT on 12/1/00, PCR in another. Vaccine effectiveness was 40.5% (95% CI: -7.2, 67) overall and 41.7% in the building where the outbreak was centered." No further information is available. Reported on 04/11/2003: " Follow-up information from a published article as titled above indicated that the index patient was a healthy, vaccinated, four year old male who had an onset of rash on 12/01/2000, approximately three years after vaccination on 11/14/1997. The patient attended a day care center two days before the onset of rash and briefly on the morning on which the rash erupted, before he was taken home. the child was moderately ill, with a generalized rash consisting of approximately 150 vesicular lesions and a temperature of 102.5F, remained bedridden for one day, and had no complications. His only known exposure to varicella-zoster virus was contact with an 11 year old sister who did not attend the day care and who had herpes zoster (confirmed by Tzanck testing) on her left arm and back beginning on 11/10/2000 (21 days before the onset of rash in the index patient). The index case gave rise to 15 secondary cases in which 45.8 percent were among vaccinated children. Follow-up information from a published editorial as titled above indicated that the child, who had been vaccinated three years previously, had moderately severe varicella due to what was undoubtedly the wild-type virus and transmitted this virus to 15 other children, most of who had also been immunized. No further information is available. A copy of the published article is attached as further documentation of the patient's experience. U 11/14/1997 12/01/2000 1113 OTH OTH UNK Herpes zoster exposure WAES01022046 1
0172205 06/01/2001 NY F 05/15/2001 Three weeks post vax the patient developed an acne-like breakout on her face and neck. The lesions were described as small, vesicular and initially pruritic but quickly healed over and ceased to itch. They appeared in blotchy patches and she has had a total of about 25 to 30 lesions which appeared in clusters of ten about once a week starting three weeks post vax. They appear and resolve within a few days. The patient has no other complaints or discomfort. Additional information has been requested. U OTH OTH UNK UNK WAES01022047 1
0172206 06/01/2001 2.0 1 .8 F 05/15/2001 On approximately 02/26/2001, post vax, the patient broke out "with a full rash of over 150 lesions. the patient's mother reported that the patient's sibling had broken out approximately 2 weeks ago. The patient did not seek medical attention. U 01/01/1996 02/26/2001 1883 UNK UNK UNK WAES01022066 1
0172207 06/01/2001 NY 3.0 1 .0 M 05/15/2001 On 02/23/2001 the patient experienced a mild case of chicken pox with about 15 pox. He was seen by a physician who diagnosed chicken pox on 02/23/2001. It was noted that one child in the patient's day care had chicken pox just prior to this event. Subsequently the patient recovered. Unspecified medical attention was sought. Y Y 08/18/1998 02/22/2001 919 NONE OTH PVT Varicella exposure WAES01022087 1
0172208 06/01/2001 MA 1.5 1 .6 F 05/15/2001 On 02/20/2001 the patient developed a mild case of chicken pox that included lethargy, itch, 50 vesicles, red spots on her back, chest, face, legs and arms. The patient was exposed at school one week prior. The patient was treated with Benadryl for the itch. The patient sought medical attention. No further information is expected. Y U 02/13/1996 02/20/2001 1834 PVT PVT WAES01022089 1
0172209 06/01/2001 MI 6.0 1 .2 M 05/15/2001 On 01/30/2001, the patient developed varicella. Subsequently, the patient recovered. Y 02/16/1996 01/30/2001 1810 NONE UNK UNK UNK UNK WAES01022118 1
0172210 06/01/2001 CA U 05/15/2001 Post vax the patient experienced "incidence of rash or lesion and transmission". Additional information has been requested. U OTH OTH UNK UNK WAES01022136 1
0172211 06/01/2001 VA U 05/15/2001 Information has been received from a physician concerning 4 children who were vaccinated with varicella virus vaccine live. The physician reported that a mother of a patient reported that 4 other children in a day care setting had come down with chicken pox, "even though they were previously vaccinated." In follow-up, the physician reported that according to a patient's mother, 5 children in day care had chicken pox and all of them had a varicella virus vaccine live some time ago. Additional information is not expected. U UNK UNK UNK UNK WAES01022137 1
0172213 06/01/2001 IA M 05/15/2001 The patient who was vaccinated "a while back", recently was in contact with another child with chicken pox. Subsequently, the patient developed a very mild case of chicken pox, including one vesicle. Unspecified medical attention was sought. Additional information has been requested. Y U UNK UNK UNK varicella exposure WAES01022199 1
0172214 06/01/2001 WI 1.25 1 .3 F 05/15/2001 0n 02/16/2001 the patient developed a "bad case" of chicken pox. There were about 120 lesions. Unspecified medical attention was sought. The patient has recovered. No further information is expected. Y Y 10/09/1995 02/16/2001 1957 PVT OTH NONE NONE WAES01022207 1
0172215 06/01/2001 KS 1.0 U 05/15/2001 On 02/25/2001, two weeks after vaccination the patient broke out with less than 10 pox, believed to be chicken pox. Unspecified medical attention was sought. Additional information has been requested. Y U 02/11/2001 02/25/2001 14 UNK UNK UNK UNK WAES01030037 1
0172216 06/01/2001 FL 33.0 F 05/15/2001 Information has been received from a physician concerning a patient who in approximately 2000 was vaccinated. According to the physician, "a month or two later" she developed acute lymphocytic leukemia. Additional information has been requested.The physician questioned as to if there was a relationship between varicella virus vaccine live and acute lymphocytic leukemia. The physician also believed that the pt's experience was disabling. Additional info has been requested. Y U 01/01/2000 Serum varicella zoster: negative prior to vaccine PUB PUB UNK Drug abuse WAES01030119 1
0172217 06/01/2001 1.0 1 .0 M 05/15/2001 On 03/02/2001 the patient experienced "about 15 chicken pox like lesions". No other symptoms were reported. Unspecified medical attention was sought. FOLLOW-Up information received from the the doctor's office reports that the child was not vaccinated at their facility. The nurse also reports that the parent of this child is a physician and "refused to bring in the child so the varicella could be documented'. No further information is available. Y U 09/09/1996 03/02/2001 1635 OTH OTH NONE WAES01030253 1
0172218 06/01/2001 MN 33.0 33 F 05/15/2001 Information has been received from a patient with mild psoriasis and questionable irritable bowel disease who was vaccinated with two doses of vaccine 4 weeks apart in April 2000. In approximately October 2000, the patient had titers that showed she did not seroconvert. It was reported that the patient received a third dose subcutaneously in the left upper arm on 02/19/2001. Subsequently, the patient experienced an injection site reaction including swelling and pain that began on 02/20/2001 and lasted for 3 days. The pain was so intense she could not sleep on the side of her body that received the injection. The evening of the vaccine administration the patient developed abdominal pain and nausea. The nausea lasted approximately 12 hours and the abdominal pain lasted about 8 hours. Unspecified medical attention was sought. It was reported the patient recovered. Y Y 04/01/2000 10/01/2000 183 serum varicella zoster - patient did not seroconvert PVT PVT irritable bowel syndrome, psoriasis vulgaris WAES01030255 1
0172219 06/01/2001 NY F 05/15/2001 Information has been received from a female consumer who was vaccinated with a dose of Varivax. Subsequently, the patient experienced inferility. The patient sought unspecified medical attention. FOLLOW-UP information received from the registered nurse reported that the patient did not have an adverse experience. No further information is expected. Y U UNK UNK UNK UNK WAES01030282 1
0172220 06/01/2001 NJ 1.7 1 .6 F 05/15/2001 Information has been received from a registered nurse concerning a 6 year old female who on 02/05/96 was vaccinated with varicella virus vaccine live.On 02/26/01,the patient developed chicken pox that included a fever, a pruritic rash with 7 to 10 macular papular rash on the chest,legs and public area. Laboratory evaluations revealed a positive serum varicella virus antibody test, a positive IgG test of5.87,and a positive IgM test 11. The patient recovered. No further information is expected. Y Y 02/05/1996 02/26/2001 1848 Immunoglobulin G index - positive, Serum immunoglobulin M - positive, Serum varicella zoster - positive PVT PVT UNK NKA WAES01030266 1
0172221 06/01/2001 NJ 37.0 37 F 05/15/2002 On 02/20/2001, the patient experienced a pruritic diffuse erythematous papular rash over her face,neck, and upper chest. She had no fever. She also had puffy upper eyelids, dry facial skins,and hypermia. The patient was seen in the nurse practitioner's office on 03/02/2001 and the rash was diffused and red. She had no lesions at the site of the injection or over her arms or vesicular lesions. On exam, she had an isolated nontender palpable left preauricular lymph node. She was treated with 25 mg of Atarax and Lac-Hyrdrin with resolution of pruritus and swelling. On 03/08/01, and she developed an erythematous punctuated papular lesions. On 03/14/01, the patient recovered. Additional information is not expected. Y Y 02/16/2001 02/20/2001 4 NONE OTH OTH UNK Skin disorder WAES01030292 1
0172222 06/01/2001 IA 1.25 2 .2 F 05/15/2001 On 12/09/2000 the patient developed chicken pox with approximately 12 pox. On 12/14/2000 the patient developed a cough. The patient was seen in the office with a cough, pharyngitis and viral syndrome. Subsequently, the patient recovered. Additional information has been requested. Y Y 07/02/1998 12/29/2000 911 PUB PUB UNK UNK WAES01030362 1
0172223 06/01/2001 GA 1.3 1 .4 M 05/15/2001 On 02/21/2001 the patient experienced shingles on his right thigh. The patient had no history of clinical varicella. The patient fully recovered. A herpes zoster questionnarie indicated that on 02/27/02 the herpes zoster broke out right L3 distrubution, the duration was about 10 days on oral Acyclovir.Normal temperature pain rated a 7. There was no history of chicken pox. A photo was included. Y 09/23/1996 02/21/2001 1612 PVT PVT UNK WAES01030363 1
0172224 06/01/2001 VA 1.0 1 .0 M 05/15/2001 On 02/23/2001 the patient developed more than 50 varicella lesions on his trunk and extremities. The patient sought unspecified medical attention and recovered. Additional information has been requested. Y Y 02/13/2001 02/23/2001 10 PVT PVT UNK WAES01030373 1
0172225 06/01/2001 MS F 05/15/2001 One day post vax, the patient experienced a rash on her deltoid at the injection site which was described as a 3-4cm encrusted scab-like area. It was reported that the rash lasted for one week and that the patient recovered. Additional information has been requested. Y OTH OTH UNK WAES01030396 1
0172226 06/01/2001 MI 38.0 38 M 05/15/2001 On approximately 03/02/2001 the patient developed a fever of 101F and a chicken pox-type rash. The patient did not recall being exposed to wild type virus. Additional information has been requested. Per F/U 6/18/02: Info has been received from a health professional concerning a 38 year old male with no past medical history who on 2/13/01 was vaccinated SC in the left arm with a 1st dose of varicella virus vaccine live (lot 635208/0076K). There was no illness at the time of vaccination. On 3/1/01, the pt developed a fever of 102F (also reported as 101F) and "broke out with a chicken pox-type rash all over his body". Subsequently, the pt recovered. Y 02/14/2001 03/02/2001 16 Temp-101.1F on 3/3/01 PVT PVT NONE NONE NONE WAES01030439 1
0172227 06/01/2001 1.0 1 .0 M 05/15/2001 On 03/02/2001 the patient developed one dot on his back and a cluster of 3 on his right hip. They were "red mosquito bite looking dots". On 03/03/2001 the patient was seen by his physician and diagnosed with chicken pox. The spots were then white in the middle and itching. On 03/04/2001 2 more developed. FOLLOW-UP unformation received from a physician indicated that there was "no vacccine reaction". The patient experienced mild varicella 1 year following administration of the vaccine. Additional information is not expected. Y U 06/09/1999 03/02/2001 632 OTH OTH UNK UNK WAES01030441 1
0172228 06/01/2001 MD 5.0 1 .1 F 05/15/2001 On 03/05/2001 the patient presented to the doctor's office with varicella. The patient developed a scattered papulovesicular eruption on her neck, arm and back, some crusted, others vesicular. The patient had no fever. Additional information has been requested. Per F/U 6/18/02: Information has been received from an LPN concerning a 5 year old Caucasian female with no known allergies or past medical history who on 2/21/97 was vaccinated with the 1st dose of varicella (lot 2717-14-invalid), SC in the left arm. On approx. 3/5/01, the pt developed varicella and was seen in a physician's office. It was reported that "there was a rash and no fever". It was also noted that the pt had "scattered papulovesicular eruption on neck, arm, back-some crusted, others vesicular". F/U from a physician reported that there was an "erythema papulovesicular rash generalized in different stages of healing". It was reported from the physician, that the pt recovered. No further info is available. Y Y 02/21/1997 03/05/2001 1473 PVT PVT UNK NONE WAES01030501 1
0172229 06/01/2001 7.0 7 F 05/15/2001 Ten days post vax the patient experienced a low grade fever and tiredness. On approximately 03/06/2001, the patient developed a rash all over her body. Unspecified medical attention was sought. Additional information has been requested. Y U 02/20/2001 03/02/2001 10 UNK UNK UNK UNK WAES01030516 1
0172230 06/01/2001 NM 4.0 4 F 05/05/2001 On 03/04/2001 the patient developed a severe varicella rash on her scalp, mouth, face, back, legs and arms. Unspecified medical attention was sought. Additional information has been requested. Y U 09/29/1998 03/04/2001 887 OTH OTH UNK Henoch-Schonlein purpura, arm fracture WAES01030588 1
0172231 06/01/2001 MI 4.0 4 F 05/15/2001 The patient has experienced numerous respiratory infections since September of 2000 and was diagnosed with bronchial asthma as well. The patient developed eczema on her arms 1 week after immunization on 09/22/2000. On 10/06/2000 the patient developed a fever of 102F. On 10/07/2000 she experienced a cough progressing to "croupy non-stop worse at night". The patient experienced posterior headaches and was diagnosed with cervical pharyngitis and laryngitis. On 11/13/2000 the patient developed cervical adenitis and pharnygitis. On 11/14/2000 the patient developed a cold for three days. On 12/20/2000 the patient developed a runny nose, bronchial cough and bronchitis. On 01/11/2001 the patient experienced otitis media. On 02/27/2001 the patient experienced an upper respiratory infection and bronchitis. The patient was treated with Ventolin, amoxicillin, azithromycin, Zyrtec, and Zithromax. Subsequently, it was noted that the patient recovered from eczema, cough and asthma. Additional information is not expected. Y Y 09/15/2000 PVT PVT NONE ~Varicella (Varivax)~~6.00~In Sibling WAES01030627 1
0172232 06/01/2001 FL U 05/15/2001 Information has been received from a physician's office manager concerning 5 patients who were vaccinated with varicella virus vaccine live. Subsequently the patients developed chicken pox lesions. Unspecified medical attention was sought. Additional information has been requested. Y U OTH OTH UNK UNK WAES07030763 1
0172234 06/01/2001 TX 4.0 4 M 05/15/2001 Information has been received from a nurse concerning a male patient who on 09/11/1996 was vaccinated and subsequently experienced chicken pox. Unspecified medical attention was sought. Additional information has been requested. Per F/U 6/18/02: Pt was vaccinated SC, in the left arm with a 1st dose of varicella (lot 617694/0772D). The nurse indicated that on 3/6/01; the pt developed chicken pox after exposure at school. As of 5/1/01, it was noted that the child recovered from the chicken pox. The nurse also reported that the pt's sister developed chicken pox in 3/01, after exposure to her brother, and receiving varicella vaccine on 11/16/95 (WAES01042615). Additional info is not expected. Y U 09/11/1996 03/06/2001 1637 PVT PVT UNK Varicella exposure ~Varicella (Varivax)~1~1.00~In Sibling WAES01030770 1
0172235 06/01/2001 MI 6.0 6 M 05/15/2001 On 09/18/2000 the patient was seen in his physician's office with a sore throat, congested cough, wheezing and headache. Asthma was diagnosed the same day and the patient was referred to an allergist and pulmonologist. The patient was treated with Serevent and Intal. Subsequently, the patient recovered. Additional information is not expected. Y Y 09/15/2000 09/18/2000 3 PVT PVT UNK NONE ~Varicella (Varivax)~~4.00~In Sibling WAES01030776 1
0172236 06/01/2001 FL 40.0 40 M 05/15/2001 On 03/01/2001 the patient presented with a papulovesicular rash on his chest and trunk. The patient did not have a fever. On 03/05/2001 the patient had recovered. Y Y 02/06/2001 03/01/2001 23 UNK UNK UNK UNK WAES01030778 1
0172237 06/01/2001 AZ 1.08 1 .1 M 05/15/2001 On 03/05/2001 the patient experienced a chicken pox outbreak, around 32 pox. The patient did not have a fever. The patient did not have known contact with wild type chicken pox. Additional information has been requested. Per F/U 6/18/02: Info has been received from a health professional concerning a 4 year old male child with no known medical history or allergies who on 4/25/97 was vaccinated SC in the right arm with a 1st dose of varicella vaccine (lot 622681/0087E). There was no illness at the time of vaccination. On 3/5/01, the pt developed a chickenpox outbreak (around 31 pox) over 24 hours. The pt had a fever and itching. Pt did not have known contact with wild type chicken pox. There was no relevant diagnostic tests and lab data. Subsequently, the pt recovered. Additional info is not expected. Y Y 04/25/1997 03/05/2001 1410 NONE PVT PVT UNK NONE NONE WAES01030821 1
0172238 06/01/2001 1.0 1 .0 M 05/15/2001 On 03/05/2001 the patient experienced a chicken pox outbreak, greater than 20 pox, mostly on the trunk and groin areas. The patient experienced nausea and vomiting. The patient had no fever. The reporter was not sure if the patient was exposed to a wild type virus. No additional information is expected. U 11/23/1998 03/05/2001 833 OTH OTH UNK UNK WAES01030822 1
0172239 06/01/2001 TN 15.0 M 05/15/2001 On 03/01/2001 the patient experienced injection site swelling, redness and injection site pain. The physician felt the booster shot may have been administered into a vein. A few days later the physician saw the patient and a little swelling remained. The patient was not experiencing discomfort. The patient was treated with antibiotics to prevent cellulitis. Additional information has been requested. Per F/U 6/18/02: This was the pt 2nd dose of varicella vaccine. On 3/1/01, the pt experienced a local reaction, distal to the injection site. Some swelling with warmth, redness and injection site pain (to touch) was noted. The pt's mother felt the booster shot may have been administered into a vein. A few days later, the phsycian saw the pt and a little swelling remained. The pt was not experiencing discomfort. Therapy with antibiotics was initiated to prevent cellulitis that might occur. On 4/27/01, the physician noted that the pt was "doing fine". On 5/14/01, the physician reported that his condition completely resolved and did not anticipate any further symptoms. Additional info has been requested. Y Y 03/01/2001 03/01/2001 0 OTH OTH UNK UNK WAES01030894 1
0172240 06/01/2001 M 05/15/2001 The pt developed what appeared to be chicken pox. Additional information is not expected U OTH OTH UNK UNK WAES01030895 1
0172241 06/01/2001 PA 11.0 6 M 05/15/2001 Information has been rec'd concerning a pt with peanut allergy who on 6/20/95 was vaccinated with varicella virus vaccine live. The reporter stated that the pt broke out with very mild bumps, almost acne looking bumps on 12/7/00. They were mainly on his forehead. The reporter contacted the pt's physician. The reporter also noted that her other son experienced headache. fever, and mild rash on 12/7/00. (WAES#010309241). additional information has been requested. Y U 06/20/1995 12/07/2000 1997 OTH OTH UNK Concurrent conditions: nuts allergy. headache,fever, rash~Varicella (Varivax)~~0.00~In Patient WAES01030915 1
0172242 06/01/2001 PA 7.0 2 .0 M 05/15/2001 Information has been rec'd from the mother of a 7 yo male consumer who on 6/20/95 was vaccinated with varicella virus vaccine live. There no concomitant medication. On 12/7/00 the pt developed a mild rash primarily on his trunk, a fever and headache. The itching lasted approximately 2 days. The mother also reported that her other son had a rash after vaccination with varicella virus vaccine live (MSD) (WAES01030915) Additional information has been requested. U 06/20/1995 12/07/2000 1997 OTH OTH NONE UNK WAES01030924 1
0172243 06/01/2001 MI 3.0 4 F 05/15/2001 On 2/24/01 the pt became fussy and by 2/26/01 the pt had developed a total of 40-50 lesions. No other symptoms were reported. subsequently, om 03/09/01, the patient recovered. No further information is available. U 11/15/2000 02/24/2001 101 OTH OTH NONE UNK WAES01031001 1
0172244 06/01/2001 MD 5.0 M 05/15/2001 On 03/01/2001 the patient experienced jerking of shoulders, shaking of head, seeing light and dark spots and saying "my head itches". The patient was seen in the ER on 03/02/2001, examined and released. No treatments or medications were prescribed. On 03/09/2001 the patient's symptoms were more persistent. The patient was scheduled for a CT of the brain. No further details were provided. Additional information has been requested. Y N 02/28/2001 03/01/2001 1 OTH OTH NONE UNK WAES01031036 1
0172245 06/01/2001 PA 4.0 4 F 05/15/2001 On 10/23/2000 the patient was seen and diagnosed with early varicella. The patient developed 125 lesions, a low grade temperature and pruritus which was treated with Benadryl. On an unspecified date the patient recovered. No further information is available. Y Y 09/28/1995 10/23/2000 1852 PVT PUB NONE NONE WAES01031065 1
0172246 06/01/2001 MA 0.9 1 .0 M 05/15/2001 On 03/09/2001 the patient developed chicken pox. The patient sought medical attention. Additional information has been requested. Per F/U 6/18/02: Info has been received from an RN concerning a 42 month old Asian male with an amoxicillin allergy who on 8/20/98 was vaccinated with the 1st dose of varicella vaccine (lot 625047/1574E) in the PM, SC in the left thigh. On 3/9/01, the pt developed chicken pox. The pt had "many vesicles with fluid on torso, face and arms". It was also reported that there were "some scabs noted". It was noted to be an apparent breakthrough of varicella. The pt sought unspecified medical attention. Additional info has been requested. Y U 08/20/1998 03/09/2001 932 PVT PVT UNK amoxicillin allergy WAES01031283 1
0172247 06/01/2001 KY 1.0 1 .0 F 05/15/2001 On 03/11/01 the patient developed chicken pox that included 10-12 papular/vesicular lesions, The patients had bumps on the torso and back legs". the patient sought medical attention and was treated with Benadryl and Tylenol. It was reported that the patient recovered. Additional information has been requested. Y Y 05/19/1999 03/12/2001 663 UNK UNK UNK UNK WAES01031294 1
0172248 06/01/2001 CA U 05/15/2001 Information has been received from a medical assistant concerning several patients who have experienced rashes and local injection site reactions. Unspecified medical attention was sought. No further information is available. Y U UNK UNK WAES01031329 1
0172249 06/01/2001 NJ 39.0 F 05/15/2001 Two weeks post vaccination the pt developed herpes zoster. One year later, the pt had herpes zoster again. The pt sought unspecified medical attention. Additional information has been requested. Y U OTH OTH UNKI UNK WAES01031478 1
0172250 06/01/2001 VA F 05/15/2001 Information has been received from a physician concerning a patient's mother. The patient's mother had a history of varicella at 12 years old. On 02/09/1998, the patient was vaccinated with varicella virus vaccine live, subcutaneously in the left thigh and on 02/23/2001 presented in the physician's office with chicken pox. The physician reported that the patient's mother who had a chicken pox when she was 12 years old, had a chicken pox from her child two weeks later. The physician also reported on the daughter who experienced events following vaccination with varicella virus live. No further information available. U 03/09/2001 OTH OTH UNK WAES01031721 1
0172251 06/01/2001 MI 7.0 3 F 05/15/2001 Information has been rec'd from hlth professional concerning a pt who on 7/15/97 was vaccinated with 1 dose of varicella virus vaccine live. On 3/14/01 the pt experienced chicken pox with a fever of 101F, sore throat, and approximately 10 lesions. Medical attention was sought. F/U 6/18/01: The pt had no known allergies. The varicella vaccine lot (621192/1550D) SC in the left arm. He had approx. 50 lesions. On 3/20/01, the pt recovered from her chickenpox. Additional info is not expected. Y Y 07/15/1997 03/14/2001 1338 PUB PUB UNK UNK WAES01031770 1
0172252 06/01/2001 PA 2.0 1 1 M 05/15/2001 On 03/11/2001, the patient developed chickenpox that was noted to be a "really bad case of it". The patient had between 100 and 200 pox marks that are all over his body, even his mouth and throat. It was reported that the patient went to a rollerskating party and several of the children subsequently broke out with the chickenpox. It was noted on 03/15/2001 the patient was still breaking out with the chickenpox. The patient sought unspecified medical attention. Additional information has been requested. Y Y 08/12/1996 03/11/2001 1672 OTH OTH Zyrtec allergy, drug allergy Otic infection, otic tube insertion, streptococcal pharyngitis WAES01031776 1
0172253 06/01/2001 PA 11 M 05/15/2001 The patient experienced a "break through case of varicella" with less than 20 eruptions on his forearms and abdomen. As of 03/16/01, the patient had recovered from the "break through case of varicella" Additional information is not expected. U 03/04/2001 03/10/2001 6 OTH OTH UNK UNK WAES01032012 1
0172254 06/01/2001 NY 4.0 F 05/15/2001 The patient at the age of 1 year in 1997 was vaccinated with one dose of varicella virus vaccine live. On 03/16/2001 the patient developed herpes zoster, "shingles" on her right arm. The patient was seen by a dermatologist who sent an isolated culture. The result of the culture was unknown, since they were not able to isolate or grow the culture or determine whether it was wild type or vaccine. Additional information has been requested. Y U 03/12/2001 DNA - results unknown OTH OTH UNK UNK UNK WAES01032170 1
0172255 06/01/2001 GA 1.08 1 .0 F 05/15/2001 Information has been rec'd from a hlth professional concerning a pt with no past medical history and no know drug allergies who on 2/9/01 was vaccinated with a dose of varicella virus vaccine live (lot 635601 1148K) . On 3/12/01 the pt developed a rash. On 3/16/01 the pt presented at the doctor's office with a rash of > 20 vesicles, scabbing over. Predominately on the scalp and around the ankles. No further information is available. Y U 02/09/2001 03/12/2001 31 UNK UNK UNK UNK WAES01032181 1
0172256 06/01/2001 NY 2.0 F 05/15/2001 Information has been rec'd from a physician and a hlth care professional concerning a pt who on 6/29/00 was vaccinated with varicella virus vaccine live. In December 2000 (previously reported as December 1999), the pt developed breakthrough chicken pox on her abdomen, buttocks, and legs after exposure to her brother who had shingles, Subsequently, the patient recovered. The reporters provided information regarding the patient's brother (WAES00121480). additional information has been requested. Y 06/29/2000 12/01/2000 155 OTH OTH UNK Herpes Zoster exposure ~Varicella (Varivax)~1~5.00~In Sibling WAES01032315 1
0172257 06/01/2001 NJ 1.08 U 05/15/2001 Information has been rec'd from a physician concerning a pt who was vaccinated with varicella virus vaccine live (site unknown). Subsequently the pt developed mild varicella. The pt's sister experienced mild varicella (WAES01020208) after being vaccinated also. Additional information is not expected. U OTH OTH UNK UNK ~Varicella (Varivax)~1~3.50~In Sibling WAES01032370 1
0172258 06/01/2001 GA 6.0 13 F 05/15/2001 After being vaccinated the pt subsequently experienced mild chickenpox. Another group was reported with chickenpox following vaccination. U 03/06/1997 PUB PVT UNK UNK WAES01033292 1
0172259 06/01/2001 FL 9.0 9 M 05/15/2001 Information has been received from the mother of a male child who on 7/25/00 was vaccinated with one dose of varicella virus vaccine live. Subsequently the patient experienced a light case of chicken pox live. Subsequently the pt experienced a light case of chickenpox with 100 lesions or a severe case of chickenpox (one sibling developed a severe case, and one developed a light case); the reporter did not specify which sibling developed which case. It was noted the pt had been exposed to varicella approximately 24 months after vaccination with no problems. the pt's sibling had a similar reaction following vaccination with varicella virus vaccine live (WAES00090699) U 07/25/2000 UNK UNK UNK UNK ~Varicella (Varivax)~~0.00~In Sibling 1
0172260 06/01/2001 U 05/15/2001 Information has been received from the CDC concerning 4 children in one classroom who were vaccinated with varicella virus vaccine live. The children were exposed to a classmate (WAES00120576) who had developed chickenpox. Subsequently the 4 children also developed chickenpox. Additional pt (WAES01034330-01034331) had a similar experienced following exposure to varicella virus vaccine live. No further information is available. U OTH OTH UNK varicella exposure WAES01034329 1
0172261 06/01/2001 GA 5.0 U 05/15/2001 Information has been received from the CDC concerning a 5 year old child with a history of asthma who was vaccinated with varicella virus vaccine live. the child was exposed to a classmate (WAES00120576) who had developed chickenpox. Subsequently the pt experienced chickenpox consisting of 100-250 lesions. It was noted that the pt was not on any steroids at the time of his vaccination or at the time of the onset of his illness. Additional patients (WAES01034029,01034331) had a similar experience following exposure to varicella virus vaccine live. U OTH OTH UNK Varicella exposure WAES01034330 1
0172262 06/01/2001 GA F 05/15/2001 U Information has been received from the CDC concerning a female child who was vaccinated with varicella virus vaccine live. In approximately 1998 the pt developed a clinical case of chickenpox which was treated with acyclovir. Subsequently the pt was exposed to her brother (WAES00120576) and experienced chickenpox for the second time. Additional patients (WAES00120576,01034329 and 01034330) had a similar experience following exposure to varicella virus vaccine live. OTH OTH UNK Varicella, varicella exposure ~Varicella (Varivax)~~0.00~In Sibling WAES01034331 1
0172263 06/01/2001 MA U 05/15/2001 Information has been received from the CDC concerning approximately 17 patients who were vaccinated with varicella virus vaccine live. Subsequently the patients experienced chickenpox. Additional patients (WAES01034333-01034335) also developed chickenpox following exposure to varicella virus vaccine live. No further information is available. U OTH OTH UNK UNK WAES01034332 1
0172264 06/01/2001 MA 3.0 U 05/15/2001 Information has been received from the CDC concerning a 3 year old child who on 7/17/98 was vaccinated with varicella virus vaccine live. Subsequently the patient experienced 50-250 lesions of chickenpox and a fever that lasted approximately 4 days. Unspecified medical attention was sought and it was noted that the child had four fold rise in the antibody titer. Additional patients (WAES01034332,01034334-0103435) also developed chickenpox following exposure to varicella virus vaccine live. Y Y 07/17/1998 Serum varicella zoster-4 fold rise in antibody titer UNK UNK UNK UNK WAES01034333 1
0172265 06/01/2001 MA 4.0 U 05/15/2001 Post vax, the patient experienced between 50-250 lesions of chickenpox and a fever of 102F. Unspecified medical attention was sought and it was noted that a wild type virus was isolated from the skin lesion. Y U DNA - cutaneous lesion positive for wild type virus UNK UNK UNK UNK WAES01034334 1
0172266 06/01/2001 MA 3.0 U 05/15/2001 A 3 yr old child in 1999 was vaccinated with varicella virus vaccine live. The pt developed 250-500 lesions of chickenpox and fever of 2 days duration. Unspecified medical attention was sought and it was noted that a wild type virus was isolated from a cutaneous lesion. Y U UNK UNK WAES01034335 1
0172267 06/01/2001 28.0 27 F 05/15/2001 A 28 yr old female with no known drug allergies, who on 27-DEC-2000 was vaccinated with the first dose of varicella virus vaccine live. The reported that the pt missed her second dose. On 29-MAR-2001, the patient experienced slight rash and reported that two days ago she was exposed to chickenpox. Unspecifed medical attention was sought. Y U 12/27/2000 03/29/2001 92 UNK UNK UNK UNK WAES01034406 1
0172269 06/01/2001 OK 13.0 F 05/15/2001 A 13 year old american indian female who on 06-AUG-1998 was vaccinated with one dose of varicella virus vaccine live. She was 14 weeks pregnant at the time of vaccination. LMP was 27-APR-1998. EDD is 03-FEB-1999. She was vaccinated with the second dose of varicella virus vaccine live on 29-SEP-1998. Evaluation revealed good fetal heart tone. Laboratory evaluation revealed HCG positive on 28-OCT-1998. On 30-JAN-1999 the pt gave birth to a normal healthy female by normal spontaneous vaginal delivery. Birth weight was 8 lb , 3.8 oz. Apgar score was 8/9. Coomb's test was positive. The baby was hypoglycemic. There was a B-O blood group incompatibility. The infant also had increased reticylocytes. The infant had hyperbilirubinemia and a lax left hip. Laboratory evaluation on 30-JAN-1999 for the baby revealed a negative blood culture, a negative vaginal surface culture (no group B streptococcus isolated), negative urine culture,type + Coomb's test for cord blood, (mother's cord blood O+), and hematocrit 55.2. Total bilirubin on 30-JAN-1999 was high 10.28 (high). Additional readings indicated total bilirubin 7.39 (high)and direct bilirubin was 0.56 (high). Indirect bilirubin was 6.83 (normal). On 30-JAN-1999 WBC was 39.4 ;basophil %0; neutrophil number 29.8; lymphocyte number 10.7; monocyte number 3.6; eosiniphil #0.4; basophil number 0; hemoglobin 20.2; hematocrit 59.4; MCV 107.2; MCH 36.5; and RDW 19.5. Microscopic evaluation revealed neutrophils 71; bands 3; lymphocytes 13; monocytes 14; NRBC 13. There are many more blood tests and and values given in report please refer to record. Y U 08/06/1998 01/30/1999 177 fetal monitoring test-good fetal heart tone. Beta human chorionic 10/28/1998-positive. The rest of the laboratory values belong to the newborn. OTH OTH UNK WAES98110784 1
0172270 06/01/2001 TX 28.0 27 F 05/15/2001 No adverse events were reported. The pt was noted to be taking prenatal vitamins throughout her pregnancy. At an unspecified time it was noted that there was premature labor. An ultrasound done on 26-SEP-1999 showed no anomalies. It was reported that during pregnancy the patient was positive for Group B strep. Follow up information received from a physician indicated the patient "moved to Texas". However, on 10/05/99, the patient gave birth via vaginal delievery to a healthy baby girl 8 lbs 6 oz and 20 1/4 inch long, 41 weeks from her last LMP. It was reported that there were no varicella zoster syndrome noted.The baby was seen by a physician on 10/09/99 who noted that she was jaundice. It was reported that the baby was breastfeeding and had two stoools on 10/07/99 and one on 10/08/99. Her bilirubin levels were 17.1 on 10/08/99, 16.1 on 10/09/99, and 11.1 on 10/10/99. No further information is expected. Y Y 01/07/1999 Ultrasound done on 09/26/1999 showed no anomalies; Ultrasound confirmed her pregnancy; Ultrasound -02/16/99 -Normal/preganancy confirmed; Total serum bilirubin -10/08/99 -17.1, Total serum bilirubin -10/09/99 -16.1, total serum bilirubin -10/10/99 -11.1 UNK UNK vitamins (unspecified) concurrent conditions: Pregnancy NOS (LMP -12/20/98), Hypersensitivty WAES99021758 1
0172271 06/01/2001 FL 48.0 F 05/15/2001 A registered nurse with a penicillin and sulfa allergy and a history of LASIK surgery who on 29-MAR-1999 was administering the varicella virus vaccine live to a male (WAES00051539) when the needle exited the skin of the male and the vaccine, contaminated with his blood/body fluids, squirted in her face and left eye. On 29-MAR-1999 the pt experienced a stinging sensation that she stated felt like a sunburn and her eye waters frequently. She is also experiencing a tic in the left eye. In the evening of 29-MAR-2000, she saw a Dr who diagnosed her as having a foreign substance in the left eye. The stinging persisted and she used therapy with re wetting solutions approximately every 1-2 hrs and she experienced a headache on that side and a migraine beginning and sinus. On 30-MAR-2000 pm the stinging was gone and the headache, which had persisted all previous night had worsened and localized to below left eye in sinus area. On 30-MAR-2000 pm experienced gradually building left orbit pain particularly in inner aspect of left eye and with what appear to be muscle spasms in that area every approximately every 20 to 30 minutes. The reporter indicated that during the spasms pain is briefly intense, eyelid partially close without control and the eye tears heavily. On 30-Mar-2000,the reporter indicated that the symptoms persisted but seemed to be lessening gradually. She saw a ophthalmologist and stated that the symptoms have continued to gradually lessen and the pain is helped by massage to inner eye muscle. The ophthalmologist felt the eye looked good and there was no damage to the surgery. She also stated that he doesn't expect any long term problems from the vaccine and in fact it might boost immunity, he also stated that the discomfort was to be expected-a local reaction to a foreign substance. On 01-APR-2000, she developed a slightly swollen eye and vision problems which she feels is due to yesterday's dilation. On 01-APR-2000 she saw a Dr who diagnosed her as having left eye irritation. She says she is feeling better; the muscle spasms are infrequent and the orbit pain is very dull, minor. She was treated with Liquid Tears. She was released from care and could return to work full duty. She had a hepatitis B core antibody test a hepatitis c virus antibody test, rapid plasma reagin card test, a Western blot HIV-1 and HIV-2 antibody test were all non reactive. Hepatitis B surface antibody and Hepatitis B surface antigen test results unknown. At the time of report the tic of the eyelid persisted. Follow up info received on 01-JUN-2000 indicated that there were no complications noted and the matter was resolved. Y Y 03/29/1999 All Laboratory tests normal UNK UNK UNK Ophthalmic surgery, penicillin allergy and a sulfa allergy WAES99032577 1
0172272 06/01/2001 WI 25.0 25 F 05/15/2001 A 25 year old female pt who was vaccinated with a first and second dose of varicella virus vaccine live in January and February of 1999. It was known the pt was definitely pregnant when receiving the second dose. This report is part of the pregnancy registry. Follow Up information reported the pt never returned to the Dr's office after her initial visit and the Dr had no information about the outcome of the pt pregnancy. Follow up information from the Dr's office indicated the on 04-OCT-1999, the pt delivered via C-section and the baby was breech. The pt was also noted that during her pregnancy had several ultrasounds which revealed a short cervix. She also had an amniocentesis done which was normal. The pt was taking prenatal vitamins. The pt had a scheduled C-section because of the breech presentation. The pt gave birth tom a healthy 8 lb 2 oz male infant. Physical exam of the infant showed mild respiratory distress requiring suctioning and oxygen. Occasional rales were heard. On 04-OCT-1999, the infant's Coomb's test was negative. On 05-OCT-1999 the infant was feeding poorly from the breast. On 05-OCT-1999, the hemoglobin screen was abnormal with infant having sickle cell trait. The infant had several bilirubin tests and it was noted that the infant's appetite improved with bottle supplementation. On 09-OCT-1999 the infant was discharged to his mother, his lungs clear, perfusion was good and the mild jaundice had significantly improved. Family testing and genetic counseling was suggested for the child's parents regarding sickle cell trait. Y N 02/01/1999 10/04/1999 245 Amniocentesis -05/2081999- normal screening ; ultrasound results-short cervix OTH OTH prenatal vitamins WAES99040276 1
0172273 06/01/2001 MI 33.0 32 F 05/15/2001 The pt found out she was pregnant following she was vaccinated. At six months ultrasound shows a normal pregnancy. U 05/26/1999 02/19/2000 269 PVT UNK UNK WAES99061594 1
0172274 06/01/2001 PA 21.0 20 F 05/15/2001 Information received from the Varivax pregnancy registry from a physician concerning a 21 year old Hispanic female pt with a negative varicella antibody on 02-JUN-1999 on 02-JUN-1999 and a negative serum pregnancy test on 08-JUN 1999 who was vaccinated with a first and second dose of varicella virus vaccine live on 11-JUN-1999 (Lot #1656H) and on 08-JUL-1999 (Lot #1656H), respectively. Concomitant therapy included prenatal vitamins. On 16-JUN-1999, the pt had MRI to evaluate the lumbar spine. There was some concern as to whether on not there was x-ray exposure during pregnancy. Therefore, at the time of vaccination pt was 1 month pregnant. EDD 05-MAR-2000. Follow up info from a physician reported that on 11-JUL-1999 an ultrasound was performed and the results were normal. On 28/DEC-1999 a repeat ultrasound was done which indicated polyhydramnios and large for dates. It was also noted that from 15-FEB-2000 to 24-FEB-2000 the pt was placed on amoxicillin 500 mg for the treatment of otitis media and bronchitis. On 27-FEB-2000 the pt delivered a healthy girl, weighing 8 lbs and 9 oz's. There were no congenital anomalies or complications during pregnancy. The rest of the info on this record is about the baby's well check visits and everything is normal U 07/08/1999 12/28/1999 173 Diagnostic laboratory on 06/02/1999 =negative varicella antibody; mri on 06/16/1999 consisting of lumber spine series (possible x-ray exposure during pregnancy; an ultrasound done on 07/11/1999 was normal; and ultrasound done on 12/28/1999 showed polyhydramnios. Beta-human chorionic on 06/08/1999 was a negative serum pregnancy test. A beta-human chorionic on 07/15/1999 was a positive urine pregnancy test. UNK UNK vitamins irradiation exposure during pregnancy WAES99071153 1
0172275 06/01/2001 OH 30.0 30 F 05/29/2002 Information has been received form a physician through the pregnancy registry for varicella virus vaccine live concerning a 30 yr old Caucasian female pt with a penicillin allergy (which caused a rash) who on 28-JAN-1999 was vaccinated with one dose of varicella vaccine live (site unknown). The pt learned that she was pregnant. The pt had no illnesses at the time of vaccination or during her pregnancy. Medical records indicated that during the pt's pregnancy she experienced a low lying placenta at 18 weeks. a repeat ultrasound was done and the pt's experience resolved. On 18-MAR-2000 the pt delivered a normal, healthy baby girl whose weight was 8 lbs. Moderate shoulder dystocia was noted during delivery however the pt's total labor time was 7 hrs and 6 minutes No further information is expected Y 06/28/1999 10/25/1999 119 ultrasound done on 03/07/2000 was within normal limits; no abnormalities seen; another ultrasound done on 10/25/1999 was also within normal limits. OTH OTH UNK Medical Hx: Rash NOS; Concurrent conditions: Pregnancy NOS (LMP = 06/17/99); Penicillin allergy WAES99080483 1
0172276 06/01/2001 WI 35.0 34 F 05/15/2001 Information has been received through the pregnancy registry for varicella virus vaccine from a physician concerning a 35 year old Caucasian female with a herniated disc who on 21-MAY-1999 was vaccinated with one dose of varicella virus vaccine live (site unknown). On 03-AUG-1999 the pt learned that she was pregnant. An ultrasound was done on 16-DEC-1999 was within normal limits-normal growth/no abnormalities. Illnesses noted during pregnancy included conjunctivitis and the flu. The pt took acetaminophen and hydrocodone bitartrate (vicodin) from 20-APR-2000 to 21-APR-2000 for the herniated disc. On 03-MAY-2000 the pt delivered a healthy baby boy . Results of the newborn screening panel were all normal at the time of delivery. The rest of the text content has to do with the infant and Dr visits for him Y U 05/21/1999 05/08/2000 353 Ultrasound on 12/16/1999 was within normal limits-normal growth/no abnormalities OTH OTH vicodin herniated disc WAES99091106 1
0172277 06/01/2001 PA 28.0 28 F 05/15/2001 A 29 yr old Caucasian female who on 29-JUL-1999 and 14-SEP-1999 was vaccinated with the first and second dose of varicella virus vaccine live (site unknown. The pt became pregnant. Information received from a physician through a Merck pregnancy registry. In follow up the pt had routine pregnancy tests, all normal. An ultrasound done on 25-FEB-2000 was also normal. On 27-JUN-2000, the pt delivered a healthy, normal female birth weight 9 lbs and 6 oz. The rest of the text refers to the infant's visit to pediatrician for routine checkups and normal baby illnesses. Y U 09/14/1999 OTH OTH UNK WAES99110045 1
0170509 06/04/2001 GA 1.0 1 .0 F 05/21/2001 On 5/9/01, approx. 23 hours, post vax, she began to vomit continuously. She does not go to daycare and had not been around any sick people. She vomited approx. every 5 minutes and refused anything per mouth. She did not have a fever after the 2nd time she vomited. I arrived at her pediatrician's office about 20 minutes after this started and she was running a fever of 102F (she has never run a fever this high before) and her color was a greenish/white. She was lethargic and her breathing was very rapid. Her pediatrician told us to go straight to the ER. She was still vomiting and listless and her eyes were rolling back in her head. She was choking when she was trying to vomit. She had to receive fluids at the ER through IV, as she was dehydrated. She was released approx. 6 hours later, after having IV for 4 hours. It took 45 minutes and 2 sites to start the IV. Rubber banks were tied around her upper arms to prepare each arm for the IV (to check veins). Then again tied to draw the blood for the blood work. These bands were on her injection sites from the day before, making this procedure extremely painful. Her fever stayed at 102F for 1 day. She still tried to vomit for 4 days. She stayed weak for about a week and an half. The blood work at the hospital showed no evidence of an infection-normal WBC. It only showed that she was dehydrated. As far as we know at this time, she has recovered. Y Y Y 05/08/2001 05/09/2001 1 Blood work - no evidence of infection. Normal WBC. Dehydration. PVT PVT NONE NONE NONE 1
0170510 06/04/2001 NJ 55.0 55 F 05/18/2001 The pt woke up on 4/22 with severe pain and numbness in both hands, unable to close hand to make a fist, fingers very difficulty to move. Could not feel objects in hand, pain remained excruciating, went to the ER. MD could not make a diagnosis, was admitted to continue testing. Treated with Percocet and then high doses of ibuprofen. Neither gave relief. Discharged on Vioxx for 3 weeks, no help, symptoms persist. The 60 day follow-up states that there is still some intermittent, minimal numbness in the three middle fingers of the left hand and middle finger only of the right hand, only at finger tipps and only occasionally. Y Y 3 N 04/03/2001 04/22/2001 19 Magnesium, uric acid and calcium levels; Rheumatoid Factor; ANA; Cryoglobulin; Lyme titer-all results WNL PVT OTH Effexor SR NONE NONE 1
0170513 06/04/2001 MN 1.6 1 .6 F 05/31/2001 The pt experienced hives, swelling of the face and wheezing. Treated with epinephrine, prelone, Benadryl, admitted to the hospital. Y Y 05/31/2001 05/31/2001 0 PVT UNK NONE Resolved otitis media 1
0170515 06/04/2001 IL 0.21 0 .2 M 05/29/2001 According to pt's grandmother, the pt, who came in last May 8th, the child was apparently brought to ER, several days, post vax. The child who eventually transferred to hospital and subsequently, to a rehab center. No other information available, at this time. Diagnosis: hypovolemic shock, sepsis. Follow up: Ischemic brain injury; status post presumed meningoencephalopathy; interstitial nephropathy; sick-swallow incoordination. Y Y U 03/13/2001 PVT PUB Oral Nystatin Rx given on 3/13/01. Mild oral thrush NONE 1
0170516 06/04/2001 NY 0.3 0 .4 M 05/25/2001 The pt experienced a fever one day post vax of 102.6, hives, irritability noted in the middle of the night. Tylenol brought fever down. Y Y 09/27/2000 09/28/2000 1 NONE PVT PVT NONE NONE NONE 1
0170517 06/04/2001 MA 0.2 0 .2 M 05/25/2001 No data provided. Y 05/25/2001 05/25/2001 0 NONE PVT PUB NONE NONE NONE 1
0170518 06/04/2001 GA 1.6 1 .6 M 05/25/2001 The child had the vaccine on 5/15/01. Was presented to the clinic today complaining of fine rash on back, arm, feet, hands and neck. Had a fever 1 day post vax. Y 05/15/2001 05/18/2001 3 PUB PUB NONE NONE NONE 1
0170519 06/04/2001 MA 0.5 0 .5 F 05/22/2001 The pt experienced significant red blotchy rash over body especially trunk and upper extremities. Diagnosed with hives. Treated with Benadryl. Y 05/16/2001 05/16/2001 0 NONE PUB PUB NONE 1
0170520 06/04/2001 NC 2.0 2 .2 M 05/23/2001 The pt received the Prevnar Vaccine on 5/21/01. Reported to the doctor who observed 3 x 3.5cm area of erythema and warmth on upper left arm. No tenderness was noted. Y 05/21/2001 05/23/2001 2 NONE MIL MIL NONE allergy to Amoxicillin, Cephalexin NC01051 1
0170521 06/04/2001 GA 28.0 27 M 05/29/2001 The pt experienced a 1/4" diameter subcutaneous cyst at location of vax. Cyst present since immunization. N 04/20/2000 04/20/2000 0 NONE MIL MIL NONE NONE NONE 1
0170539 06/04/2001 MA 4.0 4 M 05/25/2001 The pt received vax on 5/22/01 in left arm. Was seen in office on 5/24/01 with diagnosis of cellulitis at the injection site. The area was 18 x 14 inches with redness. Treated with Augmentin. Seen on 5/25/01 and the area had improved. Y Y 05/22/2001 05/24/2001 2 NONE PVT PUB NONE NONE NONE 1
0170540 06/04/2001 VA 4.0 4 M 05/25/2001 The pt experienced left thigh induration, triangular formation on thigh with redness over entire area with induration. Y Y 05/16/2001 05/16/2001 0 NONE PVT PVT NONE left serous otitis NONE 1
0170541 06/04/2001 CA 4.2 4 M 04/26/2001 The pt experienced fatigue, fever, erythematous papular rash, central vesicles with itching for 2 days. Clinical illness consistent with mild varicella. Y 07/15/1997 04/26/2001 1381 PVT OTH NONE NONE NONE 1
0170542 06/04/2001 NC 4.0 4 M 05/21/2001 The pt experienced left thigh swelling, redness, raised area with a small rash radiating to groin area. The pt complained of the area itching. Mother gave the child Tylenol every 4-6 hours. Benadryl and compresses were also used. Y 05/16/2001 05/16/2001 0 PUB PUB NONE NONE fetal hydronephrosis, asthma NC01052 1
0170543 06/04/2001 TX 71.0 71 F The pt experienced a 3 x 3 red, raised, hot area. Y 04/16/2001 04/22/2001 6 PVT PVT NONE NONE 1
0170544 06/04/2001 VA 36.0 35 U The pt experienced hives, spots on chin within 3-4 minutes of vax. The pt complained of stiffness on left side beginning 1/2 hour post vax for 30 minutes. Y 05/14/2001 05/14/2001 0 NONE PVT OTH Tylenol NONE NONE 1
0170545 06/04/2001 AZ 10.0 10 M 05/21/2001 The pt experienced a fever of 102 and shortness of breath, which started approximately 2 1/2 hours post vax. This resolved spontaneously. Y Y 02/20/2001 02/20/2001 0 NONE OTH PUB NONE NONE NONE 1
0170546 06/04/2001 NJ 1.4 1 .4 M 06/01/2001 The pt's mom noticed a rash starting on 5/23/01. Saw the doctor on 5/24/01. The pt experienced an intense macular erythematous papular rash on face, chest, arms, back and mildly on legs. Education and reassurance was given by the doctor regarding the possibility of a reaction to the MMR vaccine. Treated with Benadryl for the itching. Y Y 05/11/2001 05/23/2001 12 PVT UNK NONE NONE NONE 1
0170547 06/04/2001 NC 10.0 5 M 06/01/2001 The pt experienced a rash 48-72 hours post vax. On 6/1/01 after a sunburn the rash appeared again in the same place. The left shoulder had a vesicular rash with erythematous base. U 02/02/1996 02/04/1996 2 viral culture PUB PVT NONE NONE NONE 1
0170548 06/05/2001 NV 0.8 F 05/15/2001 On 4/25/01, telephone call from mother, stating child seen by doctor on 4/25/01 concerning body rash which started on calf X 3 days. Also, had "flu-like" symptoms; blistery rash at site of HIB & Hep-B (RD). Doctor dx'd "5th venture", per mom. Discussed soothing methods; Benadryl, Tylenol and soothing bath. On 5/15/01, mom called stating rash covered body and had increased coughing and increased crying. Child was hospitalized X 1 day for observation. Y Y 1 Y 04/25/2001 PUB PUB NONE NONE None NV0103 1
0170549 06/05/2001 SC 1.0 1 .0 F 05/23/2001 Presented on 5/22/01 with seizures and transported to medical college, children's medical center and admitted by pediatric neurology. Dx'd with seizure and placed on Depakote. Y 4 Y 05/14/2001 05/22/2001 8 EEG-abnormal PVT PVT NONE NONE 1
0170552 06/05/2001 NC 1.3 1 .3 F 06/01/2001 The pt experienced redness, swelling in left thigh with a fever lasting 2-3 days. Gave warm compress, Tylenol, Motrin, Keflex, and Zyrtec. U 05/30/2001 05/31/2001 1 PVT PUB NONE NONE 1
0170553 06/05/2001 CA 0.5 0 .5 M 05/31/2001 The pt experienced an urticarial rash which developed 5 days post vax. Y 04/10/2001 04/15/2001 5 PVT PVT NONE NONE 1
0170554 06/05/2001 IL 2.0 2 .0 F 06/01/2001 The pt experienced a local erythematous reaction with pruritis on the right shoulder area. No generalized reaction. U 05/30/2001 05/31/2001 1 PUB OTH NONE heart murmur 1
0170555 06/05/2001 NV 1.3 1 .4 M 05/14/2001 The pt experienced a fever, swelling and redness to the thigh. Treated with Tylenol as needed and warm compresses to area. U 05/10/2001 05/11/2001 1 NONE PVT PVT NONE NONE NONE NV0106 1
0170556 06/05/2001 NC 1.75 1 .7 M 02/28/2001 The pt was given the vaccine on Monday. He had mild shakes the next day, and had a slight temperature. He was irritable until the Sunday of the same week. After Sunday he was back to normal. Y 01/22/2001 01/23/2001 1 PVT PVT Tylenol NONE NONE 1
0170557 06/05/2001 NV 1.0 1 .0 F 05/11/2001 The pt experienced redness, swelling, RAT, treated with Advil, Benadryl, cool compresses. U 05/09/2001 05/11/2001 2 NONE PVT PVT NONE NONE NONE NV0104 1
0170558 06/05/2001 MN 1.2 1 .2 M 05/30/2001 On 4/19 Mom called and stated the child had a fever, cough and was fussy. On 4/20 saw the doctor with a diagnosis of probable viral bronchitis. Albuterol syrup, O2 saturation was 96 %, chest x-ray suggested interstitial pneumonitis. On 4/23/01 office visit the pt still had a fever, cough, was now wheezing, dry mouth, slightly depressed fontanel. Was started on Amoxicillin. On 4/27/01 varicella injection site has erythema and a small vesicle, fever is down and dehydrated with improvement. Y Y 04/13/2001 04/19/2001 6 Chest x-ray - interstitial pneumonitis PVT PUB NONE NONE 1
0170559 06/05/2001 FL 1.0 0 1 M 05/22/2001 1-2 weeks post vax, the pt broke out with pos greater than 100. No fever associated. Instructed in treatment for chicken pox. U 05/09/2001 05/21/2001 12 NONE PVT PVT NONE NONE NONE 1
0170560 06/05/2001 TX 3.0 3 M 04/18/2001 No data provided. U 04/10/2001 04/12/2001 2 NONE PVT PUB NONE runny nose 1
0170561 06/05/2001 TX 5.0 5 M 04/18/2001 The pt experienced erythema 3-5 cm with induration. U 04/10/2001 04/12/2001 2 NONE PVT PUB NONE cough and phlegm URI 1
0170562 06/05/2001 TX 4.0 4 M 04/18/2001 The pt developed erythema at the site which was 3-5cm with induration. U 04/10/2001 04/12/2001 2 NONE PVT PUB cough and sore throat URI 1
0170563 06/05/2001 MI 1.08 1 .1 M 05/25/2001 The pt experienced a rash on the face, back, abdomen, a runny nose, saw the doctor on 5/25/01. Y U 04/17/2001 05/25/2001 38 PVT PUB resolving otitis media 1
0170564 06/05/2001 OH 0.5 0 .5 F 05/25/2001 The pt experienced a red, swollen injection site which had a hard, pea sized lump. Y 05/24/2001 05/25/2001 1 NONE PVT PVT NONE NONE ~DTaP (no brand name)~1~0.20~In Sibling 1
0170565 06/05/2001 IA 0.3 0 .3 M 05/22/2001 The pt experienced a fever several hours post vax, crying, hard to console, and jerking in sleep. The fever was 101.3 at the office exam. CNS irritability with fussiness and crying with little manipulation and very temporary calming only with usual comfort measures. Y Y 03/28/2001 03/28/2001 0 PUB PUB acetaminophen NONE NONE 1
0170566 06/05/2001 FL 7.0 7 M 05/26/2001 The pt experienced a varicella like rash (erythematous maculo-papular) developed around the injection site seven to ten days post vax. Also developed pruritis, soreness and redness around the injection site. Treated with Augmentin and Acyclovir. Y Y 05/11/2001 05/20/2001 9 NONE PVT PUB Singulair, Claritin, Albuterol NONE asthma 1
0170567 06/05/2001 PA F 05/31/2001 Following the third dose of Lymerix, the pt experienced arthralgia. As of 5/24/01, the outcome of the event was unknown. U OTH OTH 20010130161 1
0170568 06/05/2001 MD 66.0 F 05/31/2001 A few days post vax, the pt "felt like crap". This feeling resolved. On 3/20/00, following the third dose she began experiencing bilateral upper arm weakness, pain in back of knees with weakness, general weakness from knees to ankles with tender spots, constipation and diarrhea. As of 5/24/01, the outcome of the events was unresolved. N 03/20/2000 OTH OTH Tylenol, Potassium, Pravachol, Levothyroid, Vioxx 20010130361 1
0170569 06/05/2001 FL 42.0 40 M 05/25/2001 The pt experienced itching and swelling to the left arm which was twice the normal size. Follow up: Patient recovered from adverse event. Patient is on full duty. Patient received further shots since reported event, the events were: swelling and itching of arm." Y Y 06/04/1999 06/04/1999 0 MIL MIL NONE NONE NONE 1
0170570 06/05/2001 SC 16.0 16 M 05/16/2001 The pt experienced swollen, erythematous, tender injection site 12 hours post vax. Y Y 12/05/2000 12/05/2000 0 PVT PUB Zyrtec, Singulair, Zithromax, Albuterol, Intal 1
0170571 06/05/2001 SC 7.0 7 F 05/31/2001 The pt experienced a swollen, erythematous and tender injection site occurring 12 hours post vax. Y Y 11/28/2000 11/29/2000 1 PVT PUB Claritin, Singulair, Intal, Volmax NONE allergies, asthma 1
0170572 06/05/2001 SC 15.0 15 M 05/16/2001 The pt experienced swollen, erythematous and tender injection site, which occurred 12 hours post vax. Y 02/21/2001 02/21/2001 0 PVT PUB Palmicort, Albuterol, Intal, flonase, Ceftin, Allegra, Singulair 1
0170573 06/05/2001 SC 11.0 11 M 05/16/2001 The pt experienced swollen, erythematous and tender injection site which occurred 12 hours post vax. Y Y 11/21/2000 11/22/2000 1 PVT PUB Volmax, Augmentin, Vioxx, Zantac, Claritin, Singulair, Zoloft, Ceftin nasal allergies 1
0170574 06/05/2001 FL 0.3 0 .3 M 05/23/2001 Vaccinated on 4/24/01, on 4/7/01 developed Urticarial rash with lesions resembling erythema multiforme on 4/28/01. Treated with steroids antihistamines, eventually seen in ER/ID consult and referred to allergist. Y Y 04/24/2001 04/27/2001 3 None PVT PUB Tylenol None None 1
0170591 06/05/2001 OR 14.0 14 M 05/30/2001 Upset stomach - 18 hrs post vaccine. Fever 12 hrs later increased 3 degrees- resolved in 2-3 days. emesis-few episodes. Y 05/10/2001 05/11/2001 1 PVT UNK None noted ADHD pt on Ritalin 1
0170592 06/05/2001 OR 1.02 1 .0 M 04/26/2001 Dx chicken pox 4/25/01 - Dr. Benadryl for itching. Y 07/24/2000 04/25/2001 275 PUB PUB None None OR200122 1
0170593 06/05/2001 OR 5.0 5 F 04/26/2001 Chicken pox 4/16/01, rash times 1 month improving papules with vesicles on trunk and extremities. 4/27/01 ears hurting - cough - new outbreak rash - has MD appointment today, @ 4:15P. Rash began 6 weeks ago. Y 08/11/2000 PUB PUB None No NO OR200123 1
0170594 06/05/2001 CT 1.5 1 .5 F 05/16/2001 Right arm swelling, with 7cm of erythema and induration T 100.9 developed about 18 hours post vaccine. Y 05/14/2001 05/15/2001 1 PVT UNK None None 1
0170595 06/05/2001 VA 4.0 3 M 06/01/2001 Warm reddened, itchy area on right deltoid from top of shoulder to approximately 1 inch below deltoid. Y 05/13/2001 05/31/2001 18 PVT PVT None 1
0170596 06/05/2001 VA 1.0 1 .0 M 05/30/2001 Developed 6x8 cm area of erythema and swelling in left thigh 24 hours post vaccine. Y U 05/29/2001 05/30/2001 1 None PVT PUB None None 1
0170597 06/05/2001 NY 1.25 1 .3 F 05/29/2001 Well child received immunization 5/11/01. On 5/13 temp of 101. On 5/14 had febrile seizure with T 105 in ER. WBC 8.3, cultures neg. No sigh of infection. Erupted 1 tooth on 5/16/01. Y 05/11/2001 05/14/2001 3 WBC 8.3 differential not available. PVT PUB None Well child None 1
0170598 06/05/2001 NC 37.0 37 F 05/30/2001 On evening of 5/28/01 pt noticed redness, pain, and swelling at injection site L deltoid, redness was about size of a baseball. Over the evening hours she began to have pain in her neck and bad headache during the overnight hours. Pt states she awoke 6 or 7 times because of aching in joints, especially in hips and ankles. Presented at clinic at 17:00 on 5/29 - aching in joints had decreased but headache neck pain weakness continued. Y Y 05/27/2001 05/28/2001 1 None PVT PVT Premarin Laceration L hand None 1
0170599 06/05/2001 WA 5.0 5 F Developed large 3" swelling over. Y 05/04/2001 05/04/2001 0 PVT PVT Allergy SX runny nose 1
0170600 06/05/2001 TX 1.25 F 05/29/2001 Pt with history of R thigh mass times 2 weeks, received May 3, 2001 2 shots over week increased nodule now mass no redness or discharge 1x2cm in size. Previous reaction in Nov 2000, requiring surgery. U 05/02/2001 05/29/2001 27 R thigh abscess MIL MIL NO NO 1
0170601 06/05/2001 NJ 5.0 1 .2 F 05/29/2001 Varicella Lesions on torso (had received Varivax from previous MD) Y Y 09/24/1996 05/25/2001 1704 OTH OTH None Chicken Pox~Polio Virus, Oral (no brand name)~1~5.00~In Patient 1
0170602 06/05/2001 OH 2.9 2 .9 F 05/29/2001 Hives several hours after receiving vaccine on 4/30/01 Y 04/30/2001 04/30/2001 0 NONE PVT PVT None None None 1
0170603 06/05/2001 NJ 37.0 37 F 05/30/2001 Received # 1 dose of Hepatitis A 5/29/01. Had no itching all day, got home @ 8PM and removed her slacks discovering hives on inner aspect of both thighs and a few on outer thighs, this is the only place she had hives. She did not take any antihistamines and ignored hives and on awakening 5/30/01 noticed hives had disappeared. On Synthroid 100 mcg daily only. Y 05/29/2001 05/29/2001 0 OTH PVT Synthroid 100 mcgm daily. Last week on Amoxicillan finished on 5/25/01 None Hyperthyroidism 1
0170604 06/05/2001 MI 1.25 1 .3 M 05/25/2001 Seen 5/17/01 - c/o temp 103, (teething) drooling, no vomiting good activity - sick 4 nights prior, seen 5/13. Motrin - stops temp then return when went off. PE: was ?, (B) jaw tender Y Y 04/30/2001 NONE PVT PVT NONE Congestive heart disease (VSD used 12/01) 1
0170605 06/05/2001 MI 5.0 5 M 05/24/2001 Swelling of upper arm with extensive redness (about 5") from shoulder to mid arm, tender to touch Y 05/21/2001 05/22/2001 1 PVT PVT None None 1
0170606 06/05/2001 OH 18.0 18 M 05/29/2001 5/29/01 pt called with C/O hives on back and sometimes back of legs. Appeared about 3 days ago. Has taken nothing to relieve symptoms. Advised pt to try Benadryl cream topically or oral Benadryl. If symptoms increase see PMD or call. U 05/16/2001 05/26/2001 10 PUB UNK None None PCN, dust, animals (cat & dogs) ? 1
0170607 06/05/2001 VA 6.0 6 F 05/29/2001 Redness swelling began with blisters localized to R thigh around shot site, approximately 4cm diameter circle lesions various sizes. Infection secondary to itching site. Y U 05/14/2001 05/23/2001 9 None PVT PVT None None None ~Varicella (Varivax)~1~4.00~In Sibling 1
0170608 06/05/2001 UT 0.7 0 .4 F 05/30/2001 Parent reports that pt began having difficulty breathing in evening of immunization, became pale, also developed fever that night - was taken to Snowcreek ER clinic next day - treated with nebulizer. parent did not tell MD of immunizations the day before. Y Y 02/07/2001 02/07/2001 0 PUB PUB No NO 1
0170609 06/05/2001 AR 2.0 2 .1 M 05/10/2001 Localized redness hardness at L upper deltoid sit of vaccine. Dx otitis media, URI 5/10/01. Y 05/08/2001 05/08/2001 0 PUB UNK AR0125 1
0170610 06/05/2001 NJ 4.0 1 .1 F 06/01/2001 The pt developed chicken pox. The pt had the vax on 1/12/1998. Y 01/12/1998 06/01/2001 1236 NONE PVT PVT NONE NONE 1
0170611 06/05/2001 NC 7.0 1 .6 M 05/31/2001 The pt experienced a varicella infection, 5 lesions on face, 3 on back, several on buttocks, one on chest, one on scalp. Lesions are in various stages. Infected lesion on back treated with Bactroban. Y U 07/10/1995 05/31/2001 2152 PVT OTH UNK UNK 1
0170612 06/05/2001 NV 4.0 4 M 05/11/2001 The pt experienced left arm redness, swelling 48 hours post vax. Treated with cool compresses, Advil and Benadryl. U 05/09/2001 05/11/2001 2 NONE PVT PVT NONE NONE NONE NV0105 1
0170613 06/05/2001 UT 1.0 1 .0 M 05/29/2001 The pt experienced hives on 2/5/01. Y 02/05/2001 02/05/2001 0 NONE PVT PUB NONE NONE eczema 1
0170724 06/05/2001 MD 32.0 M 05/30/2001 Following vaccination, the pt experienced no immunity to mumps. U diagnostic lab test - no immunity to mumps UNK UNK UNK allergy to dust, pollen, ragweed and asthma WAES00121836 1
0170725 06/05/2001 40.0 F 05/30/2001 The pt had a negative rubella titer. The pt sought unspecified medical attention. It was also noted the pt experienced product confusion on 1/5/01 with measles virus vax. Additional information has been requested. Y U diagnostic lab test - neg rubella titer OTH OTH NONE NONE WAES01010442 1
0170576 06/06/2001 NY U 05/30/2001 Information has been received from a physician who reported that she had received a telephone call from an obstetrician. The obstetrician indicated that his child was vaccinated with Hep-B vaccine recombinant (yeast) and died of sudden infant death syndrome (SIDS). Since that time, the obstetrician had started a web site of Hep-B vaccine recombinant (yeast) and SIDS cases. The obstetrician reported that he had 40 cases (WAES 01050372) in his web site. The physician also reported that an infant vaccinated with Hep-B vaccine recombinant (yeast) developed cyanosis, jaundice, vocal cord damage and gastroesophageal reflux disease (WAES 01042680). Y N OTH OTH UNK UNK WAES01052519 1
0170577 06/06/2001 CA 0.2 0 .2 M 05/25/2001 The child developed a fever and irritability post vax. Continued taking a bottle however. The child improved on 5/4/01 and mother thought symptoms resolved. Child placed down for a nap at 10:00PM on 5/4/01. 2 hours later the child was discovered apneic with vomitus. Autopsy states cause of death as probable suffocation. Child taken to hospital in full cardiac arrest. Y 05/05/2001 N 05/03/2001 05/05/2001 2 Autopsy-pending PVT PVT NONE NONE Hospitalized for pneumonia as neonate (2/16/01 through 2/23/01) 1
0170578 06/06/2001 NJ 47.0 47 F Follow up information was received from a nurse practitioner. Medical records were received as part of litigation proceedings. Additional information was received from a newspaper reporter. In 1977, the patient began to experience discomfort in her legs. Atrophy of the lateral aspect of her right thigh was noted. Although she is left handed and left side dominant, her left thigh was smaller than her right thigh. The physician stated, "Lesion may be bilateral." The physician recommended consideration of electromyelogram, exercise, and weight loss. Surgical history included two full-term cesarean sections and tubal ligation. The subject's mother had "similar ankle problems involving Achilles tension and very probably had enteropathic arthritis." On 05/04/1999, the patient received her first 30-mcg injection of LYMErix (Lot: LY104A2). Approximately one to two weeks later, the patient reportedly experienced joint pain in her hips, knees, and ankles; flu-like symptoms; ankle edema; swollen feet; a viral syndrome; and stiffness (NOS). She "could scarcely walk up and down stairs." The patient reported that she saw a rheumatologist and underwent unspecified blood tests and x-rays. The patient stated that the rheumatologist said she had "reactive arthritis". On 05/20/1999, the subject was seen by her primary care physician. The medical record noted that the subject had experienced +1 ankle edema: "possible reaction to LYMErix vaccine." The subject's medications were celecoxib (Celebrex) 100mg twice daily and nabumetone (Relafen) 750 mg twice daily. The subject was referred to a rheumatologist. On 05/27/1999, the infectious disease specialist wrote a letter to a nurse which stated that the patient presented now with arthralgia and myalgia. "The subjects history is significant in that she received a Lyme vaccine on 05/04/1999 and subsequently developed polymyalgia and arthralgia predominantly of the knees and ankles...Physical examination (revealed) no other demonstrated muscle tenderness or joint swelling or redness." The rheumatoid factor was negative. "At the time her problems include: 1. Polyarthralgia/mylagia. 2. Recent vaccination with Lyme vaccine. Recommendations: 1. Check pParvovirus, Ehrlichia and Eabsia titers and smear for Babesia. 2. Repeat Lyme EIA (enzyme immunoasay) and Western blot. On an adverse event form received by the manufacturer at an unknown date, the reporting nurse stated that the patient reported on her 05/20/1999 physician visit that she had experienced joint pain, joint swelling and viral syndrome approximately two weeks after receiving LYMErix. On 06/02/1999 the subject was seen by the physician. She had experienced a rash which affected her entire body. All medications were discontinued. On 06/09/1999, the subject was seen by the rheumatologist. The medical record noted that the subject had received an injection of LYMErix on 05/04/1999 and "subsequently developed diffuse myalgia and arthralgia...knee and ankle with dependent swelling. On 05/31/1999, she developed a facial rash round red extended to arms, trunk resolved after five days. 05/20/1999 placed on celecoxib (Celebrex) helped pain not swelling andles and Achilles. Three days ago developed red, nodular erythema hips." Physical examination revealed both Achilles tendons tender and swollen, right greater than left ankle swelling, knees and hips normal. Impression: asymetric....oligoarthritis....Doubt reaction to Lyme vaccine." Medical records from the patient's gynecologist and gyneoendocrinologist indicated that the patient was complaining of multiple arthralgias on 05/06/1999. Antinuclear antibody titer and rheumatoid factor measured on 05/17/1999 were negative. The patient had elevated eosinophils 7.4% (normal 0-5%), elevated monocytes 600/cubic millimeter (normal: 0-590/cubic millimeter), and elevated globulines 3.4 gm/dL (normal: 1.3-3.4 gm/dL). On 05/27/1999, Lyme IgG/IgM ratio was 1.34 (positive 1.10 or greater). The symptoms were treated with an anti-inflammatory (NOS), steriods, celecoxib (Celebrex( 100mg twice daily for 1.5 weeks, and nabumetone (Relafen) 750mg every 12 hours. On 06/02/2000, the subject was seen by the rheumatologist. The subject never had the lab work or x-rays performed. She did take Voltarun and Azulfidine. The medications seemed to help her symptoms. "Everything hurts. Sleeps well, wakes rested. No joint swelling. Stiff AM all over improves with activity. " "Like I have the flu". Better after shower. Three weeks ago tick bite. (Received) 10-day (course) of clarithromycin (Biaxin). Impression: FMS (fibromyalgia syndrome), previous problems seem to have resolved. On 06/11/1999, the rheumatologist summarized his findings in a letter to the subject's primary care provider. "On examination, she has tenderness of both Achilles tendons and they are swollen, not at the insertion, but in their mid portion. She has asymmetric swelling of the ankles, the right more so than the left. Bith andles are painful to flex and extend. The right ankle is somewhat warm. She has nodular tender skin areas over the right head of the fibula, the right calf in it's mid portion and over the left anserine tendon. There are no knee effusions and the hips have a normal full range of motion. There is no pain. There is some tenderness over the left sacroiliac dimple. Interestingly, her mother , who is deceased from breast cancer, had Crohn's disease and had similar ankle problems involving the Achilles tendon and very probably had enterophathic arthritis. My working diagnosis at this juncture is that the subject has reactive arthritis, or at least, an undifferentiated spondyloarthopathy. The role that the Lyme vaccine plays in this is purely speculative....I am going to treat the subject as if she has reactive arthritis. I am going to start her on diclofenac sodium (Voltaren) 75mg twice daily. I am obtaining x-rays of her ankles to look at her Achilles tendons and her heels. I will also check her sacroiliac joints to see if there is any evidence of sacroilitits radiograhically. If sacroilitis is present radiographically, that would point to a more chronic subclinic proces that may have been activated due to some antigenic challenge. I think overall, her prognosis is good. Usually, reactive arthritis lasts for a period of three to six months." The Lyme Western Blot performed on 06/16/2000 was negative. Polymerase chain reaction testing revealed that the subject was HLA-DR4 negative. On 06/28/2000, the subject was seen by the rheumatologist. "PMS (fibromyalgia syndrome), stressed, reuridic house, wakes one time pernight, Voltaren helps; labs negative. Impression: stress related symptoms. Sensitive Voltaren, add emitriptyline hydrochloride (Elavil)." On 06/26/2000, the subject called the rheumatologist to report that her hand stiffness had increased although she was sleeping well on Elavil 20 mg. She was seen by the rheumatologist. The medical record noted that "Hands feel swollen, do not look swollen; increased pain; complains of hot flashes; sleeps better. Plan: discontinue Voltaren, change to ibuprofen (Motrin); continue Elavil." Unspecified radiologic testing performed on 06/16/2000 revealed "Some narrowing of the right and left sacroiliac joint, more so on the right than left." On 09/20/2000, the subject was seen by the rheumatologist. The medical record noted that "The patient was off Elavil; sleeps OK; pain bad. Plan: try adding cyclobenzaprine hydrochloride (flexeril) at hour of sleep." On 09/25/2000, the subject was seen by the rheumatologist. The medical record noted "increased pain over sides of hips, hurts to sleep on side. Plan: discontinue Motrin; try codeine 300mg every 6 to 8 hours." The information received on 01/31/2001 did not provide an outcome. In a news article published 06/25/2001, a reporter stated, "The stiffness and swelling has become so severe that she is dependent on anti-inflammatory drugs to keep her mobile." The patient stated, "I just keep moving. It doesn't get rid of the pain, but it keeps me from stiffening." The outcomes of the flu-like symptoms and viral syndrome were not reported. On 02/11/2002, in a Statement of Injuries, her attorney alleged that the vaccinee "sufferes from 'severe' joint pain and stiffness." The most recent information, received on 10/31/2002, did not provide the outcomes of the reported events. The adverse event of "reactive arthritis" does not meet ICM serious critieria, but is being submitted as an expedited report by special request per the 06/28/2000 letter. The annual follow up received on 6/19/02 states, " I have not been well since I had the LYMErix vaccine. This past winter I was finally diagnoseed with Epstein Barr and some type of autoimmune arthritis and now I have to go see doctor because I am experiencing memory loss, confusion and difficulty concentrating. Y Y N 05/04/1999 05/06/1999 2 Eosinophils, Blood: 7.4%; Globulins: 3.4 mg/dL; Lyme antibody screen: 1.34; Monocytes, Blood: 600/cu mm; Rheumatoid factor: Negative; Antinuclear antibody screen: Negative, including anti-centromere; Lyme Western Blot IgG: Negative; Lyme Western Blot IgM: Negative; Polymerase chain reaction: MLA-DR4 negative; Unspecified radiologic testing of the sacroiliac joints: Conclusion: some narrowing of the right and left sacroiliac joint, more so on the right than left." PVT PVT Biaxin (Roxithromycin + Clarithromycin) NONE Agitated Depression, Allergic Bronchitis, Allergy to PCN, Anxiety, Arthritic pain, Atrophy of thigh, cardiac murmurs, ceserean section, depression, flu-like symptom, fluid retention, headache, insomnia, lateral epicondylitis, leg pain, lumbosacral sprain, premature ventricular beat, premenstrual syndrome, sciatica, tubal ligation. Medical history included reactive depression (1980), insomnia (1980), "continuous headache" (1985), acute lumbosacral strain (1983), acute agitated depression (1985), anxiety reaction (1986), allergic bronchitis (1989), lateral epicondylitis resistant to nonsterioidal anti-inflammatories (1990), premature ventricular contractions (1997), unspecified heart murmur (1997), lumbar strain with sciatica (03/15/1999), severe premenstrual syndrome, fluid retention, penicillin allergy, family history of rheumatoid arthritis, arthritic pain in fingers and knee caps when taking megestrol (Megace) and spironolactone/hydrochlorothiaride (Aldactaside) in 1987, and flu-like symptoms while dating Aldactaride in 1987. Aldacatride was discontinued on 06/04/1987. In 1977, the patient began to experience discomfort in her legs. Atrophy of the lateral aspect of her right thigh was noted. Although she is left-handed and left-side dominant, her left thigh was smaller than her right thigh. The physician stated, "Lesion may be bilateral." The physician recommended consideration of electromyelogram, exercise, and weight loss. Surgical history included two full-term cesarea sections and tubal ligation. The subject's mother had "similar ankle problems involving the Achilles tension and very probably had enteropathic arthritis." 1
0170581 06/06/2001 FL 5.0 5 M 05/24/2001 Itching and sore left thigh area. Y Y 05/21/2001 05/21/2001 0 UNK UNK NONE NONE 1
0170582 06/06/2001 FL 0.2 0 .2 F 05/29/2001 Pt clinically well, received routine 2 month vaccines at 10:00 on 5/25/01. Pt returned with mom with history of: went limp, at mall, ? stopped breathing, no resuscitation required at mall. Mom shook pt and she was well after about 30 seconds. Repeat exam at 12:30 was WNL. Referred to ER for further evaluation. Y Y 2 Y 05/25/2001 05/25/2001 0 Work-up was negative PVT PVT NONE NONE NONE ~Vaccine not specified (no brand name)~~0.20~In Sibling 1
0170585 06/06/2001 RI 1.08 1 .1 M 05/30/2001 Information has been received from the CDC concerning a 15 month old male who at 10 months old, developed failure to thrive with his growth and development going from 90th percentile down to 10th percentile. A work-up at that time was unremarkable. On 2/23/01, the pt was vaccinated with 1 dose of Varicella virus vaccine live. It is unknown whether concomitant vaccinations were administered. On 4/13/01, the pt was hospitalized for a varicella-type rash. He received 3 days of acyclovir therapy and also 3 days of IV antibiotics because of possible infective lesions. He was discharged to home on erythromycin; however, on 5/2/01, he was readmitted to the hospital with approx. 1,000 varicella-type lesions throughout his body. It was reported that new crops were developing and there were bullous lesions on his hands and feet. A chest X-ray showed a defuse nodular pattern which the physician felt was compatible with varicella pneumonia. His heart rate and respirations were increased but he had not been placed on the respirator. A DFA staining of a skin lesion was positive for VZV virus. A CSF processed in an outside lab was positive for varicella zoster virus using PCR technology. The CDC has received a skin lesion crust but has not identified any varicella zoster virus. It was noted that the pt has a negative family history of immunocompromised disorders and he is HIV negative. Additional information has been requested. Y Y U 02/23/2001 04/13/2001 49 CXR on 5/2/01-defuse nodular pattern c/w varicella pneumonia; Diagnostic Laboratory 05/01/01 -DFA staining was positive for VZV virus; deoxyribonucleic acid 05/01/01 -PCR of CSF (+) for VZV; 5/2/01 vital sign 05/02/01-HR and RR "increased; deoxyribonucleic acid 05/01/01 - pcr done by cdc (+) wild type VZV OTH OTH UNK Failure to thrive WAES01052466 1
0170614 06/06/2001 NY 0.3 0 .3 F 05/17/2001 No data provided. Y U 05/15/2001 05/15/2001 0 PVT PUB NONE NONE 1
0170615 06/06/2001 SC 0.8 0 .8 M 05/29/2001 The pt experienced a fever of 100.7 at 10:00 PM on 5/25/01. The pt was taken to the ER. All blood work was normal. The pt returned home on 5/29/01. No problems are evident now. Y U 05/25/2001 05/25/2001 0 PUB UNK Reglan, Zantac Tetrology of Fallot, Hyperbilirubinemia, hydronephrosis, hypospadias 1
0170616 06/06/2001 UT 0.5 0 .5 M 05/31/2001 Tonic-clonic seizure-like activity which occurred once an hour period (6 or 7 times), lasting only 5-10 seconds. Occurred during a fever of at least 102F (R). Y Y 05/29/2001 05/30/2001 1 NONE PVT PVT NONE NONE 1
0170617 06/06/2001 NY 0.8 M 06/07/2001 The pt experienced swelling in the right thigh. Treated with warm compresses. N 01/28/2001 x-ray - soft tissue changes and edematous changes PUB PUB NONE NONE 1
0170618 06/06/2001 IL 0.6 0 .5 F 05/10/2001 Developed "knots in both legs where you gave the shots". Over the next 2 weeks, she had a fever, "off and on". The highest temperature was 102F. She then developed "little bumps" on her face and it spread to her legs and arms. The "rash" developed and turned red in the last couple of days. Hasn't been seen by a doctor yet. Referred to clinic and has appt at 14:15 on 5/14/01. On 5/17/01, telephone call to mother reports seen by physician and rash was believed to be related to heat. "knots" should go down. Y Y 04/23/2001 04/25/2001 2 PUB PUB NONE IL01020 1
0170619 06/06/2001 MI 0.3 0 .4 F 05/29/2001 Vaccines administered on 5/22/01. That evening she started running a fever >101F (ax). Mom gave Tylenol q 4 hours, until afternoon of 5/23/01. Afebrile afterwards. Had 1st seizure at 07:30 AM on 5/24/01; was nursing, stopped and "body shook" then went stiff and eyes rolled. Lasted about 1 minute. 2 other similar episodes prior to 09:00AM. Went to ER. I saw pt on 5/29/01 and her exam is entirely normal. Her mother said that on 5/24/01, she was quite sleepy and inactive. By the next day, she was back to normal. Her mother denied extensive crying, irritability or bulging fontanel at the time. ER found her afebrile and no focal signs nor signs of meningeal irritation. (I talked to ER physician on 5/24/01). I don't have lab values from ER visit. Perhaps her family physician will have these. Y Y 05/22/2001 05/24/2001 2 EEG on 5/29/01-nml for age; Head CT scan on 5/24/01-normal non-contrast; labs done on 5/24/01-electrolytes, Cr, glu, Ca, Mg, al PVT PUB NONE NONE NONE 1
0170620 06/06/2001 MN 2.0 2 .0 F 05/31/2001 Immediately upon being injected, pt cried frantically. She continued for >45 minutes, despite ice and po acetaminophen. Left office awake. After about 1 hour, post vax, sleeping fitfully with slightly tender knot of 2cm on the left anterolateral thigh, previous identical reaction, lasted 2 days, then pt recovered. Y U 05/31/2001 05/31/2001 0 PVT PVT Pulmicort 5/31/01 NONE Allergy to morphine (welt with skin test) Crying for >45 minutes;sleeping fitfully with tender knot at injection site~Pneumo (Prevnar)~1~1.50~In Patient 1
0170621 06/06/2001 SC 0.6 0 .6 F 05/31/2001 Routine immunizations administered on 5/29/01. Seizure activity on 5/30/01, cared for by EMS. Rechecked in office on 5/30/01. Treatment: observation, Tylenol every 4 hours, fluids and rest. Y U 05/29/2001 05/30/2001 1 PVT PUB NONE Possible URI Positive for RSV on 2/13/01 1
0170622 06/06/2001 0.3 0 .3 M 05/15/2001 DTAP, Comvax, Prevnar and IPV administered in Immunization Clinic at 09:00 on 5/15/01. Pt cried inconsolably for 6 hours afterward. Normal exam. Treated with 2 doses of Tylenol and didn't help. Finally fell asleep at 15:00. Y Y 05/15/2001 05/15/2001 0 NONE MIL MIL NONE NONE NONE 1
0170623 06/06/2001 TX 1.4 1 .4 M 05/28/2001 Redness and swelling to left thigh. No fever. No systemic reaction. Y Y 05/25/2001 05/27/2001 2 UNK UNK NONE NONE NONE 1
0170624 06/06/2001 40.0 40 M 01/10/2001 Noted intense arthralgia at hips, knees, elbows, shoulders and thoracic spine with swelling of right shoulder joint and left knee. Onset within 24 hours of injection. Currently using Motrin for symptoms. Evaluated pt 1 week, post vax, and is still with symptoms. N 01/04/2001 01/04/2001 0 MIL MIL NONE NONE NONE 1
0170625 06/06/2001 GA 46.0 46 F 05/22/2001 11/2/00, sudden onset of severe vertigo and nausea, lasting 6 hours and lingering for several days. On 11/6/00, sudden onset severe vertigo and nausea, lasting 10 hours and lingering several days. Saw ENT MD on 11/7/00 and was prescribed valium and rest. I had follow-up with MD ENT on 11/17/00. I continue to have frequent periods of mild motion sickness and periods of feeling off balance. Y N 10/26/2000 11/02/2000 7 PUB UNK NONE NONE NONE 1
0170626 06/06/2001 FL 76.0 F 05/23/2001 I am listing all of the doctors we have been to and I will start with our family doctor who is an Internal Medicine doctor where I had the worst symptoms. He had a neck X-ray and an MRI of the head and brains to rule out that area of real concern. Then I went to a Gastroenterologist and had a gastroscopy and Endoscopy. Then I went to an Infectious Disease doctor and then I went to a Rheumatologist. After all of the doctors and all the tests were completed; all were negative. This all started on 12/01/00, when my wife and I went to MD for our Flu shot at 08:30 AM and at 18:00PM, that night, I started and the next day my wife started with the same symptoms I had. At that time we were both eating roast duck which we bought at a public store. These ducks came pre-cooked and frozen (you just cook them for 45 minutes). We had been eating them for some time. When we went to buy more they stated the store had a recall on them. After a time of being sick, I asked the store manager what the recall was for. He checked and could not find what the cause was, for the recall. We tried to think what we both done and the only thing was the Flu shot and the duck where there was a recall on them. I wonder if you and your associates could please help us if possible to get to the bottom of this nightmare. It has been hell on earth with all the symptoms of violent headaches (both front and rear), sore muscles, raw stomach, dry mouth, metallic test in the mouth and we feel like we are dehydrating with all the water we are drinking, runny nose, perfuse sweating and neck pains. I thank you people for anything you can do for us and will do whatever it takes. Y N PVT PVT Synthroid 0.075mg NONE Hypoglycemia 1
0170627 06/06/2001 FL 76.0 76 M 05/23/2001 Generalized aches and pain, headache, profuse sweating, dry mouth, increased thirst, metallic taste, beginning on the evening of shot. He had eat some roast duck that had a recall and a flu shot as well as his wife, and they both had the same symptoms and he wants to know if there is a connection with the food or the flu shot that is still causing them both to be sick. Follow up on 08/08/2001: "Patient believes to have a reaction to a flu shot that he received this past December. Since his shot, he has experienced headaches, "sweating", and "burning" in his stomach. He apparently has been extensively worked up by another MD, ID, and rheumatology without determining any cause for his symptoms. This includes dry mouth, sore gums. He has myalgias. He states that his eyes feel swollen. He is fatigued and he also has trouble with "songs running through the mind." His weight has been stable. He has been afebrile. There has been no skin rash and workup thus far has been unremarkable. Simple blood tests and an MRI scan of the brain have been normal. He has not tried any specifiec therapy and he only takes symptomatic therapy for his headaches. This does not at all seems like a reaction to a vaccine, although he seems to date the onset to that time. This is not typical for a vaccine reaction and it in fact is not typical for anything that I can think of. Nevertheless, it seems persistent and the patient claims that he was doing well prior to it. At this point, initial evaluation has been unremarkable to establish a diagnosis. Perhaps it is possible for a vaccine to trigger an autoimmune of other type of reaction, although that does not seem to be the case here either. In any case, the patient does not seem to be deteriorating since his weight is stable and his laboratory studies have been okay. At this point we will pursue the evaluation to make sure we are not over looking anything more serious. Y N 12/12/2000 12/12/2000 0 Neck X-ray; MRI of head and brains; Gastroscopy; Endoscopy; Rheumatology check; Infectious Disease check-all nml; Cortisol PM: 10.2; ESR: 3; MRI of cervical spine; PVT PVT Carafate, Coumadin, Endoet, Alternagel, Prevacid, Temazapam, Vitamins NONE Prostate Ca in remission, Demerol, IVP dye, Colonoscopy (05/22/1998): mild proctitis; EGD (05/22/1998): Status post nisson Fundoplication-Clo (-); Decreased hearing; Stomach surgery in 1950's for ulcer disease, Degenerative heart disease; Prostate cancer, status post radical prostatectomy followed by radiation and Lupron, followed by MD. 1
0170628 06/06/2001 GA 45.0 44 F 05/25/2001 Vertigo-8 days; dizziness with headache-30 days. U 10/26/2000 11/11/2000 16 UNK UNK NONE NONE 1
0170629 06/06/2001 MA 31.0 30 M 05/30/2001 Approx. 5 minutes, post vax, pt developed cough, profuse diaphoresis, pulse increased to 100, numbness and tingling in jaw/teeth. Given 0.3cc of epinephrine on right thigh, 911 ambulance/EMT's took pt to hospital. Rx'd IV Benadryl and some other medication. Pt cannot remember none of the other medications that he was given at the hospital. Pt had complete and uneventful recovery. Y Y 11/28/2000 11/28/2000 0 NONE OTH OTH NONE NONE NONE 1
0170630 06/06/2001 MA 13.0 13 M 05/31/2000 Mother of pt called into MD's office on 5/30/01 to report pt had reaction to injection. Had injection at 16:00 and at approx. 19:30, had difficulty to breathe, hard time to take breath in. (Pt has history of allergy, but stated it wasn't that). Was light-headed. On 5/30/01, in the AM, pt vomited and had a headache. When parent reported it, it was 15:00 on 5/30/01. Per parent, pt is now better. No local reaction at injection site. Tolerated 2 other Hep-B vaccines, well. Y 05/29/2001 05/29/2001 0 NONE PVT PUB NONE Eczema/Environmental allergies 1
0170631 06/06/2001 WI 2.0 0 1 F 05/31/2001 Facial spots; greater than 10 lesions. N 08/13/1999 05/31/2001 657 PVT PVT NONE NONE NONE 1
0170632 06/06/2001 UT 3.0 3 M 05/24/2001 Pt is a 3 1/2 year old male who presents today for symptoms of urticaria. He received a varicella vaccination during a visit to the office on 5/15/01. He broke out in urticarial rash later that afternoon and this has become gradually worse over time. Mother has not given him anything yet for this. He has not been exposed to any other medications. He is not on any OTC or RX medications. He is on no alternative medication. Pt has had no previous immunization reactions. He is not allergic to medications. Has not had any hospitalizations. Pt had the injection administered in the right anterior thigh. Exam: NAD. He said that his rash "tickles". Urticaria reaction with wheal and flare response over the extremities and buttocks. Very little involvement of the trunk or the face. Lungs are clear. No crackles or wheezes. Pharynx is nml. Neck supple. Lungs and heart are clear. Abdomen is soft without tenderness. Dx: acute Urticarial reaction. Suspect reaction to varicella vaccine. Will use Benadryl and/or Atarax as needed for urticarial reaction. I have advised mom to try and keep him cool. Use Tylenol for minor itching. If he should become worse a follow-up visit is indicated. Otherwise, careful exposure to eggs and egg based vaccines in the future. Y Y 05/15/2001 05/15/2001 0 NONE PVT PVT NONE NONE NONE 1
0170633 06/06/2001 WA 2.0 2 .0 F 05/30/2001 Rash under left arm, 2 weeks, post vax. U 05/07/2001 05/21/2001 14 PVT PUB 1
0170634 06/06/2001 CA 1.0 1 .0 M 05/30/2001 Erythema Multiforme; onset 13 days, post varicella vax. Initial lesion over vaccine site. Y Y 05/08/2001 05/13/2001 5 PVT PVT URI, OM NONE 1
0170635 06/06/2001 HI 45.0 45 M 05/14/2001 Low-grade fever of 100F, body ache, headache and taste change. U 05/09/2001 05/11/2001 2 BP-159/89; T-98.8F; Exam-+ occasional wheeze on lung fields (pt is a smoker) PVT PVT NONE Peanut allergy 1
0170636 06/06/2001 VA 4.0 4 F 06/01/2001 Pt received 4 year vaccines; DTAP in upper left deltoid; Polio injection, SC, and MMR in right arm. Pt had redness and swelling at site of DTAP, measures 2" X 3" and a dime-sized bruise. Y 05/29/2001 06/01/2001 3 NONE PVT PVT NONE NONE 1
0170637 06/06/2001 TX 15.0 1 .3 M 05/29/2001 Redness, mild swelling 3" in diameter on right mid-thigh, minimal warmth without fluctuance, 48 hours, post vax of Trihibit. RX: Augmentin but doubt cellulitis. Y Y 05/24/2001 05/26/2001 2 PVT UNK Benadryl prn NONE 1
0170638 06/06/2001 WI 5.0 5 M 12cm by 10cm area of erythema and warmth on left biceps area. Y U 05/29/2001 05/29/2001 0 PVT UNK 1
0170639 06/06/2001 WA 4.0 4 F 05/25/2001 Swelling at the site of injection with redness and swelling of the area causing limping when walking. No temperature. Y Y 05/23/2001 05/23/2001 0 PVT PUB NONE 1
0170640 06/06/2001 SC 4.0 4 F 05/31/2001 Routine immunizations administered 5/29/01. Onset of elevated temperature (>104F), weakness, shaking and complaint of eyes hurting on 5/30/01. Y 05/29/2001 05/30/2001 1 NONE PVT PUB NONE NONE 1
0170641 06/06/2001 MD 34 F 05/18/2001 Rash developed on legs and body several hours after shots given. No other Symptoms. Rash described as red, papular without itching, no fever. Otherwise feeling well. No specific therapy U 05/16/2001 None UNK UNK 1
0170642 06/06/2001 AZ 2.0 2 .4 M 05/29/2001 Pt seen in ER 5/27/01 per mom for ? vaccine/allergic reaction or cellulitis R elbow to shoulder- per vaccine administrator DPAT and Varivax were given R arm- Has been on Keflex times 2 days. Much less red and swollen today. Dr aware. Follow up on 10/25/02: "From mailed correspondence received on 08/27/01 it was reported, "Reviewed no additional information at this time. This case is closed." Y Y 05/25/2001 05/27/2001 2 PVT PVT Finished Amoxil 5/25/01 NO NO 1
0170643 06/06/2001 IL 4.0 4 M 06/01/2001 Swelling to L upper arm noted 24 hrs post shots, extended from elbow to shoulder on exam by MD 5/26/01, resolved slowly over 1 week. Y Y 05/24/2001 05/25/2001 1 None PVT PVT topical moisturizers eczema H/O reactive airway disease (last in 8/99)eczema limb swelling~DTaP (no brand name)~4~2.00~In Patient 1
0170644 06/06/2001 UT 1.0 1 .0 M 06/01/2001 Child started breaking out with lesions on 5/29/01, came into office on 6/1/01 for verification of varicella breakout. Y Y 05/09/2001 05/29/2001 20 PVT OTH None None None 1
0170645 06/06/2001 MN 16.0 16 F 05/25/2001 1-2 hrs after receiving # 3 TD, pt developed pain and swelling L arm, moving arm with difficulty. Ice applied - Temp 98, acetaminophen 2 tab given. Relatives notified. Y 05/22/2001 05/22/2001 0 OTH PUB Depo Provera 1
0170646 06/06/2001 OH 1.0 1 .0 M 05/30/2001 Immediately after administration of vaccine site became erythematous, 6cm in diameter. There were no reported late effects. Y 04/13/2001 04/13/2001 0 PVT PUB 1
0170647 06/06/2001 OH 0.3 0 .3 F 05/30/2001 On 2/26/01 Mom reported immunization site was red and baby had a fever. Was seen on 2/28/01, and dime size red area on skin under IPV site with area of induration 1x2cm beneath. No tenderness, baby happy. Temp not taken. Y 02/24/2001 02/26/2001 2 PVT PVT Glycerin suppository Allergic Colitis Allergic Colitis 1
0170648 06/06/2001 PA 5.0 5 M 05/29/2001 Mom describes golf ball size lump L deltoid noted 4 days post Dapt IM and IPV sc given L arm on 5/24/01. No streaks, hives or airway problems. Used caladryl for itching. Lump decreased to flat by 5/29/01. Y Y Y 05/24/2001 05/26/2001 2 PVT PVT Fluoride, Zyrtec NO Allergies: Sulfa 1
0170649 06/06/2001 GA 1.5 1 .5 M 05/25/2001 Pt's Mom noticed area to Rt upper leg swollen. When awaking on 5/25/01 in AM. Pt check at hlth dept at 2pm. Rt leg swollen from knee to hip area- no redness or heat to area. Y 05/24/2001 05/25/2001 1 PUB PUB 1
0170650 06/06/2001 IN 17.0 17 F 05/23/2001 Difficulty breathing, wheezing, paleness, weakness, dizziness, fainted, slurred speech, nose bleed and fever. Y 05/02/2001 05/02/2001 0 OTH OTH 1
0170651 06/06/2001 KY 25.0 25 F 05/29/2001 Red, swollen and painful 2cm X 3cm. Y Y 05/21/2001 05/22/2001 1 CBC; CMP; Sed rate PVT UNK 1
0170652 06/06/2001 IN 9.0 8 M 05/30/2001 Mom called to the clinic and stated pt had red rash/hives for 2-3 days, post vax. Denies pain and no fever. Y 03/06/2001 03/08/2001 2 PUB OTH NONE NONE 1
0170653 06/06/2001 CA 5.0 5 F 04/15/2001 The arm at site of injection, swelled up severely and was burning, red-hot. The ER administered Benadryl and topically with triamcinolone cream. Y 09/01/2000 09/02/2000 1 PVT PVT Tuberculin test/1 previously NONE NONE 1
0170654 06/06/2001 CA 1.7 2 .3 M 06/10/2001 5/10/01; increased fever of 105F, not reduced by Tylenol until the next day. (Cough, eye infection the following week). Went to ER at 20:00. 5/11/01; rash on upper left thigh in the afternoon and rash on right leg and left foot in the evening. Y Y 05/07/2001 05/10/2001 3 Normal PVT OTH NONE NONE NONE 1
0170655 06/06/2001 PA 1.5 1 .5 M 05/30/2001 9cm X 7cm area of erythema and induration <24 hours, post vax, at site of DTAP. Y N 05/29/2001 05/29/2001 0 NONE PVT PVT NONE NONE NONE 1
0170656 06/06/2001 MI 4.0 4 M 05/29/2001 9cm X 16cm red, warm area. Onset on 5/15/01 PM, quarter-sized. On 5/16/01, it was egg-sized and an area of hives. On 5/17/01, it was orange-sized. Placed on antibiotic therapy. Y Y 05/15/2001 05/15/2001 0 PVT PUB NONE NONE 1
0170657 06/06/2001 NY U Shingles 4/01. Typical dermatitis type rash on right chest wall. Y Y 08/18/1995 04/01/2001 2053 UNK UNK 1
0170658 06/06/2001 AL 51.0 51 F 05/28/2001 Vaccinated 5/17/01 with TD adult in right deltoid. Developed increased redness and swelling and was placed on Medrol dose pack on 5/24/01. Y 05/17/2001 05/20/2001 3 PVT PVT NONE Hypercholesterolemia, borderline anemia, lumbar disc disease 1
0170659 06/06/2001 34.0 34 F 05/10/2001 The pt experienced a migraine due to neck and shoulder pain, temp of 38.5-39.8 Celcius in the (Ear), shivers, pain in whole body, sharp pain within left side of rib cage. Received cortisone shot. Y Y 05/01/2001 05/01/2001 0 MIL MIL PPD NONE allergy to fragrance, pollen, dust, nickel, and hay-fever 1
0170660 06/06/2001 MN 1.25 1 .3 M 05/29/2001 12 hours post vax, the pt developed areas of local irritation, redness at the vax site which occurred on both upper thighs. The left thigh was 3 x 2 inches, and the right thigh was 1 inch. No cellulitis was noted. Y Y 05/24/2001 05/24/2001 0 PVT OTH NONE NONE 1
0170661 06/07/2001 MD 0.3 M 06/05/2001 Information has been received on 5/30/01 concerning a 4 month old male received his second dose of DTAP, HIB and IPV. One week, post vax, he developed thrombocytopenia. A dx of thrombocytopenic purpura was made. Platelet count was 11,000 cells/mm3. He recovered. This event was considered "Medically Important". Y Platelet count-decreased 11000 (cells/mm3) test range unknown OTH OTH UNK UNK UNK HQ1572501JUN2001 1
0170662 06/07/2001 TX M 06/05/2001 An attorney alleged that a male child received 9 doses of vaccines containing thimerosal from 10/96 to 10/98. It is alleged that, as a result of the cumulative toxicity of the thimerosal contained in those vaccines, the child suffered and "in the future will continue, to suffer, from the toxic neurological effects of mercury poisoning." UNK OTH OTH UNK UNK UNK HQ1536301JUN2001 1
0170693 06/07/2001 ND 5.0 5 F 05/15/2001 This child had paralysis of the left arm after OPV. The annual follow up states that the vaccine recipient continues to have the same symptoms from the condition previously reported-dense weakness of left arm, no change or no increase in symptoms. Y Y N 08/26/1999 08/30/1999 4 Multiple tests PVT UNK NONE NONE NONE ND9927 1
0170694 06/07/2001 WA 1.4 1 .4 M 06/01/2001 24 hours post vax, the pt experienced a large area of redness and swelling which spread across the thigh approximately 11 1/2 x 6 cm. Pt was very irritable and ran a fever. Swelling starting to decrease. Y Y 05/29/2001 05/30/2001 1 MIL MIL NONE NONE NONE 1
0170695 06/07/2001 1.7 1 .7 F The pt developed a fever of 99.8, was irritable for 5 days. Y 04/16/2001 04/16/2001 0 NONE OTH PUB NONE NONE NONE 1
0170696 06/07/2001 ND 4.0 4 F 05/15/2001 Mother called to report that the pt had a reaction to the vax. She noticed swelling of the left thigh injection area. There was a large red area that was hard and the size of a grapefruit. She called the ER and was instructed to apply ice. There was no decrease in the swelling. Ther was no fever. The MD thought the swelling was cellulitis related to the DTAP vax U 05/11/2001 05/12/2001 1 PUB PUB NONE NONE allergy to Pediacare ND0104 1
0170697 06/07/2001 CA 1.25 1 .2 F 06/01/2001 The pt experienced a rash at the injection site than spread over both legs, abdomen, developed urinary infection. Not sure if UTI was related to vaccine. Fever was 103. Y Y 04/04/2001 04/14/2001 10 Urinalysis PVT PVT NONE NONE ~Varicella (Varivax)~~0.40~In Sibling 1
0170698 06/07/2001 OH 35.0 35 F 05/30/2001 The pt experienced a 4x5 cm area of erythema at the vax site. Elbow and shoulder joint pain with localized pruritus. Y 05/25/2001 05/26/2001 1 PVT PVT NONE NONE allergy to tetanus vaccine 1
0170699 06/07/2001 KY 4.0 4 M Mother states the pt woke up one day post vax with red raised area on top of the leg around the vax site, was also red, hot to the touch. Pt was given Atarax in ER on 5/26/01. Y Y 05/25/2001 05/26/2001 1 PVT PVT NONE allergy to Zythromax KY2001039 1
0170700 06/07/2001 KY 37.0 37 F 05/23/2001 The pt complained of extreme redness approximately 4 inches in diameter around the injection site with edema from site to wrist area. Pain at the site and down arm to wrist. Still has pain in right arm 8 days later. Pt complained of site hot to the touch. No drainage from site. Y 05/15/2001 NONE PUB PUB PPD NONE NONE KY2001038 1
0170701 06/07/2001 OH 17.0 17 F 06/05/2001 15 minutes post vax, the pt "didn't feel well" and was dizzy. She collapsed to the floor, was unresponsive, but respirations and pulse were ok. Face was pale but cyanotic. She experienced eye twitching with eyes rolling and then bilateral upper extremity stiffening and jerking. She then became alert. Y 06/05/2001 06/05/2001 0 observation PVT PVT PPD, ortho-tri-cyclen NONE NONE 1
0170702 06/07/2001 FL 72.0 72 F 06/07/2001 24 hours post vax, the pt experienced a progressive local erythema, tenderness, induration and heat with headaches which lasted 3 days. Y U 05/24/2001 05/25/2001 1 PVT UNK 1
0170703 06/08/2001 CA 3.0 3 M 06/06/2001 An MA reported that a 3 year old male with NKDA and no past medical history who on 05/17/01 was vaccinated in the upper thigh with a first dose of hepatitis A virus vaccine inactivated. The concomitant vaccine was Prevnar, which the pt received in the opposite upper thigh. It is not known which vaccine was given in which thigh. The pt had no illnesses at the time of the vaccinations. On 05/25/01, the pt. was unable to walk and was seen by a physician. The physician did a right hip x-ray that yielded a negative result. On 05/25/01, the pt. was sent to an orthopedic clinic and evaluated by an orthopedic surgeon. The orthopedic surgeon ordered a right hip ultrasound. The ulrasound reported a right hip effusion. On 05/25/01 an arthocentesis was performed. The physician did not think that the right hip effusion was related to vaccinations, but the orthopedic surgeon thought the effussion was the result of the vaccine, not necessarily the injection or technique of administration. It was noted that the child was treated and released from the hospital on 05/25/01. During a phone followup with the mother of the child, it was reported that the child recovered from his inability to walk. It was unknown if medication was ordered after the procedure. Upon internal review hip effusionn was determined to be an other important medical event. FOLLOW-UP information has been received from a HCP which indicated that she was unaware of any changes regarding the patient's status. FOLLOW-UP information recived on 11/13/2001 from a physician indicated that no further information was available concerning the patient. No further infornmation is available. Y Y 05/17/2001 05/25/2001 8 5/01 Aspiration joint Follow up tests including radiograph of hips normal, ultrasound of hip was normal, CBC and sedimentation rate results were unknown. PVT PVT NONE NONE UNK HQ1644105JUN2001 1
0170704 06/08/2001 IL 0.13 0 .1 M 06/07/2001 Within 24 hours, the patient collapsed and was in a shock-like state, paramedics called and the child was improving. He was monitored over night at the hospital, no treatment, CPR and pulse ox used to monitor; the patient described as white colored and non responsive for 3-4 minutes. Y 1 Y 06/01/2001 06/01/2001 0 NONE PVT PUB NONE NONE NONE 1
0170705 06/08/2001 NJ 2.0 2 .2 M 06/05/2001 Child broke out in hives around injection site, this happened immediately. Dr gave Claritin, Pt monitored for 1 hr sent home and told to give Benadryl Q4. Y 06/04/2001 06/04/2001 0 PVT UNK 1
0170706 06/08/2001 IN 0.49 0 .5 M 06/01/2001 On 4/27/01 mother called with information on child reaction, child slept all afternoon of vaccine (2/28/01) had rapid heart rate, Temperature of 104 for approximately 30 minutes, Tylenol given and fever reduced child ok next day after vaccine given. Mother said she had written note from Dr that child should not receive any more Prevnar. Y 02/28/2001 02/28/2001 0 PUB PUB 1
0170707 06/08/2001 AL 0.72 0 .7 F 06/01/2001 Vaccine administered and mother left with the pt, approximately 45 minutes later the mother called and stated pt had hives all over. Dr ordered Benadryl PO q6hr. Y 06/01/2001 06/01/2001 0 PVT UNK 1
0170708 06/08/2001 ID 5.0 5 M 05/25/2001 Redness and tender from hip to knee around shot site. The follow up states child has developmental delays. Y 05/24/2001 05/25/2001 1 None PVT PUB ID01026 1
0170709 06/08/2001 ID 3.0 3 M 05/22/2001 Localized swelling entire thigh including knee, limp. Y 05/20/2001 05/20/2001 0 PVT PUB ID01025 1
0170710 06/08/2001 ID 4.0 4 F 05/07/2001 12cm x 7cm localized erythematous, induration patch. Y Y 05/01/2001 05/03/2001 2 None OTH PUB Zyrtex 5mg, Ibuprofen prn Allergic rhinitis None ID01023 1
0170711 06/08/2001 ID 1.6 1 .6 M 05/07/2001 Severe local reaction with redness, warmth, swelling of entire upper leg. Stiff in AM - hesitient to bear wt. Y 05/04/2001 05/05/2001 1 PVT PUB ID01021 1
0170712 06/08/2001 TN 1.08 1 .1 F 05/21/2001 Woke up @ 3am and was given tylenol for fever 103F, at 8am cried & screamed inconsolably until afternoon, about 6 hours according to mom. Had low grade fever on 5/20/01 and on 5/21/01 no fever. No history of redness or swelling of extremities or rashes. Y 05/18/2001 05/19/2001 1 PUB OTH TN01020 1
0170713 06/08/2001 MO 65.0 65 M 06/06/2001 Seen in office 5/30/01 with angioedema of lips, treated with Benadryl and Medrol dose pack Y Y 05/23/2001 05/24/2001 1 None PVT PVT Vioxx, Lopid, Gly?, FES04, Verapamil, ? None Sulfur, DM, HTN, increased TRG, Colon Ca 1
0170714 06/08/2001 WY 3.0 3 M 05/04/2001 Red swollen hard leg with red blotches throughout the upper leg. IPV & Hepatitis B vaccines given on (L) upper thigh on 5/2/01. U 05/02/2001 05/03/2001 1 PUB PUB None None WY200102 1
0170715 06/08/2001 CA 4.0 4 F 06/06/2001 7cm in length and width of redness painful to palpatation. Site left thigh. Claritin 10mg 3/4cc daily, Diprolene AF cream apply thin layer 2 x a day. Amoxil 200mg 1tsp. bid U 06/04/2001 06/05/2001 1 PVT PUB None None 1
0170716 06/08/2001 MI 4.0 4 M 06/06/2001 Urticarial rash secondary to DTAP preservative? L leg cool compresses, Benadryl. Y 05/30/2001 06/01/2001 2 None PVT PVT RAD 3/21/01 urticaral rash~DTaP (no brand name)~3~1.00~In Patient 1
0170717 06/08/2001 ID 5.0 5 F 05/04/2001 2 hrs after shots, spiked fever 103, nausea, emesis every 1 hr and hallucinations. Mom took child to doctors office - she was told it was the stomach flu, also C/O headaches Y 05/02/2001 05/02/2001 0 PUB PUB None ID01022 1
0170718 06/08/2001 ID 4.0 4 M 05/09/2001 Vomiting times 2 times today, weak 05/08/2001 05/09/2001 1 PUB PUB None None None ID01024 1
0170719 06/08/2001 CA 36.0 36 M 02/06/2001 Sudden onset of flu-like symptoms, to include high fever, severe cough, headache, muscle pains and extreme exhaustion. Doctor's visit on day three recorded fever still at 100. Severe cough and and chest pain/discomfort through day six including difficult breathing on day 1. Y Y 01/30/2001 01/30/2001 0 MIL MIL None None similar~Influenza (Seasonal) (no brand name)~~34.00~In Patient 1
0170720 06/08/2001 NC 1.5 1 .6 M 05/25/2001 The pt experienced a localized reaction to the right deltoid with 5-7cm erythema, and non-tender swelling. The child received vaccines on 5/23/01. Mother noticed the area this morning. Advised warm compresses. U 05/23/2001 05/25/2001 2 PVT PUB rash urticaria ~Vaccine not specified (no brand name)~1~3.00~In Sibling 1
0170721 06/08/2001 MD 18.0 18 U Vaccines administered @ 12:00, after checking out and going home pt returned and reported hives on both upper and lower extremities @ 12:45 (no swelling of lips, tongue, throat) administered benadryl 25mg IM, PO benadryl 25mg Q6 x 2 days. No further problem. Y 06/02/2001 06/02/2001 0 PVT PVT PPD placed also on 6/2/01 1
0170722 06/08/2001 MS 18.0 18 F 05/22/2001 5/19/01 rash developed on Rt leg - extended from ankle to mid calf. rash sore to touch had elevated temp of 102.7, the increased temp lasted until 5am. Continue to have rash on Rt leg. Y Y 05/15/2001 05/19/2001 4 PUB OTH Unknown None None MS01018 1
0170723 06/08/2001 TN 20.0 20 M 04/26/2001 The pt experienced drowsiness, chills, and myalgia. Y 04/17/2001 04/18/2001 1 OTH OTH TN01019 1
0171840 06/10/2001 IL 36.0 36 F 05/15/2001 The pt was seen in the Dr's office for left shoulder, neck and arm pain affecting th trapezius. She was prescribed Flexeril, Ultram, and Baclofen. On 10/24/2000 she was seen again for a rash that had developed at the injection site. It was noted that the Dr feels the pain in the shoulder and trapezius is related to the injection of the vaccine. Y Y 10/10/2000 10/20/2000 10 PVT PVT Celexa, Cardizem CD, Vasotec, Lasix, Humulin None Diabetes Mellitus WAES00102213 1
0171019 06/11/2001 SC 19.0 18 F 06/01/2001 On 05/31/2001 this patient's mother called to report that this patient came down with bacterial meningitis on 05/27/01. Y Y Y Y 10/02/2000 05/27/2001 237 Cultures show strain of bacteria to be Neisseria Meningitidis Group B OTH OTH NONE NONE NONE 1
0171020 06/11/2001 KS 0.6 0 .7 F 02/05/2002 A nurse reported that a 7 month old female received her 3rd dose of Prevnar and 2nd dose of Comvax on 03/27/01. On 05/05/01, she developed meningitis and bacteremia. She was admitted to the hospital. The reporter indicated that she reported this event to Communicable Disease, Reportable Diseases in Kansas. A copy of this report has been forwarded to Merck, manufacturer of Comvax. Follow-up received from the nurse on 06/06/01 indicated that the infant recovered from the meningitis; however, the mother of the infant states that her daughter has significant hearing loss in her right ear. F/U states that information was received from a nurse concerning a 9 month old female who on 3/27/01 was vaccinated IM in the left leg with a 2nd dose of Hib vaccine (lot 637874/1524K). Concomitant therapy included a 3rd dose IM in the right leg of Prevnar (474726). There was no illness at the time of the vaccination. On 5/5/01, the pt developed meningitis and bacteremia and was hospitalized. It was reported that a blood culture was done and was (+). It was noted that on 11/22/00 and 1/16/00, the pt received a 1st dose IM in the right leg (lot 473342) and a 2nd dose IM in the left leg (lot 473450) respectively of Prevnar. It was also noted that on 11/22/01, the pt received a 2nd dose Im in the right leg of Hib-Titer (lot 560903A). Follow-up information has been received from a health care professional who reports the pt had residual hearing loss, but she could not report on which ear or any other details. Additional info has been requested. Additional F/U has been received from a healthcare professional who reports there was profound hearing loss on the right side. Additional information has been requested. Follow-up received from the nurse on 06/06/2001 indicated that the infant recovered from the meningitis; however, the mother of the infant states that her daughter has significant hearing loss in her right ear. Follow-up info was received from the infant's primary care physician on 01/29/2002. The physician indicated that the infant was seen in the office on 05/11/2001 for follow-up to the hospitalization for pneumococcal meningitis and streptococcal septicemia. The infant was noted to have "profound deafness" in her right ear. Laboratory results from blood collected on 05/11/2001 revealed no growth at day 7 and a platelet count increased. A neurologic exam revealed no meningeal sings. Treatment included continuation of intravenous cefotaxime and acetaminophen. The pt was to be see by county health dept in September 2001 for a hearing test but did not show up for scheduled appointment. The physician reported that the family had not been compliant with his recommendations. As of 01/29/2002, he was unaware of the pt's location and believes that the family has moved away. Reported on 02/04/2003: A nurse from the public health clinic reported on 01-22-2003 that the child recovered but is deaf in the right ear and her left leg lags when she tries to run. According to the nurse, the mother stated that "the child's father and child are both carriers of Streptococcal meningitis." A copy of this report has been forwarded to Merck, manufacturer of Comvax. Y 7 N 03/27/2001 05/05/2001 39 Blood culture and CSF culture both positive; platlet count increased PUB PUB UNK NONE UNK HQ0768211MAY2001 1
0171021 06/11/2001 NY U 06/07/2001 Information has been received on May 15, 2001, from a consumer concerning her child (age and gender unspecified). Medical history was not provided. The patient experienced developmental delay (developmental delay NOS) due to mercury toxicity (metal poisoning) following immunization with Acel-Imune and Hib-Titer vaccines. The mercury toxicity was considered medically important. No further information was available at the time of this report. U UNK OTH OTH UNK UNK UNK HQ1686105JUN2001 1
0171022 06/11/2001 OH 0.2 0 .1 F 04/30/2001 The child received vax on 3/20/01. Developed a fever that night to 103. Was taken to ER and rests were done to rule out sepsis. Y Y 2 Y 03/20/2001 03/20/2001 0 CXR, UC, LP, CBC with diffs PUB OTH NONE nasal congestion NONE 1
0171023 06/11/2001 NC 1.0 1 .0 M 06/01/2001 The pt experienced idiopathic thrombocytopenia purpura which was diagnosed on 2/5/01. Y Y Y Y 01/23/2001 02/05/2001 13 Platelet count 9,000 PVT OTH NONE NONE NONE 1
0171024 06/11/2001 IL 2.0 2 .4 F 05/18/2001 The pt experienced localized erythema and swelling. Treated with antibiotics. diagnosis-- cellulitis Y Y 1 Y 05/15/2001 05/15/2001 0 X-ray; pt tissue study-cellulitis PUB PUB NONE NONE IL01019 1
0171025 06/11/2001 OH 0.2 0 .2 F 05/10/2001 The pt received vaccines on 5/8/01 and on 5/8/01 PM the pt developed fever, shaking episode and brought to the ER. The pt was admitted to rule out sepsis. Diagnosis was fever only. Y Y 2 Y 05/08/2001 05/08/2001 0 CBC, LP, UA, UC, blood culture PUB OTH NONE eczema born to 18 year old IDDM mom 1
0171040 06/11/2001 FL 1.25 1 .0 F 06/01/2001 The pt developed minor case of chicken pox with impetigo which was secondary. Y U 03/01/2001 05/30/2001 90 NONE PVT PVT NONE NONE hx of otitis media 1
0171041 06/11/2001 MD 0.3 0 .3 F 05/29/2001 The pt experienced a fever of 102, fussiness, high pitch screeching cry, vomiting, crying lasted for 3 hours. Y 05/18/2001 05/18/2001 0 NONE PVT PUB NONE NONE NONE 1
0171042 06/11/2001 OH 0.75 0 .7 M 05/30/2001 On 5/24/01 the pt was fussy in the PM with a fever of 104. The following AM seen in the office. Y Y 05/24/2001 05/25/2001 1 PVT PUB 1
0171065 06/11/2001 TX 1.25 1 .3 M 05/29/2001 Within 48 hours, the pt experienced a rash on his chest. He experienced 4 days of skin burning, diarrhea, an increase in eczema to cover all of body. He then experienced a spotted rash all over his face from day 8-14 post vax. No measles were determined. Doctor stated he was reacting to the vaccine and building antibodies. Y Y 05/11/2001 05/13/2001 2 PVT PVT acetaminophen NONE eczema, allergy to eggs 1
0171066 06/11/2001 UT 33.0 32 F 05/29/2001 Three days post immunization patient developed diffuse body aches, headaches, fever and joint stiffness. Four days post vaccine she noticed a rash on her feet, knees and hands. She tried over-the-counter ibuprofen without much significant improvement. She developed a sore throat. Pharynx was erythematous. Skin showed clusters of erythematous papules on the feet, knees and hands. Impression was arthralgias and rash secondary to MMR reaction. Patient was given Demerol and Vistaril in the emergency department. She was prescribed Naprosyn and Y Y 04/09/2001 04/12/2001 3 CBC wnl except for elevated monocytes. Strep A throat culture negative. Chest xray negative. Pulse 107, respiratory rate 30. OTH PVT Prozac, Diltiazem, vitamins PSVT scheduled for ablation 5/7/01 1
0171067 06/11/2001 FL 26.0 26 F 05/30/2001 On 5/15/01 patient developed pain in shoulder and feeling of heaviness in entire right arm. On 5/16/01, the pain continued in the shoulder and extended to neck and right occiput and trapezius was tender. She began having nausea and gagging. On 5/17 the nausea was resolving, but the pain continued in neck. She was treated with ibuprofen and heat. On 5/18 she had resolution of her symptoms. Y 05/15/2001 05/15/2001 0 None PVT PVT None None 1
0171068 06/11/2001 MA 1.7 1 .7 M 05/31/2001 Patient developed a large, erythematous, swollen area over injection site on left thigh. Y 05/23/2001 05/25/2001 2 None PVT PUB None Kleinfelter's syndrome, asthma 1
0171069 06/11/2001 CA 5.0 5 M 05/30/2001 Patient was noted to have a red lump at injection site immediately following injection. Ice was applied within 2 minutes. He was given Benadryl elixir 2 tsp po 15 minutes after injection. Y 05/30/2001 05/30/2001 0 None PVT OTH Pasteur PPD, lot number C10152AA, applied to left forearm on date of immunizations None None 1
0171070 06/11/2001 LA 20.0 20 F 05/31/2001 Patient developed erythema and swelling at injection site extending to shoulder and elbow lasting 3 days. Y Y 05/24/2001 05/24/2001 0 PVT PVT None Congenital spherocytosis 1
0171071 06/11/2001 MO 1.7 1 .7 M 06/01/2001 Patient developed a red, hard, "goose egg" located 1 finger width around injection sites which started 24 hours after injection. Warm and cold compresses were used without relief. Y 05/31/2001 06/01/2001 1 None PUB PUB None None None 1
0171072 06/11/2001 CA 4.0 4 M 05/29/2001 Patient developed redness and warmth to touch which went down half of his upper arm. U 05/21/2001 05/22/2001 1 None PVT PVT Connaught PPD, lot # C0150AA, applied to left forearm None None 1
0171073 06/11/2001 AZ 5.0 5 F 09/10/2001 Patient developed a 6cm x 12cm area of erythema, slight induration and warmth to touch on left thigh. She was treated with ice and observation Keflex 500 BID x 10 D if increased symptom. From mailed correspondence received on Aug 27 2001, it was reported, reviewed, no additional information at this time. This case is closed. Y 06/01/2001 06/02/2001 1 PVT PVT None None None U200100834 1
0171074 06/11/2001 NC 3.0 1 .1 M 06/09/2001 Patient developed shingles. Y 12/23/1998 09/25/2000 642 None PVT PUB None None Asthma 1
0171075 06/11/2001 ME 1.0 1 .0 M 06/04/2001 Patient developed redness the size of a silver dollar at site of Hib #4. On 6/4/01, the reddness was down to the size of a pea, and he was doing fine. Y 05/29/2001 06/01/2001 3 PUB PUB None None 1
0171076 06/11/2001 NC 1.0 1 .0 M 06/09/2001 Patient developed herpes zoster. Y 06/16/1999 02/14/2000 243 Tzanck prep by dermatologist PVT PUB None None 1
0171077 06/11/2001 21.0 21 F Patient developed itching and hives on arms and face with slight wheezing. She took Benadryl at home. Y Y 03/30/2001 03/30/2001 0 MIL MIL TB test None None 1
0171078 06/11/2001 TN 18.0 18 F 06/04/2001 Immediately, post vax, pt left the building and waited in car. Sharp pain started in heart, up neck and down right arm, up into head and down all through arm and fingers of right side. Felt breathing difficult. Felt like was going to die. Lasted 5-10 minutes. Muscles were sore over whole body for the rest of the day with accompanying headache. Y 06/01/2001 06/01/2001 0 PVT OTH PPD/Pasteur/C0619AA/ID/LFA NONE Pt is grossly obese 1
0171079 06/11/2001 GA 51.0 52 F 05/20/2001 Deep muscle pain in arm, neck, back and numbness at injection site. Treated with prednisone, Motrin and Tagamet. Seen in ER on 4/15/01 for same and chest pain. Y Y 04/12/2001 04/15/2001 3 MIL MIL NONE Hypertension 1
0171080 06/11/2001 FL 0.08 0 .0 M 06/04/2001 Three days post vaccination the patient developed a blister. The blister broke and the patient now has a 1cm diameter scar. N 05/26/2001 05/29/2001 3 None PVT UNK None None None 1
0171081 06/11/2001 CA 54.0 54 M 05/29/2001 Telephone call from pt several hours, post vax, complaining of "feeling hot" and states face flushed which started <30 seconds, post vax. At work and no access to a thermometer. Referred to PMD if symptoms persist. Telephone call to client by provider 2 hours later. Client states "flushed look" abated, denies pain, fever, vertigo or headache. Encouraged to see PMD and call clinic if symptoms recur. U 05/08/2001 05/08/2001 0 PUB UNK NONE NONE Penicillin allergy 1
0171082 06/11/2001 IL 3.0 3 F 03/23/2001 Mother called. Immunizations given on 3/20/01. The next day, left leg reddened approx. the size of a baseball and was warm to touch. The following day it had less redness but area was 2 times larger in size. Today, center is slightly red, white area around and outer area slightly red. Will see MD today, (Endocrinologist) and will let us know MD visit outcome. Y U 03/20/2001 03/21/2001 1 PUB PUB Nebulizer for asthma; albuterol and Intal NONE NONE IL01018 1
0171083 06/11/2001 AZ 0.8 0 .9 F 05/22/2001 5/17/01 at 09:00, right thigh has "red splotches" with "some" edema. Cold compresses applied by mom the afternoon of 5/16/01. Child also "guarding" right leg. 5/18/01, phoned mom, red color gone, small knot in right leg/thigh area. Afebrile both days with crying (high-pitched). Tylenol was recommended on 5/16/01. Y 05/16/2001 05/17/2001 1 PUB PUB NONE NONE NONE AZ0119 1
0171031 06/12/2001 ID 0.2 0 .2 F 06/07/2001 Immediate projectile vomiting, diarrhea, excessive sleeping, slight fever, tenderness in both legs and feet, staring for long periods of time. Shots were given Friday, 05/25/01, baby passed away Monday in her sleep, general lethargy 05/28/01. Autopsy gives cause of death as sudden infant death syndrome. Y 05/28/2001 N 05/25/2001 05/25/2001 0 autopsy - SIDS PVT PUB NONE blood in stool formula allergy, hemangioma diarrhea and crying and vomiting~Hep B (no brand name)~~0.00~In Patient|~Vaccine not specified (no brand name)~~0.00~In Sibling 1
0171032 06/12/2001 FL 0.5 0 .6 M 04/18/2001 This patient had generalized hives, fever of 105 for 24 hours after his shots. He was vomiting. He was very lethargic and the rash continued. Because of the severity of the reaction the pt was hospitalized. He was observed for 48 hours and then subsequently discharged and he never had any problem. In the past he has never had any adverse reactions to immunizing agents. Y 2 Y 03/19/2001 03/21/2001 2 blood culture, chest x-ray, urine cultures PVT PVT NONE NONE peaches, 1
0171033 06/12/2001 CA 3.0 M 06/07/2001 Report # 2001013861-1 described seizure-like activity in a "child" of unspecified age and gender who received Tetanus and Diphtheria Toxoids and Acellular Pertussis vaccine adsorbed (Infanrix). Allergies, medical history, and concomitant medications were not specified. This report was submitted directly to VAERS, also. On an unspecified date, the vaccine received a dose of Infanrix; it was not known whether the vaccinee had received previous doses of Infanrix. Subsequently, the vaccinee experienced "seizure-like activity". This report is considered SmithKline Beecham medically serious. As of 06/06/01, the outcome of the adverse event was unknown. Follow up on 07/105/2001: "A seizure in a 3.5 or 4 year old vaccinee. The vaccinee presented to the vaccine provider with no medical records, no possibility of obtaining medical records, and no known immunization history. Therefore, the vaccine provider began a complete immunization series. On follow-up, the reporter stated that the vaccinee had received an initial dose of tetanus and diphtheria toxoids and acellular pertussis vaccine ("different manufacturer") on Oct 12, 2000. Reportedly, the family stated that the vaccinee had a gastrointestinal illness (NOS) the day prior to vaccination, although he had no sym ptoms the day of the immunizations. On May 1, 2001, the vaccinee received the second 0.5 ml intramuscular dose of tetanus, diphtheria, adn acellular pertussis vaccine (Infanrix), the second 0.5 ml intramuscular dose of hepatitis B vaccine (brand unspecified), the second dose of 0.5 ml intramuscular dose of Haemophilus influenzae type b vaccine (brand unknown), the second 0.5 ml intramuscular dose of inactivated poliovirus vaccine (IPOL, Aventis Pasteur), a 0.1 ml intradermal dose of PPD (purified protein derivative) and the second does of 7-valent, pneumococcal conjugate vaccine (Prevnar, Lederle Labs). A "few hours" later, the vaccinee experienced a seizure and was taken to the local emergency room. All tests (NOS) performed at the emergency room were "negative". Seizure is considered GSK medically serious. The reporter indicated that the seizure was possibly related to Infanrix. The reporter also indicated that the seizure could be associated with possible mild dehydration. As of Aug 7, 2001 the seizure had resolved. As of 06/26/2001, the outcome of the adverse event was unknown." Y U PUB OTH Tuberculin PPD Allergies, medical history, and concomitant medications were not specified. This report was submitted directly to VAERS, also. Follow up information was received. Allergies were unknown. The vaccinee presented to the vaccine provider with no medical records, no possibility of obtaining medical records, and no know immunization history. Therefore, the vaccine provider began a complete immunization series. On follow-up, the reporter stated that the vaccinee had received an initial dose of tetanus and diphtheria toxoids and acellular pertussis vaccine ("different manufacturer") on 12 October 2000. The family stated that the vaccinee had a gastrointestinal illness (NOS) the day prior to vaccination, although he had no symptoms the day of the immunizations. 20010138611 1
0171034 06/12/2001 OH 0.2 0 .2 F 06/07/2001 Report # 200103753-1 described seizure-like activity in a two month old female who received Diphtheria and Tetanus Toxoids and Acellular Pertussis vaccine adsorbed (Infanrix) for prevention of Diphtheria, Tetanus, and Pertussis. The vaccinee had no known allergies or medical history. There was no illness at the time of vaccination. The vaccinee was delivered via a normal vaginal delivery at 38 weeks gestational age. On 06/04/01 at 17:30, the vaccinee received her 1st left thigh dose of Infanrix, in addition to a left thigh dose of Haemophilus B Conjugate (meningococcal protien conjugate) and Hepatitis B (recombinant) vaccine (Comvax, Merck) and a left thigh dose of inactivated Poliovirus vaccine (IPV) Aventis Pasteur). Three hours later, On 06/04/01 at 20:30, per the other, the vaccinee experienced "seizure-like" activity with staring and jerking movements; the infant was "sleepy-tired". The vaccinee was not blue per the reporter and was afebrile at this time. The vaccinee was transported to the hospital on 06/04/01 at 20:30 and was admitted. She had a fever at the time of admission to the hospital. She currently was still hospitalized. Unspecified treatment was performed on 06/06/01 (no results as of yet). As of 06/06/01, the vaccinee was still hospitalized. Follow up on 07/09/2001: "Febrile seizure. The vaccine provider has submitted this report directly to vaers. Jerking/shaking movements. She was not responsive to voice. On the way to the hospital, the infant had a "dusky spell". On arrival at the hospital, she was described as "normal, healthy alert infant". She was hospitalized for observation. She had a fever of as much as 102 degrees F two hours after admission. On 06/05/2001, the results were interpreted as normal. The diagnosis was febrile seizure. The vaccinee recovered without treatment was discharged from the hospital on 06/06/2001. The reporter stated that the febrile seizure was moderate in intensity and was possibly related to Infanrix. As of 07/02/2001, there were "no further problems at present." Y N 06/04/2001 06/04/2001 0 EEG - Pending PVT PUB 20010137531 1
0171036 06/12/2001 IN 48.0 48 F 06/08/2001 Within 1/2 hour the pt experienced flu like symptoms, has progressively gotten worse. Has been to many doctors. The pt has developed kidney stones, gall stones, weight loss, neurological disorders. The 60 day follow-up states, "since 05/08/1999 my entire immune system has been attacked. Results are kidney problems, bladder, ureter, chronic infections, blood abnormalities, memory loss depression, drastic unwanted weight loss, chronic muscle and joint pain, spasms, loss of muscle tone, deconditioning, irritable bowel syndrome, chest and rib pain, and arthritis and flu-like symptoms over my entire body, which has continually gotten worse since 05/08/1999. Y Y N 05/08/1999 05/08/1999 0 Reaction to Lyme vaccine. PVT PVT NONE back and neck problems 1
0171038 06/12/2001 KY 76.0 76 F 06/03/2001 This patient weighed 100 lbs. Tetanus booster no wound, was told booster would last 10 years. Symptoms were deep aching of all soft tissue, not in joint, but in soft tissue, but is in the muscles. Several appointments with doctors, but no real relief. Y U 02/20/2001 02/24/2001 4 Blood work - Neg. PUB OTH NONE NONE 1
0171043 06/12/2001 WA 1.0 0 1 F 06/04/2001 Lesions measuring 1 3/4cm x 2 1/2cm developed at site of injection 6 days after injection was given. Lesion was improving when seen 12 days post injection. 05/15/2001 05/24/2001 9 PVT PUB 1
0171044 06/12/2001 GA 2.7 2 .7 M 05/08/2001 Approximately 10 minutes post vax, the pt's mom noticed swelling of right eye, no respiratory distress noted. The child was crying, rubbing eyes. No obvious rash, over the next 5 minutes the left eyelid began swelling. Mom chosed to take the child to the local ER. Child was treated with Benadryl. Y Y 05/08/2001 05/08/2001 0 NONE PUB PUB NONE NONE tetrology of fallot with surgery on 8/98 GA01045 1
0171045 06/12/2001 GA 1.4 1 .4 M 05/24/2001 5/23/01 1am woke up with a fever - temp not taken tylenol given with good response. Today no fever but "bumps" have broken out on feet & Legs and hands - no other symptoms - advised to watch & if rash gets worse see doctor. U 05/22/2001 05/23/2001 1 PUB PUB GA01050 1
0171046 06/12/2001 GA 0.39 0 .4 F 05/10/2001 Infant broke out in hives after receiving vaccines DTAP, IPV, HIB, Prevnar. No respiratory distress noted. Child alert and smiling. Child had no reaction after same vaccine were given at age 2 months. Infant was taken to Dr's office where oral Benadryl was administered. Y Y 05/08/2001 05/08/2001 0 PVT PUB None None GA01046 1
0171047 06/12/2001 TN 0.8 0 .7 M 05/29/2001 Approximately 2 days post vax, the pt experienced an ear infection and pneumonia. The pt was treated with antibiotics and Augmentin in breathing treatment but was not hospitalized. The pt continues on breathing treatments. She also said her niece had similar bout with pneumonia after being administered Prevnar. Y 03/27/2001 03/29/2001 2 PUB PUB NONE reflux TN01021 1
0171048 06/12/2001 CA 0.5 0 .6 F 05/31/2001 Grandmother states infant was being held, started shaking like seizure, stopped breathing, resumed breathing on own after tactile stimulation by grandmother. Was taken to emergency room at Kaweah Delta District Hosp. Y Y 05/30/2001 05/31/2001 1 OTH OTH None 1
0171049 06/12/2001 MN 1.0 0 1 F 04/24/2001 Noticed pimple rash on L arm at injection site. Small cluster few red pimple areas on face and stomach and back couple on legs. Y 04/12/2001 04/22/2001 10 PVT UNK NO NO 1
0171050 06/12/2001 WA 1.5 1 .5 F 06/07/2001 Approx 6 hrs post Prevnar injection unable to bear wt L leg, limp, refused to bend leg no redness or swelling. Fever to 102F, hiccups; violent x 3 - 6/8/01 continue fever child to be seen is wt bearing. Y 06/05/2001 06/05/2001 0 PVT PUB Healthy baby 1
0171051 06/12/2001 IN 4.0 4 M 06/01/2001 Received vaccine on 5/29/01. On 6/1/01, developed urticarial reaction around injection site, 1cm diameter around injection site clear eryth raised area on rectangular pattern 4cm x 3cm on lateral aspect 3cm x 3cm medial. Y 05/29/2001 06/01/2001 3 PVT PUB 1
0171052 06/12/2001 SC 1.25 1 .2 M 05/23/2001 5/16/01 woke up with low grade fever. Ran fever every day and on 5/19/01 temp went up to 103.7. Mom called ER & ER nurse suggested she report this fever to vaccine administrator since she was the fourth person to report high fever after Prevnar vaccine. Child recovered by 5/20/01, no fever. Y 05/15/2001 05/16/2001 1 None PUB PVT None SC0132 1
0171053 06/12/2001 MI 0.2 0 .2 M Temp 105F, next day @ 2:00 started fever. Y Y 01/23/2001 01/25/2001 2 PUB PUB None None MI2001043 1
0171054 06/12/2001 MI 1.0 1 .1 F 05/09/2001 Post vaccines pt wouldn't walk for 3 weeks with fever. Cried, wouldn't eat. Lost weight. Y 01/31/2001 01/31/2001 0 PUB PUB No None MI2001004 1
0171055 06/12/2001 MI 0.75 0 .8 F 5/03/01 mother states "it seems like she had a fever, I didn't take it with a thermometer though and she's teething. "had diaper rash x 5 days. 5/4/01 runny nose and rash; diaper rash now with red, white headed blisters on diaper area, 3-4 red strawberry looking marks on chest and stomach between dime and quarter in size. many diffuse uncolored bumps all over body. No red rash on thighs. Y U 05/02/2001 05/04/2001 2 No lab test done. Nystatin cream prescribed for diaper area 5/7/01 Mom states she's feeling much better, the doctor's don't think the rash is from her vaccines. PUB PUB Aveeno diaper cream diaper rash None MI2001045 1
0171056 06/12/2001 MS 0.5 0 .6 F 03/28/2001 Redness and hardness approx size of nickel to site where Prevnar administered. Y 03/27/2001 03/28/2001 1 PUB PUB Augmentin Sinus congestion frequent URI's MS01020 1
0171057 06/12/2001 FL 1.08 1 .1 F 06/01/2001 Hives on LUE, RLE Y 05/30/2001 06/01/2001 2 None OTH PUB None None 1
0171058 06/12/2001 SC 0.75 0 .8 M 05/30/2001 After giving injection of Prevnar. Immun baby had an apnea episode lasting approximately 5 seconds. Color pale in appearance. Baby was stimulated after stimulation baby was alert and responding well. Reaction was immediately most likely secondary to pain of injection. Y 05/30/2001 05/30/2001 0 OTH PUB None None None 1
0171059 06/12/2001 CO 0.3 0 .3 M Pt received immunizations on 5/29/01, parent reported verbally to office that patient has marble sized lump at L inner thigh with dime-size erythema - site of Prevnar vaccine. Reported on 5/30/01 U 05/29/2001 05/30/2001 1 PVT PVT None None 1
0171060 06/12/2001 NY 0.3 0 .3 F 05/21/2001 6/5/01 child had a left localized seizure that progressed and ? ? ? went to WMC ??? White Plains Hosp. Seizure lasted greater then 30 minutes as per neurologist - neurologically normal. Y Y 05/03/2001 CSF, ?, EEG. MRI, B/C all WNL PVT PUB No No 1
0171061 06/12/2001 IL 4.0 4 F 06/18/2001 Macular papular rash on face neck, back with superficial edema and erythema site of injection. Occurred 36 hrs post Prevnar vaccine. 05/29/2001 NO PVT PUB None 1
0171062 06/12/2001 NJ 44.0 44 F 06/05/2001 The pt experienced chronic extreme pain in ribs, joint and muscle pain, fatigue, nausea. Treated with Prozac, Darvon. Symptoms still persist. Y N 04/20/1999 08/01/1999 103 No attachment provided. PVT PVT NONE NONE scoliosis 1
0171063 06/12/2001 NJ 44.0 44 F 06/05/2001 The pt experienced chronic extreme pain in ribs, joint and muscle pain, fatigue, nausea, treated with Prozac, Darvon, symptoms still persist. Y N 05/17/1999 08/01/1999 76 PVT PVT NONE NONE scoliosis 1
0171064 06/12/2001 NJ 45.0 45 F 06/15/2001 The pt experienced chronic extreme pain in ribs, joint and muscular pain, fatigue, nausea. Treated with Prozac and Darvon. Pain symptoms still persist. Y N 04/12/2000 lab tests PVT PVT NONE NONE scoliosis 1
0171085 06/12/2001 MI 62.0 62 M 06/06/2001 Pt had mild fever, swelling and warmth at injection site, headache and pain at injection site, all of which lasted approx. 3 days. Y 05/23/2001 06/03/2001 11 PUB PUB NONE NONE NONE 1
0171086 06/12/2001 CA 8.0 4 M 06/04/2001 Varicella vaccine on 12/17/96. Varicella disease on 6/2/01 onset. U 12/17/1996 06/02/2001 1628 PVT PVT PPD/Connaught/2440-11/ID/LFA NONE Pervasive Developmental Disorder 1
0171087 06/12/2001 MA 1.5 1 .5 M 06/05/2001 Erythema and indurated area on left inner thigh 4cm X 6cm; started this AM. Y 05/30/2001 05/31/2001 1 NONE PVT PUB NONE 1
0171088 06/12/2001 MI 58.0 58 F 06/06/2001 Pain at injection site for 2-3 days, 7 days, post vax. Y 05/23/2001 05/30/2001 7 NONE PUB PUB Avista Tylenol III allergy 1
0171089 06/12/2001 WA 1.7 1 .6 M Redness, swelling and increased temperature to right anterior thigh (7cm X 6cm area), slightly tender, afebrile, no limp. Advil (per parent) unsure of dose at time. Y U 05/30/2001 05/31/2001 1 NONE PVT PUB NONE NONE NONE 1
0171090 06/12/2001 MS 5.0 5 F 06/06/2001 Pt came in with mother to have immunizations. Pt had immunizations before without problems. When pt was leaving with mother (approx. 5 minutes, post vax), the pt slumped to floor, curled into fetal position and had a seizure, lasting 1-2 minutes. She recovered. Pupils dilated but weak. Went to ER via car with mother. Y Y 06/06/2001 06/06/2001 0 PUB PUB NONE NONE NONE MS01021 1
0171091 06/12/2001 NE 12.0 12 F 05/15/2001 Post vax of Hep-B, I asked child if she was "ok", as she was quite fearful. She shook her head and replied "yes". She then leaned towards other nurse and had a seizure, lasting < 1 minute. Client was pale, skin cool and moist. HR-62 and even. Within 2-3 minutes, she was aware of person, place and time. Pupils were sluggish and reactive to light. On 5/15/01, mother stated, she has not been ill previously, on no medications and has no previous history of seizures. Physician paged at 17:30. Call returned at 18:00 by physician on call and stated "doubtful vaccine responsible for seizure; possibly caused by fear". Told to send home and have mother call PCP in the AM with an update. Conversation relayed to mother who verbalized understanding. Follow-up call made on 5/15/01 at 09:30 AM to mother. She reported she had been fine, just tired and quieter than normal. Mother had not called doctor yet but intended to call shortly. Recommended remaining Hep-B shots be given at doctor's office. Y 05/14/2001 05/14/2001 0 PUB UNK NONE NONE NE013 1
0171092 06/12/2001 MI 53.0 53 F 06/06/2001 Tetanus injection given 5/19/01. Pt noticed injection site was warm and hard to touch. Wednesday, pt came into clinic to have left deltoid evaluated. Site was warm to touch with a hard knot 3cm X 3cm, and slight redness around site. No signs or symptoms of infection. Y 05/19/2001 05/20/2001 1 PVT PVT NONE 1
0171093 06/12/2001 MA 27.0 27 M 06/06/2001 Case became light-headed, dizzy and unsteady on feet. BP dropped to 76/40. Case was extremely diaphoretic. Diaphoresis and dizziness lasted approx. 10-15 minutes. AP 48 initially. Case given crackers, juice and H2O due to not eating lunch. BP after 20 minutes was 104/76; AP-56. Rechecked after another 10 minutes and BP 118/80 and AP-56. Case then stated fells fine and left office. Case called me about 1 hour later at 14:00 and stated he was fine. Y 06/06/2001 06/06/2001 0 PUB PUB NONE NONE NONE 1
0171094 06/12/2001 OR 0.5 0 .5 M 05/23/2001 Rash starting 4 days, post vax. Started on head and continued down rest of body over the next couple of days. On 5/22/01, rash resolved. No treatment. Low-grade fever X 2 days. Fever responded to treatment with Tylenol. Parent spoke to MD who referred case to health dept. Y Y 05/15/2001 05/19/2001 4 PUB UNK NONE NONE OR200124 1
0171095 06/12/2001 AR 2.0 2 .4 M 04/27/2001 4/26/01, child had quarter-sized knot on left arm where shot was given. Complained of pain, had redness and warmth to touch and unable to sleep on that arm. Today knot a little larger. (Info-per mom of pt). If worsens, is to take to PMD and call and notify HD. On 4/30/01, telephone call to parent: states swelling went down that day and no problems now. Y 04/25/2001 04/26/2001 1 NONE PUB PUB NONE AR0126 1
0171096 06/12/2001 TX 3.0 1 .0 M 06/05/2001 Pt had varivax on 2/4/99. On 6/5/01, pt has herpes zoster (shingles) in right axilla, >15 spots on dermatome. Just dx'd. Expect recovery. U 02/04/1999 06/03/2001 850 PVT PVT NONE NONE Asthma 1
0171097 06/12/2001 TX 1.25 1 .3 M 06/04/2001 The pt experienced a fever of 102 - 103.5. 12 hours post vax, the pt experienced a rash on the face and legs. Parents reported symptoms on 6/4/01. U 06/01/2001 06/02/2001 1 PVT PVT NONE 1
0171098 06/12/2001 CT 48.0 48 M 06/07/2001 Patient developed a 5-6 cm area of local erythema and mild discomfort on right deltoid. Y 05/31/2001 PVT UNK None laceration finger 1
0171099 06/12/2001 MA 1.3 1 .4 F 06/08/2001 Patient developed a local erythematous, indurated reaction. Y 06/06/2001 06/08/2001 2 None PVT PUB None None None 1
0171100 06/12/2001 WA 11.0 11 M 06/05/2001 The pt experienced a varicella like rash. The pt also experienced fatigue for 1 day. the pt evaluated. No known exposure. The pt experienced papular, early vesicular lesions on torso, face, which were mildly itchy. Y 06/01/2001 06/02/2001 1 NONE PVT PUB NONE NONE 1
0171101 06/12/2001 PA 14.0 9 F 06/05/2001 The pt experienced a rash. Y 03/15/1996 05/25/2001 1897 NONE PVT PUB NONE NONE NONE 1
0171102 06/12/2001 NH 9.0 8 F 06/19/2001 The pt's hair started falling out suddenly for no apparent reason. She is losing much more than the normal about every day. Hair loss has been constant for over four weeks. N 04/24/2001 05/16/2001 22 TSH - neg, lead - neg, inflammation - neg PVT PVT NONE NONE NONE blue around lips~Polio Virus, Inact. (no brand name)~1~1.00~In Patient 1
0171103 06/12/2001 CA 1.7 3 M 06/01/2001 The pt experienced 2 blisters on left lower back which progressed to the waist and knee. A dermatologist diagnosed herpes Zoster. Treated with Acyclovir, Denavir, hydroxyzine. Seeing improvement immediately. Y 09/07/2000 05/25/2001 260 PVT PVT NONE NONE NONE 1
0171104 06/12/2001 PA 22.0 22 F 06/07/2001 The pt experienced numbness of lips, tongue felt thick, felt short of breath. Y Y 04/18/2001 04/18/2001 0 PUB UNK UNK NONE Amoxicillin 1
0171105 06/12/2001 AL 1.0 1 .0 F 05/23/2001 Mom states when baby woke up, she had a high fever (by touch) at 08:00. She found the thermometer at 12:00 noon and it was 104.5F (rectally). By 10:00, she had developed diarrhea and vomiting. Took baby to MD at 15:00. Was given Rx antibiotics; gave IV's and drew blood. Took baby to Medical Ctr at 20:00. Temperature 105.5F at 03:00 on 3/23/01. Y Y 03/21/2001 03/22/2001 1 Stool sample-neg; MCE: blood work UNK UNK NONE Allergy to amoxicillin; 8 weeks premature AL0108 1
0171106 06/12/2001 MO 0.3 0 .3 F 05/30/2001 Approx. 1 1/2-2 hours, post vax, infant began to cry, then scream inconsolably and broke into cold, profuse sweat. She was given Tylenol 0.8 ml. Temperature not assessed at that point. Was taken to ER at 20:50 and temperature 97.9; R-40; P-160; wt-17lbs. Dx'd candida dermatitis and viral URI. Y Y 05/29/2001 05/29/2001 0 CBC-abn values; WBC-14.3; HCT-33.7; Platelets 508; Lymph 5% 41.20; Mixed- 15.2%; Wentz 48.6%; Lymphs II-5.9; Mixed #-2.2; Seg Neut-42; Lymph-52 PUB PUB NONE Yeast-Diaper Rash NONE MO2001031 1
0171107 06/12/2001 IA 5.0 5 F 06/08/2001 On 6/7/01, "red dots" and itching right shoulder. On 6/8/01, 1 large red area, approx. size of 1/2 dollar with white dot in the middle. (Description provided by mother) No fever and is playing normally. Rash at MMR or varicella site, possibly mild infection due to scratching of area. Advised to call daughter's physician to see if they want to see her. We will report as a vaccine reaction. On 6/11/01, telephone call from parent, states use of Caladryl topically made itching and swollen area disappear by evening of 6/8/01. Y 06/02/2001 06/07/2001 5 PUB PUB NONE NONE IA01007 1
0171108 06/12/2001 KY 44.0 44 M 06/06/2001 Pt reports he became extremely weak/fatigued evening of vaccine being administered, lasted 12-18 hours. No treatment needed. Y 04/11/2001 04/11/2001 0 PUB PVT NONE NONE NONE KY2001041 1
0171109 06/12/2001 KY 40.0 40 F 06/06/2001 Light-headedness; onset 30 minutes, post vax. Hives, onset 1-2 hours, post vax. Both lasted 24 hours. Y 11/01/2000 11/01/2000 0 NONE PUB PVT NONE NONE NONE KY2001040 1
0171110 06/12/2001 MA 59.0 59 F 06/05/2001 Pt received TD in left arm by IM on 5/29/01. On 6/5/01, a "rash developed". Area is lateral aspect of left arm, 16cm X 8cm, at it's largest point, blotchy erythema, warm to touch and 3cm below site of injection. Husband is a retired dermatologist. Treated at this time with cortisone cream. N 05/29/2001 06/05/2001 7 NONE PUB PUB NONE NONE Seasonal/environmental allergies. 1
0171111 06/12/2001 U Based upon report received from medical professionals, a pt was inadvertently given TD but was supposed to be given a PPD instead. The pt experienced symptoms at the injection site which included, swelling the size of a grapefruit, a dime sized blister, itching and warmth to the touch. U 05/07/2001 05/09/2001 2 UNK UNK 1
0171112 06/12/2001 OH M Site of injection, 10cm X 10cm, indurated, erythematous, warm and itchy area. Y U PVT UNK 1
0171113 06/12/2001 GA 4.0 4 F 05/03/2001 On 5/1/01, noticed fever of 103F (orally). Motrin given. On 5/2/01, AM, mother noticed injection site was red with clear blisters, hard to touch and edematous. Fever of 99.3F in AM. Was sent to school. After school, fever was 101F. Child was irritable, meds given. MD called. On 5/3/01, went to MD or saw CNP. Dx'd as a reaction. Medication for allergic reaction prescribed. Fever in AM was 99.7F. No irritability. Y Y 04/30/2001 05/01/2001 1 PUB PUB NONE NONE GA01039 1
0171114 06/12/2001 GA 3.0 3 F 04/12/2001 On 4/12/01, around noon today, observed right more than left upper arms and when dressing, mother noticed a pink, raised area on back. No treatment by mother. Brought to HD and saw RNC who said it was a topical immunization reaction. Mother said she had Caladryl at home to apply. Call Pediatrician if changes or any worse. Y 04/11/2001 04/12/2001 1 NONE PUB PUB Diuril; bacitracin GA01040 1
0171115 06/12/2001 GA 3.4 3 M 04/12/2001 The pt experienced upper arm redness and warmth to the touch at the site of injection. No discoloration or irritability. Brought to health department. Y 04/11/2001 04/12/2001 1 NONE PUB PUB NONE NONE GA01041 1
0171116 06/12/2001 GA 3.0 3 F 05/02/2001 The mom states the pt experienced a knot like area on the left deltoid at the injection site. No other symptoms. No fever. Treated with Tylenol and cool compresses. Y 05/02/2001 05/02/2001 0 PUB PUB NONE NONE GA01042 1
0171117 06/12/2001 GA 4.0 4 M 05/03/2001 The pt experienced a prickly rash on face, ears, trunk, legs and arms. Onset approximately 10 hours post vax. The pt also experienced a fever. Saw MD on 4/25/01 to rule out strep. Strep was negative. Y Y 04/20/2001 04/21/2001 1 strep - neg PUB PUB NOEN congenital hearing loss GA01043 1
0171118 06/12/2001 GA 4.0 4 M 05/03/2001 The pt experienced a red arm that was red, swollen, and warm to the touch. Y 05/01/2001 05/02/2001 1 PUB PUB NONE NONE NONE GA01044 1
0171119 06/12/2001 GA 11.0 11 M 05/04/2001 The pt complained of itching and fine rash on the face, neck and then the chest, back and arms beginning in the AM. Y 05/02/2001 05/04/2001 2 NONE PUB PUB NONE NONE allergy to iodine GA01044 1
0171120 06/12/2001 GA 1.25 1 .3 M 05/14/2001 The child woke from nap with swollen right arm, which was hot, painful to the touch. The child also experienced difficulty in standing in walking and the next day his right foot was drawing backwards. The pt was taken to PMD and was advised not to have any more DTAP's Child is doing somewhat better. Y U 05/10/2001 05/10/2001 0 NONE PUB PUB NONE NONE NONE Rash~Polio Virus, Inact. (no brand name)~2~0.00~In Patient GA01047 1
0171121 06/12/2001 GA 4.0 4 F 05/15/2001 The pt experienced a fever about 1 hour post vax. Temp was 102 with complaints that he left arm hurt. The fever responded to Tylenol. Temp this morning was 101. Advised to continue with Tylenol and apply cold compresses to left arm. U 05/14/2001 05/14/2001 0 NONE PUB PUB NONE NONE NONE GA01048 1
0171122 06/12/2001 GA 12.0 12 F 05/17/2001 The pt experienced soreness which began on 5/16/2001. A red area with warmth to the touch. U 05/15/2001 05/16/2001 1 PUB PUB GA01049 1
0171123 06/12/2001 TN 1.4 1 .4 F 06/05/2001 The pt experienced a fever of 106 with a seizure 2 times, and respiratory distress. Y Y 03/27/2001 03/27/2001 0 WBC - 13.1, MCV - 79.5, platelets - 582 PUB OTH NONE cold and flu symptoms NONE TN01022 1
0171202 06/12/2001 TN 8.0 F 05/15/2001 Information has been received from a physician concerning an 8 year old female child who in approx. 1998 was vaccinated with 1 dose of varicella virus vaccine live. In approx. 3/00, the pt experienced a severe case of chickenpox, it was noted to be a "pretty bad case" and that she had "chickenpox on her chickenpox". The pt was not known to be immunocompromised. The physician considered hospitalization. Additional information has been required. Y U 03/01/2000 OTH OTH UNK UNK WAES00041010 1
0171125 06/13/2001 UT 56.0 56 M 07/13/2001 Post vax, on 4/1/01 at 06:00, had severe frontal headache and was started on Zithromax. On 4/2/01, had onset of severe bilateral tinnitus. On 4/3/01, saw an ENT doctor. No ear infection but dx'd with cholear nerve infection. Steroids and Augmentin were prescribed for possible sinusitis. On 4/8/01, steroids stopped. On 4/11/01, had onset of extreme lethargy, unable to work. On 4/14/01, had onset of acute CNS changes (confused, disoriented, slurred and thick speech, balance problems, intractable hiccups, headaches, lethargy continues). From 4/14/01 to 4/16/01, had extreme somnolence, difficult to awaken and irritable. On 4/16/01, saw a neurologist, and was dx'd with acute encephalopathy and hospitalized. On 4/18/01, discharged with CNS changes improved. On 4/23/01, balance, disorientation and hiccup problems resolved but still unable to work. San ENT/Tinnitus specialist who felt tinnitus was secondary to an acute bilateral hearing loss, probably would not go away. Prescribed another steroid course and Elavil. On 5/3/01 through 5/12/01, confined to bed secondary to fatigue and lethargy. From 5/12/01 to 5/24/01, fatigue starting to resolve. Current problems: severe, unremitting, bilateral tinnitus; insomnia secondary to tinnitus and fatigue continue to be problems, other CNS problems seem to have returned to baseline. Still unable to work. Y Y Y 3 Y N 03/31/2001 04/01/2001 1 MRI; MRA; LP; ECG-all these results were normal. Liver ultrasound secondary to LFT's. OTH PVT NONE NONE Asthma 1
0171126 06/13/2001 OH 15.0 15 F 05/23/2001 This patient had right arm numbness, left frontal headache, aphasia, mental status altered changes, nausea and vomiting. Sickness occurred over 1 - 2 hour period and progressed to confusion and aphasia with in 6 hours; better in 12 - 15 hours. Y Y 2 Y 05/21/2001 05/22/2001 1 CT Scan of the head with and without contrast - Wnl. CBC, BMP, Liver - Wnl. PVT UNK NONE NONE NONE 1
0171127 06/13/2001 0.08 0 .1 M 06/07/2001 "A mother reported that her son received his 1st doses of DTAP, HIB and IPV and his 2nd dose of HEP-B vaccines in early July, 1998. He reportedly, developed injection site reactions characterized by hard lumps, redness and warmth. He later, experienced a "high" fever. His mother notified the physician. The pt became irritable and inconsolable. He experienced high-pitched screaming for several hours and arching of his back. He became chronically constipated, needing help to pass hard, clay-like lumps, which often made him bleed. Shortly following his immunizations, he experienced a series of "vague seizure activity". His entire body would twitch and he would seem unresponsive. The physician was notified. He experienced a few more episodes and recovered. Convulsions are considered "Medically Important"." Y 07/01/1998 UNK OTH OTH UNK UNK Weight loss and anorexia~Hep B (no brand name)~1~0.00~In Patient U2001007780 1
0171131 06/13/2001 NY 3.0 3 M 06/06/2001 Shortly after pt received Prevnar, pt had febrile seizure, in the car on the way home, and was brought to local ER with a temperature of 103F. Pt also had 2nd and 3rd febrile seizures on 4/18/01 and 4/19/01. No history of seizure disorder prior to Prevnar. Y Y 1 Y 03/23/2001 03/23/2001 0 In the office, pt had negative Rapid Strep-neg; throat culture-neg PUB UNK History of sore throat, fever. No fever in the office. NONE 1
0171135 06/13/2001 NY 17.0 17 F 06/12/2001 On 4/19/01 and 5/16/01, the pt received her 1st and 2nd doses of Engerix-B, respectively. On 6/1/01, the pt was seen in the physician's office with nausea, vomiting and fever. She was noted to have an enlarged liver; no jaundice was noted. It is unknown if viral hepatitis serologies were obtained. She was treated with prochlorperazine (Compazine). She subsequently, had a dystonic reaction which resolved (see report 2001013944-2). The nausea, vomiting and fever resolved on an unspecified date. The pt was seen by the physician on 6/6/01 and was found to be jaundiced. However, the vaccinee "looks and feels better". Repeat of 6/6/01, liver enzymes and hepatitis panel were performed; results were pending as of 6/6/01. This report is considered "Medically Serious". As of 6/6/01, the jaundice was ongoing. The outcome of the enlarged liver and elevated liver enzymes was not specified. F/U on 9/14/01, it was reported that the pt was referred to a gastroenterologist. A dx of hepatitis A was made and the pt rec'd unspecified outpatient tx. The reporter stated tat the hepatitis A infection was unrelated to Engerix-B. As of 9/14/01 the outcome of the hepatits A was unknown. Hepatitis A is considered medically serious. Per F/U, On 5/31/01, she developed arthralgias, myalgias and a fever of 103F. The gastroenterologist saw the pt on 6/8/01 and at that time, the pt reported "extreme" fatigue, decreased appetite, diffuse abdominal pain and nausea. She had juandice of skin and mild scleral icterus. Dx was a "Hepatitis of an unknown etiology" and prescribed rest. She was seen by this doctor again on 6/11/01 and was feeling better and was able to eat without nausea or vomiting but remained weak. She was much more jaundiced and had increasing scleral icterus. This same doctor saw the pt again 7/5/01 and she had gained 6lbs. The most recent information received on 10/15/01, the vaccine provider stated "The pt already had hepatitis prior to the shot (of Engerix-B)". She also stated that the Hep-A infection was "not at all related to Engerix-B". Outcome of the Hep-A infection was not specified. Y U 05/16/2001 05/31/2001 15 Unspecified test for mononucleosis was neg; CBC-revealed a 'left shift'; AST-155 IU/L; ALT-137 IT/L. Repeat of 6/6/01 liver enzymes and hepatitis panel were performed; results were pending as of 6/6/01. 6/6/01 AST-6050IU/L;ALT-6080IU/L; BILTOT-7.4mg/dl; BILDIR-2.98mg/dl; 6/8/01 AMYLAS-110U/L; LIPASE-214U/L; PT-14.8SEC; INR-1.5; PTT-24.1SEC; 6/20/01 AST-72IU/L; ALT-295IU/L; BILTOT-4.1mg/dl; 6/8/01 EBV titer-neg; CMV titer-neg; Hep-A titer-(+) PVT PVT Compazine started on 6/1/01; metoprolol (Toprol XL) 25mg daily allergy to PCN; anemia; sinus tachycardia 20010139441 1
0171136 06/13/2001 VA 1.0 1 .0 M 06/11/2001 This report was received on 5/16/01 from the mother of a 12 month old male who was vaccinated with Prevnar (dose 3), Varivax (MSD) and MMR on 1/10/01. Two days later, on 1/12/01, the infant experienced a seizure described by his mother as, "his eyes shut, his head jerks to the right and his right shoulder pulls up". No fever was associated with the seizure. The mother reports he has had at least 75 seizures, which last less than 5 seconds, since 1/12/01. The infant was referred to a pediatric neurologist and "benign seizure disorder" was dx'd. The mother states the neurologist could not determine a cause and she was told he would "probably out grow" the seizures. No medications were prescribed and the infant was to return if the seizures continued for 6 months. The mother reported the seizures were subsiding. Follow-up information was received from the pt's pediatrician on 6/8/01. The physician indicated that the pt had "possible seizures", but referred to them as "spells" rather than "seizures". He noted that a dx of "stereotypic spells" was made, rather than "benign seizure disorder" that was originally reported by the pt's mother. Also, the pt was reevaluated by neurologists. He also noted that "it is clear that the spells began soon after the vaccine". NOTE: The follow-up information received on 6/8/01 has upgraded this report to a "15-day", serious/unexpected report. F/U states that information was received from a consumer concerning her 12 month old son with a history of a viral illness of an upper respiratory infection with a loose cough (1/2/01) who on 1/10/01 was vaccinated with a 1st dose of varicella (lot 636569/0926K), a 3rd dose IM in the thigh of Prevnar and a 1st dose of MMRII (lot 637255/1380K). There were no other concomitant medications, illnesses or fever at the time of vaccination. On 7/12/01, the pt experienced a seizure described by the mother as "his eyes shut, his head jerks to the right and his right shoulder pulls up". There was no fever associated with the seizure. It was reported at the time of the report by the child's mother that the child has had "at least 75 seizures" since 1/12/01, each of which lasted less than 5 seconds. On 1/23/01, the mother reported to the pediatrician that the child "had stopped sleeping, was not napping and had a twitch of his right arm that had been occurring for the past week and a half". The pt was referred to a pediatric neurologist on 1/30/01 and a rule out seizure disorder. The pt was seen by a pediatric neurologist on 1/30/01 and a dx of "benign seizure disorder" was made. It was noted that the neurologist could not find a cause and that the child would "probably outgrow" the seizures. The pt was not prescribed medications and is to return to the doctor if the seizures contined for 6 months. On 2/4/01, the pt's mother reported that the seizures were occurring less frequently. On 7/5/01, it was noted that no seizures had been noted in the past month. The reporter felt that benign seizure disorder was not related to the therapy with varicella, Prevnar or MMRII. Upon internal review, the pt's benign seizure disorder was considered to be an "Other Important Medical Event". F/U has been received from a physician and indicated that on 7/5/01, at the pt's last check-up, there had been no spells of seizures since 5/01. As of 8/30/01, it was unknown if the pt recovered from his experience. Additional information has been requested. Y U 01/10/2001 01/12/2001 2 ON 1/30/01; EEG and MRI of brain-normal; temperature measurement on 1/10/01 and 1/12/01 were nml PVT OTH NONE NONE Upper respiratory infection; cough HQ0988117MAY2001 1
0171138 06/13/2001 NY 78.0 76 F 05/30/2001 3-4 days, post vax, every joint in body aches. Had eye surgery for glaucoma at the end of 4/99. Knees, elbows and wrists are worse in the mornings. On 5/3/99, recommended to take anti-inflammatory X 5 days, then call if not improved. Pt cannot sleep or drive. Back of calves and back of knees are severely painful. The pain is worse when lies down. Does not hurt when she walks. On 5/28/99, dx'd with polymyalgia rheumatica. She also has OA of hands and both knees (R>L). I am a little bothered by the ptosis on the left which apparently began a few months ago. I will start her on 15mg prednisone a day and ask her to taper the Motrin as needed. Y 04/14/1999 04/18/1999 4 Blood studies done and doctor thinks she most likely has polymyalgia rheumatica. Most recent ESR was even higher at 75mm/hr (role of Lyme immunization is unclear to me). PUB OTH NONE NONE 1
0171139 06/13/2001 MN 0.3 0 .3 M 06/05/2001 Patient began crying 4 am on the morning after immunization. By 8 am, he was screaming nonstop. Tylenol did not help. Patient was taken to the clinic and told it was a reaction to vaccine and to continue taking Tylenol. Patient continued crying all day for two days. On the third day he was fussy, and by the next day, he was all right. He had a low grade fever of 100.6. He had a red, swollen leg at site of DTAP injection. Y 05/21/2001 05/22/2001 1 PVT OTH None None 1
0171140 06/13/2001 IL 1.0 0 .8 M 06/05/2001 Patient developed redness and swelling of leg. Y Y 03/21/2001 03/22/2001 1 PVT PUB None None None 1
0171141 06/13/2001 MI 2.0 2 .2 M Patient developed a pink, fine rash on trunk and arms that was like a sunburn. Patient noted to have an allergic reaction. Y 05/17/2001 05/17/2001 0 PVT PVT 1
0171142 06/13/2001 FL 1.0 1 .0 M 06/06/2001 Patient noted to have a hive at injection site where MMR given. He was immediately given Benadryl and stayed for 1 hour. The hive disappeared. Y 06/05/2001 06/05/2001 0 None PVT PUB Pharyngitis 1
0171143 06/13/2001 GA 0.8 0 .8 M 06/06/2001 Patient developed a temperature of 103 that lasted 24 hours. He recovered without sequelae. Y 05/29/2001 05/30/2001 1 None PVT OTH Albuterol nebulizer, Pulmicort nebulizer None Reactive airway disease 1
0171144 06/13/2001 TN 0.3 0 .4 F 04/16/2001 Approximately 30 minutes after vaccines given, mother reported that patient had an episode of jerking. Mother called on 4/16/01 to report that patient had no more episodes, but she had taken her to the ER, and the ER doctor started patient on anti-seizure medication. Patient was to be seen by a neurologist. Y U 04/09/2001 04/09/2001 0 PUB PUB None None None TN01018 1
0171145 06/13/2001 TX 4.0 4 F 06/01/2001 Within 24 hours, patient developed redness, swelling and warmth to the right thigh where injection was given. Erythema spread. Patient was seen in the clinic 2 days after DTAP vaccine. Site size was 8.5cm x 8.5cm. She was treated for cellulitis with Rocephin and Augmentin. It is not clear if she had an allergic reaction or cellulitis secondary to injection puncture site. It was resolved or very much improved on follow up office visit 6/1/01. Y Y 05/29/2001 05/30/2001 1 PVT PUB None None 1
0171146 06/13/2001 NE 1.25 1 .3 M 06/05/2001 Patient developed swelling and redness on front and sides of left thigh extending to knee. The area was warm to the touch. Patient noted to have a slight limp with walking. U 06/04/2001 06/05/2001 1 None PVT PVT None None None 1
0171147 06/13/2001 CA 12.0 12 M 05/22/2001 Patient became dizzy, pale and nauseated after shots. He vomited several times. His vital signs were stable and his color returned to normal. He left after 15 minutes. Y 05/22/2001 05/22/2001 0 OTH OTH PPD applied to left forearm 1
0171148 06/13/2001 CA 87.0 86 F 05/10/2001 Patient developed ache in arm immediately after injection. The next day she was weak and sweaty and her arm was painful. She could hardly move it. On 4/8/01, she went to hospital ER and was diagnosed with shingles under left arm and on chest. Y N 11/20/2000 11/20/2000 0 12/28/00: ESR 1/9/01: x-ray right shoulder and humerus: arthritis PVT PVT Aspirin, atenolol, Norvasc, Cozaar, Lipitor None Heart disease 1
0171149 06/13/2001 CA 11.0 11 F 06/05/2001 Patient developed a 5cm x 5cm annular, erythematous, indurated lesion at injection site. Y 05/29/2001 05/30/2001 1 PVT PVT None None None 1
0171150 06/13/2001 NY 5.0 5 F 06/06/2001 Patient developed nausea, diaphoresis, pallor, hives and itching. She was given Benadryl. Y 06/05/2001 06/05/2001 0 PVT PVT None Soy, dextrocardia, situs inversus 1
0171151 06/13/2001 FL 4.0 4 F 06/04/2001 Patient developed 3 inches of marked erythema and induration with slight bruising in left deltoid where DTAP was given. Y Y 05/03/2001 05/05/2001 2 PVT PVT Parkdale PPD, lot #00980P, right forearm, Ditropan, Benadryl, amox, Sudafed, multivitamin pharyngitis Cefzil, bladder incontinence 1
0171152 06/13/2001 CA 5.0 5 M 06/04/2001 Patient developed a 5cm erythematous and tender annular wheal. Y 05/22/2001 05/23/2001 1 PVT PVT Aventis PPD, lot #C0824AA, placed on right forearm None Peanut allergy 1
0171153 06/13/2001 CA 5.0 5 F 06/05/2001 Patient developed a 4cm x 4cm erythematous, indurated lesion at injection site. Y 05/16/2001 05/17/2001 1 None PVT PVT Aventis PPD, lot #C0824AA, placed in right forearm None None 1
0171154 06/13/2001 MI 18.0 18 F 05/05/2001 Patient developed muscle aches in arms, shoulders and left leg. Hands were sore to write with. On 6/5/01, patient got a fungus in the mouth and became very tired. She developed a strange illness at school and then slept 2 days. After 5 weeks, she was still very tired and receiving treatment for oral fungus. Y 04/16/2001 04/20/2001 4 PVT PVT None None geographic tongue 1
0171155 06/13/2001 NY 49.0 49 M 06/04/2001 Approximately 24 hours post injection, patient noted tenderness and hyperemic warmth at site. Local treatment was recommended along with Motrin or Advil. Y 06/02/2001 06/03/2001 1 MIL MIL None Shrimp 1
0171156 06/13/2001 NY 4.5 4 F 05/12/2001 Patient developed a fever that lasted about 4 days. She then developed a cough that lasted for over a month. The cough came and went for the next 2 months. Patient was then noted to cough whenever she ate peanuts. She developed a peanut allergy. Y N 02/05/2001 02/05/2001 0 Blood test to test for peanut allergy PVT OTH Albuterol Allergy to cats, asthma 1
0171158 06/13/2001 VA 51.0 51 F 06/01/2001 Patient developed diarrhea, nausea and vomiting 3 days post vaccines. Y 05/16/2001 05/19/2001 3 MIL MIL None None 1
0171159 06/13/2001 VA 18.0 18 F 06/04/2001 Five minutes after patient received vaccine, she felt faint and vomited. Pupils were dilated, and she was cold and clammy. Y 06/04/2001 06/04/2001 0 None PUB OTH Parkdale PPD, lot #01231P Anemia Allergy to peanuts and shellfish 1
0171160 06/13/2001 CA 0.2 0 .2 F 06/12/2001 Patient developed hives over entire body. Y Y 06/11/2001 06/11/2001 0 None OTH PUB None None None 1
0171161 06/13/2001 PA 29.0 29 F 05/22/2001 Approximately 17 hours post immunization, the patient developed a large, hardened area where vaccine was administered. About 8 hours later, she felt nauseous. About 10 hours later, she developed a stiff neck, headache and temperature of 101 with chills. Her left arm developed spasms running down her arm which have lasted until the present. On 5/22 she developed a rash at and around the injection site which was warm to the touch. Y 05/18/2001 05/19/2001 1 PUB PUB Allegra Nasal congestion Seasonal allergies 1
0171162 06/13/2001 MS 0.6 0 .6 M 05/14/2001 Patient noted to be asleep and then began groaning and eyes were half open. He could not be aroused with stimulation. The episode lasted 45 seconds to 1 minute. Then the patient's eyes opened wide and he came around. Patient was seen by neurology. Y 05/07/2001 05/07/2001 0 PVT PUB resolving otitis media paroxysmal episodes limp, difficult to arouse, hypotonic~DTaP (Tripedia)~0~0.20~In Patient MS01019 1
0171163 06/13/2001 FL 1.9 1 .4 M 06/12/2001 Patient received Varivax 11/28/00. On 6/11 patient noted to have a rash all over. Patient was diagnosed with chickenpox during office visit on 6/11/01. Y N 11/28/2000 06/11/2001 195 PVT PVT None 1
0171164 06/13/2001 NY 49.0 49 F 05/07/2001 Three days post vaccine, patient developed a fever. One week post vaccine, the patient had pain and difficulty moving her joints all over. Daily tasks, such as climbing stairs and getting out of bed, were difficult to perform. U 03/09/2001 03/12/2001 3 PUB UNK None None None 1
0171165 06/13/2001 FL 6.0 F 05/16/2001 Patient broke out in chickenpox after receiving the varicella vaccine several years prior. U PVT PVT 1
0171166 06/13/2001 AL 4.0 4 F 05/23/2001 Patient developed a 10cm x 12cm area of erythema and induration at injection site. Y Y 05/21/2001 05/22/2001 1 PVT PVT None None None 1
0171167 06/13/2001 CA 12.0 11 F 05/22/2001 Patient developed a raised rash all over the body approximately 1.5 days after being vaccinated. Mother treated with Benadryl and a topical cream. The rash would disappear and reappear about every 4 hours when the Benadryl wore off. The rash lasted for about 5 days. Y 10/25/2000 10/27/2000 2 None PUB OTH None None None 1
0171168 06/13/2001 MA 6.0 6 F 05/24/2001 Patient developed a fever of 102.5 and lethargy. She slept most of the day on 5/12, 5/13 and part of the day on 5/14. Y 05/11/2001 05/12/2001 1 None PVT UNK Rabies immune globulin given 5/5/01, Flagyl, Culturelle, iron None Hirschsprung's disease 1
0171169 06/13/2001 MA 6.0 6 F 05/24/2001 Patient developed lethargy and a temperature of 101 for 1 day. She slept all afternoon on 5/19. Y 05/18/2001 05/19/2001 1 None PVT UNK Rabies immune globulin 5/5/01, Flagyl, Culturelle, iron None Hirschsprung's Disease 1
0171170 06/13/2001 IL 7.0 7 M Patient developed a rash on left arm and neck within 24 hours after receiving vaccine. The rash resolved itself within a few days. Y 03/13/2001 03/13/2001 0 None PUB PUB None None 1
0171171 06/13/2001 KY 15.0 15 F 05/25/2001 Patient became febrile and vomited several times. Fever responded to Tylenol but returned. The fever lasted 24 hours, and the vomiting lasted 12 hours. Y 05/22/2001 05/22/2001 0 OTH PUB None None None 1
0171172 06/13/2001 KY 14.0 14 F 05/25/2001 Patient was noted to be febrile and nauseated the day following injection. She was given Tylenol which decreased her temperature. Y 05/22/2001 05/23/2001 1 OTH PUB None None 1
0171173 06/13/2001 PA 1.5 1 .3 M 06/06/2001 The pt developed the measles. U 05/25/2001 06/05/2001 11 PVT PUB NONE NONE 1
0171370 06/14/2001 NH 0.08 0 .1 F 06/04/2001 The baby died from SIDS. Y 03/04/2001 N 02/26/2001 03/04/2001 6 PVT PUB NONE NONE NONE NH0117 1
0171378 06/14/2001 MT 40.0 39 F 05/01/2001 The pt was dx'd with thrombocytopenia purpura on 8/2/00. She required multiple plasmapheresis exchanges and splenectomy (occurred on 12/20/00). Follow up on 06/19/2001: "Patient has recovered from adverse event. Patient is back on full duty, and workdays missed was 35-40 days. Patient has been evaluated by a physician or health care provider for this event. " Y Y Y 25 Y 03/14/2000 07/31/2000 139 Thrombocytopenia and anemia. MIL MIL Iron NONE Iron deficiency anemia; allergic rhinitis 1
0171380 06/14/2001 CA 45.0 45 F 06/07/2001 On 8/10/00, pt was given Tetanus booster for puncture wound on left foot with localized tetany. DOI 8/1/00 and on 8/5/00, pt began having fasciculations and cramping in the left foot. On 8/15/00, pt was having multiple generalized symptoms with neck stiffness, dysphagia, multiple muscle spasms, anxiety, photophobia, phonophobia which were progressing and is currently still having multiple symptoms. It is uncertain if symptom progression after the booster on 8/10/00 are related, but pt did have previous reaction or symptoms after Tetanus booster. Case was reported to health dept as Tetanus. The annual follow up received on 6/27/02 states improved but remains with muscle twitching and intermittent paresthesias and peripheral neuropathy sx pt is approximately 80% resolved. Y N 08/10/2000 08/15/2000 5 9/8/00; CBC; ESR; Chem-20-All WNL 11/15/00-Tetanus Ab Titer 2.0 PVT UNK TIG given in ER on 8/15/00 for suspected generalized Tetanus. Puncture wound of left foot Allergy to PCN; Hayfever; Hx of heart palpitations (asymptomatic) Lock jaw;~DT Adsorbed (no brand name)~~5.00~In Patient 1
0171381 06/14/2001 FL 0.5 0 .5 M 06/13/2001 After the 1st set of vaccines, DTAP, IPV, Hib at 5 months of age, pt developed fever up to 102F, shortness of breath, limp and erythema extending for about 30" from knees. Pt admitted to ICU for observation of fever. No other episodes. Work-up neg except for anemia. After 2nd set of vaccines DTAP, PIV, Hib, another episode of shortness of breath; fever up to 101F; no LOC. Y Y Y 2 Y 06/05/2001 06/05/2001 0 Anemia-H X H 7.5/30.5 PVT PVT NONE RAD; Allergic to amoxicillin; heart murmur 1
0171382 06/14/2001 CO 1.0 1 .0 F 05/25/2001 Immediately after the MMR was given the pt developed a 3x4cm area of pink, blanching rash with central raised urticarial lesions observed for 10 minutes. The area of pink rash decreased. No other rash lesions noted. Instructed to use cool compress, and Benadryl as needed. Return to clinic if symptoms worsen. Y 05/23/2001 05/23/2001 0 NONE OTH UNK hydrocortisone NONE NONE 1
0171383 06/14/2001 OH 0.2 0 .2 F 06/07/2001 Approximately 2 days post vax, the pt became more fussy, and eating decreased. This persisted for at least one week. She was seen in the office on 5/26/01 and 5/31/01. There was not fever. She gained 10 ounces in that time period. Y U 05/23/2001 05/25/2001 2 PVT PVT NONE NONE 1
0171384 06/14/2001 CO 1.0 1 .1 M 05/24/2001 No information provided. Y 05/18/2001 05/18/2001 0 OTH UNK Flucinolone, hydroxyzine, cephelexin eczema NONE ~Measles + Mumps + Rubella (no brand name)~1~1.00~In Sibling 1
0171385 06/14/2001 CO 1.15 1 .1 M 05/24/2001 The pt developed a large hive around where the MMR vaccine was give. The pt's doctor looked at it and ordered Benadryl. The pt stayed for 20 minutes to assure the Benadryl worked and the hive is better. Hive is better and less swollen. Cold compress was applied at short intervals with positive results. Y 05/18/2001 05/18/2001 0 NONE OTH UNK NONE NONE NOEN ~Measles + Mumps + Rubella (no brand name)~1~1.00~Sibling 1
0171386 06/14/2001 MD 1.25 1 .2 F 06/06/2001 The pt's developed cellulitis, swelling, redness and warmth to the left arm. The pt also had a fever of 101 for 24 hours. The right arm had redness, warmth at the injection site. Y 06/04/2001 06/05/2001 1 PVT PVT serous OM recurrent OM 1
0171387 06/14/2001 IA 0.7 0 .6 F 06/04/2001 The pt experienced swelling of the left leg, moves leg, but not freely as right leg. The pt was taken to the MD for exam. The pt also ran a fever. Y Y 05/10/2001 05/16/2001 6 NONE PUB PUB NONE NONE NONE 1
0171388 06/14/2001 CT 0.3 0 .4 M 06/11/2001 The pt slept for 24-36 hours post vax, had a low grade fever, then had normal behavior during the daytime but fitful, wakeful sleep at night. This persisted through the evening of 6/10. Y 06/07/2001 06/07/2001 0 PVT PVT NONE NONE 1
0171389 06/14/2001 NY 1.25 1 .3 F 06/06/2001 About 30 minutes post vax, the pt developed hives over elbows, knees, buttocks. No wheezing was noted. Given Benadryl by mouth and observed at the health center for 2 hours before releasing. Y 06/01/2001 06/01/2001 0 NONE UNK UNK NONE NONE NONE 1
0171390 06/14/2001 MA 4.0 4 M 06/07/2001 The pt experienced a fever beginning 2 hours post vax with swelling of arm which was localized. The swelling resolved but evolved into red blotchiness. The pt also experienced a headache and vomiting. Y N 06/04/2001 06/04/2001 0 PVT PUB NONE 1
0171391 06/14/2001 TX 1.6 1 .6 M 06/09/2001 The pt came in on 6/8/01 with a fever greater than 101. Y U 06/07/2001 06/08/2001 1 CBC, WBC - normal PVT PUB URI 1
0171392 06/14/2001 AR 3.8 3 F 06/11/2001 The pt experienced localized redness and swelling at the injection site, fever. Treated with warm wash cloth and Tylenol. By by 6/10 AM. Y Y 06/07/2001 06/09/2001 2 NONE PVT PUB Miralax Constipation NONE 1
0171393 06/14/2001 26.0 26 M 01/31/2001 The pt felt a burning pain to the front of the arm 25 minutes post vax which lasted 20 minutes. 12 hours later the pt had feet jitters, then 48 hours later a temp of 99 and body aches and headaches. Y 01/29/2001 01/30/2001 1 NONE MIL MIL NONE NONE NONE 1
0171394 06/14/2001 TX 77.0 77 M 06/12/2001 The pt experienced swelling, redness and a temperature. U 06/10/2001 06/11/2001 1 NONE PVT PVT Lipitor, ASA DM DM, DJD, drug allergies 1
0171395 06/14/2001 OH 0.2 0 .0 M 05/31/2001 Following vaccine the pt became ill, was fussy, crying, and fever. The child remained ill for weeks. The administering hospital researched and discovered route should have been by per cutaneous disc. No disc was supplied with the vaccine. U 05/05/1998 05/05/2001 1096 UNK UNK 1
0171396 06/14/2001 MA 76.0 76 F 05/22/2001 The pt experienced wheals in the left deltoid, feels warm to the touch. The area measured 3 1/2 x 4 1/2 inches in size. Y Y 05/10/2001 05/22/2001 12 NONE PUB PVT BP medication, and Lipid medication 1
0171397 06/14/2001 VA 18.0 18 F On 5/29/01 the pt developed a headache following the receipt of the meningococcal vaccine 4 days prior. The pt complained of not being able to hear, or see, was dizzy. She then was sent to the ER. Told was reaction to "shot". Y Y 05/25/2001 05/25/2001 0 PUB PVT NONE NONE had possible seizures with the pertussis vaccine, allergy to Ceclor fever, seizures~Pertussis (no brand name)~~0.25~In Patient VA01015 1
0171398 06/14/2001 FL 5.0 1 .0 M 06/07/2001 The pt was presented with mild varicella. Y Y 08/06/1996 06/07/2001 1766 PVT PVT NONE NONE 1
0171399 06/14/2001 AZ 4.0 4 F 06/07/2001 The pt's left upper arm was red, warm to the touch on 6/5/01, gave Benadryl and was worse the following day. There was a 5 x 8 area of erythema and warmth. No discomfort with movement. Y Y 06/04/2001 06/05/2001 1 PVT PVT NONE NONE NONE 1
0171400 06/14/2001 TN 0.4 0 .4 F 06/06/2001 The pt's left thigh was enlarged, red, raised around the vaccine injection site with a firm nodule. Non-tender. Treated with Benadryl. Y 06/05/2001 06/06/2001 1 PVT PUB NONE NONE NONE 1
0171401 06/14/2001 MI 0.2 0 .2 M 06/08/2001 The pt experienced a red and swollen injection site with a fever and prolonged crying for longer than 6 hours. Y Y 06/07/2001 06/07/2001 0 PVT PVT NONE NONE allergy to milk 1
0171402 06/14/2001 NY 41.0 40 F 11/02/2000 The pt went to the ER for symptoms of light headedness, nausea, vomiting and upper body aches and on 10/13/00 states that she is still experiencing these symptoms. Went to MD and TSH was slightly low and medicine was adjusted. Y Y 09/18/2000 09/26/2000 8 Work up - nml, TSH - low, echocardiogram - neg, CBC, metabolic profile, Hep and liver profile, all nml OTH UNK Synthroid possible viral illness hypothyroidism, hyperlipidemia 1
0171403 06/14/2001 CA 3.0 3 F 06/04/2001 4 days post vax, the pt developed redness at the injection site. Seen in our office with an indurated area and 10cm x 4 1/2 cm erythema warm and tender. Diagnosed with cellulitis. Treated with Augmentin and cool compresses. Y 05/17/2001 05/21/2001 4 NONE PVT PVT NONE NONE NONE 1
0171404 06/14/2001 CA 10.0 5 M 06/05/2001 The pt experienced Varicella vaccine failure. Was vaccinated in 1996 and was seen in the office with approx 30 spots, red based, fluid filled first appearing on 6/3/01. Y U 07/22/1996 06/03/2001 1777 NONE PVT PVT PPD / Connaught NONE NONE 1
0171405 06/14/2001 NC 0.2 0 .2 F 05/21/2001 The night of 5/11/01, the pt began screaming and it continued through 5/12/01. Y 05/11/2001 05/11/2001 0 PVT UNK NONE NONE NONE NC01053 1
0171406 06/14/2001 VA 11.0 11 M 05/15/2001 1 minute post vax the pt slumped over in the chair, eyes closed, non-responsive, right leg and both arms with jerky movement. After 1 minute he opened his eyes and appeared dazed. He reported nausea and headache. Student was very pale and 911 was called. The student was taken by family to MD. MD felt it was an allergic reaction and referred them to an allergist. Y Y 05/15/2001 05/15/2001 0 OTH PUB NONE NONE allergy to peanuts VA01014 1
0171407 06/14/2001 CA 14.0 14 F 06/06/2001 The pt felt dizzy, had blurry vision, right after vax. The pt also felt tired, but was talkative. No SOB. Epinephrine given and symptoms resolved. The pt also sweated. Y 06/06/2001 06/06/2001 0 Hgb - 14.1 PVT PUB NONE NONE NONE 1
0171408 06/14/2001 MA 5.0 5 M 06/06/2001 The pt experienced erythema and swelling on the left deltoid area. No fever. Y 06/04/2001 06/05/2001 1 PVT PUB NONE 1
0171409 06/14/2001 HI 1.5 1 .5 M 06/06/2001 1 day post vax, the pt experienced a red and swollen thigh. No fever, no tenderness. Walks normally. Seen in clinic. 9 x 5 1/2 cm area of erythema and induration. No fever, no tenderness. Recommended cool compresses and Tylenol. Y U 06/05/2001 06/06/2001 1 NONE PVT PUB NONE NONE atopic dermatitis 1
0171410 06/14/2001 FL 5.0 1 .0 M 06/08/2001 The pt was presented to the office with varicella. Y Y 07/15/1996 06/08/2001 1789 PVT PVT NONE ear infection NONE 1
0171411 06/14/2001 IN 0.5 0 .3 F The pt experienced a fever of 103.7 the night of the vax and also redness at the injection site of polio. Y 03/08/2001 03/08/2001 0 NONE PVT PUB Tylenol and Motrin rhinorrhea and congestion 1
0171412 06/14/2001 NV 1.08 0 1 M 06/07/2001 9 days post vax, the pt developed a fever of 104.5 and had a seizure. The next day developed a rash. Seen at the ER. Y Y 03/19/2001 03/28/2001 9 NONE PVT PUB Tylenol NONE NONE 1
0171413 06/14/2001 KY 4.0 4 M 06/11/2001 The pt was taken to the ER with a 1 3/4 inch raised red area at the injection site with some itching. No pain or SOB. The pt was told it was a reaction. No treatment ordered. Y Y 06/05/2001 NONE PUB PUB Ritalin NONE NONE 1
0172233 06/14/2001 TX 3.0 3 M 05/15/2001 On approx. 2/7/01, the pt developed a mild chickenpox rash. The pt sought medical attention. The nurse reported on FOLLOW-UP that the patient developed chicken pox after exposure to a classmate with the illness. Subsequently, the patient recovered. No further information is available. Y U 02/27/1999 02/07/2001 711 OTH OTH NONE UNK WAES01030769 1
0171537 06/15/2001 0.75 0 .7 F 12/11/2001 Information has been received from a health professional concerning a 9 month old female who was vaccinated on approx. 3/26/01 with a dose of haemophilus b conjugate vaccine + Hep-B vaccine recombinant (yeast). On 5/5/01, the pt developed meningitis and bacteremia. Upon internal review the pt's experiences were considered an "Important Medical Event". No further information is available. The follow-up states that the pt was admitted to the hospital. Relevant lab tests indicate that the pt had a positive blood culture. It was noted that on 11/22/2000 and 01/16/2001 the pt was vaccinated with a first dose IM in the right leg and a second dose IM in the left leg of HibTITER. Follow-up info has been received from a health care professional who reports the pt had residual hearing loss on the right side. Upon internal review, residual hearing loss was considered an other important medical event. Additional info has been requested. Y Y Y N 03/27/2001 Blood culture on 5/5/01-positive (bacteria) OTH OTH UNK WAES01060678 1
0171539 06/15/2001 57.0 M 06/06/2001 It was reported that a 57 year old male with stage IV non-Hodgkin's Lymphoma who was vaccinated with pneumococcal vaccine 23 polyvalent at the time of his splenectomy for stage IV non-Hodgkin's. Three years, post vax, the pt developed fevers, chills, hypotension and a generalized seizure. The pt was treated with antibiotics for 4 weeks. He was treated with ceftriaxone, vancomycin and rifampin. Although the pt had been vaccinated against Streptococcus pneumoniae at the time of his splenectomy, he showed a protective antibody response to only 8 of 12 serotypes tested. A Gram's stain of the CSF showed gram-positive organisms in pairs and short chains, but cultures of the CSF were negative. A latex-agglutination test was positive for Streptococcus pneumoniae. During the next several days, disseminated intravascular coagulation and symmetric areas of pallor developed on the back of both hands and the soles of the feet, with overlying bulla. Cultures of the bullous fluid were sterile. The lesions progressed to dry gangrene. All blood cultures remained negative. The arterial supply to each of the arms and legs remained patent. The pt was revaccinated. It was noted that the pt's appearance was typical of symmetric peripheral gangrene associated with Streptococcus pneumoniae bacteremia in a pt whose spleen had been removed. Upon internal review, the pt's experiences were determined to be "Other Medical Events". Additional information has been requested. Y U Diagnostic labs-cultures of the bullous fluid were sterile; latex agglutination-positive for streptococcal pneumonia; blood cultures remained neg; Spinal Tap-neg for gram + organisms; Dx lab-protective antibody response to only 8 of 12 serotypes tested; Gram stain-CSF show gram + organisms in pairs and short chains OTH OTH UNK Non-Hodgkin's lymphoma; splenectomy WAES01052672 1
0171540 06/15/2001 FL 25.0 0 .3 M 06/06/2001 Information has been received from a consumer concerning her son with no past medical history who at 16 month old in approx. 3/98 was vaccinated with MMRII. There were no concomitant medication. It was reported that her son has "autistic tendencies". It was also noted that her son was not very verbal to begin with and after he was vaccinated, he stopped speaking. Upon internal review, "autistic tendencies" was determined to be an "Other Important Medical Event". Additional information has been requested. Y N 03/01/1998 OTH OTH NONE NONE WAES01060018 1
0171542 06/15/2001 FL 22.0 F 05/05/2001 Information has been received from a registered pharmacist concerning her mother's approx. 22 year old female niece who was vaccinated with MMRII "as a child". She could not report any specifics on the date of the vaccination, the lot # or the name of the pediatrician who administered the vaccine. She reported that the pt received the vaccine "when she was still in a walker". The registered pharmacist reported that the pt was a "dry birth" and that the pt was "fine" until she received her MMRII vaccine. The registered pharmacist reported that the pt developed neurological problems. She reported that the pt "has a mind of a 3 year old" and has learning disabilities. She reported that "she attends a special school for the Mentally Handicapped". The pt did not seek medical attention. Upon internal review, neurological problems was determined to be an "Other Important Medical Event". Additional information has been requested. U UNK UNK UNK UNK WAES01052874 1
0171544 06/15/2001 CA 4.0 4 F 10/25/2001 Information has been received from an RN concerning a 4 year old female, who on 5/7/01, was vaccinated with MMRII, in the leg. Concomitant therapy, also given on 5/7/01, included DPT and poliovirus vaccine. It was also reported that the pt had received her varicella virus vaccine live, on approx. 6/27/97, in the pt's left leg in which she received the MMRII, DPT, tuberculin purified protein derivative and poliovirus vaccinations became hot and swollen. On the next day, the pt's symptoms worsened and she was dx'd with cellulitis. The child was treated with cephalexin (Keflex) and subsequently, recovered from the cellulitis. On approx. 5/18/01, the pt developed a "very severe case of chicken pox with approx. 50 lesions, on the left leg around the injection site". Upon internal review the cellulitis is considered an "Other Medical Event". Additional information has been requested. F/U It was further reported that on 5/10/01 she was seen again and that the area was more extensive. As of 5/17/01, the cellulitis was resolving. Subsequently on 5/24/01 the pt recovered. It was also reported that the pt had rec'd one dose of varicella virus vaccine live (site unknown) at one yr of age on approximately 6/27/97 and on approximately 5/17/01 developed chicken pox (WAES01091138). Upon internal review the cellulitis was considered to be an other important medical event. No further info is expected. F/U states: Information has been received from a physician and an RN concerning her 4 year old white female, family member, with an allergy to sulfa, no illness at the time of vaccination and reported to be in "otherwise good health" who on 5/7/01 (also reported as 5/9/01) was vaccinated with the 2nd dose of MMRII, SC, in the right thigh (lot 637433/0149L). Concomitant therapy, that day, included the 5th dose of alum, potassium (+) diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid (Tripedia), IM, in the left thigh (lot V02998A), 1 dose of tuberculin purified protein derivative (Tubersol) (site not reported) and the 4th dose of poliovirus vaccine (IPOL), SC, in the left thigh (lot R1437). It was noted that the child was being vaccinated for kindergarten. Subsequently, on approx. 5/7/01 (also reported as 5/10/01), the pt's left leg in which she received Tripedia and IPOL became hot and swollen. On the next day, the pt's symptoms worsened. That morning, on 5/8/01, she had redness and swelling of the left thigh, was seen in urgent care and was dx'd with cellulitis. The child was treated with cephalexin (Keflex). It was further reported that on 5/10/01, she was "seen again" and that the area was more extensive. As of 5/17/01, the cellulitis was resolving. Subsequently, on 5/24/01, the pt recovered. It was also reported that the pt had received 1 dose of varicella virus vaccine live (site unkown) at 1 year of age, on approx. 6/27/97 and on approx. 5/17/01, developed chicken pox (WAES01091138). No further info is expected. Y Y 05/07/2001 05/07/2001 0 PVT OTH Tuberculin purified protein/LL NONE Allergy to sulfa ~Varicella (Varivax)~~0.00~In Patient WAES01051900 1
0171547 06/15/2001 GA 3.0 2 1 M 06/05/2001 Information has been received from a pharmacist concerning his 35 month old son, with no known allergies or past medical history, who on 5/24/01, was vaccinated with 1 dose of varicella virus vaccine live. There was no concomitant medication. On 5/28/01, the child was crying and fell "several" times. He was taken to the ER for pain in his left knee and inability to bear weight on his left leg. Diagnostic testing including CBC, sed rate and x-rays were performed (results not provided). Transient synovitis was dx'd. At the time of reporting, the child could not bear weight on his left leg due to the "extreme" pain in his left knee. The child had no hip pain. Additional information has been requested. Upon internal review, transient synovitis was considered to be an "Other Important Medical Event". Y U 05/24/2001 05/28/2001 4 Diagnostic test, X-ray on 5/28/01, CBC and erythrocyte-all were not provided UNK UNK UNK UNK WAES01052702 1
0171548 06/15/2001 VA 1.25 1 .3 M 05/05/2001 The pt experienced diarrhea, autism and leaky gut syndrome. The 60 day follow-up states autism and diarrhea. Y N 08/06/1996 10/06/1998 791 PVT OTH NONE NONE NONE fever~DTP (no brand name)~1~0.00~In Patient 1
0171549 06/15/2001 IL 1.0 1 .0 F 11/23/2000 The first symptoms appeared on 2/23/98 which were fever, vomiting diarrhea, dehydration. These occurred immediately following; a loss of eye contact and interest in engagement with others, repetitive movements and speech, echoalic speech, insomnia, destructive behavior without remorse or understanding of what was done. FOLLOW UP information received on 08/02/02 states, "Autism-socially impaired, sensory integration dysfuntion, speech delay, self-regulatory dysfunction". Y N 02/11/1998 02/23/1998 12 Guilliam autism scale, neuro exam - diagnosis of autism PVT PVT NONE cold NONE 1
0171550 06/15/2001 NJ 0.4 0 .4 F 06/09/2001 Within 12 hours of receiving vaccine, patient experienced generalized tonic-clonic seizure lasting several minutes. She recovered fully. Y Y 06/05/2001 06/06/2001 1 CBC, Chem 20, CAT scan - all wnl PVT PVT None Heart murmur at age 1 month-benign by echo 1
0171551 06/15/2001 OK 1.0 1 .0 F 04/27/2001 Patient developed a fever and little red blotches about 10mm in size. Y 04/17/2001 04/25/2001 8 None UNK UNK Connaught IPPD, lot #C0153AA, placed on left forearm ~Measles + Mumps + Rubella (MMR II)~1~0.00~In Sibling 1
0171552 06/15/2001 IL 3.0 3 M 06/06/2001 Patient's entire deltoid area became red, swollen, painful and hot to touch approximately 12 hours after injection. A small blister approximately 3cm from injection site was also noted. He was treated with Tylenol and ice. U 06/04/2001 06/04/2001 0 None PVT OTH None None 1
0171553 06/15/2001 FL 1.5 1 .5 M 06/14/2001 Patient developed cellulitis, redness, heat and swelling on right thigh secondary to injection. Y U 06/12/2001 06/13/2001 1 None PVT PUB None None None 1
0171554 06/15/2001 MO 0.2 0 .2 M 06/05/2001 Patient developed inconsolable screaming for 1.5 hours. His left thigh developed mild redness and warmth to the touch. Y Y 06/05/2001 06/05/2001 0 PVT PVT Gaviscon, Zantac nasal congestion 1
0171555 06/15/2001 IL 0.5 0 .5 F 06/07/2001 Patient developed a temperature of 103.8 and slight swelling at injection site. Y 06/05/2001 06/06/2001 1 PUB PUB stuffy nose 1
0171556 06/15/2001 DE 12.0 11 M 06/11/2001 Patient became dyspneic 30 minutes post immunization. He was seen in the ER where questionable wheezing was noted. He was given prednisone and albuterol with rapid relief. Y Y 05/14/2001 05/14/2001 0 PVT PVT None None 1
0171557 06/15/2001 WA 27.0 F 06/06/2001 Patient developed painful upper arm in the deltoid area secondary to vaccine. She also complained of weakness, soreness of the legs, generalized malaise and muscle aches. She was offered Tylenol. U 06/05/2001 06/05/2001 0 None OTH OTH Allegra, Flonase, albuterol None exercise induced asthma, rhinitis, environmental allergies (cats and dogs) 1
0171558 06/15/2001 PA 4.0 1 .3 M 06/08/2001 Patient developed chicken pox. 01/06/1998 06/07/2001 1248 PVT UNK None 1
0171559 06/15/2001 OK 30.0 30 F 06/06/2001 Patient developed an area of redness, swelling and warmth at injection site. 06/04/2001 06/05/2001 1 None MIL MIL Loestrin None None 1
0171560 06/15/2001 ME 5.0 5 M 05/30/2001 Patient developed a rash on arm approximately 3" by 4" in size. He also had a hard lump approximately the size of a dime and discomfort in the upper arm. He was treated with Benadryl. Y 05/24/2001 05/25/2001 1 PVT PUB 1
0171561 06/15/2001 CA 6.0 4 F 06/08/2001 Approximately 6 hours post vaccine, patient developed redness and pain in upper arm. She was seen in the clinic on 6/8/01 and had an 11 x 11 cm red, warm area. She was given ibuprofen for pain and Keflex. U 06/06/2001 06/06/2001 0 None PUB PUB None None None 1
0171562 06/15/2001 27.0 27 M 06/04/2001 Patient developed Bell's Palsy approximately 4 hours after receiving typhoid vaccine. Symptoms have not worsened or improved since then. Y U 06/01/2001 06/01/2001 0 MIL UNK Claritin, Allegra, Flonase, Sudafed None seasonal allergic rhinitis 1
0171563 06/15/2001 CA 5.0 5 F 04/28/2001 Approximately 4 hours post vaccine, patient developed redness, induration and warmth in upper arm which spread to involve entire outer aspect of upper arm by 4/27/01. Patient was given Keflex for rule out cellulitis. Telephone call to patient's mother on 4/28/01 revealed the redness had lessened. Y 04/25/2001 04/25/2001 0 None PUB UNK None 1
0171564 06/15/2001 AZ 13.0 13 F 06/12/2001 On June 7, patient developed pox-vesicular spots on face, head and buttocks which crusted over in 5 days. On June 9, patient developed localized reaction at site characterized by a hard, red, bluish area 2" in diameter. Lidocaine spray decreased the redness. U 05/24/2001 06/07/2001 14 PUB PUB AZ0121 1
0171565 06/15/2001 AZ 12.0 12 F 05/08/2001 Within 20 minutes of receiving vaccine, patient complained of passing out, headache and dizziness. Her pupils were slightly dilated and her color was pale. She had occasional tremors to the right hand. Y 05/04/2001 05/04/2001 0 None UNK PUB Pepto Bismol Abdominal pain None AZ0120 1
0171566 06/15/2001 TX 1.8 1 .8 M 06/08/2001 Patient developed fever immediately following Hib. 06/04/2001 06/04/2001 0 PVT PVT 1
0171567 06/15/2001 WA 53.0 53 F 06/06/2001 No data provided. Y 05/21/2001 05/22/2001 1 MIL MIL estrogen, Elysine, vitamins, Augmentin strep throat Allergy to codeine 1
0171568 06/15/2001 VA 29.0 29 M 06/07/2001 Approximately 30 minutes after vaccine, patient developed headache. Then he began with nausea and vomiting accompanied by fever and chills. Patient had diarrhea throughout the night. Y Y 05/30/2001 05/30/2001 0 PUB PUB None None VA01013 1
0171569 06/15/2001 WI 52.0 52 U Approximately 30 minutes after receiving vaccine, patient developed a feeling of warmth at the back of the throat, some throat tightness and tongue swelling. Patient was given Benadryl. Y Y 05/30/2001 05/30/2001 0 5/31 X-ray soft tissue lateral neck-neg OTH PVT Dyrenium, Dilacor, Maxzide, potassium, Coumadin, dicloxacillin RUE abrasion, early cellulitis Allergy to Ceclor 1
0171570 06/15/2001 WI 51.0 51 F 06/05/2001 Patient developed chills, fever and aching. She complained of fatigue and swelling in injection area the size of a tennis ball. On exam 6/6/01 there was no visible or palpable lesion at site of injection. Y U 05/27/2001 05/29/2001 2 PVT PVT Prinivil, Zoloft, Remeron cellulitis from puncture wound tinea versicolor 1
0171571 06/15/2001 CA 3.0 3 M 06/13/2001 developed red, pruritic warm swelling of left upper arm with erythematous induration. Treated with Cephalexin and Benadryl. Y 06/05/2001 06/06/2001 1 PUB PUB NONE URI language delay, caries 1
0171572 06/15/2001 CA 5.0 5 M 06/13/2001 The pt experienced probable cellulitis, was warm, red, tender around injection site on arm. Treated with Cephalexin. Y 05/29/2001 05/30/2001 1 NONE PUB PUB NONE viral pharyngitis PPD diagnosed 1
0171573 06/15/2001 MI 1.25 1 .2 F 06/06/2001 The pt's right leg swelled from the knee to the hip. Y 05/15/2001 05/17/2001 2 PVT PVT 1
0171754 06/18/2001 OR 0.3 0 .3 F 06/11/2001 Pt expired. Infant found unconscious and unresponsive. Two hours earlier infant was checked on by mother and grandmother and was alive. The infant had well baby check-up and immunizations the previous day. Mother considered infant irritable after immunizations and gave her a dose of non-prescription tylenol. Autopsy states cause of death as SIDS. Y 01/11/2001 N 01/10/2001 01/11/2001 1 PVT PUB NONE NONE NONE 1
0171755 06/18/2001 CA 1.0 0 .9 M 06/11/2001 One month post vax, the pt experienced right heart failure, pulmonary hypertension. Y 05/30/2001 N 02/20/2001 03/22/2001 30 Too great to enumerate in this office. PVT UNK NONE transient splenomegally 1
0171758 06/18/2001 GA 1.08 1 .1 M 05/21/2001 Child received varivax and MMR on 5/10/01 and the next day, mom noticed that child was somewhat lethargic and had difficulty standing with support. He was hospitalized and observed to recover uneventfully, in 24 hours. Y 1 Y 05/10/2001 05/11/2001 1 CT scan was abn with a mild increase in ventricular fluid UNK UNK NONE Nasal congestion Chronic nasal congestion; 34 week gestation with IUGR (intrauterine growth retardation (restriction) birth weight-1045gms; Hypospadias 1
0171759 06/18/2001 MI 30.0 30 F 06/13/2001 Bedridden for 3 days. Had sudden onset of joint pains, which continues today. Had vertigo, dizziness, migraines, ear infections and worsened allergies. Incapacitated for 1 year and currently have chronic symptoms. Since receiving that Rubella vaccine, I have never been well nor without pain. I am currently seeking a medical retirement from work. The 60 day follow-up states arthritis (disabling arthritis); continue to have ear infections, fluid in the ear, vertigo, dizziness more than twice per year; very fatigued from pain. My children when vaccinated suffered chronic/acute ear infections and upper respritatory infections. After 1 year with no vaccinations-children were rarely ill. Note: Since receiving that vaccine, I have never been well without pain. I am currently seeking medical retirement from work. I am not pregnant and I understand I should not be pregnant for at least 3 months. I therefore give my consent to the physician to give me a rubella vaccine. Follow up on 08/16/2001: "Patient never received the vaccine at this office and there are no adverse reactions noted in her chart." Follow up on 09/12/2001: "This note is to inform you that on 12/03/1996, one of the tenants in the building moved out and left the heat turned off. We did not know this until we went to the basement and it happened. Apparently the pipes had broken. All of the records in the two rooms were wet. Some of them were just, repeats of the previous. I am very sorry that this happened, we will not be able to complete this file. If I can be of any more help in this matter, please feel free to contact the office. Thank you for your understanding." Y N 07/20/1982 07/20/1982 0 Xray-showing no arthritis; blood work-all nml PVT UNK NONE allergies Allergies; mild scoliosis 1
0171760 06/18/2001 0.2 0 .2 M 06/14/2001 Information has been received from a physician concerning a healthy 9 week old haemophilus b conjugate vaccine + hepatitis b vaccine recombinant (yeast) )+(o.5ml) (lot 631661/1291J). Concomitant vaccinations on 2/7/00 included 1 dose, SC, in the right thigh, of poliovirus vaccine inactivated (IPOL) (lot P0823) (0.5ml) and 1 dose, IM, in the left thigh of diphtheria toxoid/pertussis vaccine/tetanus (lot 4676741) (0.5ml). It was also noted that on 2/7/00, the pt received 1 dose, in the left thigh, of hepatitis b vaccine recombinant (yeast) (MSD) (lot 633506/1527J) (0.5ml). On 2/10/00, the pt experienced angioedema affecting all 4 extremities, fever, irritability and soreness. The pt recovered after 2 weeks of steroids. The pt had similar experience following exposure to MMRII (MSD) (WAES 01050238). Upon internal review, the pt's experiences were considered to be "Other Medical Events". Additional information has been requested. Y Y 02/07/2000 02/10/2000 3 PVT PVT UNK U2001007871 1
0171762 06/18/2001 MD 28.0 28 F 06/13/2001 A 28 year old female was hospitalized on 5/13/01 for Guillain-Barre-like symptoms. She was bitten by a rat on 3/15/01, in her house; the rat escaped. Her 3 month old dog was bitten by a rat (maybe the same one that bit the pt) and the dog died. No biopsy on the dog was performed, so the cause of death was unknown. The pt received her first dose of RabAvert on 3/20/01 and 9.5ml of human rabies immune globulin. She received subsequent RabAvert doses on 3/23/01, 3/28/01, 4/5/01 and 4/18/01 with no notable adverse drug reactions. On 5/13/01, the pt was hospitalized with numbness, weakness and tingling in her legs, and numbness in both hands. There was no weakness in her upper body. She was unable to walk and was falling to either side. A computed tomography scan of her head was negative. She had no history of pain. The pt was transferred to another hospital and her symptoms remained the same. She was positive for descending hypesthesia in both legs and toes. Her CSF was normal and creatine phosphokinase (CPK) lever was normal. The pt was dx'd with Guillain-Barre-like symptoms. She still had her reflexes present. No medications were given to treat the adverse events. Follow-up information was received on 5/31/01. The pt received RabAvert on 3/15/01, 3/20/01, 3/23/01, 3/28/01, 4/5/01, and 4/18/01. She received 9.5ml of BayRab (human rabies immune globulin) on 3/15/01. On 5/12/01, she went to the ER due to increasing numbness and weakness in both legs. She was unable to walk and tended to fall on either side. She was admitted, but transferred to another hospital on 5/15/01. Physical exams from 5/12/01 to 5/17/01 showed a variable decrease in lower extremity strength, otherwise the exams were normal. The pt was dx'd with possible conversion disorder and discharged on 5/17/01. The pt had agreed to undergo psychological evaluation and she is currently being referred for psychological treatment. Y Y 5 N 04/18/2001 05/12/2001 24 LP; MRI of spine; EMG/Nerve conduction studies; computed tomography of head and spine; CBC; UA; Creatine kinase and thyroid stimulating hormone tests were all nml. PUB PUB BayRab (human immune globulin) Rat bite Rat bite EM20010643 1
0171763 06/18/2001 GA 1.0 1 .0 M 06/12/2001 A 13 month old B/M who stopped talking on 4/25/01, 2 days, post vax. On 4/19/01, had a fever. Y Y 04/26/2001 04/28/2001 2 CBC-OK; UA-(-); PVT OTH URI On 4/19/01 had a fever/viral illness and mild otitis media 1
0171764 06/18/2001 CA 0.75 0 .9 F 06/09/2001 The pt experienced cellulitis and abscess at the site of injection. Y 3 Y 05/22/2001 WBC-20k with 60 S 2 B-Strep pyogenes isolated;Westerngren Sed rate increased at 63 PVT PUB NONE 1
0171765 06/18/2001 VA 0 .3 U The pt experienced a fever or 103 for 2 days, a rash that was diffuse for several hours. URI - 2 days post vax. Y Y 04/30/2001 04/30/2001 0 NONE PUB PUB NONE URI formula intolerance 1
0171766 06/18/2001 TX 1.6 1 .6 F 06/14/2001 The child was noted to have erythema with edema and redness in the rash occurring a few minutes after Prevnar administration. U 06/14/2001 06/14/2001 0 PVT PVT otitis media, bronchitis 1
0171767 06/18/2001 WV 1.7 1 .7 M 06/13/2001 The pt was taken to the ER after the vax. Mother stated the pt did not move or talk for three hours. She said his eyes were open, but he was limp. The MD did not give him any medication. The doctor thought he had a virus. The mother came in on 6/7/01 to received the 2nd dose that is when she told the nurse what happened with the 1st dose. Y Y 03/14/2001 03/14/2001 0 PUB OTH NONE WV0108 1
0171768 06/18/2001 OR 1.5 1 .5 F 06/08/2001 The pt experienced a febrile seizure 24 hours post vax. Y Y 06/06/2001 06/07/2001 1 NONE PVT PUB Amoxicillin bilateral otitis media fever~DTaP (no brand name)~3~0.00~In Patient 1
0171769 06/18/2001 NY 1.7 1 .7 U The pt experienced hives, erythema multiforme on the chest and arms. Symptoms resolved within 36 hours. Y 06/06/2001 06/07/2001 1 NONE PVT PVT NONE 1
0171770 06/18/2001 OK 4.0 4 M 06/11/2001 The pt broke out with a rash on 6/8/01. The rash was located under both arms, the groin and private area. The pt was given Hydroxyzine. Y Y 06/06/2001 06/08/2001 2 CBC PUB OTH 1
0171771 06/18/2001 VA 4.0 4 M 05/31/2001 4-5 hour post vax, the pt developed a fever, a 1 1/2 inch area of redness and induration on left arm. Gave Advil, Temp at 5:00am was 99. Redness and induration in left arm has gradually increased to 7". The child does not feel ill and has normal activity. U 05/29/2001 05/29/2001 0 PUB PUB NONE NONE NONE VA01016 1
0171772 06/18/2001 SD 1.6 1 .6 M 05/30/2001 The pt experienced a raised red area around the injection site on right thigh. States areas lasted for 4 days before going away. States that PM also ran a temp of 103.4. Temp decreased over 2 days and was gone at the end of 2 days. Did not take to doctor Y 04/24/2001 04/24/2001 0 NONE PUB PUB NONE NONE Amoxicillin 1
0171773 06/18/2001 CA 57.0 56 F 06/11/2001 The pt experienced severe vertigo, nausea, tiredness for over 1 1/2 weeks. This reoccurred several times over the next 5 months. Y Y 11/11/2000 11/12/2000 1 NONE PUB PVT Synthroid, Premarin, Progestin, multivitamins, DHT - vitamin D NONE nephrectomy, 1
0171774 06/18/2001 CA 9.0 9 M The pt experienced a several minute generalized tonic/clonic seizure with post-ictal period. Taken to the ER. The pt was febrile at the time. The pt had a positive exposure to varicella. The pt now has pox on 6/11/01. Y Y 05/29/2001 06/07/2001 9 CBC/lytes - nml PVT PUB NONE NONE 1
0171775 06/18/2001 PA 23.0 F 06/13/2001 The pt experienced hive like rash on upper extremities, neck, chest. Given oral Benadryl and then injected Benadryl. Y 06/12/2001 06/12/2001 0 OTH OTH sulfa allergy 1
0171776 06/18/2001 FL 3.0 0 1 M 06/15/2001 Patient received varicella vaccine 11/20/98 and was diagnosed with chicken pox on 6/15/01. Y 11/20/1998 06/11/2001 934 PVT OTH None None 1
0171777 06/18/2001 NC 4.0 4 M 06/14/2001 Patient developed an approximately 2 by 5 cm size inflamed, erythematous area that blanches. 06/12/2001 06/14/2001 2 PVT UNK Connaught PPD, lot #C0519AA, placed in right arm None None 1
0171778 06/18/2001 GA 1.0 1 .0 M 06/14/2001 The patient was given varicella vaccine on 5/24/01. The patient developed a fever that lasted from 6/9/01 through 6/11/01. The patient developed a vesicular rash on trunk which started on 6/12/01 and mild pruritus. Y 05/24/2001 06/09/2001 16 None PVT PUB None wheezing 1
0171779 06/18/2001 GA 4.0 4 M 06/14/2001 Patient developed swelling and erythema of left mid-thigh. Left thigh had a circumference of 33 cm as opposed to 30 cm for right thigh. Y 06/13/2001 PVT UNK None 1
0171780 06/18/2001 OK U No data recorded. Y MIL MIL IPPD, Celexa None None 1
0171781 06/18/2001 AL 4.0 4 F 06/11/2001 Patient developed swelling, redness, blisters and itching of the left arm. The symptoms were lower than the injection site. Y 06/08/2001 06/09/2001 1 None PVT PVT None None None 1
0171782 06/18/2001 PA 4.0 4 F 06/11/2001 Patient developed a 16.5 x 13.5 cm area of erythema and induration at injection site 72 hours after DTAP. Y Y 06/08/2001 06/09/2001 1 PVT PVT None None None ~Measles + Mumps + Rubella (MMR II)~1~1.25~In Sibling 1
0171783 06/18/2001 WI 46.0 46 F 06/08/2001 Patient developed swelling, itching and warmth of arm around vaccine site. She took Benadryl. Y 06/06/2001 06/06/2001 0 None PVT PVT Synthroid, Glucophage, Premarin, Lipitor None Mercury allergy, hypothyroidism, diabetes mellitus type 2, hyperlipidemia 1
0171784 06/18/2001 CA 12.0 12 F 06/11/2001 Within a few minutes of receiving vaccine, patient developed chills, headache, dizziness, nausea and agitation that lasted 30 to 45 minutes. She recovered with no treatment. Y 06/06/2001 06/06/2001 0 PVT OTH None None None 1
0171786 06/18/2001 MA 5.0 5 F 06/08/2001 Patient developed a 5.5 x 5.5 cm area of induration and erythema on right deltoid in the area where DTAP dose was given. Y 06/06/2001 06/08/2001 2 None PVT PUB None None Amoxicillin allergy 1
0171787 06/18/2001 SC 32.0 32 F 05/14/2001 Patient developed a hard, sore knot on the left arm. U 05/07/2001 MIL MIL birth control 1
0171788 06/18/2001 MD 1.5 1 .5 F 06/11/2001 Patient noted to have an extensive papular, erythematous rash in varying stages from papules to scabbing. Onset was 3 days prior to office visit on 6/8/01. Patient diagnosed with chicken pox on 6/8/01. Y 04/18/1996 06/08/2001 1877 PVT PVT None 1
0171789 06/18/2001 NC 4.0 4 F 06/11/2001 Patient noted to have localized redness and swelling on left thigh on 6/7/01. Patient advised treatment with warm compresses and massage to area. U 06/05/2001 06/07/2001 2 PVT PUB 6/5/01 Connaught Poliovax, lot #T0562, SC in RL, 0 previous doses 1
0171790 06/18/2001 NC 4.0 4 M 06/12/2001 Patient developed a 7-8 cm area of diffuse erythema, swelling and slight tenderness on right deltoid. Patient was advised to treat with warm compresses to area. U 06/04/2001 06/06/2001 2 PVT PUB Singulair, Zyrtec, Ventolin inhaler None allergic rhinitis 1
0171791 06/18/2001 NC 5.0 5 M 06/12/2001 Generalized seizure lasting 10 minutes. No prior history. Previously healthy child. Y Y 05/18/2001 06/11/2001 24 lytes - nml, CT Scan - nml PVT PUB NONE NONE 1
0171973 06/19/2001 NH 0 .0 F 06/18/2001 SIDS Y 05/27/2000 N 05/07/2000 05/27/2000 20 PVT PUB NONE ? Murmur (5/23/01) -(meconium stained fluid) NH0118 1
0171974 06/19/2001 WA 1.25 1 .3 M 03/23/2001 Came in the ER with complaint of fever, low appetite, vomiting, had seizure in ER and unstable. Transport to other facility was arranged and pt expired during transport. Pneumococcal sepsis and meningitis. Y 03/21/2001 N 03/13/2001 03/21/2001 8 CBC; UA/UC; Chem Panel; Blood culture; Head CT; Abdominal CT; CXR PVT PUB Hg C trait; Septic elbow; Septic hip; anemia; inguinal hernias; Atopic dermatitis 1
0171975 06/19/2001 MS 0.5 0 .5 F 06/13/2001 Received phone call on 6/13/01 from coroner's office regarding child that had received immunizations on 6/12/01 and had expired on 6/13/01? Baby was found dead per mother in crib. Denies any previous illness except "teething". Autopsy report states COD as SIDS. F/U: coroner's report states this is a Caucasion female Y 06/13/2001 N 06/12/2001 06/13/2001 1 autopsy - report pending; autopsy states-petechiae in thymus, heart and lungs; acute congestion of sinuses; lymph nodes reveal changes of reactive lymphoid hyperplasia; sections of lung reveal pulmonary vascular congestion and edema with focal atelectasis; hepatomegaly and congestion (renal and splenic) PUB PUB Tylenol drops NONE Denies any previous illnesses except teething MS01024 1
0171976 06/19/2001 MD 26.0 26 F 06/13/2001 Received influenza 11/30/00 and 1 week later, had right shoulder numbness that progressed into weakness, paresthesia, "started bumping into things". Also, had right side weakness in right leg "not as had in arm". Dx: Transverse Myelitis on 12/27/00. The 60 day follow-up states that pt last seen on 08/15/2001 and condition has improved (resolved). Y Y 3 Y 11/30/2000 12/06/2000 6 MRI-revealed lesion at C3; LP; Evoked potentials; multiple Blood tests (looking for infection and auto immunity) MIL MIL OCP's NONE Seasonal allergic rhinitis; atopic dermatitis 1
0171977 06/19/2001 NV 1.25 1 .3 M 06/11/2001 Fall, not witnessed, seizure and pulmonary aspiration with possible mild closed head injury. Y Y 3 Y 06/01/2001 06/07/2001 6 EEG: MRI Brain: CT Brain-all nml PVT PUB NONE NONE 1
0171978 06/19/2001 CA 5.0 F 06/13/2001 Information has been received from a pt's mother concerning a 5 year old female with insect bite allergy who on 3/26/01 was vaccinated with MMRII. On 3/26/01, the pt was also vaccinated with DPT and poliovirus vaccine. Within 3 days, on 3/29/01, the pt's arm became swollen. In 4/01, the pt came down with 103F fever. On 5/10/01, the child was hospitalized and was released on 5/21/01. The child was readmitted on 5/23/01 and released on 5/25/01. The mother stated while the child was in the hospital, she was "dx'd with Henoch-Schoenlein-Purpura". Additional information has been requested. Y Y U 03/26/2001 03/29/2001 3 Temperature-103F on 4/01 UNK UNK Insect bite reaction WAES01060529 1
0171982 06/19/2001 TX 11.0 11 F 06/18/2001 This report describes hives, itching and swollen eyes in an 11 year old female who received hepatitis B vaccine recombinant (Engerix-B) for prophylaxis of Hep-B. This report was received from the vaccinee's mother and has not been verified by a physician or other health care professional. The vaccinee had seasonal and animal allergies, but did not have asthma. Her concomitant medications included loratadine (Claritin) and mometasone furoate (Nasonex). On 1/3/00, the vaccinee received her 1st dose of Engerix-B. Two to three hours, post vax, she experienced itching and hives "all over face and neck". The vaccinee was treated with an "itch cream" (NOS) "which helped a little". The hives resolved after approx. 3 weeks. The pt was seen by an allergist, who instructed her to take Claritin and Benadryl prior to the administration of the 2nd dose of Engerix-B. On 6/11/01, the pt received her 2nd dose of Engerix-B at the allergist's office. Per the mother, "within hours" the pt's eyelids turned "blood red" and were "swollen shut". The pt fell asleep and "was not easily aroused". The mother thought that the drowsiness was related to Benadryl. The allergist was called, the pt was taken to his office, where she was treated with epinephrine on 6/11/01. As of 6/12/01, symptoms were slowly resolving. This report is considered "Medically Serious" due to the intervention required. Y N 06/11/2001 06/11/2001 0 OTH OTH Claritin, Nasonex, Benadryl Allergies to animals and seasonal allergies 20010143311 1
0171986 06/19/2001 NY M 06/14/2001 An attorney alleged that a male infant received Tri-Immunol vaccine on 8/18/94. Within hours of receiving the vaccine, the infant suffered neurological illness. It is alleged that, as a result of Tri-Immunol administration, the infant suffered severe and permanent harm, including but not limited to, a seizure disorder, convulsions, encephalopathy, mental retardation, hypotonia, coordination problems, ataxia, lethargy, developmental delay, physical and mental pain, suffering and emotional distress. Y N 08/18/1994 08/18/1994 0 UNK OTH OTH UNK UNK UNK HQ2016513JUN2001 1
0171989 06/19/2001 VA 0.5 0 .5 M Temperature of 104F. Y Y 06/14/2001 06/14/2001 0 N/A PVT PVT N/A N/A 1
0171990 06/19/2001 CA 1.0 1 .0 F 05/24/2001 Lt arm redness, swelling and induration. Y 05/22/2001 05/24/2001 2 PUB PUB NONE NONE CA010059 1
0171991 06/19/2001 CA 1.7 1 .7 M 05/24/2001 Rt arm, redness, swelling, induration U 05/22/2001 05/24/2001 2 PUB PUB CA010060 1
0171992 06/19/2001 NY 1.6 1 .6 F 06/08/2001 Moderate swelling of R anterior thigh less than 12 hrs post Prevnar #4, swelling times 2 days. Y 05/24/2001 05/24/2001 0 PVT PVT None None 1
0171993 06/19/2001 GA 0.2 0 .2 M 06/12/2001 A max. temp of 102.2F right about 12 hrs post vaccine. Y 06/11/2001 06/11/2001 0 PVT PUB None None 1
0171994 06/19/2001 MS 0.3 0 .2 F 06/06/2001 Mother reports child had screaming, increased temp and stiff neck after immunization. They went to ER. Test were negative for meningitis. ER physician told them the reaction was to Prevnar. Y Y 04/18/2001 04/19/2001 1 PUB PUB None None MS01022 1
0171995 06/19/2001 WI 0.3 0 .3 M 06/13/2001 Multiple erythema pinpoint papules on the trunk. 3x3 induration with erythema papule in the center located in the Rt upper thigh. Y Y 06/11/2001 06/12/2001 1 PUB PUB 1
0171996 06/19/2001 MS 0.3 0 .3 F 06/14/2001 Rash began day after receiving immunization, no fever, no treatment, observation advice and benadryl as needed. Viral exanthium VS reaction to immunization. Rash continues today. Child is happy and playful. N 06/11/2001 06/12/2001 1 PVT PVT None None None MS01025 1
0171997 06/19/2001 CA 1.08 1 .1 M 05/25/2001 Given tylenol for slight fever L leg swollen with red spot,irritable in afternoon, fever went to 103.6F down to 102.9 and back to 103F, down to 100F today. Stopped walking on Thursday L leg bruise, hard swollen to size of silver dollar. Y Y 05/22/2001 05/23/2001 1 Mom took baby to PMD and was given Penicillin for ear infection. Baby given 1st dose, started improving dramatically. ? finish RX. PUB PUB Unknown None Heart murmur at birth, allergic to milk products. CA010056 1
0171998 06/19/2001 IL 0.2 0 .3 F 06/05/2001 Mother states baby had difficulty breathing, eyes rolled back, skin color turned bluish. Mother called 911. States temperature at the hospital 105F rectal. Mother also states baby's color was yellow. Y Y 04/03/2001 04/03/2001 0 Blood tests, x-rays PUB PUB None None IL01021 1
0172000 06/19/2001 CA 1.7 1 .6 F 06/01/2001 Ma called. Stated child had fever times 3 days, did not take temperature. Pt being followed for (+) PPD. Chest x-ray read on 5/23 dx probable bronchitis. Advised to see physician on 5/30/01. Seen by MD on 5/30. Dx febrile episode? vaccine related. Afebrile times 2 days. Recommended spacing next vaccine 6/1/01. Pt afebrile. Y Y 05/18/2001 05/18/2001 0 Chest x-ray 1. probable bronchitis, 2. RLL density which be due to vascular markings emphasized from mild rotatide? to the left clinical ? is recommended to R/O infiltrate. PUB PUB Possible bronchitis, (+) PPD None CA010053 1
0172001 06/19/2001 TN 0.3 0 .3 F 06/08/2001 Fever < 104 times 24 hrs. watery stools. tylenol x 24 hrs. Rocephin 250 mle x 1 dose Y Y 06/04/2001 06/04/2001 0 PVT PUB Nystatin Oral thrush TN01023 1
0172002 06/19/2001 CA 0.5 0 .5 F 06/12/2001 Pain, redness, swelling, rash within 24-48 hrs of vaccination. Slight fever. Involved both thighs. The follow up stater per MD's notes-equal amt. of swelling and redness in both thighs-impossible to determine which vaccines caused reaction in right thigh. Y 06/07/2001 06/08/2001 1 None PVT PVT No None 1
0172003 06/19/2001 NC 0.7 0 .7 F 06/13/2001 Pt grandmother states around dinner time pt became very sleepy hard to keep awake, after going to sleep awoke after about 30 minutes. Vomiting and vomited several times from then until midnight. No elevated temp or other s/s next morning. Pt was well and has had no symptoms since. Y 06/11/2001 06/11/2001 0 PUB PUB 1
0172004 06/19/2001 MI 0.17 0 .2 F 06/13/2001 Patient was seen in office for hives on face (chin, cheeks only). Dr thought possible contact dermatitis. Pt has been in since 4/27/01 for her 4 months series and received Pneumococcal #2 without problems. Y 02/27/2001 03/01/2001 2 PVT PVT No well baby 1
0172005 06/19/2001 NY F 06/09/2001 24 hrs after vaccine of Prevnar site swollen, hard,hot and red. U 06/07/2001 06/08/2001 1 None OTH OTH PPD No NKAD or Birth defects 1
0172006 06/19/2001 OH 1.0 0 .8 M 06/12/2001 6/8/01 cold symptoms. Fever 105.1F irritability. diarrhea. blood culture positive for Strep pneumoniae (pain sensitive) Pt had received 3 doses of Prevnar. Received ceftniaxone times 1 then po Augmentin. Y Y 02/27/2001 06/08/2001 101 blood culture + for strep pneumoniae. urine -neg, CxR nl, CBC - nl, UA- nl PVT PVT None None None 1
0172007 06/19/2001 CA 1.25 1 .3 M 06/12/2001 Right thigh red and swollen the evenings that patient got vaccinated and next morning pt had fever and convulsions, pt was seen at ER and diagnosed with febrile seizures. Y Y 05/11/2001 05/11/2001 0 CBC normal, Urine analysis normal PVT PVT None None Bronchiolitis 1/16/01 1
0172008 06/19/2001 KY 1.04 1 .0 F 06/14/2001 Mother called 6/14/01 and reported: evening of 5/31/01 noted rash/hive-like area on face, legs, arms, back over next 2-3 days the condition spread. Afebrile non itchy. Child was not hot and not acting sick, but hive like areas although better continue to be on back, arms, legs, especially when hot. Saw PMD 6/5 continues with hives. Y 05/31/2001 05/31/2001 0 PUB PUB KY2001044 1
0172009 06/19/2001 NY 3.0 3 M 06/14/2001 2 1/2 yr old given Prevnar on 6/6/01, 6/8/01 started to develop generalized rash. Mother took child to Hosp. Benadryl given. Seen on 6/13/01 referred to ER stat. Y 06/06/2001 06/08/2001 2 PUB PUB None Asthma 1
0172011 06/19/2001 DC 67.0 66 M 11/30/2000 Continued itching over shot site, starting 1 day post shot continuing for 3 days. Still has itching today (day #3) N 11/27/2000 11/28/2000 1 MIL UNK 1
0172012 06/19/2001 CA 12.0 12 F 04/25/2001 Fever of 103F intermittent spikes Y Y 04/18/2001 04/19/2001 1 PVT PUB Amoxicillin None - allergic rhinitis. resolving pharyngitis 1
0172013 06/19/2001 CA 29.0 29 F 05/25/2001 Pt received TD, MMR and PPD on 4/26/01 without incident, about 3 days later developed extremities myalgia and arthralgia over R side of body, as well as in L elbow, leg and hip. Also became very fatigued about 5/3/01, condition had worsened to the point where pt had pain everywhere plus a rash over body and felt febrile. No temp documented. Husband states brought pt to MCHO where saw nurse who referred to PMD for further evaluation. On 5/7/01 pt went to doctor on duty (DOD) on N Main st. Told that could be reaction to, given Allegra and told to use with tylenol for arthralgia. On 5/14/01 was to see a FP doctor who did exam and lab test. Told the condition could be related to stress. Today pt c/o scattered pain over mainly trunk. Also says left side of mouth hurts when eating/swallowing and feels generalized fatigue . Y U 04/26/2001 04/29/2001 3 Lab work pending PUB PUB see attached note (nothing with medications attached) None None CA010052 1
0172014 06/19/2001 SC 1.01 1 .0 F 06/12/2001 Mom put child down for nap. Mom heard child playing and went in to check on her, Mom states that when she picked child up she was burning up. She took her Temp it was 103.2, Mom said they told her this was normal after shots and just give her tylenol. Mom states after back home child fever back up to 105 eyes rolled back and child had apparent seizure activity. Mom called ER they told her this was normal. Mom continued motrin and tylenol rotating each. Dr called next day. Mom states as child she had reaction to MMR. Mom states child was on Amoxil but she stopped it until after shots given. Y Y 06/07/2001 06/07/2001 0 See attached ER sheet (nothing attached) PUB OTH None Croup cough and sore throat NKA SC0134 1
0172015 06/19/2001 NE 18.0 18 M 06/12/2001 Pt received MMR on 6/1/01. Grandmother stated on 6/3/01 pt complained of headache, temp 101-102 and nausea. On 6/4/01 there were light red raised areas on the neck and shoulders, loss of appetite, nausea, low grade temp and a headache. On 6.6.01 grandmother took child to Dr. The child was unable to see routine doctor. While seeing Dr, blood test and urine were done. The results to the blood and urine test were negative, and the doctor could not give reason for condition. On 6/8 child had red raised areas on neck, shoulders, back, chest, and arms. Blood & urine test were done again, urine came back positive with bacteria. Dizzy, headache and red spots remain. Pt taken to ER Dr diagnosed measles. Y N 06/01/2001 06/03/2001 2 Blood and urine test done 1st time negative. Test repeated bacteria reported in urine. PUB PUB None None None 1
0172016 06/19/2001 OH 11.0 11 M 05/29/2001 Cervical Lymphadenopathy, tender right greater than left. Y 05/24/2001 05/26/2001 2 NONE PVT PVT NONE NONE NONE 1
0172017 06/19/2001 NJ 2.0 2 .5 M 06/14/2001 Swelling, induration, redness from shoulder to elbow on vaccinated arm. Improved after 3 days. Y 06/09/2001 06/09/2001 0 NONE PVT PVT Burn on palms Allergic to Amoxicillin 1
0172018 06/19/2001 CA 13.0 13 F 06/04/2001 received vaccine c/o pain at time of injection same day evening c/o warmth, pain, tenderness. Increased temp in area. On 6/4/01 returned to clinic - R deltoid area warm to touch, c/o tenderness pain, swelling. Received warm/cold compresses. Move arm Y 06/01/2001 06/01/2001 0 PUB PUB NONE NONE CA010061 1
0172019 06/19/2001 CO 3.25 3 M 06/14/2001 Child received DTaP #4, on R thigh 6/12/2001. Reaction started on 6/13/01 the size of a quarter. Radiated to size of ping pong by 6/14/01. Warm to touch; raised. Tx Cefzil 250/5 6ml po qd x 10d. continue Benadryl & cold compress to reduce. Swelling & reaction. Y 06/12/2001 06/13/2001 1 PVT PVT 1
0172020 06/19/2001 4.0 4 F 06/05/2001 10 days after varicella immunization developed itchy papule vesicular grouped lesion at right central thigh. (injection site) U 05/23/2001 06/03/2001 11 MIL MIL 1
0172021 06/19/2001 CA 8.0 8 F 06/08/2001 Child developed itchy erythematous variable sized maculopapular on Lt upper arm, shoulder, upper back Rt upper chest. Pt on Benadryl and symptoms resolved within 25 minutes. No longer has rash. Y 06/08/2001 06/08/2001 0 NONE PVT PUB Fe sol oral NONE Anemia CA010062 1
0172022 06/19/2001 19.0 19 F New onset c/o itching reported approximately 1 to 2 hrs post initial Hepatitis B Vaccine with scattered erythematous papules. Was treated with antihistamine. Further vaccine discontinued. Follow up with primary doctor. U 06/01/2001 06/04/2001 3 None ordered UNK UNK Reports good health. No known prior allergy history. 1
0172023 06/19/2001 VA 50.0 50 F 06/11/2001 Received 3rd Hep B on 4/25/01. Noticed chills no fever for 1-2 wks. Rash, hives, joint pain, swelling in hands and legs. Rash is still present. Cortisone gives temporary relief. Cefntee ? 10mgm times 1 week gave a little relief. Advil taken for pain. Still c/o pain in legs. Also c/o pin pricking sensation in arms and legs. Y N 04/25/2001 04/30/2001 5 NONE OTH PVT NONE NONE VA01017 1
0172024 06/19/2001 CA 1.08 1 .1 M 06/05/2001 7 days after rash on legs bigger and more concentrated in diaper area. Increased temp, motrin helped. Now is itching. Few on trunk and upper extremities. Dx as C.P. by MD ?. Y Y 05/24/2001 05/31/2001 7 PUB PUB CA010058 1
0172025 06/19/2001 CA 61.0 61 F 06/05/2001 24 hours after vaccination pt had nausea, fatigue, malaise, headache, and myalgia which lasted for five days. Y 05/22/2001 05/23/2001 1 OTH PVT NONE CA010057 1
0172026 06/19/2001 CA 4.0 4 F 05/15/2001 Redness, tender, swelling at L thigh noted 5/15/01. 8x8cm anterior patch + erythema, possible cellulitis, possible local reaction. Y U 05/14/2001 05/15/2001 1 PUB PUB NONE NONE Amoxicillin, Sulfa CA010055 1
0172027 06/19/2001 AR 1.25 1 .2 F 06/01/2001 Shot given in left arm. Pt had MD appointment after vaccines were given, arm was swollen, as reported by physician's office. Mom swelling was gone within an hour, mother was unsure of why physician was concerned. Tylenol was only med given. Y 06/01/2001 06/01/2001 0 PUB PUB NONE NONE NONE 1
0172028 06/19/2001 VA 20.0 20 M 06/11/2001 After Hep B injection pt c/o nausea, burning at site with a feeling of electric shock. c/o nausea pale with slight seizure activity, tonic-clonic with upper extremities noted. Pt became unresponsive, lowered to floor with both feet elevated. Immediate response with pt speaking laughing 10:30am b/p 106/60 HRR 76, APR 16,10:40 140/68, 11:00 112/60, 11:11 106/60, 11:14 sitting 104/64, sitting in chair 11:16 98/60,P 60 HRR A.P. & radial R 18, no SOB or angina noted. Color returning to cheeks cold wash cloth applied to forehead after pt lowered to floor. Noted 3 red splotches on chest without induration. No hives. Pt denied felling lightheaded, dizzy, nauseated or ill in anyway. with BP 82/58. Y Y 06/11/2001 06/11/2001 0 lab work (blood) PUB PUB 1
0172029 06/19/2001 CA 18.0 18 F 05/17/2001 Student reports noticing rash on back and chest 1 day after receiving 2nd Hep B injection. No symptoms after 1st injection. 5/17/01 T 98.7, BP 100/60, P 72 Y 05/04/2001 05/05/2001 1 CBC, STS OTH PUB Monodox for acne NONE NONE CA010054 1
0172031 06/19/2001 OK 3.0 2 .9 M 06/11/2001 Right arm swelling, redness, tenderness at immunization site within 24 hrs of immunization. Pt mother gave tylenol. Physician orders of over the counter benadryl. Resolved at site. Y Y 03/01/2001 03/02/2001 1 afebrile PUB PUB NKDA 1
0172032 06/19/2001 CA 1.5 1 .5 F 06/06/2001 Red indurated area of around vaccine site. 5" in diameter. Y 06/04/2001 06/04/2001 0 PVT PVT 1
0172033 06/19/2001 MI 1.5 1 .5 F 06/06/2001 Local reaction, warm compresses Y 06/04/2001 06/06/2001 2 PVT PVT NONE NONE 1
0172034 06/19/2001 VA 69.0 69 F 06/08/2001 Herpes Zoster (shingles) L T4-5 distal back Y 05/30/2001 05/31/2001 1 MIL MIL S/P mastectomy 1
0172035 06/19/2001 MD 40 F 8 hrs after vaccine local tenderness, took tylenol. next morning (16-18hrs post shot) local redness and pain redness did not increase but persisted 2 days. Y 03/12/2001 03/13/2001 1 MIL MIL pseudoephedrine / guaifenesin Mild URI, sinus congestion NONE 1
0172036 06/19/2001 IN 1.5 1 .5 F 06/15/2001 2.5 cm area raised on left thigh. U 06/13/2001 06/14/2001 1 PVT PVT NO congestion 2/26/01, ears 1/29/01 1
0172037 06/19/2001 TN 0.75 0 .8 M 06/11/2001 Within 10 minutes of vaccine pt developed urticaria. There were no other factors to attribute the urticaria to. Y Y 05/29/2001 05/29/2001 0 NONE PVT PVT NONE NONE NONE 1
0172038 06/19/2001 FL 7.0 3 F 06/18/2001 Here in office today 6/18/01 with chicken pox on set 6 days ago. 02/12/1997 PVT PVT Cough & congestion N/A 1
0172039 06/19/2001 NC 1.06 1 .1 M 06/14/2001 Pt left office after receiving MMR #1, Varicella #1, Hib #4, 20 minutes later Mom returned with child. No tonic -clonic activity no color change, but eyes rolled in head (per Mom) child examined and examined per Dr. Y 06/13/2001 06/13/2001 0 PVT PUB NONE NONE 1
0172127 06/20/2001 TX 31.0 21 F 06/18/2001 Dx'd with autoimmune disease, systemic lupus erythematosus. History of total left hip replacement. (Pt had 2nd Engerix-B on 9/18/92 and 3rd Engerix-B on 3/10/93) Y Y N 08/21/1992 05/01/1999 2444 Several diagnostic blood tests PVT UNK NONE NONE 1
0172128 06/20/2001 GA F 06/18/2001 This pt is a mother whose primary concern is that numerous infections in her child may have been the result of her receiving the Anthrax vaccine while she was pregnant. The mother received no other vaccines while she was pregnant and was taking no concomitant medications. The mother reported that she had no previous medical conditions. The mother reported that there was a concern about the infant's femur bone growth during pregnancy as it appeared to be too short. Beginning approx. 1/23/00, the infant experienced successively thrush, respiratory syncytial virus infection, rotavirus infection, infectious mononucleosis, streptococcal throat infection, and recurrent ear infections. At the age of 2 months, he was dx'd with thrush and with respiratory syncytial virus infection at the age of 3 months. In 1/01, the infant was dx'd with rotavirus infection. He has had over 15 ear infections and while tubes were placed in his ears in 4/01, there has been no decrease in the number of ear infections. In 5/01, the infant was dx'd with infectious mononucleosis and with streptococcal throat infection on 6/4/01. Relevant tests performed include numerous unknown blood tests and a chest X-ray. The infant has been treated with various antibiotics. As of this report, he has not fully recovered. Y U 01/23/2000 Chest X-ray; numerous blood tests OTH OTH NONE NONE NONE BIT010008 1
0172130 06/20/2001 SC 33.0 33 F 05/25/2001 Painful, throbbing, aching pains in arms and shoulders. Left arm is numb feeling in my fingers, hand is weak, with burning pain, also in shoulder, arm and on left side of neck, with stinging feeling following. Deep aching pain in my muscles and shoulders. Y U 02/22/2001 03/05/2001 11 PUB UNK Depo-Provera on 3/5/01, none previously NONE 1
0172131 06/20/2001 MD 71.0 71 F 04/23/2001 2-3 days, post vax, lost appetite. Approx. 2 weeks after vaccine overwhelming fatigue, slept for 1 week. Malaise and fatigue persists. Y Y 04/06/2001 04/09/2001 3 MIL PUB chronic illness Asthma, hypothyroidism, hypertension 1
0172136 06/20/2001 OH 1.25 1 .3 M 06/14/2001 (Pneumonia) Having problem breathing, 2 days after having shots. Went to hospital 3 days after having shots. Was in the hospital for 4 days and 3 nights. Went home on antibiotics for 2 weeks and on nebulizer for a month. I then switched his doctor and he put him on more antibiotics. He then recovered in mid-March. Y Y Y 4 Y 01/31/2001 02/03/2001 3 PVT PVT None NONE None 1
0172137 06/20/2001 MI 1.7 1 .7 M 06/14/2001 Well child on 6/4/01 and received 3 vaccines. Was well until 22:00. Went to sleep and did not wake up. Evaluated at 11:00, in the clinic and could not be aroused. Sent to ER and he slowly woke up spontaneously. Recovery seems to be complete. Spiked temp of 105 degrees Y 3 Y 06/04/2001 06/05/2001 1 CT of head-(-); EEG-too sedated to be accurately read; Labs, toxicology screens-all neg PVT PUB NONE NONE Possible history of febrile seizure not confirmed. 1
0172138 06/20/2001 NY 0.2 0 .2 M 06/14/2001 Child given 3 vaccines (1st doses). Before shots given, cried hard and turned slightly cyanotic with breath holding; fine after. Given shots one at a time and did well. MD walked into room, 5 minutes later and child looked pale, face and extremities. Pulse and heart sounds strong with normal rate and rhythm. Kept him flat. Was alert and no distress. At one point cried hard and held breath and was cyanotic. Cyanosis resolved quickly but pallor lasted 20 minutes, then looked well. Sent home, followed by phone and was fine. Y Y 06/07/2001 06/07/2001 0 NONE PVT UNK NONE NONE 1
0172139 06/20/2001 TN 0.3 0 .3 M 06/08/2001 Fever <104F X 24 hours. Gave Tylenol X 24 hours. Y 06/05/2001 06/05/2001 0 PVT PUB NONE NONE NONE TN01024 1
0172140 06/20/2001 CA 2.0 2 .0 F 06/14/2001 Morning after began severe stuttering with facial tics, twitching eyes, shaking and was completely gone on the 4th day, as suddenly as it began. Dx'd over phone and given steps for stopping stuttering. Y 02/26/2001 02/27/2001 1 NONE PVT PVT NONE NONE NONE 1
0172141 06/20/2001 SC 0.6 0 .5 F 05/18/2001 Mom states client's uncle related that after immunizations on 4/10/01, client had a seizure that lasted about 1 minute. No fever until the next day. No further seizure activity after this one episode. Y 04/10/2001 04/10/2001 0 PUB OTH NONE NONE NONE SC0133 1
0172142 06/20/2001 CA 1.0 1 .0 M 06/14/2001 High fever of 102F and macular papular rash on trunk and face. Some scattered to extremities. Y U 06/05/2001 06/12/2001 7 PVT PVT PPD/Aventis/C0152AA/ID/LFA/0 previously, Augmentin, Bleph-10 BOM and Conjunctivitis NONE 1
0172143 06/20/2001 TX 0.2 0 .2 F 06/14/2001 Fever of 102 and LOC. Seen in ER, 12 hours, post vax. Y Y 06/13/2001 06/13/2001 0 PVT PVT NONE 1
0172144 06/20/2001 CO 0.9 0 .9 M 06/11/2001 Within 24 hours: papular rash at injection sites and hives over whole body. Within 48 hours: papular rash extending about 10cm from each injection site. Hives resolved with Benadryl. Y Y 06/06/2001 06/06/2001 0 PVT OTH triamcinolone cream; Motrin Eczema Eczema 1
0172145 06/20/2001 OH 1.25 1 .3 M 06/13/2001 Swelling of left leg, vomiting X 2, very fussy, fever 102.5F (ax). Y 06/12/2001 06/12/2001 0 PVT PVT NONE NONE 1
0172146 06/20/2001 HI 1.25 1 .3 M 06/09/2001 Approx. 2 1/2 hours, post vax, pt developed a fever of 40.1C and had a tonic-clonic seizure X 1 minute. After seizure, had 15-20 minutes of limpness/pallor and then became very irritable for 1 hours, then much more consolable, after receiving Tylenol. Y Y 06/08/2001 06/08/2001 0 NONE PVT PVT NONE NONE NONE 1
0172147 06/20/2001 MS 1.0 F 06/13/2001 Localized erythema at injection site; discrete area of erythema at separate site with some swelling on same thigh. U PVT PUB 1
0172148 06/20/2001 AZ 2.0 2 .0 F 06/13/2001 Received 1st Hep-A on 6/7/01. Developed fever to 101F and hives around injection site that same day. Hives spread to other parts of body, still present on 6/12/01. Will recover/become asymptomatic. Y 06/07/2001 06/07/2001 0 NONE PVT PVT Ciloxan oph susp. URI/Conjunctivitis NONE 1
0172149 06/20/2001 CA 38.0 38 F 05/25/2001 Complained of redness, swelling and pain at injection site. Began within 24 hours of injection. Also, complained of cramping and diarrhea with onset in 18 hours, post vax. This continues today (day 2). U 05/23/2001 05/24/2001 1 NONE PUB UNK Allergy to dicloxacillin 1
0172150 06/20/2001 CA 0.5 0 .5 F 06/14/2001 Pt cried for a prolonged period of time, post vax. Also, happened at 4 month exam. Y 05/17/2001 05/17/2001 0 NONE PVT PVT NONE NONE Lactose intolerance Cried for a prolonged period of time~Polio Virus, Inact. (no brand name)~2~0.30~In Patient 1
0172151 06/20/2001 NH 4.0 4 M 06/13/2001 Erythema and swelling on right deltoid area, site of varivax injection, 48 hours ago. Y 06/11/2001 06/13/2001 2 PVT PUB NONE 1
0172152 06/20/2001 FL 67.0 67 M Local arm swelling with fatigue. Y 11/03/2000 11/04/2000 1 MIL MIL NONE NONE NONE 1
0172153 06/20/2001 PA 5.0 5 M 06/12/2001 Large red swollen area around site of injection, 6cm in diameter. Y 06/04/2001 06/06/2001 2 NONE PVT PUB Large red swelling at injection site~DTaP + Hib (no brand name)~4~3.00~In Patient 1
0172154 06/20/2001 OH 76.0 75 F 06/13/2001 Local reaction at left deltoid, 9cm X 9.5cm erythema, induration and pruritus. U 06/11/2001 06/13/2001 2 PVT PVT Prevacid, vitamin C, Lipitor, chondrotin Osteoporosis vaccine given for pre-op knee surgery Allergic to codeine; hyperlipidemia; arthritis; diverticulosis 1
0172155 06/20/2001 FL 17.0 17 F 12/00; mononucleosis. 1/01; viral meningitis with non-epileptic seizures (lost 1 month of school). Seizures tapering to 1 occasionally and very mild. 6/1; After immunizations, seizures are back as in 1/01. Not recovered as of 6/14/01. N 06/13/2001 06/16/2001 3 NONE PVT UNK Tuberculin/right arm/3 previously; Celexa NONE Migraines 1
0172156 06/20/2001 MI 0.25 0 .2 F 06/13/2001 Irritability; increased temperature (37.4C-37.5C Ax); desats. Tylenol given, post vax, and X 2 in the AM to treat. Fever 102F decreased back to 50%. Y 06/10/2001 06/10/2001 0 Temperature 36.9C in PM after RX. PUB UNK BPD on NCP BPD 1
0172157 06/20/2001 TN 27.0 27 M 06/14/2001 Febrile with temperature of 101.1F, localized erythema, edema at injection site, pain and decreased ROM on left arm. Y Y 06/12/2001 06/14/2001 2 NONE PVT OTH Keflex 500mg po at 11:42 on 6/12/01 Laceration NONE 1
0172158 06/20/2001 MA 31.0 31 M 06/15/2001 Site of administration very sore, had chills and arm swollen. Y 06/05/2001 06/07/2001 2 NONE OTH PUB NONE NONE NONE Arm soreness~Influenza (Seasonal) (no brand name)~~0.00~In Patient 1
0172159 06/20/2001 NV 32.0 32 M 06/07/2001 Developed fever the night the shot was received. Pt reports temperature of 102F-103F. Took ASA to reduce fever (2 tablets) X 1. When pt awoke the next AM, he had head congestion, stuffy nose, sinus pressure and right ear "completely plugged". Pt complained of continued head congestion to this day. U 05/07/2001 05/07/2001 0 NONE PUB PVT ASA-daily; sinus OTC meds; GNC dietary supplement "Normal allergy symptoms" Seasonal allergies 1
0172160 06/20/2001 PA 8.0 4 M 06/15/2001 Chickenpox marks on belly, shoulders, arms and itchy. Afebrile. U 10/22/1996 06/14/2001 1696 NONE PVT PVT Albuterol with cromolyn; Vanceril inhaler NONE Asthma 1
0172161 06/20/2001 MI 17.0 17 F 06/14/2001 6/12/01 complained of injection site being sore immediately, post vax. The following AM, 6/13/01, temperature was 101F and complained of a headache, neck and back pain and swollen glands. Arm site ok, no redness or soreness. 6/14/01, all symptoms gone. Y 06/12/2001 06/13/2001 1 PVT PVT NONE NONE 1
0172162 06/20/2001 IN 5.0 5 F 06/12/2001 The pt received 2 injections. Immediately after receiving the 2nd injection (IPV), the pt passed out for about 30 seconds and then regained consciousness. He was pale and slightly blue around the mouth. He was examined at that point, by a physician, who dx'd a vasovagal response. The pt left the clinic much improved and in good spirits. Y 06/12/2001 06/12/2001 0 PVT PVT NONE Left otitis media 1
0172163 06/20/2001 OH 3.0 1 .0 M 06/13/2001 Came to office on 6/10/01, with having "spots" on chest X 5 days. Spread to foot and back. No fever. Y U 06/23/1999 06/05/2001 713 PVT PVT NONE NONE Uterine stroke 1
0172164 06/20/2001 MA 1.08 1 .0 F 06/12/2001 Fever X 1 day, few red dots, blanch with pressure. Y 05/29/2001 06/07/2001 9 NONE PVT PUB NONE Stuffy nose None 1
0172165 06/20/2001 VA 13.0 13 F 06/13/2001 Chest pain, general body fatigue, fever, swelling of tongue (airway remained open) and severe headache. Awaiting follow-up in 3-5 days. ASA-steroid burst. Y U 06/08/2001 06/10/2001 2 PUB PUB Obesity (334 lbs); Tick bite (1 week prior) 1
0172166 06/20/2001 TX 1.0 1 .0 F 06/13/2001 Developed urticarial rash, generalized, within several hours, post vax. Other symptoms were irritability and 1 episode of emesis. Treatment: Benadryl syrup. Y Y 06/11/2001 06/12/2001 1 PVT PVT Benadryl NONE NONE 1
0172167 06/20/2001 IL 0.6 0 .6 F 06/05/2001 Child was awake during night of shots and had temperature (according to mother, but did not take temperature to see how high and may also be teething). Mom gave child Tylenol during the night. Now has a red raised rash on all of body except legs. Exposed to 5th disease, 2 weeks ago. Told mom to call doctor now. No respiratory problems. On 6/6/01, mom called next day and said she called the doctor and he said to give baby Benadryl and mom did this and rash cleared up a lot by the next day. No temperature and was to take baby to doctor if it didn't clear up. Y 06/04/2001 06/05/2001 1 PUB PUB NONE NONE NONE IL01022 1
0172278 06/21/2001 NY 30.0 F 08/08/2001 Information has been received from a physician concerning an approximately 30 year old who was possibly exposed to her 15 year old vaccinated niece who developed chickenpox and was scabbed all over on 5/4/98. It was reported that the 15 year old was vaccinated on 4/15/98. Subsequently in 1998 possible secondary transmission was reported ant the pt died presumably from chickenpox. The physician was not aware if the pt had been in contact with her niece or had any exposure to chickenpox. Additional information has been requested. Follow-up from the physician reported that the pt was taking steroids for an unknown cause. It was reported that her child developed natural chickenpox, that the pt was exposed to her child and subsequently died. The physician did not know the cause of death but she "felt that it was from natural chickenpox and she did not think that this was a complication from the vaccine." The physician did not have any further details because they were not her pts. It was reproted that the pt's niece had no history of chickenpox and was vaccinated with the first dose of varicella vaccine live after exposure to her cousin, the pt's child, who had natural chickenpox. No further info is expected. Y N OTH OTH UNK varicella exposure WAES01052608 1
0172280 06/21/2001 CA 50.0 50 M The pt experienced dizziness, and hard time focusing. This will last for 2-5 minutes 2-3 times a day and 2 days a week. Blacked out yesterday while driving and 2 weeks ago noticed a lump on left side. Had upset stomach X 2 weeks. Something gave him a rash. He states he felt well yesterday morning. At about 08:00, he took his daughter to school and while driving back, his vision went away and lasted about 30 seconds; couldn't see anything. His body felt fine and slowly over 15-20 minutes, his vision came back. He went to work but felt a little dazed the rest of the day. Today, he has epigastric pain. Dx'd as symptoms most likely due to migraine, new onset and epigastric pain due to PUD or gastritis. Also, planar fasciitis discussed and info given and arch supports. Follow-up visit on 11/9/99, has some nasal congestion. I think his episode last week was vertigo and his episode last month was a migraine. On 12/22/99, here for 5 days of congestion, body aches all over and weakness. Also, has a non-productive cough with wheezing and SOB. He has a feverish feeling, sinus congestion and some diarrhea. On exam, he has right basilar crackles. Dx'd with bronchitis and URI and rx'd Erythromycin 250mg qid; Azmacort 4 puffs 1id 1X2. Seen on 6/19/00 and dx'd with HTN; fatigue; lack of sleep; cough; sore throat X 10 days and treated with Atenolol 50mg po. Continue with Thera-flu and fluids. Seen on 5/31/01 with dizziness and headaches; brief blurred vision X 2 years and neck pain. Discussed with pt headache due to tension and stress. On 7/24/01, has slight tender lump on left thorax X months, nodes on left upper extremity and back that he wants excised. Unclear if he wants left thorax lump off. He is concerned if it may be cancer. Dx'd with limpoma and moles. Dermatology referral for mole excision. Seem 8/27/01 with feeling tense, headache and anxiety attach 2 X and went to ER on 8/3/01. Treated with cyclobenzaprine; diazepam 5mg. Added Hytrin 2mg 1 po qhs 60, Serax 10mg 1 po bid. Follow up 07/02/2001: "Dizziness and visual disturbances persist. New onset headaches "behind head" over past 6-7 months...therefore patient has not recovered from adverse event. Patient however, is on full duty status." Y Y U 05/22/1999 05/30/1999 8 Skin biopsy-Neurofibroma, skin of left upper arm; SGOT-28 u/l (inc); SGPT-65 u/l (inc); Cholesterol-308/LDL-207 (high); H. pylori EIA-1.42 (high; Cat Scan-neg MIL MIL Atenolol, Baby ASA, Zantac bid-not helping NONE Allergy to Septra; Hypertension 1
0172281 06/21/2001 VA 0.3 0 .4 M 05/29/2001 Approximately 1-2 hours post vax, the pt cried in great pain for about 1 hour. Then the pt slept through the next morning. He was very lethargic that increased during the day. The pt vomited once, experienced abdominal cramping and pain. The pt was diagnosed with intussusception. Y Y Y 04/30/2001 04/30/2001 0 CT scan of abdomen, lab test - intussusception PVT PVT NONE NONE 1
0172283 06/21/2001 MN 41.0 41 F 06/20/2001 On 6/1/01 the pt experienced severely swollen lymph nodes and a temp of 104 for 5 days. On 6/13/01 blood pressure was 190/100 and remains very high. Blood pressure was normal on the day of vaccines. Y U 05/30/2001 06/01/2001 2 chest x-ray, CBC, blood sugar, thyroid - all normal PVT PVT polio vaccine was also given on 5/30/01 NONE NONE 1
0172284 06/21/2001 ME 1.0 1 .0 M Patient developed a local reaction on 4/16. On 4/23 the patient had a hard lump and bruising at injection site. On 4/26 patient was noted to have a pea-size left inguinal node and a 1 cm slightly tender mass on left thigh which was a hematoma or possible early abscess. Y 04/13/2001 04/16/2001 3 UNK UNK ME01014 1
0172285 06/21/2001 PA 5.5 0 .5 M 06/15/2001 Redness, swelling 3 1/4" X 4" anterio-lateral left thigh. Y Y 06/13/2001 06/14/2001 1 PVT PVT NONE NONE NONE 1
0172286 06/21/2001 ME 1.0 1 .1 M 06/14/2001 23 days, post vax, pt had macro-papular rash, a few vesicles and < 30 lesions. No fever. Mild itching. No signs or symptoms of secondary infection. U 05/21/2001 06/12/2001 22 PVT PUB NONE NONE Allergy to milk and ? soy. ME01030 1
0172287 06/21/2001 IN 1.25 1 .3 M 06/14/2001 Patient developed rash 2-3 days after receiving vaccines. Rash was initially 2-3 raised, red spots which appeared on the legs but had spread to chest, extremities and neck by 6/8/01. Father reported on 6/12/01 that rash was beginning to look like blisters and some were rupturing and scabbing over. On examination of 6/13/01, patient was diagnosed with rule out varicella and impetigo. The left lower leg, chest and arms showed red papules. The patient received varicella vaccine on 2/15/01 and had no known exposure to chicken pox. Y U 05/31/2001 06/02/2001 2 PUB PUB UNK NONE NONE 1
0172288 06/21/2001 HI 1.0 1 .1 F Patient developed mild case of measles with distinct morbilliform rash, cough, coryza and high fever Y 06/05/2001 06/11/2001 6 MIL MIL Tylenol NONE NONE 1
0172289 06/21/2001 NJ U 06/20/2001 Six months after receiving vaccines, the patient reported arthralgia. Additional information has been requested. U OTH MIL 20010146531 1
0172290 06/21/2001 MO 4.0 4 F 06/19/2001 Patient developed a 3.5" x 4" red, warm, firm and tender area over lower left deltoid. The patient was prescribed antibiotics for 7 days. Y Y 06/14/2001 06/16/2001 2 PVT UNK NONE 1
0172291 06/21/2001 ME 1.25 1 .3 M Patient developed a 5 x 3 cm area of redness, warmth and tenderness. Y Y 06/04/2001 06/06/2001 2 NONE PVT UNK NONE ME01029 1
0172292 06/21/2001 ME 38.0 38 F 05/29/2001 Patient developed a 30 x 35 cm area of redness and warmth on left upper arm at site of injection. U 05/25/2001 05/27/2001 2 NONE PVT PVT NONE allergy to penicillin ME01025 1
0172294 06/21/2001 ME 1.08 1 .1 F 04/26/2001 Patient developed chicken pox more than two years post vaccination. Y 06/01/1998 04/23/2001 1057 NONE PVT PUB NONE ME01013 1
0172295 06/21/2001 ME 1.3 1 .4 M Patient developed a 3-4" red, swollen rash on right thigh that was warm to the touch. Y 04/04/2001 04/06/2001 2 NONE PVT UNK NONE NONE ME01015 1
0172296 06/21/2001 ME 83.0 83 M 05/17/2001 Patient developed broken blood vessels and ecchymosis in right arm. U 05/13/2001 05/14/2001 1 CBC PUB OTH pneumonia Allergy to Vasotec and Catapres ME01021 1
0172297 06/21/2001 ME 1.7 1 .7 F 05/25/2001 Patient developed a 3 x 7 cm area of erythema and swelling on left deltoid. Y 05/23/2001 05/24/2001 1 PVT PVT NONE NONE NONE ME01022 1
0172298 06/21/2001 ME 1.25 1 .3 M 05/25/2001 Patient developed a 6 x 6 cm area of redness and warmth to the touch. The patient became fussy but not inconsolable. Y 05/22/2001 05/23/2001 1 PVT PVT NONE NONE NONE ME01024 1
0172299 06/21/2001 ME 1.25 1 .3 F 05/31/2001 Two days post vaccine, the patient developed approximately 10-12 raised, papular, erythematous lesions on back and thighs. Y 05/24/2001 05/26/2001 2 NONE PVT PVT NONE NONE ME01026 1
0172300 06/21/2001 ME 2.25 M Patient developed a 6 x 6 cm localized area of redness and swelling. Y NONE UNK UNK NONE ME01027 1
0172301 06/21/2001 ME 30.0 M 06/08/2001 Patient developed redness and soreness that occurred 1 day after vaccination. This resolved in 2 days. Patient developed numbness in fingers. Three and a half weeks post vaccine, the patient awoke with excruciating pain in right shoulder that did not respond to muscle relaxants or ibuprofen. Y U 05/08/2001 06/02/2001 25 PVT PUB NONE Allergies ME01028 1
0172302 06/21/2001 NJ 2.0 1 .0 F 06/16/2001 Patient developed chicken pox. U 02/08/2000 06/16/2001 494 NONE PVT PVT NONE NONE 1
0172303 06/21/2001 MI 14.0 14 F 06/14/2001 Sixteen hours after vaccine, patient developed shakiness, backache and fever. Before Tylenol she was burning up, and after Tylenol her temperature was 100. She was asymptomatic after 30-35 hours. Y Y 06/12/2001 06/13/2001 1 NONE PVT PVT mild asthma 1
0172304 06/21/2001 ME 9.0 9 M 05/10/2001 Patient developed a 4 x 2" localized reaction on right leg characterized by redness and swelling. Y Y 03/30/2001 04/01/2001 2 PVT PUB NONE NONE NONE ME01016 1
0172305 06/21/2001 ME 4.5 4 M Patient developed an 11.5 x 12 cm baseball sized red raised area. Y Y 03/31/2001 04/02/2001 2 NONE UNK UNK ME01017 1
0172306 06/21/2001 ME 5.0 5 M 05/24/2001 Patient developed a 7.5 cm diameter round rash that was warm to the touch. Y Y 03/27/2001 03/29/2001 2 NONE PVT UNK NONE NONE ME01018 1
0172307 06/21/2001 ME 1.5 1 .5 M 05/25/2001 Patient developed a 3 x 6 cm area of redness and warmth. Y Y 03/13/2001 03/14/2001 1 UNK UNK NONE NONE ME01023 1
0172308 06/21/2001 ME 1.4 1 .4 M Patient's right leg became swollen with a lump and a 3 x 6 cm area of erythema. Y Y 04/05/2001 04/07/2001 2 NONE PVT UNK NONE NONE ME01019 1
0172313 06/22/2001 TN 1.25 1 .3 M 06/15/2001 Information has been received from a foreign legal firm concerning an approx. 15 month old male with a history of croup at 12 months, who on 1/27/93 was vaccinated with his 1st dose of MMRII. Concomitant therapy included Hib conjugate vaccine in the right leg on 1/17/93. In approx. 1/93, the pt experienced autism, with initial symptoms of fever and irritability. At the mother's request, the child had been seen by an ENT surgeon because he had always drooled and was a mouth breather. His hearing was tested in 8/94 and was determined to be normal. The pt was referred to a speech therapist in July, 1994 and had been recently assessed by the therapist. The pt was evaluated by a physician with his mother and 4.5 year old brother, on 10/5/94, for behavior problems and speech delay. It was reported that the pt is the 2nd of 2 children. His father is a photographer and his mother is an ENT nurse. His mother had a normal pregnancy and the pt was born full term, with a birth weight of 8lbs. His motor milestones were normal, although he did not walk until approx. 14 or 15 months of age. During the evaluation, the pt's mother stated she was happy with the pt's development and that her main concern was with the pt's speech. The pt had a good vocabulary but did not put words together and missed the ending of the words. His gross motor function were normal and fine coordination was good. He was described as having poor listening skills, being overactive and agile and having no fear. He was able to concentrate when watching video and television. He attended playgroup 3 days a week and mixed well, but his teacher had to keep him under control because he tended to be quite active. It was reported that during the evaluation, the pt only cooperated in building a tower. He did not sit on the chair, climbed on the table, threw toys everywhere and did not concentrate. The assessment had to be abandoned due to his unacceptable behavior, attended playgroup 3 mornings a week. On 2/19/97, the pt received a booster shot of MMRII in the left leg (lot HC39880). Upon internal review, the pt's autism, fever, and irritability were considered "Other Medical Events". Additional information has been requested. Follow up information states that 2 weeks after injection, he developed a serious thirst.Within 6 months after the injection, approximately 7/93, it was reported that the pt's behaviour deterorated, he started to get constipated.He started vomiting, was not speaking a great deal. Within 9 months the pt's sleeping pattern was poor. He displayed obsessional behavior and started having temper tantrums. It was reported that in 1997, the pt had developed absence seizures. On 02/19/97 the pt received a booster of MMRII. The pt was diagnosed with autism in December 2000. Upon internal review, the pt's autism ans seizure were considered OMIC. Y Y N 01/27/1993 01/28/1993 1 hearing test - normal UNK UNK croup WAES01060307 1
0172317 06/22/2001 PA 34.0 34 M 06/19/2001 A nurse reported that a 34 year old male now 36 years of age, received an injection of Flu Shield '99-'00 formula, in 10/99. Approx. 1 week later, he was dx'd with Guillain-Barre Syndrome. The pt was hospitalized and recovered. No further information was available at the date of this report. This report of a serious, labeled event is being submitted in a 15 day time frame. Y Y 10/01/1999 UNK OTH OTH UNK UNK UNK HQ2168218JUN2001 1
0172318 06/22/2001 PA 6.0 F 06/15/2001 Information has been received from a health professional concerning an approx. 8 year old female who was vaccinated with varicella virus vaccine live on an unknown date. She presented to her doctor's office with a severe looking rash on the inside of her thigh (side unknown) that was thought to be herpes zoster. When the child was examined, chickenpox lesions were found on the upper chest. It was noted that samples were taken to be sent to the CDC. It was noted that there was swelling at the site. The physician felt there was an infection and the child was admitted to the hospital. She was found to have "necrosis from a muscle abscess in her thigh". A drain was put into the leg to help drain pus that resulted from the necrotizing fasciitis. It was noted that the muscle abscess was thought to be a "reaction to the herpes zoster rash". Follow-up information has been received from a physician and a health professional who states this child was previously healthy with no known immunosuppression or on any medication within at least 30 days prior to these events. The pt's mother reported that vesicular lesions began on 5/8/01 on the child's thorax, legs and arms. On 5/13/01, the dermatomal lesions began to develop on the child's left leg. When the child was seen at the physician's office on 5/14/01, the lesions had scabbed over, but the child had a fever of 104F and complained of pain on the left groin. The child had a classic dermatomal zoster band approx. 4 X 6 along the L1-L2 dermatome. There was edema at the site. It was reported that the child "may have developed herpes zoster on the thigh after a possible case of mild breakthrough chickenpox rash". The child was treated with acyclovir. It was noted that during the week of 5/14/01, the child had received a kick to the groin. The child had begun to recover from the herpes zoster, but on 5/18/01, she developed a fever and pain. She was admitted to the hospital on 5/20/01. At the time of admission there was no zoster rash noted on the child's thigh. When the child continued to complain of pain, a groin CT scan was done which revealed a large abscess (14 X 13). The abscess required surgical intervention with an incision, drainage and placement of a Penrose drain. A culture from the drainage showed staphylococcus aureus and the pt was treated with IV oxacillin (manufacturer unknown). The child was discharged from the hospital on 5/24/01. It was suggested that the pt have repeat blood work done in 6 weeks. Recovery status was not reported. Additional information is expected. The follow-up states that it was noted that the rash healed in less than 4 weeks and that the child missed 14 days of school. Additional info is expected. Y Y Y 05/06/2001 IGA and IGM and a vesicular specimen were sent for analysis. All the serologies were negative, however, the PCR of the vesicular specimen was VZV (+) and WTV was identified by PCA analysis. CT of groin-revealed a large abscess; Fever-104F; wound culture-staph aureus OTH OTH NONE NONE WAES01060435 1
0172319 06/22/2001 NC 0 .0 F 06/13/2001 The pt was presented to the ER on 6/11/01. The pt developed erythema multiforme and to be tested to rule out sepsis. The pt was transferred to the hospital. diagnosed with parainfluenzae Y Y 7 Y 05/18/2001 06/11/2001 24 Blood culture - pos, urine culture - pos, CSF culture - pos NP swab - + parainfl. III PVT UNK None NONE 1
0172320 06/22/2001 OR 3.0 3 M 06/15/2001 Swollen left arm. Sent to OHSU per taxi. Soft ice pack wrapped and applied to arm. Given 2 tsp Benadryl 12.5/5 given now (14:35). Y U 06/13/2001 06/14/2001 1 PUB PUB NONE NONE NONE OR200125 1
0172321 06/22/2001 OK 0.5 0 .5 M 06/14/2001 2 hours, post vax, child had decreased activity, would not eat, ran a fever and appeared limp for 2-3 hours. Y 06/12/2001 06/12/2001 0 NONE PUB PUB NONE NONE 1
0172322 06/22/2001 PA 0.3 0 .4 F 06/15/2001 Pt had fever of 101F-102F, listless, lethargic, moaning and hypotonia. Y 02/20/2001 02/20/2001 0 NONE PVT PVT RSV/BOM 2/5/01 1
0172323 06/22/2001 FL 1.3 1 .4 F 06/14/2001 48 hours, post vax, daughter had a runny nose. By 96 hours, post vax, she had unproductive, persistent cough that disturbed sleep. One week, post vax, she was dx'd with ear infections. Y N 06/07/2001 06/09/2001 2 PVT PVT Recently completed 10 days of Suprax NONE Ear infection 1
0172324 06/22/2001 CO 1.6 1 .6 F 06/15/2001 Syncopal episode, paleness and limp. Recovered completely within minutes. O2 was given by nasal cannula for 5-10 minutes. Observed pt for 30 minutes after symptoms. Y 06/13/2001 06/13/2001 0 NONE PVT PVT 1
0172325 06/22/2001 CA 0.2 0 .2 M 05/31/2001 Parent reports temperature of 107F, post vax. Denies other neurological symptoms. Seen today for exam. Temperature 99.4F. Vaccines not given at this site. Y 05/30/2001 05/30/2001 0 NONE PUB UNK NONE NONE NONE CA010063 1
0172326 06/22/2001 WI 52.0 50 M 06/07/2001 Knee pain in both knees approx. 3 months after last shot of series. Pain is an arthritis-like feeling in knees. (Series of 3 shots) 2nd on 5/19/99 and 3rd on 5/16/00. N 04/21/2000 08/01/2000 102 PVT PVT NONE NONE 1
0172328 06/22/2001 IN 1.0 1 .0 F 06/15/2001 Pt began vomiting with a temperature of 100.7F. Pallor, appeared to have abdominal pain and rash developed on 6/15/01 PM; fine, maculo-papular diffuse rash. Pt saw another doctor concerning her abdomen and was treated with Ceftriaxone for possible bacteremia. Y Y 06/13/2001 06/13/2001 0 WBC-19,200; electrolytes; UA-nml; Upper GI-possible bacteremia PVT PVT NONE 1
0172329 06/22/2001 DE 7.4 M 06/18/2001 Pt developed a vesicular papular rash in various stages of evolution, typical of varicella, plus pruritus. No fever and no known infection exposures. This vaccination was given in 1998. Y 06/14/2001 E/A for varicella zoster; acute and convalescent titers-pending PVT PVT NONE NONE NONE 1
0172330 06/22/2001 LA 4.0 1 .0 F 06/12/2001 Y Y 11/20/1997 06/12/2001 1300 Do data provided. PVT PUB TB tine; Cortef; Florinef NONE Congenital adrenal hyperplasia 1
0172331 06/22/2001 MN 27.0 27 M 06/15/2001 Pt c/o rash & raised erythema on L triceps that continued to spread all over body (large erythematous plaquer) No SOB, No respiratory problems. Y 06/14/2001 06/14/2001 0 PUB PUB STD screening NKDA 1
0172332 06/22/2001 NC 1.6 1 .6 F 06/12/2001 Local reaction to immunization DTaP - ? cellulitis R leg 6x8cm 2+ red, warm, indurated. Treatment: Augmentin 400mg/5ml 3cc po bid x 10 days and benadryl 1 tsp q6hrs prn. Y 06/07/2001 06/08/2001 1 NONE PVT PUB Mild upper respiratory infection NONE 1
0172333 06/22/2001 FL 12.0 12 M 06/13/2001 The pt experienced pain, swelling at the injection site and warmth to the touch. Y 06/05/2001 06/07/2001 2 PVT PVT NONE NONE 1
0172334 06/22/2001 TX 11.0 11 F 06/11/2001 Approx. 1 1/2 hours ago from shot (Hep-B) in left deltoid, cleaned with alcohol. Pt developed diffuse pruritic urticarial rash over trunk and extremities. No cough, shortness of breath or edema. Prescribed Benadryl by mouth every 6 hours. Will submit Hep-B antibodies in the future. Y 06/11/2001 06/11/2001 0 NONE MIL MIL NONE NONE 1
0172335 06/22/2001 OR 1.0 1 .0 F 06/12/2001 On 6/1/01, temperature of 103.2F. Tylenol given and it went down to 100F. The next day, it was 102.2F and decreased to 99F with Tylenol. The next day, up again to 102.2F. Per mom, today is down to 99F-97F. "Torso was covered with rash and small red bumps." Y 05/31/2001 06/01/2001 1 PVT OTH NONE 1
0172336 06/22/2001 MI 53.0 53 F 06/11/2001 Local left deltoid edema, erythema and had systemic affect, 2 days, post vax, of larynx. Y Y 06/06/2001 06/06/2001 0 PVT UNK NONE 1
0172337 06/22/2001 19.0 19 F 06/04/2001 New onset complaint of itching. Reported approx. 1 to 2 hours, post initial Hep-B vaccine, with scattered erythematous papules. Was treated with antihistamine. Further vaccine discontinued. Follow-up with primary doctor. U 06/01/2001 06/01/2001 0 NONE UNK UNK NONE 1
0172338 06/22/2001 NM 1.25 1 .3 M 06/15/2001 Large, red, hot and tender site to upper left thigh measuring 3.8cm X 7.6cm at 24 hours. Area appeared "hivish" with irregular border, raised. Follow-up call on 6/15/01, beginning to resolve with cold compresses. Y 06/13/2001 06/13/2001 0 NONE PVT PUB NONE NONE NONE 1
0172339 06/22/2001 MO 2.0 2 .8 M The 6th day, post vax, pt developed fever; 7th day, post vax, rash on face and then trunk; 10th day, post vax, rash on extremities. Saw doctor on 6/15/01. No treatment except Benadryl. Rash started clearing up on 6/17/01. Y 06/04/2001 06/10/2001 6 NONE PUB PUB NONE 1
0172340 06/22/2001 CA 1.0 1 .1 F 06/14/2001 Red vesicles on left thigh. U 05/30/2001 06/12/2001 13 NONE PVT PVT NONE NONE Hearing impaired 1
0172341 06/22/2001 OR 1.08 1 .1 F 06/14/2001 Left thigh with swelling, redness, 3" X 3" reddened, raised area and fever (unknown how high). U 06/13/2001 06/14/2001 1 NONE PUB PUB NONE Allergic rhinitis 1
0172342 06/22/2001 NC 4.0 4 M 06/15/2001 Left leg with erythema 9cm X 14cm around injection sites of DTAP and IPV, puffy and warm to touch. Y Y 06/13/2001 06/15/2001 2 PUB PUB NONE NONE NONE 1
0172343 06/22/2001 CA 1.3 1 .3 M 06/08/2001 Pt got varicella vaccine on 12/20/00 and today on 6/08/01, presents with lesions of varicella on face and chest. Sent pt to lab to draw varicella IgM titers. Informed on the phone that there was a questionable failure of vaccine. N 12/20/2000 06/08/2001 170 Varicella IgM titers PVT PUB NONE NONE NONE 1
0172344 06/22/2001 NJ 1.25 1 .2 M 06/18/2001 Friday night left deltoid was red, swollen the size of a golf ball and warm to the touch. Next day was swollen down to the upper arm. Saw doctor was put on Keflex. Y 06/14/2001 06/15/2001 1 PUB OTH NONE NONE Asthma 1
0172345 06/22/2001 TX 34.0 34 F 06/20/2001 On 6/13/01, severe headache then a high fever with chills and rash from head to toe. Seen by MD and dx'd with viral infection vs allergic reaction. Y Y 06/01/2001 06/13/2001 12 PUB PUB NONE NONE NONE 1
0172346 06/22/2001 MA 1.25 1 .3 F 06/20/2001 Rash on face, chest, back and arms. Small vesicles and fine papules. U 06/08/2001 06/09/2001 1 NONE PVT PVT NONE NONE 1
0172347 06/22/2001 KY 4.0 4 M 06/15/2001 Deltoid of left arm very red with edema over whole upper arm. Y U 06/14/2001 06/14/2001 0 PUB PUB NONE NONE NONE Reaction unevaluable~DTaP (no brand name)~4~3.00~In Patient KY2001045 1
0172348 06/25/2001 AL 0.3 0 .3 M 06/20/2001 A grandmother reported that her 4 month old grandson received his first dose of Prevnar on 5/21/01. On 6/3/01 he died of sudden infant death syndrome. He was seen earlier in the day by the physician and "everything was normal". Y 06/03/2001 N 05/21/2001 06/03/2001 13 UNK PVT OTH UNK UNK UNK HQ2306120JUN2001 1
0172352 06/25/2001 0.08 0 .1 M 06/19/2001 This report is concerning an approx. 6 week old male who in 7/98, was vaccinated with a dose of Hep-B vaccine recombinant (yeast). Concomitant therapy included a dose of Hib conjugate vaccine, a dose of poliovirus vaccine (IPOL) and a dose of diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid. He reportedly, developed injection site reactions characterized by hard lumps, redness and warmth. He later, experienced a "high fever". His mother notified the physician. The pt became irritable and inconsolable. He experienced high pitch screaming for several hours and arching of his back. The pt became chronically constipated, needing help to pass hard, clay-like lumps which often made him bleed. Shortly following his immunizations, he experienced a series of "vague seizure activity". His entire body would twitch and he would seem unresponsive. The physician was notified. He experienced a few more episodes and recovered. It was reported that the pt's experiences of seizures are considered an "Important Medical Event". This was originally reported by the pt's mother. No further information is available. Y U 07/01/1998 OTH OTH UNK WAES01061086 1
0172353 06/25/2001 PA 36.0 34 F 01/19/2001 Long term pain in hips, joint pain and loss of mobility. (2nd Lymerix given on 9/10/99 and 3rd on 10/10/99). Y N 08/10/1999 PVT PVT Oral contraceptive; Pepcid NONE Peptic ulcers 1
0172354 06/25/2001 NJ 53.0 53 F 12/15/2000 Cramping in 1 finger in 8/99, progressed to cramping, muscle weakness, fasiculations and atrophy of both hands and forearms by 11/99 causing progressive disability. Treatment with Doxycycline and occupational therapy, did no improve. Extensive testing resulted in dx in 7/00 of motor neuropathy with nerve conduction block on auto-immune response. IV immunoglobulin therapy initiated on 11/27/00 with unknown results; may have to be continued indefinitely. Y 1 Y N 06/28/1999 08/15/1999 48 EMG/NCV 7/00; Sjogren's also positive 15.6 PVT PVT spironolactone 10 years for alopecia; female replacement hormone 12/98 NONE NONE 1
0172355 06/25/2001 IN 0.5 0 .4 F 06/18/2001 Fever, unresponsive to Tylenol, seizures/infantile spasms. Y 2 Y 05/18/2001 05/18/2001 0 LP/CSF sent to lab. Have not received discharge summary. PVT PVT Reglan; Prilosec; Diflucan Persistent mild ear infection GERD; OM-late 4/01; 5/2 and 4/18 1
0172356 06/25/2001 AZ 79.0 77 F General paralysis, cloudiness of mind, breathing difficulties, bloating, chronic colds, flu, runny nose, phlegm, aches, pains in muscles, excessive diarrhea, nervousness, headaches, fever, anaphylaxis and more, etc. Y Y 7 Y Y N 12/01/1998 electrolyte drop, and more, etc. PVT PVT NONE 1
0172358 06/25/2001 OR 1.0 1 .4 M 06/12/2001 The pt experienced facial swelling hours post vax, the worsening of eczema 24 hours post vax, the swelling of hands, feet 24 hours post vax. Diagnosed with an egg allergy. Y Y Y 06/08/2001 06/08/2001 0 CBC, UA, metabolic panel, all normal PVT PUB Zyrtec, Benadryl NONE chronic eczema 1
0172359 06/25/2001 IL U 06/22/2001 This report described cutaneous leukocytoplastic vasculitis in a vaccinee of unspecified age and gender who received Hep-A vaccine, inactivated (Havrix). Allergies, medical history and concomitant medications were not specified. On an unspecified date, the pt received the 1st dose of Havrix. Two weeks, post vax, he experienced cutaneous leukocytoplastic vasculitis. This report is considered to be "Medically Serious". As of 6/16/01, the outcome of the event was unknown. Additional information has been requested. U OTH OTH 20010148401 1
0172360 06/25/2001 TN 1.5 1 .7 F 06/14/2001 On 6/13/01 patient noted to have a baseball sized knot at site. It was red in color and she had a fever at the site. Patient also had a fever to the touch. The area was very tender to the touch. On 6/14/01, the site was 3.5" by 3" and much better. The patient was treated with Motrin, ice and Benadryl cream. Y 06/12/2001 06/13/2001 1 PVT PUB hydrocortisone cream NONE eczema, constipation 1
0172361 06/25/2001 VA 1.08 1 .1 M 06/21/2001 Patient developed a fever the day after vaccines that measured 103. Tylenol was given, and the temperature dropped to 101. Patient was seen by physician for follow-up on 6/21/01. Y 06/20/2001 06/21/2001 1 PVT PVT 1
0172362 06/25/2001 NJ 0.7 0 .7 M 06/06/2001 Within 1 hour after vaccine administration, the patient had sudden onset of severe vomiting, pallor and lethargy. The patient was clammy. He was observed in the office and received oral hydration for 5 hours. Y Y 06/05/2001 06/05/2001 0 BP 110/40 PVT PVT NONE NONE NONE 1
0172363 06/25/2001 PA 4.0 4 F 06/13/2001 Patient developed redness which started at Prevnar site. She developed erythematous papules on left upper arm, left fingers and face. She was treated with Atarax. Y 06/06/2001 06/07/2001 1 NONE PVT PVT Aveeno anti-itch insect bite right wrist PACs and PVCs 1
0172364 06/25/2001 CA 1.0 1 .0 F 05/25/2001 Patient developed a fever and rash. She was seen in the ER and treated with Calamine. Y Y 04/18/2001 04/28/2001 10 NONE PUB UNK NONE 1
0172365 06/25/2001 MD 55.0 54 F 07/30/2001 Patient developed general joint pain after first dose of LYMErix. On 3/8/00, the patient received her second dose of LYMErix. As of 6/20/01, the patient continued to have general joint pain. Additional information has been requested. The follow-up states that the vaccinee had gastroesophageal reflux disease and hypertension. On 02/04/2000, the vaccinee received her first dose of LYMErix. That day after the vaccine had been administered, she began to experinece eneral joint pain. The reporter stated that the adverse event was of moderate intensity. she was treated with ibuprofen. Follow up states that she had no history of gout, psoriasis, Crohn's disease, or Lyme disease. She had no family history of rheumatoid arthritis or lupus. The joint pain persisted. The vaccinee's joint complaints have not been evaluated by a physician. No swollen or warm joints have been noted on physican examination. No joint fluid was obtained. Erythrocyte sedimentation rate, measured on an unspecified date was within normal limits. Antinuclear antibody titer, measured on an unspecified date was negative. The reporter stated that the LYMErix immunization series was to be completed on the recomendation of the centers for disease control and prevention. The vaccinee was to receive her third injection of LYMErix on her next visit. Outcome of the joint pain was not provided. The follow-up states allerigies and concomitant medications were not specified. The vaccinee had gastroesophageal reflux disease and hypertension. On 02/04/2000, the vaccinee received her first dose of LYMErix. That day, after the vaccine had been administered, she began to experience "general joint pain." The reporter stated that the adverse event was of moderate intensity. She was treated with ibuprofen. 07/26/2001, the vaccinee continued to have "general joint pain." Additional info has been requested. N 02/04/2000 02/04/2000 0 OTH OTH UNK gastroesophageal reflux disease, hypertension 20010148951 1
0172366 06/25/2001 NY 61.0 59 M 02/14/2003 *The subject's medical history included allergy to PCN, tick bite (98), Lyme disease (98), osteoarthritis, hip pain, chronic right knee pain, Baker's cyst of the right knee (98), right-sided neck pain (98), Vertigo (98), tinnitus (98), cluster headaches, "mild" migraine headaches (98), photophobia (98), drooping of the left angle of the mouth (98), diminished hearing (98), diminished vibratory sensation in the toes (98), sternocleidomastoid spasm w/related cervicogenic vertigo (98), possible peripheral vestibular dysfunction (98), "mild" stenosis of the left internal and right mid-common carotid arteries, coronary artery disease, myocardial infarction, dyslipidemia, hypertension, premature atrial contractions, nonspecific intraventricular conduction delay, sinus bradycardia, chest pain, micro-infarct in the left frontal lobe of the brain, and "prior" cocaine dependency. Surgical history included arthroscopic surgery for lateral meniscus tear of right knee, coronary artery bypass grafting (93), and 2 percutaneous transluminal coronary angioplasties w/stent placement (91, 97). Concurrent medications included losartan potassium (Cozaar), losartan potassium/ hydrochlorothiazide (Hyzaar), pravastatin (Pravachol), ofloxacin ophthalmic suspension (Ocuflox), and aspirin. The subject received injections of LYMErix on 4/22/99 and 6/26/99. The subject's attorney alleged that the subject received injections of LYMErix in June and July 99. "Thereafter [he] experienced fatigue, weakness and joint pain in his knees, shoulders and hands. After several courses of medication, including Doxycycline, Biaxin [clarithromycin] and Zithromax [azithromycin] the fatigue and weakness lessened, but the joint pain remained. As such, he has been left to suffer w/what has thus far been incurable and at times debilitating pain which has severely limited... his employment options and opportunities." The following info. was obtained from medical records: The subject was evaluated by a chiropractor on 12/16/99 for "injuries sustained as a result of golfing... The PT's chief complain is of severe pain in the right lower back w/radiation into the right gluteus, upper portion, and moderate to severe pain in the lower lumbar region, right side. Pain quality is sharp w/movement and otherwise is a severe ache. Pain is provoked w/standing or moving. It is decreased w/lying down. The pain is constant." The subject reported that the onset of pain was 12/8/99. The chiropractor's impressions were "Paravertebral myofascitis. Lumbar strain/sprain. Lumbar degenerative disc disease at L5-S1." The subject remained under the care of this chiropractor til at least 2/19/01. During this time he reported right sciatica, soreness btwn his shoulder blades, restricted range of motion in his neck, and right shoulder and right upper back pain. During this time, the chiropractor noted weakness in both quadriceps and the right psoas. Add'l Dx's made by the chiropractor included "Cervical sprain/strain" (2/9/00), "Thoracic sprain/strain (2/19/01), and "Shoulder sprain/strain" (2/19/01). The subject remained under the care of this chiropractor until at least 2/19/01. During this time he reported right sciatica, soreness btwn his shoulder blades, restricted range of motion in his neck, and right shoulder and right upper back pain. During this time, the chiropractor noted weakness in both quadriceps and the right psoas. Add'l Dx's made by the chiropractor included "Cervical sprain/strain" (2/9/00), "Thoracic sprain/strain" (2/19/01), and "Shoulder sprain/strain" (2/19/01). The subject presented to the vaccine provider on 1/17/00 w/complaints of continuing pain from the lower back injury sustained while playing golf several months earlier. The MD noted that the PT had degenerative joint disease, especially in the L5-S1 area of the spine. The subject remained under the care of the vaccine provider until at least 10/29/01. During this time, he did not report joint pain, weakness, or fatigue. The subject reported cool fingers, feet and tibias; back spasms; and apainful, pea-sized mass on his left write. During this time period, the subject reported to the MD that he felt "a little better" and was "even swinging a bat" (4/7/00). The MD prescribed triamcinolone (Aristocort) and hydrocodone/ paracetamol (Vicodin ES). Lab analyses performed on 10/29/01 demonstrated abnormal results. Please see Lab Data section. The MD made Dx's of "DJD [degenerative joint disease]" (10/24/00), "Spinal stenosis" (10/24/00), "? Peripheral neuropathy" (4/17/01), "? Raynaud's" (4/17/01), "Ganglion left wrist" (5/25/01), and "Lumbar stenosis" (10/29/01). The vaccine provider referred the subject to a physical therapist, neurologist, neurosurgeon, orthopedist, acupuncturist, and rheumatologist. The subject was evaluated by a neurosurgeon on 3/20/00 for "back pain and muscle spasms for about 3 weeks' duration." At that time, the subject reported that his back pain had begun after playing golf 3 mts prior. "He rested for about 3.5 wks. It got better, but then he had some muscle spasms when he turned the wrong way. Some of these were very bad. Some pain was under the shoulder blade, others were all over the lower back and the mid-back. They were more like muscle spasms, mostly in the mid-back, bilaterally. This pain did not go down the lower extremities or even to the buttocks. It did not go into the neck area either. However, he felt sometimes pain underneath the shoulder blade. W/movement of the neck or movement of the arm or the head, sometimes he would get spasms in the mid-neck area. It is not actually pain from the neck into the shoulder blade, or pain from the neck into the fingers." On physical exam, the neurosurgeon noted that the subject was "mildly overweight". Neurological exam was normal. The neurosurgeon's opinion was "The Sx's that he describes are not consistent w/lumbar stenosis or lumbar radiculopathy, either by history or by exam. So even though the MRI scan shows evidence of lumbar stenosis, it does not appear to be causing Sx's and signs at the present time... I think the complaints that he has are most likely to be muscular than related to radiculopathy. In summary, I find no evidence of cervical or lumbar radiculopathy or myelopathy for that matter." The neurosurgeon recommended physical therapy, "symptomatic treatment as needed", and advised the subject to avoid straining and weight gain. The subject was evaluated by a physical therapist on 3/27/00 for treatment of a lower back injury sustained as a result of golfing. He indicated that the injury occurred in Nov. 99. At that time, the subject reported that he had arthritis, headaches, HTN, back injury, "orthopedic prob's", and "cardiovascular prob's". The prescription for physical therapy, written by the vax provider, indicated a Dx of "somatic dysfunction - L/S [lumbosacral] areas and DJD". The physical therapist recorded the Dx as "degenerative joint disease" and listed the major clinical findings as "1) Severe spinal and LE [lower extremity] tightness. 2) 2/5 trunk strength. 3) Moderate to severe forward head posture." The subject was evaluated by a neurologist on 4/25/00. He reported "a 4-month history of recurrent transient mid back pain induced by body as well as head or arm movement. Pain is counteracted by maintaining rigid posture. Pain is characterized as sharp, stabbing and cramping lasting from seconds to mins. Sx's were previously incapacitating... Onset of his current complaint occurred 3 wks following bedrest for a low back injury experienced during the course of a gold game." On physical exam, the neurologist noted "Forward head carriage, right shoulder is elevated and both shoulders are protracted and internally rotated; right foot is externally rotated. Muscle atrophy: Bilateral rhomboids and right gluteus maximus. Muscle hypertrophy: Erector spinae at the rhoracolumbar junction. Functional: Restricted range of motion of the neck in extension, bilateral rotation and side bending, right more than left; restricted range of motion of the low back in flexion and extension and bilateral side bending; sigmental vertebral restriction T3-4 and T4-5; straight leg raising limited at 70 deg's 2ndary to hamstring tightness; bilateral pelvis instability; faulty shoulder abduction (activated upper trapezius). Muscle spasm: Bilateral upper trapezius, bilateral levator scalulae, bilateral rhomboid and bilateral pectoralis muscle." On neurologic exam, "Pertinent findings limited to diminished pin sensation below the mid tibia." The neurologist's Dx's were "1) Thoracic pain syndrome 2ndary to segmental vertebral dysfunction. 2) Musculoskeletal dysfunction bilateral shoulder girdles and mid back area. 3) Peripheral neuropathy lower extremities." He recommended acupuncture and trigger point and nerve block. The subject remained under the care of this neurologist until at least 9/30/02. During this time, he reported "band-like pain extending to the lateral rib cage on the right side" that began "following moderate trauma to the right subscapular rib cage"; tingling, numbness, and burning paresthesias of both feet; tingling paresthesia of his hand; proximal muscle fatigue of his lower extremities; "some improvement" in symtomatology subsequent to discontinuation of pravastatin (Pravachol) therapy; easily fatigued; difficulty when climbing stairs or uphill walking or prolonged walking on level ground; and frequent muscle aches of the gastrocnemius area bilaterally. The subject reported that he had received LYMErix in Aug. and Sept. 99. He reported recurrence of mid back and scapular pain "only in association w/vigorous physical activity" (4/12/01). On 9/30/02, he reported "no subjective response" to 4 intravenous immunoglobulin treatments. During this time, the neurologist noted focal tenderness of the right inferior scapular border and adjacent rib cage, trophic changes of the distal lower extremity demonstrating decrease in distal hair growth, diminished cutaneous temperature of the distal extremities, diminished vibratory sensation below the knees bilaterally, diminished proprioception over the toes, diminished pin sensation below the wrist bilaterally, 4/5 exertional strength of the proximal and distal muscle groups of the legs, mild balance instability manifested by increase in body away, decreased ankle deep tendon reflexes, and "difficulty during tendem posture". On 9/30/02, the neurologist noted, "In spite of [the subject's] subjective report of no change in his neurologic status, findings on today's neurologic exam indicate significant improvement in muscle strength and sensory exam." Electromyelography (EMG) and nerve conduction studies and other lab analyses revealed abnormalities. Please see Lab Data section. Add'l Dx's made by the neurologist included "Chronic musculoskeletal dysfunction of the mid back (3/9/01), "New onset peripheral neuropathy, etiology undetermined" (3/9/01), "Gradual progression of peripheral neuropathy, etiology remains undetermined. Primary consideration is post vax injury to the peripheral nervous system" (11/6/01), and "Progressive polyneuropathy subsequent to administration of Lyme vax" (3/4/02). During this time period, the neurologist prescribed gabapentin (Neurontin), nortriptyline, procaine intradermal injection, rofecoxib (Vioxx), hot moist packs, electrical muscle stimulation, combination ultrasound/ interferential therapy, spinal manipulative therapy, and intravenous immunoglobin. The neurologist referred the subject to a rheumatologist. The subject's attorney forwarded the subject's medical records to a rheumatologist. In a letter dated 5/3/02, the rheumatologist discussed "the PT's Sx's complex" including "stabbing" back pain that was "at times incapacitating"; back spasms; "band like restriction around the lateral rib cage"; numbness, tingling, and burning paresthesias of the feet; diminished cutaneous temperature over the distal lower extremities; decreased pin sensation below the midtibial level; diminished proprioception of the toes; diminished pin sensation below the wrist bilaterally; easy fatiguability; and difficulty w/ambulation. The rheumatologist wrote, "I believe that w/in a reasonable degree of medical certainly that the progressive peripheral neuropathy that [the subject] currently suffers from is a result of the admin of the LYMErix vax... Unfortunately, the prognosis for this PT is poor, since his neuropathy has progressed despite extensive physical therapy and a variety of medications. Following the reported onset of peripheral neuropathy, the subject experienced degenerative disc changes, DJD, diffuse theoracic spondylosis, spinal stenosis, shoulder sprain/strain, left atrial enlargement, left ventricular hypertrophy, "mild" mitral and tricuspid regurgitation, hypertriglyceridemia, diverticulosis, possible carpal tunnel syndrome, corneal abrasion, and ganglion cyst on the left wrist. "These events were not reported as adverse events due to vax administration, but were found during the course of review of the subject's medical records. Therefore, they are not listed as adverse events. The most recent info, received on 12/9/02, indicated that the peripheral neuropathy had improved as of 9/30/02. The outcome of the joint pain was not reported.* Y Y N 05/26/1999 12/08/1999 196 Antiotensin Conv. Enzyme, 3/12/01, result 71 U/L, range 8-52; Antinuclear antibody, 3/10/00, result Neg; Antinuclear antibody, 3/12/01, result Hemogenous; Antinuclear antibody, 3/12/01, result 1:40; Antinuclear antibody, 10/29/01, result < 1:40, range < 1:40; Babesia Microti, 10/29/01, result Neg; Erythrocyte Sedimentation Rate, 3/10/00, result 6 mm/hr, range 0-10; Erythrocyte Sedimentation Rate, 3/12/01, result 30 mm/hr, range 0-20; Erythrocyte Sedimentation Rate, 10/29/01, result 10 mm/hr, range 0-20; Folate, 3/12/01, result 32.2 ng/mL, range 3-17; Gamma globulin, 3/12/01, result 1.7 g/dL, range 0.50-1.60; Human Ehrlichia Antibody, 10/29/01, result < 1:64, range < 1:64; RPR (VDRL), 3/12/01, result Non-reactive; Rheumatoid factor, 3/10/00, result < 20.7 IU/mL, range 0.0-20.0; MRI lumbosacral spine, 3/13/00 - "Impression: Degenerative discogenic arthritic changes throughout the lumbosacral intervertebral discs w/the most marked degree of accompanying disc bulging at the L2-L3 and L3-L4 levels. Moderate canal stenosis at the L2-L3 level and mild stenosis at the L3-L4 level are present along w/narrowing of the foramina bilaterally"; MRI thoracic spine, 5/30/00, "Impression: There is diffuse thoracic spondylosis... w/resultant mild flattening of the anterior margin of the cord at T2-3 and T5-6 through T8-9. No focal hernation or significant central spinal stenosis is identified. There are diffuse degenerative disc changes"; Immunofixation, 3/12/01, "Diffuse, polyclonal reactions to all antisera: IgG, IgA, IgM, Kappa and Lambda."; Protein electrophoresis, 3/12/01, "Polyclonal gamma increase."; EMG and nerve conduction studies, 3/20/01, "Conclusion: 1) This study shows no evidence to suggest generalized neuropathy. 2) This study is suggestive of borderline entrapment of the left median nerve at the wrist such as seen in borderline left carpal tunnel syndrome"; Lyme total antibodies, 10/29/01, 0.93 (Neg, <0.80); Lyme IgG Western blot, 10/29/01, "Indeterminate"; 41, 45 kD bands present; Lyme IgM Western blot, 10/29/01, "Indeterminate"; 23 kD band present; Sensory nerve concuction threshold test, 8/30/02: "Results: The data indicates: severe decrease of sensory nerve conduction w/in the C7 distribution on the right in the frequency response range of the A beta, A delta and C fibers, mild decrease of sensory nerve conduction w/in the C8 distribution on the right in the frequency response range of the A beta, A delta and C fibers, mild decrease of sensory nerve conduction w/in the L4 distribution on the left in the frequency response ran ge of the A beta and C fibers, and mild decrease of sensory nerve conduction w/in the S1 distribution on the right in the frequency response range of the C fibers. Normal sensory nerve conduction on the right in the frequency response range of the C fibers. Normal sensory nerve conduction w/in the left C7 and C8 and bilateral C6 nerve distribution. Normal sensory nerve conduction w/in the right L4 nerve distribution. Normal sensory nerve conduction w/in the bilateral L5 nerve distribution. Normal sensory nerve conduction w/in the left S1 nerve distribution. Impression: Abnormal study consistent w/polyneuropathy."; EMG and nerve conduction studies, 9/5/02, "mild sensorimotor dysfunction affecting upper and lower extremities consistene w/mild polyneuropathy."; MRI lumbar spine, 9/15/01: "congenital cental spinal stenosis w/diffuse lumbar spondylosis, a small right paracentral disc herniation at L1-2, and prominent bilateral neural forminal narrowing at L4-5 and L5-S1." MRI cervical spine, 9/16/02: "mild diffuse cervical spondylosis w/a small central disc protrusion at C2-3 and multi-level neural foraminal narrowing at C3-4, C4-5, and C5-6." Somatosensory evoked response study of the upper extremities, 9/25/02: "Normal." PVT OTH Aspirain, Losartan potassium (Cozaar), losartan potassium/ hydrochlorothiazide (Hyzaar), pravastatin (Pravachol), ofloxacin ophthalmic suspension (Ocuflox), and aspirin. UNK Allergy to PCN, Baker's cyst, carotid artery stenosis, chest pain, cluster headache, cocaine dependence, coronary artery bypass graft surgery, coronary artery disease, decreased hearing, drooping mouth, dyslipidemia, frontal lobe infarction, hip pain, HTN, intraventricular conduction defect, knee meniscectomy, knee pain, lyme disease, migraine, myocardial infarction, neck pain, osteoarthritis, percutaneous trasluminal coronary, photophobia, possible cervical vertigo syndrome, permature atrial contraction, sinus bradycardia, spasm of right sternocleidomastoid, tick bite, tinnitus, torn knee cartilate, Vertigo, Vestibular disorder, Vibratory sensation. 20010148121 1
0172367 06/25/2001 NY 44.0 44 M 06/15/2001 Patient developed pain in his right arm and had difficulty lifting his arm. He felt that he got flu symptoms, including muscular pain and weakness. He took Advil. Y 03/21/2001 03/22/2001 1 NONE PUB PUB NONE NONE NONE 1
0172368 06/25/2001 VA 1.5 1 .5 M 06/12/2001 Patient developed localized swelling and redness in left leg measuring 2" by 2.5". Y Y 06/11/2001 06/11/2001 0 PVT PVT Augmentin otitis media GE reflux 1
0172369 06/25/2001 NC 41.0 41 F 06/12/2001 Within 24 hours of receiving vaccine, patient had the onset of a fever of 101-102, sore throat, arm swelling and local erythema. Y 06/08/2001 06/08/2001 0 NONE OTH OTH Prilosec, Norvasc, Lo/Ovral, Desyrel, Orlistat sore throat hypertension 1
0172370 06/25/2001 IL 2.75 2 .8 F 05/02/2001 Patient developed varicella infection starting 4/27/01. Y 05/30/1997 04/27/2001 1428 PVT UNK NONE NONE 1
0172371 06/25/2001 RI 1.0 1 .0 M 06/05/2001 Hives occurred 1/2 hour, post vax. Pt also had blood drawn with latex gloves right after shots. Sites with satellite hives on arms, hands, legs and red face. None on trunk. Received 12.5 mg, IM Benadryl. Y 06/05/2001 06/05/2001 0 PUB PUB NONE NONE 1
0172372 06/25/2001 NC 3.0 3 F 06/18/2001 On 6/13/01, mom reported child, in her opinion, had a reaction to varicella. Headache, swollen glands and went to doctor. Also had fatigue, disturbed sleep and loss of appetite. Treatment occurred on Thursday. Y Y 05/07/2001 05/08/2001 1 Mom reports provider ordered blood tests for mono and strep throat PUB PUB NONE NONE NONE 1
0172373 06/25/2001 CA 1.25 1 .3 F 06/16/2001 Uncontrollable crying for 3 months. Disturbed sleep for 5 months. Falling over sideways, like a drunk person and lethargic as though drugged. Y 07/14/2000 07/14/2000 0 NONE PVT PUB NONE NONE NONE 1
0172374 06/25/2001 IN 8.0 5 F 06/12/2001 Broke out in typical varicella rash on 6/9/01. Mild with fewer than 50 lesions, minimal itching and no fever. Y 06/19/1999 06/09/2001 721 NONE PVT PVT NONE NONE 1
0172477 06/25/2001 PA 0.2 M 07/31/2000 It was reported that a male pt received an Act-Hib and a Tripedia vaccination on 5/18/00. Reportedly, that same day, the pt developed a local reaction of redness and swelling. Further information requested. U 05/18/2000 05/18/2000 0 UNK UNK U2000005880 1
0172478 06/25/2001 CA 2.0 2 .0 M 08/15/2000 It was reported that a 2 year old male pt received a TriHibit (a combination of Act-Hib and Tripedia) and a MMR (Merck) vaccination on 7/11/00 at 11:00. By that evening, the pt developed a lump the size of a tennis ball on his right lateral thigh with an erythema multiform type rash. The pt also developed hives that progressed to bruising and purpura on his chest, back and thighs. Treatment of Benadryl was given. Y U 07/11/2000 07/11/2000 0 PVT PVT NONE NONE U2000006080 1
0172479 06/25/2001 TX 1.3 1 .3 F 08/17/2000 It was reported that a 16 month old female pt received an Act-Hib and Tripedia (combined as TriHibit) vaccination along with an IPOL and a Varivax vaccination on 8/2/00. Reportedly, 4 hours, post vax, the pt became fussy and the injection site was red and warm to the touch. By the next day, the reddened area had increased 1" in diameter (3" X 3" area). Further information requested. U 08/02/2000 08/02/2000 0 UNK UNK U2000006390 1
0172481 06/25/2001 CA 0.2 0 .2 F 02/10/2001 It was reported that a female pt received an Act-Hib and an Acel-Imune vaccination on 5/9/00 and again on 7/20/00. Reportedly, after both vaccinations, the pt developed a large local reaction from knee to hip. No specifics were provided. Further information is being requested. From additional correspondence received on 1/31/01, additional pt, vaccine and responsible physician information is expected for this report. Case is closed. Y 05/09/2000 PVT PVT NONE U2001000750 1
0172482 06/25/2001 MO 1.5 1 .5 M 03/08/2001 From initial report received on 1/8/01, it was reported that an 18 month old male was given TriHibit (a combination of Act-Hib and Tripedia) and IPOL vaccines on 1/5/01. Pt reportedly, experienced "within 24 hours" a 5cm X 8cm red area at the injection site radiating to inner thigh. From additional correspondence received on 2/21/01, additional pt, vaccine, vaccine administration and responsible physician information was provided. U 01/05/2001 PVT PVT Extendryl NONE NONE U2001002760 1
0172483 06/25/2001 1.25 1 .3 F 03/08/2001 It was reported that a female pt received a TriHibit (combination of Tripedia and Act-Hib), Prevnar and IPOL vaccinations on 1/24/01. Reportedly, that same day, the pt developed a local reaction of redness and swelling. Further information is requested. Insufficient reporter information was provided, several attempts have been made to contact the reporter. As of 3/7/01, no further information has been received for this case. This case is closed. U 01/24/2001 01/24/2001 0 UNK UNK U2001003990 1
0172484 06/25/2001 WA 0.15 0 .2 M 03/12/2001 Two hours post vax, the pt developed a large swollen, red, hard area at the injection site engaged whole leg, unconsolable crying for seven hours. Resolved in 48 hours. Seen in physicians office. From follow-up #1 correspondence received on 1-MAY-2001, the correct vaccination and adverse event onset dates (10-Nov-2000) as well as additional patient, vaccine and the reporter's phone number where provided. -TS 23-Apr-2001. This case is closed. Y Y 11/01/2000 11/01/2000 0 UNK UNK U2001005090 1
0172375 06/26/2001 LA 0.2 0 .2 F 06/14/2001 Mother did not report any adverse events of anything out of the ordinary. She states that she "went to check on baby, the next morning and found baby dead in her bed". Also, stated baby was active and acted in usual manner, at bedtime, the night before. Autopsy gives cause of death as pulmonary and brain congestion/edema. Death certificate states cause of death as multiple infections (bacterial and viral) in a low resistant anemic baby. Y 06/12/2001 N 06/11/2001 06/12/2001 1 UNK PUB PUB UNK NONE NONE LA010602 1
0172381 06/26/2001 OH 10.0 10 F 06/21/2001 Information has been received from a physician concerning a 10 year old female who on 6/12/01 was vaccinated with Hep-B vaccine recombinant (yeast) (lot 638720/0257L). On 6/12/01, about 4 hours later, the pt experienced a fever of 103.5F, headache, difficulty breathing and swallowing, dizziness and a stomach ache. She was taken by EMS to the ER, treated with oxygen and an unknown steroid. Subsequently, she was released. Upon internal review, the pt's experience was considered an "Other Medical Event". Additional information has been requested. F/U additional info is not expected. This report no longer meets criteria for expedited submission to the FDA because it has been determined that the pt's experience is an expected event. Y Y 06/12/2001 06/12/2001 0 Body temperature on 6/12/01-103.5F UNK UNK UNK UNK WAES01061314 1
0172388 06/26/2001 WA 0.4 0 .4 M 04/27/2001 Per telephone call from the child's mother; on 1/8/01 the pt was seen by MD and received OPV, DTAP, Hib and Hep-B. Mother called the health dept "a few days later concerned that #3 Hep-B had been given before 6 months of age. Was advised that it would need to be repeated after a 2 month interval. Does not recall who she spoke with. On 1/31/01, the pt was seen by MD for a fine rash with fever and was told it was viral. On 2/1/01, the pt had a very brief period where eyes rolled back and child was unresponsive. On 2/2/01, he had a recurrance of the same and was seen by MD. On 2/3/01, he had a recurrance of the same followed by an hour later by a grand mal seizure. Called 911 and was taken to the hospital ER and was admitted to the hospital for 3 days; 2/3/01 through 2/6/01. He had 2 more grand mal seizures while in ER. Had a fine red rash all over his body and a temperature of 100.3F (ear). He was started on Phenobarbital in the hospital which the mother elected to discontinue after child's discharge from the hospital. On 2/28/01, he had 3 more grand mal seizures and was seen at ER; he had a rash then too. Has had no further seizures since restarting on Phenobarbital on 2/28/01. Has been well except for minor URI, which resolved without incident. Y 3 Y 01/08/2001 02/01/2001 24 2/3/01 Series of blood work; Spinal Tap and EEG on 2/5/01-showed a couple of abnormal spikes; MRI on 3/2/01-neg; stool culture-neg PVT UNK NONE NONE None WA011750 1
0172389 06/26/2001 WA 65.0 M 01/22/2001 2 days, post vax, became ill with general malaise and short of breath. Called 911 and was hospitalized for 9 days. (Has not returned phone calls. Unable to get additional information). TX: Antibiotic and IV. Dx'd with pneumonia. Y Y 9 Y 01/11/2001 CXR, blood culture, metabolic panel, sed rate, respiratory culture, UA screen, theophylline level, gram stain PUB UNK Atrovent, Albuterol, Cardura, Pulmocort, Theophylline UNK Asthma, BHP WA011749 1
0172390 06/26/2001 LA 0.2 0 .2 M 06/18/2001 Fever and vomiting about 12 hours, post vax. Vomiting persistent and was hospitalized on 6/15/01. Antibiotics were started. Y 3 Y 06/14/2001 06/14/2001 0 Had blood work; CXR-all WNL except for reflux. PUB UNK NONE NONE LA010603 1
0172391 06/26/2001 PA 69.0 68 F 05/14/2001 Two weeks following immunizations with flu vaccine developed cough, coryza, weakness over the course of week developed dysarthia, dysphagia with cranial nerve paresis on exam. Diagnosed with ALS. According to 213289, 60 day follow up, patient died 03/20/2002 from ALS, unassociated with flu vaccine. Follow up on 09/18/2001: "The patients right arm was prepped and draped in a sterile fashion. 1% Xylocaine was employed for local anesthesia. A hand injection of contrast through a peripheral angiocath provided opacification of the deep veins of the right arm. The right basilic vein was accessed under fluoroscopic guidance with a micropuncture set. A cook PICC catheter was then trimmed to a length of 36cm and advanced through a peel-away sheath into the SVC. A hand injection of contrast through the catheter reveals the tip in the superior vena cava. The catheter was flushed and sutured in place. The catheter was then heparinized with 400 units Heparin and the patient was returned to the post-operative lounge in stable condition. " Y 03/20/2002 Y N 10/06/2000 10/20/2000 14 MRI - neg, Lyme - neg, EMG w/tensilon test - neg PUB UNK NONE NONE PA0147 1
0172392 06/26/2001 NY 0.08 0 .1 M 06/19/2001 Fussy, cranky several hours, post vax. Dad is ill with sore throat. Pt is eating well. No fever, vomiting or diarrhea. Seen back in office on 6/14/01, because crankiness persisted and increased. Admitted for septic work-up because baby was inconsolable. Septic work-up was negative. Treated 2 days with IV antibiotics then discharged. Y 2 Y 06/11/2001 06/11/2001 0 BC; UC; CSF cultures-all neg PVT PVT NONE NONE Right undescended testis; systolic heart murmur 1
0172393 06/26/2001 MS 54.0 54 M 06/15/2001 About 5/16/01, developed low-grade fever. On 5/17/01 had dyspnea with mild exertion which persisted > 1 week. Diagnosed with hypomagnesemia and arrhythmias Y Y 1 Y 05/14/2001 05/16/2001 2 Chem profile LDH-increased at 276; ECG-nml; CBC-nml; magnesium-low PVT PVT NONE NONE MS01026 1
0172394 06/26/2001 DE 0.3 0 .4 M 06/21/2001 Developmental achievement normal until after 4 month vaccines. Baby had DTAP, HEP-B and IPV at 2 months, at another facility. Child now dx'd with encephalopathy and global developmental delay. Y N 01/24/2000 04/06/2000 73 MRI Brain-cortical atrophy, frontal and temporal lobes 5/8/00; Delayed demyelination-white matter in frontal and occipital regions. PVT PVT NONE NONE 1
0172395 06/26/2001 PA 1.4 1 .5 M 05/18/2001 Mom noticed rash to legs on 2/20/01, Tuesday evening. By Wednesday, noticed the rash was worse with intermittent hives. Took child to ER and was treated with Benadryl. ER doctor told mom not to get Prevnar again. Y 02/20/2001 02/20/2001 0 PUB PUB NONE NONE PA0140 1
0172396 06/26/2001 KS 0.4 0 .5 F 06/14/2001 On 6/12/01, child received the below mentioned immunizations at approx. 14:00. Was given several doses of cherry flavored Tylenol (which was not given before). On 6/13/01, the grandma noticed red non-raised rash on neck, chest and legs. Grandma took child to doctor on 6/13/01. No treatment given. Doctor unsure if it was vaccine related. On 6/14/01, rash gone. Y Y 06/12/2001 06/13/2001 1 NONE PUB PUB Cherry flavored Tylenol NONE UNK KS200122 1
0172397 06/26/2001 KS 0.25 0 .2 M When bandaids removed from shots, the next day, mother noticed bumpy round area to skin and right leg. Mother found areas gradually up on both arms and legs, rough and painful areas of skin, not on trunk. Continues to be present. Y 03/05/2001 03/06/2001 1 NONE PUB PUB NONE NONE NONE KS200113 1
0172398 06/26/2001 KY 1.0 1 .0 F 06/18/2001 Started fever on Wednesday, 6/12/01 at night. Fever of 103.5F, was the highest. No appetite and fussy. Was seen in doctor's office on 6/18/01. Y Y 06/12/2001 06/12/2001 0 PUB OTH NONE NONE KY2001046 1
0172399 06/26/2001 NY 1.5 1 .5 F 06/22/2001 Redness and swelling at site of immunizations; 3cm X 5cm diameter of erythema and 2cm X 3cm diameter of induration. Y U 06/20/2001 06/21/2001 1 PVT PVT NONE NONE 1
0172400 06/26/2001 CA 2.0 2 .4 M 06/14/2001 Upper right thigh, reddened and swollen approx. 3cm-5cm area around site; warm. Pt complaining of pain to touch and limps. Y Y 06/12/2001 06/14/2001 2 PVT PUB NONE NONE 1
0172401 06/26/2001 NC 0.2 0 .2 F 06/16/2001 Red, raised, blanching, blotchy lesions on head, torso, upper and lower extremities. Afebrile; stable vital signs. Responded to Benadryl but recurrent over about 1 week period. Y Y 05/30/2001 06/07/2001 8 NONE PVT PVT NONE NONE NONE 1
0172402 06/26/2001 WI 8.0 8 M 06/16/2001 Leg stiffness in left leg and irritability, no fever. Y Y 06/15/2001 06/15/2001 0 PVT PVT NONE NONE Developmental delay; hypotonia; Microcephaly (unknown etiology) 1
0172403 06/26/2001 CA 3.0 3 F 06/04/2001 Mother called clinic after 5 hours, post vax. Mother said child's face has some moderate rashes and was red all over face. Mother said no temperature and no other symptoms or reactions. U 06/04/2001 06/04/2001 0 NONE PUB PUB NONE NONE CA010064 1
0172404 06/26/2001 GA 4.0 4 F 05/25/2001 Pt's mother placed phone call to clinic on 4/26/01. States after shots given on 4/24/01, pt would not walk due to discomfort in left leg. States pt would cry. Reports knot on this leg at site. Y 04/24/2001 04/24/2001 0 NONE PUB PUB NONE NONE NONE 1
0172405 06/26/2001 GA 8.0 8 M 06/21/2001 Small area of induration and erythema, tender to palpation. Y 06/11/2001 06/11/2001 0 NONE PVT PVT Ritalin; Singulair; Flovent Inhaler; Proventil Inhaler; Cefzil Otitis Media Asthma; ADHD; Allergy to PCN 1
0172406 06/26/2001 NC 1.75 1 .8 F 06/21/2001 Fever of 102F, disoriented, falling down, weakness. U 06/20/2001 06/20/2001 0 NONE PVT OTH Amoxil, Tylenol Dx'd on 6/11/01 with acute sinusitis 1
0172407 06/26/2001 MS 1.08 1 .2 M 06/12/2001 On 6/7/01, pt awoke with a rash at approx. 07:00AM. Red, raised wheals on trunk and between legs. No elevated temperature. On 6/8/01, rash mostly resolved according to mother; no fever per phone call. Y Y 06/06/2001 06/07/2001 1 PUB PUB Tylenol-2 doses on 6/6/01 NONE NONE MS01027 1
0172408 06/26/2001 SC 0.75 0 .8 M 06/20/2001 Crying, paleness, weak, dizziness and somnolent. Symptoms occurred 30 minutes to 1 hour, post vax. Pt was examined by a doctor a 12:20 and advised to observe closely. Y Y 06/19/2001 06/19/2001 0 PVT PUB NONE 1
0172409 06/26/2001 GA 0.3 0 .4 M 06/13/2001 Mom reported 1 episode of pallor, decreased responsiveness and extreme lethargy. Y 04/05/2001 04/05/2001 0 NONE PVT PVT NONE NONE Innocent flow related heart murmur 1
0172410 06/26/2001 MO 1.0 1 .1 F 06/14/2001 Seizure Y Y 05/03/2001 05/12/2001 9 UA-unremarkable PVT PVT NONE NONE MO2001034 1
0172411 06/26/2001 IL 2.0 2 .3 M 06/18/2001 Post vax, pt had scattered hives, crying throughout. Oral Benadryl was given, no respiratory symptoms. Looks fine and is resolving and playing. Pt went home with family. Y 06/05/2001 06/05/2001 0 NONE PVT PVT NONE NONE NONE 1
0172412 06/26/2001 CA 1.6 1 .6 M 05/09/2001 Red, swollen and painful left upper thigh with fever. Local reaction of cellulitis. Treated with antibiotic therapy, Keflex suspension 1 tsp 3 X per day X 10 days. Y Y 05/07/2001 05/08/2001 1 NONE PUB PUB NONE NONE CA010070 1
0172413 06/26/2001 PA 3.0 3 F 04/21/2001 Per mom, "after receiving immunizations, started to walk away. She was really pale, like she was going to faint, then she vomited. The nurses had her lay down and they took her BP. She hadn't taken anything that morning and I did give her a dose of Advil before coming. She was fine the rest of the day and night. The next morning at 08:20 AM, she woke up with a blood curdling scream. My husband and I ran into the room. She tried to stand up but said she couldn't move her legs. Her temperature was 102F. Her legs were "limp". We called our doctor, who said to give her Advil and take her to the ER. We did but by the time we got there, she was fine. Her right arm was very swollen, warm to touch and slightly red. The limpness lasted 45 minutes approx. The temperature lasted 24 hours from 101F-102F. Doctor said it could be the shot." Mom states that in 11/00, daughter was dx'd with urinary tract infection and has been on Sulfa drug since then. On 4/16/01, doctor tests for UTI finally were normal. Y Y 04/20/2001 04/21/2001 1 NONE PUB PUB Sulfa UTI-4/16/01 tested normal PA0139 1
0172414 06/26/2001 WA 1.5 1 .5 F 06/18/2001 Swelling, redness, large lump to right thigh treated with ice, massage, elevation, Keflex, ibuprofen prn, Benadryl every 6 hours and Prednisolone X 5 days. Y Y 06/14/2001 06/14/2001 0 PVT PUB NONE NONE WA011767 1
0172415 06/26/2001 WA 0.75 0 .8 M 05/02/2001 Redness, swelling and hot. Pt given Keflex X 4 days. Y Y 04/30/2001 04/30/2001 0 OTH PUB NONE NONE WA011763 1
0172416 06/26/2001 WA 1.0 1 .1 M 05/08/2001 Mom called on 5/3/01 with report of left upper arm reddened and swollen (2" in size) where Prevnar had been given on 4/30/01. Y 04/30/2001 05/02/2001 2 PVT OTH Cefzil since 4/25/01 Resolving otitis media NONE WA011762 1
0172417 06/26/2001 WA 2.0 2 .1 M 05/02/2001 4/27/01, here at clinic with right leg pain and small mass 1.5" X 2.25" and warm to touch. Also swollen and has a fever of 101F. Y Y 04/25/2001 04/26/2001 1 NONE PVT PUB NONE NONE NONE WA011760 1
0172418 06/26/2001 WA 0.3 0 .4 M 05/07/2001 On 5/3/01, pt had fever and diarrhea. Y Y 04/20/2001 05/01/2001 11 PVT PUB Zantac NONE Reaction unevaluable~Vaccine not specified (no brand name)~~0.20~In Patient WA011759 1
0172419 06/26/2001 WA 2.0 2 .1 M Localized erythema/firmness at injection site (2cm-4cm in diameter). U 04/30/2001 05/01/2001 1 OTH UNK NONE NONE NONE WA011748 1
0172420 06/26/2001 CA 1.0 1 .0 M 06/13/2001 Mild rash and slight fever of 100F. U 06/11/2001 06/13/2001 2 PUB PUB NONE CA010068 1
0172421 06/26/2001 CA 1.4 1 .4 F 05/23/2001 Left thigh swelling, induration, red; also vomited multiple times. U 05/08/2001 05/09/2001 1 NONE PUB PUB NONE CA010067 1
0172422 06/26/2001 NY 4.0 54 M 06/20/2001 Complaining of left arm swollen from deltoid area down to elbow, 2 days, post vax. Pt seen in office on 5/5/01. Y Y 05/03/2001 05/04/2001 1 PVT UNK NONE NONE 1
0172423 06/26/2001 PA 2.0 2 .5 F Red, warm to touch, tender, fever, fluctuance face 4cm X 3cm. Treatment: Augmentin suspension 250mg/tsp 2; cold compresses. Has follow-up appt. U 06/18/2001 06/19/2001 1 PVT UNK 1
0172424 06/26/2001 MI 38.0 38 F 06/19/2001 Post vax, within 2 hours, pt started to have tenderness at site. She applied heat to arm and by 6/18/01, arm at site, was swollen to baseball size, red, warm and complaining of tingling and numbness to arm. Instructed to see doctor. Pt has no temperature. Y Y 06/15/2001 06/15/2001 0 NONE PUB PUB NONE Codeine allergy 1
0172425 06/26/2001 IL 1.25 1 .3 M 06/14/2001 Mother states child had red blotchy rash around site of DTAP the morning after injection. By that afternoon, rash had spread to back of neck, left chest and both feet. Feet appear swollen. No treatment at time of phone call but MD notified. On 6/14/01, swelling down and rash subsiding. Y 06/12/2001 06/13/2001 1 NONE PUB PUB NONE NONE NONE IL01023 1
0172426 06/26/2001 LA 1.6 1 .6 M 06/07/2001 Tired, cranky 24 hours, post vax. No fever with Tylenol as instructed. Local reaction on left leg, 48 hours, post vax, with edema, redness and hard area at site. Y Y 06/05/2001 06/07/2001 2 PUB PUB NONE NONE NONE LA010604 1
0172427 06/26/2001 CA 0.75 0 .7 M 06/18/2001 2 days, post vax, in left thigh, pt developed 8, 1mm X 1mm bright red blanching papules, surrounded by white halo (1/2cm) 7 scattered over left thigh and 1 on calf. Y 06/12/2001 06/14/2001 2 OTH OTH NONE NONE NONE 1
0172428 06/26/2001 MO 0.6 0 .6 M 06/08/2001 Post vax, pt began running a low-grade temperature. Mother gave Tylenol after immunizations. Pt ran a fever then during the day of 6/7/01 even using Tylenol alternating with Motrin. At 17:30 on 6/7/01 or 24 hours, post vax, pt spiked a fever of 105F. Family physician contacted. Continued Tylenol alternating with Motrin and cool baths. Child cried for 24 hours. This date of 6/8/01, still has a low-grade temperature but no further crying. Y 06/06/2001 06/06/2001 0 NONE PUB PUB NONE MO2001032 1
0172429 06/26/2001 MO 12.0 12 F 06/14/2001 Onset on nausea, stomach cramps which began approx. 4 hours, post vax, and continued into following day. Y 06/13/2001 06/13/2001 0 NONE PUB PUB NONE NONE MO2001033 1
0172430 06/26/2001 CA 1.4 17 F 06/11/2001 Day 8, became very fatigued, swollen neck glands and becoming worse today with complaint of headache. Tylenol prn since 6/8/01; refer to PMD. U 05/31/2001 06/08/2001 8 NONE PUB PUB NONE NONE Allergy to Penicillin and "environmental things". ~Measles + Mumps + Rubella (no brand name)~~0.00~In Sibling CA010071 1
0172431 06/26/2001 CA 8.0 8 F 06/04/2001 3cm indurated erythema with pain at injection site. Seen at doctor visit, 10 days later. Y Y 05/23/2001 05/24/2001 1 PUB PUB NONE CA010069 1
0172432 06/26/2001 CA 18.0 18 M 06/05/2001 Client was found by a PHN outside the clinic beside his truck on the ground with emesis beside him. On assessment, found a lump on the back of his head about the size of a quarter with a small scrape on his left elbow. Able to move all extremities with full ROM. Pt is awake, able to tell his name but disoriented, unable to tell where he is and what happened. He's pale, cold and clammy and diaphoretic. Assisted back into the clinic and walked without difficulty. Ice pack applied over the back of his head. Supervisor called paramedics and notified mother. Still complained of a severe headache until paramedics came. Y Y 06/05/2001 06/05/2001 0 BP 142/80; P-92 PUB PUB NONE Previous head injury in 8/00 and was seen by a neurologist for 3 months. CA010065 1
0172433 06/26/2001 PA 5.0 5 F 05/23/2001 On 5/23/01, mother called office and said that child had hives on upper body and itching. No SOB. Recommended she call MD if SOB or call 911. Benadryl 1 tsp given at home. Seem MD at 13:00 and more Benadryl given. MD thought it was from the MMR. Y Y 05/23/2001 05/23/2001 0 NONE PUB PUB NONE NONE NONE PA0141 1
0172434 06/26/2001 WA 1.75 1 .6 M 06/19/2001 Diffuse truncal macular rash. No SOB. Fever of 101F. Y 06/11/2001 06/15/2001 4 NONE PVT PUB NONE NONE WA011766 1
0172435 06/26/2001 WA 22.0 22 M 05/14/2001 Rash on legs, groin, back and arms with pruritus. Onset 6-8 hours, post vax, lasting about 72 hours. Treated with Benadryl. Y 05/08/2001 05/08/2001 0 OTH PVT NONE NONE WA011765 1
0172436 06/26/2001 WA 4.0 4 F 05/07/2001 Localized, itchy rash on both arms at the injection sites. Lanacaine prn for relief of itching. Y 05/04/2001 05/05/2001 1 PUB PVT NONE NONE NONE WA011764 1
0172437 06/26/2001 WA 3.0 3 M 05/09/2001 PCP called to report on child seen in ER, taken by parents on 5/2/01 with a rash on body and erythema, post vax, on 4/28/01. ER ordered Benadryl; 0.2ml Epi and Aveeno bath. Given rapid strep A screening on 5/2/01 and it was positive for group A strep, per PCP. PCP feels rash not related to vaccines. Y Y 04/28/2001 05/02/2001 4 rapid strep A-positive PUB UNK WA011761 1
0172438 06/26/2001 WA 63.0 63 M 05/07/2001 Pain in finger joints and ankles. Given anti-inflammatory drugs. Y N 04/16/2001 04/17/2001 1 PUB PVT PPD/152AA/LFA WA011758 1
0172439 06/26/2001 WA 19.0 19 F 04/05/2001 Was seen on 4/4/01 for PE. She had continuation of symptoms. The ARNP decided it may be related to Hep-B received on 4/3/01. She complained of severe headache right after getting vaccine and it increased. Complaining of nausea, shaky, swelling of throat and tongue which hurt and tired. Lasted 32 hours and went away. Treated with Advil. Feels fine today, 4/5/01. Y 04/03/2001 04/03/2001 0 NONE PUB PUB PPD/Connaught/C0152AA/LFA/0 previously NONE WA011756 1
0172440 06/26/2001 WA 15.0 15 F 03/20/2001 Onset, 1 hours, post vax. Chief complaints, headache, dizziness, body aches, sore arms, red eyes and slept most of the day of immunization; did not go to school on 3/20/01. Mother had to feed because arms hurt. Gave Tylenol X 1, ice to arms. Y 03/19/2001 03/19/2001 0 PUB PUB WA011753 1
0172441 06/26/2001 WA 50.0 50 F 03/09/2001 Received MMR on 2/22/01, blood test (-) for measles antibodies. Works with children having a measles outbreak. On 3/3/01, she developed joint pain with left arm pain. On 3/6/01, had swollen axillary lymph nodes and redness at site of injection. Swollen and tender left breast. Seen by doctor on 3/8/01. On 3/9/01, arm is some better this AM. Treated with Advil and Chlor-Trimeton and ice to breast and arm. Y N 02/22/2001 03/08/2001 14 CBC PUB PUB NONE NONE WA011752 1
0172442 06/26/2001 WA 1.8 M 05/09/2001 6cm X 9cm indurated area with warmth and erythema and pain to touch. U PVT UNK NONE NONE WA011747 1
0172443 06/26/2001 AK 51.0 51 F 06/18/2001 Pt states she received Hep-B #2 on 6/14/01 and woke early AM of 6/15/01 with itching, red raised rash to entire body (hives). OTC Benadryl gave no relief. Saw PMD for meds. No reported respiratory difficulty. Y Y 06/14/2001 06/15/2001 1 NONE MIL MIL Lisinopril, Biaxin, Premarin, Albuterol, Serevent Asthma, URI (mild) Allergies to Mangos, grasses, mosquitoes causes large local reaction. 1
0172444 06/26/2001 AK 29.0 29 M 06/18/2001 Pt reported to clinic on 5/31/01 to start deployment immunizations. He was given TD, Hep-B and Typhoid on 5/31/01. Returned on 6/4/01 for Hep-A and later on that day, developed a fever of 102F-104F, headache, nausea, muscle aches, sore arm at injection site of right deltoid. Saw PMD, labs done and PMD dx'd a reaction to TD. Y Y 05/31/2001 06/04/2001 4 CBC at PMD's office reported WNL MIL MIL NONE NONE NONE 1
0172445 06/26/2001 CA 4.0 4 F Right upper arm swelling, redness, "itchy", slightly warm. No induration or pain. Advised cold compress and Benadryl Children's Liquid 1 tsp for itching. Y 04/30/2001 04/30/2001 0 NONE PUB PUB NONE NONE CA010066 1
0172446 06/26/2001 PA 5.0 1 .1 U Breakthrough varicella 2/8/01 with complication of cellulitis with (bacterial super infection). Y Y 12/13/1996 02/08/2001 1518 NONE PVT PUB NONE NONE PA0148 1
0172447 06/26/2001 PA 15.0 15 F 05/24/2001 Pt received MMR on 1/18/01. Pt asked about pregnancy but denied. On 5/23/01, Pt's mom called to state pt was pregnant then but denied it. U 01/18/2001 01/18/2001 0 PUB PUB NONE PA0146 1
0172448 06/26/2001 PA 1.2 1 .2 M 05/29/2001 Rash beginning on 5/25/01 on body, spread to face; fever; coryza prior to rash. Seen in ER on 5/26/01 about 08:00. Titers drawn for Rubella. Doctor feels he felt post-auricular lymphadenopathy. Tylenol prescribed for fever. Y U 05/16/2001 05/25/2001 9 Rubella IgG Titer on 5/26/01-0.8 PVT OTH UNK UNK UNK PA0145 1
0172449 06/26/2001 PA 12.0 12 M 05/29/2001 Next morning, post vax, had congested cough. Gave Robitussin. Went to doctor on 4/10/01 and was given Endol for sinus infection and 2 weeks later, no better and saw another doctor who gave him antibiotic and cough syrup for viral infection. Lungs remained clear. Continued to have cough. Y N 03/28/2001 03/29/2001 1 PUB UNK NONE NONE NONE PA0144 1
0172450 06/26/2001 PA 52.0 52 M 05/15/2001 Onset of chills within 24 hours, post vax. Pt then noticed swelling and redness at site. 9cm X 6cm induration surrounding injection site with patches of erythema distally and tender but no adenopathy. Started on Keflex 500mg, until completed. Y U 05/11/2001 05/12/2001 1 NONE PVT PVT Tenormin, Lamisil NONE HTN, allergic rhinitis, smoker, snuff, onychomycosis PA0143 1
0172451 06/26/2001 PA 18.0 18 F 05/16/2001 Pt had MMR vaccine for school on 5/7/01. On 5/16/01, presented to office with macular papular and itchy rash of chest and abdomen. Y U 05/07/2001 05/14/2001 7 PUB PUB Zoloft NONE PA0142 1
0172452 06/26/2001 PA 3.0 3 F 05/02/2001 Cellulitis treated with Keflex X 7 days. U 04/30/2001 05/01/2001 1 NONE PUB PUB NONE NONE PA0138 1
0172453 06/26/2001 KS 16.0 16 F 06/01/2001 About 10 minutes, post vax, both arms were tingling, both hands swelled and turned blue. No Rx done. By the time the school nurse saw her, the physical symptoms were gone. Y 09/27/2000 09/27/2000 0 NONE PUB PUB NONE NONE KS200121 1
0172454 06/26/2001 KS 16.0 16 F 06/01/2001 About 1 hours, post vax, both arms and legs were stiff. Felt like they were falling asleep. Nauseated, which lasted 5-6 hours. Went to bed and went to sleep. Was OK the next AM. Y 11/06/2000 11/06/2000 0 NONE PUB PUB NONE KS200119 1
0172455 06/26/2001 KS 9.0 9 M 05/29/2001 Mom states child received Hep-B #1 injection on 5/24/01. On 5/25/01, child awoke in the morning with dizziness and paleness which continued for 24 hours. He vomited 3-4 times. On 5/26/01, child awoke feeling fine. Y 05/24/2001 05/25/2001 1 PUB PUB KS200118 1
0172456 06/26/2001 KS 12.0 12 M 05/22/2001 Within a few minutes after receiving vaccine, the patient fell to the floor and had a few jerking movements. Within a few seconds he was able to speak and was alert. He was monitored for 15 minutes and left with mother. Y 05/22/2001 05/22/2001 0 PUB PUB NONE NONE KS200117 1
0172457 06/26/2001 KS 2.0 2 .7 M 05/04/2001 Patient developed welts all over. The patient was treated with Benadryl. Y 05/03/2001 05/03/2001 0 PUB PUB 5/3/01 Connaught Poliovax, lot #T0471, given SC in LL, 1 previous NONE NONE KS200116 1
0172458 06/26/2001 KS 13.0 13 M 04/20/2001 The patient developed pain in the arm. Two days post vaccine, the site swelled and became red and hot to the touch. The pain began bolting up the arm. Y U 04/17/2001 04/19/2001 2 PUB PUB KS200115 1
0172459 06/26/2001 KS 51.0 51 F 04/23/2001 The patient awoke with extreme dizziness (room spinning) the night of receiving vaccines. The dizziness lasted throughout the next day. The patient also experienced some nausea with the dizziness. Y 03/09/2001 03/10/2001 1 PVT PVT estrogen patch, Baycol NONE wheat allergy, respiratory allergy KS200114 1
0172460 06/26/2001 KS 1.2 1 .2 F 02/27/2001 The day after vaccine the patient was noted to have an erythematous, papular rash over both legs. One week after vaccine, the rash had spread to the buttocks and torso. The patient was diagnosed with exanthem secondary to MMR. Y Y 02/20/2001 02/21/2001 1 NONE PUB PUB NONE NONE NONE KS200111 1
0172461 06/26/2001 GA 3.0 3 F 06/18/2001 No data recorded. Y 06/07/2001 PUB UNK NONE 1
0172462 06/26/2001 CA 40.0 F 06/25/2001 The only vaccine administered was the PPD. Y 06/21/2001 UNK UNK Aventis Pasteur Mantoux PPD, lot #C0631AA, applied to left forearm 1
0172463 06/26/2001 FL 1.0 1 .0 F 06/25/2001 Started with fever. Rash appeared 4 days after, and AOM. Was treated with Zithromax and Atarax. The fever dropped and appeared again 3 days ago. Rash is maculopapular over her face and trunk (urticarial). Intact mucosa. Today treatment with Orapred (oral) N 06/15/2001 06/16/2001 1 CBC ordered on 6/25/01 PVT PUB NONE Obstructive Airway Disease; non-egg allergy 1
0172464 06/26/2001 CA 5.0 M 06/21/2001 Induration and redness around injection site 6cm X 6cm, warm and tender. Increased erythema over 2 days. U 06/19/2001 06/20/2001 1 NONE PVT OTH NONE NONE 1
0172465 06/26/2001 MN 5.0 1 .3 M 06/15/2001 No data provided. Y 01/30/1997 01/30/1997 0 PVT UNK NONE 1
0172466 06/26/2001 NC 4.0 4 F 06/22/2001 Pt noted to have a non-tender 10cm X 7cm local reaction on the left anterior thigh. Complaining of a macular blotchy, blanching rash. Y Y 06/20/2001 06/20/2001 0 NONE PVT PUB NONE NONE NONE 1
0172467 06/26/2001 MI 29.0 F 06/20/2001 Post vax, pt developed 3 or 4 hives on anterior neck at 10:00. Neck reddened and was itchy. No dyspnea or edema. Pt was given 50mg Benadryl po. Further follow-up required. Y 06/19/2001 06/19/2001 0 OTH PVT Zyrtec 1-2 X 1 week; Proventil 1-2 X 1 week NONE Allergies to nuts, animals, trees, weeds, flowers and grass. 1
0172468 06/26/2001 MA 49.0 49 M 06/19/2001 Patient developed left sided jaw pain approximately one week following Td. It is described as an occasional dull ache which becomes painful when trying to open jaw. The patient hears and feels a "squishy" sensation when opening the jaw. Y N 05/30/2001 06/06/2001 7 PUB PUB Aventis Pasteur Tubersol, lot #C0730AB, placed in right forearm, echinasea, ginseng NONE penicillin allergy 1
0172469 06/26/2001 NJ 4.0 4 F 06/20/2001 Patient developed a localized area of redness, heat and swelling. The patient was treated with Keflex. Y Y 06/14/2001 06/16/2001 2 PVT PVT NONE NONE 1
0172470 06/26/2001 OH 15.0 15 F 06/21/2001 Two days post vaccine, the patient developed a raised area at injection site that continued around the shoulder towards the back. The patient also complained of soreness. She was treated with massage. U 06/18/2001 06/20/2001 2 PUB PUB NONE NONE NONE 1
0172471 06/26/2001 OH 5.0 5 M 06/14/2001 Patient developed a 6 inch area of erythema around injection site on left thigh. The area was warm and slightly tender. Symptoms lasted until 6/14/01. Y 06/11/2001 06/12/2001 1 NONE PVT PUB NONE 1
0172472 06/26/2001 CT 5.0 1 .0 M 06/18/2001 Patient was noted to have papular, vesicular lesions and scabs on face, scalp and trunk. Patient was diagnosed with chicken pox vaccine failure. Y 10/30/1996 06/18/2001 1692 PVT PVT NONE 1
0172473 06/26/2001 NE 4.0 4 M 06/18/2001 Patient developed a fever of 103 and swollen, red, cracked lips that developed an infection. The patient recovered completely. Y Y 02/21/2001 02/22/2001 1 NONE PUB PUB NONE NONE NONE Temperature of 103~Hep B (no brand name)~1~4.00~In Patient 1
0172474 06/26/2001 IN 18.0 18 F 06/18/2001 Patient experienced anxiety after receiving vaccines. Y 06/18/2001 06/18/2001 0 PVT PVT Aventis Pasteur TB test, lot #C0824AA, placed in right forearm 1
0172485 06/27/2001 TX 11.0 11 F 06/25/2001 A nurse reported that a pt received an injection of Pnu-Imune 23 and subsequently, developed cellulitis. The pt was treated with IV antibiotics. This is 1 of 2 pts from this facility who experienced cellulitis following receipt of Pnu-Imune 23 (lot 463748). Additional information received on 6/22/01, indicated that an 11 year old female received Pnu-Imune 23 on 5/10/01 and the next day, developed cellulitis. The pt was hospitalized. She recovered. Y 3 Y 05/10/2001 05/11/2001 1 UNK PVT OTH UNK UNK UNK 1432130 1
0172489 06/27/2001 MO 1.01 1 .0 F 06/13/2001 7-10 days, post vax, pt stopped breathing in his sleep, was limp and unconscious. Had to stimulate for more than 30 seconds. About 3 weeks later, the same thing happened again, only worse. Two months later had low heart rate. Uses apnea monitor constantly because apnea occurred frequently. Y Y Y 01/17/2001 01/24/2001 7 3/21/01-Sleep study; EEG-nml; Upper GI-nml; Blood tests-nml PUB PUB NONE NONE NONE 1
0172491 06/27/2001 AL 37.0 37 F Approx. 30 minutes, post vax, employee complained of burning in head, neck and chest area. Then reaction progressing to SOB, wheezing, neck vein distention and then a full blown anaphylactic shock. Pt treated with albuterol 0.5mg/NS; Epinephrine 1:10000 IV Solu-Medrol 125mg IV; Depo-Medrol 80mg IM; O2 per face mask 1.5 liter; BP decreased to 70/43; cold and clammy. Admitted to Critical Care for observation X 48 hours. Discharged home with condition stable and BP 90/70. Y Y Y 2 Y 06/15/2001 06/15/2001 0 Cardiac monitor; 12 lead EKG; Pulse OX PUB PVT NONE Allergies to Librax, Darvon, Betadine, Sulfa 1
0172492 06/27/2001 MD 1.2 1 .2 M 06/19/2001 Pt got vaccines on 6/12/01. The next day, both thighs were swollen and red, left more than right. Y Y 06/12/2001 06/13/2001 1 PVT PVT NONE Failure to thrive; left upper arm weakness 1
0172493 06/27/2001 VA 0.7 0 .6 M 06/12/2001 On 6/12/01, seen by doctor with fever of 103F, nausea and vomiting and diarrhea. CNP says she doesn't think it's related but even if it is, she wouldn't omit vaccines as benefits outweigh the risks. On 6/13/01, called back, and said to give remaining vaccines one at a time. Y U 06/11/2001 06/12/2001 1 PUB PUB VA01018 1
0172494 06/27/2001 WA 7.0 7 F 04/05/2001 Red and swollen area, the size of 7.5cm X 6.5cm, hard in the middle, warm to touch. Fever of 99.7F. Gave Rocephin shots. Y Y 04/02/2001 04/03/2001 1 PVT UNK Ear infection; sinusitis Asthma and allergies WA011755 1
0172495 06/27/2001 PA 0.7 0 .7 F 06/25/2001 On 6/21/01, right leg with 3cm X 3cm red and warm with swelling. Apply cool compresses and use Tylenol; recheck on 6/25/01, rash, fussy, decreased activity, diarrhea, decreased appetite. Possible reaction to Prevnar. Fine papular, blanching and erythematous. Treatment with fluids, Tylenol and Benadryl for 3 days per MD. Y Y 06/20/2001 06/21/2001 1 NONE PVT PUB NONE NONE NONE 1
0172496 06/27/2001 AL 1.08 1 .1 M 06/25/2001 Macular papular (confluent) rash, all over body. N 06/14/2001 06/24/2001 10 PVT PUB Amoxicillin Otitis media NONE 1
0172497 06/27/2001 CO 3.0 3 F 06/17/2001 Left thigh cellulitis beginning within 12 hours, post vax, of Prevnar. Observed for 24 hours with erythema and induration with increasing. Given Ancef and started on Keflex 48 hours, after injection. (Had 2nd Hep-A/MSD/1559K/IM/RL on 3/19/2000) Y Y 06/15/2001 06/15/2001 0 NONE PVT OTH NONE NONE NONE 1
0172498 06/27/2001 FL 0.3 0 .4 M 06/14/2001 At 6/14/01 visit, mom described immunization reaction from 4/19/01 shots as "loud, high-pitched inconsolable crying for five hours and fever of 105F (R)." Mom states pt remained irritable for 24 hours. Mom described injection site (thighs) slightly red without swelling. No treatment by physician. Y 04/19/2001 PVT PUB Oral thrush NONE 1
0172499 06/27/2001 DE 0.5 0 .5 F 06/19/2001 Had vaccines on 3/29/01 and on 3/30/01 began with fever and lethargy. On 3/31/01, fever and lethargy continued and had an episode of choking with her eyes rolling back into her head. Seen at hospital on 3/31/01. Septic work-up done. Had a dose of Rocephin there then again in our office. All labs were negative. Y Y 03/29/2001 03/30/2001 1 CXR; Septic work-up (blood, urine, 0 CSF)-all labs negative. PVT PVT NONE NONE 1
0172500 06/27/2001 CA 0.2 1 .2 F 06/19/2001 Erythema multiform all over body; small erythematous rash on chin, 1 day prior to Prevnar. Dx'd with urticarial rash; erythema multiform. Y 06/13/2001 NONE PUB UNK NONE 1
0172501 06/27/2001 CA 1.0 1 .0 M 06/19/2001 #10; 3-4mm from nodules; no excoriation; no fluid erythematous; no umbilication. 1st lesion, 7 days, post vax. Latest nodule, 12 days, post vax. N 05/31/2001 NONE PVT PVT NONE NONE Undiagnosed mitochondrial 1
0172502 06/27/2001 CT 1.0 1 .0 F 06/20/2001 Persistent Crying/screaming X 8-12 hours. Y Y 02/12/2001 02/12/2001 0 NONE PVT PUB Reglan, Flovent, Zantac, Xopenex NONE Reactive Airway Disease 1
0172503 06/27/2001 MN 0.5 0 .5 F 06/19/2001 Right acute otitis media, fever, fussiness and vomiting, hours after procedure/immunization. Y Y 06/15/2001 06/15/2001 0 NONE PVT PVT OME NONE 1
0172504 06/27/2001 NC 0.25 1 .3 F 06/26/2001 No data provided. Y U 06/25/2001 06/25/2001 0 PVT PUB 1
0172505 06/27/2001 VA 5.0 1 1 M 06/21/2001 Got chickenpox on 6/20/01 and was vaccinated on 6/03/1998. Y 06/03/1998 06/20/2001 1113 PVT PUB 1
0172506 06/27/2001 VA 1.25 1 .3 F 06/21/2001 Got chickenpox on 6/20/01 and had vaccine on 11/3/99. Y 11/03/1999 06/20/2001 595 PVT PUB 1
0172507 06/27/2001 CT 0.25 0 .3 M 06/20/2001 About 12 hours, post vax, infant developed a temperature of 102F with extreme irritability. Temperature lasted 48 hours and irritability lasted 72 hours. Y Y 06/15/2001 06/15/2001 0 NONE PVT PUB NONE NONE NONE 1
0172508 06/27/2001 NH 0.2 0 .1 M 06/20/2001 3 hours, post vax, baby was inconsolable and had a high-pitched scream and decreased feedings X 53 hours. Y 06/02/2001 06/12/2001 10 NONE PVT UNK NONE NONE NONE 1
0172509 06/27/2001 IL 1.0 1 .0 F 06/21/2001 Red knot and rash at immunization site. The follow up states Dr indicated in chart he believed varicella caused reaction. Y 06/12/2001 06/14/2001 2 OTH PUB Pulmicort Respules NONE NONE 1
0172510 06/27/2001 IN 0.5 0 .5 F 06/20/2001 Developed a high fever of 104.2F, during the evening after shots given. Evaluated in ER. Irritable with fever, no focal injection. Evaluated for possible sepsis and given IM Rocephin X 1. Y Y 06/18/2001 06/18/2001 0 6/19/01-WBC-19,700; 74% S; 14% L; Blood C & S (-); 6/20/01-WBC-9,900; 61% S; 32% L PVT PVT NONE 1
0172511 06/27/2001 HI 1.5 1 .6 M 06/20/2001 Received DTAP and Prevnar in left thigh. About 24 hours later, developed redness and swelling. No fever. On exam, pt afebrile. There is a 5cm X 9cm area of induration and erythema. No pain, tenderness, drainage or fluctuance. Treat symptomatically with cool compresses and Tylenol prn. Y Y 06/19/2001 06/20/2001 1 NONE PVT PUB NONE NONE Atopic dermatitis, pityriasis alba 1
0172512 06/27/2001 CA 3.0 3 M 06/20/2001 Left deltoid was red, hot and swollen 5cm X 5cm, within 24 hours of Prevnar. Y 06/13/2001 06/14/2001 1 NONE PVT PVT TB skin test/RFA Conjunctivitis NONE 1
0172513 06/27/2001 FL 0.3 0 .3 M 05/13/2001 Pt had a seizure on 4/11/01. I brought him to the ER where they did blood work. His iron was low (Hgb) 10.3; Hct 28.7 and he was also given an EEG which was normal. Y U 03/30/2001 04/12/2001 13 Blood work, iron was low (Hgb) 10.3; Hct 28.7 and an EEG which was nml. PVT OTH Had Bronchitis, 2 weeks prior; possible allergies 1
0172514 06/27/2001 CO 4.0 4 M 06/17/2001 Onset of cellulitis/erythematous and induration within 12 to 24 hours, post vax. Fever to 100F, 24 hours, post vax with erythema, pain and induration increased to triple size within 48 hours, post vax. Dx'd with cellulitis. Treated with Keflex X 7 days. Y Y 06/15/2001 06/16/2001 1 NONE PUB OTH NONE NONE NONE 1
0172515 06/27/2001 NH 1.0 1 .1 M 06/19/2001 Fever of 104.5F (axillary). Another child had a 104F temperature after receiving MMR (1661J) on the same day. Y U 06/11/2001 06/18/2001 7 PVT PUB NONE Allergic to Amoxicillin 1
0172516 06/27/2001 NH 53.0 53 F 05/30/2001 Patient first noted edema and joint pain in the Fall of 2000. She developed eye pain in the winter of 2000. She developed Raynaud's Syndrome in January 2001. She has also developed back pain. Patient given second Lymerix vaccine on 8/25/00 and the third in December of 2000. Y N 07/28/2000 Diagnostic tests inconclusive PVT OTH Synthroid, Prempro NONE Hypothyroidism, menopause 1
0172517 06/27/2001 PA 34.0 33 M 06/19/2001 Patient developed muscle and joint aches and pains requiring disability from employment. Patient also developed swelling in hands and severe general body pain. Permanent disability is to be determined. First dose of Smith Kline Lymerix, lot #LY146A9, given 6/17/00. Y N 07/27/2000 03/03/2001 219 HLA-DRY pos; active Lyme disease by PCR-neg PVT OTH 1
0172518 06/27/2001 AZ 45.0 44 M 06/07/2001 Approximately 3 months after receiving last vaccine, patient developed arthralgias, myalgias, weakness of bilateral lower extremities, paresthesia, fasciculations, vertigo, visual problems, mental lapses and depression. The symptoms mostly resolved over 6-8 months. No therapy was given. A follow up report received 6/19/2002 adds: Recipient still experiences leg weakness, muscle twitches. N 04/24/2000 05/04/2000 10 CT, MRI, heavy metal screening, evoked potentials, full blood lab work including CBC, Chem panel, LFT, carotid US, stress EKG MIL MIL benign positional vertigo, hypospadias 1
0172519 06/27/2001 CO 46.0 46 M 04/03/2001 Patient developed an extremely large local reaction extending one joint above and one joint below shot site. The area resolved slowly without treatment. Y 12/30/2000 01/03/2001 4 NONE MIL MIL NONE NONE NONE 1
0172520 06/27/2001 VA 31.0 31 M 06/15/2001 Patient developed a 4 day history of left arm itching. U 06/09/2001 06/11/2001 2 NONE OTH MIL NONE NONE NONE 1
0172521 06/27/2001 IL 89.0 89 F 06/15/2001 Patient developed a severe contusion-appearing, firm area on arm at site of injection. This lasted greater than one month. Y 11/08/2000 11/12/2000 4 NONE UNK UNK hypertension, actinic keratosis, diabetes, overweight, osteoarthritis of thumb 1
0172522 06/27/2001 NY 1.3 1 .4 M 06/20/2001 Patient developed left arm swelling from deltoid area down to elbow 2 days following vaccine. Patient also developed a temperature of 101.5 to 102.9 for 2 days following vaccines. Y Y 05/29/2001 05/30/2001 1 PVT UNK ~DTaP (no brand name)~3~0.50~In Patient 1
0172523 06/27/2001 OH 74.0 74 F 05/25/2001 Patient broke out in hives between legs, on back of upper thighs, back, shoulders, neck and behind ears starting 5/24/01 at 11 PM. It got worse, and she went to the ED at 1:45 AM when lips began to swell. She complained of increased blood pressure. She was given mild IV steroid and IV Benadryl. Y Y 05/23/2001 05/24/2001 1 NONE PUB PUB Synthroid, Famvir, Timoptic NONE Mosquito bite allergy,glaucoma OH0036 1
0172524 06/27/2001 OH 1.5 1 .5 F 04/09/2001 Patient became lethargic with a fever of 105. She was taken to the emergency room and kept for observation for several hours. Tylenol suppository was given, and fever decreased. Patient had a low-grade fever that lasted 3-4 days. Y Y 03/23/1990 03/30/1990 7 PUB PUB NONE NONE NONE OH0035 1
0172525 06/27/2001 OH 41.0 41 M 05/10/2001 Approximately 7 hours after receiving vaccine, patient developed flu-like symptoms of body aching, fatigue and low grade fever for 2 days. Y 03/15/2001 03/15/2001 0 NONE OTH PUB Levaquin pneumonia penicillin allergy flu-like symptoms~Influenza (Seasonal) (no brand name)~0~32.00~In Patient OH0034 1
0172526 06/27/2001 OH 49.0 49 F 05/10/2001 Thirty minutes after receiving vaccine the patient developed a pinpoint rash on bilateral forearms and tightness in the throat. The patient became anxious. Y 03/15/2001 03/15/2001 0 NONE OTH PUB estrogen NONE penicillin allergy OH0033 1
0172527 06/27/2001 OH 1.25 1 .3 M 05/24/2001 On day of vaccine, pt developed temp of 101.5. He was irritable and refused to eat. There was a lump at the injection site which was also red and warm to touch. Below injection site there was a red rash. The fever responded to Tylenol. On 5/22/01 the rash looked worse and MD prescribed Tylenol per phone call. Pt. continued with low grade fever and had diarrhea x 4. On 5/23/01 pt. still had a low grade fever and lump remained at site but rash was fading, had nor further diarrhea, and was less irritable. Y 05/21/2001 05/21/2001 0 NONE PUB PUB NONE NONE NONE OH0032 1
0172528 06/27/2001 OH 0.2 0 .2 F 06/13/2001 On day of vaccines pt became extremely fussy and cried for 2 days. The crying was inconsolable. Same reaction occurred in twin sister. Y 04/17/2001 04/17/2001 0 NONE PUB PUB Tylenol NONE Prematurity ~DTaP (Infanrix)~1~0.20~In Sibling OH0031 1
0172529 06/27/2001 OH 0.2 0 .2 F 06/13/2001 On day of immunizations, patient developed extreme fussiness and cried for 2 days. The crying was inconsolable. Mother reports the child will not take bottle since episode (breast feeding). Y 04/17/2001 04/17/2001 0 NONE PUB PUB Tylenol NONE Twin, 3 weeks premature ~DTaP (Infanrix)~1~0.20~In Sibling OH0030 1
0172530 06/27/2001 OH 1.0 1 .1 F 06/06/2001 The afternoon of receiving vaccines the patient had a slight temperature and was fussy with no appetite and possible nausea. Patient developed a solid, red band across forehead from ear to ear slightly involving the eyes. The band came and went for 1 day. The next day the patient was whiney and lethargic but was fine after that. The patient was seen on 2/22/01 for vomiting and diarrhea. Patient was seen in the ED on 2/23/01 with vomiting, diarrhea and red facial rash and was diagnosed with gastroenteritis. Y Y 02/21/2001 02/21/2001 0 PUB PUB Mantoux TB test NONE NONE OH0029 1
0172531 06/27/2001 MA 6.0 1 .5 M Patient developed varicella lesions over trunk and back ranging from erythematous macules to vesicles. Y Y 11/13/1996 NONE PVT PUB 1
0172533 06/27/2001 KS 23.0 23 F 03/13/2001 Patient awoke 1 day post vaccine with severe headache, malaise, dizziness, lightheadedness, and paleness. Patient was seen at clinic with pallor, fatigue and lightheadedness. Y Y 03/12/2001 03/13/2001 1 BP 100/70 PUB PVT Birth control pills NONE Allergy to cats, dogs, mold KS200112 1
0172534 06/27/2001 WA 5.0 5 M 03/26/2001 Patient developed spots on left arm. Clinic revisit showed patient had redness and swelling of left upper arm that was warm to the touch. Y U 03/20/2001 03/21/2001 1 PUB PUB UNK UNK WA011754 1
0172535 06/27/2001 WA 34.0 34 F 04/18/2001 One hour after receiving vaccine, the patient developed nausea and tiredness. She also developed an intense, pounding headache. Patient was treated with Imitrex without relief. She went to the clinic and was treated with 2 Advil and 2 Excedrin with relief. As of 4/18/01, the patient had no nausea and a slight headache treated with 2 Advil. Y Y 04/16/2001 04/16/2001 0 NONE PUB PVT Connaught PPD, lot #152AA, placed in left forearm, Imitrex, Effexor NONE WA011757 1
0172536 06/27/2001 NE 5.0 5 F 06/09/2001 The evening of receiving vaccines, the patient developed a fever of 102. For the next 6 days, she spiked temperatures from 101-105. She developed vomiting on day 2 and swelling of the injection site of the MMR on day 5. She was asymptomatic by day 8. Y Y 06/01/2001 06/01/2001 0 WBC, CK, comprehensive profile, throat culture, ESR-wnl PVT PVT NONE NONE Congenital vocal cord paralysis, right sensorineural hearing loss, right labial mass 1
0172537 06/27/2001 TX 4.0 4 M 06/13/2001 Patient developed a 10 by 16 cm area of redness and warmth at injection site 48 hours after receiving MMR vaccine. He was treated with Benadryl and cool compresses. Y Y 06/11/2001 06/13/2001 2 PVT PVT NONE NONE NONE 1
0172538 06/27/2001 CO 1.0 1 .0 M 06/20/2001 Patient developed an approximately 5 cm circular, localized swelling, pinkness and blanching at site of varicella vaccine. Benadryl was given and within 20 minutes the size of the reaction was receding. Patient had no further signs and symptoms noted. Follow up on 6/20/01 showed the symptoms were totally cleared. Y 06/19/2001 06/19/2001 0 NONE PVT OTH NONE NONE NONE 1
0172539 06/27/2001 CA 4.0 4 F 06/18/2001 Patient was seen for follow-up of PPD on 6/18/01 and was noted to have a 0.5 cm area of circular thickening on right upper arm surrounded by a 2.0 cm round area of warmth, erythema and slight edema. The area was tender to palpation. N 06/12/2001 06/12/2001 0 PVT PVT NONE 1
0172541 06/27/2001 WA 1.5 1 .5 F 06/20/2001 Patient developed redness and swelling of right arm from shoulder to wrist 24 hours after receiving vaccines. The patient also developed several hives. The redness and swelling improved with antihistamines. Y Y 06/15/2001 06/16/2001 1 NONE PVT PUB amoxicillin sinusitis NONE 1
0172542 06/27/2001 CO 1.4 1 .4 F 06/17/2001 Patient developed a low grade fever, nausea, vomiting and a papular, red rash on torso, face and extremities 10 days post vaccination. Y U 05/22/2001 06/01/2001 10 NONE PVT PVT NONE NONE NONE 1
0172543 06/27/2001 OR 1.9 1 1 M 06/20/2001 Patient developed a 6-8 cm diameter area of erythema and moderate edema around injection site. U 06/18/2001 06/19/2001 1 PVT PVT NONE NONE NONE 1
0172544 06/27/2001 FL 23.0 23 F 06/20/2001 Patient did not have any reaction to vaccine but wanted to document that she was pregnant 1 week prior to vaccine. U 05/31/2001 MIL MIL NONE 1
0172545 06/27/2001 FL 2.9 2 .9 F 06/20/2001 Patient developed localized redness and cellulitis. 06/15/2001 06/16/2001 1 NONE PVT PUB NONE NONE 1
0172546 06/27/2001 MN 1.08 1 .0 F 06/21/2001 Patient developed a vesicular rash with greater than 200 pox. Patient complained of a stomachache prior to breaking out and headaches. Patient was very fussy and had symptoms of an upper respiratory infection. She required Albuterol nebulizer. Y Y 07/08/1997 06/15/2001 1438 PVT PVT NONE probable viral exanthem reactive airway disease diagnosed 2/25/00 1
0172547 06/27/2001 NV 22.0 22 F 06/20/2001 Patient developed pain in all joints, a rash on both legs and a fever on day of vaccination. Patient saw physician on 6/17/01 and was prescribed pain pills and hydroxyzine for rash. The patient also complained of dizziness and shortness of breath. As of 6/21/01, the rash was resolving. Y Y 06/15/2001 06/15/2001 0 PUB PUB NONE NONE NONE 1
0172548 06/27/2001 FL 30.0 30 F 06/11/2001 Patient reported nausea, vomiting, joint pain, numbness and tingling in both arms, a rash over neck, arms and trunk, and a feeling of shortness of breath. Y 05/10/2001 05/11/2001 1 PVT UNK NONE NONE 1
0172549 06/27/2001 MD 15.0 15 M 06/22/2001 Patient developed a mild exacerbation of asthma. Y 06/13/2001 06/14/2001 1 Peak flow at home PVT PVT Flovent, Albuterol asthma Vaccine reaction~Measles + Mumps + Rubella (MMR II)~1~10.00~In Patient 1
0172550 06/27/2001 WI 61.0 61 F 06/15/2001 On 6/14/01 the patient developed vomiting, low grade fever, joint ache and fatigue. She later developed diarrhea. On 6/15/01 she had no vomiting but still had diarrhea, fatigue and joint pain. 06/04/2001 06/14/2001 10 MIL PVT 6/4/01 Aventis Pasteur PPD, lot #0123IP, placed in left forearm. 6/13/01 Aventis Pasteur PPD, lot #0123IP, placed in left forearm NONE No known allergies 1
0172551 06/27/2001 WI 19.0 19 M 06/20/2001 Patient complained of mild itching within 5 minutes of receiving vaccine. After 15 minutes, the itching had resolved. Approximately 2 hours later, the patient called and complained of a rash all over. The patient was instructed to go to the ED where he was treated with IV Benadryl, Pepcid and Solumedrol for hives. Y Y 06/19/2001 06/19/2001 0 OTH OTH NONE NONE NONE 1
0172552 06/27/2001 TX 28.0 28 F Patient developed an 8 x 5 cm area of redness, heat and swelling. Patient was seen by urgent care physician on 6/3/01 and treated with antibiotics. She was seen by PCP 6/5/01 at which time the area was still very red, swollen and warm to the touch. Y Y 05/31/2001 06/01/2001 1 PVT PVT 1
0172553 06/27/2001 FL 1.2 1 .1 F 06/14/2001 Patient developed a morbilliform rash. Y 06/01/2001 06/08/2001 7 PVT OTH NONE NONE 1
0172554 06/27/2001 NY 11.0 11 F 06/21/2001 Patient developed generalized urticarial rash/hives within 2 hours of receiving Hepatitis B vaccine. Y Y 06/19/2001 06/19/2001 0 PVT OTH NONE NONE NONE 1
0172555 06/27/2001 CA 72.0 72 F 06/15/2001 Approximately 12 hours after injection, the patient developed extensive local erythema. Y 06/14/2001 06/14/2001 0 PVT UNK diabetes mellitus, questionable osteomyelitis diabetes mellitus 1
0172556 06/27/2001 AZ 4.0 4 M 06/05/2001 Patient developed a fever of 102.7 and redness, swelling and warmth at injection site. Y Y 04/07/2001 04/08/2001 1 PUB PUB NONE NONE 1
0172557 06/27/2001 OR 49.0 49 F 06/19/2001 Patient developed induration of greater than 10 cm at site of injection. Patient had anesthesia in same hand and wrist. Patient experienced body pruritus. Patient was seen on 6/19/01 at which time the induration measured 4 cm. Y 06/14/2001 06/15/2001 1 NONE PVT PVT Aciphex NONE NONE 1
0172558 06/27/2001 TN 4.0 F 06/21/2001 Patient developed cellulitis, erythema, induration, tenderness and heat in a 3 x 5 cm area around injection site on left thigh. Y 06/18/2001 06/19/2001 1 PVT PVT NONE NONE 1
0172559 06/27/2001 NY 1.5 1 .5 F 06/22/2001 Patient developed urticaria. She was treated with Benadryl. Y Y 06/21/2001 06/21/2001 0 PVT PVT otitis media 1
0172560 06/27/2001 CA 17.0 17 F 06/11/2001 Patient developed hives the evening of receiving vaccine. The next morning the patient noted her lips were swollen and the hives had progressed. The patient ate Indian food for the first time on the evening of 6/8/01. Y Y 06/08/2001 06/08/2001 0 PVT PVT NONE NONE 1
0172561 06/27/2001 NH 21.0 21 M 06/21/2001 The morning after vaccine, the patient awoke with nausea and fever. By the afternoon, his temperature was 103, and he had shaking chills. He took ibuprofen. By 5/12/01, the fever was gone. He reported slight muscle tenderness at the site. As of 5/14/01, the patient reported feeling fine. Y 05/10/2001 05/11/2001 1 PVT PVT Cleocin-T furunculosis, hyperlipidemia 1
0172562 06/27/2001 GA 1.0 1 .5 M 06/26/2001 Patient developed low grade fever and inconsolable crying. U 06/21/2001 06/21/2001 0 NONE MIL MIL Tylenol NONE NONE 1
0172564 06/28/2001 OH 0.5 U 06/26/2001 A physician reported that a 6 month old received 2 doses of Prevnar and was hospitalized on 6/21/01 due to coma. An unspecified culture was reportedly positive for gram diplococci. As of the date of this report, no further information was available. Additional information received from company representative on 07/07/2001, subsequent to 2nd dose of Prevnar immunization, infant developed acute otitis media and was treated with Amoxicillin and Augmentin. On 06/21/2001, the infant developed penicillin resistant pneumoccocal meningitis. the infant waw switched to vancomycin, meropenen, and rifampin for 3 weeks. Y U 06/21/2001 Culture NOS positive-reportedly gram diplococci. Laboratory data includes MRI which identified multiple infarcts and questionable brain stem involement. Serotype indentified as 23F streptococcus pneumoniae. The reporter noted that the hospital was willing to send the culture to Wyeth if requested PVT OTH UNK UNK UNK HQ2480725JUN2001 1
0172565 06/28/2001 0.5 0 .5 M 06/26/2001 The pt was a 5 month old male who received his 2nd dose of Prevnar on 8/4/97. Approx. 2 months, post vax, (at 7 months of age), the pt developed an infected thyroglossal duct cyst. A culture from 9/26/97, revealed Streptococcus pneumoniae serotype 23A. The event was considered to be "Medically Important". Both the investigator's and medical monitor's assessment of the relatedness between infected thyroglossal duct cyst, (expected per the US package insert) and Prevnar was unknown. This represents all the information that we have received to date, regarding this case; additional information will be forwarded when it is received. Previous dose of Prevnar was given on 5/6/97. Both the investigator and the medical monitor consider the events to be not related to vaccine administration. U 08/04/1997 09/26/1997 53 Culture NOS positive-9/26/97-specimen revealed streptococcus pneumoniae serotype 23A UNK UNK UNK HQ2185018JUN2001 1
0172566 06/28/2001 51.0 M 06/25/2001 Information has been received from an investigator concerning a 51 year old male who received placebo for influenza virus vaccine, trivalent, types A & B, live cold adapted (frozen)(nasal solution) along with 1998-99 formula inactivated influenza virus vaccine (mfr unk) on 11/4/98 as part of a clinical trial. The pt experienced a mild exacerbation of chronic obstructive airways disease and was hospitalized. The subject also stated his post traumatic stress disorder was acting up and if he was not admitted to the hospital at that time, he may kill himself. The investigator felt the exacerbation of chronic obstructive airways disease was "possibly related" to study product or concomitant vaccine administration. The medical monitor's assessment was unknown. Y Y 11/04/1998 02/21/1999 109 NONE UNK UNK UNK Chronic obstructive airways disease; peptic ulcer; benign prostatic hyperplasia; post-traumatic stress disorder HQ2344421JUN2001 1
0172572 06/28/2001 PA 0.75 0 .8 M 06/04/2001 Pt presented to local ER on 5/17/01 with respiratory failure. Intubated and transferred to another hospital where he did well and was discharged home on 5/19/01. Dx was a suspected ingestion. Seen in office of 5/25/01 and doing well. Y Y Y 3 Y 05/14/2001 05/17/2001 3 PVT PVT NONE NONE NONE 1
0172573 06/28/2001 IL 1.0 1 .0 F 06/27/2001 Varicella - like rash mainly face and torso. Y 05/29/2001 06/22/2001 24 PVT PVT NONE NONE 1
0172574 06/28/2001 IA 5.0 5 M 06/27/2001 Erythema, swelling and pruritis of entire upper arm surrounding injection site. Y Y 06/25/2001 06/27/2001 2 NONE PVT PVT NO NO 1
0172575 06/28/2001 MI 4.0 4 M 05/21/2001 One wk after immunization pt was irritable, starring off, not eating. Going to bed at 12 midnight. nml bedtime 8-8:30. Poor coordination. Holding head when asked what's wrong, by mother seemed to have difficulty expressing self. Y Y 05/09/2001 05/16/2001 7 PUB PUB NONE NONE NO KNOWN 1
0172576 06/28/2001 CA 1.25 1 .3 F 05/31/2001 Local induration, redness, temp of 102 x 2. 5/30 fever, 5/31 redness, induration. Y 05/30/2001 05/30/2001 0 PUB PVT 1
0172577 06/28/2001 23.0 23 M 06/02/2001 Erythema with induration - 8cm diameter at injection site. Y 05/30/2001 05/31/2001 1 MIL MIL NONE 1
0172578 06/28/2001 MI 1.0 1 .2 M 05/17/2001 Child had HIB vaccine. 14 hrs later pt developed 1 hive on chest and mild congestion. Congestion resolved after 1 day. Hive fading but still present. Did not seek care. Y 05/14/2001 05/15/2001 1 PUB PUB MI2001046 1
0172579 06/28/2001 NC 1.5 1 .5 M 06/18/2001 Cellulitis around DTaP injection site at 48 out. + fever but none in MD office. Y Y 06/14/2001 06/15/2001 1 PVT PUB Augmentin, Zantac, Zyrtec, Xopenex NO Allergy to egg, nut, peanut. Asthma, eczema, allergic rhinitis. 1
0172580 06/28/2001 WA 5.0 5 M 06/20/2001 24 hrs post injection of DTaP redness, swelling and tenderness L deltoid. At 48 hr, erythema and warmth measures 6x8cm. Some tenderness Y Y 06/13/2001 06/14/2001 1 NA PVT PUB NA NA Asthma 1
0172581 06/28/2001 GA 38.0 38 F 06/21/2001 Painful knot at injection site, heat at injection site. Tiredness. Local reaction 3cm x 2cm. 06/18/2001 06/18/2001 0 MIL MIL IPPD/Conn/Co152aa/SQ/LFA Biaxin allergy 1
0172582 06/28/2001 MS 4.0 3 F 06/04/2001 Five min. after vaccine, pt started complaining of throat pain. followed by vomiting, heaving. Pt became completely pale, lips became ? cyanotic and heart rate increased. Benadryl 25mg was immediately administered. Respiratory rate and breaths sounds monitored closely, 911 called and pt taken to ER. Y Y 06/04/2001 06/04/2001 0 PVT PUB NONE NONE 1
0172583 06/28/2001 GA 10.0 10 M 06/27/2001 Onset of erythema 4x4cm & induration 3x3cm at injection site beginning 12 hrs after vaccine. Progressed to 11cmx11cm erythema induration unchanged within 24 hrs - resolved by 72 hrs. Also c/o itching/tenderness at injection site and itching on upper chest. Denies fever, ?, SOB,throat swelling. Y 06/18/2001 06/18/2001 0 OTH PUB Albuteral prn NONE Asthma 1
0172586 06/29/2001 MA 60.0 60 F First shot of Lymerix on 5/13/99, 6/99 and 7/99. Immediately, had flu-like symptoms, lung problems, swollen glands, nausea, dizziness and fever on and off since until now. Dx'd with RA. I have since been declared disabled because I can hardly walk and am in constant pain. I am always sick and was in perfect health up until I had Lymerix. I never had Lyme Disease. Y N 05/13/1999 05/20/1999 7 UNK UNK Paxil Anxiety and depression 1
0172590 06/29/2001 CT 1.2 1 .2 M 06/23/2001 The pt experienced fever, cough, purulent rhinitis, persistent high fever, lethargy, dehydration, viral exanthema. Diagnosed with OM and neutropenia. Y 3 Y 04/05/2001 04/12/2001 7 CBC - neutropenia PVT PVT NONE NONE GERD 1
0172591 06/29/2001 TX 2.7 2 .7 M 06/07/2001 Tender leg and temperature at 100.2F about 15 hours, post vax, associated with multiple insect bits with area of 1 1/2" erythema at groin, not at site of injection. Muscle diffusely tender with some decreased motion at left hip. Admitted with cellulitis versus vaccine reaction. Y Y U 06/06/2001 06/07/2001 1 PUB PUB Amoxicillin Pneumonia/OM-resolving NONE per reporter, anemia and heart murmur per mother 1
0172592 06/29/2001 CT 1.25 1 .3 F 06/23/2001 Fever &erythema multiforme plus swelling of eyes,hands, and feet. Better for 9 days. Diarrhea and vomiting, fever x 4-5 days, joint pain and fever. Y N 04/17/2001 04/24/2001 7 Sed rate 57, Urine- nml, Lyme Titer - neg, CBC - neg. PVT PVT NONE NONE NONE 1
0172593 06/29/2001 GA 1.0 1 .0 M 06/21/2001 Has approx 20 pox over body. U 06/12/2001 06/21/2001 9 NONE PVT PUB Amoxicillin BOM NONE KNOWM 1
0172594 06/29/2001 WA 0.2 0 .2 M 06/19/2001 Mom report post vaccine's about 4-6 hrs later baby became fussy, irritable - no fever. Then noted baby became lethargic (baby not limp) but color very pale - yellow-shallow look. Gave tylenol 20-30 min, post tylenol - symptoms totally resolved and seemed normal there after no vomiting, no diarrhea. Y 04/30/2001 04/30/2001 0 PVT PUB NONE NONE 1
0172595 06/29/2001 NM 1.4 1 .4 M 06/15/2001 36 hrs post vaccine increased rash, red, warm macule developed over deltoid region on upper L arm. No fever, pain or pruritus. Y Y 06/13/2001 06/15/2001 2 NONE PVT PUB Zyrtec (after vaccine administered) Allergic rhinitis NO NM060005 1
0172596 06/29/2001 PA 0.2 0 .2 F 05/04/2001 Inconsolable crying last 2-3 hrs, 3-4 x day, decreased appetite, feeding. No fever, no local inflammation, no other apparent neurologic sequelae N 04/30/2001 04/30/2001 0 PVT PVT NONE NONE 1
0172597 06/29/2001 GA 0.5 0 .5 M 06/21/2001 According to mother child awoke from sleep 12 hrs after receiving shot with fever of 105F, lethargy. Called on-call nurse line to report. Fever resolved child well. Y 09/20/2000 09/21/2000 1 NONE PVT PVT NONE NONE 1
0172598 06/29/2001 CT 1.0 1 .0 F 06/23/2001 Urticaria/erythema multiforme. Progressive despite stopping Amoxicillin; swelling of hands and feet - started on po steroids with resolution. Y Y 03/19/2001 03/20/2001 1 Urinalysis - neg PVT PVT Amoxicillin. Ventolin Resolving URI, bronchitis NONE 1
0172599 06/29/2001 OH 0 .1 M 06/28/2001 1 day after vaccine, pt was noted to be very pale "face white", all day & slept more and vomited twice. He was alert when awake but stayed pale x 24 hrs. then returned to normal. ? fever also noted with pallor. Y 05/10/2001 05/11/2001 1 PVT PVT Tylenol infant drops before vaccination NONE NONE 1
0172600 06/29/2001 TX 0.5 0 .5 F 06/27/2001 Hives, benadryl, Pred- 5/5cc Y 06/25/2001 06/27/2001 2 PVT PUB 1
0172601 06/29/2001 GA 1.08 1 .0 F 06/19/2001 Urticaria developed about 2cm distal to the injection site on the L thigh. No systemic allergic response was noted during subsequent observation. Benadryl 6.25mg given po. Y 06/19/2001 06/19/2001 0 PVT PVT NONE 1
0172602 06/29/2001 WA 5.0 5 M 06/20/2001 Mom reports fever 104.5F, extreme lethargy, increased irritability and fussiness, at appointment time fever 102F via tympanic thermometer. Tired but cooperative. Dx likely DTaP reaction vs early flu sx. No evidence of encephalitis. Y 06/18/2001 06/18/2001 0 PVT UNK Fluoride NKDA 1
0172603 06/29/2001 NM 1.08 1 .1 F 05/29/2001 First pix noticed on legs 5/15/01. Saw private physician on 5/17/01. No treatment was given. Mom used over the counter calamine lotion. Child was covered head to toe with pox. Y Y 05/14/2001 05/15/2001 1 NONE PUB PUB NONE NONE per mom 5/14/01 Heart murmur NM060003 1
0172604 06/29/2001 NM 11.0 11 M 04/29/2001 Student broke out in a cold sweat, stated he fainted and was to weak to walk. b/p 82/60, P74, R24 and ? O2 at 6L face mask was initiated & legs elevated and juice given. After 10min b/p 110/70. Light headness subsided & students color returned. He was always oriented x 3 & PERRLA episode lasted 10-15 minutes & slowly subsided with 02, juice, crackers & elevated legs. Y 04/24/2001 04/24/2001 0 Vitals only OTH PUB N/A N/A N/A NM060004 1
0172605 06/29/2001 NM 60.0 60 F 05/12/2001 Post injection body aches, R arm pain 24 hrs later 8x4cm indurated with clear blisters. 5/29/01 dizzy, lethargic, joint pain, shoulder, neck hurt. Given Augmentin 500mg. N 05/11/2001 05/11/2001 0 CMP, CBC, Sed Rate done5/29/01 PVT PVT Ativan, Fiorinal In for physical NONE KNOWN NM060001 1
0172606 06/29/2001 NM 65.0 65 F 05/29/2001 5/14/01 returned with red, hot,indurated area. Given Augmentin 500mg x 5 days. Y 05/10/2001 05/12/2001 2 NONE PVT UNK In for physical Cephalexin NM060002 1
0172607 06/29/2001 NC 49.0 49 F 06/22/2001 Immunization given 6/20/01, MMR and Td same day symptoms. Lungs burning, throat burning with mucus gathering in back of throat. Pt states 6/21/01 was hoarse and couldn't went to ER. X-ray taken of lungs, x-ray neg per pt. Was given? 4mg. Pt stated 6/22/01 was better. Y Y 06/20/2001 06/20/2001 0 X-ray, lab's drawn (pt stated not sure what) PUB PUB 1
0172608 06/29/2001 NC 38.0 38 F 06/18/2001 Pt began to feel numbness L side of face 6/14/01. No headaches, no difficulty swallowing. No breathing problems. Redness/swelling @ injection site 6/11 to 6/12. N 06/11/2001 06/14/2001 3 Note: Pt reports (after the injection) similar "reaction" to Td 4/11/91. States had MRI after that episode with no significant findings. Recovered completely. PUB PUB Ortho-Cyclen NONE NONE NC01055 1
0172609 06/29/2001 NV 29.0 28 F 06/20/2001 Client states she was covered in a rash from head to toe. States her hands and face were swollen. felt heaviness in chest also c/o headache. Y 06/14/2001 06/15/2001 1 PUB PVT NONE NONE NONE 1
0172610 06/29/2001 VA 0.2 0 .2 F 06/22/2001 High pitched incident screaming for 2hrs started 4 hrs after injection. Tylenol given. Y 06/18/2001 06/18/2001 0 N/A PVT UNK NONE N/A NONE 1
0172611 06/29/2001 WA 36.0 35 F 06/15/2001 2" diameter red, hot, painful induration. Cold compresses. Y 06/02/2001 06/03/2001 1 PUB UNK NONE NONE 1
0172612 06/29/2001 MD 38.0 38 M 06/25/2001 Vaccine 6/21/01 3:30pm, 6/22/01am noticed vesicular bump ulnar wrist of arm vaccinated. PM was warm noted chest/back mottled rash - remained through 6/25. Headache 6/22 & 6/23. Arm axcillary noted enlargement /tenderness 6/22,6/23. Symptoms decreasing. 06/21/2001 06/22/2001 1 None done. Will titer for in 30 days. PUB PUB NONE NONE - URI 2 weeks earlier. NONE KNOWN 1
0172613 06/29/2001 OR 54.0 54 M 06/28/2001 Severe urticaria beginning 24 hrs after 2nd HEP B vaccine. Y Y 06/01/2001 06/12/2001 11 MIL PUB NONE NONE NONE 1
0172614 06/29/2001 WA 1.08 1 .1 F 06/27/2001 Vaccine's given 6/22, fever started 6/24. Seen in office 6/27/01, fever to 105.5, no rash, runny nose, cough, loose stools x 2 days. Given Cefzil for Sinusitis. (allergic to PCN) U 06/22/2001 06/24/2001 2 PLT count 160 PVT PUB Mild runny nose Penicillin allergy 1
0172615 06/29/2001 AZ 4.0 4 F 06/27/2001 Hives developed a few hours post vax. Y 06/26/2001 06/26/2001 0 PVT UNK 1
0172616 06/29/2001 OH 1.4 1 .3 F 06/05/2001 Mother reported decreased appetite, irritable, awakening at night unable to sleep. Fever 102.9F decreased with cool bath. Tylenol/ Advil fever to 100.5F. Lethargic, decreased fluid, paleness of lips, small spot L cheek, rash covered body, 6 days rash still on abdomen. Y 05/21/2001 05/23/2001 2 NONE PVT PVT NONE NO NO ~DTP (no brand name)~2~0.30~In Sibling 1
0172617 06/29/2001 MD 7.0 7 F 06/19/2001 With in 2-5 min after getting immunization pt slumped down on the door where she was standing,her arms became somewhat rigid. No seizure activity noted. Pt responded within 15-20 seconds and said I must have been sleeping. Her color did not change, skin not clammy, respiration appeared nml, HR felt but not counted. Y Y 06/15/2001 06/15/2001 0 OTH PVT NONE KNOWN NO NONE KNOWN ~Hep A (Havrix)~~0.00~In Sibling 1
0172618 06/29/2001 MD 9.0 9 F 06/19/2001 Pt fainted and hit her head when she fainted. I did not notice any seizure activity. Y Y 06/15/2001 06/15/2001 0 OTH PVT NONE KNOWN NO NONE KNOWN 1
0172619 06/29/2001 TX M 06/01/2001 Diarrhea. A father reported that his son now 3 yrs old,may have received an injection of RotaShield. The child has experienced chronic diarrhea off and on since 7/2000. No further information was available at the date of this report. U OTH OTH UNKNOWN UNKNOWN Bronchiolitis HQ8676321MAR2001 1
0172621 07/02/2001 FL 1.0 1 .0 M 06/23/2001 Approximately 10-15 minutes post vax, the pt's mom noted blotchy skin, and alerted staff. The Child had grunting respirations at 44 per minutes, BBS, CTA, ears reddened bilaterally, rash to extremities, upper eyelids swollen. The pt was given epinephrine and Benadryl and was admitted for observation. The pt was discharged on 6/23/01. Y 1 Y 06/22/2001 06/22/2001 0 PVT PUB allergy to latex, spina bifida shunt 1
0172622 07/02/2001 PA 13.0 13 F 11/13/2000 The pt developed numbness in the toes, fingers, tongue and vaginal area occurring 5 days post vax which progressively got worse. The pt was sent to the ER. The pt was admitted to the hospital with a diagnosis of Guillain Barre and was treated with IV IgG. Y Y 12 U 10/12/2000 10/17/2000 5 Testing done at hospital resulted in dx of Guillain-Barre Syndrome PVT PVT NONE URI, sinusitis NONE 1
0172623 07/02/2001 PA 53.0 52 M 06/18/2001 From 8/00 to 5/01 the pt experienced fatigue, followed by extreme joint and muscle pain, flu symptoms, headaches, problems walking, and working because of pain and fatigue. 5/01 the pt started antibiotic treatment and felt a slight improvement, may be related to treatment and weather change. Y Y N 06/19/2000 08/01/2000 43 tested positive for HLADRB4 gene PVT OTH NONE 1
0172624 07/02/2001 MA 1.2 1 .2 F 12/01/2000 The pt experienced severe seizures with apnea requiring resuscitation with long periods of unresponsiveness. Intermittent speech ability after seizures. Follow upinformation received 09/23/02 states "Severe seizures with apnea requiring hospitalization, Subsequent apraxia and speech delay". The annual follow-up states "severe seizures with apnea requiring hospitalization. Subsequent apraxia and speech delay." Y Y Y 10 Y N 10/01/2000 10/02/2000 1 MRI; Cat Scan; Lumber puncture's; blood work; urine screen; EEG's; X-rays; EKG PVT PVT NKA 1
0172625 07/02/2001 VA 1.0 1 .1 F 06/18/2001 Red dot rash resembling prickly heat appeared Friday 6/15/01, with temperature of 99.F-100F. Received above immunizations 6/6/01. Fever resolved by 6/16/01. Rash fading, but still present all over body. Is recovering. Y 06/06/2001 06/15/2001 9 PUB PUB NONE NONE VA01019 1
0172626 07/02/2001 MA 1.0 F 06/20/2001 Post vax of Prevnar #2, pt's arm was sore and had a fever within 24 hours. Y PVT PUB NONE NONE 1
0172627 07/02/2001 NJ 1.0 1 .0 F 06/22/2001 On 6/1/01, the pt received the MMR, Prevnar #3 and a PPD and on 6/13/01, the pt was seen in the ER for a febrile seizure. Y Y 06/01/2001 06/13/2001 12 Blood and urine cultures-neg; CBC-ok; Na-131 MIL PVT PPD/C0141AA/ID/LA/0 previously NONE Reactive Airway Disease 1
0172628 07/02/2001 NY 1.3 1 .3 F 06/20/2001 Generalized seizure which started with staring then generalized tonic-clonic X about 13 minutes. Pt was given valium in ambulance; temperature 102F. Y Y 06/19/2001 06/19/2001 0 Cath UA; gram stain culture-positive urine culture; CT Scan; Blood culture-both neg PVT PUB NONE NONE Functional Heart Murmur 1
0172629 07/02/2001 NH 0.5 0 .5 M 06/13/2001 Severe crying/irritability Y 06/11/2001 06/12/2001 1 PVT PUB NONE 1
0172630 07/02/2001 NJ 1.0 1 .0 F 06/25/2001 Mom came to clinic and said child began with a rash "about 2 hours before (papular rash). No SOB, wheezing or swelling of face/airway. Was given Benadryl 2cc po every 6 hours and it resolved in less than 24 hours. Y 06/22/2001 06/22/2001 0 NONE PUB PUB Mantoux/Connaught/ID/0 previously; 6/12/01-Proventil Nebulizer 2.5mg NC and Orapred 1/2 tsp X 5 days NONE 6/1/01-allergic rash to Amoxil; 6/12/01-bronchitis; 6/14/01-resolving bronchitis 1
0172631 07/02/2001 MN 5.0 4 M 06/21/2001 Pt developed cellulitis in left thigh. Y Y 06/19/2001 06/20/2001 1 NONE PVT PUB NONE NONE Right shoulder dystocia, developmental delay 1
0172632 07/02/2001 NY 0.5 0 .5 M 06/22/2001 Pt awoke at 10:30 the day after receiving vaccines and cried nonstop until 13:30. He was totally inconsolable. Y 06/21/2001 06/22/2001 1 PVT PVT NONE NONE NONE 1
0172633 07/02/2001 HI 63.0 63 M 06/25/2001 Pt sweaty; local heat and cold. Per a telephone call to clinic on 6/22/01, pt developed the following symptoms. "Even slight movement of the right forearm or hand causes intense pain in the elbow and wrist. No red streaks, no fever and no history of arthritis. Dx reflex sympathetic dystrophy RUE. Treatment with Prednisone 30mg po bid X 5 days, then 1 tablet in AM and 1/2 tablet in PM X 5 days. Use Tylenol. Occupation therapy evaluation 1 X weekly. Cold packs prn. Y 05/20/2001 05/21/2001 1 PVT PVT HI0105 1
0172634 07/02/2001 NY 1.25 1 .3 M 06/25/2001 Mom called, complaining of 1 1/2" redness at injection site and swelling from shoulder to elbow on 6/22/01 to right arm after TriHibit shot. Giving Tylenol and compresses. Y 06/21/2001 06/22/2001 1 PVT PVT NONE NONE NONE 1
0172635 07/02/2001 VA 4.0 3 F 06/20/2001 Mother noted 3 1/2cm X 5cm localized reaction to left deltoid area on 6/19/01 when preparing pt for babysitter. Area reddened and warm to touch. Pt alert and oriented X 3 with no illness. Mother using cool wash cloth to area and Tylenol prn. Y 06/18/2001 06/19/2001 1 PUB PUB NONE NONE NONE 1
0172636 07/02/2001 OH 6.0 6 F 06/22/2001 On 6/14/01, pt started with dry lips (breakdown and bloody) on 6/15/01 with periorbital swelling and redness which progressed to entire face, ears/periauricular, eye canthus/cheilosis, sparred nose and forehead, denuded area on chest. Treated with prednisolone 2mg/kg tapered over 8 days. Improved to fine peel of large areas on arms, neck and face. Dx: hypersensitivity Steven's Johnson-like reaction. Y Y 06/04/2001 06/12/2001 8 NONE PVT PVT NONE NONE 9/18/00 URI and RAD with persistent cough X 8 weeks. Used Flovent and went away. 1
0172637 07/02/2001 WI 49.0 49 F 06/20/2001 On 6/12/01, pain up neck, shoulder and down left arm. On 6/19/01, red welts, swollen and painful on left arm and shoulder. No drainage, not pus filled and no itching. Pain resolved but welts still present. N 06/11/2001 06/12/2001 1 Cardiac enzymes-neg PUB PVT NONE History of shingles X 1 1
0172638 07/02/2001 MI 0.5 0 .5 M 06/15/2001 Localized erythema and induration, initially at right thigh which progressed to > 4.5cm diameter with associated warmth. Gradually resolved with warm compresses and Tylenol for comfort. Y Y 06/12/2001 06/13/2001 1 NONE PVT PVT NONE NONE NONE 1
0172639 07/02/2001 NC 36.0 36 F 06/26/2001 Pt developed a rash on anterior thighs and left hip area. U 06/14/2001 06/17/2001 3 NONE PVT PVT NONE UNK 1
0172640 07/02/2001 IL 10.0 10 M 06/26/2001 Mother called to report that child got 3-4 hives on back at injection site approx. 1 hour after getting shot. She gave the child 1 Claritin and hives were gone in 4-5 hours. Mother also reports child was very "hyper" and talkative, post vax. Y 06/25/2001 06/25/2001 0 PUB PUB NONE NONE History of anaphylactic shock to bee stings; allergies to penicillin, Augmentin, Sulfa, Cefzil nd Pediazole. 1
0172641 07/02/2001 AZ 1.5 1 .5 M 06/25/2001 Babysitter called on 6/19/01 and explained patch of little tiny pinhead size blisters grouped together and area was reddened and warm to touch. Child was brought in on Monday 6/21/01, to have TB test read and it still looked the same but not as much and still warm. The patch was > 3" X 1" and still sore. On 6/25/01, still the same. N 06/18/2001 06/19/2001 1 NONE UNK UNK Mantoux (PPD)/C0578AA/LFA/0 previously NONE Asthma; was hospitalized for RSV on 4/01. 1
0172642 07/02/2001 WV 1.6 1 .6 M Right gluteal area with macular erythema and warm to touch but not tender. Y N 06/26/2001 06/28/2001 2 PVT PUB NONE Asthmatic bronchitis 1
0172643 07/02/2001 FL 2.3 2 .4 M 06/21/2001 Impaired speech, stuttering, insecure and constantly wanting to be held. He was very independent prior to shot. Cries a lot now. A follow up report received 10/25/2002 adds: From follow-up mailed correspondence received on 08/27/2001, the pt's birth weight, number of siblings and the pt's history was provided. From follow-up correspondence received on 12/03/2001 it was reported that the pt recovered from this experience. The correct Facility Name where the vaccine was administered was also provided. This case is closed. Y 05/25/2001 05/26/2001 1 UNK UNK Teething-2 year old molars High fever and rash, 10 days, post vax.~Measles + Mumps + Rubella (no brand name)~1~1.00~In Patient 1
0172644 07/02/2001 0.3 U 04/30/2001 A physician reported that a 4 month old infant received a dose of Prevnar and presented with a fever. A lumbar puncture was done which war purulent. The culture grew out pneumococcus. Dx: Pneumococcal Meningitis. This event was considered "Medical Important". No further information was available as of the date of this report. U 12/01/2000 Lumbar Puncture-purulent. Culture revealed pneumococcus. OTH OTH UNK UNK UNK 0075224 1
0172645 07/02/2001 IL 0.75 0 .7 F 05/30/2001 A medical assistant reported that a 9 month old female received her 2nd dose of Prevnar on 3/13/01. On 3/14/01, she developed fever of 100.9F, was fussy and vomited once. On 3/30/01, she developed a cold and cough; she was irritable. On 4/6/01, she was seen by the physician and a dx of bilateral ear infections was made. The pt was treated with azithromycin. At her check-up in 4/01, her ear infections had resolved. 72 hours, prior to 4/27/01, the pt developed fever of 103.3F (ax). She was seen by the physician that day and blood cultures were drawn. The pt was prescribed ceftriaxone sodium. Her blood cultures were positive for "strep pneumonia bacteremia". As of 5/2/01, she was afebrile, still a "little" fuzzy and improving. Septicemia streptococcal is considered "Medically Important". Follow-up information received on 5/3/01, indicated that the pt experienced symptoms on 4/24/01. Blood work was performed on 4/27/01 and a culture was positive for Streptococcus pneumoniae. A dx of bacteremia was made. The pt was not hospitalized. Follow-up information received on 5/30/01, indicated that the pt was administered an injection of ceftriaxone sodium. A CBC and blood cultures were drawn. Her blood cultures were positive at 48 hours for "strep pneumonia". On 4/29/01, the pt was afebrile and acting better. She was prescribed a 10-day course of amoxicillin. Follow up 09/12/2002: "The patient subsequently recovered." Y U 03/13/2001 04/24/2001 42 Blood culture-positive for streptococcus pneumoniae; Neutrophil count: 52; White Blood Cell Count: 25,100; Lymphocyte count: 23; Haemoglobin: 12.0; Haematocrit: 35.3; Culture urine: negative; PVT PVT NONE NONE UNK HQ0472203MAY2001 1
0172648 07/02/2001 PA 0.6 0 .6 F 05/10/2001 This report was received on 3/6/01, from a healthcare professional concerning a 7 month old female pt who received her 3rd dose of Prevnar, along with IPV and Infanrix on 3/1/01. The reporter is not aware of any concomitant medication and medical history was not provided. On 3/1/01, 3 hours, post vax, the pt experienced fever as high as 103.2F (rectally), irritability, decreased appetite and increased sleep. At the time of this report, events continue. Additional information was received on 4/27/01, from the reporting healthcare professional, indicating that the pt was admitted to a hospital for 3 days for sepsis work-up. The pt developed a rash on day 5 of the fever. The fever abated, 1 day following the appearance of the rash. Blood, urine and spinal fluid cultures were obtained with negative results. The child was discharged from the hospital after 2 days of IV antibiotics. A follow-up appointment with the child's physician on 3/13/01, revealed a healthy child without sequela. Y Y 3 Y 03/01/2001 03/01/2001 0 3/13/01-Blood culture; Urine culture; CSF culture-all negative; body temperature 103.2F (rectally) PUB PUB NONE NONE UNK HQ8237309MAR2001 1
0172649 07/02/2001 NJ M 03/07/2001 An aunt reported that her nephew received Prevnar and DTP on 2/3/01. On 2/24/01, he reportedly experienced a seizure. He experienced another seizure on 3/2/01 and from that date, he experienced seizures every 2 to 3 hours. The pt was hospitalized the next day. He was treated with phenobarbital and transferred to a tertiary care facility. As of 3/5/01, the pt was still hospitalized. The reporter declined to provide additional information. Y 02/03/2001 02/24/2001 21 EEG and CT of the brain-both nml PVT OTH UNK UNK UNK HQ8018106MAR2001 1
0172650 07/02/2001 OH 1.0 1 .0 F 05/25/2001 A nurse reported that a 12 month old female received her 4th dose of Prevnar, as well as, MMRII, Comvax and Varivax on 11/22/00. The pt has a medical history of premature birth at 34 weeks gestation. On 4/22/01, at the age of 17 months, she was hospitalized for pneumococcal meningitis, serotype 19F. The pt recovered. The follow-up info received on 06/11/2001 indicated that the pt also received her first dose of MMR, her second dose of Comvax and her first dose of Varivax on 11/22/2000. She was hospitalized and blood cultures, chest x-ray and complete blood count were performed. The pt's blood cultures were positive for "Strep pneumoniae, serotype 19F" and her chest x-ray revealed a right lower lobe pneumonia. Her white blood cell count was 21.5 with lymphocytes at 25, monocytes at 14 and segmented neutrophils at 59. The pt was hospitalized for 2 days. Y 2 Y 11/22/2000 04/22/2001 151 Blood culture-positive for Strep pneumoniae, serotype 19F; X-ray-right lower lobe pneumonia; white blood cell count-21.5; lymphocyte count-25; monocyte count-14; neutrophil count-59 PVT OTH NONE nasal discharge Prematurity HQ1328225MAY2001 1
0172652 07/02/2001 GA 0.75 0 .8 F 05/23/2001 A physician reported that a 9 month old female received her second dose of Prevnar on 11/21/00. On 4/15/01, at 14 months of age, she was hospitalized due to pneumonia. An unspecified culture was performed for strain determination and was positive for "Group 19". Follow-up information received on 5/18/01, indicated that the pt was febrile for 1 week. She was hospitalized for 1 week and a blood culture was performed and it was positive for streptococcus pneumonia. The pt was administered a 10 day course of unspecified antibiotics. The pt recovered. Additional blood work included pneumococcal antibody titers performed prior to 5/16/01 (on this date her 3rd dose of Prevnar was administered) and were reported as "normal". A titer on serotype 19F was also included in this group. Follow-up information received on 5/23/01, indicated that the pt's white blood cell count was "high" for 10 days. The titer result indicated that the pneumococcus was serotype 19. Further follow-up info received on 06/05/2001 indicated tha tthe specimen was serogrouped; however, the reporter was unable to obtain the serotype of the blood culture isolate. Y 7 Y 11/21/2000 04/15/2001 145 Blood culture-positive for streptococcus pneumonia PVT PVT Augmentin Ear infection UNK HQ0570707MAY2001 1
0172654 07/02/2001 WI U 05/15/2001 A physician reported that a child, over the age of one, received Prevnar and developed a fever. The reporter indicated that other children experienced a fever following receipt of Prevnar; however, he did not provide the number of pts. Additional reports will be generated when identifying information is provided. U UNK OTH OTH UNK UNK UNK HQ9888819APR2001 1
0172655 07/02/2001 IL 1.4 1 .5 M 05/30/2001 A nurse reported that a 17 month old male received his 1st dose of Prevnar along with doses of Hib-Titer, MMR, Varivax and Tripedia on 3/1/01. The child's mother indicated that the Prevnar injection site was red and "more pronounced" compared to the other injections that the child had received. Additional information received from the reporter on 5/30/01, indicated that the child also received Hep-B vaccine on 3/1/01. The child recovered. Y 03/01/2001 UNK PVT PVT Tuberculin/PPD NONE UNK HQ9891219APR2001 1
0172656 07/02/2001 MO 1.6 1 .6 F 05/18/2001 A mother reported that her 19 month old daughter received her 2nd injection of Prevnar on 5/1/01. Approx. 6 hours, post vax, the child developed a fever of 102F and 20 to 25 episodes of diarrhea. She was treated with Advil, Tylenol and Anusol (hydrocortisone). This child developed rotavirus gastroenteritis following receipt of her 1st dose of Prevnar. See HQ1046118MAY2001. U 05/01/2001 05/01/2001 0 A fecal specimen was collected for testing; however, results were not available. OTH OTH NONE NONE UNK Rotavirus gastroenteritis~Pneumo (Prevnar)~0~0.00~In Patient HQ0636408MAY2001 1
0172657 07/02/2001 NJ M 05/23/2001 A father reported that his son received his 1st dose of Prevnar and subsequently, developed a "high" fever. No further information was available at the date of this report. U UNK OTH OTH UNK UNK UNK HQ0738310MAY2001 1
0172658 07/02/2001 WI 1.75 1 .8 M 06/27/2001 A physician reported that a 21 month old male received a dose of Prevnar and within 12 to 18 hours, post vax, he developed fever, vomiting and diarrhea. The pt recovered after 3 to 4 days. As of this date, no further information was available. The pt remained recovered. Y 02/02/2001 02/02/2001 0 UNK PVT OTH UNK UNK UNK HQ0814314MAY2001 1
0172659 07/02/2001 OH 0.3 M 05/25/2001 A physician reported that a 4 month old male received (his routine vaccinations at 4 months of age) Prevnar, diphtheria, tetanus and acellular pertussis, haemophilus influenza type B, Hep-B and IPV vaccines on 4/16/01 and later that day, developed urticaria with a few target lesions. He was seen by the physician on 4/17/01 and was treated with diphenhydramine. The pt has been referred to an allergist to "sort out allergy". As of this date, no further information was available. Y U 04/16/2001 04/16/2001 0 UNK OTH OTH UNK UNK UNK HQ0875015MAY2001 1
0172660 07/02/2001 NE 0.5 0 .5 M 05/25/2001 A nurse reported a 6 month old pt (gender not specified) received a 3rd injection of Prevnar, and Tripedia on 5/15/01. Within 12 hours, the child developed a fever of 102F-103F, fussiness and loss of appetite. At that same time, the child developed an injection site reaction characterized by redness and swelling. This is one of 3 identifiable pts from this reporter who experienced events following receipt of Prevnar (lot 474724). For information on the other 2 pts, see HQ1206422MAY2001 and HQ1206522MAY2001. The reporter was unable to specify additional pts involved. Additional reports will be generated when identifying information is provided. Y 05/15/2001 05/15/2001 0 UNK PVT OTH NONE NONE UNK HQ1115021MAY2001 1
0172661 07/02/2001 WI 1.8 1 .8 M 05/23/2001 A physician reported that a 22 month old male received a dose of Prevnar and within 12 to 18 hours following immunization, developed fever, vomiting and diarrhea. The pt recovered after 3 to 4 days. As of the date of this report, no further information was available. This is 1 of 2 reports from this facility of adverse events following receipt of Prevnar. See HQ0814314MAY2001. Y 03/01/2001 03/19/2001 18 UNK OTH OTH UNK UNK UNK Fever, vomiting and diarrhea~Pneumo (Prevnar)~~1.75~In Patient HQ1130321MAY2001 1
0172662 07/02/2001 OH 5.0 4 F 05/29/2001 A nurse reported that a 5 year old female with mild bronchitis, received her 1st dose of Prevnar on 5/15/01. On 5/16/01, she developed an injection site reaction characterized by redness and swelling that extended from her shoulder to her elbow. Y 05/15/2001 05/16/2001 1 UNK PVT PVT NONE Mild bronchitis UNK HQ1135921MAY2001 1
0172663 07/02/2001 NE 0.2 0 .2 M 05/25/2001 A nurse reported a 2 month old pt (gender not specified) received a 1st injection of Prevnar and Tripedia, IPV and Comvax on 5/16/01. Within 12 hors, the child developed a fever of 102F-103F, fussiness and loss of appetite. At that same time, the child developed an injection site reaction characterized by redness and swelling. This is one of 3 identifiable pts from this reporter who experienced events following receipt of Prevnar lot 474724. For information on the other 2 pts see HQ1115021MAY2001 and HQ1206522MAY2001. The reporter was unable to specify additional pts involved. Additional reports will be generated when identifying information is provided. Y 05/16/2001 05/16/2001 0 UNK PVT OTH NONE NONE UNK HQ1206422MAY2001 1
0172664 07/02/2001 NE 0.25 0 .2 F 05/29/2001 A nurse reported a 3 month old pt (gender not specified) received a 1st injection of Prevnar and Tripedia, IPV and Comvax on 5/16/01. Within 12 hours, the child developed a fever of 102F-103F, fussiness and loss of appetite. At that same time, the child developed an injection site reaction characterized by redness and swelling. This is 1 of 3 identifiable pts from this reporter who experienced events following receipts of Prevnar lot 474724. For information on the other 2 pts see HQ1206422MAY2001 and HQ1115021MAY2001. The reporter was unable to specify additional pts involved. Additional reports will be generated when identifying information is provided. Y 05/16/2001 05/16/2001 0 UNK PVT OTH NONE NONE UNK HQ1206522MAY2001 1
0172665 07/02/2001 CA 0.6 M 05/30/2001 A physician reported that a 7 month old male received his 3rd dose of Prevnar and subsequently, developed an injection site reaction characterized by erythema and "a lot of" swelling. No further information was available at the date of this report. This is 1 of 2 pts from this facility who experienced an adverse event following receipt of Prevnar. See HQ1366125MAY2001. U UNK OTH OTH UNK UNK UNK HQ1284524MAY2001 1
0172666 07/02/2001 MA 1.0 1 .0 F 06/01/2001 A pediatrician reported that a 12 month old female received her 4th dose of Prevnar vaccine, in the left arm, on 4/5/01. She also received Prevnar vaccine on 8/8/00 at 4 months of age, 10/13/00 at 6 months of age and 1/5/01 at 9 months of age. On 5/23/01, at 13 months of age, the child developed an injection site reaction characterized by tenderness, induration and warmth. Y U 04/05/2001 05/23/2001 48 UNK PVT OTH NONE UNK UNK HQ1352625MAY2001 1
0172667 07/02/2001 CA M 05/31/2001 A physician reported that a male pt received Prevnar and 72 hours later, developed a fever. No further information was available at the date of this report. This is 1 of 2 pts from this facility who experienced an adverse event following receipt of Prevnar. See HQ1284524MAY2001. U UNK PVT OTH UNK UNK UNK HQ1366125MAY2001 1
0172668 07/02/2001 IN 9.0 F 06/06/2001 A nurse reported that a 9 year old female developed an injection site reaction following vaccination with Prevnar (date unspecified). The child has a history of cerebral palsy and takes "many" unspecified medications. The child received other unspecified vaccinations on the day of vaccination with Prevnar. The child developed erythema (4" X 3") and swelling on the thigh at the Prevnar injection site. Benadryl (diphenhydramine hydrochloride was given and ice was placed on the injection site. Y Y 05/17/2001 05/18/2001 1 UNK PVT OTH Many "unspecified" medications UNK Cerebral Palsy HQ1368125MAY2001 1
0172670 07/02/2001 NY 1.5 1 .5 F 04/16/2001 A mother reported that her 18 month old daughter received Prevnar, poliomyelitis and DTP vaccines on 2/27/01. On 3/4/01, she developed a fever of 103F and severe diarrhea. On 3/5/01, she developed vomiting. She was treated with ibuprofen. As of 3/6/01, her symptoms persisted. U 02/27/2001 03/04/2001 5 UNK PVT PVT NONE NONE Ear infection NOS HQ8237409MAR2001 1
0172671 07/02/2001 FL 0.75 0 .7 F 04/23/2001 A mother reported that her 9 month daughter received Prevnar and Hep-B vaccines on 3/1/01. A few hours, post vax, she developed crankiness, a decreased appetite and was sleeping more than usual. On 3/8/01, the crankiness was better, however; she was still sleeping more and eating less than she normally does. U 03/01/2001 03/01/2001 0 UNK PVT OTH Fluoride NONE UNK HQ8245309MAR2001 1
0172672 07/02/2001 MA 0.75 0 .8 F 04/23/2001 A physician reported that a 9 month old female received Prevnar and Hep-B vaccines on 12/20/00 and subsequently, developed a fever, vomiting and redness at an unspecified injection site. The fever and vomiting resolved the next day. The injection site reaction resolved within 48 hours. Y 12/20/2000 UNK PUB PUB NONE UNK UNK HQ8245409MAR2001 1
0172673 07/02/2001 OH 0.8 F 05/14/2001 A physician reported that a 10 month old female received Prevnar and within 24 hours, post vax, developed a fever of 102F to 103F and an injection site reaction characterized by a 3cm to 4cm area of redness and induration. The infant was taken to the ER for further evaluation. No further information was available at the date of this report. The reporter indicated that 4 pts experienced this event following receipt of Prevnar lot 475383; however, 3 are not presently identifiable. Additional reports will be generated when identifying information is provided. Y U UNK PVT PUB UNK NONE UNK HQ8336113MAR2001 1
0172674 07/02/2001 IL 0.75 0 .7 U 04/18/2001 A nurse reported that an 8 month old infant received an injection of Prevnar on 3/5/01. On 3/6/01, the infant developed a fever of 102F. The infant was treated with acetaminophen and recovered. Y 03/05/2001 03/06/2001 1 UNK PVT OTH NONE NONE UNK HQ8340413MAR2001 1
0172675 07/02/2001 LA 0.6 M 04/18/2001 A territory representative reported that a 7 month old male received his 1st dose of Prevnar in 3/01. Five days, post vax, he developed generalized urticaria. On 3/13/01, he was seen by the physician and treated "symptomatically". No further information was available at the date of this report. Y U 03/01/2001 03/06/2001 5 UNK PUB OTH UNK UNK UNK HQ8397214MAR2001 1
0172676 07/02/2001 MI 0.2 M 04/19/2001 After vaccinations on 03/04/2000 the pt developed hive on his face on 03/09/2001. He was treated with diphenhydramine. U 03/04/2001 03/09/2001 5 UNK PVT OTH UNK NONE UNK HQ8516545MAR2001 1
0172677 07/02/2001 0.3 M 05/14/2001 The father reports after receiving vaccinations his son developed vomiting, injection site redness and experienced irritability. The father indicated that all sx resolved within 2 or 3 days. Y 03/01/2001 03/01/2001 0 UNK UNK UNK UNK UNK UNK injection site mass~DTaP (no brand name)~~0.00~In Patient HQ8586619MAR2001 1
0172678 07/02/2001 LA 0.5 0 .6 F 05/14/2001 2 days after being vaccinated, the pt developed a fever, wheezing, and injection site reaction that looked like necrosis at an unspecified site. Y Y 03/07/2001 03/09/2001 2 UNK PVT OTH NONE NONE UNK HQ8688421MAR2001 1
0172679 07/02/2001 NC 0.5 0 .5 F 05/09/2001 One day after being vaccinated the pt developed a 1 cm-1.5 cm area of induration at the site of the Prevnar injection. She also developed a streak of erythema that extended from the area of induration. Y 03/19/2001 03/20/2001 1 UNK MIL PUB NONE Diarrhea UNK HQ8688321MAR2001 1
0172680 07/02/2001 MN 1.0 F 05/14/2001 One day after vaccinations, the pt's mother reported that her daughter developed hives at the injection site. U 03/22/2001 03/23/2001 1 UNK UNK UNK UNK UNK UNK HQ8844826MAR2001 1
0172681 07/02/2001 OH 0.6 0 .6 M 05/14/2001 Thirty six hours post immunization the pt developed urticaria in the form of welts and swollen area. Y 03/21/2001 03/23/2001 2 UNK PVT OTH NONE NONE UNK HQ8904227MAR2001 1
0172682 07/02/2001 FL U 05/31/2001 After receiving a an injection of Prevnar the pt developed an injection site reaction with redness and hardness. The reporter stated that the reaction sometimes lasted for 3 weeks U UNK PUB OTH UNK UNK UNK HQ8910727MAR2001 1
0172683 07/02/2001 FL 2.6 2 .6 F 05/18/2001 A physician's assistant reported that after receiving her first dose of Prevnar, that evening the child developed a fever of 101.8 F., irritability, and vomiting. U 03/27/2001 03/27/2001 0 UNK PUB OTH Penicillin UNK UNK HQ9022529MAR2001 1
0172684 07/02/2001 MO 2.0 2 .0 F 05/06/2001 A 2 yr old on the following day of receiving a second dose of Prevnar, developed an injection site rxn with redness and swelling and it appeared puffy. U 03/27/2001 03/28/2001 1 UNK OTH PUB UNK UNK UNK HQ9138202ApR2001 1
0172685 07/02/2001 F 05/14/2001 A pt who has a medical history of common variable immunodeficiency and has been treated with intravenous immunoglobulin received her first 2 injections of Prevnar and reportedly, has not had any antibody response. The mother indicated that her daughter's post-vaccination numbers were lower than her pre-vaccinations numbers. The mother also reported that her daughter received Pneumovax following immunization with Prevnar and still has no antibody response U UNK OTH OTH UNK UNK Immunodeficiency nos HQ9325502APR2001 1
0172686 07/02/2001 8.0 M 05/09/2001 A Dr reported that an 8 yr old received an injection of Prevnar and developed a very nice local rxn U UNK OTH OTH UNK UNK UNK HQ9326205APR2001 1
0172687 07/02/2001 CA 0.3 0 .4 M 05/14/2001 A father reported that his son received his first dose of Prevnar and his second dose of DTaP on 03/22/2001. Within hours the infant developed a rash on his face which spread to his neck. The reporter indicated that the infant received 2 other vaccines, however they were not identified. U 03/22/2001 03/22/2001 0 UNK PVT PVT NONE NONE UNK HQ9458509APR2001 1
0172688 07/02/2001 GA U 04/10/2001 A pharmacist reported that a 2 to 4 month old infant received Prevnar and subsequently developed a fever of 102 degrees F. The infant was treated symptomatically. This is 1 of 5 pt from this facility who developed an adverse experience following receipt of Prevnar. U UNK OTH OTH UNK UNK UNK 489410 1
0172689 07/02/2001 GA U 04/10/2001 Pharmacist reported that a 2-4 mo old infant developed a fever of 104 post vax. Pt taken to ER where a diagnosis of otitis media was made. This is 1 of 5 pts from this facility who developed an adverse experience following receipt of Prevnar. Y U UNK OTH OTH UNK UNK UNK HQ9496310APR2001 1
0172690 07/02/2001 GA 1.25 U 04/10/2001 A pharmacist reported that pt developed a "significant" local reaction post vax. This is 1 of 5 pts from this facility who developed an adverse experience following receipt of Prevnar. U UNK OTH OTH UNK UNK UNK HQ9496510APR2001 1
0172691 07/02/2001 GA 1.25 U 04/10/2001 A pharmacist reported that pt developed a "significant" local reaction post vax. The reporter noted that the reaction looked as though it was possibly cellulitis. This is 1 of 5 pts from this facility who developed an adverse experience following receipt of Prevnar. U UNK OTH OTH UNK UNK UNK HQ9496610APR2001 1
0172692 07/02/2001 NY 1.2 1 .2 M 04/12/2001 Pt had a recent history of ear infection when on 4/4/01, 2 days post vax, he experienced a seizure and developed a fever of 103. He was taken to the ER. He was not admitted to the hospital according to ER note because the pt was older than 1 year and they felt he experienced a febrile seizure. He was treated with acetaminophen and discharged. Y U 04/02/2001 04/04/2001 2 WBC-15,000; CBC and electrolytes pending OTH OTH NONE UNK ear infection HQ9584411APR2001 1
0172693 07/02/2001 SC U 05/09/2001 Nurse reported that pt developed a knot at injection site. No further info was available at the date of this report. The reporter submitted this report directly to VAERS. Manufacturer's comment: The reporter indicated that approximately 20 pts experienced this event; however, they are not presently identifiable. Addtl rpts will be generated when identifying info is provided. U UNK OTH OTH UNK UNK UNK HQ9757517APR2001 1
0172694 07/02/2001 CA 2.0 2 .6 F 05/09/2001 Two days post vax, pt developed an injection site reaction measuring 7cm by 7cm and characterized by induration and erythema. U 04/11/2001 04/13/2001 2 UNK PVT OTH NONE UNK UNK HQ9762217APR2001 1
0172695 07/02/2001 NY 1.3 1 .3 F 05/15/2001 Within 24 hrs post vax, pt developed a fever of 104. A copy of this report has been forwarded to Merck, manufacturer of MMRII. U 02/15/2001 02/15/2001 0 UNK PVT OTH NONE UNK UNK HQ9818718APR2001 1
0172697 07/02/2001 VT F 08/17/2001 Pt became irritable and restless post vax. Pt's mother had a history of latex allergy. No further info was available at the time of this report. Pt experienced restlessness and irritability following second dose of Prevnar. See HQ1482831MAY2001. Y UNK OTH OTH UNK UNK UNK HQ1354925MAY2001 1
0172698 07/02/2001 IL U 05/31/2001 A nurse reported that 4 pt's experienced hoarse voice or cry a few days post vax. No further information was available at the time of this report. Additional cases will be created upon receipt of individual pt specific information. A follow up report received 10/25/2001 adds: Follow-up info received on 08/03/2001 frmo the Center for Biologics Evaluation and Research (VAERS ID #172698) revealed the patients also received DTaP (manufacturer unknown) vaccine. U UNK OTH OTH UNK UNK UNK HQ1439330MAY2001 1
0172699 07/02/2001 VT F 08/17/2001 Pt became irritable and restless following second dose of Prevnar. Pt's mother had a history of latex allergy. No further info was available at the time of this report. Follow-up stattes a nurse reported via a company representative that her daughter became irritable and restless following her second dose of Prevnar. The child's mother had a history of latex allergy. Info from the child's physician revealed the child also received DTaP, HIB, and IPV vaccines that same day. The child has since recovered. Y UNK PVT OTH UNK NONE UNK restlessness, irritability~Pneumo (Prevnar)~1~0.00~In Patient HQ1482831MAY2001 1
0172700 07/02/2001 OR U 06/01/2001 Rash. a company representative reported that a pt received Prevnar and within 24 hrs developed an itchy rash. No further information was available at the date of this report. This is on of two pt from the facility who experienced an event following receipt of Prevnar. See related case number HQ1288324MAY2001. U OTH OTH UNKNOWN UNKNOWN UNKNOWN HQ1486231MAY2001 1
0172702 07/02/2001 NE 0.3 0 .3 M 04/09/2001 Hives. A healthcare professional reported that a 4 month old male received Prevnar, IPV, Tripedia, and Pedvax HIB, on 2/27/01. The infant was also received Amoxicillin concomitantly for a respiratory infection. One day following vaccination the infant developed an erythematous nodule about the size of a dime at the site of injection, hives on his right and left thigh, and left wrist redness. It was noted that the wrist redness may have been caused by the child sucking on his wrist. Treatment with Atarax syrup was prescribed. U 02/27/2001 02/28/2001 1 UNKNOWN PUB PUB Amoxicillin respiratory infection Concurrent conditions: upper respiratory tract infection NOS HQ8035406MAR2001 1
0172703 07/02/2001 TN 3.0 3 M 04/16/2001 Injection site reaction. A physician reported that a 3 yr old male received 1st dose of Prevnar 2/26/01 he developed a rash 5cm by 6cm in area at the injection site. The rash was red in the middle surrounded by a raised red ring. The physician stated the rash resembled ring worm. the child was treated with diphenydramine. He recovered 3/5/01. Y 02/26/2001 02/28/2001 2 UNKNOWN PVT PVT NONE NONE UNKNOWN HQ8170508MAR2001 1
0172704 07/02/2001 FL 0.7 0 .7 M 05/15/2001 Urticaria. A physician reported that pt received Prevnar, Tripedia, and IPV vaccines and subsequently developed urticaria swelling. The onset of the adverse event was 1 hr post immunization. He recovered. Y 02/27/2001 02/27/2001 0 UNK UNK HQ8176108MAR2001 1
0172705 07/02/2001 TX 2.0 2 .2 F 05/03/2001 Vomiting. A mother reported that her child received Prevnar and PPD on 3/8/01. That same day she developed vomiting and did not want to eat or drink anything. On 3/9/01 the vomiting resolved but the child developed a runny nose. Y 03/08/2001 03/08/2001 0 UNKNOWN PVT OTH NONE NONE UNKNOWN HQ8340813MAR2001 1
0172706 07/02/2001 MN 0.75 0 .8 M 05/01/2001 Pyrexia. A nurse reported that a pt received 3rd injection of Prevnar on 3/8/01. Following vaccination the child developed a fever, generalized rash and decreased appetite. The generalized rash appeared on approximately the 4th day following vaccination. The fever lasted 3-4 days. U 03/08/2001 UNKNOWN PVT PVT Mantoux NONE UNKNOWN HQ8382114MAR2001 1
0172709 07/02/2001 IA 0.4 0 .5 F 05/15/2001 Screaming. A nurse reported a pt received Prevnar and IPOL on 3/5/01. The reporter indicated that Prevnar was administered as a split dose. That same day, the infant developed crying and irritability. The crying and irritability resolved in 24 hrs. On 3/7/01 she was screaming for several hrs. A copy of this report has been forwarded to Aventis Pasteur, manufacturer of IPOL. Y 03/05/2001 03/07/2001 2 UNKNOWN PVT PVT Acetaminophen NONE UNKNOWN HQ8514716MAR2001 1
0172710 07/02/2001 IN 1.5 1 .5 F 04/24/2001 Rash erythematous. A nurse reported that a pt with a recent history of fever received her 1st dose of Prevnar on 3/20/01, within 24 hrs post immunization, she developed a generalized light red rash over her body. This is 1 of 2 patients from this facility who had an adverse event following receipt of Prevnar lot 474-946. U 03/20/2001 03/21/2001 1 UNKNOWN PVT OTH NONE UNKNOWN Past condition: pyrexia HQ8866326MAR2001 1
0172711 07/02/2001 LA 1.5 1 .6 M 05/14/2001 Fever. A pharmacist reported that her son received injection of Prevnar on 3/21/01. Within 24 hrs of vaccine the child developed irritability and a fever of 101F to 102F. He also developed trouble walking and bending down. The mother treated the child with advil . This is 1 of 2 pt from this facility who had an adverse experience following receipt of Prevnar. U 03/21/2001 03/21/2001 0 UNKNOWN PVT PVT NONE NONE UNKNOWN ~Pneumo (Prevnar)~~0.00~In Sibling HQ8866526MAR2001 1
0172712 07/02/2001 NY 0.25 0 .3 M 05/31/2001 Respiratory disorder. A nsg reported a pt with medical history of possible latex allergy, received his 1st doses of Prevnar, Hib-TITER, IPOL and DTaP vaccines on 1/21/01. On 3/19/01, when he was 5 months old the infant's mother reported to the pediatrician that the infant developed respiratory difficulty, wheezing and oral thrush. A copy of this report has been forwarded to Aventis Pasteur. U 01/24/2001 01/24/2001 0 UNKNOWN PVT OTH Synthroid NONE Concurrent conditions: Hypersensitivity NOS 897052 1
0172713 07/02/2001 CT 0.5 0 .5 M 04/18/2001 Rash erythematous. A physician reports that a pt received 2nd dose of Prevnar and Engerix B vaccines on 3/23/01, within 12 hrs post IZ he developed a generalized erythematous rash, irritability, sleeplessness, and a decreased appetite. The reporter indicated that the pt did not sleep for 3 nights. A copy of this report has been forwarded to SKB. U 03/23/2001 03/23/2001 0 UNKNOWN PVT PVT NONE NONE UNKNOWN HQ9092130MAR2001 1
0172714 07/02/2001 TX 0.8 0 .9 U 05/14/2001 Influenza like illness. A mother reported that her child received the 1st Prevnar on 3/27/01 and within 1 hr developed flu-like symptoms described as fever between 102F and 103F, stuffy nose, green drainage, nausea, earache, sore throat and coughing. The child's mother, father, and 2 year old sibling(who did not receive Prevnar) also developed these symptoms within 1 hr following the 10 month old's IZ. This is 1 of 2 reports from this family following the 10 month old's receipt of Prevnar. U 03/27/2001 03/27/2001 0 UNKNOWN PVT OTH NONE NONE UNKNOWN HQ9140502APR2001 1
0172715 07/02/2001 TX 2.0 2 1 M 05/31/2001 Injection site reaction. A mother reported that her child received 1st dose of Prevnar on 3/28/01. Within 24 hrs the child developed an injection site reaction characterized by swelling and redness of the entire thigh and he experienced difficulty in walking. The child was treated with benadryl and the application of ice packs, he was recovering. Additional information received from the physician on 5/22/01, indicated that the child recovered. Y 03/28/2001 03/28/2001 0 UNKNOWN PVT PVT Singulair UNKNOWN Concurrent conditions: Asthma NOS, Bronchospasm NOS HQ9146802APR2001 1
0172716 07/02/2001 CA 2.25 2 .3 M 07/13/2001 Gait disturbance. a mother reported that her child received 1st dose of Prevnar on 3/29/01. Within 3 hrs the child developed a limp in the leg in which Prevnar was administered. Follow-up info was received from the physician on 06/25/2001. The reporter indicated that the child developed slight swelling at the injection site. He recovered approximately 3 days later. Y 03/29/2001 03/29/2001 0 NONE PVT PUB Tylenol UNKNOWN UNKNOWN HQ9148502APR2001 1
0172717 07/02/2001 PA 1.5 1 .5 M 05/15/2001 Fever. A grandmother reported that her grandson received his 2nd Prevnar on 3/29/01, approximately 6 hrs post immunization, he developed a fever of 101F. He later developed hives and swelling in his calves and legs, The reporter thinks the swelling is a result of scratching. U 03/29/2001 03/29/2001 0 UNKNOWN PVT PVT NONE NONE UNKNOWN HQ9234103APR2001 1
0172718 07/02/2001 AL 1.5 1 .5 M 07/18/2001 Fever. A mother reported that her son received injection of Prevnar on 1/24/01. Subsequently, the child developed a fever of 101F, irritability and limb restrictions. He recovered. Follow-up info received from the phsyician on 07/17/2001 indicated tha the child received an injection of Prevnar on 01/22/2001. Y 01/22/2001 UNKNOWN PVT OTH NONE NONE UNK HQ9464409APR2001 1
0172719 07/02/2001 NC 0.3 0 .4 M 05/14/2001 Bronchiolitis. A mother reported that her child received 2nd Prevnar, Haemophilus B conjugate, DTaP and poliomyelitis virus vaccine administration the infant developed wheezing, irritability, weepy eyes and a runny nose. The mother reported that the infant was diagnosed with bronchiolitis and an ear infection. He was treated with Albuterol and Amoxicillin. The wheezing resolved by 1/21/01. The infant recovered fully from bronchiolitis. Follow-up info received from the physician on 06/08/2001, indicated tha the infant was seen by the physician on 01/20/2001 with bronchiolitis, wheezing, and otitis media. The physician stated that at the time the child was immunized, "bronchiolitis was epidemic in the community," and that she "did not believe his illness was an adverse reaction to Prevnar." Y Y 01/12/2001 01/19/2001 7 UNK PVT PVT NONE UNK UNK HQ9464509APR2001 1
0172720 07/02/2001 IN 2.9 2 .9 M 07/05/2001 Transient Blindness. A territory representative reported that a pt received an injection on Prevnar on 4/5/01. Approximately 3 hrs post vaccine the child developed a headache, sensitivity to light and couldn't see. He recovered about 1.5 hrs later that same day. Follow-up info received from the physician on 06/08/2001 indicated that the child was seen by the physician. Y Y 04/05/2001 04/05/2001 0 UNK PVT OTH NONE NONE UNK HQ9475110APR2001 1
0172721 07/02/2001 GA U 04/11/2001 Serum sickness. An infant received an injection of Prevnar. The infant developed a fever of 102F and was treated or serum sickness with Amoxicillin/potassium clavulanate. This is 1 of 5 pt from this facility who developed an adverse experience following receipt of Prevnar. U UNKNOWN OTH OTH UNKNOWN UNKNOWN UNKNOWN HQ9496210APR2001 1
0172722 07/02/2001 AZ 1.0 1 .0 M 05/15/2001 Maculopapular rash. A nsg reported that a pt received Prevnar, DTaP, and Hib vaccines on 3/29/01, within 24 hrs post vaccines he developed a maculopapular rash that extended from his R deltoid to his R elbow all the way around the arm. Prevnar was injected into the R deltoid. As of 4/10/01 the rash persisted. U 03/29/2001 03/30/2001 1 UNKNOWN OTH OTH NONE NONE Past conditions: Imperforated anus. HQ9588211APR2001 1
0172724 07/02/2001 IN 1.7 1 .7 F 04/25/2001 Abdominal pain. A nsg reported that a 20 month old received Prevnar and Acel-Imune vaccines on 3/21/01. That evening she developed intermittent abdominal pains. As of 3/23/01, the abdominal pains persisted. This is 1 of 2 pt from this facility who had an adverse experience following receipt of Prevnar lot 474-946. Y U 03/21/2001 03/21/2001 0 UNKNOWN PVT OTH NONE NONE UNKNOWN HQ9976220APR2001 1
0172725 07/02/2001 OH 0.3 M 05/14/2001 Hives. A physician reported via a Co representative that a infant received Prevnar, Hib-Titer, DTaP, and IPV, and hepatitis B vaccines on the same date in 4/01 and subsequently developed generalized hives over his body. Follow-up information received from the physician on 09-JUL-2001 indicated that unspecified skin testing was performed on 13-JUN-2001, and the patient was determinedd to be allergic to the pertussis component of the DTaP vaccine. U 04/01/2001 04/01/2001 0 Skin test, 06/13/2001, patient allergic to the pertussis component of DTaP vaccine; PVT OTH Unknown Unknown Ukn HQ0009323APR2001 1
0172726 07/02/2001 CA 1.5 U 05/01/2001 Urticaria NOS. A physician reported that an infant received the 1st dose of Prevnar along with DTaP/Hib combination and immediately developed hives. U UNKNOWN OTH OTH UNKNOWN UNKNOWN UNKNOWN 006624 1
0172727 07/02/2001 AL 1.7 U 05/14/2001 Fever. A physician reported via a territory representative that a child received Prevnar and subsequently developed a fever of 104.9F. No further information was available at the date of this report. This is 1 of 2 patients from this facility who developed a fever following receipt of Prevnar. U UNKNOWN PVT OTH UNKNOWN UNKNOWN UNKNOWN HQ0119225APR2001 1
0172728 07/02/2001 FL 2.8 2 .8 F 05/29/2001 Injection site reaction. A nsg reported that a child received Prevnar on 4/10/01, she developed an injection site reaction characterized by a large hard, reddened area. She was treated with cold compresses. She recovered. Additional information received from the physician on 5/22/01 indicated that no other vaccines were given within 4 weeks of Prevnar administration. Y 04/10/2001 04/12/2001 2 UNKNOWN PUB PUB UNKNOWN NONE UNKNOWN HQ0174226APR2001 1
0172729 07/02/2001 CA U 05/14/2001 Injection site edema. A physician reported that an unidentified child received Prevnar vaccine and subsequently developed swelling at the injection site. No further information was available as of the date of this report. This report was received via Merck & Co, Inc. U UNKNOWN OTH OTH UNK UNK UNK HQ0202426APR2001 1
0172730 07/02/2001 U 05/04/2001 Fever. A nsg reported that a child received an injection of Prevnar and subsequently developed a fever of 103F. No further information was available at the date of this report. U UNKNOWN OTH OTH UNKNOWN UNKNOWN UNKNOWN HQ0222227APR2001 1
0172731 07/02/2001 MD 1.0 1 .0 F 05/09/2001 Injection site reaction. A physician reported that an infant received her 2nd dose of Prevnar along with her 1st dose of Varicella on 4/16/01. Nine days later the child developed an injection site reaction at the Prevnar site, characterized by redness, warmth and hardness. U 04/16/2001 04/25/2001 9 UNKNOWN PVT PVT NONE NONE UNKNOWN 027083 1
0172733 07/02/2001 CO U 05/04/2001 Injection site mass. A medical assistant reported that a patient received an injection of Prevnar and subsequently developed a lump at the injection site. No further information was available at the date of this report. Manufacturer's comment: The reporter indicated that 6-7 pt experienced this event' however they are not presently identifiable. Additional reports will be generated when identifying information is provided. U UNKNOWN PVT OTH UNKNOWN UNKNOWN UNKNOWN HQ0472303MAY2001 1
0172734 07/02/2001 AL 1.5 1 .5 F 05/09/2001 Injection site reaction. A nsg reported that a child received Prevnar, TriHibit, hepatitis B and IPV vaccines on 4/30/01. The following day the child developed an injection site reaction characterized by redness, warmth, and swelling. The specific sites on vaccine administration were not reported. She was also fussy. The child was seen in an ER where they marked the area of reaction. On 5/2/01 she was seen by the physician because the redness had spread outside the markings. A copy of this report has been forwarded to Aventis Pasteur, manufacturer of TriHibit and IPV. Y U 04/30/2001 05/01/2001 1 UNKNOWN PVT OTH NONE NONE UNKNOWN HQ0498504MAY2001 1
0172735 07/02/2001 AL U 05/17/2001 Fever. A physician reported via a territory representative that a child received Prevnar and subsequently developed a fever of 104.3F. No further information was available at the date of this report. This is 1 of 2 pt's from this facility who developed a fever following receipt of Prevnar. U UNKNOWN PVT OTH UNKNOWN UNKNOWN UNKNOWN HQ0574707MAY2001 1
0172736 07/02/2001 CT 0.5 0 .5 F 05/30/2001 Diarrhea. A nsg practitioner reported that an infant received her 2nd Prevnar on 10/18/00. Medical history includes sickness. On 10/23/00, the infant developed diarrhea for 4 days. She recovered. Y 10/18/2000 10/23/2000 5 UNKNOWN PVT OTH UNKNOWN UNKNOWN Past conditions: sickness sickness/upper respiratory infection/sinusitis/fever, rhinorrhea~Pneumo (Prevnar)~1~0.00~In Patient HQ0636208MAY2001 1
0172737 07/02/2001 LA 1.5 1 .6 M 08/07/2001 Fever. A pharmacist reported that her 18month old child received an injection of Prevnar on 3/21/01. Approximately 2-3 hrs post vaccine. The child developed a fever of 101 - 102F and irritability. He also developed 2 raised red spots on his face that are the size of a dime. The mother is treating him with Benadryl, Advil and an unspecified corticosteroid. This is 1 of 2 pt from this facility who had an adverse experience following receipt of Prevnar. Follow-up info received on 07/30/2001 from the physician indicated that the child recovered. Y 03/21/2001 03/21/2001 0 UNK PVT PVT NONE NONE UNKNOWN HQ0482103MAY2001 1
0172738 07/02/2001 WI 0.75 0 .8 F 05/14/2001 Rash erythematous. A nsg reported that an infant received her 2nd injection of Prevnar on 4/30/01. On 5/4/01 she developed an overall body rash described as little red bumps all over her body. U 04/30/2001 05/04/2001 4 UNKNOWN PVT OTH NONE UNKNOWN UNKNOWN rash~Pneumo (Prevnar)~1~0.00~In Patient HQ0524304MAY2001 1
0172739 07/02/2001 IL M 05/29/2001 Injection site urticaria. a physician reported that a child received an injection of Prevnar and subsequently developed a red welt at the injection site. Additional information received from the physician on 5/22/01 indicated that the child was a 2 yr old male. He recovered. Y UNKNOWN OTH OTH UNKNOWN UNKNOWN UNKNOWN HQ0526604MAY2001 1
0172740 07/02/2001 TX 4.0 4 U 05/14/2001 Influenza like illness. A mother reported that her child received the 1st Prevnar, as well as Haemophilus influenza type B, MMRII, and IPV on 3/27/01 and within 1 hr, developed flu like symptoms described as fever between 102 - 103F, stuffy nose, green drainage, nausea, earache, sore throat and coughing. The child's mother, father and 2 yr old sibling who did not receive Prevnar also developed these symptoms within an hour of the 4 yr old's receipt of Prevnar. This is 1 of 2 reports form this family following the 4 yr old's receipt of Prevnar. A copy of this report has been forwarded to Merck & Aventis Pasteur, manufactures of the concomitantly administered vaccines. U 03/27/2001 03/27/2001 0 UNKNOWN PVT OTH Tuberculin, protein purified derivative PPD NONE UNKNOWN ~Pneumo (Prevnar)~~0.00~In Sibling HQ0588407MAY2001 1
0172741 07/02/2001 WI 0.6 0 .6 F 05/14/2001 Rash erythematous. A nsg reported that an infant received her 1st injection of Prevnar in 3/01. Approximately 4 days post vaccination the infant developed an overall body rash described as little red bumps all over the body. U 03/01/2001 03/05/2001 4 UNKNOWN PVT OTH UNKNOWN UNKNOWN UNKNOWN Red rash~Pneumo (Prevnar)~1~0.00~In Patient HQ0616308MAY2001 1
0172742 07/02/2001 CT 0.3 0 .4 F 05/15/2001 Sickness. A nsg practitioner reported that an infant received her 1st Prevnar on 8/16/00. On 9/5/00 the mother called the Hlth care provider office and stated that her infant was sick. U 08/16/2000 09/05/2000 20 UNKNOWN PVT OTH UNKNOWN UNKNOWN UNKNOWN diarrhea, upper respiratory infection, sinusitis, fever~Pneumo (Prevnar)~2~0.00~In Patient HQ0636108MAY2001 1
0172743 07/02/2001 CT 0.75 0 .8 F 05/15/2001 Sinusitis. A nsg practitioner reported that a 9month old infant received her 3rd Prevnar vaccine as well as hepatitis B on 1/18/01. Medical history includes diarrhea and sickness. On 2/13/01 the infant developed sinusitis and an upper respiratory infection. she was treated with Amoxicillin. U 01/18/2001 02/13/2001 26 UNKNOWN PVT OTH UNKNOWN UNKNOWN Past condition: diarrhoea NOS, sickness Sickenss, diarrhea, fever and rhinorrhea, ear infection and conjunctivitis~Pneumo (Prevnar)~1~0.00~In Patient HQ0636308MAY2001 1
0172744 07/02/2001 MI M 05/23/2001 Respiratory disorder. A territory representative reported that a male patient, with a history of asthma, received an injection of Prevnar. Subsequently he developed a fever and the need for extensive breathing treatments. No further information was available at the date of this report. U UNKNOWN PVT OTH UNKNOWN UNKNOWN Concurrent condition: asthma NOS HQ0780311MAY2001 1
0172745 07/02/2001 TX 0.2 0 .2 M 05/15/2001 Neck stiffness. A nsg reported that an infant received his 1st Prevnar along with doses of Tripedia, Act-HIB, and IPOL vaccines on 5/2/01. 4 hrs post immunization the infant developed neck stiffness, described as the infant's head leaning to one side. The next day, he was seen in the ER. A lumbar puncture was performed, the result was clear. The reporter indicated that the infant refuses breast milk but will take a bottle. The physician suspects possible torticollis. Follow-up info received from the vaccine provider on 07/17/2001 indicated that the infant was evaluated by an MRI; no results werre found. The infant's symptoms improved over the next 4 to 6 weeks. On 07/09/2001, the physician stated that the infant received Prevnar, OPOL HIB and DTaP vaccines with no symptoms or adverse effects. The reporter also provided lot numbers for the concomitantly administered vaccines. Y Y 05/02/2001 05/02/2001 0 5/3/01 Lumbar puncture - clear PVT PVT NONE NONE UNK HQ0832414MAY2001 1
0172746 07/02/2001 OH 0.6 0 .6 F 06/19/2001 Vasculitis rash. A physician reported an infant received her 2nd injection of Prevnar in the R thigh and 3rd injection of Tripedia in the L thigh on 4/18/01. Three days later on 4/21/01 the child developed a vasculitis like rash on the right lower leg and ankle. Y 04/18/2001 04/21/2001 3 UNK PVT PUB NONE Otitis media Otitis media NOS HQ0976717MAY2001 1
0172747 07/02/2001 MN 1.09 1 .1 M 06/06/2001 Information has been received from a physician concerning a pt who was vaccinated with PREVNAR, VARIVAX, and COMVAX on4/25/01. On 4/30/01 5 days later, the infant developed a nodule (less than 2.4cm) at the PREVNAR injection site on the R thigh. On 5/2/01, he was vaccinated with IPV in the R thigh, and MMR and DTaP in the L thigh. One week later (2 weeks post PREVNAR vaccination) the infant developed lymphadenopathy at the inguinal region, tenderness and swelling. U 04/25/2001 05/09/2001 14 UNKNOWN OTH OTH NONE NONE UNKNOWN HQ0978417MAY2001 1
0172748 07/02/2001 MI 1 .4 F 05/18/2001 Gastroenteritis Rotavirus. A mother reported her child received her 1st dose of Prevnar on 2/22/01. Subsequently, she developed diarrhea. a stool sample was positive for rotavirus. No further information was available at the date of this report. This pt developed a fever and diarrhea following receipt of her second dose of Prevnar. U 02/22/2001 02/22/2001 0 Culture Stool/positive for rotavirus OTH OTH UNKNOWN UNKNOWN UNKNOWN Fever, diarrhear~Pneumo (Prevnar)~1~0.00~In Patient 01046118 1
0172749 07/02/2001 OH U 06/01/2001 Flushing. A company representative reported that a child received Prevnar and within 1 hr of vaccine administration, developed flushing of the neck and back. No further information was available at the date of this report. This is on of two pt's from this facility who experienced an event following receipt of Prevnar. U UNKNOWN OTH OTH UNKNOWN UNKNOWN UNKNOWN HQ1288324MAY2001 1
0172750 07/02/2001 MI 8.0 8 M 06/06/2001 Obsessive-compulsive disorder. A mother reported that her child who has a history of OCD trends and tics received his 1st dose of Prevnar on 4/18/01. Soon after vaccination he experienced an exacerbation of his OCD trends and tics. U 04/18/2001 UNKNOWN PVT OTH Penicillin NOS NONE Concurrent conditions: autoimmune disorder NOS; obsessive-compulsive disorder; Tic; pneumonia NOS HQ1288524MAY2001 1
0172751 07/02/2001 CT 1.0 1 .0 F 06/01/2001 Pyrexia. a nsg practitioner reported that an infant received her 4th dose of Prevnar, as well as DTaP, IPV, Haemophilus B Conjugate, MMR, and Varivax vaccines on 4/16/01. Medical history includes diarrhea, sinusitis, and upper respiratory infection. On 4/17/01 the child developed fever and thick green drainage. Y U 04/16/2001 04/17/2001 1 UNKNOWN PVT OTH NONE NONE Past conditions: diarrhoea NOS, sinusitis NOS, upper respiratory tract Sickness,diarrhea,URI~Pneumo (Prevnar)~1~0.00~In Patient HQ0121025APR2001 1
0172752 07/02/2001 OR 4.0 4 F 05/31/2001 The day of receiving vax pt developed a "significant" local reaction characterized by swelling, redness, itching, and hives at the Prevnar injection site. Pt was treated with Benadryl and Keflex 250 mg tid for 10 days for possible cellulitis. The pt recovered. Y 04/18/2001 04/18/2001 0 NONE OTH OTH UNK NONE UNK HQ0122525APR2001 1
0172753 07/02/2001 TX 3.0 4 M 06/19/2001 Pt awoke from nap on day of receiving vax screaming that his left ear was hurting. The health care provider treated him with "drops" and oral antibiotics (not specified). Later that evening child again complained of ear pain and was seen in the ER. He was given a diagnosis of "mild" pharyngitis. The following day he was seen by his health care provider with no signs of ear pain and was found to be "fine." He recovered. Y Y 04/24/2001 04/24/2001 0 UNK PVT PVT UNK NONE UNK HQ0232127APR2001 1
0172754 07/02/2001 MO 6.0 6 M 05/14/2001 At the time of vax, pt had tiny raised clear blisters on his wrist. A few days post vax, he experienced aching knee joints and then a stomach "virus." On 4/19/01, he developed "huge" hives. He was treated with Pedipred but the hives persisted. Concomitant therapy included Singulair, Claritin and "Homocort." U 04/03/2001 UNK OTH OTH Claritin, Singulair, Homocort UNK Vesicular rash HQ0323001MAY2001 1
0172755 07/02/2001 KS U 05/04/2001 Pt experienced crying immediately post vax described as "worse...compared to (other) vaccines." Manufacturer's comment: The reporter was unable to specify the number of patients involved. Addtl rpts will be generated when identifying info is provided. U UNK OTH OTH UNK UNK UNK HQ0386202MAY2001 1
0172756 07/02/2001 CA 1.5 1 .5 M 05/15/2001 One day post vax, pt developed a "welt-like rash all over body and was itchy." He was treated with Benadryl. The pt recovered by 2/20/01. A copy of this report has been forwarded to Aventis Pasteur, manufacturer of the concomitantly administered vaccines. Y 02/16/2001 02/17/2001 1 UNK PVT PVT hydrocortisone UNK Allergic dermatitis HQ0443703MAY2001 1
0172757 07/02/2001 IA 0.2 0 .2 F 06/29/2001 Otitis Media - A medical assistant reported that a 2 mo rec'd Prevnar, Tripedia (Aventis Pasteur), Comvax (MSD) and IPOL (Aventis Pasteur SA) vaccines on 11/15/00. On 11/17/00, the infant developed crying and irritability. She was seen in an ER and diagnosed with otitis media. A copy of this report has been forwarded to Merck Sharp Dome and Aventis Pasteur., manufacturers of the concomitantly administered vaccine. Follow-up info received on 06/12/2001 indicated that the infant recovered. Y Y 11/15/2000 11/17/2000 2 UNK PVT PVT UNK UNK Crying, irritability and screaming following vaccine~Pneumo (Prevnar)~2~0.00~In Patient HQ0468903MAY2001 1
0172758 07/02/2001 NH 53.0 53 M 06/01/2001 Injection site reaction. A nsg reported that a pt rec'd his 1st Prevnar in 4/01 and immediately developed an injection site reaction characterized by erythema, tenderness and itchiness. Erythema and tenderness resolved within 4-5 days. and itchiness resolved within 10-14 days. The pt rec'd Prevnar because he is immunodeficient and is not to 21 valent pneumococcal vaccine (manufacturer unknown). Additional info rec'd on 5/23/01 indicated that the pt is IgG deficient and had a decreased antibody response following receipt of Prevnar. Y 04/01/2001 04/01/2001 0 antibody NOS abn -decreased antibody response OTH OTH Cardura, Claritin NONE Concurrent condition: blood immunoglobulin G decreased did not make an immune response~Pneumo (no brand name)~~0.00~In Patient HQ0004423APR2001 1
0172759 07/02/2001 IL 1.16 1 .2 F 06/28/2001 A physician reported (by a sales representative) that a 9 month old child received the 2nd dose of Prevnar and subsequently, developed invasive pneumococcal bacteremia. As of 5/2/01, no further information was available. Septicemia streptococcal is considered "Medically Important". Follow-up info received on 06/25/2001 indicated that a 9 month old female received her second dose of Prevnar on 03/13/2001. On 04/27/2001 at 10 months of age, she presented to the physician with irritability and fever. Her physical examination was normal; complete blood cell count, urine and blood cultures were obtained. White blood cell count was 25,100 with segmented neutrophils at 25, bands at 16 and lymphocytes at 23. Her hemoglobin was 12.0 with a hematocrit of 35.3. Urine culture was negative; her blood culture was positive for stretococcus pneumoniae. A diagnosis of pneumococcal bacteremia was made. The pt was treated with ceftriaxone socium and subsequenty with amoxicillin; she recovered. From follow up: Cancelled- This case has been found to be a duplicate of HQ0472203May2001 which will remain the case of record. Y 03/13/2001 04/27/2001 45 White blood cell count-25,100; neutrophil count-52; lymphocyte count-23; haemoglobin-12.0; haematocrit-35.3; culture urine-negative; blood culture-positive for streptcoccus pneumoniae PVT OTH NONE NONE UNK HQ0475103MAY2001 1
0172761 07/02/2001 CA U 03/12/2001 CONVULSIONS. A sales representative reported that a physician informed her that a child who received Prevnar. Infanrix (SKB) and IPV (Aventis Pasteur SA) subsequently, experienced a seizure. As of 07 Mar 2001. no further information was available. Copies of this report have been forwarded to SKB and Aventis Pasteur, Manufacturers of the concomitantly administered vaccines. This event is considered medically important. U OTH OTH UNK UNK UNK HQ8216509MAR2001 1
0172707 07/03/2001 NJ 1.5 1 .5 F 05/03/2001 Screaming. a mother reported her child received injection of Prevnar on 3/9/01. That evening the child was screaming, crying and unable to sleep through the night. She also developed a little knot at the injection site. The mother reported that the child had received a dose of Prevnar on 2/20/01. U 03/09/2001 03/09/2001 0 UNKNOWN PVT OTH Multivitamins, plain NONE UNKNOWN HQ8402514MAR2001 1
0172708 07/03/2001 WI 0.2 0 .2 M 05/30/2001 Blood in stool. A mother reported that her child received his 1st injection of Prevnar on 2/16/01. On 3/5/2001 he developed blood and mucus in his stools. The mother also reported that she stopped breast feeding and started giving him formula around the same time as his symptoms began. On 3/9/01, her son was seen by his pediatrician who suggested that she switch brands of formula. She complied but the bloody stools with mucus have continued. Additional information received from the infant's pediatrician on 5/29/01 indicated that the infant had slight amounts of hematochezia and his work up was perfectly normal. A pediatric gastroenterologist felt that the infant may have some mild low grade protein intolerance causing the hematochezia, The pediatrician stated that there is no evidence on my part nor on the gastroenterologist's part that Pneumococcal conjugate vaccine caused any particular side effects nor is responsible for the blood in the stools. Y U 02/16/2001 03/05/2001 17 UNKNOWN PVT PVT UNKNOWN NONE UNKNOWN HQ8456215MAR2001 1
0172763 07/03/2001 AR 0.5 0 .5 M 06/15/2001 Call from the child's grandmother states the child was taking a nap, and the child woke up crying. The aunt (taking care of child) gave the child a pacifier. She checked on the baby after 20 minutes and he wasn't breathing. Grandmother denies any problems at the time of vax. Death certificate states cause of death to be SIDS. Y 06/12/2001 N 06/08/2001 06/12/2001 4 PUB PUB NONE AR0128 1
0172764 07/03/2001 AK 39.0 39 M 03/05/2001 Per telephone conversation with pt on 3/5/01: Pt stated he works for fire dept. As a work requirement, he received Hep-A and Hep-B vaccinations on 1/25/01 in the AM at hospital. He stated that he received the IM injections in the deltoid muscles, 1 in left arm and the other in the right arm. He is uncertain which arm received which vaccine. Pt states that both arms were sore within 4 hours, post vax, but his right arm was especially painful to touch and movement. The pain in arms subsided after a few days. On 1/31/01, pt stated he experienced chest pain with "squeezing sensation" at 22:00. His left arm became numb after chest pain subsided and remained numb the next AM. Pt reported to work but at 09:00 went to the ER. He had a cardiac work-up but nothing was found. He was released from the hospital on 2/2/01. Pt was advised to quit smoking and was discharged with Zyban, Lipitor and clozapine. On 2/21/01, pt stated he was symptom free and that he had quit smoking on 2/14/01. In the AM, he used a solvent to remove adhesive. He broke out in hives all over his body. The hives became worse and at 22:00, he was seen at the hospital. He states he was given Benadryl. He was still covered in hives the next morning. On 2/23/01, woke up at 02:00 with a fever, aches and sore throat. On 2/24/01, pt stated he had pain under the right rib on palpation. Pt stated he continued to have hives on his face and upper arm. He had testicular pain. Pt stated that he had no appetite, difficulty sleeping, right knee pain during the next few days. Pt is being seen by surgeon for heartburn and bleeding in the esophagus. Pt states that it was suggested that he has a bacterial infection and that the Hep-A and Hep-B vaccination preceded the chest pain by 1 week, about time for an incubation period. Pt wonders why when he has been healthy all his life he should suddenly have all these problems and suggests that the vaccinations may have been causative. Y U 01/25/2001 01/25/2001 0 PUB UNK NONE AK200127 1
0172765 07/03/2001 MO 0.2 0 .2 F 06/18/2001 On 6/13/01, DTAP, IPV, Prevnar and Comvax was given and within 48 hours, post vax, child had 2 seizures. Temperature maximum of 100F. Admitted to hospital with EEG and full septic work-up which were negative. Placed on phenobarbital. Plan to wean off in 3 months. Y Y 2 Y 06/13/2001 06/15/2001 2 EEG/Full septic work-up-all neg OTH PUB NONE NONE MO2001035 1
0172766 07/03/2001 MS 1.0 1 .0 F 06/25/2001 1 year old white female had shots on 6/18/01. On 6/21/01, mom says she broke out all over, especially on face, by 6/19/01. On 6/23/01, she was asleep, became clammy, face and eyes swelled, had shallow breathing, had large welts on face and was unresponsive. Was taken by EMS from home to hospital and still in hospital on 6/25/01. Released from hospital on 6/25/01 and is improving. Y Y Y 3 Y 06/18/2001 06/23/2001 5 Blood work done. PUB PUB MS01030 1
0172768 07/03/2001 TX 4.0 4 F 03/30/2001 Pt developed a 5" oval area of erythema, heat and slight sensitivity to touch at injection site. 2-3 cm of the inside oval has a slight induration. Y 03/28/2001 NONE PUB UNK NONE NONE NONE TX01046 1
0172769 07/03/2001 TX 0.4 0 .4 F 04/27/2001 One day post vaccine pt developed a fine rash over trunk only. Y Y 04/26/2001 04/27/2001 1 NONE PVT PUB NONE NONE NONE TX01050 1
0172770 07/03/2001 TX 0.3 0 .4 M 04/18/2001 One hour after immunizations pt developed increased temp and fussiness. Pt also developed redness, swelling and rash to left half of head. Mother advised to take pt directly to ER. All attempts to follow up with parent failed. U 04/11/2001 04/11/2001 0 PUB UNK TX01053 1
0172771 07/03/2001 TX 57.0 57 M 05/01/2001 None Y 04/30/2001 Normal PVT OTH B12, American Regent, #0120, LA, 4/30/01 NONE TX01055 1
0172772 07/03/2001 TX 71.0 71 F 05/01/2001 None Y 04/26/2001 PVT OTH NONE TX01056 1
0172773 07/03/2001 TX 1.7 1 .7 M 05/08/2001 Two days after receiving vaccines pt developed a rash on left leg. U 04/18/2001 04/20/2001 2 PUB PUB NONE NONE NONE TX01058 1
0172774 07/03/2001 TX 1.3 1 .4 F 03/30/2001 Three hours post vaccine pt's right leg became swollen, red and warm to the touch. Mother was advised to apply warm compresses to site and monitor temperature. Y 03/28/2001 03/28/2001 0 PUB PUB 03/28/2001 HIB, Connaught, UA545AA, RL, 3 NONE TX01060 1
0172775 07/03/2001 TX 4.0 4 M 05/15/2001 Pt developed swelling in his left arm that happened overnight. His arm was red, very warm to touch and firm feeling. The area of induration went from shoulder to mid-arm. Tylenol and warm packs were suggested as treatment. Y 05/14/2001 05/15/2001 1 NONE PUB PUB NONE NONE NONE TX01076 1
0172776 07/03/2001 TX 4.0 4 M 06/08/2001 Pt experienced a local reaction on left deltoid (2x4 cm). Pt came into clinic with a temperature of 101.5. Y Y 06/05/2001 06/06/2001 1 PVT PUB UNK NONE TX01081 1
0172777 07/03/2001 TX 2.0 2 .0 M 06/07/2001 Pt's eyes became red and swollen 48 hours after vaccination. Mother advised to seek medical advice. Pt was seen by MD and is all right now. Y Y 05/31/2001 06/02/2001 2 NONE PUB PUB NONE NONE TX01083 1
0172778 07/03/2001 TX 0.2 0 .2 F 04/10/2001 Pt developed extreme crying for 48 hrs. She had 3 minutes of tonic clonic seizures 26 hrs after shots. She had decreased activity and eating for 4 days. Y Y 02/26/2001 02/26/2001 0 PVT PVT NONE NONE NONE 1
0172779 07/03/2001 TX 1.4 1 .4 M 05/24/2001 Pt developed a 4" by 6" erythematous area at injection site that was warm and nontender on left thigh. Y Y 05/22/2001 05/23/2001 1 PVT PVT NONE NONE NONE 1
0172780 07/03/2001 MO 0.4 0 .4 M 02/14/2001 Pt developed an area approximately 1" in diameter of tissue wasting in right thigh slightly above midline. Y U 11/29/2000 PUB PUB NONE NONE MO2001009 1
0172781 07/03/2001 AK 0.3 0 .3 M 04/06/2001 Pt cried from 3 PM on 4/5/01 until 3:05 AM on 4/6/01. Pt developed a fever of 101.4. Tylenol was given. The fever went down to 99.7. Y 04/05/2001 04/05/2001 0 PVT PUB NONE NONE NONE AK200124 1
0172782 07/03/2001 AK 0.7 0 .7 F 04/30/2001 Pt developed vomiting and diarrhea the day after receiving vaccines. She felt warm and had decreased activity. GI symptoms stopped. She broke out in a macular rash on trunk and head. Eyes looked red and puffy. Suboccipital nodes were swollen. 04/26/2001 04/27/2001 1 PUB PUB NONE NONE AK200133 1
0172783 07/03/2001 AK 0.5 0 .5 F 05/07/2001 Pt developed a red, raised area the size of a quarter on right upper anterior thigh. It reduced in size to 1/2 a dime within 24 hours. Pt ran a temperature of 100-101 from 5/3/01 to 5/7/01. On 5/7/01 the area had a bruised look. Tylenol was used to bring temperature down. Pt also had a cough, fussiness, poor appetite and change in sleep schedule. Y 05/03/2001 05/04/2001 1 NONE OTH PUB NONE NONE NONE AK200137 1
0172784 07/03/2001 MS 1.25 1 .3 M 06/25/2001 Pt developed large swollen area on lateral aspect of left thigh on 6/20/01. The swelling was soft peripherally but firm centrally. On 6/22/01 pt had cellulitis of left thigh. Y 06/19/2001 06/20/2001 1 PUB PUB Albuterol syrup NONE Being evaluated for Hyper IgE Syndrome MS01029 1
0172785 07/03/2001 MS 1.8 1 .8 F 06/25/2001 Pt noted to have a fever up to 102 on 6/10/01. Pt was given oral antipyretic and while on mother's lap went limp and unresponsive for less than 5 minutes. Pt transported to local ER for evaluation and was noted to be fit for discharge. Y Y 06/07/2001 06/10/2001 3 EEG-wnl; blood cx-neg PUB PUB NONE NONE NONE MS01028 1
0172786 07/03/2001 WI 0.4 0 .4 F 06/29/2001 Pt developed a fever on 4/17/01. Health Dept contacted 4/18/01 re: pt with fever of 103. Fever did come down with Tylenol. The fever continued all week and went up as far as 105.9. Pt's father contacted hospital ER and was instructed to keep giving Tylenol. Pt did have inconsolable crying during week. Y 04/16/2001 04/17/2001 1 PUB PUB NONE NONE 1
0172787 07/03/2001 TX 2.0 2 .3 F 03/30/2001 Pt developed an oval, erythemic area of 4.5" on left lateral leg at injection site that was slightly sensitive to touch. 2-3 cm of the inside of the oval had a section of induration. Y 03/28/2001 03/29/2001 1 NONE PUB UNK TX01043 1
0172788 07/03/2001 TX 4.0 4 F 04/06/2001 Pt developed a hard, erythemic induration incorporating entire left thigh from groin to above knee. Pt also developed a pustule at injection site. Pt had no evidence of abscess. Y Y 04/02/2001 04/03/2001 1 Xray-wnl; lab-wnl PVT PUB PPD placed 4/2/01, results 4/4/01 neg NONE NONE TX01042 1
0172789 07/03/2001 TN 0.2 0 .2 F 06/26/2001 Pt became fussy with crying and a decreased appetite for a short time. Y 06/14/2001 06/14/2001 0 PVT PVT Nystatin Thrush 1
0172790 07/03/2001 TN 0.2 0 .2 F 06/26/2001 Shortly after DTaP injection, pt became quiet and pale for a short time. She responded well to stimulation and resumed normal appearance and activity immediately after stimulation. Y 06/14/2001 06/14/2001 0 PVT PVT Nystatin Thrush 1
0172791 07/03/2001 IL 0.75 0 .8 F 06/25/2001 Sixteen hours after receiving immunizations, pt developed a fever of 103.9. She had no other symptoms. She was treated with Tylenol and fever resolved. Y 06/21/2001 06/22/2001 1 PVT PVT NONE NONE NONE 1
0172793 07/03/2001 IL 1.0 1 .0 M 06/26/2001 From 6/20/01 to 6/23/01 pt had a low grade fever. On 6/23/01 he had redness and a knot on right medial thigh area. On 6/25/01 he began to have a rash to face, trunk, arms and legs,and mother took pt to MD. On 6/26/01 mother called health dept to report that the knot looked better but that the pt continued to have rash to entire body. Y U 06/15/2001 06/20/2001 5 NONE PUB PUB Tylenol, Orajel NONE NONE IL01024 1
0172794 07/03/2001 WA 0.2 0 .2 M 06/26/2001 Pt developed axillary temp of 107 degrees 30 hours after receiving vaccines. Pt felt hot and was very fussy and crying. 1 hour after Tylenol the pt's temp was 98.8. Y 06/14/2001 06/15/2001 1 NONE PVT PUB NONE NONE NONE 1
0172795 07/03/2001 TX 1.0 1 .0 M 06/26/2001 Pt developed a large knot where Prevnar was administered. When examined the knot was approximately 1" in diameter with discoloration. Pt also had vomiting. Pt was diagnosed with adverse reaction/hematoma. Y 06/21/2001 06/22/2001 1 NONE PVT PUB NONE AGE, vomiting NONE 1
0172796 07/03/2001 WA 1.25 1 .3 M Pt developed maculopapular, erythematous rash approximately 48 hours after immunizations. Pt also had some crankiness/irritability. Y U 05/08/2001 05/10/2001 2 PVT PUB NONE Fever 100.9 NONE 1
0172797 07/03/2001 NV 1.25 1 .2 F 06/25/2001 Pt developed a significant maculopapular rash all over body. There was a similar rash in twin and another patient from same lot of MMR and Varivax. U 06/14/2001 06/23/2001 9 PVT PUB ~Measles + Mumps + Rubella (MMR II)~1~1.25~In Sibling 1
0172798 07/03/2001 NV 1.25 1 .2 F 06/25/2001 Pt developed a maculopapular rash. A similar rash developed in twin and another pt that had vaccines from the same lot of MMR and Varivax. U 06/14/2001 06/24/2001 10 PVT PUB ~Measles + Mumps + Rubella (MMR II)~1~1.25~In Sibling 1
0172799 07/03/2001 PA 2.0 2 .0 M 06/08/2001 Pt complained of pain at injection site the evening after appointment. Redness developed at site on right thigh with warmth developing through the night. Mother noticed a white center at injection site. Y 06/06/2001 06/07/2001 1 NONE PUB PVT NONE mild cold symptoms NONE PA0149 1
0172800 07/03/2001 MT 2.0 2 .2 F 06/22/2001 Pt developed hives on 6/19/01 on left leg. By the next morning, the rash was over entire body from bottom of feet to head. Pt treated with Benadryl and calamine lotion. Y 06/19/2001 06/19/2001 0 NONE PUB PUB NONE NONE NONE 1
0172801 07/03/2001 MI 0.73 0 .7 F 05/21/2001 5/14/01 Prevnar given 11am, by 6pm mother reports slight fever (no temp taken tylenol given. 5/15 - ok today still slight fever & cranky. 5/16/01 woke with red, non raised diffused rash on chest, abd & back and fever continues. 5/17/01 rash spread to legs front & back - to Dr who examined throat & ears and told Mom was from shot 5/14/01. Given Rx benadryl. No rash by morning of 5/18/01. Y 05/14/2001 05/16/2001 2 PUB PVT NONE NONE NONE 1
0172802 07/03/2001 OH 0.33 0 .3 F 06/14/2001 Pt developed hives on legs within 5-10 minutes after receiving IZ. One hive appeared on R front lower leg, 15 hives appeared on L leg. Redness size of quarter appeared around site of IPV injection. Sent to ER. Take benadryl. Sent home. Reported to Dr. Y Y 06/14/2001 06/14/2001 0 PUB PUB OH0039 1
0172803 07/03/2001 NY 2.0 2 .2 F 06/28/2001 L leg local reaction possible early cellulitis. 06/26/2001 06/28/2001 2 PVT OTH PPD L forearm NO NO 1
0172804 07/03/2001 TX 1.3 1 .4 M 03/21/2001 Noticed this AM, whelps on R leg diameter 130mm L leg @ site of Hep B & Prevnar. R leg local irritation 42mm. Child is walking w/o problems. Afebrile. Noted some hardness @ injection sites. Band Aids were left on > 24hrs. Advised warm moist compresses. Tylenol/motrin. Call in 2 days if whelps still present. Y 03/19/2001 03/20/2001 1 PUB UNK NO NON SPECIFIED TX01044 1
0172805 07/03/2001 TX 3.0 3 F 05/18/2001 Cellulitis to L thigh - lateral (posterior) VS allergic reaction to vaccine R thigh lateral (posterior). (both legs) U 05/16/2001 05/18/2001 2 NONE PUB PVT NONE Stye to R eye NONE TX01063 1
0172806 07/03/2001 TX 3.0 3 M 05/18/2001 Cellulitis to back of L thigh - lateral VS a septic abscess U 05/16/2001 05/18/2001 2 PUB PUB NONE NONE TX01064 1
0172807 07/03/2001 TX 1.0 1 .0 F 05/16/2001 R thigh cellulitis VS allergic reaction VS septic abscess. 05/14/2001 05/16/2001 2 NONE UNK PUB NONE NONE NONE TX01065 1
0172808 07/03/2001 TX 1.0 1 .0 M 04/26/2001 After the injections were given, later in the day there was a lot of edema, redness and firmness noted around the injection site. This lasted up to this AM. The family applied cold and warm packs and tylenol was given. Today the site is slightly red-small amounts of edema and it is sore to touch. 04/25/2001 04/25/2001 0 NONE PUB PUB NONE NONE NONE TX01073 1
0172809 07/03/2001 TX 0 .4 F 06/18/2001 L thigh had inflamed area, whelped with red bumps >silver dollar in size per report of mother and grandmother. Onset PM after infection lasting several days. Y 03/09/2001 03/09/2001 0 PUB PUB TX01084 1
0172810 07/03/2001 TX 0.5 0 .5 F 05/18/2001 Urticaria day after vaccines, seizures, arching of back with jerking of head and eyes to left. Y Y 05/16/2001 05/17/2001 1 EEG ordered PVT PVT NONE NONE NONE 1
0172811 07/03/2001 TX 2.0 2 .0 M 05/24/2001 Erythematous and was warm and non tender 4" x6" at L thigh injection site. Y Y 05/21/2001 05/23/2001 2 PVT PVT NO NO 1
0172812 07/03/2001 TX 1.4 1 .4 M 05/24/2001 L thigh 11x8cm redness swelling, warmth 48 hrs after vaccines administered. Seen in ER 10/8/00. Rx Rocephin & PO ? and benadryl. Y Y 10/06/2000 10/10/2000 4 PVT PVT Zithromax Otitis media 1
0172813 07/03/2001 AK 2.0 2 .7 F 03/07/2001 Immediately after giving the immunization, Prevnar, the area surrounding the injection was red. The area of redness was still present 10-15 minutes post vaccine. No redness was noted in her right deltoid where the Hepatitis A was given. Mom contacted PHN on 3/6/01. She reported her left deltoid area was red and puffy over the weekend. She reports the redness to be approximately 2" in diameter & a bubble at the injection site. Mom denied her having a fever, body aches. Mom reports the swelling and redness to be going away. Y 03/02/2001 03/02/2001 0 PUB PVT NONE Allergic to dairy AK200120 1
0172814 07/03/2001 NC 1.08 0 .9 M 06/25/2001 10 days after vaccine - developed erythematous papules all over trunk, face, fever. Y U 06/14/2001 06/24/2001 10 PVT PUB NONE NONE NC01056 1
0172815 07/03/2001 NJ 67.0 67 F 06/28/2001 Patient was given Lymerix vaccine (her 3rd shot) at 4:20pm on 6/13/01, she developed chills, shaking all over, heart pounding at 5:50pm. The reaction stopped 1 1/2 hrs later. Y 06/13/2001 06/13/2001 0 PVT PVT unknown~Lyme (LYMErix)~2~66.00~In Patient 1
0172816 07/03/2001 TX 40.0 40 M 04/26/2001 IZ received @ 3:30pm 4/25/01. C/O fever 99.9F @ 6pm 4/25/01, took regular strength tylenol 2 tabs po x 1 dose. Fever gone at 2pm 4/26/01. When pt woke up at 5am 4/26/01 he c/o dizziness and wheezing. Took 1 dose benadryl (otc) at 5:30am and slept. Denied problems @ present 1:30pm 4/26/01. Y 04/25/2001 04/26/2001 1 NONE PUB PVT PPD/connaught/c0153AB/4/9/01 & 4/23/01. Zoloft, propoxyphene cold/sinus symptoms NKA, no birth defects TX01049 1
0172817 07/03/2001 TX 14.0 14 F 04/24/2001 12/5 rec'd chickenpox vaccine, 12:30 swelling in eyes noted, wheezing noted. BP 118/88, P 96. 05cc epinephrine given sq Lt deltoid, 50mg benadryl IM/LD, 12:35 paramedics here,12:45 left via stretcher to Henderick Hlth System, follow up from mother 4/24/01 - in ER x 3hrs, observed no other problems. Y Y 04/21/2001 04/21/2001 0 NONE PUB PUB NONE NONE NONE TX01048 1
0172818 07/03/2001 TX 34.0 34 F 04/02/2001 Received Td vaccine at 3:53pm on 4/2/01, client developed dizziness @ 3:58pm, itching, tingling around her mouth @ 4:05pm also c/o nausea. Epinephrine 0.3ml sq administered @ 4:09pm. Denied any SOB respiration even and unlabored. To Baylor hospital @ 4:24pm by paramedics. Y Y 04/02/2001 04/02/2001 0 don't know what test performed OTH PUB medicine for back pain, anxiety TX01047 1
0172819 07/03/2001 TX 4.5 4 F 05/01/2001 Child broke out in hives all over body afternoon of day vaccine was given. Taken to ER by parents, oral benadryl prescribed. Child completely recovered by next day. No other symptoms. Y Y 04/21/2001 04/21/2001 0 OTH OTH NONE NONE NONE TX01052 1
0172820 07/03/2001 TX 1.32 1 .3 F 05/02/2001 Patient returned 05/02/01 child's leg at site of injection red swollen and warm to touch. (allergic reaction to injection site per PA.) zero complaint of fever (10 cm erythematous induration per PA.) child prescribed PED/APRED 5mg/5ml and ATARAX 10mg/5ml. Ice pack to site. Instructed to return tomorrow. Y 04/30/2001 05/02/2001 2 UNK UNK TX01051 1
0172821 07/03/2001 TX 1.1 1 .1 M 05/03/2001 Patient seen by Dr. 04/14/01. Patient diagnosed with varicella zoster per Dr. Mother c/o fever on Sunday 04/15/01. Woke up with rash 04/16/01 zero itching. Y Y 04/06/2001 04/16/2001 10 UNK UNK TX01054 1
0172822 07/03/2001 TX 12.0 12 M 05/04/2001 Low grade temp 99, 2 and red, pin-point, unraised rash abdomen. Y 05/01/2001 05/02/2001 1 PVT PVT Celexa / Trazodone Denies Depression rash~Hep B (Recombivax HB)~1~12.00~In Patient TX01057 1
0172823 07/03/2001 TX 12.0 12 F 05/03/2001 Patient was given .5 of TD right deltoid localized reaction about 30 X 30 mm warm to the touch. Imm. given at local TDHP Y 04/30/2001 04/30/2001 0 PVT UNK UNK TX01059 1
0172824 07/03/2001 TX 1.7 1 .7 M 04/26/2001 04/24/01: Vaccines given in morning (before 11:00 ) Received DTAP #4 and Hib #4 in left lateral thigh. Approximately 4 hours after receiving vaccine child developed large red area (also warm and hard) in area of shots. Child had temperature of 100.5 that night 11:00 pm and was given tylenol. Child active walking and playful hot affected area is uncomfortable when touched. Y Y 04/24/2001 04/24/2001 0 PVT UNK NONE NONE TX01068 1
0172825 07/03/2001 TX 37.0 36 F 04/20/2001 Right deltoid area warm to touch, some redness some swelling and patient states very itchy and can't move arm up and down with bad pain. Y N 04/18/2001 04/19/2001 1 NONE PVT PVT NONE NONE NONE TX01067 1
0172826 07/03/2001 TX 11.0 11 F 05/15/2001 Mother reports illness lasted approx. (3) days. PMD seen on 05/14/01. Soreness to arms -- no discoloration, swelling, warmth Severe headache, dizziness, loss of appetite, nauses. Temp on day #2 of 103.2 orally. Motrin (OTC) admin by MO. PMD order: Do not complete hepatitis series. Y Y 05/11/2001 05/11/2001 0 No tests/ laboratory performed at this time. PVT PVT Amoxicillin taken 3 days prior - throat infection NONe None TX01062 1
0172827 07/03/2001 TX 21.0 21 F 04/25/2001 Pt c/o severe pain in right knee. She was unable to walk well. Pt noticed indurated area on right lateral knee, right shin and left lateral lower leg. She c/o right heel hurting. Pt denies increased temperature. Pt denies this same reaction with first set of vaccines. Pt denies headache, nausea & vomiting. Erythema dermatosis. Y Y 04/23/2001 04/23/2001 0 PUB PUB NONE NONE TX01061 1
0172828 07/03/2001 TX 1.6 1 .6 M 11/21/2000 Pt developed generalized body rash. As of report date, pt still had some rash on torso and legs but it looked old in nature. Y 10/24/2000 10/26/2000 2 PUB UNK NONE TX01075 1
0172829 07/03/2001 TX 48.0 47 F 05/02/2001 Pt developed feelings of numbness in legs, backache and neck pain 3-4 wks post vax. It was explained to her that these symptoms were not side effects of this TD booster, and if there was a reaction, it would have occurred within 24 to 48 hours. 02/24/2001 MRI PUB PUB NONE UNK TX01074 1
0172830 07/03/2001 TX 9.0 9 F 03/30/2001 Pt developed redness at injection site of hepatitis B. Pt c/o soreness radiating up to neck within 30 min of receiving vax. Mother states vax given with wrong needle. Nurse reports she gave injection with 25 gauge 5/8" needle. As of 3/30/01, there was no redness and no soreness. Y 03/29/2001 03/29/2001 0 PUB PUB TX01072 1
0172831 07/03/2001 TX 11.0 11 F 03/30/2001 Pt c/o of redness and soreness at injection site of Hepatitis B within 30 minutes of receiving vax. Mother states vax given with wrong needle. Nurse states given with 25 gauge 5/8". Y 03/29/2001 03/29/2001 0 PUB PUB TX01071 1
0172832 07/03/2001 TX 11.0 11 M 05/18/2001 Pt developed edema to right eyelid and small patches of rash on face. Y 05/15/2001 05/15/2001 0 NONE PUB PUB NONE NONE NONE TX01080 1
0172833 07/03/2001 TX 11.0 11 F 05/16/2001 Pt was seen with a positive red wheal local reaction on right arm to tetanus shot. Y 05/12/2001 05/16/2001 4 PVT PUB PPD, Connaught, C0153AA, LA, Tylenol, Cefzil bilateral otitis media, cough TX01079 1
0172834 07/03/2001 TX 40.0 40 F 05/14/2001 Pt c/o redness, tenderness, hardness and blisters at injection site since 05/11/01. This occurred 24 hours post vax. Pt also c/o arm weakness. Instructed pt to apply warm compresses 1 hr 3x/day. Instructed pt to rest arm as necessary and if not resolved to see MD by 5/18/01. Pt agreed to plan of action. 05/10/2001 05/11/2001 1 OTH OTH TX01078 1
0172835 07/03/2001 TX 13.0 13 M 05/30/2001 About 1.5 hrs post vax, pt became shaky with trembling hands and complained of headache and nausea. Temp was 103.5. Pt remained febrile until 1 AM after being medicated with Tylenol. As of 5/30/01, pt had no problems. Y 05/29/2001 05/29/2001 0 NONE PUB PUB NONE NONE Treated 5/18/01 for strep throat w/ penicillin TX01077 1
0172836 07/03/2001 TX 1.08 1 .1 M Pt developed temp of 105 on 6/11/01. Pt was given Motrin for fever. Temp controlled with medication. Pt also developed small swollen area and rash at site of vax. Y 06/11/2001 06/11/2001 0 NONE PVT PUB NONE NONE TX01082 1
0172837 07/03/2001 TX 3.0 3 F 06/14/2001 Pt developed an erythematous plaque at injection site of DTAP and IPV. Pt treated with prednisone x 5 days and prophylactic Keflex. Follow-up 24 hrs later indicated a 50% reduction in size of lesion. MD believes it was a panniculitis due to ice cube applied by aunt after administration of DTAP. Y 06/12/2001 06/14/2001 2 NONE PUB PUB NONE NONE NONE TX01085 1
0172838 07/03/2001 TX 1.4 1 .4 F 05/29/2001 Pt developed fever of 105 axillary on 5/24 at 17:45. Pt had 2 convulsions approximately 5 min apart. Mom gave Advil and tepid bath and then pt slept. MD saw pt next day and she still had fever. Treated with Tylenol and Advil. Pt had fever 5/25, none on 5/26, up to 101 on 5/27. Pt had no fever since 5/27. Y Y 05/24/2001 05/24/2001 0 NONE PVT PVT TB skin test, Pasteur, C0256AA, RA; Ceftin ear infection 5/15/01 recurrent otitis media 1
0172839 07/03/2001 MD 4.0 4 M 04/23/2001 Pt developed a 7" erythematous area from shoulder to elbow involving entire upper arm. Y Y 03/30/2001 04/01/2001 2 NONE PVT UNK NONE 1
0172840 07/03/2001 AK 11.0 11 M 04/10/2001 Approximately 5 min post vax, pt was in his chair in the classroom and slid out of chair from fainting. Teacher and school nurse took care of the incident. Mother took pt to MD the next day. Y Y 03/27/2001 03/27/2001 0 OTH PUB NONE AK200123 1
0172842 07/03/2001 AK 9.0 9 M 03/29/2001 Five minutes post vax, pt became pale and complained of stomach ache. Pulse remained steady. Pt somewhat tired and "out of it" afterwards but never lost consciousness. Pt complained of feeling faint and hot. Vasovagal reaction to immunizations. In Feb 2001 pt received Hep A, Hep B and varicella immunizations, first dose for each in series. Post vax he became pale and lost consciousness, questionable seizure. Y 03/21/2001 03/21/2001 0 NONE PUB UNK NONE NONE pale, lost consciousness, ? seizure~Hep B (no brand name)~1~9.00~In Patient AK200121 1
0172843 07/03/2001 AK 9.0 9 M 02/27/2001 Within 4 or 5 minutes of vaccinations child complained of tummy ache, become pale, and passed out. Heart rate increased 96/regular and strong. Child unresponsive for 30 seconds both eyes remained open/almost laughing//arms went into fence position. Remained pale, nauseated for 10 minutes after woke up. Y 02/20/2001 02/20/2001 0 NONE PUB OTH None NONE NONE AK200119 1
0172844 07/03/2001 AK 6.0 6 F 03/15/2001 Pt had sore arm for 2 days after shot. Headache began in 2 hrs and lasted 5 days. Stomach pain and nausea began after 2 days and lasted 1 day. Fever of 103 degrees 4-5 days later. Lethargic, hard to arouse, talking without making sense, blood shot and puffy eyes for 1 day when she had the fever. Recovered about day 6, still had loose stools. Y Y 02/15/2001 02/15/2001 0 had blood tests at doctor visit-Dr Fernau PUB PUB NONE Reacted to Tylenol with lethargy ~Hep A (no brand name)~~0.00~In Sibling AK200118 1
0172845 07/03/2001 AK 13.0 13 F 03/05/2001 Pt told father on 2/12 that he had hives which started on trunk, back, feet, legs, hand, neck, face and then explosively all over. Pt saw PA 2/20 and treated with antihistamines. Pt saw MD and treated with steroids. Had respiratory problems. Pt is tapering steroids. Pt missed 2 wks of school. Y N 01/29/2001 02/10/2001 12 PUB PUB NONE NONE NONE AK200117 1
0172846 07/03/2001 AK 15.0 15 F 03/28/2001 Three days post vax, pt's left upper arm became swollen, warm to touch and tender. Pt saw MD who gave her medications orally to reduce swelling. Repeat visit to MD next day showed swelling had gone down. Pt had no fever. Y Y 10/05/2000 10/08/2000 3 NONE PUB UNK NONE NONE excessive swelling, redness~DTP (no brand name)~5~5.00~In Patient AK200114 1
0172847 07/03/2001 MO 15.0 15 M 06/21/2001 Pt broke out in hives (red, raised) approximately 1.75 hrs post vax. Hives spread to both legs and abdomen and later in the night spread to chest and neck. Mother denies increased temp. Mother phoned ER and was instructed to give Benadryl which she did. On 6/21, hives looked better. Mother took pt to Health Dept on 6/21/01 and was referred to MD's office. Y 06/20/2001 06/20/2001 0 NONE PUB PUB NONE NONE Allergic to penicillin, sulfa, Zithromax rash~Measles + Mumps + Rubella (MMR II)~~0.00~In Patient|~DTP (no brand name)~~0.00~In Sibling MO2001036 1
0172848 07/03/2001 MO 0.5 0 .4 F 06/18/2001 On the evening of 6/14/01, pt had fever. She had no other signs/symptoms. This resolved. On 6/17/01, she became fussy and on 6/18/01, she had rash on back and face. This lasted 24 hours. Symptoms all resolved. Y 06/14/2001 06/17/2001 3 NONE PUB PUB NONE NONE NONE 1
0172849 07/03/2001 AK 10.0 10 F 05/07/2001 At 10 PM on 4/24/01, pt had nausea, vomiting, diarrhea and fever of 100-101. She was improved by 1 PM on 4/25/01. Y 04/24/2001 04/24/2001 0 NONE PUB UNK NONE NONE AK200132 1
0172850 07/03/2001 AK 1.08 1 .2 F 04/30/2001 Pt developed immediate skin redness, warmth and scattered red welts that erupted after IPV given. Pt became irritable. There was no respiratory distress noted. Vital signs remained stable. Pt referred to MD for evaluation. Y Y 04/20/2001 04/20/2001 0 PUB PUB NONE NONE NONE AK200131 1
0172851 07/03/2001 AK 10.0 10 F 03/06/2001 Pt fainted after Hep B vax. Ammonia was used to revive her, and she had a seizure. Pt was lowered to the floor and had a second seizure. Her pulse was 40, and her skin was pale. Pt revived after her feet were elevated. She recovered well after about 60 seconds. Y 03/06/2001 03/06/2001 0 Pulse 40 PUB PUB NONE NONE fibrous dysplasia of jaw (Cherubism) AK200130 1
0172852 07/03/2001 AK 1.9 1 .7 F 06/14/2001 Broke out with 15 pox unilateral face and arm. Developed 1-2 more pox each day for next two days. Total 18 pox per mom. No fever no coryza- (+) cranky/grumpy. Resolved without incident-some scars per mom. Fine now. (Pox developed bilateralley after first day). Y 02/14/2001 05/25/2001 100 Not Brought in PVT PUB NONE Large VSD With repair 12/3/99 with CHF post repair 12/15/99 resolved X 1 yr AK200129 1
0172853 07/03/2001 AK 35.0 35 F 05/21/2001 Patient was administered an immunization for Rubella, and a TB skin test at the same time. Approximately 40 hours later she reported swellling of her bottom lip and diarrhea. (She had noticed the swelling to her lip on the previous day. ) Patient has a history of childhood allergies up until about ten years ago, and whenever she had a reaction it would elicit this type of response. She was seen in the hospital emergency room for an evaluation and treatment. The physician noted the swelling of her lower lip. There was no edema intraorally. Her lungs had a prolonged expiratory phase with mild expiratory wheezing. The diagnosis was an allergic reaction with reactive airway component. She was treated initially with hydroxyzine 50 mg, to be taken every 4-6 hours; and tagamet 400 mg up to t.i.d. She was also given a peak flow meter to monitor her respiratory status. She had no further problems and her reaction subsided after 24 hours. Y Y 01/29/2001 02/02/2001 4 PVT PVT PPD Aventis Pasteur C0578AA LA 01-29-01 Allergies as child, otherwise negative history AK200128 1
0172854 07/03/2001 AK 47.0 47 F 04/03/2001 Received TD booster 03/28/01. Within 10 hours developed fever to 101 and severe headache that lasted about 48 hours. Arm so sore had decreased range of motion for 4 days. At time of injection, felt nerve hit with pain down to middle finger (+) nausea. Y 03/28/2001 03/28/2001 0 NONe PUB PUB NONE NONE- felt perfectly well NONE AK200126 1
0172855 07/03/2001 AK 16.0 16 M 04/10/2001 Began vomiting sat. am. and has had intermittent stomach cramping, some loose stools. No fever noted. No appettite, no energy. Has kept down toast today, no vomiting since 7am 04/06/2001 04/07/2001 1 PUB UNK Possible allergy to penicillin. (runs in family) AK200125 1
0172856 07/03/2001 AK 1.08 1 .1 F 05/16/2001 MMR and varicella vaccine given 05/02/01 mom states patient developed spots head to toe apx 05/13/01 with fever. MOM did not take temperature, but patient felt warm, gave, tylenol x1, rash may more generalized with more distinct "dots", fussy, decrease appetite rash also to face and lips. no problems breathing. Is also cutting teeth. Advised her to have patient seen by health care provider, follow up on 05/17 - patient seen by physician mom states he felt maybe MMR, wrote medial exemption for patient Y 05/02/2001 05/13/2001 11 PUB PUB NONE NONE cantelope (rash) fussy~DP + IPV (no brand name)~1~2.00~In Patient AK200136 1
0172857 07/03/2001 AK 4.0 4 M 04/30/2001 Immediate skin flushing: red, blotchy areas on upper chest, cheeks, arms, buttocks, ears. Redness would come and go over 20 min. period. Vital signs WNL. No resp. dizzness. Referred to MD 20 min after vaccine given Y Y 04/27/2001 04/27/2001 0 PUB PUB tegretol NONE epilepsy AK200135 1
0172858 07/03/2001 AK 13.0 13 M 05/08/2001 Patient developed PET echial stain lesions and edema in feet and lower extremities. Diagnosed with HENOCH- SCHONLEIN Purpura. Symptoms began 2 days after receiving first doses of HEP A and Hep B vaccine Y N 04/26/2001 04/28/2001 2 cbc, pt, ptt drawn at M.D office PUB PUB NONE NONE NONE AK200134 1
0172859 07/03/2001 AL 1.0 1 .0 M 06/19/2001 24 hours after IMM's developed rash with fever, generalized erythema, 1 papula left neck no itch no pain no burning no hives. temp 100.5 Y 06/12/2001 06/13/2001 1 NONE PUB PUB Floride drops (used x 1 with symptom Debrox Otic (not used with onset of sx) NONE NONE (+) RSV 03/07/2001-resolved (5/25 sulface tamide opth sol. 5/15 sudafect / Guafetasa) AK200142 1
0172860 07/03/2001 AK 27.0 27 F 05/29/2001 One day post vax pt's arm ached, and she had difficulty dressing. She developed nausea and fever that night and stiffness and headache started the next day. Temp went up to 102. She had chills and sweating on Monday and Tuesday. Fever was gone but headache and stiffness continued. Pt has morning stiffness in neck and shoulders. Y Y 05/25/2001 05/26/2001 1 NONE PUB PUB Advil Coughing NONE AK200141 1
0172861 07/03/2001 AK 49 F 05/15/2001 TD given 05/11/2001 approx. 3p.m. adm. with biojector "Burned" as soon as administered and continued on. Bruised immediatly redness and aching Sunday. Fingers began going numb Sunday. Went to ER Monday am (Headache after injection intermittent now) Y N 05/11/2001 05/12/2001 1 PUB PUB Atenolol 12.5 od, Lisdnopril 10 mg od, Estrogen 1625 every day, maxhir inh. Prn advil prn. NONE Codiene, Asthma, Hayfever AK200140 1
0172862 07/03/2001 AK 52.0 52 F 06/11/2001 7 days after routine td boaster client experienced extreme soreness (awaken by soreness X 3 nights), itching, swollen and hot x 3-4 days, and pinpoint rash (start) to large redden blotch area x 4 inches below injection site (4 X 3 size area) X 3 weeks, relieved with ibprofen and ice packs X 4 days, per advice of private MD (telephone) Y 05/09/2001 05/16/2001 7 NONE OTH PUB NONE NONE NONE AK200139 1
0172863 07/03/2001 AK 1.2 1 .2 M 05/30/2001 Rash on trunk and face appeared 5/25/00 - presented to hospital out patient dept 5/26. No fever, coryza, cough or conjunctivitis. Pt seen by PHN 5/29/01 no rash apparent. Y 05/16/2001 05/25/2001 9 IgG/IgM serologic testing for measles drawn but held - vaccine -live MMR given 9 days prior. PUB PUB AK200138 1
0172864 07/03/2001 PA 33.0 33 F 06/08/2001 The pt experienced a high fever of 102, chills, muscle aches, joint pain, left arm pain, headache, watery eyes, nausea. The pt was referred to the ER. Y 06/14/2001 06/14/2001 0 NONE PUB PUB NONE NONE egg allergy PA0150 1
0172865 07/03/2001 MI 18.0 18 F 06/27/2001 The pt experienced arthralgia to the elbows, hands and knees occurring 4 days post vax. Pain and stiffness was worse when placing pressure on joints. Itching of hands and feet. No fever or other symptoms. Y Y 06/12/2001 06/16/2001 4 CBC, ESR, TSH and Liver panel PVT PVT Desogen NONE previous reaction to Dialudid and reaction to DTP as a child. 1
0172866 07/03/2001 OR 9.0 9 F 06/16/2001 The pt developed erythema multiforme rash on 5/18/01. The rash resolved over a 5 day period. Y 05/16/2001 05/18/2001 2 NONE PVT PVT NONE NONE 1
0172867 07/03/2001 MT 0.3 0 .3 F 06/28/2001 One day post vax the pt became irritable, crying, screaming for 7 hours with only brief periods when she could be consoled. Possibly low grade temp and had Tylenol. Y U 04/23/2001 04/24/2001 1 PUB PUB 1
0172868 07/03/2001 NY 77.0 77 F 06/28/2001 The pt experienced a 3cm red area around the area where she received her shot. Y 06/26/2001 06/27/2001 1 PVT PVT 1
0172869 07/03/2001 OH 1.25 1 .3 F 06/19/2001 Same day of vax, the pt became lethargic, fever, cold and clammy, starred into space. It was noted increased respirations and wheezing. Pulse was 168, respirations 58. Paramedic examined child and the child was acting normal. Lungs are cleared and the child was given Motrin. Child began acting fussy and decreased fever. Y 06/12/2001 06/12/2001 0 NONE PUB PUB NONE NONE NONE OH0037 1
0172870 07/03/2001 OH 0.3 0 .4 F 06/13/2001 The pt experienced decreased appetite and slept allot. Mother gave Tylenol. The pt experienced "funny" breathing, irregular respiration for about 1/2 hour. The pt then developed hives. Y 06/12/2001 06/13/2001 1 NONE PUB UNK NONE NONE OH0038 1
0172871 07/03/2001 OH 32.0 32 M 06/21/2001 One day post vax, the pt experienced a fever up to 104, redness to arm and tightness to the site with minimal swelling. Complained of dizziness, stiff neck, achiness, hallucinations, head "tight". The pt was advised to see physician. ER administered IV for dehydration and the pt was told is "allergic to vaccine". No further symptoms. Y Y 06/18/2001 06/19/2001 1 NONE PUB PUB work injury for finger requiring stitches. OH0040 1
0172872 07/03/2001 IN 4.0 4 F 06/25/2001 On 6/25/98 pt received Varivax, on 10/4/00 had chicken pox with approximately 100 lesions. Treated with Benadryl and Tylenol. Y Y 06/25/1998 10/04/2000 832 NONE PVT PVT NONE NONE NONE 1
0172873 07/03/2001 AL 1.6 1 .5 F 06/25/2001 The pt experienced red whelp like areas on legs, arms and trunk. No blisters. Whelps vary in size from 1-2 cm. The child is active and alert. U 05/31/2001 06/23/2001 23 PVT UNK NONE NONE NONE 1
0172874 07/03/2001 CT 4.0 4 M 06/25/2001 The pt experienced parotitis. U 06/11/2001 06/24/2001 13 NONE PVT PUB NONE NONE NONE 1
0172875 07/03/2001 CO 1.5 1 .5 M 06/27/2001 The pt experienced left thigh swelling and erythema. N 06/26/2001 06/26/2001 0 NONE PVT PUB NONE NONE 1
0172876 07/03/2001 MI 10.0 10 F 06/01/2001 24 hours post vax, the pt developed an itchy rash on back, chest, and arms. The pt also experienced a quarter sized swelling at the injection site. Pt treated with Benadryl. Y Y 05/29/2001 05/30/2001 1 NONE PUB PUB NONE NONE MI2001048 1
0172877 07/03/2001 MI 20.0 20 F 05/16/2001 The pt experienced flu-like symptoms, sore, swollen left arm, redness and a fever of 101 with chills. Y 05/14/2001 05/15/2001 1 PUB UNK Claritin, Singular MI2001047 1
0172878 07/03/2001 TX 12.0 12 M 05/10/2001 The pt experienced a fever of 104 the evening of the vax with nausea and vomiting. The next day a low grade temp was experienced. Y Y 02/09/2001 02/09/2001 0 instructed on how to treat symptoms PUB OTH NONE NONE ~Hib + Hep B (no brand name)~1~14.00~In Sibling TX01045 1
0172879 07/03/2001 TX 13.0 13 F 04/05/2001 One day post vax, the pt experienced malaise, nausea, decreased appetite, stomach cramps, symptoms would resolve and then start again. Mom took child to ER. The pt was dx with increased liver enzymes, probably secondary to Hep B vaccine. Released to home. Y Y 03/29/2001 03/30/2001 1 UA, Blood work, x-ray PUB PUB NONE NONE TX01040 1
0172880 07/03/2001 TX 5.0 5 M 04/05/2001 The pt experienced an injection site reaction which was hard and hot to touch with redness and pain. No fever was reported. The pt was treated with cool pack, Benadryl, Tylenol. Y Y 04/03/2001 04/04/2001 1 NONE PUB UNK NONE immune problem TX01041 1
0172881 07/03/2001 MI 23.0 23 F 06/15/2001 The pt experienced swollen lymph glands, purple like bumps, within 24 hours of vax. No fever was experienced, the pt was just uncomfortable. The bumps spread from arm to groin to knees. Swollen lymph nodes were under the arm. Y 06/12/2001 06/13/2001 1 NONE OTH PVT Allegra, Claritin, Advil, Triphasil, Atalan NONE allergy to sulpha 1
0172882 07/03/2001 NV 1.0 1 .0 F 06/25/2001 The pt experienced a cough, congestion, maculo-papular rash, no vesicles. U 06/14/2001 06/21/2001 7 CBC, WBC - 6600, P - 53, PVT PUB 1
0172883 07/03/2001 NH 1.0 1 .0 M 06/19/2001 The pt experienced a raised red area on neck, trunk, arms, and behind left ear. Y 04/11/1997 06/17/2001 1528 PVT UNK 1
0172884 07/03/2001 CO 33.0 33 F 06/09/2001 The pt experienced extreme diarrhea for 3 weeks plus. Given a prescription to control fever of 102. Y Y 05/05/2001 05/06/2001 1 lab tests - nml MIL MIL Prevacid acid reflux 1
0172885 07/03/2001 WA 1.3 1 .0 F 06/25/2001 The pt experienced herpes zoster on right arm with C-6 dermatome on 5/10/01. The pt was seen on 5/15/01, had a fever to 102 that day only. Lesions are healing. Symptoms are treated with acyclovir. Y Y 01/19/2001 05/10/2001 111 PVT OTH NONE NONE NONE 1
0172886 07/03/2001 OR 12.0 12 F 06/07/2001 The pt experienced an itchy rash on skin all over. No respiratory symptoms. Resolved with Benadryl. Y 05/17/2001 05/17/2001 0 NONE PUB PUB NONE NONE itchy rash~Hep B (Engerix-B)~2~11.00~In Patient 1
0172887 07/03/2001 IL 33.0 33 F 06/20/2001 The pt experienced a fever of 101-102, rash to left upper extremity and right wrist, joint pain and stiffness. Saw an MD on 6/19/01. Y 06/06/2001 06/12/2001 6 OTH OTH Albuterol, nebulizer treatments, Accolate, Nasonex, Pulmocort NONE asthma 1
0172888 07/05/2001 IL 0.25 0 .2 M 06/16/2001 The baby was found dead in the crib. Autopsy report states death due to myocarditis. Y 06/15/2001 N 06/05/2001 06/15/2001 10 PVT PVT NONE URI NONE 1
0172898 07/05/2001 WA M 07/02/2001 Medical history, concurrent conditions and concomitant medications were not provided. On an unspecified date, in early May, 2001, the pt received his 3rd injection of Havrix and his 1st dose of Hep-B (Engerix-B, see report 20010157291). Three weeks later, he experienced unspecified neurological symptoms and subnormal temperatures. The vaccinee was seen by a physician, who suggested that the pt might be experiencing Guillain-Barre syndrome. The pt felt that his symptoms were possibly related to an unspecified sexually transmitted disease. This report is considered to be "Medically Serious". As of 6/27/01, the outcome of the event was unknown. F/U states the pt was seen by a neurologist. Nerve conduction studies were performed, which led to a dx of brachial plexitis. The pt stated that "other factors were involved" in the development of this event and that his symptoms were possibly related to an unspecified sexually transmitted disease or unspecified virus. The pt stated that his neurologist does not consider the brachial neuritis to be related to IZ. However, as a precaustion, the pt has elected to discontinue the Engerix-B IZ series. The most recent information received on 7/13/01, indicated that the brachial plexitis and subnormal temperatures were ongoing. Brachial plexitis is considered "Medically Serious". Y N 05/01/2001 05/21/2001 20 Nerve conduction studies-consistent with brachial plexitis OTH OTH 20010157292 1
0172899 07/05/2001 CO 20.0 20 M 06/27/2001 I began the Anthrax series as an active duty member of the Air Force on 8/11/99. The 2nd on 8/25/99, 3rd on 9/8/99 and the 4th on 2/8/00. Symptoms of Crohn's dx'd in 4/00, began in 9/99. Y N 08/11/1999 09/01/1999 21 Crohn's dx'd by Sig-flex, colonoscopy and upper barium MIL MIL IPPD/Pasteur Merieux/01549P/1 previously; discontinued Accutane in 8/99 NONE NONE 1
0172900 07/05/2001 MI 0.6 0 .6 M 06/29/2001 The second week following vax the patient developed a fever and episodes of staring. Three weeks post-vax patient had jerking at times, high pitched cries and squeals and wouldn't try to speak as before. Y Y 03/22/2001 03/30/2001 8 UNK PUB PUB NONE NONE NONE 1
0172901 07/05/2001 WV 3.0 3 F 06/27/2001 The patient developed a rash on the same day as the vaccine. Patient was treated with Benadryl for 2 days. Y Y 06/27/2001 06/27/2001 0 PVT PUB NONE NONE Allergy to Amoxicillin 1
0172902 07/05/2001 OH 1.25 1 .3 F 06/26/2001 Following vax, patient was crying and developed a fever of 102F. Patient has a red area, approx. the size of a dime, at the injection site. ER doctor prescribed Motrin. The follow up confirmed site was at left upper thigh site Varivax-no other AE. Hx no other vaccination previous 4 weeks. Y Y 06/21/2001 06/21/2001 0 NONE PUB OTH NONE UNK NONE 1
0172903 07/05/2001 TN 0.3 0 .4 F 06/18/2001 Three days post-vax the patient ran a fever of 104.7F and was irritable. The patient did not sleep well for 2-3 more days. Y Y 10/17/2000 10/20/2000 3 PUB PUB NONE NONE TN01026 1
0172904 07/05/2001 TX 2.0 2 .4 F 06/29/2001 Right leg red warm and swollen with raised area 9mm X 8mm wide. Area noted at approximately 6pm on 6/13/01. Doctor gave pt benadryl and applied cold compresses. Leg free of S&S of adverse reactions on 6/14/01 reports pt's mother. Y Y 06/11/2001 06/13/2001 2 NONE PUB PUB NONE NONE Premature by weight 1
0172905 07/05/2001 KY 1.25 1 .3 F 06/27/2001 Pt was vaccinated approximately 9:30am without difficulty and well tolerated. acetaminophen given prior to vaccine and again at 7:30pm. Temp taken 8:00pm with reading of 103.1F approximately 8:30pm pt had the 1st grand mal seizure lasting for 2-3 minutes & the 2nd occurring in the car on the way to KDMC ER lasting 1.5 minutes. Tests run & spinal tap performed to rule out meningitis. Pt given A-Cillin and discharged. Y Y 06/19/2001 06/19/2001 0 Chest x-ray - WNL, CBC white blood count of 11, Hgb - 11.2, Hct - 31.9, electrolytes - WLN, urinalysis - WNL, Spinal Tap - no white blood,red blood cells. PUB PUB Prevnar/Lederle/477493/LLT/0 NONE NONE Significant for past hx w/heart murmur KY2001048 1
0172906 07/05/2001 KY 0.3 0 .4 M 06/28/2001 Vaccines given 6/20/01, the night of 6/20/01 pt screamed inconsolable for 3-4 hrs, temp 102.9F. In office next day for evaluation exam was negative temp 99.9F (ear). CBC all WNL Y Y 06/20/2001 06/20/2001 0 CBC - WNL PVT UNK none none KY2001047 1
0172907 07/05/2001 CA 50.0 M 06/25/2001 After about 2nd vaccine, started to notice migrating polyarthralgia comes and goes. Has recurrent rash at one area inner R elbow. N RF, Lymes Titer PVT PVT NONE 1
0172908 07/05/2001 MD 38.0 36 F 07/02/2001 Joint Pain, Soreness at the injection site: Report 2001015472-1 described joint pain in a pt who rec'd Lyme disease vaccine recombinant OspA (Lymerix) for the prevention of Lyme disease. This report was rec'd from the vaccines and has not been verified by a physician or other HCP. Reportedly, the pt had no known drug allergies. Per medical history included psoriasis,. The pt did not have gout or Crohn's disease. Pt had no history of Lyme disease. There was no family history of rheumatoid arthritis or lupus. She rec'd birth control medication (NOS). In 9/99, the pt rec'd her 1st Lymerix L arm, within 24 hrs post vaccine, the injection site was very sore. Her arm was difficult to move. In approximately 1/00, she reportedly began experiencing R hip soreness, bilateral knee problems of soreness and grinding noise and bilateral elbow soreness. She stated that none of her joints have been swollen, warm or red. The pt stated that her joint complaints have not been evaluated by a physician, and she has not rec'd any medical treatment for the joint pain. As of 6/27/01, her joint pt was getting worse. The outcome of the soreness at the injection site was not specified. The adverse event of joint pain does not meet ICH serious criteria, but is being submitted as an expedited report by special FDA per the 6/28/00 letter. N 09/01/1999 01/01/2000 122 PVT PVT birth control Psoriasis - reportedly, the pt had NKA. Her medical history included psoriasis. The pt did not have gout, or Crohn's disease. She had no history of Lyme disease. There was no family history of RA or lupus. She rec'd birth control medication (NOS) 20010154721 1
0172909 07/05/2001 KY 71.0 71 F 10/09/2001 Foggy headed (confusion), felt cold, leg pain, low pulse rate, maladministration (above recommended age), tired, weak - report 2001015290-1 described foggy headedness in a pt who rec'd Lyme disease vaccine recombinant OspA (Lymerix) for the prevention of Lyme disease. This report was rec'd from the pt and has not been verified by a physician or other HCP. Reportedly, the pt is allergic to all narcotics and to Robaxol. Reportedly she has had arrhythmia's (NOS) for approximately 5 years which were treated with metoprolol (Toprol XL). On 5/31/01, the pt rec'd her 1st dose of Lymerix, she was above the maximum recommended age for immunization. Subsequently, on 5/31/01 she reportedly felt weak and tired. On 6/1/01, reported, she experienced extreme fatigue and felt cold to the bone. The fatigue and coldness persisted on 6/2/01, and she then experienced leg pains and a low pulse rate (50-52 beats per min) all day. She contacted her physician who reportedly feels all adverse events (were) related to vaccine. On 6/3/01, all symptoms continued and she reported that she began feeling very foggy headed. On 6/4/01, she reportedly started to feel better. However, her symptoms did not completely resolve for approximately 2 wks after the vaccine was administered. As of 6/20/01, the adverse events had resolved. The adverse event of foggy headedness does not meet ICH serious criteria, but is being submitted as an expedited report by special FDA request per the 6/28/00 letter. The follow up states that the vaccinee was allergic to "all" narcotics, to Robaxil, and to sulfa. Her medical history included hysterectomy, upper back mass NOS, osteoporosis and plantar fasciitis. She received montelukast sodium. On 05/23/2001, the vaccinee received her first .5cc right deltoid dose of LYMErix; she was above the maximum recommended age for immunization. When seen by the physician on 05/23/2001, she complained of a sore right heel and a tick bite. She had a macular rash on the thigh and right abdomen. Impression: rule out Lyme secondary to tick. Amoxicillin three times daily for three weeks was prescribed. Subsequently, on 05/31/2001, she reportedly felt weak and tired. On 06/01/2001, she experienced extreme fatigue and felt "cold to the bone." The fatigue and coldness persisted on 06/02/2001, and she then experienced leg pains and a low pulse rate all day. She contacted her physician, who reportedly "feels all adverse events were related to vaccine." On 06/03/2001, all her symptoms continued and she reported that she began "feeling very foggy headed." On 06/04/2001, she reportedly started to feel better. However, her symptoms did not completely resolve for approximately two weeks afterthe vaccine was administered. As of 06/20/2001, the adverse events had resolved. Y 05/23/2001 06/03/2001 11 PVT PVT Amoxil,Metoprolol, Singulair Allergic to Robaxol, allergic to narcotics, and sulfa, arrhythmia's, osteoporosis, systerectomy 20010152901 1
0172910 07/05/2001 WI 61.0 M 11/15/2001 Report 2001015262-1 described RA in a pt who rec'd Lyme disease vaccine recombinant OSPA (Lymerix) for the prevention of Lyme disease. This report was rec'd from the pt and has been verified by a physician or other HCP. The pt is allergic to penicillin. Reportedly, he has had colitis for 30 yrs, it was treated with sulfasalazine (Azulfidine). He did not have a history of Lyme disease. His brother had Crohn's disease and his grandfather had arthritis (NOS). In 8/01, the pt rec'd his 3rd dose of Lymerix. Six months later in 2/01, he reported experienced arthralgia's . He reportedly experienced pain in the shoulders traveling to the legs, hips, knees,and ankles. The pt was seen by an arthritis specialist. The pt reported that swollen shoulders, ankles, hips and knees were noted on physical exam. No warm joints were noted and no joint fluid was obtained. Unspecified lab analyses were performed. The pt reported that the specialist recently made a diagnosis of RA and does not feel the symptoms were related to Lymerix. The pt was treated with methotrexate daily (dose unk), Celecoxib (Celebrex) 200mg twice daily, and Prednisone 15mg daily. As of 6/25/01, the event was ongoing. The adverse event RA does not meet ICH serious criteria, but is being submitted as a expedited report by special FDA request per the 6/28/00 letter. The follow-up states that on 06/02/1999, 07/02/1999 and 05/31/2000, the vaccinee received his first, second, and third doses of LYMErix, respectively. On 09/12/2001, the physician stated that the MTP joints of feet were noted to be swollen on physical exam. No warm joints were noted on physical exam. No joint fluid was obtained. As of 09/12/2001, the outcome of the event was unknown. The most recent info was received from the rheumatologist on 11/14/2001. He wrote,"The pt is treated with methotrexate and prednisone for his rheumatoid arthritis which is currently well controlled. He is having no synovitis. His disease has been relatively stable recently." Y N 05/31/2000 02/01/2001 246 PVT PVT Azulfidine (Sulfasalazine) Allergic to penicillin, colitis, Crohn's Disease 20010152621 1
0172911 07/05/2001 MO 1.0 1 .0 M 07/02/2001 Patient developed a rash and cellulitis after receiving vax. Y 06/11/2001 06/26/2001 15 NONE PVT OTH NONE NONE NONE 1
0172912 07/05/2001 MA U 05/15/2001 Information has been received from a pharmacist concerning children a day care who were vaccinated with varicella virus vaccine live. Subsequently, there was a chicken pox outbreak at the day care. The pharmacist reported that many of the children were vaccinated with varicella virus vaccine live from the following lot numbers prior to the outbreak (lot#6229690423E, 6122141124B,6173130769D,6179110778D,6192731357D, and 6277481059H). The records of testing prior to release of the lots were checked by Biological Quality Assurance and found to be satisfactory. The lots comply with the standards of the Center for Biologics Evaluation and Research and was released. Additional information has been requested. Per F/U 6/18/02: There were 24 cases of chicken pox breakthrough at the day care. Additional information has been requested. U OTH OTH UNK UNK WAES01030289 1
0172913 07/05/2001 NY 62.0 62 F 06/18/2001 The day following vax the patient developed dull ache on posterior side to underarm going to shoulder. Patient states pain level is a 2. Patient states difficulty sleeping. Treated with Tylenol, but not effective. Y 06/13/2001 06/14/2001 1 NONE PUB PUB Lipitor NONE NONE 1
0172914 07/05/2001 MD 30.0 28 F 07/02/2001 Patient developed tingling sensation of thumb and 5th finger one hour post-vax. Y 07/02/2001 07/02/2001 0 OTH OTH Tricyclen, PPD NONE Polio, Scoliosis 1
0172915 07/05/2001 CA 1.0 1 .4 M 06/30/2001 The patient developed redness and swelling over the right shoulder the day after vax. U 06/28/2001 06/29/2001 1 PUB UNK Tylenol NONE Corny hemangioma right finger 1
0172916 07/05/2001 TN 23.0 23 M 06/18/2001 Post-vax patient lost consciousness for about 5-10 seconds. Patient appeared to have a partial seizure that lasted for one minute. Patient was very clammy and diaphoretic. After 10 minutes patient was semi-alert and follows simple commands. Patient more alert and oriented after 30 minutes and was transported to the hospital by EMS. Y Y 06/14/2001 06/14/2001 0 Test performed at the ER and everything was normal. OTH OTH NONE NONE NONE TN01025 1
0172917 07/05/2001 CO 1.0 1 .0 F 06/28/2001 About 12 days post-vax, patient developed erythema multiforme, fever and vomiting lasting 24 hours. Y 06/14/2001 06/26/2001 12 PVT UNK 1
0172918 07/05/2001 MD 36.0 36 F 06/26/2001 Day after vaccination the patient woke with a rash, fever, cough and congestion. The patient was treated with Medrol PR. On 6/21/2001 the patient experienced shortness of breath and worsening of rash, fever, cough and congestion due to vaccine. The patient reported no relief from Medrol Pack. Y Y 06/13/2001 06/15/2001 2 PUB UNK NONE NONE NONE 1
0172919 07/05/2001 MI 27.0 27 F Patient experienced malaise, LAD and sore throat for 2 days post-vax. 04/16/2001 04/25/2001 9 CBC was normal 4/27/2001 PVT PVT NONE NONE NONE 1
0172920 07/05/2001 OH 1.25 1 .3 M 06/25/2001 Patient experienced congestion, spots and a fever of 104F as reaction to having MMR. Y 01/05/2001 01/13/2001 8 PUB PUB NONE NONE NONE 1
0172921 07/05/2001 VA 5.0 5 F 06/27/2001 Patient experienced scattered lesions on the upper extremities, chest and upper back. Patient had pruritus with a lesion at the corner of her mouth. Y 06/09/1999 06/02/2001 724 NONE PVT PVT NONE NONE 1995 Pacemaker insertion-removal 1999 1
0172922 07/05/2001 MA 1.5 1 .6 M 06/28/2001 Within 15 min of vax a small wheal appeared around injection site. Then sever wheals appeared just under injection site. 24 hours later the pt developed erythema with increased warmth around site. The pt was diagnosed with allergic reaction. Treated with Benadryl Y Y 06/25/2001 06/25/2001 0 PVT PUB NONE NONE asthma, GERD 1
0172923 07/05/2001 MD 23.0 23 F 06/28/2001 headache, myalgia and fatigue Y Y 06/25/2001 06/26/2001 1 NONE PVT PVT NONE NONE NONE 1
0172924 07/05/2001 CT 1.0 1 .0 F 06/27/2001 The patient experienced a vesiculo papular rash with 50-75 lesions eight days after the vaccination. The rash lasted 5 days. The patients fever was 102-103.5F daily 7, 8, and 9 days after immunization. Irritability was still present 16 days after immunization despite rash and fever resolution. Y 05/30/2001 06/07/2001 8 NONE PVT PVT NONE NONE NONE ~Measles + Mumps + Rubella (no brand name)~1~1.00~In Sibling 1
0172925 07/05/2001 LA 3.0 1 .2 F 06/25/2001 Patient developed shingles 06/05/2001. Y Y 05/13/1999 06/05/2001 754 NONE PVT PVT NONE NONE NONE 1
0172926 07/05/2001 CA 1.0 1 .1 F The patient developed ileocolic intussusception. The patient was treated with contrast enema and completely reduced by 6/19/2001. Y Y 06/15/2001 06/18/2001 3 PVT PUB Amoxicillin Otitis 1
0172927 07/05/2001 MO 5.0 5 F 06/28/2001 The pt experienced a fever of 106, limpness, headache, dizziness, and eyes rolling. This started approximately 2 hours post vax. The 2nd episode 10 hours later and then was sent to a local hospital. Y Y 06/27/2001 06/27/2001 0 PVT PVT NONE NONE 1
0172928 07/05/2001 IL 23.0 23 F 06/21/2001 The pt experienced a sore throat and fever with an onset of patchy vesicular rash. N 06/12/2001 06/16/2001 4 PUB PUB NONE 1
0172929 07/05/2001 WI 10.0 10 F 06/25/2001 The pt experienced a white bumpy rash which itched for a short time and then hurt and then started to swell and turn red, hot, the size of a silver dollar. The pt was seen by an MD who did not feel this was a reaction to the vax, feels was a bug bite reaction. Y N 06/13/2001 06/24/2001 11 NONE PUB PUB NONE NONE NONE 1
0172930 07/05/2001 PA 1.0 1 .0 M 06/22/2001 10-11 days post vax the pt experienced a fever for 2 days, and then severe body rash with several vesicles and extreme lethargy with anorexia for 3 days. Treated with Advil and monitoring. Y Y 05/14/2001 05/22/2001 8 PVT PVT Advil NONE NONE 1
0172931 07/05/2001 LA 6.0 M 06/25/2001 Child developed shingles on left hand and arm on 5/23/01. Y Y NONE PVT PVT NONE NONE NONE 1
0172932 07/05/2001 NY 0.2 0 .2 F 06/27/2001 Inconsolable crying and decreased level of alertness. Y 04/04/2001 04/04/2001 0 NONE PVT PVT NONE NONE 1
0172933 07/05/2001 MT 17.0 17 M 06/22/2001 The pt experienced hives to the bilateral inner forearms and palms of both hands. This occurred approximately 3 hours post vax. Treated with Benadryl, Zyrtec. Y 06/21/2001 06/21/2001 0 OTH OTH OTC NONE allergy to cats and hayfever 1
0172934 07/05/2001 NJ 6.0 6 F 06/26/2001 Full blown varicella with >100 pox marks, 19 days, post vax. Had a low-grade temperature. Rx'd with Zovirax 300mg po every 6 hours X 5 days. Y 06/07/2001 06/25/2001 18 NONE PVT PVT NONE NONE 1
0172935 07/05/2001 WI 46.0 46 F 06/28/2001 Reported mild headache, joint pain and diarrhea today. U 06/27/2001 06/28/2001 1 PUB UNK Premarin, Zoloft, Synthroid, Vioxx NONE Sulfa medications 1
0172936 07/05/2001 NY 18.0 18 M 06/28/2001 Grand mal seizure for 45 seconds and 30 minutes post-ictal. First seizure. Obviously no proof of causality. Y Y 06/19/2001 06/21/2001 2 PVT PVT Lisinopril 20mg QD NONE Hypertension 1
0172937 07/05/2001 KS 38.0 38 M After 20 minutes, pt complained of dry, swelling in roof of mouth, dry throat making it difficult to swallow. BP 134/100, P-68, T-98.4F. No SOB or other difficulties breathing. Observed for a total of 45-60 minutes. No edema of roof of mouth or uvula or throat observed. Y 06/28/2001 06/28/2001 0 PUB PUB diltiazem 240mg daily, Pepcid (OTC) prn NONE Printers ink allergy; hypertension 1
0172938 07/05/2001 NC 2.0 1 .4 F 06/28/2001 Pt developed chickenpox (vesicles and scabs) after varicella vaccine. Y 08/29/2000 06/28/2001 303 PVT PUB Cardiac murmur 1
0172939 07/05/2001 NY 15.0 15 M 06/28/2001 Pt developed soreness in arm, agitation and anxiety attack within hours of shot. Pt otherwise calm and relaxed. Pt stated he felt "weird." Y 06/28/2001 06/28/2001 0 PVT PVT NONE 1
0172940 07/05/2001 CA 26.0 26 M 06/29/2001 Injection site cellulitis left arm developed 1 week after vaccine administration, requiring oral cephalexin. Patient seen at regular intervals (06/27/2001, 06/29/2001,..) 06/16/2001 06/23/2001 7 Above vaccine given as required per immigration physical PVT PVT NONE positive ppd status NKDA 1
0172941 07/05/2001 CA 5.0 5 M 06/20/2001 Left deltoid area, pain, swelling, warmth, indiration, itchiness, and tenderness Y Y 06/12/2001 06/13/2001 1 NONE PVT OTH given prednosine, andrypthydroxyzine for reaction NONE NONE 1
0172942 07/05/2001 FL 6.0 6 M 06/26/2001 Mom states that child had shots 06/22/01. Rash appeared 06/24/2001 states rash comes and goes- child itches a lot. Seen in clinic 06/25/01- 3pm rash noted on face and trunk - child states he itches a lot. Seen by Dr- mom states he has an appointment in one week. Y 06/22/2001 06/25/2001 3 PUB PUB NONE NONE Seizure~Measles + Mumps + Rubella (MMR II)~1~2.00~Patient 1
0172943 07/05/2001 MT 1.7 1 .7 M 06/26/2001 9 days after receiving varicella and mmr injections, pt had onset of hives under right arm and left groin area; these became generalized over body. no fever, taken to prompt care, given zyrtec. hives lasted 3 days. 11 days after hives appeared, pt had 8 pox, followed by spontaneous recovery. Y Y 05/22/2001 05/31/2001 9 NONE PUB PUB NONE NONE NONE 1
0172949 07/05/2001 OH 0.3 0 .3 M 01/26/2000 Diarrhea - A report was received from Wyeth (8-99130-003A) regarding events in Ohio. A territory representative reported that an infant received the first dose of Rota Shield and, later that evening, developed mild diarrhea which resolved the same evening. Follow-up information received from the infant's mother indicated that her 4 month old son received Roth Shield, DTaP (Wyeth-Lederle), Hib (Wyeth-Lederle) and IPV (PMC France) vaccines in January 1999. Within 24 hours, the infant developed diarrhea. He recovered. No additional information was provided with correspondence returned to Aventis Pasteur US on 19 Jan 2000. From follow up #2 correspondene received on 12/10/01 it was reported that the pt received the vaccinations on 1/29/99. No treatment was required. The pt recovered from this experience and is healthy. The lot numbers and the route/site info for the products were also provided. No further info is expected, this case is closed. Y 01/29/1999 01/29/1999 0 UNK PVT OTH NONE UNK U199901056 1
0172952 07/05/2001 FL 0.3 0 .2 M 01/26/2000 A Physician reports that after vaccinations in June 1999, his pt had flecks of blood in his stools. On week post immunization his stools became mucousy. Three weeks post immunization, his stools were completely mucous. The pt became irritable and crampy before passing each stool. The child was entirely breast fed. The Dr instructed the the mother to begin feeding the child with Nutramigen, but no change in stools occurred. Slimy stools persisted as of 07/19/1999. The Dr diagnosed possible colitis. U 06/01/1999 06/01/1999 0 NONE PVT OTH NONE UNK 01999010870 1
0172956 07/05/2001 PA 1.4 1 .5 M 02/24/2000 The pt received his vaccinations on 12/09/99 and within 24 hours he developed an injection site reaction with redness, warmth and swelling. Upon internal review it is deemed necessary to amend the latest received dte for this report to read correspondence received on 11/16/01. This case is closed. Y 12/09/1999 UNK PVT PVT UNK UNK U2000000600 1
0172961 07/05/2001 KY 5.0 5 F 03/31/2000 It was reported that a 5 year old female received on IPOL vaccination on 3/13/00 and that same day, the pt developed a 20mm area of redness at the site of injection. From correspondence received on 3/30/00, it was reported that the pt also received DTAP Acel-Imune (Lederle) and MMR (Merck) on 3/13/00. The pt reportedly recovered from this experience. Additional pt, vaccine and responsible physician information was also provided. Y 03/13/2000 03/13/2000 0 PVT PVT Right serous otitis Perennial allergic rhinosinusitis U2000001370 1
0172964 07/05/2001 VA 4.0 4 M 05/03/2000 On 04/13/2000 post-vax, the patient developed a local reaction of 5cm of swelling. A physician evaluated the patient. From correspondence received from Aventis Pasteur on 05/02/2000, additional patient, vaccine and responsible physician information was provided. U 04/11/2000 04/13/2000 2 PVT PVT NONE 02000002740 1
0172965 07/05/2001 NY 1.5 1 .5 F 05/15/2000 Post vaccination the patient developed atrophy at the injection site. Information received 05/12/2000 states the patient's parents noticed a smooth indentation in the outer right thigh area, at or lateral to the site where the IPV was given. The site never scabbed, and remained red, swollen, blistered and tender. U 03/15/2000 NONE PVT PVT Acute serous otitis Colds, croup, ear infections 02000002950 1
0172967 07/05/2001 CA 0.3 0 .3 F 06/15/2000 Approximately one week after the vaccination the patient developed a lump at the injection site. U 02/08/2000 PVT PVT NONE 02000003570 1
0172968 07/05/2001 NM 0.4 0 .4 M 07/11/2000 On 05/10/2000 the patient developed a sterile abscess of his left thigh. The patient was treated at the hospital IND and packing, culture - sterile. On 06/12/2000 the patient developed a sterile abscess of his right thigh. The culture was lost at the lab. The patient was treated with Augmentin. Further information has been requested. Y U 04/12/2000 05/10/2000 28 UNK UNK U2000005290 1
0172969 07/05/2001 MI 1.3 1 .3 F 07/11/2000 Within 24 hours post-vax, the patient developed a local area of redness and swelling at the injection site. Further information was requested. U 06/20/2000 UNK UNK 0200000532 1
0172972 07/05/2001 TX 1.25 1 .3 F 11/22/2000 Pt developed fever of 102-103 and an injection site reaction characterized by a large knot, redness and warmth. Pt favored left leg while walking. Reportedly, pt recovered from this experience. As of 2/14/00, no further info was available. This case is closed. Y 02/07/2000 02/07/2000 0 UNK PVT PVT NONE NONE U2000005590 1
0172976 07/05/2001 SC 0.25 0 .3 F 10/12/2000 At 3:30pm the same day of the vaccination, the patient developed marked swelling at the injection site with a rash on her abdomen and unconsolable crying. The patient recovered. Y 08/30/2000 08/30/2000 0 PVT PUB NONE NONE U2000007270 1
0172977 07/05/2001 CA 1.3 1 .4 M 11/07/2000 After receiving vaccination the pt developed cellulitis at the injection site. Y 09/11/2000 UNK UNK U200000801 1
0172978 07/05/2001 CA 1.3 1 .4 F 11/07/2000 Sometime after vaccination the pt developed a local reaction of redness and swelling as well as vomiting. 09/11/2000 UNK UNK 02000008020 1
0172979 07/05/2001 CA 0.2 0 .2 F 01/27/2001 The same day of vaccinations the pt developed a temperature of 101F and a hard bump at the site of the injection. Y 08/25/2000 08/25/2000 0 Blood culture negative, CRP negative, CBC negative PVT PVT NONE NONE 02000008160 1
0172980 07/05/2001 TX 0.3 0 .3 F 11/22/2000 On the same day of vaccinations the pt developed a fever of 102 to 103 degree F and an injection site reaction. The pt's mother reported that the child cried very painfully after injection was given for 1-2 hours. Y 02/08/2000 02/08/2000 0 UNK PVT PVT NONE NONE U2000008490 1
0172981 07/05/2001 0.08 U 01/17/2001 After receiving vaccinations, a6 week old pt developed persistant crying and irritability. U 10/12/2000 UNK UNK 0200100760 1
0172982 07/05/2001 U 01/17/2001 Following the vax, the pt developed persistent crying and irritability. No specifics provided. Further information is requested. U 10/12/2000 UNK UNK U2001000770 1
0172985 07/06/2001 WI 0.3 0 .3 F 06/18/2001 Found dead/possible SIDS. Autopsy pending. When found baby was still warm. Tried CPR to no avail. Autopsy report states final anatomic diagnoses: hemorrhges, lungs; s/p ligaton of patent ductus arteriosus; umbilical hernia, small. Death certificate states cause of death to be SIDS. Y 06/13/2001 N 06/11/2001 06/13/2001 2 Autopsy pending PVT OTH NONE NONE Prematurity; Apnea and Bradycardia 1
0173007 07/06/2001 FL 1.4 1 .4 F 06/25/2001 The week after receiving vaccine, the pt had three molars come in which coincided with joint pain in knees and hips. On day 10, 5/21/01, she couldn't stand or extend her knees. Her temperature was 101.6 which only lasted a few hours. She was seen by MD who order Advil every 5-6 hours. As of 5/29/01, she still could not bend over to pick things up, but she was able to walk with gait difficulty. It was noted that her knees and hips seem to be the only joints affected and that she was going to see the MD again on 5/30/01. Additional info received from pharmacist indicated that the pt was diagnosed with discitis upon further evaluation and MRI. It was reported that the MD feels confident that this experience was not related to the vaccination. The pt is now receiving a 6-week course of antibiotics and is "doing better." Upon internal review the pt's discitis was considered to be an other important medical event. Addtl info has been requested. Y N 05/11/2001 05/18/2001 7 MRI-discitis OTH OTH UNK NONE WAES01052716 1
0173008 07/06/2001 1.08 1 .1 M 06/25/2001 In March 1993, pt experienced repetitive behavior and playing without imagination. In June and July 1993 the pt experienced lack of communication. In October 1993, the pt experienced flu and vomiting. In December 1992 the pt experienced echolalic speech, lack of bowel control, and chronic soiling. The pt experienced upper respiratory tract infection in February 1994, September 1994, October 1994, November 1994, February 1995 and June 1995. In December 1994 pt experienced temperature, earache and diarrhea. In July 1995, pt experienced enteritis. The pt also experienced chronic constipation. Autism was diagnosed in 1996. The autism was considered a significant medical event. No further info is available. N 01/27/1993 03/01/1993 33 OTH OTH UNK UNK WAES99031877 1
0173009 07/06/2001 MO 68.0 68 M 03/28/2002 On 6/8/01, 1 day post vaccine, the pt developed redness and swelling at the injection site and was admitted to the hospital with cellulitis. The MD reported that 3 other pts had received vaccinations from the same vial w/out incident. Cultures done were positive for infection. As of 6/12/01, the pt remained hospitalized. On 6/14/01, the MD reported that there was only 1 positive blood culture (previously reported as 2) showing bacterial growth. As the growth was now identified as coagulase negative staph aureus and the concurrent WBC count was only 5.300, this was regarded as a contaminant. Therefore, there are no positive blood cultures. It was reported that the pt was discharged from the hospital and was placed on oral cephalexin (Keflex). The reporter expressed a concern with the lot #. The records of testing prior to release of this lot have been checked by Biological Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Addtl info has been requested. Follow-up info indicated that the pt was hospitalized from 06/08/2001 until 06/13/2001 with a discharge diagnosis of cellulitis. Subsequently the pt recovered. It was reported that the physician was not convinced that the pt's diagnosis was associated with pneumococcal vaccine 23 polyvalent. No further info is available. Y 5 Y 06/07/2001 06/08/2001 1 Diagnostic lab test-coagulase negative staph aureus; WBC count-5.300 regarded as a contaminant OTH OTH albuterol, Norvasc, aspirin, Vasotec, Imdur, Mag-Ox 400, Megace, metoprolol, K-Dur, Zocor, Azmacort Alcoholism, impaired immune system, malnutrition, iodine allergy, emphysema WAES01061040 1
0173012 07/06/2001 WA 0.4 0 .4 M 06/25/2001 On 7/12/99, 4 days post vaccine, the pt experienced acute asthma attack. He was hospitalized and administered standard asthma care for 9 days. He did well in the hospital and was discharged home w/out complications. The reporting investigator felt that acute asthma attack was possibly related to study therapy. No further info is available. Y 10 N 07/08/1999 07/12/1999 4 PVT OTH UNK WAES01061489 1
0173013 07/06/2001 WA 0.3 0 .4 M 06/25/2001 On 4/28/00, 4 days post vaccination, pt experienced greater than 20 myoclonic jerks during the day and was hospitalized for 1 day. There was no cyanosis. It was reported that the patient had microcephalopathy and status encephalopathy. Subsequently the pt recovered. The microcephalopathy and status encephalopathy were considered significant medical events. The reporting investigator felt that the events were possibly related to study therapy. No further info is available. Y 1 Y 04/24/2000 04/28/2000 4 PVT OTH UNK WAES01061488 1
0173015 07/06/2001 GA 1.4 1 .1 F 07/03/2001 On the evening of 3/6/01, pt developed a temperature of 104.6 and difficulty breathing. Y Y 03/06/2001 03/06/2001 0 PVT UNK NONE NONE 1
0173016 07/06/2001 IL 1.0 1 .0 F Red macular rash over entire body and face. No vesicles, no papules. Had pruritus and also a low-grade fever and URI symptoms, rhinorrhea. Had 1 day of fever and rash, then better. Treated with Benadryl. Y 06/11/2001 06/12/2001 1 NONE OTH PUB NONE NONE NONE 1
0173017 07/06/2001 ND 1.0 1 .0 F 06/26/2001 On 6/25/01, pt had generalized tonic/clonic seizure with temperature of 102F. No other source of temperature other than recent vaccine. Y Y 06/18/2001 06/25/2001 7 CBC-nml; electrolytes-nml PVT UNK NONE NONE 1
0173018 07/06/2001 NM 2.0 2 .7 F 06/28/2001 Local redness, pain, low-grade fever, induration that cleared on 6/24/01. Y 06/21/2001 06/22/2001 1 PVT PVT NONE NONE 1
0173019 07/06/2001 NM 1.25 1 .3 M 06/28/2001 Local redness, pain, low-grade fever, induration that cleared on 6/24/01. Y 06/21/2001 06/22/2001 1 PVT PUB NONE ~Vaccine not specified (no brand name)~~0.00~In Sibling 1
0173020 07/06/2001 OK 0.5 0 .5 F 06/26/2001 Pt was taken to the ER at 1 AM the day post vax with a fever of 105. Fever lasted until that evening at 8:30 PM. Pt was treated with 2 shots of Rocephin IM. Y Y 06/15/2001 06/16/2001 1 Chest X-ray; WBC-elevated PUB OTH 1
0173021 07/06/2001 CA 1.0 1 .1 M 06/29/2001 Child developed crops of small papules with occasional small vesicular lesions on the trunk and extremities, the day after immunizations were given. Denies any fever. Child is irritable at times, itchy. Mom reports that he is eating, drinking and playing intermittently. Pt was given Benadryl by mouth while at the clinic which he had to continue every 6 hours for the next 5-7 days on recheck. Mom advised to seek medical help at ER as needed over the weekend and at office. Otherwise, will recheck him in 4-5 days. Y U 06/27/2001 06/28/2001 1 PUB UNK NONE NONE 1
0173022 07/06/2001 NE 0.2 0 .2 M 06/25/2001 Pt developed increased sleepiness w/in hours post vax. He had no signs or symptoms of infection. Sleepiness lasted about 24 hrs. Y U 06/22/2001 06/22/2001 0 NONE PVT OTH NONE Status post nephrectomy for mesoblastic nephroma 1
0173023 07/06/2001 UT 0.4 0 .4 F 06/21/2001 On 6/21/01 at 11:30 AM, immunizations given. "Red bumps", per mom, on back, head and neck as soon as left, post vax. Progressed to around nose and mouth with red bumps. Went to doctor about noon. On Friday, 6/22/01, red rash spread to back and tummy. Went to doctor and was given Benadryl. On 6/24/01, red rash not going away, 1/2 dollar-sized induration (proximal lvl). Gave prednisone. On 6/26/01, no signs or symptoms of red rash and no complaint of breathing problems. No SOB. Had 5mm induration (proximal lvl). No other signs, symptoms or other complaints. Y Y 06/21/2001 06/21/2001 0 NONE PUB PUB NONE NONE NONE 1
0173024 07/06/2001 NY 0.75 0 .8 M 06/27/2001 Left thigh cellulitis at site of DTAP injection. Mother reports that normal/usual skin prep was done before injection. Clinical exam; there was an expanding area of erythema, edema, tenderness and warm to touch. Clinical dx cellulitis. Pt given oral antibiotics. Y 06/25/2001 06/26/2001 1 MIL MIL NONE NONE 1
0173025 07/06/2001 OR 1.0 F Pt developed fever and jerking of extremities within 24 hours post vax. U 06/01/2001 06/02/2001 1 NONE UNK UNK NONE NONE 1
0173026 07/06/2001 MD 40.0 38 M 10/25/2001 In September 1999, pt recvd first dose of Lymerix. Within 24 hrs post vax, he experienced soreness at the injection site. In the Spring of 2000, he began experiencing "burning" in his knee joints. He was scheduled to be seen by a healthcare professional on 6/27/01. He had not yet recvd any medical tx for the knee discomfort. As of 6/27/01, the burning sensation in the knee joints was ongoing. The outcome of the soreness at the injection site was not specified. The adverse event of "burning in the knee joints" does not meet ICH serious criteria but is being submitted as an expedited report by special FDA request. The follow-up info received on 10/11/2001 states that the physician did not confirm the injection site soreness. In May 2000, he was seen by the vaccine provider, who noted swollen and warm knee joints on physical examination. It was not specified if joint fluid was obtained. Erythrocyte sedimentation rate, measured on an unspecified date, was 1mm/hr. Antinuclear antibody titer was measured on an unspecified date; results were not available as of 10/11/2001. An unspecified Lyme test date performed was negative. The vaccie provider considered the burning pain in the knee joints to be mild in intensity and possibly related to LYMErix administration. The joint symptoms resolved in October 2001. Y Y 09/01/1999 09/02/1999 1 PVT PVT Cozaar, Prilosec Hypertension, seasonal allergies 20010155061 1
0173027 07/06/2001 OR 36.0 34 F 06/21/2001 Approximately 1 year after last Anthrax shot, pt developed soreness at injection site. Pt had soreness to the touch and when moving arm in certain directions. N 02/04/2000 01/15/2001 346 MIL MIL Levoxyl NONE NONE 1
0173028 07/06/2001 VA 16.0 16 M 06/26/2001 Complaining of tingling and weakness in right arm and right leg X 1 week. Equal strength assessed bilaterally in all extremities. Has been taking Rabana BID (4 tsp in last week). This is a wine derivative from radishes in a foreign country. U 06/18/2001 06/18/2001 0 NONE PUB PUB Rabano NONE NONE VA01020 1
0173029 07/06/2001 NC 4.8 4 F 06/25/2001 Pt's right deltoid became hot, red and swollen to size of "orange" per mother one day post vax. Pt taken to Urgent Care and MD said it looked like a cellulitis and gave her IV antibiotics to cover "staph" infection. Pt seen on Monday and was on Augmentin. The site was warm, pink, nontender and slightly edematous. MD thinks it may have been a local allergic rx. Site never was tender but did itch on 6/22. No pustule at injection site. Y Y 06/21/2001 06/22/2001 1 NONE PVT PUB NONE NONE NONE NC01057 1
0173030 07/06/2001 MI 41.0 41 F 06/29/2001 Vaccines given on 6/23/01. Pt states left buttock turned red with itching at site and generalized body itching 2 days post vax. Pt states that cleared up in 2 days, at which time right buttock turned red around injection site which remains pink and raised rash today on 6/29/01. Afebrile. Y 06/22/2001 06/24/2001 2 Antibody titers drawn on all 4 vaccines on 6/29/01 PVT OTH NONE Scleraderma 1994 1
0173031 07/06/2001 CA 25.0 25 F 06/19/2001 Reaction noted on 6/15/01 as an area of swelling, redness and warmth. No treatment was given. The swelling was gone by 6/19/01. Redness (3cm diameter) was still present. U 06/14/2001 06/15/2001 1 NONE PVT PVT NONE NONE NONE 1
0173032 07/06/2001 IN 78.0 78 F Pt developed a 3 cm region of induration and redness. U 06/13/2001 06/17/2001 4 PVT PVT NONE NONE 1
0173033 07/06/2001 FL 4.0 4 F 06/19/2001 Child healthy. Family denied any known allergies. Pre-kindergarten physical and MMRII, DTAP, Varivax, and IPV given. Approx. 10 minutes, post vax, child became red, eyes and lips swollen, wheezing and coughing. PO Benadryl was given. BP-108/66, R-16. 911 called and EMTS took child to ER, awake, alert and able to speak. Y U 06/19/2001 06/19/2001 0 PVT PUB Unilateral kidney 1
0173034 07/06/2001 NH 4.0 0 .2 M 06/16/2001 No data recorded. Y 02/27/1997 PVT PUB 28 week prematurity, chronic otitis, hearing loss, WARI 1
0173035 07/06/2001 NC 26.0 26 M 06/07/2001 Elevated temperature up to 102 F. Pt felt like he was going to pass out and was a little nauseous. Y 06/06/2001 06/06/2001 0 UNK UNK 1
0173036 07/06/2001 DC 22.0 22 F 06/13/2001 Urticarial type rash on face, chest and back Y 06/12/2001 06/13/2001 1 OTH PUB Mefloqune 250mg occasional eczema 1
0173037 07/06/2001 65.0 F 06/27/2001 Pt inadvertently given Tetanus Toxoid Absorbed Purogenated vaccine that was not stored in refrigeration for 3 mos (storage requirements for this product are refrigeration at 2-8 degrees C). The pt experienced symptoms which included: chills, right arm warmth, pain, swelling and redness up to her neck, right arm lymph node swelling and severe muscle pain in leg, veins and body. U 06/11/2001 06/13/2001 2 UNK UNK 0115000203 1
0173038 07/06/2001 IN 1.0 F 06/27/2001 Pt developed ataxia after Varicella injection. Intention tremor, and worsening problems with loosing her balance. She initially had an upper respiratory tract infection with croup symptoms about 4 days prior to the onset of ataxia. Fever 102.7F, tremor Y N CT- negative,rapid strep screen - positive, MRI Normal, Urine tox screen -negative. VMA and HVA WNL, Urine analysis was Negative, WBC was 17,000, hemoglobin of 12.4, hematocrit 36.7, platelets 365,000, Pyruvate acid was normal, the rest of the chemistries were unremarkable. spinal tap normal PUB UNK 1
0173039 07/09/2001 0.25 0 .7 F 07/05/2001 A physician reported that a 2 month old female received Prevnar, Hib-Titer, Infanrix, IPV and Recombivax-HB vaccines on 9/15/00 as part of a study. On 10/14/00, at the age of 3 months, the child died. The cause of death was presumed to be Sudden Infant Death Syndrome. Both the medical monitor and the investigator agree that Sudden Infant Death Syndrome is not related to vaccine administration. Follow-up information received on 6/22/01, indicated that an autopsy revealed the cause of death as Sudden Infant Death Syndrome. The original assessment remained the same. Y 10/14/2000 N 09/15/2000 10/14/2000 29 Autopsy-SIDS UNK UNK UNK HQ3879417NOV2000 1
0173040 07/09/2001 MI 58.0 M 07/03/2001 Post vaccination pt presented with mental status changes and oliguria following a several day history of feeling fatigued. He also had a rash on his shins. He was admitted to the hospital approximately 2 weeks post immunization. He was afebrile but tachycardic. PE showed flaccid paralysis, decreased deep tendon reflexes and bilateral Babinski signs. A petechial rash was noted on both shins. The event was managed with plasmapheresis and hemodialysis. The pt has since recovered. It was noted that "it is likely that the influenza vaccine triggered the antibody formation and immune complex deposition and led to the development of TTP." Y Y Hemoglobin-11.7; blood lactate dehydrogenase-inc; platelet count-13000 cells/mm3; BUN and serum creatinine-inc; ANA-1:160 titer; non-drug dependent IgM pos; all other laboratory/diagnostic tests were normal or negative. OTH OTH Glipizide, Metformin, Metoprolol, Nitro-Bid, Omeprazole, Quinine UNK hypertension, chronic obstructive airway disease, diabetes mellitus HQ2574727JUN2001 1
0173042 07/09/2001 OK 0.7 0 .7 F 06/06/2001 15-20 minutes, post vax, baby turned bright red. Mom called doctor and child was taken immediately, to ER where airway was obstructed and hives were developing. Epinephrine and Benadryl was given. Baby recovered and was allowed to go home. Y Y Y 06/05/2001 06/05/2001 0 PUB PUB NONE NONE NONE OK0126 1
0173044 07/09/2001 AK 7.75 8 M 12/07/2001 On 5/25/01, the pt received his 1st dose of Engerix-B and his 1st dose of Hep-A (Havrix); see 20010157852. Four days later, on 5/29/01, the pt developed "intense" abdominal pain. Five days later, on 6/3/01, the pt developed the characteristic rash of Henoch-Schonlein purpura. The urinalysis was initially normal. On 6/26/91, the pt was seen by the physician and microscopic hematuria was noted. The urinalysis showed moderate red blood cells, no protein, and no glucose. The serum creatine was normal. Henoch-Schonlein purpura is considered to be "Medically Serious". As of 6/27/01, the rest was ongoing. F/U UA results added. No drugs were used to treat the adverse events. The IM doses of Engerix-B and Hep-A were 0.5cc. The reporter stated that the acute abdominal pain was moderate-to-severe and was disabling/incapacitating. The reporter stated that the Henoch-Schonlein purpura skin lesions were moderate in severity and the persistent microscopic hematuria was mild in severity. He considered all the events to be possibly related to the vaccines administered. The most recent information was received on 9/24/01. The reporter indicated that the abdominal pain and skin lesions resolved on 6/15/01. The microscopic hematuria was ongoing. The most recent info was received on 11/27/2001. The vaccinee had completely recovered by 08/28/2001. Y Y Y 05/25/2001 05/29/2001 4 UA-nml on 6/13/01; creatine-6/26/01-nml; UBLD-microscopic hematuria; UGLUC-0; UPR12-0; On 7/10/01 and 7/31/01, UA were 1-2+ positive for occult blood with 2-4 RBC/high-powered field (hof) and "everything else" was neg. Pt's height: 54" and weight: 67lbs PUB PUB NONE NONE NONE 20010157851 1
0173047 07/09/2001 NJ 1.0 1 .0 M 06/29/2001 From mailed correspondence received on 6/29/01 from reporting nurse, stated that a 12 month old pt received an IPOL and a Varivax vaccination on 6/11/01 at 10:30AM. Reportedly on 6/12/01 at 13:30, the pt was in daycare and experienced a "faint episode", was pushing toy, looked wobbly, went limp, "breathless" color of lips turned purple and his head went back. There was no foaming at the mouth. The episode lasted for a few minutes; the pt then took a breath. There were no tonic-clonic movements. The pt now has right otitis media. He reportedly, recovered from this event. No further information was provided from follow-up correspondence returned on 10/25/01. Y Y 06/11/2001 06/12/2001 1 PVT PVT URI "for a few days" U2001008430 1
0173048 07/09/2001 GA 1.08 1 .0 M 06/11/2001 Taken to ER on 5/4/01 due to loose stools and fever and vomiting X 2 days. Taken to clinic on 5/5/01 and was admitted. Had blood in stool. 12 month old male child with a 3 days history of fever (max to 105.7F), vomiting and watery green, bloody, mucoid stools. He was put on amoxicillin 125mg po TID. Decreased appetite and inactive restless and fussy all night. No cough or runny nose. Discharged on 5/9/01, afebrile, good appetite and less frequent stools. Sent home on Augmentin and Bactrim, restricted activity and diet for age and follow-up with PMD. Dx: acute gastroenteritis (presumed bacterial enteritis), anorexia, dehydration and hyperpyrexia. On 5/31/01, seen due to injury to mouth with upper lip edema. Popsicles prn lip swelling, cold compresses to upper lip several times a day and Tylenol for pain. Also, grandmother said he felt warm to touch yesterday and he has been less active. Also, today mother said he does not want to take/drink fluids and seems as if his mouth hurts. He did not take his breakfast today. DX: tonsillitis and anorexia. Give fluids as tolerated. On 5/16/01, had rash on bottom x 3 days, treated with Nystatin ointment Y Y 2 Y 05/04/2001 05/04/2001 0 Scotch tape test to r/o pinworms; Stool culture-neg; Occult blood feces-pos PUB PUB NONE Loose stool X 2 and temperature in the 100'sF GA01054 1
0173055 07/09/2001 OR 1.2 1 .2 F 07/03/2001 Vaccines given on 6/22/01. Parent called on 6/29/01, stating that pt had a febrile seizure, the night after vaccines given. Called 911 and O2 was given. Sat 95%. Y Y 06/22/2001 06/22/2001 0 Exam on 7/2/01; Neuro-WNL PVT OTH MVT/FL .25mg NONE Eczema 1
0173056 07/09/2001 OK 0.2 0 .2 F 06/08/2001 "Seizure-like episode", legs twitching, eyes rolled back of head. Pt was wide awake, whole episode lasted 30 seconds. Y Y 05/18/2001 05/20/2001 2 NONE PVT PUB NONE NONE NONE OK0127 1
0173057 07/09/2001 AR 0.4 0 .4 M 07/02/2001 pt had seizure, shaking of arms and legs rhythmic, lasted 5 seconds. Temperature was 100.6 F at ER Y Y 06/29/2001 06/29/2001 0 CBC at hospital normal by report PVT PVT NONE NONE NONE 1
0173058 07/09/2001 OK 1.7 1 .7 F 06/21/2001 Child awoke with swollen, red left upper arm. The area was warm, redness extended to about 2 1/2 inches above elbow. Afebrile, Mother tried Motrin about every 6 hours yesterday and today. Redness area approximately 2 inches x 9 1/2 inches. Y 06/20/2001 06/21/2001 1 PUB OTH Motrin NONE NONE OK0128 1
0173059 07/09/2001 GA 42.0 43 F 06/13/2001 Pt returned to clinic approximately 10 min after MMR injection, complaining of feeling dizzy, flushed, chest tightness, SOB, weakness. B/P was 122/86 at 2:30, but 2:40 states she was feeling better. Y Y 06/12/2001 06/12/2001 0 Blood Pressure reading PUB PUB allergy injection done on 06/11/2001, Zyrtec, Celebrex, Synthroid, Prilosec, Levbid, inhaler None See attached list of allergies edema, inflamation~Pneumo (no brand name)~1~38.00~In Patient GA01058 1
0173060 07/09/2001 GA 38.0 38 F 06/07/2001 Two days after vaccination the patient's left arm at the site of the injection became sore and after a month is still sore. There was no redness or lumps. The patient was advised to try warm compresses. U 05/08/2001 05/10/2001 2 NONE PUB PUB NONE NONE Penicillin GA01057 1
0173061 07/09/2001 GA 21.0 21 F 06/14/2001 5/11/01 pt rec'd immunizations 3:30pm 4/27/01 in the evening 4/28/01, had trouble breathing and had to use inhaler continued to use inhaler 4-6 x day through out the next several days (normally she uses it 1 x day) On Wed am 5/2/01 her L arm was sore where she received the yellow fever vaccine. She put a cool cloth on it and took advil. On 5/4/01 pt began itching all over her body - rash was over body but raised on her arms and she went to the ER. They gave her Prednisone and sent her home on it. She called her allergist Mon. because she couldn't sleep on the Prednisone - cut Prednisone down to 1x day until Wed. 5/9/01. She continues to use inhaler 3x day now. States she had food poisoning yesterday no N/V today. R arm is red at injection site - no more rash. Pt states L arm throbbed from shoulder to wrist for about 2 wks after receiving YF injection. Skin over injection site peeled - no bigger than a dime - no other problems. Y Y 04/27/2001 04/28/2001 1 PUB UNK NO Asthma, allergic to wheat, Augmentin, PCN, ?, Cefzil, headaches GA01056 1
0173062 07/09/2001 GA 47.0 47 F 06/22/2001 Pt states she stepped on a sewing needle & injured her R foot on 6/8/01 and she called the 24 hr nsg at Hosp and she was told to get a Td shot within 72 hrs, to use betadine to clean the wound and apply Neosporin oint which she did. The nsg called her back on Sun 6/11/01 to check on he & remind her to get a Td vaccine. States she came to HD on Mon 6/11/01 for the Td. Pt states her R arm awakened her at 2pm Tues 6/12/01 & it was very painful, swollen, hard, and had deep pain. She took a general brand of ibuprofen 2 tablets and applied warm compresses to her R arm. Her oral temp was taken and it was 101.0F. She repeated the ibuprofen tablets every 4-6 hrs, and laid down. Her fever broke but her R arm was still painful. She did not to to work due to the fever. She went to work on 6/13/01 and her R arm was still painful and later on Wed her R underarm and her R breast were very painful, she then called her PP's office and was advised by the staff to have a mammogram done. She applied hot soaks to both breast at home on Wed she worked part of the day on Wed and Thur. On 6/14/01 pt called the Hlth dept and spoke to a female and was told to switch out with the warm compresses and apply cold compresses. The mammogram and ultrasound results showed inflammation of the lymph nodes and R breast and he films were given to her to take to her Physician. On 6/20/01 she was seen and examined and determined that her lymph nodes were infected and believed it was a result of the tetanus shot, and advised her to see her PP. She was diagnosed with Lymphadenopathy R axilla and prescribed Keflex for infection. Dr advised her to still follow up with adverse reaction to the tetanus shot. Y N 06/11/2001 06/12/2001 1 Mammogram/Ultrasound - inflammation of lymph nodes also Lymphadenopathy R axilla. PUB PUB Injury R foot Fibrocystic Breast disease diagnosed 15 yrs ago GA01061 1
0173063 07/09/2001 GA 1.5 1 .5 M 06/25/2001 Pt grandmother took him to the Dr 2 days after receiving DTaP for regular check up. Asked MD to look at his leg because it was swollen from the shot. He told her DTaP caused infection. Y 06/11/2001 06/12/2001 1 Blood test for infection? PUB PUB NONE NONE NONE GA01059 1
0173064 07/09/2001 GA 12.0 12 F 06/21/2001 After pt received her vaccine she fainted and landed on floor. c/o pain to R hand /wrist. Slight swelling of R hand and fingers. Y Y 06/21/2001 06/21/2001 0 X-ray - Fx R hand index, middle finger PUB PUB tylenol po NONE GA01060 1
0173065 07/09/2001 GA 2.0 2 .1 M 06/14/2001 L leg swollen, warm to touch, fever, from knee upward. ER 6/2/01 reaction Tx, 6/3/01 Cefzil, PMD 6/4/01 kept on Cefzil. Y Y 06/01/2001 06/01/2001 0 PUB PUB NONE NONE GA01055 1
0173066 07/09/2001 GA 31.0 31 F 06/11/2001 Approximately 25mg swollen area at site of injection = approx 3/4 of upper arm around site red. Y 06/06/2001 06/08/2001 2 saw Dr on 6/11/01 to probably get steroid was given antihistamine on phone PUB PUB GA01052 1
0173067 07/09/2001 GA 2.0 2 .8 M 06/07/2001 On 05/26/2001 the patient's left arm became swollen 3 times its normal size. The patient had a "whelpy" rash all over his body and was holding his throat. The patient was seen at the ER and was treated with Benadryl and Atarax. Y Y 05/24/2001 05/26/2001 2 NONE PUB PUB NONE NONE Epilepsy - takes Phenobarb only with a seizure GA01051 1
0173068 07/09/2001 VA 4.0 4 M 06/27/2001 Patient developed 20-25 lesions on his face, trunk and hands. Patient had 2 lesions in his mouth. Y 05/26/1998 04/03/2001 1043 NONE PVT PVT NONE NONE NONE 1
0173069 07/09/2001 OK 1.25 1 .3 M 06/05/2001 The day after the patient received the DTAP and Varicella vaccinations, the patient developed a red, raised area approximately 5 cm around/across and several other red whelped areas. Y 05/29/2001 05/30/2001 1 PVT PUB Zyrtec, Augmentin Otitis media, allergies Seasonal allergies OK0125 1
0173070 07/09/2001 OK 4.0 4 F 06/21/2001 The patient was given her 2nd MMR and within 10-15 minutes her right arm above the injection site was red, swollen and warm to the touch. Ice was applied to the site. There was no previous reaction reported. Y 06/20/2001 06/20/2001 0 NONE PUB PUB NONE OK0129 1
0173071 07/09/2001 CA 1.75 1 .8 F 07/03/2001 The patient experienced a fever of 100.2F two days post-immunization. U 06/14/2001 06/16/2001 2 NONE PUB OTH NONE Fever 99.1 NONE 1
0173072 07/09/2001 NV 1.0 1 .6 M 06/06/2001 Four hrs after receiving immunizations, pt developed crying, irritability, and slight swelling of the right leg. Two days post immunizations, 4/11/01, pt's right thigh was noted to be swollen, reddened and inflamed, and he had a fever. He was immediately hospitalized for 24 hours and treated with IV antibiotics. He was diagnosed with cellulitis of right leg. Y Y 1 Y 04/09/2001 04/11/2001 2 UNK PUB PUB NONE NONE NONE NV0107 1
0173074 07/10/2001 CA 1.2 0 .2 M After receiving DTAP, pt had an unusual cry for 2 days. It was elected not to give him any further AP vaccine. He was subsequently diagnosed with profound hearing loss. The annual follow up states the pt has profound hearing loss. Y N 06/19/2000 06/20/2000 1 PVT PVT NONE NONE NONE 1
0173075 07/10/2001 WA 1.0 1 .0 M 07/02/2001 Febrile seizure Y 2 Y 05/29/2001 06/09/2001 11 Negative CSF Studies PVT PUB Tri-Vi-Flor Drops NONE NONE WA031955 1
0173076 07/10/2001 IL 1.75 1 .8 M 06/26/2001 Pt developed elevated temperature of 104, fixed eyes, stiffness and unresponsiveness. He was taken to ER and diagnosed with seizure. Y Y Y 1 Y 04/11/2001 04/12/2001 1 EEG, CT, MRI PUB PUB Tylenol NONE NONE IL01025 1
0173077 07/10/2001 OH 1.4 1 .5 M 06/29/2001 Pt had immunizations at 11:30 AM on 06/28/01, had temp of 100.8 at 4 PM acting fine. At 8 PM had a seizure lasting more than 2 min, Went to ER and temp was 103.3-did lab,bloodwork, cbc, electrolytes were normal. Y Y 2 Y 06/28/2001 06/28/2001 0 CBC, Electrolyes, U/A PUB PUB NONE NONE Family has a history seizure disorder OH0041 1
0173083 07/10/2001 TX 1.08 1 .1 F 06/27/2001 The patient developed erythema multiforme 7 days after receiving vaccinations. Y U 06/19/2001 PVT UNK NONE NONE NONE 1
0173084 07/10/2001 TX 0.5 0 .5 M 07/02/2001 Fifteen minutes after the vaccine was administered the patient broke out in a rash on his stomach, back, diaper area and face. The patient's hands, feet and face became pale and clammy. The patient was treated with Benadryl. Y Y 07/02/2001 07/02/2001 0 NONE PUB PUB NONE NONE NONE 1
0173085 07/10/2001 AZ 0.4 0 .4 M 07/09/2001 On 07/06/2001 the patient experienced a fever of 104F and wheezing. On 07/07/2001 the patient developed a rash and fussiness. Y 07/02/2001 07/02/2001 0 NONE PVT PVT NONE NONE NONE 1
0173086 07/10/2001 WI 1.25 1 .3 F 07/05/2001 The patient developed a fever of 105.1F in the ER on 07/04/2001. Y U 07/03/2001 07/04/2001 1 UA-wnl PVT PUB NONE NONE Allergy to aloe 1
0173087 07/10/2001 WA 1.4 1 .5 M 06/28/2001 24 hours after immunization the patient developed redness and swelling at the injection site and a fever of 101F. Purulent drainage from the injection site was observed by the parents, but was not seen by the MD. The patient was treated with antibiotics for possible cellulitis. Y Y 06/26/2001 06/27/2001 1 PVT PUB NONE Hydronephrosis 1
0173088 07/10/2001 AZ 1.6 1 .3 F 06/20/2001 On the day of the vaccination the patient experienced blotchy skin on her face and neck. The following day the patient's right eyelid was swollen. The second day after vaccination, the patient's left eyelid was swollen. The patient was seen in urgent care and no treatment was needed. Y 03/01/2001 03/02/2001 1 NONE PVT PVT NONE NONE NONE 1
0173089 07/10/2001 PA 1.5 1 .4 F 07/03/2001 The patient experienced 1-3 days progressive eruption without systemic symptoms except a limp left ankle. The patient had generalized distributed blanching with 3-15mm rose colored papules and plaques and swollen neck glands. Y U 06/13/2001 07/01/2001 18 NONE PVT UNK Cherry Benadryl NONE 1
0173090 07/10/2001 UT 0.3 0 .3 M 06/29/2001 Patient developed redness, tenderness and swelling on the right thigh. Patient experienced crying. Doctor diagnosis is a local reaction to DTAP. Y Y 06/28/2001 06/28/2001 0 PVT PVT NONE NONE 1
0173091 07/10/2001 UT 0.2 0 .2 M 07/03/2001 The patient's mother called on 06/27/2001 stating the patient had been screaming non-stop for 1 hour. The patient's thigh was red, swollen and tender. The patient was treated with Tylenol. Y Y 06/27/2001 06/27/2001 0 PVT PVT NONE NONE NONE 1
0173092 07/10/2001 PA 55.0 55 F 06/27/2001 Patient became paralyzed and could not move legs for several hours. She had continued pain. This was her third Lymerix vaccine. The 60 day follow-up states that the pt developed severe arthritis in knees since the vaccine. After being treated by several doctors, they feel the damage has already been done. Also, she developed hypertension. Y N 03/15/1999 06/04/1999 81 Labs performed on numerous dates-abnormal PVT PVT NONE joint pain, knees swollen, irritable~Lyme (LYMErix)~1~0.00~In Patient 1
0173093 07/10/2001 UT 5.0 4 M 07/03/2001 The patient developed a red, swollen, tender spot on the left thigh. Y Y 06/27/2001 06/27/2001 0 PVT PVT NONE NONE NONE 1
0173094 07/10/2001 IN 10.0 10 M 07/03/2001 The patient experienced agitated behavior, personality change, insomnia and hallucinations on 2 occasions following HepB vaccines. Y U 06/19/2001 07/01/2001 12 NONE PVT PVT NONE NONE 1
0173095 07/10/2001 PA 36.0 36 F 07/02/2001 The patient experienced nausea, dizziness, itching, heaviness in chest, hives at the injection site, some rash on her arms and a headache. The patient was treated with Benadryl, Prednisone and Vistaril. Y Y 06/29/2001 06/29/2001 0 OTH PUB NONE 1
0173096 07/10/2001 CA 37.0 37 M 06/28/2001 On 01/03/2001 the patient complained of myalgia and joint pain for 2 weeks. The patient was treated with ibuprofen and told to return in 2 weeks if symptoms persisted. The patient did not return until 06/21/2001 with symptoms ongoing. U 12/18/2000 12/20/2000 2 OTH PUB Ibuprofen Chronic low back pain, fatigue, Hepatitis C+ Long history of multiple myalgias since 1999. 1
0173097 07/10/2001 CA 41.0 41 F 07/03/2001 A few hours after 12 diaphoresis X 15 took motrin. This a.m. awoke with fatique, lethergy, muscle aches - moderate scale Y 07/02/2001 07/02/2001 0 NONE PUB PVT 1
0173098 07/10/2001 LA 18.0 18 M 07/05/2001 Mother called clinic on 7/5/01, stating that the child was taken to doctor with complaint of "a swollen gland under the arm that shots were given in and complained of pain in the area". Child was placed on antibiotics. Y U 06/29/2001 07/03/2001 4 NONE PUB UNK NONE LA010701 1
0173099 07/10/2001 IL 1.0 1 .0 F 07/02/2001 Pt developed rash all over 7/1/01 - but worse on face, irritable, appetite decreased, fever of 101F - axcillary started 6/29/2001, Rash fading 07/03/01. Y 06/12/2001 06/29/2001 17 PUB UNK NONE NONE NONE 1
0173100 07/10/2001 PA 26.0 26 F 07/02/2001 Arm sore, numb, swollen fingers numb and swollen ( Rx - pain medication) Y Y 06/29/2001 06/29/2001 0 OTH PUB NONE Allergies to Bactrim, Penicillin, tomatoes, bee stings, dust, asthma 1
0173101 07/10/2001 MA 4.0 4 M 06/20/2001 Within 2 minutes pt began to dry heave, turned very pale and appeared to faint briefly. Responsiveness slowly returned. By 30 min after injection pt was playing and speaking normally with normal visual signs. Telephone follow up 7 hrs later pt ok. Y Y 06/20/2001 06/20/2001 0 BP 70/42, HR 60, O2 sat 77 initially. HR increased to 70 - 80's within 20 min. PVT PUB NONE NONE NONE 1
0173102 07/10/2001 OH 43.0 42 F 07/15/2001 Pt rec'd Td 6/22/01 after stepping on rusty nail 6/19/01. Called dept 6/25/01 8:30am complaining of fever 104.0F and body aching. Saw her Dr 6/27/01 and was told reaction to Td. Y Y 06/22/2001 06/25/2001 3 NONE KNOWN PUB PUB Antibiotic for puncture wound NONE KNOWN Pt stated she is diabetic 1
0173103 07/10/2001 HI 3.0 M Pt has chickenpox, fever of 99F and a few red spots were first noticed on the pt 6/1/01. A fever on 102F and a rash on face, torso, arms and legs developed that evening. Pt was seen by Dr on 6/2/01 when 75-100 lesions of all stages from macules to vesicles to scabs scattered pt's trunk and extremities. The eventual 300-500 lesion also involved his head, lips, ears, hands, fingertips, palm,soles, of his feet and genital area. Pt was prescribed Zovirax 200mg,2 tsp QID for 4 days. All lesions were dried by 6/8/01. There was no known exposure although another student at his school reported chickenpox at the same time. The pt rec'd varicella vaccine 1/16/97. He was reported to have no measurable antibody on 11/17/97 and rec'd Varivax on 12/23/97. Y Y 06/01/2001 PVT UNK 1
0173104 07/10/2001 NC 55.0 55 F 06/26/2001 SOB, hoarseness approx 2-3 hrs post vaccine. Scalp sores, increased LFT, uncontrolled blood sugars, severe fatigue, diplopia, neck pain, numbness head and face. N 05/30/2001 05/30/2001 0 PVT OTH ASA, glucotrol, Claritan Hepatitis C virus Apparently had similar episode after hydroxyzine dosing 1 yr ago. No known allergies. 1
0173105 07/10/2001 OH 12.0 12 F 07/03/2001 On the AM following the administration, pt experienced sensation of heart racing accompanied by some dizziness and dyspnea lasting 1 hr, then to a lesser degree intermittently. Reassurance. Y 06/13/2001 06/14/2001 1 EKG PUB OTH NA NA 1
0173106 07/10/2001 SD 1.4 1 .4 M 06/20/2001 Pt developed urticaria over entire body 6 days post immunization of MMR, DTaP, HIB, IPV. Tx consisted of antihistamines. Y Y 06/14/2001 06/20/2001 6 WBC 4,300 48seg/47 lumph/3mons/2eas. plts 250,000, rapid strep Neg PVT UNK NONE Congenital critical aortic stenosis. 1
0173107 07/10/2001 WI 23.0 23 F 06/27/2001 Pt caught finger tip in a window 6/25/01 evening. Pt called the Clinic and was advised to get a TD at the Hlth Dept. Pt woke from sleep, 2am, 12 hrs after the shot, and felt pain in her spine and ears. She was sweating and chilling the rest of the night. Today pt's ears felt like they are popping and headaches. 6/28/01 symptoms were all gone. Y 06/26/2001 06/27/2001 1 PUB PUB NONE NONE 1
0173108 07/10/2001 SC 4.0 M 06/28/2001 2 days post immunization, acute swelling, redness and slight warmth to L upper arm to elbow. U 06/26/2001 06/28/2001 2 NONE PVT UNK NONE NONE NONE 1
0173109 07/10/2001 PA 29.0 29 F 07/02/2001 Rash on arms, abdomen, face, body itchy, hot, malaise, swelling of fingers and hands, difficult swallowing. Rx benadryl; course of Prednisone. Y Y 06/29/2001 06/29/2001 0 OTH PUB Inhaler NO Asthma/smoking 1
0173110 07/10/2001 MI 4.0 4 F 06/21/2001 Local & systemic reaction 5x5cm erythemic area on L upper leg. Also hives everywhere about 8-10 hrs post shots. Tx with benadryl & Zyrtec. Hies resolved 6/14/01. Y Y 06/12/2001 06/12/2001 0 PUB PUB 1
0173111 07/11/2001 WA 0.4 0 .4 U 07/03/2001 Information has been received from a physician concerning a 5 month old pt with wheezing prior to immunization who in approx. 8/99 was vaccinated with a dose of haemophilus b conjugate vaccine (+) Hep-B vaccine recombinant (yeast). This report was part of a post-marketing surveillance program. Concomitant therapy included MMRII and diphtheria toxoid/pertussis vaccine/teta. The physician reported that the pt's wheezing got progressively worse over the 4 days, post vax. On 4/27/99, the pt was treated in the ER. The pt responded to bronchodilators. On 8/28/99, the pt's condition worsened and needed to be hospitalized. It was reported that the pt recovered. The reporting physician felt that the wheezing was possibly related to study therapy. No further information is available. Y Y Y 08/01/1999 08/01/1999 0 OTH OTH Wheezing WAES01061932 1
0173122 07/11/2001 AK M 07/03/2001 Information has been received from a female consumer concerning her friend's son who was vaccinated "years ago" with a dose of MMRII. Subsequently, she reported that her friend's son developed autism. Additional information has been requested. Upon internal review, the autism was considered an "Other Medical Event". U OTH OTH UNK UNK WAES01062368 1
0173130 07/11/2001 FL 48.0 48 F 07/02/2001 Information has been received from an RN concerning a 48 year old white female RN who in approx. 1994-1995 was vaccinated with Hep-B vaccine recombinant (yeast) series. Subsequently, upon titer on 11/28/00, the pt did not show seroconversion and elected to repeat the series. On 1/9/01, she received Hep-B (lot 637850/1577K) and MMR vaccine (lot 635921/1181K). On 2/20/01, the pt received her 2nd Hep-B vaccine (lot 637847/1654K). On 4/24/01, the pt contacted the nurse to report that after the 2 vaccinations on 1/9/01, she had a fever and flu-like symptoms in the afternoon of 1/9/01, her left arm was sore and she had a lump in her arm that resolved in a few days. After the second dose of Hep-B, she experienced symptoms of a sore joint, at the deltoid muscle, with limited range of motion, difficulty raising her arm to brush her hair and pain that radiated down her elbow into her wrist. The pt was concerned that it was "permanent damage". The nurse reported that the pt was able to work and as of 5/11/01, was currently working. On 5/24/01, the nurse reported that the symptoms of the left shoulder pain and wrist pain and limited range of motion were slightly resolving. No further details were provided. Y N 02/20/2001 Serum Hep-B on 11/28/00-did not show seroconversion UNK UNK UNK WAES01050209 1
0173131 07/11/2001 WA 0.5 0 .6 U 07/02/2001 Information has been received from an investigator concerning a 6 month old pt who on 1/20/99 was vaccinated with haemophilus b conjugate vaccine (-) hepatitis b vaccine recombinant (yeast). This report was part of a post-marketing surveillance program. Concomitant therapy included inactivated poliovirus vaccine and diphtheria toxoid/pertussis/tetanus vaccine. On 1/24/99, the pt experienced a 30 second tonic-clonic seizure followed by a post-ictal state, "then was happy". The pt was seen in the ER and dx'd with a 1st afebrile seizure. No treatment was given, and the pt was sent home. The pt recovered. The pt will follow possibly related to study therapy. The 1st afebrile seizure was considered to be an "Other Medical Event". No further information is available. Y Y 01/20/1999 01/24/1999 4 PVT OTH UNK WAES01062217 1
0173133 07/11/2001 WA 0.16 0 .2 F 06/29/2001 Information has been received from an investigator concerning a 10 week old female who on 8/11/99 was vaccinated, IM, in the right anterior thigh, with a dose of haemophilus b conjugate vaccine (+) hepatitis b vaccine recombinant (yeast). Concomitant vaccination, the same day, included a dose of poliovirus vaccine inactivated (manufacturer unknown) (lot N0956) given SC, in the left anterior thigh and a dose of diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid (manufacturer unknown) (lot 7388AA) given IM, in the left anterior thigh. This report was part of a post-marketing surveillance program. On 8/22/99, the pt developed a fever and viral (presumed) gastroenteritis and was hospitalized. It was reported that the pt was treated with antibiotics and did well. The pt was hospitalized for 3 days and subsequently recovered. The investigator reported that the pt's adverse experiences were "possibly related" to therapy with the study vaccine. No further information is available. Y 3 Y Y 08/11/1999 08/22/1999 11 PVT OTH UNK WAES01061492 1
0173136 07/11/2001 WA 2.2 2 .1 U 07/02/2001 On 8/10/98, pt experienced a 30 minute generalized seizure followed by shorter seizures of 60 to 90 seconds. The pt was hospitalized and treated with IV diazepam (Valium), and then with carbamazepine (Tegretol). Subsequently, the pt recovered. Pt was discharged after 1 day in the hospital with a diagnosis of idiopathic seizure disorder. The reporting investigator felt that idiopathic seizure disorder was possibly related to study therapy. No further info is available. Y 1 Y 08/08/1998 08/10/1998 2 PVT OTH UNK WAES01062216 1
0173137 07/11/2001 WA 1.3 1 .3 U 07/02/2001 On 9/16/98, pt experienced a breath holding spell followed by a 30 to 60 minute convulsion. An ER or MD visit was required. Pt was given diazepam (Valium) but no outpt therapy. Subsequently, pt recovered. The reporting investigator felt that the breath holding spell and convulsion were possibly related to study vax. Upon internal review, these were considered to be other important medical events. No further info is available. Y Y 09/09/1998 09/16/1998 7 PVT OTH irregular breathing, seizure WAES01062223 1
0173138 07/11/2001 WA 0.4 0 .4 M 07/02/2001 On 2/10/00, pt experienced respiratory distress. The respiratory distress and increasing oxygen requirement increased over the next 5 days, and pt was hospitalized for 11 days. Subsequently the pt recovered. The reporting investigator felt that the symptoms were possibly related to study vaccine. No further info is available. Y 11 Y 02/09/2000 02/10/2000 1 Chest X-ray-right pneumonia UNK UNK Bronchopulmonary dysplasia Prematurity WAES01062215 1
0173157 07/11/2001 IL 0.5 0 .5 F Pt experienced a prolonged seizure and apneic spell. Pt had no problems with previous immunizations. Y Y 05/14/2001 05/14/2001 0 Metabolic, CSF, CT brain, blood culture-all wnl; WBC=20.6 PVT UNK NONE NONE 1
0173158 07/11/2001 MO 16.0 M 07/04/2001 Pt complained of dizziness and fever following vax. Pt then complained that his knees hurt, and he couldn't walk. Pt missed 3.5 days of school. Pt was taken to MD who diagnosed flu. Pt also complained of being sore all over. Y Y 02/16/2001 PVT OTH NONE NONE NONE 1
0173159 07/11/2001 ID 1.5 1 .4 M 07/06/2001 Pt experienced swelling of thigh left to 2 X normal about 12-24 hrs after Dtap, ipv,hib,prevnar. Minimal erythema or tenderness. No fever, mental status change, vomiting or chills, slight limp on right present prior to immunizations. Swelling lasted 3 days and resolved. Did not present to MD until 1 week following vaccination - dose 1 lederle dose 2,3 skb Y 06/29/2001 06/30/2001 1 NONE PVT PUB NONE NONE 1
0173160 07/11/2001 ID 0.5 0 .6 M 06/15/2001 103.2 degrees F temp following vaccination Y 06/11/2001 06/12/2001 1 PUB PUB NONE ID01031 1
0173161 07/11/2001 IN 4.0 3 F Pt received Dapt & IPV in left upper arm on 6/13 on 6/15 the left deltoid area with received Dapt had a large erythematous swollen area which was warm and tender to touch. area 5 X 5cm. pt started on keflex and compresses. Y Y 06/13/2001 06/15/2001 2 NONE PVT PVT NONE NONE 1
0173162 07/11/2001 VA 0.8 0 .8 F 06/29/2001 Patient developed erythema, 5 cm induration Y Y 06/25/2001 06/26/2001 1 MIL MIL 1
0173163 07/11/2001 NC 0.3 0 .2 M 07/03/2001 Mother stated today at 4 month well baby exam that 2 mos ago at the 2 month well baby exam after his shots she came out with hives. Y 05/01/2001 05/01/2001 0 NONE PVT PUB 1
0173164 07/11/2001 OR 1.0 1 .0 M 07/05/2001 Temp above 102 X 2 days. Started evening of 07/03/01- Tenderness at site of injection X 1 day IMM given in R thigh Y 07/03/2001 07/03/2001 0 PVT PUB NONE Diarrhea - 2 stools prior to immuniz NONE 1
0173165 07/11/2001 TN 0.2 0 .2 M 07/06/2001 Excessive crying, not sleeping well, decreased appetite. symptoms began on 07/03/2001 in early evening. Symptoms resolved 07/05/2001 late evening. Y Y 07/03/2001 07/03/2001 0 UNK UNK 1
0173166 07/11/2001 OH 1.08 1 .1 F 06/29/2001 (Chicken pox) varicella rash present on trunk. Less than 60 spots. No current exposure to varicella that mom is aware of rash began 06/28/2001 Y 06/19/2001 06/28/2001 9 NONE PVT PVT NONE NONE NONE 1
0173167 07/11/2001 WA 0.5 0 .5 F 07/02/2001 Drops / dips head to right shoulder, conscious less than 1 sec. Began occurring within 1/2 -1hr after shots given. 10-15 episodes in a row, then 2-5 sequence. At 4 days after shots, still 5-8 day. Y 06/28/2001 06/28/2001 0 NONE PVT PUB Not taken yet. Ametidine NONE NONE 1
0173168 07/11/2001 MI 1 .2 F 07/02/2001 Fever on set aprox 6 hrs after injections > 103.5 lasted 6/28.6/29. 6/30.7/1 had febrile seizure lasting < 7 min. looked ok after seizure Y Y 06/02/2001 06/28/2001 26 NONE PVT PVT 1
0173169 07/11/2001 UT 1.0 0 1 F 06/27/2001 ATaxia U 06/01/2001 06/01/2001 0 PUB OTH 1
0173170 07/11/2001 PA 1.0 1 .0 M 07/05/2001 Patient received injection on 07/03/2001. pt has a fever on 07/04/2001 of 100.9. He started with a rash on chest and back. Today 07/15/2001 rash in also on arms and face U 07/03/2001 07/04/2001 1 NONE PVT PVT NONE NONE NONE 1
0173171 07/11/2001 FL 1 .5 F 06/28/2001 Child developed fever and seizure CPR was performed 911 called seen following day in office where her pargina dx cl. Y Y 06/19/2001 06/19/2001 0 WBC 54751SIB23L PVT PVT NONE NONE 1
0173172 07/11/2001 ID 0.2 0 .2 F 07/03/2001 Temp 104 Red swollen injection site right thigh Y 03/20/2001 03/20/2001 0 PVT UNK NONE NONE NONE 1
0173173 07/11/2001 CA 0.2 0 .2 F 06/11/2001 Immunization given at 10:00am. Cried with shot , slept until 12 noon, feel well, given tylenol 1:45 coughed began crying with high pitched hoalse cry. Irritable no other findings Y 06/11/2001 06/11/2001 0 PVT OTH NONE Umbilical hernia 1
0173174 07/11/2001 OH 0.5 0 .6 M 06/19/2001 Patient's mother reports non-stop crying for approximately 3-4 hours the morning after receiving immunizations. Y 01/23/2001 01/24/2001 1 NONE PUB PUB Infant Tylenol NONE Bronchitis in 12/2000 ~DTP (Tri-Immunol)~2~1.00~In Sibling 1
0173175 07/11/2001 OR 1.0 1 .0 M 06/01/2001 Within 2 minutes of receiving vax patient experienced a bright red, swollen area that was hard and tender. There was a small amount of whitish color at the center. The patient was treated with Benadryl. Y 06/01/2001 06/01/2001 0 NONE PUB PUB NONE NONE NONE 1
0173176 07/11/2001 NJ 0.3 0 .3 M 06/14/2001 The patient experienced prolonged crying and lethargy for one hour. Y 06/11/2001 06/11/2001 0 NONE PVT UNK 1
0173177 07/11/2001 MN 32.0 M 07/10/2001 On 7/14/00, pt received his first dose of Lymerix. Subsequently, pt experienced some arthralgias. The pt thought he might have Lyme disease. As of 7/6/01, the outcome of the event was unknown. The adverse event of arthralgias does not meet ICH serious criteria, but is being submitted as an expedited report by special FDA request per the 6/28/00 letter. U 07/14/2000 OTH OTH 20010163521 1
0173178 07/11/2001 MI 34.0 34 M 06/13/2001 On 05/30/2001 the patient woke sick to the stomach and tired. Four or five days later the patient developed soreness and swelling at the injection site with shooting pain. U 05/23/2001 05/30/2001 7 PUB PUB 1
0173179 07/11/2001 WA 4.0 4 M 07/05/2001 The patient experienced pain after receiving vax. Twelve hours later the patient developed erythema and edema. The patient was seen in the ER and treated for cellulitis. Y Y 07/03/2001 07/04/2001 1 PUB PUB NONE NONE 1
0173180 07/11/2001 NC 0.75 0 .3 F 07/02/2001 The patient experienced shaking and was pale 4-6 hours post-vaccination. Y 01/19/2001 01/19/2001 0 PVT PUB NONE NONE 1
0173181 07/11/2001 MA 1.25 1 .0 M 07/06/2001 The pt developed a rash, rash spreading with red spots with pustules in the middle. Mother is sure they are chicken pox. Y 06/13/2001 07/05/2001 22 NONE OTH PUB NONE URI NONE 1
0173182 07/11/2001 OH 75.0 74 M 07/02/2001 The patient experienced a fever of 99.9F and redness, slight edema and pain of the deltoid area. The patient had severe fatigue for 2 days. Y 06/29/2001 06/29/2001 0 PVT UNK 1
0173183 07/11/2001 TX 2.0 2 .0 M 06/20/2001 Eighteen hours after receiving the vaccination, the patient developed a fever and severe behavior changes. The patient became aggressive to the point of being belligerent. The patient experienced high pitched screaming, refused to eat or drink, developed hallucinations and was miserable. Y 06/18/2001 06/19/2001 1 PVT UNK NONE NONE NONE 1
0173184 07/11/2001 MI 5.0 5 M 06/18/2001 The patient developed a fever, swelling, redness and pain in the left deltoid/shoulder area. The patient was treated with cold compresses and Motrin. Y 06/13/2001 06/13/2001 0 NONE PUB PUB NONE NONE Asthma 1
0173185 07/11/2001 OH 9.4 9 M 06/14/2001 The patient developed chicken pox rash, a headache and a fever of 103F. The patient has 50 or more lesions. U 06/07/2001 06/12/2001 5 06/16/2001: Decreased platelets 107 x 10 9L (normal 150-450) PUB UNK Cystic fibrosis 1
0173186 07/11/2001 NC 4.0 4 F 06/15/2001 Child left health dept with mom and grandmother. Around 30 to 45 minutes later the mother returned. The child was wheezing, eyes swollen, and slight cough. the child had no symptoms before she received shots. Child fretful! RN instructed parent to go to ED immediately. Y Y 06/13/2001 06/13/2001 0 PUB PUB Inhaler for asthma NONE Asthma 1
0173187 07/11/2001 TX 16.0 16 M 05/30/2001 Patient was found lying in bed, lethargic and speechless 3 days after receiving immunizations. Y 02/28/2001 03/03/2001 3 PUB OTH UNK NONE NONE 1
0173188 07/11/2001 MA 1.6 1 .7 M 06/12/2001 Patient experienced erythema and pain at the injection site. Y Y 06/05/2001 06/06/2001 1 NONE PVT PUB NONE Contact Dermatitis 1
0173189 07/11/2001 NY 1.0 1 .8 M 05/31/2001 The patient experienced redness and swelling at the site of immunization. Y 05/29/2001 05/30/2001 1 PVT PUB NONE NONE 1
0173190 07/11/2001 ID 54.0 54 F 06/20/2001 On 06/20/2001 the patient complained of pain, hardness and swelling of her arm into the neck and chest area. The patient is unable to sleep. U 06/11/2001 06/19/2001 8 PUB PUB NONE Allergic to Penicillin ID01029 1
0173191 07/11/2001 ID 10.0 10 M 06/05/2001 The patient experienced pain in the arm, a fever, red blotches on dorsal aspect of the arm. The patient was treated with Tylenol with codeine, Demerol, and Benadryl. Y Y 05/08/2001 05/08/2001 0 PVT PUB Cyclosporin Nephrotic syndrome ID01030 1
0173192 07/11/2001 ID 1.0 1 .0 F 06/07/2001 The patient experienced swelling, a red knot, bruising and pain in the left thigh. The left thigh feels warm to the touch. U 06/04/2001 06/05/2001 1 PVT OTH NONE Ear infection ID01032 1
0173193 07/11/2001 ID 19.0 19 M 06/08/2001 Approximately 1 week post-vax the patient complained of tiredness and a headache. The patient's mother states he felt feverish, but did not check his temperature. The patient's mother also states that his skin has a yellowish tinge. The patient was seen by 2 different doctors, one of which felt the symptoms were vaccine related. The parents chose to not have patient complete the Hepatitis A or B series. Y 05/21/2001 05/28/2001 7 WBC-elevated PUB PUB NONE NONE ID01033 1
0173194 07/11/2001 ID 4.0 4 F 06/20/2001 On 06/09/2001 the patient developed a rash on her legs, arms and face. Then over the next few days she had blisters the size of nickels all over her face, legs and arms. The patient was treated with Acyclovir, topical steroid, Claritin and Benadryl. On 06/20/2001 the patient was recovering, but still had some rash. Y N 06/01/2001 06/09/2001 8 NONE PUB PUB NONE NONE ID01028 1
0173195 07/11/2001 ID 14.0 14 F 06/08/2001 Almost immediately after injection client developed a rash about 2 1/2 - 3 inches in circumference around area where vaccine injected. Area became itchy. About 10 minutes later 2 hives appeared on left side of face Y 06/08/2001 06/08/2001 0 PUB OTH NONE NONE ? allergy to corn syrup ID01027 1
0173196 07/11/2001 OH 5.0 0 .2 F 07/01/2001 On 6/5/96, she received a Hep-B vaccine, after which I was informed. There was no suspected reaction. On 7/5/96, she received another Hep-B vaccine, no suspected reaction. My husband and I put our trust in her doctor. We discussed with the doctor, the benefits and risks of vaccines and he was firm in his beliefs that all children should be fully vaccinated. We inquired why it was necessary for us to sign a release prior to vaccinations. We never did get a straight answer. We discussed postponing the vaccine schedule because of our concerns of administering so many at one time. Our concerns stemmed from a friend's child contracting polio from the live oral vaccine. This prompted my husband and I to do some research. The visit to the doctor's office on 8/5/96, is a day I will never forget. Following a debate with her doctor, I gave in. Upon administration of the Tetramune, my child began violently screaming in a high pitch that I had never heard before. I looked at the doctor, he left the room. I tried comforting my baby to no avail. She continued to scream as we went to the car. She was becoming exhausted but continued screaming, alternating with limpness. When we arrived home, I noticed she was extremely hot to the touch. She continued this new screaming type crying for several days. She was very agitated. This was not the same child I took into her doctor's office that day. We returned to his office a month or so later. He dismissed my concerns as nonsense. He told me that if I didn't agree with his philosophies, that I should find a doctor who did. We did find another doctor that believes in nutrition and prevention. Our child has not received any more vaccines. She was breast fed for 37 months. Aside from her agitated temperament, she is well. I may never know exactly what happened that day, but I do know something went wrong. I pray that someday God can give me an answer. I will never know how my normal, natural baby was supposed to be. As a parent, it is my responsibility to protect and love my children, do all that I can. Something neurologically occurred that day; something unwanted, unnecessary. I would do anything to take that day back. My husband and I will live with the sadness and guilt we feel for all the days of our lives. We wanted you to know what happened, so that hopefully, it can spare others from harm. N 08/05/1996 08/05/1996 0 PVT OTH NONE NONE NONE 1
0173197 07/11/2001 CO 4.0 4 M 07/05/2001 Pt given DTAP on 7/3/01 and on 7/4/01, pt had significant swelling and redness of arm with water-filled lesions. Y U 07/03/2001 07/05/2001 2 PUB PUB NONE NONE 1
0173198 07/11/2001 IL 51.0 51 F 07/02/2001 Vertigo, onset on 6/16/01. Treated with Meclizine. Y U 06/05/2001 06/16/2001 11 NONE PUB PVT NONE NONE NONE 1
0173199 07/11/2001 TX 1.0 0 1 M 07/02/2001 Had an insect bite to right cheek. On 6/30/01, he broke out on legs on 7/1/01 with multiple patches of urticaria on chest and legs. Treatment: Zyrtec 1/2 tsp, Aveeno, Caladryl. U 06/20/2001 06/30/2001 10 PVT PVT Synagis, Ext Poly-Vi-Sol NONE 34 week preemie VP maintenance secondary to IVH, cong hypothyroid 1
0173200 07/11/2001 AK 1.3 1 .3 M 07/04/2001 10 hours, post vax, pt's left leg swelled up from his hip to below the knee and became red and very hard. He cried inconsolably for 2 hours and would not walk on it or let anyone touch his leg for an hour, his left foot was dusky from lack of circulation due to the swelling. We took him to the ER, where his regular doctor was on call (he knows about his previous reaction to the DTAP). He was given Tylenol with codeine and ibuprofen and observed until circulation in his lower leg was fully re-established. He was sent home. The swelling took a week to go down. Y Y 06/06/2001 06/06/2001 0 NONE PUB PUB NONE NONE NONE Unspecified reaction~DTaP (no brand name)~~0.25~In Patient 1
0173201 07/11/2001 NY 2.0 2 .7 M Mom called to just let us know that the day after patient's shots and maybe for a few days after his arms hurt to move. She can't remember today 6/25/01 if she used tylenol. no redness noted on arms no swelling noted either. state nothing bothering patient now. U 06/05/2001 06/06/2001 1 NONE PVT UNK NONE NONE 1
0173202 07/11/2001 NY 5.0 5 M 07/03/2001 Mom called to just let us know that patient's arm is still sore. Mom states patient has to manipulate arm to actually find area where shot was given. Hasn't really complained about it before today 6/25/01. No redness no fever noted, no swelling either. U 06/05/2001 06/24/2001 19 NONE PUB PUB NONE NONE NONE 1
0173203 07/11/2001 ID 0.08 0 .0 F 07/06/2001 Hep B given per orders. Recdily hives appeared between upper thigh and knee lasting 10 min then fading. no further reaction Y 07/06/2001 07/06/2001 0 PVT PUB Ampicillin, Lasix X1, cleforan r/o sepsis asymptomatic 1
0173204 07/11/2001 41.0 41 F 07/02/2001 Post injection raised spot on L upper arm measuring aprox. 10cm. Hot to touch, painful. no range of motion difficulties, 3 days post. small raised area approx 5 cm. swelling going away Y 06/29/2001 06/30/2001 1 None MIL MIL BC Pills Rt sore throat Septra Arm Sorenes~Hep B (no brand name)~2~38.00~In Patient 1
0173205 07/11/2001 MT 39.0 39 F 07/03/2001 C/o headache on day 2 post VZV. Rash started on 7/1/01 , C/0 of itching - severe, unable to sleep. Varicella like lesions from worst down covering her legs and feet. A few on her arm . None in mouth, though she c/o sore throat MD gave zyrtec and advised aveeno bath Y U 06/25/2001 07/01/2001 6 PUB UNK None 1
0173206 07/11/2001 OH 41.0 41 M 07/02/2001 7 days after injection, bulls eye rash and whelps appeared on trunk and spread to legs. Ct went to ER but left without being examined. CT c/o itching and redness with malaise. Ct took zantac , Zyrtec and benedryl X 4 Days. then it resolved completely. Y 06/15/2001 06/15/2001 0 NONE PUB PVT NONE NONE NONE 1
0173208 07/11/2001 AZ 9.0 9 M 07/03/2001 Purctic, indurated, erythamatous. Fine papular rash, that started over L arm (DTAP site) spread across back and down to L leg 06/29/2001 07/02/2001 3 PVT PVT NONE Dermatitis due to allergy NONE 1
0173209 07/11/2001 IL 1.0 1 .0 M 07/03/2001 Erythema multiforme rash began 07/01/01 Fever 102.5 on 07/04/01 Y Y 06/26/2001 07/01/2001 5 PVT PVT NONE 1
0173210 07/11/2001 NC 5.0 5 M 07/03/2001 Local reaction - Rt thigh redness upp 6 cm in diameter, area blanches, sm. purplish lump mid area or redness. no fever. red area appeared thur day of shot, redness cont. at outer edge of pint now pinkened area. 06/28/2001 06/28/2001 0 PVT PUB NONE 1
0173211 07/11/2001 TX 32.0 32 M Hardness to the touch w/ redness and warmth to the touch Y 06/22/2001 06/23/2001 1 PVT PVT Flonase 1
0173212 07/11/2001 CO 1.7 1 .6 F 07/05/2001 Pt has a red, hot rash 12 cm x 16cm. It was very painful when touched. Pt also cranky. Y Y 07/03/2001 07/03/2001 0 NONE PUB OTH NONE NONE NONE 1
0173213 07/12/2001 VA 40.0 40 M 07/02/2001 Pt developed tension-migraine headache since 3/99, but none within 30 days of vaccine. Pt developed moderate local reactions, self-limiting, after Anthrax vaccines, 1,2,3, and 4. Diagnosed with allergic rhinitis. Y 6 Y 01/05/1999 03/01/1999 55 June 2001-CT sinuses & brain, MRI brain, lumbar puncture, Lyme, Malaria Thin/Thick, CBC, LFTs, chemistry-all wnl OTH MIL Multivitamins NONE Chronic tinnitus local reaction~Anthrax (Biothrax)~1~40.00~Patient 1
0173214 07/12/2001 MO 50.0 50 F 07/09/2001 From telephone contact with pt it was stated that a 50 yo female pt rec'd a TD adult vaccine on 3/23/01. Reportedly 23 hrs post vaccine the pt experienced a grand mal seizure. 6 days later the pt experienced another and was hospitalized for four days. Further information is requested. Y 4 U 03/23/2001 03/24/2001 1 UNK UNK U2001008470 1
0173230 07/12/2001 VA 1.25 1 .3 F 07/09/2001 Began with fever to 103 degrees 7 days after vaccines X 3 days then broke out in morbill form rash 3 days later Y 06/29/2001 07/06/2001 7 NONE PVT PVT NONE NONE 1
0173231 07/12/2001 NY 1.25 1 .3 M 07/06/2001 Child given Varivax on 13 June 01 Developed variecella lesions 10-14-01 later Y 06/13/2001 NONE MIL MIL NONE NONE Amoxicillin 1
0173232 07/12/2001 MS 0.75 0 .7 M 07/06/2001 7/3 had fever 101.8 otherwise well 7/4 at 3 am seen in ER after shaking episode with egar walled back. T 103.8 Dx; possible febrile seizure. 7/5 seen in office, reported temp at home 102.8 but 99 ax in office after motrin tx. dx: exudative tonsillitis Y Y 06/29/2001 07/03/2001 4 WBC 7/4 12.3 Bas. met profile 7/4 bur 4. ca o.s otherwise al. PVT PUB Lac Hydrin Eucerin eczema eczema 1
0173233 07/12/2001 IN 1.25 1 .3 F 07/10/2001 Received vaccine DTap and Hibon left thigh on 7/9/01 on many of 7/10 developed signifant redness swelling > 10 cm and upper l thigh Y U 07/09/2001 07/10/2001 1 PVT PVT NONE NONE 1
0173234 07/12/2001 MN 0.19 0 .2 M 07/06/2001 Cried after immunization - 4 hrs later: listless for about 3 day, crying more freq. pet pertussis rxn - hypo responsiveness. Y 04/26/2001 04/26/2001 0 PVT UNK None None None 1
0173235 07/12/2001 CA 5.0 5 M 06/20/2001 Patient came in with large red area on right arm. Area painful and red and swollen. no drianage. Pt also had small papula vedicular lesions on truck and arms. Given RX for keflex and benadyl. Y Y 06/18/2001 06/20/2001 2 OTH OTH none none none 1
0173236 07/12/2001 NY 1.08 0 .1 F 5/27/00 rash outbreak, 6/27/00 rash Y 06/17/2000 06/27/2000 10 N/A PVT PVT N/A NKA Rash outbreak~Hep B (Recombivax HB)~0~1.00~In Patient 1
0173237 07/12/2001 MN 21.0 21 F 04/30/2001 Swelling - underside both upper arms at site of both injections. L 31mm diam. VS 97.8 - 75-12 U 04/27/2001 04/28/2001 1 MIL MIL Diluent NONE NKDA 1
0173238 07/12/2001 TX 1 .8 M 07/02/2001 Fever, rash, lasted 12-24 hrs according to mother, induration & erythema at site of injection. Y 06/21/2001 None - mother could not afford lab work. PVT PUB NONE NONE 1
0173239 07/12/2001 MA 4.0 1 .0 F Rash - face, arm and legs, itchy,a diffused red papular rash over face into scalp, upper arms, upper legs. Y Y 04/10/1998 NONE PVT PUB 1
0173240 07/12/2001 TX 1.25 F 06/19/2001 Rash (facial), fever 102F, irritability lasted 24 hrs Y 06/11/2001 06/11/2001 0 NONE PVT PVT NONE 1
0173241 07/12/2001 GA 3.0 3 M 07/11/2001 Rash Y 06/28/2001 07/08/2001 10 NONE PVT PUB NONE Healthy NONE 1
0173242 07/12/2001 NH 47.0 47 F 07/11/2001 Vaccine given 6/25/01, on 7/7, developed fine rash see over body with low grade temp Y Y 06/25/2001 07/07/2001 12 PVT UNK NONE NONE 1
0173243 07/12/2001 CA 5.0 5 F 05/31/2001 Fever 102F consistent, able to decrease temp some with tylenol/ Redding around L thigh injection (IPV) visualized red spots, Varicelliform rash per MD. U 05/29/2001 05/30/2001 1 PVT OTH Amoxicillin 250 ml, 1tsp tid x 10 days L otitis media with effusion 1
0173244 07/12/2001 CA 45.0 45 F 06/14/2001 2 hrs after rec'd vaccine started neck pain Rt side radiated from injection site up neck - very painful to move head in any direction. 4/30/01 came to clinic with pain in neck. Injection site no redness, no swelling. Dr checked pt said it was probably muscular, to apply heat, rest and take motrin. Ret'd on5/4/01 but left without being seen. U 04/27/2001 04/27/2001 0 PUB OTH NONE N/A 1
0173245 07/12/2001 CA 22.0 22 F 06/14/2001 Called clinic to report 1 hr post injection - muscle soreness in L arm and neck. Had fever 100.4F took advil, temp dropped to 99F. Restless noc headache & sore arm., this am T 102.4F, sore arm & severe headache. Pt admitted to having tightness in throat (hard to swallow when waking) on 6/5/01 partner had sore throat also. U 06/05/2001 06/05/2001 0 PUB OTH Sore throat O~Hep B (Recombivax HB)~1~20.00~In Patient 1
0173246 07/12/2001 CA 2.0 2 .6 M 06/25/2001 Red rash face, chest, arms, 15 min after vaccine. no temp, no resp distress no tx needed. Rash disappeared after several hrs. Y 06/25/2001 06/25/2001 0 NONE PUB PUB NONE NONE NONE CA010074 1
0173247 07/12/2001 CT 4.0 4 F 06/25/2001 L upper arm markedly swollen hot, red, tender; no fever. On 6/25/01 came to clinic for TB reading. U 06/22/2001 06/23/2001 1 NONE OTH PUB NONE NONE NONE CA010073 1
0173248 07/12/2001 CA 16.0 16 M 06/22/2001 3cm Indurational redness rt arm Y 05/07/2001 05/09/2001 2 None OTH PUB None None CA010072 1
0173252 07/13/2001 PA 32.0 31 F 09/10/2002 Following the reported onset of arthritis, the vaccinee experienced shortness of breath and chest discomfort. These were not reported as adverse events due to vaccine administration, but were found during the course of review of the vaccinee's medical records. Therefore they are not listed as adverse events. The pt received her 1st and 2nd injections of Lymerix on 3/2/99 and 4/6/99, respectively. The pt's attorney stated, "After receiving the vaccinations, (her) physical condition began to deteriorate. At first, the muscles in her arms and legs became painful. Her condition worsened and the pain increased and spread throughout her body." Onset of the muscle pain, as well as duration before worsening, was not provided. The vaccinee reportedly, underwent "extensive and intensive physical occupational, and rehabilitative therapies and modalities"; however, the "debilitating pain and arthritis throughout her entire body" allegedly persisted. The pt has also reportedly received "exercises/physical therapy regimens, antibiotic treatment and trigger point injections". The attorney stated that the pt continues to experience "incurable and at times debilitating pain", which "severely limited her employment options and opportunities". The attorney stated that the pt was told by her physician "that her physical problems were related to the Lymerix vaccinations." On 11/16/00, the vaccinee reported to her gynecologist that she had muscle, joint symptoms and PMS symptoms secondary to Lyme's. She stated that diagnosis of Lyme disease and granular/monocystic Ehrlichiosis were made on 9/1/00, after having symptoms for 3.5 years. At the time of the office visit with the gynecologist, the vaccinee was being treated with cefuroxime, doxycycline, pseudoephedrine/guaifenesin, and acidophilus. The most recent information received on 2/15/02, did not specify the outcomes of th reported events. The pt is considered disabled because of the "debilitating pain", which "severely limited her employment options and opportunities". The medical history included Lyme disease. On 03/26/1998, the vaccinee's gynecologist wrote, "Over the last year, she was treated for presumptive Lyme disease and couple of times with antibiotics; relief obtained each time." The medical history also included premenstrual syndrome treated with provera, Dyazide, and Zoloft; hot flashes, hair growh on upper lip, irregular menstual cycles, endometriosis treated with Lupron, abdominal adhesions, pelvic pain, ovarian cysts, and anemia. Surgical history included lapargscopy with lysis of right lower quadrant adhesions and fulgrationof endometriosis, cesarean section, and appendectomy at age 18. Following the reported onset of arthritis, the vaccinee experienced shortness of breath and chest discomfort. These were not reported as adverse events due to vaccine administration, but were found during the course of review of the vaccinee's medical records. Therefore, they are not listed as adverse events. On 11/16/2000, the vaccinee reported to her gynecologist that she had "muscle, joint" symptoms and "PMS symptoms secondary to Lyme's." She stated that diagnoses of Lyme disease and "granular/monocystic Ehrlichiosis" were made on 09/01/2000, "after having symptoms for 3.5 years." At the time of the office visit with the gynecologist, the vaccinee was being treated with Ceftin, doxycycline, Duratuss, and acidophilus. The most recent info received on 02/15/2002, did not specify the outcomes of the reported events. Other medical histories include mitral valve prolase; mitral regurgitation, pelpitations, edema of hands and feet, atypical chest pain, shortness of breath, joint pain, joint swelling, limb pain, back pain, fibromyalgia, fatigue, nause, and headache. On 03/24/1999, the vaccinee informed her dentist that she received care at a hospital, either as an out-patient or as an in-patient, within the previous two years for "shortness of breath from complications thoght to be from Lyme disease. She also indicated that she was or had been within the previous two years, under the care of a physician for illness thought to be lyme disease. She indicated that she had taken amoxicillin, Zoloft, ibuprofen, and trianterane/hydrochlorethiaside within the preceding six months for unspecified indications. The most recent info, received on 04/11/2002 did not specify the outcomes of the reported events. **Follow-up report on 10/10/02: The vaccinee received her 2nd injeciton of LYMErix on 4/6/99. At the time of this visit, she was complaining of shortness of breath, palpitations, tiredness, fatigue and was feverish. On 8/1/00, the vaccinee was seen by the vax provider. She complained of aches and swelling of four days duration, right sided chest pains, tiredness, sleeping a "long time", bad moods, and arthritis. The MD prescribed ibuprofen 600 mg three times daily and noted that a Lyme titer was negative. On 8/2/00, the vaccine presented to the local ER with complaints of chest pain for 2 days, shortness of breath, left arm numbness, left leg numbness, and lightheadedness for 5 days. She stated that she had been seen by her primary MD on 8/1/00. The ER MD confirmed this. The vaccinee's primary MD stated that complete blood count, erythocyte cadimentation rate, and uric acid concentration were w/in the reference ranges, rheumatoid factor and Lyme titer were negative (please see Lab data section for details re. diagnostic evaluations). At the ER, Lyme antibody screen was "presumatively positive". Lyme IgG and IgM Western blots were negative. The ER MD's impression was "Recurrent Lyme Disease" and he prescribed doxycycline. On 8/14/00, the vaccinee presented to another family MD for the first time. The MD noted that the vaccinee stated that she had possible Lyme infection in '96 with Lyme vaccine on 3/2/99 and again on 4/6/99. This was subsequently followed by the chief complaints listed at this visit as unexplained sweats and weight changes, fatigue, chronic sinus infections, pelvic pain, unexplained menstrual irregularities, irritable bladder, bladder dysfunction, decreased libido, stomach problems (NOS), chest pain, shortness of breath, heart palpitations, joint pain in multiple major joints, muscle pain, cramps, twitching of her facial muscles, headaches, neck stiffness, stiffness in the joints of her back, tingling numbness in her extremities, double vision, floaters, photosensitivity, buzzing, ringing in her ears, sensitivity to sound, dizziness, lightheadedness, difficulty with concentrating, reading or following plots, decreased short term memory, ,mood swings, irritability, depression, crying for no reason, sleep disturbances (NOS), and early awakening. Medications at the time of this visit included doxycycling 100 mg twice daily. Physical exam revealed a 6th cranial nerve palsy (greater on left than on right). Extensive diagnostic evaluation was negative, except for Lyme IgG and IgM Western blots, human monocytic ehrlichoisis (HME) IgG and IgM, and human granulocytic ehrlichiosis (HGE) IgM (please see Lab data section for details regarding diagnostic evaluations). The MD indicated that the Lyme serology(?) indicated "Lyme disease in the past more than 2 yrs" and "current infection of Lyme disease". On 9/5/00, the vaccinee was seen in follow-up by the family MD. The MD noted his impressions as myalgia, arthralgia, HME, and HGE. The vaccinee was given penicillin G benzathine (Bicillin LA) 2.4 million units IM and was prescribed cefuroxine exetil (Coftin) 500 mg twice daily. On 9/18/00, the vaccinee was again seen by the family MD. At that time, she reported some improvement in her symptoms. Her temp was 100.1 deg F. The MD noted that she had a "positive Herxheimer reaction". The MD continued treatment with Ceftin and added ciprofloxacin (Ciloxan) four drops 3 times daily." On 10/20/00, the vaccinee was seen by the fmaily MD. She reported, "I really feel improved", "I really don't have a headache now". She also reported that she had not perceived any changes to her "ocular sensations", "sounds seemed to be louder than normal" and her "heart fluttered". The MD noted his impression as hyperacusis, HME, HGE, Lyme disease, He continued Ceftin therapy and added doxycycline (Doryx) 100 mg daily. He encouraged the vax to begin walking on a daily basis to "boost her immune system". On 11/9/00, the vaccinee was seen by the family MD. She reported "having been doing everything which the MD noted made her sick. He advised the vaccinee "that when she starts to feel good, to take it easy, if she worked hard one day, to rest the next because it could bring on an exacerbation of her symptoms." The vaccinee also reported that she had been compliant w/walking, up to one mile daily, but had noticed an increased stiffness over the past month. The MD continued Doryx and Ceftin therapy and administered Bilcillin LA 2.4 million units. On 11/16/00, the vaccinee reported to her gynocologist that she had "muscle, joint" symptoms and "PMS symptoms secondary to Lyme's [sic]". She stated that diagnoses of Lyme disease and "granular/monocystic Ehrlichiosis" were made on 9/1/00, "after having Sx's for 3.5 yrs". At the time of the office visit w/the gynocologist, the vaccinee was being treated w/cefuroxine (Ceftin), doxycycline, psuedoephodrine/ guoifenasin (Duratuss), and acidophilus. On 12/5/00, the vaccinee was seen by the family MD. She reported improvement in her symptoms (NOS), but also complained of chest wall pain off and on in the sternal area as well as hearing prob's (NOS). She also stated that "maybe she had a virus this past month that was contributing to these maladies." The MD noted that the "chest wall tightness from what we have noted as a Herxheimer reaction where symptoms are exacerbated during the treatment and die off of the organisms of Lyme disease Borxelia." He continued treatment with Doryx and Ceftin. At the time of the visit he administered Bicillion 2.6 million units IM and prescribed dextromethorphan/ phemylpropanolamine/ brompheniramine (poly-Histine DM) to be taken one to 2 teaspoonfuls 4 times daily. On 1/2/01, the vaccinee was seen by the family MD. She reported that for the 1st time in about 4 yrs, the edema in her left fingers had resolved. She also stated that the chest pain had improved and overall she was doing much better. The MD noted hemangiomas increasing on her skin "which is seen w/Babesiosis". Ceftin and doxycycline were continued. On 1/8/01, the PT was evaluated by a cardiologist for mitral valve prolapse and chest pain. Her physical exam and echocardiography were normal. The MD noted that it had "become apparent that some of the chest pain may well be related to Lymes (sic) disease". On 2/26/01, the vaccinee was seen by the family MD. She reported that she had discontinued her antibiotics "a few days ago". She stated that "she was stable". The MD noted that her skin had cleared. The vaccinee telephoned the MD on 3/13/01 and reported that she "feels like she is going downhill. She is more tired, hands and face painful, legs feel heavy again, can't think and difficulty w/word finding". She also reported in increase in the following symptoms: fatigue, swelling, lower back pain, joint pain, stiff neck, and bad moods. Serologies for Lyme disease, babesiosis, and HME, performed as part of management on 3/12/01 were positive. On 4/3/01, the vaccinee was seen by the family MD. The vaccinee reported that around 3/15/01, she felt "like she is going downhill, ,more tired, hand and face painful, legs feel heavy again, can't think, difficulty with word finding". The MD noted that at this time the vaccinee had been off antibiotics about 3 wks. At the current visit, the vaccinee was complaining of ongoing muscle cramps and pain. The MD noted that acne had returned and prescribed "X Gel" 27 grams topically twice daily. On 5/7/01, the vaccinee was seen by the family MD. She reported "her bad days are fever and farther between", increased energy, decreased finger swelling, but still c/o'd daily pain, occasional headaches and increased neck pain. The MD discontinued Doryx and prescribed atovaquone (Mopron) 750 mg in the morning and 1500 mg in the evening for treatment of babesiosis. Coftin therapy was continued. On 6/7/01, the vaccinee was seen by the family MD. She reported that after treatment w/Mopron, "I have had the best week in 4 yrs". However, she stated that she had a "flare-up" while in the waiting room and that she still has sweats, chills, stiff neck, and quadricop weakness (treated with megnasium). Mopron was discontinued and treatment for Babesiosis was changed to atovaquone/ proquanil (Malarone) one tablet for 21 days then 4 tablets for 3 days. On July 12 01, the vaccinee was seen by the family MD. She reported that she had a "rough month" as she was experiencing depression because her daughter had been bitten by a series of deer ticks. She also reported that when she was on Malarone therapy, she suffered from increased depression. The MD gave her samples of bupropion hydrochloride (Wellbutrin ER), titrating from 75 mg daily to 150 mg daily, and referred her to a psychiatrist who works w/PTs with tick-borne diseases and depression. On 7/30/01, the family MD wrote a letter to the vaccinee's attorney summarizing his course of treatment, which has been described above. W/in the letter he noted: "Impression: 1) Lyme disease for more than 2 yrs, secondarily exacerbated by Lymerax [six] vaccine which I have seen in dozens of cases in the past. 2) Human Monocytic Ehrlichiosis. 3) Human Granulocyte Ehrliochiosis. 4) Babesiosis. 5) Depression secondary to all the above. Prognosis: At this point the prognosis is fair to good. The PT has responded well to the antibiotic and antiparasitic treatment. However, I want to reserve the fact that we do not know what the future will hold for this PT. The PT is problematic because we had taken her off her antibiotic regimen and basically has relapsed which makes her case quite perplexing." On 8/13/01 the vaccinee was "doing ok". However, the family MD prescribed naproxon (Napralan) 500 mg twice daily. On 9/10/01, the vaccinee was "better this month". The vaccinee returned to the family MD on 10/2/01, stating that she was "sick yesterday. Numbness arm elbow to ulnar off/on". The vaccinee was referred to a neurologist. On 10/29/01, she reported "increased neurological prob's: balance off". The MD noted "HLA-DKA-gene detected may be the reason for PT having increased prob's from Lyme vax". The most recent info, received on 9/24/02, did not specify the outcome of the reported events. The vaccinee is considered disabled because of the "debilitating pain", which "severely limited her employment options and opportunities". Y Y U 04/06/1999 08/01/2000 483 Absolute besophils, 6/8/01, result 59/cu mm, range 0-200; Absolute cosinophils, 6/8/01, result 118/cu mm; Absolute lymphocytes, 6/8/01, result 1147/cu mm, range 350-4100; Absolute lymphocytes, 6/8/01, result 1147/cu mm, range 350-4100; Absolute monocytes, 6/8/01, result 185/cu mm, range 200-1100; Absolute neutrophil count, 6/8/01, result 2294/cu mm, range 1500-7809; Albumin, Serum, 8/14/00, result 5.1 g/dL, range 3.5-5.0; Albumin, Serum, 11/9/00, result 5.1 g/dL, range 3.5-5.0; Albumin/Globulin ratio, 11/9/00, result 2.2, range 0.9-2.1; Antinuclear antibody, 8/1/00, result Neg; Antinuclear antibody, 8/14/00, result Neg, range <1:40; Babesia IgG Western blot, 9/14/01, result Neg; Babesia IgM Western blot, 9/14/01, result Neg; Babesia microti IgG, 8/18/00, result <1:40, range - <1:40; Babesia microti IgG, 3/12/01, result 1:40, range - <1:40; Babesia microti IgM, 8/18/00, result <1:16, range - <1:16; Babesia microti IgM, 3/12/01, result 1:40, range - <1:16; Bartonelia Mansalae PCR, 10/31/01, result Neg; Chlamydia sybtype by PCR, 10/31/01, result Neg; Creatiaine, ,Serum, 10/20/00, result 0.5 mg/dL, range 0.6-1.5; Cytomogalovirus PCR, 10/31/01, result Neg; Epstein-Barr PCR, 10/31/01, result Neg; Erythrocyte Sedimentation Rate, 8/1/00, result 4 mm/hr, range 0-20; Full blood count, 8/1/00, result normal; HGE IgG, 8/18/00, result <1:40, range <1:40; HGE IgG, 3/12/01, result <1:40, range <1:40; HGE IgM, 8/18/00, result 1:40, range <1:40; HGE IgM, 3/12/01, result <1:40, range <1:40; HLA-DR4 antigen, 10/29/01, result - Detected; HME IgG, 8/18/00, result 1:40, range <1:40; HME IgG, 3/12/01, result 1:80, range <1:40; HME IgM, 8/18/00, result 1:40, range <1:40; HME IgM, 3/12/01, result 1:80, range <1:40; Hep A antibody, 8/14/00, result Neg; Hep B core antibody, 8/14/00, result Neg; Hep B core antibody IgM, 8/14/00, result Neg; Hep B surface antibody, 8/14/00, result Neg; Hep B surface antigen, 8/14/00, result Neg; Hep C antibody, 8/14/00, result Neg; Hep E antibody, 8/14/00, result Neg; Hep F antibody, 8/14/00, result Neg; Herpes simplex 1 PCR, 10/31/01, Neg; Herpes simplex 2 PCR, 10/31/01, result Neg; Human Herpes type 6 PCR, 10/31/01, result Neg; Human Herpes type 8 PCR, 10/31/01, result Neg; Lyme IgG Western blot, 8/2/00, result Neg; Lyme IgM Western blot, 8/2/00, result Neg; Lyme PCR, 3/13/01, result Neg; Lyme antibody ELISA, 3/2/00, result 1.60, range <0.91 - 1.09; Lyme antibody screen, 3/22/99, result <0.8, range <0.8; Lyme antibody screen, 8/1/99, result <0.99, range <0.99; Lyme genomic PCR, serum, 8/18/00, result Neg; Lyme genomic PCR, serum, 3/12/01, result Neg; Lyme genomic PCR, whole blood, 8/18/00, result Neg; Lyme genomic PCR, whole blood, 3/12/00, result Neg; Lyme plasmid PCR, serum, 8/18/00, result Neg; Lyme plasmid PCR, serum, 3/12/01, result Neg; Lyme plasmid PCR, whole blood, 8/18/00, result Neg; Lyme plasmid PCR, whole blood, 3/12/00, result Neg; Lyme titer, 8/1/00, result Neg; Lyme urine antigen, 3 samples, 9/22/00, result neg; Mycoplasma general PCE, 10/31/01, result Neg; Platelet Count, Blood, 12/5/00, result 147 thous, UL, range 150-400; R. rickettsil IgG, 8/23/00, result <1:64, range <1:64; R. rickettsil IgM, 8/23/00, result <1:64, range <1:64; R. typhi IgG, 8/23/00, result <1:64, range <1:64; R. typhi IgM, 8/23/00, result <1:64, range <1:64; RBR screen, serum, 8/14/00, result - Nonreactive; Rheumatoid factor, 8/1/00, result <20 IU/mL, range <20; Uric Acid, Serum, Jan 00, result 1.7 mg/dL, range 2.2-6.8; Uric Acid, Serum, 8/1/00, result Normal; Uric Acid, Serum, 12/5/00, result 1.7 mg/dL, range 2.2-6.8; White blood cell count, 10/20/00, result 3800 cu/mm, range 3900-11400; White blood cell count, 6/8/01, result 3700 cu/mm, range 3800-11400; human immunodefiency virus t, 2/26/01, result nonreactive; Lyme IgG Western blot, 8/18/00: result Pos, 23-25, 30, 39, 41, 93 kD bands present; Lyme IgM Western blot, 8/18/00: result Pos, 31, 34, 37, 39, 41, 58, 66 and 93 kD bands present; Lyme IgG Western blot, 3/12/01: result Pos, 30, 31, 39, 41, 45, 66 and 93 kD bands present; Lyme IgM Western blot, 3/12/01: result Pos, 39, 41, 45, and 93 kD bands present; PVT OTH Guasphenesin+pseudoephedr, Lact, acid-producing orgs, Amoxicillin trihydrate, sertraline hydrochloride, Ibuprofen, Triamterene HCTZ Fever Abdominal adhesion, Anemia, Appendectomy, atypical chest pain, back pain, casarian section, endometriosis, hair growth on upper lip, hot flash, irregular menstrual cycle, laparoscopy, lyme disease, lysis of adhesions, abdominal adhesion, ovarian cyst, pelvid pain, premenstrual syndrome, mitral valve prolapse, mitral regurgitation, palpitations, edema of hands and feet, atypical chest pain, shortness of breath, joint pain, joint swelling, limb pain, back pain, fibromyalgia, fatigue, nausea, and headache, mild allergy (spring/fall), wisdom teeth removal. Weight fluctuations. 20010164131 1
0173257 07/13/2001 CA 0.5 0 .5 M 06/27/2001 Apparently, child experienced fever to 102F-103F later in the day, post vax, and was crying inconsolably and also had vomiting and diarrhea with symptoms. All occurred within 6 hours after receiving immunizations. Pt taken to local ER and admitted due to high white count (23,800) and for rule out of sepsis. Dx'd with possible viral syndrome; possible reaction to immunizations. Y Y 1 Y 05/21/2001 05/21/2001 0 WBC count done on 05/21/2001 was 23,800 with polys 73 bands 5 lymphs 17 OTH PUB NONE NONE NONE CA010075 1
0173258 07/13/2001 OR 13.0 13 M 06/20/2001 2/19/01 severe headache, temp, flu sx times 1 wk, tx for infection w/antibiotic, No resolution. Missed most of school between 2/19 to 3/01 MRI #1 R/O encephalitis, overnight hospitalization @ Emmanuel Legacy, Portland. 3/23-3/30/01 hospitalization @ hospital R/O migraines. No resolution from either hospitalization. Headaches progressively improved; still occurring but are not interfering with daily living. Rx: Zoloft 150mg currently decrease dose Depakote d/c 2 wks ago, Zanaflex d/c 1 wk ago. Y Y 9 Y Y 02/06/2001 02/19/2001 13 Blood work; spinal tap, MRI x 2 all WNL PUB PUB NONE 1/5,22,23,31/01 missed school feeling lousy. 2/6/01 not ill. NONE OR200126 1
0173259 07/13/2001 MD 18.0 18 F 07/10/2001 On 6/8/01 PM, pt had sudden onset of severe right upper chest pain; was taken to ER and developed hypotension, severe abdominal pain and vomiting. She was Rx'd with dopamine IV antibiotic fluids and transferred to ICU. In 10 to 12 hours, weaned off pressors; fever resolved and discharged home on po antibiotics after 3 day stay. Y Y Y 3 Y 06/04/2001 06/08/2001 4 VQ Scan/CT of chest, abdomen, pelvis and U/S of pelvis; CBC; Chem Panel; Urine Cx. PVT PVT NONE NONE Allergic to Sulfa 1
0173260 07/13/2001 NY 32.0 32 M 07/08/2001 Went to hospital; said I was acting jittery; more or less because of periodic moments when I was suppose to be docile. Asked me questions, yet they were not satisfied with the answers. Therefore, asked for urine but couldn't urinate; they persisted, I insisted. They then said and injected me with PCP and gave me no acknowledgement of the vaccine. I heard this from the outpatient dept referral request form after ordered. I was administered for these jittery symptom because I had a few drinks and stayed up all night; making me jittery. Y Y 06/22/2001 PUB OTH NONE NONE NONE 1
0173261 07/13/2001 WI 1.7 1 .7 M 07/06/2001 On 06/30/2001 the patient was seen in the ER. The patient had fallen from the couch to the floor, was irritable, and would not bare weight on the left leg. On 06/30/2001 the patient developed erythema in an area 7.2 x 4.5. Y U 06/28/2001 06/29/2001 1 PVT PVT NONE Mosquito bite right arm Left club foot, heart murmur 1
0173262 07/13/2001 OK 0.2 0 .2 M 07/09/2001 Eight hours after receiving vaccine, the patient was in bed and was fine. The patient suddenly screamed. The parents went in and found the patient limp, pale and somewhat cyanotic. The patient was taken to the ER and seemed well. Y Y 07/03/2001 07/04/2001 1 PVT PVT NONE NONE NONE 1
0173263 07/13/2001 NH 0.5 0 .6 F 07/09/2001 On 07/07/2001 the patient experienced a fever of 101F with redness and swelling, approximately thumb sized, at the injection site. That PM the patient noted an increase in the redness and swelling, and was fussy. The patient was treated with Tylenol for the fever and discomfort and with Benadryl. Y 07/06/2001 07/07/2001 1 PVT PUB NONE NONE Constipation 1
0173441 07/13/2001 AK 14.0 14 M 07/06/2001 Pt developed pruritic rash 1 hour post vax. Y U 07/05/2001 07/05/2001 0 NONE PUB PUB NONE NONE NONE 1
0173442 07/13/2001 GA 4.5 4 M 07/05/2001 Redness at site of DTAP - swollen, zero s/sxm of cellulitus LL Y Y 07/02/2001 07/03/2001 1 PVT UNK NONE NONE Autism 1
0173443 07/13/2001 SC 17.0 17 M 06/29/2001 Less than 30 minutes after receiving vax, pt experienced symptoms of slow speech, head felt like it was jerking, arms felt heavy. By 7 PM (4 hrs), pt had fully recovered and was symptom free. Y 06/28/2001 06/28/2001 0 NONE PUB PUB NONE SC0137 1
0173444 07/13/2001 SC 4.0 4 F 07/02/2001 More than 48 hrs post vax, pt developed generalized macular, patchy rash. She had minimal itching. At date of report, face looks slightly puffy with rough skin. Pt taken to ER on 7/1/01 and given Benadryl. She had appt with MD on 7/2/01. Y Y 06/28/2001 07/01/2001 3 PUB PUB NONE NONE NONE SC0136 1
0173445 07/13/2001 SC 11.0 11 F 07/02/2001 Fever started 6:00 pm 6/29/01 zero actual temperature taken per mom. Tylenol given. Fever over weekend, mom states daughter is irrrtable and uncomfortable and complains of sore throat. Motrin givens relief. Encouaged PMP visit ASAP U 06/29/2001 06/29/2001 0 NONE PUB PUB NONE NONE NONE SC0135 1
0173446 07/13/2001 CT 1.0 1 .0 F 07/04/2001 Pt developed local swelling, erythema and single vesicle at site of injection in right thigh. Y Y 06/25/2001 07/02/2001 7 PVT PUB NONE NONE Cranial synostosis repaired 10/13/00 1
0173447 07/13/2001 MI 4.0 4 M 07/05/2001 Dt vaccine administered 6/26/01. Slight temp 06/27/2001 and loss of appetite. Rash on 06/28/2001 l leg. Confirmed by pediatrician 06/28/2001 allegic reaction. Tx cold compress and benydril. rash subsided 06/30/2001. Y 06/26/2001 06/28/2001 2 PVT UNK none none sulfa. Pediazol. tylenol 1
0173448 07/13/2001 PA 8.0 3 M 07/03/2001 Varicella vaccine given 11/25/1996. Pt developed varicella with over 100 pox 7/3/01. Y 11/25/1996 07/03/2001 1681 NONE PVT PUB Ritalin NONE NONE 1
0173449 07/13/2001 MA 6.0 6 M 06/06/2001 Has erythema, tenderness, swelling-unduration and redness on left upper arm. 48 hours after immunization given motrin and benadryl. zero resp distress Y U 06/04/2001 06/04/2001 0 NONE PVT UNK NONE Asthma, febrile seizures 1
0173450 07/13/2001 MD 61.0 61 U 07/09/2001 Pt developed redness, swelling and a "bullseye" effect surrounding injection site. She also had an ache. This lasted from 6/26/01-7/80/01. Y 06/26/2001 07/04/2001 8 PVT PVT Fosomax, Prempro NONE NONE 1
0173451 07/13/2001 IA 9.0 9 F 07/12/2001 Pt developed fever within 1 hr post vax up to 102 degrees. Pt febrile 18 hrs post vax administration. Pt also had pain and swelling involving right deltoid (site of vaccine). Pt treated with Ibuprofen 200 mg po q6-8hr PRN. Y U 07/11/2001 07/11/2001 0 NONE PUB PUB NONE NONE 1
0173452 07/13/2001 MA 33.0 33 M Pt developed urticaria and itching on bilateral arms, trunk and legs 2 days post vax. Pt also had a laceration on hand requiring sutures. Pt was treated with Benadryl and prednisone. Y 07/09/2001 07/11/2001 2 PVT OTH NONE NONE 1
0173453 07/13/2001 TX 43.0 43 F 07/11/2001 Pt developed fever and flu-like symptoms post vax. Pt developed erythema to site. She was instructed to take Advil and return to MD for lab draw. Y U 07/10/2001 07/10/2001 0 CBC PVT OTH NONE NONE NONE 1
0173264 07/16/2001 LA 0.09 0 .1 M 07/09/2001 On 6/22/01, pt received Hep-B and 1 hour later, he had rapid breathing. Two hours later, he had increased fever and was lethargic with malaise. On 6/23/01, he was admitted to the hospital with increased fever. His appetite was somewhat decreased. Exam completely normal. Y 5 Y 06/22/2001 06/22/2001 0 spinal tap,CBC with diff, Basic Metabolic Panel, Blood C&S, Cath UA, and Chest x-ray PVT PVT NONE Eczema NONE 1
0173266 07/16/2001 HI 0.38 0 .4 M 07/06/2001 Generalized tonic-clonic seizures - Ativan, Phenbarb, fever 101.8F - ICU admission. R otitis media. Per follow up report-Epilepsy, intractable, mixed type. A temperal, but not necessarily caused, relationship has been established between the above vaccinations and the patients seizures. The shots were the second set received. Subsequent seizure episodes were usually, but not always, heralded by febrile viral illness. Y Y Y N 07/05/2001 07/05/2001 0 CBC, electrolytes, Ca, P04, glucose, LP, all WNL PVT PUB NONE NONE NONE 1
0173267 07/16/2001 MD 4.0 4 F 06/01/2001 Child awoke from nap and fever 102F, swelling and redness on right deltoid. Child seen in health dept at 16:30 PM. Mom reports fever broke shortly after getting up from nap. Redness noted on right deltoid 5 cm in diameter. No swelling. Area warm and tender. Y 05/29/2001 05/31/2001 2 NONE PUB PUB NONE NONE NONE MD01004 1
0173269 07/16/2001 GA 1.2 1 .2 M 07/04/2001 After receiving MMR, within 4 days, lost all speech, was in his own world, no eye contact, no interaction, loss appetite, went into zombie-like state, fussy and had diarrhea. Dx'd with autism and PDD. Y N 07/08/1998 07/12/1998 4 PVT PUB NONE NONE NKA Reaction unevaluable~Measles + Mumps + Rubella (no brand name)~1~1.00~In Patient 1
0173270 07/16/2001 PA 1.2 1 .2 M 07/01/2001 Autistic symptoms (toe walking appeared deaf, temper tantrums, loss of already acquired speech) Confirmed autistic on 8/29/00. Y N 12/01/1998 12/15/1998 14 PVT PVT NONE 1
0173271 07/16/2001 NY 37.0 37 F 07/10/2001 Onset of "treatment resistant" Lyme arthritis within weeks of "first injection, worsened after 2nd injection. Extreme pain in right knee, hip, neck and hand. Only partial use of right hand. Difficulty on 5/16/01 through 6/13/01 walking. Y N 05/16/2001 05/25/2001 9 UNK UNK NONE Seasonal allergies 1
0173333 07/16/2001 GA 3.6 3 M 07/13/2001 6 X 7cm area of erythema right anterior thigh, 9 X 11cm area of erythema left anterior thigh. No induration, pain or tenderness, only minimal swelling. No fever. Pt cooperative and not fussy or in pain. Y Y 07/10/2001 07/10/2001 0 NONE PVT PUB NONE NONE 1
0173334 07/16/2001 OH 0.2 0 .2 M 07/09/2001 Pt was mistakenly given an MMR 07/09/01, 10:30. No reaction occurred. Y 07/09/2001 NONE PVT PVT NONE NONE NONE 1
0173335 07/16/2001 CT 1.25 1 .3 M 07/09/2001 Right arm at vaccine site, became swollen and indurated. Fever of 102F, 3 days later. Resolving to small area of hardness at site. Y 07/06/2001 07/07/2001 1 NONE PVT PVT NONE NONE NONE 1
0173336 07/16/2001 IL 0.3 0 .3 F 07/09/2001 4 hours, post vax, baby suddenly lay still, rolled eyes and fell asleep for 1/2 hour and then woke up screaming, lasting for 2 hours. 12 hours later, temperature was 101.4F to 102.9F for 12 hours and then loose stools but was alert and happy. Y 07/02/2001 07/02/2001 0 PVT PVT NONE NONE NONE 1
0173337 07/16/2001 LA 0.6 0 .6 F 06/28/2001 Pt reported that she had eye swelling and was given Benadryl and Tylenol ATC. Pt was immunized at 17:00 and onset was 21:00 (4 hours total) and swelling lasted about 1 day, per father's report. Y 06/20/2001 06/20/2001 0 OTH OTH NONE NONE 1
0173338 07/16/2001 CA 1.2 1 .1 F 07/06/2001 Rash; generalized pimple-like and red on chest to stomach with fever and itching. Pin-prick skin color at site of injection. Mother thinks due to allergy to alcohol wipes; happens each time at each site with previous vaccines. Y 04/20/2001 04/21/2001 1 PVT PUB NONE NONE Rash~Vaccine not specified (no brand name)~~0.00~In Patient 1
0173339 07/16/2001 IL 1.2 1 .2 F 07/09/2001 Pt was taken to ER on 7/2/01 by EMS because of high fever (?) no measured. Y Y 06/30/2001 07/02/2001 2 PVT PUB NONE NONE 1
0173340 07/16/2001 NC 0.4 0 .4 F 06/29/2001 Mother states, 4 days, post vax, infant had greenish diarrhea stools; 6 days, post vax, had a fever of 104F (ax) during the day and treated with infant Tylenol. That night infant had episode of body stiffness with hands clinched, temp was 100.9F at this time. Mother did not take infant to the doctor. States infant was okay, the next day. New to area, does not have local doctor. Encouraged to obtain doctor. Update, has local doctor now. Y 06/21/2001 06/27/2001 6 PUB PUB NONE NONE 1
0173341 07/16/2001 MI 4.0 4 M 07/09/2001 Gait deterioration; slapping gait; speech deterioration and lethargy within 36 hours of vaccine. Y 07/05/2001 07/06/2001 1 PVT PVT Extendryl 1 tsp every day NONE Arrested Hydrocephalus, Speech disorder, Diplegia 1
0173342 07/16/2001 CA 15.0 15 F 07/10/2001 Pt had a headache and fainted after shot. The following day, she had paralysis of left side of face. Treatment was to lay down; take antiviral medicines for 5 days and steroid medicines for 10 days. Y Y 01/01/2001 01/02/2001 1 Neurologist consult; Cat Scan; Physical exam PVT UNK NONE NONE NONE 1
0173343 07/16/2001 PA 1.2 1 .2 F 06/28/2001 S 2 Zoster complicated by superinfection. Y Y 10/16/1996 03/18/2001 1614 OTH OTH PA0152 1
0173360 07/16/2001 PA 5.0 5 M 06/22/2001 Child had shots at 10:00-10:05 and at 10:12, he became diaphoretic and pale and vomited a large amount X 2. At 10:15, his BP-80/40, P-70 and R-32, eyes open but not responsive to verbal stimuli. At 10:20, BP-90/50, P-70 and R-30 and shallow, color sallow, eyes open and starting to respond to verbal stimuli. Paramedics were called immediately and arrived at 10:20 and transported father and child to ER for evaluation X 2 hours. Telephone call to parents and they report child is well. Y Y 06/19/2001 06/19/2001 0 PUB UNK NONE NONE NONE PA0151 1
0173361 07/16/2001 HI 4.0 4 M 06/29/2001 Developed right leg swelling from site of shot down to knee with limping which occurred over 24 hour period. Y U 06/28/2001 06/28/2001 0 ESR-1; CBC-benign PVT PUB Zyrtec HI0106 1
0173362 07/16/2001 GA 4.0 4 F 07/20/2001 Right arm swollen and red. Y Y 07/05/2001 07/07/2001 2 PVT PVT NONE 1
0173363 07/16/2001 NY 4.0 3 F 07/10/2001 On day of vaccines, quarter-sized red area on left thigh. By evening at 20:30, had 5"-6" diameter round red area with rash surrounding and itchy at site of left thigh (DPTA or MMR). On 7/10/01, still with 5"-6" area faded rash at left thigh. (Per mother's statement". Y 07/05/2001 07/05/2001 0 PVT PVT NONE 1
0173364 07/16/2001 ME 1.25 1 .3 M 07/10/2001 3 days, post vax, pt had rash, swollen leg, fussy but of normal gait X 2 days. Evaluated on 6/28/01. Y Y 06/25/2001 06/27/2001 2 PVT PUB NONE NONE Left ear tag 1
0173365 07/16/2001 CA 1.5 1 .5 F 07/09/2001 Vaccine given on 10/6/00. On 7/6/01, pt developed a mild case of varicella. Y 10/06/2000 07/06/2001 273 NONE PVT PVT NONE NONE NONE 1
0173366 07/16/2001 IL 3.0 3 F 07/11/2001 Erythema multiforme Y 07/03/2001 07/05/2001 2 NONE PVT UNK 1
0173367 07/16/2001 NC 24.0 24 F I started Anthrax 1, 2 and 3 in the states and I noticed that I gained 4 pounds. Out of the states, I had the 4th and 5th Anthrax. With the 5th shot, I had a cellulite and keep gaining weight. In 3/00, I had the 6th Anthrax and still gaining weight. I gained a total of 27 pounds since 9/98 to 4/00. Until today, I still work out, everyday to loose that weight. It's been hard. Y N 03/17/1999 09/15/1999 182 NONE MIL MIL NONE Sulfa allergy on 4/98 1
0173368 07/16/2001 NV 47.0 47 F 07/09/2001 Neck, back and head began throbbing and "spasms" at 14:00. Felt "hot and cold" about 15:00. At 16:00, body aches started. "This was not one of my normal headaches." Began vomiting at 19:00. Went to ER at 22:00, due to pain and vomiting. Given shot to stop vomiting and IV fluids. No temperature per pt. Missed work on 7/8/01 and possibly today, 7/9/01. Released from ER after IV and injection. Pt states nausea and weakness continue but no vomiting. "I feel like my liver's been attacked. I used to drink, so I know." "Everybody ate the same thing I did and nobody else got sick. I'm the only one." Y U 07/05/2001 07/07/2001 2 NONE PUB PVT Synthroid, Vicoprofen, Estratest NONE Graves' Disease 1
0173369 07/16/2001 UT 4.0 4 M 07/06/2001 Fever of 103F (Ax) at 23:00 (11 1/2 hours, post vax) X 24 hours. Treated with ibuprofen. Had redness and swelling of right arm, deltoid area, noted on 7/5/01. This was 6cm long axis of arm X 4cm across. Y 07/03/2001 07/03/2001 0 NONE PUB PUB NONE NONE A hearing problem in left ear; eardrum retracted 1
0173370 07/16/2001 CT 6.0 6 M 07/06/2001 Left eye edema, burning sensation in nose; nasal obstruction. Y Y 07/06/2001 07/06/2001 0 PVT UNK NONE NONE 1
0173371 07/16/2001 CA 0.3 0 .4 F 07/06/2001 Fever, 8 hours, post vax, of 101.3F and emesis X 1. On 6/30/01, had malaise and vomiting. On 7/1/01, was weak and quiet. On 7/2/01, tongue deviated to right side and drooling. Choking on saliva and poor tongue coordination with talking. U 06/29/2001 06/29/2001 0 PVT PVT 1
0173372 07/16/2001 CA 4.0 4 M 05/09/2001 On 5/7/01, at 20:00, complained of pain of left thigh, swelling and redness, felt warm and did not feel well. On 5/8/01, pt did not want to walk on leg due to pain with increased swelling and redness. On 5/9/01, was able to walk. Y 05/07/2001 05/07/2001 0 PVT PUB NONE NONE NONE 1
0173373 07/16/2001 NC 4.0 4 M 07/13/2001 Edema, erythema, warmth and tenderness at right deltoid. Y U 07/11/2001 07/12/2001 1 PVT PUB NONE Allergy to Cefzil 1
0173272 07/17/2001 NY 0.2 0 .2 M 07/10/2001 Pt succumbed to Sudden Infant Death Syndrome (SIDS) 1 day post vax. Confirmed by autopsy results. Y 07/04/2001 N 07/03/2001 07/04/2001 1 NONE PVT PUB Tylenol Rx written day of vaccines NONE NONE 1
0173275 07/17/2001 LA 0.16 0 .2 M 07/01/2001 Pt developed same symptoms as twin brother. Y Y 3 Y 03/08/2001 03/08/2001 0 PVT PVT NONE 1
0173276 07/17/2001 MD 27.0 26 M 07/12/2001 Acute inflammatory demyelinating polyneuropathy for about 3 months. Treated with IVIG and physical therapy. Y Y Y 21 Y 05/22/2000 06/24/2000 33 Nerve conduction velocity; Spinal Tap PVT PVT 1
0173277 07/17/2001 WI 1.0 1 .0 F 07/10/2001 Two days post vax, pt was brought to hospital/clinic for decreased appetite/irritability. Then pt developed "respiratory distress." She was diagnosed with bacterial pneumonia and was hospitalized for 3 days. Then pt returned and was diagnosed with viral pneumonia. She had complications (partial collapsed lung) and was hospitalized for 3 days. Y Y 6 Y 03/05/2001 03/07/2001 2 PUB UNK Multivitamins with fluoride NONE NONE 1
0173279 07/17/2001 CA 74.0 74 F 07/11/2001 A nurse reported that a 74 year old female received a dose of Pnu-Imune 23 vaccine on 6/28/01. On 7/2/01, she developed an injection site reaction characterized by redness and swelling which extended to the elbow. The pt was prescribed Benadryl and antibiotics. On 7/9/01, the pt was hospitalized with palpitations. No further information was available at the date of the report. Y U 06/28/2001 07/02/2001 4 UNK PVT OTH Celexa, Detrol, Premarin, Valium NONE UNK HQ3104311JUL2001 1
0173288 07/17/2001 TX 2.0 0 .5 M 08/14/2002 Developmental history revealed that the vaccinee appeared to be "developing normally and talking in single words in a meaningful way until about 2 years of age." The physician who made the dx of pervasive developmental disorder stated, "His immunizations are up-to-date and he has had no bad reactions to them." Speech delay was 1st documented in medical records of the PCP on 12/14/99, when the child's mother left a telephone message concerning her son's speech delay problem and the need for a referral. On 1/3/00, a phone message was left for the PCP concerning the pt's speech delay and hearing problems and the need for referral. The child underwent an audiological evaluation on 2/8/00. The right revealed a flat tympanogram, consistent with effusion, but since his positioning was poor and he was moving and crying there is a large margin for error". The child underwent a communication evaluation on 2/9/00. The pt reportedly uses mostly single words, does not speak in sentences, will no respond or answer back to questions, sometimes is hard to understand and that he seems to miss the first word of sentences when he tries to talk. The mother stated that the child stopped talking at age 2, then when the family relocated he "stopped progressing, that once a skill was "mastered" he would not repeat it." His play behaviors were repetitive actions. He attempted to push small toys up his nose. He tends to lick things frequently. He tends to laugh for no reason. Toilet training had been coming along well, but then stopped. His sleep is characterized by frequent waking at nighttime. He had atypical social interactions. Subsequently, the parents of the pt alleged that the pt developed the "neurologic effects of mercury poisoning" as a result of being vaccinated with thimerosal-containing vaccines. As of 7/5/01, the outcome of the pervasive developmental disorder was unknown.F/U the most recent info was rec'd on 9/14/01. As of 5/14/01, the pervasive developmental disorder and autism were ongoing. The outcome of the mercure poisonign was unknown pervasive developmental disorder, autism and mercury poisoning are considered medically serious. 5/16/01 occupational therapy evaluation: the peabody developmental motor scales II instrument provided the following results:basal age (lower skill level) grasping 11-16months, visual 19/22 months. ceiling age (highest skill level) grasping 41-48 months, visual motor 25-28 months. Ths sensory profile instrument provided the following relsuts: probabble difference in touch processing, modulation related to body position and movement, modulation of movement, affectin level, modulation of sensory input affecting emotional responses, modulation of visual imput affecting emptional responses and activity level, definite difference in auditory processing, vestibular processing, oral processing, emotonal/social responses behavioral outcomes of sensory processing. The Easter seals ADL chesklist instrument revealed delays in dressing, grooming and toileting. F/U states, On 5/17/00, the child was seen by a physician specializing in "integrative treatments". The physician noted "hyperactivity", perenial allergies and speech delay. He has several deficiencies; he has parasites; heavy metal toxicity and nutritional deficiencies. The mother was instructed to decrease milk and egg whites in the child's diet. Unspecified supplements were dispensed. On 6/15/0, a 10-day course of nystatin was prescribed for an unspecified indication. Seen by this doctor on 7/19/00 and he noted "He started taking his supplements and has some difficulty eating a lot of food. His bowel movements have slowed down to a couple a day. He went over again the toxicity problem. We should go ahead and proceed with the urine challenge prior to starting chelation and urine DMSA. On 8/16/00, UTE screen "post provocative challenge" showed an elevated tin concentration. Mercury concentration was below the detection limit. A letter written by the child's father on 8/16/00 stated, "Simply put, (he) suffers from mercury poisoning whose characteristics are strikingly similar to autism related disorders". This letter was signed by the physician. On 11/13/00, UTE screen showed elevated concentrations of lead, mercury and tin. After seeing child on 11/30/00, the doctor stated we need to continue chelation and also we should consider exploring the amino acid, fatty acid dysfunction. On 2/15/01, the child was seen and is doing well with the chelation; has minimal nasal discharge. Cut back to 70 g X 2 a day for 3 weeks. On 4/10/01, he has increased hyperactivity and the previous abnormal behaviors to a greater extent. F/U states: The child began speech and language therapy on 4/4/00. He began twice weekly occupational therapy sessions on 6/19/01. In the pathologist's session note of 7/31/01, she wrote, "Dad reported (the child) is starting to have "his own thoughts", "answering questions". The child's mother reported that three cousins had unspecified "speech problems," one cousin had attention deficit disorder, and one aunt had an unspecified mental illness. Also adds that on 06/15/2000, the integrative treatments physician prescribed a 30-day course of nystatin to treat "an intestinal yeast overgrowth." On 08/18/2000, the child underwent a special education evaluation by his local public school district. At that time, his mother reported that "he has a previous diagnsis of pervasive developmental disorder, but this has since been changed to mercury poisoning and severe food allergies which cause similar characteristics." His mother wrote," since begining an organic diet with numerous supplements two months agi, we have seen a dramatic change in eye contact and interaction with others and an increase in vocabulary - using verbs, pronouns and putting words together." The mother indicated that the child communicated most of the time with gestures, single words, and two words together. She reported that his family members understood 75 % of what he said and strangers understood 50% of what he said. The child was "trained for urinating, but has trouble controlling bowels - refuses to go on potty. Supplements cause him to have very loose stools." The child drank from a cup, which or without a lid; fed himself with his fingers, a fok, and a spoon; undressed without assistance, took off his shoes and washed and dried his hands. The child was evaluated using a transdisciplinary play-based assessment, the childhood autism rating scale and the Gillian autism rating scale. His score on the childhood autism rating scale was 30, which on the rating scale was the borderline between "non-autistic" and "mildly-moderately autistic." His autism quotient on the Gillian autism rating scale was 82, which placed him in the "below average probability of autism" group. The evaluators found that the child was "age-appropriate in the ares of self-help and gross motor skills. He demonstrates qualitative impairment in social interactions and communication. In addition, some disruptions in sensory responses and play and interaction with materials and toys were observed. These behaviors may be consistent with an autism spectrum disorder. He shows an educational need for special education services because preschoolers received and express a large amount of information about themselves and their environment through communicaiton, social interactions, and learning from a variety of materials, and are therefore at a disadvantage when these abilities are delayed. It is recommended that he attend the preschool to be provided two hours per week within the classroom time." The evaluators certified that the child qualified for special education services on the basis of three "identified disabilities"non-categorical early childhood speech impairment, othe rhealth impairment." On 09/06/2000, the physician completed a physical disability, eligibility report, indicating that the child had "limited strength, vitality, or alertness due to chronic or acute health problems which adversely effect his educational performance." The health problems was noted as "heavy metal toxicity" which caused moderate impairment. The function implications of the impairment were reported as "difficulty with self-help skills, difficulty performing activities found in a general classroom, adaptation to the general program, difficulty to maintaining alertness in the general classroom, and difficulty with the short-term memory." The child participated in the preschool program for children with disabilities from 09/13/2000 to 09/11/2001. As of the September 2001 assessment, he had mastered 12 of the 22 short-term objectives defined at the beginning of the program and was close to mastering an addtional seven short-term objectives. The school district recommended that the child remain in the preschool program for the September 2001 to September 2002 school year, but extended to the full-day program. The most recent information was received on 01/30/2002. As of 09/13/2001, the pervasive developmental disorder and autism were ongoing. The outcome of the mercury poisoning was unknown. The follow-up states that MRI of the brain was performed on 06/08/2001; the radiologist's impression was "normal brain pattern." Overnight electroencephalography was performed from 07/23/2001 to 07/26/2001. The neurologist's impressions were "abnormal videoelectroencephalography monitoring demonstrating spikes and sharp waves fromt the right frontocentral region. This EEG emonstrates emilantiform activity. No clinical seizures were noted. A pattern of Landau-Klaffner was not seen." DNA probe analysis for Fragile X syndrome was negative on 08/07/2001. Amino acid concentration measured to 08/07/2001, were within the reference ranges, with the exception of a reduced concentration of valine. On 08/10/01, the child returned to the pediatric neurologist. The neurologist wrote that the child "is a 4 year, 11 month old boy wiht autism. He underwent a neurologic work-up in June and July. An MRI brain is normal. Overnight epilepsy monitoring for sleep EEG is abnormal with occasional generalized spike and wave. The pattern is not consistent with Landau-Kleffner syndrome. Serum chemistries are normal except for a platelet count of 15,000. Large groups of clumped platelets suggest that the platelet count is falsely low. His examination remains unchanged. Recommendations: 1. discussed the nature of the abnormal EEg with his parents. Although the EEg pattern is not suggestive of LKS, I have offered the parents an empiric trail with either an anticonvulsant medication or oral prednisone. Potential side effects of each therapy were discussed. The pt's father is not interested in such therapy with, admittedly, unlikely benefit." The most recent info was received on 06/25/02. As of 09/13/01, the pervasive developmental disorder and autism were ongoing. The outcome of the mercury poisoning was unknown. The follow up states family history was significant and one aunt had depression. On 5/24/02 and 6/14/02, the subject was evaluated by a pediatrician for "a second opinion for treatment." The pediatrician took an in depth new pt history from the subject's father. The subject's current medications included an unspecified nabulizer for breathing as needed and multivitamins and mineral supplements. He was receiving occupational and speech therapy. When the subject's father was questioned regarding immunizations and reactions, he indicated there were "one or two times that he might have had a problem." The subject was still for the most part on a gluten-and-caseine-free diet with "some" wheat and dairy. At the time of the evaluation, he was able to use a spoon, fork, and cup without a lid. He was not toilet trained. The father reported that the subject "has leaky gut" with yellow stools. It was noted that the subject "now has hundreds of words." However, he could not tell a story or carry on a conversation. The subject liked to be red to, recognized other words, looked at books "independently," recognized the alphabet and recognized his name. The subject could draw shapes and print his name with assistance. He knew numbers from one to 36. His father indicated that he "obsessed" on videos and books. His father ntoed he could build with Lego's and his stacks had to be even and very meticulous. His gross motor skills were "phenomenal" and his fine motor skills were weak. He overreacted to loud sounds. His father stated his son "began to withdraw then had more issues with screaming. Now he has on and off days-on worst days-he swats at people if cant' do what he wants." It was noted that transitions could be hard for him. His social skills were limited. He played with his brothers, but had on interest outside of his family. His father stated, "He does his own thing. He is fearless." The subject had received three courses of chelation therapy with DMSA and was noted to have had behavior problems secondary to it on 11/30/00. The pediatrician made a diagnosis of "speech disorder" and recommended speech therapy twice weekly for one year for a speech disorder and a comprehensive stool analysis. She wrote that she would prescribe 'meds if behavior worsens." She also referred the subject to anotehr physician. The most recent info was received on 9/16/02. As of 4/11/02, the pervasive developmental disorder and autism were ongoing. The outcome of the mercury poisoning was unknown. *Follow-up report on 10/10/2002: On 11/6/01, the child began occupational therapy twice weekly for myofescial release and craniosacral therapy. On 4/11/02, after approximately 5 mts of therapy, the physical therapist wrote, "Currently he has trouble dressing himself and continues to require help. He is potty trained for urine (although has a tendency to urinate in unwanted places). He is still not trained for bowel movements. He is able to feed himself but is unable to cut his food or organize himself for school. He has a 2 y.o. brother and will play alongside him, although tends to be overly aggressive at times. At school he requires an adult to always be present.... ASSESSMENT AND RECOMMENDATIONS: [The child] is an active, busy little boy who appears to be significantly struggling in his 2ndary motor development and modulation of sensory input. This will contribute to difficulties interpreting sensory stimuli, motor planning and skill development. These all lead to behavioral issues. He is currently showing significant deficits w/in his foundation and coordination areas. These include low endurance and tone, poor tactile discrimination, modulation issues and fine motor/ perceptual difficulties. These issues are all related to his vestibular and propriceptive systems. His motor development roughly demonstrates scattered abilities more typical of a 2 to 3 y.o, as compared to his 5 and a half year chronological age. While he initially appeard to be quite capable motorically, his impulsivity and lack of safety awareness presents a significant risk to him. Sensory Integration therapy has been found to be beneficial in promoting adequate foundstion skills and abilities, paving the way for higher function. This is not a quick fix therapy and will likely take several yrs to create the pathways necessary for more organized function. I would recomment a minimum of 2 physical/occupational therapy sessions per wk. At the end of a 6-8 mt period we will re-assess him to determine how quickly things are coming together for him.. We have found that progress is maximized when a combination of craniosacral and sensory integration techniques are used." The most recent info. was received on 7/16/02. As of 4/21/02, the pervasive development disorder and autiasm were ongoing. The outcome of mercury poisoning was unknown. Y Y N 03/10/1997 Immittance testing was done to evaluate middle ear function and the right revealed a flat tympanogram, consistent with effusion, but since his positioning was poor and he was moving and crying there is a large margin for error. On 2/9/00, communication evaluation; "Currently, his overall language ability is an average of 22 months below his age level, placing him in the 17 to 21 month old range..prognosis for improvement with therapeutic intervention is good." Gilliam autism rating scale on 3/1/00-77 (Low risk category for autism). Hair analysis 5/23/00-elevated levels of aluminum, mercury, copper, zinc, selenium and sulfur. 5/24/00-BUN/creatinine ratio, serum iron, hemoglobin, hematocrit and eosinophil-elevated; IgA, IgE, IgG-allergies (many). Fragile X, DNA probe-negative, laoleucine-58 umol/L; leucine-106 umol/L; tryptophan plasma-38 umol/L; tyrosine plasma-56 umol/L; valine-36 umol/L; MRI brain-normal brain pattern; overnight EEG-abnormal videoelectroencephalography monitoring demonstrating spikes and sharp waves from the right frontocentral region which demonstrates epileptiform activity. Platelet count, blood 15,000 OTH OTH PPD Tine test (Tuberculin purified on 6/6/97 and 9/23/97; albuterol; Amoxil; Xopenex; Zyrtec UNK Acute pharyngitis; allergic reaction NOS; allergic rhinitis; allergy to albuterol; blood in urine; blood spots in diaper; bronchiolitis; bronchitis; chronic cough; conjunctivitis; diarrhea; nasal congestion; nursemaid's elbow; otitis media; pneumonia; possible coxsackle virus; rash; RAD; sinusitis; swimmer's ear; tonsillitis; URI and a family history of language delay in the pt's cousin, in which he did not start speaking until he was 4 years old. F/U states allergies to dust mites, egg whites, Cladosporium herbarum, Candida albicans, Alternakia alternata/tenuis, soybean, papaya, brewer-s yeast, cow's milk, wheat and corn; asthma; Hospital records indicate that rupture of the membranes occurred 25 minutes following the mother's admission. However, she "complain of 'leaky' all week. The child's mother reported that three cousins had unspecified "speech problems," one cousin had attention deficit disorder and one aunt had an unspecified mental illness. 20010164111 1
0173290 07/17/2001 M 07/13/2001 Information has been received on 07/09/2001 from an attorney concerning a male pt. Medical history was not provided. The pt received 3 polio vaccines taken orally between 1959 and 1960. The pt since has developed pleural mesothelioma. This event was considered serious due to the development of cancer. U 01/01/1960 UNK OTH OTH UNK UNK UNK 3130411 1
0173291 07/17/2001 PA 1.5 1 .8 F 07/13/2001 A mother reported, via a company representative, that her 18 month old daughter received a 2nd dose of Prevnar vaccine (date unknown). The child has a past history of pneumonia, ear infection, bronchospasm and cough following her 1st dose of Prevnar vaccine in 11/00. See case ID HQ3082310JUL2001. One day later, the child developed fever and swelling. Three days later, the child developed wheezing and was taken to the ER. At the ER, she developed labored breathing, appealed pale and was dx'd with bronchiolitis. The child received "breathing" and steroid treatments and was discharged to home with an inhaler. This case was considered serious since bronchiolitis was considered to be "Medically Important" in this case. No additional information was available as of the date of this report. F/U information received 7/30/01; Prevnar and Hib-Titer vaccines received on 4/25/01. Concomitant medication included amoxicillin clavulanate (Augmentin). Lab data includes CXR that revealed no active lung disease. The child recovered. Follow-up info received on 7/27/01, stated that child had several ER visits (unidentified) following Prevnar immunization. Additional information received 9/7/01. Four days, post vax of 2nd Prevnar immunization, child started vomiting. She vomited 5 times before being seen in the ER. In 7/01, the child was given a dx of asthma. Y Y 04/25/2001 04/29/2001 4 CXR-nml PVT OTH Amoxil; Augmentin; Control for Amoxicillin; Clavulanate NONE Bronchospasm NOS; Cough; Ear infection NOS; Pneumonia NOS Pneumonia, bronchospasm, cough and ear infection~Pneumo (Prevnar)~1~0.00~In Patient|~Pneumo (Prevnar)~1~0.00~In Sibling HQ3176412JUL2001 1
0173309 07/17/2001 MA 37.0 37 M 06/27/2001 On 4/12/01, I received the 3rd in a series of 3 Lymerix vaccinations. 2 1/2 days, post vax, I had flu-like symptoms. One week later, I had extensive pain in my left foot, ankle and bottom of foot. The joints stiffened up in my feet, wrists, fingers and knees. Since 4/12/01, I have been to 7 doctors with no direct answer to my condition. I am still in pain and I can barely walk some days. I am presently taking 3200mg of ibuprofen and using doxycycline. Y Y N 04/12/2001 04/12/2001 0 Numerous blood tests UNK UNK NONE 1
0173310 07/17/2001 MI 1.0 1 .1 F 06/29/2001 Father states the patient ran a low fever on 06/26/2001 and on 06/28/2001 the patient had a "seizure like" episode. The patient stopped breathing and was transported via ambulance to the ER. Y Y 06/25/2001 06/28/2001 3 PUB PUB NONE NONE NONE MI2001052 1
0173311 07/17/2001 MI 3.0 3 F 06/26/2001 Post-vax the patient had swelling of the right leg from the ankle to the thigh and also a red rash over the entire right leg. The patient had soreness of the right thigh and was treated with Tylenol. Y Y 06/25/2001 06/26/2001 1 PUB UNK NONE NONE NONE MI2001051 1
0173312 07/17/2001 TN 0.7 0 .7 F 06/25/2001 The patient woke up at 4:00 am on 06/19/2001 and had a seizure. The patient's fever was 101.4F. The mother of the patient states the seizure lasted 5 minutes. The patient was treated at the ER with Advil and received a prescription for Amoxicillin to treat an ear infection. The patient was referred to a neurologist. Y Y 06/18/2001 06/19/2001 1 Chest X-ray, blood work PUB UNK NONE NONE TN01027 1
0173313 07/17/2001 TN 1.5 1 .6 M 06/27/2001 24 hours post-vax the patient experienced swelling of the right thigh. Y U 06/25/2001 06/26/2001 1 PVT UNK TN01029 1
0173314 07/17/2001 TN 0.75 0 .5 M 06/29/2001 Approximately 2 hours post-vax the patient's cheeks began turning red and swelling. The mother states the patient became limp and "felt hot". The mother treated with Tylenol. The patient was diagnosed at the ER as having had an allergic reaction to the immunization. The patient was treated with Benadryl and was better the next morning. Y Y 04/10/2001 04/10/2001 0 PUB PUB NONE Diarrhea TN01028 1
0173315 07/17/2001 TN 1.25 1 .3 M 07/10/2001 The patient has experienced constant crying, sometimes with a high pitched scream, since vaccinations were given. The patient has a fever "by touch" on and off. Y U 07/05/2001 07/05/2001 0 CBC-wnl, PE-otherwise OK PVT PVT Advil NONE NONE 1
0173316 07/17/2001 CA 1.9 1 1 F 07/06/2001 Patient experienced swelling and redness of the left lateral aspect of the thigh. Y 07/05/2001 07/06/2001 1 NONE PVT PUB Fever x 2 days, 101-102F 1
0173317 07/17/2001 IN 4.0 4 F 07/09/2001 The patient's immunization was administered in the AM. That afternoon the patient woke from a nap with a fever of 103F and leg pain. All symptoms were resolved by the following AM. Y 07/05/2001 07/05/2001 0 NONE PVT PVT NONE NONE NONE 1
0173318 07/17/2001 PA 2.0 2 .0 F 07/09/2001 Patient experienced weakness, sweating, crankiness, vomiting, fever of 102.2F, and could not walk. The patient wakes up crying and has a changed personality. The patient's heart was racing and her stools were discolored. The patient was treated with Tylenol and Motrin. Y 08/03/2000 08/04/2000 1 NONE PVT PVT NONE Pfeiffers Syndrome 1
0173319 07/17/2001 MD 55.0 55 M 06/12/2001 The patient experienced severe pain in the shoulder and neck area with numbness and tingling down to the fingers in the right hand. This progressed over 2 years to pain in the right elbow. Tingling and numbness was experienced in both hands and fingers. At initial onset the patient was treated with pain medication and referred to a chiropractor. The patient continued with periodic episodes of pain and was later diagnosed with rheumatoid arthritis. Y N 08/05/1999 09/16/1999 42 X-rays, MRI, Bone Scan, ESR, Westergren, RA factor, Lyme AB IGG, Western Blot, Lyme Antibody IGM, Western BL, B burgdorfen, Ab screen, hepatitis, antinuclear Ab titer, HLA-B27 Antigen PVT OTH NONE NONE NONE 1
0173320 07/17/2001 OH 47.0 47 F 07/11/2001 Approximately 24 hours after receiving an anthrax injection, the patient developed an itchy, red, raised area approximately the size of a 50 cent piece, at the injection site. Y 07/09/2001 07/10/2001 1 NONE OTH MIL BCP-Lo-Ovral NONE NONE 1
0173321 07/17/2001 OK 1.08 1 .1 F Within 4-5 hours after receiving Prevnar vax, the patient developed a rash everywhere except her face. There were no other symptoms. The patient was treated with Benadryl. Y 04/09/2001 04/09/2001 0 PUB UNK URI and teething NONE 1
0173322 07/17/2001 MI 15.0 15 F 06/26/2001 Patient complained of her right shoulder aching on 06/22/2001 and her left should aching on 06/23/2001. Patient also complained of her hip aching. Dr does not think these symptoms are vaccine related. Blood work was done, but there are no results yet. Y U 06/17/2001 06/22/2001 5 PUB UNK NONE NONE NONE MI2001050 1
0173323 07/17/2001 MI 0.25 0 .2 M 06/20/2001 Post-vax the patient developed a low grade fever and screamed non-stop day and night for 3 days. Sometimes the scream was high pitched. He would stiffen his arms and legs, shake his arms and turn red in the face. There was slight redness at the injection site, and no swelling. The patient was initially fussy right after the injections. Y 06/04/2001 06/04/2001 0 NONE PUB PUB NONE NONE NONE MI2001049 1
0173324 07/17/2001 VA 4.0 4 M 06/07/2001 The patient complained of post-vax redness and swelling of his arm. Y Y 06/05/2001 06/05/2001 0 NONE PUB PUB NONE NONE NONE VA01021 1
0173325 07/17/2001 VA 24.0 24 F 07/11/2001 One hour post-vax the patient returned to the clinic complaining of her left arm itching. The injection site was reddened 30mm in diameter. The patient was treated with Benadryl. Y 07/11/2001 07/11/2001 0 PUB PUB NONE NONE 1
0173326 07/17/2001 AL 4.0 4 F 07/09/2001 The patient had a small seizure. Y Y 08/28/2000 08/28/2000 0 PVT PVT NONE NONE NONE 1
0173327 07/17/2001 SC 0.2 0 .2 M 05/14/2001 Three days post-vax the patient began crying 2-3 hours and could not be consoled. A fine nonpuritic rash developed on his chest, mouth and legs at the injection sites. The patient has been vomiting large amounts of formula for 4-5 days. Mother denies fever and antibiotic therapy recently. Y 10/11/2000 10/14/2000 3 PUB PUB Decongestant; Milecon drops;Coldec Upper Resp Congestion with increased flatus. NONE SC0093 1
0173328 07/17/2001 OH U Two days post-vax the patient developed many red, itchy papules on the left upper arm. Y U PVT UNK 1
0173329 07/17/2001 WI 1.25 1 .3 M 07/11/2001 The patient's thigh was warm and red in a 9x7 cm area. The patient was treated with Cephalexin. Y Y 07/03/2001 07/05/2001 2 NONE PVT PVT NONE NONE NONE 1
0173330 07/17/2001 WV 4.0 4 F 07/10/2001 The patient developed a rash 07/05/2001. There were 15 lesions which started as clear vesicles and then became crusty. Y 08/17/1999 07/05/2001 688 PVT PVT 1
0173331 07/17/2001 OH 10.0 10 F The patient developed an itchy rash to the face approximately 10-15 minutes after the immunizations were administered. The patient was treated with Benadryl. Y Y 06/28/2001 06/28/2001 0 OTH UNK NONE URI, pharyngitis, acute allergy to cats, allergic rhinitis, and allergic conjunctivitis 1
0173332 07/17/2001 0.7 0 .6 F 07/10/2001 Localized indurated allergic reaction. U 07/09/2001 07/09/2001 0 UNK UNK 1
0173350 07/18/2001 IL 37.0 F 07/12/2001 Information has been received from a 37 year old female consumer who in 1993 was vaccinated 3 times with Hep-B vaccine recombinant (yeast) 10 mcg IM. In 2001, during pre-op testing for a cholecystectomy, lab blood work revealed that the pt was A, B, C, negative and her liver enzymes were elevated. The physician re-ran the liver enzyme test and it was normal. On 6/8/01, the pt underwent a cholecystectomy and during the procedure a liver biopsy was performed and revealed chronic hepatitis grade 2 and an inflammed liver. The pt reported that her medical history was such that she could only assume that her experience was from the vaccination. Upon internal review, the hepatitis was considered to be an "Other Important Medical Event". Additional information has been requested. F/U from the pt's physician it was reported that the pt did not have an adverse event after vaccination and that she did not have chronic hepatitis. No further info is available. F/U info from a woman in the physician's office noted that the pt's records indicated that she was not on any medications. The woman stated that she did recall that the pt was extremely anxious. No further info is available. F/U from a physician noted that this case was "an absolute non-issue". He stated that the pt did not have liver disease and there was no relation to her liver tests results and the vaccine. The physician stated that the pt had a gallstone problem. No further information is available. This report no longer meets the criteria for expedited submission because the serious event of hepatitis was removed as an adverse event. U 01/01/1993 06/08/2001 3080 Lab tests-A,B,C neg; liver biopsy-chronic hepatitis grade 2 and liver inflammed and liver function tests were elevated; lab tests were reran and were nml. OTH OTH NONE Cholecystectomy gallbladder disorder (cholecystectomy) WAES01062641 1
0173356 07/18/2001 LA 2.0 2 .0 F 06/15/2001 Child received immunizations on 4/3/01 and approx. 6-8 weeks, post vax, she began bruising and developed bleeding in right eye. She was seen in ER on 5/29/01. Platelet count was 5000 and she was transferred to another facility for follow-up. Per doc 208368, 60 day follow up; regional nurse spoke with patient's grand mother on 02/13//2002.Once a month, platelet count continues to be monitored. Expect monthly blood drawn for the next five months. Platelet count stable at this time. Diagnosed with ITP. Y Y 04/03/2001 05/15/2001 42 Platelet count-5000 (decreased) PUB PUB NONE ASD/Open heart surgery LA010702 1
0173357 07/18/2001 PA 0.9 0 .2 F Pt is a 11 month old female who received vaccinations on 9/19/00. Child had severe GER and Laryngomalacia at that time and was on Zantac and Reglan. 4 weeks later, she developed spastic muscle movements. Reglan was decreased and she continued to have spasms and then was dx'd with infantile spasms. The 60 day follow-up states infantile spasm. Y U 09/19/2000 10/16/2000 27 EEG-consistent with infantile spasms PVT UNK Reglan and Zantac Gastroesophageal Reflux and Laryngomalacia 1
0173358 07/18/2001 NM 1.0 1 .0 F 07/05/2001 Febrile illness with seizures, respiratory insufficiency with assisted ventilation. Dx: Metabolic Acidosis. Y Y Y 5 Y 06/21/2001 06/25/2001 4 CT Scan of Brain; CBC-nml; Bicarbonate 14 PUB PUB NONE NONE Hyperbilirubinemia as newborn. 1
0173359 07/18/2001 WA 1.6 1 .6 M 07/10/2001 Developmental regression evident within 5 to 6 months, loss of gross and small motor suspected at 8 weeks, loss of speech and social connection, loss of appetite, diarrhea and cyclic vomiting, severe sensory issues, purposeless and hyperactive behavior. Pt had 1st MMR/MSD/1161W/LL on 11/1/94 as well as a 2nd OPV/Lederle/PO on the same date. The 60 day follow-up states language loss/disorder; neurological issure-sensory, motor; social/emotional delays; developmental delays; learning disabilities; attention/hyperactive issues. Follow up information received on 09/18/2002 states " Cognitive delays/ learning difficulties, sensory issues, speech/language-communication disorder, auditory processing problems, fine & gross motor delays, social & emotional difficulties". The annual follow-up states "cognitive delays/learning disabilities, sensory issues, speech/language-communication disorder, auditory processing problems, fine and gross motor delays, social and emotional difficulties." Y N 01/19/1995 05/01/1995 102 Lab test revealed high levels of mercury PVT PVT NONE NONE NKA bronchial asthma~DTP (no brand name)~~0.00~In Patient 1
0173374 07/18/2001 CT 0.75 0 .8 M 07/12/2001 Pt received Prevnar #1 on 1/5/01 and mother noticed urticarial, erythematous, maculo-papular rash all over body, including face, the next morning, post vax. No other triggering factor noted except that the pt wore a new pajama set that night. Rx'd with Benadryl and hydrocortisone cream. Y 01/05/2001 01/06/2001 1 NONE PVT OTH ? DM for cough URI Sickle Cell Trait 1
0173375 07/18/2001 PA 0.3 0 .4 M 07/17/2001 Both legs became sore the day of vaccination on 3/29/01 and child developed a temperature of 101.9F. Both the fever and sore legs were better on the 3rd day. Y 03/29/2001 03/29/2001 0 PVT UNK Eczema 1
0173377 07/18/2001 NY 0.5 0 .5 M 06/20/2001 On 6/19/01, child woke up from sleep with fever of 104F, crying and cranky. U 06/18/2001 06/19/2001 1 NONE PVT PVT Tylenol, Advil NONE NONE 1
0173378 07/18/2001 MS 0.3 0 .4 M 07/11/2001 Fever and crying started around 20:00 and mom and grandmother states that pt was very hot to the touch. Had no thermometer to check temperature. Has vomited his formula X 3. Has been giving him Tylenol. Referred to pt's pediatrician. Not recovered at the present time. Y N 07/10/2001 07/10/2001 0 NONE PUB PUB NONE NONE NONE 1
0173379 07/18/2001 NJ 0.6 0 .6 F Five days post vax, pt developed blue spells and was admitted. She underwent a full sepsis work-up, cardiac work-up and all were normal. It was possibly a vaccine related reaction. Y Y Y 06/27/2001 07/02/2001 5 CBC; BC; UA; U Cx's; CSF; Cx's; Chem; EEG monitor PVT PUB NONE unilateral hydronephrosis 1
0173380 07/18/2001 IN 1.48 1 .5 M 07/09/2001 Mother stated that MD stated that pt had the "worst case of vaccine-induced chicken pox he had ever seen." Pt treated with Pedialyte, Aveeno bath and Tylenol. MD told reporter that he didn't think VAE report was necessary. Pt had 7 new pox the day of report. Y 06/29/2001 07/05/2001 6 NONE PUB PUB NONE NONE NONE 1
0173381 07/18/2001 MI 1.5 1 .5 F 06/29/2001 Pt developed a 3 x 5 cm circumscribed, annular erythema and swelling. Y 06/28/2001 06/29/2001 1 PVT UNK 1
0173382 07/18/2001 CA 0.5 0 .4 M 07/11/2001 Pt developed high fever (106.4) and lethargy. Pt was seen and monitored in the ER and was sent home after Motrin and Tylenol was given. Y Y 05/17/2001 05/17/2001 0 MIL MIL NONE NONE 1
0173383 07/18/2001 OH 4.0 4 M On right arm, pt developed a reddened, warm to touch, bruised area 10 x 10 cm. On left arm, pt developed a less reddened, warm to touch 4 x 3.5 cm area. There were no complaints of tenderness or pain. Follow-up showed less warmth and general size or erythema improved. Y Y 07/10/2001 07/11/2001 1 PVT PUB NONE NONE Asthma 1
0173384 07/18/2001 MA 1.0 1 .0 M 07/12/2001 Pt woke with varicella appearing rash less than 24 hours after receiving vaccine. Torso and back were covered and had some on arms and legs. No known exposure to varicella. Y Y 07/11/2001 07/12/2001 1 PVT PUB NONE Status post pyloric stenosis; milk protein allergy 1
0173385 07/18/2001 NH 1.0 1 .0 F 07/10/2001 Pt developed swollen left lateral thigh with localized heat, induration and redness about 3-4". It was not painful. Y 07/09/2001 07/10/2001 1 PVT PUB NONE NONE Questionable egg allergy 1
0173386 07/18/2001 UT 1.0 1 .0 M 07/10/2001 Pt developed fever of 100-102 2 days post vax. Three days post vax, fever was 103, and parents took pt to ER where he was treated with Ibuprofen and Benadryl. Pt taken to MD the next day and fever improved that day. One mo later, pt developed a rash over torso, legs and neck, described as red and raised. The duration was 3-4 days and he had a fever of 101. Y Y 05/08/2001 05/10/2001 2 NONE PUB PUB Tylenol Cold symptoms, teething NONE 1
0173387 07/18/2001 CA 1.25 1 .3 M 06/14/2001 Pt had a high fever of 103.3 on 6/14/01 at 05:30. Pt given Motrin and fever 101.3. At MD office, temp was 102.4. Treatment is symptomatic care. Y Y 06/12/2001 06/13/2001 1 PVT PVT 1
0173388 07/18/2001 CA 26.0 26 F 07/11/2001 Urticaria/hives, itchy rash over much of body. Right arm paresthesias. Had a TD vaccination on 7/25/00. Y 07/03/2001 07/09/2001 6 NONE MIL MIL PPD/Connaught/C0824AA/ID/LFA/2 previous doses; oral contraceptive NONE NONE 1
0173389 07/18/2001 U Pt suffered extreme weakness, body aches, film in front of eyes. Y 06/01/2001 06/07/2001 6 NONE PVT PVT NONE Chronic sinusitis, Sjogren's syndrome, thyroidectomy, dermatology problems, allergic to PCN and sulfa drugs, and osteoarthritis. Hx of false positive on second dose of tuberculin PPD at age 45. 1
0173390 07/18/2001 TX 22.0 22 F 07/06/2001 Pt called 1 hour post-injection c/o scratchy throat and chest pain. Pt instructed to call 911. Will follow up tomorrow. Y Y 07/05/2001 07/05/2001 0 PUB PVT 1
0173391 07/18/2001 NY 1.7 1 .7 F 07/11/2001 The patient's parent report on 05/03/2001 that the child was limp, had poor tone and cried a lot. On 05/04/2001 the patient had a CT scan and blood work. Results for both were negative. On 05/07/2001 the patient started stuttering and refused to talk. On 05/10/2001 the patient was seen by a neurologist and the exam was negative. On 07/11/2001 the patient was almost back to normal. Y Y 05/02/2001 05/03/2001 1 PVT OTH NONE Vaginal adhesions, dysuria NONE 1
0173392 07/18/2001 PA 34.0 34 F 07/11/2001 The patient experienced a fever of 101.9F, joint pains, chills, dizziness, chest tightness, a headache, and body pain. The patient was treated with Motrin and Rocephin. Y Y 06/28/2001 07/01/2001 3 C&S, Chemistry Profile performed - results unknown PVT PVT NONE NONE NONE 1
0173393 07/18/2001 GA 50.0 52 F 07/12/2000 24 hours post-vax the patient developed extreme pain, redness, swelling and a fever in her arm. The area of redness and swelling expanded to 3 inches in diameter and became very hard. ER doctor diagnosis is cellulitis. The patient also has the same type of swelling with extreme sensitivity on her upper thigh. The patient was treated with ibuprofen and Cephalexin. The patient still has pain and black and blue marks on her arm with a lump underneath. The patient still has excessive muscle pains and is now being treated with Motrin. Y N 05/24/2000 05/25/2000 1 PUB UNK NONE NONE NONE 1
0173394 07/18/2001 WI 0.3 F 07/09/2001 While on Tylenol, the patient experienced a fever of 102F within two hours of receiving vax. The patient developed lethargy, redness at the injection site, labored breathing, stiffening of the body, staring an average of 15 minutes and a blue tinge to the lips and around the eyes. The patient was taken to the hospital and to an MD and there was no diagnosis made. After 6 weeks, the patient was taken to a chiropractor who states the patient's body shut down and this could be due to the vax. Y U Blood tests, x-rays, urine test - all wnl. UNK UNK NONE NONE NONE 1
0173395 07/18/2001 MA 1.0 1 .0 M 07/12/2001 On 07/09/2001 the patient developed a rash with scattered erythematous papules on the abdomen with 1 early vesicle. U 06/26/2001 07/09/2001 13 PVT PUB NONE NONE 1
0173396 07/18/2001 OR 39.0 39 F 07/11/2001 8 days post-vax the patient experienced a fever for 3 days, a generalized rash and body and joint aches. Y 06/26/2001 07/04/2001 8 PVT PVT NONE NONE NONE 1
0173397 07/18/2001 TX 35.0 35 F 07/12/2001 The patient's arm was stiff and sore when waking in the AM. The stiffness somewhat decreased but the pain increased and radiated to the axilla, elbow and shoulder. Y 07/10/2001 07/12/2001 2 NONE PUB PUB Oral Contraceptive Pills Headache Fibromyalgia, allergic to sulfa drugs 1
0173398 07/18/2001 TN 1.25 1 .3 M 07/12/2001 The patient developed a red, papular rash on his check and experienced a rectal fever of 102.5F. U 07/05/2001 07/11/2001 6 PVT UNK NONE NONE 1
0173399 07/18/2001 ME 0.3 0 .4 M 07/11/2001 The patient experienced red splotches which started at the administration site, spread up his trunk and covered his left arm. The patient developed a fever of 102.5F which went away the next day. Y 05/10/2001 05/10/2001 0 PVT OTH NONE NONE 1
0173400 07/18/2001 MA 71.0 71 F 06/06/2001 By 3:00 pm post-vax, the patient was having a heavy heartbeat which lasted several hours. By 5:00 pm, the patient was not feeling well. She felt extremely warm, slightly nauseous, her heart hurt, her arm ached, and the right side of her throat felt swollen. These symptoms lasted about 30 minutes. The patient then had chills. The following day the patient felt tired and weak. Y 01/17/2001 01/17/2001 0 NONE PVT OTH Vitamins, Lorazepam, Phosphate Fluoride Rinse NONE NONE 10/95~Influenza (Seasonal) (no brand name)~1~66.00~In Patient 1
0173401 07/18/2001 CA 58.0 58 F 07/09/2001 3 days post-vax the patient developed a red and sore arm, anorexia, chills, a possible fever, fatigue and a headache. The patient had these symptoms 4-5 days. The patient's headache was severe enough to use medication every 2-4 hours. Y 06/27/2001 06/30/2001 3 NONE PUB PUB Glucophage; Immune Globulin NONE Diabetes 1
0173402 07/18/2001 PA 38.0 38 F 07/09/2001 The patient's left arm is swollen and painful. There is raised irritation. The axial lymph nodes are swollen the size of an egg. There is numbness, tingling and a loss of movement and strength in the left arm and hand. There is ongoing pain in the lymph nodes and breast discomfort. There is some improvement, but not all symptoms are gone. The site of the injection is still visible on the upper left arm. Y N 04/02/2001 04/03/2001 1 PVT UNK NONE NONE Celiac Disease 1
0173403 07/18/2001 OK 0.6 0 .6 M 06/20/2001 Approximately 1 hour post-vax the patient developed a fever of 103F with unconsolable crying for many hours. Y Y 06/04/2001 06/04/2001 0 PUB PUB NONE NONE OK0130 1
0173404 07/18/2001 MS 1.3 1 .3 F 07/10/2001 Pt received vaccinations on 6/26/01 and mother called office on 7/9/01, stating pt developed head to toe purpura rash on 7/8/01 and increased fever and neck swelled. Pt to local MD and was put on antibiotics. Rash to hands and soles of feet. Very concerned regarding child having "measles". Talked to Immunization supervisor. I talked to someone else at another facility and they advised pt to be checked for Rocky MT Spotted Fever. Mother took child to MD on 7/10/01 and he felt was a reaction to injections. Child was fever-free on 7/11/01 but still has rash. Child was sensitive to light. Y Y 06/26/2001 07/05/2001 9 PUB PUB NONE NONE Downs Syndrome MS01032 1
0173405 07/18/2001 MS 38.0 38 F 07/12/2001 Pt received MMR on 6/12/01 and on 6/18/01, in the AM, started having pain behind and inside of left ear, pain moved to left side of head and around left eye. Ice packs placed on eye. Pt awoke the next AM with chest pains and went to ER. She was placed on heart monitor. Pt states that PMD told her that he could not find anything wrong and that it may have been caused by reaction to MMR. Pt also stated that right arm was very swollen. She was treated with Tylenol 3. Y Y 06/12/2001 06/18/2001 6 PUB PUB MS01031 1
0173406 07/18/2001 PA 5.0 5 F 07/12/2001 High fever of 103.2F and a seizure. Y Y 06/05/2001 06/06/2001 1 PVT UNK Zyrtec On-going treatment for hives UNK 1
0173407 07/18/2001 WI 39.0 39 F 07/12/2001 Fever of 101F (oral), redness at site of injection with swelling and pain at injection site, also. Y 07/11/2001 07/11/2001 0 PVT PVT NONE NONE S/P splenectomy after bicycle accident 1
0173408 07/18/2001 CA 5.0 5 F 07/06/2001 Injection site red and swollen; developed cellulitis vs aseptic abscess; antibiotic was prescribed to pt for 2 courses. U 06/22/2001 06/23/2001 1 PVT PVT NONE NONE 1
0173409 07/18/2001 TX 50.0 50 F 06/28/2001 Increased redness and pain to injection. Instructed pt to apply ice and to take Tylenol for pain. Y 06/13/2001 06/14/2001 1 NONE PVT UNK Red arm NONE 1
0173410 07/18/2001 WA 5.0 5 F 06/27/2001 Swelling at injection site 13cm X 12.5cm. Treat with cool compresses and Benadryl po. Y U 06/18/2001 06/19/2001 1 PVT UNK NONE 1
0173411 07/18/2001 CT 8.0 8 M 07/10/2001 Hives, 5 minutes after shots. Benadryl 50mg po STAT. Y 07/06/2001 07/06/2001 0 PVT PVT NONE NONE 1
0173412 07/18/2001 TX 4.0 4 F 07/17/2001 Hepatitis A. U 05/30/2001 06/30/2001 31 Hepatitis panel revealing positive Hep-A. PUB UNK 1
0173413 07/18/2001 NV 0.25 0 .1 M 07/12/2001 Only shot in right leg was IPV. Pt's leg had bleeding after injection. Two weeks later, he developed a 2cm X 1cm hypo-pigmentated lesion, similar to a scar. Not evaluated. About the same, 6 weeks later. U 05/03/2001 05/07/2001 4 NONE PVT PUB 1
0173414 07/18/2001 CA 73.0 72 F 07/13/2001 Severe local reaction with cellulitis at site with fever and myalgias. About 6 years ago, required antibiotics. Y U 01/01/1994 04/04/2001 2650 UNK UNK 1
0173415 07/18/2001 CO 7.0 7 F 07/12/2001 Child is 7 years old and got DTAP (Regional shortage of TD and child with multiple recent cuts at work site of parent's home which is under construction). Child with integrated Sensory Deficit, thus increased pain tolerance. Mom noted a large lesion at injection site while child in warm bath this AM, 48 hours, post vax. Child decreased historian, denies pruritus or significant pain. Red, raised non-pruritic warm lesion right lateral thigh 6.2cm X 3.2cm (6.2mm X 32mm). Parents lived in Africa when child was 3 years old and had a severe pertussis at age 3. 07/07/2001 07/10/2001 3 UNK UNK Pertussis~DTaP (no brand name)~~3.00~In Patient 1
0173416 07/18/2001 GA 1.0 1 .0 F 07/17/2001 Small red spot on left leg at injection site. Y Y 07/16/2001 07/17/2001 1 PVT PVT NONE NONE 1
0173417 07/18/2001 WV 1.7 1 .7 M 07/17/2001 Rash on arms and legs and face. Y Y 07/17/2001 07/17/2001 0 PUB UNK 1
0173418 07/18/2001 CA 63.0 63 M 07/06/2001 On 7/5/01 at 15:00, I received a phone call from patientl's wife, who is also an employee there. She told me that a "Neurologist, told us it was the Hep vaccine that caused the seizures. She told me to notify you that you should call the number on the bottom of the paper (drug insert) to report it." Most of my information has come from the wifel, not from the patient or the physician. Consequently, I am unable to verify actual events, facts, etc. I do hope that the following information that I am furnishing will be of assistance to you. U 06/20/2001 UNK OTH PUB UNK UNK UNK 1
0173422 07/19/2001 PA 0.8 0 .9 F 07/11/2001 Pt had fever of 104.2 and irritability about 3 hours post dose-lasted about 12 hours. Y 04/06/2001 04/06/2001 0 NONE PVT PVT NONE NONE NONE 1
0173423 07/19/2001 PA 0.3 0 .3 M 07/17/2001 Redness and swelling and induration approximately 4 cm circular area around vaccine site on right upper outer thigh. With tenderness and fever. It took approximately 1 month to resolve. Small are of discoloration and induration still present after 2 months. Y 05/23/2001 05/24/2001 1 NONE PVT PVT NONE NONE NONE 1
0173424 07/19/2001 NC 0.5 0 .6 M 06/27/2001 Infant had a fever of 101-102 within 6 hours after his vaccines. He screamed uncontrollably for 4-5 hrs. Fever did not respond to Tylenol but did decrease with Motrin. Mild erythema on right thigh. Eating and drinking ok. Y Y 06/26/2001 06/26/2001 0 None PVT PUB NONE NONE NONE NC01060 1
0173425 07/19/2001 IL 1.2 1 .3 M 07/13/2001 Pt had redness, swelling, warmth, on upper 1/3 of right thigh. On site rxn to DtaP with cellulitis. Ceclor liquid TID x 10 days. Warm compresses. To recheck in one week. N 07/11/2001 NONE PUB UNK NONE NONE NONE 1
0173426 07/19/2001 MA 1.0 1 .4 M 07/18/2001 Received vaccines on 06/25/01. presented with mom on 07/02/01 with vesicular rash left chest covered with varicella. Y 06/25/2001 07/02/2001 7 None PVT PUB NONE NONE NONE 1
0173427 07/19/2001 IA 0.3 0 .3 F 07/09/2001 On the day of vaccine, pt was difficult to wake up, lethargic with a fever of 101. On day 2, pt had shallow breathing and was lethergic, difficult to awaken with a fever of 101. Right leg had a large lump. Y Y 05/08/2001 05/08/2001 0 PUB UNK Zantac Otitis media, acid reflux ~DTP + Hib (no brand name)~1~0.30~In Sibling IA01008 1
0173428 07/19/2001 NC 1.0 1 .0 F 06/29/2001 9 days ago pt rec'd vaccines - now with red papular rash progressing 6/28-29. Also with fever 102 F x 2 days 6/27,28. Seen for recheck 7/21/01 with complete resolution of rash. Y 06/19/2001 06/28/2001 9 NONE PVT PUB fluoride drops, Cardec DM Cough, nasal drainage NONE NC01059 1
0173429 07/19/2001 PA 4.0 4 M 07/12/2001 Vomiting and temp 105F approximately 5 hrs post vaccine. Temp down to 102-103F on 7/11/01, symptoms lasted approximately 24 hrs. Y 07/10/2001 07/10/2001 0 NONE PVT PVT Zyrtex syrup NONE Allergy to dust and mold 1
0173430 07/19/2001 NY 12.0 12 M 07/18/2001 1 day post vaccine, knee pain, swelling, rash, vomiting. Serum sickness including urticaria, angioedema, malaise, vomiting, arthritis both knees. Rx Zyrtec, motrin. Y U 07/10/2001 07/11/2001 1 PVT PUB NONE NONE NONE 1
0173431 07/19/2001 UT 47.0 47 F 07/12/2001 Immediately after vax the patient experienced paleness and slight dizziness. Ten minutes later the patient felt like crying, a deep aching pain began to spread throughout her body and experienced an intense feeling of heaviness. 30 minutes post-vax the patient developed joint stiffness. 60 minutes post-vax the patient experienced difficulty breathing, a frantic feeling, nausea, and numbness in her hands. 90 minutes post-vax the patient experienced slight delirium and flailing arms. 2 and 1/2 hours post-vax she experienced a high fever and weakness. Treated with Vitamin C. Y 06/30/2001 06/30/2001 0 PUB PVT Vitamins and L Tyrosine NONE Allergies to molds, pollens, grasses, cherries, avocados, cod fish, fresh carrots, etc. 1
0173432 07/19/2001 SD 4.0 4 F 07/12/2001 On 07/11/2001 the patient's right arm is swollen and red. The child is afebrile. Y U 07/10/2001 07/11/2001 1 PUB OTH TB NONE NONE 1
0173433 07/19/2001 69.0 69 F 05/22/2001 Information has been received describing a 69 year old female with a history of osteoporosis and rheumatoid arthritis who received an influenza virus vaccine on 1/30/01, the same day that she also received her quarterly infusion of pamidronate. Concomitant therapy included Enbrel (etanercept), prednisone, omeprazole, atenolol, levothyroxine, aspirin and simvastatin. Two days later, on 2/01/01, she developed fever of 106F with joint pains. She was hospitalized and treated with amoxicillin clavulanic acid for 2 days. Therapy was discontinued when the possibility of an infection was ruled out by her physician. The pt recovered. The reporter noted that the treating rheumatologist considered the events to be temporally related to the pamidronate infusion or the influenza virus vaccine. See related Enbrel report HQ0850614MAY2001. Y Y 01/30/2001 02/01/2001 2 on 02/01/2001 body temperature for pt was 106 degrees F OTH OTH Bayer aspirin; Atenolol, Embrel, Levothyroxine, Omeprazole, Pamidronate Disodium, Prednisone,Simvastatin UNK Osteoporosis NOS; Rheumatoid arthritis HQ1063318MAY2001 1
0173434 07/19/2001 TX 65.0 65 M 06/01/2001 A wife reported that her 65 yr old husband received an injection of Flu Shield 2000-2001 formula in late November 2000. In January 2001, he developed facial paralysis, numbness, and dizziness. She indicated that her husband related these symptoms to the Flu-Shield. The reporter stated that her husband has recently been dx with a slight elevation in hypertension and was prescribed Atacand. Additional information received from the pt, a physician , on 05/21/2001 indicated that in addition to those symptoms reported by his wife, he is experiencing tremor, foggy memory, blurred vision, and a feeling of heaviness in his face, particularly around the orbital muscles. The pt has consulted with several physicians and stroke was ruled out. Y U 11/01/2000 01/01/2001 61 MRI results were atypical with white matter distant from the ventricles. OTH OTH Atacand UNK UNK 073611 1
0173435 07/19/2001 TX 39.0 39 F 07/12/2001 A pt who received a dose of Flu-Sheild on 12/20/2000 subsequently experienced pain in all her joints. She was seen by a physician and prescribed oral Prednisone. She indicated that she was allegedly dx with post traumatic arthritis 8 days post vaccination. As of 06/26/2001, she stated that pain persists her right ankle only. Follow-up received from the pt on 9/11/02, stated that a lymph node biopsy will be performed mid-September 2002, for possible sarcoidosis. U 12/20/2000 12/28/2000 8 unk OTH OTH none none unk HQ2620428JUN2001 1
0173436 07/19/2001 MT 44.0 43 F 05/25/2001 a 44 yr old female pt received an injection of Flu Shield 2000-2001 on 12/13/2000. Subsequent to a blood drive on 02/19/2001, her blood tested positive for hepatitis C and HTLV 1 & 2. The Red Cross told the reporter that a false positive reaction laboratory test interference nos with influenza vaccine was possible. The abnormal laboratory results were received on 03/15/2001. U 12/13/2000 02/19/2001 68 02/19/2001 antibody nos test abnormal. Blood tested positive for hepatitis C and HTLV 1 & 2. UNK UNK 1
0173437 07/19/2001 CT 28.0 28 F 05/08/2001 A physician reported that a 28 yr old female received an injection of Flu Shield on 12/26/2000. On 12/28/2000. she developed numbness in her left leg and treated with and pins and needles in her left foot. She was seen by the physician and treated with prednisone. She was later seen by a neurologist after her symptoms persisted and treated with more prednisone. She then developed tremors in both legs and received tx with Carbamazepine. Additional info received form the physician on 04/30/2001 indicated that her sx have slowly resolved. MRI imaging of her brain and spine were normal. Additional information have slow received on 04/03/2001 her sx have slowly resolved, but she only has numbness 0f the upper back. Y Y 12/16/2000 12/28/2000 12 MRI results Normal brain and spine images OTH OTH UNK UNK UNK HQ9404606APR2001 1
0173438 07/19/2001 NC 55.0 M 05/31/2001 Neuritis - A pharmacist reported that a 55 yo pt rec'd an injection of Flu Shield (2000-2001 Formula) vaccine and, within 48 hrs post vaccine,pt developed neuritis/neuropathy in his R arm. The condition lasted 4 wks and completely resolved. This report was received from Aventis Pasteur (U2001-004830). Y Y UNK PVT PVT UNK NONE UNK HQ0604407MAY2001 1
0173439 07/19/2001 IL M 06/06/2001 Injection site reaction - an adult pt rec'd an injection of Flu Shield (2000-2001 Formula) in Oct 2000, and developed soreness at the injection site. With a day or two, the injection site pain extended to his shoulder and to his elbow joint which became sore at full extension or under load. As of 5/17/01, he reported that the condition has stabilized and continues to the current time and affects both shoulders. The second shoulder is affected to a minor degree. No further information was available at the date of this report. U 10/01/2000 10/02/2000 1 UNK OTH OTH UNK UNK UNK HQ1562901JUN2001 1
0173440 07/19/2001 F 06/04/2001 Influenza - a consumer reported that recently her friend may have inadvertently rec'd a double dose of the influenza virus vaccine (2000-2001 Formula) and subsequently developed a bad case of the flu. The reporter declined to provide further information and declined to grant permission for follow-up investigation. U UNK OTH OTH UNK UNK UNK HQ9605112APR2001 1
0173454 07/20/2001 TX 2.0 1 1 F 06/22/2001 Mom stated that child was in a daze at the daycare with no appetite and began vomiting and became unconscious, after arriving home. Transported to ER via EMS. Tests done without significant findings per mom. Y Y 3 Y 06/08/2001 06/08/2001 0 UNK PUB PUB pseudoephedrine, ferrous sulfate Congestion NONE TX01092 1
0173455 07/20/2001 NJ 0.01 0 .0 F 07/03/2001 Rolling eyes, regurgitation of feeding, possible apnea episode. Admitted to hospital. Observation for 24 hour monitoring in hospital. Y 1 Y 07/02/2001 07/02/2001 0 Blood work PVT PVT NONE NONE 1
0173456 07/20/2001 MN 0.2 0 .3 F 07/11/2001 Pt crying, then quiet for about 2 minutes. Found by mom with blue arms and legs, pale face, not breathing. Gasped with vigorous stimulation, then had "shallow" breathing for several minutes. Y 2 Y 07/09/2001 07/09/2001 0 Negative chest x-ray, normal sleep study, UGI, Grade II & III reflux PVT PVT NONE NONE 1
0173458 07/20/2001 IL 3.0 3 M 07/13/2001 Erythematous skin, pruritus 10 cm diameter, non tender blanching - warm to touch - apply ice pack, benadryl , Keflex. Y 07/09/2001 07/10/2001 1 NONE PUB PUB NONE NONE NONE 1
0173459 07/20/2001 TX 1.32 1 .3 F 06/28/2001 6/28/01 - spots on face & back also gums today - white spots on gums. Will not eat solid since yesterday, will take juice. Had fever 101.2F since Monday, tonsil look red, raw meat. Referred to Dr. 6/29/01 reaction to chickenpox per Dr. Y 06/21/2001 06/25/2001 4 . PUB UNK NONE NONE NONE TX01087 1
0173460 07/20/2001 VA 0.3 0 .3 F 07/06/2001 Fever >105.0F in am 7/6/01 (within 24 hrs of vaccine, fussy, but consolable. Y Y 07/05/2001 07/06/2001 1 NONE PUB OTH NONE NONE NONE 1
0173461 07/20/2001 GA 1.5 1 .6 F 07/19/2001 Fussy, tired, rapid heartbeat, induration at sight of injection, red & swollen on legs (at injection site) the swelling was over 2 inches, & fever - symptoms begin that day & continued on till early morning of the 16th, was taken to the ER 6/13/01 for her legs (the swelling). They said it could of been an allergic reaction to the shots or cellulitis. Show was given a prescription for Cephalexin and Children's benadryl. Her fever was 101.5F consistently til the morning of 06/16/01 tylenol helped some. Y Y 06/12/2001 06/12/2001 0 PVT OTH 1
0173462 07/20/2001 NC 3.0 3 M 07/11/2001 Extensive erythema over anterior R thigh, slight tender & warm. No fever, walking normally. U 07/09/2001 07/10/2001 1 PUB PUB NONE NONE NONE 1
0173463 07/20/2001 1.25 1 .3 M 07/11/2001 PCV-7 vaccine given in L thigh am of 7/9. Parents noted redness and swelling around vaccine site that evening. Child noted to have scratched area around injection site. Next day, L thigh redness & swelling increased with increased warmth and hardness. Oral antibiotics started 7/11/01. Y U 07/09/2001 07/09/2001 0 NONE MIL MIL NONE NONE NONE 1
0173464 07/20/2001 VA 2.6 2 .6 F 07/17/2001 Fever began 7/12/01 PM, highest temp around 101F, lasted approx 2 days, then developed rash spreading over entire body. Described rash as itching with wh? on 3rd day. Mom states child well until Prevnar given. Y 07/12/2001 07/12/2001 0 PUB PUB 1
0173465 07/20/2001 TX 0.4 0 .4 F 07/02/2001 Child seen 6/26/01 for well appt & given Prevnar vaccine. Mom states 2 hrs later child with swelling face and dark circles under eyes. Mom denies giving child any medication that day or introducing new foods, soaps, lotions, plants, animals, etc. Mom reported Rxn 6/29/01 Y 06/26/2001 06/26/2001 0 NONE PVT PVT Zantac 75/5 1/4 tsp BID, Artivate cream NONE GE reflux and eczema 1
0173466 07/20/2001 TX 1.25 1 .0 M 07/02/2001 The pt experienced a rash on body since 7/1/01. Advisedskin care by doctor. Y 06/11/2001 07/01/2001 20 NONE PVT PUB PPD / connaught NONE NONE TX01091 1
0173467 07/20/2001 PA 1.08 1 .1 F 07/09/2001 Pt developed fever of 104 and was in a hyporesponsive state. She was very lethargic and could not lift her head up. Y 01/11/2001 01/12/2001 1 PVT OTH NONE NONE NONE 1
0173468 07/20/2001 TX 1.75 1 .8 M 06/29/2001 The pt was diagnosed with acute cerebella ataxia. The pt woke with legs shaking, unable to move or walk and crying. The pt started vomiting but had dry heaves. The pt experienced a fever, sinus drainage, sinus infection, raspy voice, congestion for three days. Y U 04/23/2001 06/28/2001 66 PUB PUB IPV by connaught was also given on 4/23 NONE chronic ear infection TX01089 1
0173469 07/20/2001 KY 0.6 0 .6 F 07/16/2001 Pt developed fever 2 hrs post vax. Mom noticed a rash on face and chest that she thought was from bottle spilling. The next morning rash was very red with hives all over pt's body. Pt had fever and was irritable all day. She was treated with Benadryl and Tylenol. On 7/15/01, hives were gone and rash was less red, and pt had no fever. On 7/16/01, pt back to normal with only slight rash still noted. Y 07/13/2001 07/13/2001 0 PUB PUB NONE NONE NONE KY2001050 1
0173471 07/20/2001 IL 5.0 5 M Several pox lesions, chest, back, legs, face and genital area. Y 06/28/2001 07/15/2001 17 PVT PVT Mantoux/Connaught/C0153AB/ID/RFA/1 previously; HRT; Testosterone injection every 3 months Congenital absence of testicles 1
0173472 07/20/2001 MD 64.0 64 F 07/18/2001 Pt developed a 2.5" x 3" red, hot, swollen area at site of injection in left arm. Discoloration still faintly visible after 1 month. Pt treated with Cyrtex x qd x 5. Y 06/13/2001 06/13/2001 0 PVT UNK NONE 1
0173473 07/20/2001 FL 1.4 1 .4 F 07/01/2001 High fever, jerking, staring, rash and seizure. Y 05/01/2001 05/10/2001 9 PVT OTH NONE NONE NONE 1
0173474 07/20/2001 NC 5.0 5 F 07/16/2001 Approx. 2cm red, slightly tender to touch area on left upper leg. U 07/05/2001 07/11/2001 6 PVT PUB NONE NONE NONE 1
0173475 07/20/2001 TX 4.0 4 M 06/22/2001 Mother states on 6/20/01, child developed redness and swelling in left arm, extending from elbow to shoulder. Area warm to touch. Prior to this only a smaller area had been reddened. Child seen by NP who told mother an infection was present and ordered antibiotics (cephalosporin). Y Y 06/18/2001 06/20/2001 2 NONE PUB PUB UNK NONE TX01090 1
0173476 07/20/2001 TX 1.3 1 .3 M 06/15/2001 Swelling right leg with erythema and warmth. Y 06/13/2001 06/14/2001 1 NONE PVT OTH TX01088 1
0173477 07/20/2001 TX 4.0 4 M 06/19/2001 Right leg swollen with warmth on front and back. Swollen left leg with erythema on front and side of leg with rash. Y 06/18/2001 06/19/2001 1 PVT OTH NONE TX01086 1
0173478 07/20/2001 TX 11.0 11 F 07/16/2001 Approx. 5 minutes, post vax, pt fainted in the lobby with her father at her side. After a few seconds, pt opened her eyes and said "I'm all right". Applied cool compress to forehead and back of neck. Per father, pt did not hit her head. Pt walked with assistance to exam room, with dad at her side. Pt stayed in room for the next 20 minutes, under observation. Per pt, "feel fine". She left clinic with her father. Follow-up call made to pt's home. Spoke to father who stated that pt is doing fine. Stated that she ate after leaving the clinic with no problems. Y 07/16/2001 07/16/2001 0 PUB PVT NONE PCN allergy SA0106 1
0173479 07/20/2001 TX 1.7 1 .7 F 07/13/2001 Child received shots on 7/10/01 AM and noted swelling and redness to upper thigh. Warm, moist compress was applied at 21:00. Noted swelling and redness to outer and upper thigh in the AM. Warm and moist compress applied and 30 minutes, looked better. Then child out on visit with parents for several hours. Noted left thigh with a lot of swelling and redness to inner thigh, over and outer thigh at 17:00 on 7/11/01. Sent to ER for evaluation and had no treatment at ER. Y Y 07/10/2001 07/10/2001 0 NONE OTH OTH NONE NONE NONE SA0107 1
0173480 07/20/2001 KY 12.0 12 F 07/18/2001 On 7/3/01, area was red and swollen, post vax. Pt returned on 7/13/01 and presented with redness and "hardness" in area. Y Y 07/03/2001 07/03/2001 0 PUB PUB NONE KY2001051 1
0173481 07/20/2001 HI 0.9 1 .1 M 07/12/2001 Pt received MMR on 6/5/01 and developed acute measles on 6/11/01. 06/05/2001 06/11/2001 6 UNK UNK 1
0173482 07/20/2001 VA 10.0 10 M 07/12/2001 Phone call received by mother. Child has itching, redness and bumps around injection site. Reports the same thing happened with 1st Hep-B. Advised Benadryl and ice. Recommended she check with PMD prior to receiving 3rd dose. Y 07/09/2001 07/10/2001 1 PUB PUB NONE NONE NONE Itching, redness at injection site with rash~Hep B (Recombivax HB)~1~10.00~In Patient 1
0173483 07/20/2001 PA 47.0 46 F 07/18/2001 Vomiting, shakes/tremors, weakness, headache, numbness and extreme tiredness. U 07/16/2001 07/17/2001 1 PVT PVT Atenolol 25mg, (blood pressure med) Vomiting, shakes/tremors, weakness, headache, numbness and extreme tiredness~Hep B (no brand name)~~0.00~In Patient 1
0173484 07/20/2001 KY 40.0 40 F 07/03/2001 1st HB vaccine administered (deltoid) at about 15:15 on 6/28/01. On 6/29/01 at about 09:00, headache began and it advanced to a migraine associated with nausea. Hot and cold flashes began about 11:30 AM. Was very weak at 16:00 and continued until about 20:00. Was well by Monday. Y 06/28/2001 06/29/2001 1 PUB PVT NONE NONE NONE KY2001049 1
0173485 07/23/2001 0.3 0 .4 M 07/19/2001 Information has been recvd re: 4-month-old male who received his second dose of blinded study vaccine. The pt nursed at 4 AM on 7/5/01 and then fell asleep with his mother. He was found on his back at the edge of the bed at 10:25 AM and was cold and non-responsive. He was pronounced dead by the medical crew that answered the call. The cause of death was "probable" sudden infant death syndrome (SIDS). The investigator reported that SIDS (unexpected per the Investigator Brochure) was not related to study vaccine administration or concomitant vaccines. The medical monitor considered the event to be probably not related to the study vaccine. This case is being submitted as a 15-day expedited report as requested by the FDA. A 15-day follow up report received 4/19/2002 adds: Follow-up info was received on 11/28/2001. An autopsy revealed the cause of death to be Sudden Infant Death Syndrome. The coroner's findings revealed the same. Both the investigator and medical monitor did not consider the event to be related to study vaccine administration or concomitant vaccinations. NOTE: This case is being submitted as a 15-day follow-up, expedited report, as requested by the FDA. Y 07/05/2001 N 06/26/2001 07/05/2001 9 NONE UNK UNK UNK HQ3122311JUL2001 1
0173489 07/23/2001 1.0 1 .0 M 07/13/2001 Information has been received from a reporting nurse via called correspondence concerning a 12 month old male with an upper respiratory infection "for a few days" who on 6/11/01 at 10:30, was vaccinated SC in the left arm with a 1st dose of varicella virus vaccine live and a 3rd dose SC in the left thigh of poliovirus vaccine. On 6/12/01, at 13:30, the pt experienced a "faint episode" white pushing a toy. It was reported that the pt "looked wobbly", went limp, experienced a "breathless" color of lips, turned purple and his head went back. It was noted that there was no foaming at the mouth. The experience lasted for a few minutes and then the pt took a breath. It was noted that there were no tonic-clonic movements and that the pt recovered from this experience. It was reported that the pt now has right otitis media. "Faint episode" and "breathless" were considered to be "Other Important Medical Events". No further information is available. Y 06/11/2001 06/12/2001 1 OTH OTH Upper respiratory infection WAES01070704 1
0173490 07/23/2001 PA M 07/13/2001 Information has been received from a physician concerning a "young" male who on approx. 6/11/01, was vaccinated with a dose of varicella virus vaccine live. The pt was reported to be "now" in the hospital with an acute lymphocytic leukemia-type picture. It was reported that the pt had early cells in lymph line and was being worked up for acute lymphocytic leukemia. The pt was also reported to be thrombocytopenic. The physician reported he was not sure if the pt's problems were related to the vaccine. The pt was reported to be still in the hospital and was "being worked up for ALL". Additional information has been requested. The child did develop thrombocytopenia. The child did not have lymphocytic leukemia. Y Y N 06/11/2001 07/01/2001 20 Diagnostic lab on 7/2/01-early cells in lymph line OTH OTH UNK UNK WAES01070194 1
0173491 07/23/2001 PA 0.5 0 .5 F 07/19/2001 The patient was taken to the ER with a fever of 104.5F (rectal) and difficulty breathing. The patient was diagnosed with acute febrile reaction due to vaccines. The patient was treated with Tylenol. Y Y 07/09/2001 07/09/2001 0 Chest x-ray - Negative PVT OTH NONE 1
0173492 07/23/2001 MN 1.25 1 .3 F 07/19/2001 The patient developed localized hives at the injection site with redness and warmth. The patient was treated with ice compresses and Benadryl. Y 07/17/2001 07/17/2001 0 NONE PVT OTH NONE NONE 1
0173493 07/23/2001 OH 2.0 2 .0 M 07/16/2001 Within 30 minutes of receiving vax, the patient developed generalized urticaria. Y 07/05/2001 07/05/2001 0 PVT PVT Ear infection NONE 1
0173494 07/23/2001 GA 0.75 0 .7 M 07/15/2001 Patient was seen in the ER on 07/15/2001 due to being sleepy, limp and blue extremities. The patient could be wakened by shaking, but fell back to sleep quickly. The patient could not be awakened enough to eat breakfast but did take 12 oz of formula at 9:30 am, more than usual. The patient's breath had a ketone odor. Glucose was 73 to 85. Diagnosis is possibly hyporesponsive hypotonic episode of 1 1/2 hours. Y Y 07/10/2001 07/15/2001 5 WBC=12,000; Glucose, non fasting=73, rechecked again at 1 1/2 hrs = 85 PVT OTH NONE NONE 1
0173495 07/23/2001 OH 0.75 0 .8 M 07/17/2001 The patient presented in the office with a firm knot on his right thigh (palpable) and an erythemic area at the injection site. Y 07/16/2001 07/17/2001 1 NONE PVT PVT NONE NONE NONE 1
0173496 07/23/2001 NY 0.25 0 .3 M 07/17/2001 The patient developed a rectal fever of 100.8F with mild soreness at the injection site. The patient was treated with Tylenol or Motrin. Y 07/16/2001 07/17/2001 1 NONE PVT PVT NONE NONE NONE 1
0173497 07/23/2001 MO 1.0 1 .0 F 07/12/2001 The patient developed hives within 24 hours after receiving vaccines. The patient was treated with Benadryl. On 7/12/2001 the mother called and advised the patient's hives are worse. Y U 07/09/2001 07/10/2001 1 NONE PVT PVT NONE NONE NONE 1
0173498 07/23/2001 PA 40.0 M 07/30/2001 This report describes swollen knees of a 40 year old male who received Lymerix. This report was received from the vaccinee, who is a physician. The vaccinee engaged in recreational running. He self-administered 3 injections of Lymerix; the 3rd was given 1 month, rather that 1 year, following the 2nd injection. Dates of vaccine administration, as well as, vaccine lot numbers, were not recalled by the vaccinee. Approx. 6 months, following the 3rd injection, he experienced the acute onset of bilateral knee pain. The pain soon progressed in intensity and prevented him from participating in recreational running. The pain was described as a diffuse aching' however, it never extended to the popliteal fossa, did not radiate, and did not affect other joints. It sometimes localized deep to the patellas. The knee pain worsened with activity, but there was no diurnal variation in the severity or character of the pain. No erythema was noted. "Slight" intermittent local warmth was noted around the anterior aspect of the left knee. He reported that there had been slight swelling of both knees, but no effusions had been noted. He did not experience fever, morning stiffness, or constitutional symptoms. The vaccinee had not been evaluated by a physician other than himself. Bilateral knee x-rays were reportedly normal. No lab evaluations were performed. The vaccinee treated himself with rofecoxib (Vioxx), celecoxib (Celebrex) and Glucosamine; Glucosamine therapy was continued for over a year. None of the treatments were affective and the bilateral knee swelling, pain, and warmth persisted as of 7/13/01. The adverse events of knee swelling, pain and warmth do not meet ICH serious criteria, but are being submitted as an expedited report by special FDA request per the 6/28/00, letter. Additonal info was received on 07/24/2001. Although the vaccinee denied pre-existing arthritis when reporting his symptoms, he said that he experienced an increase in arthritis symptoms following receipt of LYMErix. The vaccinee told the manufacturer that he had not been evaluated by a physician other than himself, but he told the other manuf. tha the had "sought unspecified medical attention. No outcome was provided. N Bilateral knee x-rays-nml PVT PVT 20010170541 1
0173499 07/23/2001 KS U 07/06/2001 Information has been received from a physician concerning several patients who were exposed to their vaccinated family member who developed shingles. It was not reported if the patients were vaccinated. The family member was vaccinated on 08/18/1995. Subsequently, the patients experienced secondary transmission and it was reported that they developed shingles. The patient's again in approximately 1998 developed shingles for a second time and secondary transmission after exposure to another family member who developed shingles following vaccination with varicella virus vaccine live on 03/14/1998. No further information is available. Y UNK UNK UNK Herpes zoster exposure WAES01060054 1
0173500 07/23/2001 GA 1.25 1 .3 F 07/16/2001 One day post vax, pt's leg was red. Two days post vax, pt's leg started swelling and became warm to touch. Three days post vax, pt diagnosed with cellulitis and given Keflex. Y U 07/13/2001 07/14/2001 1 MIL MIL 1
0173501 07/23/2001 NY 41.0 41 F 07/18/2001 On 7/11/01, pt developed generalized bone pain and left deltoid swelling and pain. She c/o redness in area. On 7/12/01, she developed a feeling of heat in right upper deltoid and also c/o itching. On 7/13/01, symptoms inc in severity. On 7/14/01, she developed temp of 102. On 7/16/01, she returned to work. She was treated with Augmentin 500mg x 10 days. Y Y 07/10/2001 07/11/2001 1 OTH OTH Tapazole Sickle cell trait 1
0173502 07/23/2001 MD 0.3 0 .4 F 07/12/2001 Pt broke out in a papular rash (which blanched on pressure) 72 hrs post vax. She was afebrile but irritable. Y 07/06/2001 07/08/2001 2 PVT PUB NONE 1
0173503 07/23/2001 IL 1.5 1 .6 F 07/07/2001 Pt developed an 8 x 10 area of erythema and tenderness around injection site. Y 06/26/2001 06/27/2001 1 PVT PVT NONE NONE NONE 1
0173505 07/23/2001 NV 61.0 61 F 07/11/2001 Pt c/o left shoulder pain 7 wks post vax. She states it is an ache and that she has had it since vax was administered. It was reported to male nurse at clinic who stated it could be a blood pocket. She has soreness in left upper arm. U 05/17/2001 05/17/2001 0 PUB PVT Aspirin NONE 1
0173506 07/23/2001 AZ 1.9 1 1 M 07/13/2001 Pt's grandmother reported on 7/12/01 that pt's arm was very swollen from the elbow to the shoulder and hot to the touch. She was referred to PMD. PMD reported that pt had a severe localized reaction with induration and pallor from clavicle to elbow. MD requested that pt receive no further DTAP. MD request charted and highlighted on immunization card. Y U 07/10/2001 07/10/2001 0 UNK PUB PUB 1
0173507 07/23/2001 NV 4.0 4 F 07/09/2001 The patient had redness, swelling, pain and warmth of the left arm, possible cellulitis. Y Y 07/05/2001 07/07/2001 2 MIL MIL NONE NONE NONE 1
0173508 07/23/2001 NC 1.0 0 1 M 07/04/2001 Ten days post-vax the patient developed erythema, papular eruption, fever, and Koplik spots in his mouth. Atypical measles are suspected. Y 06/15/2001 06/25/2001 10 NONE PVT PUB NONE NONE NONE NC01061 1
0173509 07/23/2001 MA 1.75 1 .8 F 07/17/2001 The patient experienced swelling of the right arm from the shoulder to the wrist. The area was red and hot to the touch, with itchiness that began 24 hours after the vax and persisted for 5 days after. Y 06/28/2001 06/29/2001 1 PVT PUB NONE NONE 1
0173510 07/23/2001 IA 1.0 1 .1 M 07/16/2001 On 7/12/2001 the patient developed redness and swelling at the injection site. The patient was seen in the ER and diagnosed with a local reaction to the vaccination. The patient was treated with Ibuprofen and Benadryl. The patient experience a tympanic fever of 99.8. Y Y 07/11/2001 07/12/2001 1 NONE PUB OTH NONE NONE NONE IA01009 1
0173511 07/23/2001 WV 22.0 22 F 07/19/2001 The patient developed hives on her arms, legs, abdomen, chest and lips and experienced itching. Y Y 07/19/2001 07/19/2001 0 PVT UNK BCP-Orthotricycline and PPD NONE NONE 1
0173512 07/23/2001 OR 12.0 12 M 07/02/2001 Approximately 5 minutes post-vax the patient had a seizure and fainted. The seizure was not confirmed by the nurses. The patient was pale and slightly disoriented lying down on chairs when observed. Y N 06/12/2001 06/21/2001 9 BP 116/78 PUB UNK NONE NONE 1
0173513 07/23/2001 PA 2.0 1 .1 M 07/16/2001 Had varivax on 8/17/00. Suspected outbreak of varicella on 7/16/01. Y Y 08/17/2000 07/16/2001 333 PVT PUB Albuterol prn Prematurity; asthma; allergy to amoxicillin at 1 month of age. 1
0173515 07/24/2001 GA 1.5 1 .5 M 07/15/2001 Pt had 1st seizure, 2 days, post vax, at 13:00; 2nd seizure was at 19:00 on the same day and a 3rd seizure at 11:00 on 7/1/01. Pt had continued vomiting and diarrhea from early morning (before vaccination) up to 1 week after. Pt is now required to take Tegretol "anti-epileptic" drug for 1 year. Pt seems to have returned to a healthy state. As he is only 18 months, who knows if and when any other symptoms/seizures will occur again. Nurse follow up on 07/27/04 states: "gastroenteritis." Y Y 4 Y 06/28/2001 06/30/2001 2 CT Scan of Brain on 6/30/01-nml; EEG of Brain on 7/3/01-nml; MRI is scheduled for 8/15/01. PVT OTH NONE Had stomach flu and vomiting NONE 1
0173516 07/24/2001 WI 1.3 1 .2 M 07/16/2001 On 04/22/2001 the pt presented to the ER with a temperature of 104.9F and seizing. Seizure lasted 45 minutes. He was riding in the back seat of the family car when his father noticed stiffening of his limbs and an irregular breathing pattern. Did have 2 to 3 days of intermittent nasal congestion, rhinorrhea and cough. Intubated for subsequent respiratory failure using vecuronium and thiopental for 12 hours. Transported by EMS to PICU for stay overnight. Discharge dx: Status epilepticus, mechanical ventilation for less than 12 hours and probable complex febrile seizures. Treatment: IV antibiotics (lorazepam and fosphenytoin) and Neurology consult. Because of findings on the CXR, there were concerns about a possible aspiration pneumonia. The only neurologic finding was some wobbliness with walking consistent with postictal ataxia versus medication intoxication. Plan is to continue on Dilantin until follow-up with Neurology, 1 month post discharge. The Dilantin was discontinued about 1 week after discharge, with rapid resumption of his normal gait, mental status, and coordination. The patient developed another fever 2 weeks after discharge with the temperature ranging from 100F to 102F. This persisted for 3 days and was treated with alternating Tylenol and ibuprofen. Y Y 3 Y 04/12/2001 04/21/2001 9 Head CT-showed possible ventricular dilation but otherwise normal; EEG; CXR-right upper lobe atelectasis, left lower lobe with mild haziness; Lumbar Puncture; Blood, Urine and CSF cultures PVT PVT ibuprofen, Vantin oral suspension rx'd on 4/12/01 X 10 days. UTI with cough, rhinorrhea and left left otitis media but no fever. NONE 1
0173517 07/24/2001 VA 0.5 0 .5 F 07/19/2001 Pt developed fever to > 105 within 24 hours post vax. Y Y 06/21/2001 06/21/2001 0 PVT UNK NONE NONE 1
0173518 07/24/2001 LA 0.25 0 .3 M 07/16/2001 Pt started with high pitched cry and was inconsolable 30 min post vax. It lasted for about 3 hrs. He was taken to MD's office and was given Benadryl and Infant Tylenol. Pt experienced high pitch cry (3 hrs) after first DTAP. Y Y 07/13/2001 07/13/2001 0 NONE PUB PUB NONE Reflux high pitched cry (3 hrs)~DTaP (no brand name)~1~0.00~In Patient LA010703 1
0173519 07/24/2001 PA 0.2 0 .2 F 07/17/2001 Pt developed fever for 24 hrs with a maximum temp of 102.4. Y Y 07/16/2001 07/16/2001 0 NONE PVT PVT NONE NONE 1
0173521 07/24/2001 MA 0.3 0 .3 M 07/18/2001 Pt developed mac-pap rash on both thighs the day immunizations given. He was very fussy and scratching legs. He had similar rash 1-2 days after 2 month immunizations. Y 04/11/2001 04/11/2001 0 PVT UNK NONE NONE rash~Vaccine not specified (no brand name)~~0.20~In Patient 1
0173522 07/24/2001 CA 0.8 0 .9 M 06/30/2001 One day post vax, pt awoke with rash all over and fever but no respiratory problems or face swelling. He was seen on 6/29/01 for negative PPD and had improved. Y Y 06/27/2001 06/28/2001 1 PVT PVT Mycostatin suspension runny nose, oral yeast, probable viral illness NONE 1
0173523 07/24/2001 PA 1.0 1 .0 M 07/19/2001 Pt developed fever and rash. Y 07/09/2001 07/17/2001 8 NONE PVT PVT NONE NONE 1
0173524 07/24/2001 SC 0.2 0 .2 U Pt developed irritability > 4 hrs post vax. Pt developed petechiae to bilateral lower legs. Y 07/17/2001 07/17/2001 0 PVT PUB NONE NONE NONE 1
0173525 07/24/2001 PA 1.0 1 .0 F 07/17/2001 Pt developed fever of 102-103 starting about 4 hrs post vax. She was listless. This lasted 2-3 days. She then had hives for 1-2 days. Y Y 07/09/2001 07/09/2001 0 PVT PVT NONE NONE 1
0173526 07/24/2001 NY 7.0 6 M 07/17/2001 Mom reported very bad reaction. Mom refused appt for pt to be seen. Per phone call on date of report, area had resolved. Y 07/12/2001 07/12/2001 0 PVT UNK 1
0173527 07/24/2001 NY 5.0 5 F 07/17/2001 Mom stated pt had bad reaction but refused appt for pt to be seen. Mom was called on date of report and stated area had resolved. Y 07/12/2001 07/12/2001 0 PVT PVT 1
0173528 07/24/2001 NE F 06/06/2001 Numerous unexplained skin rashes (eczema) all over legs, arms and back. Will fade and reappear and itch. N 09/21/1999 MIL MIL 1
0173530 07/24/2001 TX 54.0 M 05/09/2000 Pt had bruising, 2" around site of shot with a dime-sized nodule, that is ? still present. Y 04/27/2000 04/28/2000 1 MIL MIL 1
0173531 07/24/2001 DC 10.0 10 M 07/19/2001 Six hours post-vax the patient developed a diffuse erythematous, urticaria, pruriticl rash over his entire body. The patient was treated with Benadryl. Y 07/17/2001 07/17/2001 0 NONE PUB PUB NONE NONE NONE 1
0173532 07/24/2001 UT 69.0 69 F 07/16/2001 Two days post vax pt had severe pain in right wrist. Three wks post vax, pt had red rash with hives over entire body. She couldn't write or control the pen. She had a short term memory defect. Her speech was unclear. She had terrible, constant itching and developed rough skin after hives went away. She awoke with eyes swollen shut and face badly swollen. She is almost recovered. Her eyes, skin and short term memory are still slightly affected. Y Y 05/21/2001 05/23/2001 2 PUB PVT NONE Allergy to penicillin, Percodan, Lodine large, red, raised patch on arm~Hep B (no brand name)~1~69.00~In Patient 1
0173533 07/24/2001 OH 1.5 1 .4 M 07/12/2001 On 07/11/2001 the parents reported the patient developed a red swollen grapefruit size area on his left leg. Instructed by RN to administer warm compresses and monitor for increased swelling or streaking. On the evening of 07/11/2001 the patient developed a softball size, blistering center. On 07/12/2001 the patient had a 2x1/2 cm central small blistered area in the left thigh with a 16x10 area of erythema. Doctor advised application of heat to the area and take ibuprofen. Y Y 05/21/2001 05/23/2001 2 PVT PVT NONE NONE NONE 1
0173534 07/24/2001 SC 16.0 15 F 07/16/2001 The patient states two days after each vaccine she developed a rash and hives. After the second vaccine the patient went to the ER with hives all over her body and face, and difficulty breathing when sleeping. ER doctor states the patient either received too much vaccine or it reacted with her system. Y Y 02/16/2001 02/18/2001 2 PUB PUB SC0138 1
0173535 07/24/2001 HI 4.0 4 F 07/09/2001 The patient experienced swelling and redness of the right thigh. Y U 07/06/2001 07/06/2001 0 PVT PUB NONE NONE HI0107 1
0173536 07/24/2001 CA 13.0 14 F 07/17/2001 On 06/28/2001 the patient experienced nausea, vomiting, aching and was warm. These symptoms were treated with ice chips. Y 06/26/2001 06/28/2001 2 NONE OTH PUB NONE NONE Hay Fever 1
0173537 07/24/2001 IL 3.0 3 M 07/19/2001 Post vax the patient experienced redness and swelling from the elbow down and a fever. The mother applied ice and elevated his arm. The doctor said it was a local reaction, and treated it with a steroid injection. The doctor advisede all future shots to be given in the hip. Y Y 07/16/2001 07/16/2001 0 PUB PUB 1
0173538 07/24/2001 PA 13.0 13 M The patient experienced a fever, chest pain, abdominal pain and eleveated blood pressure. Y Y 07/18/2001 07/18/2001 0 CBC, CXR, EKG, Glucose, BUN, Lytes - all wnl PVT UNK NONE NONE 1
0173539 07/24/2001 NY 3.0 3 F 07/20/2001 On 07/19/2001 the patient's step mom called to verify chicken pox outbreak. On 7/20/2001 the patient developed 39 fluid filled areas with red rings around them. The patient has a slight fever with no itching. The patient is being treated with Calamine lotion and Tylenol for the fever. U 09/10/1997 07/19/2001 1408 PVT PVT NONE Bronchiolitis, RAD-asthma 1
0173540 07/24/2001 OH 59.0 59 F 07/19/2001 The patient experienced dizziness, vomiting and fatigue. Y 07/10/2001 07/11/2001 1 OTH PVT Premarin NONE Did not fell well~Hep B (Engerix-B)~1~59.00~In Patient 1
0173541 07/24/2001 PA 4.0 4 F 07/13/2001 On 07/07/2001 the patient awoke complaining of a stomach ache, vomited one time, and had an oral temperature of 105F. The patient was treated with Tylenol and was able to tolerate liquids and small amounts of solid food. The fever never dropped below 100F. The patient did go outside to play at 6:30pm and experienced vomiting again. The patient slept through the night with no further vomiting. On 07/08/2001 the patient had developed a sore lump at the injection site. Treatment with Tylenol continued. A physician visit was not required. Y 07/06/2001 07/07/2001 1 NONE PUB PUB NONE NONE NONE 1
0173542 07/24/2001 AZ 4.0 4 M 07/17/2001 On 07/14/2001 the patient developed erythema. The patient awoke on 07/15/2001 with edema and severe pain in the right upper arm and shoulder. The patient was seen in the ER and treated with Ceclor. The patient had a low grade fever 07/15/2001 through 07/17/2001. Y Y 07/14/2001 07/14/2001 0 PVT PVT NONE NONE NONE 1
0173543 07/24/2001 CO 1.08 1 .1 F 06/29/2001 Within 5 minutes post-vax, the patient developed 2 hives on her upper right arm. One 15mm hive measured adjacent to the Varicella vaccine site and one 10mm hive measured adjacent to the MMR vaccine site. The patient was treated with Benadryl and advised to report this to her pediatrician. Y 06/28/2001 06/28/2001 0 NONE PUB PUB Tylenol NONE NONE CO01011 1
0173544 07/24/2001 TN 4.0 4 M 06/27/2001 Post-vax the patient developed joint pain on 06/25/2001. The patient was seen in the ER and discharged home. On 06/27/2001 the patient was febrile, vomiting, had joint stiffness with pain, weakness and difficulty breathing. The patient is returning to the ER today. Y U 06/18/2001 06/25/2001 7 NONE PUB PUB NONE NONE NONE, had seizure at 8 months old. TN01030 1
0173545 07/24/2001 WA 13.0 13 F The patient reported approximately 36 hours post-vax tightness in her throat, difficulty breathing and swallowing. The patient denied fever, hives, rash, dizziness, nausea, or sensory changes. The patient went to an urgent care center where she was found to be alert and oriented, right upper arm area with warmth, tenderness at the injection site, tonsils mildly enlarged with erythema, nose clear, neck supple, no adenopathy, and no cardiac or respiratory abnormalities. Patients gait was normal, BP 120/72, HR 64, R 16, T 99.3. The patient was treated with Prednisone and Benadryl. Y Y 05/14/2001 05/15/2001 1 NONE PVT PVT Nasalcrom NONE Seasonal allergies, April thru Summer 1
0173546 07/24/2001 PA 4.0 4 F 07/12/2001 The patient experienced redness, warmth, induration, and itchiness in a 7-8 cm diameter area at the injection site with associated axillary adenopathy. Y 07/10/2001 07/11/2001 1 PVT PUB NONE NONE Hearing problems, obesity 1
0173547 07/24/2001 CA 86.0 86 F 07/17/2001 Post-vax the patient experienced localized erythema and tenderson. Y 07/15/2001 07/15/2001 0 NONE PVT PVT Zestril, Coumadin, Niaspan, Verelan, Leseol NONE Hypertension, High Cholesterol, Hypertriglycierides, Atrial Fibrillation 1
0173548 07/24/2001 VA 5.0 4 F 07/19/2001 The patient developed papular urticaria approximately 24 hours post-vax. This was a waxing and waning generalized rash. No respiratory, upper airway, or edema complications. The patient had an erythematous localized reaction at the MMR site. Patient was seen in the clinic and treated with Benadryl. Y 07/17/2001 07/18/2001 1 NONE PVT PVT NONE NONE NONE 1
0173549 07/24/2001 AZ 13.0 13 F 07/12/2001 The patient experienced a syncopal episode approximately 10 minutes post-vax. The patient hit her head on the door and wall, and about 5 seconds later the patient came to and stated she's fine. The patient was reevaluated with a normal ultrasound and neurological exam. Y Y 07/17/2001 07/17/2001 0 NONE PVT UNK NONE NONE 1
0173550 07/25/2001 MI 0.3 0 .4 M 07/18/2001 Pt found unresponsive by baby sitter on 7/17/01. He was taken to ER and pronounced DOA. Unknown reason for death at this time. COD as per autopsy report-- undeterminable Y 07/17/2001 N 07/16/2001 07/17/2001 1 PVT UNK Cystic adenoma malformation/PDA/Prematurity at 35 weeks 1
0173551 07/25/2001 FL F 07/17/2001 Information has been received from a health professional concerning a female who was vaccinated with varicella virus vaccine live. At the time of vaccination, lab evaluation had revealed a negative pregnancy test. Approx. 2 weeks, post vax, the pt told the physician she was pregnant. Approx. 4-6 weeks later, the pt had a miscarriage. Medical attention was sought. No further information is available. Y N Beta-human chorionic-neg at the time of vaccination OTH OTH UNK Pregnancy (LMP-UNK) Concurrent conditions: pregnancy (LMP =UNK) WAES01070470 1
0173554 07/25/2001 MA 38.0 37 M 07/19/2001 Achy, flu-like symptoms, low grade fever, tired. Report 2001017447-1 describes reactive arthritis in a pt who rec'd Lyme disease vaccine recombinant OsPA (Lymerix). This report was rec'd from the pt and has not been verified by a physician or other HCP. The pt had no relevant medical history. Specifically, he had no history of drug allergies, gout, psoriasis, Crohn's disease, or Lyme disease. He had no family history of RA, or lupus erythematous. There were no concurrent medications. The pt rec'd his 1st injection of Lymerix on 4/17/00. He rec'd his 2nd injection of Lymerix approximately 1 mo later, in 5/00. He had no adverse experience following receipt of these 2 injections. He rec'd his 3rd injection of Lymerix on 4/3/01. 2 days later, on 4/5/01, he experienced flu like symptoms, became achy all over, developed a mild low grade fever., and felt tired. These events resolved after 3 days. On 4/9/01, 6 days post immunization, he began to experience joint pain in both ankles. The joints were not red, swollen, or warm. During the first week of 5/01, he was seen by his podiatrist, who noted edema in the second toe on the L foot. The pt was given a non specific diagnosis. Th podiatrist prescribed a 14 day course of celecoxib (Celebrex), which was noneffective. The pt ret'd to the podiatrist approximately 2 wks later. The podiatrist referred the pt to his primary physician. The pt was seen by his primary HCP on 5/16/01. The physician prescribed doxycyceline 100mg daily which was noneffective, The pt ret'd to his primary physician a few days later because the ankle joint pain persisted. He had also begun to experience hand pain, wrist pain, and pain in both hips. He was referred to a rheumatologist. The pt was seen by the rheumatologist on 5/22/01. Physical exam was performed. No joints were noted to be red, warm or swollen. No joint fluid was obtained. No lab evaluations were performed. The rheumatologist increased the doxycyceline dosage to 100mg twice daily, and prescribed ibuprofen 800mg 4 times daily. The doxycycline was noneffective the ibuprofen provided slight improvement. The pt was then seen by an infectious disease specialist. Unspecified test for Lyme disease were again reportedly negative. The infectious disease specialist discontinued doxycycline therapy and referred the pt to his primary physician. At the end of 5/01, the pt was seen by his primary physician and by an internist. A diagnosis of reactive arthritis was reportedly made and ibuprofen therapy was continued. The pt was seen by his primary physician the week of 7/2/01, no change in dx or tx. On 7/13/01 the pt rep'd he could no longer hike or lift weights because of reactive arthritis. He rep'd that he could no longer work a P/T white water raft guide. Therefore, the pt is considered disabled. Y Y N 04/03/2001 04/09/2001 6 x-rays of hand, feet, wrist were all normal. Unspecified lab test for Lyme disease were all negative, lipid levels, uric acid level, ESR, and rheumatoid factor all normal. Antinuclear antibody (ANA) titer was reported to be positive 140. EMG on both arms 5/30/01 reported normal. PVT PVT NONE The pt had no relevant medical history. Specifically, he had no history of drug allergies, gout, psoriasis, Crohn's disease, or Lyme disease. He had no family history or RA or Lupus erythematous. 20010174471 1
0173555 07/25/2001 GA 0.2 0 .2 M 07/19/2001 An attorney alleges that a 2 month old male, now 7 years of age, received an injection of DTAP vaccine on 3/30/94, as part of routine childhood immunizations. In 1999, the reporter alleges that the child was dx'd with mercury poisoning. It is alleged that as a result of the mercury poisoning, the child developed permanent neurological injuries, resulting in "his regression from a normally developing child into a severely impaired individual". The reporter attributes the events to the presence of Thimerosal. No further information was available at the date of this report. Y U 03/30/1994 01/01/1999 1738 UNK OTH OTH UNK UNK UNK HQ3196212JUL2001 1
0173558 07/25/2001 GA 36.0 36 M 07/17/2001 Information has been received from a male consumer with no known drug allergies and no past medical history who in 3/00, was vaccinated with MMRII. In 4/00, the pt was vaccinated with a 2nd dose of MMRII. There were no concomitant medications or current illnesses. In approx. 4/00, the pt experienced flu symptoms and pain in his jaw. It was noted that the pt recovered from the flu symptoms and pain in his jaw. Subsequently, the pt experienced fatigue, numbness in his limbs and internal bleeding. It was reported that "there is a long list of things" the pt had experience. Unspecified medical attention was sought. Upon internal review, internal bleeding was considered to be an "Other Important Medical Event". Additional information has been requested. Also stated abdominal pain, rectal bleeding, facial numbness and tingling, and muscle pain throughout his body. Y Y 04/01/2000 04/01/2000 0 UNK UNK NONE NONE WAES01070500 1
0173559 07/25/2001 PA 36.0 36 M 07/17/2001 Information has been received from a physician concerning a 36 year old pt with no known drug allergies, mild asthma and a history of a traumatic splenectomy at age 16 years who on 6/29/01 was vaccinated in the right arm with pneumococcal vaccine 23 polyvalent. It was noted that the pt had received pneumococcal vaccine 23 polyvalent in the past, with no problems. On approx. 7/1/01, the pt experienced severe pain and swelling of the right axillary lymph nodes and red streaks going down the right arm. The pt went to the hospital and was treated with IV and oral antibiotics. The pt was never admitted to the hospital and was released to home on oral antibiotics. It was reported that, based on clinical findings he presented within the ER, the pt was dx'd with a streptococcal infection. No cultures were performed. The pt is recovering and is finishing his course of oral antibiotics. The reported expressed a concern with the lot 1197K. Upon internal review the pt's experience was considered to be an "Other Important Medical Event". Y N 06/29/2001 07/01/2001 2 OTH OTH UNK Asthma Asthma; Splenectomy WAES01070077 1
0173560 07/25/2001 NY 1.25 1 .3 M 04/18/2002 Information has been received from a physician concerning a 15 month old white male with no family history of seizures, no exposure to toxic chemicals, no history of head trauma who was vaccinated with a dose of MMRII. In the follow-up, the physicuan's office reported that they could not provide a lot number, since "it was not mandatory for the lot numbers to be documented" in 1983. There were no concomitant medications o illness at the time of vaccination. Originally, the physician reported that the pt was vaccinated on 5/11/83, however in follow-up, the physician reported that the vaccine was administered on 4/11/83. In follow-up, the physician reported that the pt was well until 24 hours prior to admission to the hospital on 4/17/83. On 4/16/83, the pt developed a fever of approx. 101 F, which he was treated with aspirin and Tylenol with resolution of the fever. On the PM of 4/17/83, the pt's temperature again increased to approx. 101F. At approx. 04:00, on 4/17/83, the pt's parents heard unusual respiratory noises, they found the child with his eyes open, staring, making grunting respiratory sounds, they could not rouse him. The child was brought by EMS to the hospital. Upon arrival to the ER, the pt was more responsive and alert. The pt's temperature was 101.8F. Physical exam revealed a well nourished male in no distress. The pt's vital signs were stable. The pt was normocephalic, there was pigmented nevus on the scalp. The pt's pupils were equal, round, responsive to light and accommodation. Tympanic membranes were normal. Lymphatics were normal. The pt's neck was supple and there was no significant lymphadenopathy. The pt's chest was symmetrical. Lungs were clear. The pt's heart was regular with a normal sinus rhythm, with no murmurs. The pt's abdomen was soft, non-tender, no organomegaly, no masses. Genitalia was noted as normal, immature male. Extremities were within normal limits. The pt's skin was clear. On neurological exam, the pt was alert, cooperative, no focal deficits, no seizure activity, no tremor, or ataxia. On admission, the pt's chest x-ray was within normal limits. The pt'scomplete blood count (CBC) reveaqled hemoglobin of 9.8 and slighty decreased mean corpuscular volume (MCV). The pt's chemistry panels (SMA 6 AND SMA 12) were within normal limits., with the exception of alkaline phosphates which was over 3,500 which was repeated on separate specimen and confirmed. The pt was dx'd with febrile seizure, questionably secondary to MMR vaccine and elevated alkaline phosphatase, etiology unknown. The pt had no elevation over 101F in 36 hours of hospitalization and was discharged. The pt took phenobarbital for 1 year, post seizure. The pt had 1 more seizure after his initial episode. Previously, the physician reported that the pt had a seizure, was found flaccid on 5/11/83 (which he reported to be one month prior to the episode above). The pt was afebrile. Upon internal review, seizure was determined to be an "Other Important Medical Event". Additional information has been requested. This is an amended report. The responsible physician information has changed and the advers event onset date was changed from 4/17/1983 to 4/16/83. This report is corrected as amended. Follow-up information from medical records indicated that the pt was vaccinated on 05/11/1983, not 04/11/1983 as previously reported, with a dose of MMR. On 05/17/1983 the pt was admitted to the hospital for a seizure and ran a temp of 101.8 deg. F. On 05/10/1983, the pt was discharged from the hospital with a probable seizure and temperature. No treatment was given and the pt did well. His CMA-2 revealed an alk phos >3500 and this was repeated x 1 with the same result. The pt has no evidence of bone or liver disease. The physician's assessment was normal 15 month old. The plan was to repeat an alk phos and calcium/potassium in a week. On 06/10/1983, the pt was seen for congestion and slight cough and was diagnosed with a URI. It was reported that the pt's cousin had Wilson's Disease. NO Kayser Fleischer ring was noted in the pt. On 06/22/1983, the pt experienced another febrile seizure. He was prescribed Pediazole and phenobarbital. Lab tests were performed and were as follows: Ca 10.2; P-5.3; alk phos <80; SGPT-12; SGOT-53; ceruloplasmin 35 (N 18-57). The pt was scheduled for an EEg. On 06/29/1983 it was reported that the pt was doing well. On 07/20/1983, the pt was switched to phenobarbital. It was reported that subsequently the pt recovered. The pt's URI was considered to be incidental findings. No further information is expected. Y Y 3 Y 05/11/1983 05/16/1983 5 CXR-nml; CBC-revealed hemoglobin of 9.8 and slightly decreased mean corpuscular volume (MCV); Chem panels (SMA 6 and SMA 12)-WNL with the exception of alkaline phosphatase which was over 3,500 which was repeated on separate specimen and confirmed; Ca 10.2; P-5.3; alk phos <80; SGPT-12; SGOT-53; ceruloplasmin 35 (N 18-57) PVT PVT NONE pigmented nevus WAES01050178 1
0173565 07/25/2001 CA 3.0 U 07/18/2001 Information has been received from a health professional concerning a 3 year old pt who was vaccinated with a 2nd dose of Hep-B vaccine recombinant (yeast), a 2nd dose of Haemophilus B conjugate vaccine, Prevnar, DPT and poliovirus vaccine. Subsequently, a few hours post vax, the pt experienced a seizure. The pt's outcome was reported as unknown. The pt's seizure was considered to be an "Other Important Medical Event" by the reporter. No further information is available. U OTH OTH UNK WAES01071174 1
0173571 07/25/2001 MI 6.0 M 07/17/2001 Several months post vax, pt developed acute lymphoblastic leukemia. The pt has been on maintenance chemotherapy since the diagnosis. In recent weeks, pt has been exposed to varicella. On approximately 6/26/01, pt developed chickenpox and was hospitalized. MD noted the child's rash was very atypical and the lesions were not "umbilicated." He reported that the case was very mild. The child had less than 200 lesions and no fever or other signs or symptoms. The pt was treated with antibiotics. The question the MD had was "Is this child a primary vaccine failure, or did he have some waning of his immunity due to his chemotherapy?" The outcome of the pt was not reported. Upon internal review, ALL was considered to be an other important medical event. Addtl info has been requested. Y Y U 01/01/1999 01/01/2000 365 Diagnostic lab-one of the pt's lesions was found to be "EIA" negative and "DFA" positive UNK UNK UNK WAES01070341 1
0173573 07/25/2001 MI 0.2 0 .2 F 07/18/2001 Unconsolable crying for several hours, post vax. Pt had a low-grade temperature. Pt admitted to the hospital for 24 hours observation. Diagnosed with intussusception Y 1 Y 07/17/2001 07/17/2001 0 PVT PUB Thrush (oral) 1
0173574 07/25/2001 KS 0.25 0 .2 M 07/17/2001 Eyes rolled back in head, body stiffened, arms went up like goal posts, body shook, stopped shaking for a few seconds but remained in same posture. Then repeated all for 20-30 minutes. Slept but remained in same posture for 30 minutes. Active and alert. Report all at 22:00. ER temperature was 104.5F. Hospitalized. This 2 month old apparently had his regular IZ's at 09:30 including a DPT shot. Mother had been giving Tylenol q 4h as instructed. The child had last fed about 15:00. Apparently the father was playing with the child when he suddenly became quite red in the face, then had stiffening of his extremities, both arms and legs. He seemed to be stiff for a few minutes and then the parents noted his eyes seemed to roll back in his head. He then became limp and just "went to sleep" for severeal minutes. EMS were called to the house and apparently found the pt to have a temp of 104F (rectally) and although they did not chart this on their transfer record, this was confirmed verbally by the nursing staff. The child had been feeding well today. My impression was that this child had suffered a febrile seizure and that the fever was due to his DPT shot. On the way home from the ER, the pt seemed to have another seizure and they turned around and brought him back to ER. In the ER, he continued to have at times tonic type movements, turning his head to the left and rolling his eyes. Mother states he just received his 2 month shots today. A saline lock was placed and we gave him Ativan 0.25mg IV push which resolved those type of movements and then he seemed more dazed and post-ictal. He was transferred to another hospital for septic work-up. I started Cefuroxime 275mg IV piggyback and he received fluid bolus of 10cc per kilogram. Follow up on 08/09/2001: "Patient had been in excellent health, though the mother recounts a few unusual episodes until the day he received his immunizations. He received the immunizations on the morning of 05/30/2001. The mother gave tylenol at 0900 and again at 1500. About 1800, he had a peculiar episode in which he drew his arms up, became stiff and somewhat opisthotonic, and had generalized trembling. He also had ocular deviation cephalad. The whole episode seemed to fluctuate, and he slowly relaxed from the lower extremities on up. When the EMS arrived, he had a temperature of 104. He was ultimately transferred to an institution. A CT scan was normal. An EEG showed a right parietal spike wave focus. LP was negative as well as routine blood studies. The mother relates that he may have had some peculiar episodes in the past. When he had this episode in which his head was turned towards the right at the very end and could not be readily moved she had noted that on one other occasion. Also, several weeks ago when outside he had nother event in which he seemed to be somewhat stiff and had generalized trembling. That also reminded her of the event that he had Tuesday. He slept after that episode, though it was time for his nap and she thought little of it. Thus, within the last several weeks we have two somewhat suspicious episodes, though nothing unequivocal. he is the fourth pregnancy for this now 39-year-old, gravida 4 para 2, two living children, mother. Her third pregnancy resulted in an older brother, then the patient. The mother has migraine and was on Fioricet and some herbal medications during the pregnancy. However he was active in utero. On one occasion, they thought activity was decreased that was around the 23rd week, and as she had felt little movement for about a day, she came in for an exam. However, at the time of that ultrasound he had decided to start moving. she had two other ultrasounds. There were concerns over placenta previa at the 20 week ultrasound and he had another ultrasound around 37 weeks to ensure position. She went into spontaneous labor at term, and he was a spontaneous vertex vaginal delivery with a birth weight of around 8 pounds 3 ounces, comparable to his older brother. The mother was group B beta strep positive. No forceps were used. However, although everything was felt to be going well, by 51 hours he had not urinated. He was thus cathed. Apparently they were suspicious about his uring and thus he was placed on IV antibiotics, though nothing ever gre Y Y 2 Y Y 05/29/2001 05/29/2001 0 MRI-nml; EEG-shows small area of irritability on right parietal lobe; Lumbar Puncture-OK; Blood tests-OK; Urine tests-OK; Pulse 150; RR-28; Pulse Ox 98%; Blood culture-no growth; 2nd trip to ER Temperature 100.2F (rectally); Pulse 150; RR-48; Accu-Chek 100-nml; CT Scan of head-neg for bleed; Catherized urine-no growth; platelet count-high PVT UNK Phenobarbital after seizures NONE UTI at birth 1
0173575 07/25/2001 OR 50.0 F 07/16/2001 I felt sick, four days and then I had no central vision in my left eye. All tests resulted in me not having CSR, MS, genetic tendencies and a conclusion reached that the retina was blistered and now it is concave, scar tissue (too extensive for return of sight). Y N 11/15/1999 Gensfeld electroretinogram ERG; Mulitfocal electroretinogram-Macular degeneration OTH OTH Pt thought she was coming down with a cold NONE 1
0173576 07/25/2001 TN 0.2 F 07/19/2001 Pt found hypotonic/unresponsive with poor respiratory effort approximately 5 hrs post vax. Pt admitted to the hospital for r/o sepsis. Discharged from hospital after cultures negative for 48 hrs. Y Y 3 Y 07/13/2001 07/13/2001 0 Spinal Tap (-); CBC-nml; UA-nml; EKG-nml; ECHO-nml; EEG-nml; Viral cultures are pending PVT PVT NONE NONE NONE 1
0173578 07/25/2001 NY 2.8 2 .9 F 07/24/2001 Biting episodes and screaming on 4/18/01, for hours after. Had generalized convulsion on 4/27/01 X approx. for a few minutes. As per mom, after the episode of convulsion, the child became limp and decreased speaking. Follow-up by neurology clinic for decreased speaking and weakness. Y Y N 04/18/2001 04/18/2001 0 Unremarkable PVT UNK 1
0173579 07/25/2001 NJ 72.0 72 M 07/18/2001 Pt developed pain in left shoulder and, to a lesser extent, in right shoulder that continues as of report. Y U 05/01/1999 05/01/1999 0 PVT PVT NONE 1
0173580 07/25/2001 NC 1.08 1 .1 M 07/19/2001 The patient developed numerous small itchy lesions all over. The lesion on the left thigh at the site of the injection has a 3 cm erythema and induration. Per RN, lesion occurred at site of varivax with other varicella appearing lesions on child's body; not a reaction to Prevnar. Y 07/09/2001 07/18/2001 9 PVT PUB NONE NONE Allergic to Primsol 1
0173581 07/25/2001 AR 1.0 1 .0 F 07/18/2001 The patient experienced nausea, fever, vomiting, runny nose, skin rash, and 10 spots with varicella appearance when seen in the office on 07/17/2001. The patient returned for an office visit on 07/18/2001 with crying and otitis media. There are no new skin rash spots. Y Y 07/09/2001 07/16/2001 7 PVT PUB NONE NONE NONE 1
0173582 07/25/2001 NY 0.2 0 .2 M 07/19/2001 On 07/17/2001 at approximately 1:30pm the patient became very fussy from then until 5:00pm, when he started with a high pitched cry. He was unconsolable for 5 hours and remained afebrile. Y 07/17/2001 07/17/2001 0 NONE PVT PVT NONE NONE NONE 1
0173583 07/25/2001 PA 1.0 1 .0 F 07/19/2001 The patient developed 20-30 vessicles post-vax. Y 06/28/2001 07/11/2001 13 PUB PVT Ibuprofen Hives, birth weight 1040g 1
0173584 07/25/2001 PA 1.0 1 .0 F 07/19/2001 The patient developed 20-30 vessicles. Y 06/28/2001 07/11/2001 13 PUB PVT 29 wk quad - ROP - Hx of GER - Hematuria 1
0173585 07/25/2001 PA 0.08 0 .0 F 07/19/2001 Post-vax the patient developed 20-30 vessicle looking spots. Y 06/28/2000 07/11/2001 378 PUB PVT 29 wk Quads - RAD 1
0173586 07/25/2001 PA 1.0 1 .0 M 07/19/2001 Post-vax the patient developed 20-30 vessicles. Y 06/28/2001 07/11/2001 13 PUB UNK Augmentin Hives, BPD, HTN, Hematuria, 29 wk quad 1
0173587 07/25/2001 TX 1.25 1 .3 F 04/19/2001 The patient experienced a fever of 103.2F at night for 3 nights. The patient had no other symptoms. Y 07/16/2001 07/16/2001 0 PVT PVT NONE NONE NONE 1
0173588 07/25/2001 TN 0.5 0 .3 F 07/19/2001 Patient experienced crying inconsolably for 9 hours. Y 05/25/2001 05/25/2001 0 NONE PVT PVT NONE NONE NONE 1
0173589 07/25/2001 FL 1.2 1 .1 M 07/21/2001 Post-vax the patient experienced a fever ranging from 101 - 102.8F and a rash. Y 06/12/2001 06/20/2001 8 NONE MIL MIL PPD, Amoxicillin 1
0173590 07/25/2001 CA 0.75 0 .8 M 07/17/2001 Within a day post-vax, the patient experienced fussiness, had a pink papular gooseflesh patch on his right lateral thigh. The rash persists to 07/17/2001, when next seen. When given DTaP, Hib and Prevnar on 4/12/2001 at another facility, he had the same reactions plus vomiting. Y Y 07/16/2001 07/17/2001 1 NONE PVT PVT NONE NONE Colic, GERD 1
0173591 07/25/2001 OH 1.08 1 .1 M 07/17/2001 The patient developed a morbilloform rash on his face, trunk and extremities. The diagnosis is MMR reaction vs viral exanthem. Y U 07/09/2001 07/16/2001 7 PVT PVT NONE Rhinitis, Otitis Media NONE 1
0173592 07/25/2001 OR 0.3 0 .4 F 07/18/2001 20 hours post-vax the patient developed a fever. 32 hours post vax the patient experienced a 10-15 minute episode of stiffening, crying, arching back and neck, and staring into space. Resolved spontaneously. 48 hours post vax the patient was fine and with indurated the red area at the injection sites. RN verified that reaction occurred on both thighs where injections were given. Y 07/16/2001 07/17/2001 1 PUB PUB NONE NONE 1
0173593 07/25/2001 AZ 1.0 0 1 M The patient developed a 10cm red patch on his left thigh at the injection site with a 1.2 cm hard knot. Given 2 days before PCV vaccine. Y Y 07/10/2001 07/12/2001 2 NONE PVT PUB NONE NONE NONE 1
0173594 07/25/2001 CA 1.0 1 .0 M 07/12/2001 The patient developed a 4cm x 4cm area of swelling below the right mandible within 5 minutes of vaccine administration. The patient was referred to ENT. U 07/12/2001 07/12/2001 0 MIL MIL NONE NONE 1
0173595 07/25/2001 CO 1.0 1 .0 M 07/18/2001 The patient developed a fever of 101.8F the evening after receiving the vaccine, 06/18/2001. The patient's fever was 103.9F the next day, 06/19/2001 and 106.4F on 06/20/2001. Y Y 06/18/2001 06/18/2001 0 WBC - 27,000 with 606 segs, 206 bands, blood culture - negative, urinalysis and chest x-ray - were normal PVT PVT Otitis medial, conjuctivitis NONE 1
0173596 07/25/2001 IL 0.6 0 .6 F 07/20/2001 Patient developed rash on her face on 07/18/2001. The rash spread to her back, chest and extremities on 07/19/2001. The patient was referred to the ER. Y U 07/18/2001 07/18/2001 0 PUB PUB NONE NONE NONE 1
0173597 07/25/2001 IL 1.5 1 .5 F 07/23/2001 The patient developed an urticarial rash on her face, trunk and extremities and shortness of breath. The patient was treated with Benadryl. Y 07/19/2001 07/19/2001 0 NONE PVT PVT NONE NONE Cough which responds to Albuterol 1
0173598 07/25/2001 OH 0.4 0 .4 M The patient developed fever, pain and irritability. Y 05/02/2001 05/03/2001 1 PVT PVT NONE 1
0173599 07/25/2001 NJ 50.0 50 M 07/19/2001 Pt developed arthritic condition in right hip. He went from normal to barely able to walk in a two week period. Treatments have included Celebrex, hip injections, and physical therapy. The 60 day follow-up states the pain in the right hip remains. Y N 07/12/1999 07/19/1999 7 PVT PVT NONE NONE NONE 1
0173600 07/25/2001 CA 79.0 F 08/17/2001 To date, 08/17/2001 the patient received a flu shot on 10/27/2000 and experienced several days of illness. The patient has had hives off and on to date. The patient never had hives prior to 11/16/2000. Y N 11/16/2000 Blood work PVT PVT Blood pressure pills, vitamins, and aspirin NONE NONE 1
0173601 07/25/2001 CA 70.0 70 F 07/13/2001 The patient developed a cough, esophageal inflammation, a sore throat and hoarseness, shortness of breath, fatigue, and weakness. Y N 11/09/2000 11/11/2000 2 Flexible laryngoscopy, CT chest with contrast, and fiberoptic bronchoscopy OTH UNK Normodyne, Zocor, premarin NONE HTN, ASHD, Elevated Cholesterol ~Influenza (Seasonal) (Fluzone)~1~68.00~In Patient 1
0173602 07/25/2001 CT 24.0 24 F 07/16/2001 On 07/14/2001 at 5AM the patient developed hives and itching on her left and right forearms. On 07/14/2001 at 4PM the patient's hands were swollen, the hives and itching had spread to her hands and feet and she experienced chills. The patient was treated with Deaconess, Nashoba and Benadryl. Y Y 07/13/2001 07/14/2001 1 NONE MIL MIL NONE NONE NONE 1
0173603 07/25/2001 NV 18.0 18 M 07/17/2001 One week post vax, pt called complaining of continued muscle aches and fatigue. U 07/06/2001 07/13/2001 7 NONE PVT PVT Laceration 1
0173604 07/25/2001 NY 5.0 5 F 07/12/2001 Pt developed local skin reaction at site of MMR characterized by 20 cm diameter of erythema and induration. Pt had 2 previous MMR vax, clinically well. N 07/10/2001 07/11/2001 1 NONE PVT UNK NONE Chronic otitis media 1
0173605 07/25/2001 SD 5.0 5 M 07/17/2001 Pt developed macular, papular, vesicular lesions that were pruritic and located on his trunk, extremities, head and top of feet. Mother doesn't think he had an elevated temperature but didn't take temp. He had > 50 lesions lasting about 5 days in staged breakouts. Y 05/23/2001 06/02/2001 10 PUB PUB NONE Dust and pollen allergies (seasonal) treated with Claritin 1
0173606 07/25/2001 OH 26.0 26 F 07/19/2001 Pt developed swollen lymph nodes in neck and groin area. Y N 03/15/2001 03/16/2001 1 Chest X-ray, CBC, Epstein Barr testing-all neg PUB PVT NONE NONE NONE 1
0173607 07/25/2001 CO 23.0 23 F 07/16/2001 Pt broke out in an allergic reaction all over her body on 7/12/01. She developed itching. Pt is not known to have any medication allergies. U 07/09/2001 07/12/2001 3 PUB OTH NONE NONE NONE 1
0173608 07/25/2001 MA 5.0 5 F 07/17/2001 Pt developed a fine, papular rash on face and trunk and a fever as per phone call on 7/14/01. Follow-up on 7/17/01 indicated rash and other symptoms improving. Y 07/09/2001 07/14/2001 5 NONE PVT PUB NONE NONE NONE 1
0173609 07/25/2001 TX 4.0 4 M 07/14/2001 Pt was seen in MD's office 3 days post vax with cellulitis at injection site. Pt was treated with oral antibiotics. Y Y 07/11/2001 07/13/2001 2 PUB UNK NONE NONE 1
0173610 07/25/2001 CA 2.0 1 .5 M 07/23/2001 Pt developed shingles in the axillary dermatome on 7/14/01. Pt had possible exposure to varicella. Pt's recovery was complete after 2 days of Prelone. Y 02/25/2000 07/14/2001 505 NONE PVT PVT NONE NONE NONE 1
0173611 07/25/2001 MO 37.0 37 F Approximately 1 hour post vax, pt developed headache, nausea and stomach pain. Symptoms persisted for 7 days. Pt was seen by MD and given an injection of Demerol for headache pain. Y Y 07/13/2001 07/13/2001 0 NONE OTH PVT NONE Bee sting allergy, diverticulosis, osteoporosis 1
0173612 07/25/2001 MO 9.0 3 F 07/19/2001 Pt developed breakthrough varicella disease. U 08/11/1995 PVT PVT 1
0173613 07/25/2001 FL 2.0 2 .5 F 07/18/2001 Pt's left arm had a hard, raised area covering deltoid with surrounding erythema. Y Y 07/12/2001 07/17/2001 5 PVT PVT Obesity 1
0173614 07/25/2001 OH 1.08 1 .1 M 07/18/2001 Pt started vomiting the day of immunizations and vomited all afternoon and til 9 PM that night. Y 07/17/2001 07/17/2001 0 PUB UNK NONE NONE 1
0173615 07/25/2001 TX 4.0 4 F 07/18/2001 Pt developed redness and swelling on right thigh at site of vaccines 3" wide by 2.5" high. U 07/16/2001 07/17/2001 1 PVT PUB NONE NONE Hypoplasia of depressor angularis oris on right; malformed right ear helix 1
0173616 07/25/2001 NY 44.0 44 F 07/18/2001 Pt presented with headache,body aches, and over all fatigue. Y 06/03/2001 06/04/2001 1 PUB PVT NONE NONE NONE 1
0173617 07/25/2001 GA 0.5 1 .5 F 07/18/2001 1 blister right hip in diaper area appeared 7/18/01 size of dime and fluid filled. Y 07/16/2001 07/18/2001 2 NONE PUB PUB NONE NONE Pollen allergies 1
0173618 07/25/2001 HI 18.0 18 F 02/04/2001 Pt developed subjective, transient choking sensation x 1 episode 2 wks post vax. Pt also had difficulty breathing per mother. Pt was not seen or treated by MD. Y 07/03/2000 07/17/2000 14 PVT PVT NONE Allergy to penicillin/sulfa 1
0173619 07/25/2001 AR 1.25 1 .3 M 07/16/2001 Pt had local erythema and swelling at 24 hours, post vax, with 7cm X 7cm area on anterior thigh (L). Was given Cephalexin po X 10 days for cellulitis vs local reaction. Y Y 07/13/2001 07/14/2001 1 NONE PVT PUB NONE NONE NONE 1
0173620 07/25/2001 CO 1.0 0 1 F 07/20/2001 15 days after vaccine, pt developed fever of 105F + for 5 days and then tell-tale rash of Roseola on 6/26/01. Y Y 06/06/2001 06/21/2001 15 PVT OTH NONE NONE 1
0173621 07/25/2001 NY 5.0 1 .2 F 06/19/2001 Patient vaccinated with VZV on 8/14/97. Pt presented with shingles on right palm to ulnar area at elbow. Diagnosis was confirmed visually by a pediatric dermatologist on 3/12/01. Y Y 08/14/1997 03/12/2001 1306 PVT PVT NONE NONE 1
0173622 07/25/2001 GA 1.0 1 .0 F 07/18/2001 Pt developed unsteady gait, ataxia. Y Y 07/09/2001 07/13/2001 4 PVT PVT Augmentin, Tylenol Otitis media 1
0173624 07/25/2001 TX 25.0 25 F 07/18/2001 Two days post vax, pt developed a 2x2 area of induration and a hematoma at vaccination site to left deltoid area. Pt treated with Westcort. Y 07/16/2001 07/18/2001 2 NONE PVT PUB NONE NONE NONE 1
0173625 07/25/2001 WA 1.0 1 .3 M For 7 days post vax, pt acted fussy and clingy. On 7th day post vax, he developed a rash, and then the following day, he developed a fever. Y 07/05/2001 07/12/2001 7 Strep test throat-neg PVT UNK NONE NONE 1
0173626 07/25/2001 NY 5.0 5 M 07/20/2001 One hour post vax, pt developed angioedema, lower lip swelling, and wheezing. He was treated with Epinephrine, Benadryl and Prednisone. Y Y 07/20/2001 07/20/2001 0 PVT PVT NONE NONE 1
0173627 07/25/2001 OH 48.0 48 F 07/18/2001 Pt developed post TD swelling. She complained of restriction of motion and then pain down into biceps tendon at elbow. She had radicular symptoms down arm into hand and up into shoulder. Y N 07/06/2000 09/27/2000 83 PVT PVT NONE NONE 1
0173628 07/26/2001 FL 0.2 0 .2 M 07/24/2001 Pt was found unresponsive and limp by mother. Twin had same vaccines on same day. Twin was admitted to ER for observation but had no signs and symptoms of distress. Autopsy findings report inguinal lymph node had a subacute lymadenitis with peripheral fibrosis and the spleen is slightly lymphocyte depleted; this infant had atelectasis, a desquamative interstitial pneumonitis and acute and chronic tracheitis. Y 07/21/2001 N 07/20/2001 07/21/2001 1 PVT PUB Augmentin (7/16/01) Infectious adenitis 1
0173632 07/26/2001 TX 1.8 1 .0 F 07/20/2001 Information has been received from a physician concerning a 22 month old female with a milk allergy resulting in diarrhea and no exposure or history of chickenpox who on 4/26/00 was vaccinated in the left leg IM with a dose of varicella virus vaccine live. Subsequently, on 3/3/01, the pt developed a vesiculo-pustular rash on the right side of forehead and right eyelid with swelling and redness around it and right conjunctivitis. The pt also developed herpes zoster described as pre-septal cellulitis on the right eyelid, right forehead and right eye conjunctivitis. She had symptoms of decreased alertness and a temperature of 102.7F. A specimen taken from the pt's right eye was obtained on 3/5/01. The results from the frozen isolate specimen of the child's right eye vesicular lesion was VZV positive and was identified as the OKA/Vaccine strain. Follow-up information has been received from a physician who reported the child has been dx'd with Job-Buckley Syndrome (hyperimmunoglobulinemia E). It was noted that the child's IgE level was in the 1200 range. It was also noted that the pt has eczema and frequent "draining ears". The physician reported that the child was seen with this periorbital cellulitis and it appeared that lesions of herpes zoster also existed. The cellulitis culture grew Hflu, pneumonia, strep and staph and the culture of the child's eye grew the VZV that was identified as the OKA/Vaccine strain. The child was treated in the hospital with antibiotics and acyclovir. The child recovered and the lesions healed, however, there is some residual scarring. Y Y N 04/26/2000 03/03/2001 311 3/5/01 Specimen from right eye lesion-VZV positive and identified as OKA/Vaccine strain; cellulitis culture-Hflu, pneumonia, strep and staph; serum immunoglobulin E-1200 range UNK UNK UNK Food allergy Diarrhea WAES01052943 1
0173634 07/26/2001 OK 0.25 0 .2 M 07/19/2001 Approx. 2.5 hours, post vax, pt started to throw up and then stopped breathing. He was transported to the ER and hospitalized for 2.5 days. Scheduled for allergy testing on 9/6/01 concerning vaccines. Y Y Y 2 Y 06/14/2001 06/14/2001 0 Upper GI-neg; Blood work and chemistry-neg; CXR-neg PVT OTH NONE NONE NONE 1
0173635 07/26/2001 WI 0.3 0 .3 M 07/10/2001 Left mid-thigh swelling to below left knee, fever, pain with flexion of knee (increasing over a 24 hour period). (+) blood culture at 10 hours for pneumococcus. Further serotyping identified it as 23F. IV antibiotics given for 10 day course. Diagnosed with prepatellar cellulitis Y 7 Y 01/22/2001 02/13/2001 22 Blood culture-Pneumococcal serotype 23F; ESR-106; WBC-25.2; leg ultrasound-soft tissue swelling PVT PVT Amoxicillin prior to vaccine; Azithromycin after vaccine ? sinusitis NONE 1
0173636 07/26/2001 CT 4.0 4 M 07/24/2001 Thirty seconds after receiving vax, pt noted to be sneezing a lot. His eyes became red and swollen with swelling of the face. This was followed by respiratory distress and wheezing. Pulse oximetry was 96% on room air. Pt given epinephrine, Benadryl, and Prelone. He was also given Albuterol nebulizer treatment. Y Y 07/17/2001 07/17/2001 0 Pulse oximetry 96% on room air PVT PUB 07/17/2001 PPD 1 previous NONE 36 week premature 1
0173637 07/26/2001 CA 0.5 0 .5 F 07/18/2001 Pt developed twitching of right side of body (seizures) and a temperature of 103. Y U 06/27/2001 06/27/2001 0 NONE PVT PVT NONE NONE 1
0173638 07/26/2001 AL 1.08 1 .0 M 07/18/2001 Pt was hoarse the morning after receiving vax. He had severe diaper rash and congestion noted in the morning 4 days post vax. He had a double ear infection and was treated with Amoxicillin 6 days post vax. He developed a yeast infection. Y Y 06/11/2001 06/12/2001 1 PVT UNK 1
0173639 07/26/2001 AZ 2.0 2 .7 M 07/19/2001 Pt developed erythema and induration of 4-5 cm in anterior right thigh. Y Y 07/17/2001 07/17/2001 0 NONE PVT PUB NONE Fever 2 days before vaccines Pityriasis alba, dry skin 1
0173640 07/26/2001 FL 6.0 6 F 07/19/2001 Mother called around 4 PM one day post vax stating that pt's right arm was swollen, red, hot and had a huge lump. Mother instructed to start pt on Benadryl and apply cold compresses. Y 07/17/2001 07/18/2001 1 PVT UNK 1
0173641 07/26/2001 TN 1.5 1 .5 M 07/24/2001 Pt experienced 2 days of morbilliform rash. Y Y 07/11/2001 07/23/2001 12 PUB UNK Connaught Poliovax, T0841 NONE UNK ~Measles + Mumps + Rubella (MMR II)~1~1.25~In Sibling 1
0173642 07/26/2001 NY 1.5 1 .5 M 07/23/2001 Pt developed a 10 x 8 cm local reaction with tenderness of the left thigh. Y Y 07/19/2001 07/19/2001 0 NONE PVT PVT NONE NONE 1
0173643 07/26/2001 HI 9.0 9 F 07/20/2001 Pt developed a suspected sterile abscess on right deltoid area with 3" of redness, warmth, tenderness and inflammation at site. Y 07/17/2001 07/18/2001 1 NONE PVT PVT Mild URI Cefzil caused hives 5/21/94 1
0173644 07/26/2001 FL 5.0 5 M 07/25/2001 Child had his first DTAP on 7/20/01. Child's mother called on 7/22/01 and said that her son's leg was swollen, red and was the size of a grapefruit. The child had no fever. Mom was instructed to use cold compresses and use Benadryl and to call us if symptoms worsened. Y 07/20/2001 07/21/2001 1 PVT PVT 1
0173645 07/26/2001 FL 5.0 5 F 07/18/2001 Chickenpox breakout Y 06/29/2001 07/10/2001 11 PVT PVT 1
0173646 07/26/2001 NC 4.0 3 F 07/22/2001 Had vaccine on 9/17 in right upper arm. Reaction noticed on 7/20 described as enlarging area of induration, erythema and warm and tenderness especially to the tricep area. U 07/19/2001 07/20/2001 1 PVT UNK 1
0173647 07/26/2001 WI 19.0 19 F 07/20/2001 Pt had chills, sweaty and a headache. She went home and went to bed and slept off and on most of the day. Symptoms lasted until that evening (7/9/01). Y 07/09/2001 07/09/2001 0 NONE PVT PVT NONE NONE 1
0173648 07/26/2001 NV 57.0 57 F 07/18/2001 MMR vaccine administered on 7/2/01. On 7/15/01, pt states she had a rash on her face and stiffness in her joints. By today, she is virtually unable to use her hands, her knees are stiff and sore, as well as, ankles, elbows, wrists and shoulders. Y N 07/02/2001 07/15/2001 13 On 5/23/01-Rubella neg PUB PUB Vitamins, Calcium, Glucosamine Candroytin NONE NONE 1
0173649 07/26/2001 OR 41.0 41 F 07/16/2001 Pt developed pain in shoulder, the afternoon, post vax. Because of pain in left shoulder and even the right shoulder that intensified, pt made multiple ER visits and was evaluated by orthopedist. Gradual improvement over 1 month. Still hurting but no weakness. Y U 06/18/2001 06/18/2001 0 Shoulder MRI: Left bursitis PVT PVT 6/18/01 trazadone, Robaxin, Zyrtec, codeine, Leuquin Arm pain~Td Adsorbed (no brand name)~~30.00~In Patient 1
0173650 07/26/2001 NM 1.5 1 .4 M 07/18/2001 Redness & swelling to injection site, developed 24 hours later and progressed over the next 24 hours. He was started on Atarax. Y 07/16/2001 07/17/2001 1 NONE PVT PUB NONE NONE NONE 1
0173651 07/26/2001 TX 0.6 0 .6 F 07/19/2001 Areas of injection 1 cm below injection site with area of induration around 2 cm x1.5 cm Y 07/18/2001 07/18/2001 0 None PUB PUB NONE Gastroesophageal reflux 1
0173652 07/27/2001 GA 0 .0 F 07/21/2001 Pt became apneic and turned blue approximately 4 hours after immunization. Y Y 2 Y 07/19/2001 07/19/2001 0 Electrolytes and EKG-wnl; septic workup negative PVT PVT NONE NONE NONE 1
0173653 07/27/2001 NJ 54.0 52 F 07/16/2001 Pt developed headaches, leg aches, right hand tiredness, chills, and aching all over. Diagnosed with degenerative joint dx. The follow up received on 9/27/01 states fatigue, flu-like symptoms, bone pain persist. Symptoms worse in cold weather. Feels "like I'm 80 years old when I get up in the morning: none of these symptoms were presnt pre-vaccination. Y Y 8 U 05/14/1999 05/17/1999 3 PVT OTH NONE NONE 04/30/99 torn cartilage left knee; allergic to sulfa, Ibuprofen and ASA (hives, Ceclor; dogs and cats; molds, dust, bayberry 1
0173654 07/27/2001 PA 0.9 0 .9 M 07/20/2001 Generalized urticaria began 1 week after vaccine administration and lasted 1 week Y Y 04/20/2001 04/25/2001 5 PVT PVT Zithromax, Albuterol, Orajel NONE Pneumonia diagnosed on 04/02/2001 1
0173655 07/27/2001 NY 0.3 0 .3 M 07/20/2001 Started crying non stop when Mom got home from PE. Was settled in office after shots. Y 07/20/2001 07/20/2001 0 PVT PVT NONE NONE NONE 1
0173656 07/27/2001 AZ 1.2 1 .4 M 07/19/2001 PCCV given 7/17/01 in left thigh, noted redness on7/1//01 around 2.50 cm to 5 cm medial to injection site. Y 07/17/2001 07/18/2001 1 NONE PVT PUB NONE None NONE 1
0173657 07/27/2001 OH F 08/15/2000 A nurse reported that a female received an injection of 1985-1986 formula influenza virus vaccine, manufacturer unknown, in 1985 and subsequently developed terrible joint problems. No further information was available at the date of this report. U 01/01/1985 UNK OTH OTH UNK UNK UNK HQ9056104JUL2000 1
0173658 07/27/2001 IN 1.0 1 .0 F 07/24/2001 The patient experienced fever and varicella rash. N 07/13/2001 07/21/2001 8 NONE PVT PVT Augmentin NONE Neonatal - CMV - related Hepatitis, resolved and allergic colitis. 1
0173659 07/27/2001 HI 4.0 4 M 07/19/2001 Post vax the patient developed redness and swelling at the immunization site and complained of itching. Y Y 07/17/2001 07/19/2001 2 NONE OTH PUB NONE NONE NONE 1
0173660 07/27/2001 TX 67.0 67 M 07/16/2001 The patient experienced itching, tiredness, and some shortness of breath about 1-2 days post-vax. Y 05/22/2001 05/23/2001 1 Pulse Ox 93-97, CXR- old scarring, CK-91, Sed rate-12, CBC- better than 2000 PVT OTH Prilosec, Cardura, Immunotherapy None NONE 1
0173661 07/27/2001 MA 18.0 18 M 07/18/2001 The patient experienced a syncopal episode 30-40 minutes post vax. The ER findings showed a normal physical exam. The patient is to follow up with non-invasive cardiology. It is not known if there is any causal agent with the vaccine. Y Y 07/17/2001 07/17/2001 0 Blood Sugar - 150, EKG - sinus bradycardia (50-54) PVT PVT NONE NONE Adhesive tape; tincture of benzoin 1
0173662 07/27/2001 GA 1.25 1 .3 M 07/20/2001 Within 5 minutes post vax the injection site swelled to the size of a softball. The injection area was very hot and swollen. A second red area was noticed south of the injection site down the right thigh. This area was swollen, hot and the size of a half dollar. The patient was given Benadryl immediately. Y 07/19/2001 07/19/2001 0 NONE PVT PVT NONE NONE 1
0173664 07/27/2001 OH 1.2 1 .2 F 06/28/2001 Post vax the patient developed diarrhea and vomiting. The patient went to the doctor on 06/26/2001 and was told symptoms were viral and had nothing to do with the immunization. Y 06/22/2001 06/22/2001 0 PUB UNK OH0043 1
0173665 07/27/2001 OH 0.5 0 .4 M 07/09/2001 Following 4/17/01 IZ's pt had tremors and tics. No fever, no crying or fussiness per Mom. Tremors lasted for 1 month. Y Y 04/17/2001 04/18/2001 1 PUB PUB NONE NONE NONE OH0042 1
0173666 07/27/2001 AL 21.0 20 M 07/13/2001 The patient developed swollen lips, a rash on his forehead and on both lower lids and both lower lids were swollen. The skin had a scaly appearance. The family has been treating symptomatically with 1% steroid cream. U 06/28/2001 07/05/2001 7 NONE PUB PUB NONE NONE Pollen and dust allergy. Shrimp makes throat itch. 1
0173667 07/27/2001 MA 1.08 13 F 07/21/2001 The patient developed a large welt on the left arm at the injection site with erythema of the surrounding area. The patient was treated with Benadryl and ice was applied. Y 07/20/2001 07/20/2001 0 PUB PUB NONE NONE 1
0173668 07/27/2001 CT 16.0 F 07/20/2001 Within 15 minutes of receiving the vaccine, the patient began having conjunctival suffusion, lacrimation, nasal stuffiness, and tachycardia. The patient was treated with epinephrine and Benadryl. Y Y PUB PUB NONE NONE MMR vaccine, similar reaction, including wheezing. Wheezing and tachycardia~Measles + Mumps + Rubella (MMR II)~2~11.00~In Patient 1
0173669 07/27/2001 FL 10.0 9 F Patient's hair started falling out a few months after her last shot. The patient has lost 60% of her hair and is still losing hair, though it is growing back in some areas. U 09/13/2000 12/05/2000 83 MIL MIL NONE NONE Allergic to penicillin 1
0173670 07/27/2001 TX 23.0 23 F Approximately 24 hours after the injection the patient's right arm became swollen, painful, red and warm. U 07/07/1998 07/08/1998 1 PUB UNK NONE NONE NONE SA98A 1
0173671 07/27/2001 TX 1.3 1 .4 M The patient's right thigh became red, warm and firm to the touch. Y Y 07/25/1998 07/25/1998 0 PVT PVT NONE NONE NONE SA98B 1
0173672 07/27/2001 TX 15.0 15 M 08/12/1998 The patient developed chills, a fever of 103F, swelling of lips and hands and general weakness post vax. The patient was treated with Benadryl and Tylenol. Y U 08/10/1998 08/10/1998 0 PUB PUB NONE Slight sunburn NONE SA98C 1
0173673 07/27/2001 TX 59.0 59 F 11/12/1998 Post vax patient experienced chills, fever, headache and neck pain. Y U 10/23/1998 10/24/1998 1 CT Scan, lumbar puncture neuro eval PUB PUB NONE NONE High blood pressure SA98D 1
0173663 07/30/2001 OH 39.0 39 F 07/16/2001 The patient states the injection site became reddened and with a hard lump under the surface. The erythema area was reported as softball size. Y 07/13/2001 07/14/2001 1 PUB PUB NONE NONE NONE OH0044 1
0173676 07/30/2001 ID 0.08 0 .0 M 07/21/2001 Pt recvd first Hepatitis B shot at 1 wk old. Within 1 month, his head circumference was noticeably larger. On 10/25/00, pt recvd polio, DPT, HIB and #2 Hepatitis B. Pt developed sessions of high pitched screaming. A full body rash developed. On 12/27/00, he received more polio, DPT and HIB vax. 1/3/01 CT scan showed blood on brain. 1/5/01 he had head surgery to relieve pressure and blood matter. Seizures followed. Doctors deny vaccine adverse event once again. Diagnosed with subdural hemetoma Y Y Y 8 Y U 08/22/2000 09/26/2000 35 Hospital tested for shaken baby syndrome; all test were negative; CT scan showed blood on his brain. PVT OTH Swelling and redness NONE 1
0173677 07/30/2001 MO 1.08 1 .0 M 07/09/2001 Pt received his varicella vaccine on 6-11-01. One week prior to hospitalization, he was exposed to a second cousin with chickenpox. The pt developed chickenpox and pneumonia on 7/5/01 and was admitted to the hospital. He was discharged from the hospital on 7/7/01. Y 2 Y 06/11/2001 07/05/2001 24 PUB PUB NONE NONE NONE MO2001038 1
0173678 07/30/2001 CA 8.0 8 M 07/23/2001 Pt developed Type I Diabetes, dx'd on 12/31/99. Onset of symptoms was approx. 1 month following 2nd shot (given on 4/3/99). "My son developed Type I Diabetes in the few months following his 1st 2 shots in the Hep-B series. I have talked with several doctors, nurses and others, who believe this is directly related to his vaccinations. He did not have any flu or illness prior to getting his dx. He was healthy and active until his Diabetes started. I hope that you use this information and can prevent other children from having the same reaction. I could not get this form from my own pediatrician. I had to go to a doctor we don't know. (It was very difficult to finally get a form)." Y Y Y 3 Y N 07/30/1999 10/07/1999 69 PUB PVT NONE NONE 1
0173679 07/30/2001 IA 85.0 85 M 07/21/2001 Pt was receiving dialysis and transfusion of 1 unit of blood when he had a seizure lasting 2 minutes, tonic-clonic in nature. Y Y 7 Y 04/27/2001 04/30/2001 3 PUB OTH Sinemet, Coreg, Iodid, NaBicarb, Phospholine, Imdur, Previcid, Paxil, Aquephilic, Nephrocaps Generalized weakness Hypertension, COPD (lung dis), IDDM (diabetis mell), A-fib (fibrillat ATR), duodenal ulcer (ulcer duoden), diabetic neuropathy (neuropathy), left eye blindness (blind) ~Influenza (Seasonal) (no brand name)~~0.00~In Patient 1
0173683 07/30/2001 OR 2.0 0 .6 M 07/25/2001 The pt's attorney alleges that "beginning in approximately Sept 1999, pt began to display symptoms of neurological damage consistent with mercury poisoning, including losing his language skills, engaging in repetitive and stereotypical behaviors, suffering from diminished cognitive ability and becoming socially withdrawn. Pt has since been diagnosed as suffering from mercury poisoning and disintegrative (or 'late onset', 'degenerative' or 'regressive') autism." Onset of these symptoms reportedly occurred 9 mos following receipt of the second injection of Engerix-B when the pt was 16 mos old. According to atty, pt developed normally and demonstrated social, language, cognitive, behavioral and physical skills appropriate for his age prior to completing the schedule of thimerosal injections. Atty states pt is receiving treatment to remove mercury from his body and as the mercury levels drop, there is some improvement noted in his symptoms. He states, however, that the pt's injuries are permanent. F/U states developmental history revealed that the child had been "completely normal" according to his mother, until his 2nd birthday. Specifically, at 2 weeks of age, he was alert, startled and regarded face. At 2 months, he lifted his head, followed to midline, smiled and cooed. At 4 months, he had head control, rolled "little", put his hand to his mouth, followed 180 degrees, localized, cooed and laughed. At 6 months, he rolled, pulled himself to sit, transferred objects with his hands and vocalized. At 12 months, he pulled to a standing position, cruised, performed pincer, waved, clapped and was "Dada, Mama-specific". On 5/15/00, at 2 years of age, he climbed steps alone, 1 step at a time, scribbled, followed directions and played with a ball by rolling it back and forth. He appeared to hear well, acted on language and responded to commands. He did not point or know body parts and he did use words. The physician's recommendation was floor time with his mother, beginning with 10 minute sessions. F/U states, On 10/24/00, the mother called the physician to report that the child had been having frequent nosebleeds for the past 2 days and she was advised to increase the humidity in the home and apply petroleum jelly. The parents state that since he had been on the gluten-free and casein-free diet, they have seen astounding changes. He has better eye contact, his language has improved immensely and the applied behavioral analysis (ABA) might work. He also uses the special vitamins that were recommended at the autism conference in early 11/00, which they attended. The child was re-evaluated by the same speech/language pathologist on 12/12/00 and he continues to display language and communication behaviors that are consistent with autism. In the clinic paperwork, the parents noted the reason for referral to be "The child has been dx'd with allergy and mercury-induced autism. We want a review of all tests from a metabolic perspective. Is (his) current protocol appropriate-confirm dx". On the medical history form, under "other serious illness", the parents wrote "Hypogammaglobulinemia, Autoimmune dysfunction, Nodular hyperplasia", under "Systems review", they indicated that the child had "trouble chewing or swallowing" and "appetite is poor". They indicated that the child was not bowel trained and not dry at night and had not learned to ride a tricycle. Y Y N 12/03/1998 09/01/1999 272 Stool specimen-7/13/00-neg for giardia antigen by EIA; 3/14/01 AST, ALT-elevated; lead concentration-below reference range; the blood specimen to be used to measure mercury was clotted, therefore, the test was not done; Plasma ornithine was above nml; slight elevation of the C24/C22 ratio probably of no clincal consequence; hearing-nml OTH OTH Albuterol Allergic to casein-containing foods, gluten-containing foods; asthma; blocked tear ducts 5/24/98; rupture of left tympanic membrane 10/31/98; RSV; URI; Sinusitis; chest colds; conjunctivitis; croup; hand-foot-mouth disease 3/9/99; 4 head injuries; influenza 1/14/00; otitis media; rupture left typanic membrane; pneumonia 11/14/99; potential seizures; RAD 7/24/98; yellow skin 5/14/98 but no treatment; progressive decrease in weight and head circumferance between 12 and 24 months of age; last month of pregnancy, the mother was quite sick and had induced labor; Family history includes father with diabetes as well as maternal grandfather; family history of asthma, RA, ADD, one uncle "was late to begin talking"; enterocolitica encephalopathy 20010175581 1
0173687 07/30/2001 DC 0.5 0 .5 F 07/26/2001 Diffuse urticarial rash developed on morning after vaccinations. First appeared at umbilical region then spread over body. Treated with Benadryl 5mg/kg for 24 hours. Y U 07/24/2001 07/25/2001 1 PVT UNK Eczema 1
0173688 07/30/2001 CA 1.75 1 .8 F 05/07/2001 Pt developed rash to both arms and chest. Pt developed edema to left arm. Pt developed erythema to right arm. Chest had fine, urticarial lesions. Pt was seen in ER and given Benadryl IM on 5/5/01. Y Y 05/04/2001 05/04/2001 0 PUB PUB NONE NONE Left otitis media; Amoxicillin allergy CA010076 1
0173689 07/30/2001 CA 2.0 2 .5 F 06/08/2001 Pt returned to clinic complaining of left deltoid with 5cm X 8cm erythema, non-tender, (+) induration over 3cm X 4cm. Seen by PA and rx'd with Tylenol po every 4 to 6 hours for pain; Benadryl 1/2 tsp po every 4 to 6 hours. Return to clinic prn. Y 06/06/2001 06/08/2001 2 PUB PUB PPD/Connaught/C0153AA/SC/LFA/0 previously NONE NONE CA010077 1
0173690 07/30/2001 CA 1.0 1 .1 F 06/11/2001 Fever to 104F for 2-3 days. Y Y 06/08/2001 06/09/2001 1 NONE PUB PUB NONE NONE NONE CA010078 1
0173691 07/30/2001 CA 0.7 0 .7 F 07/20/2001 Pt experienced facial clenching, eyes bulging, shoulder shrugging and right arm abduction for 10-15 seconds and then hypotonic collapse. Pt then returned to normal state before recurrence of symptoms. There was a decrease in frequency of the symptoms after 1-2 hours. Pt taken to ER. She had no cyanosis or breathing problems. Symptoms resolved by 12:30 AM. Afebrile seizure lasted about 4 hours with no treatment recvd at ER. Y Y 07/19/2001 07/19/2001 0 EEG PVT UNK NONE NONE Premature at 34 wks 1
0173692 07/30/2001 PA 0.5 0 .5 M 07/21/2001 Developed 1cm X 2cm area of erythema overlying 2cm X 3cm area of induration on anterio-lateral aspect of right thigh at site of Hep/Hib vaccine injection. Y 06/19/2001 06/21/2001 2 NONE PVT PVT NONE Mild persistent asthma 1
0173693 07/30/2001 NJ 43.0 F 07/26/2001 The pt received her 1st dose of Lymerix in 5/00. One week later, she experienced right elbow pain and muscle pain. These symptoms resolved after an unspecified period of time. The pt received her 2nd dose of Lymerix in 6/00. The next day, she began to experience "extreme" pain in "every joint in her body". She was seen by a rheumatologist, who reportedly told her that she had "arthritis from vaccine". The pt also mentioned that she has an "impingement problem" in her shoulder, which will require surgery. It was unclear if the "impingement problem" developed before or after immunization. Treatment and outcome of the arthritis and "impingement problem" were not provided. The pt declined to provide contact information for herself and she declined to provide authorization for GSK to contact her physician. Therefore, no additional information will be available. The adverse events of "arthritis", "elbow pain" and "impingement problem" do not meet ICM serious criteria, but are being submitted as an expedited report by special request per the 6/28/00 letter. Y N 06/01/2000 06/02/2000 1 OTH OTH Migraine headaches Migraine headaches Elbow pain and muscle pain~Lyme (LYMErix)~1~0.00~In Patient 20010178851 1
0173694 07/30/2001 UT 44.0 44 F 07/18/2001 On AM of 6/13/01, could not bend or put weight on knees. Pain down shin and up back of thigh and was unable to walk. Doctor visit on 6/14/01 and was referred to Orthopedists. Pt stated Orthopedist dx'd her with Guillain-Barre Syndrome. The annual follow up states that, "pt states that she has permanent disability. Extent of disability is unknown." 60-day and Annual Follow up on 11/17/2003: "It is unknown whether the vaccine recipient recovered from the adverse events that was reported for this vaccination." Y Y N 06/12/2001 06/13/2001 1 X-ray right knee, blood tests, EKG-results unknown to patient PVT PVT Tylenol with codeine; Vioxx; Rx'd Penicillin on 6/12/01 for dx of strep throat Strep throat Osteoarthritis for 10 years, strep throat diagnosed 6/12/01 UT012509 1
0173695 07/30/2001 KY 4.0 4 M 07/27/2001 Inflammatory reaction on left thigh, 2 days, post vax. U 07/25/2001 07/26/2001 1 PVT PUB Keflex Cellulitis secondary to nail puncture NONE 1
0173696 07/30/2001 MO 1.3 1 .4 F 06/28/2001 Mother complained of child crying about 3 hours after shots given. Had temperature of 103F that night, was irritable from 6/21/01 to 6/26/01. No fever since 6/21/01. She did not consult with physician yet but encouraged mother to do so. Y 06/21/2001 06/21/2001 0 PUB PUB NONE Injured left knee NONE MO2001039 1
0173697 07/30/2001 MO 31.0 31 M 07/12/2001 Pt returned to clinic at 12:00 one day post vax stating he had begun experiencing numbness in face and top of head within 10-20 minutes after receiving vax. He pointed to his cheek and jaw area bilaterally. Pt also c/o dizziness. He was accompanied by wife who stated she had stayed up all night with him because they were both worried. Injection site appeared normal, neuro signs were intact, pt was alert and oriented with no deficits noted. Y Y 07/11/2001 07/11/2001 0 BP 102/68; pulse 68 and regular PUB PUB NONE NONE NONE 1
0173698 07/30/2001 VA 11.0 11 M 07/24/2001 Pt given 1st in series of Hep-B (3 doses) and 20 minutes, post vax, student felt "dizzy" and became lethargic. Complained of abdominal pain and a headache. Went to ER where he was given Benadryl. Y Y 07/23/2001 07/23/2001 0 OTH PUB NONE NONE Asthma 1
0173701 07/30/2001 NY 12.0 12 F 07/05/2001 Pt and mother came to clinic today for Hep-B and pt asked if any concerns. Pt stated she fainted in her car after she left the clinic on 6/7/01. Mom stated she "came to" less than 1 minute and felt nauseous. She vomited 3 times that evening and felt fine the next day. Pt stayed at clinic for 20 minutes, post vax, with no complaints on 6/7/01. Hep-B #2 not given today. Y 06/07/2001 06/07/2001 0 NONE PUB PUB NONE NONE NONE NYS21017 1
0173702 07/30/2001 NY 32.0 32 F 06/14/2001 Later in the day of recving vax, pt was exercising on a treadmill which was a new activity for her. About 9-9:30 PM she noticed a fine, red rash on back, across shoulders and a little on chest. It was a little itchy. Rash remained as of 3/28/01. Pt had no other complaints. On 4/4/01, PMD recommended Benadryl with next dose and to continue series. Y 03/27/2001 03/27/2001 0 NONE PUB PVT NONE NONE NONE NYS21016 1
0173703 07/30/2001 NY 12.0 12 F 06/14/2001 Pt developed a pimple-like, non-pruritic, red rash over shoulder blades, both sides of abdomen, both legs and arms. It started 5 days post vax. Mother advised to call PMD, but she did not. She used topical Benadryl for rash and stated pt was fine. Mother encouraged to call PMD for further instructions. No further info obtained. Parent did not return calls. U 05/15/2001 05/20/2001 5 NONE PUB PUB NONE NONE NONE NYS21015 1
0173704 07/30/2001 PA 18.0 18 F 07/23/2001 Pt developed hives within 24 hours of vaccine. Y Y 07/19/2001 07/19/2001 0 NONE PVT PVT NONE NONE NONE 1
0173705 07/30/2001 VA 4.0 4 M 07/20/2001 Local redness, tenderness, induration, morbilliform rash, dependent edema from mid-triceps to elbow. Y U 07/17/2001 07/20/2001 3 PVT PUB NONE NONE 1
0173706 07/30/2001 MD 1.25 1 .0 M 07/20/2001 Pt's mother stated pt's father contracted Ramsey Hunt Syndrome after pt recvd Varivax immunization. Pt's father was seen by another MD for diagnosis. Y 04/02/2001 PVT PVT 1
0173707 07/30/2001 MD 0.2 0 .2 M 07/24/2001 Infant received 3 vaccines about 11:30. Was given acetaminophen and woke up screaming at 14:30; shuddering with jerking of head and shoulder girdle (mild). Parents relate he did this up to 2 weeks of age. By the time he was seen by me, his condition had lessened, considerably at 17:30. Referred to pediatric neurology. U 07/24/2001 07/24/2001 0 NONE PVT PVT Acetaminophen NONE Infant had similar head motions up to 2 weeks of age. 1
0173708 07/30/2001 WA 5.0 5 M 07/22/2001 Pt developed swelling, pain and redness over entire left anterior thigh. He had no generalized rash or systemic symptoms. U 07/20/2001 07/21/2001 1 NONE PVT PUB 1
0173709 07/30/2001 CA 2.0 2 .2 F 07/05/2001 Four hours post vax, pt developed big blotches over entire body, on soles of feet and palms. Her face became swollen and she had a temp of 103. She was treated in the ER with oral Benadryl and the blotches began to subside. Y Y 06/22/2001 06/22/2001 0 PUB PUB NONE NONE CA010079 1
0173710 07/30/2001 WA 1.0 1 .1 M 07/20/2001 Tuesday afternoon, onset of hypotonia like muscle control. falls from walking would result in hitting head because he would be unable to control the forward movement of the head. Drooping eyes, unable to sit, to stand. Unable to look up while in crawling position, has to roll to his side. No ? symptoms as of 7/23/01. Y N 07/16/2001 07/17/2001 1 Stool sent in for Botulism toxic assay PVT PUB NONE NONE NONE 1
0173711 07/30/2001 WI 1.0 1 .4 F 07/23/2001 Within 1-2 minutes of receiving vax, an area approximately 1-1.5 cm diameter that was pink and warm developed. By 11 AM, area had decreased redness and warmth. 07/23/2001 07/23/2001 0 PUB UNK Augmentin for ear infection NONE Ear infection 1
0173712 07/30/2001 NV 46 F 07/12/2001 Pt called on 7/12/01 to report that she has had left arm pain since her hepatitis A injection. She describes the pain as continuous like a toothache. It's zapping me. Pt has not sough any medical follow up. PHN recommended she see a physician asap. U 01/08/2001 01/08/2001 0 NONE PUB PVT B/P medications NONE High blood pressure 1
0173713 07/30/2001 NM 4.0 4 F 07/26/2001 Swelling and redness. U 07/24/2001 07/25/2001 1 PVT PUB NONE NONE NONE 1
0173714 07/30/2001 UT 1.0 1 .0 F 05/29/2001 Left clinic feeling great. No noted problems noted in client until seizure. Ambulance called and taken to ER for observation. No further seizure or treatment. Y Y 10/08/1996 10/12/1996 4 NONE UNK UNK NONE NONE UT012708 1
0173715 07/30/2001 GA 4.0 4 F 07/26/2000 Right leg 9 cm X 9 cm hardened red area. 07/24/2001 07/25/2001 1 PVT PVT NONE NONE NONE 1
0173722 07/30/2001 MI 28.0 M 07/19/2001 Report 2001007581-1 describes night sweats in a pt who rec'd Lyme disease vaccine (Lymerix) for the prevention of Lyme disease. Reportedly the pt had no known drug allergies or medical history. He took no concomitant medications. In November 2000, the pt rec'd his 1st dose in L deltoid of Lymerix without adverse event. In December 2000, the pt rec'd his 2nd dose L deltoid of Lymerix. In January 2001 he became to experience night sweats and fatigue. These adverse events resolved after 3-4 months. As of 6/8/01 the adverse events had resolved. Y 12/01/2000 01/01/2001 31 OTH OTH NONE 20010075811 1
0173725 07/30/2001 NJ 39.0 F 07/19/2001 On an unspecified date, the patient received her second dose of Lymerix. On the injection date, she experienced soreness in the injection arm which lasted 24 hours and resolved. On 04/17/2001, the patient received her third vaccine. On 04/22/2001, the patient noticed a dime-size lump on her left arm approx 1/4 inch above the injection site. The patient was advised to "wait one week" and to treat the lump with warm compresses. As of 04/24/2001, the outcome of the event was ongoing. N 04/17/2001 04/22/2001 5 PVT PUB Doxepin 20010103201 1
0173726 07/30/2001 RI 54.0 54 F 10/12/2001 Beginning on 01/26/2001, post-vax, the patient experienced general arm pain which localized to the injection site and increased with movement. Additionally, she experienced heaviness of the arm that was injected. There was no joint pain. No treatment was given. As of 04/27/2001 the adverse events were unresolved. The follow-up states the pt's medical history included osteoarthritis for which was received rofecoxib. She had no history of Lyme disease. On 07/28/2000, 09/01/2000, adn 01/10/2001, the vaccinee received her first, second, and third .5ml left deltoid doses of LYMErix. There were no adverse events associated with dose 1 and dose 2 of LYMErix. She was treated with Vioxx from 05/03/2001 to 05/07/2001, and Darvocet N-100 one tablet three times daily as needed orally from 05/07/2001. Both MRI and X-rays were negative. The reporting physician indicated that the adversee vents were moderate in severity and were possibly related to LYMErix. He also stated that the adverse events could be associated with administration by chance injuring the sensory nerve. As of 06/29/2001, the adverse events were unresolved. On 10/11/2001m the physician stated that the vacinee had persistent but diminished pain in the area of the injection site. Some relief was obtained with Vioxx. She has seen an orthopedist but was not diagnosed. The physician stated that "it is questionalbe if related to injection or just related in time." The vaccinee had not contacted the physician about this pain for several months but it was reported by the husband one month ago. As of 10/11/2001, the adverse events were unresolved. N 01/10/2001 01/11/2001 1 PVT PVT Vioxx Osteoarthritis 20010107411 1
0173728 07/30/2001 NY 40.0 F 07/19/2001 On unspecified dates, the patient received her first and second doses of Lymerix. Two weeks after dose 2, the patient experienced a left popliteal fossa rash. As of 05/08/2001, the adverse event had resolved. Y OTH OTH Lower extremity lymphedema, motor vehicle accident 20010114321 1
0173729 07/30/2001 PA 34.0 34 M 07/19/2001 On 04/24/2001, the patient received his first right deltoid dose of Lymerix. Ten days later, on 05/04/2001, the patient experienced raised, red bumps on the hands and wrists. The patient was not seen by a physician and no treatment was received. No laboratory tests were performed. As of 05/08/2001, the adverse event was unresolved. N 04/24/2001 05/04/2001 10 OTH OTH Seasonal allergies. 20010115401 1
0173730 07/30/2001 PA 67.0 67 F 07/19/2001 The patient experienced chest pain post vax. This report was received from the patient and has not been confirmed by a physician or other health care professional. Y 05/01/2001 05/04/2001 3 PVT PVT Vanceril, Atrovent Allergic to penicillin, seasonal allergies, emphysema, previously diagnosed with Lyme disease 04/2000, and was treated one month with oral antibiotics. 20010117511 1
0173731 07/30/2001 IN 20.0 M 07/19/2001 Following the third dose of Lymerix, the patient experienced nausea, was "ill at ease" and "turning green", and was anxious. An emergency room visit was required. As of 05/14/2001, the outcome was unknown. Y U OTH OTH 20010118831 1
0173735 07/30/2001 NJ 34.0 34 M 09/24/2001 In May and June of 2000 and approximately 5/22/01, pt recvd first, second, and third doses of Lymerix. Two to three days after dose 3, the pt had fever, chills/shakes, general weakness, and was pale and clammy. He was seen in the ER where labs were drawn and IV fluids and Toradol were administered. The pt seemed to recover until 6/4/01 when symptoms began to return. All symptoms have returned. The pt was seen by an MD on 6/4/01. He was treated with Ceftin for 20 days. As of 6/5/01, the outcome of the events was unresolved. The follow-up states that a motor vehicle accident with unspecified fracture and an unspecified surgical procedure. The vaccinee smoked one pack of cigarettes per day. The vaccinee had no adverse experience following receipt of the firs two doses of LYMErix. The vaccinee was seen by his primary physician on 05/29/2001. This physician noted that a small tick was found on the vaccinee when he was in the ER. The primary physician prescribed a 30 day course of the Ceftinl 500 mg twice daily. As of 07/24/2001, the outcome of the events was unknown. The follow up states that the vaccinee had no adverse experienced following receipt of the first two doses of LYMErix. The vaccinee was seen by his primary physician on 05/29/2001. This physician noted that a small tick was found on the vaccinee when he was inthe ER. The primary physician prescribed a 20 day course of Ceftin. As of 07/24/2001, the outcome of the events was unknown. Y U 05/24/2001 05/26/2001 2 OTH OTH NONE Lyme disease, motor vehicle accident, unspecified fracture, unspecified surgery, smoker 20010137621 1
0173736 07/30/2001 CT 67.0 68 M 07/19/2001 In May and June of 2000, pt recvd first and second doses of Lymerix without adverse event. On 5/31/01, pt recvd his third dose of Lymerix. On 6/1/01, pt stated that his right arm puffed up about 14-15 inches long and that he had cellulitis. That day he went to the ER and was treated with antibiotics which did not agree with him. He was given another antibiotic treatment at a secondary emergency visit one week later. The pt stated that the injection messed up his INR which measured 1.2. As of 6/11/01, the cellulitis had not resolved. Y N 05/31/2001 06/01/2001 1 INR 1.2 OTH OTH Coumadin, Percocet, atenolol, allopurinol, Neurontin, Prilosec, lasix Viral encephalitis, chronic blood clots, pulmonary embolism, hypertension 20010141651 1
0173737 07/30/2001 NJ U 07/19/2001 This report described arthralgia in a vaccinee of unspecified age and gender who received Lyme disease vacicne recombinant. Allergies, medical history, and concomitant medications were not specified. On unspecified dates, the vaccinee recieved an unspecified number of doses of LYMErix. Six months after receiving vaccines, the patient reportedly complained of arthralgia. As of 6/13/01, the outcome of the event was unknown. The adverse event arthralgia does not meet ICH serious criteria, but is being submitted as an expedited report by special FDA request per the 6/28/00 letter. Additional information has been requested. Y PUB OTH Allergies, medical history and concomitant medications were not specified. 2001014635 1
0173719 07/31/2001 TX 29.0 29 F 07/27/2001 About 12:00, I began to have a bad head itch. Rash appeared around the front rim of hairline. Sunday, face was flushed with small bumps and neck was hives. The hives itched. Monday, called MD. Rash had moved to trunk and back. The old hives on face and neck began to widen and turn dark red and began to move to my lips and ears. Tuesday, limbs were covered with itching and unable to sleep at night. Wednesday, blood evaluated. Thursday, had chills, fatigue, itching all over body, nervousness and irritability. Friday, doctor's office. Treated with antibiotic (Prednisone, anti-histamine and creams for external and internal use for itching. Saturday, had high blood pressure, heart rate and temperature of 101.7F. Went to ER and admitted into the hospital and is still being treated. Y Y Y 8 U 06/22/2001 06/22/2001 0 Heart test; liver test; blood level; rheumatoid/lupus level; dermatologist test taken during and after hospitalization OTH OTH Othro Tri-Cyclen; Birth control; back medicine NONE 1
0173720 07/31/2001 FL 0.3 0 .4 M 07/20/2001 Child vomited X 4 on 7/18/01-Brought to PCP's office on 7/19. Had a hypotonic response while waiting to see PCP. Transported to hospital and diagnosed with arachnoid cyst. Y Y 3 Y 07/18/2001 07/19/2001 1 PVT PVT NONE NONE 1
0173721 07/31/2001 IN 0.6 0 .4 F 07/03/2001 About 4 hrs post vax, pt cried very hard, couldn't breathe well and turned pale. She was taken to the ER, given a breathing treatment, and sent home. She was much better when she left the hospital. MD said the problem was from Prevnar. Y Y 04/25/2001 04/25/2001 0 PUB PUB NONE NONE NONE IN200110 1
0173738 07/31/2001 CA 0.25 0 .3 M 07/28/2001 Vaccine (Hib) was given at 10:18 and pt had rash with mild hives that started at 10:23. At 10:38, the rash was still only mild (scant) and at 10:45, the rash and hives were gone except on the bottom of pt's feet and slight on his back. At 11:50, the rash came back on front of his chest, back and legs. At 11:55, the doctor ordered Benadryl X 2 days. At 12:45, the rash almost gone. Pt discharged home with instructions to go to ER or call 911, if the baby becomes worse with rash of if any respiratory problems occur. On 7/30/01 at 08:30, the parent of the baby stated that his rash and hives have been all gone since Sunday. Y 07/28/2001 07/28/2001 0 PUB OTH Benadryl NONE Had previous allergic reaction to IPV/DTAP. 1
0173739 07/31/2001 NY 16.0 15 F 07/27/2001 The child complained of itching of the arms and body and she had a constant dry cough. No difficulty breathing. Epinephrine was given and itching and cough cleared. EMS was called. The child was taken to hospital ER. As per ER doctor, she was discharged on Prednisone. Y Y 05/02/2001 05/02/2001 0 NONE PUB PUB NONE NONE 1
0173740 07/31/2001 MI 33.0 24 F 07/28/2001 Approx. 12 hours, post vax, the pt developed facial tightness, hives behind knees, throat tightness and shakiness. At injection site, she had local reaction with swelling and tightness. VSS, afebrile. She was given 50mg po Benadryl. Recovered uneventfully. Y Y 04/16/1992 04/16/1992 0 NONE PVT OTH Amoxicillin X 24 hours prior History of lidocaine allergy 1
0173741 07/31/2001 IL 0.5 0 .5 F 07/30/2001 Fever of 105F, the evening after vaccines vaccines given (same day). Y 06/20/2001 06/20/2001 0 PVT UNK NONE NONE NONE 1
0173746 08/01/2001 WI 0.2 0 .2 F 07/26/2001 Infant died on 1/19/99. Autopsy report states cause of death to be traumatic head injuries, homicide. Death certificate states: craniocerebral trauma. Y 01/19/1999 N 01/15/1999 01/19/1999 4 PVT OTH UNK 1
0173752 08/01/2001 FL 44.0 44 F 07/23/2001 Information has been received from an RN concerning a 44 year old white female who on 7/19/00 was vaccinated with Hep-B. On 7/19/00, the pt experienced sore left arm, 5" below injection site. The pt was instructed to use a warm compress and Tylenol. As of 7/31/00, the pt continued to have pain and soreness in the left arm below the injection site. On 5/12/01, the pt developed severe pain in left arm that included tingling in the digits of the left hand and numbness in the left hand. In follow-up, the RN reported that on 7/12/01, the pt was dx'd with "spurring". The physician felt that the spurring was not related to the vaccination with Hep-B. Upon internal review, spurring was considered to be an "Other Medical Event". No further information is expected. Y N 07/19/2000 07/19/2000 0 PVT PVT UNK UNK WAES01052034 1
0173753 08/01/2001 11.0 10 M 07/25/2001 Information has been received from a lawyer concerning an 11 year old male pt who allegedly received 16 injections of thimerosal-laden vaccines between 5/6/98 and 4/12/00. On 5/6/98, the pt was vaccinated in the hospital with a 1st dose of Hep-B. On 5/12/99, the pt was vaccinated, IM, in the left thigh with MMRII and a dose, in the left thigh of varicella virus vaccine. It is alleged that prior to completing the schedule of vaccinations, the pt developed normally and demonstrated social language, cognitive, behavioral and physical skills appropriate for his age. Beginning in approx. 9/99, he began to display symptoms of neurological damage consistent with mercury poisoning including losing his language skills, engaging in repetitive and stereotypical behaviors, suffering from diminished cognitive ability and becoming socially withdrawn. It is also alleged that the pt has been dx'd as suffering from mercury poisoning and disintegrative (or "late onset", "degenerative" or "regressive") autism. The pt is receiving medical treatment to remove mercury from his body. As the mercury levels in his body have decreased, he has noted some improvement in his symptoms. Upon internal review, disintegrative autism was determined to be an "Other Important Medical Event". No further information is available. Y N 05/06/1998 09/01/1999 483 PVT OTH UNK UNK WAES01071592 1
0173763 08/01/2001 IL 1.25 M 07/26/2001 On 7/13/01, the pt had difficulty walking and as of 7/16/01 was reported as being unable to walk. The pt also has joint pain, arm pain and a fever of 102-103F. It was noted that the pt had taken Cedax for a few days prior to the vax for an unspecified condition. The MD reported that the pt's inability to walk was secondary to his generalized arthralgias and not secondary to any type of neurological gait abnormality. The pt is recovering. Upon internal review, "difficulty walking and now unable to walk" was determined to be an other important medical event. Addtl info has been requested. Y N 07/03/2001 07/13/2001 10 OTH OTH Cedax Condition unspecified WAES01071568 1
0173765 08/01/2001 MI 6.0 6 F 07/02/2001 Mom gave Tylenol prior to vax and another dose at 4 PM. Pt went to bed at 8 PM. She awoke at between 9 and 10 PM acting strange, eyes crossing, seizing with a temperature of 105-106. She was taken to the ER. She had multiple seizures in ER. She was admitted for 2 days and treated with Phenobarbital. She was diagnosed as having febrile seizures. She was diagnosed with central auditory processing disorder, severe learning disability and language and speech disorder. Y Y 2 Y N 09/22/1995 09/22/1995 0 EEG-wnl; CT scan-neg PVT UNK NONE NONE Transient tachypnea at birth 1
0173766 08/01/2001 TX 0.62 0 .6 F 07/19/2001 Pt developed blisters and bullae on legs and body 2 days post vax. She was seen at ER and transferred to a hospital where she stayed for 3 days. Y Y Y 3 Y 07/02/2001 07/04/2001 2 PVT PUB NONE Sickle cell trait carrier 1
0173767 08/01/2001 TX 0.5 0 .5 F 07/20/2001 Immunizations at 11am. At 2:30pm in ER for seizure activity(limp, eyeballs got rolled up). Temp 100 deg. F with some coughting. Diagnosed with bronchial infection. Per F/U 7/31/02: This pt is a twin. The pt was found unresponsive at home and transported to a hospital, arriving at 21:00 on 4/12/02. She was pronounced dead at 12:49 on 4/15/02. The other twin died on 12/28/01. Four hours, post vax, she developed onset of apnea, cyanosis and seizure-like activity with dragging of her left leg, prgressing to becoming limp. Per autopsy: There are petechial hemorrhages on the lower lobe of the left lung; bronchopneumonia with hyaline membrane formation, capillary congestion, subpleural emphysema alternating with atelectasis. Kidney: acute congestion and the spleen also shows acute congestion. Pathological findings: hypoxic ischemic encephalopathy (clinicaol); severe cerebral edema, marked. Nearly all neurons contained within sections of gray matter show eosinophilic degeneration. White matter vacuolation is seen in all sections. Discharge DX: Seizure reaction to immunization. In ER, pulse-197, RR-44, BP-115/79 and repeat BP-104/65. DX: hypocalcemia; ventricular septal defect. Y 04/15/2002 Y Y Y N 07/10/2001 07/10/2001 0 CBC:1st borderline normal; x-ray: peribronchial coughing. Per F/U 7/31/02: EEG; MRI PUB PVT Per F/U 7/31/02: Amoxil 125mg for cough Per F/U 7/31/02: coughing Per F/U 7/31/02: history of seizure disorder. The pt is a twin and both have suffered from seizure disorder. The 1st twin died on 12/28/01. Prematurity (36 weeks) 1
0173768 08/01/2001 MS 1.0 1 .0 M 07/18/2001 Post vax of 2nd Pertussis vaccine, Pt stopped talking, feeding himself, playing correctly and went into an Autistic state and regressed development. One doctor says he feels adverse reaction due to Pertussis vaccine and would no let pt take the 5th vaccine. The follow-up states that the pt was developmentally advanced before the shots but after the vaccinations he went into autistic state. The annual follow-up states "Asperger's syndrome (autism), low immune system, ADH, Com/social deficits. He has not been the same since he had these vaccinations at age 1 year old. I have to care for and teach him using special one on one techniques and bathe, feed, dress, and give around the clock care. I cannot afford to get help-it changed my life. Doctors have verified vaccine as cause of above. Y N 05/23/1996 05/23/1996 0 PUB PUB NONE NONE allergies and ear, nose, throat problems 1
0173769 08/01/2001 UT 0.2 0 .2 F 07/13/2001 On 8/24/98, at a 2 month check-up, pt received 4 vaccines. That evening, noticed twitching in left hand and left foot. On 9/18/98, pt had twitching in left foot and then on 10/01/98, she had a full seizure. Her nose, lips and tongue were quivering; her pupils were dilated, she was gasping for air and was unresponsive. Her father called 911. She had come out of the seizure by the time EMS arrived. On 10/2/98, she began to twitch again, lasting 4 minutes. Her doctor told us to admit her to the hospital on the same day. They started IV of Phenobarbital and kept her until Sunday. She was prescribed Phenobarbital. We took a family trip on 10/23/98 and she had a big seizure, this time she turned blue and it lasted 4 minutes. We were told to up her Phenobarbital lever to 30ml. On 10/28/98, at her 4 month check-up, she received her 2nd set of shots. That night she ran a fever, we took her in to ER again. They gave her Tylenol. They said she had a urinary tract infection. From this day on, her health started to get worse. Seizures started getting stronger and more often. We asked the doctor about her skin rash, he didn't think much of it. He increased her Phenobarbital lever to 45ml. Every time she had a seizure and they would give her a shot of Ativan. Every time we took her to ER, she started getting diarrhea and rashes very bad on her buttocks. The doctor was very puzzled and he wasn't sure what was causing her problems. He started treating her with Iron, Vitamin B, Phenobarbital, all at the same time. Her health seemed to be deteriorating. She would wake up, have a seizure and fall asleep again. She wasn't eating very much nor drinking much because she was so tired from the seizures and the medication. The doctor had her at a level of 100ml a day for some time. We told him that we didn't think the medications were helping in any way. Her skin was getting rashes and her diarrhea had become very devastating to her skin and hair began to fall out. I had a nurse tell me that she thought my daughter was having an allergic reaction to the medication. I told this to the doctor but he didn't believe this was the case. I called a pharmacy to ask if Phenobarbital has a skin rash associated with an allergic reaction, he said yes it does. The doctor put her on Dilantin, Tegretol, Topamax. None of these medications worked. The doctor's opinion about her prognosis was "I think she is deteriorating" and "all we can do is make her comfortable as possible". I felt the doctor had given up. I elected to inform him that I wanted her taken off all her medications because I told him that nothing he has given her has ever helped her situation. She seemed like she was a zombie most of the time because of high levels of medications she was on. We had to have a monitor at home and oxygen for her because her seizures were getting so close together and lasting more than 5 minutes. Y Y Y Y Y U 08/24/1998 08/24/1998 0 Blood samples; CT scan; Spinal Tap and Urine analysis and all was nml. 10/98, had EEG-showed signs of seizure activity; MRI; Phenobarbital level was done and all was fine. Skin biopsies X 4; EEG X 8; MRI X 4; Spinal Taps X 3; Stool tests PVT UNK Diastat, EMLA, Desowen, Tobradex, Dilantin, Phenobarbital, Cleocin Ped, Fer-Gen-Sol, Zinc, Ceftin, Clonazepam, Nystatin, Bactroban, Tegretol, Spectazole, Sulfatrim, Lactulose syrup, Amoxicillin, Miralax, Cefzil, Lorazepam, Antipyrine/Benzo, 1
0173770 08/01/2001 TX 22.0 22 F Due to lack of pregnancy test, received shot and 2 months later had a spontaneous abortion. Was told fetus never developed past shot date. Y 3 Y 09/18/1998 11/10/1998 53 MIL MIL NONE NONE NONE 1
0173771 08/01/2001 NY 1.44 1 .4 M 06/26/2001 Pt received the 4th Hib on 9/2/94 and within 24 hours, was having tremors all over his body and a fever of 104F. We rushed him to ER and he was examined extensively and sent home with no other symptoms; (viral/bacterial). Y Y N 09/02/1994 09/03/1994 1 blood work PVT UNK None NONE Pyloric Stenosis GI distress, anorexia~DTP + Hib (Tetramune)~2~0.00~Patient|~DTP (no brand name)~1~0.25~Sibling 1
0173772 08/01/2001 MI 0.7 0 .7 F 07/26/2001 About 8 1/2 hours post-vax, the patient developed a fever of 104F along with nausea, vomiting, diarrhea, and loss of appetite. Mother states symptoms would decrease somewhat with Tylenol, but would not completely go away for 4 days. Y Y 01/25/2001 01/25/2001 0 NONE PUB PUB NONE NONE NONE 1
0173773 08/01/2001 OH 1.5 1 .4 M 07/25/2001 The patient came in on 07/25/2001 for a follow-up visit. On exam, the patient was found to have numerous varicella scars on the back of his neck, back and legs. Y Y 06/28/2001 PVT OTH NONE 1
0173774 08/01/2001 SC 1.7 1 .7 M 07/26/2001 The patient developed inflammation of tissue surrounding the injection site to the knee and upper thigh. Y Y 07/24/2001 07/25/2001 1 PVT PVT 1
0173775 08/01/2001 FL 0.3 0 .3 F 07/24/2001 The patient's head turned and jerked to the right side rhythmically, like hiccups. There was no note of her eyes rolling or arms and legs moving. The patient was aware of her surroundings. These symptoms lasted 1 1/2 hours with 50 plus jerks of her head. Y Y 07/23/2001 07/23/2001 0 PVT PUB NONE NONE 1
0173776 08/01/2001 MI 1.08 1 .1 M 07/22/2001 The patient was very cranky 2 days after receiving vaccination. A fever was not noticed until the third day. The fever of 101F lasted 3 days. A week post-vax the patient developed a rash all over his body, except arms, legs and face. There were more than 50 spots, very bad behind his ears and on his scalp. These symptoms lasted more than a week. The pediatrician diagnosed reaction to MMR vaccine. The patient was treated with Tylenol and Benadryl. Y Y 06/19/2001 06/21/2001 2 PUB PUB 1
0173777 08/01/2001 GA 0.5 0 .3 M 07/24/2001 The patient's parents reported the patient had a rash all over his body along with a fever for 2-3 days after vaccines were given at 4 month intervals. The patient was treated with Tylenol. The rash disappeared after 3 days. Y 05/22/2001 05/23/2001 1 PVT PUB NONE NONE NONE 1
0173778 08/01/2001 VA 4.0 4 M 07/20/2001 On 07/19/2001 the patient developed a rash on the right thigh with pain and itching. On 07/20/2001 the patient was seen by a physician for moderate erythema, warmth and edema to the dorsal right thigh. The patient was treated with Claritin and cool compresses to the area. Y Y 07/18/2001 07/19/2001 1 NONE PVT PVT NONE NONE Cyst behind right knee 1
0173779 08/01/2001 MN 1.08 1 .1 M 07/25/2001 On 07/20/2001 the patient developed a rash on his chest, arms and back. On 07/24/2001 the patient developed a temperature and fussy. On 07/25/2001 the patient's temperature continued, the patient had dry heaves and remains fussy with a rash. Y U 07/17/2001 07/20/2001 3 PVT UNK NONE 1
0173780 08/01/2001 UT 15.0 1 .4 M 07/24/2001 The patient experienced a high fever, over 103F for about 1 1/2 weeks. Y Y 06/15/2001 06/16/2001 1 PUB PVT NONE NONE Eczema 1
0173781 08/01/2001 LA 0.3 0 .3 M 07/26/2001 4 hours post vax the patient had wheals above the right eye with fading. Y 07/25/2001 07/25/2001 0 NONE PVT UNK NONE NONE 1
0173782 08/01/2001 OK 4.0 4 M 07/18/2001 On 07/17/2001 the patient's right arm became red, swollen, sore and developed a red blotchie rash at the injection site. On 07/18/2001 the patient was taken to the doctor who said the patient had an allergic reaction to Prevnar. Doctor stated his opinion; reaction 2 hours to Prevnar. Y N 07/16/2001 07/17/2001 1 NONE PUB UNK NONE NONE Hay fever OK0131 1
0173783 08/01/2001 NY 0.8 0 .8 U The patient experienced immediate swelling at the site of the injection followed by urticaria on the chest and leg. Y Y 07/19/2001 07/19/2001 0 PUB UNK NONE Atopic Dermatitis Allergic to egg, wheat and peanuts 1
0173784 08/01/2001 MA 5.0 5 F 07/30/2001 The patient experienced vomiting and fever within 12 hours of receiving the vaccine. The patient had a 7x7cm area of erythema and warmth and increased respiratory rate. Y Y 07/27/2001 07/27/2001 0 PVT PUB Claritin, Flovent NONE Seasonal allergies, motor delay and auditory processing 1
0173785 08/01/2001 VA 1.0 1 .0 M 07/19/2001 The patient developed red splotches of varying sizes, some with purple in the middle, suddenly appearing 7 days post vax. The patient is alert and slightly irritable. On 07/19/2001 the patient saw a pediatrician and was diagnosed with hives. The patient was treated with Periactin. Y N 07/11/2001 07/18/2001 7 PUB PUB NONE NONE VA01022 1
0173786 08/01/2001 MA 0.4 0 .4 F 07/23/2001 The day after immunizations the patient had 2 episodes, 1 minute each, with her head dropping back and to the left, staring straight ahead. The patient was unresponsive with a droop to the left face. There were no limb movements. Y Y 07/17/2001 07/18/2001 1 CT-negative, EEG & Neurological evaluation pending, urine tox-negative, electrolytes-normal PVT PUB NONE NONE NONE 1
0173787 08/01/2001 MS 0.5 0 .5 M 07/24/2001 The patient developed a rash all over his body with a fever of greater than 102.5F. The rash looked like chicken pox without the blisters. The rash was gone within 24 hours. Y 07/20/2001 07/22/2001 2 PVT PVT NONE 1
0173788 08/01/2001 MS 0.5 0 .5 F 07/24/2001 The patient had swelling and redness in the left thigh, along with maculopapular rash all over her body, expecially her face. The patient was treated with Benadryl. Y 07/16/2001 07/18/2001 2 NONE PVT PUB NONE MS01033 1
0173789 08/01/2001 WA 1.6 1 .6 F 07/24/2001 The patient developed erythema with induratum at the left thigh in an area 4 1/2cm x 2cm. The patient had multiple erythematous papules and vesicles. The left thigh had an edematous base with papular lesions scattered over the trunk and arms. U 07/13/2001 07/20/2001 7 NONE PVT UNK Pulmicort NONE Reactive airway disease 1
0173790 08/01/2001 FL 2.0 2 .6 M 07/23/2001 The patient developed cellulitis of the left thigh in an area 15cm x 15cm. Y Y 07/20/2001 07/21/2001 1 PVT PUB Vitamins NONE Sulfa, cyclosporin, allergies 1
0173791 08/01/2001 NE 0.2 0 .2 M 07/24/2001 The patient developed a fever of 101.7F with a sudden onset of lethargy, vomiting and perioral cyanosis. These symptoms occurred within 52 hours post vaccination. There was no specific treatment. Y N 07/19/2001 07/21/2001 2 CXR - mild prominent interstitial lung markings, CBC - 16.9 PVT PVT NONE 1
0173792 08/01/2001 CA 1.25 1 .0 M 07/25/2001 The patient was given the first Prevnar vaccine on 01/23/2001 and developed hives 5 days post vax, lasting 1 1/2 days. The same occurred on 04/24/2001 when the patient was given the second Prevnar vaccine. The patient was treated with Benadryl. Y 04/24/2001 04/29/2001 5 NONE PVT UNK NONE NONE NONE 1
0173793 08/01/2001 WA 0.9 0 .9 M 03/14/2001 The patient developed a diffuse urticaria rash. Y 03/12/2001 03/13/2001 1 MIL MIL Zyrtec NONE NONE 1
0173794 08/01/2001 NY 0.2 0 .2 M 07/24/2001 On 04/17/2001 the patient experienced 4 hours of constant unusual crying beginning 2 hours after vaccines were given. Y 04/17/2001 04/17/2001 0 NONE PVT PVT NONE NONE 1
0173795 08/01/2001 IA 1.0 1 .0 F 07/23/2001 24 hours after receiving injections the patient had a red rash, a fever less than 100F. The rash is generalized, erythematous, and maculopapular eruptions. Y U 07/20/2001 07/21/2001 1 Strep Screen - negative, WBC - 7500 with ml dif PVT PVT NONE NONE NONE IA01010 1
0173802 08/01/2001 CA 40.0 39 F 07/12/2001 Bruising at site, post vax, on 6/19/01. Reports of pain in left arm since shot was given. Y U 12/13/2000 PUB UNK 1
0173803 08/01/2001 PA 3.0 3 U 1 week, post vax, pt developed a hard abscess with surrounding erythema. Dx'd with aseptic abscess. Y 07/17/2001 07/23/2001 6 NONE PVT PVT NONE NONE NONE 1
0173804 08/01/2001 MD M 07/29/2001 Post vax, at 11:10 AM, pt returned to office; coughing/wheezing/itchy and was given Benadryl, 1 tsp. At 11:15, pt was given albuterol per nebulizer; RR-40 with mild retractions. At 11:25, pt was given Epi 1:100, SC, and at 11:28, pt's RR-28, no wheeze and good aeration. Y Y 06/12/2001 06/12/2001 0 NONE PVT PVT Runny nose Allergy to nuts, dust; RAD 1
0173805 08/01/2001 NC 48.0 48 F 07/20/2001 On 7/20/01 pt went to health dept complaining of pain and discomfort in right arm since she received TD on 3/21/01. Two days later she had pain, swelling, aching, hot to touch. No treatment for complaints until 5/01 seen at a Dr. She was referred to PMP over at PMD on 6/01, referred to health dept to report to state via VAERS Y N 03/21/2001 03/23/2001 2 PUB PUB Tegretol, Synthroid, asa, PPD by connaught also on same day as MMR Hashimoto's disease and epilepsy 1
0173806 08/01/2001 NJ 4.0 4 M 07/24/2001 Pt received his vaccines and on 7/20/01. On 7/21/01 pt had large area of redness and swelling on right arm spreading below the right elbow. Due to the area of redness being so large, hot and painful, pt was placed on antibiotics for treatment of cellulitis . Pt recovered on antibiotics and redness was resolved by 7/24/01. Y 07/20/2001 07/21/2001 1 NONE PVT PVT Flovent, Nasonex, Rhinotan, Kandremlel NONE Seasonal allergies, reactive airway disease 1
0173807 08/01/2001 FL 4.0 4 M 07/16/2001 Left arm red and warm to touch, swollen. Ice and Benadryl given at ER visit on 7/14/01. Cape Hospital called in Keflex. Y Y 07/13/2001 07/15/2001 2 PVT OTH NONE NONE 1
0173808 08/01/2001 OH 2.0 1 1 M 07/25/2001 Red spot on both arms. Red ring at sight of injection, still noticeable 11 days after injection. Y 07/09/2001 07/21/2001 12 NONE PVT OTH NONE NONE 1
0173809 08/01/2001 RI 4.0 4 M 07/25/2001 2 inch X 3 inch red rash at site of injection. Y 07/19/2001 07/20/2001 1 PVT OTH NONE NONE 1
0173810 08/01/2001 RI 1.5 1 .3 F 07/25/2001 Area around injectuin site not and red ring about 3 inches in diameter. Y 07/24/2001 07/25/2001 1 PVT OTH NONE 1
0173811 08/01/2001 WA 6.0 6 F 07/09/2001 Flesh colored pruritic pinpoint papular rash arms, torso after vaccines. No constitutional symptoms. On Wednesday gave Benadryl in PM. Parent informed provider 4 days after visit that child had same type of reaction on 9/78/00 after 1st Hep A, but not previous Hep B vaccines. Y 03/29/2001 03/30/2001 1 NONE UNK UNK NONE NONE NONE rash~Hep A (no brand name)~1~6.00~In Patient 1
0173812 08/01/2001 OH 1.5 1 .6 M 07/25/2001 Left thigh swollen, red. U 07/23/2001 07/25/2001 2 NONE PVT PVT 1
0173813 08/01/2001 OR 0.75 0 .8 M 07/20/2001 Rash on arms, bilaterally on 7/12/01; fever 100-102.8 F, 7/15/16/17. Fever down with cool bath and Tylenol. Rash appeared on stomach on 7/19/01 and still present on 7/20/01. Mother reported this to PCP as well as JCHD. N 07/11/2001 07/12/2001 1 NONE PVT PUB NONE NONE egg allergies ~DTaP (no brand name)~~0.00~In Sibling 1
0173814 08/01/2001 MA 1.08 1 .2 F 07/20/2001 Immediate swelling and hives at site, followed by 103F fever for 3 days prior. Given Benadryl at doctor's office and stayed for 30 minutes to make sure breathing would not be effected. U 02/13/2001 02/13/2001 0 MRI, endoscopy, x-ray, cat scan, EEG, blood work, surgery for G tube- No results in chart PVT OTH NONE NONE Delayed development~Measles + Mumps + Rubella (no brand name)~1~1.00~Patient 1
0173815 08/01/2001 GA 4.0 4 F 07/28/2001 2 days after vaccination the right thigh was red, tender, and very swollen. Increase in symptoms and then decrease in symptoms by day # 4. Y Y 07/20/2001 07/22/2001 2 NONE PVT PVT NONE NONE NONE 1
0173816 08/01/2001 OR 1.0 1 .0 F 07/20/2001 Shingles left side of trunk-improving, still has rash. Y Y 12/30/1998 07/16/2001 929 NONE PVT OTH Bronchitis NONE 1
0173817 08/01/2001 SC 1.2 1 .2 F 07/27/2001 1 week after shot pt developed a rash on abdomen and back and fever. Mom reports 102 F. Y Y 07/18/2001 07/26/2001 8 PVT PUB Lorabid, Benadryl, Zyrtec NONE NONE 1
0173818 08/01/2001 CO 5.0 5 F 07/18/2001 Tachycardia and wheezing at 24 hours Y U 07/16/2001 07/17/2001 1 PVT PVT NONE 1
0173819 08/01/2001 NH 5.0 5 M 07/27/2001 Localized allergic reaction to left arm. 7-8 cm area of erythema, warmth and swelling. Non tender to palpitation. Pt complained of itching, not pain. Y 07/24/2001 07/25/2001 1 NONE PVT PUB NONE NONE Penicillin gives pt rash, DPT rxn in past inconsolable crying inconsolable crying~DT Adsorbed (no brand name)~2~0.30~In Patient 1
0173820 08/01/2001 CA 4.0 M 07/26/2001 Pt seen at our clinic on 6/27/01 with varicella zoster on left arm and back. Did not return for follow-up. Follow up on 08/21/2002: "The immunization was not given at our site." Y U NONE UNK UNK 1
0173821 08/01/2001 MT 5.0 5 M 07/26/2001 Pt developed hives and was treated with oral antihistamine. Rx given today. U 07/25/2001 07/25/2001 0 MIL MIL NONE NONE 1
0173822 08/01/2001 FL 10.0 5 M 07/26/2001 Pt received varivax on 5/8/96 and came to office on 6/16/01 with vaccine failure and clinical case of chicken pox. Y 05/08/1996 06/16/2001 1865 NONE PVT OTH NONE NONE Allergies; asthma 1
0173823 08/01/2001 CA 32.0 32 M 07/26/2001 Severe joint pain, numbness, tingling and twitching of extremities, fatigue, weight loss, tinnitus, tactile illusions, pain and sluggishness in right leg. Y N 02/20/2001 02/21/2001 1 PVT PVT NONE NONE NONE 1
0173824 08/01/2001 IL 4.0 4 M 07/26/2001 Fever, mild swelling, red with mild edema; started the night after vaccine. Came to clinic 2 days, post vax, and was advised to use cold compresses every 3 hours for 15 minutes. Antibiotic started. Y 07/23/2001 07/23/2001 0 NONE PUB PUB NONE NONE Redness and swelling~DTaP (no brand name)~4~2.00~In Patient 1
0173825 08/01/2001 PA 5.0 5 F 07/19/2001 4" circular, warm area on RUA; 2" inner area, more firm. (DTAP given in that area). U 07/13/2001 PVT UNK NONE NONE 1
0173826 08/01/2001 MA 4.0 4 M 07/25/2001 Erythema, edema, 8.5cm X 7cm on left deltoid area. DTAP was given on that area, 24 hours ago (5th dose). Y 07/23/2001 07/24/2001 1 PVT PUB NONE NONE 1
0173827 08/01/2001 TX 4.0 4 M 07/25/2001 Erythematous area on right leg/thigh 4 1/2" X 4 1/2". No cellulitis. No oozing. No fever and not warm to touch. Rx'd po Benadryl every 6 hours X 24 hours and po Advil. Follow-up as needed. Seen today for 1st time. U 07/23/2001 07/24/2001 1 NONE PVT PVT NONE NONE Asthma; GERD Reflux 1
0173828 08/01/2001 MD 8.0 3 F 07/30/2001 On 7/10/01, pt had several red macular/papular lesions on neck, trunk and extremities and palms. Also had a headache. Later in the day, had increased number of lesions. Treated with Benadryl and Aveeno as needed. Y 03/24/1997 07/10/2001 1569 PVT PVT NONE 1
0173829 08/01/2001 WV 1.0 1 .0 F 07/25/2001 Varicella/pox rash, 10 days, post vax. Y Y 07/11/2001 07/23/2001 12 PVT PUB NONE NONE NONE 1
0173830 08/01/2001 FL 12.0 12 M 07/25/2001 On 7/21/01, right arm where TD booster was given turned red and hot. Went to ER around 19:00 and doctor dx'd adverse reaction and Rx'd him with antibiotic. Y Y 07/19/2001 07/21/2001 2 NONE OTH PUB NONE Proteinuria NONE 1
0173831 08/01/2001 PA 24.0 24 F 07/25/2001 Swollen arm from shoulder to elbow, very hot, lump, black and blue. Skin peeled. Took Keflex 500mg. Lump still there and has been ordered X-ray. Y N 07/05/2001 07/07/2001 2 PUB PVT Naprosyn, OCP, Azulfidine, Zantac Arthritis Arthritis 1
0173832 08/01/2001 PA 5.0 5 M 07/24/2001 Pt started with redness and swelling in left arm around the site of injection, 24 hours, post vax. Seen in office at 48 hours, post vax, when mom came in and child had erythema, swelling, tenderness and warmth in all upper arm around shot site. Cellulitis evident and started on Augmentin 400mg bid X 10 days. U 07/19/2001 07/20/2001 1 PVT UNK NONE Wolf-Parkinson-White Syndrome (heart condition) 1
0173833 08/01/2001 CA 58.0 59 M 07/24/2001 Day 1 pt developed soreness at site which slowly crept over whole body in the next 24 hours, "like the flu." Day 2 pt stated body sore and muscle aches. Day 3 pt had high temperature and felt delirious. Day 4 pt continued with temp to 103. Day 5 Temp broke in early AM only to return but milder by mid-day. Pt had no nausea, vomiting, diarrhea, cough or headache. U 07/20/2001 07/21/2001 1 NONE PUB PVT NONE NONE NONE 1
0173835 08/01/2001 NE 4.0 4 F 07/24/2001 Mom called office on 7/19/01, stating pt's right thigh was red, warm and swollen to softball size. No temperature, SOB or N/V. States pt voicing no complaints. Told to ice and give analgesics. On 7/24/01, mom called to follow-up with pt's status. States pt is better. No redness or warmth but continued with hard, swollen, quarter-sized area. Y 07/18/2001 07/19/2001 1 PVT PUB NONE Scalp lesion Impetigo 1
0173836 08/01/2001 NE 1.9 1 .9 F 06/28/2001 Blistering vesicular rash, almost cellulitis in nature, in leg with DTAP and IPV. Y U 06/18/2001 06/19/2001 1 PVT PUB NONE 1
0173837 08/01/2001 TX 3.0 1 .0 U Varicella disease on 6/13/01 (mild case). Y 06/09/1999 06/13/2001 735 PVT PVT NONE NONE NONE 1
0173838 08/01/2001 OH 1.5 1 .5 F Crying and walking away (another child's toy taken away) and suddenly arched head, arms and back backward and fell prone, when rolled over/picked up, eyes rolled back and face was blue and not breathing. Head cocked to the right, arms flexed up, fists tightly clinched (911 called). Pt remained like this approx. 1 to 1.5 minutes then shook head, fluttered eyelids 5 times, opened eyes and started crying. The next day, she had red welt size of her deltoid, appeared. Y Y 06/14/2001 06/14/2001 0 On 6/15-EKG-"No irregular heart rhythm. On 6/19-sleep deprived EEG-neg (no seizure activity) PVT UNK Cough X 10 days 1
0173839 08/01/2001 WI 5.0 5 F 07/27/2001 Per telephone call from pt's mother; pt developed a rash to chest and upper thighs, 24 hours, post vax. Rash "looks like red, raised bumps" and she is complaining of itching but not severe. U 07/24/2001 07/25/2001 1 PUB PUB NONE NONE NONE 1
0173840 08/01/2001 OK 2.0 2 .7 M 07/25/2001 On 7/24/01, phone call from mom, reports Daycare states child had raised red spots on chest, back, arms and legs. She had given him some Benadryl in the AM for stuffy nose and reports history of allergy to cats. On 7/25/01, phone call to mom; she reports child had 101F temperature and clear diarrhea last night and still has rash. She called PMD and he Rx'd Benadryl, Tylenol and fluids. U 07/23/2001 07/24/2001 1 NONE PUB UNK Stuffy nose 1
0173841 08/01/2001 IL 3.0 3 M 07/26/2001 Right thigh injection site has red, hot and indurated area encompassing about 1/3 of anterior surface of thigh. Actual injection site with 1cm clearing wound injection area; small vesicular lesion by site. Pt febrile which started immediately. Y 07/03/2001 07/03/2001 0 PVT UNK Cystic Fibrosis 1
0173842 08/01/2001 FL 0.91 0 .9 M 07/24/2001 1 1/2-2 hours after vaccination child was very fussy, crying, appeared to be in pain, jerking himself backward, skin flushed on face. Pt developed hives on head. Per Dr instruction gave Benadryl and he improved with Benadryl Y 06/07/2001 06/17/2001 10 Refered for allergy testing with Dr 08/07/2001. PVT PVT NONE 3 weeks prior pt had sinus infection and was treated with antibiotics Bilateral Hydronephrosis congenital, and asthma 1
0173843 08/01/2001 WA 12.0 12 M Pt received IZ on 7/25. Mother called today and told of itchy and local facial rash. U 07/25/2001 07/27/2001 2 PVT PUB NONE NONE Broken ankles 1
0173844 08/01/2001 TX 48.0 48 F 07/20/2001 On 4/5/01 large local reaction that got worse. Was seen by ER doctor and given RX for Keflex to treat cellulitis. Y Y 04/02/2001 04/04/2001 2 Had PPD done on 03-19-01 PVT PVT Estrogen, Motrin NONE Allergy to shell fish 1
0173845 08/01/2001 FL 5.0 5 F 07/24/2001 Pt received varivax in the left arm SQ and had a blood draw. Five minutes later she felt nauseous and dizzy and was pale. BP was decreased from 90/60 to 80/40. She had weak pulse and cool extremities. She was layed flat and given O2 X 5-10 minutes. She then recovered and was transferred to ER and observed briefly and was discharged home. Y Y 07/24/2001 07/24/2001 0 NONE PVT PUB NONE Possible stomach virus the day before the vaccine 1
0173846 08/01/2001 LA 1.0 1 .1 M 07/26/2001 Within 24 hours of administration of vaccines child had a febrile seizure with a temperature of 103 F. Y Y 07/19/2001 07/19/2001 0 Nl-CBC, nl-chem 8, BC-NG PVT UNK NONE NONE 1
0173847 08/01/2001 DE 37.0 37 F 07/27/2001 On 07/59/01 pt called our office and stated varicella vaccination site was red, warm, painful, itchy, raised approximately 2 inches by 3 inches and looked like an allergic reaction. Pt seen by MD on //site was red, mildly tender and raised aprroximately 7 X 8 cm. Motrin and ice was recommended. Y 07/24/2001 07/24/2001 0 OTH PUB BCC, iron, MVI NONE positive PPD, mennoraghia, allergic rhinitis 1
0173848 08/01/2001 TX 4.0 4 M 07/24/2001 On 7/19/01, pt had swollen left thigh with rash approximately 10 cm x 8 cm. There were no complaints of pain. Pt given Benadryl for rash and heat packs. Y Y 07/17/2001 07/19/2001 2 PUB PUB Anemia ADHD SA0108 1
0173849 08/01/2001 CO 1.75 1 .8 F Pt developed swelling and redness at administration site. Y Y 07/26/2001 07/26/2001 0 PVT PVT NONE 1
0173850 08/01/2001 VA 1.0 1 .0 F 07/26/2001 Pt had a febrile seizure on 7/2/01 and 2 episodes of breaking out with pruritus in same place on body. Y Y 06/01/2001 07/01/2001 30 CBC-nl; blood culture-neg PVT PVT Fever 1
0173851 08/01/2001 CA 12.0 12 F 07/18/2001 At 17:00, pt had temperature of 101F and reached 105.9F at 08:00 today. Pt was taken to ER. Pt was discharged 3 hours later. At 14:00, the pt's temperature was 100F. Mother had given pt ibuprofen 200mg every 4 hours without any effect on her temperature. On 7/19/01, the pt's temperature was 100F. Y U 07/17/2001 07/17/2001 0 PUB PUB NONE NONE NONE CA010080 1
0173852 08/01/2001 MI 0.6 0 .6 M 06/28/2001 Pt recvd vax in AM. That night around 7 PM he developed a swollen neck and itching. He has eczema. He was given APGC (a homeopathic med). Y 06/25/2001 06/25/2001 0 PUB PUB Eczema Eczema MI2001053 1
0173853 08/01/2001 IN 1.0 1 .0 F 07/25/2001 Pt developed a widespread, confluent urticarial rash with sandpaper feel on abdomen and back. There was no involvement of extremities or face. It lasted about 24 hrs and improved with Benadryl. Y Y 07/24/2001 07/24/2001 0 NONE PUB PUB NONE NONE NONE 1
0173854 08/01/2001 OK 4.0 4 M 07/19/2001 On 7/19/01, pt presented to clinic c/o swelling in left upper arm. Pt unreliable on reporting pain-at first says it hurts, then says it doesn't. Father reports pt acting and eating normally. Pt moves about frequently with active arm movement. Y Y 07/17/2001 07/19/2001 2 NONE PUB PUB NONE Some kind of diet allergy reported by father OK0133 1
0173855 08/01/2001 OK 16.2 16 F 07/19/2001 Pt c/o itching over right arm, chest and back. It progressed to itching all over and large wheals appearing over back, chest and right arm by 21:00. Mother called ER and was instructed to give pt Benadryl 50mg. Pt's signs and symptoms did not resolve so went to ER. Rash and itching resolved by 22:30. Pt's mother notified private MD and was instructed to notify health dept. Y Y 07/18/2001 07/18/2001 0 NONE PUB PUB NONE NONE NONE OK0132 1
0173856 08/01/2001 CA 2.0 2 .7 F 07/27/2001 On 7/26/01, pt came to clinic with LVL swollen, red, tender with induration measuring 8 x 11 cm. It was a probable reaction to DTAP. Y Y 07/25/2001 07/25/2001 0 NONE PUB PUB NONE 1
0173796 08/02/2001 KY 1.0 1 .0 F 07/23/2001 Fever increased to 105.6F. Y 1 Y 07/10/2001 07/18/2001 8 CBC PVT PUB NONE NONE NONE KY2001053 1
0173800 08/02/2001 MO 26.0 26 F 07/27/2001 Pt had a rash on arms, welts on abdomen and back with itching. Also had trouble swallowing. Y Y 1 Y 07/12/2001 07/13/2001 1 Rabies screen? PUB OTH Rabies IG given in ER at hospital; just finished Augmentin and Viaxin. NONE NONE 1
0173834 08/02/2001 WA 37.0 35 M 07/06/2001 Tremors in arms and legs and fatigue, ongoing from approx. May, 1999. No treatment at this time. Seeing a neurologist at hospital. N 11/10/1998 05/01/1999 172 MIL MIL NONE NONE 1
0173876 08/02/2001 NE 37.0 36 F 07/27/2001 Information has been received from a health care professional concerning a patient who in September 1995, was vaccinated with MMRII. In 1996, the patient experienced negative antibodies. In April 1996, the titer was drawn with negative results. The reported indicated another patient with a similar experience. No further details were provided. U 09/01/1995 01/01/1996 122 Titer-negative OTH OTH UNK UNK WAES96061792 1
0173877 08/02/2001 NE 2.0 1 .1 F 07/27/2001 On 02/12/1996 the patient developed a rash. While on steroids the patient developed RSV virus which required respiratory treatments. The patient was treated with Pediapred and Atrarax. Subsequently, the patient recovered from her experience. Y 02/06/1996 02/12/1997 372 UNK UNK UNK WAES97021383 1
0173879 08/02/2001 CA 36.0 35 F 07/27/2001 In 1998 the patient was vaccinated with one does of rubella virus vaccine. Subsequently, the patient developed rheumatoid arthritis, which she claims was caused by the vaccination. The patient sought unspecified medical attention. At the time of the report, 09/05/2000, the patient still suffers from the rheumatoid arthritis. No further details were provided. Y N 01/01/1988 OTH OTH UNK UNK WAES00090143 1
0173880 08/02/2001 AZ 4.0 4 F 07/27/2001 5-10 seconds of stiffening of arms and legs. No obvious clonic/tonic movements. This was with extreme crying after the last shot (MMR). No LOC. observed. No treatment necessary. Went home after 15 minutes of observation. Y 07/27/2001 07/27/2001 0 NONE PVT PVT NONE NONE 1
0173881 08/02/2001 IL 0.5 0 .6 F 07/27/2001 Pt's right leg was swollen, red and had a knot. Y Y 07/25/2001 07/26/2001 1 PUB UNK 1
0173882 08/02/2001 HI 1.75 1 .8 M 07/13/2001 Pt had local swelling and redness with increased warmth about 4cm X 5cm. Y U 07/11/2001 07/12/2001 1 NONE PUB OTH NONE NONE NONE HI0108 1
0173883 08/02/2001 IN 47.0 47 F 07/16/2001 When I tried to get up, the room got black and I just about passed out. My heart was racing, I was clammy and sweaty and it was hard to breathe. This lasted about 2 hours. I recovered slowly. I called my husband and he came home from work. They didn't warn me of any of this kind of reaction and neither did my doctor. He should have. Y Y 06/05/2001 06/05/2001 0 NONE PUB PVT NONE Allergic to Darvacet pain killers. 1
0173884 08/02/2001 TX 53.0 53 F 07/26/2001 24 hours, post vax, I started feeling hot and dizzy and my arm started feeling heavy. I went ER at approx. 22:00, Saturday night, the 16th. On Sunday morning, I felt worse. My arm was sore, I could barely move it. I looked in the mirror and the site of the TD had a red circle around it and from the site down to almost my elbow looked like cottage cheese and was red. It was red all the way down to almost my elbow. Small amount of soreness. Dx'd with cellulitis. Y Y 06/15/2001 06/16/2001 1 OTH OTH Multi-vitamins; Synthroid; Vitamin E; Premarin In flood water for 11 hours. Hypothyroidism; Fibrocystic Breast 1
0173885 08/02/2001 KY 41.0 41 M 07/30/2001 Pt returned to clinic on 7/27/01 with red, raised whelps over face, trunk and arms with itching. No respiratory complaints. Used OTC Benadryl and told to go directly to doctor. The doctor Rx'd steroid treatment and continue on Benadryl. Took 1 shot on 6/15/01 and had a rash. Pt related it to something else and did not report it on the next visit. Y Y 07/24/2001 07/25/2001 1 NONE PUB UNK NONE NONE Suspected PCN allergy KY2001052 1
0173858 08/03/2001 TX 0.5 0 .5 F 07/20/2001 Pt had onset of apnea, cyanosis and seizure X 1, 5 days, post vax. Y Y Y 07/10/2001 07/15/2001 5 MRI-nml; EEG X 2-nml PVT OTH NONE NONE NONE ~Vaccine not specified (no brand name)~~0.50~In Sibling 1
0173859 08/03/2001 PA 12.0 12 M 07/27/2001 Pt had muscle weakness in arms and legs and facial muscles. He also had double vision, and trouble walking and could not lift arms, within 10 days of MMR shot. Y Y N 01/04/2001 01/14/2001 10 Blood test; MRI of head & hips; EMG; Muscle biopsy PVT OTH NONE NONE NONE 1
0173860 08/03/2001 IN 10.0 10 M 09/03/2002 Information has been received from a physician concerning a 10 year old male with allergic rhinitis who on 1/30/01, 2/27/01 and 6/19/01 was vaccinated with first (lot# 632556/1985J, in the right arm), second (lot #632556/1985J, in the right arm), and third (lot# not provided, in the left arm) doses of Hep B, respectively. This does not comply with the recommended dose schedule. there was no illness at the time of vaccination. On 2/27/01 the patient experienced a "bizarre" reaction. He began to hallucinate, became fearful, phobic and did not know what was going on around him. He also experienced insomnia, stiffness, and personality change. It was noted that this reaction lasted 6 weeks. ON 7/2/01 the patient, again experienced a "bizarre reaction", hallucinations, insomnia, stiffness, and personality change. Unspecified medical attention was sought. It was reported that the patient recovered from the second reaction on 8/15/01. There were no laboratory tests done. Additional follow-up information was received from the child's parents, on 08/15/02. According to them, the child received the first dose Hep B vaccine recombinant on 1/30/01. Seven to ten days post vaccination, the child began having trouble sleeping at night. He bacame "clingy" about an hour before bedtime and wanted his paretns to sit with him until he fell asleep. He would lay awake for hours waiting for his parents to go to bed and then would go to their room "begging" them to let him sleep in their room. They reported that they did not know what the problem was and that the child had always been a good sleeper. They tried "everything" including reading to him, rubbing his back, and lying with him until he relaxed, but nothing worked. He became more agitated each night. He began to have panic attacks about going to bed. His parents reported that they tried to be firm and force hiim to stay in his own room, but he kept getting more upset. They spoke to the physician, who "pressed" them to keep working on getting the child to sleep in his own bed. He reportedly "assured" them that his sleeplessness could not be associated with his Hep B vaccine recombinant shot. They stated they were also told that there was no side effects from "Hep B shots". They also spoke with the child's teacher who noticed a considerable change in his behavior. She indicated that he was "very edgy and highly strung". His schoolwork began to suffer. The child could hardly keep his eyes open during class. He was only getting 2-3 hours of sleep at night. It was reported that this lasted approximately 2 months and that his parents were starting o see "a bit of improvement" when it was time for the second shot. On 2/27/01, the child received the second dose of Hep B recombinant. Again, about 7-10 days post vaccination, he experienced trouble sleeping. They spoke with the physician, again and he "assured" them it could not be related to the shot. He suggested giving the child melatonin, "an over-the-counter sleep-aid". His paretns gave it to him, but "it didn't help". The child became more agitated. It was reported that he became so terrified and overwrought that his parents "finally had to give in a allow him to sleep with his mom just so the family could get some rest". They hoped that a few nights sleep would help get him back on track. It didn't. Once asleep, he began "sleepwalking" darting from one room to another, up and down the stairs. He experienced nightmares, "big and little syndrome", hallucinations, and convulsions. He spoke out of his mind about things that made no sense. He thought people were after him. He spoke of throwing himself down the stairs and throwing himself in the lake. He also attempted to jump up on the bed and catch the ceiling fan. He ground his teeth and spoke in a low, "evil-sounding" voice about killing his parents and sisters. It was also reported that he complained of being very hot (burning up) and had headache. He complained his head was spinning off and wanted his parents to hold his head on. This would culminate into a convulsion, during which the child would flail and then get very rigid. The convulsions would last about 20 minutes. The child would then get calm and wouldn't remember anything that happened. He complained of having more legs and being cold and clammy when it was over. His parents were so distraught by his behavior that when they would finally fall asleep, the "had to sleep with one eye open" because they were afraid of what he would do to himself or someone else in the family. They arranged for the child to meet with the school counselor. It didnt help. They feared that he was going crazy. They also reported that the child had told them over and over that he thought he was going crazy. Then his parents startd to notice a pattern. Although his behavior, while awake, had changed (he was intense and highly-strung), his severe problems only occurred when he was sleeping. It became obvious to his parents that his trouble falling asleep came about because he was afraid of the nightmares he experienced once he fell asleep. During the daytime, he began complaining of a splitting headache. He would lay down and instantly fall asleep. Within minutes, he began sleepwalking adn talking out of his mind. He said the room was spinning and then the episode escalated into a convulsion. Once the convulsion was over, it would be over until the next time he fell asleep. His parents reported that for weeks, they couldn't let the child play with the neighbors and he wasn't allowed to go on or have "overnights". His parents were afraid of what he might do. During the height of the reaction, his mother had to take time off from work because his parents were afraid to leave him alone with his sisters. Things deteriorated so badly at school, that after several meetings with the principal, his parents decided to change schools in the fall. About two months later, the effects wore off. His parent reported that he started to become the "friendly, happy-go-lucky" kid he had always been. As the weeks went on, he became more confident again. At that time, his parents got the most information out of him, pertaining to what he had been experiencing. On 6/19/01, the child received the third dose of Hep B vaccine recombinant. They questioned the physician about the correlation between the previous shots and the child's problems. They were "assured" that they couldn't be related. About 7-10 days post vaccination, the child experienced the same symptoms. His parents reported that they were "now" positive that the shots were the cause of the child's problems. They spoke to the physician again and he reported the events. Still, they were "assured" that the child's reactions were "unique-nothing similar had ever been reported". The reactions follwing the third dose, were "even more dramatic and terrifying than the previous times". He had such a bad episode at 1:00am that his parents could hardly hold him down. His mother was going to call 911 or get the emergency room doctor whom lives next door, when finally the child started to shake and then got calm. They stat that it was the "worst night of [their] lives, but it was the turning point". Slowly the "effects of the shot" began to wear off. His parents were concerned that he wouldn't be able to start at his new school at the end of August. However, the symptoms began to lift sufficiently by that time and he was able to go to school. His parents reported that they still did not allow him to have any "overnights" for several more weeks, until they were sure that he was totally himself again. They further reported that the reaction were so terrifying to their whole family becasue they were "assured" over and over again that there were no reactions to the "Hep B shots", that they wre safe, and couldn't be related to the child's symptoms. In addition, the child "lost out on months of education, putting him especially behind in math". His parents reported that they worked hard to catch him up with the rest of the class. Upon internal review, the report that the patient's episodes of hallucinations, abnormal behavior, "big and little syndrome", agitation, vertigo, panic attacks, nightmares, mental status changes, headaches, violent thoughts, sleep walking, insomnia, phobia, "convulsions", and feeling hot were determinded to be other important medical events. Additional information has been requested. It has been determined that WAES#0205USA01385 is a duplicate of WAES#01072223. Therefore, WAES#0205USA01385 is being deleted from our files and the reports consolidated into WAES#01072223. (OMIC) Additional follow up info was received from the physician on 8/23/02. He confirmed that following all three doses of hep B vaccine recombinant, the child had bizarre behavior, that he felt was "possibly" related to the vaccine. It was also reported that the child has no medical problems, has not reacted to any other vaccine, and only has allergies such as hay fever. The child is completely normal "now," at the time of report. Y Y 01/30/2001 02/06/2001 7 UNK PVT PVT UNK Hay fever; rhinitis allergic NOS WAES01072223 1
0173862 08/03/2001 CA F 08/01/2001 From telephone contact with pt, it was stated that she received a DT pediatric vaccination in her left deltoid, date not specified. That same day, she experienced a seizure. She was evaluated in ER and discharged. Pt was admitted the following day, to ER, with seizures, treated with Valium and admitted to the hospital. Pt experienced 7 seizures in 4 days. The pt also experienced headache, temperature of 101F, local reaction of redness and swelling at the injection site, weakness and fatigue. Pt had her last tetanus shot 7-8 years ago. This vaccination was a booster; the pt was instructed to have per nursing school. Y Y U CT scan-MRI was neg; EEG and seizure induced EEG-pending UNK UNK U2001009060 1
0173863 08/03/2001 IL 1.4 1 .5 M 08/24/2001 "A physician's MA reported that a 17 month old male received injections of Prevnar (3rd dose), Tripedia, Comvax and IPV on 5/29/01. Almost 1 year, had elapsed since the pt's 2nd Prevnar dose (6/6/00). He was noted to have an ear infection at the time of vaccination on 5/29/01. On 6/6/01 (18 months of age), the pt began to experience fever (99.6F), cough and congestion. He was not treated at that time. On 6/9/01, the pt presented to an ER with a fever and cough and was subsequently admitted to the hospital. A maximum body temperature of 104F occurred (date not specified). The pt was dx'd with Streptococcal pneumonia. He remained hospitalized as of the date of this report (6/12/01)." F/U correspondence rec'd it was reported a MA reported in follow up tha ton 1/12/01 the pt had been discharged from the hospital with a dx of streptococcal pneumonia. The MA stated that the child had been well at the time of the vaccination (conflicts with previously reported info), and had returned to the phycician's office on 7/20/01 for an ear infection.At the time of this follow up, the pt was reported to be doing better. This was originally reported by a physician. Additional info has been requested. F/U states: an 18 month old male with a reactive airway disease and a history of multiple ear infections and 2 dose of haemophilus b conjugate vaccine + Hep-B vaccine recombinant (yeast) in the past, with no adverse events to report, on 6/6/00 (previously reported as 5/29/01), was vaccinated with a 3rd dose of HIB + Hep-B, IM, in the right thigh (lot 637875/1525K); a 3rd injection of Prevnar, IM in the left thigh (lot 473351; 1st injection on 4/11/00, 2nd on 6/6/00 (lots 471215 and 471209), Infanrix-IPV-Hib IM in the left thigh (lot T0485) and Tripedia IM in the right thigh (lot 40357AA). At the time of the vaccination, the pt was noted to have an ear infection. On 6/6/00 (previously reported as 6/6/01), the pt developed a fever (ii.5F), cough and congestion but was not treated at that time. On 6/9/00, the pt presented to an ER with a fever and cough and was hospitalized on that date. The pt's temperature rose to a maximum of 104.0F. The pt was subsequently dx'd with Streptococcal pneumonia. An MA reported in follow-up, that on 6/12/00, the pt had been discharged from the hospital with a dx of streptococcal pneumonia. The MA stated that the child had been well at the time of the vaccination (conflicts with previously reported information), and had returned to the physician's office on 7/20/00 for an ear infection. Subsequently, the pt recovered. This was originally reported by a physician. The streptococcal pnemonia was considered to be life-threatening. F/U correspondence received on 10/29/01 reported, "This pt had pneumonia and pneumococcal bacteremia, 10 days after receiving his 3rd dose of Prevnar. This was not an adverse vaccine reaction=just a failure of vaccine to prevent bacteremia". From follow-up correspondence received from on 11/26/2001, it was reported "The streptococcal pneumonia was considered to be life threatening. Additional information is not expected". Note to file: there have been date discrepancies in follow-up reports received from other manufacturers. A report from one such company does confirm the date of vaccination as that given by the initial reporter. Y 4 N 05/29/2001 06/06/2001 8 Temperature 99.6F on 6/6/01 and 104F 6/?/01 PVT OTH albuterol Ear infection (5/29/01) Multiple otic infection; reactive airway disease; wheezing U2001009030 1
0173864 08/03/2001 DC 33.0 33 M 07/16/2001 One day post vax, the pt developed paresthesia. Four to five months later, he developed joint symptoms. Twelve to thirteen months later, he developed dysequilibrium and a numb sensation. Fourteen to fifteen months later, he developed eye blurring and sleep disturbance. Pt had continued symptoms at evaluation on 7/16/01. Pt recvd first Anthrax vax on 1/5/00, manufacturer Bioport, lot # FAV024, administered in left arm. Y N 04/25/2001 04/26/2001 1 MRI; CSF-consistent with multiple sclerosis MIL MIL NONE NONE NONE 1
0173865 08/03/2001 MA 7.0 7 F 07/30/2001 3-4 hours after vaccine administration on 7/22/01, pt developed large amount of erythema and swelling in entire shoulder, at site of injection, and fever of 101 F; decreased fever overnight with Tylenol and swelling decreased over 2 days. Y 07/23/2001 07/23/2001 0 NONE PUB OTH DDI, Zerit, Nelthnaub, Dramanine, Bactrim HIV positive 1
0173866 08/03/2001 MA F 07/30/2001 Pt had fever after DTAP, IPV, HIB, and PCV7. Y PUB PUB NONE NONE Persistent vomiting 1
0173867 08/03/2001 VA 1.4 1 .3 F 07/17/2001 On 6/20/01 pt started running fever of 102 F; called PMD and they advised to give Tylenol and watch. On 6/21/01 pt was cranky and fever was 102 F. At 1:30 PM started gasping for breath in sleep, started jerking and eyes rolled back in head. Called 911 and ambulance gave O2 and fever was 105 F. ER did blood and urine text and x-rayed chest. Y Y 06/14/2001 06/20/2001 6 Blood and urine and chext x-ray were all normal. PUB PUB NONE NONE Asthma and allergies to cigarette smoke, grass and hay. VA01023 1
0173868 08/03/2001 MD 0.2 0 .2 F 07/31/2001 Pt had fever 101 F and excessive crying. Taken to VHCC ER on 7/26/01 Y Y 07/26/2001 07/26/2001 0 CBC and blood cultures taken in ER-no results given. PVT UNK diverticulum of rectum diverticulum of rectum 1
0173869 08/03/2001 NC 0.4 0 .4 M 07/23/2001 Pt had fever of 103.7 F, a bulging fontanel, irritable, and inconsolable. Y Y 07/12/2001 07/23/2001 11 CBC, Basic Metabolic Panel, UA, urine culture, and blood culture and all were normal. PVT PUB NONE NONE NONE NC01063 1
0173870 08/03/2001 FL 0.5 0 .5 F 07/30/2001 Pt has hives and erythema multiforme after 24 hours of administration . Pt is on Prelone and Benadryl. Y Y 07/26/2001 07/28/2001 2 PVT UNK RX 1 wk for OM NONE 1
0173871 08/03/2001 VA 0.3 0 .3 F 07/27/2001 On 7/19/01 daycare reported to mom that temperature was 104. When mom took temperature it was 101. Pt reluctant to move leg on left side. Mom to give Tylenol for temperature above 100 F and put warm pack on injection site during 1st 24 hours and then a cool pack on site for next day or two. On 7/23 Dad reports child was more comfortable and moving his leg well by late 7/20/01 and now temperature was 98.8 and child was doing fine. Y 07/18/2001 07/19/2001 1 NONE PVT PVT NONE NONE 1
0173872 08/03/2001 NJ F 07/30/2001 After receiving vaccinations pt slept on the way home. Woke up at home and Mom gave her a snack. While eating it mom notiticed moaning, laying her head down frequently and heavy breathing. Felt hot. Vomiting violently and repeatedly. Full body tremors at 30 sec. To ED vomiting repeatedly in minutes. Temperature was 106 in Tylenol given. Baby Kegan acting farily normal Y Y 06/26/2001 06/26/2001 0 PVT PVT Eczema; fever hand hives after 2nda dos amoxil 1
0173873 08/03/2001 CT 40.0 38 M 07/23/2001 No data provided... U 01/17/2000 01/18/2000 1 PVT PVT NONE NONE Allergy to PCN? 1
0173874 08/03/2001 SC 4.0 4 F 07/27/2001 Pt developed a local area at left anterior thigh of redness and induration (2cm X 3cm) firm and tender about 36 hours, post vax. No fever, pain or limp. I prescribed cool compresses and ibuprofen. To reevaluate if worsens but expected to resolve with local care. U 07/25/2001 07/26/2001 1 NONE PVT UNK NONE NONE NONE 1
0173886 08/03/2001 WA 1.0 1 .3 M 07/26/2001 6 days, post vax, pt developed a high fever for 3 days and then a rash on body only. 8 days, post vax, pt had 1 small patch of tiny blister-like rash on stomach. The day after vaccines, the pt's eyes oozed green goo, but felt it might be related to a cold. (Never seen anything like it). Y Y 06/01/2001 06/07/2001 6 MIL UNK Severe cold NONE 1
0173887 08/03/2001 TX 22.0 22 F 07/21/2001 Within 24 hours of 2nd injection, pt had a headache, neck stiffness, sore throat and a fever of 102F with chills and swelling of eye. Y U 06/26/2001 06/27/2001 1 NONE PUB PVT NONE NONE 1
0173888 08/03/2001 VA 23.0 23 M 07/23/2001 Approx. 15:10 on 7/13/01, noted intense itching on back, chest, arms and hives developing soon thereafter. Symptoms treated with Benadryl X 2 on 7/13/01 and X 1 on 7/15/01 and then no further symptoms. Y 07/12/2001 07/13/2001 1 NONE PUB PUB NONE NONE NONE 1
0173889 08/03/2001 MD 18.0 18 M 08/02/2001 Nephrotic Syndrome on prednisone and responding well. Y 07/05/2001 07/13/2001 8 Urine protein 4+; Albumin 1.8; Cholesterol 312 PVT PVT NONE NONE 1
0173891 08/06/2001 75.0 M 08/02/2001 Information has been received from an investigator regarding a 75 year old male who received a dose of influenza virus vaccine trivalent, types A & B, live, cold adapted (frozen formulation) on 12/1/98 as part of the study, "A Randomized, Controlled, Blinded, Multi-Center Trial to Assess the Efficacy of Protection From Natural Influenza Virus Infection of Influenza Virus Vaccine Trivalent, Types A & B, Live, Cold-Adapted (CAIV-T) and Inactivated Influenza Virus Vaccine in Patients With Chronic Obstructive Pulmonary Disease (COPD): A Field Trial". On 12/5/98, the pt developed an exacerbation of chronic obstructive pulmonary disease. He recovered by 12/11/98. The investigator believed that exacerbation of chronic obstructive pulmonary disease (unexpected per the investigator brochure) was "Medically Important" and "possibly" related to study vaccine administration. The medical monitor's assessment is unknown. Follow-up information received on 6/14/01, indicated that the pt received an injection of Fluvirin along with a dose of influenza virus vaccine trivalent, types A & B, live, cold adapted (frozen formulation). On 12/5/98, he developed increased shortness of breath. On 12/8/98, the pt experienced palpitations with exertion. He was seen in an ER where a chest x-ray and an EKG show "no acute changes". The assessment remained unchanged. Additional follow-up received on 8/1/01, indicated that the pt was treated with Augmentin (amoxicillin clavulanate) and prednisone. There was no change in the original assessment. This was a nasal solution. Y 12/01/1998 12/05/1998 4 EKG-no changes; X-ray chest (NOS)-no changes UNK UNK UNK COPD HQ1160422MAY2001 1
0173896 08/06/2001 MA 0.4 0 .4 M 07/30/2001 Infantile spasms: "Salaam Seizures" treated with ACTH-Klonopin. The follow-up states that the child was well up until the vaccinations. Post-vaccination, the parents noted episodes of dropping head forward, extending arms and bringing legs up to chest and it became more frequent 4-5 times a day and tend to occur in clusters so that has 1-3 spasms in one cluster. Other types of seizures head/eye deviation and tonic-clonic. He has also been very irritable and not breast feeding as well as before this incident. Y Y Y 05/29/2001 06/05/2001 7 EEG-hypsarrhythmia, left occipital predominance PVT PUB "Teething at night" Slight gross motor delay 1
0173897 08/06/2001 MN 62.0 62 M 07/28/2001 Started with normal sore shoulder but within days, should got worse (couldn't raise arm), soreness and stiffness spread across shoulder blades, other shoulder then became affected (couldn't get dressed or sleep at night). Then about 2-3 weeks later, spread into neck (much stiffness). I have lived with this for 11 months now and condition is slightly better, but still bad. Doc 204222, 60-Day follow up states that patient seems to be recovering slowly, but still do not have full mobility, still has stiffness in both shoulders, cannot do certain movements like lifting slightly heavy objects. Patient honestly thinks that she is getting better. Y U 08/23/2000 08/27/2000 4 X-rays of shoulders-nml; Muscle wasting test ?-(may not be accurate because of exercise)? MIL UNK Albuterol inhalation; Niacin-2000mg a day (not prescription) Asthma only-given shot with physical 1
0173898 08/06/2001 NC 1.08 1 .1 M 07/25/2001 Right thigh with pink 4-5 cm area. Augmentin and Motrin prescribed. U 07/17/2001 07/19/2001 2 NONE PVT PUB NONE NONE NC01064 1
0173899 08/06/2001 KY 1.0 1 .1 F 07/31/2001 Father reports seizure at home at 4:00 AM, and was taken to Medical Center in Scottsville. Y Y 07/30/2001 07/31/2001 1 Records have been requested from ER visit PUB PUB Duricef Mom reports sore throat around a week ago NONE KY2001054 1
0173900 08/06/2001 NJ 0.2 0 .2 F 08/01/2001 DTAP, HIB, IPV and Prevnar were given on3/30/01 with > 3 hours screaming inconsolable. Y 03/30/2001 03/30/2001 0 NONE PVT UNK NONE 1
0173901 08/06/2001 CA 0.3 0 .3 M 07/27/2001 Pt had erythema, increased in warmth noted on left thigh less than 1 minute after vaccines. Benadryl given po. Y Y 07/27/2001 07/27/2001 0 NONE MIL MIL NONE NONE NONE 1
0173902 08/06/2001 IA 1.0 1 .0 F 07/27/2001 Large area of swelling and redness on left upper leg-onset 7/25/01. Pt evaluated on 7/26/01 at 15:40- 7.0 X 9.0 cm area of erythema, warm and swelling left upper thigh. U 07/24/2001 07/25/2001 1 NONE PVT PVT NONE NONE NONE 1
0173903 08/06/2001 MS 1.0 1 .0 M 07/23/2001 A few vesicle/lesions noted on trunk, legs, arms, face. Positive test result for varicella zoster. U 06/30/2001 07/23/2001 23 positive result for varicella zoster PUB OTH See Q 19 Vent-dependant, hypotonia, cerebral atrophy, genetic, etiology remains unknown. 1
0173904 08/06/2001 CT 57.0 56 M 10/30/2001 Pt developed joint pain after vaccination. This report was received from the pt's spouse and has not been verified by a physician or other health care professional. The vaccinee works as a contractor and is expose to ticks. He reportedly had Lyme disease in 1995, 1996, and 1997. The pt had no adverse experiences following receipt of the first two injections of Lymerix. His spouse reports that she developed Lyme disease after receiving 3 injections of Lymerix. Additional info was received from the treating physician on 10/17/2001. The physician indicated that the vaccinee developed pain in his right shoulder in April 2001. He then experienced pain in his left shoulder. The physician evaluated the vaccinee once for the shoulder pain, on 07/03/2001. No warm or swollen joints were observed on physical examination. No joint fluid was obtained. Erythrocyte sedimentation rate was 5mm/hr., rheumatoid factor was negative, and antinuclear antibody titer was negative. Lyme antibodies by ELISA werre positive at 1.26. Lyme IgM by western blot revealed 39kD and 41kD bands. The physician made a diagnosis of arthralgia and prescribed Celebrax 200mg daily. The physician considered the arthralgia to be mild in intensity and possibly related either to LYMErix administration or exposure to an infected tick. The physician reported thatt the arthralgia persisted as of 07/10/2001. The physician did not confirm the report of headache and fatigue. Y N 09/01/1999 11/01/2000 427 Lyme antibodies by ELISA-1.26; lyme IgM western blot-39kD and 41kD bands present PVT PVT Elevated blood pressure and cholesterol, Lyme disease 3 times, 20010183661 1
0173905 08/06/2001 DE 33.0 33 F Pt appears to be in second or third stage of Lyme disease, numbness and pain in arm or legs, pt has both. She is having severe headaches and neck creaks and cracks with stiffness. Fatigue has worsened to point she can't say awake during public meetings, feels drained. Chills and sweats off and on for a year or more. Muscle and joint pains, shooting pains, burning, tingling and numbness and burning in feet. Feeling light headed and woozy by midday to remaining of day. Left eye twitching and bumping into things from feeling disoriented or perception is off. Reported to friend that I was seeing light spots shooting across room (floater), and restlessness, reoccurring ear pain and sensitive to any thing loud. I have been dx with fibromayalgia. Y N 04/01/1999 07/01/1999 91 There are many attached lab tests and reports. Please see attached forms. PVT PVT Zoloft, allergy meds NONE Allergies, asthma 1
0173906 08/06/2001 DC 26.0 26 M 03/19/2001 Pt c/o left sided facial numbness that persisted for approximately 12 hours. 03/06/2001 03/06/2001 0 NONE MIL MIL NONE NONE NONE 1
0173907 08/06/2001 NC 35.0 32 M 07/28/2001 Pt began experiencing chest discomfort approximately 3 months after 1st anthrax shot. The frequency of the discomfort increased to one a month. In Oct 2000 the severity of the chest discomfort increased. In Dec 2000 the episodes began to include dysphagia and odynophagia, now occurring 2-3 X per day. Pt has lost 25 pounds. N 09/15/1997 12/01/1997 77 Barium swallow on 03/01/2001 abnormal motility of the mid and distal esophagus with decreased peristalsis. EGD on 03/07/2001 results- incomplete relaxation, jack knife type release felt at distal esophagus, and small hiatal hernia. Manometry was normal. PH probe was normal. MIL MIL NONE NONE NONE 1
0173908 08/06/2001 MA 74.0 74 F 07/30/2001 Localized, immediate swelling, heat and pain to forearm. Appearance of greater than 10mm (+) PPD. Y 05/20/2001 05/20/2001 0 NONE OTH OTH PPD (+) NONE 1
0173909 08/06/2001 MA 87.0 86 F 07/30/2001 Localized, immediate swelling, heat and pain to forearm. Appearance of greater than 10mm (+) PPD. Y 05/21/2001 05/21/2001 0 NONE OTH OTH (+) PPD NONE 1
0173910 08/06/2001 WA 2.0 2 .2 M 07/27/2001 10cm-11cm redness and induration on left thigh. Y Y 07/19/2001 07/20/2001 1 PVT UNK NONE NONE NONE Reaction unevaluable~DTaP (no brand name)~3~1.20~In Patient 1
0173911 08/06/2001 PA 12.0 12 M 07/06/2001 Child became dizzy within 5 minutes and collapsed to the ground. Unconscious for 1 minute. Had some jerking movements in both upper extremities, lasting for a minute. Y Y 07/06/2001 07/06/2001 0 CT Scan of head-neg; MRI of brain-neg; EEG-abn-left temporal and frontal swelling PVT PVT Albuterol inhaler; Zyrtec Probable RAD (Reactive Airway Disease); Allergies (allergic rhinitis) 1
0173912 08/06/2001 NY 10.0 10 F 07/30/2001 Pt developed generalized rash with itching and was treated with Benadryl. Y 07/13/2001 07/13/2001 0 PUB PUB Claritin NONE PCN allergy 1
0173913 08/06/2001 MA 78.0 77 F 07/30/2001 Localized, immediate swelling, heat and pain to forearm. Appearance of greater than 10mm (+) PPD. Y 05/20/2001 05/20/2001 0 NONE OTH OTH (+) PPD NONE 1
0173915 08/06/2001 MI 25.0 25 F 07/30/2001 Pt had numbness on left leg X 3 days, muscle fatigue (general) X 7 days and overall physical fatigue X 2 weeks. No treatment given. Y 07/17/2001 07/19/2001 2 NONE PUB OTH NONE NONE NONE 1
0173916 08/06/2001 MI 19.0 19 F 07/31/2001 Pt had a headache, low-grade fever of 99.8F, malaise, "tingling all over" and dizzy. At the area of injection, it was swollen and warm. No treatment except Tylenol and rest. Y 07/19/2001 07/20/2001 1 NONE PUB OTH NONE NONE ASD repair at age of 8 1
0173917 08/06/2001 MA 35.0 35 F 07/30/2001 Localized, immediate swelling, heat and pain to forearm. Appearance of greater than 10mm (+) PPD. Y 05/10/2001 05/10/2001 0 NONE OTH OTH (+) PPD NONE 1
0173918 08/06/2001 MI 2.0 1 .3 F 07/30/2001 Received varivax at health dept on 10/10/00. Broke out with varicella rash on 7/28/01. Seen in ER and dx'd as varicella (for another reason). Y Y 10/10/2000 07/28/2001 291 PUB UNK 1
0173919 08/06/2001 MA 1.25 1 .2 M 07/31/2001 Pt had a fever of 100.5F yesterday, post vax. Today it was 101F and left deltoid had a 6cm erythematous, firm nodule at site of Hib and DTAP. Was told to give pt Benadryl, 1 tsp every 6 hours prn and Tylenol, 1 tsp po prn. Y U 07/30/2001 07/31/2001 1 PVT PUB NONE NONE 1
0173920 08/06/2001 FL 1.7 1 .7 M 08/03/2001 Pt developed swelling of right leg (thigh) area with redness and was also febrile. U 08/01/2001 08/02/2001 1 PVT PUB 1
0173921 08/06/2001 MD 17.0 17 F 07/31/2001 On 7/31/01, pt had pain in upper right arm, down to fingers of right hand with swelling in upper right arm, down to fingers of right hand. This began, post vax, yesterday. Applied ice the evening of 7/30/01 and had less swelling in arm today (7/31/01) but hot and hand still swollen. Referred to PMD for follow-up today. Pt went to ER on 8/1/01, due to hand swelling and states had loss of use of hand and area of hand with decreased blood flow. Calan 40mg Rx given and referred to surgeon. Y N 07/30/2001 07/30/2001 0 PUB UNK NONE 1
0173922 08/06/2001 CT 1.0 1 .0 M 08/02/2001 3 papules with indurated base at site of varivax vaccine on left anterior lateral upper thigh. U 07/23/2001 07/29/2001 6 PVT PUB NONE NONE Small stature 1
0173923 08/06/2001 IL 2.0 2 .4 M 04/16/2001 Pt had swelling of thigh with slight erythematous rash. Y 04/12/2001 04/14/2001 2 PVT PUB IL01026 1
0173924 08/07/2001 FL U 07/30/2001 Information has been received from a woman from a physician's office concerning a pt who on 5/31/00 was vaccinated with pneumococcal vaccine 23 polyvalent (lot 629883/0042J). Subsequently, the pt experienced a temperature of greater that 101F. Unspecified medical attention was sought. Another pt was reported with an adverse event following vaccination with this same vaccine (WAES 00061850). The pt was lost to follow-up. No further information is expected. Y U 05/31/2000 06/01/2000 1 OTH OTH UNK UNK WAES00060352 1
0173925 08/07/2001 WI 74.0 F 07/30/2001 Information has been received from a health care professional concerning a 74 year old female who on 6/13/00 was vaccinated with 1 dose of pneumococcal vaccine 23 polyvalent. In 6/00, the pt experienced redness and warmth at the injection site. The pt sought unspecified medical treatment. On an unspecified date, the pt recovered. No further information is available. Y Y 06/13/2000 PVT PVT UNK UNK WAES00051726 1
0173926 08/07/2001 FL U 07/30/2001 Information has been received from a woman from a physician's office concerning a pt who on 5/31/00 was vaccinated with pneumococcal vaccine 23 polyvalent (lot 629883/0042J). Subsequently, the pt experienced redness, swell and pain at the injection site. Another pt was reported with an adverse event following receipt of the same vaccine (WAES 00060352). The pt was lost to follow-up. No further information is expected. Y U 05/31/2000 OTH OTH UNK UNK WAES00061850 1
0173927 08/07/2001 ID U 07/30/2001 Information has been received from a healthcare facility concerning an unidentified pt who was vaccinated with pneumococcal vaccine 23 polyvalent (lot 633102/1217J). Subsequently, the pt experienced shoulder and elbow pain. The pt sough unspecified medical attention. An additional pt (WAES 00062102) had a similar experience following exposure to this same vaccine. Additional information has been requested. Y U OTH OTH UNK UNK WAES00061872 1
0173928 08/07/2001 ME U 07/30/2001 Information has been requested from a healthcare professional concerning a pt who on approx. 6/9/00 was vaccinated with 1 dose of pneumococcal vaccine 23 polyvalent (lot 633103/1216J). Subsequently, the pt experienced cellulitis at the injection site that extended all the way down the arm. The pt was treated with antibiotics in the ER but not admitted. Another pt (WAES 00062248) had a similar experience. Additional information has been requested. Y U 06/09/2000 06/09/2000 0 UNK UNK UNK UNK WAES00061885 1
0173929 08/07/2001 ME 66.0 66 F 07/30/2001 Information has been received from a physician concerning a 66 year old white female with a history of a (+) PPD tuberculosis test, a seizure disorder and hyperlipidemia who on 6/14/00 was vaccinated, IM, with a 1st dose of pneumococcal vaccine 23 polyvalent (lot 633103/1216J) in the right deltoid. Subsequently, the pt developed extensive edema and erythema in her right arm, malaise and myalgia. A dx of injection site cellulitis was determined. The pt was treated with rest, analgesics and oral cephalexin (Keflex). On 6/27/00, the pt recovered. It was also noted that another pt (WAES 00071379) experienced a similar reaction after vaccination with this same vaccine. No further information is available. Y Y 06/14/2000 PVT PVT UNK PPD tuberculosis test (+); hyperlipidemia; seizure disorder WAES00061903 1
0173930 08/07/2001 ID U 07/30/2001 Information has been received from a healthcare facility concerning an unidentified pt who was vaccinated with pneumococcal vaccine 23 polyvalent (lot 633102/1217J). Subsequently, the pt experienced shoulder and elbow pain. The pt sought unspecified medical attention. An additional pt (WAES 00061872) had a similar experience following exposure to the same vaccine. Additional information has been requested. Y U OTH OTH UNK UNK WAES00082102 1
0173931 08/07/2001 ME U 07/30/2001 Information has been received from a healthcare professional concerning a pt who was vaccinated with 1 dose of pneumococcal vaccine 23 polyvalent (lot 633103/1216J). Subsequently, the pt experienced cellulitis at the injection site that extended all the way down the arm. The pt was seen in the physician's office for examination and treated with antibiotics. It was noted that the pt was afebrile. Another pt (WAES 00061885) had a similar experience. Additional information has been requested. Y U OTH OTH UNK UNK WAES00062248 1
0173932 08/07/2001 PA 69.0 M 07/30/2001 Information has been received from a healthcare professional concerning a 69 year old male who in 6/00 was vaccinated with 1 dose of pneumococcal vaccine 23 polyvalent. It was noted that the pt was schedules for surgery in 6/00 and that routine blood work revealed "anti-D (anti-RBC) antibodies". The pt did receive gamma-globulin. Additional information has been requested. Y U 06/01/2000 06/01/2000 0 Diagnostic lab 6/00-anti-D (anti-RBC) antibodies OTH OTH Gamma-globulin UNK WAES00082385 1
0173933 08/07/2001 PA 32.0 32 F 07/30/2001 Around 8 PM post vaccination, the pt developed a large, local, red, warm, area at the injection site which spread from the upper arm to her elbow. The physician also added that the subcutaneous tissue is indurated to a size of 16 cm X 30 cm if spread out and there is no fever or lymphadenitis. The pt sought unspecified medical attention. Additional information has been requested. Y U 06/20/2000 06/20/2000 0 OTH OTH UNK UNK WAES00062979 1
0173934 08/07/2001 MN 18.0 18 F 07/30/2001 The day after vaccination, the pt woke up with a two inch diameter lump in the injection site area. The pt experienced itching and was nauseated the entire day. The nausea resolved by the next evening and the itching continued for the 2 or 3 days post vaccination. The pt is recovered and did not experience any other symptoms or rxn's. Y 05/16/2000 05/17/2000 1 PVT PVT UNK UNK WAES00070168 1
0173935 08/07/2001 WI 24.0 24 F 10/08/2002 Information has been received from a registered nurse concerning a 24 year old female patient with no known allergies who on 04/09/00 was vaccinated in the left deltoid with the first dose of pneumococcal vaccine 23 polyvalent (lot #630097/0045J)/ On 04/24/00, the patient experienced a severe local reaction in the left deltoid region. It was noted that the estimated area was approximately 4-5 cm and warm and firm,but not fluctant. The patient's temperature was 99.5 degrees fahrenheit and she had been taking Tylenol. On an unspecified date,the patient recovered. Two other patients (WAES numbers 00051264 & 00070168) had similar experiences. No furhter information is available. Y Y 04/21/2000 04/24/2000 3 Body Temo - 04/24/00 - 99.5 F PVT PVT UNK NKA WAES00070640 1
0173938 08/07/2001 0.75 M 08/03/2001 Information has been received on 7/16/01 from an internet site through a consumer, concerning a 9 month old male who received his 3rd dose of DTP on 8/22/84. He immediately began vomiting. The next day, he stopped eating. He reportedly, stayed alert but was no longer active. That night, he cried out every 15 to 30 minutes. He was seen in the pediatrician's office where the pediatrician immediately noted "obvious circulation collapse". His eyes rolled back in his head an he stopped breathing. He was taken to an ER. Resuscitative efforts failed and he was pronounced dead. Y 08/23/1984 Y N 08/22/1984 08/23/1984 1 UNK OTH OTH UNK UNK UNK HQ4000102AUG2001 1
0173944 08/07/2001 MD 5.0 5 M 08/01/2001 Information has been received from a health professional concerning a pt who was vaccinated with MMRII and subsequently, the pt experienced an anaphylactic reaction. No further information was available. Upon internal review, anaphylactic reaction was considered to be an "Other Important Medical Event". Additional information has been requested. F/U states: Information has been received from a health professional concerning a 5 year old Caucasian male pt who, on 5/1/01, at 13:00, was vaccinated in the right arm with a 2nd dose of MMRII (lot 0168L-invalid lot). The pt returned to the office about 1/2 hour, after the injection, complaining of wheezing and covered with hives, consistent with an anaphylactic reaction. The pt was treated with albuterol nebulizer, antihistamines and epinephrine. It was noted that the pt recovered on 5/1/01. Upon internal review, anaphylactic reaction was considered to be an "Other Important Medical Event". Additional information has been requested. Y Y 05/01/2001 05/01/2001 0 PVT PVT UNK UNK WAES01071675 1
0173946 08/07/2001 65.0 M 02/21/2002 Information has been received from an RN concerning a 90 year-old male assisted living pt with Alzheimer'd disease, cardiac problems and no known allergies and a history of atrial fibrillation and dementia who on 7/16/01 was vaccinated IM on the right deltoid with a 0.5 ml dose of pneumococcal vaccine 23 polyvalent. On 7/17/01, the pt was found unresponsive and bradycardic on the bathroom floor at the assisted living facility. The pt was transferred to the ER. In the ER, it was noted that the pt's right arm was red, swollen and warm to touch. The pt was treated for cellulitis with IV amoxicillin trihydrate (+) clavulanate potassium (Augmentin). He was admitted to the hospital for his cardiac condition and was discharged from the hospital on 7/23/01 to a nursing home facility. The nurse reported that the pt's unresponsiveness was not related to the pneumococcal vaccine 23 polyvalent, it was related to his cardiac problems. The pt was discharged on PO amoxicillin trihydrate (+) clavulanate potassium (Augmentin) and it was noted that his arm swelling had greatly improved. The reporter expressed a concern with the lot. The records of testing prior to release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released. It was reported that another pt (WAES 01072423) had a similar experience following exposure to pneumococcal vaccine 23 polyvalent (lot 637369/1187K). FOLLOW-UP information indicated that the pt was hospitalized for five days and subsequently, recovered. Upon internal medical review, the pt's cellulitis was considered to be another important medical event. Additional information has been requested. Y Y 6 N 07/16/2001 07/17/2001 1 OTH OTH UNK Atrial fibrillation; Alzheimer's Disease; Cardiac disorder WAES01071828 1
0173947 08/07/2001 UT 5.0 M 08/02/2001 Information has been received from an MA concerning a 5 year old male who on 7/17/01 was vaccinated with a 1st dose in the left leg of varicella virus vaccine live and a 1st dose, in the left leg, of diphtheria toxoid/pertussis vaccine/tetanus. There were no other concomitant medications. That night, the pt's leg became very swollen and stiff and he was unable to bend it. He went to the ER on 6/18/01 and they did a tap on the knee to make sure that there was no bacteria in the knee. The cultures were reported as negative. It was noted that the pt did not stay overnight at the hospital. The pt was seen in the doctor's office on 7/19/01 and seemed better and on 7/20/01, the day of this report, the pt was seen again in the physician's office. The swelling had gone down slightly, however, it was still swollen and he was still unable to bend his knee. The physician recommended continuing treatment with ibuprofen. The reporter stated that the lower extremity edema and muscular-skeletal stiffness was a reaction to the varicella virus vaccine live and the diphtheria toxoid/pertussis vaccine/tetanus. Follow-up information from a nurse, indicated that the pt reported to his mother that he had fallen on the left leg around the same time as the vaccination. It was reported that the swelling and stiffness were "documented to be probably related to the Varivax administration". The nurse indicated that the office has not heard from the pt's mother and they are "assuming the child is OK". Upon internal review, the pt's experience was considered an "Other Important Medical Event". Additional information has been requested. Y U 07/17/2001 07/18/2001 1 Diagnostic microbiology 7/18/01-culture from knee tap was neg OTH OTH WAES01072150 1
0173948 08/07/2001 FL 65.0 F 08/02/2001 Information has been received from a health professional concerning a female assisted living pt over the age of 65 who on 7/16/01 was vaccinated, IM, with a 0.5 ml dose of pneumococcal vaccine 23 polyvalent (lot 637369/1187K). On 7/18/01, the pt was taken to the ER for cellulitis with symptoms of swelling, redness and a warm to touch arm from the site of the injection down to her fingers. She was treated with IV ceftriaxone sodium (Rocephin) and was released back to the assisted living facility, hospital admission was not needed. It was reported that the pt has subsequently recovered. The reporter expressed a concern with the lot. It was reported that another pt (WAES 0107128) had a similar experience following exposure to pneumococcal vaccine 23 polyvalent (lot 637369/1187K). Upon internal medical review, the pt's cellulitis was considered to be an "Other Important Medical Event". Additional information has been requested. Y Y 07/16/2001 07/18/2001 2 OTH OTH UNK UNK WAES01072423 1
0173950 08/07/2001 FL 50.0 50 F 07/30/2001 A 50 year old female student, attending a veterinary school of medicine, who was being treated for pre-exposure prophylaxis, developed diffuse pain on the entire left arm which resulted in a tingling sensation and paresthesia, 24 hours, post vax, of a 2nd pre-exposure dose of RabAvert. Each dose was 1ml and given IM. (Batch 277011). The 1st dose of RabAvert was on 7/3/01 and the 2nd was on 7/10/01. The pt continued to have left shoulder pain, joint pain, finger joint pain, left-sided neck pain, and is tender to touch on the left side of the body. There was no erythema at the injection site. A neurologic work-up was normal and the pt was afebrile. The pt complained of a headache, 3 days, post vax of the 2nd dose. It was reported by the PA, that as of 7/23/01, the condition of the pt was improving. The PA assessed this event as possibly related to the RabAvert injection. N 07/10/2001 07/11/2001 1 PUB OTH NONE UNK Allergy to sulfonamides EM20010908 1
0173951 08/07/2001 IA 75.0 75 M 07/30/2001 Information has been received from an MA concerning a 75 year old white male who on 12/5/00 was vaccinated, IM, with pneumococcal vaccine 23 polyvalent (lot 637094/0945K). Subsequently, on 12/6/00, the pt experienced increased swelling and erythema of the upper arm that was considered an "Other Medical Event". Subsequently, the pt recovered "spontaneously". This was the pt's booster dose. The pt had no reaction with previous dose. Unspecified medical attention was sought. No further information is not expected. Y Y 12/05/2000 12/06/2000 1 PVT PVT UNK UNK WAES00121114 1
0173952 08/07/2001 NC 7.0 7 M 07/30/2001 Information has been received from a consumer concerning her 7 year old son who on 10/24/00 was vaccinated with the 2nd dose of pneumococcal vaccine 23 polyvalent. Within 6 hours, post vax, the child's injection site arm swelled from his elbow to his shoulder to 3 times it's normal size. He also developed a fever of 103F. The fever "went down" as of 20:00 on 10/25/00. The child was seen by a physician who put him on a steroid and an antihistamine. It was noted as of 10/26/00, the child still has pain and swelling in his arm. Upon medical review, the pt's experiences were considered to be "Other Medical Events". No further information is available. Y N 10/24/2000 10/24/2000 0 OTH OTH Claritin Hayfever; pneumonia in 8/00 WAES00102330 1
0173954 08/07/2001 HI 28.0 28 M 08/03/2001 This report was received as part of workman's compensation and litigation proceedings. On 1/23/97, the pt sustained a needle puncture injury to his palate while eating. According to a computed tomogram and an otorhino-laryngologist's evaluation, the needle did not pierce the hard palate. Treatment of the injury included flushing the wound with diluted Cepacol mouthwash. On 1/23/97, the pt received Engerix-B and Hep-B immune globulin, tetanus toxoid, and zidovudine (Retrovir). Three days later,on 01/26/1997, he experienced swelling and numbness around the site of injury. The patient took an anti-inflammatory medication and the swelling resolved. Evaluation revealed only unspecified sinusitis, which was judged to be unrelated to the injury. Treatment and outcome of the sinusitis was not provided. On approx. 6/15/97, 144 days, post vax, the pt presented with generalized urticaria. Diagnostic evaluation reportedly revealed elevated serum IgE concentration and excluded a 01-inhibitor deficiency. The pt received unspecified treatment. Intermittent episodes of urticaria persisted and a dx of recurrent benign urticaria was made. The pt is reportedly claiming disability on the basis of the urticaria. CT of the sinuses performed 02/21/1997 demonstrated left sphenoid, bilateral ethmoid, and bilateral maxillary sinusitis. The patient was treated with Augmentin for 2 weeks. The pt was seen by his primary physician on 02/27/1997 complaining of coughing and nasal congestion for 2 weeks, spitting out mucus, and swelling of the right eye. The sinusitis was judged to be unrelated to the injury and resolved. On 06/15/1997, 144 days post-immunization, the pt presented to the ER with swelling of his face and eyes, and numbness of the left side of his face. The ER physician prescribed Ceclor and Entex-LA. The vaccinee was seen by an ENT specialist on 06/16/1997. The specialist prescribed Augmentin. The pt was referred to an allergist. The allergist made a diagnosis of idiopathic induces angioedema. The patient was then symptom free until 09/97, when he experienced swelling that occurred rapidly and involved his throat. He also experienced difficulty breathing. He was taken to the local ER and teated with an injection of epinephrine and given a prescription for a prefilled epinephrine syringe, to use as necessary. The frequency and severity of episodes of hives, facial swelling, and left facial numbness increased and the pt was referred to an allergist. The pt was prescribed Allegra. The episodes of swelling persisted. Allegra was discontinued and replaced with Claritin. This also did not work, so treatment was changed to Zyrtec. Then a combination of Claritin in the AM and Zyrtec in the PM was prescribed. The hives persisted, so Atarax was added to the regimen. The pt was seen by a 2nd allergist on 05/17/1999, again with a flare-up of swelling on his face, probably secondary to a virus infection. The pt had only slight symptoms of respiratory infection. The patient was next seen on 06/01/1999 with marked swelling of his forehead and face. On 06/26/1999 the pt became very dyspneic and had yellow sputum. The pt presented to the allergist on 06/28/1999 with swelling of the face and eyes. The diagnosis was acute bronchitis, asthma, and angioedema of the left side of the face. The pt was treated with antihistamine eye drops, Beclovent inhaler, Albuterol inhaler, and azithromycin. The pt visited the allergist on 04/11/2000 and reported that he continued to experience "outbreaks of swelling which have been becoming more frequent". The allergist noted that the pt had episodes of angioedema of the eyelids. The pt had some wheezing the evening of 04/10/2000. The allergist added Singulair to the other medications the pt was taking. On 05/23/2000 the patient was seen by a 3rd allergist. The pt reported his main concerns to be 'large bulbous swellings throughout his facial area and nowhere else. The pt reported that he developed 4 to 6 episodes of hives per month; he categorized two or three episodes per month as 'severe' and the rest were mild-to-moderate. The hives always occurred only on the head and face. The pt experienced headaches on rare occasions. Upon examination, there was 1cm in diameter macule on the right side of the upper lip. The pt presented to the ER on 07/27/2000 with angioedema of the lip without any other symptoms. He underwent the usual treatments and sent home. He was seen by the 2nd allergist on 07/28/2000. The allergist prescribed prednisone and increased the Allegra dosage. The patient again presented to the ER on 08/24/2000 with right facial and periorbital swelling. His tongue was slightly increased in size but he had no difficulty breathing or swallowing. The pt was treated with Bicillin-LA. The next day he was seen by the 2nd allergist, who prescribed penicillin VK. The patient returned to the ER on 11/28/2000 with itching of his hands, swelling of his hands, facial swelling, and an itchy throat. The pt was seen by a 4th allergist on 03/29/2001. This allergist stated, "the correct diagnosis is angioedema following immunization for Hepatitis B and the use of HBIG in a patient with long standing liver disease. His current medical condition is a reaction to the immunization that he received and his underlying liver disease". The pt is reportedly claiming disability on the basis of the urticaria. Y Y N 01/23/1997 06/15/1997 143 Serum IgE-elevated OTH OTH Hep-B immune globulin on 1/23/97 Multiple allergies NOS; needle puncture injury to the palate; he worked as a corrections officer. Allergic reaction to yellow jackets, 1977; allergic reaction to unspecified food, 1978; allergy to blue mussel, cantaloupe, and 2 types of housedust mites; hypertention, 1985; hepatocellular hepatitis, 1986; keratoconus of the right eye, 1989 with subsequent corneal transplant, 1992; gout, 1993; anxiety, 1996; chest pain, 1996; and unspecified problems with anger management. 20010185171 1
0173957 08/07/2001 PA 4.0 4 M 07/25/2001 Fever, staring spells, listless. 9/16/93, adverse reaction began within 1 hour of injection. Pt did not speak for 10 days and was lethargic. Required a visit to his pediatrician and pediatric neurologist. Permanent disability. Y Y N 09/16/1993 09/16/1993 0 MRI and EEG's PVT PVT PDD/Mild autism Fever and stares~DTaP (no brand name)~4~1.00~In Patient 1
0173958 08/07/2001 CA 47.0 47 M 07/26/2001 Not reported to doctor until last immunization; arthralgia, muscle atrophy, tremor, Parkinson's. Slow to onset, 2 days, post injection of opposite sides arthralgia and declined progress to neuro specialist. Sees rheumotologist and neurologist. Y N 09/22/1999 09/25/1999 3 EMG testing-physical changes PVT PVT Arthrinol; Cytotec Psoriatic arthritis Psoriatic arthritis only 1
0173959 08/07/2001 CA 4.75 4 M 07/27/2001 Approx. 15:00 on 7/26/01, pt developed swelling of eyes, lips, nose and sneezing. Within 15 minutes, hives appeared on face, arms, feet and wheezing by auscultation. Symptoms occurred within 10 minutes of receiving injections. At 15:20, pt was treated with Benadryl 25mg and Decadron 10mg, IM. The follow-up states "back to normal" on 07/27/2001 by mom. No hives, no swelling, appetite good so may stop Benadryl. Y Y Y 07/26/2001 07/26/2001 0 PVT PVT NONE NONE 1
0173960 08/07/2001 WI 0.4 0 .5 F 05/31/2001 Low-grade fever on 5/25/01. Subsequently, hospitalized. On 5/29/01, dx'd with strep pneumoniae Meningitis and bilateral otitis media. Rx'd with cefotaxime 500mg; Vancomycin 100mg. Transferred to another hospital on 5/29/01, due to seizures. Continues to be hospitalized. On 6/20/01, now discharged from hospital. Y Y 05/18/2001 05/25/2001 7 CSF done and blood culture also strep pneumoniae PUB PUB NONE WI0126 1
0173961 08/07/2001 WI 1.0 1 .0 F 07/20/2001 On 07/13/2001 in the AM the patient developed small dots on her stomach, which worsened in the PM. On 07/14/2001 the rash spread to her face with swelling. The patient was seen in the ER and was given a shot to stop the swelling. The patient was then treated with Cortisone and Benadryl. The rash was raised like hives. The patient improved after treatment at the ER. Y Y 07/12/2001 07/13/2001 1 PUB PUB Iron Supplement NONE Anemia WI0127 1
0173962 08/07/2001 NY 1.0 1 .0 F 07/28/2001 The patient developed vomiting and gagging several hours after vaccination. Y 07/26/2001 07/26/2001 0 NONE PVT PVT Polyviflor Fever 2 days prior, none within 24 hours NONE 1
0173963 08/07/2001 NY 1.0 1 .0 F 07/28/2001 The patient developed vomiting approximately 2 hours after vaccination and intermittently the next 6-8 hours, then intermittent gagging. The patient had no fever and was instructed to keep fluids down. There was a similar reaction with all triplets. Y 07/26/2001 07/26/2001 0 NONE PVT PVT Polyviflor NONE Resolved GER 1
0173964 08/07/2001 NY 1.0 1 .0 F 07/28/2001 The patient experienced vomiting and gagging several hours after vaccination. The patient was gagging intermittently for approximately 24 hours. All triplets had the same reaction. Y 07/26/2001 07/26/2001 0 NONE PVT PVT Polyviflor NONE Benign megancephaly 1
0173965 08/07/2001 MI 0.3 0 .3 F 07/05/2001 The patient developed urticaria approximately 18 hours after vaccination. The patient developed large raised hives around the neck, on the chest, abdomen and in the perineal upper thigh diaper area. The patient was seen in the ER and given an injection of Phenergan. 24 hours later the hives were less and had moved to the arms and legs. The patient was in no distress. Y Y 07/02/2001 07/03/2001 1 PUB PUB NONE NONE MI2001055 1
0173966 08/07/2001 AL 1.08 1 .1 F 08/02/2001 The patient developed a morbilliform rash. Y U 07/16/2001 07/25/2001 9 NONE PUB PUB PPD NONE NONE 1
0173967 08/07/2001 IL 0.5 0 .5 M 08/01/2001 The patient experienced a 3 minute episode of muscular tonic clonic movement, cyanosis and starring the morning after vaccination. The patient was referred to a pediatric neurologist. Y Y 07/30/2001 07/31/2001 1 PVT PUB NONE NONE NONE 1
0173968 08/07/2001 HI 1.08 1 .1 M 07/27/2001 The patient developed a fever of 104F, irritability and a small red papular rash on his face a few hours after the vaccines were given. U 07/26/2001 07/26/2001 0 PVT PVT NONE NONE NONE 1
0173969 08/07/2001 MN 2.0 F 07/27/2001 Post vax, the patient developed 57 x 50 mm erythema around the site and a 20 x 26 mm induration 48 hours after the injection. Y 07/25/2001 07/27/2001 2 PVT PVT NONE NONE NONE 1
0173970 08/07/2001 WI 0.5 0 .5 F 05/18/2001 Post vax the patient developed a fever of 102.4F. The patient was treated with Tylenol and the fever dropped to 101F. The patient was fussy, sleeping more, and not eating well. A macular rash on the back and neck were noticed on 05/17/2001. The fever lasted until the evening of 05/17/2001. Y Y 05/15/2001 05/15/2001 0 PUB PUB NONE NONE NONE WI0124 1
0173971 08/07/2001 CO 1.08 1 .1 M 07/30/2001 The patient developed a lesion the first day post vax. The patient developed several more on ensuing days. The most severe lesions were on his toes and were vesicular in nature with oozing of serous fluid. The patient was seen by his primary care physician on 07/30/2001. Y Y 07/25/2001 07/26/2001 1 NONE PUB PUB NONE NONE 1
0173972 08/07/2001 NY 49.0 49 F 07/31/2001 The patient developed right upper extremity joint pain approximately 5 months after the 1st injection. Pain has progressed to most body joints with stiffness and swelling. The patient has been advised by a physician that the symptoms are arthritic and most likely a complication on the vaccine. The patient is receiving anti-arthritic medication as prescribed by the doctor. Y N 04/13/1999 HLA-Dry Test=positive PVT PVT Oral Medications for diabetes NONE Type II diabetes 1
0173973 08/07/2001 NJ 30.0 29 F 07/24/2001 The patient experienced LLR after the 2nd anthrax dose. This occurred 4-5 days later and lasted 10 days. Y 05/21/2001 MIL MIL PTU NONE NONE 1
0173974 08/07/2001 MT U Post vax the patient developed severe back pain, weakness and was tired. These symptoms progressed as the day went on accompanied by chills and a headache. The patient was advised to seek medical attention. U 07/13/2001 07/13/2001 0 PUB PVT Wellbutrin, Axid, Levoxyl, Neurontin, Serozone, Estradiol NONE NONE MT0108 1
0173975 08/07/2001 WI 0.2 0 .2 M 07/27/2001 The patient became very limp on 05/30/2000 hours after receiving the two vaccines. The patient stopped rolling over and lifting his head, which he had been doing. He now has hypotonia and delays in fine motor, gross motor and speech. Y N 05/30/2000 05/30/2000 0 PVT PVT NONE NONE NONE 1
0173976 08/07/2001 MA 25.0 25 F The patient developed a small rash on her back within 24 hours of vaccination. This was not reported for 1 month. U 05/23/2001 05/24/2001 1 NONE UNK UNK Allergy to PCN 1
0173977 08/07/2001 WI 0.48 0 .5 M 07/30/2001 The patient developed a high fever, body aches, and inconsolable crying the next day after vaccination. A few days later the patient developed constipation. All symptoms ended in approximately 1 week except for the constipation, which continues. Y N 07/31/1998 08/06/1998 6 NONE PVT OTH NONE NONE NONE 1
0173978 08/07/2001 TX 4.0 4 F 07/27/2001 Post vax, the patient was playing but complained that her arm was sore. She also had a temperature of 101F. Y 07/25/2001 07/27/2001 2 PUB PVT NONE NONE NONE 1
0173979 08/07/2001 PA 27.0 27 F 07/31/2001 Post vax the patient experienced urticaria and angioedema of the hand and thumb. Y 07/30/2001 07/31/2001 1 NONE OTH OTH OCP-Orthocycline NONE Allergy - PCN 1
0173980 08/07/2001 MN 5.0 5 F 07/17/2001 The patient developed one large hive at the injection site in her upper left thigh. The hive developed to the size of a grapefruit. This began the same day as the vaccination and continued through 06/19/2001. No treatment was given. Y Y 06/15/2001 06/15/2001 0 PVT OTH Vitamin w/fluoride NONE NONE 1
0173981 08/07/2001 IL 5.0 5 M 07/30/2001 The patient complained of pain in his left arm. The mother saw swelling and redness. The arm is painful to touch and hard. One half of the left upper arm is involved. The patient was treated with Motrin and started to improve. Y 07/27/2001 07/29/2001 2 PVT PVT NONE ~Measles + Mumps + Rubella (MMR II)~1~1.00~Patient 1
0173982 08/07/2001 MA 29.0 28 F 07/30/2001 The patient experienced immediate localized swelling, heat and pain to the forearm. There was the appearance of greater than 10mm + PPD. Y 06/02/2001 06/02/2001 0 NONE OTH OTH NONE 1
0173983 08/07/2001 WI 1.0 1 .0 F 05/25/2001 On 04/28/2001 the patient developed a fever of up to 103.5F. The patient was treated with Tylenol or Motrin. The temperature would drop to 99.5-100F and then return back to 103F within 4-6 hours. On 04/29/2001 the mother notes a few spots and on 04/30/2001 had a generalized rash over the trunk and face. On 04/30/2001 the patient presented to a doctor for evaluation. The fever persisted through 04/30/2001. The rash resolved after a couple of days. Y Y 04/18/2001 04/28/2001 10 PUB PUB NONE NONE ~Measles + Mumps + Rubella (MMR II)~1~0.00~In Sibling WI0125 1
0173984 08/07/2001 WI 54.0 54 F 04/26/2001 The patient developed a rash at the injection site which spread over several days to her neck, throat, chest and back. Two to three days later, the patient felt cold and her BP was lower than usual, 101/50. The patient developed a sinus infection 4-5 days after the injection. The patient was treated with an antibiotic. Y 04/09/2001 04/09/2001 0 OTH PUB NONE Penicillin Rash~Influenza (Seasonal) (no brand name)~1~49.00~In Patient WI0123 1
0173985 08/07/2001 MN 5.0 5 M 07/29/2001 Post vax the patient developed localized erythema and central induration. Y Y 07/27/2001 07/28/2001 1 NONE PVT PVT Claritin NONE Allergic rhinitis 1
0173987 08/07/2001 MT 1.4 1 .4 M 06/21/2001 On 06/19/2001 the patient experienced a slightly swollen leg with a red bump, approximately dime size, at the injection site. The patient's mother stated his leg had been more swollen and was very warm the first 3-4 days after the shot. The patient would fuss and pull his leg away when anyone tried to touch it. Y 06/14/2001 PUB OTH NONE NONE NONE MT0111 1
0173988 08/07/2001 MT 48.0 48 F 07/18/2001 On 07/13/2001 the patient experienced joint pain in right knee. Joint pain increased along with redness and swelling and extended to left knee, wrist and hands and the patient could hardly walk. The patient was treated with ibuprofen, ice, heat and rest. At the time of acute symptoms the patient reported her hand grip was about 20%. Feels much better today, 07/18/2001 and reports her hand grip at 90%. The patient is recovering. Y 06/29/2001 07/13/2001 14 PUB PUB Estrogen (Provera and Orthoest) NONE Had polio at age 8; left arm and left side of back slightly atrophied MT0109 1
0173989 08/07/2001 MI 1.5 1 .3 F 07/13/2001 Seizure 9 days after immunizations. No fever or other illness at time. On 10th day child peppered with rash over entire body with was gone the following day. Y Y 06/20/2001 06/29/2001 9 PUB PUB NONE NONE NONE MI2001054 1
0173990 08/07/2001 MI 5.0 5 M 07/13/2001 On 07/11/2001 the patient experienced a runny nose, fever of 101-102F. Night terrors started on 07/10/2001. The patients joints, arms, sometimes legs and hands were tingling. The patient doesn't want anyone to touch him. N 07/05/2001 07/10/2001 5 NONE PVT OTH NONE 1
0173991 08/07/2001 CA 15.0 15 M 07/25/2001 The patient began itching all over especially his chest, back and hands. There was no rash or swelling noted by the mother. There was no redness or swelling at the injection site. The patient denies headache, fever, nausea, vomiting, diarrhea, etc. The patient had Lidocaine with an ingrown toenail removed on 07/23/2001. Y 07/24/2001 07/25/2001 1 NONE PUB PUB Lidocaine NONE NONE CA010081 1
0173992 08/07/2001 NJ 1.0 1 .0 F 08/01/2001 On 07/23/2001 the patient's eye was swelling and the patient was treated with Benadryl. The patient had hives all over as of 07/29/2001. Some of the hive looked like papules. N 07/21/2001 07/23/2001 2 NONE PVT PVT NONE NONE Seborrheic Dermatitis 1
0173993 08/07/2001 VA 18.0 18 M 07/19/2001 Post vax, the patient experienced dizziness that lasted 3 weeks. The patient was diagnosed with vertigo, no fever. Possible contributing factors are the patient was in a soccer game on 06/19/2001 or 06/21/2001 and was hit at the ear area and had a "bump". Also, 9-10 days before the vaccine, the patient swam in the ocean with a high bacteria level. Y 06/22/2001 06/24/2001 2 PUB PUB NONE NONE VA01024 1
0173994 08/07/2001 VA 1.25 1 .3 M 07/17/2001 The day after vaccines, while swinging, the family noticed the patient had a fixed gaze and seemed to be not focusing on objects for more than 10 minutes. He has had none since. Y 04/02/2001 04/03/2001 1 EEG and Head CT were normal PVT PVT NONE 1
0173995 08/07/2001 MA 71.0 71 F 08/02/2001 The patient developed redness and warmth in a 5cm area at the injection site six days after the vaccine was given. Y 07/25/2001 08/01/2001 7 PVT PUB Avapro, Verapamil, Aspirin, Multivitamin NONE Hypertension, seasonal allergies, DVT in past 1
0173996 08/07/2001 GA 4.5 4 F 07/31/2001 On 07/27/2001 the patient developed a local reaction at the injection site. The reaction lasted more than 48 hours. The patient complained of pain, tenderness, swelling and redness. The area of reaction was more than 3 inches. Y 07/25/2001 07/27/2001 2 NONE PVT PVT NONE NONE NONE 1
0173997 08/07/2001 IN 12.0 12 M 08/12/2001 Per mother on 07/28/2001 the patient experienced facial swelling in front of and under his ears to his upper neck and going to his eyes. The patient was seen in the ER. The swelling lasted 1-2 days. Y Y 07/12/2001 07/28/2001 16 CBC, lymphs, EOS, RBC and Hgb, Amylase, serum PUB PUB NONE NONE 1
0173998 08/07/2001 PA 1.0 1 .0 F 07/20/2001 Post vax, the patient developed on her left cheek, a macula papular zoster in a less than 1 inch patch. The patient was being treated for an ear infection at the same time. Y 04/19/1999 02/23/2001 676 NONE PVT PUB PA0153 1
0173999 08/07/2001 MI 60.0 F 07/30/2001 Post vaccination the pt experienced swelling, redness and itching at the injection site and slightly systemically. the symptoms were relieved by Benadryl, but as of 07/12/00 were still present. Additional information has been requested. Y N 06/26/2000 OTH OTH UNK UNK WAES00070992 1
0174000 08/07/2001 NY 20.0 F 07/30/2001 3 days post vaccination, the pt experienced redness at the site and soreness. the pt sought unspecified medical attention. Additional information has been requested. Y U 07/10/2000 07/13/2000 3 OTH OTH hormonal contraceptives UNK WAES00071076 1
0174001 08/07/2001 83.0 F 07/30/2001 Information has been received from a consumer concerning her 83 yr old mother, who on 1 day post vaccination, experienced a very large, swollen, bright red area extending from the site of injection down her arm past the elbow. It was noted that fluid is also building up in the under arm area. The pt was taken to the physician's office and told it would eventually get better. It was reported that it had spread with the amount of fluid increasing. Additional information has been requested. Y N 07/12/2000 07/13/2000 1 OTH OTH UNK UNK WAES00071157 1
0174002 08/07/2001 WI 76.0 76 F 07/30/2001 One day post vaccination the pt developed an area of induration and erythema which measured approximately 8 X6 cm. There was some slight overlying warmness and no associated adenopathy. The pt sought medical attention. The reporting physician noted that he thought this represents a lical reaction. I do not thing there is anything here at this point to suggest cellulitis. i recommend some cool packs for 15-20 minutes at a time, for 2 or 3 times a day. On an unspecified date, the pt recovered. No further information is available. Y Y 06/05/2000 06/06/2000 1 PVT PVT UNK UNK WAES00071280 1
0174003 08/07/2001 ME U 07/30/2001 Post vaccination the pt developed cellulitis at the injection site. Additional information has been requested. Y U OTH OTH UNK UNK WAES00071379 1
0174004 08/07/2001 GA M 07/30/2001 It was reported from a male consumer that just hours post vaccination the pt became sick, developed a headache, fever, and extreme muscle pain at the injection site. Follow up information indicated that the patinet had an allergic reactio nto a dose of pneumococcal vaccine 23 polyvalent that made his arm red and swollen. The patient was later placed on therapy with rofecoxib and experienced a stiff neck, nausea, and chills. No further information is expected. Additional information has been requested. U OTH OTH UNK UNK WAES00071767 1
0174005 08/07/2001 UT 37.0 37 F 07/30/2001 The night of vaccination, the pt experienced hives. The next day the reaction worsened and the pt developed a local deltoid reaction and arthralgias. The pt sought medical attention and was rx with Claritin and a 9 day taper of Prednisone was started. The pt did not require hospitalization. The pt's symptoms persisted. Additional information has been requested. This is a consolidation of two reports concerning the same pt. Y N 07/18/2000 07/18/2000 0 OTH OTH UNK UNK WAES00071771 1
0174006 08/07/2001 CA U 07/30/2001 Reported from a woman in a clinic that pt experienced pain at injection site and developed cellulitis. The pt sought unspecified medical attention. Additional information has been requested. Y U OTH OTH UNK UNK WAES00072046 1
0174007 08/07/2001 FL F 07/30/2001 Pt developed a local reaction after vaccination. Additional information has been requested. pt was being treated with hydrochlorothiazide and other drugs and developed discoloration on her teeth. U OTH OTH aspirin,Calcium supplement, Premarin, Allegra, Hyzaar, Nasonex, Nyastatin, vitamins Codeine allergy, hypertension, ibuprofen allergy, sulfa allergy WAES00072429 1
0174008 08/07/2001 TX 55.0 M 07/30/2001 Pt had been vaccinated yrs ago with the pneumococcal vaccine 23 polyvalent. On 08/03/00, the pt presented to a physician complaining af arthritis and pain. It was noted that the pt insists that these symptoms occurred only after being vaccinated. The physician indicated that the pt was seen by several other specialists such as rheumatologists, radiologists, and other specialists who all concur that the test performed do not indicate rheumatoid arthritis. Additional information has been requested. Y U 08/02/2000 OTH OTH UNK UNK WAES00081399 1
0174009 08/07/2001 AZ 60.0 U 07/30/2001 Approximately 24 hours post vaccination, the pt experienced cellulitis at the injection site. Unspecified medical attention was sought. Additional information has been requested. Y U OTH OTH UNK bronchitis, pneumonia WAES00081587 1
0174010 08/07/2001 AZ U 07/30/2001 Post vaccination the pt developed injection site cellulitis. The pt sought unspecified medical attention. Y U OTH OTH UNK bronchitis WAES00081588 1
0174011 08/07/2001 FL F 07/30/2001 One day post vaccination the pt was swollen, indurated, and her arm was painful to move. It was indicated that ice and Tylenol seemed to help somewhat. The pt sought unspecified medical attention. Follow up information indicated that the pt had swelling, pain of the arm, cramps and myalgia. It was reported that the myalgia subsided somewhat on the first day. The pt recovered by 08/28/00 and no further information is expected. Y Y 08/15/2000 08/16/2000 1 PVT PVT UNK UNK WAES00081641 1
0174012 08/07/2001 CA F 07/30/2001 Information has been received from a registered pharmacist concerning a pt who was vaccinated in January 2000 and post vaccination she experienced an allergic reaction. Unspecified medical attention was sought. Additional information has been requested. Y U 01/01/2000 OTH OTH UNK UNK WAES00082011 1
0174013 08/07/2001 MA 75.0 75 F 07/30/2001 The pt was vaccinated with an expired vaccine, dated 07/08/2000. The day of vaccination was 08/22/2000. On the same day post vaccination, the pt experienced pain at the injection site and had marked erythema starting approximately 2 cm below the injection site extending to below the elbow by the next day. On 08/24/00 there was induration but no tenderness. The pt was seen by a physician and treated with soaks, Duricef and Benadryl. On 08/28/00 the pt recovered. No further information is available. Y Y 08/22/2000 08/22/2000 0 PVT OTH aspirin, Atenolol, Zestril coronary artery disease WAES00082587 1
0174014 08/07/2001 CA 74.0 74 F 07/30/2001 On 08/21/00 a pt was vaccinated at 14:15 and post vaccination at 19:00 the pt experienced mild to moderate soreness/pain at the injection site. The swelling affected the pt's ability to move her right shoulder. On 08/22/00 the pt had fever and chills; (99.2 F) which resolved on 08/23/00. She still had soreness and swelling and it began to move down to towards the elbow. The right elbow became swollen. On 08/24/00 the swelling moved from the right elbow to the forearm, approximately 2 inches below the elbow. Unspecified medical attention was sought. The pt took Tylenol on 08/21/22/00 to alleviate discomfort at the injection site. The pt was asymptomatic and recovered by 08/28/00. Y Y 08/21/2000 08/21/2000 0 PVT OTH Citrical, Premarin, Flovent, Levoxyl, Omega-1, Serevent chronic obstructive pulmonary disease, drug allergy WAES00082592 1
0174015 08/07/2001 CO 57.0 57 F 07/30/2001 Post vaccination at 5:00 PM the pt experienced redness (2/3 circumference of the arm). She also had swelling and tenderness from the shoulder to the elbow , some hand swelling, and pain through out the arm. It was also noted that the pt's underarm is very red. the pt was given antibiotics on 08/16/00 and the pt's arm has improved with the use of Keflex. The pt's swelling had extended below elbow and remained red until she started the antibiotic. Y Y 09/12/2000 09/12/2000 0 PVT PVT UNK antibiotic allergy, chronic obstructive pulmonary disease, penicillin allergy, sulfa allergy, steroid allergy WAES00091044 1
0174016 08/07/2001 NC 73.0 M 07/30/2001 Post vaccination the pt had a reaction from the injection site and down. the pt's arm was sore, red, and warm to the touch. Follow up information indicated that the patient also experienced edema. the symptoms occurred not just at the injection site but from the upper arm to the elbow. The pt was treated with a cold compress to the area and he was given Benadryl and Advil. Upon receipt of returned correspondence the pt is no longer symptomatic. Y N 09/13/2000 PVT OTH UNK UNK WAES00091194 1
0174047 08/07/2001 NC 69.0 69 F 07/30/2001 One day post vaccination the pt's arm was sore, red, and arm to touch from the upper arm to the elbow. Edema was also noted. Unspecified medical attention was sought, however it was noted that the pt was not seen in the ER or by a physician. follow up information from an physicians assistant reported that the pt's experiences have resolved. No further information is available. Y 09/12/2000 09/13/2000 1 NONE PVT OTH UNK Ceclor allergy; penicillin allergy; sulfa allergy WAES00091200 1
0174048 08/07/2001 NY F 07/30/2001 Information has been received from an RN with no past medical history or known allergies who on 8/19/00 was vaccinated with pneumococcal vaccine 23 polyvalent. There was no concomitant medication. Subsequently, the nurse developed a pain, swelling and redness at the injection site. The pt sough unspecified medical attention. Additional information has been reported. Y U 09/19/2000 09/19/2000 0 OTH OTH NONE NONE WAES00091987 1
0174049 08/07/2001 OH 65.0 F 07/30/2001 Information has been received from a physician concerning a 65 year old female pt who in approx. 1992 was vaccinated with a 1st dose of pneumococcal vaccine 23 polyvalent. The pt subsequently, received a booster dose of pneumococcal vaccine 23 polyvalent. Subsequently, the pt developed a "local type of reaction". It was noted that the area was red and warm. Unspecified medical attention was sought. Additional information has been requested. Y U OTH OTH UNK UNK WAES00092005 1
0174050 08/07/2001 NY 80.0 80 M 07/30/2001 Information has been received from an RN concerning an 80 year old male pt who on approx. 9/21/00 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot 629633/1693H). By approx. 9/27/00, the pt's injection site arm was swollen from his shoulder to fingers, tender and red and he had a fever of 101F. The pt sought unspecified medical attention. It was reported that another pt (WAES 00100373) had a similar experience following exposure with pneumococcal vaccine 23 polyvalent (lot 629633/1693H). Additional information has been requested. Y U 09/21/2000 09/27/2000 6 OTH OTH UNK UNK WAES00092357 1
0174051 08/07/2001 NC 65.0 65 F 07/30/2001 Information has been received from a health professional concerning a 65 year old Caucasian female pt who on 8/31/00 was vaccinated, IM, in the right arm with a 2nd dose of pneumococcal vaccine 23 polyvalent (lot 633103/1216J). There were no illnesses at the time of vaccination. On approx. 9/1/00, the pt experienced pain of the arm and it was noted that the arm was warm to the touch. She was "unable to move/life arm". The pt applied heat to the area and relief was noted. Tylenol was used for pain. On 9/22/00, the pt was seen in the physician's office for re-check. It was reported that the pain was better, but not resolved. Additional pts (WAES 0091200 & 00091194) had a similar experience following exposure to this same vaccine. Follow-up information from a physician's assistant indicated that the pt is no longer symptomatic, as of 11/2/00. No further information is available. Y Y 08/31/2000 09/01/2000 1 NONE PVT OTH UNK Allergy to ciprofloxacin and penicillin WAES00100010 1
0174052 08/07/2001 NJ 61.0 61 F 07/30/2001 Information has been received from a health professional concerning a 61 year old female physician who on 9/30/00 was vaccinated with pneumococcal vaccine 23 polyvalent (lot 633102/1217J). Subsequently, the pt experienced injection site redness, inflammation, swelling and a rash. The rash has also spread since 9/30/00. Unspecified medical attention was sought. No further information is available. Y U 09/30/2000 10/01/2000 1 UNK OTH OTH UNK UNK WAES00100155 1
0174053 08/07/2001 NJ 61.0 F 07/30/2001 Information has been received from a health professional concerning a 61 year old female who was vaccinated with pneumococcal vaccine 23 polyvalent (lot 633102/1217J). Subsequently, the pt experienced injection site redness and blistering. Medical attention was sought. No further information is available. Y U UNK OTH OTH UNK UNK WAES00100156 1
0174054 08/07/2001 NY 46.0 46 M 07/30/2001 Information has been received from an RN concerning a 46 year old male pt who on approx. 9/22/00 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot 629633/1693H). By approx. 9/27/00, the pt's injection site arm was swollen from his shoulder to finger, tender and red and he had a fever of 100F. The pt sought unspecified medical attention. It was reported that another pt (WAES 00092357) had a similar experience following exposure to the same vaccine and lot #. Additional information has been requested. Y U 09/22/2000 09/27/2000 5 UNK UNK UNK UNK UNK WAES00100373 1
0174055 08/07/2001 NY U 07/30/2001 Information has been received from a health professional concerning 3 pts who in approx. 9/00 were vaccinated with 1 dose of pneumococcal vaccine 23 polyvalent (lot 635893/0690K). Subsequently, the pts experienced cellulitis and malaise. The reporter expressed a concern with the lot number. Unspecified medical attention was sought. Additional information has been requested. Y U 09/01/2000 09/01/2000 0 OTH OTH UNK UNK WAES00100455 1
0174056 08/07/2001 AZ U 07/30/2001 Information has been received from a health professional concerning a pt who was vaccinated with pneumococcal vaccine 23 polyvalent. Subsequently, the pt experienced malaise, fever, nausea and vomiting, post vax. Unspecified medical attention was sough. No further information is available. Y U UNK OTH OTH UNK UNK WAES00100603 1
0174057 08/07/2001 NY 45.0 45 M 07/30/2001 Information has been received from a physician concerning a male pt who on 10/2/00 was vaccinated with pneumococcal vaccine 23 polyvalent. Subsequently, the pt experienced injection site swelling in the arm and a "low grade" temperature for approx. 4-5 days. Steroids were administered. Unspecified medical attention was sought. No further information is available. Y U 10/02/2000 10/02/2000 0 OTH OTH UNK Cardiac disorder; cephalosporin (Duricep) and penicillin allergies. WAES00100739 1
0174058 08/07/2001 LA 48.0 F 07/30/2001 Information has been received from a physician concerning a 48 year old female who in 2/00 was vaccinated with pneumococcal vaccine 23 polyvalent. In 2/00, the pt developed urticaria at the site of the injection (injection site wheal). It was noted at the time of the report in 10/00, that "for the past 8 months", the pt had experienced episodes of urticaria on her trunk and extremities which "comes and goes". The pt developed chronic sinusitis, was seen by ENT (otolaryngology) and was treated with Allegra and Flonase. The pt sought unspecified medical attention. Addition information has been requested. Y N 02/01/2000 02/01/2000 0 UNK UNK Cenestin; Pravachol Hypercholesterolemia; splenectomy; codeine and pentazocine allergies WAES00100742 1
0174059 08/07/2001 FL 81.0 81 F 07/30/2001 Information has been received from an RN concerning an 81 year old white female who on 10/2/00 was vaccinated with a 1st dose of pneumococcal vaccine 23 polyvalent, IM, the the right deltoid (lot 637094/0945K). On 10/4/00, the pt developed "red, warmth, edema 2.5" below injection site." On 10/5/00, the pt recovered. It was reported that the physician is concerned about using the remaining vaccine in the bottle. Two additional pts (WAES 0011721 and 0011722) had a similar experience following exposure to pneumococcal vaccine 23 polyvalent. Additional information has been requested. Y Y 10/02/2000 11/04/2000 33 PVT PVT UNK UNK WAES00100749 1
0174060 08/07/2001 LA 73.0 F 07/30/2001 On 10/9/00, two to three hours post vax the pt experienced a localized reaction of an "itchy, red rash, hot to the touch, but without pain" in her left arm. The pt sought unspecified medical attention. Additional information has been requested. Y U 10/09/2000 10/09/2000 0 UNK UNK UNK UNK WAES00100847 1
0174061 08/07/2001 TN U 07/30/2001 The pt experienced a cellulitis reaction to the vaccine site. The pt sought unspecified medical attention. No further details were provided. Y U UNK UNK UNK UNK WAES00100872 1
0174062 08/07/2001 MO 60.0 60 F 07/30/2001 Information has been received from a RN concerning pt with post hospital follow up on iron deficiency, anemia, and recent pneumonia at the time of vaccination. Pt was vaccinated on 10/03/00 and 1 day post vaccination she experienced injection site swelling, redness, and pain radiating to her elbow. Unspecified medical attention was sought. Follow up information indicated that the pt had huge swelling of the area at the site of injection. The pt also complained of pain. The swelling/edema was noted on the posterior aspect of the elbow. Y 10/03/2000 10/04/2000 1 UNK UNK UNK iron deficiency anemia, pneumonia erythromycin allergy; penicillin allergy WAES00101108 1
0174063 08/07/2001 CT M 07/30/2001 Pt received vaccine on 10/18/2000 and later on the pt experienced discomfort in the arm of injection. The site of the injection was warm and swollen. The pt developed a temperature of 102 F, headache, and nausea. On 10/19/2000 the pt came to the Dr's office, still felt feverish, arm still swollen with some improvement, some induration, and erythema. Y U 10/18/2000 10/18/2000 0 UNK UNK Percocet, Valium, Diflucan, MS Contin, acetaminophen pcn allergy WAES00101723 1
0174064 08/07/2001 NY 65.0 F 07/30/2001 Information has been received from a RN concerning a pt who was vaccinated in 1999. Subsequently, unspecified medical attention was sought and it was found that the pt had not seroconverted. Y U diagnostic laboratory -negative titer OTH OTH UNK UNK WAES00102065 1
0174066 08/07/2001 FL 32.0 32 F 07/30/2001 The pt was inadvertently vaccinated and subsequently, the pt had a bad asthma attack. In follow up the pt went to the ER. Y U 10/26/2000 OTH OTH UNK Asthma; sulfa allergy WAES00102308 1
0174067 08/07/2001 FL M 07/30/2001 Post vaccination the pt developed a local injection site reaction which resulted in cellulitis. The pt sought unspecified medical attention. Y U OTH OTH UNK UNK WAES00102350 1
0174068 08/07/2001 NJ F 07/30/2001 Information has been received from a physician concerning his wife who was receiving other concomitant medications which are unknown. The pt developed cellulitis of the right arm from the elbow to the shoulder, a stiff neck, nausea, anorexia and orthostasis. the pt sought unspecified medical attention. Additional information has been requested. Y U 10/23/2000 10/23/2000 0 OTH OTH UNK Breast malignant neoplasm, systemic lupus erythematosus WAES00102422 1
0174069 08/07/2001 OK M 07/30/2001 The pt was inadvertently vaccinated and subsequently turned red in color all over his body. He experienced tingling in his legs and feet and became clammy. The pt was observed in the physician's office. Y U UNK UNK UNK UNK WAES00102542 1
0174070 08/07/2001 MD 80.0 M 07/30/2001 Post vaccination the pt developed swelling and redness from the elbow to shoulder. The pt sought unspecified medical attention. Y U 10/20/2000 10/21/2000 1 OTH OTH UNK UNK WAES00102562 1
0174071 08/07/2001 MD 66.0 F 07/30/2001 One day post vaccination the pt developed swelling and redness from the elbow to the shoulder. The pt sought unspecified medical attention. Y U 10/25/2000 10/26/2000 1 OTH OTH UNK Hx of breast malignant neoplasm WAES00102575 1
0174072 08/07/2001 MD F 07/30/2001 Post vaccination the pt experienced swelling, redness, and blotchy knot at injection site. She applied ice to the site and took Benadryl and the sx began to subside. Y 10/27/2000 10/27/2000 0 UNK UNK UNK UNK WAES00110150 1
0174073 08/07/2001 NC 43.0 43 F 07/30/2001 On the evening of 10/30/00 post vaccination the pt experienced 8 to 9 cm deltoid erythema with some induration, swelling and pain at the injection site. the physician reported the erythema was 2 cm away from injection site. The area appeared scalded. On 11/01/00 the pt was seen by her Dr and Claritin, ice and Benadryl were prescribed without any relief. The pt did recover. Y Y 10/30/2000 10/30/2000 0 UNK UNK Histussin -HC syrup, doxycycline, Medrol bronchitis NSAID allergy; amoxicillin allergy; aspirin allergy WAES00110345 1
0174074 08/07/2001 IL M 07/30/2001 Information has been received concerning a pt who on 10/31/00 was vaccinated and post vaccination on 11/02/00 the pt complained of redness, swelling, and induration. U 10/31/2000 11/02/2000 2 UNK UNK UNK WAES00110356 1
0174075 08/07/2001 TX U 07/30/2001 Information has been received concerning pt that was vaccinated and subsequently experienced a sore arm and swollen lymph glands. U UNK UNK UNK WAES00110385 1
0174076 08/07/2001 MI F 07/30/2001 Information has been received concerning a pt with myasthenia gravis, arthritis and has used a wheelchair with a history of influenza symptoms and pneumonia on 01/012000 that resulted in hospitalization. On 11/02/00 the pt experienced soreness and her nose was runny. On11/03/00 the pt reported her eyes feel funny like she was getting a cold, and has a sore throat and a tight feeling in her chest. Y U 11/01/2000 11/02/2000 1 UNK UNK aspirin w/codeine phosphate, Premarin, globulin immune, Synthroid, Provera, Vivactil medical history influenza sx, pneumonia, concurrent conditions: arthritis, wheelchair user, myasthenia gravis WAES00110462 1
0174077 08/07/2001 IL F 07/30/2001 Information has been received from a Pharm. D concerning a female pt who on 10/31/00 was vaccinated. On approximately 11/02/00 the pt complained of redness, swelling and induration. U 10/31/2000 11/02/2000 2 UNK UNK WAES00110505 1
0174078 08/07/2001 49.0 49 M 07/30/2001 Information has been received from a woman concerning her husband who on 11/05/00 was vaccinated and on 11/05/00 post vaccination he developed a temperature of 102 and bronchitis. She stated that on 11/06/00 her husband's temperature went to 104 and he was experiencing chills. Additional information has been requested. N 11/05/2000 11/06/2000 1 Temperature taken on 11/05/00 was 102 and on 11/06/00 it was 104 UNK UNK Zithromac, Synthroid, testosterone Bronchitis, fever eggs allergy WAES00110524 1
0174079 08/07/2001 M 07/30/2001 Information has been received from a wife concerning her husband who was vaccinated while having a cold and fever of 102 F. She stated, At this time the fever is over 102 F. U Temperature measurement was over on 11/06/00 UNK UNK UNK common cold; fever WAES00110557 1
0174080 08/07/2001 IL 74.0 74 F 07/30/2001 Information has been received concerning a pt who was vaccinated on 10/17/00 and on 10/18/00 she developed cellulitis at the injection site, with redness, edema, and warmth. The pt was seen by a physician and treated with Zithromax and she recovered. Y Y 10/17/2000 10/18/2000 1 OTH OTH UNK UNK WAES00110641 1
0174081 08/07/2001 IL 74.0 74 F 07/30/2001 Information has been received from a registered nurse concerning a pt who on 10/17/00 was vaccinated and one day post vaccination, the pt developed injection site cellulitis described as redness and swelling at the injection site. The pt was seen by a physician and treated with Zithromax. Y U 10/17/2000 10/18/2000 1 OTH OTH UNK UNK WAES00110644 1
0174082 08/07/2001 80.0 F 07/30/2001 Information has been received concerning a pt who was vaccinated and subsequently developed cellulitis. The pt was treated with antibiotics. U UNK UNK UNK UNK WAES00110647 1
0174083 08/07/2001 PA 28.0 26 F 07/30/2001 Information has been received concerning a pt who has been vaccinated from 1994 to 1999 with the pneumoccal vaccine 23 polyvalent on an annual basis. the physician reported that the pt no significant effects, only transient low grade fever, myalgias, and tenderness at injection site. the physician reported that the patient will not receive any further dose of pneumococcal vaccine 23 polyvalent until age 65. U 01/01/1999 PVT PVT UNK allergy, cardiac murmur, gastroesophageal reflux disease; ibuprofen allergy, muscular dystrophy, penicillin allergy, and sulfa allergy WAES00110721 1
0174084 08/07/2001 TX 32.0 32 F 07/30/2001 Information has been received concerning pt who was vaccinated on 11/01/00 and at 19:00, the pt experienced pain, tenderness, and soreness along her right arm and underarm, especially around the lymph area. She reported swollen lymph glands and her arm was to sore and uncomfortable to move. On approximately 11/04/00 the pt recovered from her experiences. Y 11/01/2000 11/01/2000 0 UNK UNK UNK chronic bronchitis, erythema at injection site to influenza vaccine, Epstein Barr virus, chronic fatigue syndrome, sulfa allergy WAES00110778 1
0174085 08/07/2001 TX 46.0 46 F 07/30/2001 After being vaccinated that evening, the pt experienced swollen lymph glands and soreness under her left arm and arm pit. On 11/01/2000 the pt recovered. Y 10/27/2000 10/28/2000 1 UNK UNK UNK UNK WAES00110779 1
0174086 08/07/2001 IL U 07/30/2001 Information has been provided that a pt had been given a pneumococcal vaccine and influenza vaccine in the same syringe. The pt experienced some cellulitis at the injection site but no other symptoms were noticed. U UNK UNK UNK WAES00110931 1
0174087 08/07/2001 MI 65.0 F 07/30/2001 One day post vaccination, the pt was seen by the Dr for redness, severe pain, warmth and swelling of the left deltoid. There was an appearance of a band around the area. She was placed on Keflex and responded well. Y N 11/06/2000 11/10/2000 4 Ultrasound for deep vein thrombosis was negative UNK UNK UNK UNK WAES00111324 1
0174088 08/07/2001 NY U 07/30/2001 Information has been received from a woman concerning 4 pts who were vaccinated with the same vaccine and subsequently, the pts experienced cellulitis. U UNK UNK UNK UNK WAES00111334 1
0174089 08/07/2001 PA 70.0 70 F 07/30/2001 This concerns a pt who was vaccinated with pneumococcal vaccine 23 polyvalent and influenza vaccine on 11/14/2000 on the opposite arm. On 11/15/2000 the arm was very swollen with red half dollar size raised area directly at site of injection. The pt had difficulty raising her arm due to muscle soreness. The nurse informed the pt to apply cold and take Benadryl or Actifed and to call if there was any additional problems. U 11/14/2000 11/15/2000 1 UNK UNK Lanoxin, estrogens, Zocor cardiomyopathy, codeine allergy, hypercholseterolemia WAES00111438 1
0174090 08/07/2001 CA 75.0 75 F 07/30/2001 Information has been received on a pt who was vaccinated on 11/13/00, post vaccination the pt experienced redness, warmth, baseball size area and difficulty raising arm. U 11/13/2000 11/13/2000 0 UNK UNK UNK UNK WAES00111467 1
0174091 08/07/2001 CA 64.0 64 F 07/30/2001 Post vaccination the pt experienced redness, warmth, baseball size area and generalized flu-like pain. U 11/06/2000 11/06/2000 0 UNK UNK UNK UNK WAES00111468 1
0174092 08/07/2001 IL 65.0 F 07/30/2001 The pt developed cellulitis post vaccination. The pt was seen by a physician and treated with antibiotics Y U UNK UNK UNK UNK WAES00111515 1
0174118 08/07/2001 IL 80.0 F 07/30/2001 Information has been received about a pt who developed cellulitis post vaccination. the pt was seen by a physcian and treated with antibiotics. Y U 10/18/2000 UNK UNK UNK UNK WAES00111516 1
0174119 08/07/2001 MA 56.0 56 F 07/30/2001 Pt was vaccinated on 11/17/1997 and on 11/20/1997 she experienced rash around upper arm and a hard part on the under section of the arm. therapy with antibiotics wee started and the pt recovered. Subsequently, the pt's arm muscle had become weak and she has experienced arm pain. the pt has been attending physical therapy for this condition. Y 11/17/1997 11/20/1997 3 UNK UNK Amitriptyline, Lamictal, Synthroid, Ritalin Medical history includes Lyme disease; encephalitis; concurrent conditions chronic fatigue, lactose intolerance WAES00111551 1
0174120 08/07/2001 FL 74.0 74 F 07/30/2001 Pt was vaccinated and one day post vaccination, the pt developed redness, warmth, edema, and mild itching from left shoulder to elbow. Within 3 days of onset the pt recovered. Y Y 09/27/2000 09/28/2000 1 UNK UNK UNK allergy to aspirin. codeine, iodine WAES00111721 1
0174121 08/07/2001 FL 75.0 75 M 07/30/2001 Information has been received about a pt who on same day of vaccination developed edema right arm , wrist to shoulder for 4 days. On 10/08/00 the pt recovered. Y Y 10/04/2000 10/04/2000 0 PVT PVT UNK Parkinson's disease, aspirin allergy and sulfa allergy WAES00111722 1
0174123 08/07/2001 NY F 07/30/2001 Information has been received concerning a female who was recently vaccinated and subsequently, the pt complained of swelling, sore, and erythema at injection site. In follow up, the pt's experience was described as unknown. The pt recovered 7 days post vaccination. the pharmacist would like lot # checked for recall or irregularities. The records of testing prior to release of this lot have been checked by Biological Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biological Evaluation and Research and was released. Y 10/01/2000 PVT UNK UNK UNK WAES00111766 1
0174124 08/07/2001 NY F 07/30/2001 Information has been received concerning a nurse who post vaccination experienced a sore arm and fever of 104 F. The pt was treated at a medical center. Additional information has been requested. Y U temperature measurement 104 F UNK UNK UNK UNK WAES00111774 1
0174125 08/07/2001 NJ 56.0 56 F 07/30/2001 Fever; body ache; cognitive disturbance; injection site pain; injection site swelling; injection site erythema; disorientation. Information has been rec'd from a phys and a RN concerning a 56 yo pt who on 11/17/00 was vaccinated at 14:00 with pneumococcal vaccine 23 polyvalent (635898/0820K),IM. The RN reported that on 11/18/00 the pt experienced pain, swelling and redness in injection site and left arm, body aches and fever greater than 102F. The phys reported on 11/18/00, the pt experienced a swollen, painful arm, fever to 103F times 3 days. The phys reported that the pt was disoriented and experienced a loss of cognition and saw specialist. The pt's white blood cell count was 11.2 (10-3/ul) on blood drawn 11/18/00. The pt was treated with Amoxicillin trihydrate (Amoxil) 500mg 3 times daily. The RN reported that the pt was feeling a little better. The phys reported hat the pt recovered from the swollen, painful arm, fever, disorientation and loss of cognition on 11/25/00. No further information is available. Y Y 11/17/2000 11/18/2000 1 WBC count 11/18/00 11.1x10-4.0-13.5 high PVT PVT UNK Concurrent conditions: cat allergy WAES00111800 1
0174126 08/07/2001 IN 35.0 35 F 06/05/2002 Injection site erythema; injection site induration; injection site warmth. Information has been rec'd from a RN concerning a pt with allergies to nitrofurantolin and with migraines who on 4/27/00 was vaccinated at 13:00 with pneumococcal vaccine 23 polyvalent (lot 630096/0044J) IM in the L deltoid. Concomitant vaccines included tetanus toxoid vaccine (lot 467-047) administered IM in the L deltoid. Subsequently the pt experienced injection site redness, warmth and a knot. A visit to a phys was required. Subsequently, the pt recovered. Other pt's had a similar reactions following vaccination with pneumococcal vaccine 23 polyvalent (WAES00061196 and 00111855). No further information is available. The pneumococcal vaccine 23 polyvalent infection site was changed from IM left deltoid to SC right deltoid. The time of vaccination was changed from 13:00 to 13:30 and venue of vaccination was added. The county in which the vaccinee was administered was added. The narrative was edited. Y Y 04/27/2000 04/27/2000 0 PVT OTH Concurrent conditions: migraine; nitrofurantoin allergy WAES00111855 1
0174127 08/07/2001 MA M 07/30/2001 Information has been received concerning a pt who post vaccination, had a site reaction with pain at the injection site and redness from his shoulder to his wrist. U 11/01/2000 UNK UNK UNK WAES00111882 1
0174128 08/07/2001 IL 90.0 F 07/30/2001 Information has been received concerning a 90 year old female, who post vaccination developed cellulitis in her right arm from her elbow to her shoulder and she had chills. U 11/14/2000 11/15/2000 1 UNK UNK UNK UNK WAES00111890 1
0174129 08/07/2001 IL 50.0 F 07/30/2001 Information has been received concerning a female who post vaccination, experienced a temperature of 101, chills, and injection site reaction that was 4 X 4 inches, swollen and warm to touch. U 11/20/2000 11/21/2000 1 temperature measurement on 11/21/00 was 101 F UNK UNK UNK UNK WAES00112007 1
0174130 08/07/2001 MN 59.0 59 F 07/30/2001 Information has been received concerning a pt who post vaccination experienced a severe local reaction, the entire upper arm was very swollen,red, hot, tight and severely painful. On 11/17/00 it was reported the pt had dizziness and unspecified medical attention was sought. The pt recovered from her experience on 11/20/2000. Y Y 11/16/2000 11/16/2000 0 OTH OTH Atenolol, Lipitor, Prevacid Medical history: cholecystic surgery, concurrent conditions: Amoxicillin allergy, hypercholesterolemia, and atherosclerosis WAES00112116 1
0174131 08/07/2001 MN 57.0 57 F 07/30/2001 Information has been received concerning a female who post vaccination experienced a severe local reaction that started within 24 hours and lasted 3 days. The entire arm was very swollen, red, hot, tight and severely painful. It was reported that the pt's experience resolved on 11/27/00. Y Y 11/20/2000 11/21/2000 1 OTH OTH amitriptyline, Premarin, Prozac, Zantac Chronic pancreatitis, depression, sulfa allergy WAES00112123 1
0174132 08/07/2001 TX 50.0 F 07/30/2001 Information has been received concerning a vaccinee who experienced a sore arm and swelling in the arm and didn't feel well all night. Unspecified medical attention was sought. Y U 10/01/1999 10/01/1999 0 UNK UNK UNK antibiotic and aspirin allergy WAES00112232 1
0174133 08/07/2001 TX 89.0 89 F 07/30/2001 On 11/22/00 at 8:00 PM, the pt experienced slight redness at the injection site. The pt also complained of pain, warmth and the site was hard to the touch. A physician was consulted and the pt was prescribed moist compresses and diphenhydramine hydrochloride every four hours as needed. Subsequently, the pt recovered. No additional information is expected. Y Y 11/22/2000 11/22/2000 0 UNK UNK UNK UNK WAES00112273 1
0174217 08/07/2001 FL F Post vaccination the pt developed a local injection site reaction described as redness and pain. The pt sought unspecified medical attention. No further information is available. Y U OTH OTH UNK UNK WAES00112351 1
0174218 08/07/2001 LA 50.0 F 07/30/2001 One day post vaccination the pt experienced a localized reaction in her left arm including pain that radiated to the shoulder area, redness, and swelling. The pt sought unspecified medical attention. Additional information ha been requested. Y U 09/14/2000 09/15/2000 1 UNK UNK UNK UNK WAES00112403 1
0174219 08/07/2001 MD 57.0 57 F 07/30/2001 Information has been received from a pt's husband and a RN that post vaccination the pt developed a fever on 2 occasions of up to 102 F. the pt was seen the the Dr's office a few days later with a skin reaction of left deltoid, are 6X8 cm indurated with erythema, aching,. At this time the pt was afebrile. The local reaction resolved by 11/20/2000. The pt's Dr reported that the pt developed a moderately severe local reaction. The pt complained of chills and general malaise. The husband reported that she had a nodule in the back of her throat which has gone away. The pt has been developing a fever off and on with weakness and fatigue. Y N 11/16/2000 11/17/2000 1 chest xray was negative; blood test negative; serum CMV IgG Ab value 1.48 on 12/04; on 12/27 it was 2.08; on 12/04 it was 3.7; on 12/27 it was 2.3. Temperature went between 100-102 degrees F PVT PVT UNK pneumonia, cytomeglaovirus infection; prednisone allergy and sulfa allergy WAES00120028 1
0174220 08/07/2001 NE 74.0 72 F Two days post vaccination the pt experienced severe redness, swelling, and muscle in the right arm. the pt did not seek medical attention and recovered around 10/25/1996 Y 10/21/1996 10/23/1996 2 PVT PVT UNK UNK WAES00120029 1
0174221 08/07/2001 NY 65.0 F 07/30/2001 On 11/17/00, the pt developed swelling and pain in the arm that had the injection. The pt's physician diagnosed the pt with a bacterial infection. the pt was put on antibiotics for a few weeks. the pt's condition resolved. Y 11/11/2000 11/12/2000 1 UNK UNK UNK UNK WAES00120118 1
0174222 08/07/2001 PA 47.0 M 07/30/2001 Information has been received from a wife concerning her 47 year old husband who was vaccinated on 11/28/00. 5 minutes after the vaccination, the pt experienced hot and cold sweat, nausea, and was dizzy. The physician's office also noted that the pt's blood pressure dropped. The wife states the the physician felt that the pt's experiences were related to the vaccination. Y U 11/28/2000 11/28/2000 0 UNK UNK allopurinol and prednisone Crohn's disease and penicillin allergy WAES00120119 1
0174223 08/07/2001 SD U 07/30/2001 Information has been received from a licensed practical nurse concerning 4 or 5 pt who in 2000 were vaccinated with pneumovax-23. The LPN stated that it seems 4 or 5 of our younger pts that got this vaccine this year had some mild site reaction. Additional information has been requested. U UNK UNK UNK WAES00120133 1
0174224 08/07/2001 IL 57.0 57 M 07/30/2001 Within the hour post vaccination the pt experienced a local reaction which included erythema, warmth, which spread distally to the elbow. 20 cmX20 cm with difficulty extending the arm and right thumb. Y U 11/29/2000 11/29/2000 0 UNK UNK UNK WAES00120139 1
0174225 08/07/2001 VA F 07/03/2001 Information has been received concerning a person who experienced a swollen arm with hive like red rashy skin. She also developed 3 lumps that were 2 inches in diameter each at injection site. The pt sought unspecified medical attention. Y U 10/20/2000 UNK UNK UNK UNK WAES00120273 1
0174226 08/07/2001 CA 70.0 70 F 07/30/2001 Information has been received concerning a 70 year old who, 2 days post vaccination developed a large amount of swelling at the injection site. The nurse reported that it was hot to the touch. the pt also developed redness which traveled down the pt's arm. The pt saw her physician who advised her to use an ice pack and observe for infection. The physician prescribed Atarax. Y Y 12/04/2000 12/06/2000 2 PVT OTH UNK WAES00120490 1
0174227 08/07/2001 PA 66.0 66 F 07/30/2001 Information has been received concerning a pt who post vaccination, experienced excruciating arm pain within 10 hours of vaccination. The pt told nurse the pain was so severe that she soaked in the tub and could not sleep all night. The pt also experienced nausea. Unspecified medical attention was sought. The intervention for this pt was hot compresses and anti-inflamatory. Y U 12/05/2000 12/05/2000 0 OTH OTH UNK UNK WAES00120586 1
0174228 08/07/2001 PA M 07/30/2001 Information has been received concerning a male who post vaccination had an adverse reaction. Unspecified medical attention was sought. There is not any more information, additional information has been requested. Y U UNK UNK UNK UNK WAES00120590 1
0174229 08/07/2001 MD 23.0 M 07/30/2001 Information has been received concerning a pt, who after 2 days post vaccination returned to his physician with redness, swelling, and soreness in left arm and fever of 100.3 F. Y U 12/06/2000 12/08/2000 2 UNK UNK UNK WAES00120716 1
0174232 08/07/2001 DC 33.0 33 M 07/30/2001 Information has been received concerning a pt who on the same day of vaccination developed localized significant redness, swelling, and warmth of the third outer aspect of his upper arm. The pt also developed a fever of 103 and experienced malaise. The pt received unspecified over the counter medications for the fever. The pt recovered in 4 to 5 days. Y 10/03/2000 10/30/2000 27 UNK UNK UNK UNK WAES00121033 1
0174233 08/07/2001 U 07/30/2001 Information has been received regarding a case involved in litigation concerning a pt who may or may not have experienced an unspecified adverse event. U UNK UNK UNK UNK WAES00121100 1
0174234 08/07/2001 MI 33.0 36 F 07/30/2001 Information has been received concerning a pt who on 1 day post vaccination complained of a swollen arm at the site of injection, welt in the same area which grew to the size of a golf ball. She complains of aches over entire body and fever of 100 F. The pt stated that she reported this to her physician. Y U 12/11/2000 12/12/2000 1 UNK UNK UNK allergy to animal dander, cat and dog, and asthma WAES00121254 1
0174235 08/07/2001 CA 31.0 F 07/30/2001 Information has been received concerning a person who was vaccinated and 6 to 8 hours later she experienced soreness, redness and induration of the right arm, body aches, nausea and vomiting and a fever of 102 F. She sought unspecified medical attention. The pt's fever went down after taken Motrin. Y U 12/15/2000 12/15/2000 0 UNK UNK UNK allergy WAES00121507 1
0174236 08/07/2001 IL M 07/30/2001 Information has been received concerning a male pharmacist who post vaccination experienced some mild flu like symptoms. In follow up the pharmacist reported that the flu was going around, so the injection probably didn't cause the problem U UNK UNK UNK asthma WAES00121604 1
0174237 08/07/2001 NH 62.0 62 F 07/30/2001 Information had been received concerning a pt who was post vaccination 1 day and she experienced 5 inch area on upper arm that the skin was red, hot, and swollen. The pt recovered. Y Y 02/13/2000 02/14/2000 1 PVT PVT beonchiectasis Septra allergy, drug allergy WAES00121825 1
0174238 08/07/2001 GA M 07/30/2001 Information has been received regarding 2 males who both experienced injection site soreness, swelling and injection site rash. Unspecified medical attention was sought. Y U 11/01/2000 UNK UNK UNK Medical history : splenectomy WAES00121851 1
0174239 08/07/2001 WY 36.0 36 F 07/30/2001 Information has been received concerning a pt who 1 day post vaccination experienced deep muscle pain with some redness across the arm. It was reported that the pt gets some relief by alternating ibuprofen and Tylenol about every 3 hours. The outcome of the redness is unknown. Follow up information said the pt was seen at Dr's office and was grimacing in pain. No significant swelling was noted. No laboratory work was done. Her Dr feels that her arm is sore due to her building up a good immuno response to vaccination. The pt called and said she was doing great. Y Y 12/23/2000 12/24/2000 1 PUB OTH UNK history of pneumonia WAES00122215 1
0174240 08/07/2001 CT M 07/30/2001 Information has been received concerning a male physician who experienced post vaccination a localized reaction that was 6 to 7 inches wide with swelling and tenderness that continued to spread until it was 210 degrees around circumference of the thigh. The site was warm to touch and he was unable to walk for 48 hours. Y 12/29/2000 12/29/2000 0 UNK UNK Atenolol, Procardia, Zoloft depression, hypertension WAES01010244 1
0174241 08/07/2001 IA 66.0 66 F 07/30/2001 Information has been recvd from a registered nurse. On 11/2/00, pt developed redness, warmth and hives on the upper arm. The pt observed this, and on an unspecified date, the symptoms subsided. The pt was seen on 1/4/01 for a non-associated visit. Conflicting follow-up info recvd from the registered nurse reported that the pt was vaccinated on 11/2/00, and the pt stated that she "had a local irritation and generalized rash approximately one week later." The pt did not inform the MD's office of the adverse experienced until 1/4/01. It was reported that the pt recovered in 12/2000. No further info is expected. Y 11/02/2000 11/02/2000 0 OTH OTH NONE NONE Drug allergy, idiopathic myelofibrosis WAES01010340 1
0174242 08/07/2001 CT M 07/30/2001 Post vax, the pt experienced an injection site reaction and flu-like symptoms. Unspecified medical attention was sought. The reported also reported an additional pt (WAES 01020057). Addtl info has been requested. Y U UNK UNK UNK UNK WAES01010737 1
0174243 08/07/2001 UT 53.0 M 07/17/2001 Information has been received from a 53 year old male consumer with allergies to NSAID's who on 12/21/00 was vaccinated with ine dose of pneumococcal vaccine 23 polyvalent. It was noted that the paatient was not sure if the vaccine was pneumococcal vaccine 23 polyvalnet, he just stated "pneumonia shot". Concomitant medications include levothyroxine sodium (Synthroid), folic acid, "Lomoto", sildenafil citrate (Viagra), ascorbic acid (vitamin C0, vitamin E, calcium, cetirizine hydrochloride (Zyrtec), diphenhydramin (Benadryl), "Desoin", amcininide (Cylocort). A couple of days later the patient developed a rash under the armpits and then it started to spread to his arms and legs. The patient sought medical attention from a dermatologist. The patient had received a pneumonia shot thirteen years ago and had no side effects. On an unspecified date, the patient also experienced fever. It was reported that no serious criteria were met. This was originally reported by a physician. Additional information has been requested. FOLLOW-UP information received 10/10/02 states, " A male reported that he received an injection of Pnu-Imune-23. The following day, he developed a fever which lasted for one day. Subsequently, he developed a rash under his arm and down his side. The patient was seen by a dermatologist and treated with an unspecified antihistamine. The reporeter indicated that the rash is improving; however, it is starting to spread to his chest and stomach. CANCELLED: Follow Up information received on 07/02/01 indicated that the patient received Pneumomavax 23 vaccine on 12/21/00. This information has been to the manufacturer of Pneumovax 23." Y U UNK OTH OTH UNK UNK UNK HQ5880912JAN2001 1
0174244 08/07/2001 NH 46.0 46 F 07/30/2001 Info has been recvd from a registered nurse. On 12/14/00, pt recvd vax. On 12/15/00, pt experienced raised rash from shoulder to elbow. The pt did not have any pain, fever or swelling. Subsequently, as of 12/19/00, pt's symptoms were almost completely resolved. No follow-up, work-up or hospitalization was necessary. Unspecified medical attention was sought. No further info is expected. Y Y 12/14/2000 12/15/2000 1 UNK UNK UNK Chronic obstructive pulmonary disease Morphine allergy, tetracycline allergy WAES01011035 1
0174245 08/07/2001 MI U 07/30/2001 Information has been recvd from an MD concerning an unspecified number of patients who were vaccinated with 1 dose of pneumococcal vaccine 23 polyvalent (lot #1448K). The MD reported that over the past couple of months (prior to reporting the events on 1/15/01) it seems that a lot of pts developed "red, sore arms" post vax. The MD stated "We have been using your vaccine for many years for a (pneumococcal vaccine 23 polyvalent) but we're having an unusual amount of local reactions to the shots that we're giving patients to the point where they're really quite angry, red, sore, more so than in the past. Is this just peculiar to a Lot Number that we might have or is this something new that you put in the vaccine that you've been having trouble with?" It was also noted that the pts "can't use (their arm) for 2 or 3 days." The MD was unable to provide specific pt information at the time of the report. Medical attention was sought. Also noted, the MD stated that more than one lot was involved. The records of testing prior to release of lot #1448K have been checked by Biological Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biological Evaluation and Research and was released. Follow-up info for the MD stated that he has given this drug in the past years and "I don't think I've had more than 1 or 2 sore arms in whole year." It was also noted that the MD checked his records and noted having a total of 6 "reactions" this year already. Addtl info has been requested. Y U OTH OTH UNK UNK WAES01011241 1
0174246 08/07/2001 NY M 07/30/2001 Information has been recvd from 2 registered nurses concerning a male who in approximately 1/1998 was vaccinated with pneumococcal vaccine 23 polyvalent. Subsequently, pt experienced swelling at the injection site. The injection area was red, and he also experienced nausea and fatigue for a few days. The swelling went down without any medical treatment. Addtl info is not expected. N 01/01/1998 01/01/1998 0 UNK UNK UNK UNK WAES01011832 1
0174247 08/07/2001 PA 62.0 F 07/30/2001 Pt was vaccinated in 2000 with pneumococcal vaccine 23 polyvalent (site unk). Since approximately 1999, pt was also vaccinated with hepatitis A vaccine, hepatitis B vaccine and influenza virus vaccine. With each subsequent vaccination, pt developed greater hair loss, even on her arms. No further info is available. U OTH OTH Hair loss WAES01012493 1
0174248 08/07/2001 CT F 07/30/2001 Post vax, pt experienced an injection site reaction and flu-like symptoms. Unspecified medical attention was sought. The reporter also reported an additional pt (WAES 01010737). Addtl info has been requested. Y U UNK UNK UNK UNK WAES01020057 1
0174249 08/07/2001 NM 73.0 73 F 07/30/2001 On 10/5/00, pt's left arm was very swollen, red and tender. Therapy with acetaminophen (Tylenol) was initiated along with cold compresses. At the time of this report, the pt had not recovered. Addtl info has been requested. Y N 10/04/2000 10/05/2000 1 PVT PVT UNK Hypercholesterolemia, mitral valve prolapse, postmenopausal WAES01020487 1
0174250 08/07/2001 NM 74.0 75 F 07/30/2001 Information has been received from a health professional concerning a 74 year old female with hypothyroidism and post menopause who on 10/4/00 was vaccinated with pneumococcal vaccine 23 polyvalent in the left deltoid (633103/lot 1216J). On 10/5/00, the pt developed left upper arm redness, heat and minimal swelling. She was treated with methylprednisolone (Medrol Dosepak). Subsequently, the pt recovered. The reporter indicated that other pts experienced events following vaccination (WAES 01020487, 01020489, 01020490 and 00102088.) Additional information is not expected. Y Y 10/04/2000 10/05/2000 1 PVT PVT UNK Hypothyroidism; post menopause WAES01020488 1
0174251 08/07/2001 NM 75.0 75 M 07/30/2001 In approximately 10/2000, pt was vaccinated with pneumococcal vaccine 23 polyvalent. On 10/04/00, pt experienced swelling and redness on the day after vaccination. The pt was seen by MD who noted several bright red spots on the left arm, one over the bicep, not palpable but almost vasculitic in nature. There was some diffuse redness in the lower arm. Possible allergic reaction or vasculitis. No infection. Subsequently, the pt recovered. The reporter indicated that other pts experienced events post vax: WAES 01020487, 01020488, 01020490 and 00102088. Addtl info has been requested. Pt has a history of vaccination with pneumococcal vaccine 23 polyvalent in 1/1992. Y Y 10/03/2000 10/04/2000 1 PVT PVT UNK Benign prostatic hyperplasia; chronic obstructive pulmonary disease; hypertension WAES01020489 1
0174252 08/07/2001 NM 68.0 68 F 07/30/2001 One day post vax, 10/20/00, pt developed a red, hot, tender, swollen area on the inner aspect of her left lower arm measuring 17 cm by 24 cm. Therapy with cephalexin (Keflex) and diphenhydramine HCl (Benadryl) was initiated. The symptoms resolved on 10/27/00. The reporter indicated that other pts experienced events post vax: WAES 01020487, 01020488, 01020489 and 00102088. Addtl info has been requested. Y Y 10/19/2000 10/20/2000 1 PVT PVT UNK Hypothyroidism WAES01020490 1
0174253 08/07/2001 CO M 07/30/2001 Pt developed a "severe cellulitis" about 2 weeks after receiving vaccine. It was reported that the nurse alluded to the fact that this was "not an isolated case." Unspecified medical attention was sought. Addtl info has been requested. Y U OTH OTH UNK UNK WAES01021970 1
0174254 08/07/2001 TX F 07/30/2001 Information has been recvd from a pharmacist concerning a patient. Pt's first dose of pneumococcal vaccine 23 polyvalent was administered in 1995. Pt recvd concomitant therapy in the same arm but administered with a different syringe. On 2/19/00, pt experienced a fever and redness, pain and swelling of the injection sites from the shoulder to the elbow. On 2/23/01, pt was seen by MD and was placed on prednisone. Subsequently, the symptoms are subsiding. No further info was provided. Addtl info has been requested. Y N 02/19/2001 02/19/2001 0 OTH OTH UNK WAES01030007 1
0174255 08/07/2001 NH U 07/30/2001 Information has been received from a hospital worker concerning two pts who in 2/2001 were vaccinated with pneumococcal vaccine 23 polyvalent (lot #1237K). Subsequently, pts experienced cellulitis. Unspecified medical attention was sought. No other information was available. It was reported that another pt (WAES 01030309) had an adverse experience after receiving same vax with the same lot #. The reporter expressed a concern with the lot. The records of testing prior to release of this lot have been checked by Biological Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Addtl info has been requested. Y U 02/01/2001 02/01/2001 0 OTH OTH UNK UNK WAES01030154 1
0174256 08/07/2001 NY 73.0 73 F 07/30/2001 On 3/6/01, pt's left arm (which was the arm in which she recvd injection) swelled, and she experienced malaise. Later in the evening, pt became "ill" and was sweating, nauseous (vomited), had "irritable bowel syndrome" (not confirmed by MD). On the following day, pt's arm was still swollen, she was still "sick" and could not get out of bed or eat. The swelling then went up to the elbow and a rash occurred on her upper arm. On 3/12/01, pt recovered from the arm swelling and malaise and all of the pt's other "symptoms" resolved after 3-4 days. Addtl info is not expected. Of note, the pt reported that the vaccine was administered and symptoms began on 3/7/01 rather than 3/6/01 as reported by MD. Y 03/06/2001 03/06/2001 0 PVT OTH Alphagan, Cosopt, Acular, Altace Codeine allergy; dust allergy; glaucoma; hypertension; mold allergy; sulfa allergy WAES01031448 1
0174257 08/07/2001 IA 64.0 64 F 07/30/2001 On 12/8/00, pt experienced local erythema and induration at site of injection. Addtl info is not expected. Pt had recvd first dose of pneumococcal vaccine 23 polyvalent on 10/20/99. Y U 12/07/2000 12/08/2000 1 UNK UNK UNK UNK WAES01031744 1
0174258 08/07/2001 NY 68.0 F 07/30/2001 On 3/14/01 pt was seen for "cellulitis below the deltoid injection site." It was reported that the pt was started on cephalexin (Keflex) 250mg qid. The total dose was not available. On 3/17/01, pt was seen and improvement was noted. Another pt (WAES 01033128) who recvd the same vax with the same lot # had a similar experience. Addtl info has been requested. Y N 03/12/2001 03/14/2001 2 OTH OTH UNK UNK WAES01032345 1
0174259 08/07/2001 39.0 39 F 07/30/2001 Fifteen minutes post vax, pt developed redness at the site of injection which was reported as about 2" in diameter. The pt sought unspecified medical attention. Addtl info has been requested. Y U 03/20/2001 03/20/2001 0 OTH OTH Azmacort, Intal, albuterol Asthma, meperidine allergy, morphine allergy, steroid allergy WAES01032447 1
0174260 08/07/2001 MA 41.0 U 07/30/2001 Pt recvd pneumococcal vaccine 23 polyvalent (lot # 1531J or 0677K) and subsequently tested negative for antibodies. The reporter was wondering if there had been "any reports of subpotency with these lots." The records of testing prior to release of lots 0677K and 1531J have been checked by Biological Quality Assurance and found to be satisfactory. Lot #s 0677K and 1531J comply with the standards of the Center for Biologics Evaluation and Research and were released. Unspecified medical attention was sought. Addtl info has been requested. Y U Diagnostic laboratory-negative for antibodies UNK UNK UNK UNK WAES01032879 1
0174261 08/07/2001 MA 51.0 U 07/30/2001 Pt was vaccinated with pneumococcal vaccine 23 polyvalent (lot # 1531J or 0677K). Subsequently the pt tested negative for antibodies. The reporter was wondering if there have been "any reports of subpotency with these lots." The records of testing prior to release of lots 0677K and 1531J have been checked by Biological Quality Assurance and found to be satisfactory. Lot 0677K and 1531J comply with the standards of the Center for Biologics Evaluation and Research and were released. Unspecified medical attention was sought. Addtl info has been requested. Y U Diagnostic laboratory-negative for antibodies UNK UNK UNK UNK WAES01033098 1
0174262 08/07/2001 NY 50.0 M 07/30/2001 On 3/19/01, pt was seen for an injection site reaction. It was reported that no medication was ordered. Unspecified medical attention was sought. Another pt (WAES 01032345) who recvd same vax with same lot # had a similar experience. Addtl info has been requested. Y U 03/16/2001 03/19/2001 3 OTH OTH UNK UNK WAES01033128 1
0174263 08/07/2001 OK 7.0 M 07/30/2001 One week post vax, pt developed urticaria and headache. Unspecified medical attention was sought. No further info is available. Y U OTH OTH Bromfenex Allergy to cephalosporin WAES01034262 1
0174264 08/07/2001 NJ 39.0 39 F 07/30/2001 Information has been received from a health professional concerning a patient who stated she had received a dose of pneumococcal vaccine 23 polyvalent in February 2001, when she received her tuberculin purified protein derivative, however nothing was documented in the chart about the patient receiving pneumococcal vaccine 23 polyvanet in February 2001. On 03/27/2001 the patient was vaccinated with a dose, presumably the second dose of pneumococcal vaccine 23 polyvalent. On 03/28/2001 the patient experienced swelling and redness of the upper arm. The patient was given prednisone and Benadryl and recovered. Additional information is not expected. Y Y 03/27/2001 03/28/2001 1 UNK UNK Tuberculin purified protein UNK WAES01034371 1
0174265 08/07/2001 NY 40.0 M 07/30/2001 On approximately 03/20/2001 the patient experienced redness and swelling at the injection site. Subsequently, the patient recovered from redness at the injection site. Subsequently, the patient recovered from redness at the injection site and swelling at the injection site up to the neck. On approximately on 04/02/2001 the patient recovered. Additional information has been requested. Y 03/20/2001 03/20/2001 0 OTH OTH UNK UNK WAES01041071 1
0174266 08/07/2001 OK U 07/30/2001 Information has been received from an office manager at a physician's office concerning "as many as" seven patients who in 2001 were vaccinated with pneumococcal vaccine 23 polyvalent. The patients experienced redness, swelling/edema and warmth at the injection sites and localized joint pain. No further details were provided. Unspecified medical attention was sought. Additional information has been requested. Y U OTH OTH UNK UNK WAES01042035 1
0174267 08/07/2001 NJ 76.0 76 F 07/30/2001 Information has beenreceived from a physician concerning a 76 year old female patient with "tetanus shot" allergy (rash) who on 04/27/01 at 11:00 was vaccinated in the left deltoid with the first dose of pneumococcal vaccine 23 polyvalent (lot 635892/1197K). Concomitant therapy included alendronate sodium and celecoxib (Celebrex). On 04/17/01, as soon as the patient left her physician's offices, the injection site became swollen, red and itchy. This feeling spread to her inner arm and elbow and her arm became painful to the touch and yellow in color. Subsequently, the patient's arm felt better but was still a little swollen. Thepatient did not seek medical attention. No further infotrmation is available N 04/27/2001 04/27/2001 0 PVT OTH Fosamax; Celebrex; Tetanus toxoid allergy WAES01050182 1
0174268 08/07/2001 OH 29.0 29 F 07/30/2001 Post vax, in 2001 the patient experienced severe arm soreness which resolved within 2 days. The medical assistant also reported that 2 other patients experienced adverse events after being vaccinated with the pneumococcal vaccine 23 polyvalen. Additional information has been requested. Y 04/02/2001 OTH OTH Avonex Drug allergy; multiple sclerosis; penicillin allergy; sulfa allergy; WAES01050445 1
0174269 08/07/2001 OH 43.0 43 M 07/30/2001 In May 2001, the patient experienced severe arm soreness and general weakness. Subsequently, the patient recovered within 2 days. Additional information has been requested. The medical assistant also reported on 2 additional patients, one patient experienced injection site swelling and redness and cellulitis and the other patient experienced severe arm soreness. Y 05/02/2001 05/03/2001 1 UNK UNK Vicodin tablets; percocet; methadone hydrochloride; UNK WAES01050893 1
0174270 08/07/2001 RI 78.0 78 F 07/30/2001 On 05/03/2001 the patient experienced redness and warmth at the injection site. The patient went to the local emergency room and was treated with antibiotics. Additional information has been requested. Y U 05/03/2001 05/03/2001 0 UNK UNK UNK UNK WAES01050990 1
0174271 08/07/2001 CA 57.0 F 07/30/2001 The morning following vaccination, the patient experienced a worsening "high" fever, pain and swelling in the arm where she was injected. It was indicated that the patient had sought medical attention. The patient's experiences persisted for 10 days. Additional information has been requested. Y U NONE UNK UNK Combivent; Flovent; Provera; Aciphex, Urso; fever Ceclor allergy; allergy; penicillin allergy; sulfa allergy; WAES01052216 1
0174272 08/07/2001 91.0 F 07/30/2001 Post vax, on 05/23/2001 the patient now has symptoms of a sore left arm and fever of 101F. The patient sought unspecified medical attention. Additional information has been requested. Y U 05/23/2001 OTH OTH UNK UNK WAES01052294 1
0174273 08/07/2001 FL U 07/30/2001 Information has been received from a LPN concerning a few patients who were vaccinated with pneumococcal vaccine 23 polyvalent. Subsequently the patients experienced injection site reactions, injection site redness, hotness at injection site, injection site inflammed and pain at the injection site. The patient sought medical attention. Additional information has been requested. Y U UNK UNK UNK UNK WAES01052853 1
0174017 08/08/2001 MA 3.0 3 M 08/06/2001 A mother reported that her 3 year old son received his 1st dose of Prevnar on 7/11/01 and developed an injection site reaction characterized by redness and swelling. These symptoms resolved. Her son subsequently, developed "facial swelling or angioedema" which persisted at the date of the report. This event was considered "Medically Important". No further information was available at the date of the report. U 07/11/2001 UNK PVT OTH NONE NONE UNK HQ4060803AUG2001 1
0174018 08/08/2001 TX 16.0 16 F 07/30/2001 Severe vertigo, headache for 2 weeks. Headache persisted and was recurrent for about 2 months. It was bad enough to miss school over 6 weeks. I hope there is no residual problem. Per annual report-She got better after 2 months. But she no longer function at schol. Poor memory. Poor concentration. Chronic daily headache and dizziness. Y Y Y 03/31/2001 04/02/2001 2 Spinal Tap done after about 7 weeks of headache; preliminary was negative; Cat Scan and MRI of brain was negative. OTH PVT NONE NONE Allergic rhinitis, food allergy (seafood). 1
0174019 08/08/2001 TN 1.5 1 .4 M 06/11/2001 On 3/10/97, pt had a fever of 104.4F and started within an hour of administration. He was lifeless, no body movement, limp, no response to any activity (such as his name). No seizure or convulsing of any type. Right leg where shot was given, was hot to touch for several hours. From 3/10/97, he lost speech, eye contact, response to name, etc. Has been dx'd with autism. Doc 204502, 60-Day follow up states the followings: No speech, no distinguishable language, constant supervision, requires one on one assistance. Before vaccine, patient could speak words. After the vaccination, he gets no response to verbal communication or eye contact. Follow up information received 09/18/02 states "(The child) has not recovered from this event, He is now labeled autistic, He has no speech and has to have 24 hours 7 days a week adult supervision. My child was a normal, healthy, little boy until the date the vaccine was given. He regressed so fast it was unbelieverable. His regression which included speech, which he has not gained any to this day, eye contact, normal body function,bowel movement, etc,and repetious behavior all started after his vaccine was administered on this date above. The annual follow-up states "pt has not recovered from this event, he is now labeled autistic, he has no speech and has to have 24 hour 7 days a week adult supervision. My child was a normal, healthy little boy until the date the vaccine was given-he regressed so fast it was unbelievable. His regression which included speech, which he has not gained any to this day, eye contact, normal bodily functions, bowel movement, etc. and repetitious behavior all started after his vaccine was administered on this date above." Y Y N 03/10/1997 03/10/1997 0 MRI; EEG; Genetic testing-all nml PUB PVT NKA 1
0174020 08/08/2001 NJ 0.2 0 .2 M 08/01/2001 Pt found in crib, cyanotic, limp and unresponsive. Apparent seizure or choking episode. Remained cyanotic until placed on O2 by EMS. Taken to ER. Y Y Y 2 Y 07/23/2001 07/26/2001 3 Echo; Holter monitor (pending); Spinal Tap; EKG; EEG; CT-all nml PVT PVT NONE NONE NONE 1
0174021 08/08/2001 IL 4.0 4 M 08/01/2001 Pt received immunizations on 7/26/01. Parents phoned our on call MD at 20:30 on 7/27/01 with complaint of a 4 X 4 area of redness on right thigh. Declined to go to ER at that time. Went to ER at 23:30. ER wanted to admit him and parents refused. Was admitted later to a hospital with fever. Given IV Unasyn. Discharged home on oral Augmentin. Dx'd with cellulitis. Y 1 Y 07/26/2001 07/27/2001 1 CBC-increased WBC; CBC and blood cultures-neg PVT PVT Ocuflox eye drops Conjunctivitis NONE 1
0174022 08/08/2001 MI 2.0 2 .0 F In the night, pt was whining and had a fever. The next morning, she stopped breathing and turned blue. CPR and was rushed to a nearby doctor's office. She has epilepsy. Y Y N 05/07/1986 05/08/1986 1 PVT UNK Ear infection NONE 1
0174023 08/08/2001 AK 0.8 0 .9 F 06/28/2001 Started soon after IZ, as small red dots all over body at site of IZ. Then progressed, the next day, to larger red areas (nickel-sized) raised and hard. Mom reported not very itchy. Called pt 3 days later and mom stated was improving. Y 06/25/2001 06/25/2001 0 PUB PUB NONE AK200143 1
0174024 08/08/2001 MI 0.8 0 .9 M 08/03/2001 Pt received Prevnar along with DTAP, Hib and IPV at 10:30 on 7/31/01 and within 2-3 hours, had a fever to 103F. Subsequently, it increased to 104F and decreased with Tylenol. Resolved over the next 48 hours. Y 07/31/2001 07/31/2001 0 NONE PVT PUB GERD 1
0174025 08/08/2001 AK 0.4 0 .3 F 07/10/2001 2 days, post vax, pt had pink, raised rash starting at forehead and covering body. Temperature was 104F for 4 days. Y Y 03/30/2001 04/01/2001 2 PVT OTH Eczema AK200147 1
0174026 08/08/2001 TX 3.0 3 F 06/21/2001 Shot site on right deltoid with 5cm to 6cm erythematous area with erythema progressing toward axillary area in large (Y) configuration. It looked like marks produced by vaccine. Pt had been held while watching mother. Erythema faded in 4-5 days. Y 06/15/2001 06/16/2001 1 NONE PVT PVT NONE NONE NONE 1
0174027 08/08/2001 OR 1.0 1 .1 F 07/26/2001 One day, post vax, pt developed localized swelling of the leg around vaccine site. Swelling was 8cm in diameter and itchy. Treated with Benadryl. Y U 07/24/2001 07/26/2001 2 NONE PVT PVT NONE Eczema 1
0174028 08/08/2001 CA 4.0 3 M 07/18/2001 Family stated that pt had a "seizure" the afternoon, post vax, and went to ER. After multiple attempts to contact father for records release to get copy of ER visit, there has been no response. Y Y 05/01/2001 05/01/2001 0 UNK PVT UNK PPD/Parkdale/01231P/ID/LA Gastroenteritis the day prior to vaccines. NONE 1
0174029 08/08/2001 ME 15.0 15 F 08/01/2001 Acute allergic reaction with erythema, diffuse rash on face and upper torso. BP-stable; no wheezing, (+) SOB and chest tightness. Y Y 07/18/2001 07/18/2001 0 NONE PVT PVT NONE Status post dog bite NONE 1
0174030 08/08/2001 IL 5.0 5 M 08/01/2001 Mother calls about 45 minutes, post vax, saying that pt had urinary urgency right after getting vaccines then developed drowsiness and a stomach ache. She says he soon became flushed and "like he passed out a little". She says he's rested for 5 minutes and seems himself again. She says he feels fine but has blotches of red, everywhere and feels hot. Advised to call doctor. The doctor advised mom to give pt Benadryl and Motrin. She did this and he was better within 1 hour. Y 08/01/2001 08/01/2001 0 PUB PUB NONE NONE NONE 1
0174031 08/08/2001 MD 1.2 1 .0 M 07/30/2001 Pt had a fever for 1 week, treated with Tylenol. He had a loss of weight and appetite over a period of 6 weeks and loose bowels for 4-5 weeks and he also stopped walking for 2 weeks. Y 05/14/2001 05/15/2001 1 PVT PVT NONE NONE 1
0174032 08/08/2001 TX 4.0 4 F 08/01/2001 Pt developed a warm, red and swollen wheal (3"-5") around site of DTAP injection. Pt complained of pain at site. Signs appeared on 8/1/01. Y 07/31/2001 08/01/2001 1 PVT PUB PPD on 7/31/01/0 previously Irritable bladder NONE 1
0174033 08/08/2001 CA 0.25 0 .3 M 07/30/2001 High-pitched cry with fever and irritable. Consoled after 12 hours. No erythema and normal neuro exam. Observation and supportive care. Dx: Antecedent viral syndrome. Y U 07/27/2001 07/28/2001 1 PVT PVT NONE Viral syndrome NONE 1
0174034 08/08/2001 OH 4.0 4 M 07/31/2001 Pt had a fever of 103F, face swelled on right side of face, and right eye swelled shut. Mom called health dept. Benadryl given. Y 02/12/2001 02/12/2001 0 PUB UNK NONE NONE 1
0174035 08/08/2001 MA 31.0 31 F 07/31/2001 Vaccine given on 6/5/01. On 6/15/01, hives began on right foot. She presented with redness, swelling, pain, itching and heat. Preceded to spread throughout body (hands, feet, arms, legs, torso, neck and head). Seen by MD in ER and was given prednisone and Allegra. Seen again in ER and was given a higher dose of prednisone, Cimetidine and Benadryl. Seen by another MD for asthma and allergies and was Allegra 180mg; Cimetidine 400mg and Zyrtec 10mgs. These medicines finally brought the hive under control. None of the previous medicines had provided much relief. The ER doctor as well as the other doctor provided a dx of urticaria. Y U 06/05/2001 06/15/2001 10 CBC-neg; CXR-neg; Organ function-neg PVT UNK NONE NONE 1
0174036 08/08/2001 DE 1.6 1 .6 M 08/01/2001 Child has history of seizure disorder (1st seizure after prior vaccine). Had seizure within 24 hours of receiving his DT and Hib vaccines. (His Tegretol level was also sub-therapeutic). Mother reported seizure. Pt not seen by a doctor for the event. Y 07/25/2001 07/26/2001 1 Tegretol level 2.6 PVT PUB Tegretol NONE Seizure disorder suspected Seizure~Varicella (Varivax)~1~1.00~In Patient 1
0174037 08/08/2001 NY 18.0 18 M 08/02/2001 Pt had a severe headache, photophobia and vomiting which occurred several hours, post vax. Temperature was 97.8F, "able to miss fever", was toxic looking. Symptomatic treatment with Tylenol prn and rest. Y U 07/30/2001 07/30/2001 0 PVT PVT NONE NONE 1
0174038 08/08/2001 OK 47.0 47 F 08/01/2001 On 7/11/01, presented to ER with complaint of left arm pain and redness. She had previously had TD on 7/9/01 in left arm at 12:40. Dx'd with local medication reaction with secondary cellulitis. Treated with Prednisone 50mg po every day; Keflex 500mg po bid; ibuprofen prn and ice to affected area. On 8/1/01, presented to health office at 13:00 today with complaint of pain in left elbow that radiates to left hand. Noted approx. a 2cm in diameter, hardened area in left arm where pt reports she was given her TD shot. Referred to PCP. Y Y 07/09/2001 07/09/2001 0 NONE PUB PUB Norvasc; Estrogen Needle stick 1
0174039 08/08/2001 AK 46.0 46 F 07/09/2001 On 6/30/01, pt felt light-headed, dizziness and fatigue but was able to work. The next day, 7/1/01, the pt felt light-headed, general malaise and tightening throat but had no SOB. She reported to ER. During walk to the hospital, pt had to stop twice to "rest and regain momentum" secondary to fatigue. Vital signs were stable but the pt was put on oxygen and IV was started and she was given something for dizziness. The dizziness resolved and has not returned. Pt was discharged with acetaminophen and bed rest prescribed, to return to clinic in 2 days. On 7/3/01, the pt had worsened muscle pain and spasms in arms, spine, back and shoulders, worse on the left side. Also had mid-sternum pain sensation to pressure. Methocarbamol was prescribed, 500mg tablets, 2 taken 4 X a day. Pt returned to clinic on 7/9/01 for appt. She reports she is doing better but still with fatigue and dull muscle ache. She had been using her back brace and taking Methocarbamol as needed. She is to return to work 7/10/01. Y N 06/29/2001 06/30/2001 1 CBC and Urine analysis-WNL; serum creatinine lab was run and X-rays of chest and back PUB OTH Move Free (formerly call Pain Free) and an OTC formula of glucosamine and chondroiten Allergy to Tetracycline; pt has a history of chronic muscle pain and spasms in legs AK200146 1
0174040 08/08/2001 HI 36.0 36 F 07/31/2001 Pt developed redness and a lump around injection site; itchiness; no discharge. Y Y 07/27/2001 07/30/2001 3 OTH OTH Laceration to right thumb HI0109 1
0174041 08/08/2001 AK 26.0 26 F 07/02/2001 Pt had severe local reaction involving pain in entire arm. Swelling in upper arm and what looks like small abscess formation at injection site. Swelling and pain improved after 48 hours with massage and some ibuprofen; still with pain, swelling in 2" radius around injection site on day 5. Pain and swelling seems to be improving. U 06/28/2001 06/28/2001 0 PUB PUB Zoloft NONE NONE AK200144 1
0174042 08/08/2001 NJ 4.0 4 F 07/30/2001 Developed hives at neck. The next day, had swollen lips in the AM. No breathing problems. Had tacos with sour cream, lettuce and tomato for dinner before hives developed. Had same meal the next night without symptoms. Hive-like rash was seen on exam of left thigh but otherwise a normal exam by 6/30/01 PM. Y Y 06/27/2001 06/29/2001 2 NONE PVT PVT Seasonal allergies, RAD (mild) 1
0174043 08/08/2001 PA 1.25 1 .3 F 08/07/2001 Pt received MMR on 7/20/01 and came to ER on 8/6/01 with a temperature of 105F and a seizure. Y U 07/30/2001 08/06/2001 7 PVT UNK Zantac; Reglan Apnea of prematurity; anemia of prematurity (31 weeks gestation); Reflux and pt is a triplet. 1
0174044 08/08/2001 IN 8.0 8 F 07/27/2001 Pt developed scattered papular, red rash on trunk; no pruritus and afebrile. First appeared PM of 7/26/01. Active child. Currently still has rash. N 07/24/2001 07/26/2001 2 PVT PUB NONE 1
0174045 08/08/2001 NY 0.2 0 .2 M 07/18/2001 Pt experienced allergic reaction to Pertussis. Exhibited by persistent crying that started with immunization administration. Sent to ER. Y Y 07/11/2001 07/11/2001 0 OTH PUB NONE NONE NONE 1
0174046 08/08/2001 VA 1.25 1 .3 M 07/31/2001 On 7/23/01, pt had rash on left arm and left foot. Seen in ER. No fever. He was given Benadryl by ER doctor. On 7/30/01, pt had a fine rash on his trunk and a fever. On 7/31/01, temperature normal. Rash on arm and foot is better today. Y 07/20/2001 07/23/2001 3 PUB PUB NONE NONE NONE 1
0174094 08/09/2001 NY 0.54 0 .5 F 08/07/2001 A mother reported that her 6 month old daughter received her 1st dose of Prevnar and 2nd doses of Hib-Titer, Hep-B and DTAP vaccines on 7/23/01. On 7/27/01, she developed intermittent rapid eye movement. She was seen by the physician. A computerized tomogram was reportedly unusual. On 7/28/01, she was hospitalized. The results of an MRI, EEG and Abdominal Scan are pending. On 7/30/01, she was discharged. Abnormal eye movements. A mother reported that her 6-month-old daughter received her first dose of PREVENAR, and third doses of HIB-titer, Hepatitis B (manufacturer unknown), and DTaP (manufacturer unknown) vaccines on 23-JUL-2001. On 27-JUL-2001, she developed intermittent rapid eye movement. She was seen by the physician. A computerized tomogram was reportedly unusual. On 28-JUL-2001, she was hospitalized. The results of an MRI, EEG, and Abdominal scan are pending. On 30-JUL-2001, she was discharged. Y Y 3 U 07/23/2001 07/27/2001 4 Computerized tomogram-reportedly unusual PVT PVT NONE NONE UNK HQ4136406AUG2001 1
0174095 08/09/2001 NJ 18.0 F 08/06/2001 From telephone contact with reporter, it was stated that an 18 year old female pt received a Menomune A/C/Y/M-135 vaccination on 7/26/01. On 7/30/01, the pt developed backache and headache. On 8/1/01, the pt developed headache, backache and nausea. On 8/2/01, the pt went to a pediatrician's office; at 14:00, pt was violently throwing up. Pt was admitted to the hospital on 8/3/01 and dx'd with viral meningitis. Pt was released on 8/4/01. From FOLLOW-UP correspondence received on 11/02/2001, it was reported that the patient recovered from this experience. Additional patient vaccine, the correct adverse event onset date and responsible physcian information was also proivided. This case is closed. Y 2 U 07/26/2001 07/30/2001 4 UNK UNK U2001009140 1
0174099 08/09/2001 AK 12.0 12 M 07/09/2001 The pt was discovered collapsed, cyanotic, and not breathing approximately 8 hours post vax. Diagnosed with inducible polymorphic ventricular tachycardia Y Y 4 Y 07/03/2001 07/03/2001 0 PVT PUB NONE soto syndrome, pulmonary atresia, hypoplastic right ventricle AK200145 1
0174100 08/09/2001 CT 0.2 0 .2 M 08/08/2001 Pt developed hives, within 48 hours, post vax. He was seen in ER. Per mother, no treatment was given. Y Y 05/08/2001 05/09/2001 1 NONE PVT PUB NONE NONE NONE 1
0174101 08/09/2001 CA 1.0 0 1 M 08/02/2001 Received Prevnar #1 on 7/25/01. Parents say fever developed the same day and has persisted. A rash started, 2 days later, a papular rash especially on chest and abdomen. On exam, no other source of fever found. Parents gave Tylenol and Benadryl. Rx'd on 7/30/01 with Atarax syrup. Y Y 07/05/2001 07/05/2001 0 PVT PVT NONE NONE 1
0174102 08/09/2001 NC 0.2 0 .2 M 07/31/2001 Pt had a swollen RLE ,per mom, with "blotchness" approx. 7 hours, post vax. No fever. Gave Tylenol and Benadryl. On exam, 30 hours, post vax, no swelling detected. No reaction at injection site. Had petechial rash on entire RLE, distal to injection site. Otherwise normal exam. Y Y 07/30/2001 07/30/2001 0 CBC-nml platelet count PVT PVT NONE NONE NONE NC01065 1
0174103 08/09/2001 ME 1.5 1 .5 M 08/01/2001 Increased temperature to 101F on the evening of 7/30/01. On 7/31/01, pt was fussy and had abdominal cramps since 08:00. Doubles over with pain; loose BM; vomited X 2; right arm was red (size of baseball, per mom). The pt temperature was 99.9F, using Tylenol and Mylicon. On 8/1/01, pt was much better. There was no temperature but arm still red. Y 07/30/2001 07/30/2001 0 NONE PVT PUB Zyrtec prn Rhinorrhea and cough RAD 1
0174104 08/09/2001 NC 0.3 0 .3 M 05/11/2001 Mother describes the onset of rash as gradual, over 2 days. Child has also had fevers up to 101F. MD described rash as fine and red, covering face, torso and arms. Fever was treated with Tylenol. Rash was treated with Benadryl. Y Y 02/21/2001 02/23/2001 2 NONE PVT PUB NONE Cold symptoms NONE 1
0174105 08/09/2001 NC 1.0 1 .0 F 07/27/2001 Localized redness at injection site, palpable knot which measures 3cm X 2cm, red but no warmth to touch and no induration or streaks. Outline drawn and to observe. Y 07/25/2001 07/26/2001 1 PVT PUB NC01066 1
0174106 08/09/2001 NC 0.3 0 .3 F 08/01/2001 Pt developed fever, "funny breathing", and was seen in ER the following day, post vax. Pt was given Rocephin 500mg and dx'd as viral syndrome. Y Y 04/20/2001 04/21/2001 1 RSV swab; CBC with/diff; Panel 7; CXR; Blood cultures PVT PUB NONE NONE Tracheomalacia; GERD NC01067 1
0174107 08/09/2001 OR 2.08 2 .1 M 07/31/2001 On 7/31/01, telephone call reported, red and warm area on right upper arm (1st report per mom). On 8/1/01, follow-up telephone call, pt has a red circle around point of injection with solid bumps (small), 1 1/2" around from back of child's right arm. Pt is acting good. No temperature and improving daily. Y 07/23/2001 07/28/2001 5 PUB PUB NONE NONE NONE 1
0174108 08/09/2001 MI 1.6 1 .2 M 08/04/2001 Prolonged and extreme hives for 1 month which required 2 trips to ER. Oral and shot steroids, allergy testing, doctor visits and 3 prescriptions. Y Y 03/21/2001 04/04/2001 14 PVT PVT NONE NONE 1
0174109 08/09/2001 GU 38.0 38 M 07/30/2001 Pt developed hives over trunk and extremities. Treated with Allegra 180mg X 1. This medicine was not effective and the hives resolved in 5 days. Y Y 07/19/2001 07/27/2001 8 NONE MIL MIL NONE NONE NONE 1
0174110 08/09/2001 MN 3.0 4 F 08/02/2001 Post vax, pt had an adverse reaction. Left arm was swollen 5cm X 5cm with a greenish color; fever of 103.9F X 4 days. Y Y 07/25/2001 07/30/2001 5 PVT OTH NONE NONE NONE 1
0174111 08/09/2001 TX 5.0 5 F 07/31/2001 At the site of the injection for IPV, it was hard, red, swollen and blistered. Pt complained of itching at site. Dx'd at ER as allergic reaction to vaccine. Y Y 07/26/2001 07/27/2001 1 PUB UNK PPD skin test/Aventis Pasteur/C0153AA/ID/LA/0 previously NONE NONE 1
0174112 08/09/2001 CA 4.2 4 F 08/02/2001 Pt's left deltoid with edematous, erythemic area surrounding the injection site. U 07/31/2001 NONE PVT PVT NONE NONE Newly dx'd heart murmur 1
0174113 08/09/2001 GU 1.0 1 .0 F 07/23/2001 On 7/20/01, 9 days after MMR, Varicella, IPV and Hep-B vaccines were given, pt had (+) erythematous multiple macular papules with some confluent all over the body with fever for 5 days. Fever went up to 102F and pt was fussy. Measles-like reaction. Y 07/11/2001 07/20/2001 9 7/23/01-Rubeola IgM 1:20 (high) PVT PVT More than 2 weeks of nasal discharge; Sinusitis Also reported before for rashes probably due to shots given on 1/10/01. Rashes~Pneumo (Prevnar)~1~0.75~In Patient 1
0174114 08/09/2001 GU 0.5 0 .5 F 01/02/2001 6 days, post vax, pt developed multiple erythematous, slightly hard and raised, macular rash on the right upper extremity. Rashes have pin-point, dry papules in the meddle. This was noted also at 4 months old, 6 days, post vaccinations. Y 01/03/2001 01/09/2001 6 NONE PVT PVT NONE 1
0174115 08/09/2001 TX 4.0 4 M 08/01/2001 Pt developed a red and swollen left and right leg. No appetite, fever of 100.5F, left leg skin peeling and (3cm induration). Went to ER. Y N 07/30/2001 07/31/2001 1 PUB PUB NONE NONE NONE 1
0174116 08/09/2001 NC 0.2 0 .2 M 07/23/2001 Child received routine vaccinations on 4/4/01. Seen in ER on 4/6/01 with symmetrical dry rashes on the outer aspects of lower extremities; fever (98.8F on Tylenol); and listlessness. Y Y 04/04/2001 04/04/2001 0 NONE PVT OTH Tylenol for fever NONE Acid Reflux 1
0174117 08/09/2001 OH 32.0 32 F 07/30/2001 For 2 days, pt had pain at the injection site, then stiffness in the arm, left neck and left back with triggered a migraine. U 07/25/2001 07/27/2001 2 PVT PVT Claritin Puncture wound of foot Aspirin and Ceclor allergies Tired, swollen, headache X 1 week~Td Adsorbed (no brand name)~~20.00~In Patient 1
0174134 08/10/2001 TN 0.6 0 .6 M 07/24/2001 Child had intracranial cysts dx'd on 2/14/01. Child received vaccines 3 days before death, which was noted as asphyxia death (facial compression), face down sleeping position in bed with mother. Office felt this should be reported. Death certificate and autopsy reports states cause of death to be positional asphyxia. Y 03/24/2001 N 03/21/2001 03/24/2001 3 PVT OTH NONE recent pulmonary congestion and questionable ear infection Intracranial cysts TN01035 1
0174135 08/10/2001 TN 0.25 0 .2 M 07/23/2001 On 7/18/01 at 04:30, infant was found by mother, not breathing. She had checked on twins at 01:30 and both were fine. Father called 911, while mother initiated CPR. Baby was DOA at ER. Autopsy findings report: proximate cause of death to be sever infectious process of perianal nd perineal area; immediate cause of death atelectasis and pulmonary edema; mechanism of death aspiration asphyxia with pulmonary inadequacy. Y 07/18/2001 N 07/12/2001 07/18/2001 6 PUB PUB NONE NONE TN01032 1
0174143 08/10/2001 WV 41.0 41 F 08/03/2001 On 11/20/00, pt had upper respiratory infection associated with cough, sore throat, wheezing, low-grade temperature and chills with profuse sweating. She kept getting worse and was hospitalized on 12/29/00. On 1/25/00, she had numbness in hands and feet, trouble walking, drooping on the left side of face with slurred speech, asymmetric smile, numb tongue, blurred vision and trouble with eyelids. She was hospitalized and put on IVIG for 5 days. She is still recovering and taking physical therapy. The follow up states that: I have permanent facila damage (the left side of my face does not move); have visual problems; hand, feet and legs still go numb; also still have lung problems. This shot has left me physically and mentally impaired. Y Y Y 10 Y N 11/09/2000 11/20/2000 11 Lumbar Puncture PVT UNK Coated aspirin; Lotrel; Paxil; vitamin E Coronary anomaly 1
0174144 08/10/2001 VA 1.6 1 .7 F 08/03/2001 Fever to 102.3F and a seizure (generalized), lasting approx. 25 minutes with hypoxia (brief). Y Y 2 Y 07/31/2001 08/01/2001 1 Head CT-nml; Urine & Blood cultures-neg; EEG-nml except for generalized slowing PVT PVT NONE NONE NONE 1
0174145 08/10/2001 IL 33.0 F 07/27/2001 Y Y 07/24/2001 UNK UNK States she has fibromyalgia. 1
0174146 08/10/2001 NY 1.0 0 .8 M 07/11/2001 Pt had heavy urination, vomiting, loss of weight (over night), slight fever and loss of sleep, as well as, dehydration, 2 weeks after the 3rd shot of Hep-B in the series. Diagnosed with diabetes. Y 5 N 04/04/2001 04/16/2001 12 PVT UNK diabetes 1
0174147 08/10/2001 OH 60.0 59 M 07/31/2001 Left shoulder began swelling and became sore, the day after injection. Went to ER on 7/11/01 and was given IV antibiotics. Swelling increased to 2 X natural shoulder size. Admitted to hospital on 7/13/01 and discharged on 7/14/01 with a dx of "infection" (cellulitis). They treated it with antibiotics. No further complications and has apparently fully recovered. Y Y 2 Y 07/09/2001 07/10/2001 1 MRI and CT Scan of left shoulder to determine if abscessed-none detected. No drainage needed. PUB PUB NONE Stepped on a nail OH0047 1
0174148 08/10/2001 GA 1.6 1 .5 M 07/18/2001 The pt experienced a right leg that is puffy and swollen at injection site denies any fever or itching. The pt also has redness around the left arm injection site. Y 07/17/2001 07/18/2001 1 NONE PUB PUB NONE NONE NONE GA01072 1
0174149 08/10/2001 GA 1.2 1 .2 M 06/28/2001 The pt experienced a rash with a small red slightly raised bumps to face, trunk, upper and lower ext. Mostly on back. Denies fever or obvious pruritis. Y 06/19/2001 06/28/2001 9 NONE PUB PUB NONE NONE GA01063 1
0174150 08/10/2001 PA 1.7 M 08/09/2001 Pt developed fever, vomiting and diarrhea from 3/2/01 to 3/3/01. Y 03/02/2001 NONE PVT OTH NONE NONE NONE 1
0174151 08/10/2001 PA 0.4 M 08/09/2001 Cough and congestion U 06/04/2001 NONE PVT UNK Paregoric; Promethazine with DM; Occuflox GTTS NONE NONE 1
0174152 08/10/2001 NY 1.0 1 .2 F 08/06/2001 On 7/25/01, MMR and Varivax given. Returned on 8/4/01 with localized erythema and edema at Varivax site. Pt had facial and trunk rash, conjunctivitis and red throat (looked like measles). U 07/25/2001 08/04/2001 10 NONE PVT UNK NONE 1
0174153 08/10/2001 DC 3.0 3 F 06/12/2001 The pt developed an erythematous left injection site, was tender to touch and also experienced hives. Treated with warm compresses. Y Y 04/17/2001 04/19/2001 2 NONE PUB PUB NONE NONE NONE 1
0174154 08/10/2001 KY 0.8 0 .1 M 08/06/2001 Following the last 2 doses of Prevnar, a few days later the pt experienced wheezing and respiratory distress. Y 12/08/2000 12/10/2000 2 PVT UNK NONE eczema NONE 1
0174155 08/10/2001 GA 1.0 1 .0 M 08/06/2001 The morning following the vax, the pt experienced a fever. The fever lasted 3 days. The pt then developed a non-pruritic rash as fever broke 5 days post vax. Y 07/30/2001 07/31/2001 1 PVT PVT NONE NONE 1
0174156 08/10/2001 NY 57.0 57 F 07/30/2001 The pt experienced hot, cold, weakness, dizziness, blacked out on floor and nausea. Y N 07/24/2001 07/24/2001 0 PVT PVT NONE NONE 1
0174157 08/10/2001 PA 51.0 51 F 07/25/2001 Six days post vax, the pt experienced a fever, headache, severe joint pains and flu like symptoms. Y U 06/29/2001 07/05/2001 6 NONE PVT PVT Vivelle NONE NONE 1
0174158 08/10/2001 DC 25.0 25 M 07/20/2001 Pt complained of lower lip swelling and welts over trunk, arms, legs and face with itching. Pt had a similar reaction but only worse, post vax rabies vaccine. Y 07/04/2001 07/05/2001 1 NONE OTH PUB NONE Allergy to PCN 1
0174159 08/10/2001 SC 2.0 2 .1 F 08/07/2001 Pt developed a blotchy-type rash all over her body which appeared a couple of days, post vax. Treated with Benadryl and instructed to follow-up if no improvement. Y Y 08/02/2001 08/04/2001 2 PVT PUB Depakote NONE CP; CMV; hydrocephalus and seizures 1
0174160 08/10/2001 PA 6.0 6 M 08/06/2001 Pt developed a papular eruption within 24 hours, post vax, progressive and required systemic prednisone therapy. Y Y 08/01/2001 08/01/2001 0 NONE PVT PVT NONE NONE NONE 1
0174175 08/10/2001 GA 2.0 2 .4 F 07/18/2001 15mm X 16mm whelp with surrounding left arm area of redness 20 X 20 observed 15mg increased only slights to stated size. Advised to use liquid Benadryl as directed and hydrocortisone cream. Called on 7/19/01 and no answer. Mother phoned and said all resolved and child is fine. Y 07/18/2001 07/18/2001 0 NONE PUB PUB NONE NONE NONE GA01071 1
0174176 08/10/2001 GA 18.0 17 F 07/24/2001 Pt developed increased swelling and redness in left arm from shoulder to elbow the day after TD vaccine. She was unable to move her arm due to soreness. She took Benadryl. She still has a hard knot at injection site but swelling has decreased, after 6 days. Y 07/06/2001 07/07/2001 1 NONE PUB PUB NONE NONE Unspecified adverse event~Pertussis (no brand name)~1~1.50~In Patient GA01070 1
0174177 08/10/2001 GA 4.0 4 M 07/25/2001 Pt developed a rash and was seen by a doctor in a children's clinic. Mom reported allergic reaction to Varicella #2 dose. Doctor's notes indicated Rx. Phone call on 7/30/01; child is fine. Y Y 07/10/2001 07/13/2001 3 PUB PUB NONE NONE GA01069 1
0174178 08/10/2001 GA 6.0 6 F 07/12/2001 On 7/11/01 at 21:00, pt had a fever of 101F and vomited. On 7/12/01 AM, pt had a fever of 101F, swelling of face and hives on face. The pt also, complained of a sore throat. Pt was seen by ER physician at 15:00 on 7/12/01 and he said that the pt had fluid in ears and tonsillitis. Antibiotics were given. Y Y 07/11/2001 07/11/2001 0 NONE PUB PUB NONE NONE NONE GA01064 1
0174179 08/10/2001 GA 1.0 1 .0 M 07/10/2001 Per mom; 12 days, post vax, she noticed a knot on pt's right leg, where he got a shot. She states the pt seems to favor this leg slightly and has fallen a couple of times secondary to this leg buckling. Advised mom to apply moist heat to area and call HD in 1 week with changes. U 06/25/2001 07/07/2001 12 NONE PUB PUB NONE NONE NONE GA01067 1
0174180 08/10/2001 GA 5.0 5 M 07/24/2001 Pt developed redness and induration at the site of DTAP injection, 20 hours, post vax. He was seen at youth care on 7/20/01. No Rx. Advised Tylenol. On 7/23/01, had an area of redness increasing to 9cm and a rash of red bumps appeared under arm and left side of face. He was seen at youth care and advised it was a reaction to the pertussis. He was given: Oropred, Cephalexin and Hydroxyz HCL. Y Y 07/18/2001 07/20/2001 2 PUB PUB NONE NONE NONE ~DTaP (no brand name)~1~0.20~In Sibling|~DTP (no brand name)~~0.00~In Sibling GA01066 1
0174181 08/10/2001 GA 1.7 1 .7 F 07/13/2001 Pt was contacted today by MD from hospital and the pt arrived about 1 hour earlier today after having a seizure. Says temperature is 102F (rectally) and says she has no rash, whelps, difficulty with respirations. No signs of allergic reactions and says believes temperature went up so fast as to cause seizure and that the child's dad had febrile seizures as a child. Says child seems fine now; and is to be discharged to mother's care. Y Y 07/12/2001 07/13/2001 1 CBC-WNL PUB PUB NONE NONE NONE GA01065 1
0174182 08/10/2001 GA 2.0 2 .7 M 07/26/2001 When client got up the next morning, his left hip, thigh and knee cap were swollen twice the normal size and slightly warm. Mother put cool packs and has been giving salt water baths to decrease swelling. They state no change in swelling. Client has not complained of pain unless someone is pushing on area. Pt went to clinic and they stated it was a counter reaction to pertussis that led to the edema. Recommended DT in the future. Y 07/02/2001 07/03/2001 1 PUB PUB NONE NONE NONE GA01062 1
0174183 08/10/2001 TN 4.0 4 M 08/01/2001 Pt's left deltoid was swollen, hot and red from elbow to shoulder. He had a yellow scab noted at injection site. Complained of soreness and pain at site, also. Is well other than "local reaction". Referred to MD. Y U 07/30/2001 07/31/2001 1 PUB PUB NONE NONE NONE TN01036 1
0174184 08/10/2001 TN 1.6 1 .7 F 07/26/2001 Pt went to ER on 7/25/01 AM, due to about a 2" area of redness and swelling to left thigh X 2 days, post vax. Follow up on 10/25/2002: "From follow-up correspondence received on 09/11/01 it was reported the pt developed a 2 inch area of redness not a 72 inch area as previously reported. The redness and swelling of the left thigh lasted for two days after the injection; it did not develop two days after the injection as previously reported. The correct initial for the pt's last was also provided. This case is closed." Y Y 07/23/2001 07/24/2001 1 PVT PVT NONE NONE NONE TN01034 1
0174185 08/10/2001 TN 1.5 1 .5 F 07/26/2001 Left leg red and warm, 6 cm circular erythematous lesion surrounding injection site, no streaking, not tender. Follow up on 10/25/02: "From faxed correspondence from reporting nurse stated that an 18 month old female pt received a Tripedia and an Ipol vaccination on 07/25/01. On 07/26/01 the pt developed an area of redness, warmth, 6-cm erythematous lesions surrounding injection site reaction of Tripedia site. No streaking, no tenderness. The pt reportedly recovered from this experience. From follow up correspondence received on 09/11/01 informationr egarding where the vaccine was purchased and where the pt received the vaccination was provided. No further information is anticipated for this report. This case is closed." Y Y 07/25/2001 07/26/2001 1 PVT PVT Tylenol NONE NONE TN01033 1
0174186 08/10/2001 TN 41.0 41 F 07/23/2001 This client reports swelling and severe aching in the joints of feet knees, hands, wrists, and elbows. Beginning on 07/13/2001 and severe enough on 07/18/01, could hardly walk. She saw a doctor, and had several test. The doctor thought it was a reaction due to the TD vaccine. The client is completely healed on 07/22/01 at church. Y Y 06/21/2001 07/13/2001 22 Blood work - Wnl, Mono strip - Neg, Thyroid - Wnl. PUB PUB NONE Healthy. NONE TN01031 1
0174187 08/10/2001 TX 1.0 1 .0 F 08/06/2001 After infant was given MMR, noted 1 1/2 cm wheal at the site. No other symptoms. Lungs clear, no generalized swelling. Given Benadryl. Wheal resolved in 1 hour. Child had history of eating eggs without problems. Y 06/27/2001 06/27/2001 0 PVT PVT Pediacare infant drops. Runny Nose. 1
0174188 08/10/2001 TX 1.0 0 1 F 08/06/2001 Within minutes of receiving Varivax, it was noted, localized swelling and erythema with wheal formation on the left arm at the site of injection. No other symptoms, lungs clear, no generalized swelling. Treated with Benadryl, within minutes noted decreased erythema but wheal formation still present. Released home, no other symptoms. Y 07/17/2001 07/17/2001 0 PVT PVT NONE 1
0174189 08/10/2001 FL 4.0 54 F 08/03/2001 This child had swelling of the right upper arm, no redness or infection. Advise: warmth and follow up. Y 08/01/2001 08/02/2001 1 PVT UNK Cerebral Palsy, history of seizure disorder, G-tube. 1
0174190 08/10/2001 MN 6.0 5 F 08/06/2001 The mother of this patient thought she needed another Hep B vaccine, she was in with her mother who did need a Hep B. Her chart was not immediately available so the shot was given. Later we found out it wasn't needed. About 2 months later vitiligo lesions started developing, multiple seen at time of evaluation on 07/27/01. U 03/09/2001 05/01/2001 53 (+) FANA @ 1:160 homogeneous on 07/27/01. PVT PVT NONE NONE NONE 1
0174191 08/10/2001 OH 27.0 28 M 07/26/2001 This patient had 2nd Hepatitis B on 07/20/2001. On 07/23/01, he started itching and began noticing blister like skin eruptions, (arms, wrist, ankle, body & legs). He had a similar but milder event after 1st Hepatitis B shot but didn't connect to shot until same symptoms developed following the second shot. No other signs and symptoms. Y 07/20/2001 07/23/2001 3 NONE PUB OTH NONE NONE Hay fever. OH0046 1
0174192 08/10/2001 OH 11.0 11 M 07/24/2001 Thursday, 07/19/01, at 11:30 PM, this patient woke up unable to sleep due to difficulty breathing and wheezing. No history of allergies. He was taken tot he ER, not seen. Brought the child home, given 1 puff of Flovent inhaler at 1:30 AM. Wheezing resolved by 4 AM completely. Also complained of itchy throat at the time of onset. Y 07/11/2001 07/19/2001 8 NONE PUB PUB NONE NONE NONE OH0045 1
0174193 08/10/2001 GA 1.25 1 .3 F 07/26/2001 This infant had cellulitis to the left leg. U 07/24/2001 07/26/2001 2 PVT PUB 1
0174194 08/10/2001 TX 12.0 12 M 08/02/2001 Right deltoid had 50 cent size raised reddened area. 07/14/2000 UNK UNK 1
0174195 08/10/2001 IN 12.0 12 M 08/02/2001 On 07/23/01, not feeling well, no specific symptoms. On 07/24/01, 9 AM, low grade fever, swelling left side parotid area. On 07/25/01, 3 AM, 101.9 fever, golf ball size swelling left parotid area, confused, and hallucinating. Taken to the ER. No meds prescribed. The doctor diagnosed mumps disease, treat symptoms. Recovering. Y U 07/23/2001 07/24/2001 1 No lab work. Strep test throat - Neg. Doctor diagnosed mumps disease per symptoms. PUB PUB NONE NONE NONE IN200112 1
0174196 08/10/2001 TX 4.0 4 F 08/02/2001 ON 08/01/2001, this child woke complaining of pain to injection site to left arm where DTAP was administered. Also complained of stomach hurting, vomiting, through out the day, fever of 102. Motrin was administered at 11:30 PM, the night before diarrhea, had six bowel movements through out the day. Taken to the ER at 8:30 PM, on 08/01/01 was told the child had a reaction to the DTAP vaccine. Y U 07/31/2001 08/01/2001 1 PUB PUB Intal, inhaler, Proventil inhaler. NONE Asthma SA0109 1
0174197 08/10/2001 PA 0.2 0 .2 M 08/09/2001 The pt experienced thrush. Treated with Nystatin. Y Y 04/25/2001 05/04/2001 9 PVT OTH Pediacare, silver nitrate runny nose, cough hyperbilirubinemia, umbilical granuloma 1
0174198 08/10/2001 IN 2.0 2 .4 M 08/07/2001 This child had swelling below injection site to the knee. Tender to touch, slightly red, warm to touch. Patient walking and playing with out complaints. Y Y 07/12/2001 07/13/2001 1 NONE PVT PVT Benadryl NONE Chronic allergy, allergic to eggs. Diarrhea, vomiting, rash. 1
0174199 08/10/2001 IA 4.1 4 F 08/09/2001 The pt was taken to the ER with deltoid swelling to approximately 8 cm, redness, hardness and pain. Was treated and released. Instructed to apply ice and give Motrin every 4 hours for pain. Y Y 08/07/2001 08/08/2001 1 PUB PUB NONE NONE 1
0174200 08/10/2001 NY 54.0 54 M 07/27/2001 The pt's upper arm around injection site became red and inflamed from his shoulder to 2 inches above his elbow. Reaction revolved without need for any treatment after approximately 1 week. Y 06/01/2001 06/02/2001 1 NONE OTH UNK Rispardal, Vitamin B12 injections, Sudafed, Norvasc, Cepacol scratchy throat paranoid schizophrenia, hypertension 1
0174201 08/10/2001 IN 5.0 5 M 08/02/2001 Left leg swollen from knee to upper thigh, swollen twice the size of the other leg. Told to use ice paks and Motrin. Lots of pain and leg warm to touch. Child couldn't walk on leg. 08/02/01, the child was doing better, swelling gone down and the child was walking. They are to continue using ice paks and Motrin. Y U 07/31/2001 08/01/2001 1 NONE PUB PUB NONE NONE IN200111 1
0174163 08/13/2001 AL 14.0 14 F 08/05/2001 Pt had a muscular seizure, approx. 5-10 minutes. EMS came and took her to the ER. Y Y Y 04/10/2001 04/10/2001 0 PUB UNK NONE NONE 1
0174165 08/13/2001 NY 1.25 1 .3 F 08/07/2001 48 hours, post vax, pt awoke crying, inconsolable crying which lasted 2 months. No kidding. Then off and on for months at a time, around the clock. for another year. Now, episodic, lasting weeks. Irritable, depressed. Complete personality change overnight and was a good sleeper, never cried, but now is a depressed child with developed gross motor delays and complaint of fingers hurting her. The annual folow-up states pt "still has bouts of depression and inconsolable crying. Has bouts of easily triggered tantrums. Still has severe gross motor delays. Bouts of insomnia. Gastrointestinal problems i.e. severe bloating. I want to emphasize that none of the above symptoms existed prior to that DTaP vaccine. Approx. 36 hrs after the vaccine, pt awoke crying inconsolably and has never been the same since. This last "bout" of depression and crying lasted 2 months. The G.I. problems and gross motor delays are a constant. The mood issues are episodic." Y N 07/20/1999 07/22/1999 2 PVT UNK INH-was in the 3rd month of a 9 month course fever, staring spells~Polio Virus, Inact. (PolioVax)~1~0.00~In Patient 1
0174166 08/13/2001 NY 2.0 2 .8 F 08/04/2001 Post vax the patient experienced redness, pain and induration of the injection site. Y 08/02/2001 08/02/2001 0 PVT UNK 1
0174167 08/13/2001 NY 0.15 0 .1 F 08/01/2001 Patient's father stated that at 17:00 hours on 07/23/2001 the patient's left thigh was pinkish, swollen and hard to the touch. When the patient's legs were lifted to change a diaper, the patient cried uncontrollably. The patient was treated with Tylenol. On 07/24/2001 at 14:00 hours the patient saw Dr who advised treatment with Motrin. On 07/30/2001 the patient's mother called and stated the patient's left thigh is still reddened, swollen and warm to the touch. The mother was advised to apply cold compresses to the thigh. Follow up on 08/01/2001 the father states the patient is still the same and they have not tried cold compresses, as they feel they will not help. Y 07/23/2001 07/23/2001 0 CBC PUB PUB NONE NONE 1
0174168 08/13/2001 PA 1.6 1 .6 M 08/07/2001 The patient experienced a high fever (102-103F) with nausea and vomiting within 12 hours of vaccine administration. The patient was treated with antipyretics and fluids. Y 03/08/2001 03/08/2001 0 NONE PVT PVT NONE NONE NONE 1
0174169 08/13/2001 OH 2.0 2 .1 M 07/19/2001 Post vax the patient experienced a fever and swelling of the right leg from the injection site to the ankle, and also redness and the development of blisters on that leg. The patient was seen at the ER. Doctors at ER were concerned about possible bug bite. Y U 07/16/2001 07/16/2001 0 PUB PUB NONE NONE UNK 1
0174170 08/13/2001 PA 1.2 1 .3 F 07/19/2001 In the PM on the day of the vaccination, the patient developed an area of redness around the injection site on the left thigh. On 12/19/2000 the patient was seen in the office, with redness at the site, approximately 3 cm area. Doctor believes reaction is from DTaP U 07/17/2001 07/17/2001 0 NONE PVT UNK NONE Meningitis 05/31/2000-06/07/2000 1
0174171 08/13/2001 ID 0.5 0 .5 M 08/16/2001 Post vax the patient was fussy, a fever of 102F, and redness and swelling on the right proximal thigh. Y 08/07/2001 08/07/2001 0 NONE PVT PUB NONE NONE NONE 1
0174172 08/13/2001 MN 53.0 52 M 08/09/2001 The pt received his 1st injection of Lymerix in 5/00. Approx. 1 day, post vax, he experienced general malaise. The malaise resolved after an unspecified period of time. The pt received the 2nd injection of Lymerix in 6/00. In 11/00, approx. 5 months, post vax, left bundle branch block was discovered. The pt was referred to a cardiologist, who confirmed the presence of left bundle branch block of unknown origin. The cardiologist reportedly told the pt that the vaccinee "probably had a virus which settled in (his) heart." However, the pt reported that he "was never sick". The pt underwent an unspecified stress test and angiography in 1/01. The angiogram reportedly "was excellent"; however, the pt stated that a "15 to 20% loss of output" was noted. The cardiologist discontinued pravastatin therapy. As of 7/26/01, the left bundle branch block and reduced cardiac output were ongoing. Left bundle branch block and reduced cardiac output are considered GSK "medically serious". Y N 06/01/2000 11/01/2000 153 ECG-Left bundle branch block in 11/00; Angiogram-"Excellent" OTH OTH Pravachol; Claritin; Nasonex; Pseudoephedrine; multi-vitamins Seasonal allergies (NOS); chronic sinusitis Malaise~Lyme (LYMErix)~1~53.00~In Patient 20010191071 1
0174173 08/13/2001 WI 36.0 36 M 08/16/2001 Post vax, the patient experienced bilateral knee pain, bilateral foot pain and right prepatella effusion. U 06/14/2001 06/21/2001 7 PVT PVT NONE NONE UNK 1
0174174 08/13/2001 AZ 5.0 5 M 08/10/2001 Child dx'd with Hep-A on 8/8/01 by doctor. Y Y 07/24/2001 08/08/2001 15 UNK OTH PUB NONE NONE NONE 1
0174202 08/13/2001 CA 5.0 5 F Pt developed red, swelling in leg, 1 week, post vax, lasting about a week. Y 07/13/2001 07/20/2001 7 PVT PVT NONE Fragile X 1
0174203 08/13/2001 CA 16.0 16 F 08/04/2001 Pt developed shoulder and arm pain requiring X-rays and treatment with 800mg ibuprofen. Y 06/13/2001 06/14/2001 1 X-rays PVT PVT NONE 1
0174204 08/13/2001 VA 1.5 1 .5 F 08/07/2001 Pt received IPV only on 7/25/01 and broke out in a rash on 7/26/01. In for appt on 7/27/01, because no improvement; had urticaria rash. Probable reaction to IPV. Y Y 07/25/2001 07/26/2001 1 CBC done PVT PUB NONE NONE Zithromax causes hives 1
0174205 08/13/2001 WI 1.0 1 .0 F 08/06/2001 Pt had a fever of 103.8F and a flat, red "tiny" rash around her neck for 2-3 days, post vax. Rash spread to abdomen and back but fever disappeared after 2 days. Y 07/23/2001 07/23/2001 0 NONE PVT PVT Motrin NONE NONE 1
0174206 08/13/2001 AR 4.0 4 F 07/02/2001 The following morning, post vax, the pt had swelling and inflammation in right arm. Pt was taken to ER and Rx'd with ice packs to affected arm, Erythometh 200/5mg. Dx'd with local reaction to injection. Y Y 06/28/2001 06/29/2001 1 NONE PUB UNK NONE NONE AR0130 1
0174207 08/13/2001 ID 5.0 5 M 07/30/2001 Injection site was red and swollen the size of an orange and hot and tender to touch. It also itches and "bothers him". Y Y 07/26/2001 07/27/2001 1 NONE PUB PUB NONE High fever~DTaP (no brand name)~1~1.25~In Patient|~Measles + Mumps + Rubella (no brand name)~1~1.25~In Sibling ID01038 1
0174208 08/13/2001 ID 45.0 45 M 07/24/2001 The pt stated that on 6/22/01 he had right side pain, under collar bone and across chest. Saw PMD on 7/1/01 with Rx of anti-inflammatory meds. Saw a chiropractor on 7/5/01 who thought he had a rib out of place. Saw this doctor on 7/11/01 and had a CXR with was normal. Pt states pain has been moving moving around since then, according to his wife on 7/22/01. Y Y 06/21/2001 06/22/2001 1 CXR-nml PUB PVT ID01037 1
0174209 08/13/2001 ID 1.2 1 .2 M 07/20/2001 Pt had a varicella type rash. Will do home care of Tylenol/Advil and Benadryl as needed for itching. Y 07/02/2001 07/16/2001 14 PVT UNK NONE NONE ID01036 1
0174210 08/13/2001 ID 1.3 1 .3 M 07/17/2000 On 7/13/01, mom called concerning a temperature of 100.3F and spots like pimples, on back (4) and has been exposed to chickenpox. On 7/17/01, mom called and the pt had no further spots and temperature stayed the same (100.3F-100.7F) all weekend but is OK now. Y 07/11/2001 07/13/2001 2 PUB UNK NONE NONE ID01035 1
0174211 08/13/2001 FL 4.0 4 M 08/07/2001 Left upper arm with generalized edema, redness and warmth. Y Y 08/03/2001 08/04/2001 1 NONE PVT UNK 1
0174212 08/13/2001 ID 40.0 40 F 07/09/2001 Area swelled up 3"-4" in diameter around injection site with red bump also at injection site. Pt had joint discomfort, bilateral. Symptoms persisted for 4 days with swelling still evident. Y 07/05/2001 07/06/2001 1 NONE PUB PUB NONE NONE NONE ID01034 1
0174213 08/13/2001 MI 13.0 13 M 08/01/2001 Pt developed a rash and hives on face, arms, chest, back and legs. He had numbness and soreness in right arm and right hand, abdominal pain and vomiting. Symptoms developed within 6 hours, post vax. Pt returned to office and received Benadryl 25mg, IM and observed for 1 hour. Symptoms resolved in office. Y Y 07/30/2001 07/30/2001 0 NONE PVT PVT Clonidine 0.1mg for insomnia; Proventil MDI 2 puffs prn wheezing NONE Asthma, ADHD, Sleeping disorder 1
0174214 08/13/2001 OH 6.0 6 M 08/06/2001 Pt developed swelling, erythema and warmth at the site of injection. Reported fever to 104F (orally) with increased diameter of left arm of 1" more than right arm. Y 07/30/2001 07/31/2001 1 PVT PVT NONE NONE Atresia-right ear 1
0174215 08/13/2001 WI 67.0 67 F 08/03/2001 The last week of 12/99, had Christmas family day dinner and afterwards was very ill; headache; fever and blew blood through nose for 2 weeks. Feet were very red and burning for a week. Hot water also turned them very red. Also had a cough and restlessness for 2 weeks. Sore left arm. Prayed to God a lot. Y 12/24/1999 12/25/1999 1 OTH OTH NONE NONE 1
0174216 08/13/2001 OH 12.0 12 M 08/02/2001 Approx. 1 hour and 45 minutes, post vax, mom called to pick child up from school. Child stated that it was "hard to breathe" and he felt "puffed up inside". Felt as if he had just come back in from running. Felt like someone was "sitting on his chest". Mom states, she took child home and called pediatricians office. They advised to give child Benadryl. Repeated Benadryl dose 4 hours after his 1st dose and he recovered by evening. Y 12/05/2000 12/05/2000 0 PUB PUB NONE NONE Allergy to eggs; history of febrile seizures 1
0174274 08/13/2001 WI 1.5 1 .5 M 12/05/2000 Per mom, shots given at 09:30 and pt had chills by 10:30 and was given Tylenol. Pt's temperature was 102F at 13:00 and was given Tylenol. Temperature increased at 16:30, not taken but felt hot, so was given Tylenol. Pt slept until 18:30 and then he awoke and wanted only to be held. He had a seizure at 19:00 and went to ER. Watched at ER and given antipyretics and sent home. Tylenol and ibuprofen at 02:00. He is doing fine today on 12/5/00. Y Y 12/04/2000 12/04/2000 0 NONE PVT OTH NONE NONE NONE 1
0174279 08/14/2001 NC 1.0 0 .7 M 08/09/2001 Information has been received concerning an approx. 12 month old male who in 1998 was vaccinated with MMRII. In approx. 1998, "soon after" vaccination, the pt developed autism. Unspecified medical attention was sought. Upon internal review, autism was determined to be an "Other Important Medical Event". Additional information has been requested. F/U: This is an amended report. The narrative has been changed to indicate that the information was received from the pt's mother and the pt's age was changed to approx. 12 months old. Y N 01/01/1998 01/01/1998 0 OTH OTH NONE NONE NONE WAES01080278 1
0174285 08/14/2001 UT 46.0 46 F 08/09/2001 Information has been received from a MA concerning a 46 year old female with NKDA who on 7/19/01, was vaccinated with pneumococcal vaccine 23 polyvalent (lot 0945X) into the left deltoid. Concomitant therapy included ibuprofen (Motrin) and acetaminophen (-) and codeine phosphate (Tylenol with codeine #3). The MA indicated that there was no immediate site reaction noted The MA reported that on 7/21/01, the day after the vaccination, she started with fever, chills, swelling and erythema. the symptoms progressed until 07/22/2001 when she went to her local ER complaining of a sore left arm with redness that was warm to the touch. she was treated for possible cellulitis while in the Er, the patient was given intravenous(IV) cephalexin (Keflex) and released on oral cephalexin (Keflex) At a follow-up visit, the pt had recovered from the possible cellulitis. The MA indicated that the treating ER physician felt the pt's event was related to the pneumococcal vaccine 23 polyvalent vaccine. It was noted that the vaccine multidose vial was tested and it "cultured no growth. Upon internal review, possible cellulitis was determined to be an "Other Important Medical Event". Additional information has been requested. Y Y 07/19/2001 07/21/2001 2 UNK UNK Tylenol with codeine #3; Motrin UNK WAES01072514 1
0174287 08/14/2001 NY 2.0 1 .0 M 08/08/2001 Information has been received from a physician concerning a 2 year old male who on 8/6/97, was vaccinated with MMRII (lot 1537H and 0872B). The physician reported that in 1998, at age 2, the pt was seen for autism. The physician indicated that the pt was developing normally while in his care (last seen in 12/97). The physician also indicated that he is unsure which lot # of MMRII the pt received as both were documented in the pt's medical report. Upon internal review, autism was considered serious due to an "Other Important Medical Event". Additional information has been requested. U 08/06/1997 01/01/1998 148 UNK UNK UNK Lactose intolerance WAES01072607 1
0174288 08/14/2001 VA 30.0 30 M 08/08/2001 Information has been received from a health professional concerning a 30 year old Asian male with no known drug allergies who on 7/27/01 was vaccinated with MMRII (lot 637872/1517K). Concomitant therapy included varicella virus vaccine live (lot 637957/1882K) and tuberculin purified protein derivative test. It was noted that a family member reported to the health care professionals that soon after his vaccinations, he could not see at all out of his left eye. It was noted that the pt and family members spoke very little English. By 7/29/01, he was able to see again. It was reported that the PPD test was positive. Unspecified medical attention was sought. Upon internal review monocular blindness was considered an "Other Important Medical Event". Additional information has been requested. Y Y 07/27/2001 07/27/2001 0 Mantoux test on 7/27/01-(+) OTH OTH Tuberculin purified protein; Mantoux test on 7/27/01 (+) UNK WAES01080034 1
0174289 08/14/2001 VA F 08/08/2001 Information has been received from a physician concerning a female pt who on 2/7/92 was vaccinated with Hep-B vaccine recombinant (yeast). Subsequently, the pt developed neuritis. She was treated with prednisone and the symptoms took about 3 to 6 months to go away. It was reported that for the past 8 or 9 years the pt was fine, but presented in approx. 6/01 with severe pain. The pt reported that it was "the same pain she experienced when she received Hep-B recombinant (yeast) (MSD) in 1992". The pain was described as starting in the bicep and radiating down into the forearm. The pt was seen by a neurologist and was not dx'd with neuritis at that time. The doctor stated that the pain was severe on physical exam. The pt had refused treatment. Follow up info was recvd from MD who reported that on 7/23/01, pt presented to his office with severe arm pain. The MD gave the pt a very thorough exam and noted that the pt had weaker hand grasp on left, pain in the left bicep to elbow and increased pain with ROM. The pt has not been seen again and the current status is not known. The reporter felt the neuritis was related to vaccination with Hep-B vaccine recombinant (yeast). Upon internal review, the pt's experience was considered an "Other Important Medical Event". Additional information has been requested. Y Y 02/07/1992 02/28/1992 21 OTH OTH UNK UNK WAES01080011 1
0174302 08/14/2001 FL F 08/03/2001 Information has been received from a physician concerning a female who in approx. 5/96, was vaccinated with a dose of rubella virus vaccine live (second generation). Subsequently, pt found out she was 10 days pregnant at the time of vaccination. The pregnancy was uneventful other than the development of gestational diabates which was well controlled. On 2/1/97, the female gave birth to a male child. The child was born with disabilities including: mental retardation and muscular skeletal problems, specifically balance and hypotonia. F/U states that a pregnancy test was not performed prior to vaccination and that the pt received the vaccine prior to missing her menstrual period. The child was delivered by C-scetion (due to failure in progress). It was reported that the child has been seen by a neurologist; however, he has been unable to dx the child with a definite syndrome. It was also noted that the physician thought that the child would continue to require custodial care. Upon internal review, the child's experience of mental retardation was determined to be an "Other Important Medical Event". F/u info has been received and indicated that no additional info was available pertaining to this event. Y U 05/01/1996 Beta HCG 5/96-pregnant UNK UNK UNK Pregnancy (LMP-unknown) WAES01072062 1
0174306 08/14/2001 TN 10.0 10 M Left Bell's Palsy. Rx'd corticosteroids and consult neurologist. Y N 07/24/2001 07/28/2001 4 No VZV IgG antibody detected which suggests a recent or past infection; thyroid stimulating hormone; Epstein-Barr Virus-Antibody not detected PVT PVT NONE 1
0174308 08/14/2001 PA M 08/07/2001 8 year old male develops varicella encephalitis/cerebral ataxia and chickenpox which was seen after receiving chickenpox vaccine. Pt had decreased appetite, dizziness, somnolence, mild nystagmus, persistent vomiting and covered with chickenpox lesions. Treated with antiemetics, Tan and IV acyclovir with good results. Y 8 Y 04/12/2001 04/19/2001 7 OTH OTH NONE NONE History of bronchiolitis and asthma 1
0174309 08/14/2001 NJ 0.4 0 .4 M 08/08/2001 Body shook, eyes rolled back and went limp. No cyanosis. This lasted for 30 seconds. Dx'd with seizure and admitted to the hospital; afebrile at the time. Pt was pale and groggy after the event. Y 1 Y 07/31/2001 08/02/2001 2 MRI-neg PVT PVT Mylanta; Bethanechol Prematurity 29 week and 3 days secondary to maternal pre-eclampsia; Apnea on monitor; GERD 1
0174310 08/14/2001 CA 55.0 55 F 06/25/2001 Pt returned to clinic 1 month, post vax, and states that her right arm became very red and swollen at the site of injection and now has difficulty with moving arm. Y N 03/29/2001 03/29/2001 0 PUB PUB NONE DM, HTN, hyperlipidemia 1
0174311 08/14/2001 VA 0.3 0 .3 M 08/10/2001 Pt was given routine vaccines (DTAP, IPV, HIB, Prevnar) and 2-3 days later, he developed a seizure disorder and developmental delay. Doc 203598 states that patient has Infantile spasms. Y Y 12 N 07/23/2001 07/28/2001 5 Hypsarrhythmia on EEG PVT UNK Pepcid AC Acid reflux 1
0174312 08/14/2001 WV 1.08 1 .1 F 08/09/2001 7 days, post vax, MMR and Prevnar, pt had a 30 second seizure. 11 days, post vax, of MMR and Prevnar, pt had a 1 1/2 minute seizure. Pt was started on Tegretol. Also diagnosed with dehyration. Y Y 2 Y 07/27/2001 08/04/2001 8 EEG, CT, MRI PVT PVT NONE NONE NONE 1
0174313 08/14/2001 MI 0.3 0 .3 F 08/10/2001 Infantile spasms, seizures, brain damage and developmental delay. My daughter was hospitalized for diarrhea and stomach cramps on 1/23/01. We were not sure what was wrong with her so we took her to the ER. She had also been sick for a few weeks. It was discovered, after being admitted to the hospital and several test later, that she had infantile spasms. Her 2nd negative reaction occurred a few months after being dx'd with infantile spasms. We were encouraged to immunize her and within 5 minutes of receiving 4 immunizations, on 3/27/01, the seizures came back worst than ever. Her development ceased and the seizures are no where close to being under control. The 60 day follow-up states that she has seizures and she is developmentally delayed. Y Y Y 5 Y N 12/05/2000 12/21/2000 16 EEG; MRI; etc. PVT OTH NONE NONE NONE 1
0174314 08/14/2001 MI 0.6 0 .6 F 08/10/2001 Seizures became worse and all progress made with development stopped and declined. Her second negative reaction occurred a few months after being dx'd with infantile spasms. We were encouraged to immunize her and within 5 minutes of receiving 4 immunizations, on 3/27/01, the seizures came back worse than before. Her development ceased and the seizures are no where close to being under control. The 1st onset date of adverse events was 12/21/00. The 60 day follow-up states that she has more seizures and her development is further delayed. Y Y N 03/27/2001 03/27/2001 0 EEG; MRI; etc PVT OTH Vigabatrim NONE 1
0174315 08/14/2001 IL 0.3 0 .3 M 08/07/2001 Found pt crying for over 4 hours about 18 hours, post vax. Pt doing better at time mother brought baby in; bright and burning arm. Y 08/01/2001 08/01/2001 0 PVT PUB NONE 1
0174316 08/14/2001 UT 0.2 0 .2 F 2 hours of inconsolable crying; onset about 4 hours, post vax, then continued to be fussy but consolable. Y 08/06/2001 08/06/2001 0 NONE PVT PVT 1
0174317 08/14/2001 CO 1.25 1 .3 F 08/08/2001 Per mother, pt ate lunch, took longer afternoon nap, ate dinner. She had clinging. Temperature was 99F at 18:00. She fell asleep in mom's arms at 19:00. When she awoke at 19:45 she had a seizure X 30 seconds. Her eyes rolled back, turned white, foaming at the mouth, not breathing and had rhythmic shaking. Paramedics called and started IV. She was taken to ER and saw doctor and was told everything ok; no treatment. Seen by another doctor the next day and had an ear infection. Y Y 01/24/2001 01/24/2001 0 PUB PUB Tylenol 30 minutes before shots and at 16:00 NONE NONE 1
0174318 08/14/2001 RI 0.4 0 .5 M 08/02/2001 Within 2 hours, post vax, pt developed swelling of face and extremities plus erythema. He also had sharply demarcated border of erythema where short/shorts/socks began. He had increased erythema with sun exposure. No new foods or changes in environment. He is recovering. Y Y 07/31/2001 07/31/2001 0 PUB PUB 1
0174319 08/14/2001 AZ 2.0 1 1 F 08/09/2001 2 hours, post vax, pt had a fever, irritability and crying. Since, has had emesis, arm tremor, circumoral cyanosis, per mom. Seen in ER. Alert, crying and easily consoled. Force liquids. Y Y 06/07/2001 06/07/2001 0 NONE PVT PUB NONE Reddened throat per ER NONE 1
0174320 08/14/2001 SD 0.8 0 .6 M 08/03/2001 Urticarial-type rash (serum sickness like) that started 1 1/2 days after immunizations and recurred X 2. After 2/14/01 and 4/18/01 immunizations had concomitant shots on these 2 dates which were Hib and Prevnar. No respiratory symptoms. Y Y 04/18/2001 04/20/2001 2 NONE PVT PUB NONE NONE 1
0174321 08/14/2001 AZ 0.9 0 .9 M 08/07/2001 3 hours, post vax, mother reported slight local reaction and a fever. The fever lasted 5 days. Mother said the child screamed constantly and didn't sleep for 4 days except for 20 minutes at a time. Y 07/11/2001 07/11/2001 0 PVT PUB Mother complained that child was not sleeping through the night. Ear infection AZ0122 1
0174322 08/14/2001 MI 1.6 1 .6 M 08/07/2001 Pt developed a rash at home, approx. 45 minutes, post vax. Y 06/28/2001 06/28/2001 0 PVT PVT NONE NONE 1
0174323 08/14/2001 VA 46.0 46 M 07/24/2001 On 7/23/01, telephone call from client, reported a rash and was instructed to take Benadryl. On 7/24/01, telephone call to client, reports noticed scratching on Friday and "pins and needles on hand" denies fever. Rosy patches reported on torso and legs. Took Benadryl/Ultra Allergy and reports it made him very tired. Took Ultra Tab on 7/23/01. Today, reports that the rash has improved and he was encouraged to drink fluids and to avoid scratching. Suggested Benadryl ointment to apply for itching. Y 07/20/2001 07/20/2001 0 PVT PVT NONE NONE 1
0174324 08/14/2001 MO 4.0 4 M 07/26/2001 Mother called on 7/26/01 complaining of redness, swelling and a rash at the RAT area of injection from 7/24/01. The redness, rash and swelling began after giving Claritin D on 7/25/01. Area of redness and swelling size of pop lid. Y Y 07/24/2001 07/25/2001 1 PUB OTH Claritin D NONE NONE MO2001042 1
0174325 08/14/2001 AK 1.2 1 .2 F 07/15/2001 The evening of her shots, she experienced a red, raised rash on her trunk that traveled over a 1 week period of time, to extremities and back and has resolved. She had a fever of 101F X 3 days and was seen in ER. The MD stated "it's from the shots". Y Y 07/11/2001 07/12/2001 1 NONE PUB PUB NONE NONE NONE AK200149 1
0174326 08/14/2001 AK 1.0 1 .0 F 05/15/2001 Full body rash with (illness) fever and malaise about 10 days, post vax. Pt was seen in MD office with measles-like rash; no other illnesses. Resolved after "several days". Y Y 05/03/2001 05/13/2001 10 NONE PUB PUB NONE NONE NONE AK200148 1
0174327 08/14/2001 AK 50.0 49 F 07/30/2001 Pt received TD on 6/17/01 due to a laceration on left middle finger. Pt returned on 7/2/01 complaining of left arm pain that radiates down to fingers. Describes pain as sharp and throbbing. Pt had been in for further exam and evaluation. Also, complained of loss of ROM of left arm. Pt had been treating with Motrin and Valium. Pt seen on 7/30/01 with symptoms of brachial neuritis. Y N 06/17/2001 06/20/2001 3 OTH PUB Synthroid, Vivelle patch Left finger laceration AK200150 1
0174328 08/14/2001 NC 2.0 2 .3 F 07/25/2001 Site of injection of right thigh was red, swollen, warm to touch and tender to touch X 48 hours. Y 07/23/2001 07/23/2001 0 NONE PVT PUB NONE NONE NONE NC01068 1
0174329 08/14/2001 NY 4.0 4 M 08/09/2001 Swelling of the whole thigh (right) with a red patch 1 1/2" in diameter around the site of the injection; itchy. The thigh felt warmer than the other thigh. U 08/06/2001 08/07/2001 1 NONE PVT PVT UNK 1
0174330 08/14/2001 NC 55.0 55 M 08/10/2001 Reason for TD was a dog bite on 8/5/01 at 20:00. On 8/6/01 PM, "head felt funny". On 8/7/01, "ached all over". On 8/8/01, left arm got hot and red around injection site. On 8/9/01, redness and swelling increased and went to ER and was treated for cellulitis. Y Y 08/06/2001 08/06/2001 0 PUB UNK Ziac, Lipitor NONE High BP; high cholesterol; allergy to Aleve 1
0174331 08/14/2001 OK 1.2 1 .1 M 08/06/2001 Thigh is red, swollen and warm to the tough. Y Y 08/01/2001 08/02/2001 1 PVT PUB NONE NONE NONE 1
0174332 08/14/2001 OK 2.0 2 .0 M Pt had redness to injection site with increased warmth and swelling. Y Y 08/01/2001 08/03/2001 2 PVT PUB 1
0174333 08/14/2001 AK 42.0 42 M 08/06/2001 Seen in ER for swollen and painful throat and uvula. Thought it was due to spraying deck. Given Z-pack, Prednisone and Benadryl. Upon arrival for Hep B #2 shot, reported to us of ER visit and could this be from shots. Looked up adverse reactions and yes it could be. No further shots to be given. Y Y 06/07/2001 06/09/2001 2 PVT PVT NONE 1
0174334 08/14/2001 WI 72.0 72 M 08/03/2001 Arm vaccinated was very sore and non-movable. Pt had a fever and was nauseated X 24 hours. Y 07/26/2001 07/26/2001 0 OTH OTH 1
0174335 08/14/2001 IL 1.5 1 .5 M 08/06/2001 Pt had a febrile seizure on 8/5/01 and was treated at the hospital with Tylenol suppository. Detected otitis media and treated with amoxicillin. Temperature was 103.5F. Seizure lasted 3-4 minutes. Y Y 07/27/2001 08/06/2001 10 NONE PVT UNK NONE NONE 1
0174336 08/14/2001 SC 1.5 1 .5 F 08/02/2001 24 hours, post vax, pt had firm and red area noted. 48 hours, post vax, pt had swollen, red upper thigh with nodule noted. Y 07/31/2001 08/01/2001 1 NONE PVT PVT NONE NONE 1
0174337 08/14/2001 SC 4.0 4 M 08/01/2001 Swelling and erythema of right thigh beginning 24 hours, post vax. Y 07/30/2001 07/31/2001 1 NONE PVT PVT 1
0174338 08/14/2001 CA 28.0 28 F 08/01/2001 Very tired, fever and chills, cream colored stools X 2 days, post vax. Loss of appetite and headaches everyday since injection. Has private insurance. Referred to PMD. Appt scheduled for 8/2/01 at 09:00. N 07/12/2001 07/12/2001 0 PUB PUB NONE NONE States today has allergy to Motrin. 1
0174339 08/14/2001 GA 1.9 1 .9 M Pt had redness and swelling of the left thigh. U 08/06/2001 08/07/2001 1 NONE PVT PUB NONE NONE NONE 1
0174340 08/14/2001 IL 41.0 40 M 07/08/2001 Pt began to feel light-headed approx. 1 hour, post vax, with tachycardia and diaphoresis. EMS was called and tool pt to ER. Treated with Vicodin and Tagamet. No Benadryl given. Y Y 05/05/2001 05/05/2001 0 NONE UNK UNK NONE NONE NONE 1
0174341 08/14/2001 LA 34.0 34 F 08/06/2001 Pt had red welts, warm to touch in deltoid area. Treated with Keflex, 500mg and Vistaril 25mg. Y 08/01/2001 08/03/2001 2 PVT PVT 8/1/01-PPD/Aventis/C0832AA/LFA/0 previously NONE Allergy to PCN 1
0174342 08/14/2001 CT 3.0 1 .0 F 08/07/2001 Pt developed a rash on her left arm and hand. Dx'd with shingles. Y U 07/01/1999 08/04/2001 765 Visual exam in office PVT OTH NONE NONE 1
0174343 08/14/2001 ID 2.0 2 .1 F 08/06/2001 Mom called at 18:00 on 8/1/01 to report that her child had had hives on face for approx. 2 hours. Y 08/01/2001 08/01/2001 0 PVT PUB NONE 1
0174344 08/14/2001 GA 1.0 1 .1 F 08/13/2000 Mother reports, starting on 8/10/01, pt had rash looking like bug bites with blisters (5-10 lesions total), low-grade fevers of 100F-100.5F. Exam reveals erythematous, macular rash with central papular lesion on trunk X 3-4, on face X 2, in hair X 1, on arm X1 and on leg X 1. Y 07/31/2001 08/10/2001 10 NONE PVT PUB NONE Peripheral Pulmonic Stenosis 1
0174345 08/14/2001 IA 1.25 1 .3 M 08/05/2001 Phone call on 8/3/01 from mother to report increased fever. Woke up at 01:30 today with a fever of 106F (R). Called ER and was advised to give Motrin. She did and the fever went down within 20 minutes. Pt slept the rest of the night and at 07:30 on 8/3/01 pt had a fever of 101F (R). He was given Motrin again. No other symptoms. He did have Tylenol 1/2 hour prior to vaccines and at 13:30 the day of vaccines as he was fussy and crying. As of 8/3/01 phone call, temperature is "still up slightly". N 08/02/2001 08/03/2001 1 PUB PUB NONE NONE IA01011 1
0174346 08/14/2001 CA 23.0 23 F 08/10/2001 After 45 minutes of administering Hep-B vaccine, pt experienced redness and itching at right arm, with generalized itching followed after 5 more minutes. Y Y 08/10/2001 08/10/2001 0 OTH PVT Deconamine SR, Nasacort, Celexa, Micronor, Prilosec, Fioricet prn NONE 1
0174347 08/14/2001 IL 7.0 1 .5 M 06/04/2001 Parent and tot in class in 1995-1996, noticed he was behind in speech and had an unsteady gait by the end of class. Tested in 1997 by private doctor and results PDD NOS. N 11/27/1995 11/27/1995 0 PVT OTH NONE NONE 1
0174350 08/15/2001 MI 0.5 0 .6 F 08/07/2001 On 10/14/1993 at 8 months of age, the infant became ill and had an elevated WBC. She developed viral infections and ear infections on a regular basis (approximately once a month), beginning at 8 months of age. The infant's language development stopped at 16 months of age, and she had recurrent tonsillitis up to the age of 2.5 years. On 8/28/1995 at the age of 2.5 years, the child had a tonsillectomy. The mother reported the child was not engaging in imaginative play at the age of two years old. The child was examined by a psychologist and was assessed for language skills. On an unknown date, she was diagnosed with autism. Y Y N 09/02/1993 urinalysis - positive for heavy metals, including mercury, arsenic and lead, EEG - neg for epilepsy, MRI - neg PUB PUB NONE NONE NONE 01TR0014 1
0174351 08/15/2001 ID M 07/17/2001 Starting with 1st shot, noticed the increased psychological effects stated in the medical records. Not recovered. Y N 09/27/1999 09/27/1999 0 NONE MIL MIL NONE NONE NONE 1
0174352 08/15/2001 UT 0.2 0 .2 F 08/07/2001 Pt's fever was 103.8F for 3 days. Y Y 07/27/2001 WBC-low; Segmented Neutrophils 4-low; lymphocytes 84-high; Neutrophils Abs count 0.5-low; monocytes, Abs count 0.1-low PVT PVT NONE NONE 1
0174353 08/15/2001 WI 5.0 5 M 08/02/2001 Received vaccines on 7/25/01 at 16:15. Tylenol was given prior to shots at 15:15. At about 18:45 pt became tired, arms hurt and legs were tired. He felt warm. Tylenol was given at bedtime. On 7/26/01, he went to Daycare and his only complaint was sore arms. At the end of the day (15:30) he was congested and with cold symptoms. Tylenol given at bedtime. On 7/27/01, later in the day, he developed a dry cough. On 7/28/01, he slept on and off throughout the day with a bad productive cough. In the middle of the night, acted differently. Sleeping and complaining of having a hard time breathing. He was taken to ER. No fever. Oxygen at 88%. He will be followed-up with pulmonary functional test. He was given Bioxin, Prednisone, Nebulizer and O2 in the hospital and discharged on 7/30/01 with O2 sats at 93% and lungs sounded better. Per doc 204160, 60 day follow up, patient has subsequently been diagnosed with Athsma. Y Y 2 Y 07/25/2001 07/25/2001 0 Chest X-ray; blood work-WBC-ok; PUB PUB Tylenol NONE Heart murmur (no activity restrictions) 1
0174354 08/15/2001 NY 65.0 65 M 08/07/2001 Pt had an arthritis attack. His thumb has had visits to hand surgeon and injection of cortisone. He has pains in his neck and knee. Visited rheumatologist and given medications. Y N 02/01/2001 02/01/2001 0 PVT PUB Avapro; Lipitor; Celebrex Osteoporosis, HTN, Hyperlipidemia 1
0174355 08/15/2001 WI 8.0 M 08/10/2001 On 8/7/01, the pt complained of pain, redness in right upper leg after sliding on mat on large slide at the fair. Pt had 12" X 7" of redness on right upper leg and a blotchy rash on both legs. Afebrile. Admitted to hospital on 8/7/00 with apparent cellulitis at right upper leg. Discharge on 8/8/01. Y 1 Y 08/06/2001 08/07/2001 1 Blood culture-neg; CBC-WNL; Sed Rate-WNL; Spinal report-pending PVT PVT NONE Asthma 1
0174356 08/15/2001 IN 1.08 1 .1 M 08/07/2001 Child in office on 8/4/01 for 12 month exam. Received Varivax and MMR, SC, both given in left leg. Almost immediately, left leg became swollen about 5cm X 5cm and erythematous. After Benadryl was give, erythema lessened and edema did not increase. No respiratory symptoms, no respiratory distress and no hives. Left office about 10:30 in good spirits and no further symptoms. Inflammation decreased by 8/4/01 PM. Slight bruise only at site as of 8/7/01 PM. Y 08/04/2001 08/04/2001 0 PVT PUB 1
0174357 08/15/2001 CA 0.25 0 .3 M Anaphylaxis with generalized confluent urticaria and painful crying. Y Y 08/01/2001 08/01/2001 0 PVT PVT NONE 1
0174358 08/15/2001 AZ 0.3 0 .3 F 08/07/2001 Pt had inconsolable crying for 3-4 hours, post vax. Y 08/06/2001 08/06/2001 0 NONE PVT PVT Mild enteritis NONE 1
0174359 08/15/2001 NJ 0.5 0 .5 F 08/09/2001 2.5" local redness, LLE, +1 tenderness, between injection sites. Y 08/07/2001 08/07/2001 0 NONE PVT UNK NONE NONE 1
0174360 08/15/2001 VT 3.0 3 F 08/08/2001 Fever starting 1 day, post vax of PCV. Y Y 07/27/2001 07/28/2001 1 UA-neg PVT UNK NONE NONE NONE 1
0174361 08/15/2001 KS 0.3 0 .3 M 08/06/2001 Did not have antipyretic prior to immunizations. Got Tylenol 30 minutes to 1 hours, post vax. pt had inconsolable crying that began 3 hours, post vax, and lasting 3 hours. Physician did not return mother's call. Leg not swollen or hard. Y 07/27/2001 07/27/2001 0 NONE PUB PUB History of pneumonia 1
0174362 08/15/2001 NJ 1.08 1 .0 M 08/08/2001 Received call from mother stating child had easy bruising and petechia on 7/29/01 and was sent for blood work and platelet count was 55,000. Y 07/06/2001 07/29/2001 23 Platelet count on 7/31/01-55,000; repeated on 8/6/01 and was 138,000 PVT PVT Thalassemia minor; prematurity 1
0174363 08/15/2001 NC 1.5 1 .5 M 08/06/2001 Pt had a local reaction on right thigh with 10cm induration and erythema. Pt stable. Y 08/06/2001 08/06/2001 0 MIL MIL Tylenol NONE NONE 1
0174364 08/15/2001 KS 1.25 1 .2 F 08/09/2001 Pt had a swollen left eye, rash and a fever of 102F. Y Y 07/09/2001 07/14/2001 5 PUB PUB NONE NONE Reaction to Amoxil 1
0174365 08/15/2001 AZ 1.25 1 .3 F 07/19/2001 Pt developed bilateral thigh cellulitis, right more than left. Temperature of 100.6F. The right thigh was 7cm X 3cm and left thigh was 2 1/2cm X 1 1/2cm area under cellulitis with firmness, not fluctuant. No TTP. Y Y 07/16/2001 07/16/2001 0 PUB PUB NONE NONE 1
0174366 08/15/2001 CT 39.0 37 F 07/16/2001 Pt developed joint pain, burning aches, heart palpitations, light-headedness, mild stiff neck and chills which started the night after 1st shot and continued. Comes on, in early spring 2000 and 2001 and continued throughout the summer. Had 2 more shots of Lymerix since the 1st one. U 03/12/1999 03/20/1999 8 Blood work PVT OTH Flonase; Allegra NONE NONE 1
0174367 08/15/2001 NY 1.4 1 .4 F 08/03/2001 Seven days, post vax, pt had a febrile seizure. Went to ER after seizure work-up began; MD in ER dx'd otitis media. Rx Motrin and 2 days after ER visit, no better. Y N 07/25/2001 08/01/2001 7 PVT PVT NONE NONE 1
0174368 08/15/2001 WV 5.0 4 M 08/09/2001 2 3/4" large, red, raised area, warm to the touch. Mother gave Tylenol. This was on the left thigh. Y 07/30/2001 08/01/2001 2 NONE PVT OTH NONE NONE Enuresis 1
0174369 08/15/2001 MN 12.0 12 M 08/08/2001 Pt developed white raised area around the site of injection. It doesn't hurt but is just apparent and was still present when 2nd dose was given on 6/16/01. N 05/16/2001 05/16/2001 0 OTH OTH Albuterol inhaler; Vancenase nose spray NONE Asthma 1
0174370 08/15/2001 OK 5.0 5 F 08/09/2001 Call to clinic with raised confluent rash on right deltoid, covering about 3/4 exterior surface. Y 08/02/2001 08/03/2001 1 PUB PUB NONE NONE NONE 1
0174371 08/15/2001 NJ 0.25 0 .2 F 08/08/2001 Screaming pt up to 36 hrs uncontrollably, on and off. Pt vomited several times in a 24 hour period and some diarrhea. U 08/02/2001 08/02/2001 0 PVT PVT NONE NONE 1
0174372 08/15/2001 FL 4.0 4 M 08/10/2001 Respiratory difficulty, facial swelling, wheezing. Pulse oximetry 92 prior to treatment. Treated with Xopenex 0.63mg; Benadryl 0.5 ml (IM); Epinephrine 0.2 ml (SC) and Oraprid 15/5 X 3 days. Y Y 08/02/2001 08/02/2001 0 PVT PVT NONE NONE Eczema; Asthmatic Bronchitis; Viral Meningitis 1
0174373 08/15/2001 IN 4.0 4 M 08/07/2001 Y Y 08/03/2001 08/03/2001 0 PVT PUB Dallergy Allergic Rhinitis Asthma; Seasonal allergies 1
0174374 08/15/2001 WA 7.0 7 M 08/05/2001 Pt here with social worker for shots. Pt left clinic and returned with social worker in about 1 hour later with complaint of itching, swelling at eye and face. Social worker reports voice became raspy. Pt assessed by PA and given Benadryl (IM). Symptoms then resolved. Rx'd Benadryl X 24 hours. Y 08/01/2001 08/01/2001 0 PUB PUB NONE NONE History of ROM; allergic rhinitis 1
0174375 08/15/2001 WV 1.8 1 .9 M 08/08/2001 Started on 8/4/01 with grouped lesions on back. Y 06/30/1998 08/04/2001 1131 PVT PVT 1
0174376 08/15/2001 NJ 0.3 0 .3 F 08/08/2001 Pt was screaming uncontrollably for several hours. Treated with Tylenol and it helped slightly. Y 08/01/2001 08/01/2001 0 PVT PVT NONE 1
0174377 08/15/2001 NJ 0.7 0 .7 F 08/08/2001 Pt was very tired, not herself and difficult to awaken for 6 hours. Y 08/01/2001 08/01/2001 0 PVT PVT NONE 1
0174378 08/15/2001 RI 1.5 1 .7 M 08/07/2001 Onset within 15 minutes with generalized erythema with wheals, involving about 50% of surface area. No respiratory distress. Y Y 08/07/2001 08/07/2001 0 NONE PUB PUB NONE NONE 1
0174379 08/15/2001 MO 45.0 45 F 08/07/2001 Pt had a localized reaction at the injection site of left deltoid and then generalized hives over the rest of her body including her chin. No respiratory involvement. The employee was given IV Solu-Medrol 125mg in the clinic at 15:55 and sent home at 17:00 with a Medrol dose Pak and Benadryl 25mg po for HS usage. Currently, she is being worked-up by allergy clinic. Y Y 06/27/2001 06/27/2001 0 Labs drawn the next day showed an elevated WBC count 25.8 and glucose of 151. On 7/20/01 her glucose was 162 and WBC was 10.8. OTH OTH NONE NONE Reports a prior reaction to flu vaccine, but able to take TD without problems. Unspecifed reaction~Influenza (Seasonal) (no brand name)~~0.00~In Patient 1
0174380 08/15/2001 OK 8.0 8 F 08/08/2001 3 days, post vax, child broke out in chickenpox and ER doctor dx'd chickenpox. Y Y 08/03/2001 08/06/2001 3 PUB PUB NONE NONE 1
0174381 08/15/2001 AR 7.0 7 M 07/27/2001 Mother reports that 2 days, post vax, child began having hallucinations which lasted for about 1 month. He seen and heard things and would cry and run. He was afraid all the time. Seen MD, who felt it could be immunizations. Y Y 08/06/1999 08/08/1999 2 PUB PUB NONE NONE NONE AR0131 1
0174382 08/15/2001 KY 4.0 4 F 08/09/2001 Pt broke out with chickenpox after receiving chickenpox vaccine. Prescribed Benadryl. Y Y 07/26/2001 08/07/2001 12 PVT PUB NONE NONE 1
0174383 08/15/2001 KY 10.0 10 M 08/08/2001 Mom came into health dept on 8/2/01 to describe a possible reaction. Child was not with her. She says he has Weisenberger's Syndrome ( a muscle tone disorder) but Thursday, post vax, 2 days later, had lower leg stiffness. Friday, legs twitched a few seconds and quit at different times during the night. On Monday, this happened 1 time that night. Mom was on her way to discuss with family doctor and recommendations for other Hep-B doses. Spoke with mother on the phone about incident on 8/7/01 and she said she would research and call back. Y 07/31/2001 08/02/2001 2 PUB UNK NONE Wesinberger's Syndrome KY2001055 1
0174384 08/15/2001 CA 1.0 1 .0 F 08/13/2001 Pt had apparent breath holding spell followed by seizure activity X 1 minute with rolling back of eyes and jerking of upper and lower extremities. Y 08/10/2001 EEG-pending PVT PVT NONE NONE NONE 1
0174386 08/16/2001 CA 1.25 1 .3 M 08/15/2001 Following vax, the pt developed pneumococcal bacteremia osteomyelitis. This event is considered "medically important". Additional info recvd 8/12/01 indicated blood culture, bone scan and x-ray of the distal femur were performed. The pt was being treated with an unspecified IV antibiotic. The reporter suspected an "underlying immunocompromise." F/U information states that the pt had a medical history of recurrent ear infections and a spontaneously draining ear. The pt developed pneumococcal osteomyelitis following receipt of the 4th dose of Prevnar. Blood culture was positive; the bone scan was negative "on day 4". The X-ray of the pt's distal femur "on day 12" was positive. The pt was being treated with an unspecified IV antibiotic. F/U info received on 9/27/01, indicated that the pt received his 4th doses of Prevnar and TriHibit, as well as his 3rd dose of Engerix-B on 7/26/01. The pt had a medical history of multiple infections including recurrent otitis media (PE tubes inserted), cellulitis of his fingers and a neck infection. Two weeks prior to admission, he developed a cough and runny nose. On 7/22/01, the pt's mother noticed that her son was tip-toeing on his right foot. He then refused to walk and mostly crawled. He was irritable and had developed an intermittent low-grade fever which ranged to 100.1F. The pt was seen by the pediatrician; X-rays of his extremities were performed and were normal. On 7/25/01, he was seen again by his pediatrician and was noted to bear more weight on his right leg. His activity level had increased. On 7/27/01, the pt's activity level had decreased and he was admitted to the hospital on 7/28/01. He was seen by an infectious disease physician on 7/29/01. Physical exam revealed "positive" PE tubes. His extremities were difficult to examine because the pt cried when moved. He refused to walk. When he attempted to ambulate, his right leg was externally rotated. Ultrasounds of his hip and knee were performed and were negative. While hospitalized, the pt experienced 1 episode of fever. The pt was treated with IV vancomycin. The sensitivity of the Streptococcus pneumonia showed that the organism was highly resistent to penicillin; the pt was considered for and treated with linezolid. Prior to discharge from the hospital, an X-ray of his femur was performed; results were not available at the time of discharge (date of discharge not specified). On 8/4/01, the pt's mother contacted the infectious disease physician and reported that her son was less active (he wanted to crawl instead of walk) and he was fussy. The physician obtained the X-ray results. The X-ray revealed a small focus of destruction in the right distal femur, consistent with early osteomyelitis. He was re-admitted to the hospital on 8/5/01 and the linezolid was discontinued. On hospital admission, the pt was afebrile. On physician exam, there was full range of motion at his hips and knee joints. No focal area of tenderness was noted; however, tenderness or warmth was noted a the medial aspect of his distal femur. The pt was treated with vancomycin and ceftriaxone. Since the pt's CXR, CSF culture and bone scan were negative, the physician indicated that the pt had an unspecified source of bacteremia. Two serum samples were to be tested for antibodies on 8/2/01 and 8/27/01. Results were not provided. The physician's assessment was probable osteomyelitis of the right distal femur, probably due to Streptococcus pneumonia. The physician also indicated the need to rule out immune deficiency. Y Y U 07/16/2001 Blood culture X 2-(+) Streptococcus pneumonia; bone scan-neg; CSF-neg; CXR-neg; X-ray distal femur-(+); Ultrasounds of his hip and knee-neg; CBC-WBC-32,000 (H) with neutrophil-36% and a "lymphocytic predominance" of 56%; hemoglobin-32.8 (H); platelets 609,000 (H); ESR-44 (H); CRP-0.6; repeat CBC, ESR and CRP, quantitative immunoglobulins including IgE, HIV test and nitroblus tetrazolium reduction test; 2nd adm-WBC-246; neutrophil-30%; lymphocyte-62%; CRP-0.3; IgG-1 was 275,000, 2 was 66,000, 3 was 86,000, 4 was 12. OTH OTH UNK UNK Recurring ear infections; spontaneously draining ear; otitis media NOS; cellulitis; cough; Grommet insertion; rhinitis HQ4354908AUG2001 1
0174387 08/16/2001 TX 0.2 0 .2 M 08/15/2001 Generalized seizure with apnea occurred twice on 7/10/01, post vax, on 6/13/01. Pt was hospitalized and found to have an abnormal EEG. Pt was started on phenobarbital. Per doc 204195, 60 day follow up,patient now has seizure disorder being maintained on phenobarbit, unknown whether seizures are truly a consequence of vaccines or just a coincidental development. The annual follow-up states "pt has been on phenobarbital for a seizure disorder since the event with no seizures since 7/30/01. he is snot slowly being weaned off phenobarbital." Y Y Y 3 N 06/13/2001 07/10/2001 27 EEG-abn; CT, MRI and CSF-all normal PVT PVT NONE NONE Laryngomalacia; probable allergic rhinitis; Benadryl recommended at the same visit. 1
0174388 08/16/2001 WA 1.25 1 .3 F 08/03/2001 Pt developed a high fever ranging from 100F to 103F; fussy and tired and lacking in appetite. Y Y 06/20/2001 06/22/2001 2 PVT PVT Oral fluoride; vitamins Cold a week before vaccinations. 1
0174389 08/16/2001 TN 1.0 0 1 F 07/26/2001 On 7/24/01, pt developed a fever of 104.1F. Had a fever between 102.9F and 104F for 2 days. Also had scattered papular rash on trunk on 7/26/01. U 07/16/2001 07/24/2001 8 UA and CBC-both WNL PVT PUB Fluoride drops NONE NONE NC01071 1
0174390 08/16/2001 NC 0.75 0 .8 F 06/12/2001 Seizures Y Y 04/03/2001 04/03/2001 0 Depakote level 35.7 PUB PUB NONE Seizure disorder NC1069 1
0174391 08/16/2001 MN 0.4 0 .4 M 08/03/2001 Pt developed a temperature of 103.7F on the eve after injection. Fever down to 100.1F at 14:00 the next day. Y 08/02/2001 08/02/2001 0 PVT UNK NONE 1
0174392 08/16/2001 WA 1.25 1 .2 M 08/07/2001 Onset of fever on 6/27/01 in the AM. Dx'd as viral syndrome vs possible reaction to MMR. No treatment except fluids and Tylenol. Did not return to clinic until 7/5/01 with resolution of previous symptoms. Y 06/19/2001 06/27/2001 8 CBC-nml PVT PUB NONE NONE Allergy to Augmentin 1
0174393 08/16/2001 NM 0.3 0 .4 F 08/14/2001 I gave this child a DTAP #2, IPV #2, Hib #2 and pneumococcal #2 and within seconds the child's legs were red and it was moving downwards with swelling. Treated him with Benadryl (IM) 0.2 ml. Y 08/14/2001 08/14/2001 0 PVT OTH 1
0174394 08/16/2001 PA 0.3 0 .3 F 08/09/2001 Pt had cold symptoms with elevated temperature of 1 hour, starting on 4/11/01. Cold symptoms continued until 5/22/01 but temperature ended on 4/11/01. Used acetaminophen for elevated temperature from 4/11/01 to 4/11/01. Used ? for cold symptoms from 5/15/01 to 6/10/01. Y 04/10/2001 04/11/2001 1 PVT OTH Phenergan NONE NONE Congestion~Pneumo (Prevnar)~1~0.00~In Patient 1
0174395 08/16/2001 NY 51.0 48 M 08/10/2001 My body aches all over and my arm is full of arthritis. Sometimes, I can't get out of bed in the morning. I live with constant pain, ever since I took this Lyme vaccine. I had Lymerix on 6/14/99 and 3/13/00, also. I am presently being treated by a Rheumatologist for these symptoms. I was Rx'd with Celebrex 100mg X 60. I am now into a class action law suit concerning Lymerix vaccinations. N 05/17/1999 ELISA and Western Blot-both neg for Lyme PVT UNK NONE NONE 1
0174396 08/16/2001 CA 0.5 0 .5 M 08/04/2001 Two days post vaccination, pt developed 7 X4 1/2 cm red, raised, warm lesion. U 08/07/2001 08/09/2001 2 PVT PVT NONE NONE NONE 1
0174397 08/16/2001 GA 56.0 56 F 08/10/2001 Fever of 102.5F, 2 days, gradually decreased over the next 3-4 days; measles all over for about a week from measles shot required for Nursing School. Y 05/15/2001 05/17/2001 2 UNK UNK TB and Syphilis on 5/15/01 NONE NONE 1
0174398 08/16/2001 WA 1.08 1 .1 F 08/06/2001 Pt developed a fever up to 103.5F reported at home on 8/1/01. She had erythematous papular lesions appear 1st on trunk and then on face on 8/3/01. She was seen that day at ER. She was dx'd with viral exanthem. Seen today, 8/6/01, afebrile. Rash continues. Y N 07/24/2001 08/01/2001 8 PUB PUB NONE NONE 1
0174399 08/16/2001 FL M Pt developed bumps (crusted) that started spreading on left abdomen and chin area. U 04/01/1996 08/06/2001 1953 PVT PVT NONE NONE NONE 1
0174400 08/16/2001 OR 65.0 65 F 08/09/2001 Pt had headache, arthralgia, anorexia, nausea, pharyngitis, malaise, lasting approximately 24 hours. Y 06/11/2001 06/13/2001 2 NONE OTH PUB NONE NONE NONE 1
0174401 08/16/2001 CA 1.25 1 .3 F 08/03/2001 Pt received vaccination on 7/17/01 and on 7/23 developed fever to 101.5 with strange behavior. She was babbling, moving hands around, and seemed to fall down more than usual. Parents concerned. On 7/28 fever was to 103, and cranky. Pt was somewhat better the next 2 days. Seen in office 7/27. Pt had normal active behavior, tms dull, otherwise all WNL. Y Y 07/17/2001 07/23/2001 6 PVT PVT NONE G6PD deficiency-mild 1
0174402 08/16/2001 FL 1.0 1 .0 F 08/09/2001 pt developed a fever up to 103.9 on day 8 after vaccination. She also developed a macular papular rash over entire body with associated mild conjunctivitis. Y Y 07/30/2001 08/08/2001 9 NONE PVT PUB NONE NONE 1
0174403 08/16/2001 NY 5.0 5 M 08/06/2001 Mother reports reddened bruise like area around injection site at top of left arm. It extends downward approximately 1 inch. Sensitive to light touch but no pain with heavier touch. Follow up on 03/18/04: "Mother reports reddened bruise like area around injection site at top of left arm. Area extends downward approximately 1 inch. Sensitive to light touch but no pain with heavier touch. No changes in appetite, sleep or breathing." Y 08/02/2001 08/08/2001 6 PUB PUB NONE NONE NYS23001 1
0174404 08/16/2001 NC 4.0 4 F 08/05/2001 Pt has seizure after each of three MMR, 7/97,7/01,8/01. Y Y 06/25/2001 07/09/2001 14 Head CT was normal; Labs were normal PVT PUB NONE Allergy to codeine seizure~Measles + Mumps + Rubella (MMR II)~1~1.00~In Patient NC01070 1
0174405 08/16/2001 MO 1.5 1 .4 F 08/07/2001 On 8/2/01 pt developed a fever, was irritable, congested, cried all the time. On 8/6/01 she developed hives. Y U 07/23/2001 08/02/2001 10 Strep test done-negative PUB PUB NONE NONE NONE 1
0174406 08/16/2001 MT 5.0 5 M 08/10/2001 Pt received vaccines this morning, approx 1000 this am, home about 1045, pt went outside to play, at 1105 dad noticed pt looked red, 1115 dad saw some bumps on skin, called immun. clinic, instructed to call peds, instructed to come in upon arrival pt flushed? face to waist with large hives on trunk. Face, scattered hives on legs given Benadry 12.5mg/5mg tsp; no resp effort; pulse ox 99%, T 99, pulse 92, resp 24. Monitored x 2 hrs-released home. Y 08/10/2001 08/10/2001 0 12.5mg/5mg tsp; no resp effort; pulse ox 99%, T 99, pulse 92, resp 24. MIL MIL NONE NONE 1
0174407 08/16/2001 NC 5.0 5 M 08/07/2001 Pt developed Henoch-Schonlein-Purpura. Y U 07/23/2001 07/25/2001 2 NONE PVT PUB RAD 1
0174408 08/16/2001 TX 4.0 4 F 08/07/2001 Pt experienced swelling and decrease in respiratory functions and decrease in cardiovascular functions. Dr ordered steroids and antihistamines and follow-up at ER. Y Y 08/02/2001 08/02/2001 0 PVT PUB NONE NONE NONE SA0110 1
0174409 08/16/2001 MI 4.0 4 F 08/10/2001 Pt developed cellulitis at site of injection per ER, Tender, red, and swelling 24 hours after vaccinations. Temperature of 101 F at home per Mom, but afebrile in ER. Treated with Keflex. Cellulitis developed at the MMR site. Y Y 08/03/2001 08/04/2001 1 PVT PVT 1
0174410 08/16/2001 MA 28.0 27 M 08/02/2001 Pt noticed left gland in neck was swelling, developed headache, which she treated with Tylenol and ibuprophen. The pt's symptoms began on Thursday 7/26/01. U 07/05/2001 07/26/2001 21 OTH UNK NONE NONE NONE 1
0174411 08/16/2001 NV 39.0 39 F 07/17/2001 Severe pain in left jaw-the same side the shot was given. I felt like I had a toothache. This is no longer a problem although I still have a lump in my mouth. I have diarrhea off and on, that's still a problem. I still have abdominal pains, but not as much. the muscle weakness is no longer a problem N 05/22/2001 05/23/2001 1 MIL OTH Birth control pills Toothache NONE 1
0174413 08/17/2001 MD 19.0 19 F 08/09/2001 Pt had fever of 102 F, chills, Headache onset shortly after vaccine administration. Headache progressively worsened. Admitted to hospital next day. Diagnosis was reaction to rabies vaccine. Y 1 Y 08/03/2001 08/03/2001 0 Screened for EEE PVT PUB UNK NONE NONE 1
0174414 08/17/2001 IA 1.6 1 .5 F 08/13/2001 On 8/4/01, parents noticed red spots on pt's buttocks and genital area. Assuming it was diaper rash, parents treated this with triple antibiotic ointment. On 8/5/01, the pt's rash spread to face, belly and eyes. Pt has a low-grade fever and itching. On 8/6/01, pt's fever increased to 101F-103F; given Motrin and Tylenol, alternating. Pt brought to ER/hospital per dermatologist referral. Upon admission, exam revealed multiple dry, crusted erythematous papules, right axillary lymphadenopathy, ill appearing, toxic, right eye swollen shut. Pt started on acyclovir, oxacillin, Atarax and Tylenol. Pt had staph aureus sepsis, confirmed with blood culture. Y Y 07/09/2001 08/04/2001 26 On 8/6/01 blood culture X 1 grew Staph Aureus beta lactamase positive-resistant to penicillin, but otherwise pan sensitive PVT PVT Westcort, atarax, oral steroids, Protopic, Derma Smooth Eczema History of eczema since 2-3 weeks old; treated with topical steroid Westcort + prn Atarax + prn oral steroids. Began using Protopic topical tacrolimus QD-BID approx. 3-4 months ago. 1
0174415 08/17/2001 TX 25.0 24 M 08/16/2001 Meningeal symptoms beginning on 7/20/01.Pt also had a headache, nausea, dizziness and severe malaise. Y Y 2 Y 06/29/2001 07/20/2001 21 Lumbar Puncture-nml on 8/2/01 PVT PVT On 6/29/01 was given HRIG/BayRAB/6182W01A/R Gluteal/0 previously NONE NONE 1
0174416 08/17/2001 WA 0.75 0 .7 M 08/09/2001 Mom states 4 hours after shot pt got lethargic, then about 8 hrs after shot temperature was 103.8 and started vomiting. Went to ER that evening. Fever, crankiness, shaking, heart racing. Fever lasted 3 days. Was seen in office 2 days after vaccine also, vomiting lasted 3 days. Fever went to 103 max. Y Y 07/25/2001 07/25/2001 0 NONE PVT PUB NONE NONE Severe colic as infant, reflux, soy intolerant 1
0174417 08/17/2001 AR 0.3 0 .3 M 08/08/2001 Reddened area 2 cm right thigh and area of induration about 3.5 cm at site of immunizations. Y 08/06/2001 08/07/2001 1 PVT PVT NONE 1
0174418 08/17/2001 MS 1.25 1 .3 M 07/26/2001 Developed rash on face and neck within 1-2 min after receiving immunizations. Also developed redness at injection site. Observed pt X 25 minutes. Soon pt was down playing in waiting area-rash and redness fading away when allowed to leave the health dept. Y 07/20/2001 07/20/2001 0 PUB PUB Augmentin NONE MS01034 1
0174420 08/17/2001 MA 2.0 2 .3 F 07/27/2001 after 2 weeks of receiving the chicken pox vaccine, the pt developed a mild case of the chickenpox. Y 06/06/2001 06/28/2001 22 PVT OTH NONE NONE 1
0174421 08/17/2001 NY 0.2 0 .1 F 08/13/2001 Pt had 2 episodes of right sided arm and leg jerky, rhythmic movement for 15-30 seconds and became sleepy afterwards. These occurred 12 hours after shots. Y Y 07/30/2001 07/31/2001 1 EEG abnormal slowing on right side/MRI was WNL PVT PVT NONE NONE NONE 1
0174422 08/17/2001 FL 4.0 4 F 08/10/2001 Pt developed swelling on left arm with redness and pruritus. Treated with warm compress and follow-up. Y 08/08/2001 08/08/2001 0 PVT UNK 1
0174423 08/17/2001 CA 0.6 0 .6 M 08/02/2001 Immediately, post vax, on the way home, mother noticed a high fever. She gave him a tepid bath which did not help so she took him to ER. 15 days later, the child developed seizures and was unable to move leg. On 1/98, the pt was referred to CCS and dx'd with Cerebral Palsy. This was not reported to PH until screened for immunizations on 7/25/01. The 7/7/97 was only PH visit. Child was treated and received further immunizations from other facility. Y U 07/07/1997 07/07/1997 0 PUB PUB UNK CA970120 1
0174424 08/17/2001 LA 35.0 35 F 08/09/2001 Pt reports symptoms occurred on 8/4/01 with some severe swelling, itching and hot to touch site. Pt was instructed to see MD. She reported "yes" she will. Y Y 08/01/2001 08/04/2001 3 PUB PUB NONE NONE NONE LA010801 1
0174425 08/17/2001 MT 38.0 38 F 07/10/2001 Pt had loss of consciousness with 2-3 minutes, post vax. She vomited and became incontinent of urine. She was mildly hypotensive (88/60) and bradycardic (52-64) over the next 2 hours. Treated with O2 for the first 15 minutes, then monitored until BP was stable at 110/62 and pulse was over 60 and RR were 14-18. Recovered spontaneously with no further problems after 3 hours. Y Y 07/09/2001 07/09/2001 0 PVT PVT NONE 1
0174426 08/17/2001 GA 11.0 11 M 08/16/2001 Uvula swelled 3-4 X normal size and had difficulty swallowing. No stridor or wheezing. Rx'd with Benadryl and Prednisone. Y Y 08/14/2001 08/14/2001 0 PVT PUB NONE 1
0174427 08/17/2001 MD 1.6 1 .6 F 08/16/2001 Shortly after, pt got home and began with a generalized seizure which lasted about 15 minutes. Called 911 and transported to ER. Temperature was up to 104F but no longer seizing at the time of arrival. Y Y 08/15/2001 08/15/2001 0 CBC and UA-WNL PVT PVT NONE NONE 1
0174428 08/20/2001 IN 1.25 1 .3 M 08/09/2001 Pt had 3 febrile seizures between noon on 8/7/01 and 07:00 on 8/8/01. Admitted for observation/evaluation. Y Y 1 Y 08/06/2001 08/07/2001 1 Normal head CT and normal spinal fluid. PVT PUB NONE NONE NONE 1
0174430 08/20/2001 CA 53.0 51 M 08/13/2001 Pt was in good health until 4/99. He had his 1st Anthrax shot on 4/19/99 and had a sore arm at injection site and a low-grade fever. On 5/1/99, he had his 2nd Anthrax shot; IPPD and Typhoid (was given 2 typhoid shots, due to the medical technician's failure to properly initial off immunization paperwork. When I questioned the medical folks about any possible problems, they just smiled, giggled and laughed, stating now you are double protected. My arm was sore and had a knot from the Anthrax shot. Sinus blocks, inner ear blocks and gland in lower right side of jaw began to swell and this all started 48 hours, post vax. On 5/14/99, I had the 3rd Anthrax shot. Sinus blocks, inner ear blocks and gland swelling continued, now gland on left lower jaw began to swell. These problems remained with me for the months between shot 3 and 4. On 10/14/99, I had the 4th Anthrax shot and still had all the above symptoms, but this time glands in my armpits and back of neck began swelling. I noticed over the proceeding few months weakness and feeling tired all the time. On 4/15/00, I had 5th Anthrax shot and glands in several areas of my body were increasing in size and still had sinus and inner ear problems. Tiring out just walking a short distance; could not sleep well, kept waking up and coughing due to drainage from sinuses. In 9/00, I went to my family physician to see what was going on due to all the items going on with my health. He sent my to follow-up with Hematology and Oncology and a CBC was done and the doctor was concerned about the possibility of a link between Anthrax and my health. I was directed to stop Anthrax series. In 10/00, confirmed Small Cell CLL. 1/01-6/01; 1 week of chemo each month; fludarabine X 4 days and Rituximab X 1 day and medication sulfamethoxazole trimethoprim Tab 800-160, 1 a day was started in 12/99 and will end 9/2/01; Allopurinol Tab 300mg, 1 a day only while under going chemo treatments. 7/01, doctor stopped chemo treatments, blood work was normal, and wished for me to continue antibiotic tab until 9/2/01. At that time, all treatments and medications have been stopped and follow-up visit is scheduled for 10/01. Due to this problem, the military will be recommending removal from service and this will also, terminate my civil service employment. Y Y N 04/19/1999 04/19/1999 0 Blood tests-showed an extremely high WBC with initial signs showing a high probability of CLL. CBC and more test confirmed Small Cell CLL. MIL MIL NONE NONE 1
0174434 08/20/2001 MN 0.75 0 .5 M 11/03/2000 Mom reported on 11/8/00, that on 8/11/00, the day after the vaccines were received, the pt had a temperature up to 103F which lasted 24 hours. Y 08/10/2000 08/11/2000 1 PVT PVT Had just finished Keflex on 8/5/00 Fussy Just had Strep on 8/5/00. 1
0174435 08/20/2001 CA 1.0 1 .0 M 08/10/2001 Pt came back on 8/4/01 with 50mm induration, erythema, tender and warmth at site of varivax vaccination on right anterior thigh. No fever noted. Y 08/02/2001 08/04/2001 2 NONE OTH PUB NONE NONE 1
0174436 08/20/2001 MS 1.08 1 .1 M 08/03/2001 On 7/23/2001, had 4 injections. Mom's history; on 7/28/01, pt had slightly swollen left thigh for 5 days, post vax; on 8/1/01, it was very swollen and tender for 9 days, post vax. At the other facility, on 8/2/01, pt had golf ball-sized lump on left thigh that was firm and slightly tender to touch. Pt was referred to pediatrician for evaluation. He evaluated pt and said he had a 2cm X 2cm firm mass on left thigh and it was not likely to be a reaction to shots but would hold next Prevnar. Y Y 07/23/2001 08/01/2001 9 PUB PUB NONE NONE NONE MS01035 1
0174437 08/20/2001 OH 0.3 0 .4 F 08/13/2001 Swelling and redness at left upper leg. Redness extends from knee to hip and hot to touch. Extreme fussiness from child. She cries whenever leg is touched. Mom to give Tylenol and apply cold compress. Whole thigh from knee to hip involved. Y 08/09/2001 08/09/2001 0 NONE PVT PVT NONE NONE NONE 1
0174438 08/20/2001 OH 0.2 0 .2 M 08/13/2001 Uncontrollable crying for 2 1/2 hours. Also had uncontrollable leg jerking. Y Y 07/23/2001 07/23/2001 0 EEG-pending PVT PVT History of intermittent leg twitching Benign myoclonic jerks 1
0174439 08/20/2001 PA 0.5 0 .5 F 08/10/2001 Erythematous patchy rash on back, a few on face and erythema around the site of the HIB vaccine. Y 08/09/2001 08/09/2001 0 NONE PVT PVT NONE NONE NONE 1
0174440 08/20/2001 OK 0.4 0 .5 M 07/27/2001 Prolonged crying over 8 hours, fever to 103F but doing better. Y U 07/25/2001 07/25/2001 0 CBC with diff ordered PVT PVT Diflucan oral susp X 13 days NONE NONE OK0136 1
0174441 08/20/2001 CA 3.0 3 F 07/26/2001 Pt received Hep-A and Prevnar and within minutes, post vax, pt vomited and fainted. Y 07/12/2001 07/12/2001 0 NONE PVT PUB NONE NONE CA010086 1
0174442 08/20/2001 MN 1.0 1 .0 F 08/16/2001 Fever by maternal report (102F) and irritability. Recommended symptomatic care. Y U 08/14/2001 08/14/2001 0 NONE PVT PVT NONE NONE NONE 1
0174443 08/20/2001 SC 1.5 1 .6 F 08/17/2001 Red spot on right leg, 24 to 48 hours, post vax, with some warmth and edema. Pt prescribed Augmentin. Y Y 08/13/2001 08/15/2001 2 PVT PVT 1
0174444 08/20/2001 ME 0.5 0 .1 F 08/13/2001 Physician reports: "crying/fussy and not consolable for 48 hours, following vaccine." Y 04/09/2001 04/09/2001 0 NONE PVT UNK NONE NONE ME0131 1
0174445 08/20/2001 NY 1.3 1 .3 M 11/08/2000 2 days, post vax, mother noted hives on both legs, not at site of injection. They were scattered on both legs but more on right leg, where Prevnar given. Seen here at 12:50, rash was gone. Y 11/06/2000 11/08/2000 2 NONE PVT PUB NONE NONE 1
0174446 08/20/2001 KS 65.0 64 F 08/14/2001 Received Flu shot in upper back side of left arm involving the ulnar nerve on 11/21/00. By morning of 11/23/00, there was severe pain in my left arm and hand with partial paralysis of both and is continuing to present. The pain in my arm had progressed to the point of not being able to sleep. The MD prescribed steroids and ibuprofen but did not help even with wearing a sling. All the various doctors I have been shuffled to, agree that I have ulnar nerve damage but don't seem to have a clue as to how to treat me. The original doctor stated he had never had this happen and had no idea how to treat me. I've had Flu shots for 15 years without even have flu symptoms as a result of the shot! The MRI, I had approx. 2 1/2 weeks ago, dispelled the theory of my ruptured disc that I had done in 1983! When I walked into that clinic on 11/21/00, there was not one thing wrong with me. I was working and didn't even take an aspirin unless my head was falling off. Needless to say, I lost my job and most of the use of my left hand and arm. I have been to more doctors in the last 7 months than I have in my whole life. I was also prescribed Neurontin and finished this medicine even though it kept me light-headed and dizzy until it was finished. It did nothing for the pain nor bring us any closer to a solution. Then he prescribed more Neurontin and Vioxx but taking Neurontin 3 X a day, kept me feeling as if I was walking in the clouds, continually. Then he stopped the Neurontin and prescribed amitriptyline to be taken at bedtime, as it makes you tired. I was referred to an infectious control doctor. Then my regular doctor prescribed Carbamazepine and he wants to do blood work to see if any of these medications have affected my liver or kidneys. My doctor has now put me on Celexa Citalopram Hbr for the next month and he also gave me a prescription for Valium to take before the MRI to calm me down but I did not take this. The other medication made me sick to the point of hanging over the commode several times. Cancelled all my appointments with this doctor because nothing seemed to be doing any good. Follow up: received flu shot in upper back side of left arm involving the ulnar nerve on 11/21/2000. By morning of 11/23/00, there was severe pain in left arm and hand with partial paralysis of both continuing to present. Y U 11/21/2000 11/23/2000 2 Never conduction with electrodes X 10 and with needles-showing minimal nerve damage; X-ray of arm; MRI PVT PVT NONE NONE Allergies to penicillin and codeine 1
0174447 08/20/2001 CA 58.0 57 F Within 48 hours after the vaccine, I started having joint pains in my hips and shoulders, the pain went down to my elbows, and in after a few weeks the pain moved down to my hands. The pain in my elbows and shoulders has let up but my fingers are getting worse, with some swelling. It is getting difficult to do things like open jars with out alot of pain. I have never had pain like this before. There is nothing listed in the vaccine handout that gives any warnings about arthritis being a side effect of the vaccine. N 11/01/2000 11/04/2000 3 NONE PVT PVT NONE NONE NONE 1
0174448 08/20/2001 TX 4.0 4 F This child had erythema, size 3-4 cm around vaccinated site. Y 09/24/2000 09/26/2000 2 NONE PVT OTH NONE NONE 1
0174449 08/20/2001 FL 48.0 48 F 09/06/2000 An injection was given on 08/01/00. The patient had symptoms of dizziness which progressed to black outs, fainting, muscle soreness, profuse perspiration, excessive thirst, joint fatigue, shaking, trembling after black outs. Y Y 08/01/2000 08/19/2000 18 Blood Work - Normal OTH OTH TB skin test, Connaught, lot # C0018AA, left forearm, 3 previous doses. Prilosec, Estrace. NONE NONE 1
0174450 08/20/2001 GA 4.0 1 .0 M 10/11/2000 This child developed maculopapular erythematous rash with vesicles. Y 11/11/1996 10/11/2000 1430 PVT UNK NONE NONE 1
0174451 08/20/2001 GA 1.8 1 .8 M 10/26/2000 This infant started running a temp of 100.6 the evening of his immunizations. The next morning, 10/20/00, his leg was quite swollen (entire leg). The doctor checked him on 10/21/00, and advised us that the patient had an immunization reaction. Y Y 10/19/2000 10/20/2000 1 NONE PUB PUB NONE NONE NONE The patient had a temp of 103.~DTaP (no brand name)~3~0.00~In Patient 1
0174452 08/20/2001 WI 43.0 43 F 11/09/2000 One (1) day after vaccination in the left deltoid, the patient had diffuse erythema and swelling over much of the deltoid area. Antibiotics started 11/06, by 11/07 her skin had raised edge consistent with erysipelas . Swelling f the deltoid and erythema decreased by 11/09. Y 11/03/2000 11/04/2000 1 PVT UNK NONE 1
0174453 08/20/2001 MA 1.25 1 .3 M 10/13/2000 No data attached. U 10/11/2000 10/11/2000 0 PVT UNK Upper Respiratory Infection ~Vaccine not specified (no brand name)~~0.25~In Sibling 1
0174454 08/20/2001 NY 19.0 19 F 11/09/2000 Received 2nd dose of Varivax on 10/13/00 and then received steroid shot in foot on 10/18/00 by other provider. On 10/15/00, had red papular rash on bilateral forearms X 2 days. Then on 10/21/00, noted erythematous papular rash extending on trunk, upper extremities and face with pruritus X 5-6 days. Treated with Zyrtec 10mg po gd. Y Y 10/13/2000 10/15/2000 2 PVT PVT On 10/18/00, received steroid injection by other provider. NONE NONE 1
0174455 08/20/2001 NY 28.0 27 F 08/14/2001 Cramps in upper thighs X several hours, post vax. Y 06/19/2001 06/19/2001 0 NONE OTH UNK NONE NONE NONE 1
0174456 08/20/2001 NY 28.0 27 F 08/15/2001 Pt had cramps in right foot and upper thighs, bilaterally, X several hours. Y 08/14/2001 08/14/2001 0 OTH UNK NONE NONE NONE 1
0174457 08/20/2001 CA 11.0 11 M 07/26/2001 This child received Hepatitis B and MMR. After second shot the patients eyes rolled back in his head, the patient had LOC, became tense, had jerking movements, and was diaphoretic. The doctor and the nurse assessed the patient. Y Y 07/26/2001 07/26/2001 0 OTH OTH 1
0174458 08/20/2001 CA 18.0 18 F 07/27/2001 This patient had abdominal pain, decreased appetite, diarrhea, elevated liver function tests, and elevated bilirubin, eyes slightly yellow, rash after injection. Seen 13 days after injection, had lab work. Y U 07/10/2001 07/17/2001 7 Elevated liver function, elevated Bilirubin. PVT PVT E-mycin for acne. Lymph Adenopathy - node in neck. 1
0174459 08/20/2001 MA 9.0 9 F 08/11/2001 This patient left to go to the elevator, and said she felt dizzy and fainted approximately seven seconds. BP 90/62 progressing after 5 min 90/68. HR 80, flustered. Had the patient lie down and put legs in the air for 10 min. Recovered fully vasovagal episode. Y 08/03/2001 08/03/2001 0 PUB PUB MOME NONE NONE 1
0174460 08/20/2001 UT 30.0 30 M 08/09/2001 This patient had a high fever of 102, flu like symptoms which began the day following the shot. It lasted 3 days. His arm was sore for 6 weeks after the shot. Y 05/30/2001 05/31/2001 1 PUB PVT NONE NONE Hay fever. The patient had similar symptoms flu like, soreness, and a temperature.~Measles + Mumps + Rubella (no brand name)~~19.00~In Pati 1
0174461 08/20/2001 PA 9.0 3 F 08/13/2001 This child has a mild case of chicken pox, 12 lesions. Y 11/16/1995 08/10/2001 2094 NONE PVT PVT NONE NONE 1
0174462 08/20/2001 TX 5.0 5 F 08/09/2001 After 24 hours of receiving DTAP and IPV in the left deltoid, a red rash with blisters and warmness to the skin 4 1/2" wide by 5" tall appeared. The mom gave Tylenol. Per clinic, the doctor advised Benadryl 1 tsp every 6 hours and Tylenol every 4 hours, and apply cool compress to the area. U 08/06/2001 08/07/2001 1 NONE PUB PUB NONE NONE NONE 1
0174463 08/20/2001 OK 3.0 3 M 07/26/2001 A mother reports a rash on the body of a 3 year old, 1 day after Hep A # 2. The rash was gone in 24 hours. Y 07/18/2001 07/19/2001 1 PUB PUB NONE NONE NONE OK0134 1
0174464 08/20/2001 OK 4.0 4 M 08/03/2001 Child taken to see doctor on 8/1/01. States arm warm, red and swollen. The doctor gave order for Tylenol and warm packs. Y Y 07/31/2001 08/01/2001 1 NONE PUB PUB UNK NONE NONE OK0136 1
0174465 08/20/2001 OK 1.08 1 .1 M 08/03/2001 Suddenly, post vax, multiple erythematous nodules, shown on the injection sites. Then pt had maculopapular rashes spray rapidly from head to toes, then urticaria was noticed. He had loss of muscle tone and response good to Decadron, Epinephrine and Diphenhydramine. Y 07/31/2001 07/31/2001 0 NONE PVT PUB Pharyngitis; Allergic Rhinitis; Contact Dermatitis UNK OK0137 1
0174466 08/20/2001 OK 4.0 5 F 08/03/2001 Redness, swelling and heat at injection site of right deltoid. Instructed to take Tylenol or Motrin and apply cool cloth. If increased redness or worsens, return to clinic or ER. U 07/31/2001 08/01/2001 1 PUB OTH NONE OK0138 1
0174467 08/20/2001 OK 4.0 4 F 08/03/2001 Left deltoid with swelling, redness and heat to touch. Referred to doctor. He ordered pain reliever and apply cold compress. U 07/31/2001 08/02/2001 2 PUB OTH OK0139 1
0174468 08/20/2001 IL M 08/13/2001 DTAP shot given in left arm deltoid area on 8/9/01. Pt developed local reaction with mild induration and swelling. Movements of arm were normal. Y 08/09/2001 NONE PVT UNK NONE 1
0174469 08/20/2001 CA 20.0 20 F 08/09/2001 Pt developed fever, chills and a headache for about 24 to 28 hours, post vax. Y Y 08/08/2001 08/09/2001 1 CBC; Chemistry Panel; UA-all nml PVT PVT Claritin NONE Insect bite Fever~Pertussis (no brand name)~~1.00~In Patient 1
0174470 08/20/2001 NV 41.0 41 F 08/13/2001 Friday evening pt complained of dizziness followed by hoarseness, headache and weakness. Noticed pale skin coloration. She also complained of SOB, beginning on Sunday evening. Client went to see PMD. No Rx's given. Y U 08/10/2001 08/10/2001 0 UNK PUB PVT Claritin; PPD/LFA/0 previous doses which was given on 8/10/01. NONE UNK 1
0174471 08/20/2001 CA 4.0 4 F 08/13/2001 Pt returned for U/A dip. Left arm redness and swollen. Pt was seen through urgent care at site of DTAP vaccine. Pt had a reaction. U 08/10/2001 08/11/2001 1 PUB PUB On 8/8/01 was given PPD/Parkedale/01080P/LFA/1 previously NONE 1
0174472 08/20/2001 OK 12.0 12 M 08/21/2001 Within an hour, pt had a headache, lasting at least 8 hours. Within a few hours, pt had a low-grade fever, paleness and dizziness and had soreness within minutes, lasting several days where shots were given. Y 07/24/2001 07/24/2001 0 PUB UNK 1
0174473 08/20/2001 MD 1.0 1 .0 F 08/13/2001 5 days with fevers to 103.7F and macular rash on face, arms and torso. Y Y 07/31/2001 08/05/2001 5 NONE PVT PVT NONE NONE NONE 1
0174474 08/20/2001 GA 0.2 0 .2 M 08/14/2001 Temperature of 102.2F (R), pale and crying. Went to ER for full work-up, 6 hours, post vax. Y Y 08/13/2001 08/13/2001 0 CBC; Blood culture; CRP; Cath U/A, U/culture PVT PVT NONE NONE Transient tachypnea of new born 1
0174475 08/20/2001 VA 0.3 0 .4 F 08/13/2001 Pt leg crying and irritability, starting 4 hours, post vax. Crying X 15 hours; glazed eyes; vomiting X 2; diarrhea X 4; febrile to 101.2F; decreased movement of left side. Unable to move left leg or arm at all by 04:00 the next day. Resolved by itself in 2 days. Pt examined by MD. Decreased movement on left side noted. No follow-up done. Y Y 08/01/2001 08/01/2001 0 Stool culture lost by MD. PVT OTH Zantac NONE Reflux 1
0174476 08/20/2001 CA 4.0 4 F 06/14/2001 2 cm indurated area on left deltoid. Y 06/14/2001 06/14/2001 0 NONE OTH PUB NONE NONE NONE CA010082 1
0174477 08/20/2001 CA 4.0 4 M 08/01/2001 Post vax, pt had redness and swelling of left arm. Y 04/05/2001 04/05/2001 0 NONE OTH PUB NONE NONE NONE CA010083 1
0174478 08/20/2001 CA 0.75 0 .7 M 08/02/2001 Rash reaction following immunizations on 7/26/01. On 8/6/01, pt had a rash with a fever, lasting 5 days, and started behind ears and spread over the rest of the body including soles of feet. Y Y 07/26/2001 07/26/2001 0 PUB PUB NONE NONE NONE CA010084 1
0174479 08/20/2001 CA 17.0 17 M 07/30/2001 Received the following information from pt's mother during a phone conversation. The pt received Hep-A and Hep-B on 7/19/01 and he also received meningitis vaccine from his PMD that same afternoon. On 7/22/01, the pt developed nausea, headache, fever to 101.5F (usually at night), achy and "hot" joints, and cough. Saw PMD on 7/26/01 and dx'd with "flu". Y Y 07/19/2001 07/22/2001 3 PUB PUB NONE NONE CA010085 1
0174480 08/20/2001 CT 6.0 6 M 08/08/2001 Pt presented back to clinic at 10:40 with questionable dyspnea, urticaria of face, wheezing, O2 sats at that time were 89%. He was given 25mg of Benadryl Elixir at 10:45, applied nasal O2 and given Epinephrine 0.2 ml of 1:1000 sol at 10:45 along with Albuterol nebulizer 0.5cc/2cc NS at 10:50. O2 sats increased to 100% at 10:55 with good aeration and lessening urticaria. Transported to ER with nasal O2 for observation and further treatment. Y Y 08/08/2001 08/08/2001 0 PVT PUB NONE NONE CT200104 1
0174488 08/21/2001 CA 1.5 1 .5 M Mom called doctor's office on 7/31/01, reporting bruising and little red, pin-point spots all over pt's body since the vaccines were given. Pt seen STAT in office and then STAT hospital admission and dx'd with ITP. Follow-up with hematology. Y 2 Y 07/27/2001 07/31/2001 4 CBC, platelet count, PT, PTTT, ESR, all indicated ITP PVT UNK NONE NONE 1
0174490 08/21/2001 AR 1.4 0 .3 M 08/04/2001 Soon after vaccine, pt exhibited symptoms of pain, abdominal stress off and on, especially aggravated by food consumption. His weight gain slowed and he seemed slightly less content. Y Y Y 1 Y 06/04/1999 10/23/1999 141 X-ray; Ultrasound; barium enema PVT PVT NONE NONE NONE fever~Rotavirus (RotaShield)~1~0.00~In Patient 1
0174491 08/21/2001 NY 1.3 1 .3 M 08/06/2001 Within 1 month, post vax, our son withdrew both physically and socially. He lost the few words he had, had absolutely no eye contact and was dx'd with autism. He had severe language delay and also delays in gross fine motor skills with sensory issues. He does not communicate and he has rolling back of his eyes. All within a 30 day period following vaccines. Per doc 207942, in any residual symptom: Autism. The annual follow-up states pt "isolated, withdrawn, non-verbal." Y N 08/13/1999 09/01/1999 19 PVT OTH NONE NONE NONE 1
0174492 08/21/2001 FL 19.0 19 F 08/19/2001 Pt referred via consultation while she was on the Neurology Inpatient Service for evaluation of her "initiation of symptoms following vaccinations during basic training. She presents with concern for development of MS symptoms, post vax, including incidental finding of persistent eosinophilia. She had a nagging toothache for 2-3 months when she joined the US Army on 2/5/01 and it worsened and a tooth abscess was drained 3 days later. A small tooth chip was removed and stitches placed and she was placed on ibuprofen for pain. On 2/12/01, she received 5 shots and within 30 minutes, post vax, she developed a sensation of her right foot "falling asleep". This persisted and 2 days later, had increased to now involve her left leg but she was still able to do physical training (even passing a 1-mile run uphill). Over the next 2 weeks, the "numbness" sensation progressed to involve both hew lower extremities and symmetrically went up to her costal margin bilaterally. She was evaluated with the assessment of paresthesias and suspected neurological disease and neurology consult. She was admitted to the hospital on 3/12/01 but transferred to another hospital on 3/13/01 to 3/20/01 for "increasing symptoms". She was evaluated by neurology and tests. Dx at that time was encephalomyelitis secondary to vaccination. She was treated with high dose steroids. Prior to admission she also complained of headache, nausea and fatigue which almost completely resolved with steroid course. Her paresthesias also diminished although were now confined to her right leg and trunk. She was started on Elavil and Motrin for pain on 4/27/01 and Neurontin and Septra on 4/30/01. She was placed on convalescent leave although during a road march 5-6 weeks after entering basic she developed slurred speech and facial droop and was dx'd with Bell's Palsy. She also had difficulty urinating. The dx of suspected MS was made and she again was treated with IV Solu-Medrol X 5 days and then a 2 week steroid taper. After review of her labs, she was again admitted to the hospital on 7/17/01. During her admission, Allergy/Immunology was consulted to address her vaccine issues and eosinophilia. Summary of symptoms since vaccines: paresthesias X 5 month; headaches X 2 months; fatigue X 5 months; pruritus X 5 months; light-headedness X 1 month; nausea X 3.5 months; intermittent emesis with headache; intermittent Bell's Palsy 4 times. On 8/1/01, was also dx'd with spastic bladder secondary to MS and perennial rhinitis Y Y N 07/22/2001 07/22/2001 0 Lab work on 3/2/01: LFT's, chemistry, CBC, RPR, TSH, B12/folate, FTA-mildly low hgb of 11.6 gm/dL, automated eosinophil % of 4 (nl 0-3; ANC=230) and mild AST elevation of 45. On 3/13/01: CSF studies; MRI head/spine-showed "2 lesions in the CNS and 2 in the spine". On 5/19/01: MRI-showed multiple white matter signal abnormalities in a pattern compatible with multiple sclerosis and also suggestive of active demyelination. On 7/17/01: WBC-5400 cells/mm3, nl hbg, nl plts, increased eosinophil count of 1242 cells/mm, nl chem 7, ESR 15 mm/hr, LDH 567 (313-648), CRP of 0.15 (0.03-5.00nl), albumin 2.8, calcium of 8.1, total protein of 5.6 g/dL. Repeat CBC, after 3 days of IV Solu-Medrol hand no change in eosinophil count; CXR PA/Lateral was nml. Bone marrow biopsy OTH UNK dental abscess GERD; varicella infection as a child; allergy to sulfa (hives) 1
0174493 08/21/2001 IL 2.5 2 .5 M 11/10/2000 I would like to register an adverse reaction to the vaccines my child has received. I cannot give you a form which states 1 vaccine and it's reaction, due to my belief that my son's autism was caused be the inclusion of thermisol preservative contained in most of his vaccines, MMR and DPT, due to their load on his immune system. Here is a list of his vaccines: 1st Hep-B on 12/30/95; DTP-HIB #1 on 3/8/96; OPV/IPV #1 on 4/4/96; #2 DTP-HIB on 5/6/96; #3 DTP-HIB on 5/6/96; #2 OPV/IPV on 6/3/96; #3 DTP/HIB and #3 OPV/IPV on 7/8/96; #3 Engerix-B/2129A2/IM/RL on 9/25/96; #1 MMRII/0473D/SC/LL and #4 HIB-Titer/Praxis/M270PA/IM/RL on 3/12/97; #4 Acel-Imune/444258/IM/LA on 6/13/97; and Fluzone/Pasteur-Merieux/7F81852/IM/RL on 11/25/97. Doc 204161, 60 Day follow up states that patient has autism spectrum disorder, immune disfunction, and many others related biological disorders. Y N 07/13/1998 PVT PVT 1
0174494 08/21/2001 GA 1.4 1 .5 F 08/16/2001 Redness and swelling left thigh. Y 08/14/2001 08/15/2001 1 PVT PUB NONE NONE 1
0174495 08/21/2001 PA 1.2 1 .2 M 08/16/2001 8/6 had immunized, pt healthy at the time. 8/8/01 mom phoned and 1 hour post vaccination the pt had fever of 101.1 with Tylenol and 102 in spite of Tylenol. Pt fussy. 8/11 was taken to ER because of crying, afebrile. On 8/15 rash on him. Y U 08/06/2001 08/06/2001 0 Tine test PVT PUB NONE 1
0174496 08/21/2001 NJ 0.25 0 .2 M 08/07/2001 Persistent crying and high tone shrieking. U 07/26/2001 07/26/2001 0 PVT PVT 1
0174497 08/21/2001 AR 1.3 1 .3 F 08/16/2001 On 8/14/01 AM slight redness and swelling at site, normal per mom. At 4:30 PM noticed quarter size swelling, rock hard and warm to touch. On 8/15/01 at 6 AM there was a large area of right thigh swollen with blisters in center. Noted by Dr on exam at 3 PM on 8/15/01. 12 cm redness with central area 2 1/2 of small vesicles and 1 was broken. Y Y 08/13/2001 08/14/2001 1 PVT PVT NONE NONE NONE 1
0174498 08/21/2001 MI 4.0 4 F 08/02/2001 Pt had a temperature of 106 F. Treated with Motrin. She vomited 3 times. Was seen in ER. She appeared recovered the next day. Y Y 08/01/2001 08/01/2001 0 PUB PUB NONE NONE heart murmur MI2001057 1
0174499 08/21/2001 MI 0.35 0 .4 F 08/08/2001 Continual coughing started 2 hours after shots were given. Temperature up to 104. She was taken to MC. Nausea and vomiting lasted for 2 days. On record to hold pertussus. Y Y 05/23/2001 05/23/2001 0 PUB PUB NONE NONw NONE MI2001056 1
0174500 08/21/2001 RI 0.3 0 .2 M 07/31/2001 That afternoon, post vax, pt ran a low-grade fever and was treated with Tylenol. On 7/27/01, the pt had 2-3 bowel movements which consisted of a green pasty texture with loose stool. On 7/28/01, he had 2-3 bowel movements which were the same and also on 7/29/01. He was anxious while trying to nurse. It would take a couple of times to latch on and then finally nurse. At 16:00, parents noticed purple and red spots and small bruises on his legs (from mid-thigh down to ankles on both legs). Mother remembered reading article on meningitis and knew petechia/purpura were symptoms of a severe form of meningitis. Immediately, she call his pediatrician and he called back, immediately. Upon hearing of marks on the infant's legs, the doctor told mother to immediately take pt to ER. As soon as we arrived, the pt was taken into back room, weighed and temperature taken. He was seen by 2 doctors. He is catheterized for a urine sample and he is given an IV line in his right hand. Several tubes of blood are taken for CBC and other blood clotting test. They dx'd him with petechia and purpura and possible HSP. They told the mother to follow-up with his pediatrician because the infant may have taken a reaction to one of the vaccines, given 6 days prior. He was released to go home. Mother takes pt for follow-up visit and he still has petechia and purpura on his legs and he is also still experiencing several green, pasty textured loose stools today. The doctor reviews all test results from the hospital and determines that the infant appears to have taken an adverse reaction to the pneumococcal conjugate vaccine. She advises mother to watch for fever, vomiting, more petechia/purpura spreading, crankiness, unwillingness to nurse, etc. Advised to contact her immediately if any of these symptoms occur. On 7/31/01, the pt had 2 green, pasty textured loose bowel movements today. He still appears anxious when attempting to nurse but finally latches on and nurses and still has petechia and purpura on legs. On 8/1/01, he had 3 green, pasty textured bowel movements today; still anxious when attempting to nurse and still has petechia and purpura on his legs. On 8/2/01, the pt had 1 green, pasty textured bowel movement and still appears anxious when attempting to nurse and still has petechia and purpura on legs. On 8/3/01, he had normal bowel movements and nursed normally today. On 8/6/01, the petechia and purpura are almost completely gone and on 8/8/01 he is eating and sleeping normally. His stools are normal and the petechia and purpura are now gone from his legs. Y N 07/23/2001 07/29/2001 6 CBC-WNL; electrolytes-nml; UA-nml; PT/PTT-nml; blood culture-neg; urine culture-neg PVT UNK NONE NONE 1
0174501 08/21/2001 FL 1.0 0 1 F 08/14/2001 Increased temperature to 102F-103F and a rash. Y 06/05/2001 08/14/2001 70 PVT PUB NONE 1
0174502 08/21/2001 TX 0.3 0 .2 M 08/15/2001 Pt had a febrile seizure. Y Y 08/09/2001 08/10/2001 1 PVT UNK 1
0174503 08/21/2001 MD 0.75 0 .5 M 08/15/2001 Mom reports, at 9 month visit, pt received vaccines and had a reaction that lasted 6-8 hours with crying, screaming and fever to 103F. Mom reports no redness/swelling at any injection site. Condition resolved by morning. Y 05/11/2001 05/11/2001 0 NONE PVT PVT Mylanta and Maalox Gastroesophageal Reflux Reflux 1
0174504 08/21/2001 TX 1.0 1 .0 F 08/08/2001 Noticed rash on left thigh on 7/31/01. Afebrile. Varicella given on 7/17/01 and had vesicular lesions in semi-circle. No treatment necessary. Seen in office on 8/3/01. Vesicles crusted over. Y N 07/17/2001 07/31/2001 14 NONE PVT PVT Niferex NONE Anemia at 9 months of age; on Niferex. 1
0174505 08/21/2001 NC 0.5 0 .5 M 03/15/2001 Pt had flu symptoms, swelling of leg, fever, high-pitched screaming, lethargic, pale, coughing, sweating and a rash, lasting for 4-5 days. Still has cough and rash. N 03/08/2001 03/08/2001 0 PVT OTH Minor cold and runny nose NONE 1
0174506 08/21/2001 NJ 0.7 0 .7 M 08/14/2001 Pt received Prevnar vaccine on 8/1/01. On 8/7/01, the pt presented with coughing, low-grade temperature, no diarrhea. Erythema was noted on trunk. Treatment recommended was Benadryl X 2 days and Tylenol prn. Pt was also irritable. (Unable to contact parents). Y U 08/01/2001 08/06/2001 5 NONE PVT PVT NONE NONE Right collarbone/clavicle fracture at birth and jaundice at birth 1
0174507 08/21/2001 PA 0.5 0 .5 F 08/10/2001 Pt had erythematous patchy rash on face, back, and a few on extremities. Also had erythema around the site of HIB vaccine. Y 08/09/2001 08/09/2001 0 NONE PVT PVT NONE NONE NONE 1
0174508 08/21/2001 CA 1.0 1 .0 F 08/08/2001 Pt received 12 month set of immunizations on 7/31/01 and developed fever on 8/5/01 of 102F. On 8/6/01, had chills and seizure for 2 minutes. Temperature was 102.2F. Y 07/31/2001 08/06/2001 6 CBC-nml UNK UNK PPD on 7/31/01 1
0174509 08/21/2001 TN 1.08 1 .1 M 07/24/2001 Got severe case of varicella with fever to 104F-105F which started 7 days, post vax. He is recovering. U 07/10/2001 07/18/2001 8 PVT UNK TN01037 1
0174510 08/21/2001 TN 1.6 1 .6 F 08/10/2001 A 19 month old child received 5 vaccines on 8/9/01 in the morning. In the early afternoon, mom called me to report that the baby's breathing was irregular every few breaths, after a hard crying session. Baby fell asleep again and continued the pattern. Mother was concerned that the child was having a reaction to vaccines that were given that morning. Y 08/09/2001 08/09/2001 0 Hemoglobin-10.8 PUB PUB NONE Allergy to milk based products; mother was diabetic while pregnant. TN01041 1
0174511 08/21/2001 NM 7.0 7 M 08/17/2001 Erythema, induration on left deltoid at injection site. Symptomatic treatment recommended. N 08/14/2001 08/16/2001 2 NONE PUB PUB NONE NONE 1
0174512 08/21/2001 AZ 1.5 1 .5 M 08/15/2001 24 hours, post vax, pt broke out into hives. Y 08/10/2001 08/11/2001 1 NONE PVT PVT NONE 1
0174513 08/21/2001 PA 34.0 34 M 08/13/2001 Pt reported hives and throat tightness within 1 hour of receiving Yellow Fever vaccine. Y Y 08/07/2001 08/07/2001 0 PVT PVT Albuterol inhaler prn; Tylenol prn NONE Allergic to pollen and grass. 1
0174514 08/21/2001 AL 53.0 53 F 08/03/2001 One week post vaccination the patient developed 3cm local erythema. Treated with observation. Y 07/25/2001 08/01/2001 7 UNK UNK NONE 1
0174515 08/21/2001 PA 45.0 45 F 08/16/2001 Within 24 hours of administration, the patient complained of local edema and erythema. Forty-eight hours after administration, the patient has a 18cm x 13cm area of induration and inflammation with some urticarial lesions on her chest. The patient was treated with Benadryl and Prednisone. Y U 08/13/2001 08/14/2001 1 NONE PUB PUB NONE NONE NONE 1
0174516 08/21/2001 CT 1.2 1 .1 F 08/16/2001 Five days post vax, the patient developed 6 red papules. U 08/08/2001 08/13/2001 5 PVT PUB Mild atopic dermatitis Atopic dermatitis 1
0174517 08/21/2001 VA 1.5 1 .6 M 08/15/2001 Post vax, the patient experienced local erythema and swelling on the right thigh approximately 5cm x 4cm with a bruised center. The patient was treated with Benadryl, Motrin and cool compresses. Y 08/13/2001 08/15/2001 2 PVT PVT DTaP NONE NONE 1
0174518 08/21/2001 TX 0.2 0 .2 F 08/17/2001 Approximately 9 hours after vaccines, the patient developed fretfulness, rigid arms and severe crying for 10 minutes. Y Y 08/15/2001 08/15/2001 0 NONE PVT PVT NONE NONE NONE 1
0174519 08/21/2001 CA 4.0 4 M 08/15/2001 Post vax, the patient developed a positive skin reaction, 35mm x 35mm. Y 07/30/2001 08/01/2001 2 PVT PVT PPD NONE NONE 1
0174520 08/21/2001 CA 3.0 3 F 08/02/2001 Post vax, the patient's mother called and stated the patient "feels very hot", has little red dots all over her body and red blotches. The rash is most prominent on the right arm and shoulder. The patient complained of arm pain 08/01/2001 in the P.M. The patient was treated with Tylenol and Benadryl. On 08/02/2001 the physician diagnosed the patient with acute exanthem. Y Y 08/01/2001 08/02/2001 1 PUB PUB NONE NONE CA010087 1
0174521 08/21/2001 AZ 4.0 4 M 07/31/2001 Post vax, the patient developed a bright red and swollen wound site on his left thigh. There was moderate tenderness and the patient was afebrile. The patient was treated with Rocephin, Benadryl, Motrin and Augmentin. Y Y 03/28/2001 03/30/2001 2 NONE PVT PVT NONE NONE Repaired cleft lip. ~DTaP (Infanrix)~3~4.00~In Patient 1
0174522 08/21/2001 TX 4.0 4 M 08/10/2001 The day following the vaccination, the injection site was swollen the size of a baseball, red and hot to the touch. It was very hard. The doctor stated it was a "hard local reaction". The patient was treated with Motrin and ice packs and was advised to monitor any other changes. Y 07/05/2001 07/06/2001 1 PUB OTH Singulair; Pulmicort; NONE Asthma; developmental delays; behavioral changes~DTaP (Infanrix)~1~1.50~In Patient|~Measles + Mumps + Rubella (MMR II)~~1.50~In Sibling 1
0174523 08/21/2001 TX 39.0 39 F 08/04/2001 Post vax, the patient developed moderate swelling with erythema and warmth and was severely tender on palpation at the injection site. Y U 08/13/2001 08/14/2001 1 NONE PUB PUB Mantoux NONE NONE 1
0174524 08/21/2001 AR 28.0 29 F 08/13/2001 Post vax, the patient is having difficulty using his left arm. She has no range of motion and can do no lifting. Y U 08/03/2001 08/06/2001 3 PUB UNK Depo Provera; NONE NONE AR0133 1
0174525 08/21/2001 FL 26.0 26 M 08/14/2001 Two minutes after receiving the vaccine the patient felt weak, dizzy and fainted. The patient went to the ER experiencing a fever of 102F, dizziness, tachycardia and right anterior chest pain. The patient was given IV fluids. The patient had diarrhea on 08/14/2001 in the A.M. Y Y Y 08/13/2001 08/13/2001 0 Blood and urine test; Lung scan: Chest x-ray in ER; OTH PUB Multivitamin Headache NONE 1
0174526 08/21/2001 OH 35.0 35 F 08/01/2001 The patient's child received chickenpox vaccine on 07/18/2001. The patient broke out with chickenpox on 07/22/2001. By 07/26/2001 the patient was covered head to toe and by 08/01/2001 scabbed over. The patient believes she touched the area of immunization on her child and got contaminated because the area was wet. Y Y 07/18/2001 07/22/2001 4 UNK UNK Not Vaccinated OH0048 1
0174527 08/21/2001 MN 13.0 13 F 08/16/2001 The patient fainted during administration of HBV. The patient appeared to be looking down, then snored. When spoken to, she awakened quickly. Her pulse was 60 and regular. The patient remained sitting upright but was pale. The patient stated she felt weird, but was alright. Y 08/13/2001 08/13/2001 0 NONE PUB PUB NONE NONE NONE 1
0174528 08/21/2001 NY 4.0 4 F 08/14/2001 The patient's mother states the patient complained of pain in her arm. The next day the patient's arm was red, swelling and feeling hot. The patient was treated with Motrin and Augmentin. A small nodule persists in the left deltoid area. Y Y 07/30/2001 08/01/2001 2 NONE PUB PUB Albuterol; Flovent; NONE Mild, persistent asthma; 1
0174529 08/21/2001 GA 4.0 4 U Post vax, the patient experienced a red rash and welty area on the left thigh which was hot to the touch. U 08/06/2001 08/06/2001 0 PVT PUB NONE NONE 1
0174530 08/21/2001 ID 1.08 1 .1 M 08/01/2001 The patient had a local reaction on the left leg the evening after the immunization in an area over the upper thigh the size of a small baseball. It was red and warm to the touch. The patient was fussy but did not have a fever or other adverse reaction. Motrin was advised for treatment Y 07/30/2001 07/31/2001 1 NONE PUB PUB NONE NONE NONE 1
0174531 08/21/2001 NY 5.0 5 M 08/14/2001 Thirteen hours after the injection the patient experienced a fever and a seizure. Y 08/09/2001 08/09/2001 0 NONE PVT PVT NONE NONE Amox. 1
0174532 08/21/2001 MO 4.0 4 F 08/13/2001 Post vax, the patient developed a hard marble sized knot at the injection site, which was reddened 3cm x 3cm, and warm to the touch. Y 08/06/2001 08/07/2001 1 NONE PUB PUB NONE NONE NONE 1
0174533 08/21/2001 AZ 4.0 4 M 08/06/2001 On 08/01/2001 at night, the patient developed redness, induration and mild tenderness at left deltoid site of DPT shot. Y 07/31/2001 08/01/2001 1 NONE PVT PVT Parkdale PPD; NONE NONE 1
0174535 08/21/2001 CA 5.0 5 M 08/19/2001 Post vax, the patient experienced swelling, redness and pain. The patient was treated with Cephalexin. The patient is still under treatment. N 08/02/2001 08/03/2001 1 NONE PVT PUB NONE NONE NONE 1
0174536 08/21/2001 CA 2.0 2 .0 F 08/10/2001 The patient experienced swelling, redness, pain and was hot to touch on the right thigh where the vaccine was given. The patient was treated with Cephalexin. Y N 08/08/2001 08/10/2001 2 PVT PUB PPD NONE NONE 1
0174537 08/21/2001 IL 31.0 31 F 08/07/2001 Twelve days post injection the patient experienced a sore throat, with a rash at the back of her throat. The patient also had a rash on her face and arms and blisters on her nose and ears. The patient saw her PCP on 08/07/2001 and was treated with prednisone and 4D. The patient feels febrile but has not monitored temp. 07/25/2001 08/07/2001 13 NONE UNK UNK NONE 1
0174538 08/21/2001 VA 45.0 45 M 08/08/2001 On 08/07/2001 the patient noticed swelling of his left arm (deltoid area), tenderness, and hot to touch. The patient returned to the Health Dept to have his arm examined. The patient had a 3-4" area hardened, erythema, and hot to touch, along with 1/2 x 1" bruise at the site of injection. U 08/06/2001 08/07/2001 1 UNK UNK 1st and 2nd degree burns VA01025 1
0174539 08/21/2001 TN 49.0 49 F 07/31/2001 The day following vaccination, the patient experienced redness, swelling and tenderness at the injection site, described by the patient as the size of "half a tennis ball". On day 4, the injection site is less swollen and red. Y 07/27/2001 07/28/2001 1 OTH OTH Multi-vitamin; Advil; Dog bite Hay fever; high cholestrol; TN01038 1
0174540 08/21/2001 TN 1.0 1 .1 M 08/01/2001 On 07/31/2001 a rash suddenly appeared in the A.M. U 07/02/2001 07/31/2001 29 NONE PUB PUB Mantoux tuberculin skin test NONE NONE TN01039 1
0174541 08/21/2001 TN 11.0 11 M 08/08/2001 The patient's mother called on 07/16/2001 to report he had a red itchy rash all over his body, including his face since the day after he received his Hepatitis B vaccine. Reports this rash is exacerbated by heat. The mother described the rash as flat and red. Y 07/05/2001 07/06/2001 1 PUB PUB NONE NONE TN01040 1
0174542 08/21/2001 SC 1.3 1 .3 M 08/20/2001 Seven days post vax the patient began to have a fever of 102-103F for 3-4 days. Ten days after vaccination he developed a maculopapular rash on his chest, abdomen and back. Areas which were additionally affected eyes and ears. The patient has questionable pruritis. N 08/03/2001 08/10/2001 7 NONE PVT UNK NONE NONE NONE 1
0174543 08/21/2001 WA 35.0 35 F 08/17/2001 Post vax the patient experienced a headache, abdominal pain, and chills for 3 days. U 08/14/2001 08/14/2001 0 PVT UNK NONE NONE 1
0174544 08/21/2001 WI 45.0 45 F 08/14/2001 Post vax, the patient developed redness and induration extending beyond the injection site. The patient reports a fever. Y Y 08/08/2001 08/09/2001 1 PVT PVT NONE Nail between fingers 1
0174546 08/21/2001 OH 7.0 6 M 08/13/2001 The patient experienced a low grade fever, sore throat, headache, loss of appetite, chicken pox blisters over his entire body. The patient was treated with Tylenol, fluids, Aveeno baths. The patient was seen at the physician's office on 08/13/2001. Y U 08/03/2001 08/12/2001 9 NONE PVT PVT NONE NONE NONE 1
0174534 08/22/2001 CA 4.0 4 F 08/09/2001 Post vax the patient experienced swelling, redness and pain. The patient was treated with Cephalexin. U 08/06/2001 08/07/2001 1 NONE PVT PUB PPD NONE NONE 1
0174547 08/22/2001 CT 0.08 0 .1 M 08/14/2001 Baby became pale, was not breathing. EMS responded and baby was intubated and transported to ER. Resuscitation was attempted but was not successful. Autopsy report states baby was a twin with left hypoplastic heart syndrome, surgically corrected one week ago and complicated by lung streptococcal infection. Death certificate states cause of death as left hypoplastic heart syndrome. Y 08/14/2001 Y N 08/10/2001 08/14/2001 4 PVT PUB Lasix, Captopril, ASA, Zantac Hypoplastic left heart 1
0174552 08/22/2001 CA 1.5 1 .5 M Onset of discrete papular lesions over lower extremities plus hives within 2 hours, post vax, culminating in Henoch-Schonlein Purpura. Pt was hospitalized. Y 1 Y 08/13/2001 08/13/2001 0 WNL PVT PVT NONE Hives following eating peanuts X 1 1
0174553 08/22/2001 ND 34.0 33 M 08/16/2001 Pt with recurrent, severe muscle spasms starting after 2nd shot. Worse since 3rd shot (2-3 months ago). Persistent, daily, lasting 5 minutes and worse with physical activity. Will check CPK/muscle enzymes, sed rate, kidney, etc. Doc 20416, 60 day follow up, states that patient never came back for follow up, suspect that his symptoms have been resolved. The annual follow-up states "symptoms resolved spontaneously." Y Y Y 02/06/2001 02/21/2001 15 MIL MIL NONE NONE NONE 1
0174554 08/22/2001 WI 35.0 35 F 08/15/2001 After 2 shots of 3, about 8 months on, I started having chronic pain in all my joints. The 60 day follow-up states that the pt still has muscle pain that she never had before and that she is being treated for. The annual follow-ups tates "I still suffer from pain in my joints on hands, legs and arms. I also have chronic muscle pain in legs. Drug therapy has been unsuccessful." Y N 07/01/2000 05/01/2001 304 PUB PVT Zoloft Depression 1
0174555 08/22/2001 1.08 1 .1 M 04/17/2001 Hypotonic, hyporesponsive episode mimicking an non-tonic, afebrile seizure. Pt had a period of apnea (approx. 2 minutes; per parent) that resulted in cyanosis. Y Y 2 Y 03/30/2001 03/30/2001 0 Heat CT-neg; Septic work-up-neg; EEG-nml MIL MIL NONE Bilateral otitis media, 2 weeks ago 1
0174556 08/22/2001 MD 34.0 34 F 08/20/2001 Previously healthy 34 year old black female has had progressively worsening neuro, GI and muscular skeletal symptoms since receiving 7 Anthrax vaccines. After 1st shot, had migraines with 15 to 22 medical visits from 3/19/98 to 6/11/01. She has chronic fatigue; was a runner prior to 2/98 but now barely able to run/walk 1/4 mile. Fibromyalgia, generalized with migratory muscle spasm and pain poorly controlled. Elavil recommended on 7/12/01. Paresthesias with migratory hypesthesia. Anemia with Sickle Trait. GERD with trial of Prilosec with partial relief. She has recurrent symptoms of Vaginitis; self treated with OTC at least 10-12 times/year; candida or bacterial vaginosis documented in chart, never prior to 1998. Situational stress; fear of loss of health, job, quality of life. Anthrax vaccine temporarily exempted X 1 year starting 8/01. She also has GI pains. Y N 12/07/2000 ANA, Anti-DS DNA, ENA, CK-neg/nml; ESR-mildly elevated; Neurologic exam-nml; Hgb A1-low; iron studies-nml; MRI MIL MIL Prilosec 20mg; Elavil 10mg; Imitrex prn NONE Aspirin causes hives; sulfa drugs causes facial itching and rash and penicillin causes hives/rashes. Cesarean section in 1991. 1
0174557 08/22/2001 PA 0.8 0 .9 M 06/25/2001 At 1 1/2 months after receiving the Prevnar immunization, my son was dx'd with Type I Diabetes. He started to show symptoms at 1 month after this shot and was dx'd 1 week after his 1st birthday. Please note this could have been brought on by any one of the vaccinations. I've spoken to a doctor that feels it was the Hep-B vaccine. This is not in our family and he was not sick at all beforehand. The outcome is simple: Type I Diabetes. He was again dosed with Prevnar on 10/12/00 (lot 473043/IM/RL). The annual follow-up states "my son has juvenile diabetes and will for the rest of his life." Y Y 5 Y N 08/28/2000 09/28/2000 31 We have tons of copies from the hospital. PVT PVT NONE NONE NONE 1
0174558 08/22/2001 IN 0.3 0 .4 F 08/17/2001 Knots to both legs, red splotches red to torso and legs. irritability X15-20 minutes. Tactile warmth. Y 08/17/2001 08/17/2001 0 NONE PVT UNK NONE NONE NONE fussy~DTaP (no brand name)~1~0.20~In Patient 1
0174559 08/22/2001 CA 0.5 0 .5 M 08/10/2001 Within 5 weeks post vaccination the pt became pale, monitored with breath rate, was around 20-normal respiration and fully concious. Steadily improved and seemed normal in 15 weeks. Y 08/06/2001 08/06/2001 0 NONE PVT PVT NONE NONE NONE 1
0174560 08/22/2001 ME 5.0 5 M 08/21/2001 Pt developed an urticarial, maculopapular with wheals, rash on trunk mainly, over limbs. Rash occurred 8 hrs after shot. Treated with Benadryl syrup. Y 08/20/2001 08/20/2001 0 PVT PUB NONE Recurrent otitis media (not currently) 1
0174562 08/22/2001 CA 0.3 0 .4 F 08/17/2001 The pt developed a fever the night of vaccination. He developed cough and decreased energy the next day. Then he wouldn't be breast fed and still had a continued fever. He was diagnosed with right sided pneumonia. Y U 08/13/2001 08/13/2001 0 Chest x-ray results showed pneumonia in right lung. PVT UNK 1
0174563 08/22/2001 FL 2.0 1 .8 M 08/17/2001 Pt went to walk in clinic. The Dr said he had a reaction to vaccine. He had a temperature of 105 F, was lethargic and vomiting for 2 days. The pt subsequently recovered. Y Y 05/31/2001 05/31/2001 0 NONE PVT PUB NONE NONE Asthma 1
0174564 08/22/2001 WA 1.8 1 .9 M 08/16/2001 Pt had poor appetite, fussy, decreased eating for 2 days following Prevnar vaccination. Y Y 08/13/2001 08/13/2001 0 NONE PVT PUB NONE NONE NONE 1
0174565 08/22/2001 MN 2.0 2 .3 M 08/16/2001 Pt had hives, rash, itching. He was treated with Benadryl and Prelone. Y 08/16/2001 08/16/2001 0 NONE PUB OTH URI NONE 1
0174566 08/22/2001 AZ 2.0 2 .0 M 08/13/2001 Pt was vaccinated on 08/06/01 and seen on 08/08/01 with parent who reported a rash that started on 08/07/01. Evaluation was multiple maculopapular lesions on face, arms, hands, legs, and trunk. Leg lesions with a surrounding halo of paleness. Y Y 08/06/2001 08/07/2001 1 NONE MIL MIL NONE NONE 1
0174567 08/22/2001 WA 5.0 5 F 08/08/2001 Pt developed 8 cm X 10 cm erythematous, warm reaction at injection site on right anterior thigh. Y 08/06/2001 08/08/2001 2 MIL MIL Zyrtec NONE 2 vessel cord 1
0174568 08/22/2001 GA 2.0 2 .2 M 08/20/2001 Pt developed vomiting, lethargic, neck hurts, local swelling and erythema. Y U 08/13/2001 08/13/2001 0 PVT PVT NONE NONE NONE 1
0174570 08/22/2001 DE 40.0 40 M 08/20/2001 Report 2002019889-1 describes bilateral orchitis and spididymitis in a 40-year-old male who received Lyme disease vaccine recombinant OsPA (Lymerix). The pt had no known drug allergies and received no concomitant medications. His medical history included sialoadenitis in 1996. On 06/18/2001 the pt received his 1st injection of Lymerix, without adverse event. On 07/17/2001, the pt received his 2nd of Lymerix. At 18:00 on 07/18/2001, approximately 24 hours post-immunization, he began to experience chills, aches, and fatigue. The aches included sore throat, achy ribs with radiatin down his back and painful inspiration, pressure in his face and head, pressure behind the eyes, headache, abdominal pain on the right side, and right low back pain. All aches reportedly subsided with rest. On 07/25/2001, ten days post-immunization, he developed fever of 99.9 degrees F., myalgia and severe pain and swelling of the right testicle. On 07/26/2001 he was seen by his physician. A diagnosis of right epididymitis was made and the pt was sent to the ER, where an ultrasound of the testicles showed right-sided epididymitis and small right hydrocele. The pt was prescribed a 10-day course of ciprofloxacin hydrochloride (Cipro) 500 mg and acetaminophen with codeine (Tylenol with Codeine). The fever, myalgia and right testicular pain and swelling resolved by 08/04/2001. On 08/04/2001, the pt developed severe pain and swelling of the left testicle. On 08/06/2001, the pt was seen by his physician. A diagnosis of bilateral orchitis and epididymitis was made. The pt was treated with doxycycline and ibuprofen. On 08/14/2001, the pt was seen by the physician. The bilateral orchitis and epididymitis had resolved. The most recent info was received on 11/05/2001. The physician considered the bilateral orchitis and epididymitis to be severe in intensity, disabling/incapacitating, and relating to Lymerix administration. As a result of this info, the report has been reclassified as serious, unexpected. Y Y Y 07/17/2001 07/25/2001 8 The pt was vaccinated on 06/01/01 and 07/17/01 with 1st and 2nd doses of Lymerix. One day post vaccination the pt started having chills and achy shoulders and felt tired. By 07/20/01 he developed a sore throat and all other symptoms persisted. The pt still felt achy all over, and on 07/22/01 he started feeling pressure in his face and head. He had a temperature of 101 F. He was seen at Dr's office for right testicular pain and right testicular edema. A diagnosis of right epididymitis was made and the pt was sent to the ER for ultrasound. The ultrasound showed right epididymitis and a small hydrocele. He was prescribed medication and the epididymitis resolved. the pt was still experiencing chills, but by 08/14/01 all symptoms had resolved. the Dr told him that he felt that the symptoms described in this report was related to the vaccine. PVT OTH 20010198891 1
0174572 08/22/2001 MO 9.0 9 M 08/14/2001 Pt had facial swelling and generalized urticaria. Y Y 08/09/2001 08/10/2001 1 NONE PVT PUB NONE NONE Asthma 1
0174573 08/22/2001 TN 1.4 1 .4 F 08/16/2001 Pt had maculopapular rash over trunk, back face, and proximal limbs. She also had anterior cervical and post auricular lymphadenopathy. Y U 08/06/2001 08/15/2001 9 NONE PVT PVT NONE NONE NONE 1
0174574 08/22/2001 CA 4.0 4 F 08/15/2001 pt had right arm swelling and temperature within hours of vaccine. Y U 08/14/2001 08/14/2001 0 NONE PVT PUB NONE NONE NONE 1
0174575 08/22/2001 PA 1.2 1 .1 M 08/13/2001 Pt given Varivax vaccine and around 8 or 9 days later developed disseminated papular rash that is pruritic. Low grade fever around 100*101 F. Y 07/31/2001 08/09/2001 9 PVT PUB Viral syndrome 1
0174576 08/22/2001 AL 4.0 4 M Left arm with mild swelling from injection site and warm. Erythematous and pain. Started on Benadryl and Motrin with warm compress. Y Y 08/06/2001 08/07/2001 1 Tuberculin PPD test given. No results reported. MIL MIL NONE NONE 1
0174577 08/22/2001 WA 4.0 4 F 08/14/2001 Pt developed a urticarial rash with itching of lips and perioral area. She had joint swelling and pain. She was treated with Benadryl. Urticarial rash resolved over 24 hours. Joint pain and swelling resolved over 4 days. Y 04/12/2001 04/19/2001 7 NONE PVT PUB NONE NONE 1
0174578 08/22/2001 IN 1.02 1 .0 M 08/13/2001 5 hours post vaccination fever was up to 103 with fussiness and irritability. Fever persisted for 48-60 hours. On 8/6 which was 6 days post vaccination had an episode of decreased alertness, was just staring. Was seen in ER. Pt is currently back to normal state prior to reactions and stable at this time. Y Y 07/31/2001 07/31/2001 0 PVT PVT NONE NONE NONE 1
0174579 08/22/2001 MI 56.0 55 F 08/16/2001 On 05/01 I started having tingling in toe just after I went to bed, but I ignored this. On 5/20/01 I went to hospital for tongue tingling, woke me from sleep and the symptoms still prominent on hospital arrival, but gone by the time I got to see the Dr. On 5/29/01 I began seeing my Dr as soon as possible after visit to the hospital. Other strange experiences was tenseness/tightness in back of neck/head, both left and right. Tenseness in both jaws, numbness in top left lip and numbness in left cheek of face. When laying down at bed time, my heart flutters/ and shallow beating. On 5/30/01 there was a tightness down breastbone one that lasted for at least an hour. I have prickling around left eye socket, left eye visual disturbance. the same evening the back of my head perspired enough to wet hair thoroughly, and significant sweating occurred at other times to-all while sleeping. I awoke some nights feeling hot and had tingling in scalp at site of cut. I have difficulty enunciating and slight hesitation during speaking. I have hoarseness and could not talk loud with numbness in upper throat. I have also experienced occasional bumps that itch which do not look like bug bites, they have been on my face, hand, ankles, knee, and soreness between middle and index fingers on both hands with the left being more dominant. I am experiencing fatigue. Some of the symptoms occurred simultaneously and all lasted from a half hour to 24 hours. Various symptoms occurred everyday day from just before my hospital visit on 5/20/01 until 07/31/01. Was symptom free for about 10 straight days then experienced tingling in right eye which traveled to left eye. All symptoms were more prominent on left side than right. Most disturbances were chest and up. Y U 08/07/2000 05/20/2001 286 MRI on 5/29/01 results normal. Holter Monitor on 0614/01 results normal. Carotid duplex scan with color flow was normal. CT San on 6/19/01 was normal. Angiogram on 7/16/01 is being assessed. Humphrey's test on 6/4/01 showed flaws in eye. M mode and 2 dimensional Doppler echocardiogram, pulsed and color Doppler oh 7/6/01 results were normal. All blood and urine tests results were WNL. Lime disease test were normal. PVT PVT Ogen, provera, vitamin E, multiple vitamins NONE Allergy to ragweed, grasses, trees. Tinnitus and wears glasses 1
0174580 08/22/2001 PA 3.0 1 .0 F 08/15/2001 Began with red papules which increased in size and became vesicular and scabbed. Occuring in crops for several days. U 02/18/1999 08/14/2001 908 PVT PVT NONE NONE 1
0174581 08/22/2001 IN 3.0 1 .1 F 08/16/2001 Pt developed shingles on 8/16/01 and had Varivax on 03/16/1999. Y 03/26/1999 08/16/2001 874 NONE PVT PVT NONE NONE NONE 1
0174582 08/22/2001 TN 2.0 2 .0 F 08/13/2001 pt had d3 cm of erythema and mild induration and warmth at site of immunization. U 07/11/2001 07/16/2001 5 PUB UNK none NONE 1
0174583 08/22/2001 MD 59.0 60 F 08/09/2001 Pt received routine Pneumovax to deltoid area in AM. Returned approximately 51/2 hours later with complaints of swollen, warm, tender right upper arm. Pt also complained of nausea. Slight pain remains at site on 08/15/2001. Y Y 08/09/2001 08/09/2001 0 PVT PVT NONE Asthma 1
0174584 08/22/2001 WI 1.25 1 .3 M 08/17/2001 Pt's right thigh red, swollen, indurated X 4 days. Treated with warm packs, Tylenol, observation. Y Y 08/13/2001 08/14/2001 1 NONE PVT PUB NONE NONE 1
0174585 08/22/2001 NE 0.4 0 .4 F Post vax, the patient had a period of hypotonia, was overwrought and unconsolable and vomited frequently. She was seen 03/13/2001 and was better. Y Y 03/12/2001 03/12/2001 0 NONE PUB PUB NONE NONE NONE 1
0174586 08/22/2001 HI 4.0 4 M 08/02/2001 Two days post vax, the patient returned with localized redness. The patient's right deltoid had an area of red induration 4 x 2 inches. The patient's left arm had an area of red induration 2 x 2 inches. Y Y 07/31/2001 08/02/2001 2 NONE PVT PVT PPD 1
0174587 08/22/2001 IN 12.0 12 M 08/14/2001 5 days after immunization pt seen for right testicular pain and swelling. Onset of symptoms approximately 8/5. Dr felt to be unilateral orchitis. Relation to vaccine unknown. Y U 08/02/2001 08/05/2001 3 8/8/01 Doppler flow right testicle results inflammation. Radio Nuclide scan on 8/10/01 was negative. PUB PUB NONE NONE NONE 1
0174588 08/22/2001 OH 1.52 1 .5 M 08/15/2001 Local reaction. N 08/13/2001 08/14/2001 1 NONE PVT PVT NONE Eczema NONE 1
0174589 08/22/2001 CA 7.0 7 F 08/15/2001 Pt has redness at site of injection and fever to 104.1 for 2 nights. The pt also has vomiting, diarrhea and anorexia. Supportive care was given. Y 07/17/2001 07/18/2001 1 NONE PVT PVT NONE NONE 1
0174590 08/22/2001 PA 3 F 08/15/2001 Swelling and tenderness in left deltoid, with possible cellulitis entire upper left arm. U 08/13/2001 08/13/2001 0 NONE PVT UNK NONE NONE 1
0174591 08/22/2001 MI 19.0 19 M 08/16/2001 In for Menomune vaccine on 07/18/01. On August 4th after he marched in 2 band performances outside, his temperature ranged from 90's-100's. Client became nauseated, chilled, and a severe headache. Went home to bed and temperature at that time was 102.5 headache, nausea; went to ER with parents after long wait was afebrile in ER. Went home and several days later was back to normal. Y Y 07/18/2001 08/04/2001 17 Blood work at ER on 08/03/01 all WNL's PUB PUB NONE NONE 1
0174592 08/22/2001 MI 3.0 1 .0 F 08/15/2001 the pt came into our office for a rash and mild headache. Rash was dx as varicella on 08/15/01 at our clinic. Follow up on 09/19/2001: "No record on chart of vaccine #'s or lot #'s. Immunizations given at a different office. The copy of personal immunization record shows they were given at another address." Y U 11/17/1998 08/15/2001 1002 PVT OTH NONE NONE 1
0174593 08/22/2001 CA 48.0 48 F 08/16/2001 Pt received Pneumovax on 8/13/01 in right deltoid. Patient described extreme redness and splotchy red raised bumps with tenderness. On return to clinic on 8/16/01, still slight red splotchy areas observed. Pt reported no systemic symptoms. Y Y 08/13/2001 08/13/2001 0 PVT PUB Serevent, Albuterol NONE Asthma, pollen allergy 1
0174594 08/22/2001 WA 5.0 5 M 08/16/2001 Fever to 102 for 24 hours following immunization. Induration 6 cm X 5 cm at site of DTAP with 10 X 5 cm erythema and pruritis at injection site. U 08/14/2001 08/14/2001 0 NONE PVT PUB NONE NONE Atopic dermatitits 1
0174595 08/22/2001 FL 48.0 49 F 08/16/2001 Pain in shoulder areas, increased weakness, pale, dizzy on 8/1/01 on 8/2/01 early AM had respiratory difficulty, severe lightheadness, weakness, fainting. BP 190 over 100. Taken to ER for symptoms. Y Y 07/31/2001 08/01/2001 1 PUB PUB NONE Hepatitis C 1
0174596 08/22/2001 OH 4.0 4 F 08/16/2001 Post vax, the patients arm was red, warm and black and blue above and below the injection site. On 08/15/2001 the patient was treated with Tylenol, Duricef and ice packs. On 08/16/2001 the patient's mother advised the patient is much improved. Y 08/13/2001 08/15/2001 2 PVT UNK NONE NONE 1
0174597 08/22/2001 CA 3.0 3 F 08/15/2001 Post vax, the patient experienced tenderness and redness at the site of injection. Supportive care was given. Y 07/17/2001 PVT PVT Allergic rhinitis 1
0174598 08/22/2001 PA 3.0 1 .3 M 08/15/2001 The physician diagnosed shingles on 08/14/2001. The patient had multiple erythematous papules following dermatome of the right arm. The patient complained of pain in the right axilla and hand. The patient was treated with Bovirax. U 02/23/1999 08/12/2001 901 PVT PVT Asthma; recurrent OM 1
0174599 08/22/2001 CA 3.0 1 .0 M 08/14/2001 The patient had chicken pox on 06/28/2001. Y 02/12/1999 06/18/2001 857 Immunoglobulins a, g, m OTH PVT NONE NONE NONE 1
0174600 08/22/2001 KS 59.0 59 F 08/15/2001 Post vax, the patient developed hives which started under the left arm and continued to spread until her body was covered. The patient saw a physician on 07/27/2001 through 08/01/2001 each day. Y Y 07/25/2001 07/27/2001 2 PUB PVT TB skin test; Synthroid; Triestroges cream; Progesterone cream; NONE Thyroid 1
0174601 08/22/2001 PA 1.0 1 .0 M 08/13/2001 On 08/04/2001 the patient developed a low grade fever, 100F and presented in the physician's office on 08/06/2001 with a developing generalized rash. Y 08/03/2001 08/04/2001 1 PVT PUB Left Otitis Media NONE 1
0174602 08/22/2001 WA 51.0 51 M 08/15/2001 Post vax, the patient developed an 8cm area of redness and warmth at the injection site. U 08/14/2001 08/14/2001 0 NONE PVT UNK NONE NONE 1
0174603 08/22/2001 CA 0.08 0 .1 F 08/17/2001 Within 3 hours of vaccination, the patient developed severe diarrhea and has continued with diarrhea, now 5 days. Y N 07/20/2001 07/20/2001 0 Stool studies for culture, giardia, O/Px3 and rotavirus all negative PVT PVT NONE NONE NONE 1
0174604 08/23/2001 CO 34.0 34 F 08/20/2001 Information has been received from a consumer concerning his 34 year old wife with no past medical history who on approx. 9/19/00 or 10/05/00 was vaccinated with 1 dose of MMRII (lot 05821L invalid). There was no concomitant medication. The consumer stated that his wife was approx. 5 days pregnant at the time of vaccination. Follow-up information from a physician stated, "(The pt was) lost to follow-up" and "probably had an abortion". No further information is expected. 09/19/2000 OTH OTH NONE Pregnancy (LMP-UNK) WAES00101728 1
0174609 08/23/2001 NJ 0.2 0 .2 F 08/16/2001 A 2 month old female pt had routine vaccines, including Prevnar, and developed a fever, 8 days, post vax, of 101.9F; perforated tympanic membrane and otitis media which grew pneumococcus. Y 4 Y 06/18/2001 06/26/2001 8 Blood culture-neg; typing not done. Ear drainage culture grew pneumococcus. PVT PVT NONE NONE 1
0174610 08/23/2001 NY 0 .0 M 08/09/2001 Newborn boy received Hep-B vaccine (5mg IM). Less that 10 minutes, post vax, RN noticed baby was cyanotic. Pt was stimulated and given O2 by face mask. The baby responded and was transferred to NICU. Baby was discharged on 7/15/01. Y 2 Y 07/13/2001 07/13/2001 0 UNK UNK Erythromycin ophthalmic ointment; phytonadione 1 mg, IM NONE 1
0174611 08/23/2001 ME 1.5 1 .5 F 08/16/2001 Pt had an enlarged erythematous wheal around injection site on right thigh. Pt also has a temperature of 101 F and vomiting and dizziness. Y 08/15/2001 08/15/2001 0 NONE PVT PUB ANONE NONE NONE cellulitis~Pneumo (Prevnar)~2~0.80~In Patient 1
0174612 08/23/2001 PA 0.25 0 .2 M 08/17/2001 Immediately, post vaccinations both sole of feet turned bright pink. lower extremities slightly pink also. Within 2-3 minutes color began to turn normal when laid him down. When held uprigh, turned bright pink again. Y 08/16/2001 08/16/2001 0 NONE PUB PUB rash on body NONE 1
0174613 08/23/2001 NH 0.2 0 .2 F 08/21/2001 Seen in office on 8/16/01 and Mom reported at that time that on 8/8/01 from approximately 2 PM to 4:20 PM pt had temperature of 98.3 to 101 F. Baby was screaming then became a zombie. Flaccid, staring, pale but no cyanosis. Responded to Tylenol within 30 minutes. Y 08/08/2001 08/08/2001 0 NONE PVT PUB NONE NONE NONE 1
0174614 08/23/2001 WI 1.4 0 .3 M 01/24/2000 After 2nd dose of rotashield, the pt experienced severe gassiness. The pt only gained 12 oz from his 4 month to his 6 month checkup. He cried all day, every day for 2 months straight from the day following the 2nd dose. U 01/05/1999 01/06/1999 1 PUB UNK NONE NONE NONE 1
0174615 08/23/2001 OH 5.0 5 F 08/20/2001 The pt woke up crying on Friday night with a red raised rash over both legs and thighs on her stomach and in between her fingers. This rash itches. Mother gave topical Benadryl and an aveno bath. Rash is subsiding but still is present. U 08/16/2001 08/25/2001 9 NONE PUB PUB NONE NONE 1
0174616 08/23/2001 NY 0 .0 M 08/09/2001 Newborn received Hep B vax and fifteen minutes later the baby was cyanotic and not breathing. The child was stimulated and given O2 via face mask, then the baby turned pink and was transferred to NICU and discharged the following day. U 08/01/2001 08/01/2001 0 UNK UNK Erythromycin ophth oint, phytonadione NONE 1
0174617 08/23/2001 DC 52.0 52 M 08/16/2001 Following 2nd dose of Hep B, the pt complained of runny nose, cough, sensation of heat in head, nausea and sometimes vomiting. No improvement with Motrin. U 04/25/2001 04/26/2001 1 UNK UNK 1
0174618 08/23/2001 MD 1.08 0 .1 M 08/17/2001 1 day post vax, the pt developed a generalized macular rash to the face, trunk, and extremities. No fever, vomiting or diarrhea. Y 08/15/2001 08/15/2001 0 NONE PVT PVT NONE NONE NONE 1
0174619 08/23/2001 CA 11.0 11 F 08/21/2001 Follow vax, at approximately 10:45 the pt began having difficulty breathing, mom was instructed to call 911. The pt was taken to the ER, was treated and released. The pt ate 2 donuts post vax and got sick. Y Y 08/21/2001 08/21/2001 0 PUB OTH NONE NONE NONE 1
0174620 08/23/2001 KY 4.0 4 M 08/22/2001 The child developed periorbital edema, generalized facial swelling, generalized rash with drooling. approximately 30 minutes post vax. No wheezing was observed. Treated in ER with steroids and Benadryl. Y Y 08/21/2001 08/21/2001 0 CBC and BMP PUB PUB NONE NONE speech disorder, developmental delay, premature birth. 1
0174713 08/23/2001 GA 4.0 4 M 08/17/2001 On 8/17/01, pt's arm was red and swollen. He was put on RX Duricef 500mg 3/4 tsp BID X 7 days. Y Y 08/15/2001 08/16/2001 1 PVT PUB 1
0174624 08/24/2001 MA 1.25 1 .3 M 02/26/2002 A mother reported that her son, now 4 years old, received HIB and MMRII vaccines on 9/15/98, at 15 months of age. He subsequently, developed a fever of 104F that lasted for 3 days. He also developed a measles-like rash that was "dx'd by the HCP". The reporter noted that prior to vaccine administration, her son showed signs of "sensory integration," and he was usually difficult to console. Six months, post vax, the child was dx'd with autism. Autism was considered "Medically Important". No further information was available at the date of this report. Follow-up info was obtained from the physician. this child is one of triplets (2 female, 1 male). When he was 5 months old, he was referred to a developmental clinic because his mother noted he was frequently inconsolable and "behind his sisters in motor skills." The child continued to fall behind developmentally and before he was 2 years old, he was referred to a specialist. A confirmation of pervasive developmental delay was made. The physician indicated that the child is receiving treatments and services and "is improving and doing much better now." Additional info received from the pt's relative noted that on an unknown date the pt developed fever, measles-like rash and autism. The pt's fever, measles-like rash and autism were considered to be other important medical events. Additional info has been requested. U 09/15/1998 UNK PVT PVT UNK UNK WAES01104473 1
0174634 08/24/2001 IA 18.0 18 M 08/08/2001 Pt was about to graduate from high school. Pt had college form to fill out, re: health status. Hepatitis B vaccine was suggested. Pt received 1st injection 3/16. 2nd-4/17/2000. In May 2000, pt was admitted to the hospital with acute cerebritis that required steroid therapy.The steroid therapy ultimately lead to aseptic necrosis of hips . Pt had had dental surgety and had draining sinuses. 60 DAY FOLLOW UP STATES: Pt has not recovered. Ataxia. Post vaccination cerebellitis started 04/10/2000. Y Y 20 Y N 03/16/2000 05/08/2000 53 Spinal Tap; EEG PVT PVT NONE NONE NONE 1
0174635 08/24/2001 TX 4.0 4 M 08/07/2001 Mother brought child into the clinic 2 days, post vax. His right upper arm was bright red, warm to the touch and hard with a small bump noted. Mom stated she has been giving him Tylenol. Instructed her to take him to the hospital; gave her directions. Mother took child to ER and they admitted him to the hospital, have him an IV and administered antibiotics. He stayed overnight. Talked with mother on 8/6/01 and child's right arm looks very good. Y Y Y 08/01/2001 08/03/2001 2 UNK PUB PUB TX01109 1
0174636 08/24/2001 TN 1.0 1 .0 M 08/16/2001 9 days, post vax, pt had multiple partial seizures, including abnormal movement with fever and vocalizations with flapping of arms. Apparent seizing resolved after about 7 days. Y 2 Y 07/20/2001 07/29/2001 9 EEG was normal PVT PVT NONE NONE NONE 1
0174637 08/24/2001 TX 1.6 1 .5 F 07/18/2001 This infant developed hives all over his body, eyes swollen, no respiratory involvement. Diagnosed with ear infection when taken to the ER. No fever. Y Y 07/17/2001 07/17/2001 0 NONE OTH PUB Diagnosed with ear infection later that day. NONE TX01099 1
0174638 08/24/2001 TX 1.4 1 .4 M 07/23/2001 Right thigh swollen, feels warm, red and irritated. Applying Benadryl ointment. U 07/20/2001 07/20/2001 0 PVT PVT NONE NONE 1
0174639 08/24/2001 TX 3.0 3 F 08/10/2001 Post vax, child was anorexic. During the night, she became very restless and uncomfortable. Mom couldn't detect a fever. The next morning, leg was swollen and tight at injection site, warm to touch though not red. Child awoke crying and remained extremely irritable all day long. She complained of pain and was unable to bend her leg or walk on it. She cried the greater part of the day and was not interested in eating. That evening, she showed interest in food. The next day, she continued to complain of pain and was unable to bend her leg. By 8/9/01, she began to bear weight on leg and by 8/10/01, she seemed to be completely recovered. Y 08/07/2001 08/07/2001 0 NONE PVT PUB NONE NONE Allergy to milk and cheese. TX01113 1
0174640 08/24/2001 TX 4.0 4 M 08/01/2001 Pt developed raised, red area that was painful to touch. Able to walk without pain or difficulty. Instructed mom to seek PCP and advise as well as instructing mom to use Motrin every 6 hours and ice. U 07/30/2001 07/31/2001 1 PUB PUB NONE NONE NONE TX01107 1
0174641 08/24/2001 TX 2.0 2 .0 M This child had local soft edema above, below, and medial to the left patellar as well as the left thigh. No induration, no significant erythema, no fever, full range of motion and weight bearing. Noted 24 hours after vaccine. Y Y 07/25/2001 07/26/2001 1 CBC, BP, Sed Rate 07/26/01. PVT PUB Triamcinolone cream. Eczema. Eczema TX01106 1
0174642 08/24/2001 TX 1.0 1 .0 M 07/30/2001 Pt developed some vesicles and maculopapular rash of torso. Y U 07/16/2001 07/26/2001 10 PVT PUB PPD/Aventis/C0579AA/LFA/0 previously NONE TX01105 1
0174643 08/24/2001 TX 1.0 1 .0 F 08/02/2001 This infant had pox lesions. 1 week after receiving the vaccine. Y U 07/18/2001 07/28/2001 10 PVT PUB PPD NONE NONE TX01104 1
0174644 08/24/2001 TX 1.25 1 .3 M 01/20/2001 Mom states fever since 07/10/01, but no temp was taken. Client fussy and crying alot. Denies redness at the sites and no knots felt under the skin. Cold compress applied and temperature medicine given. But couldn't tell us the name of the temp medicine. Asked the mother to call back with a temp by 2 pm today 07/16/01 and the name of the temp medicine. At 2 pm no response from the mother. On 07/17/01, by interpreter, the client was having a fever especially at night and since 07/10/01. Told to take the client to the doctor the dad stated he will when the mother gets home from work today at 5 pm. Tried several times to reach the client, unable; messages left on a recorder dates 07/18/01 and 07/20/01. Y 07/10/2001 07/11/2001 1 PUB PUB NONE NONE NONE TX01102 1
0174645 08/24/2001 TX 0.7 0 .7 M 07/06/2001 This infant had a rash on his face and entire body. He had a fever the day of his immunization and the day after. No fever since 07/04/01. The rash started the day 07/04/01. No reactions. Referred to CMC. Y Y 07/03/2001 07/05/2001 2 PUB PUB NONE NONE TX01095 1
0174646 08/24/2001 TX 4.0 4 F 07/05/2001 This child had redness approximately 11 cm surrounding PCV& left anterior thigh at the injection site. The mother states it was warm and red yesterday (07/04/01). Y 07/02/2001 07/04/2001 2 NONE UNK UNK PPD, Lot # C0631AA, Intradermal, left forearm, 2 previous. NONE TX01094 1
0174647 08/24/2001 TX 4.0 4 M 07/03/1997 This child had a swollen leg, right anterior thigh slightly warm, firm, erythema, edema (13cm x 13cm). Full range of motion, full weight bearing. Treatment: ice packs to the thigh, Benadryl next 24 - 48 hours for elevated erythema, decrease range of motion, or fever call doctors office or go to the ER. Emergency hours and # given to the mom. Y Y 07/02/2001 07/02/2001 0 PVT PUB NONE NONE History of mild intermittent TX01093 1
0174648 08/24/2001 CA 0.5 0 .5 F 08/25/2001 Pt developed difficulty breathing, puffy eyes, watery eyes and slight discharge from nose. Y Y 08/02/2001 08/03/2001 1 NONE PUB OTH Tylenol NONE NONE 1
0174649 08/24/2001 NJ 0.5 0 .3 M 08/22/2001 On 6/11/01, pt received DT, HIB, IPV and Prevnar and within 1 hour, pt had 4 hours of uncontrollable crying. At 4 month shots, pt had 4 hours of uncontrollable crying, same shots. On 4/17/01, pt had DTAP, IPV, HIB and Prevnar and had 3 hours of uncontrollable screaming. Y 06/11/2001 06/11/2001 0 PVT UNK NONE NONE 1
0174650 08/24/2001 NJ 0.5 0 .2 M 08/22/2001 On 4/17/01, post vax, pt had 3 hours of inconsolable screaming. Y 04/17/2001 04/17/2001 0 NONE PVT UNK NONE NONE 1
0174651 08/24/2001 PA 0.2 0 .2 M 08/16/2001 Post vax, pt had inconsolable crying X 1 to 1 1/2 hours. U 08/15/2001 08/15/2001 0 PUB PVT NONE NONE NONE 1
0174653 08/24/2001 GA 4.0 1 .6 F 08/22/2001 This child presented in the office with 5-6 vesicles on her trunk day # 1 today 08/22/01. Typical chicken pox lesions. Had vaccine 02/07/99. Y Y 02/07/1999 08/22/2001 927 PVT PVT 1
0174654 08/24/2001 OR 4.0 4 M 08/16/2001 30 minutes after receiving his vaccine, this patient became pale and fainted. His temperature was 102. No evident seizure activity. He had "fever" right prior to the well-check (temp not taken). Y Y 08/15/2001 08/15/2001 0 NONE UNK PVT NONE Fever right before vaccination. Hive reaction to Cetotaxine, and Augmentin. 1
0174655 08/24/2001 NV 4.0 4 M 08/10/2001 This child's arm was red and warm from the shoulder to the mid arm upper side only. The grandmother is instructed to use hot packs and Tylenol. U 08/09/2001 08/10/2001 1 PVT PUB NONE NONE NONE 1
0174656 08/24/2001 MI 38.0 29 F 07/10/2001 This patient began having vague flu like aches 1/2 hour after receiving vaccine. Four hour later she had a temp of 100, very bad flank pains, and nausea (mild). Y Y 02/06/1992 02/06/1992 0 Rubella titer prior to vaccine was greater than 500. It remains greater than 200 to this day. PUB PUB NONE Suprax 1
0174657 08/24/2001 MI F 07/10/2001 This patient had URI's, low grade temps, frequent swollen lymph nodes, 3 spontaneous abortions, very low protein count with pregnancy. Spots on arms developed (now diagnosed with autoimmune progesterone dermatitis), night sweats. Now diagnosed with sticky platelet syndrome, elevated factor VIII + XI, elevated TAT, + Anticardiolipin Antibodies. Y Y NONE PUB PUB NONE UNK Suprax 1
0174658 08/24/2001 GA 3.0 3 M 08/16/2001 Mother here with child wishing the nurse to view the left leg where the child received DTAP 08/14/01. The left leg noticeably swollen compared to the right leg. The mother states the child is complaining of knee pain. The child has red raised irregular area on the left leg. Has history of staph infection involving surgery to the right thigh. The child very active and activity level uncompromised during the visit. The nurse referred the patient to the doctor ASAP. U 08/14/2001 08/15/2001 1 PUB PUB NONE 1
0174659 08/24/2001 TX 9.0 9 F 07/27/2001 This patient's mom states patient has redness, swelling, small red red bumps, and complains of itching to the site where the Hep A shot was given. Treated with Hydrocortisone cream. U 07/25/2001 07/26/2001 1 PVT PVT 1
0174660 08/24/2001 TX 4.0 4 F 07/27/2001 The mother of this patient states the child had redness, warmth, pain, and swelling the size of the mom's hand at the injection site of the Hep A on the child's leg. The mother noticed this Am. The mother states treating child's pain with Tylenol every 4 hours. U 07/26/2001 07/27/2001 1 PVT PVT NONE NONE NONE 1
0174661 08/24/2001 TX 4.0 4 M 07/20/2001 This patient had an IPV in the right lower thigh, now swollen, 4 x 4 1'/2 inch, Also red and irritated. U 07/16/2001 07/17/2001 1 PVT PVT 1
0174662 08/24/2001 TX 48.0 48 F 08/13/2001 Rash on neck and feels like throat is swelling. Rash is spreading to arms. Treated with Solu-Medrol 125mg, IM X 1 stat and Prednisone 20mg 3 X po X 4 days and Hydroxyzine 25mg every 6 hours prn. U 08/09/2001 08/10/2001 1 NONE PUB PUB NONE Allergy to PCN, Rocephin, Sulfa, Codeine and Keflex. TX01116 1
0174664 08/24/2001 TX 5.0 5 M 08/08/2001 On 8/6/01, pt was inadvertently given DTAP, instead of DT and mom was instructed to watch child closely and let us know how the child is doing tomorrow. On 8/7/01, mom here and states that child had a temperature of 104F last PM and was treated with Tylenol and cool baths. Had doctor's visit today and was instructed to continue with fever medication and heat treatments to right axillary area. They are to call LMD if rash develops. On 8/8/01, per telephone call from mother; she states that the pt's temperature is down to normal range and that now he has muscle cramps and that the lymph nodes are still swollen under his right arm. Asked mother to continue to observe and notify LMD if condition worsens or further questions. Y Y 08/06/2001 08/06/2001 0 PUB PUB NONE NONE Hypospadias; repaired surgically at 6 months of age Unspecified reaction~DTP (no brand name)~2~0.30~In Patient TX01114 1
0174665 08/24/2001 TX 4.0 4 M 08/08/2001 Pt given MMR #2 and after approx. 10 minutes, developed 1 hive approx. 10mm X 10mm. He was given 2 1/2cc po Benadryl at 09:50; (subsided at 10:10). Y 08/08/2001 08/08/2001 0 NONE PUB PUB TX01112 1
0174666 08/24/2001 TX 5.0 5 M 08/02/2001 Site of injection for DTAP was red, warm to touch and swollen. Pt complained of itching at site. U 07/31/2001 07/31/2001 0 PUB UNK PPD/Aventis Pasteur/C0579AA/ID/LA/0 previously Allergies to beef, oak, milk, and eggs. TX01111 1
0174667 08/24/2001 TX 14.0 14 M 08/07/2001 Pt received Hep-B immunization #1 in the early afternoon and by that evening, he had a rash all over both arms, both legs and torso. It was red and itchy. No SOB, lip swelling or difficulty breathing. Y 08/06/2001 08/06/2001 0 NONE PVT PUB NONE NONE NONE TX01110 1
0174668 08/24/2001 TX 10.0 10 F 07/28/2001 Pt's right arm developed redness and pt complained of discomfort. U 07/26/2001 07/27/2001 1 PUB PUB Zithromax for Tinea pedis with a secondary bacterial infection Tinea pedis with a secondary bacterial infection Tinea pedis with a secondary bacterial infection TX01103 1
0174669 08/24/2001 TX 2.0 2 .5 F 06/28/2001 Mom reports observing child's right leg on 6/27/01, at which time, it was red and hot to touch. Mom stated she started range of motion to the right leg and gave Motrin, .4cc. No vomiting, fever or diarrhea observed. Today, mom in clinic and reports right leg (RLT) less tender, also states leg not as hot but appears more firm and hard. Y 06/26/2001 06/27/2001 1 NONE PUB UNK NONE NONE TX01101 1
0174670 08/24/2001 TX 5.0 1 .2 M 07/20/2001 Seen in clinic on 7/13/01 and dx'd with varicella. Scalp, face, anterior and posterior trunk with diffuse maculopapular pinkish lesions. Y 06/16/1997 07/12/2001 1487 NONE PUB PUB NONE NONE NONE TX01100 1
0174671 08/24/2001 TX 1.25 1 .2 M 07/20/2001 Pt given varicella and approx. 10 minutes later, developed an 1cm hive below the injection site (2cm). He was given 1 tsp of Benadryl po at 10:25. Mom was advised to watch arm carefully. Y 07/20/2001 07/20/2001 0 PUB PUB NONE NONE TX01098 1
0174672 08/24/2001 TX 2.0 2 .8 M 07/19/2001 Pt developed chickenpox rash 10 days, post vax. Also, with fever. Mom states the rash is mild. U 07/09/2001 07/18/2001 9 NONE PUB UNK NONE NONE TX01097 1
0174673 08/24/2001 TX 4.0 4 M 07/11/2001 Pt's right thigh was swollen with redness and feels hot X 1 day. Y 07/09/2001 07/09/2001 0 PVT OTH NONE NONE TX01096 1
0174674 08/24/2001 NY 17.0 17 F 08/17/2001 Symptoms began approx. 17:30 on 8/14/01 with nausea and fatigue. On 8/15/01, the pt had chills, fever, muscle pain (neck and legs), SOB, chest constriction, headache, diaphoresis and unable to sleep. On 8/15/01, developed SOB. On 8/16/01, had muscle cramps and chest discomfort and on 8/17/01, had muscle pain and chest discomfort. Appt. scheduled for 8/17/01. N 08/14/2001 08/14/2001 0 PVT PVT Retin-A cream .0257 NONE Leg paralysis~Measles + Mumps + Rubella (no brand name)~1~5.00~In Patient 1
0174675 08/24/2001 PA 1.08 1 .1 F 08/20/2001 Mom states called on 8/16/01 and stated child broke out with about 23 blisters on chest. Y 05/10/1996 08/16/2001 1924 NONE PVT PVT PPD/Connaught NONE NONE 1
0174676 08/24/2001 CA 14.0 14 F 09/10/2001 Post vax, the pt lost consciousness and had rigidity of both upper and lower extremities, rolling up of eyeballs for a few minutes, pallor and sweating. Y Y 08/10/2001 08/10/2001 0 Blood sugar-98 PUB PUB NONE NONE NONE 1
0174677 08/24/2001 TX 12.0 12 F 08/08/2001 Father stated symptoms began on 3/2/01. 9 hours, post vax, pt complained of headache and flu symptoms, crying episode with distinct body odor. Symptoms continued X 1 month. Y 03/02/2001 03/02/2001 0 NONE PVT OTH Allergies to sulfa 1
0174678 08/24/2001 CA 15.0 15 F 08/16/2001 A 15 year old adolescent, developed back and side aches, 5 days, post vax. On the 6th day, she complained of painful deep breathing, sore throat, and a fever of 101F. Numerous complaints of fever, headache, leg aches, low energy, loss of appetite which lasted 5 days (8/11/01 to 8/16/01). Y 08/06/2001 08/11/2001 5 NONE PUB PUB NONE NONE NONE 1
0174679 08/24/2001 TX 11.0 10 F 08/07/2001 Mom stated that pt developed a rash to upper and lower torso. Rash appeared X 2 days. Y 07/05/2000 07/05/2000 0 NONE PVT OTH Had meningococcal meningitis 1/00. 1
0174680 08/24/2001 NE 1.5 1 .5 M 08/16/2001 Fever of 103F, some diarrhea and vomiting on 8/11/01. Rec'd baby shots on 8/6/01, so this is possible reaction to IPV or MMR. Y 08/06/2001 08/11/2001 5 PVT PVT NONE NONE Otitis Media 1
0174681 08/24/2001 MD 4.0 4 F 08/20/2001 Went to ER on 8/17/01 with facial swelling, hives, stridor and chest pain. Was given po steroids and had taken Benadryl at home. On 8/20/01, pt seen in office, fully resolved. Y Y 08/17/2001 08/17/2001 0 NONE PVT PVT NONE NONE NONE 1
0174682 08/24/2001 KS 3.0 3 M 08/10/2001 Presented 2 days, post vax, with fever, diarrhea and swelling to injection site. Y 08/08/2001 08/09/2001 1 NONE MIL MIL TB/PMC/C0521AA/ID/0 previously NONE NONE 1
0174683 08/24/2001 CA 4.0 4 F 08/14/2001 Left deltoid red and swollen. U 08/15/2001 08/16/2001 1 NONE PUB PUB PPD/C0832AA/LFA/1 previously NONE NONE 1
0174684 08/24/2001 WA 1.5 1 .5 F 08/15/2001 Mild fever for 2 days (8/13/01-8/14/01) that ranged from 102.3F to 99.0F. I gave her Motrin IB/Infants Formula at 02:00 on 8/13/01 to bring down the fever of 102.3F then fever went down to 100F. I gave her some more on 8/14/01. Y 08/03/2001 08/13/2001 10 PVT PVT NONE NONE NONE 1
0174685 08/24/2001 IN 5.0 5 M 08/11/2001 Pt developed a fine macular-papular erythematous rash on 8/6/01. Y 07/23/2001 08/06/2001 14 NONE PVT PUB NONE NONE 1
0174686 08/24/2001 PA 62.0 62 M 08/21/2001 Pt received Twinrix #1, 1cc, IM, in left deltoid and Typhium VI, 0.5cc, IM, in right deltoid at 09:20. He felt dizzy for several minutes after injections. Returned at 11:30 with complaints of bilateral buttocks and thigh achiness. Given Tylenol and told to rest. Symptoms resolved. At 21:30, went to ER with a temperature of 102F and feeling poorly. Evaluation done by doctor. Y Y 08/20/2001 08/20/2001 0 OTH OTH Robaxin and pain medicine with codeine for back spasm. NONE Allergic to Cleocin, sensitive GI to ASA, NSAIDS 1
0174687 08/24/2001 CO 2.0 2 .4 F 08/23/2001 Pt developed red and swollen reaction at site. Y U 08/21/2001 08/22/2001 1 PVT PVT 1
0174689 08/27/2001 MA 36.0 36 M 06/30/1998 Diffuse joint swelling began on 7/2/98. Pt with frank arthritis and joint swelling/effusion. Joint fluid sterile. Resolved with PT/NSAIDS. Hospitalized X 7 days. Still disabled but improving. Y Y 03/31/1998 04/10/1998 10 WBC; Joint fluid UNK UNK HIV (+); stable 1
0174692 08/27/2001 SC 4.0 4 M 03/15/2001 Initially very ill with high fever up to 103.4F (orally), chills with increased sinusitis and chest congestion. Seemed to recover in 5-6 days. Shortly thereafter, he started demonstrating "ticks" with hands, eye, mouth, arms and legs. He also lost ability to read sight words that he had done previously. He became hyper, had short attention and was unable to learn to read. Child was 4 years old when vaccines were given. On 8/17/01, report filed 3 1/2 years after child was given multiple vaccines of the routine childhood schedule at age of 4. Pt had fever and possible URI symptoms following that evening. After an unknown period, the pt developed neurologic symptoms and lost developmental milestones. No medical evaluation of the child since that time was provided with report, therefore I do not have a dx of the current status. The family reports autism. While vaccines have been suggested as a cause, studies have revealed the majority of cases of autism are not likely due to vaccines. The cause of the autism is currently unknown. 60 day follow up on 11/04/2003: "Vaccine recipient recovered from the adverse events." Y U 12/11/1997 12/11/1997 0 NONE PUB PVT Runny nose milk allergy SC0110 1
0174693 08/27/2001 NM 4.0 4 M 08/20/2001 On 8/15/01, pt developed redness, swelling and a itchy rash at site of injection of vaccines that were given on 8/14/01 on right anterior-lateral thigh. Seen in office on 8/16/01 and advised to apply ice to site and use ibuprofen for pain and inflammation. Y 08/14/2001 08/15/2001 1 PVT PUB NONE NONE 1
0174694 08/27/2001 TN 2.0 2 .0 M 08/20/2001 Pt developed fever of 102.5F. Went to ER. Vomited X1 about 15:00. Site of injection tender to touch and inconsolable until about 17:30. Dx'd with vaccine reaction at ER. Y Y 08/16/2001 08/16/2001 0 PVT PVT Phenobarbital 30mg Q D NONE V-P shunt, Pulmonic stenosis, seizures 1
0174695 08/27/2001 IL 3.0 3 F 08/16/2001 Y 08/11/2001 08/13/2001 2 OTH OTH NONE 1
0174696 08/27/2001 CA 1.0 1 .0 M 08/21/2001 Pt's mother called on 8/10/01 and said pt had developed a lump at Comvax or varicella injection site. On 8/11/01, pt developed raised lump at varicella injection site with "bumps". On 8/21/01, pt came in for office visit and has what appears to be chickenpox only at varicella injection site in less than a 1" circle. He denies fever or any other symptoms. Y 08/09/2001 08/10/2001 1 PVT PUB NONE NONE 1
0174697 08/27/2001 NC 1.0 1 .0 F 08/15/2001 Approx 1 week and 2 days ago, pt was here for vaccinations and was discharged home. Today she comes in with complaints of swelling in left leg which had increased in size, in the past 2 days, from pea-sized to 3 1/2cm X 2cm. The area was very red and irritated but otherwise, no adverse signs and symptoms. Y Y 08/06/2001 08/13/2001 7 PVT OTH NONE NONE NONE NC01074 1
0174698 08/27/2001 UT 0.3 0 .3 M 08/15/2001 At 15:00, on 8/8/01, pt woke up choking, difficulty breathing, limp and pale. This lasted approx. 40 minutes, then baby had a crying episode that lasted 45 minutes and unable to comfort baby by feeding or holding. Tylenol was given at 16:00. Y Y 08/07/2001 08/08/2001 1 NONE PVT PVT NONE NONE NONE UT012512 1
0174699 08/27/2001 UT 1.0 1 .0 M 08/10/2001 On 8/8/01, at 08:00, pt woke with swelling of glands on left side of face and neck. Child felt warm to touch and mother gave him Tylenol at 09:30. Office visit at pediatrician's and was Rx'd Cephalexin. On 8/9/01, at 11:00, the baby awoke crying with both sides of face swollen. Taken to ER and temperature was 98.8F. Rx'd Tylenol with codeine and dx'd with parotitis. Y U 07/16/2001 08/08/2001 23 On 8/8/01; CBC; Lead screening PUB PUB Tylenol Mother stated "teething" NONE UT012510 1
0174700 08/27/2001 TN 0.7 0 .7 M 08/23/2001 Pt developed a persistent temperature to 102F X 5 days. No treatment except ibuprofen and Tylenol. Y 11/27/2000 11/27/2000 0 PVT PVT NONE Pulmonic stenosis (mild) 1
0174701 08/27/2001 GA 0 .0 F 01/21/1998 Post vax, the patient's face became bright red. The patient was crying and within seconds her face became blotchy. While being examined, small pinpoint raised spots appeared with large irregular splotches and raised bumps. The rash spread all over the patient's entire body within 5-8 minutes. Circumoral cyanosis was noted. U 01/18/1998 01/18/1998 0 UNK UNK 1
0174702 08/27/2001 OR 24.0 24 F 07/25/2001 On 07/24/2001 the site of the injection was sore. On 07/25/2001 the patient's arm at the site of the injection was sore, red swollen and hot to the touch. Y U 07/23/2001 07/24/2001 1 PUB OTH NONE NONE NONE OR200129 1
0174703 08/27/2001 VA U Six years ago the patient received an influenza virus vaccine 1987-88 formula (manufacturer unknown) and developed a reaction at the injection site described as "ulceration". On follow up, the physician noted that he did not know the patient, nor was he aware of any such reaction in his patient population. U UNK OTH OTH UNK UNK UNK 8932790115 1
0174704 08/27/2001 NC 52.0 F 12/27/2000 The patient reported that she received an injection of 1997-1998 formula influenza virus vaccine (manufacturer unknown) in 1997 and subsequently developed shingles. The patient recovered. Y UNK OTH OTH UNK UNK UNK Bell's Palsy~Influenza (Seasonal) (FluShield)~~54.00~In Patient HQ5045119DEC2000 1
0174705 08/27/2001 MD 29.0 29 F 06/18/2001 Post vax, the patient developed raised pustules scattered on her chest, back, legs, arms and face. The patient experienced bilateral swollen neck glands. Y U 06/12/2001 06/15/2001 3 PUB PUB NONE NONE NONE MD01005 1
0174706 08/27/2001 MN 50.0 50 F 01/25/2001 Post vax, the patient developed upper arm swelling, erythema above the elbow, chills, sweats, deep muscle ache, and itching. No fever was noted but the patient feels feverish and flushed. U 01/09/2001 01/09/2001 0 NONE PVT PVT ASA NONE NONE 1
0174707 08/27/2001 MO 4.0 4 M Post vax, the patient developed a large 8 x 10cm area of redness, firmness and warmth on the lateral thigh. Y 08/08/2001 08/09/2001 1 NONE PVT PVT AR0134 1
0174708 08/27/2001 MN 1.08 1 .1 M 07/30/2001 Seven days post vax, the patient developed a fever of 103F and a prominent rash that looked like measles. The rash went away after 6 days. It was itchy and uncomfortable. The patient was treated with Motrin. Y 07/02/2001 07/09/2001 7 PVT PVT Zithromax Ear Infection 1
0174709 08/27/2001 KY 10.0 10 F The patient experienced generalized urticaria starting 12 hours after vaccination. U 08/20/2001 08/20/2001 0 UNK UNK NONE 1
0174710 08/27/2001 GA 18.0 M 08/21/2001 Post vax, the patient experienced nausea and "feels bad". U 08/14/2001 08/21/2001 7 NONE UNK UNK NONE 1
0174711 08/27/2001 GA 33 F 06/25/1999 Post vax, the patient experienced a fever of 103F and chills. The patient had no other symptoms. Y 06/07/1999 06/08/1999 1 UNK UNK NONE 1
0174712 08/27/2001 UT 5.0 5 M 08/13/2001 This child had an induration, redness 18 x 13cm. U 08/08/2001 08/09/2001 1 NONE PVT UNK NONE NONE UT012511 1
0174715 08/28/2001 KY 0.3 0 .4 M 08/22/2001 SIDS Y 07/18/2001 N 07/12/2001 07/18/2001 6 PUB UNK NONE NONE 1
0174718 08/28/2001 CO 1.0 1 .6 M This correspondence is to document the circumstances regarding this infant's recent adverse reaction to the Haemophilus influenzae type B (Hib) vaccination. The infant has been followed up by a doctor since the 1st year of life for anaphylaxis to cow's milk. Skin test reactivity was noted to peanut and egg protein at the time of initial evaluation and thus, these foods have been avoided. By current AAP Redbook recommendations, precautions with MMR are not necessary but at the pediatrician's request special precaution with MMR was undertaken. The infant received this vaccination as 0.1 ml into the right thigh followed by 0.4 ml into the left thigh with two localized urticarial lesions noted on the left thigh in the area the MMR was administered. He was treated uneventfully with Benadryl at that time, and the urticaria resolved within 10 minutes. Other vaccinations including DTaP and Varivax were administered on 10/09/99, again, uneventfully. The infant has received the Haemophilus influenzae type B (Hib) previously without adverse reaction. On 03/30/00, Haemophilus influenzae type B (Hib) was administered as ProHIBit, the Haemophilus influenzae type B - diphtheria toxoid conjugate vaccine. He was observed for 20 minutes in your office and was discharged home after a seeming uneventful vaccination. The infant began to develop urticaria within 15 minutes followed by cough and rhinorrhea. He was treated with Benadryl and the doctors office was called. The infant was reported to have increased cough and worsening symptoms and, thus, the infant's mother was advised to administer Epi-Pen Jr and call 911. Upon arrival in the ER, the infant was noted to have significant urticaria, but no angioedema or signs of respiratory distress. The upper airway was clear and the chest was clear to auscultation. The infant was treated with Prednisone, Zantac, another dose of Benadryl, and another dose of epinephrine. The treating physician in the ER regarded the infant's anaphylactic reaction as "mild" and the infant was observed until the event resolved. A review of the package insert for ProHIBit reveals that this is a Haemophilus influenzae type B polysaccharide covalently bound to diphtheria toxoid protein with thimerosal added as a preservative. It is unclear which component of the vaccine is responsible for the anaphylactic reaction, but thimerosal has been implicated in other adverse reactions to vaccines. The physician's recommendations are: 1- Avoid thimerosal containing vaccines and eyedrops. Further assessment of thimerosal allergy will be undertaken if they can obtain some thimerosal for this purpose. 2-No further vaccination with ProHIBit should be offered. The infant will be due for repeat Haemophilus influenzae type B vaccination at five. A HIB titer may be obtained at that age to assess his immunity and if the titer is protective, repeat vaccination can be avoided. 3-The infant should receive diphtheria and tetanus boosters DT) at appropriate ages. However, precautions should be undertaken with these vaccinations and should best be administered in the allergist's office. 4-Caution administration of all future vaccinations is advised. Theses may best be administered in the office of an allergist and administered in an incremental fashion. The infant should be observed for one hour after each future vaccination. Y Y Y 03/30/2000 03/30/2000 0 UNK UNK 1
0174719 08/28/2001 CA 38.0 38 F 08/15/2001 Vaccine DT given to left deltoid on 7/24/01 at 13:30 and felt light-headed. She went to eat. At 16:30 she had a seizure Grand Mal and went by EMS to the ER. Her temperature was 100.2F. In the hospital, over the next 4 days, she had 7 seizures, was lethargic, decreased appetite, and weight loss. She had localized swelling, redness, a lump and site was hot to touch. Still sleepy with decreased appetite and don't feel well. She was given IV fluids. She had DT Pediatric instead of Adult TD. Y Y Y 6 U 07/24/2001 07/24/2001 0 MRI; CT; EEG; Labs PUB OTH PPD/Mantoux/SC/RFA/2 previously; Topamax; Paxil; Iron; Multivitamins; Neurontin (pain) NONE Fibromyalgia, chronic fatigue, anemia 1
0174720 08/28/2001 PA 0.5 0 .6 F 08/13/2001 On 02/20/01, I took the patient to the hospital for a temperature of 103.1. She was showing signs and symptoms of the flu. At this time the flu was really going around. We were at the hospital for approximately five hours. Around the fourth hour, they attempted to take blood, having stuck the needle in both arms moving it up and down and all around; both arms were turning purple from all of their sticking. I told them to forget trying to draw blood because of the fuss the patient was making. She hadn't eaten since we got there, and she was tired. So I told them if she got any worse I would bring her back. They wanted to draw the blood to check and make sure her flu symptoms were just that, and not an infection. They told me just to give her children's Tylenol. So in the three weeks that followed she went through probably three or four bottles of children's Tylenol cold formula. During this same three weeks I got up one morning to find my daughter standing in her bed, with a "lump" on her head. The only way I know to describe the lump is it looked like a "soft golf ball" right between her eyes. When I touched it she showed no sign of pain or discomfort. The lump was not bruised or discolored I assumed maybe that she bumped her head. I took digital photos of her and sent them to my mom and one other. Both replied immediately saying she didn't look like she felt to well, other than that she looked fine. She had a couple spells of "shaking" in these three weeks also. It to me looked like seizure like episodes. One night she fell asleep in her playpen and I picked her up to carry her to her crib. She was shaking as I carried her. To me it did not seem like she was cold, at least not to the touch. So I attempted to wake her to make sure she was ok. She would not wake up. Normally if you sit her down in front of you and say her name she wake right up. This night should not wake up. I said her name, I tried to tickle her, I tried to rustle her around, and nothing was working. So person said her name aloud and she awoke. She seemed fine, and fell back asleep in my arms. So I carried her to her bed. The following day, she slept literally all day. Around noon or one in the afternoon I called the hospital and informed them of her symptoms and asked if they thought she needed to come in. They blew me off. I think the lady was in a hurry to get off the phone. So I called my mom, and person's mom, they both reassured me that the flu was going around and not to worry. On Saturday, 03/03/01, I had my daughter 1st birthday party at our house. Person's family came up, and my family came down. My stepmother who is a RN said she noticed my daughter having these "staring" spells. She said they are termed medically as Petite Grand Mal Seizures. She didn't seem to have any fun. She did not act like a vibrant one year old. On Sunday, 03/04/01, it was my 1st day to work. My scheduled shift was 6pm-3am. I was getting ready to leave at 5:30 pm and my daughter was fussy and seemed tired so I laid her down for a nap. Person says he woke her between 9:50pm and 10:00pm. He says she was burning up with fever. He says she had vomited her dinner, had a dirty diaper, and was also soaked with sweat. So he wanted to put her in the bathtub and clean her up. He stripped her down and took her to the bathtub. He set her in the empty tub and turned the shower on. Cold water sprayed on her. So person turned it off immediately until it was warm. He then bathed her in warm water. He washed her hair holding her head and neck in his hands, then her body. He says it was only about a ten minute bath. He removed her and wrapped her in a towel. I came up the stairs approximately 10:10pm, on my lunch break. When I walked up the stairs he had her wrapped in a towel holding her close to his chest. Her arms and legs were extended, and she was moaning. I asked him to give her to me. When he turned her around to me, I was floored by how sick she looked. Her eyes were sort of rolling, she was not responding to me. She was awake, just not focusing on anything. I took her directly to my bed and wrapped our comforter around her she was literally freezing. Her feet were a shade of purple and part of one of her arms. I said her name a few times and when she still did not look at me I said were taking this baby to the ER. So I got her dressed really warm and we headed off to the hospital. It is now approx 10:30pm. When we walk thru the door at the ER, I am now frantic wanting to know what is wrong with her. They take her in immediately. She had a temperature of 84 degrees and required, artificial warming, a ventilator, along with intravenous fluids and medications to maintain her blood pressure. They also told me they gave her a "heavy" dose of seizure medication; she appeared to be having one when we brought her in, and also because I described seizure like activity. So the doctor called a hospital and asked for life flight team to come and transport her to their hospital. But because of the snow she had to go by ambulance. They stabilized her and did not transport her to the hospital until approx 2-3 am. There she was taken to peds ICU and was listed in critical condition. She had CT scan and and EEG. They did blood cultures, which all came back negative, although they said it still sounded like a viral infection. And other testing I'm sure. She remained in peds ICU until approx 8 or 9 pm Monday, 03/05/01. In the week that followed she underwent more EEG's, a MRI, and more Blood cultures, and full body x-ray. All of the EEG's were normal, so the thought of being epileptic was ruled out. I was told that sometimes when children get sick and especially with the type of viral infection they suspected she had sometimes they have seizures. They said once the infection was treated and gone, she should not have any more seizure activity. We were in the hospital until 03/11/01. During her stay in the hospital she seemed to be feeling much better. For the 1st time in three weeks her congestion was gone, her nose was no longer running, no more sneezing, and her cough was gone. She still didn't want to eat very much though. She lost three pounds during her week stay. So on the 11th we were released, being told when I originally took her to the 1st hospital she was having a febrile seizure, she had a viral infection, and had acquired anemia. They gave me a prescription for an antibiotic for the infection and and iron supplement for the anemia. After we left the hospital she seemed to be feeling much better. In the weeks that followed she played and ate a little better. She was finally acting like a one year old should act. On Tuesday, 04/17/01, my daughter and I met person at 3:00pm to ride over to the community college to turn in some paper work of mine. We all went in and I turned in the paper work and scheduled testing. We left from there and rode around to look at real estate. It was starting to get dark, and my daughter started getting fussy so we stopped at the store to get a few things real quick. We went in got what we needed and went home. It was dark by the time we got home. I fed my daughter and changed her diaper. Person and I played with her for a little bit then we took her to bed. I laid her down, and gave her a kiss, while person closed her curtains. I turned on her monitor, we told her we loved her and shut the door. The following morning Wednesday, 04/18/01, person and I got up at approx 5 am I fixed him breakfast while he got ready for work. He went on to work at approx 5:45am and I layed back down. At approx 5 minutes after 8am, I heard her 1st cry. Then approx 8:20 am I heard her cry again. Only this cry seemed like a painful cry. I jumped up and ran right in and found her lying in her bed rather than standing. Which was very strange. She is always standing to greet me. So I was wondering immediately what was wrong. I thought maybe she was still tired and possibly didn't feel well. I picked her up and carried her down the stairs. When we got down stairs we did the morning ritual. I changed her diaper, put her her in her little rocking chair, turned Barney on, and gave her some milk. During all of this she was fussy. I went in to make her breakfast. I made her oatmeal, and brought it into the living room to feed her. When I put her in her high chair she didn't want to sit there, nor did she want to eat. So I placed her on my lap and cuddled. About half way through Barney she turned her head away from the TV and wanted me to hold her, while she cried. At approx 10:20am I called my mom in WV concerned for the way she was acting. My mom could hear her in the back round crying, so she told me to give her ten minutes to get dressed and she would be there. It takes her about an hour and a half to get to my house. So I knew it would be about noon when I would see her. I hung up the phone and called person at work. I told him my daughter seemed like she didn't feel well and that my mom was coming to see. I told him I was going to call the doctor and see if he could see her. We hung up and I called he pediatrician. His nurse told me it was his early day and he would be leaving at approx 11:30am. She asked if I could get my daughter there before that and I told her no, my mom wasn't going to be at my house until noon or after. So we agreed if my daughter got any worse I would take her to the hospital. My mom and stepfather got there right about noon. When they got there I went up to take a shower. When I came down from the shower my stepfather had observed her behavior and thought something was wrong with her leg. He said when he straddled her across his lap to play paddy-cake she would cry. So I layed her down on the floor and began playing with each leg. First the right nothing, Then the left and she showed discomfort. I assumed from all the walking we had been doing with her maybe she twisted her ankle. My mom stayed until about 6:00pm. She told me to keep an eye on her leg and foot, and if there was ever any bruising or swelling to take her to the hospital. So I monitored it all evening. She seemed fine. The following morning, Thursday, 04/19/01, she was standing in her bed like normal. We did all the same morning rituals. She ate and played and seemed fine. The same for the following day also. On Saturday, 04/21/01, we had an appointment to look at some real estate. While we were outside looking at the garage, I attempted to put my daughter down to stand on her own. She fussed when I did this. She was favoring her left leg. I took her to the truck and pilled her pant legs up and noticed the left leg becoming slightly swollen. I called person over to the truck and he took a look. I told him I was calling the doctor first thing Monday and taking her in. The next day, Sunday, 04/22/01, she stood on it a little better, but still I was going to take her. So on Monday, 04/23/01, at approx 9:00am I called the doctors office to see when he could see her. I was told to bring her in at 11:15am. He took a look at her and when he pressed on the bone on the left leg, she showed signs of pain and discomfort. He told me he thought her bone was fractured and to take her to the hospital immediately. So I swung by my house and got person and we were off for the hospital. When we got there they did x-rays of her leg and found a spiral fracture. They put a cast on up her thigh and said it would come off in about a month. The orthopedic doctor said that there was no way she could have this type of fracture in her bed. Which was my only theory. When I put her to bed on the 17th she was fine and when I went in on the 18th she was not standing. Since then the cast has been removed. They say her leg has healed perfectly after only three weeks. She has been placed on high calorie / high protein diet to help her gain weight. She has gain about 4 to 4 1/2 pounds. Y Y Y 6 Y 09/26/2000 02/10/2001 137 CT; EEG; Blood cultures and a full body X-ray-All WNL PVT UNK 1
0174721 08/28/2001 CA 0.3 0 .3 M 08/23/2001 Pt became cyanotic and floppy. Per doc 204152, 60 day follow up, patient has been diagnosed with diffuse cutaneous mastocytosis. Either of the vaccines may have caused mastocyte release, with subsequent drop in blood pressure and cyanosis. Y N 08/20/2001 08/21/2001 1 EEG-nml; MRI-nml; CXR-nml; Labs (CBC, Electrolytes, Bun, CR, LFT's, etc)-all nml. PVT PVT NONE NONE NONE 1
0174722 08/28/2001 HI 1.5 1 .5 F 08/16/2001 One day post vaccination the injection site was erythemtous and indurated. Pt a little fussy. On exam an8X9 area of induration and erythema. Site was non tender. No drainage. No fever. Treated symptomatically. Y U 08/15/2001 08/16/2001 1 NONE PVT PUB Amoxicillin Acute sinusitis vs acute nasopharyngitis NONE 1
0174723 08/28/2001 MI 1.3 1 .3 M Pt developed hives. Y Y 08/09/2001 08/14/2001 5 PVT PUB Dimetapp, Motrin NONE NONE 1
0174724 08/28/2001 MI 2.0 2 .1 F 08/16/2001 On 8/16 mother called and said daughter's right leg was swollen the size of a softball, warm and had red streaks. Mom had given warm baths, 2 today and Tylenol. Bled after 2nd bath, told to call Dr due to size of reaction and red streaks. Pt saw Dr regarding reaction. He did not feel it was cellulitis, but a significant reaction to the immunization. By 8/21 the reaction had gone down some, but still had a hard lump. Told client that tetanus can cause a lump that may last for days or weeks, but will gradually absorb. Recommended she talk with Dr prior to school shots. Y Y 08/14/2001 08/16/2001 2 NONE PUB PUB Floxin ear drops NONE NONE 1
0174725 08/28/2001 IL 6.0 6 M 08/10/2001 Pt became pale and limp, eyes glazed and rolled upward slightly. This happened after injection of Prevnar. Lasted only a few seconds. Called 911 fire dept responded 1st. Ambulance came. Mother refused transport to hospital Y 08/10/2001 08/10/2001 0 UNK OTH PUB NONE NONE IL01028 1
0174726 08/28/2001 NJ 1.5 1 .0 M 07/25/2001 Pt had a high fever 4-5 hours post vaccination, as well as a rash all over his body and edema in hands and feet. Y 07/23/2001 07/23/2001 0 CBC, SMA7 all normal PUB OTH NONE NONE Penicillin allergy. NJ200113 1
0174727 08/28/2001 NJ 1.2 1 .2 M 07/27/2001 Noticed to have urticarial rash right upper leg and flushed area on arms and legs. He had induration at injection site area. Received 5 mg of Benadryl CM with some improvement. Y U 07/26/2001 07/27/2001 1 OTH OTH NONE NJ200115 1
0174728 08/28/2001 NJ 1.4 1 .4 F 07/24/2001 On 7/26/01 at 6 AM pt had fever of 104 F. On 7/27/01 at 2 PM fever was 104.4 with Advil and Tylenol. Pt went to Dr and the diagnosis was viral syndrome. Y U 06/22/2001 07/26/2001 34 Throat culture negative for strep PUB PUB NONE NJ200114 1
0174729 08/28/2001 AL 2.0 2 .9 F 08/23/2001 Large red area on left thigh and warm to touch. Y 08/22/2001 08/23/2001 1 PVT PUB NONE Pt has CF 1
0174730 08/28/2001 CA 1.6 1 .6 M 08/23/2001 Vaccination reaction with pain, swelling to left thigh. 110 mm X 86 mm area with erythmatous, edema, and tender. Y Y 08/21/2001 08/22/2001 1 PVT PVT NONE NONE NONE 1
0174731 08/28/2001 TX 36.0 36 F 08/23/2001 Pt had double vision, dizziness, for 5 months and still on and off. Occurs on her right now. She went to see family Dr and neurologist, but they did not find out any diagnosis for her. Y N 03/27/2001 03/29/2001 2 MRI PUB PUB NONE NONE NONE 1
0174732 08/28/2001 20.0 20 F 08/17/2001 Pt complained of difficulty breathing, generalized hives, mild SOB, Rsp-24, facial swelling, redness, hives, decreased lung bases. Upper arms, trunk and thighs with wheals erythmatous. Mild anaphylaxis. Epigen and epinephrine, Benadryl given and transported to hospital and monitored for 6 hours. Y Y 08/15/2001 08/15/2001 0 MIL MIL NONE NONE NONE 1
0174733 08/28/2001 NC 1.08 1 .1 F 08/14/2001 10 days following this infant's shot, she had a mild rash on her chest, back and neck; fever- not monitored, sleeplessness, and irritability lasting 2 days. Y 07/10/2001 07/20/2001 10 NONE PVT PUB NONE NONE NONE NC01072 1
0174734 08/28/2001 VA 11.0 10 F 08/20/2001 This child was feeling tired, run down, no energy. Had sore throat, indigestion, tingling in her arms, blurred vision, nausea, constant abdominal pain, anorexia, esophageal reflux, Episodes of (ongoing) gas. Hair loss, quarter size swollen cervical lymph nodes, bumps on her scalp leaving multiple bald spots with 3 inch circle in the crown of her head, still warm to touch. Still has to see the MD. Ongoing visits to the doctor as of 08/20/01. Y N 01/17/2001 03/21/2001 63 Tested for Mono, fungal infection of the scalp, strep, abdominal ultrasound done 08/10/01. PUB OTH History of asthma. ~Hep B (no brand name)~2~8.00~In Sibling 1
0174735 08/28/2001 MN 1.08 1 .0 F 08/22/2001 This infant was immunized 08/08/01. She had a rash on her face, body, extreme started 08/18/01. Blisters on her buttock on 08/17/01, and the next day head to toe pruritic rash. U 08/08/2001 08/17/2001 9 PVT PVT NONE NONE NONE 1
0174736 08/28/2001 LA 7.0 7 M 08/22/2001 This child had a rash on his torso, arms, legs, neck, and face. Raised areas of various sizes up to 1 1/2 cm diameter. U 08/17/2001 08/18/2001 1 PUB PVT 0 NONE NONE 1
0174737 08/28/2001 LA 4.0 4 F 08/23/2001 On 08/23/01 this patient had elevated pink area on the back of left at the site of MMR, diameter 1 1/2 inch. Y 08/21/2001 08/22/2001 1 PUB PVT PPD, Connaught, Lot # C0153AA, Intradermal, left forearm, 1 previous dose. NONE NONE 1
0174738 08/28/2001 TN 1.6 1 .6 F 08/18/2001 This infant had redness at the injection site on the day of the shot (08/16/01). Redness (9 1/2 x 9 1/2 cm) and swollen (5 1/2 x 5 1/2 cm) on 08/17/01. Told to give Tylenol, Benadryl, and Augmentin. Y Y 08/16/2001 08/17/2001 1 PVT PVT Probable allergic rhinitis. 1
0174739 08/28/2001 WI 1.0 1 .0 F 08/19/2001 This infant had a fine rash to her legs with a few spots developing in the afternoon to the abdomen. Y 08/19/2001 08/19/2001 0 PUB PUB NONE NONE 1
0174740 08/28/2001 NC 24.0 24 F 08/17/2001 5 minutes after this patient had Hepatitis B vaccine administered she complained of feeling faint, tightness in throat area, pain in the neck and abdomen. BP decreased 77/50, 0.3 epinephrine administered, symptoms subsided. BP increased 110/60. The patient was monitored by staff and released at 12:30 pm with normal vital signs. Y 08/15/2001 08/15/2001 0 NONE PVT PVT NONE NONE Symptoms similar to the above symptoms.~DT Adsorbed (no brand name)~~19.00~In Patient 1
0174741 08/28/2001 WI 14.0 15 M 08/21/2001 TD shot on 08/17/01 on the 3rd day post vaccination this patient developed a rash on his trunk, palms, soles, arms and legs, afebrile. Y U 08/17/2001 08/20/2001 3 PVT OTH NONE NONE NONE 1
0174742 08/28/2001 CA 1.0 1 .1 F 07/01/2001 This patient was listless, irritable, and unlike herself for two weeks following shots. She was unable to walk for 2 days and had trouble walking for the 2 weeks following shots. Y 05/11/2001 05/11/2001 0 PVT UNK NONE NONE NONE 1
0174743 08/28/2001 IL 5.0 5 F 08/20/2001 30 minutes after Varivax injection, this child developed urticaria, edema lips and eyelids, and skin itching. Improved after Epinephrine given. Y 08/15/2001 08/15/2001 0 NONE PVT PUB NONE Allergic rhinitis Asthma, allergic rhinitis, Penicillin allergy. 1
0174744 08/28/2001 MN 18.0 18 F 08/09/2001 This patient had a fever of 104 - 102 over the course of one week. Also having headache and stiff neck first 2-3 days. On day 9 diagnosed with Right otitis media. Y U 08/01/2001 08/01/2001 0 U/A, CBC - WNL PVT PVT NONE NONE 1
0174745 08/28/2001 OK 37.0 37 F 08/20/2001 This patient had 4 cm erythematous lesion with nodule. Allergy vs cellulitis (warm, erythema) being treated with antibiotic and 18 hour follow up. Y U 08/13/2001 08/13/2001 0 MIL MIL NONE NONE 1
0174746 08/28/2001 LA 23.0 23 F 08/20/2001 3 days after 2nd Hepatitis B injection, this patient developed itching rash, to the lower abdomen only. Had same amount of itching after injection. Injection site without rash. Y 08/10/2001 08/10/2001 0 NONE PUB PUB Zithromax, Cefixtone. Gonorrhea NONE 1
0174747 08/28/2001 MS 4.0 4 M 08/22/2001 Erythema on left upper arm with centrally located vesicles approx 4-5cm in diameter. Rx'd Benadryl Elixir 1/2 tsp every 6 hours; Hydrocortisone cream 1% bid and Amoxicillin 250mg tid X 10 days. Y Y 08/13/2001 08/14/2001 1 PUB PUB NONE NONE NONE MS01036 1
0174748 08/28/2001 KS 5.0 5 F 08/20/2001 Swelling and redness locally at left thigh injection site about 5cm in diameter on 8/9/01. Y Y 08/08/2001 08/09/2001 1 PVT PVT NONE NONE NONE 1
0174749 08/28/2001 MA 1.7 1 .7 U Pt cried all night; would not settle down in crib but did settle briefly in parent's arms. Y 08/21/2001 08/21/2001 0 PVT PUB URI NONE 1
0174750 08/28/2001 IN 0.5 0 .5 M 08/14/2001 Pt developed a high fever of 103.3F. Had shots about 13:30 and vomiting came around 17:30. He was very cranky, body was very hot and would not hold food down. Used Pedialyte and on doctor call, a suppository was used. Family doctor was advised and he called in a suppository. Had a fever with the 2nd set of series of shots. Y Y 08/06/2001 08/06/2001 0 NONE PUB PUB NONE NONE 1
0174751 08/28/2001 AR 5.0 5 M 08/17/2001 Approx. 3 hours, post vax, child felt hot, face was puffy and had nasal congestion. Y 08/15/2001 08/15/2001 0 PVT PVT Dallergy NONE Chronic allergies 1
0174752 08/28/2001 MO 4.0 4 F 07/31/2001 Pt developed probable herpes zoster dermatitis, T12-L1 on left about 2-3 days after vaccine. Under treatment on 7/31/01. Y Y 07/24/2001 07/26/2001 2 NONE PUB PUB NONE NONE NONE MO2001043 1
0174753 08/28/2001 FL 41.0 41 M 05/15/2001 Increased erythema, pain and swelling. Treated with Clindamycin. U 05/12/2001 05/14/2001 2 OTH OTH NONE NONE 1
0174754 08/28/2001 FL 33.0 33 F 05/14/2001 Pt developed mild erythema on left shoulder with warmth. Treated with Clindamycin 150mg #28 1 QID. Y 05/08/2001 PVT PVT 1
0174756 08/28/2001 FL 48.0 48 M 07/11/2001 Pt developed right deltoid pain, post vax. Also had induration and redness at site. Y 07/09/2001 PVT UNK Laceration 1
0174757 08/28/2001 MO 2.0 2 .2 M 08/24/2001 On 8/1/01, varicella shot given and on 8/5/01, pt started having diarrhea, lasting 2 days. On 8/15/01, pt's thigh was red and hot. On 8/22/01, pt had a bite-like rash over body (approx. 10-15 spots). Bites had hard knots with red halo, no pustules. No treatment needed. Rash if fading. U 08/01/2001 08/05/2001 4 NONE PUB UNK NONE NONE NONE 1
0174758 08/28/2001 MI 10.0 10 F 08/13/2001 Mother states, post vax, the pt got into the car and suddenly stated "I feel dizzy" or "wheezy". Mom asked if she was ok and the pt's eyes were droopy and she did not respond and slumped forward. Mom ran around to the other side of the care and pt sat up, stiffened upper torso and extremities and face and eyes were red, like she was holding her breath. Her eyes were wide open and she was gripping the seat belt with her hands. This episode lasting about 1-3 minutes, then when pt awakened, states she was OK, "I just fell asleep". Y Y 08/13/2001 08/13/2001 0 CT Scan of head on 8/13/01 PUB PUB NONE NONE Surgery for pyloric stenosis at 5 weeks old with no problems since. MI2001058 1
0174759 08/28/2001 CA 2.0 2 .1 M 08/17/2001 Pt developed erythema multiforme (minor) and is recovering. U 08/08/2001 08/09/2001 1 NONE PVT PUB NONE Drug reaction possibly; atopic dermatitis (mild) 1
0174760 08/28/2001 CA 0.6 0 .5 M 08/17/2001 Undiagnosed rash (symmetric and discrete) 0.25-2cm papules of a total of about 20 on outer arms, outer thigh and face. Resolved about 3-4 days and the dermatologist is not calling it an allergic reaction. Y 07/09/2001 07/10/2001 1 PVT PVT NONE NONE 1
0174761 08/28/2001 CA 2.0 2 .6 M 08/17/2001 This child had a fever of 105 on day 5 after vaccine, both associated with respiratory illness / concomitant clinical diagnosis pneumonia day 5. Y 07/18/2001 07/23/2001 5 NONE PVT PVT NONE NONE Mild RAD (diagnosed after 1st vaccine). 1
0174762 08/28/2001 AL 2.0 2 .8 F 08/22/2001 This infant had urticaria, Benadryl was given. Y Y 08/21/2001 08/22/2001 1 NONE PVT PVT NONE NONE NONE 1
0174763 08/28/2001 OH 4.0 4 F 08/21/2001 This child was given DTaP in the left deltoid on 08/17/01, pain, swelling, redness and warmth, hard 08/20/2001. Treatment : supportive care. Y 08/17/2001 08/20/2001 3 UNK UNK 1
0174764 08/28/2001 UT 5.0 5 F 08/22/2001 Immediate injection reaction of 10cm X 15cm area of heat and swelling to SC administration. No chest or pulmonary complaints. (Urticarial redness and swelling). Y 08/21/2001 08/21/2001 0 NONE PVT OTH NONE NONE 1
0174765 08/28/2001 KY 4.0 4 M Pt received 3rd IPV vaccine and had a local reaction. Y 08/21/2001 08/22/2001 1 NONE PUB PUB NONE NONE NONE 1
0174766 08/28/2001 FL M A male pt reported that he received a dose of Adenovirus Vaccine Live Oral Type 4, Adenovirus Vaccine Live Oral Type 7, Poliomyelitis virus and Influenza Bivalent vaccines on 2/4/75 when he was in the military. The pt noted that his medical records indicate that a "couple of days" after vaccination, he developed "nose bleeding and neck adenopathy". He also reported that he has been dx'd with chronic Hepatitis C. The reporter indicated that "his neck is swollen to this day". Additional information received on 7/11/00 included the pt's medical records which indicated that the pt had recurrent nose bleeds from his right nostril, his throat was inflammed and had neck adenopathy. U 02/04/1975 UNK MIL MIL UNK UNK UNK HQ8156805JUL2000 1
0174767 08/28/2001 PA 25.0 24 F 01/16/2001 A nurse reported that a female, now 33 years of age, received an injection of 1992-1993 formula influenza virus vaccine in 1992 and subsequently, developed the flu. She recovered after 2 days. (This pt developed a swollen tongue, a painful knot in her neck, numb lips, pallor and felt strange following a recent receipt of Flu Shield 2000-2001 formula; see MCN HQ5928515JAN2001). Y 01/01/1992 UNK OTH OTH UNK UNK UNK HQ5940615JAN2001 1
0174768 08/28/2001 OH 46.0 45 F 10/02/2000 A female, now 54 years of age with a history of allergy to eggs since childhood, reported that she received an injection of 1992-1993 formula influenza virus vaccine in 1992 and subsequently, developed a fever of 104F and generalized hives. She also developed an injection site reaction characterized by "severe" swelling and redness. She was seen by the physician and treated with an injection of an unidentified medication. She recovered. Y Y 01/01/1992 01/01/1992 0 UNK OTH OTH UNK UNK Food allergy HQ9125328JUL2000 1
0174769 08/28/2001 VA 52.0 51 F 08/23/2000 A 52 year old female reported that she received 1994-1995 formula influenza virus vaccine and subsequently, developed a local reaction. She reported that it was felt that the reaction may have been "related to the eggs". U 01/01/1994 01/01/1994 0 UNK OTH OTH UNK UNK Hypersensitivity NOS HQ9960217AUG2000 1
0174770 08/28/2001 LA 41.0 40 F 08/15/2001 Pt reports about 30 minutes, post vax, she began to feel weak and nauseated. She was training in a nursing home and her BP was 190/100, Pulse was 126. She was driven to the ER and given 2 injections of Benadryl. Y U 08/14/2001 08/14/2001 0 PUB UNK NONE Codeine causes vomiting; Penicillin causes swelling. LA010802 1
0174773 08/29/2001 FL U 08/22/2001 Information has been received from a pharmacist concerning a patient (demographics unk) who, on an unspecified date, was vaccinated with one dose of pneumococcal vaccine 23 polyvalent (lot # 637263/1448K). It was reported that, on an unspecified date, the patient developed cellulitis and was admitted to a hospital for treatment. The reporter had no further information available at the time of the report. Additional info has been requested. Y Y U UNK OTH OTH UNK UNK WAES01080405 1
0174775 08/29/2001 FL U 08/23/2001 Information has been received from a MA concerning a child who was vaccinated with varicella virus vaccine live. The reporter stated she had heard "in the past, on the news, (that the) child had received (varicella virus vaccine live) and became paralyzed". She further stated that she heard the news report, in 1996 or 1997. She further stated that she delayed vaccinating her child, at the time, because of the report. She did not have any further information regarding this case, but indicated she would attempt to find information regarding the source of the report. It was also noted that her child had since been vaccinated without any problems. The reporter indicated that her original inquiry was regarding the adult dosing schedule for varicella virus vaccine live. Upon internal review, the pt's paralysis was considered to be an "Other Important Medical Event". No further information is available. U UNK OTH OTH UNK UNK WAES01081408 1
0174776 08/29/2001 CT 34.0 33 M 01/16/2002 The pt received his 3rd injection of Lymerix on 6/16/00. Blood analysis performed on 10/7/00 (113 days, post vax, the 3rd Lymerix) as part of an application for life insurance revealed elevated levels of SGOT-56 U/L and SGPT-109 U/L. "Multiple studies" were performed by the vaccine provider and a gastroenterologist. The only finding reported was a positive antinuclear antibody (ANA) titer of 1:64, with an homogenous pattern. A dx of autoimmune hepatitis was made. The autoimmune hepatitis persisted as of 8/4/01. Autoimmune hepatitis is considered "Medically Serious". The follow-up states that pt's medical history included caustic dermatitis present for at least "three to four years" due to solvent exposure, eczema, multiple skin novi, benign hypertrophy of the left massoter muscle, cropitus within joints NOS, left wrist injury resulting in carpal tunnel syndrome 1999, internal hemorrhoids 1991, chornic constipation, and lef tinguinal hernia 1994. Surgical history included left inguinal hernia repair, wisdom teeth removal, vasectomy, and carpal tunnel release. Concurrent medications included multivitamins with iron and Echinacea. Following the reported onset of autoimmune hepatitis, the vaccinee had sinusitis and lower respiratory tract infection, and a single benign retinal hemorrhage in the right eye. These were not reported as adverse events due to vaccine administration, but were found during the course of review of the vaccinee's medical records. Therefore, they are not listed as adverse events. Blood analysis performed on 10/21/99 (121 days after the second injection of LYMErix) as part of an application for life insurance revealed normal levels of SGOT 29U/L and SGPT 37 U/L. However, alkaline phosphatase were elevated 120 U/L. Extensive diagnostic evaluation revealed antinuclear antibody titer of 1:640 with a homogenous pattern, normal white blood cell counts with elevated percentages of monocytes and eosinophils and an elevated LYME BIA with negative IgG and IgM western blot analyses. A diagnosis of autoimmune hepatitis was made, and the vaccinee was referred to a gastroenterologist. The gastroenterologist saw the pt on 12/26/2000. The vaccinee was asymtomatic. At the time of the consultation, the vaccinee was taking multivitamins with iron and Echinecea. The gastroenterologist's assessment was the following: "I discussed with the vaccinee abnormal liver enzymes can be from autoimmune hepatitis which would o along with an elevated antinuclear antibody. We discussed other possibilities such as Alpha 1 deficiency, iron overload from hemochromatosis or Wilson's disease. We sent blood work to look at these possibilities. We also scheduled him to have a liver bioopsy to look at degree of inflammation and damage in his liver. Once we have liver biopsy we will decide whether or not to treat his ANA positive hepatitis." The liver biopsy was performed on 02/24/01. Results were not provided to the vaccine provider, but the vaccinee reported that the biopsy showed "hepatitis." The gastroenterologist subsequently prescribed Imuran and prednisone. SGOT, SGPT, and alkaline phosphatase concentration were within the normal range on 06/19/01 and 07/24/01. A Mentoux tst for tuberculosis, administered 12/10/01, was negative after 72 hours. The most recent info was received from the vaccine provider on 01/04/02. He reported that the autoimmune hepatitis persisted as of 08/04/01. Autoimmune hepatitis is considered medically serious. Y N 06/16/2000 10/07/2000 113 ANA Titer-1:64 with homogenous pattern; 10/23/99 SGOT-29 U/L; 10/7/00 SGOT-56 U/L; 10/21/99 SGPT-37 U/L; 10/7/00 SGPT-109 U/L OTH OTH Multivitamins with iron, Echinacea The physician stated, "he has no underlying conditions that might lead to this"; benign hypertrophy of left masseter muscle, carpal tunnel release, carpal tunnel syndrome, caustic dermatitis, chronic constipation, caripitus within joints, eczema, internal hemorrhoids, left inguinal hernia, left inguinal hernia repair, left wrist injury, multiple skin nevi, vasectomy Elevated alkaline phosphatase concentration was noted 121 days following receipt of the second injection of LYMErix.~Lyme (LYMEr 2001020359 1
0174778 08/29/2001 CT U 08/23/2001 On an unspecified date, the pt received a dose of Engerix-B; it was not known whether the vaccinee had received previous doses of Engerix-B. The physician stated that he has a pt he thought had encephalitis prior to vaccination with Engerix-B. Post vax, the encephalitis symptoms worsened. This event is considered GSK "Medically Serious". As of 8/16/01, the outcome of the adverse event was unknown. U OTH OTH Prior to the vaccination, the physician "thought" that the vaccinee had encephalitis. 20010199881 1
0174780 08/29/2001 OH 4.0 4 F 08/22/2001 This child became limp when leaned into bushes and unconscious on 8/13/01. On 8/19/01, she was found unresponsive and that was X 6-8 hours. EEG showed a spike in right temporal area. These events were felt to be afebrile seizures. Y Y Y 07/27/2001 08/13/2001 17 EEG-right temporal spikes PVT PVT NONE NONE 1
0174781 08/29/2001 CA 1.0 1 .2 M 08/20/2001 Onset of 1st chicken pox lesion on 8/3/01 appeared on his back; on 8/4/01, 6 lesions on back and stomach; on 8/5/01, 15 lesions on back, stomach and both arms; on 8/6/01, 20 lesions on back, stomach, both arms and forehead with conjunctivitis in both eyes; on 8/7/01, 30 lesions on back, stomach, both arms, forehead, inside of mouth, inside of ears, on and around scrotum and 1 on bottom of right foot, on 8/10/01, had yeast infection around scrotum and lesions appeared crusty and began to fall off. He is still recuperating from this episode and is currently fighting a mild upper respiratory tract infection that is not associated with vaccine or prior series of illness'. I feel that his immune system was suppressed by the chicken pox and became more susceptible to the conjunctivitis and yeast infection. The nurse inserted the syringe into small glass bottles and set them on the exam table. I did not see her draw the serum or remove the syringe from these bottles; at which point I was holding my son in position to be immunized. Y U 07/16/2001 08/03/2001 18 PVT OTH NONE NONE NONE 1
0174782 08/29/2001 CA 1.0 1 .0 M 08/24/2001 Approx. 3 hours, post vax, pt had a measly rash over his entire body. He had swelling around his eyes and some coughing. He was brought into the pediatrics clinic and was given an RX for Benadryl. On 8/24/01, child was referred to allergy clinic for evaluation and work-up. Y Y 08/22/2001 08/22/2001 0 MIL MIL NONE NONE Atopic dermatitis 1
0174783 08/29/2001 SC 2.0 1 1 M 07/24/2001 Pt developed a fever within 1 hour, post vax. He had Tylenol before and after, per mom. His temperature ran 100.8F most of the afternoon (Tylenol was given every 4 hours). Mom took temperature prior to leaving child with grandmother and it was 101.6F. Mom says he had a seizure between 20:00 and 21:00. She called MD and then child was taken to ER. Child was iced down and used a wet cloth in ER until fever decreased and returned to normal at 01:00. Y Y 06/27/2001 06/27/2001 0 PUB UNK Tylenol before and after vaccines per mom. NONE Sickle Cell Trait; allergic to Ceclor and Amoxicillin SC0139 1
0174784 08/29/2001 TX 0.7 0 .7 M 08/22/2001 Mother reported onset of fever the day of vaccine. Fever was unrelieved by Tylenol and had no family thermometer. No sponge bath. Normal vomiting and normal intake. Temperature was 104.9F (axillary) at 11:00 on 8/14/01 at the clinic. Sweating child was given Tylenol and clothes removed and sponge bathed. Treatment recommended: alternate acetaminophen and ibuprofen every 3 hours. Child went with mother to see doctor in Mexico on 8/15/01 and received unknown injection and Febrax supps. Situation resolved by 8/16/01. Y Y 08/13/2001 08/14/2001 1 NONE PUB PUB NONE NONE NONE 1
0174785 08/29/2001 GA 1.6 1 .6 F 08/20/2001 Quadriceps reaction secondary to injection in the left thigh. Pt had limping for approx. 1 1/2-2 weeks. She was seen by orthopedist and told to follow-up in 2 weeks if symptoms persisted. Limping resolved. Y Y 07/25/2001 07/28/2001 3 PUB OTH NONE Innocent heart murmur Uncontrolled screaming~DTP (no brand name)~~0.00~In Patient 1
0174786 08/29/2001 CO 1.5 1 .5 F 08/23/2001 Pt screaming with pain for 5 hours; unable to walk for 30 hours. No mass or erythema. Symptom free after 48 hours. Y 08/09/2001 08/10/2001 1 PVT PVT 1
0174787 08/29/2001 AL 0.2 0 .2 M 08/22/2001 On 8/20/01 at 10:40, pt received shots. At 14:05, pt wakes mom from nap crying. His left leg is red and swollen. At 14:20, mom gives pt Tylenol. At 14:30, child is still crying. At 15:00, spoke with mom again and child has continued to cry. On 8/21/01 at 08:00, mom states child cried on and off until 22:00. Child is better today and leg is much less swollen. Y 08/20/2001 08/20/2001 0 PVT PVT NONE NONE Umbilical hernia 1
0174788 08/29/2001 NJ 0.25 0 .3 F 08/22/2001 The following morning, pt had apnea (approx. 2 minutes). Infant became apneic and pale; no seizure or cyanosis. After tactile stimulation, pt started crying and breathing regularly. She was cranky and crying for 15 minutes. Normal examination, after 30 minutes. Y 08/20/2001 08/20/2001 0 NONE PVT PVT NONE NONE Infantile colic 1
0174789 08/29/2001 MS 0.3 0 .3 M Pt was shaking, having a seizure with eyes rolled back but no fever. He was making a slight "clicking" sound with his mouth. Duration unknown exactly. After parent noticed behavior, it lasted a minute or so. Doctor was called. Y 06/07/2001 06/08/2001 1 PUB PUB Tylenol 1
0174790 08/29/2001 CA 2.0 2 .7 M 08/20/2001 The patient experienced urticaria 7 days post vaccination. Y Y 08/10/2001 08/17/2001 7 NONE PVT PVT NONE NONE NONE 1
0174791 08/29/2001 OR 0.6 0 .6 F 08/22/2001 Patient was observed falling asleep in the baby swing by her grandmother. The grandmother states she observed the patient with a glassy eyed fixed stare and extended arms for approximately 2 to 3 seconds and then the patient resumed sleep. Y 08/20/2001 08/21/2001 1 NONE PUB PUB NONE 1
0174792 08/29/2001 IN 1.08 1 .1 M 08/23/2001 Post vaccination, the patient developed a thigh abscess at the injection site. Y U 08/15/2001 PVT UNK 1
0174793 08/29/2001 ME 0.6 0 .6 M 08/13/2001 Approximately 30 minutes after receiving vaccines, the patient became very pale, vomited, and was unable to retain fluids for 3 hours. The patient developed a fever of 101-102F for 5 days. The patient was treated with ibuprofen. The fever was resolved on day 5. The patient's appetite was normal. Y 08/07/2001 08/07/2001 0 NONE PVT PVT NONE NONE ME01033 1
0174794 08/29/2001 CO 1.75 1 .8 F 08/27/2001 Two days post vaccination, the patient developed hives on the lower torso. The hives resolved with treatment of Benadryl. The hives returned over the weekend and on 08/27/2001 woke up in the AM with swelling of her hands, feet, and some in the face and body. Y U 08/20/2001 08/22/2001 2 NONE PUB PUB NONE NONE Viral meningitis, 1 year ago; ~Measles + Mumps + Rubella (MMR II)~1~1.00~In Sibling 1
0174795 08/29/2001 PA 68.0 67 M 08/23/2001 In September 2000, the patient was vaccinated with his 3rd dose of Lymerix. In December 2000 or January 2001, the patient developed inflammatory arthritis. The follow-up states that on 01/29/2001, the pt had swollen wrists. On 02/28/2001, his hand and wrist pain was worse. On 05/09/2001, he had painful hands. On 09/07/2001, the vaccine provider reported that the vaccinee's symptoms were moderate in intensity and were decreasing. However, the physician indicated that the arthritis was diabling/incapicitating. He stated, "these symptoms occurred over 1 year since vaccine. I do not think there is any relationship." Y Y N 09/01/2000 12/29/2000 119 Lyme Elisa - strongly positive; OTH OTH Acetylsalicylic Acid H. pylori carriage; asthma; 2 prior episodes of tick bites; 20010200011 1
0174796 08/29/2001 NJ M 08/23/2001 On 04/20/2000 the patient received his 3rd dose of Lymerix. Reportedly, he "did well" until approximately late April 2001 or early May 2001, when he began to experience headaches, fatigue, and red patches on his torso and legs. His symptoms were never evaluated by a physician. Reportedly, every week after the beginning of May, a new symptom would develop. One day "pinky edema, next morning finger edema" appeared to develop in the middle joints of fingers. The patient stated that the edema traveled to his left knee then to his shoulders. The patient experienced pain. The adverse events "headaches, joint edema, and joint pain" do not meet ICH serious criteria, but are being submitted as an expedited report by special FDA request per the 06/28/2000 letter. Y N 04/20/2000 Parvovirus - Positive; Lyme titer - Positive; PVT OTH Pulmicort; Proventil; Allergic to sulfa; asthma; 20010200361 1
0174797 08/29/2001 OR 48.0 48 F 08/12/2001 On 08/18/2001 the patient experienced a stiff neck, her arm was very sore and twitching, and her shoulder ached. On 08/19/2001 the patient had no improvement in the strength and ability to bend his arm, or the dexterity in his hand. On 08/19/2001 by PM his neck was less sore. The patient has been treated with Advil, Bengay, and heat. U 08/17/2001 08/18/2001 1 PUB UNK Advil NONE Sulfa allergy 1
0174798 08/29/2001 GA 5.0 4 F 08/23/2001 Post vaccination, on 08/08/2001 the patient began with symptoms of toxic synovitis. The next week the symptoms worsened. On 08/17/2001 the patient developed a petechial rash. The patient's labs and symptoms were improving by 08/22/2001. Y Y 07/17/2001 08/08/2001 22 Sedimentation rate - high; CRT - high; PVT PUB NONE NONE NONE 1
0174799 08/29/2001 MS 15.0 0 .1 M 08/22/2001 When the patient was a baby he had a high-pitched cry and high fever for several days. The patient was at home and recovered. The patient is now a teenage and he has huge gaps between his teeth that need corrective work. The dentist said this was caused by a high fever. N 09/30/1985 09/30/1985 0 PUB PVT NONE 1
0174800 08/29/2001 PA 57.0 59 F 08/23/2001 Post vaccination, the patient said her left eye felt funny. About 10 minutes later the felt her left arm felt heavy and her entire body became tingly. The patient's blood pressure was elevated 150/90. No treatment was given. The patient was observed for 1 1/2 hours. Y 08/22/2001 08/22/2001 0 PVT PVT NONE Allergic to sulfa 1
0174801 08/29/2001 DC 8.0 8 F 07/31/2001 Post vaccination, the patient presented with a 50x45mm reaction, resembling a +PPD. The center was red at the site of the injection. The patient's mother stated that "it increased to that size this AM." The patient complained of some itchiness and soreness at the injection site. An area on her left arm was raised. The patient was treated with Hydrocortosone and Benadryl. Y 07/30/2001 07/31/2001 1 PVT PVT NONE 1
0174802 08/29/2001 IN 18.0 18 F 08/20/2001 The patient complained of dizziness, pain in the left arm, thick tongue, and feeling faint within an hour post vaccination. Y Y 08/14/2001 08/14/2001 0 OTH UNK NONE 1
0174803 08/29/2001 NE 44.0 44 M Twenty four hours post vax, the patient developed redness, tenderness, and swelling in the right deltoid. These symptoms occurred immediately following exercise. The patient was treated with aspirin after the injection and following the exercise. Y 08/11/2001 08/12/2001 1 MIL MIL Vitamins E, C, and multi; NONE Allergy to Penicillin 1
0174804 08/29/2001 SC 22.0 22 F 08/16/2001 Post vaccination, the patient complained of her arm itching within 10 minutes. The patient complained of generalized itching of the arms, legs, face and lips, and 3 hives or rash. After about 40 minutes the patient complained of throat tightness. The patient was treated with Benadryl with some relief in 10 minutes. The patient was transferred by EMS to the ER at 11:02. Y Y 08/16/2001 08/16/2001 0 NONE PUB PUB Insulin; NONE IDDM SC0140 1
0174805 08/29/2001 KY 4.0 4 F 08/25/2001 The patient's mother called on 08/23/2001. The patient developed crying since receiving the vaccine, throwing up, a headache, weakness, and feels feverish. The patient has been treated with Tylenol and Motrin but does not get relief. The patient went to a physician who feels her symptoms may be due to the vaccine. The physician gave the patient some medicine for a cold and runny nose. Y U 08/21/2001 08/21/2001 0 NONE PUB OTH NONE NONE 1
0174806 08/29/2001 NY 5.0 5 F 08/23/2001 Post vaccination the patient developed a red, swollen, tender, indurated area 6x6cm at the injection site. The patient was treated with Keflex. Y 08/20/2001 08/22/2001 2 NONE PVT PVT NONE NONE 1
0174807 08/29/2001 AZ 15.0 15 F 08/10/1986 The patient left the clinic after receiving immunizations. The patient's sister came back into the clinic stating the patient had fainted in the parking lot. The nurse noted the patient was alert and oriented, lying on the backseat of a car. The patient's mother stated the patient had a seizure in the parking lot and she had called paramedics. The patient was transported to the hospital for evaluation. Y U 08/18/2001 08/18/2001 0 UNK OTH PUB UNK UNK UNK 1
0174808 08/29/2001 MI 22.0 22 F 08/23/2001 Post vaccination, the patient experienced dizziness, nausea, weakness, headache, body aches and a stiff neck. Y Y 08/20/2001 08/20/2001 0 PUB PVT NONE NONE Allergic to PCN, erythromycin, neomycin, and sulfa. rash, dyspnea, fever~Pertussis (no brand name)~1~0.25~In Patient|~Measles + Mumps + Rubella (MMR II)~1~1.00~In Sibling 1
0174809 08/29/2001 CA 12.0 12 F 08/11/2001 The patient's father stated that the patient was kneeling against the wall after receiving vaccinations. The patient felt dizzy and faint for a few minutes, then recovered. Y 08/01/2001 08/01/2001 0 PUB PUB CA010088 1
0174810 08/29/2001 OH 1.3 1 .3 M 08/22/2001 Mother stated child had DTAP 8/15/01 in the PM. Pt's right thigh became reddened and edematous. Mother stated it spread. Pt was taken to the ER in the evening of 8/16/01. Zithromax was ordered. Mother stated redness subsided without further treatment. Y Y 08/15/2001 08/16/2001 1 PUB PUB NONE NONE Allergy to penicillin 1
0174811 08/29/2001 CA 35.0 35 F 05/01/2001 Post vax, pt's arm hurt for a day, and it was very, very bruised. 04/26/2001 04/27/2001 1 PVT PVT 1
0174812 08/29/2001 CO 5.0 5 F 08/21/2001 Pt developed erythema, mildly increased warmth, induration and hives on left leg at site of IPV injection. Y 08/12/2001 08/16/2001 4 NONE PVT PVT NONE NONE NONE 1
0174813 08/29/2001 PA 3.0 3 F 08/23/2001 Pt's mother reported that pt had red, raised areas about the size of mosquito bites on bilateral anterior thighs extending to groin area that were noted about 1 hour post vax and increased in size since. The areas were itching per patient. 08/20/2001 08/20/2001 0 PVT OTH Nasonex NONE Exercise-induced reactive airway disease 1
0174814 08/29/2001 FL 35.0 35 M Pt complained of swelling and tenderness to site. Y 08/17/2001 08/18/2001 1 PVT PVT 1
0174815 08/29/2001 MO 5.0 5 M 08/23/2001 Pt developed an inflammatory reaction in upper arm extending distally to beyond elbow. He was also noted to have a possible small amount of periorbital edema. U 08/21/2001 08/22/2001 1 NONE PVT PVT NONE NONE NONE 1
0174816 08/29/2001 AL 4.0 4 F 08/23/2001 Pt's mid left thigh became warm to touch with slight edema measuring 9 x 12 cm round. Mother noticed this on 8/23/01 when child got up. She was treated with a cool cloth on leg throughout the day. Y 08/21/2001 08/23/2001 2 PVT PUB Bactrim Urinary tract infection E coli urinary tract infection, dysuria, polyuria 1
0174817 08/29/2001 NY 23.0 23 M 08/17/2001 Two hours post vax, pt developed a vesicular rash over abdomen. He was instructed to take Benadryl 50 mg po x 1. He did not have difficulty breathing, hoarseness or pruritus. He was instructed to go to ER if symptoms worsened. Y U 08/16/2001 08/16/2001 0 NONE PVT PUB NONE NONE NONE 1
0174818 08/29/2001 WI 5.0 5 M 08/22/2001 Pt developed generalized urticaria within 24 hrs of vaccine administration. He had no dysphagia, dyspnea or mucous membrane involvement. Y Y 08/21/2001 08/21/2001 0 NONE PVT PVT NONE NONE Hives with EES/Sulfa 12/96 1
0174819 08/29/2001 WI 5.0 5 M 08/23/2001 Pt developed redness, swelling and warmth to left thigh and knee. He began limping due to leg pain. He was seen in MD's office 2 days post vax. Mother states leg had hurt since injections on 8/21/01, and pt started limping on 8/22/01. The swelling, redness and warmth occurred 8/22/01-8/23/01. Y U 08/21/2001 08/22/2001 1 NONE PVT PVT NONE NONE Rash due to amoxicillin 1
0174820 08/29/2001 MI 2.0 2 .3 M 08/02/2001 Pt developed right leg edema at knee. Mother stated it was approximately twice the size as it usually was. There was no redness at injection sites, only lower thigh and around knee. Mother denied any heat to touch at site or fever. Pt complained of mild discomfort. Pt continued to run and play. He was treated with Children's Motrin and cool packs to site. Y 08/01/2001 08/02/2001 1 PUB UNK NONE NONE 1
0174821 08/29/2001 NV 42.0 42 F Pt noted she felt "weakness, dizzy, woozy like an out of body experience" beginning 4:45 PM on the day of receiving vax. There were no anaphylactic symptoms. The weakness continued until 2:00 AM but the dizziness stopped at 9:30 PM. Y 08/21/2001 08/21/2001 0 NONE PUB PVT PPD Aventis Pasteur C0835AA intradermal left forearm 8/21/01, topical Metrocream bid NONE Allergy to morphine, Mandol, penicillin, and Easter lillies 1
0174822 08/29/2001 UT 1.25 1 .3 M 08/22/2001 Pt broke out with a fluid-filled rash. He was seen in the office the next afternoon, and the rash was confirmed to be varicella by MD. Y Y 12/26/1996 08/21/2001 1699 PVT PVT none Upper respiratory infection NONE 1
0174823 08/29/2001 IA 4.0 4 F 08/16/2001 Approximately 10 minutes post vax, mother brought child back into clinic area and stated that child was talking, holding onto her arm when she went "limp, eyes rolled back" and she hit her head on pavement. She was not moving. Pt immediately placed on exam table and immediately began crying, was alert and talking. Her color was pink and she was noted to have a slight scrape on right knee. There were no bumps or abrasions noted on head. Parents instructed to phone MD re: incident. At 5:15 PM, pt walked out without problems. Phone call at 6:30 PM revealed mother took pt to MD as she became "pale" on ride home. Nothing was found. Pt did have emesis but was playing without problems. Phone call on 8/17/01 revealed pt had decreased appetite, was complaining of stomach ache but was playing at child care with some fussiness. Y Y 08/16/2001 08/16/2001 0 NONE PUB PUB NONE NONE NONE 1
0174824 08/29/2001 TX 14.0 14 F 08/28/2001 Four hours post vax, pt developed a fever of 102 and hallucinations. Y 02/12/2001 02/12/2001 0 NONE PUB PUB NONE NONE NONE 1
0174825 08/29/2001 TN 2.0 2 .0 F 08/16/2001 Pt developed a 3 cm round, red circle at site of Hepatitis B. The reaction site was edematous and blanched. Pt was treated with Benadryl, 3/4 tsp q6h. Consider cellulitis per MD. Y Y 08/14/2001 08/15/2001 1 NONE PVT PVT NONE NONE 1
0174826 08/29/2001 PA 8.0 2 .0 F 08/22/2001 Pt developed several chicken pox that lasted less than 10 days. She had less than 25 pox. Paternal grandfather had shingles, and pt was exposed during incubation. Y 06/22/1995 08/09/2001 2240 PVT PVT NONE NONE NONE 1
0174827 08/29/2001 WA 4.0 4 M 08/16/2001 Pt developed passive swelling of the left triceps, 13.0cm vertically and diameter from 15.4-18.0cm with mild erythema. No pain or bother to the child. On 8/21/01, pt fully recovered, per mom. Y 08/14/2001 08/15/2001 1 PVT PUB NONE NONE NONE 1
0174828 08/29/2001 CA 7.0 7 M 08/24/2001 A 7 year old received the 1st dose of Hep-A vaccine and 5 minutes later, while in the waiting room, he suddenly fainted. Blood pressure was normal. He was pale. He saw the blood coming on the PPD test site, 1 minute before fainting. Y 08/24/2001 08/24/2001 0 NONE PVT PUB PPD skin test NONE NONE 1
0174829 08/29/2001 PA 4.0 1 .2 F 08/22/2001 Called office with complaint of rash that sounded like chickenpox. No fever or sickness; course of chickenpox described and told caller to call back if any complications. U 07/20/1998 08/10/2001 1117 NONE PVT PVT NONE Anemia 1
0174830 08/29/2001 NY 1.3 1 .3 M Pt developed erythema and induration at right upper arm below DTAP vaccination point. Range of motion (+). U 08/09/2001 08/11/2001 2 NONE PUB PUB 1
0174831 08/29/2001 NY 0 .0 M 08/09/2001 Newborn boy received Hep-B vaccine at 15:20 on 8/1/01. Fifteen minutes later, the RN noticed the baby was cyanotic and not breathing. The baby was stimulated and O2 via face mask was given and baby turned pink. Baby was transferred to NICU and discharged on 8/2/01. Y Y 08/01/2001 08/01/2001 0 UNK UNK Erythromycin ophthalmic ointment; phytonadione 1mg IM NONE 1
0174832 08/29/2001 NY 1.0 1 .1 F 08/27/2001 Pt's father reports that for 2 days, the pt had eruption of papules on trunk, extremities and face (some weeping with fluid). Treated with calamine lotion and Aveeno bath and Tylenol if has a fever. U 07/18/2001 08/25/2001 38 NONE PVT OTH NONE NONE NONE 1
0174833 08/29/2001 IL 8.0 8 F Mom states, while walking to exit, pt fell to ground, face fluctuated, eyes rolled back for a few seconds and then awoke and stood up and stated she felt nauseous. Questionable seizure; probably vasovagal episode. Y 08/21/2001 08/21/2001 0 PVT PVT 1
0174834 08/30/2001 CA 4.0 4 F 08/23/2001 50mm diameter lesion, with tenderness and erythema, noted after shots given and getting larger. Y 08/16/2001 08/17/2001 1 NONE PVT PUB NONE NONE 1
0174835 08/30/2001 TX 1.7 1 .7 M 08/28/2001 Pt developed fever, prolonged crying and brief (about 2 minutes) of generalized seizure. Y Y 08/09/2001 08/09/2001 0 NONE PUB PUB NONE NONE NONE 1
0174836 08/30/2001 VT 21.0 20 M 08/07/2001 Onset of itchy hives 1 hour after yellow fever vaccine given. Pt had also just worked out. No SOB, dysphagia or wheezing. Responded well to Benadryl 25 po. Y Y 07/10/2001 07/10/2001 0 NONE PVT UNK SVT with cardiac ablation as a teenager 1
0174837 08/30/2001 TX 63.0 63 F 08/23/2001 Pt developed a rash beginning 2 days, post vax. Started on face and arms and progressed to trunk area and legs. Pt saw her PMD and he gave her an "antihistamine". Y Y 08/14/2001 08/16/2001 2 PVT PVT Premarin, Digoxin NONE Codeine allergy 1
0174838 08/30/2001 CA 3.0 3 F 08/29/2001 Pt developed a fever to over 104F without localizing signs. Fever lasted x 4 days. Y Y 08/20/2001 08/23/2001 3 U/A-(-) for infection PVT UNK NONE NONE NONE 1
0174839 08/30/2001 MA 4.0 4 M 08/28/2001 Pt developed red and swollen arm area of approx. 6"-8". Treatment: monitor for increased swelling, temperature, etc. Y 08/23/2001 08/24/2001 1 NONE PVT PUB NONE NONE NONE 1
0174840 08/30/2001 WI 26.0 26 F 08/18/2001 Pt developed swollen lymph nodes in neck, headache, pain in neck and aches in joints of ankles and knees. Y 08/08/2001 08/17/2001 9 PUB PVT NONE NONE NONE 1
0174841 08/30/2001 OH 6.0 6 M 08/27/2001 Pt developed a fever X 48 hours, post vax, along with being irritable. U 08/22/2001 08/23/2001 1 PVT PVT NONE NONE NONE 1
0174843 08/31/2001 CO 1.4 1 .5 F 08/28/2001 A pediatrician reported that a 17 month old female received injections of Prevnar, MMR, and varicella vaccines on 10/18/2000. She was noted to be a healthy child with no past history of illness and no pre-exititng illness at this time of vaccination. The child was found dead in her crib on 10/26/2000. Sudden Infant Death Syndrome was reported. An autopsy was reported to be negative. NOTE: this report of a serious, labeled event (SIDS) is being submitted in a 15 day time frame as requested by the FDA. Y 10/26/2000 N 10/18/2000 10/26/2000 8 UNK OTH OTH UNK Autopsy report was negative NONE HQ5280128AUG2001 1
0174844 08/31/2001 FL 1.65 1 .6 F 08/22/2001 The pt cannot walk properly; she is very unsteady on her feet. While on prednisolone, does make progress. If dose is reduced, walking gets worse or she stops walking. She got very insecure and frightened and scared. Diagnosed with transverse myelitis. Y Y 16 Y N 02/13/2001 02/15/2001 2 Done at medical center PVT PVT Finished 10 days of Amoxil NONE NONE 1
0174845 08/31/2001 NC 12.0 12 M 08/27/2001 Recovering from a stroke he suffered 3 months ago. Post vax, the pt woke up the next morning with his right arm weak and right leg completely numb. The right side was affected by the stroke. Complained of stomach ache after eating 2 bites of a hamburger last night and stomach still hurts today, 11/29/99. Saw a psychiatrist and was put of Paxil. Also seen by a psychologist about 1 week ago and bumped head on right and made a complaint of left sided weakness. Seen in ER and CT Scan was nml. He still feels tired and bruising more on Plavix with nausea. Scattered ecchymosis in various stages of healing over arm and legs. Dx'd with mild epigastric pain and gastritis and probable constipation. Senokot prescribed X 1-2 days. Has been walking with a cane but had not needed it after rehabilitation until the morning of 11/3/99 because of weakness and numbness in left side. Right arm has purpura and less strength than usual same as stroke. Dx'd with possible TIA. Hospitalized for more tests. Had a fainting spell at school on 12/1/99 and was out for about 20 seconds. He was complaining of a headache and dizziness for 1 hour after the episode. He has increased bruises per dad but he is on blood thinners and aspirin. Called dad on 12/4/99 at 12:00, to check on pt per doctor's request and no more fainting or constipation in several days; seems to be doing ok per dad. Y Y N 11/02/1999 11/03/1999 1 MRI of the brain at UNC Hospital on 11/03/1999. Results showed that there were no changes. PVT PUB aspirin, Plavix, Paxil NONE Ischemic stroke; Left basal ganglia 8/99 1
0174846 08/31/2001 ND 20.0 20 M 08/30/2001 Slight chest tightness, redness and swelling around the eyes, at 08:45, 0.5ml EPI 1:1000 given. Y Y 08/30/2001 08/30/2001 0 MIL MIL NONE NONE 1
0174847 08/31/2001 WA 1.4 1 .4 M 07/23/2001 Onset of apparent seizure disorder on 7/19/01. Doc 207958 states no further seizures but still on anticonvulsants. Y Y 2 U 07/09/2001 07/19/2001 10 Neuro consult, CT scan, LP, EEG, CBC with differential and BMP. No results reported. PVT PUB NONE NONE 1
0174848 08/31/2001 TN 1.08 1 .1 F 08/17/2001 Pt had a seizure lasting around 45 minutes. taken to ER by ambulance. Given Tylenol, Ativan, Rocephin, and Vancomycin. Y Y 2 Y 05/01/2001 05/09/2001 8 Mom says tests done at Vanderbilt University Hospital did not show anything. PUB PUB NONE NONE Premature @ 34 weeks, jaundice. 1
0174850 08/31/2001 WV 3.0 3 F 08/25/2001 Dr diagnosed client with Henoch Schonlein Pupura after immunization. No treatment. Y Y 01/23/2001 01/24/2001 1 NONE PUB PVT NONE NONE NONE WV0111 1
0174851 08/31/2001 CA 1.0 1 .0 F 08/13/2001 This patient was seen on 08/02/01 for a well child visit. Vaccinations given MMR, Varivax, Prevnar, and Hep B # 3. 10 days later this patient developed a fever and a morbilliform rash on her face and upper arm. Y Y U 08/02/2001 08/10/2001 8 NONE PVT UNK Tylenol NONE NONE 1
0174852 08/31/2001 VA 27.0 27 F 11/21/2000 At 1:35 pm on 11/17/00, this patient arrived to the health dept complaining of hives and itching of the upper torso. Symptoms progressed. The itching intensified, restless. Complains of throat discomfort. Wheezing noted. The patient was transported to the ER via rescue unit. She received Epinephrine, Benadryl, breathing treatment, and Prednisone. Y Y 11/17/2000 11/17/2000 0 No Test. PUB UNK PPD, Connaught, lot #C0152AA, intradermal left forearm. NONE Asthma 1
0174853 08/31/2001 CA 4.0 4 F 07/05/2001 This patient had swelling and redness involving 2/3 of the right arm (site of injection). Y U 06/28/2001 06/29/2001 1 PVT UNK 1
0174854 08/31/2001 CA 1.7 1 .7 M 06/26/2001 On 06/20/01: Prevnar (pneumococcal) vaccine administered on the right deltoid, a red mass developed at the site of the injection. On 06/21/01: red "ball" mass continued at the site of injection. On 06/22/01: red small rash developed at the site of the injection. Denies any other symptoms. Y 06/20/2001 06/20/2001 0 NONE PUB PUB NONE NONE 30 Weeks premature infant. 1
0174855 08/31/2001 IN 4.0 4 F 06/20/2001 This patient developed 11 1/2 x 9 1/2 cm area of redness, tenderness and mild induration at the site of vaccination on the right thigh. The patient complains of some pain but no difficulties walking. Seen 06/20/01. Treatment: Zyrtec, Zithromax (for possible cellulitis), ice. U 06/18/2001 06/20/2001 2 PUB PUB NONE NONE NONE 1
0174856 08/31/2001 OH 0.2 0 .2 M 06/27/2001 Pt developed screaming starting shortly post vax until 10 PM. He would settle down for a few minutes a couple of times. He developed fever to 101 all evening. The next day, he wanted mother to hold him. He was very listless and and "eyes glassy." Y 04/10/2001 04/10/2001 0 NONE PUB PUB NONE NONE NONE 1
0174857 08/31/2001 AZ 0.75 0 .8 F 07/06/2001 This infant had left leg erythema 3 cm, 2 cm induration. No treatment. U 07/05/2001 07/06/2001 1 PUB UNK NONE 1
0174858 08/31/2001 AZ 1.0 1 .4 M Approximately 10 cm red patch on the left thigh at the injection site, 1.2 cm hard knot . Y Y 07/10/2001 07/12/2001 2 NONE PVT PVT NONE NONE NONE 1
0174859 08/31/2001 PA 43.0 43 M 07/16/2001 5/20/01 pt developed discomfort of left anterior thigh. 5/26/01 pt developed headache, fever, myalgias, arthralgias, upper back and leg pain. on 6/12/01, systemic symptoms had resolved but pt still had left leg pain. Y Y 05/10/2001 05/20/2001 10 05/27/01 CBC, CMP-OK PVT PVT Glucotrol XL, Avandia NONE Type 2 diabetes 1
0174860 08/31/2001 TX 1.2 1 .2 F 07/07/2001 This infant had a fever greater than or equal to 102 for 5-6 days with petechial type rash. Phone consult with Peds ID specialist suggested probable viral infection rather than vaccine related. Y Y 06/20/2001 06/21/2001 1 Blood culture and Urine culture - Negative. ESR 52, CRP 3.2, Mono 11, Sep 36. PVT PVT NONE 1
0174861 08/31/2001 TN 0.5 0 .5 M 08/23/2001 Pt developed wheal around Prevnar site and then developed papular rash all over body. He had no GI or respiratory symptoms. 08/21/2001 08/21/2001 0 PVT PVT NONE NONE Torticollis 1
0174862 08/31/2001 AK 3.0 3 F 08/13/2001 This child had a fine rash on her arm , face, back, and neck the next day following immunizations. Y Y 08/11/2001 08/12/2001 1 PUB OTH NONE NONE 1
0174863 08/31/2001 AZ 0.2 0 .2 F 08/10/2001 Petechial rash throughout body, mother saw wheals that quickly resolved. One episode of apnea (she was having these before). Y Y 08/10/2001 08/10/2001 0 PVT PUB NONE One previous apnea spell 1
0174864 08/31/2001 NY 1.0 1 .0 M 08/07/2001 Received varivax vaccine on 8/7/01 in the office. A few minutes, post vax, a hive developed near the injection site. Ice pack applied and 1/2 tsp Benadryl given. Waited in office for 30 minutes with no further adverse reactions noted. Y Y 08/07/2001 08/07/2001 0 PVT OTH Conjunctivitis 1
0174877 08/31/2001 MD 59.0 58 F 08/27/2001 On 8/4/01, pt had lack of energy; on 8/5/01, she went for a hike and thinks she got dehydrated so she drank water; later afternoon she had a fever of 102F and took aspirin and felt much better by 20:00. On 8/6/01, she felt good; got hepatitis B #3 vaccine in the morning; on 8/7/01, pt had a headache in the evening, rather strong so she took ibuprofen. She also had profuse sweating from head/neck/chest area at night. On 8/8/01, she had strong headache in the evening and woke up with a strong headache at 03:00 so she took ibuprofen and Tylenol and still had profuse sweating from head/neck/chest area at night. On 8/9/01, still with same symptoms so on 8/10/01 she saw MD in Infectious Diseases in the afternoon and he ordered a battery of tests, blood work and a CT of head. On 8/11/01, had a very mild headache at midday so took Advil. On 8/12/01, felt ok; on 8/13/01, felt ok and had blood work done which showed Alkaline phosphatase, AST and ALT were very high. On 8/14/01, she felt ok but a rash had appeared on her abdomen on either side of the midline and the area was about 2 X 4, they were eruption, not blisters, slowly disappeared over the next 3 days and by 8/17/01, they were gone; rash was not itchy. On 8/15/01, no other symptoms. On 8/22/01, saw MD and CT test returned as normal; he ordered an abdominal sonogram to make sure gallbladder, liver and pancreas are OK; sonogram scheduled for 8/28/01; he ordered liver function enzymes to be redone and I will redo that on 8/27/01. U 08/06/2001 08/07/2001 1 CT test-nml; Blood work showed AST and ALT were very high; lymphs were high and polys were low; Glucose serum 114 (high); Alkaline phosphatase, serum-314 (high) PVT PVT Complained of lack of energy NONE 1
0174878 08/31/2001 OK 33.0 32 F 08/30/2001 This patient had an injection at 2:00 PM on 08/29/2001. She felt funny all afternoon, off balance. She went back to bed, awoke a 3:00 AM having difficulty breathing. Glands, throat all swollen. Tingly fingers and toes. No fever. Stiff neck, headache, queasy stomach, heart beating fast, sore throat when she swallows (hard to swollow), also feels spacey and dizzy. Y U 08/29/2001 08/30/2001 1 X-ray PUB UNK Levoxyl, Pepcid, Benadryl. 1
0174879 08/31/2001 CT 1.5 1 .6 M 08/21/2001 Extreme swelling and pain in left arm to fingers and slight swelling in neck on same side. Also, complained of itching in area. Treated with cold compresses and Claritin. Y Y 08/20/2001 08/21/2001 1 NONE PVT PUB Elocon ointment; vitamins NONE NONE 1
0174880 08/31/2001 KY 51.0 51 M 08/23/2001 This donor previously took Tetanus injections February 2001 and experienced a "deep throbbing pain" bilaterally in arms and shoulders. Did not associate this occurence with injection. He began to have same signs and symptoms after the injections on 06/25/01. The patient states that pain would alternate b/w arms lasting at 15 minutes. Pain is ongoing. N 06/25/2001 06/25/2001 0 OTH OTH NONE NONE NONE 1
0174881 08/31/2001 FL 0.3 0 .4 F 08/26/2001 This infant had a diffuse homogenous erythematous rash on her trunk and face, with swelling of her nasal bridge and mouth as per her father. It occurred one hour post immunization. She was seen in the ER and treated with Prelone. Y Y 08/23/2001 08/23/2001 0 NONE PVT PUB NONE NONE NONE 1
0174882 08/31/2001 SC 0.5 M 08/24/2001 This infant had a fever of 102-103 for three days following immunization. On 08/24/01 still 101. Y 08/20/2001 08/20/2001 0 PVT PUB NONE Healthy six month old. NONE Fever of 102 degrees.~Pneumo (Prevnar)~1~0.50~In Patient 1
0174883 08/31/2001 NY 47.0 47 F 08/28/2001 Urticaria of torso. Treated with Benadryl 50mg po Tid. Y Y 08/17/2001 08/17/2001 0 PUB UNK NONE NONE 1
0174885 08/31/2001 CA 0.3 0 .4 M 08/24/2001 Post vax, the pt's left extremity turned red and hard from his thigh down to his toes. Pt cried loudly for 30 minutes. Benadryl was given and the pt recovered within 30 minutes. Y 08/24/2001 08/24/2001 0 NONE PVT PVT NONE NONE NONE 1
0174886 08/31/2001 NC 39.0 39 F 08/27/2001 Arm swollen (left) and red after tetanus shot; 43mm X 41mm (red, hot and swollen). Y 08/03/2001 08/04/2001 1 PVT UNK NONE NONE 1
0174887 08/31/2001 CO 4.0 4 M 08/24/2001 At 11:25 gave MMR in this child's right arm sq and IPV in his left arm sq. Approximately 2-5 minutes later the child had 2-3 mm hive like welts 1 cm above the injection site. Over the next 2 minutes the welts joined and became approximately 1 cm raised red area. Redness 5 cm around injection site. No hives anywhere else, no respiratory distress, Benadryl given. Patient was observed for 20 minutes. Discharged. Advised to return if SOB, wheezing, more hives or redness lasting longer than 1-3 days. Y 08/24/2001 08/24/2001 0 PVT PVT Vitamins NONE NONE 1
0174888 08/31/2001 TX 4.0 4 F Pt developed diffuse urticaria. No wheezing or retraction. Treated with Epi along with 2 tsp Benadryl and within 30 minutes, urticaria was decreased. Y 08/28/2001 08/28/2001 0 PVT PVT NONE NONE Allergy to eggs 1
0174889 08/31/2001 WV 2.0 0 .2 M 08/27/2001 On 6/25/01, within 12 hours, post vax, the pt developed a fever of 102F and incessant and inconsolable crying for 30-45 minutes. Y Y 06/25/2001 06/25/2001 0 PVT UNK NONE NONE 1
0174890 08/31/2001 MA 1.5 1 .5 M 06/21/2001 This infant had 0.8 cm x 5 cm irregular, slightly raised erythematous area on his left thigh. A- local reaction, B- observe. Y 06/20/2001 06/21/2001 1 NONE PVT PUB NONE NONE NONE 1
0174891 08/31/2001 CA 4.0 4 F 08/23/2001 This child's left arm was swollen, and hot to touch at the injection site. Diagnosed with cellulitis. The patient was prescribed Keflex. Y 08/20/2001 08/21/2001 1 PVT PVT NONE 1
0174892 08/31/2001 CA 25.0 25 F 07/11/2001 This client felt faint with in 15 minutes of receiving TT, had to lye down. Ambulance phoned and monitored client. Y 07/11/2001 07/11/2001 0 NONE PUB PVT NONE NONE 1
0174893 08/31/2001 AZ 18.0 18 F 07/12/2001 On 07/05/01, this patient's mother reports the patient was experiencing, dizziness, nausea, skin flushed, and warm to touch. This began the next day 07/04/01 after MMR was taken. On 07/09/01, this mother reports the child was seen in the ER on Saturday 07/07/01 with swollen lips, areas of the throat and mouth swollen, and rash on her arms. The ER gave her steroids and Benadryl. Y Y 07/03/2001 07/04/2001 1 PUB PUB NONE NONE 1
0174894 08/31/2001 CA 0.08 0 .1 F 06/29/2001 Pt developed severe irritability with non-stop crying for 24 hours. Y 06/27/2001 06/27/2001 0 NONE PVT PVT NONE NONE 1
0174895 08/31/2001 IL 9.0 9 F 07/13/2001 Pt developed a rash, located on trunk, thighs and waist. No hives. Complained of a sore throat, no respiratory distress instructed to take over-the-counter Benadryl. Follow-up scheduled for 7/30/01. Y U 07/12/2001 07/12/2001 0 PUB PUB 1
0174896 08/31/2001 IL 5.0 1 .0 F 07/11/2001 Pt developed vesicular lesions on arms and torso. Y U 06/09/1997 07/10/2001 1492 PVT UNK 1
0174897 08/31/2001 OH 4.0 4 M 07/27/2001 On 7/24/01, pt developed a fever. On 7/25/01, his cheeks were bright red with welts. On 7/25/01 and 7/26/01, the rash was over entire body; worse on legs and feels rough. It was lighter on back and chest. The child told mom he was sunburned which was not possible per mom. When sleeping on 7/26/01 AM, his cheeks were not red. When up and about, his cheeks would get very red again. Had a low-grade fever for about 1 week, post vax, which lasted a couple of days and was fine until he had a fever again on 7/24/01. Y 07/05/2001 07/24/2001 19 NONE PUB PUB NONE NONE Frequent tonsillitis 1
0174898 08/31/2001 CA 4.0 4 M 07/23/2001 Right upper arm was swollen, red and hot. Girth of right upper arm was twice the size of the left upper arm. No tenderness on 7/20/01. Rechecked on 7/23/01 and all of the above symptoms were resolved. Y Y 07/18/2001 PVT PVT NONE NONE NONE 1
0174899 08/31/2001 CA 4.0 4 M 07/16/2001 Pt developed induration on right deltoid with a 3x5 area of tenderness. 07/11/2001 07/12/2001 1 NONE PVT PVT NONE NONE 1
0174900 08/31/2001 VA 18.0 18 F 07/16/2001 Pt developed swelling of right jaw, pain in right ear and neck, wheezing and fever. She denies any rash. Y 07/13/2001 07/13/2001 0 PUB PUB NONE NONE NONE 1
0174901 08/31/2001 MN 42.0 42 M 07/16/2001 Pt developed hives to entire body and a mild fever. He used Benadryl x 3 days. Y Y 01/03/2001 01/03/2001 0 NONE PUB PUB NONE NONE Allergic to grain dust 1
0174902 08/31/2001 NY 5.0 5 M 08/17/2001 At 5:50 PM on day of receiving vax, pt's mother called office stating pt was having an allergic reaction. He had a red rash all over body, was very itchy, and was "breathing noisey." At 6 PM pt arrived in office alert/oriented with generalized urticaria and diffuse, mild wheezing. He was given Zyrtec 10mg po and Xopenex 0.63% via nebulizer. His chest cleared and rash was fading. He was sent home with Xopenex tid and Benadryl 25mg q6h 2 24 hrs. Y Y 08/16/2001 08/16/2001 0 Pulse ox 97% PVT PVT NONE NONE Wheezing with bronchitis since 2/97 1
0174903 08/31/2001 NV 23.0 23 M 08/08/2001 Pt complained of being lightheaded and chest felt heavy. Y Y 08/07/2001 08/07/2001 0 NONE PVT PVT NONE Recovering from cold/flu NONE 1
0174904 08/31/2001 OH 54.0 54 F Pt complained of fatigue, left arm numbness and tingling, muscle aches, arthralgia, joint swelling and 1 cm superficial ecchymosis on upper left deltoid at injection site. Pt was seen by MD on 8/2/00. Y U 07/26/2001 07/26/2001 0 PVT PVT Evista, ASA NONE NONE 1
0174905 08/31/2001 MA 5.0 5 M 08/10/2001 Pt developed anaphylaxis, swelling and hives. He improved with subcutaneous epinephrine. Y Y 08/10/2001 08/10/2001 0 NONE PVT PUB Epi-pen NONE Allergies to penicillin, azithromycin and various dyes 1
0174906 08/31/2001 NY 1.0 1 .0 M Pt presented to MD office on 7/31/01 with a rash but no fever. He was positively diagnosed by MD with chicken pox. Y U 01/11/2000 07/31/2001 567 PVT UNK Roseola rash NONE 1
0174907 08/31/2001 NY 1.08 1 .1 F 08/02/2001 Pt recvd Varivax 7/11/96 and broke out with a mild varicella rash mid May 2001. Y 07/11/1996 05/15/2001 1769 PVT UNK 1
0174908 08/31/2001 CA 2.0 2 .1 M 07/09/2001 Pt developed a local erythematous, urticarial rash 5 days post vax which persisted for another 5 days. He was treated with antihistamines. 06/25/2001 06/30/2001 5 PVT PVT NONE NONE 1
0174865 09/04/2001 TX 5.0 5 F 08/22/2001 On 8/12/01, pt had a headache; on 8/14/01 pt had a headache and a fever; on 8/15/01, the pt was lethargic; on 08/17/01, pt had herniation and on 8/18/01; life support removed. Death certificate states cause of death to be cerebral edema due to viral illness. Y 08/18/2001 Y Y Y 4 N 08/08/2001 08/12/2001 4 Autopsy results state histologic findings are most consistent with a viral etiology, however, antemortem serologic tests and postmorterm cultures fail to elucidate the etiology. Although ADEM was considered, stains failed to demonstrate a demyelinating process as is classically demonstrated in this lesion. PVT OTH NONE NONE NONE 1
0174866 09/04/2001 NY 44.0 43 F 08/28/2001 Employee states that on the day of her varivax #3 administration, later that day, she did not feel weak but describes hot/cold and fever of 101.2F. Y 08/16/2001 08/16/2001 0 NONE PUB UNK Vasotec NONE Hypertension 1
0174868 09/04/2001 TX 0.6 1 .6 M 08/16/2001 This infant's mother stated that on 08/15/01 at 4 PM this child had a severe asthmatic reaction, turned blue, retractions and rales. Taken to the ER 9 PM at the hospital until Wednesday afternoon. Y Y Y 2 Y 08/13/2001 08/13/2001 0 UNK PUB PUB Albuterol NONE Asthma (parents did not tell the RN at the time of the immunizations). TX00121 1
0174869 09/04/2001 TX 4.0 4 M 08/17/2001 This child had a seizure in the afternoon, paramedics were called. Arrest- stabilized and transported to CMH. EEG, Spinal Tap with CNS done, MRI completed on 08/16/2001. No diagnosis yet. Child still hospitalized. Y U 08/14/2001 08/15/2001 1 Spinal Tap with CNS, UR, EEG, MRI. OTH PUB NONE NONE TX00120 1
0174870 09/04/2001 TX 0.4 0 .4 F 08/17/2001 One day after vaccine, it was reported the pt had loss of consciousness, then was sleepy for about 10 minutes. Temperature was 99.2 AX. No color change. No seizure activity. Was in very hot house without air conditioning and then event occurred. Recovered without treatment. Was seen in ER after event and then the MD'S office. Y Y 08/14/2001 08/15/2001 1 Had normal glucose and oxygen saturation by report at hospital. PVT PVT NONE Cold noted on 8/16/01 NONE 1
0174871 09/04/2001 TX 7.0 0 .6 F 08/17/2001 Seemed out of it for a little while, drooling out side of mother , then fell asleep, per mother Y Y 08/16/2001 08/17/2001 1 NONE - observe PVT PUB feosal eliair 2.5 il daily NONE Hydrocephalus (has shunt) (Encephalomalacia) TX01119 1
0174872 09/04/2001 DE 55.0 55 F I had a reaction the the third injection. Soon after my first 2 injections of Lymerix I started having leg and joint pain. I now have arthritic pain all over my body. I cannot carry or lift anything of weight. There are days I need to help to get out of bed. I need MS Contin for pain. I will never be able to work again. I have vision problems and nausea and weakness. The annual follow up states "I am still the same-MD put me on Prednisone which has helped. Without Prednisone and MSContin-Cr, I cannot handle the pain and to move my body without these medications. Y N 03/02/1999 07/09/1999 129 HDL DR4 came back positive. I went to Dr., infections disease. PVT PVT Hypertension, Diabetes 1
0174873 09/04/2001 AR 1.5 1 .5 F 08/22/2001 Fever X 72 Hrs > 102 F at vaccine site -> 4-5 cm area of enthema, L thigh swelling, limp - lasting 12 hrs X lmp . 72 hrs Y 08/24/2001 08/25/2001 1 NONE PVT PVT NONE NONE NONE 1
0174874 09/04/2001 WA 0.7 0 .7 M 08/14/2001 where prevnar immunization given, area got very swolledn, red - larger than quater size, fever 100.3. could hardly walk, swelling slasing going down- redness gone but small lump still in area of thigh, baby still has lump on thigh and doctor does not think its important to see baby. baby is still having trouble walking N 08/03/2001 08/04/2001 1 PVT UNK 1
0174875 09/04/2001 WV 0.3 0 .3 F 08/31/2001 Pt was found in the bed red in the face and did not seem herself. She seemed to be short of breath and unable to swallow. Was brought to ER where blood sugar and blood gases were found to be normal and was warm to touch. Temperature was 98.3 by ear. Was sent to Morgantown for a EEG on 08/31/2001. Y Y 08/28/2001 08/28/2001 0 EEG on 8/31/01- no results reported. PUB PUB NONE NONE NONE 1
0174876 09/04/2001 MA 0.3 0 .4 F 08/31/2001 Received Dtap, Ipv, Hib, Prevnar 8-29-01 Developed fever to 103.6 R w/in 24 hrs some irritablility Y N 08/29/2001 08/30/2001 1 PVT PUB 1
0174909 09/04/2001 TX 4.0 4 M 08/14/2001 On 8/9/01, approx. 10:30, mother brought child to the district to look at his left arm. Arm was edematous and slightly reddened, warm to touch inferior to injection sites. Pt was referred to MD and mom transported child at that time and to treat as recommended by MD. Y Y 08/07/2001 08/08/2001 1 NONE OTH PUB NONE NONE NONE TX00122 1
0174910 09/04/2001 TX 11.0 11 F 08/15/2001 Vaccinated with Hep-A and B on 8/13/01. The pt woke up with rash, the day after vaccination. It was a small papular rash over the body. Referred to own MD. No other symptoms. Y 08/13/2001 08/14/2001 1 PUB PUB PPD/Aventis/C0631AA/LFA/1 previously NONE TX01118 1
0174911 09/04/2001 TX 4.0 4 M 08/02/2001 Mother of child, states that a couple of hours, post vax, site of injection turned red. It continued to enlarge in size. Today it is approx. 6" in diameter, hot to touch and very hard. Child complaining of pain upon touch. Called for missing info on 8/17/01 and again on 8/24/01. Y U 07/31/2001 07/31/2001 0 UNK UNK PPD/Connaught/C0579AA/ID/LA/1 previously NONE Allergy to sulfa TX01117 1
0174912 09/04/2001 VA 1.0 1 .0 F 08/15/2001 One week after receiving vaccines, this infant had 2 blisters, the 2nd week after the patient broke out all over. She had a temp of 101, that responded to Tylenol. The doctor also diagnosed with impetigo. Gave Cephalaxin and Bactroban cream. Y Y 07/25/2001 08/01/2001 7 PUB UNK NONE NONE VA01026 1
0174913 09/04/2001 CA 4.0 4 M 08/23/2001 Pt reacted with swollen and red left arm the next day. No fever. Came into office and was looked at. No medications. Y Y 08/20/2001 08/21/2001 1 PVT PVT NONE 1
0174914 09/04/2001 MO 2.0 2 .0 M 08/27/2001 Post vax, that evening, the pt developed a small red and hard area. On 8/26/01, redness was approx. 2" X 3", warm and tender. Parent treated with ice and Motrin. On 8/27/01, reports that redness is gone and only the hard knot remains. No fever and no fussiness. Y 08/24/2001 08/26/2001 2 PVT PVT NONE NONE 1
0174915 09/04/2001 TN 4.0 3 F 08/27/2001 On right thigh, site is inflammed and redness of 17cm diameter and induration of 12cm diameter at site of DTAP, immediately onset less than 24 hours, post vax. At 72 hours, post vax, it is resolving. Y 08/24/2001 08/25/2001 1 PVT OTH PPD/SC/LFA/1 previously NONE NONE 1
0174916 09/04/2001 NY 1.75 1 .8 F 08/23/2001 Pt developed a 10 x 6 cm area of erythema and induration on right thigh and a 4 x 2 area of erythema and induration on left thigh. Y Y 08/20/2001 08/21/2001 1 PVT PUB Low grade fever NONE 1
0174917 09/04/2001 CA 2.0 2 .1 F 08/24/2001 Pt had swelling and red area on right arm. 08/21/2001 08/22/2001 1 NONE PVT PUB NONE NONE NONE 1
0174918 09/04/2001 AZ 4.0 4 F 08/23/2001 Pt developed an 8 cm area of erythema, swelling and tenderness on left deltoid region. Y 08/21/2001 08/23/2001 2 NONE PVT PUB NONE NONE 1
0174919 09/04/2001 NV 42.0 42 F 08/28/2001 Pt c/o developing temp of 104, hives on scalp and puffy eyelids within 3 hours of receiving vax. Y 08/22/2001 08/22/2001 0 NONE PUB PVT NONE NONE NONE Hives~Td Adsorbed (no brand name)~~0.00~In Patient 1
0174920 09/04/2001 TX 4.0 4 F 08/27/2001 Pt had a local reaction consisting of redness and swelling on right leg 4-5". Y 08/20/2001 08/21/2001 1 PVT PVT Claritin Tubes in ears, allergies 1
0174921 09/04/2001 CA 43.0 43 F The first day pt had flu-like symptoms, body aches, diarrhea, and vomiting. The second day she felt better yet weak. The third day she had a fever of 102, body aches, nausea, hands had tingly feeling. On the fourth day, nausea persisted, she had loss of appetite and weakness. On the fifth day, bouts of nausea were lessening, she had intermittent diarrhea but not as bad as the first day. As of 8/16/01, she was slightly nauseated. Y 07/24/2001 08/01/2001 8 OTH PUB NONE Penicillin allergy 1
0174922 09/04/2001 IA 1.25 1 .3 M 08/24/2001 At site of Comvax, pt developed redness, induration and warmth measuring 23mm x 12mm. Y 08/09/2001 08/10/2001 1 PVT PVT NONE 1
0174923 09/04/2001 CA 5.0 5 M 08/23/2001 Pt developed swelling, erythema and mild tenderness over 3 days. He was treated with Benadryl. U 08/21/2001 08/22/2001 1 NONE PVT PVT NONE NONE NONE 1
0174924 09/04/2001 TX 1.6 1 .6 M 08/23/2001 Pt developed some swelling and redness on upper thigh area (4.5cm). He was treated with ice. Call back to mother on 8/24/01 revealed pt doing fine. Y 08/20/2001 08/23/2001 3 NONE PUB UNK NONE NONE 1
0174925 09/04/2001 MO 4.0 4 F 08/27/2001 Pt's mother stated pt threw up approximately 12 hrs post vax. She had no further problems. Y 08/20/2001 08/21/2001 1 NONE PVT PUB NONE NONE NONE 1
0174926 09/04/2001 MI 47.0 47 F 08/23/2001 Pt noted itching and swelling on 8/22/01. She used ice since vax on 8/21/01. Left upper arm was very swollen (twice the size of other upper arm), red and warm from top of shoulder to elbow laterally. 08/21/2001 08/22/2001 1 NONE PVT OTH NONE Laceration on left leg NONE 1
0174927 09/04/2001 FL 4.0 4 F 08/31/2001 Twenty four hours post vax, pt developed swelling and erythema measuring 11 x 7.8 cm. At 36 hours, the swelling and erythema had increased to 20 x 11 cm. She was treated with oral diphenhydramine. 08/27/2001 08/28/2001 1 PVT PVT NONE Atopic dermatitis 1
0174934 09/05/2001 31.0 31 M 08/29/2001 After this patient received Hep A immunization approximately 1 hour later returned complaining of slight difficulty in breathing and throat tightening. Patient given Benadryl with good results. Y Y 08/29/2001 08/29/2001 0 UNK UNK hx of sewage exposure 1
0174935 09/05/2001 IA 1.0 0 1 F 08/28/2001 After vaccinated, symptoms were bruising easily, irritable, mood swings, crying, sleeplessness, change of personality from happy quiet child to irrational wild like behavior. Diagnosed 08/12/97 with ITP (idiopathic thrombocytopenic purpura) - low platelets at chronic low, bruising, petechia under 20,000. Treatments have ranged from prednisone multiple times, IVIG multiple (20) times, methylprednisolone (5x) no effect. Y Y Y 1 Y N 10/18/1994 08/08/1997 1025 CBC tests, Bone Marrow Aspiration 10/99, shows only chronic ITP. PUB PUB Tylenol NONE 1
0174936 09/05/2001 NY 12.0 12 F 09/01/2001 Three days after Hep B vaccine #2 (1st vaccine 1 year earlier) fever of 104, headache, seizure. Diagnosed with viral meningo-encephalitis. The discharge summary states encephalopathy. Y Y Y 14 Y 08/03/2001 08/06/2001 3 Spinal Tap, MRI. PVT PVT NONE NONE NONE 1
0174938 09/05/2001 CA 7.0 M This patient had cellulitis at the injection site from administration of pneumococcal vaccine Prevnar. Required antibiotics to treat the cellulitis. 01/31/2001 UNK UNK 1
0174940 09/05/2001 VA U 02/21/2001 Within 24 hours of vax, pt developed a "severe" injection site reaction characterized by swelling, redness and tenderness. No further info was available at date of this report. Manufacturer's Comment: The reporter indicated that 5 pts experienced this event; howeer, they are not presently identifiable. Addtl reports will be generated when identifying info is provided. U UNK PVT OTH UNK NONE UNK HQ4634808DEC2000 1
0174941 09/05/2001 AL 37.0 37 M 06/29/2001 The day following vax pt developed a fever of 102F and an injection site reaction at the site of Pnu-Imune-23 administration which the reporter did not describe. On 12/7/00 pt was seen by MD and treated with Motrin, Benadryl, Tylenol and applications of cold compresses. A copy of this report has been forwarded to Aventis Pasteur Inc., manufacturer of Fluzone. Follow-up info recvd 6/18/01 indicated that the pt received Pnu-Imune 23 on 12/6/00. He recovered. Y 12/06/2000 12/06/2000 0 UNK PVT OTH Allergens NONE UNK HQ4720111DEC2000 1
0174942 09/05/2001 IL 66.0 66 F 12/20/2000 A nurse reported that pt received pneumococcal (manufacturer unk) and 1993-94 formula influenza (manufacturer unk) vaccines in 1993 and subsequently developed an injection site reaction characterized by redness and soreness. She recovered. Y 07/01/1993 07/01/1993 0 UNK OTH OTH UNK UNK UNK HQ3065401NOV2000 1
0174943 09/05/2001 AR 67.0 67 U 02/09/2001 Two days post vax the pt developed an injection site reaction at the Pnu-Imune 23 site described as "a large red wheal 3 inches in diameter that became sore radiating down to the elbow." Note: This is 1 of 2 pts reported by the same reporter. See HQ6352724JAN2001 for the report on the other pt. U 01/20/2001 01/22/2001 2 UNK OTH OTH Prilosec NONE UNK HQ6999308FEB2001 1
0174944 09/05/2001 PA 88.0 88 F 03/21/2001 Two days post vax pt developed an injection site reaction characterized by redness, pain, swelling and itching at the site of Pnu-Imune 23 administration. The MD instructed pt to treat with Motrin and applications of ice. That same day she was seen in ER and treated with an unspecified antibiotic. On 11/2/00, pt was seen by MD who noted "some" improvement of her symptoms. The pt had previously recvd an injection of Pnu-Imune 23 in 1993. This is 1 of 4 pts from this facility who experienced an adverse event following receipt of 2 different lots of Pnu-Imune 23. Follow-up info recvd from MD on 3/20/01 indicated the pt recovered. Y Y 10/26/2000 10/28/2000 2 UNK PVT OTH ASA, Lanoxin, Levoxyl, Miacalcin, vitamins NONE UNK HQ7135212FEB2001 1
0174945 09/05/2001 TX 65.0 65 F 02/12/2001 A nurse reported that a 65 year old female received an injection of Pnu-Imune 23 and Fluzone (Aventis Pasteur Inc.) vaccines on 11/13/00. Within 24 hours of vaccine administration, the patient developed an injection site reaction characterized by redness and swelling. The specific sites of vaccine administration were not reported. This is 1 of 2 patients from this facility who experienced an adverse reaction following receipt of Pnu-Imune 23 lot 469-133. U 11/13/2000 11/14/2000 1 UNK PUB OTH UNK UNK HQ6774702FEB2001 1
0174946 09/05/2001 NY 72.0 72 F 03/21/2001 A nurse reported that a 72 year old female received an injection of Pnu-Imune 23 and Influenza virus vaccine (manufacturer unknown) on 11/03/00. Subsequently,the patient developed cellulitis at the site of Pnu-Imune 23 administration. She was treated with Advil , Benadryl, and applications of warm compresses. This is 1 of 3 patients from this facility who developed an injection site reaction following receipt of Pnu-Imune 23 lot 470-588. Follow-up info received from the physician on 03/14/01, indicated that the patient experienced the adverse event on 11/04/2000. She was seen by the physician and recovered. Y Y 11/03/2000 11/04/2000 1 UNK PVT OTH Hydrochlorothiazide, Premarin, Prinivil. NONE UNK HQ6540629JAN2001 1
0174947 09/05/2001 CA F 04/19/2001 A female reported that she received Pnu-Imune 23 and Influenzae virus vaccines on 12/02/00. That same day, she experienced a headache, feeling sick to the stomach, weakness, dizziness, and a stiff neck. She also experienced "severe" pain from her right shoulder extending down her hand and up to the side of her neck to her skull. In addition, her hand became "purple in color" and she developed an injection site reaction characterized by redness and warmth at the site of Pnu-Imune 23 administration. She was seen by a physician who reportedly attributed the events to a reaction to the Pnu-Imune 23 injection. U 12/02/2000 12/02/2000 0 UNK OTH OTH UNK NONE UNK HQ4797513DEC2000 1
0174948 09/05/2001 NJ 57.0 57 F 01/25/2001 A 57 year old female received Pnu-Imune 23 and Flu-Shield (2000- 2001 Formula) on 12/12/00. The next day, she developed an injection site reaction characterized by redness, swelling, and tenderness below the Pnu-Imune 23 injection site. U 12/12/2000 12/13/2000 1 UNK PVT PVT NONE NONE UNK HQ4932515DEC2000 1
0174949 09/05/2001 GA 43.0 43 F 05/03/2001 A 43 year old female reported that she received Pnu-Imune 23 and Influenza virus vaccine (manufacturer unknown) on 12/14/00. Within "a few hours" of vaccine administration, she developed an injection site reaction characterized by a "large" hive that swelled to the size of a "baseball", itching, and redness. The reporter indicated that both vaccines were administered in the left deltoid. U 12/14/2000 12/14/2000 0 UNK PVT OTH Allegra, Desogen "Ciba-Geigy", Detrol, Inderal, Prozac, Trazodone. NONE UNK HQ5024519DEC2000 1
0174950 09/05/2001 UT 55.0 55 F 06/05/2001 A medical assistant reported that a 55 year old female received an injection of Pnu-Imune 23 on 01/04/01. The following day, she developed an injection site reaction characterized by tenderness, swelling, redness, and warmth. She was treated with Benadryl and applications of moist heat. The patient recovered by 01/09/01. This is 1 of 2 patients from this facility who experienced this event following receipt of Pnu-Imune 23 lot 466-440. Follow-up info received from the physician on 05/29/01, indicated that the patient received Pnu-Imune 23 and Fluzone vaccines on 01/04/2001. The patient developed the injection site reaction at the site of Pnu-Imune 23 administration. Y 01/04/2001 01/05/2001 1 UNK PVT PVT Ogen, Provera NONE UNK HQ5885112JAN2001 1
0174951 09/05/2001 AR U 02/09/2001 A pharmacist reported that a pt (age and gender unspecified) received injections of Pnu-Imune 23 and Flu Shield (2000-2001 Formula) on 1/19/01. On an unspecified date, the pt developed an injection site reaction at the Pnu-Imune 23 site described as "a large red wheal, 3" in diameter that became sore, radiating down to the elbow". Note: This is 1 of 2 pts reported by the same reporter. See HQ6999308FEB2001 for the report on the other pt. U 01/19/2001 UNK OTH OTH Allegra, Premarin, Synthroid NONE UNK HQ6352724JAN2001 1
0174952 09/05/2001 DC 43.0 42 M 04/12/2001 A physician reported that a male pt received an injection of Pnu-Imune 23 and subsequently, developed tachycardia and a fever of 99.8F. He also developed an injection site reaction characterized by swelling and warmth. His blood pressure was 112/74. Follow-up information received from the physician on 4/3/01, indicated that a 43 year old male received Pnu-Imune 23 and Fluvirin (Evans) vaccines on 12/5/00. The following day, he developed tachycardia, fever and an injection site reaction at the site of Pnu-Imune 23 administration. The pt recovered. Y 12/05/2000 12/06/2000 1 NONE PVT OTH Albuterol, Allegra, Trazodone, Wellbutrin UNK Anaphylactic reaction; Urticaria NOS HQ4658308DEC2000 1
0174953 09/05/2001 AL 70.0 70 F 04/17/2001 A physician reported that a 70 year old female received Pnu-Imune 23 and Fluzone vaccines on 11/13/00. A "few" minutes, post vax, the pt developed arthritis type symptoms described as arthralgia and myalgia of both arms and effusion of her right shoulder. On 11/17/00, she was seen by the physician who "tapped" her shoulder and treated her with ibuprofen and Tylenol. The reporter stated that blood work showed an elevated ANA and "some of her CBC was abnormal". The reporter also indicated that this was a new pt and blood levels "could have been elevated prior to vaccination". This is 1 of 2 pts from this facility who had an adverse experience following receipt of Pnu-Imune 23 (lot 466786). U 11/13/2000 11/13/2000 0 ANA-elevated; Full blood count-abn PVT OTH Acetylsalicyclic acid, calcium, Levothyroxine, Prempro, Tylenol, Verapamil, Vitamins NONE UNK HQ4718711DEC2000 1
0174954 09/05/2001 TX 63.0 63 F 02/12/2001 A nurse reported that a 63 year old female received Pnu-Imune 23 and Fluzone vaccines on 11/13/00. Within 24 hours, post vax, the pt developed vomiting, general myalgia and alternating feelings of hot and cold. She also developed an injection site reaction characterized by redness and swelling. The specific sites of vaccine administration, were not specified. This is 1 of 2 pts from this facility who had an adverse experience following receipt of Pnu-Imune 23 (lot 469133). U 11/13/2000 11/14/2000 1 UNK PUB OTH UNK UNK Multiple Sclerosis HQ3945120NOV2000 1
0174955 09/05/2001 CO 79.0 F 01/30/2001 A nurse reported that a 79 year old female received Pnu-Imune 23 and Fluzone vaccines on 10/26/00. The following day, she developed pain, swelling and redness of her joints. The pt was dx'd with polyarthritis. U 10/26/2000 10/27/2000 1 UNK PVT PVT Premarin, Synthroid, Voltaren, Zoloft UNK UNK HQ3356708NOV2000 1
0174956 09/05/2001 NY 72.0 F 03/21/2001 A nurse reported that a 72 year old pt received an injection of Pnu-Imune 23 and influenza virus vaccine on 11/1/00. Subsequently, the pt developed cellulitis at the site of Pnu-Imune 23 administration. The pt was treated with an unspecified antibiotic. This is 1 of 3 pts from this facility who developed an injection site reaction following receipt of Pnu-Imune 23 (lot 470588). Follow-up information received from the physician on 3/14/01, indicated that a 72 year old female developed the adverse event on 11/2/00. She was seen by the physician and recovered. Y Y PVT OTH Altace, Vioxx, Xanax, Zyrtec NONE UNK HQ3380208NOV2000 1
0174957 09/05/2001 OH 75.0 75 M 02/08/2001 A nurse reported that a 75 year old male received Pnu-Imune 23 and Fluvirin vaccines on 10/24/00. The reporter stated that the vaccines were administered after being mixed in the same syringe. Approx. 6 hours later, the pt developed a fever, nausea and swelling at the injection site. He recovered by 10/27/00. Y 10/24/2000 10/24/2000 0 UNK OTH OTH NONE UNK UNK HQ3696214NOV2000 1
0174958 09/05/2001 VA M 02/07/2000 A physician reported that a male pt received Pnu-Imune 23 and 1999-2000 formula influenza virus vaccines on 10/19/99. On 10/20/99, he developed cellulitis and was seen in the physician's office. He was prescribed an unspecified antibiotic. This is 1 of 2 pts from this facility who experienced this event following receipt of Pnu-Imune 23 (lot 459040); the other was serious. See related MCN HQ3303122OCT1999. Additional information received from the physician on 12/7/99, indicated that the pt recovered. Y Y 10/19/1999 10/20/1999 1 UNK PVT OTH NONE NONE UNK HQ3303322OCT1999 1
0174959 09/05/2001 RI 58.0 58 F 05/10/2002 A 58 year old female received an injection of influenza virus vaccine in 10/76. One year, post vax, she developed hypersensitivity to the following; sulfa products, penicillin, Floxin, Cipro, codeine, clindamycin, Macrobid, generic Klonopin, blue dye, red dye #40, yellow dye FC #5 and #6, eggs, beef, bacitracin, proparacaine, lidocaine, Tobrex, fluoracaine, Acular, Ocuflox, Vexol and chlorine in the drinking water. Her hypersensitivity symptoms include: nausea and diarrhea. FOLLOW-UP information received fromthe patient on 08/27/01, indicated that she also developed a hypersensitivity to Bactorban and band-aids glue. FOLLOW-UP informationreceived from the patient on 05/09/02 indicated that her symptoms have not related. U 10/01/1976 10/01/1977 365 UNK PUB PUB Klonopin, Lopressor NONE Mastectomy NOS HQ2638128JUN2001 1
0174960 09/05/2001 VA 10.0 10 M 09/04/2001 Macular rash both forearms with a small amount on chest and face. Y Y 08/28/2001 08/30/2001 2 PVT PVT NONE NONE 1
0174961 09/05/2001 NH 5.0 4 F 08/09/2001 5" diameter red area at the site of injection. Y Y 08/07/2001 08/07/2001 0 NONE PVT PUB NONE NONE Allergy to sulfa drugs; causes a rash. NH0120 1
0174962 09/05/2001 NC 32.0 F 03/21/2001 A physician's assistant reported that a 32 year old female inadvertently received an intradermal injection of Pnu-Imune 23 on 8/14/00. Within 24 hours, she developed an injection site reaction characterized by a 12" X 4" area of redness, tenderness and swelling. She also had "severe" muscle pain in and around the area of erythema. U 08/14/2000 08/14/2000 0 UNK PVT OTH NONE NONE UNK HQ0044721AUG2000 1
0174963 09/05/2001 TX 72.0 72 F 03/16/2001 A daughter reported that her 72 year old mother received an injection of Pnu-Imune 23 on 8/21/00. Later that day, she developed an injection site reaction characterized by swelling and "severe" pain. She also developed a headache, malaise and generalized pain. Additional information received from the physician on 10/16/00, indicated that the pt did not report this to the physician's office. U 08/21/2000 08/21/2000 0 UNK PVT OTH Warfarin NONE Primary pulmonary hypertension HQ0242324AUG2000 1
0174964 09/05/2001 WI 8.0 8 M 12/27/2000 An 8 year old male received an injection of Pnu-Imune 23 and meningococcal vaccines, each in different arms, on 2/18/00 and subsequently, developed chills, nausea and an injection site reaction at the Pnu-Imune 23 administration site characterized by a 1 3/4" X 1 1/2" area of erythema and pain. He was treated with acetaminophen and cortisone cream. His temperature was 99F.. Additional information received on 10/30/00, indicated that the pt was seen by a physician and recovered. Y Y 02/18/2000 02/19/2000 1 UNK PVT OTH Amoxicillin, Septra UNK Bilateral occipital lobe hemorrhage NOS; Homonymous hemianopia NOS; Acute Severe Idiopathic thrombocytopenic purpura; Platelet count decreased but by 2/00 his platelet count was 270,000; Splenectomy HQ0366428AUG2000 1
0174965 09/05/2001 NH M 06/01/2001 A nurse reported that a 53 year old male received 23-valent pneumococcal vaccine and "is not responding". Additional information received on 5/23/01, indicated that the pt has a history of IgG deficiency and "did not make an immune response" following receipt of 23-valent pneumococcal vaccine on 4/01 with his 1st dose. See HQ0004423APR2001. U Antibody NOS-abn-pneumococcal titers indicated that the pt did not make an immune response OTH OTH UNK UNK Blood immunoglobulin G decreased HQ0478103MAY2001 1
0174967 09/05/2001 FL 66.0 66 F 05/15/2001 A healthcare professional reported that a 66 year old female received Pnu-Imune 23 on 5/3/01. Within hours, post vax, the pt developed an injection site reaction characterized by "severe" swelling, redness and pain from her shoulder to her fingertips. The pt was treated with applications of warm compresses. This is 1 of 2 pts from this facility who experienced this event, post vax, of Pnu-Imune 23 (lot 475387). U 05/03/2001 05/03/2001 0 UNK PVT OTH Fosamax, Lipitor and Vitamins NOS NONE UNK HQ0572207MAY2001 1
0174968 09/05/2001 TN 11.0 F 03/21/2001 A pharmacist reported that an 11 year old female received Pnu-Imune 23, MMRII and Hep-B vaccines on 8/25/00 and subsequently, developed a fever and an injection site reaction characterized by redness and tenderness. She recovered. This is 1 of 2 pts from this facility who experienced this event following receipt of Pnu-Imune 23 (lot 463729). Y 08/25/2000 UNK PVT OTH UNK NONE UNK HQ0586101SEP2000 1
0174969 09/05/2001 FL 77.0 77 F 05/15/2001 A healthcare professional reported that a 77 year old female received Pnu-Imune 23 on 4/25/01 and subsequently, developed an injection site reaction characterized by "severe" swelling, redness and pain from her shoulder to her fingertips for several days. The pt was treated with applications of warm compresses. This is 1 of 2 pts from this facility who experienced this event following receipt of Pnu-Imune 23 (lot 475387). U 04/25/2001 UNK PVT OTH Premarin, Fosamax and Hyzaar NONE UNK HQ0700109MAY2001 1
0174970 09/05/2001 TN 11.0 F 03/21/2001 A pharmacist reported that an 11 year old female received Pnu-Imune 23 and PROHIBIT vaccines on 8/24/00 and subsequently, developed a fever and an injection site reaction characterized by redness and tenderness. She recovered. This is 1 of 2 pts from this facility who experienced this event following receipt of Pnu-Imune 23 (lot 463729). Y 08/24/2000 UNK PVT OTH UNK NONE UNK HQ0776308SEP2000 1
0174971 09/05/2001 NJ 3.0 3 M 07/12/2001 A pharmacist reported that her 3 year old son received 23-valent pneumococcal vaccine on 5/8/01. That evening, the child developed a "low grade" fever of 100F-101F, as well as, pain at the injection site. By the evening of 5/9/01, the child had a fever of 104F with swollen glands. He was treated with Tylenol and Motrin. On 5/10/01, the child was seen by the physician and was subsequently, treated with Augmentin. An unspecified strep culture, taken the same day, was reportedly negative. As of 5/11/01, the injection site pain had resolved, but the fever and swollen glands persisted. The reporter indicated that the child had a cold a "few weeks ago" and that his glands were "slightly" swollen prior to vaccination. Follow-up information received from the reporter on 7/2/01, indicated that a "blood test" for Epstein-Barr virus was positive. The reporter considered the event to be unrelated to 23-valent pneumococcal vaccine administration. Y U 05/08/2001 05/08/2001 0 5/10/01-strep culture-neg; Blood test for Epstein-Barr virus was (+). PVT OTH NONE "slightly swollen glands" Nasopharyngitis HQ0836214MAY2001 1
0174972 09/05/2001 RI 61.0 60 F 06/06/2001 A 64 year old female reported that she received a dose of pneumococcal vaccine in 1998 at the age of 61. She indicated that, the year following receipt of the vaccine, she developed a pneumococcal infection. She reported a chronic history of pneumonia, bronchiectasis, earaches and various respiratory infections. These illnesses developed after previous pneumococcal immunizations. No further information was available at the date of the report. Y 01/01/1998 01/01/1999 365 UNK OTH OTH Valium UNK Bronchiectasis NOS; earache; pneumonia NOS; URI NOS; blood cholesterol; TIA HQ0976217MAY2001 1
0174973 09/05/2001 CA F 12/06/2000 A physician reported that a female in her late 70's received an injection of Pnu-Imune 23 on 04/19/00. Immediately post-vaccination, she developed an injection site reaction characterized by swelling, pain , and redness. This is 1 of 2 patients from this facility who experienced this event following receipt of Pnu-Imune 23 lot 458-744. U 04/19/2000 04/19/2000 0 OTH OTH UNK UNK HQ1072815SEP2000 1
0174974 09/05/2001 TX 11.0 11 F 06/27/2001 A nurse reported that an 11.5 year old female with a medical history of asthma received an injection of Pnu-Imune 23 on 05/14/01. That same day, she developed an injection site reaction characterized by left leg stiffness and swelling. On 05/15/01, the patient developed a red rash the size of a small dinner plate, swelling and tenderness at the injection site. She was seen by the physician that day and a diagnosis of cellulitis was made. She was treated with Cephalexin for 10 days. This is 1 of 2 patients from this facility who experienced cellulitis following experienced this event following receipt of Pnu-Imune 23 lot 463-748.The patient recovered. Y Y 05/14/2001 05/14/2001 0 UNK PVT PVT Nasonex, Singulair, Ventolin. UNK Asthma HQ1107321MAY2001 1
0174975 09/05/2001 TX 66.0 66 M 07/11/2001 A healthcare professional reported that a 66 year old male received an injection of Pnu-Imune 23 on 01/22/01. The same day, the patient developed an injection site reaction characterized by swelling, redness, and warmth which extended to his hand. The patient was treated with applications of warm compresses, which reportedly did not relieve his symptoms. On 01/25/01, he was prescribed Medrol Dosepak. This is 1 of 2 patients from this facility who developed an injection site reaction following receipt of Pnu-Imune 23 lot 469-132. Y 01/22/2001 01/22/2001 0 No tests performed. PVT PVT Aspirin, Cardizem, Combivent, Glipizide, Glucophage, Hydrocodone. Lasix, Naproxen, Pravachol, Prevacid, Terazosin, Zostrix NONE UNK HQ1124121MAY2001 1
0174976 09/05/2001 CA 81.0 81 F 12/15/2000 A physician reported that an 81 year old female received an injection of Pnu-Imune 23 on 4/19/00. Immediately, post vax, she developed an injection site reaction characterized by redness, pain and swelling. This is 1 of 2 pts from this facility, who experienced this event following receipt of Pnu-Imune 23, lot 458744. U 04/19/2000 04/19/2000 0 NONE OTH OTH Plain Timoptic; Calcium; Multivitamins NONE Glaucoma NOS HQ1172219SEP2000 1
0174977 09/05/2001 PA 85.0 85 M 07/25/2001 A nurse reported that an 85 year old male received his 2nd dose of Pnu-Imune 23 on 4/3/01. Within 48 hours, he developed an injection site reaction characterized by redness and swelling which extended to his elbow. The pt was treated "symptomatically" and he recovered. No further information was available at the date of this report. MANUFACTURER'S COMMENT: This is 1 of 2 pts from this facility who developed an injection site reaction following receipt of Pnu-Imune 23, lot 470592. See related HQ9390306APR2001. FOLLOW-UP information was received from the nurse on 07/13/01. The reporter indicated that the patient was unable to sleep for two night due to discomfort.the reporter noted that a third patient from this facility developed an injection site reaction following receipt of Pnu-imune 23, lot number 470-592. See related case HQ3493419JUL2001. Y 04/03/2001 04/04/2001 1 NONE PVT PVT Acetylsalicyclic acid; Zantac NONE Concurrent conditions: Prostatic Hyperplasia, Hyperpidemia, Hypertension HQ1201422MAY2001 1
0174978 09/05/2001 NM 78.0 78 F 05/30/2001 A nurse reported that a 78 year old female received an injection of Pnu-Imune 23 on 4/4/01 and subsequently, developed an injection site reaction characterized by redness, warmth, swelling and itchiness that extended from her deltoid to her forearm. The pt returned to the physician's office, 2 hours, post vax, and was treated with Benadryl. The redness, swelling and itchiness resolved. As of 4/12/01, a "small warm area" at the site of Pnu-Imune 23 administration persisted. This is 1 of 2 pts from this facility who developed an injection site reaction following receipt of Pnu-Imune 23, lot 474936. Y U 04/04/2001 04/04/2001 0 UNK PVT OTH Glyburide; Metformin NONE Diabetes mellitus NOS HQ1295024MAY2001 1
0174979 09/05/2001 FL U 06/06/2001 A pharmacist reported that a pt received an injection of Pnu-Imune 23 on 5/22/01 and subsequently, developed an injection site reaction characterized by redness, warmth and swelling. The reporter indicated that 2 pts experienced this reaction following receipt of Pnu-Imune 23 vaccine, lot 468147. Additional reports will be generated when identifying information is received. No further information was available at the date of this report. U 05/22/2001 05/22/2001 0 UNK PVT OTH UNK UNK UNK HQ1398929MAY2001 1
0174980 09/05/2001 TX 70.0 69 M 05/31/2001 A nurse reported that a 70 year old male received an injection of Pnu-Imune 23 on 5/23/01. On 5/24/01, he developed an injection site reaction characterized by redness, swelling and heat. This is 1 of 2 pts from this facility who experienced this event following receipt of Pnu-Imune 23, lot 472209. U 05/23/2001 05/24/2001 1 UNK PVT PVT Vasotec, Acetylsalicylic Acid, Prevacid NONE UNK HQ1488631MAY2001 1
0174981 09/05/2001 TX 42.0 42 F 05/31/2001 A nurse reported that a 42 year old female received an injection of Pnu-Imune 23 on 4/20/01. On 4/21/01, she developed an injection site reaction characterized by redness, swelling and heat. This is 1 of 2 pts from this facility who experienced this event following receipt of Pnu-Imune 23, lot 472209. U 04/20/2001 04/21/2001 1 UNK PVT PVT E-Vista NONE UNK HQ1492131MAY2001 1
0174982 09/05/2001 NH 41.0 41 F 06/22/2001 On 5/20/01, pt developed swollen joints, facial flushing and itching of the hands and feet. She was seen in the ER. Additional information recvd from MD on 6/19/01 indicated that the pt was treated with prednisone tapered over 2 wks and diphenhydramine. She recovered. Y Y 05/17/2001 05/20/2001 3 WBC 4.7, HGB 11.4, HCT 32.5, ESR 49, blood urea 17, blood creatinine 0.8, blood potassium 4.0, blood sodium 140, blood bicarbonate 27, alanine aminotransferase 42, aspartane aminotransferase 20, blood alkaline phosphatase 82, blood bilirubin 0.3, bilirubin conjugated 0.1 OTH OTH Glucophage NONE NIDDM, eczema HQ1620104JUN2001 1
0174983 09/05/2001 NC 45.0 45 F 03/09/2001 A nurse reported that a 45 year old female received an injection of Pnu-Imune 23 on 98/18/00. On 09/20/00, she developed nausea, vomiting and numbness in her chest and stomach. Her symptoms resolved prior to being seen by the physician on 10/02/00. Additional info received on 11/15/00 indicated that the patient was allergic to x-ray dye, nitrofurantoin, sulfa, aspirin, hydrocodone / acetaminiphen, oxycodone / acetaminophen and troglitazone. Y Y 09/18/2000 09/20/2000 2 UNK PVT OTH Albuterol, Amitriptyline, Dipivefrine Hydrochloide. UNK Contrast media reaction; drug hypersensitivity. 173930 1
0174984 09/05/2001 PA 43.0 F 12/27/2000 Approximately 24 hours post vax, pt developed an injection site reaction characterized by redness and induration. The pt also developed a fever of 101F that lasted for 1-2 days, then a fever of 99-100F. She also experienced malaise, shortness of breath, a choking sensation and chest tightness. The reporter stated that the injection site reaction had resolved, but the other events are "ongoing to a lesser degree." The MD noted that these events "may be related" to an injection of MMR that the pt recvd 1 wk earlier. A copy of this report has been forwarded to Merck, manufacturer of MMR. U 09/06/2000 09/07/2000 1 PVT OTH NONE NONE Herpes simplex HQ1768204OCT2000 1
0174985 09/05/2001 IN 33.0 32 M 06/07/2001 A nurse reported that a 33 year old male received Pnu-Imune 23 and Hep-A vaccines on 4/4/01. Later that evening, he developed an injection site reaction characterized by a 30mm area of redness and induration and inability to move his arm. He also experienced nausea and vomiting and developed a fever of 101F. The symptoms lasted about 2 days. No further information was available at the date of this report. The reporter indicated that 4 pts experienced these events following receipt of Pnu-Imune 23, lot 469401. (See HQ9560211APR2001, HQ1777407JUN2001 and HQ1777507JUN2001). Y 04/04/2001 04/04/2001 0 UNK PVT PVT NONE NONE UNK HQ1777307JUN2001 1
0174986 09/05/2001 IN 40.0 F 06/07/2001 A nurse reported that a 40 year old female received an injection of Pnu-Imune 23 on 4/6/01. That same day, she developed an injection site reaction characterized by a 30mm area of redness and induration and inability to move her arm. She experienced nausea and vomiting and developed a fever of 101F. She recovered. No further information was available at the date of the report. This is 1 of 4 pts from this facility who experienced these events following receipt of Pnu-Imune 23, lot 469401. (See HQ9560211APR2001, HQ1777307JUN2001 and HQ1777507JUN2001). Y 04/06/2001 04/06/2001 0 UNK PVT PVT UNK NONE UNK HQ1777407JUN2001 1
0174987 09/05/2001 IN F 06/08/2001 A nurse reported that a female, approx. 26-27 years of age, received an injection of Pnu-Imune 23 (date not specified). Within hours, post vax, she developed an injection site reaction characterized by a 30mm area of redness and induration and inability to move her arm. She experienced nausea and vomiting and developed a fever of 101F. The symptoms resolved within a few days. No further information was available at the date of the report. The reporter indicated that 4 pts experienced these events following receipt of Pnu-Imune 23, lot 469401. (See HQ9560211APR2001, HQ1777307JUN2001 and HQ1777407JUN2001). Y UNK PVT PVT UNK NONE UNK HQ1777507JUN2001 1
0174988 09/05/2001 WV U 10/16/2000 A MA reported that a pt received an injection of Pnu-Imune 23 in 9/00. Subsequently, the pt developed an injection site reaction characterized by a "large" red, swollen area that was "hot to the touch". The swelling extended from shoulder to elbow. The pt recovered. The reporter indicated that 3 pts experienced this event; however, they are not presently identifiable. Additional reports will be generated when identifying information information is provided. Y 09/01/2000 UNK PVT OTH UNK NONE UNK HQ1876506OCT2000 1
0174989 09/05/2001 MA 1.5 U 03/09/2001 A pharmacist reported that an 18 month old child inadvertently, received an injection of Pnu-Imune 23. The next day, the child developed a minor fever. No further information was available at the date of this report. U UNK OTH OTH UNK UNK UNK HQ1956709OCT2000 1
0174990 09/05/2001 MA 62.0 62 F 10/18/2000 A nurse reported that a 62 year old female received an injection of Pnu-Imune 23 on 9/29/00. On 10/2/00, she was dx'd with cellulitis. The pt was treated with Keflex. The reporter indicated that 2 pt's experienced a "cellulitis reaction"; however, they are not presently identifiable. An additional report will be generated when identifying information is provided. U 09/29/2000 10/02/2000 3 UNK PVT PUB Erythromycin; Flovent; Salbutamol; Albuterol; Atenolol NONE UNK 958209 1
0174991 09/05/2001 MA 65.0 65 F 10/18/2000 A healthcare professional reported that a 65 year old female received an injection of Pnu-Imune 23 and Tetanus Toxoid vaccines on 7/19/00. The next day, the pt developed an injection site reaction at the site of the Pnu-Imune 23 administration. She was dx'd with cellulitis and treated with Rocephin and Keflex. This is 1 of 2 pts from this facility who experienced this event following receipt of Pnu-Imune 23, lot 462810. U 07/19/2000 07/20/2000 1 UNK PVT PVT Esgic; Zantac NONE UNK HQ1984410OCT2000 1
0174992 09/05/2001 CA 28.0 28 M 12/19/2000 A pharmacist reported that a 28 year old male received Pnu-Imune 23 and Hib-Titer vaccines on 10/1/00. The next day, he developed a severe headache and a fever of 102F. He also developed soreness at the injection site. On 10/3/00, the injection site reaction included a 6" X 3" area of warmth, redness and induration. The fever and headache resolved in 2 days. U 10/01/2000 10/03/2000 2 Direct Coombs test-neg PVT OTH Morphine; Tylenol; Vicodin; Cefoxitin; Colace UNK Leucocytosis NOS; Splenomegaly HQ1986410OCT2000 1
0174993 09/05/2001 PA 68.0 68 F 03/21/2001 A pharmacist reported that a female received an injection of Pnu-Imune 23 on 10/6/00 and subsequently, developed an injection site reaction characterized by pain, erythema and hardness. As of 10/13/00, the pain persisted. The reporter indicated that 2 females experienced this event; however, they are not presently identifiable. Additional reports will be generated when identifying information is provided. Additional information received from the physician's office on 11/20/00, indicated that the pt is a 68 year old female, immunized on 10/5/00. On 10/6/00, she developed a fever, enlarged axillary glands, itching, skin peeling and shoulder pain. She recovered. Y 10/05/2000 10/06/2000 1 UNK OTH OTH Coumadin; Lipitor; Premarin; Synthroid NONE UNK HQ2339417OCT2000 1
0174994 09/05/2001 MT 71.0 71 F 03/09/2001 A nurse reported that a 71 year old female received an injection of Pnu-Imune 23 on 10/2/00 and subsequently, developed an injection site reaction characterized by redness, swelling and itching. The pt's husband insists that his wife received Pnu-Imune 23, 1 year ago; however, the pt does not remember this. She recovered. Y 10/02/2000 UNK PVT PVT etodolac; Levoxyl; nadolol; Premarin; Colestyramine; Detrol Chest pain Diarrhea NOS; Hypothyroidism; Urinary frequency HQ2480419OCT2000 1
0174995 09/05/2001 PA 74.0 74 F 07/18/2001 A MA reported that a pt received a dose of Pnu-Imune 23 vaccine in 6/01 and subsequently, developed cellulitis. The pt was seen in the ER and was prescribed antibiotics. The pt recovered. The reporter indicated that 3 or 4 pts experienced this event following receipt of Pnu-Imune 23, lot 468147. (See HQ3428718JUL2001 and HQ3428818JUL2001). Y Y 06/01/2001 06/01/2001 0 UNK OTH OTH ASA, Atenolol, Avapro, Calcium, Xanax NONE Concurrent conditions: Atrial Fibrillations, bone Mass Decreased, Hypersensitivity NOS, Hypertension NOS HQ2484325JUN2001 1
0174996 09/05/2001 IL 73.0 73 F 03/21/2001 A nurse reported that a 73 year old female received an injection of Pnu-Imune 23 on 10/16/00 and subsequently developed an injection site reaction characterized by redness and soreness. On 10/17/00, the swelling, redness and pain was more severe, extending from slightly above the injection site down to her wrist and involving the hand. She was seen by the physician and treated with hydroxyzine and applications of cold compresses. Additional information received on 1/5/01, indicated that the pt recovered. Y Y 10/16/2000 10/16/2000 0 UNK PVT OTH Toprol XL; Capoten; Insulin NONE Diabetes Mellitus NOS Redness and soreness~Pneumo (no brand name)~1~66.00~In Patient HQ2545320OCT2000 1
0174997 09/05/2001 GA U 12/27/2000 A healthcare professional reported that a pt received an injection of Pnu-Imune 23 and subsequently developed an injection site reaction characterized by redness, swelling and warmth. No further information was available at the date of this report. The reporter indicated that 2 pts experienced this event; however, they are not presently identifiable. An additional report will be generated when identifying information is provided. U UNK PVT OTH NONE NONE UNK HQ2592721OCT2000 1
0174999 09/05/2001 WV 46.0 46 F 03/21/2001 A physician reported that a 46 year old pt received an injection of Pnu-Imune 23 on 9/29/00. On 9/30/00, the pt developed an injection site reaction characterized by redness, swelling and pain. Additional information received from the physician on 12/5/00, indicated that the pt recovered. Y Y 09/29/2000 09/30/2000 1 UNK PVT OTH Xanax; Claritin; Pamelor Sinusitis Depression NEC; Sinusitis NOS HQ2748325OCT2000 1
0175000 09/05/2001 WV M 10/31/2000 A healthcare professional reported that a male received an injection of Pnu-Imune 23 in 09/00. One day post-vaccination, the patient developed a fever and an "itchy rash on the back of his hands like a blister that pops and moves to different parts of the hand". A physician described this as a "pemphigoid rash". He was also found to have an increased LDL (lactic dehydrogenase level). U UNK OTH OTH UNK UNK UNK HQ2758125OCT2000 1
0175001 09/05/2001 WV 59.0 F 12/20/2000 A physician reported that a 59 year old female received an injection of Pnu-Imune 23. On 09/27/00, she developed an injection site reaction characterized by a large red welt, swelling, heat, and achiness. U 09/27/2000 UNK OTH OTH UNK UNK UNK HQ2802826OCT2000 1
0175002 09/05/2001 WV 57.0 F 12/20/2000 A physician reported that a 57 year old female received an injection of Pnu-Imune 23 on 9/26/00. The next day, the pt developed an injection site reaction characterized by a red welt, "covering her entire arm from shoulder to elbow", swelling, warmth and pain. She was seen by the physician. This is 1 of 2 pts from this facility who developed an injection site reaction following receipt of Pnu-Imune 23 lot 466788. Y U 09/25/2000 09/26/2000 1 UNK OTH OTH UNK UNK UNK HQ2803026OCT2000 1
0175003 09/05/2001 VT 41.0 41 F 12/27/2000 A physician reported that a 41 year old female received an inadvertent Intradermal injection of Pnu-Imune 23 in her forearm on 10/24/00. PPD was to have been administered. Within 24 hours, the pt experienced diarrhea. Additionally, she experienced total body discomfort, serum sickness symptoms and swelling at the injection site, described as a "quarter-size" local reaction. U 10/24/2000 10/24/2000 0 NONE PVT OTH Citalopram Depression Depression NEC HQ2870227OCT2000 1
0175004 09/05/2001 FL 79.0 79 F 01/25/2001 A MA reported that a 79 year old female received an injection of Pnu-Imune 23 on 10/17/00 and within a few hours, post vax, she developed an injection site reaction characterized by swelling, heat, redness and pain. It was also reported that this pt had received a dose of Pnu-Imune 23 in 1994. This is 1 of 3 pts from this facility who had an adverse experience following receipt of Pnu-Imune 23, lot 463015. U 10/17/2000 10/17/2000 0 UNK PVT PVT Calcium; Celexa; Fosamax; Premarin; Vitamins, Other combinations; Zocor NONE UNK HQ2922330OCT2000 1
0175005 09/05/2001 FL F 01/29/2001 A physician reported that his mother-in-law received an injection of pneumococcal vaccine and subsequently became "very ill". The reporter stated that she was told she was allergic to the vaccine. No further information was available at the date of this report. U UNK OTH OTH UNK UNK UNK HQ3310707NOV2000 1
0175006 09/05/2001 NY 83.0 82 F 04/06/2001 A physician reported that an 83 year old female received an injection of Pnu-Imune 23 on 11/7/00. That same day, she developed an injection site reaction characterized by redness and swelling. This is 1 of 3 pts from this facility who developed an injection site reaction following receipt of Pnu-Imune 23, lot 470588. Follow-up information received on 3/27/01, from the physician, indicated that the pt recovered. Y 11/07/2000 11/07/2000 0 UNK PVT OTH UNK NONE UNK HQ3410109NOV2000 1
0175007 09/05/2001 PA 75.0 75 M 07/18/2001 An MA reported that 75 year old male received a dose of Pnu-Imune 23 vaccine on 6/7/01. The next day, he developed an injection site reaction. He was seen in the ER and was prescribed antibiotics for cellulitis. The pt recovered. This is 1 of 3 pts from this facility who experienced this event following receipt of Pnu-Imune 23, lot 468147. (See HQ 2484325JUN2001 and HQ 3428818JUL2001). Y Y 06/07/2001 06/08/2001 1 UNK OTH OTH Claritin; Ecotrin; Enalapril; Lipitor; Plavix; Toprol XL NONE Hypertension NOS; Benign prostatic hyperplasia; Coronary artery surgery; Pulmonary granuloma NOS HQ3428718JUL2001 1
0175008 09/05/2001 PA 70.0 69 M 07/18/2001 An MA reported that a 70 year old male received a dose of Pnu-Imune 23 vaccine in 6/01. He subsequently, developed an injection site reaction. He was seen in the ER and prescribed antibiotics for cellulitis. He recovered. This is 1 of 3 pts from this facility who experienced this event following receipt of Pnu-Imune 23, lot 468147. (See HQ 2484325JUN2001 and HQ 3428718JUL2001). Y Y 06/01/2001 06/01/2001 0 UNK OTH OTH UNK NONE Blood cholesterol increased; hypertension NOS; Intervertebral disc degeneration NOS; Benign prostatic hyperplasia HQ3428818JUL2001 1
0175009 09/05/2001 CA 71.0 71 F 02/06/2001 A 71 year old female reported that she received an injection of Pnu-Imune 23 in 11/99. Subsequently, she developed a slight fever and an injection site reaction characterized by a 3.5" area of redness, burning and pain. The pt stated that the redness lasted for 3 months. She also stated that she still has a "mark" at the site of vaccine administration. Y 11/01/1999 UNK OTH OTH Cozaar; Synthroid UNK UNK HQ3536911NOV2000 1
0175010 09/05/2001 NH 30.0 M 04/17/2001 A nurse reported that a male in his 30's, dx'd with HIV, received an injection of Pnu-Imune 23 in 10/00. Approx. 3 weeks later, the pt's anergy panel test-PPD/with candida and mumps results were negative. The reporter indicated that the pt should have a positive result because of "his good immune system". U 10/01/2000 11/01/2000 31 UNK OTH OTH UNK HIV HIV infection NOS HQ3734215NOV2000 1
0175011 09/05/2001 MO 56.0 F 02/12/2001 A nurse reported that a 56 year old female received an injection of Pnu-Imune 23 on 11/16/00 and within hours, post vax, the pt developed an injection site reaction characterized by redness, pruritus and swelling which extended from the site of the injection to the elbow. She was treated with Atarax (hydroxyzine) and Medrol (methylprednisolone). This is 1 of 2 pts from this facility who developed an injection site reaction following receipt of Pnu-Imune 23, lot 474939. U 11/16/2000 11/16/2000 0 UNK OTH OTH UNK UNK UNK HQ3900720NOV2000 1
0175012 09/05/2001 MO 37.0 F 02/13/2001 A nurse reported that a 37 year old female received an injection of Pnu-Imune 23 on 11/16/00. Within hours, post vax, she developed an injection site reaction characterized by swelling, redness and a "softball-size" knot. The pt was treated with Atarax (hydroxyzine) and Medrol (methylprednisolone). This is 1 of 2 pts from this facility who developed an injection site reaction following receipt of Pnu-Imune 23, lot 474939. U 11/16/2000 11/16/2000 0 UNK OTH OTH UNK UNK UNK HQ3908920NOV2000 1
0175013 09/05/2001 NY U 02/12/2001 A pharmacist reported that a pt recvd Pnu-Immune-23 on 11/14/00. The following day, pt developed an injection site reaction characterized by a red, raised rash. No further info was available at the date of this report. Manufacturer's Comment: The reporter indicated that 40 to 50 pts experienced this event; however, they are not presently identifiable. Addtl reports will be generated when identifying info is provided. U 11/14/2000 11/15/2000 1 OTH PVT UNK UNK UNK HQ3930120NOV2000 1
0175014 09/05/2001 OH U 02/12/2001 A pharmacist reported that a pt received an injection of Pnu-Imune 23 and subsequently, developed an injection site reaction characterized by redness and swelling "the size of a golf ball". No further information was available at the date of this report. U UNK OTH OTH UNK UNK UNK HQ3988321NOV2000 1
0175015 09/05/2001 FL 2.0 U 05/25/2001 A pharmacist reported a 35 month old child (gender not specified) received an injection of Pnu-Imune 23 on 10/13/00. The child reported immunocompromised, but reporter "is unsure how". "Humoral immunity testing" showed the child only converted to serotypes 14, 19 and 23 but did not convert to serotypes 1, 3 and 51. The date and time of the humoral immunity testing was not specified and it was unclear whether the testing was done before or after vaccination. No further information was available at the date of this report. U 10/13/2001 UNK OTH OTH UNK UNK Immune System Disorder NOS HQ4168228NOV2000 1
0175016 09/05/2001 PA 77.0 77 M 03/21/2001 An MA reported that a 77 year old male received an injection of Pnu-Imune 23 on 11/14/00. The following day, he developed on injection site reaction characterized by redness and swelling. The reporter described this as a "cellulitis-like" reaction. He was seen by the physician and treated with Medrol (methylprednisolone), Tylenol (acetaminophen) and applications of ice. The pt had previously received an injection of Pnu-Imune 23 on 11/2/95. This is 1 of 4 pts from this facility who experienced an adverse reaction following receipt of 2 different lots of Pnu-Imune 23. Follow-up information received from the physician on 3/20/01, indicated that the pt recovered. Y Y 11/14/2000 11/15/2000 1 UNK PVT PVT Prevacid; Zocor; Colace; Flonase NONE UNK HQ4222129NOV2000 1
0175017 09/05/2001 KY U 02/13/2001 A healthcare professional reported that a pt received an injection of Pnu-Imune 23. Approx. 4 hours to 1 day, post vax, the pt developed an injection site reaction characterized by swelling, redness and pain. The symptoms resolved in 2 days. The reporter indicated that 4 pts experienced this event; however, they are not presently identifiable. Additional reports will be generated when identifying information is provided. Y UNK PVT OTH UNK NONE UNK HQ4274930NOV2000 1
0175018 09/05/2001 VA U 02/14/2001 A nurse reported that a pt received an injection of Pnu-Imune 23 and subsequently, developed an injection site reaction characterized by a "large" area of redness and pain. No further information was available at the date of this report. This is 1 of 3 pts from this facility who developed an injection site reaction following receipt of Pnu-Imune 23. The reporter indicated that 4 pts experienced an adverse event; however, only 3 are presently identifiable. An additional report will be generated when identifying information is provided. U UNK PVT OTH UNK UNK UNK HQ4470405DEC2000 1
0175019 09/05/2001 IL U 12/20/2000 A sales representative reported that a pt received an injection of Pnu-Imune 23 on 11/28/00 and subsequently, developed an injection site reaction characterized by redness and swelling from the top of the shoulder to the elbow. As of 11/29/00, no further information was available. This is 1 of 2 pts from this facility who experienced an adverse event following receipt of Pnu-Imune 23. U 11/28/2000 UNK PVT PVT UNK UNK UNK HQ4596107DEC2000 1
0175020 09/05/2001 MT 61.0 61 M 06/05/2001 A pharmacist reported that he received an injection of Pnu-Imune 23 on 12/8/00. The following day, he developed an injection site reaction characterized by a 8" by 4" area of redness, swelling, warmth and pain. The reporter stated that the symptoms have decreased; however, the pain has "moved down to elbow area". This is 1 of 2 pts from this facility who had an adverse experience following receipt of Pnu-Imune 23 lot 468148. Follow-up received on 5/30/01, indicated that the pt recovered. Y 12/08/2000 12/09/2000 1 UNK OTH OTH Serevent; Combivent; Flovent NONE UNK HQ4794713DEC2000 1
0175021 09/05/2001 OH U 04/16/2001 A nurse reported that a pt received an injection of Pnu-Imune 23. Within 3 days of vaccination, the pt developed an injection site reaction characterized by soreness and redness extending from elbow to shoulder. The pt was seen by the physician. The reporter indicated that 6 pts experienced this event; however, they are not presently identifiable. Additional reports will be generated when identifying information is provided. Y U UNK PVT OTH UNK UNK UNK HQ4880614DEC2000 1
0175022 09/05/2001 IN U 04/15/2001 A pharmacist reported that a pt received an injection of Pnu-Imune 23 and subsequently, the pt developed warmth, pain and redness at the injection site. The reporter described this as cellulitis. The reporter Indicated that 3 pts experienced this event; however, they are not presently identifiable. Additional reports will be generated when identifying information is provided. U UNK OTH OTH UNK UNK UNK HQ4934115DEC2000 1
0175023 09/05/2001 IL 50.0 50 F 03/16/2001 Pt reported that 1 day post vax she developed an injection site reaction characterized by a red, hot, flaming area extending from elbow to shoulder and arm pit. On 10/18/00 she developed a fever of 102F. As of 10/19/00, her symptoms were resolving. This is 1 of 2 pts from this facility who had an adverse experience following receipt of Pnu-Imune-23, lot 468-136. Follow-up info recvd from MD on 3/12/01 indicated that the pt was seen twice by MD. She recovered. Y Y 10/17/2000 10/18/2000 1 NONE OTH OTH NONE NONE UNK HQ5002118DEC2000 1
0175024 09/05/2001 NV U 04/16/2001 A nurse reported that a pt received an injection of Pnu-Imune 23 in 12/00. Subsequently, the pt developed an injection site reaction characterized by redness, swelling and warmth extending from shoulder to elbow. The symptoms resolved within 72 hours. The reporter indicated that 2 pts experienced this event; however, they are not presently identifiable. An additional report will be generated when identifying information is provided. Y 12/01/2000 UNK OTH OTH UNK UNK Pneumonia NOS HQ5118120DEC2000 1
0175025 09/05/2001 IL 74.0 M 04/17/2001 A territory representative reported that a 74 year old male received Pnu-Imune 23 vaccine on 11/27/00. On 11/28/00, he developed "large" cellulitis at the injection site. The reporter noted that the pt received a previous dose of Pnu-Imune 23 on 12/9/99. He was seen in the ER and treated with cephalexin. He recovered. Y Y 11/27/2000 11/28/2000 1 UNK PVT OTH UNK UNK UNK HQ5460503JAN2001 1
0175026 09/05/2001 IA 51.0 51 F 06/05/2001 A nurse reported that a 51 year old female received an injection of Pnu-Imune 23 on 12/20/00. On 12/22/00, the pt developed myalgia, arthralgia, muscle weakness, loss of appetite and a pink, macular rash on the arms, back, chest and abdomen. She also developed a local reaction which the reporter did not describe. Follow-up information received from the physician on 5/30/01, indicated that the pt recovered. Y 12/20/2000 12/22/2000 2 UNK PVT OTH UNK UNK UNK HQ5478703JAN2001 1
0175027 09/05/2001 FL U 04/19/2001 A respiratory therapist reported that a patient received an injection of Pnu-Imune 23. Within 48 hours of vaccine administration, the patient developed an injection site reaction characterized by redness, swelling, and warmth. MANUFACTURER'S COMMENT: The reporter indicated that 3 patients experienced this event; however, they are not presently identifiable. Additional reports will be generated when identifying info is provided. U UNK OTH OTH UNK UNK UNK HQ5482103JAN2001 1
0175028 09/05/2001 CA 70.0 F 02/15/2001 A physician reported that a 70 year old female received an initial injection of Pnu-Imune 23 on 01/09/01. That same day, the patient developed an injection site reaction characterized by 6 cm by 6 cm area of erythema and induration. She was treated with tapering doses of Prednisone "60, 40, 30, 20, 10 mg". The patient was also treated with diphenhydramine 25 mg every 4 hours for 4 or 5 doses. The patient recovered. Y 01/09/2001 01/09/2001 0 UNK PVT OTH UNK NONE UNK HQ5836511JAN2001 1
0175029 09/05/2001 FL 58.0 58 F 03/09/2001 A medical assistant reported that a 58 year old female received an injection of Pnu-Imune 23 on 09/14/00. Within a few hours of vaccine administration, she developed an injection site reaction characterized by heat, redness, pain, and swelling. It was also reported that this patient had received a dose of Pnu-Imune 23 on 10/20/94. This is 1 of 3 patients from this facility who had an adverse experienced following receipt of Pnu-Imune 23 lot 463-015. Follow-up info received from the physician on 03/06/01, indicated that the patient recovered. Y 09/14/2000 09/14/2000 0 UNK PVT PVT Ambien, Darvocet-N, Ditropan. NONE UNK HQ6276123JAN2001 1
0175030 09/05/2001 FL U 01/25/2001 A medical assistant reported that a patient received an injection of Pnu-Imune 23 and subsequently developed an injection site reaction characterized by pain, redness, heat, and swelling. No further information was available at the date of this report. This is 1 of 3 patients from this facility who had an adverse experience following receipt of Pnu-Imune 23 lot 463-015. U UNK PVT PVT UNK UNK UNK HQ6276223JAN2001 1
0175031 09/05/2001 FL U 04/19/2001 A nurse reported that a patient received an injection of Pnu-Imune 23. Subsequently, the patient developed an injection site reaction characterized by redness and swelling which extended from the elbow to middle of the lower arm. The reporter indicated that this was a "booster shot" with the previous injection given >5 years ago. No further info was available at the date of this report. MANUFACTURER'S COMMENT: The reporter indicated that 3 patients experienced this event; however, they are not presently identifiable. Additional reports will be generated when identifying info is provided. U UNK OTH OTH UNK unk unk HQ6354624JAN2001 1
0175032 09/05/2001 MI M 04/19/2001 A nurse reported that a male received an injection of Pnu-Imune 23 on 01/16/01. Subsequently, he developed "general" malaise and "severe" pain at the injection site. The reporter indicated that the patient is "feeling better" but his arm still remains sore. U 01/16/2001 UNK OTH OTH Coumadin, Glucophage, Verapamil UNK UNK 643262 1
0175033 09/05/2001 TX 64.0 64 F 06/05/2001 A physician reported that his 64 year old wife received an injection of Pnu-Imune 23 on 01/24/01. The reporter indicated that this was a booster dose with a previous dose given 5 years ago. Subsequently, she developed a "severe" reaction described as dizziness, head pressure, nausea, and back ache. The patient recovered in 5 minutes. Follow-up info received from the physician on 05/30/01, indicated that the patient also experienced pain of her upper posterior thighs along with the previous reported events within 60 seconds of vaccine administration. All symptoms resolved within 5 minutes with no sequelae. Y 01/24/2001 01/24/2001 0 UNK OTH PVT UNK UK UNK HQ6462226JAN2001 1
0175034 09/05/2001 OH 38.0 38 F 04/19/2001 A medical assistant reported that a 38 year old female received an injection of Pnu-Imune 23 on 01/22/01. That same day, the patient developed nausea and vomited. On 01/25/01, she developed an injection site reaction characterized by redness, soreness, and swelling the "size of a grapefruit". The patient was treated with Keflex and applications of cold packs. U 01/22/2001 01/25/2001 3 UNK PVT OTH Dilor,Midrin, Pulmicort NONE UNK HQ6488129JAN2001 1
0175035 09/05/2001 CO 71.0 71 M 07/17/2001 A nurse reported that a 71 year old male received an injection of Pnu-Imune 23 on 01/18/01. The following day, the patient developed "severe" swelling at the injection site extending from the shoulder to below the elbow. The reporter stated that the reaction "progressed to a cellulitis". He recovered. This is 1 of 2 patients from this facility who experienced this event following receipt of Pnu-Imune 23 lot 469-401. Follow-up info received on 06/26/01 indicated that the patient developed "increased" swelling. He was seen in an ER and treated with Rocephin and doxycycline. The patient was diagnosed with cellulitis and an allergic reaction. He recovered in 1 week. Y Y 01/18/2001 01/20/2001 2 UNK PUB OTH NONE NONE UNK HQ6701901FEB2001 1
0175036 09/05/2001 NY 70.0 M 04/20/2001 A physician reported that a male in his 70's received an injection of Pnu-Imune 23 in 01/01. Subsequently, he developed an injection site reaction characterized by "pronounced swelling and hardness of entire upper arm". The patient also developed a fever. He recovered. MANUFACTURER'S COMMENT: The reporter indicated that 2 patient's experienced this event; however, only 1 is presently identifiable. An additional report will be generated when identifying information is provided. Y 01/01/2001 UNK PVT OTH UNK NONE UNK HQ6797002FEB2001 1
0175037 09/05/2001 KY 70.0 70 F 06/06/2001 A pharmacist reported that a 70 year old female received an injection of Pnu-Imune 23 on 01/30/01. Within 1 day of vaccine administration,the patient developed an injection site reaction characterized by redness, swelling, warmth, and tenderness. She was treated "symptomatically". This is 1 of 2 patients from this facility who experienced this event following receipt of Pnu-Imune 23 lot 469-132. Follow-up info received on 06/06/01 indicated that the patient recovered. Y 01/30/2001 01/30/2001 0 UNK PVT OTH Lotrel, Premarin UNK UNK HQ6930807FEB2001 1
0175038 09/05/2001 PA 44.0 44 F 02/13/2001 Three days post vax pt developed an injection site reaction characterized by swelling, redness and itching. The pt also developed vomiting and chills. She was treated with cephalexin and diphenhydramine. On 11/6/00 the pt was seen by MD who noted improvement. The MD added loratadine to her treatment. By 11/17/00 the reaction had resolved. This is 1 of 4 pts from this facility who had an adverse experience following receipt of 2 different lots of Pnu-Imune-23. Y Y 11/02/2000 11/05/2000 3 UNK PVT PVT Albuterol, Flovent, Meridia, Serevent, Singulair NONE UNK HQ7135312FEB2001 1
0175039 09/05/2001 PA 86.0 86 M 04/05/2001 The day of receiving vax pt developed an injection site reaction characterized by burning, swelling, itching and warmth extending from clavicle area to antecubital. On 11/27/00 he was seen by MD and treated with cephalexin and loratadine. The pt had previously recvd an injection of Pnu-Imune-23 in 1994. This is 1 of 4 pts from this facility who had an adverse experience following receipt of 2 different lots of Pnu-Imune 23. Follow-up info recvd on 3/27/01 from the MD indicated that the pt recovered. Y Y 11/22/2000 11/22/2000 0 UNK PVT PVT Aspirin, Celebrex, Loniten, Monopril, Niferex, Toprol XL NONE UNK HQ7135412FEB2001 1
0175040 09/05/2001 VA F 04/05/2001 Post vax, pt developed an injection site reaction characterized by redness and swelling. This is 1 of 3 pts from this facility who developed an injection site reaction following receipt of Pnu-Imune-23. Manufacturer's Comment: The reporter indicated that 4 pts developed an injection site rx; however, only 3 are presently identifiable. An additional report will be generated when identifying info is provided. Follow-up info recvd from MD on 4/3/01 indicated the pt recovered. Y UNK PVT PUB UNK UNK UNK HQ7182713FEB2001 1
0175041 09/05/2001 AL U 05/01/2001 Approximately 24 hrs post vax pt developed a fever and an injection site reaction characterized by redness and swelling. No further info was available at the date of this report. Manufacturer's Comment: The reporter indicated that 3 pts experienced this event; however, they are not presently identifiable. Addtl reports will be generated when identifying info is provided. U UNK PVT OTH UNK UNK UNK HQ7688526FEB2001 1
0175042 09/05/2001 TX 77.0 77 M 07/11/2001 The afternoon of receiving vax, pt developed an injection site reaction characterized by swelling and redness. He was treated with applications of warm compresses and Tylenol. This is 1 of 2 pts from this facility who developed an injection site reaction following receipt of Pnu-Imune-23, lot 469-132. Follow-up info recvd from MD on 6/25/01 indicated that the pt recovered. Y 02/14/2001 02/14/2001 0 UNK PVT PVT Allegra, Azmacort, Norvasc, Prilosec, Ventolin NONE UNK HQ7802128FEB2001 1
0175043 09/05/2001 CA 38.0 38 F 05/15/2001 Within 24 hours post vax, pt developed a fever of 102F, "aches, pains" and an injection site reaction characterized by redness and swelling. On 3/8/01, pt reported "she feels much better." U 03/06/2001 03/07/2001 1 UNK PVT OTH UNK NONE Hypersensitivity NOS HQ8270112MAR2001 1
0175044 09/05/2001 CA 72.0 72 F 05/29/2001 A physician reported that a patient received an injection of Pnu-Imune 23 vaccine and developed a delayed post-immunization. The reporter described the reaction as "red, almost cellulitic" which lasted for several days. The reporter stated that 7 patients experienced this event following receipt of Pnu-Imune lot 473-556. MANUFACTRER'S COMMENT: The 7 patients were not presently identifiable. Additional reports will be generated when identifying information is provided. Additional information received from the reporter on 08/30/02 provided patient identifiers for 1 patient and the lot number changed from 473-556 to 470-594. The patient remained recovered. Y 08/21/2001 08/21/2001 0 UNK OTH OTH NONE NONE NKA HQ8326713MAR2001 1
0175045 09/05/2001 PA 55.0 55 F 03/21/2001 Later in the day of receiving vax pt developed an injection site reaction characterized by pain, erythema, and hardness. She recovered. Manufacturer's Comment: This is 1 of 2 pts from this facility who had an adverse experience following receipt of Pnu-Imune 23. Y 10/06/2000 10/06/2000 0 NONE OTH OTH UNK NONE UNK HQ8454315MAR2001 1
0175046 09/05/2001 IN 12.0 12 F 07/27/2000 One day post vax pt developed an injection site reaction characterized by redness, swelling, pain, and warmth. Raising her arm was painful. Her mother treated her with acetaminophen and diphenhydramine without relief. MD recommended treatment with loratadine. U 07/17/2000 07/18/2000 1 UNK PVT PVT NONE NONE UNK HQ8894924JUL2000 1
0175047 09/05/2001 NH F 08/17/2000 Post vax pt developed an injection site reaction characterized by redness, warmth, and pain. She also developed lymphadenopathy. She was seen by MD who made a diagnosis of cellulitis and prescribed cephalexin. The pt recovered. This is 1 of 2 pts from this facility who developed cellulitis following receipt of Pnu-Imune 23 lot 468-484. Y Y 07/20/2000 UNK MIL MIL UNK UNK Drug hypersensitivity HQ8896324JUL2000 1
0175048 09/05/2001 NY 45.0 45 M 08/17/2000 One day post vax pt developed a fever of 103F and an injection site reaction characterized by redness and swelling, which extended from shoulder to elbow. The fever resolved after 48 hours. The pt was treated with erythromycin and recovered. Y 07/17/2000 07/18/2000 1 UNK PVT PVT Fexofenadine, Lansoprazole UNK Gastroesophageal reflux, allergies, myelofibrosis HQ8966725JUL2000 1
0175049 09/05/2001 NY U 10/03/2000 Post vax pt developed an injection site reaction characterized by redness, swelling, warmth, and tenderness. No further info was available at the date of this report. Manufacturer's Comment: The reporter indicated that 5 or 6 pts experienced this event; however, they are not presently identifiable. Addtl reports will be generated when identifying info is provided. U UNK PVT PVT UNK NONE UNK HQ9067027JUL2000 1
0175050 09/05/2001 GA 65.0 65 F A nurse practitioner reported that a 65 year old female inadvertently received an intradermal injection of Pnu-Imune 23 vaccine on 03/28/01. That same day, she experienced an injection site reaction characterized by a 2 cm area of warmth, redness, two streaks going up her arms and axillary nodes swelling. No further information was available at the date of the report. Additional information received fromn the reporter on 07/02/01 provided additional information and responsible physician and stated that the patient recovered. U 03/28/2001 03/28/2001 0 UNK PVT OTH Pravachol, Premarin NONE Hypersensitivity HQ9122302APR2001 1
0175051 09/05/2001 3.0 M 06/01/2001 Pt received 3 doses of 23-valent polysaccharide vaccine (manufacturer unk) and "failed on three separate occasions to mount any immune response" to the vaccine. No further info was available at the date of this report. U Drug specific antibody absent-Anti-pneumococcal antibodies absent OTH OTH UNK UNK Cell-mediated immune deficiency HQ9332405APR2001 1
0175052 09/05/2001 PA 74.0 74 M 09/06/2001 a nurse reported tha a 74 year old male received his second dose of Pnu-Imune 23on 03/15/01. Within 48 hours post vax, the pt developed an injection site reaction characterized by redness and swelling which extended to his elbow. The pt was treated "symptomatically" and he recovered. No further info was available at the date of this report. Manufacturer's Comment: This is 1 of 2 pts from this facility who developed an injection site reaction following receipt of Pnu-Imune 23, lot #470-592. See related report HQ1201422MAY2001. FOLLOW-UP information was received from the nurse on 07/13/01. On 03/16/01, the patient experienced injection site pain which kept him awake for two nights following vaccine administration. The patient remained recovered. Y 03/15/2001 03/16/2001 1 UNK PVT OTH Acetylsalicylic acid, Zantac, Kerlone NONE Past conditions: Adrenal adenoma HQ9390306APR2001 1
0175053 09/05/2001 PA 51.0 51 F One day post vax the pt developed "severe" cellulitis. She went to the ER and was prescribed a Medrol dose-pack and Benadryl. As of 3/5/01 the reporter stated that the pt had not yet responded to the prescribed meds. This is 1 of 2 pt from this facility who developed cellulitis following receipt of Pnu-Imune lot # 471-040. Addtl info recvd from the reporter on 6/8/01 stated that the pt recovered. Y Y 04/03/2001 04/04/2001 1 UNK PVT PVT Albuterol, Metaxalone, Pamelor, Prempro, Protonix, Sonata NONE UNK HQ9456809APR2001 1
0175054 09/05/2001 PA 79.0 79 F One day post vax pt developed "severe" cellulitis. She was seen by MD 3/29/01 and prescribed Keflex 500mg qid for 14 days. This is 1 of 2 pts from this facility who developed cellulitis following receipt of Pnu-Immune 23 lot # 471-040. Follow-up info recvd from the reporter on 5/18/01 provided the following information: time of immunization, addtl concomitant meds, no laboratory tests required and that the pt recovered. Y Y 03/27/2001 03/28/2001 1 NONE PVT PVT Calcium, Maxzide, Questran, Synthroid, vitamins NONE UNK HQ9494610APR2001 1
0175055 09/05/2001 IN U 06/07/2001 Six hours post vax pt developed an injection site reaction characterized by a 30mm area of redness and induration and inability to move the arm. The pt experienced nausea and vomiting and developed a fever of 101F. The symptoms resolved within a few days. No further info was available at the date of this report. The reporter indicated that 4 pts experienced these events following receipt of Pnu-Imune 23 vaccine, lot 469-401. See HQ1777307JUN2001, HQ1777407JUN2001 & HQ1777507JUN2001. Y UNK PVT OTH UNK UNK UNK HQ9560211APR2001 1
0175056 09/05/2001 NM 69.0 69 F 05/30/2001 Post vax pt developed generalized itching as well as an injection site reaction characterized by warmth, redness, and swelling. The reporter indicated that the pt is a healthcare professional and self-treated her symptoms (treatment was unspecified). The itching, warmth, redness and swelling resolved. As of 4/12/01 a "small" lump at the site Pnu-Imune-23 administration persisted. This is 1 of 2 patients from this facility who developed an injection site reaction following receipt of Pnu-Imune-23 lot 474-936. Y 04/03/2001 04/03/2001 0 UNK PVT OTH Prednisone NONE Systemic lupus erythematosus HQ9679013APR2001 1
0175057 09/05/2001 UT 37.0 37 F 04/19/2001 The day of receiving vax the pt developed an injection site reaction characterized by tenderness, swelling, redness and warmth. She was treated with Benadryl and applications of moist heat. This is 1 of 2 pts from this facility who experienced this event following receipt of Pnu-Imune-23 lot 466-440. U 01/10/2001 01/10/2001 0 UNK PVT PVT Albuterol, Nasacort, Synthroid NONE UNK HQ9730316APR2001 1
0175058 09/05/2001 IN 31.0 31 F 05/25/2001 The evening of receiving vax the pt developed a fever, nausea and vomiting. She also developed induration at the site of Pnu-Imune-23 administration. She recovered. This is 1 of 2 pts from this facility who had an adverse experience following receipt of Pnu-Imune-23 lot 470-592. A copy of this report has been forwarded to Aventis Pasteur, manufacturer of Td vax. Y 03/16/2001 03/16/2001 0 UNK PVT OTH Hydrochlorothiazide, Prilosec NONE UNK HQ9760517APR2001 1
0175059 09/05/2001 IN 32.0 32 F 07/23/2001 A nurse reported that a 32 year old female received Pnu-Imune-23 and Td vaccine on 04/11/01 On 04/12/01, the patient developed an injection site reaction characterized by redness, soreness and induration at the site of Pnu-Imune-23 administration. As of 04/14/01, her symptoms persisted. This is 1 of 2 patients from this facility who had an adverse experience following receipt of Pnu-Imune 23 (lot 470-592). FOLLOW-UP information received from the physician on 07/03/01 indicated that the patient received vaccines on 04/12/01. On 04/13/01, the patient developed an injection site reaction characterized by a 3-inch area of redness and soreness which "continued to enlarge over the next several days." On 04/14/01, the patient was advised to treat her symptoms with "local care, including ice" On 04/16/01, the patient was seen by the physician who noted that the patient had developed an area of erythema, "slight warmth, "Mild" induration and tenderness "covering the shoulder and half-way down the elbow." The physician considered the reaction to be "possibly a cellulitis" and treated the patient with "IV" Rocephin (ceftriaxone). The patient was subsequently treated with unspecified oral antibiotics. A blood culture was negative and the patient's white blood cell count was 9,100 cells/cubic mm. the physician indicated that the patient recovered "completly." Y Y 04/01/2001 04/13/2001 12 White blood cell count - 9,100 (cells/mm^3); Blood culture - negative PVT OTH Claritin NONE NKA HQ9764317APR2001 1
0175060 09/05/2001 CO U 05/03/2001 Post vax pt developed an injection site reaction characterized by redness and swelling. The pt recovered the same day. This is 1 of 2 pts from this facility who developed an injection site reaction following receipt of Pnu-Imune-23 lot 469-401. Manufacturer's Comment: The reporter indicated that 2 pts experienced this event; however, they are not presently identifiable. An addtl report will be generated when identifying info is provided Y UNK PUB OTH UNK UNK UNK HQ9944220APR2001 1
0175061 09/05/2001 KY 31.0 31 M 07/02/2001 Within 1 day of receiving vax, pt developed an injection site reaction characterized by redness, swelling, warmth, and tenderness. Pt was treated symptomatically. This is 1 of 2 pts from this facility who experienced this event following receipt of Pnu-Imune-23 lot 469-132. Follow-up info recvd on 6/11/01 indicated that the pt recovered. Y 01/29/2001 01/30/2001 1 NONE PVT OTH NONE NONE UNK HQ9946120APR2001 1
0175062 09/05/2001 NH M 08/17/2000 Post vax pt developed an injection site reaction characterized by redness, warmth, and pain. He was seen by MD who made a diagnosis of cellulitis and prescribed dicloxacillin. The pt recovered. This is 1 of 2 pts from this facility who developed cellulitis following receipt of Pnu-Imune 23 lot 468-484. Y Y 07/18/2000 UNK MIL MIL UNK UNK UNK HQ9958417AUG2000 1
0175063 09/05/2001 WV 42.0 42 M 06/06/2001 On 4/21/01, pt developed a fever of 104F and a swollen axillary lymph node. Addtl info rcvd from MD on 5/29/01 indicated that the pt recovered. Y 04/19/2001 04/21/2001 2 UNK PVT PVT Cardizem CD NONE UNK HQ0184726APR2001 1
0175064 09/05/2001 CO 64.0 64 F 12/19/2000 Approximately 45 mins post vax, pt developed pain at the injection site. The reporter described this as "excruciating right interior shoulder pain that is going down through her arm" and is exacerbated with "movement." She was seen by the MD who noted that the injection site "looks good." The pt recovered. Y Y 10/11/2000 10/11/2000 0 UNK PVT OTH Codeine, Darvocet-N, Demerol, Dilaudid, morphine, Premarin, progesterone, Tagamet NONE UNK HQ2272716OCT2000 1
0175065 09/05/2001 NY 81.0 81 M 01/22/2001 Post vax pt developed swelling at the injection site. No further info was available at the date of this report. U 10/23/2000 UNK OTH OTH UNK UNK UNK HQ2998231OCT2000 1
0175066 09/05/2001 VA M 04/09/2001 Post vax pt developed pain at the injection site. No further info was available at the date of this report. This is 1 of 3 pts from this facility who developed an injection site reaction following receipt of Pnu-Imune-23. Manufacturer's Comment: The reporter indicated that 4 pts developed an injection site reaction; however, only 3 are presently identifiable. An addtl report will be generated when identifying info is provided. Follow-up info recvd 4/3/01 from MD indicated that the pt recovered. Y UNK PVT OTH UNK UNK UNK HQ7182813FEB2001 1
0175067 09/05/2001 MO U 04/16/2001 Post vax pt developed a local reaction which the reporter did not describe. Manufacturer's Comment: The reporter indicated that 2 pts developed a local reaction; however, they are not presently identifiable. An addtl report will be generated when identifying info is provided. U UNK OTH OTH UNK UNK UNK HQ9704416APR2001 1
0175068 09/05/2001 NC U 08/23/2000 Post vax pt developed an injection site reaction characterized by tenderness and swelling. This is 1 of 10 pts from this facility who developed an injection site reaction following receipt of Pnu-Imune-23. As of 8/15/00, no further info was available. Manufacturer's Comment: The reporter indicated that 10 pts experienced this event; however, they are not presently identifiable. Addtl reports will be generated when identifying info is provided. U UNK PVT OTH UNK NONE UNK HQ9910416AUG2000 1
0175069 09/05/2001 MD 73.0 73 M 05/25/2001 Pt reported that on 4/6/01 he developed "marked myalgia" in his right leg that subsequently "spread" to his left leg. As of 4/20/01, the reporter indicated that the myalgia is resolving, and he is treating the symptoms with ibuprofen. U 04/03/2001 04/06/2001 3 UNK PVT OTH Ambien UNK Leukaemia NOS HQ9958720APR2001 1
0175071 09/06/2001 FL 0.4 0 .4 M 09/04/2001 A consumer reported that her 5 month old son received his 2nd dose of Prevnar and Hep-B vaccines on 7/23/01. Two days later, the child was hospitalized with sepsis and purpura. No further information was available at the time of this report. F/U info was rec'd on 9/18/01 the hepatitis B vaccine rec'd by the pt was Engerix B. An additional adverse event was reported high pitched crying. The pt was hospitalized for 8 days in an intensive care unit. He subsequently recovered. Y 8 Y 07/23/2001 07/25/2001 2 UNK PVT PVT UNK NONE UNK HQ5440831AUG2001 1
0175073 09/06/2001 AZ 1.0 0 1 F On 6/25/01, the pt had a fever and a seizure X 1. Exam was normal except for fever. Dx'd with viral induced fever versus fever from MMR and febrile seizure. On 7/21/01, had non-febrile seizure. Y Y 2 Y 06/18/2001 06/26/2001 8 Blood chemistry-nml; EEG-nml PVT PVT NONE NONE NONE 1
0175074 09/06/2001 MD 38.0 38 F 08/11/2001 Pt reported that soon after receiving the TD vaccine, she developed dysequilibrium, visual blurring, facial discomfort, severe pain of the right upper extremity and right trapezius area and right upper extremity analgesia. She was later noted with a facial droop and right medial pectus weakness. Y Y 1 Y N 07/13/2001 07/13/2001 0 Cranial MRI-reportedly neg PVT PUB Humulin N Dog bite to hand on 7/8/01 IDDM; Sponge kidney on right 1
0175075 09/06/2001 NC 0.2 0 .2 M 08/29/2001 Post vax, child became pale and white and unconscious for about 1 1/2 minutes, non-responsive to sound or touch. It took 45 minutes to regain normal behavior. Went to ER and admitted. Continued to have episodes that have been dx'd as seizures and he is now on phenobarbital. Y Y 2 U 08/03/2001 08/07/2001 4 CBC, EEG X 2; Cat Scan; MRI; PH Probe; Mod Barium swallow PVT PVT Zantac syrup NONE Reflux 1
0175076 09/06/2001 MO 1.5 1 .5 M Ran fever of 102F and screamed with shot. For the next couple of months, he started not have eye contact, lack of facial expression, starring spells and bizarre mood swings. Per doc 199569, patient ran fever day of injection, crying. The annual follow up states still autistic like behaviors, no eye contact, speech delay. Y N 06/29/2000 PVT UNK Runny nose Allergies at 24 months 1
0175077 09/06/2001 CO 18.0 18 F 08/07/2001 The pt experienced a fever on 7/13/01 which continued until 7/16/01. On 7/18/01 developed a severe debilitating headache. Pain was on "top" of head. Pain was so bad it caused the pt to hyperventilate and become very dizzy. Y 2 Y 07/13/2001 07/18/2001 5 CSF Fluid-neucleated 17; Diff: Poly-71, lymphs-24, glucose-48, protein-54 PVT PVT NONE NONE NONE unspecified~Td Adsorbed (no brand name)~1~15.00~In Patient CO01012 1
0175078 09/06/2001 CO 3.0 3 F 08/23/2001 The pt experienced joint pain and swelling. Went to a physician. Lab test were done and the child was diagnosed with juvenile rheumatoid arthritis. Went to a hospital and diagnosis was confirmed. Parents were told that it might be due to the Varicella Vaccine. The annual follow up states child's diagnosis is rheumatoid arthritis. Child is refusing care. Takes medication. Y Y N 05/01/2000 06/01/2000 31 PUB PUB NONE NONE NONE CO01015 1
0175079 09/06/2001 PA 1.25 1 .3 M 08/28/2001 The pt received vaccines on 8/25/01. On 8/26/01 became febrile to 102, experienced and episode of atonia, unresponsive with forward staring. The pt regained consciousness with lethargy. The pt was taken to ER and given 1 dose of Tylenol and became afebrile thereafter. Y 1 Y 08/25/2001 08/26/2001 1 EKG, EEG, MRI, - all nml PVT OTH NONE NONE NONE 1
0175080 09/06/2001 NJ 0.62 0 .6 F 08/31/2001 Pt started having febrile seizures on 6/19/01, lasting over 1 hour, originally. Dx'd as a Urinary Tract Infection. Original urine results were lost by hospital. All subsequent tests, including urine cultures-neg. The hospital believes seizures are from Prevnar. Y Y Y 4 Y Y 06/12/2001 06/19/2001 7 Blood and urine samples lost, EEG, Cat Scan; WBC: 0; RBC: 0; SP GR: 1.005; pH: 7.0; Albumin: Negative; Glucose: Negative; Ketone: Negative; Bili: Negative; Blood: Negative; Urobilinogen: .2; Leuk Est.: Negative; Nitrites: Negative; Clinitest: Negative; Specimen description: Voided urine; Culture: no growth PVT PVT NONE NONE NONE 1
0175081 09/06/2001 MD 72.0 70 M 08/31/2001 Progressive pain and disability in the following: knee to knee to hip, fingers to shoulders, to elbows, to feet with earaches, failing eye sight and tingling on skin surfaces. Also has finger numbness, muscle pain, head and neck pain. The annual follow-up states "all bones, joints, front teeth very painful. Large muscle cramp and painful disabling at an ever increasing pace disease." Y N 12/03/1999 01/01/2000 29 PVT UNK Various NSAIDS; Thyroid medicine Right knee pain Slightly PSA (5.0); Hypothyroidism 1
0175082 09/06/2001 VA 0.2 0 .2 F 09/05/2001 The pt experienced a fever and was hospitalized on 8/22/01 to 8/24/01. Y 2 Y 08/21/2001 08/22/2001 1 Chem 12 - wnl, WBC - 20.1, UA - neg PVT PVT NONE NONE 1
0175083 09/06/2001 KY 4.0 4 F 08/12/2001 On 7/28/01 pt's upper left arm became hot and swollen. She had no fever. On 7/30/01 pt was taken to the ER since her condition did not improve. She was told she had an allergic reaction. She was put on antibiotics and steroids. Y Y 07/27/2001 07/28/2001 1 NONE PUB PUB NONE NONE NONE cellulitis~Vaccine not specified (no brand name)~~1.00~In Patient KY2001056 1
0175084 09/06/2001 AL 0.9 0 .9 F 08/28/2001 Pt developed initial induration at site of DTAP and polio vax which measured about 4 cm when seen at 24 hrs. Pt was treated symptomatically. She developed vesicles with crusts which resolved. 5 days post vax pt has since developed a similar area of induration on calf with denuded 1 cm ulcerative base of vesicle. Pt also has another smaller papule with about 1 cm of induration on right forearm. Y Y 08/20/2001 08/21/2001 1 Culture of vesicles on forearm-induration similar to that seem with mosquito bites sometimes PVT PUB NONE URI NONE ~Vaccine not specified (no brand name)~2~0.60~In Patient 1
0175085 09/06/2001 MI 0.75 0 .2 M 08/07/2001 After receiving vax pt started screaming and crying uncontrollably. This lasted for 5 days. He also ran a temperature of 100-102. Tylenol was given. Y Y 12/20/2000 12/20/2000 0 NONE PVT PVT NONE Milk intolerance 1
0175086 09/06/2001 OR 1.0 1 .1 F 08/30/2001 Pt developed local induration at injection site with 10-15 blisters, varicella appearance. U 08/15/2001 08/20/2001 5 PVT PVT 1
0175087 09/06/2001 TX 1.0 1 .0 M 08/30/2001 Pt developed fever with convulsion on the sixth day post vax. Y Y 08/22/2001 08/27/2001 5 CBC-leukopenia PVT PUB 8/22/01 PPD right arm NONE NONE 1
0175089 09/06/2001 NJ 0.3 0 .3 M 08/31/2001 The evening of receiving vax pt had a temp of 103.8 and was cranky. On 8/25/01 his temp was 103. The duration of the temp was 1.5 days. Y 08/24/2001 08/24/2001 0 NONE PVT PVT NONE NONE 1
0175090 09/06/2001 OH 1.9 1 1 F 08/23/2001 Pt developed swelling at injection site and hives over entire body day of vax. Pt was taken to ER on 8/16/01 because of difficulty breathing. Y Y 08/15/2001 08/16/2001 1 UNK PUB PUB NONE NONE OH0049 1
0175091 09/06/2001 WI 14.0 14 M 08/23/2001 Pt awoke around 6:30 AM on 8/22/01 with grand mal seizure lasting about 2 minutes requiring Diastat to stop. Pt also noted to have an approximately 7" red area at injection site. The redness resolved over 24 hours. Pt had no other reaction. He was well on 8/23/01. Y 08/20/2001 08/22/2001 2 Recent seizure med levels normal PVT PVT Valproate, Depakene, phenobarbital, Fosamax, Zantac Ear canal abrasions from ear plugs Developmental delay, seizures, blindness seizure~DTP (no brand name)~~0.00~In Patient 1
0175092 09/06/2001 MT 0.6 0 .6 M 08/27/2001 Within 1 hour after receiving vax mother noticed a marked increase in irritability which lasted for 24 hours. Mother stated pt did not have a noticeable fever, but it was not checked. Pt was fine the next day without treatment. Y 05/23/2001 05/23/2001 0 PUB PUB NONE NONE 1
0175093 09/06/2001 CA 0.3 0 .4 F 08/23/2001 Pt started turning head side to side, stiffening, drooling, body taut, making gurgling sounds and shrill, shrieking noises and her skin was sweaty. After 45 mins of attempts to bring her out of what was happening, 911 was called. Paramedic assessed pt as all right at that time. Y 08/16/2001 08/18/2001 2 PVT UNK NONE 1
0175094 09/06/2001 FL 24.0 23 F 08/22/2001 Varicella vaccine was being administered to pt's child when child struggled, and pt was accidentally scratched by clean needle. A clean needle was replaced on the syringe and child was given injection. On 8/22/01 pt complained of runny nose, cough and cold symptoms due to scratch. Y 08/20/2001 08/22/2001 2 PVT PUB NONE 1
0175095 09/06/2001 SC 0.6 0 .6 M 08/17/2001 Mother reported that pt "can't hold his head up." She stated she was taking him to ER because pediatrician told her to. See ER record and nurse's notes. (ER visit unremarkable. Advised mother to "keep an eye on the child.") Pt never had a fever. Y Y 08/15/2001 08/15/2001 0 FSBS-107 in ER PUB UNK UNK SC0141 1
0175096 09/06/2001 CA 1.25 1 .3 F 08/21/2001 Pt started with fever of 101 at 17:30 which was controlled until 22:15. Temperature then went up to 101.8, and at 23:30 it was 104 even with prior cooling measures and Tylenol. Y U 08/20/2001 08/20/2001 0 PUB PVT NONE NONE Apnea and low BS at birth, allergy to penicillin 1
0175097 09/06/2001 WI 1.0 1 .1 F 08/29/2001 Pt had a fever for 3 days post vax. There was no local reaction to the vax. Pt was quite irritable and somewhat listless at times. During this same time frame, the pt was placed on Augmentin for serous otitis. As of 8/22/01 the pt had been off the Augmentin for several days. The pt was eating, but not great, and sleeping a little longer. As of 8/22/01 pt seemed to be gradually getting better. Y Y 08/15/2001 08/15/2001 0 NONE PVT PUB NONE NONE Recurrent otitis 1
0175098 09/06/2001 CA 0.5 0 .5 M 08/28/2001 Pt developed irritability, rash and a decreased appetite. Y 08/22/2001 08/24/2001 2 NONE PVT PVT NONE NONE ~Measles + Mumps + Rubella (MMR II)~1~1.00~In Sibling 1
0175099 09/06/2001 MI 1.0 1 .0 M 08/27/2001 Office visit on 8/27/01 revealed on back of right hand and scattered on lateral arm from tip to shoulder vesicular clusters and isolates with significant erythema and discomfort with palpation. Pt was placed on Acyclovir. Y U 01/26/2001 08/25/2001 211 PVT PVT NONE NONE NONE 1
0175100 09/06/2001 NM 1.4 1 .4 M Pt developed fever to 101.3 which lasted 36 hrs and a rash from head to toe, even on face, soles of feet and palms of hands. Rash had small, raised bumps, and it was still bad on his back and bottom 1 week later. No scratching was noted. The rash is slowly improving and the pt is acting well. U 07/25/2001 UNK UNK fever~Pneumo (Prevnar)~1~1.25~In Patient 1
0175101 09/06/2001 PA 54.0 52 F 08/29/2001 Pt developed arthritic problems in knees, back and neck with swelling. Pt developed fatigue. Pt developed severe joint pain to several joints. The pain travels and pt experiences loss of use of limb until the pain leaves or goes to another joint. Pt could not write or work or lift leg, etc. N 04/07/1999 02/10/2000 309 LYME IgG Western Blot-positive; LYME IgM Western Blot-positive PVT PVT NONE 1
0175102 09/06/2001 KY 4.0 4 F 08/23/2001 About an hour post vax pt broke out with hives all over, in mouth also. Mother took pt to private MD where she was treated with oral Benadryl. Mother was advised to give Benadryl q6h. Pt also had an increased temperature to 103. Pt was fine the next AM. Private MD felt it was "probably vaccine related." Y Y 08/22/2001 08/22/2001 0 PUB PUB NONE NONE NONE KY2001058 1
0175103 09/06/2001 KY 21.0 21 F 08/22/2001 Pt developed a quarter sized red, hot, tender spot that was sore to the touch. The site was swollen the first 24 hrs post vaccine and then red spot was flush to skin at 48 hours post vax. Y 08/20/2001 08/20/2001 0 NONE PUB UNK NONE NONE KY2001057 1
0175104 09/06/2001 MA 4.0 4 F 08/29/2001 Pt developed a 7 x 9.5 cm area of erythema, induration, warmth and swelling on 8/29/01. U 08/29/2001 CBC sent 8/29/01 PVT PUB NONE 1
0175105 09/06/2001 CA 4.0 4 F 08/21/2001 Pt developed redness to left shoulder 5 mins after IPV given. Benadryl 6ml given PO as ordered. Within 20 mins all of the redness had disappeared. There were no respiratory problems and no distress was noted at discharge. Y 08/21/2001 08/21/2001 0 MIL MIL 8/21/01, PPD, Aventis, C0832AA, LA, 3 previous doses Allergy to Bactrim 1
0175106 09/06/2001 VA 27.0 27 F 09/05/2001 Pt developed an 8 cm diameter local area of redness and swelling. Y 08/29/2001 08/30/2001 1 NONE PVT PVT NONE NONE NONE 1
0175107 09/06/2001 IA 13.0 13 F 09/04/2001 On 8/15/01 pt c/o of not feeling well. On 8/18/01 she had fever blisters under tongue. On 8/19/01 the pt developed emesis in the AM. From 8/21/01-8/23/01 pt had an increased temperature, diaphoresis and increased headache. On 8/23/01 she broke a sweat and chilled. 8/24/01 her headache decreased, and on 8/27/01, her sore throat was better. She was treated with Tylenol and increased fluids. Y Y 08/06/2001 08/15/2001 9 NONE PUB UNK NONE NONE NONE 1
0175108 09/06/2001 PA 4.0 4 F 08/23/2001 Pt developed swelling and tenderness of right arm. Y Y 08/21/2001 08/22/2001 1 NONE PVT UNK NONE NONE 1
0175109 09/06/2001 NV 26.0 26 F 08/27/2001 Pt c/o nausea 1-2 days post vax. She then noticed increased left shoulder pain on 8/25/01. On 8/26/01 her left shoulder was swollen. She saw MD on 8/27/01 and was diagnosed with cellulitis and placed on the oral antibiotic Tequin. She was also given antibiotic injections in the office. She was off work x 2 days. She will follow-up with MD on 8/28/01. Y U 08/17/2001 08/25/2001 8 PUB PVT Nascobal, Imitrex, prednisone, NONE Hayfever 1
0175110 09/06/2001 NC 37.0 37 M 08/27/2001 Pt developed hives and a rash on right arm. Y 07/10/2001 07/12/2001 2 MIL MIL NONE NONE 1
0175111 09/06/2001 NC 34.0 34 M 08/24/2001 Pt developed hives on legs, arms, stomach and feet approximately 1 hr post vax. Y Y 08/23/2001 08/23/2001 0 MIL MIL NONE NONE 1
0175112 09/06/2001 MI 4.0 4 M 08/28/2001 29 hours after vaccines given pt developed fever and severe headache requiring visit to ER. Symptoms lasted 24 hours. Y Y 08/23/2001 08/24/2001 1 PVT OTH Singular, Albuterol NONE Asthma, moderate to persistent, eczema, milk intolerance 1
0175113 09/06/2001 TX 1.9 1 .9 M 08/28/2001 3 days after vaccinations he started getting a few red bumps on mouth causing irritability and refusal to eat. Benadryl, Mylanta, and Carafate swish Wednesday without any much relief. Next day he had scattered red raised bumps on neck and face with multiple ulcers on roof of mouth and on tongue. Resolved without further treatment. Y Y 08/14/2001 08/17/2001 3 PVT PVT NONE NONE NONE 1
0175114 09/06/2001 PA 4.0 4 M 08/25/2001 Fever onset several days after immunization. Vomiting and stomach pains same day as immunizations. Y Y 08/21/2001 08/21/2001 0 PVT PUB Albuterol NONE Asthma 1
0175115 09/06/2001 WA 4.0 4 M 08/28/2001 Child presented to office on 8/3/01, 2 days after vaccination with left upper arm swelling and redness from shoulder joint to elbow joint. Y Y 08/01/2001 08/02/2001 1 PVT PUB NONE NONE NONE 1
0175116 09/06/2001 NV 44.0 44 F 08/01/2001 Pt complained of itching all over his body with raised red blotchy areas beginning on 8/25/01 in the evening. Pt instructed to seek medical follow up. U 08/24/2001 08/25/2001 1 PUB PVT NONE NONE allergy to latex, and plastics 1
0175117 09/06/2001 NH 18.0 18 F 08/24/2001 After injection started with rash on chest and felt tired with chills and feverish. Complained of back pain with increased shortness of breath by afternoon. Seen in ED around 6:30 PM on 8/23/01. Y Y 08/22/2001 08/22/2001 0 PVT PUB NONE NONE Allergy to shellfish 1
0175118 09/06/2001 OR 70.0 70 F 08/28/2001 Upper left arm has became increasingly red, itchy, swollen and hot starting about 2 days after immunizations. Client called on 8/23/01 and was advised to see primary care provider for evaluation. Client reports she was seen in immediate care on 8/24/01. They told her that this was an allergic reaction, put on a course of antihistamine. As of 8/28/01 redness, swelling, have resolved but itching continues. Y Y 08/16/2001 08/18/2001 2 PUB PVT ASA, Vitamin E NONE NONE 1
0175119 09/06/2001 CA 3.0 2 .9 F 08/27/2001 Large, red induration at site of injection on right thigh. Size is 10-12 cm. Y 08/20/2001 08/21/2001 1 NONE PVT PVT NONE NONE NONE 1
0175120 09/06/2001 SC 11.0 11 F 08/30/2001 72 Hours after vaccination pt started having loose stool, headache, sore throat, nausea, vomiting, and rash. On 8/27/01 diarrhea was resolved and rash was resolving. Y 08/17/2001 08/23/2001 6 CBC-no results given, H&H 13.4 and 40.2, WBC 6,700 and platelets 285,000. All WNL. PVT PUB NONE NONE NONE 1
0175121 09/06/2001 WI 45.0 45 F 08/31/2001 Pt had temperature, swelling arm, sore throat, and skin rash. Rash on left arm, then neck, chest and right arm. Y 08/24/2001 08/25/2001 1 OTH PVT NONE NONE NONE 1
0175122 09/06/2001 OR 4.0 5 F 08/29/2001 Large area of swelling and redness left upper arm. Y 08/27/2001 08/28/2001 1 NONE PVT UNK NONE 1
0175123 09/06/2001 CA 0.4 0 .4 F 08/09/2001 Pt had 2 cm area of red and swollen noted on the morning after the vaccine was given. Reported fever of 102 F the same AM. Was not documented in office. Y Y 06/26/2001 06/26/2001 0 NONE PVT OTH NONE NONE NONE 1
0175124 09/06/2001 CA 11.0 11 M 08/20/2001 Left upper arm to mid lower arm swollen with scattered red bumps; decreased after 2 days to swelling of deltoid, red bumps only in deltoid area. Right upper arm with swelling deltoid without red bumps with no symptoms on Sunday (2 days). Mother applied warm compresses and cream for itchiness. Y 08/17/2001 08/17/2001 0 Tuberculin PPD no results UNK UNK PPD in the left forearm Cough 1
0175125 09/06/2001 CA 4.0 4 M 08/17/2001 Swelling and redness with fever started on Thursday morning on 8/16/01. Ice applied. By Friday 8/17 09:15 AM significant swelling X 3 size of left upper arm with redness and warmth. Rash started today with itching. U 08/15/2001 08/16/2001 1 Tuberculin PPD given -results unknown. PVT PUB NONE NONE NONE 1
0175126 09/06/2001 VA 50.0 50 M 08/15/2001 Swelling at injection site. Diffuse recurrent myalgia since injection. Y N 07/23/2001 07/29/2001 6 NONE PVT OTH NONE Cut on leg NONE 1
0175127 09/06/2001 FL 48.0 48 M 08/28/2001 Red spot below injection site, warm to the touch. No itching. Y 08/09/2001 08/09/2001 0 NONE OTH OTH NONE NONE NONE 1
0175128 09/06/2001 TX 1.08 1 .1 F 08/28/2001 One week after shots pt began to run 102-103 F fever. One week and 3 days later small pinpoint rash began to develop all over her body. U 08/17/2001 08/17/2001 0 PVT OTH NONE 1
0175129 09/06/2001 AK 4.0 4 F 08/31/2001 Pt seen by MD on 8/26/01 with onset 4 days post vaccination of itchy, erythematous papules 1-2 cm with appearance of insect bites but not known hx of exposure. Approxiamtely 10 lesions over body on left arm, back thigh, abdomen and ankle. Pt was seen first for condition at urgent care and started on Prednisone. Y U 08/20/2001 08/24/2001 4 NONE PVT PUB NONE NONE NONE AK200151 1
0175130 09/06/2001 WI 1.0 0 1 F 08/30/2001 Development of fever within a week of the MMR, then exanthem (looking like German measles) with lymphadenopathy around 2 days later. Y 08/09/2001 08/16/2001 7 PVT UNK 1
0175131 09/06/2001 CO 4.0 4 F 08/28/2001 24 hours after pt received vaccinations she developed hives on legs where shots were given. Within the next 24 hours she developed hives, erythemtous macules with raised papules on eyes, arms, trunk, face, hands. 48 hours later pt developed fever, 99-100 F and diarrhea. Y Y 08/22/2001 08/23/2001 1 NONE PVT PVT NONE NONE 1
0175132 09/06/2001 PA 18.0 18 F 08/28/2001 Pt developed extensure urticaria and chest tightness. Y Y 08/24/2001 08/26/2001 2 NONE PUB UNK Sore throat and fever Asthma 1
0175133 09/06/2001 TN 4.0 4 F 08/29/2001 Soft tissue infection -cellulitis at injection site Y 08/28/2001 08/29/2001 1 PVT PUB NONE NONE NONE 1
0175134 09/06/2001 FL 34.0 34 F 08/28/2001 Developed itching on arms, legs, chest, about 30 minutes after vaccine. Pt developed intermittent chest tightness around 1 1/2 hours after vaccine. Treated with Benadryl. After discharge from clinic on 8/23/01, he presented to ER later that evening for continuation of symptoms. Treated with Vistaril and Famotidine for 3 days. Re-evaluation in clinic on 8/27/01, still with itching and intermittent chest tightness, complaining of muscle spasms and feeling jittery. Vistaril dc and started on Benadryl, Famotidine continued. Re-evaluation on 8//28/01 improved. Y Y 08/23/2001 08/23/2001 0 NONE PUB PVT NONE allergy to codiene 1
0175135 09/06/2001 IL 4.0 4 M 07/29/2001 After 48 hours, 2/3 of upper arm was still red, swollen and hot to the touch. Pt complained it hurt. Treatment was ice pack. Y Y 06/24/2001 06/27/2001 3 NONE PVT OTH NONE NONE NONE ~DTP (no brand name)~2~0.50~In Sibling 1
0175136 09/06/2001 CA 0.5 0 .5 F 08/29/2001 Pt was seen for routine 6 month WBC on 8/15/01 and received vaccinations. That night baby was noted to have simultaneous squirming, grimacing and jerking body lasting around 1 second. Initially occurred every 5 or 6 seconds and gradually tapered off over nest 2-3 hours. Seen in ED for evaluation. Last episode noted less than 24 hours after vaccines. Pt's mental status between events seemed normal, smiling. Y Y 08/15/2001 08/15/2001 0 EEG on 8/21/2001 results normal. Neurology consult pending. PVT UNK NONE NONE NONE 1
0175137 09/06/2001 UT 26.0 26 F 08/30/2001 Post vax, her heart began racing, arm hurt and she had difficulty breathing. She went to ER and they treated her, run tests and told her it couldn't be from Hep-B and was probably a panic attack. These symptoms lasted 2 days, but she felt ill for 2 weeks. Y Y 07/27/2001 07/27/2001 0 PUB PVT NONE NONE NONE 1
0175138 09/06/2001 MD 6.0 6 M 08/27/2001 Redness increased to 6.5cm X 4cm and induration increased to 2cm X 1.5cm on the left thigh. Y 08/21/2001 08/22/2001 1 NONE MIL MIL PPD/Aventis/C031AA/ID NONE NONE 1
0175139 09/06/2001 CA 2.0 2 .2 M 08/30/2001 Fever, papular erythematous rash with itching on face, arms and legs, 1 day, post vax. Alert and active. Being treated. U 08/28/2001 08/29/2001 1 PVT PUB NONE Nasal lacrimal duct obstruction (9/00) 1
0175140 09/06/2001 22.0 22 F 08/24/2001 Pt received Japanese Encephalitis #2 and had pruritus with inflammation at the injection site, 24 hours later. Also, had swollen hand. U 08/22/2001 08/23/2001 1 MIL MIL Tricycline NONE NONE 1
0175141 09/06/2001 TN 16.0 16 F 08/31/2001 On 8/1/01, at the time of the injection, the pt became weak and "slumped-like in chair". She did not lose consciousness. Pt was very nervous about receiving the injection. A few days later, it was reported that the pt began having "spells" and has lost consciousness at least 2 times for "a few seconds" (less than 5 sec). Since then pt has experienced "spells" of nausea, sweating, malaise, chills, weakness, flushing, anorexia, insomnia, irritable and easily agitated. She is seeing PP and referred to cardiologist. Symptoms continue to occur rather frequently. Y U 08/01/2001 08/01/2001 0 EKG-WNL; general lab work-all WNL; EEG and Holter scan (results not in). All test reported by mother. PUB PUB NONE NONE NONE 1
0175142 09/06/2001 OH 1.25 1 .3 M 08/31/2001 Mother states around 15:00, the same day of immunization, the pt developed a rectal temperature of 103F. He did not respond to Motrin and in fact, temperature fluctuated up and down, not related to time that Motrin was given. He had a high-pitched cry that could not be consoled. When not crying, he was pale, listless and at times seemed to be staring into space. He would sleep occasionally but then awake and cry, this lasted about 48 hours. He was getting "back to normal on 8/25/01 although tired and not as active as usual. On 8/27/01, he was back to his usual self". (Also, he had some vomiting the first day). Y 08/22/2001 08/22/2001 0 NONE PUB PUB NONE NONE Hospitalized X 2 weeks at birth. Born with group B Strep; tubes in ears; frequent ear infections Temperature~DTaP (no brand name)~3~0.40~In Patient 1
0175143 09/06/2001 OH 1.08 1 .1 F 08/31/2001 On 7/24/01, the pt spiked a temperature of 104F and with the fever also developed a generalized red body rash. She would take liquids but would not eat. The fever did respond to Tylenol. The rash and fever lasted approx. 2 days then disappeared. No other symptoms. Y 07/17/2001 07/24/2001 7 NONE PUB PUB NONE NONE NONE 1
0175144 09/06/2001 NC 18.0 18 F 08/23/2001 Hep-B vaccine given on 7/27/01 at approx. 14:00 and by 17:00, the pt began itching. Total body rash followed. By 22:00, the pt had swelling in her throat. Treated with Adrenaline and Depo-Medrol injection, oral Benadryl and Prednisone and improved in 3 days. Y U 07/27/2001 07/27/2001 0 PUB PUB Tetracycline Tetracycline for acne NC01075 1
0175145 09/06/2001 NC 0.2 0 .2 M 08/07/2001 On 8/3/01, the infant started feeling a little warm and had a temperature of 100.3F. The infant was fussy but ate well and slept well. He was seen in ER on 8/4/01 with a temperature of 101.3F. This was after the child was given Tylenol. Child also had 2 loose stools. Bumps were present which the doctor said was mosquito bites. The ER doctor said symptoms were due to immunizations. Y U 08/02/2001 08/03/2001 1 Blood culture; CXR PUB PUB NONE NONE NONE NC01076 1
0175146 09/06/2001 MA 31.0 31 F 08/17/2001 Headache, drowsiness, paresthesia of left hand, swelling, pain and redness over the site of the injection on left deltoid with decreased grip strength on left side. Treat with ice and Tylenol. Y Y 08/15/2001 08/15/2001 0 NONE PVT PUB Naproxen Sodium Work related injury (laceration) Allergic rhinitis 1
0175147 09/06/2001 TN 14.0 14 M 08/16/2001 Client received 1st Hep-B and 2nd MMR at 14:15 and waited with mother in waiting room for 20 minutes with no reaction. Returned to health dept at about 15:05. Mother stated child began to experience a rash with itching. He was noted as having generalized redness, rash and hives over trunk, face and neck and pallor at nose and mouth. No SOB. Treated with Epinephrine 1:1000, 0.3ml given SC in left arm at 15:10. Benadryl 50mm given IM in left arm at 15:15. 911 was called and EMS transported to hospital for evaluation and treatment. Y Y 08/15/2001 08/15/2001 0 NONE PUB PUB NONE NONE Allergy to Penicillin TN41042 1
0175148 09/06/2001 OR 5.0 5 M 08/23/2001 On 8/22/01, right arm was red and swollen (upper part of arm) and was complaining of itching this AM. On 8/23/01, arm was red, swollen and hot. Mother of child considering taking child to MD. Y U 08/21/2001 08/22/2001 1 PUB PUB NONE NONE NONE OR200129 1
0175149 09/06/2001 OR 5.0 5 F 08/23/2001 On 8/21/01, Tuesday night, pt started bruising of left deltoid and redness. By 8/22/01, Wednesday, site was red, swollen and tender with complaint of discomfort at side and client is not wanting to use left arm. Thursday assessment of left arm; redness of deltoid measuring about 50cm X 70cm. Mother of client had treated with po Tylenol with good results of decreasing discomfort at site but it is now itching and warm to touch. Y 08/21/2001 08/21/2001 0 OTH PUB NONE NONE NONE OR200130 1
0175150 09/06/2001 OR 1.08 1 .1 M 02/14/2000 The pt experienced fussiness, fever and vomiting. then the pt experienced a rash on the face, neck, and trunk and body. No known exposure to chicken pox. N 02/04/2000 02/12/2000 8 PUB PUB NONE runny nose NONE OR200131 1
0175151 09/06/2001 OR 4.0 4 F 08/20/2001 According to pt's mother; pt had severe swelling of left arm, redness, warmth and painful to touch. She was taken to MD and states possible allergic reaction to DTAP but unsure. Could be possible infection. Y Y 08/13/2001 08/14/2001 1 PUB PUB NONE Autism OR200132 1
0175152 09/06/2001 OR 1.0 1 .0 F 08/21/2001 A rash began on 8/17/01 around her mouth and the night of 8/20/01 was all over her body. She had a fever of 107F on 8/17/01 and 8/18/01 and baby didn't want to move her legs. She slept less, cried more than usual and fever only lasted 2 days. It was relieved with Motrin. The rash is ongoing. As of 8/21/01, the baby was acting normal. Y Y 08/16/2001 08/17/2001 1 NONE PUB PUB NONE NONE NONE OR200133 1
0175153 09/06/2001 TX 4.0 4 F 08/10/2001 The pt returned to the clinic the same day of vax with wheals on her face. No other complaints. Was referred to another facility. Requested the Mom to call the clinic to report. Y Y 08/09/2001 08/10/2001 1 PUB PUB NONE NONE NONE TX01124 1
0175154 09/06/2001 TX 4.0 4 M 08/06/2001 Within 24 hours of receiving vax pt developed temperature of 102 with shaking. Pt also developed increased area of erythema, tenderness, swelling, heat and induration over injection site. Pt was limping. His right inguinal nodes were present. He was diagnosed as having cellulitis versus local immunization reaction. He was treated with Clindamycin. Follow-up on 7/31/01 indicated pt was much better. Y Y 07/24/2001 07/25/2001 1 PVT PVT NONE NONE 1
0175155 09/06/2001 SC 4.0 4 M 08/28/2001 Mother reported that pt's "tongue, lips, eyes, throat and penis swelled." "They gave him liquid steroids." Y Y 08/24/2001 08/25/2001 1 NONE PVT PVT NONE NONE NONE 1
0175156 09/06/2001 CO 37.0 37 M 08/20/2001 Six hours post vax pt had 3 episodes of vomiting and felt lightheaded. Y 08/17/2001 08/17/2001 0 OTH PVT 08/17/01 Tubersol, Aventis, C0631AA, Intradermal left forearm NONE NONE CO01016 1
0175157 09/06/2001 CO 12.0 12 F 08/22/2001 Pt developed a temperature, aching all over and severe headache. She was treated in an urgent care clinic. The symptoms persisted for 5 days. Y Y 06/12/2001 06/12/2001 0 All lab tests negative PUB PUB NONE Allergy to Amoxicillin CO01014 1
0175158 09/06/2001 CO 47.0 47 F 08/16/2001 At the time the vaccine was administered, there was a burning experience by the pt. A 2" hard lump (raised) developed at the site. Pt's arm was swollen and painful for 2 weeks. They symptoms persisted and have slowly improved. There is now a "dent" at the site and the arm is still "sore". Pt is seeing own MD (X 3) for continued evaluation of injection site. Y N 06/11/2001 06/12/2001 1 NONE PVT PVT NONE Finger laceration Possible allergy to Cipro CO01013 1
0175160 09/06/2001 CA 1.0 1 .0 M 08/20/2001 Pt developed 2 blister lesions over the left thigh area of induration. Discharge is clear and drying. Y Y 08/08/2001 08/17/2001 9 NONE PUB PUB PPD/Parkedale/00390P/ID/LFA NONE NONE CA010089 1
0175161 09/06/2001 TX 1.25 1 .3 M 08/27/2001 At doctor's office well check visit on 8/1/01 showed sleep issues and potty training issues. Also, on return to clinic, the pt is still lethargic and has a persistent fever even after antibiotics were started for strep throat. On 8/1/01, child received DTAP and varicella vaccines. On 8/2/01, mom reported redness and swelling at varivax injection site and was told to apply ice or cold cloth every 15 minutes. No fever per doctor. She was told to call if no better on Friday and to see in office. On 8/3/01, per mom, pt is doing great, swelling and redness is all gone. On 8/9/01, child has rash (bumps around varicella vaccine site) came back yesterday as bumps (was initially a rash, post vax). Child says "ouch" and holds it. Ice applied. Child is irritable but has no fever. Child has 20 vesicular lesions at the site of injection of vaccine, lumps and a 2cm nodes/mobile. Ears are now clear. Pt was dx'd with chickenpox at right thigh administration. Treating with Aveeno and Benadryl. Call if symptoms of infection, fever or increased cough or any other questions. On 8/10/01, pt has rash around injection site and it seems worse today, per mom and lotion applied. Pt had periods of rapid breathing since noon today, as though he is out of breath and does this off and on. Benadryl and Motrin given last night but fever increased to 101.6F (ax). On exam; left TM with hard cerumen and right pearly grey TM. Oral pharynx 2+ tonsils and erythema, few small cervical nodes. Extremities with 4cm circular area of erythema at vaccination site with 3 clusters of vesicles. Dx'd on 8/10/01, with vaccine related, localized varicella at right thigh; cold with pharyngitis and tonsillitis (probably viral) and self limited rapid respirations causing NAD, possibly secondary to fever. Treated with Augmentin. On 8/14/01, mom reported child taking water and white grape juice this AM, had diarrhea X 2 this AM and bright orange urine (1 semi-wet in 13 hours). He is now refusing grape juice and milk. Admitted and given IV fluids and recovered, uneventfully with no antibiotics. Y Y Y 08/01/2001 08/02/2001 1 CBC PVT PVT NONE Hyaline Membrane Disease (perinatal Dis); Cow's milk intolerance. On 7/11/01 lymph nodes in neck were swollen and pt would not talk with questionable sore throat; pt also, had a temperature of 101.6 (Ax) and was dx'd with strep throat and treated with Amoxicillin for 10 days. 1
0175162 09/06/2001 CA 4.0 4 F 08/29/2001 The pt came to the clinic on 8/27/01 with red swollen and warm left deltoid. The child was taken to the ER. Y Y 08/24/2001 08/24/2001 0 PUB PUB developmental delay hx of seizure disorder 1
0175163 09/06/2001 PA 71.0 71 F 07/26/2001 The pt experienced soreness, swelling, redness, axilla of left arm. Symptoms persisted then worsened on the breast, neck and ear. Saw MD on 7/30. Prescribed antibiotics. Y Y 07/17/2001 07/19/2001 2 PUB PUB PA0154 1
0175164 09/06/2001 NJ 1.5 1 .5 M 08/31/2001 This infant had a fever of 105 four hours after his shot. A fever of 103 lasted 2 1/2 days, which was managed w/ children's Advil. Then a low grade fever for two days; 2nd low grade day, roseola developed. Y Y 08/17/2001 08/17/2001 0 PVT UNK NONE NONE NONE 1
0175165 09/06/2001 FL 35.0 35 F 08/29/2001 On 08/29/2001, This patient came to FIU complaining of fine rash all over her body. Nodes in back, neck, sore throat, rash began 08/28/01. Sore throat began 08/26/01. U 08/15/2001 08/28/2001 13 OTH PUB Alesse NONE Heart murmur, Anemia. 1
0175166 09/06/2001 MO 5.0 5 F 08/24/2001 Approximately 6:00 PM, on 08/14/01, this patient had shortness of breath, and body jerking. It began to subside approximately 8:00 PM. The patient did not see the ER or a physician. Called the health dept at 2:30 PM, on 08/24/01, stating the child's arm was still sore. Y 08/14/2001 08/14/2001 0 PUB PUB NONE NONE NONE ~DT Adsorbed (no brand name)~3~7.00~In Sibling MO2001044 1
0175167 09/06/2001 FL 14.0 14 F 08/31/2001 This patient had a fever, blisters on her neck, and trunk. Y 08/14/2001 08/30/2001 16 PVT PVT NONE NONE NONE 1
0175168 09/06/2001 MS 23.0 23 M 10 days, post vax, pt had a rash and right anterior cervical adenopathy. Y U 07/15/2001 07/28/2001 13 CBC-WNL; RPR-Pending OTH PUB 1
0175169 09/06/2001 LA 0.5 0 .5 M 08/22/2001 This infant had Bell's Palsy on the right side of his face. He eats okay. Mother says the MD thought it was a reaction to HBV vaccine. N 08/14/2001 08/20/2001 6 Lyme test. PUB PUB NONE NONE NONE LA010805 1
0175170 09/06/2001 WV 23.0 F 08/28/2001 Pt immediately complained of nausea and became unresponsive. Epipen was given and pt was sent to ER. Y Y 08/28/2001 08/28/2001 0 PUB PVT 8/28/01 Tubersol given in right forearm NONE NONE 1
0175171 09/06/2001 ND 8.0 8 F 08/23/2001 On 8/22/01 pt came to clinic with right arm reddened from shoulder to elbow. She was referred to MD. On 8/23/01 pt returned for recheck. The swelling and redness had gone down but it was still warm to touch. Y N 08/20/2001 08/22/2001 2 NONE PVT UNK NONE ADHD 1
0175172 09/06/2001 FL 6.0 6 F 08/28/2001 Pt developed swelling and tenderness at injection site several hours post vax. The area was 5 x 5 cm with 3 x 3 cm central erythematous, elevated area on left anterior thigh. Recommended treatment was cool compresses and NSAIDS. Y 08/14/2001 08/15/2001 1 PVT PVT NONE NONE NONE 1
0175173 09/06/2001 AK 31.0 F Pt developed right arm and neck pain, myalgia, swollen eyes, and rash. U 08/15/2001 08/16/2001 1 NONE UNK UNK 1
0175174 09/06/2001 MD 42.0 42 M 08/14/2001 Pt developed 2-5 raised, vesicular lesions and itching on scalp and left chest 10-14 days post vax. He had no fever. Y 07/19/2001 07/29/2001 10 Varicella IgG & IgM-both positive PVT UNK Allegra prn NONE Allergic to quinine and pollens 1
0175180 09/07/2001 FL 4.0 4 M Pt developed blisters in hands and arms around 4 weeks after immunizations. 2 weeks after blisters he developed bruising. Platelets were down to 6,000. His diagnosis was acute ITP. Y Y 2 Y 04/02/2001 05/14/2001 42 5/21/01 Hgb was 10.7, WBC 8700 and platelets 6,000 UNK UNK NONE NONE 1
0175181 09/07/2001 IL 6.0 M 07/17/2001 Within 10 minutes of receiving immunizations, child was dyspeneic and pale. gave epinephrine subq and 911 called. Transferred to Hospital where he was kept for 24 hrs. Y Y 1 Y 07/09/2001 07/09/2001 0 OTH PUB NONE NONE IL01030 1
0175182 09/07/2001 NC 0.3 0 .4 F 08/27/2001 When vaccines were given pt had inconsolable crying for 4 hrs. She had no fever. She was screaming like she was hurting as reported by mother. Calm at 13:49 when called to check back, pt asleep and no fever. Y 08/27/2001 08/27/2001 0 PVT PUB NONE NONE NONE NC01077 1
0175183 09/07/2001 GA 1.0 1 .0 M 09/06/2001 Diagnosis is varicella on 09/06/01 10 plus lesions on trunk and arms. Y Y 08/22/2001 09/06/2001 15 PVT PVT NONE NONE 1
0175184 09/07/2001 OH 57.0 57 F 08/28/2001 The pt presented to health department on 8/28/2001 with a complaint of redness, swelling and itching. The pt's onset of symptoms were on 8/25/01. Symptoms noted on left deltoid and upper arm. Pt sent to family MD for evaluation. Y N 08/21/2001 08/25/2001 4 PUB PUB allergy to Amoxicillin 1
0175185 09/07/2001 CA 5.0 5 M 08/31/2001 Pt developed a 4cm X 6cm erythema and edema at injection site. Y U 08/29/2001 08/31/2001 2 NONE UNK UNK NONE 1
0175186 09/07/2001 NC 72.0 72 F 08/27/2001 About 3 or 4 hours after shot the site had a little redness and itching about it. No real pain / soreness. The next day the patient noted she was sore all over, legs, back, (generalized). She states this problem has not been resolved at all and keeps her from alot of activities; until this date 08/27/01, still having problems. No fever during this episode or any problems. U 05/07/2001 05/08/2001 1 NONE PUB PUB Occasional Tylenol. Dog bite to the lower calf. Allergies to Sulfa and Amoxicillin. NC01078 1
0175187 09/07/2001 IL 1.25 1 .3 F 08/27/2001 Mother noticed around 13:30, a rash around the injection site on the right thigh. She described it as a rash that was red, flat and splotchy and about the size of the mother's palm. Also reported that child was having diarrhea X 4 between 13:30 and 15:00. The mother took the child to the doctor and was instructed to put warm compresses on the thigh. As of 13:00 on 8/28/01, the child is doing well; no rash or diarrhea. Y Y 08/27/2001 08/27/2001 0 PUB PUB NONE NONE Allergic to red dye 40 IL01033 1
0175188 09/07/2001 IL 5.0 5 M 08/24/2001 On 8/22/01, mother called stating that child had started running a fever of 103F and vomiting on the evening after vaccines. She denies redness or soreness at injection sites. On 8/24/01, the child recovered, per mother. Y 08/21/2001 08/21/2001 0 PUB PUB NONE NONE IL01032 1
0175189 09/07/2001 IL 10.0 10 F 08/16/2001 On 08/16/01, this patient's mother called and stated the child developed "heat like" rash on both arms, elbows to hands, and on left side of face the evening after the vaccine was given. No redness. soreness, or swelling at the injection site. No rash at the injection site. Rash was gone the next AM. Y 08/14/2001 08/14/2001 0 PUB PUB NONE NONE NONE IL01031 1
0175190 09/07/2001 IL 6.0 6 F 08/22/2001 Mom in on 8/20/01, and states injection site developed blister-like area and had a hardened area and was warm to the touch. Pt was seen in ER and told it could be a reaction to bandaid or vaccine. Site open and red on 8/20/01 but no knot felt. Mom is using ice to site. Y Y 08/16/2001 08/17/2001 1 PUB PUB IL01029 1
0175191 09/07/2001 AL 5.0 5 M 09/03/2001 Pt developed large localized hives at injection site, 18 days, post vax. followed by generalized fine, red, papular lesions of trunk on the 18th day, which disseminated over entire body. He was seen at the clinic and treated with Benadryl prn. Lesions are present, 2 weeks after office visit with itching. Y N 08/14/2001 08/27/2001 13 NONE MIL UNK Levothyroxine NONE Hypothyroidism 1
0175192 09/07/2001 WY 5.0 5 M 08/27/2001 The pt experienced a fever of 101 orally, 24 hours post vax, 5-8 cm erythema, induration, itching and pain over left deltoid. Symptoms have resolved by day 15. Y 08/06/2001 08/07/2001 1 NONE PUB PUB NONE NONE NONE 1
0175195 09/10/2001 3.0 3 U 08/30/2001 Information has been received from a physician concerning an approx. 4 year old pt who, before 4 years of age, was vaccinated with varicella virus vaccine live. On 8/6/01, the pt was hospitalized for dermatome zoster C6, 7 and 8 and meningitis. It was noted that the culture from 1 of the herpes zoster lesions grew VZV at the hospital laboratory. A CSF specimen was also collected. The child has been discharged from the hospital. Additional information has been requested. F/U states a CSF specimen was also collected and was VZV (+). The vaccine strain was identified by the PCR analysis. The child is fully recovered and has been discharged from the hospital. His herpes zoster lesions resolved 7-8 days after the acyclovir treatment began. The meningeal signs were mild and have also resolved. It was noted that the child is back on his maintenance dose of chemotherapy and being followed from home. Additional information has been requested. no additional info was reported. Y Y Y 01/01/2000 08/06/2001 583 On 8/6/01 CSF-VZV (+); wound culture=(+) herpes zoster lesion OTH OTH UNK UNK WAES01081728 1
0175200 09/10/2001 IN 78.0 78 M 08/29/2001 Less than 24 hours after receiving shot, this patient developed soreness, tenderness around injection site. Became inflamed, red/ swollen area which progressively spread down his arm and through out his shoulder. Admitted to the local hospital, work up for septic arthritis (-) did aspirations showing (+) WBC. Placed on antibiotics and steroids. Discharged after 72 hours home. diagnosed with acute synovitis in left ahoulder Y 3 Y 08/20/2001 08/21/2001 1 PVT UNK COPD, Atrial Fib, Gerd, arthritis 1
0175201 09/10/2001 NJ 1.41 1 .4 F 09/04/2001 Pt began to stumble, sometimes not able to walk. ? limping. Examined on 8/14/01 and 8/16/01 with a normal exam. Examined on 8/18/01 and noted to be ataxic. Referred to neurologist who saw on 8/22/01 and noted to be weak in lower extremities with absent deep tendon reflexes. Guillain-Barre Syndrome; received IVIG on 8/28/01 and 8/29/01. Y Y 8 Y 07/23/2001 08/13/2001 21 MRI of brain-neg; LP-elevated protein in spinal fluid PVT PVT Child did have a cold (URI) beginning in August NONE 1
0175202 09/10/2001 PA 1.0 1 .0 F 08/31/2001 Pt developed a red area about 80mm X 40mm on leg, that was warm to touch and slightly tender to touch. Site of problem area Rt leg. Y 08/29/2001 08/30/2001 1 NONE PUB PUB NONE NONE NONE 1
0175203 09/10/2001 VA 1.75 1 .0 M 08/30/2001 The pt experienced small vesicles scattered over the body. Y 11/30/2000 08/30/2001 273 PVT OTH 1
0175204 09/10/2001 TX 0.2 0 .2 F 08/29/2001 This infant was extremely irritable, with unconsolable crying for 12-15 hours. Febrile off and on for 12 hours, hives for 4 hours. Given Tylenol and Benadryl. Y 08/27/2001 08/27/2001 0 PVT PVT 1
0175205 09/10/2001 DE 1.0 0 .8 M 08/31/2001 Parents report a 5 day period, immediately following the day on which the pt received his vaccinations, during which he had decreased activity and was not acting like himself. Y 05/23/2001 05/24/2001 1 NONE PVT PUB Albuterol nebulizer sol NONE Reactive Airway Disease 1
0175206 09/10/2001 OK 0.2 0 .2 M 09/04/2001 Pt developed a fever of 105F. Y 08/31/2001 08/31/2001 0 NONE PVT PUB Nasal congestion Preemie 1
0175207 09/10/2001 TX 18.0 18 M 08/23/2001 Likely, all a vasovagal event, but his symptoms were quite prolonged. Within about 20 seconds, post vax, while standing, pt fainted briefly. He came to and was sitting down and then fainted again after BP cuff deflated. We laid the pt down. BP was 90/60, then 108/60 after 2 minutes; then 130/80, 3 minutes later. No airway compromise or rash. Pt was scared and had cool and clammy extremities for about 45 minutes. O2 sats were more than 98%. Pt had full recovery and no medicines were administered. Y 08/16/2001 08/16/2001 0 PVT PVT NONE Allergy to shrimp and "pollens". Pt gave a history of rash and breathing difficulty after shrimp is eaten. 1
0175208 09/10/2001 TX 0.6 0 .6 M 07/31/2001 Pt presented with mild edema. Mom reported that 1 day, post vax, he developed redness and swelling at the site where the DTAP had been placed. Left arm soak recommended twice a day. Y 07/24/2001 07/25/2001 1 PUB UNK NONE NONE TX01123 1
0175209 09/10/2001 IL 1.25 1 .3 F 09/04/2001 Mother states, the morning after receiving vaccinations, left leg became very red, swollen and hot to touch. Child was scratching at it. Child was hot but temperature was not taken. Seen by MD on 8/30/01 and given Benadryl and ibuprofen. On 9/4/01, child has recovered. Y 08/28/2001 08/29/2001 1 PUB PUB NONE NONE 1
0175210 09/10/2001 MA 1.08 1 .1 M 08/31/2001 Pt developed a high fever (maximum of 103.4F) and a rash. Pt developed fever 8 days, post MMR. He received Amoxicillin X 48 hours after ER visit. Y Y 08/17/2001 08/25/2001 8 CBC; WBC-9.6 (Neut 18, lymphocytes 71); Blood culture-neg PVT PUB NONE NONE NONE 1
0175211 09/10/2001 NY 28.0 28 F 09/04/2001 Pt complaining of dizziness, diaphoresis about 8 hours, post vax. Complained of chills, 24 hours, post vax with dizziness. Afebrile. Seen by PMD, 24 hours, post vax. Per employee, pain medication given and note written for 2 days off. Employee has weekend scheduled off; no lost time. Y Y 08/30/2001 08/30/2001 0 NONE OTH UNK NONE NONE Allergy to eggs 1
0175212 09/10/2001 MI 0.2 0 .2 F 08/30/2001 Pt developed diarrhea X 6 days, post vax. Pt was fussy and had a low-grade temperature of 100.9F. Y 08/22/2001 08/22/2001 0 NONE PVT PVT NONE NONE NONE 1
0175213 09/10/2001 ME 0.25 0 .2 F 08/31/2001 Pt had inconsolable crying X 3-4 hours. She also had a large, red lump on her thigh at injection site. Y 07/20/2001 07/20/2001 0 NONE PVT UNK NONE NONE NONE 1
0175214 09/10/2001 VA 6.0 6 M 09/04/2001 High temperature (40C or 104F) started late night and lasted to the the next morning. With Tylenol, temperature became normal during the next day but rose again by evening. With another Tylenol, pt finally recovered by the 3rd day. To be noted, pt had a high temperature from having 1st and 2nd DTP at the age of 6 months and 7 months. Y 08/17/2001 08/17/2001 0 PUB PUB NONE Pt had PPD skin test on 8/14/01 that was (-). 1
0175217 09/11/2001 MA 89.0 88 F 08/30/2001 An 88 year old female patient, received "Tetanus and Diphtheria Toxoid Adsorbed for adult use" vaccination on 06/21/01, for a cat bite which became infected. Four days after receiving the injection, she developed a red, swollen, hot area at the injection site. She reported it to her doctor who recommended putting cold compresses on it for relief. Three days later she entered the ER with vomiting, diarrhea, achy joints, fatigue, sour taste, and inability to swallow. She was evaluated and sent home with a diagnosis of viral gastroenteritis. Three days later she was admitted into the hospital. She was severely dehydrated and with all of the previous symptoms. She spent nine days in ICU where, after performing numerous test, the attending staff failed to make a diagnosis. She was fed through TPN because of her inability to swallow. In addition, she had fluid built up around her heart and lungs. She improved slightly and was released from ICU and admitted into a nursing care facility. The patient was readmitted to the hospital 08/14, with a high fever (105 C) and a staph infection for which she is currently being treated. Also diagnosed with atrial fibrillation and constipation. Y Y Y U 06/21/2001 06/25/2001 4 PVT UNK Meclizine UNK Dizziness, Rheumatic fever AE0114 1
0175218 09/11/2001 KY 49.0 49 F 03/01/2002 A nurse reported that a 49 year old female NP received Flu Shield (2000-2001) vaccine on 11/3/00. The NP stated that the shot "felt like a normal shot"; however, within a few days, she developed muscle tenderness at the injection site. The soreness in this area continued and she received physical therapy to the area in 12/00. She was treated with rofecoxib (Vioxx) for the discomfort. On 1/4/01, an MRI was done which revealed "muscle tears and irritation to posterior aspect of left rotator cuff-tendonosis". The nurse practitioner stated that this was the same area from where she had been experiencing discomfort since the immunization. She denied other injury to the area. This report was considered serious since muscle injury and injection site pain were considered "Medically Important" in this case. No additional information was available as of the date of this report. no additional info was added with this follow up. On 02/21/02, follow up was recieved from the reporter. The pt was continued to experience pain. On 09/06/01, arthroscopy of the shoulder was performed; the surgeon shaved bone and repaired the rotator cuff. She was hospitalized for 23 hrs. The pt gradually developed increased range of motion and slowly recovered. She is currently doing well. Y U 11/03/2000 06/04/2001 213 6/4/01-Nuclear MRI-muscle tears and irritation to posterior aspect of left rotator cuff-tendonosis PUB OTH NONE NONE UNK HQ5486904SEP2001 1
0175220 09/11/2001 NY 0.75 M 09/07/2001 A nurse reported that a male child received Cholera vaccine, USP along with Typhoid and DTAP vaccines in 1985, at 9 months of age. According to the nurse, the child's parents allege that he developed mental retardation as a result of Cholera vaccine, USP administration. Mental retardation is considered "Medically Important". No further information was available at the date of this report. The reporter indicated that the child received DTAP vaccine in 1985; however, Wyeth Lederle did not manufacture DTAP vaccine in 1985. F/U states on 10/16/01, it was found that the primary suspect was inadvertently listed as Cholera Vaccine (Lederle). This report is being resubmitted with the primary suspect now listed as Cholera Vaccine, USP (Wyeth). U 01/01/1985 UNK OTH OTH UNK UNK UNK HQ5536305SEP2001 1
0175221 09/11/2001 FL 0.4 0 .1 M 09/07/2001 On 07/23/01, the vacinee received his second dose of Engerix-B and a dose of 7-valent pneumococcal conjugate vaccine (Prevnar; Lederle Labs). Reportedly, two days after receiving Engerix-B, the vaccinee woke up with a high-pitched cry and was taken to the ER. In the ER, LP done results not provided. Reportedly, the vaccinee was admitted to the ICU with "blood infection, red spots on legs". Reportedly, the diagnosis was sepsis. The vaccinee "stayed eight days in th ICU". As of 08/30/01, the events had resolved. Y Y 8 Y 07/23/2001 07/25/2001 2 07/01 Lumbar Puncture - results not provided. PVT PUB 20010210101 1
0175223 09/11/2001 PA 0.2 0 .2 M 09/05/2001 Vaccines given on 8/23/01 and had onset of bleeding symptoms on 8/25/01-8/26/01. Dx'd to have ITP on 8/27/01. Y Y 3 Y 08/23/2001 08/26/2001 3 08/27/01 Plt count = 3,000; other heme parameters -WNL. PVT PVT NONE NONE NONE 1
0175224 09/11/2001 FL 3.0 3 M Pt developed swelling of eyes, increased fever, rash and hives over entire body with itching. Rx given per pt's MD. Y U 09/04/2001 09/05/2001 1 PUB PUB Slight cough; afebrile 1
0175225 09/11/2001 VA 0.5 0 .5 F 09/06/2001 Pt cried immediately after shots for 45 minutes, every hour for 24 hours. Y 09/04/2001 09/04/2001 0 PVT PVT NONE NONE 1
0175226 09/11/2001 NC 1.0 1 .0 F 07/25/2001 Mother states that child had a fever of 105F, starting the night of the shots. The next day, a red, raised rash occurred. The child was taken to ER and a Urinalysis was done. On Sunday, 7/15/01, she was taken back to ER and blood work and X-rays done. Now the child is here on 7/18/01 and was seen at encouragement of nurse to be seen by PMD due to continued rash and fever. Taken in by mother on 7/25/01. No fever since 7/19/01 and no rash since 7/21/01. The pt has frequent fevers per mother. Y Y 07/13/2001 07/14/2001 1 Blood work; Urinalysis and X-rays PUB PUB UNK NONE NC01079 1
0175227 09/11/2001 FL 1.75 1 .8 F 08/22/2001 Pt developed a rash (red splotches) covering her whole body. Treated with Benadryl po for 24 hours and at site was red, hot and hard. Y Y 08/20/2001 08/20/2001 0 MIL MIL NONE NONE NONE 1
0175228 09/11/2001 UT 0.7 0 .7 M 08/30/2001 Pt's right thigh was swollen by 24 hours, post vax. DTAP given in right upper thigh. Left thigh was a little swollen, also. Prevnar given in left upper thigh. On 9/3/01, follow-up call; there are 2 lumps or knots, one in each upper thigh. Y 08/29/2001 08/30/2001 1 NONE PUB PUB ibuprofen NONE NONE 1
0175229 09/11/2001 OH 4.0 4 M 09/06/2001 Pt received Prevnar on 9/4/01 (2nd dose). As per mom, the pt woke up on 9/5/01 with erythematous rash around right eye, neck and arm and also had pruritus. Y 09/04/2001 09/05/2001 1 PUB PUB NONE NONE 1
0175230 09/11/2001 PA 1.08 1 .1 M 09/04/2001 Pt developed a low-grade fever which began the day after receiving the immunizations. On the 3rd day, fever went to 101.8F and mother noticed he was having a seizure. She called the ambulance and was seen in ER. Rectal temperature was 102.2F and pt was given Tylenol and had no further episodes. Y Y 08/27/2001 09/01/2001 5 Rectal temperature-102.2F PVT PVT NONE NONE 1
0175231 09/11/2001 NH 1.0 1 .0 M 08/31/2001 Mother called on 8/28/01 to notify us of a rash. Pt was seen in office today, 8/31/01, on Friday. Lesions are fading, red spots (fine) all over body. Seems fine and is not ill. Now has poison ivy lesions as well. Y Y 08/21/2001 08/28/2001 7 NONE PVT PUB NONE Pt is a triplet and was premature. 1
0175232 09/11/2001 MD 40.0 36 F 08/22/2001 Localized swelling, redness, soreness in arm with each Anthrax injection, worsening headaches, chronic fatigue, myalgias, arthralgias and night sweats since 4/98. Had (+) PPD 9/97 with 6 month course of immunizations. Initially, thought symptoms were due to INH; now thinks are due to Anthrax. N 02/24/1998 02/28/1998 4 (-) aldolase; Lyme Ad, Pb, Hg, Anemic; MRI, CT, CBC, ESR (40-14) MIL MIL INH NONE Allergy to Sulfa 1
0175233 09/11/2001 NY 1.25 1 .3 F 09/05/2001 On 9/4/01, pt developed a fever (100F-103F), slight cough and sneezing. Y Y 08/31/2001 09/04/2001 4 NONE PVT PVT NONE NONE NONE 1
0175234 09/11/2001 DE 4.0 4 M 08/29/2001 On 8/21/01, pt's left arm was tender, red and swollen. Inflammatory reaction to DTAP. On 8/24/01, inflammatory process resolved. Y Y 08/20/2001 08/20/2001 0 PVT PVT Allergic condition vs RAD-coughing Mild persistent RAD 1
0175235 09/11/2001 CO 43.0 43 F 09/05/2001 Pt developed arthritis and arthralgia to multiple joints, following MMR vaccine (10 days). Y 07/25/2001 08/04/2001 10 NONE PVT PUB NONE NONE NONE 1
0175236 09/11/2001 TX 0.25 0 .3 M 08/30/2001 Pt had a macular rash over left arm that appeared on body in 2-3 minutes/not papular. Y 08/30/2001 08/30/2001 0 PVT PVT Pre-pyloric stenosis (repaired) 1
0175237 09/11/2001 NY 1.08 1 .1 F 09/06/2001 Pt developed actual case of measles. Y 08/24/2001 09/01/2001 8 PVT PUB NONE NONE 1
0175238 09/11/2001 FL 7.0 7 M 08/28/2001 Child was given vaccines at 10:30 AM and was doing well and then in the next 10 minutes, post vax, child collapsed to the floor, no injury occurred. Child became pale, eyes fixed, unresponsive and jerking for approx. 1 minute. Then was aroused and regained consciousness and responded appropriately to questions and commands. Y 08/28/2001 08/28/2001 0 PUB PUB NONE NONE NONE 1
0175239 09/11/2001 CA 29.0 28 F 08/21/2001 Pt referred from clinic for Hep-B Series and had shot #1 on 10/20/00 PM. One hour later, she had difficulty breathing, a wheezing noise in her chest, pain in her left chest and down her left arm. She also had dizziness for 2 1/2 days. The pt sought no medical care. Has no medical insurance. Did not report until today. This has resulted in the pt refusing Hep-B dose 2 and 3. Y 10/20/2000 10/20/2000 0 NONE PUB PUB NONE NONE NONE 1
0175240 09/11/2001 WV 1.0 1 .0 M 09/05/2001 Pt had emesis beginning 1 hour, post vax of MMR and emesis and fever to 102F continuing for a day (about 24 hours). He then acted well and illness resolved. Also, he had a fine, papular exanthem on trunk which resolved. Y Y 09/04/2001 09/04/2001 0 PVT PVT NONE NONE Mild reactive airway disease 1
0175241 09/11/2001 OH 1.25 1 .3 M 09/02/2001 This child had ran a fever after having MMR shot. Then he had a febrile seizure a week after the shot was given. Y U 07/17/2000 07/26/2000 9 Blood work ran - no findings PVT OTH NONE NONE NONE 1
0175242 09/11/2001 GA 1.0 1 .0 M 07/30/2001 Acute urticarial rash on day of visit (7/25/01). Seen on 7/23/01 for 1 year well child visit and had routine immunizations. Y Y 07/23/2001 07/25/2001 2 PUB PUB Dermatitis and emesis Atopic dermatitis 1
0175243 09/11/2001 ND 5.0 5 M 08/29/2001 Developed a rash, arm became swollen, firm, tender and warm to touch X 2 days, post vax. Y Y 08/21/2001 08/21/2001 0 NONE PUB UNK NONE NONE ND0105 1
0175244 09/11/2001 AK 5.0 5 F 08/30/2001 Pt developed an upper body rash. PA said it looked like MMR reaction but did not receive MMR. Mother was vague about timing and said it started a couple of days, post vax, and lasted a few days. Totally resolved now. Y 08/14/2001 08/16/2001 2 NONE PUB PUB NONE NONE Milk allergy Unspecified reaction~Measles + Mumps + Rubella (no brand name)~1~1.50~In Patient AK200158 1
0175245 09/11/2001 AK 8.0 8 M 08/27/2001 Pt received shots on 8/10/01 and had red marks on shoulders Friday night but had been playing football. By 20:00, Saturday night, (away from home), had itching, circular rash on stomach and it was worse by 02:00, Sunday, over shoulders, arms and back with welts. Pt was given Benadryl and is continuing on Benadryl, Cortizone cream and Aveeno baths. Hives resolved after 4 days. Doctor wrote medical comments for future Hepatitis shots. Y 08/10/2001 08/11/2001 1 NONE PUB PUB 4 days prior had respiratory inf NONE Fever~Vaccine not specified (no brand name)~~0.00~In Patient AK200157 1
0175246 09/11/2001 AK 11.0 11 M 08/30/2001 Face and fingers were swollen and itchy when he woke up during the night, post vax. Gave Benadryl and eczema cream with good results. After 1 week, pt was totally recovered. Saw pediatrician and has waiver for future hepatitis shots. Y Y 08/17/2001 08/18/2001 1 NONE PUB PUB NONE NONE Eczema; allergic to wheat, citrus, dyes, (food) AK200156 1
0175247 09/11/2001 AK 14.0 14 M 08/24/2001 Mom reports that this young man had nausea and fever beginning the night of 8/21/01 and then vomiting and diarrhea beginning 8/22/01. As of 8/23/01, the symptoms continues. Mom reports that child had similar symptoms, lasting 1 week, after vaccinations on 7/11/01. U 08/13/2001 08/21/2001 8 NONE PUB PUB NONE NONE NONE Fever, nausea and vomiting and diarrhea~Hep B (Engerix-B)~1~14.00~In Patient AK200155 1
0175248 09/11/2001 AK 15.0 15 F 08/23/2001 Pt developed a papular rash within 24 hours, post vax, that developed into hives. Cleared and reappeared the next day but no episodes since. Y 08/13/2001 08/14/2001 1 PUB PUB NONE NONE AK200154 1
0175249 09/11/2001 AK 2.0 3 F 08/27/2001 Child broke out in hives, had swelling around eyes and slight wheezing. Seen in office and put on Zyrtec which is helping but hives are still present, 3 days later. Pt previously was tested for egg allergy and was a low (+). U 08/23/2001 08/23/2001 0 (+) prick skin test to eggs PVT PUB NONE NONE AK200152 1
0175250 09/11/2001 NY 1.2 1 .2 F 09/04/2001 Pt woke up on 9/2/01 with several lesions on the right side of her face over to her hairline. On 9/3/01, another lesion was noticed between her fingers of her left hand. Is now improving. U 08/16/2001 09/02/2001 17 PUB PUB Unspecified reaction~Measles + Mumps + Rubella (no brand name)~1~1.00~In Patient|~DTP (no brand name)~1~0.20~In Sibling 1
0175251 09/11/2001 PA 4.0 4 M 08/31/2001 Pt had a local reaction to DTAP characterized by a firm area that was warm with erythema, measuring 6cm X 8cm. No fever. Treated with Motrin 2 1/2 tsp QID prn pain, cool compress and recheck in 1 week. U 08/28/2001 08/29/2001 1 PUB PUB NONE NONE Sulfa drug allergy 1
0175252 09/11/2001 PA 1.75 1 .7 M 08/31/2001 Pt had marked swelling with wheal and 8cm circle and warm to touch. Refusing to walk and cries when area is touched. Y 08/29/2001 08/30/2001 1 PVT PVT NONE Allergies to Augmentin and Cefzil 1
0175253 09/11/2001 IA 2.0 1 .9 F This child got a light case of spots on 08/07/01 and on 08/10/01 developed a high fever of 102 or above for 4 days. She gave the chicken pox to her dad also his spots started on the 8th. Y Y 08/01/2001 08/07/2001 6 PVT OTH NONE NONE NONE 1
0175254 09/11/2001 LA 1.25 1 .3 M 08/29/2001 Mom states that child woke up screaming and holding his legs into his body. Unable to calm and went to ER and was told it was "a reaction to pertussis in the DTAP that he had received earlier that day at the doctor's office". Went to ER at 22:30 and was given Motrin at ER. Y Y 08/28/2001 08/28/2001 0 PVT PVT Amoxil 250 3/4 tsp TID; Dimetapp Sinusitis; Right serous otitis Asthma 1
0175255 09/11/2001 KY 25.0 25 F 08/31/2001 Injection given on 8/28/01 and states rash started on 8/28/01 PM. Rash was on both arms, legs and chest. Over the counter allergy meds taken (Benadryl). Rash resolved on 9/4/01 AM. Y 08/28/2001 08/28/2001 0 PUB OTH UNK UNK UNK 1
0175256 09/11/2001 TX 1.0 2 .0 F 09/04/2001 The pt experienced erythema and vesicles at the site of injection along with a single erythematous papule on back. Y U 08/22/2001 09/02/2001 11 PVT PUB Reglan, Phenobarbital, Paragotic prematurity - 24 week 1
0175257 09/11/2001 WI 2.2 2 .2 M 08/30/2001 Pt started running an elevated temperature in late afternoon on 8/29/01. He then began to have small jerking movements of arm, head and tongue stuck out. This lasted for a while. At 01:00, on 8/30/01, temperature was 102.5F (ax); no jerking. Mom did not check temperature on the afternoon of 8/29/01. Today he is fine with no temperature; no jerking and is playing. Y 08/28/2001 08/29/2001 1 NONE PUB PUB NONE NONE NONE 1
0175258 09/11/2001 PA 15.0 14 F 05/31/2001 Pt developed a rash. Y Y 05/03/2001 05/17/2001 14 PVT UNK NONE NONE Asthma; Hay fever 1
0175259 09/11/2001 MO 49.0 49 F 07/13/2001 On 7/11/01, fever increased to 103F and had intermittent low-grade fevers which responded to antipyretics. Pt had a large, localized reaction "erythema", lump and edema/swelling at injection site of approx. 8". Symptoms resolving on 7/18/01. Y 07/10/2001 07/11/2001 1 PUB UNK NONE Left hand laceration Asthma (maybe) MO2001041 1
0175260 09/11/2001 NH 5.0 4 M 08/21/2001 After less than 24 hours, pt reported to mother, itching of arm, and right arm became erythematous and papular rash with vesicles. U 08/13/2001 08/14/2001 1 NONE PVT UNK NONE 1
0175261 09/11/2001 DC 33.0 33 F 08/31/2001 Client presented with large erythema and induration on left deltoid, at site of TD injection. Y 07/09/2001 07/10/2001 1 PVT PVT NONE 1
0175262 09/11/2001 UT 0.7 0 .7 M 08/21/2001 Pt's mother reported a rash to the health dept and personal physician that covered the baby's diapered area only and some crankiness, after the 2nd dose of immunization which was given on 4/10/01. The rash did not occur until 1-2 days, post vax. At the same time, DTAP, Comvax and IPV were all given to pt. Pt's PMD recommended that we continue immunizations but split them up and give 1 or 2 at a time. We continued to give immunizations as recommended by physician, giving only 1 at a time and had no reactions until after infant received Act-Hib. Mother reported pt had diarrhea all week before getting immunization, thinking it was due to teething. She also reported that reactions started with a mild fever on 8/16/01 PM. By 8/17/01, she noticed a small red rash on one of his knees and the immunization site was red and warm. On 8/18/01, the rash had spread to his cheeks and forehead near his eyebrow area. He also started throwing up, was feverish (unknown how high), and continued to have diarrhea. At this point, she decided to take him to the ER, which labs were drawn and dehydration was dx'd from the diarrhea. He was given IV, 1 liter of fluid, and discharged to home. It appears to me that hospitalization occurred because of the hydration that had already started before immunization was given, but other symptoms may have exacerbated it. Y N 08/16/2001 08/17/2001 1 Labs drawn-dehydration PUB PUB NONE Diarrhea Allergy to previous immunizations (unknown which) Severe rash~Vaccine not specified (no brand name)~2~0.40~In Patient 1
0175263 09/11/2001 OK 0.4 0 .4 M Mother called 7/12/01 and stated that child developed a rash about an hour, post vax. She checked his temperature at 12:30 on 7/13/01 and it was 102.4F. The next AM at 08:00, the temperature was gone. Instructed her to take him to the doctor and have the rash checked. She saw a PA at the ER. Child was given 1 dose of Benadryl. The PA stated the rash was flat, erythemic papular over trunk and extremities with a positive wheeze and fever reaction. Skin with petechial-type lesions; not raised. The PA stated she thinks the child is allergic to a component in 1 of the vaccines; probably the tetanus in the DTAP. The rash was gone, 2 days later, without further medication or doctor visits. Y Y 07/11/2001 07/11/2001 0 NONE PUB PUB Motrin 1 hour before shots NONE NONE 1
0175265 09/14/2001 CA 0.09 0 .1 M 09/05/2001 Death certifcate states cause of death to be SIDS. This is confirmed by autopsy results. Y 03/04/2001 N 02/27/2001 03/04/2001 5 NONE PVT OTH Hep-B immunoglobulin/Nabi/3106910/LL/0 previously NONE NONE 1
0175266 09/14/2001 OH 33.0 33 F 08/27/2001 Information has been received concerning a female consumer who on 6/6/01 and 7/16/01 (previously reported as 7/17/01) was vaccinated with the 1st and 2nd doses of varicella virus vaccine live, respectively (sites unknown). There was no concomitant medication. Subsequently, the pt found out she was 6 weeks pregnant on 7/19/01. The pt sought unspecified medical attention. Follow-up information received from the pt, on 8/15/01, indicated that she had a missed abortion. Additional information has been requested. F/U states: an adverse event onset date of ?/8?/01 has been added. This is a corrected report as amended. Y U 07/16/2001 08/01/2001 16 UNK OTH OTH NONE Pregnancy (LMP-6/6/01); tetracycline allergy WAES01071942 1
0175278 09/14/2001 MN 1.0 0 1 U 08/28/2001 Information has been received from a consumer concerning an approx. 1 year old twin who in approx. 3/98, was vaccinated with MMRII. It was reported that the child has been dx'd with autism. Three other pts (WAES 01081467; 01082120; 01082119 (twin)) had similar experiences after vaccination with MMRII. The consumer reported that there may be other cases as well. Upon internal review, Autism was considered to be an "Other Important Medical Event". Additional information has been requested. N 03/01/1998 UNK OTH UNK UNK WAES01082832 1
0175279 09/14/2001 1.0 0 1 M 06/26/2001 Information has been received from a consumer concerning her 12 month old son who on 03/19/98 was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live. That same day he seemed "glazed over", wasn't playing with his friend and stopped eating. It was noted that before the vaccination he played with his friends and ate a lot. These symptoms continued and he was diagnosed with autism 05/07/00. Three other patients had similar experiences after vaccination with MMR. The patients mother reported that there may be other cases as well. Upon internal review Autism was considered an other important medical event. Additional info has been requested. Y U 03/19/1998 03/19/1998 0 OTH OTH UNK UNK WAES01081467 1
0175280 09/14/2001 1.0 0 1 U 08/28/2001 Information has been received from a consumer concerning an approx. 1 year old twin pt who in approx. 3/98, was vaccinated with MMRII. It was reported that the child has been dx'd with autism. Three other pts (WAES 01081467; 01082120; 01082832 (twin)) had similar experiences after vaccination with MMRII. The consumer reported that there may be other cases as well. Upon internal review, Autism was considered to be an "Other Important Medical Event". Additional information has been requested. N 03/01/1998 UNK OTH UNK UNK WAES01082119 1
0175281 09/14/2001 MN U 08/28/2001 Information has been received from a consumer concerning a pt who was vaccinated with MMRII and subsequently the pt was dx'd with Autism. Three other pts (WAES 01081467; 01082119; 01082832) had similar experiences, post vax, with MMRII. It was reported that there may be other cases as well. Upon internal review, Autism was considered an "Other Important Medical Event". Addition information has been requested. N UNK UNK UNK UNK WAES01082120 1
0175284 09/14/2001 GA F 08/28/2001 In approximately 2001, after vaccination, the child "swelled up and turned cyanotic". It was noted that the physician who reported the event did not administer the vaccinations. It was unknown if medical attention was sought. No further info was provided. Upon internal review, "turned cyanotic" was determined to be an other important medical event. U OTH OTH UNK WAES01082510 1
0175285 09/14/2001 NY 1.0 1 .0 F 08/26/2001 On approximately 10/08/97, about two weeks after vaccination, the child "was found limp in her crib". The child was then hospitalized for an irregular heart beat. No further info was provided. Y 09/24/1997 10/08/1997 14 OTH OTH UNK UNK WAES01081915 1
0175288 09/14/2001 1.08 1 .1 M 12/31/2001 On the evening of the day of vaccination, the patient developed a temperature and became irritable and difficult to settle. The temperature resolved the next day but the patient remained groggy for approximately 2 to 3 days following the vaccination. On 08/19/93, the day following the vaccination, the patient developed diarrhea which lasted for 2 days. One week following the vaccination, on approximately 08/25/93 the patient developed a rash behind both ears which faded in the next few weeks, but did not disappear completely. It was noted that the patient's health and behavior deteriorated gradually after the MMR vaccination. With in a few weeks of the injection, the patient's personality began to change and he became withdrawn. The rash, which developed behind his ears following the MMR vaccination faded but did not disappear and his eyelids became very red in color. In addition, he began to develop night sweats. By the beginning of November of 1993, the patient had become very irritable and "grisly" (Irritable was considered to be an incidental finding). He also developed a very pale. almost white complexion, lost of appetite and would frequently suffer from upset stomachs (Pallor and loss of appetite were considered to be incidental findings). By this time, the patient lost interest in social interaction and play and developed an increased need for sleep, often sleeping for long periods of time. He became fussy with foods and would only eat certain foods and would no longer eat foods he had previously enjoyed. This fussiness has continued. He no longer seemed to cry or respond to painful stimuli. At this time, he began walking on his tip toes which he continued to do and began dribbling and putting various objects into his mouth. By Christmas 1993, the patient's behavior had become increasingly disruptive. He had tantrums and disliked leaving home environment. In addition, he had developed an obsession with a toy and had lost his concentration and would no longer respond to others when they attempted to communicate with him. His thirst patterns also increased at this time and this was accompanied by a deterioration in his speech as he seemed to loose words he had used prior to the MMR vaccination (increased thirst pattern was considered to be an incidental finding). Shortly after these symptoms developed, the patient began to suffer diarrhea and the color of his motions occasionally became cream in color. On 07/25/95, the patient was noted to have poor concentration, little or no eye contact and was very uncooperative. The patient was diagnosed to have Autistic Spectrum Disorder in January 1996. It was noted that the patient had no relevant pre-vaccination conditions or relevant family medical history. The patient did not receive any other vaccinations containing MMR and did not have measles, mumps, or rubella infection. The patient's Autistic Spectrum Disorder was considered to be an other important medical event. No further info was available. Additional info from the pt's medical records noted tha tthe pt was seen on 11/8/95 by a pediatrician. The pediatrician noted that the pt was born at term by spontaneous vertex delivery weighing arund 7 lbs. There were no neonatal problems. The pt's mother recalled that the pt has normal milestones, although she couldn't recall exact dates. There were no concerns about sitting, walking or talking. the pt has one older sister. The pt's father required soem extra help at school for reading difficulties but there was no other family history of any speech/language or behavior problems. The pt had no serious illness of note and his general health was good. He slept well at night. His appetite was variable; however, there wasn't a particular type of food that the pt refused to eat. The pt's mother had taken him away from other playgroups previously; however, he had started at a private nursery where he has a 1:1 helper. The pt's mother was delighted because it was noted that his behavior was very good there and he had started to play with other children. The pt's mother was very pleased because the last time he was at the nursery he had wanted to know all the other children's names and had gone up to them and stroked their hair. He was also attending speech therapy on a 1:1 basis weekly. The pediatrician was unable to examine the pt because he became very upset when this was attempted. It was noted that the pt's behavior was better than it was previously, although he still enjoys throwing things around the room, he would look at them for a bit and then throw them. It was noted that the pt walked on tip-toes and his mother stated he tended to do this more at home when he was excited. He would be fairly happy when doing what he wanted to do but screams uncontrollably when one tried to direct his behavior. It was noted that it was only possible to do something with the pt on his own terms and he really didn't like it if one tried to get him to do some task. The pediatrician noted that the pt may lie on the autistic continuum in the aspects of his behavior that was observed in the clinic. It was suggested that the pt have some routine blood tests. Info from the pt's medical record on 09/10/96, noted that the pt was diagnosed as having autism. It was ntoed that the pt's mother was quite concerned after having spoken to other people of autistic children as they commented that he had not had testing for allergies particularly as he was an asthmatic and had eczema. He also had a cousin who had a severe nut allergy. It was recommended tha tthe pt be seen and advised as to whether or not he had a nut allergy. The pt had "only very mild asthma" which was controlled with albuterol as needed. It was noted that the pt's past medical history was significant for : on 02/27/93, the pt had pharyngitis that was treated with Calpol, on 03/09/93, the pt had an upper respiratory infection and on 04/17/93, it was ntoed that the pt's elimination was "not alright." On 11/15/93, the pt had bilateral tear duct blocked and a rash on his face which was noted to be worsening. On 04/06/1994, the pt had upper respiratory infection. On 07/26/94, the pt's mother was concerned that his tonsils were large and the right was greater than the left. It was determined that the pt had normal large not-infected tnsils. On 09/08/94, it was noted that the pt had a fever at night. On 12/11/95 and 12/18/95, the pt was seen by a clinical psychologist who noted that the pt was born by normal delivery at term and there were no neonatal problems or significant illnesses. There were no hearing concerns. Theh pt was seen on 12/06/95 by an orthoptist and was ntoed to have adequate functional vision, but it was not possible to check him for refractive errors. It was ntoe dtha thte pt has an olde sister who had no concerns. It was reported that the pt's developemnt was normal until around 2 years of age when his behavior became extremely difficullt. His speech had platesued at this time. It was noted that his behavior was "now improving," there was less running off and the pt was showing more interest and tolerance of other people. He still continued to be very active and like to play on his own, but would accept his mother playing engaging in play. The normal family outings were resumed, however the pt's behavior remained unpredictable. The pt was tried at two playgroups and a private nursery; however, he was unable to cope. He was now settled in his present nursery and was noted to join in for story, sat with the other children, palyed alongisde, wanted to know their names and would stroke their heads. Apart excellent memory. The pt was seen over two occasions, once iwth his mother and once with his father. The pt was more cooperative with his father. TWo non-verbal subscales and interactional play formed the basis for these sessions. Info from the video of father/child play was also used. It was noted that speech and language have shown a marked improvement over the last six months. The pt now had a wide vocabulary of single words and had linked speech. He could verbally request with mainly single words. His speech seemed ot be rather stereotyepd an dlacked flexibility. Occasionally his speech was inappropriate. He copied words readily and echoed where he did not undersntad. he found questions difficult to respond to, except of "what's that," he was very comfortable with naming activities for pictures and colors. Sometimes his speech was unclear. He was starting to use personal pronouns in speech. His social communicaiton was inconsistent. He could show good interactional skills using appropriate gaze switching and shared pointing combined with speech. At othe rtimes the pt's eye contact was poor, and he would ignore interactions from others. He liked to be in control and would await reactions to provocative behavior. He did respond to clear firm directions, particularly from his father. He was seen to respond to praise. He generally showed low tolerance of frustration. He found it difficult to watch demonstration of activity. There as some very mild lining up in play, and some mild perseveration of play was also noted. N 08/18/1993 08/18/1993 0 UNK UNK UNK UNK Anorexia, irritability, pallor, thirst increased, pharyngitis, upper respiratory infection, functional intstinal disorder WAES99032015 1
0175294 09/14/2001 FL 39.0 35 M This patient had a sudden onset of Facial weakness and weakness affecting the left side of his body, approximately 90 days after vaccination. Prompted complete medical work up and disability retirement by army. Subsequent tests reveal what appears to be a demyelinating syndrome involving both peripheral and central pathways of undetermined etiology. Also tested positive - Autoantibodies against 220-kDa, high and 160-Kda medium weight neurofilament triplet proteins indicating the presence of a disorder affecting the neuromuscular junction. Y N 08/29/1997 01/01/1998 125 Positive - Autoantibodies against 220-kDa, high and 160-Kda medium weight neurofilament triplet proteins indicating the presence of a disorder affecting the neuromuscular junction. MIL UNK NONE Muscular weakness~Vaccine not specified (no brand name)~~30.00~In Patient 1
0175295 09/14/2001 LA 12.0 0 .2 F 09/07/2001 This child had impaired speech, severe mental retardation, and autism. The first six months, she could not sit up alone, and hypotonia. At age eleven we started mercury detox, her symptoms are from mercury poisoning. Y N 10/24/1989 PVT UNK Tuberculine, lot # 250947. NONE 1
0175296 09/14/2001 IL 5.0 5 F 09/07/2001 On 08/21/01, this child got her shots at 9 AM and at 5 PM she got a fever of 99.9. The next morning 08/22/01, she had irregular breathing and it was very labored and she was hoarse and said her body hurt. At 10 AM on 08/22/01, her fever was 100.8, and she had a barking cough along with everything else. On 10/23/01, she got worse, with her breathing and cough. Taken to the doctor on 10/23/01, his diagnosis was bronchospasms that she never had prior to the shot. Y Y U 08/21/2001 08/21/2001 0 PVT PVT Healthy NONE 1
0175297 09/14/2001 IA 0.2 0 .2 M 09/04/2001 The infant had a temp of 101 (R) 72 hours after immunizations. (3) afebrile seizures. 1st 80 hours after immunizations. Y Y 3 Y 08/06/2001 08/09/2001 3 EEG, viral cultures of CSF, stool. CT Scan head, Bacterial cultures, blood, urine, CSF. Herpes PCR on CSF. No infections proven for above studies. PVT PVT Zantac NONE Reflux, premature 36 weeks GA. 1
0175298 09/14/2001 VA 49.0 49 M Vaccine was given 4:10 PM. Onset 4:45 PM, itching soles of feet. At 5:00 PM, ankles and feet were swelling. At 5:15 PM, itching over entire body and swelling feet and wrists. At 5:30 PM, face and mouth numbness with lip swelling. At 5:30 PM, next door neighbor (ER doctor) administers Epinephrine, steroid and 4 Benadryl. He felt better for a while after steroids and Epi. He admits Benadryl makes him restless and drowsy but not sleepy. At 7 PM, he had chest pains with sweating (indigestion type pain in the center of chest). Called neighbor (ER doctor), sent for rescue squad. Taken to ER, IV started, Nitroglycerin. Kept over night. Tests run. Released Saturday 09/01/01, midday. Y Y 1 Y 08/31/2001 08/31/2001 0 Several EKG- Wnl. Blood Enzymes x 2. C-Xray. Stress test in AM. PUB PUB NONE NONE NONE 1
0175299 09/14/2001 NC 0.2 0 .2 F 08/23/2001 06/07/01, this infant had a reaction, she was asleep gurgling, went limp, and not breathing, was aroused by the baby sitter (one time episode) on Thursday at 2 PM once on Sunday at 7 PM, 06/10/00. Y Y Y 06/06/2001 06/07/2001 1 EEG PVT PVT NC01080 1
0175300 09/14/2001 TX 0.3 0 .3 F 08/30/2001 This patient had "choking / aspiration" spell at home about 5-6 hours after immunization. She was not breathing well, turned pale with perioral cyanosis. EMS called. Infant recovered before reaching ER. Y Y 1 Y 08/23/2001 08/23/2001 0 CBC, U/A, and BMP all normal PVT PUB NONE NONE 1
0175301 09/14/2001 NY 2.5 2 .8 F 08/27/2001 HSP diagnosed after noting purpuric rash, fever, joint pain, appetite decrease, abnormal complaints, elevated platelet count, low hemoglobin. Y U 04/03/2001 04/07/2001 4 (-) U heme, nl BUN PUB OTH albuterol Mild URI symptoms. RAD mild intermittent. 1
0175302 09/14/2001 WI 0.2 0 .2 F 08/14/2001 On 3/28/01, the child had a temperature of 99F and cold symptoms. She received vaccines at health dept and later in the evening she developed a fever of 101F-103F. She was taken to the hospital and dx'd with pneumonia and otitis. Hospitalized for 2 days with complete recovery. No problems after 4 month shots on 5/25/01. Y 2 Y 03/28/2001 03/28/2001 0 PUB PUB NONE Cold symptoms and temperature of 99F NONE ~Vaccine not specified (no brand name)~3~0.50~In Sibling WI0129 1
0175303 09/14/2001 UT 0.2 0 .2 F 08/07/2001 This infant had lethargy, was vomiting, irregular breathing (periodic) symptoms started 3 days after vaccination. Hospitalized to rule out sepsis. All ex (-). Got antibiotics for 48 hours. Cousin had same reaction after 4 mos shot, same lot number. Vaccine of HiB and DTaP. Y 2 Y 08/02/2001 08/05/2001 3 Tests - Negative (-). PVT PVT NONE NONE NONE 1
0175304 09/14/2001 WA 1.0 1 .0 F 09/04/2001 Bruising noted 08/31/2001. Evaluated 09/01/01, platelet count 0. Diagnosed with idiopathic thrombocytopenic purpura. Hospitalized for IVIG infusion. Y Y 08/08/2001 08/31/2001 23 PVT PUB NONE URI, otitis media 08/13/01. 1
0175305 09/14/2001 NY 10.0 1 .4 M 08/30/2001 Vaccine- strain measles viral infection. Seizure and convulsion within hours. Constant diarrhea, within hours and continues until the present. Loss of speech, change in eating habits and personality. The annual follow-up states "diarrhea, not talking at all, not relating understanding, mental retardation, allergy symptoms severe." Y N 12/19/1992 12/19/1992 0 Extremely high titers of mumps, measles, and rubella. Continues to the present. PVT PVT NONE Possible ear infection. NONE 1
0175306 09/14/2001 FL 1.25 1 .2 M 09/05/2001 Multiple polymorphous erythematous lesions generalized with some target lesions with central clearing consistent with erythema multiforme. U 08/28/2001 09/04/2001 7 NONE PVT PUB NONE NONE NONE 1
0175307 09/14/2001 CA 1.0 1 .0 M 09/04/2001 Post varicella vaccine lesions on torso and neck. Y U 08/21/2001 08/30/2001 9 NONE PVT PVT NONE NONE NONE 1
0175308 09/14/2001 OH 0.3 0 .4 M 09/08/2001 Pt's left leg was red, swollen, warm to touch with a hard area around the injection site. Y 09/07/2001 09/08/2001 1 PVT UNK NONE NONE NONE 1
0175309 09/14/2001 TX 2.0 2 .5 F 08/27/2001 Mother stated that she took child to clinic on 8/26/01 for redness at the injection site and swelling. Child was placed on Keflex. Y Y 08/24/2001 08/26/2001 2 PUB PUB URI with cough and right serous OM NONE 1
0175310 09/14/2001 MI 3.0 3 F 08/22/2001 2 hours, post vax, pt complained of sore throat. 4 hours, post vax, pt had hives on left side including back, arm and leg. She was given Benadryl by mom after consulting with MD. Y Y 08/17/2001 08/17/2001 0 PUB UNK NONE NONE MI2001065 1
0175311 09/14/2001 NY 0.3 0 .3 F 09/06/2001 Pt's temperature went up to 102.7F, 24 hours, post vax. Y 08/28/2001 08/28/2001 0 PVT PUB NONE NONE 1
0175312 09/14/2001 WA 1.3 1 .3 M 09/05/2001 After 1 dose of DTAP and HIB administered, child pulled away and immunization was administered onto the floor. Fresh doses were drawn by MA and given without problem. The other 3 doses were without incident. Onset of urticaria, 10 days, post vax, lasting 3 weeks to date. Hives are ongoing to date. U 08/03/2001 08/13/2001 10 NONE PVT PUB NONE NONE NONE 1
0175313 09/14/2001 CA 0.2 0 .2 M 09/04/2001 Pt developed a swollen, red and painful left thigh. Y 08/21/2001 08/21/2001 0 NONE PVT PVT NONE NONE NONE 1
0175314 09/14/2001 PA 1.5 2 .1 M 08/31/2001 Pt developed a marked swelling and wheal (10cm circle), warm to touch and a noticeable limp. U 08/29/2001 08/30/2001 1 PVT PVT NONE 1
0175315 09/14/2001 MI 0.75 0 .8 M 08/30/2001 Pt developed acute swelling and discoloration of entire portion of both legs. He also had extended crying the entire day. Y Y 08/29/2001 08/29/2001 0 NONE PVT PUB NONE NONE NONE 1
0175316 09/14/2001 TN 1.8 1 .8 M 08/29/2001 Mother in for 2nd Prevnar. Told us that child started having irritability and fussiness early the next morning. She stated that the child cried often, very fussy and would only sleep about 2 hours at a time, at night. Symptoms lasted 3 days. No fever. Due to the extent and length of the irritability, she deferred 2nd immunization. Y 06/19/2001 06/20/2001 1 NONE PUB PUB NONE NONE NONE TN01043 1
0175317 09/14/2001 GA 3.0 3 F 08/29/2001 As the mother was bathing the child on 8/28/01, she noticed the left deltoid "swollen, red and hot to touch". The child was irritable and had a low-grade fever. She carried her to the ER where she was given treatment with Benadryl and ice packs. On 8/29/01, the arm site was "warm" with some redness but improved. Y Y 08/27/2001 08/28/2001 1 NONE PUB PUB NONE NONE GA01081 1
0175318 09/14/2001 GA 2.0 2 .2 M 08/17/2001 Mom contacted HD staff on 8/15/01 at 16:45, stating that the child was nauseated and vomiting, fretful and crying and with a temperature of 101F-102F since morning. Denies any edema or redness at injection site. Phone call on 8/17/01 to mom reveals that child is having no problems. Y 08/14/2001 08/15/2001 1 NONE PUB PUB NONE NONE NONE GA01078 1
0175319 09/14/2001 HI 0.3 0 .3 M 09/05/2001 Pt was given his 4 month shots without incident. Both extremities had patches of red and according to her mom, it was swollen up later X 1 week. The doctor seen the baby and Rx'd hydroxyzine and Tylenol. No redness at this time. Pt had the same symptoms at his 2 month shots and was seen by a doctor but MD wasn't sure if it was caused by the vaccine or something else. Y 09/05/2001 09/05/2001 0 MIL MIL NONE UNK 1
0175321 09/14/2001 WI 1.2 1 .3 F Localized erythema and swelling at injection site on right leg. Seen at ER on 7/15/01. Y Y 07/13/2001 07/17/2001 4 PUB OTH NONE WI0128 1
0175322 09/14/2001 AZ 0.75 0 .8 F 09/06/2001 On 8/29/01, mother noted redness and hives around the injection site, progressing to hives all over the child's body, over the next 8 days. Seen today in the clinic. No other explanation for urticaria. Rx'd Benadryl. Y 08/27/2001 08/29/2001 2 NONE PUB PUB NONE NONE NONE 1
0175323 09/14/2001 CA 1.3 1 .3 F 08/30/2001 Pt developed a febrile seizure. Y Y 08/23/2001 08/23/2001 0 PVT PUB NONE NONE CA010090 1
0175324 09/14/2001 PA 4.0 4 F 08/29/2001 Redness, tenderness, swelling and warmth (localized) at DTAP and Prevnar sites. U 08/23/2001 08/25/2001 2 NONE PVT PVT NONE NONE NONE 1
0175325 09/14/2001 MS 0.6 0 .6 F 08/27/2001 Infant started having increased temperature on Saturday. On Sunday, at 02:00, it was 104.1F and infant was taken to ER and seen by a doctor. He Rx'd Cefzil 125mg bid X 10 days. No otitis, only pink TM and no other abnormal findings. Temperature today is 101.2F and taken to PMD and stated probably DTAP and to only give Cefzil X 5 days. Mother to consult PMD and get note on what vaccine is ok for next visit. This child was adopted. Y Y 08/24/2001 08/25/2001 1 PUB PUB NONE MS01037 1
0175326 09/14/2001 GA 3.0 3 M 09/10/2001 Within 4 hours of Prevnar, pt awoke with a temperature of 103.7F and was given Tylenol and Motrin. Eight hours, post vax, he had generalized tonic-clonic seizure associated with alteration in level of consciousness. Seizure lasted 1-2 minutes and was not with respiratory distress. Pt went to sleep after seizure and awoke without fever. The next morning he was back to baseline. (Pt has abnormal neuro status even at baseline-mainly abnormal behavior and development and is being referred to a neurologist). Also mom notes there was redness and soreness at the injection site for 2 days. Y 07/26/2001 07/26/2001 0 NONE PVT UNK Depakote Developmental delay, seizure disorder and polydipsia 1
0175327 09/14/2001 MI 4.0 4 F 08/22/2001 Mom reports redness, swelling and warmth to all (4) sites which started the same day and is continuous at the present time. She noted discoloration to both arms approx. 1 week, post vax, with left arm approx. (2 1/2"-3") and right arm approx. (1") with red/purple colored circled area around injection sites. Client was taken to the doctor on 8/3/01 and was treated with antibiotics. Discoloration continues to be rechecked by doctor on 8/31/01. Note: Diluent/MSD/1707R/SC/RA/1 previously. U 07/26/2001 07/26/2001 0 PUB UNK NONE NONE Reports a history of asthma with upper respiratory illnesses (only) MI2001062 1
0175328 09/14/2001 OH 0.3 0 .3 M 08/21/2001 At 23:45, on 8/20/01, the baby vomited stomach contents and continued vomiting until it was pink streaked bile-like substance. Parents took baby to ER at approx. 01:00 on 8/21/01. The baby was limp and dusky in color. While waiting in ER, child returned to normal state. Discharged home with parents. Y Y 08/20/2001 08/20/2001 0 PVT UNK NONE NONE NONE 1
0175329 09/14/2001 MA 55.0 54 F 09/08/2001 Pt received primary series of Lymerix on 3/2/00, 4/4/00 and 5/1/00 with adverse reaction. She received booster on 4/26/01 and developed polyarthralgia/arthritis with intermittent fever (generally 99F-100F but as high as 103.5F on 1 day) starting in mid June, 2001. I have not seen her since vaccination. Got information by phone. Ongoing symptoms. Not responding to Motrin or glucosamine. I do not have copies of lab data or medical records re this reaction; am depending on information provided by pt by (phone). Y N 04/26/2001 06/18/2001 53 Pt reported by phone that ANA "slightly (+)"; ESR 79 PVT UNK hydrochlorothiazide NONE Hashimoto's thyroiditis (can be associated with (+) ANA) 1
0175330 09/14/2001 VA 67.0 67 F 09/05/2001 Pt had 4 vaccines for overseas travel at about 11:00 on 8/31/01 (Typhoid VI, Hep-A, IG-IM and Pneumococcal PS). She received Hep-A, IM and Pneumococcal PS, SC in her left arm. Pt developed a temperature up to 101.8F by 00:01 on 9/1/01 with 50 cent-sized erythema and induration and body aches. Temperature resolved by later on 9/1/01 with Tylenol use. Still had erythema over 1" on 9/4/01, but by location, reaction likely due to pneumococcal vaccine. Y 08/31/2001 09/01/2001 1 PUB OTH HCTZ, Zocor, Tetracycline for Rosacea; Gefbrizol; ASA; Celebrex; Altace; Vitamin E, C & Multivitamins; Ca supplement; Synthroid NONE Allergy to Penicillin; HTN; High cholesterol and triglycerides; Hypothyroidism VA01037 1
0175331 09/14/2001 MI 4.0 4 F 08/24/2001 At the present the child s with her mother at the clinic for evaluation of her left thigh (ant) injection site. Complains of pain for 24 hours post-immunization, no redness noted by mother. Complained of pain this AM, "limping" slightly, "leg is red" per mom. Area of erythema and induration measuring 8 cm x 11 cm assessed; skin intact and non pruritic. Advised eval by Primary Physician, warm compresses, non-chafing clothing. PHN will F/O next week. U 08/22/2001 08/24/2001 2 PUB PUB MI2001059 1
0175332 09/14/2001 MI 4.0 4 M 08/22/2001 Pt complained of red, blotchy face starting the morning after vaccines received. No hives or rash elsewhere on body. No difficulty breathing. Activity is normal. U 08/21/2001 08/22/2001 1 UNK UNK NONE NONE NONE MI2001060 1
0175333 09/14/2001 MI 43.0 43 M 08/22/2001 On 08/20/01, pt called stating that he received TD on 8/16/01 and the next day awakened with body aches, fever, chills, diarrhea and "felt sick all over". Took Tylenol but temperature remained about 100F on Saturday and Sunday. He had some improvement on 8/20 but was concerned on 8/18/01 and 8/19/01 about symptoms related to TD shot. He was referred to PMD for assessment. Y U 08/16/2001 08/17/2001 1 PUB PUB MI2001064 1
0175334 09/14/2001 OH 70.0 70 F 09/06/2001 7 hours, post vax, the pt's left upper arm had large edema, redness and warmth lasting during the night. In the AM, she still had edema, redness and warmth continuing through 2 days. Temperature was 98.2F. U 09/04/2001 09/04/2001 0 PVT UNK 1
0175335 09/14/2001 MI 4.0 4 M 09/07/2001 Gave 2nd DTAP, 2nd Polio, 2nd MMR and 3rd Hep-B. Y U 09/07/2001 09/07/2001 0 PUB PUB NONE NONE Allergic to penicillin 1
0175336 09/14/2001 TX 16.0 16 F 08/30/2001 Hives on face on 8/28/01. Hives on the hand and bottom of her feet on 8/30/01. Mom spoke to doctor first and he told her to start pt on Benadryl. The mother had a call into doctor about the rash spreading to the pt's feet and hands and was waiting on a call back from the doctor. U 08/27/2001 08/27/2001 0 OTH PUB PPD/Aventis/C0866AB/ID/LFA/0 previously NONE NONE 1
0175337 09/14/2001 MI 7.0 7 F 09/07/2001 Pt developed a red, raised area around the injection site on left thigh. U 08/20/2001 08/23/2001 3 PVT PVT NONE 1
0175338 09/14/2001 FL 29.0 29 F 09/09/2001 Pt relates she was sitting and bumped her knee on a metal table. She leaned forward and then everything went black. She was assisted to the floor with head and neck support maintained. The assistant that helped her, stated that she had her eyes open and was limp and also she had an episode of about 4 seconds of whole body shaking. Pt relates that all tests done in ER were negative and her vital signs were normal, including her temperature. She states that she felt light-headed when she came around and only complained of left deltoid soreness with palpation. Denies any history of seizures or past syncope. Dx'd at ER with vasovagal reaction. Y Y 09/08/2001 09/08/2001 0 Brain CT; CXR; Chemistry; IV Blood work-all WNL MIL MIL NONE NONE Tonsillectomy 1
0175339 09/14/2001 MI 1.0 1 .0 F 09/07/2001 Pt developed erythema multiforme minor with temperature of 103.5F which resolved by 8/20/01. She was given Biaxin on 8/14/01 for possibility of Mycoplasma infection. Y Y 08/03/2001 08/13/2001 10 UNK PVT PVT UNK Diarrhea (mild) for 1 week UNK ~Measles + Mumps + Rubella (no brand name)~1~1.00~In Sibling 1
0175340 09/14/2001 NJ 1.25 1 .3 F 09/10/2001 Pt developed a fever of 103F on 8/29/01 and had seizures and was taken to ER for evaluation. Y Y 08/15/2001 08/29/2001 14 UNK PVT PVT NONE NONE GER, resolved 9/00 1
0175341 09/14/2001 OH 1.08 1 .1 F 09/05/2001 A 13 month old healthy girl developed red, papular rash with vesicles from head to toe which started on 9/2/01. She was seen in my office and she had about 30-40. She was not ill, not pruritic and had no URI symptoms or fevers. Y U 08/20/2001 09/02/2001 13 NONE PVT PVT NONE NONE 1
0175342 09/14/2001 TX 4.0 4 F 09/06/2001 Pt developed a 6" X 5" induration with warmth to the right thigh. Y 08/21/2001 08/22/2001 1 NONE PVT UNK URI; no fever NONE 1
0175343 09/14/2001 SC 4.0 4 F 09/06/2001 24 hours, post vax of school shots, pt complained of painful lips and marked edema of bilateral lips and bilateral hands and wrists and all 4 eyelids. Presumed recovery. Y 09/04/2001 09/05/2001 1 Physical exam on 9/6/01 PVT PVT NONE NONE NONE 1
0175344 09/14/2001 CA 4.0 4 F 09/05/2001 9 days, post vax, pt developed rash on thigh and buttocks and foot. Y 08/21/2001 08/30/2001 9 8/30/01 had viral culture-varicella zoster virus OTH UNK 1
0175345 09/14/2001 GA 1.0 1 .0 F 07/20/2001 Pt developed a fever (mom does not know how much) and a rash, starting at both thighs and spreading to the body, 1 hour, post vax. The fever was controlled with Tylenol per mom. Pt seen by MD on 7/10/01 and was prescribed Atarax. Y Y 07/09/2001 07/09/2001 0 NONE PUB PUB NONE NONE NONE GA01083 1
0175346 09/14/2001 GA 51.0 51 F 08/30/2001 Pt states that within 4 hours, post vax, she became extremely dizzy, had nausea and vomiting and almost passed out at school. She was taken home and seen in the clinic the next morning. Her BP in the clinic was 166/106. She also complained of severe headaches, dizziness and weakness. Pt was seen by doctor the same day and given samples of BP medication. She returned to the doctor on 8/30/01 and was given Antivert for dizziness. BP was 140/80 at clinic on 8/30/01. Y Y 08/27/2001 08/27/2001 0 NONE PUB PUB NONE NONE NONE GA01082 1
0175347 09/14/2001 GA 4.0 4 F 08/23/2001 The mother reports to HD this morning with a complaint of left deltoid redness, swelling, itching with fever to site. Mother phoned ER on 8/22/01 PM and was instructed to use ice packs; child assessed on 8/23/01 at 08:18 AM here at DCHD and instructed to use ice packs and contact MD tomorrow if none better. Appears to be a local reaction; no signs or symptoms of septicemia at this time. Y U 08/21/2001 08/21/2001 0 PUB PUB NONE NONE GA01080 1
0175348 09/14/2001 GA 4.0 4 M 08/20/2001 Pt's left arm was swollen and hot to touch and red. Y 08/08/2001 08/08/2001 0 PVT UNK NONE GA01079 1
0175349 09/14/2001 GA 5.0 5 F 08/14/2001 Mom stated that child complained of soreness in right arm on 8/10/01 AM and 8/11/01 AM. Right arm was swollen and very red from shoulder to elbow. The pt had blisters and itching. Child was taken to ER on 8/11/01 and was given hydrocortisone and advised to apply cool compresses to arm. Denied having increased temperature. Arm was much improved by Monday and child returned to school. Y Y 08/09/2001 08/10/2001 1 PUB PUB NONE NONE NONE GA01077 1
0175350 09/14/2001 GA 23.0 23 F 08/09/2001 Pt into clinic with complaint of reaction to MMR given on 8/7/01. She states it is "very painful"; has not used any comfort measures or taken anti-inflammatories as yet. On 8/8/01, she states that site was itching and she scratched the area. It became red and painful to touch during the day with worsening overnight, last night. She awoke this AM and noticed increased swelling and redness with increased pain. It was noted that the size of the reaction was approx. less that the size of a quarter initially with swelling and redness around site approx. 1/2" to 1" surround area. It was noted that there was a 22mm reaction noted at site with 1/2" to 1" of redness surrounding site. Instructed pt to immediately begin taking ibuprofen or Tylenol every 4-6 hours until pain resolved and apply warm compress to area. Instructed client to report to ER or PMD if symptoms worsen. Assessment and consultation performed by LPN and RN. Y U 08/07/2001 08/09/2001 2 PUB PUB Asthma and a history of previous reactions of unknown sources. GA01076 1
0175351 09/14/2001 GA 2.0 2 .3 F 06/26/2001 A 2 year old received DTAP on 6/22/01. Mom states she noticed redness and swelling on 6/24/01. The left deltoid area was red, hard, swollen and hot to touch. Approx. size of a coke can. Encouraged mom to apply cool cloths and continue Tylenol for discomfort. Y 06/22/2001 06/24/2001 2 PUB PUB NONE NONE GA01075 1
0175352 09/14/2001 GA 5.0 5 M 08/01/2001 Pt developed a red rash on abdomen and groin area that itches. Sign and symptoms began on 8/1/01. U 07/30/2001 08/01/2001 2 NONE PUB PUB NONE NONE NONE GA01073 1
0175353 09/14/2001 GA 5.0 5 M 08/03/2001 On 8/3/01, pt's left arm became red and swollen about 15:00 today. Advised to use cold compresses today and warm compresses tomorrow and Tylenol for pain. U 08/02/2001 08/03/2001 1 NONE PUB PUB NONE NONE NONE GA01068 1
0175354 09/14/2001 MN 9.0 0 .2 F 09/04/2001 On 9/1/01, this young girl came in and has a red, itchy rash on her arms and upper thighs. She stated "I think it was from my Hep-B shot". Treatment: given 50mg, IM, of Benadryl. Y Y 08/31/2001 08/31/2001 0 PVT PVT NONE Asthma 1
0175355 09/14/2001 WI 5.0 5 M 09/07/2001 Pt developed a 8cm X 4cm red, warm indurated and swollen area on left upper arm, 48 hours, post vax of DTAP. Y U 09/05/2001 09/07/2001 2 PVT UNK 1
0175356 09/14/2001 NY 4.0 4 F 09/07/2001 Pt developed a 4cm X 7cm raised, red area on left shoulder, tender, warm and indurated. U 09/05/2001 09/06/2001 1 NONE PUB PUB NONE NONE 1
0175357 09/14/2001 NV 9.0 9 M 09/06/2001 Mother describes pt complaining of a rash all over his body. Upon examination, child was found to have red papules over torso and face/head. Denies itching. Afebrile. Denies difficulty breathing on 9/5/01, but states child did complain of difficulty catching breath on 8/29/01. No medical treatment sought. U 08/28/2001 08/29/2001 1 NONE PUB PUB NONE NONE NONE 1
0175358 09/14/2001 VA 5.0 5 F 09/04/2001 Hives, fever and rash developed 2 days, post vax. Pt also complained of tightness in chest. Mom called nurse triage then was advised to give Benadryl and go to ER. Atelectasis in chest improved with steroids and antibiotics. Y Y 08/31/2001 09/01/2001 1 CXR-showed atelectasis PVT PVT NONE Egg allergy and asthma 1
0175359 09/14/2001 NY 43.0 43 F 09/07/2001 Pain in shoulder; cannot lift arm. N 08/14/2001 08/15/2001 1 OTH UNK Mantoux/Parkedale/00341P/ID/RFA 1
0175360 09/14/2001 NY 1.25 1 .2 M 09/06/2001 Pt presented to office on 8/28/01 with varicella. Y Y 08/20/2001 08/26/2001 6 PVT PUB NONE OM in 3/01 1
0175361 09/14/2001 AR 42.0 42 F Pt developed body aches, redness and cellulitis at the injection site. Also, had flu-like symptoms. Y Y 08/27/2001 08/27/2001 0 MIL MIL NONE Diabetes 1
0175362 09/14/2001 MT 5.0 5 M 08/28/2001 Pt developed redness, swelling and hives on arm. He also had lethargy and loss of appetite. Parent was instructed to give Benadryl and Tylenol with good relief reported, 48 hours, post vax. No further adverse problems. Mother concludes 3-4 X family history of tetanus allergy. Y 08/21/2001 08/22/2001 1 NONE PUB OTH NONE NONE NONE 1
0175363 09/14/2001 NE 51.0 5 F Pt developed a swollen left thigh; mottled and red; leg was 3cm larger in diameter than the other leg. Swelling noted on 8/1/01. Y Y 07/30/2001 08/01/2001 2 NONE PVT UNK NONE NONE NONE NE004 1
0175364 09/14/2001 PA 4.0 4 M 08/30/2001 Pt's left arm developed swelling with erythema (large swelling of upper arm) and red on 8/30/01, about 48 hours, post vax. Treated with Tylenol. Y 08/28/2001 08/30/2001 2 NONE PUB PUB Albuterol prn NONE Developmental Delay; Recurrent OM; RAD 1
0175365 09/14/2001 FL 35.0 35 F 09/04/2001 Pt experienced scattered red and itchy blotches on face, arm and abdomen X 5 during the past 4 days that lasted for a few hours, the resolved. Benadryl taken for relief. U 08/28/2001 08/28/2001 0 NONE OTH OTH NONE NONE NONE 1
0175366 09/14/2001 HI 1.0 1 .0 F 08/31/2001 Infant received MMR and Varicella vaccines on 08/20/01. On 08/27/01, she developed a rash spreading over her body. On 08/29/01, developed fever of 102.2; by 08/31/01, rash and fever resolving, but vomiting from 08/30/01 - 08/31/01. Y Y 08/20/2001 08/27/2001 7 NONE PVT PUB NONE NONE Partial anomalous pulmonary venous return. 1
0175367 09/14/2001 RI 4.0 4 F 09/06/2001 Received Varivax on 08/24/01. Rash on trunk and extremities smaller than chicken pox developed 09/03/01, fever of 104 on 09/05/01. Y N 08/24/2001 09/03/2001 10 PVT PUB NONE NONE 1
0175368 09/14/2001 MS 13.0 13 M 08/30/2001 Vaccine administered 08/28/01. Came to the Health Dept again on 08/30/01, wanting a doctors excuse, says "can't move arm", "swollen", no "feeling in arm and shoulder". No visible swelling, no local reaction resides holding forearm bent. Sent to PMD. Y Y 08/28/2001 08/30/2001 2 PUB PVT NONE NONE NONE MS01038 1
0175369 09/14/2001 NY 12.0 12 M 09/06/2001 This child had a temperature of 100 - 103 with nausea. One week after Hep B # 3 on 08/29/01. Per mom similar symptoms occurred after Hep B #1 09/23/93, # 2 12/16/93. Parents very anxious, they feel this is an adverse reaction. The physician feel illness is concurrent with viral illness in community. Y 08/29/2001 09/04/2001 6 PVT PVT NONE NONE Temperature and nausea.~Hep B (no brand name)~1~0.00~In Patient 1
0175370 09/14/2001 MA 44.0 46 F 09/05/2001 Approximately 5 days after administration; this patient a woke 5 AM with "hive and welts" allover her body, from her neck down. She took a Benadryl later dissipated. Occurred again on 09/04 and 09/05 AM. Each time "hives and welts" on her legs each time took Benadryl. No SOB, tongue numbness, swelling, itch. Y 08/21/2001 08/26/2001 5 NONE PVT UNK NONE NONE 1
0175371 09/14/2001 NJ 1.5 1 .5 M 08/29/2001 Had DTaP vaccine on 08/27/01. Redness on 08/28/01. 08/29/01, area of erythema around injection. No systemic reaction. U 08/27/2001 08/27/2001 0 UNK UNK 1
0175372 09/14/2001 WV 23.0 23 F 08/28/2001 Tubersol was given in the right forearm. Then Hepatitis B was given IM in the left deltoid. The patient was complaining of nausea immediately. Approximately 40 seconds later nonresponsive. Epi pen was given. The patient did respond to questions approximately 15 seconds after epi given. Sent to the ER. Appeared to be a seizure. U 08/28/2001 08/28/2001 0 UNK UNK Tubersol-Aventis Pasteur C0619AA Denied yeast allergy. 1
0175373 09/14/2001 NC 4.0 4 F 09/13/2001 This child had erythema. edema, warmth, and pain at the site of injection. Low grade fever. Y U 09/11/2001 09/13/2001 2 UNK UNK 1
0175374 09/14/2001 ME 4.0 4 F 09/13/2001 A four year old with a history of prior Tetramune and DTaP immunizations, received a 5th dose of Tetanus and Diphtheria vaccine. Within 24 hours, she developed an 8 cm area of erythema, warmth, and tenderness. No signs of infection. Within 48 hours external reaction stabilized. No signs of infection. U 09/11/2001 09/11/2001 0 NONE PVT PUB NONE NONE NONE Redness and swelling~DTP + Hib (Tetramune)~1~0.00~In Patient ME01034 1
0175375 09/14/2001 NC 5 F 09/12/2001 This child had a very large red rash on her left anterior thigh, raised, hot, tender, measures 15 cm wide x 8 cm tall, indurated. Was at the site of DTaP and IPV injections, 2 days previous. U 09/10/2001 PVT PUB Asthma 1
0175376 09/14/2001 KY 55.0 55 M 08/27/2001 Elevated temp, dizzy, and nauseated on 08/23/01. On 08/27/01 in the AM, this patient came into the office complaining of nausea, diarrhea since the evening of 08/23/01. He was seen in the ER on 08/26/01, due to weakness and diarrhea. On 08/27/01, phone call, patient was seen by the doctor due to severe weakness, nausea, and diarrhea this PM. Y Y 08/22/2001 08/23/2001 1 PUB PVT KY2001059 1
0175377 09/14/2001 WI 1.0 11 M 08/20/2001 Acute chest pain, fever approximately 30 minutes after 2nd Hepatitis B shot. R/O allergic reaction to Hepatovax. Advised not to get Hep third shot until discussing with MD. Y Y 08/16/2001 08/16/2001 0 PUB PUB NONE NONE WI0130 1
0175378 09/14/2001 OH 18.0 18 F 09/06/2001 The patient is an 18 year old who originally got a TB shot and a Hepatitis B shot a couple of days ago and since then she has had loss of taste on half of her tongue and her eyes are not closing right. Her face is all twisted and her mouth is twisted. The patient shows classic signs of Bell's Palsy on the right side of her face, loss of taste on half of her tongue and a seventh nerve distribution. Y U 08/30/2001 08/30/2001 0 PUB PUB Metronidazole (flagyl) Trichomonas Vaginitis NONE 1
0175379 09/14/2001 LA 1.2 1 .2 M 08/31/2001 Elevated temp of 102.5, highest elevated temp. On 08/28/01, received immunizations x 7. Tuesday at 3:30 PM elevated temp and seizure at 1:30 PM on 08/29/01 to ER. Y Y 08/28/2001 08/29/2001 1 PUB UNK Acid reflux, allergic to milk. 1
0175380 09/14/2001 MS 1.7 1 .0 F 09/06/2001 No adverse event. Patient developed chicken pox 9 months after receiving immunization. Y Y 01/04/2001 09/05/2001 244 PVT PUB NONE NONE NONE 1
0175381 09/14/2001 VA 3.0 3 M This child's arm was swollen from shoulder to elbow. Had vaccination in the morning, swelling noted in the afternoon and redness noted with elevated temp of 105. Given Tylenol which brought fever decreased, also given ice to swollen area. U 08/07/2001 08/07/2001 0 PUB UNK Asthma inhaler NONE Asthma 1
0175382 09/14/2001 KS 47.0 47 F 08/16/2001 On 08/07/01, started with Headache then her eyes started swelling. Her right arm started hurting and got swollen around 5 PM day of vaccine. Also had "upset stomach". Given Naprosyn for pain and IM Benadryl, on 08/08/01 followed by po Benadryl. Y U 08/07/2001 08/07/2001 0 NONE PUB PVT NONE 1
0175383 09/14/2001 IL 1.7 1 .7 M 08/29/2001 On 08/29/01, mom indicating she and the doctor questioning a reaction to immunizations given 08/08/01. Eight days after he was lying in bed and started shaking (trembling-like), was crying. He could not sit or stand, he was taken to the ER, he was walking okay and then he stopped. He started shaking and fell over again later while in the ER. No further problems since. Having EEG 08/30/01. Y Y 08/08/2001 08/16/2001 8 PUB PUB IL01034 1
0175384 09/14/2001 MI 2.0 2 .9 F 09/06/2001 This patient received DTaP / Hib combination on 09/04/2001 in the left thigh. By PM of 09/05/01, noted local reaction over the thigh. Seen afternoon of 09/06/01. Had 14 x 10 cm erythematous, warm local reaction, indurated on anterior lateral aspect of the thigh. Not painful, not limiting activities. U 09/04/2001 09/05/2001 1 Physical exam PVT PUB NONE NONE NONE 1
0175385 09/14/2001 IA 5.0 5 M 09/10/2001 Given children's Motrin at 10:30 AM and at 7:30 on 08/08/01. At 3:00 AM on 08/09/01, this child had a fever of 103 (oral), a fine rash on his body and vomited. The mother reports fever gone in 48 hours, rash gone in 5 days. Her doctor told her he felt it was not from the vaccine. Y 08/08/2001 08/09/2001 1 PUB PUB NONE NONE IA01011 1
0175386 09/14/2001 AK 0.3 0 .3 F 07/15/2001 This infant had a rash all over her back, stomach, arms, and legs. Y 07/23/2001 07/24/2001 1 OTH PUB NONE AK200153 1
0175387 09/14/2001 TX 4.0 5 F 08/29/2001 This child had elevated temp, and hives 4 hours after the vaccines. Child was taken to the ER. Y Y 08/08/2001 08/08/2001 0 PVT PUB NONE NONE 1
0175388 09/14/2001 CA 6.0 6 F 09/06/2001 This child had cellulitis approximately 3 - 3 1/2 inches at the injection site, redness clearly marked, hot, and tender. No induration. Antibiotics - Keflex prescribed. Left arm injection site - either the DTaP or IPV. Cellulitis now gone. Y Y 08/31/2001 09/02/2001 2 NONE PVT UNK Unclassified PPD, left forearm, 1 previous dose. NONE NONE 1
0175389 09/14/2001 WA 30.0 30 F 07/30/2001 HBIG given IM at 12:30 PM on 07/23/01, patient had hot rash over arms, chest and legs. Started at 3:00 PM on 07/23/01. Y Y 07/23/2001 07/23/2001 0 PUB PVT Zerit, Epivir Needle stick Kidney problems. 1
0175390 09/14/2001 LA 0.25 0 .3 M 07/16/2001 Per mom's report, this infant started with a high pitched cry, inconsolable for 30 minutes after vaccines. It lasted for about 3 hours. Brought him to the doctor and was given Benadryl and infant Tylenol. No blood work done. Y Y 07/13/2001 07/13/2001 0 NONE PUB PUB NONE Reflux LA010703 1
0175394 09/17/2001 NY 70.0 69 M 09/10/2001 Information had been initially received from a female consumer concerning her 70 year old father who she reported that on an unspecified date in 10/00 was vaccinated in his arm with pneumococcal vaccine 23 polyvalent (dosage, specific site, route and lot number not provided). In 10/00, almost immediately,post vax, the pt experienced pain in his arm. It was indicated that the pt had sought medical attention and subsequently the pt still has experienced pain in his arm. In follow-up, the pt's physician reported that a 70 year old white retired male had been vaccinated on 10/23/00, IM, 1st dose, with an influenza virus vaccine (dosage and specific site not reported, vaccine manufacturer was reported as "Medeva", lot number E65630HA). On 11/7/00, the pt was vaccinated with a 1st dose of pneumococcal vaccine 23 polyvalent, IM (dosage and specific site not reported; lot number reported as 637094/0945K). On 7/14/01, the pt developed back pain, generalized body aches and acute renal failure. At the time, the pt was hospitalized and dx'd with Wegener's granulomatosis. On 8/1/01, the pt recovered. No further information was available. Y Y Y 11/07/2000 07/14/2001 249 Renal biopsy-positive for Wegener's granulomatosis 7/01 PVT PVT Food allergy WAES01071956 1
0175395 09/17/2001 WA 3.0 3 F 09/10/2001 Information has been received from an RN concerning a 3 year old female pt who on 7/17/01, was vaccinated with MMRII. The RN reported than since 8/17/01, her daughter has experienced seizure-like activity on a daily basis. She stated that she has seen everything from a flexing of the toes (almost daily) to a full grand mal seizure. At the time of this report, the pt had not sought medical attention. Upon internal review it has been determined that the grand mal seizure was an "Other Important Medical Event". Additional information has been requested. F/U states the lot number as 634321/1384K and there were no concomitant therapy. An RN in the NP's office, reported that the pt had had previous immunizations with no problems. On 8/18/01, the pt's mother called the office 3 separate times reporting that her baby-sitter has been reporting to her for the past 2 weeks, that the pt has been displaying various shaking of different parts of the body. She remained alert and awake and "looking all around". The 8/18/01 date was the 1st time that the mother had witnessed this while giving the pt a bath. The mother took the pt to a hospital and waited for 2 hours to be seen. The mother noted that nothing was done in the ER. The ER physicians dx'd the pt with seizures and told the mother that her daughter needed to be seen by a pediatric neurologist and have an EEG done. On 8/20/01, the pt's mother called the office to request a referral to the pediatric neurologist for an EEG and a CT Scan. At the time of this report, a pediatric neurologist was currently following the pt. F/U info has been received from a physician which indicated that the child was seen on 9/11/01 by a pediatric neurologist whose impression of the pt was reported as "abnormal movements" that did "not appear to be seizures". Additional info received from an NP confirmed that the child was "not having seizures". No further info was provided. F/U information received from an NP on 11/6/01 indicated that the dose of MMRII noted in this report was the pt's 2nd dose. It was noted that "given the combination of events", the pediatric neurologist planned to do a 24-hour video EEG. Upon internal review, "abnormal movements" was determined to be an "Other Important Medicat Event". Additional information has been requested. Follow up information received from the nurse practitioner indicated that the patient also developed abnormal movements of her face and a tightening of her muscles occurring up to 10 times a day. It was noted that the patient had not experienced any other adverse events following previous vaccination. She noted that a diagnosis of dystonia vs. benign Rolandic epilepsy was proposed. Medical records received from a neurologic evaluation of the patient on 11/19/01 indicated that the patient was referred for an evaluation of possible seizures, and that it was the patient's first neurological consultation in the neurology clinic. The patient, who was on no medication presented with a six month history of episodic intermittent abnormal muscular movements most often in the legs, which someimes involved the arms or the face with muscle contractions. It was reported that the patient in general has been a very healthy child. She was growing and thrivign and her development had been outstanding. It was noted that her movements tend not to happen with exercise or stimuli, and that it tends to happen more often with similar events such as watching TV. It has increased in frequency of the last few months, and now occurs up to 10 times per day. It lasts five to ten seconds, but can last up to 2 to 5 minutes on rare occasion. During the longer events, the patient may become sweaty, and generally does not have loss of consciousness. The patient's father described some events involving the patient's jaw and noted that it was like someone else moving her jaw. During these events, the patient sometimes had her eyes up, and those were the events that lasted somewhat longer. The patient was reported to have excellent athletic abilities and is very verbal. She had not lost any skills and overall did not seem to be too disturbed by this whole process. It was noted that the patient was the product of full-term gestation, there were no birth complications. Apgar scores were normal, and no jaundice, infections or other significant problems were observed. Her early childhood history indicated that no major problems were identified and she had no past surgeries. The patient obtained all of her developmental milestones appropriately and on time. Both of the patients parents and sister are healthy, and there are no known neurologic developmental disorders in the family. There are also no major social history problems. A physical examination indicated that the child was well nourished, well hydrated and had no acute distress. All other general physical exam findings were normal. Results of a neurological exam showed that the patient was alert and oriented to place and persons and that her mood appeared normal. No signs of excessive anxiety or agitation were noted, and her developmental receptive and expressive language skills appropriate for her age level. All cranial nerve and musculoskeletal tests performed were normal. The patient was assessed as having increasing paroxysms consistent with episodic dystonia or possible subtle seizures. The etiologic diagnosis reported that those events were of uncertain etiology and significance, characterized by intermittent muscular movements, most consistent with dystonia and most often involving the patient's legs but sometimes the arm and face. There was minimal change in consciousness and minor EEG changes. The neurologic diagnosis reported general normal growth development and neurologic function with no major neurologic processes or metabolic disturbances. It was noted that htere is an ongoing consideration of seizures and dystonia. The medical diagnosis indicated that no major medical problems were identified. Medical records received from a prolonged video recording with prolonged outpatient awake/asleep EEG performed on 11/19/01 indicated that the patient had a history of normal standard EEG in the past. It was noted that the prolonged EEG was requested to evaluate for epileptiform discharges. It was reported that the EEG performed over approximately 1.5 hours was abnormal because of periodic spike-like sharp transient occasionally isolated in the right central regions of the brain, but also occurring independently over other head regions. The clinical correlation indicated that the EEG was consistent with a mild diffuse disturbance of brain function and posibly consistent with a seizure disorder. Clinical correlation was advised. The physician who assessed the patient noted that there were a number of subtle abnormalites in the EEG. Many of the spikes were isolated or occurred following slow waves. Some spikes had positive and some had negative polarity. Occasionally sharp waves were seen over the frontal and posterior regions as well. No clinical changes were observed during the EEG. The physician noted that the events themselves; however, were more typical for dystonic posturing. Two events were observed on the EEG in which there was toe curling. In addition there were some plantar flexion posturing of the legs. During this, the patient almost appeared to flex her legs and cross her legs to break the pattern. The physiican felt that even more concerning; however, was the description by the patient's father about the jaw movements. He felt that this type of system could be more typical for benign rolandic epilepsy of childhood with central temporal spikes. He noted that in this condition, there are often times oropharyngeal or facial manifestations that include involuntary movements or tonic fracntions of the jaw. He reported that management options at this time would include a diagnostic trial of medications. Consideration of a two to three week course of low dose carbidopa 25/ levodopa 100mg tabs given as one quarter tablet bid for the first week, and one quarter tablid bid for the second week and doses up to one half tablet bid in the third week depending on the patient's response were proposed. Consideration of an anti-epileptic drug therapy trial was also proposed if the episodes perisited after the levodopa trial. Further observation of the patient for the time being was also planned. The patient's parents elected at this tiem to consider their options and to observe clinically for a greater period of time. The patient's parents felt that the patient's episodes were related to the therapy with MMR (second generation). Upon internal review, abormal EEg, episodic dystonia/intermittent muscular movements, seizure disorder and abnormal jaw movements were determined to be other important medical events. Additional information has been requested. Follow up indicated that as of 2/12/02 the reporter has not had further contact with the patient. There is no new diagnosis or additional information. No further information is available. Y U 07/17/2001 08/17/2001 31 EEG-nml 8/22/01 PVT PUB NONE NONE WAES01090077 1
0175400 09/17/2001 FL 0.3 0 .4 M 06/04/2001 This infant had a high fever of 103, vomiting, no appetite, pale, diarrhea, and keep dozing off. Diagnosis was severe reaction to Prevnar per family physician. Treatment at the hospital was IV Suprax. Y Y 3 U 02/19/2001 02/19/2001 0 UNK PUB PUB NONE NONE Torticollis FL01022 1
0175401 09/17/2001 FL 1.2 1 .2 F 08/24/2001 On 8/17/01 at 17:30, pt was immunized. At 18:30, pt developed a temperature of 101F. On 8/18/01 at 02:30, took to ER with temperature of 103.7F and a seizure and was admitted to hospital. Pt was started on IV anti-seizure medicines. On 8/20/01, pt was discharged from hospital. Y Y 3 Y 08/17/2001 08/17/2001 0 PUB PUB NONE NONE Mother states pt has a history of pneumonia and tubes in ears. FL01017 1
0175404 09/17/2001 FL 9.0 9 M 09/06/2001 On 03/16/2001, this child was vaccinated with a 2nd dose of pneumococcal vaccine 23 polyvalent. It was noted that on 06/02/00, the patient received a 1st dose of pneumococcal vaccine 23 polyvalent. On 06/16/01, three months after the 2nd vaccination, the patient was diagnosed with graves disease. Unspecified medical attention sought. Upon internal review, Graves Disease was considered an other important medical event. F/U info from the pt's endocrinologist indicated that he did not think there was an association between the Graves disease and the pneumococcal vaccine (manufacturer unknown). Additional info has been requested. F/U states that information has been received from a consumer concerning her 10 year old son with no known drug allergies, a history of ear infections and varicella (1996) and a family history of thyroid diseases (dad, thyroiditis) who on 6/2/00 was vaccinated in the left leg with a 1st dose of pneumococcal vaccine 23 polyvalent (lot 469402 invalid lot for this product). The mother reported the vaccine to be "pneumococcal" vaccine and the physician calls it "23 valent pneumococcal vaccine". Medical records received stated that the dose given on 6/2/00 was Streptococcus pneumonia vaccine (Prevnar) (lot 469402). Concomitant medication included a dose in the right arm of Hep-B (lot 633866/1958J). There was no illness at the time of vax. On 3/15/01, the child was seen for a well visit. The physician reported that he had been encouraging the family to have the child lose some weight. On this visit, the child had reported that he had taken up 4 different sports and had a 10lb weight loss. The physician reported, and medical records confirmed, that on 3/16/01, the pt received a dose in the left arm of Prevnar (lot 474724), a dose in the left arm of Hep-A (lot 637331/1358L) and a tetanus shot in the right arm (lot U0375AA). It was reported that sometime in 10/00, the parents started noticing weight loss on the child. The weight loss continued until 5/01 when the child was looking ill. He had blood tests done and in 5/01, the pt was dx'd with Graves disease. The child was seen by an endocrinologist on 5/15/01 for the new onset Graves disease. The endocrinologist reported that in the fall of 2000, the child starting eating and drinking a lot and had a lot of weight loss. He had gone from 98lbs to 85lbs and had an elevated heart rate. Other than being a little more active and having a tremor, he did not have any significant problems. He took only vitamins and had no other medical problems. His physical exam was normal except for fine tremor to his hands when they are stretched with his fingers spread and an "impressive" thyroid. It was reported that the pt's free T4 was at 5.7. TSM suppressed to 0.1 and his SMAC-23 was normal. The child was being started on propranolol (Inderal) (10mg Q8 hr) and methimazole (Tapazole) (10mg TID) and had labs scheduled for the following week. F/U info from the pt's endocrinologist indicated that he did not think there was an association between the Graves disease and the pneumococcal vaccine. F/U info from a physician indicated that the childs's mother requested that he receive the pneumococcal vaccine because he had a history of multiple ear infections. It was also reported that the mother requested the Hep-A vaccine for travel purposes. The physician indicated that the pt was doing fine and that the endocrinologist thought the child would go into a complete remission. The reporter felt the pt's experience was disabling. Y Y U 03/16/2001 06/16/2001 92 Diagnostic lab-dx'd with Graves disease; physical exam-nml except for impressive thyroid; body weight-98lbs on 10/00; TSH-0.1; HR elevated; Total serum thyroxine-5.7; SMAC-23 (nml); body weight-85lbs OTH OTH Vitamins (unspecified) Otic infection; varicella WAES01082663 1
0175405 09/17/2001 NC 1.0 1 .0 M 09/06/2001 On 8/22/01 the pt began to vomit and had a seizure. He was taken to the ER and admitted to the hospital. He underwent a number of test including a lumbar puncture with results pending. The reporter noted that the physicians are leaning towards a diagnosis of encephalitis. The pt's physician wanted to submit a CSF specimen for PCR analysis. It was unknown if the pt had a recent exposure to varicella or other viruses. Follow-up states the pt's symptoms are related to herpes virus and not to varicella. Therefore the remaining SCF was sent to be analyzed for herpes as well as enteroviruses. It is noted at this point the pt's symptoms do not appear to be related to the varicella vaccine. Additional information has been requested. F/U states: Information has been received from an RN and a physician concerning a 12 month old white male with no allergies and no significant medical history, including no recent illnesses, no immunosuppression and no recent travel. On 8/6/01, the pt was vaccinated with the 1st dose of varicella vaccine (lot 634492/0931K also reported as 638250/0467L) SC in the right thigh. Concomitant medication on an unspecified date included 1 dose of Haemophilus B conjugate vaccine. On 8/22/01, at 04:33, the pt began to vomit and had a fever and a prolonged seizure. He was taken to ER and admitted to the hospital for 7 days. It was noted that he was somnolent for days after the event. The pt was irritable and unsteady, gradually improving over 1 week. "By history, the pt was recently immunized and certainly A.D.E.M. is a possibly, although this is typically seen in the subcortical white matter". The RN noted that the physicians are "leaning towards a dx of encephalitis". The pt's physician wanted to submit a CSF specimen for PCR analysis; however, it was noted that a CSF specimen for PCR analysis will not be sent because only 0.5cc of the CSF was remaining and the treating physicians suspected the child's symptoms were related to herpes virus and not to varicella. Therefore, the remaining CSF was sent to be analyzed for herpes, as well as enteroviruses. The physician noted that there was insufficient CSF for VZV PCR or other viral studies. It was noted that "the doctors do not feel at this point, that the child's experiences are related to (varicella virus vaccine live, and that unknown if the pt had a recent exposure to varicella or other viruses. Subsequent follow-up information from a physician noted that the dx was acute disseminated encephalomyelitis. The physician noted that there was no evidence of a bacterial infection. No further information is available. Y Y Y 08/06/2001 08/22/2001 16 lab test - pending, spinal tap - pending, cerebrospinal fluid - pending; F/U states: WBC-8.5 X/mcL (L); RBC-3.75 M/Ul (L); MCV-79 (L); Neutrophils 71% (H); Lymphocytes 19% (L); General chemistry on 8/22/01-nml except glucose-179MG/DL (H) and on 8/25/01-nml except potassium 5.5MMOL/L (H); CO2-21.6MMOL/L (L); BUN-8MG/DL (L); Creatinine-0.3MG/DL (L); venous blood gas pH-7.33; PCO2-49.1MMHG; PO2-37MMHG; O2 sat-66%; base excess-0.3, bicarbonate-23.3MMOL/L; UA-nml; CSF-RBC-5/UL (H) (tube 3) and 28% (L), glucose 87MG/DL (H) and protein 21MG/DL; blood cx-neg; herpes simplex virus by PCR-neg and stool swab for viral cx-neg; MRI of brain without contrast-"there was no evidence of acute intracrainial hemorrhage and no developmental anomalies identified", there is a mild degree of heterogenous signal in the thalami, right greater than left (This is of uncertain etiology). "The flow signal within the major intracranial vessels is nml. The impression was noted as "th signal intensity in the thalami is somewhat heterogeneous, of uncertain etiology". PVT PUB NONE NONE NONE WAES01082585 1
0175410 09/17/2001 NV 0.5 0 .5 M 09/05/2001 This baby was observed to be limp. The parent were unable to wake the baby up. He had upward rolling of the eyeballs. No fever. Admitted to the hospital. Sepsis R/O, EEG, CT head - normal. Y 2 Y 08/27/2001 08/28/2001 1 CT of Head; CBC; BMP; EEG-all WNL OTH UNK NONE URI NONE 1
0175411 09/17/2001 MA 5.0 5 M 09/07/2001 Pt's skin on left upper arm with erythema, warmth, inflammation and vesicles. The area is 3/4 circumflexed around his arm. There is some mild (L) axillary adenopathy. The right arm with small area of 2.3cm in diameter of erythema, mild inflammation but no vesicles. FU recv'd from allergy consultation 11/27/01 states diagnosis of delayed type hypersensitivity reaction to vaccination. Y Y 09/05/2001 09/06/2001 1 Temperature-97.8F; Peripheral pulses (+); Patch test negative to thimerosal. PVT PUB Unspecified reaction~DTaP (no brand name)~5~4.00~In Patient 1
0175412 09/17/2001 FL 6.0 0 .1 M 07/23/2001 2 hours, post vax, child became quiet, slight temperature, became unresponsive and temperature went up to 104F. Mom took infant to ER and child was hospitalized for 2 weeks. Now child is mentally and developmentally delayed. Dx'd child as autistic and delayed developmentally. Y 14 Y N 06/22/1995 06/22/1995 0 UNK PUB PUB NONE NONE NONE FL01020 1
0175413 09/17/2001 MI 0.5 0 .5 F 08/28/2001 This infant's parent reported persistent crying lasting ten hours. The parent reported the infant would only be consoled when her mother was holding her. The parent reported fussy behavior, vomiting 2 or 3 times, fever (temp under 105 F). The parent called the doctors office. The parent treated the fever with acetaminophen. Y 07/06/2001 07/06/2001 0 NONE PUB PUB NONE NONE 1
0175414 09/17/2001 TX 1.0 F 08/30/2001 This patient had cellulitis and erythema bruise at the injection site on her right leg. Sent to ER for follow up. Y U PUB PUB PPD, left arm. NONE UNK 1
0175415 09/17/2001 NY 0.25 0 .2 F 09/07/2001 This infant screamed in pain for five hours after receiving her vaccine. She had to be held all day, and wouldn't nurse. We went to the ER and were told the reaction was likely from the Pneumococcal vaccine. Symptoms went away in time. Y Y 08/02/2001 08/02/2001 0 PVT OTH 1
0175416 09/17/2001 OH 1.0 0 1 M 09/07/2001 This infant had erythema 2" diameter with induration and puncture wound in the center anterior left thigh. Cellulitis left thigh, local reaction Prevnar injection. Augmentin 200 mg Bid x 5 -10 days. Y Y 08/31/2001 08/31/2001 0 NONE PVT PVT NONE NONE Recurring otitis media 1
0175417 09/17/2001 FL 1.25 1 .3 F 04/26/2001 This client received VZV vaccine on 03/29/01. The sister of the client received VZV vaccine at the doctors off on 11/11/98. The doctor confirmed both children developed varicella on 04/10/01. The mother indicated the children were not exposed to anyone with varicella. Y 03/29/2001 04/10/2001 12 PUB PUB NONE NONE FL01018 1
0175418 09/17/2001 PA 1.0 1 .0 F 09/07/2001 This infant had a fever of 103, maculopapular rash, diarrhea for 10 - 14 days. Supportive care. Y Y 08/21/2001 08/22/2001 1 PVT PVT NONE 1
0175419 09/17/2001 VA 1.0 1 .0 M 09/06/2001 This patient had a fever to 104 10 days after vaccination, 2 seizures (lasting 10 minutes each). Two ER visits, 2 doctor follow up visits. One week to recover. Y Y 08/15/2001 08/25/2001 10 CBC, Bloodwork. PVT OTH Antibiotic for ear infection prescribed 08/15/01. Ear infection. NONE 1
0175420 09/17/2001 NY 31.0 30 F 02/14/2003 Report A0352431A (formerly 2001021600-1) describes rheumatoid arthritis in a 31 year old female who received Lyme disease vaccine recombinant OspA (LYMErix). This report was received from the vaccinee, who is a pharmacist. The vaccinee had not history of gout, psoriasis, Crohn's disease, or Lyme disease. There was no family history of rheumatoid arthritis or lupus. On 08/18/99 and 09/23/99, the vaccinee received her first and second doses of Lymerix, respectively, without adverse event. In 09/00, she received her 3rd dose of Lymerix. In June 2001, she reportedly began to experience pain in all joints, especially the hips, knees, elbows, and hands. She also experienced stiffness in the knuckles of her fingers. On 07/10/01, she experienced pain in both knee and both elbow joints. The joints were not red or swollen. She was seen by a nurse practitioner in )8/01. No fluids was obtained from any joint. The vaccinee was treated with an unspecified anti-inflammatory medication. Unspecified "lab work" was performed. The vaccinee stated that she was "not sure", but the nurse practitioner called her on 09/07/01 and said she "may have positive lab work for Lyme disease". On 4/10/02, the vaccinee reported that she was seen by a rheumatologist, who made a diagnosis of rheumatoid arthritis of the hands. Reportedly, the symptoms were being treated with celecoxib (Celebrex) 200 mg twice daily and hydroxychloroquine phosphate (Plaquenil) 200 mg twice daily. As of 4/10/02, the rheumatoid arthritis was reportedly ongoing. As of 09/07/01, the outcome of the joint pain was unknown. The adverse event "joint pain" does not meet ICH serious criteria, but is being submitted as an expeditied report by special FDA request per the June 28,2000 letter. Y N 10/01/2000 06/01/2001 243 PVT PVT UNK A0352431A 1
0175421 09/17/2001 NJ 47.0 67 M 09/12/2001 The vaccinee received his 1st injection of Lymerix on 07/27/00. On 07/30/00, three days post-immunization, he experienced soreness and stiffness of his back, buttocks, and hip joints. He also experienced muscle weakness and was listless. No diagnostic evaluation was performed. The events resolved after approximately two weeks without treatment. The reporter considered these events to be mild in intensity and possibly related to Lymerix administration. The vaccinee received his 2nd injection of Lymerix on 09/07/00. On 09/09/00, two days post-immunization, he again experienced soreness and stiffness of his back, buttocks, and hip joints. He also experienced muscle weakness and was listless. He did not seek medical attention. The events resolved after approximately two months, without treatment. The reporter considered the events to be severe in intensity and possibly related to Lymerix administration. The vaccinee received his 3rd injection of Lymerix on 07/26/01. On 07/28/01, two days post-immunization, the vaccinee again experienced soreness and stiffness of his back, buttocks, and hip joints. He also experienced muscle weakness and was listless. No diagnostic evaluations were performed. The events resolved after approximately one week, without treatment. The reporter considered the events to be mild in intensity and possibly related to Lymerix administration. Y 07/26/2001 07/28/2001 2 PVT PVT Hytrin (Terazosin), Hydrochlorothiazide, Vitamins, Coumadin, Atenolol. 20010203811 1
0175422 09/17/2001 FL 66.0 59 F Symptoms began approximately 7 - 14 days after taking the injections. First symptoms were tingling in her feet and legs which quickly traveling to my hands, arms and most of my body. This followed with a weakness in my left knee which gave me a feeling that it would collapse, my right ear feeling "clogged with water", every little bump or touch went right through me. Left for Florida on 11/23, and was seen by a vascular doctor who ordered an MRI of the lower spine and an arterial doppler which were negative. Went to a neurologist and initially had a lyme titer, Western Blot was positive while the ELISA was negative. Ana was positive on one occasion and then negative. Electrodiagnostic studies were performed showing slow nerve conduction velocities with absent reflexes. CBC, sed rate, thyroid profile, random glucose, B12, folate acid, VDRL, Lyme's screen, conduction velocities (electromyograms) were all performed. Started on Doxycycline. Referred to Infectious Disease doctor and had a lumbar puncture on 01/26/95 followed by motor problems and pain which lasted some 3-4 weeks. Returned to NJ and was re-examined by my neurologist there who determined polyradiculoneuropathy. He started Elavil which I could not tolerate. I have all the records from all the doctors with test, dates, and results. I still suffer with constant pins and needles which lately has become more noticeable and annoying, with stronger throbbing radiating from the feet to the legs. Most of the other symptoms have all disappeared. N 11/07/1994 11/18/1994 11 MRI of the lower spine and an arterial doppler which were negative. Went to a neurologist and initially had a lyme titer, Western Blot was positive while the ELISA was negative. Ana was positive on one occasion and then negative. Electrodiagnostic studies were performed showing slow nerve conduction velocities with absent reflexes. CBC, sed rate, thyroid profile, random glucose, B12, folate acid, VDRL, Lyme's screen, conduction velocities (electromyograms) were all performed. Lumbar puncture on 01/26/95. PVT OTH Inderal LA 1
0175423 09/17/2001 MO 1.5 1 .5 M 09/01/2001 Pt developed a low-grade fever, post vax. Pt began a downhill condition after 18 month DPT. He lost all previous cognitive, language and pragmatic skills by 27 months of age. Now has been dx'd with severe autistic disorder. Y N 08/21/2000 08/21/2000 0 EEG-abn; CAPS; Speech and OT evaluations PVT OTH NONE NONE NONE 1
0175424 09/17/2001 MO 0.5 0 .5 M 09/01/2001 Pt developed a low-grade fever, post vax, and began losing skills after 18 month DTAP. He lost all skills of language, cognitive and pragmatic. He formed major sensory issues by the age of 27 months. Now has severe autistic disorder. Y N 09/01/1999 08/21/2000 355 EEG-abn; CAPS; Speech and OT evaluations PVT OTH NONE NONE NKA 1
0175425 09/17/2001 MO 0.3 0 .3 M 09/01/2001 Pt developed a low-grade fever, post vax, and began losing skills after 18 month DTAP and then lost all skills of language, cognitive and pragmatic. He formed major sensory issues by the age of 27 months. He now has severe autistic disorder. The annual follow-up states "severe autistic disorder, intestinal dysbiosis, severe malabsorption, leaking gut syndrome, heavy metal toxicity, chronic yeast infection, severe food allergies." Y N 06/22/1999 08/21/2000 426 EEG-abn; CAPS; Speech and OT evaluations PVT OTH NONE Right otitis media NONE 1
0175426 09/17/2001 MO 0.2 0 .2 M 09/01/2001 Pt developed a low-grade temperature, post vax and began a downhill condition after his 18 month DTAP. He lost all previous cognitive, language and pragmatic skills by the age of 27 months. Now he is dx'd with severe autistic disorder. Y N 04/19/1999 08/21/2000 490 EEG-abn; CAPS; Speech and OT evaluations PVT OTH NONE NONE NONE 1
0175427 09/17/2001 FL 5.0 5 F 05/22/2001 This child received VZV on 05/04/2001, sibling broke out with varicella disease on 05/18/01. Mom states she had not been around anyone with the chicken pox. Y 05/04/2001 05/18/2001 14 PUB UNK NONE NONE FL01019 1
0175428 09/17/2001 FL 43.0 43 M This patient received MMR on 08/01/01 on 08/11/01 he broke out with severe rash and had a high fever of 102. On 08/13, he went to his MD, got a prescription for Atarax, still covered with rash and temp of 100.Is presently on quarantine. Y 08/01/2001 08/11/2001 10 PUB PVT NONE NONE NONE FL01016 1
0175429 09/17/2001 MI 1.25 1 .3 M 08/31/2001 Local reaction (erythema and induration 1 1/2" in diameter causing pain and difficulty walking) on left thigh. Treated with acetaminophen initially followed by Ibuprophen after calling LHD. U 08/29/2001 08/29/2001 0 PUB PUB Also had IPV, Connaught, lot # T07852, SC, left arm on 08/29/2001. 1
0175430 09/17/2001 IL 1.0 1 .0 F 09/05/2001 By 08/30/01, the patient became very cranky and irritable, temp > 103 - 104, lasted for 48 hours. Y Y 08/22/2001 08/30/2001 8 PVT UNK NONE NONE 1
0175431 09/17/2001 IA 44.0 44 F Granuloma formation left forearm after incorrect administration of DT instead of PPD. Y 07/17/2001 07/18/2001 1 PVT PVT 1
0175432 09/17/2001 GA 35.0 35 M 08/31/2001 At 1:00 PM, telephone call from client, complaining of feeling like his forehead was on fire and was breaking out with hives. States he is on his way to the Health Dept. At 2:00 PM, the client never arrived to the clinic. On 09/04/01, unable to contact the client at home. U 08/31/2001 08/31/2001 0 PUB PUB NONE NONE NONE GA01084 1
0175433 09/17/2001 MI 0.75 0 .8 M 08/31/2001 This infant had a rash on his body with out fever. U 08/29/2001 08/30/2001 1 PVT PVT NONE Hypotonia Hypotonia 1
0175434 09/17/2001 GA 22.0 22 F 06/29/2001 This patient has soreness of the left arm and left scapular region 20 minutes after vaccine to present. Redness at the injection site, left deltoid. The patient states she felt sluggish, over tired 1 hour after the shot and she been feeling the same since. U 06/27/2001 06/27/2001 0 PUB PUB Ortho Tryclon, Advil. Allergy to Penicillin, Vicodin, Darvocet. GA01074 1
0175435 09/17/2001 NJ 1.5 1 .7 M 08/22/2001 V/S stable. Minimal erythema around left eye bite mark. Allergy vs hives secondary to insect bites. U 08/22/2001 08/22/2001 0 PUB PUB NONE NONE NONE NJ200116 1
0175436 09/17/2001 IL 86.0 87 F 09/07/2001 This patient's arm became red, swollen, and itchy from the deltoid to the elbow. U 09/05/2001 09/07/2001 2 NONE OTH PUB NONE Alzheimer's disease. 1
0175437 09/17/2001 MI 1.0 0 .1 M 09/10/2001 Varivax was given SC on outer aspect of left leg. Hib was given IM in the same leg. Mom states that he got a lump which went away by 2 weeks after shots, then rash returned and remains. The rash is pinkish, raised in small clusters and scattered. It is not inflammed and doesn't itch, but he holds leg and cries occasionally. It is relieved when baby lotion rubbed on. Still has rash today. Child is going to be seen tomorrow for possible hip/leg problems. He is not walking or weight bearing. Y N 08/16/2001 08/30/2001 14 NONE PUB PUB NONE NONE Esophageal Reflux 1
0175438 09/17/2001 MI 26.0 26 F 08/28/2001 Pt experienced malaise 9 days, post vax. She experienced severe headache and severe fatigue and myalgia 10 days, post vax. About 12 days, post vax, she had a rash on her face, chest and arms and ended about 15 days, post vax. She treated the pain with Aleve. Pt missed work and school. Y 03/14/2001 03/23/2001 9 NONE PUB PVT NONE NONE Respiratory allergies; asthma 1
0175439 09/17/2001 NC 49.0 49 M 08/30/2001 Pt had flu-like symptoms with aching and fever from 8/27/01, late afternoon. He had a rash on Friday morning on 8/31/01 and turned into blisters with a splitting headache. On 9/4/01 was feeling some better. Rash had gone away and headache had improved. By 9/10/01, was back to normal. Dx: Lyme disease. Y Y 08/27/2001 08/27/2001 0 Liver profile-Rocky Mountain Spotted Fever PUB PVT Atacand-BP; Paxil 20mg NONE Increased BP 1
0175440 09/17/2001 OH 0.5 0 .5 F 09/10/2001 Received call from mother, saying child had raised area on left VL approx. 2cm-4cm, warm to the touch with redness. No increased temperature. (+) TTP. Y Y 08/28/2001 08/29/2001 1 PVT OTH Cough and congestion for 2 days NONE 1
0175441 09/17/2001 FL 19.0 19 F 06/15/2001 Pt developed a severe headache and a fever of 103F about 3 minutes, post vax. 12 hours later, pt had joint aches, a sore throat with difficulty swallowing and complained of shortness of breath 12 to 24 hours later. Fever of 100F-102F for the past 2 days with a pounding headache. Y 06/12/2001 06/13/2001 1 UA on 6/13/01-WNL; with a few WBC's PUB UNK Ibuprofen; Tylenol; Allegra NONE PCN allergy FL01021 1
0175444 09/18/2001 NJ 50.0 49 F 12/26/2000 Pt developed chronic muscle disease of arms, legs, hands and feet. Pt also had Lymerix vaccines on: 4/12/99-LY104A2 and 5/13/99-LY116A2. Per doc 205270: same, still pain in arms and legs; still on prednazone. The annual follow-up states "still muscle pain and extreme fatigue. Still on prednazone." Y N 11/01/1999 03/01/2000 121 EMG X 2; Muscle Biopsy 6/00 PVT PVT Prednazone 1
0175445 09/18/2001 PA 60.0 60 M 09/10/2001 Severe joint pain dx'd as palindromic rheumatoid arthritis. Aggressive medical treatment with Azulfidine and prednisone. Requires follow-up blood tests to check for liver and kidney damage. Also had 2nd Lymerix on unspecified date. Per doc 205104, 60 Day follow up, patient has been diagnosed with palindromic Rheumatism which is the result of taking lymerix. The annual follow-up states that "this patient has not recovered from effects of LYMErix vaccination. His condition has seriously deteriorated in the past year. Three physicians, one his primary care physician and two rheumatologists, have diagnosed his condition as palindromic rheumatism that is causing increasing pain, swelling and disability. He can walk only short distances, is unable to do most physical work and cannot enjoy and physical recreation. He is also suffering the effects of prolonged use of Prednisone taken for severe joint inflammation. The medications he takes, and has previously reported for treatment of rheumatoid arthritis, require monthly blood tests to determine if any liver of kidney damage have occurred." Y Y N 06/30/1999 10/01/1999 93 Tested for Lyme disease and rheumatoid arthritis PVT PVT NONE Unspecified reaction~Lyme (LYMErix)~2~60.00~In Patient 1
0175446 09/18/2001 IA 1.25 0 .7 M 09/12/2001 Following 1st and 2nd dose of Prevnar, client developed extreme fussiness, personality change and awoke 2-3 times every night. Symptoms started within 24 hours, post vax, and lasted approx. 2 weeks. Y 03/02/2001 03/02/2001 0 PUB PUB NONE NONE NONE IA01012 1
0175447 09/18/2001 IL 0.2 0 .2 F 09/10/2001 The pt was given vaccines on 9/8/01. Approx. 4-6 hours, post vax, the infant had an episode of atonia and eye deviation, lasting about 1 minute, after which she was lethargic for about 15 minutes. The mother checked temperature at that time and pt was not febrile. Exam, shortly after in the hospital ER was normal. Y Y 09/08/2001 09/08/2001 0 NONE PVT PUB NONE NONE Family history of febrile seizures. 1
0175448 09/18/2001 IN 0.3 0 .4 F 09/06/2001 Per mom, post vax, at approx. 11:00, the pt took 1 oz of formula and fell asleep. She was awakened at approx. 16:00 and she refused to eat. She started crying non-stop at 17:30 to 19:30, and then fell asleep at 19:45. At some time this evening, her temperature climbed to 103.2F and she was taken to ER. In ER she was vomiting and was given suppositories at ER. On 8/30/01, she was taken to a pediatric doctor and blood and urine samples were taken. She was given a shot of Rocephin at this time. Both legs were red and swollen at injection sties. On 8/31/01, she was taken back to the doctor because of continued diarrhea and vomiting. Another shot was given; mom is not sure what it was but she thinks it was Rocephin. On 9/1/01, mom states she took some Pedialyte but pushed nipple back on formula. She had less diarrhea and vomiting today. On 9/2/01, the baby took 12 oz of formula today. No Pedialyte offered. but less diarrhea and vomiting than yesterday per mom. On 9/3/01, mom felt she was "turning around" for the better by today. The way the baby acted, ate and slept, she was better. On 9/5/01, she was seen again by the doctor for a check-up. Baby was back to "normal" per the doctor and the mom. Y Y 08/29/2001 08/29/2001 0 WBC-23.8 (high);Differential-% neutrophils-55% (high); % lumphocytes-26% (low) PUB PUB Digoxin; Lasix; Reglan; generic Aldactone; Zantac; Infant Tylenol NONE Down's; Atrial and Ventricular Septal Defect; Congenital Heart 1
0175449 09/18/2001 TX 1.75 1 .8 F 08/30/2001 Pt had no reaction within 20 minutes, post vax. On 8/23/01, awakened with swelling, redness in left leg and a temperature of 101F-102F (ax). On 8/27/01, pt had a rash over entire body but no fever. Mother called doctor's office and was told to give Benadryl. On 8/28/01, the rash continued over entire body, no fever, but took child to see the doctor and was given Dexamethasone to be taken by mouth. On 8/29/01, the pt continued to have a rash but no fever, so took child to see another pediatrician in El Paso but no medicines given. Y 08/22/2001 08/23/2001 1 PUB PUB NONE NONE NONE TX01129 1
0175450 09/18/2001 ID 1.6 1 .6 M 08/22/2001 Pt had a temperature of 104F for 48 hours and diarrhea which lasted until the next morning. Mom used Tylenol alternating with Motrin, tepid baths and increased fluids. She finally took him outside in the cold. She states she could not get his temperature to break. Y 01/22/2001 01/22/2001 0 NONE PUB PUB NONE Premature at 33 weeks with no complications ID01044 1
0175451 09/18/2001 TN 0.3 0 .4 F 09/04/2001 On 8/31/01, pt's fever was 102.8F and was pulling at left ear and throwing up. Pt was taken to PCP. Pt had ear and throat infection. Still sick on 9/4/01. Y N 08/30/2001 08/31/2001 1 CXR-neg; WBC-increased PUB PUB NONE NONE NONE TN01044 1
0175452 09/18/2001 TN 5.0 5 M 09/07/2001 Gave vaccines and apparently child ran fever, then possibly had a febrile seizure. Y U 09/07/2001 09/07/2001 0 PVT PUB NONE NONE NONE TN01045 1
0175453 09/18/2001 IN 0.3 0 .3 F 09/06/2001 Per mom; noticed redness, swelling and 99F temperature on 8/30/01 at 08:00. Tylenol was given at that time. On 8/31/01, redness/swelling was gone but there was a "knot" palpable. No loss of appetite; breast feeding. One "looser" than normal stool noted by mom during the episode. Y 08/29/2001 08/30/2001 1 NONE PUB PUB NONE Occasional cough NONE 1
0175454 09/18/2001 RI 2.0 2 .1 M 09/10/2001 Administered Prevnar and HIB on 9/7/01. Pt was restless with a low-grade temperature that evening and a high-grade temperature in the morning at 11:30 on 9/8/01. Pt had difficulty breathing and went to ER. Was treated with IM steroid and mist treatment. Y Y 09/07/2001 09/08/2001 1 NONE MIL MIL NONE History of croup; prematurity with O2 given for 2 weeks. 1
0175455 09/18/2001 KS 0.5 0 .3 F 09/12/2001 Pt developed inconsolable crying within 12 hours of 4 month immunizations. She also had a fever of 103F for 48 hours. Y 07/03/2001 07/03/2001 0 NONE PVT PVT Tylenol NONE NONE 1
0175456 09/18/2001 IL 1.3 1 .0 M 09/10/2001 Pt developed a generalized macular-papular blanching 1mm rash on trunk, extremities and face. U 09/07/2001 09/09/2001 2 NONE PUB OTH NONE NONE NONE 1
0175457 09/18/2001 MS 0.75 0 .8 M 09/07/2001 Pt complained of rash around injection site "looked infected", according to the doctor. States other areas of rash on body were "big, red splotchy areas". Seen by PMD on 8/24/01 and treated as infection and reaction. On 8/27/01, rash subsided except for some on extremities at injection site only. Y Y 08/23/2001 08/24/2001 1 UNK PUB UNK Benadryl; Robitussin Resolving URI NONE MS01040 1
0175458 09/18/2001 1.5 1 .5 M 08/27/2001 Pt had a large 8cm diameter local reaction to immunization with reported systemic fever and large red, raised annular reaction at injection site. Y Y 08/22/2001 08/23/2001 1 NONE MIL MIL NONE NONE NONE 1
0175459 09/18/2001 PA 1.0 1 .0 M 09/12/2001 On 9/11/01, child awoke with giant hives over entire body but no mucous membrane involvement. Y 09/10/2001 09/11/2001 1 NONE PVT PVT NONE NONE NONE 1
0175460 09/18/2001 AR 1.0 1 .0 F 08/29/2001 Pt developed a temperature on Monday evening and shaking for approx. 1 hour. On Tuesday, temperature was normal during the daytime but increased and had shaking during the PM. U 08/27/2001 08/27/2001 0 PUB PUB NONE NONE NONE AR3801 1
0175461 09/18/2001 AR 0.2 0 .2 F 08/23/2001 Grandmother stated that infant cried inconsolably for 5 hours. (Pt had IPV/Connaught/T0786/IM/LL/0 previously on 7/16/01). Y 07/09/2001 07/09/2001 0 PUB PUB NONE Apnea Apnea AR3701 1
0175462 09/18/2001 FL 4.0 4 M 09/13/2001 Post vax, pt had 2.5cm-3cm area of erythema at injection site on left deltoid. U 09/11/2001 09/11/2001 0 NONE PVT PUB NONE NONE NONE 1
0175463 09/18/2001 GA 1.5 1 .5 F 09/10/2001 Pt developed a large area at right anterior thigh local reaction with erythema, tenderness, warmth and induration 3 1/2" X 2 1/2" which improved by 72 hours, after onset. Also had low-grade temperature for 48 hours that is now resolved. Still with erythema. N 09/07/2001 09/07/2001 0 NONE PVT PVT NONE NONE NONE 1
0175464 09/18/2001 NJ 4.0 1 .5 M 09/12/2001 Pt developed a moderate to severe case of chickenpox. Expected recovery. U 08/25/1997 09/12/2001 1479 PVT PVT PPD 1
0175465 09/18/2001 OH 1.0 1 .0 F 09/04/2001 Pt started running a low-grade fever 24 hours, post vax. Temperature was around 100F-101F and ran a fever for approx. 12 days. She was seen by a physician and nothing was found and was sent home. She did have a febrile seizure X 1. Seen in ER. Pt was given Rocephin in the event of meningitis. Recovered with no residue problems. Y Y 05/10/2001 05/11/2001 1 CXR; Catheterized urine; Blood culture done and were all neg. PUB PUB NONE NONE OH0050 1
0175466 09/18/2001 NE 5.0 5 F 09/11/2001 Pt was given varivax shot in right arm. Pt developed a headache and the injection site was red and swollen at the injection site. Also had mild stiffness of her neck. Y 09/08/2001 09/09/2001 1 PVT PVT NONE 1
0175467 09/18/2001 MA 11.0 10 F 09/17/2001 Swelling / Pain of forearm and dorsum of the hand (occurred on the side of the shot was administered). Time course 12-15 hours of the shot. Prescription ace bandage, ice, elevation rest. Complete resolution in 72 hours. Y 09/11/2001 09/11/2001 0 NONE PVT UNK NONE NONE NONE 1
0175468 09/18/2001 TX 33.0 33 F 09/15/2001 Right arm, neck warmness after injection of typhoid vaccine to her right upper arm. Subsided 13:30. Y 09/15/2001 09/15/2001 0 NONE MIL MIL Allegra,Flonase, Entex Allergies Allergies 1
0175469 09/18/2001 VA 1.0 1 .1 F 09/12/2001 48 hours after vaccination, the mother states a rash to the face, neck then spread to the rest of the body became "welt like", and both eyes were swollen. No difficulty breathing, vomited 1 time. Went to the ER. Temperature of 100. Y Y 09/11/2001 09/11/2001 0 PVT PUB 1
0175470 09/18/2001 PA 4.0 4 F 09/11/2001 The mother states small red bumps developed on child's torso and chin, mild itching. No fever present. 09/11 rash fading. Y 08/29/2001 09/10/2001 12 PUB PUB NONE NONE 1
0175471 09/18/2001 IN 1.25 1 .3 F 09/06/2001 Per mom - symptoms started on 08/30/01 at 8 am, redness size 3 inches in diameter (left leg) with complaints of pain. Tylenol given Thursday and Friday 2 times both days. Mom says "spot" is pin point size since 09/01/01, no "knot". Y 08/29/2001 08/30/2001 1 NONE PUB PUB NONE Diarrhea, no fever. NONE 1
0175472 09/18/2001 IN 1.4 1 .5 M 09/06/2001 Per mother's friend, symptoms started Wed., 08/29/01, in the evening, complained of redness, swelling, and soreness in the left leg. Tylenol was given for treatment of symptoms. Friend brought baby for shots with permission by mom. Y 08/29/2001 08/29/2001 0 NONE PUB PUB NONE NONE NONE 1
0175473 09/18/2001 IN 1.25 1 .3 F 09/06/2001 Symptoms started approximately 4 hors after injections. Didn't want to eat supper. Screamed when she stood up. Cried "alot" between 5:30 pm and bed time at 8:30 pm. Mom says redness size of nickel, no "knot". On Thursday, 08/30/01, symptoms continued per mom so appt was made at the doctors for 3 pm and taken to the appt. The doctor ordered amoxicillin. The parent gave the child Tylenol thru Thursday and it was not needed on Friday. Y Y 08/29/2001 08/29/2001 0 NONE PUB PUB NONE Indigestion night before. NONE 1
0175474 09/18/2001 IN 1.6 1 .6 F 09/06/2001 On 8/29/01, on awakening at 07:00, the child would not stand on left leg and cried with pain upon trying to stand. Her left leg is swollen, 2" in diameter, warm to touch, with a "knot", but no redness noted. Mom used Advil for low-grade temperature and pain. She used a cool wash rag to area and mom massaged leg. On 8/30/01, the pt is back walking without complaint of pain, swelling is gone, "knot remains palpable per mom in left leg. Y 08/28/2001 08/29/2001 1 NONE PUB PUB NONE NONE NONE ~DTaP (no brand name)~3~0.50~In Sibling 1
0175475 09/18/2001 MO 6.0 6 M 09/05/2001 On 8/17/01, mother reported red, hot and puffy area, the size of a half dollar, on the right deltoid area. No complaint of discomfort. Y 08/14/2001 08/17/2001 3 PUB PUB MO2001048 1
0175476 09/18/2001 MO 4.0 4 F 08/31/2001 Pt had a 3" radius of redness, puffy and hot on RVL where DTAP was given. Y 08/29/2001 08/31/2001 2 PUB PUB MO2001048 1
0175477 09/18/2001 MO 1.25 1 .2 M 08/31/2001 Per MD, "rash is probably due to MMR immunizations", under eyes, toes, legs and belly. Temperature 101F on 8/20/01. Ankle swelling and pain with a limp Y Y 08/17/2001 08/20/2001 3 X-ray-ok PUB PUB NONE NONE NONE MO2001046 1
0175478 09/18/2001 MO 16.0 16 F 08/20/2001 On 8/17/01, pt developed dizziness in the evening and a sore throat on 8/18/01. Also, developed a fine, red rash on neck and anterior cheek, blanched with pressure. Her neck itches. Sent to MD for evaluation for possible strep. MD states that it is not strep. Y Y 08/16/2001 08/17/2001 1 Strept test done to rule out strep throat-neg PUB PUB Levothroid 25 mg NONE Low thyroid; Reynaud's Disease; ? antibiotic causes nausea and vomiting MO2001045 1
0175479 09/18/2001 TX 1.5 1 .5 M 08/30/2001 Pt developed hives all of his body. Injection site was swollen and pink. The symptoms are resolving. Y U 08/28/2001 08/28/2001 0 PVT PVT NONE NONE NONE 1
0175480 09/18/2001 TX 11.0 11 F 08/20/1991 Pt developed a rash on her left arm where the varicella vaccine was received. No fever, sweats, chills, vomiting or diarrhea. U 08/17/2001 08/28/2001 11 PUB PUB TB (PPD)/Connaught/C00868AB/ID/RA NONE NONE TX01128 1
0175481 09/18/2001 TX 5.2 5 F 08/15/2001 At 14:45, after 20 minutes, pt's right leg was with swelling and a 4.5cm reddened area. Cool compresses were applied to the right leg. At 15:05, the reddened area was 2.5cm. Pt was observed for 1 hour, post vax, with no other symptoms of allergic reaction noted. On 8/9/01, mother reported all redness and swelling was gone. Y 08/08/2001 08/08/2001 0 NONE PUB PUB NONE NONE NONE TX01127 1
0175482 09/18/2001 TX 4.0 4 F 08/29/2001 The pt experienced redness, hot and swollen left thigh. U 08/27/2001 08/28/2001 1 CBC / WBC - 12.0 elevated, Lymph - 4.6 PVT PUB heat rash on back TX01126 1
0175483 09/18/2001 WA 5.0 5 M 08/09/2001 Child fainted and had seizure activity, post vax. The episode lasted about 45 seconds and the child left on his own power. Y 08/08/2001 08/08/2001 0 PUB PUB ID01039 1
0175484 09/18/2001 ID 3.0 3 F 08/10/2001 Arthus-like rash and swelling on right deltoid. U 08/09/2001 08/10/2001 1 PUB PUB NONE NONE NONE ID01040 1
0175485 09/18/2001 ID 5.0 5 F 08/10/2001 Child received shots on 8/8/01. Denied adverse reactions or complications after previous shots. Noted left deltoid area to be red in color, warm and firm to touch, 2 days, post vax. Brought child to health dept immediately after observing this reaction. Explained to staff, that child also received 4 wasp stings the same evening of shots, but not in upper left arm. She did give Benadryl for wasp stings. Instructed her to repeat Benadryl and apply ice. Report to physician if becomes worse. Y 08/08/2001 08/10/2001 2 NONE PUB UNK NONE NONE ID01041 1
0175486 09/18/2001 ID 31.0 32 F 08/15/2001 Client received Hep-A and Hep-B on 2/21/01. She became itchy, had swollen hands and extremities. She was nauseated and her headache became severe. Hives appeared on arms and trunk. At 21:00, she went to ER and was medicated and released. She was told not to complete the Hep-A and Hep-B in the future. Y Y 02/21/2001 02/21/2001 0 PUB UNK Human R insulin and NPH insulin Allergy to codeine and Vicodin; Diabetes ID01043 1
0175487 09/18/2001 ID 5.0 5 F 08/29/2001 The pt's left deltoid area was red, very swollen and warm to touch. Looks similar to a tetanus reaction. Y 08/27/2001 08/28/2001 1 PUB PUB NONE NONE ID01045 1
0175488 09/18/2001 NJ 1.5 1 .5 F 09/09/2001 Mild listlessness occurred approx. 7 hours, post vax. Pt had a fever of 102.1F, 24 hours after injection accompanied by continuous crying, sweating and apparent discomfort. Symptoms disappeared 36 hours, post vax. Pt had no prior history of fever or similar symptoms. Pt examined on 9/6/01 at 14:30 and was dx'd with fever. No other symptoms. Y Y 09/05/2001 09/06/2001 1 PVT OTH NONE NONE NONE 1
0175489 09/18/2001 PA 4.0 4 F 09/15/2001 Mom states pt developed small, red bumps on torso and chin with mild itching. No fever was present. Mom took child to the doctor and was dx'd as a vaccine reaction. On 9/11/01, rash is fading. Y 08/29/2001 09/10/2001 12 PUB PUB NONE NONE 1
0175490 09/18/2001 OH 4.0 4 M 09/20/2001 Pt developed blistering, mild and painful rash on right arm at site of injection. Y Y 08/31/2001 08/31/2001 0 NONE PVT PUB NONE NONE NONE 1
0175491 09/19/2001 NY 39.0 39 F 11/06/2001 Information has been received from an NP concerning a 39 year old female who on 7/7/00, was vaccinated with 1 dose of varicella virus vaccine live (site unknown). On 8/4/00, during a routine check-up, the pt's urine was HCG positive. LMP: 7/4/00. The pt used the rhythm birth control method. The pt had not yet seen her gynecologist. Follow-up information from the nurse practitioner noted that the pt had a miscarriage and was currently well and was trying to conceive again. No further information is available. F/U states: The date of 2000 was added to field 11 to reflect the adverse event onset date of the miscarriage. N 07/07/2000 Urine beta-human on 8/4/00-HCG (+) OTH OTH NONE Pregnancy (LMP-7/4/00) WAES00080529 1
0175498 09/19/2001 KS 66.0 66 M 09/11/2001 At 07:38, BP-60/40 with profuse diaphoresis. Had syncope X 2 and left arm was swollen and red. Pulse 80 and weak (had collapsed 2 time during the night). At 07:40, BP-76/39, lethargic, pale and diaphoretic. IV fluids and O2 on transport to the hospital. BP was 112/70. Pt was given IV Rocephin in the hospital. He had arm cellulitis and axilla was hard. On 6/15/01, BP was normal. Warm compresses applied to left arm. Continues to be tired. Y Y 2 Y 06/13/2001 06/14/2001 1 WBC-increased PVT PVT NONE NONE NONE 1
0175499 09/19/2001 SC 0.2 0 .0 F 09/07/2001 Within 24 hours, post vax, pt's personality drastically changed. She cried uncontrollably, could not sleep and within 48 hours, post vax, she developed a fever of 100.9F. Because she was only 1 week old when the vaccine was given and with the high fever, she was admitted to the hospital. She then had to endure a spinal tap, IV antibiotics for 3 days and having blood drawn. No one listened to us as parents when we repeatedly said it was a reaction to the vaccination. They insisted on doing all of the tests, admitted her to the hospital and said she had contracted a virus of some kind. (No one knows what virus, etc.). Y Y Y 3 Y 07/03/2001 07/04/2001 1 All tests administered at the hospital were inconclusive except for her WBC was elevated. PVT OTH NONE 1
0175500 09/19/2001 MI 0.5 0 .5 M 09/11/2001 Pt developed a fever about 30 hours, post vax, with bulging fontanel. Y 2 Y 09/05/2001 09/06/2001 1 LP-No WBC's; Neg blood and spinal fluid cultures PVT PUB NONE NONE NONE 1
0175501 09/19/2001 CT 18.0 18 F 09/11/2001 Father called to report that his daughter had a grand mal seizure on 9/6/01 and he brought her to ER. She was discharged late PM. Follow-up being done with another doctor; a neurologist. Y Y Y 09/04/2001 09/06/2001 2 PUB PVT 1
0175502 09/19/2001 IA 19.0 19 F 09/06/2001 4 hours, post vax, the pt began developing hives on arms. Benadryl was given. Upon waking on the following day, 8/8/01, she was covered with hives, eyes were swollen shut and she had difficulty breathing and swallowing. Rushed to ER and medicines were given and then medications increased after 3 days. Hives lasted 7 days. Y Y Y 08/07/2001 08/07/2001 0 PVT PVT NONE NONE 1
0175503 09/19/2001 GA 0.3 0 .4 M 09/11/2001 The pt developed a fever of 101 the following morning. The pt experienced erythema of the thigh, with swelling or induration. Residual transient red spots ensued. Infant not taking milk as much or as usual. U 09/10/2001 09/11/2001 1 NONE OTH PUB NONE NONE 1
0175504 09/19/2001 CA 0.2 0 .2 M 08/29/2001 The pt experienced frequent persistent crying right after vaccinations. Prior to vax, he had been fussy with questionable diarrhea for 1-2 days. No redness or swelling at the site of shots. Y U 08/27/2001 08/27/2001 0 PVT OTH viral gastroenteritis NONE 1
0175505 09/19/2001 MI 0.3 0 .4 F 09/05/2001 On 9/4/01 the pt received vax and that afternoon was very fussy and crying allot. When the infant was not crying, she was sleeping. The mother was informed that it may be a side effect of vax. Instruct to administer Tylenol and to see primary MD if symptoms increase or last longer. The pt experienced a rash which was very red, blotchy but not raised. Went to ER for evaluation. the pt had a fever of 101 which increased to 104. Y U 09/04/2001 09/04/2001 0 PUB UNK NONE NONE NONE 1
0175506 09/19/2001 MA 1.0 1 .0 M 09/13/2001 The pt experienced a fever of 103 rectally, was fussy and clingy. U 09/04/2001 09/13/2001 9 U/A - nml, exam - nml PVT PUB NONE NONE NONE 1
0175507 09/19/2001 MN 0.36 0 .4 F 09/07/2001 The pt received the vax and the following day experienced a knot the size of a dime, hardness, some redness and is not getting better. U 09/04/2001 09/05/2001 1 PVT PVT 1
0175508 09/19/2001 TX 1.25 1 .3 M 09/14/2001 Erythema and swelling of 6" that was mildly tender with increased irritability. Y Y 09/13/2001 09/13/2001 0 PVT PVT Rynatan Susp; Novahistine URI symptoms but afebrile NONE 1
0175509 09/19/2001 PA 0.6 0 .6 F 09/13/2001 Pt developed a rash over her entire body, post vax. Y 09/13/2001 09/13/2001 0 PUB PUB Infant Motrin (1 Dropper at 09:30); Benadryl (2.5cc at 11:00) NONE NONE 1
0175510 09/19/2001 NH 7.0 7 M 09/12/2001 Pt developed hives, vomiting and diarrhea. The hives lasted for 2-3 hours. Rx: Benadryl Suspension. Y 03/28/2001 03/28/2001 0 PVT PUB NONE NONE Augmentin 1
0175511 09/19/2001 WI 57.0 57 M 09/06/2001 Persistent arthralgia noted since completing the Lyme vaccine series. The 2nd Lymerix vaccine was lot LY12069, in the RD on 5/14/99 and the 3rd Lymerix vaccine was lot LY144B9, in the LD on 5/5/00. U 04/15/1999 PVT OTH NONE Seasonal rhinitis; Psoriasis; T/P angioplasty; Increased lipids; Obesity 1
0175512 09/19/2001 NV 5.0 5 M 08/22/2001 Erythema on left arm at injection site. Y Y 08/20/2001 08/20/2001 0 PVT PUB NONE NONE NONE NV0108 1
0175513 09/19/2001 NV 4.0 4 M 08/09/2001 On 8/8/01, pt developed a fever and arm was pink and got worse in the evening. Went to ER; no labs but started on Keflex. On 8/9/01, pt's left arm was more red, more swollen about all of upper arm. On 8/10/01, redness was gone and on 8/11/01 and 8/12/01, swelling was down. Y Y 08/07/2001 08/08/2001 1 NONE PVT PUB NONE NONE NONE NV0109 1
0175514 09/19/2001 MO 2.0 2 .3 M 09/07/2001 On 9/5/01, 2 days ago, pt had URI symptoms, sore throat, clear nasal drainage. Also, had a spot on left lateral leg. Client continues to improve. Y 08/20/2001 09/05/2001 16 NONE PUB PUB 1 dose of Dimetapp on 9/4/01; no meds at time of shot NONE NONE ~Measles + Mumps + Rubella (no brand name)~~5.00~In Sibling MO2001049 1
0175515 09/19/2001 VA 11.0 11 F 09/07/2001 Pt fainted within 5 minutes of vaccine administration. Pt ran a fever no higher than 102.1F for 3 consecutive days. The pt maintained a sore throat for 3 consecutive days and experienced stomach irritation. Y 08/23/2001 08/23/2001 0 PUB UNK NONE NONE Pt has 1 kidney but is not considered a medical condition. 1
0175516 09/19/2001 LA 1.0 1 .0 F 09/10/2001 Pt developed urticarial lesions, 6 to 8 hours, post vax. Pt was afebrile and not sick looking. Treatment was Benadryl Elixir. Y 08/29/2001 08/29/2001 0 PVT PVT NONE Strabismus; Hemangioma on back 1
0175517 09/19/2001 FL 1.0 1 .0 M 09/06/2001 Pt developed a temperature of 102F, 25-30 fine, red papules on torso, back, neck, extremities and some with small vesicles and pustules on red bases. Also had flat vesicle on sole of feet. Y 08/27/2001 09/04/2001 8 NONE PVT PVT Septra NONE GI Reflux 1
0175518 09/19/2001 CA 14.0 14 F 07/25/2001 Post vax, pt fainted. Pt was breathing and moving extremities. Afterwards, used Ammonia inhalant and started to respond. Y 07/24/2001 07/24/2001 0 PUB PUB NONE NONE NONE CA010095 1
0175519 09/19/2001 CA 4.0 4 F 08/21/2001 Telephone call received from mother complaining of left arm swelling and redness, left arm and hand tenderness "painful to touch". Symptoms developed on 8/18/01. Child was taken to PMD. Mother states that the "doctor was unsure if symptoms were related to injections". Antibiotics were given. Y Y 08/16/2001 08/18/2001 2 UNK PUB PUB CA010094 1
0175520 09/19/2001 CA 12.0 12 M 08/24/2001 Pt developed an injection site rash (blotchy-red, non-itchy) which occurred 10 minutes, post vax. Y 08/24/2001 08/24/2001 0 OTH PUB CA010093 1
0175521 09/19/2001 CA 12.0 12 F Post vax, pt said she felt nauseous and immediately, her eyes rolled upward, she stiffened, went backward into my arms. I turned her head to the side, she was pale, cool and clammy and sweating. In 15 seconds, she came out of her state of faint and her BP was 120/86; pulse was 84 and respirations were 32. At 12:30, her BP was 110/86; pulse was 76 and respirations were 20. Her color was pink and she was alert. Mom is present. Y 08/24/2001 08/24/2001 0 OTH PUB NONE CA010092 1
0175522 09/19/2001 CA 5.0 5 F 08/23/2001 Reported here, 48 hours post vax, with left arm that had a area of 17cm X 18cm with erythema and induration. Pt complained of pain but no other symptoms. U 08/21/2001 08/21/2001 0 PUB PUB PPD/Connaught/C0153AA/LFA NONE CA010091 1
0175523 09/19/2001 FL 44.0 44 F 09/07/2001 Pt developed joint stiffness and swollen glands. U 08/31/2001 09/15/2001 15 PVT PVT NONE Allergy to Sulfa and Codeine 1
0175524 09/19/2001 CA 1.25 1 .3 F 09/06/2001 24-48 hours, post vax, pt developed 100 typical varicella spots. No known exposure. Fever went to 102F with no secondary causes. Y Y 07/25/2001 07/26/2001 1 NONE PUB PUB NONE NONE NONE 1
0175525 09/19/2001 IL 49.0 49 M 09/11/2001 Pt developed body aches, fatigue, fever, chills, mild headaches and was light-head. He is currently taking 20mg of Prednisone. On-going. Y N 07/25/2001 07/26/2001 1 Blood work and Indium Scans point to auto-immune reaction OTH PUB indomethacin Anklyosing Spondylitis 1
0175526 09/19/2001 NY 4.0 4 M 09/12/2001 On 9/11/01, pt's left leg was slightly swollen and red. On 9/12/01, pt had increasing swelling and redness and knee feels hot. Pt was given antihistamine and steroid. On 9/13/01, the pt is doing better today and has decreased swelling and redness. Y 09/10/2001 09/11/2001 1 PVT OTH NONE NONE 1
0175527 09/19/2001 FL 19.0 19 M 09/12/2001 Pt states, several hours post vax, he had a fever and a headache. On 9/12/01, he had a visit to PMD and states had fast pulse rate and BP was 180/100. Also stated, he had swollen glands in his neck and a headache. Y Y 09/07/2001 09/07/2001 0 PUB PVT NONE NONE 1
0175528 09/19/2001 TN 4.0 4 F 09/10/2001 Pt went to ER on 9/8/01 with left leg inflammation with induration around site 10cm in diameter and cellulitis of left leg. Rocephin 250 was given, Keflex and Benadryl per ER report. Y Y 09/06/2001 09/07/2001 1 CBC PVT OTH NONE Left otitis media 1
0175529 09/19/2001 VA 4.0 4 M 09/12/2001 Pt developed swelling and redness with streaks at DTAP site, 1 hour, post vax. It was tender to touch. Had onset of fever on 9/12/01 AM, 99F (oral). Y N 09/11/2001 09/11/2001 0 CBC-benign PVT PVT NONE NONE NONE 1
0175530 09/19/2001 TX 4.0 4 M 09/07/2001 The pt experienced redness, warmth to a 9 X 10 cm area of the right anterior thigh. No pain, no fever was noted. The redness began approximately 4 hours post vax. U 09/05/2001 09/06/2001 1 NONE PVT PVT NONE NONE 1
0175531 09/19/2001 WA 5.0 4 F 09/08/2001 1 hour post vax the pt developed pallor, lethargy, vomiting, urticaria. Was seen by a pediatrician and was already improving. Treated with oral antihistamine. The pt recovered completely within 24 hours. Y Y 09/05/2001 09/05/2001 0 NONE PVT PUB NONE NONE allergic conjunctivitis, atopic dermatitis 1
0175532 09/19/2001 TX 1.4 1 .4 M 09/10/2001 The pt experienced a whelp in the are of vax. The pt was scratching site. The parent was informed by the MD what to look for and to let him know of further reactions. U 09/10/2001 09/10/2001 0 PVT PUB NONE NONE 1
0175533 09/19/2001 MI 47.0 47 M 08/16/2001 40 minutes post vax, the pt called stating left arm numbness, shoulder and left facial numbness. Pt waited 30 minutes without side effects. The pt was advised to go to the ER, but pt did not go. Symptoms resolved the following evening. Y 08/14/2001 08/14/2001 0 NONE PVT OTH PPD / Connaught / C0578AA NONE NONE 1
0175534 09/19/2001 NJ 1.08 1 .1 F The pt experienced a hive the size of a dime at the injection site within 5 minutes post vax. No other symptoms observed. Benadryl was given. Parent was given instructions to follow-up if symptoms worsen. Y 09/12/2001 09/12/2001 0 NONE PVT UNK NONE NONE 1
0175535 09/19/2001 NJ 1.08 1 .1 F 09/14/2001 The pt experienced a hive which was seen 5 minutes post vax. The hive was the size o a dime. No there symptoms were noted. Benadryl was given for hives. Mom was given instructions to follow-up if symptoms worsened. Injection of varivax was given in the left leg, where hive opened. No other reaction. Benadryl was given. Y 09/12/2001 09/12/2001 0 NONE PVT UNK NONE NONE 1
0175536 09/19/2001 TX 1.0 1 .0 M 09/13/2001 1 week post vax, the pt experienced lethargy, anorexia, vomiting, rash on face and extremities and a 3 mm papular erythematous area. U 09/06/2001 09/11/2001 5 NONE PVT PUB URI vomiting and allergy to eggs 1
0175537 09/19/2001 GA 1.08 1 .0 M 09/12/2001 The pt experienced a vesicular rash for 1 day. Y U 09/04/2001 09/11/2001 7 NONE PVT PVT NONE eczema eczema 1
0175538 09/19/2001 VA 9.0 8 M 09/12/2001 Nausea and vomiting, fatigue, complains of chest tightness, headaches, sore throat. Has had clay colored stools (? asthma now). Still complains of chest tightness and trouble breathing. Y U 01/17/2001 04/01/2001 74 CXR PUB UNK NONE NONE NONE ~Hep B (no brand name)~2~10.00~In Sibling 1
0175539 09/19/2001 OK 42.0 42 F 09/10/2001 Severe abdominal pain 3 days following, elevated liver enzymes and bilirubin, continuing for 3 weeks, (so far). Y N 08/28/2001 08/31/2001 3 Blood tests (abnormal), UA (normal), HIDA Scan (Nml). PUB PUB Prevacid, Topamax, Vivactyl, Loestrin. Severe abdominal pain, nausea, and vomiting. Allergic to trees, grass, dust, mold. Possible multiple sclerosis. 1
0175540 09/19/2001 FL 4.0 4 F 09/11/2001 Mild early cellulitis, left deltoid 14 x 16 cm area of redness, swelling, unilateral good motion. Duricef given; changed to Cefzil. Y Y 08/27/2001 08/28/2001 1 PVT PVT Well visit. UNK ~DTaP (no brand name)~5~5.00~In Sibling 1
0175541 09/19/2001 CT 49.0 49 F 09/07/2001 This patient received MMR on 08/13/2001, developed joint aches, pain, swelling, on and off itching. "Chest pain" around 08/23/01. Seen 08/31/01 in the ER dept. Had Prednisone and lab work done, CBC, Sed rate, ANA, RF. Also seen 09/07/01, at employee health. Y N 08/13/2001 08/23/2001 10 Sed rate = 15, Rheumatoid factor = Neg, CBC = Nml, ANA = (+) 1:320, Rubella Titer + (-), 11/06/00. PVT UNK Diluent Sterile mixed in with MMR, lot # 1009K. Vioxx. PPD, Connaught, lot # C00824, left forearm, ID, on 08/10/01. Chronic joint pain. Arthritis - joint pain, allergic to sulfa, macrodantin. 1
0175546 09/20/2001 CA 1.0 1 .4 M 08/01/2001 This infant had a fever and vomiting starting 48 hours after vaccine. U 07/27/2001 07/30/2001 3 NONE OTH PUB Aerobid MDI NONE Down's Syndrome. CA010051 1
0175547 09/20/2001 NC 4.0 4 F 09/07/2001 This child had a 2 x 3-4 cm pink raised area on her upper right arm. Y Y 09/05/2001 09/05/2001 0 NONE PVT PUB NONE NONE NC01081 1
0175548 09/20/2001 CO 0.2 0 .2 M 09/11/2001 This infant had uncontrollable crying for 24 hours. No fever. Now resolving. Y Y 09/10/2001 09/10/2001 0 PVT PVT NONE NONE NONE 1
0175549 09/20/2001 IL 0.3 0 .3 F 09/17/2001 The pt experienced an abscess at the site of Comvax injection. Y Y 09/04/2001 09/05/2001 1 PVT PUB NONE NONE NONE 5 hours of crying~DTaP (no brand name)~1~0.20~In Patient 1
0175550 09/20/2001 VA 0.5 0 .5 F 09/14/2001 Mother reported that this infant developed red blisters on her right thigh and an elevated temperature (T 100.2 rectal and axillary) 24 hours after the injection. Currently right thigh has 40 mm x 45 mm induration. Rash on site. Site is healing. U 09/12/2001 09/13/2001 1 PUB PUB NONE UNK 1
0175551 09/20/2001 CA 4.0 4 F 08/13/2001 This child had a rash. Y 08/07/2001 08/08/2001 1 NONE PVT OTH NONE NONE Amoxicillin 1
0175552 09/20/2001 FL 43.0 43 M 09/12/2001 The pt experienced hives which started at the injection site and spread to torso. No wheezing was noted. The pt was brought to the office and given Solu Medrol and Benadryl, Medrol dose pak. Y Y 09/12/2001 09/12/2001 0 PVT OTH Proventil asthma 1
0175553 09/20/2001 UT 9.0 9 F 09/11/2001 The pt experienced a 103 degree fever, anorexia, fatigue, headache, malaise, nausea, vomiting, pain, vertigo, abdominal cramps, diarrhea, arthralgia, chills, flu-like symptoms, flushing, itching chin, and pain at injection site. Y 08/28/2001 08/28/2001 0 NONE PVT UNK NONE hayfever 1
0175554 09/20/2001 NJ 4.0 4 M 09/17/2001 approximately 2 minutes post vax, the pt had a seizure lasting less than a minute involving stiffness of extremities and falling to the floor. Incontinence of urine noted. Post-ictal after seizure. No fever, but due to fall contusion to left cheek. Y 07/24/2001 07/24/2001 0 EEG PVT PVT NONE NONE NONE 1
0175555 09/20/2001 WA 4 F 09/14/2001 The pt experienced 15 x 12 cm area redness / swelling. Y Y 09/10/2001 09/11/2001 1 NONE PVT UNK NONE NONE NONE 1
0175556 09/20/2001 PA 3.0 1 .5 F 09/14/2001 The pt experienced red papules with vesicles and excouatrons of various sizes. Treated with Benadryl. Y 03/23/1999 09/14/2001 906 PVT PVT NONE NONE NONO 1
0175557 09/20/2001 NC 1.0 1 .1 M 09/10/2001 The pt experienced puffy upper eyelids which developed 1/2 hour post vax. Y 09/10/2001 09/10/2001 0 PVT OTH NONE NONE NONE NC01082 1
0175564 09/21/2001 FL 1.2 1 .2 M 09/12/2001 Pt developed fever and excessive screaming and crying for a few hours, post vax, on 1/6/97. The annual follow-up states "autism." Y N 01/06/1997 01/06/1997 0 PVT PVT PPD/Neg on 1/6/97 NONE NONE 1
0175565 09/21/2001 AR 1.08 1 .1 M 08/24/2001 All of a sudden the pt developed a high fever and generalized tonic/clonic seizure-type movements on his way to the hospital. On the Wednesday before admission, he received immunizations. Quickly resolved his respiratory distress with frequent nebulizer treatments with albuterol, as well as, Atrovent, with 48 hours with Claforan IV. Also, IV methylprednisolone. Discharged home on albuterol 1/2 vial every 8 hours, Atrovent 1/2 vial ever 9 hours by nebulizer. Will continue Augmentin 3 1/2ml po every 12 hours X 10 days (200 mg/5ml), Prelone 2 1/2ml, 7 1/2mg po twice a day for 3 days. Mother to follow-up on Monday. Dx on discharge; febrile seizure, status post respiratory distress, status post crisis. Y Y Y 3 Y 08/15/2001 08/21/2001 6 48 hour blood cultures-neg; initial CBC showed WBC at 15,000; Hgb-11.5, platelets-401; differential segs 36, 42 lymphocytes, atypical lymphocytes 2. Basic metabolic panel initially with sodium of 133, potassium of 4.8, chloride of 95, CO2-17, glucose 232, BUN 19, creatinine of 0.6, calcium of 9.1. Repeat basic metabolic panel showed sodium 139, potassium 4.7, chloride 102, CO2 25, and glucose 112, BUN 17, creatinine 0.3 and calcium 9.5. Clinically temperature 96.5F, heart rate 120, respiratory rate of 24. O2 sat on room air 100%. PUB UNK NONE NONE Asthma AR3601 1
0175566 09/21/2001 NV 50.0 50 F 09/13/2001 The pt complained of throat tightness, swelling of hands and feet, rash and developed difficulty breathing. There was burning at the injection site with a hot feeling. She complained of itching at hands and mouth and dryness of throat. Fever of 100F. Y Y Y 09/12/2001 09/12/2001 0 NONE PUB PVT NONE Mild cold. Allergies to Demerol, Epinephrine, formaldehyde, shrimp, perfumes, pesticides, PCN and numerous antibiotics. 1
0175567 09/21/2001 MA 1.25 1 .3 M 09/17/2001 Allergies, asthma and cough Y Y N 07/09/1996 07/10/1996 1 PUB PUB 1
0175568 09/21/2001 CA 2.0 2 .9 M 08/30/2001 Pt developed a red induration on left arm. Y 08/28/2001 08/30/2001 2 NONE PUB PUB NONE NONE NONE CA010096 1
0175569 09/21/2001 ID 0.5 0 .5 M 08/17/2001 A 6 month old male with fussiness, fever of 102.2 F, left leg pain, and a 2 x 5 cm elliptical rash distal to DTaP and Hib injection sites. Occurred within 24 hours of the injection. Remains fussy 48 hours later, now with URI, symptoms and rash on inner left thigh, left axillae and less confluent but more widespread around the injection sites. Mental status appropriate, leg still painful at 48 hours. Y U 08/15/2001 08/15/2001 0 PVT UNK ID01042 1
0175570 09/21/2001 MS 0.9 0 .9 F 09/07/2001 Mom picked up child, out of crib about 08:00 on 9/6/01. She noticed the back of both legs from the middle of the thighs to the middle of the calves were red, swollen and blotchy. The rash progressed throughout the day to spread to chest, under arms, on thumb, finger and ankle. Afebrile with no wheezing or cough. Child was happy and playful and scratching rash, itchy and hive-like. The rash disappeared on 9/7/01 about mid-morning after 2 doses of Benadryl. Seen in office on 9/7/01 and 9/15/01. Y Y 09/05/2001 09/06/2001 1 NONE PVT PUB Finished Bactrim about 24 hours before dose of Prevnar then gave Benadryl. Allergy to Omnicef which causes a rash. Increased irritability~Pneumo (Prevnar)~2~0.50~In Patient MS01039 1
0175571 09/21/2001 VT 4.0 7 F 09/19/2001 6 x 9 inch irregular shaped red, swollen area right upper arm. Y 09/17/2001 09/18/2001 1 PVT PVT NONE NONE 1
0175572 09/21/2001 CA 31.0 31 M 09/14/2001 Patient reported having soreness in right arm, following administration of vaccine. The patient states his right arm is weak and he has trouble lifting objects that are heavy. The patient is a drummer and states he has trouble approx 1 hour into his performing. The patient states he can feel a small "knot" at the site of the injection. N 06/18/2001 06/18/2001 0 PUB PVT NONE NONE 1
0175573 09/21/2001 CO 46.0 46 M 08/22/2001 At 3:15 PM, itching and redness of the right arm (back of arm). At 3:25 PM, "bubbles" and blotches on the right arm. At 3:45 PM, "bubbles" and blotches covered the entire right arm and the left arm started went to the knees and legs then covered the whole body. At 4:45 PM, at the doctors, trouble with vision, passed out, O2 at 87 %. Treatment O2, Nebulizer, Benadryl IM, Prednisone PO, Allegra, and Zantac. Y Y 08/21/2001 08/21/2001 0 NONE PUB PUB NONR NONE Allergic to Penicillin. CO01017 1
0175574 09/21/2001 NE 64.0 64 F 09/12/2001 TD was given 09/04/2001. On 09/11/01, The patient noticed large, edematous, red , warm and itchy area over the injection site. Prescribed ice compress. On 09/12/01, came in this AM. site was 12 x 7 cm with 2 small satillites over elbow. No body rash, no systemic reaction, no fever. Y 09/04/2001 09/06/2001 2 NONE OTH OTH Prempro NONE NONE 1
0175575 09/21/2001 NY 11.0 11 M 09/17/2001 The child complained of severe headaches, extreme fatigue, muscle aches and heaviness in arm/legs bilaterally. Symptoms persisted until 4/01 and slowly abated. Y Y 11/13/2000 12/15/2000 32 CBC, T4 - both wnl PVT PVT NONE hx of chicken pox (10 days prior to 1st hepB vax) 1
0175576 09/21/2001 OH 38.0 38 F 09/14/2001 The shot didn't feel cold like the last one that was administered by doctor. A burning spot developed on arm opposite of shot by wrist after rash to neck, jaw. Burn spot still there as of the 7th and is larger. Arm where shot was give was swollen from the shot for 2 weeks. Now it is dark, neck may be larger. The pt experienced chest or lung pain. The pt experienced a bloody nose, liver felt swollen. Y U 08/27/2001 08/28/2001 1 UNK UNK NONE UNK 1
0175577 09/21/2001 SD 1.0 1 .0 F 09/20/2001 Approximately 10 days after MMR and Varivax injections, began having fevers 104 105. Demonstrated a maculopapular rash. Y U 09/07/2001 09/17/2001 10 Doctor reported blood tests were done indicating "viral infection". PVT OTH 1
0175578 09/21/2001 FL 4.0 4 M 09/20/2001 Edema, erythema 6 cm x 6 cm, tender left mid thigh. Y Y 09/18/2001 NONE PVT PUB NONE Short stature 1
0175579 09/21/2001 SD 5.0 5 F 09/12/2001 The pt received vax's on 8/27/01. On 9/5/01 the child's mother called on symptoms child was experiencing. The child experienced a fever and rash on trunk characterized pox-like eruptions. Upon follow up the pox began to scab over and dry up. Pox were on trunk only. Y 08/29/2001 09/05/2001 7 PVT PUB NONE NONE NONE 1
0175580 09/21/2001 FL 18 M 09/07/2001 The pt experienced lightheadedness, 2 hours later felt faint and proceeded to the ER. The pt's throat then tightened and became short of breath. The pt was treated with Ativan. Y Y 09/05/2001 09/05/2001 0 CBC OTH PUB NONE Slight cold NONE 1
0175581 09/21/2001 AR 1.08 1 .1 M 08/23/2001 The grandmother reported that her son called and told her the baby started jerking all over and his eyes rolled back which lasted seconds. The pt was going to the pediatrician today. Y Y 08/20/2001 08/23/2001 3 PUB PUB runny nose AR3501 1
0175582 09/21/2001 CA 12.0 12 M 09/17/2001 One day post vax the pt called the health department stating that when son woke up in the morning his upper lip was swollen. No difficulty breathing or swallowing. . Y Y 09/04/2001 09/05/2001 1 PUB PUB NONE hx of allergy 1
0175583 09/21/2001 NV 71.0 71 F 09/04/2001 The pt complained of swelling of the upper lip only 1 day post vax. the swelling resolved 1-2 days after it appeared. No other symptoms. Y 08/28/2001 08/29/2001 1 NONE PUB PVT Lasix, Nose drops, Premarin feeling tired asthma, sinus problems, allergy to PCN 1
0175584 09/21/2001 CA 4.0 4 M 09/07/2001 The child complained he felt cold and was shivering. His hands and feet were very cold to the touch while his face was hot. He had extreme pallor and his lips were a light blue color. He stated he felt bad and asked to lie down. He was given 2 chewable children's Tylenol. The cyanosis persisted for 15 minutes. The fever lasted 2 hours after the Tylenol dose. The child felt better after 4 hours and resumed his normal activities. Y 09/06/2001 09/07/2001 1 PUB PUB NONE NONE NONE CA010097 1
0175585 09/21/2001 NM 3.0 3 M The pt experienced a 5 x 3 area of erythema which was flat, warm on the upper arm. The pt was seen 2 days post vax. Treated with Benadryl. Y Y 08/16/2001 OTH UNK NONE 1
0175586 09/21/2001 VA 11.0 12 M 08/31/2001 After receiving the vax, the pt returned to waiting room. He sat down in there and reported feeling sick to his stomach the his body stiffened and his eye rolled back. He was lowered to the floor near the waiting room. Mother reported the child was unresponsive for several seconds. The skin was warm, moist and pale in color. Y Y 08/29/2001 08/29/2001 0 vital signs, EKG - wnl, Blood glucose level - low PUB OTH NONE NONE NONE VA01029 1
0175588 09/21/2001 CA 10.0 9 M 09/13/2001 The pt experienced swelling, redness. Y Y 09/10/2001 09/12/2001 2 NONE PVT PVT PPD / C0832AA NONE NONE 1
0175589 09/21/2001 VT 1.5 0 .5 F 09/14/2001 The pt experienced a red, hot raised area to the left mid thigh. U 09/12/2000 09/13/2000 1 NONE MIL UNK NONE NONE 1
0175590 09/21/2001 CA 1.6 1 .6 F 09/10/2001 The pt experienced a 7x7 cm red, swollen, raised are to the right anterior thigh. Y Y 09/05/2001 NONE PVT OTH NONE NONE NONE 1
0175591 09/21/2001 LA 14.0 14 F 08/22/2001 Mother states on return visit with other child that the pt complained of chest pain and palpitations and "felt bad" and had "sweating" lasting about 30 minutes beginning about 1 1/2 hour after vax was given. The pt had another episode about 24 hours post vax. This episode did not last as long as the 1st episode. Y 07/25/2001 07/25/2001 0 PUB PUB NONE LA010901 1
0175592 09/21/2001 NV 28.0 28 F 09/13/2001 The pt complained of weakness, dizziness, fatigue, cold and flu like symptoms for 7-10 days. Still complains of dizziness. U 08/16/2001 08/16/2001 0 PUB PVT multivitamins, Klonipin NONE NONE 1
0175593 09/21/2001 CA 0.25 0 .3 F 05/03/2001 It was reported that a 3 month old female infant received a Tripedia, a Prevnar, a Hib-Titer and an IPOL vaccination on 2/28/01 at 18:00 PM. At 18:03 PM, this pt was limp, hyporesponsive, pale and lethargic. She was crying, intermittently, to stimulation but persistent stimulation for 5-10 minutes, brought her out of that state. Paramedics came, pt went to ER and was discharged. From additional correspondence received on 4/19/01, it was reported, "Reviewed, no additional information at this time". This case is closed. Y Y 02/28/2001 02/28/2001 0 NONE PVT OTH Common cold Common cold U2001004980 1
0175594 09/21/2001 UT M 05/16/2001 It was reported that a pt (1 of 3) received a Tripedia vaccination, date not specified. Reportedly, 24-48 hours, post vax, the pt developed a local reaction of swelling, redness and erythema at the injection site. Further information is requested. From additional correspondence received on 5/7/01, it was reported that the pt recovered from this experienced. Additional pt, vaccine, vaccine administrator and responsible physician information was also provided. Y NONE PVT PVT NONE NONE U2001005550 1
0175595 09/21/2001 CT 4.0 4 M 04/20/2001 It was reported that a patient (1 of 3) received a Tripedia vaccination, date not specified. Reportedly sometime after the vaccination the patient developed a local reaction. Further info is requested. From additional correspondence received on 03/23/01, it was reported that at approximately 24 hours after injection, the patient developed swelling and erythema at the site, quarter size. At 48 hours, erythema, heat and induration 14 x 10 cm. The patient has not yet recovered. N 03/20/2001 03/22/2001 2 NONE PVT PVT NONE NONE U2001005400 1
0175596 09/21/2001 CT U 05/18/2001 It was reported that a pt (2 of 3) rec'd a Tripedia vaccination, date not specified. Reportedly sometime after the vaccination the pt developed a local reaction. Further information is requested. Per telephone conversation with DA, LPN on 3/27/01 it was reported that patient 2 of 3 received Tripedia from the same vial as pt 1 0of 1 (U2001-00540). The lot # of Tripedia in report U2001-00540 was reported as U0039CA. LPN DA reported that (2or 3) other children had rec'd vaccine from this vial without reactions. Apparently, pt 2 of 3 had a little erythema "physician chose not to complete VAERS form for patient 2 of 3. requested further information. On 3/28/01. From additional correspondence rec'd 4/16/01, no new information was provided. From additional correspondence rec'd on 5/14/01, it was reported from phone call and conversation with the pt's father several days after the onset of the reaction the father stated. Fully recovered. No erythema, no fever, no pain, acting fine. This case is closed. Y NONE PVT PVT NO NONE U2001005410 1
0175597 09/21/2001 CT U 04/20/2001 It was reported that a pt (3 of 3) received a Tripedia vaccination, date not specified. Reportedly, sometime after the vaccination, the pt developed a local reaction. Further information is requested. Per telephone conversation with LPN on 3/27/01, it was reported that 3 of 3 received Tripedia in unit dose form. Apparently, pt 3 of 3 had a "little erythema". Physician chose not to complete VAERS form for pt 3 of 3. Request further information. From additional correspondence received on 4/16/01, no new information was provided. U NONE PVT PVT NONE NONE U2001005420 1
0175598 09/21/2001 PA 4.0 4 F 05/03/2001 It was reported that a 4 year old pt (1 of 3) received a Tripedia vaccination and reportedly, sometime after the vaccination, the pt developed a 3" local reaction at the injection site. Further information is requested. From additional correspondence received on 4/26/01, it was reported that the pt received the Tripedia vaccination as well as an IPOL and a MMR vaccination on 3/27/01. The pt reportedly, recovered from this experience. This case is closed. Y 03/27/2001 PVT PVT NONE NONE U2001005520 1
0175599 09/21/2001 PA 4.0 4 M 05/03/2001 It was reported that a 4 year old pt (2 of 3) received a Tripedia vaccination and reportedly, sometime after the vaccination, the pt developed a 3" local reaction at the injection site. Further information is requested. From additional correspondence received on 4/26/01, it was reported that the pt received the Tripedia as well as an IPOL and a MMR vaccination on 2/23/01. Reportedly, the pt recovered. This case is closed. Y 02/23/2001 PVT PVT U2001005530 1
0175600 09/21/2001 PA 4.0 4 F 05/03/2001 It was reported that a 4 year old pt (3 of 3) received a Tripedia vaccination. Reportedly, sometime after the vaccination, the pt developed a 3" local reaction at the injection site. Further information is requested. From additional correspondence received on 4/26/01, it was reported that the pt received the Tripedia as well as an IPOL and a MMR vaccination on 3/25/01. The pt reportedly recovered from the adverse event. This case is closed. Y 03/25/2001 PVT PVT NONE NONE U2001005540 1
0175601 09/21/2001 UT U 05/16/2001 It was reported that a pt (3 of 3) received a Tripedia vaccination, date not specified. Reportedly, 24-48 hours, post vax, the pt developed a local reaction of swelling, redness and erythema at the injection site. Further information is requested. From additional correspondence received on 5/7/01, it was reported that the pt is unknown. U UNK UNK U2001005570 1
0175602 09/21/2001 CA 4.0 4 F 05/21/2001 It was reported that a pt (1 of 9) received a Tripedia vaccination the week of 3/23/01. Reportedly, sometime after the vaccination (date not specified) the pt developed a large local reaction at the injection site. From additional correspondence received on 5/16/01, additional pt, vaccine administrator and responsible physician information was provided. U 03/23/2001 UNK UNK U2001005830 1
0175603 09/21/2001 CA 5.0 4 F 05/21/2001 It was reported that a pt (2 of 9) received a Tripedia vaccination the week of 3/23/01. Reportedly, sometime after the vaccination (date not specified), the pt developed a large local reaction at the injection site. From additional correspondence received on 5/16/01, additional pt, vaccine administrator and responsible physician information was provided. U 03/23/2001 UNK UNK U2001005840 1
0175604 09/21/2001 CA 5.0 4 F 05/21/2001 It was reported that a pt (3 of 9) received a Tripedia vaccination the week of 3/23/01. Reportedly, sometime after the vaccination (date not specified), the pt developed a large local reaction at the injection site. From additional correspondence received on 5/16/01, additional pt, vaccine administrator and responsible physician information was provided. U 03/23/2001 UNK UNK U2001005850 1
0175605 09/21/2001 CA 5.0 4 M 05/21/2001 It was reported that a pt (4 of 9) received a Tripedia vaccination the week of 3/23/01. Reportedly, sometime after the vaccination (date not specified), the pt developed a large local reaction at the injection site. From additional correspondence received on 5/16/01, additional pt, vaccine administrator and responsible physician information was provided. U 03/23/2001 UNK UNK U2001005860 1
0175606 09/21/2001 CA 4.0 4 F 05/21/2001 It was reported that a pt (5 of 9) received a Tripedia vaccination the week of 3/23/01. Reportedly, sometime after the vaccination (date not specified), the pt developed a large local reaction at the injection site. From additional correspondence received on 5/16/01, additional pt, vaccine administrator and responsible physician information was provided. U 03/23/2001 PVT UNK NONE NONE U2001005870 1
0175607 09/21/2001 CA 4.0 4 F 05/21/2001 It was reported that a pt (6 of 9) received a Tripedia vaccination the week of 3/23/01. Reportedly, sometime after the vaccination (date not specified), the pt developed a large local reaction at the injection site. From additional correspondence received on 5/16/01, additional pt, vaccine administrator and responsible physician information was provided. U 03/23/2001 PVT UNK U2001005880 1
0175608 09/21/2001 CA U 05/21/2001 It was reported that a pt (7 of 9) received a Tripedia vaccination the week of 3/23/01. Reportedly, sometime after the vaccination (date not specified), the pt developed a large local reaction at the injection site. From additional correspondence received on 5/16/01, it was reported, "unable to locate pt name". This case is closed. U 03/23/2001 UNK UNK U2001005890 1
0175609 09/21/2001 CA U 05/21/2001 It was reported that a pt (8 of 9) received a Tripedia vaccination the week of 3/23/01. Reportedly, sometime after the vaccination (date not specified), the pt developed a large local reaction at the injection site. From additional correspondence received on 5/16/01, it was reported, "unable to locate pt name". U 03/23/2001 UNK UNK U2001005900 1
0175610 09/21/2001 CA U 05/21/2001 It was reported that a pt (9 of 9) received a Tripedia vaccination the week of 3/23/01. Reportedly, sometime after the vaccination (date not specified) the pt developed a large local reaction at the injection site. From additional correspondence received on 5/15/01, it was reported, "unable to locate pt name". U 03/23/2001 UNK UNK U2001005910 1
0175611 09/21/2001 FL 1.4 F 04/19/2001 It was reported that a 17 month old female pt received a Tripedia vaccination on 4/4/01. Reportedly, that same day, the pt developed a local reaction of swelling, redness and ecchymosis. Physician dx'd as cellulitis and treated with Augmentin. Y U 04/04/2001 04/04/2001 0 UNK UNK U2001006460 1
0175612 09/21/2001 CA 1.9 2 .8 F 04/19/2001 It was reported that a female pt received a Tripedia vaccination on 4/3/01. Reportedly, on 4/4/01, the pt developed swelling, redness, induration and blistering. Physician treated with Keflex to be safe. Reaction resolved by 4/7/01. Y Y 04/03/2001 04/04/2001 1 UNK UNK U2001006470 1
0175613 09/21/2001 TX 1.5 F 05/03/2001 It was reported that an 18 month old female pt received her 1st Tripedia vaccination on 12/3/99. Reportedly, the pt develope "severe" swelling at the injection site. "Her leg was very red and hot, and she would also scream for more than 3 hours at a time. When she got her 2nd dose on 2/3/00, the same thing happened." The reporter switched physicians and the "3rd dose was administered in 2 half doses with Benadryl on 8/23/00 and 9/23/00 and no problems occurred." U 12/03/1999 UNK UNK U2001006770 1
0175614 09/21/2001 VA 0.08 0 .1 M 05/14/2001 It was reported that a 1 month old infant pt received a Tripedia vaccination on 5/7/01. Reportedly, that same day, the pt presented with a high-pitched scream, his left upper thigh was red and swollen greater than 10mm. Refused feeding, his temperature with Tylenol was 99.3F. His right thigh was 6.5" and his left thigh was 7". U 05/07/2001 05/07/2001 0 UNK UNK U2001007120 1
0175615 09/21/2001 IL 1.5 U 05/21/2001 It was reported that a pt (2 of 3) received a Tripedia vaccination (date not specified). Reportedly, the pt developed a local reaction at the injection site (onset date not specified). U UNK UNK U2001007350 1
0175616 09/21/2001 IL 4.0 U 05/21/2001 It was reported that a pt (2 of 3) received a Tripedia vaccination (date not specified). Reportedly, the pt developed a local reaction at the injection site (onset not specified). U UNK UNK U2001007360 1
0175617 09/21/2001 IL 4.0 U 05/21/2001 It was reported that a pt (3 of 3) received a Tripedia vaccination (date not specified). Reportedly, the pt developed a local reaction at the injection site (onset date not specified). U UNK UNK U2001007370 1
0175618 09/24/2001 CA 0.2 0 .2 F 09/19/2001 Received a letter from an RN, PHN 09/19/01, saying that this infant died on 09/01/01 with preliminary diagnosis of Sudden Infant Death Syndrome. Did not know of patient death prior to the letter. Death certificate states cause of death as "pending" and autopsy performed. Y 09/01/2001 N 08/30/2001 09/01/2001 2 No report from the coroner. PVT PUB NONE NONE 1
0175622 09/24/2001 NY 45.0 43 F 09/17/2001 Gradual onset of Lyme disease-like symptoms: joint pain, numbness and tingling in the extremities, headache, flu-like symptoms, back pain, memory loss, etc. Ongoing treatment for Lyme disease. Follow up on 08/06/03: "Vaccine recipient did not recover from adverse events. Still has all symptoms." Y Y N 05/03/1999 10/01/1999 151 PVT PVT 1
0175623 09/24/2001 TX 0.2 0 .2 F 09/17/2001 Pt developed crying for 6 hours, post vax, at 2 month immunizations of DTAP, IPV, HIB and PCV. DT was given at 4 months. Y 07/12/2001 07/12/2001 0 PVT PVT 1
0175624 09/24/2001 CT 1.08 1 .0 M 09/21/2001 Pt developed a fever of 103F-104F which started 4 hours, post vax, lasting 45 days. No other signs or symptoms. On exam, site was redder that other shots he ever had. Y 07/30/2001 07/30/2001 0 NONE PVT PVT NONE NONE NONE CT200105 1
0175625 09/24/2001 OR 1.25 1 .3 M 08/29/2001 This child woke up on 8/29/01 with a rash or hives on his left trunk. Skin was cool to touch. No vomiting or other symptoms. Reported to PMD for evaluation and he recommended Tylenol and Benadryl if hives persist. On 8/31/01, telephone call to mother and she reported that hives had increased to full body but now are resolving. Temperature went to 101F (axillary) but now resolved. Y Y 08/28/2001 08/29/2001 1 NONE PUB OTH Benadryl; Tylenol NONE NONE OR200134 1
0175626 09/24/2001 WV 0.3 0 .3 M 09/17/2001 Note: First time in this clinic but 2nd immunizations. Had same immunizations, 2 months before at another clinic. Autopsy results state cause of death to be SIDS. Y 09/08/2001 Y N 09/06/2001 MIL PVT NONE 1
0175627 09/24/2001 HI 1.0 1 .0 F 09/15/2001 Pt had swelling at the site of PCV7 injection of 5cm X 6.5cm, 48 hours, post vax. U 09/13/2001 09/14/2001 1 PVT PVT NONE 1
0175628 09/24/2001 CA 49.0 49 M 09/12/2001 Marked swelling, redness, warmth and tenderness to immunization site. Treated with Motrin, Benadryl and Keflex. Y Y 09/09/2001 09/10/2001 1 NONE MIL MIL Zestril NONE Hypertension 1
0175629 09/24/2001 CA 49.0 49 F 09/12/2001 Localized redness, swelling, itching and hemorrhage (bruising). Treated with Benadryl and Motrin. Y Y 09/09/2001 09/10/2001 1 NONE MIL MIL Medroxyprogesterone, Premarin NONE Allergy to Sulfa, Keflex, Erythromycin and Macrodantin 1
0175630 09/24/2001 CA 23.0 41 M 09/12/2001 Pt developed a 4cm localized redness, swelling and itching to vaccine site. Treated with Benadryl and Motrin. Y Y 09/09/2001 09/10/2001 1 NONE MIL MIL NONE NONE NONE 1
0175631 09/24/2001 MA 46.0 46 F 09/12/2001 The pt experienced a blotchy red rash to the cheeks and forehead. The pt also experienced diarrhea, lack of appetite, hot flashes, some blurred vision, evaluated by PCP. No treatment ordered. Used cold pack over rash to relieve itching. Y Y 08/03/2001 09/04/2001 32 NONE PVT PUB Zoloft, Synthroid, Ultram, Naproxen, Estradiol NONE allergy to mold, pollen, hayfever, bees, hypoglycemia, angina, asthma, arthritis 1
0175632 09/24/2001 OR 1.3 1 .3 F 08/24/2001 The pt experienced a fever of 102-104 the same day of the vax until 4 days post vax and then experienced a low grade fever for 3 more days. The pt experienced fussiness, congestion, was achy, had cold hands and feet. Y 08/14/2001 08/14/2001 0 CBC, blood culture PVT PUB NONE NONE OR200135 1
0175633 09/24/2001 CA 0 1 F 09/10/2001 The pt experienced varicella. Y 09/30/1998 UNK UNK 1
0175634 09/24/2001 KY 1.08 1 .1 F 09/13/2001 Within 2 weeks, the pt experienced typical pox lesions. Y U 08/24/2001 09/09/2001 16 PVT PVT NONE 1
0175635 09/24/2001 MN 32.0 32 M 08/29/2001 The pt experienced swelling, redness, warmth over right deltoid, malaise, chills, low grade fever and not associated URI. Y U 08/27/2001 08/28/2001 1 CBC PVT PVT NONE finger lacerations NONE 1
0175636 09/24/2001 IA 0.25 0 .2 F 09/11/2001 The pt developed a mass a bit larger than a quarter on her thigh at the injection site which lasted for 2 weeks. It was also red, swollen and sore. Y 08/21/2001 08/22/2001 1 PVT PVT NONE NONE NONE 1
0175637 09/24/2001 NY 0.5 0 .5 M 09/21/2001 The pt experienced high pitched crying for 5 hours and was inconsolable. No fever was present. The following day, he was irritable and hoarse. An exam revealed no other source. Y 09/18/2001 09/18/2001 0 PVT PUB NONE NONE NONE CT200106 1
0175638 09/24/2001 CA 0.75 0 .8 F 09/10/2001 The pt had a temperature and was vomiting a large amount of fluid. The child cried at times but was alert. The parent was told that if the vomiting continues, get the baby to an urgent care facility. U 09/07/2001 09/09/2001 2 PUB PUB NONE NONE CA010098 1
0175639 09/24/2001 CA 15.0 15 M 09/10/2001 Within 10 minutes post vax the pt stood up and fainted and fell on the floor on his back and hit his head and sustained a small abrasion. The pt was pale and not responding within a few seconds only. The pt's blood pressure was 100/62. The pt began responding after a few seconds. The pt was place with his feet elevated. No additional complaints were noted. Y 09/10/2001 09/10/2001 0 NONE PUB PUB NONE NONE CA010099 1
0175640 09/24/2001 ND 2.0 1 .0 M 09/14/2001 The pt developed a mild case of chicken pox and had a full recovery. Y 12/20/1999 08/27/2001 616 PVT UNK 1
0175641 09/24/2001 TX 3.0 3 F Pt developed generalized rash with "whelps", 24 hours, post vax of Hep-A vaccine and a fever of 102F, Her eyes and tummy hurt and said it hurt to be touched. Seen at clinic and given Benadryl and rash resolved. Seen 1 week later for OM. Y Y 09/11/2001 09/12/2001 1 NONE OTH PUB NONE NONE NONE 1
0175642 09/24/2001 OH 4.0 4 M 09/11/2001 The pt experienced sneezing, itching at eyes and face turned red, hives appeared on face and neck. Y Y 09/10/2001 09/10/2001 0 PUB PUB NONE NONE 1
0175643 09/24/2001 OR 0.8 0 .8 M 09/17/2001 The pt experienced blisters, rash, hives to the left leg and left arm which were also red, warm to the touch. Mom states some new redness and swelling at the site. Not anything like the present reaction. Treated with Benadryl. Y Y 09/12/2001 09/13/2001 1 NONE PUB UNK NONE NONE NONE redness and swelling~DTaP (Tripedia)~~0.00~In Patient 1
0175644 09/24/2001 CA 16.0 16 F 09/14/2001 The pt experienced localized swelling, increased warmth with slight erythema and tenderness. U 09/13/2001 09/13/2001 0 NONE MIL OTH NONE NONE NONE 1
0175645 09/24/2001 VA 2.0 M 09/11/2001 The pt developed a know in his left leg 3 days post vax. The pt complains of left leg pain and the knot is the size of a quarter. He now has a yeast infection on his bottom. U PUB PUB candida, swollen ear, skin allergies skin allergies and candida per mother 1
0175646 09/25/2001 CA 3.0 F 12/03/2001 Information has been received from a consumer concerning his 3 year old granddaughter who about 6 years ago, in approx. 1995, was vaccinated with 1 dose of varicella virus vaccine live. Ten days to 2 weeks, post vax, the child manifested symptoms of encephalopathy, resulting in incoordination. She was taken to her pediatrician and was referred to a specialized hospital. She was found to have hyperammonemia and was dx'd with ornithine transcarbamoylase deficiency (OTC). The condition resulted in hospitalization. It was reported that the pt was treated for this condition for 6 years, but died in 2/01. The reporter stated that he did not "suspect cause and effect", but felt that varicella virus vaccine live triggered events and exposed the OTC. Additional information has been requested. Per F/U; information has been received from a health care professional concerning his 3 year old granddaughter who on 9/8/95 was vaccinated with 1 dose of varicella virus vaccine live (lot 608582/0410B). Ten days to 2 weeks, post vax, the child developed ataxis and was thought to have encephalopathy. She was taken to her pediatrician and was referred to a specialized hospital. She was found to have hyperammonemia and was dx'd with "de nova or a primary mutation of" ornithine transcarbamoylase deficiency (OTC), a urea cycle disorder, which the reporter felt was the "most likely cause of the elevated plasma ammonia and the encephalopathy. The condition resulted in hospitalization, on an unspecified date. The reporter stated he did not "suspect cause and effect" but felt that varicella virus vaccine live triggered events and exposed the OTC. F/U info was received on 10/11/01 from the initial reporter and he stated his granddaughter was a normal, healthy child, including no known history of immunosuppression prior to the events reported. She had no signs or symptoms of OTC prior to vaccination. He stated that his granddaughter died of "gross medical mismanagement", by some of the treating physicians, as well as, the managed care healthcare system. He reaffirmed that he did not necessarily believe there was a direct cause and effect relationship between vaccination with varicella virus vaccine live and the development of OTC deficiency; however, since the vaccine is a live virus, he wondered about the possibility of the vaccine "triggering" some type of response which lead to the manifestation of the OTC deficiency order. On 10/19/01, a retired office nurse, from the vaccinating physician's office, indicated that the child was only seen in their office for a short time and then transferred to another physician. Additional information has been requested. The adverse experience of blood urea decreased has been removed as an adverse experience. Follow-up medical records received from a physician on 11/20/2001 indicated that the pt had been seen in his office on 09/19/1995. The physician noted that the pt was not administered the vaccination at his office, but that she received the vaccination 10 days prior to her presentation at another clinic. It was reported that on Sunday, the pt was fussy and acted as if dizzy or off blalance. She was eating well. The pt was seen int eh ER the night before her presentation to the physician and "woke up" with a temp of 96.8 F. It was ntoed that the pt was "off balance" the morning of her exam. The pt was irritable, whiny and couldn't be pleased. She acted "drunk" and "staggered some." No fever or vomiting were present. It was reported that at am pre-school on Monday the pt seemed normal. A call was placed from a physician in the afternoon were it was noted that the pt was irritable, whiny and crying. At 5pm the pt staggered and ran into a car. That evening the pt was seen again in the ER. It was reported that the pt needed catheterization for a urinalysis and had a drug screen, an electrolyte screen and a CBC. An abdominal x-ray was "OK." On Thursday am the pt bumped into a wall and had an "unstable balance." It was noted that she was extra whiny and fussy. Her appetite and drinking were "OK." Her speech had changed and she was "harder to understand." A physician exam revealed the pt to have had a mild truncal ataxia. The pt was referred to the hospital for diagnostic work-up and treatment. No further info is available. Y Y Y N 09/08/1995 Diagnostic lab-hyperammonemia; physical examination-mild truncal ataxia PUB OTH UNK UNK WAES01091716 1
0175647 09/25/2001 PA 8.0 F 12/19/2001 Information has been received from a consumer concerning an approx. 7 year old female who about 2 years ago, in approx. 1999, was vaccinated with 1 dose of varicella virus vaccine. In approx. 1999, the pt developed hyperammonemia and died. Additional information has been requested. F/U information, received on 10/11/01, from the healthcare professional, indicated that "subsequent to the initial encephalopathy (the child was) dx'd with de novo or a primary mutation of ornithine transcarbamoylase deficiency (OTC), which was most likely the cause of the elevated plasma ammonia and the encephalopathy". He further indicated that he did not necessarily believe there was a direct cause and effect relationship between vaccination with varicella virus vaccine live and the development of OTC deficiency; however, since the vaccine is a live virus, he wondered about the possibility of the vaccine "triggering" some type of response which lead to the manifestation of the OTC deficiency disorder. Additional information has been requested. Follow-up info received on 11/30/2001 from a physician indicated that the pt was 8 years old, white, weighed 42 lbs, and was 45" tall. The pt who had no past medical history and no known allergies, was vaccianted SC on 08/13/1999 with the first dose of varicella virus vaccine live. It was reported that the pt's experience began on 09/20/1999. The physician indicated that the pt died on 10/23/1999 from multiple organ failure after being diagnosed with OTC. No further info is available. Y 10/23/1999 Y N 08/13/1999 09/20/1999 38 Diagnostic laboratory-hyperammonemia PVT PVT UNK NONE WAES01091751 1
0175648 09/25/2001 NJ 19.0 18 F 09/20/2001 Earache; diarrhea and vomiting; on menses. CDC confirmed and notified in 9/01 that the cause of death as fulminant meningococcus. Typing was C from ear drainage. Autopsy results received confirming this also. Y 12/18/2000 N 10/15/1999 12/18/2000 430 CDC did immuno-chemistry histology stains that confirmed cause of death as fulminant meningococcus. Typing was C from ear drainage. She was 19 at the age of her death. OTH PUB NONE NONE NONE 1
0175657 09/25/2001 12.0 4 M 09/18/2001 Information has been received from a lawyer concerning a 12 year old male pt who on 7/11/89 and 8/20/92 was vaccinated with a 1st and 2nd dose of MMRII and diphtheria (+) tetanus. It is alleged that the aforementioned vaccines were contaminated and adulterated with mercury based thimerosal. It is also alleged that the pt was 1st dx'd and discovered to have mercury poisoning and related severe mental, physical and neurological injuries less than 1 year from 8/21/01. Upon internal review, mercury poisoning with related severe mental, physical and neurological injuries was determined to be an "Other Important Medical Event". No further information is available. Y U 08/20/1992 01/01/2001 3056 OTH OTH UNK WAES01090434 1
0175658 09/25/2001 IL 1.0 U 09/18/2001 Information has been received from a pharmacist concerning a 1 year old pt who was vaccinated with varicella virus vaccine live and the MMR vaccine for treatment of prophylaxis (dose not reported). Five days, post vax, the pt developed a fever and a rash. After 10 day of the fever and rash, the pt was hospitalized. The pt had axillary lymphadenopathy, cracked red lips and the high fever and rash remained. The pt was dx'd with Kawasaki's Syndrome and was treated with IV immune globulin (IVIG). Additional information has been requested. Y U Lab results revealed a platelet level of 700 and an increased erythrocyte sedimentation rate (ESR). UNK UNK UNK WAES01090638 1
0175659 09/25/2001 FL 15.0 13 F 09/18/2001 Information has been received from a physician concerning a 15 year old immunocompromised female pt who is 3 months post-cardiac transplant (5/01). On 8/4/01, the pt was vaccinated with varicella virus vaccine live and hepatitis b vaccine recombinant. Approx. 2 weeks, post vax, the pt developed 150-200 pruritic vesicular and maculopapular lesions and a sore throat. The pt also complained of an abdominal pain that radiated to her back. The pain became excruciating and was localized to the lumbar sacral and lower thoracic region. Initially, the pain was intermittent then it became persistent. It progressed to flank pain. The pt required morphine for back pain relief. She experienced a single episode of vomiting. It was reported that she was negative for cough, diarrhea, headache, joint pain and swelling. Additionally, the physician noted that the pt did not have elevated LFT's to her knowledge, however, at the time of admission her WBC was 10,170 with 82 polys and 12 lymphs. The physician stated that the pt did not have any known exposures to wild type virus. Acyclovir 500mg/day was started on 8/22/01. The pt was admitted to the hospital on 8/22/01 and was discharged on 8/28/01. All symptoms except for a mild sore throat had resolved. The physician felt that her symptoms might be indicative of the viremia she was experiencing. The lesions had scabbed. A lesion sample was obtained for PCR analysis. The pt's discharge dx was disseminated varicella. Additional information has been requested. F/U states that the lesion sample obtained was an inadequate specimen; no strain was identified. Additional info has been requested. F/U states the sample was B-globin neg. Additional follow-up from the physician, received on 10/2/01, indicated that the pt recovered. It was also noted that the pt did not develop herpes zoster, encephalitis, ataxia, meningitis or pneumonia. Additional info is not expected. Y Y 7 Y 08/04/2001 08/18/2001 14 Diagnostic lab on 8/22/01-82 polys; lymphocyte count-12; WBC-10,170; deoxyribonucleic acid-lesion sample for PCR analysis-no strain was identified, it was an inadequate specimen OTH OTH Norvasc, furosemide, CellCept, Mycostatin, "low-dose" prednisone (5mg in AM; 2.5mg in PM), Zantac, Septra, Prograf, vitamins (unspecified); ranitidine hcl (Zantac) Immunosuppression Cardiac transplantation; immunosuppression WAES01090436 1
0175660 09/25/2001 NH 61.0 61 F 09/18/2001 Information has been received from a 61 year old female who on 8/27/01 was vaccinated with pneumococcal vaccine 23 polyvalent. Four to six hours, post vax, the pt's wrist and palm swelled up and became itchy. The pt did not take any medication for 2 days and the swelling spread to feet, thighs and right hand. The pt took diphenhydramine hydrochloride (Benadryl) that day and developed 8" hives in different parts of her body. Five days later, the pt took 4 or 5 days of prednisone. After the 5th day, hives reappeared and her whole face swelled up. Upon internal review, wrist and palm swelling, itching, 8" hives in different parts of her body, reappearance of hives, facial swelling and swelling in feet, thighs and right hand were all determined to be "Other Important Medical Events". Additional information has been requested. F/U has been received from a physician concerning a 61 year old female with asthma, a history of a benign growth on her arm and several episodes of facial swelling and hives with no known cause (unrelated to medications or vaccines) in the 1980's and no known food allergies who on 8/27/01 was vaccinated with a 0.5ml dose of pneumococcal vaccine 23 polyvalent (lot 637262/1068K). Concomitant therapy included fluticasone propionate (Flovent), salmeterol xinafoate (Serevent) and alendronate sodium (Fosamax). Four to six hours, post vax, the pt's left wrist and palm swelled up and became itchy. The pt did not take any medication for 2 days and on 8/29/01, the swelling spread to her feet, thighs, ankles and right hand. The pt took diphenhydramine hydrochloride (Benadryl) that day and on 8/30/01, developed hives on her inner thighs and waist area (trunk). It was noted that the pt was afebrile. Five days later, the pt took a 5-day course of methylrednisolone and 10mg qd cetirizine hydrochloride (Zyrtec). The reporter felt as though there had been probable antigen sensitivity to the recent pneumococcal vaccine 23 polyvalent injection. It was noted that the symptoms resolved, but then on 9/9/01, a single large hive on the right lateral aspect around the axilla appeared. On 9/11/01, sometime in the AM, the pt developed left facial swelling involving her left upper lip and was seen by a physician for a "questionable allergic reaction to pneumovax vaccine" on 8/23/01. It was noted that there was no dyspnea and that the pt was experiencing throat tightness. A physical exam of the pt's skin revealed the following results: "face; no erythema, mild swelling of left upper lip and left face right upper arm, lateral aspect proximal to axilla was well circumscribed erythematous edematous wheal 6-8cm that extended beneath the axilla to the upper right breast". The pt was afebril, had no chlls, weight loss, night sweats, fatigue or lymphadenopathy. Her BP was 120/70. The pt was dx'd with angioedema and urticaria. The pt was administered rofecoxib (Vioxx) 25mg qd and reported that she felt better. It was noted that there was less facial swelling and minimal pruritus. The pt was scheduled to see an allergy fellow and continued the 10mg qd cetirizine hydrochloride (Zyrtec). The pt was also administered fexofenadine (Allegra) 180mg and took the 1st dose in the physician's office. The pt denied recent ASA or NSAID use. It was noted that the subsequent reaction had an "unclear etiology". The reporter felt that urticaria and angioedema were related to therapy with pneumococcal vaccine 23 polyvalent. Upon internal review, angioedema and urticaria were determined to be "Other Important Medical Events". Y U 08/27/2001 08/27/2001 0 BP-120/70; physical exam-see narative OTH OTH Zyrtec, Allegra; Flovent; Serevent; Fosamax Benign neoplasm on arm; several episodes of swelling and hives in th 1980's; asthma WAES01091381 1
0175662 09/25/2001 TN 1.7 1 .7 M 09/13/2001 Pt's mother called on the morning of 9/12/01 and described a warm and swollen left arm. Instructed her to continue with Tylenol every 4 hours and cold compresses until the afternoon then use heat. Mom brought child into clinic on the morning of 9/13/01 with left upper arm swollen, red and slight amount of clear "weeping" from arm. Child appeared fine, otherwise. Instructed use of ibuprofen for anti-inflammatory effect. Admitted to the hospital with cellulitis. Y Y Y 09/11/2001 09/12/2001 1 PUB UNK NONE NONE TN01046 1
0175663 09/25/2001 TX 3.0 1 .0 M 07/25/2001 Lethargy, irritability, loss of words, withdrawal, became more aggressive and sensitive to sounds and people, congestion, etc. Knot at the sit of vaccine. Y Y Y 4 Y N 06/07/1999 Autism - Chat PVT PVT Re-occurring infectious congestion. UNK 1
0175664 09/25/2001 RI 62.0 60 F 09/18/2001 About 1 year, post vax of the 1st dose, the joints in 2 of my fingers became painful and swollen. My back began to pain me. As time went on, several more joints in my other fingers became swollen and painful. I am afraid the skin will break around those joints. My knees are affected but less. I never had anything like this prior to receiving Lymerix and have no family history. Y N 04/02/1999 04/02/2000 366 PVT PVT Premarin, Vitamins, Garlic, Calcium NONE Osteoarthritis 1
0175665 09/25/2001 CA 0.4 0 .3 M 09/17/2001 In 11/97, pt spiked fever and had ear infections every 10 days, following every month, until 8/98. Treated with various antibodies, then had ear infections every 3 months. At 23 months, lost language, had high-pitched screaming, light hurt his eyes, acted like he was deaf and can't stand change. Was dx'd with full blown Autism. Y N 05/28/1997 11/01/1997 157 MIL MIL Harmless heart murmur 1
0175666 09/25/2001 AZ 17.0 17 F 09/18/2001 Approx. 30 minutes, post vax, pt notes swollen eyes and difficulty breathing. The PE noted wheezing throughout lung fields. Rx'd Benadryl 50mg IM X 1, then 25mg; albuterol; Epinephrine 1:1000 0.3ml SC X 1; Solu-Medrol IV; Ranitidine 50mg IV. Y Y 07/07/2001 07/07/2001 0 NONE PUB PUB Usual vitamins, calcium, Clindamycin IV X 24 hours before NONE Allergy to pork, beef, fish, penicillin and nitrofurantoin only. 1
0175668 09/25/2001 MO 0.75 0 .8 F 3 days, post vax, pt developed ischemic left foot. She will eventually lose part of her toes on that foot. Unknown whether this is related to immunizations or not as dx is not yet made. Pt has sickle cell trait. (There is a question as to which thigh received which immunization). Follow up information received 10/10/02 "Can walk now without difficulty, Had to have part of her foot amputated as describe previously,but has recovered from that." The annual follow-up states "can walk now without difficulty. Had to have part of her foot amputated as described previously, but has recovered for that." Y 12 Y N 08/02/2001 08/05/2001 3 Coagulopathy work-up planned in 3-6 months, once pt is off Lovenox. PVT PUB NONE NONE 1
0175669 09/25/2001 WA 1.0 1 .0 F 09/14/2001 This child had prolonged crying 09/13/2001; inconsolable, extensive rash, fever. Y U 09/04/2001 09/13/2001 9 PVT PUB Flouride; now on Motrin. NONE 1
0175670 09/25/2001 CA 0.95 0 1 M 09/28/2001 This infant had a rash on his arms and legs the day after the vaccines. Spread to the trunk and the face. No fever, no vomiting, no joint swelling. Y 09/11/2001 09/12/2001 1 OTH OTH NONE NONE NONE 1
0175671 09/25/2001 KY 1.25 1 .3 F 09/23/2001 No data. Y Y 09/13/2001 09/16/2001 3 PUB PUB NONE NONE NONE 1
0175672 09/25/2001 PA 3.0 3 M 09/20/2001 This child developed erythematous area (5 cm x 7 cm) where injection was given. Afebrile, no pain. Y 09/17/2001 09/18/2001 1 NONE PVT PVT NONE NONE 1
0175673 09/25/2001 AL 2.0 2 .4 F 08/29/2001 A few hours after the patient received Varicella injection the area became half dollar size and hot. She had red raised areas at the side of her face and on leg. Y 08/22/2001 08/22/2001 0 PVT PUB NONE NONE AL0109 1
0175674 09/25/2001 NC 1 .0 M 09/21/2001 5 minutes after administration of MMR, Varivax, and Prevnar # 4, the patient had giant urticaria without wheezing, no angioedema. Resolved approximately 20-30 minutes after administration of Diphenhydramine. Y 09/20/2001 09/20/2001 0 NONE PVT PUB Nasopharyngitis, gastroenteritis. NONE 1
0175675 09/25/2001 CA 0.5 0 .5 M 09/13/2001 Very large induration, on leg that Prevnar was given 3" x $' in size. Bright red and hot to touch, fever of 102 for 1 week and rash resembling chicken pox (but without the pustule) lethargic and arthralgic type pain. Y 04/18/2001 04/18/2001 0 PVT PVT NONE NONE NONE 1
0175676 09/25/2001 CT 1.6 1 .3 F 09/18/2001 This infant developed urticaria approximately 24 hours after vaccines were administered. Y Y 09/01/2001 09/18/2001 17 NONE PVT PUB Erythromycin ophthalmic ointment. NONE NONE 1
0175677 09/25/2001 IL 1.7 1 .7 F 09/11/2001 Had received Varicella and Prevnar, had left the building and came back about 15-20 minutes later and face was bright red with pea sized hives covering her face. Sent to the ER. Y Y 09/10/2001 09/10/2001 0 NONE PUB PUB NONE NONE NONE 1
0175678 09/25/2001 KY 1.08 0 .5 M 09/19/2001 On 9/19/01, mother states that infant had reaction to Pneumococcal vaccine on 2/6/01. Also, had increased heart rate, breathing difficulty and temperature of 103F. She states he was given 2 shots and a breathing treatment. Y Y 02/06/2001 02/06/2001 0 X-ray of lungs PUB PUB Tylenol before immunizations NONE NONE KY2001065 1
0175679 09/25/2001 OH 40.0 40 M 09/09/2001 Received shots at 15:30 and 10 minutes later, became dizzy, diaphoretic and light-headed, color was pale-green. Treated the vasovagal response but didn't improve well so was taken to hospital. Y Y 09/08/2001 09/08/2001 0 MIL MIL NONE NONE NONE 1
0175680 09/25/2001 VA 21.0 F 09/24/2001 One hour, post vax, pt presents with a complaint of tongue swelling and difficulty swallowing. Also had pain with movement. Dx: allergic reaction to Yellow Fever vaccine. Treated with Benadryl 50mg po every 4-6 hours; Prednisone 50mg po X 3 days; Follow-up with doctor if increased SOB. Y U 09/07/2001 09/07/2001 0 MIL MIL NONE Allergy to PCN (causes hive/throat soreness) 1
0175681 09/25/2001 VA 30.0 M 09/24/2001 30 minutes, post vax, pt developed an allergic reaction with generalized pruritus. Treated with Benadryl as prn; no driving; no alcohol use while taking Benadryl and follow-up if symptoms worsen. Y U 09/07/2001 09/07/2001 0 MIL MIL NONE NONE 1
0175682 09/25/2001 VA 25.0 F 30 minutes, post vax, pt has generalized pruritus and complained of nausea. Treated with Benadryl prn; no driving or alcohol while using Benadryl and follow-up if symptoms worsen. Y U 09/07/2001 09/07/2001 0 MIL MIL Possible allergic reactions to PCN; Trilox 1
0175684 09/25/2001 KY 4.0 4 M 08/13/2001 Rash to the left upper thigh, approximately 3 x 3 1/2 in size. Immunization given on 08/01/2001 and the patients mom states rash noted on 08/10/01. No other adverse reactions reported. Y 08/10/2001 08/10/2001 0 NONE PUB OTH NONE NONE NONE KY2001063 1
0175685 09/25/2001 KY 5.0 5 M 08/10/2001 The mother called LCHD reporting as leaving the parking lot. The child started coughing, choking, breathing. Problems and turned pale. Parents rushed the child to the local hospital. Did not come and report to the Health Dept at that time. After treatment and returned home the mother called me. Received steroids and nebulizer treatment at ER. Y Y 08/09/2001 08/09/2001 0 PUB PUB History of asthma. KY2001062 1
0175686 09/25/2001 IN 51.0 51 F 09/20/2001 Knot in injection site, red swelling the size of a silver dollar. The knot has a travel tale moving down the arm. If you touch it, it sends off an itching sensation. Injection was given on 09/18/01 about 10:00 AM. U 09/18/2001 09/20/2001 2 PUB UNK Wood sliver under finger nail. 1
0175687 09/25/2001 MO 30.0 30 F 07/25/2000 Severe joint pain, decreased mobility feet, knees, hands. Prednisone. Approximately 1 month till recovered completely. Y Y 05/11/2000 05/31/2000 20 Lab work - all WNL. Client consulted specialist - diagnosed with serum sickness. PUB PUB BC pill. NONE NONE MO2001050 1
0175688 09/25/2001 NY U Pain, erythema, swelling at the injection site. Y PVT UNK 1
0175689 09/25/2001 CA 72.0 72 F 09/14/2001 Within 2 hours, the pt experienced pain, swelling, redness with rapid extension. Seen in ER and received antibiotics and Benadryl. The symptoms resolved. Y Y 09/07/2001 09/07/2001 0 NONE PVT PVT Prilosec, Premarin, HCTZ, Motrin NONE allergy to PCN, HTN, 1
0175690 09/25/2001 NV 48.0 47 F 09/17/2001 The pt received 2nd dose of MMR on 8/23, 7 days later the pt developed rash on chest, arms, legs and face. The pt also complained of severe itching, raised papules that open and drain purulent drainage. The pt also complained that this also happened on the 1st dose. Y U 08/23/2001 08/30/2001 7 NONE PUB PVT Benadryl NONE NONE 1
0175691 09/25/2001 CA 12.0 12 F 09/17/2001 According to the MD, the pt complained of fatigue, chills, some liver tenderness and was going to be check for mononucleosis, liver enzymes. Symptoms started 1 day post vax. The pt's mother states that she had a reaction to the first injection but did not report it. Y U 09/12/2001 09/13/2001 1 Mono test, liver enzymes OTH OTH NONE NONE fatigue, fever~Hep B (no brand name)~1~11.00~In Patient 1
0175692 09/25/2001 WA 1.4 1 .6 F 09/17/2001 The pt experienced a fever which began one day post vax, and continued through the next day. The pt experienced pinkness with swelling to the right thigh. Treated with Zyrtec and Elacon cream. Advised not to have the pertussis vaccine in the future. Y Y 09/12/2001 09/13/2001 1 PVT PUB slight nasal congestion allergic rhinitis 1
0175693 09/25/2001 RI 4.0 4 F 09/13/2001 The pt experienced a large local reaction. U 09/11/2001 09/13/2001 2 UNK UNK NONE 1
0175694 09/25/2001 IN 1.25 1 .0 M 09/13/2001 On 6/6/01 the pt was seen in the ER for having a seizure at home that lasted approximately 60 seconds and then went limp. The pt was noted to have a gaze and muscle stiffness. The pt is now on Tegretol. Y Y 05/29/2001 06/06/2001 8 EEG PVT UNK 1
0175695 09/25/2001 OH 4.0 4 F 09/21/2001 The pt experienced focal urticaria versus fixed drug eruption over the injection site, right thigh lasting weeks. One month later, recurrent small area of urticaria. Y 08/08/2001 08/09/2001 1 PVT PVT NONE NONE NONE 1
0175696 09/25/2001 CA 4.0 4 M 09/11/2001 Allergic reaction within 4 hours of administration of vaccine. External ears red and swollen, welts, no itching, wheals on buttocks, abdomen and legs. Y Y 09/11/2001 09/11/2001 0 NONE PVT PUB NONE NONE NONE 1
0175697 09/25/2001 MD 1.0 1 .0 M 09/19/2001 Pt's temperature was 103F and was not acting normal. He had vesicular-type lesions over face and extremities. (Rash onset 9/5/01) (temperature onset 9/6/01). Y Y 08/27/2001 08/27/2001 0 NONE PVT PVT NONE NONE NONE MD01006 1
0175698 09/25/2001 FL 0.8 0 .4 M 09/21/2001 Rash and face was swollen and covered entire body. Went to ER and was given SC Epinephrine and Oral Benadryl and Prednisolone. Y Y 04/23/2001 04/23/2001 0 NONE PVT PUB NONE NONE NONE 1
0175699 09/25/2001 WA 1.25 1 .3 F 09/20/2001 Pt had a diffuse maculopapular rash, starting in extremities and moving centrally with a low-grade temperature. No oral lesions, conjunctivitis or nasal discharge. Pt was seen on 9/18/01. Her brother got an MMR on the same date. (I also saw another 2 kids with exactly the same rash, 2 days after their immunizations). Y U 09/11/2001 09/17/2001 6 OTH OTH NONE ~Measles + Mumps + Rubella (no brand name)~~0.00~In Sibling 1
0175700 09/25/2001 CA 0.2 0 .2 M 09/17/2001 The pt broke out in a rash over trunk with a temp of 101. Was seen in ER with no findings. Y Y 09/06/2001 09/06/2001 0 NONE OTH PUB NONE NONE hx of c-section, breach / twins CA010100 1
0175701 09/25/2001 IL 26.0 26 U The pt experienced tiredness, nausea, vomiting, restlessness, hacking cough the same evening of the vax. The next day he started having migraine headaches. Y Y 08/21/2001 08/21/2001 0 PUB UNK NONE NONE 1
0175702 09/25/2001 MI 4.0 4 F 09/18/2001 Mother states a child experiencing "continued rash". Since receiving vaccines. The pt was seen by private physician and diagnosed with shingles. Y U 06/07/2001 culture - pos` PUB PUB NONE NONE NONE 1
0175703 09/25/2001 FL 1.08 1 .1 M 09/17/2001 The pt experienced a rash on the abdomen and was diagnosed with roseola. Rash appeared over entire body. U 09/05/2001 09/17/2001 12 PUB PUB 1
0175704 09/25/2001 MI 0.3 4 F 09/18/2001 24 hours post vax the pt had a fever of 103, vomiting, the next day was ok. 5-7 days later got hives no other symptoms. Approximately 2-3 weeks later has round , red, slight raised rash, scattered on torso, backs of legs, which are occasionally itchy. The pt was seen by a physician. Y U 07/30/2001 07/31/2001 1 PUB PUB NONE NONE NONE 1
0175705 09/25/2001 NJ 74.0 74 M 09/19/2001 The pt experienced vertigo, fever and malaise. Y N 09/10/2001 09/13/2001 3 PVT PVT NONE 1
0175706 09/25/2001 OH 4.0 4 F 09/19/2001 On 9/7/01 between 1:15 to 1:30, patient was observed having grand mal seizure after getting off the tricycle at preschool. Patient does not remember getting off tricycle and starting to walk. She fell foward, hitting her forehead as a result of the seizure. Y Y 08/28/2001 09/07/2001 10 Had blood work, MRI and urine sample is being tested for a possible genetic problem. PUB PUB NONE NONE Familial hand tremor. OH0051 1
0175707 09/25/2001 KY 1.0 1 .1 F 09/16/2001 The mother of the pt states that she related of symptoms in both legs, back and neck. Wyeth doctor ordered lab work. Areas of petichiae in lateral and posterior arm. The pt is now improving with the left leg appearing to be gone. All lab work was normal. Y 09/13/2001 09/14/2001 1 CBC, PTT, PT PVT PVT NONE NONE NONE KY2001091 1
0175708 09/25/2001 KY 6.0 5 F 09/07/2001 The pt experienced vesicular lesions, no medications were ordered. The Varicella ran normal time course. Y Y 08/24/2001 09/06/2001 13 PUB PUB NONE NONE NONE KY2001060 1
0175709 09/25/2001 TX 10.0 10 F 09/24/2001 The pt experienced a temp of 104 lasting 3 days, fatigue, disorientation, reddened eye. Treated with tobrimyacin. Y Y 08/13/2001 08/20/2001 7 PVT PVT NONE NONE congenital ureter malformation ~Hep B (no brand name)~1~0.90~In Sibling 1
0175710 09/25/2001 TX 1.08 0 1 M 09/21/2001 The pt states 1 week post vax, the pt broke out in blisters and then scabs that covered blisters. U 09/05/2001 09/12/2001 7 PVT OTH PPD / C0045AA NONE NONE 1
0175711 09/25/2001 TX U The pt experienced blisters all over body, very painful. Doctor confirmed varicella. Y U 12/16/1998 09/20/2001 1009 PVT OTH NONE NONE NONE 1
0175712 09/26/2001 TX 1.08 1 .1 F 09/24/2001 The parent reported some fever the evening of the vaccine. Normal day of 09/21/01. The family put the child down to bed, no symptoms 09/21/01 at 8:00 pm. Family checked at 9 pm, the child's color was white, unresponsive. Rushed to the hospital, the child arrested. Autopsy findings for cause of death were bronchopneumonia, laryngitis, cerebral edema. Y 09/21/2001 N 09/20/2001 09/21/2001 1 PUB PUB HEP-A IG/lot ISG136/IM/RL/0 previously NONE UNK TX01130 1
0175723 09/26/2001 ND 1.7 1 .6 F 08/31/2001 9 days after vaccination she began vomiting immediately after she ate or drank. 11 days after vaccination she began having seizures, (no temperature), and was hospitalized and put on phenobarbital which she is currently taking. She was hospitalized for testing for 3 days. Follow up information received states "long term effects are unknown at this times." The annual follow-up states "long term effects are unknown at this time." Y Y 3 U 08/07/2001 08/18/2001 11 PUB PUB NONE NONE 1
0175724 09/26/2001 NV 57.0 57 F 09/20/2001 On 9/3/01, PM, pt had cloudy vision on the left and sharp left frontal headache X 2 for 20 seconds while shopping at the mall. No associated dizziness, nausea or other symptoms. No stress, trauma, toilet straining or toxins. On 9/4/01, seen by ophthalmologist. On 9/5/01, had transient loss of some vision for about 1 hour in the right eye and ++ tender right calf for about 1 hour. Pulses and color normal. Sensory (fifth) left loss for +24 hours. Fields by confrontation and pin confirmed. On 9/6/01, seen by Retinologist and floursecein angiography was ok. Neurologist fifth confirmed. MRI was read as normal by neuro-radiologist. On 9/7/01, Neuro-retinologist was seen. On 9/10/01, conferred with immunologist, rheumatologist. On 9/14/01, had mammogram. Took aspirin (just because) without symptoms. On 9/17/01, had good neuro exam by chiropractic neurologist. No Dx or RX. On 9/18/01, was given Diamox 500 SR bid for 1 day and then Diamox qd since light-headed. On 9/24/01, had Retinologist follow-up. On 9/26, LP was normal. Also had special tests. Field defect and subjective complaints which vary slightly. For instance, defect became worse after she sneezed and vision maybe "slightly better after chiropractic visit". Thus far, all studies of blood, MRI, optic nerve conduction, flourescein angiography has been normal. Audiogram and acoustic reflex (unilateral only) was normal. No associated symptoms at all. No internist has ever seen her. No complete physical has ever done. No spinal tap, ultrasound of vessels or other studies have been done. ASA discontinued on 9/18/01. Note: Severe 1st time allergic reaction to shitoke mushrooms, 6 weeks ago. No cross reaginicity or long term problems found in literature search. Hep-B #1 injection +3 weeks ago, without local reaction. Reports of association with optic neuropathy, etc, denied by immunologist. Uneventful trip to Canada (Lyme) 5 weeks ago and Cedar City about 3 weeks ago. Blood test negative. No clinical history. Dx: blind in left eye (quadrant defect) and bilateral optic nerve neuropathy; no etiology. Follow up information received 10/18/02 stated, "blindness Partial, Cognitive Problems" Y Y Y N 08/15/2001 09/03/2001 19 Visual tests; MRI; Neurological tests; Mammogram; LP; Blood tests-all WNL PUB UNK NONE NONE NKA 1
0175725 09/26/2001 TX 0.4 0 .4 F 07/11/2001 Pt received 4 month immunizations with Prevnar, HIB, DTAP and IPV and 24 hours later, was admitted to PICU for respiratory failure. Still in ICU on 9/25/01. Y Y 18 N 07/09/2001 07/10/2001 1 LP; MRI of Brain PVT UNK Poly-Vi-Sol NONE Preterm delivery 1
0175726 09/26/2001 KY 4.0 4 M 09/19/2001 Pt's left arm was severely swollen from elbow to shoulder with redness in this entire area. Y 3 Y 08/29/2001 08/31/2001 2 PVT PUB NONE NONE 1
0175727 09/26/2001 NY 4.0 4 M 02/08/2001 U 02/06/2001 02/07/2001 1 PVT OTH PPD/Aventis/C0256AA/LFA 1
0175728 09/26/2001 MI 0.3 0 .3 F 09/20/2001 Within minutes, post vax, child developed 5 spots that became larger while mom and nurse observed on pt's calf area. Child rushed to MD's office within 5 minutes. Benadryl was given. Y Y 09/12/2001 09/12/2001 0 NONE PUB PUB NONE NONE NONE 1
0175729 09/26/2001 MA 1.25 1 .3 F 08/21/2001 On 10/20/00, pt developed hives and mother gave Benadryl and reported by phone that it had resolved. Y 10/18/2000 10/20/2000 2 PVT PUB Amoxil 125 on 10/11/00 NONE Asthma; Eczema; Allergy to Sulfa 1
0175730 09/26/2001 PA 4.0 4 M 09/17/2001 Pt developed swelling and redness at the site of injection in left thigh (was treated with ibuprofen) for low-grade fever, 24 hours, post vax. Y 09/15/2001 NONE PUB PUB NONE NONE NONE 1
0175731 09/26/2001 NC F The day of injection, within a few hours, pt became very irritable and had rapid jerking motions of her extremities. Y 08/15/2001 08/15/2001 0 EEG-nml PVT PUB NONE NONE Prematurity, Hydrocephalus; Development Delay 1
0175732 09/26/2001 MA 0.75 F 09/14/2001 Baby developed a rash over entire body and went to ER. Dx wasn't sure if viral infection or adverse reaction to vaccine (Prevnar). Y NONE PVT PUB NONE 1
0175733 09/26/2001 TN 1.5 2 .5 F 09/20/2001 Pt's left thigh swollen and warm. No blisters or joint swelling. U 09/18/2001 09/18/2001 0 PVT PUB NONE NONE 1
0175734 09/26/2001 NH 1.08 0 .8 M 09/25/2001 Pt developed a temperature of 105F, reported by mom. Did not call healthcare provider and was not seen by physician. Seen by physician on 5/15/01 for high fever, cold and ear pain. Physician's note red "since 4/20/01 treated with 3 different antibiotics with no effective relief. Still crying a lot." Y 04/26/2001 04/26/2001 0 NONE PVT PUB Augmentin bid X 10 day Bronchitis and persistent otitis media NONE NH0121 1
0175735 09/26/2001 NE 15.0 15 M 09/10/2001 On 9/10/01, LPN phoned at 13:45 stating that the pt had developed a temperature, achiness and sensitivity to light, post vax. Phoning the mother at 14:00, she stated that he no longer had a fever but was achy and sensitive to light. On 9/11/01, mother phoned this office and spoke with the Director, RN, and stated that the pt went to school and is no longer ill. Y 09/07/2001 09/10/2001 3 PUB PUB NONE NONE 1
0175736 09/26/2001 VA 5.0 M 09/11/2001 A 5 year old well child received routine IPV and DTAP on right upper arm on 9/6/01. On 9/7/01 evening, mother noted hot violaceous, edematous reaction from right shoulder to elbow. Pt had no fever. He received Augmentin for probable cellulitis with improvement. Y 09/06/2001 09/07/2001 1 UNK UNK NONE NONE 1
0175737 09/26/2001 CT 0.3 0 .3 F 08/27/2001 Pruritus and rash; onset the day after administration and was treated with prelone syrup. Y 12/08/2000 12/09/2000 1 PVT PUB NONE NONE CT200107 1
0175738 09/26/2001 PA 43.0 43 M 09/24/2001 Pt began experiencing dizziness within 24 hours, post vax. Pt had flu-like symptoms to include productive cough of green sputum and nasal drainage and severe weakness. Over the next 4 days, he began to develop flu-like symptoms including fever, diaphoresis, a pounding headache in the back of his head, a ringing in the right ear and generalized weakness and tinnitus. He does experience occasional blurred vision and has had a decrease in appetite. Following the removal of the cerumen impaction of the right ear, the pt began to feel some relief of his dizziness and complete relief of his headache. He does continue to experience a productive cough and nasal drainage. He was advised that these symptoms would resolve as his bronchitis resolves. He continues to take the Zithromax and Duratuss. He was also advised that if these symptoms do not resolve, to contact the VHC for further evaluation. The pt has completed his required immunizations against polio. There is not a strong enough association between his symptoms and IPV to prohibit him from receiving future vaccinations. It is safe for him to receive other immunizations such as influenza and TD. VHC will contact him in a few days to follow-up on his symptoms. Add 3 more days of Duratuss (total 6 tablets) for cough; begin nasal saline spray (2 sprays each nostril QID to help with nasal drainage) and begin Afrin nasal spray (2 sprays each nostril TID to help with nasal drainage). On 9/19/01, repeat tilt test was positive, therefore 1 liter of NS was given IV. Continue to hydrate orally. Y N 09/09/2001 09/09/2001 0 CXR; lab work; ECG-all neg;Baseline PFT; Tilt test (lying, sitting and standing for 30 minutes)-pos; Sed Rate-19 (elevated) 22 on 9/18/01; Audiometric test show SNHL, recommend pt to see civilian ENT service at home. MIL MIL Zithromax (Z-pack) started on 9/14/01 and Guaifanex PSE 120 (Duratuss) BID X 5 days, started on 9/14/01; Motrin for fever and headache NONE L1-S5 back surgery in 2000 1
0175739 09/26/2001 MN 51.0 50 M 09/19/2001 Pt developed very sore, swollen and hot joints after Lymerix vaccination. I couldn't walk for quite some time. (Pt had 3 Lymerix injections over a 1 year period). U 10/15/1999 10/16/1999 1 PVT PVT NONE NONE 1
0175740 09/26/2001 CA 0.75 0 .3 F 09/14/2001 The pt experienced a atrophic scar of right deltoid about 4 cm in diameter. N 03/23/2001 PVT OTH NONE NONE 1
0175741 09/26/2001 MA 58.0 58 F 09/21/2001 The pt experienced swelling of the left arm from the shoulder to elbow, with redness, hot to the touch, tenderness and unknown if pt had a fever. Y 09/06/2001 09/07/2001 1 PUB PUB Verapamil, Premarin, dicyclomine, Lasix, Lipitor, ASA and vitamins NONE hypertension, high cholesterol 1
0175742 09/26/2001 MN 5.0 5 F 09/17/2001 The pt experienced swelling and redness, some itching and not much pain to the injection site. Saw MD and was considered a severe reaction. Treated with Benadryl and Prednisone, epinephrine. Y Y 09/12/2001 09/13/2001 1 PUB PUB NONE NONE NONE 1
0175743 09/26/2001 MI 4.0 4 M 09/21/2001 The pt experienced a 7 1/2 cm circle of induration with extended region of erythema past that. The pt also experienced itching and pain to the right deltoid region. Y U 09/19/2001 09/19/2001 0 NONE PVT PVT NONE NONE allergy to penicillin / hives 1
0175744 09/26/2001 VA 11.0 11 F 09/21/2001 The pt experienced a fever, was lethargic, experienced vomiting and then recovered over a 4 day period beginning the day of the vax. Y 09/17/2001 09/17/2001 0 NONE PUB PUB NONE NONE anemia 1
0175745 09/26/2001 GA 37.0 36 M 09/07/2001 The pt experienced a fever of 101, chills, night sweats, headache occurring 2 days post vax. Follow up on 12/11/2001: "Please not vaccination administered at different location." Y Y 07/09/2001 07/31/2001 22 urinalysis, urine culture MIL MIL Coumaden NONE NONE 1
0175746 09/26/2001 NC 10.0 25 M 09/06/2001 The pt had a sudden onset of diaphoresis, dizziness, nausea and a hissing noise in his head. The pt complained of intermittent symptoms since. Y N 06/28/2001 06/29/2001 1 UNK UNK NONE NONE 1
0175747 09/26/2001 OR 1.0 0 .0 F 09/18/2001 Pt developed a small, red, blotchy rash on her face and a 1cm to 2cm local reaction at the injection site (LL). Y 09/18/2001 09/18/2001 0 PVT PVT NONE 1
0175748 09/26/2001 FL 58.0 58 F 09/18/2001 Extreme muscle pain started in neck and back by late Wednesday Evening. The pt could hardly lift arms over head. The pt experienced hip and buttock pain and then the legs were affected. Y 08/27/2001 08/29/2001 2 PUB OTH Ziac diet controlled diabetes, HBP 1
0175749 09/26/2001 CA 29.0 29 M 09/18/2001 The symptoms started on the day following the vax and persisted for two days. Abdominal cramping, loss of appetite, low grade fever of 99-100 degrees, aching joints, tiredness, soreness of injection site. Symptoms began 3 hours post vax. Y 06/15/2001 06/16/2001 1 PUB PVT NONE NOEN 1
0175750 09/26/2001 IN 10.0 5 F 09/19/2001 Pt had varicella vaccine on 8/12/96 and developed clinical varicella on 9/11/01. This is not an adverse event but a vaccine failure. Y 08/12/1996 09/11/2001 1856 PVT PVT NONE NONE 1
0175752 09/26/2001 KY 1.25 1 .3 M 09/19/2001 Pt developed redness on right leg about 3" to 4" around the injection site. Y Y 09/05/2001 09/07/2001 2 PVT PVT NONE 1
0175753 09/26/2001 KS 4.0 1 .1 M 09/20/2001 On 9/17/01, complained of burning in left leg. On 9/18/01, awoke with eruption. On 9/20/01, rash was seen and evaluated. Eruption in dermatome pattern. In treatment and anticipate recovery. U 03/04/1998 09/17/2001 1293 NONE PUB PUB NONE Zoster NONE 1
0175754 09/26/2001 MD 4.0 4 M 04/10/2001 Pt started with pox of scalp, then to back, arms and legs about 7-10 a day. Y 09/10/1998 12/18/2000 830 PVT UNK NONE NONE 1
0175763 09/27/2001 PA 21.0 21 F 11/01/2001 A 21 year old black female with urinary tract infections, a history of possible migraines and a history of 2 pregnancies and 2 live births who in 08/00, was vaccinated with varicella virus vaccine live. Subsequently, the patient learned she was pregnant with a last menstrual period of 06/23/00, and an estimated delivery date of 03/13/01. On 12/15/00, an ultrasound revealed an anatomy within normal limits. Subsequently, the patient experienced complex partial seizures, vaginal candidiasis, trichomoniasis, bacterial vaginosis and possible migraines. On 03/16/01, the patient delivered a normal male baby weighing 3656 grams. Upon internal review, complex partial seizures was determined to be an Other Medical Event. F/U states: Subsequently, the pt learned she was pregnant with a last menstrual period of 6/23/00 and an estimated delivery date of 3/14/01. It was noted that the pt conceived while on oral contraceptives. It was noted that the pt saw neurology during pregnancy and was dx'd with complex partial seizures with secondary generalization. It was also noted that during pregnancy, the pt was dx'd with trichomoniasis, bacterial vaginosis and vaginal candidiasis. Treatment for these dx's included metronidazole (500mg PO on 12/14/01 for trichomoniasis), metronidazole (500mg 1 PO for 7 days starting 2/6/01 for bacterial vaginosis) and metronidazole (12/14/01 for 7 days for vaginal candidiasis). As of 12/14/01, the pt was taking prenatal vitamins. On 3/16/01, the pt delivered a normal, healthy male baby weighing 3656 grams, measuring 47.5cm long and having a head circumference of 37cm. He was delivered using vacuum extraction and had Apgars of 8 and 9 at 1 and 5 minutes respectively. It was noted that the child had macrocephaly. A head ultrasound was done and was normal. There were no observed abnormalities at the newborn exam or at discharge. Circumcision was done with no complications. Screening tests were all done and were normal except a hemoglobinopathy showed "FA + Hemoglobin Barts (trait)". Upon internal review, complex partial seizures with secondary generalization was determined to be an "Other Important Medical Event". U 08/01/2000 12/14/2000 135 On 12/15/00, an ultrasound revealed an anatomy within normal limits. Screening tests were all done and were normal except a hemoglobinopathy showed "FA + Hemoglobin Barts (trait)". UNK UNK Excedrin Migraine, Antimicrobial (unspecified), Clotrimazole, hormonal contraceptives, Ibuprofen, Metronidazole, Prenatal Vitamins (unspecified). Migraine. Pregnancy (LMP= 06/23/00), urinary tract infection. WAES01010565 1
0175768 09/27/2001 CA 50.0 50 F 07/21/2001 Pt's left arm was sore and with a walnut-sized lump X 10-13 days and disappeared. Pt had a rash on body, sores in mouth, joint and muscle pain. She was seen at Urgent Care X 2 then saw a dermatologist X 3 months. Vasculitis due to influenza was medical Dx. Pt's left and right ankles were tender, scarred and stinging. Buspar was taken. Y Y Y N 11/01/2000 11/02/2000 1 CBC; U/A; Sigmoidoscopy; Kidney Scan PVT UNK Levothyroxine NONE NONE 1
0175769 09/27/2001 TX 0.25 0 .3 F Day 1, 09/17/01, at approximately 11:40 spiked fever of 102 - 103 at 1 pm a little fussy, decreased appetite; sites fine. Day 2, 09/18/01 - Still temp 102 - 103 for 24 hours fussy, decreased appetite. Day 3, 09/19/01, temp 102 - 103, crying non-stop, Not eating, not sleeping. Admitted to the hospital for a septic work-up. Labs normal. Crying ceased 09/20/01. Fever ceased 09/19/01 in the AM. Appetite returned 09/21/01. Discharged on 09/21/01 at 8 am. Discharge Summary Diagnosis is Fever resolved, irritability resolved, above most likely due to immunization reaction. Y 3 Y 09/17/2001 09/17/2001 0 Labs drawn for septic work-up - all normal. PVT PUB NONE NONE NONE 1
0175770 09/27/2001 FL 2.0 2 .0 F 09/25/2001 Pt complained of 101.5F fever yesterday (9/20/01), half dollar-sized at localized area almost a golf ball-sized reaction per mom. Pt had redness and swelling, painful area, and was tired and quiet. Y Y 09/19/2001 09/20/2001 1 NONE PVT OTH NONE NONE Poor weight gain about 2 years. 1
0175771 09/27/2001 MA 56.0 56 F 09/18/2001 Pt received vaccines on 8/10/01 and 8/16/01. On 8/24/01, the pt stated she had experienced a 30 second LOC with "shaking leg and "gurgling" as described by her husband, who witnessed the event. This was preceded only by "extreme fatigue", which the pt said lasted for 1 hour, before event. She had no headache or dizziness or other signs or symptoms and stated she felt "terrific" after the event. She did not seek medical attention elsewhere. (Pt alerted me on 9/18/01 of the event which occurred on 8/24/01). Y 08/16/2001 08/24/2001 8 PVT PVT Vitamins NONE 1
0175772 09/27/2001 IA 72.0 72 M 07/19/2001 Pt's right arm with swelling and pain, less than 24 hours, post vax. No fever or rash. Treated with Benadryl and ice prescribed. U 09/17/2001 09/18/2001 1 PUB PVT NONE Lower extremity varices 1
0175773 09/27/2001 CO 39.0 39 M 09/24/2001 Pt's "windpipe" swelled, 2 days post vax. He went to ER and received Benadryl and epinephrine. Pt had dizziness and pulse OX was 85%. Repeat pulse OX was 92% on room air. Swelling reoccurred the next morning. Pt administered more epinephrine. Y Y 08/27/2001 08/29/2001 2 PUB PUB Valium per ER report NONE History of migraines 1
0175774 09/27/2001 ME 13.0 14 M 09/21/2001 Pt's mother contacted office stating that the site is bright red, warm and raised. It is also, very tender. U 09/19/2001 09/20/2001 1 NONE PVT PUB NONE ME01035 1
0175775 09/27/2001 ME 8.0 3 F 09/29/2001 Pt developed a rash; onset 3 days ago. Also had malaise and headache. Seen on 9/23/01 and had 5 vesicles and 20 spots. U 03/10/1997 09/21/2001 1656 NONE PVT PUB NONE ME01036 1
0175776 09/27/2001 ME 7.0 1 .5 M 09/24/2001 Pt developed a fever and rash on 9/21/01. He was seen on 9/23/01 with over 30 spots and some vesicles. U 09/15/1995 09/21/2001 2198 NONE PVT UNK NONE ME01039 1
0175777 09/27/2001 PA 18.0 18 F 09/05/2001 On 8/10/01 at 19:00, pt vomited until 8/11/01 in the AM and then she had an onset of a headache, nausea, fever and fatigue. Symptoms continued on an intermittent basis. On 8/23/01, pt seen by PMD and put on Inderal and Vioxx for 1 month. Pt is to see PMD on 9/7/01 for evaluation. On 9/5/01, mother reports that headaches continue. Other symptoms have resolved. Y Y 08/10/2001 08/10/2001 0 NONE PUB PUB History of migraine headaches since the age of 13. PA0155 1
0175778 09/27/2001 MD 15.0 14 F 09/20/2001 Rabavert given on 9/14/01. Telephone call on 9/17/01, reporting itching and rash. Pt seen on 9/17/01. Rash was over face and neck and itching had started on 9/16/01. No difficulty in swallowing or breathing. Left eye swollen. Medrol dose-pack ordered and Benadryl cream for itching. Y Y 09/14/2001 09/16/2001 2 NONE PUB PUB NONE NONE NONE 1
0175779 09/27/2001 CA 4.0 4 U The pt experienced right upper arm erythema that was 5 x 6 inches in size. Y 09/19/2001 09/21/2001 2 PVT UNK PPD / Connaught / CO630AA / RFA 1
0175780 09/27/2001 NH 10.0 9 F 09/24/2001 The pt experienced a painful rash on left side of face. A cluster of vesicles just in front of ear with a few vesicles scattered. Diagnosed with Shingles. Y 05/24/2001 09/17/2001 116 PUB UNK 1
0175781 09/27/2001 MO 13.0 13 F 09/17/2001 A short time after leaving the health center, the pt became ill, complained of nausea with a headache. She complained of a sever headache all night, experienced nausea and vomiting, called ER in the night was told to give Tylenol. Mother called the health center to report symptoms. Y U 09/06/2001 09/06/2001 0 PUB OTH UNK NONE asthma MO2001051 1
0175782 09/27/2001 AR 1.08 1 .0 M 09/25/2001 The pt developed a fever of 101; 24 hours post vax. The pt broke out in a rash 10 days post vax. The rash was raised and itchy. Y U 09/14/2001 09/24/2001 10 PUB OTH cold NONE 1
0175783 09/27/2001 OR 4.0 4 M 09/20/2001 Pain and swelling of elbow on the same arm as the shot was given. Started 3 weeks, post vax, and lasted about 1 week. Y Y 07/12/2001 08/08/2001 27 CBC; ESR; Blood cultures-neg; X-ray showing mild joint effusion PVT PVT Mild URI NONE 1
0175784 09/27/2001 MA 12.0 11 M 09/24/2001 Pt developed a temperature of 103F within 24 hours, post vax. No other symptoms developed. Resolved within 24 hours. Y 10/02/2000 10/03/2000 1 NONE PVT PUB Albuterol; Flovent NONE Asthma 1
0175788 09/28/2001 MS 0.2 0 .2 F 09/27/2001 24 hours, post vax, pt had a seizure with subsequent seizures on the following 2 days; described as tonic/clonic. Pt was taken to local ER when phenobarbital was given. Y Y 2 U 09/22/2001 09/23/2001 1 EEG-nml; CT Scan-neg; CSF culture-neg; Blood culture-neg PUB PUB NONE NONE 1
0175789 09/28/2001 CA 1.0 1 .0 M 09/16/2001 Pt developed fever, spiking onset, 7 days, post vax. He had urticaria, 8 days, post vax, with irritability, 7 days, post vax. Pt also had the 4th Prevnar vaccination on 9/10/01. Y Y Y 09/07/2001 09/14/2001 7 NONE PVT PVT NONE NONE 1
0175790 09/28/2001 NY 0.3 0 .3 M 09/18/2001 6 days, post vax, pt had 2 similar 'grand mal' seizures. Over the course of 6-8 months, he lost speech and became unrelated. Now has been dx'd with PDD/ASD. Y Y 1 Y N 05/22/1999 05/28/1999 6 MRI and EEG-showed no problems; Spinal Tap; Blood work; Urinalysis; 24 hr EEG; Fragile X test PVT OTH NONE NONE NONE 1
0175791 09/28/2001 NV 21.0 21 M 08/21/2001 Total disability due to demyelination following reaction to tetanus toxoid injection in the US Army. Y Y Y N 01/01/1944 MIL MIL 1
0175792 09/28/2001 MN 39.0 39 M 09/21/2001 This 39 year old pt who 3 days prior to admission had 3 vaccines and shortly thereafter, he had a headache. The headache persisted until the day of admission. On the evening prior to admission, he noticed the insidious onset of left-sided weakness involving his upper and lower extremity as well as difficulty swallowing and a left facial droop. He was treated empirically for an acute CVA based on his symptoms, but after discussing the case at length with neurology, we decided to stop his heparin and treat him for an allergic response to his vaccines. He was started on prednisone and will be discharged on a Medrol Dosepak. He had improvement, albeit minimal, with regard to his presenting symptoms. I have recommended that he not travel for 2 weeks and that he follow-up with a neurologist in 4 weeks. Discharge medications besides Medrol Dosepak include Enteric-coated aspirin 81mg #1 po qd and Synthroid 0.12mg po qd. Y Y Y 09/07/2001 09/09/2001 2 Cat Scan and MRI-unremarkable; LP-unremarkable but there are still results pending including electrophoresis and myelin basic protein PVT PVT NONE Allergy to iodine (anaphylactoid reaction) 1
0175793 09/28/2001 TX 12.0 12 F 10/04/2001 She had chills and started with 2 bumps on face and then a high fever of 104F for 2 weeks. She had 2 spots on her body. She started to have a nonproductive cough and was not sleeping well. Then was put in the hospital, given IV fluid hydration secondary to poor oral intake and the doctor did all kinds of test and then I was told it was an allergic reaction to Hep-B shot and was given Tylenol and Advil every 3 hours (alternately). Not completely recovered yet. Had erythema nodosum caused by the fever of 104F. She also had shoddy adenopathy of less than .5cm in size to 3.5cm in size. These are palpable subcutaneous appearing nodules. She had also been pale and lethargic before hospitalization. Per doc 205739, still has not been dismissed. Y Y Y 4 U 06/29/2001 06/30/2001 1 ANA-neg; WBC-7,900 (low); Hemoglobin-9.1 (low); hematocrit-26.8 (low); Platelets-267,000; Neutrophils-73, lymphs-15; monos-10; glucose is 99; BUN-5; creatinine-.5; Sodium-141; Potassium-4.1; chloride-105; C02-23.8; Mono test-neg; X-rays-nml. On 7/26/01, her Sed Rate was elevated. PUB PUB Biaxin which was started on 7/27/01; ibuprofen and Tylenol NONE History of multiple URTI, undergoing adenoidectomy, tonsillectomy and bilateral ear tube placements with hearing loss of 40%, due to multiple otitis episodes; also, she has a history of multiple episodes of bronchitis. 1
0175794 09/28/2001 OH 0.5 F 09/21/2001 Within a couple of minutes, post vax, the pt broke out with generalized red, flat blotches all over her body and was fussy. Benadryl was given. Y 07/25/2001 07/25/2001 0 PVT OTH 1
0175795 09/28/2001 OH 0.5 M 09/21/2001 Within a couple of minutes, post vax, the pt broke out with generalized red, flat blotches all over his body and was fussy. Benadryl was given. Y 07/25/2001 07/25/2001 0 PVT UNK 1
0175796 09/28/2001 VA 1.2 1 .2 F 09/21/2001 Vasovagal response; pale and limp, post vax. Tactile stimulation and ice to baby's feet and has responded to stimulation. Y 09/21/2001 09/21/2001 0 MIL MIL NONE NONE 1
0175797 09/28/2001 CA 0.3 0 .0 M 09/27/2001 The next day, post vax, the pt began vomiting after eating. Around mid-afternoon on 5/26/01, he also had a low-grade fever of 100F. Symptoms subsided the next day, on 5/27/01. Y 05/25/2001 05/26/2001 1 NONE PUB PUB NONE NONE 1
0175798 09/28/2001 VA 10.0 10 M 09/18/2001 Post vax, at 13:20, the pt's class went outside to run on track. Afterwards, he became diaphoretic, had increased heart rate (136); audible wheezing; hoarseness; rapid breathing and chest pains. Lungs were clear despite audible wheeze. He drank coke and blew into a paper bag. His heart rate eventually came down to 128, 104 and then to 82 after 20 minutes. Y 09/17/2001 09/17/2001 0 OTH PUB NONE NONE NONE 1
0175799 09/28/2001 NM 4.0 4 F 09/14/2001 The pt experienced redness, swelling and pain at the site of DTAP injection on the left deltoid. Resolved with Benadryl and Advil. Y Y 09/06/2001 09/07/2001 1 NONE PVT PUB NONE right cheek and chin has erythema papules NONE 1
0175800 09/28/2001 MI 3.0 3 M 09/24/2001 Same day following vax, the pt napped then had lunch and then napped again at the daycare. Later that afternoon, the pt experienced a seizure. An ambulance was called and the pt experienced a temp of 104. The pt was taken to the ER and was treated with Tylenol and the temperature reduced. The child was sent home 6 hours later. Y Y 09/06/2001 09/06/2001 0 CAT scan, blood work PUB PUB NONE NONE hx of seizures since 6 months old. 1
0175801 09/28/2001 OH 5.0 5 F Pt developed a fever, nausea and vomiting and fatigue. U 09/17/2001 09/18/2001 1 NONE PUB PUB NONE 1
0175802 09/28/2001 OR 17.0 13 F 09/21/2001 Pt calls and says that the injection site is 3"-4" long and wide on arm of swelling and raised area. Y 09/19/2001 09/19/2001 0 PVT PVT Zoloft; Claritin NONE Nemaline rod myopathy 1
0175803 09/28/2001 TX 12.0 12 F 09/22/2001 A couple of hours post vax, the pt broke out in hives all over and this lasted for 1 week. Y 09/10/2001 09/10/2001 0 PUB UNK NONE allergy to bee stings 1
0175804 09/28/2001 NC 45.0 45 F 08/31/2001 Pt complained of swelling of feet and hands; pain in right arm and down right leg; stiffness and pain in neck. Later in the evening, she took Aleve and noticed swelling in hands and ankles and feet right after taking Aleve. She used ice-packs on feet and ankles and swelling went down a little. The next day, it increased. She noticed swelling in joints of wrists, knees, ankles, hands and feet; also ached. Lasted until 8/26/01 and slowly went away. Received 1st and 2nd dose of Hep-B with no side effects. Y 08/23/2001 08/23/2001 0 PUB PVT NONE NONE NONE NC01083 1
0175805 09/28/2001 NC 2.0 2 .3 M 09/18/2001 Elevated temperature by mom's report. Wheals to abdomen, legs and arms which was observed by this nurse. Y Y 08/29/2001 08/30/2001 1 PUB PUB NONE NC01084 1
0175806 09/28/2001 NY 5.0 5 F 09/13/2001 Approximately 40 minutes post vax, the pt complained of something in her throat. she became cyanotic and heart rate was irregular. She was treated with epinephrine, Benadryl and nebulizer/albuterol. The pt recovered. Y Y 07/26/2001 07/26/2001 0 PVT PVT allergy to diary, eggs, wheat and asthma 1
0175807 09/28/2001 OR 1.5 1 .6 M 09/22/2001 The pt experienced a raised red rash with warmth and tenderness at the central area of fine clustered bullae. Y Y 09/19/2001 09/20/2001 1 PVT PVT NONE NONE 1
0175808 09/28/2001 RI 6.0 F 09/24/2001 The pt was exposed to other children who had the vaccine and developed small chicken pox like spots on trunk and extremities. Y Y 09/17/2001 UNK UNK 1
0175809 09/28/2001 OR 1.5 1 .5 F 09/22/2001 The pt experienced palm-sized swelling, erythema, warmth with fine clustered bullae. Y U 09/19/2001 09/22/2001 3 PVT PUB Flovent NONE allergy to milk and soy products, mild persistent asthma 1
0175810 09/28/2001 FL 4.0 4 F 09/21/2001 The pt experienced localized redness, swelling to the left arm and was treated with analgesics and warm compresses. Y 09/20/2001 09/26/2001 6 PVT UNK NONE NONE 1
0175811 09/28/2001 AR 0.4 0 .4 M 05/08/2001 About 1-1 1/2 hours, post vax, mother was feeding the infant and his head and his left arm began to tremble. It was over quickly. Temperature was 99.1F. This has happened about 6 times since 5/2/01, usually when infant is falling asleep or waking up. Saw MD and is getting an appointment with a neurologist for further tests. Y Y 05/02/2001 05/02/2001 0 EEG (about 2-3 weeks after the event) was nml. PUB PUB NONE NONE NONE AR3901 1
0175812 09/28/2001 NY 0.2 0 .2 F 09/25/2001 DTAP and Comvax given 9/17/01. Rash appeared on legs, arms and face on 9/23/01. Tylenol was given. Brought to office on 9/24/01 with pink, flat macules, wheal and target shaped lesions on both legs and arms; 2-3 also on face. Spoke with Infectious Disease Expert and the impression was erythema multiforme secondary to Comvax. Rx'd Tylenol and to keep a close watch. Expected to be fine. U 09/17/2001 09/23/2001 6 CBC with Differential PUB PUB NONE NONE NONE 1
0175813 09/28/2001 VT 33.0 33 F 09/27/2001 20 minutes post vax the pt developed swelling at the site, shortness of breath, tingling of arm, hand, fingers, tightness in throat and chest felt heavy. Was immediately brought to ER. Possible medicine reaction. Y Y 09/13/2001 09/13/2001 0 OTH PVT Tylenol, Albuterol, Flovent NONE allergy 1
0175814 09/28/2001 VA 4.0 4 F 09/26/2001 The pt arrived at the ER complaining of vomiting, screaming, swelling of eyes and was respiratory compromised which started approximately 40 minutes after receiving vax. Y Y 09/26/2001 09/26/2001 0 PUB PUB NONE NONE 1
0175815 09/28/2001 FL 1.5 1 .6 M 09/26/2001 On 9/25/01, the pt experienced erythema around injection site with hives at site. On 9/26/01 the pt experienced a 9 x 5 inch of erythema, indurated around site. No hives around site erythematous below injection site. U 09/24/2001 09/25/2001 1 PVT PVT NONE NONE 1
0175816 10/01/2001 CA 30.0 30 F 09/24/2001 A 30 year old female was vaccinated with varicella virus vaccine lives on 10/31/00. On 12/04/00, the patient received the 2nd dose of varicella vaccine live. The patient's last menstrual period was 11/10/00. The patient has been to the obstetrician gynecologist and has heard the fetal heart beat. The patient reported that her doctor had advised her to terminate the pregnancy. In follow-up, the physician reported that the patient had "terminated the pregnancy shortly after the diagnosis was made". The patient did not have a rash. N 10/31/2000 UNK UNK Zithromax Pregnancy (LMP = 11/10/00). WAES01010192 1
0175821 10/01/2001 TX 50.0 50 F 09/28/2001 It was initially reported on 08/14/01, between 14:00 and 17:00, the vaccinee (white female) received her 1st dose of Engerix-B. Approximately seven or eight hours later, at 24:00, she awoke with a heart rate of 152 beats per minute. Emergency medical services were called, and the vaccinee was taken to the local ER. Upon arrival at the ER, her heart rate was 88 beats per minute, and her blood pressure was 168 / 90 mmHg. The vaccinee took two capsules (strength unk) of diphenhydramine hydrochloride (Benadryl) and went to sleep. The hypertension and tachycardia resolved on 08/14/01. The vaccinee was seen by her personal physician on 08/16/01. The most recent info was received on 09/25/01. The vaccine provider stated that the hypertension and tachycardia were severe in intensity and life-threatening. The vaccine provider considered the events to be possibly related to Engerix-B administration, the vaccinee's personal physician recommended that the vaccinee receive the 2nd dose on Engerix-B. F/U states that the Synthroid dosage was increased to 0.112mg daily. Information received on 10/2/01 indicated that blood chemistry, including assessment of thyroid function, was performed at the ER at 16:24 on 9/24/01. Thyroid function tests revealed a thyroxine concentration of 9.8mcg/dL (reference range, 6.0-12.2), triiodothyronine uptake of 34.3% (referenace range, 32.0-48.4) and a tyroid stimulating hormone (TSH) concentration of 10.85uIU/mL (reference range, 0.34-5.60). An ECG was performed at the ER at 16:36 on 9/14/01. The ECG revealed normal sinus rhythm at a rate of 75 beats/minute. A non-specific ST and T wave abnormality was noted. Other lab findings included an elevated globulin concentration, reduced albumin/globulin (A/G) ratio, reduced mean platelet volume and increased neutrophil count (pleas see lab data section for details). Y Y Y 08/14/2001 08/14/2001 0 Thyroid Function Studies - 08/17/01 - reportedly elevated levothyroxine. ECG-nml sinus rhythm and non-specific ST and T wave abnormality; A/G ratio-1.4 (L); Glob-3.2 (L); MPV-6.7 (L); Neut-66.2 (H); Neuta-6.8 (H); TSH-10.85 (H); TT4-9.8; TT3RU-34.3%; height-60"; weight-173lbs OTH PVT Levothyroxine Sodium (Synthyroid). Hypothyroidism since 1962 20010201451 1
0175831 10/01/2001 MN 1.25 1 .3 F 09/13/2001 The pt developed permanent chronic diarrhea, arersion to eye contact, change in hearing and stopped speaking. Diarrhea and loss of speech were immediate others were gradual onset approximately 1 month. Y N 09/25/1995 09/25/1995 0 PVT PVT NONE NONE diarrhea, rash~Measles + Mumps + Rubella (no brand name)~2~5.00~In Patient 1
0175832 10/01/2001 IA 50.0 50 M 09/20/2001 1 month following 2nd injection, the pt became hot, dizzy with impaired vision. This reoccurred 1 week later and was worse. A CAT scan was performed. The pt remained sun sensitive all summer and was never sensitive before. The pt recovered during the winter months. Problems reoccurred in late Feb in the left great toe. The pt saw a podiatrist, had biopsy. Pain in toe (foot and thigh) lasted 4 months. Problems increased in 7/01 with multiple joint pain and heat sensitivity. Saw MD several times. The pt was treated with 400 mg of Celebrex daily. The pt has an appointment with rheumatologist. Additional information received on 12/26/2001: Patient continues to have symptoms as previously stated. He is being seen by a family doctor and Rheumatologist. After extensive blood tests, they are 99% sure that patient has some type of Lupus, but no definate diagnosis. We feel this was caused by the vaccine. He had no medical problems prior to the injections. Follow up information received 10/18/02 stated, " Pt diagnosed with Lupus. Pt still has some of the same original symptoms and is under doctor's care. He will have to be on medication the remainder of his life." Y N 06/08/2000 07/08/2000 30 ANA - pos, CRP, ESR - elevated, CAT Scan, Skin Biopsy PVT OTH NONE NONE NKA 1
0175833 10/01/2001 LA 0.4 0 .5 M 09/24/2001 The pt experienced an onset of infantile spasms and an abnormal EEG. Follow up information received 10/18/02, stated, " Infantile spasms controlled by meds, long-term developmental outcome - too soon to tell." Y U 07/10/2001 08/10/2001 31 EEG - abn, MRI, lab tests PVT PVT NONE NONE NONE 1
0175834 10/01/2001 MO 1.25 1 .3 F 09/14/2001 The pt experienced a prolonged seizure 16 hours post vax. Temperature at time was 102.5 rectally. Right arms and legs were twitching. 2 months later the pt started having complex partial seizures and was diagnosed with medial temporal sclerosis. The pt is currently on Lamictal to control seizures. Also diagnosed with OM, viral stomatitis, URI. Follow up information receivced 10/21/02 stated, "Brain damage, seizures, epilepsy" Y Y Y 4 Y N 02/04/1999 02/04/1999 0 blood and urine tests - nml, EEG - abnormal, MRI - medial temporal sclerosis PVT PVT Dimetapp otitis media NKA 1
0175835 10/01/2001 MN 1.3 1 .3 M 09/13/2001 The pt experienced chronic permanent diarrhea, chronic "yeast infection" type rashes, change in hearing, loss of eye contact, started to walk on tip toes and spin allot. Y N 09/02/1998 09/03/1998 1 UNK UNK NONE NONE ~Measles + Mumps + Rubella (no brand name)~2~5.00~In Sibling 1
0175836 10/01/2001 MI 2.0 2 .8 F 09/25/2001 Mom complained of "hives" appearing on 9/22/01 PM on butt and top of thigh. No fever, no other symptoms. Never had a reaction to shots before. Took child to doctor, by the time they got there, buttocks were red and tops of backs of thighs was gone. He dx'd "hives". The "hives" come and go and are still present today, 9/25/01. Y Y 08/31/2001 09/22/2001 22 NONE PUB PUB Calamine lotion (eczema); hydrocortisone cream (eczema) NONE Eczema 1
0175837 10/01/2001 NC 4.0 3 M 09/28/2001 Pt developed a fever over 103F with hallucinations. Y Y 09/21/2001 09/21/2001 0 WBC-10,200; CXR-neg PVT PUB NONE NONE NONE Cellulitis~DTP (no brand name)~4~1.00~In Patient 1
0175838 10/01/2001 PA 3.0 3 F 09/25/2001 Pt developed a 5" X 4" large, local reaction less than 24 hours, post vax. Y 09/21/2001 09/22/2001 1 PVT PVT Depakote; Vigabatrin; Synthroid; Claritin NONE Down's Syndrome; Infantile spasms 1
0175839 10/01/2001 WV 1.0 1 .0 M 09/11/2001 The pt received his shots in 8/01, 10 days later, he woke up covered in red bumps; I took him to the ER to find out he had Rubella. Y Y 08/14/2001 08/24/2001 10 PVT PUB NONE NONE NONE 1
0175840 10/01/2001 CA 4.0 4 M 09/14/2001 Pt received DTAP #5 and post vax, there was a red induration. Y 09/12/2001 09/14/2001 2 PUB PUB NONE NONE CA010101 1
0175841 10/01/2001 TX 0.5 0 .5 F 09/17/2001 Inconsolable crying for 5 hours. Treated with Motrin and Benadryl. Y 09/12/2001 09/12/2001 0 PVT PVT 1
0175842 10/01/2001 TN 0.3 0 .4 M 09/20/2000 Had documented temperature by thermometer at 105F. Responded to bath and Tylenol. Y 09/19/2000 09/19/2000 0 NONE PVT PVT NONE NONE NONE 1
0175843 10/01/2001 WA 4.0 4 M 09/24/2001 Pt developed generalized urticaria, about 30 hours, post vax, which lasted 48 hours. Y Y 09/18/2001 09/20/2001 2 PVT PUB NONE Mild URI OM and RAD with URI's 1
0175848 10/01/2001 OH 6.0 M 09/24/2001 Pt presented to our office today with a round red rash on trunk, behind ears and in genital area. Dx'd by our physician as "chickenpox". History of step-sister having same. Y U 04/21/1992 09/24/2001 3443 NONE PVT OTH UNK UNK NONE 1
0175849 10/01/2001 TX 1.6 1 .6 M 09/21/2001 The pt experienced mild hyperemia of cheeks, and facial cheek swelling. Y Y 09/17/2001 09/17/2001 0 PVT PVT NONE febrile seizures AR0140 1
0175850 10/01/2001 MI 13.0 13 M 09/05/2001 13 days post vax, the pt developed 20-30 lesions and no fever. 3 days post vax the pt was seen for a physical and blood draw. The pt fainted 2 times, was seen in the ER and diagnosed with dehydration. No fever, vomiting or diarrhea. Y Y 08/15/2001 08/28/2001 13 NONE PUB PUB NONE NONE NONE MI2001066 1
0175851 10/01/2001 MI 51.0 51 M 09/17/2001 The pt experienced discomfort in left deltoid where TD was given. U 01/06/2001 02/26/2001 51 PUB PUB Prevacid, Tenormin abdominal pain, H-pylori, HTN NONE MI2001068 1
0175852 10/01/2001 MI 1.8 1 .5 F 09/04/2001 The child became irritable, experienced non-stop crying, developed soft ball sized swelling with left leg, thigh seen at ER. No medication given, supportive care only. Resolved in 4-5 days. Y Y 04/27/2001 04/28/2001 1 NONE PUB PUB NONE NONE NONE MI2001069 1
0175853 10/01/2001 MI 15.0 15 F 09/06/2001 Mom said that pt became lethargic, 1 hour, post vax. Then she developed nausea, vomiting and a bad headache. There is no fever on 9/7/01. Follow-up call to mother. She stated that the pt was back in school today but still has a headache. No nausea and vomiting. No doctor follow-up was done. U 09/05/2001 09/05/2001 0 PUB PUB MI2001070 1
0175854 10/01/2001 MI 11.0 11 F 09/10/2001 One day post vax, the pt't arm began swelling, to th axilla, was hot to the touch, red with small hives No fever was given noted. The pt also experienced malaise. The pt is beginning to recover. No diarrhea nor a fever. Y 09/08/2001 09/09/2001 1 PUB PUB NONE NONE allergy to PCN, mild asthma MI2001071 1
0175855 10/01/2001 MI 11.0 11 M 09/18/2001 Parent called to report, after her child had received Hep-B at 09:30. He went to school and completed a day of school but told parent he "felt weird; not like himself" all day. He complained of loss of memory, shakiness and spilling liquids while at school. By 19:30, he complained of itchy eyes and loss of appetite. He went to ER and his only treatment was to take Benadryl po. Y Y 09/17/2001 09/17/2001 0 PUB PUB NONE NONE NONE MI2001072 1
0175856 10/01/2001 MI 4.0 4 M 09/17/2001 Pt awoke the next morning, post vax, with right arm swollen from his shoulder to his elbow. His arm was red and hot to touch. The child was seen at Urgent Care and treated with Cephalexin and hydroxyzine. On Monday, the child's arm was still swollen. Y N 09/14/2001 09/15/2001 1 PUB PUB NONE NONE NONE Welt~DTaP (no brand name)~3~1.00~In Patient MI2001073 1
0175857 10/01/2001 ND 4.0 3 M 09/21/2001 Pt had varivax injection on 3/3/98 and on 9/20/01 he developed low-grade fever and chickenpox. Saw doctor on 9/21/01and was treated with Zovirax. Y Y 03/03/1998 09/20/2001 1297 PVT PUB NONE NONE NONE 1
0175861 10/01/2001 MI 32.0 32 F 08/23/2001 On 8/21/01, client came to clinic for TB test reading. She stated that MMR site had began to redden and swell within a day, post vax. The area of right arm was examined and was warm to the touch. There was a 1 1/2" X 2" area that was pink per caller, noted below injection site. Pt was advised to seek medical care. On 8/27/01, received telephone call from pt stating the she was unable to see physician (clinic closed) but the area was less warm and smaller in size. Y 08/17/2001 08/19/2001 2 PUB PUB TB/PPD/0 previously (8/17/01) MI2001067 1
0175862 10/01/2001 IN 1.6 1 .6 M 09/21/2001 Pt developed erythematous area about 20cm X 15cm in right thigh, around the injection site. No swelling but mildly warmer on the right more than on the left. Not pruritic area. Skin is smooth with no fluctuation. Treated with Duricef 250/5ml 3.5ml po BID. Y U 09/19/2001 09/20/2001 1 NONE PVT PUB NONE NONE Previous bronchiolitis and OM 1
0175863 10/01/2001 TX 12.0 12 F 09/24/2001 Pt received Hep-B (dose #3) at 10:13 on 9/20/01. Pt returned at 19:27, complaining of a rash and itching. Rash was on the abdomen, arms and back. Temperature was 98.2F. Pt was treated with Benadryl 25mg 1 po q6 hours X 5 days and Claritin 1 po q day X 7 days. Y Y 09/20/2001 09/20/2001 0 PVT PVT NONE NONE 1
0175864 10/01/2001 AZ 0.3 0 .4 M 09/21/2001 Pt developed wheezing and increased temperature to 102F after 2nd DTAP, IPV and Comvax. Pt had hives after the 1st DTAP, IPV and Comvax. Y 09/19/2001 09/19/2001 0 PVT PVT NONE NONE 1
0175865 10/01/2001 WV 4.0 4 M 08/18/2001 Pt's right leg was swollen, red, warm to touch and with a knot. Y 08/10/2001 08/11/2001 1 NONE PVT UNK GE Reflux; Bronchitis 1
0175866 10/01/2001 VA 0.3 0 .4 F 09/12/2001 On 5/21/01, six days post vax, the child was found dead in her crib. Preliminary autopsy cause of death was attributed to "sudden unexplained non-traumatic infant death." The autopsy report was amended on 8/15/01 to "acute streptococcus pneumonia. Follow-up info received on 09/10/2001 revealed that on 05/20/2001, the child was fussy at bedtime and was given a dose of Tylenol. Y 05/21/2001 N 05/15/2001 05/21/2001 6 autopsy - acute streptococcus pneumoniae pneumonia PVT PVT Tylenol NONE UNK HQ5314429AUG2001 1
0175867 10/01/2001 OH 1.0 1 .0 F 08/16/2001 A 12 month old female completed the series of Prevnar injections in February 2001. The patient was not receiving concomitant therapy and she had no preexisting illnesses at the time of vaccination. In July 2001 (at the age of 17 months), the patient was hospitalized for Streptococcal pneumoniae osteomyelitis. An unspecified culture was positive for streptococcus pneumoniae. Follow-up information received on 08/03/01 indicated that the child was previously well and considered up to date on her Prevnar vaccinations having received her 3rd dose in 02/01. She presented in June 2001, with a 2 day history of fever between 102 and 103 deg. F. and favoring her left leg. She was seen in the ER on day 2 of illness where examination revealed a blood culture positive for Streptococcus pneumoniae, "mildly" elevated white blood cell count with no shift, and increased erythrocyte sedimentation rate. Ultrasound of hip on day 2 and bone scan on day 3 were negative; however, an MRI on day 4 was positive. A repeat blood culture on day 5 was negative. She was initially treated with IV nafcillin, then switched over to ceftriaxone for 1 week. She then began oral amoxicillin with plans to continue treatment for three weeks. As of 08/03/01, plans were to repeat the bone scan at the end of antibiotic treatment for further evaluation. The S. pneumoniae isolate was not serotyped; however, arrangements were being made to have this done. Follow-up information was received from the original reporter on 08/15/01, which provided the lot numbers and dates of Prevnar doses administered. Also, the patient's birthday was provided; the patient was 15 months of age (several days shy of 16 months) when the events occurred (06/17/01). The following patient had no preexisting illnesses at the time of the vaccination and had no history of adverse events following previous vaccination. The reporter also noted that the patient received Varivax (MSD) and Engerix B (SKB) vaccines within 4 weeks of receiving Prevnar, but dates were not provided. The patient recovered. Y Y 4 Y 02/26/2001 06/17/2001 111 07/00/01 - Blood Culture - Positive for streptococcus pneumoniae within 24 hours. Repeat culture on day 5 was negative. White Blood Cell Count - increased mildly elevated with no shift. Erythrocyte Sedimentation Rate - increased. Ultrasound scan of hip - on day 2 Nml. Scan bone - on day 3 was Nml. Nuclear Magnetic Resonance Imaging - day 4 was positive. PVT PVT NONE NONE UNK HQ3830330JUL2001 1
0175868 10/01/2001 FL 1.25 1 .3 F 08/14/2001 On 3/6/01 the pt developed choking, eyes rolling to the back of the head, and tremors in all extremities. She also appeared to stop breathing with perioral cyanosis. She received cardiopulmonary resuscitation and was transported to the ER. Upon arrival to the ER she had a fever of 102. Y Y 1 Y 03/05/2001 03/06/2001 1 03/06/01 Blood electrolyte NOS normal - Na 135; K 4.4; C1 109; CO2 20; Glucose 98; BUN 15; Creatinine 0.4; Calcium 10.1. Urinalysis - Nml. CSF cell count NOS - Nml. CSF culture - Neg. OTH OTH NONE NONE UNK HQ4422108AUG2001 1
0175869 10/01/2001 CO U 06/11/2001 A physician reported that a young child received the 1st dose of Prevnar and subsequently developed an injection site reaction characterized by erythema, induration, swelling, and tenderness. No fever was noted. The induration was described as "persistent", lasting more than 7 days. The child recovered. The reporter felt this reaction was medically important. MANUFACTURER'S COMMENT: The reporter indicated that 2 children experienced this event; however, they are not presently identifiable. An additional report will be generated when identifying information is provided. Y UNK OTH OTH UNK UNK UNK HQ1848808JUN2001 1
0175870 10/01/2001 IL 0.4 0 .4 F 08/01/2001 A 5 month old infant received a 2nd dose of Prevnar. Subsequently, the infant was hospitalized with a diagnosis of pneumococcal meningitis. No further info was available at the date of this report. Follow up info received from the physician on 07/23/01, indicated that a 5 month old female received an injection of Prevnar on 05/16/01. On 05/28/01, the child was hospitalized and diagnosed with pneumococcal meningitis. Blood and cerebral spinal fluid cultures were positive for Streptococcus pneumoniae. Gram positive cocci were seen in a gram stain of cerebral spinal fluid. A bacterial antigen panel was positive for Streptococcus pneumoniae. Lumbar puncture results on 05/28/01, showed white blood cells at 50/ cu mm, total protein of 329 mg/dl., neutrophils at 46 %, bands at 37 %, Lymphocytes at 15 % and monocytes at 1 %. The infant recovered. Y 12 Y 05/16/2001 05/28/2001 12 Blood and cerebral spinal fluid cultures were positive for Streptococcus pneumoniae. Gram positive cocci were seen in a gram stain of cerebral spinal fluid. A bacterial antigen panel was positive for Streptococcus pneumoniae. Lumbar puncture results on 05/28/01, showed white blood cells at 50/ cu mm, total protein of 329 mg/dl., neutrophils at 46 %, bands at 37 %, Lymphocytes at 15 % and monocytes at 1 %. OTH OTH UNK NONE UNK HQ2190118JUN2001 1
0175871 10/01/2001 IL 5.0 U 07/05/2001 A company representative reported that a 5 year old child was admitted to the hospital with a diagnosis of pneumococcal meningitis. No further information was available at the date of this report. Y U UNK PVT OTH UNK UNK UNK HQ1910211JUN2001 1
0175872 10/01/2001 0.3 M 06/19/2001 On 10/12/00 the child was hospitalized for pneumococcal sepsis. A blood culture was obtained on 10/12/00 yielded the presence of streptococcus pneumoniae. The child recovered and was discharged seven days later. This case has been determined to be a duplicate of report HQ2678324OCT2000. A physician reported that a 4 month old male received his first dose of Prevnar, Hib-Titer, Acel-immune, IPV (manufact unknown), and his second dose of Recombivax-HB(MSD) vaccines on 21-Aug-2000. Y 7 Y 08/21/2000 10/12/2000 52 10/12/2000 blood culture penicillin- resistant Streptococcus pneumonia present. OTH OTH UNK UNK UNK HQ1799407JUN2001 1
0175873 10/01/2001 GA 1.5 M 08/01/2001 The pt experienced rotavirus three months after vax. He was hospitalized twice. He almost died. No medical history and no further details were provided. Follow up info received on 11/9/01, upon review of the case, the recovery status was changed to "unknown." Y U UNK OTH OTH UNK UNK UNK HQ3850130JUL2001 1
0175874 10/01/2001 PA U 08/16/2001 A healthcare professional reported that an unspecified number of pts experienced site "discomfort", subsequent to Prevnar administration. The reporter considered the event due to the needle, not the vaccine. No further information was available at the time of this report. U UNK OTH OTH UNK UNK UNK HQ1965412JUN2001 1
0175875 10/01/2001 MO 0.5 0 .5 M 06/15/2001 A physician reported that a 6 month old male received his 1st dose of Prevnar and his 3rd dose of DTAP vaccines on 3/15/01. That day, he developed hives, irritability and lethargy. He was seen in Urgent Care and treated with diphenhydramine. He recovered. Y Y 03/15/2001 03/15/2001 0 UNK PUB PUB NONE UNK UNK HQ1985512JUN2001 1
0175876 10/01/2001 IN U 07/17/2001 A nurse reported that a child received an injection of Prevnar and subsequently, developed a "red lacey rash all over". The child also developed swelling at the injection site. No further information was available at the date of this report. The reporter declined to provide information for follow-up investigation. U UNK PVT OTH UNK NONE UNK HQ2066914JUN2001 1
0175877 10/01/2001 8.0 F 07/03/2001 A mother reported that her 8 year old daughter with common variable immunodeficiency received Prevnar "in the standard procedural way for a child on gamma globulins". Following immunization, her serum antibody value was measured to be lower than her pre-immunization value. She was seen by the physician who had the lab run the test again. No further information was available at the date of this report. U Antibody NOS-abnormal (decreased) OTH OTH UNK UNK Immunodeficiency common variable HQ2236819JUN2001 1
0175878 10/01/2001 NY U 07/10/2001 A pharmacist reported that a child received a dose of Prevnar and subsequently developed hoarseness. The child recovered. No further information was available at the date of the report. Y UNK OTH OTH UNK UNK UNK HQ3077710JUL2001 1
0175879 10/01/2001 PA 1.5 F 07/23/2001 A mother reported, via a company representative, that her 18 month old daughter received the 1st dose of Prevnar vaccine in 11/00. In 12/00, the child developed wheezing and coughing. The mother also reports that her child has been treated with antibiotics every month for ear infections since receiving Prevnar; however, her lungs were clear. In 4/01, the child developed bilateral ear infections with continued cough and was given a dx of Pneumonia. The child recovered. No additional information was available as of the date of this report. See Case ID HQ3176412JUL2001 for AE of bronchiolitis following the 2nd dose of Prevnar for this child. See Case ID HQ3176512JUL2001 for AE in sibling following 1st dose of Prevnar. Y Y 11/01/2000 04/01/2001 151 UNK PVT OTH UNK UNK UNK HQ3082310JUL2001 1
0175880 10/01/2001 PA 2.0 2 .1 F 08/07/2001 A nurse reported that a 24 month old female received her 1st dose of Prevnar on 7/9/01. Within 5 hours, post vax, the child developed generalized hives. She was given oral Benadryl. On 7/10/01, the child was seen by the physician who noted a temperature of 99.9F and that the child appeared uncomfortable. Additional information received from the reporter on 7/31/01 provided the route and site of administration, past drug hypersensitivities and stated that the child recovered. Y Y 07/09/2001 07/09/2001 0 NONE PVT OTH UNK NONE Drug hypersensitivity HQ3140711JUL2001 1
0175882 10/01/2001 VA 0.75 0 .8 M 08/21/2001 A nurse reported that a 9 month old male received a dose of Prevnar on 7/16/01. Two days later, the mother reported that her son developed an injection site reaction characterized by a 2" area of bruising, erythema and induration. The reporter noted that the Prevnar vial contained particulate matter. Additional information received from the reporter on 8/20/01 provided concomitant vaccines, lot numbers, routes and sites of administration and stated that Hep-B was administered in the same thigh as the Prevnar. The child recovered. Y 07/16/2001 07/18/2001 2 UNK OTH OTH UNK NONE UNK HQ3638725JUL2001 1
0175883 10/01/2001 NJ U 07/26/2001 A physician reported that a child received a dose of Prevnar and subsequently, experienced flu-like symptoms. The reporter indicated that several children experienced this event following receipt of Prevnar; however, they are not presently identifiable. Additional reports will be generated when identifying information is provided. Y U UNK PVT PVT UNK NONE UNK HQ3674525JUL2001 1
0175884 10/01/2001 NV 0.75 0 .8 F 08/20/2001 A mother reported that her 9 month old daughter received Prevnar and Inactivated Poliomyelitis vaccines on 7/23/01. On 7/24/01, the infant developed a fever, which peaked at 101.5F and was up all night crying. She also developed eczema on her face, which is now chaffed and bleeding with red cheeks. She developed an injection site reaction, at the location of the Prevnar immunization, that "looks like a mosquito bite and about the size of a dime". The mother reports that her daughter is presently seeing an allergist and has been tested for allergies. U 07/23/2001 07/24/2001 1 UNK PVT PVT Singulair; Zyrtec NONE Food allergy; Acne infantile; Drug hypersensitivity; Hypersensitivity NOS HQ3749426JUL2001 1
0175885 10/01/2001 CA 1.0 M 08/27/2001 A mother and a pharmacist reported that a 12 month old male received his 1st dose of Prevnar vaccine and subsequently was unable to bear weight on his right leg. Prior to immunization, the child was able to stand on his own, take 3 to 4 steps, lean on furniture and walk. He was seen by his doctor who described the symptoms as "no weight bearing". At the date of this report the event has continued for 2 to 2.5 months. No additional information was available as of the date of this report. Additional information received on 8/2/01, contained the name and address of Orthopedic MD. Additional information received on 8/6/01, contained name and address of pharmacist. A 15-day follow up report received 10/09/2001 adds: Laboratory data includes x-rays and blood tests (unspecified) with negative results. Orthopedic physician indicated that child was disabled for 4 months. This case was upgraded to serious based on new info stating that child was disabled for 4 months. Y U 05/08/2001 X-ray NOS-neg; Blood tests (unspecified)-neg PVT OTH UNK UNK UNK HQ3906131JUL2001 1
0175886 10/01/2001 CA 2.0 M 08/07/2001 A physician reported that a 31 month old male received a dose of Prevnar. On 6/5/01, he developed an injection site reaction characterized by swelling, pain and bruising. The child experienced vomiting, loss of appetite and right hip pain. The reporter indicated that Prevnar administration has caused "more adverse events than before". No further information was available at the date of the report. U 06/05/2001 UNK OTH OTH UNK UNK UNK HQ3956101AUG2001 1
0175887 10/01/2001 NY U 08/07/2001 A company representative reported that an infant received an injection of Prevnar. One month, post vax, the infant developed bloody stools. No further information was available at the date of this report. The reporter indicated that 2 infants experienced this event; however, they are not presently identifiable. An additional report will be generated when identifying information is provided. U UNK PVT PVT UNK UNK UNK HQ4056403AUG2001 1
0175888 10/01/2001 U 08/28/2001 A company representative reported that 3 unidentified children received Prevnar vaccine and subsequently developed "duskiness" in the face and around the mouth". No additional information was available as of the date of this report. The reporter indicated that 3 children experienced this event; however, they are not presently identifiable. Additional reports will be generated when identifying information is provided. U UNK OTH OTH UNK UNK UNK HQ4394308AUG2001 1
0175889 10/01/2001 DE 1.4 1 .5 M 08/20/2001 A consumer reported that her 17 month old son received Prevnar, diphtheria and tetanus toxoids and acellular pertussis (DTAP) and "other unknown vaccines" on the afternoon of 5/15/01. At that same time and date, the child was dx'd with sinusitis and started on amoxicillin therapy. The following day, the child felt warm in the morning and that afternoon experienced a fever of 104.9F. The fever lasted 4 days. The child also would hit his head with his hands during those 4 days. As of the date of this report, no further information was available. Y 05/15/2001 05/16/2001 1 UNK PVT OTH Wymox Sinusitis UNK HQ4524309AUG2001 1
0175891 10/01/2001 NY 3.0 3 M 09/10/2001 A physician (allergist) reported that a 3 year old male received his 1st dose of Prevnar on an unspecified date. Concomitant vaccinations were unknown and his medical history was not provided. Two weeks, post vax, the pt experienced fever, swollen and purple joints and "bright red skin" "upon stroking". He was treated with unspecified steroids for several days. The reporting physician was concerned about the possibly of serum sickness. Follow-up info was received on 09/05/2001 from the pt's pediatrician. The pt had no pre-existing illness at the time of vaccination and had no previous adverse events with prior vaccination. Medical history included hypopituitarism and it was noted that the child had been induced prematurely. The date of vaccination with Prevnar was 06/19/2001 and the events occurred on 07/12/2001. The events now were noted to have included an urticarial rash and painful fingertips. U 06/19/2001 07/12/2001 23 UNK OTH OTH Human growth hormone, recombinant; unspecified vitamins UNK Hypopituitarism, premature baby HQ4808916AUG2001 1
0175892 10/01/2001 VA U 08/31/2001 A nurse reported that an infant received a dose of Prevnar and experienced burning at the injection site along with crying and screaming. The reporter indicated that these events occurred with other children; however, they are not presently identifiable. Additional reports will be generated when identifying information is provided. No further information was available at the date of the report. U UNK OTH OTH UNK UNK UNK HQ5102123AUG2001 1
0175893 10/01/2001 FL 9.0 9 M 08/27/2001 A mother reported that her 9 year old son received doses of Prevnar and Hep-A vaccines on 6/2/00. In 10/00, she noticed that her son was losing weight. By 1/01, her son had lost 10 lbs. He was subsequently, seen by his pediatrician. On 3/16/01, her son received a second dose of Prevnar. At that time he had developed bulging eyes, weight loss with increased appetite and had lost 14 lbs. In 5/01, her son was dx'd with Graves disease. The reporter noted that she requested the pediatrician to report this event; however, he declined since "he felt that it (Graves disease) had nothing to do with the vaccine". No further information was available at the date of the report. Follow-up info received from the child's pediatrician on 10/08/2001 stated that on 03/16/2001, the child received prevnar and Hep a vaccines. "It is my medical opinion that his shots on 03/16/2001 did not cause or contribute to his graves disease." Follow-up info changed suspect vaccine to Pnu-Imune 23. U 06/02/2000 10/01/2000 121 UNK PVT PVT NONE NONE UNK HQ5158324AUG2001 1
0175894 10/01/2001 TX 0.7 0 .7 F 08/28/2001 A MA reported that an 8 month old female received her 4th dose of Prevnar on 8/21/01. On 8/23/01, the infant developed an abscess at the injection site. The infant was treated with cefaclor for 10 days. No additional information is available as of the date of this report. Y U 08/21/2001 08/23/2001 2 UNK PVT PUB NONE UNK UNK HQ5219127AUG2001 1
0175895 10/01/2001 TX 1.2 1 .2 F 09/12/2001 A MA reported that a 14 month old female received a 5th dose of Prevnar on 8/20/01. On 8/20/01, she also received DTAP, Poliomyelitis and haemophilus B conjugate vaccines. On 8/23/01, the child developed an abscess at the injection site. The location of the injection site was not specified. She was treated with cefaclor for 10 days. No additional information was available as of the date of this report. This is 1 of 2 pts from this facility who experienced this event, post vax, of 2 different lots of Prevnar. U 08/20/2001 08/23/2001 3 UNK PVT PUB UNK UNK UNK HQ5220927AUG2001 1
0175896 10/01/2001 NJ 0.2 0 .2 F 09/06/2001 A nurse reported that a 2 month old female received injections of Prevnar (1st dose), Infanrix, IPV and Act-Hib on 8/28/01. Several hours, post vax, both of the pt's legs turned purple from the hips to toes. This lasted over 20 minutes. The responsible physician did not believe the reaction was due to the vaccination, but a different physician felt there was indeed a causal relationship. U 08/28/2001 08/28/2001 0 UNK PVT OTH NONE NONE UNK HQ5436631AUG2001 1
0175897 10/01/2001 NJ 0.4 0 .3 F 09/06/2001 A pediatrician has reported that a white female child received his 1st dose of Prevnar. The date of Prevnar administration and any concomitant vaccines were not reported. On an unspecified date, the child experienced a systemic rash. No further information was available at the date of this report. Followup information has been received on 5 OCT 2001 from the initial reporter concerning the 4 month old female child (age/gender clarified). On 16 AUG 2001, the child received her first injection. The chold received no concomitant vaccines and was taking no other medications. Four days later, on 20 AUG 2001, the child experienced a systemic rash. The child has recovered. U 08/06/2001 08/20/2001 14 UNK OTH OTH UNK UNK UNK HQ5442331AUG2001 1
0175898 10/01/2001 PA U 06/11/2001 A nurse reported that a pt received an injection of Prevnar and experienced pain at the time of administration. She indicated that this particular vaccine appears to be causing more discomfort that the other vaccine products administered. The reporter indicated that other children have experienced this event but she was unable to specify the number of pts involved. Additional reports will be generated when identifying information is received. No further information was available at the date of this report. U UNK OTH OTH UNK UNK UNK HQ1762607JUN2001 1
0175899 10/01/2001 NJ 1.5 F 06/11/2001 A mother reported her 18 month old daughter received her 1st injection of Prevnar at age 18 months (date not specified). The child received "other vaccines" on that same date. Subsequent to vaccination, the child developed an injection site reaction characterized by a hardened area. The mother also reported the child developed injection site dermatitis and fever following her 2nd dose of Prevnar at age 28 months. N UNK UNK HQ1856508JUN2001 1
0175900 10/01/2001 CO U 08/27/2001 A physician reported that a patient received an injection of Prevnar and diphtheria, tetanus and acellular pertussis (manufacturer unk) vaccines and subsequently, developed an injection site reaction at the Prevnar administration site characterized by pronounced redness, raised skin and increased stinging and pain "than compared to DTaP injection." MANUFACTURER'S COMMENT: This is 1 of 2 patient's from this facility of adverse events who experienced an injection site reaction following Prevnar administration. U UNK PVT PVT UNK UNK UNK HQ1860808JUN2001 1
0175901 10/01/2001 PA 0.4 M 07/05/2001 A physician reported that a 5 month old infant received an injection of Prevnar and subsequently developed an injection site reaction characterized by redness and swelling approximately 4 inches in diameter. The infant recovered. Additional info from the physician on 07/03/01 provided the lot # and date of the vaccination. Y Y 06/13/2001 UNK PVT OTH NONE NONE UNK HQ2267219JUN2001 1
0175902 10/01/2001 CA 0.5 0 .5 F 08/21/2001 A physician reported that a 6 month old female, with a history of allergic colitis, received her third dose of Prevnar, ActHIB (Aventis Pasteur SA), and Infanrix (SKB) vaccines on 06/12/01. On 06/14/2001, the infant developed blood in her stool. The reporter described this as allergic colitis. The infant was "symptoms free after changes in her and the mother's diet (breastfeeding). Info regarding this event has been forwarded to Aventis Pasteur and SKB, manufacturers of the concomitant vaccines. Y 06/12/2001 06/14/2001 2 UNK PVT PVT NONE NONE Cow's milk intolerance; Enterocolitis; Proctocolitis. HQ2378121JUN2001 1
0175903 10/01/2001 IN U 08/17/2001 A nurse reported that a child (age and gender unspecified) developed a rash described as a " few red spots" following the administration of Prevnar. No further info was available at the time of this report. The patient was one of four patients from the same facility reported to have developed a rash subsequent to Prevnar vaccination. U UNK OTH OTH UNK UNK UNK HQ2389221JUN2001 1
0175904 10/01/2001 CO 1.7 1 .7 M 08/01/2001 A nurse reported that 10 minutes post vax, the pt developed welts and a rash over his body. He was treated with Zyrtec 1/2 tsp/day and Benadryl 3/4 tsp to 1 tsp as needed for 3 days. The pt recovered. Additional information received from the reported indicated that a the time of vax, the pt was taking Cezil. The pt remained recovered. Y 06/27/2001 06/27/2001 0 UNK PVT PVT Cefzil NONE UNK HQ2714429JUN2001 1
0175905 10/01/2001 IN 5.0 5 U 07/10/2001 A physician reported that two days subsequent to receiving vax, the pt developed an injection site reaction characterized by a 15 cm area of redness and swelling. The pt was treated with Tylenol and recovered. No further information was available at the date of the report. Y 06/04/2001 06/06/2001 2 UNK OTH OTH NONE NONE UNK HQ2734502JUL2001 1
0175906 10/01/2001 TX U 07/10/2001 A medical assistant reported that subsequent to receiving a dose of Prevnar, a pt developed a high fever along with an injection site reaction characterized by redness, swelling and pain. The pt recovered. The reporter indicated that several pts experienced these events, however they are presently not identifiable. Additional reports will be generated when identifying information is provided. Y UNK OTH OTH UNK UNK UNK HQ2798503JUL2001 1
0175907 10/01/2001 KY 0.8 0 .8 F 07/30/2001 A physician reported that within a couple of days post vax, the pt developed diarrhea and irritability. As of Jul 19, 2001, the pts diarrhea persists. No further information was available at the date of the report. U 07/03/2001 07/05/2001 2 UNK PUB OTH NONE NONE UNK HQ3624524JUL2001 1
0175909 10/01/2001 U 08/27/2001 A mother reported that 30 minutes subsequent to receiving Prevnar and two other unknown vaccines, the pt developed a rash on the palms of the hands. The rash lasted for 10 days and was still present to the date of this report. She also mentioned that the health care provider did not know the cause of the rash. She declined to give additional information. U UNK OTH OTH UNK UNK UNK HQ4394408AUG2001 1
0175910 10/01/2001 MN 6.0 6 F 08/27/2001 The of receiving vax, pt developed redness at the injection site. The area of redness measured 3-4" in diameter. No addtl information was available as of the date of this report. Manufacturer's Comment: This pt is 1 of 2 patients who experienced this event following receipt of Prevnar lot 479-792. The reported indicated that 3 pts experienced this event; however, 1 is not presently identifiable. An addtl report will be generated when identifying info is provided. U 07/31/2001 07/31/2001 0 UNK OTH OTH NONE UNK UNK HQ4784115AUG2001 1
0175911 10/01/2001 IN U 08/17/2001 A nurse reported that 2 unidentified children developed a rash following the administration of Prevnar. No further info was available at the time of this report. These pts were 2 of 4 children from the same facility reported to have developed a rash subsequent to Prevnar. See related cases HQ2329820JUN2001 and HQ2389221JUN2001 for the reports on the other two children. U UNK OTH OTH UNK UNK UNK HQ4856517AUG2001 1
0175912 10/01/2001 UT 0.6 0 .7 M 08/21/2001 Mother reported that subsequent to receiving vax pt developed a mild fever and recovered. No further info was available at the date of the report. Y 07/06/2001 UNK PVT PVT NONE NONE UNK HQ4922320AUG2001 1
0175913 10/01/2001 MN 6.0 6 M 08/27/2001 Nurse reported that one day post vax pt developed redness at the injection site. The area of redness measured 3-4" in diameter. No addtl info was available as of the date of this report. Manufacturer's Comment: This is 1 of 2 pts who developed injection site erythema following receipt of Prevnar lot 479-792. The reporter indicated that 3 pts experienced this event; however, 1 is presently not identifiable. An addtl report will be generated when identifying info is provided. U 07/18/2001 07/19/2001 1 UNK OTH OTH NONE UNK UNK HQ5150323AUG2001 1
0175914 10/01/2001 UT 1.25 1 .3 U 08/28/2001 A medical assistant reported that one day post vax pt developed hives and subsequently recovered. No further info was available at the date of this report. Y 08/23/2001 08/24/2001 1 UNK PVT OTH NONE NONE UNK HQ5263528AUG2001 1
0175915 10/01/2001 IL 1.5 F 08/28/2001 Within 72 hours of receiving vax, pt developed a fever of 104F. No further info was available at the date of the report. U 08/08/2001 08/11/2001 3 UNK PVT OTH UNK UNK UNK HQ5264328AUG2001 1
0175916 10/01/2001 NY 0.25 U 08/31/2001 A pediatrician reported that post vax pt developed fever, diarrhea and crankiness. No addtl info was available as of the date of this report. U UNK PVT PVT UNK UNK UNK HQ5389230AUG2001 1
0175918 10/01/2001 NJ 2.0 2 .3 F 06/11/2001 Mother reported that day of receiving vax pt developed an injection site reaction characterized by a rash on her left thigh. The rash was managed with hydrocortisone cream as instructed by health care provider. The rash resolved on 5/27/01. Three days post vax, pt developed a fever of 102F. The fever continues and usually occurs in the afternoon or evening. The pt's pediatrician told mother "that fever may be viral and didn't believe it was due to the Prevnar." U 05/25/2001 05/25/2001 0 6/4/01 CBC & Epstein Barr-results pending PVT OTH Zyrtec UNK UNK Hardened area at injection site~Pneumo (Prevnar)~1~1.50~In Patient HQ1697706JUN2001 1
0175919 10/01/2001 PA 0.4 0 .5 M 08/01/2001 Mother reports that 1 day post vax pt's (nonspecific) skin condition worsened. Prior to vax, the condition existed around his neck and in the fatty folds. He was treated with Keflex prophylactically "for a reaction." Since receipt of Prevnar, pt's condition spread to his face and over his body. The pt does not sleep well. Info from the pt's dermatologist indicated that the pt was diagnosed with group B Strep intertrigo on his first visit of 5/9/01. At his second visit on 6/4/01, pt had multiple, erythematous, hyperkeratotic crusted plaques, some annular on cheeks, neck folds, umbilicus, axilla, groin, exterior folds of lower extremities and a few pustules. On third visit 6/13/01 pt presented with scattered erythematous papulopustules and scaly plaques in neck folds, central abdomen, and flexoral aspects of lower extremities. After tests, a diagnosis of "psoriasiform dermatitis favor psoriasis" was made. At the pt's last visit on 7/11/01, he presented with erythematous plaques, small pustules on anterior trunk, cheeks and flexors. Y U 05/31/2001 06/01/2001 1 6/4/01 WBC 14,400; platelet count 475,500; differential WBC eosinophils 6.4%. 6/14/01 skin biopsy of neck and leg-psoriasiform dermatitis OTH OTH Keflex Skin disorder UNK HQ1760207JUN2001 1
0175921 10/01/2001 CT U 06/15/2001 A pediatrician reported that 3 patients (age 12 - 15 months) who received Prevnar, MMR, and Varicella vaccine experienced various adverse reactions. The reactions included vasculitis, bruising, soreness, and joint swelling. Individual patient info and vaccination dates / history were not provided. U UNK PVT OTH UNK UNK UNK HQ1656405JUN2001 1
0176118 10/01/2001 CA 7.0 7 F 09/14/2001 Seconds after receiving immunizations this child flew out of her chair at 3 feet away from the chair, bumping the right side forehead on the floor, causing a 1-1 1/2 inch bruise. Child alert to name , place and father and brother and sister. No complains of positions. (+) PERRLA, 3 mm pupils. BP 106/60, HR 60. Father told to get evaluation at the hospital. Y 09/14/2001 09/14/2001 0 PUB PUB NONE NONE CA010103 1
0175922 10/02/2001 KY 0.3 0 .3 F 05/18/2001 Death. Found unresponsive and blue on 05/18/01. CPR attempted but unsuccessful. Autopsy lists cause of death as "undetermined" as the differential diagnosis of SIDS vs parental caregiver overlay cannot be determined on autopsy findings alone. Y 05/18/2001 N 05/14/2001 05/18/2001 4 PVT PUB Sudafed, Amoxil, Tylenol otitis media NONE KY2001068 1
0175927 10/02/2001 TN 4.0 4 M 09/05/2001 The pt experienced vomiting, wheezing, seizures, encephalitis, acute disseminated encephalomyelitis. Was taken by lifeline EMS to the hospital. The pt remains in rehab. Y Y Y 28 Y 07/06/2001 07/21/2001 15 MRI, CT Scan, blood work PVT UNK NONE NONE 1
0175928 10/02/2001 MI 8.0 8 F 09/25/2001 The pt experienced an area around the injection site which was red the day after the injection. On 9/9/01 the child began with headache, by 9/11/01 the child was dizzy and confused, had a temp of 99.0, and then seizures began. The pt was life flighted to the hospital. The annual follow up states "spoke with mother 11/14/02. Pt continues on anti-seizure rx. Caigetrol 800mg/day and has had no more seizure activity. Saw neurologist today and will then be followed yearly. Doing well in school, personality ahs returned to pre-vaccine normal. The 60 day follow up received on 1/15/02 states pt is improving according to her mother. She continues to need seizure medication. Her last EEG was done 12/01, it remained abnormal. She sees the neurologist every 3 months. She's beginning to better in school and her personality is more like "the old self." Y Y Y 9 Y N 08/22/2001 08/23/2001 1 spinal tap, WBC, Glucose, protein, bacterial antigen PUB PUB NONE seasonal allergies 1
0175929 10/02/2001 IN 0.6 0 .6 M 09/24/2001 The pt experienced episodic twitching of shoulders and hives. Y 1 Y 09/24/2001 09/24/2001 0 PVT UNK NONE eczema 1
0175930 10/02/2001 IL 1.25 1 .4 M 09/26/2001 The pt experienced a low platelet counts, numerous IV gamma globulin's, finger sticks, bruising, steroid treatment and finally remover of his spleen three years later. The annual follow-up states that "he is watched for signs of bruising and any fever is cause for concern since he lost his spleen due to chronic ITP, and he's on penicillinf for life and he's six." Y Y 2 U 10/28/1997 01/02/1998 66 bone marrow PVT OTH NONE NONE ear infections, tubes in ears at 18 months 1
0175931 10/02/2001 NY 0.2 0 .2 M 09/24/2001 The pt experienced fussiness, not eating well, screaming. The pt was taken to the ER and had blood work and urine done. The pt refused spinal tap and was discharged. The pt was then seen by an "on call" pediatrician on 8/11 with a temp of 102.7 and was admitted to the medical center. A spinal tap was performed and the pt was treated with IV antibiotics. The pt had possible spinal meningitis. Y 3 Y 08/09/2001 08/10/2001 1 blood culture and CSF - neg PVT PVT NONE NONE NONE 1
0175932 10/02/2001 MD 0 .0 M 09/26/2001 The pt developed a fever of 101 rectally. Was admitted to hospital for full septic work up. Y 3 Y 09/20/2001 09/20/2001 0 CBC, Blood, U/A, CSF analysis, - neg PVT PVT NONE NONE NONE 1
0175933 10/02/2001 MT 0.2 0 .2 M 08/02/2001 Within an hour of shots, the baby had low-grade fever to high-grade fever of 101F, anorexia, throwing up and excessive fussiness for 2 days, despite a round the clock Tylenol. Prevnar shot. Y 05/10/2001 05/10/2001 0 NONE PUB PVT NONE NONE NONE MT0113 1
0175934 10/02/2001 NY 1.0 1 .0 M 09/27/2001 On 9/25/01, pt developed a temperature of 39.4C and had a seizure at home. He was taken to ER, observed and released. Y Y 09/24/2001 09/25/2001 1 CBC-nml OTH OTH NONE Vomited X 1; diarrhea 1
0175935 10/02/2001 CA 1.0 1 .1 M 09/25/2001 Pt developed a whole body, maculo-papular rash. No fever or real blisters. U 09/12/2001 09/18/2001 6 NONE PVT PUB Augmentin Right OM NONE 1
0175936 10/02/2001 MI 0.2 0 .2 M 09/21/2001 Pt received DTAP, HIB, IPV, HEP-B and PREVNAR vaccinations on 9/12/01. Upon returning home, the baby cried inconsolably for approx. 6 hours. Instructed mom to bring him into the office for a re-check. At that time, the baby was fine and had recovered completely. Y 09/12/2001 09/12/2001 0 NONE PVT PVT NONE NONE NONE 1
0175937 10/02/2001 CA 0.3 0 .3 M 09/25/2001 Extreme irritation for 8 to 12 hours, post vax. Y 07/25/2001 07/25/2001 0 PVT UNK NONE NONE 1
0175938 10/02/2001 AL 1.0 1 .1 M 06/29/2001 Pt developed erythema multiforme minor. Y U 06/25/2001 06/27/2001 2 NONE PVT PVT Amoxil BOM and URI Benign macrophaly; Right ocular nevus 1
0175939 10/02/2001 MO 1.0 1 .3 M 09/10/2001 Father states that the pt's arm was swollen. On 9/6/01, it was warm and red. Mother took pt to physician who told parents he had an allergic reaction and the physician prescribed Keflex and Cipro. Father states that the child is fine and arm has no swelling and inflammation is gone. Y Y 09/05/2001 09/06/2001 1 NONE PUB PUB NONE NONE 1
0175940 10/02/2001 ID 1.0 1 .1 M 09/24/2001 Pt had what mom stated "as a few chickenpox" on and off for over 2 months, post vax. Y 07/11/2001 PVT OTH NONE NONE NONE 1
0175941 10/02/2001 CT 0.5 0 .5 M 09/21/2001 Blotchy, erythematous rash on trunk and extremities. Treated with Benadryl 1/2 tsp q 4 hours, prn. Y 09/20/2001 09/21/2001 1 PVT PUB NONE NONE 1
0175942 10/02/2001 MT 0.4 0 .4 M 09/06/2001 Pt was given shots on 8/2/01 and 8 hours, post vax, the baby started vomiting, temperature was 101F, he was fussy, and with a bright red, hot and tender lump at Prevnar injection site. Mother gave him Tylenol/ibuprofen. The baby remained not acting himself for 48 hours. Mother calls nurse. Y 08/02/2001 08/02/2001 0 NONE PUB PUB NONE NONE Allergies to molds MT0112 1
0175943 10/02/2001 MT 0.8 0 .8 F 08/01/2001 Post vax, the next morning, the pt has high-grade fever of 102.9F. The fever continued and on 6/18/01, her temperature was 101.4F, she had anorexia and fussiness. Parent takes baby to the doctor on 6/18/01. Baby takes ibuprofen and rash started from head down to feet and entire body which lasted until 6/22/01. All this, despite Tylenol and ibuprofen around the clock. Y 06/14/2001 06/15/2001 1 NONE PUB PUB NONE NONE NONE MT0114 1
0175944 10/02/2001 MT 1.75 1 .7 F 09/06/2001 On 4/11/01, about 6 hours later, around 03:00, the child awakens crying, throws up, has a high fever of 101F(R). She also has a 3" lump that is bright red and hot at the injection site. The child ran a fever and was sick for 4 days despite around the clock Tylenol and ibuprofen. Y 04/10/2001 04/11/2001 1 NONE PUB PVT Daily multi-vitamins NONE NONE MT0115 1
0175945 10/02/2001 WA 1.0 1 .0 F 08/20/2001 A 1 year old female received MMR on 8/9/01 and on 8/19/01 she developed a rash on her face, head, neck and migrating down her body. No fever. She had a mild runny nose. Reassurance. Dx'd with measles rash secondary to vaccine. U 08/09/2001 08/19/2001 10 NONE PVT PUB NONE NONE NONE WA011780 1
0175946 10/02/2001 WA 0.6 0 .6 F 08/10/2001 Pt had inconsolable crying X 5 hours, like she was in pain. No sign of swelling or redness at site. Y Y 08/09/2001 08/09/2001 0 Normal exam with tachycardia from crying PVT PUB WA011778 1
0175947 10/02/2001 NC 0.2 M 09/20/2001 Pt had hot, red and tender thigh at site of DTAP or HIB (left thigh) about 4 hours, post vax. According to parents, her entire leg was swollen but had improved by the time we saw her about 1 hour later. The pt was crying but neurologically normal and no fever. Treated with ice and Tylenol. Y 09/19/2001 09/19/2001 0 NONE PVT PUB NONE NONE NONE NC01086 1
0175948 10/02/2001 NC 1.0 1 .0 M 09/24/2001 Pt developed redness, swelling and hives on back and on both thighs. He was treated with Benadryl; given 1 tsp po per the doctor. No SOB. Site was warm to touch. Y 09/24/2001 09/24/2001 0 NONE PVT PUB NONE NONE NC01088 1
0175949 10/02/2001 NC 1.0 1 .0 F 09/24/2001 Red, swollen and warm to touch. Doctor to observe. Y 09/24/2001 09/24/2001 0 NONE PVT PUB NONE NC01087 1
0175950 10/02/2001 OK 4.0 4 M 09/21/2001 Pt's left deltoid to elbow to clavicle is red, swollen, hard, hot and itching. The right deltoid area is red, swollen and hot. Y Y 09/19/2001 09/20/2001 1 PUB PUB Hydroxyzine; Cephalexin given on 9/21/01 Swollen and red~Measles + Mumps + Rubella (no brand name)~1~1.50~In Patient 1
0175951 10/02/2001 CA 2.0 2 .0 F 09/20/2001 Afebrile seizure, 2 days, post vax. 1st seizure. Y 08/27/2001 08/29/2001 2 Pending PVT PVT NONE NONE NONE 1
0175952 10/02/2001 WA 1.2 0 .2 M 09/24/2001 Screaming et leg swollen (L), malaise and upset for over 24 hours. Y 07/31/2001 07/31/2001 0 PVT PUB NONE NONE 1
0175954 10/02/2001 MT 1.0 1 .1 F 07/02/2001 This 12 month old white female went to ER with systemic rash, resembling mumps, over entire body with a fever of 102F, malaise, fatigue, 10 days, post vax of MMR. Y 09/16/1999 09/26/1999 10 PUB PUB NONE NONE NONE MT0116 1
0175955 10/02/2001 WA 5.0 5 F 08/24/2001 Pt had an 11cm X 11.5cm area of redness with inflammation. The area was hot to the touch, hard to the touch and she complained of pain with palpation and with rest. ROM without changes. Afebrile. U 08/22/2001 08/24/2001 2 PUB OTH NONE NONE WA011783 1
0175956 10/02/2001 WA 23.0 23 F 08/29/2001 On 8/22/01, pt developed fever (temperature was not taken). On 8/24/01, she developed a red, blotchy rash. She saw a doctor while visiting in Seattle and was given Tylenol. On 8/27/01, pt had nausea and vomiting and a headache. On 8/28/01, she saw another doctor and had a spinal tap and was dx'd with viral meningitis. On 8/29/01, a follow-up telephone call, she states she is much better. Y Y 08/20/2001 08/22/2001 2 Spinal Tap PUB PUB WA011781 1
0175957 10/02/2001 WA 50.0 5 F 08/20/2001 Pt developed pain, redness and swelling at the site of injected immunization. Too soon to know if recovered. Treated with antibiotics. Y U 08/16/2001 08/17/2001 1 NONE PVT UNK WA011779 1
0175958 10/02/2001 WA 4.0 4 M 08/22/2001 Left shoulder was red, warm and taught, probable MMR and DTP; same site. Rash developed from shoulder to elbow. Pt was given Tylenol 5cc q 4 hours, Benadryl 1/2 tsp q 4 hours and ice to area. U 08/21/2001 08/22/2001 1 PVT PUB Rondec NONE WA011777 1
0175959 10/02/2001 WA 8.0 8 F 09/14/2000 A few hours, post vax, the pt started having symptoms of fever (101.7F), congestion, cough, runny nose, sore throat and anorexia. Also, noted swelling and redness at site. Examined by FNP the next day, who noted a 5cm red, raised area at injection site. Treated with Tylenol. On 9/14/00, call to report possibly a vaccine reaction. Saw the doctor who stated that a few hours, post vax of IPV on 9/12/00, pt came down with a temperature of 101.7F, congestion, cough, stuffy nose, sore throat and lethargy. No vomiting. Anorexia and redness at injection site. Pt had irregular areas "about the size of a quarter" per dad. Seen by doctor on 9/13/00. Per dad, temperature was 101F on 9/14/00 and today on 9/15/00, the temperature is 99.6F with redness at site is beginning to go down per dad but is still at home sick and dad thinks he may be coming down with something now. Asked dad to call if he has further concerns or anything else happens that is unusual. Y Y 09/12/2000 09/12/2000 0 PUB PUB NONE NONE Asthma Swelling, redness and local reaction~Measles + Mumps + Rubella (no brand name)~1~1.25~In Patient WA011776 1
0175960 10/02/2001 WA 36.0 36 F 08/04/2000 About 10 or 11 hours, post vax, pt experienced joint swelling and stiffness in her legs and lower back. She was able to sleep but was awakened about 2 hours later with sharp, shooting pains in her hips and knees and had a fever of 102F. The pain caused nausea and emesis and a sensation of "couldn't sit still". Later she was able to take some Tylenol and slept but this AM her joints are still achy, swollen and tender. She is not able to return to work. N 08/03/2000 08/03/2000 0 PUB OTH NONE WA011775 1
0175961 10/02/2001 WA 4.0 4 M 06/21/2001 Pt developed severe erythema, induration and local itching from elbow to neck on left deltoid. He is using Benadryl, Tylenol and ice packs. Infection was ruled out. He is recovering. U 06/18/2001 06/20/2001 2 PVT OTH NONE NONE Allergic to Augmentin WA011774 1
0175962 10/02/2001 WA 0.75 0 .8 F 06/19/2001 The pt experienced redness and swelling at the site of injection. The reaction started within 1-2 minutes of receiving vax. Treated with cold packs to the site. The pt was monitored for 15 minutes. and the pt's condition had resolved at 75% when they left the clinic. Y 06/19/2001 06/19/2001 0 PVT PUB NONE URI NONE WA011773 1
0175963 10/02/2001 WA 52.0 52 F 07/13/2001 Pt received vaccine on 7/13/01 about 09:00 without incident. At 14:00 on 7/13/01, the pt had a sudden onset of headache, cheeks became red, hot and had a burning sensation. No complaint of difficulty swallowing, no rash or hives, no complaint of increased SOB or wheezing and no chest pain. Y U 07/13/2001 07/13/2001 0 PUB PUB "Heart condition" taking a lot of medications NONE Heart condition WA011772 1
0175964 10/02/2001 WA 17.0 17 F 07/09/2001 The pt's right armpit was swollen and tender to touch and stretching. U 07/05/2001 07/07/2001 2 NONE PUB PUB NONE NONE NONE WA011771 1
0175965 10/02/2001 WA 13.0 13 M 07/13/2001 Mom stated about 10:00 on the same day, pt began hallucinating. This lasted all night and gone by AM. Had same reaction with 1st HBV given 6 months before. Y 02/08/2001 02/08/2001 0 PVT PUB NONE Allergic rhinitis; asthma WA011770 1
0175966 10/02/2001 WA 1.2 1 .2 M 07/10/2001 At 12:30, on 7/10/01, spoke to mother who reported "large red lump" on left leg about the size of a 50 cents piece. The pt had been crying earlier but was walking and playing during phone call. No fever or loss of appetite. Told mother that DTAP and Polio were given on left leg. Apply warm, moist pack X 15 minutes, 3 X a day and give Tylenol for age, if symptoms increase ie fever; leg gets more swollen contact physician. U 07/09/2001 07/10/2001 1 PUB PUB WA011769 1
0175967 10/02/2001 WA 67.0 67 F 08/09/2001 Redness, swelling and warmth at the injection site within 4 hours, post vax. Entire arm was swollen within 8 hours, post vax. Pt stated increased use of Albuterol Inhaler throughout the night. She had joint pain and redness at injection site still present. She went to MD and he prescribed no treatment. Last TD greater than 10 years ago. Y Y 08/02/2001 08/02/2001 0 NONE PUB PVT Albuterol/Atrovent; Serevent; Singulair; Vioxx; Flovent NONE Fibromyalgia; clindamycin, erythromycin and ampicillin allergies WA011768 1
0175968 10/02/2001 LA 37.0 37 F 09/07/2001 One day post vax, the pt noticed 4-5 whelps about 2 inches below the site of vax. The pt came in 2 days post vax to show the health department. The pt was advised to go to her PMD. The pt was diagnosed with allergic reaction and instructed to take Benadryl. The pt also experienced itching around the mouth and ears. Y Y 09/04/2001 09/05/2001 1 NONE PUB PUB Toprol NONE allergy to PCN, SVT LA010902 1
0175969 10/02/2001 PA 4.0 4 M 07/26/2001 Pt developed a large area of swelling on right shoulder and upper arm with erythema. Treated with Motrin and ice. U 09/24/2001 09/25/2001 1 NONE PUB PUB NONE NONE NONE 1
0175970 10/02/2001 OH 1.6 0 .6 M 09/20/2001 On 9/19/01, mother called office with a complaint of rash on both legs of pt and on abdomen. He was afebrile and not acting ill. He was seen at doctor's office by NP and was told it was a reaction to MMR. On 9/20/01, phone call to mother and she said that rash was gone. Y Y 09/18/2001 09/19/2001 1 PUB PUB OH0052 1
0175971 10/02/2001 MS 1.0 1 .0 M 09/26/2001 Pt developed whelps, 3 to 4 hours, post vax, on entire body. Whelps faded but returned in the AM of 9/26/01. Faded by the time of the office visit. Y Y 09/24/2001 09/24/2001 0 PVT PVT Ampicillin causes whelps 1
0175972 10/02/2001 CA 1.0 1 .1 M 09/24/2001 Red, raised, itchy papular plaque at site of injection, 12 days later. Y 09/12/2001 09/24/2001 12 NONE PVT PUB NONE NONE NONE 1
0175973 10/02/2001 RI 1.5 1 .6 M 10/01/2001 Pt developed swelling/redness and was very tender. U 09/28/2001 09/30/2001 2 PVT OTH NONE NONE 1
0175974 10/02/2001 CA 18.0 17 M 09/26/2001 Pt developed swollen and painful joints and hives. Y Y 09/21/2001 09/23/2001 2 OTH PVT NONE NONE 1
0175975 10/02/2001 MA 5.2 4 F 09/29/2001 DTAP was given in left arm above hemangioma. 24 hours, post vax, mom reported swelling and warmth in the arm. Arm measurement was 9" in left arm and right arm was 7 1/2". Y U 09/27/2001 09/28/2001 1 PVT OTH NONE Hemangioma on left arm 1
0175976 10/02/2001 KY 4.0 5 F 08/03/2001 The pt experienced a rash with red bumps which looked like bug bites. The MD saw the pt the following day. The pt had an elevated temp of 102.4. Physician ordered Tylenol and Zovarax liquid. Mother has notified school and day care of exposure. The pt was diagnosed with full blown case of varicella. Y Y 07/31/2001 08/13/2001 13 PUB PUB NONE KY2001066 1
0175977 10/02/2001 KY 2.0 2 .9 F 09/09/2001 2 days post vax, the child broke out in large red welts and hives on face, neck, trunk and arms, legs and back. Seen by MD and was instructed to give Benadryl every 4-6 hours. The pt also experienced slight occasional itching. Y Y 08/28/2001 08/30/2001 2 PUB PUB NONE NONE NONE KY2001067 1
0175978 10/02/2001 NH 10.0 8 F 09/28/2001 The pt was seen in the office with a painful rash on left side of face. There was a cluster of vesicles just in front of ear with a few vesicles scattered along dermatome. Diagnosed with shingles. Y 05/24/2000 09/17/2001 481 PUB UNK 1
0175979 10/02/2001 NJ 5.0 5 M 09/21/2001 The school nurse called and stated the child had chicken pox. She stated that pt broke out with chickenpox lesions which spread from the neck to the arms face and trunk. Lesions were too numerous to count. Some itchiness was noted. Treated with Benadryl and calamine lotion. Y 09/12/2001 09/18/2001 6 NONE PUB PUB PPD / left forearm NONE NONE NJ200117 1
0175980 10/02/2001 WV 4.0 4 M The pt first developed a quarter sized red knot on thigh and then it increased in size with slight swelling. Y Y 09/04/2001 09/05/2001 1 NONE PVT PUB NONE 1
0175981 10/02/2001 GA 6.0 4 M 09/25/2001 The pt experienced itching, painful rash on left shoulder. Lesion cultured for wild strain varicella versus vaccine strain. Treated with acyclovir. Y 04/13/1999 09/24/2001 895 viral culture PUB OTH NONE NONE 1
0175982 10/02/2001 NY 48.0 48 M 09/26/2001 On 9/4/01, received MMR and Mantoux. On 9/16/01, pt complained of severe headache; pain in left leg towards ankle; blood shot eyes and was very dizzy. Went to a doctor. As of 9/27/01, still has severe headache but it does subside towards the end of the day with pain medication. Left leg still throbs. Y N 09/04/2001 09/16/2001 12 NONE PUB PUB PTU-2 tabs 3 X day; Propranolol-1 tab 3 X day; 8/31/01 Mantoux/Aventis Pasteur/U0835AA/ID/LFA/0 previously NONE Hyperthyroidism 1
0175983 10/02/2001 GA 5.0 5 F 09/21/2001 Pt developed chickenpox: varicella rash. Vaccine related. Unknown if any other vaccines were given. Y U 09/17/2001 09/21/2001 4 PUB OTH NONE 1
0175984 10/02/2001 TX 6.0 1 .8 M 09/24/2001 Pt developed chickenpox but none within 24 hours. Progressive rash of papules, vesicles and ulcers, despite vaccination. Recovery is expected. U 08/05/1996 09/24/2001 1876 NONE OTH OTH NONE 1
0175985 10/02/2001 TX 6.0 1 .0 F 09/24/2001 Pt developed chickenpox despite varivax. Typical rash with mild viral syndrome. Recovery is expected. U 04/19/1996 09/23/2001 1983 NONE OTH OTH PPD skin test NONE NONE 1
0175986 10/02/2001 NV 5.0 5 F 09/19/2001 Bilateral rash on upper and lower extremities and torso within 1 1/2 to 2 hours, post vax, (1st time IPV). Reaction is questionable. Pt sent to medical center and they are unsure if reaction to shots and sent pt home. The follow up received on 2/22/02 states resolved within 2 weeks per parent. No further follow up. Y 08/21/2001 08/21/2001 0 NONE PVT OTH NONE NONE NONE NV0110 1
0175987 10/02/2001 GA 23.0 23 F 09/25/2001 Client stated that area around Bandaid turned red Friday afternoon, then by Saturday AM the area was red, hot and swollen. Took Tylenol Saturday at noon. States she got a severe headache Friday night that still exists. Went to ER at 18:30 and was given Benadryl and Solu-Medrol IM. No breathing difficulties. Stated that a bruise appeared Monday around site, 4cm X 2cm. Y U 09/21/2001 09/21/2001 0 PUB OTH 1
0175988 10/02/2001 IL 1.0 1 .7 F 09/25/2001 Mom says pt developed severe swelling in right leg, below the knee, extending to the hip. Sunday she noticed red blotches approx. 3" long and 3" in circumference. Y 09/21/2001 09/22/2001 1 NONE PUB PUB NONE NONE NONE 1
0175989 10/02/2001 MI 40.0 40 M 09/08/2001 Pt developed a rash on medial forearm bilaterally. Hot flash/warm flushed, anxiety and pt states had SOB. O2 100%, IV 0.9 NS and Benadryl. Y Y 09/08/2001 09/08/2001 0 MIL MIL Allegra Hay Fever 1
0175990 10/02/2001 CA 0.3 0 .3 M 09/24/2001 Post vax, last series of vaccines, the pt had crying episodes for 3-4 hours. Y 06/25/2001 06/25/2001 0 PVT PVT NONE NONE NONE 1
0175997 10/03/2001 NY 56.0 56 F 10/01/2001 The patient reported that she received her 1st dose of Lymerix on 03/18/99. She stated, "Within days I began to have terrible pain in my right knee. The pain was accompanied by swelling and heat in my knee. It felt to me like arthritis". The patient stated that she reported her symptoms to her physician on 04/15/99. She reportedly received her 2nd dose of Lymerix on 04/15/99. The knee pain and swelling persisted, and she was referred to another physician, who prescribed physical therapy. The patient reported no relief with physical therapy. The patient reported that she received had 3rd injection of Lymerix on 04/06/00. She stated " My pain and swelling continued to escalate and on 04/22/00, I had arthroscopic surgery on my right knee. [The physician] found that the cartilage in my knee had been destroyed. I went through another course of physical therapy and an extended recovery period but now find that I must have a total knee replacement. In the meantime, I have developed pain in the little finger of my right hand, my right shoulder, my left knee and elbow and both my hips. Life as I knew it was over and my pain has become almost intolerable. I am taking various pain medications and am facing surgery and a long recovery. I believe that my condition has been caused by your product." The patient also stated that she can not sleep "due to the pain". The vaccinee was seen by the vaccine provider on 4/22/99 for follow up on right kneww not feeling better. Onset of the knee problem was not provided. The physician's impression/diagnosis was "right knee pain. rule out meniscal tear." He prescribed Celebrex 200mg twice daily and ordered an x-ray of the knee. The results of the x-ray were not provided. The vaccinee returned to the physician on 4/26/99, reporting "no improvement" in right knee pain. The physician prescribed Relafen 1900mg daily, a knee supportere, and physical therapy. He referred the vaccinee to an orthopedist. On an unspecified date, the vaccinee underwent MRI of the right kneww and a bone scan(results not provided). On 7/26/99, the vaccinee was referred to a neurologist for an unspecified reason. No further mention of the vaccinee's knee, or any orthopedic complaints was made in the vaccine providers office records until 2/24/00. The vaccinee presented to the physician on that date for blood pressure check. Has question about arthroscopic surgery. The vaccinee returned to the physician on 3/9/00 for pre-surgery testing on right knee: the surgical clearance form indicated that the vaccinee was to undergo arthroscopic surgery on the right knee on 4/18/00. The diagnosis on the clearnace form was osteoarthritis. Medications at that time included glucosamine 500mg daily, chondroitin 1000mg daily, Premarin .3mg daily, lisinopril 20mg/Zestroatic 12.5mg one tablet daily, and Norvasc 5mg daily. The physician's impression/diagnosis were recorded in the office note as 1. Hypertension. 2. Right knee pain. The vaccinee returend to the physician on 4/6/00 for blood pressure check. She requested a referral to a chiropractor. She also received the third injetion of Lymerix. The physician's impressions/diagnosis were 1. Right knee pain. 2. OA (osteoarthritis). The next mention of orthopedic complaints was made on 6/6/00, when the vaccinee returned to the physician "for follow up on orthopedic surgery. Patient complains of right and left ankle swelling. They physician's impression/diagnosis were 1. Hypertension. 2. Osteoarthritis. He prescribed NSAID (nonsteroidal anti-inflammatory drug). P.T. (physical therapy). The vaccinee returned to the physician to have her blood pressure checked on 6/30/00. They physicain's diagnosis were 1. Essential hypertension. 2. Edema. 3. Arthralgia. He prescribed a daily multivitamin. The physician saw the vaccinee on 9/22/00. The reason for the visit was recorded as "follow up on increased blood pressure, referall for MRI neck, back, ?. Medications at that time included Lestorestic, Norvasc, Premarin, Neurtontin 300mg daily as needed that had been prescribed by another physician, and ? 10mg daily as needed that had been prescribed by another physician. The physician's impression/diagnosis were 1. Neck/back pains. 2. Hypertension. 3. Knee. On 11/6/00, antinuclear antibody ? and rheumatoid factor were negative. On 12/7/00, the vaccine provider noted that the vaccinee was taking Motrin 800mg daily, Zestoratin, Norvasc, and Premarin. The next mention of orthapedic complaints in the office records was made on 5/25/01, when the vaccines presented to the physician to discuss surgery on knee". The vaccinee reported that she was takin Neurontin 300mg as needed, extended-release diclofenac sodium (Voltaren XR) 100mg as needed, Zestroretic, Norvasc, and Premarin. The physicia's impression/diagnosis were "polyarthritis, osteoarthritis, hypertension". The vaccinee had repeat bloodwork performed on 12/6/01. On 9/13/01, the vaccinee complained of "mild ankle swelling". The vaccinee returned to the physician on 9/20/01 with "both swollen ankles - patient feels good." The ony medications reported by the vaccinee were Zastroretic and Norvasc. The physician's impression/diagnosis were "hypertension, Increased uric acid - ? Gout, increased cholesterol." No futher mention of orthopedic complaints was made in the office notes, which continued to 1/31/02. Medications on 1/31/02 included Zestoretic, Norvasc, Levoxyl 75mg daily, Votaren XR 100mg as needed, Motrin 800mg as needed, Aleve as needed, and Neurontin 300mg as needed. The most recent information received by 5/2/02, did not provde the outcome of the reported events. As of 9/20/01, the vaccinee had swelling of both ankles, but she "feels good". The destroyed" knee cartilage is considered medically serious by the manufacturer. Y N 04/15/1999 04/22/2000 373 Lyme IgM, IgG, and IgA analysis by capture MIA was negative PVT PVT Biaxin, Entex, Zestoretic, Conjugated estrogens, Cefproail, Amlodipine, Multivitamin, Tenoretic, Claritin D, Aspirin, Duratuss, Hydrocholorothiazids, Thyroxine sodium, Ceftibuten Allergy to codeine; appendectomy(1952), hypertension, hypokalemia, hysterectomy(1956), sufla allergy 20010232141 1
0175998 10/03/2001 MN 1.25 1 .2 M 09/27/2001 8 days post vax, the pt experienced a grand mal seizure that lasted 2 hours. ER report states the the vax had no correlation with seizure and was only febrile induced. The pt experienced a high fever and became unresponsive, his eyes were fixed and dilated and he started drooling. He was taken to the hospital. Within 2 miles from home the pt started convulsing. He was totally anesthetized and his breathing was administered with a bag respirator. He experienced developmental delays and was diagnosed with central auditory processing disorder. He can not distinguish who is speaking in a crowd or a classroom. He is under vision, occupational and speech/language therapy. Y Y Y 3 Y Y N 03/06/1996 03/14/1996 8 PVT PVT NONE NONE NONE 1
0175999 10/03/2001 AK 12.0 11 F 12/07/2000 The pt experienced a systemic onset of JRA approximately 2 months post vax. the pt was hospitalized. The pt is currently on steroids and NSAIDS. Y U 08/25/2000 10/01/2000 37 PUB UNK 1
0176000 10/03/2001 TX 0.9 0 .9 M 09/20/2001 The pt experienced a red, swollen area on the left thigh (about half dollar size). The child complained of pain or fever. Heat packs applied every 1-2 hours for 15 minutes for a 24 hour period. Y 09/13/2001 09/14/2001 1 PUB PUB Pulmicort, Cefzil, Albuterol, Atrohist Asthma SA0111 1
0176001 10/03/2001 GA 0.5 0 .5 M 10/02/2001 The pt received vaccines at about 10:15 and by 1:30PM the pt started getting a rash on the side of his face. The following day, the mother states that she noticed the rash all over the infants body. Tylenol was given and Pedicare was also given. U 10/01/2001 10/01/2001 0 PUB OTH Pediacare, Tylenol Cold, runny nose NONE 1
0176002 10/03/2001 MS 3.0 2 1 M 09/21/2001 The pt experienced nausea, vomiting and a seizure on 9/20/01. Y Y 09/19/2001 09/20/2001 1 EEG PUB PUB NONE 1
0176003 10/03/2001 CO 1.25 1 .3 M 09/21/2001 The pt experienced a 3-5 cm hot, red, local reaction to the left lateral thigh. Y 09/11/2001 09/17/2001 6 NONE PUB PUB NONE NONE 1
0176004 10/03/2001 WA 1.0 1 .0 F 09/25/2001 The pt experienced a fever of 102-103 from 9/7/01 through 9/15/01. No other symptoms, seemed prolonged fever. Y Y 09/06/2001 09/07/2001 1 PVT PUB NONE NONE NONE 1
0176005 10/03/2001 TX 0.3 0 .3 M 08/24/2001 The pt experienced a tem to 103.8. Y 08/23/2001 08/24/2001 1 MIL MIL NONE NONE 1
0176006 10/03/2001 CA 1.75 1 .7 F 09/28/2001 The pt developed redness around the injection site and then developed hives on the body with 24 hours. Y U 09/24/2001 09/24/2001 0 NONE PVT PVT viral syndrome NONE 1
0176007 10/03/2001 IL 0.75 0 .8 M 09/21/2001 The pt was vaccinated at 10:30. That evening the pt started having a fever of 101.6 which lasted 48 hours. The pt's fever elevated to 102.2. The pt also experienced loose bowel movements 1 time on 9/12/01. Y Y 09/11/2001 09/11/2001 0 blood culture - neg PVT PVT NONE NONE 1
0176008 10/03/2001 IL 0.2 0 .2 F 09/12/2001 The pt experienced an onset of a fever up to 103.5, which occurred approximately 36 hours post vax. The pt was taken to the ER and was treated with antibiotics for 48 hours and the had improved. Y Y 08/29/2001 08/30/2001 1 UA - nml, CBC - wnl, urine culture - neg, blood culture - neg PVT PVT NONE NONE NONE 1
0176009 10/03/2001 NY 17.0 16 M 10/02/2001 Following a series of 3 vaccines in 8/00. the pt developed bilateral knee pain with effusion. N 08/01/2000 11/01/2000 92 western blot - positive PVT UNK NONE NONE 1
0176010 10/03/2001 WA 32.0 32 M 09/27/2001 The pt was given yellow fever vaccine on 9/25/01 and was presented to health care with 25 cm local reaction at the injection site. Y 09/25/2001 09/26/2001 1 MIL MIL NONE 1
0176011 10/03/2001 GA 32.0 32 F 09/27/2001 The pt experienced localized erythema with swelling at the injection site which was 3" x 3" whish was lymph reported on 9/27/01. Benadryl, ice and warm compressed were used for tratement. Y Y 09/25/2001 09/26/2001 1 MIL MIL Keflex, Naprosyn NONE 1
0176012 10/03/2001 ME 5.0 4 F 10/02/2001 The pt experienced hives, scratchy throat and swelling to the right arm. Y Y 09/28/2001 09/28/2001 0 PVT PUB Singulair asthma ME01037 1
0176013 10/03/2001 KY 0.25 4 M 09/07/2001 The child became sick about 9:00 PM on 9/5/01. She complained of a sore arm with elevated temp to 103. Parents administered Motrin. The pt slept though the night but called the doctor again and was given Motrin. The pts temp went back to 105. Advised to use a cool liquids, popsicles, etc. Y Y 09/06/2001 09/06/2001 0 PUB PUB Denies Denies KY2001069 1
0176015 10/03/2001 WA 1.6 1 .6 M 09/20/2001 The child experienced a swollen left thigh from knee to hip with an onset of swelling. The pt had a good range of motion. Mom reports the child cries at night due to pain and limps when walks. U 09/17/2001 09/17/2001 0 PUB UNK NONE PE tubes WA011782 1
0176016 10/03/2001 LA 1.6 1 .7 F 09/29/2001 Presented with papules, vesicles and pustules over face, trunk and extremities. Dx'd with varicella, post vax. Y U 09/06/2001 09/27/2001 21 NONE PUB OTH UNK UNK Allergic to orange juice 1
0176017 10/03/2001 AZ 1.9 1 .0 F 09/21/2001 Pt developed fever, vomiting and rash X 4 days and a rash appearing today. Pt has moderate injection of the oropharynx and scattered eruption on the cheeks and scattered rash with small blisters over the body, face and ears. Dx: chickenpox. Treat with Calamine lotion and Tylenol. Y Y 11/12/2000 PVT PUB NONE NONE NONE 1
0176018 10/03/2001 NY 79.0 79 F 09/28/2001 The pt returned to the nurses desk where she had been immunized two days prior stating her arm was painful during the night and she noticed redness from the injection site to the elbow. Suggested treatment was analgesics and cold compresses. Y 09/24/2001 09/24/2001 0 NONE PVT OTH NONE NONE 1
0176019 10/03/2001 WA 44.0 44 F 09/26/2001 6 months post vax, the pt experienced whole body flushing, day of vaccine the same day of the vaccine which lasted for 12 hours, with generalized itching for 2 days. Treated self with Benadryl. Y Y 03/14/2001 03/14/2001 0 PUB PUB allergy to food and sulphites 1
0176020 10/03/2001 WA 6.0 6 F 09/11/2001 Pt developed pox at the site of the injection. Y 08/23/2001 08/29/2001 6 PVT PUB NONE NONE NONE 1
0176021 10/03/2001 IN 39.0 39 F 09/24/2001 Pt received Hep-B vaccine on 9/18/01 at 12:30. Pt reported approx. 1 hour later, that she developed a rash on right arm with itching. That evening, she noticed rash on right trunk but it was gone the next day. No other symptoms. Reported on 9/21/01. Reported that she went to donate blood and couldn't because ESR was low. Y 09/18/2001 09/18/2001 0 PVT PVT Kava-Kava; pseudoephedrine Tolectin 1
0176022 10/03/2001 IL 0.4 0 .3 M 09/19/2001 The pt experienced an injection site reaction and abscess to both thighs. N 07/27/2001 08/24/2001 28 PVT PUB NONE NONE 1
0176023 10/03/2001 CA 1.4 1 .4 F 09/27/2001 Localized cellulitis from injection. U 09/25/2001 09/26/2001 1 PUB PUB NONE NONE 1
0176024 10/03/2001 PA 6.0 1 .0 M 09/27/2001 The pt experienced papular lesions which were itchy with abdominal pain. The pt experienced lesions on scalp, face and extremities. The pt was exposed 2 weeks prior to children in classroom. Y 02/08/1996 02/26/2001 1845 NONE PVT PVT TB skin test NONE NONE 1
0176025 10/03/2001 MI 0.5 0 .5 M 09/26/2001 2 hours post vax, the pt got "crabby", began crying inconsolably, had a hard red lump at the injection site. The pt developed a 100.6 fever, had fever the complete next day. By the third day the pt had a fever of 102. Symptoms resolved on Y 09/10/2001 09/10/2001 0 PVT PVT NONE NONE NONE 1
0176026 10/03/2001 CA 4.0 4 M 09/24/2001 The pt came in the office to have a PPD site looked at. It is documented that a 6x7cm erythematous, warm, to the injection site. It started as splotches and then became a confluent area. Y Y 09/21/2001 09/21/2001 0 NONE PVT PVT PPD / connaught cough/cold symptoms and diagnosed with NONE 1
0176027 10/03/2001 MA 1.0 0 1 F 08/07/2001 Pt developed a rash on thigh, neck, chest and arms. A few with crusted centers. Y 05/30/2001 07/17/2001 48 PVT PUB NONE 1
0176028 10/03/2001 CO 1.6 1 .6 M 09/26/2001 The pt experienced a local reaction at the injection site. Y 09/19/2001 09/20/2001 1 NONE PUB PUB NONE NONE NONE 1
0176029 10/03/2001 CA 68.0 U One day post vax, the pt experienced hives all over the body. The pt was treated with Zyrtec. The pt also had trouble swallowing. Following that the pt was then given Prednisolone. Y Y PVT UNK diabetes 1
0176030 10/03/2001 MI 1.0 1 .0 M Onset of fever on 9/21/01 of 100F to 104F with small red spots. Slightly resembling chickenpox on face with onset on 9/24/01. Treatment: observation and Tylenol for fever. U 09/14/2001 09/21/2001 7 PVT OTH 1
0176031 10/03/2001 MA 4.0 4 F 09/20/2001 Pt received IPV and DTAP in left thigh on 9/7/01. Pt was seen in the ER over the weekend. Pt treated for cellulitis. She is on a 10 day course of Keflex. Y Y 09/06/2001 09/08/2001 2 PUB OTH NONE NONE 1
0176032 10/03/2001 WI 3.0 3 F 09/27/2001 Red rash associated with hives over entire body and extremities. Treated with Benadryl elixir. Y 09/25/2001 09/25/2001 0 NONE PVT PUB NONE NONE 1
0176033 10/03/2001 MI 1.6 1 .6 M 09/27/2001 Pt developed left thigh swelling with erythema, warmth and tenderness within 12-24 hours, post vax. Pt was dx'd with cellulitis and given Motrin, warm pads and Keflex. Y Y 09/25/2001 09/26/2001 1 NONE PVT OTH NONE NONE Eczema 1
0176034 10/03/2001 FL 4.0 4 M 09/27/2001 Pt developed swelling, slight hematoma, high fever of 102F and tenderness to right upper deltoid area at DTAP, 24 hours, post vax. Treated with Tylenol and Hydrocortisone creme. Swelling subsided a few hours afterwards. Seen on 9/19/01 and fever like-wise went down. Y 09/17/2001 09/19/2001 2 NONE PUB PUB Photosensitivity; Dermatitis; Allergic Rhinitis Allergic Rhinitis 1
0176035 10/03/2001 PA 5.0 4 M 09/24/2001 Pt developed a 11cm X 12cm red, enlarged, hot area covering entire deltoid of left arm. No RX. Symptoms resolved spontaneously. Y 09/05/2001 09/07/2001 2 PVT OTH NONE 1
0176037 10/04/2001 IN 0.1 0 .1 M 10/01/2001 The pt was presented DOA at the hospital. Cause of death not stated. Y 09/24/2001 N 09/12/2001 09/24/2001 12 NONE PVT PUB Lotrimin diaper rash 1
0176038 10/04/2001 35.0 F A report was received from a health professional on 09/14/01, concerning a 35 year old female patient who was hospitalized due to anaphylaxis after receiving a Fluvirin vaccine on 09/11/01. On 09/11/01, the patient experienced anaphylaxis including redness / itching, difficulty in breathing, and chest pain. 10 minutes after receiving a Fluvirin vaccination. Therapeutic measures taken as a result of this event included Diphenhydramine 50 mg IV and Epinephrine 1:1000, which were administered IV. The patient then became blue, developed red welts on her chest and extreme whiteness of extremities, with no breathing for about 30 seconds. Oxygen was administered and the patient was admitted to the hospital on 09/11/01, with symptoms abating but continuing through. The patient recovered on 09/13/01, and was to be discharged from the hospital on 09/14/01. The reporter has assessed the relationship of the study medication to the event as possible. Y Y U 09/11/2001 09/11/2001 0 UNK UNK Allergy to Sulfa drugs and Metoclopramide. PJP2001002790 1
0176039 10/04/2001 MI 1.25 1 .1 M 09/20/2001 Mom reports toddler got MMR at health dept on 06/22/01 at 4:00 pm. Mom states three days later the child had "hives" all over his body and she took him to the family physician. Mom reports child saw the doctor three times in three weeks and he prescribed Benadryl. After the third episode the child was referred to the pediatrician around 7/09/01. The mom stated the pediatrician stated the child had an allergic reaction to the MMR and he also had an ear - sinus infection. The pediatrician prescribed an antibiotic and Zyrtec. Mom states the child's temperature at the physician's office was 101.5 F. Mom reports while at the local pharmacy for the prescriptions, the child had a seizure. The child's temperature was 103.7 at that time. Mom stated the child was taken by ambulance to the ER, where he had a spinal tap and was in the hospital for 2 days. Mom reports the child still has hives in the mornings and he is on Zyrtec 3/4 tsp on a daily basis. Y Y 2 Y 06/22/2001 06/26/2001 4 PUB PUB 1
0176040 10/04/2001 IL 1.5 1 .5 M 09/27/2001 The patient is an 18 month old who was brought in with episodes of tonoclonic seizures each lasting two minutes. He had three of these episodes in a period of two days. The patient had experienced a minor head injury during play at home. There was no described loss of consciousness at the time. He had seen at the time, i.e. a day prior to hospitalization in the ER and a CAT scan was essentially normal with artifact having been noted. Observed and noted to be stable after three hours and then was discharged home. He was admitted on presentation to the ER following three episodes of seizures. Physical exam showed stable vital signs and unremarkable neurologic exam. There was noted a small contusion in the right infraorbital area. Please see the admitting history and physical for details. Hospital course: the patient was admitted to the acute care unit and monitored. Neurology consultation was obtained and felt that evaluation with MRI and EEG were both normal. Neurosurgical consultation was done and seizure was thought probably idiopathic in origin. Advice by neurology has been to monitor and observe with no intervention and to arrange for further follow-up as an out patient. The patient was noted to have had an episode of vomiting and diarrhea also on admission. Subsequently, had been tolerating diet well with no more vomiting or diarrhea. Hydration status has remained adequate. Discharge condition is stable. Discharge diet regular. Medications none. Activity: regular. Disposition: to follow-up with own pediatrician in one week and with neurology in one month by appointments. Y Y 2 Y 08/23/2001 08/29/2001 6 MRI- Neg. EEG - Wnl. PVT PVT NONE Bilateral crytorchidism - orchiopexy 03/01. 1
0176041 10/04/2001 NY 6.0 6 F 10/01/2001 Local erythema of left deltoid muscle. Y 09/20/2001 09/22/2001 2 PUB PUB NONE 1
0176042 10/04/2001 NC 0.2 0 .2 F 09/25/2001 The infant was inadvertently given 2 doses of Prevnar (instead of 1 dose of HIB and 1 dose of Prevnar). She had a slight "fever" that night, otherwise, no problems. This occurred because the vials for these 2 Wyeth-Lederle products both have the same color of dark blue cap. Y 09/21/2001 09/21/2001 0 OTH PUB Conjunctivitis 1
0176043 10/04/2001 DC 14.0 14 F 10/01/2001 The pt experienced pain at the injection site, followed within 3 hours by severe headache, muscle and joint pain, elevated temperature, fatigue. Symptoms gradually lessened over 72 hour period. Y 09/27/2001 09/27/2001 0 PVT OTH tubersol / connaught NONE NONE 1
0176044 10/04/2001 KY 17.0 17 F 10/02/2001 10 minutes, post vax, the pt complained of itching at the site. The area was red around the injection site. Ice pack was applied and after 5 minutes, the redness spread to her shoulder with a few wheals noted. All vital signs were normal. Treated with Benadryl 50mg, given IM in the right deltoid and signs and symptoms relieved within 5 minutes. Y 10/02/2001 10/02/2001 0 PUB PUB NONE NONE Spina Bifida; Hydrocephalus KY2001072 1
0176045 10/04/2001 CA 15.0 15 M 10/02/2001 Pt felt dizzy, was pale and felt faint. Immunization was given at 15:25 with no treatment needed. Y 08/31/2001 08/31/2001 0 PVT PUB 1
0176046 10/04/2001 TX 1.0 1 .1 M 09/25/2001 Wobbly gait and walking toward his right. This started 2 days, post vax. Also with fever of 101F to 105F. Y 09/18/2001 09/20/2001 2 PVT PVT NONE NONE 1
0176047 10/04/2001 WI 5.0 24 F Pt developed an 8cm X 9cm area of erythema on right deltoid area. Area was warm, red and tender to the touch. U 09/24/2001 PVT PVT NONE 1
0176048 10/04/2001 IL 4.0 4 M On 9/12/01, received DTAP and IPV in the left thigh "IM". On 9/14/2001, pt developed a palm sized warm, swollen and red area at the injection site. Advised HC 1%, ice and Benadryl, 2 tsp every 6 hours. On 9/15/01, the injection site was red, hard and surrounding redness was increasing. Continue present medications and start ibuprofen. On 9/16/01, pt was seen in ER and given Solu-Medrol and Keflex. He had a fever on 9/15/01. On 9/17/01, pt had 25cm X 16cm erythema with vesicles. Pt had a fever on 9/16/01 up to 102.6F. 09/12/2001 09/14/2001 2 UNK UNK 1
0176049 10/04/2001 TX 27.0 27 F 09/28/2001 Pt became dizzy, weak, with nausea/vomiting X 2, runny nose and a sore throat. Oral temperature was 97.8F, heart rate was 92, blood pressure was 122/88 and respirations were 24. Breath sounds were clear and equal. Gave 2 Benadryl and called her doctor and she went to the doctor's office. FNP at doctor's office believes she should not receive #3 Hep-B, but thinks client is coming down with a cold. Y Y 09/27/2001 09/27/2001 0 OTH PUB NONE NONE 1
0176050 10/04/2001 FL 1.4 1 .5 M 09/28/2001 Pt received vaccines at approx. 08:50 on 9/28/01. Pt left 10 minutes later, with no reaction noted. Mother called office at approx. 09:30 and had noted welts all over the pt's body. She came back in, 15 minutes later, and was seen again and given Benadryl and referred to ER. Y U 09/28/2001 09/28/2001 0 PVT PVT Mild eczema Mild eczema 1
0176051 10/05/2001 IN 0.3 0 .3 F 09/24/2001 The pt died of crib death at daycare on 9/18/01. One day post vax. The cause of death was diagnosed as SIDS. Autopsy report confirms cause of death to be SIDS. Death certificate lists cause of death as SIDS also. Y 09/18/2001 N 09/17/2001 09/18/2001 1 PVT PVT NONE NONE IN200119 1
0176054 10/05/2001 NY 13.0 12 M 09/27/2001 Per mother, patient's legs began tingling, he began staggering, couldn't walk. He was taken to the ER and transferred to another ER. Hospitalized for transverse myelitis syndrome. Ongoing. Discharge summary states back pain. msv Y Y 7 Y 07/19/2001 08/10/2001 22 MRI's, Spinal Tap's, X-Ray's, Brain Scans. PVT OTH NONE NONE NONE Discharge summary states spondolosis. msv 1
0176055 10/05/2001 MA 53.0 53 F 09/28/2001 Information has been received from a pharmacist and an approx. 53 year old female consumer who in 3/01 was hospitalized with bacterial pneumonia and bacteremia. While in the hospital, in 3/01, she was vaccinated with 1 dose of pneumococcal vaccine 23 polyvalent. On an unspecified date, the pt developed an injection site with a red mark, 4cm X 5cm and swollen glands. The pt inquired if pneumococcal vaccine 23 polyvalent can cause these problems long-term. The pt sought medical attention and reported her symptoms to the physician. According to the pt, the physician felt that the symptoms "could be due to (vaccination with pneumococcal vaccine 23 polyvalent)". It was reported that her physician is ruling out lymphoma. A biopsy was taken, on an unspecified date, with results pending. The pt was also seen by a dermatologist. At the time of the report, the pt's symptoms persisted. Upon internal review, "rule out lymphoma" was determined to be an "Other Important Medical Event". Additional information has been requested. Y N 03/01/2001 Lymphatic structure (biopsy)-results pending OTH OTH UNK Bacteremia; bacterial pneumonia Penicillin allergy WAES01092609 1
0176058 10/05/2001 NY 19.0 F 10/01/2001 Information has been received from a physician concerning an approx. 19 year old female who was vaccinated with MMRII (lot 635919/0014L) (diluent lot 638152/1779K). Subsequently, the pt experienced severe rhinorrhea, runny and swollen eyes, wheezing and urticaria on her trunk and limbs, about 20 minutes, post vax. She was treated with IM diphenhydramine hydrochloride (Benadryl). Another pt (WAES 01092376) had a similar experience, post vax, with MMRII same lot and diluent numbers. It was noted that the reporter is "uncomfortable using MMR from the same lot". Upon internal review, the pt's experience was considered an "Other Important Medical Event". Additional information has been requested. F/U has been received from a healthcare professioanl indicating that the pt recoverd. She also reported that she did not think the student was positive on her allergies. The records of testing prior to release of this not have been checked and found to be satisfactory. The lot complies with the normal standards of the Center for Biologics Evaluation and Research and was released. Y Y UNK UNK UNK Asthma; shellfish allergy WAES01092710 1
0176060 10/05/2001 IN 1.25 1 .3 M 09/04/2001 The pt experienced a 6-7cm erythematous patch in the left mid thigh. Treated with Keflex for 10 days. Diagnosed as a localized reaction versus cellulitis. Y Y 08/15/2001 08/17/2001 2 PUB PUB NONE NONE NONE 1
0176061 10/05/2001 VA 1.6 1 .6 M 10/03/2001 Hives after 4th DTaP, and 4th Prevnar. N 10/02/2001 10/03/2001 1 NONE PVT OTH NONE NONE NONE 1
0176062 10/05/2001 VT 0.4 0 .4 F 09/30/2001 Pt's left thigh developed slight ecchymosis and induration about quarter-sized with no erythema or cellulitis. Pt is recovering. Y 09/17/2001 09/17/2001 0 PVT OTH NONE NONE NONE Erythema and swelling~Pneumo (Prevnar)~1~0.25~In Patient VT00006 1
0176063 10/05/2001 AZ 0.5 0 .5 F 09/11/2001 Pt was fussy and cried X 6 hours, post vax. This child is 1 of a set of triplets. Y Y 08/17/2001 08/17/2001 0 PVT PVT NONE NONE 1
0176064 10/05/2001 AZ 0.5 0 .5 F 09/11/2001 Pt was fussy and cried X 6 hours, post vax. Pt also had a fever. This child is 1 of a set of triplets. Y Y 08/17/2001 08/17/2001 0 PVT PVT NONE NONE 1
0176065 10/05/2001 KS 0.3 0 .4 F 08/29/2001 Pt immunization card was checked. Child was given immunizations. When mom was given immunization information sheets (VIS) mom said her child should not have gotten Hep-B as she got 1st one at birth and 2nd one on 6/29/01 and the nurse failed to write it into the Pink Immunization. So the 3rd Hep-B given in Hib/Hep (Comvax) at 15:45. Discovered this at 17:50 on 8/29/01. The child had no apparent reaction from this and no evidence seen of reaction after 15 minutes. U 08/29/2001 08/29/2001 0 NONE PVT PVT 1
0176066 10/05/2001 TX 1 .5 F 09/13/2001 Pt started running a fever on 9/10/01 after shot was given. She was given Tylenol and Motrin 1 tsp. Fever had lasted until the present. Y 09/10/2001 09/10/2001 0 PVT PUB NONE 1
0176067 10/05/2001 NY 20.0 F 10/01/2001 A 20 year old female was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live. The patient experienced bronchospasm and laryngospasm almost immediately after vaccination. The paramedics had to be called and the patient received Benadryl injection before symptoms resolved. Another patient had a similar reaction with MMR. It was reported that the physician is "uncomfortable using MMR from the same lot". Upon internal review the patient's experience was considered an other important medical event. F/U states another pt (WAES01092710) had a similar reaction after receiving the same vaccine lot number and dilutent vail. The records of testing prior to the release of this lot have been checked by Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologic Evaluation and Research and was released. Y Y UNK UNK UNK Drug allergy. WAES01092376 1
0176068 10/05/2001 NY 1.0 1 .0 M 08/27/2001 Quarter size redness, fifty cent size swelling, 1 pox. Y 08/14/2001 08/25/2001 11 PVT PVT NONE NONE NONE 1
0176069 10/05/2001 RI 3.0 3 F 09/28/2001 4 days, post vax, pt came to clinic with a large erythema rash on left lateral upper thigh, 6"-7" in diameter. It was hot and swollen at the injection site. Treated with Benadryl and Keflex 250 BID X 10 days. Y Y 09/19/2001 09/21/2001 2 PUB PUB NONE NONE 1
0176070 10/05/2001 PA 0.2 0 .2 M 10/02/2001 Pt developed hives, 3 days, post vax. Y Y 09/20/2001 09/23/2001 3 Evaluation by immunologist PVT OTH NONE NONE 1
0176071 10/05/2001 GA 51.0 51 F 09/29/2001 Pain (severe) and tenderness at injection site. Arm is swollen and tender from elbow to neck. No yet recovered. N 09/26/2001 09/27/2001 1 PUB PVT Ziac 10mg every day NONE NONE 1
0176072 10/05/2001 MO 50.0 50 F 09/27/2001 Pt noticed redness, swelling and soreness last PM. Y 09/26/2001 09/26/2001 0 NONE PVT OTH NONE NONE NONE 1
0176073 10/05/2001 PA 3.5 3 F 10/04/2001 Pt got flu shot on 10/3/01 at 11:00 and then developed a fever of 105F (R) at 03:00. Treated with Motrin and Tylenol and the fever went down to 101F by 08:00. The pt had emesis X 1 at 08:00. A follow up report received 10/10/2001 adds: Child has recovered as of 10/08/01. Y 10/03/2001 10/04/2001 1 PVT PVT Intal MD; Serevent MDI; Flovent MDI; Albuterol Syrup Cough and cold; recovering X 2 weeks RAD; Allergic wheal/flare Rxn to DTAP/IPV at 18 months Wheal/flare~DTaP (no brand name)~4~1.00~In Patient 1
0176074 10/05/2001 AZ 2.0 2 .5 M 09/10/2001 Pt developed erythema and rash. Supportive care and monitor for new symptoms. Follow up: "was not vaccinated at office." Y Y 08/11/2001 08/18/2001 7 OTH OTH 1
0176075 10/05/2001 NY 3.0 3 M 09/11/2001 On 9/11/01, call to MD office from ER. Child being seen for possible seizure activity. The pt had DTAP #4, IPV #3 and Hep-B #1 on 9/9/01. The child shook all over, was pale and tired. No fever. Y U 09/09/2001 09/11/2001 2 Cat Scan of head and blood work were nml. PVT PVT NONE NONE NONE 1
0176076 10/05/2001 WA 4.0 4 M 08/28/2001 Child received DTAP on 8/27/01 in right deltoid, IM, and returned to our office on 8/28/01 with a 3" X 3" redness, swelling and induration over his right deltoid area. He is not yet recovered; here today. Y N 08/27/2001 08/28/2001 1 PVT PUB Albuterol NONE Asthma 1
0176077 10/05/2001 MA 11.0 11 M 09/18/2001 Mother reports child complained of a headache (severe) at approximately 8 PM along with slight irritability. Given Advil with relief of symptom approximately 915 PM. Slept through the night; woke in the AM without complaints. Y 09/17/2001 09/17/2001 0 PUB PUB NONE Possible sensitivity to Hep B preservative. History of migraines. Migraines~Hep B (no brand name)~1~11.00~In Patient 1
0176078 10/05/2001 MA 1.5 1 .5 F 08/27/2001 Child was administered DTaP & IPV on 08/22/01 during WCC concurrent mild pharyngitis, no fevers. On 08/23/01, seizure activity lasting 30-60 seconds, consisting of eyes rolling back, eyes and mouth wide open, unresponsive, no tonic clonic activity. Called 911, brought to the ER, temp 104. Labs: CT head within normal limits, med pharyngitis. Suspect febrile seizure, possible vaccine reaction. Y Y 08/22/2001 08/22/2001 0 Head Ct- Wnl, Glu = 92, Cl = 100, BUN = 14, CR = 0.4, CO> = 23.1, N+ = 134, K = 4.4, lymphs = 26, Segs = 61, Monos = 12. PVT OTH NONE Mild pharyngitis, no fever. Allergic to Ceftin (rash). 1
0176079 10/05/2001 OH M 09/18/2001 Severe local reaction, redness, and swollen from deltoid half way to elbow of the left arm. Treatment: ice and Tylenol. Y 09/12/2001 09/12/2001 0 NONE PUB PUB NONE NONE 1
0176081 10/05/2001 MN 37.0 36 F 08/02/2001 Right after her shot the patient felt flushed and nauseated and lightheaded. @ hours after her shot she felt sharp pains in her head and dizzy. Also had neck pain on the right side (side where shot given) and the skin on the right deltoid became reddened. Some neck / shoulder area x 2 days. Y 07/31/2001 07/31/2001 0 PUB PUB Naproxen, Celexa, Darvocet, Xanox, Deprovera NONE Back pain. Allergies to Codeine and Penicillin. Also said she had a reaction to her Deprovera shot, given in June or May of this year. She felt fatigued, sick, blurry vision, it lasted 1 hour. She had to lay down before going home. 1
0176082 10/05/2001 MN 39.0 39 F 08/28/2001 This patient felt pain in shot area about 1/2 after shot, then he felt light headed. Got a frontal headache and eyes hurt. She then threw up and had a stomach ache. Felt "flu-ish" the rest of the day and "flu-ish" the next day. Missed 1/2 day of work. Y 07/31/2001 07/31/2001 0 NONE PUB PUB Ibuprofen, Prozac, Ultram. NONE Chronic S-1 joint and arthritis, made lung deformity, mild reactive airway disease. 1
0176083 10/05/2001 MN 38.0 38 F 08/28/2001 About 1/2 hour after shot given she felt dizzy and had a headache and got dry heaves with lots of abdominal pain and then she got diarrhea about 2 hours later. Continued with dry heaves. Went home, missed 1 1/2 days of work. Also had some lower back pain day of the shot. Y 07/31/2001 07/31/2001 0 No tests done. PUB PUB NONE NONE NONE 1
0176084 10/05/2001 MT 5.0 5 F 05/23/2001 Mom called on 08/23 in the morning to say her child's leg was swollen to the size of a baseball on the right upper thigh area where she'd gotten 2 injections on 08/21/01. The site per mom's description was large, red, hot to touch and the size of a baseball. The child was complaining it itched and it hurt today. Y 08/21/2001 08/22/2001 1 NONE PUB PUB NONE NONE 1
0176085 10/05/2001 IL 5.0 5 M 09/14/2001 On 09/12/2001 mother contacted this RN per telephone call to report the following: Approximately an hour or two after he received his immunizations on 09/11/2001, he developed dime size or smaller size hives on his back, chest, arms and a couple on his legs with no additional symptoms. His mother contacted an ER who advised the mother to give Benadryl. Mother gave Benadryl, 1 dose about 30 minutes after onset of hives, mother stating hives cleared about 45 minutes after first dose of Benadryl was given. His mother contacted the pt family doctor on 09/12/2001,informing Dr of the previously described information. Dr. advised mother to also notify the Health Department regarding the previously noted information. Y 09/11/2001 09/11/2001 0 UNK PUB 1
0176086 10/05/2001 FL 39.0 39 F 09/17/2001 Two hours after receiving Hep B vaccine headache started then nausea. Headache continued through the next day when vomiting started. Continued for two days, seen by family doctor on 09/07/2001, treated for migraine headache. Told to have Hep B titer drawn before getting third Hep B vaccine. Felt better by Saturday afternoon 09/08/2001. Y Y 09/05/2001 09/05/2001 0 PUB PVT NONE NONE 1
0176087 10/05/2001 CA 4.7 4 M 09/13/2001 Within 1 minute of receiving DTaP, pt had an urticaric induration on right shoulder and right cheek and left shoulder below injection site. There was no wheal. He was given Benadryl 12.5mg po. U 09/13/2001 09/13/2001 0 PVT OTH NONE Sensitivity to Water Babies sunscreen 1
0176088 10/05/2001 TX 12.0 12 M 09/12/2001 Approximately 30 minutes after receiving immunizations, pt returned to clinic with swollen eyes, referred to ER. Y Y 09/11/2001 09/11/2001 0 UNK PUB Asthma and Immutile Cilia Syndrome 1
0176089 10/05/2001 CA 1.33 1 .4 M 09/20/2001 Mild case of varicella. Had Varivax vaccine 5 years ago. Y Y 09/02/1996 09/14/2001 1838 PVT PVT NONE Ingrown Toenail NONE 1
0176090 10/05/2001 CA 0.4 0 .2 M 08/27/2001 2.5 cm in duration central dimpling LT thigh. Y Y 08/09/2001 08/23/2001 14 PVT PVT 1
0176091 10/05/2001 NJ 32.0 32 M 04/22/2001 Chest pain and arm tingling. Y 04/22/2001 04/22/2001 0 NONE MIL MIL NONE NONE NONE 1
0176092 10/05/2001 OK 4.0 4 M 09/27/2001 Left deltoid area swollen, red and hot. Pt was given Amox, Antipyrine/Benzocaine and Hydroxyzine. Y Y 09/24/2001 09/26/2001 2 OTH OTH 1
0176093 10/05/2001 NJ 21.0 21 F 10/02/2001 Upper arm became swollen, red and hot, rash around injection site. Pt refused to see physician, ice applied. Y 09/18/2001 09/19/2001 1 OTH OTH NONE NONE 1
0176094 10/05/2001 WA 29.0 29 F 10/01/2001 Received measles vaccine 09/17/2001. Noted flin like sxs one week later. Two weeks after vaccine developed low grade fever. Currently has maculopupular rash on face, neck and forearms. Y 09/17/2001 10/01/2001 14 PVT PVT NONE Sulfa drugs 1
0176095 10/05/2001 IN 8.0 8 F 09/28/2001 Rash on arm surrounding injection site. Y 05/14/2001 05/15/2001 1 NONE PVT PVT Imipramine and Ritalin Depression and ADHD NONE ~DTaP (Infanrix)~4~8.00~In Sibling 1
0176096 10/05/2001 IN 8.0 8 M 09/28/2001 Rash on arm around injection site. Y 05/14/2001 05/15/2001 1 PVT PVT Clonidine Conduct disorder, inappropriate behavior NONE ~DTaP (Infanrix)~4~8.00~In Sibling 1
0176097 10/05/2001 SC 20.0 20 M 09/28/2001 Client reports redness immediately after injection of Td in left deltoid on 09/21/2001. Redness remains on 09/27/2001. Y 09/21/2001 09/22/2001 1 PPD Left forearm Lot number CD521AA Connaught. PUB PUB NONE NONE 1
0176098 10/05/2001 MT 18.0 18 F 09/20/2001 Pt was at Boyfriend's house the afternoon of 09/20/2001. She fell asleep and then woke up crying approximately 2:30-3am. Stated her left arm felt like "dead weight" was achy and slightly swollen and could barely lift up her arm. Pt has taken Tylenol IHN recommended continue Tylenol and ice intermittently and to call Health Department to see how doing. On 09/24/2001 called patient and she stated arm felt better by Friday evening (09/21/2001). Y 09/20/2001 09/20/2001 0 PUB PVT NONE NONE NONE MT0117 1
0176099 10/05/2001 GA 1.08 1 .1 F 09/30/2001 Varicella onset 09/27/2001. Rx Zovirax, Benadryl PO, topical calamine, fluids and Tylenol. Y Y 11/10/1998 09/27/2001 1052 PVT PUB Rx Augementin SOM/URI OM 1
0176100 10/05/2001 MD 1.5 1 .0 F 10/01/2001 Had MMR and Varivax on 04/03/2001. Developed shingles on 09/27/2001, Rt flank, diagnosed by MD on 10/01/2001. Y U 04/03/2001 09/27/2001 177 PVT PVT NONE NONE 1
0176101 10/05/2001 IN 6.0 6 M 09/13/2001 By evening of 09/11/2001 child tired and not active. Child awoke with 103 degree temperature, hurting, trouble breathing, lethargic and problem swallowing. Only medicine for fever call doc by 9am 09/12/2001. He said due to three shots not properly given in the gluteus maximus caused the reaction. Child also suffered vomiting. Doc Rx Phenegram at over the counter drugs for fever. As of 09/13/2001 at 1 pm the child's fever is controllable and feeling very good. Y U 09/11/2001 09/11/2001 0 NONE PUB PUB NONE NONE NONE 200120 1
0176102 10/05/2001 OH 58.0 58 F 10/04/2001 Began with pea sized swelling of left parotid gland 09/28/2001 which way by 10/01/2001 had progressed to gross swelling of left side of face, low grade temp, headache and neck pain. As of 10/04/2001 swelling and temp have almost resolved HIA "better". Treated with Arigment arophylactically by ENT who saw pt. Y Y 09/12/2001 09/28/2001 16 PVT PVT Cozmar, Estrogen, Indopanide, Xalatin, Betopic, and Acordra. NONE Hypertension, Glaucoma, allergies to strawberries and Macrobid. 1
0176103 10/05/2001 PA 9.0 9 F 09/10/2001 Given third MMR (No documentation of second and needed for school) mother states 5 days later had 4 hour of poor response, headache, stomach ache and legs hurt. Mother states pt has had 2 periods of time at 5 days, one yesterday day 10 after immunization when she had fatigue and aches. Mother concerned about encephalitis. Y 09/10/2001 UNK UNK 1
0176104 10/05/2001 MA 1.5 1 .5 M 09/28/2001 The patient experienced facial redness and swelling with hives on his face, neck, chest, back and arms. The patient was treated with Benadryl. Y Y 09/28/2001 09/28/2001 0 PVT OTH NONE Allergic to amoxicillin, septra and penicillin. 1
0176107 10/08/2001 WI 0.2 0 .2 M 10/04/2001 Apparent SIDS. (Pt had Hep-B/SKB/ENG5208A2/RL/0 on 7/26/01). Autopsy findings confirm cause of death to be SIDS. Y 10/03/2001 N 10/02/2001 10/03/2001 1 Negative autopsy. PVT PVT NONE Cold over the previous week Slight prematurity and low birth weight. 1
0176111 10/08/2001 MS 0.2 0 .2 F 12/10/2002 Hospitalized on 9/22/01 with a dx of meningitis. Results pending. (Pt is a twin). Follow up report received 12/10/02, "Child was diagnosed with brain abcess- (Comatose X 1 mo, Hospitalized X 2 mo) not vaccine related. She gets check - up @ UMC. Is on phenobarbital for seizures. She continued immunization and is current for her age, Y Y 09/21/2001 09/22/2001 1 PUB PUB NONE LBW-Premature MS01043 1
0176112 10/08/2001 MS 0.2 0 .2 F 09/28/2001 Hospitalized 09/22/2001 with diagnosis of meningitis. Y Y 09/21/2001 09/22/2001 1 PUB PUB NONE Premature; LBW MS01042 1
0176113 10/08/2001 AL 0.3 0 .2 F 09/25/2001 On 7/24/01, the pt experienced constant crying, and irritability. On 7/25/01 the pt experienced a fever of 103.3 and was admitted to the hospital following care in the ER. Had blood work done, chest x-ray and spinal tap. All were neg. according to Mom. Symptoms persisted for 4-5 days and then resolved. Mom reports that MD did not know what caused the fever. Y Y Y 07/19/2001 07/24/2001 5 UNK UNK NONE NONE NONE AL0110 1
0176114 10/08/2001 OR 0.2 0 .2 F 09/26/2001 Pt received multiple vaccines at 10:28 AM on 9/25/01 and a dose of Tylenol immediately afterwards. She cried fairly constantly until 18:00 PM. Motrin given 40 minutes before crying stopped. No other signs or symptoms other than tender injection sites. Y 09/25/2001 09/25/2001 0 PVT PUB NONE NONE OR200136 1
0176115 10/08/2001 MS 0.4 0 .4 F 09/12/2001 Pt developed redness, heat and an approx. 40mm raised area to her left upper thigh. Temperature has been taken and grandmother states it has been up to 102F. Temperature was taken by nurse on 9/12/01 at 15:30 and it was 100.2F (Rectally). Grandmother states redness, etc, was not there when infant went to bed, last night. Spoke with the nurse and the doctor instructed to give her 1/4 tsp Benadryl every 4 hours, warm compresses to site, Tylenol for increased temperature. Advised grandmother on this and to take infant to hospital on 9/14/01 if no improvement. Y 09/11/2001 09/12/2001 1 PUB PUB MS01041 1
0176116 10/08/2001 LA 1.0 0 1 F 09/24/2001 Mom noted nickel-sized dimple to left thigh approx. 3 weeks, post vax. Two nurses noted on 9/21/01, left thigh muscle scarring; muscle tissue appears separated. Child referred to doctor for follow-up. U 06/21/2001 07/12/2001 21 OTH OTH NONE LA011001 1
0176117 10/08/2001 NY 50.0 49 F 10/05/2001 Two days, post vax, pt complained of shoulder pain and hip pain which she noticed the morning after vaccines were received. Three days, post vax, on 10/5/01, hip and shoulder pain is unchanged. Injection site is red, hard and swollen. Y 10/02/2001 10/04/2001 2 OTH OTH Plaquenil; Synthroid; Zoloft History of Lupus since 1998 1
0176119 10/08/2001 WY 0.9 0 .8 F 10/02/2001 After receiving DTaP, IPV, & Hep B on 07/11/01, the patient spiked a fever of 103 and was fussy most of the day and throughout the night. When the patient awoke on 07/12/01, the mother felt she had hives that covered her whole body. The patient was taken to the ER. She was given Benadryl. The ER doctor felt hives were unrelated to the vaccines. Benadryl eleviated hives totally within 8 hours. The client had no further fever or symptoms. The patient's pediatrician felt public health should be notified of the reaction. The mother did not report reaction to our office until 09/28/01. Y Y 07/11/2001 07/11/2001 0 NONE PUB PUB NONE NONE NONE 1
0176120 10/08/2001 FL 2.08 1 .1 F 09/27/2001 Varicella vaccine given on 09/06/01. On 09/20/01, papular and vesicular rash right lateral hip at the injection site. No fever, 5 vesicles, 3 papules on the chest Y 09/06/2001 09/20/2001 14 NONE PVT PVT NONE NONE NONE 1
0176121 10/08/2001 MI 1.25 1 .3 M 10/02/2001 Febrile seizure 72 hours post vaccine. Y Y 09/24/2001 09/28/2001 4 PVT UNK NONE 1
0176122 10/08/2001 KY 4.0 4 M 10/02/2001 This child had fever, swelling and redness upper right arm. Taken to the doctor's office later that day vaccines were given. Started on antibiotics. The next day his fever was up to 102, rash all over face and body, right arm was swollen, red, much discomfort. Taken back to the doctor. Today (09/28) right arm still red and swollen, still has faint rash both arms. Advised warm soaks. Y 09/14/2001 09/14/2001 0 PUB PUB NONE MMR, Augmentin (heart murmur). 07/20/1998~Measles + Mumps + Rubella (no brand name)~1~1.30~In Patient KY2001073 1
0176123 10/08/2001 GA 4.0 4 M 09/21/2001 Localized swelling reaction of the right arm above the elbow = soft swelling with erythematous hive. Y Y 09/17/2001 09/19/2001 2 NONE OTH PUB NONE NONE 1
0176125 10/09/2001 4.0 M 10/04/2001 Information was received regarding a 4 year old male who received Acel-Imune, Orimune, and MMR II vaccines on 04/08/98. The child's mother reported that he developed a fever post-vaccination. She also reported that he experienced seizures in his face and body, followed by lethargy. According to his mother the child was diagnosed with temporal lobe damage, and he was unable to walk or talk. She considered the events to be life-threatening and disabling. Merck Sharp & Dohme considered seizures to be medically important. On follow-up, the child's physician indicated that the mother reported that the child experienced headache, mood changes, and behavior changes on 04/11/98. On approximately 04/16/98, the child developed head, mouth, and arm twitching, primarily on his right side. He was losing balance "fully", he had stopped talking, and began staring and drooling. The symptoms reportedly worsened and continued for 1.5 months. The mother reported that the child "acted like a vegetable after 2 months." The child was hospitalized and was noted to be "very combative". The result of an MRI performed in June 1998 was negative, and a "spec scan" showed temporal lobe "involvement". As of 04/30/01, the child was being treated with "Respiritotal" and Depakene (valproic acid). Y Y Y U 04/08/1998 04/18/1998 10 06/00/98 Computerized Tomogram - temporal lobe involvement; Nuclear Magnetic Resonance Imaging - negative. OTH OTH UNK UNK UNK HQ6522628SEP2001 1
0176127 10/09/2001 FL 20.0 20 F 10/03/2001 On 9/20/01, the vaccinee received her 1st IM 20mcg dose of Engerix-B. On 9/25/01, 5 days, post vax, she was admitted to the hospital with abdominal pain, nausea and vomiting. Her liver enzymes (NOS) were "over 1000". A dx of acute hepatitis B was made. The Engerix-B immunization series was discontinued. As of 9/26/01, 1 day after onset, the adverse events had not resolved. Y U 09/20/2001 09/25/2001 5 Liver Enzymes (NOS)-result text: "over 1000" on 9/25/01 OTH OTH NONE UNK 20010231411 1
0176128 10/09/2001 AZ 29.0 29 F 10/05/2001 A couple of minutes, post vax, she came back to Employee Health and said it felt like her throat was swelling. She was taken to ER and given IV with epinephrine Medrol dose-pack; Pepcid; Benadryl and Cortisone. A follow up report received 10/11/2001 adds: Taken to the ER of hospital for evaluation of rapid onset of swelling of the throat after immunization for influenza and 2nd shot in series of Hep B immunization. ER chart states Dx as acute angiodema 2ndary to Hep B vaccine. Y Y 10/04/2001 10/04/2001 0 NONE OTH PVT Singulair; Prozac; Claritin; Coumadin NONE Removal of melanoma and lymph nodes; Pulmonary embolism 1/00 Rash~Hep B (no brand name)~2~21.00~In Patient 1
0176129 10/09/2001 NJ 0.4 0 .4 F 09/17/2001 Pt had 3 shots on 09/14/2001 she developed papular rash around all 3 sites of injection with diffuse local swelling and redness. Advised Benadryl. Y 09/14/2001 09/15/2001 1 PVT PUB NONE NONE NONE 1
0176130 10/09/2001 GA 7.0 0 1 F 10/08/2001 Pt has Chicken Pox. Parent noticed rash on face and trunk last night 10/07/2001. Blisters noted within red "spot". Comfort measurers for itching. Tylenol for fever. Y 07/20/1995 10/07/2001 2271 PVT PVT NONE NONE 1
0176131 10/10/2001 KS M 10/08/2001 A male patient alleges that he received an injection of Flu Shield (1997-1998 Formula) on 01/14/98. Approximately 4 hours post-vaccination, the patient stated that he was "gasping for breath and could hardly walk." He reportedly was seen in an emergency room on 02/20/98 and diagnosed with "double" pneumonia. At that time, the patient reported he was hospitalized and received unspecified treatment. The patient also alleges that as a result of the pneumonia, he has suffered a loss of respiratory capacity requiring daily oxygen use. Y U 01/14/1998 02/20/1998 37 UNK OTH OTH UNK UNK Hypogammaglobulinaemia nos; Lung disorder nos. 6758304 1
0176132 10/10/2001 IL 0.2 0 .2 M 12/14/2001 This report concerns a 2 month old male pt who on 9/4/01 was vaccinated with a dose of haemophilus b conjugate vaccine (+) hepatitis b vaccine recombinant (yeast). Concomitant vaccination, the same day, included a 1st dose of diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid (INFANRIX), a dose of streptococcus pneumonia vaccine (PREVNAR) and a dose of poliovirus vaccine inactivated. On 9/5/01, the pt experienced a "probable, post vax, seizure" and was hospitalized overnight for observation. This was originally reported by an RN. Additional information has been requested. Follow-up info from the registered nurse reported that on 9/5/01 the pt had been napping and according to the pt's mother, he woke up with severe screaming and then arched his back and thrust head backwards. His eyes were open, turned red, his lips and tongue were blue and he was foaming/babbling at the mouth. He ahd a momentary blank stare. The event lasted 30 seconds, then suddenly stopped and then baby continued to sleep. There was no eye deviation and no arm or leg jerking was noted. He was afebrile and did not vomit. The pt's mother called the office 5 minutes later stating that the child was acting normal but sleepy. The baby was seen at the physician's office and was afebrile, sleeping, however awakened easily with his exam, appeared normal and was alert with a good suck. He was then admitted to the hospital for observation. EEG and labs. Upon admission to the hospital, the pt was assessed and he was febrile and his color was pink. His MEENT exam showed normocephaly, normotensive fontanelles and he had positive/positive red reflexes. His tympanic menbranes, nares and throat were clear. His neck was supple without masses or adenopathy. His chest was clear. His cardiovascular exam showed a regular rate and rhythm and normal S1, S2 without S3, S4 or murmur. His abdomen was soft without hepatosplenomegaly, masses or tenderness. His extremities were without deformity. His genitourinary exam reported that he was a normal male, circumcised with bilaterally descended testicles. His skin was without rashes and his tone was normal. The physician's assessment was a probable seizure, post vaccination. Possible breath holding spell. The plan ws to evaluate for any other seizure etiology and observe him for 24 hours with monitoring, EEG and labs. Upon admission, the physician reported that if his labs and EEG were all normal, the physician was "going to presume that this was a mild seizure, secondary to his DTP and would recommend no further pertussis." The pt's EEG, WBC, creatinine, urea, electrolytes and blood glucose level were all normal. The pt was discharged from the hospital on 9/6/01 and subsequently recovered. This was originally reported by a registered nurse. No further info is expected. Y 1 Y 09/04/2001 09/05/2001 1 Electorencephalography-normal (9/5/01); blood glucose-normal; serum blood urea-normal; serum creatinine-normal; serum electrolytes test-normal; WBC count-normal (9/5/01) PVT PVT Prematurity WAES01092063 1
0176137 10/10/2001 TX 3.0 F 12/19/2001 Information has been received from a consumer concerning an approx. 3 year old female who in approx. 2000, was vaccinated with a dose of MMRII. Two weeks, post vax, the pt developed some undefined neurological problems. It was reported that she can not walk or talk, her face is expressionless and she is on tube feedings. It was reported that the pt had tests performed at a hospital. At the time of this report, it was reported that the pt is 5 years old and some days she will wake up and walk normally, but then she regresses. The pt's family believes that the pt's "neurological events" may be due to the Mercury in MMRII. Upon internal medical review, the pt's events; she can not walk, can not talk, her face is expressionless and being on tube feedings were considered "Other Important Medical Events". Additional information has been requested. U 06/25/1997 OTH OTH UNK UNK WAES01092170 1
0176140 10/10/2001 NJ 42.0 40 F 10/02/2001 Pt developed colitis and was hospitalized for a total of 13 days. She was treated with steroids, complicated by systemic joint pain treated with infusions of Remicade. Recurring illness; no cure. Diagnosis -- acute and chronic colitis, moderately severe with ulceration, granulation tissue, cryptitis, crypt abscesses and inflammatory lymphoid infiltrate; iron deficiency anemia; candidiasis, hypokalemia, hypoalbuminemia, hemorrhiods, anal fissure, anorectal ulcerations. Y Y 13 Y N 05/24/1999 12/10/2000 566 PVT PVT NONE NONE 1
0176141 10/10/2001 NJ 62.0 59 M 09/20/2001 Arthritis in many joints increased rapidly since vaccine. Sleep often 2 - 3 times in one day. Tiredness, digestion with abdominal pains, headaches, nervous, etc. Diagnosed with chest pain of unknown etiology. Y Y Y Y 03/01/1999 HLD-DR, DQ Phenotype, antigens present (positive), Neuro path test damage (positive). PVT OTH Univasc 7.5mg twice weekly High blood pressure, arthritis. Mild high blood pressure from previous Lyme but cured of. Got shots to keep from getting it again. Unspecified reaction~Lyme (LYMErix)~3~0.00~In Patient 1
0176142 10/10/2001 CA 0.2 0 .2 M 10/01/2001 The pt experienced hypotonia, perioral cyanosis, temp of 100.4 all within a 24 hour period of vax being given. Y Y 1 Y 09/26/2001 09/26/2001 0 EEG, CBC, UA, Chem 7 PVT PVT Tylenol NONE cows milk intolerance 1
0176143 10/10/2001 TX 0.16 0 .2 F 10/20/2001 The pt experienced a seizure 9 hours post vax. Taken by ambulance to the hospital where a sepsis work up was done. Mother states that the doctor's did not think seizure was caused by vaccines. Y 4 Y 09/24/2001 09/24/2001 0 NONE PUB PUB Tylenol nasal congestion NONE 1
0176144 10/10/2001 MI 1.08 1 .0 M 10/01/2001 the pt's speech completely stopped about 3-4 months after MMR shot because autistic, currently in special education and speech therapy. Y N 07/14/1998 PUB OTH Took Tylenol for fever I believe this was the same time he ran a high fever. fever 1
0176145 10/10/2001 CT 32.0 32 M 09/30/2001 Rheumatoid arthritis, began as wrist and shoulder pain. Also affected hands, elbows, legs and back. Prescribed Prednisone, Arava, Vicodin, Cortisone shots, and NSAIDS Y N 08/23/1999 03/01/2000 191 Lyme disease- Neg. Blood test, x-rays - joint swelling, RA factor - positive. PVT PVT NONE NONE NONE 1
0176146 10/10/2001 PA 40.0 38 M 09/26/2001 Pt's had back pain, joint pain in elbows, hands, wrists and hips when taking medication. I have a reaction in hands and feet (they get red and sore) and also have depression. Y Y 5 Y N 07/24/1999 11/08/1999 107 Blood work for arthritis - Neg. Hepatitis - Neg. MIL MIL NONE NONE Slight L-4, L-5 herniated disc. 1
0176147 10/10/2001 OH 1.0 1 .0 F 09/22/2001 The pt was diagnosed with myoclonic seizures lasting 5 seconds or less in duration. This had a limited duration of 6 week course of seizures with no treatment except B vitamins. Seizures started approximately 5-6 weeks following the MMR vax. Y Y Y 05/08/2000 06/18/2000 41 EEG, lab tests, MRI PVT OTH NONE frequent bouts of bronchitis 1
0176148 10/10/2001 NC 0.2 0 .2 F 09/17/2001 Eight hours post vax, the pt experienced 2 episodes less than 30 seconds each with apnea and cyanosis with a spontaneous resolution. The pt was admitted for observation. Y 1 Y 09/13/2001 09/13/2001 0 Barium swallow - no reflux detected PVT PUB NONE NONE NONE NC01089 1
0176149 10/10/2001 CA 0.3 0 .3 M 09/28/2001 Pt developed a red, blotchy rash, noticed approx. 6-7 hours, post vax. Rash covered back, chest and abdomen in patches with a few small "wheals". Rash slightly worse the next day but improved on the 2nd day, post vax. Y 09/26/2001 09/26/2001 0 PVT PVT NONE Nasal congestion/UR1 plagiocephaly 1
0176150 10/10/2001 ID 0.3 0 .3 F 09/21/2001 Fever - 103, staring episode, constant crying, sleepy, jerky motions in sleep. Y Y 09/13/2001 09/13/2001 0 PVT UNK NONE NONE NONE ID01049 1
0176151 10/10/2001 ID 0.3 0 .4 F 09/12/2001 Fever, shaking of limbs, vomiting, slightly cyanotic, tachycardia, sent to ER. child was examined and released. Y Y 08/23/2001 08/23/2001 0 OTH PVT NONE NONE ID01047 1
0176152 10/10/2001 NC 1.7 1 .7 F 10/03/2001 Fever of 101.7 F noted in the office, also had fever at home, but not documented with a thermometer. Urticaria rash all over the body a day after the immunization were given. Y U 10/02/2001 10/02/2001 0 PVT PVT NONE 1
0176153 10/10/2001 PA 1.0 1 .2 M 10/05/2001 Pt developed a 6 x 4 cm erythematous, warm, tender to touch area on left upper lateral thigh. Pt also developed a papular rash on torso. Pt was treated with compresses and Tylenol and was monitored. Y U 10/01/2001 10/02/2001 1 PVT PUB 1
0176154 10/10/2001 MA 0.2 0 .2 M 09/30/2001 Pt developed inconsolable crying within 24 hours of receiving vaccines which lasted 3-4 hours. Y 09/28/2001 09/29/2001 1 NONE PVT PUB NONE NONE Prematurity at 35 5/7 wks, 2 vessel umbilical cord, mild pelvioectasis right kidney 1
0176155 10/10/2001 MA 0.2 0 .2 M 10/02/2001 Approximately 1/2 hour post vax, pt fell asleep and could not be aroused for approximately 7 hours, from 2-9 PM. Mother reports that pt was also "gray in color." Pt taken to ER and awoke upon arrival. The day post vax, pt was still a little more sleepy than usual. Y Y 09/25/2001 09/25/2001 0 PVT PUB NONE Otitis media NONE 1
0176156 10/10/2001 MI 0.7 0 .6 F 09/30/2001 Day of vaccination, she was very tired, less appetite and low fever. The next day she continued to have a low fever. She was very fussy and cried alot, vomited twice. Two days after the shots she was still out of it (less alert), pale and low appetite. It was finally the third day she was back to herself. Only given her Infant Motrin to handle fever and only Formula for food. Y 09/13/2001 09/14/2001 1 PVT PVT 1
0176157 10/10/2001 NY 0.5 0 .5 M 09/26/2001 Mother reported that 5 days post vax, pt developed a rash on his left thigh which spread to his right thigh. By 9/13/01, the rash had spread to his belly, back, and face. He was seen by MD and a diagnosis of erythema multiforme was made. Y Y 09/06/2001 09/11/2001 5 UNK PVT PVT NONE Mild nasal congestion NONE HQ6380125SEP2001 1
0176158 10/10/2001 PA 1.25 1 .3 F 09/18/2001 Pt developed a short, generalized seizure lasting approximately 15 seconds on 9/17/01. Y Y 09/12/2001 09/17/2001 5 CBC, BMP, UA-all wnl PVT PVT Head banging NONE 1
0176159 10/10/2001 MS 1.2 1 .2 F 10/01/2001 Mom states day after immunization she noted that pt has what she thought was a "diaper rash". it began to spread down her legs and now its on her arms, back and stomach. Mom states pt had fever 09/28/2001 of 101 degrees gave some Tylenol and no further fever. Said temp today at PMW was 97 presented here with note from PCP to look at rash. Rash has some blister looking areas and is worse on lower extremities. Pt still had rash at last visit 10/01/2001. U 09/26/2001 09/27/2001 1 PUB PUB Iron Anemia Bactrim and Trimax MS01044 1
0176160 10/10/2001 GA 1.0 M 10/01/2001 Significant swelling and redness of left upper thigh, high fever 23 May 2001. Resolved on 17 August visit. Y 05/23/2001 MIL MIL 1
0176161 10/10/2001 HI 1.25 1 .3 M 10/02/2001 Eryth macular papular rash at right anterior thigh at injection site by second upper and lower extremities with varicella form rash about 8 to lesions total x4d. Denied ill contact with known chcken pox. Also with ulcers at post pharynx and eryth macules at palms and soles. Consistent with hard foot mouth. Had tactile fever, emeris x 3, presumably sx of Hard Foot Mouth. Unclear if visicles at skin related to hard foot mouth. Seen yesterday 10/01/2001. U 09/25/2001 PVT PVT Advil and Triaminic Multisymptoms Hard Foot Mouth Eczema 1
0176162 10/10/2001 GA 1.0 1 .1 M 09/12/2001 Immunizations were given to child at 10am during his physical appointment at DFACS/FCHD. Mom called clinic at 11:15am saying child's face was swelling, Ref mom to ER for evaluation. Benadryl (oral) and shot. Symptoms: left eye red, red streaks above top lip, right eye swollen shut and jaws swollen. Y Y 09/12/2001 09/12/2001 0 NONE PUB PUB NONE NONE NONE 1
0176163 10/10/2001 CT 41.0 38 F 10/04/2001 Possibly after my first vaccine of 04/1999 but definitely after my second vaccine I developed arthritic symptoms in my fingers, feet, elbows, hips, neck shoulders, spine, wrist and knees. I also became anemic. N 04/02/1999 PVT PVT 1
0176164 10/10/2001 WI 35.0 35 M 10/03/2001 Tremor, sore throat, neck pain and nausea fifteen minutes after administration of vaccine. Treated with 50mg of oral Benadryl. Y 09/21/2001 09/21/2001 0 PVT OTH NONE NONE NONE 1
0176165 10/10/2001 ID 56.0 57 M 09/17/2001 The pt experienced chills, sweating, generalized achiness, loss of appetite, elevated temp. These symptoms started on 9/12/01. The pt reported them on 9/14/01. The pt recovered on 9/17/01. Y 09/05/2001 09/12/2001 7 PUB UNK Claritin NONE NONE ID01048 1
0176166 10/10/2001 CA 36.0 36 M 09/20/2001 On 9/14/01 the pt began with low-grade fever, headache, and myalgias. On 9/15/01 the pt had a fever to at least 101.8 orally, eye pain, anorexia, abdominal cramps, myalgias and diarrhea and a white coating on tongue with peripheral erythema with loss of papillae. Fever abated by 9/16/01 and other symptoms resolved gradually by 9/19/01. Y 09/10/2001 09/14/2001 4 PVT PVT NONE NONE seasonal asthma allergic rhinitis 1
0176167 10/10/2001 NE 25.0 25 M 10/03/2001 The pt received the yellow fever vax on 9/26 and reported to the ER complaining of shortness of breath, flushing, chest tightness and general pruritus. Treated with epinephrine, Solumedrol, Prednisone and then sent home. Y Y 09/26/2001 09/26/2001 0 NONE MIL MIL NONE NONE NONE 1
0176168 10/10/2001 PA 76.0 76 F 09/26/2001 The pt complained of malaise, dizziness, diaphoresis, dyspepsia, cephalgia, extreme fatigue, general myalgia. N 09/19/2001 09/20/2001 1 PVT PVT Zantac, Toprol, EC ASA, Celebrex NONE GERD, obesity, migraine headache, DJD, idiopathic ventricular ectopy 1
0176169 10/10/2001 MN 51.0 51 F 09/30/2001 The pt complained of sore arm from 11/00 through 3/01 and occasionally still sore at the injection site. The pt states that she can no longer reach her right arm across her back and up to her left shoulder. She states she used to be able to do this. A follow up report received 10/12/2001 adds: Pt continues to have diminished range of motion when reaching behind her back to scratch her left shoulder blade. Has not explored with her physician the usefulness of seeing a physical therapist who could suggest range of motion exercises. Pt was reassured that pts do complain after having all type injections. N 11/11/2000 11/11/2000 0 NONE PVT OTH Insulin, Humalog NONE insulin dependent diabetes 1
0176170 10/10/2001 KY 4.0 4 F 10/09/2001 Pt developed less than 50 pox. A sibling, brother, developed less than 50 pox. Had been previously vaccinated about 1 year ago. Y 09/25/2001 10/07/2001 12 NONE PUB PUB NONE Some Pox and Urticaria NONE KY200174 1
0176171 10/10/2001 HI 0.5 0 .6 F 09/25/2001 Pt developed fever the evening immunizations were given. Fever lasted 4 days. Highest temp was 104. Also developed hives 2 days after immunizations. Child was taking antibiotics, Suprox, 100mg daily. Mom took baby to her doctor 2 days later. Mom stopped antibiotic on her own when hives developed. Child diagnosed with left ear infection. Now has a faint, flat rash from hives on abdomen and legs. Y Y 09/19/2001 09/19/2001 0 PUB PUB Suprox 100mg daily discontinued 09/21/2001 UNK Respiratory infection HI0110 1
0176172 10/10/2001 MA 1.5 1 .5 F 09/29/2001 Left arm redness, swelling after immunization given 48 hours ago. Y 09/27/2001 09/28/2001 1 NONE PVT PUB NONE NONE Amoxicillin allergy ~DTaP + Hib (no brand name)~1~1.00~In Sibling 1
0176173 10/10/2001 CA 10.0 10 M 10/01/2001 Five minutes after Hep A injection, child became pale, clammy and passed out. He was wheezing on exam. Rx 97% Epinephrine 0.3 ml, SC, given and albuterol aerosol was administered. Child recovered, wheezing disappeared. BP 86/50; Pulse Ox was 95%. Y 10/01/2001 10/01/2001 0 BP 86/50 Pulse Ox 95 PVT UNK NONE URI NONE 1
0176174 10/10/2001 CA 4.0 4 M 09/30/2001 Left upper arm swollen, red and itchy. Keflex 250mg TIDX 10 days, alternate warm and cold compresses and Benadryl PRN. Y Y 09/28/2001 09/29/2001 1 PVT PVT 1
0176175 10/10/2001 CA 33.0 33 F 09/24/2001 Headache, no appetite, lethargy and abdominal tenderness. Y 01/19/1999 01/20/1999 1 OTH PVT NONE Penicillin and Codeine allergies 1
0176176 10/10/2001 MT 1.7 1 .7 M 09/27/2001 Long arm left shoulder atrophy, had reaction on way home from receiving vax. Mother states the pt had polio vax. Partial sacralization of the right aspect of the L5 vertebral Body. Mild facet sclerosis as well. Normal shoulder other than probable Hill-Sach's defect in the left humerus. The annual follow up states, "All symptoms described previously present." Y N 07/01/1956 07/01/1956 0 PUB OTH UNK NONE NONE MT0118 1
0176178 10/10/2001 WI 25.0 25 F 09/27/2001 Employee reported not feeling well about 60-90 minutes after having TB skin test and Hepatitis B vaccine administered. Skin pale and flushed, complained of weakness, jaw tightness, tingling of extremities, dizziness, respiratory restriction. Employee noted to be hyperventilatory, cool compresses given, allowed to rest, vital signs monitored. Symptoms resolved about 30-45 minutes after start. Employee not noted to have hypersensitivity reaction at injection sites. Employee reports small patch of Y 09/24/2001 09/24/2001 0 Tubersol Mantoux Skin Test Aventis Lot Number C0579AA SC left forearm. OTH OTH UNK NONE Strong sensitivity to psuedopinephrine and dramine. 1
0176179 10/10/2001 MI 4.0 4 F 08/29/2001 Increased fever 102 08/28/2001 pm. Tylenol given, fever reduced. Left arm swelling from shoulder to almost elbow. Hot and soreness mid area of arm a sore with drainage and scab approximately size of a quarter. Seen by PA at Spenser Family Medical Services. Rx Diprolen Cream and Augmentin antibiotics. Pt didn't show up for follow up appointment. Y U 08/27/2001 08/28/2001 1 PUB PUB UNK UNK MI2001075 1
0176180 10/10/2001 MI 12.0 12 M 09/04/2001 Started Sunday 09/02/2001, numerous scattered papular rash, itchy on chest, back, upper and lower extremities. U 08/30/2001 09/02/2001 3 PUB PUB NONE NONE NONE MI2001076 1
0176181 10/10/2001 MI 15.0 15 F 08/28/2001 Dizziness and loss of hearing about 1 month. Observed for 20 minutes. Y 08/28/2001 08/28/2001 0 Pulse taken after 15 minutes at 64-68 BPM RR 16-18/min. PUB PUB NONE NONE NONE MI2001077 1
0176183 10/10/2001 MI 69.0 69 F 09/26/2001 Pt reported itchy, red rash and edema (hives) on upper left arm 5 days after vaccine administration. The rash was reported on 9/17/01. Pt saw MD for assessment on 9/19/01 without further treatment. Pt reported ingesting raspberries on morning rash appeared. Y 09/10/2001 09/15/2001 5 NONE PVT PVT Prempro, Tetracycline, E-String NONE Arrhythmia, NKA 1
0176184 10/10/2001 MI 70.0 70 M 09/26/2001 Reports developing itchy, red rash on buttocks and legs. Five days after vaccine administration. Took Benadryl with moderate relief. Called office 09/17/2001 and rash was assessed by physician 09/19/2001 with no further treatment. Pt ingested raspberries on day rash appeared. Y Y 09/10/2001 09/15/2001 5 NONE PVT PVT ASA NONE Mold and grass allergies 1
0176185 10/10/2001 CA 26.0 25 F 09/28/2001 Pt broke out of rash; and itching left ear inflamed lesions, flushing noted. Benadryl 50 mg 96 given, Benadryl given. Y Y 09/25/2001 09/25/2001 0 PVT PVT NONE NONE NONE 1
0176186 10/10/2001 CA 0.8 0 .8 M 09/26/2001 Scattered multiple small papules, left thigh, mother states similar event happenedwith previous vaccination in both thighs U 09/21/2001 09/22/2001 1 PVT PVT NONE Gormelo untolararec at time foes GE reflex. ~DTP + IPV (no brand name)~3~0.00~In Patient|~Hib (PedvaxHIB)~3~0.50~In Sibling|~DTaP (Tripedia)~3~0.00~In Sibling 1
0176187 10/10/2001 CO 1.2 1 .2 F 10/10/2001 Immunization on 09/17/2001. Fever 104 09/26/2001 decrease to 102 09/28/2001, Temperature 99. Pt has 2 fluid filled vesicles on neck; shoulder, chest and back, has red dots. Cutting teeth now and has had running nose flux with yellow drainage. Y 09/17/2001 09/28/2001 11 PVT PVT 1
0176188 10/10/2001 FL 1.25 1 .3 F 09/26/2001 Pt developed a high fever precipitating seizure 1 week post vax. Y Y 09/13/2001 09/20/2001 7 PVT PVT NONE Neonatal seizures 1
0176189 10/10/2001 WI 2.0 1 .1 M 09/27/2001 In the evening of 3/22/00, pt developed a fever of 105-106. He was lethargic, cranky, fussy and would not walk. During the night of 3/23/00, pt again had a fever of 105-106. On 3/25/00, pt developed rash and vomiting. There was no treatment given that mother remembers. Mother had not reported events to Health Dept previously, but she was called while tracking was being done. These were pt's first immunizations. Y Y 03/22/2000 03/22/2000 0 NONE PUB PUB NONE NONE NONE 1
0176190 10/10/2001 ND 51.0 51 F 07/09/2001 Pt states that since her vaccination, her fingers of the arm receiving the vaccination, have been tingling and today they are more painful. Referred to personal physician for evaluation. Y U 06/13/2001 06/13/2001 0 PUB PVT ND0106 1
0176191 10/10/2001 CA 54.0 54 M 09/25/2001 Two days post vax pt developed diarrhea and vomiting all night. He was better for a few hours. Noon the next day he developed diarrhea and vomiting again that lasted several hours. Y 09/18/2001 09/20/2001 2 NONE PUB PUB NONE NONE CA010104 1
0176192 10/10/2001 GA 2.0 2 .7 F 09/28/2001 Localizer reaction on site of administration of vaccine occurred evening of the day vaccine given. 2c on 10/01/2001. Totally resolved. Y 09/26/2001 09/27/2001 1 PVT PVT mild URI 1
0176193 10/10/2001 IL 0.05 0 .0 M 09/24/2001 On 09/20/2001, 9 days after MMR, patient had a temperature of 103 for 2 days. He then broke out in a rash on his neck and back. Mother did not take him to doctor. Y 09/11/2001 09/20/2001 9 NONE PUB PVT NONE NONE IL01037 1
0176194 10/10/2001 MI 1.2 1 .3 F 10/01/2001 24 hours after DTaP/Hib given. Developed fever for 8 days. Diagnosis with acute otitis media bilateral 7 days within vaccine given. Y Y 09/10/2001 09/11/2001 1 PVT PVT NONE 1
0176195 10/10/2001 NE 39.0 F 09/14/2001 Fatigue, fever (101.9 and 102 on days 9 and 10) begining 7th day after given MMR vaccine. Localized reaction on 4th day after given MMR vaccine. Arm redness, soreness under arm and around shoulder. Rubeola Titer done prior to vaccine, was not immune. PUB PVT TB skin test/Pasteur Connaught/C0521AA/ID/1 previously NONE Hay fever and sensitive to most drugs. 1
0176196 10/10/2001 MA 20.0 0 .3 M 09/25/2001 There is no description of adverse reaction listed. Y 09/18/2001 09/18/2001 0 NONE PUB PUB NONE NONE 1
0176197 10/10/2001 AK 28.0 28 M 09/27/2001 Developed increasing fever and arthritis (starting in ankles and progressing to knees) 3 days after vaccines peaking at 103 at about day 10. Y 09/07/2001 09/10/2001 3 Borderline LFT elevation, decrease in WBC. MIL MIL NONE NONE NONE 1
0176198 10/10/2001 IL 1.0 0 1 F 10/02/2001 Mother called health department. Stated child received varicella and MMR vaccines at doctors office on 09/20/2001. Starting 09/27/2001 or 09/28/2001, child had high fever 102.9. Starting this morning the fever is down, but the child has rash on face "like acne" and trunk like "heat rash". 09/20/2001 09/27/2001 7 PVT UNK NONE 1
0176199 10/10/2001 CA 22.0 23 F 09/24/2001 MMR given 09/14/2001 for negative titer (measles). Pt to employee services 09/17/2001 with complaint of N/V and URI symptoms. Seen in ER 09/19/2001 and dx pregnant (LMP 7101) states she didn't read consent. Follow up with OBGYN. Dr on 09/20/2001 is testing pt for fetal defects. OV to ES 09/24/2001 on medical leave, N and V abdominal cramps continue. Referred back to Dr. U 09/14/2001 09/17/2001 3 09/19/2001 Positive BHCG qualitative (blood) PVT PUB NONE 1
0176200 10/10/2001 NC 11.0 11 M 09/19/2001 Rash, welts, fever and nausea 24 hours after administration of vaccine. Started with flu like symptoms progressing to welts on extremities and trunk. Placed on Prednisone 20 mg PO/q day and increased to 40mg per order Dr. On 09/19/2001, to be titrated down to 5mg over several days time. Return ro clinic if symptoms increase. Y Y 09/14/2001 09/15/2001 1 UNK PUB PUB NONE NC01090 1
0176201 10/10/2001 CO 47.0 47 F 09/26/2001 Four to five cm urticavial lesion on right deltoid two cm below injection site. Treated with ice packs and OTC Benadryl. U 09/17/2001 09/19/2001 2 PVT PVT Lisinopril and Synthroid NONE Hypertension and Hypothyroidism 1
0176202 10/10/2001 CA 4.0 4 F 09/07/2001 Received DTaP left arm 09/05/2001. Indurated area/local Rxn pink and red upper arm within 12 to 21 hours of injection 50% upper forearm affected with edema. Nontender not 5x5 anaphlaxis, temp 100.4 on 09/07/2001 (already swell and red arm by 09/07/2001 vs. 09/05/2001). Cold compresses, Ibuprofen and pre cautioned cellulitis. Y 09/05/2001 09/05/2001 0 NONE PUB UNK Topical Neosporin Blepharitis NONE 1
0176203 10/10/2001 SC 5.0 5 F 08/22/2001 Left arm with swollen area about size of "fifty cent" coin. Middle has hard area. Redness on periphery. Y Y 08/20/2001 08/21/2001 1 NONE PUB PUB NONE Common cold NONE rash~Measles + Mumps + Rubella (MMR II)~~5.00~In Patient SC0146 1
0176204 10/10/2001 SC 2.0 2 .3 F 09/06/2001 No immediate reaction after DTaP on Day 1. Day 2 localized swelling of left thigh, warm to touch, afebrile, no restriction of limb movement, no crying behavior. Day 3, brought to health department by aunt per mom, swelling subsided, to contact private physician. N 09/04/2001 09/05/2001 1 PUB UNK NONE NONE NONE 0143 1
0176205 10/10/2001 SC 15.0 15 M 09/06/2001 Right arm swollen and 4x4 inches diameter of redness. Area warm to touch. Y Y 09/04/2001 09/05/2001 1 PUB PVT SC0145 1
0176206 10/10/2001 HI 1.2 1 .3 F 09/29/2001 Received DTaP/Hib 09/27/2001. Evening of 09/28/2001 immunization site noted to be red, swollen and warm to touch. No pain, fever. Compresses applied. Seen in office 09/29/2001. Symptom improving but chill with 8 X 10 cm area of in duration and erythema. Nontender. Treated symptomatically. Y U 09/27/2001 09/28/2001 1 PVT PVT multivitamin with fluoride NONE 1
0176207 10/10/2001 WI 21.0 21 F 09/27/2001 Immediately following administration of Hep B vaccine, employee passed out, briefly. Monitored and allowed to rest. Resolution of signs and symptoms within 10 minutes. Also reports no po intake prior to vaccinations. No further medical attention received and no further problems reported. Y 07/17/2001 07/17/2001 0 OTH OTH Mantoux/Aventis/C0579AA/SC/LFA NONE Prior history of fainting related to needles. 1
0176208 10/10/2001 CA 45.0 44 F 09/28/2001 Pt developed a temperature over 102 for 36 hrs with frequent chills and a sensation or organs shaking. She had 4 days of bed rest and sleep and 7 days of fatigue. Y 08/06/2001 08/06/2001 0 NONE PUB PVT Paxil 15mg NONE NONE 1
0176209 10/10/2001 IL 1.0 1 .1 F 10/02/2001 Pt presented to the office on 10/2/01 with a diffuse, macular, evanescent rash all over. Y U 09/05/2001 10/01/2001 26 PVT PUB NONE NKA IL01038 1
0176210 10/10/2001 IL 5.0 5 F 09/19/2001 Two days post vax, pt started with diarrhea and low-grade temp of 99.9 with sore throat. On 9/15/01 pt developed hives with the majority of them on her left arm (MMR site). She was seen by MD on 9/16/01 who stated it was from MMR. She was treated with Benadryl po. On 9/17/01 she had a temp of 99, a headache and complained of not feeling well. On 9/18/01 she vomited x 2 and had abdominal pain. On 9/19/01 her hives were disappearing. Y N 09/12/2001 09/14/2001 2 NONE PUB OTH NONE NONE NONE IL01036 1
0176211 10/10/2001 PA 4.0 4 F Prolonged high fever with desquamating rash, joint swelling. Y 08/20/2001 08/30/2001 10 PVT UNK NONE Penicillin allergy 1
0176212 10/10/2001 CA 2.5 2 .5 F 10/02/2001 Really large hard red welts, purple centers. Described by physician as "unusual" lasted 5 days. This was the 4th dose in a series of 5. No previous problems at all. Y Y 07/31/2001 07/31/2001 0 OTH OTH 1
0176213 10/10/2001 GA 4.0 4 M 10/09/2001 Parent reported swelling on 10/7/01. Pt was seen in office on 10/8/01 and was found to have blanchable, red macule which was large over injection site with generalized swelling of middle of right thigh. No treatment was given. U 10/05/2001 10/07/2001 2 NONE PVT OTH NONE NONE 1
0176431 10/10/2001 U 09/28/2001 Two weeks after receiving mumps vaccine, the patient developed mumps virus. No further info is available. U OTH OTH UNK UNK WAES00081945 1
0176432 10/10/2001 PA M 09/28/2001 Information has been received from a pharmacist concerning a male who was accidentally vaccinated with a small amount of mumps virus vaccine live instead of receiving an intradermal sensitivity test. Subsequently, the pt experienced slight redness at the site. Addtl info has been requested. U OTH OTH Skin test antigens UNK WAES00121609 1
0176433 10/10/2001 DE 30.0 F 09/28/2001 Pt received mumps virus vaccine live. Subsequently, the pt had a titer drawn and did not seroconvert. Addtl info has been requested. Y U Diagnostic lab-did not seroconvert OTH OTH UNK UNK WAES01011099 1
0176216 10/11/2001 4.0 F 10/02/2001 A 4 year old white female, with no illness at the time of the vaccination, on 05/07/01 (also reported as 05/09/01) was vaccinated with a 2nd dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live, SC in the right thigh. Concomitant therapy that day included the 5th dose of alum, potassium (+) diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid (Tripedia), administration IM in the left thigh, one dose of tuberculin purified protein derivative, and the fourth dose of poliovirus vaccine (IPOL), SC, in the left thigh. It was noted that the child was being vaccinated for kindergarten. Subsequently, on approximately 05/07/01 (also reported 05/10/01), the patient's left leg in which she received alum, potassium (+) diphtheria toxoid () pertussis vaccine (+) tetanus toxoid and poliovirus vaccinations became hot and swollen. On the next day the patient's symptoms worsened. That morning, on 05/08/01, she had redness and swelling of the left thigh, was seen in urgent care, and was diagnosed with cellulitis. The child was treated with cephalexin (Keflex). It was further reported that on 05/10/01, the cellulitis was resolving. Subsequently, on 05/24/01, the patient recovered. It was also reported that the patient had received one dose of varicella virus vaccine live at one year of age, on approximately 06/27/97 and on approximately 05/17/97 developed chicken pox. Upon internal interview the cellulitis was considered to be an other important medical event. From faxed information "F/U: corrected report: tuberculin purified protein derivative (Tubersol 5 TU) has been injected the same day, 5/7/01. Y Y 05/07/2001 05/07/2001 0 UNK UNK PPD/Tubersol 5 TU/6374330/0149 NONE Sulfa Allergy U2001010300 1
0176219 10/11/2001 SC M 10/09/2001 A mother reported that her 8 month old son received a dose of Rota Shield in 1999. In 6/99, the infant allegedly developed intussusception. It was reported that on 6/15/99, he was hospitalized and required surgical removal of a portion of his bowel. The reporter alleges that as a consequence of the surgery, the infant was permanently damaged. This report of a serious, labeled event, is being submitted in a 15-day time frame, as requested. Y 01/01/1999 01/01/1999 0 UNK OTH OTH UNK UNK UNK HQ6829308OCT2001 1
0176223 10/11/2001 NY 75.0 75 M 10/09/2001 A paramedic reported that her 75 year old father received an injection of Pnu-Imune 23 on 9/10/01. On 9/19/01, he developed shaking chills and a fever. On 9/24/01, he was hospitalized after his fever increased from 101F to 105.5F. He was discharged from the hospital on levofloxacin and as of 10/8/01, the fever persists. Y Y 09/10/2001 09/19/2001 9 Unspecified tests were negative. OTH OTH UNK UNK UNK HQ6866908OCT2001 1
0176224 10/11/2001 FL 0.5 0 .5 M 10/09/2001 A father reported that his six month old son received his 3rd dose of Tetramune along with Engerix-B (SKB) vaccines on 10/27/97. In 10/98, at 18 months of age, the reporter alleges that the child became withdrawn, was unable to speak, was unresponsive to his environment and lost language, motor skills, and affect. The reporter described the child as being "neurologically devastated by the accumulation of Mercury" resulting in permanent neurological injuries and associated learning disabilities. The reporter alleges that these events are caused by the preservative thimersol and "do not arise from the vaccine itself". Info regarding this event has been forwarded to SKB, manufacturer of Engerix-B. Y N 10/27/1997 10/01/1998 339 UNK OTH OTH UNK UNK UNK 6838208 1
0176226 10/11/2001 NY 5.0 F 10/04/2001 A 5 year old female was vaccinated with a 1st dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live. In approximately 1989 the patient experienced leg paralysis. No further info was available. The patient subsequently experienced nausea, fatigue, chills, fever, myalgia, chest constriction, headache and diaphoresis while on therapy with hepatitis b vaccine recombinant. Upon internal review leg paralysis was considered to be other important medical event. F/U information was received from a physician indicating that the pt still has a problem with leg paralysis. She had an ANA blood test done and the results were 1:8. The physician reported that the pt is being referred to a rheumatologist because he thinks that the pt may have some type of rheumatoid problem. Additional information has been requested. At age 17, pt had dyspnea after receiving her 3rd Recombivax HB. Follow up information has been received from a medical assistant indicating that the physician who prescribed the measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) for her sister is deceased and that all of his inactive files, including the patient's records from 1989, has been destroyed. Upon internal review leg paralysis was considered an other important medical event. No further information is expected. U 01/01/1989 Serum ANA-1:8 OTH OTH UNK UNK ~Hep B (Recombivax HB)~~0.00~In Patient WAES01100181 1
0176227 10/11/2001 WI 1.5 1 .5 M 10/03/2001 PT developed paroxysmal changes in his level of consciousness, appearing to fall asleep; events lasting 1-3 seconds. He would then resume his usual activity. This was witnessed by me and the nursing staff. He had 8 episodes in 6 hours, then resolved. No recurrence. Y 1 Y 09/25/2001 09/27/2001 2 Blood counts; blood chemistries-both nml; also, EEG-nml PVT PVT Amoxicillin 150mg TID Otitis Media NONE 1
0176228 10/11/2001 WA 19.0 19 M 10/03/2001 Guillain-Barre' Syndrome. Y Y Y 30 Y Y U 12/01/2000 05/01/2001 151 MIL MIL NONE NONE 1
0176229 10/11/2001 IN 33.0 33 F 10/01/2001 Within one to two weeks after receiving the Flu shot I started to become easily fatigued and progressively weaker. The I started to experience numbness and tingling to my extremities (hands and feet). By December 1999, I got to a point that I was unable to hold up my own body weight without the assist of another person or a stationary object. I began having muscle spasms that started in my legs and progressed up my entire body including my head. I still continue to experience adverse reactions. Y 3 U 10/16/1999 12/28/1999 73 CBC; Sed rate; Electrolytes; Antinuclear antibodies serology; CPK; LP; MRI of head and spine; EMG; Thyroid; SGOT; T3, T4, ALT; Copper test; Anti-thyroid Antibodies-all results nml. OTH OTH Antihistamines, Advil NONE Allergies-Sinus Weakness and fatigue~Influenza (Seasonal) (Fluzone)~1~29.00~In Patient 1
0176230 10/11/2001 MT 3.0 3 F 09/27/2001 Pt started to run fever the night of immunization. Temperature subsided with Tylenol. Pt was given Tylenol at 6:30 AM, and when she was seen in office at 2 PM, her temperature was 102.8 tympanic. Pt had runny nose for 2-3 days prior and was treated with Actifed and Motrin and told to return if fever persisted. Y U 09/25/2001 09/25/2001 0 NONE PVT OTH Runny nose 1
0176231 10/11/2001 AL 1.25 1 .3 F 09/04/2001 The pt began crying around 2 am, which developed into a high pitched scream and squirming around constantly. She had one incident of vomiting around 04:30 AM and a few incidents of diarrhea. He fever ran around 102F until 13:00 PM on the 18th. Her screaming continued off and on throughout the next day. The doctor ordered Motrin and Benadryl. Y Y 08/17/2001 08/18/2001 1 NONE PUB OTH NONE NONE 1
0176232 10/11/2001 OH 0.43 0 .4 F 08/02/2001 On 08/01/2001, mother reports client had fever 100.1 degrees, fussy, not eating, crying at night, reddened area of shot, area of shot swollen to size of 50 cent piece. Tylenol given. On 08/02/2001, mother stopped by health district to report. Advised to call her doctor have her seen. On 09/27/2001, client's mom hasn't returned calls from letters sent 08/02/2001. U 07/31/2001 08/01/2001 1 PUB PUB NONE NONE OH0054 1
0176233 10/11/2001 AL 0.5 0 .5 M 10/05/2001 Pt with acute onset "irritability" less than 1 hour after shot. PE unremarkable except erythema of LE's (anterior aspect only) and consolable by () at exam. Y U 10/05/2001 10/05/2001 0 NONE OTH PVT NONE NONE NONE 1
0176234 10/11/2001 MS 0.75 0 .8 F 10/02/2001 The afternoon after the vaccine, pt had fever, fussiness and diarrhea. Diarrhea lasted 1 week. Follow up visit for diarrhea on 09/14/2001. Pt presented with symptoms ear infection, visited Lumberton Family Health Clinic on 09/22/2001, was given Amoxil 3 times a day for 10 days. Y Y 09/07/2001 09/07/2001 0 PVT PUB NONE NONE NONE ~Measles + Mumps + Rubella (MMR II)~~5.00~In Sibling 1
0176235 10/11/2001 FL 2.0 2 .0 M 10/02/2001 Approximately 10 cm erythema, warm firm lieft upper thigh and right thigh. Treatment: Benadryl liquid, Tylenol and ice. Y Y 10/01/2001 10/02/2001 1 NONE PVT UNK NONE Left OM Chronic OM 1
0176236 10/11/2001 NJ 32.0 31 M 10/03/2001 Shooting pains, elevated temperature, joint pain and stiffness. Three vaccination dates 04/30/1999, 06/05/1999 and 07/07/2001. N 07/07/2001 08/15/2001 39 DNA test for arthritis and Western Blot Lyme Test negative. PVT PVT Alehrex and Vioxx NONE NONE 1
0176237 10/11/2001 CA 42.0 42 M 10/10/2001 The pt experienced rash (hives) everywhere. A follow up report received 10/18/2001 adds: Pt reports he had same day response of blotchy-looking rash which was hot to touch and eventually covered most of his skin. He saw a physician who recommended Benadryl 150 mgs at HS, which he took until 10/16/01. His skin condition has almost cleared. Y 10/03/2001 10/03/2001 0 PVT OTH Zoverax, Lipitor, Chinese herbs AIDS 1
0176238 10/11/2001 IL 64.0 64 M The pt experienced a fever for approximately 24 hours with a headache. Y 10/01/2001 10/02/2001 1 NONE PVT UNK Lipitor elevated cholesterol 1
0176239 10/11/2001 CA 0 .1 M 10/04/2001 Child broke out in hives all over body, vomiting, no fever seven hours after immunization was given. Child was heated in the clinic. Y Y 09/10/2001 09/10/2001 0 NONE OTH OTH UNK NONE NONE 1
0176240 10/11/2001 FL 2.0 M 09/19/2001 After 3 weeks shingles on left inner thighs. Pt seen in ER. PLWH: Impetigo, culture preferred. Treated with Keflex 100mg. Pt's mom instructed to keep area clean, dry and avoid scratching. Follow up in 2 weeks. Y N Culture taken no results as yet. MIL MIL NONE NONE 1
0176241 10/11/2001 OH 13.0 13 M 09/08/2001 Father reported child had seizure like episode lasting several seconds while driving home from clinic. Called clinic and was advised by nurse to go directly to ER. Spoke with father after ER visit. Doctor did not feel he had a seizure and he was determined to be in good health. Y Y 09/08/2001 09/08/2001 0 PUB PUB Denied Denied allergies OH0053 1
0176242 10/11/2001 OH 0.6 0 .2 M 09/25/2001 Grayson screamed for 7 hours after he had his first set of shots. Called doctor and made a check up appointment, said he'd be okay. Tylenol given, but baby extremely fussy. Y Y 05/01/2001 05/01/2001 0 PUB UNK NONE NONE NONE OH0055 1
0176243 10/11/2001 AZ 12.0 12 F 09/28/2001 Urticaria starting 3 hours after receipt of Hepatitis vaccine number 2. Y 09/07/2001 09/17/2001 10 PUB PUB Mild eczema 1
0176244 10/11/2001 ME 77.0 F 10/01/2001 Inflammation, redness, pain progressing over 48 hours. Apparent cellulitis, responding only to IV nafcillin. Y Blood cultures-neg so far PVT PVT Mavic and pTempro NONE 1
0176245 10/11/2001 MI 39.0 39 M 10/05/2001 Right brachial radiculitis with pain on extension, abduction and internal rotation, increased with resistance. Graduated physical therapy and prn ibuprofen. Y N 08/11/2001 08/11/2001 0 Physical examination MIL MIL NONE NONE NONE 1
0176246 10/11/2001 TN 10.0 10 M 10/02/2001 Local dermatitis masculo papular, non-tender, non-puritic, approximately 24 hours after vaccine. Y Y 10/01/2001 10/02/2001 1 PVT OTH NONE NONE NONE same~Hep B (Engerix-B)~1~9.00~In Patient 1
0176247 10/11/2001 ND 12.0 12 M 10/03/2001 Hepatitis B vaccine given 09/26/2001. Local reaction on injecton site, right deltoid from alcohol wipe. Taken to clinic same day, started on antibiotic for ear infection. Body hives developed on 10/03/2001. Has taken same antibiotic before. Y 09/26/2001 10/03/2001 7 OTH PUB Swollen Glands Rubbing alcohol Blisters~Diphtheria Toxoids (no brand name)~3~1.00~In Patient 1
0176248 10/11/2001 WI 11.0 11 M 10/01/2001 Local rash and swelling at injection site. Y U 09/27/2001 09/27/2001 0 UNK UNK 1
0176249 10/11/2001 MA 62.0 62 F 10/04/2001 Pt presented to office complaining of shoulder and neck pain and headache. Exam revealed 4cm erythema surrounding area of immunization, tender to palpation. Treatment: hot packs and NSAIDS. Y Y 10/02/2001 10/02/2001 0 NONE PVT PUB 1
0176250 10/11/2001 NE 4.8 4 F 08/11/2001 Cellulitis at injection site post DTaP. Y 08/08/2001 08/09/2001 1 PVT PVT NONE NONE 1
0176251 10/11/2001 WA 1.5 1 .5 M 10/04/2001 Occur within 24 hours 7 x 9.5 cm area mild in duration peakness and warmth left anterior thigh. This surrounds Hib injection. MMR injection site is a little superior and lateral to this. Given ibuprofen, observe. Y 10/01/2001 10/02/2001 1 PVT PUB NONE NONE 1
0176252 10/11/2001 WI 11.0 11 F 10/03/2001 At 3:30pm, pt not feeling good, ached all over, throat sore, weak and pale. At 2:30am, 102.7 fever. At 3:30am, 102.7 fever. At 3:30am, felt better, dizzy and weak, arm very sore 100.7. Y 10/02/2001 10/02/2001 0 PUB PUB NONE Seasonal Allergies 1
0176253 10/11/2001 IN 56.0 56 F 09/14/2001 On 09/08/2001, swelling and hardness, red and hot to touch at site of injection about the size of an egg. Itched, temp 98.7. To ER given antibiotic, lasted about 3 days. Took Keflex 500mg every 6 hours for 10 days. Y Y 08/31/2001 09/08/2001 8 PUB PUB NONE Had an injury, required stitches. NONE 200123 1
0176254 10/11/2001 IN 0.9 0 .9 M 09/26/2001 On 09/18/2001, mother called and stated child had 2 -3 bumps and redness on left leg at injection site. Also stated child cried 2 - 3 hours. Stated bump are larger, the size of 50 cent piece. On 09/19/2001, mother said she took child to doctor and doctor informed her the child had a reaction to diptherma. Y Y 09/10/2001 09/16/2001 6 NONE PUB PUB NONE NONE NONE ~DTP + Hib (Tetramune)~1~1.00~In Sibling IN200122 1
0176255 10/11/2001 MN 1.4 0 .5 M 10/10/2001 Febrile, seizure on 10/08/2001. Hep B #3 given on 10/08/2001, fever that night, given Tylenol was restless with pains. Noticed legs shaking and eyes rolled back, lasted 1-2 minutes. Y Y 10/08/2001 10/08/2001 0 PVT PVT 1
0176256 10/11/2001 ID 37.0 37 M 08/13/2001 Pt developed GI upset on 7/31/01. Pt had increased temperature and diarrhea on 8/1/01. Pt continues to have severe diarrhea and was referred to physician for evaluation. N 07/26/2001 07/31/2001 5 PUB PVT ID01046 1
0176262 10/12/2001 OR 45.0 45 F 10/05/2001 Information has been received from a health professional concerning a female who on 9/17/01 was vaccinated with an adult 1.0ml 2nd dose of Hep-A virus vaccine inactivated. On 9/20/01, the pt developed an itchy scalp. On 9/21/01, the pt was awakened at 03:00 with a rash and itching on her trunk, extremities and hands. On 9/21/01, sometime in the morning, the pt took diphenhydramine hydrochloride (Benadryl) and her physician directed her to go to urgent care. The pt was placed on 30mg of prednisone and continued on Benadryl. On 9/21/01, the pt noticed that she had nervousness, agitation and difficulty swallowing. On 9/22/01, the pt returned to urgent care and her prednisone was increased to 40mg. Zyrtec was administered orally and camphor + menthol + phenol (SARNA) administered topically was added to her therapy. On 9/23/01, the pt was instructed to take 40mg of prednisone and a "tapering dose" was started. No further information was provided. Upon internal review, the pt's difficulty swallowing was determined to be an "Other Important Medical Event". Additional information has been requested. F/U info states the DOB as 9/22/55 and the pt is 45 years old. F/U info has been received from an NP which indicated that the pt did not report any adverse events with other vaccinations; however, the pt had told her that she had seen an allergist in the past. No information was available regarding the specifics of the pt's visits to the allergist. The reporter stated that she had spoken to the pt since the event and noted that the pt was doing "well". No further information was provided. Y N 09/17/2001 09/20/2001 3 OTH OTH Aspirin; gemfibrozil UNK WAES01100025 1
0176263 10/12/2001 34.0 M 10/09/2001 A 34 year old male received his 3rd dose of Anthrax vaccine on an unknown date. The pt experienced mild tenderness at the injection site with the 1st dose and was diaphoretic, weak and pale with the 2nd dose. On an unknown date, 20 hours, post vax of this 3rd injection of Anthrax, the pt was transported to the ER via paramedics. The pt was administered oxygen 100% via facemask en route to the ER and hydrocortisone 100mg and diphenhydramine 25mg were given IV. He way dyspneic, diaphoretic and pale with urticarial wheals on his face, arms and torso. On arrival, the pt's blood pressure was 124/68 mm Hg, heart rate 48 bpm in a sinus rhythm, respiratory rate 16/min and oral temperature was 96.5F. On exam, the pt's neck was supple, lung auscultation was noted to be clear and the abdomen soft. As his respiratory status improved, the pt was changed to oxygen at 2 L/min via nasal cannula, maintaining oxygen saturations of 98% via pulse oximeter. Within 2 hours, the symptoms resolved and the pt was discharged on prednisone 10mg TID for 2 days, 10mg BID for 2 days and then 10mg daily for 2 days. He was also advised to take diphenhydramine 25mg 1 to 3 times daily, as needed. Follow-up conducted several days later, revealed that the pt developed no additional problems. Y Y Y OTH OTH UNK UNK Diaphoretic, weak and pale~Anthrax (Biothrax)~2~0.00~In Patient BIL010001 1
0176266 10/12/2001 12.0 M 10/04/2001 It is alleged that the aforementioned vaccines were contaminated and adulterated with mercury based thimerosal. It is also alleged that the pt was first diagnosed and discovered to have mercury poisoning and related mental, physical and neurological injuries less than one year from 8/21/01. This was considered to be an "other medical event". No further information is available. U 08/20/1992 01/01/2001 3056 UNK UNK UNK U2001010400 1
0176267 10/12/2001 OK 1.6 1 .6 M 09/21/2001 Pt developed fever on 9/20/01 after vax given. The morning after vax pt's mother reported pt's temp to be 100.4. Pt was given Motrin. Pt also had fussiness, crying, and refusal to walk. Pt was referred to private MD. Y U 09/20/2001 09/20/2001 0 PUB PUB NONE NONE NONE OK0151 1
0176268 10/12/2001 OK 4.0 4 M 09/04/2001 Pt's entire upper arm became inflamed, red and hot to touch. Pt complained of itching in affected area. Y Y 08/29/2001 08/30/2001 1 PVT PUB NONE Allergy to Amoxil OK0145 1
0176269 10/12/2001 NC 11.0 11 M 09/27/2001 On the day of receiving vax, pt's left arm was very swollen to the elbow and hard where he recvd his Hepatitis B shot. At 5 PM that day, pt started feeling very ill, flu-like, with fever, hurting all over and sick to stomach. The next day pt was unable to move and couldn't get out of bed. He was too sick to go to school. Pt stated he had a sore throat. Pt was treated at home with Motrin. On 9/26/01, pt's mother reported that pt's arm was looking better the night before. Upon awakening on 9/26/01, pt could not bend his knuckles and was hurting all over. He was pale and cold early in the AM of 9/26, but the swelling in his arm had improved. Pt reported pain in his teeth, testicles, joints and muscles. Pt seen by MD on 9/26/01, and MD felt pt had a strong, severe reaction to vaccine. On 9/26/01 pt reported feeling very tired. On 9/27/01 pt complained of a headache and stomach ache. Y Y 09/25/2001 09/25/2001 0 NONE OTH PUB NONE NONE Sinusitis arm swelling~Vaccine not specified (no brand name)~~7.00~In Patient 1
0176270 10/12/2001 OK 2.0 2 .1 M 09/21/2001 Mother states, "When child got up this morning his right arm, shoulder, neck and back was swollen and red." No fever reported. 09/20/2001 09/21/2001 1 PUB PUB NONE OK0150 1
0176271 10/12/2001 OK 5.0 5 F 09/14/2001 08/15/2001 onset joint pain wrists, ankles and back pain. Was seen by PMD X 2. 08/30/2001 seen at ER for severe joint pain. Mom reports told could be rheumatoid arthritis or possibly reactive from MMR. Has appointment 09/17/2001 with pediatric Rheumatologist. Mom reports fever "off and on." On moprossyn bid. Y N 08/13/2001 08/15/2001 2 PUB PVT NONE NONE NONE OK0148 1
0176272 10/12/2001 OK 4.0 4 F 08/20/2001 Mom states child's left arm became very swollen and red. Taken to emergency Dept on 08/18/2001. Immunization given on 08/16/2001. Y Y 08/16/2001 08/18/2001 2 PUB PVT NONE NONE Born with birth defect - cleft palate, asthma. OK0149 1
0176273 10/12/2001 OK 5.0 5 M 07/27/2001 Rash; pt given prelone syrup and Benadryl. Rash occurred on face, back, abdomen, legs, was diagnosed in ER with allergic reaction. Mom states she thinks drug due to something in child's room since he broke out with similar drug one day later in same environment. Y Y 07/23/2001 PVT PVT NONE NONE OK0144 1
0176274 10/12/2001 OK 4.0 4 M 08/07/2001 RTC on 08/07/2001. Redness swelling and heat on RD area. Recommended cool compress and pain reliever. RTC if worsen. Y 08/06/2001 08/07/2001 1 PUB OTH NONE OK0140 1
0176275 10/12/2001 OK 1.3 0 .2 M 08/13/2001 Received vaccines about 1:30 pm. By 8 pm developed a rash which looked like a sunburn over his entire torso. By the time Mom took him to the ER he also had blotchy areas on his calves, upper arms, between fingers and behind ears. ER doctor recommended therapy with by mouth Benadryl 1 tsp by mouth three times a day for 5 days. Has low grade subjective fever 08/08/2001. (OK at ER) and 08/09/2001. By 08/10/2001 no fever or rash. Y Y 08/08/2001 08/08/2001 0 PUB PVT Antibiotic finished on 08/05/2001, 08/08/2001 Tylenol before immunize. NONE 07/24/2001 tubes and adenoid 5 mg, 07/27/2001 oral antibiotic drug for complic. OK0142 1
0176276 10/12/2001 OK 1.0 0 .4 F 08/21/2001 Pt developed a high fever of 106F X 3 days. Screamed and cried all day and all night long. She developed a rash 2 days later and then was fine. Gave Tylenol and cool bath. Y 10/03/2000 10/04/2000 1 PUB PVT NONE NONE OK0143 1
0176277 10/12/2001 NY 4.9 4 M 10/15/2001 Pt upper left deltoid was red, swollen and hot; 6cm X 6cm area. Y U 10/04/2001 10/05/2001 1 PVT PVT 1
0176278 10/12/2001 FL 37.0 37 M 09/10/2001 Pt states after receiving HBV #1, he experienced "swelling of neck glands, abdomen pain, lungs shurting, nausea, shoulder, back, arm pain, weakness and blacks spots half dollar size(bruiselike) times 3 on legs, states condition lasted times 2 to 3 days. Y 08/02/2001 08/02/2001 0 PUB PVT NONE NONE NONE 1
0176279 10/12/2001 FL 25.0 25 F 09/06/2001 During vaccine administration pt became rigid then non responsive, eyes fixed, increased saliva from mouth. Responsive after NH4 inhalant used for 45 seconds. Pt monitored for 1 and one half hrs. Pt complained of weakness-no dizziness. Intially slow in response to commands but gradually returned to normal response. Referred to primary care MD for evaluation. Y 08/27/2001 08/27/2001 0 NONE PUB PUB NONE NONE NONE 1
0176280 10/12/2001 CA 44.0 M 10/15/2001 Right arm is swollen 13 cm in diameter with erythema. Pt given single vaccine to right deltoid and buttocks? No fever or pain or limited movement of arm. U NONE PVT UNK NONE NONE NONE 1
0176281 10/12/2001 OK 5.0 5 F 08/22/2001 Pt had raised area of 1 1/2 inches below injection area and a 1 inch lateral from another injection. She complained of area itching, and area slightly warm. Child does not have a temperature. U 08/20/2001 08/21/2001 1 NONE UNK UNK NONE NONE OK0144 1
0176282 10/15/2001 OH 0.2 0 .2 M 10/09/2001 SIDS on 8/18/01. No previous illness. Entirely healthy and normal child. Found dead by childcare personnel. Autopsy reports cause of death as SIDS Y 08/18/2001 N 08/07/2001 08/18/2001 11 Autopsy-SIDS PVT PUB NONE NONE NONE 1
0176283 10/15/2001 LA 0.3 0 .3 M 10/11/2001 Received immunizations on 10/10/01 and presented on 10/11/01 to ER with asystole and was unable to revive. Y 10/11/2001 N 10/10/2001 10/11/2001 1 PVT UNK 1
0176284 10/15/2001 NY 38.0 M 10/08/2001 Information has been received from a doctor of dental science concerning his 38 year old son-in-law who on 9/27/01 was vaccinated with a dose of MMRII. On approx. 9/27/01, the pt developed either an acute and severe asthma attack or an anaphylactic reaction. The pt gave himself a shot of epinephrine and went to the ER where he was treated and released. Upon internal review, acute and severe asthma attack and anaphylactic reaction were determined to be "Other Important Medical Events". Additional information has been requested. Y U 09/27/2001 09/27/2001 0 OTH OTH UNK UNK WAES01100550 1
0176289 10/15/2001 42.0 43 M 10/09/2001 Information has been received from a physician concerning a 42 year old male who on 9/19/01 was vaccinated with the 1st dose of Hep-A virus vaccine inactivated. On 9/25/01, the pt experienced "fever of 103F, chills and headache". A dx of hepatitis was made. The pt sought unspecified medical attention. FOLLOW-UP Information, received 10/12/2001, indicated that the patient was "doing much better", had less jaundice, and his laboratory values had improved. On 10/04/2001 and 10/09/2001, bilirubin was 65 and ALT was 229. respectively. Upon internal review, hepatitis was determined to be an other important medical event. F/U information received on 10/29/01 from a physician indicated that the pt did not have a reaction to Hep-A vaccine. It was reported that the pt started to have some symptoms at the time of vaccination. The physician felt as though the pt was already infected and that the vaccination was coincidental. It was noted that the pt was doing 'well'. The reporter felt hepatitis was not related to therapy with Hep-A vaccine. F/U information indicated that the onset of the pt's symptoms preceded the start of the therapy with Vaqta. Therefore, WAES01100385 is being deleted from our files on Vaqta. Y 09/19/2001 09/25/2001 6 complete blood cell-10/01/01; serum direct bilirubin-04/01-0.2; serum direct bilirubin-10/01/01-10.2; serum alanine-04/?/01; serum alanine-10/01/01;serum alanine-10/09/01-229; serum albumin-10/01/01-WNL;, serum alkaline-04/?/01-97; serum alkaline-10/01/01; serum amylase test-10/01/01-WNL; serum asparate-04/?/01-20; serum asperate 10/01/01-227; serum electrolytes test-10/01/01-WNL; serum gamma glutamyl-10/01/01-1126, serum hepatitis B-04/?/01 (+), serum hepatitis B-04/?/01- (-); serum lipase test-10/01/01-WNL, total serum bilirubin-04/?/01-07, total serum bilirubin-10/01/01-13.9, total serum bilirubin-10/04/01-6.5; total serum protein-10/01/01-WNL; F/U states: 10/4/01 bilirubin-6.5; 10/9/01 ALT-229 OTH OTH UNK Anti-hepatitis B virus antibody positive. WAES01100385 1
0176293 10/15/2001 MD 1.0 1 .0 F 09/28/2001 Arrived at the ER unresponsive and possibly a seizure at home. Child was intubated and given Propoful. Given Ativan, and Dilantin. Transferred to WVU. Once at WVU, febrile 102.7. Febrile seizure was the diagnosis. Y Y Y 3 Y 09/24/2001 09/25/2001 1 Spinal Tap, Blood and urine culture = Neg. PVT PUB NONE NONE NONE 1
0176294 10/15/2001 VA 1.0 1 .0 M 10/08/2001 On day 9 after vaccinations the infant had complex febrile seizure given valium 2 times, no barb, intubated for ^5 hours in the PICU. He had a high fever (>104). He had cold symptoms for ^3 weeks, which seemed to worsen the day before the seizure. Y 1 Y 09/26/2001 10/05/2001 9 Normal Head CT scan, Normal EEG (with diffuse slowing attributed to anticonvulsants). Normal CBC (WBC 8k), Neg blood & CSF cx (normal CSF fluid). PVT PVT NONE URI X 2 weeks Possible tomato allergy; hives 1
0176295 10/15/2001 WV 0.3 0 .4 M 10/09/2001 Temperature of 103 the night the IZ's were given. Fever persisted 24-72 hrs. Redness and swelling at right thigh injection site. Y 08/15/2001 08/15/2001 0 NONE UNK UNK NONE Wolf Parkinson White Syndrome 1
0176296 10/15/2001 PA 0.2 0 .2 M 10/05/2001 Fever of 101, grunting respiration, mild retractions associated with a distant look, not focusing well with increased drooling and inability to nurse. Lasted around 45 minutes to 1 hour, then completely resolved. Possibility of seizure based on Mom's description. Y Y 08/24/2001 08/25/2001 1 NONE PVT PVT NONE NONE 1
0176297 10/15/2001 PA 1.75 1 .0 M 10/02/2001 Developed lesion on arms, face and chest. Y 02/12/2001 09/05/2001 205 NONE PVT PUB NONE NONE NONE 1
0176298 10/15/2001 NC 1.5 1 .6 M 10/04/2001 Left thigh has 11 X 14 cm redness and warmth. It was a local reaction. Treatment was cool compresses and Tylenol or Ibuprofen. Y Y 10/02/2001 10/02/2001 0 NONE PVT PUB NONE NONE NONE NC01092 1
0176299 10/15/2001 MT 0.9 0 .9 F 10/09/2001 Parents phoned late on 10/05/01 and stated child had hives and rash. No other adverse effects. Dr talked with parents and instructed to see a physician in ER or see him if symptoms worsened. Y 10/04/2001 10/05/2001 1 PVT UNK 1
0176300 10/15/2001 PA 61.0 59 F 10/08/2001 Diagnosed with Lymes disease in 1998. Asymptomatic until 2/21/00. Third Lymes vaccine received 2/17/00. On 2/21/00 presented with sx of pain upper right arm muscle, lethargic, head pressure and cognitive impairment. On 5/00 presented with bronchial cough. 6/9/00 presented with dizziness. On 7/3/00 was still dizzy. Diagnosed by ENT specialist with benign paroxysmal postural vertigo. On 10/7/00 presented with cold sx and sinus and ear infections and pain in right upper arm. Still suffering from diminished concentration and cognitive functions and lethargic and head pressure. From 10/19/00 to 3/21/01 still had the same sx and was referred to allergist. On 04/19/01 presented with pain in upper arm radiating to neck, shoulder and clavicle, occasional heart flutter, head pressure and cognitive impairment. On 7/16/01 had diarrhea. On 8/06/01 to 8/09/01 while reading letters ran togather and her entire body felt like it was vibrating. Became bedridden. Symptoms gradually subsided with stiff neck and head pressure and lethargy. N 02/17/2000 02/21/2000 4 Tested for Lupus on on 4/3/00 and results were negative. On 4/27/00 cat scan of sinuses and results were negative. On 04/03/01 and04/17/01 had allergy testing and was treated for allergies. On 04/24/01 had MRI of right arm and cervical spine. Referred for x-rays of right shoulder and cervical spine. The MRI scans show degenerative disc disease in cervical spine with osteophytosis and disc bulging She also has a full thickness tear of the supraspinatus tendon with some degree of retraction. On 05/07/01 had EMG done. Had stool specimen done and Giardia positive and treated. Blood test for HLA-DR4+ results were positive. PVT OTH Ceflacor, Doxycycline, Z packs, Mechlazine, Suprax, Zithromax, Augmentin, Amoxicillin, Prednisone, Allegra, Astelin, Metronidazole,Tylenol with codeine, Levoxyl, Humibid, Prempro NONE Had nephrectomy and Hashimoto's thyroiditis 1
0176301 10/15/2001 CA 41.0 41 F 10/09/2001 Pt's left deltoid became extremely swollen to the size of an adult fist. It was erythematous and very tender. It responded to ice. Y 10/03/2001 10/03/2001 0 NONE OTH PUB NONE Asthmatic 1
0176302 10/15/2001 TX 27.0 27 F 10/05/2001 Pt developed hives and wheezing. Treated with Benadryl and epinephrine and called EMS for transport to ER. A follow up report received 10/22/2001 adds: Reporter reports almost immediate onset of hives, wheezing after series of injections. Have been giving same shots except new lot of Flu vaccine. Pt denied egg sensitivity. Pt had no record of previous injections in previous 4 weeks. Treated and released from base ER. Y Y 10/05/2001 10/05/2001 0 MIL MIL NONE NONE Allergy to red dye, lobster and oranges. 1
0176303 10/15/2001 TX 19.0 19 F 10/05/2001 Pt developed hives and wheezing and required Benadryl and epinephrine. EMS was called for transport to ER. A follow up report received 10/22/2001 adds: Reporter reports almost immediate onset of hives, wheezing after series of injections. Have been giving same shots except new lot of Flu vaccine. Pt denied egg sensitivity. Pt received IPPD at same time as other injections. Pt had no record of previous injections in previous 4 weeks. Treated and released from base ER. Y Y 10/05/2001 10/05/2001 0 MIL MIL PPD/Aventis/C063AA/LFA NONE NONE 1
0176304 10/15/2001 TX 1.2 1 .2 F 08/21/2001 05/07/2001 Shots given, 05/15/2001 Fever, 05/24/2001 Cough shots given, 05/29/2001 Fever 101.7 cough and wheezing, 5/30/2001 Sore throat, wheezing, fever, 06/01/2001 Fever, sore throat, neck and weazing 103, 06/04/2001 Skin rash. On 6/5/01, dx'd with a viral syndrome and exanthem. Had diarrhea and shoddy lymphadema. Y Y 05/24/2001 05/27/2001 3 CBC; UA PVT PVT Cough Allergy to Zyrtec 05/15/2001~Measles + Mumps + Rubella (MMR I)~~1.00~In Patient 1
0176305 10/15/2001 TN 4.0 4 M 09/11/2001 About 10:30PM 8/22/01 the mother noted swelling at the injection sites in left deltoid. the pt complained of itching. Mother took him to ER immediately where he was Rx'd with 12.5 mg of Benadryl Elixir po and given 10 cc to take 1 tsp every 4-6 hrs as needed. Y Y 08/21/2001 08/22/2001 1 PUB PUB NONE NONE NONE TN01047 1
0176306 10/15/2001 TN 2.0 2 .4 M 09/21/2001 On 09/20/01 HD MD -Left upper arm swollen almost to 2 X normal size from elbow to shoulder with some swelling above shoulder. In the area of the injection there is increased erythema and multiple tiny vesicles. Instructed to go to PCP today. Mother states they went to ER and 3 different doctors looked at child without knowing the problem. Chest x-ray and CBC done. Pt prescribed oral antibiotics and topical ointment for arm. Y Y 09/18/2001 09/20/2001 2 Chest x-ray and CBC done with increased CBC. JMGGH FB 09/20/01 PUB OTH NONE NONE NONE TN01048 1
0176307 10/15/2001 TN 4.0 4 F 09/21/2001 Mother states Kolbie's arm (site) swelled to the size of the palm of a hand. MD looked at child's arm in ER while brother being seen. Mother says MD stated it was swelled larger than usual but ok. No meds prescribed. Y 09/18/2001 09/20/2001 2 NONE PUB OTH NONE NONE NONE TN01049 1
0176308 10/15/2001 PA 49.0 49 F 10/03/2001 Rash, hives head, to toe, seen ER and given Benadryl shot and additional and over counter 50 mg to be used. Y Y 10/01/2001 10/02/2001 1 PVT OTH 1
0176309 10/15/2001 VA 0.4 0 .1 F 09/10/2001 Fever 102 prolonged crying for 24 hours. Physicians recommended only DT for follow up doses. Y Y 07/16/2001 07/16/2001 0 PUB PVT NONE NONE VA01028 1
0176310 10/15/2001 NC 75.0 75 F 10/02/2001 RVA given pneumonia on 10/02/2001, localized irritation noted right arm, warm to touch, swollen and tender, hard chills on 10/01/2001. To see PMD 10/02/2001. Y 10/01/2001 10/01/2001 0 PUB UNK Vi Ox, synthroid, lithium, viesta Arthritis, Fibromyalgia. NC01091 1
0176311 10/15/2001 MD 3.3 3 F Pt developed erythema and swollen area around vaccine site. U 10/09/2001 10/09/2001 0 PVT UNK Cellutitis HGSC Sickle Cell Disease 1
0176312 10/15/2001 IA 3.0 3 M 09/29/2001 High fever (102) beginning 6 hours after vaccination and continuing for 2 days. Also some lethargy. I know it was a result of the vaccine, because the vaccination was given during a well-child check-up. There were no other symptoms. Y 09/06/2001 09/06/2001 0 PVT OTH NONE NONE NONE 1
0176313 10/15/2001 CT 4.0 4 M 10/08/2001 DTAP in left arm muscle, had swelling of entire left arm extending to anterior left chest within 24 hours of shot. Treated with Augmentin for possible cellulitis. Resolved within 5 days. Y Y 09/17/2001 09/18/2001 1 PVT PVT Claritin Seasonal allergies 1
0176314 10/15/2001 IA 14.0 14 F 10/08/2001 10/04/2001 and 10/05/2001, headache, fever. I took her to Dr. He thought it was a reaction to the shot. He will send information to you. He said she would need to take medication for 3 days before the next shot. Y Y 10/03/2001 10/04/2001 1 PUB PVT IA01013 1
0176315 10/15/2001 KY 1.0 0 .0 M 09/28/2001 Mom called HD 09/27/2001, stated child has blister like formation over both legs and abdomen which appear to be chickenpox, phone call to Mom 09/28/01, states started having fever 103 at 1700 hours, same day of son's X's 4 days took to PMD 09/13/2001 causes to states better today places are dried. Y Y 09/10/2001 09/10/2001 0 PVT PVT NONE NONE NONE KY2001075 1
0176316 10/15/2001 GA 5.0 0 1 M 10/12/2001 Rash on back, 10 to 15 small erythematous papules on back most crusted, a few vesicles, 10/11/2001. Medication: Benadryl by mouth as occasion requires return to clinic if rash increases. Y Y 04/04/1997 10/10/2001 1650 PVT PVT 1
0176317 10/15/2001 OH 5.0 5 F 10/11/2001 MMR #2, given 10/05/2001 s/q arm. Y Y 10/05/2001 10/09/2001 4 PUB PVT 1
0176318 10/15/2001 OH 4.0 4 M 10/11/2001 On 10/05/2001, Pt received MMR #2. On 10/06/2001 pt went to OHER. Left arm swollen, red and warm from shoulder to elbow. Child put on antibiotic, ER doctor ask pt mom to call us. Mom was called 10/10/2001. better. Arm decreased in size. Y Y 10/05/2001 10/06/2001 1 PUB PVT NONE Hi Sag & mom 1
0176319 10/16/2001 WI 0.2 0 .2 F 10/08/2001 On 10/07/01, pt died. Possibly SIDS. COD as per autopsy report -- SIDS Y 10/07/2001 N 10/01/2001 10/07/2001 6 NONE PVT PUB NONE NONE 1
0176322 10/16/2001 AL 1.25 0 .3 M 07/26/2001 On the day after immunizations, 7/20/01, the child was acting normal until early afternoon, when he developed nosebleed and then difficulty breathing which he then progressed to respiratory failure requiring intubation and mechanical ventilation X 2 days. Seizure was suspected by some MD's but not confirmed. Had a similar previous episode on 4/23/01 not associated with vaccine. The full extent of developmental recovery is unknown. Y Y Y 10 Y 07/19/2001 07/20/2001 1 EEG on 7/20/01-nml PVT PUB Tylenol NONE Neuronal migration disorder, developmental delay 1
0176323 10/16/2001 IN 0.3 0 .3 M 10/05/2001 16 hours, post vax, pt had a 20 minute seizure followed by about 15 minutes of post- ictal state and then a 30 second seizure. Both tonic/clonic grand mal. Afebrile both tactile and highest ER temperature was 99.7F. Had received DTAP, IPV, HIB-Hep-B, Prevnar on 8/2/01 without incident. Y 1 Y 10/04/2001 10/05/2001 1 EEG (after seizure)-neg; MRI-neg; Blood culture (-); CSF culture-(-) PVT PVT NONE NONE Mild colic 1
0176324 10/16/2001 LA 4.0 4 F 10/08/2001 On 8/9/01, pt complained of throat hurting. Temperature was 103F on Thursday, Friday and Saturday. Rx'd with Tylenol and on Sunday had more rash and fever. Treated with Tylenol and Benadryl. Feet had been hurting X 2 days. Rash on abdomen and developed edema of feet. Went to ER. States rash, by this time, looked like blood blisters. Rash to waist and hands. IV antibiotics and steroids given. In 24 hours, no edema. Pt was discharged on 8/11/01 and to follow-up with MD. Doctor dx'd "purpura". On 10/4/01, pt's mother called to inquire as to time of DTAP #5 for school. Mentioned a "problem" after IPV + MMR as noted above. This was 1st knowledge of any adverse reaction we had. Y Y 2 Y 08/09/2001 08/09/2001 0 08/20/01, Diagnostic Lab Test: Thrombopenia. Myelography - Nml. 08/21/01 Platelet count - 1000 /mm^3. 08/28/01, Platelet count - 128000 /mm^3. PUB PUB NONE Runny nose NONE 1
0176325 10/16/2001 MA 2.0 0 .8 M 10/25/2002 Information has been received from a consumer concerning her 2 year old son who was vaccinated with a 1st, 2nd and 3rd dose of Hep-B vaccine recombinant (yeast) on 10/30/98, 11/30/98 and 8/3/99, respectively. In approx. 3/01, the pt began exhibiting strange play behaviors as compared to other children. On 9/26/01, he was dx'd with "PPD". Upon internal medical review, the pt's PPD was considered to be an "Other Important Medical Event". Additional information has been requested. Follow-up info from the physician indicated that she "did not think that there was any relationship to the hepatitis B vaccine recombinant vaccine and the pt's diagnosis." Additional info has been requested. Y N 08/03/1999 03/01/2001 576 OTH OTH UNK UNK WAES01093060 1
0176328 10/16/2001 TX 4.0 4 M 09/04/2001 The child received immunizations on 8/28/01 PM and did fine. Mother noticed that child was irritable on 8/29/01 and later in the day, about 19:00, pt went outside to play X 15-20 minutes and mother noticed area was red. Mother brought child to clinic on 8/30/01 for comfort measures. Reviewed with instructions to see LMD if problems persisted or worsened. Diagnosed with cellulitis. Y 2 Y 08/28/2001 08/29/2001 1 CBC; Chem 7 done in hospital PUB PUB PPD/Mantoux Skin Test/Aventis-Pasteur/C063AA/ID/LA/1 previously NONE NONE TX01135 1
0176329 10/16/2001 MA 0.08 0 .1 F 10/09/2001 The day after the 2nd Hep-B, the pt was very listless; decreased interaction; decreased strength and tone. No fever. NOTE: See twin brother below. Y Y 09/24/2001 09/25/2001 1 CBC; LP; CT Scan at hospital-neg PUB PUB NONE NONE ~Measles + Mumps + Rubella (no brand name)~~1.50~In Sibling 1
0176330 10/16/2001 NJ 0.8 0 .9 M 09/26/2001 The patient's mother reports the patient developed a runny nose, sneezing and a cough the morning after the vaccine. The patient was seen at the ER with a complaint of rapid breathing and wheezing. The patient was given respiratory inhalation treatments and admitted for 24 hours. Y Y 09/19/2001 09/20/2001 1 PUB PUB NONE Allergic to cow's milk NJ200018 1
0176331 10/16/2001 GA 2.0 2 .0 F 10/15/2001 Post vax, the patient developed a 4" x 2 1/2" mild erythema around the injection site with slight swelling. Y Y 10/12/2001 10/13/2001 1 NONE PVT PVT NONE NONE NONE 1
0176332 10/16/2001 MI 0.2 0 .2 F 10/04/2001 The patient was given Tylenol before receiving vaccines and then 4 hours later the temperature began to rise and went up to 104F. The patient was taken to the ER and was told the reason for her fever was due to five shots being given at once. Y Y 08/03/2001 08/03/2001 0 UNK PUB PUB NONE NONE NONE 1
0176333 10/16/2001 WI 1.0 1 .0 M 10/04/2001 Post vax the patient developed a 3cm x 3cm warm tender erythema lesion at the injection site on the left thigh. U 10/02/2001 10/04/2001 2 NONE PVT PVT NONE NONE 1
0176334 10/16/2001 KS 1.08 1 .1 M 10/09/2001 Varicella vaccine given 03/19/2001. Developed vesicular rash on pt lower extremity 10/04/2001. Pt very fussy with it and was scratch in it. Seen at urgent care 10/07/2001 and diagnosed varicella and given Acyclovir and Benadryl. On 10/09/2001 has excoriated vesicular rash confined to pt thigh, primarily anterior knee and one spot on pt lower back near spine. Y N 03/19/2001 10/04/2001 199 Varicella zoster, still very fussy. Still recovering. PVT PVT NONE 1
0176335 10/16/2001 TN 0.18 0 .2 M 10/08/2001 Mom reports about 2 pm 10/01/2001 child started vomiting and running fever, 101 (R), legs swollen on injection sites. States gave Tylenol and used cold compresses on legs. Called Dr. brought on by Hib Vaccine causing reaction. She called ER. On 10/05/2001 vomiting, fever. Y 10/01/2001 10/01/2001 0 PUB OTH Tracheotomy 09/11/2001 - collapsed airway, milk allergy. 1
0176336 10/16/2001 MI 39.0 39 F 10/15/2001 24 hours post vax, the pt developed erythema, pain and swelling of upper left arm which persists to date 10/5/01. N 09/27/2001 09/28/2001 1 PUB PUB Zoloft NONE 1
0176337 10/16/2001 NJ 25.0 25 F 10/12/2001 Pt describes that she felt symptoms after vaccination. She felt "light-headed", "shaky", "racy heart". Today she awoke this morning feeling numbness in the left leg. Advised her to consult her PMP. Conformation that 25 year old female had reported recovery by 10/12/01. Best information available indicates that pt has had no previous doses of flu vaccine and that she has no history of adverse events related to vaccines. Y 10/11/2001 10/11/2001 0 OTH PVT BC pills NONE Allergies to PCN 1
0176338 10/16/2001 KS 58.0 59 F 10/13/2001 The day after vaccine was given, the pt had a fever, weakness, joint aches (states she could barely move) and "felt funny". She did miss 2 1/2 days from work but did not see a doctor and did not call a doctor's office. A follow up report received 11/1/2001 adds: Reporter states that pt did have labs drawn but didn't see her physician. She has subsequently recovered. She had no other vaccine at this visit and no other in the previous 4 weeks. She did report "achy" 2 years ago with flu shot then but no severe effects. Y 10/02/2001 10/03/2001 1 CPK-247; WBC-11.2; Sed Rate-42 and all other values were WNL. PUB OTH NONE NONE Allergies to MS, PCN. Achey~Vaccine not specified (no brand name)~~56.00~In Patient 1
0176339 10/16/2001 SC 55.0 55 M 10/08/2001 On 10/5/01 at 19:30, the pt hand chills, fever, flushing and shaky and at 22:30 had nausea. On 10/6/01 at 07:00, the pt had chills, fever and loss of appetite. Treated with aspirin and increased fluids. On 10/7/01 at 07:00, the pt had aching joints and weakness. Treated with aspirin and increased fluids. On 10/8/01 at 07:00, the pt had weakness and felt "wrung out". On 10/9/01 at 03:00, the pt had weakness and "no energy." A follow up report received 10/19/2001 adds: Nurse confirmed pt's hx of illness. Confirmed that he also has hypertension. Reporter shared that there had been a great amount of cold and flu/cough etc in area at the same time of this man's problems. Y 10/05/2001 10/05/2001 0 PUB PUB Diazide; Klonopin; allopurinol; Percocet NONE Allergy to IVP dyes; Intestinal Bypass; Kidney stones Fever~Smallpox (Dryvax)~1~5.00~In Patient 1
0176340 10/16/2001 MD 63.0 63 F 10/12/2001 Pt developed a localized left deltoid edema and macula erythema. A follow up report received 10/26/2001 adds: Pt received Pneumovax vaccine to left arm and Fluvirin vaccine to right arm on 9/26/01. Reaction occurred approx 3 hours after vaccination-with swelling and redness of left arm. Pt was seen in MD's office on 9/27/01. No treatment was required. Pt fully recovered. Y 09/26/2001 09/26/2001 0 NONE PVT PVT Premarin; Synthroid; Claritin-D; desipramine NONE Hypercholesterolemia; Hypothyroid 1
0176341 10/16/2001 CA 40.0 40 M 10/12/2001 Pt developed a temperature of 103F, swelling and redness of arm and painful to move. Treated with aspirin, Tylenol and ibuprofen. Was test for Staph and was negative at time of vaccine. Y 10/09/2001 10/09/2001 0 NONE PVT PVT NONE NONE Allergy to poison oak Fever~Typhoid Vi Polysaccharide (no brand name)~~12.00~In Patient 1
0176342 10/16/2001 IN 60.0 60 F 10/10/2001 Check out large 3 x4 red knot on arm, hot to touch, pain decreased arm. N 10/04/2001 10/04/2001 0 PVT PVT Vioxx, Evil, Priluac Sulfa 1
0176343 10/16/2001 IN 58.0 58 M 10/10/2001 Pt c/o 3 X3 red, rash area, very warm to touch, whole upper arm aches. Advised oral Benadryl-topical hydrocortisone. Y 10/04/2001 10/04/2001 0 PVT PVT Viodex, Ativan, Prilosec NONE NONE 1
0176344 10/16/2001 TX 10.0 10 F 08/27/2001 Pt's symptoms were lightheadedness, pale, sweaty palms, nausea and weakness. Cool cloth to face and back of neck while seated. Took deep breathes. Pt has no apparent fear of needles. Had Wilm's tumor removed at 2 yr's old followed by 2 yrs of chemo. After 5-10 minutes Mother felt child was fine to leave. Color had returned to cheeks and no nausea. Stood up w/o dizziness. Mother intentd to keep pt from school today. At 06:00 pm Mother reports child is feeling fine with no furthur incident s occurring. Y 08/27/2001 08/27/2001 0 PUB PUB UNK NONE TX01137 1
0176345 10/16/2001 TX 5.8 5 F 09/05/2001 The patient developed a reddened area on the left arm the size of a 1/2 dollar approximately 2 to 3 hours after the injection. On 09/04/2001 the patient experienced vomiting. On 09/05/2001 the patient's temperature was 104F. The patient was treated with Tylenol and Benadryl. Y U 09/04/2001 09/04/2001 0 PUB PUB NONE NONE Fever and swollen leg.~DTaP (no brand name)~3~0.00~In Patient TX01136 1
0176346 10/16/2001 TX 6.0 1 .5 F 09/06/2001 Came in Clinic due to rash, sores all over body times days. No fever, with central vesicle appears cloud.l Y Y 11/05/1996 09/02/2001 1762 With varicella therapy with Aveeno bathes, atarare syrup and responding. PUB PVT Allergies PCN TX01134 1
0176347 10/16/2001 TX 14.0 14 F 09/15/2001 Immediately after administrated Immunization,pt check out dizziness, noticed very pale. Ammonia inhaler place nostrils, elevated legs,epic nephrite, 3 cc administered Pulse was weak, chest pain. Y Y 08/30/2001 08/30/2001 0 PUB UNK TB Test TX01133 1
0176348 10/16/2001 TX 14.0 14 F 08/22/2001 Pt brought into clinic by Mother. Pt broke out in hives same day as receiving IZ's. No other possible potential cause for hives identified. No new foods, soaps or other medications, etc. Y Y 08/08/2001 08/08/2001 0 NONE PUB UNK NONE NONE TX01132 1
0176349 10/16/2001 TX 4.0 4 F 08/31/2001 Mother c/o bumps coming out on body around 09:45, 15 min afternoon immunizations, epinephrine 1:000 1cc SQ given and Benadryl 0.4cc IM left thigh was given. Vital signs taken and Temperature was98.1, pulse 118, respirations20. NP notified around 0945, Dr notified. Y 08/31/2001 08/31/2001 0 NONE PUB PUB NONE TX01131 1
0176350 10/16/2001 NY 0.7 0 .6 M 10/12/2001 The day following the vaccination noticed rash on the face which gradually became bigger and redder. In clinic today noticed maculopapular rash over forehead, nose neck and sparingly on trunk. Possibly viral exanthema or allergic reaction. Benadryl prescribed. Y 10/10/2001 10/11/2001 1 NONE PUB OTH NONE NONE NONE 1
0176351 10/16/2001 TX 10.0 10 F Mother stated pt broke out in hives and has swollen glands. She had been taken Benadryl for itching. PA-C put on Claritin. Y Y 08/21/2001 08/23/2001 2 See lab report PUB PUB NONE NONE NONE TX01139 1
0176352 10/16/2001 OH 10.0 9 M 05/23/2001 Went to get up immediately after receiving immunizations, slumped forward and had a seizure for approximately 30 seconds. No prior hx of seizures: healthy that day. Y 05/23/2001 05/23/2001 0 NONE PUB PVT NONE NONE NONE 1
0176353 10/16/2001 MI 29.0 29 F Pt called Health Ctr to report that after receiving menomune injection on 10/04/01 she developed fever of 99-402.0. She was tired with dry cough . On 10/08/01 fever was down. She had a non productive cough then fever back up to 101. When saw Dr at the Family Practice who provided RX and told her it was an allergic reaction to Menomune injection. Y Y 10/04/2001 10/05/2001 1 OTH PVT Allergies to codeine, tetracycline, erythromycin 1
0176354 10/16/2001 DC 27.0 27 F 09/24/2001 Swollen, hot , red lump on arm. Ran to office and felt breathless. Was told to take Benadryl for 4-6 hrs and felt better in 24 hrs. Y 09/21/2001 09/22/2001 1 NONE OTH OTH NONE NONE NONE 1
0176355 10/16/2001 AL 29.0 29 M 10/05/2001 Swelling in left arm after pneumovax. U 10/03/2001 UNK UNK 1
0176356 10/16/2001 OH 42.0 42 F 05/18/2001 Twenty minutes after injection left arm became very heavy, sharp tingling sensation and increased pain. Drove home, started dinner. Took Advil 2 tabs for pain. At 4:30 ate macaroni & cheese. Lay down and fell asleep for 1/2 hr. Became nauseated, abdominal cramps and diarrhea lasted until 6 pm. Arms, legs, and feet cold and tingly. Then began to feel a little bit better. Next day no arm pain felt back to normal self. Y 05/17/2001 05/17/2001 0 NONE OTH PUB Synthroid, Premarin NONE Under active thyroid 1
0176357 10/16/2001 MD 4.0 4 M 10/08/2001 Onset of muscle weakness, increased CPK approximately 1 week after administration of MMR, DTAP, and IPV. Y 10/23/2000 01/03/2001 72 Muscle bx, EMG per pediatric neurologist. PVT PVT NONE NONE 1
0176358 10/16/2001 NY 1.08 1 .1 M 10/05/2001 Generalized hives Y 09/25/2001 09/26/2001 1 NONE PVT PVT NONE 1
0176359 10/16/2001 MA 4.2 4 M 10/09/2001 Severe swelling, redness, tenderness of deltoid around 24 hours after vaccine was given. Y 10/02/2001 10/03/2001 1 NONE PVT UNK NONE NONE NONE 1
0176360 10/16/2001 MI 1.0 1 .0 M 10/08/2001 Fever for 48 hrs and worsening thick nasal discharge. Seen at Dr on 10/8 and Dx with viral URI and bilateral acute otitis media. Treated with Amoxicilln. Y U 10/03/2001 10/03/2001 0 PUB PUB NONE Viral URI NONE 1
0176361 10/16/2001 TX 5.0 1 .0 M 10/10/2001 Received varicella vaccine on 9/17/97 and diagnosed with varicella on 10/5/01. 3 stages of lesions to scalp, trunk and proximal extremities. Y Y 09/17/1997 10/05/2001 1479 NONE MIL MIL NONE NONE NONE 1
0176362 10/16/2001 TN 1.25 1 .3 M 10/05/2001 Had a one minute spell of starring into space on the day after getting vaccines. Was immediately well. Has history of myoclonic activity prior to 1 yr of age. Y 04/23/2001 04/24/2001 1 NONE PVT PVT NONE Asymtomatic remission of chronic constipation. Myoclonic activity early in life, now resolved. Egg allergy. 1
0176363 10/16/2001 NY 43.0 43 F 09/12/2001 2 hours after IZ client developed severe dizziness, intermittent chest pain, fever, joint and muscle pain. Advised to go to ER. Pt called next day, did not go to ER but will see private MD today. Y U 09/11/2001 09/11/2001 0 PUB PUB Celebrex NKDA, sensitive to metals, fibromyalgia and depression NYS21021 1
0176364 10/16/2001 NJ 52.0 51 F 10/10/2001 Cellulitis ABX x10 days. Y 09/13/2001 09/14/2001 1 PVT UNK NONE NONE 1
0176365 10/16/2001 NC 0.3 0 .3 F 10/10/2001 Uncontrollable, high pitched cry times 5 hours within 24 hours of vaccine in association with fever 102.2 (ax). Y 10/08/2001 10/09/2001 1 PVT UNK Seizure duration related to static encephalopathy 1
0176366 10/16/2001 MI 18.0 18 M 08/02/2001 Popular raised rash on limbs, hives, eye swelling 2 hours post injection. Y Y 08/02/2001 08/02/2001 0 PVT PVT Peanut allergy 1
0176367 10/16/2001 NY 65 F 10/05/2001 Right arm swollen, painful, red, warm from arm to elbow. Y U 10/03/2001 10/04/2001 1 PVT UNK 1
0176368 10/16/2001 MS 11.0 11 F 10/08/2001 Check out itching at site and on back. Saturday and Sunday began day within shot. Red area with peeling skin noted at place of site. Left arm. Skin peeling from back area. Temperature 99 degree. U 10/03/2001 10/04/2001 1 OTH OTH Acne medicine in AM et Dexedrine. ADD, Vitiligo 1
0176369 10/16/2001 NY 15.0 15 F Pt developed a headache, fever, wheezing and a swollen arm. Y Y 10/08/2001 10/09/2001 1 PVT UNK Asthma 1
0176370 10/16/2001 UT 67.0 67 F 09/19/2001 Red, swollen left arm and elbow below injection. No fever and chills. Benadryl 50 Mg. by mouth every 6 hours PBN, ASA pie by mouth, by mouth every 6 hours PRN, warm compressions. Call if symptoms worsen. Y 09/19/2001 09/20/2001 1 PVT PVT 1
0176371 10/16/2001 MA 32.0 32 F 10/07/2001 Retrobulbar optic neuritis diagnosis 7/5, 6/28 Onset of symptoms, 7/3 MRI, 7/5 Diagnosis, 10/7 Still not 100% recovery. Y N 05/29/2001 06/28/2001 30 PVT PVT NONE NONE Morphine allergy 1
0176372 10/16/2001 TX 4.0 4 M 09/19/2001 Pt had redness, warmth and swelling at site of MMR on 09/18/2001. Child seen if office 09/19/2001. Redness, warmth, nontender area upper left thigh. Area 12 cm X 9.5 cm. Y U 09/17/2001 09/18/2001 1 PVT PVT 1
0176373 10/16/2001 TX 1.5 1 .6 M 09/18/2001 Developed rash in diaper area on Friday afternoon on 9/14/01. By Saturday 9/15/01 rash covered entire body and was running a fever that got up to 103. Reported to ER and physician instructed Mom to give Tylenol and Motrin. Report back to ER if symptoms and rash increase and follow up with PCP in 3-5 days if no improvement. Y Y 09/11/2001 09/14/2001 3 NONE PVT PVT NONE NONE redness,and knot in jection site~DTaP (no brand name)~3~0.50~In Patient 1
0176374 10/16/2001 TX 11.0 10 M 09/21/2001 3 hours of within injection, child developed swollen eyes, lips and red blotches to entire torso. Mom gave child Benadryl, times 3 doses, mom didn't call until 09/21/2001, she called to schedule FLU appt, it was then that she told of reactions. Y 04/24/2001 04/24/2001 0 PVT OTH Allergic to PCN TX01142 1
0176375 10/16/2001 TX 1.0 1 .2 F 09/21/2001 Within 10 minutes, post vax, pt developed an irregular border 50mm to 60mm circular, pale redness noted around the injection site on right and left arms. Redness continued to intensify. At 16:50, they were 50 cent-sized. Bright red area to definite border, 10-15mm wheal at both injection sites. At 16:55, gave 4.5ml Benadryl po and at 17:10 the redness and wheal had decreased slightly. At 17:40, only slight redness remained on each arm, wheal had disappeared. Discussed danger signs, swelling of lips or face, difficulty breathing and instructed to call 911 if occured. Benadryl sent home with mom. Instructed to observe arms closely, give 1/2 to 1 tsp if needed in 4-6 hours. Y 09/18/2001 09/18/2001 0 PUB PVT Poly D Elixer 1/2 tsp BID NONE NONE TX01141 1
0176376 10/16/2001 TX 11.0 11 M 09/14/2001 9/12/01 evening red area and itching. 9/13/01 Red area on arm swelled to size of dime. 9/14/01 red area on arm swelled to size of a half dollar. Mother gave child Advil. U 09/12/2001 09/12/2001 0 PUB UNK NONE NONE NONE 1
0176377 10/17/2001 NY 63.0 63 M 01/14/2002 The patient was seen by his rheumatologist on 07/18/2001. At this time, his blood pressure was 158/80 mmHg; the heart rate was not noted. The rheumatologist prescribed celecoxib (Celebrex) as need for relief of an unspecified form of knee arthritis. The patient also received, per his request, the 1st injection of Lymerix. The patient was admitted to the hospital on 08/10/01, 23 days post-immunization, with hypotension, fever of 104 F, and 2nd degree atrioventricular block (NOS). An unspecified cardiac pacemaker was inserted. The patient was seen by the rheumatologist on 09/05/01. A Lyme disease ELISA antibody screen and Western Blot were performed. The second injection of Lymerix was administered. Subsequently, the Lyme Disease ELISA showed an index of 4.02; the Western Blot was "negative". On 09/22/01, 17 days following receipt of the 2nd injection of Lymerix, the patient suffered a witnessed sudden death at a service station. An autopsy was performed; results were not available as of 10/03/01. The most recent info received on 01/14/2002 provided the lot number of vaccine administered on 09/05/2001. Y 09/22/2001 Y N 09/05/2001 09/22/2001 17 09/05/01, Lyme Elisa Antibody Index - 4.02. Lyme Western Blot - "Negative". 09/01, Autopsy - results not provided. OTH OTH Diltiazem (Tiazac;dosage unk), hydrochlorothiazide, warfarin (Coumadin), and celecoxib (Celebrex). Hypertension, unspecified arthritis in the knee, hypokalemia. There was no history of Lyme disease although, he frequented and endemic area. 20010242571 1
0176383 10/17/2001 NM 44.0 43 F 10/08/2001 Pain in knees began in 1995 with a steady increase in pain and swelling, intermittently, primarily climbing stairs. Unresponsive to NSAIDS and steroids. Became disabled 2/27/01. Left knee replaced on 7/10/01. Y Y N 08/02/1993 06/01/1995 668 All cultures, autoimmune work-up negative X 2; had many arthrocentesis. PVT OTH NONE NONE NONE 1
0176384 10/17/2001 MI 0.08 0 .1 F 10/08/2001 The day after 2nd Hep B shot (07/11) our daughter got real lethargic and stopped eating well and stridor started. Stridor was very bad and she was not gaining any weight and had to work very hard to breathe. Daughter ended up being diagnosed with bilateral vocal cord paralysis. Received a laryngoscopy and MRI. Y Y 1 Y 07/10/2001 07/11/2001 1 Laryngoscopy; MRI; CBC; CXR's PVT PVT NONE NONE 1
0176385 10/17/2001 SC 1.08 1 .1 M 10/08/2001 Child was taken to ER via EMS with a history of a seizure at home. Mom stated that it started that AM. Y Y 1 Y 10/03/2001 10/04/2001 1 PVT PUB Histox Pd Severe atopic dermatitis; diarrhea secondary to over consumption of juice/sugar drinks 1
0176386 10/17/2001 IL 36.0 36 M 10/08/2001 Pt complained of severe headache for 2 days. Seen by MD and was hospitalized. Y Y U 09/17/2001 09/30/2001 13 MIL PVT Vitamins, Tylenol NONE GI distress, ASA allergy 1
0176387 10/17/2001 VA 1.41 1 .4 F 10/06/2001 Pt developed a temperature to 104 F the evening of 10/4/01 and then had a febrile seizure. She was taken to the ER where she was evaluated and monitored. She was discharged home later that evening. Y Y 10/04/2001 10/04/2001 0 Urine and blood cultures were negative PVT UNK NONE Otalgia NONE 1
0176388 10/17/2001 CO 0.4 0 .4 F 10/10/2001 Febrile most of the day after vaccines. At 2 AM on 10/9 made choking noises in bed. Felt very hot. Parents gave Tylenol. Soon after face, neck and tongue became puffy and swollen and started to choke. Turned pale, then eyes rolled back and became limp. Temperature was 103 when EMT arrived. Became more alert with resolution of swelling within 1 hour. Y Y 10/08/2001 10/09/2001 1 UA and chest x-ray normal. WBC 14,000. 56 poly, 29 lymph no bands. PVT PVT NONE NONE NONE 1
0176389 10/17/2001 PA 1.0 0 .6 M 09/15/2001 Fever, red spots on head (Hives) tired, crying. Bad reaction to either combination of shots or prevnar. Y 07/14/2000 07/15/2000 1 PVT PVT No Tylenol given at all. Fever, tired, crying, hives. NONE 1
0176390 10/17/2001 CA 0.3 0 .4 F 09/27/2001 Fever of 100.3 on 9/26/01. Fever down to 96.9 on 9/57/01. Rash began on 9/26 on feet then moved to chest, axilla, ankles face. Y 09/25/2001 09/26/2001 1 PVT PUB NONE NONE 1
0176391 10/17/2001 WI 1.0 1 .5 M 09/19/2001 Pt began to run fever at midnight, temperature of 103. rolled eyes back, began to tremble, seizure lasted 1 minute. Child unconscious, very purple lips, and difficulty breathing. Mom breathed in his mouth. Called 911, taken to hospital, given Tylenol and released after 2 hours. Y Y 08/28/2001 09/10/2001 13 PUB PVT 1
0176392 10/17/2001 NY 1.5 1 .5 F 10/10/2001 the morning after immunizations was administration (only vaccine given at that time). Child awoke with hives over entire body and fever of 102. Hives and fever for 24 hours and lethargy 2-3 days. Y 04/19/2001 04/20/2001 1 PVT PVT NONE NONE NONE 1
0176393 10/17/2001 CA 1.03 1 .0 M 10/05/2001 The patient developed urticaria 4 hours after the injections. Y Y 10/05/2001 10/05/2001 0 NONE PVT PVT NONE NONE NONE 1
0176394 10/17/2001 WA 1.4 1 .5 M 10/11/2001 Patient's parent noted swelling the morning following the vaccine. The patient had some temperature but that resolved. By the 2nd day the patient had a 2 inch swollen area but no redness or tenderness. Y 10/08/2001 10/09/2001 1 PVT PUB NONE 1
0176395 10/17/2001 IL 40.0 40 M 10/11/2001 Pt developed chills and shivering that started at 21:00 and continued all night. Y 10/10/2001 10/10/2001 0 NONE OTH OTH NONE NONE Seasonal hay fever 1
0176396 10/17/2001 IL 43.0 43 M 10/11/2001 Pt developed chills and uncontrollable shivering. A follow up report received 10/18/2001 adds: Reporter states pt had chills lasting several hours. Did not take temperature; went to bed and recovered with rest. No sequeale to this symptom. Y 10/10/2001 10/10/2001 0 NONE OTH OTH NONE NONE NONE 1
0176397 10/17/2001 FL 93.0 93 M 10/10/2001 Pt developed diffuse rash and itching X 4 days. Treated with Benadryl and Atarax. A follow up report received 10/19/2001 adds: Physician states family reported "AE" but not able to recall what type distress pt had; Nurse Practitioner went ahead with immunization. Symptoms did subside with 4 days of treatment with Benadryl and Atarax. He's otherwise doing well and his mind is clear. Y 09/20/2001 10/26/2001 36 NONE OTH PVT Captrapril, Lasix, Flomax Atrial Flutter/CHF; Osteoarthritis Rash~Influenza (Seasonal) (no brand name)~~0.00~In Patient 1
0176398 10/17/2001 FL 42.0 42 F 10/11/2001 Sore, lump, red, and itching at the site. Symptoms started 24 hours after injection. Also "lumps" inner aspect of the upper arm. No treatment. A follow up report received 10/18/2001 adds: Pt reports she has almost completely recovered from site reaction. Had no other vaccine at that date; has had no other vaccines in past month. Has had flu vaccines for the last 3 years and has never had an AE previously. U 10/04/2001 10/05/2001 1 NONE PVT PVT NONE NONE NONE 1
0176399 10/17/2001 MD 87.0 87 M 10/11/2001 Acute generalized urticaria. The patient was placed on Benadryl for urticaria which progressed as any other problems. He received no other vaccines on that day, he is on no regular meds has had 3 other recorded flu shots, but has never before had an adverse event to any vaccine. Y Y 10/10/2001 10/10/2001 0 PVT PVT NONE NONE 1
0176400 10/17/2001 LA 6.0 6 M 10/11/2001 This patient received a flu shot on 10/10/2001 and the following morning broke out in whelps on his back, ear, neck and chest. Saw the doctor 10/11/01. The doctor order Atarax and Patanol for eyes itching and redness. The child also complained of headache and eyes were swollen. Follow up 10/19/2001: "RN confirmed that child was improving when seen in the office morning of October 11; he was given the meds to decrease the time to fully recover from the urticaria and rash. No other vaccines at this visit, no vaccines in previous 4 weeks, no history of adverse events for child. " Reporter confirmed that child was improving when seen in the office morning of Oct 11: he was given the meds to decrease the time to fully recover from the irticaria and rash. No other vaccines at this visit, no vaccines in previous 4 weeks, no Hx of AE for child. Y Y 10/10/2001 10/11/2001 1 NONE PVT PVT Adderall NONE Asthma, ADHD 1
0176401 10/17/2001 FL 65.0 65 F No data entered A follow up report received 10/19/2001 adds: Became "sick", weak, dizzy, lightheaded and feverish (temp 100) evening of 10/4/01. Ached all over. Took Ibuprofen before going to bed-felt much better in AM. Arm black and blue for 2 weeks. Y 10/02/2001 10/04/2001 2 UNK UNK Prilosec, Ibuprofen NONE Rheumatoid arthritis, Gastric reflux 1
0176402 10/17/2001 VA 4.0 4 M 10/11/2001 Hives at the vaccine site and even all over his body within 15 minutes. Benadryl with resolution in 10 minutes. Follow up 10/19/2001: "MA who gave vaccination confirmed that child received flu shot only. No other vaccines given in the previous 4 weeks; mother did elude to a possible egg sensitivity. Report correct; child did clear within 10 min of receiving benadryl." MA who gave vaccination confirmed that child received flu shot only. No other vaccines given in the previous 4 weeks: mother did elude to a possible egg sensitivity. Report correct: child did clear within 10 mins of receiving benadryl. Y 10/10/2001 10/10/2001 0 PVT PVT 1
0176403 10/17/2001 NV 20.0 20 M 10/08/2001 Pt complained of itching to left deltoid where vaccination given. Upon removing band aid, redness to site Treated with Benadryl. Y 10/08/2001 10/08/2001 0 PUB PVT NONE diarrhea, nausea , headache 1
0176404 10/17/2001 MI 4.6 4 M 09/28/2001 A 4 year 9 month old boy developed left parotitis, 6 weeks post vax. He has no other symptoms of illness besides sore neck and swelling of the left parotid gland. Y U 08/15/2001 09/26/2001 42 On 9/26/01 Hgb-11.7 g/dl; Hct 34.5%; WBC-6.7; 61 polys; 25 lymphs; 11.7 monos; Amylase-243 IU/L (nml 30-100); LDH-278 IU/L (nml 170-320) OTH OTH Mild viral gastroenteritis on 9/13/01 1
0176405 10/17/2001 WI 34 F 10/04/2001 On 09/27/2001 it was reported that on 09/18/2001 the patient experienced a severe headache, nausea and vomiting. On 09/19 the nausea and vomiting subsided but the headache remained. No medical care as symptoms slowly resolved over 72 hours. 09/18/2001 09/18/2001 0 NONE UNK UNK NONE NONE 1
0176406 10/17/2001 NJ 27.0 27 F 09/28/2001 The patient developed a pruritic rash over her entire body which began shortly after receiving the injection. The patient also complained of puffiness of her eyes a scratchy throat with the sensation of her throat swelling. A physical exam revealed a diffuse urticarial rash over her face, neck and eyelids. The patient was treated with Benadryl and SoluMedrol with resolution of the rash and itching. The patient was discharged with Prednisone. 07/03/2001 07/03/2001 0 NONE UNK UNK Allergic to Augmentin and Penicillin. 1
0176407 10/17/2001 OK 22.0 22 F 10/09/2001 Seizure new onset. Y Y 09/07/2001 09/15/2001 8 CT Scan, EEG done at ST Mary's hospital in Einol all within normal limits. OTH UNK Depo Provera NONE Asthma, drug allergy to Augmentin 1
0176408 10/17/2001 WI 55.0 5 M Vaccination given in the A.M. The patient woke up at 7 P.M. with full body hives. The mother states he has some swelling of the mouth and congestion. U 10/03/2001 10/05/2001 2 PVT PUB 1
0176409 10/17/2001 WA 2.0 2 .1 F 10/05/2001 Circular redness on right thigh, local reaction with sterile abscess. Y 10/02/2001 10/04/2001 2 NONE PVT PUB NONE NONE ? development delay 1
0176410 10/17/2001 VA 1.3 1 .3 M 10/11/2001 Post vaccination the patient developed thrombocytopenia, the platelet count decreased to 26,000. The patient had spontaneous recovery in 1 week. Y Y 09/05/2001 10/01/2001 26 CBC x 4 PVT PVT NONE NONE 1
0176411 10/17/2001 NC 1.5 1 .5 M Post vax, the patient developed a 3cm x 5cm welty redness with minimal tenderness. U 10/08/2001 10/09/2001 1 PVT PUB NONE 1
0176412 10/17/2001 CA 4.0 4 F Localized redness, warmth and tenderness. Started day after shots. Treated with ice and Benadryl. Fully resolved by 10/01/2001. Y Y 09/24/2001 09/25/2001 1 PPD given, lot number 00241P given on 9/24/01. UNK UNK NONE NONE 1
0176413 10/17/2001 LA 70.0 M 10/11/2001 Post vax, the patient developed swelling of the arm around the injection site. Y 10/08/2001 10/09/2001 1 PVT UNK 1
0176414 10/17/2001 AR 5.0 5 F 08/03/2001 Mother states post vax, patient woke up with a puffy face that was red and warm to touch. The mother treated this with Tylenol. Mother also states the patient's lower arms and lower legs are blotchy and warm to touch. Child is irritable and scratching face. Mother denies any new foods or previous reactions. Patient referred to Dr. Y U 08/01/2001 08/03/2001 2 PUB PUB NONE NONE NONE AR4101 1
0176415 10/17/2001 AR 1.08 1 .1 M 08/06/2001 Mom was at clinic with sister. Stated child had seizures with last shots and didn't realize she needed to tell us. Had low grade temp the evening of the shots. At 48 hrs temp went to 103 and began having seizures. Ambulance took child to ER. Fever got to 104. Mom states she was giving Tylenol but it was not working. PMO stated the episode was related to IZ's. Y Y 03/07/2001 03/09/2001 2 NONE PUB PUB NONE NONE NONE AR4201 1
0176416 10/17/2001 IL 5.0 0 1 F 10/10/2001 The patient was exposed to chicken pox at school. The patient now has a few scattered chicken pox lesions on her face, stomach, back, arms and legs. Y 07/19/1997 10/07/2001 1541 NONE PVT PVT NONE NONE NONE 1
0176417 10/17/2001 MI 1.0 0 1 F 10/11/2001 Post vax, the patient had a fever of 103 for 48 hours, was irritable and unconsolable for 3 days, and then sleepy for 2 days. The patient was treated with Tylenol and observation. Y 09/10/2001 09/10/2001 0 NONE PVT PUB NONE NONE NONE ~DTP (no brand name)~1~0.50~In Sibling 1
0176418 10/17/2001 TX 1.25 1 .3 M 10/11/2001 Mom reports onset of rash 3 days post varicella vaccine. Lesion noted 1st on face and progressed to entire body. Pt had around 30 lesions. Lesions are mostly maculo-papular. Few lesion on extremities have vesicles. No puritis, temp, or irritability with lesions. Advised conservative measures as follow up. Y 10/03/2001 10/06/2001 3 NONE PVT PUB NONE NONE NONE 1
0176419 10/17/2001 TX 17.0 16 F 10/11/2001 Subsequent to the vaccination, OB ultrasound on 10/05/2001 revealed approximately 3-4 weeks gestation at time of vaccine administration. U 07/30/2001 Negative urine HCG - OB ultrasound on 10/05/2001 PUB PUB NONE Pregnant - not diagnosed - undetected with urine HCG 1
0176420 10/17/2001 IL 1.1 1 .2 F 10/03/2001 Immediately after injection, the patient had a local reaction noted at the site. The injection site was red, with a raised rash above the injection site with one pustular area below the injection site. Treated with Benadryl. Y Y 10/03/2001 10/03/2001 0 NONE PUB PUB NONE NONE Allergies to pollen and dust 1
0176421 10/17/2001 VA 5.0 8 M 10/05/2001 Pt had swelling, redness, fever, tenderness. DX was cellulitis. Treatment was elevation, cool compresses, Ibuprofen, Keflex for 5 days. Y 10/03/2001 10/05/2001 2 PVT PUB NONE NONE NONE 1
0176422 10/17/2001 FL 1.0 0 1 F 10/11/2001 Nine days post vax the patient developed a case of varicella, greater than 100 lesions over her face and trunk. Y U 10/02/2001 10/09/2001 7 NONE PVT OTH NONE NONE NONE 1
0176423 10/17/2001 NY 0.2 0 .2 M 10/05/2001 Pt became fussy and screamed after shots and had slight temp-lasted over 24 hours. Gave Levsin drops and Tylenol with good results. Y Y 10/04/2001 10/04/2001 0 NONE PVT PVT NONE NONE NONE 1
0176424 10/17/2001 NE 14.0 14 M 10/01/2001 Approximately 6 minutes after receiving vaccination, the patient fell backwards. He was out cold for a couple of minutes and would not respond to his name. After elevating his legs for about 5 minutes he regained consciousness. The patient then felt nauseated, dizzy and weak. The patient recovered in about 1 hour. Y 09/10/2001 09/10/2001 0 PVT PVT NONE NONE Asthma 1
0176425 10/17/2001 TX 1.5 1 .5 F 10/08/2001 The patient's parents report the onset of a papular rash with vesicles/pustules on 10/04/2001. Y 09/27/2001 10/04/2001 7 NONE PVT PUB NONE NONE NONE 1
0176426 10/17/2001 MI 5.0 5 M Left deltoid area red, swollen , warm, tender, oozing, central serosang oozing. Y Y 09/19/2001 09/20/2001 1 NONE PUB OTH NONE NONE 1
0176427 10/17/2001 CO 74.0 74 F 10/10/2001 The patient experienced diffuse redness, swelling and erythema of the right arm after vaccination. Y 10/09/2001 10/09/2001 0 NONE PVT PVT Synthroid, Estrace, Nicorette, Plavix, Avapro, Celebrex NONE Allergies to penicillin, sulfa, erythromycin, iodine, indocin, and aspirin. Hypertension, hypothyroidism, TIA, osteoarthritis Local Reaction~Influenza (Seasonal) (no brand name)~~0.00~In Patient 1
0176428 10/17/2001 NM 30.0 30 M 09/26/2001 Post vax, the patient complained of paresthesia to the scotal area. Patient feels funny. U 09/12/2001 09/14/2001 2 NONE PVT PUB NONE NONE NONE 1
0176429 10/17/2001 LA 0.7 0 .7 M 10/11/2001 After IZ HBV injection child had breath holding episode that required mouth to mouth resuscitation. Y Y 10/11/2001 10/11/2001 0 NONE PVT PUB cold and skin allergies allergic rhintis 1
0176430 10/17/2001 CA 10.0 10 M 10/11/2001 Post vax the patient developed a red patch on his arm surrounding the injection site, then became faint and vomited. The redness went away after a couple of minutes. Y 10/04/2001 10/04/2001 0 NONE UNK UNK NONE NONE Possible sulfa meds allergy 1
0176434 10/18/2001 MA 2.0 M 02/13/2002 A physician reported that a 24 month old male received his 1st dose of Prevnar in 7/01 and 2 or 3 hours, post vax, experienced hives. His hives improved; however, the pt continued to experience generalized body hives and angioedema of the face, lips and eyes. His hives persisted for 2 months. As of the date of this report, no further information was available. Angioneurotic edema is considered "Medically Important. Follow up info received 2/11/02 indicated that at the time of this event, the pt had a complete blood count with differential, ANA, ESR and immunoglobulin testing and all results were normal. The pt's symptoms subsided 2 months later. Y Y 07/01/2001 07/01/2001 0 Full blood count normal; erythrocyte sedimentation rate normal; antinuclear antibody normal; immunoglobulins normal OTH OTH UNK NONE UNK HQ7074412OCT2001 1
0176444 10/18/2001 5.0 M 10/17/2001 On 8/7/00, the child received his 1st injection of Infanrix. On that date, he also received his 2nd injection of MMRII and his 1st injections of varicella and IPOL. On 8/10/00, the pt experienced left testicular swelling, mild erythema of the left scrotum with generalized tenderness and swelling. The pt walks with legs slightly abducted. The pt's dx was orchitis. The pt's mother stated that "we can only conclude that it was a reaction to the vaccine". He was seen by a pediatric urologist who reported "that there had not been a documented case of this type of reaction in a juvenile in over 17 years". The reporter considered the pt's experience to have resulted in a significant disability. Follow-up information from a nurse, stated "she vaguely recalled this child's experience and believed he had seen a pediatric urologist who was not the primary physician treating the pt for this experience". The nurse also stated "she thought it was the urologist who felt the child's orchitis was related to MMRII vaccination, though she was not certain of this". She also stated "that she believed the child walked with his legs abducted due to the testicular swelling and orchitis and this was not a separate experience but again she could not definitively state this without checking the pt's chart". Outcome of the orchitis was not provided. Y Y U 08/07/2000 08/10/2000 3 Ultrasound-test results not provided OTH OTH NONE 20010241221 1
0176446 10/18/2001 IL 1.3 M 10/09/2001 Autism Spectrum Disorder, post vax. Pt stopped talking, sitting up and seemed to not recognize daily items, like his spoon. Autistic. Y U 10/13/1992 PUB OTH NONE NONE High fever~Measles + Mumps + Rubella (no brand name)~~0.00~In Patient 1
0176447 10/18/2001 IL 57.0 56 F 10/11/2001 On 10/8/01 at 18:15, pt went to ER with itching, facial flushing, throat tightness and stridor. At 18:20, she was given epinephrine 1:1000 0.2cc SC-IV and started Benadryl 25mg IV, Solu-Medrol 125mg IV and Zantac 50mg IVPB. At 18:35, Benadryl 25mg IV was repeated. At 20:20, she was discharged home. Her temperature was 97.3F (oral); HR 120; Respirations 22 and BP 168/96 on arrival. Y Y Y 10/08/2001 10/08/2001 0 PUB PVT Drovan; Verapamil; Allegra; Singulair; Premarin NONE Asthma; HTN 1
0176448 10/18/2001 TN 2.0 2 .1 M 10/12/2001 Post vax the patient experienced shortness of breath requiring an ER visit. Y Y 10/05/2001 10/06/2001 1 PVT PVT NONE NONE NONE 1
0176449 10/18/2001 CA 0.3 0 .3 M 10/03/2001 Approximately 4 hours post vax, the patient developed a fever. The fever persisted and patient was taken to ER. Fever was 103F and patient was diagnosed with otitis media. Y Y 10/01/2001 10/01/2001 0 NONE PVT PUB NONE NONE Post Hyperlipidemia CA010112 1
0176450 10/18/2001 CA 1.1 1 .2 M 09/19/2001 Post vax the patient developed a red induration on the right arm at the deltoid muscle. Y 09/17/2001 09/19/2001 2 NONE PUB PUB NONE NONE CA010110 1
0176451 10/18/2001 CA 1.03 1 .3 M 09/14/2001 Post vax, the patient's left thigh developed redness, local reaction, and was warm to the touch. U 09/12/2001 09/12/2001 0 NONE PVT PUB NONE NONE NONE CA010107 1
0176452 10/18/2001 IL 1.1 1 .1 M 10/10/2001 The patient experienced hives by the injection site, which lasted 1 hour. The patient was treated with Benadryl. Y 10/09/2001 10/09/2001 0 NONE PUB PUB NONE NONE 1
0176453 10/18/2001 OK 4.0 4 M 10/08/2001 Post vax the patient developed a 1 1/2" round red splotchy area on his right arm in the deltoid area. Y U 10/01/2001 10/01/2001 0 PUB PUB 1
0176454 10/18/2001 IA 0.4 0 .2 F 10/01/2001 Two hours post vax the patient started crying and high pitched screaming. The patient cried for 10 straight hours and could not be consoled. The patients legs swelled for 9 days, she ran a fever of 99-101F for 5 days, and did not return to being "herself" for 1 month. U 06/26/2001 06/26/2001 0 NONE PVT OTH NONE NONE NONE 1
0176455 10/18/2001 GU 0.75 0 .8 F 10/15/2001 Pt developed erythematous maculopapular rashes mostly con fluent all over the body except face 10/14/2001, 4 days after 9 month old immunizations were given. U 10/10/2001 10/14/2001 4 NONE PVT PVT NONE NONE NONE 1
0176456 10/18/2001 KY 0.3 0 .4 M 10/16/2001 Post vax, the patient developed hives and swelling of the face. The patient was treated with steroids and benadryl. Y Y 05/21/2001 05/21/2001 0 PUB PUB NONE NONE KY2001076 1
0176457 10/18/2001 NJ 53.0 53 F 10/09/2001 See attached N 06/14/2000 06/23/2000 9 PVT UNK NONE NONE NONE 1
0176458 10/18/2001 IL 1.5 1 .5 M 10/16/2001 Fussiness x 2 nights after vaccine given. Inappropriate dose given, 0.5 ml instead of 0.25 ml Y 10/15/2001 NONE PVT PVT Zithromax Resolving otitis 1
0176459 10/18/2001 CA 46.0 46 F 10/03/2001 Within 4 hours, swelling, redness and discomfort noted left upper extremity. Also noted entire body ached plus headache. Bedridden on second day. Second day redness less, swelling into left breast. Third day swelling less, discomfort at left axilla, body ache only shoulders, neck and headache. U 10/01/2001 10/01/2001 0 PUB PUB Tamoxfin 20mg po daily NONE Breast CA, bone marrow transplant 03-29-2000 CA010108 1
0176460 10/18/2001 FL 30.0 30 F 09/15/2001 Post vax the patient complained of dizziness, disorientation, vomiting and headache. This was followed by difficulty breathing, hot and cold spells and wheezing. Patient was seen in the ER and treated with Benadryl, Zantac, Zyrtec, and Albuterol inhaler. Patient began to recover. Y Y 08/17/2001 08/17/2001 0 NONE OTH OTH NONE NONE NONE 1
0176461 10/18/2001 CA 5.9 6 M 09/13/2001 Post vax the patient complained of itching skin and by evening the patient had an urticarial rash on his trunk and earlobes. U 09/12/2001 09/12/2001 0 NONE PUB PUB Albuterol MDI, Zyrtec Syrup, Beconase Nasal Spray NONE Asthma, Allergic Rhinitis CA010106 1
0176463 10/18/2001 67.0 67 F 10/12/2001 Post vax, the patient complained of erythema, induration, and warmth to the area of injection. Dx: Allergic reaction to Pneumovax. U 10/11/2001 10/11/2001 0 UNK UNK High Cholesterol, Hypertension, CAD 1
0176464 10/18/2001 HI 53.0 53 F 10/12/2001 Post vax, the patient complained of erythema, induration and increased warmth at the injection site. This is the second reaction of this type from the same vial of Pneumovax vaccine. No history of reaction before. DX: Allergic reaction to Pneumovax vaccine. U 10/11/2001 10/11/2001 0 OTH OTH Sjorgren Syndrome and hypertension 1
0176465 10/18/2001 VA 47.0 47 F 09/24/2001 Post vax, the patient developed a nonproductive cough, rash and fever. Y Y 03/21/2001 04/04/2001 14 PUB PUB NONE VA01030 1
0176466 10/18/2001 NJ 3.0 1 .3 M 10/15/2001 The patient developed atypical varicella on 10/12/2001. Y 11/29/1999 10/12/2001 683 PVT PVT NONE NONE 1
0176467 10/18/2001 MD 18.0 18 F 10/12/2001 Two weeks post vax, the patient presented with complaint of fever, myalgias, and nausea. Y 08/17/2001 09/01/2001 15 SGOT=1119; SGPT= 987 PVT PVT NONE NONE NONE 1
0176468 10/18/2001 CA 8.0 8 F 10/13/2001 Post vax, the patient had a tonic seizure lasting 20 seconds. No cyanosis, vital signs stable, no prior history of seizures. Neuro check-nml. Referred for seizure check up. Y 10/03/2001 10/03/2001 0 OTH PUB Parkdale, PPD skin test, lot #01261P NONE NONE CA010113 1
0176469 10/18/2001 MA 19.0 F 10/13/2001 Post vax the patient developed swelling, induration and redness at the injection site. U NONE PUB PUB NONE NONE NONE 1
0176470 10/18/2001 NY 0.5 0 .5 M 10/15/2001 A few hours post vax the patient showed symptoms of apnea with periods of shaking of 15-30 seconds. The patient seemed "out of it". Y 10/10/2001 10/10/2001 0 PVT PVT NONE 1
0176471 10/18/2001 IN 62.0 62 F 10/11/2001 Complaints of on the day after the vaccine her arm got very sore, red and feverish. Saturday it was worse, hot to touch and red. We reported three other patients with the same lot number with similar reactions. Y 10/05/2001 10/06/2001 1 PVT PVT Evista, Calcium SJD ? Latex 1
0176472 10/18/2001 IN 62.0 62 F 10/10/2001 Post vax, the pt had extreme soreness in the arm, into the shoulder and down to her waist. No redness or hot to touch. Was better within 24 hours. We reported 3 other pts with the same vial with similar reactions. Y 10/05/2001 10/05/2001 0 PVT PVT Lanoxin; Ogen; Verlan; Celebrex; Leubid; Prilosec; Bumex Allergic to Macrobid 1
0176473 10/18/2001 CA 1.03 1 .1 M 09/28/2001 Post vax, on 09/16/2001 the patient's temp was 103F and he had a seizure. The patient was treated at the ER for Otitis Media. On 09/27 the patient had another febrile seizure. The mother feels this is due to the MMR vax. Mother advised if any further problems go the the ER. Y U 09/08/2001 09/16/2001 8 OTH PUB Ear Infection 2 Weeks early at birth, history of ear infections ~Measles + Mumps + Rubella (no brand name)~2~0.00~In Sibling CA010111 1
0176474 10/18/2001 CA 1.0 1 .0 F 09/17/2001 Post vax, both injection sites bled, turned red and became swollen. Pressure was applied until the bleeding stopped. A small dime sized lump palpated at the DTAP site. The mother was instructed to observe the site and if later swelling, take the patient to her physician. She will see the patient's physician tomorrow. Y 09/17/2001 09/17/2001 0 PUB PUB Propimix in formula, carnitine Bone marrow suppression as of 08/19/2001 History of propionic acidemia/difficulty processing protein CA010109 1
0176475 10/19/2001 MA 51.0 51 M 10/16/2001 On an unspecified date, the pt received injections of Engerix-B and Havrix for "revaccination". The number of previous injections of Engerix-B and Havrix were not specified. On 9/28/01, the pt was seen in the physician's office and in the ER. He was hospitalized with a dx of second nerve bilateral optic papillitis. As of 10/3/01, the event was ongoing. F/U states the vaccine provider submitted this report directly to VAERS. The pt received Hep-A on 12/14/98 and 6/14/99. On 8/31/01, the pt received injections of Havrix and Engerix-B. On 9/28/01, the pt received his 2nd injection of Engerix-B. As he drove home from the MD's office, he noticed greyness of vision at the inferior field of the left eye when he covered his right eye. On 10/2/01, he was seen by an ophthalmologist, who made a dx of bilateral papillitis, left greater than right. The pt was sent to the ER for further evaluation and was hospitalized. On admission, the pt reported that he had noted transient dizziness, lightheadedness and blurry vision while exercising 1 week prior to admission; these events resolved after several minutes. He also reported "some ill-defined mild decrease in concentration skills and general fatigue up recently. The dizziness, lightheadedness, blurry vision, decreased concentration and fatigue were not reported by the MD as symptoms of papillitis; the physician recorded the onset of papillitis as 9/28/01 PM. The pt recorded that he had no fever, focal weakness, dysesthesias, urine or stool incontinence, headache, stiff neck, dysphagia, nausea, vomiting or seizure-like activity. The pt was treated with acyclovir, ceftriaxone and acetylsalicylic acid 325mg daily. He received levofloxacin (Levaquin) 500mg daily for an unspecified number of days; it was discontinued 4 days after discharge from the hospital when Bartonella henselea serologies were reported as negative. He also received 1 injection of benzathine penicillin 2.4 million units; this was "not re-administered given the negative peripheral syphilis serologies". During the hospitalization, the visual acuity in the left eye decreased from 20/20 to 20/60. "He had no fevers, no headaches and no other visual changes during his stay". The pt was discharged to home in stable condition on 10/6/01. Discharge dx was "Bilateral papillitis, left greater that right". In the submission to VAERS, the vaccine provider reported the dx as "Bilateral optic neuritis thought to be vaccine associated". The most recent information was received on 10/22/01. The physician reported that the pt was seen as an outpt on 10/12/01. At that time, the pt "noted some very minor improvement in visual acuity". The physician stated, "no further specific treatment or testing was warranted at that time". The pt remained under the care of an ophthalmologist and the PCP. There were no known adverse experiences following receipt of prior immunizations and no known illnesses at the time of immunizations. Y Y 5 N 08/31/2001 09/28/2001 28 6/15/01-serologies for Hep-A, Hep-B surface antigens and Hep-C were neg; 8/31/01-CD4 cell county was 570 cells/cu mm and viral load was 72,000 copies/mL; Visual fields-left sided monocular scotoma in the inferior part, diffusely blurred disk margins in both pupils; "modest" lymphadenopathy bilaterally in the neck; "Initially ESR-"mildly" elevated at 47mm/hr, repeat-21mm/hr; LP-"notable" CSF opening pressure 19mmH20 and protein of 47mg/dL; CSF glucose-57mg/dL; Cytology-neg for malignant cells; Blood and urine cx-neg; Hep-A serostatus 10/5/01-(+), Hep-B surface antigen-neg; MRA and MRI of head showed "no vascular changes"; MRI of orbits-nml PUB OTH atorvastatin (Lipitor) 20mg daily; testosterone gel (Androgel) NONE HIV since 1987; hypercholesterolemia; hypogonadism; allergy to sulfamethoxazole/trimethoprim (fever). He experienced "generalized wasting as a medication side effect" while taking "four NRTIs plus efavirens" to treat the HIV. Surgical: appendectomy 20010237502 1
0176479 10/19/2001 WI 4.0 4 M 10/12/2001 Pt developed malaise, vomiting and fever starting on 8/9/01. Had some neck stiffness. Y 5 Y 08/03/2001 08/09/2001 6 CSF culture-neg for viral and bacterial; LP-WBC-243 (71 segs, 29 lymphs, (-) gram stain, Proteins-55, glucose-70). PVT PVT NONE NONE NONE 1
0176480 10/19/2001 KS 37.0 37 F 07/19/2001 On 7/17/01, 15 minutes, post vax, pt states she was nauseated and within 4 hours she was dizzy and fatigued. Seen at ER at 13:00. Pulse rate was 64 and she complained of dizziness. Did not return to work on 7/17/01 PM or 07/18/01. On 7/19/01 she went to work. Reports difficult breathing. EMS was called and she was admitted to the hospital. Y Y 2 Y 07/17/2001 07/17/2001 0 Chem 26; TSH; SGOT; SGPT; CXR; Chem 26 #2-all labs-WNL PUB PUB Prozac 20mg daily NONE NONE KS200128 1
0176481 10/19/2001 KS 1.0 0 1 F 07/02/2001 Pt developed redness at injection sites on arms shortly after injections. Approx. 20:00, she became feverish, lethargic, unresponsive but not unconscious. She also became "stiff". Parent reports fever of 102F. EMS crew reported fever of 102.7F. ER recorded her fever at 100.2F to 100.5F. She had 89% O2 sats, retractions. She was taken to another hospital and seen. O2 per tent at 30%. Hydrocortisone 50mg was injected IV. She was given fluids and observed over night. Dismissed at 12:00 on 6/24/01. Diagnosed with allergic reaction to immunizations. Y Y 1 Y 06/23/2001 06/23/2001 0 NONE PUB PUB Tylenol before vaccines were given. Felt warm NONE KS200125 1
0176482 10/19/2001 KS 1.0 0 1 F 08/15/2001 Patient received immunizations at approximately 10:00 am. The patient was given Tylenol several times. The babysitter called the mother to report a temperature of 103F. The mother took the patient to the ER where she was instructed to continue giving the Tylenol and keep and eye on her until her temperature comes down. Y Y 08/14/2001 08/14/2001 0 NONE PUB PUB Tylenol NONE NONE KS200135 1
0176483 10/19/2001 KS 4.0 4 M 08/07/2001 Evening of vaccination, the mother observed hives on the patient's face, abdomen and bilateral extremities. Mother took the patient back to the clinic and was advised by Dr to treat with Benadryl and report back after treatment. U 08/06/2001 08/06/2001 0 PUB OTH NONE NONE KS200132 1
0176484 10/19/2001 KS 1.4 1 .4 F 06/29/2001 Mother states 3 hours post vax the patient developed a rash around the injection site. The patient developed a fever of 102.7F. The patient was treated with ice to the injection site and with Tylenol. Two days post vax the rash had resolved and the fever was gone. The patient remained fussy for two more days, but no other complaints. Y 06/27/2001 06/27/2001 0 NONE PUB PVT NONE NONE NONE KS200126 1
0176485 10/19/2001 KS 0.16 0 .2 M 07/17/2001 Post vax that evening the patient had a temperature of 105F with no other symptoms. The patient was seen in the ER where he had a convulsion. The patient was treated with medicine to lower the fever and sent home. Dr will be giving the next set in her office. Y Y 05/07/2001 05/07/2001 0 NONE PUB PUB NONE NONE NONE KS200127 1
0176486 10/19/2001 KS 0.1 0 .2 F 06/29/2001 Approximately 45 minutes post vax, the mother states the patient's face became very red and swollen. There was also redness and swelling on the patient's arms and legs. The patient was seen at the ER and treated with Benadryl. Y Y 06/28/2001 06/28/2001 0 NONE PUB PUB NONE NONE NONE KS200124 1
0176487 10/19/2001 OH 1.3 1 .3 M 10/12/2001 Post vax the patient's right thigh became red, swollen, blotchy looking, and warm to the touch. Y 09/25/2001 09/26/2001 1 PVT PVT NONE NONE 1
0176488 10/19/2001 LA 1.5 1 .5 F 10/12/2001 Post vax the patient cried a lot. The patient was treated with Tylenol. Y Y 06/27/2001 06/28/2001 1 NONE PVT PVT NONE NONE 1
0176489 10/19/2001 NJ 0.3 0 .4 M 10/16/2001 The patient began vomiting 5 hours post vax and became dehydrated. The patient was seen in the ER and was given an IV to rehydrate. Y Y 10/12/2001 10/12/2001 0 PVT PVT Protopic 0.03% topical BID NONE Pyloric stenosis NJ200119 1
0176491 10/19/2001 NJ 24.0 24 F 10/17/2001 Patient began feeling dizzy approximately 1 minute after receiving 0.5cc influenza vaccine. She then felt nausea and light headed. Placed patient in more reclining position with legs up. Gave water, cool cloth and blanket. Patient remained alert and conscious. Fully recovered within 20 minutes. FU phone call 10/17/2001, patient reports no problems. Y 10/16/2001 10/16/2001 0 NONE OTH PVT NONE Denied allergy to eggs and thimersol. 1
0176492 10/19/2001 LA 11.0 11 F 10/12/2001 Pt had pain in right hip. Follow up 10/25/2001: "Reporter states child had onset of cold-like symptoms and then pain in the hip. Physician has xrayed hip/negative. Using tylenol, heat to area. Flu shot given in the right deltoid, no other vaccine at time, not ill at time of vaccine, no history of adverse events in past." Y U 10/08/2001 10/09/2001 1 Sed rate 27 (normal 0-20) CBC wnl PVT PVT Insulin Diabetes 1
0176493 10/19/2001 TX 1.3 1 .2 F 10/12/2001 Within the first 24 hours after vaccination the site was erythema, and swelling with blisters. The swelling continued for 3-4 days. Y 10/01/2001 10/03/2001 2 PVT PUB PPD 1
0176494 10/19/2001 PA 3.8 3 M 10/09/2001 Post vax, the patient developed erythema, induration, warmth and tenderness in an area 6x8cm at the injection site. Y 08/20/2001 08/28/2001 8 NONE PVT PVT NONE NONE 1
0176495 10/19/2001 KS 13.0 13 M 09/26/2001 School nurse reports that patient complains of wheezing, dizziness, chilling, difficulty breathing, weakness, and shaking. The patient's BP is 119/58; P-58, Temp 100.7. Patient's mother was called and states the patient did not have a reaction to previous HepB vaccination. Patient was seen at clinic and diagnosed with a sinus infection which is being treated with Zithromax. Y Y 09/24/2001 09/24/2001 0 OTH PUB NONE Undiagnosed sinus infection asthma, allergic to penicillin, sulfa, and amoxicillin KS200143 1
0176496 10/19/2001 KS 1.0 1 .0 F 09/14/2001 Patient was seen on 06/22/2001 for a diaper rash. The patient had a fever. During the examination the patient had a seizure that lasted approximately 2 minutes. The fever was 103.1R. After the seizure the patient cried and then slept. Y 06/14/2001 06/22/2001 8 Cathed UA - P#6 spgs 1.010 Blood tr Hemolyzed Protein tr leuko small UC-negative PVT PVT Lotrimin AF vaginal yeast infection NONE KS200141 1
0176497 10/19/2001 KS 4.0 4 M 09/13/2001 Approximately 12 hours post vax the patient was shaking and vomiting. Patient was seen at the ER later that morning, was treated with Amoxicillin for 10 days, a throat culture was done and blood was drawn. Y Y 09/11/2001 09/12/2001 1 PUB PUB PPD skin test negative NONE NONE KS200142 1
0176498 10/19/2001 KS 5.0 5 M 08/27/2001 Post vax the patient developed a fever of 102.6F on 08/15/2001. The patient still had the fever 08/17/2001. Patient's mother stated patient feels fine on 08/20/2001. Y 08/15/2001 08/15/2001 0 PUB PUB NONE KS200137 1
0176499 10/19/2001 KS 4.0 4 F 08/20/2001 Post vax the patient's left arm was red and swollen at the injection site , approximately 3cm diameter. Y 08/13/2001 08/15/2001 2 PUB OTH NONE NONE NONE KS200136 1
0176500 10/19/2001 KS 5.0 5 M 08/13/2001 45 minutes post vax, the patient complained of itching and swollen eyes. The patient's mother reported being able to see his glands. Motrin and Benadryl were given. Y Y 08/10/2001 08/10/2001 0 NONE PUB PUB NONE NONE KS200134 1
0176501 10/19/2001 KS 5.0 5 F 08/06/2001 Post vax, 5" x 5" red rash was noted by the patient's mother. The rash feels warm to the touch. There are no other symptoms mentioned. Y Y 08/03/2001 08/05/2001 2 NONE PUB PUB PPD NONE NONE KS200131 1
0176502 10/19/2001 KS 2.0 2 .1 M 07/27/2001 Post vax, the patient leg showed redness in an intermittent pattern with some swelling in an area about 10". Y 07/23/2001 07/23/2001 0 NONE PVT PVT NONE Sunburn blisters to arms NONE KS200130 1
0176503 10/19/2001 KS 44.0 44 F 07/23/2001 About 4 days post vax, the patient attempted to dance and her legs gave out. The next morning the patient was unable to get out of bed. The patient complained of severe joint pain with inflammation. Saw Dr and was referred to a specialist. Diagnosed with rheumatoid arthritis. Patient states she has eye problems also. Y U 12/04/1997 12/08/1997 4 sedimentation rate PUB PVT NONE NONE NONE KS200129 1
0176504 10/19/2001 KS 14.0 14 F 06/28/2001 The patient receieved the vaccination at approximately 11:30. At 5 p.m. the patient's feet felt numb and her feet and hands felt edematous. The patient had hives on her hands and lower arms and also on her feet and lower legs. The patient was treated with Benadryl. The patient was also treated with Pulmicort aerosol for breathing difficulties. Y 06/26/2001 06/26/2001 0 NONE PUB PUB Singulair, Guaifeneson, Abluterol, Serevent, and pulmicort Asthma, Allergic to MMR pertussis, and sulfa Severe rash and fever~Measles + Mumps + Rubella (MMR II)~1~1.30~In Patient KS200123 1
0176506 10/19/2001 MA 4.0 4 M 08/22/2001 Post vax the patient developed severe swelling and redness of the upper arm. Y 07/24/2001 07/24/2001 0 NONE PVT UNK NONE NONE Allergic to Ziac-oxide, soy and sweet potatoes. 1
0176507 10/19/2001 LA 1.9 1 .9 M 10/11/2001 The patient's mother reports a rash started 2 hrs after the vax. The patient was seen in the ER with an urticarial rash which was treated wtih DepoMedrol and Benadryl. On 10/10 at office visit, patient still covered with urticarial lesions. The patient was placed on Orapred, Benadryl and Calamine Lotion. On 10/11 the mother of the patient states the rash is improved. Y Y 10/09/2001 10/09/2001 0 NONE PVT PUB Xopenex, Claritin, Cefzil BOM, RAD, URI Asthma 1
0176508 10/19/2001 NY 18.0 18 F 10/12/2001 Post vax on 10/06/2001 the patient developed a fever, sore throat, and swollen glands. On 10/11/2001 the patient developed a petichael rash on her face and neck. N 09/26/2001 10/06/2001 10 OTH UNK NONE NONE NONE 1
0176509 10/19/2001 OH 5.0 5 M 10/15/2001 Post vax the patient developed very swollen eyelids. The patient was treated with Benadryl and a cool compress and sent home. Y 10/12/2001 10/12/2001 0 NONE PVT PVT NONE NONE Down's Syndrome, mitral insufficiency, s/p AVSD 1
0176510 10/19/2001 NC 27.0 27 M 10/15/2001 Post vax the patient developed a rash on the torso area only. U 09/24/2001 09/25/2001 1 PVT PVT NONE NONE NONE 1
0176511 10/19/2001 TX 4.0 4 U 10/12/2001 Post vax the injection site has erythema, swelling and is tender. The site has remained swollen and tender for 3 days. Y 10/08/2001 10/10/2001 2 PVT PUB 1
0176512 10/19/2001 CA 1.4 1 .5 F 10/18/2001 Post vax, the patient's thigh became swollen, with a large area of induration, warmth and mild pain. Y Y 10/11/2001 10/12/2001 1 NONE PVT PVT NONE NONE 1
0176513 10/19/2001 ND 31.0 31 M 10/02/2001 Post vax the patient had a skin reaction with erythema at the injection site in an area 4x6cm. Y 09/25/2001 09/26/2001 1 NONE UNK UNK 1
0176514 10/19/2001 WI 5.0 5 F 10/10/2001 The day following vaccination the patient's mother took temperature and it was 102F. The patient's temperature was off and on during the day. The patient also complained of no appetite, nausea, and vomiting. The patient was treated with Benadryl. The mother noted there was redness and hardness at the injection site. Y 10/08/2001 10/09/2001 1 PUB PUB NONE NONE NONE 1
0176515 10/19/2001 KS 14.0 14 M 09/12/2001 After receiving vaccination, the patient turned pale and fainted within 30 seconds of shot. The patient recovered within 30 seconds and was alert, but noticed nausea. Y 09/12/2001 09/12/2001 0 NONE PUB PUB NONE NONE NONE KS200139 1
0176516 10/19/2001 KS 4.8 4 M 09/11/2001 Approximately 8 minutes post vax, the patient's mother noted a rash on the upper part of the patient's face. The rash appeared as red pinpoint dots. There was no rash noted on any other body parts. The patient was advised to seek medical attention. U 09/11/2001 09/11/2001 0 NONE PUB OTH PPD NONE NONE KS200140 1
0176517 10/22/2001 MO 1.5 1 .4 F 12/10/2001 Information has been received from a consumer concerning her daughter who in approx. 4/95, at 18 months of age, was vaccinated with MMRII and subsequently, her daughter developed the "symptoms associated with autism". It is noted that she has speech problems, physical problems, only weighs 44 pounds and is in special education classes in school. It was reported that she cannot afford to have the testing done to officially confirm that she has autism. Unspecified medical attention was sought. It was noted that the pt is currently on therapy with loratadine (Claritin). Follow up information from a woman in a physician's office indicated that the child first visited the office in March 2000 for shingella when she was 6 years old. It was noted that she visited the office a second time, also for shingella. On 2/16/01 the child had a well visit with the physican and the question of autism was raised. The mother reported to the physician that the child was seen several times by a neurologist and, at that time, they had not diagnosed the child with autism. It was reported that the mother requested a referral to another neurologist, but that the child had never returned to his office since 2/16/01. It is unknown if the child was ever seen by another neurologist. Shingella was considered an incidental finding. Upon internal review, Autism was considered an "Other Important Medical Event". Additional information has been requested. F/U information from a woman in a physician's office indicated that the child 1st visited the office in 3/00 for shigella when she was 6 years old. It was noted that she visited the office a 2nd time, also for shigella. On 2/15/01, the child had a well visit with the physician and the question of autism was raised. The mother reported to the physician that the child was seen several times by a neurologist and, at that time, they had not dx'd the child with autism. It was reported that the mother requested a referral to another neurologist, but that the child had never returned to his office since 2/16/01. It is unknown if the child was ever seen by another neurologist. Shigella was considered an incidental finding. Upon internal review, Autism was considered an "Other Important Medical Event". Additional information has been requested. Y N 04/01/1995 Body weight measurement-44 lbs OTH OTH Claritin Cardiac disorder, drug allergy, bradycardia, sleep apnea. WAES01100742 1
0176518 10/22/2001 MN 0.2 0 .2 M 10/15/2001 Irritability developed and approximately 48 hours after vaccines. 4 days after vaccines developed fever, elevated irritability and lethargy. A complete sepsis evaluation done and admitted for IV antibiotics. All cultures negative. Fever resolved 48 hours later. Y 3 Y 10/08/2001 10/12/2001 4 Blood culture; Urine culture; CSF culture-all negative; WBC-3800 (64S; 22L; 11M) PVT PVT NONE NONE but dad and sister developed fever X 1 day between time of vaccines and onset of fever in pt. 1
0176519 10/22/2001 NJ 0.2 0 .1 M 10/13/2001 Vaccines-DTaP, IPV, Comvax, (Hep/HIB), Prevnar given 10/10. Irritability began 10/11 AM, temp 99.6 - 99.8. Injection sites erythema. Decreased feeding and worsening irritability 10/12. Bouts of high pitched crying and refused to feed with decreased urine output. Hospitalized to r/o sepsis on 10/13- CBC, lytes, U/A - Nml, CT head - Neg. Baby did well and began feeding and sleeping. Y Y 1 Y 10/10/2001 10/11/2001 1 10/13- CBC, lytes, U/A - Nml, CT head - Neg. PUB PUB NONE NONE NONE 1
0176520 10/22/2001 AZ 2.2 1 .0 M 10/09/2001 After his 12 month shots, he lost all language and all eye contact and could not respond to any noise or even waving in front of his face. He still has no language and no receptive response. He has some eye contact but does not respond or react to people but is getting a little better at times. Called 911 and EMS came. Called because he was very hot with temperature of 106F and then 104F after trying warm towel and bathing in small tub of water but didn't work out. At ER he arched his head all the way back, was stiff and eyes rolled and looked very bad. The dx in ER was viral syndrome (fever of unknown origin) and possible seizure. Diagnosed with Global Developmental Delay. Y Y N 07/17/2000 Abnormal peptide (urine test); increased levels of IAG have been related to the symptoms of autism and other behavioral disorders PVT OTH NONE NONE NONE 1
0176521 10/22/2001 NY 41.0 40 F 10/10/2001 Pt developed a vise-like headache, nausea, photosensitivity, hypotension, shaking rigors and dizziness. Symptoms persisted for 4 hours. Pt was given Benadryl X 2 doses in office. Dx'd with depressed immune system. Y Y N 07/20/2000 07/20/2001 365 PVT UNK NONE hyperglycemia 1
0176522 10/22/2001 KY 1.3 1 .3 M 10/16/2001 24 hours after receiving the injection the patient has an area of erythema and edema the size of a lemon. The tissue is firm at the sight. Y 10/15/2001 10/16/2001 1 PUB PUB NONE NONE NONE KY2001077 1
0176523 10/22/2001 MI 1.0 1 .0 F 09/04/2001 Post vax the patient had a seizure that lasted approximately 1 minute. No known temperature recorded. Y U 05/29/2001 05/30/2001 1 EEG-normal; blood test, urine analysis, chest x-ray=all normal; CT scan - negative PVT OTH 1
0176524 10/22/2001 MA 1.5 1 .5 M 10/15/2001 Post vax, the patient had brief apnea, trouble breathing and a temperature of 103-104F. Y 09/26/2001 09/27/2001 1 NONE PVT UNK NONE 1
0176525 10/22/2001 PA 0.3 0 .3 F 10/09/2001 The patient had two seizures in the car on the way home from the clinic approximately 35 minutes after receiving vaccine. Y Y 08/28/2001 08/28/2001 0 Seen by pediatric neurologist. PUB PUB NONE NONE PA0157 1
0176526 10/22/2001 PA 4.8 F 10/05/2001 Post vax, on 08/01/2001 the patient started with a fever of 103F. The patient was treated with Advil. The patient also had a headache and congestion. On 08/03/2001 the patient had swollen feet and a rash. The patient was referred to a MD. The next day the rash was gone and the child was OK. Y Y 08/01/2001 08/01/2001 0 NONE PUB PUB NONE NONE NONE PA0158 1
0176528 10/22/2001 MI 0.4 0 .5 F 08/21/2001 Mother states patient has fever of 104F. The pediatrician did blood work and the results are pending. Y Y 08/20/2001 08/21/2001 1 PUB PUB Infant Tylenol NONE NONE MI2001080 1
0176529 10/22/2001 SC 1.0 1 .0 M 10/15/2001 The patient's injection site on his left thigh began swelling and turning red around midnight. The redness and swelling covered an area approximately 1 1/2"-2" in diameter. A rash was also starting, worsening with a fever around midnight. The patient was seen in the ER. Y N 10/12/2001 10/13/2001 1 NONE PVT PVT Dimetapp, Motrin Mild rhinitis, a few erythematous papules 04/13/2001~DTaP (no brand name)~3~0.50~In Patient|~Polio Virus, Inact. (no brand name)~3~0.50~In Sibling|~Pneumo (Prevnar)~3~0.5 1
0176530 10/22/2001 NJ 54.0 F 10/19/2001 Reportedly, within one week of the vaccination, the patient experienced head throbbing and pressure. The patient stated that her physician told her that her symptoms were not related to the vaccination. In late June 2000, the patient reportedly received her second injection. The patient stated that the head throbbing and pressure were ongoing at the time the second injection was administered. One week after the second injection, her symptoms increased in severity and the patient began to experience ringing in her ears. The patient also reported that she began experiencing exhaustion, extreme anxiety, depression, hypertension and elevated cholesterol. The patient stated that her blood pressure increased from 120/70 to 190/100. The patient's primary physician prescribed an antihypertensive medication which she took for 1 to 2 months. Reportedly, after this treatment, the patient's blood pressure returned to normal and the medication was discontinued. The patient's cholesterol increased from 180 to 268. The patient was treated with Lipitor for approximately 2 months, after which her cholesterol returned to 180. The patient was also treated with Xanax, which reportedly had no effect. The patient was seen by an ear specialist who made a diagnosis of tinnitus. This specialist declined to treat the patient. The patient was seen by a nutritionist, who reportedly treated the patient with herbs. There was no effect on her symptoms. The patient was seen by a neurologist who prescribed Paxil. The patient was seen by a gynecologist who prescribed Loestrin, Xanax and an unspecified medication for bloating. These medications reportedly had no effect. The patient was seen by a psychiatrist, who increased the Paxil dosage. This medication change had no effect. The patient was then seen by a homeopath whose conclusion was "bacteria in the system and either Lyme disease or a reaction to Lymerix". The patient was treated by stopping all medications and starting vitamin supplements to "detox the system". The patient stated that she felt somewhat better within 2 weeks. The patient was then seen by an infection control physician who found she had symptoms of Lyme, but that it could not be proven. The patient then returned to her primary physician, who reportedly informed her that her symptoms were without a doubt a reaction to the vaccine. As of 10/04/2001, the patient stated that the head throbbing and pressure, tinnitus, exhaustion, anxiety, and depression persisted, but have been milder since treatment by the homeopathic physician. The elevated cholesterol and hypertension had resolved. Y Y 06/01/2000 MRI = wnl, test for Lupus = negative, Autoimmune test = negative, Lyme test = wnl. PUB OTH NONE NONE NONE 20010243141 1
0176531 10/22/2001 NH 60.0 60 F 10/16/2001 The patient experienced cramps and diarrhea within the first 24 hours after the vaccination, lasting approximately 48 hours. Y 10/02/2001 10/03/2001 1 NONE OTH OTH Lotension, Inderol, Synthroid and Liptor. NONE Hypertension, unactive thyroid. 1
0176532 10/22/2001 MA 7.0 6 F 10/16/2001 Child developed local reaction to flu vaccine beginning the following morning after injection. Reaction site increased in size to "baseball" size on deltoid. No symptoms of abscess. Child brought to office on third day after injection. Follow up 10/25/2001: "Child had no other vaccines at this visit. No other vaccines in prevous 4 weeks, on no medication, no history of previous adverse events." Y Y 10/12/2001 10/13/2001 1 PVT PUB NONE Reactive Airway Disease 1
0176533 10/22/2001 MA 73.0 73 F 10/18/2001 On 10/16/2001 vaccine given, originally no reaction noted. On 10/17/2001 about 1/2 inch localized pink area with edema and slightly warm to touch. Warm compress applied. Y 10/16/2001 10/17/2001 1 NONE UNK UNK Had reaction to neurotin. Back surgery 1
0176534 10/22/2001 MA 87.0 87 M 10/18/2001 On 10/16/2001 vaccine given, originally no reaction noted. On 10/17/2001 about 1/2 inch localized pink area with edema and slightly warm to touch. Warm compress applied. Y 10/16/2001 10/17/2001 1 NONE OTH UNK Alverone, BP meds, Coumadine NONE Had a cold about 2 weeks prior to vaccine. 1
0176535 10/22/2001 MA 55.0 55 F 10/18/2001 On 10/16/2001, vaccine given, no reaction. On 10/17/2001 had a one and one-half inch red, slightly swollen and slightly warm reaction. Instructed to take Benadryl and put warm compresses. Did not do. On 10/18/2001 red area increased to about 2.5 inches of redness and slightly warm to touch. Instructed again to take Benadryl. Y 10/16/2001 10/17/2001 1 NONE OTH UNK NONE UNK 1
0176536 10/22/2001 MA 57.0 57 F 10/18/2001 Originally had no reaction given on 10/16/01. On 10/17/01, area became red, swollen, warmth n4" in diameter. On 10/18/01 decreased redness and warmth putting Benadryl cream on left arm. Y 10/16/2001 10/17/2001 1 NONE OTH UNK NONE NONE UNK 1
0176537 10/22/2001 MA 57.0 57 F 10/18/2001 Given vaccine left deltoid, c/o itchiness, then became red, approximately 3" area of edema and warm to touch on 10/17/01. Reaction increased in size, approximately 6" red area, swollen and warm. Put cool - warm compresses and took Benadryl. On 10/18/01 decreased redness and warmth. Y Y 10/16/2001 10/16/2001 0 NONE OTH OTH NONE Latex sensitivity 1
0176538 10/22/2001 NH 47.0 47 F 10/16/2001 Cramps. Diarrhea, within 24 hours and lasted about 2 to 5 days. Y 10/01/2001 10/02/2001 1 NONE OTH OTH Lotenseon prem; pro NONE hypertension 1
0176539 10/22/2001 NM 23.0 23 F 10/10/2001 Influenza administered right arm; 2 inch radius around shot, red blotched and hot with touch. Arm all the way to hand tingles (next day at 1600). Y 10/09/2001 10/09/2001 0 MIL MIL 1
0176540 10/22/2001 PA 66.0 66 F 10/13/2001 Pt developed nausea vomiting SOB within 24 hours of receiving influenza shot Y U 10/12/2001 10/13/2001 1 CBC lytes gln Buw Normal OTH OTH Synthroid, Librax NONE hypothyroidism, anxiety 1
0176541 10/22/2001 MO 54.0 54 F 10/12/2001 Pt got myalgia, fever 24 ph after vaccine. By noct am, edema, erythema and warmth at injection site. by 4-5 days. Y 10/08/2001 10/09/2001 1 NONE PVT UNK Zanax wabab, Estrogen, Darvon Ma Ml NONE 1
0176542 10/22/2001 NJ 27.0 27 F 09/14/2001 The pt described sensation of B/L finger swelling and shaking. No erythema, edema or bruising noted at injection site. Symptoms abated. Y 10/13/2001 10/13/2001 0 MIL MIL NONE NONE 1
0176543 10/22/2001 MI 39.0 39 F 09/27/2001 The pt's skin felt itchy all over the day after immunization, followed by scattered hives, which persisted into the second day post vax. When the client took Benadryl the discomfort was reduced and the client notified private provider. Y 09/24/2001 09/25/2001 1 PUB UNK allergy to Ceflex MI2001081 1
0176544 10/22/2001 PA 48.0 37 F 10/14/2001 The pt experienced redness, swelling from shoulder to fingers (about twice its normal size). This started approximately 1 day post vax lasting several days. Treated with hydrocortisone cream and elevation. Y Y 01/11/1991 01/12/1991 1 NONE MIL MIL NONE NONE allergy to ampicillin 1
0176545 10/22/2001 VA 4.0 4 M 10/15/2001 Post vax on 10/12/2001 the patient was feverish. The patient's left leg was red, indurated and sore. The pediatrician advised cold compresses, Tylenol, Advil and Benadryl. On 10/15/2001 the patient's leg is improved but still has a large hard area about 3" x 3". Y 10/11/2001 10/12/2001 1 PUB UNK NONE NONE 1
0176546 10/22/2001 MI 1.0 1 .0 M 10/02/2001 Two days post vax, the patient developed a full body rash. The rash was bright pink with distinct lesions. The patient's mother reports the patient had a fever for 4 days. Y Y 09/25/2001 09/27/2001 2 PUB PUB NONE NONE NONE MI2001082 1
0176547 10/22/2001 MI 42.0 41 F 10/02/2001 Post vax on 07/19/2001 the patient experienced pain in her left arm. By 07/20/2001 the patient was unable to lift her arm above should level. There is no local redness or swelling. The patient has been seen by a chiropractor 6-7 times since August. The patient is being treated with exercises and heat. The patient feels the arm is worsening. Y N 07/16/2001 07/19/2001 3 NONE PUB PUB NONE NONE NONE MI2001079 1
0176548 10/22/2001 CO 1.0 1 .0 M 10/04/2001 One month post vax the patient developed protracted emesis. There was no fever or rash. The patient became atoxic (clumsy) 3 days later. There was no evidence of Otitis Media when seen by the ENT. Symptoms resolved 09/30/2001 per mother. Y 07/25/2001 08/22/2001 28 Head CT-wnl; PVT PVT NONE NONE NONE 1
0176549 10/22/2001 OR 1.3 1 .3 F 10/15/2001 Nine days post vax, the patient developed a macular red rash. The rash has persisted for 3 days. U 10/05/2001 10/14/2001 9 PVT PVT NONE NONE 1
0176550 10/22/2001 PA 33.0 33 F 10/05/2001 Post vax the patient's left upper arm above the elbow is swollen and hot the touch. The area is starting to appear bruised. The patient is being treated with Tequin. Y U 10/02/2001 10/02/2001 0 PUB PUB Triphasil NONE NONE PA0156 1
0176551 10/22/2001 GA 46.0 46 F 10/16/2001 Post vax the patient developed itching with skin eruptions, hives, congestion, a temp of 100.1, swelling lips and swelling eyes. The patient was treated with Vistaril, SoluMedrol, Atarax, and Prednisone. Y U 10/01/2001 10/13/2001 12 CBC - Electrolytes - CMP OTH OTH Relafen, Zyrtec, Vitamins NONE Allergic to Ceftin, Codeine, Benadryl, Augmentin and Thorazine. 1
0176552 10/22/2001 MN 65.0 65 F 10/15/2001 Post vax the patient had a severe local reaction, with swelling, erythematous, tender upper arm approximately 10x20cm. The patient was treated with diphenhydramine and NSAIDS. Y Y 10/04/2001 10/05/2001 1 NONE PVT UNK Oxybutinin NONE NONE 1
0176553 10/22/2001 PA 65.0 65 F 10/15/2001 Post vax, the patient complained of redness and soreness around the injection site. U 10/09/2001 10/10/2001 1 PVT OTH Sore throat, cough CAD, HTN, Breast CA 1
0176554 10/22/2001 OK 6.0 1 .5 F 10/15/2001 The patient was diagnosed with chickenpox on 10/15/2001. The patient received vaccine on 11/26/1996. Y 11/26/1996 10/14/2001 1783 NONE PVT PVT 1
0176555 10/22/2001 PA 7.0 1 .5 M 10/15/2001 On 10/11/2001 50 pox were noted on various body parts. Y 08/07/1995 10/11/2001 2257 NONE PVT PVT NONE NONE NONE 1
0176556 10/22/2001 CA 2.0 2 .3 M 10/12/2001 The patient's left leg developed a large erythema area, warm to the touch due to vaccination. U 10/09/2001 10/10/2001 1 NONE PVT PVT NONE 1
0176557 10/22/2001 MA 1.4 1 .4 F 10/16/2001 On 10/10 a rash was noted on the patient. On 10/11/2001 the rash increased with itchy eyes. The patient was treated with Benadryl. The patient was seen in the office which revealed red macular papular lesions on the face and trunk. On 10/12/2001 the rash was improved. Y Y 10/02/2001 10/10/2001 8 PVT PUB Bactrim UTI Hemangioma 1
0176558 10/22/2001 OK 2.0 2 .1 F 10/16/2001 The patient experienced generalized urticaria and pruritis for a 2 week period. U 09/28/2001 09/30/2001 2 NONE PVT PVT NONE NONE NONE 1
0176559 10/22/2001 NY 41.0 41 F 10/15/2001 The patient experienced severe arm pain, hives and a fever one day after immunization, worsening the next day. The patient was treated with Medrol dose pack, Benadryl, Tylenol and cool compresses. Y 10/13/2001 10/14/2001 1 PVT PVT Martoux PPD NONE Uterine fibroids and fibrocystic breasts 1
0176560 10/22/2001 MN 83.0 83 M 10/16/2001 Patient complained via telephone on 08/30/2001, of a "large local reaction". The patient was advised to treat with an ice pack. The patient went to the ER on 09/02/2001 and was diagnosed with cellulitis. Augmentin was prescribed. Y Y 08/28/2001 08/30/2001 2 Temp 35.9C/Chem 8-WNL/Sed Rate above 46 PVT PVT MVT, Minerals NONE Eczema with history of skin cancer. 1
0176561 10/22/2001 TX 3.0 3 M 10/16/2001 The patient developed bilateral ankle effusions/arthritis, 2 days after vaccination. Y Y 09/28/2001 09/30/2001 2 CBC, ANA, Complement, A 80, RA, UA all negative. Sed rate was 20. PVT PVT NONE URI NONE 1
0176562 10/22/2001 IA 55.0 55 M 10/11/2001 The patient states his left arm started itching last night, then reddened and was warm. The patient's left arm now feels stiff. Y U 10/02/2001 10/10/2001 8 PVT PVT Vitamin, ASA Stepped on nails, both feet 1
0176563 10/22/2001 NY 19.0 19 M The patient complained of a "woozy feeling". When examined there were no signs of an allergic reaction. The "woozy feeling" abated with no treatment necessary. Y 10/14/2001 10/14/2001 0 NONE MIL MIL PPD NONE NONE 1
0176564 10/22/2001 CO 4.0 4 M Post vax the patient experienced scrotal swelling and tenderness, possible orchitis. Y Y 08/17/2001 08/30/2001 13 Ultrasound of scrotum - normal PVT PVT NONE NONE NONE 1
0176565 10/22/2001 MA 1.0 1 .1 F 10/11/2001 On 10/10/2001 the patient developed a low grade fever with inguinal nodes. On 10/11/2001 follow up by phone, the patient is doing better, the fever is down, but the patient still has inguinal nodes. Y 10/02/2001 10/10/2001 8 NONE PVT PUB NONE NONE 1
0176566 10/22/2001 MI 4.0 4 M 10/01/2001 Three hours post vax, the patient began not focusing at preschool, not listening, standing up and throwing chairs, screaming, and running around the room yelling. Y 09/19/2001 09/19/2001 0 NONE PVT OTH NONE NONE NONE 1
0176567 10/22/2001 NH 2.0 1 1 F 10/15/2001 A few days after receiving vaccination, the patient's mother noted a small area of redness and vesicles around the injection site. When examined in office, the patient had a 2" area of erythema, indurated, tender with papules. The patient also had otitis media. The patient was treated with Bactroban and Benadryl. U 10/05/2001 10/07/2001 2 NONE PVT PUB Cefzil LOM NONE 1
0176568 10/23/2001 AR 0.4 0 .5 M 10/18/2001 Unsure if related to vaccines. Mother reports fever, being more tired than usual and 3 or 4 episodes of diarrhea on 10/16/01. Dad checked on infant in evening and found him not breathing and noticed blood from mouth. Mother was at work. Infant was alone in parents bed. COD as per autopsy report: Lymphoplasmacytic Meningitis. Y 10/16/2001 N 10/15/2001 10/16/2001 1 Autopsy to be done. PVT PUB NONE NONE 6 weeks premature; hypospadias; head asymetric; history or GE Reflux 1
0176571 10/23/2001 CA 30.0 30 F 10/18/2001 Information has been received concerning a 30 year old white wife who on 7/2/00 was vaccinated with 1 dose of varicella virus vaccine live (site unknown). On 9/6/00, it was confirmed that she is 9 1/2 weeks pregnant (LMP: 7/5/00). Follow-up information from the consumer noted that the pt had the baby on 4/8/01. Additional information received from the consumer noted that the pt had been tested for varicella antibodies before vaccination in 2000 and the results were negative. In approx. 9/00, the pt developed nausea and was started on therapy with metoclopramide hydrochloride (Reglan) 10mg, the number of doses taken was noted to be "at first 5 and then 2". The metoclopramide hydrochloride (Reglan) was stopped on 4/8/01. On an unknown date, the pt had a positive test for alpha fetoprotein. At "around 20 weeks" the pt had the amniocentesis done that was normal. The amniocentesis was performed because the pt had the positive alpha fetoprotein test and then had the test retaken and had a negative test result. It was noted that the pt delivered pre-term at less than 37 weeks gestation on 4/8/01, a normal male weighing 4 lbs and 11.6 oz. The pt did not have any complications during labor/delivery and there were no concurrent medical conditions. The pt did not have a local reaction at the vaccination site and there were no symptoms of varicella or herpes zoster. Follow-up information from the pt's medical records noted that the pt was hospitalized twice for hyperemesis and treatment with unspecified medications (dates not specified). The pt's LMP was noted to be 7/23/00 (previously reported as 7/5/00) with an EDD of 4/30/01. On 2/26/01 and 3/12/01 it was noted that the pt was "doing well". It was noted on an unspecified date, that the pt was to start "NST" regarding an increased alpha fetoprotein test early in pregnancy. No further information is available. A follow up report received 12/27/2001 adds: Follow-up info from an office manager in a physician's office stated that their records do not indicate that the pt received (varicella virus vaccine live) under their care but it had been reported by another physician earlier in the pregnancy as the pt transferred to this office late in the pregnancy. It was confirmed that the hyperemesis had resolved as the pt had delivered. No further info is available. Y Y Y 07/02/2000 09/01/2000 61 Several ultrasounds were performed due to the high alpha fetoprotein test and nausea and the results were normal. On 3/26/01, it was noted that the pt had a vaginal test that was Group B Beta Strep Positive. PUB OTH NONE Inguinal hernia; surgery WAES00090464 1
0176573 10/23/2001 IN F 12/14/2001 A physician reported that a female child received Prevnar vaccine and subsequently, developed a positive blood culture. Additional vaccines received included DTP and Poliomyelitis vaccine inactivated. The child was admitted to the hospital. The physician stated that the child was treated with an injection of ceftriaxone sodium (Rocephin) in their office. No additional information was available as of the date of this report. Y Y U UNK PVT PVT NONE UNK UNK HQ7192116OCT2001 1
0176578 10/23/2001 1.08 M 10/17/2001 This information was received from a consumer concerning his 13 month old son who was vaccinated with a dose of MMRII, IM, on an unspecified date. On 9/7/01, the child's father alleged that the following events were associated with the use of ibuprofen (Children's Motrin). On an unspecified date, 4 minutes after the ibuprofen was given for fever of 104.3F, his son sat up in his crib, began staring blankly and his eyes rolled back and to the right. The father reported that his son was not convulsing and that he rushed the child to the closest medical facility, while reporting the events to the physician, the child remained in a trance, lifeless and developed cyanosis of the lips, genitals and extremities. The child was immediately treated with oxygen, turned pink and began crying. The father reported that no additional treatment was given and the child was discharged after being stabilized, once the fever improved. According to the parent's report, the physician attributed the event (75%) to a ibuprofen allergy and (25%) to the fever. The following day, the child was taken to the doctor, who reportedly believed that the event was a delayed reaction to vaccination with MMRII, received 3 weeks prior, since there was no increase in his WBC. The child was also taken to a neurologist who performed an EEG and could not attribute the event to ibuprofen or MMRII. The father reported that the neurologist classified the event as a febrile seizure. Subsequently, the pt recovered. Febrile seizure and cyanosis were considered to be "Other Important Medical Events". Additional information is not expected. Y Y EEG-results not reported; WBC-no increase OTH OTH Children's Motrin NONE WAES01100712 1
0176579 10/23/2001 CA 1.4 1 .4 F 10/17/2001 Information has been received from a health professional concerning a 17 month old female who on 9/26/01 was vaccinated with a dose of MMRII (lot 639621/0899L). On 10/4/01, the pt developed a fever of 103.4F, followed by a febrile seizure. The child was taken to the ER. It was reported that she also had "increased respirations, wheezing and congestion, dx'd as secondary to fever". She had a 2nd febrile seizure in the ER. The child was treated with Rocephin. She was admitted to the hospital for less than 24 hours and was discharged on the afternoon of 10/5/01. That day, the pt's mother reported to the doctor's office that the child was "doing well". Additional information has been requested. F/U information received on 11/15/01, from an MA indicated that the vaccination was the pt's 1st dose and that the dose had been administered SC, in the left arm. It was reported that the adverse event onset date was 10/3/01 (also reported as 10/4/01). On 10/4/01, the pt's mother called into the physician's office thinking that the pt had respiratory syncytial virus (RSV). She reported that the pt's sibling had RSV. The pt's mother reported that the child was resting comfortably but in the car, the pt's eyes rolled back, she drooled, her body went limp and she had no body jerks. Medical records received indicated that on 10/4/01, the pt experienced contractions and had a respiratory rate of 40 when asleep. It was reported that the pt's temperature was 103-104F. The pt was treated at an urgent care facility. Motrin was administered and it was reported that the pt improved. A physician reported that the pt's CBC was 12K and that the blood cultures were pending. No distress was noted and a respiratory rate of 30 was recorded. The pt was given Rocephin IM and sent home. The pt was scheduled for a follow-up visit. On 10/5/01, it was reported that the pt was admitted to the hospital on 10/4/01 where a fever of 103.4F was noted. Another seizure occurred while the pt was hospitalized. It was noted that the pt's dx of high fever was secondary to the therapy with MMRII. It was reported that the pt had received a 2nd injection of Rocephin and that her fever decreased, she was alert and she had a normal respiratory rate. It was noted that the pt was to be transferred. It was reported that the pt's experience was resolving on 10/5/01 and that she recovered from her experience on an unspecified date. No further information is available. Y Y 1 Y 09/26/2001 10/04/2001 8 On 10/4/01 CXR-neg; blood cultures-pending; Spinal Tap-neg; Body temp-fever; CBC-12K; RR-40 and then 30 with no distress PVT PVT NONE Ovarian cyst at birth WAES01101112 1
0176582 10/23/2001 AZ M 10/18/2001 Information has been received from a consumer concerning a male pt who was vaccinated with Hep-B vaccine recombinant (yeast) and experienced autism. Unspecified medical attention was sought. No further information was provided. Upon internal review Autism was considered an "Other Important Medical Event". Additional information has been requested. Y N OTH OTH UNK UNK WAES01101098 1
0176585 10/23/2001 NY 4.5 4 F 10/15/2001 Pt developed left arm cellulitis that needed hospital admission with IV antibiotics, 2 days after vaccine administration. The pt had redness and swelling of left upper arm 1 day, post vax. Pt was treated with IV nafcillin on admission. Cefuroxine added to regimen after swelling was noted to increase on 10/15/01. Surgery consult was obtained; nafcillin discontinued; IV clindamycin and vancomysin started with gradual decrease in swelling and erythema with peeling of areas in left upper arm. Seen by Dermatologist on 10/16/01. Y Y Y 10/12/2001 10/13/2001 1 CBC; would culture-neg; varicella culture-neg; Peds blood culture-Staphylococcus epidermidis; Lymph %-12.1(low); Seg %(high) PVT OTH NONE NONE 1
0176586 10/23/2001 FL 15.0 15 M 10/16/2001 Pt developed petechiae on buccal mucosa, trunk and extremities. Referred to ER for evaluation. Y Y 7 Y 09/19/2001 10/04/2001 15 PUB PUB NONE NONE NONE 1
0176587 10/23/2001 IA 4.0 4 M 10/15/2001 Pt presented on 9/24/01 with erythema multiforme. He was admitted to the hospital on 9/25/01 and placed on IV Solu-Medrol. He was discharged home on 9/27/01 with no rash. Y Y 2 Y 09/13/2001 09/24/2001 11 CRP-7.7 PVT PVT NONE NONE NONE 1
0176588 10/23/2001 RI 0.1 0 .2 M 10/17/2001 Two days post vax, the patient developed a reddish brown sandpaper-like rash on bilateral anterior thighs. The patient had no other problems and the rash did not seem to bother him. U 10/12/2001 10/14/2001 2 NONE PVT PVT NONE NONE NONE 1
0176589 10/23/2001 OK 0.6 0 .6 M 10/12/2001 Mother states rectal temp of patient at home is 103F. The patient's temp at the dr's office is 100.8F. The patient's mother states the patient was "acting funny" after getting immunizations. The patient was sent to the hospital for lab work. Over the counter meds were used to reduce the fever. Y Y 10/09/2001 10/10/2001 1 CBC, UA = WNL PVT PUB Diflucan Eczema Eczema 1
0176590 10/23/2001 WI 1.6 1 .6 M 10/12/2001 Post vax the patient broke out with hives on his arms, chest and back. The patient was treated with epinephrine. Y 10/12/2001 10/12/2001 0 PVT PUB NONE NONE 1
0176591 10/23/2001 LA 0.25 0 .2 M 10/14/2001 Post vax the patient was unconsolable, crying, and irritable for approximately 4 hours. Y 09/27/2001 09/27/2001 0 NONE PVT PVT Nasal Congestion NONE 1
0176592 10/23/2001 IN 0.4 0 .4 F 08/27/2001 The day after vaccination the patient was irritable with myoclonic jerks. The patient was treated with Tylenol and Phenobarbitol. Y Y 08/21/2001 08/22/2001 1 PUB PUB NONE 200129 1
0176593 10/23/2001 IN 0.5 0 .5 F 10/16/2001 The patient was seen in the Urgent Care Dept for a rash at the injection site. The patient still had the rash 4 months after the injection, but much less severe. No treatment was received. Y 10/02/2001 10/04/2001 2 NONE PVT PVT NONE Cold, Runny Nose NONE Rash at Injection Site~Polio Virus, Inact. (no brand name)~2~0.00~In Patient 1
0176594 10/23/2001 NC 0.5 0 .5 F 10/08/2001 The patient had a possible seizure. The patient's mother states the child is unresponsive with cool clammy skin. Y Y 10/04/2001 10/06/2001 2 CBC, Chemstrip PVT PUB NONE NONE NONE 1
0176595 10/23/2001 MA 0.1 0 .2 F 10/18/2001 Post vax the patient was unconsolable, screaming for 2-2 1/2 hours then arching, unresponsive, staring for 20 minutes than asleep for 6 hours. Then back to her previous good state of health. Y Y 08/24/2001 08/24/2001 0 NONE PVT PUB NONE NONE Colic, Formula Intolerance 1
0176596 10/23/2001 KY 0.3 0 .3 M 10/10/2001 Post vax, the patient developed a hive type rash, mainly on his arms and a little on his legs. The patient was treated with Benadryl. Y Y 09/17/2001 09/17/2001 0 Urticaria OTH PVT 1
0176597 10/23/2001 NE 30.0 30 F 10/18/2001 Pt developed pain, redness and heat that measured 4 1/2" by 3 1/2", at the injection site. Pt was given Diprolene cream to help with itching. Y 10/15/2001 10/15/2001 0 PVT PVT 1
0176598 10/23/2001 PA 48.0 48 M Employee called on 10/15/01 to report that at 23:00 that evening, post vax, he developed a headache, lower back and knee "joint" pain. The following day, pot vax, on 10/10/01, he had a low-grade fever of 100F, muscle aches, felt very fatigued and experienced diarrhea. On 10/11/01, muscle aches improved, no diarrhea but had malaise. He took 1000mg Tylenol. On 10/12/01, myalgia was gone, had no diarrhea, no fever but felt tired. On 10/13/01, he felt fine. Y 10/09/2001 10/09/2001 0 NONE PUB OTH Niospan; ASA 1 po daily NONE Allergy to dust; (currently on Niospan and ASA for increased triglycerides) Similar symptoms last year~Influenza (Seasonal) (Fluzone)~~47.00~In Patient 1
0176599 10/23/2001 PA 42.0 42 F 10/15/2001 Reported to Employee Health office at 12:45, indicating that she did not "feel well" since receiving the flu shot this morning. Complained of onset of "headache" and pain in the right side of her neck radiating down her back. She rated pain as a "5" on pain scale of 0-10. BP-120/72; P-70; R-16; temperature 98.2F. Injection given in left deltoid. There was no redness, swelling or warmth although she reports it does feel "sore". Physician notified and she was given Motrin 400mg po at 12:55. On 10/18/01, no further complaints, it was resolved. Y Y 10/15/2001 10/15/2001 0 NONE PUB PVT NONE 1
0176600 10/23/2001 IN 75.0 75 F 10/15/2001 Swollen upper lip, edema and redness at injection site. 6X10 cus. A follow up report received 11/01/2001 adds: Reporter gave additional time line info; pt seen at local ER on 10/14/01 where she was given Decadron and Depomedrol; she was checked in the office on the 15th with some improvement. Office personnel saw her in passing today and she looks well. Y 10/12/2001 10/13/2001 1 PVT PVT Premarin, calcium, Lipitor, Prilosec NONE Tetracycline allergy - stomach cramps with notencum. 1
0176601 10/23/2001 MA 70.0 70 F 10/18/2001 Local redness and edema at site of injection. A follow up report received 10/25/2001 adds: Reporter states Pt was treated with Augmentin and problem cleared within a few days. Y 10/16/2001 10/17/2001 1 PVT PVT Lipitor, Tagamet, Atenolol NONE KNDA 1
0176602 10/23/2001 MS 75.0 75 M 10/16/2001 Left arm with raised area at ? site injection below bruised in about a 12 inch area running down arm also yellowish area. Y U 10/10/2001 10/12/2001 2 PUB PUB Baby ASA and Altrace NONE NKDA-HTN Bypass surgery 1
0176603 10/23/2001 IL 63.0 63 F 10/16/2001 Symptoms started 13:30 PM, unable to raise right arm. Swollen right arm. Aching on back on right arm. When arrived home after work applied ice. Then went to heat during night. Unable to sleep, taking Advil, rated pain as 9 on scale 1 to 10. Advil doesn't relieve pain. Advised to check with her doctor. 10/17/01, spoke with pt, she did not go to doctor. Pain decreased with ice, heat, Aleve, back at work. A follow up report received 10/25/2001 adds: Pt was very clear she had much improved overnight when reporter had called day after injection given. Y 10/15/2001 10/15/2001 0 PUB PVT NONE 1
0176604 10/23/2001 PA 46.0 46 F 10/15/2001 Reported onset of headache about 10-15 minutes after injection given. Also complained of arm "aching" and pain down right arm. Rated pain as a "5" on pain scale of 0 to 10. Took 2 Motrin around 9 am which has helped the headache and sore arm. Right deltoid area with swelling, redness and warmth. Physician follow up call "no headache, arm just sore", but better. Y 10/15/2001 10/15/2001 0 BP 122/68-80-16 temperature 98.2 PUB PVT Claritin, Pulmacort and Albuterol. NONE Environmental Allergies 1
0176605 10/23/2001 CO 10.0 10 F 10/03/2001 Post vax, the patient developed pain, itching, swelling and heat at the injection site. The patient had vesicles, numerous clumps, at the injection site. The patient had a fever off and on and complained of over all body aches and pains and nausea. Y 09/21/2001 10/01/2001 10 NONE PUB PUB NONE NONE Penicillin allergy CO01020 1
0176606 10/23/2001 MA 4.0 4 M 10/17/2001 Post vax, the patient developed swelling and erythema of the left deltoid region approximately 3"x3" in size. Y 10/12/2001 10/14/2001 2 PVT PUB NONE NONE 1
0176608 10/23/2001 MN 62.0 62 F 10/16/2001 Post vax, on 10/09/2001 the patient broke out with 50 pox. By 10/15/2001 she had 150 pox. The patient complained of being tired and itchy. No other symptoms. Y Y 10/02/2001 10/09/2001 7 Papule sent to determine strain PUB PVT Prempro, Flovent MDI, Singulair NONE Asthma 1
0176609 10/23/2001 GA 4.0 4 M 10/19/2001 The patient developed swelling to the left upper arm after vaccination. The mother used a cool compress and Tylenol as directed. U 10/16/2001 10/18/2001 2 PUB PUB NONE NONE 1
0176610 10/23/2001 CA 4.0 4 F 10/12/2001 The patient developed erythema and swelling of the left thigh at the injection site beginning 24 hours after administration of vaccines. Y 09/28/2001 09/29/2001 1 NONE PUB PUB NONE NONE 1
0176611 10/23/2001 AR 4.0 4 M 10/05/2001 Post vax the patient developed a very large local reaction with significant upper extremity edema and erythema. The patient was treated with Motrin, Benadryl and Keflex. Y Y 10/02/2001 10/03/2001 1 NONE PUB UNK NONE NONE 1
0176612 10/23/2001 CA 45.0 45 F 10/16/2001 Rash on leg approximately 1/2 hour after receiving TD injection, 08/27/2001. By 09/04/2001, rash had spread to legs, arm, neck and face. Course of Allegra not helpful. Two courses of Prednisone and Atovax controlled symptoms but rash returned on 10/08/2001 after 1 week of stopping meds. N 08/27/2001 08/27/2001 0 NONE PVT PVT Lotensin 10 mg and Ortholycyclone Finger laceration Hypertension 1
0176613 10/23/2001 MO 44.0 43 F 09/27/2001 Right upper arm has red, swollen, hot area 4 inches by 2.5 inches with bruising. Y Y 08/24/2001 08/25/2001 1 NONE PUB PUB Respa DM, Prilosec, Allegra, HCTZ and Amoxicillin Sinusitis with allergic rhinitis GERD and COPD MO2001052 1
0176614 10/23/2001 CO 4.0 4 F 10/11/2001 Vaccine given 09/26/2001. Pt presents 10/11/2001 with 1 day history of localized swelling and erythema to right triceps. Multiple small resicular lesions to arms, buttock, ear, neck from day 13 PV. Triceps very warm, red and pruritic. Y 09/26/2001 10/10/2001 14 NONE PVT PUB NONE NONE Amoxicillin caused rash 1
0176615 10/23/2001 CA 15.0 15 F 09/18/2001 Post vax the patient complained of myalgias, diffuse paresthesis in the lower extremeties, a headache, nausea, weakness in her legs and difficulty ambulating. Lab work was OK. The patient had a marked muscle spasm. Y Y 09/04/2001 09/05/2001 1 CPK and CBC = WNL PVT PVT Orthotricyclen NONE NONE 1
0176616 10/23/2001 KY 10.0 10 F 10/17/2001 Post vax the patient develeoped a macular rash at the injection site, on her upper chest and the top of bilateral arms and shoulders. The patient was treated with Benadryl. Y 10/17/2001 10/17/2001 0 NONE PUB PUB NONE NONE NONE KY2001078 1
0176617 10/23/2001 OH 30.0 30 F 10/19/2001 Post vax, the patient experienced myalgia, fatigue and a decrease in appetite. U 10/02/2001 10/02/2001 0 NONE OTH OTH Thyroxine NONE NONE 1
0176618 10/23/2001 TN 35.0 35 F 10/03/2001 Approximately 2 hours post vax the patient developed a big knot at the injection site. The area was very red and itched. That evening the arm was very swollen to the elbow, red, hot to touch and itched. The patient could not remove her rings and her ankles were also swollen. The patient was treated with Benadryl and cold compresses. Y 10/02/2001 10/02/2001 0 PUB PUB NONE NONE Mitral Valve Prolapse TN01050 1
0176619 10/23/2001 TN 5.0 5 F 10/05/2001 Two weeks post vax, pt experienced fever as high as 103F for three days. Each evening of these 3 days, the pt had 1-2 seizures. Pt's mother describes these seizures as similar in character to previous epileptic seizures the child has experienced. Y 08/09/2001 08/23/2001 14 PUB PUB Seizure medication Epilepsy TN01051 1
0176620 10/23/2001 PA 10.0 10 F 10/15/2001 Pt began having aching joints in fingers. To date, this has progressed to knees, ankles, wrists, and 1 shoulder with some swelling in the joints. She also has fatigue. Pt has been limping for 9 days. Pt's MD does not know enough about her symptoms and referred pt to a rheumatologist. Pt takes ibuprofen daily. Y N 09/18/2001 10/05/2001 17 Elevated sed rate PUB PVT NONE NONE NONE ~Hep B (no brand name)~1~0.08~In Sibling|~Measles + Mumps + Rubella (no brand name)~1~1.50~In Sibling 1
0176621 10/23/2001 SC 37.0 37 F 07/20/2001 Pt complained of "so much drainage" in her throat and chest and had labored breathing. This started the day after immunizations were given and lasted 8 days. She took a decongestant for this. Four days, post vax, she noticed a tiny "knot" under the site of MMR injection and this has been getting bigger each day. It is hot to touch, tender, swollen and red. Y Y 07/09/2001 07/10/2001 1 PUB PUB NONE SC0144 1
0176622 10/23/2001 CA 2.6 2 .6 M 10/05/2001 The pt developed a temperature of 103F and shortness of breath. Y 10/05/2001 10/05/2001 0 PUB PUB Antibiotics Recovering from bronchitis NONE CA010114 1
0176623 10/23/2001 NH U Pt was given a Hep-B and MMR on 8/16/01. On 9/26/01, she developed a unilateral blurry vision and was subsequently dx'd with retrobulbar neuritis. This was transient (about 2 weeks). Y 08/16/2001 09/26/2001 41 MRI-nml PVT PUB NONE 1
0176624 10/23/2001 CA 27.0 27 F 10/01/2001 On 10/1/01, pt had left neck stiffness; soreness at site of injection since 9/2/01 which is better now but still has some pain on left neck and upper shoulder. #2 given today. Pt also had TB skin test ID in the RA, 1 previously. Y 10/01/2001 PUB PVT BC pills NONE NONE 1
0176625 10/23/2001 MI 1.8 1 .7 M 10/18/2001 20 minutes, post vax, the pt had uncontrollable crying. He threw up during this fit. He had a shaking episode for a few minutes where his arms were quivering. Y 10/15/2001 10/16/2001 1 NONE PVT PVT NONE NONE NONE 1
0176626 10/23/2001 MN 5.4 5 M 10/17/2001 Blotchy hives on neck and chest at 15:00. 3 1/2 hours, post vax, mother of child gave Benadryl according to package for child's weight and mom said 1/2 tsp of liquid Benadryl. N 10/17/2001 10/17/2001 0 PUB OTH NONE NONE 1
0176627 10/23/2001 RI 1.0 1 .0 M 10/15/2001 ITP; on Winrho. Y 07/24/2001 08/15/2001 22 Platelets-10,000 PVT PUB NONE Atopic skin rash 1
0176628 10/23/2001 DC 0.08 0 .1 F 10/16/2001 History of a fever of 106.4F, 6 days after vaccine administered. History of thrush and URI. Y Y 10/09/2001 10/15/2001 6 CSF-no growth; UA/UC-neg; HCT-27%; Hgb 9 PVT PUB Tylenol NONE NONE 1
0176629 10/23/2001 TX 5.6 5 M 10/17/2001 On 11/14/00, the pt had a temperature of 101.5F, nausea and vomiting. On 4/23/01, gave pt Pediatric DT in right arm and pt developed a raised whelp with redness. Y 11/14/2000 11/15/2000 1 PVT PVT NONE NONE 1
0176630 10/24/2001 NY 0.2 0 .2 F 10/19/2001 This report is concerning a 9 week old female pt who on 9/19/01 was vaccinated with a dose of haemophilus b conjugate vaccine (+) hepatitis b vaccine recombinant (yeast). Secondary suspect therapy included an IV 160mg per 1 dose of ceftriaxone sodium (Rocephin), a dose of poliovirus vaccine. On 9/19/01, in the morning, post vax, the pt returned home from the pediatrician and vomited. At approx. 16:50, the pt was taken to the ER. She had a fever of 102.6F; pulse was 178 and respirations were 40. It was reported that sepsis was to be ruled out. At approx. 21:00, the pt commenced ceftriaxone sodium (Rocephin) 160mg IV reconstituted with 1 ml of dextrose (D5W) placed into a 500cc bag of dextrose (+) sodium chloride (D5 & 1/3NS) for 1 dose. This was administered through a Soluset. 5 minutes following the administration of Rocephin, the pt turned gray and was relocated to the resuscitation table. The pt went into a generalized tonic seizure and the body stiffened. The pt was treated with O2 (oxygen). The seizure resolved and the pt's color returned to normal. The pt was admitted to the hospital and was changed to another unspecified antibiotic. It was reported that the medical charts stated a working dx of sepsis, seizure and febrile illness. On 9/20/01, the pt remained hospitalized. This was originally reported by a pharmacist. No further information is available. F/U states: Information from a pharmacist indicated that the pt recovered and was discharged from the hospital on 9/26/01. The pharmacist indicated that the pt's serious adverse events were considered life-threatening. Further information has been requested. F/U states: the pt was admitted to the hospital on 9/19/01. Y Y Y 8 Y 09/19/2001 09/19/2001 0 CXR; Channel 7 sequential multiple analyzer ordered; LP contained blood; CBC; temperature measurement-102.6F; total heartbeat count-178; vital sign-40 F/U states: abn lab values include: hemoglobin 5.8; hematocrit 17.6; platelet count 623; glucose 101 OTH OTH Rocephin 160mg; dextrose; dextrose + sodium chloride Tired and fussy the day before. NONE WAES01100763 1
0176631 10/24/2001 FL 2.0 2 .5 M 10/19/2001 Information has been received from a legal firm concerning an 18 month old male who on 10/22/99 was vaccinated with a dose of haemophilus b conjugate vaccine (lot 627558/0725H). The child is alleged to have suffered "devastating injuries through mercury toxicity and associated complications and sequelae and the aggravation of other conditions directly through exposure, via an IM injection of mercury". It was reported that the child has been in the care and custody of his parents since birth. He was born "perfectly normal" and healthy, with an Apgar score "well within the normal range". Developmentally, neurologically and socially, the child was reported to have achieved every developmental milestone anticipated of all normally developing children. These milestones included: by 3 months of age, he was alert, cooing, responding to sounds, responding to others and beginning to recognize and interact with his parents; at 6 months of age, he made speech sounds that form parts of words and was behavior responsive to his environment, his parents, other children and toys; at 18 months of age, he used 3 words strung together in a sentence-type form and had a vocabulary of approx. 25 words. It was reported that at approx. 18 months of age, he was "neurologically devastated by the accumulation of Mercury in his body, having been exposed via IM vaccinations and suddenly regressed developmentally, losing milestones of neurological development previously achieved". It was reported that the pt became withdrawn, unable to speak and unresponsive to his environment. He had a loss of language skills, motor skills and affect. It was also reported that the child received the following vaccinations, along with haemophilus b conjugate vaccine, "that contained the Mercury preservative Thimerosal": on 6/26/97 (lot 441103), 8/26/97 (lot 440-746) and 10/27/97 (lot 440-745), a dose (each date) of Engerix-B; on 8/19/98 (lot 362A2), a dose of Infanrix. The child was vaccinated "in compliance with the then prevailing vaccine schedule". It was alleged that the concomitant and aggregated injections of these vaccines has exposed him to mercury "in excess of all known Federal safe limits" and that the total exposure rate, at the time of report, was 187.5mcg. Upon internal review, mercury toxicity of 187.5mcg, developmental regression/loss of milestones, "unable to speak"/loss of language skills and loss of motor skills were determined to be "Other Important Medical Events". No further information is available. U 10/22/1999 Apgar score on 4/19/97-"well within the normal range" OTH OTH UNK UNK WAES01100787 1
0176633 10/24/2001 IL 0.4 0 .4 F 10/19/2001 Information has been received from a consumer concerning her approx. 22 week old daughter who on 6/6/00, 8/28/00 and 8/30/01 was vaccinated with the 1st, 2nd and 3rd doses of haemophilus b conjugate vaccine, hepatitis b vaccine recombinant (yeast), respectively. Concomitant therapy included 1 dose of MMRII, 1 dose of diphtheria toxoid/pertussis vaccine/teta and 1 dose of poliovirus vaccine. Following the 2nd dose, the pt developed an abscess and "later on" some breathing problems. She "later" developed an abscess on her leg. Following the 3rd dose, she developed another abscess. It was reported that all of the abscesses were lanced and she was on antibiotics "for a long time". It was also reported that her lungs were normal. The pt sought unspecified medical attention. Upon internal review, abscess and "breathing problems" were determined to be "Other Important Medical Events". Additional information has been requested. A 15-day follow up report received 11/16/2001 adds: Follow-up info was received from a nurse on 10/24/2001. She indicated that it seemed the child's mother had taken her for many tests. It was reported that the child was seen most recently in the physician's office on 10/11/2001, with a right buttock abscess. Follow-up info was received on 10/26/2001 from a physician which indicated that the pt had a history of recurrent bronchiolitis, which was why "breathing problems" and a lung biopsy were mentioned in a previous report. It was reported that these issues occurred prior to vaccination with haemophilus b conjugate vaccine (+) hepatitis b vaccine recombinant (yeast). It was also noted that due to the pt's history of bronchiolitis, the pt pt had an immunologic workup, which was negative. It was reported that after each vaccination with haemophilus b conjugate vaccine(+) hepatitis b vaccine recombinant (yeast), the pt developed an abscess in her thigh at the injection site. The physician reported that the pt's last dose of haemophilus b conjugate vaccine (+) hepatitis b vaccine recombinant (yeast) was administered in the right thigh (also reported as the left buttock) in August 2001. Approximately 20 days post vaccination, the pt developed an abscess in her right thigh, which was lanced and she was treated with unspecified antibiotics. It was noted that the pt was currently doing "well". Upon internal review, abscess was determined to be an other important medical event. Additional info has been requested. Y U 08/28/2000 Computed Axial and pulmonary biopsy-"lungs were normal"; "immunologic work-up" negative. OTH OTH Bronchiolitis; dyspnea; pulmonary biopsy WAES01101807 1
0176636 10/24/2001 FL 0.5 0 .5 M 10/22/2001 The child received his 1st injection of Engerix-B (lot ENG22439) on 5/29/97, at 1 month of age and his 2nd injection of Engerix-B (lot ENG229729) on 10/27/97, at 6 months of age. Other vaccines reportedly administered included combination diphtheria and tetanus toxoids and pertussis vaccine adsorbed and haemophilus influenza type b conjugate vaccine (Tetramune) on 6.26/97 and 10/27/97, diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix, lot 362AZ, see report 2001025030-2) on 8/19/98 and haemophilus influenza type b conjugate vaccine (MSD) on 10/22/99. The child's lawyer stated, "The concomitant and aggregated injections of vaccines has exposed him to mercury in excess of all known Federal safe limits. The total exposure to date, exceeds 187.5mcg." The child's attorney alleged that "At approx. 18 months of age, (the child) was neurologically devastated by the accumulation of Mercury in his body, having been exposed via IM vaccinations and suddenly regressed developmentally, losing milestones of neurological development previously achieved, specifically including, but not limited to, the following: a. He became withdrawn, unable to speak, unresponsive to his environment; and b. His injuries include the loss of language skills, motor skills and affect." The attorney alleged that the child "sustained severe devastating permanent neurological injuries." The lot numbers provided for Engerix-B and Infanrix are not valid lot numbers. Y 10/27/1997 OTH OTH 20010250301 1
0176638 10/24/2001 WA 0.2 0 .2 F 10/11/2001 Approx. 5 minutes, post vax, infant started irregular "gasping" respirations. O2 sats decreased to low 80's for 1 minute then recovered to 96-99. Breathing slowly reoccurred to normal over 15-20 minutes. Admitted for observation to hospital. No rashes or fevers. Lungs clear. Y Y 10/11/2001 10/11/2001 0 O2 sats in low 80's PVT PVT NONE NONE NONE 1
0176639 10/24/2001 OH 5.0 1 .0 M 10/16/2001 Pt developed a temperature of 105F with Morbilliform rash, 8 to 9 days, post vax. He has Autism. Y N 04/01/1997 04/10/1997 9 PVT OTH NONE Diaper rash Premature infant born at 33 weeks 1
0176640 10/24/2001 TX 2.0 2 .1 M 10/19/2001 30 hours, post vax, pt's right thigh had redness, swelling and warmth. The whole thigh was red and swollen; redness down past knee. His fever was 106.6 (oral). Y Y 3 Y 10/11/2001 10/12/2001 1 CT Scan of upper leg-neg for abscess PVT PVT NONE NONE Milk allergy 1
0176642 10/24/2001 PA 0.8 0 .9 F 10/18/2001 The pt developed generalized urticaria, including significant erythema and induration to the right thigh. This was second injection of all 5 vaccines. The pt felt most likely due to Prevnar, no respiratory distress. the pt was treated with Benadryl. Y Y 10/10/2001 10/14/2001 4 PVT PUB NONE NONE 1
0176643 10/24/2001 AL 0.3 0 .4 M 10/17/2001 The pt experienced a 2 cm tender nodule at the injection site approximately 24 hours post vax with increased irritability, no fever, no itching, was noted. The pt also experienced erythema to the right upper leg. Treated with cephalexin. Y U 10/15/2001 10/16/2001 1 PVT PUB NONE NONE NONE 1
0176644 10/24/2001 WV 0.2 0 .2 M 10/18/2001 The pt experienced inconsolable crying in the early morning of 10/4/01. Y Y 10/02/2001 10/04/2001 2 Hgb, platelet, blood culture, WBC -10.1 PVT PVT NONE NONE NONE 1
0176645 10/24/2001 CA 7.0 7 F 10/17/2001 The pt experienced a local reaction to the right deltoid with redness / erythema and warmth. Treated with Benadryl and ice pack. N 10/17/2001 10/18/2001 1 PVT OTH 1
0176646 10/24/2001 MD 1.0 1 .0 M 10/18/2001 The pt experienced a fever of 104 and a seizure. Y Y 10/09/2001 10/17/2001 8 PVT PVT NONE NONE 1
0176647 10/24/2001 TX 0.75 0 .8 M 10/16/2001 Pt was seen for well child exam 09/28/2001 at 10:30 am. Mother f/u with me on 10/01/2001 and related that Gustano developed that same afternoon about 4 pm, respiratory distress, angioedema, of the lips and face and an urticaual skin rxn. Pt was treated and released from the hospital, for an anaphylactic reaction to unknown trigger. Continue oral course of Benadryl and Epi-Pen JR. ER states non reactive to vaccine. Has an upcoming appointment with Allergist 10/24/2001 for further testing to determine hypersensitivity trigger. Y Y 09/28/2001 09/28/2001 0 PUB PVT Tacrolimus Clonidine, Prednisone, Ranitidine, Mycophenolate, Acyclovir, Albuterol MNI, Sere Vent mot. Resolving Bronchiolitis previously seen 09/24/2001. History of liver failure to presumed metabolic disorder s/p liver transplant; RAD 1
0176648 10/24/2001 FL 0.39 0 .4 F 10/15/2001 Within seconds of last shot. Legs become red. Red splotches noted over both lower extremities, is seen by Dr. Four dime size spot on forehead. One dime size spot on mid chest. After eight minutes, rash was almost completely resolved. Y 10/12/2001 10/12/2001 0 PUB UNK NONE NONE 1
0176649 10/24/2001 OH 1.0 1 .0 F 10/16/2001 Chick pox rash 2 weeks following Varivax. Y Y 10/02/2001 10/15/2001 13 PVT PVT NONE NONE 1
0176650 10/24/2001 PA 2.0 2 .0 M 10/17/2001 Severe local reaction on 10 cm Drdenta. Y Y 10/03/2001 10/05/2001 2 PVT PVT NONE 1
0176651 10/24/2001 MN 74.0 73 M 10/18/2001 On 10/12 at 9 pm, presented to IC nurse who gave immunization. Rash over entire body, sent to Clinic, was put on Benadryl. States woke up with rash in morning, also had pied for sipper the night before? of reaction from olsu. Rash gone in a few days. Y Y 10/11/2001 10/12/2001 1 PUB PVT BP Medicine, cholesterol medicine, insulin and arthritis medicine. NONE Diabetes, high blood pressure and high cholesterol. 1
0176652 10/24/2001 FL 37.0 33 M 10/17/2001 Day after receiving vaccine, lip was swollen- 2 days later had hives on legs, 4 days later hives on arm, upper back with itching. N 10/05/2001 10/06/2001 1 NONE PVT PVT NONE NONE NONE 1
0176653 10/24/2001 MA 70.0 70 F 10/19/2001 Received call on 10/18/2001 regarding a reaction at site. The injection was given 10/16/2001, client complained of warmth at site, redness and tenderness as well as a bump. Area of redness is about the size of a half dollar. Called 10/19/2001 following heat, swelling is down, redness abating and less tender. Y 10/16/2001 10/17/2001 1 PUB PUB Phenobarbital, Aldactazide and Prevachol. NONE High blood pressure, high cholesterol and seizures. ~Pneumo (no brand name)~1~60.00~In Sibling 1
0176654 10/24/2001 NH 55 F 10/17/2001 Onset of diarrhea after injection. (with 24 hr) Still having same discomfort so question if really related Y 10/05/2001 10/06/2001 1 NONE OTH OTH Zoloft, Tapamax for magraines. NONE NONE 1
0176655 10/24/2001 MI 50 F 10/18/2001 Both arms, above elbows red, swollen, joints ache, red streak inside right arm by elbow. Upper arms warm to touch. Y 10/15/2001 10/16/2001 1 PVT PVT Norvase, Claritin, Flovent, Aleese, vitamins, Keflex Lt otalgia? Dental abscess Penicillin 1
0176656 10/24/2001 CA 50.0 50 F 10/16/2001 After receiving flu vaccine, pt felt deep ache and weakness down left arm. Injection given October 11, 2001 in left deltoid. Pt taking large amounts of Tylenol. 10/12/2001 10/13/2001 1 MIL UNK Synthroid, Prozac and Wellbutrin. NONE PCN, sulfa, depression and hypothyroid. 1
0176657 10/24/2001 OH 68.0 68 M 10/17/2001 Pneumococcal vaccine RD-SQ 10/15/2001. Complained of Redness at site. High fever 103 degrees. Tx Tylenol, cool compress. Referred to family practice. Y 10/15/2001 10/17/2001 2 OTH PVT NONE NONE NONE 1
0176658 10/24/2001 MA 80.0 80 F 10/18/2001 Small bump at injection site right arm at time of injection of flu vaccine (IM). Y 10/18/2001 10/18/2001 0 OTH PUB 1
0176659 10/24/2001 TX 54.0 54 F 10/15/2001 After receiving flu shot, went home and went to sleep. Approximately seven hours later, awoke with rash around waist that progressed to hives all over body and swollen eyelids. No shortness of breath. Missed two days of work. Saw private MD and put on Atarax and Benadryl. Y Y 10/12/2001 10/12/2001 0 NONE PVT PUB Benadryl, Septra, Flonase prn and also on Solu-Medtrol dosepak. Bladder infection Allergic to Acromycin 30 years ago, hives, SOB. 1
0176660 10/24/2001 OH 53.0 53 F 10/17/2001 Three quarters to one inch diameter lump at injection site. Raised and hot to touch with erythma. Benedryl 25mg po given. Ice applied to affected area for 15 minutes. N 10/16/2001 10/16/2001 0 OTH PVT Cafeort, Prometium, Premarin and Prinivil. NONE Diabetes, new onset (early 2001) 1
0176661 10/24/2001 VA 34.0 34 F Low grade fever, very achy. Left arm at injection site red and swollen approximately 2 inches by 2 inches. 11/20/1997 11/21/1997 1 NONE UNK UNK 1
0176662 10/24/2001 U Bradycardia, drug induced hypotension, weakness and respiratory depression. U UNK UNK 1
0176663 10/24/2001 NJ 15.0 M 10/22/2001 15 year old with knee pain, received Lyme disease vaccine recombinant OSpA (LYMErix). Knee pain on and off since 08/24/2001, the medical history, concurrent illnesses, and concurrent medications were not specified. N 10/01/1999 OTH OTH Medical history, concurrent illnesses, and concurrent medications were not specified. 20010209271 1
0176664 10/24/2001 MO 5.0 4 M 10/22/2001 Redenned area to left arm. Prescribed Atarax. Y U 10/11/2001 10/13/2001 2 PVT PVT NONE Injury to back of right ear. NONE 1
0176665 10/24/2001 CO 0.4 0 .4 M 10/18/2001 Redness and swelling over area of shot and 10 days later has 1 cm knot. Y 10/11/2001 10/11/2001 0 PVT PVT 1
0176666 10/24/2001 MO 1.0 1 .3 M 10/17/2001 Leg pain, evening after vaccination given, a limp secondary to hip inflammation and decrease ROM. Not yet recovered, will be following. Y N 10/12/2001 10/12/2001 0 Sed rate-18 (elevated); CRP-1.59; WBC-17.6 PVT PVT NONE Duane's Syndrome (eye abnormality). 1
0176667 10/24/2001 CT 5.0 5 F 10/18/2001 Less than 24 hours later, pt developed pro doable seizure with eye deviation and unresponsiveness greater than. Y Y 10/15/2001 10/16/2001 1 PVT PVT 1
0176668 10/24/2001 FL 66.0 66 F 10/18/2001 Patient recieved vaccination at 1300 hours, at 1900 hours had edema and erythema in area, took 50 mg Benadryl, at 1300 hours pt awoke with worsening edema and erythema up neck and down arm. Y Y 10/16/2001 10/16/2001 0 MIL UNK Zocor, Synthroid NONE Allergic to Sulfa 1
0176669 10/24/2001 SC 48.0 48 M 10/17/2001 Swelling at injection site, heat, tenderness, with low temperature, draining into lower arm (cellutitis), pt PMD, prescribed antibiotics and Benadryl site. Also blurring vision. Y Y 10/11/2001 10/12/2001 1 OTH UNK NONE Allergic Sulfa 1
0176670 10/24/2001 PA 7.0 1 .8 M 10/18/2001 Came to my office with vesicles and differing stages of lesions. Y Y 12/29/1995 10/06/2001 2108 NONE PVT PUB NONE NONE Recurrent Acute 1
0176671 10/24/2001 MA 1.0 1 .0 F 10/18/2001 On 10/5/2001, varicella vaccine. On 10/7/2001, exposed to active varicella. On 10/11/2001, varicella eruption. Y 10/05/2001 10/11/2001 6 PVT PUB NONE 1
0176672 10/24/2001 VA 1.0 1 .3 M 10/17/2001 Parents brought child back into office within a half hour of immunization. Child had huge (6 cm in duration) on leg of HIB vaccine. Benadryl 12.5 po, ice pack, and Tylenol. Gave Benadryl through the night. Y 07/12/2001 07/12/2001 0 PVT UNK NONE NONE 1
0176673 10/24/2001 NC 68.0 67 M 10/18/2001 On 5/19/2001 began having fatigue and backache. On 5/23/2001 developed fever to 100.1 and dark urine. Symptoms resolved 24 hours after fever began. Peak bilirubin 3.4. Exam notable only for mild jaundice. Seen in office 5/24/2001 and asymptomatic. no alcohol. Y Y 05/17/2001 05/23/2001 6 Bili 3.4 AST 416 on 5/23 68 on 5/25. ALT 555 on 5/23 and 272 on 5/25. Positive bitirubin in urine. Hep a ISMC negative, Hep B SAC negative, Core AB negative. LFT's nl 7/31. PVT UNK Diet controlled type 2 Diabetcornellitns; GERD 1
0176674 10/24/2001 TX 70.0 F 10/17/2001 Redness, edema at injection site. Redness extended down arm where injection was given. Also had headache and nausea. Y 08/15/2001 08/17/2001 2 NONE PVT OTH PCN, tetnus vaccine 1
0176675 10/24/2001 TX 74.0 F 10/17/2001 Edema and itching at site of injection, one day after administration. Ordered to take OTC Benadryl and APAP for discomfort and RTC for f/u with MD but pt never showed for f/u appointment. Y 08/13/2001 08/14/2001 1 NONE PVT OTH UNK Cephalosporins and hydoxyzine 1
0176676 10/24/2001 NJ 27.0 27 F 10/09/2001 Pt received Varivax between 8:30am-4:30pm on 6/22/2001. Pt stated on 6/25 that she developed a red circle on arm on 6/22 pm and then soreness and pruritus 6/23 am. Pt took Allegra and then 6/24 Advil and Allegra. On 6/25 visit temp 97.3 BP 100/60 HR 67. Left outer upper arm with 9cm by 9cm are of erythema. Sent to hospital urgent care. Treatment:Reflex 500mg TID. Follow up on 6/29 stated pt felt better. Y Y 06/22/2001 06/22/2001 0 PVT PVT Allegra, Singulair, Rhinbort Aqua and Diluent (MSD) NONE History of Asthma 1
0176677 10/24/2001 NY 24.0 24 F 10/18/2001 No adverse event. Pt called 7/24/2000 stating she was pregnant. Pt had a baby 4/01 with no defects. Y 07/11/2000 Urine Pregnancy Test Negative on 7/11/01. PVT OTH Gestational hypertension in 1995; Migraines 1
0176678 10/24/2001 TX 73.0 F 10/17/2001 Pneumovax given 8/23/2001. Complained of swelling, itching, painful left arm on 8/24/2001, 10 by 10cm erythematous raised area, warm tender. Diagnosis possible early celluitis. Given ice packs, QiD for 24 hours then warm compress, hydroxyzine 25mg TiD, TMC cream, Keflex 500mgTID for 7 days. Y 08/23/2001 08/24/2001 1 NONE PVT OTH UNK UNK NKDA 1
0176679 10/24/2001 IA 51.0 51 M 12/17/2001 Swelling, erythema, redness, pruritis at local area of injection. SOB (Left upper arm) Y 10/11/2001 10/11/2001 0 NONE PVT OTH NONE PCN Allergy 1
0176680 10/24/2001 NM 2.0 1 .0 F 10/16/2001 Herpes Zoster T2 distribution - raised, painful, pruritic, confluent erythema, vesicles on right arm, right chest and right back along T2 distribution for 4 days. Y U 06/19/2000 10/13/2001 481 PUB PUB Tylenol OMI 1
0176681 10/24/2001 MN 9.0 3 F 10/17/2001 Pt developed varicella like lesions after having received vaccine 5 years before. She had temp of 103 at time. There was itching but no crusts. Y 09/26/1995 10/15/2001 2211 NONE PVT OTH NONE NONE NONE 1
0176682 10/24/2001 TX 6.0 6 F 10/16/2001 Hives within 24 hours of second Hep A vaccine. Y 10/15/2001 10/16/2001 1 NONE PVT PVT PPD NONE NONE 1
0176683 10/24/2001 FL 3.0 1 .1 M 10/18/2001 Broke out with chicken pox Y Y 08/06/1999 10/15/2001 801 PVT PVT NONE 1
0176684 10/24/2001 OH 1.75 1 .8 F After immunizations 10/04/2001, she began to throw her leg out when she walked, no knots no limp. U 10/04/2001 10/05/2001 1 PVT PVT 1
0176685 10/24/2001 UT 1.0 1 .0 M 10/18/2001 Red spots on his nose, a runny nose and cough reported by mom, starting a few days after shot, resolved spontaneously. Y 09/12/2001 NONE PVT PVT NONE NONE Mild eczema 1
0176686 10/24/2001 TX 59.0 F 10/17/2001 Edema, redness, swelling of arm, developing to cellulitis. Treated with cephalosporin antibiotic. Y 08/20/2001 PVT OTH Prednisone 1
0176687 10/24/2001 CA 4.0 4 F 09/17/2001 Urticaria, treatment Benadryl. Y N 09/13/2001 09/15/2001 2 NONE PVT PVT NONE NONE 1
0176688 10/24/2001 OH 1.0 0 1 F 10/17/2001 Bumpy rash on face, chest and back area. At site of immunization is red-size of dime-looks black and blue around area. Benadryl and warm compresses. Y 09/05/2001 09/07/2001 2 PVT PVT Amoxil Otitis Media NONE 1
0176689 10/24/2001 TX 30.0 30 M 10/18/2001 Elevated temp (101 oral), muscle aches, headaches and lightheadedness. Y Y 10/16/2001 10/18/2001 2 CBC, UA, C and S Urine UNK PVT NONE NONE NONE 1
0176690 10/24/2001 TX 4.9 4 M 10/11/2001 Day after immunizations, at site of injections have red, subsequently warm area. left thigh measures 5cm by 5cm. Prescribed Augmentin Y Y 10/09/2001 10/10/2001 1 PVT PVT Pulmicort resppules and albutoral. Rash NONE 1
0176691 10/24/2001 MI 4.0 4 F 10/17/2001 Administered DTAP, IPV and MMR given. Noticed while placing Bandaids on that left arm at site of MMR reddened. Pt complained of nothing being wrong except arms sore from injections. Also noticed few red areas on other arm and chest. Notified MD immediately. Benadryl 15mg given and Prelone ttsp po as ordered by MD. 10/17/2001 10/17/2001 0 PVT PVT NONE NONE 1
0176692 10/24/2001 VT 85.0 85 M 10/18/2001 Within 2 weeks of vaccination, pt developed muscle pain, swelling and stiffness. N 08/16/2001 08/23/2001 7 Rh Factor L20, ANA 1:160 Homogeneous, ESR 87. OTH PUB NONE Swelling and painful muscles Atrial Fibrillation in past 1
0176693 10/24/2001 TX 69.0 F 10/17/2001 Edema, erythema, induration and warmth in left arm lateral to medial bicep 8 in by 3.5 in an urticaria. Symptoms began evening on same day of injection. Treated with hydroxyzine 10mg 1-2 98h prn, TMC cream, ice packs then warm compresses prn. Y 08/23/2001 08/23/2001 0 NONE PVT OTH Sulfa, nitrofurantoin and medomen. 1
0176694 10/24/2001 KS 0.4 0 .4 M 10/16/2001 Tremors within 8 hors of shots. Tremors have continued daily since shots. Y U 08/14/2001 08/14/2001 0 PVT OTH Phenobarbital NONE Seizures from first shots. 1
0176695 10/24/2001 NJ 1.0 1 .0 M 10/17/2001 Developed atypical varicella. Y 02/26/1999 10/15/2001 962 PVT PVT sleepy~Diphtheria Toxoids (no brand name)~1~0.00~In Patient 1
0176696 10/24/2001 NC 7.0 7 M 10/17/2001 On 10/15/2001, pt received MMR vaccine at 12 noon. Mother stated seizures started at approximately 8 pm and continued through the night. There were 5 seizures;each lasted 5-10 minutes long; pt arched back, eyes rolled back into head, spitting, shaking and sweating. Y 10/15/2001 10/15/2001 0 PVT PUB Cold Cerebral Palsy seizures~Diphtheria Toxoids (no brand name)~1~0.00~In Patient 1
0176697 10/24/2001 NM 1.0 M Five days after vaccine had focal seizure with fever. Had completely normal evaluation later that day U 01/10/1997 01/16/1997 6 NONE OTH OTH Amoxicillin started less than 24 prior OM symptoms NONE Shuddering~DTP (no brand name)~~0.00~In Patient 1
0176698 10/24/2001 M 10/09/2001 Aches and pains in an "adult" male of unspecified age who received Lyme disease vaccine recombinant OspA (LYMErix). After receiving dose 3 of LYMErix, "two years ago", experienced flu-like symptoms, loss of appetite, weight loss of 10-12 pounds, and increase in gas. Reportedly, he has not seen a physician concerning these symptoms. As of 07/02/2001, the adverse events were reportedly unresolved. N PUB OTH Allergies, medical history and concomitant medications were not specified. 20010161921 1
0176699 10/24/2001 PA 36.0 34 M 07/11/2001 Described Lyme disease in 36 year old male who reportedly received the complete immunization series of Lyme disease vaccine recombinant OspA (LYMErix). This report was received from the vaccine and has been verified by a physician or other healthcare professional. Medical history, concurrent conditions, and concurrent medications were not provided. The vaccinee work outdoors. The vaccinee stated that he received three injections of LYMErix, with the last dose in 05/2000. After 14 months of completing the LYMErix immunization series, the pt underwent a complete physical. he reported fatigue, headaches, and severe joint pain, especially in his feet and hands. The vaccinee requested to be tested for Lyme disease. He was notified by his physician that an unspecified test for Lyme disease was positive. Y U 05/01/2000 07/01/2001 426 OTH OTH Medical history, concurrent conditions, and concurrent medications were not provided. The vaccinee works outdoors. 20010166281 1
0176700 10/24/2001 CT 48.0 48 F 09/20/2001 The pt received the first and second injections of Lymerix in September and October 1999, respectively. The pt had no adverse experiences following the receipt of these two injections. She received her third injection of Lymerix in November 2000. In November 2000, an unspecified time after receiving the third injection, the pt began to experience fatigue. In November 2000 or December 2000, she began to experience "muscle pain all over". In February 2001, she began to experience bone pain and could not move her right arm or her neck. She was seen by her physician who reportedly prescribed massage therapy; this was not effective. In March or April 2001 the pt began to experience stiffness in her left ankle, left knee and left elbow. She also experienced back pain that radiated to both legs, pain that "would travel from "joint to joint", and night sweats. Her symptoms persisted and she was seen by her physician on 07/03/2001. The pt reported that a diagnosis of Lyme disease was made and three weeks of unspecified antibiotics was prescribed. She reported that her symptoms persisted as of 07/16/2001. Y N 11/01/2000 11/01/2000 0 ESR normal, Rheumatoid factor normal, ANA titer normal, CRP normal, Lyme disease test (NOS) positive PVT PVT Synthroid Hypothyroidism and unspecified seasonal allergies. 20010183871 1
0176701 10/24/2001 MO F 08/02/2001 Report 20010185421 described skin turning red (hands and arms) in a female pt of unspecified age who received Lymerix. In 1999 and 2000 the pt received the first, second and third doses of Lymerix. Subsequent to receiving the third dose, the pt felt that her hands and arms were getting redder. Th pt thought that this adverse event was possibly related to Lymerix. As of July 30,2001, the outcome of the event was unknown. U OTH OTH Allergies, medical history and concomitant medications were not specified. 20010185421 1
0176702 10/24/2001 45.0 F 10/09/2001 Report 20010190851 described arthralgias in a 45 year old female who received Lymerix. On March 13, 2001 the pt received a 0.5 mg IM dose of Lymerix, it was not known whether she received a previous doses of Lymerix. On March 14, 2001 the pt experienced arthralgias and fatigue. Lymerix was discontinued. As of August 7, 2001, the outcome of the adverse event was unknown. The adverse event of 'arthralgias' does not meet ICH serious criteria, but is being submitted as an expedited report by special FDA request per the June 28, 2000 letter. U 03/13/2001 03/14/2001 1 OTH OTH Allergies, medical history and concomitant medications were not specified. 20010190851 1
0176703 10/24/2001 WI 31.0 31 M 10/09/2001 Report 20010192221 described joint achiness in a 32 year old male who received Lymerix. This report was received from the pt's wife and has not been confirmed by a physician or other health professional. In January and February 1999, the pt received his first and second doses of Lymerix without adverse event. In January 2000, the pt received his third dose of Lymerix. Subsequently, he reportedly experienced general stiffness and achiness in the joints. Reportedly the pt's joint complaints have not been evaluated by a physician and he has not received any treatment for the joint complaints. Reportedly as of August 8, 2001, the outcome of the events was unresolved. The adverse events of joint achiness and joint stiffness do not meet ICH serious criteria, but are being submitted as an expedited report by special FDA request per the June 28, 2000 letter. N 01/01/2000 OTH OTH Tylenol and Ibuprofen Allergies not specified. Medical history included thoracic outlet syndrome. 20010192221 1
0176704 10/24/2001 U 08/23/2001 Reportedly, the patient received a 3 shot series of Lymerix in the spring of 1999. On 07/23/2001, reportedly, the patient was stung/bitten by an unidentified insect through the shirt at the right scapula. The patient experienced small, instant swelling and redness after the initial sting. There was no pain after the sting until redness and the affected area increased to about 80-100mm. Reportedly, there never was any sign of a tick despite careful checks. On 07/29/2001, reportedly, a double bull's-eye rash appeared. On 07/30/2001 the patient was diagnosed with Lyme disease, for the third time. Ceftin was prescribed for 21 days. On 07/31/2001 at 02:00 experiencing major discomfort in the precise area of the original attack which subsided by 06:00. The patient has had no recurrence so far and was continuing Ceftin. The patient doubts the diagnosis but not the treatment. As of 08/01/2001, the outcome of the event was resolved. Y 07/30/2001 PUB OTH The patient experienced Lyme disease twice prior to this episode. 20010203401 1
0176705 10/24/2001 PA 25.0 25 F 02/14/2003 A 26 year old female became pregnant approximately 8 months following receipt of Lymerix. The pt reported that she had no significant medical history. Concurrent conditions and medications were not specified. The pt reported that she received to injections of Lymerix in the year 2000, the last injection administered in approximately August 2000. Exact dates of immunization were not provided. She had no adverse experiences following receipt of the two vaccine injections. The pt subsequently learned that she was pregnant. Her last menstrual period began on 25-MAR-2001. Date of positive pregnancy test not reported. Her estimated delivery date is 31-DEC-2001. As of 10/10/01, the pregnancy was progressing normally, without complications. On 12/10/01, the vaccinee delivered a male infant via "normal vaginal delivery." The infant weighed 7 lbs. 3 oz and measured 20 inches in length. On 1/9/02, the obstetrician reported "no problems with mom or baby." Y Y 08/14/2000 03/25/2001 223 OTH OTH UNK 2001020457 1
0176706 10/24/2001 NJ 25.0 F 02/14/2003 On 21-JUN-2001, a 25 year old female, with low blood sugar, receives a Lymerix vaccination while unknowingly pregnant. Pt also received an injection of tetanus toxoid. Concurrent conditions include asthma, unspecified allergies, an irregular menstrual cycle and polycystic ovary syndrome. The pt had no known drug allergies and no known prior pregnancies. It is not known if she had previous Lyme disease. Concurrent medication included Singulair, Vanceril and Proventil. The pt had been prescribed a course of doxycycline for an unknown indication in June 2001. At 6pm on 21-JUN-2001, the pt passed out and was taken to the local ER. A diagnosis of low blood sugar was made and the pt was treated with "some food". An unspecified pregnancy test was positive. It was determined that the pregnancy was at 24 weeks gestation; the pt reported that she did not know she was pregnant earlier in the day, when she was immunized. Her last menstrual period was in December 2000; her estimated delivery date is 06-OCT-2001. The ER physician did "not relate incident (low blood sugar) to vaccines". The pt was released from the ER. Additional information was received from the pt's obstetrician on 28-AUG-2001. The OB first saw the pt on 15-JUL-2001; she reported to him that she did not appreciate that she was pregnant until "a few days" prior. She reported to the OB that her last menstrual period had been in "late November 2000";the pt did not recall her last prior menstrual period. She had received no prior prenatal care and had not taken prenatal vitamins. Estimated date of confinement to be 06-OCT-2001. The follow up states the emergency room physician did "not relate incident (low blood sugar) to vaccines." The vaccinee was released from the ER. Additional info was received from the vaccinee's obstetrician on 8/28/01. The obstetrician first saw the vaccinee on 7/15/01; she reported to him that she did not appreciate that she was pregnant until "a few days" prior. She reported to the obstetrician that her last menstrual period had been in "late November 2000"; the vaccinee did not recall her last prior menstrual period. She had received no prior prenatal cars, and had not taken prenatal vitamin supplements. Estimated date of confimement was confirmed to be 10/6/01. The most recent info was received from the vaccinee on 2/1/02. She reported that she delivered a female infant on 10/6/01. The vaccinee stated, "No complications with preganncy after the day of the injection. Baby was born full term on he rdue date. Baby's health seems to be perfect to date. Mom is also doing fine." Y Y 06/21/2001 06/21/2001 0 Pregnancy test positive PVT PVT Singulair, Vanceril, Doxycycline and Proventil. Concurrent conditions include low blood sugar, asthma, unspecified allergies, an irregular menstrual cycle and polycystic ovary syndrome. 2001020467 1
0176707 10/24/2001 MD 13.0 M 10/09/2001 On 09/05/2001 a 13 year old male received a Lymerix vaccination. In September 2000, the pt reportedly received his first dose of Lymerix without adverse event. On 06-SEP-2001 the pt reportedly experienced a slight fever and 1/2 to 1 inch redness at the injection site. The reporter stated that the vaccine "was not in a clinical trial". As of 06-SEP-2001, the outcome of the adverse events was unknown. U 09/05/2001 09/06/2001 1 OTH OTH Allergic to Penicillin 20010215551 1
0176708 10/24/2001 KY 59.0 59 M 02/14/2003 A 61 year old male received Lymerix. Reportedly, the pt was allergic to penicillin and bees. Also the pt's medical history included cervical and back problems. Reportedly on 28-APR-1999, the pt received his first dose of Lymerix. Reportedly three days later he experienced fatigue. On 28-MAY-1999, the pt received his second dose of Lymerix. Reportedly post vaccination his fatigue continued and he was found to have pernicious anemia. Reportedly, he was treated with Nascobal Nasal gel one squeeze per week and his fatigue and anemia subsequently "resolved". Reportedly, on 28-APR-2000, the pt received his third dose of Lymerix without adverse event. "Follow up labs taken on 23-AUG-2000 were all normal". As of 05-SEP-2001, the adverse event had reportedly resolved. The follow up states on 1/22/02, the responsible physician reported that the vaccinee had experienced tiredness in August 1999 which was moderate in intensity and possibly related to LYMErix. The vaccinee's vitamin B12 level in 1999 was reported aa 168pg/ml. Responsible physician stated that the vaccinee was subsequently found to have pernicious anemia. Y Y 04/28/1999 05/01/1999 3 PUB PVT Lipitor and ibuprofen Allergic to bees and penicillin. Back and cervical problems. Cervical problems. 2001021620 1
0176709 10/24/2001 MA 1.0 1 .0 F 10/15/2001 Received MMR and Varivax 10/02/2001. OM diagnosed 10/5, put on Amox, red spots on 10/12/2001, increased spots over next several days. ER 10/14 to give Benadryl PO. 10/15 rash worse. Extensive moribilliform rash on face, trunk and extremities. Slightly raised erythmacules 3- 6 mm in size. Zero target lesions. U 10/02/2001 10/12/2001 10 NONE PVT PUB Amoxicillin NONE NONE 1
0176710 10/24/2001 KY 59.0 57 F 02/14/2003 Described anemia (NOS) in a 59-year-old female who received Lyme disease vaccine recombinant OspA (LYMErix). This report was received from the vaccinee and has not been verified by a [hysician or other health care professional. Reportedly, the vaccinee was allergic to ampicillin, and dextropropropoxcyphene (Darvocet). Vaccinee had anemia (NOS) at times. The follow up states the vaccinee had lactose intolerance beginning in 1999. The vaccinee reported that she received her first left deltoid dose of LYMErix on 4/28/99. Three days later she felt fatigued. Reportedly, on 5/28/99, the vaccinee received her second left deltoid dose of LYMErix. She reported that, on 6/6/99, she experienced a drop in red blood cell and hematocrit counts. Her fatigue continued. Reportedly, on 8/9/99 and 8/10/99, repeat lab tests showed continued decrease in red blood cells, white blood cells, and hematocrit. The vaccinee stated that a diagnosis of anemia was made "because I had low RBC, WBC, and HCT counts. Her "B12" was normal, reportedly. She stated that she underwent three occult blood tests, esophagogastroduodenoscopy, and colonoscopy. These tests were reportedly normal. Reportedly, on 9/2/99, lab tests were repeated: WBC was normal, and RBC and HCT were "almost normal." Reportedly, on 10/25/99, WBC, RBC and HCT were all "dropping." No treatment was given. Reportedly, 4/13/00, all lab values were normal. On 1/20/02, the reporting physician stated that on 8/10/99, the vaccinee reported fatigue to him. Lab analyses performed in August 1999 showed HCT 30%, WBC 3300/cumm, and platelet count of 141,000/cumm. Reporting physician stated htat the fatigue was moderate in intensity and was possibly related to LYMErix. Reportedly on 4/28/00, the vaccinee received her third left deltoid dose of LYMErix. oN 8/23/00, her WBC was "low," and her RBC and HCT were normal. In February 2001, all labs were reportedly normal. As of 9/5/01, the vaccinee's symptoms had resolved. Y Y 05/28/1999 08/09/1999 73 Examination - Occult Blood, result Text: NORMAL, EGD result Text: NORMAL. Exam Date: 08/1999, Examination, Colonoscopy, Exam Date: 08/1999, Result Text: NORMAL PUB OTH Lamisil (Terbinafine), Vitamin E, Calcium, Folic Acid, Acetylsalicylic Acid, Hormone Replacement (NOS), Sporanox (Itraconazole), Iron. Allergic to Ampicillin, allergic to Darvocet, Intermittent Anemia. Reportedly, the vaccine had anemia (NOS at times. The vaccinee received iron as needed, hormone replacement (NOS), vitamin E, acetylsalicylic acid, calcium, folic acid, terbinafine (Lamisil), and itraconazole (Sporanox). 2001021704 1
0176711 10/24/2001 VA 39.0 F 02/14/2003 There was no significant medical history, known allergy or concomitant medications. The pt received her third injection of Lymerix on approximately 22-JUL-2001. She was seen by an OB on 27-AUG-2001 and determined to be pregnant, at 11 weeks gestation. The pregnancy was, therefore, at 6 weeks gestation at the time of Lymerix administration. The pt's last menstrual period was on 09-JUN-2001. Estimated delivery date is 16-MAR-2002. The follow up states the vaccinee delivered a normal, full-term female on 3/5/02 (39 weeks gestation). Birth weight was 7 pounds 12 ounces. Y U 07/22/2001 08/27/2001 36 OTH OTH There was no significant medical history, known allergy or concomitant medication. 2001021848 1
0176721 10/25/2001 MD 49.0 49 F 10/17/2001 Pt developed a fever of 102F-103F, 24 hours, post vax. The fever lasted 6 days (101F-102F). She had extreme body/muscle aches and was dx'd with pneumonia, 5 days, post vax. Followup states coughing and wheezing, treated with Tilade Y Y Y 10/03/2001 10/04/2001 1 CXR on 10/8/01-positive for RLL Pneumonia OTH PUB NONE NONE NONE 1
0176723 10/25/2001 GA 0.3 0 .4 F 10/23/2001 Pt developed fullness about injection site on right anterior, lateral thigh with minimal redness (? secondary to Prevnar or HIB) per MD's note. Y Y 10/18/2001 10/21/2001 3 PVT OTH NONE NONE NONE 1
0176724 10/25/2001 OR 0.8 0 .9 F 10/05/2001 Within three hours of receiving the vaccine, the patient developed a fever of 103F and hives head-to-toe. The patient was treated with Ibuprofen. Y 10/02/2001 10/02/2001 0 PUB PVT NONE NONE NONE OR200138 1
0176725 10/25/2001 OR 0.6 0 .6 F Post vax, the patient had a "high fever". The patient's mother did not check the patient's temperature. The patient developed a pinpoint rash on her upper arms and chest and red blisters on her buttocks. U 10/01/2001 10/01/2001 0 PUB PUB NONE NONE OR200137 1
0176726 10/25/2001 OR 1.3 1 .4 M 09/28/2001 On 09/22/2001 the patient broke out with approximately 3 large vesicles and complained of pruritus. On 09/24/2001 smaller vesicles appeared on the patient's back, legs, stomach, face and chest. The patient's fever was up to 102.7F. The patient had red, watery eyes with exudation from his eyes. N 10/17/2001 10/17/2001 0 NONE PUB PUB NONE OR200139 1
0176727 10/25/2001 WI 0.3 0 .4 M 10/17/2001 Within 5-6 hrs post vax, pt noted to have redness, warmth and induration around immunization area. Pt also was fussy and whimpered when right thigh moved. He was brought back in to office 6 hrs after immunization for recheck on area. A very faint, circumscribed area around IPOL with faint blue ring with clear center (2" in diameter) noted. He was treated with Benadryl. Site of reaction treated with warm moist compresses. Y 10/15/2001 10/15/2001 0 PVT UNK Zantac, Albuterol NONE Cow's milk protein allergy 1
0176732 10/25/2001 MA 0.2 0 .2 F Based upon report received from caller her 2 month old female baby was inadvertantly administered two doses of Prevnar instead of one dose of Prevnar and one dose of DTaP vaccine. Caller stated the pt was fussy, had increased wet burps and had restless sleep. The Prevnar injections were given on 10/16/2001 and the onset of reactions were on 10/17/2001. Field alert being issued for a medication error that resulted in an adverse event. 10/16/2001 10/17/2001 1 UNK UNK HQ7302018OCT2001 1
0176733 10/25/2001 PA 5.0 F 07/23/2001 A mother reported, via a company representative, that her 4.5 year old daughter received an initial dose of Prevnar vaccine in DEC-2000. In DEC-2000, she developed wheezing and coughing. In JAN-2001, the child developed a "barking" cough that did not resolve for months. The child has also been on antibiotics every month since receiving Prevnar for ear infections. The HCP told the mother that the child's lungs were clear. In APR-2001, the child developed bilateral ear infections, cough and was diagnosed with pneumonia. The child developed a fever of 104 degrees, of 6 days duration. After 2 days of fever, was treated with Zithromax with no resolution of fever. The child developed "violent" vomiting for 3 days and then developed "severe" diarrhea. The fever was treated with Tylenol or Advil and it resolved. No additional information was available as of this report. Follow up information received 7 JUL 2001, stated that child had several ER visits. Additional information received 7 SEP 2001, stated that the child was given a diagnosis of asthma in July 2001. Y U 12/01/2000 04/01/2001 121 UNK PVT OTH UNK UNK UNK ~Pneumo (Prevnar)~1~0.00~In Sibling 3176512 1
0176748 10/25/2001 FL 70.0 70 M 10/18/2001 Swelly, redness and warmth right deltoid. Y 10/10/2001 10/11/2001 1 NONE PVT PVT Prinurl, Adexu, Combiveal, zeutar NONE CAD, COPD, Cellepc rlunetu 1
0176749 10/25/2001 KS 54.0 54 F 10/24/2001 Back pain, swollen right arm, face swollen, right side, neck pain, nausea went to ER - Diagnosed with local reaction Taken within Demerol, amonicillin. For spider bite on foot 10 days old (left foot). Went to ER also on 10/20/2001. Taken with phenerean and Demerol. Y Y 10/19/2001 10/19/2001 0 PVT PVT Asthma curt, xopenex, rhinacort, aqua, lopio, inderol, nexium, HRT, Naprosin, Calcium, Zarter, Knonopin Nephropathy, spider bite, copd, asthma, gerd, hyperchlov 1
0176750 10/25/2001 CA 47.0 47 M 09/27/2001 Fever, chills times 3 days, acetaminophen 500 mg every 8 hours. Y 09/21/2001 09/21/2001 0 PUB PVT NONE NONE 1
0176751 10/25/2001 CA 22.0 22 F 09/27/2001 Fever, chills, nausea, body ache, headache, congestion. Y 09/12/2001 09/21/2001 9 PUB PVT NONE NONE 1
0176752 10/25/2001 CA 38.0 38 F Hives on Saturday. Asthma, SOB, fever and diarrhea. Y Y 09/20/2001 09/21/2001 1 PUB PVT Lotension; Norvasc Lupus Lupus 1
0176753 10/25/2001 CA 36.0 36 F 09/28/2001 Tiredness, sneezing, stuffy nose, cough, sweating, itchy and watery eyes, headache, sensitivity to light, loss of appetite and sore throat for seven days. Y 09/27/2001 09/28/2001 1 PUB PVT NONE NONE 1
0176754 10/25/2001 OR 45.0 45 F 10/22/2001 Approximately three to four hours after administration, pt was sweating, rapid heart rate, rapid, shot breathing, low blood pressure and feeling weak. Y Y 10/19/2001 10/19/2001 0 BP 110/70 HR 115 OTH PVT Fastin, Combivent, Wellbutrin SR, and Vioxx. NONE Asthma 1
0176755 10/25/2001 IA 19.0 19 F 10/14/2001 Warm, red, raised area at injection site, 24cm in diameter, no respiratory distress, note 18.5 hours later. Y 10/13/2001 10/14/2001 1 NONE MIL MIL Orthotrycyclin NONE Penicillin allergy IA01014 1
0176756 10/25/2001 KY 17.0 17 F 10/23/2001 Fine rash around sit ot tight deltoid. Pt reported short loss of breath all day attended school didn't visit school nurse. Called health department at 1500, referred for shortness of breath. Possibly allergic reaction. Treated 10/23/2001 with Decadrom IM and Preventil. Nebulizer treatment. Sent home with Prednisane pack and Proventil Inhaler. Y Y 10/22/2001 10/23/2001 1 NONE PUB PVT NONE Allergic to Motrin, Keflex, Penicillin, Phenrgan and Benedryl. KY2001079 1
0176757 10/25/2001 OR 82.0 82 F 11/21/2000 Spontaneous report received on November 16, 2000, from Medical Assistant in a Dermatologist office, regarding adverse event possibly related to administration of Fluvirin. On October 06, 2000, this 83 year old female received a Fluvirin injection. "Shortly after" receiving the injection, she developed a temperature of 102 degrees, chills and general malaise. These symptoms lasted approximately four days. In mid October, she developed lesions on her hands and in her mouth. She was treated with an unspecified course of Prednisone, with symptom abatement. After completion of the Prednisone therapy, the symptoms reappeared. She was then treated with an injection of Kenalog and topical use of Orobase and Kenalog ointments; lesions remain at the time of this report. The diagnosis of Stevens Johnson Syndrome has been made. The reporter stated that the Dermatologist's office has treated this patient for over ten years. She indicates that the pt is normally very "mentally there" but that the pt "hasn't been herself". She describes pt as being "easily confused and forgetful". Additional information has been requested from the physician. Follow up information from Primary care physician received on October 11, 2001 by Evans Vaccines: "The additional adverse events of sore throat and swollen lip were identified. PT has resolution of symptoms by November 20, 2000. Dosages and therapy dates of concomitant medications were clarified. Y 10/06/2000 PVT OTH Cozaar, Norvasc, Temazepam, Cidihiua, Chlordiazepoxide and Levothroxine, potassium Hypertension, Pharyngitis, Hypothyroidism, G I problems, increased weight loss MPI2000049221 1
0176758 10/25/2001 NY 30.0 30 M 10/23/2001 Pt developed sores in mouth and aching in muscles and joints and was also tired. U 10/19/2001 10/20/2001 1 NONE OTH PVT NONE NONE NONE 1
0176759 10/25/2001 NV 40.0 40 F 10/17/2001 Pt developed extreme fatigue, lower back pain, and abdominal area swelled. Pt complained of severe pain, nausea, chills, and inability to move. Pt went to ER on 9/28/01 at 5 AM and was given pain pills. She was told to go to ER if not better in 2 days. She was given a referral to a specialist. Y U 09/25/2001 09/26/2001 1 PUB PVT NONE NONE Hepatitis B disease, Hepatitis A disease 1
0176760 10/25/2001 IN 7.0 1 .5 F 10/18/2001 Pt broke out in chicken pox and fever. Y Y 07/10/1995 10/11/2001 2285 NONE PVT PVT NONE NONE NONE 1
0176761 10/25/2001 WA 1.5 1 .5 F 10/13/2001 On 10/5, pt developed a fever to 103. Pt developed a maculopapular rash on face and trunk onset 10/8/01. Y 09/26/2001 10/05/2001 9 NONE PVT PUB NONE NONE 1
0176762 10/25/2001 WA 36.0 36 F Pt developed acute pain, redness and induration of entire lateral shoulder with urticaria locally. Pt also had chills, diaphoresis, and low grade fever resolving after 2nd day. Y 10/16/2001 10/17/2001 1 PVT PUB Allegra, Wellbutrin, Ortho-Tri-Cyclen NONE Paroxysmal atrial tachycardia, migraine 1
0176763 10/25/2001 OR 4.6 4 M 09/17/2001 Pt developed fever of 105 with seizures one week post vax. Pt also developed "blotchy, irritated" area on back and legs. Pt was seen in ER. Y Y 09/06/2000 09/13/2000 7 NONE PUB PUB NONE NONE Liver laceration, pelvic and head injuries @ 10 mos due to MVA OR200140 1
0176764 10/25/2001 VA 0.75 0 .8 M 10/18/2001 Onset of fever 1 hour after hepatitis B vaccination, intermittent with high of 102 degrees for 48 hours. Now with urticaria on 10/17/01 visit. Y 10/15/2001 10/15/2001 0 PVT UNK NONE Eczema NONE 1
0176765 10/25/2001 MI 1.0 1 .3 M 10/19/2001 Cough, erythematous, macular-papular rash, extensive, non prurtic. U 10/08/2001 10/18/2001 10 NONE PVT PVT NONE NONE NONE 1
0176766 10/26/2001 MD 52.0 48 M 10/09/2001 The pt experienced swollen feet, hands, fatigue, aches, headache, fever, joint pain, memory loss. The pt states he has been sick since 8/98. Treated with Doxycillian, Vioxx, and Tylenol. Follow up information received 04/25/2003 states: Eyesight failing, hearing loss, memory loss increased, low grade fever daily, face numbness, rash, arthritis progressed, blank staring daily. Depression. Short patience. Constant head sweats. Y N 04/27/1998 08/01/1998 96 Western Blot, blood work PVT PVT NONE NONE 1
0176768 10/26/2001 CA 52.0 52 M 10/25/2001 Fot Flu shot 10/16/2001. On 10/21/2001 had coughing, hot feeling, sweating, flem in throat, light headedness and weakness. Has lasted four days so far. Not real sick, just slightly. Y N 10/16/2001 10/21/2001 5 PUB OTH Respidal, Flucaplage, etc. NONE Diabetes, High Blood Pressure and bad nerves. 1
0176769 10/26/2001 OK 46.0 46 F 10/25/2001 Pt had very sore left pectoral muscle, up into left armpit. Had fever at the site of the injection, mild nausea and pulsating pain in left pectoris, onset the day after injection. Y 10/23/2001 10/24/2001 1 NONE PVT PVT NONE NONE 1
0176770 10/26/2001 MN 20.0 20 M 10/22/2001 Pt c/o LD pain started on 9/18/01 after vaccine. Pt has had temperature, soreness and swelling to LD since 9/18/01 and has been taking Tylenol but ineffective. this sx continue from 9/18/01 to now. Y N 09/18/2001 09/18/2001 0 PUB OTH NONE NONE 1
0176771 10/26/2001 CO 39.0 39 F 10/08/2001 Received TD booster on 11/5/01. Right deltoid developed arm pain and stiffness and stiffness into her neck and shoulder. 10/05/2001 10/05/2001 0 CBC, Comprehensive metabolic, CPK, ordered by Occupational Health Dr. No results given. UNK UNK 1
0176772 10/26/2001 PA 17.0 17 F 10/19/2001 After being vaccinated today this pt developed a sore throat, nasal congestion, and left sided facial swelling. The pt denies any throat swelling or difficulty swallowing. No shortness of breath. No chest pain or chest tightness. the pt is now here for evaluation concerned that she is having an allergic reaction to her vaccination. She returned to the ER on 8/11 with complaints of continued nasal congestion, development of fever and achiness. She called again and said and said that both eyes were bloody looking and swollen and she was vomiting again. She was instructed to come to the office where she also stated that she felt like her joints were stiff in her knees, and a little in other joints. She appears to be somewhat fatigued. She also has subconjunctival hemorrhages suspected from the coughing and vomiting. She has significant rhinorrhea. Her oropharynx shows diffuse erythema of the posterior pharynx. She had developed a fine maculopapular rash throughout that was also petechial on her bilateral lower extremities. It was decided that she had developed a serum sickness like rxn on put on prednisone. Y Y 08/09/2001 08/09/2001 0 Temp 98.8 Pulse 94 Respiration 20, Blood pressure 104/75. Pulse ox 100% on room air. Pt had a rapid strep test which was negative. There were many laboratory tests performed on this young lady so I suggest you look at the report. It had 25 pages. PVT PVT Zyrtec, Flonase, BCP's, Allergy injections NONE Enviornmental allergies 1
0176773 10/26/2001 SC 4.0 4 M 10/25/2001 Local rxn to left arm. Large amount of redness, swelling and warm to touch. Tx with Augmentin Followed up in office in 2 days. Y 10/19/2001 10/20/2001 1 NONE PVT PVT NONE NONE NONE 1
0176774 10/26/2001 GA 42.0 42 F 10/15/2001 The pt experienced palpitations, irregular heartbeat on 10/13 and 10/14. Seen in ER on 10/13 but symptoms subsided during that time and reoccurred approximately 2 hours later. Y Y 10/12/2001 10/13/2001 1 electrolytes - nml, TSH - pending OTH PUB Levoxyl, Serafen, Lo-Estrin NONE multinodular goiter, PMS 1
0176777 10/29/2001 CT 52.0 52 F 10/25/2001 The pt experienced tingling in legs, which increased to shooting nerve pains with memory loss. Treated with Amoxicillin for 6-8 weeks. The annual follow up states, "I still have nervous system shooting sensations and muscle pain. My joint pain is controlled by Voltaren. This is eventhough I was on IV antibiotics x 12 weeks." Y N 04/01/2000 04/01/2000 0 Western blot, eliza - neg PVT OTH NONE NONE 1
0176778 10/29/2001 NJ 51.0 51 F 11/20/2002 The pt experienced a sudden loss of vision, (over night - blurred). The pt experienced a problem with balance and memory. Vision was lost for 3 days following 2nd shot. Diagnosis of multiple sclerosis verified in medical records. follow up report received 11/20/02 states "vision & balance, sudden loss of vision occurred about 4 days after second shot". Per review of medical records: MS (multiple sclerosis) was diagnosed sometime between 10/11/1999 when MRI ordered, and 04/2000. Y N 05/03/1999 05/07/1999 4 CAT scan, MRI, spinal tap PVT OTH Cardizem, Arthrotec NONE osteoarthritis, HBP, Diabetes, Adult onset obesity 1
0176779 10/29/2001 MA 0.2 0 .2 M 10/25/2001 The pt's mom called on 10/24/01 at 11:00 am with a temp of 100.2, was fussy. Given Tylenol and advised to call if there are changes. Y 10/23/2001 10/24/2001 1 NONE PVT PUB NONE NONE NONE 1
0176780 10/29/2001 CA 1.25 1 .3 M 10/12/2001 Pt developed a 12.5 x 10 cm area of redness, a 6.5 x 5 cm area of swelling and tenderness to touch on left lateral thigh. Pt was able to ambulate. Pt was treated with cool compresses for 24 hrs and then warm compresses and with Motrin. Pt was to follow up in 2-3 days. U 10/09/2001 10/10/2001 1 NONE PVT PVT NONE 1
0176781 10/29/2001 IL 3.0 3 M 08/02/2001 Pt developed a red, swollen area on arm, bizarre behavior and mood swings. U 07/31/2001 08/01/2001 1 NONE PVT PVT PPD NONE Malabsorption, peptic ulcer disease, possible IgA deficiency 1
0176782 10/29/2001 TX 0.2 0 .2 M 10/01/2001 Pt had immunization 9/26 and Barium x-ray 9/27. Pt was seen due to rash and diagnosed with urticaria (vaccine vs Barium). Pt was treated with Benadryl, 3cc by mouth every 6 hours. Visit with doctor 4 days after onset revealed rash has resolved. Y 09/26/2001 09/28/2001 2 NONE PUB PVT NONE TX01150 1
0176783 10/29/2001 NJ 30.0 28 M 10/26/2001 flu like symptoms and arthritic pain in knees, ankles , elbows, hands and shoulders. U 04/12/1999 04/15/1999 3 PVT PVT NONE NONE 1
0176784 10/29/2001 DE 42.0 42 M 10/18/2001 Lymerix injection on 9/11. Achiness particularly in legs within 24 hours. No treatment. By 9/17/01 muscles still just a little tender. Hunter wanted vaccination for prophylaxis. Y 09/11/2001 09/12/2001 1 PUB OTH UNK UNK NONE 1
0176785 10/29/2001 NY 42 F 10/24/2001 Felt chills and aches next morning. Left work to rest and slept until 3pm. Visited physician. Body aches, stomach aches. Physician advised pt she had "stomach virus". Pt reports fever. Went to ER. Had diarrhea. Advised to take Tylenol and liquids. Y Y 10/22/2001 10/23/2001 1 NONE UNK UNK Levoxil and Xelexa. Allergic to Codeine 1
0176786 10/29/2001 NY 37.0 37 F 10/25/2001 The client had injection at 13:00. Called at 15:30 and stated "hives on throat, chest and right arm. Client taken by security to health office. Vital signs: temperature 98; P-64; BP-114/70; R-20. Report to MD and administered Benadryl 50mg, IM and called EMS. Pt taken to ER for evaluation. A follow up report received 10/31/2001 adds: Nurse associate of the reporter states she has followed the pt who continued to use Benadryl to control the hives which she has had following the flu shot. This pt has never had a flu shot before. Last report was that she had no worsening of her symptoms; had had hives on her back the morning after she was seen in the ER. Y U 10/25/2001 10/25/2001 0 PUB PUB NONE NONE NONE 1
0176787 10/29/2001 IN 46.0 46 F Pt stated he lost much use of left arm. Pt had stiffness and pain if left arm. Y Y 01/02/2001 01/03/2001 1 PUB UNK NONE NONE 1
0176788 10/29/2001 UT 79.0 79 F 10/17/2001 Pt reports pain, itching, H.A., warmth in right arm from shoulder to elbow 2 hours following injection of Pneumococcal vaccine. Later noticing swelling, redness. Pt notified her physician on 10/16/2001. He prescribed Benadryl 50 mg TID, cold packs, nurse advised Tylenol. U 10/16/2001 10/16/2001 0 NONE PUB PVT Beta Pace 120 Mg - 1 daily Synthroid 88 mg. 1 daily NONE Allergy to aspirin and inflammatory agents, heart arrhythmia 1
0176789 10/29/2001 FL 63.0 63 F 10/17/2001 Pain in arm. A follow up report received 10/31/2001 adds: Reporter states Pt had been to Urgent Care before coming to office. Office notes indicate some warmth at site but no redness or associated symptoms. Pt received no other injection at that date and had no other vaccines in the previous 4 weeks. Y 10/03/2001 10/03/2001 0 PVT UNK Aciphex, Tranzine, Bentylm, Elivil, Claritin, Feoricet, Fosamax, Prevacol, Chloral hydrate, Phenergan NONE Bronchoetasis 1
0176790 10/29/2001 PA 47.0 47 F 10/23/2001 Injection received 10/19/2001, at 1600 pm. On 10/20/2001 at 2:30 pm, noticed swelling and redness at left arm area. Also consist of biceps muscle aching. Described as the size of a 50 cent piece. On 10/20/2001, also developed headache and diarrhea which lasted approximately 1 day and then resolved. Y 10/19/2001 10/20/2001 1 PUB UNK NONE Propandol; Wellbutrin, Multivitamin 1
0176791 10/29/2001 MN 46.0 46 F 10/22/2001 Received a flu shot in the am (10/17/01) Within waking night slept. Went home to sleep came back to work at 10 PM that night. Felt itchy all over her body. Noticed redness but no rash or hives. Took Benadryl. It improved. Took Benadryl. It improved. Took 2 more doses of Benadryl over next 24 hours. Redness went away and 24 hours itching stopped. Y 10/17/2001 10/17/2001 0 PUB PVT Insulin Hemalog Diabetes Asthma, Hypertension 1
0176792 10/29/2001 TX 73.0 73 F 10/01/2001 Rash on arms and thighs on 9/30/01 at 22:30. Took Atarax 10mg prn itching. Y 09/27/2001 09/30/2001 3 NONE PUB PUB Insulin; Lipitor; HCTZ; Synthroid; Prempro NONE Diabetes TX01148 1
0176793 10/29/2001 MA 4.0 4 M 10/25/2001 On 10/24/01 at 11:30, child was brought to ER having a seizure. Temperature was 101F and Advil was given. Seen RN in office for F/U on 10/25/01. Questionable viral illness/reaction to immunization. Y Y 10/23/2001 10/24/2001 1 CBS-Chemistry, Hematology and Urine analysis PVT PUB Medicines for post liver transplant Questionable viral Liver transplant in 1997 1
0176794 10/29/2001 TX 1 .1 M 09/24/2001 Eruption of about 100 blisters on 08/14/2001, about 150 more blisters on 09/12/2001, about 25 blisters on 09/21/2001 and severe itching with no fever. Y Y 08/10/2001 08/14/2001 4 PUB UNK NONE NONE TX01143 1
0176795 10/29/2001 TX 11.0 11 F 09/24/2001 On 09/21/2001, pt received Hep B , 1st dose, IM in the left deltoid. Approximately 4 hours later, client "having trouble breathing" and "difficulty swallowing". Went to ER, X-rays taken showed swelling in throat, per mother. Rx given: Prednisone and Benadryl. No history of food or medicine allergies. Y U 09/21/2001 09/21/2001 0 ER took X-rays PUB PUB NONE NONE NONE TX01144 1
0176796 10/29/2001 TX 4.0 4 F 08/31/2001 Physician of pt called to report that pt came in on 08/29/2001 to her office with left deltoid swollen, erythematous and complaint of itching. No report of pain or fever. Placed on steroid cream. Child returned to doctor office on 08/31/2001 with resolution. Y Y 08/27/2001 08/29/2001 2 PUB PVT UNK UNK Antibiotics for ear infection. TX01145 1
0176797 10/29/2001 TX 11.0 11 M 10/01/2001 Pt RTC within about 15 minutes of administration of vaccines with significant bilateral edema of both sets of eyelids. Complained that started feeling bad with cough and numbness of eyelids. Lungs CTA, no respiratory distress and no hives noted. Y Y 10/01/2001 10/01/2001 0 PUB PVT NONE NONE Allergies TX01146 1
0176798 10/29/2001 TX 3.7 3 M 10/02/2001 Received TC from RN at ER that, per mom, child had seizure in car after leaving the clinic. Went directly to ER and had rectal temp at 103.3, in postictal state. Y Y 10/02/2001 10/02/2001 0 WBC at ER 23.1 PUB PUB NONE Cold One week premature TX01147 1
0176799 10/29/2001 TX 12.0 11 M 09/20/2001 Broke out in hives in evening all over body. Given Benadryl, little relief. Seen by MD on 09/18/2001. IM Solu-medrol and no improvement. Referral to allergist. Seen 09/19/2001. Allergist prescribed Allegra and Zyrtec. Zyrtec to be used in evening if no improvement after Allegra. Rash remained on 09/20/2001. Itching somewhat better. History of allergic reaction in past to food and other allergens. Allergist desires to see child in one month and will test to see if child hypersensitive to vaccine per mother. Mother child to complete hep A series but advised her to follow advise of physician on that issue. Sent mother information on components in vaccines and study history from manufacturer. Was to call back in if rash worsened. No call received. Y 09/17/2001 09/17/2001 0 UNK PUB PUB NONE NONE Had previous allergic reaction to other "things". TX01149 1
0176800 10/29/2001 TX 14.0 14 F 10/04/2001 On 10/02/2001 Hep B#3 given left arm IM; reactions occurred 7:50 am the next morning of 10/04/2001; 5x5 paresthesia (numbness and tingling) in lower back, both arms and left leg; afebrile. Was taken to ER; Prednisone prescribed, no history of allergies to drugs or foods. Y U 10/02/2001 10/03/2001 1 PUB PVT NONE NONE Seasonal allergies. TX01151 1
0176801 10/29/2001 TX 1.8 1 .9 M 10/08/2001 14:10 pm Varicella given SC. in upper outer aspect of right arm - 20 minutes after injection pt developed a 1 cm hive with redness, 3/4 tsp Benadryl given at 14:30 pm. Y 10/02/2001 10/02/2001 0 PUB PVT Allergies to insect bites/inhalants. TX01154 1
0176802 10/29/2001 TX 1.0 1 .2 F 10/11/2001 Mom noticed a few lesions approximately 4 days after receiving varicella vaccine, now with approximately 25 lesions. Tx: Neosporin ointment. Y U 09/17/2001 09/21/2001 4 NONE PUB PUB NONE NONE Allergic to Zithromax TX01155 1
0176803 10/29/2001 TX 12.0 12 F 10/11/2001 Given 2nd Hep B, fainted approximately 5 minutes later. Medication not responsive. Shallow rapid breathing, vomiting. 911 called. Taken to ER. Y Y 10/11/2001 10/11/2001 0 PUB PVT TX01156 1
0176804 10/29/2001 TX 69.0 69 F 09/05/2001 Received tetanus injection on 09/02/2001 in Emergency department following a traumatic injury to her left index finger. Pt seen 09/05/2001 in Wound clinic for follow up. Right upper arm red, hot, indurated and tender. U 09/02/2001 09/05/2001 3 PVT PVT Rocephin with Xylocaine Laceration and dislocation of left index finger Bactrim allergy 1
0176805 10/29/2001 TX 4.0 4 M 09/27/2001 10x14 cm redness, mild, swelling 72 degree after shot (MMR), right thigh. Drugs Benadryl. Y Y 09/07/2001 09/10/2001 3 PVT PVT 1
0176806 10/29/2001 WA 1.0 1 .0 M 10/19/2001 Maculopapular eryth. rash diffuse head to toe. Fever for 3 days before rash, likely oral examination. Y 10/11/2001 10/18/2001 7 CBC oral shifts with UBC 48, 23 sig,76 lymph's, IM. PVT UNK 1
0176807 10/29/2001 GA 0.5 0 .5 M 10/20/2001 One day after DaPT #3, HIB #3 and Hep B #1 developed hives. Y U 10/18/2001 10/19/2001 1 PVT PVT last dose Cefzil 10/18/2001. NONE 1
0176808 10/29/2001 IN 1.0 1 .4 F 10/19/2001 Abscess left hip approximately 1 1/2 inch reddened circle. With mobile mass felt beneath, warm compress to relieve redness/swelling. Y 10/17/2001 10/19/2001 2 PVT PVT NONE Persistent Otitis media 4 mos~DTaP (no brand name)~1~0.00~In Patient|~Hib + Hep B (Comvax)~2~0.00~In Sibling|~DTaP (no brand name)~2~0.00~In Sibling 1
0176809 10/29/2001 NC 11.0 11 M 10/04/2001 Dx: Erythema Nodosum U 09/21/2001 10/02/2001 11 Based on clinical grounds OTH PUB NONE NONE 1
0176810 10/29/2001 FL 3.0 3 F 10/22/2001 Developed varicella. Follow up on 12/14/2001: "No other information given." Y 06/08/1999 10/20/2001 865 PVT PVT UNK Hx: Wheezing 1
0176811 10/29/2001 WI 1.0 1 .5 F 10/22/2001 Febrile seizure evening received 3 vaccines. Y Y 07/30/2001 07/30/2001 0 PVT PVT Started on Amoxicillin URI 1 1/2 weeks - sinusitis. Had febrile seizure 05/2001. febrile seizure~Measles + Mumps + Rubella (MMR II)~1~1.00~In Patient|~DTP + Hib (no brand name)~4~1.00~In Sibling 1
0176812 10/29/2001 WI 3.5 3 M 10/22/2001 Eight spots exposed 3 weeks ago with chicken pox. Afibrile, abdominal pain. Classical chicken pox lesions. Y Y 08/17/2001 10/18/2001 62 PVT PVT NONE NONE NONE NKDA 1
0176813 10/29/2001 FL 52.0 52 F 3 days, post vax, noticed swelling/puffiness of forearms and swollen lymph node on the right armpit. Pt took Benadryl 25mg X 2 and swelling has decreased daily as has the size of the swollen lymph node. Y 10/12/2001 10/15/2001 3 PUB PVT Methotrexate 25 mg lml, 3/4 ml weekly; PPD/Connaught/C0619AA/ID/RFA NONE Psoriasis/Sulfa allergy. 1
0176814 10/29/2001 NY 15.0 15 F 10/19/2001 Chana walked outside after receiving DT booster and passed out. Brought back site office had a generalized seizure called ambulance to ER via Hatzalo ambulance. The follow up received on 2/8/03 states fainting spell/approx 5 minutes after injection. Y Y 06/30/2000 06/30/2000 0 Comprehensive metabolic profile CBC with diff. PVT PVT Claritin C/O allergy symptoms. 1
0176815 10/29/2001 MD 47.0 47 F 10/18/2001 Pt had sweating and weakness 10 minutes after injection. Also nausea within 24 hours. Y 09/04/2001 09/04/2001 0 Travel for prohylaxis UNK OTH Wellbutrin and Klonopin NONE Sulfa drugs 1
0176816 10/29/2001 NY 3 F 10/22/2001 Varicella given in right arm 10/19/2001. On 10/22/2001 mom returned with child. Right arm swollen, large red area, warm to touch. Child complained of itching, no pain. U 10/19/2001 10/19/2001 0 PUB UNK NONE NONE 1
0176817 10/29/2001 NC 11.0 11 F 10/22/2001 From shoulder to elbow red, itchy, pimply rash noticed about 24 hours after vaccine. Benadryl cream applied after consulting with MD. Rash disappeared in 3 hours. Y 09/07/2001 09/08/2001 1 NONE OTH PUB NONE NONE 1
0176818 10/29/2001 MN 30.0 30 F 10/16/2001 The patient called the clinic on 10/12/2001 stating she had an onset of chest pain the same day of the vaccine. The patient stated the chest pain felt like a heart attack. The patient denied SOB, a cough or rash. The patient felt flu-like symptoms. During the phone contact with the patient on 10/12/2001, the patient did not have labored breathing and did not sound distressed. The patient was instructed to follow-up with the ER as soon as possible with the severe reported chest pain. Y U 10/09/2001 10/09/2001 0 UNK PUB PUB NONE NONE NONE 1
0176819 10/29/2001 CT 60.0 F Large local reaction to tetanus diptheria toxoid. Fever and numbness in area. N PVT UNK NONE 1
0176820 10/29/2001 UT 1.0 1 .2 F 09/19/2001 Hives within a few hours of receiving vaccination of hep B second dose. The hives slowly dissipated within 24 hours. Mother treated with Benadryl and watched for difficulty breathing. MD advised by phone not completing series. Y 03/27/2001 03/27/2001 0 NONE PUB PUB Benadryl UT011815 1
0176821 10/29/2001 UT 56.0 56 F 09/21/2001 Pt reports "feeling yucky" 3 hours after hep A shot. Pt complained of diarrhea, nausea, mild breathing problems and fever that went from 99-102.5 that night. Fever on Wed night was higher possibly 105.3, but pt isn't sure she read thermometer right. Fever on Thurs (09/20/2001) was 99. Pt better today, just complained of "low energy". Y 09/18/2001 09/18/2001 0 PUB OTH Meds for Diabetes NONE Diabetes UT012216 1
0176822 10/29/2001 UT 10.0 10 F 10/12/2001 Client returned to clinic 10/12/2001 complaining of pain, redness, swelling and drainage from injection site. From where the area was located on the arm, the hep B injection would have been civen there. Her mother reported client had been scratching the injection site. Y U 09/20/2001 10/12/2001 22 PUB PVT UNK UNK UNK UT011817 1
0176823 10/29/2001 UT 41.0 41 M 10/18/2001 Pt had headaches, body aches and muscle aches, post vax. He was seen by health professional. He states that he still has muscle aches and weakness. He has been referred to an MD for further testing and follow-up. Y U 05/30/2001 05/30/2001 0 NONE PUB PUB NONE NONE NONE UT012918 1
0176824 10/29/2001 UT 0.5 0 .5 M 10/18/2001 Four by five cm area of erythema and papular eruption (almost vesicular) with multiple satellite lesions. Y 10/17/2001 10/17/2001 0 PVT PUB NONE NONE NONE UT010319 1
0176825 10/29/2001 DE 70.0 70 M 10/16/2001 On 08/06/2001 received pneumovax injection. On 08/07/2001, pt complained that his arm was swollen, tongue thick and eyes slow to focus. BP dropped briefly, no treatment except warm compresses to the arm. Y 08/06/2001 08/07/2001 1 PUB UNK Nitro paste, Allegra, MVI, Coreg, Serax, Nexium, Allopurinol, IMDVR, theochron, cozaar, plavix, Asa, Benadryl and demerol. CHF Allergic to Dristan (causes rash) 1
0176830 10/30/2001 F 10/23/2001 A female patient with no previous vaccine reactions, who, in April or May of 2000, was vaccinated with a 3rd dose of hepatitis B vaccine recombinant. Within one month of the 3rd vaccination, the child was diagnosed with a bowel obstruction and the mother reported that the child never returned to "normal". In June of 2000 the child was diagnosed with Coxsackie Virus. At the end of June 2001 the child had muscle weakness and a rash. On 08/15/2001, the patient was diagnosed with dermatomyositis. The patient's mother felt that the dermatomyositis was related to therapy with hepatitis B vaccine recombinant and, as a result, does not want her other children to receive the vaccine. Unspecified medical attention was sought. It was reported that the child is doing better and is expected to recover. Follow up information from a physician indicated that the hepatitis b vaccine recombinant was given one year before the patient got sick and "it was not the RECOMBIVAX HB". Upon internal review, the patient's experience was considered an other important medical event. (OMIC) N 04/01/2000 05/01/2000 30 OTH OTH UNK UNK WAES01101091 1
0176831 10/30/2001 1.25 F 10/23/2001 15 month old female child was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live. It was noted that the child was in good health. Subsequently, ten days later, the child developed a crossed eye and head turn. An ophthalmologic exam was performed and revealed a 10-15 degree esotropia in primary position. a 15 degree esotropia in left gaze, and a orthophoria in right gaze. It was noted that the child had a 10-degree left face turn. It was reported that the left lateral rectus underacted by two to three on a scale of four. The child's pupils reacted normally, and the results of a dilated fundus exam were normal. A cycloplegic refraction revealed + 1.00 sphere OU. The child's vision was central, steady and maintained. A neurological history and examination disclosed normal development and no physical abnormalities except for sixth nerve palsy. A computed tomographic (CT) scan was normal, and during the next three months, the left abducens palsy gradually resolved. At the age of 22 months, the child had an upper respiratory tract infection and another left abducens palsy developed with a head turn to the left and a esotropia in primary position. Neurologic and ophthalmologic exams results were again normal with the gave normal or negative results: CBC, urinalysis, serum electrolytes, serum urea nitrogen determinations, spinal tap, edrophonium chloride test, viral titers for Epstein-Barr and enterovirus. It was reported that the sixth nerve palsy again resolved during the next two months. The authors noted that there have been reports of recurrent sixth nerve palsies, but that none were secondary to immunizations. Y Y Y Y OTH OTH UNK UNK WAES01100301 1
0176835 10/30/2001 NJ 1.08 1 .1 M 10/15/2001 On 5/18/01, the pt developed petechiae and ecchymosis. Platelet count was 2000. Diagnosed with thrombocytopenia. Y 2 Y 04/27/2001 05/18/2001 21 Platelets = 2000 PVT PVT NONE GERD 1
0176836 10/30/2001 ND 5.0 F 10/23/2001 The pt experienced a febrile seizure. Y Y 3 Y PUB PUB seizure NONE 1
0176837 10/30/2001 SC 0.2 0 .2 M 09/20/2001 Within 3 hours of vax, the baby became very lethargic, was staring off in space, did not respond well to mother, had a fever of 100.6 and was admitted to the hospital. Baby was dehydrated and had a WBC count that was elevated. A follow up report received 12/20/2001 adds: 10/18/01: "Pt had lethargy and decreased responsiveness beginning shortly after receiving immunizations. Pt was admitted to the hospital the same day apparently for dehydration, but this is not clear. The dehydration and increased WBCs suggest the child had an intercurrent illness, and the lethargy and decreased responsiveness were unrelated to vaccines given. Continue routine childhood immunization schedule." Y 4 Y 09/13/2001 09/13/2001 0 CBC, urine culture, blood culture, spinal tap, PUB PUB NONE SC0148 1
0176838 10/30/2001 IL 4.0 4 M 10/12/2001 The pt experienced right arm swelling. Y Y 2 Y 10/05/2001 10/07/2001 2 PVT PUB NONE asthma IL01040 1
0176839 10/30/2001 VA 0.6 1 .6 M 10/18/2001 The pt experienced diarrhea, sensitive to sound, hyperactivity, speech stopped, lost eye contact, became withdrawn, and autism. The 60 day follow up states diagnosis of autism unchanged. Y N 11/03/1995 12/01/1995 28 PVT PVT NONE NONE 1
0176840 10/30/2001 WI 1.5 1 .6 M 10/23/2001 The patient's mother called to report the left deltoid injection site is red with a mild temperature. The patient's temperature is 103.4F with congestion. The patient is being treated with Tylenol and Motrin. Y U 10/12/2001 10/22/2001 10 PUB PUB NONE NONE 1
0176841 10/30/2001 MI 0.1 0 .2 F 10/24/2001 The patient started crying at 11:30 am and continued to cry until 4:15 pm. The patient screamed whenever she moved her legs. The patient was fine after 4:15. Y 10/23/2001 10/23/2001 0 NONE PUB PUB Tylenol NONE NONE 1
0176842 10/30/2001 SC 0.7 0 .6 F 10/03/2001 The patient's mother states 3 days after receiving the 1st set of baby shots, the patient was diagnosed with "infantile spasms" and was seen by a Pediatric Neurologist. At birth the patient was diagnosed with decreased muscle tone and was receiving therapy. The patient's mother states that before the shots the patient was moving her arms, smiling and "talking", but now, the patient just looks at her and does not move hre arms or legs. Y N 08/09/2001 08/12/2001 3 EEG PUB PUB Pehnobarb, Topanex descreased muscle tone at birth, developemental delay, seizures. SC0149 1
0176843 10/30/2001 IL 0.3 0 .3 M 10/15/2001 The patient's parent stated the patient broke out in a rash all over his body except his face. The patient was very fussy. The patient was not treated as the rash cleared up on it's own. Y 10/10/2001 10/11/2001 1 PUB PUB NONE IL01041 1
0176844 10/30/2001 SC 1.0 1 .1 F 09/04/2001 The patient's mother describes the patient as pale, listless and refusing food. Mother was instructed to take the patient to her M.D. U 08/29/2001 08/30/2001 1 PUB UNK SC0147 1
0176845 10/30/2001 CA 1.0 1 .0 M 10/19/2001 Post vax, the patient developed induration 3cm x 4 cm with raised erythema. U 10/17/2001 10/17/2001 0 PUB PUB NONE NONE CA010116 1
0176846 10/30/2001 IL 0.3 0 .4 F 10/02/2001 On 08/24/2001 the patient had small raised papules on the leg and arm around the injection sites. Believe this may be from alcohol wipes, not the immunizations. Y 08/20/2001 08/23/2001 3 PVT PUB NONE NONE IL01044 1
0176847 10/30/2001 VA 92.0 92 F 10/19/2001 2 hours, post vax, in the left deltoid, pt developed pruritus of left upper arm. This continued to increase throughout the day and night until we saw her at 10:00 on 10/19/01. At that time, she had diffuse erythema of the left upper arm below the injection site and just above anticubital area, measuring about 10cm. Y 10/18/2001 10/18/2001 0 PVT PVT Fosamax 70mg a week; diltiazem ER 180 q d; Coumadin 2mg 1
0176848 10/30/2001 PA 68.0 68 F 10/11/2001 On 10/9/01, right arm was painful, with swelling at the injection site and developed a temperature of 102F. On 10/10/01, swelling extended to right elbow and right shoulder and was still very red and painful. She was dizzy, could not focus and needed assistance walking. She was trembling and had profuse perspiring. On 10/11/01, swelling had slightly subsided and redness had lessened. She saw an MD. Y Y 10/09/2001 10/09/2001 0 PUB OTH Premarin; Lozol; Vioxx; Prinivil 10mg; Prilosec 20mg NONE High BP; Diverticulitis; Stricture of esophagus 1
0176849 10/30/2001 MN 71.0 71 F 10/23/2001 Pt reported breaking out in hives all over her body a few hours after receiving the Flu Vax. She said she was also itchy. It went away about 4 days later. She did not report the event until today (10/23/01. A follow up report received 11/1/2001 adds: Confirms history of pt breaking out all over body starting a few hours after she received the flu shot. She had no treatment during the worst 4 days while the hives lasted. She failed to report the effect until the 23rd when she returned to the Dr's office for other care. Record is otherwise correct and complete. Y 10/15/2001 10/15/2001 0 NONE PVT PVT Nasonex Suspension; Trazadone; Prevachol; Zoloft; Estradiol Abdominal and chest pain Allergies to Penicillin V and Potassium 1
0176850 10/30/2001 WI 62.0 62 F 10/19/2001 On 10/17/2001 Pt developed red area about 2 inches diameter on left upper arm where injection was given. On 10/18/2001 advised to mark around red area. use ice on arm and take Benadryl. On 10/19/2001 PC tp pt red area smaller, getting better. Y 10/16/2001 10/17/2001 1 PVT PVT Prevachol, Notriptyline, Paxil, Prilosec, Premrcn and Carafati. Hazadone, codeine and IV demerol. 1
0176851 10/30/2001 SC 48.0 48 M 10/25/2001 Pneumonia and Flu vaccines given in same arm 1 inch apart. Pt experiencing severe pain at site. Low grade fever, headache, generalized artnralgia and hylgias. Y U 10/24/2001 10/24/2001 0 NONE OTH PVT Injectible MVI Biz and folate NONE 1
0176852 10/30/2001 CA 4.0 4 M 10/24/2001 Localized allergic Rxn about about 20 cm eryth/imdurated, warm patch on upper right arm. Y Y 10/08/2001 10/09/2001 1 PVT PVT NONE Asthma Small Knot~DTaP (no brand name)~4~1.00~In Patient 1
0176853 10/30/2001 HI 4.0 4 M 10/17/2001 Four year old with onset of full body urticaual rash about 1 hour after receiving influenza vaccine. Y 10/16/2001 10/16/2001 0 NONE OTH UNK NONE NONE Intermittent Asthma 1
0176854 10/30/2001 HI 3.0 3 F 10/19/2001 Left arm swollen, hard and red. Warm to touch. No fever. Instructed to use ice packs, give Motrin 160mg Q6-8 degrees and Benadryl. Y Y 10/16/2001 10/16/2001 0 PVT PVT NONE NONE NONE HI0111 1
0176855 10/30/2001 NC 32.0 32 F 10/24/2001 Reaction 20 minutes post receiving vaccine. Check out "hives- breaking out on face, neck, chest, arms, nausea, weakness, lightheadedness."Self medicated with Tylenol and Benadryl. Did not report allergy to eggs. But states eggs made her sick when she was child 10/24/01. A follow up report received 11/1/2001 adds: Pt had long standing food sensitivity to eggs, hives still present 2 days after vaccination given. Pt's reaction has continued to subside, had no other vaccinations at that date or in the month prior. On no meds, no hx of previous AE's with vaccines. Has been advised not to take flu shot again. Y 10/22/2001 10/22/2001 0 U/A Negative results PUB PVT NONE NONE 1
0176856 10/30/2001 PA 71.0 71 M 10/22/2001 Chest tightness, dizziness, shoulder pain. Renalog injection given in return visit. Y U 10/22/2001 10/22/2001 0 PVT PVT NONE 1
0176857 10/30/2001 MO 45.0 45 F 10/24/2001 Employee complained of jaw pain, slurred speech and then passed out. Difficulty in moving hands and with communicating. Occurred 15 minutes after flu shot. Pt given Benedryl, steroids, Zofran in ED. Pt observed for several hours then released. Y Y 10/01/2001 10/01/2001 0 CT Scan MIL OTH NONE NONE NONE 1
0176858 10/30/2001 TX 18.0 18 F 10/23/2001 Pt received Fluzone at 10:15am. Returned an hour later with swollen right eyelid (upper and lower). No repiratory distress, pain or itching. Awake and alert. Benadry 50mg elixir given and ice pack applied to right eye. No fever. U 10/11/2001 10/11/2001 0 Vitals 108/56 Pulse 70-16 No fever OTH OTH UNK Right eye swelling UNK TX01159 1
0176859 10/30/2001 KS 59.0 59 F 10/22/2001 Had diarrhea, vomiting, muscle aches more severe and headache. Nauseated, ill feeling. Went to Dr. on 10/17/2001 and he gave me Cedox (antibiotic for sinus infection). Y 10/09/2001 10/10/2001 1 OTH PUB Zoloft, Buspar, Prilosec, Antenolol, hormonesand hydrocodone for back and legs. Diarrhea Fragrance, Niacin, Nizeral, Cipro and ploclyco, Morphine and Thirmersol. 1
0176860 10/30/2001 LA 63.0 63 F 10/22/2001 Within 2 hours, post vax, my arm was swollen and I had chills and a temperature of 101F and more, which lasted at least 2 days. Y 10/06/2001 10/06/2001 0 PVT PVT NONE Back and leg pain Temperature and aches~Influenza (Seasonal) (no brand name)~1~35.00~In Patient 1
0176861 10/30/2001 NJ 62.0 60 F 10/26/2001 Approx. 7 days after the 2nd injection, the pt saw her physician on 1/31/00 and from that date on, it has been one referral after another to ascertain whi I got this sudden onset of swelling and pain in her joints. She also has had general malaise. She is presently in physical therapy. She continues to be treated for swelling and pain in her extremities and arm. She takes codeine when pain is bad and Naprosyn Sodium during the day. Both meds are PRN. She also had a large reddened area on her arm that lasted 2 weeks after this vaccine. The 3rd dose resulted in a large red and swollen area at the site of the injection. Y N 01/14/2000 01/21/2000 7 PVT PVT Serevent, Proventil, Flonase, Premarin Asthma 1
0176862 10/30/2001 NJ 61.0 59 F 10/20/2001 The patient experienced very bad arm stiffness, fatigue and Bell's Palsy after immunizations. Y 06/01/1999 PVT UNK 1
0176863 10/30/2001 IA 1.3 1 .4 M 10/17/2001 Post vax, the patient experienced a high fever, a 3" area of redness and swelling around the injection site, his face was red and swollen and he cried continuously. Y Y 10/16/2001 10/17/2001 1 NONE PUB PUB NONE Respiratory problems, facial nerve injury at birth. 1
0176864 10/30/2001 WV 30.0 30 F 10/24/2001 One week following vaccination the patient noted pain from the left axilla, in the left arm down to the elbow and in the left shoulder joint. Y 10/03/2001 10/10/2001 7 NONE PUB PUB Doxycycline, Prednisone NONE Allergies 1
0176865 10/30/2001 NC 4.0 4 M 10/15/2001 Approximately 24 hours after injections, the patient's right arm was swollen, red, hot, and tender to touch. Y Y 10/05/2001 10/06/2001 1 MIL PUB Erythromycin, Amoxicillin NONE NC01093 1
0176866 10/30/2001 NC 65.0 65 F 10/16/2001 Post vax, the patient developed a red, swollen area on the right deltoid. The patient was already on Keflex for a dog bite. Y 10/01/2001 10/02/2001 1 NONE PUB PUB Cozaar, ASA, Premarin, Synthroid NONE HTN, Psoriasis, Menolpause, Hypothyroidism NC01094 1
0176867 10/30/2001 GA 12.0 12 F 10/17/2001 Patient's parent called to report the patient has a red area the size of a nickle where the vaccine was given. The patient is being treated with cold compresses. The next day the rea area is about the size of a quarter, but not quite as red. The following day the area is no longer raised and is about the size of a dime, The patient has been treated wtih Ibuprofen and cool compresses. Y 10/03/2001 10/13/2001 10 PUB PUB NONE Multiple mental and physical disabilities and CP 1
0176868 10/30/2001 AR 5.0 5 M 08/27/2001 Post vax the patient's right upper arm was sore, hot, swollen and red. Y Y 08/24/2001 08/25/2001 1 WBC PUB OTH NONE NONE NONE AR0143 1
0176869 10/30/2001 AR 37.0 37 F 10/05/2001 Post vax the patient reported a large bruised, reddened area with a large knot at the site of injection. U 09/26/2001 09/26/2001 0 PUB UNK NONE NONE AR0144 1
0176870 10/30/2001 AZ 23.0 F 10/15/2001 Post vax, the patient lost work due to a stiff neck, neck pain and enlarged lymph nodes. The patient was diagnosed with reactive adenopathy and myalgias secondary to vaccine reaction. Y Y Cat Scan and Blood work-neg UNK UNK ~Polio Virus, Inact. (PolioVax)~2~23.00~In Patient 1
0176871 10/30/2001 PA 5.0 1 .1 M 10/22/2001 Patient caught disease despite vaccination. Y 04/30/1997 10/22/2001 1636 PVT UNK NONE NONE 1
0176872 10/30/2001 NY 38.0 38 F 09/24/2001 Post vax the patient experienced headaches, fever, dizziness, nausea, diarrhea, raised red spots, blotches and itchiness. U 09/07/2001 09/19/2001 12 Rubeola IgM done 9/24/01 UNK UNK Benadryl, Tylenol NONE Asthma, Bronchitis 1
0176873 10/30/2001 OH 1.75 1 .8 F 10/19/2001 Post vax the injection site became red, swollen and warm to touch. Y Y 10/16/2001 10/16/2001 0 NONE PVT PUB NONE Mild viral illness 1
0176874 10/30/2001 IA 1.0 1 .0 F 10/29/2001 Post vax, the patient developed a maculopapular erythematous rash with itching on the trunk, upper extremities, face and groin. Y Y 10/16/2001 10/23/2001 7 NONE PUB PUB NONE NONE NONE 1
0176875 10/30/2001 MS 0.5 0 .5 F 10/09/2001 The patient experienced prolonged crying, no appetite, a knot in the left leg, redness and soreness. Y Y 10/05/2001 10/06/2001 1 NONE PUB PUB Albuterol, Palgil NONE Breathing condition MS01047 1
0176876 10/30/2001 FL 1.5 1 .5 F 10/25/2001 Post vax, the patient experienced swelling and redness at the site of the injection. Y 10/23/2001 10/24/2001 1 NONE PVT UNK NONE NONE 1
0176877 10/30/2001 NJ 1.5 1 .6 M 10/22/2001 Post vax the patient experienced exanthem, generalized occipital lymphadenopathy and had low-grade temperature 48 hours after the vaccination. Y 10/12/2001 10/21/2001 9 NONE PVT UNK NONE NONE 1
0176878 10/30/2001 SC 15.0 15 F 10/08/2001 The patient became very weak and dizzy about one hour after receiving vaccine. Did not seek treatment. Y 09/29/2001 09/29/2001 0 PUB UNK NONE SC0150 1
0176879 10/30/2001 OH 0.1 0 .2 M 10/25/2001 The patient experienced redness and swelling for 3 days, induration 2x2cm and erythema 2.5cm x 1cm at the injection site. U 10/22/2001 10/23/2001 1 PVT PUB NONE URI NONE 1
0176880 10/30/2001 WA 69.0 69 M 10/15/2001 The patient experienced redness and swelling of the right elbow. The patient was treated with an ace wrap from the wrist to the elbow an elevation. Y 09/21/2001 09/24/2001 3 NONE PVT UNK Inderal, Thyroid Aggrenox, Primidone, ASA NONE Hypothyroid, DJD, Reflux Gastritis, Thalamic Ischemic Stroke, Right hemiparesis and dysarthria 1
0176881 10/30/2001 OK 4.0 4 M 10/17/2001 Post vax the patient's right upper arm was swollen within hours after vaccination. The swelling and redness increased extending up to the right earlobe. The patient was treated with Atarax, Orapred and Tylenol with codeine. Y 10/09/2001 10/09/2001 0 NONE PVT PUB NONE Asthma 1
0176882 10/30/2001 TX 57.0 57 F 10/22/2001 Post vax the patient developed a large area of edema and redness in the area of the injection which was hot and painful to touch. Y Y 10/15/2001 10/17/2001 2 PUB PUB NONE NONE TX01162 1
0176883 10/30/2001 TX 1.0 1 .7 M 10/19/2001 Erythema, swelling and warm to touch. Blister at injection site. Entire upper thigh swollen. 10/17/2001 10/19/2001 2 PVT PUB TX01161 1
0176884 10/30/2001 TX 1.0 1 .3 M 10/19/2001 Erythema, swelling and blisters at injection site. Swelling entire upper thigh, warm to touch. 10/17/2001 10/19/2001 2 PVT PUB TB Test left forearm TX01160 1
0176885 10/30/2001 SD 18.0 18 F 10/22/2001 Pt described rapid heart, tingling fingers and lips, "warm spots on skin". No SOB or swelling. This incident was not witnessed by health care professionals and pt did not seek medical attention. Y 09/12/2001 09/12/2001 0 NONE PVT PUB Allergic to chlorine. 1
0176886 10/30/2001 TX 0 1 M Ten minutes after vaccine given, greater than quarter size red area with a 2 by 3 mm wheal at injection site of varicella on left arm. Benadryl 3 ml po given. Within 10-15 minutes redness had diminished and wheal disappeared. Reviewed signs with mom. Y 10/09/2001 10/09/2001 0 PUB PUB TX01158 1
0176887 10/30/2001 TX 2.0 2 .0 M 10/18/2001 Swelling, erythema () at injection site. Area swollen approximately 3 inches in diameter. Y 10/16/2001 10/18/2001 2 PVT PUB TB Test left forearm TX01157 1
0176888 10/30/2001 WA 69.0 69 M 10/15/2001 Right arm swollen from injection site down to elbow. Treated with ice, Benadryl and elevated. Y 09/26/2001 10/02/2001 6 PVT OTH Lisinopril, lanoxin, Warfarin, Levothryroxine, NTG insulin, gemfibrosil. NONE Diabetes, Afib MR, HTN, Hypothyroid, (Pacemaker)-Bradycardia, CHF- cardiomyopathy. 1
0176889 10/30/2001 AL 32.0 32 F 10/16/2001 Post vax the patient had swelling at the injection site and severe pain to the elbow. The patient was treated with Solu Medrol and given pain medication. On 10/19/2001 the patient states her arm is better. Y Y 10/12/2001 10/12/2001 0 NONE PUB PUB NONE NONE Asthma AL0111 1
0176890 10/30/2001 OH 13.0 13 M 10/23/2001 On 10/22/2001 at 2:10pm guardian phoned office to report pt complained of headache on 10/21/2001. relieved with Tylenol. in am of 10/22/2001, complained of headache, sore throat and soreness in neck. Guardian was advised to take pt to ER and report back to this office. Did not report back. Y U 10/11/2001 10/21/2001 10 PUB PUB UNK UNK UNK 1
0176891 10/30/2001 OH 26.0 26 F 10/23/2001 Pt developed hives and "tight chest" the evening after receiving vaccine. Pt complained of itching once hives developed. Pt has history of asthma. Y Y 10/11/2001 10/11/2001 0 UNK PUB PVT UNK UNK Asthma 1
0176892 10/30/2001 IL 42.0 42 M 09/28/2001 Chest pain following Imovax thought he was having a heart attack even though pain was right side of chest. Cardiac work up was negative. Y Y 08/10/2001 08/10/2001 0 EKG normal PVT UNK NONE NONE NONE 1
0176893 10/30/2001 MO 35.0 35 F 10/15/2001 Began 10/03/2001 noted lymph node swelling femoral area. Soreness then left neck. On 10/05/2001 stiffness and knots in neck, then right side of neck and moved to right femoral area over a few days each area on 10/09/2001 felt sick. On 10/10/2001 vomiting and low grade fever. On 10/11/2001 just red then 10/12/2001 fever 101. 10/14/2001 last pm hot complained of itching. Rash now. U 10/01/2001 10/03/2001 2 PUB PUB NONE NONE Hay fever MO2001054 1
0176894 10/30/2001 MO 1.0 1 .7 M 10/17/2001 On Tuesday 10/09/2001 in the evening, child had a convulsion. Took to ER. Had 101.2 fever was examined ad no problem found. Lab done, child sent home. No more convulsions, had fine pink rash the next day all over body except face, lasted 2 days. No further problems. Gave child Augmentin for respiratory condition. Y Y 10/01/2001 10/09/2001 8 Had blood test, x-ray of chest and urine test. PUB PUB NONE NONE NONE MO2001053 1
0176895 10/30/2001 WA 69.0 69 F 10/15/2001 24 hour upper arm swelling, red, tender, and hot. Y 09/20/2001 09/20/2001 0 NONE PVT UNK NONE NKDA; Afib; DJD 1
0176896 10/30/2001 NY 12.0 12 M 09/28/2001 Feeling shaky 30 to 45 minutes after vaccine administration. Two to three hours after face pale and clammy. U 09/27/2001 09/27/2001 0 NONE PUB PUB Ritalin UNK Component of hot dog, chest pain, unspecified contact dermatitis. 1
0176897 10/30/2001 ME 4.0 4 M 10/23/2001 Very large (10cm) red raised lesion six days after administration. Y 10/11/2001 10/15/2001 4 PVT UNK NONE NONE 1
0176898 10/30/2001 MI 4 F 10/19/2001 Erythemaous papular rash 2.5 by 1.5 cm lateral thigh. Y 10/17/2001 10/18/2001 1 NONE PVT PVT NONE NONE Asthma controlled 1
0176899 10/30/2001 ME 1.0 1 .4 M 10/19/2001 Three by five cm erythematous swollen area at site of injection left thigh. Y Y 10/16/2001 10/18/2001 2 PVT PUB Otitis Media NONE 1
0176900 10/30/2001 NJ 1.2 1 .1 F 10/17/2001 7 days, post vax, and after Amoxicillin started, the pt developed a rash, fever and irritability. She had extensive urticarial rash on forehead to lower extremities with purple areas. This lasted 3 days and was thought to be MMR reaction versus drug reaction to Amoxicillin. Y Y 09/21/2001 09/28/2001 7 CBC; Blood culture-neg; PT/PTT-wnl PVT PVT Amoxicillin started on 9/21/01 Otitis Media 1
0176901 10/30/2001 IL 9.0 9 M 10/03/2001 On 10/3/01, Hep-B was given at school. The child felt ill and vomited approx. 15 minutes after the shot. He stated that he felt nauseated. Eyes were dilated, skin was pale, warm and dry. Approx. 10:00 AM, he went home with mom. At 13:45, his mother called and stated that he has a flat blotchy rash on his ears, legs and arms are tingly and has chest pain when lying down. The injection site is swollen and painful. She called the MD and he stated to let him know if he worsens. At 12:30, the child states that he feels much better. Rash is gone. Y 10/03/2001 10/03/2001 0 NONE PUB PUB Claritin; Singulair Asthma Allergy to corn and dust IL01043 1
0176902 10/30/2001 IL 18.0 18 M 10/04/2001 The patient experienced cold, clammy perspiration, became unconscious with rolling of eyes upward and petit mal seizures for a few seconds. The patient regained consciousness and was seen in the ER. The patient was diagnosed with syncope due to shots. Y Y 10/04/2001 10/04/2001 0 PUB PUB Tuberculin PPD NONE NONE IL01042 1
0176903 10/30/2001 OH 4.0 4 M 10/23/2001 Fever about 4pm on 05/01/2001. Next morning right arm swollen from above shoulder to the elbow, red and hot with rash all over red, faded and returned. Fever 103-105 for about 4 days. Rash started out blotchy, then pinpoint. Doctor was seen on 05/02/2001. Three days later treated in ER for dehydration. Y Y 05/01/2001 05/01/2001 0 PUB PUB NONE UNK OH0058 1
0176904 10/30/2001 IL 4.0 4 F 09/03/2001 Red, raised rash on lower back 24 hours after vaccination. Warm, red, tender area left arm, deltoid region. Dry cough, "runny nose" and anorexia (poor appetite). Y Y 08/20/2001 08/20/2001 0 NONE PUB PUB PPD left forearm NONE NONE IL01039 1
0176905 10/30/2001 SC 11.0 11 F 10/11/2001 Mother reports client developed redness and knot at site of injection. Mother described redness as "streak" around injection site. Client taken to doctor 10/10/2001. Diagonal with local reaction to second Hep B shot per MD and will be reevaluated in the next 2-3 months (see attached copy). Y 10/08/2001 10/09/2001 1 PUB PUB UNK UNK 1
0176906 10/31/2001 TX 0.2 0 .2 F 10/11/2001 The child was in the office for well check up. The pt was cleared by doctor as a well child. given 2 month immunizations. No reaction was noted at that time. Discharged to home with Mom and grandmother. Stated cause of death as SIDS. Y 09/06/2001 N 09/05/2001 09/06/2001 1 autopsy states findings did not reveal a cause of death - classified as "undetermined" PVT PUB NONE NONE TX01163 1
0176912 10/31/2001 0.2 0 .2 F 10/26/2001 On 4/9/99, the infant received her 2nd injection of Engerix-B. On 5/11/99, the infant received her 1st dose of rotavirus vaccine (Rota Shield, Wyeth Labs) and inactivated poliomyelitis virus vaccine (IPOL, Aventis Pasteur) and her 2nd injection of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Acel-Imune, Lederle Labs) and Haemophilus influenza type b conjugate vaccine (Hib-Titer, Lederle Labs). The physician reported that the infant began vomiting and having diarrhea on 5/16/99, 37 days following receipt of Engerix-B and 5 days following receipt of other vaccines. On 5/17/99, she developed "colicky" abdominal pain and bilious emesis. She was taken to the local ER where evaluation was "non-diagnostic". The infant was hospitalized. Later on 5/17/99, she became more "colicky" and passed a bloody stool. She was transferred to a tertiary care center. A series of upper GI (GT) x-rays were negative. Contrast enema revealed intussusception, which was reduced by the enema. The physician reported that the infant recovered. The infant's attorney reported that the infant was lethargic on 5/15/99. On 5/16/99, she "screamed repeatedly and exhibited stomach rumbling". In the ER on 5/17/99, a stool specimen was reportedly positive for occult blood. Her temperature was reportedly 99.3F and her fontanelles were "slightly sunken". The infant was administered unspecified IV fluids. The attorney reported that the infant developed intermittent abdominal pain and fussiness and was seen in the local ER on 5/23/99, 44 days following the administration of Engerix-B and 12 days following the other vaccines. The attorney alleged that "the infant experienced episodes of screaming and pain for a period of almost a year." The reports were considered to be life-threatening and involved persistence of significant disability or incapacity. The infant reportedly recovered from intussusception. Outcome of the screaming, abdominal pain and fussiness were not specified. Y Y Y 3 Y Y 05/11/1999 05/16/1999 5 HCT on 5/17/99-10.4 (increased); Electrolytes-unremarkable; Contrast Enema-Intussusception; Upper GI Series-neg; Ultrasound (NOS)-neg on 5/23/99. OTH OTH NONE GI Reflux disease 20010253701 1
0176916 10/31/2001 OH 1.25 1 .3 F 10/26/2001 Local erythema with pain at injection site, 24 hours, post vax. Y 10/25/2001 10/26/2001 1 PVT PVT 1
0176917 10/31/2001 CA 36.0 36 M 10/19/2001 Pt developed red, swollen and hard area at injection site measuring 6.5cm X 9cm, with a red streak 8cm X 4cm at upper arm. Symptoms started (achy and feverish) on 10/18/01 with localized reaction beginning on 10/19/01. Y Y 10/17/2001 10/18/2001 1 OTH PUB Nasonex nasal spray; Nyquil NONE NONE 1
0176918 10/31/2001 GA 31.0 31 F 10/30/2001 15 minutes, post vax, pt complained of arms and face tingling. Pt had local reaction of pinkness and slight edema, ice applied. Vitais WNL. No SOB. Pt observed for 2 hours after injection. No further symptoms. Y 10/30/2001 10/30/2001 0 PVT OTH Allergy to bee stings 1
0176919 10/31/2001 CA 28.0 27 F 10/19/2001 Within 6 hours erythematous area measuring about 2 cm in diameter was noticed on left arm at injection site. 24 hours later the erythema now measured 7 cm, area was hot to the touch and very swollen, non tender. Condition persisted for another 24 hours before, subsiding. Y 10/11/2001 10/11/2001 0 MIL MIL NONE 1
0176920 10/31/2001 IA 57.0 57 F 10/17/2001 Stiffness and extreme pain, in neck, back, knees, feet. hands, started within about 2 hours of receiving shot. Pain did not start recede till 10/16/2001. Was the worst pain ever experienced by me. Could not get up without help. Ibuprofen Lortabs. Y Y 10/11/2001 10/11/2001 0 PVT PVT Cozaar, Glucophage, Premarin, Lamisil, Glucophage, Prozac slight cold DM, HTN, Allergy to feathers 1
0176921 10/31/2001 MN 88.0 88 F 10/24/2001 10/18/2001 5 PM resident vomiting, temp 101.3 RD had 5 cm raised area. Blotchy areas on thighs and groin. Ran a temp through 10/20/2001, vomiting noted only on 10/18/2001. Y Y 10/16/2001 NONE OTH PVT Timoptic of drops ASA 81 mg 64.E. NONE dementia post CVA with allergies. 1
0176922 10/31/2001 AK 50.0 50 F 10/12/2001 Flu shot, fever/chills, myalgia, nauseated, headache and flushes. Y 10/07/2001 10/09/2001 2 NONE OTH PVT GERD AK200161 1
0176923 10/31/2001 AK 44.0 44 M 10/16/2001 Patient's left deltoid, axillae and left chest wall, swollen, red and inflamed. Painful and impedes use of left arm. Symptoms developed 3 days after receiving pneumococcal vaccine in left deltoid. Seen by MD and dx'd with infection and started on antibiotics. Y U 10/09/2001 10/12/2001 3 PUB PUB NONE AKZ00162 1
0176924 10/31/2001 AK 39.0 39 F 10/15/2001 Friday 9:30am given flu and pneumonia in right and left aut thighs at pt request. At 5:30pm while in a meeting, experienced sharp pain in left leg (given pneumo in LAT), left the mtg and went home and took pain meds. Slept through the night, slight pain in the morning. At about 2:30pm on Saturday while doing work outside, pt noticed a rash like hives on her upper body and back. Still red on Monday. Y 10/12/2001 10/12/2001 0 PUB PUB NONE Allergy to cats Passed out~Vaccine not specified (no brand name)~~0.00~In Patient AK200163 1
0176925 10/31/2001 FL 61.0 61 F 10/25/2001 Shoulder joint pain and restricted range of motion. Y 10/22/2001 10/22/2001 0 OTH PVT Actigall NONE 1
0176926 10/31/2001 FL 40.0 40 F 10/26/2001 Light headedness, dizziness, heavy feeling and throbbing in affected arm. Treated with Benadryl 50 mg PO. Y 10/22/2001 10/22/2001 0 OTH PVT Claritin and Oral contraceptive NONE Allergy to dust, animal fur and fragrance trees. 1
0176927 10/31/2001 FL U 10/25/2001 Light headedness, dizziness followed by syncope lasting approximately 2 minutes treated with Benadryl 50 mg PO. Y Y 10/25/2001 10/25/2001 0 OTH PVT Tamoxifen and Prozac S/P Lumpectomy for Breast Cancer treated with CMF last dose 1.5 years ago. 1
0176928 10/31/2001 FL 35.0 35 F 10/25/2001 Muscular and shoulder joint pain with restricted range of motion. 11/07/01 Patient diagnosed with bursitis in shoulder of arm vaccinated. Y N 10/22/2001 10/22/2001 0 OTH PVT Lithium and Seroquel NONE 1
0176929 10/31/2001 AL 57.0 F 10/18/2001 Rash at injection site and upper left arm. Treatment with Benadryl cream. 10/16/2001 10/16/2001 0 UNK UNK Allergies to Steroids and Zestril. Patient states she took Flu vaccine in 1999 and 200 without any problems. 1
0176930 10/31/2001 AL 30 F 10/18/2001 Swollen face and eyes. Treatment with 25mg Benadryl and referred to MD. 10/17/2001 10/18/2001 1 UNK UNK UNK allergies. No egg allergy. 1
0176931 10/31/2001 IN 68.0 68 F 10/26/2001 Left upper arm from elbow to half way up shoulder, pink warm, and swollen and tender to touch. Family MD thought it was an allergic reaction and pt allergies. Talked with pt 10/25/2001 and she states it is almost better. Y 10/16/2001 10/17/2001 1 OTH OTH NONE Breast Cancer 1
0176932 10/31/2001 CA 32.0 32 F 10/17/2001 Painful, can't raise right arm above shoulder level. Swollen around site of injection. Given 60mg Toradol FM, Naprosyn 500mg and Vicodin. U 10/16/2001 10/16/2001 0 PVT PVT 1
0176933 10/31/2001 WV 35.0 35 F 10/30/2001 SOB, itching, coughing, red rash on chest, arm and face. Treated with Akid, Singulair, Prednisone and Allegra. Y Y 10/25/2001 10/25/2001 0 NONE PVT PVT Tylenol and Prilosec NONE NONE Emesis~Measles + Mumps + Rubella (MMR I)~1~0.00~In Patient 1
0176934 10/31/2001 FL 54.0 54 F 10/17/2001 Area of injection became reddened and it change on 10/14/2001. On 10/15/2001 and 10/16/2001 with redness and itching. Improved by 10/17/2001. Y 10/14/2001 10/14/2001 0 PUB PVT Codeine allergy 1
0176935 10/31/2001 NJ 65.0 65 F Fever 102 degree, malaise, body aches and treatment. Y 10/24/2001 10/25/2001 1 PVT UNK 1
0176936 10/31/2001 NJ 36.0 36 F 10/29/2001 5 cm X 3 cm warm erythematous area at vaccination sites. Therapy with reflex 500 mg twice daily. Y U 10/26/2001 10/27/2001 1 OTH UNK 1
0176937 10/31/2001 FL 34.0 34 F 10/18/2001 Aching, woke up in middle of night feeling like I was going to pass out. Feeling really flush feeling. Nauseated, Ill feeling passed in about 24 hours. Y 10/10/2001 10/11/2001 1 OTH OTH Flovent, Claritin, Flonase, Cenestin Asthma, Hypoglycemia Osteoporosis 1
0176938 10/31/2001 CT 28.0 28 F 10/30/2001 Right nasal herpes simplex outbreak. Pt previously unexposed/symptom free. Therapy - Famvir. Y 10/23/2001 10/25/2001 2 PVT PVT NONE NONE NONE 1
0176939 10/31/2001 NH 38.0 38 M 10/24/2001 On the afternoon of 10/19/01, the arm that the yellow fever was taken in, there was itching, swelling and a large red circle with about a 4" papular rash. No fever. Y 10/19/2001 10/19/2001 0 NONE MIL MIL IPPD/PMC/C0835AA/ID NONE NONE 1
0176940 10/31/2001 NJ 32.0 29 M 10/31/2001 Medical history and concurrent conditions were not provided. The pt had no known drug allergies. Concurrent medications included Zyrtec 10 mg daily and doxycycline 100 mg twice daily for unspecified indications. The pt received his first injection of Lymerix on 01-OCT-1999. The physician reported that he had not seen or spoken to the ptsince that time. In October 2001, the physician was notified as part of litigation proceedings that the pt experienced "persistent worsening of aches and pains" in the ankles and feet, "floaters' (NOS0, fatigue and malaise. The pt reportedly claimed that these events were caused by the administration of Lymerix. As of 14-OCT-2001, the pain in the ankles and feet was "persistent". The outcome of the "floaters", fatigue and malaise were not provided. Comment: The reporter indicated that the pt received Lymerix lot LY13099; however, this is not a valid lot number. The adverse event "worsening pain in ankles" does not meet ICH serious criteria but is being submitted as an expedited report be special FDA request per the June 28, 200 letter. 10/01/1999 OTH OTH Zyrtec and doxycycline Medical history and concurrent conditions were not provided. 20010255081 1
0176941 10/31/2001 WA 1.5 1 .5 M 10/23/2001 The patient had a red, raised rash starting at his trunk and spreading out toward his limbs for two days. The rash did not bother the patient and there was no treatment. Y 09/28/2001 09/28/2001 0 PVT PVT Cold 1
0176942 10/31/2001 NJ 0 .2 M 10/25/2001 Mom states baby got shots on 08/08/2001 at around 12 noon. At 9pm, baby began crying a lot and mom could not calm him down, no matter what she did to console him, it didn't help. Crying at least 3 hours, probably more. Mom brought baby to ER that night. Baby was checked and found to be healthy, no noted fever. Y Y 08/08/2001 08/08/2001 0 NONE PUB PUB NONE NONE NONE 1
0176943 10/31/2001 GA 0 .2 M Rash started on 10/19/2001. Vaccines administered on 10/18/2001. Y Y 10/18/2001 10/19/2001 1 PVT OTH NONE NONE 1
0176944 10/31/2001 AK 0 .6 M 08/17/2001 08/16/2001 at 2:30 am, pt had temp 101 with "jerking" seizure activity. CHA prescribed Tylenol/Motrin. Case reported on RMT later that morning. Infabt was fine that morning about 9:30 am. Was sent to pediatrician on 08/17/2001. Older sibling with seizure disorder. Infant had a febrile seizure last month with pneumonia. Y Y 08/15/2001 08/16/2001 1 OTH PUB NONE Malformation right aurticle AK200159 1
0176946 10/31/2001 TX 0.75 0 .8 M 10/25/2001 Immediately post vax, the patient let out a sob, "had no breath left", seemed to turn blue for 5-6 seconds and then started breathing again. The patient was very drowsy afterward and slept about 15 minutes in the clinic and then 1 1/2 hours at home. Y 10/24/2001 10/24/2001 0 NONE PVT PUB Runny nose NONE TX01168 1
0176947 10/31/2001 TX 0.75 0 .8 M 10/25/2001 The patient spit up his formula shortly after arriving home from the clinic. He spit up another unusual amount before going to sleep around 8:30 that same night. This was an extremely early time for the patient to go to sleep. The patient awoke about 9:00 am and did not call out as he usually does. The patient did not reach out or have his usually bubbly personality. He lay in the bed after awaking and made whining sounds. That PM it was noted that the patient's left cheek bone area was swollen. On 10/18/2001 the patient remained unresponsive and the swollen cheek now had a red line it it, which seemed to be inside the skin. The patient does not interact with others and will often sit and stare. When in his high chair he will lean over and lay his head to the side. The patient also coughs a lot now. The patient is now no longer active in his bath or when he is having his diaper changed. As of 10/23/2001, the patient has not regained his previous disposition. The patient is mopey, whines alot, leans or falls over slowly while being held as if he is going to sleep, but he is wide awake. He has spurts of joviality then returns to a lethargic state. He no longer wakes up playing. Y 10/16/2001 10/16/2001 0 PVT PUB Iron, Zantac and Reglan. Congenital syphillis, developmental delay. TX01167 1
0176948 10/31/2001 NC 0.1 0 .1 M 10/19/2001 Two days after the vaccination, the patient developed a papular rash on his forearms. 10/16/2001 10/18/2001 2 NONE PVT PUB NONE NONE NONE 1
0176949 10/31/2001 AZ 23.0 33 F 09/14/2000 Painful to lift left arm. Painful to drive car. Painful to push down on an object MD visit on 09/16/2001 indicated 1. No loss of function in left arm. 2. No neurologic deficit. Y Y 08/31/2001 09/01/2001 1 PUB PVT NONE 1
0176950 10/31/2001 NJ 1.0 1 .0 M 10/02/2001 Pt had fever 103-104 for 7 days followed by a diffuse mobilization rash. No other complication. Y Y 09/17/2001 CBC, ESR, fl. culture. PVT PVT TB Test NONE NONE 1
0176951 10/31/2001 CA 1.0 1 .1 M 10/29/2001 Post vax the patient developed a measles like rash. U 10/19/2001 10/28/2001 9 PUB PUB NONE NONE 1
0176952 10/31/2001 MO 3.0 3 M 10/26/2001 10/10/2001 pt presented for DTap and Varicella Vaccination. On history parents reported Toby "had a cold". Day 13 (10/23/2001) 1 maculopapular lesion on buttock, Day 16 about is maculopapular lesion. (Us cab bed (2) with fluid. U 10/10/2001 10/23/2001 13 PUB PVT NONE "a cold" NONE 1
0176953 10/31/2001 TX 50.0 50 F 10/25/2001 On 09/03/2001 the patient found it hard to swallow and breath, had extreme hot and cold spells, generalized weakness, dry mouth and shortness of breath. On 09/06/2001 the previous symptoms worsened and the patient also had a headache, sore throat and dizziness. Y U 09/02/2001 09/03/2001 1 NONE PVT UNK Cut on left knee Allergic to wasps and yellow jackets. 1
0176954 10/31/2001 MO 4.0 4 F 10/22/2001 Patient's mother reported the patient developed warmness and redness to the left upper arm on 10/19/2001, which became more red, hot and very hard by 10/20/2001. Reports redness and warmth continues today, 10/22/2001, but not as severe and hardness resolved. U 10/18/2001 10/19/2001 1 PUB PUB Ear infection NONE MO2001055 1
0176955 10/31/2001 CA 10.0 10 M 10/25/2001 The patient developed diffuse, erythematous, granular rash on his arm in a 4cm wide pattern radiating from injection site, consisting of very tiny vesicles, closedly packed and grainy to feel. These symptoms began 2 days post vax and lasted 4 days with a low grade fever and fatigue. Y 10/18/2001 10/21/2001 3 PVT PVT NONE NONE NONE 1
0176956 10/31/2001 IN 12.0 12 M 10/24/2001 The pt developed a red discoloration of skin from shoulder to wrist on his right arm which was warm to touch. He complained of a headache within 1 hours, post vax. His mother is to take pt to the doctor today for evaluation. Y 10/23/2001 10/23/2001 0 NONE PUB PVT Severe Asthma 1
0176957 10/31/2001 CO 5.0 5 F 10/19/2001 On 10/17/2001, at 8:00 am the patient complained of body aches and abdominal pain. The patient felt warm to the touch, but her temperature was not taken. The patient vomited 6 times today, has had no food or liquid all day, and has been fatigued. On 10/18/2001 the patient ate soup and had no more vomiting. Y 10/16/2001 10/17/2001 1 NONE PUB PUB Advil NONE NONE CO01021 1
0176958 10/31/2001 AK 8.0 8 F 10/15/2001 Mom reports that pt complained of tenderness at site on Friday. Sat. night 2 areas, hive-like, were at the site about 1 inch by 2 inches; these merged to a hot, red, raised area, on Sunday. ER was called but no visit made. child was given Benadryl on Sunday night. On Monday the area was palm-sized, but not as red or hot. Benadryl given again X 1. Y 10/12/2001 NONE OTH PUB NONE NONE Reaction to PCN 4 years ago. AK200164 1
0176959 10/31/2001 AK 17.0 17 F 10/28/2001 Received 4 shots at 4 PM on 9/24. Complained of numbness in left upper arm on 9/25. Saw Dr on 9/25. Treated with Advil. Continued to be difficult to move and sore for several days. Y Y 09/24/2001 09/24/2001 0 PUB PUB NONE NONE AK200160 1
0176960 10/31/2001 67.0 66 M 08/02/2001 Severe cellulitis at site of injection. Y U 08/02/2001 UNK UNK 1
0176961 10/31/2001 CA 4.0 4 M 10/24/2001 Swelling and pain of right bicep after vaccination. CL Mid biceps circumference = 22 cm, R = 26 cm. Small bullas surrounding vesicles at site of injection. Y 10/22/2001 10/23/2001 1 PVT PUB NONE NONE NONE ~Summer/spring enceph (no brand name)~~2.00~In Sibling 1
0176962 10/31/2001 TX 4.0 4 F 10/18/2001 The pt woke up on 10/16/01 and had redness and a hard knot to thigh. Mom called school nurse to look at it and the school nurse said there was a large red, hot area on thigh and painful to touch. The school nurse referred him to MD. Mom couldn't get child to MD so went to ER. He was dx'd with allergic reaction and given Benadryl and Augmentin. He never had a temperature. By 10/18/01, almost all of the redness and hardness was gone. On 10/23/01, mom states "no redness noted". Y Y 10/15/2001 10/16/2001 1 NONE OTH PUB NONE NONE NONE TX01169 1
0176963 10/31/2001 TX 4.0 4 F 10/22/2001 Site swollen and red. U 10/19/2001 10/21/2001 2 PVT PUB NONE NONE TX01166 1
0176964 10/31/2001 TX 2.0 2 .5 F 10/22/2001 Site swollen, red, hard and blister bump on left upper thigh. U 10/19/2001 10/21/2001 2 PVT PUB NONE NONE TX01165 1
0176966 10/31/2001 ME 5.0 5 M 10/25/2001 Redness, warmth, and itching persisting for 10 days. Y 10/15/2001 10/16/2001 1 PVT PVT NONE NONE 1
0176967 10/31/2001 CA 5.0 1 .2 M 10/25/2001 classic shingle (Zoster of dermatone) of left T 8-9 dermatone. Y 05/22/1997 10/10/2001 1602 NONE PVT OTH 1
0176968 10/31/2001 NY 33.0 33 M 10/17/2001 Mylagia, fever, chills, status post Td booster on 10/06/01 for injury to index finger. PE showed 12 cm area . Inflamation and induration of right deltoid site. On 10/9/01 dx of cellulitis made and treated with Keflex. By 10/16/01 clinically improving. Follow up 12/14/2001: "Contact hospital medical records department." Y Y 10/06/2001 10/07/2001 1 NONE PUB OTH Vasotec NONE High blood pressure 1
0176969 10/31/2001 NY 18.0 18 F 10/29/2001 Pt states she had reaction on 09/08/01 consisting of rash and edema of arms, face, legs, feet. Pt states she was tx with Benadryl. Pt states rash lasted for 2 weeks with itching. C/O still felling itchy. Y U 08/23/2001 09/08/2001 16 OTH OTH Augmentin NONE NONE 1
0183773 10/31/2001 UT 50.0 50 F 10/31/2001 Hive on left wrist, immunization give in left arm. 4mg chlorpheriramune give. Y 10/31/2001 10/31/2001 0 NONE OTH PVT prevacid, Zocor NONE 1
0176972 11/01/2001 MO 12.0 F 10/29/2001 Information has been received from a physician concerning a female pt who was vaccinated with a 2nd dose of Hep-B vaccine recombinant (yeast). Subsequently, the pt experienced an anaphylactic reaction and was hospitalized. No further information was provided. Additional information has been requested. F/U states: Information has been received from a physician concerning a 12 year old female pt with severe asthma and environmental allergies who was vaccinated with a 2nd dose of Hep-B. He indicated that about 1 1/2 hours after receiving the vaccine, she went into cardiac arrest, was resuscitated and transported to the hospital. The pt was intubated and placed on a ventilator for several days. The physician stated that the child is fine now and has had follow-up visits to the clinic. It was noted that the physician "did a skin test to Recombivax in the clinic and the results were positive". Additional information has been requested. Y U Diagnostic lab-(+) skin test for Recombivax OTH OTH UNK Allergy; Asthma WAES01103048 1
0176973 11/01/2001 NY 28.0 28 M 01/22/2002 Information has been received from a physician concerning a 28 year old Haitian male who on 10/9/01 was vaccinated with pneumococcal vaccine 23 polyvalent. On 10/11/01, the pt was hospitalized for the following other unrelated pre-existing conditions: aplastic anemia, prostatic abscess, hematuria, sepsis, colitis and a tuberculosis pleural effusions. On 10/12/01, the pt developed a severe injection site reaction described as severe swelling and induration from the right deltoid to his mid-forearm. On that same date, the pt suffered from hemorrhagic cystitis secondary to Klebsiella infection, bibasal pneumonia and developed an intracranial hemorrhage. As of 10/19/01, the pt was on a ventilator and was doing very poorly. A chest X-ray on that same date showed a suspicion of infilitration in both lung bases and a clinical correlation was suggested. The pt was being treated with piperacillin sodium (+) tazobactam (Zosyn), gentamicin and metronidazole (Flagyl). On 10/21/01, the pt died. The cause of death. The cause of death was intracranial hemorrhage. The reporting physician did not feel that the pt's hemorrhagic cystitis and intracranial bleed were related to his pneumococcal vaccine. Additional information is not expected. Y 10/21/2001 Y Y N 10/09/2001 10/12/2001 3 chest X-ray -10/19/01 - Suspicion of infilitration in both lungs bases; Compute Axial - 09/25/01 - Increase in size of left pleural effusion; Acid-fast bacilli stain -09/04/01, Urine culture -10/11/01 UNK UNK UNK Aplastic anemia; Colitis; Hematuria; Pleural Effusion; Prostatic abscess; Sepsis; Tuberculosis WAES01101833 1
0176978 11/01/2001 F 10/29/2001 Information has been received from a consumer concerning her daughter who on 3/20/01 was vaccinated with a 2nd dose of Hep-B vaccine recombinant (yeast). The mother reported that "within months" of vaccination, her daughter "developed a liver condition". It was noted that the pt experienced "increased liver enzyme levels, jaundice, fever and an enlarged and inflamed liver". Her gall bladder was removed because it "shut down". It was noted that the pt had been hospitalized several times. It was reported that the caller did not know the name of the vaccine and did not know if it was Hep-A or Hep-B. The caller was very difficult, threatened legal action, and refused to provide demographics. She disconnected the call before a legal address was able to be obtained. No further information is available. Y Y Y U 03/20/2001 06/01/2001 73 Hepatic function tests on 6/1/01-increased OTH OTH UNK WAES01103328 1
0176979 11/01/2001 U 10/24/2001 Information has been received from a hospital pharmacist concerning an adult hospital employee who on 9/17/01 was vaccinated with the 1st dose of Hep-B vaccine recombinant (yeast). On 10/2/01, the pt presented to the hospital with an itchy rash on the arms and trunk of the body. The pt was dx'd with pityriasis rosea. In follow up reported that it had been determined by an emergency room physician and an Infection Control Nurse that the pityrissis rosea was not associated with hepatitis B vaccine recombinant but were associated with a detergent or soap that the patient had used. Further, the patient had made a full recovery and continued with the Hepatitis B vaccine recombiant series. Upon internal review, the pityriasis rosea was considered an other important medical event. Additional information is not expected. Y Y 09/17/2001 10/02/2001 15 UNK UNK UNK UNK WAES01101826 1
0176980 11/01/2001 MI 2.0 2 .5 M 10/24/2001 Information has been received from a healthcare professional concerning a 4 year old male pt who on 6/17/97, 8/4/97 and 4/17/98 was vaccinated with the 1st (lot 621000/1554D), 2nd (lot 620758/1402D) and 3rd (lot 622790/1036E) doses of Hep-B vaccine recombinant (yeast), respectively. It was noted that on 11/18/99, the pt was vaccinated with 1 dose of MMR (lot 628004/1173H). On 6/3/01, the pt was dx'd with autism. It was noted that no current medications have been prescribed by the PCP. The pt's mother indicated that her son was a normal child until he received these 4 shots. Additionally, it was reported that the parents expressed concerns about the thimerosal content in the vaccine because of the mental delays experienced by their son. FOLLOW-UP information has been received from a physician who reports that the patient has autism and the mother is checking into all his vaccines as a possible cause the physician does not feel that there is any connection. Upon internal review, autism was determined to be an "Other Important Medical Event". No further information is availble. Y N 11/18/1999 06/03/2001 563 OTH OTH Antibiotic allergy WAES01101225 1
0176983 11/01/2001 VA 82.0 82 F 10/30/2001 A pharmacist reported that an 82 year old female vaccinated with Pnu-Imune 23 was subsequently hospitalized with a "shoulder infection". On 10/24/01, the pt received an injection of Pnu-Imune 23 to the left deltoid; on 10/25/01, she developed a swollen arm. On 10/25/01, she saw an orthopedic specialist and was admitted to the hospital with an infection of the left shoulder and underwent surgery. It was noted that the pt received a flu vaccine (Aventis Pasteur) to the same arm on 10/18/01. No further information was provided. Y Y U 10/24/2001 10/25/2001 1 UNK PUB PUB UNK UNK Arthritis (NOS) HQ7750329OCT2001 1
0176985 11/01/2001 FL 1.0 1 .0 M 02/11/2002 Information has been received from a licensed practical nurse concerning a 12 month old male with otitis media and no known allergies who on 9/27/01 was vaccinated SC in the right thigh with a first dose of MMR II (lot 637424/0024L). Concomitant vaccinations on 9/27/01 included a first dose SC in the left thigh of varicella virus vaccine (638728/0237L) and a first dose IM in the left thigh of Prevnar (480502). There were no other concomitant medications. On 10/3/01, the pt developed a temperature of 101-102 and became fussy. On 10/4/01, the pt's temperature was 103 and again he was very fussy. On 10/5/01, the pt was fussy; the mother administered Tylenol and laid the pt down. At 8:45 that evening th ept was cool to touch and he experienced a seizure. He was transported to the hospital (transport took approximately 15 mins). He had a temperature of 104 and was admitted to the hospital for 24 hrs observation. Unspecified lab work was drawn and "something was detected in the blood culture" which resulted in the pt being placed on antibiotics. It was noted that the "events continued until the morning of approximately 10/6/01," and the pt recovered. Additional info has been requested. Y 1 Y 09/27/2001 10/03/2001 6 NONE OTH OTH Unspecified lab work was drawn and "something was detected in the blood culture". Otitis media WAES01101821 1
0176986 11/01/2001 UT 1.0 0 .5 M 10/17/2001 Mercury poisoning, deterioration began around 12-18 months of age. Mercury chelation started on 5/01. The annual follow up states, "Autism spectrum disorder-mercury poisoning. We have spent over and look now on therapies and biomedical treatments for pt. He is finally able to communicate some, but has a long ways to go. Requires an aide in school and still does five hours of ABA a day outside of school." Y N 10/23/1996 05/12/1997 201 Blood tests; organic acids; various test to identify patterns in mercurialism. PVT PVT Antibiotics Ear infections, runny nose NONE ~Vaccine not specified (no brand name)~~0.00~In Sibling 1
0176987 11/01/2001 CA 1.25 1 .3 M 10/11/2001 Pt was seen for a well visit at 09:30 and received MMR and HIB at about 12:30 to 13:00. He developed a fever and was given Tylenol and was put down for a nap. At about 17:00, he awoke from his nap with a generalized tonic/clonic seizure which lasted about 8-9 minutes. He was taken to ER by EMS with a fever of 104F on arrival. He was treated with Cefotan. Diagnosed was UTI Y Y 4 Y 10/10/2001 10/10/2001 0 CBC; LP-neg; CT Scan-enlarged bifrontal subarachnoid spaces, otherwise neg; CXR-neg; cultures-all neg PVT PVT NONE History of RAD 1
0176988 11/01/2001 TN 0.5 0 .5 M 10/08/2001 Temperature increased to 104F, was fussy, had bulging fontanel and was vomiting. Treated 2 days with IV Rocephin. Pt's recovery to be determined. Y Y 2 Y 10/05/2001 10/05/2001 0 WBC-400; 50% polys; Neg gram stain, protein, glucose, cultures; Lumbar Puncture; Normal CSF culture done PVT PVT Reglan; Zantac; Pulmicort NONE Possible penicillin allergy 1
0176989 11/01/2001 CA 0.3 F 10/23/2001 Pt developed pallor, was hypotonic and hyporesponsive. Y Y 1 Y CBC-neg; UA-neg; Lytes-neg; CXR-neg PVT PVT NONE URI NONE 1
0176990 11/01/2001 NJ 45.0 44 M 10/24/2001 Pt developed pain and swelling in feet, pain in legs, feet, back, shoulders and neck, in joints and muscles. He had difficulty concentrating, memory loss and headaches. He also had excessive fatigue and sleeping. The annual follow up states, "Inability to concentrate, fatigue, memory loss, pain and stiffness in leg muscles, stiffness in neck, pain at toe, knee, hip, shoulder, back and neck joints. Swelling of toes and bottom of feet at toes. Left arm can't be raised at shoulder above about 8 o'clock. neck movement limited to about 60 degrees arc left to right. The limitations seem to be physically constrained and not just limited because of pain. A follow up report received 11/13/2001 adds: Vaccine provider states that pt was a participant in a clinical trial for Lymerix. He received placebo in 1995 and 1996. He was in the Lymerix group for injections on 04/28/1997, 06/03/1997 and 04/29/1998. He was in a Lymerix booster group for injection on 11/01/1999. The pt's complaints have been communicated to trial contact, FDA, manufacturer, etc., per vaccine provider's office. Another follow up report received 11/13/2001 adds: Pt stated that he was evaluated by a rheumatologist who stated that pt's symptoms could not be the result of Lyme disease or Lymerix. He was treated by this doctor with pain medications. The pt was later evaluated by a Lyme specialist who told the pt he had chronic Lyme disease that was present prior to the Lymerix vaccination and was aggravated by the vaccination. Pt is being treated with antibiotics and has improved. Y N 01/01/1999 08/01/1999 212 PVT OTH NONE NONE 1
0176991 11/01/2001 MS 0.17 0 .2 M 10/18/2001 Pt developed oral thrush, constipation, diarrhea and lethargy. Pt had long term neurological damage. Child is dx'd with Heavy Metal Toxicity; Severe/Profound Autism. Requires 24 hour supervision. Seizure Disorder requires medication for Mental conditions/Severe/Profound Mental Retardation. Has been institutionalized for 10 years. Pt had MMR on 5/1/87. Follow up report received 12/19/02 states "I.Q.= 11, Adaptive Age 1.7, Chronological Age=16 years, 22 months, Generalized seizure disorder, Mood disorder, anxiety disorder, Nonverbal, severe/ profound Autism, Sleep Disorder, Patient has been institutionalized for 10+ years and will never live outside of an institution. Patient requires 24 hours supervision. Severely brain damaged." Y N 03/17/1986 03/17/1986 0 Pt had 100% heavy metal representation in baby hair. PVT PVT NONE NONE NONE 1
0176992 11/01/2001 CA 23.0 23 F 10/24/2001 Pt received vaccine at 13:45 and 20-30 minutes later, experienced hot flush, wheezing, cough, dyspnea, tongue swelling and shortness of breath. Pt returned to BAS. Vital signs at 14:20; BP-143/72; Pulse-72; Respirations-20 and temperature was 97.9F. She was administered 1.0cc Epi and 25mg Benadryl and O2 therapy. Pt's breathing improved and she was sent to NHCP for further treatment. Y Y 1 Y 09/18/2001 09/18/2001 0 MIL MIL 1
0176993 11/01/2001 NY 4.0 4 M 10/25/2001 On 5/30/01, the child went into a coma. He was unresponsive, had low breathing ability and seizures. To date, he is on 4 drugs and still has seizures. Approx. 5 days prior to hospitalization, he had a fever of 104F for 2 days. He was lethargic and slightly delirious. The annual follow up states seizures. Despite trying all seizure medications and brain surgery this July 2nd, my son still has recurrent seizures and n ow learning disabilities. Y Y Y 23 Y N 04/17/2001 05/27/2001 40 PVT OTH 1
0176995 11/01/2001 NY 80.0 80 M 10/23/2001 3 hours after the pt received the flu and pneumococcal vaccines, the pt had a sudden onset of fever and productive cough. He called me on 10/4/01 and we began Amantadine 50mg and I saw him on 10/5/01 and heard fine, inspiratory crackles, right greater than left, at the base of the lung when present. Chest X-rays showed pulmovascular congestion with cardiomegaly and new bilateral focal infiltrates consistent with pneumonia. Continued on Amantadine and Toquin 400mg po daily was added. He is much improved on 10/15/01 exam. Y Y Y 10/01/2001 10/01/2001 0 CXR-pulmonary vascular congestion and cardiomegaly PVT PVT colchicine; Norvasc; Coumadin; propantheline; Zocor; hydrochlorothinzide NONE HTN; Bio-Pressive Aortic rep; increased PSA; gout; tremor; SSS-VVI pacemaker. 1
0176996 11/01/2001 LA 77.0 77 F 10/15/2001 Pt developed erythema, warmth and tenderness of injection site of pneumovax within 48 hours. She was admitted to the hospital by another MD after worsening cellulitis. She recovered completely. Y Y 08/27/2001 09/01/2001 5 PVT PVT Pravachol PCN, Demerol and E-Mycin allergies. 1
0176997 11/01/2001 KS 55.0 55 F 10/23/2001 The pt was seen on 10/03/01 for exam. She was well and was given Pneumovax and flu vaccine, both in the right shoulder. She then developed fever up to 102.4F on 10/5/01, had sweats, chills and a headache. She also had erythema and pain in the left shoulder. Y 10/03/2001 10/03/2001 0 PVT PVT Pepcid; Naprosyn; Pepcid Complete NONE NONE 1
0176998 11/01/2001 UT 73.0 43 F 10/19/2001 Pt developed redness, heat and slight swelling on right arm, where pneumococcal vaccine was given. Ice applied X 1. U 10/16/2001 10/17/2001 1 PUB PUB Effexor; Synthroid; Premarin; Morbic; Prevacol; Bu-Scar; Zyprexa; levorex; methotrexate NONE Irritable bowel 1
0176999 11/01/2001 KS 64.0 64 M 10/12/2001 About 15-20 minutes, post vax, he got real dizzy and terribly ill. He saw doctor for nausea and vomiting and got a suppository. By 10/1/01, he had to go to ER. He had inner ear infection that had turned into impetigo on ear. On 10/4/01, he was sent to ER and dx'd with Bell's Palsy. He is still suffering from vertigo and depression. Y N 09/24/2001 09/24/2001 0 PUB PUB gemfibrozil; Voltaren; Prilosec; Hyspar; Ambien; Zyrtec; orphenadrine; Accolate; garlic; Vitamin E 1
0177000 11/01/2001 WI 66.0 66 M 10/22/2001 Pt reports receiving influenza and pneumococcal vaccines on 10/16/01. Beginning on 10/18/01, a light rash developed over ankles and feet. By 10/19/01, the rash was raised, red on ankles, feet, stomach and chest. No pustules or open lesions. He reports that he has generalized pruritus but no pain. He was encouraged to see his PCP for dx. Y N 10/16/2001 10/18/2001 2 PUB PVT Paxil 20mg/day; Flonase 1-2 puffs a day Hayfever and allergy to fresh water fish 1
0177001 11/01/2001 AS 46.0 46 F 10/13/2001 Pt was dizzy and drunk with bad taste in mouth. Y 10/02/2001 10/02/2001 0 PUB PVT NONE NONE 1
0177002 11/01/2001 NY 52.0 52 F 10/31/2001 Pt had cough and shortness of breath at 10 PM. Runny nose at 4 PM and Temperature at 5 PM. Stuffiness by 8 PM. After 12 hrs all symptoms lessened. Y 10/23/2001 10/23/2001 0 NONE OTH UNK NONE Childhood asthma-ongoing to age 15 yrs. 1
0177003 11/01/2001 MI 75.0 75 M 10/18/2001 flu vaccine was given on 10/18/01 at 9:30 AM in the school based Health Center. It was then discovered that the vaccine had expired on 06/01. The client was notified and he denied any symptoms or effects. The Health Dept was notified as well as the manufacturer. The client's family Dr is aware and agreed that the client should be revaccinated, client to return next week. Y 10/18/2001 NONE PUB PUB Blood pressure medication NONE Hypertension 1
0177004 11/01/2001 TX 44.0 44 F 10/22/2001 Post vax the patient developed a knot in the left deltoid that night. The next day the patient had a hot, large swollen area and some difficulty breathing. The patient was diagnosed with a moderate allergic reaction. The patient experienced wheezing at the time seen and was treated with Medrol dose pack. Y Y 10/20/2001 10/20/2001 0 NONE PVT PVT Premarin NONE 1
0177005 11/01/2001 MI 37.0 36 F 10/23/2001 45 minutes after the injection the patient had swelling of the upper left arm with pain. The area was 3 in x 4 in. Ice was applied to the site and the patient was referred to community care clinic where she was instructed to continue ice and was gived Motrin and Ultram for pain. Y U 10/08/2001 10/18/2001 10 OTH PVT Lo/Ovral, Ventolin, Inhaler, Levbid, Zoloft, Allegra, Pantenol NONE Asthma, Colitis, Seasonal Allergies, Anxiety 1
0177006 11/01/2001 WI 67.0 67 M 10/17/2001 Patient has red, warm, aching area on the right upper arm since 10/16, which measures 7" x 8". The patient had a temp. Area of redness is increasing. The patient will take Benadryl, apply ice, and start antibiotic if area gets larger. There is no temperature today. Y Y 10/16/2001 10/16/2001 0 PVT PVT ASA, Atenolol, Zocor, FeSO4, Glucosamine Chondroitin NONE Allergy to yellow dye, hypertention, hypothyroid, hyperlipidemia, CAD, stroke 1
0177007 11/01/2001 ME F 10/25/2001 The patient experienced an itchy, macular papular rash on her arms, back and chest. Y U 10/24/2001 10/24/2001 0 NONE OTH OTH Vioxx, Allnatol, Paxil, Zanax NONE NONE 1
0177008 11/01/2001 SD 7.0 7 F 10/12/2001 Hives began on knees this a.m. and have spread all over her body. Patient is being treated with Epinephrine and Claritin. Y 10/11/2001 10/12/2001 1 NONE PVT PVT NONE NONE Strep 1
0177009 11/01/2001 WI 78.0 78 F 10/22/2001 On 10/17/2001 the patient experienced right upper quadrant pain and gas. On 10/18/2001 in the P.M. the patient developed hives and itching of the arms and legs. This continued occasionally through 10/21/2001. Y 10/16/2001 10/17/2001 1 NONE PVT PVT Tagamet, Synthroid, Maalox, Allegra NONE Allergies, Sulfa, Doxycycline, Penicillin, Erythromycin, Floxin 1
0177010 11/01/2001 MA F 10/25/2001 Post vax, the patient experienced a red area below the injection site the size of a silver dollar. The area was warm to the touch but was not raised. The patient feels fine. U 10/23/2001 UNK UNK O'Laughlin Home Care Pharmacy 1
0177011 11/01/2001 NJ 71.0 71 F 10/19/2001 Post vax the patient developed a diffuse maculopapular rash. Y Y 10/11/2001 10/12/2001 1 Dermatologic Evaluation PVT PVT Rash on arms and legs Codeine 1
0177012 11/01/2001 MO 21.0 21 F 10/26/2001 Post vax, the patient had a large 9x9cm, red square which was tender and warm. Y U 10/23/2001 10/23/2001 0 NONE PVT PVT Albuterol, Prozac, Coestna, Imitrex NONE Asthma, Migraine 1
0177013 11/01/2001 IL 52.0 51 F 10/23/2001 The patient has pain in her upper left arm, with a burning sensation down to the elbow. The patient's temp has been 101F for 2 days. There is swelling at the injection site. The patient is breathless, and feels "a weight on her chest". The patient has general body aches. The patient is self-medicated with Tylenol and has had the flu shot in the past without problems. Y 10/16/2001 10/17/2001 1 PUB PUB Claritan D NONE Allergy to dander, dust mites and codeine 1
0177014 11/01/2001 OR 58.0 58 M 10/25/2001 The patient developed knots in his legs 2 days after receiving the flu shot. The knots were gone by the next day. The patient started with a fever, headache, chills, and congestion that evening. The patient has alot of muscle and joint soreness at the present time. U 10/19/2001 10/21/2001 2 PUB PVT NONE NONE NONE 1
0177015 11/01/2001 OR 73.0 73 F 10/25/2001 The patient had itching at the injection site and became anxious. Blood pressure was 180/90 and the patient complained of tingling around the lips and a dry, tight throat. The RN contacted the MD and the patient was treated with Benadryl at the site. The patient was monitored for 30 minutes and felt better. The blood pressure reading was 134/78. The patient was instructed to see an MD if further problems or go to the ER if trouble with breathing. Y 10/16/2001 10/16/2001 0 OTH PVT UNK NONE The patient has other allergies but none to latex, thimersol or other flu reaction. 1
0177016 11/01/2001 OR 20.0 M 10/25/2001 The patient's blood pressure spiked to 190/100 within 20 minutes post vaccination. The patient's face was red and then pale. The patient saw MD at his office and was diagnosed with vasovagal response to the medication. The patient still had a headache the next day. Y 10/23/2001 10/23/2001 0 OTH PVT NONE NONE NONE 1
0177017 11/01/2001 MI 64.0 64 M 10/22/2001 The patient has shoulder pain, leg weakness and insomnia. The patient is being treated with Naprosyn and Klonopin. N 09/24/2001 10/05/2001 11 Shoulder x-ray - Negative PVT PVT NONE COPD, HTN, Hypothyroidism, and High Cholesterol 1
0177018 11/01/2001 MA 54.0 54 F 10/23/2001 Tmax 10:30 Y Y 10/17/2001 10/18/2001 1 PVT PVT MS 1
0177019 11/01/2001 NH 63.0 63 F 10/25/2001 Approximately 2 hours post vax the patient returned to the office with large hives and welts on her extremities and trunk and pruritus. Y U 10/24/2001 10/24/2001 0 NONE PVT PUB NONE Otitis Media NONE 1
0177020 11/01/2001 UT 72.0 72 M 10/20/2001 The patient has redness and swelling over the injection site. U 10/20/2001 10/20/2001 0 NONE OTH PUB NONE Chronic Rhinitis 1
0177021 11/01/2001 FL 65.0 65 F 10/25/2001 On 10/25/01 at 8:50 AM, returned to clinic with complaints of fever, chills, nausea and diarrhea. Pt also had general muscle aching which started @ midnight. Also complained of right deltoid pain and it appears bruised and slightly swollen @ injection site. CBC was repeated. Y U 10/23/2001 10/25/2001 2 10/23/01 WBC 7.5 and UA was negative. On 10/23/2001 prior to injections, temperature was 99.3 PVT PVT Klonopin, Premarin, Vioxx, Prevacid, Percocet, Prozac, sulfa, codeine NONE Osteoarthritis, degenenerative disc and anxiety 1
0177022 11/01/2001 NY 71.0 71 F 10/19/2001 The patient experienced arm pain lasting all night. The patient has a headache and aches all over. The patient had a previous reaction in 1993 to flu vaccine. The patient has received the vaccine yearly since then with no ill effects. Y 10/16/2001 10/18/2001 2 PVT PVT Celebrex, Hydrodiuvil, Insulin, Inderal, Tomoxifen Breast Cancer Motrin, Claritin 1993~Influenza (Seasonal) (no brand name)~~0.00~In Patient 1
0177023 11/01/2001 NY 48.0 48 F 10/23/2001 Post vax, the patient experienced an anaphylactic reaction, including tightening of the throat and dizziness. The patient was treated with epinephrine with good result. Symptoms were resolved within a few hours, although some wheezing remained for a day. Y 10/01/2001 10/01/2001 0 PVT PVT NONE NONE NONE 1
0177024 11/01/2001 KY 23.0 23 F 10/26/2001 Approximately 12 hours post vax, the patient experienced a fever of 104, a headache, nausea, vomiting and body aches. These symptoms lasted 2 days. Y 10/02/2001 10/03/2001 1 NONE PUB UNK NONE NONE NONE 1
0177025 11/01/2001 MO 31.0 31 F 10/25/2001 30 minutes post vax the patient experienced itching, noticed a rash, and then felt her tongue getting thick. The patient was treated in the ER with an injection in the hip and was advised she probably had a reaction to some component of the vaccine. Y Y 10/10/2001 10/10/2001 0 NONE OTH PVT Birth Control Pills, Intel Inhaler, Zyrtec, Serovent, Singulair NONE Asthma and hypothyroidism 1
0177026 11/01/2001 TX 66.0 66 F 10/23/2001 Post vax, the patient experienced swelling in the left arm. Y Y 10/22/2001 10/22/2001 0 PVT PUB 1
0177027 11/01/2001 MN 40.0 41 F 07/18/2001 The patient received vaccination 12/28/2000. On 01/01/2001 the patient developed hives "all over the body" and wheezing. The patient was treated with albuterol, prednisone, Tagamet, Zantac, Accolate, Zyrtec, Allegra and 2 other unspecified antihistamines. The reporter states the hives are resolved with prednisone, but return when the prednisone is stopped. U 12/28/2000 01/01/2001 4 UNK PUB PVT Synthroid, Zyrtec NONE UNK HQ2062414JUN2001 1
0177028 11/01/2001 GA 61.0 60 F 09/06/2001 The patient was vaccinated 11/08/2000. Concomitant medication included Synthroid, estrogen and Prevacid. Subsequent to the vaccine, the woman developed pain at the injection site that keeps her awake. No additional information was available as of the date of this report. U 11/08/2000 UNK OTH OTH Conjugated Estrogens, Prevacid NONE UNK HQ4378208AUG2001 1
0177029 11/01/2001 HI 20.0 19 M 04/20/2001 7 syncopal episodes lasting less than 1 minute over 11 months (last one in 6/00). Episodes began with heat exhaustion during road march in late February or early March/2000. Second episode occurred in 4/00, again with 12 mile road march. Our pt had evaluations by cardiology, pulmonary, endocrine and psychology specialists and no etiology has been identified as a cause. Another soldier in his unit was discharged and had syncopal episodes as well. Y U 01/11/2000 03/01/2001 415 Holter monitor; ECG; EHG; EKG; PPT's all tests were nml; Labs-all nml MIL MIL NONE NONE NONE 1
0177030 11/01/2001 TX 39.0 39 F 02/19/2001 "Started having problems with right elbow and started dropping her weapon." U 12/03/1999 12/17/1999 14 UNK MIL MIL UNK UNK NONE 1
0177031 11/01/2001 TX 35.0 35 F 02/19/2001 Pt reports a history of headaches which had always been relieved with aspirin. States that after receiving the 1st Anthrax shot she began to get consistent headaches unrelieved by aspirin. U 03/26/1999 CT of head0"bilateral ethmoid, sphenoid and frontal sinusitis" MIL MIL UNK UNK NKA 1
0177032 11/01/2001 TX 26.0 26 M 05/09/2000 Onset of symptoms on 5/1/00 at 19:30 with headache, fever and chills, numbness in upper extremities, tingling in fingers, whole body ached and had joint pains, diarrhea, fatigue, restlessness and dizziness. Y 05/01/2000 05/01/2000 0 MIL MIL NONE 1
0177033 11/01/2001 CA 0.5 0 .5 M 10/09/2001 Pt received DTaP, HIB, Hep B and Prevnar. Before mom left room with infant he had a blanching, blotchy macular rash on face. Pt paths well. No other symptoms. Rash resolved within half hour. Y 09/21/2001 09/21/2001 0 PVT PVT NONE Conjunctivitis NONE 1
0177034 11/01/2001 IN 0.36 0 .4 M 10/28/2001 10/26/01 at 3:30 pm child developed rash on cheeks, by evening rash spread all over body. Child has been on Amoxicillin approximately 2 weeks. Child taken to ER. Dr said rash could be from one of the vaccinations or the medication. Child given stronger type of Benadryl and late evening rash gone. As of 10/23 child doing ok. Y Y 10/16/2001 10/16/2001 0 NONE PUB PUB Amoxicillin NONE NONE IN200124 1
0177035 11/01/2001 MA M 10/01/2001 Pneumococcal bacteremia 08/27/2001. Febrile seizure. Y Y Blood culture PVT UNK 1
0177036 11/01/2001 NH 1.0 1 .4 M 10/23/2001 About 20 minutes after Prevnar #3 pt had return of head tic. This tic started at 9 months of age about 3 days after Prevnar #2. The tic never progressed and completely stopped three months prior to Prevnar #3. Pt completely healthy and not compromised by the tic. It has decreased but is still present. N 10/18/2001 10/18/2001 0 NONE PVT PUB NONE NONE NONE head tic~Pneumo (Prevnar)~2~0.00~In Patient 1
0177037 11/01/2001 NM 0.5 0 .5 M 10/03/2001 Grandmother stated that pt developed a rash over his chest, tummy and back several hours after immunizations given. They took him to the ER. He was given Benadryl and Atarax in ER and a prescription for Atarax and Prednisone. Low grade fever and no rash noted to face and arms or legs per grandmother. No problems at injection sites per grandmother. Y Y 10/02/2001 10/02/2001 0 NONE PVT PUB NONE NONE 1
0177038 11/01/2001 CA F 10/23/2001 Pt developed diffuse papulomacular rash lasting two weeks and accompanied by fever 1 week after receiving measles vaccine. Y 09/26/2001 10/03/2001 7 PUB PUB NONE NONE NONE 1
0177039 11/01/2001 MI 0.6 0 .4 F 10/23/2001 Pt was seen on 9/6/01. Mother reported staring episodes, jerking of arms, decreased social interaction and crying more since immunizations. Pt was seen by neurology 9/7/01 and diagnosed with tuberous sclerosis and infantile spasms. Y U 08/24/2001 08/25/2001 1 9/7/01-EEG confirmed infantile spasms PVT PVT 1
0177040 11/01/2001 CO 0.5 0 .5 M 10/22/2001 DTaP and IPV, Prevnar (3rd dose each) given 10/01/2001. Child had febrile seizure 10/02/2001, followed by 2nd nonfebrile seizure 10/03/2001. Both seizures were tonic () less than two minutes. Has also had two episodes of nonfebrile staring (1-2 minutes). Y Y 10/01/2001 10/02/2001 1 EEG pending PVT PVT NONE NONE 1
0177041 11/01/2001 TX 6.0 6 M 10/19/2001 On right anterior thigh, pt developed a 16 cm diameter area of redness, increased warmth and mild swelling. He was started on Keflex for 7 days. U 10/16/2001 10/17/2001 1 NONE PVT OTH Allergy shots NONE Allergic rhinitis ~Pneumo (Prevnar)~1~4.00~In Sibling 1
0177042 11/01/2001 TX 4.0 4 F 10/17/2001 On right anterior thigh, pt developed a 12 cm diameter area of increased redness and warmth with minimal swelling. Pt is currently on Zithromax suspension. U 10/16/2001 10/17/2001 1 NONE PVT OTH Zithromax Upper respiratory infection NONE ~Pneumo (Prevnar)~1~4.00~In Sibling 1
0177043 11/01/2001 CA 0 .2 M 10/01/2001 Non stop crying for 4-5 hours then fussy all night long. No fever. Better the next day. Y 09/27/2001 09/27/2001 0 PVT PVT NONE NONE NONE 1
0177044 11/01/2001 CA 1.0 1 .6 M 10/01/2001 Pt developed swelling in right thigh that evening, by time of doctor visit 09/29/2001 there was 5cm induration and 13cm erythema. Able to walk, not painful; non-toxic. Y Y 09/27/2001 09/27/2001 0 PVT PVT NONE NONE NONE 1
0177045 11/01/2001 CA 0 .7 M 10/08/2001 By day after shot, developed temp 103 max 104 on 09/27/2001. Leg red and swollen. No vomiting. Better by 09/28/2001. Y 09/25/2001 09/26/2001 1 NONE PVT PVT NONE NONE 1
0177046 11/01/2001 CA 0.5 0 .5 F 10/25/2001 Pt developed generalized lesions that were most suspicious for urticaria. Y U 10/18/2001 10/24/2001 6 PVT PUB NONE NONE NONE 1
0177047 11/01/2001 MN 2.0 2 .8 F 10/19/2001 Pt developed marked localized redness, swelling and pain in a 10 x 15 cm area on left deltoid with a 2 cm diameter central area that was slightly raised. The whole area was hot to touch. U 10/16/2001 10/17/2001 1 NONE PVT OTH NONE NONE NONE 1
0177048 11/01/2001 NJ 63.0 63 F Pt developed arthritis in knees, hips, shoulders and neck. She was diagnosed with polyarthritis or polymyalgia rheumatica by Clinic. She took Lodine and Celebrex without effect. She has had arthroscopic surgery on both knees. N 04/16/1998 PVT OTH NONE NONE 1
0177049 11/01/2001 PA 40.0 40 F 10/22/2001 On 4/27/01, pt developed achiness in all joints that persisted for approximately 3 weeks. On 5/26/01, the achiness returned and persisted for 2-3 weeks. From 6/25/01 until the date of report, the achiness has persisted for approximately 60% of the time. On the date of report, pt had a lot of pain in jaws, elbows and wrists. Y N 04/26/2001 04/27/2001 1 5/10/01 Western blot-no Lyme infection PVT OTH 1
0177050 11/01/2001 RI 56.0 F Two hours post vax, pt developed shaking chills and some chest pressure. Over the next 2 days pt had nausea and was hot and cold. U 04/08/1999 04/08/1999 0 OTH OTH Sulagen, Natural Tears, Estratest, Lacrilube Probable Sjogren's; osteoarthritis 1
0177051 11/01/2001 MI 1.25 1 .3 M 10/04/2001 Approximately 3 hours post vax, doctor's office received a call from parents that pt had developed hives, red, itchy eyes and wheezing. Parents treated pt with dose of Atarax and nebulizer treatment of Albuterol and Intal. Pt's symptoms subsided by 10 PM the same evening and did not recur. Y 09/26/2001 09/26/2001 0 NONE PVT PVT Atarax, Albuterol, Intal NONE Reactive airway disease; eczema 1
0177052 11/01/2001 MD 1.0 1 .5 M 10/01/2001 Pt received DTap #4, IPV #1, HiB #4 with Hep B #1 and Varicella. In about 5 minutes pt mom called attention to rash on pt back, pt fussy/crying, rash also appeared on cheeks. MD assessed pt and ordered Epinephrine 1:1000 0.1ml SC given (pt had no stridor, no wheezing). Improved within 5 minutes. Y 09/27/2001 09/27/2001 0 PUB PUB NONE NONE NONE 1
0177053 11/01/2001 TX 4.0 4 F 10/04/2001 Pt given IPV SQ in right thigh, area became red, hot, hard and swollen within 10 minutes. Treatment: Benadryl and Motrin given, ice pack applied, swelling down in 30-40 minutes. Y 10/04/2001 10/04/2001 0 Normal PUB UNK NONE Deaf 1
0177054 11/01/2001 MD 29.0 29 M 10/23/2001 10/21/2001 presented with lighter colored pigment changes over back and shoulder area. No open areas noted. Y U 10/15/2001 10/21/2001 6 Advised 10/23/2001 to see primary MD. OTH PVT PPD NONE ASA 1
0177055 11/01/2001 MI 1.0 1 .2 F 10/22/2001 Red vesiculopapular lesions on right thigh. Y 10/01/2001 10/19/2001 18 PVT PVT NONE NONE NONE 1
0177056 11/01/2001 AZ 4.0 4 M 10/24/2001 Left upper arm erythema, slight swelling with warm to touch started yesterday afternoon. MD gave Cefzil 250mg BID, Benadryl 12.5 25mg at 10prn and warm compresses. Y U 10/22/2001 10/23/2001 1 PVT PVT NONE Feeding problem NONE 1
0177057 11/01/2001 WV 3.0 2 .0 M 10/23/2001 Post vax the patient broke out with chickenpox. Y 02/18/2000 10/19/2001 609 PVT PVT Cold Premature twins 1
0177058 11/01/2001 WV 3.0 2 .0 F 10/23/2001 The patient broke out with chickenpox. Y 02/18/2000 10/18/2001 608 PVT PVT Cold Premature twin ~Varicella (Varivax)~1~3.00~In Sibling 1
0177059 11/01/2001 MA F 10/26/2001 Post vax the patients experienced redness and swelling of the left deltoid in an area 9cm x 10cm. Y 10/24/2001 10/26/2001 2 PVT PUB NONE NONE NONE 1
0177060 11/01/2001 MN 1.5 1 .5 M 36 hours post vax, the patient developed a red, swollen area at the injection site. U 10/22/2001 10/23/2001 1 NONE PVT UNK NONE Undescended testicle 1
0177061 11/01/2001 GA 4.0 4 F 10/29/2001 Post vax the patient developed whelps, swelling and redness across the entire left thigh measuring 34cm in circumference, and the entire right thigh measuring 38.5cm in circumference. The patient was treated with Cefzil and Orapred. Y 10/22/2001 10/23/2001 1 NONE PVT PUB NONE NONE 1
0177062 11/01/2001 AR 0.1 0 .2 F 09/28/2001 The patient began to have a rash, turning to splotchy hives. The patient's mother states the patient may have had slight difficulty breathing. The patient's temperature was 99.5. Y Y 09/25/2001 09/26/2001 1 PUB UNK Zantac and Reglan NONE Reflux disease 1
0177063 11/01/2001 FL 34.0 34 M 10/24/2001 On 10/23/2001 the patient complained of dizziness and nausea approximately 20 minutes post vax until the patient retired for the evening. Y 10/23/2001 10/23/2001 0 NONE PVT PVT Fiorinal NONE NONE 1
0177064 11/01/2001 TX 30.0 30 F 10/26/2001 Post vax the patient's face was flushed and she had severe stomach cramps. The patient was treated with Benadryl and Phenegran. Y Y 10/23/2001 10/23/2001 0 Blood test and blood gas test. PVT PUB NONE NONE allergy to demeral 1
0177065 11/01/2001 PA 1.0 1 .0 M 10/15/2001 The patient developed 20 pox lesions on various body parts. The patient was afebrile. Follow up on 12/14/2001: "Transferred from our practice to another practice." Y 06/14/1996 NONE PVT PVT 1
0177067 11/01/2001 CA 21.0 21 M 08/01/2001 Post vax the patient experienced localized swelling and itching of the left triceps area. Y 07/30/2001 07/31/2001 1 NONE MIL MIL NONE NONE NONE 1
0177068 11/01/2001 NY 0.4 0 .4 M 10/25/2001 Acute onset of urticarial rash and eye swelling about 30-45 minutes, post vax. Pt was seen by another physician and given Epinephrine, SC. Y Y 09/19/2001 09/19/2001 0 Pt sent to pediatric allergist and skin test was (+) to both vaccines. PVT OTH NONE NONE Milk protein allergy 1
0177069 11/01/2001 CA 1.7 1 .7 M 10/18/2001 Forty eight hours post vax given on left outer thigh, mother noticed erythema with induration from middle of thigh extending medially to approximately the knee, not including the injection site. Y U 10/15/2001 10/17/2001 2 NONE PVT PUB Croup, questionable reactive airway disease 1
0177070 11/01/2001 NV 41.0 41 F 10/22/2001 The pt developed wheezes and crackles in lungs. There was a large warm and edematous area on her left deltoid about 3". She complained of a headache. She was treated with Benadryl 50mg, IM, and Alupent 0.3cc in NS 3cc RT treatment was given. Y Y 10/22/2001 10/22/2001 0 PVT PVT Buspar; Flovent; Trazadone; Depakote; Premarin; Synthroid; Glucophage; Paxil; Geoden; Artane; Maxalt; Alupent NONE Allergy to penicillin, albuterol, Vicodin, Keflex, Vibramycin, Iodine; History of panic disorder; Seizure disorder; DM Type II and psychosis 1
0177071 11/01/2001 NJ 4.0 4 M 07/10/2001 Pt developed a fever to 104 and vomiting x 3 approximately 12 hours post vax. Y 07/09/2001 07/09/2001 0 NONE PVT PVT NONE NONE 1
0177072 11/01/2001 NY 1.25 1 .3 F 09/24/2001 Pt developed fever. U 09/12/2001 09/24/2001 12 PUB PUB NONE NONE 1
0177073 11/01/2001 NY 5.0 5 F 09/24/2001 Pt developed reddened area on thighs and hips, huge hives on right arm, stomach and back. He also had a fever. U 09/12/2001 09/23/2001 11 PUB PUB NONE 1
0177074 11/01/2001 NY 4.0 3 F 09/24/2001 On 08/29/2001 the patient's mother noted red bumps "mosquito bite appearance" around the injection site, quarter to half dollar size. The patient had 2-3 blotches above the site. Three days later the patient had a small spot below the site. The patient was treated with Benadryl for the itching. On 09/15/2001 the patient broke out with 10 spots on her back, more vesicle looking, not clear fluid, white inside. The patient had a few spots on her belly, legs, and shoulder. 09/19/2001 the areas dried up. Y 08/21/2001 08/29/2001 8 NONE PUB PUB Cromolyn and Albuterol nebulizer NONE Premature birth 1
0177075 11/01/2001 MI 1.3 1 .3 M 10/24/2001 The patient's leg became very swollen and red approximately 24 hours following the vaccination. The patient was treated with steroids. Y Y 09/11/2001 09/12/2001 1 NONE PUB PUB Tylenol NONE NONE 1
0177076 11/01/2001 TN 32.0 32 F 10/23/2001 The patient developed erythema and tenderness of the left upper arm on 10/17. On 10/18 the patient developed one maculopapular rash on the forehead. Y Y 10/04/2001 10/16/2001 12 OTH PVT NONE NONE Allergy to iodine 1
0177077 11/01/2001 WA 66.0 66 M 10/15/2001 The patient's arm was sore and swollen four hours after the vaccination and continued the next day. The patient was treated with ice, benadryl and an anti-inflammatory. Y 10/04/2001 10/04/2001 0 NONE PVT UNK NONE NONE Diabetes Mellitus 1
0177078 11/01/2001 WA 71.0 71 F 10/15/2001 On 10/10/2001 the patient was seen for redness, swelling and soreness of the left arm at the site of the injection down to the elbow. Y 10/08/2001 10/08/2001 0 NONE PVT UNK Lisinopril, Metformin and Zantac NONE Diabetes Mellitus, hypertension and GERD 1
0177079 11/01/2001 IN 0.99 0 1 F 10/25/2001 Post vax the patient broke out in chicken pox. Y Y 05/23/1997 10/20/2001 1611 OTH OTH UNK NONE 1
0177080 11/01/2001 OH 1 .0 F 10/27/2001 10/18/2001 the patient developed a significant varicella outbreak, greater than 20 pox. Y 08/21/2000 10/18/2001 423 NONE PVT OTH UNK NONE NONE 1
0177081 11/01/2001 NC 0.75 0 .8 M 10/23/2001 The patient experienced a pink rash over his whole body. Y 10/22/2001 10/23/2001 1 PVT PUB NONE NONE 1
0177082 11/01/2001 MA 1.0 1 .5 F Induration and erythema 2.5 by 2 inches, concomitant Otitis Media. Y Y 10/16/2001 10/18/2001 2 PVT PUB NONE Lactose intolerant/reactive airway disorder. 1
0177083 11/01/2001 WA 31.0 31 F 10/16/2001 On 10/12/2001 at 10 pm the patient noticed the injection site was swollen and painful. On 10/13/2001 the swelling and pain increased. The patient was treated with Benadryl and the symptoms resolved on 10/16/2001. Y Y 10/11/2001 10/12/2001 1 NONE PVT PVT NONE NONE Functional heart murmur 1
0177084 11/01/2001 OR 54.0 53 F 10/23/2001 Pt developed right brachial neuritis due to tetanus toxoid. Rx'd physical therapy and neurological consultation. Y N 05/20/2001 05/23/2001 3 PVT PVT Ibuprofen; Sulfa medication Sinus infection Sinus infection 1
0177085 11/01/2001 OH 62.0 61 F The patient experienced pain at the injection site post vax. Y N 10/25/2000 10/25/2000 0 PVT PVT Hypothyroidism Allergic to penicillin 1
0177086 11/01/2001 VA 7.0 1 .4 M 10/25/2001 The patient developed chicken pox on 10/24/2001. Y Y 05/31/1995 10/24/2001 2338 PVT PVT NONE Left serous otitis NONE Rash~Measles + Mumps + Rubella (MMR II)~1~1.00~In Patient 1
0177087 11/01/2001 VT 0.5 0 .5 F 10/18/2001 The patient experienced a febrile seizure within 24 hours of immunizations. Y 09/25/2001 09/26/2001 1 EEG normal PVT PVT NONE NONE Foot birth defect 1
0177088 11/01/2001 MA 6.0 3 M 10/24/2001 The patient was vaccinated with Varivax 08/05/1998. The patient developed chicken pox 10/24/2001. U 08/05/1998 10/24/2001 1176 PVT PVT NONE NONE 1
0177089 11/01/2001 OH 72.0 73 F 10/25/2001 Post vax the patient experienced arm pain, swelling and redness with localized cellulitis. The patient was treated with Keflex and cool compresses. Y 10/03/2001 10/05/2001 2 NONE PVT PVT Singulair, Volmax, Theo-dur, Prinivil, Lasix NONE Asthma, arthritis, diverticulosis 1
0177090 11/01/2001 MA 0.4 0 .4 M 10/25/2001 The patient "lost head control", stopped rolling over and became listless for 1 1/2 weeks. 09/27/2001 09/27/2001 0 NONE PVT PVT NONE NONE NONE 1
0177091 11/01/2001 AK 4.0 2 .1 F 10/24/2001 The patient was vaccinated with varicella on 02/24/1999 and developed chicken pox with several lesions on 10/16/2001. Y Y 02/24/1999 10/16/2001 965 PUB PUB NONE NONE NONE AK200165 1
0177092 11/01/2001 IN 3.0 3 F 10/18/2001 The patient's left buttock was red and swollen from 09/18 thru 09/20. The patient was treated with Augmentin, Benadryl and ice compresses. The patient was completely recovered by 09/24/2001. Y 09/18/2001 09/18/2001 0 PVT PVT NONE NONE 1
0177093 11/01/2001 MI 1.7 0 .3 M 10/23/2001 One hour post vax the patient experienced a tonic-clonic seizure for two minutes. The patient continued to have seizures and was treated with phenobarbital for one year. Y Y 05/11/2000 05/11/2000 0 EEG, CT, LP all WNL PVT PVT Congested Sickle cell trait 1
0177094 11/01/2001 FL 2.0 1 .5 M 10/22/2001 The patient broke out with shingles on his left thigh where his chicken pox vaccination was given. The patient experienced blisters, pain and itching constantly. The blisters went away in 2 weeks but the pain never goes away. Y Y 08/23/2000 09/29/2001 402 PVT UNK NONE Allergy to Amoxil 1
0177095 11/01/2001 HI 1.0 1 .0 F 10/23/2001 The patient developed a diffuse morbilliform rash and a fever of 100-102.6 nine days after receiving the vaccination. Y 10/10/2001 10/19/2001 9 NONE PVT PVT NONE NONE NONE 1
0177096 11/01/2001 MT 27.0 27 F 08/22/2001 On 07/26/2001 the patient developed shortness of breath, anxiety and heart palpitations. The patient had received her HBV earlier, at 4:00 pm. The patient was wheezing and had a dry non-productive cough. The patient had acute airway spasms. The patient was treated with Albuterol aerosol, Pulmicort and Benadryl. On 07/27/2001 the patient was seen again with mild laryngeal edema in addition to the previous symptoms. The patient was treated with Prednisone and Zyrtec. On 08/03/2001 the patient was seen in the ER for postnasal drip and brochospasm with probable allergic rhinitis. On 08/22/2001 the patient reported chest discomfort after eating. Y Y 07/26/2001 07/26/2001 0 PUB UNK Allegra and Triphasil 1
0177097 11/01/2001 MI 11.0 10 F 10/18/2001 After the first dose, the patient experienced lethargy, a low grade fever and a change in personality. After the second dose, the patient was immediately not feeling good and had difficulty breathing. Y 10/03/2001 10/03/2001 0 NONE PVT UNK NONE Allergies and asthma 1
0177098 11/01/2001 OH 47.0 47 F 10/24/2001 Pt's right arm became swollen to elbow, 3.5" greater than left arm, from vax given 10/22/01. Temperature was 99.2. Pt had redness near elbow. Doctor ordered Medrol dose pack and swelling was down on 10/24/01. Y 10/22/2001 10/22/2001 0 PUB PVT UNK NONE Asthma 1
0177099 11/01/2001 MI 4.0 2 .7 F 10/23/2001 The patient broke out with chicken pox six days after receiving the vaccination. The mother states the patient had both internal and external lesions. The mothers states the patient was "covered" with lesions. Y 01/07/2000 01/13/2000 6 PUB PUB NONE NONE Lactose Intolerance 1
0177100 11/01/2001 ME 68.0 68 M The patient experienced painful swelling at the site of vaccination. Y Y 10/19/2001 10/20/2001 1 NONE PVT PVT Asthma 1
0177101 11/01/2001 TX 11.0 11 F 10/23/2001 On 10/16 the patient's mother reported the patient had a facial rash. The patient was treated with Benadryl. The rash was spreading and the patient had a sore throat and stuffy nose on 10/17. The patient was seen at the ER and treated with antibiotics and diagnosed with a throat infection. The patient's mother called on 10/19 and advised the took the patient to the Dr a couple of times and he thinks the patient may have a reaction to the vaccine. The patient was treated with steroids. Y Y 10/15/2001 10/16/2001 1 PUB PUB NONE NONE 1
0177102 11/01/2001 MN 1.0 1 .0 M 10/22/2001 Pt developed a rash (little pink bumps) on cheeks, arms and legs for about a week. This could have also been a reaction from amoxicillin which pt was taking at the time. Y Y 09/19/2001 09/22/2001 3 PVT OTH Amoxicillin Common cold, ear infection 1
0177103 11/01/2001 OH 1.25 1 .3 M 10/25/2001 Per patient's father the patient has a swollen arm where the shots were given. The area was warm and hard to the touch. The patient has redness at the injection site with purulent drainage. The patient was treated with Tylenol and damp cool cloths. U 10/23/2001 10/24/2001 1 PUB PUB NONE 1
0177104 11/01/2001 MI 0.6 0 .6 F 10/23/2001 Post vax the patient developed a fever of 105F. The patient was treated with Motrin and Tylenol. Y U 10/19/2001 10/20/2001 1 NONE PVT PUB NONE Neurofibromatosis 1
0177105 11/01/2001 IL 4.0 4 F 10/23/2001 Nine days post vax, the patient broke out with a maculopapular erythematous rash on her entire body. The patient was diagnosed with measles. Y Y 05/29/2001 06/07/2001 9 Rubeeola IgMAB = Negative PVT OTH NONE Fever and sore throat NONE 1
0177106 11/01/2001 WI 1.25 1 .2 F 10/24/2001 Febrile seizure 8 days after receiving MMR and HIB vaccines. Y Y 04/27/2001 05/05/2001 8 CxR- LLL pneumonia, glu 112, Bun 16, creat 0.4, co2 21.2, wbc 5.0, Hgb 12.8, lytes nl PVT PVT NONE NONE NONE 1
0177107 11/01/2001 OH 70.0 70 F 10/25/2001 Pain L deltoid, anti - inflammatories, ice, darvocet N-100 prn break through pain. Y 10/03/2001 10/05/2001 2 NONE PVT PVT NONE NONE Rheumatic heart disease 1
0177108 11/01/2001 OH 5.0 5 F 10/26/2001 Pt rec'd DTaP in the R deltoid on 10/23/01. she presented in our office on 10/25/2001 with a cellulitis at the injection site. she is being treated with Keflex 250mg/ 5ml 1 1/2 tsp po QID times 7 days. Y U 10/23/2001 10/25/2001 2 PVT PVT Zyrtec po Allergic rhinitis 1
0177109 11/01/2001 IN 5.0 5 M 10/24/2001 10/24/01 8am - day following immunization, pt woke up with right arm swollen for shoulder to elbow. Slight redness at the site of injection. Saw physician on 10/24/01. Y Y 10/23/2001 10/24/2001 1 NONE PUB PVT NONE 1
0177110 11/01/2001 NJ 86.0 86 F 10/23/2001 Itching, swelling, pain on 10/17/01 (Benadryl given) red and tender to the touch 10/18/01, Keflex given on 10/18/2001 - 10/24/2001. Y Y 10/17/2001 10/17/2001 0 PUB PUB Vasotec for high blood pressure NONE Slight dizziness off and on 1
0177111 11/01/2001 FL 9.0 9 M 10/20/2001 Had hives within 4 hrs after receiving varicella vaccine. rec'd benadryl and the hives gradually disappeared next day. Y 10/01/2001 PVT PUB 1
0177112 11/01/2001 NJ 4.0 4 F 10/24/2001 Redness & swelling of L arm form shoulder to elbow since 10/23/01, decreased swelling today as per mom. Cool compresses & ibuprofen. U 10/22/2001 10/23/2001 1 PVT PVT NONE 1
0177113 11/01/2001 NE 57.0 57 F 10/23/2001 Local redness & swelling about 10cm Y 10/18/2001 10/20/2001 2 PVT PVT NKA 1
0177114 11/01/2001 OH 5.0 5 F 10/15/2001 Cellulitis at immunization site Y 10/03/2001 10/13/2001 10 MIL UNK PPD/ Adventis/C0833AA/LA/0 Diatin, vantin, ceftn 1
0177115 11/01/2001 NC 1.75 1 .7 F 10/24/2001 Pt was inadvertently given adult Td (0.25ml) rather than a ? vaccine. Broke out in hives at 11am 10/23/01.malaise - mild - afebrile R thigh swollen & red started 10/23/01pm. Y 10/22/2001 10/23/2001 1 PVT PUB Albuterol - via nebulizer, Zyrtec, pulmicort NA recent hospitalization for asthma. 1
0177116 11/01/2001 CA 21.0 21 F 09/28/2001 9/25/01 rec'd TD in R delt & MMR in L delt. 9/28/01 R shoulder is red, swollen, painful a little bit of rash, hot, itchy. 09/25/2001 09/26/2001 1 PUB PVT NONE NONE NONE 1
0177117 11/02/2001 KY 0.08 0 .1 F 10/31/2001 SIDS death Y 10/21/2001 N 09/24/2001 PUB PUB NONE NONE NONE KY2001081 1
0177119 11/02/2001 4.0 4 M 10/21/2001 On 10/16/01, the pt's parent reported a severe cellulitis on their son's arm, located below the deltoid and above the elbow, at the site of the injection. The pt was seen by a physician on 10/17/01 when the cellulitis area was determined to be approx. 11.5cm by 12.5cm in size. The event was considered to be "Medically Significant". The physician prescribed oral onphalexin antibiotic to treat the cellulitis. The event was still ongoing at the time of reporting. The reporter has assessed the relationship of study medication to the event as probable. N 10/15/2001 10/16/2001 1 UNK UNK Zantac; Albuterol; Intal PJP2001003420 1
0177120 11/02/2001 NY 1.8 1 .9 M 10/31/2001 Pt developed a fever and seizure. This child was admitted. It seems that seizure associated with febrile episodes was related to vaccination. Y Y Y 10/22/2001 10/22/2001 0 ESR; Blood cultures-no infectious source was found OTH OTH UNK NONE NONE 1
0177121 11/02/2001 MI 0.4 0 .4 M 10/30/2001 After 4 days, post vax, the pt developed poor sucking lasting for 24 to 36 hours. No fever, irritability or lethargy. After 1st set of immunizations, he had a similar history at the 2nd day and got dehydrated and was given IVF; was thought to be viral in etiology at that time. Y 10/23/2001 10/25/2001 2 Normal PVT PVT NONE NONE Congenital bilateral hydronephrosis (under evaluation) 1
0177122 11/02/2001 AR 10.0 10 M 10/22/2001 Post vax the patient developed a 3-4cm red induration at the injection site with a small patchy area of pruritic rash. Treated with Ibuprofen and Cortisone. Patient to call clinic if worsens. Y 10/19/2001 10/21/2001 2 NONE PVT PVT Asthma 1
0177123 11/02/2001 ME 40.0 40 F 11/11/2001 Post vax the patient reported "heart pounding" in her chest and difficulty taking a breath. The patient was treated with epininephrine. Call 911 and transferred patient to emergency dept. Y Y 10/30/2001 10/30/2001 0 NONE OTH OTH NONE ME01039 1
0177124 11/02/2001 ME 48.0 48 F 11/01/2001 Post vax, the patient developed a rash, hives on her back and neck, and lip swelling. The patient refused treatment. The symptoms started resolving within 45 minutes. Y 10/31/2001 10/31/2001 0 NONE OTH OTH NONE PCN, Thimersil sensitivity ME01038 1
0177126 11/02/2001 NY 56.0 56 F 10/30/2001 The patient started a dry cough with yellowish phlegm on 10/20/2001. Treated with Guaifenex LA. Y Y 10/19/2001 10/20/2001 1 NONE OTH PVT Glyset, Synthroid, Enapril, Avandia, Coreg, Glucovane NONE 1
0177127 11/02/2001 VA 58.0 58 F 10/31/2001 The patient had chills and dizziness. The patient's arm was red and hot with fever. The patient could not raise her arm for 2 days. The patient slept all day Saturday and Sunday and was sore on Monday from laying around. It is now Wednesday and my arm is still red, hurts and has a fever. N 10/26/2001 10/27/2001 1 OTH OTH Celebrex, Singulair, Premarin, Accupril, Medroxyprogesterone NONE 1
0177128 11/02/2001 CO 39.0 39 F 10/17/2001 Post vax the patient developed a painful area of redness and slight induration over the injection site about 8cm in diameter. The patient complained of a flare up of carpal tunnel syndrome with wrist and forearm pain, and paresthesis in the first 3 fingers. Y U 10/15/2001 10/16/2001 1 MIL MIL OCP's, Serevent, Beclovent, Proventil Asthma, Carpal Tunnel Syndrome 1
0177129 11/02/2001 NY 24.0 24 F 10/23/2001 Post vax, the patient developed tingling in her fingers and numbness, swelling and pain of arm. Y 10/18/2001 10/18/2001 0 UNK PUB 1
0177130 11/02/2001 MD 66.0 66 M 10/30/2001 After receiving 2 vaccines on the same day, the patient developed a local reaction at the pneumovax site with bilateral hand swelling and a fever of 101F. The patient still has these symptoms. N 10/25/2001 10/25/2001 0 PVT PVT Colchicine, Allopurinol, Visteral, Zestril, Cardura NONE Allergy to penicillin 1
0177131 11/02/2001 WI 55.0 55 M 10/23/2001 Two hours post vax, developed angioedema of the upper lip. Progressed despite treatment with Benadryl. ER treated with epinephrine, IV Benadryl, and prednisone. Y Y 10/22/2001 10/22/2001 0 PVT PVT Linsinopril, glucophage, lopid, lipitor, thiazide, glynase NONE NONE 1
0177133 11/02/2001 MI 1.3 1 .0 F 10/23/2001 High fever and maculopapular skin rash that erupted between 7 and 10 days after Prevnar injections. 1st and 2nd dose-exact same reaction. Y 06/24/2001 06/30/2001 6 NONE PUB PUB NONE NONE NONE fever,rash~Pneumo (Prevnar)~3~0.70~In Patient 1
0177134 11/02/2001 NJ 1.4 1 .4 F 10/10/2001 Fever of 101-103 developed 10 days after immunizations while a generalized rash developed 1 day later. Pt seen 2 days later at office on 10/6/01. PE positive for generalized maculo-papular rash on thorax, few on extremities. Positive petechie upper palate. History of subsequent desquamation. Tylenol rx'd for fever. Y Y 09/24/2001 10/04/2001 10 PVT PVT NONE NONE 1
0177135 11/02/2001 CT 64.0 63 F 10/20/2001 Received Lymevax after being treated for Lyme a year before- became very fl-like-strong pain-muscles and joints. Nothing relieved till pt had and IV treatment.Pt still being treated /tested U 05/01/2000 05/01/2000 0 General complete Lyme test for several years and spinal tap that was positive. PVT PVT cholesterol, HBP, and depression Cholesterol, HBP,depression 1
0177136 11/02/2001 NJ 43.0 43 M 10/29/2001 After shots flu like symptoms, night sweats, and fever, swelling of legs and lower joints( foot, ankle,andknees) over 2 yrs have passed since shots and still having join pains and swelling. Y N 06/28/2001 07/28/2001 30 All blood work normal, still testing. PVT PVT NONE 1
0177137 11/02/2001 TX 29.0 28 F 11/01/2001 On 10/31/01 soreness in arm and neck, with pain on movement. Also had swelling. Took Ibuprofen because nauseous. On 11/1 symptoms abating. N 10/30/2001 10/31/2001 1 PUB PUB Zoloft, OTC cough syrup,and ortho novum NONE Chronic cough, nose bleeds 1
0177138 11/02/2001 KY 1.0 1 .0 F 10/22/2001 Mother states child developed low grade temperature on 10/12/01 and on 10/19/01 temperature was 105 degrees. Began developing rash on neck, chest, back, buttocks and arms on 10/22/01. Mother stated it looks like heat rash but I know its not. Y 10/16/2001 10/18/2001 2 PUB PUB NONE KY2001080 1
0177139 11/02/2001 NY 12.0 12 F 10/04/2001 Pt fainted after receiving 4 vaccines. She became alert 10-15 seconds later. Y 09/04/2001 09/04/2001 0 PUB PUB 1
0177140 11/02/2001 NY 14.0 14 F 10/04/2001 Tight chest, mild wheezing, puffy face, red eyes, sneezing, and itchy throat. Y 09/05/2001 09/05/2001 0 UNK UNK 1
0177141 11/02/2001 ME 1.7 1 .7 F 10/31/2001 Swelling golf ball size, fever reached 102 F, nausea, vomiting and diarrhea. Y Y 10/15/2001 10/15/2001 0 PVT PUB NONE NONE NONE ME01038 1
0177142 11/02/2001 CA 1.4 3 M For 3 days pt had itching, scattered rash varicella like, and lymphdemopathy. Y 09/27/2001 10/15/2001 18 NONE PUB PUB NONE NONE 1
0177143 11/02/2001 MO 8.0 13 M 10/23/2001 Failed chicken pox vaccine. Around 50 chicken pox lesions. Y 08/21/1996 10/19/2001 1885 NONE PVT PVT NONE NONE 1
0177144 11/02/2001 VT 67.0 67 F 10/20/2001 pt has swelling, redness and pain. 5 cm developing at site of injection right upper arm. Y N 10/18/2001 10/18/2001 0 NONE PVT OTH HRT NONE NONE 1
0177145 11/02/2001 NJ 4.0 4 M Fever, warm, hot indurated, red 95X105 mm. PO ABX for cellulitis. Y 10/22/2001 10/22/2001 0 PVT PVT Seasonal allergies 1
0177146 11/02/2001 ME 4.0 4 F 10/25/2001 Noticed on 10/24/2001 injection hot to touch and red and swollen. Area of redness 2 X 3 inches. On 10/25/2001, left upper arm with 805 X 7.0 cm with erythema and mild swelling, induration, warm-non tender. Instructed cool compresses and Benadryl. Lidocaine topical prn. Y Y 10/23/2001 10/24/2001 1 PVT OTH cold symptoms-runny nose NONE 1
0177147 11/02/2001 TX 68.0 68 F 10/29/2001 Nausea-stomach upset, with inclination to vomit-very severe diarrhea for a week. I took Promethazine for nausea, Imodium AD for one week until the nausea and diarrhea stopped. Y Y 10/03/2001 10/04/2001 1 PUB PVT NONE 1
0177148 11/02/2001 SC F chills, weak, dyspnea, papular rash and temperature of 102. Y U 10/22/2001 10/24/2001 2 PVT PVT Verapamil, premarin, maxide, provera NONE Asthma 1
0177149 11/02/2001 AL 7.0 7 F 10/26/2001 Within 15-20 minutes after vaccination in left upper forearm, pt had urticarial rash on forearms, spreading to face and trunk, no respiratory sx, resolved with oral Benadryl and observation. Y 10/26/2001 10/26/2001 0 NONE PUB OTH Nasal congestion and sinnusitis NONE 1
0177150 11/02/2001 IN 39.0 39 F 10/26/2001 One month following vax, pt's ALT (SGPT) was 169 and AST (SGOT) was 70. Pt had no symptoms. The abnormal labs were noted through routine bloodwork. U 09/18/2001 10/17/2001 29 All follow-up labs-nml PVT PVT NONE NONE 1
0177152 11/05/2001 FL 1.2 1 .0 M 10/26/2001 Pt developed Herpes Zoster-facial and LUQ. No ocular or otic involvement. Treated with IV nafcillin and acyclovir. Discharged home on oral acyclovir. Y Y 3 Y 07/30/2001 10/20/2001 82 PVT PUB NONE NONE NONE 1
0177153 11/05/2001 NM 59.0 59 M 10/28/2001 Around 11:30 on 10/2/01, he called his son and said he was dizzy and nauseated and was brought to MD's office with erythema, confusion and lethargy. His BP was 54/40, then 74/30. He was given epinephrine, SC, steroids and IV fluids in ER with full recovery. He also had taken 1 aspirin at 10:00. He is not allergic to eggs. He had taken flu vaccine on 1/11/01 without problem and previous aspirin also. Y Y Y 10/02/2001 10/02/2001 0 PVT PVT ASA NONE High BP; ASHD; Hypothyroidism 1
0177155 11/05/2001 OH 14.0 14 M 10/09/2001 Guillain-Barre Syndrome developed about 1 month, post vax. Still with symptoms. Per doc 215039, patient is still "ill" wearing braces + been to hospital several times. Per 1 year follow up: It is unknown if pt has recovered. Any residual symtoms have been updates and sent to CDC 01/03/2003 Y 1 N 08/08/2001 09/04/2001 27 Nerve conduction studies PVT PVT NONE ADHD OH0056 1
0177156 11/05/2001 NM 0.25 0 .3 F 10/28/2001 Pt developed 2 brief seizures and a low-grade fever. Both self resolved. Seizures occurred about 20 hours, post vax. Y Y Y 10/18/2001 10/19/2001 1 Head CT-neg; SMA-7; CBC; BC PVT OTH Tylenol Mild URI NONE 1
0177157 11/05/2001 NH 0.4 0 .4 F 10/29/2001 The child was taken to ER for projectile vomiting X 3 on 9/9/01. During the exam, the pt stopped crying, eyes glazed over for 5 seconds and had decreased responsiveness. No apnea, color change or desaturations. Heart rate changed from 140 to 90. Pt then resumed normal activity. She was observed overnight and discharged home. No further seizures noted. Vomited 1 X in hospital (small amount of yellow fluid). Y Y 1 Y 09/07/2001 09/09/2001 2 Pulse Ox 100%; CBC-WBC 19.1, platelets over 40, segs 36, bicarbs 16, chemistries-nml OTH PUB NONE NONE Gastroenteritis/Colitis, allergic dx'd after hospitalization NH0122 1
0177158 11/05/2001 NC 0.2 0 .2 F 11/02/2001 The evening, post vax, pt reported to ER with vomiting, hemocult (+) diarrhea and dehydration. Pt received 4 bolus of NS, bicarb and admitted for workup (blood and urine cultures-neg). Placed on ?. Y Y Y 4 Y 10/26/2001 10/26/2001 0 Blood culture, urine culture-neg PVT OTH NONE NONE 1
0177159 11/05/2001 MA 37.0 37 F 11/02/2001 Vaccine given at approximately 10:45am. Symptoms of tingling accompanied by brief sharp pain (1-2 seconds duration) occurred intermittently within twenty minutes of injection. This has repeated 6 - 7 times until now (3pm). Pain and tingling occurs left lower pelvic region and starts to radiate to left upper thigh. U 11/02/2001 11/02/2001 0 OTH OTH NONE 1
0177160 11/05/2001 CA 44.0 44 F 11/01/2001 70cmx60cm red area (knot) on upper arm, warm to touch, developed about 48 hours after administration of vaccine. Treatment ice and Ibuprofen. Reported to Occupational Health Nurse. Y 10/30/2001 11/01/2001 2 NONE PUB PVT NONE Pt had allergic reaction to Thimersal in contact lens solution about 20 years ago. Seasonal allergies, takes Claritin. 1
0177161 11/05/2001 TX 69 M 10/26/2001 Flu had to get treatment from doctor. Y N 10/11/2001 10/14/2001 3 PUB PVT NONE Emphysema 1
0177162 11/05/2001 IL 62.0 62 F 10/30/2001 Rash to upper extremities and neck. Pt not on any other meds. Y 10/04/2001 10/05/2001 1 NONE PUB UNK Avapro and questionable Allergy Shots NONE NONE 1
0177163 11/05/2001 TX 68.0 68 F 10/26/2001 Flu had to go to ER for treatment. Got ill 3 days after receiving shot, I am still sick. Y N 10/11/2001 10/14/2001 3 PUB PVT NONE 1
0177164 11/05/2001 OK 0.25 0 .8 F 10/29/2001 Diffuse erthymatic, rash from head to toe. Large egg size knot on right thigh. Y U 10/24/2001 10/25/2001 1 OTH OTH Dermatitis 1
0177165 11/05/2001 IL 1.3 1 .3 M 10/25/2001 Hives 1 cm 5 minutes after vaccine and redness around about 5 cm diameter. Benadryl 12.5 mg PO given. Y 10/25/2001 10/25/2001 0 NONE PUB PUB NONE NONE NONE 1
0177166 11/05/2001 FL 0.3 0 .3 M 10/26/2001 Immediately following HiB injection to RAT; thigh swelled, hot to touch and red. Cool moist compress applied. Pt held in office. Thirty-five minutes later swelling down and redness decreased. Pt release with instruction to continue cool compresses. Mom to phone office if any change. Y 10/26/2001 10/26/2001 0 PVT PVT 1
0177167 11/05/2001 IN 1.13 1 .1 F 10/29/2001 Decreased appetite, nasal drainage, overall rash (except legs), high fever (started 10/17/2001) and constipated. Seen by Dr. 10/25/2001 and 10/28/2001. Y Y 10/16/2001 10/16/2001 0 NONE PUB PVT NONE NONE 1
0177168 11/05/2001 NJ 46.0 43 M 10/29/2001 Pains in my left upper leg, my right foot, swelling of right index finger and back pain. Y N 05/03/1999 X-Ray and MRI Hillsboro Radiology PVT OTH 1
0177169 11/05/2001 ME 5.0 5 M 10/22/2001 Pt developed red, itchy rash on and off at injection site. Per mother, the rash goes away and then comes back 1-2 wks later. Initially there was a red spot which lasted x 1 month after immunization. It went away and then a small red spot came back and spread 2 wks later. U 08/01/2001 08/02/2001 1 NONE PVT PUB NONE NONE Autism, hyperactivity, oral aversions 1
0177170 11/05/2001 PA 51.0 51 F 10/01/2001 Pt developed moderate pain at injection site that woke her up 1-2 times during the night. She had difficulty raising her arm because of soreness. There was erythema about the size of a 50 cent piece, and it was warm to touch. The pain finally resolved 10/22/01. Y 10/05/2001 10/05/2001 0 PVT PVT Atenolol, Lanoxin, Premarin, Norvasc, ASA, Tricor Increased triglycerides, CAD s/p stent placement 1
0177171 11/05/2001 CT 0.2 0 .2 F 10/31/2001 Pt developed excessive screaming for 48 hours following vax. Y Y 10/26/2001 10/26/2001 0 NONE PVT PUB NONE NONE 1
0177172 11/05/2001 IN 0.5 0 .2 F 10/29/2001 Pt developed screaming post vax. Her right leg became swollen and red. Mother thought pt had labored breathing as well. Y Y 06/13/2001 06/13/2001 0 PVT PVT NONE NONE NONE Screaming, swelling & redness of leg, labored breathing~DTaP (no brand name)~1~0.20~In Patient 1
0177173 11/05/2001 NH 0.75 0 .8 M 10/29/2001 10/27/2001 Parents seen with child at clinic. Parent report child had temp of 105 and seizure last night. Was taken to ER. No report avaiable. Seizure related to immunizations of viral illness. Y Y 10/25/2001 10/27/2001 2 PVT PUB NONE NONE Paternal History of febrile seizures 1
0177174 11/05/2001 CA 1.0 1 .1 F 10/29/2001 Pt developed a fever of 102 for 2 days which resolved. She developed vesicles in her mouth and on her lips, a couple of which have become pustules. She refuses to drink or eat secondary to the discomfort. Y U 10/25/2001 10/25/2001 0 Viral culture of pustule pending PVT PVT NONE NONE NONE 1
0177175 11/05/2001 VA 5.0 1 .7 F 10/29/2001 Mild case of varicella with skin and oral lesions 10/24/2001. Y 09/10/1997 10/24/2001 1505 PUB OTH NONE Asthma 1
0177176 11/05/2001 WI 2.0 2 .5 M 10/25/2001 Developed large amount of soft tissue swelling with surrounding erythema within minutes of injection. Central portion of swelling looked bruised. Treatment was Benadryl po, ice pack and observation. Y 10/24/2001 10/24/2001 0 NONE PUB PVT NONE Otitis Media NONE 1
0177177 11/05/2001 WI 11.0 11 M 10/25/2001 Upper left arm swollen (noticible) red (size 16cm long by 8cm wide), warm to touch. Applied ice and within 30 minutes arm felt much better. Benadryl 2tsp at 6pm. Resolved within 12 hours. Mom reports younger sister hitting brother in area of shot. Afebrile. Y 10/22/2001 10/23/2001 1 OTH PUB NONE NONE NONE 1
0177178 11/05/2001 NY 3.0 3 M 10/29/2001 Pt developed a rash and tactile fever. U 10/23/2001 10/25/2001 2 PVT OTH NONE NONE NONE 1
0177179 11/05/2001 OH 25.0 25 M 10/04/2001 Received hep B vaccine. Onset 30 minutes after injection, dizziness, nausea, face flushed and slight increase BP, decreased pulse. Checked by school nurse then ER physician. No Rx. S and S resolved. Diagnosis are adverse reaction by ER physician. Y Y 10/03/2001 10/03/2001 0 NONE OTH PVT NONE NONE NONE 1
0177180 11/05/2001 NC 1.3 1 .3 F 10/29/2001 Pt developed a generalized rash with fine, flat papules. Y Y 09/28/2001 10/07/2001 9 NONE PVT OTH NONE NONE 1
0177181 11/05/2001 MA 10 F 10/26/2001 The night of receiving vax, pt developed erythema and swelling at injection site. The following day, pt had fever and induration. The swelling subsided slightly with cold compresses. Pt was seen 10/26/01 and treated with oral antibiotics. U 10/22/2001 10/22/2001 0 NONE PUB OTH NONE NONE 1
0177182 11/06/2001 11.0 F 11/02/2001 A consumer reported that her 11 year old daughter received a dose of DTP approx. 10 years ago. That same day, the child developed a fever and experienced convulsions. The child received no treatment for the events. The mother reported that her daughter had become autistic. The convulsions and autism were considered "Medically Important Events". U UNK OTH OTH UNK UNK UNK HQ7930501NOV2001 1
0177183 11/06/2001 NC 0.2 0 .2 M 11/02/2001 A physician reported that a 2 month old male received his 1st dose of Prevnar on 10/26/01. That same day, the infant developed a fever, decreased appetite and became listless. He was hospitalized. F/U states: The reporter stated that the symptoms resolved "about 24 hours later". F/U information received from the physician on 11/28/01, indicated that the infant also displayed a lack of eye contact and was "less interactive". The infant was treated with ampicillin and Rocephin (ceftriaxone). Y Y 10/26/2001 10/26/2001 0 LP-results not reported; F/U on 11/28/01 states: CBC showed WBC-18.5k/ul, hemoglobin of 10.0g/dl; hematocrit-29.8; UA, blood culture, urine culture and CSF were negative. An analysis of CSF showed WBC at 6%, leukcytes at 38% and RBC at 1415/ul; CSF protein and glucose levels were nml and a CXR was neg. PVT OTH NONE NONE UNK HQ7928301NOV2001 1
0177199 11/06/2001 IN 49.0 49 M 10/24/2001 Vastibular neuritis () vertigo. Y 1 Y N 06/21/2001 06/30/2001 9 ENG PUB OTH NONE NONE Vertigo~Hep B (no brand name)~~49.00~In Patient 1
0177200 11/06/2001 VA 10.0 10 F 10/12/2001 Arm swollen from wrist to shoulder. Treated in hospital with IV antibiotics for cellulitis. Y 5 Y 09/26/2001 09/26/2001 0 Blood culture negative OTH PUB Penicillin 250mg bid NONE HbS Beta Zero Thalassemia 1
0177201 11/06/2001 NJ 65.0 61 F 12/06/2002 Severe back and neck pain. Severe pain in several fingers and now also in toes. Went to Chiropractor, Orthopedic and Physical Therapy. The follow up states back and neck pain. Severe pain in several fingers like arthritis. Y N 05/17/1999 10/01/1999 137 OTH OTH NONE NONE 1
0177202 11/06/2001 DE 41.0 41 M 10/29/2001 Soreness at injection site. Lyme symptoms rapidly worsening with neuropathies, central nervous system deficits and autoimmune disease. Recovery is ongoing. Y N 06/01/1999 06/01/1999 0 Serum reactive for B B even though multiple tick bites; mainly symptoms PVT PVT Ritalin Undiagnosed Lyme disease None 1
0177203 11/06/2001 MI 0.2 0 .2 M 11/05/2001 Within 2 days of 2 month immunizations, baby developed poor sucking resulting in decreased intake of fluids and subsequent dehydration. He was hospitalized and treated with IV fluids. At that time, the episode was thought to be of viral etiology but had similar response after 4 month vaccines, not requiring treatment. Y 2 Y 08/17/2001 08/19/2001 2 Labs-nml PVT PVT NONE NONE Congenital bilateral hydronephrosis (under evaluation) 1
0177204 11/06/2001 DE 51.0 51 F 11/02/2001 GBS, onset approx. 10/30/01; currently hospitalized. Ongoing. Per doc 211932, 60 Day follow Up, GBS with rediagnosis of CIDP, also states that patient walks bu still has neuropathies and residuals. The annual follow up states, "Developed CIOP, medically on disability. Last known symptom muscular weakeness although ambulatory." Y N 10/18/2001 10/30/2001 12 Ongoing OTH PVT NONE 1
0177205 11/06/2001 MA 86.0 86 F 10/30/2001 Vomiting, fever, achy, loss of appetite, stomach pain. Given IV's. The discharge summary states weakness, dehydration, vertigo and nausea. Y Y 3 Y 10/26/2001 10/26/2001 0 Stomach X-rays OTH PUB NONE Osteoporosis; "inner ear problem," dementia 1
0177206 11/06/2001 CT 51.0 51 F 10/25/2001 Tingling in legs, increased to shooting nerve pains in legs and also memory loss. Treated with Amoxicillin po X 6-8 weeks; IV antibiotic X 8 weeks. Y N 04/01/1999 04/01/1999 0 Western Blot; Elisa-equivical PVT OTH Joint pain NONE 1
0177208 11/06/2001 SC 70.0 70 M 11/01/2001 At 1pm the left arm was sore. By 7pm it was red and hard shoulder to elbow. Low grade temperature per wife. He drank ice water and passed out. Ambulance summoned. ER visit. Y Y 10/29/2001 10/29/2001 0 Glucose increased 232, UBC increased 160. EKG and chest X-ray normal, cardiac panel, protime, PTT and CBC normal. PUB PVT NONE NONE NONE 1
0177209 11/06/2001 OR 48.0 48 F 10/25/2001 At 1000, pt feeling shaky, "different", feeling like going to fall. At 1050, lips itching, pruretic macular red areas on neck, no SOB. At 1115, scratchy throat. At 1125, scratchiness gone. At 1145, symptoms have ceased. At 1105, Sdrimedrol 125mg IV, Benadryl 25mg IV. Then Prednisone 6 tabs this afternoon, then 5,4,3,2,1. Y Y 10/17/2001 10/17/2001 0 NONE PUB PVT Pevacid 30mg, Premarin, Lamotal 200mg and vitamins. NONE Asthma, GERD, depression, Post menopausal and no allergies. 1
0177210 11/06/2001 NY 37 M 10/26/2001 Client got pneumonia shot on 10/23/2001 and right arm swelled, redness and pain. Y Y 10/23/2001 10/23/2001 0 UNK PVT NONE NONE 1
0177211 11/06/2001 MO 53.0 53 M 10/29/2001 Generalized rash. Y 10/22/2001 10/24/2001 2 OTH PVT NONE NONE NONE 1
0177212 11/06/2001 CA 58.0 58 F 10/02/2001 Swollen arm 15 minutes after administration of vaccine. Bad headaches 4 days, disrupting sleep and work. U 09/28/2001 09/28/2001 0 OTH PVT NONE 1
0177213 11/06/2001 NY 88.0 88 M 10/29/2001 Pt present to clinic with facial swelling, edema and tenderness. Pt states he started with symptoms 1 hour after flu injection. Treatment consisted of tapering doses of Prednisone. Y Y 10/19/2001 10/19/2001 0 PVT PUB MOV, Toprolx L, Lasix, Prinivil, Cooumedin and ASA CHF, Cardiomyopathy, Atnalfib and anemia. 1
0177214 11/06/2001 CA 47.0 0 .1 F 10/24/2001 Swelling, painful, vomited last night, chills, fever and pain under left armpit. Saw MD (states increased stress lately). Y U 10/23/2001 10/23/2001 0 UNK PUB Medq-Myselene (seizures), Procardia (Increased BP). NONE Seizure disorder and hypertension. CA010122 1
0177215 11/06/2001 CA 58.0 68 F 10/25/2001 High fever, joint aches, chills (next day), left arm edema, redness, hot to touch and edema great enough to hide elbow. One week later pt still feels tired. Y 10/18/2001 10/18/2001 0 PUB PUB HCTZ 25mg and potassium supplement. NONE Seasonal allergies, no medical conditions. CA010121 1
0177216 11/06/2001 CA 53.0 53 F 11/01/2001 Employee received flu vaccine on 10/24/2001 at around 10am. She stated when she arrived home she felt pain, redness, swelling and aching all the way down to finger tips (dull ache). She immediately applied ice pack on and off. On 11/02/2001, complained of soreness and pain to touch on RA. Y 10/24/2001 10/24/2001 0 PUB UNK 1
0177217 11/06/2001 WA 51 F 10/26/2001 Pt developed a 12 x 6 cm area of redness, swelling and warmth to touch on left arm. Y U 10/24/2001 10/24/2001 0 OTH PVT Lortab, Zoloft, Premarin NONE NONE 1
0177218 11/06/2001 NJ 41.0 41 F 10/29/2001 Extreme pain in the right arm. She couldn't move her arm for 3 days. Y 10/17/2001 10/17/2001 0 PUB PUB Prevacid, Vitamin E, Miralak, Coace and Claritin. NONE Pemphegoid,Tumor removed from spine recently. 1
0177219 11/06/2001 IL 71.0 71 F 10/26/2001 Rapid heart rate 4.5 to 5 hours after flu vaccine. No treatment. Y 10/02/2001 10/05/2001 3 PVT OTH NONE 1
0177220 11/06/2001 VA 89.0 F Local reaction upper arm (deltoid muscle) area appeared dark red. Was given Tylenol and cold compresses. Y UNK PVT 1
0177221 11/06/2001 LA 31.0 31 F 11/01/2001 Eight hours after Fluzone, was having a disagreement with husband, out of the ordinary, throwing things, banging hands on table, driving away without shoes, some events she did not remember doing. U 10/29/2001 10/29/2001 0 PVT PVT Wellbutrin and Tenormin NONE PMS and HTN 1
0177222 11/06/2001 CA 31.0 31 F 10/30/2001 Pt felt warm feet and numbness of lips and body. Treated with Benadryl only. Y Y 10/27/2001 10/27/2001 0 PVT PVT NONE NONE 1
0177223 11/06/2001 MI 38.0 38 M 10/25/2001 Generalized myalgias, arms, shoulders, legs and elevation of liver enzymes (SGOT and SGPT). Y Y 10/09/2001 10/11/2001 2 SGOT increased to 71 (normal 0-37) and SGPT increased to 47 (normal 0-40). PVT PVT Zestril (Lisimopril) Hypertension (controlled) Hypertension (controlled) 1
0177224 11/06/2001 MO 45.0 45 M 10/31/2001 11/01/2001 Telephone call, continued to have dull headache, back to work. Y 10/26/2001 10/29/2001 3 NONE OTH UNK Avendol, Trezedone and Desipreanine. NONE NONE 1
0177226 11/06/2001 IL 72.0 72 M 10/18/2001 Pt's right upper arm was red, swollen and hot to the touch. Pneumococcal injection given in right deltoid on 10/16/01. Pain in arm started on evening of 10/16/01. Y U 10/16/2001 10/16/2001 0 PUB PUB Toprol 50mg; Celebrex 300mg; Diovan 160mg; indomethacin Allergy to Dawn soap 1
0177227 11/06/2001 IL 69.0 69 F 10/22/2001 Pt received vaccine around 10:30 and at approx. 16:00 that evening, she started feeling achy, possible fever and diarrhea started the following day (10/20/01). Y 10/19/2001 10/19/2001 0 PUB PVT NONE NONE IL01045 1
0177228 11/06/2001 CT 40.0 40 F 10/31/2001 Pt received vaccine on 10/22/01. On 10/25/01 c/o flu like symptoms, cough, hoarseness, SOB upon exertion decreased energy. Afebrile. Monitor S/S, rest. Teacher to F/U with PCO if S/S persist. Y 10/22/2001 10/25/2001 3 N/A OTH OTH N/A N/A 1
0177229 11/06/2001 TX 29.0 29 F 10/30/2001 Rash to injection site painful, edematous area approx. size of half dollar coin. Y 09/22/2001 09/23/2001 1 NONE PVT PVT Singulair 10mg dly NONE Asthma no drug allergies 1
0177230 11/06/2001 CA 26.0 26 F 10/30/2001 Vaccine given 10/23/01. On 10/25/01 F.A noted painful sensations of heat/cold numbness tingling in the left anterior/medial deltoid area. Has had past flu vaccines with reactions. NO local tenderness, erythema, heat or nodularity. U 10/23/2001 10/25/2001 2 PUB PUB Servent, azmacort/allegr NKDA, cats, seasonal pollens, grass, asthma 1
0177231 11/06/2001 GA 44.0 44 F 10/31/2001 Pt c/o hard knot at injection site with slight soreness. No c/o redness or fever. Y 10/29/2001 10/30/2001 1 PUB PVT NONE Sulfa 1
0177232 11/06/2001 WI 19.0 19 F 10/30/2001 1st day golf ball size lump with redness and purple with warmth around area. 2nd day lump grew to soft ball size w/redness, purple and swelling. Felt Warm to touch. 2nd started on Augmentin day 3 lump size going down. Y 10/19/2001 10/20/2001 1 NONE PVT PVT NONE NONE allergy to Biaxin, Crohn's disease 1
0177233 11/06/2001 WA 60.0 60 M 10/31/2001 Within hours of injection R arm sore, by 6 hrs later some what red, mildly, tender. TX - for comfort acetaminophen. Y 10/22/2001 10/22/2001 0 PVT UNK Liver transplant, immunosuppressed cirrhosis, ? (resolved after transplant 6/00) 1
0177234 11/06/2001 WA 42.0 41 F 10/26/2001 Pt stated there is pain since injection and began with a "egg sized" lump at injection site. Continues with pain and R arm is swollen form shoulder down, C/O severe pain, redness and weakness. U 10/25/2001 10/25/2001 0 NONE PVT PVT PPD- R arm 1
0177235 11/06/2001 CA 27.0 27 M 11/01/2001 Had flu vaccine administered 10/31/01 and developed sore throat, achy, temp, sore muscles axilla area L arm. 14 hrs after vaccine given. 10/31/2001 10/31/2001 0 PVT PVT Hydrocodone PRN, Soma PRN NONE Chronic asthma 1
0177236 11/06/2001 TX 34.0 34 F 10/29/2001 Teeth started hurting, vision blurred Y 10/29/2001 10/29/2001 0 PUB OTH 1
0177237 11/06/2001 NC 1.6 1 .7 F 10/27/2001 Lt thigh - 1/2 cm x 3cm erythema, confluent,NT area no fever. At injection site. Tx 1 - cool compress, motrin q6 hrs, f/u prn if worsens. Y Y 10/25/2001 10/26/2001 1 N/A PVT PUB Synthyroid NONE Congenital hypothyroidism, piriform stenosis 1
0177238 11/06/2001 IN 3.0 3 F 10/30/2001 Developed a local reaction 5cm at site of immunization. U 10/29/2001 10/30/2001 1 N/A PVT UNK NONE NONE 1
0177239 11/06/2001 IN 3.0 3 F 10/30/2001 4x9cm red swollen area surrounding the area of immunization appeared the did next day. U 10/29/2001 10/30/2001 1 NONE PVT OTH NONE NONE 1
0177240 11/06/2001 NC 2.0 2 .0 F 10/12/2001 Swelling, pain and erythema at injection site and in upper arm. Y 06/20/2001 06/21/2001 1 PVT PVT Penicillin NONE Sickle cell anemia. 1
0177241 11/06/2001 NC 14.0 14 M 10/12/2001 Localized allergic reaction with swelling, erythema, warmth, fever. Y 08/15/2001 PVT UNK Hydroxyurea NONE Sickle cell anemia. 1
0177242 11/06/2001 AZ 0.5 0 .2 M 11/01/2001 High pitch crying for 2 days. Y 08/01/2001 08/02/2001 1 PVT PVT NONE Infantile colic. 1
0177243 11/06/2001 AR 0.2 0 .2 M 10/29/2001 Unconsolable crying times four hours. Refusing to feed. Temperature 101.5. N 10/29/2001 10/29/2001 0 PVT PVT Mylicon, Hytone ,capon,Saline. Reflux and atopic Dermatitis. NONE 1
0177244 11/06/2001 IN 0.6 0 .5 M 10/30/2001 Pt developed vomiting and rash around face after a fourth IPV and fourth Prevnar were given in error. Symptoms started an hour later. Pt was taken to ER and was treated for urticaria with Benadryl and released. Y Y 10/10/2001 10/10/2001 0 PUB PUB NONE NONE 1
0177245 11/06/2001 AL 1.6 0 .7 F 10/01/2001 Pt developed swelling in right thigh 1 day post vax. Two days post vax lesion became red and redness, warmth, swelling and pain increased over 2 days until presentation in office. Y Y 09/28/2001 09/29/2001 1 PVT PUB NONE 1
0177246 11/06/2001 TX 1.2 0 .9 M 10/26/2001 On 7/27/01 pt noted to have a temperature of 101.9F which lasted for 48 hours. Pt was cranky and developed a knot on the thigh that took a week to go away. Y 07/27/2001 07/27/2001 0 PVT PUB Nizoral 2% cream Fever, cranky~Pneumo (Prevnar)~2~0.75~In Patient 1
0177247 11/06/2001 FL 1.0 0 1 F 10/26/2001 Herpes zoster on leg 7 months after immunization. Y Y U 03/29/2001 10/26/2001 211 PVT PVT CHC, Recurrent on umbilical hernia, faint, 38 weeks preamic 1
0177248 11/06/2001 NC 28.0 25 M 10/19/2001 One day after Anthrax shot #3, noted pain and tingling in right arm (same as shot) from axilla to IV & V fingers. Has continued off and on since then and seemed to be exacerbated by subsequent Anthrax shots, of arm. No other local reaction. N 10/15/1998 10/16/1998 1 MIL MIL Penicillin allergy 1
0177249 11/06/2001 CA 0.08 0 .1 M 11/02/2001 Lethargy with vomiting. Local erythema, swelling and tenderness. Y 11/01/2001 11/02/2001 1 PVT PVT 1
0177250 11/06/2001 DC 24.0 24 F 10/19/2001 Hyperemia of the arm and upper trunk. immununization feeling of heat: symptoms occurred after one and a half hours, after vaccination WH LPV and Hep B. Trance instructed to lay down on a bed. Benadryl 7wal im, Hydrocorizine sodium succimate 100 mg after 1 hour skim normal. Feel normal. Y Y 10/19/2001 10/19/2001 0 OTH OTH Multivitamins Food Allergy - MS6; Contact dermatitis/allergy/to metals. 1
0177251 11/06/2001 PA 1.0 1 .2 F 10/30/2001 Morbilliform rash. Temp 105 Y Y 10/18/2001 10/30/2001 12 PVT PVT NONE NONE NONE 1
0177252 11/06/2001 MN 0 .7 M 11/02/2001 Mother states baby started shaking about 1pm and baby trembled about 1 hour. Baby also started to be febrile. Mother instructed to bring baby in to be checked. Treatment: Tylenol monitoring no other reason for fever. Y 11/02/2001 11/02/2001 0 NONE PVT PVT NONE NONE NONE 1
0177253 11/06/2001 PA 47.0 47 M HA, fever, flu like symptoms, eye twitching, joint pain same S and S after last hep B on 09/06/2001 Y U 10/22/2001 10/27/2001 5 NONE PVT PVT Lipitor MS Hx MS 1
0177254 11/06/2001 MI 5.0 5 F 10/29/2001 DTap positive reaction: 2 in by 3 in welt, which increased in size the next day. Seen at Urgent Care. Diagnosed as cellulitis. On Cefzil 250 BID for 10 days. Much improved by next day. To be reviewed after medication finished. Y 10/22/2001 10/23/2001 1 PVT PVT NONE Allergic to amoxicillin lump in leg~DTP + Hib (Tetramune)~1~0.00~In Patient 1
0177255 11/06/2001 CA 11.0 F Pt developed urticaria, 24 hours, post vax. Y PVT PVT 1
0177256 11/06/2001 CA 53.0 52 M 10/30/2001 About 1 hours, post vax, the pt was in an MVA (vehicle was seen to move erratically, then drive off road and down an embankment). Pt has no memory of the accident. Subsequent vaccines are being held due to concern about reaction. Y Y 06/08/2001 06/08/2001 0 EEG-abn PVT OTH Wellbutrin NONE History of depression 1
0177258 11/06/2001 CA 18.0 18 F Pt developed local erythema and swelling on injection site after Varivax #2. Y 08/22/2001 08/22/2001 0 PVT PVT UNK 1
0177259 11/06/2001 ND 2.0 1 .0 M 10/22/2001 Pt had Varicella vaccine on 1/14/00. He was seen in the clinic on 6/12/01 for a probable chickenpox. Doctor advised Benadryl and Caladryl. Y Y 01/14/2000 06/12/2001 515 NONE PVT OTH UNK UNK NONE ND0108 1
0177260 11/06/2001 ND 5.0 1 .3 M 10/20/2001 On 10/19/01, the pt broke out with a rash. On 10/21/01, the pt developed a fever of 101F and itching. Rx'd with Tylenol and Amoxicillin (for Otitis). Y Y 04/11/1997 10/19/2001 1652 NONE PVT PUB NONE NONE NONE ND0107 1
0177261 11/06/2001 NV 43.0 43 F 10/29/2001 On 10/27/01, pt had itching on anterior left forearm and scratched. It was followed by "small, red bumps". Then the left arm and hand curled upward, elbow flexed for 1 second every second. While arm is having trouble, left leg goes numb while walking. She states she only stops when this happens and has never fallen due to this condition. The pt states she has periodic burning and that the rash only lasted 15 minutes. She states that the paralytic condition has happened 4 times in the last 15 minutes. She cannot be specific with time frames or period of times in which this condition lasts or intervals of occurrence. She has not been to see a PCP but has been strongly encouraged to do so. U 10/25/2001 10/27/2001 2 NONE PUB OTH 1
0177262 11/06/2001 FL 5.0 0 1 F 10/31/2001 Twenty to thirty vesicular lesions noted, onset 2 days prior to exam. Exposed to chicken pox at school past several weeks. Afebrile. Benadryl po, Aveeno bath and fluids. Y 04/23/1997 10/02/2001 1623 NONE PVT OTH NONE 1
0177263 11/06/2001 TX 14.0 14 M 10/30/2001 The child received 1st Hep-A and Hep-B shots and felt faint and then had blood drawn. After blood was drawn the pt fainted and had a seizure. The seizure lasted 5-10 seconds and pt woke up disoriented. The child was sent to ER for further evaluation. Y Y 10/29/2001 10/29/2001 0 PUB OTH NONE NONE 1
0177264 11/06/2001 FL 7.0 1 .3 M 11/01/2001 10/15/2001 Lesions noted. Y 01/26/1996 10/31/2001 2105 PVT PVT PPD NONE NONE 1
0177265 11/06/2001 CA 8.0 8 M 10/22/2001 Rash started about an hour after vaccine was given. Y 10/15/2001 10/15/2001 0 NONE PVT PUB NONE NONE NONE 1
0177266 11/06/2001 MN 38.0 F 10/30/2001 Pt has had muscle/joint aches starting about one week after tetanus booster. Y Y UNK UNK 1
0177267 11/06/2001 MA 56.0 56 F 10/26/2001 Axillary node swelling, fatigue, left arm soreness; starting 3 days after vaccine lasting 1 week. Motrin and ice pack. Y 10/09/2001 10/22/2001 13 PVT UNK 1
0177268 11/06/2001 GA 1.0 1 .0 F 10/29/2001 Developed chicken pox lesions (few and scattered) one week after Varivax. Advised Tylenol and supportive measures. Y 10/16/2001 10/22/2001 6 PVT PUB 1
0177269 11/06/2001 PA 2.0 1 .3 F 10/29/2001 Fever and pale, shallow breathing 30-60 minutes. Hx neonatal seizure. Parent took child to ER in Vermont, saw MD porb atypical seizure. Y Y 01/26/2001 02/03/2001 8 CT Scan, EEG and blood work in hospital ER. PVT PVT NONE Perinatal asphyxia seizure disorder (resolved 2 months of age) 1
0177270 11/06/2001 MN 0.2 0 .2 F 10/29/2001 Vaccine administered 10/25/01. Mother reports child fussy on Thursday. Had slight fever on Friday. On Saturday child's face pale and non-responsive. Unable to arouse. Mother felt child was not breathing-began CPR. Child came to but eyes would roll back in head and then would come to again. Took to ER at Redwood Falls Hospital. By that time child aroused and crying Y Y 10/25/2001 10/25/2001 0 NONE PUB PUB NONE NONE NONE 1
0177271 11/06/2001 AZ 1.5 1 .5 M 10/29/2001 Swollen and painful shot site in left upper thigh. Local reaction to vaccine. Y N 10/24/2001 10/26/2001 2 PVT PUB Mild URI NONE 1
0177272 11/06/2001 PA 2.9 2 .9 M 10/29/2001 Developed pustules on back and chest on 10/24/01. Very itchy, spreading, approximately 225. Y 05/01/1996 10/24/2001 2002 NONE PVT PVT Biaxin NONE Allergy to blueberries, atopic dermatitis 1
0177273 11/06/2001 ME 56.0 56 F 10/25/2001 Around 4:30 noticed discomfort to left forearm, swelling, redness,and warm to touch. Following morning, 10/12/01 area of redness larger, pain and temperature of 101.2 F. Seen at PCP and given antibiotics, antihistamines, and pain meds. Med administered should have been PPD for routine TB testing at place of employment. Y Y 10/16/2001 10/16/2001 0 PVT PVT NONE NONE 1
0177274 11/06/2001 CA 0.5 0 .5 F 10/30/2001 On Oct 22nd 2001 pt's mother noted pink line across left thigh. Then it became a pink spot with a high temperature of 104.5 F. Had low grade fever following day of vaccination. Y Y 10/17/2001 10/18/2001 1 Urine, CBC, and chest x ray was obtained and all were within normal limits. PVT PVT NONE NONE NONE 1
0177275 11/06/2001 IL 12.0 12 F 10/31/2001 Mother contacted clinic stated brought child to Dr with complaint of high fever for 2 days after having shot. Temperature was 103 and consistent. Dr had blood work and urinalysis and stated was either viral or related to vaccine. Spoke with mother on 10/31/01 and she stated child's temperature was finally back to normal this AM. Y Y 10/27/2001 10/27/2001 0 Bloodwork and urinalysis were done but no results given. PUB PUB NONE UNK sinus problems, and allergy to milk 1
0177276 11/06/2001 GA 1.5 1 .0 M 10/29/2001 Developed probable shingles on leg. No hx of natural chicken pox. History of receiving Varivax. U 04/13/2001 10/28/2001 198 NONE PVT PVT NONE NONE 1
0177277 11/06/2001 IL 33.0 33 F 10/29/2001 Pt has body aches, severe nausea, vomited. Sx 3 days post administration of vaccine. Local swelling and pain, inflammatory at site of vaccine. Pt still has knot today. Y 10/23/2001 10/26/2001 3 NONE PVT PVT Singulair, Flonase, Vioxx, Albuterol inhaler Asthma 1
0177278 11/06/2001 FL 44.0 44 F 10/30/2001 Donor had rxn after leaving center. Felt clammy, sweaty. and nauseated. Y Y 10/02/2001 10/02/2001 0 OTH OTH NONE NONE NONE 1
0177279 11/06/2001 GA 64.0 64 F 10/30/2001 Pt called on 10/30/01 with complaints of reaction at injection site. Pt stated that arm was sore the next day after I got my shot. On the 19th he saw his doctor because it was red, and warm to touch. Pt stated the Dr said I had a bacterial infection and gave an antibiotic. My arm is fine now, but I knew you would want to know The Dr asked if the nurse cleaned my arm good with alcohol. I told him she certainly did and she used a new needle and disposable syringe. I am not upset, I will continue to get my shots at the health dept. the nurse was very nice. Y Y 10/15/2001 10/16/2001 1 PUB OTH MVA and cut finger Allergy to codeine 1
0177280 11/07/2001 AR 1.7 F 11/01/2001 Information has been received from a literature article concerning a 33 month old female pt who, at the age of 19 months, was vaccinated with 1 dose of pneumococcal vaccine 23 polyvalent. Subsequently, the pt developed otitis media and bacteremia from sero group 12 (pneumococcal bacteremia). Eight months later, the pt developed a second episode of bacteremia with sero group 19F. It was noted that both isolates were susceptible to penicillin and ceftriaxone. The pt was not taking antimicrobial prophylaxis at the time of either infection. Upon internal review, the pt's bacteremia with sero group 12 and 19F were considered to be "Other Important Medical Events". F/U states: It was noted that this information was received from medical records of all cardiac transplant pts receiving their care at a hospital from 3/90 to 11/00 that were reviewed for cases of invasive bacterial infections caused by S. pneumonia that occurred after transplantation. The risk factors for the development of invasive pneumococcal disease included African-American race, transplantation at age less than 12 years and having idiopathic cardiomyopathy as the indication for transplantation. It was noted that the 1st infection occurred at median age of 20 months post/transplant (range 3 to 48 months). Fever over 101F was the presenting sign/symptom in 75% of cases. Other clinical presentations included pneumonia, otitis media and petechia/purpura. In 15% of episodes pts had received a course of oral antimicrobial therapy within 30 days before their invasive disease. All pts were taking immunosuppressive medications at the time of infection including cyclosporin, azathioprine, systemic corticosteroids and mycophenolate mofetil. It was also noted that 4 pts were vaccinated with 1 dose of pneumococcal vaccine 23 polyvalent and developed similar eventss (WAES01102590, 01104800, 01104801 and 01104803). No further information is available. It has been determined that WAES01104802 is a duplicate of WAES01104800. Therefore, WAES01104802 is being deleted from our files and the reports consolidated into WAES01104800. U Blood cultures-bacteremia with sero group 12 and again with sero group 19F OTH OTH Immunosuppressive medication Immunosuppression Cardiac transplantation; otitis media WAES01104802 1
0177281 11/07/2001 AR 1.75 M 11/01/2001 information has been rec'd from a literature article titled Invasive pneumococcal infections in pediatric cardiac transplant pt's (Pediatric Infectious Disease Journal; 20(10): 945-950, Oct 2001) concerning a 21 mth old male pt with history of a cardiac transplant who was vaccinated with one dose of pneumococcal vaccine 23 polyvalent at one year of age. Concomitant therapy included an unspecified immunosuppressive medication at the time of infection. Subsequently, the pt developed an infection (pneumococcal bacteremia). Upon internal review the pt's infection (pneumococcal bacteremia) was considered to be an other important medical event. It was noted that this information was rec'd from medical records of all cardiac transplant pt's receiving their care at a hospital from 3/90 to 11/00 that were reviewed for cases of invasive bacterial infections caused by S pneumoniae that occurred after transplantation. The risk factors for the development of invasive pneumococcal disease included african-american race, transplantation at age <32 yrs and having idiopathic cardiomyopathy as the indication for transplantation. It was noted that the first infection occurred at median age of 20 months post transplantation (range 3 to 48 months). Fever >101F was the presenting sign/symptom in 75% of cases. Other clinical presentations included pneumonia, otitis media and petechiae/purpura. In 25% of episodes patients had received a course of oral anti microbial therapy within 30 days before their invasive disease. All pt's were taking immunosuppressive medications at the time of infection including cyclosporin, azathioprine, systemic corticosteriods and mycophenolate mofetil. It was also noted that four other patients were vaccinated with one dose of pneumococcal vaccine 23 polyvalent and developed similar events (WAES# 01102590,01104800,01104802, and 01104803). A copy of the published article is attached as further documentation of the patient's experience. U blood culture - no results given OTH OTH UNK Medical history: cardiac transplantation. Concurrent conditions: immunosuppression WAES01104801 1
0177282 11/07/2001 AR 3.75 M 11/01/2001 information has been received from a literature article titled invasive pneumococcal infections ins pediatric cardiac transplant pt's (Pediatric Infectious Disease Journal 20(10); 946-950, Oct 01) concerning an approximately 45 month old male pt with a history of a cardiac transplant, bacteremia with serotype 19F seen on a blood culture, pressure equalization tube placement for recurrent otitis media and a brief cardiopulmonary arrest during the tube placement. The pt was vaccinated with one dose of pneumococcal vaccine 23 polyvalent after his 1st infection (bacteremia) at 21 months of age. Concomitant therapy included an unspecified immunosuppressive medications at the time of infection. 2 yrs later, the pt developed a bacteremia with serogroup 9V. It was noted that the isolates were susceptible to penicillin and ceftriaxone. The pt was not taking anti microbial prophylaxis at the time of either infection. It was noted that this information was received from medical records of all cardiac transplant pt's receiving their care at a hospital form3/90 to 11/00 that were reviewed for cases of invasive bacterial infection caused by S pneumoniae that occurred after transplantation. The risk factor for the development of invasive pneumococcal disease included african-american race, transplantation at age <32 yrs and having idiopathic cardiomyopathy as the indication for transplantation. It was noted that the first infection occurred at median age of 20 months post transplant (range, 3 to 48 months) Fever >101F was the presenting sign/symptom in 75% of cases. Other clinical presentations included pneumonia, otitis media and petechia / purpura. In 25% of episodes pt's had received a course of oral anti microbial therapy within 30 days before their invasive disease. All pt's were taking immunosuppressive medication at the time of infection including cyclosporin. Azathioprine, systemic corticosteriods and mycophenolate mofetil. It was also noted that four other patients were vaccinated with on dose of pneumococcal vaccine 23 polyvalent and developed similar events (WAES# 0110259,01104800, 01104801, and 01104802). A copy of the published article is attached as further documentation of the pt's experience. This report is considered to be an "Other Important Medical Event". U blood culture/ bacteremia serotype 19F,and serotype 9V OTH OTH UNK Medical history: bacteremia, cardiac transplantation, cardiopulmonary arrest, otitis medic, otic tube insertion Concurrent conditions: immunosuppression WAES01104503 1
0177283 11/07/2001 AR 3.0 F 11/01/2001 Information has been received from a literature article titled Invasive pneumococcal infections in pediatric cardiac transplant pt's (Pediatric Infectious Disease Journal; 20(10): 946-950,10/01 concerning an approximately 5 year old female pt with a history of a cardiac transplant who was vaccinated with one dose of pneumococcal vaccine 23 polyvalent at the age of 42 months (3.5 years). Concomitant therapy included an unspecified immunosuppressive medications at the time of infection. almost 2 yrs later the pt developed a bacteremia with serogroup 14. Upon internal review, pt's bacteremia was considered to be an other important medical event. It was noted that this information was rec'd from medical records of all cardiac transplant pt's receiving their care at a hospital from 3/90 to 11/00 that were reviewed for cases of invasive bacterial infections caused by S pneumoniae that occurred after transplantation. the pt's involved developed pneumococcal bacteremia. The risk factors for the development of invasive pneumococcal disease included African-American race, transplantation at age < 32 years and having idiopathic cardiomyopathy as the indication for transplantation. It was noted that the first infection occurred at median age of 20 months post transplant (range 3 to 48 months). Fever >101F was the presenting sign/ symptoms in 75% of cases. Other clinical presentations included pneumonia, otitis media and petechiae, purpura. In 25% of episodes pt's had received a course of oral anti microbial therapy within 30 days before their invasive disease. All patients were taking immunosuppressive medications at the time of infection including cyclosporin, azathioprine, systemic corticosteriods and mycophenolate mofetil. It was also noted that four other pt's were vaccinated with one dose of pneumococcal vaccine 23 polyvalent and developed similar events (WAES# 01104800, 01104801, 01104802, and 01104803) A copy of the published article is attached as further documentation of the pt's experience. U Blood culture - bacteremia serogroup 14 OTH OTH UNK Cardiac transplantation and immunosuppression. WAES01102590 1
0177285 11/07/2001 AR 1.6 F 11/01/2001 Info has been recvd from a literature article titled Invasive pneumococcal infections in pediatric cardiac transplant patients concerning an over 2-year-old female pt who recvd vax at 19 mos of age. Subsequently, the pt developed an infection (pneumococcal bacteremia). Upon internal review, the pt's infection was considered to be an other important medical event. F/U states: The pt also developed otitis media with the 1st episode. It was noticed that both isolates were susceptible to penicillin and ceftriaxone. The pt was not taking prophylaxis at the time of either infection. It was noted that this information was received from medical records of all cardiac transplant pts receiving their care at a hospital from 3/90 to 11/00 that were reviewed for cases of invasive bacterial infections caused by S. pneumonia that occurred after transplantation. The pts involved developed pneumococcal bacteremia. The risk factors for the development of invasive pneumococcal disease included African-American race, transplantation at age less than 12 years and having idiopathic cardiomyopathy as the indication for transplantation. It was noted that the 1st infection occurred at median age of 30 months post/transplant (range 3 to 48 months). Fever over 101F was the presenting sign/symptom in 75% of cases. Other clinical presentations included pneumonia, otitis media and petechia/purpura. In 25% of episodes pts had received a course of oral antimicrobial therapy within 30 days before their invasive disease. All pts were taking immunosuppressive medications at the time of infection including cyclosporin, axathioprine, systemic corticosteroids and mycophenolate mofetil. It was also noted that 3 other pts were vaccinated with 1 dose of pneumoncoccal vaccine 23 polyvalent and developed similiar events (WAES01102590, 01104801 and 01104802). No further information is available. This is a consolidation of 2 reports concerning the same pt. It has been determined that WAES01104802 is a duplicate of WAES01104800. Therefore, WAES01104802 is being deleted from our files and the reports consolidated into 01104800. WAES01104802 was previously submitted to the FDA on 11/1/01. U Blood culture-serogroup 12 (pneumonia bacteremia); 8 months later-serogroup 19F (pneumonia bacteremia) OTH OTH Immunosuppressive medication Immunosuppression Cardiac transplantation; recurrent otitis media WAES01104800 1
0177287 11/07/2001 CO 48.0 48 F 01/07/2002 Information has been received from an RN concerning a 48 year old Hispanic female dietary aide who on 6/25/01 (also reported as 6/27/01 and 6/22/01), sometime in the PM, was vaccinated IM in the LA with a 3rd dose of Hep-B vaccine recombinant (yeast) (lot NDC0006-4775-00, also reported as lot 637691/1454K). On 6/27/01 (also reported as 6/26/01), at approx. 14:00, the pt experienced pain in the joints (wrists, arms, and knees), joint swelling and had a rash. It was reported that the pt was sent to the ER and was treated with Benadryl and prednisone and was released. It was noted that the pt continues to have mild symptoms for which workman's compensation will not cover. Follow-up info has been received from an RN which indicated that there might have been a temperature stability issue with the product due to the wholesaler and their shipping methods. It was noted that the vaccine was packed on an ice pack and "it took at least 3 days to arrive". Addition follow-up has been received on 10/22/01 from an RN which indicated that the pt had not completely recovered from the experience. It was reported that the pt also experienced "nerve damage", aches, could not go out into the sun for a long period of time and could not work in the heat (pt did kitchen work). The pt's aches and pain in joints, joint swelling, photosensitivity, head sensitivity and "nerve damage" were considered by the reporter to be immediately life threatening and "Other Important Medical Events". Additional information has been requested. Follow-up information has been received on 10/29/01 from an RN which indicated the pt was "fine". It was noted that she was still having a problem going out in the sun for long periods of time and that she could not work in the kitchen because of the heat. It was reported that the pt had not been dx'd with any other disorder and that the problem was both sunlight and heat. Follow-u[ info received from a registered nurse indicated that the pt had not recovered from her experience. The pt's aches and pain in joints (wrists, arms, and knees, joint swelling, photosensitivity, heat sensitivity and "nerve damage" were considered by the reporter to be immediately life threatening and other important medical events (OMIC). Additional info has been requested. Y Y N 06/25/2001 06/27/2001 2 It was also reported on follow-up, that the pt had unspecified lab/dx tests performed. OTH PVT Hydrochlorothiazide Hypertension WAES01070736 1
0177293 11/07/2001 SC 53.0 53 F 11/30/2001 Information has been received on 10/23/01 from a health professional concerning a 53 year old female who on 10/11/01 was vaccinated with "the standard dose", 0.5ml, of pneumococcal vaccine 23 polyvalent (lot 637487/1071K) and 1 dose of influenza virus vaccine. On 10/15/01, the pt went to the MD's office with a local reaction that was described as an area at the injection site that was swollen, red and hot. The pt also had symptoms of a sinus infection, with a cough and a fever. She was dx'd with cellulitis and was prescribed Augmentin for the sinus infection and the cellulitis, Atuss and Medrol. It was noted that the pt "is fine now" and has fully recovered. The reporter noted that the practice had been administering the pneumococcal vaccine 23 polyvalent vaccine for years and they have never had a problem. It was also noted that another pt (WAES 01106301) who was vaccinated from the same lot developed similar events. The reporter stated that she and another nurse are now concerned and afraid to use the rest of the lot. The reporter stated that she was grateful that a check would be done on this lot and reported that their practice would not administer any more of the vaccine until they received information on the results of the lot check. The records of testing prior to release of this lot have been checked by compliance and found to be satisfactory. This lot complies with the standards of the CDC and was released. Upon internal review, the pt's cellulitis was considered to be an "Other Important Medical Event". Additional information has been requested. F/U states the pt was also prescribed Augmentin for the sinus infection. Y Y 10/11/2001 10/15/2001 4 PVT PVT Lipitor; clonazepam; Prozac; Xenical Heavy smoking (1-2 ppd) and no allergies WAES01103264 1
0177294 11/07/2001 36.0 35 F 11/05/2001 This report was received from the pt and has not been verified by a physician or other healthcare professional. The pt reported that she had no adverse experience following receipt of her 1st injection of Engerix-B on an unknown date in 1995. One month later, also in 1995, the pt reportedly received her 2nd injection of Engerix-B. The pt reported that, approx. 1 month following the 2nd injection, her "stomach bothered (her) for at least 6 months". She also "began noticing muscle aches". The pt reported that she now has anemia, fibromyalgia and "possibly rheumatoid arthritis or lupus". She stated that she experienced "constant inflammation". She reported that she has seen a physician for these events; she did not specify the treatment of these events. She stated, "all of these symptoms may not be attributed to the Engerix-B vaccine, but most began shortly after the 2nd injection". She also reported that she received the 3rd injection of Engerix-B on an unspecified date. The unspecified stomach problem resolved after "at least 6 months". The outcome of the muscle aches was not specified. As of 10/22/01, the anemia, fibromyalgia, possible rheumatoid arthritis and possible lupus were reportedly ongoing. Possible lupus is considered "Medically Serious". Y N 02/01/1995 03/01/1995 28 OTH OTH Asthma 20010259521 1
0177295 11/07/2001 SC 75.0 75 F 12/05/2001 Information has been received from a health professional concerning a 75 year old female who on 10/25/95 and 10/18/01 was vaccinated with a 1st and 2nd dose of pneumococcal vaccine 23 polyvalent. On 10/18/01, a few hours, post vax, the pt returned with a reaction that was described as a very swollen injection site that was as hard as a rock. The pt was dx'd with cellulitis and on 10/18/01, she was put on treatment with oral cephalexin and prednisone. The pt was seen in the office on 10/20/01 and was doing better. The pt was seen 3 more times, the last on 10/27/01 and had fully recovered. The reporter noted that the practice had been administering the vaccine for years and they have never had a problem. Upon internal review, the pt's cellulitis was considered to be an "Other Important Medical Event". Additional information has been requested. F/U states: It was also noted that another pt who was vaccinated from the same lot developed a similar events (WAES01103264). The reporter stated that she and another nurse are now concerned and afraid to use the rest of the lot. The reporter stated that she was grateful that a check would be done on this lot and reported that their practice would not administer any more of the (pneumococcal vaccine 23 polyvalent) until they received information on the results of the lot check. The records of testing prior to release of this lot have been checked by CMP Compliane and found to be satisfactory. This lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Follow-up information from the health professional noted that the physician wanted to exchange this lot for a new lot number. Upon internal review, the pt's cellulitis was considered to be an other important medical event. No further info is available. Y Y 10/18/2001 10/18/2001 0 PVT PVT Xanax; Depo Estradiol; Prozac; spironolactone Aspirin allergy; smoking WAES01106301 1
0177300 11/07/2001 PA 12.0 12 M 12/06/2001 Information has been received from a consumer concerning her 12 year old white son who on 8/14/97 was vaccinated with a 3rd dose of MMRII (lot 617553/0217D). In 2/98, the pt told his mother, "I haven't felt very good for a long time". It was reported that the child was evaluated for depression, at that time, but that "different doctors had different opinions as to the child's dx". His mother further reported that he had "problems with his legs that come and go", and that the child's current physician feels that the symptoms might be caused by a virus. It was also reported that the child is currently taking "low dose" prednisone. Follow-up information, received from a physician on 9/4/01, revealed that the pt is currently under evaluation for neuropathy and myopathy. It was reported that he is presently seeing both a neurologist and an endocrinologist, however, he is still in the process of being evaluated and "worked-up". The physician stated that they have not yet identified any etiology behind the neuropathy/myopathy, with the possible exception of hypothyroidism, which was identified in the child (timeframe/date unk) and which has been "corrected for a while". The reporter felt that there is "a possibility" that the neuropathy and myopathy are related to vaccination with MMRII, however, "cannot say this for certain". Additional follow-up received on 9/25/01, indicated that the physician was administered the vaccine was retired and that the reporting physician did not have any additional information. Medical records were received from the vaccinating physician's office on 10/16/01. The child was frequently seen between 11/4/97 and 5/14/98 and during this time, his complaints included vomiting, diarrhea, sinus inflammation and congestion, dizziness, throat swelling and irritation, abdominal pain, loss of appetite, cough, headache, fever and swollen glands. He was treated with various antibiotics, including Zithromax, Pen-VEE K, Vibramycin, Cefzil, Levaquin, Cedax, Ceftin and Dynabac. It was noted that the antibiotics caused him to have diarrhea but that when taken off them, his sinuses were a problem. He was also placed on various medications for symptomatic relief. The physician also questioned possible lactose intolerance. Further information received on 10/16/01 that he was seen by an allergist who did not find an allergic cause for the sinusitis and he was dx'd with staph aureus, by an ENT physician. On 2/23/98, he was seen by a gastroenterologist for left lower quadrant cramping and diarrhea. He was also seen by another physician who felt the child was depressed. He recommended starting Zoloft which he never received due to the fact that his mother was not satisfied with his care and changed physicians. Another physician dx'd him with Epstein-Barr virus by a blood test in 3/98. He was also dx'd with a candida infection and treated with Diflucan. On 3/9/98, the MD approved him for "homebound schooling", as he had been out of school since 2/98. He continued to have diarrhea and sinus drainage from 6/98 to 8/98 and was treated with Bactrim and clindamycin. At that time, a cobblestone appearance was observed in the back of his throat and he stopped talking, in approx. May. The pt indicated that he was able to phonate and articulate but that it "hurts too much to do so". In 5/98, the pt started to have lower extremity weakness and he became increasingly weak and his gait became shuffling and slow, by /98. On 7/13/98, he was seen by a Pulmonologist with additional complaints of fatigue and weakness. On 9/8/98, it was reported that "several weeks ago" he began to complain of leg stiffness and basically had become bed ridden for the entire summer and had difficulty getting on and off the toilet. On 9/4/98, he was seen in ER for neurological evaluation. The next day, he presented to another hospital for elective admission. It was noted that he would not move his lower extremities but was able to wiggle his toes. He complained of tingling in his left lower extremity and tone was markedly increased in all extremities but appeared to be voluntary muscle contraction. Infectious disease physician was consulted and he was started on Ancef, 1 gram IV q8h. The pt was treated with metronidazole 250mg tid. The pt was transferred to a psychiatric facility for inpatient evaluation. He was discharged on Lomotil 2 tablets po q8h prn diarrhea. On 9/28/98, he was noted to have a rash in his groin area and was placed on treatment with Tristatin cream and was taking Diflucan. He was put on Synthroid for hypothyroidism. On 12/5/98, a physician's order was written for a walker for 12 months. He started physical therapy again and was noted to have balance and equilibrium difficulties. Low back pain was improved. He reported having muscle twitches, at times. He had a "moon-type face". Slight kyphosis was noted. Trace mild edema was present. Hypothyroidism, EBV, Candida infection, cobblestone appearance of the throat, throat swelling and irritation, "stopped talking", enlarged liver and spleen, cold sensation and temperature intolerance, vomiting, diarrhea, sinus infection, dizziness, abdominal pain, loss of appetite, cough, headache, fever and swollen glands were considered to be incidental findings. Myopathy and neuropathy were considered to be disabling. Additional information has been requested. Follow-up info received from a physician on 11/30/01 indicated that the onset date of the pt's adverse events was 11/4/97. Follow-up info has been requested from the neurologist that is currently evaluating the pt. Hypothyroidism, EBV, Candida infection, cobblestone appearance of the throat, throat swelling and irritation, "stopped talking," enlarged liver and spleen, cold sensation and temeprature intolerance, vomiting, diarrhea, sinus infection, dizziness, abdominal pain and tenderness, loss of appetite, cough, headache, fever and swollen glands were considered to be incidental findings. Myopathy and neuropathy were considered to be disabling. Additional info has been requested. Y Y Y N 08/14/1997 11/04/1997 82 Cranial nerve exam revealed decreased movement of the palate but was otherwise nml. Stool specimens were positive for C. diff. UA was sent; CT of the sinuses revealed some mild inflammation; MRI of the brain-nml; CXR-nml; CBC-nml except for increased total protein of 8.1 which "may have been due to dehydration". LP-glucose 64, protein 38 and culture, gram stain, cryptococcal antigen and India ink stain were all neg; Electrodiagnostic study revealed questionable muscle disorder; SGOT 32 (high); IGA (high); Serum albumin (low); TSH (low); IGM (high) PVT PVT NONE Allergy to molds (PCN); cleft palate at birth; large for his age; Striae over his lateral "obese" abdomen and back; purulence in the posterior pharynx; headaches and pain under his eyes; cleft palate repair; digestive gas symptoms; epigastric pain; speech rehabilitation WAES01082207 1
0177301 11/07/2001 HI 1.0 1 .0 F 10/19/2001 ITP that responded to IVIG. Y 2 Y 09/25/2001 10/10/2001 15 Platelet count 5000 PVT PVT NONE HI0112 1
0177302 11/07/2001 CA 4.0 4 F 11/01/2001 The pt was covered in large bruises all over her body. She had a nose bleed and petechia all over her body including eye area and bleeding gums. She was treated in ER and then transferred to the hospital for an overnight stay and treated with IV and Renrho. Diagnosed with thrombocytopenia Y Y Y 1 N 03/28/2001 04/05/2001 8 Blood work done on 4/7/01 PUB OTH NONE 1
0177303 11/07/2001 WA 1.25 1 .3 M 10/07/2001 Pt stopped talking, become spacey and stopped responding. per doc 212752 patient has never developed appropriate speech language communication. He was right on track before the vaccines. His intestinal system is still messed-up and he is now on undergoing treatment to rid his body of mercury and other toxins. *F/UP report on 3/21/03: Autistic Sx's, Severe language loss.* Y N 02/29/1996 PVT OTH NONE NONE 1
0177304 11/07/2001 OR 1.25 1 .0 M 11/02/2001 Pt had 3 seizures on 10/29/01 and was hospitalized. Y Y 3 U 10/13/2001 10/29/2001 16 Normal w/u for seizure including LP cultures and viral cultures. PVT PVT NONE URI Chronic non-specific diarrhea 1
0177305 11/07/2001 MO 56.0 56 M 10/31/2001 Pt developed a fever of 102.4F max, several rigors, headache, nausea and severe achiness in the left arm. Treatment: Tamiflu, droperidol, Toradol and Tylenol. Pt felt better at discharge. Dx'd with viral illness (monocytosis). Y 1 Y 12/18/2000 12/18/2000 0 On 12/19/00 WBC-3,200; Platelets-111,000; on 12/20/00 WBC-3,100; Platelets-94,000 OTH OTH Prevacid; Vitamin B; Multi-vitamins; ASA Possible viral illness-monocytosis Bladder cancer; recent viral meningitis (9/00); Status post chemo; Viral infection 1
0177306 11/07/2001 CA 42.0 42 F 10/24/2001 On 10/14/99, I woke up feeling horrible with heaviness in my chest and pain when breathing. That afternoon I was taken by EMS to the ER and was examined and released with a dx of pneumonia and was given prescriptions for Biaxin and Vicodin. The next day, 10/15/99, I felt worse and again was taken by EMS to the ER and within hours of arrival at the hospital, my heart stopped. I had a pericardial effusion (tamponade). My heart stopped 3 X, once for 20 minutes. My kidneys failed and I went into a coma. My parents came to the hospital and they were told that I was most likely going to die. My family and friends prepared themselves for my death. I spent a total of 3 weeks in the hospital, much of it in ICU, experiencing a myriad of heart problems, kidney dialysis and miscellaneous invasive procedures. After release from the hospital, I did not get better. I was re-admitted to the same hospital on 11/18/99. After 4 days of testing, I was dx'd with Addison's Disease and Hypothyroidism. When I received the medication for these conditions, I felt better and went home. I was off of work from mid 10/99 until 1/00. On 1/21/00, I again felt heaviness in my chest and went to ER. I was immediately admitted and surgery was later performed. I had a pericardial window and 600cc of fluid drained. I missed more work. On 3/13/00, I went to ER and was dx'd with pericarditis, although there was no fluid build up due to the pericardial window. From 3/00 to present, I have had recurrent pericarditis. It occurs regularly and is very painful. I now have 3 autoimmune conditions that I did not have prior to receipt of the anthrax vaccinations. My Rheumatologist is considering putting me on Methotrexate, as well, for Prednisone sparing purposes. I have gained 50 pounds and am quite obese as a result of the continuous steroid use. I am experiencing early onset menopause due to my endocrine problems. The annual follow up states that, "I will have autoimmune problems for the rest of my life as a result of these vaccinations: Addison's disease, autoimmune hypothyroidism and recurrent pericarditis. I had none of these conditions prior to the anthrax shots. My life expectancy has been shortened." Y Y Y 28 Y N 08/07/1999 10/14/1999 68 Too many to list MIL MIL Hydrocortisone; Florinef Acetate; Levothyroxine; Colchicine; vitamins; calcium; Prednisone; Vicodin NONE NONE 1
0177307 11/07/2001 CA 51.0 51 F Two and a half years ago I had 2 Lyme vaccinations on 02/19/1999 and 03/19/1999. Since then I have developed auto-immune arthritis in all of my joints. The annual follow up states, "I still don't know if my low-grade inflammatory process and elevated rheumatoid factor all due to the vaccine, but I still have those problems and occasional "flu-like" symptoms that mimic fibromyalgia, as well as moderate inflammation joint changes. Y N 03/19/1999 Elevated rheumatoid factor; Sed Rate; Abn CRP; Abn X-rays in several joints (back, neck, shoulders, knees, hips, hands) and chronic inflammation PVT OTH NONE NONE NONE 1
0177308 11/07/2001 TX 91.0 91 F 10/31/2001 The patient rapidly developed respiratory failure with oxygen desaturation days after receving the vaccination. Annual follow up states that pt did not recover. Replied to your letter dated 06/26/02 by fax on 07/17/02. Death certificate sent, as requested. Annual follow up on 11/25/03: "It is unknown if the patient recovered from the adverse event." Death Certificate Info: Immediate cause: Pneumonia. Underlying cause: Advanced Dementia. Significant Conditions: Diabetes Follow up on 06/01/2004: states it is unknown if the pt recovered from the adverse event. Y Y U 10/22/2001 10/29/2001 7 OTH MIL SA0113 1
0177309 11/07/2001 TX 84.0 84 F 10/31/2001 The patient rapidly developed respiratory failure and oxygen desaturation days after vaccination. Transferred to hospital. Per F/U on 6/25/02: immediate cause of death; respiratory failure and pneumonia. Y 11/09/2001 Y Y U 10/22/2001 10/29/2001 7 OTH MIL Zoloft, Deparene, Phenobarbitol, Cogentin, Premarin Dementia, Hypertension, Hypothyroidism SA0112 1
0177310 11/07/2001 WV 72.0 72 F 11/06/2001 The patient became lightheaded and dizzy 4 hours post vax. The patient experienced nausea and vomiting during the night, which abated by the next morning. Y 10/18/2001 10/18/2001 0 PUB PUB Cholesterol Inhibitor, Hormones NONE Hypercholesterolemia, osteoporosis and arthritis 1
0177311 11/07/2001 OH 35.0 35 M 10/25/2001 Post vax, the patient experienced local erythema and pain on the right deltoid. U 10/22/2001 10/22/2001 0 NONE OTH OTH Advair, Accolate, Zestril, Claritin, and Proventil NONE RAD, DM II, HTN, Hypercholesterolemia, SAR 1
0177312 11/07/2001 CA 51.0 51 F 10/22/2001 The patient experienced swelling, pain, and a fever at the injection site. Y U 10/19/2001 10/20/2001 1 PVT PUB NONE Sulfa, Tetanus Vaccine CA010119 1
0177313 11/07/2001 LA 63.0 63 F 10/24/2001 Post vax, the patient experienced "feeling funny", lips tingling, sore across shoulder and arm. The next day the patient experienced body pain, headache, sore throat. The next day the patient was nauseated, extra tired, had an earache, and nasal passages were stopped up. The patient also experienced coughing and feeling like she is coming out of her skin, sneezing, a bad taste in her mouth, dizzy and a stomach ache. The patient's heart was beating faster with heavy breathing. The patient was also hot then cold. The patient was treated with an antibiotic. Y U 09/29/2001 09/29/2001 0 OTH PVT Zantac, Tylenol, Excedrin, Estrace Cream, Monistat, Vagisil, Citrucil, Refresh for Eyes, Aspirin, Nasal Crom. Herpes Allergies, fibromyalgia, arthritis, IBS, osteoporosis 1
0177314 11/07/2001 CA 53.0 53 F 11/01/2001 Post vax, the patient experienced injection site erythema, pain and edema. The patient was treated wtih cool compress and NSAID. Y 10/31/2001 10/31/2001 0 PUB UNK Hydrocortisone Addison's Disease, Asthma 1
0177315 11/07/2001 WA 62.0 62 M 10/31/2001 Post vax the patient developed redness, swelling, heat and pain at the injection site. U 10/30/2001 10/30/2001 0 NONE PVT PVT 1
0177316 11/07/2001 IL 6.0 6 F 10/31/2001 Post vax the patient was brought to the office with a rash. There were multiple macules 1mm, red raised areas surrounding 1 1/2 cm clearing surrounding the injection site. The site itself had redness, warmth and swelling. The patient was treated with Claritin. U 10/25/2001 10/30/2001 5 NONE PVT PVT Singulair, Proventil, Flovent Bronchitis Asthma 1
0177317 11/07/2001 KS 88.0 88 M 10/30/2001 Post vax the patient's arm was swollen from the injection site down to the elbow. The patient was treated with Benadryl. Y 10/24/2001 10/25/2001 1 NONE PVT PVT NONE Cardiac Dsyrhythmia, CAD with CABG, Prostate Cancer 1
0177318 11/07/2001 WI 58.0 58 F 10/23/2001 Post vax, the patient developed a fever, fatigue, myalgia, nausea, loose stools and chills. Y 10/17/2001 10/19/2001 2 PVT UNK NONE NONE 1
0177319 11/07/2001 WA 83.0 82 F 10/31/2001 Post vax, the patient developed pain in the left arm radiating up to the neck. The patient was treated with ice. Y Y 10/30/2001 10/30/2001 0 PVT UNK Stool Softners, MUI NONE Iodine, Hyperlipidemia, HTN, asbestos exposure, Right renal cell carcinoma, colon cancer, EGD 1
0177320 11/07/2001 WI 48.0 58 F 10/30/2001 The patient experienced a fever, chills, myalgia, nausea and fatigue after vaccination. Y 10/17/2001 10/19/2001 2 NONE PVT UNK NONE NONE 1
0177321 11/07/2001 CT 19.0 19 F 10/30/2001 Patient presented 24 hours after flu shot with a headache, fever of 100.6 and myalgia. Y 10/25/2001 10/25/2001 0 NONE OTH PVT NONE NONE NONE 1
0177322 11/07/2001 SC 47.0 47 F 10/31/2001 Post vaccination the patient developed aching in all joints, especially arms and no energy. U 10/15/2001 10/29/2001 14 NONE PUB PUB NONE NONE NONE 1
0177323 11/07/2001 NY 82.0 82 M 10/29/2001 After vaccination on 10/23/2001 the patient developed pruritis and a rash all over his body, except his face. The patient was treated with Benadryl. Y 10/23/2001 10/23/2001 0 OTH PVT Lymphoma diabetes, cardiac disease, myasthenia gravis, HBP 1
0177324 11/07/2001 KS 34.0 34 F 11/06/2001 Staff ARNP here received flu shot and had anaphylactic reaction. 2 other staff members had allergic reaction (itching). Y 11/06/2001 11/06/2001 0 PUB OTH NONE NONE Allergy to ASA 1
0177325 11/07/2001 AZ 20.0 20 F 10/26/2001 Approximately 1 hr and 45 minutes after vaccinations pt phoned the clinic with complaint of abdominal pain,scratchy throat, and SOB. client was advised to call 911 for transport to ER. At 14:50 P/C to client . RE: status she advised she was driving to Er. At 15:00 client phoned from ER where she is receiving treatment. Y Y 10/26/2001 10/26/2001 0 OTH PVT Ritalin, oral contraceptive NONE Asthma, ADD 1
0177326 11/07/2001 AZ 0 .2 M 11/05/2001 Fever, irritable for three days. Y Y 10/31/2001 10/31/2001 0 PVT PUB NONE NONE NONE 1
0177327 11/07/2001 CA 1.0 1 .3 M 10/16/2001 Vomiting the same day PCV, DTaP and HiB were given. Phenergan supp 1/4 gid and Tylenol. Y U 10/12/2001 10/12/2001 0 PVT PUB NONE CA010118 1
0177328 11/07/2001 IL 0 .6 F 10/31/2001 Macular rash coalescing to form a patch mostly chest and abdomen. Y 10/26/2001 10/27/2001 1 NONE PUB UNK NONE NONE NONE 1
0177329 11/07/2001 NC 1.0 1 .0 F 10/25/2001 Within less than 10 minutes, post vax, the pt had an adverse reaction. The reaction involved an area of redness, measuring 4cm X 6cm with a 1.5cm X 1.5cm wheal, at the injection site. The pt also had redness on her chest and back. She was kept in the doctor's office for 1 hour to observe. Y 10/19/2001 10/19/2001 0 NONE PVT OTH NONE NONE NONE NC01095 1
0177330 11/07/2001 GA 0.5 0 .4 F 11/06/2001 High pitched screaming after Prevnar for 16 hours after injection. Only received Prevnar that day. No other IMM's administered on that date. Y 09/13/2001 09/13/2001 0 NONE PVT PUB NONE NONE 1
0177331 11/07/2001 FL F Vaccines at 4pm. At 8pm while burping, pt vomited chunks, went pale and limp. Was pale and limp for 45 minutes, then fine. Eating well and active. Y PVT PVT 1
0177332 11/07/2001 NE 0 .3 F 10/30/2001 Fever (temp 101), listless and irritability N 10/29/2001 10/29/2001 0 PVT PVT NONE NONE 1
0177333 11/07/2001 NY 0 .1 M 10/29/2001 Irritability, crying a lot, temp 100 at home. Y Y 10/25/2001 10/25/2001 0 PVT UNK NONE NONE NONE 1
0177334 11/07/2001 AR 0.5 0 .5 F 10/30/2001 Fever to 102, swelling of right thigh and irritability. Y Y 10/29/2001 10/29/2001 0 NONE PVT PUB NONE NONE 1
0177335 11/07/2001 MD 0 .3 M 10/30/2001 Child received immunizations 10/30/2001. Awake most of night, crying also had fever. Y 10/30/2001 10/30/2001 0 PVT PVT 1
0177336 11/07/2001 AL 2.0 2 .0 M 10/18/2001 Abdominal pain, intermittently times 7 - 10 days by mother's history. Lose stools at 10 days out, acholia stools times 2 days; resolved spontaneously. Believe c/w viral illness. Y Y 09/28/2001 09/28/2001 0 PVT PVT NONE None 1
0177337 11/07/2001 TX 2.0 2 .4 M 10/29/2001 Prevnar injection (5cc) IM given (R gm) at approximately 10:30 am. Returned to clinic 10/28/2001 at 14:00 pm. c/o redness, swelling and heat around injection site, extending downward covering R buttock (child did not fight or move during injection) Dr gave Keflex 125/5 TID and Zyrtec 1 tsp qd and to return if s/s increase or fever. Y 10/26/2001 10/27/2001 1 PVT PVT Motrin NONE NONE 1
0177338 11/07/2001 KY 1.0 1 .0 F 11/01/2001 Superficial, tender erythema, lateral right thigh, no abscess suspected, fever, but also having URI and otitis media. Y 10/25/2001 10/31/2001 6 PVT PVT AMOX 1
0177339 11/07/2001 KS 3.0 3 F 10/25/2001 Initial s/s were swelling and stiffness at the left vastus lateralis and left knee (10/23/2001). By late that evening rest scattered blotches were appearing on the left leg extending down to toes. After a number of doctor appt it was determined that Jena had inflammation of the blood vessels diagnosis a strep infection. The hemorraghic, area extended over most of her body and there is a possibly that chronic arthritis may localize in her joints. Y N 10/19/2001 10/23/2001 4 PUB PVT NONE NONE NONE 1
0177340 11/07/2001 IL 0.6 1 .6 M 10/17/2001 Fever for 5 days , stopped with appearance of rash on face and trunk. diarrhea started 10/5/01. Tx with TMP-PMZ for 4 to day 5. Rash and course typical of roseola. Y Y 10/02/2001 10/03/2001 1 Urine culture negative PVT PUB URI, nasal discharge, cold NONE 1
0177341 11/07/2001 TX 0.2 0 .2 M 10/31/2001 Mother describes urticaria the evening vaccines were given. Y 10/30/2001 10/30/2001 0 Sent to allergist PVT PVT NONE Ileal atresia with colsotomy 1
0177342 11/07/2001 HI 1.4 1 .5 M 10/31/2001 One day after receiving immunizations, left thigh noted to be red and swollen. Itchy, pt scratching at it. No fever. Not tender. Walks normally. On exam 8 X 13 cm area of induration and erythema surrounding injection site. No warmth, tenderness, or discharge. Treated symptomatically. Y U 10/29/2001 10/30/2001 1 NONE PVT PUB NONE Slight cough Hernia repair age 1 month. Gingivostomastis 5/01 1
0177343 11/07/2001 NJ 54.0 54 F 02/14/2003 Pt reported that she received injections of LYMErix on 4/13/99, 5/13/99, and 3/9/00. On an unspecified date in 2001, pt's right knee completely failed. She was seen by MD and reportedly advised that she would need to undergo knee replacement surgery. She stated that MD did not have a reason for her knee to go completely. The pt stated that she believed that LYMErix administration caused the knee problem. This report of a failed knee is considered medically serious because the pt was reportedly advised to undergo surgery. This report of a labeled event is being submitted as an expedited report by special FDA request per the 6/28/00 letter. Follow up received on 02/04/2002 states that there was no history of gout, Crohn's disease, or Lyme disease. There was no family history of rheumatoid arthritis or lupus. Concurrent medications included paracetamol for relief of arthritic pain, beginning 01/10/2001. Vaccine provider reports that the pt began to experience acceleration of arthritic pain of the right knee in February 2001. 11 months following receipt of the third injection of LYMErix. No swollen or warm joints were observed on physican examination. No joint fluid was obtained for analysis. No diagnostic laboratory evaluation was performed by the vaccine provider. He prescribed Vioxx and referred the pt to an orthopedic surgeon. The arthopedic surgeon injected hyaluronic acid into the pt's right knee on 07/12/2001, 07/19/2001 and 07/26/2001. The vaccine provider did not confirm that the pt will undergo knee replacement surgery. The acceleration of right knee arthritic pain was ongoing. The vaccine provider considered the event to be severe, disabling and possibly related to LYMErix administration. The vaccine provider also considered the event to be possibly relate dto the pt's pre-existing arthritis. *F/UP report on 3/3/03: Medical history included "mild" (according to the PT) non-inflammatory arthritis of the right knee.* Y Y N 03/09/2000 02/01/2001 329 UNK OTH PVT Tylenol w/Codeine UNK Mild, non-inflammatory arthritis of the right knee 20010260721 1
0177344 11/07/2001 PA 1.4 1 .3 M 11/05/2001 On 11/3 fever of 104 F, green nasal discharge. On 11/4 temperature reached 105 F, with seizure. Seen in ER and bathed, temperature dropped to 101. Pt was started on Zithromax. Y Y 10/05/2001 11/04/2001 30 NONE PVT OTH Zyrtec, Pulmicort NONE Asthma, spinal bifida repaired. 1
0177345 11/07/2001 CA 7.0 7 F 10/25/2001 On 10/16/01 Diagnosed with shingles by PMD preceded on 10/14/01 fever and painful rash for 2 days. Isolates offered by Merck to do testing to determine wild virus vs varicella vaccine per nurse at Dr's office. No further plan-discussed with mother. Y Y 02/06/1997 10/14/2001 1711 PUB PUB NONE CA010117 1
0177346 11/07/2001 CA 53.0 52 F 10/24/2001 Less than 24 hours later my upper arm started to ache. It aches all the time day and night. This has been going on for 2 months now. No other symptoms. I did consult an ER MD. 08/22/2001 08/23/2001 1 NONE PUB PVT NONE NONE CA010120 1
0177347 11/07/2001 PA 6.0 0 1 M 11/01/2001 Prruitic rash on chest and legs for 6 days (20 lesions) afebrile. Y 07/09/1996 10/25/2001 1934 NONE PVT PVT TB Tine Test Lederle NONE 1
0177348 11/07/2001 IL 1.0 0 1 M 10/29/2001 Came to clinic today with varicella like blisters (4) and redness about 3 cm diameter around blister. Mom stated child develop redness on site of injection on 10/25/2001 then develop fever on 10/26/2001 and 2 blisters came out on site of vaccination. Two days after 2 more blisters came out. 10/17/2001 10/25/2001 8 NONE PUB PUB Ventolin 1/2 tsp tid URI ecc wheezing 1
0177349 11/07/2001 MA 5.0 5 F 11/01/2001 Swelling and erythema at site: 9 x 15mm left arm. Y 10/30/2001 10/31/2001 1 PVT PUB NONE NONE 1
0177350 11/07/2001 FL 11.0 11 M 10/30/2001 Approximately 20 minutes after receiving vaccine, "face was twisting, drooling and was unable to talk" according to child's mother (who was called by front office staff at school). Child was taken to ER and received Benadryl injection, was discharged and returned to school the next day. Y Y 10/24/2001 10/24/2001 0 OTH PUB Ritalin NONE ADHD 1
0177351 11/07/2001 IA 1.5 1 .5 F 10/30/2001 Red swollen thigh at site of DTaP 48 hours after injection. Y Y 10/22/2001 10/23/2001 1 PVT UNK NONE NONE 1
0177352 11/07/2001 RI 5.0 5 M 11/01/2001 MMR 2 given on 03/20/2001. Approximately 3 hours later started to have noticeable bruising. On 05/05/2001 platelet count 25,000. Y 03/20/2001 04/14/2001 25 Platelet count 25,000 PVT PUB 04/13/2001 Serous Otitis Previous correction transposition of great vessels 1
0177353 11/07/2001 WA 1.0 1 .1 F 11/01/2001 Pt had varicella vaccine right lateral thigh SQ on 10/19/2001. On 10/29/2001 Mom noticed a small reddened area on right lateral thigh, by 10/30/2001 rededned area about the size of a half dollar and is tender touch. Y 10/19/2001 10/29/2001 10 NONE PVT PUB NONE NONE NONE 1
0177354 11/07/2001 PA 6.0 0 1 M 11/01/2001 30 pruitic lesions on chest and legs. Afebrile. Y 07/09/1996 NONE PVT PVT Tine test Lederle NONE Hear mumur, prob innocent 1
0177355 11/07/2001 MI F Developed varicella after receiving vaccine. Had been on steroid burst BD prior to immunizing. Y 09/28/2001 10/18/2001 20 PVT UNK Exacerbation RAD Reactive airway disease 1
0177356 11/07/2001 AK 30.0 F 11/05/2001 Right glutinous numbness/burning 1 hr after Hepatitis B injection with increasing discomfort locally to radiating to back. Prior local reaction at deltoid with # 1 Hepatitis B. N Normal Dipstick UA; ESR PVT UNK Vioxx NONE 1
0177357 11/07/2001 CA 3.0 3 F 10/30/2001 Pt had redness on left thigh at injection site. No complaints of pain, fever, difficulty with breathing or problem walking. Y 10/23/2001 10/25/2001 2 PUB PUB NONE 1
0177358 11/07/2001 MO 46.0 46 F 10/31/2001 7 X9 cm erythema to left deltoid. Y 10/24/2001 10/24/2001 0 NONE PUB OTH Allegra, Evista NONE 1
0177359 11/07/2001 PA 4.0 4 M 10/31/2001 Localized redness, swelling , itching at left deltoid. No fever. U 10/29/2001 10/30/2001 1 NONE PVT PVT NONE Ringworm NONE 1
0177360 11/07/2001 WY 3.2 3 M 10/30/2001 Myalgia and fever 103 F. 2 cm X 3 cm erythematous macule right arm. Y Y 10/24/2001 10/24/2001 0 NONE PUB PUB NONE NONE NONE 1
0177361 11/07/2001 NY 45.0 45 M 10/23/2001 Pain down length of right arm, numbess in arm down to fingers. Lump in muscle in shoulder. Y N 07/17/2001 08/10/2001 24 OTH PUB 1
0177362 11/07/2001 WI 2.3 1 .6 F 11/01/2001 Varivax given SC to left anterior thigh. 3 day later, she went ER for swelling of thigh. Seen at the clinic on 10/29-redness and swelling on left thigh lap anterior portion with ringed yellow papules. Clusters of yellow on ingunial fold. Serous fluid from 1 papule. Not tender. Warm, but no limp. Also red and swollen on right mid thigh. red macule on abdomen. Started her on po Benadryl. Seen following day-decreased swelling and redness. Y Y 10/26/2000 10/29/2001 368 NONE PVT PUB Pediazole Respiratory infection NONE 1
0177363 11/07/2001 MN 1.0 1 .3 M 11/02/2001 Shot given right thigh SQ at 0930. At 0935 parent informed NCS of redness. Area was red and blotchy 5cm by 3.5cm. Ice applied. Doctor examined, no respiratory symptoms. Order 3/4 tablespoon Benadryl. (given) After 15 minutes redness decreased. Mom will monitor at home, Given samples of Benadryl. Y 11/02/2001 11/02/2001 0 NONE PVT UNK NONE NONE 1
0177364 11/07/2001 MS 2.0 2 .1 M 11/01/2001 Large indurated warm tender swelling on left thigh with large area of erythema at injection site, normal gait. Febrile with papular rash on both UE's, non pruritic, patchy erythema on face. Y 10/30/2001 10/31/2001 1 NONE PUB UNK NONE 1
0177365 11/07/2001 MO 5.0 5 M 10/24/2001 10.23/2001 Headache, sore arms, severe chills although afebrile. 10/24/2001 Vomiting 7-8 times by 4pm referred to ER. Y Y 10/23/2001 10/24/2001 1 PUB PUB UNK UNK UNK MO2001056 1
0177367 11/07/2001 WI 18.0 18 F 10/13/2001 Vaccine administered at 4pm and approximately two hours post vaccination, pt experienced "generalized warmth". Next morning, experienced "generalized muscle weakness, fatigue and chest soreness." "It was hard to breathe." No site reaction. Went to MD who referred her to vaccine administrator. Dx'd with strept, 2 days later, on 10/5/01. Y Y 10/02/2001 10/02/2001 0 OTH PVT NONE 1
0177368 11/07/2001 OH 4.0 4 F 12/11/2001 Hives around mouth with pruritis on forearms, legs bilaterally, denies fever. Symptoms occurred 4 days after vaccination. No treatment given. U 10/22/2001 10/24/2001 2 NONE PUB PUB NONE Allergy to peanuts and eggs (mild hives) 1
0177369 11/07/2001 CA 1.4 1 .4 M 10/30/2001 Pt developed swelling and redness in left thigh. Pt walked with a slight limp and had pain in area when touched. He had a slight fever. Treated with cold compresses to site. Y 10/25/2001 10/26/2001 1 OTH OTH NONE Teething NONE 1
0177370 11/07/2001 WI 67.0 67 F 10/31/2001 Pt's left arm became swollen from deltoid to entire length of arm. She complained of discomfort and hives. U 10/29/2001 10/29/2001 0 NONE PUB PUB NONE 1
0177371 11/07/2001 SC 27.0 27 F 11/02/2001 Pt developed a 3 x 2 cm area of redness, warmth, tenderness and induration on right deltoid. Y U 10/30/2001 11/01/2001 2 MIL OTH Claritin, Levlen, allergy medication NONE Sulfa allergy, history of (+) PPD 1
0177372 11/07/2001 TX 5.0 5 F 09/25/2001 The afternoon of receiving vax, pt was running temperature and was quiet. Mother called Health Department to report. Pt was given Tylenol at 12:30 PM. Pt broke out in chicken pox later that night. U 09/25/2001 09/25/2001 0 PUB PUB NONE UNK 1
0177373 11/07/2001 HI 5.0 1 .1 F 10/30/2001 Pt developed chicken pox. She had greater than 100 lesions (including scalp) going through the typical varicella progression. The duration was approximately 1 week. There were several crusts 1/2 cm in diameter. Y 03/29/1997 10/15/2001 1661 NONE PVT PVT NONE NONE NONE 1
0177374 11/07/2001 NM 1.0 1 .1 M 10/30/2001 Pt developed a fine rash and erythema on legs, arms and trunk. Y 10/17/2001 10/29/2001 12 PVT PUB NONE Runny nose NONE 1
0177375 11/07/2001 IL 53.0 53 M 10/30/2001 Pt noted a firm area below left deltoid with moderate edema down to elbow. Y Y 10/25/2001 10/28/2001 3 NONE PVT OTH NONE NONE 1
0177376 11/07/2001 HI 1.0 1 .0 M 10/30/2001 Maculopapular rash time 5 on left deltoid (same site of Varivax) and times 1 on abdomen. Y 10/18/2001 10/28/2001 10 NONE PVT PVT NONE NONE NONE 1
0177377 11/07/2001 WV 88.0 88 F 10/30/2001 Vaccine received on 10/23/2001 at 3 PM. Arm became swelled at 6 PM. Nine PM pt had fever 105 F, chest congestion, cough, severe sore throat. 10/24/2001 pt called her physician. received Trimox 500mg antibiotic called in Rx. 10/25/2001 pt reported reaction to HD. Stated the swelling out of arm on 10/24/2001 in the PM. Continues to have chest congestion and feels tired. 10/30/2001 phone conference with pt. Still has chest congestion and fatigue. No fever or sore throat. "Is some better" Has 3 more days of antibiotics. Pt will call HD if any other reactions occur. Y Y 10/23/2001 10/23/2001 0 PUB PUB Triomterex, Trimox, Synthroid, Ipecral XL and vitamins Chronic dialysis; kidney removed Cardiac condition;no known allergies; 1 kidney removed ~Pneumo (no brand name)~~77.00~In Sibling WV0012 1
0177379 11/08/2001 OH 19.0 17 F 12/13/2001 The pt received her 1st injection of Engerix-B on an unspecified date; she had no adverse experience following receipt of this injection. She received her 2nd injection of Engerix-B and her 1st injection of Havrix on 3/20/00. An unspecified time, post vax, the pt was hospitalized due to pain in her liver, "her bilirubin being so high", and dehydration. The physician reportedly stated, "her liver is that of a geriatric pt". As of 10/23/01, the inflammation of the liver persisted. The outcome of the dehydration was not specified. The most recent info was received on 12/3/01. The pt's mother reported that the pt had been "really, really ill" and had been "in the hospital five out fo the last ten days." The mother reported that the pt's physicians "say there is no relationship" between the vaccines administered and the inflammation of the liver. Y Y N 03/20/2000 05/01/2000 42 A liver biopsy was performed and the mother reported that the pt "had inflammation of her liver with changes in the tissue but not the structure". PVT OTH Actigall (ursodiol); Advil (ibuprofen); Depo-Provera (medroxyprogesterone A) Asthma; Gallbladder removal (11/00); polycystic ovary syndrome 2001026149 1
0177381 11/08/2001 MN 67.0 67 M 11/01/2001 The pt's son reported that the pt, a 67 year old man, received a Fluzone vaccination, lot U0673FA, on 10/30/01. On 10/31/01, the pt experienced some form of seizure activity that resulted in hospitalization in the ICU on ventilation support. The physician is conducting further testing to establish the cause. Etiology to be determined. Y U 10/30/2001 10/31/2001 1 OTH OTH CT Scan was neg. Tests conducted for myocardial infarction were neg at this time but showed cardiac arrhythmia of frequent premature ventricular contractions. U2001011060 1
0177382 11/08/2001 GA 78.0 69 M 11/01/2001 It was reported by the pt's wife that her husband, a 78 year old man received a Fluzone '01-'02 vaccination on Friday afternoon, 10/26/01. On Sunday, 10/28/01, at 03:45, the pt awoke with a large moan, had a seizure and was taken by EMS to the hospital and was admitted. F/U received on 11/26/01, reports "Received letter from Vaers with release forms to send to doctors and hospital. Mailed on 11/11/01 to Vaers in Rockville, MD. (The pt) still has memory lapses and is to be follow-up by a Neurology specialist on 12/11/02. Follow-up with MD on 12/4/01. The hospital is mailing all information. Follow up on 11/20/2001: "This patient has not yet been seen in office." Y U 10/26/2001 10/28/2001 2 MRI; EEG; CAT Scan; EKG; X-rays; results not provided; FU states CAT scan, chest xray, EEG, and MRI all WNL PVT OTH Effexor, verapamil NONE Degenerative joint disease, HTN, GERD; F/U states: Arthritis in knees U2001011030 1
0177383 11/08/2001 PA 21.0 21 F 11/05/2001 On 10/22/01, by 21:00, pt had left back muscle spasms, weakness of left arm, left arm soreness (deltoid) muscle; progressed by 10/23/01 to inability to raise left hand or arm, increased left back pain, decreased sensation on left side of body from shoulder to foot. On 10/24/01, the left leg, left foot, left chest, left back, left arm and shoulder had weakness. Y Y N 10/22/2001 10/22/2001 0 Serum chemistry; ANA; Sed Rate; CBC; MRI of brain and spinal cord PVT PVT Plaquenil; Prevacid; Colexa NONE SLE 1
0177384 11/08/2001 GA 0.6 0 .6 F 09/20/2001 Pt came back, 30 minutes, post vax, with erythema (generalized) on chest and abdomen, thighs, legs, pelvic area and back. It was hot to touch. Pt was admitted to the hospital on 9/18/01 and came home on 9/19/01. Wheezing was stabilized with 1 nebulizer treatment at 17:00 on 9/18/01. Subsequently diagnosed by allergist with an allergic response to Prevnar at 1:10 dilution. Y 2 Y 09/18/2001 09/18/2001 0 Child was tested by allergist on 2/28/02 and on 3/6/02 with the same vaccines and found to have an allergic response to the Prevnar vaccine which resembled the AE reported. PUB PUB NONE NONE NONE GA01086 1
0177385 11/08/2001 GA 30.0 30 F 10/26/2001 In early AM 10/24/2001, pt's spouse states pt made gasping noise and then quit breathing. Spouse gave 2 rescue breaths and pt started gasping. Pt then stiffened up and tight hand curled inward. Pt had 2 episodes of this lasting about 25 minutes and then had period of confusion. Was transported to medical center and had CT scan that was negative. F/U with neurologist and he classified this as a non conclusive seizure. Y Y 10/23/2001 10/24/2001 1 Negative CT scan 10/24/2001 PUB UNK Brief episodes of nausea and mild dizziness w/menses 10/20/2001 Back problems GA01099 1
0177386 11/08/2001 GA 61.0 61 M 10/22/2001 Client received flu shot at health department in morning. Early afternoon wife called saying he was having a reaction to flu shot, dizzy, vomiting, sweaty. Referred to PMD wife called and said MD said it was reaction to flu shot. This was client's first flu shot. Has history of bronchial problems. PC 10/23/2001 pt fine, no more problems. Y 10/22/2001 10/22/2001 0 PUB PUB UNK Possible bronchial problems. GA01092 1
0177387 11/08/2001 GA 57.0 57 F 10/19/2001 After receiving vaccine the next am pt developed large amount of swelling in right arm, size of "baseball", temp 103, severe headache and back pain. Y 10/16/2001 10/17/2001 1 PUB PUB NONE GA01091 1
0177388 11/08/2001 NY 62.0 62 F 11/05/2001 Some slight swelling at sight of flu shot. Increased swelling at sight of pneumonia shot eventually growing from size of golf ball in circumference to an orange. Difficulty in raising my arm due to some pain. Red rash covered area and although faded quite a bit, still remains. Both shots in right arm due to node dissection left arm (breast cancer). Saw internist on 10/31/2001. Diagnosis allergic reaction. 21 pack 4mg methylprednisone tabs;Benadryl and Levaquin due to shortness of breath. Y U 10/29/2001 10/29/2001 0 OTH UNK Aciphex, tamoxifen, synthroid NONE Mold spore, dust mite, reflux, breast cancer (radiation) 1
0177389 11/08/2001 PA 32.0 32 F 11/01/2001 Employee called 11/01/2001 to report that she had developed left ear pain and achy neck accompanied by left shoulder discomfort which started Tuesday 10/30/2001. Injection given in left deltoid on Monday 10/29/2001. Also c/o left rib cage pain with a deep breath. Left arm no swelling, tenderness or redness. Physician notified, informed to take ibuprofen which she did. On 11/02/2001 she felt much better, no longer had left rib cage or shoulder pain. Still had "a little" ear and neck discomfort but improved since yesterday. Left deltoid looks fine, no redness or warmth, has full range of motion. Y 10/29/2001 10/30/2001 1 NONE PUB PVT NONE NONE Topical allergies, never tested (eg. make up) 1
0177390 11/08/2001 CA 72.0 72 F 11/02/2001 Pt received pneumonia vaccine on 11/01/2001. On 11/02/2001 arm hard, hot, painful, swollen and filled with fluid. U 11/01/2001 11/02/2001 1 PUB PVT 1
0177391 11/08/2001 CA 66.0 66 F 11/02/2001 Pt received pneumonia vaccine on 11/01/2001. On 11/02/2001 arm hard, hot, painful, swollen and filled with fluid. U 11/01/2001 11/02/2001 1 PUB PVT NONE 1
0177392 11/08/2001 KY 56.0 56 F 11/02/2001 1 inch by 3 inches warm raised area at injection site. Are is not sore or tender to touch. Area was noted 3 days after flu shot. Y 10/31/2001 11/02/2001 2 NONE PVT UNK Zoloft, Buspes History of diabetes for 1.5 years diabetes for 1.5 years KY2001082 1
0177393 11/08/2001 KY 30.0 30 F 11/02/2001 Left arm aches. Massaging feels good. Started after getting the vaccine. Pain from left shoulder to left hand. Y 11/01/2001 11/02/2001 1 NONE PVT UNK NONE NONE NONE KY2001083 1
0177394 11/08/2001 PA 56.0 46 F 10/01/2001 Soreness and erythema at injection site started 10/18/2001 and developed into 8 by 5 erythema with induration. Erythema and soreness finally resolved by 10/24/2001-10/25/2001. Y 10/17/1991 PVT PVT Restoril 1
0177395 11/08/2001 OK 51.0 51 F 11/01/2001 10/27/2001 Lethargy. 10/28/2001 and 10/29/2001 Emotional lability. Y 10/26/2001 10/27/2001 1 NONE OTH OTH Metferma XR, Alcutrol, Premarin, Foshpril, Zoloft, Simvastatin and Asprin. NONE DM2, Allergeis:Cephradine, cephalexia, ATN, Optic nerve diusen. 1
0177396 11/08/2001 MO 60.0 60 F 11/06/2001 Reaction started around 4 hrs after injection. Symptoms include dryness, edema, erythema of left deltoid arm. States seemed to be improving by the next day. Y 11/05/2001 11/05/2001 0 NONE PUB PVT Duratuss, Prilosec, Premarin Allergy to sulfa and some antibiotics 1
0177397 11/08/2001 MN 1.0 1 .3 F MMR on 10/12/2001. 10/25/2001 cough, rhinrhea and 3 by 5 cm cluster of macules right lower quadrant abdomen and 99.5 fever. No oral lesions. N 10/12/2001 10/25/2001 13 PVT PVT 1
0177398 11/08/2001 NC 1.9 2 1 F 10/23/2001 Swelling, redness, erythema, 3x3 cm with induration, non tender, no systemic reaction. No signs of cellulitis, stable vital signs. Treated symptomatic, follow-up the next day. Y 10/03/2001 10/10/2001 7 PVT PVT NONE NONE 1
0177399 11/08/2001 NC 1.0 1 .1 M 10/31/2001 Vomiting times 1, swelling of upper eyelids, restlessness and erythematous rashes on cheeks. Y Y 10/30/2001 10/30/2001 0 PUB PVT NONE NONE 1
0177400 11/08/2001 GA 0.3 0 .2 M 10/19/2001 07/30/2001 approximately 3 hours after immunization, pt had persistent crying, low-grade fever, green mucous stools. On 08/02/2001, went to MD with red rash on trunk of body with previous symptoms continuing. Given Tylenol with codeine, resolved on 08/05/2001. Y Y 07/30/2001 07/30/2001 0 PUB PVT GA01090 1
0177401 11/08/2001 GA 0.4 0 .5 F 07/06/2001 Macular rash on neck, face and digit faint redness of trunk and limbs, mother giving Tylenol advise discontinue and discontinue new foods stated this week. N 07/03/2001 07/04/2001 1 PUB PUB NONE NONE NONE GA01093 1
0177402 11/08/2001 62.0 M 09/12/2000 Describes peripheral neuropathy in 62 year old male receiving Re Quip for the treatment of Parkinson's disease. the vaccine developed "intermititant twinges in legs" and his "ankles were sensitive to touch." In April 2000, he developed "numbness" in his feet and pain (NOS) in his legs. Y Y 07/01/1999 12/01/1999 153 UNK UNK Sinemet, Eldephyl, Arcane, Viagra. Acetylsalicylic Acid, Vitamin E Parkinson's Disease Peripheral Neuropathy, Parkinson's Disease 20000217042 1
0177403 11/08/2001 OH F Marked swelling of left arm with pain and redness at site of vaccine immunization on left deltoid. Y 04/17/2001 04/17/2001 0 PUB OTH Alendronate 1
0177404 11/08/2001 GA 23.0 23 F 09/11/2001 Within 60 seconds after MMR vaccine, pt dropped paper on floor and pt head leaned backwards against leaver of chair. No response to verbal stimuli. Ammonium was administered below nose and pt responded in 60 seconds, becoming alert and able to speak. Urine noted on seat. On 9/12/01, TC to client, states "OK"! had not eaten, before shot, was nervous. Y 09/11/2001 09/11/2001 0 PUB PUB NONE NONE NONE GA01097 1
0177405 11/08/2001 GA 23.0 23 F 10/09/2001 10/06/2001, 1500 hrs PM, first notice "Bee sting" size area on left arm. It continued to get redder and larger and very sore by that evening, saw doctor on 10/08/2001 given Antibiotics. Y U 10/05/2001 10/06/2001 1 PUB PUB Prilosec GA01098 1
0177406 11/08/2001 GA 1.0 1 .3 F 08/20/2001 Swelling that covered the entire left knee. Child was taken to MD by the grandmother. Y Y 08/15/2001 08/15/2001 0 NONE PUB PUB NONE NONE NONE GA01096 1
0177407 11/08/2001 GA 4.0 4 M 08/06/2001 Temp 99.5 this AM. Treated with Tylenol several days after immunization. Right leg swollen with knot and returned. Mother stated was larger this AM and it has gone down some now. Right upper thigh hot red area 3cm by 5cm and knot 3 cm by 1.5 cm other was okay now. Y 08/02/2001 08/04/2001 2 PUB PUB NONE NONE NONE GA01094 1
0177408 11/08/2001 GA 13.0 13 F 08/08/2001 Pt collapsed with related motor twitching, approximately 5 minutes after hep B administration (3rd injcetion). Recover with fan and cold compress, complained of nausea. Soda given and advised to eat high protein sandwich (peanut butter). Recommend seeing pediatrician. Y 08/08/2001 08/08/2001 0 BP 88/50 PUB PUB NONE UNK motor twitching~Hep B (no brand name)~2~10.00~In Patient GA01095 1
0177409 11/08/2001 GA 5.0 5 M 10/02/2001 Aunt here today. States child broke out in rash day after shots on 09/17/2001. Rash covered neck and back. No fever. Did not see doctor or ER. No breathing difficulty Rash still there. Y 09/17/2001 09/18/2001 1 PUB PUB UNK NONE NONE GA01088 1
0177410 11/08/2001 TN 7.0 7 M 11/02/2001 Localized rash to right deltoid. No treatment necessary. Y Y 10/26/2001 10/31/2001 5 NONE PUB PVT NONE NONE Autism ~Measles + Mumps + Rubella (no brand name)~1~6.00~In Sibling 1
0177411 11/08/2001 GA 6.0 6 F 10/30/2001 According to mother, after receiving shot yesterday afternoon, child broke out in a red rash on face and legs and began to itch. Was treated at home with Vistaril. Denies any symptoms today, 10/30/2001. Also treated with Tagamet and Zyrtec. The 4 X that she received in the past without allergy or allergic reaction. Y 10/29/2001 10/29/2001 0 PUB PUB NONE NONE PCN allergy and inhalation asthma GA01100 1
0177412 11/08/2001 MN 18.0 18 F 10/30/2001 Two hours after vaccine administered, pt experienced severe left lower quadrant pain/cramping a 7 on a scale of 1-10 with 10 being the worst pain. Pain lasted 1 hour, pt laid down, fell asleep. Y 09/25/2001 09/25/2001 0 PUB PUB Slight abdominal cramping for 2 months, not at this time. Slight abdominal cramping for 2 months, intermittent. 1
0177413 11/08/2001 PA 4.0 4 M 11/02/2001 Elevated fever with hallucinations and episode of increased topical reaction (swelling, erythema); pt unable to move arm (left arm). On 11/2/01, improved. Y 10/30/2001 10/30/2001 0 PVT PUB 1
0177414 11/08/2001 IN 0 .9 F 11/02/2001 Has clinical chicken pox on 11/02/2001. 05/17/1995 11/01/2001 2360 PVT PVT Developmental delay 1
0177415 11/08/2001 DC 0.08 0 .1 M 11/05/2001 PM of 11/02/2001 lethargy, couldn't stay awake to nurse more than 1 minute at a time. Lasted through 11/03/3001 saw MD 11/03/2001 nursed well in office. Y Y 11/02/2001 11/02/2001 0 PVT PVT NONE NONE 1
0177416 11/08/2001 NM 5.0 5 F 10/31/2001 Thigh red, small area of bruising minimum if any tender, 8 cm in diameter. U 10/25/2001 10/27/2001 2 OTH OTH NONE 1
0177417 11/08/2001 MI 16.0 16 M 10/30/2001 Pt's father check out increased irritability. Not responding to redirection physical aggression, agitation started 15 hours after dose. No treatment. Being seen by psychiatrist. N 10/26/2001 10/27/2001 1 PUB PUB Depakote 750 mg bid po Benadryl and tsp at bedtime each day. NONE Downs Syndrome - Atrial Ventricella Septal Defect. 1
0177418 11/08/2001 TX 12.0 12 M 05/24/2001 Tonic clonic seizures lasting 8-10 minutes (Status Epiletius). Treated with Dilantin 1100 mg IV, KCl elixir 20 mg eq po, Valium 5 mg IM, left hip, Valium 5 mg IM right hip, Valium 10 mg IV, Valium 5 mg IV, Tylenol 650 mg supp, KU 20 mEg IV at 50 cc 1 hr; Transferred to Lubbock Univ Med Ctr. Y Y 05/01/2001 05/02/2001 1 CBC, BMP, Ca Lt, Mg Lt PVT OTH Dilantin Susp, Motrin/Tylenol Allergy to Rondec, Cerebral Palsy, Seizures. 1
0177419 11/08/2001 9.0 9 F 10/19/2001 Had Hepatitis B vaccine left deltoid. Shortly after child got home developed rash around waist, chest and thighs areas. Had scratching in throat and headache. No respiratory difficulty. 07/12/2001 07/12/2001 0 OTH OTH 1
0177420 11/08/2001 IL 66.0 66 F 11/01/2001 Localized allergic reaction 6-7 cm diameter of erythema and heat at injection site right deltoid. Treatment: ice, hold physical therapy, Medrol dose pack. 10/30/2001 10/31/2001 1 PVT UNK NONE Pneumovax local reaction, macrodontin septra local reaction~Pneumo (Pneumovax)~~0.00~In Patient 1
0177421 11/08/2001 MN 43.0 43 F 11/07/2001 Site of injection swelled to size of 1/2 of golf ball. red spot 3 inch in diameter appeared. Spot was very hot to touch. Arm from elbow to shoulder became tender to touch (day two) under arm from elbow to arm pit became swollen and tender to touch. Pain lasted 36 hours. Y 11/02/2001 11/03/2001 1 PVT PVT Noxanase and birth control pills NONE Allergic to spermacide, NSAID's and asprin 1
0177422 11/08/2001 LA 0.48 0 .5 M 11/05/2001 Comvax given 10/29/2001 - IM, left thigh. Mom reports on 11/02/2001 - red area with hard knot, pt seen in clinic on 11/02/2001 by Dr. Y 10/29/2001 10/30/2001 1 OTH OTH NONE 1
0177423 11/08/2001 GA 3.0 3 F 09/19/2001 09/18/2001, 8:30 PM fever last night gave Tylenal, 09/19/2001, 12:00 noon reticad redness, swelling, warmth to RDT, No check out pain from child, 09/19/2001, 13:15 PM, temp 98.4, gave Benadryl 12.5 mg. By mouth and Tylenol 1 tsp by mouth per Dr. Cold compress applied. Y 09/17/2001 09/18/2001 1 PUB PUB NONE Fifth's disease with no fever. NONE GA01085 1
0177424 11/08/2001 MI 80.0 80 F 10/11/2001 Red and swollen area on right arm, 3x5 inches surrounding injection site of Pneumovax, nausea and general malaise. Pt started Cipro 250 BID for VTL on 10/08/2001. Y 10/09/2001 10/09/2001 0 PVT PVT Cipro 250 BID, Tenormin, Prevacid, Synthroid, Dyazide, Accupril, Premarin. Urinary Tract Infection. Htn, Hypothyroidism, Pernicious Ammonia. 1
0177425 11/08/2001 RI 1.3 1 .1 M 10/31/2001 2 1/2 - 3" raised erythematous area on left thigh. 2 immunization given in area. Y Y 10/30/2001 10/30/2001 0 PUB PUB NONE NONE 1
0177426 11/08/2001 GA 5.0 5 F 10/10/2001 Began Saturday PM/Sunday AM Mom noted beginning discoloration from waist to toes during routine check of child. Color deepened to dark red/blue splotches during the day. Two AM on 10/07/2001 was Med Center from 9pm -2:30am with IV's to keep veins open for Venus lab work. Complaining of stomach ache and vomited. Given Bactrium for blood in urine (?UTI). Tuesday rash turning light brown. Note: saw MD in office Monday, took off Bactrium returned to Clinic two weeks. Y Y 10/04/2001 10/07/2001 3 HSP PUB PUB NONE NONE NONE ~Vaccine not specified (no brand name)~~1.00~In Sibling GA01089 1
0177428 11/09/2001 PA 40.0 40 F 03/14/2001 It was reported that an adult female pt received a Fluzone SV '00-'01 vaccination (lot number not provided) on 20 Dec 2000. Reportedly within ten minutes of receiving vaccination the pt experienced a systemic reaction consisting of throat closing, face swelling and shortness of breath. Y 12/20/2000 12/20/2000 0 PVT UNK Patient has had flu vaccine (manufacturer unknown)broke out in hives. Benadryl U2001002500 1
0177429 11/09/2001 PA F 08/01/2000 It was reported that a female pt received a Fluzone unspecified vaccination sometime in 1998. reportedly the pt claims she has experienced left side weakness since 1998. No specifics provided. Further information requested. U UNK UNK 02000005910 1
0177430 11/09/2001 CT F 08/10/2000 After receiving a vaccination, on 10/07/1999, the patient experienced persistent proximal shoulder and thigh pain similar to polymyalgia rheumatica. The patient was responsive to Prednisone greater than or equal to 10mg every day, but normal erythrocyte sedimentation rate 2 wks after the vaccination. Y N 09/22/1999 10/07/1999 15 Bone scan, x-ray, MRI, LABS all unremarkable. PVT OTH NONE 02000006030 1
0177431 11/09/2001 CA 64.0 F 11/06/2000 It was reported that a 64 yr old female pt rec'd a flu vaccination on 11/15/99. Reportedly that same day the pt developed GI upset, cramps, diarrhea and weakness to the point of feeling faint. Pt was treated with IV fluids at the hospital and released. Gastroenterologist evaluated pt. Sigmoidoscopy was normal with small hemorrhoidal bleeding. Pt was informed by hospital staff these reactions were not related to the flu vaccine. Y U 11/15/1999 11/15/1999 0 Sigmoidoscopy normal with small hemorrhoidal bleeding. OTH OTH U2000007940 1
0177432 11/09/2001 NV 46.0 46 F 11/22/2000 It was reported that a 46 year old female pt received a Fluzone SV '00-'01 vaccination on 9/22/00 at 08:00 as well as having blood drawn in the same arm. The pt contacted the Center to say that her hand was swelling and the injection site was sore. The pt was referred to her physician. Reportedly, the pt recovered from this experience. Received correspondence on 2/1/01 stating "nothing more to add". Y Y 09/22/2000 09/22/2000 0 NONE PUB OTH NONE UNK U2000008480 1
0177433 11/09/2001 U 01/17/2001 It was reported that a pt (1 of 5) received a Fluzone SV '00-'01 vaccination. Reportedly, sometime after the vaccination, the pt developed a local reaction of redness and warmth. No specifics provided, further information is requested. U OTH OTH U2001000790 1
0177434 11/09/2001 U 01/17/2001 It was reported that a pt (2 of 5) received a Fluzone SV '00-'01 vaccination. Reportedly sometime after the vaccination the pt developed a local reaction of redness and warmth. No specifics provided, further information is requested. UNK UNK U200100080 1
0177435 11/09/2001 U 01/17/2001 It was reported that a pt (3 of 5) received a Fluzone SV 'oo - "01 vaccination. Reportedly sometime after the vaccination the pt developed a local reaction of redness and warmth. No specifics provided, further information is requested. UNK UNK U200100081 1
0177436 11/09/2001 U 01/17/2001 It was reported that a pt (4 of 5) received a Fluzone SV '00 - '0 vaccination. Reportedly sometime after the vaccination the pt developed a local reaction of redness and warmth. No specifics provided, further information is requested. UNK UNK U200100082 1
0177437 11/09/2001 U 01/17/2001 It was reported that a pt (5 of 5) received a Fluzone SV '00 - '0 vaccination. Reportedly sometime after the vaccination the pt developed a local reaction of redness and warmth. No specifics provided, further information is requested. UNK UNK U200100083 1
0177438 11/09/2001 CA U 01/17/2001 It was reported that a pt (1 of 10) received a Fluzone SV '00-'01 on 9 Oct 2000. Reportedly within 48-72 hours post vaccination the pt complained of pain, redness, swelling and induration at the injection site. No specific provided, further information requested. U 10/09/2000 UNK UNK U200100084 1
0177439 11/09/2001 CA U 01/17/2001 It was reported that a pt (2 of 10) received a Fluzone SV '00-'01 on 10/9/00. Reportedly, within 48-72 hours, post vax, the pt complained of pain, redness, swelling and induration at the injection site. No specifics provided; further information requested. U 10/09/2000 UNK UNK U2001000850 1
0177440 11/09/2001 CA U 01/17/2001 It was reported that a pt (3 of 10) received a Fluzone SV '00-'01 on 10/9/00. Reportedly, within 48-72 hours, post vax, the pt complained of pain, redness, swelling and induration at the injection site. No specifics provided, further information requested. U 10/09/2000 OTH OTH U2001000860 1
0177441 11/09/2001 CA U 01/17/2001 It was reported that a pt (4 of 10) received a Fluzone SV '00-'01 on 10/9/00. Reportedly, within 48-72 hours, post vax, the pt complained of pain, redness, swelling and induration at the injection site. No specifics provided; further information requested. U 10/09/2000 OTH OTH U2001000870 1
0177442 11/09/2001 CA U 01/17/2001 It was reported that a pt (5 of 10) received a Fluzone SV '00-'01 on 10/9/00. Reportedly, within 48-72 hours, post vax, the pt complained of pain, redness, swelling and induration at the injection site. No specifics provided; further information requested. U 10/09/2000 OTH OTH U2001000880 1
0177443 11/09/2001 CA U 01/17/2001 It was reported that a pt (6 of 10) received a Fluzone SV '00-'01 on 10/9/00. Reportedly, within 48-72 hours, post vax, the pt complained of pain, redness, swelling and induration at the injection site. No specifics provided; further information requested. U 10/09/2000 OTH OTH U2001000890 1
0177444 11/09/2001 CA U 01/17/2001 It was reported that a pt (7 of 10) received a Fluzone SV '00-'01 on 10/9/00. Reportedly, within 48-72 hours, post vax, the pt complained of pain, redness, swelling and induration at the injection site. No specifics provided; further information requested. U 10/09/2000 OTH OTH U2001000900 1
0177445 11/09/2001 CA U 01/17/2001 It was reported that a pt (8 of 10) received a Fluzone SV '00-'01 on 9 Oct 2000. Reportedly within 48 - 72 hours post vaccination the pt complained of pain, redness, swelling and induration at the injection site. No specific provided, further information requested. U 10/09/2000 Injection site reaction. UNK UNK U200100091 1
0177446 11/09/2001 CA U 01/17/2001 It was reported that a pt (9 of 10) received a Fluzone SV '00-'01 on 9 Oct 2000. Reportedly within 48-72 hours post vaccination the pt complained of pain, redness, swelling and induration at the injection site. No specifics provided, further information requested. U 10/09/2000 UNK UNK U200100092 1
0177447 11/09/2001 CA U 01/17/2001 It was reported that a pt (10 of 10) received a Fluzone SV '00-'01 on 9 Oct 2000. Reportedly within 48-72 hours post vaccination the pt complained of pain, redness, swelling and induration at the injection site. No specifics provided, further information requested. U 10/09/2000 UNK UNK U2001000930 1
0177448 11/09/2001 MO 34.0 34 F 03/14/2001 It was reported that a female pt received a Fluzone SV '00-'01 vaccination in the gluteal area on 11 Oct 2000. Reportedly 12 Oct 2000 the pt developed a local reaction of redness and swelling. Further information requested. Pt received the Flu-vaccine in the hip. Y 10/11/2000 10/12/2000 1 UNK UNK Humulin, insulin slide scale IDDM U2001000940 1
0177449 11/09/2001 ID 51.0 51 M 02/14/2001 It was reported that a 51-year old male patient received a Fluzone SV '00-'01 vaccination on 16 Oct 2000 at 10 am. At 2 pm the patient developed pain in arm, extremities and pelvic area along with fatigue. At 6 pm the pt developed shaking, chills, malaise and was achy. Pt slept from 9pm to morning the symptoms were gone. The pt recovered from the experience. No additional information was provided from correspondence received on 7 Feb 2001. No further information is expected. This case is closed. Y 10/16/2000 10/16/2000 0 OTH OTH pain, asthenia, chills, malaise. NONE U200100099 1
0177450 11/09/2001 TN U 01/18/2001 It was reported that a pt (1 of 13) received a Fluzone SV '00-'01 vaccination on 17Oct2000. Reportedly sometime after the vaccination the pt developed a local reaction. No specifics were provided. Further information is requested. U 10/17/2000 UNK UNK U200100101 1
0177451 11/09/2001 TN U 01/18/2001 It was reported that a pt (2 of 13) received a Fluzone SV '00-'01 vaccination on 17Oct2000. Reportedly sometime after the vaccination the pt developed a local reaction. No specifics were provided. Further information is requested. U 10/17/2000 UNK UNK U200100102 1
0177452 11/09/2001 TN U 01/18/2001 It was reported that a pt (3 of 13) received a Fluzone SV '01-'02 vaccination on 10/17/00. Reportedly, sometime after the vaccination, the pt developed a local reaction. No specifics were provided. Further information is requested. U 10/17/2000 UNK UNK U200100103 1
0177453 11/09/2001 TN U 01/18/2001 It was reported that a pt (4 of 13) received a Fluzone SV '00-'01 vaccination on 17 Oct 2000. Reportedly sometime after the vaccination the pt developed a local reaction. No specifics were provided. Further information is requested. U 10/17/2000 Injection site reaction. UNK UNK U200100104 1
0177454 11/09/2001 TN U 01/18/2001 It was reported that a pt (5 of 13) received a Fluzone SV '00-'01 vaccination on 17 Oct 2000. Reportedly sometime after the vaccination the pt developed a local reaction. No specifics were provided. Further information is requested. U 10/17/2000 UNK UNK U200100105 1
0177455 11/09/2001 TN U 01/18/2001 It was reported that a pt (6 of 13) received a Fluzone SV '00-'01 vaccination on 17 Oct 2000. reportedly sometime after the vaccination the pt develope a local reaction. No specifics were provided. Further information is requested. U 10/17/2000 UNK UNK U200100106 1
0177456 11/09/2001 TN U 01/18/2001 It was reported that a pt (7 of 13) received a Fluzone SV '00-'01 vaccination on 17 Oct 2000. Reportedly sometime after the vaccination the pt developed a local reaction. No specifics were provided. Further information is requested. U 10/17/2000 UNK UNK U200100107 1
0177457 11/09/2001 U 01/18/2001 It was reported that a pt (8 of 13) received a Fluzone SV '00-'01 vaccination on 17 Oct 2000. Reportedly sometime after the vaccination the pt developed a local reaction. No specifics were provided. Further information is requested.l U 10/17/2000 UNK UNK U200100108 1
0177458 11/09/2001 TN U 01/18/2001 It was reported that a pt (9 of 13) received a Fluzone SV 2000-2001 vaccination on 10/17/2000. Reportedly sometime after the vaccination the pt developed a local reaction. No specifics were provided. Further information is requested. U 10/17/2000 OTH OTH U2001001090 1
0177459 11/09/2001 TN U 01/18/2001 It was reported that a pt (10 of 13) received a Fluzone SV '00-'01 vaccination on 17 Oct 2000. Reportedly sometime after the vaccination the pt developed a local reaction. No specifics were provided. Further information is requested. U 10/17/2000 UNK UNK U2001001100 1
0177460 11/09/2001 TN U 01/18/2001 It was reported that a pt (11 of 13) received a Fluzone SV '00-'01 vaccination on 17 Oct 2000. Reportedly sometime after the vaccination the patient developed a local reaction. No specifics were provided. Further information is requested. U 10/17/2000 UNK UNK U200100111 1
0177461 11/09/2001 TN U 01/18/2001 It was reported that a patient (12 of 13) received a Fluzone SV '00-'01 vaccination on 17 Oct 2000. Reportedly sometime after the vaccination the patient developed a local reaction. No specifics were provided. Further information is requested. U 10/17/2000 UNK UNK U200100112 1
0177462 11/09/2001 TN U 01/18/2001 It was reported that a pt (13 of 13) received a Fluzone SV 2000-2001 vaccination on 10/17/2000. Reportedly sometime after the vaccination the pt developed a local reaction. No specifics were provided. Further information is requested. U 10/17/2000 OTH OTH U2001001130 1
0177463 11/09/2001 CA 30.0 F 01/18/2001 It was reported that a 30 year old woman was vaccinated with a Fluzone SV '00-'01 vaccination on 13 Oct 2000. Reportedly the same day the patient experienced local pain, burning, and a red, itching rash from the shoulder to elbow. On 17 Oct 2000, the pt was starting to improve. Further info is being requested. From add. info received 01 Feb 2001, pt has recovered. Y 10/13/2000 10/13/2000 0 PVT PVT U200100115 1
0177464 11/09/2001 CA 45.0 F 02/12/2001 It was reported that a pt received Fluzone SV 2000-2001 vaccination on 10/13/2000. Reportedly on 10/14/2000 the pt experienced itching, rash and pain at the injection site. She also experienced internal itching in abdomen and a stomach ache which lasted for three days. Further information is being requested. From additional correspondence received on 02/01/2001, it was reported that the pt recovered from this experience. Y 10/13/2000 10/14/2000 1 PVT PVT U2001001210 1
0177465 11/09/2001 FL F 03/20/2001 It was reported that a pt (1 of 4) received a Fluzone 2000-2001 vaccination, given IM on 10/19/2000. Reportedly the pt developed numbness and tingling in the arm and hand after the injection. No specifics were provided. Further information is being requested. From additional correspondence received on 03/16/2001, it was reported, mild, short duration relived with ice application. Reportedly the pt recovered from this experience. Y 10/19/2000 10/19/2000 0 OTH OTH U2001001240 1
0177466 11/09/2001 FL F 03/20/2001 It was reported that a pt (2 of 4) received a Fluzone 2000-2001 vaccination, given IM on 10/19/2000. Reportedly the pt developed numbness and tingling in the arm and hand after the injection. No specifics were provided. Further information is being requested. From additional correspondence received on 03/16/2001 it was reported, given follow-up by employer and is discharged from further intervention. Reportedly the pt recovered from this experience no residue. Y Y 10/19/2000 10/19/2000 0 OTH OTH U2001001260 1
0177467 11/09/2001 FL F 03/20/2001 It was reported that a pt (3 of 4) received a Fluzone 2000-2001 vaccination, given IM on 10/19/2000. Reportedly the pt developed numbness and tingling in the arm and hand after the injection. No specifics were provided. Further information is being requested. From additional correspondence received on 03/16/2001, it was reported mild relieved with ice packs. The pt reportedly recovered from this experience. Additional responsible facility, vaccine and pt information was provided. Y 10/19/2000 10/19/2000 0 OTH OTH U2001001270 1
0177468 11/09/2001 FL F 03/20/2001 It was reported that a patient (4 of 4) received a Fluzone '00-'01 vaccination, given IM on 19 Oct 2000. Reportedly the patient developed numbness and tingling in the arm and hand after the injection. No specifics were provided. Further information is being requested. For additional correspondence received on 16 March 2001, it was reported, "mild relieved with ice packs." The pt reportedly recovered from this experience. Additional responsible facility, vaccine, and pt information was provided. Y 10/19/2000 10/19/2000 0 OTH OTH U200100128 1
0177469 11/09/2001 FL 55.0 55 F 02/12/2001 It was reported that a female pt received a Fluzone SV 2000-2001 vaccination on 10/23/2000. Reportedly that same day the pt experienced hives and itching which were treated with antihistamines. The experience is resolving. Further information is being requested. From additional correspondence received on 02/02/2001, it was reported that the pt recovered from this experience. Additional vaccine pt and reporter information was also provided. Y 10/23/2000 10/23/2000 0 PUB PUB Phenolpthelin U2001001320 1
0177470 11/09/2001 PA 46.0 46 F 02/14/2001 It was reported that a pt received a Fluzone SV 2000-2001 vaccination on 10/23/2000. Reportedly that same day the pt experienced redness and swelling at the injection site, dizziness, nausea and fainting. She was sent to the ER. No specifics were provided. Further information is being requested. From additional correspondence received on 02/07/2001 additional pt, vaccine administrator and responsible physician information was provided. No further information is expected for this case. Case is closed. Y U 10/23/2000 10/23/2000 0 PVT PVT NONE Hypothyroidism, DTD, HTN, Lupus U2001001360 1
0177471 11/09/2001 PA 41.0 40 F 02/14/2001 Edema Nausea Dizziness Sweating Injection Site Reaction It was reported that a 41-year-old woman received a Fluzone SV '00-'01 vaccination on 23-Oct-2000. Reportedly, fifteen minutes after the vaccination the patient experienced redness and swelling at the injection site, dizziness, nausea and cool and clammy skin. The patient laid down for twenty minutes and the symptoms subsided. Further information is being requested. From additional correspondence received on 7-Feb-2001, it was reported that the patient recovered from this experience. Additional patient, vaccine administrator and responsible physician information was also provided. No further information is expected for this case. Case is closed. Y 10/23/2000 10/23/2000 0 PVT UNK None Hypercholestemia, Renal Calculi, Seizure disorder,Migraine Ha 1
0177475 11/09/2001 MI 15.0 15 M 01/18/2001 It was reported that a pt received a Fluzone SV 2000-2001 vaccination on 10/26/2000. Reportedly the pt developed a local reaction within 24 hours of vaccination consisting of injection site warmth, redness and bruise. Further information is requested. U 10/26/2000 10/27/2000 1 OTH OTH U2001001430 1
0177476 11/09/2001 SC M 01/18/2001 It was reported that a male pt received a Fluzone SV '00-'01 vaccination on 30 Oct 2000. Reportedly the pt developed urticaria 4 hours after injection and was managed with Benadryl. Further information is requested. U 10/30/2000 10/30/2000 0 UNK UNK 02001001490 1
0177477 11/09/2001 ID 37.0 37 F 02/14/2001 It was reported that a pt received a Fluzone SV 2000-2001 vaccination on 10/31/2000. Reportedly 24 hours after injection the pt developed a local reaction. Four days later developed itching at injection site. Further information is requested. From additional correspondence received on 02/07/2001, it was reported that the pt recovered from this experience. Additional pt, vaccine administrator and responsible physician information was also provided. Y 10/31/2000 11/01/2000 1 NONE PVT PVT Erythema left deltoid NONE U2001001500 1
0177478 11/09/2001 OK 66.0 66 M 02/16/2001 It was reported that a male pt received a Fluzone SV '00-'01 vaccination 25 Oct 2000. Reportedly that same day the patient complained of soreness and numbness with elevation of arm at injection site. Further information is requested. U 10/25/2000 10/25/2000 0 PVT PVT U200100151 1
0177479 11/09/2001 IL U 01/18/2001 It was reported that a patient (1 of 2) received a Fluzone SV '00-'01 vaccination. Sometime after the injection the patient complained of induration, swelling and redness and injection site. Further information is requested. UNK UNK 02001001520 1
0177480 11/09/2001 IL U 01/18/2001 It was reported that a patient (2 of 2) received a Fluzone SV '00-'01 vaccination. Sometime after the injection the patient complained of induration, swelling and redness and injection site. Further information is requested. U UNK UNK 02001001530 1
0177481 11/09/2001 UT 38.0 38 F 03/14/2001 It was reported that a female patient received a Fluzone SV'00-'01 vaccination on 6 Nov 2000. Approximately 5 hours after vaccination the patient developed ulcers in her mouth and swelling of her tongue, no respiratory distress and pain in her jaw. Further information is requested. From additional correspondence received on 8 Mar 2001, it was reported that the pt experienced pain when attempting to open her mouth. The pt reportedly recovered from this experience with no sequelae. Add. pt, lab data and responsible physician information were also provided. Y Y 11/06/2000 11/06/2000 0 PVT PVT NONE Medicine allergies U200100154 1
0177482 11/09/2001 IL 48 F 01/18/2001 It was reported that a female patient received a Fluzone SV '00-'01 vaccination on 28 Oct 2000. Reportedly the pt developed pain the same evening as dose was administered and described as "grabbing" pain. Turned into severe pain to where she was incapacitated. Soreness in chest from back spasms. Hurts to take a breath. Residual ache and back soreness on left, which was vaccine, site. Pt has had fibromyalgia for 15 yrs and this is not that kind of pain. Y 10/28/2000 10/28/2000 0 UNK UNK Naprosyn, Medrolpack U200100155 1
0177485 11/09/2001 PA 31.0 31 F 01/19/2001 One day post vax, pt complained of redness approximately 1 3/4", swelling, itching and pain at site of injection. On 11/9/00, the swelling decreased but the redness increased approximately .5". The pt complained of headache, increase of itching and pain. Further info is requested. U 11/06/2000 11/07/2000 1 OTH OTH U2001001580 1
0177486 11/09/2001 PA 52 F 01/20/2001 Sometime post vax (date not specified) pt complained of redness and swelling at the site of injection. Further info is requested. U 10/01/2000 OTH OTH U2001001590 1
0177487 11/09/2001 MA 71.0 71 F 02/15/2001 Pt developed a large local reaction immediately post vax. No specifics were provided. From further correspondence recvd 2/8/01. it was reported that the pt has not recovered from this experience. Further info is requested. N 11/08/2000 11/08/2000 0 PUB OTH NONE U2001001650 1
0177488 11/09/2001 MA 19.0 19 F 03/09/2001 On 11/12/00, pt developed paresthesia of the right arm and leg. Pt was evaluated at college facility. MD felt symptoms were self-eliminating. Addtl info recvd 2/23/01 reported that the pt recovered from this experience. No further info is anticipated. This case is closed. Y Y 11/09/2000 11/12/2000 3 OTH OTH NONE NONE U2001001660 1
0177489 11/09/2001 CA 55.0 55 M 01/20/2001 It was reported that a male patient received a Fluzone SV vaccination on 10/23/2000. Reportedly 2 days after the injection, the patient developed a persistent tingling sensation from the injection site to his fingers. Further information is requested. U 10/23/2000 10/25/2000 2 UNK UNK U200100167 1
0177490 11/09/2001 WI 27.0 26 M 01/20/2001 It was reported that a 27 year old male patient received a Fluzone SV vaccination on 11/14/2000. Reportedly that same day the patient complained of severe pain in the area of an hiatal hernia. Further information is requested. U 11/14/2000 11/14/2000 0 UNK UNK Hiatal hernia U200100168 1
0177491 11/09/2001 IA 82.0 82 F 02/12/2001 It was reported that an 82 year old female patient received a Fluzone SV vaccination on 11/14/2000. Reportedly later that day the patient's face and tongue were swollen, no respiratory distress. Further information is requested. From correspondence received on 02/02/2001 it was reported that the patient recovered from this experience. Additional patient, vaccine and the responsible physician and vaccine administator information were also provided. Y Y 11/14/2000 11/14/2000 0 PUB PVT NONE U200101690 1
0177492 11/09/2001 PA 47.0 47 F 01/21/2001 It was reported that a 47 year old female patient received a Fluzone SV vaccination on 11/15/2000. Reportedly on 11/16/2000, the patient complained of redness, swelling, itching and warmth at the site of injection. The vaccine was administered in the upper arm, below the deltoid. U 11/15/2000 11/16/2000 1 UNK UNK U200100170 1
0177493 11/09/2001 NC 52.0 52 F 01/21/2001 It was reported that a 52 year old female patient received a Fluzone SV vaccination on 11/15/2000. Reportedly 3-4 hours after the injection the patient developed a feeling in her throat (type of feeling not specified) and difficulty swallowing. There was no respiratory distress. These symptoms completely subsided in 12 hours. Y 11/15/2000 11/15/2000 0 UNK UNK U200100171 1
0177494 11/09/2001 MO 51.0 51 F 01/21/2001 It was reported that a 51 year old female patient received a Fluzone SV vaccination on 10/13/2000 at a hospital clinic. The patient developed hives with itching at the waist on 10/15/2000. The hives spread over her entire body. The patient went to the ER and was treated with Prednisone four times. The hives are now gone but the patient is still experiencing itching on her hands, feet and inner elbow areas. Y U 10/13/2000 10/15/2000 2 UNK UNK Mastectomy 4.5 years ago. U200100172 1
0177495 11/09/2001 OH 59.0 59 F 01/21/2001 It was reported that a female patient received a Fluzone SV vaccination on 11/10/2000. Reportedly within the next day or two the patient developed swollen lymph glands under her arms. Further information is requested. U 11/10/2000 11/11/2000 1 UNK UNK U200100173 1
0177496 11/09/2001 WI 48.0 48 F 03/08/2001 It was reported that a 48 year old female received a Fluzone SV vaccination on 11/07/2000. Approximately 2 weeks after the injection, the patient developed brachial plexus neuropathy, painful with movement. Further information is requested. From additional correspondence received on 02/21/2001, it was reported that the patient recovered from this experience. Additional patient, vaccine administrator and responsible physician information was also provided. Y 11/07/2000 11/21/2000 14 NONE UNK UNK NONE NONE U200100174 1
0177497 11/09/2001 NJ 48.0 48 F 03/09/2001 It was reported that a female patient received a Fluzone SV vaccination on 11/10/2000. Within 18 hours of vaccination the patient developed Bell's Palsy to the left side of her face. The patient was treated in the ER and released. From additional correspondence received on 02/22/2001, it was reported that the patient recovered from this experience. Additional patient, vaccine administrator and responsible physician information were also provided. No further information is anticipated. This case is closed. Y Y 11/10/2000 11/11/2000 1 PVT OTH U200100178 1
0177498 11/09/2001 CA 38.0 F 01/21/2001 It was reported that a female patient received a Fluzone SV vaccination on 11/20/2000. Approximately 24 hours after the vaccination, the patient developed a red area at the injection site. U 11/20/2000 11/21/2000 1 UNK UNK U200100179 1
0177499 11/09/2001 PA 68.0 68 M 03/10/2001 It was reported that a male patient in his 40's received a Fluzone SV vaccination on 11/15/2000. Reportedly within 24 hours, the patient had flu-like symptoms and fever blisters on his lip and the septum of his nose. The symptoms resolved in a few days. From additional correspondence received on 02/28/2001, additional patient, vaccine administrator and responsible physician information were provided. No further information is anticipated. This case is closed. Y 11/15/2000 11/17/2000 2 PVT UNK NONE U200100182 1
0177500 11/09/2001 OH 55.0 55 F 01/22/2001 It was reported that a 55 year old female patient received a Fluzone SV vaccination on 11/28/2000. Reportedly that same day, the patient complained of a rash on her neck and torso. Further information is requested. U 11/28/2000 11/28/2000 0 UNK UNK U200100183 1
0177501 11/09/2001 FL F 03/15/2001 It was reported that a patient (1 of 4) received a Fluzone SV vaccination on 11/30/2000. Reportedly the patient developed local redness within 1 hour of the injection. No specifics were provided. Further information is requested. From additional correspondence received 03/13/2001, it was reported that the patient recovered from this experience. Additional patient, vaccine, correct adverse event onset dates, vaccine administrator and responsible physician information were also provided. Y 11/30/2000 11/30/2000 0 PVT PVT NONE NONE U200100184 1
0177502 11/09/2001 FL U 03/15/2001 It was reported that a patient (2 of 4) received a Fluzone SV vaccination on 11/28/2000. Reportedly the patient developed local redness within 1 hour of the injection. No specifics were provided. Further information is requested. No further information was provided from correspondence returned on 03/13/2001. U 11/28/2000 11/28/2000 0 UNK UNK U200100185 1
0177503 11/09/2001 FL 34.0 34 F 03/15/2001 It was reported that a patient (3 of 4) received a Fluzone SV vaccination on 11/28/2000. Reportedly the patient developed local redness within 1 hour of the injection. No specifics were provided. Further information is requested. From additional correspondence received 03/13/2001, it was reported that 48 hours post vaccine the patient experienced swelling and itching that progressed down her left arm past her elbow. Reportedly the patient recovered from this experience. Additional patient, vaccine, correct adverse event onset dates, vaccine administrator and responsible physician information were also provided. Y 11/28/2000 11/30/2000 2 PVT PVT NONE UNK U200100186 1
0177504 11/09/2001 FL 51.0 51 F 03/15/2001 It was reported that a patient (4 of 4) received a Fluzone SV vaccination on 12/01/2000. Reportedly the patient developed local redness within 1 hour of the injection. No specifics were provided. Further information is requested. From additional correspondence received 03/13/2001, it was reported that the patient awoke from sleep 12/01/2000 with pain, hardness and a 3cm burgundy colored area at the injection site. The patient was treated with Tylenol and Benadryl. The symptoms were resolved within 24 hours. Additional patient, vaccine, vaccine administrator and responsible physician information were also provided. Y 12/01/2000 12/01/2000 0 PVT PVT Premarin NONE Allergic to morphine sulfate. U200100187 1
0177505 11/09/2001 MA 45.0 F 01/22/2001 It was reported that a 45 year old female patient received a Fluzone SV vaccination on 11/29/2000. Approximately one hour after vaccination the patient became wheezy, developed a fever of 102F, muscle aches and chills. Further information is requested. U 11/29/2000 11/29/2000 0 UNK UNK U200100188 1
0177506 11/09/2001 IL F 03/12/2001 It was reported that a female patient received a Fluzone SV on 11/29/2000. Reportedly on 12/01/2000, the patient complained of redness and pain at the injection site. The vaccination was received in the flu clinic at Walgreens. From additional correspondence received on 03/06/2001, the vaccine administrator and the address of the responsible facility were provided. U 11/29/2000 12/01/2000 2 UNK UNK U200100200 1
0177508 11/09/2001 LA 54.0 54 F 02/28/2001 It was reported that a female pt received a Fluzone SV '00-'01 vaccination on 1/21/01. Reportedly, on 1/25/01, the pt was admitted to the hospital with flu-like symptoms. The physician does not yet know if it is a side effect of the vaccine or the actual flu. Further information requested. From additional correspondence received on 2/20/01, the responsible physician and vaccine administrator information was provided. Y U 01/21/2001 01/25/2001 4 PVT OTH U2001002340 1
0177509 11/09/2001 CA 1 .1 M 11/06/2001 The pt developed signs and symptoms of increased bruising over 2-3 days. On 8/9/00, PE showed (+) subconjunctival hemorrhage and ecchymosis over trunk, buttocks, arms and legs. Recovery to normal on 8/25/01. No RX given at clinic visit. Y Y 07/10/2000 08/09/2000 30 CBC persistently showed low platelets; initial platelets-14,000 and dropped to 8,000 PVT OTH NONE URI symptoms, no fever NONE 1
0177510 11/09/2001 FL 3.0 3 M 10/25/2001 Twenty four hours after the shot was administered pt experienced severe swelling at the neck especially his left lymph node. He was hospitalized for strep-pneumonia in July of 2000 and wondered if there was a connection. I wanted to communicate this info so it could be tracked and help other children and physicians. Noticed when he woke up from his nap. I was told he had a bacteria. Y Y 09/17/2001 09/18/2001 1 PVT PVT Pneumonia in 7/00 1
0177511 11/09/2001 NY 20.0 20 F 11/08/2001 Injection site soreness immediately which migrated to full arm then right torso and upper right thigh PM of 11/01/2001. Became dizzy, very hot (104)and numb on awakening and fell Tingling from neck down right side. Y Y 11/01/2001 11/02/2001 1 Blood work was normal PUB PUB NONE NONE Seasonal Allergies 1
0177512 11/09/2001 NY 70.0 M 11/08/2001 Bells Palsy (left sided facial weakness) Y U 11/06/2001 11/07/2001 1 Checking Lyme titer PVT UNK NONE NONE 1
0177514 11/09/2001 NY 50.0 47 F Aches, flu like symptoms, joints sore. U 01/10/1999 01/11/1999 1 PVT PVT NONE NONE 1
0177516 11/09/2001 NJ 46.0 46 F 03/08/2001 It was reported that a 46 year old female patient received a Fluzone SV vaccination on 11/29/2000. Reportedly sometime after the vaccination the patient developed pain, redness and ecchymosis at the injection site. From additional correspondence received on 02/21/2001, it was reported that the patient recovered from this experience. Additional patient, vaccine administrator name and address were also provided. Y 11/29/2000 OTH PVT U200100201 1
0177517 11/09/2001 FL 35.0 35 F 03/08/2001 It was reported that a 35 year old female patient received a Fluzone SV vaccination on 11/30/2000 at 10:15 am in the left forearm. Reportedly one hour later the patient complained of itching all over her body. Medication was given approximately one hour later. The patient also complained of dizziness and throat closing and still itching. From additional correspondence received 02/21/2001, it was reported, "reviewed, no additional information at this time" - CD 02/14/2001. This case is closed. N 11/30/2000 11/30/2000 0 UNK UNK U200100202 1
0177518 11/09/2001 FL 37.0 37 F 03/08/2001 It was reported that a 47 year old female patient received a Fluzone vaccination on 11/28/2000 at 8:00 am. Reportedly on 11-29-2000 at 10:00, the patient developed a localized area of cellulitis 6cm. Reportedly the patient recovered from this experience. From additional correspondence received on 02/21/2001, it was reported, "reviewed, no additional information at this time - CD 02/14/2001". This case is closed. Y 11/28/2000 11/29/2000 1 MIL UNK NONE NONE U200100203 1
0177519 11/09/2001 FL 44.0 F 03/08/2001 It was reported that a 44 year old female patient received a Fluzone SV vaccination. Reportedly sometime after receiving the vaccination the patient developed 3cm of cellulitis, urticaria and a sore throat. Further information is requested. From additional correspondence received on 02/21/2001, it was reported, "reviewed, no additional information at this time - CD 02/14/2001". This case is closed. N UNK UNK UNK U200100204 1
0177520 11/09/2001 FL F 03/08/2001 It was reported that a female patient received a Fluzone SV vaccination on 11/28/2000. Reportedly that same day the patient developed swelling and redness surrounding the injection site, itching and pain from the shoulder to the forearm. From additional correspondence received on 02/21/2001, it was reported, "reviewed, no additional information at this time - CD 02/14/2001". This case is closed. U 11/28/2000 11/28/2000 0 PVT UNK NONE NONE U200100205 1
0177522 11/09/2001 CA 29.0 29 M 01/23/2001 It was reported that a male patient received a Fluzone vaccination during Oct 1999. Approximately one month later the patient developed "flu-like" symptoms, feeling in his head like a head cold persisted. The patient has been seen by an Allergist and also has had an MRI. The MRI results were not provided. U 10/01/1999 11/01/1999 31 MRI - results not provided. UNK UNK 0200100207 1
0177523 11/09/2001 TX 54.0 54 F 03/20/2001 It was reported that a patient (1 of 2) received a Fluzone vaccination. Sometime after the vaccination the patient developed leg cramps. No specifics were provided. Further information is requested. From additional information received on 12/7/2000, it was reported that the patient received the Fluzone SV vaccination on 11/30/2000 at 10:00 am. Reportedly at 12:01 pm that same day the patient developed pain and cramping of the right calf. The patient was seen in the ER. The patient's recovery status is unknown. Additional patient, vaccine, vaccine administrator and responsible physician information was also provided. From additional correspondence received on 03/20/2001 it was reported that the patient recovered from this experience. Y Y 11/30/2000 11/30/2000 0 OTH PVT U200100211 1
0177524 11/09/2001 TX U 01/25/2001 It was reported that a patient (2 of 2) received a Fluzone vaccination. Sometime after the vaccination the patient developed leg cramps. No specifics were provided. Further information is requested. U UNK UNK U200100212 1
0177525 11/09/2001 IN 46.0 46 M 02/28/2001 It was reported that a 46 year old male patient received a Fluzone SV vaccination on 12/01/2000. Reportedly on 12/05/2000, the patient developed achy, stiff joints and some abdominal discomfort. These symptoms started on 12/05/2000 and are still continuing but the patient refused to be seen by the physician. From additional correspondence received on 02/20/2001, it was reported that the symptoms only lasted one day. Per physician, 02/13/2001, reviewed, no additional information at this time. This case is closed. Y 12/01/2000 12/05/2000 4 UNK UNK U200100213 1
0177526 11/09/2001 SC 38.0 F 03/14/2001 It was reported that a female patient (1 of 3) received a Fluzone SV vaccination. Reportedly the patient developed reaction of warmth, erythematous area around the injection site for 24+ hours, measuring more than 5cm and up to 10cm. Further information is requested. From additional correspondence received 03/06/2001, it was reported that the patient recovered from this experience. Additional patient, vaccine, vaccine administrator and responsible physician information were provided. Y PVT PVT Septra and Cortisporin otic allergies. U200100214 1
0177527 11/09/2001 SC 41.0 F 03/12/2001 It was reported that a female patient (2 of 3) received a Fluzone SV vaccination. Reportedly the patient developed a reaction of warmth, erythematous area around the injection site for 24 + hours, measuring greater than 5cm and up to 10cm. Further information is required. From additional correspondence received on 03/06/2001, it was reported that the patient recovered from this experience. Additional vaccine, patient, vaccine administrator and responsible physician information were provided. Y UNK UNK B/P medication NONE NONE U200100216 1
0177528 11/09/2001 SC 30.0 F 03/14/2001 It was reported that a female patient (3 of 3) received a Fluzone SV vaccination. Reportedly the patient developed reaction of warmth, erythematous area around the injection site for 24+ hours after the injection, measuring > 5cm and up to 10cm. Further information is requested. From additional correspondence received on 03/06/2001, it was reported that the patient recovered from this experience. Additional patient, vaccine administrator and the responsible physician information were also provided. Y NONE PVT UNK NONE Pregnant - second trimester. U200100217 1
0177529 11/09/2001 TN 45.0 45 F 03/08/2001 It was reported that a 45 year old female patient received a Fluzone SV vaccination on 10/16/2000 at 8:30 am. During the evening of 10/16/2000 the patient developed a large red circle on her left arm, that was raised and hot to the touch. In the morning of 10/17 the patient developed itching all over and her knees became red. Developed redness up to mid-chest. Also developed sores from the waist down. On 10/19 physician saw the patient. The patient's recovery status is unknown. From additional correspondence received on 02/21/2001, it was reported that the patient is still in treatment. The correct vaccination time was also provided. Y U 10/16/2000 10/16/2000 0 Vasculitis 11/30/2000 from biopsy. PVT UNK NONE NONE U200100218 1
0177530 11/09/2001 MO 51.0 51 F 03/08/2001 It was reported that a 51 year old female patient received a Fluzone SV vaccination on 11/29/2000. Reportedly on 12/05/2000, the patient developed systemic rash all over her body. The patient was given Xanax, Prednisone and Atarax. The rash was still persisting on 12/07/2000. The patient was diagnosed with fibromyalgia and migraine headaches and mixed tissues symptoms. The nurse stated that she is on lots of pharmaceuticals. From additional information received on 12/08/2000, it was reported the patient developed a rash approximately 48 hours after receiving the flu vaccine, not on 12/05/2000 as previously reported. Rash is pruritic and covers the majority of her body with the exception of her face, hands and feet. The patient is still complaining of symptoms on 12/07/2000. From additional correspondence received on 02/21/2001, it was reported, the patient has been previously diagnosed with fibromyalgia and migraine headaches and mixed tissue symptoms, was not diagnosed as previously reported. Y N 11/29/2000 12/01/2000 2 PVT PVT Zaroxolyn, Prednisone, Darvocet N 100, Diazepam, Zovirax, Celexa, Elavil, Combi Patch, Allegra and Plaquenil. NONE Fibromyalgia, hiatal hernia, seasonal allerigies, hypercholesterolemia, connective tissue disorders, fever blisters, and MVP. U200100219 1
0177531 11/09/2001 RI 77.0 77 F 01/25/2001 It was reportedd that a 77 year old female patient received a Fluzone SV vaccination on 11/29/2000. Within 30 minutes after the injection the patient developed tingling in and around her mouth, no respiratory distress and increased anxiety. The patient was transferred by rescue squad to the ER, treated and released to the family physician. Y U 11/29/2000 11/29/2000 0 UNK UNK U200100220 1
0177533 11/09/2001 FL 50.0 50 F 03/08/2001 It was reported that a 50 year old female patient received a Fluzone SV vaccination on 12/01/2000 in the PM. Reportedly the day after the vaccine was administered, the patient developed a 5" area of hardness, heat, redness and pain. The patient had no fever. The symptoms lasted for 3 days. the hard know remained through 12/05/2000. Reportedly the patient recovered from this experience. From additional correspondence received on 02/21/2001, it was reported, "reviewed, no additional information at this time. This case is closed. Y 12/01/2000 12/02/2000 1 PVT PVT NONE Allergic to penicillin. U200100222 1
0177535 11/09/2001 PA 48.0 M 01/25/2001 It was reported that a 48 year old male patient received a Fluzone SV vaccination on 12/05/2000. Reportedly sometime after the vaccination the patient developed a local reaction of redness, hardness and pain at the injection site. U 12/05/2000 UNK UNK U200100224 1
0177536 11/09/2001 WA 39.0 39 F 01/25/2001 It was reported that a 39 year old female patient received a Fluzone SV vaccination on 12/04/2000. Sometime after the vaccination the patient developed a local reaction, 4cm red, swollen tender area at the injection site which lasted for 3 days. U 12/04/2000 UNK UNK U200100225 1
0177538 11/09/2001 CA 61.0 61 F 01/25/2001 It was reported that a 61 year old female patient received a Fluzone SV and a Pneumovax vaccination on 12/05/2000. Approximately 5 hours after vaccination, the patient developed general malaise, difficulty on expiration and stomach pain, which lasted approximately 40 hours and completely subsided. Y 12/05/2000 12/05/2000 0 UNK UNK 0200100227 1
0177541 11/09/2001 IN 44.0 44 F 03/10/2001 It was reported on 12/12/2000, the patient developed a fever of 101F, severe body aches and malaise for approximately 5 hours. Also developed redness and swelling at the site. The patient's muscles ached for about 12 hours. The patient was treated with Tylenol. U 12/11/2000 12/12/2000 1 OTH UNK NONE NONE U200100230 1
0177542 11/09/2001 IA 45.0 45 F 03/27/2001 Reportedly about 45 minutes after vaccination, the patient complained of severe pain in the left deltoid radiating to the hand and clavicle. The patient still experiences sporadic pain, especially at night when trying to sleep. The patient was seen in the ER on 10/18, treated and released. On 11/01/2001 seen by family physician who ordered physical therapy for 1 week - no relief. On 11/14/2001 the patient was referred to an orthopedic surgeon. The patient now an appt with a neurologist next week. From additional correspondence received on 02/22/2001, it was reported "neurologist appt cancelled initially due to decreased pain in arm. Approximately the second week of January 2001, numbness and tingling started from the shoulder to the fingertips with occasional pain. Rescheduled appts 02/28/2001. On 03/14/2001 the patient had her appt with the neurologist. The physician also states there is probably muscle reaction to the vaccine itself. The patient continues to have numbness and tingling in the left arm and hand occasionally with occasional pain in the deltoid, as of 03/21/2001. Y N 10/18/2000 10/18/2000 0 Nerve conduction study = wnl PUB UNK U200100231 1
0177544 11/09/2001 FL 7.0 7 M 03/14/2001 Reportedly, 15-20 minutes after the vaccination, the patient developed wheezing, itching all over and runny eyes. The patient was treated with Benadryl and Albuterol. The patient recovered from this experience. Y 12/14/2000 12/14/2000 0 PVT UNK Kabuki syndrome, asthma and development delay. U200100236 1
0177545 11/09/2001 NY F 01/26/2001 Post vax, the patient reportedly developed Bells Palsy with left facial nerve paralysis. The patient was evaluated by a physician, underwent an MRI and a lumbar puncture. Steroid therapy was prescribed. The resolution is unknown. Y U 11/15/2000 11/16/2000 1 MRI and Lumbar puncture - results not provided. UNK UNK U200100239 1
0177546 11/09/2001 CO 66.0 66 F 05/04/2001 The patient reportedly developed heartburn immediately after the vaccination. The patient took Alka-Seltzer and the heartburn was resolved. From additional correspondence received 05/01/2001, it was reported there is no additional information available at this time. This case is closed. Y 01/05/2001 01/05/2001 0 PVT PVT NONE Allergic to Epinephrine, Tylenol and Cortisone. U200100282 1
0177547 11/09/2001 PA 20.0 20 F 01/28/2001 Reportedly at 6:20pm the patient complained of feeling of fullness in her chest. There was no wheezing. The patient was treated with Benadryl and given instructions to follow-up. There was no induration at the injection site. Reportedly the patient recovered from this experience. Y 10/26/2000 10/26/2000 0 UNK OTH PVT NONE NONE U200100284 1
0177548 11/09/2001 PA 14.0 14 F 03/14/2001 The evening of the injection, the injection area on the left upper arm was red, slightly raised and very sore. The erythema was approximately 3" long and 3/4" wide and felt hot to the touch. Stayed like this for 5 days. As of 01/09/2001, the area is no longer sore and the red strip is very slight but still visible on her arm. Additional correspondence received on 02/15/2001 reported that the patient recovered from this experience. It was requested on 02/12/2001 to send a copy of this report to MD. No further information was provided from correspondence returned on 03/08/2001. Y 12/28/2000 12/28/2000 0 OTH UNK NONE U200100287 1
0177549 11/09/2001 PA 47.0 47 F 05/03/2001 It was reported that the patient experienced a local reaction the next day after the vaccination with a slightly raised, red rash the size of your hand. It was painful, itchy and she had some neuritis and numbness the length of her arm, radiating from the vaccination site. The patient also had muscle soreness. The patient was treated with Benadryl and Excedrin, which alleviated her symptoms. From additional correspondence received on 04/20/2001, it was reported that the patient recovered from this experience. This case is closed. Y 01/04/2001 01/05/2001 1 OTH PUB NONE Allergic to penicillin, sulfa, stinging insects, and all diagnostic contrast dyes. U200100288 1
0177550 11/09/2001 TX 42.0 42 M 01/28/2001 It was reported that a 42 year old male received Fluzone SV '00-'01 USP from his Employee Health on 12/7/00. Within several days, he had arthritic-like pain in his shoulder and joint where vaccine was given. The was also a round, raised rash. The doctor put him on Prednisone 6 day pack. Now, 1 month later, there is a scaly, psoriasis-looking rash that is bumpy and scabbed over and 1/2" in diameter. Y N 12/07/2000 12/09/2000 2 OTH OTH U2001002940 1
0177551 11/09/2001 MI 41.0 41 F 03/10/2001 A few days after the vaccination, the patient reportedly developed a local reaction at the injection site and then developed Pityriais-Rosea. No further information is anticipated. This case is closed. U 12/16/2000 PVT PVT NONE NONE U200100295 1
0177552 11/09/2001 PA 41.0 41 F 05/03/2002 From an initial report received on 01/12/01, it was reported that a 41 year old female was given Fluzone SV '00 -'01 vaccine on 01/09/01. patient reportedly "developed edema and joint pain- elbow, wrists and ankles and fingers, also neck pain the evening after vaccination still persist". From additional correspondence received on 02/16/01, additional patient, vaccine, responsible physician and vaccine administrator information was provided. N 01/09/2001 01/10/2001 1 NONE OTH PUB NONE Unspecified drug allergies. U200100297 1
0177553 11/09/2001 MI 39.0 39 F 03/10/2001 The patient reportedly experienced left arm pain, a burning sensation and swelling on 01/11/2001 after being seen by a private physician. The patient was treated with ibuprofen. From additional correspondence received on 02/27/2001, it was reported the patient is currently being treated for bursitis. The Dr advised these symptoms were not caused by the flu vaccine. No further information is anticipated. This case is closed. Y U 12/28/2000 12/28/2000 0 OTH PVT NONE UNK U200100299 1
0177555 11/09/2001 MI 51.0 51 M 04/04/2001 Post vax, the patient reportedly experienced weakness in both feet and legs, uncoordinated, and swelling of both hands. The patient was evaluated by a neurologist. There was no confirmed diagnosis. The symptoms lasted 2 weeks and have resolved. Y Y 11/19/2000 11/26/2000 7 EMCT done, ANA/SED rate elevated OTH OTH NONE U200100302 1
0177556 11/09/2001 NY 20.0 20 F 01/29/2001 From a report received on 01/04/01, it was reported that 10 minutes after pt received her vaccine, her entire arm became itchy with redness from itching at hand between thumb and forefinger. Treatment of Benadryl given with relief after 10-20 minutes. Y 11/15/2000 11/15/2000 0 OTH UNK Prevacid NONE Allergic to beans and peas u200100303 1
0177557 11/09/2001 CO 64.0 64 F 03/10/2001 About 6 hours after pt received vaccine she developed tachycardia-120 bpm. The pt was seen in ER. Pt was back to normal in 2 or 3 days. From additional correspondence received on 02/27/01, additional pt, responsible Dr, vaccine administrator and laboratory data were provided. No further information is anticipated. This case is closed. Y Y 11/21/2000 11/21/2000 0 In ER EJG -sinus tachycardia was negative, 115 BPM-89 on EKG, VQ lung scan-negative and chest x-ray negative. PVT OTH Prempro NONE Benign positional vertigo, HTN, Palpitations & possible undocumented paroxysmal SVT U200100320 1
0177558 11/09/2001 NJ 33.0 33 F 02/12/2001 It was reported that immediately after vaccination the pt could taste the vaccine, had esophageal spasms and a burning and nasal sensation, no respiratory distress or anaphylaxis. These symptoms lasted about 1/2 hour. Pt took Benadryl and was also seen in the emergency room. Further information is requested. Y U 01/10/2001 01/10/2001 0 OTH OTH U200100397 1
0177559 11/09/2001 PA 61.0 61 F 02/15/2001 It was reported that 3- 4 days after receiving vaccine the pt's hair fell out. Pt had same experience with Hepatitis A & B vaccines, she lost 3/4 of her hair volume in 1998. Further information is requested. U 11/01/2000 11/04/2000 3 OTH OTH U200100417 1
0177560 11/09/2001 NY 42.0 42 F 03/02/2001 Right after vaccinations the pt complained of feeling hot, clammy, and woozy and a light headache, skin color flushed. Pt was sidephhoretic. Pt had blood pressure taken several times until was normal. Pt stated that she felt hot and complained of tingling in both feet. Stated throat felt slightly tight when swallowing. No erythema on right or left arm. Pt stated she felt lightheaded. Pt given Epinephrine and Claritin with samples of Claritin to take home. At 1:25 pt still complained of tingling left arm and left leg but no signs or symptoms of distress. Was discharged per Dr. Y Y 01/29/2001 01/29/2001 0 OTH OTH Naproxen NONE NONE 02001004430 1
0177562 11/09/2001 OH F 04/09/2001 Two days after vaccination pt presented with redness, swelling, warmth, and inflamed area. Seen by physician and diagnosed with cellulitis. Antibiotics were prescribed and pt is responding to treatment. Additional correspondence received on 04/06/2001, it was reported that the pt recovered from this experience. Y Y 03/13/2001 03/15/2001 2 NONE OTH PVT NONE NONE U200100517 1
0177565 11/09/2001 PA 46.0 46 F 05/03/2001 From an initial report dated 04/20/01, it was reported a pt vaccinated on 01/04/2001 pt had a local reaction the next day. the pt developed a slightly raised, red, rash, the size of your hand. It was painful, itchy and she had some neuritis and numbness the length of her arm radiating from vaccination site. She also had muscle soreness. Spoke with her and she had just taken Benadryl and Excedrin on day 3. That did alleviate her symptoms. She is going to try to get the lot number from her vaccine. Pt called in 01/10/2001 with lot number. Y 01/04/2001 01/05/2001 1 UNK UNK U200100678 1
0177566 11/09/2001 PA 62.0 62 F 05/14/2001 It was reported that a 62 year old female pt received a Fluzone SV 00-01 vaccination in 11/00. Reported ten days after vaccination the pt developed painful spot on index toe on foot. After the first of the year (Jan 2001) the pt developed painful spots on right side of back-possible atypical shingles U 11/01/2000 11/10/2000 9 OTH OTH NONE NONE 02001007100 1
0177567 11/09/2001 CT 62 F 07/13/2001 After receiving vaccines, the pt developed numbness of the right deltoid, onset date not specified, which had progressively improved. From correspondence received on 06/29/01 it was stated shortly after vaccination pt's arm was like it was dead. To hold a cup of tea left hand had to pick right hand up-weak. Gradually gone, reported 100% return to normal on 06/12/01. Y 01/03/2001 PVT PVT Accupril, HCTZ, Premarin, Fosmax, Ambien, Aspirin NONE Decreasing hearing-left, 5 unsuccessful pregnancies, TAHBS, seasonal allergies, HTN, GERD, LS Disc herniation, Osteoporosis, High cholesterol, Eczema 02001007340 1
0177568 11/09/2001 FL 76.0 76 M 07/13/2001 It was reported that an 76 year old male pt received a Fluzone SV 00-01 vaccination in 11/2000. Reportly sometime after the vaccination (date not specified) the pt developed headaches, diaphoresis, abdominal pain, myalgia, and mouth. No further information was provided from mailed correspondence returned on 06/29/2001. N 11/01/2000 Negative laboratory studies PVT OTH Prostate cancer, Arthritis U200100739 1
0177569 11/09/2001 NY 4.0 4 M 11/08/2001 Varicella zoster, developed approximately 11/01/2001 09/07/2001 11/01/2001 55 PVT PVT NONE NONE NONE 1
0177573 11/12/2001 0.25 F 11/07/2001 Choking spell (choking), aspiration spell (aspiration), not breathing well (dyspnoea, NOS), pale (pallor), perioral cyanosis (cyanosis NOS). F/U states: Country of origin; United States. A 3 month old female received her 2nd doses of Prevnar, Menomune, Havrix and Rabies vaccine (the given batch no. UA598AB is unknown for RabAvert) on 8/23/01. Approx. 5-6 hours, post vax, the infant experienced a "choking/aspiration spell". She also was "not breathing well" and turned pale with perioral cyanosis. EMS were called and the child was seen in an ER. The reporter noted that the infant recovered before reaching the ER. She was hospitalized where a result of a CBC, UA and "basic metabolic panel" were normal. Seriousness criteria: hospitalization, life-threatening. Causality: possible (for possible allergic reaction). No change is risk-benefit-ratio. No measures necessary. Addendum 11/15/01: According to information received, no rabies vaccine was administered to the child. The vaccines administered on 8/23/01 were Infanrix, Prevnar, Act-Hib and IPOL, rather than Havrix, Prevnar, Menomune and Rabies vaccine, as originally reported. Consequently, for RabAvert, this case is reclassified as non-company-drug. Causality unrelated (rabies was not administered. Y Y Y Y 08/23/2001 08/23/2001 0 CBC, UA and "basic metabolic panel" were normal. OTH OTH NONE UNK CMA20010680 1
0177575 11/12/2001 SC 0.5 0 .5 F 11/07/2001 A 6 month old white female with atopic dermatitis and no known illness at the time of vaccination, was vaccinated with a second dose of hep B vaccine recombinant (yeast), IM in the right thigh, on 12-MAR-2001. Concomitant therapy, that day, included the third doses of ACT-HIB, Prevnar and Tripedia. There were no additional concomitant medications reported. The pt presented to the physicians office with a "few fine, minimally raised red patches 1-3mm in diameter" on her face and trunk. On 12-MAR-2001 the pt developed urticaria within 15 minutes of the immunization and was treated with Benadryl. The pt was sent to an allergy specialist for skin testing. The pt had tested positive for thimerosal allergy. Subsequent follow up indicated that the kin testing revealed an allergy to hep B vaccine recombinant (yeast) and Tripedia, but results were negative for allergy to Prevnar and ACT-HIB. On 12-MAR-2001, the pt recovered from her experience. Urticaria, testing positive for thimerosal and "allergy to DTaP and HBV" were determined to be other important medical events. No further information is available. Y Y 03/12/2001 03/12/2001 0 PVT PUB eczema WAES01062501 1
0177577 11/12/2001 TX 65.0 65 F 11/07/2001 Information has been received from an RN concerning a 65 year old female who was vaccinated at another physicians practice with the 1st dose of pneumococcal vaccine 23 polyvalent at the age of 52 and her 2nd dose at the age of 60. On 10/29/01, she was vaccinated with a 3rd dose of pneumococcal vaccine 23 polyvalent (lot 640744/0994L). On 10/29/01, about 4 hours, post vax, the pt came back to the office with pain in her arm, neck, back and under her breast. She had chills but no fever. She was also vomiting. The injection site was tender to touch. Subsequently, the pt was hospitalized. IV fluids and diphenhydramine hydrochloride (Benadryl) were started. She was also started on therapy with promethazine hydrochloride (Phenergan) for the vomiting. Additional information has been requested. F/U states: The pt was treated with Benadryl, IM, in the physician's office and was kept in the office for observation. The pt still complained of pain so she went to the hospital and was admitted to the telemetry unit where she was treated with IV fluids, diphenhydramine HCI q6 hours and meperidine hydrochloride (Demerol) for pain. She was also started on therapy with Phenergan for the vomiting. The pt was discharged from the hospital on 10/30/01. The discharge dx was intractable pain. The pt was seen in the physician's office on 11/12/01 and was currently receiving physical therapy for her pain. No further information is expected. The pt had no adverse reaction after receiving the 1st and 2nd doses. Y Y U 10/29/2001 10/29/2001 0 OTH OTH Darvocet-N; Buspar; Nexium; Pravachol Colonic polyp; doxycycline allergy/drug allergy; gastritis; hyperlipidemia; iodine allergy; pain; penicillin allergy; F/U states: fibromyalgia; chronic pain syndrome; Cipro allergy WAES01106325 1
0177581 11/12/2001 WI 32.0 31 F 11/06/2001 Information hasbeen received from a reistered nurse concerning a 32 yearold female with codeine allergy who on 10/18/2000 was vaccinated with a dose of the measles virus vaccine live (627545/0624K). On 1/5/01, pt was vaccinated with the measles virus vax. On 1/5/01, the pt stated she might be 6 weeks pregnant. Unspecified medical attention was sought. In follow-up, nurse reported that the pt's last menstrual period was 11/5/00. The pt's pregnancy was confirmed by US. The pt had two previous pregnancies and two previous live births without any birth defects. The pt did not have a history of miscarriage or stillbirth the patient was on vitamins (unspecified) during her pregnancy. On 2/15/01, pt had sinusitis and was placed on therapy with amoxicillin until 2/25/01. On 3/7/01, pt developed respiratory infection and was treated with azithromycin IV and Phenergan. On 7/8/01, pt went into preterm labor (37 week gestation). Pt was given terbutaline and nifedipine. On 8/15/01, pt delivered a normal 9 lb 5 oz male. The baby did not have any congenital anomalies. The infant did have reflux. Upon internal review, preterm labor was determined to be an other important medical event. No further info is available. Y 01/05/2001 02/15/2001 41 OTH OTH Vitamins (unspecified) Pregnancy, codeine allergy WAES01010461 1
0177582 11/12/2001 TX 11.0 11 M 02/08/2002 Pt was referred from an allergy specialist for vax. Approximately 48 hours post vax, pt developed a severe injection site reaction. The area of induration was 10-15 cm in diameter. It was reported that an empiric anti-staph antibiotic was started with no improvement. He then started outpt therapy with Ancef. The area was reported to exhibit thickening and erythema. At the time of this report, the area was still indurated and peeling. The pt sought medical attention and was hospitalized for treatment of these events on an unspecified date. Follow-up info recvd from an MD indicated that the child was hospitalized for what "looked like a cellulitis." The child had been receiving IV antibiotics for 2 weeks at his home. The MD noted that because he was not the one who administered the vax, he was not sure if the vial was a multi-dose vial or not. Follow-up info recvd from MD indicated that the pt was seen in office on 10/30/01, 3 weeks since the vax and the onset of the cellulitis and fascitis syndrome. The pt had an 8 cm area of induration at the wides diameter of his arm. The MD was going to have the pt continue on the IV antibiotics at home and have another MRI done. Addtl info has been requested. Initial and follow up info has been recieved from a physician concerning an 11 year old male student with a history of periodic fevers who on 10/4/01 was vaccinated in the left upper arm with the first dose (635893/1197K) of pneumococcal vaccine 23 polyvalent upon referral from an allergy specialist for an immunology work-up. Concomitant therapy on 10/4/01 included a dose in the left thigh of diphtheria toxoid/tetanus toxoid. The child's skin eventually desquamated. The physician reported that the IV antibiotics were discontinued on 11/6/01 and that the pt recovered the same day. No further info is available. Y Y 7 Y 10/04/2001 10/07/2001 3 10/11/01 Biopsy-nothing on culture; MRI-involvement of fascia; Erythrocyte-elevated PVT OTH UNK Fever WAES01103373 1
0177583 11/12/2001 LA F 11/06/2001 Information has been received from a pharmacy sales representative concerning a female who on approx. 10/22/01 was vaccinated with pneumococcal vaccine 23 polyvalent. A few days later, in 10/01, the pt was hospitalized for a "infection". The same source also provided information regarding other persons' experiences with pneumococcal vaccine 23 polyvalent (WAES 01110031). Additional information has been requested. Y Y U 10/22/2001 10/25/2001 3 OTH OTH UNK UNK WAES01106155 1
0177584 11/12/2001 NY 58.0 58 M 11/06/2001 Information has been received from a woman in a physician's office concerning a 58 year old Caicasian male pt with hyperlipidemia and coronary artery disease and no known allergies and a history of asbestos exposure who on 10/18/2001 was vaccinated in the right arm with a second dose of pneumococcal vaccine 23 polyvalent. Concomitant vaccinations on 10/18/01 included a second dose in the right arm of Fluvirin. Other concomitant therapy included atenol, lisinopril, aspirin and hydrochlorothiazide. Subsequently, the patient developed erythema with 3+ edema. The affected area was from the injection site(deltoid)to his wrist, affecting his upper arm and forearm. It was reported that his arm was so bad that he couldn't touch his head. He was started on prednisone over the weekend (on approximately 10/20/20010. The condition was reported to not be resolving so that patient was started on amoxicillian trihydrate (+)Clavulanate potassium 875 mg twice daily for cellulitis. The reporter indicated that she thought the patient was improving because their office had not heard anything further from him. The reporter expressed a concern with the lot since 3 patients received the vaccine and "have had reaction". FOLLOW-UP information from a physician indicated that the patient developed swelling, erythema, pain of right arm from injection site to wrist, with a fever of 101. The patient was treated with antibiotics with resolutiuon of symptoms over approximately 10 days. No further information is availble. Y Y 10/18/2001 10/19/2001 1 PVT OTH aspirin; Tenormin; hydrochlorothiazide; Zestril Asbestos exposure; Coronary artery disease; hyperlipidemia WAES01104569 1
0177591 11/12/2001 MA 5.0 5 F 10/30/2001 Approximately 10 min post vax, pt developed cough, gagging sensation, funny feeling in mouth, perioral swelling. Pt was given epi 1:1000 0.2ml SQ and diphenhydramine 12.5mg po. Symptoms improved, but then pt developed urticaria 50 min later. She recvd 2nd epi 0.2ml SQ and was transported to the hospital. Y Y Y Y 10/30/2001 10/30/2001 0 PVT PUB Milk of magnesia NONE Congenital hypothyroidism; anal achalasia; EMLA burning 1
0177592 11/12/2001 38.0 38 F 10/29/2001 Pt experienced an anaphylactic reaction within 15 minutes of receiving vax. Pt required medical intervention, intubation and hospitalization in ICU. Y Y U 10/29/2001 10/29/2001 0 OTH OTH Allergy to cats, penicillin, cigarette smoke; possibly slightly allergic to eggs; asthma 1
0177593 11/12/2001 CA 1.3 1 .3 M 10/26/2001 12/03/1997 fever 3 days, eyes puffy, fussy, mild cough, runny nose, puss very early peril orb cellulitis, augment in. 12/10/1997 5 days diaper rash, red scrotum and pus, s dellitis lesions, candid diaper rash, nystatin cream. 12/12/1999, Hypotonia throughout extremities and trunk, 7/01/1999, Speech, hearing, intuening, poor eye contact concerns. 98/11/1999, Autism, significant delay in speech. Y N 11/17/1997 12/03/1997 16 Heavy metal lab test; IgG, etc. PVT OTH Hydrocortisone 1% for eczema as needed. In-toeing, muscular skeletal, mild metatarsus adduction, mild URI, slight eczema In-toeing/bow leg (lower legs) 1
0177594 11/12/2001 CA 1.0 1 .0 M 10/26/2001 8/13/97, pt's legs and feet gave way. He was bow-legged in lower legs and his feet turned in. Pt noted to have poor eye contact at 18 mos of age at which time milk addiction also started. 02/12/1999 pt had hypotonia throughout extremities and trunk. 7/1/99 pt was intoeing and had poor eye contact. 8/11/99 pt diagnosed as having autism with significant delay in speech. Y N 07/23/1997 08/13/1997 21 Heavy metal lab test, etc. PVT OTH Hydrocortisone 1% for eczema as needed NONE Mild atopic dermatitis Rash all over body~Hep B (no brand name)~3~0.00~In Patient 1
0177595 11/12/2001 CA 0.75 0 .8 M 10/26/2001 4/29/97-Rash all over body, cranky, decreased appetite and 3 days of fever. 2/12/99-Hypotonia throughout extremities and trunk. 7/1/99-Speech, hearing, in-toeing and poor eye contact concerns. 8/11/99-Autism and significant delay in speech. Pt had yellow eye discharge at 6 months of age with his 3rd polio (+) DTP (+) Hib. Y N 04/21/1997 04/29/1997 8 Heavy metal lab test, etc. PVT OTH Dry skin; atopic dermatitis 11/18/96-mild atopic dermatitis 1
0177596 11/12/2001 CA 0.5 0 .5 M 10/26/2001 2/14/97-Eye discharge (yellow), fever for 2 days and a cough. 2/12/99-Hypotonia throughout extremities and trunk. 7/1/99-Speech, hearing, in-toeing and poor eye contact concerns. 8/11/99-Autism and significant delay in speech. Y N 01/20/1997 02/14/1997 25 Heavy metal lab tests, etc. PVT OTH NONE 11/18/96-Mild atopic dermatitis; 12/20/96-Discoloration around eyes, bluish mark on bridge of nose 1
0177597 11/12/2001 CA 0.3 0 .4 M 10/26/2001 12/20/96-Discoloration around eyes and bluish mark on bridge of nose. 2/12/99-hypotonia throughout extremities and trunk. 7/1/99-Speech, hearing, in-toeing and poor eye contact concerns. 8/11/99-Autism and significant delay in speech. At 2 months of age, pt had right eye discharge, post vax of 1st , Polio (+) DTP (+) Hib. Y N 11/18/1996 12/20/1996 32 Heavy metal tests, etc. PVT OTH mild atopic dermatitis None 1
0177598 11/12/2001 CA 0.2 0 .2 M 9/28/96-Right eye discharge, possible LDS (mild) and URI. 11/18/96-Mild atopic dermatitis. 2/12/99-Hypotonia throughout extremities and trunk. 7/1/99-Speech, hearing, in-toeing and poor eye contact concerns. 8/1/99-Autism and significant delay in speech. Y N 09/16/1996 09/28/1996 12 Heavy metal lab tests, etc. PVT OTH NONE NONE 1
0177599 11/12/2001 CA 0 .0 M 10/26/2001 2/12/99-Hypotonia throughout extremities and trunk. 7/1/99-Speech, hearing, in-toeing and poor eye contact concerns. 8/11/99-Autism and significant delay in speech. Y N 07/24/1996 Heavy metal lab tests, etc. PVT OTH remove circumcision 7/17/96-Circumcision and slight jaundice; 7/18/96-Diarrhea-possible gastroenteritis, slight jaundice and yellow eyes 1
0177600 11/12/2001 ME 43.0 43 F 10/29/2001 Febrile illness with adrenal insufficiency in pt with Addison's disease. Y 2 Y 10/26/2001 10/27/2001 1 Labs-WNL PVT PVT Cortef; Florinef Addison's disease 1
0177601 11/12/2001 TN 67.0 67 F 10/15/2001 Pt noted some itching at site of injection about an hour after receiving vaccine. Itched until about 8:00 pm 10/03/2001. Pt called back to state (10/04/2001, 4:00 pm) that the arm was red, hard, swollen, tender, and warm. No elevation of temperature noted. Much improved by 3 days. Y 10/03/2001 10/03/2001 0 PUB PUB Thyroid medication NONE Thyroid condition TN01054 1
0177602 11/12/2001 FL 53.0 53 F 10/31/2001 The patient complained of flu like symptoms; body aches and chilly feeling. The patient developed redness at the injection site in an 3 cm area. The redness, swelling and pain increased on 10/30/2001 with swelling to the elbow. U 10/29/2001 10/29/2001 0 PUB PUB Nasocort, Serevent, Albuterol, Atrovent NONE Emphysema FL01014 1
0177603 11/12/2001 IN 40.0 40 F 11/05/2001 Post vax, the patient complained her index finger and thumb on her left hand went completely numb, preceded by tingling. Y 10/31/2001 10/31/2001 0 NONE PVT PVT Glucophage, cozaar, cholestin NONE DM Type II, GERD, Hypertension 1
0177604 11/12/2001 SC 69.0 69 F 10/31/2001 The patient complained of redness, swelling, itching and warmth to the injection site. Y 10/29/2001 10/29/2001 0 PUB PUB NONE SC0156 1
0177605 11/12/2001 SC 70.0 70 M 10/31/2001 The patient's spouse reports the patient had a local reaction to the left arm with redness and swelling at the injection site. Y 10/29/2001 10/29/2001 0 PUB PUB NONE NONE SC0155 1
0177606 11/12/2001 TN 73.0 73 F 11/05/2001 The patient complained of soreness and redness at the injection site the day after the vaccination. The area around the injection site was approximately 6" long and 4" wide and was raised and red. The patient was treated with Benadryl and Tylenol. Y 10/30/2001 10/31/2001 1 OTH PVT Pravachol, Verapamil NONE NONE 1
0177607 11/12/2001 MI 79.0 79 F 11/02/2001 Approximately seven hours post vaccine the patient had a sudden onset of vertigo, near syncope and several episodes of vomiting. 911 was called by the family. The patient's vital signs were checked, but the patient declined treatment or transport to the hospital. Y 10/29/2001 10/29/2001 0 NONE PVT UNK Lipitor, HCTZ, Toprol, Persantine, ASA, Celebrex, Xalatan, Occupres, Calcium and Vitamin D, Multivitamin, Glucosamine NONE Environmental allergies, HTN, TIA, ASHD, Arthritis, Glaucoma, Cataracts, Hyperlipidemia 1
0177608 11/12/2001 MI 56.0 56 F 11/05/2001 The patient developed hives over her entire body starting from her feet and spreading upwards around 5:30 pm, 11/03/2001. Y 11/03/2001 11/03/2001 0 NONE PUB PVT NONE NONE Scoliosis, polio-post polio syndrome 1
0177609 11/12/2001 TN 76.0 76 F 10/26/2001 The patient experienced soreness overnight and swelling to the elbow. The patient was seen in the office and her left arm was swollen the elbow and warm to the touch. U 10/24/2001 10/24/2001 0 OTH OTH Lipitor, Lanoxin, Nifedipine, Isosorbide, Celebrex, Premarin 1
0177610 11/12/2001 TN 40.0 40 F 10/26/2001 Within 10 minutes post vax, the patient experienced heart arrhythmia, her airway was tight, she was nauseous and sweating. Patient was treated with Epipen and taken to ER. Doctors determined her reaction was due to lactose intolerance. Y Y 10/26/2001 10/26/2001 0 OTH OTH 1
0177611 11/12/2001 MA 29.0 29 F 11/01/2001 Post vax the patient reported itching and redness of the left deltoid. U 11/01/2001 11/01/2001 0 Allergy tests PUB PVT Ibuprofen, Allegra, Albuterol inhaler NONE Allergies 1
0177612 11/12/2001 CA 57.0 57 F 11/05/2001 The patient reported redness and pain at the injection site in an area 4" in diameter. The patient complained of pain from the elbow to the shoulder. Symptoms subsided in 5 days. Y 11/01/2001 11/01/2001 0 NONE OTH OTH NONE NONE 1
0177613 11/12/2001 WI 59.0 59 M 10/31/2001 The patient developed cellulitis one day post vax. Y U 10/29/2001 10/30/2001 1 NONE PVT PVT Coumadin, Prevacid, Vitamin E Aortic Valve Replacement 1
0177614 11/12/2001 MI 82.0 82 F 10/25/2001 On 10/19/2001 the patient developed flu like symptoms which gradually worsened. The patient complained of chills, hot and cold, cough, red and sore upper palate and throat, sore tongue, sore joints and loss of appetite. The patient was treated with Xylocaine gel, Swish and Swallow, and Tylenol. Y Y 10/18/2001 10/19/2001 1 CXR, Labs PVT PVT NONE Allergies; sulfa, penicillin 1
0177615 11/12/2001 CA 76.0 76 F 11/10/2001 Post vax, the patient complained of a sick feeling, very tired, loss of appetite, leg cramps and facial flush. These symptoms lasted 7 days. Y 10/17/2001 10/18/2001 1 NONE PVT PVT Inderal, Pnemona, Provera, Plendil, ASA, Oscal, St John's Wort, Lithium, Ginko baloba NONE HTN, cataract, lumbar stenosis, asthma, anxiety, hyperlipidemia, peripheral neuropathy 1
0177616 11/12/2001 TX 52.0 52 F 11/04/2001 Post vax, the patient developed abdominal hives, palmar itching, swelling and angioedema of her lip. Y 11/03/2001 11/03/2001 0 NONE MIL MIL Estradiol, Actenol NONE Allergic rhinitis, perenial mild 1
0177617 11/12/2001 MI 58.0 58 M 10/04/2001 Ten minutes post vax the patient complained of feeling shakey and his throat feels tight. The patient was treated with Benadryl. Y Y 10/04/2001 10/04/2001 0 PUB PUB Lipitor, Lasix, Toprol, Celebrex, Imdur, Captopril, Neurontin, ASA CAD, Smoker, Hyperlipidemia, S/P Stent Placement MI2001084 1
0177618 11/12/2001 MI 23.0 23 F 10/19/2001 Post vax the patient developed a blister on her left arm and her left arm was swollen. There was no evidence of cellulitis. Y U 10/16/2001 10/18/2001 2 PUB UNK Prednisone, Synthroid, Procardia, Plaquenil, ASA, Calcium Headaches, Lupus Allergic to Penicillin MI2001086 1
0177619 11/12/2001 CA 61.0 61 F 11/02/2001 Post vax the patient developed swelling and reddening of the right deltoid. The patient was treated with cold compresses. U 11/01/2001 11/02/2001 1 OTH OTH Fosomax, Atrovent, Tylenol 3 Chronic bronchitis, osteoporosis, post menopausal dysuria. 1
0177620 11/12/2001 AL 36.0 37 F 10/31/2001 Post vax the patient complained of swelling arms, nausea, and headaches. U 10/29/2001 10/30/2001 1 PVT UNK NONE Pharyngitis AL0112 1
0177621 11/12/2001 VA 43.0 43 F 10/15/2001 Post vax the patient experienced vesicular eruptions, erythema, warmth and induration at the injection site, a mild headache, myalgia and a low grade fever. Y Y 09/28/2001 10/05/2001 7 NONE PVT PVT HCTZ, Serevent, Flovent, Singulair, Fiorinal, Atuss MS NONE Asthma, Migraines Fever & Chills~Pneumo (Prevnar)~~42.00~In Patient 1
0177622 11/12/2001 NY 78.0 78 F 10/26/2001 Post vax the patient developed a swollen arm, painful to touch. The patient was treated with Tylenol and recovered. Y 10/12/2001 10/12/2001 0 UNK UNK NONE 1
0177623 11/12/2001 MS 47.0 47 F 10/25/2001 Post vax the patient developed a very inflamed area 7-8 cm /809 cm in diameter, bruised in the middle. The right arm was very sore and could not be picked up without using the left arm. The patient was treated with Benadryl and ice packs. U 10/22/2001 10/23/2001 1 NONE PUB UNK NONE MS01055 1
0177624 11/12/2001 OR 65.0 65 F 10/18/2001 The patient felt sick for a few minutes post vax. The next day the patient had swelling that lasted a few days, the size of a baseball. The patient's arm is now bruised, but clearing. Y 10/11/2001 10/12/2001 1 NONE OTH UNK NONE OR200142 1
0177625 11/12/2001 MN 43.0 43 F The patient's arm was red, warm and ached after vaccination. Y 11/02/2001 11/03/2001 1 PVT PUB 1
0177626 11/12/2001 MN 5.0 5 M 11/01/2001 Redness, warmth and swelling developed 36 hours post vaccine with the left arm measuring 4 cm larger than the right. Probable cellulitis. Y U 10/30/2001 10/31/2001 1 NONE PVT PVT NONE History of viral induced bronchospasm 1
0177627 11/12/2001 TN 68.0 68 F 11/05/2001 The patient complained of soreness, redness, and warmth around the vaccination site the day after injection. The affected area was 2" wide x 4" long and was slightly raised. After 3 days the area was still slightly sore, but the redness was gone. Y 10/30/2001 10/31/2001 1 OTH PVT Evista, Spironolactone, Multivitamin, Echinacia NONE NONE 1
0177628 11/12/2001 NJ 44.0 44 F 11/05/2001 Post vax the injection site was red, hot and itchy. The patient had hives on her chest and abdomen. The patient was treated with Medrol Dispenspack and Zyrtec. Y 09/24/2001 09/27/2001 3 PVT PVT Lithium None Sulfa and acetameniphen 1
0177629 11/12/2001 TX 52.0 52 F 11/01/2001 The patient developed redness and itching at the injection site in an area 50mm long x 10mm wide. The patient was treated with cold packs and Claritin. U 10/31/2001 11/01/2001 1 NONE PVT PVT Zocor, Claritin, Premarin, Flonase High Cholesterol Heart Murmur, Hay fever, Arthritis, High Cholesterol, Allergic to Sulfa 1
0177630 11/12/2001 RI 7.0 7 M 11/05/2001 Approximately 4-5 diameter hot erythematous reaction on left deltoid-Benadryl 2 tsps every 4-6 hrs for reaction prescribed. Y Y 10/29/2001 10/30/2001 1 NONE PUB PUB Zyrtec and Flonase NONE NKDA, allergic rhinitis, and suspected ADD 1
0177631 11/12/2001 IN 1.0 1 .0 M 10/15/2001 Pt developed a large red, warm, area surrounding vaccine site w/advancing erythematous boarder. Y 10/01/2001 10/02/2001 1 NONE PVT PVT NONE NONE NONE 1
0177632 11/12/2001 PA 1.7 1 .7 F 09/10/2001 Mom reported that child developed enlarged lymph nodes in the right femoral area, a knot at the site of injection the size of a golf ball, and redness the size of a quarter after being immunized on 9/6/01. she stated the same reaction occurred after the first Prevnar on 7/5/01 Lymph nodes still enlarged off and on. U 09/06/2001 09/06/2001 0 PUB PUB NONE NONE NONE PA0160 1
0177633 11/12/2001 PA 0.25 0 .2 M 10/05/2001 8/2/01 leg sore, Tylenol given. Won't take bottle. Isn't drinking. Referred to Md. 8-3-01 child ok. Seen Md -ok. As of 10-05-01 child ok. Y Y 08/01/2001 08/01/2001 0 NONE PUB PUB NONE NONE NONE PA0159 1
0177634 11/12/2001 CA 0.3 0 .4 M 10/29/2001 Mom reported infant received Prevnar vaccine on 10/17/01. On 10/21/01 she noticed her infant had a mild case of hives on extremities and trunk and face. Approximately 15 hives all total. took infant to PMP on 10/22/01, no treatment indicated. Hives no longer in visible on 10/24/01. No further complications noted. Y Y 10/17/2001 10/21/2001 4 NONE PVT OTH NONE NONE NONE 1
0177635 11/12/2001 OK 0.3 0 .4 U On 8-28/01, at night time she acted like she was choking with her secretions. Her skin got splotchy. Acted as if she couldn't breath. Mucous from the mouth lasted 1 hour. Y Y 08/28/2001 08/28/2001 0 NONE PVT PVT Tylenol NONE NONE 1
0177636 11/12/2001 MI 0.7 0 .7 M 10/02/2001 8 month old was in exam room with older sibling who was scheduled to get shots also. Pt inadvertly given MMR. (see back) Y 09/13/2001 09/13/2001 0 NONE PVT PUB NONE NONE 1
0177637 11/12/2001 MN 0.2 0 .3 M 11/05/2001 Golf ball size swelling at shot sight of vaccines-right leg. Y 08/28/2001 08/28/2001 0 PVT PVT NONE 1
0177638 11/12/2001 OH 1.25 1 .3 M 11/05/2001 Generalized erythema, edema of left upper arm from slhoulder to elbow which is painless and has full range of motion. Y 10/31/2001 11/01/2001 1 PVT PVT NONE NONE 1
0177639 11/12/2001 WI 0.75 0 .8 F 11/01/2001 Vomiting after each feeding for one week. Diet gradually advanced from clear liquids to bland solids. Vomiting resolved. Y 10/10/2001 10/10/2001 0 NONE PVT PVT Children's Tylenol NONE 1
0177640 11/12/2001 TN 1.0 1 .0 F 10/22/2001 On 10-17-01 grandmother reports fever of 103.6 then rash developed - red, raised. Rash worsened over time and when in heat. Took to ER for evaluation, unsure if vaccine RX or 3 day measles. Rash and fever still present. Y U 10/03/2001 10/17/2001 14 Unknown PUB OTH NONE NONE NONE TN01055 1
0177641 11/12/2001 NJ 62.0 62 F 10/02/2001 Two months after shot knees swelled up and was unable to walk without severe pain. Went to orthopedic doctor and physical therapy. Received a shot of cortisone. Pain still persists. Doctor mentioned that not enough arthritis to warrant my symptoms. N 05/11/2000 X ray and MRI no results given. PVT PVT Celebrex, Prempro, Amitryptyline NONE Back pain and Fibrositis 1
0177642 11/12/2001 NJ 66.0 66 M 11/02/2001 Given a series of 3 lyme vaccines from 5/00 till 5/01. complaints of persistent muscle muscle, and joint pain. U 05/14/2001 06/16/2001 33 PVT PVT Lescol 20 mg 1
0177643 11/12/2001 OH 2.0 2 .1 M 11/05/2001 Local reaction to DTaP. Redness and swelling of left thigh measuring 6 cm by 8 cm. Onset of symptoms began 10/31/2001. Child was evaluated on 11/02/2001 for local reaction. Still has redness on 11/05/2001. Y 10/31/2001 10/31/2001 0 NONE PVT OTH NONE Clear nasal discharge 1
0177644 11/12/2001 MO 16.0 16 F 11/05/2001 Received a Hepatitis B shot today first of series. Got shot at 9:30 am, began feeling "funny" around 10 am. After lunch she used Albuterol inhaler, but has progressively became more short of breath. Now cannot converse due to shortness of breath. Brought in by school RN. SOB and wheezing. Y Y 11/02/2001 11/02/2001 0 OTH PVT NONE NONE Asthma 1
0177645 11/12/2001 FL 6.0 1 .0 M 11/05/2001 Broke out with chicken pox. Y Y 09/30/1996 11/04/2001 1861 PVT UNK 1
0177646 11/12/2001 NE 11.0 11 F 10/29/2001 Severe rash, followed by hives and 12 hours of vomiting. MD visit 10/25/2001 AM. Treatment: cortisone, liquid Benadryl, liquid Prednisone and Phenegran suppository. Mom is an RN. Y Y 10/23/2001 10/24/2001 1 NONE PUB PUB NONE Cold with sinus drainage, no temp NONE NE005 1
0177647 11/12/2001 FL 0.75 0 .8 F Rash all over body. Fever 105 F. Y 10/19/2001 10/21/2001 2 NONE PVT PVT PPD NONE NONE rash~Vaccine not specified (no brand name)~~0.00~In Patient 1
0177648 11/12/2001 OR 0.5 0 .5 F 10/29/2001 Pt 6 months old administered varicella IM instead of SC instead of HIB. Clinic RN drew up immunization. No reaction. Y 10/23/2001 10/23/2001 0 OTH PUB NONE NONE OR200141 1
0177649 11/12/2001 RI 4.0 4 F 11/05/2001 thigh swelling and hives within 24 hours of vaccine. Y 10/31/2001 10/31/2001 0 NONE OTH PUB Zyrtec Candida intertigo NONE 1
0177650 11/12/2001 MI 4.0 4 M Pt has swelling and redness locally left upper arm. Y 09/18/2001 09/21/2001 3 PVT OTH NONE NONE 1
0177651 11/12/2001 MI 1.6 1 .6 M 10/23/2001 Pt developed a rash on 10/18 described as small, light pink, bumpy rash on back, stomach and face. Pt felt warm but temperature was not measured. Rash faded and was almost gone by 10/22. On 10/23/01 pt developed runny nose and cough but rash had subsided. Mother was advised to have pt evaluated by MD. Y 10/10/2001 10/18/2001 8 PUB PUB NONE NONE NONE MI2001085 1
0177652 11/12/2001 MI 1.0 1 .1 M 10/12/2001 Pt woke on 10/12/01 with a red area on left thigh. Throughout the day, area became indurated, very dark red and is appearing to blister. Pt was to see private MD on 10/12/01. Y U 10/11/2001 10/12/2001 1 PUB PUB NONE NONE NONE MI2001083 1
0177653 11/12/2001 VA 1.0 1 .0 F 11/06/2001 Pt developed redness, warmth, erythema and pain 1-2 days after injection. Y 10/18/2001 10/19/2001 1 NONE PVT PVT NONE Sulfa allergy 1
0177654 11/12/2001 WI 53.0 53 F 11/02/2001 Pt developed cellulitis of the right arm originating from site of injection. Y Y 10/22/2001 10/24/2001 2 PVT PVT Glucovance, Clonazepam, Actos, Maxzide, Norvasc, Pravachol, Premarin, Zantac, Effexor XR, Xanax NONE Diabetes mellitus, hypertension, increased cholesterol, depression 1
0177655 11/12/2001 MA 12.0 F 11/01/2001 Pt developed induration, tenderness and swelling on left deltoid region at site of injection. U 10/29/2001 PUB PUB PPD NONE NONE 1
0177656 11/12/2001 CO 7.0 4 F 11/05/2001 Pt developed significant case of varicella, around 100 lesions, with fever. It is a breakthrough infectio, not mild. Better but not well yet. Y 09/18/1998 11/01/2001 1140 PUB PUB URI, afebrile NONE 1
0177657 11/12/2001 TX 31.0 31 M 11/03/2001 Pt received typhoid immunization in the right arm at about 08:13 hours . About 2 minutes after receiving the immunization the pt had a swelling sensation in the throat. Y 10/03/2001 10/03/2001 0 No local reaction at the injection site. Heart RRR without murmurs or gallops. Cardiac monitor NSR @ 74 SPO2 @ 92-100%, throat :WNL without submandibular lymphendnopathy. MIL MIL 50mg Benadryl NONE Pt had reaction to sodium pentathol during past surgery and quit breathing. 1
0177658 11/12/2001 NM 1.5 1 .6 M 11/02/2001 Warm, firm swollen area to increase right thigh where DTaP was given two days before. Y 10/31/2001 11/01/2001 1 OTH PUB 02001000840 1
0177659 11/12/2001 CO 10.0 10 F 11/05/2001 Right upper arm became extremely swollen and painful times 3 days which did not respond to heat or cold. Y Y 10/30/2000 10/31/2000 1 PUB PUB NONE 1
0177660 11/12/2001 OH 1.53 1 .5 F 07/19/2001 Pt was unresponsive, weak, limp, eyes dilated, jerky, jittery, trembling, fever, vomiting, earache, crying, sleepless, diarrhea, dehydrated, allergic reaction, hives,rash, and absent response, no eye contact. Y N 03/29/2001 04/01/2001 3 Virus/ unknown Hospital PUB OTH NONE NONE NONE ~DTP + Hib (no brand name)~1~0.20~Sibling 1
0177661 11/12/2001 MI 1.25 1 .3 M 11/05/2001 Generalized rash involving 2 scabbed papules at site of injection with 5 others on face, chest, and back. Y Y 10/17/2001 10/24/2001 7 NONE PVT PVT NONE NONE NONE 1
0177662 11/12/2001 IN 1.75 1 .8 M 10/31/2001 On 10/27/01 pt had a 10 minute febrile seizure and on presentation to the local ER he had a temperature of 104.7 and shortly thereafter developed a papular rash. Laboratory evaluation was performed and he was referred to local pediatrician for follow up. No previous history of febrile seizures. Y Y 10/18/2001 10/27/2001 9 CBC: 6,600 WBC, 77S 15L 5M; CXR-neg; UA:5-10WBC; 5-10 RBCs, 1-5 Epis, small bacteria, Urine culture and sensitivity no growth. BMP: WNL except glucose 153 Bun 18 Na+ 131 PUB PUB 1
0177663 11/12/2001 TN 41.0 41 F 10/12/2001 09/18/2001 Itching, went to MD. He gave medication for itching. 09/19/2001 having trouble breathing. MD gave her inhaler. 09/21/2001 still itching a little, no rash, continue to have trouble breathing. 09/24/2001 did not return call. U 09/18/2001 09/18/2001 0 UNK PUB PUB UNK Allergic to Amoxocillin. TN01053 1
0177664 11/12/2001 TN 1.0 1 .7 M 09/21/2001 Child has redness and warmth to right upper arm 09/18/2001. Saw MD 09/20/2001, fever 100, redness and warmth to right arm from shoulder to elbow and extending onto chest. Given Benadryl by MD to return to MD for recheck. Y Y 09/17/2001 09/18/2001 1 NONE PUB PUB NONE NKA TN01052 1
0177665 11/12/2001 TX 7 F LA had red rash with edema, had itching and burning. Y Y 10/23/2001 10/24/2001 1 OTH OTH NONE NONE NONE TX01165 1
0177666 11/12/2001 TX 12.0 12 M 10/29/2001 Mother reported about 15 minutes after injection pt standing, fell to floor, had jerking movement, color pale, sweating. Family called 911, paramedics stated BP low, other VS normal. Medics stated fainted did not appear to be reaction to vaccine. No other problems noted. Y 10/25/2001 10/25/2001 0 NONE PUB PUB NONE NONE NONE TX01164 1
0177667 11/12/2001 TX 4.0 4 F 10/30/2001 Leg had 8 inch by 4 inch whelp with temperature in leg, red in color. Y Y 10/23/2001 10/24/2001 1 OTH OTH NONE NONE NONE TX01163 1
0177668 11/12/2001 FL 4.0 4 F 10/05/2001 After receiving DTaP on 10/03/2001 client leg progressively became more swollen and tender. Dad brought client to clinic on 10/15/2001. MD examined left thigh which was red, hot, swollen and painful to touch. Y 10/03/2001 10/04/2001 1 NONE PUB PUB NONE NONE NONE FL0102 1
0177669 11/12/2001 KY 3.3 3 F 11/02/2001 Noticed redness/puffiness around area of shot right thigh on 11/01/2001 by parents. Shot given 10/26/2001 at HD. No other symptoms. Area of redness 2.25 inches by 2 inches. Y 10/26/2001 11/01/2001 6 NONE PUB PUB KY2001084 1
0177670 11/12/2001 TX 55.0 55 F 11/08/2001 Febrile 102, chills, lethargy, fever was 100 the second day and 99.5 on day three. Lethargy improved when fever decreased. Y 11/01/2001 11/03/2001 2 PVT PVT Maxide and Thyroid NONE 1
0177671 11/12/2001 FL 20.0 20 M 09/07/2001 Redness and swelling at injection site, warm to touch. Stated he felt abnormal; tired. 48 hours site has grown from a two inch circle to a 4 inch, with two areas streaking upwards. TX Augmentin 875 mg T BID for 10 days. Tylenol PRN for pain. Has not recovered as of 9/7/01. Y N 09/05/2001 09/05/2001 0 PUB PUB PPD/Connaught/C0150AA/ID/LFA Immunosuppression FL01028 1
0177672 11/12/2001 OH 61.0 61 F 11/09/2001 Severe swelling, redness, very hot at site, 6 red lumps, arm stiffness for 3 days, size of symptoms increased in size to 19.5 mm on 11/05/2001 (right humerous). Y Y 11/02/2001 11/02/2001 0 PVT PVT Levoxyl NONE Allergic to TB Mantoux and Tenanus 1
0177673 11/12/2001 CA 0.7 0 .7 M 11/05/2001 High fever of 104F with vomiting and URI symptoms. This occurred 1 day after F/u vaccine administered. Has had fever for three days. Seen Monday 11-5-01, afebrile. Y Y 11/01/2001 11/02/2001 1 NONE PVT PVT PPD/Aventis/C0866AB/RFA/0 previously NONE NONE 1
0177675 11/13/2001 OR U 11/09/2001 On an unspecified date, the child received an injection of DTPA; it was not reported if the child had received prior injections of DTPA. An unspecified time, post vax, the child developed stridor. It was not known if the child received medical attention. It was reported that the child did not die. No further information was available at the date of this report. U OTH OTH 20010265261 1
0177676 11/13/2001 NJ 33.0 33 M 11/09/2001 Fatigue, weight gain, pain in feet upon awakening, flu-symptoms, fever and sore throat. The annual follow up received on 7/17/03 states, "since vaccie I have suffered with chronic fatigue and over the years I've developed severe joint pain in both feet and now my knees. I have had nerve conduction tests done because my toes are numb. I have never had problems with my feet before the vaccine. Just recently I had MRI's confirm chronomalacia in my knees. I believe I probably have rheumatoid arthritis but no one has diagnosed that yet. I don't know why maybe because I'm 36 and RA usually occurs later, don't know." Y N 06/28/2000 09/01/2000 65 Blood-(-) nonspecific; tested (+) for Epstein-Barr PVT PVT NONE NONE NONE Aches~Lyme (LYMErix)~2~43.00~In Patient 1
0177677 11/13/2001 NJ 61.0 61 F 11/12/2001 4-5 after injection left arm from shoulder to elbow red, hot, swollen, painful to touch. Treatment: Zithromax 11/7 for cellulitis by PCP. Y Y 11/06/2001 11/06/2001 0 PVT PVT Paranate, Synthroid, Xanax and Restoril. NONE Hypothyroidism, mild sys. lupu, precancer of stomach 1
0177678 11/13/2001 TN 74.0 74 F 11/02/2001 Received pneumonia vaccine 10/31/2001 in AM. By that same evening, noticed swelling at injection site. Swelling increase to elbow joint. Called doctor's office on Friday. Assessment of edema. Recommended ice, elevation and Benadryl. Y 10/31/2001 10/31/2001 0 PVT PVT Prevachol, Actonel, ASA, Xanax, Serzone and Glucosamine. NONE COPD, Hyperlipidemia, Osteoporosis, Post-menopausal, allergic to codeine. 1
0177679 11/13/2001 CA 8.0 8 M 11/08/2001 Hives 6 hours after shot. Y Y 11/08/2001 11/08/2001 0 PVT OTH Amoxicillin Pneumonia NONE 1
0177687 11/14/2001 NV 2.0 2 .9 F 11/09/2001 A nurse reported that a 35 month old female received an injection of Prevnar on 8/23/01. The pt had a runny nose at the time of vaccination. On the same day, the pt experienced a fever, runny nose, was not eating and was noted to have cried "all night". She also developed redness on her arm. The pt experienced these same symptoms after receiving another dose of Prevnar on 10/23/01, see HQ8094306NOV2001. The pt recovered following treatment with Benadryl. The reporter considered these events to be "Medically Important". Y 08/23/2001 08/23/2001 0 UNK OTH OTH Augmentin; Rondec DM runny nose HQ8068606NOV2001 1
0177688 11/14/2001 NV 3.0 3 F 11/09/2001 A nurse reported that a 3 year old female received an injection of Prevnar on 10/23/01. The pt had a runny nose at the time of vaccination. On the same day, post vax, the pt experienced a fever, runny nose, was not eating and was noted to have cried "all night". She also developed redness on her arm. It was noted that the pt experienced these same symptoms after receiving a dose of Prevnar on 8/23/01, see HQ8068606NOV2001. The pt recovered after being treated with Benadryl. The events were considered to be "Medically Important" by the reporter. Follow up information received on 12/13/01 from the original reporter that clarified the patient's birth weight and number of siblings. The events required a visit to the doctor's office. Y Y 10/23/2001 10/23/2001 0 UNK OTH OTH Augmentin runny nose Fever, runny nose, not eating, cried~Pneumo (Prevnar)~~2.00~In Patient HQ8094306NOV2001 1
0177690 11/14/2001 MD 3.0 1 .3 M 11/13/2001 Onset of Autism about 5 weeks after MMR shot was given on 10/5/99. 60 day follow up on 07/28/03: "Patient did not recover from adverse event. 'Patient is still severly autistic!'" Y N 10/05/1999 03/15/2000 162 PVT PVT NONE Viral meningitis at 2 weeks of age-cured 1
0177691 11/14/2001 OK 33.0 32 M 11/05/2001 Five months after receiving his 5th Anthrax injection, the patient had a seizure during which he stopped breathing and had to be taken to the hospital by paramedics. The patient is currently being followed by MD at the VA and a neurologist. Y Y 08/12/2000 01/06/2001 147 Cat Scan, EEG, MMR and Spinal tap all WNL. MIL MIL NONE NONE NONE 1
0177692 11/14/2001 NJ 63.0 63 F 10/31/2001 Approximately 12 hours post vax the patient developed joint pain, muscle aches, and a mild sore throat. These symptoms resolved in 24 hours without treatment. Y 10/23/2001 10/23/2001 0 PUB PUB Insulin and anxiety medicine Bladder infection Allergies to flies, fish, PCN, tetracycline, sulfur, etc. NJ200120 1
0177693 11/14/2001 RI 2.0 2 .1 M 11/13/2001 The paitient had a fever of 103-104F lasting 3 to 4 days post vax. Y 10/31/2001 11/01/2001 1 NONE PUB PUB NONE NONE Mild eczema, elevated lead level 1
0177694 11/14/2001 GA 0.5 0 .5 M 11/13/2001 The patient presented in the office on 11/09/2001 with 2 round lesions on his right thigh, measuring 3/4" x 3/4", which were warm and swollen. The patient was diagnosed with cellulitis and a temperature of 102F. The patient was treated with Augmentin. Y Y 11/08/2001 11/09/2001 1 NONE PVT PVT NONE NONE NONE 1
0177695 11/14/2001 NJ 1.0 0 1 M 11/01/2001 The patient began to run a fever of 102.9 approximately 12 hours after the injection. The patient developed a red spot, that was warm, sore and swollen. Y 10/31/2001 10/31/2001 0 PVT PVT NONE NONE NONE NJ200122 1
0177696 11/14/2001 NJ 1.25 1 .3 M 10/29/2001 The patient developed a swollen area on his right thigh, approximately the size of a half dollar, the evening of the immunization. The area was warm and tender to touch. Y 10/17/2001 10/17/2001 0 PUB UNK Flovent and Albuterol Allergies NJ200121 1
0177700 11/15/2001 NY 26.0 26 F 11/13/2001 The day after receiving flu vax, pt felt weak and had muscle aches. On 11/6/01, pt fainted and "lost control of limbs" (arms and legs paralyzed). She was admitted to ICU. She remains in ICU at time of report. Ataxia, Dysarthria. The discharge summary states ataxia, dysarthria, paraparesis, and conversion disorder. The discharge summary states seizure disorder. Y Y N 10/16/2001 10/17/2001 1 OTH PVT Pain medication Heart condition, breast cyst, allergy 1
0177701 11/15/2001 PA 63.0 63 F 11/08/2001 A report was received from a health professional on 11/1/01, concerning a 63 year old female pt who experienced cellulitis, 2 days after receiving the FluVirin vaccine on 10/30/01. On 11/1/01, the pt experienced cellulitis of the entire right arm. The FluVirin was given in the right deltoid muscle. Therapeutic measures taken as a result of this event included Clindamycin and Diphenhydramine. The pt had not recovered at the time of this report. The reporter has assessed the relationship of the study medication to the event as possible. This was considered an "Other Important Medical Event". Y N 10/30/2001 11/01/2001 2 OTH OTH Topical estrogen patch, Clindamycin Hysterectomy, osteoarthritis, hypertension PJP2001003540 1
0177702 11/15/2001 72.0 72 M 11/08/2001 On 11/1/01, pt experienced cellulitis of the entire right arm. Therapeutic measures taken as a result of this event included prescription of clindamycin and Diphenhydramine. The pt had not recovered at the time of report. The reporter has assessed the relationship of the study medication to the event as possible. Y N 10/30/2001 11/01/2001 2 OTH OTH Lupron, Pepcid Malignant neoplasm of prostate FJP2001003550 1
0177727 11/15/2001 OR 0.5 0 .5 F 11/05/2001 Positive blood culture for pneumococcus. This is the report on the little girl I called about in October. She had had Prevnar and became ill, 2 months later with pneumococcus illness. An isolate was not available for CDC. On 11/6/01, the doctor just faxed me the form and he did put the vaccine dates on it but didn't send them in a progress report. They are: 3/20/01, Prevnar #1, right thigh lot 472548; 7/3/01, Prevnar #2, right thigh lot 473349; 8/7/01, Prevnar #3, right thigh lot 480895. I wasn't sure if I could add to his form. Y Y 08/07/2001 10/07/2001 61 Blood culture positive for pneumococcus. PVT PUB NONE OR200143 1
0177728 11/15/2001 CA 55.0 55 M 10/31/2001 USAF officer experienced dysphoria and dizziness 15 min after Flu shot. 20 year history receiving same, no problems. Resolved within hours. No problems. Y 10/30/2001 10/30/2001 0 NONE PUB MIL NONE NONE NONE 1
0177729 11/15/2001 CT 49.0 49 F 11/05/2001 Severe arm edema 8" by 6", red, hot to touch, irritation at injection site above, symptoms lasted 6 days. Y 10/31/2001 11/01/2001 1 PVT PVT NONE NONE Sulfa, PCN, Codeine, E-Mycin 1
0177730 11/15/2001 CA 30.0 40 F 11/05/2001 Flu Shot received left deltoid 10/31/2001. Spot Bandaid applied to site. Client returned to HC 11/02/2001 c/o redness, local pruritis, chest tightness has history of multiple allergies. Hydrocortisone cream to area and ice, need to see PMD ASAP. Y 10/31/2001 11/01/2001 1 OTH UNK NONE Allergy: sulfa, dust/molds, pollens and animals. 1
0177731 11/15/2001 TX 67.0 67 F 10/26/2001 10/26/2001 On day Following vaccine admin., client came to office stating that about 2 hour after injection was given, her left arm got swollen, red and very painful. She still had minimal swelling and slight redness at time. 10/30/2001 Phone call to pt who states that she's been pain free since Friday 10/26/2001 PM after she applied warm packs to arm, has very little swelling yet though no redness. Y 10/25/2001 10/25/2001 0 PUB PUB Synthroid, Zocor and Metropolol High cholestrol, HTN and Hypothyroid Iodine and perfume TX01164 1
0177732 11/15/2001 AL 54.0 54 F 10/29/2001 On 12/27/2001 between 3 and 4 PM, PT started feeling cold and feverish, had chills and elevated temperature, had "bad" headache (history of migraines given). States all joints ached. Skin felt sore. Had large area of erythema, soreness and warmth at injection site. Took OTC Tylenol and Benadryl 25mg. Y 10/26/2001 10/27/2001 1 NONE PUB PUB Premarin, Zyrtec, Celebrex, Zanaflex, Effenor, Neurotin, Solatron, Excedrin PM NONE Fibromyalgia, Arthritis, allergies to dust, tree pollen and grass pollen. AL0113 1
0177733 11/15/2001 IN 45.0 45 F 11/06/2001 Nausea, vomiting and urticarial pruritic rash on hands, legs and thorax and face. Lip swelling and erythema but no pharygial or airway obstruction. 11/01/2001 11/04/2001 3 Frequent F/U no labs PVT PVT Fosamax 70 mg weekly and Premarin 0.3 mg daily NONE Osteoporosis and estrogen replacement therapy 1
0177734 11/15/2001 WI 63.0 63 M 11/08/2001 Left arm pain, primary elbow to wrist less 24 hours after injection. Y U 11/07/2001 11/08/2001 1 Also received B12 injection in same arm. PVT UNK PCN 1
0177735 11/15/2001 PA 15.0 15 F 11/07/2001 Pt had paresthesia in right forearm, right calf, as well as right hand and foot. Began 5 minutes after injection and has progressively improved over the last 48 hours. Y Y 11/05/2001 11/05/2001 0 PVT OTH Ventolin NONE allergy to penicillins, cephlosporins, and seasonal 1
0177736 11/15/2001 PA 36.0 36 M 11/02/2001 Left arm four inches below injection site became red, warm, and sore to touch. No fever and no swelling. The reaction started approximately 8 hours post injection and peaked 24 hours after shot. Within 96 hours arm is back to normal. 10/29/2001 10/29/2001 0 UNK UNK 1
0177737 11/15/2001 PA 33.0 33 F 11/02/2001 Employee received vaccine around 10 AM. Did not notice anything wrong until following AM when looked at upper arm red 4 inches below injection site and warm. No swelling. Observed area next 4 days and each day reaction decreased until normal on Friday 11/02/2001. Y 10/29/2001 10/30/2001 1 UNK UNK 1
0177738 11/15/2001 UT 27.0 27 M 11/08/2001 C/O R arm feeling numb and tingling, B/P 140/82 - c/o body feeling "heavy", dizziness and nausea - evaluated by paramedics @ site. Symptoms resolved 6 hrs later, returned to work took Ibuprofen. Y Y 11/06/2001 11/06/2001 0 OTH OTH Zoloft NONE Allergy: erythromycin - Rx for depression 1
0177739 11/15/2001 UT 38.0 38 F 11/08/2001 Pt had drowsiness, headache, numbness of injection site. Moderate shortness of breath started 1 hour after immunization, duration 21/2 hours. Flovent inhaler and rest and Tylenol. Y 11/07/2001 11/07/2001 0 OTH OTH Proventil inhaler NONE Asthma 1
0177740 11/15/2001 TX 3.9 3 M 11/08/2001 11/05/2001 In for rev. post nasal drip and atopic dermatitis. Diagnosis/Impression: atopic child well clinically AD. Given flu vaccine after seen by MD. Mother later called from restaurant, had hives. Benadryl given. Hives had cleared by time they returned to office. Had eaten no new food, on no medications. Y Y 11/05/2001 11/05/2001 0 PVT PVT Atopic dermatitis NKDA/atopic child 1
0177741 11/15/2001 WI 74.0 74 F 10/23/2001 Pt developed morbilliform macular papular rash onset 24 hrs after Influenza vaccine. Treated with Benadryl. Y 10/22/2001 10/23/2001 1 PVT OTH NONE HTN, treated for bronchitis 9/21/01 with TMP/SMZ for 10 days 1
0177742 11/15/2001 IL 33.0 33 M 11/05/2001 Generalized itching to upper chest, rash present. Y 10/31/2001 10/31/2001 0 OTH MIL NONE NONE 1
0177743 11/15/2001 NJ 47.0 47 F 11/07/2001 Fever to 101 marked myalgia low back pain. Y Y 10/30/2001 10/31/2001 1 Labs done in ER - and do not have results. PUB PUB NONE NONE Chronic hepatitis C-controlled. 1
0177744 11/15/2001 AZ 69.0 69 F 11/07/2001 Fever times 7 days after administration of vaccine; arm red - lasted L48 degree. Y 10/26/2001 10/27/2001 1 PVT PVT 1
0177745 11/15/2001 MA 28.0 28 F 11/06/2001 Administered FluVac 0.5 ml IM. Within 2-4 minutes lost consciousness, stopped breathing, immediate administrative of .3 cc epinephrine. Transported to Hosp by Ambulance cl recovered. Without further treatment and returned home 11/01/2001. Y Y 11/01/2001 11/02/2001 1 OTH OTH NONE Exercise induced Asthma. 1
0177746 11/15/2001 KY 46.0 46 F 11/09/2001 Pt presented to health dept 11-9-01 with check out redness in right upper inner arm. Right arm consisted with edema. Pt stated 11-08-01 she had pain, redness and edema in right upper arm radiating into right axilla and elbow. T101. No redness or edema noted in right deltoid on 11-09-01. Pt stated no fever or pain in arm today 11-09-01. Pt reported on 11-07-01 that she had no constrain and ration to Flu or pneumonia shot. On 11-09-01 pt stated that she has had a pneumonia shot at Dr's office and it reacted the same way and MD told her that the shot was probably not effective and for her to get another shot. Received another pneumonia shot 12-01-98. 11/07/2001 11/08/2001 1 PUB UNK Bronchodilator inhaler COPD COPD 1
0177747 11/15/2001 VA 11.0 11 M 11/08/2001 Pt developed erythema, induration, and pain right upper arm at site of injection. Site of erythema is 10 X 12 cm. Injection was given on 11/5/01 and pt developed symptoms on 11/07/01. Also had a fever to 101 F. Expect complete recovery. Pt treated with antibiotics for presumed cellulitis. Y Y 11/05/2001 11/07/2001 2 CBC done. (I can't understand what the numbers given mean) but here goes: 14>13>288 80P11 L ------- -- 38 MIL MIL Advair asthma, eczema, allergic to molds 1
0177748 11/15/2001 NY 70.0 70 F 11/05/2001 Approximately 5 minutes after receiving vaccine, pt felt like passing out and c/o of involuntary shaking and numbness-decreased speech from numbness noted. Red area noticed around the base of throat and upper chest. No c/o SOB or dyspnea. Pt lay down on cot and BP taken. Transferred to ER. Called pt at home at 2:45 PM. Pt nervous and anxious, states she had no breakfast. Had some sips of water and resting. Husband with her. Felt better, set up on cot again felt like passing out and face was flushed. She was given Motrin, Benadryl, and epinephrine but is doing fine. to call if noticed anything at all happening. Not to get any more flu shots. Pt stated she had felt a rush when she had received former flu shots. Y 11/05/2001 11/05/2001 0 PUB PUB tenormin, aldactazide, NONE Allergy to Plavix and Pen V 1
0177749 11/15/2001 NH 70.0 F 11/06/2001 pt had tongue and facial swelling and hives. Was prescribed Prednisone by another MD. Y Y 10/25/2001 10/26/2001 1 NONE PVT PVT NONE Hypertension 1
0177750 11/15/2001 WA 59.0 59 F 11/05/2001 Pt had fever of 100.3 10 hrs after injection. Hives(swollen red spots size of quarter or half dollar) 24 hrs after injection. Racing heart beat and general discomfort. Muscles aches 10 hrs after injection. Y Y 11/04/2001 11/04/2001 0 NONE OTH PVT Levoxyl NONE NONE 1
0177751 11/15/2001 IN 54.0 54 F 11/06/2001 On 10/31/01 very sore arm, swelling lymph nodes. On 11/01/01 large hives, continued swelling and swelling and soreness. On 11/02/01 Dr appt and he prescribed Benadryl, cold packs. On 11/03/01 symptoms gone. Y Y 10/30/2001 10/31/2001 1 OTH OTH Synthroid, Relafen NONE NONE 1
0177752 11/15/2001 MD 5.0 5 M 11/01/2001 Received fluvax on 10/31/01, child returned home from school on 11/1/01 stating left arm had been itching at school all day. Left deltoid was reddened, itching, and warm to touch. Advised pt to apply cool compress to site, and Benadryl as needed. Y 10/31/2001 11/01/2001 1 NONE PVT OTH Albuterol, Intal, Flovent Asthma NKDA 1
0177753 11/15/2001 HI 27.0 27 F 11/02/2001 Presented 12 post vaccination with symptoms of fever, chills, nausea of 4 days duration, swollen neck glands for 2 days. Treated symptomatically with Tylenol and fluids. Returned 3 days later with persistent symptoms of fever, chills, neck and body aches, and swollen glands. Y Y 09/26/2001 10/04/2001 8 Influenza A/B antigen screen-negative and respiratory virus culture results pending. Rubeola antibody titer done on 8/13/01 and results 0.62-negative. OTH OTH Albuterol, Claritin, Advair, Desogen NONE Asthma 1
0177754 11/15/2001 AZ 64.0 64 M 11/06/2001 Nausea followed by flu like symptoms. Y 10/31/2001 10/31/2001 0 NONE OTH OTH NONE NONE NONE 1
0177755 11/15/2001 DC 69.0 69 F 11/07/2001 Erythema noted at injection site. Rx Claritin 10 x 3-9 days with relief. Y 10/29/2001 PVT PVT NONE 1
0177756 11/15/2001 KY 41.0 41 F Swollen, red, and hot at injection site. No treatment. Injection at 10:00 and had a reaction at 16:00 on the day of injection. Y 11/02/2001 11/02/2001 0 NONE OTH OTH NONE NONE Latex allergy, depression, back problems, food allergies, 1
0177757 11/15/2001 NH 52.0 52 F 11/13/2001 Post vax, the patient experienced a sore throat, rhinitis, a fever, and muscle and joint pain for 5 days. The injection site became sore, red and elevated for 24 hours once the cold symptoms were treated 6 days post vax. Y 10/30/2001 11/05/2001 6 PUB PUB Cozaar, Norvasc and ASA NONE Angina and Hypertension NH0123 1
0177758 11/15/2001 CA 24.0 24 F 10/29/2001 Post vax, the patient experienced facial flushing and palpitations. Y Y 10/29/2001 10/29/2001 0 NONE PVT UNK NONE NONE 1
0177759 11/15/2001 CA 51.0 51 F The patient complained of dizziness, nausea and "not thinking clearly" within 24 hours of receiving the flu vaccination. The patient denies a fever, vomiting or loss of consciousness. N 11/13/2001 11/14/2001 1 OTH PUB HCTZ and Lotensin NONE High blood pressure and a history of congestive heart failure. 1
0177760 11/15/2001 TX 57.0 57 F 11/14/2001 After receiving the vaccination on 11/01/2001 the patient experienced redness, pain and swelling in the left upper arm. Then 2 or 3 days later the patient developed welts on her chest. When the patient returned to the Dr on 11/05/2001 she was diagnosed with shingles. U 11/01/2001 11/03/2001 2 Shingle culture - positive PVT PVT Inderal, Intal, Beconase, Premarin, Proventil, Atarax and Duratuss Hypertension and DDD Allergic to Sulfa, Biaxin and Donnatal. Hypertension, migraine, asthma, GERD and DDD. 1
0177761 11/15/2001 MD 52.0 51 F 02/14/2003 This report A0354931A (formerly 2001026860-1) describes swelling of the hands and feet of a pt who received Lyme disease vaccine. This report has been verified by a physician. Medical history included testing positive for Lyme disease in 1999. The pt received her 1st injection of LYMErix on 10/15/2000; she had no adverse event following this injection. She received her 2nd second injection on 11/20/2000. In 01/2001,reported that she began to experience aching in all her joints. She reported that none of her joints were swollen or warm. She also experienced swelling and tingling in her hands and feet. She was seen by her Dr in Feb 2001. Multiple lab test were performed. The pt reported by June 2001, the tingling in her hand and feet had subsided and the swelling of her hands and feet was markedly decreased. The aching in her joints continued, with no decrease in intensity. With the onset of colder temperatures in the fall of 2001, all symptoms have returned to the same degree as the were in February 2001. The pt declined the 3rd injection of LYMErix. the adverse events aching joints and tingling hands and feet do not meet ICH serious criteria, but are being submitted as an expected report by special FDA request per the June 28, 2000 letter. The most recent information received from the physician on 6/20/02, indicated that the events were ongoing. The physician considered the events to be moderate-to-severe in intensity and possibly related to LYMErix administration. The adverse events of "osteoarthrtiis" and "paresthesia" do not meet serious criteria, but are being submitted as an expedited report by special FDA request per the 6/28/00 letter. Y N 11/20/2000 01/01/2001 42 Tested positive for Lyme's disease in 1999. Tested for rheumatoid arthritis and Lupus but all other lab test negative. Antinuclear antibody-negative; C-Reactive Protein <1mg/dL; Erythrocyte Sedimentation Rate-13mm/hr; Rheumatoid factor-negative. PVT OTH Hydrocodone,Wellbutrin, clonazepam, Femhrt, Relafen, Fluvastatin sodium Depression, HTN, Increased cholesterol, osteoarthritis in lower back, rotator cuff surgery, A0354931A 1
0177762 11/15/2001 NH 0.3 0 .3 F 11/14/2001 The patient experienced inconsolable crying beginning 2 hours after the immunization and lasting for approximately 1 hour. The patient was treated with Tylenol and Motrin. U 11/13/2001 11/13/2001 0 PVT PUB Inconsolable crying~DTaP (no brand name)~1~0.00~In Patient NH0124 1
0177763 11/15/2001 WI 0.1 0 .2 F 11/07/2001 Post vax the patient experienced high pitched, unusual crying that lasted more than 4 hours. Y 11/02/2001 11/02/2001 0 NONE PVT PVT 1
0177764 11/15/2001 LA 1.0 0 .8 F 10/30/2001 About 8 hours post vax the patient developed red spots on her thighs, feet, hands, neck and the back of her head. The patient was seen in the ER and diagnosed with a hand and foot disease. Approximately 10 hours later the red spots were welts the size of pennies. The patient was seen at the Women's and Children's ER and was diagnosed as having a reaction to the vaccination. The patient was treated with Clemastine. Y Y 07/26/2001 07/26/2001 0 NONE PVT PUB NONE NONE NONE LA011102 1
0177765 11/15/2001 OK 42.0 42 F 11/08/2001 Within 2 hours of receiving the injection the patient experienced swelling, redness, itching and was warm to touch with a temperature of 101F. The patient was treated with a steroid injection and antibiotics for an acute inflammatory reaction. Y 11/05/2001 11/05/2001 0 UNK UNK Allergic to Morphine and Lortab. Diabetes, hypertension and born with 1 kidney. 1
0177766 11/15/2001 CA 4.0 4 M 10/13/2001 Post vax, the patinet experienced local erythema, warmth and swelling. The patient likely had cellulitis. Y U 10/11/2001 10/13/2001 2 NONE PUB UNK URI NONE 1
0177767 11/15/2001 AL 0.5 0 .5 F 11/14/2001 The patient experienced a temperature of 101.4F within 24 hours after receiving the vaccinations. The patient's temperature was still elevated 48 hours later. U 11/12/2001 11/13/2001 1 PVT PVT Palgic D NONE Colic, eczema. hyperactive airway disease and allergies. 1
0177768 11/15/2001 NH 71.0 71 F 11/07/2001 The patient states that the day following the vaccination, she experienced some slight nausea and chills. Within 2 days her face became red, swollen and itchy. The patient's ear lobes and complete bilateral ears became red and swollen after 1 week. The patient was treated with Prednisone. Y N 10/29/2001 10/30/2001 1 SGOT = 45, SGPT = 61, Alk Phos = 114, HCT = 37.5, HGB = 13.7, RBC = 4.27, WBC = 9.9, Platelets = 214, Sed rate = 68. PVT PVT Hydrochlorothiazide, Serevent inhaler, Albuterol inhaler. NONE NKDA, hypertension, asthma and hypercholesterolemia. 1
0177769 11/15/2001 IN 73.0 73 F 11/01/2001 Post vax, the patient experienced a local reaction of her left upper arm. The patient's upper arm was hot, red and swollen. The patient was treated wtih Z-pak and Zyrtec. U 10/30/2001 10/31/2001 1 PVT UNK Allergic to Ciclor. 1
0177770 11/15/2001 MS 1.9 1 .9 M 11/05/2001 The patient's mother called to report the patient had a fever of 103F and a light rash all over. U 10/11/2001 10/18/2001 7 PVT PVT NONE NONE NONE 1
0177771 11/15/2001 MD 1.1 1 .1 F 11/07/2001 The patient has Varicella. Follow up on 12/10/2001: " Y Y 10/10/1997 11/05/2001 1487 PVT PVT NONE NONE NONE 1
0177772 11/15/2001 MA 1.5 1 .5 F 11/07/2001 The patient experienced a fever shortly after the vaccines were administered. The patient began vomiting during the night through 11/01/2001, with the worst day being 10/31/2001. The patient's fever continued through 11/02/2001. The patient has a history of fever reaction with prior DTaP's. The mother states this reaction was the most severe. Y Y 10/29/2001 10/29/2001 0 PVT PUB NONE 1
0177773 11/15/2001 84.0 F Right arm erythema from deltoid to below elbow. Y Y 10/16/2001 UNK UNK 1
0177774 11/15/2001 IN 1.0 1 .0 M 11/03/2001 The patient experienced a high temperature the day of the vaccination which increased. The patient experienced a rash about 10 days later. Y Y 09/10/2001 09/10/2001 0 PUB OTH NONE NONE NONE 1
0177775 11/15/2001 FL 4.0 4 M 11/03/2001 The patient experienced swelling of the left thigh with associated redness and tenderness, extending from the knee to the upper thigh, where the DTaP was given. The patient was treated with ibuprofen and diphenhydramine. Y 11/01/2001 11/02/2001 1 NONE PVT PVT NONE NONE NONE 1
0177776 11/15/2001 VA 1.0 1 .0 M 11/07/2001 The patient developed chicken pox lesions 11/06/2001. Y Y 03/13/1998 11/07/2001 1335 NONE PVT PVT NONE NONE NONE 1
0177777 11/15/2001 CA 1.5 1 .3 F 11/08/2001 The patient developed a fever 5 days after the vaccines were given. Y 08/10/2001 08/15/2001 5 NONE PVT PVT NONE NONE 1
0177778 11/15/2001 TX 38.0 38 F 10/16/2001 Post vax, the patient had a local reaction. The patient was treated with Benadryl and ice packs for 5 days. Y 08/06/2001 08/08/2001 2 PVT PVT 1
0177779 11/15/2001 OH 4.0 4 F 11/08/2001 The patient experienced swelling and redness around the injection site. The affected area was 4"x6". Y 10/12/2001 10/14/2001 2 NONE PVT UNK NONE NONE NONE 1
0177780 11/15/2001 RI 45.0 45 F 11/08/2001 The patient experienced swelling and pain of the left deltoid with limited range of motion of the left shoulder because of severe pain. Y U 11/07/2001 11/07/2001 0 PVT PVT NONE Allergic to Naprosyn. 1
0177781 11/15/2001 NY F 11/08/2001 The patient's right deltoid was red, warm and indurated in an area 3"x3 1/2". The patient did not have a fever or shortness of breath. Myalgias and arthralgias were present. The patient was treated with Medrol. N 11/05/2001 11/07/2001 2 PVT UNK Allergic to Sulfa, Augmentin and IV dye. 1
0177782 11/15/2001 WI 11.0 11 F 11/08/2001 11/06/2001 at 10:30 pm the patient developed hives on her abdomen, neck, back, arm, and legs. The vaccine area was not affected. The patient was treated with Benadryl. Y 11/06/2001 11/06/2001 0 NONE OTH PUB NONE NONE Allergic to penicillin. 1
0177783 11/15/2001 DC 37.0 37 M 11/08/2001 The patient developed hepatitis with jaundice on 09/21/2001. The patient had an abnormal liver function test on 10/12/2001. U 09/14/2001 09/21/2001 7 On 10/15/01 Hepatitis A-positive, CMV-positive; SGOT-over 100 PVT PVT NONE 1
0177784 11/15/2001 LA 5.0 5 M 10/30/2001 The patient developed a swollen right upper arm immediately after the injections. The patient's arm got worse the next day. The patient was seen in the ER and treated with Keflex for 10 days. Y Y 10/25/2001 10/25/2001 0 PUB PUB NONE NONE NONE LA011101 1
0177785 11/15/2001 WI 1.25 1 .2 M 10/23/2001 On 10/12/2001 redness, swelling and tenderness was noted at the injection site. The patient had a temperature of 100F. The fever lasted 1 day. On 10/18/2001 the patient's temperature was 101.5F and he developed a swollen lymph node in the groin. This temperature lasted 3 days. The patient was seen by the Dr on 10/19/2001 and was treated with Tylenol. On 10/20/2001 the patient's temperature was 101F, there was swelling of the lymph glands in the neck and groin, and the patient had a rash all over. On 10/21/2001 the rash was gone and on 10/22/2001 the patient was feeling better. Y Y 10/11/2001 10/18/2001 7 NONE PUB PUB Albuterol NONE Asthma WI0135 1
0177786 11/15/2001 WI 11.0 11 F 10/23/2001 When the patient awoke on 10/18/2001 she had a small raised rash on her forehead. The rash progressed to her cheeks and neck throughout the day. The Dr diagnosed the patient with a reaction to the Hepatitis B vaccine. The patient was treated with Claritin for 12 days and topical Benadryl with relief of the rash. The patient was advised to use no new creams, cleansers or makeup on her face. Y 10/17/2001 10/18/2001 1 PUB PUB NONE WI0134 1
0177787 11/15/2001 WI 3.0 3 M 09/06/2001 At lunch time the patient indicated he had pain in his left arm. The patient's mother noted his arm was red. The patient was seen in the Public Health Office and was noted to have a 30mm non-tender, soft, warm to touch red area on the back of his left arm. On 09/17/2001 the patient's father advised everything is OK now. Y 09/05/2001 09/06/2001 1 PUB PUB NONE NONE Allergies and asthma. WI0133 1
0177788 11/15/2001 WI 5.0 5 F 07/12/2001 The patient had a seizure on 03/14/2001 that lasted 3 minutes. The patient did not have a fever prior to the seizure. The patient had several seizures on the following days. The seizures were petit mal. The patient was started on Depakote on 04/13/2001. Y Y 02/15/2001 03/14/2001 27 CT Scan = Normal, EEG on 03/28/2001 abnormal. PUB PUB NONE NONE NONE WI0132 1
0177789 11/15/2001 SC 12.0 12 F 11/01/2001 The patient states she noted a red bump that looked like a mosquito bite on 10/13. The patient was seen in the ER on 10/27 and advised the bump was probably due to the vaccine. The patient was treated with Elocon cream. The patient now has a rash on her trunk and neck after changing detergent. The child was seen by the Dr and told she has probable ringworm. The patient was advised to use Lotrim AF. There was a 14mm x 13mm sized open patch noted on the patient's left arm. Y U 10/04/2001 10/13/2001 9 OTH PUB SC0154 1
0177790 11/15/2001 MI 13.0 13 M 11/03/2001 30 to 60 seconds after the vaccine the patient fainted and was laid on the floor. The patient came to 5 seconds later. The patient laid down for 5 minutes and stated she felt better. The patient's skin was pink and dry. The patient had emesis and pale skin color. The patient laid down for 15 minutes and then had no problems. The patient was sent home with her mother. Y 11/03/2001 11/03/2001 0 PUB OTH NONE NONE Allergic to amoxicillin. 1
0177791 11/15/2001 U 11/02/2001 Caller stated that a male pt was inadvertently administered an expired (8/2001) dose of PNE-IMUNE23. The pt developed a local reaction of redness and swelling and pain. Pt was unable to sleep all night due to the pain. Additionally while reading the pt chart it was discovered that this pt had already received a dose of PNU-IMUNE-23 in January 2001. Field Alert being issued for a medication error that resulted in an adverse event. U UNK UNK 1
0177792 11/15/2001 FL 0.2 0 .2 F In response to DTaP the child experienced high pitched screaming from AM to PM. The patient will be given DT only in the future. Y Y 11/12/2001 11/12/2001 0 PVT OTH NONE NONE NONE 1
0177793 11/15/2001 TX 4.0 4 M 11/02/2001 24 hours after the vaccines were administered, the patient developed swelling, redness and warmth. Y Y 10/29/2001 10/31/2001 2 NONE PVT PVT NONE NONE NONE 1
0177794 11/15/2001 TX 0.2 0 .2 F The patient experienced constant crying, red blotches on her chest, is not eating and is fussy. Y Y 11/01/2001 11/01/2001 0 PVT UNK NONE NONE TX01165 1
0177882 11/15/2001 MA 1.5 1 .5 F 11/10/2001 Swollen, red, warm upper left arm where 2 immunizations given less than 24 hours ago. Told to apply ice to area, give 1 tsp Motrin TID, return if worse and avoid IPV and pertussis in future (should get DT only). Y 11/09/2001 11/10/2001 1 PVT PUB NONE NONE 1
0177705 11/16/2001 FL 71.0 71 M 11/07/2001 Pt expired at 11:30 AM on 11/3/01. Death certificate states cause of death as cardiopulmonary arrest due to congestive heart failure. Other significant conditions noted were endstage cardiomyopathy and IDDM. Cause of Death as per Death Certificate was cardiopulmonary arrest. Y 11/03/2001 N 10/31/2001 11/03/2001 3 PVT PVT End stage cardiomyopathy; chronic atrial fibrillation; IDDM; renal insufficiency 1
0177706 11/16/2001 FL 0.2 0 .2 M 11/08/2001 Death (Pt had 1st Hep-B/5194A2/IM/RL on 7/31/01). COD as per autopsy report: Complications of acute upper and lower respiratory tract infections/sr Y 10/16/2001 N 10/08/2001 10/16/2001 8 Autopsy PVT PVT NONE NONE 1
0177707 11/16/2001 NY 0.2 0 .2 F 11/08/2001 The baby was well on the morning of 10/16/01. She was taken to the babysitter's house. Father picked up the baby in the afternoon of 10/16/01 to find the baby in moribund state. He rushed the baby to the ER. All resuscitation efforts failed. Baby referred to medical examiner's office. Cause of Death as per autopsy report was SIDS Y 10/16/2001 N 10/11/2001 10/16/2001 5 PVT PVT NONE NONE 1
0177708 11/16/2001 61.0 61 M 11/14/2001 The pt was institutionalized in a nursing home and received a Flurvirin injection on 11/5/01. The next evening, the pt complained of chest pain and right hand pain. He was given sublingual nitroglycerin with marginal relief and experienced increasing shortness of breath. Subsequently, the pt was transported to the hospital and was pronounced dead upon arrival on 11/6/01. The reporter stated that the pt may have experienced a massive myocardial infarction. The reporter has assessed the relationship of study medication to the event as unknown. Death certificate states cause of death to be coronary artery disease. Y 11/06/2001 N 11/05/2001 11/06/2001 1 OTH OTH Aspirin; Cardura; Cardizem; Vasotec; Effexor; Imdur; Lopressor; Plavix; Prevacid;Trazadone; Nitroglycerin; Tylenol; Zantac Hemiparesis due to CVA CVA with hemiparesis; hypertension and coronary bypass surgery PJP2001003870 1
0177715 11/16/2001 HI 0.2 0 .2 M 11/08/2001 Pt developed a febrile seizure. He was treated for fever control and hospitalized for observation. Y Y 1 Y 09/25/2001 09/25/2001 0 PVT PVT 1
0177716 11/16/2001 OK 1.2 1 .0 F 11/02/2001 Pt began having seizures 1 week after 6 month vax. The condition worsened about 4 months later (increased frequency of seizures and pt was hospitalized). Pt was stable on medication and then had vax on 8/31/01 and began having uncontrollable seizures and right sided weakness. Y 2 Y N 08/31/2001 09/04/2001 4 Milk allergy PVT PVT MRI- normal ? Seizures~DTaP (Infanrix)~3~0.00~In Patient 1
0177717 11/16/2001 ME 52.0 52 F Alopecia, fibromyalgia, chronic fatigue, thyroiditis, vasculitis. Other vaccines given were Hep B 6/99 and Tetanus 5/99 unknown manufacturer/lot number. Per 1 year follow up: Pt did not recover. Symptoms all described in earlier VAERS submission. Y N 10/01/1999 12/01/1999 61 CRP 9.2; IgG and IgM levels increased PVT PVT NONE NONE 1
0177718 11/16/2001 WI 2.0 2 1 M 11/07/2001 Pt developed idiopathic thrombocytopenic purpura. He presented with sudden onset of petechiae. Y 1 Y 10/09/2001 11/03/2001 25 Platelet 9,000 decreased to 3000 than 26,000. PVT PVT NONE NONE 1
0177719 11/16/2001 PA 42.0 42 M 10/12/2001 Pt developed moderate to severe pain in the left shoulder joint radiating to the elbow. Pt treated with pain medication and physical therapy. Y Y Y U 04/17/1996 02/24/1999 1043 X-ray, MRI shoulder, MRA neck-no peculiarities PVT PVT 1
0177720 11/16/2001 NC 0.08 0 .1 F 11/07/2001 Pt became limp and was not breathing for about 1 minute. She was very pale and slightly foaming at the mouth. Mother did mouth to mouth, but pt still did not breathe for about 1 minute. Mother called 911. Pt was ok when EMS arrived. Pt was taken to ER by EMS and admitted by MD. Y 1 Y 11/06/2001 11/06/2001 0 CBC (WNL), BL cx (-), RSV (-), EEG (WNL), Monitored 24 hrs - d/c 11/8/01 in good condition. PVT PUB Slight congestion NONE 1
0177721 11/16/2001 CT 28.0 28 F 11/09/2001 Pt developed chronic joint pain since 10 days after first LYMErix injection which was 8/19/99. Pt has had pain starting in lower back (sacroiliac joints) and radiating down throughout entire pelvic area. Pt has seen numerous doctors and taken many meds and had several tests done. Pt had second and third doses of LYMErix on 9/20/99 and 10/20/99. Doc 208124 states that patient has very bad chronic joint pain in entire pelvic area and is constantly uncomfortable especially when sitting. Per 60 day follow up: Pt did not recover. Pt continues to have chronic pain in lower back and entire pelvic area. Pt have seen numerous doctors and taken many medications and nothing has helped th eproblem at all. Pt is positive that this problem is a direct result from the vaccine and have seen physicians who confirm it. Please let me know if you need any further info. Y N 08/19/1999 08/29/1999 10 x-rays, bone scan of pelvis, MRI and blood work. Results came back normal but pain has continued to worsen. Pt rec'd Lymerix #2 9/20/99, and # 3 10/20/99. PVT OTH Asthma, chronic sinus problems, allergies 1
0177722 11/16/2001 NM 2.5 2 .7 M 11/07/2001 Had vaccination, then went home & napped. upon awakening he started to walk then fell over was dizzy and very unsteady on feet. No other neurological changes noted. Brought to hospital ER. Had oral ibuprofen at 5pm for leg pain. Y Y 2 Y 11/05/2001 11/05/2001 0 WBC-4.4; CT head, MRI head, all other blood work, throat culture, urine tox screen and urinalysis-all wnl PVT PUB NONE NONE Chronic OM with PET placement 12/5/00 1
0177724 11/16/2001 UT 1.0 1 .0 M 11/07/2001 Twenty four hours post vax, pt experienced a febrile seizure. His temperature was 102F. Forty eight hours post vax, pt had a second febrile seizure. Y Y 1 Y 10/31/2001 11/01/2001 1 CBC, UA, chest x-ray, blood and urine cultures-all wnl PVT PVT Otitis media, upper respiratory infection 1
0177725 11/16/2001 MA 47.0 47 F 11/07/2001 Pt developed severe hives, itching and redness all over body. She had hoarseness and fast heartbeat. Benadryl was administered after 8 hours. Y Y 10/16/2001 10/18/2001 2 PVT PVT Celexa, Motrin, Darvocet-N NONE Fibroids, headaches, high cholesterol 1
0177726 11/16/2001 IL 1.2 M 11/03/2001 Pt developed high fever and had generalized tonic-clonic convulsions witnessed by a nurse in ER on 10/30/2001. Y 3 Y 10/30/2001 10/30/2001 0 CBC, blood culture, spinal tap, CSF cultures, CT scan and EEG PVT PUB NONE 1
0177795 11/16/2001 KY 46.0 40 F 11/09/2001 The patient states that every time she has gotten a flu vaccine since 1996 the same thing happens a few days later; the end of her nose gets red and swollen, one or two days later the skin has clear liquid beneath it which drips out and the skin comes off a couple of days later when she washes her face. The area stays raw and bleeds every time it is touched for up to 2 months before it finally heals. The dermatologist diagnosed the lesion as a brown recluse spider bite. Y Y 01/04/1996 01/04/1996 0 PUB PUB Allergic to outdoor molds, penicillin, rabbits, walnuts and nickle. 1
0177796 11/16/2001 ME 54.0 54 M 10/15/2001 The patient has stomach cramps, diarrhea and sweats. The patient was treating this with Tums. Y 10/02/2001 10/02/2001 0 NONE OTH OTH Eye drops - FMC NONE 1
0177797 11/16/2001 MI 43.0 43 F 11/07/2001 The patient developed a rash. U 11/01/2001 11/07/2001 6 PVT UNK NONE 1
0177798 11/16/2001 NY 89.0 89 M 11/02/2001 On 10/08/2001 the patient complained of redness, swelling and a burning sensation in the muscle of the left arm. The patient was seen on 10/09/2001 and diagnosed with cellulitis. The patient was treated with Levaquin for 10 days. Y 10/03/2001 10/08/2001 5 NONE PVT PVT Prilosec, Paxil, Lasix, digoxin, ASA, KOVR, Axid, Amitriptyline and Procrit NONE CAD with CHF, anticoagulation, DJD, GERD, depression and PVD 1
0177799 11/16/2001 NY 77.0 77 M 11/02/2001 10/11/2001 the patient was seen at the Dr's office for tenderness and pain at the injection site with associated redness and swelling. The symptoms were noted within 2 hours after receiving the injection. The patient was treated with Levaquin for 5 days. Y 10/09/2001 10/09/2001 0 NONE PVT PVT Ambien, Nexium, ASA, Tricor, folic acid, Toprol XL, Arthripower and Mycelex. Oral candidiasis CAD, Hyperlipidemia and GERD 1
0177800 11/16/2001 TX 0.2 0 .2 F 11/05/2001 Wheezing with breath (every 8 seconds) causing whole body to shake. Y Y 09/19/2001 09/19/2001 0 Blood normal, EEG (later) normal. PVT OTH NONE NONE Periodic breathing (premature 35 weeks) 1
0177801 11/16/2001 VT 48.0 48 F 11/09/2001 The patient felt dizzy, nauseated, nervous and was very pale. The patient rested and was reassured. Y 11/09/2001 11/09/2001 0 OTH PVT NONE 1
0177802 11/16/2001 NY 19.0 19 F 11/07/2001 Twenty minutes after receiving the flu shot the patient got hives all over her body, itched, her lips and tongue were swollen and she was very shaky. She did not have any shortness of breath or wheezing. Y 11/02/2001 11/02/2001 0 PVT UNK NONE NONE 1
0177803 11/16/2001 NY 31.0 31 F 11/06/2001 Post vax the patient developed a red area at the injection site, blotches over her body, a headache, tight chest and shaking. Y Y 10/31/2001 10/31/2001 0 PVT UNK Synthroid and Effexor NONE Allergic to Novacaine, Emycin, Amoxicllin, Augmentin, Zestril and Verapamil. Diagnosed with MUP, Hypothyroid and migraines. 1
0177804 11/16/2001 PA 52.0 52 F 11/08/2001 Within 6 hours after vaccinations the patient's left arm was warm, with severe pain and difficulty raising her arm. The patient was treated with heat and Tylenol. Y 11/07/2001 11/07/2001 0 OTH PVT 1
0177805 11/16/2001 IL 35.0 35 F 11/07/2001 11/05/2001 the patient was flushed. On 11/06/2001 the patient developed malaise, redness, warmth and a raised area of the right upper arm at the injection site. 11/07/2001 the patient feels better, has an area of redness 2 1/2"x 1 1/2", slightly raised with warmth at the injection site. The patient was already on Voltaren and applied ice to site. 11/08/2001 the redness and pain had decreased. Y 11/05/2001 11/05/2001 0 NONE OTH OTH Avelide and Voltaren NONE Arm Problems 1
0177806 11/16/2001 CA 60.0 60 M 11/07/2001 The patient experienced fatigue, dizziness, muscle aches in the legs and chest, nausea, night sweats, loss of appetite, loss of weight and stomach cramps. Y 11/01/2001 11/02/2001 1 NONE OTH PVT Lipitor and glucophage NONE Diabetes Type 2 1
0177807 11/16/2001 MD 56.0 56 F 11/12/2001 The patient's legs felt numb, tingling and weak. The patient's tongue was tingling, she had back pain and her blood pressure was up. Y Y 11/09/2001 11/09/2001 0 CT Scan PUB PVT 1
0177808 11/16/2001 TN 78.0 78 F 11/07/2001 The patient's left arm had a circular, raised, erythematous patch of skin approximately 5" in diameter just below the site of injection on the left arm. The area was slightly warm to the touch. The patient was treated with Tylenol and Benadryl. The patient's symptoms resolved after 3 to 4 days. Y 10/30/2001 10/31/2001 1 OTH PVT Lozol, Pravachol, Synthroid, and Advil. NONE 1
0177809 11/16/2001 PA 63.0 63 F 11/12/2001 The patient experienced erythema, swelling, and warmth of the entire right arm within 24 hours after receiving the vaccine. This was consistent with cellulitis. The patient was treated with Clindamycin and Benadryl. Y Y 10/30/2001 10/31/2001 1 NONE PVT UNK NONE Allergic to penicillin. Has osteoarthritis. 1
0177810 11/16/2001 PA 72.0 72 M 11/12/2001 The patient experienced erythema, swelling, and warmth of the left upper extremity within 24 hours of vaccination. The symptoms were cellulitis in nature. The patient was treated with Ceflex and Benadryl. Y Y 10/30/2001 10/31/2001 1 NONE PVT UNK NONE 1
0177811 11/16/2001 MO 49.0 49 M 11/13/2001 One week post vax, the patient experienced moderate shoulder pain. The patient had a normal clinical exam. Y 10/31/2001 11/07/2001 7 OTH PVT NONE NONE NONE 1
0177812 11/16/2001 IL 50.0 50 F 11/19/2001 Post vax the patient developed a raised bump on his arm about the size of an egg in circumference. His skin felt leathery with a slight itch and redness. Y 11/07/2001 11/08/2001 1 UNK UNK 1
0177813 11/16/2001 FL 69.0 69 F 11/01/2001 The patient complained of swelling and redness of her arm. The patient applied ice. The patient also complained of electric shocks down her arm. The patient's spouse left a message on the clinic's answering machine. Y 10/30/2001 10/30/2001 0 PVT OTH Premarin, Allegra and Nasonex Allergic to morphine. 1
0177814 11/16/2001 GA 35.0 F 11/08/2001 The day after the vaccination the patient woke up with aches and a rash. The patient was treated with Benadryl. Y 11/06/2001 11/07/2001 1 NONE UNK UNK Seroquel, Lithium, Wellbutrin and Ambien Allergic to penicillin, ASA, theophyline and PPD. 1
0177815 11/16/2001 MA 45.0 45 F 10/31/2001 The patient experienced swelling at the injection site, redness and hot to touch. The patient had a fever, swollen glands, body aches and chills. The patient was diagnosed with left nasal turbinitis, erythema, left submandibular adenitis, right submandibular adenitis, lung sounds (rales at bases); a nonproductive cough. Still treating. Y N 10/29/2001 10/29/2001 0 Chest x-ray, CBC, Sed rate PVT PVT Paxil and Tylenol. Positive for Hepatitis C - treated in 2000. 1
0177816 11/16/2001 CA 56.0 56 F 11/07/2001 Three weeks post vax, the patient's upper left arm aches and is sore. N 10/17/2001 10/20/2001 3 PUB PVT Prempro NONE NONE 1
0177817 11/16/2001 IL 30.0 30 F 10/30/2001 The patient experienced a rash, fever, severe muscle aches, sore throat, weakness and was unusually nervous. The patient had a fever, pain and high blood pressure when she was seen in the ER. The patient's temperature started at 2:00 am on 10/25/2001 and ranged from 100.6F to 102.6F and finally broke on 10/29/2001 around noon. The rash was lighter in color on Thursday and Friday after the patient began taking Benadryl. The patient was off work on Friday because she was too weak to move. When seen in the ER, the patient tested negative for strep, but the physician advised not to rule out a strep infection because the rash did not itch. Benadryl did not help the rash. The patient was on antibiotics for 4 days and the rash is disappearing. Y Y 10/24/2001 10/25/2001 1 PUB PUB Celexa, Xanax and Trazadone. UNK Depression 1
0177818 11/16/2001 AL 76.0 76 F The patient developed a reddened area at the injection site two days after the vaccination. Y U 10/03/2001 PVT UNK NONE Lipid, NIDDM, CHF. 1
0177819 11/16/2001 NC 26.0 26 M 11/05/2001 Five minutes post vax the patient started having total body itching, worst at the head and neck areas. The patient was treated with Benadryl and improved. The patient also had nausea and emesis. Y Y 11/05/2001 11/05/2001 0 NONE MIL MIL NONE NONE NONE 1
0177820 11/16/2001 3.0 U 11/14/2001 A 3-year-old was inadvertently given FluShield vaccine under the deltoid muscles, which was supposed to be given in the deltoid muscle. The area below the deltoid muscle became red and hot with a large induration on the day following the vaccination. U 11/06/2001 11/07/2001 1 UNK UNK 1
0177821 11/16/2001 NY 46.0 46 F 11/12/2001 Post vax the patient had a red raised area at the site of injection and red-swelling lesion on her arm. Y 11/07/2001 11/09/2001 2 PUB PVT NONE NONE 1
0177822 11/16/2001 NY 68.0 68 F 11/09/2001 Post vax the patient experienced extreme dizziness when she lifted her head, her eyes flickered back and forth for 2 days and then she developed high blood pressure (165/95) was (199/110) and temperature was 100F. The patient is now being treated for high blood pressure with Hyzaar. Y Y 10/30/2001 10/31/2001 1 Blood tests all normal. PUB PUB Hormone replacement. NONE NONE 1
0177823 11/16/2001 MA 56.0 56 M 11/19/2001 The patient had bilateral neck pain radiating to his head. The Health Unit was called on 11/07/2001 and advised the patient to contact his own MD and to treat with Tylenol and Motrin. U 10/31/2001 11/09/2001 9 OTH PUB NONE Asthma, diabetes and allergic to penicillin. 1
0177824 11/16/2001 VT 57.0 57 F 11/05/2001 The patient was injected with a needle on a syringe. There was no air or solution in it. Y 11/05/2001 OTH OTH UNK Allergic to Thimerosol. 1
0177825 11/16/2001 MA 51.0 51 F 11/02/2001 The patient call and reported right ear pain and numbness in the right foot. The symptoms occured at approximately 6 PM on 11/01/2001. The ear pain passed by the AM of 11/02/2001. The patient states she also has TMJ. The patient's MD was called and advised the patient if she is not better by 11/05/2001 to see him, and if it is worse over the weekend to go to the ER. U 11/01/2001 11/01/2001 0 OTH PVT 1
0177826 11/16/2001 MO 87.0 87 M 10/31/2001 The patient developed a rash around the injection site. 3 days later the patient noticed the rash had spread down his arm to his back, chest and to his right arm. The rash was solid on his right arm and neck and was scattered on all other areas. The patient experienced severe itching. The patient was seen by the doctor on 10/31/2001 and treated with a cortisone injection and medication for the itching. N 10/23/2001 10/26/2001 3 PUB PUB Isosorbide, Metoprolol, Baby ASA and Rantidine. NONE High blood pressure. MO2001057 1
0177827 11/16/2001 DE F The patient experienced a sore throat, difficulty swallowing, a minor headache, vomited once and a low grade fever. U 11/08/2001 11/08/2001 0 NONE OTH PVT NONE NONE Pregnant, 2nd trimester. 1
0177828 11/16/2001 WI 18.0 18 F 11/08/2001 The patient experienced a migraine headache, fever, stuffiness, felt hot and her head, neck and chest aches. The patient's right arm is sore at the site of injection. The patient had nausea and vomited on 11/06 and remained ill until 11/08. Y 11/05/2001 11/05/2001 0 NONE PVT OTH NONE Allergic to penicillin. 1
0177829 11/16/2001 IA 50.0 50 F 11/15/2001 The patient called and came in with complaints of redness, swelling and pain in the bicep. This began around noon Friday. Symptoms were pretty much resolved by 11/05/2001. The patient treated with Benadryl and Ibuprofen to help resolve the pain and swelling. Y 11/01/2001 11/02/2001 1 OTH PVT NONE NONE NONE 1
0177830 11/16/2001 MD 51.0 51 F 11/12/2001 The patient developed a 4cm x 7 cm erythema that was warm and slightly tender to touch. N 11/11/2001 11/12/2001 1 OTH PUB Xanax 1
0177831 11/16/2001 MD 72.0 72 F 11/12/2001 On 11/05/2001 the patient experienced swelling, erythema and pain of the injection site. On 11/06/2001 the pain increased and the patient also had shortness of breath. The patient went to the ER and was diagnosed with an allergic reaction to influenza and cellulitis. Treatment for the cellulitis was initiated. The patient show improvement with Benadryl and NSAID's. Y Y 11/05/2001 11/05/2001 0 NONE PVT PVT Accupril, Premarin, ASA, HCTZ and Lipitor. NONE Hypertension, hypercholesterolemia, hypothyroid, history CVA and GERD. 1
0177832 11/16/2001 AK 45.0 45 F 11/01/2001 At 11:40AM the patient experienced visual distortions in the left eye. She saw pulsing flashes of light whether her eyes were open or closed. The left side of whatever she looked at was obscured. The patient felt lightheaded and unsteady. The patient's blood pressure was elevated. Her vision cleared after 20 minutes. At 12:30PM the patient experienced tingling and numbness in her left hand, lips and nose. This subsided in 10 minutes. At 2:00PM the patient experienced chills, a slight fever, extreme malaise, slept 15 hours, had a sore arm and a headache. Y 10/31/2001 10/31/2001 0 MIL MIL IPPD NONE NONE 1
0177833 11/16/2001 HI 67.0 66 M 11/07/2001 The patient experienced erythema and edema on his shoulder and neck adjacent to the injection site. Y Y 10/06/2001 10/07/2001 1 PVT PVT Meclizine, Nifedipine, Singular, Ambien, Allopurinol, Prevacid, Ventolin, Zocor, ECASA and Viagra. NONE Hypertension, high cholesterol, cervical myelopathy, asthma, high uric acid, high triglycerides and allergic to Cephachlor and Vicoden. 1
0177834 11/16/2001 HI 66.0 66 F 11/06/2001 The patient experienced erythema and edema on the should and neck adjacent to the injection site. Y 10/09/2001 10/09/2001 0 PVT PVT Lopid, Fosamax and Synthroid. NONE Hypertension, decreased thyroid, osteoporosis and diverticulosis. 1
0177835 11/16/2001 NC 67.0 F 11/12/2001 On 10/17/2001 the patient complained of her left arm being red and swollen after taking the flu and pneumonia vaccines. The patient states she also ran a fever. The patient's arm was painful and tender. The patient was diagnosed with cellulitis. The patient was treated with Keflex and Diflucan. Y Y 10/15/2001 10/16/2001 1 OTH UNK Alleve NONE Arthritis of right hip. 1
0177836 11/16/2001 OH 81.0 81 F 11/07/2001 Post vax, both of the patient's arms were red. Y 10/31/2001 11/02/2001 2 PVT OTH NONE EES, sulfa, HTN, hypothyroid and hyperglycemia. 1
0177837 11/16/2001 UT 48.0 48 F 11/13/2001 The patient received the vaccination on Monday. Her symptoms began on Tuesday. The patient experienced puffy, redness around the injection site. On Thursday the patient saw the Dr and was started on Prednisone and Atarax. Sunday was her worst day, with a rash covering nearly all of her body, but heaviest around the injection site. On Tuesday the patient saw the Dr and was prescribed Prednisone, Zyrtec and Atarax. 12/17/2001 Site has nodule remaining. Y Y 11/05/2001 11/06/2001 1 OTH PVT Fluoxetine, Glucophage, Glucotrol XL, Alprazolam, Furosemide, Lortab, Flexeril and Prednisone. Diabetic and allergic to codeine, iracrolide, morphine and penicillin. 1
0177838 11/16/2001 NJ 55.0 F 11/12/2001 The patient developed a high fever, flu like symptoms, aches, nausea and sinusitis. Y PVT PVT NONE 1
0177839 11/16/2001 PA 55.0 52 M 11/04/2001 The patient experienced joint pain in the shoulders, lower back and knees. His eye sight got bad in a short period of time. The patient experienced dizziness, headaches, a rash on his stomach and hands and swelling. Y U 06/08/1999 08/01/1999 54 HLA - DR4 genetic trait, ANA Anti-nuclear antibody test. Results not in yet. PVT OTH Zoladex NONE Prostate Cancer in 1998. 1
0177840 11/16/2001 MD 59.0 56 M The patient experienced arthritis like symptoms. Y N 08/13/1999 11/05/1999 84 PVT PVT NONE NONE NONE 1
0177841 11/16/2001 MD 35.0 34 M 11/18/2001 Forty-eight hours post vax the patient experienced a localized, transient rash. Y 11/06/2001 11/08/2001 2 NONE OTH OTH NONE NONE NONE 1
0177842 11/16/2001 MD 53.0 53 M 11/08/2001 Forty-eight hours post vax, the patient experienced a transient localized rash. Y 11/06/2001 11/08/2001 2 NONE OTH OTH NONE NONE NONE 1
0177843 11/16/2001 MD 56.0 56 M 11/18/2001 Forty-eight hours post vax the patient experienced a generalized rash. Five days later the patient experienced joint swelling, pain and fever. The patient is being treated with Prednisone. Y 11/04/2001 11/06/2001 2 NONE OTH OTH NONE NONE 1
0177844 11/16/2001 CA 7.0 7 F 10/29/2001 Two days post vax the patient experienced an increase in blood glucose, received a mildly increased insulin dose. The next day the patient had a seizure associated with the blood glucose in the 50's. The seizure was generalized and brief. On arrival to the ER the patient's blood glucose was 88. No further problems or treatment. Y Y 08/30/2001 09/01/2001 2 PVT PVT Insulin NONE Type I diabetes mellitus. 1
0177845 11/16/2001 PA 0.6 0 .6 F 11/08/2001 Approximately 24 hours post vax, the patient developed a high fever that resulted in a febrile seizure. Y Y 11/06/2001 11/07/2001 1 CBC - elevated, WBC - elevated, Platelets - elevated. PVT PVT NONE NONE 1
0177846 11/16/2001 NE 1.3 1 .3 M 10/30/2001 The patient experienced a fever of 103F and irritability 24 hours post vax. The symptoms were resolved within 72 hours. Y 10/28/2001 10/29/2001 1 PVT PVT 1
0177847 11/16/2001 NC 0.2 0 .2 F 10/18/2001 The patient experienced extreme fussiness, vomiting and diarrhea a few hours after the vaccinations. The patient had a rash from head to toe the next day. Y 10/09/2001 10/09/2001 0 PVT PUB Infant Tylenol. NONE NONE NC01096 1
0177848 11/16/2001 CT 12.0 12 F 11/13/2001 The patient experienced swelling and pain of the left arm. The patient was seen in the ER and was advised to use Tylenol for the pain and cool soaks to the area. Y Y 11/06/2001 11/06/2001 0 OTH PUB CT200108 1
0177849 11/16/2001 NC 51.0 51 F 11/14/2001 The patient developed joint pain and swelling involving the hand, knees, elbows and feet within a few hours after receiving the vaccine. Pt has not recovered at the present time. Y N 10/26/2001 10/26/2001 0 Elevated ASO titer / ANA antibody OTH PUB Activella and calcium supplement. NONE Menopause 1
0177850 11/16/2001 VT 1.3 1 .3 M 11/09/2001 On 11/08/2001 the patient's mother noticed redness, swelling and warmness. The patient was seen by the Dr on 11/09/2001 and diagnosed with erythema and swelling of the left upper thigh. The patient was treated with Motrin and Benadryl. Y Y 11/07/2001 11/08/2001 1 PVT PUB Synergis Medimmune, Augmentin, Xoperex and Pulmicort. Purulent nasal discharge VT01001 1
0177851 11/16/2001 MI 41.0 F 10/16/2001 Pt rec'd tetanus shot. Had severe-pain lasted over 2 wks. Pain-left under arm (felt like shoulder out of joint) immediately after. July-woke up, felt like a shot had been given in sleep. Pain-swelling in arm. Unbearable at times, radiating to shoulder. Muscle spasms. Feels like arm is broken. 10/5/01 (nerve block) no results. Y N 04/09/2001 04/10/2001 1 Doppler, x-rays, bone scan, MRI's, blood tests, EMG PVT UNK NONE NONE NONE 1
0177852 11/16/2001 WI 66.0 66 F Approx. 24 hours, post vax, the pt's left arm became red, swollen and sore which went down her arm. She saw a physician who dx'd it as a staph infection and ordered antibiotics which resolved the symptoms. Y Y 10/24/2001 10/25/2001 1 No culture done to confirm staph PUB PVT 1
0177853 11/16/2001 NC 1.0 1 .0 M 11/07/2001 Pt developed slight erythema with a few "spots" on his right thigh. Y Y 10/26/2001 11/06/2001 11 NONE PVT PUB Tylenol NONE NONE 1
0177854 11/16/2001 SD 0.25 0 .3 M 11/08/2001 Pt awakened from nap with arching and stiffness of body, inconsolable crying for 10-15 minutes. On the evening of 10/26/01, the pt started with a very deep cough and production of clear mucous causing gagging and choking with fussiness which persisted through the week with onset of low-grade temperature on 10/31/01 and green and matting eyes. Y 10/26/2001 10/26/2001 0 PVT PUB NONE NONE 1
0177855 11/16/2001 WI 69.0 69 M Approx. 24 hours, post vax, the pt's left arm became red, swollen and sore which went down his arm. He saw a physician and was placed on antibiotics which resolved his symptoms. The physician told him that because the redness went down his arm and was not just localized, that it was a staph infection. No culture was done to confirm staph. Y Y 10/24/2001 10/25/2001 1 PUB PVT 1
0177856 11/16/2001 WV 8.0 2 .0 F 11/09/2001 Pt developed a rash for 5 days. She had about 10 lesions, raised and then blistered areas which are now crusted and itching. Y 06/26/1995 11/03/2001 2322 PVT PVT NONE NONE 1
0177857 11/16/2001 MI 4.0 4 F 10/10/2001 Pt developed a rash, 4 days post vax. It progressed to erythema multiforme and by 9/29/01 with arthralgia. It resolved by 10/4/01. Y Y 09/21/2001 09/25/2001 4 NONE PVT OTH NONE NONE At 2 years of age, had red blotches on neck and eyes treated with Neomycin eye drops. 1
0177858 11/16/2001 FL 44.0 44 F 11/05/2001 3 days, post vax, pt developed pain in left knee, calf and thigh. She took ibuprofen and other OTC arthritic medicines with slight improvement. Also tried ice and heat. She denies any known injury. She is 50% recovered. Left knee, calf and thigh pain/strain. Referred to PCP for further work-up prn. Y 10/11/2001 10/14/2001 3 OTH OTH NONE Arthritis to bilateral knees 1
0177859 11/16/2001 KS 1.6 1 .6 M 11/05/2001 Mild hives, started evening 29-OCT. Have continued for one week. OTL Benadryl PRN. U 10/29/2001 10/29/2001 0 MIL MIL NKDA 1
0177860 11/16/2001 NC 38.0 38 F 11/07/2001 Pt developed neck soreness which started on 10/27/01 and has gotten worse with difficulty turning head from side to side noted on 10/30/01. When lying in bed, has difficulty lifting head to turn over. No other symptoms except the usual soreness with TD. On 11/2/01, improvement was noted and had less stiffness and was able to turn head more easily. On 11/7/01, had no problems; better per pt. Y 10/25/2001 10/27/2001 2 PUB PUB Monopril; Lozol; antibiotic NONE Carpal tunnel (both); Osteoporosis; Kidney problems (many years); Blood pressure 1
0177861 11/16/2001 CO 65.0 64 F 11/06/2001 11/06/2001 0.5cc Pneumococcal vaccine Polyvalent 23 given IM left deltoid at 12:10. Received telephone call at 3:55pm. Pt reports arm is red, swollen and warm to touch. Advised to call MD for exam. Pt to provider (of vaccine) office at 4:05 pm. Left arm swollen, red, warm to touch, edematous inflamed from left elbow to shoulder (around injection site). Pt was treated with Zyrtec and sent home. No further complaints reported. Received Influenza vaccine 0.5cc IM to Right arm with no reaction. Y Y 11/06/2001 11/06/2001 0 PUB PVT NONE Pt denies any allergies or previous reactions. 1
0177862 11/16/2001 AK 6.0 6 F 11/09/2001 DTap/IPV #2 (had never been immunized before 08/01). Mom called next AM, temp 104 degree and advised Tylenol/motrin every 4 hours, increased fluids. 11/08/2001 Afebrile but large localized reaction from right shoulder to elbow, red, hot, indurated. Y 11/06/2001 11/07/2001 1 PVT PUB NONE NONE NONE 1
0177863 11/16/2001 CA 23.0 23 F 11/06/2001 Pt immediately developed redness and swelling at the injection site with local welts, 30 seconds later. No other symptoms. Treated with ice X 30 minutes and redness and swelling subsided. Y Y 11/06/2001 11/06/2001 0 NONE OTH PVT NONE NONE NONE 1
0177864 11/16/2001 SD 0.2 0 .2 F 11/01/2001 Increased irriatbility for one week. Y 10/25/2001 10/26/2001 1 NONE PVT PUB NONE NONE 1
0177865 11/16/2001 ID 52.0 53 M 11/08/2001 L upper arm & proximal lower arm - mild to moderate swelling with mild erythema; slight warm to touch, mild pain. Y 11/06/2001 11/07/2001 1 NONE PVT PVT NONE Hx of pneumonia, hyperlipedemia, HTN, esophagitis 1
0177866 11/16/2001 OH 85.0 M 11/07/2001 Pt's arm was swollen and red at the injection site. Y PVT OTH NONE Hyperlipidemia; ASVD 1
0177867 11/16/2001 OH 3.0 3 M 11/05/2001 Pt received DTaP, Comvax and MMR on 10/31/2001, site UNK where received. On 11/02/2001 developed left arm cellulitis approximately 4" oval diameter area of cellulitis/erythema and tender. Y Y 10/31/2001 11/02/2001 2 PUB OTH NONE NONE NONE 1
0177868 11/16/2001 OH 79.0 79 F 11/07/2001 Pt's skin was black and blue at the injection site and was red and swollen at the pneumonia site. Y 11/03/2001 11/04/2001 1 PVT OTH NONE Hypercholesterolemia 1
0177869 11/16/2001 NH 14 M 11/08/2001 Pt has #3 Hepatitis B Vaccination. While walking out to waiting room, he removed Band Aid, saw blood, had syncopal episode. He fell to the floor, hitting his head. BP 100/45 right arm. Legs elevated. Was confused, disoriented to date, time, season. Transported to ER via paramedic ambulance. Time frame <5 minutes from vaccination to syncope. Y Y 11/08/2001 11/08/2001 0 CT scan revealed concussion PVT UNK NONE NONE NONE 1
0177870 11/16/2001 NY 12.0 12 F 11/01/2001 Pt and pt's mother noticed swelling and tenderness to left deltoid area starting on 9/15/01. She was seen in the MD's office on 9/19/01. Y Y 09/14/2001 09/15/2001 1 PVT PVT Allergy to Ceclor, sulfa and bees 1
0177871 11/16/2001 OR 11.0 F 11/09/2001 The pt had seizure about 10 hrs after vaccine and than 2 days after had another. Symptoms included spitting up, shaking, and disorientation, history of seizures with moderate control on carbachol. Had Hep A 4/24/01. Y 10/31/2001 10/31/2001 0 Had carbatrol blood level done 11/2/01 & reported normal. OTH OTH Carbatrol NONE Seizures 1
0177872 11/16/2001 AZ 12.0 12 F 10/30/2001 At 16:00, pt complained of nausea, headache and "feeling sick" and pain on stomach and fever. At 19:00, she started vomiting and continues with pain. The next day at 09:00, she was home from school. She still has symptoms but not as severe. Y 10/29/2001 10/29/2001 0 PUB PUB NONE NONE NONE AZ0124 1
0177873 11/16/2001 MI 16.0 16 M 11/14/2001 Raised, red rash on arms and abdomen. Noticed within 24 hours of administration. Y 11/08/2001 11/09/2001 1 NONE PVT PUB NONE NONE EMI (Educably Mentally Impaired) and no allergies. 1
0177874 11/16/2001 TX 1.08 1 .1 F 11/09/2001 Pt had a fever for 1 day, post vax. She also was on Amoxicillin for Otitis for 1 week. On 11/8/01, she developed a papular (? urticarial) rash. She was seen and treated with Atarax. Recovery is ongoing. N 11/06/2001 11/08/2001 2 OTH PUB PPD/ID/LA/0 previously (given on 10/29/01); Amoxicillin Suspension Otitis Media NONE 1
0177875 11/16/2001 TX 65.0 65 F 11/09/2001 Rash from Pelvis to knees. Y 10/29/2001 11/07/2001 9 PVT PVT 1
0177876 11/16/2001 WI 5.0 5 M 11/09/2001 Left upper area swollen/red. Size 11 by 14 area redness and inuration left upper arm, no pus, onset 24 hours. Treatment: Tylenol, cool compress. Y 11/07/2001 11/08/2001 1 PVT PVT 1
0177877 11/16/2001 NE 27.0 27 F 11/06/2001 Redness around injection site with welts/blisters, hot to touch with tenderness, headaches, cough, malaise, swelling around injection site. Y U 10/22/2001 11/02/2001 11 NONE PUB PVT Orthotricyclin NONE NONE 1
0177878 11/16/2001 HI 70.0 70 F 11/07/2001 Pt developed erythema and edema on shoulder, arm and neck adjacent to injection site. Y Y 10/20/2001 10/20/2001 0 PVT PVT Zocor; Glucophage; Prevacid; Aspirin NONE DM; Nephropathy; PUD; GER; HTN 1
0177879 11/16/2001 VA 5.5 1 .0 M 11/10/2001 Approx. 30-40 lesions/excoriated papules on arms, legs, forehead and hand, post vax. Y U 05/13/1997 11/10/2001 1642 PVT PVT NONE NONE NONE 1
0177880 11/16/2001 CA 17.0 16 F 10/31/2001 Within 2 hours, post vax, pt developed swelling of the face and hives appeared on her body. The pt was attending school. The school nurse notified her mother and told her to give the child Benadryl. The child was given 50mg of Benadryl and the swelling and rash had subsided when seen. No swelling or hives were observed. This pt's male sibling had the same vaccine that day also but had no reaction. Mother is allergic to eggs and strawberries. Y 10/29/2001 10/29/2001 0 PUB PUB Benadryl 50mg po NONE NONE CA010123 1
0177881 11/16/2001 VA 7.0 1 .0 M 11/07/2001 Seen at ER on 10/2/01 for rash. Dx'd varicella per PA. Old records indicate phone call from mother on 9/22/95, that the pt was "fussy with a mild rash". No RX. Y Y 09/18/1995 11/02/2001 2237 PVT PVT 1
0177883 11/16/2001 MO 12.0 12 M 11/01/2001 On 10/28/01 12 noon, pt started with headache "all over", more to L side of head front and back 10/30/01 in AM. 10/31/01 mom noticed rash on back & front of neck and L arm at injection site. Went to ER 10/31/01, 9pm. Dr States he had reaction to immunization. Benadryl and Ibuprofen given in ER. No migraines were diagnoses by Doctor. Y U 10/26/2001 10/28/2001 2 PUB PUB NONE Cough see box 7 1
0177884 11/16/2001 PA 33.0 33 F 11/12/2001 Pt developed a 12cm local erythema that was hard and tender. States rigors, nausea and vomiting and dehydration. Y Y 10/31/2001 11/01/2001 1 WBC-24,000; Urine with redness, proteins, urobilinogen and blood. PVT OTH RAD Allergy to flu vax. 1
0177885 11/16/2001 GA 1 .5 M Given 3/19/2001 - seen in office 3/21/01 R thigh red, swollen, lump local reaction only - walking on leg ok no infection noted. U 03/19/2001 03/20/2001 1 PVT PUB triaminic, tanafed, Albuterol Asthma 1
0177887 11/16/2001 PA 13.0 13 M 11/09/2001 Pt developed localized cellulitis at administration area (left deltoid) of varicella and Hep-B vaccines. Y 11/07/2001 11/07/2001 0 NONE PVT OTH Neuro-devastation since "infancy" 1
0177889 11/16/2001 OH 0.2 0 .2 F 10/29/2001 Pt presented to ER with temp 101.4F, alert. Dx: immunization reaction with fever. No other data available. Y U 10/19/2001 10/19/2001 0 CBC, Blood culture done, No results PUB PUB 1
0177890 11/16/2001 AK 79.0 79 F 11/08/2001 11/06/2001 Red, raised, warm and tender 10 by 15 cm area right deltoid with diaphorens. MD says allergic response. 11/07/2001 Same as above except larger area (deltoid down to elbow, nearly wrapping around arm). 11/08/2001 Essentially resolved, no redness, etc., some yellow discoloration. Y Y 11/05/2001 11/05/2001 0 CBC ordered, results no back OTH PUB Tuberculin Aventis left forearm 10/09/2001 Alzheimer's Dementia History of Squamous cell carcinoma right hand, scoliosis and obesity. 1
0177891 11/16/2001 AZ 1.0 1 .7 F 11/05/2001 Had chicken pox after Varivax given. 09/24/2001 11/05/2001 42 PVT PUB 1
0177892 11/19/2001 MS 0.24 0 .2 M 11/08/2001 Around 5 AM on 11/4/01, pt woke up crying so father got up and fed him formula and cereal. Father laid in recliner with baby on chest. About an hour later when mother got up and went to where they were, she found the baby dead. Father upset "that he might have smothered the baby." Y 11/04/2001 N 11/02/2001 11/04/2001 2 Autopsy results pending PUB PUB NONE NONE Born at 34 wks gestation MS01050 1
0177893 11/19/2001 NJ 6.0 F 11/15/2001 Pt recvd an unspecified number of doses of Orimune from 1992 until 6/13/97. In November, 1998, pt was diagnosed with "medulloblastoma, a tumor of the brain." Following various attempts at treatment, the pt died on 10/7/99. The pt's parents requested testing of the tumor to determine the presence or absence of SV40. As of the date of this report, testing was ongoing. As of the date of this report, no further info was available. Reported on 02/27/2003: "Follow-up information (medical records) received 02/13/2003 provided dates of vaccination, CT-scan, and MRI results. Information was received 11/12/2001 from an attorney regarding a 6-year-old female who received three doses of Orimune from 12/1992 until 06/1997. On 11/16/16988, the patient was hospitalized due to changes in mental status. Prior to hospitalization the patient had a three week history of vomiting, headache, and malaise. A CT-scan revealed a posterior fossa tumor and normal ventricular size. The patient underwent surgery to remove the tumor and pathology revealed medulloblastoma. On 12/01/1998, a magnetic resonance imaging scan (MRI) of the spine revealed no evidence of metaphysis. In 03/1999, the patient was admitted for chemotherapy (vincristine and cisplatin), while hospitalized the patient underwent an esophagogastroduodenoscopy which revealed mild to moderate esophagitis. A CT-scan of the abdomen was performed to rule out "mass lesions" and this was found to be within normal limits. On 08/26/199, the paitent was brought to the emergency room after experiencing nausea, vomiting, headache, and altered mental status with decreased level of conscioiusness. A MRI of the head showed increased ventricular size, and a craniotomy was performed for revision of her shunt. Shunt culture and cerebral spinal fluid cultures were negative, but biopsy revealed malignant spread of the medulloblastoma to the leptomeninges. On 07/27/1999 the patient developed seizures and went into status epilepticus. Treatment included Ativan and Fosphenytoin, and the patient was subsequently incubated for respiratory failure. Physician notes stated that the new onset of seizures were likely secondary to the metastasis. Legal complaint stated that following various attempts at treatment, the patient died on 10/07/1999. The patient's parents reequested testing of the tumor to determine the presence or absence of SV40; as of the date of this report, testing was ongoing. Follow up on 02/09/04: "Medical records received provided revised dates of vaccination. Information was received from an attorney regarding a 6 year old female who received four doses of Orimune from December 1992 until June 1997. On 11/16/1988, the pt was hospitalized due to changes in mental status. Prior to hospitalization the pt had a three week history of vomiting, headache, and malaise. A CT-scan revealed a posterior fosma tumor and normal ventricular size. The pt underwent surgery to remove the tumor and pathology revealed medulloblastoma. On 12/01/98, a magnetic resonance imaging scan (MRI) of the spine revealed no evidence of metaphysis. In March 1999, the pt was admitted for chemotherapy (vincristine and cisplatin); while hospitalized the pt underwent an esophagogastroduodenoscopy which revealed mild to moderate esophagitis. A CT-scan of the abdomen was performed to rule out "mass lesions" and this was found to be within normal limits. On 08/26/99, the pt was brought to the ER after experiencing nausea, vomiting, headache, and altered mental status with decreased level of consciousness. A MRI of the head showed increased ventricular size, and a craniotomy was performed for revision of her shunt. Shunt culture and cerebral spinal fluid cultures were negative, but biopsy revealed malignant spread of the medulloblastoma to the leptomeninges. On 08/27/99 the pt developed seizures and went into status epilepticus. Treatment included Ativan and Fosphenytoin, and the pt was subsequently intubated for respiratory failure. Physician notes stated that the new onset of seizures were likely secondary to the metastasis. Legan complaint stated that following various attempts at treatment, the pt died on 10/07/99. The pt's parents requested testing of the tumor to determine the presence or absence of SV40; as of the date of this report, testing was ongoing. Medical records are on file. Y 10/07/1999 Y N 01/01/1992 11/01/1998 2496 Biopsy NOS (LLT:biopsy) 08/27/1999; Meninges biopsy was positive for metastatic medulloblastoma Computerised tomogram (LLT: CT scan) 11/16/1996; CT-scan revealed a posterior foses tumor and normal ventricular size. 03/08/1999; CT scan of the abdomen was within normal limits Culture NOS (LLT: Culture NOS) 08/26/1999; Shunt culture and cerebral spinal fluid culture were negative Nuclear Magnetic Resonance Imaging (LLT: MRI) 12/01/1998; MRI of the spine revealed no evidence of metaphysis 08/00/1999; MRI of the head showed increased ventricular size Oesophagogastroduodenoscopy (LLT: Oesophagogastroduodenoscopy) 03/00/1999; revealed mild to moderate esphagitis. OTH OTH UNK UNK UNK HQ8460414NOV2001 1
0177895 11/19/2001 AL 69.0 68 M 11/15/2001 A consumer reported that her 69 year old father received Flu Shield vaccine ('00-'01) in 11/00. According to the daughter, in 12/00, her father "couldn't get (his) heart in rhythm and it was racing". His health care provider cardioverted the pt X 2 and he also had a cardiac ablation procedure. He was hospitalized. No additional information was available as of the date of this report. Y Y U 11/01/2000 12/01/2000 30 UNK OTH PVT Amaryl; amiodarone hydrochloride; Coumadin; Prandin "Kuhn"; Vasotec UNK Cardiac failure congestive; Lung disorder NOS HQ8336412NOV2001 1
0177899 11/19/2001 FL 42.0 42 F 12/14/2001 Information has been received from a RN concerning a 42 year old female with pulmonary disease, asthma, arthralgia, hypertension, and sulfa allergy and a history of pneumonia, obesity and benign left breast disease who on 10/29/01 was vaccinated. The RN stated that within 24 hours of receiving the vaccine the pt experienced a temperature of 101 to 102.6 F, along with localized injection site reaction of the left deltoid. On 10/31/01 the pt presented to the Dr's office with worsening arthralgia, an elevated WBC of 20,000, vomiting, diarrhea, headache, parathesia and a rash on the left arm and face. A chest x-ray was negative. Subsequently, on 10/31/01, the pt was hospitalized. This is in follow-up to report(s) previously submitted on 11/9/01. Information has been received from a registered nurse concenring a 42 year old obese (231 lbs.) white female with asthma, hypertension, sulfa allergy, hiatal hernia, gastroesophageal reflux disease, hypothyroidism, rhinitis, arthralgia, breast disorder (left breast disease benigh) and lab test abnormality (abnormal mamogram) and a history of pneumonia, total abdominal hysterectomy and bilateral salpingo-cophorectomy for endometriosis, tonsillectomy, partial colectomy, abdominal abscess drainage, joint stiffness, hemoptysis, hypercholesterolemia and intestinal diverticulitis who on 10/29/01 was vaccinated in the left deltoid with pneumococcal vaccine 23 polyvalent (lot 636849/0944K). Concomitant therapy included montelukast sodium, rofecoxib, Claritin, Synthroid, Micardis, Prevacid, estrogene, Premarin, Advair, Ortho-cyclen and Flonase. On 10/30/01, the pt's arm started to hurt, swell and get red. By 4-4:30pm the pt developed a fever. She became nauseated by 8pm, vomited and had diarrhea at approximately 2am. All night she had a fever of 101 to 102.6 F. She had no chest pain, cough or increased shortness of breath. On 10/31/01, the pt presented to the physician's office with worsening of arthralgia, an elevated white blood cell count, vomiting, diarrhea, headache, paresthesia and a rash on the left arm and face. On physical exam her temperature was 102 F. Her left arm was swollen and tender. There was a patch of erythema laterally in the upper arm. The pt complained of worsening arthralgia and joint stiffness since the left arm swelling began, but here was no obvious joint swelling. Her white blood cell count was 20,600 with 87 segs. A chest x-ray showed no acute infiltrate. Subsequently, on 10/31/01, the pt was admitted to the hospital and started on IV fluide, IV Unasyn and placed on clear liquid diet. Her physical exam upon hospitalization revealed a temperature of 101, pulse of 92 and respirations of 12. Chest was clear to auscultation. Cardiovascular revealed a regular rate of rhythm, no S3 gallop, murmur or rub, a positive S4 was heard. Abdomen was soft, non-tender and non-distended. Pelvis was stable. Spine showed no areas of tenderness. Lower extremities showed no deformatities and were moving well. Examination of the left arm showed an area of approximately 6cm in diameter in the upper third of the upper arm, located primarily posteriorly of erythema and slight induration with tenderness to palpation. There was a little bit of tenderness proximal to that area in the region of the shoulder and for approximately 2cm dista. The area around the elbow, forearm, wrist and hand were non-tender. The pt was able to move her fingers well and light touch sensation was intact in the median, ulnar and radial nerve distribution. She had 2+ radial pulse. There was no tenderness on the anterior aspect of the arm. Compartments appeared to be soft and there was no crepitation noted. There was no necrotic skin noted. Shoulder range of motion caused discomfort in the area of the redness and was somewhat limited secondary to the pain although on passive range of motion with the arm at her sides, no significant discomfort. There was no gross fluctuance present. There was no adenopathy in the fractures Y Y 10/29/2001 10/29/2001 0 CXR-neg; WBC-20,000; magnetic resonance-revealed an area centered mostly over the distal deltoid by cellulitis of the skin; upper extremity x-ray-demonstrated no fractures, dislocations or evidence of osteomylitis; hemoglobin 13.8; segmented neutrophil 87; vital sign-temp 102.3, BP 130/88, O2 rate 98% UNK UNK Albuterol, Premarin, Ortho-Cyclen, Advair, Prevacid, Synthroid, Claritin, Singulair, Micardis, Vioxx, arthralgia, sulfa allergy, respiratory condition, hypertension, asthma, Breast disorder, obesity, pneumonia, abcess drainage, hemoptysis, hysterectomy, intestinal diverticulitis, tonsillectomy, salpingo-oophorectomy, partial colectomy, hypercholesterolemia, endometriosis, joint stiffness, arthralgia, sulfa allergy, rhinitis, hypothyroidism, asthma, hiatal hernia, hypertension, gastroesophageal reflux disease WAES01110025 1
0177902 11/19/2001 NY 57.0 M 11/09/2001 Information has been received from a pharmacist concerning a 57 year old male who in 1992 was vaccinated with a 1st dose and on 10/25/01 was vaccinated with a 2nd dose of pneumococcal vaccine 23 polyvalent. On 10/27/01, the pt was admitted to the hospital with cellulitis. On 10/30/01, the pt was still hospitalized and was receiving treatment with vancomycin. The nurse reported that she was not certain of the pt's status as of 11/2/01. Additional information has been requested. Y Y N 10/25/2001 10/27/2001 2 OTH OTH UNK WAES01106359 1
0177907 11/19/2001 AZ 57.0 57 F 11/13/2001 Pt had no history of varicella and varicella titer was negative. Fifteen days post vax pt started running a fever. 10/29/01 pt noted the appearance of red spots that over 10 days erupted and evolved like varicella only with a longer time period than expected. On 10/31/01 pt was given Atarax for itching and rash. Pt continued with a low grade fever of 100.3-100.5 daily. On 11/7/01, a nurse made a home visit which was followed by blood tests and a chest x-ray on 11/8/01, and pt was started on Acyclovir. On 11/10/01, pt had more blood tests and a urinalysis. She was started on Cipro for a possible UTI. On 11/13/01, pt's fever increased to 102F, and she was admitted to the hospital for evaluation. Y Y 10/27/2001 10/27/2001 0 11/8/01 CBC: wnl except for WBC of 17.5, Hgb 12.7, Hct 39.9, MCH 26.3, platelets 473, neutrophils 13.3; chest x-ray: no acute disease 11/10/01 Repeat CBC: virtually same result; ESR 85, UA blood trace, leukocyte neg; RBC 3-4, WBC 1-3, bacteria mod, epicells many OTH OTH Hypertension, asthma 1
0177908 11/19/2001 53.0 M 11/13/2001 Pt was admitted to hospital with symptoms of congestive heart failure. Pt was normally in excellent health. Cardiologist's diagnosis was active viral myocarditis. Y U 10/19/2001 11/13/2001 25 ECHO: left ventricle markedly dilated with severe diffuse hypokinesia and an ejection fraction of less than 20%; blood cultures: neg; BUN/SCr: 19/2.0; left heart cath: left ventricular dysfunction with dilated cardiomyopathy OTH OTH Kidney stones, penicillin allergy, hypertension 1
0177909 11/19/2001 NY 18.0 18 M 09/30/2001 Generalized Weakness, lodd ofL.E.function, Hospitalized 08/26/01, dx with GBS Y Y Y 06/22/2001 08/24/2001 63 PUB OTH Vit C 500 mg qd NONE Asthma 1
0177910 11/19/2001 VA 10.0 10 M 11/09/2001 Pt developed headache, nausea, irritability, stiff neck, vomiting, sleepiness all the time, and loss of peripheral vision. Doctor's won't conclude 100% that it was due to Hepatitis B vax. FU states pt has severe optic neuropathy OD and mild optic neuropathy OS, both secondary to parainfectious meningitis with increased intracranial pressure. Per doc 213384, 60 day follow-up, no further information is available. Per annual follow up: pt has not recovered. He has some permanent visual (optic atrophy) impairment. Y 11 Y U 09/28/2001 10/04/2001 6 Blood tests, 3 spinal taps, CT scan, MRI, EEG. FU states serology indicates mycoplasma pneumonia infection OTH OTH 1
0177911 11/19/2001 AR 9.0 4 M 10/15/2001 Pt was diagnosed with autistic disorder at the age of 5. Parents and pt's doctor believe it is due to mercury in the immunizations he received. Lab and hair tests show pt is toxic with high levels of several heavy metals. Pt is currently being detoxed. Y N 05/06/1997 Blood, urine and hair samples: high levels of several heavy metals PUB PVT NONE NONE 1
0177912 11/19/2001 IA 72.0 72 M 11/08/2001 Pain, erytheme at injection site in right deltoid. One week later had fever, malaise and extremely weak. Y 10/30/2001 11/06/2001 7 WBC 4.2 CXR-N1 PVT PVT NONE NONE Horse serum 1
0177913 11/19/2001 NE 50.0 50 F 11/06/2001 Sore, tender, painful left shoulder down to elbow. U 10/25/2001 10/25/2001 0 NONE PVT PVT Premerin 0.625mg NONE NONE 1
0177914 11/19/2001 NJ 26.0 26 F 10/26/2001 Administered 0.5 mg Flu vaccine left deltoid at 10:20AM. AT 10:35AM pt alerted staff of flushing, "swallowing strange" and "tongue curling". At 10:40AM Benadryl 25mg given. At 12:30PM pt reports resolution of symptoms, swallowing and tongue sensation. SL. residual groggy 2 hours Benadryl. Y 10/25/2001 10/25/2001 0 OTH OTH NONE NONE NONE 1
0177915 11/19/2001 NJ 30.0 30 F 10/26/2001 Employee Received Flu vaccine 10/23/2001 At 2pm, 0.5 mL IM left deltoid. Reported on 10/25/2001 that half hour after injection experienced upper lip and nose area tingling, slight numbness. Persisted for one hour. No treatment resolved. Y 10/23/2001 10/23/2001 0 OTH OTH NONE NONE NONE 1
0177916 11/19/2001 IL 52.0 52 F 11/16/2001 The day after the Flu shot, I experienced dizzy spells. These lasted 1.5 days. Y 11/14/2001 11/15/2001 1 OTH OTH NONE Allergic rhinitis, asthma and hypothyroidism. 1
0177917 11/19/2001 KY 39.0 39 F 11/16/2001 A knot the size of baseball, red, hot where the knot is. Y U 11/14/2001 11/15/2001 1 OTH OTH NONE NONE 1
0177918 11/19/2001 NY 50.0 50 F 11/07/2001 Within minutes of Flu vaccine c/o itching. Referred to internal medicine given Benadryl 15mg PO, within 10 minutes c/o throat closing, difficult to breath, given Epi 0.3 ml, no relief. Was referred to ER. Y 11/01/2001 11/01/2001 0 PVT UNK Albuterol, Flovent, Prilosec, and Seravent. NONE E-mycin, Propulsid and local reaction to Flu vaccines. 1
0177919 11/19/2001 LA 0.7 0 .6 F 11/11/2001 After 2nd set of shots, some spastic movement noted, but most noticeable was after her 3rd set (June 2000), her speech, (babbling & saying da-da) had stopped and has not said anything since. Y N 06/12/2000 06/17/2000 5 October 2001 tested positive for heavy metal toxicity PVT OTH Ear and sinus infections 1
0177920 11/19/2001 NC 2.8 2 .9 F 11/01/2001 Swelling of leg at injection site. Fever up to 102. U 10/31/2001 10/31/2001 0 OTH PVT NONE Sickle Cell Anemia 1
0177921 11/19/2001 WY 77 M 11/16/2001 Left upper arm red, swollen ant warm to touch from deltoid to elbow. Temperature 97.5 then elevated to 100.5 for night shift, down with Tylenol 650mg PO. On 11/16/2001 still red with decrease of swelling, afebrile. U 11/13/2001 11/14/2001 1 NONE OTH PVT NONE (Diamox-allergies) Alzheimer's, CAD, Osteoarthritis, peripheral edema, depression disorder non-psychotic. 1
0177922 11/19/2001 NJ 67.0 67 F 11/12/2001 Received flu shot at 9:20AM and 11:45AM broke out in the hives on 10/24/2001. Hives lasted about 2.5 hours. Y Y 10/24/2001 10/24/2001 0 PUB OTH Niacin 1 week no previous reaction NONE Penicillin 1
0177923 11/19/2001 KY 44.0 44 F 11/11/2001 Large red spot. Warm to touch. Y 11/08/2001 11/08/2001 0 NONE PUB UNK NONE NONE Allergic to dust, cats, trees and pollen. 1
0177924 11/19/2001 TX 35.0 35 M 11/13/2001 Vaccination done on 10/26/2001. Malaise and body aches started on 10/29/2001 afternoon. Fever on 10/29/2001 night. Responded to Motrin. Muscle aches slowly improving, but currently have scratchy throat. No fever in past 4-5 days. 10/26/2001 10/29/2001 3 PUB PUB NONE NONE Allergy to bee stings; Hepatitis A. 1
0177925 11/19/2001 NY 35.0 34 F 11/09/2001 Hives begining evening of 11/02/2001, lasting thru 11/04/2001. Took Benadryl syrup to relieve itching. Total body, except head. Y 11/02/2001 11/02/2001 0 NONE OTH PVT NONE NONE Hay Fever type allergies 1
0177926 11/19/2001 IN 55.0 55 F 11/13/2001 Raised, red welt half way around arm. Very hot and sensitive in same area also in underarm. Y 10/31/2001 11/01/2001 1 OTH PVT Synthroid, Premarin and Provera NONE Hypothyroidism 1
0177927 11/19/2001 AL 47.0 46 F 11/08/2001 Developed Swelling around injection site extending to an area of approximately 2.5 inches in circumference, pain at site, extending to left side of neck, left upper extremity "tightness" reported. Treatment: took OTC Benadryl. Y 11/07/2001 11/07/2001 0 OTH PVT Premarin NONE NONE local reaction~Influenza (Seasonal) (no brand name)~~0.00~In Patient 1
0177928 11/19/2001 NY 65.0 65 F 11/13/2001 Swollen, red and painful to touch area (upper arm). Hives on my upper right arm. This lasted for 2-3 days. Y 10/23/2001 10/23/2001 0 OTH OTH Lopressor, Premarin, Progesterone, Hyzaar, Multi Vitamin and Calcium. NONE 1
0177929 11/19/2001 VA 40.0 40 F 11/17/2001 Approximately 20 minutes after receiving the influenza injection on 11/06/2001, client reported that her hands, especially the palms, and her feet were itchy and that her hands seemed to be somewhat swollen, requiring her to remove her rings. RN informed her supervisor and telephoned the HD MD, who advised that this was a "normal variation" and that client should take 25mg of Benadryl when she gets home. About an hour later, around 4:05 PM, client reported to another nurse in Clinic that her bottom lip was itchy, slightly swollen and her tongue was tingling. This nurse consulted with the supervisor, who instructed her to promptly call MD for further guidance. MD advised client to take two 25 mg Benadryl immediately and go home, which client did. By the time the client arrived home, she was experiencing some difficulty swallowing along with some soreness in her throat and was beginning to have some difficulty breathing. Her husband accompanied her to the ER, where she received epinephrine with IV fluids, an injection of Benadryl and an oral dose of Prednisone. She was observed for an hour, her symptoms improved and she was discharged with a Prescription of Zantac and Claritin, as well as continued Prednisone. Client also reports that she has had some local redness, swelling and discomfort in the left deltoid area around the injection site. Y Y 11/06/2001 11/06/2001 0 PUB PUB Zantac, Atenol, Elmiron, Triametrine/HCTZ and Aspirin. NONE Allergic to preservative (DMSO) used in bladder wash; Asthma; Seasonal Allergies. VA01031 1
0177930 11/19/2001 MD 45.0 45 F 11/01/2001 Large 12cm diameter local reaction left upper extremity. Y Y 10/30/2001 10/30/2001 0 PVT PUB NONE PCN, Thorazine, Sulfa 1
0177931 11/19/2001 NC 2.0 2 .0 F 11/02/2001 Right thigh red, warm to touch. Three inches diameter area. Atarax Rx Y U 07/15/2001 NONE PVT PUB NONE NONE Allergic to Amoxicillin. 1
0177932 11/19/2001 MO 0 .2 F 11/12/2001 Parents described high pitch cry for approximately 12 hours would fall asleep exhausted for a while and woke up screaming. Difficult to console. Also refused to eat and unable to sleep that night of receiving the vaccines, would wake up screaming off and on. Pt had low grade fever temp 100 for about 12 hours also. Y 09/04/2001 09/04/2001 0 NONE PVT PVT NONE NONE NONE 1
0177933 11/19/2001 CT 78.0 75 F 11/12/2001 Pt developed extreme fatigue for the past 2 years which is treated with prednisone and Imuran for auto immune hepatitis. Y N 05/01/1999 09/01/1999 123 Blood tests and liver biopsy PVT PVT 1
0177934 11/19/2001 FL 47.0 47 F 10/30/2001 Swelling and increased temperature over the left arm deltoid area. Y 10/26/2001 10/26/2001 0 PVT PVT Laceration right second finger Allergy to Iodine; Diabetes 1
0177935 11/19/2001 NC 5.0 5 M 11/06/2001 Pt had DPT and Polio vaccine given in left arm, MMR given in right arm, given on July 25, 2001. Reaction occur 07/27/2001, red area, swollen and hot to touch. Y 07/25/2001 07/28/2001 3 PVT OTH NKDA NC01098 1
0177937 11/19/2001 CT 4.0 4 M 11/12/2001 Red, tender, hard local reaction 3.5 inches in size. Y Y 11/08/2001 11/09/2001 1 PVT PUB NONE NONE 1
0177938 11/19/2001 PA 7.0 3 M 11/09/2001 No description provided Y 09/10/1998 11/07/2001 1154 NONE PVT PVT NONE NONE NONE 1
0177939 11/19/2001 GA 7.0 7 M 11/12/2001 Cellulitis and viral exanthema. Y 10/31/2001 11/08/2001 8 NONE PVT PVT Surgery 2 hour shark bite 1
0177940 11/19/2001 NJ 5.0 0 1 M 11/13/2001 Chicken pox lesions onset 11/13/2001, afebrile, itchy, symptomatic treatment. Y U 12/12/1996 11/13/2001 1797 PVT PVT NONE NONE NONE 1
0177941 11/19/2001 NJ 3.0 1 .0 M 11/13/2001 Mother noticed rash 10/31/2001, 3 spots on face and trunk and diaper area. 11/01/2001 one spot on ear and arm associated with cough for 2 days and HA at presentation. Y Y 08/02/1999 11/01/2001 822 NONE PVT PVT Xopenex 0.63 nebsolntid NONE Asthma;Peanuts and eggs. 1
0177942 11/19/2001 CA 4.0 4 F 11/18/2001 Left arm very edematous warm to touch. Y 11/07/2001 11/07/2001 0 PVT UNK NONE NONE NONE 1
0177943 11/19/2001 CA 4.0 4 F 11/12/2001 The patient experienced swelling, redness and induration at the injection site 3 days post vax. N 11/09/2001 11/10/2001 1 NONE OTH PUB NONE NONE 1
0177944 11/19/2001 WV 47.0 47 F The patient developed a large area of erythema with urticaria on the left arm from the elbow, past the shoulder with swelling. Y 11/08/2001 11/09/2001 1 NONE UNK UNK Allergic Rhinitis Allergies and COPD. 1
0177945 11/19/2001 NE 37.0 37 F 11/14/2001 The patient developed a rash, swelling, and redness at the injection site. The patient was flushed, nauseated, had hand, arm and shoulder pain. The patient's tongue was numb and tingling. Y Y 11/13/2001 11/13/2001 0 NONE OTH PVT Lorcef NONE Allergic to codeine. 1
0177946 11/19/2001 CA 59.0 59 F 11/12/2001 11/12/2001 the patient experienced local erythema of the left arm in an area 12cm x 15cm. The patient was treated with Benadryl for itching, TAC cream and cool compresses. Y 11/09/2001 11/10/2001 1 OTH PVT HCTZ Cellulitis of the right hand. Hypertension. 1
0177947 11/19/2001 AZ 35.0 35 F 10/31/2001 Reaction after her CT. #3 Hep B vaccine given 10/29/01. Check out hot flashes, hives, dizziness and red bruised. CT area at injection site. Symptoms occurred that same evening. U 10/29/2001 10/29/2001 0 PUB PVT 1
0177948 11/19/2001 FL 0.3 0 .4 M 11/16/2001 Approximately 5-10 minutes after receiving vaccine suddenly stopped crying, "passed out" according to eye-witness, and turned blue in color. The pt was immediately returned to provider's office where he continued to "sleep" until removed from car seat and taken, "taken exam room. He awoke gradually and pleasantly. Immediate a subsequent PE's were normal. Immediate PO2 sats were 96. Patient was observed for another 2 hours and vital signs weere monitored for approximately every 15 minutes to half hour. All vitals remained within normal levels and PO2 sats gradually elevated to 98 over the course of observation. Y Y 11/15/2001 11/15/2001 0 PVT PVT 1
0177949 11/19/2001 FL 0.2 0 .2 M 11/16/2001 Cried forcefully immediately after receiving vaccines for approx. 5 minutes then suddenly stopped crying and fell asleep. The pt simultaneously broke out into an urticarial rash of the head, face and torso. The immediate Temp was 99.1 rectal. Immediate PE and subsequent PE's were normal. Pt was observed for approx. 2 hours in the office while he feed and rested easily. Y Y 11/15/2001 11/15/2001 0 PVT PVT mild URI (nasal congestion) 1
0177950 11/19/2001 KY 59.0 59 F 11/09/2001 Mid-afternoon, the day of the vaccination, the patient experienced swelling and tenderness of the glands under each ear and down the side of the throat towards the thyroid. The patient did not have a fever but by mid-afternoon the next day the patient had chills for about 3 hours. Y 10/16/2001 10/16/2001 0 OTH UNK Metoprolol, Dilantin, Zestril, Prazosin, Lasix, Clonidine, Norvasc and Folic Acid. Polycystic disease of the kidneys and liver, enlarged thyroid, also some seizure activity. Implanted pacemaker in 2000. Flu like symptoms~Influenza (Seasonal) (no brand name)~1~19.00~In Patient 1
0177951 11/19/2001 MT 40.0 39 M 05/30/2001 Post vax the patient experienced redness and soreness at the injection site. Approximately 1 month later the patient was noticing stiffness in his joints. Y 03/02/2001 04/10/2001 39 MIL MIL 1
0177952 11/19/2001 NJ 67.0 67 F 11/07/2001 The patient developed a rash on her face, ears, backside and arm. The patient was treated with Prednisone. On 11/12 the rash is better. Y N 10/26/2001 10/27/2001 1 PUB PVT 1
0177955 11/20/2001 NY 44.0 M 11/16/2001 It was reported that a 44 year old white male was vaccinated in 1995 with a dose of pneumococcal vaccine 23 polyvalent and a dose of influenza virus vaccine. At the time of vaccination, the pt's CD4 count was 250 cells/microL (19%) and he was prescribed concomitantly zidovudine, lamivudine and sulfamethoxazole/trimethoprim. It was noted that over the subsequent 2 years, there was a transient increase of his CD4 count to a maximum of 370 cells/microL and then a slow decline. The pt presented in 4/97 to the ER with a 6 day history of violent shaking chills, night sweat and malaise. The pt reported shortness of breath, occasional blood-tinged sputum and pleuritic chest pain for 3 days. The pt was known to have been HIV (+) for 8 years, with risk factors including IV drug abuse. It was noted that the pt had received medical care at the infectious disease clinic at the same hospital. It was noted that at his last appointment, 3 months prior to his presentation to the ER, the pt had a CD4 cell count of 216 cells/microL (16%) and his viral load was 1270 copies/mL. It was reported that the pt completely recovered from a hepatitis b infection, but hat a history of chronic sinusitis and hepatitis C. The pt had never suffered from the opportunistic infections common in AIDS. It was reported that in the ER, the pt was poorly cooperative, appeared pale and coughed occasionally. He was afebrile, hypoxemic and had oliguria. Septic shock with severe bacterial pneumonia was dx'd. Ceftazidime, erythromycin, sulfamethoxazole/trimethoprim and IV hydration were administered. It was reported that the pt required orotracheal intubation and mechanical ventilation. About 11 hours after presenting to the ER, the pt developed recurrent ventricular tachycardia and expired. It was noted that with the exception of minimal aseptic leptomeningitis, the neuropathological findings were unremarkable. There was no evidence that the pt had a concurrent influenza infection. It was reported that Streptococcus pneumoniae was cultured from various blood samples. The organism was sensitive to penicillin, chloramphenicol, vancomycin and erythromycin. It was noted that the pneumococcal vaccine 23 polyvalent included isotype 3. Y Y Y N 01/01/1995 04/01/1997 821 RR-40/min; BP-91/60 mmHg; HR-114/min; breath sounds over his right lung field were decreased; CXR-showed an infiltrate of the entire right lung; Autopsy-showed lobar pneumonia, pleural effusion, ascites, cardiomegaly with unremarkable valves, esophageal varices, splenomegaly and hepatomegaly with liver cirrhosis. Histopathology of the lungs revealed sheets of acute and chronic inflammatory cells diffusely filling the alveolar spaces, intra-alveolar edema and capillary congestion. Histopathology of the liver revealed cirrhotic micronodules surrounded by bridging bands of fibrosis with portal ductular proliferation and moderately periductual lymphocytic infiltrate. Histopathology of the spleen showed marked sinusoidal congestion with mild depletion of the white pulp. Lymph nodes showed mild follicular depletion. Isotyping confirmed S. pneumonia, strain type 3. OTH OTH lamivudine; sulfamethoxazole (+) zidovudine Cirrhosis; human immunodeficiency virus antigen positive; hepatitis C; drug abuse Chronic sinusitis; hepatitis B WAES01110449 1
0177956 11/20/2001 MA 31.0 31 F 11/15/2001 Pt believes she became pregnant on 1/19/01 after receiving varicella virus vaccine on 12/14/00. Pt's last menstrual period was on 1/5/01. The pt planned to see her health care provider on 2/2/01. The OB/GYN reported the pt had no previous pregnancies. No fetal heart beat was detected on two ultrasounds. The pt had a spontaneous abortion on 3/13/01, 9 5/7 weeks from her last menstrual period. The products of conception were examined. It was not known if the fetus was normal. No further info is available. Y U 12/14/2000 03/13/2001 89 Ultrasound to rule out a missed abortion and no fetal heart beat was detected OTH OTH Prenatal vitamins WAES01020266 1
0177957 11/20/2001 AZ M 11/16/2001 On 11/7/01, one day post vax, pt experienced a bad reaction which included severe swelling and redness at injection site. The pt was seen in the ER and was admitted due to additional concerns with his pre-existing cardiac condition. The reporter indicated a concern with the lot number. It was reported that the pt's wife (WAES 01111505) had a similar experience following exposure to pneumococcal vaccine 23 polyvalent. Addtl info has been requested. Y Y U 11/06/2001 11/07/2001 1 OTH OTH UNK Concurrent conditions: cardiac disorder WAES01111065 1
0177961 11/20/2001 NV 5.0 F 11/14/2001 Information has been received regarding a case in litigation concerning a 5 year old female who prior to vaccination was described as being "a well and healthy, normally developing, happy young girl" who on 8/10/00 was vaccinated with MMRII. It was reported that the pt subsequently developed a high fever, severe salmon colored rash and extreme pain in her lower extremity joints. She was admitted to the hospital on 9/29/00 and discharged from the hospital on 10/6/00. She was dx'd with systemic juvenile rheumatoid arthritis or "Still's disease". The pt had "profound" pain in her lower extremities and joints, difficulty walking, poor appetite, nausea, weight loss, arthritis, fever, hair loss and severe rashes over her entire body, rendering her permanently and totally disabled. It was expected that she would continue to suffer mental and physical impairments and pain in the future. Systemic juvenile rheumatoid arthritis was reported to be disabling. No further information is available. Y Y 8 Y N 08/10/2000 09/29/2000 50 OTH OTH UNK UNK WAES01110684 1
0177966 11/20/2001 UT F 11/15/2001 Information has been received from an aunt of a female consumer who on an unspecified date was vaccinated with hepatitis A virus vaccine inactivated. Subsequently, the pt vomited for 2 days straight and experienced a fever of 102F. The child was treated with promethazine hydrochloride (Phenergan) which stopped the vomiting. On 11/2/01, the pt experienced a seizure. The child was hospitalized for the events. It was reported that the child had "several more" seizures while in the hospital. The events were considered to be immediately life-threatening. At the time of this report, the outcome of the fever and seizure was unknown. Additional information has been requested. Y Y Y U 11/02/2001 Temperature measurement-102F OTH OTH NONE NONE WAES01110340 1
0177967 11/20/2001 CA 13.0 13 F 11/16/2001 Information has been received from a consumer concerning his 13 year old daughter who on 9/17/01 at 14:30 (also reported as 15:30) was vaccinated with a 1st dose (lot 639764/0587L) IM in the left arm of hepatitis A virus vaccine inactivated. On 9/17/01, at 22:30, the pt was taken to the hospital with a fever of 101F and stomach cramps (it was also reported that the abdominal pain began in the morning of 9/18/01). Follow-up information received from a physician indicated that the pt underwent an appendectomy on 9/18/01 and symptoms resolved. It was noted that the pt's abdominal pain was secondary to the appendicitis. A pathological exam on 9/19/01 dx'd the pt with an "acute appendicitis with early fibrinopurulent periappendicitis" that was "negative for malignancy". The pt was hospitalized for 6 days. The physician felt that the abdominal pain and the appendicitis were not related to the therapy with hepatitis A virus vaccine inactivated. No further info is available. Y Y 6 Y 09/17/2001 09/17/2001 0 Pathological exam-acute appendicitis; Temperature measurement-101F PVT OTH NONE NONE WAES01092009 1
0177968 11/20/2001 WI 6.0 0 .0 M 11/07/2001 Autism which showed the 1st signs at 2 years of age. Showed some possible signs earlier. Mother received MMR on 10/24/1995 while nursing. Per 1 year follow up: Pt did not recover. Pt has an "Autism" diagnosis which I believe was caused by his frequent and large number of vaccines- containing Thimerasol before 6 months of age. Y N 10/23/1995 PUB OTH NONE NONE NONE 1
0177969 11/20/2001 AR 0.4 0 .4 F 11/12/2001 Approximately 4 hours post vax, pt became cool, clammy, and unresponsive. She was taken to ER where she was observed to have a generalized tonic-clonic seizure lasting 1 minute. She required endotracheal tube with bag ventilation and IV fluids. Y Y Y 2 Y 11/09/2001 11/09/2001 0 CBC-wnl; UA-clear; CSF-neg; blood C&S-neg; metabolites-neg PUB OTH NONE NONE NONE 1
0177971 11/20/2001 KY 4.0 4 M 11/16/2001 Pt developed Henoch-Schonlein purpura vs ITP. Y 4 Y 01/10/1997 01/13/1997 3 PVT PUB 1
0177972 11/20/2001 CA 16.0 16 F 11/16/2001 Pt developed polymyositis with weakness which began 11/7/01. Follow up letter from reporter dated 11/16/2001 states that "After further investigating the PCP discover that this pt was not experiencing adverse event onset due to Hep A. VAERS was notified immediately." Y 4 U 10/29/2001 11/07/2001 9 CPK 677 OTH OTH Aventis PPD (Mantoux) subcutaneous right forearm NONE 1
0177973 11/20/2001 PA 6.0 6 F 11/12/2001 Within 5 minutes of receiving vax, pt had a staring spell followed by tonic-clonic seizure. Doc 208117 states the following: patient with history of developmental delay and seizures. Y Y 1 Y 11/09/2001 11/09/2001 0 Anticonvulsant levels both therapeutic. PVT PUB Depakote, Tegretol NONE Cerebral palsy, developmental delay, seizure disorder, allergy to penicillin, hydrocephalus with 2 VP shunts 1
0177974 11/20/2001 MD 0.25 0 .2 F 11/08/2001 Pt became very fussy with a fever of 102F and was crying constantly in the office. The fever started early AM. She was hospitalized to r/o sepsis. Y Y 2 Y 11/07/2001 11/08/2001 1 CSF-neg; CBC-nl; UA-neg PVT PUB NONE NONE NONE 1
0177975 11/20/2001 WV 57 F Local erythema, edema and raise of temperature. Area measured 11cm by 10cm. 10/31/2001 11/01/2001 1 PVT UNK Migraine, CAD, Hyperlipidemia and nasal allergies. 1
0177976 11/20/2001 ME 1.0 0 1 F 11/15/2001 Nasal decongestion. Rash, fever, decreased appetite, 102 rectally. Y 10/31/2001 11/01/2001 1 PVT PUB Robitussin and Zantac 2ml BID NONE ME01040 1
0177977 11/20/2001 MI 0.3 0 .4 M 10/23/2001 Mother states they went out of town after immunizations. Child vomited 5 times all day Saturday, slept well Saturday night, no other problem or symptoms. Y 08/24/2001 08/26/2001 2 PVT PUB NONE NONE 1
0177978 11/20/2001 PA 1.5 1 .5 M 11/13/2001 Eighteen month old boy given Varivax on 10/29/2001. Presented 11/13/2001 with redness/puffiness at site of Varivax and left inguinal node. Skin with blanching erythema, not indurated, not tender; left inguinal node about 1.5cm in diameter, mobile; given Augmentin as unable to rule out early cellulitis/edemitis. Y Y 10/29/2001 11/11/2001 13 NONE PVT PVT NONE NONE NONE 1
0177979 11/20/2001 WV 69.0 69 F 11/12/2001 Marked swelling, warmth, edema shoulder to elbow. Y Y 11/06/2001 11/07/2001 1 PVT PVT NONE Penicillin and codeine 1
0177980 11/20/2001 NJ M Hives, hoarse throat... Went to ER. Y Y 10/24/2001 OTH OTH Cardura, Norvasc, Furosemide, Asprin, Metprolol, Clondine, Kdor-Con Cherries, IPV dye and Vasetec 1
0177981 11/20/2001 MD 1.0 1 .0 F 11/14/2001 Fever, papular rash, irritability and anorexia. Y 11/09/2001 11/11/2001 2 NONE PUB PUB NONE NONE NONE 1
0177982 11/20/2001 MN 17.0 17 F 11/19/2001 Swelling to 3 1/2 inches surrounding injection site with pink erythema warmth and tenderness. No fever, no lymphangitis. Y Y 11/09/2001 11/10/2001 1 NONE PVT PVT Thyroid None Down Syndrome 1
0177983 11/20/2001 SC 76.0 76 F 11/08/2001 Local reaction treated with benadryl, cool compresses, cortisone cream. Y 10/03/2001 10/04/2001 1 NONE PVT OTH Synthroid, potassium, lasix, calcium, vit E, Premarin, aldomet, lorazepam, ASA, benadryl, dilacor, Norvasc, lopid,, Cazacr, allopurinol, desyrel NONE 1
0177984 11/20/2001 SC 8.5 8 M Local rash erythematous maculopapular on R deltoid near and around Pneumovax site which erupted immediately after shot was given and responded well to Zyrtex 10mg and singular 5mg, benadryl. Y 11/14/2001 11/14/2001 0 NONE PVT OTH Mild viral illness Asthma, nasal allergies 1
0177986 11/20/2001 TX 67.0 67 F 11/12/2001 The patient's right upper arm had diffused induration, 100mm long x 40mm wide. The patient developed inflammation, redness and tenderness. The patient was treated with ice packs. Y 11/09/2001 11/10/2001 1 PVT PVT Methotrexate and Fosamax. Arthritis, hypertension and osteoarthritis. Allergic to Stadol. 1
0177987 11/20/2001 MI 4.0 3 M 11/14/2001 At 3:00 pm the patient's mother noticed the patient had a fever and the child had slowed down. The patient was treated with Tylenol. The patient complained of his head hurting him. The patient's temperature before the Tylenol was 104F. The patient had trouble breathing, his heart was beating hard, a possible seizure, his eye were up in his head, had a loss of consciousness and his temperature was up to 106F. The patient was taken to the hospital. The patient's temperature was 104F for the next 3 days. Two weeks later the patient was diagnosed with strep. The mother states the Dr says it was from Prevnar. Y Y 10/11/2001 10/11/2001 0 PUB PUB Amoxicillin Cold, afebrile and stuffy nose. Asthma ~Tetanus Toxoid (no brand name)~~0.00~In Sibling 1
0177988 11/20/2001 ME F 11/13/2001 Pt called, check out warm to touch, itching, red. Y 11/06/2001 11/08/2001 2 OTH PVT 1
0177989 11/20/2001 MI F 11/13/2001 Swelling and tenderness around injection site. Approximately 2 1/2"x3 1/2". Y 11/05/2001 11/06/2001 1 OTH PVT 1
0177990 11/20/2001 MI F 11/13/2001 Site bruised. Pt an Coumadin. No complaints. Y 10/24/2001 10/24/2001 0 OTH PVT Caumadin 1
0177991 11/20/2001 MI F 11/13/2001 Pt complained of itching, "Blotches on face and hands." Went into Church service. Over the counter Benadryl, Report OK by end of service. Y 11/04/2001 11/04/2001 0 OTH PVT Denies 1
0177992 11/20/2001 TX 39.0 39 F 11/14/2001 The patient experienced gradually increasing erythema, pain and itching at the injection site. The area is 3.5cm x 5cm. U 11/12/2001 11/12/2001 0 NONE PVT PVT Prozac, Alese and Glucophage XR. Diabetes Diabetes and depression. 1
0177993 11/20/2001 SC 1.08 1 .1 F 11/14/2001 The patient's mother states the patient had a fever of 103F and a rash on the day of vaccinations. The patient was seen in the ER and was diagnosed with a reaction to the vaccination. The mother states you could feel the rash. Y Y 05/08/2001 05/08/2001 0 PVT PVT NONE NONE NONE SC0157 1
0177994 11/20/2001 FL 71.0 71 F 11/03/2001 Swollen has and red arm from just above right shoulder to just below elbow for one week. Y 10/20/2001 10/21/2001 1 PUB UNK NONE NONE 1
0177995 11/20/2001 NC 48.0 48 F 11/14/2001 A nurse reported that an unidentified adult inadvertently received Prevnar vaccine. No adverse event had occurred at that time. No additional information was available as of the date of this report. Plan to revaccinate next year with Pneumovax 23. Y 10/12/2001 PVT OTH Dilantum 100mg, Dyaznac 50/25, Lorcet 10/650 QID, Effexor XR 150mg QD, Verelan 180mg, Combivent MDI 2 puffs QID prn. COPD, HTN, depression, seizure disorder Seizure disorder, depression, fibrocystic breast disease, smoker, hysterectomy, lumbar spine disease, HTN, fibromyalgia, SVT, pyelonephritis, ulcerative colitis and COPD HQ7232317OCT2001 1
0177996 11/20/2001 NC 48.0 48 F 11/14/2001 A nurse reported that an unidentified adult inadvertently received Prevnar vaccine. No adverse event had occurred at that time. No additional information was available as of the date of this report. Y 10/21/2001 NONE PVT OTH Dilantin; Dyazac; Lorcet; Effexor; Verclan; Combivent COPD, HTN, Depression, Seizure disorder Seizure disorder, Depression, Fibrocystic breast disease, Smoker, Hysterectomy; Lumbar spine disease, HTN, Fibromyalgia, SVT; Pyelonephritis, Ulcerative colitis; COPD 723217 1
0177997 11/20/2001 AK 68.0 68 M 11/09/2001 Pt received pneumococcal vaccine right deltoid on 11/06/2001. 11/08/2001 telephoned PHN, notes induration (5 cm by 3 cm) erythema, warmth, tenderness, chills w/o fever. PHN referred to MD, diagnosed with cellulitis and placed on Keflex 500mg bid for 10 days. No prior reactions to vaccines. Y U 11/06/2001 11/07/2001 1 NONE PUB PUB NONE NONE 1
0177998 11/20/2001 NY 36.0 36 F 11/15/2001 Generalized urticaria 3-4 hives after vaccine. Y 11/06/2001 11/06/2001 0 UNK PVT 1
0177999 11/20/2001 GA 58.0 58 F 11/13/2001 Taste of formaldehyde for two days. Extreme pain in neck. Could not lift or turn head. Strep throat. Y Y 10/18/2001 10/18/2001 0 OTH OTH NONE NONE 1
0178000 11/20/2001 MI 1.0 1 .3 M 11/12/2001 Unusual lump on left leg and refusal to mear weight 10/31/2001 AM onset transfer to ER where increased WBC greater than 24,000 and CRP equals 3.2; negative X-ray. Resolved in a few days. Repeat WBC. Y 10/30/2001 10/31/2001 1 increased WBC greater than 24,000 and CRP equals 3.2; negative X-ray. PVT PVT NONE NONE Questinable peanut semsitivity, 03/01 congestion, transent "wheeze" 1
0178001 11/20/2001 IA 0 .3 M 11/13/2001 Generalized rash including palms and soles. Raised reddened areas times 4 on thighs. Y 11/09/2001 11/09/2001 0 PVT PUB NONE Cold symptoms NONE 1
0178002 11/20/2001 NY 19.0 19 M 11/08/2001 Fever 101.3, headache, dizziness, rapid pulse, stomach ache, felt cold. Y 11/03/2001 11/03/2001 0 OTH PVT NONE NONE 1
0178003 11/20/2001 WI 54.0 54 F 11/12/2001 Flu vaccine given 11/09/2001 about noon. Sunday AM rash left ear, spread to back of neck, right ear and back of right hand, itching, burning. Treatment: Benadryl by mouth, rash stopped spreading, still there. N 11/09/2001 11/11/2001 2 PVT PVT Atenolol and Tricor NONE Sulfa, CAD, high cholesterol, HTN, arthritis. 1
0178004 11/20/2001 WI 26.0 26 F Developed fever with left arm becoming red and swollen from injection site to elbow. Arm was also very painful. Injection, 11/01/2001, Symptoms 11/02/2001 PM which progressively worsened, urgent care clinic 11/05/2001, diagnosis Staph infection and placed on antibiotics. Y Y 11/01/2001 11/02/2001 1 PUB PVT 1
0178005 11/20/2001 FL 33.0 33 F 11/13/2001 Following AM on waking, noticed reddened, hot, swollen, itchy area approximately 6"x4" upper arm, around site of injection. Took Benadryl with ice to area. Resolved in 3 days. Y 11/01/2001 11/02/2001 1 PVT PVT Lotrel, Selexa, Elavil, Noranth, Triliptal, Bus Par, Visceral. Bipolar 1
0178006 11/20/2001 MI 21.0 21 M 11/09/2001 Pt was given vaccination (Fluzore). In 10 minute pt was flushed skin warm to touch and slightly nauseous. Sat for 10 minutes and felt slightly better and wanted to leave. Returned in 1/2 hour still queasy and flushed. Administered Epipen. Felt better in 5 minutes. Pt remained better on 11/08/2001 as well. Y 11/07/2001 11/07/2001 0 OTH PVT NONE NONE NONE 1
0178007 11/20/2001 OR 77.0 77 F 11/12/2001 Rapid and irregular heartbeat after retiring approx 10pm - continuing through the night keeping me awake Y 10/15/2001 10/15/2001 0 OTH OTH 1
0178008 11/20/2001 DC 40.0 40 F 11/19/2001 In PM after flu shot, pt check out arm swelling and hives appearing called MD told her (according pt to apply hot/cold alternating, took Benadryl 1 hours h.s. next day arm (upper) very tender to touch. R t c/o rash at RN no see one, but saw small double scratch marks (scares of 3-4) Applied Hydro Cent cream. Y 11/14/2001 11/14/2001 0 OTH OTH No Reg, PRN for asthma, Therapy/Premarin. 1
0178009 11/20/2001 NY 55.0 55 F 10/29/2001 Nauseous, headache, aches - arms and legs, fast heart beat, sore throat, slight cough. Symptoms from 10/25/2001, 12:00 noon. Thorough weekend and still have headache and some aches.10/28/2001, 1PM. Y 10/25/2001 10/25/2001 0 OTH OTH 1
0178010 11/20/2001 NC 4.0 4 M 11/14/2001 Redness and swelling, no treatment necessary. 11/12/2001 11/12/2001 0 PVT PVT Otitis media - WOC 1
0178011 11/20/2001 NY 86.0 86 F 11/16/2001 Nausea, dizziness, chills, fever of 102 within 2 hours of receiving flu vaccination. Was prescribed Biaifin BID on 11/14/2001. Is improving. MD felt she had lung infection. Recovery - unable to see MD only spoke by telephone. N 11/09/2001 11/10/2001 1 PUB PVT Imdur, Baby Aspirin Albuterol, Atrovent and Flovent. Recovering from Bronchitis. Had been hospitalized. Chronic bronchitis, past history TIAs. Allergy to Keflex. 1
0178012 11/20/2001 TX 12.0 12 F 10/18/2001 At 10:20 AM on 10/17/2001 had swollen lips, vision problems, throwing up and dizzy. Called mom. Said she would take her to Dr. Cannot get call back from mom now. 10/16/2001 10/17/2001 1 PUB PUB NONE NONE TX01167 1
0178013 11/20/2001 TX 1.0 1 .4 F 10/15/2001 TC fr. MO, reporting right leg "swollen, red and warm and baby crying." 10/16/2001 TC to MO, child is improved after applying cool cloths. Given acetaminophen. No MD care sought. 10/18/2001 Improved, only slight swelling. Y 10/13/2001 10/15/2001 2 PVT PUB TX01166 1
0178014 11/20/2001 ND 3.0 1 .1 M 11/05/2001 Had Varivax 11/03/1999 at clinic. Broke out with chicken pox 11/03/2001. Y Y 11/03/1999 11/03/2001 731 PVT UNK NONE NONE ~Varicella (Varivax)~1~5.00~In Sibling 1
0178015 11/20/2001 ND 2.0 1 .3 M 11/02/2001 Broke out with chicken pox 11/02/2001. Y 03/10/1999 11/02/2001 968 NONE PVT PUB NONE NONE 1
0178016 11/20/2001 CA 23.0 22 F 09/24/2001 MMR given 09/14/2001 for negative titer (measles). Phone call to Employee Services 09/17/2001 with complaint of nausea and vomiting and URI symptoms. Seen in Employee Service 09/19/2001 and diagnosed pregnant (LMP 7/01). States didn't read consent. Follow up with OB-GYN 09/20/2001 regarding testing pt for fetal defects. OV to ES 09/26/2001 on medical leave, nausea, vomiting and abdominal cramps continue. Referred back to OB GYN. 11/12/2001 Note pt had elective TAB refusing appt for genetic counseling. Doing fine now. Y 09/14/2001 09/17/2001 3 Positive BHCG qualitative (blood) PVT PUB Albuterol NONE Asthma 1
0178017 11/20/2001 NJ 1.0 1 .2 F Erythematous maculopapular rash after 2nd dose, fever 12 hrs after 1st dose. Follow up states that: Do not have lot numbers for vaccine given Y 09/01/2001 09/01/2001 0 OTH OTH 1
0178018 11/20/2001 NJ 1.0 1 .3 U Fever x 2 days, body rash x 2 days. Follow up states: Do not have lot numbers to vaccine given U 09/10/2001 09/10/2001 0 OTH OTH 1
0178019 11/20/2001 NJ 1.0 1 .1 M Varicella - like reaction (lesion on leg). Follow up states: Do not have lot number for vaccine given. U 10/05/2001 10/05/2001 0 OTH OTH 1
0178020 11/20/2001 NJ 1.5 1 .5 F 10/06/2001 The patient developed swelling and warmth at the injection site. The patient had a local reaction to the vaccine in her left leg. Y 10/05/2001 10/05/2001 0 PVT OTH NONE NONE NONE 1
0178021 11/20/2001 FL 6.0 1 .1 F 11/15/2001 The patient developed lesions 3-6mm in size. Y 05/02/1996 11/13/2001 2021 PVT PVT 1
0178022 11/20/2001 OR 3.0 3 F 11/14/2001 Approximately 5 to 10 hours post vax, the patient developed hives over her face and neck. There were none noted on her trunk or extremities until approximately 20 to 30 hours later. The patient was treated with Benadryl. The patient's condition improved with further treatment. The patient was instructed to seek medical care if the symptoms return. Y 10/17/2001 10/17/2001 0 PUB PUB NONE NONE NONE 1
0178023 11/20/2001 DE 1.8 1 .9 M 10/01/2001 1 1/2 hours after immunization the patient had hives on his trunk, back and extremities. The evening and night of 09/28/2001 the patient had a fever of 103F. The patient's arm was red and swollen with spider like marks. The patient was treated with Benadryl and instructed to go to the ER if the symptoms persist. Two hours later the patient was sleeping and had only a rash. Y 09/28/2001 09/28/2001 0 NONE PUB PUB NONE NONE NONE 1
0178024 11/20/2001 MI 67.0 67 M 11/12/2001 Developed localized pain, tenderness, subsequent redness and swelling at the site of injection. Mild erythema and warmth with soft tissue swelling. No erythematous streaks. Y U 10/22/2001 10/22/2001 0 PVT OTH NONE NONE~Pneumo (no brand name)~~64.00~In Patient 1
0178025 11/20/2001 RI 55.0 55 F 11/13/2001 Rash, arthralgia, lympadenopathy. Y 10/23/2001 10/31/2001 8 PVT UNK 1
0178026 11/20/2001 MD 1.0 1 .0 F Fever 103' lasting 5 days, significant papular rash covering entire body, mild nasal congestion. swollen eyes, conjunctivitis or brassy cough. Y 10/23/2001 10/31/2001 8 PVT PVT NONE NONE NONE 1
0178027 11/20/2001 OH 6.0 1 .0 F 11/13/2001 Broke out with chickenpox on 11/09/2001 after sibling had chickenpox in October, 2001. Both were immunized with VARIVAX (same lot) on 03/27/1996. Mom wants lot investigated. Y 03/27/1996 PVT PVT NONE None except left otitis. NONE 1
0178028 11/20/2001 OH 46.0 46 F 11/13/2001 Hives on right leg around ankle and up to knee within 4 hours of shot. Y 10/15/2001 10/15/2001 0 OTH PVT 1
0178029 11/20/2001 OH 8.0 3 M 11/13/2001 Pt received VARIVAX 03/27/1996, broke out with chickenpox October, 2001. Sibling was immunized with same vaccine lot and also broke out with chickenpox on 11/09/2001. Moms wants lot investigated. Y 03/27/1996 PVT PVT NONE NONE 1
0178030 11/20/2001 UT 0.4 0 .3 F 11/12/2001 One time seizure lasted several minutes. Y Y 10/22/2001 10/29/2001 7 PVT PVT NONE NONE 1
0178031 11/20/2001 MI 1.5 1 .5 M 11/09/2001 The patient developed redness, swelling and itching at the injection site. Y 10/31/2001 11/01/2001 1 NONE PUB PUB Amoxicillin 1
0178032 11/20/2001 WI 1.5 1 .5 F 11/07/2001 The patient experienced redness and swelling at the injection site. The swelling was the size of a half dollar. The patient was observed in the clinic on 11/08/2001, and the swollen area was 3cm in diameter. Y 11/05/2001 11/07/2001 2 PVT PVT NONE NONE 1
0178033 11/20/2001 CT 51.0 51 M 11/19/2001 The patient developed a fever of 105F six hours after the vaccination. The patient had a large area of induration over the deltoid with erythema in an area 15cm x 10cm. Y 11/12/2001 11/12/2001 0 NONE OTH PVT Accupril NONE NONE 1
0178034 11/21/2001 MA 70.0 70 M 11/15/2001 The pt received Influenza 0.5ml, IM, LA at approx. 12:45. At 14:31, he was found DOA in his car at a local plaza. The fire dept report states that the pt was found slumped behind the wheel of his car. Pt was found to be pulseless/apneic and clutching a NTG bottle in his left hand. The pt was cold, mottled with pooling in the face and arms. Estimated down time 1/2 to 1 hours, according shopkeeper (maybe longer) who noticed car in space for extended time. No trauma noted. Pupils fixed/dilated, pooling in face secondary to position. Pt leaning over steering wheel; neck, arms stiff. Rigor secondary to pt pooling line in hands/forearms, extended down time. Cold, pale/mottled, dry; obvious morbidity. COD as per death certificate -- cardiorepiratory arrest Y 11/13/2001 N 11/13/2001 11/13/2001 0 PUB OTH History of by-pass surgery 1
0178036 11/21/2001 NY 5.0 5 M 12/27/2002 Previously dx'd with Autism in 10/99 and had no behavior or sensory problems X 1 year. Declassified in 8/01. Four days, post vax, reoccurrence of severe autistic behaviors including self-injury, screaming perseveration, animal-like behaviors, unsafe actions, altered sensory difficulties, increased attention deficit and hyperactivity. A rash was seen on abdomen the 2nd and 4th weeks after vaccine. Follow up reports states "Reoccurrence of Autistic Behaviors, including self-injurious behaviors- ? tics, infantile behaviors, excessive non-verbal gestures,increase in impulsive and unsafe behaviors, attention deficit,hyperactivity, urinary incontinence, mood swings." Y N 09/07/2001 09/11/2001 4 NONE PVT PVT NONE NONE Autism 10/99 but declassified in 8/01 Fever~DTP (no brand name)~1~0.00~In Patient 1
0178037 11/21/2001 NY 62.0 62 F 11/14/2001 On 11/9/01, received injection in left arm at 11:30. Approx. 1 hour later, arm was very red and swollen. Later, hives appeared in different areas of the body. Then fever, difficulty in breathing soon followed. Saw my PCP on 11/12/01 as an ER visit. Symptoms are starting to subside but breathing is still impaired. Hopefully making progress. Y Y Y 11/09/2001 11/09/2001 0 OTH OTH Voltaren; Lipitor; arava, E-vista RA 1
0178038 11/21/2001 ID 22.0 22 M 11/13/2001 Pt developed a mild rash on face, hours after shot. He broke out in hives, 24 to 36 hours later. Hives covered 60% of skin area. Went to ER and received treatment. Hives are slowly going away. Y Y Y 11/08/2001 11/09/2001 1 Allergic to Demerol. OTH PVT OTC sinus decongestant NONE 1
0178039 11/21/2001 IL 0.3 0 .4 F Pt had vaccines on 10/16/01; mom brought pt to clinic on 10/17/01 with a complaint of tremor and shaking. 911 was called. Y Y Y 10/16/2001 10/17/2001 1 OTH PUB NONE NONE NONE IL01049 1
0178040 11/21/2001 VT 0.2 0 .2 M 11/08/2001 About 10 minutes post vax, while heavily bundled and in infant seat, pt paled and turned blue. He appeared apneic. He was given blow by O2. He cried vigorously but appeared weak. Rescue squad was called, and pt was hospitalized overnight. He had no further trouble with color after about 1 hour. Y Y 1 Y 10/12/2001 10/12/2001 0 36 weeks gestation; TTNB (transient tachypnea of the newborn); Irregular heart rhythm (resolved) PVT PUB Mylicon prn EKG-wnl URI X 3 days; afebrile 1
0178041 11/21/2001 OH 89.0 89 F 11/15/2001 The patient's granddaughter called on 11/14/2001 to report the patient has tingling in her fingers and legs and joint aches less than 24 hours after vaccination on 11/07/2001. By day 7 the condition had resolved except for the right index finger is still tingly and the left leg is weak and achey. N 11/07/2001 11/08/2001 1 NONE PUB PUB NONE NONE 1
0178042 11/21/2001 IL 65.0 65 F 11/14/2001 The patient's reaction set in about 3 hours post vax. The patient experienced severe heart palpatations, nausea and general malaise. The patient was very sick for two full days. Y 10/22/2001 10/22/2001 0 PVT PVT NONE 1
0178043 11/21/2001 ID 29.0 29 F 09/26/2001 The patient called the clinic and reported she developed "tightness of the chest" shortly after the shot was administered. The patient states she had the same reaction one week ago after she received her fist dose. The patient failed to report this to the nurse during the medical history inquiry. The patient saw the PMD last week and he told her it was inflammation of cartilage between the ribs. The patient was treated with an anti-inflammatory. U 09/26/2001 09/26/2001 0 PUB PVT NONE Head cold. Allergic to hazel nuts. ID01050 1
0178044 11/21/2001 IL 27.0 27 F 11/12/2001 The patient complained of tenderness at the left base of the neck, the left lateral chest wall and upper arm. After a medical exam, the patient was prescribed Darvocet N-100. Y Y 11/08/2001 11/09/2001 1 OTH PVT NONE 1
0178045 11/21/2001 MN 1.0 1 .0 F 05/14/2001 Eight days post vax the patient developed a fever of 102-105F. The patient was seen in the Dr's office and it was assumed she had a viral illness. The patient was seen in the ER with some bluing of the lips and a fever. There were no other symptoms. The patient was diagnosed with a fever of undetermined origin. Y 02/09/2001 02/17/2001 8 UA and CBC = wnl PVT PVT NONE NONE 1
0178046 11/21/2001 VA 43.0 43 M 11/20/2001 The patient experienced itching, redness and swelling from the injection site on the left arm to the elbow. This lasted 3 days. Y 11/16/2001 11/17/2001 1 NONE OTH MIL Lipitor and vitamins. NONE NONE 1
0178047 11/21/2001 OH 4.0 1 .0 F 11/12/2001 The patient experienced varicella on her face, legs, head and trunk and wheezing. The patient received symptomatic treatment. Y Y 02/26/1998 11/12/2001 1355 PVT PVT NONE 1
0178048 11/21/2001 WI 11.0 11 F 11/19/2001 Post vax the patient became weak and pale. Was still weak the following day. On 11/09/2001 the patient was back to normal. Y 11/07/2001 11/07/2001 0 NONE OTH PUB NONE 1
0178049 11/21/2001 CA 54.0 54 F 11/20/2001 On 11/14/2001 the patient developed swollen and painful lymph nodes behind the ears. On 11/19/2001 a rash appeared on the trunk, arms and legs. U 11/06/2001 11/14/2001 8 PVT PVT Premarin, Dyazide and K-dur NONE HTN and diabetes. 1
0178050 11/21/2001 AK 18.0 17 M 09/25/2001 The patient experienced a fever, extreme tiredness, slept 24 hours, has pain, sensitivity to touch, sore throat and abdominal pain. Y Y 08/20/2001 08/20/2001 0 Elevated WBC, Negative throat culture. PUB PUB NONE NONE AK200166 1
0178051 11/21/2001 AK 2.0 2 .0 F 10/22/2001 Post vax the patient's mother noticed a splotchy, itchy rash at approximately 8:30 - 9:00PM. The patient slept well. The patient was seen by the Dr on 10/19/2001 and treated with Benadryl. Y Y 10/18/2001 10/18/2001 0 NONE PVT PUB NONE NONE NONE AK200167 1
0178052 11/21/2001 MN 41.0 41 F 08/08/2001 The patient experienced extreme redness and heat that started in the face, moved to her ears, down her neck, to her chest and then to her arms and hands. The patient took one Benadryl while the hives were starting down her neck. The patient took a second capsule while the hives were starting down her arms. Within 1 1/2 hours later the redness and heat started to subside. Y Y 08/07/2001 08/08/2001 1 PUB PVT Multivitamins and calcium. NONE Allergic to penicillin, ceftin and septra. 1
0178053 11/21/2001 MN 54.0 54 F The patient developed severe swelling and redness at the injection site, preceeded by nausea, flushing and faintness. The upper arm was swollen 3x the normal size and erythematous. 24 hours later the patient was still markedly swollen with warmth and redness. Y 02/28/2001 02/28/2001 0 PVT PVT Prinizide, Lipitor and Premarin. NONE Aortic aneurysm, hypertension and hyperlipidemia. 1
0178054 11/21/2001 ID 5.0 5 F 10/08/2001 The patient developed a raised, welted area on the thigh which increased in size for 3 days. The center was white and surrounded by beet red. The patient experienced pain. The patient was treated with ice and Tylenol. Y 06/03/2001 06/05/2001 2 PVT PVT NONE NONE NONE ID01053 1
0178055 11/21/2001 ID 14.0 14 F 10/18/2001 The patient developed cellulitis of the left deltoid. The patient had redness and swelling of the injection site. The patient also experienced a headache and vomiting. Y U 10/05/2001 10/06/2001 1 PUB PUB Singulair and Albuterol MDI. Asthma ID01054 1
0178056 11/21/2001 ID 43.0 43 F 10/09/2001 The patient experienced swelling in the right axillary after the injection. Y 10/05/2001 10/06/2001 1 NONE PUB PVT NONE NONE NONE ID01055 1
0178057 11/21/2001 ID 29.0 29 F 10/15/2001 The patient started having pain in the left arm and armpit on 10/12/2001. The patient called on 10/15/2001 and stated that the left arm pain was gone but the left armpit was still sore. The patient denies nausea or fever. U 10/10/2001 10/12/2001 2 PUB PUB NONE NONE NONE ID01056 1
0178058 11/21/2001 ID 34.0 34 M 10/18/2001 Post vax the patient awoke from with nausea and vomiting. When the patient went to the bathroom, he became very dizzy and blacked out. The patient complained of left arm pain. The patient was treated with ibuprofen. Y U 10/17/2001 10/18/2001 1 PUB PVT NONE Allergic to green peppers. ID01059 1
0178059 11/21/2001 ID 79.0 79 F 10/24/2001 The patient experienced urticaria, 4" x 3" at the site of injection. Y 10/15/2001 10/16/2001 1 PVT PUB Accupril, Premarin and Fosamax. NONE Hypertension and osteoporosis. ID01061 1
0178060 11/21/2001 ID 2.0 2 .5 M 10/31/2001 On 10/28/2001 the patient was crying and had a temperature of 101.9F. On 10/29/2001 the patient was having trouble focusing her eyes. On the afternoon of 10/29/2001 the patient developed a rash on his shoulders and the inside of his legs. On 10/31/2001 The patient temperature was 100F. The patient had no rash, no headache and no trouble focusing. Y 10/22/2001 10/28/2001 6 PUB PUB NONE NONE NONE ID01062 1
0178061 11/21/2001 ID 17.0 17 F 11/02/2001 10/24/2001, PM, the patient experienced swelling and pain. On 10/25/2001 the patient had an exam. The patient had a hot, swollen, reddened area, 3cm x 1 cm at the injection site. Y Y 10/18/2001 10/24/2001 6 NONE OTH UNK Alberterol and Serevent. Cold Allergic to hay and animal dander. Asthma. Arm swell~Td Adsorbed (no brand name)~1~13.00~In Patient ID01063 1
0178062 11/21/2001 ID 43.0 43 F 10/17/2001 The patient experienced mild systemic symptoms but they were not reported until the following week. On 09/18 the patient feverish. On 09/20/2001 the patient experienced lower extremity stiffness, soreness and swelling. On 09/21/2001 the patient developed a raised, red, painful rash on the palms of her hands. On 09/24/2001 the patient called to report her symptoms. The patient Health Dept called. The patient was excluded from work until 10/03/2001. The patient went to an infectious disease Dr on 10/02/2001. Y Y 09/05/2001 09/18/2001 13 Rubella IgM + after vaccine. PVT PVT NONE Allergic to sulfa. ID01058 1
0178063 11/21/2001 TX 1.3 1 .4 M 11/07/2001 The patient developed angioedema and urticaria. Y Y 11/06/2001 11/06/2001 0 PVT PVT Omnicef and Histussin HC. NONE 1
0178064 11/21/2001 TX 15.0 15 M 10/15/2001 The patient was admitted to the hospital on 09/11/2001. The patient was running a fever, 104-105F, could not walk, and could not eat. The patient complained of being tired and weak on 08/11/2001. On 08/27/2001 the patient was taken to minor care. The patient was taken to the ER on 08/29/2001 with arthritis and fluid around his heart. Annual follow up received on 2/07/2005 states: "Doctors have told us that they do not know if pt is recovered or if the problems will reoccur - Pt is exempt from vaccine immunizations of Hep B in the future - doctors told us that and the vaccine was the cause of all his illnesses." Y Y U 08/10/2001 08/11/2001 1 WBC = 1.4 PUB UNK NONE TX01169 1
0178065 11/21/2001 TX 4.0 4 M 10/05/2001 The patient developed a red, swollen area to the left deltoid. The area was warm to touch. the patient was treated with Benadryl and Tylenol. The patient's symptoms began 10/04/2001. The patient will go for follow up on 10/08/2001. U 10/03/2001 10/04/2001 1 NONE PUB PUB NONE NONE NONE TX01170 1
0178066 11/21/2001 TX 5.0 5 M 10/17/2001 The patient had a low grade fever on the day of the vaccination. The patient's left arm was red, warm and painful. On 10/17/2001 the patient is afebrile, playful, his arm is still warm but soft and natural feeling. Grandmother to call the Health Dept in a few days to report the patient's condition. Y 10/15/2001 10/15/2001 0 PUB PUB NONE TX01171 1
0178067 11/21/2001 MN 33.0 33 F 07/13/2001 Late January or early February the patient received a chemical burn to her hair. She saw her physician, who gave her a tetanus and varicella vaccine, plus two antibiotics. Four weeks later the patient developed shingles on her scalp. The patient presently has a hair follicle infection and has not recovered. N 01/25/2001 01/25/2001 0 Blood tests and x-ray, results pending. PVT UNK 1
0178068 11/21/2001 PR 0.2 0 .1 F 11/08/2001 The patient had a prolonged crying spell. Y 11/02/2001 11/02/2001 0 NONE PVT PVT NONE NONE 1
0178069 11/21/2001 IL 10.0 10 F 10/29/2001 As soon as the patient got home from the clinic she was very listless, sleepy and vomited several times. This lasted 4 to 5 days during which her parents took her to the ER several times. They reported that the ER performed several tests which were all negative. They found no cause for her symptoms. After approximately 5 days she was able to start eating and she recovered. Y Y 09/04/2001 09/04/2001 0 Blood tests and x-rays - wnl PUB PUB NONE NONE NONE IL01046 1
0178070 11/21/2001 IL 1.0 1 .0 M 10/22/2001 The patient experienced a pin point, flesh colored, red abdomen and back. The patient was treated with Amoxicillin. U 10/16/2001 10/22/2001 6 PVT PUB NONE NONE IL01047 1
0178071 11/21/2001 MI 4.0 4 F 10/24/2001 The patient's mother called on 10/24/2001 to state that the patient had an allergic reaction to vaccines given 10/15/2001. She developed a rash of pimples at the injection site and her Mom took her to the family Dr who started this was an allergic reaction. Y Y 10/15/2001 NONE PUB PUB NONE NONE NONE MI2001088 1
0178072 11/21/2001 MI 35.0 35 F 11/15/2001 On 11/05/2001 the patient called to report her entire left arm is achy from the MMR vaccine. The Dr advised treatment of Tylenol and a warm compress. On 11/06/2001 the patient's pain was resolving but not enough to return to work. Y Y 11/01/2001 11/02/2001 1 NONE PUB PVT NONE NONE NONE MI2001090 1
0178073 11/21/2001 WA 1.4 1 .3 F Nine days after the vaccine, the patient awoke from her afternoon nap with a fever of 103.5F. The patient was taken to the dr and nothing was found to be wrong. The next day she was fine. Y Y 09/04/2001 09/13/2001 9 PVT OTH NONE NONE 1
0178074 11/21/2001 OH 1.6 1 .6 M 11/12/2001 The patient developed a local reaction, 2 1/2" swelling and erythema of the left deltoid two days post vax. The patient's mother is to monitor and apply warm compresses. The patient was treated with Benadryl. Y 11/07/2001 11/09/2001 2 NONE PVT PUB Claritin, Orapred and Albuterol. Asthma 1
0178075 11/21/2001 VA 10.0 10 M 11/15/2001 30 to 45 minutes after the vaccine was administered, the patient developed facial flushing, increased heart rate and complained of his throat swelling and a sense of anxiety. The patient was examined by the Family MD and was diagnosed with a reddened rash on his cheeks. The patient was treated with Decadron and Allegra. Y Y 10/26/2001 10/26/2001 0 Strep culture of throat - negative. BP 90/70, Pulse 100, Temp 98F all wnl. OTH PUB NONE NONE NONE 1
0178076 11/21/2001 NV 1.0 1 .0 M 11/14/2001 One week post vax the patient developed a rash on both arms at the sites of injection. Y 11/06/2001 11/13/2001 7 NONE PVT PUB NONE NONE NONE 1
0178077 11/21/2001 NY 56.0 56 F 11/14/2001 On 11/12 post vax, the patient experienced aching pain in her legs, arms, back and collarbone. The patient took Tylenol. The patient called her MD, who feels the patient is reacting to the vaccine. On 11/14/2001 the patient feels better. Y 11/12/2001 11/12/2001 0 PUB PUB MOBIC NONE Arthritis, asthma, allergic to penicillin, sulfa, erythromycin and ASA. 1
0178078 11/21/2001 OR 27.0 27 F 11/15/2001 Starting the second day after the vaccination, the patient's body aches and she has a fever of 103.5F. These symptoms lasted until 6 days after the vaccination. N 11/09/2001 11/10/2001 1 OTH PVT Prednisone Abdominal pain. Allergic to iodine and sulfa. 1
0178079 11/21/2001 FL 25 M 11/14/2001 Fever 101.7, redness, swelling and pain at injection site. N 11/11/2001 11/12/2001 1 NONE PUB UNK NONE 1
0178082 11/21/2001 NV 33.0 33 F 11/09/2001 4 hours, post vax, the pt states she had difficult breathing and a high fever. Spoke with MD that she had Hep-A vaccine and took antihistamine. Within minutes, condition improved. No further problems. Y 10/22/2001 10/22/2001 0 NONE PUB PUB NONE NONE NONE 1
0178083 11/21/2001 NJ 0 .1 M 11/14/2001 Child cried a lot for 5 days, post vax. Y 08/13/2001 08/13/2001 0 NONE PVT PVT NONE NONE 1
0178084 11/21/2001 MS 1.0 1 .0 F 11/14/2001 Seizures-11/13/01; bilateral otitis media; chest congestion. Y Y 11/12/2001 11/13/2001 1 PUB OTH NONE NONE 1
0178085 11/21/2001 MS 41.0 41 F 11/14/2001 Pt developed pain, redness and swelling at the injection site and fever and myalgias. Y 11/05/2001 11/06/2001 1 Mild anemia (chronic); Steroid induced diabetes of recent onset; elevated WBC which was felt to be secondary to steroids. PVT PVT colchicine; Zantac; Effexor XR; Zyrtec; prednisone Allergy to penicillin and sulfa; possible Behcet's Syndrome vs Lupus 1
0178086 11/21/2001 WA 5.0 5 M 11/15/2001 On 11/13/01, the child's aunt called triage nurse regarding his arm being swollen and having a fever. He came to ER on 11/14/01 with right arm red and swollen from elbow to upper to upper arm. Rx'd ibuprofen, Benadryl and cool compresses. He had no fever or systemic symptoms. Y U 11/12/2001 11/13/2001 1 NONE PUB PUB NONE Family history of PCN allergy; esotropia (crossed eyes) Small lump at injection site~DTaP (no brand name)~3~4.00~In Patient 1
0178087 11/21/2001 CA 32.0 32 F 11/10/2001 Pt developed a rash, fatigue and nausea, post vax. Y Y 10/16/2001 10/16/2001 0 NONE OTH PVT NONE NONE History of breast mass and a history of cardiomyopathy 1
0178088 11/21/2001 PA 0.75 0 .8 F 11/14/2001 Reported bumps over body X 3 weeks, pruritic and spreading today. Papules and vesicles (about 30) on trunk and still pruritic. Afebrile. No known exposure to Chickenpox. Y 05/29/1996 10/01/2001 1951 NONE PVT OTH UNK UNK 1
0178089 11/21/2001 OH 1.08 1 .1 M 11/08/2001 Pt developed a temperature to 101.8F (rectally) on 11/8/01. Y 10/29/2001 11/08/2001 10 PVT PVT NONE Allergies 1
0178090 11/21/2001 OH 11.0 11 F 11/07/2001 Complained of heart burning, sore throat, rash, itching, faint, wheezing loud, swollen eyes. Epi .3 cc SQ and 25mg Benadryl given. Y Y 11/07/2001 11/07/2001 0 NONE PUB PUB NONE NONE NONE 1
0178091 11/21/2001 CA 11.0 11 F 10/25/2001 Pt developed urticaria and angioedema and was given Benadryl and prednisone. Y 10/08/2001 10/08/2001 0 PVT PUB 1
0178092 11/21/2001 CA 84.0 84 M 11/14/2001 Pt developed pain, swelling and redness the size of an orange, early PM on 11/13/01. By late PM on 11/13/01, it was the size of his thigh. By early AM on 11/14/01 to late PM, it was down below his elbow but less swelling. Treated with a cortisone shot. Y U 11/13/2001 11/13/2001 0 PVT PVT Oxycontin; Lotrel; Neurontin; Pravachol; Desipramine; HCTZ Recovery from shingles Allergy to ampicillin, PCN and clindamycin 1
0178093 11/21/2001 IN 1.0 1 .1 M 11/07/2001 Rash all over body starting about a week ago after immunizations. He had a low grade temperature. Raised irregular blanchy rash on chest and back, has a few on his arms. Y U 10/25/2001 11/06/2001 12 Left otitis media with viral exanthem. UNK UNK UNK NONE IN200125 1
0178094 11/21/2001 IN 24.0 25 M 10/20/2001 Pt left the clinic and returned 5 minutes later. Wife stated she drove 1 block and her husband passed out. Pt was very diaphoretic, showing seizure-like activity. He could not answer questions. Called 911 and pt was in his automobile during this time; then went to hospital in private car per recommendation of EMT's. Follow-up call stated that pt all ok. Y Y 10/30/2001 10/30/2001 0 UNK PUB PUB NONE NONE IN200126 1
0178095 11/21/2001 KS 0.25 0 .2 M 11/16/2001 Symmetrical, dark red flushing of skin, distally (appearing at bootie top to upper thigh to proximally.Superficial leg veins pronounced. Increased warmth to touch. Onset within 1 minute of completion of last injection. (Prevnar) Y 10/22/2001 10/22/2001 0 PUB PVT 1
0178096 11/21/2001 NY 40.0 40 F 11/17/2001 Pt felt weak, nausea, dizziness 1/2 hour with vaccine. She ate a meal, vomited, then felt dizzy and weak. I had her lay down 1/2 hour. Pt felt better wanted to leave, she then started to walk. I accompanied her. She fainted second time. Discharged at 9 PM from ER with diagnosis of anemia and dehydration. Y Y 11/17/2001 11/17/2001 0 OTH PVT cough syrup antibiotic(unsure type) 2 weeks with surgical procedure. No known allergy. History of anemia, hypertension. 1
0178097 11/21/2001 MI 49.0 49 F 11/07/2001 Symptoms: 10/26/2001 "Woke up with aches and pain (all over) with sore throat". No fever, lasted 3 days" 3 days later developed, "coughing, sore throat, hot and cold temperature 100 degree. No aches" took OTC Tylenol/cold for 5 days. Saw MD 11/07/2001. Y Y 10/25/2001 10/26/2001 1 PUB UNK Tenormin, Dyazine, Lescol Hypertension 1
0178098 11/21/2001 FL 31.0 31 M 11/06/2001 Shot administered 11/2/01, headache soon followed and lasted until 11/3/01 late evening rash broke out on 11/4/01, applied benadryl cream to site of rash and took benadryl allergy pills. Y 11/02/2001 11/02/2001 0 NONE OTH OTH MVI NONE allergy to cat dander 1
0178099 11/21/2001 NC 1.0 1 .4 F 10/10/2001 Vaccine given 7/13/01 on 7/15 pt adm to ED for swelling from knee up since receiving vaccination. Has been fussy. (LLE) hot to touch. treatment: ibuprofen, cool compress. Y U 07/13/2001 07/13/2001 0 PVT OTH NONE UNK UNK 1
0178100 11/21/2001 NJ 64.0 64 M 11/18/2001 Pt check out itchiness of bilateral arms. Abdomen and back area. Pt also noticed small red rash on above areas. Pt took Benadryl 25 mg. by mouth. N 11/12/2001 11/12/2001 0 PUB PVT NONE Allergic to PCN, keflex with left ankle osteomyelitis. 1
0178101 11/21/2001 AK 77.0 77 M 10/25/2001 Felt very hot, no perspiration, felt like he was burning up. Fast respiration, shivering, felt he was hallucinating. Felt weak the next day but otherwise normal. It was very scary. had felt chilled 10/22 in the evening. Y 10/23/2001 10/23/2001 0 NONE PUB PUB Xalatan drops Felt chilled the night before glaucoma, allergic to tomoptic drops AK200169 1
0178102 11/21/2001 MN 1.0 1 .0 M 06/12/2001 Fever started 8 days after the shots & was as high as 102.2F. Two days after fever started he got a rash that spread that day over his entire body. The rash was bright red raised. It did not seem to bother him. The fever continued for 5 days and the rash started to fade after a week but was visible 2-3 weeks. Y Y 05/29/2001 06/07/2001 9 NONE PVT OTH NONE NONE NONE 1
0178103 11/21/2001 ID 0.6 0 .4 F 10/19/2001 Following immun. that evening child had scream type cry for greater than 3 hours and was unconsoleable. Y 07/25/2001 07/25/2001 0 PUB PVT ID01060 1
0178104 11/21/2001 ID 1.08 1 .1 M 10/04/2001 MMR given 9/27/01. 10/1 pm pt had 99 degree temp, small area of red flat rash to back (approx 3" across).10/2 - temp 102F - 102.5F, vomited x 1, rash across back now. 10/3 temp 100F, continued with malaise. 10/4 - much improved with temp at ? - rash spread now to front of face. Y 09/27/2001 10/01/2001 4 NONE PUB PUB NONE NONE NONE ID01052 1
0178105 11/21/2001 WA 0.3 M 09/27/2001 Fever 100F after 1st Prevnar immunization, Temp >102F after 2nd Prevnar. Y PVT PUB ID01051 1
0178106 11/21/2001 TX 69.0 68 F 11/09/2001 2 1/2 hours, post vax, I had chills lasting for several hours. The arm, from injection site to elbow, was hot, edematous and red. The MD saw area on Monday. Rx'd Biaxin 500mg BID X 10 days. The arm was very painful for 1 full week. Y Y 10/27/2001 10/27/2001 0 OTH OTH Zinc; Premarin; Protonix NONE NONE 1
0178107 11/21/2001 TX 25.0 25 M 11/08/2001 Ill feeling about 2 1/2 hours, post vax. Pain was noticed to the arm around 22:00. The next AM, noticed redness at the injection site of pneumococcal vaccine. States he also had a fever (generalized). Went to health dept to see nurse but did not wait as the clinic was busy. Saw someone at a "walk-in" clinic. He had a fever of 100.7F and was started on an antibiotic 1 BID X 10 pills. Feels a little better. Temperature is now 99F. Redness at the injection site, 4 1/2" X 2 1/2", warm and slightly raised. Told to call back if any questions or problems. Given clinic number and nurses name. Y Y 11/05/2001 11/05/2001 0 NONE PUB PUB NONE NONE NONE TX01173 1
0178108 11/21/2001 TX 48.0 48 F 11/02/2001 Pt developed slight discomfort at the site of injection the next day, worsening a little each day. More pain when she lays on the side. No redness or edema. Y 10/29/2001 11/02/2001 4 PUB PUB Flonase; Nexium; Accolate; Estratest; Hydrocodone NONE Low platelets; Splenectomy on 8/21/01; Allergic to Phenergan TX01168 1
0178109 11/21/2001 TX 58.0 58 F 11/05/2001 Per pt, she states that about 20 minutes, post vax, she had onset of pain (severe) to left arm which lasted through the night. Pain subsided by the AM, the next day (10/30/01). No pain today. Also had slight swelling which has subsided since she started using warm packs. Y 10/29/2001 10/29/2001 0 PUB PUB Vasotec, daily HTN; Allergic to PCN and ASA; No birth defects TX01172 1
0178110 11/21/2001 DE 53.0 53 F 11/15/2001 At 03:00 AM, on 11/15/01, the pt noted hives and complained of itching on her face, neck and upper torso. Rx'd Claritin D 1 QD PO. U 11/14/2001 11/15/2001 1 OTH PVT BCP's; Acitex NONE NONE 1
0178111 11/21/2001 IL 29.0 29 F 10/31/2001 Pt felt fine after receiving flu shot; raked leaves and took her usual evening nap but woke up to get ready for work and felt very weak and throat was dry. Upon arriving at work, she felt warm and her heart was racing (BP-117/90; Pulse-135 and irregular) which is very unusual. Her legs felt rubbery and she was taken to the ER at 23:59, midnight. Her temperature was 101.6F, she was cool to touch and body was aching. She is recovering. Y U 10/30/2001 10/30/2001 0 BP was 117/90 and then 117/70; Pulse was 135 and irregular and then decreased to 100; O2 sats were 93%; Temperature was 101.6F and then 102.5F; UA-neg; Metabolic Panel-OK; CXR-Clear OTH PUB Birth control pills NONE NONE IL01048 1
0178112 11/21/2001 WA 0.4 0 .2 F 11/15/2001 Pt had a high-pitched and prolonged "different" cry, post vax. On 11/13/01, DT was given instead and no adverse reactions were noted by parent this time. This child has a twin sister. Y 09/10/2001 09/10/2001 0 PVT PUB NONE NONE NONE 1
0178113 11/21/2001 TX 30.0 30 M 11/13/2001 Pt's arm became hot and inflammed on the afternoon, post vax. A rash appeared shortly afterwards, becoming pustular and traveling down the entire left arm. Rash covered entire arm and was very inflammed and uncomfortable. Pt went to PCP on 10/22/01 and was given an injection of Kenalog and a Medrol Dosepak. At completion of Dosepak, all inflammation had disappeared but evidence of the rash still remains as of 11/13/01. Y Y 10/19/2001 10/19/2001 0 NONE PVT PVT NONE NONE NONE 1
0178114 11/21/2001 CA 0.2 0 .2 M 11/09/2001 Mother says that baby was seen for 1st shots and told to sign papers to get shots including Rotavirus. The next day, after feeding, the baby began to vomit and was having diarrhea approx. 15 minutes afterwards. Repeated episodes after each feeding. Went back to clinic and was given a container to collect stools. Was later told that it was not diarrhea and formula was changed. He continued to have episodes. Called HC and seen there on 11/9/01. Y U 10/10/2001 10/11/2001 1 Pt's mother says she collected stools for clinic lab and was told that baby had no diarrhea/problem found in stool. PVT PVT NONE NONE 1
0178115 11/21/2001 CA 35.0 35 F 11/01/2001 24 hours post vax, the pt was plagued by extreme achiness, headache, very upset stomach, no fever for a duration of 48 hours. Y 10/16/2001 10/17/2001 1 N/A OTH PVT Depo Provera NONE Type II Diabetes 1
0178116 11/21/2001 CA 39.0 39 F 11/07/2001 Pt experienced diarrhea and fatigue for a duration of one day. Y 10/16/2001 10/17/2001 1 N/A OTH PVT Tri-Levlen NONE NONE 1
0178117 11/21/2001 OH 54.0 54 F 11/15/2001 Pt received flu shot in right arm on 11/14/01, Pneumonia in left arm on the same day. Pt awoke early the next morning with pain and swelling of right upper arm. Pt presented to physician with 6" X 4" of redness and warmth. Treated with Epinephrine and Depomedrol. Y 11/14/2001 11/15/2001 1 PVT PVT Verapamil; Aldactone, Avapro, Allegra Htn, chronic hepatitis C; Allergies 1
0178118 11/21/2001 CA 1.5 1 .5 F 11/13/2001 Pt experienced a red papular with no other symptoms. Y N 11/12/2001 11/12/2001 0 N/A PVT PVT NONE NONE NONE 1
0178119 11/21/2001 IL 80.0 80 F 11/14/2001 Cellulitis of right arm. Y 10/10/2001 10/11/2001 1 PVT OTH Lipitor; Fosamax; Tenormin; Flurinot; Zoloft Previously resolved pneumonia 1
0178120 11/21/2001 WA 20.0 20 F 11/06/2001 Received flu vaccine at 9 am on 11/02/01, 2 hours later started sneezing and became sinus congested. In another 3 hours she had itching eyes and than started to feel more and more body itching. Did not develop rash or have trouble breathing. Around 4PM took a Benadryl tablet and started to feel better. She reported this on 11/5/01 at which time she was feeling fine. Y 11/02/2001 11/02/2001 0 PVT PVT Allergy - milk, wheat 1
0178121 11/21/2001 PA 30.0 30 F 11/15/2001 Intramural reaction diffuse pruritis. Y Y 10/22/2001 10/23/2001 1 PUB PVT Sere Vent, azconical, PPD(Tinc Test) NONE Asthma 1
0178122 11/21/2001 WA 16.0 16 F 11/14/2001 Oblong, irregular pink rash that appears below vaccine site. Tender with palpation. Discomfort at the site of redness. Diffuse ill defined pinkness on the left shoulder. Y 11/02/2001 11/03/2001 1 OTH PVT Zorvax Total Anomalous Venous Repair. 1
0178123 11/21/2001 IL 0.3 0 .2 F 11/01/2001 About 30 minutes with DTAP/IPV/Hib-HepB/Prevar baley, who immediately feel asleep with the shot, arrival at home. Parents found her to be limp and were not able to awaken her for aleast 2 minutes even than continued to sleep for most of that day. Y 09/06/2001 09/06/2001 0 PVT PVT NONE NONE NONE 1
0178124 11/21/2001 NY 67.0 67 F 11/13/2001 Black and Blue injection point. Total arm became infected every lymph gland. Shot should not have been given in breast surgery side, or given mega dose of antibiotic for 7 days. Very painful and lost use of arm due to such carelessness. Y Y 10/29/2001 10/30/2001 1 PUB UNK 1
0178125 11/21/2001 CA 3.0 3 M 11/14/2001 Daily hives times 7 days. Y 11/06/2001 PVT PVT NONE NONE Neurofibromatosis. 1
0178126 11/21/2001 OH F 11/22/2001 Local reaction to DTAP swelling right leg - vastus lateral. Mom to monitor decrease, use warm compresses. Y 11/08/2001 11/14/2001 6 PVT UNK Sickle Cell trait. 1
0178127 11/21/2001 IA 68.0 68 F 11/08/2001 Pt starts received flu and pneumonia vaccine in left arm 10/23/01. Later that day arm became painful, swollen and unable to raise arm. Seen by Dr. on 10-24-01. Prescribed 10d course of Cephalexin and Zyrtec. Pt has completed meds. Pt states swelling is down, gets out of breath, feels weak sometimes. Y N 10/23/2001 10/23/2001 0 PUB PVT Emphysema/COPD ~Tetanus Toxoid (no brand name)~1~30.00~Patient 1
0178128 11/21/2001 AK 58.0 58 M 11/07/2001 One day post vax left upper arm became pink, swollen and warm to touch from shoulder to elbow. Treated with oral Benadryl and ice. Pt seen by ER physician to make sure it was not cellulitis. Pt continued to treat with oral Benadryl and swelling started to decrease. Six days post vax the pt is doing much better but still some swelling present. Y N 11/01/2001 11/02/2001 1 NONE PUB PUB NONE bronchitis, pneumonia, other respiratory problems AK200170 1
0178129 11/21/2001 WY 1.0 1 .1 M 11/14/2001 Pt experienced a mild form of rash without vesicles. Diffuse red papules lasting 6 days after usual prodrome. Y 10/22/2001 10/30/2001 8 N/A PVT PUB NONE right acute otitis media NONE 1
0178130 11/21/2001 TN 1.4 1 .3 F 11/14/2001 Febrile seizure 9/7 after shots given. That day went out of town and went to ER. Was behind on shots and going out of the country. Y Y 09/07/2001 09/07/2001 0 Blood cultures and urine culture negative PVT PVT NONE NONE NONE 1
0178131 11/21/2001 IL 46.0 46 F 11/13/2001 Localized erythema with induration 80 by 60 mm. Treated with Benadryl and Motrin. Y Y 11/07/2001 11/08/2001 1 PVT PVT NONE NONE 1
0178132 11/21/2001 TX 1 .0 F 11/16/2001 Less than 24 hours after pt received immunization she had what was described as generalized seizure like activity. Y Y 11/07/2001 11/07/2001 0 CT (Negative) MIL MIL Tylenol as needed Sniffles NONE 1
0178133 11/21/2001 UT 39.0 39 F 11/13/2001 Rash and swelling at injection site. Y 10/23/2001 10/24/2001 1 PUB PVT Prozac 1
0178134 11/21/2001 MA 1.08 1 .1 M 11/14/2001 On 11/07/2001 pt developed fever for 3 days. On 11/09/2001-11/11/2001 developed rash, observe. Phone follow up 11/13/2001 doing okay. Y 10/30/2001 11/07/2001 8 PVT PUB URI, vomit diarrhea for 3-4 days Horseshoe kidney with hydronephrosis, Laryngotracheomolaria 1
0178135 11/21/2001 MA 3.0 3 F 10/09/2001 At approximately 4:00 PM the next day pt experienced erythema, swelling at injection site. A rash appeared on both wrists and dorsal. 8PM T384 Y 10/07/2001 10/08/2001 1 N/A PVT PUB NONE NONE NONE 1
0178136 11/21/2001 MO 5.0 5 M 11/14/2001 Pt developed a large local reaction with induration, erythema and fever. Y U 11/13/2001 11/14/2001 1 PVT PVT NONE NONE 1
0178137 11/21/2001 IL 48.0 48 F 11/12/2001 Pt complained of tenderness left neck base and tenderness chest wall lateral to left breast. No visible palpable changes at the injection site. Pt treated with Darvocet. Y Y 11/08/2001 11/09/2001 1 OTH PVT NONE 1
0178138 11/21/2001 TX 4.0 4 M 11/15/2001 Itching and swelling at vaccine site 1 day after, resolved 1 day later. Y 11/06/2001 11/06/2001 0 NONE PVT PVT NONE Asthma 1
0178139 11/21/2001 MI 72.0 72 F 11/11/2001 Checked out redness swelling of arm down to elbow started 11/13/2001, only used cold packs. Y 11/12/2001 11/13/2001 1 PVT PVT Lasix activase, norvasc, synthroid, enalapril HTW hypot 1
0178140 11/21/2001 FL 63.0 62 M 11/02/2001 Subsequent to receiving vax, the pts right upper arm red from shoulder to elbow with no pain or swelling. The next day the redness subsided in the upper arm and went to lower arm with evidence of water under the skin (not blisters).Subsequently the pt recovered. Y Y 10/30/2001 10/30/2001 0 NONE PUB PUB NONE NONE NONE 1
0178141 11/21/2001 CA F 10/24/2001 Aching increased in left arm, encompassing entire arm, axilla times 2 day gradually diminished over 1 week. Y 10/15/2001 10/15/2001 0 PUB PVT NKDA 1
0178142 11/21/2001 NC 80.0 80 F 11/20/2001 A physician reported that a female in her late 80's received an injection of Flu Shield ('01-'02). On 11/12/01, approx. 5 to 7 days post vax, she developed a severe, blistering, maculopapular rash on the front and back of her trunk. She was treated with valacyclovir and steroids. On 11/18/01, she died. No further information was available at the date of this report. Death certificate states cause of death as vasculitis with other significant condition of stroke. Y 11/18/2001 Y N 11/07/2001 11/12/2001 5 UNK PVT OTH Zoloft UNK Aphasia; Cardiovascular disorder NOS; Cerebrovascular accident NOS HQ8617920NOV2001 1
0178143 11/21/2001 MN 0.5 0 .5 F 11/15/2001 Fever started 11/12/2001 evening. On 11/14/2001 cried throughout nite/sleepless nite. Thigh swelling, redness left. loss of appetite 11/12/2001 through 11/14/2001. Y Y 11/12/2001 11/12/2001 0 PVT PVT 1
0178144 11/21/2001 CT 37.0 37 M 11/14/2001 Pt experienced vomiting, diarrhea, muscle and joint pain and weakness. U 11/13/2001 11/13/2001 0 NONE PUB PVT NONE NONE NONE 1
0178145 11/21/2001 NC 31.0 31 F 11/14/2001 One day post vax the pt developed 3 liquid filled blisters approximately the size of pencil erasers. The next week the pt developed acute bronchitis with flu-like symptoms. Was seen by physician. Y Y 10/23/2001 10/24/2001 1 NONE OTH PVT NONE NONE 1
0178146 11/21/2001 NC 27.0 27 F 11/14/2001 Two inch diameter big, red area on arm appeared 2 days after shot, felt lethargic, headache, stomach ache. Saw doctor that day on 10/24/2001. 10/22/2001 10/24/2001 2 NONE OTH PVT NONE NONE 1
0178147 11/21/2001 NC 1.0 1 .0 F 11/14/2001 Pt seen on 11/2/01 with an 8 day history of rash and 6 day history of URI symptoms. On exam, her rash was consistent with erythema multiforme. Pt also noted to have right otitis media. Follow-up exam on 11/6/01 showed possible mucous membrane involvement, questionable erythema multiforme minor. Follow-up exam on 11/14/01 showed no new erythema multiforme lesions but new fever and bilateral otitis media. It is unknown if erythema multiforme time course was consistent with vax as cause. Pt also had infection as possible etiology. Y Y 09/28/2001 10/25/2001 27 NONE PUB OTH Aventis IPV, lot #T0909, SQ, 2 previous doses, given 9/28/01; Lederle Hibtiter, lot #477390, IM RL, 2 previous doses, given 9/28/01 UNK NONE 1
0178149 11/21/2001 CA 95.0 95 F 11/21/2001 Pt had been to PCP on 11/8/01 for a check-up and she was healthy, no medical problems and blood work was normal. She was found on 11/13/01 per housekeeper on the floor. MD signed the death certificate as "atrial fib" but said COD was either heart attach or CVA. No autopsy done. Actual death certificate states cause of death as ventricular fibrillation due to coronary artery disease. Y 11/12/2001 N 11/10/2001 11/12/2001 2 OTH PUB NONE NONE NONE 1
0178724 11/23/2001 OH 77.0 77 M 11/23/2001 Pt developed Temperature 102, "shook from head to toe". Pt felt was either from flu shot or related to previous heart condition. ER doctor felt pt had a virus and put on antibiotics. Pt recovered. Y Y 11/01/2001 11/01/2001 0 EKG and CXR - OK in. ER 11/01/01 PUB PVT NONE Previous heart attack OH0067 1
0178151 11/26/2001 OH 53.0 53 M 11/15/2001 It was reported that a 53 year old male pt received a Fluzone SV '01-'02 vaccination, lot U0S682AA, on 10/25/01. One week later, the pt experienced tingling of his fingers and legs, leg weakness and is currently being treated in the hospital by a physician. Y U 10/25/2001 11/01/2001 7 OTH OTH U2001011460 1
0178158 11/26/2001 NY 38.0 38 M 11/02/2001 About 1 1/2 days, post vax, I suffered a seizure. Y U 10/05/2001 10/06/2001 1 All tests (EDG, EEG, Cat Scan) were normal. OTH OTH NONE NONE 1
0178163 11/26/2001 MD 1.0 1 .0 F 11/15/2001 Pt developed a high fever of 104F on 11/07/01. She was lethargic on 11/10/01 with a rash and lethargic on11/11/01 with tremors. Y Y 2 Y 11/02/2001 11/07/2001 5 CBC; Blood culture; CSF culture, PCR, HIV and enteromonas) PVT PUB NONE NONE NONE 1
0178164 11/26/2001 MO 1.0 0 .5 F 11/15/2001 3 doses of Prevnar given. Pt developed clinical pneumonia about 6/22/01. (Vaccine failure). Inpatient overnight and prolonged po ATB caused thrombocytopenia (9/01-10/01). Platelet count less than 10K and transfused X 1; Rx-PCN; cefotaxime. This physician states that he does not intend to report the ITP as a UEX AE. He believes it is related to the infection. No serotype of the pneumococcus. Y Y Y 1 Y 02/19/2001 06/22/2001 123 BAL performed for persistence. Culture from BAL w/3+ growth strep pneumonia. PVT PVT Multiple antibiotics; MDI's; Bronchodilators Clinical bilateral pneumonia NONE 1
0178165 11/26/2001 FL 4.0 4 M My son was a normal kid from birth to 4 years old when he had a seizure and brain strokes. Post vax, he slept about 3 hours and when he awoke he was staring at the TV which was turned off. His eyes rolled over, he threw himself backwards and started to shake. I placed him on the floor and he started to clench his teeth, still shaking and foam was coming out of his mouth. At this point, his tongue was purple and he started to get pale and cold. I called 911 and they took him to the hospital. He was found to have an ear infection. We went home on 11/26/01. He had a second seizure on 11/28/96. He has seizure activity occurring about 5 X a month. He started going to rehabilitation clinic, occupational therapy, physical therapy and a neurology clinic. He also started going to the psychiatric clinic. He had to go to a special school class to learn all he had lost. On 11/25/96, I called 911 and they come and took him to the hospital. At 4 1/2 years of age, the pt has frequent tantrums, kicks, pushes, bites, throws objects around. He has poor listening skills, retention and comprehension, short attention span and unable to sit for a while (high energy level). He has a severe speech problem. His right hand was effected by a mild stoke due to vaccination while suffering from an ear infection. Behavior deteriorating both at home and at school. He has developmental delay of speech and motor. Started Ritalin and hold off on anti-epileptic drugs and return to clinic in a month. Start occupational therapy, physical therapy and speech therapy. On 12/12/97, increase Ritalin on a trial. Seizures preceded by occipital pain. Pt was started on Tegretol in 3/97. He also now wets the bed. Y Y Y 1 Y Y U 11/25/1996 11/25/1996 0 1st MRI-cloudiness but 2nd MRI-nml; EEG-nml; PUB PVT PPD test Mother had a seizure during delivery. Mother is in a special school. Pt has asthma and is on albuterol. 1
0178166 11/26/2001 KY 0.3 0 .4 F 10/18/2001 This information on previous events was received on 10/15/01 upon receipt of order by MD to continue immunizations. Child was hospitalized 3 or 4 days, post vax, Mother said the child was in the hospital for 2 days and then transferred to another hospital for 2 days due to seizure activity and test resulting from seizures. She was started on Dilantin and Phenobarbital after 2/01 episode. She had another seizure after DTAP and Prevnar on 4/12/01. At this event, Phenobarbital and Dilantin had already been stopped. She has had other seizure activity at times other than post vax. Pt had vaccines on 10/18/01 upon receipt of approval from PMD. On 11/19/01 to date, the mother has not reported adverse event, if any, that was after injections given on 10/18/01. Y Y 2 Y 02/05/2001 02/08/2001 3 PVT PUB KY2001085 1
0178167 11/26/2001 TX 31.0 31 F Large nodule Y 11/07/2001 PVT OTH Asthma, Allergic rhinitis 1
0178168 11/26/2001 TX 67.0 67 M Pt had goose eggs bump and sore nodule. U 11/12/2001 PVT OTH Acute bronchitis 1
0178169 11/26/2001 AK 41.0 41 F 11/01/2001 Pt had soreness in injection site on 10/20/01, which resolved. On 10/20/01 she had an episode of nausea, severe diarrhea, right eye felt like it was paralyzed and reports it was swollen, and her heart rate was rapid and light. Approximately 1 hour after the episode of diarrhea, she reported feeling better and the swelling in her eye went away. She did not have any further episodes. Y 10/19/2001 10/20/2001 1 PUB PUB Allergy to metronidazole AK200168 1
0178170 11/26/2001 UT 48.0 48 F 10/31/2001 Woke up at midnight with severe chills. Took warm bath and noticed entire right arm ached and right hand joints swollen. Began vomiting X 20. At 2:00 AM temp was 101 F. and right neck gland was swollen, right ear ached , and right eye lid was swollen. Chest felt heavy and shooting pains from right side across chest, 3:30 stomach settled . At 6:00 AM all symptoms still present but very diminished. 11:00 AM some residual knuckle swelling, other signs and symptoms gone. No difficulty breathing. Slight tenderness at injection site at injection site on right deltoid. Called hospital at 3:00 AM-told it was flu shot. Y 10/30/2001 10/31/2001 1 NONE PUB PVT inhalers, levaquin bladder infection Asthma UT010621 1
0178171 11/26/2001 UT 51.0 51 F 10/29/2001 From nursing notes in chart per K. Ellis-benign. FWP-C 10/25/2001 had yellow fever vaccine 24 hours ago; has 1 ? at sit of immunization. 3 cm x 2 cm solid red lesion in right upper SQ area. Area is warm to touch . Pt denies any egg, latex, gelatin and sorbital allergy. Tx with ice and antihistamine. Y 10/24/2001 10/25/2001 1 NONE PUB PVT NONE NONE NONE UT010620 1
0178172 11/26/2001 MA 44.0 44 F 11/15/2001 Sore Arm at injection site(painful) and hand swollen . Swelling at site locally, then felt ill and chills 5 hrs after vaccine admin. Y 11/14/2001 11/14/2001 0 NONE PUB PVT Flovent NONE ASthma, bursitis, had hole in heart-repaired Same~Influenza (Seasonal) (no brand name)~~0.00~In Patient 1
0178173 11/26/2001 NJ 19.0 19 F 10/25/2001 According to pt, her right arm is feeling sore. On 10/23 at 12 noon the pt complained of nausea, and temp of 100.3, diaphous?. The pt complained of 2 welts size of 5 cent piece, red and swollen and hot to touch. Right upper arm tender, pt alternate hot and cold compresses to site. PHN stressed cold compresses . Pt taking Tylenol and has appt with MD. Y N 10/22/2001 10/23/2001 1 PUB PUB Vitamins NONE Poison Ivy NJ200123 1
0178174 11/26/2001 CA 52.0 52 F 11/21/2001 Pt stated she felt hot, flushed rash and itching to arms, chest, torso, and face. Also a headache to left side of head only. No respiratory distress. Y Y 11/16/2001 11/16/2001 0 NONE PVT PVT Flonase and Allegra NONE Basic allergies and history of exercise induced asthma 1
0178175 11/26/2001 IL 60.0 60 F 11/21/2001 Pt felt sick to stomach, had a bad headache. Went to bed during this time and face at one point felt like it was on fire from the inside out. Felt bad next day. Y 10/09/2001 10/09/2001 0 OTH OTH Tenormin, Zocor, Prinivil NONE 1
0178176 11/26/2001 MA 4.0 4 F 11/22/2001 Hot, red, puffy from injection site upper arm to elbow. Localized reaction to injection site. Keflex prescribed. U 11/21/2001 11/22/2001 1 PVT PUB NONE Allergy to nuts 1
0178177 11/26/2001 MI 70.0 70 M 11/02/2001 Pt broke out with rash at 6:45. Received flu shot at clinic at 2:00 pm. I've been getting flu shots for years. Describes broke out in hives and itching relieved with Benadryl. Took at 10 AM and AM Advised to call Dr. U 11/01/2001 11/01/2001 0 PUB PVT UNK MI2001089 1
0178178 11/26/2001 PA 43.0 43 F 11/14/2001 Pt had fever night of vaccination. Pt also had malais and axilla rash. Y U 11/07/2001 11/11/2001 4 NONE PUB PVT Premarin NONE Betadin 1
0178179 11/26/2001 LA 78.0 78 F 11/13/2001 Excessive dizziness and very white (not just pale) for 3 days. Did not want food, very weak. Y 10/19/2001 10/23/2001 4 OTH OTH 1
0178180 11/26/2001 MI 75.0 75 M 11/12/2001 Acute labrynthitis with hearing loss in left ear and acute balance disturbance. Y U 10/18/2001 10/20/2001 2 Audiograms X 2 and meds . MRI done. No results recorded. PUB OTH NONE 1
0178181 11/26/2001 MO 38.0 38 F 11/13/2001 Arm went numb up into the side of my face. right side where I got shot. Dizziness, short of breath,and nausea. The next day I got sick again. I had shortness of breath and pains going up my arm and extremely weak. First day symptoms lasted around 5 hrs and 2nd day only 2 or 3 hours, till I got medicine. I was sick feeling for 5 days . i was prescribed Claritin and Vioxx. Y Y 11/01/2001 11/01/2001 0 OTH PVT Wellbutrin, Rantidine NONE Allergy to PCN 1
0178182 11/26/2001 M 11/13/2001 Injection reaction of left leg 3 cm and crying X 8 hours. Y 11/12/2001 11/13/2001 1 NONE PVT PVT NONE NONE 1
0178183 11/26/2001 MN 1.0 0 1 M 05/04/2001 Pt received multiple vaccines and developed a fine macular rash over trunk, back around 10 minutes after injections. 20 minutes later, had hives moving from face to shoulders, back, and chest. Gave Children's Benadryl and called later that day with no other problems. Hives cleared by 8 hours. Y 10/19/2001 10/19/2001 0 NONE PVT PVT NONE NONE NONE 1
0178184 11/26/2001 MI 1.4 1 .3 F 10/26/2001 Pt in for vaccines today. Mom states took child to urgent care on 8/21/01 after child received vaccines on 8/20/01 for right leg swelling in thigh. Y Y 08/20/2001 08/21/2001 1 NONE PUB PUB NONE NONE NONE MI2001087 1
0178185 11/26/2001 NJ U For the last 2 and 1/2 years I have been in constant pain that keeps moving all over my body. N OTH PUB 1
0178186 11/26/2001 NJ 40.0 40 M 11/19/2001 Pt stated he had metallic taste in mouth. Face was flushed. Y Y 11/16/2001 11/16/2001 0 PUB OTH Glucophage, Glucotrol NONE Diabetes 1
0178187 11/26/2001 OH 23.0 23 M 11/14/2001 Painful right arm at site of injection. No medical findings. Y U 10/24/2001 11/11/2001 18 X-ray was negative PUB OTH NONE Puncture wound left left leg from wire NONE 1
0178188 11/26/2001 CA 22.0 22 F 11/15/2001 Mild flu-like symptoms with subsequent rash. U 11/02/2001 11/12/2001 10 NONE PVT OTH NONE NONE NONE 1
0178189 11/26/2001 HI 0.5 0 .5 F 11/15/2001 Fever 105 (AX) from 11/14/01 around 11:50 PM to 11/15/01 6:00 PM Y 11/14/2001 11/14/2001 0 NONE PVT PVT NONE NONE NONE 1
0178190 11/26/2001 LA 1.7 1 .7 F 11/15/2001 The pt developed a right upper thigh with erythema and swelling. Y U 11/13/2001 11/13/2001 0 PVT PVT NONE NONE 1
0178191 11/26/2001 MO 62.0 62 M 11/14/2001 Unable to move arm or lift. It is very painful. No redness or swelling to the injection site. Y U 11/12/2001 11/12/2001 0 PVT PVT Emphysema; non-productive cough PCN allergy 1
0178192 11/26/2001 MA 25.0 25 M 11/10/2001 I received a Hep-B vaccine and after arriving home, I experienced and developed a rash along with right arm soreness and weakness. I treated it with Benadryl 50mg X 2-8 hours apart. Y 11/09/2001 11/09/2001 0 OTH PVT Asthma with no treatment at this time. 1
0178193 11/26/2001 NC 1.0 1 .0 F 11/13/2001 Urticaria the next day. Y U 11/08/2001 11/09/2001 1 NONE PVT PUB 1
0178195 11/26/2001 MI 2.0 2 .1 M 11/12/2001 Pt developed erythema and papulo-vesicular rash circumferential to the Hib injection site. N 10/29/2001 11/01/2001 3 PVT PUB NONE NONE NONE 1
0178196 11/26/2001 AK 18.0 18 F 11/08/2001 Spoke with pt's mom and she said that the pt received the Hep-B #3 and Hep-A #2 at 14:50. Her sister found the pt in the bathroom passed out with weak pulse at 16:30. EMS took her to the ER. Pt was discharged to home. Y U 10/18/2001 10/18/2001 0 EKG; Cat Scan; Blood work PVT OTH 1
0178197 11/26/2001 LA 67.0 67 F Developed very large local reaction upper left arm, generalized pruritis. Treated with epinephrine, Claritin, Prednisone and Motrin. Symptoms peaked at about 4 hours after injection was given. Y 11/15/2001 11/15/2001 0 NONE MIL MIL Tenormin, Maxide, iron and calcium NONE IVP dye 1
0178198 11/26/2001 MN 1.0 1 .0 F On 11/27/00, pt developed a fever and was fussy. On 11/28/00, she was dx'd with bilateral otitis media and URI. Rx'd with amoxicillin according to parent. On 11/29/00, she was seen by MD at ER with fever. On 12/01/00, the pt was seen by SLP and dx'd with Roseola. Rashes eventually resolved as did the fever. Y 11/21/2000 11/27/2000 6 Blood culture and Urine cultures were neg. Wbc-3,300; HHV-6; AbIgM-40; IgG-80; RAST Egg White PVT PVT NONE Eczema on 1/17/00 and constipation on 4/13/00 1
0178199 11/26/2001 AZ 13.0 13 F 11/08/2001 Thirty minutes post vaccine client developed a red rash "from red to toe" and stated her body felt hot "like a sunburn" and her legs "felt like they fell asleep". No difficulty breathing. In formed Mom to go directly to ER and take Benadryl PO if available. Mom did go to ER where child received Benadryl and Zantac PO. Dischrged same afternoon Fl RN called mother next day and child has fully recovered. Fl RN. Y Y 11/07/2001 11/07/2001 0 PUB PUB NONE NONE UNK AZ0125 1
0178200 11/26/2001 KS 4.0 4 M 11/19/2001 Left arm swollen and red after shot, seen when undressing for bed, went to urgent care, entire bicep swollen and red, completely resolved by 11/20/2001. Y 11/12/2001 11/13/2001 1 NONE PVT PVT Singulair Reactive Airways Sulfa, egg allergy, PCN 1
0178201 11/26/2001 NH 1.25 1 .3 F 11/15/2001 Pt developed an erythematous 3cm area localized on right arm. Y 11/13/2001 11/14/2001 1 NONE PVT PUB NONE NONE NONE NH0125 1
0178202 11/26/2001 FL 18.0 18 F 11/23/2001 One day post vax, pt had macular/papular rash all over arms and legs. U 11/20/2001 11/21/2001 1 OTH OTH NONE 1
0178203 11/26/2001 KY 0.3 0 .4 F 11/13/2001 Rash appeared on 11/7/01, and on 11/8/01, pt had rash over entire body. Y Y 11/06/2001 11/07/2001 1 NONE PUB PUB NONE NONE NONE KY2001087 1
0178204 11/26/2001 KY 5.0 5 M 11/14/2001 Pt developed itching on way home after receiving vaccine. At 10:44 PM on the night of receiving vax, pt presented to ER with hives. He was treated with Benadryl and Pediapred. He was discharged from ER at 11:15 the same night. Y Y 11/13/2001 11/13/2001 0 PUB PUB Flonase NONE NONE KY2001086 1
0178205 11/27/2001 NM 0.2 0 .2 M 09/13/2001 Baby received immunizations 09/11/2001. Was found dead less than 24 hours later. Death is being investigated as a SIDS death. Autopsy results will be reviewed by MD, Epidemiology, and shared with LHO and Immunization program. COD as per autopsy report -- SIDS Y 09/12/2001 N 09/11/2001 09/12/2001 1 PUB PUB Tylenol NONE NONE NM090101 1
0178207 11/27/2001 ME 72.0 72 M 12/26/2001 Information has been received from a health professional concerning a 72 year old male who on 11/5/01 was vaccinated with a 2nd dose of pneumococcal vaccine 23 polyvalent (lot 636159/1070K). It was reported that the pt was vaccinated with a 1st dose 5 years ago and had no history of adverse event. On 11/6/01, in the early AM, the pt experienced redness, swelling and pain from his shoulder to past his elbow. He presented to the physician's office for evaluation and it was reported that his arm was swollen, hot and red from his shoulder to past his elbow and into his hand. The pt went to the ER, was treated with prednisone and an antihistamine and was released. The pt was seen at the physician's office since his ER visit and has completely recovered. Upon internal medical review, the pt's experiences were considered "Other Important Medical Events". The reporter expressed a concern with the lot. The reporter indicated that a female pt (WAES 01112307) had a similar experience following exposure to pneumococcal vaccine 23 polyvalent. Additional information has been requested. Y Y 11/05/2001 11/06/2001 1 PVT OTH Aspirin; Atrovent; Prinivil; Serevent; Ambien COPD WAES01111206 1
0178208 11/27/2001 LA 11.0 11 M 11/21/2001 A 11 year old white male was vaccinated on 08-OCT-2001, intramuscularly, pneumococcal vaccine 23 polyvalent. Concomitant therapy included MSD, albuterol, Concerta and Zithromax. On 09-OCT-2001, the pt experienced a painful hip with development of erythema at the injection site and his asthma was bothering him. On 11-OCT-2001, the pt presented with a 8 by 11 cm raised erytemaous whelp surrounding the injection site. The area was hot to touch. The pt also presented with increased respiratory difficulty, a low grade temperature and intertitial right middle lobe and "lingular" infiltrates. The pt was placed on therapy with Keflex. The MD stated that it may have been a sterile abscess and he would have to draw and culture it. On 15-OCT-2001, the pt was improving with fading erythema, the area was the same size with a firm centered 4 by 3 cm area that was tender. Therapy with Keflex continued. On 19-OCT-2001, the pt was "feeling well". The area was 5 by 6 cm, an endurated and firm area around the injection site with minimal tenderness. A follow up phone call on 26-OCT-2001, revealed the pt had recovered from the reaction. Upon internal review, the pt's infiltrates were considered an other important medical event. Additional information has been requested. Y Y 10/08/2001 10/09/2001 1 PVT PVT albuterol, zithromax, concerta, singulair Bronchitis Asthma WAES01101831 1
0178212 11/27/2001 PA 0.3 1 .1 M 11/20/2001 Information has been received from an RN concerning a 4 year old male who on 10/8/98 was vaccinated with Varicella virus vaccine live (628027/1257H). The pt had previous vaccinations including Hep-B, Hib conjugate vaccine, diphtheria toxoid (Infanrix-IPV-Hib) and measles-mumps-rubella. MMR was given on 12/18/98. In 1998, the pt developed a rash and fever of 101F after therapy with diphtheria toxoid/tetanus toxoid, Hep-B recombinant (yeast) and diphtheria toxoid (+) haemophilus b conjugate vaccine (+) pertussis vaccine (+) poliovirus vaccine (+) tetanus toxoid vaccination (WAES 01112562). Also in 1998, the pt developed a rash after being inoculated with diphtheria toxoid (+) haemophilus b conjugate vaccine (+) pertussis vaccine (+) poliovirus vaccine (+) tetanus toxoid vaccinations and Hep-B vaccine recombinant (yeast), which lasted 12 days (WAES 01112561). The RN reported that both fever and rash were thought to be related to a probable reaction to therapy with diphtheria toxoid (+) tetanus toxoid. In 6/99, the pt developed autism with a pervasive developmental disorder. The pt is being followed by a physician at the time of this report. Upon internal review, autism was considered an "Other Medical Event". Additional information has been requested. A 15-day follow up report received 2/5/2003 adds: Information has been received from a registered nurse concerning a 4 month old male with a 'casien' allergy, eggs allergy and gluten allergy and a history of transient synovitis in March 2001, and hospitalizatin for pneumonia in April 2001. On 10/08/1998 the pt was vaccinated with varicella virus vaccine live (lot #628027/1257H). Concomitant therapy included cotirixine hydrochloride (Zyrtec) prn. It was also reported that on 10/08/1997 the pt was vaccinated with Hepatitis B vaccine recombinant (yease) (MSD) (lot #624497/0923E) and on 11/07/1997 with HIB conjugate vaccine (MSD)(lot #624924/lll2E), alum. potassium (+) diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid (Tripedia), and poliovirus vaccine inactivated (IPOL). Subsequent to the vaccinations on 01/13/1998 the mother reported that the pt developed a rash and fever (101 F) (WAES #01112562). On 03/13/1998 the pt received a second dose of therapy with alum. potassium (+) diphtheria toxoid (-) pertussis vaccine (+) tetanus toxoid (Tripedia) and Hepatitis B vaccnie recombinant (yeast) (MSD) (lot #625399/1447E). Subsequent to the vaccinations on 03/13/1998 the pt developed a rash, 12 days duration (WAES #01112561). The registered nurse reported that both fever and rash were thought to be related to a probable reaction to therapy with alum. postassium (+) diphtheria toxoid (-) pertussis vaccine (+) tetanus toxoid. It was also reported that on 12/18/1998 the pt was vaccinated with measles virus vaccine live (-) mumps virus vaccine live (-) rubella virus vaccine live (second generation) (MSD) (lot #628905/1362H). In June 1999, the pt was diagnosed with pervasive developmental distorder, autism. The pt was being followed by a physician at the time of this report. Upon internal review autism was considered an other medical event. This is an amended report. The lot numbers have been corrected in the narrative. The pt's age now reads '4 month old' instead of '4 year old'. The concomitant therapy "diphtheria toxoid (+) Haemophilus B conjugate vaccine (+) pertussis vaccine (+) poliovirus vaccine (+) tetanus toxoid Infanrix-IPV-HIB' has been changed to 'alum. potassium (+) diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid (Tripedia) and poliovirus vaccine inactivated (IPOL).' The coding of 'drug reaction' has been removed as an adverse event. the pt's recovery status was changed to 'not recovered' to reflect the diagnosis of autism. Additional information has been requested. This report is corrected as amended. Y N 10/08/1998 01/13/1999 97 Temperature-101F OTH OTH Zyrtec Hospitalization; Pneumonia; Synovitis; Allergy; Eggs allergy WAES01110497 1
0178217 11/27/2001 NV M 11/20/2001 Information has been received from a male physician who in approximately August 2001 was vaccinated with one dose of Hepatitis B. The physician reported that he was notified that his EMG indicated that he almost certainly had chronic idiopathic or(innumologic-auto immune) demyelinating polyradculneuropathy (CIDP). The physician noted the he will need blood and spinal fluid tests. His EMG indicated little axonol damage and lots of demyelination. He felt it may be early in its course. A repeat test was interpreted the same way by two neurologists. The physician's wife WAES01092572 also received hepatitis b vaccine and developed bilateral optic nerve swelling, calf tenderness, frontoparietal headache, transient visual loss in right eye, sensory fifth left nerve loss and lightheadness. The physician indicated that it is extremely improbable that anything other than the hepatitis b was the inciting factor for both he and his wife. Both had been extremely healthy and infection free. Upon internal review, chronic idiopathic demyelinating polyradiculoneuropathy was determined to be an other important medical event. No further information is available. Y N 08/01/2001 EMG done in 10/01 results showed little axonal damage and lots of demyelination OTH OTH UNK UNK WAES01111379 1
0178218 11/27/2001 TX 0.2 0 .2 F 03/14/2001 Seizures, twitching eyes, drooling, smacking lips, trembling, blue around lips and eyes, eyes rolled back and jerking limbs. Had 4 seizures on 12/26/00 and was hospitalized for 7 days. Seizures followed on 1/2/01 through 1/5/01 and was hospitalized for 5 days. Seizures followed again in late February. Y Y 12 Y U 12/22/2000 12/26/2000 4 Lumbar Puncture; MRI X 2; EEG X 2; random lab work PVT PVT 1
0178219 11/27/2001 PA 50.0 50 F 12/27/2002 Severe leg strain, muscles tight, muscle weakness. Progressive and worsening. Onset 48 hours, post vax, to present. Leg stiffness, feeling of sprained tendons and ligaments, muscle tightness, muscles in legs hardened and visible. Fevers to 101F and lymph nodes. Follow up report states " Took 4 years for patient to recover. Apathy among physicians,staff & hospital. Pt now experiences stumbling spells that probably are not related but will be examined." Y Y Y 10/08/1998 10/10/1998 2 Venous/arterial doppler study; bone scan; x-rays of spine; EMG; Extensive blood panels-nml; MRI; Neurologist; Rheumatologist and Orthopedics PVT OTH Inderal, Augmentin; Lanoxin; Diozide; Hytrin Cancer survivor-breast; Allergy to fish and shellfish, ephedrine; Hypertension; PAT 1
0178220 11/27/2001 NC 1.08 1 .1 F 11/10/2001 Pt presented on 11/10/01 with a 2-3 day history of irritability, tactile temperature, vomiting, poor appetite, decreased urine output, active but weak and sleeping poorly. Rash began 2 days prior: pink and red coloring, macular on face and chest. It clears centrally. Palms and soles are clear but some lesions when pressed changed to pinpoint petechiae morbilliform. Child is listless and ill appearing. No lymphadenopathy. Eye injected + runny nose and unusual cough. Also diagnosed with hypovolemia. Y Y 10/17/2001 11/08/2001 22 PVT PUB NONE NONE NC01100 1
0178221 11/27/2001 AZ 1.0 1 .1 M 11/20/2001 Chicken pox and MMR vaccine received and had decreased platelet count, 6 weeks later (ITP). Was hospitalized and received Winrho, prednisone. Y 1 U 05/08/2001 05/14/2001 6 Platelet count-6,000 initially and on 10/01 it was 38,000 PVT PVT NONE NONE 1
0178222 11/27/2001 AZ 60.0 60 F Pt developed angioedema with rash and swelling less than 24 hours, post vax. Y 1 Y 11/19/2001 11/20/2001 1 PVT PVT Prinivil; Glucophage; Lipitor; ASA; glyburide; Lopid NONE DM; HTN; Hypertriglyceridemia 1
0178223 11/27/2001 MD 42.0 42 F 11/06/2001 Pt rec'd flu shot in am, proceeded to downstairs main lobby where she said she started to feel "lightheaded & clammy". Pt laid down on a sofa & felt better; proceeded to stand up & "passed out". Pt denies respiratory or cardiac distress at the time of currently. States she gets worked up over getting shots & she feels that is what precipitated her "adverse rx". Pt's pulse 88 & regular, respiration 18/regular & unlabored; nails & tips pink, skin warm & dry, denies need for further medical management. Y 11/05/2001 11/05/2001 0 NONE OTH OTH 1
0178224 11/27/2001 WA 9.0 9 M 11/16/2001 L shoulder - most superior aspect, aspect with 2cm black & blue bruise. Completely inferior but centrifuge is a 12x12cm area of redness, mild induration, mild warmth, but no significant tenderness. In future consider benadryl with flu vaccine. Y 11/13/2001 11/15/2001 2 NONE PVT PVT NONE NONE NONE 1
0178225 11/27/2001 PA 4.0 4 F 11/15/2001 Left arm redness, warmth, swelling, localized, and fever. Drugs: Benadryl, Keflex. U 11/13/2001 11/14/2001 1 PVT PVT NONE NONE NONE 1
0178226 11/27/2001 WI 75.0 75 F 11/14/2001 Next day, pt (volunteer), states she developed redness, swelling, itching, extending to elbow. Took 1 week to resolve. Did not come in to let us observe, but told us after the fact. no medical care sought. Y 10/14/2001 10/18/2001 4 NONE OTH OTH NONE UNK no allergies to eggs 1
0178227 11/27/2001 WI 48.0 48 F 11/14/2001 Developed baseball sized red area, hot and tender with irregular borders slightly elevated at injection site medical diagnosed as cellulitis and was put on Keflex. Y 10/17/2001 10/18/2001 1 OTH UNK NONE No allergies to eggs. 1
0178228 11/27/2001 TX 6.0 6 F Developed severe, widespread urticaria and angioedema of her face and hands. This started approximately 20 hours after receiving the vaccine (and starting zithromax) and lasted about 3 days. Y 10/26/2001 10/26/2001 0 PVT PVT Mycoplasma Asthma 1
0178229 11/27/2001 TN 65.0 65 F 11/13/2001 Pt taking ibuprophen every 4 hrs around the clock since 11/9, fever;chills 11/11 - area hot to touch, red painful 7"x3 1/2" area of swelling - tender enlarged lymph nodes - give amoxicillan 500mg tid x 7 days. Y U 11/09/2001 11/09/2001 0 PUB OTH NO NO TN01056 1
0178230 11/27/2001 OH 40.0 F 11/03/2001 Pt rec'd flu vaccine on 11/1/01 and notified Sauna on 11/2/01. On L deltoid she developed 3" circular red raised area which was sore. She stated she had the same reaction to flu shot last year. She did not seek Medical attention. Y 11/01/2001 11/02/2001 1 NONE PUB PVT NONE same reaction to flu shot 1 year ago - got shot at another site. red raised area, sore~Influenza (Seasonal) (no brand name)~1~39.00~In Patient OH0064 1
0178231 11/27/2001 TX 10.0 10 M 11/15/2001 1 day after rec'd flu vaccine (and 5 d after starting Pen VK for strep pharyngitis) he developed urticaria and angioedema (face & feet), lasting 7 days (hives) (angioedema x 3 d). (I have referred for testing for Pen allergy) Y 10/26/2001 10/27/2001 1 OTH OTH Strep throat Asthma 1
0178232 11/27/2001 GA 23.0 23 F 10/31/2001 Local reaction L deltoid. Red with itching. Ice to area and 2 tsp Benadryl given po. Y 10/31/2001 10/31/2001 0 OTH OTH NONE 1
0178233 11/27/2001 OH 67.0 67 F 10/24/2001 Beginning 6:30pm noticed extreme soreness on 10/22/01 R deltoid and progressed over the night to soreness and erythema & edema R upper arm from deltoid to elbow. Pain and above sx's continue as of 10:20 on 10/24/2001. Took 3 advil at 9am 10/24/2001. N 10/22/2001 10/22/2001 0 NONE PUB PUB Synthroid x3 yrs NONE NONE OH0061 1
0178234 11/27/2001 NY 22.0 22 F 11/23/2001 11/20/01 - AM nausea, vomiting, temp 100F, chills. 11/21/01 started to feel better. no vomiting, no temp, ate small amounts. No reaction at site of injection Y 11/19/2001 11/20/2001 1 NONE OTH OTH NONE NO 1
0178235 11/27/2001 NY 29.0 29 F 11/23/2001 11/20/2001 Vaccine 3 PM. 11/21/2001 Felt ill, warm temp 102, nausea. Went home early from work, vomiting. 11/22/2001 Temp 99.9, nausea continues, no vomiting. 11/23/2001 arm numb. N 11/20/2001 11/21/2001 1 NONE UNK UNK Mantoux Lot CO834AB Interdermal NONE Latex allergy 1
0178236 11/27/2001 CA 26.0 26 F 11/02/2001 Flu vaccine administered 10/31/2001 8-10am. Pt c/o nausea, vomiting, visual disturbances, lightheaded, diarrhea. Vaccine reaction, Tx phenergan, tylenol. Referral to PDH ER and released. Y Y 10/31/2001 10/31/2001 0 NONE PUB PVT NONE NKA 1
0178237 11/27/2001 MO 51.0 51 F 11/01/2001 Client reports severe tenderness, warmth, and redness "beyond 4 hrs after receiving injection - currently has 12cm x 4cm area of induration "redness, warmth (3 days after injection) - has not used Tylenol, ibuprofen, benadryl , etc - no treatment, applied ice to R upper arm. Y 10/29/2001 11/01/2001 3 PUB PUB NONE NONE Iodine, codeine, morquitor, NIDDM MO2001059 1
0178238 11/27/2001 ID 41.0 40 F 11/14/2001 SOB an felt funny after flu shot. C/O feeling cold, stridor wheezing R 24/mm, sinus tachycardia, numbness & tingling in fingers. Pulse 100-120, BP 140/90 to 165/90. Pt treated with epinephrine, benadryl, o2. Y Y 11/14/2001 11/14/2001 0 EKG/sinus tachycardia PVT PVT 1
0178239 11/27/2001 OR 41 F 11/20/2001 Pt had fever of 101F; pain & swelling 6x4cm over site R deltoid when flu & Pneumovax given at same time and location. Y U 11/08/2001 11/10/2001 2 CBC: wbc 17.6 with left shift. OTH OTH Paxil, Claritin, lorigl, BCC delayed hypersensitivity reaction Codeine, contact dermatitis 8/01 1
0178240 11/27/2001 CA 0.4 0 .4 F 09/24/2001 Pt had onset of diarrhea on 9/22/01, PM and has continued until clinic visit in the AM of 9/24/01. She vomited X 1 in the AM of 9/24/01 without fever or other symptoms. U 09/21/2001 09/22/2001 1 PUB PUB NONE NONE Pneumonia in 6/01; URI in 7/01 CA010128 1
0178241 11/27/2001 TX 7.0 7 M 11/14/2001 The child developed a fever of 103F and a red, hot and swollen right arm, approx. 48 hours, post vax. One episode of vomiting and fever continued for 3 days. MD evaluated and stated all "tests were normal". It subsided and he is back to normal. Y Y 11/05/2001 11/07/2001 2 "all tests were normal" PVT PUB Nexium; hydroxychloroquine; Trental; Vioxx; baby aspirin NONE Mixed connective tissue disease/on Methotrexate and Prednisone TX01174 1
0178242 11/27/2001 WA 1.5 1 .5 F 11/19/2001 Approx. 4 hours, post vax, the pt had developed swelling in her left leg, about 3" in diameter, near the left anterior and lateral thigh. She also developed a circular rash near the injection sites. On 11/10/01, the rash on the pt's left leg had spread from the thigh to below the knee. No other symptoms were observed. The pt's mother did not notify the health dept until 11/16/01. Pt follow-up was with her PCP on 11/16/01. Y 11/09/2001 11/09/2001 0 PUB PUB NONE NONE NONE 1
0178243 11/27/2001 WV 1.0 0 1 F 11/20/2001 The child broke out with chickenpox. Y 11/05/2001 11/19/2001 14 PVT PVT NONE NONE 1
0178244 11/27/2001 IL 1.25 1 .2 M 11/17/2001 Rec'd vaccination on 11/15/01 (Prevnar, Trihibit, and MMR - on 11/16/2001 penny size area of redness at injection site. Today golf ball size area and warm to touch. Seen in office 11/17/01 placed on Augmentin. Y U 11/15/2001 11/16/2001 1 N/A PVT PVT NONE NONE NONE 1
0178245 11/27/2001 CA 0.5 0 .5 F Possible febrile seizure. Seen and evaluated at UCDMC, please note pt was not seen by doctor at time of vaccination. Y Y 11/05/2001 11/06/2001 1 PUB PUB CA010131 1
0178246 11/27/2001 CA 4.0 4 M 09/21/2001 According to pt's mom child developed a few rash on body & face, 1/2 hr after receiving immunization which progress to covering entire body. Pt seen the following day 9/21/01, 12:30pm given epinephrine injection and benadryl. Y 09/20/2001 09/20/2001 0 NONE PVT PUB UNK CA010127 1
0178247 11/27/2001 CA 1.0 1 .3 M 10/27/2001 October 20, 2001 pt came in with Rash throughout body. Pt received vaccines 10/19 at 11:55. Began with fever around 6 pm (then 103.0 axillary), and 1/2 hour later began to have diffuse urticarial rash that persisted till 10/20 when pt seen in clinic. Temperature 101.6 10/20, given Benadryl and Prednisone with improved. Y Y 10/19/2001 10/19/2001 0 PVT PVT NONE CA010126 1
0178248 11/27/2001 NC 1.0 1 .0 M 11/10/2001 Fever, irritability. Some rhinorrhea and cough pink morbilliform rash on chest and back. Day 3 fades to pinpoint Petechiae. Also has Bilateral Otitis Media. U 10/25/2001 11/08/2001 14 PVT PUB PPD(Tine Test) NC01099 1
0178249 11/27/2001 FL 5.0 5 M 11/19/2001 Rash on chest, back abdomen Y 11/08/2001 11/09/2001 1 PVT PVT NONE NONE NONE 1
0178250 11/27/2001 NM 3.0 3 M 08/21/2001 Febrile seizure x 15 sec - complete recovery . no hosp. Y Y 07/31/2001 08/01/2001 1 strep test + At time of seizure PVT OTH + strep pharyngitis History of febrile seizure NM080103 1
0178251 11/27/2001 NY 0.2 0 .2 M 11/18/2001 Pt held breath, slight dusty color to lips noted in 25 sec duration, central pallor noted causes nurse to give vigorous stimulation until patients color returned, I arrived, repeated stimulation which resulted in strong vigorous crying. Event resolved within 1 minutes. Y 11/17/2001 11/17/2001 0 PVT PVT Pre Maturity - 34 weeks 1
0178252 11/27/2001 NY 4.9 4 F 11/19/2001 Rec'd Prevnar (pneumococcal 7-valent conjugate vaccine) on 11/13/01, presented to medical room on 11/15/01 with redness (3.25-3.75") and slight swelling and itching. Child denies pain at site. Rash allergic reaction to ?. Y 11/13/2001 11/15/2001 2 OTH PUB NONE NONE 1
0178253 11/27/2001 FL 1.25 1 .3 M 11/19/2001 Fever. After fever broke rash broke out Y 11/15/2001 11/16/2001 1 NONE PVT PVT NONE NONE 1
0178254 11/27/2001 CA 1.0 1 .0 M 11/15/2001 Varicella like lesions scattered less than S total. Y 11/02/2001 11/14/2001 12 NONE PVT OTH NONE NONE 1
0178255 11/27/2001 WI 41.0 41 F 11/16/2001 Approximately 4 hours within injection, Pt developed redness and lump at site approximately 2-3 cm in diameter. Y 11/14/2001 11/14/2001 0 PVT PVT Premarin 0.625 mg Sulfa 1
0178256 11/27/2001 PA 78 M 11/16/2001 Soft tissue erythema/edema and arm pain U 11/13/2001 11/14/2001 1 UNK UNK No change Diabetes, colon cancer 1
0178257 11/27/2001 PA 1.08 1 .0 F 11/19/2001 Localized single vesicle on injection site. Y 11/01/2001 11/16/2001 15 PVT PUB NONE Allergy to Amoxil/Omnicef diagnosed 11/13/2001 1
0178258 11/27/2001 AZ 1.0 1 .0 F 11/15/2001 Broke out with chicken pox lesions 5 + 2 weeks after Varivax #1. Y 10/29/2001 11/12/2001 14 PVT PUB NONE NONE Well child exam 1
0178259 11/27/2001 OH 0.6 0 .9 F 11/01/2001 Symptoms started 9 hours after vaccine given. She had slight fever of 99-100, wheezing, hoarseness, trouble breathing as if she had a lot of mucus and her heart was racing. He stated the symptoms had lasted all night until 5 or 6 PM the following day. Difficulty breathing lasted until bedtime. they gave her infant Tylenol for 4-6 hors through the night. Father reported a few minutes after above report that child has wakened from nap with wheezing. Instructed to go to ER. U 10/30/2001 10/30/2001 0 NONE PUB OTH NONE NONE Allergic to cow's milk OH0062 1
0178260 11/27/2001 OH 4.0 4 M 10/19/2001 Following DTaP #5, MMR #2, IPV #4, L deltoid area became swollen, indurated, purplish by 24 hrs. 2 wks after shot, L ankle became raised,indurated, purplish & itchy. Then 2 wks after that R ankle became raised, indurated, purplish & itchy. Area around deltoid area - symptoms decreased, but discoloration still present ankles remain swollen, raised, itchy and indurated. Benadryl cream being used - but not working well, according to mom. Y U 09/26/2001 09/27/2001 1 NONE PUB OTH NO swollen & discolored at site~DTaP (Infanrix)~~1.75~In Patient OH0063 1
0178261 11/27/2001 OH 59.0 59 F 10/30/2001 Pt developed pain at approximately 4 PM that started at left deltoid injection site and travelled into left shoulder and into left side of neck to just below left ear. On 10/23/01, pt developed fever and chills. She took one dose of Tylenol. She experienced chills for 2 days. On 10/29/01, the pain in shoulder began to subside but is a little more noticeable again on 10/30/01. U 10/22/2001 10/22/2001 0 NONE OTH PUB Synthroid NONE Hypothyroid OH0059 1
0178263 11/27/2001 PA 7.0 2 .0 F 11/19/2001 early varicella break thru. benadryl po, symptomatic. U 04/25/1996 11/18/2001 2033 NONE PVT PVT NONE URI NONE 1
0178264 11/27/2001 PA 28.0 28 M 11/15/2001 Redness, swelling, warmth, given Keflex and Medrol dose pack Y 11/13/2001 11/13/2001 0 PUB OTH OTC allergies meds, (hay fever) Mantoax/Aventis/01261P/R arm/11-13-01. none NONE 1
0178265 11/27/2001 AL 1.0 1 .0 F 11/15/2001 4 hours, post vax, pt began with facial swelling and flushed, fever and generalized. Y Y 11/13/2001 11/13/2001 0 PVT PUB NONE NONE NONE AL0114 1
0178266 11/27/2001 MI 1.25 1 .3 M 11/19/2001 Cellulitis on 11/14/01. Right leg became red, swollen and warm to the touch. Y Y 11/13/2001 11/14/2001 1 PVT PVT Zantac; Amoxil NONE GERD 1
0178267 11/27/2001 PA 0 1 F 11/20/2001 Pt with varicella after vaccine. Y Y 01/13/2000 11/15/2001 672 PVT OTH head cold, cough NONE 1
0178268 11/27/2001 MI 1.0 1 .1 F 10/05/2001 Child awake in the am on 09/15/01 with am intense red rash on abdominal, face, arm and legs. No other symptoms of illness. Just rash, Mom stated child has had heat rash before but this is different from what she has seen. Mom was required to take child to doctor or 09/17/01. 11/20/01 mom reached, said rash went away 1 day later. Doctor agreed it was vaccine related. Y Y 09/05/2001 09/15/2001 10 Went to Doctor to rule out cause of rash to be none serious. PUB PVT NONE NONE NONE 1
0178269 11/27/2001 IL 70.0 70 F 11/10/2001 given pneumo shot R deltoid. Given 11/6/01. started hurting that evening, Red and swollen on 11/7/01. Y 11/06/2001 11/06/2001 0 OTH PVT NONE Seasonal, PCN 1
0178270 11/27/2001 PA 1 .0 M 11/21/2001 Varicella after receiving Varivax U 05/22/2001 11/18/2001 180 PVT PUB NONE NONE NONE 1
0178271 11/27/2001 TX 73.0 73 F 11/08/2001 11/8 entire upper arm from shoulder to elbow became red and hot, swollen. Lasted greater than 12 hrs. Y 11/07/2001 11/07/2001 0 PVT PVT Mevacor, Ocuvite NONE GERD 1
0178272 11/27/2001 NM 83.0 83 F 09/13/2001 Local erythema to L upper arm mostly inner arm onset upon awakening AM after rec'd Pneumovax L deltoid. R ankle tender to Bilateral malleoli and R achilles. Treatment Ibuprofen, tylenol PRN & recheck in 24 Hrs. Y 09/07/2001 09/08/2001 1 NONE PVT PVT thyroid med NONE HTN, Carotid stenosis, hypothyroidism NM090102 1
0178273 11/27/2001 NM 79.0 79 M 10/10/2001 Twelve hours after administered arm became swollen, red and painful. Lasted one week severe the progressively improved over another week. Y 10/02/2001 10/02/2001 0 NONE PVT PVT Tambien, Metraprolol, Aciphex, ASA, Tylenol and Tums NONE Afibrillation NM100101 1
0178274 11/27/2001 NM 4.0 4 M 10/15/2001 Swelling from hip to above knee, 2 times size of normal leg; red and tough; painful and itchy; hot to touch. Y Y 10/01/2001 10/03/2001 2 PVT UNK NONE NM100102 1
0178275 11/27/2001 NM 74.0 74 F 07/10/2001 On 07/05/2001 pt presents with about 10 cm area of redness and warmth around site of Pneumovax injection received 07/03/2001. pt reports symptoms started within 24 hours of injection. She reports applying ice packs to the site and taking ibuprofen for discomfort. Y 07/03/2001 07/04/2001 1 PVT PVT Premarin, cyclobenzaprine, Vioxx, verapamil, Darvocetn, banitadine, Serevent NONE HTN, GERD, PAT, Chronic low back pain NM010101 1
0178276 11/27/2001 NM 5.0 5 F 07/11/2001 On 07/09/2001 DTaP, IPV, MMR and 2nd Hep B given. At noon 07/09/2001 client developed low grade fever followed by vomiting and diarrhea. Fever subsided after 1 dose of Tylenol. On 07/11/2001, mother called with the above information. Instructed to go to urgent care. Y Y 07/09/2001 07/09/2001 0 NONE PUB PUB NONE NONE NONE ~DTaP (no brand name)~5~5.00~In Sibling NM070102 1
0178277 11/27/2001 NM 0.08 0 .1 M 08/08/2001 The baby had a change in behavior, crying a lot for 1 week following vaccination. A hard lump developed at injection site and still exists 2 weeks later. Fever of 102 for 2 days after shot. Y 08/01/2001 08/01/2001 0 NONE PVT PUB NONE NONE NONE NM080101 1
0178278 11/27/2001 NM U Pt received Varicella vaccine 04/20/2001, then 07/2001 had Varicella and spread to uncle. Y 04/20/2001 07/01/2001 72 PVT PUB NONE NONE NONE NM080102 1
0178279 11/27/2001 MI 15.0 15 M 11/15/2001 On 09/25/2001 shot given. No feelings of being "not well". Two days following vaccine noticed 3-4 cm lump beneath left ear; glandular area. Non-tender to touch. No fever noted. Remains swollen at this time. to check in with Clinic for evaluation. Y 09/25/2001 09/27/2001 2 PUB PUB NONE Denies NONE 1
0178280 11/27/2001 LA 42 F 11/15/2001 Pneumovax 23 given in left deltoid on 11/13/2001. Left arm, chest, and back extremely swollen, red, hot to touch, exquisitely painful. Fever of 104. U 11/13/2001 UNK UNK Synthroid Hypothyroid, allergic to codeine 1
0178281 11/27/2001 FL 1.0 1 .0 M 11/23/2001 On 11/20/01 varicella lesions in varying crops >30, L 50 11 P-O ? in office. Y 10/30/2001 11/20/2001 21 PVT PVT none GERD Colic, Pneumonia on 7/01 1
0178282 11/27/2001 WY 12.0 12 F 10/17/2001 On the evening after shot (given around 17:00) pt developed fever and was happier than usual. The next day she was lethargic, confused, decreased strength, incoherent, breathing heavier, had body aches, sore throat and slept all day. Then she was ok. Y 10/10/2001 10/10/2001 0 PUB PUB NONE NONE Hearing loss secondary to history of otitis media as a young child. 1
0178283 11/27/2001 SD 4.0 4 F 11/19/2001 Client reported to have received Varivax on 10/26/1995. Became ill on 10/24/01 with 30-35 pox. Other children around her had chicken pox disease. Y 10/26/1995 10/24/2001 2190 NONE PVT PVT NONE NONE NONE SD01006 1
0178284 11/27/2001 TN 0.5 0 .5 F Mom states had a rash 3 days after vaccinations on 9/18/01. Today, per Mom, same rash on abdomen, tiny red dots. Gave dose of Benadryl with no change-child appeared fine. No fever at present time-97.9. U 11/19/2001 11/19/2001 0 PVT PVT rash~DTaP (no brand name)~2~0.00~In Patient 1
0178285 11/27/2001 TN 0.2 0 .2 M 11/12/2001 Pt became limp and extremely pale after vaccination administration within 2-3 minutes. Slight cyanosis around mouth. Y 11/06/2001 11/06/2001 0 PVT PVT NONE NONE 1
0178286 11/27/2001 GA 51.0 51 F 11/09/2001 Cellulitis left deltoid within hours after pneumovax injection. Cleared with ? Y Y 11/07/2001 11/07/2001 0 NONE PVT PVT Hemochromatosis 1
0178287 11/27/2001 MI 2.2 2 .2 F 11/19/2001 Pt had erythematous, hot hard, area on right thigh measuring 15 X 181/2 cm. Circumference of right thigh 30cm, left thigh 27 cm. Y 11/14/2001 11/15/2001 1 Cellulitis PVT OTH NONE NONE NONE 1
0178288 11/27/2001 TX 12.0 12 F 11/09/2001 Pt dizzy, weak, pale, white lips, and nausea the next day. Site up to much of shoulder blade painful. Pt has cough, hoarseness. Advised Mom to take her to Dr on 11/09/01. Y U 11/08/2001 11/08/2001 0 PUB PUB NONE NONE TX01175 1
0178289 11/27/2001 NY 4.0 4 F 11/19/2001 Parent reports 24 hours after vaccination area erythematous, indurated, warm, unable to ambulate on 11/16. Did not call physician. Called physician on 11/17 at 8 PM, leg swollen involving knee and 18 X 14 cm indurated, warm, erythematous. Negative cellulitis. Y Y 11/15/2001 11/15/2001 0 Lyme blood culture pending. ESR=30. (See form for other equations written that I don't understand.) PVT PVT NONE NONE 1
0178290 11/27/2001 MI 1.25 1 .3 M 11/16/2001 Pt had leg swelling 24 hours after Hib shot. U 11/15/2001 11/16/2001 1 PVT PUB NONE NONE NONE 1
0178291 11/27/2001 CO 0.2 0 .3 F 11/15/2001 Pt had uncontrollable screaming about 12 hours straight, fever, lump where shot was given. Y Y 11/13/2001 11/13/2001 0 NONE PUB PUB Tylenol given before shots NONE Lactose intolerant 1
0178292 11/27/2001 SD 1.0 1 .0 F 10/26/2001 Mom states child had nonstop crying for 45 min around 8 PM on 9/15/01. She couldn't do anything that would stop her from crying. Child arched her back and acted as if in severe pain. Took child to ER in DeSmet. Child seen by Radish, PA. No fever, or other symptoms or signs. Mom states child relaxed and settled down down as they approached DeSmet City limits. Y Y 09/14/2001 09/15/2001 1 PUB PUB NONE NONE SD01005 1
0178293 11/27/2001 SD 1.43 1 .4 M 10/29/2001 On 12/16/97, 9 months after immunizations were given, mother reported that child would not walk after last injection for 2 weeks and he saw Dr 3 times. She thought the clinic had contacted me. I had not had any communication with the Dr. or clinic. I called Dr and spoke to his nurse. She read me pt's progress notes. they said nothing about inability to walk. Child was seen by Dr on 3/21/97 and 2 more times. Progress notes stated child had elevated WBC, ear infection and cold. Received Rocephin injections for treatment. Nurse said Dr did consider a possible reaction to MMR also, but notes are more suggestive of infection as cause. Nurse advised a consult with family physician prior to giving 2nd MMR when it was due. I cannot find a record that I ever filled out a VAER report at that time. Patient was now ready to start kindergarten and Mom brought him in for boosters. She did not mention the previous reaction. I read my notes on child's immune record. I contacted Dr for review of pt's record. He called me back and said he had reviewed the record and consulted with Dr, pediatrician. He said to give pt a 2nd MMR due to his illness back in 1997. I went ahead and administered the pt's other pre-school boosters, but did not give 2nd MMR. We had noted Dr's orders for no 2nd MMR in his record on SDIIS. Y Y 03/12/1997 PUB PUB NONE NONE SD01004 1
0178294 11/27/2001 CA 2.0 1 1 M 11/10/2001 Pt's right thigh and leg indurated with height of 12 mm X 14mm to the side. Y 11/07/2001 11/07/2001 0 PUB PUB NONE NONE CA010130 1
0178295 11/27/2001 CA 16.0 16 M 11/01/2001 Pt Pt had already received the first 3 shots. Asked pt if he was ok and he stated yes. Pt was nervous. After the hepatitis shot pt's face was pale, he lowered his head and passed out. Ammonia inhalant started and pt's body started to seizure X 30 seconds. Care given and pt come out of it without any problem. Went home without any problem. Y 10/01/2001 11/01/2001 31 PUB PUB NONE Calobi? with amblyopia CA010129 1
0178296 11/27/2001 CA 4.75 4 F 10/30/2001 Mother called at approximately 4 PM and stated that child started vomiting this morning. Child had vomited 4 times and mother states that chile appears pale and c/o of anorexia, nausea and abdominal pain. Y 10/29/2001 10/30/2001 1 NONE PUB PUB NONE NONE NONE CA010124 1
0178297 11/27/2001 NC 0.5 0 .4 F 11/14/2001 Twenty four hours post vax, pt ran a temperature of 103 and was taken to the ER. Pt had runny nose and cold, and mother was told that fever was probably from shots. Y Y 09/07/2001 09/08/2001 1 PUB PUB NONE 1
0178298 11/27/2001 ND 12.0 12 F 11/14/2001 Pt called MD office after receiving Hepatitis B vax at school and reported rash at injection site. School secretary called MD later saying rash had spread to leg. She was advised to call parents for authorization for medical attention. Public health nurse called parent the following day. Pt's rash had become generalized, and she received treatment with Claritin which cleared up the rash. Y U 11/13/2001 11/13/2001 0 PUB PUB ND0113 1
0178299 11/27/2001 TN 62.0 62 F 10/09/2001 Pt reported redness with itching 3 days post vax. She had redness with some swelling noted on front of arm beneath area of injection. She used cold compresses on area. She had two small superficial areas noted on left arm/shoulder on day of injection. U 10/05/2001 10/08/2001 3 NONE PUB OTH Lipitor, Lasix Puncture wound right index finger Hypertension, hyperlipidemia 1
0178300 11/27/2001 MI 4.0 4 M On 11/15/01, pt developed swelling. Y 11/14/2001 11/15/2001 1 PVT OTH NONE NONE 1
0178301 11/27/2001 MD 43.0 43 M 11/16/2001 Pt developed light red erythematous splotches around injection site. These splotches were slightly indurated and very tender. Pt had a very tender chain of lymphadenopathy in left axilla. U 11/07/2001 11/07/2001 0 OTH OTH Effexor XR, Motrin, Vicodin ES Chronic obstructive pulmonary disease Anaphylactic reaction to spinach 1
0178302 11/27/2001 70.0 70 M 11/15/2001 Pt developed severe muscle pain in right deltoid at injection site within 12 hours. Within 24 hours, he developed redness, swelling, heat and hardness to touch on medial upper extremity and into elbow. U 11/13/2001 11/15/2001 2 OTH OTH 1
0178303 11/28/2001 NM 0.2 0 .2 F Baby died at home early AM on 11/16/01. Autopsy results received state cause of death as pneumonia. There is an umbilical hernia; occasional posterior epicardial petechiae and pleural surfaces also have scattered petechiae on the visceral pleura and the parenchyma exudes slight to moderate amounts of blood and frothy fluid. The lungs show congestion, patchy interstitial and peribronchial acute and chronic inflammation with areas of edema bilaterally. The lungs had focal areas of pneumonia which demonstrated clusters of gram-positive cocci. Immunohistochemical staining of lung was positive for Streptococcus pneumoniae. There are scattered petechiae on the superior surface of the diaphragm. The liver and spleen are congested as are the kidneys. The brain has diffuse congestion, rare eosinophilic degeneration of neurons in the hippocampus and an infantile architecture. The adrenal has congestion and focal hemorrhage. Esophagus and stomach with mild chronic inflammation and scattered eosinophils. The thyroid has congestion. Y 11/16/2001 N 11/12/2001 11/16/2001 4 O2 sat-nml; ASD by echo screening L more than right; Chromosomes not drawn yet Per autopsy F/U polybacterial pneumonia, including Streptococcus pneumoniae; failure to thrive (small for age); GI Reflux disease PVT PUB Albuterol; Pulmicort; Zantac; Reglan Dysmorphic syndrome suspected; ASD; GE Reflux; Chronic respiratory symptoms; developmental delay; URI; questionable heart disorder 1
0178304 11/28/2001 SC 72.0 F 11/21/2001 A physician reported that a 72 year old female rec'd an injection of Flu Shield (2001-2002 formula) in 10/01. Immediately following immunization, the pt felt tired, run down, feeling bad all over and achy. On 11/8/01, she was hospitalized with acute renal failure. The pt was also diagnosed with rhabdomylysis and placed on dialysis. On 11/19/01 the pt was discharged to a nsg home where she remains on dialysis. Y 11 U 10/01/2001 11/08/2001 38 UNK OTH OTH UNK UNK UNK HQ8673521NOV2001 1
0178305 11/28/2001 IN F 11/21/2001 A pharmacist reported that a female pt received an injection of Pnu-Imune 23 on 11/14/01 and developed seizures the same day. The seizures persisted and the pt was hospitalized on 11/15/01. The reporter noted that the pt had been seizure-free for 3 years prior to the onset of the event. No further information was available at the date of this report. Y U 11/14/2001 11/14/2001 0 UNK OTH OTH UNK UNK Concurrent conditions: convulsions NOS HQ8577019NOV2001 1
0178306 11/28/2001 SC 1.25 1 .3 M 10/12/2002 A mother reported that her son rec'd his fourth doses of Hib-Titer and DTaP (manufacturer unknown) vaccines on 10/7/99 at 15 months of age. Within 1 month post vaccination, the child developed an ear infection and a urinary tract infection. Soon after, the child was not sleeping, became hyperactive and began talking incessantly. Subsequently, the child's behavior regressed significantly, and he was diagnosed with regressive autism in may 2001 at 34 months of age. The mother reported that vitamin therapy and a diet "free of milk and wheat products has improved her son's behavior. Autism is considered to be medically important. Follow up information received from the physician on 12/12/01 identified Infanrix as the DTaP vaccine administered on 10/7/99. The physician noted that the child was last seen on 1/8/00; the child's medical records were subsequently transferred. A copy of this report has been forwarded to manufacturer of Infanrix vaccine. A legal complaint was received from an attorney on 5/24/02. The legal complaint indicated that the child received injections containing toxic mercury in the form of thimerosal in approximately 15 doses administered by his pediatricians between birth and the age of 2. According to the legal complaint, before completing the schedule of Thimerosal injections, the child developed normally for his age. At approximately 15 months of age, the child allegedly began to display the symptoms of neurological injury associated with exposure to toxic mercury included, the loss of language, a decline in cognitive skills, repetitive and sterotypical behaviors, loss of effect, regression of social interpersonal skills, and persistent severe gastrointestinal problems. According to the legal complaint, the neurological injuries suffered by plaintiffs caused severe emotional and behavior problems. The child has allegedly been diagnosed as suffering from disintegrative Autism. The legal complaint noted that certain children, including plaintiffs, are for various reasons especially vulnerable to suffering neurological damage upon exposure to toxic organic mercury as contained in Thimerosal. Y U 10/07/1999 05/01/2001 572 UNK OTH OTH NONE UNK UNK Lethargy, a~Varicella (Varivax)~~0.00~In Patient HQ8573219NOV2001 1
0178314 11/28/2001 FL 15.0 16 F 12/27/2002 Cold symptoms and lymph adenopathy prior to menstrual cycle period (menses began). Admitted to the hospital for diagnosis and treatment 11/07-11/09. Saw nephrologist. Began Predinsone. Follow up report states "Continues with Nephrotic syndrome, S/P Renal Biopsy, Minimal change, Ongoing treatment required-Pediatric Nephologist." Y Y 2 N 11/02/2001 11/04/2001 2 Proteinuria; rapid wt gain PVT PVT Alka Seltzer (prior) Cold NONE 1
0178315 11/28/2001 PA 69.0 68 M 11/13/2001 Knee pain, stiffness and swelling developed post vax. Dx'd with osteoarthritis due to booster. Medicines and treatment with Vioxx, Voltaren, Celebrex, steroid injection, arthroscopy, non-steroid medication and knee braces. Per 1 year follow up: Pt has not recovered. NOTE ATTACHED. 12/16/2002 As of today, I am still wearing braces on both knees when I walk. The pain never goes away. I take from 6 to 8 Extra Strength Tylenol every day. It helps some but not completely. As I have stated before I have never had any problems of any kind with my knees until I took the booster shot in April of 2000. About a month later I could hardly walk, and as they say the rest is history. i thank you for your interest. Signed, Pt Y N 04/04/2000 05/01/2000 27 ESR, BMP, HLA-DR4, ANA, RF PVT UNK verapamil, Diovan NONE HTN 1
0178316 11/28/2001 PA 47.0 54 M 11/22/2001 Flu shot. Guillian Barre Syndrome, onset diagnosis 11/22/2001. Now in hospital on treatment. Per 1 year follow up: It is unknown if pt has recovered. Last seen 01/08/2002. Residual symptoms presented at 01/08/2002. Hyporeflexia and mild distal sensation. Follow up 12/13/2001: Phone # of comany who gave on original report." Y Y Y N 11/06/2001 11/15/2001 9 No spinal fluid cells. Arreflexia, weakness, spinal fluid protein increased. OTH UNK Zocor NONE Hypercholesterolemia 1
0178317 11/28/2001 CA 1.3 1 .3 M 11/20/2001 Pt had a seizure on 10/22/01, the day of required vaccines. It lasted 20 minutes. Y Y 2 Y 10/22/2001 10/22/2001 0 PVT PUB Phenobarbital Static encephalopathy; Seizure Disorder; Cerebral Palsy Seizure~Measles + Mumps + Rubella (no brand name)~1~1.00~In Patient 1
0178318 11/28/2001 FL 0.4 0 .4 F 10/20/2001 After second shot, congestion and wheezing (2-3 weeks after). After 4th shot uncontrolled screaming for hours, eyesight seemed off, legs would turn purple and puffy, development delay started, stopped using left hand. After 6th shot started infantile spasms and seizures. A follow up report received 11/30/2001 adds: After the 4-month vaccinations on 3/12/1996, the pt's mother first noted the developmental delays (poor eye focus, left arm weakness, loss of use of left hand). She states there is a note in her daughter's medical record that the doctor's office noted developmental delays between 3-4 months of age, but these delays are not specified. At the time of the 6-month vaccinations, the child was being treated with antibiotics for otitis media. After these vaccinations, the child began to exhibit almost constant "jerking" movements. These continued for about 2 months. They were later diagnosed as infantile spasms. By 1 year of age, the child began experiencing "grand mal" seizures for which she was hospitalized and medicated with Ativan. The seizure episodes were 2-4 hours in duration. Mother describes child as "turning blue" prior to these seizures. After the 18-month vaccinations, including DPT, the child's seizures again became very difficult to control and several different anti-epileptics were tried in various doses. At age 1 1/2, child had normal vocabulary, but by age 3, she stopped using speech to communicate. In Oct 2000, the child underwent right brain surgery. Portions of the brain were excised and a stimulator was placed in the brain. Pre-op EEG showed all lobes of brain demonstrated "focal seizures". Currently, seizures are generally well controlled, but the child has exacerbations whenever she is ill with an infection such as chronic sinusitis. Child continues to become cyanotic at onset of seizures. At one point sinus surgery was performed, but the effects were temporary. All allergy tests have been negative to date. Pt's eyesight is so poor that she is classified as legally blind. Y Y N 03/12/1996 03/26/1996 14 Epileptic. Non-hemiparesis and CP on left side. PVT UNK Right ventricle in brain dilation, mild micrephaly, interuterine growth retardation Reaction unevaluable~DTP (no brand name)~1~0.00~In Patient 1
0178319 11/28/2001 KS 0.5 0 .5 M 11/16/2001 Jerking of head and right arm for 5-10 seconds at 3 separate time. Y 1 Y 11/13/2001 11/13/2001 0 EEG-results pending PVT PVT 1
0178320 11/28/2001 MA 1.3 1 .3 F 11/16/2001 Vaccine MMR given 10/10/2001. 10/17/2001 fever. 10/20/2001 rash, twitching, myozlmic jerks. Y Y 3 Y 10/10/2001 10/17/2001 7 Spinal Fluid-nml PVT PUB NONE NONE 1
0178321 11/28/2001 NY 62.0 62 F 11/15/2001 Approximately 7 to 10 days after receiving the vaccine, the patient experienced a temperature of 104F, cough, cold, chills, and aches. Y N 10/17/2001 Chest x-ray UNK UNK NONE High blood pressure and stress. 1
0178322 11/28/2001 MS 45.0 45 F 11/20/2001 The patient experienced raised areas bilaterally. The patient complained of pain in her neck and lymphadenopathy. Y U 11/14/2001 11/19/2001 5 PUB PUB Premarin NONE Uticaria 1
0178323 11/28/2001 TX 6.0 6 F 11/20/2001 Post vax the patient was seen with a 9cm x 7 cm area of erythema, swelling and warmth at the site of the flu shot. Y Y 11/06/2001 11/06/2001 0 NONE MIL MIL NONE NONE NONE 1
0178324 11/28/2001 AL 50.0 50 F 11/19/2001 The patient experienced redness, swelling, warmth and muscle tremors at the site of the injection. The patient also had a fever and chills. Y Y 11/02/2001 11/02/2001 0 NONE OTH PVT Zyrtec, Glucophage, Spenolactone, Atenolol and Premarin. NONE Allergies and diabetes. 1
0178325 11/28/2001 NE 10.0 10 F 11/16/2001 About 2 hours after receiving Hepatitis B vaccine in the right arm, the patient experienced tingling fingers and edema. Y Y 11/16/2001 11/16/2001 0 NONE PVT PUB Adderall NONE Asthma 1
0178326 11/28/2001 MO 44.0 44 M 11/16/2001 The patient had pain at the injection site, joint pain and hives. The patient was treated with Atarax, ice to the site and Tylenol. Y 10/24/2001 10/26/2001 2 NONE PVT PVT NONE Allergic to ibuprofen, sulfa, Cipro and EES. 1
0178327 11/28/2001 WI 22.0 22 F 11/19/2001 2 1/2 hours post vaccine, the patient experienced a headache with blurred vision which lasted until the next day. 4 hours post vaccine, the patient's finger tips became numb and 5 minutes later the patient's tongue became numb. This lasted for about 15 minutes. Y 11/15/2001 11/15/2001 0 MIL OTH Orthocycline NONE NONE 1
0178328 11/28/2001 CA 40.0 40 M 11/19/2001 The patient experienced pain in the deltoid immediately after the injection. The patient was fatigued and light-headed three hours later. The patient had a fever of 99.8F six hours later. The patient's stomach was upset 12 - 48 hours and he could not work for 2 days. Y 11/14/2001 11/14/2001 0 OTH PUB NONE NONE NONE Fever~Influenza (Seasonal) (no brand name)~1~30.00~In Patient 1
0178329 11/28/2001 NH 60.0 M The next morning, 14 hours later, the patient was very dizzy, cold sweat and vomited. One week later the patient was dizzy again in the morning. Y PUB OTH NONE NONE 1
0178330 11/28/2001 MO 56.0 56 F 11/19/2001 The patient experienced a terrible headache and facial swelling, especially upper and lower eyelids. The patient experienced extreme weakness the rest of the day and evening. Y 10/26/2001 10/27/2001 1 OTH PVT Allegra-D, Synthroid and Prempro. 1
0178331 11/28/2001 OR 70.0 70 F 11/20/2001 The patient experienced severe hives all over her body beginning on 10/19/2001. The patient took various anti-histamines and was given a shot in the Dr's office. The patient is now taking Zyrtec, which so far reduces the hives. Y N 10/18/2001 10/19/2001 1 PVT OTH NPH, Humulin, insulin and spironolactone. NONE Diabetes 1
0178332 11/28/2001 NC 37.0 37 F 11/09/2001 The patient's right upper arm was swollen, firm and painful with increased heat in an area 10cm x 10cm. Y Y 10/25/2001 10/25/2001 0 NONE OTH PUB NONE NONE Asthma and pneumonia. 1
0178333 11/28/2001 NC 65.0 65 F 11/06/2001 The patient experienced a 5 1/2" x 4 1/2" area of erythema and edema around and below the injection site with a tender node of the left axilla. Y Y 10/18/2001 10/18/2001 0 NONE PUB PUB NONE Degenerative joint disease 1
0178334 11/28/2001 CA 57.0 57 F 11/12/2001 The patient developed hives within 15 minutes of receiving the vaccine. The patient was 1st treated wtih Benadryl cream or pills. After 2 weeks and they still kept appearing, the patient was treated with methylprednisolone tablets. Y 10/23/2001 10/23/2001 0 PVT OTH Arava, Premarin, Folic acid, Actonel, and Methotrexate Arthritis and osteoporosis. 1
0178335 11/28/2001 DE 49.0 49 F 11/16/2001 Post vaccine, the patient experienced redness, swelling, tenderness to the touch and nausea. The patient felt hot and sick after the injection. The patient was treated with Atarax and Zyrtec. Y Y 11/14/2001 11/14/2001 0 PVT PVT Cervical dysplasia and diverticulosis. 1
0178336 11/28/2001 CA 66.0 66 M 11/12/2001 The patient continues to have muscle tenderness with movement of the left upper extremity. The patient denies tenderness to touch at the injection site. N 10/10/2001 10/10/2001 0 PVT PVT Prinivil, Glucophage, Calipizide, Zocor and Prevacid. NONE Type II Diabetes, Hypertension, elevated cholesterol. 1
0178337 11/28/2001 CA 32.0 32 F 11/19/2001 The patient experienced a fever of 103F and severe myalgia for 3 days with malaise. The patient woke with these symptoms the morning after receiving the vaccine. The patient took time off work and still feels weak. N 11/14/2001 11/15/2001 1 PVT PVT UNK NONE 1
0178338 11/28/2001 NH 52.0 52 F 11/20/2001 On 11/14/2001 at approximately 8:00 pm the patient experienced cold chills, nausea, aches and a temperature of 102F. On 11/15/2001 at 4:00 am, the patient had improved. Y 11/14/2001 PVT PVT Clonidine, Plavix, Vagifem, Flonase, Patenol and Pancrease. Hypertension. 1
0178339 11/28/2001 GA 74.0 74 F The patient's arm is swollen, inflammed and quite warm. The patient was treated with Decadron, Depo Medrol and Levaquin. U 11/15/2001 11/15/2001 0 PVT UNK NONE Allergic to iodine/shellfish, previous mastectomy and lymphoma. 1
0178340 11/28/2001 MA 31 F 11/16/2001 Within 24 hours post vax arm injection site became swollen, hot and tender. Area of redness measured 3" X 2". 11/13/2001 11/13/2001 0 PVT UNK 1
0178341 11/28/2001 PA 13.0 13 F 11/20/2001 The patient experienced local redness and swelling at the area of the injection and a fever. Y 11/16/2001 11/16/2001 0 NONE PVT PVT NONE Exercise asthma and allergic to Zithromax and Augmentin. 1
0178342 11/28/2001 AZ 59.0 59 M 11/20/2001 The following morning after receiving the vaccines, the patient's arm hurt and turned red for 3 days. The patient's temperature was 101F for 2 days and his whole body ached for 2 days. All symptoms were resolved after 3 days. Y 11/16/2001 11/17/2001 1 PVT PVT Lipitor and Claritin. Hyperlidpidemia and smoker. 1
0178343 11/28/2001 MD 48.0 48 M 11/19/2001 The patient developed a small ulceration under his bottom right lip approximately 1 week post vax. The patient also developed a superficial ulceration under his right nares when he got a shot from his personal physician. N 11/05/2001 11/13/2001 8 NONE OTH OTH Zebeta and Zestril. NONE Stent in heart vessels due to blockage. 1
0178344 11/28/2001 WI 63.0 63 F 11/19/2001 Within 24 hours after the immunization the patient developed a headache, tenderness at the injection site and left sternoclavicular swelling. The patient's temperature increased. The patient denies redness over the swollen area. The patient's headache and swelling resolved completely within 24 hours of their onset. Y 11/13/2001 11/14/2001 1 NONE PUB PVT NONE Hyperlipidemia, CAD, Hypertension and chronic back pain. 1
0178345 11/28/2001 MI 11.0 11 F 11/19/2001 The patient experienced a large local reaction of the left arm with a 5cm x 7cm red, swelling area. U 11/12/2001 11/13/2001 1 NONE PVT PVT Advair, Singulair, Proventil, Tylenol and Afrin. Allergic to sulfa and Vonwillebrands Disease. 1
0178346 11/28/2001 CT 62.0 62 F 11/21/2001 Three days post vax the patient complained of a sore throat and cough. The patient did not have a fever or chills. The patient saw the MD and was advised she has a viral infection associated with the flu shot. Y 11/08/2001 11/11/2001 3 PUB PUB 1
0178347 11/28/2001 OR 50.0 50 F 11/19/2001 The patient experienced redness at each injection site two days after the injection. The patient expereinced a fever 1 hour after the injection. The patient devleoped an irregular heartbeat, light headedness and shortness of breath. U 11/16/2001 11/16/2001 0 OTH UNK Adderal, Imitrex, Remeron, Premarin, Celexa and Depakote. Asthma 1
0178348 11/28/2001 AZ 8.0 8 F 11/20/2001 A few hours post vaccine, the patient developed a rash under her arms. The patient was treated with Azmacort MDI. The next morning the rash had spread to the patient's stomach and back. A baking soda bath was given and 24 hours later the rash was completely gone. Y 11/16/2001 11/16/2001 0 NONE PVT PUB Albuterol and Azmacort. 15 minute wheezing attack the night before the vaccine. Asthma 1
0178349 11/28/2001 IL 71.0 71 F Post vax the patient complained of intermittent daily pain at the injection site. Y 10/15/2001 10/20/2001 5 PUB PUB NONE NONE NONE 1
0178350 11/28/2001 NY 51.0 51 F 11/26/2001 On 11/25/2001 the patient states she was ill with muscle aches, felt feverish, sneezing, sore throat and green nasal secretion. The patient states she was feeling better on 11/25/2001. On 11/26/2001 the patient made a follow up phone call and states she is at work and feels better. Y 11/12/2001 11/24/2001 12 NONE OTH PVT NONE NONE NONE 1
0178351 11/28/2001 MN 36.0 36 F 11/19/2001 On 11/19/2001 the patient called to report having numbness and loss of feeling to the left hand and arm on 11/17/2001. The physician instructed the patient to call Dr for further follow-up. U 11/16/2001 11/17/2001 1 OTH PUB Lactulose syrup, Axid, Docusate Sodium, Lasix, Spironolactone and multivitamin. 1
0178352 11/28/2001 TX 44.0 45 F 11/26/2001 The patient states her left ear and left side of her face became hot within a few minutes post vax. The patient took Benadryl and was OK in about 15 minutes. Y 10/26/2001 11/26/2001 31 OTH PVT NONE NONE 1
0178353 11/28/2001 GA 1.0 1 .1 M 11/17/2001 At 4:00 pm the day of the vaccines, the child noted a rash. The rash was on his face, chest, back, arms and legs. The patient was treated with Benadryl. Y 11/13/2001 11/13/2001 0 NONE PVT OTH Vitamin/Iron supplement NONE NONE 1
0178354 11/28/2001 NM 0.6 0 .6 F 11/20/2001 Pt developed a seizure associated with a fever of 104.8F and crying. Y Y 11/20/2001 11/20/2001 0 NONE PUB PUB NONE NONE NONE 1
0178355 11/28/2001 AR 0.2 0 .2 F 11/27/2001 Pt developed inconsolable crying and was treated with Motrin and Tylenol. Y Y 11/16/2001 11/16/2001 0 PVT PUB NONE NONE NONE 1
0178356 11/28/2001 AR 0.3 0 .4 M 11/21/2001 Pt developed redness and swelling to left thigh and uncontrollable crying. Treated with Motrin, cool compresses and hydrocortisone cream. Y Y 11/20/2001 11/20/2001 0 PVT OTH NONE 1
0178357 11/28/2001 WI 0.5 0 .6 F 11/15/2001 Pt developed seizure activity, including twitching of face/head and arm jerking which occurred in "clusters" per mom of 5-10 minutes, lasting a total of 30 minutes with spontaneous resolution. Y Y 11/14/2001 11/14/2001 0 Head CT-nml; Labs (electrolytes, CA, Phos, Mg-all nml PVT PVT NONE NONE NONE 1
0178358 11/28/2001 CT 1.0 1 .0 F 11/21/2001 At least 4 vesicles were noted on left arm at site of varicella vaccine. Varicella vaccine was given on 11/9/01 and the rash was noted 12 days later on 11/21/01. Y 11/09/2001 11/21/2001 12 PVT OTH NONE NONE Frequent ear infections 1
0178359 11/28/2001 AZ 0.3 0 .3 F Immunizations given about 13:30. Mom noticed a red area at the Prevnar site at about 18:00. Y 11/20/2001 11/20/2001 0 NONE PVT OTH NONE NONE 1
0178360 11/28/2001 PA 1.25 0 .8 F 11/20/2001 1 day, post vax, the child had hives on her arms and legs. Also, she had a fever but had concurrent viral illness. Y 05/22/2001 05/23/2001 1 NONE PVT OTH NONE Viral illness NONE 1
0178361 11/28/2001 CA 2.0 2 .2 F 11/15/2001 Pt developed cellulitis on right upper thigh around injection site, 2-3 days after injection. Pt was started on antibiotics. Y U 11/13/2001 11/15/2001 2 OTH OTH Septra Sinusitis (resolving) RAD X 1 1
0178362 11/28/2001 MI 1.25 1 .3 M 11/21/2001 6 hours, post vax, pt had an onset of profuse frequent diarrhea, continuing for 5 days, at time of visit on 11/21/01. Y N 11/16/2001 11/16/2001 0 NONE PVT OTH NONE NONE NONE 1
0178363 11/28/2001 CA 1.25 1 .3 M 11/15/2001 Right thigh had 5cm redness; central bluish discoloration 1cm; had pain and tenderness with swelling. Had a fever X 2 days but none today. Right hip and knee FROM; pt walking well. Will follow-up over the next week. U 11/13/2001 11/14/2001 1 NONE OTH OTH NONE NONE NONE ~Vaccine not specified (no brand name)~~0.00~In Sibling 1
0178364 11/28/2001 HI 0.2 0 .2 F Pt developed irritability about 8 to 12 hours, post vax. No fever. Brought to my attention on the 4th day, post vax. She was given Tylenol. U 11/14/2001 11/14/2001 0 PVT PVT NONE NONE NONE 1
0178365 11/28/2001 MD 2.0 1 .9 F 11/20/2001 2 year old pt given Lymerix IM instead of Hep-B. Y 11/19/2001 11/19/2001 0 PVT PVT NONE NONE NONE 1
0178366 11/28/2001 MN 66.0 64 F 11/14/2001 1 week after 2nd Lyme shot, wrist, fingers, & ankle joints began to ache and still ache almost 18 mo later. * 1st shot was 4/25/00 Y 06/01/2000 06/07/2001 371 NONE PVT PVT Armour's thyroid, Promana, Fosamax, generic tylenol, Fiorinal when needed. NONE hypothyroidism, migraines, borderline osteoporosis 1
0178367 11/28/2001 MN 8.0 2 .6 F 11/12/2001 11/6/01 started fever 102F range, severe HA, sore throat Sx all continued into 11/9/01. Lesions started 11/9/01, 11/9/01 3+ erythematous tonsils with petechia strep (-), bronchospasmatic cough with expiratory wheeze, fever resolved 11/10/-11/11/01. 11/9/01 started Acyclovir 600mg. Y Y 07/18/1995 11/06/2001 2303 strep cx 11/9/01 negative PVT OTH none NONE NONE 1
0178368 11/28/2001 AL 48.0 48 F 11/20/2001 Seizure with anaphylaxis Y Y 11/06/2001 11/06/2001 0 CT head, blood work PVT PVT NONE DM,hearing loss 1
0178369 11/28/2001 SC 1.0 1 .0 M 11/16/2001 Abscess at injection site L deltoid area. Y Y 10/19/2001 11/12/2001 24 PVT PVT Rx- Augmentin for treatment of abscess NONE 1
0178370 11/28/2001 IN 1.4 1 .3 M 11/16/2001 T-102F 11/13/01. ER 11/14/01 18:00 T-105F, P 148, R 32, O2 sat 96%, course rhonchi, runny nose, pulls ears. Completed Amoxil 11/14/01. Impression: Fever, OM, Tonsillitis, Feverall 120mg supp, Rocaphin 500mg IM Y U 11/05/2001 11/13/2001 8 CBC WBC 12,000 Strep (-) PVT PVT Amoxil BOM 1
0178371 11/28/2001 VA 1.0 1 .0 F 11/21/2001 Pt developed 3 vesicles on chest, 4 vesicles on back, and 1 vesicle behind ear. U 11/06/2001 11/20/2001 14 PVT PVT Cough 1
0178372 11/28/2001 MN 45.0 44 F 11/02/2001 Received Hepatitis B series. First shot, no reaction. Second shot, arm ached significantly. Third shot, whole body ached, felt weak in arms (resolved by next day). Y 08/24/2001 08/24/2001 0 NONE PVT UNK OTC-aspirin NONE Denies allergies 1
0178373 11/28/2001 CT 4.0 1 .6 M 11/19/2001 Details are unclear but he had a seizure within 2-3 days of having the immunization and also had increased temper tantrums within 1-2 week period. Y 07/13/1998 07/14/1998 1 CSF/LP-neg; CT-neg PVT OTH NONE Temper tantrums 1
0178374 11/28/2001 32.0 32 M 11/07/2001 Pt developed urticaria, dizziness and pallor 15 min after injection. He was given 2 liters IV fluid (lactated ringers) and 25mg of Benadryl with reversal after 30 minutes. He resumed activity after 8 hours. Y Y 10/23/2001 10/23/2001 0 NONE MIL MIL NONE Allergy to penicillin 1
0178375 11/28/2001 CA 0.2 0 .1 F 11/15/2001 Hypotomic/hyporesponsive episode, pallor/floopy. Paramedics to ER. Recovered completely. Y Y 09/06/2001 09/06/2001 0 Glucose-wnl PVT PVT NONE NONE 1
0178377 11/28/2001 AZ 4.0 4 F 11/17/2001 Pt had redness and swelling noted, starting on 11/15/01 PM. It was less red in the office on 11/16/01 AM. The left upper arm and lower deltoid area was red 7cm X 10cm, with induration which had more intense redness in the center of this area (4cm X 6cm). Pt was given Benadryl, po. Y 11/15/2001 11/15/2001 0 NONE PVT PVT NONE NONE NONE 1
0178378 11/28/2001 WA 10.0 10 F 11/05/2001 Pt had a half-dollar sized rash at the site of injection. Treated with Benadryl po with relief. Y 10/25/2001 PVT OTH Benadryl NONE Allergies to grapes 1
0178379 11/28/2001 NC 39.0 39 F 11/16/2001 Symptoms began about 35-37 minutes, post vax. She began to feel "funny"; legs felt weak and then passed out. She does not recall anything until waking on the ambulance. She was sent to hospital ER and kept X 5 hours. She became stable and all labs were ok. Bed rest X 48 hours. Y Y 11/14/2001 11/14/2001 0 EKG; Labs; UA OTH OTH Paxil; Synthroid NONE Allergy to PCN 1
0178380 11/28/2001 ME 12.0 12 F 11/19/2001 Left arm with erythema, warmth and pustular vesicles surrounding injection site about 7-10 days later. In recovery process on antibiotic. Y U 11/05/2001 11/16/2001 11 Clinical evaluation PVT PUB Zyrtec 10mg qd NONE Allergic rhinitis; eczema 1
0178381 11/28/2001 WI 44.0 44 F 11/21/2001 Pt developed redness, swelling and heat per pt. No treatment. She never had it looked at and informed us of it today (11/21/01) and that it was better. Y 11/19/2001 11/19/2001 0 PVT PVT NONE Allergy to PCN 1
0178382 11/28/2001 WA 9.0 9 F 11/05/2001 Hives U 10/16/2001 PVT OTH Presyncope 1
0178383 11/28/2001 MI 2.0 2 .0 F 10/29/2001 Patient came out of the room and fainted. The doctor and nurses took care of her. When she got home, she ran a fever, vomited and was very sick. The doctor's office kept on calling to check on her. He advised never to get these shots again. Y Y 04/25/1990 04/26/1990 1 PVT PVT NONE NONE 1
0178384 11/28/2001 MN 66.0 66 F 11/14/2001 Pt had intensified wrist, finger and ankle joint pains. Her upper arm was swollen and so painful that it required ice packs. She could not lift or turn her arm or sleep (even with Dalmane and Advil) for 72 hours. Ten days post vax, her arm still hurt when she turned it and at injection site. Y 10/25/2001 OTH PUB Armour thyroid, Premarin, Fosamax, acetaminophen, Fiorinal NONE Hypothyroidism, migraines, borderline osteoporosis joint aches~Lyme (LYMErix)~2~65.00~In Patient 1
0178385 11/28/2001 TN 0.2 0 .2 M 11/16/2001 Lethargy, slept 24-36 hours after shot. Was arrousable but would go back into deep sleep. Decreased eating secondary to sleep. Y 11/13/2001 11/13/2001 0 NONE PVT PVT NONE NONE NONE 1
0178386 11/28/2001 NJ 1.0 1 .1 M 11/21/2001 Pt developed hives 11/1/01. He was seen by MD and given Benadryl. The hives lasted on and off until 11/6/01. Note: Pt had eaten foods with eggs before immunizations. "No problems" per mother. Y Y 10/26/2001 11/01/2001 6 NONE PUB PUB NONE NONE 1
0178387 11/28/2001 NY 28.0 28 F 11/16/2001 Pt developed fine, pin point, red rash on face (non-raised, non-pruritic) 15 minutes after vaccination. Given Benadryl 25 mg PO at 3:33 PM. At 4 PM rash had begun to fade. Pt demanded to leave office at 4 PM, advised to go to ER if any untreated effects. Pt has been seen in office since. No further ill effects occurred after vaccination. Y 10/22/2001 10/22/2001 0 Mantoux 5 US units implanted intradermally right forearm concomitantly. OTH PUB Benadryl PRN Seasonal (fall) allergies 1
0178388 11/28/2001 TX 10.0 10 M 11/19/2001 Pt developed miliary rash on face. He had no lymphadenopathy, fever, or any other signs of rubella. Y 11/06/2001 11/16/2001 10 NONE PVT OTH NONE NONE 1
0178389 11/28/2001 OH 5.0 F 11/09/2001 Mother noted large area of inflammation at site of vax 24 hours after they were given. Pt had a 6 x 6.5 cm area of redness, warmth, tenderness and induration. She was started on Ilosone and Motrin. Y Y 11/07/2001 11/08/2001 1 NONE PUB OTH NONE Upper respiratory illness Allergy to penicillin 1
0178390 11/28/2001 CA 14.0 14 M 11/20/2001 Wthin 12 hours post vax, pt developed a fever of 101, extreme muscle aches and spasms, chills, headache and light sensitivity. He was treated with Motrin and cool bath to bring fever down. Symptoms lasted 3 days. Y 11/15/2001 11/15/2001 0 PVT PVT Sudafed NONE NONE 1
0178391 11/28/2001 OH 68.0 68 F 11/20/2001 Later on in the day of receiving vax, pt's whole arm began to ache. One hour later, the arm began to itch below the injection site. The next day, pt felt like a cold was starting, she had a nonproductive cough which lasted 5 days. Pt saw MD on Friday 11/16 and MD said she had an allergic reaction to PPV. MD treated pt with Iophen DM liquid cough medicine and Avelox. Y 11/10/2001 11/10/2001 0 NONE OTH PVT Vitamin B, Vitamin C, calcium, potassium NONE NONE 1
0178392 11/28/2001 NV 59.0 59 F 11/19/2001 Pt developed dizziness, nausea and anorexia. U 11/19/2001 11/19/2001 0 OTH PUB Premarin, Mobic, Sudafed, ASA NONE Allergy to sulfa 1
0178393 11/28/2001 CA 62.0 62 F 11/05/2001 Within an hour of receiving vax, pt's right arm, from injection site to elbow and 2" above injection site, became red, swollen, painful (could not lift arm) and warm. After 2 hours, pt noted to have a pink line running from armpit down to elbow. Pt was seen on 11/3/01 and given an injection of Cephalosporin and a prescription for antibiotics. She was instructed to follow up with her MD if condition worsened. On 11/5/01, the swelling and redness improved, but pt had a knot at the injection site and it was still tender to touch. Pt had a previous dose of the pneumonia 23 vax in 1994 with no reaction reported. Y Y 11/02/2001 11/02/2001 0 UNK PUB PUB UNK NONE UNK CA010125 1
0178394 11/28/2001 MI 0.8 1 .5 F 11/26/2001 Pt developed rash, erythema and urticaria. Y 10/18/2001 10/27/2001 9 PUB OTH NONE NONE NONE 1
0178395 11/28/2001 PA 8.0 1 .4 M 11/20/2001 On 11/18/01, pt developed pruritic rash on face, extremities and trunk. Pt was afebrile. Y 06/07/1995 11/18/2001 2356 NONE PVT PVT Resolving otitis media Eczema 1
0178396 11/28/2001 IL 5.0 5 F 10/17/2001 Thirty minutes post vax, pt developed facial swelling and hives. She was referred to ER and treated with Prelone and Benadryl. Y Y 10/12/2001 10/12/2001 0 NONE PVT PVT PPD, Aventis, C0833AA, intradermal L arm, 1 previously Allergic to Zithromax, Augmentin, Lorabid, Gentamycin drops, chronic otitis 1
0178397 11/28/2001 AL 4.0 4 U Post vax, pt noted to be sneezing with red eyes and wheezing. Pt was treated with epi and Ventolin updraft with good results. Y 11/15/2001 11/15/2001 0 PUB OTH Duricef NONE NONE 1
0178398 11/28/2001 MN 5.0 5 M 11/16/2001 Eight days post vax, pt presented to office with right unilateral parotitis. Pt had discomfort related to edema. Pt had questionable pain referred to mandible and right neck. Y U 11/08/2001 11/16/2001 8 NONE PVT PVT NONE NONE NONE 1
0178399 11/28/2001 MI 1.25 1 .3 M 11/19/2001 Pt developed a rash approximately 48 hours post MMR. Pt was seen in MD office on 11/16/01 with a rash consistent with German measles. The rash had started caudally. Pt was afebrile and looked good. Y U 11/13/2001 11/15/2001 2 NONE PVT OTH NONE NONE 1
0178400 11/28/2001 NY 1.0 1 .0 F 11/16/2001 Pt developed localized erythema with 2 small urticarial lesions within 5 mins of receiving vax. She developed 2 additional lesions on back 15 minutes post vax. She was given 20mg Benadryl. Y 11/16/2001 11/16/2001 0 NONE PVT PVT Amoxicillin NONE NONE 1
0178401 11/28/2001 CA 1.2 1 .2 M 11/21/2001 One day post vax, pt noted to have swelling at injection site. Then pt developed hives and redness which became generalized from head to feet. Pt was slightly pruritic. Conjunctivae was not involved. On 11/21/01, pt noted to have hives at injection site and a 2 x 3 cm area of erythema along with generalized hives. The hives were somewhat morbilliform-like. Y U 11/19/2001 11/20/2001 1 NONE PVT PVT Amoxil NONE NONE 1
0178405 11/29/2001 NJ 1.5 1 .5 M 11/27/2001 An attorney reported that an 18 month old male received his 5th dose of Acel-Imune, 4th dose of Hib-Titer and his 3rd dose of Orimune on 10/28/1996. In 1/97, at 20 months of age, the child allegedly "began to display symptoms of neurological damage consistent with mercury poisoning" which resulted in "permanent injuries". The reporter described those symptoms as "regression of his language skills, engaging in repetitive behavior, suffering from diminished cognitive ability and becoming socially withdrawn". The reporter attributed these events to the presence of thimerosal. CANCELLED: Upon further review it was determined that this patient received Tri-Immunol vaccine. See MCN HQB948028NOV2001 which will remains the case of record. Y U 10/28/1996 01/01/1997 65 UNK OTH OTH UNK UNK UNK HQ8768926NOV2001 1
0178406 11/29/2001 58.0 58 F 11/20/2001 Pt was given a repeat series of Hep-B vaccine in preparation for a liver transplant. This ADR (adverse drug reaction) occurred following the 2nd injection of the repeat series. Symptoms included: fever to 102.7F, polyarthritis, warm and red knee and ankle joints, myalgias and lethargy. 08/15/2001 08/20/2001 5 No surface antibody titers of Hep-B were checked; apparently, it is routine to re-vaccinate pts for Hep-A and Hep-B prior to transplant. UNK UNK History of primary biliary cirrhosis with jaundice and ascities. 1
0178407 11/29/2001 AR 49.0 48 F 10/31/2001 Approx. 1 3/4 hours, post vax, the pt called the Pharmacy complaining of severe headache and chest tightness. The pt was counseled to take a dose of oral Benadryl if available and seek immediate medical attention at a medical facility. She was treated and released at the ER by a physician. Y Y 10/30/2001 10/30/2001 0 OTH PVT NONE NONE 1
0178408 11/29/2001 NC 50.0 50 M 11/12/2001 On 11/9/01, pt had a red area on right arm at injection site that was painful. On 11/9/01 and 11/10/01 he had nausea and 1 episode of vomiting. On 11/10/01, he had a numb sensation on right forearm and a burning on right foot. On 11/12/01, the red area was 8cm in diameter. He also had a fever of 101.2F on 11/9/01. Pt is improving. By 11/12/01, all was resolved. Y 11/08/2001 11/09/2001 1 PVT PVT Zosyn; MVI; ASA; Levofloxacin; oxycodone APAP; alprazolam; Evoxac Osteomyelitis mandible NC01101 1
0178409 11/29/2001 66.0 65 M 11/28/2001 This report has not been verified by a physician or other healthcare professional. Medical history, concurrent medications were not specified. The pt reported that he received 3 injections of Lymerix. the 1st injection was given in 1999, and the last one was given in 2000, exact dates of of IZ's not reported. In July or August of 2001, the vaccinee reportedly he began to experience burning pain in the joints of his left hand. He then experienced the burning joint pain in his left elbow, right toe, and right knee. The vaccinee reported that he has not sought medical attention for the burning joint pain persisted as of 11/14/2001. the adverse event of burning pain in the joints does not meet ICH serious criteria, but is being submitted as an expedited report by special FDA request per 06/28/2000 letter. N 01/01/1999 07/01/2001 912 OTH OTH UNK UNK UNK 20010292091 1
0178410 11/29/2001 IN 0.25 0 .2 F 11/21/2001 Immediately, post vax, infant developed "erythematous blotches" on head, neck, hands and lower legs. PMD's office closed so infant was sent to the hospital. "Fast Track". Y Y 11/05/2001 11/05/2001 0 NONE PUB PUB NONE NONE 1
0178411 11/29/2001 MA 4.0 4 F 11/21/2001 Pt had significant swelling of the arm with warmth and erythema. Left arm circumference 23 1/2cm and right arm circumference 19cm. Redness over most of upper right arm 18cm X 14cm in size. Y Y 11/19/2001 11/20/2001 1 NONE PVT PUB NONE 1
0178412 11/29/2001 WV 79.0 79 M 11/28/2001 The day after receiving vax, pt developed an erythematous, swollen, painful arm. He was prescribed warm compresses and elevation. Y 11/26/2001 11/26/2001 0 NONE PVT PVT Cardura, Prilosec NONE Allergy to penicillin, degenerative joint disease, peptic ulcer disease, benign prostatic hypertrophy, bradycardia 1
0178413 11/29/2001 WV 76.0 76 F 11/28/2001 Pt complained of swollen and painful arm. Prescribed Benadryl by on-call MD. Improved by AM of 11/21/01. Y 11/20/2001 11/20/2001 0 NONE PVT PVT Levoxyl; Norvasc; Lasix; Lanoxin; Lopressor ASA NONE Diabetes mellitus type II; hypertension; episodic atrial fibrillation 1
0178414 11/29/2001 MO 3.0 3 F 11/19/2001 Rec'd varicella 9/20 - 10 days later 9/30 pt broke out with spots on her stomach (looked like red dots above the skin. 10/7/01 red dots faded, but blotches appeared under the skin on her arms, 10/10/01 vomited for 24 hrs, 10/19/01 fever 101F,11/20/01 was seen by physician at Clinic with rash on arms and legs diagnosed with UTI, Rx Amoxil 250/5cc. 10/22/01 seen at Clinic fever for 3 days with hives. Complained of leg pains. 10/23/-10/30/01 child continued to have rash. Worse in groin and buttocks area. Skin peeled from area. 10/30/01 rash and leg pain continued. Seen at clinic pt's calves and legs looked like purpura. Grandmother made appointment with Dr for 11/8/01. Between 10/30-11/08/01 pt continued with leg pain, rashes and skin peeling, 11/8 saw Dr, rash continued on back of legs. Dr performed a multitude of blood tests. All test came back negative except for ANA (Rheumatoid/Purpura. Referred pt to a rheumatologist. 11/19/01 saw Rheumatologist. Skin continued to peel (hands and feet). Rash gone but skin dry and looks like eczema, Dr said looks like some kind of reaction. Prescribed hydrocortisone cream. Y N 09/20/2001 09/30/2001 10 Multitude of test of blood tests done, all came back negative except for ANA (rheumatoid/pupura) PVT PUB None NONE NONE MO2001060 1
0178415 11/29/2001 MA 1.3 1 .2 F 11/16/2001 Received MMR on 11/16/2001. return to clinic on 11/19/2001 complained of rash for one week on upper extremities. Treated with Benadryl. On 11/14/2001 called AM RN, mild fever 100, took Tylenol, see on clinic at same day 2 PM with fever 101, had seizure in clinic around 2:20 PM, pt also decreased response. Y Y 11/06/2001 11/13/2001 7 Febrile seizure. All lab wnl. PUB PUB NONE NONE NONE 1
0178416 11/29/2001 IN 1.25 1 .3 F 11/23/2001 Ataxic event lasting 30 minutes 10 days following vaccine. Developed fever and rash. Now (11/23/2001) doing well. Y Y 11/12/2001 11/22/2001 10 WBC 7.8, Hgb 12.7, Platlets 265, Na 133, K 4.2, CL 102, CO2 23, Glucose 104 and BUN 12. PVT PVT Rhinorhea 1
0178417 11/30/2001 MA 0 .5 F 11/28/2001 A physician reported that her 6 month old granddaughter received Prevnar in 11/01. Two weeks, post vax, on 11/7/01, the infant developed an "elevated white count (22,000)". She was treated in the ER with IV fluids. No additional information was available as of the date of this report. This case was considered serious since the event of an elevated white blood cell count was considered "Medically Important" in this case. Y U 11/01/2001 11/17/2001 16 11/01 WBC-22,000 OTH OTH UNK UNK UNK HQ8829527NOV2001 1
0178419 11/30/2001 M 11/26/2001 It was reported that a male pt who was HIV (+) was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. The pt was also receiving monthly injections of IM, immune serum globulin. Subsequently, the pt experienced vaccine failure and approx. 1 year, post vax, he presented to the hospital with pneumococcal bacteremia. On the basis of a review of blood culture logs at the hospital microbiology lab and of the infectious disease service consultation log between 5/89 and 3/91, it was noted that the clinical course and serotype-specific functional humoral response to S. pneumoniae in 16 HIV-infected pts with pneumococcal bacteremia, and that there was no history of either pneumococcal infection or immunization in any of the 13 pts. No details about the serotype of the organism and immune status of the host were provided. It was noted that sera obtained from HIV (-) adults vaccinated with a 23-valent vaccine showed increased in vitro killing activity against certain S. pneumoniae isotypes when compared with the sera of HIV (+) pts with actual pneumococcal infections. It was noted that although serologic dx may be unreliable in HIV-infected persons, no pt tested showed serologic evidence of recent viral infection. In conclusion, the findings suggested that the high rates of cells and impaired humoral responses to S. pneumoniae rather than to increased exposure to the organism. The report did not state the outcome of the pt's experience. No further information is available. Y Y U Diagnostic lab-pneumococcal antibodies-neg OTH OTH Immune globulin UNK HIV (+); Bacterial pneumonia WAES01110694 1
0178420 11/30/2001 CA 36.0 36 M 11/26/2001 Information has been received from a physician concerning a pt who was vaccinated with varicella virus vaccine live. Subsequently, 30 seconds after receiving the vaccination the pt developed a seizure. The pt had been up all night prior and had drunk large quantities of coffee. the pt was taken by ambulance to an ER but it was unknown if the pt was admitted to the hospital. Upon internal review, seizure was considered to be an other important medical event. Additional information has been requested. Y U 11/16/2001 11/16/2001 0 PVT PVT UNK UNK WAES01112631 1
0178429 11/30/2001 1.4 1 .3 M 11/28/2001 The child received his 4th injection of Infanrix on 10/7/99. On 11/24/99, 48 days post vax, he reportedly experienced an upper respiratory tract infection. His mother reported that he stopped sleeping at night and became very restless. He then "regressed into autism". As of 11/15/01, the autism was ongoing. Outcome of the upper respiratory tract infection was not specified. This report of autism is considered "medically Serious". The mother reported that the pt received Infanrix from lot DTPA9909AZ; however, this is not a valid not number. N 10/07/1999 11/24/1999 48 OTH OTH 20010282281 1
0178434 11/30/2001 NY 26.0 26 F 11/26/2001 The patient experienced redness, warm to touch and slight swelling at the vaccine site in an area approximately 2 1/4" x 1 1/2" approximately 30 hours. Y 11/23/2001 11/25/2001 2 NONE OTH PVT NONE NONE NONE 1
0178435 11/30/2001 NY 49.0 49 F 11/26/2001 Redness, warm to touch, slight swelling under vaccine site approximately 5"x2". No fever approximately 24 hours within injection. Y 11/23/2001 11/24/2001 1 OTH PVT NONE NONE NONE 1
0178436 11/30/2001 MI 13.0 13 M 11/21/2001 Left arm swelling, pain and heat at injection site. Fever. Some better today recovery. Y Y 11/20/2001 11/20/2001 0 PVT UNK Allergies, Asthma, ADD. 1
0178437 11/30/2001 KS 1.75 3 M 11/26/2001 Large swelling and redness left detoid. Pt complains of discomfort. Not using arm as well as usual. Y U 11/20/2001 11/20/2001 0 NONE PUB OTH NONE 11/21/2001 seen, Diagnosis: Otitis NONE KY2001088 1
0178438 11/30/2001 KY 47.0 47 F 11/13/2001 About 1 hours after shot given, arm started (aching whole arm) and up into neck, site of where shot was given, was red and hard knot (2-3 inches) arm and neck ached all day Saturday, seemed somewhat better, but still had large, red, knot. Accidently rubbed arm against clothes dryer and arm, neck, and back around left shoulder blade started hurting like a stiff neck, used icy hot and heating pad on back and neck helped a little. Neck, back and arm are still hurting today, but a little better. N 11/09/2001 11/09/2001 0 PVT UNK Arinzide, 4-Dur 20 mg, Prenarn 12.5, Multivitamin, Calcium 1,000 mg/day Hypertension KY2001089 1
0178439 11/30/2001 IA 49.0 49 M 11/28/2001 Fever, sweating, fast heart beat dizziness. Y 11/27/2001 11/27/2001 0 PUB PVT NONE Allergies to dust and mold see 7~Influenza (Seasonal) (no brand name)~~49.00~In Patient 1
0178440 11/30/2001 NY 71.0 71 M 11/26/2001 Soreness of immunization site within 1/2 hour after injection. Pt reports inability to move arm next day. Swelling of entire arm and hand. Y Y 11/15/2001 11/15/2001 0 PUB PVT NONE 1
0178441 11/30/2001 MO 34.0 34 F 11/26/2001 The patient started on 11/07 with a fever and headache which progressed over 9 days with malaise, hives, itching, fever up to 102F, body aches and coughing up to 9 days after the vaccine. Y U 11/07/2001 11/07/2001 0 NONE PUB PVT NONE NONE Ileostomy, ulcerative colitis and allergic to sulfa and tetracycline. 1
0178442 11/30/2001 VT 48.0 49 F 11/05/2001 The patient felt pain after the injection and had to lie down. It was several days until the whole body pain went away. Y 10/03/2001 10/03/2001 0 NONE PUB PVT NONE 1
0178443 11/30/2001 VT U The patient had generalized pain, cramps, abdominal pain and dizziness for about 2 weeks. Y 10/03/2001 10/03/2001 0 NONE PUB UNK 1
0178444 11/30/2001 VT F 11/21/2001 Post vax the patient's ears started popping, she felt dizzy, her equilibrium was off all weekend, middle ear was stuffed and she had pressure in the head areas. Y 10/14/2001 10/15/2001 1 PUB UNK 1
0178445 11/30/2001 MD 55.0 55 F 11/27/2001 Post vax the patient stated the left deltoid was itching and red. The patient was treated with Benadryl. The patient also complained of tightness in her throat, a rash and shortness of breath. The patient became anxious, stated she needs air and wheezing started. The patient was treated with Albuterol Nebulizer. The patient's coughing decreased with the nebulizer treatment. The patient's chest and back were itching. The patient experienced hives on her neck and chest. The wheezing cleared and the patient's throat was dry. Y Y 11/06/2001 11/06/2001 0 PVT UNK 1
0178446 11/30/2001 AL 1.0 1 .0 F 11/19/2001 The patient developed a maculo-papular rash on her face 30 minutes after her Prevnar injection. The patient was treated with Varivax, comvax, and Atarax. The patient was treated with Atarax. T Y 11/14/2001 11/14/2001 0 NONE PVT OTH AL0115 1
0178447 11/30/2001 IN 0.3 0 .3 F 11/29/2001 Inconsolable crying lasting over 3 hours, within 48 hours of vaccines. Y 11/28/2001 11/28/2001 0 PVT PUB NONE NONE NONE 1
0178448 11/30/2001 IN 0.08 0 .1 M 11/29/2001 Inconsolable crying within 48 hours of vaccine, lasting over 3 hours. Y 11/27/2001 11/28/2001 1 PVT PUB NONE NONE NONE 1
0178449 11/30/2001 IN 0.5 0 .6 F 11/29/2001 Inconsolable crying starting several hours after vaccines. Lasting more than 3 hours. 11/27/2001 11/27/2001 0 PVT PUB NONE NONE NONE 1
0178450 11/30/2001 IN 0.2 0 .2 F 11/29/2001 Inconsolable crying, starting hours after vaccines, lasting over 3 hours. Y Y 11/28/2001 11/28/2001 0 PVT PUB Amoxicillin Upper respiratory infection 1
0178451 11/30/2001 TX 1.7 1 .6 M 11/16/2001 Urticaria-type rash on trunk, neck and cheeks. No wheezes or angioedema. Benadryl was given. Y 11/15/2001 11/15/2001 0 NONE PVT PUB NONE NONE NONE 1
0178452 11/30/2001 MD 50.0 48 M 11/28/2001 The vaccine was administered in May 1999, August 1999 and May 2000. Initial pain in hips started in November 1999 and then progressed to elbows, knees, right hand. Various doctors, Celebrex and now Vioxx, plus pain pills. Hip replacement scheduled for 12/20/2001. A follow up report received 1/28/2002 adds: Left hip replaced on 12/20/2001-righth hip will also be replaced. Cartilege in both hips destroyed in 2 years since taking vaccine. Pain is terrible. Y Y N 05/17/1999 11/01/1999 168 PVT PVT Courmadin, Vioxx and Zestrial. Heart valve replacement in 1990 Penicillin, congenital aortic valve defect 1
0178453 11/30/2001 RI 49.0 46 F 11/20/2001 After having my third shot of Lymerix vaccine, I developed severe pain in my left knee, 6 weeks later it was in my right knee. It is also now located in my right hip and the top my spine in the back of my neck. PCP and orthopedic surgeon visits. Y N 05/25/1999 12/01/2000 556 PVT OTH NONE NONE 1
0178454 11/30/2001 OH 16.0 16 M 11/21/2001 Mother reported to PHN on 11/19/2001 that pt developed pain in scrotal-testicle area approximately 2 weeks after MMR given. Was seen by private MD and diagnosis made of "epididymitis". Mother reported MD did not fell this episode of epididymitis and MMR was related. Approximately 1 week later, pt developed "severe" joint pain and has been seen by several physicians. Presently being treated by MD at Hospital. Mother reported that pt has had blood work done, multiple appointments and presently receiving therapy and treatment due to continued joint pain. Was encouraged to complete adverse event report or call the 1-800 number. Y U 09/12/2001 09/26/2001 14 Blood work PUB UNK NONE NONE NONE 1
0178455 11/30/2001 CT 8.0 3 F 11/27/2001 Fevers with slight itchy rash on trunk, arms, face and scalp. Y 01/04/1997 11/24/2001 1785 NONE PVT PVT NONE NONE 1
0178456 11/30/2001 SC 11.0 11 F 11/21/2001 Mother called to report hives approximately 2 hours after Hepatitis B #1 given at Health Department. Seen by MD. Hives on neck, underarms, back and stomach. Treatment: Benadryl by MD. He signed a medical contraindication for no further Hepatitis B shots. Y Y 08/06/2001 08/06/2001 0 NONE PUB PUB Singulair, Rhinocourt, Adavair, MDI and Albuterol. NONE Asthma and Allergies: Mold, trees, grasses, fish, dust and pollen. SC0158 1
0178457 11/30/2001 CA 27.0 27 F 11/23/2001 Female pt, unknowingly pregnant (missed menses by 14 days), was administered MMR vaccine on 12-NOV-2001. Referred to OB and Fetal Assessment Unit for follow up. Y 11/12/2001 11/14/2001 Rubella titer-immune, Mumps Virus AB-positive, Urine HCG-positive MIL MIL UNK NONE UNK 1
0178458 11/30/2001 TX 42.0 42 F 10/08/2001 Approximately 20 minutes after injection, felt faint, had "tunnel vision", face got hot; rapid pulse. Started feeling better in one hour, but felt "drained" all day. Following day, temp 99.9 (oral), on 10/07/2001, temp 98. Did not go to ER or contact Dr. Y 10/08/2001 10/08/2001 0 NONE PUB UNK Allegra NONE Allergic to Penicillin passed out~Vaccine not specified (no brand name)~~0.00~In Patient TX01176 1
0178459 12/03/2001 WY 0 .0 M 11/27/2001 Information has been received from an RN concerning a 6 day old male relative who on 11/6/01 was vaccinated with Hep-B vaccine recombinant (yeast). On 11/10/01, the child died. The cause of death was unknown. Autopsy report states child's age at time of death to be 18 days old. Cause of death is traumatic compression of head and chest due to overlaying, manner of death accidental. Y 11/10/2001 Y N 11/06/2001 11/10/2001 4 UNK UNK UNK UNK WAES01111393 1
0178460 12/03/2001 SC 1.0 1 .0 F 02/12/2002 On 8/9/00, pt was vaccinated with the first dose of varicella virus vaccine live, third dose of hepatitis b vaccine recombinant, the first dose of streptococcus pneumoniae vaccine and the third dose of poliovirus vaccine. On the day of receiving vax, the pt experienced a local reaction on leg with a knot. Pt received treatment with Benadryl. Seven days post vax, pt developed a fever that lasted for 5 days or longer and then resolved. Since the vax, every 3-4 weeks, the pt developed a fever up to 105. At times, the pt develops a seizure from the fever. It was reported that in September 2001, pt did not develop a fever but did develop a genital rash (also reported as genital ulcers). Pt was referred to a dermatologist on 9/12/01. Dermatologist stated that the lesions were more accurately described as blisters and were confined to the vulva area. The pt has experienced some scarring from the blisters. The genital rash was described by the pt's mother as "looks like the chicken pox rash." The doctors are unsure, but they say that the pt has a type of syndrome in which she develops fevers. A culture of the lesions was performed for herpes simplex which was negative, but the dermatologist stated that it may not have been a good culture since it was not obtained at a time of "big flare." If the rash recurs, another culture will be obtained. A pediatric infectious disease MD felt the pt may have "recurrent fever aphthous ulcers" which can reportedly occur in the genital area. The dermatologist or pediatric infectious disease MD can confirm an etiology for the rash. Follow-up info from the pt's mother indicated that the pt has possible "PFAPA" (Periodic Fever, Aphthous Stomatitis, Pharyngitis, and Adenitis Syndrome). The pt was treated with Tagamet. It was noted that the fever was ongoing. The mother reported that the pt required medical intervention to prevent a serious outcome, and therefore, the events were considered to be other important medical events. Addtl info has been requested. Follow up info from a physician noted that since discussing the possibility of a vaccine, it was felt that the pt had FFAPA syndrome or periodic fever, apthous stomatitis, pharyngitis, adenopathy. The physician noted "she has not had an episode that I can culture and at this point I would like to comment that I do not think it is related and therefore we will not be following up with this." It was also noted that the pt reportedly developed a febrile seizure, pharyngitis, lymphadenopathy, rash vesicular bullous, mouth ulceration and vulvovaginal disorder. No further info is available. Y N 08/09/2000 08/09/2000 0 Herpes simplex virus-neg PVT PVT Galactosemia WAES01092362 1
0178462 12/03/2001 AZ 57.0 57 F 01/22/2002 Information has been received from a nurse concerning a 57 year old female hospital employee who on 10/12/01 was vaccinated with varicella virus vaccine live. On 10/27/01, the pt developed a continuous fever that ran between 100.3F and 100.5F. On 10/29/01, the pt broke out with 3 chickenpox vesicles which were described as red spots that elevated to a vesicular, itchy rash that erupted and crusted. On 11/13/01, following treatment with ibuprofen (Advil), the pt's fever spiked to 102F. The pt was subsequently, hospitalized for the events and was treated with ibuprofen (Advil), acyclovir and hydroxyzine hydrochloride (Atarax). It was reported that the pt was found to have a non-skin abscess which was being surgically addressed. It was also reported that the pt had total of approx. 12 vesicles which at the time of this report, were resolving. At the time of this report, the pt was still experiencing a low-grade fever. Additional information has been requested. The follow up states that on 11/10/01, the pt ws still febrile, therefore blood work and a chest x-ray were taken. The pt was found to have an elevated white blood cell count and an abnormal ESr however all other diagnostic studies were noted to be normal. The chest x-ray was also reported as normal. On 11/13/01, following treatment with Advil, the pt's fever spiked to 102 deg F. The pt was subsequently hospitalized on 11/14/01 for the events and was treated with Advil, acylcovir, and have a large abdominal abscess which was surgically drained. The pt was hospitalzied for 8+ days and by 12/16/01 had recovered from all of the events. The pt's internist felt that the abdominal abscess was probably not related to varicella virus vaccine live. The reporter felt that the events were important for an other medical event (OMIC). No further info is expected. Y Y Y 10/12/2001 10/26/2001 14 CXR-nml; Lab-nml; Erythrocyte-abn; Lab-Varicella antibody screen-neg; Temperature measurement-100.3F to 100.5F and then 102F; WBC count-elevated PVT PVT UNK Asthma, hypertension WAES01111705 1
0178466 12/03/2001 NJ 1.75 0 .8 M 11/29/2001 Pt recvd Engerix-B on 5/10/95, 6/26/95, and 1/25/96. He also recvd DPT (Lederle Labs) on 6/26/95, 8/22/95, 10/26/95, 1/25/96 and 10/28/96. He recvd HIB (Lederle Labs) 6/26/95, 8/22/95, 10/26/95 and 10/28/96. He received oral poliomyelitis vaccine (Lederle Labs) 6/26/95, 8/22/95, and 10/28/96. He recvd MMR (Merck) 7/25/96 and varicella virus vax (Merck) 4/29/96. The pt's attorney alleged that "shortly before his 21-month check-up, pt began to display symptoms of neurological damage consistent with mercury poisoning. The symptoms included, without limitation, regression of his language skills, engaging in repetitive behaviors, suffering from diminished cognitive ability, and becoming socially withdrawn. Pt received and is still receiving medical treatment in an effort to remove mercury from his body. As mercury levels in his body have decreased, the plaintiffs have noted modest improvement in symptoms." The attorney alleged that each symptoms was severe in intensity. The attorney also alleged that each dose of every vaccine administered was the source of the mercury. This report of mercury poisoning is considered GSK medically serious. Y N 01/25/1996 01/01/1997 342 OTH OTH 20010282491 1
0178467 12/03/2001 IL 41.0 42 F 01/03/2002 A 41 year old female consumer reported that she received Influenza virus vaccine, Trivalent, Types A and B (2001-2002 formula) (manufacturer unknown) on 23-OCT-2001. Concomitant medication included Zestoctic (manufacturer unknown). On 08-NOV-2001, she developed numbness in her toes and finger, the middle of her back and the tip of her tongue. She also experienced "excruciating" pain. On 23-NOV-2001, she was hospitalized. Laboratory tests included EMG, MRI and spinal taps (results not reported). The reporter noted that Guillian Barre was ruled out. On 27-NOV-2001, she was discharged without a diagnosis. She is scheduled to see a Neurologist. No additional information was available as of the date of this report. Follow up info received 12/31/01. Lab test results were reported. Nuclear magnetic resonance imaging results reported aas "lesion in T-spinal cord." Lumbar puncture results reported increased protein. Electromyogram results were "consistent with peripheral neuropathy." Y Y 4 U 10/23/2001 11/08/2001 16 Laboratory tests included EMG, MRI and spinal taps (results not reported). Nuclear magnetic resonance imaging results reported aas "lesion in T-spinal cord." Lumbar puncture results reported increased protein. Electromyogram results were "consistent with peripheral neuropathy." PVT OTH Zesrorectic "Zeneca" NONE High blood pressure HQ8967629NOV2001 1
0178469 12/03/2001 PA 20.0 20 F 11/28/2001 Information has been received from a pharmacist concerning a 20 year old female who on 4/9/01 was vaccinated with rubella virus vaccine live (second generation). Subsequently, the pt developed an immediate reaction with lips swelling, tightening of the airway and eyes swelling. The pt was given 25mg diphenhydramine hydrochloride (Benadryl), Im, and then 50mg IM. It was noted that the pulse oximeter check and respirations were "good". Upon internal review, the event was determined to be an "Other Important Medical Event". Additional information has been requested. Y 04/09/2001 04/09/2001 0 It was noted that the pulse oximeter check and respirations were "good". OTH OTH Motrin; magnesia (milk of); Compazine PCN Allergy WAES01040938 1
0178470 12/03/2001 CA 70.0 71 M 11/29/2001 Pt developed body aches, chills, sore throat and increasing difficulty swallowing with swelling of lip, 1 day after receiving influenza vaccine injection and about 8 weeks after beginning Allopurinol (history of receiving influenza vaccine yearly without reaction; Allopurinol initially 100mg OD but increased to 300mg several weeks later). Pt had 80% to 90% body surface area sloughing (Toxic Epidermal Necrolysis). Admitted to the hospital, 1 day after development of above mentioned signs and symptoms; allopurinol discontinued and treated with antibiotics and steroids. After 16 days in the hospital, he was transferred to another hospital service where steroids were discontinued; treated with IVIG, silver nitrate topical. Wounds continued to slough and pt expired on 5th hospital day. Y 11/09/2001 Y N 11/04/2001 11/05/2001 1 UNK UNK Allopurinol; benazepril; burnetanide; KCI; simvastatin; warfarin; colchicine; prenatal vitamins; epoetin alpha; pamidronate; metolazone; insulin Multiple myeloma; Rheumatic heart disease with mechanical valve; Gout; DM; HTN; decreased renal function and Obesity 1
0178471 12/03/2001 NY 1.0 1 .0 M 11/27/2001 On 5/15/2001 (1 year well visit) received Varivax. On 05/23/2001 developed grand mal seizure activity and brought to ER. Had 1 episode of diarrhea on 05/22/2001, was "fussy" on 05/23/2001 and tactile fever (not documented) developed seizures. Treated with IV valium, afivar then when seizre ended transferred to Medical Center. Y Y Y 05/15/2001 05/23/2001 8 EEG/MIR; Spinal Tap-all nml PVT PVT NONE NONE 1
0178472 12/03/2001 RI 2.0 1 .2 M 11/27/2001 Pt had a positive Streptococcus Pneumoniae on 11/9/01. Pt had received 2 prior doses of Prevnar on 7/11/00 and 9/9/001. Y 3 Y 09/09/2000 11/09/2001 426 Pedi Blood Culture-(+) for Strep Pneumonia PVT UNK NONE Chronic lung disease 1
0178473 12/03/2001 NJ 37.0 37 F 11/26/2001 Pt went into A-Fibrillation. EMT's could not regulate, therefore, ambulance took pt to ER. Y Y 4 Y 10/22/2001 10/26/2001 4 EKG; Echocardiogram-neg; Blood sugar-raised to diabetic lever when admitted; BP-raised PVT OTH Ortho-Novum 777; Claritin-D/Serevent Paxil, Wellbutrin NONE Asthma; Allergy to pollen/dust and mold 1
0178474 12/03/2001 VA 0.4 0 .4 M 11/09/2001 Determined to be paralytic polio as of 10/23/01 by a panel of national experts outside the CDC. Y Y Y Y 05/15/1997 07/10/1998 421 On 7/10/98, stool specimen sent to urology for polio viral study PVT OTH A-gamma globulinemia VA01032 1
0178475 12/03/2001 CA 44.0 42 M 11/27/2001 About 1 week, post vax, pt developed recurrent a rash on his back and a flu-like illness for 1 month afterwards. U 12/10/1999 12/17/1999 7 PVT PVT NONE NONE NONE 1
0178476 12/03/2001 MA 53.0 53 M 11/30/2001 Shot at 10:30 AM on 11/29/2001. One hour: blurry vision, numbness in both arms and hands. Weak leg (left). At 2 PM blotchy, trembling hands. Joint aches. Headache. Twenty-seven hours later, left wrist and fingers numb, burning and painful. N 11/29/2001 11/29/2001 0 OTH UNK Hytrin 2.0 mg and Prilosec Sulfa drugs (rash) 1
0178477 12/03/2001 MA 55.0 54 F 11/20/2001 Flu immunization given on 10/29/01. The following day, pt discovered a rash and 1 day later, this rash covered her entire body. Allergic reaction to Flu vaccine. U 10/29/2001 10/31/2001 2 OTH OTH Allergy to Penicillin 1
0178478 12/03/2001 VT F 11/21/2001 The pt developed pain at the injection site, initially on 10/19/01, and the pain worsened. It went up the neck and down arms to chest and down hands to 4th and 5th digits which was prickly. Cannot move right arm. Seen MD and the flu vaccine could not be ruled out. It may be related. Y 10/10/2001 10/17/2001 7 PUB OTH 1
0178479 12/03/2001 SC 69.0 69 F 11/20/2001 Local reaction Y 10/09/2001 10/12/2001 3 NONE PVT UNK MVI, Lovazepam, Elotris, Trimethoprim, Mevacor, Zantac Toprol Nitorpatch, Premarin, Urecholine, Paraton forte, Ultram, Lactulose, Celebrex and Bumex NONE Sulfa, morphine and Benadryl 1
0178480 12/03/2001 VA 50.0 50 F 11/28/2001 About 2.5 hours after immunization client developed hives over arm, legs and trunk with itching. No other symptoms. Has taken flu shots "for years". N 11/27/2001 11/27/2001 0 NONE PUB OTH Zyrtec, Diabeta and Glucophage NONE Diabetes 1
0178481 12/03/2001 TX 60.0 60 F 11/21/2001 Extreme swelling of left arm. Flu symptoms within 2 to 3 hours and fever. Red rash on left arm. Very ill with drainage, congestion, cough, sore throat, finally saw MD who gave Zpak. Y 10/22/2001 10/22/2001 0 MD said URI one week after onset of above symptoms. OTH OTH Zocor, Cazoor, Norvasc, Depakote, Zoloft and Melaril NONE High blood pressure; treatment for depression. 1
0178482 12/03/2001 MD 53.0 53 F 11/08/2001 Day 1: after injection itching. Day 2: wheals, rash over left upper and lower arm, intense itching. Y Y 11/06/2001 11/07/2001 1 PUB UNK Claritin 10 mg 1 tablet for 7 days. Cortisone cream topically BID. Triantherene NONE High blood pressure VA01035 1
0178483 12/03/2001 VA 75.0 75 M 11/15/2001 Bleeding from roof of mouth starting 11/13/2001. Is on Coumadin daily. MD told pt that flu vaccine elevated PTT and INR. Y Y 11/08/2001 11/13/2001 5 PTT and INT drawn 11/13/2001 and 11/15/2001. PUB PUB Coumadin and Alpha-Beta blocker NONE Pacemaker, borderline renal failure, CVA VA01033 1
0178484 12/03/2001 NY 60.0 60 F 11/21/2001 Pt's right arm was hot to touch and very sore shoulder and arm. She had several red, blotchy areas and spreading. Y U 11/19/2001 11/20/2001 1 PVT OTH Sinus congestion GERD; DJD; Allergies/sinus; High cholesterol; Depression; Cardiac Catheter at age of 38. 1
0178485 12/03/2001 UT 76.0 76 M 11/26/2001 Pt began experiencing pain at the injection site, a few days after immunization. His whole arm has been throbbing and the pain is not relieved by any medications that he has taken. N 11/01/2001 OTH PVT 1
0178486 12/03/2001 NC 57.0 57 F 11/26/2001 Area of injection was red and swollen 35mm X 55mm. Y 11/19/2001 11/20/2001 1 PUB PVT NONE 1
0178487 12/03/2001 VA 30.0 30 F 11/26/2001 Received vaccine at 2:30 PM. Symptoms began 6 PM that day, stomachache, vomiting, temp 101.3, muscle and back ache, swollen left eye, redness, asthma-had to go to PMD for asthma treatment. Recovery took 5 days. Return to work 11/12/2001. Pt had had her first flu shot last year. Y Y 11/06/2001 11/06/2001 0 NONE OTH OTH Albuterol NONE Asthma 1
0178488 12/03/2001 VA 1.5 1 .5 M 11/26/2001 Pt received all Prevnar doses. Had streptpneumonia bacteremia on 11/13/2001 with fever and increased WBC 36,000. Treated outpatient with Rocephin. Had bronchitis one week prior, was resolving. Y Y 11/13/2001 11/13/2001 0 Blood culture=Streptpneumonia. WBC=36,000 PVT PVT 1
0178489 12/03/2001 CO 1.0 M 11/18/2001 Pt received Prevnar, DTaP and MMR. He ran fever up to 104.3 in the ten days following vaccines with out other apparent source for fever. Finally resolved without sequelae with only supportive treatment. We discovered when he was back for 15 month exam that the lot number our then CFNP recorded from the Prevnar was actually a lot number for Pneumovax. I believe she incorrectly gave Pneumovax, not Prevnar. Pt is now well. Y 08/06/2001 08/06/2001 0 WBC=19,400 about one week after injections UNK UNK NONE 1
0178490 12/03/2001 PA 1.25 0 1 M 11/26/2001 Severe reaction. T greater than 104. Vomited 20 times in 18 hours. Began 8-12 hours post injection. Pt just notified us 11/26/2001 on her 15 month visit. Y 08/04/2001 08/04/2001 0 NONE PVT PVT Zantac and reglan NONE GER 1
0178491 12/03/2001 PA 50.0 50 M 11/23/2001 Paralysis of right upper extremity for 1-2 days after vaccine given and rash on chest wall. Rash persistent 3 days after vaccine given. Y 11/20/2001 11/20/2001 0 PVT PVT Hytrim, Prinil, Glucopgae and Starlix NONE History of CMV 1/01 with encephalypathy, Hypertension and Diabetes mellitus. 1
0178492 12/03/2001 KS 1.08 1 .1 F 11/26/2001 Fever 101.4 on 11/04/2001. Rash started 11/05/2001. Macular rash, no symptoms of itching; rash generalized; palms and sides spared. 11/06/2001 Seen in office, generalized rash, markedly erythmatous. 11/07/2001 Rash began to fading and resolving. Y 10/25/2001 11/05/2001 11 11/06/2001 CBC-WBC 5.1; Hgb 10.1; HCT 30-4; PLT 232. Measles IgG, IgM not detected. PVT PVT NONE NONE 1
0178493 12/03/2001 WV F 11/27/2001 Rash for 5 days, itching, blisters, then scabs. 8-10 lesions. Y 11/01/1996 11/21/2001 1846 OTH OTH 1
0178494 12/03/2001 MS 17.0 17 F 11/26/2001 Returned for 2nd varicella. First given 10/23/2001. "I had to go to MD a few days later my arm got big. I ashed all over my back and legs hurt a lot. He gave me Benadryl." Y Y 10/23/2001 10/28/2001 5 PUB PUB Ortho Tricyclen NONE NONE MS01051 1
0178495 12/03/2001 MD 27.0 27 F 11/27/2001 Pt report on 11/14/01: "dizzy, warm, dehydrated" shortly after shot x 2 1/2 hrs; then (same day @ 8pm): so dizzy couldn't stand, nausea times 1 hr. Pt report on 11/15/01: dizzy today times 2 hrs also had previous episode of dizziness 3 mos prior. Had appt to see MD, but did not. Pt report on 11/21/01: "6 bumps under skin" noted 11/15/01 @ injection site; pruritic, never vesicular. Dizziness times 4-5 hrs. Y 11/02/2001 11/02/2001 0 PUB PUB 1
0178496 12/03/2001 PA 6.0 1 .1 M 11/26/2001 Began 11/21/2001 afternoon with T 100.4, abdominal pain and red, raised vesicles. Capules, scrbs 22 for limited to torso mildly pruritic. Y 02/27/1996 11/21/2001 2094 NONE PVT PVT Tine Connaught Mild URI Milk, chocolate and seasonal 1
0178497 12/03/2001 PA 8.0 2 .2 M 11/26/2001 Fever x 24 hrs on 11/19/01 with 15 pox widely scattered on body (back, abdomen, legs. Y 12/17/1995 11/19/2001 2164 NONE PVT PVT NONE NONE NONE 1
0178498 12/03/2001 AZ 4.8 4 M 11/20/2001 One cm slightly tender erythematous, indurated subcutaneous area with control crust in the left arm site of Varivax injection. Treated with Benadryl chewable q 4 hours PRN and steroid topical cream daily PRN. Y 11/06/2001 11/19/2001 13 PVT PVT NONE NONE NONE 1
0178499 12/03/2001 WI 1.2 1 .1 M 11/23/2001 11/12/01 spoke with mother states 10 days after pt had rec'd the vaccines, he developed one walnut size bump on R cheek & also a walnut sized lump on R thigh. today the 19th she has noted that they are starting to go away. They are red in color."they do not bother him" she states. Contacted walk-in clinic & the pediatrician. Both did not feel it warranted a medical visit because he did not experience a fever with the bumps. Y 11/07/2001 11/16/2001 9 NONE PUB PUB NONE NO unknown allergy to eggs, has not had any eggs yet. 1
0178500 12/03/2001 OH F 11/26/2001 Flu shot given. Approximately 9 minutes later, pt reported, "felt funny, heart racing" BP 174/94, P 126, R 12. Skin warm, dry, pink, ho SOB. At 6:24 AM 160/90-92-12. Nose stuffy, feels better 6:23 AM 134/90-92-12 better 6:32 AM 132/86-80-12. No heart racing, calmer. 6:38 AM 126/82-76-12, okay back to work. 6:46 AM 16/82-124-24 back hurts, racing heart and throat slight tightness. Gave Epi. 0.5cc SQ. Skin cool and dry pt fearful, medic called, arrived 6:53 AM BP 170/100-140 lungs clear. Medic feels reaction is anxiety, leave 7:11 AM. 7:13 AM 140/82-92-12. Pt back to work. 7:40 AM working, no symptoms or complaints. 140/82-88, color pink, skin warm and dry. This was the pt's first time getting a flu shot. Y 11/23/2001 11/23/2001 0 OTH PVT NONE NONE 1
0178501 12/03/2001 TX 26.0 26 F 11/26/2001 Cold chill attack, shaking uncontrollably, headache, muscle soreness all over body. Y 11/05/2001 11/05/2001 0 NONE PUB PUB Ortho Trycyclen 7 qd NONE NONE 1
0178502 12/03/2001 MA 1.08 1 .0 F 11/27/2001 Ten days after vaccine developed fever 100.3 and with papular/macular rash on face and torso, other wise okay. Fever for 2 days. Y 11/08/2001 11/18/2001 10 NONE PVT PUB 1
0178503 12/03/2001 TX 1.08 1 .2 M 11/16/2001 Temperature to 102 night of immunization lasting about 36 hours, mother perceived pain and swelling testicles 48 hours later. Y 11/14/2001 11/14/2001 0 NONE PVT PUB Zithromax started 11/14/2001 Otitis Media NONE 1
0178504 12/03/2001 NE 40.0 40 F 11/23/2001 Two to three days post injection noticed 2 larger red, raised, itchy areas along with 2 smaller areas of the same description. Y 11/06/2001 11/08/2001 2 NONE PVT PVT Pesogen NONE Environmental allergies 1
0178505 12/03/2001 CA 33.0 M 11/28/2001 Information has been rec'd from a NP concerning a 33 year old male with diabetes Mellitus who on 10/20/00 was vaccinated with rubella virus vaccine live (second generation). On 11/01/00, the pt experienced lymphadenopathy and a rash on his entire body. Medical attention was sought. Additional information has been requested. Y U 10/20/2000 11/01/2000 12 OTH OTH UNK (see additional page) no page attached WAES00110171 1
0178506 12/03/2001 NY 31.0 31 F 11/28/2001 Information has been rec'd from a pharmacist concerning a 31 yr old female who on approximately 1/12/01 was vaccinated with rubella virus vaccine live (second generation) Concomitant therapy included ethimyl estradiol/norgestres (Triphasil) Subsequently on approximately 1/12/01 the pt experienced allergic eczema. The pt was placed on therapy with methylprednisolone (Medrol dose pack). In follow-up the physician's office reported that they did not know what this is about and did not report this adverse event. No further information is expected. Y U 01/12/2001 01/12/2001 0 OTH OTH Triphasil UNK WAES01012513 1
0178507 12/03/2001 PA 53.0 53 F 11/28/2001 Information has been received from a health professional concerning a fifty-three year white female with no known drug allergies and no past medical history, who on 02/20/2001 was vaccinated SQ in the arm with a first dose of rubella virus vaccine (second generation0. There was no illness at the time of vaccination. Concomitant therapy included sertraline hcl, estrogens and conjugated (+) medroxyprogesterone acetate. On 03/06/2001, the patient developed joint pain of the hands, knees, wrists and great toes and a mild rash behind her knees and under her arms. Unspecified medical attention was sought. It was reported that on approximately on 03/13/2001, the symptoms started to resolve. Follow up information has been received from a health care professional that states no medical intervention was needed, The symptoms resolved over time. The patient stated on 03/07/2001 or 0308/2001, she began to notice discomfort in her right wrist. Several days later it started in her left wrist. Within a "couple of days", the discomfort (pain when moving joint) began in her knees, toes, ankles and fingers in that order. She reported that her knees resolved the most rapidly. About a week after onset, they were much better. The other joint areas, especially her hands and fingers, remained painful for about two weeks. They finally resolved totally about two weeks after onset. The patient also reported experiencing swelling in her hands and feet that started about two weeks after the injection and persisted for three weeks. It was noted that a tuberculin skin test was performed and that a "pre-placement" rubella screen done on 02/13/2001 showed no immunity. It was also noted that the patient was considered recovered by 03/29/2001. Y Y 02/20/2001 03/06/2001 14 diagnostic laboratory 02/13/01 rubella screen - no immunity tuberculin skin test OTH OTH Premphase, zoloft NONE WAES01031650 1
0178508 12/03/2001 WA U 11/28/2001 Information has been rec'd from a RN from the hlth dept concerning several weird cases where people who in approximately 1968 were vaccinated with mono valent measles vaccine are presently exhibiting measles - type symptoms. The nsg stated that she felt this was not measles, but something else. Unspecified medical attention was sought. Follow up information from the nsg indicated that one individual rec'd a mono valent measles vaccine Manufacturer unknown (lot # 6142221330B) in approximately 1968. It was noted that lot # 6142221330B corresponds with rubella virus vaccine live (meruvax II) that was released for sale on Nov 6,1995 and expired Sept 5, 97. She reported that she was not sure of the date of vaccination and could not explain how the pt got a vaccine in 1968 that was not released until 1995. She stated that the pt developed a rash on approximately mar 26, 2001 that tested negative for measles. The reporter felt that the rash had to be caused by something else and it was not a vaccine reaction. She noted that blood specimens were sent to the CDC for testing and she had not rec'd any results from these test. It was also reported that there were 15 confirmed cases of measles (WAES #01111103) and numerous other rash illnesses that proved not to be measles (WAES #01111104). She was not able to elaborate on these cases. Additional information has been requested. Y U 03/26/2001 diagnostic lab negative for measles OTH OTH UNK UNK 1
0178509 12/03/2001 GA 31.0 31 F 11/28/2001 Information has been received from an LPN concerning a 31 year old female who on 3/23/01 was vaccinated with rubella virus vaccine live (second generation) (lot 638553/1862K). On 4/2/01, laboratory evaluations revealed a "negative titer". Additional information has been requested. Y U 03/23/2001 04/02/2001 10 Diagnostic lab on 4/2/01-neg titer OTH OTH UNK UNK WAES01040671 1
0178511 12/03/2001 FL U Information has been received from a physician's office concerning a 26 year old female who was vaccinated with rubella virus vaccine live (second generation). Subsequently, a titer test was negative. No further information is expected. Y U Serum varicella zoster-positive; lab-positive for measles; lab-negative for rubella OTH OTH UNK UNK WAES01041925 1
0178512 12/03/2001 NY 1.5 1 .5 F 11/28/2001 Information has been received from the mother of an 18 month old female with no known allergies and no past medical history who on 4/12/01 was vaccinated with rubella virus vaccine live (second generation). There was no concomitant medication. On approx. 4/19/01, the pt developed a fever for 2 days. On 4/22/01, the pt developed a rash. The pt's rash persisted as of 4/26/01. Unspecified medical attention was sought. No further details were provided. Additional information has been requested. Y N 04/12/2001 04/19/2001 7 OTH OTH NONE NONE WAES01042655 1
0178513 12/03/2001 OH 56.0 M 11/28/2001 Information has been received from a woman in a physician's office concerning a 56 year old male who was "negative for rubella". On approx. 4/16/01, the pt was vaccinated with rubella virus vaccine live (second generation). On 4/28/01, the pt experienced a maculopapular rash and was afebrile. No additional information was available. Unspecified medical attention was sought. Additional information has been requested. Y U 04/16/2001 04/28/2001 12 Lab-negative rubella titer OTH OTH UNK UNK WAES01050023 1
0178514 12/03/2001 WI 1.75 1 .6 M 11/27/2002 Information has been received from a physician and a health professional concerning the health care professional's 19 month old white son with no known drug allergies and no past medical history who on 7/6/01, at approx. 08:45, was vaccinated with a 1st dose of rubella virus vaccine live (second generation) (lot 630609/0410J). It was noted that the vaccine expired on 3/4/01. There was no concomitant medication. There was no illness at the time of vaccination. One month, post vax, the rubella IgG antibodies were done that were positive. On 7/16/01, the pt experienced a generalized rash over the entire body including the trunk, arms, legs and face. It was reported by the responsible physician that the "rash was unrelated to the shot". The child was afebrile. Unspecified medical attention was sought. Additional information has been requested. Follow up info from the physician indicated that the child was "doing fine" and did not have any ongoing problem related to the vaccination. It was noted that his rubella titers were adequate. Y Y 07/06/2001 07/06/2001 0 Lab test on 8/6/01-(+) for rubella IgG antibodies PVT PVT NONE NONE NONE WAES01070568 1
0178515 12/03/2001 30.0 F 11/28/2001 Information has been received from physician concerning a 30 year old female who on approximately 12JUN2001 was vaccinated was vaccinated with rubella virus vaccine live (second generation). Subsequently, a rubella titer did not show seroconversion. Additional information has been requested. Y 06/12/2001 Rubella titer negative UNK UNK UNK UNK WAES01072413 1
0178516 12/03/2001 PA 49.0 47 F 11/28/2001 Information has been received from a 49 year old female consumer was vaccinated on 09-SEP-1999 with Meruvax II. Concomitant therapy included vitamin E. On approximately 23-OCT-1999 the pt developed joint pain and swelling in her hands. She experienced nodules on her wrists and her elbows swelled to twice the normal size. She had spasm on the tops of her hands and was in severe pain. She was diagnosed by a rheumatologist as having rubella arthritis. her symptoms moved around and into her feet where she experienced severe pain and swelling. For therapy she was also given NSAIDs which she could not tolerate. The pt subsequently experienced nosebleeds while on therapy for 4 days with rofecoxib. She had immune system problems and also liver function problems. It was reported that the symptoms of "pain" have been resolved. Additional information has been requested. Y N 09/09/1999 10/23/1999 44 OTH OTH Vitamin E Antibiotic allergy; PCN allergy WAES01080273 1
0178517 12/03/2001 IL 31.0 31 F 11/28/2001 Information has been received from a physician concerning a 31 year old white female, with no past medical history, no known allergies and no known illness at the time of vaccination, who on 25-JUL-2001 was vaccinated with a first dose of Meruvax II, administered SC, in the left deltoid. There was no known concomitant medication. It was reported that the vaccination was given "pre-pregnancy attempt". On 04-AUG-2001, in the evening, the pt developed a sore throat, rash on the back of her throat, rash on her face and arms and blister on her external nose and ears. On 07-AUG-2001 the pt was seen by a physician and treated with prednisone for 4 days. It was reported that she "feels febrile" but had not monitored her temperature. It was also reported that no laboratory tests were ordered by the primary care physician. Follow up information received 28-SEP-2001, from a RN, indicated that the PCP did not believe that the symptoms were related to vaccination nor to poison ivy. Subsequently the pt recovered. No further information is available. Y Y 07/25/2001 08/04/2001 10 NONE PUB OTH NONE NONE WAES01082796 1
0178518 12/03/2001 33.0 33 F 11/28/2001 Information has been received from a RN on 10-SEP-2001 concerning a 33 year old female with infertility and no allergies who "approximately 7-10 days ago" was vaccinated with a dose of Meruvax II. On 10-SEP-2001 the pt had swollen glands and a low grade fever. the pt sought unspecified medical attention. Additional information has been requested. Y U 08/31/2001 09/10/2001 10 OTH OTH UNK Infertility WAES01091149 1
0178519 12/03/2001 F 11/28/2001 Information has been received on 10-SEP-2001 from a RN concerning an adult female who approximately one year ago was vaccinated with a dose of Meruvax II. Subsequently the pt failed to seroconvert. The pt sought unspecified medical attention. Additional information has been requested. Y U Failed to seroconvert OTH OTH UNK UNK WAES01091161 1
0178520 12/03/2001 U 11/28/2001 Information has been received from a RN from the HD concerning "several weird cases of people who in 1968 were vaccinated with a monovalent measles vaccine and are presently exhibiting measles type symptoms". The nurse stated she did not feel this was measles, but something else. Unspecified medical attention was sought. Follow up information from the RN indicated that there were 15 confirmed cases of measles. The nurse could not elaborate on these cases. She also reported an individual developed a rash after vaccination and other rash illnesses that were not proved to be measles and had no definite diagnosis. Y U 01/01/1968 UNK UNK UNK UNK WAES01111103 1
0178521 12/03/2001 U 11/28/2001 Information has been received from a RN from the HD concerning "several cases of people who in 1968 were vaccinated with a monovalent measles vaccine and are presently exhibiting measles type symptoms". The nurse stated she did not feel this was measles, but something else. Unspecified medical attention was sought. Follow up information from the nurse indicated that there were numerous cases of rah illnesses that proved not to be measles. There was no definitive diagnosis for these cases and she was not able to elaborate. She also reported 15 confirmed cases of measles and one individual developed a rash that tested negative for measles. Additional information has been requested. Y U 01/01/1968 OTH OTH UNK UNK WAES01111104 1
0178522 12/04/2001 LA 0.2 0 .2 M Two-month-old was found by family unresponsive in bed. Family stated pt had his first set of vaccines 7-10 days prior to event. Pt was coded, intubated and CPR was performed, but pt did not respond. Pt was taken to hospital in cardiac arrest. Pt also commonly slept in bed with other family members. COD as per autopsy report was SIDS. Y 09/23/2001 Y N 09/13/2001 09/23/2001 10 OTH OTH 1
0178523 12/04/2001 CT 69.0 69 M 12/03/2001 2 days, post vax, the vaccinee complained of chills, myalgias and shortness of breath. 3 days, post vax, his temperature was 102F; CXR with infiltrate and pulse ox 85%. He was admitted and rx'd with Zithromax, O2 and steroids. CXR and clinical determination to ARDS, mechanical ventilation and death. Autopsy findings state cardiomegaly and left and right ventricular hypertrophy; focally calcified mitral valve. Secondary findings: ascites. Y 11/17/2001 Y N 10/25/2001 10/27/2001 2 Bronchoscopy; open lung biopsy; CXR-infiltration PVT PVT Prednisone 20 mg BID times 3 weeks. Discontinued same day. Pulmonary fibrosis 1
0178524 12/04/2001 PA 44.0 44 M 12/18/2001 It was reported by the pt that he, a 44 year old male, received a Fluzone '01-'02 vaccination on 10/26/01. The pt developed double vision on 10/28/01; the double vision is still persisting. Pt also experienced tingling in hands and feet, and a general feeling of malaise. He complained of pain in his neck and continued pressure behind his eyes and has a splitting headache. The pt has seen a neurologist, internal medical doctor and an Ophthamologist. He was dx'd by the Ophthamologist as having post viral encephalitis triggered by the flu vaccination. The pt did state that no spinal tap was performed as of yet. From follow up correspondence received on 12/14/01 additional pt, vaccine, responsible physician, vaccine administrator and laboratory data was provided. From follow up correspondence received on 12/14/01 additional patient, vaccine, responsible physician, vaccine administrator and laboratory data was provided. From follow up correspondence received on 2/11/02 the following information was provided from teh physicians notes dated 1/14/02. The patient returns reporting overall he feels much better. He feels his ptosis is completely resolved. He feels wach eye is moving much better at this time but he questions whether his eyes are crossing inwards more. The patient has previous opthalmic history with regards to his spectacles. When examining his refraction he has a marked optical diffrence between his two eyes with his right eye being much more hyperopic than his left. He is experiencing minimal if any diplopia at this time. The patient is showing a marked improvement in his overall gaze paresis. At present he has relatively full duction in both eyes. His ptosis has also improved. However, he is demonstrating an increase in his objective strabismus angle with partial sensory suppression of his right eye. The fact that this tribasic angle is overall increased at this point is not necessarily concerning. In particular, he had very limited duction in all fields of gaze before which might potentially hide his true angle of strabismus secondary to his relatively late age along with a slightly decreased acuity in his right eye all suggests ahistory of a mild anisometropic amblyopia on the right with partian sensory suppression of that eye chronically. At this time I am very comfortable with his overall progress. From the neurologist office visit notes dated 1/29/02, the opthalmologists feel that his gaze paresis is improving, his ptosis has resolved but he does have an esotropia. On exam, his right eye does tend to go in, he can make it go out by covering his left eye as can be demonstrated with the cover/uncover test. He says he does tend to have some double vision when looking to the right. He does have a history of chronic decreased vision in the right eye but he has no history of double vision in the past and he feels that his right eye did not go in in the past. He is not having any trouble swallowing; he's not having any numbness in his extremities. He is taking TASA and 2 Advil, which the doctor recommended. The etiology of his illness is still not known although some people feel that it is related to his influenza vaccine. There is no good documentation of that nor is there any known incidence of this occurring. Whether this is an early presentation of MS is still uncertain. U 10/26/2001 10/28/2001 2 MRI brain, Orbit cervical spine, Lyme titer, Myasthenia panel - results not provided. PVT UNK Serevent, Flovent Recent viral gastroenteritis Asthma; Previous opthalmic history with regards to his spectacles. He has a marked optical difference between his two eyes with his right eye being more hyperopic than his left. U2001011820 1
0178525 12/04/2001 MD 0.7 0 .4 M 12/03/2001 Then 5.5 month old child who had multiple episodes of eye blinking and eye deviation upward. Tightness of the arms and legs with twitching was also reported by the mother. Entire initial event lasted approximately 2 minutes. Cyanosis was also noted during the event. Diagnosed with new onset seizures. Y Y 4 Y N 08/13/2001 09/15/2001 33 Metabolic studies: pending; MRI: nml; EEG: spike waves in right posterior quadrant but no hypsarrhythmia; SMA6 & CBC: nml PVT PVT NONE NONE 35 week premie, small for gestational age, Pierre-Robin dysmorphic faces 1
0178526 12/04/2001 OH 43.0 43 F 11/25/2001 Pt developed burning down to fingers from site of injection and a large knot at injection site. She developed head shaking, severe joint pain, severe scarring rash, angina, palpitations, gout, arthritis, inability to read and retain information, diminished cognition, and chronic fatigue. There are more adverse events but due to space limitations they are not listed. Y N 05/01/1999 05/01/1999 0 Too numerous to list here. MIL MIL Synthroid and Estratest NONE Hypothyroidism 1
0178527 12/04/2001 CA 1.0 1 .0 M 11/03/2001 Four gran mal seizures, severe rash, fever, diarrhea and breathing difficulty. Diagnosed with autistic behavior. The annual follow up states severe autism, retardation, gastrointestinal disease, seizures, immunoglobulin disorder, mercury poisoning. Y Y 3 Y N 12/02/1998 12/10/1998 8 Hopitalized, EEG, observation PVT PVT PPD Lot 249611 Left arm Otitis Media and sore throat UNK 1
0178528 12/04/2001 AL 12.0 12 F 11/24/2001 Significant reaction to flu shot taken 11/13/2001. Area around injection site had fist sized raised, red, swelling and was extremely hot to the touch, as well as sore, child vomited over 5-6 hours to the point of dehydration, headache and high fever. Y Y 11/13/2001 11/15/2001 2 UNK UNK UNK 1
0178529 12/04/2001 CA 2.0 2 .3 M 11/23/2001 The pt developed severe erythema multiforme, requiring hospitalization, given varicella vaccine, 10/24/01. Pt seen again 11/5/01 with a bacterial upper respiratory and pulmonary infection. Started on Ceclor. On 11/13/01 developed extremely severe erythema multiforme, requiring approximately 5 hospitalization, recovery was complete. Y 5 Y 10/24/2001 11/13/2001 20 NONE PVT PVT NONE NONE 1
0178530 12/04/2001 MI 61.0 61 F 11/21/2001 Onset 11/20/01 7 AM with stomach upset, cramping, chills, diarrhea times 24 degree. U 11/19/2001 11/20/2001 1 PUB UNK Pulmicort, Requip 11/19/01 increased dose Zestoretic, Premarin, Nasacort Environmental allergies, asthma, gall bladder removed. 1
0178531 12/04/2001 MI 65.0 65 M 11/27/2001 Woke up achey all over, arms sore within site of injection. Fever and achey on and off for 2 weeks after, fever up to 100.4 degree. Y U 11/02/2001 11/03/2001 1 PUB OTH 11/23/01 started Biaxin B/O with visit to physician. 1
0178532 12/04/2001 GA 83.0 83 M 11/26/2001 Client received flu vaccine 11/07/2001 approximately 2 days later he noted bruising on the inner aspect of left arm where vaccine given, no redness or swelling noted at injection site, upper arm moist heat to affected area. Y Y 11/07/2001 11/10/2001 3 PUB PVT Tylenol/600mg prn, Tylenol 400 mg TID. NONE Poor circulation extremities. 1
0178533 12/04/2001 CA 13.0 13 F 11/26/2001 Red, raised patch overlying entire left deltoid. Y U 11/23/2001 11/24/2001 1 PVT PVT 1
0178534 12/04/2001 NY 29.0 29 F 11/27/2001 Left upper extremity arm region 1 3/4"x1 1/2" (5cm round) red area, itching. Red rash non raised area Bilateral inner forearm and back of neck. Benadryl taking with relief. 11/27/01 rash faded, red area left upper arm faded. Occasional itching. Still taking Benadryl. Y 11/23/2001 11/24/2001 1 OTH PVT Vancomycin allergy, amoxicillin allergy. 1
0178535 12/04/2001 IN 73.0 73 M 11/26/2001 States rec'd vaccine at 4:15 Thurs.- by 10 PM Thurs. chills causes to bed, sweats (2 blankets and elec on hi) cycled about q8h. Temp ranged from 100-103,5, achey all over. Pink rash on legs, chest, back Fri. AM Took Benadryl and ibuprofen per doctor orders. Felt OK by Sunday. Rash gone by Monday AM. Y Y 11/08/2001 11/08/2001 0 OTH PVT Allergic PCN, Sulfa NONE 1
0178536 12/04/2001 OR 35.0 35 F 10/05/2001 Pt was sent to ER with another employee in private car. Pt check out swollen arm from shoulder to finger tips, right arm. Pt stated that as a child, she had an allergy to mayonnaise, no egg allergy as an adult. Arm began swelling one hour after shot resolved two hours later. Y Y 10/05/2001 10/05/2001 0 PUB PVT Had just recovered from URI with ATB's. Fibromyalgia/chronic back pain 1
0178537 12/04/2001 PA 31.0 31 M 11/28/2001 13:00 nausea and vomiting times 1, 13:55 PM TPR/BP 97.2 Temp 74P 16R, BP 146/88. C/O pain at injection site. Stated in ED had same reaction to Flu vaccine last year ( Denied any past problem with flu vaccine at time of administration). TX: IV NSS and 200 mg Reglan 10 mg IV and Benadryl 25 mg IV. Y Y 11/15/2001 11/15/2001 0 CBC, UA, Chem PVT OTH IV NSS and 2OO mg of Reglan 10 mg IV, Vitamins NONE Diagnosed: Gastroenteritis 2-3 days recovery. 1
0178538 12/04/2001 MA 77.0 77 F 12/03/2001 Nickel size redness to left arm check out itchiness. Denies hardness or pain. Explained need to keep clean, covered and put Bacitracin on. U 11/27/2001 11/29/2001 2 PUB OTH NONE 1
0178539 12/04/2001 SC 41.0 41 F 11/25/2001 Local reaction. Y 10/09/2001 10/10/2001 1 PVT OTH OCP, Claritin D, Chlortrimeton, MVI NONE Healthy except hay fever. 1
0178540 12/04/2001 WV 45.0 45 F 11/28/2001 Lump at injection site "size of small hen egg" appeared next evening. Area pink and warm to touch and tender. Next AM (11/26/01) was still tender and inflamed. Went to Dr. and was given erythromycin. T/D x6 days. 11/29- Per client and area is 1cc swollen and only slightly red in center. No pain with arm movement. Y Y 11/26/2001 11/27/2001 1 OTH PVT Allergy Sulfa and PCN, Toxoplasmosis-eyes; TB converter. WV0113 1
0178541 12/04/2001 UT 17.0 17 M 11/16/2001 Within 12 hours had very high fever. Took Tylenol and it didn't drop temperature. Gave bath and sponge bath to drop temperature. Ears, eyes entire body full red. Then 24 hours later swollen gland and sore throat. Fever dropped but had swollen gland for 2 days. Y 11/02/2001 11/03/2001 1 PUB PVT EES NONE NONE 1
0178542 12/04/2001 FL 38.0 37 F 11/30/2001 Acute muscle atrophy of left arm-base on physical examination. 11/08/2001 11/29/2001 21 CPK done with a result of 70. PUB PVT NONE NONE 1
0178543 12/04/2001 KY 41.0 41 M Received immunization 10 mm at 10:15 AM. Burning at site immediately and arm continued to burn and "achey" after got home, temperature 101.3F. Aching all arm. Low greater fever. Fells like he's been "beat-up." Y 11/26/2001 11/26/2001 0 PUB UNK medication for irritation Bowel Syndrome On medication Cipro for infection in arm. Irritable bowel Syndrome. KY2001090 1
0178544 12/04/2001 CA 80.0 80 M Felt a little dizzy off balance time 3 days, emesis thus Ave without diarrhea or fever. Slight increase in Blood Pressure. No increase confusion, no tinnitus. Y 11/16/2001 11/19/2001 3 NONE PVT UNK NONE Post CVA 1
0178545 12/04/2001 MA 28.0 28 F 11/16/2001 8 hours after IM flu vaccine injected into left deltoid swelling, inflammation, itching, 24-48 "later site measures 30x60, induration. Y 11/14/2001 11/14/2001 0 PVT OTH 1
0178546 12/04/2001 OH 68.0 68 F 11/02/2001 couple of hrs after shot R upper arm became very red, ran fever.(did not take temp); arm swollen. Treated with ice and tylenol. Also had complaint chest pain and sinus problems. Did not seek medical care, came back to clinic 11/2/01,830am. Pt arm (R) red and warm to touch below injection site. Recommended she call primary MD today. Y 10/31/2001 10/31/2001 0 NONE PUB PUB Premarin, vitamins, Lipitor denies illness Denies, had reaction to iodine about 10 yrs ago in test OH0066 1
0178547 12/04/2001 OH 23.0 23 F 11/14/2001 9pm pain at injection site R arm, sore from deltoid to elbow. Redness, swelling shoulder to 3/4 way toward elbow. Hot to touch. Pt is 17 wks pregnant recommended motrin, ice, cold compresses. She will check with OB re: use of motrin. Y 11/13/2001 11/13/2001 0 NONE PUB PUB NONE OH0065 1
0178548 12/04/2001 MA 65.0 65 F 11/13/2001 Three hours after receiving the pneumonia shot in the left deltoid, developed severe painin upper arm to elbow to under arm pit. In 4-5 hours after injection, developed swelling, redness, hotness and "hardness" of upper arm. Also, chills and nausea. Lasted 2 full days then symptoms gradually decreased 3 or 4 days. Y 11/06/2001 11/06/2001 0 NONE PVT PUB Baby ASA, Cardizem, Isordil, Norvac, Visken, Zantac, Premarin, NTG patch NONE Heart disease, allergic to latex, dermatitis, S/P MI, Repair of left rotator cuff AUG 2001. 1
0178549 12/04/2001 TN 55.0 55 F 11/13/2001 Pt states she received flu shot in clinic 11/07/2001. Pt back in clinic 11/08/2001 with aunt so aunt could get flu shot. Pt pointed out site of her flu shot received prior as being "sore". Left arm above elbow red, warm and swollen. Instructed to begin cool compress today, warm tomorrow and Aleve. Y U 11/07/2001 11/07/2001 0 PUB PUB NONE Latex TN01061 1
0178550 12/04/2001 NY 52.0 52 F 11/20/2001 11/19/01 @0930 spoke with pt. C/O hives on both arms and chest area. Not sure if anywhere else don't think so. At injection site LD red, hot, swollen area 8cm around site. C/O itching no SOB, no difficulty breathing. Instructed to call MD or go to ER. Dr office called instructed to take benadryl 50mg po q/4 until itching subsides. On 11/20/01 spoke with pt rash fading, still itches, not as bad, no SOB, states did have hives over entire body. arms, chest, neck, legs and back. Instructed to call 911 or go to ER if any difficulty breathing by MD. Y 11/16/2001 11/19/2001 3 NONE OTH PUB Zoloft 50mg qd, Welbutron bid NONE NONE 1
0178551 12/04/2001 IL 39.0 0 .0 F 11/27/2001 Developed rash on face. U 11/21/2001 11/21/2001 0 OTH PVT NONE NONE 1
0178552 12/04/2001 ND 48.0 48 F 11/20/2001 Local reaction on left arm, occurred approximately 6 hours after administration. Area red, swollen and firm. Also itchy and faded after 2 days of administration. Applied aloe and green tea soothing burn cream one time only. (per pt) Y 11/05/2001 11/05/2001 0 NONE OTH PVT NONE NONE Allergic to gold and metal 1
0178553 12/04/2001 MA 42.0 42 F 11/27/2001 Fever, rash, small bumps reddened and white all over arms, legs, chest, etc. Joint pain (severe), headache, facial, neck swelling, eye swelling and nausea. MD stated "classic" drug or serum sickness/reaction". Symptoms for 2 weeks. Treated with Benadryl and Tylenol. Also worsening in asthma symptoms, increase in asthma meds. MD suspicious of thimersol allergy. No history of egg allergy. Y Y 11/23/2001 11/25/2001 2 NONE PVT OTH Zoloft, Accolate, Flovent, etc NONE Asthma (grade 4), etc fever, oint pain and swellin at injectin site~Hep B (no brand name)~3~32.00~In Patient 1
0178554 12/04/2001 CA 5.0 5 M 11/27/2001 Red, raised patch overlaying entire left deltoid. Y U 11/21/2001 11/22/2001 1 PVT PVT Penicillin 1
0178555 12/04/2001 IN 45.0 45 F 11/27/2001 Hives on legs, some difficulty breathing (is an asthmatic), hoarseness, dizziness, weakness, headaches. Advised to call physician or go to ER if condition worsened. Seen in ER, given Motrin and sent home. Y Y 11/26/2001 11/26/2001 0 PUB PUB NONE Asthma Asthma and arthritis 1
0178556 12/04/2001 MI 7.0 7 M 11/27/2001 more than 30 less than 50 varicella lesions, papules, vesicles and crusted vesicles Y 11/02/2001 11/22/2001 20 PVT OTH NONE Metabolic disorder NOS, microcophage, hearing loss, hypotonia, SOB once. 1
0178557 12/04/2001 OR 63.0 63 F 11/04/2001 The patient broke out in rough purple-like rash approximately 22 hours after the vaccination. The patient had the rash on his arms, chest, back and buttocks. The patient did not have any breathing problems and was afebrile. The patient states she is very uncomfortable due to itching. The patient was treated with Zyrtec, Pforcone and Benadryl. Y Y 11/01/2001 11/02/2001 1 NONE PUB PVT NONE NONE OR200144 1
0178558 12/04/2001 MI 69.0 69 F 11/30/2001 Pt had slight pain and discovered pink rash about 11pm same day (11/26/01) 11/27 pain increased and redness increased 11/28 itching in red area, pain went to middle of forearm. 11/30 pain has dimished 75% itching has subsided but is still pink. U 11/26/2001 11/26/2001 0 PUB PVT NONE NONE 1
0178559 12/04/2001 MA 63.0 63 F 11/28/2001 Rec'd influenza vaccine 11/13/2001 on 1/20/2001 developed progressive generalized muscle pain, night sweats, fatigue lasting until 11/22/01. No other c/o. Reported to BOH 11/27/01. Y 11/13/2001 11/20/2001 7 NONE PUB OTH Atenolol NONE hypertension 1
0178560 12/04/2001 IN 33.0 33 M 11/26/2001 High temp - 103.3F, dizziness, vomiting, weakness, ten hrs of symptoms. Y 11/20/2001 11/20/2001 0 PUB PUB NONE NONE NONE 1
0178561 12/04/2001 NJ 35 F 11/28/2001 Pt c/o headache, vomiting 2 times. Had Flu shot, ate lunch and then vomited about 1/2 hr later, then pt states that she began feeling lightheaded, nauseated, and headaches. Vomited only her lunch. No blood , etc. No other concommittant symptoms noted. No hives, pruritis, shortness of breath, or sensations of throat closing. Pt has a lifelong history of allergies including seasonal, animal, food and other materials. She has an epipen to use prn and takes Claritin for hay fever. Pt noted that she has had the development of a small wheal at her injection sites in the past when she has gotten the vaccine but never had any other concommittant symptoms. No wheal noted today. It should be noted that the pt who has multiple allergies has never manifested a reaction as noted above. She noted that she usually would feel her throat get tight and begin having hives. (which did not occur today). Vital signs remained stable. Treated with Benadryl 50mg/IM followed by oral Benadryl later on in the evening. Symptoms resolved. Pt was discharged in stable condition. Y Y 11/16/2001 11/16/2001 0 OTH PVT NONE Seasonal, food, animal, and other material allergies 1
0178562 12/04/2001 AZ 0.5 0 .5 M 11/28/2001 At 9:30 pt noted to have jerking of both arms, legs, gasping breathing, head rolled back. lasted 10 min per Mom. Y Y 11/27/2001 11/28/2001 1 EEG pending, CBC - all Normal, Metabolic panel - all normal PVT PUB NONE URI NONE 1
0178563 12/04/2001 OR 1.3 1 .4 M 11/01/2001 The mother reports the entire right thigh was hard, hot, very red and swollen. The patient also has some diarrhea. Y 10/29/2001 10/30/2001 1 PUB UNK NONE 1
0178564 12/04/2001 MI 0.3 0 .3 M 11/23/2001 On 11/21/2001 the patient's temperature was 100.3 with erythema and induration at the injection site. On 11/22/2001 the erythema and induration increased to the size of a nickel. On 11/23/2001 the erythema and induration was 2.6cm x 1.5cm. Y Y 11/20/2001 11/21/2001 1 PVT PVT Tylenol NONE 1
0178565 12/04/2001 TN 0.4 0 .4 M 06/20/2001 Post vax, the patient developed a temperature of 104F and was taken to the ER at 11:45 pm after the mother couldn't get his temperature down with medication and sponge baths. The patient was treated with Motrin, his fever broke and he was discharged at 3:00 am. The patient remained alert and active during the time his temperature was elevated. The patient's mother gave him Tylenol without additional problems. Y Y 06/05/2001 06/05/2001 0 PUB PUB TN01057 1
0178566 12/04/2001 TN 14.0 13 F 06/29/2001 Post vax, the patient stated her head feels funny and a little light-headed. The patient was slightly pale and her skin was sweaty. The patient was put on the examining table to lay down with a cool cloth on her head. Y 06/27/2001 06/27/2001 0 PUB PUB NONE NONE NONE TN01058 1
0178567 12/04/2001 MI 55.0 55 F 11/27/2001 On 11/09/2001 the patient noticed 2" red, warm patches on her right arm about 6-8" away from the injection site, on the medial aspect of her arm. The patient denied itchiness, swelling or any symptoms at the injection site. The redness resolved by 11/11/2001. Y 11/07/2001 11/09/2001 2 PUB OTH Arimidex, Tamoxifen, Motrin and Prozac. NONE Allergic to Diloudid, history of breast cancer with bone metastasis and bone marrow transplant. 1
0178568 12/04/2001 GA 43.0 43 F 11/08/2001 Post vax in the left deltoid, the patient complained of her arm being real sore and red and hot. The patient noted white drainage from the left arm. Y Y 10/31/2001 11/01/2001 1 NONE PUB UNK Antibiotic. Injury on 10/30/2001. NONE 1
0178569 12/04/2001 NC 11.0 11 M Approximately 10 minutes after receiving the vaccine, the patient stated that he was feeling hot and short of breath. He then lost consciousness for about 30 seconds. The patient's upper extremities shook during this time. After the patient regained consciousness, he was oriented to person/place only. The patient's vital signs remained stable throughout. Y Y 10/10/2001 10/10/2001 0 EKG = wnl PUB PUB NONE NONE NONE NC01102 1
0178570 12/04/2001 FL 14.0 13 M 11/19/2001 Pt complained of pain and heaviness of right arm since day of vax. The etiology of the arm heaviness was questionable. X-ray of right upper arm ordered with follow-up with neurologist if symptoms did not resolve. Y 08/13/2001 08/13/2001 0 X-ray right upper arm PUB PUB NONE NONE NONE 1
0178571 12/04/2001 TN 18.0 18 F 11/16/2001 Pt developed swelling at injection site, puffiness under eyes and a stuffy nose. Symptoms lasted for 2 hours. Y 11/16/2001 11/16/2001 0 Temp 98.6; BP 120/80; pulse 76 OTH OTH NONE NONE UNK TN01062 1
0178572 12/04/2001 VA 10.0 10 M 11/15/2001 Pt's arm became red, swollen and hot to the touch. Pt noted redness and some swelling on 11/14/01. Pt had no reaction to first hepatitis B injection. School nurse referred pt to private MD for evaluation. Y Y 11/13/2001 11/14/2001 1 PUB PUB NONE NONE NONE VA01036 1
0178573 12/04/2001 NY 0.08 0 .0 F 11/30/2001 Pt was on apnea monitor and had an episode of bradycardia and apnea. Y 10/02/2001 10/02/2001 0 PVT PVT Diflucan, Zantac Thrush GERD 1
0178574 12/04/2001 TN 47.0 47 F 08/15/2001 Pt noted heat and swelling on left arm where injection was given. Pt broke out in a rash on left side of face, chest and back. She took Tylenol and went to bed. The day of report she noted increased swelling and was advised to see private MD. Y 08/13/2001 08/13/2001 0 PUB PVT Connaught PPD, vitamins NONE NONE TN01059 1
0178575 12/04/2001 TN 18.0 18 M 10/30/2001 One day post vax, pt awoke with severe headache and fever. Reporter was unsure of degree of temperature but states it went up and down. Tylenol and Advil were given. Pt referred to clinic. U 10/29/2001 10/30/2001 1 PUB PUB NONE TN01060 1
0178576 12/04/2001 CO 1.08 F 11/27/2001 Pt recvd chicken pox vax at 13 mos of age. She was diagnosed with shingles on 11/19/2001. U 06/27/2000 11/19/2001 510 PUB PUB 1
0178577 12/04/2001 AZ 46.0 46 M 11/21/2001 Pt developed malaise x 3 days. He was more achy at the end of the day. He had red, rash-like papules on upper body and trunk. Y 11/09/2001 11/18/2001 9 NONE PUB PVT 10/26/01 Aventis PPD, C0833AA, left arm, none previously NONE Drug allergy 1
0178578 12/04/2001 NJ 1.3 1 .3 M 11/27/2001 Twelve hour swelling right side of face (right parotid gland) with slight erythema. No fever. No other abnormality. Recovered symptomatically. 11/02/2001 11/26/2001 24 NONE PVT PVT NONE NONE Otitis Media July 2001 1
0178579 12/04/2001 KY 4.0 4 M 11/28/2001 Mother called HD at 3:30 PM reported child was ok, took a nap, woke up at 1:30- 2 AM and she noticed some red spots on face. Later she noticed hyper itching, when she called she said he was broke out from head to toe and complained of having a little belly ache. Says she could not get a hold of doctor and left message. Nurse told mother to give Benadryl according to package directions and q6h and to continue to try and contact doctor. talk to mother next day says she took child to MD by then his rash was gone since he took Benadryl. Also had redness at site of MMR. Mom says after second dose of Benadryl rash was completely gone. MD said if rash went away with Benadryl that it was most likely the vaccine the vaccine. Y Y 11/27/2001 11/27/2001 0 NONE PUB OTH Zyrtec, Nasonex, Singulair, Kyvac for children, And Pulmacort Chronic Asthma Allergies; Reactive Airway Disease; History of febrile seizure was on Tegretal and discontinued on 07/2001 rash~Influenza (Seasonal) (no brand name)~2~4.00~In Patient 1
0178580 12/04/2001 MO 0.2 0 .2 F 11/20/2001 Pt began an uncontrolled, screaming cry 1 hour post vax. This lasted 4.75 hours, from 11:00-15:45. Y Y 11/19/2001 11/19/2001 0 PVT PUB 1
0178581 12/04/2001 NY 0.2 0 .1 F 11/30/2001 About 6 PM on 10/30/2001 pt had an episode of bradycardia. On apnea monitor. Y 10/30/2001 10/30/2001 0 PVT PVT Zantac 0.7ml TID GERD 1
0178582 12/04/2001 PA 4.0 4 M 11/27/2001 Within 5-10 minutes of receiving vax, pt returned to MD's office with hives of face and neck. Pt had no shortness of breath, wheezing or dysphagia. Y Y 11/27/2001 11/27/2001 0 PVT PVT Developmental delay 1
0178583 12/04/2001 TX 1.0 0 1 F 12/03/2001 Pt was presented to the office on 11/29/2001 4 weeks after receiving MMR, with rash for 2 days. Rash was maculopapular, confluent. Fever for 2 days. Y 10/30/2001 11/27/2001 28 PVT PUB NONE NONE Cleft lip/palate 1
0178584 12/04/2001 MA 86 F 11/21/2001 L arm swelling (upper arm) with warmth + diffuse erythema Y Y 11/20/2001 11/20/2001 0 PVT OTH Premarin, ? NONE 1
0178585 12/04/2001 CA 1.6 1 .5 M 11/24/2001 Pt developed a rash x 4 days. Y Y 11/12/2001 PVT OTH 1
0178586 12/04/2001 MI 1.0 1 .2 M 11/19/2001 Pt developed a red swelling and hematoma which lasted 3 weeks. Ice was used to treat. Y 10/30/2001 11/03/2001 4 PVT OTH NONE NONE 1
0178587 12/04/2001 MA 4.0 M 11/24/2001 Pt developed local swelling and itchy left deltoid. U NONE PUB PUB NONE NONE NONE 1
0178588 12/04/2001 OR 79.0 78 M 11/15/2001 Pt developed redness, swelling, heat, stiffness and pain X 5 days in left arm. Y 10/31/2001 11/01/2001 1 PVT OTH NONE 1
0178589 12/04/2001 OR 82.0 82 M 11/15/2001 Pt developed swelling, redness, pain, stiffness and heat at the left deltoid. Y 11/13/2001 11/14/2001 1 PVT OTH Resolving bronchitis Allergy to Biaxin 1
0178590 12/04/2001 FL 1.0 1 .0 M 11/26/2001 Pt developed positive evidence of calcified nodule on left thigh at injection site of DTAP. U 11/12/2001 PVT OTH NONE 1
0178591 12/04/2001 TX 1.5 1 .5 F 11/29/2001 The child had DTAP and IPV vaccine to left thigh. Mother reports the next day that child had reddened spot at injection site and a large nodule with a red spot. This was dx'd as a local reaction to immunizations and is resolving. The pt was treated with Tylenol with codeine syrup 1/4 tsp q 6 hours prn for pain and continue warm compresses. Y Y 11/26/2001 11/27/2001 1 PUB OTH NONE NONE NONE 1
0178592 12/05/2001 MI 99.0 99 M 12/04/2001 High fever 1 AM on 11/23/2001. Taken to hospital. Diagnosis of Urosepsis. Y 11/23/2001 N 11/20/2001 11/23/2001 3 Positive for bacteria in urine, polynephritis, WBC 40,000 +. OTH PVT NONE UNK UNK 1
0178593 12/05/2001 PA 25.0 4 M 03/11/2002 Information has been received from a physician concerning a 25 year old male with no known allergies or psychiatric history and a history of varicella who on 02-NOV-2001, at 11:00 AM, was vaccinated with a dose of MMR (second generation). Concomitant therapy included Recombivax HB. There was no other concomitant medication. It was noted that the pt was seen later that day in the early evening, at 6:00 PM, then disappeared. On 19-NOV-2001 the pt's dead body was recovered in the river. It was reported that it was an assumed suicide. The physician reported that she only saw the client for immunizations. Unspecified medical attention was sought. Additional information has been requested. Follow-up info from the reporter indicated that "in her mind there is no connection between the vaccination and the death." Additional info has been requested. Y 11/19/2001 Y N 11/02/2001 11/19/2001 17 PVT PVT Varicella WAES01112752 1
0178596 12/05/2001 NJ 31.0 F 11/28/2001 Information has been received from a medical assistant and a physician concerning a 31 year old female with no known drug allergies and a recent chicken pox exposure who, on 10/21/00, was vaccinated with varicella virus vaccine live. There was no concomitant medication. It was noted that the pt was vaccinated because she had been exposed to chicken pox. A urine pregnancy test was obtained before vaccination which was negative and her last menstrual period was 10/4/00. On 11/7/00, a serum pregnancy test was done and showed positive results. It was noted that there was no report of rash at this time. Follow-up information from the medical assistant, indicated that the pt had a spontaneous abortion early in her pregnancy. U 10/21/2000 Serum beta-human 11/7/00 (+); Urine beta-human 10/20/00 (-) OTH OTH UNK Varicella exposure WAES00110752 1
0178597 12/05/2001 7.0 M 11/30/2001 The child received his first injection of Havrix on 22-AUG-2000. In December 2000, approximately four months post immunization, the child reportedly began to experience seizures. He was seen by a physician and treated with unspecified medication. The child received his second injection of Havrix in April 2001. As of 26-NOV-2001, the child's mother reported that he was receiving an unspecified medication, which was controlling the seizures. Seizures are considered GSK medically serious. Y N 08/22/2000 12/01/2000 101 OTH OTH 20010283681 1
0178598 12/05/2001 MI 37.0 33 M 09/20/2002 The pt reported that he received his first SC injection of Engerix-B on 05-APR-1997 and immediately experienced a "really bad" headache. Treatment and outcome of the headache were not specified. The pt reported that he received his second SC injection of Engerix-B on 17-MAY-1997. Approximately one month after receiving the second injection, in June 1997, he reportedly began to experience weakness, loss of memory, shortness of breath and confusion. He made "several trips to his doctor's office for tests". The pt reported that diagnoses of "drug-induced lupus" and an autoimmune "blood disorder" (NOS) were made. Treatment of these events was not specified. He reported that in June 2001, he experienced a "small" stroke and was hospitalized for two days. The pt reported that "the doctor thinks there may be some genetic sensitivity to the vaccine", since his mother experienced autoimmune disorders following the receipt of a different brand of hepatitis B vaccine. As of 27-NOV-2001, the "drug-induced lupus" and autoimmune "blood disorder" were ongoing. the outcome of the stroke was not specified. Information was received from the vaccinees' current primary physicians on 9/9/02. The physician stated that he first saw the vaccinee on 3/8/01. At that time, he reported "fainting spells/dizziness" and "blurred vision/double vision". He reported that he hit his head on concrete at 2 years of age. At 4 years of age, he began having migraine headaches, which continued until age 16. At age 16, a diagnosis of temproal lobe epilepsy was reportedly made. The vaccinee stated that in 2000, "the question of epilepsy arose again". The vaccinee was taking Valium for "stress" at the time of the initial evaluation. The physician's assessment was "anxiety disorder per history." He prescribed Effexor. On 4/9/01, the vaccinee reported that Effexor made him dizzy; Effexor therapy was discontinued. The vaccinee returned to his primary physician on 6/8/01. He reported that he began "having visual changes" in approximately 1999. "Had EEG, which was normal and then one year ago had questions of seizures and was seein in ER for a visual loss, which lasted half hour and was assoicated with headache. Was diagnosed with ocular migraine and the episodes occurred once or twice a month." The vaccinee reported that he experienced visual change, headache, loss of feeling in the left hand, anxiety, "respiratory distress", and left-sided facial weakness on 5/30/01. He was evaluated in the emergency room. CT "was found to be normal". The vaccinee reported that while on a trip on 6/6/01, he expereinced visual changes, headache, confusion, inability to read, and was flaccid. He was evaluated in the emergency room. all symptoms resolved within one hour. The "working" diagnosis was reportedly hemiplegic migraine, and a physician prescribed Depakote. The vacccinee's primary physician referred him to a local neurologist. The vaccinee was evaluated byt he neurologist on 6/15/01. at that time, the vaccinee reported that he had begun having headaches in 1998, and for the past year they had been occurring once or twice per week. The headaches were sometimes preceded by kaleidoscopic colors and visual loss, described as "seeing only parts of objects." He reported that he was unable to tolerate fluorescent lights. The vaccinee reported that he had been given a diagnosis of ocular migraine. The vaccinee described the episode during his trip as occuring on 6/7/01 and as "another episode of visual disturbance when he saw kaleidoscope colors. He closed his eyes and went to sleep and half an hour later whe woke up feeling confused. He noticed that he could not feel his left upper extremity. Subsequently, he had a feeling of generalized weakness and numbness....He couldn't recall the name of his wife an was unable to read signs. He was also noted to be hyperventilating. He was admitted overnight. Reportedly he had neurologic evaluation was noted to have cognitive impairment. Gradually these symptoms resolved. He was told the he was a hemiplegic migraine." The vaccinee also reported loss of fluency of pseech, word finding difficulty, mood swings, loss of balance, stumbling, and easy loss of temper since 6/7/01. The neurologist's impression was "migraine complicated by transient ischemic episodes including an episode of confusion. he has noted improvement in his headache since he was started on Depakote. The last few episodes may have been related to excessive use of caffeine, stress, and irregular sleep habits. Currently there are no focal or lateralizing neurologic deficits noted. MRI studies, including MR angiogram, cannot be obtained as he has a history of back surgery with placemtn of metallic plates." The neurologist recommended continui9ng Depakote therapy and prescribed aspirin 325mg daily. On 7/25/01, the vaccinee returned to his primary physician, after taking Depakote for approximately six weeks. He reported myalgias and arthralgias. He stated that laboratory anaysis performed by his neurologist revealed "elevated ANA (antinuclear antibody) titers and decreasing platelet counts." Please see laboratory data section. The primary physician wrote, "concern is that these may be medication induced." The primary physician discussed this with the vaccinee's neurologist, who referred the vaccinee to a rheumatologist. Depakote therapy was discontinued on an unspecified date, and Depakote was added to the list of allergies in the vaccinee's medical records. The vaccinee was evaluated by the rheumatologist on 7/31/01. The vaccinee reported "some sun sensitivity" at that time. The rheumatologist noted. "He has possibly had thrombocytopenia in the past but his last platelet count in June was normal." The vaccinee "has intermittent arthralgias/myalgias with some activity. His most significant complaints of late have been his knees, bilateral heels and occasionally the left elbow." He reported a 20-pound weight gain over the previous six weeksn and "intermittent difficulty with hearing loss". No abnormalities were noted on physical examination. The rheumatologist's impression were "1. Positive ANA, no physical evidence of collagen vascular disease. 2. Maybe associated antiphospholipid syndrome. 3. History of migraines and associated seizures." The rheumatologist referred the vaccine to a hematologist, to evalute the possibility of antiphospholipid syndrome. On 8/15/01, the neurologist recommened that the vaccinee use continuous positive airway pressure (CPAP) for the treatment of obstructive sleep apnea. The vaccinee could not tolerate this, so bilevel positive airway pressure (BPAP) was recommended. The vaccinee was subsequently evaluated by a hematologist. Date of first evaluation was not provided. The vaccinee returned to the neurologist on 12/14/01. The physician wrote, "reportedly his mother had developed drug induced lupus following a hepatitis b vaccination. When he learned about this from her, it occurred to him that he had also received a hepatitis b vaccination about three years agao. He wonders if he has developed drug induced lups from this vaccination." The neurologist's impressions were "1. MIgrainses and migraine related phenomena including episodes of confusion. He had a previous normal awake and sleep EEG. 2. Obstructive sleep apnea syndrome. #. Antiphoapholipid antibody syndrome." The neurologist noted that the aspirin dosage had been decreased to 81mg daily, and he recommended continuation of that. The vaccinee returned to the neurologist on 4/18/02. The neurologist wrote that the vaccinee was not able to tolerate bilevel positive airway pressure for the treatment of obstructive sleep apnea. "He is aware of the significance of his sleep apena syndrome and its impact on his migraines and other symptoms which have been fetl to represent transient ? attacks or migraine related phenomena. He is aware that sleep apena syndrome is a risk factor for stroke. He is currently on Aspirin 81mg p.o. qd. Plavix was being considered for his antiphospholipid antibody syndromre, however, he has been concerned about the side effect of thrombotic thrombocytopenic purpura that has been reported with the use of Plavix, hence he has opted to stay with Aspirin". The neurologist impressions were 1. Migraine and migraine related phenomena vs. transient ischemic attacks. 2. Obstructive sleep apnea syndrome. 3. Antiphospholipid antibody syndrome." The most recent information, received on 9/9/02, indicated that migraines, possible transient ischemic attacks and anitphospholipid syndrome persisted as of 4/18/02. "Drug induced lups" is considered medially serious. Additional info was received on 7/15/03, indicated that the drug-induced lupus and lupus anticoagulant persisted as of 7/15/03. Information received on 9/9/02 indicated that migraines, possible transient ischemic attacks, and antiphospholipid syndrome persisted asa of 4/18/02. "Drug-induced lupus" is considered medically serious (OMIC). Y Y 1 U 05/17/1997 06/06/2001 1481 PVT OTH Diazepam, Venlafaxine hydorchloride Allergic reaction to codeine, anger, anxiety disorder, atypical bipolar depression, back surgery, chickenpox, chronic back pain, chronic cough, degeneration of lumbar, GERD, head injury, hernia, hostility, measles, migraine, mumps, obstructive sleep apnea, sinus problems, temporal lobe epilepsy, ulcerative colitis; Medical history, concurrent conditions and medications were not specified. Family history was significant for rheumatoid arthritis and "other autoimmune diseases" in the pt's mother. the rheumatoid arthritis and "other autoimmune diseases" reportedly occurred after the mother had received two injections of Recombivax-HB which were administered on the same date as the pt's injections of Engerix-B. 20010284721 1
0178601 12/05/2001 TX 5.0 5 M 11/28/2001 A 5 year old male was vaccinated on27-AUG-2001 at 9:20 AM with MMR (second generation) SC in the LA. Concomitant vaccinations that same day and time included the first dose of Varivax SC in the LA, the seventh dose of Tripedia IM in the LA and the sixth dose of IPV SC in the LA. There was no illness at the time of vaccination. On 27-AUG-2001 at 10:15 AM the pt's mother called the physician's office and informed them that the pt experienced difficulty breathing, a red "slap like" rash all over with extreme itching. The mother was instructed to go to the doctor or ER. The pt's mother called later in the afternoon to report an ER visit. the pt received prednisone, Prelone times 3 days and Benadryl. It was unknown if the pt recovered. This was originally reported by a nurse. Upon internal review, the pt's difficulty breathing was determined to be an other important medical event. Additional information has been requested. Y U 08/27/2001 08/27/2001 0 PUB OTH UNK WAES01112405 1
0178603 12/05/2001 SC 1.0 1 .1 M 06/03/2002 Information has been received from a consumer concerning her approx, 12 month old son who on 7/21/99 was vaccinated with 1 dose of MMRII. For 3 months, post vax, the mother thought that something was wrong with her son. She reported that she thought he had developed autism. About 3 months after that, in approx. 1/00, the pt was vaccinated with a dose of Hib conjugate vaccine and a dose of diphtheria toxoid/pertussis vaccine/tetanus. Then, 6 months after that, in approx. 7/00, the pt was vaccinated with a dose of varicella virus vaccine live. Within 12 hours, post vax, the pt was very lethargic and would not move for the next 2 days, his ears were bright red and he had a fever. It was noted that the pt never had a fever until the varicella virus vaccine live and the mother thought something was wrong. It was also reported by the mother, that for some time she did not think her son had autism. The pt sought unspecified medical attention. Follow-up information was received on 11/28/01, from a physician who noted that the patient's mother had an uncomplicated pregnancy and delivery. The patient had no significant past medical history and no allergies (previously reported aas having milk intolerance). The patient's mother reported to the physician that the child was "well" up until the MMR vacine. It was reported that "After the MMR, the mother noticed the child stopped talking, and had behavioral changes. In the charrt that was transferred to this physician, another physician, who gave the patient the vaccine, had documented that the child was walking at 9 months, was imitiating ana had a vocabulary of 1-3 meaningful words. This reporting physician noted that he had first seen the patient in June 2000 adn he had already had the diagnosis of Autism. The physician could not report when the diagnosis was made. On this visit, the physician noted that the child had behavioral problems, speech and comprehension deficits. The patient was referred to a speech and language therapist adn a neurologist. It was noted that these visits did not take place until April 2001. On February 14, 2001, the physician saw the patient adn he also received teh first does of varicella virus vaccine. The physician reported that he did not know that the child had developed a fever, lethary, bright red ears and a lack of movement for 3 days. He reported that the mother of the patient did not call the office to report this event nor did the patient come into the office for a visit. The patient was not seen again in the office until June 2001. The physician noted that the mother of the child was convinced that her child's Autism was associated with the MMR vaccination. The physician reported that the child was showing some improvement and that he was beign treated with alternative therapies of diet and vitamins, and it seemd to be working "it is making him better". The physician noted that the patient was three years old now, and he was getting better at "toliet training" also. Follow-up information from a physician noted that the patient was first seen at this office at 12 months of age and the last office visit was at 17 months of age. The physicain noted that there were no significant illnesses or concerns. The patient transferred to another physician who was not known to this office. Upon internal review, the pt's autism was considered to be an "Other Important Medical Event". (OMIC) Follow up info has beenreceived stating that this case was in litigation. The pt had received a total of fifteen doses/injections that contained toxic mercury and were administered by his pediatrician during hte time from between his birth and the age of two. Before completing the schedule of thimerosal injections, the pt had been developing normally and demonstrated social, language, cognitive, behavioral and physical skills appropriate for his age. It was reported that in additiona to "disintegrtive," 'regressive," "late onset," "degenerative" autism, the pt displayed symptoms of neurological damage consistent with mercury poisoning, including losing his language skills, engaging in repetitive and stereotypical behaviors, suffering from diminished cognitive ability and becoming socially withdrawn. The pt is presently receiivng medical treatment for the damage he sustained by mercury poisoning. Upon internal review, the pt's autism, neurological damage and mercury poisoning were considered to be other important medical events (OMIC). No further info is available. Y N 07/21/1999 07/21/1999 0 PVT OTH Vitamins and minerals Milk intolerance WAES01112210 1
0178608 12/05/2001 NJ 1.25 1 .3 M 11/29/2001 Information has been rec'd regarding a case in litigation which concerns an approximately 5 yr old male pt who on 7/25/96 was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation). It was reported that less than a year form the date of 11/01/01 the pt was first diagnosed and discovered to have mercury poisoning and related severe mental and physical injuries. Upon internal review, mercury poisoning, severe mental and physical injuries were determined to be other medical events. No further information is available. Y U 07/25/1996 OTH OTH UNK UNK WAES01112468 1
0178609 12/05/2001 WV 5.0 4 M 11/20/2001 Excessive thirst within 24 hours. Frequent urination, sunken eyes, fruity breath. Injections Wednesday. ER on Sunday. Diagnosed with new onset diabetes. per 1 year follow: Pt ahs not recovered. Pt has Type 1 Diabetes now. These symptoms developed within 24 hours of vaccination. There should be warning on public information that this could happen to children where diabetes runs in the family. Y Y Y 5 Y N 05/09/2001 05/09/2001 0 02/20/2001 sugar level normal. On 5/13/01 sugar 740. PUB OTH Very healthy child NONE 1
0178610 12/05/2001 CA 0.55 0 .6 M 12/02/2001 Almost 7 month old, previously healthy male with 2 minute episode of altered level of consciousness in which eyes were rolled back and trunk was flexed. Infant staring straight ahead and not responsive. No tonic donic movements. Admitted to hospital 12/02/2001 for work up of new onset seizures. Pt not febrile. Positive 11 year old brother with history of febrile seizures. Hospitalized. Y Y 1 Y 11/30/2001 12/02/2001 2 CT Heart-wnl; Chem 7-wnl; urine tox screen-neg; CBC16.5; urinalysis-SG 1013, pH 5 etw neg. PUB PUB PPV Lederle Lot 480-896 IM right thigh 2 previous doses. Fluoride PO. NONE 1
0178611 12/05/2001 CT 56.0 53 M 10/29/2001 Joint pain, continuos and throughout the body. No treatment has been effective. Per 1 year follow up: Pt did not recover. No change in symptoms. Y Y N 05/01/1999 05/01/1999 0 Lyme disease 3 times HLA-DR4-positive PVT PVT NONE Penicillin and migraine headaches 1
0178612 12/05/2001 WA 1.56 1 .6 M 11/27/2001 Seen 11/18/01 with progressive lower extremity weakness. By 11/30/01 could not move lower extremities: had loss of reflexes. Sent to ED where diagnostic work up began. Diagnosis of Guillain-Barre Syndrome ultimately made. Per 1 year follow up: Pt recovered. Done well with therapy time. Y 4 U 11/06/2001 11/16/2001 10 Normal head CT scan CSF increased protein, 2 WBC /mm3 PVT PUB autoimmune pancytopenia, chronic atelectasis, cirrhosis RML pneumonia, hepatosplenomegaly, hepatitis , autoimmune pancytopenia 1
0178613 12/05/2001 MO 62.0 62 M 11/26/2001 Hives within 5 minutes after flu injection, tachycardia and became short of breath and thought he was going to pass out. Sent to ER and was hospitalized for atrial fibrillation. Y Y 4 Y 11/16/2001 11/16/2001 0 Penicillin, sulfa and corn based substance PVT PVT Synthroid 125 mg and Centrum Silver OTC. Abnormal ECG Hypothyroidism; hypertension; hyperlipidemia; drug depend (alcohol abuse) 1
0178614 12/05/2001 MI 1.25 1 .4 M 11/29/2001 Pt right leg swelled up to knee to hip and became hard and red. Pt was admitted to hospital for concern of cellulitis. Y 1 Y 11/20/2001 11/22/2001 2 PVT PVT NONE redbess, swelling at site~Pneumo (Prevnar)~2~0.00~In Patient 1
0178615 12/05/2001 OK 44.0 43 M 11/29/2001 Anthrax vaccine developed cramps and joint pains. Joints hurt from time to time, comes and goes to include hip, knees, and elbows. Y 05/29/2001 06/05/2001 7 NONE MIL MIL Nicoderm, Aspirin ` Hypoglycemia until age 7, and tobacco use 1
0178616 12/05/2001 MD 50.0 47 M 11/23/2001 Approx. 1 month after the 3rd shot, he experienced numbness in his calves. The numbness is accompanied by tingling and occurs with prolonged sitting and driving. The numbness and tingling extends distally to the toes but does not radiate above the knee. The symptoms are relieved with movement for a few minutes. These symptoms persist today. During this time his lab work showed a CBC with a slightly low HCT, but normal indices. No anemia studies were performed and he was not put on iron replacement therapy. He also had increased pain in his left knee. He was evaluated locally and told his symptoms were the result of normal wear and tear. He states that the joint pain is manageable but annoying. He currently takes Glucosamine Chondroitin once a day, which he states helps his joint pain but does not fully resolve it. In 8/01, he began experiencing left-sided abdominal pain and an increased number of loose stools. He attributes these symptoms to starting after swallowing contrast for a radiologic study on 7/30/01. These symptoms have persisted and increased in severity. Currently he is experiencing constant left-sided abdominal pain as well as loose stools following every meal. He tried over the counter remedies, such as Imodium, with only minimal and temporary relief. He also tried over the counter fiber tablets, which he states made the pain worse. He has noticed some weight loss during this time. In 9/01, he began experiencing increased episodes of dizziness and light-headedness. He denies any ringing in his ears. This dizziness has impacted his balance; however, he has not had any episodes of falling. He has not experienced headache with the episodes of dizziness. At this time he has not yet been evaluated for the dizziness. He was referred to oncology for evaluation. It was determined he did not have cancer; however, the oncology service will continue to monitor him for any changes. He has vertigo without tinnitus. N 02/08/1999 03/08/1999 28 7/23/01 CBC (HCT 41.9); 7/3/01-CBC (HCT 39.1); HGB-13.2; CXR-lung nodules; CT of chest-lung nodules and too numerous to count hypo-dense lesions in the spleen. MIL MIL Multi-vitamin; Glucosamine Chondroitin NONE Removal of fatty tumors; tonsillectomy as a child; exposure to smoke, during 9/11/01 terrorist attack at the Pentagon 1
0178617 12/05/2001 NJ 23.0 23 F 11/03/2001 The pt's right upper arm was red, itchy and warm to touch, immediately after flu injection, 9" X 13". Temperature was 98.8F. Y 11/03/2001 11/03/2001 0 MIL MIL Orthocycline; birth control NONE NONE 1
0178618 12/05/2001 WY 40.0 40 F 12/03/2001 Pt developed a gross generalized pruritic rash, myalgia, headaches, dizziness and fatigue. All symptoms improved with exception of the rash. Treatments: Symptomatic treatment with Benadryl, Tylenol, several types of ointments/creams, oral steroids and antihistamines. Y N 11/14/2001 11/15/2001 1 NONE PVT OTH NONE NONE Allergy to Penicillin and latex 1
0178619 12/05/2001 GA 54.0 54 F 11/08/2001 Pt states she developed redness and swelling at the site of the pneumococcal vaccine, 24 hours, post vax. She was seen at Urgent Care 72 hours, post vax, and treated with steroids and antibiotics. She states that her husband, who received the vaccine on 11/2/01, had a similar reaction and was treated for the same. Y Y 10/31/2001 11/01/2001 1 PUB PUB NONE 1
0178620 12/05/2001 GA 56.0 56 M 11/08/2001 Wife presented to HD stating she saw physician for redness, swelling at pneumococcal vaccine. States husband had same reaction. States husband was treated with steroids and antibiotics just as she was. Y Y 11/04/2001 11/05/2001 1 PUB PUB UNK UNK NKDA 1
0178621 12/05/2001 MN 31.0 31 F 12/03/2001 Severe headache lasting over 24 hours. Very large hard bump on arm from shot. Y 11/29/2001 11/29/2001 0 PVT OTH Birth control and Demulen NONE NONE 1
0178622 12/05/2001 VA 25.0 25 F 11/29/2001 Injection site red, a little swollen and warm (very) to touch, itchy. Taking Benadryl and ibuprofen. Y 11/26/2001 11/27/2001 1 OTH PVT 1
0178623 12/05/2001 AK 48.0 48 F 11/27/2001 Flu shot, pt noted area of redness over major portion of upper arm including injection site. Described as "flat pink, non-tender but itchy", warm. Cleared up by 1 week later. On 11/22/2001 pt diagnosed with flu and noticed that red spot on arm had returned, then disappeared. Y Y 10/25/2001 10/26/2001 1 PUB PUB NONE NONE AK200171 1
0178624 12/05/2001 NJ 60.0 60 F 11/29/2001 11:50 Am vaccine given, stated that at 12:30 PM eyes itchy, 2:15 PM presented with face swollen and itchy. No acute distress. Pt's physician uncooperative. given 0.2 epi per MD at 2:30 PM and at 2:40 better and at 4 PM much better. Fine the next day. Y 11/01/2001 11/01/2001 0 UNK PVT Diagnosed with multiple allergies 1
0178625 12/05/2001 WY 40.0 40 F 11/30/2001 Severe headache, neck ache, rash upper arms and legs, fever, body aches, erythema at injection site. Starting to recover 11/30 after Benadryl and Vicodin. Y Y 11/26/2001 11/27/2001 1 PUB PVT Esterase, Synthroid and Fosamax 1
0178626 12/05/2001 CT 41.0 41 F 11/29/2001 The patient reported progressive numbness from the fingertips on her left hand, to the fingertips on her right hand, to the toes on both feet. The patient experienced a feeling of heaviness in both forearms. These symptoms began 15 minutes after the injection. U 11/19/2001 11/19/2001 0 NONE PUB PVT NONE NONE NONE 1
0178627 12/05/2001 WI 53.0 53 F 11/15/2001 11/13/2001 in the PM, the patient had discomfort in her right arm and hand and felt numb by midnight. The patient awakened in extreme pain and called her MD. The pain is constant down the patient's right arm and she is unable to bend her elbow. The patient was treated with Vicodin and an anti-inflammatory. The patient has pain in the right axillary region, near the anterior scapula. Y Y 11/13/2001 11/13/2001 0 PUB PVT Paxil, Arthro-7, Calcium, Vitamin E, Multivitamin and alfalfa. Fibromyalgia. 1
0178628 12/05/2001 KS 66.0 66 M 11/20/2001 The patient developed hives on both arms and behind his knees and near the joints. The patient's lip was swollen in the A.M., but the shot may not be related. Y 11/19/2001 11/20/2001 1 UNK UNK NONE Allergic to mold and pollen. 1
0178629 12/05/2001 MI 32.0 32 F 11/28/2001 11/22/2001 post vax, the patient developed fiery erythema, hot to touch, palpable hardness and extreme pruritus of the lateral aspect of the upper arm from the acromiun process to the elbow. On 11/23/2001 the patient experienced body wide pruritus with diffuse, reddened blotchy areas body wide. The patient self-medicated with oral Benadryl. On 11/28/2001 the injection site had a 6cm area of diffuse redness. The patient complained of mild to moderate pain at the injection site. The other symptoms were resolved. Y 11/21/2001 11/22/2001 1 OTH PVT NONE NONE NONE 1
0178630 12/05/2001 NH 79.0 79 F 11/29/2001 The patient experienced tremors and chills approximately 4 hours after the vaccination. These symptoms lasted 4 hours. The patient experienced lethargy the following day. Y 11/21/2001 11/21/2001 0 PVT PVT Prinivil, coumadin, thyroid, and Atrovent NS. Hypothyroidism, fibromyalgia, arthritis and hyperlipidemia. 1
0178631 12/05/2001 MI F 11/28/2001 The patient developed hives/rash over her entire body. This began approximately 1 hour following the injection. The patient was treated with Medrol dose pack, oral Benadryl and Benadryl cream. Y Y 11/26/2001 11/26/2001 0 NONE PUB PUB NONE NONE NONE 1
0178632 12/05/2001 IL 34.0 34 F 11/27/2001 The patient stated she developed a rash which spread over her entire body in one weeks time. This started 24 hours after the vaccine was given. Y Y 11/12/2001 11/13/2001 1 OTH PVT NONE NONE 1
0178633 12/05/2001 NH 25.0 25 F 11/28/2001 The patient was seen for swelling and redness at the injection site 24 hours after the injection. The area of redness was 5cm in diameter. The patient's temperature was 99.6F. The patient was treated with Tylenol and ice. Y 11/26/2001 11/27/2001 1 NONE PVT PVT NONE Allergic to Keflex and Bactrim. 1
0178634 12/05/2001 NM 43.0 43 M 11/29/2001 The patient developed swelling, fluid build-up and soreness under his left arm. The soreness went away after 48 hours. The swelling lasted for approximately 5 days. The patient took Advil for the first 48 hours. Y 11/14/2001 11/15/2001 1 NONE MIL MIL NONE NONE NONE 1
0178635 12/05/2001 TX 25.0 25 F 11/30/2001 Three days post vax, the patient developed left arm and shoulder pain that occasionally radiates to the left hand. The patient was seen on 11/23/2001 by the physician for these symptoms. Y Y 11/13/2001 11/16/2001 3 PVT PVT NONE Allergic to amoxicillin. 1
0178636 12/05/2001 FL 0.3 0 .3 M 12/26/2001 The night after the vaccination the patient had swelling and redness in the left thigh and a temperature of 106F which subsequently resolved with ibuprofen. No other serious problems occurred. Y 11/15/2001 11/15/2001 0 PVT PUB NONE NONE NONE 1
0178637 12/05/2001 NY 1.25 1 .2 M 11/29/2001 The patient's left arm was red and swollen. The Dr advised warm soaks. On 11/29/2001 the patient's mother states the patient's arm is improved. Y Y 11/26/2001 11/27/2001 1 NONE PUB OTH NONE Very sensitive skin; rash after beard or lipstick contact. 1
0178639 12/05/2001 UT 1.25 1 .3 F 11/30/2001 Information has been received from a HCP concerning 1 15 month old white "well" female who on 23-AUG-2001 was vaccinated with the third dose of Comvax administered IM in the left leg. Concomitant therapy included Prevnar administered in the right leg, DTP administere in the left leg and IPV administered in the right leg. the following morning, on 24-AUG-2001, the pt woke up with hives from head to toe on the left side of her body. The pt's mother called the Pediatrician's office and reported starting Benadryl. Subsequently, the pt recovered. It was noted that the pt received the three doses of Comvax at 2 months, 4 months and 12 months of age. No further information is available. Y 08/23/2001 08/24/2001 1 UNK PVT PVT Antibiotic allergy WAES01092103 1
0178643 12/05/2001 NY 0.4 0 .4 F 11/30/2001 Information has been received from the pt's mother concerning her 20 week old white daughter who on 06-SEP-2000 at 1:20 PM was vaccinated in the left arm with a second dose of Comvax. Concomitant therapy included a second dose in the left arm of DTP, a first dose in the left arm of Prevnar and a second dose in the left arm of IPOL. The pt's other reported that she then developed hives and difficulty breathing. She was given Benadryl for the hives and the symptoms went away. Follow up information has been received from a physician who reported that on 06-SEP-2000, the pt experienced a mild local reaction with a spreading red macular rash around the Comvax injection site. The rash spread from the face the the abdomen. It was noted that the pt had no distress and no respiratory difficulties. It was also noted that the pt was treated with 1/4 teaspoonful of Benadryl and the rash decreased significantly in ten minutes. No lab tests were done and the pt recovered. no further information is available. Y Y 09/06/2000 09/06/2000 0 NONE OTH OTH NONE WAES01032655 1
0178644 12/05/2001 NJ 0.08 0 .1 F 11/30/2001 Information has been received from a LPN concerning a 28 day old female who on 09-MAR-2001 at 10:45 AM, the pt received a first dose in the right thigh of Comvax. Concomitant vaccine therapy that day included a first dose in the right thigh of Prevnar and a first dose in the left thigh of ACEL-IMMUNE. At the time of this report, the pt had no adverse symptoms. Unspecified medical attention was sought. Follow up information received from the physician's office indicated that the pt's mother reported the pt ran a temperature and had local reactions (swelling, limp) following the vaccinations. No further details provided. Additional information has been requested. Y U 03/09/2001 03/09/2001 0 Body temp PVT OTH NONE WAES01031034 1
0178645 12/05/2001 PA 0.5 F 11/30/2001 Information has been received from a RN concerning a 6 month old female who was vaccinated with Comvax. The pt was also vaccinated with the second dose of Prevnar and ACEL-IMUNE on the same day. Four days post immunization, the pt developed a fever greater than 102.2 F and rash. No further details were provided. Additional information has been requested. U PVT OTH UNK WAES00122047 1
0178646 12/05/2001 IN 32.0 32 M 11/22/2001 After receiving 3rd dose of Lymerix, developed nausea, vomiting and anxiety. Went to ED, was given IV Benadryl. returned to feeling normal over next hour. Was released to go home. Y Y 05/14/2001 05/14/2001 0 Blood sugar and ECG-wnl OTH PUB 1
0178647 12/05/2001 MI 5.0 5 F 11/27/2001 08/21/2001 MMR vaccine. Day 8 arthralgia, skin itching, knees, fist, hands intermittently. Swelling in arm, basically afebrile. Faint rash. Questionable spots. N 08/21/2001 08/29/2001 8 PVT PVT NONE 1
0178648 12/05/2001 AR 4.0 4 M 11/08/2001 Pt arm red and swollen 3" by 6". Mother noticed at 1600 11/07/2001. Child playing as usual without complaint. Y 11/06/2001 11/07/2001 1 PUB OTH NONE NONE 1
0178649 12/05/2001 PA 11.0 11 M 11/19/2001 Approx 1 inch in diameter pink raised area noted back of right upper arm where student states chicken pox vaccine was injected. both student and mom state noticed last night, deny other problems. Student states it itches now that he noticed it. 11/08/2001 11/18/2001 10 OTH PUB Allegra daily and Maxair Autohaler PM NONE Asthma; environmental allergies 1
0178650 12/05/2001 2.0 U 11/30/2001 Information has been received from a LPN concerning seven pts who were vaccinated with Comvax. The reporter noted that seven out of ten infants had experienced a reaction at the injection site described as hard, size of golf ball, tender to touch and slightly red. The experiences last 6-8 weeks. The pts were "mostly two months and a couple were four months old". The pts sought unspecified medical attention. No further details were provided. Additional information has been requested. Y Y UNK UNK UNK UNK WAES00101331 1
0178651 12/05/2001 UT 0.25 0 .3 F 11/30/2001 Information has been received from a LPN concerning a 15 week old Caucasian female who on 14-JUL-2000 was vaccinated wih the first dose of Comvax. Concomitant vaccinations that same day included the first dose of Tripedia and the first dose of IPOL. Following vaccination the child cried for four hours. In follow up it was reported that the continuous crying lasted for 3 hours. On 05-DEC-2000 at 3:30 PM, the child was vaccinated with the second dose of Comvax in the left leg. Concomitant vaccination that same day included the second dose of Tripedia and IPOL in the left leg. On 05-DEC-2000 the child developed a rash that resolved in 20-30 minutes. Later the same evening, the facial rash returned and was also seen on the child's arms and legs. The pt's rash resolved within 30 minutes. In follow up, the LPN reported that 15 minutes after vaccination the pt developed hives on her face that disappeared after 20 minutes and later that night the pt developed hives allover her body (previously reported as a rash). It was noted that the pt had hives 3 times. in follow up, the nurse reported that the pt's mother was instructed to give Benadryl. Twenty minutes later, the pt's hives disappeared. There were no other problems. No other information is available. Y Y 07/14/2000 07/14/2000 0 PUB OTH NONE WAES00120489 1
0178652 12/05/2001 NJ 1.0 1 .0 M 11/30/2001 On 15-DEC-2000, (at approximately 2 PM), the pt was vaccinated with the third dose of Comvax IM in the thigh. On the morning of 16-DEC-2000 at approximately 10 AM the pt developed a fever that was noted to be a very toxic febrile reaction. In the evening of 16-DEC-2000, the pt's fever went to 103 to 104 degrees and he was treated with Tylenol liquid. The pt was actually ill with fever, irritability and a decreased appetite. the pt also had erythema at the thigh injection site (dime-size) which subsided over 72 hours. On 17-DEC-2000 the pt was seen by his pediatrician. At this time the pt has a fever of 101 degrees and the child had a bump on his outer thigh at the injection site. A blood count was normal. The pediatrician felt the pt's experience was viral and not related to Comvax. It was reported that the pt recovered on 17-DEC-2000 PM. Follow up information received from the physician indicated that no further adverse sequelae were noted since the third Comvax vaccination. At the time of this report on 29-JAN-2001 the pt had not received any additional vaccines. No further information is available. Y Y 12/15/2000 12/16/2000 1 CBC-wnl and temperature measurement PVT PVT UNK Slight febrile reaction (101 degrees) after a third dose of DPT, at that time an ear infection was noted. WAES00121736 1
0178653 12/05/2001 CA 0.3 0 .3 F 11/26/2002 An 18 week old female was vaccinated with a second dose of Comvax IM on 24-JUN-1999 at 10 AM. Concomitant vaccinations that same day included the second dose of Rotasheild PO, the second dose of ACEL-IMUNE IM and the second dose of IPOL SQ. On 28-JUN-1999, the pt developed projectile vomiting, diarrhea and was inconsolable. It was noted that four and five days post vaccination, the pt developed a fever 101 F, vomiting, diarrhea and fussiness. The diarrhea was described as "foul, explosive mucoid green".The pt was reported to have gastroenteritis. The fussiness resolved after 3 weeks. Four weeks post-vaccination, the pt continued to have "green/mucous" stools. The diarrhea resolved after6 weeks. The pt was reported as recovered. Additional information ha been requested. This was originally reported by a physician. Upon follow up, the physician stated "I have had no adverse event." No further info is available. Y 06/24/1999 06/28/1999 4 A stool sample obtained after three weeks was positive for rotavirus antigens. PVT PVT NONE WAES00121977 1
0178654 12/05/2001 PA 0.5 0 .6 M 11/30/2001 Information has been received from a HCP concerning a 6 month old white male who on 05-JAN-2001 was vaccinated with a first dose of Comvax. Concomitant therapy included IPOL and Tripedia. On 05-JAN-2001 the pt developed a hard red lump in his thigh where Comvax was administered. Subsequently the pt recovered after 2 months. The reporter also reported that 6 other infants developed injection site pain, redness and swelling while vaccinated with Comvax. Additional information has been requested. Y 01/05/2001 01/05/2001 0 PVT PVT NONE WAES01012118 1
0178655 12/05/2001 IL 1.2 1 .2 F 11/30/2001 Information has been received from a RN concerning a 14 month old Hispanic female who was vaccinated in the right thigh with a third dose of Comvax on 05-DEC-2000. It was reported that the adverse reactions started 2 days after the injections, the pt's mother noticed a lump. On 07-DEC-2000, the reaction was 1.5 inches long induration by 1/2 inch wide. It was reported that the mother contacted the doctor one week after vaccination. On 08-JAN-2001 the pt was vaccinated with a fourth dose of Comvax in the left thigh. On 10-JAN-2001 the pt developed an induration 1/2 inch by 1/2 inch and fever of 100.8. It was reported that no pain at the site of injection was noted for either episode at the time of examination. the pt's outcome was reported as unknown. It was reported that 4 other pts had a similar reaction after exposure to Comvax. Additional information has been requested. Y U 12/05/2000 12/07/2000 2 Body temp 100.8 OTH OTH UNK UNK WAES01012377 1
0178656 12/05/2001 KY 0.25 0 .3 F 11/30/2001 Information has been received from a physician concerning a 13 week old white male who on 09-NOV-2000 was vaccinated IM with a dose of Comvax. On 09-NOV-2000, the pt developed a knot which appeared on injection site several hours after it was administered with no redness and no fever, Subsequently, the pt recovered from the event. Additional information has been requested. Y 11/09/2000 11/09/2000 0 NONE OTH OTH NONE UNK WAES01020582 1
0178657 12/05/2001 2.0 M 11/30/2001 This report concerns a 24 month old male who on 01-DEC-2000 was vaccinated with a dose of Comvax. Concomitant therapy included a dose of Infanrix. On 01-DEC-2001 the pt experienced moderately severe pain at an unspecified site and fever. The next day, he recovered, with out treatment. the reporter considered the pt's experiences to be related to Infanrix administration. No further information is available. Y 12/01/2000 12/01/2000 0 UNK OTH OTH UNK WAES01020603 1
0178658 12/05/2001 KY 1.0 1 .0 M 11/30/2001 Information has been received from a HCP concerning a 12 month old male who on 27-OCT-2000 was vaccinated with Comvax IM in the right thigh. On 27-OCT-2000 the pt experienced small knot at the injection site. He developed no other symptoms, however the knot remained for five weeks. Additional information has been requested. Y 10/27/2000 10/27/2000 0 PUB PVT UNK UNK WAES01030369 1
0178659 12/05/2001 MD 0.2 0 .2 F 11/30/2001 Information has been received from a certified MA concerning an 8 week old female who was vaccinated IM in the right thigh with a first dose of Comvax on 09-NOV-2000. On 09-NOV-2000, soon after receiving the vaccination, the pt experienced a knot at the injection site. The pt developed no other symptoms. The knot was still present when 4 month exam was performed on 10-JAN-2001. Subsequently, the pt recovered. No further information is available. Y 11/09/2000 11/09/2000 0 NONE PVT PUB UNK NONE WAES01030374 1
0178660 12/05/2001 IL 0.3 0 .4 M 11/30/2001 Information has been received from a RN concerning a 4 month old male pt who on 19-DEC-2000 was vaccinated in the left thigh with a second dose of Comvax. Subsequently, the pt developed a small knot under the injection site. it was reported that 4 other pts had a similar experience following exposure to Comvax. Follow up information has been received from a RN which states the parents did not report the lump and bruise at the injection site until the child's next visit to the doctor in approximately February 2001. The onset of the reaction is unknown. The pt has recovered. Y 12/19/2000 PVT PVT UNK UNK WAES01031056 1
0178661 12/05/2001 IL 0.3 0 .4 F 11/30/2001 Information has been received from a RN concerning a 19 week old Hispanic female who on 03-FEB-2001 was vaccinated with a second dose in the right thigh of Comvax. On 04-FEB-2001, the pt developed a lump at the injection site. It was reported that the lump was still observable 3 weeks later. On an unknown date the pt recovered. it was noted that the pt had no prior adverse reactions. It was reported that 4 other pts had similar experiences following exposure to Comvax. Y 02/03/2001 02/04/2001 1 PVT PVT NONE NONE WAES01031057 1
0178662 12/05/2001 IL U 11/30/2001 Information has been received from a RN concerning and unidentifiable pt who in approximately February 2001, was vaccinated with a dose of Comvax. Subsequently the pt developed a small knot under the injection site. It was reported that the knot has not resolved yet. Unspecified medical attention was sought. it was reported that 4 other pts had a similar experience following exposure to Comvax. Additional information has been requested. Y N 02/01/2001 02/01/2001 0 OTH OTH UNK UNK WAES01031058 1
0178663 12/05/2001 NJ 1.0 1 .0 F 11/30/2001 Information has been received from a RN concerning a 12 month old Hispanic and Black female who was vaccinated on 15-JAN-2001 IM in the right leg with a third dose of Comvax. Subsequently the pt developed a small knot under the injection site. It was reported that the knot has not resolved yet. Unspecified medical attention was sought. it was reported that 4 other pts had a similar experience following exposure to Comvax. Follow up information has been received from a RN which stated that the child developed a lump and bruise at the site which was still present 12 days later. The lump was "the size of a pea". No intervention was needed and pt recovered. Y Y 01/15/2001 01/16/2001 1 NONE PVT PUB UNK NONE WAES01031059 1
0178664 12/05/2001 OR 0.25 M 11/30/2001 Information has been received from a male consumer concerning his 3 month old son with no past medical history and no known allergies who, in approx. 2001, was vaccinated with a dose of haemophilus b conjugate vaccine (+) hepatitis b vaccine recombinant (yeast). Concomitant vaccine therapy included diphtheria, poliovirus vaccine and other "required vaccinations". The child's parent was not certain as to what vaccines were given. According to the parent, within hours of receiving the vaccinations, the child started crying much more than usual and was also "spitting up more". The baby also seemed to be experiencing flu-like symptoms which were not subsiding. Additional information has been requested. U OTH OTH NONE NONE NONE WAES01034236 1
0178665 12/05/2001 NY 1.4 1 .5 F 11/30/2001 Information has been received from a health professional concerning a 17 month old white female with no known allergies who on 4/25/01, at 14:40, was vaccinated, IM, in the left arm with a 1st dose of haemophilus b conjugate vaccine (+) hepatitis b vaccine recombinant (yeast) (lot 639075/1826K). There was no concomitant medication. There was no illness at the time of vaccination. On 4/26/01, the pt developed a 2" by 3" red, firm and somewhat tender lump surrounded by 1" of redness. On an unknown date the pt recovered. No further information is expected. Y 04/25/2001 04/26/2001 1 NONE PVT PVT NONE NONE NONE WAES01042859 1
0178666 12/05/2001 NY 0.8 F 11/26/2002 Information has been received from a physician concerning a 10 month old female who was vaccinated with haemophilus b conjugate vaccine (+) hepatitis b vaccine recombinant (yeast) (site not reported). Concomitantly, the pt was vaccinated with diphtheria toxoid/pertussis vaccine/teta (Infanrix) and poliovirus vaccine inactivated (mfr unknown). Subsequently, the pt experienced hives and difficulty in breathing. The pt was treated at the ER and released. No further details were provided. Additional information has been requested. The follow up states an allergy evaluation was performed on the pt, and upon workup, the physician was able to narrow down the pt's problems to be possibly due to the Tetanus component of the vaccine Infanrix. It was noted that hospital records have not been received from the hospital that treated the pt. Additional info has been requested. Y U OTH OTH UNK WAES01051122 1
0178667 12/05/2001 PA 0.75 0 .5 F 11/26/2002 Information has been received from an RN concerning a 9 month old white female with no known medical history or allergies who was vaccinated, IM, with a 1st dose, given in the left thigh, and a 2nd dose, given in the right thigh, of haemophilus b conjugate vaccine (+) hepatitis b vaccine recombinant (yeast) on 10/25/00 and 1/3/01 (lot 637201/1036K), respectively. Concomitant vaccination on the same days included a 1st dose, in the right thigh and a 2nd dose (lot 434301), in the left thigh of diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid (Acel-Immune), given IM. There was no illness noted at the time of vaccination. On 4/9/01, the pt developed a lump with purulent discharge at the injection site in the left leg. The lump was 1.5cm by 2.0cm in size. On 5/16/01, the pt developed a lump in the right leg that was 0.5cm. Neither lump had redness or tenderness. It was reported that the pt's lumps were still present. No further information is available. Follow up info indicated that the pt takes "NaFl gtts .25 qd." It was reported that the pt subsequently recovered. No further info is available. Y 01/03/2001 04/09/2001 96 PVT PVT NONE NONE NONE WAES01051884 1
0178668 12/05/2001 NE 0.3 0 .3 F 11/26/2002 Information has been received from a physician concerning a 4 month old female with no past medical history and no known drug allergies who on 8/22/01 was vaccinated with haemophilus b conjugate vaccine (+) hepatitis b vaccine recombinant (yeast). Concomitant medications included 4 other vaccines from other pharmaceutical companies. Within 24 hours, the pt had petechiae on her extremities. Unspecified medical attention was sought. No further information was provided. Additional information has been requested. The follow up states within 24 hrs the pt had petechiae on her lower extremities, away from the site of the injection, on both legs. The site of the injections was without swelling, petechia or erythema. The pt was considered recovered. Unspecified medical attention was sought. No other info is expected. Y Y 08/22/2001 08/23/2001 1 Hemoglobin 11.7gm/dl 8/24/01; platelet count 512 8/24/01; red blood cell count 3.82 8/24/01; WBC count 4.6 8/24/01; hematocrit 34% 8/24/01 PVT OTH Gastro-esophageal reflux disease, pylorospasm WAES01092355 1
0178669 12/05/2001 NM 1.0 0 1 M 11/27/2001 MMR, Varivax and IPV given 10/08/2001. Pt developed urticaria, facial swelling and trouble breathing at home several hours later. EMS called. EMS brought Pt to ER. Pt give epinephrine, prednisone and Benadryl. In ER pt breathing "fine", still had periorbital swelling and urticaria. Y Y 10/08/2001 10/08/2001 0 NONE PVT PVT NONE NONE History of febrile seizures 1
0178670 12/05/2001 AR 44.0 44 F Four days after receiving MMR pt complained of "colitis", unable to eat, no vomiting, no diarrhea but states passed bloody mucus per rectum. Seen in ER Y U 11/13/2001 11/16/2001 3 PPD-neg OTH PVT 1
0178671 12/05/2001 AR 1.0 1 .0 M 10/29/2001 Immunizations were given on 10/26/01 at 14:00. On 10/27/01 at 14:30, the child experienced a seizure while in the grocery store with his grandmother. The child had a temperature of 102F that Tylenol was Tylenol was being given for. The child was seen by ER and released home. Y Y 10/26/2001 10/27/2001 1 PUB PUB NONE NONE The child's mom had childhood seizures. AR0146 1
0178672 12/05/2001 AR 1.8 1 .9 M 09/11/2001 On 09/02/2001 Morning after immunization right upper arm red and swollen, redness and swelling steadily increasing during the day and not hot to touch. Woke up 09/05/2001 with a few widespread maculopapular areas. No temp but mom has been alternating between Tylenol and Advil since day of immunization. On 09/06/2001 AM right arm now swollen to fingers and mom took child to MD who started pt on Zyrtec and though that possibly was allergic type reaction to DTaP. Y Y 09/04/2001 09/05/2001 1 NONE PUB PUB Singulair Asthma and allergies Asthma AR0145 1
0178673 12/05/2001 MO 50.0 50 M 12/01/2001 The patient experienced elevated blood pressure (150/98) lasting several days and multiple and ongoing occurrences of heartbeat irregularity (PVC's) per day. Y U 10/30/2001 11/01/2001 2 Heart stress, ultrasound, holter monitor and blood tests. UNK PVT NONE NONE 1
0178674 12/05/2001 MD 1.08 1 .1 M 11/30/2001 The day following the vax the patient's temperature was 101F. The patient was treated with Tylenol. When taken to day care taker, it was noted the patient's eyes were rolling back in his head. 911 was called an arrived within 2 minutes. The seizure lasted less than 30 seconds. There was no seizure activity when the ambulance arrived. Upon examination at the ER the patient was alert and had no further seizures. On 11/27/2001 the patient had a temperature of 102.5-103F. There was no seizure activity. The patient was given a dose of amoxicillin and discharged. Y Y 11/26/2001 11/27/2001 1 WBC = wnl PVT PVT NONE Right otitis media. Born at 35 weeks. 1
0178675 12/05/2001 FL 56.0 56 M 11/30/2001 The patient experienced diarrhea 2 hours after the immunization and dizziness 2 days later. Y 10/23/2001 10/23/2001 0 OTH OTH NONE NONE NONE 1
0178676 12/05/2001 NH 5.0 1 .3 M 11/28/2001 On 11/27/2001 the patient developed several papules, firm vesicles, scattered over his body, on his face, back and groin area. The patient was exposed to chicken pox 2 weeks ago. U 03/18/1997 11/27/2001 1715 NONE PVT PUB NONE NONE 1
0178677 12/05/2001 WA 0.2 0 .2 F 11/21/2001 The patient experienced prolonged crying and screaming 3-4 hours. The patient was partially consolable. Y 09/28/2001 09/28/2001 0 NONE PVT PUB NONE NONE NONE 1
0178678 12/05/2001 IL 4.0 4 M 11/30/2001 The patient experienced a large local allergic reaction from the injection site in the left deltoid to mid forearm with erythema and swelling. The symptoms were similar to bee sting reaction. Y 11/28/2001 11/29/2001 1 PVT PVT NONE NONE NONE 1
0178679 12/05/2001 SD 1.2 1 .0 F 11/28/2001 Pt was given Varivax on 9/28/01. Pt seen at clinic 11/27/01 with rash that appeared to be chicken pox. Y U 09/28/2001 11/27/2001 60 PVT PUB 1
0178680 12/05/2001 PA M 11/30/2001 Pt developed a rash of varicella lesions. U 01/12/2000 PVT PVT 1
0178681 12/05/2001 NC 0.75 0 .8 M 11/27/2001 Pt had no problems until redness began at vaccine site on the morning of 11/26/01. Initially it was one red spot about 1 cm in diameter, but by the end of the day, there were 5-7 separate red spots close together. By the morning of 11/27, spots had merged into one lesion, red, slightly raised and warm, 5.3 x 2.8 cm. Pt's physical was otherwise nml. No Rx was prescribed at that time. Y U 11/19/2001 11/26/2001 7 PVT PUB NONE NONE NONE 1
0178682 12/05/2001 CA 6.0 6 F 11/28/2001 Pt developed a localized reaction at site of injection about 2 cm in size. Pt had fever and minimal tongue thrusting. She was treated with Children's Tylenol and Benadryl. Pt to follow-up in 24 hrs. Y Y 11/27/2001 11/27/2001 0 PVT PUB NONE NONE Congenital cerebellar dysfunction stabilized at 3 months of age 1
0178683 12/05/2001 CA 4.0 4 F 11/27/2001 Almost 2/3 of pt's right upper arm became edematous and indurated with erythema, warmth to the touch and pain. She had a severe localized reaction to DaPT. She was treated with Prelone, ice and elevation. Y Y 11/19/2001 11/21/2001 2 NONE PVT PVT NONE NONE NONE 1
0178684 12/05/2001 UT 44.0 44 F 12/03/2001 About 45 minutes post vax, pt developed swelling of the throat and difficulty swallowing. She became lightheaded and had nasal stuffiness. This lasted about 1 hour. She waited it out, and it went away. Y 11/30/2001 11/30/2001 0 OTH PUB Allegra, Prilosec, Entex LA NONE Pollen allergy 1
0178685 12/05/2001 GA 9.0 2 .5 M 12/03/2001 Pt had 20+ lesions on trunk and top of head. Y Y 05/10/1995 11/30/2001 2396 PVT PVT 1
0178686 12/06/2001 IL 43.0 43 F 01/09/2002 It was reported that a 43 year old female pt rec'd a Fluzone SV "00-01" vaccination on 12/5/00. Pt developed flu like symptoms (aches, congested and continuous fever). On 12/7/00 the pt was seen in the physician's office. Physician prescribed antibiotics for a week and the symptoms never resolved. The pt began to vomit frequently,. On 12/19/00 she was admitted to the hospital (St Mary's in St Louis). Pt was hospitalized for 3 wks and is now on dialysis 3 times a week. The pt is the reporter and did not believe that her physician ever reported this event. From follow up correspondence received from 1/8/02 the pt's medical history was provided. No further info is anticipated for this report. This case is closed. Y Y 21 U 12/05/2000 12/07/2000 2 UNK UNK Allergic rhinitis U2001012100 1
0178687 12/06/2001 OH 21.0 21 F 12/03/2001 It was reported that a 21 year old female pt received Menomune A/C/Y/W-135 vaccination administered on 30-OCT-2001. Approximately 4 days after vaccination the pt developed ringing in her ears. She was seen by general practitioner no infection was found. Pt was also seen by ENT specialist, a hearing test was done, results, significant amount of hearing loss noted. Pt to be seen by MD for evaluation, date of appointment not specified. Y U 10/30/2001 11/03/2001 4 UNK UNK U2001012140 1
0178688 12/06/2001 DE 18.0 18 F 11/29/2001 On 11/28/01 at 12:30, the pt was seen at a local ER. Right upper arm with 2 punctures with red lesion at area around injection site. Pt was treated with antibiotics and stayed overnight. Y Y 2 Y 11/26/2001 11/28/2001 2 MRI of upper right arm-showed cellulitis below the skin; WBC-24.1; BP-decreased; Resp-increased MIL MIL Pt had 2.5mg Albuterol nebulizer that morning Asthma 1
0178689 12/06/2001 SC 18.0 18 M 11/26/2001 Tightness in chest, SOB, wheezing and weakness after more than 20 minutes from receiving immunizations. Pt treated with SQ Epi, Solu medrol 125 and Benadryl 50 mg IV and Albuterol med treatment for 3 days. Y Y Y 11/26/2001 11/26/2001 0 MIL MIL NONE NONE 1
0178690 12/06/2001 NJ 90.0 90 F 11/21/2001 Pt awoke 11/15/2001 with hives over entire body. Eyes swollen with "feeling of sand in eye" check out "itchy" feeling. Therapy in ER 11/17/01 with Benadryl 25 mg BID and Prednisone 20 mg BID times 3 days. 11/21/2001 rash "clear" and "feeling well". Y Y 11/13/2001 11/15/2001 2 PUB PVT Prilosec, synthroic, Diabeta, Zoloft NONE CHF, hiatus hernia NJ200124 1
0178691 12/06/2001 VA 57.0 57 M 11/29/2001 Redness, swelling at site of Flu shot, painful to impact, low grade, 99 degree temperature, site is warm to touch approximately 3" diameter. Coworker slapped site of shot the next morning. Y U 11/26/2001 11/27/2001 1 OTH OTH glyburide, ibuprofen NONE Diabetic 1
0178692 12/06/2001 MD 29.0 29 F 11/27/2001 The pt developed dyspnea and wheezing, 10 minutes, post vax. She received IV epinephrine in the ambulance. 25 minutes later, symptoms of airway tightening ceased. No further treatment required. Did not have her inhaler prescription with her. Follow up 10/07/2002: "It was reported that patient developed dyspnea and wheezing 10 minute post vaccination. Vital signs were stable. Patient received Epinephrine IV in the ambulance. Symptoms of airway tightening ceased 25 minutes later. No further treatments required. Patient didn't have her inhaler with her at the time. Seriousness Criteria: Medically Significant." Y Y 11/02/2001 11/02/2001 0 NONE OTH OTH PRN inhaler, Zoloft 50 mg/day getting over viral symptoms Asthma, hay fever, animal alergies 1
0178693 12/06/2001 WI 32.0 32 F 11/06/2001 Flu vaccine given 10/05/01, came in 11/5/01 - Check out tenderness, pain at injection site. Area noted to be red/indurated. Y 10/05/2001 PVT PVT Glucophage Diovan, Zestril NONE Allergic to PCN only. 1
0178694 12/06/2001 CA 9.0 9 M 11/19/2001 Reports raised area around injection site 2 1/2"x 3" in diameter. No skin discoloration, no redness or heat. U 11/19/2001 11/19/2001 0 PVT PVT NONE Allergic to nectarine, dust mitte, berude and rve grass. 1
0178695 12/06/2001 OK 82.0 82 F 11/30/2001 TC from client reporting 2 "quarter size" erythema places at Flu ing site. Feels well - no other problems reported. Y 11/27/2001 11/30/2001 3 PUB UNK 1
0178696 12/06/2001 TN 45.0 45 F 11/19/2001 Nauseated, diarrhea, vomiting. Y 11/02/2001 11/02/2001 0 OTH UNK 1
0178697 12/06/2001 TX F 10/23/2001 Site of injection red and swollen, approximately 2 cm. Y 10/09/2001 10/09/2001 0 PUB OTH 1
0178698 12/06/2001 MD 44.0 44 M 11/27/2001 Chills, shaking, sweating, muscle aching. Y 11/05/2001 11/06/2001 1 OTH OTH Zoloft NONE Occasional Depression 1
0178699 12/06/2001 TX 50.0 50 F 11/12/2001 Pt states next day after injections of Flu vaccine and pneumo vac had 105 degree fever orally, did not go to ER or call provider. Each day thereafter fever decreased and local reaction at site of injection, left arm redness and swelling per patient. Pt states recovered completely. Pt stated had chills and sweating also. Y 10/31/2001 11/01/2001 1 PUB UNK NONE RSO, Hypertension, COPD 1
0178700 12/06/2001 NJ 1.0 1 .5 F 11/21/2001 Left eye only crossing over on the evening of the vaccine administration. Mom stated she had a slight temperature by touch. No other symptoms noted. Y N 11/13/2001 11/13/2001 0 PUB PVT NJ200125 1
0178701 12/06/2001 TX 2.0 2 .0 M 11/21/2001 The patient experienced swelling and redness in an area the size of a silver dollar on his thigh. The area was hot to touch. Y 11/19/2001 11/20/2001 1 NONE PVT PVT NONE NONE 1
0178702 12/06/2001 OR 70.0 F 11/30/2001 After each vaccination, the patient had flu-like symptoms for 3-4 hours. In the spring of 1997, the patient experienced an onset of bilateral knee pain and stiffness symptoms that are still present. The dates of vaccination were 04/10/1997, 05/06/1997 and 04/13/1998. N PUB UNK Synthroid NONE NONE 1
0178703 12/06/2001 OR 74.0 M 11/30/2001 Starting in the late spring of 1997, the patient began to experience lower back pain, intermittent swollen fingers, knee pain, stiffness in the joints, fatigue and adult asthma. These symptoms are still present. The patient is being treated for asthma. The dates of vaccination are 04/10/1997, 05/06/1997 and 04/13/1998. N PUB UNK NONE NONE NONE 1
0178704 12/06/2001 PA 49.0 46 F 12/03/2001 The patient experienced extreme fatigue, severe flu-like symptoms, achiness, painful joints and a fever. N 04/01/1999 04/02/1999 1 OTH OTH Birth Control Pills. NONE 1
0178705 12/06/2001 NY 42.0 40 F 11/20/2001 Within 2 weeks post vax, the patient became very ill. The patient started to show signs of Lymes disease. The patient developed aches and pains, a loss of energy and flu-like symptoms were quite severe. Y N 07/15/1999 Tested positive for Lyme disease. PVT OTH NONE NONE NONE 1
0178706 12/06/2001 VA 7.0 1 .1 F 11/30/2001 On 11/27/2001 the patient developed a small, pimple like rash with clear centers on her back, scalp and arms. The patient experienced itching and a temperature of 100.5F. The patient was treated with Benadryl and Aveeno and baking soda baths. Y 08/31/1995 11/27/2001 2280 PVT UNK 1
0178707 12/06/2001 ME 77.0 77 F 11/30/2001 Pt's arm red and swollen from shoulder to elbow. Warm to touch. Prednisone tapes given. Y 10/29/2001 10/30/2001 1 PVT PVT Relafen, Buspan and Renerde NONE Arthralgias anxiety, depressed 1
0178708 12/06/2001 NE 1.08 1 .1 M 11/29/2001 Developed rash, mostly trunk and fever. Was seen at Clinic. Y Y 11/12/2001 11/21/2001 9 OTH UNK Children's Motrin PRN NONE NONE 1
0178709 12/06/2001 OK 66.0 66 M 11/30/2001 Fever developed during the evening of 11/21/2001. It was over 103 the afternoon of the 11/22/2001. Family took pt to ER, but did not want to wait the 4 hours it would be before seeing the doctor. Pt's daughter gave alcohol rubs (she's an RN) and managed to break the fever. On 11/22/2001 left upper arm swollen, hot to touch. Pt recovered by 11/24/2001. Y 11/21/2001 11/21/2001 0 PVT PVT Zocor, Vioxx, HCTZ and Celebrex HTN, Hyperlipidemia, osteoarthritis 1
0178710 12/06/2001 OR 41 F 11/26/2001 Severe edema, local heat, tenderness in site of administration , in excess of expected and usual reaction. No treatment. Y Y 10/23/2001 10/23/2001 0 NONE PVT PVT Zoloft NONE Depression and Post spleenectomy 1
0178711 12/06/2001 ME 66.0 66 M 11/30/2001 Right arm red approximately 8 cm around injection site. Y 11/07/2001 11/08/2001 1 PVT PVT Zantac, Cozaar, Actonel and Simua ASVD, PVD, ASCVD 1
0178712 12/06/2001 TX 4.0 4 M 11/16/2001 Left arm red, hot, swollen. Shot given 11/14/2001. Came to clinic 11/16/2001. MD recommended him to take Benadryl and cold compresses. Y 11/14/2001 11/16/2001 2 PVT PUB NONE NKDA TX01177 1
0178713 12/06/2001 PA 15.0 11 M 11/28/2001 Pt vaccinated with Varivax on 04/04/1997. Erupted in chicken pox of 11/26/2001. Y 04/04/1997 11/26/2001 1697 NONE PVT PVT UNK NONE NONE 1
0178714 12/06/2001 SC 1.5 1 .5 M 12/04/2001 Hives 15 minutes after immunization. Y 12/04/2001 12/04/2001 0 NONE PVT PVT NONE NONE 1
0178718 12/07/2001 UT 0.16 0 .2 F 03/19/2002 A pediatrician reported that a 2 month old female received a dose of Prevnar, DTaP, Comvax and IPV vaccines on 27-SEP-2001. On 14-OCT-2001, at the age of three months, the child was found apneic. Resuscitation measures were performed by the child's mother and by emergency personnel prior to transporting the child to a local ER where she was pronounced dead. Bacterial CSF and blood and viral culture samples yielded negative results. An autopsy returned inconclusive but sudden infant death syndrome was possible. This report of a serious, labeled event is being submitted in a 15-day time frame as requested by the FDA. COD as per autopsy report -- undetermined. Follow-up info from a physician stated that her practice, "did not have any concerns regarding the haemophilus b conjugate vaccine hepatitis b vaccine recombinant. Additional info from a nurse in the physician's office stated that this pt, who was previously healthy, received haemophilus b conjugate vaccine hepatitis b vaccine recombinant. Additional info from a nurse in the physician's office stated that another infant (WAES 0203USA00661) also received Hib + Hep-B (lot 638216/1539K) and Prevnar and died of SIDS. The physician's office reported that they did not believe there was any association with Hib + Hep-B, but that both infants received the same lot of Prevnar. This report was also received from the Center for Biologics and Evaluation and Research and was assigned Vaers Id 180019. F/U info noted that there was no illness at the time of vaccination. The pt died of apparent SIDS, 2 1/2 weeks, post vax. The autopsy report was SIDS vs. anphyxia. The reporter listed the cause of death as SIDS. No further information is available. The follow up info received on 12/30/02 indicated that the pt's birth weight was 4 lbs 15 oz, it was also reported that the pt was a "second twin," had hyyperglycemia, hyperbilirubinemia and was premature at 35 weeks gestation. No further info is available. Follow up on 10/20/2003: "This report was received from Wyeth Ayerst for streptococcus pneumoniae vaccine (Prevnar) and assigned manufacturer report number HQ9063604DEC2001 (also noted to be HQ9063504NOV2001, HQ7304118OCT2001 & HQ0646611FEB2002). This report is concerning a 10 week old female." A 15-day report received 10/24/2003 adds no new info. Y 10/14/2001 Y N 09/27/2001 10/14/2001 17 CFS culture-neg, Blood culture-neg, Culture NOS-neg, Autopsy results-SIDS vs. Asphyxia; WBC-3,000 PVT OTH UNK NONE Premature baby, poor weight gain WAES0201USA00430 1
0178719 12/07/2001 NJ 39.0 40 F 11/30/2001 I developed flu like symptoms after 3rd dose of Lymerix and then developed severe joint and muscle pain and neck stiffness, blurry vision, light headedness, difficulty thinking and concentrating, mood swings, sleep problems, photophobia, rashes, sensitivity to sand, stomach problems, diarrhea from 06/10/2000 to present. Unable to work for six months Per 1 year follow up: pt has not recovered. I still continue to have fatigue, muscle and joint pain, severe neck pain and stiffness, memory loss, mood swings, headaches, diarrhea and constipation, numbeness to face and extremities, lightheadedness, facial rashes, swollen lyph nodes, teeth pain, decreased sense of taste, intermittent heart palpitations. Y Y N 04/12/2000 04/13/2000 1 HLA-DR4 (-); (+) Babesiosis IgM and IgG 1:40; PCR (+); IgB Ehrlichiosis-1:160; IgM Ehrlichiosis-1:80; Western Blot- (+) PVT PVT Lyme Disease Lyme Disease 1
0178725 12/07/2001 CA 43.0 42 F 11/27/2001 Red sore and swollen left arm area reported to ES on 11/21/01. Treated for cellulitis left arm within hours after 500 mg by mouth. Cold at forearm 11/27/01 pt reports finished medication and No problems. Y Y 11/19/2001 11/21/2001 2 UNK UNK 1
0178726 12/07/2001 NJ 44.0 44 M 12/03/2001 Check out"feeling dizzy", blurring vision, blood pressure systolic=80 (Pre Vaccine B/P 142/92). Slight chest pressure. Epinephrine ADM, 911 notified, transported to RWJ, evaluated and discharged. Y Y 11/21/2001 11/21/2001 0 OTH OTH Epinephrine NONE Denied, Reference Consent Form 1
0178727 12/07/2001 PA 58.0 58 F 12/13/2001 Pain, swelling in upper arm. Pain, numbness in left 5th finger (1 day after injection. Still persisting on day four. N 11/29/2001 11/30/2001 1 PVT PVT Premarin, Prevacid NONE None except arthritis, lumbar spine 1
0178728 12/07/2001 PA 38.0 38 F 11/30/2001 Right leg weakness, pain, tingling in right foot. Physical therapy started and continues to present time. Symptoms continue. Y N 10/18/2001 10/26/2001 8 PVT OTH Vioxx, Robaxin, Darvon 100 NONE Celiac disease, Codeine, Percodan, Sulfa drug, allerged. 1
0178729 12/07/2001 WI 55.0 55 F 11/26/2001 At 1700, 11/09/01, Left arm , feet, hand and 30" later knee circle around arm then red and swollen, also chills times 2 days after within one eprsoal diarrhea, (amps). U 11/09/2001 11/09/2001 0 PVT OTH Multi Pie, tegretal, tylenal, iburafen, barium, amitriptyeline, seafood NONE Multipie also cramp x 1 Rt/LT foot. tah, BSO nervous- R/o anxiety, possible COPD(1995) HTN 1
0178730 12/07/2001 CT 0.8 0 .4 F 11/29/2001 On exam (routine) 11/27/01 mother reported to MD that child "screamed, fussy for " up to 6 hours within last DtaP injection on 08/24/01, and upon further thought, felt child was extremely fussy with 2nd DtaP on 07/11/01 although did not report to office at those time, I will elect to use Ped DT in future. Y 07/11/2001 11/11/2001 123 PVT PVT NONE HHO Respiratory distress in neo natal percocet (first 26 degree Cipro) 1
0178731 12/07/2001 GA 1.0 1 .5 F 12/03/2001 Evening hours, after receiving immunization on 11/30/01. 18 month old client was taken to CR Hospital in Dahlonega for check out pain in joint and fever 102 was seen by PMD. Ruled out Flu "probably DTAP" per clients guardian. Y Y 11/30/2001 11/30/2001 0 PUB PVT NONE NONE 1
0178732 12/07/2001 WY 0.2 0 .2 F 10/10/2001 Two month old female baby for immunizations. Baby's skin color is slightly pale. Baby crying, threw up, difficulty breathing. RN noted emesis on the exam table consisted of moderate amount of thick clear mucous with a small amount of light red liquid consistent with the liquid infant Tylenol. Baby very lethargic, extremities flaccid, and responding slowly to painful stimuli. Oxygen applied at 4 liters by blow-by. Y Y 10/10/2001 10/10/2001 0 NONE PUB PVT Tylenol, Oxygen Mother of child reported that child had apnea birth 02 for IM 1
0178733 12/07/2001 KS 1.0 1 .0 M 11/29/2001 Vesicular "spot" left lateral thigh likely site of Varicella Vaccine 11/16/01. Y 11/16/2001 11/25/2001 9 PVT PVT 1
0178734 12/07/2001 CT 1.0 1 .3 M 12/06/2001 Rash, fever, contracted measles from vaccine. Y Y 09/25/2000 PVT OTH NONE-had been sick weeks before NONE 1
0178735 12/07/2001 NY 70.0 70 F 11/28/2001 Pt called complaining of large local reaction with redness, swelling and pain. Benadryl and ice that night. 11/16/2001 swollen arm from shoulder to elbow, 2 pack of medroldone. Y Y 11/14/2001 11/14/2001 0 PVT PVT Zestril and H chlorochiozide NONE NKDA, HTN and arthritis 1
0178736 12/07/2001 NY 43.0 43 F 11/28/2001 Pt seen at ER complained of red, swollen left arm with pain that evening and saw MD in our office in follow up on 11/12/2001. Y Y 11/09/2001 11/09/2001 0 PVT PVT HRT, Levinsex and Depakote NONE Penicillin and erythremycin 1
0178737 12/07/2001 RI 45.0 44 F 12/04/2001 Pt immediately after TD vaccination to right deltoid began to develop progressive deltoid pain and tenderness and ultimate inability to raise right arm above shoulder. N 08/19/2001 08/19/2001 0 X-ray right shoulder-wnl OTH OTH NONE NONE 1
0178738 12/07/2001 NE 10.0 10 F 11/16/2001 Developed low grade reaction 24 hours following Hep B and MMR immunization. Reaction consisted of headache, flushed face and fever ranging from 99 to 100.9. Pt's mother reported she began to feel better on the evening of 11/09/2001. Y 11/06/2001 11/07/2001 1 NONE PUB PUB Sore Throat NE016 1
0178739 12/07/2001 NC 1.0 1 .0 F 11/28/2001 10 days after vaccine varicella type lesions appeared on stomach, back, face and bottom. Approximately 15 lesions. Low grade fever persisted times 2 days. Given Benadryl-2 doses on day lesions appeared. Infant Motrin given BID times 3 days. Lesions and fever resolved 11/28/01. Y 11/15/2001 11/25/2001 10 PVT PVT Benadryl-2, Motrin 1
0178740 12/07/2001 CA 1.5 1 .9 M 11/14/2001 Mother of pt called and said 2 days post vaccinations child's left leg was red, warm, tender and swelling. Comparable to half dollar size of coin. Denies crying or fever and afebrile. Y 10/31/2001 11/02/2001 2 NONE PUB OTH NONE NONE NONE 1
0178741 12/07/2001 VA 53.0 53 F 12/04/2001 On 11/29/2001 experienced nausea. On 11/30/2001 was nausea, headache and slight fever with aches and pains. Also right deltoid swelled with hives 1 inch by 3 inches. On 12/01/2001 hive enlarged to 2 inches by 3 inches. Decreased nausea but had headache with aches and pains in evening only. On 12/02/2001 hives 4 by 6 inches on right deltoid, headache but symptoms improving. Y 11/29/2001 11/29/2001 0 NONE OTH OTH NONE NONE Heart Murmur 1
0178742 12/07/2001 FL 7.0 1 .0 F 11/28/2001 URI followed by papular vesicular eruption for 2 days. U 05/22/1995 11/26/2001 2380 PVT UNK URI 1
0178743 12/07/2001 FL 0.2 0 .2 M 11/30/2001 Pt developed hives all over body. Approximately more prominent around DTaP site. No distress. Y 11/27/2001 11/29/2001 2 NONE PVT PUB NONE NONE NONE 1
0178744 12/07/2001 MI 4.0 4 M 11/30/2001 Cellulitis left thigh. Keflex 250 mg TID for 10 days, warm soaks and Benadryl PO q 4-6 hours. Y N 11/21/2001 NONE PVT PVT NONE Cough NONE 1
0178745 12/07/2001 MS 1.9 1 .9 M 11/30/2001 Pt had shots 11/08/2001. On 11/15/2001 at 4 PM pt had slight temp. Mom gave Tylenol. About 7:40 pt went unconscious, then began to shake uncontrollably. 911 called during seizure. Ambulance checked temp 104. Mom states when seizure started child did not have fever. ER MD diagnosed as febrile seizure. Y Y 11/08/2001 11/15/2001 7 PUB PUB MS01052 1
0178746 12/07/2001 FL 4.0 4 M 12/03/2001 Swollen eyelids. Claritin Reditabs given and Prelone 20 mg day PO. Y 12/03/2001 12/03/2001 0 PVT PUB NONE Asthma Prevnar, V2V allergies ~Pneumo (Prevnar)~1~3.00~In Patient 1
0178747 12/07/2001 MI 0.5 0 .5 M Shaking, generalized spells lasting 2-3 minutes, 1-2 times per day, normal after and between spells ever since 10/19/2001. U 10/19/2001 10/20/2001 1 EEG 10/31/2001 (was cancelled by parents) PVT PUB Mild aortic stenosis and ASD 1
0178748 12/07/2001 MN 4.0 4 M 11/30/2001 Swelling, erythema and warmth 4.5 inch diameter on arm. U 11/28/2001 11/29/2001 1 NONE PVT UNK NONE Amoxicillin ~DTaP (no brand name)~~0.00~In Sibling 1
0178749 12/07/2001 NY 1.0 1 .0 M 12/03/2001 Call from Mom 11/28/2001 8 days after injections. Mom reports two lumps left leg described as "knots" or lumps at injection site. Mom called again 12/04/2001 one lump described as a boil without a head remains left leg also child congested with fever on/off since 11/20/2001. U 11/20/2001 11/21/2001 1 PUB PUB NONE NONE 1
0178750 12/07/2001 NY 10.0 9 F 12/31/2001 Approximately 2 by 2 inch rash developed at site left deltoid 24 hours after injection. Site was red, warm and hard. U 11/29/2001 11/30/2001 1 OTH PUB NONE Lactose intolerant, egg allergy, red dye and all "cillins". rash~Measles + Mumps + Rubella (no brand name)~~0.00~In Patient 1
0178751 12/07/2001 RI 18.0 18 F 12/06/2001 Vaccine administered 12/04/2001. Student claims injection site became reddened and intensely itchy the evening of 12/04/2001. Presented with area right upper arm 2 inches in diameter red, raised, warm to touch. Diffuse red area around this also complained of itching. 12/04/2001 12/04/2001 0 OTH PUB NONE UNK 1
0178752 12/07/2001 GA 1.75 1 .8 F 12/03/2001 Rash all over body and fever. U 11/20/2001 11/29/2001 9 PVT PUB 1
0178753 12/07/2001 62.0 F Pt reported swelling and redness to right arm within 3 hours of receiving Pneumonia vaccine. Pt went to own physician 11/16/2001, received antibiotics. Y 11/15/2001 11/15/2001 0 UNK UNK History of surgery to right shoulder (rotator cuff). 1
0178754 12/07/2001 IL 49.0 49 F 11/28/2001 Pt complained of tightness in throat and throat "feeling funny." Y 11/23/2001 11/23/2001 0 NONE OTH PVT Tequin Asthma 1
0178755 12/07/2001 NE 15.0 15 F 11/16/2001 On 11/05/2001 pt saw physician for tendonitis. Given ibuprofen 600mg. On 11/06/2001 had 1st hep B dose about 3:30 PM. On 11/07/2001 pt reports itching prior to bed. On 11/08/2001 mother obtained Benadryl 25 mg, gave the pt some. Pt continued to take ibuprofen and a drug (minocycline) for acne. On 11/11/2001 noon mother informed nurse that pt was itching all night. Told to increase Benadryl to 50 mg and consult physician if not improved by tomorrow. On 11/12/2001 pt saw physician who thought she had developed hepatitis. He stopped all medication and sent her back to school. On 11/13/2001 pt saw pediatrician. Pediatrician did numerous tests, placed pt on bedrest and told mother he thought she may have Hepatitis A and this probably had nothing to do with immunizations. Live enzymes markedly elevated from results obtained. Immunization nurse called to follow up with mother on how pt was feeling and was given this information. On 11/14/2001 pt returned for results of blood test. Tests were negative for hepatitis. Further tests will be done on 11/16/2001. More blood tests and a MRI were done on 11/16/2001. Results are not known at this time. Mother was informed that I am filling out this form. On 11/19/2001 no results from test to date. mother will sign release of information form so the doctor will send test results to school nurse. Y U 11/06/2001 11/07/2001 1 Liver enzymes, Bilirubin, MRI PUB PUB Minocycline and ibuprofen 600 mg TID Tendonitis and acne NE017 1
0178756 12/10/2001 PA 0.2 0 .2 F 12/03/2001 Infant given 2 month immunizations on Friday 11/30/2001. Monday 12/03/2001 infant was found dead in crib. Paramedics called and were unable to resuscitate. Medical examiner called. Autopsy pending. COD as per autopsy report -- SIDS Y 12/03/2001 N 11/30/2001 12/03/2001 3 Autopsy pending PVT PUB NONE NONE Prematurity 31 weeks. Post gestational age 39 weeks. 1
0178757 12/10/2001 NC 0.2 0 .2 M 11/29/2001 Pt found asystolic at approximately 2 AM in his crib on 11/29/2001. COD as per autopsy report --SIDS/sr Y 11/29/2001 N 11/28/2001 11/29/2001 1 Post mortem exam PVT PUB NONE NONE NONE 1
0178758 12/10/2001 OH 0.5 0 .5 F 11/28/2001 Had immunizations on 11/27/2001. Woke 11/28/2001 in AM with 104.3 rectal temp. Mom heard baby shaking in swing and saw eyes roll back. Baby thrashing around, arching jerky movements. Lasted 1 minute. Y Y Y 11/27/2001 11/28/2001 1 PUB PUB Tylenol on 11/27/01 at 19:00 and on 11/28/01 at 02:00 and 09:00 NONE Premature at 32 weeks; Constipation 1
0178759 12/10/2001 OR 59.0 58 M 11/19/2001 Pt got the flu shot on 11/2/01. "A couple of days later", he felt joint aches and was "feeling bad". On 11/13/01 at 14:00, he began to feel numbness and tingling in his feet and hands. Also was losing coordination. GBS? Still in ICU. 60 day follow-up information states on 1/21/03 T.V. with medical RN and client.l Under care of neurologist for GBS which occurred 2 weeks after flu vaccine 11/2/01. On Soc Sec because uncalbe to return to job as machinist. Able to ambulate now without care. Very fatigued/no stamina, feet hypersensitive and sore; numbness and tingling in fingers and left side of face and forehead. Discharge summary states GBS, sepsis, and URI. Follow up on 11/04/2003: "Vaccine recipient did not recover from the adverse event. See attached updated report based on 10/30/2003. Telephoned client regarding her present health states and treatment." Y Y 60 U 11/02/2001 11/13/2001 11 CSF fluid with increased protein. OTH PVT NONE Discharge summary indicates pt has history of smoking/tobacco addiction. OR200147 1
0178760 12/10/2001 NY 63.0 63 M 11/28/2001 Received flu vaccine on 11/16/2001. One hour and a half later began sweating, swelling in armpit (size of baseball), shaking, no pain, indigestion, weakness, laying on floor. Called doctor 3 hours after receiving vaccine was in hospital for heart attack. Y 11 Y 11/16/2001 11/16/2001 0 PUB PUB Allergy shots NONE Allergies: mold, spores, dust and animals 1
0178761 12/10/2001 CA 1.0 1 .0 M 12/03/2001 Pt developed ITP with a platelet count of 6,000 and petechia and purpura. He was hospitalized for 24 hours and treated with IVIG with good response. Platelet count was 42,000 on 11/30/01. Per 1 year follow up: pt recovered. No additional comments. Y 1 U 11/15/2001 11/29/2001 14 NONE PVT PVT NONE Platelet count 6,000 URI (no fever) 1
0178762 12/10/2001 UT 33.0 33 M 11/15/2001 Patient accidently received anthrax vaccine 5 months sooner than he was suppose to, no reported adverse effects up to this point 11/15/01. Y 11/14/2001 MIL MIL 1
0178763 12/10/2001 77.0 77 F The pt received the influenza vaccine on 11/3/98 and 11/4/00 without incidence. The pt was dx'd with breast cancer in 1980, which is currently in remission. For the treatment of this cancer, the pt has for years been taking raloxifene Hydrochloride and megestrol acetate orally on a po basis. The pt has also, for an unspecified period, been taking hydrochlorthiazide orally on a PO QD basis, for the treatment of hypertension. On 11/20/01, the pt experienced constriction of the mouth and difficulty swallowing. On 11/21/01, the pt was seen by a physician, was dx'd with Bell's Palsy and Prednisone was prescribed with some improvement. On 11/27/01, the pt was seen by her regular physician for follow-up. The dx of Bell's Palsy was again confirmed as the pt presented with lip drooping, however, swallowing had improved. Prednisone for an additional 2 weeks, was prescribed. The reporter has assessed the relationship of Fluvirin to the event as possible. This was considered to be an "Other Important Medical Event". U 10/30/2001 11/20/2001 21 UNK UNK E-vista; Megace; Dyazide Breast cancer in 1980 PJP2001004360 1
0178764 12/10/2001 IL 35.0 M 11/27/2001 2 1/2 hours after receiving Adult Hep B + Influenza Vaccine at work developed chest pain, flushing, nausea and increased heart rate. Sent to Freeport Hospital ER. All tests were normal. Y Y 11/12/2001 11/12/2001 0 PUB PVT 1
0178765 12/10/2001 KS 58.0 58 F 11/12/2001 Pt called 7 days within flu shot voiced that she had a rash all over her body. Y 11/08/2001 11/08/2001 0 PUB OTH Actos 15 mg QD, Accupil 10 mg QD Feline 1
0178766 12/10/2001 F 11/30/2001 Hospital employee received routine influenza vaccine immediately started swelling with red rash. Y Y 11/26/2001 UNK UNK 1
0178767 12/10/2001 IA 65.0 65 F 11/30/2001 About 5 hours after shot, arm hot and arm hot to touc. By the next day pt had 4" circumference of redness, swelling, hot and itchy. Today area of redness has decreased to about 3" redness. Says she has reacted to flu shots other years. Currently gets allergy shots from Clinic in Cedar Rapids. Sometimes reacts to those. Y 11/27/2001 11/27/2001 0 OTH PVT NONE NONE Taking allergy shots; Diabetes 1
0178768 12/10/2001 WI 60.0 60 M 12/03/2001 3rd cranial nerve palsy to L eye. Drooping lid. Burning eye, socket pain - severe. Watery eye. Seen by 5 ophthalmologist no treatment. Prognosis 3-6 months with 100% return of eye function & sight. Also have distorted vision that causes nausea. Y 7 Y 10/12/2001 10/22/2001 10 MRI OTH OTH Prilosec, ASA, insulin NONE Diabetes 1
0178769 12/10/2001 NY 54.0 54 F 12/03/2001 Received shot and W/H KeD to intake area my whole arm became numb, I felt dizzy and sat down, I felt faint and put my head on the desk. I started sweating, shaking and my heart started racing. When I started to come out of it, I felt weak, tired and shaky. I went home and slept for 2-3 hours took Advil for aches and headache behind my eye. Y 11/30/2001 11/30/2001 0 PUB PVT Avalide, Atenolol NONE Hypertension 1
0178770 12/10/2001 OK 68.0 68 F 11/30/2001 11/30/01 telephone call from pt saying that she began to get a rash the evening of 11/27/01 the day she got her flu and pneumonia shots. The rash is now all over her body and is itchy. She also reports erythema at the injection site. Has had several flu shots in past without problems. Advised to contact private physician re anti pruritic. U 11/27/2001 11/27/2001 0 PUB PUB 1
0178771 12/10/2001 TX 60.0 F 10/23/2001 Arm very sore and red Y NONE PUB OTH Premarin 1
0178772 12/10/2001 OH 23.0 23 F 11/29/2001 Pt states that at 9pm 11/28/01 she broke out in hives, which started at the injection site & spread all over her body. By 11pm she was itching all over. At 2am 11/29/01 she put cortisone cream & alcohol on for relief of itching. Presented to H.D. at 1:45pm 11/29/01.No rash at present has had flu vaccine x last 5 yrs annually. Y Y 11/28/2001 11/28/2001 0 PUB PUB NONE NONE 1
0178773 12/10/2001 PA 33.0 33 F 12/04/2001 Severe pain, induration erythema myalgias localized left UE +shoulder +chest pain, mild pruritis. Pain swelling extended from deltoid to pectoral trapezius axillary distrubtion, lymphadenopathy within 24 hours Y 11/29/2001 11/29/2001 0 NONE PVT PVT NONE NONE Aspirin Allergy,Asthma 1
0178774 12/10/2001 SC 33.0 33 F 11/30/2001 Soreness injection site, fever 102, 5:30-6 PM took two Goody Powders. Muscle aches up and down arm, joint pain left arm numbness and tingling fingertips developed night of injection and next day. 11/30/2001 symptom free. Y 11/28/2001 11/28/2001 0 NONE OTH PUB BCP Healthy SC0160 1
0178775 12/10/2001 SC 43.0 43 F 11/30/2001 One hour after flu shot given developed burning in throat, reacted to BA did not report until 12/21/2000. 11/19/2001 came for flu shot, states tongue also swelled, difficulty after flu shot 12/2000. no flu shot give 11/2001. Y 12/01/2000 12/01/2000 0 NONE OTH PUB NONE Allergy: penecillin, sulfa, mutt foods and latex SC0162 1
0178776 12/10/2001 OR 22.0 22 F 12/04/2001 Red welt developed. 4.5 cm by 6 cm, No treatment administered. Y 11/20/2001 11/22/2001 2 NONE PVT PVT NONE NONE NONE 1
0178777 12/10/2001 DC 44.0 44 F 12/06/2001 Pt received flu vaccine about 2 weeks ago, in the right deltoid. The deltoid pain began about 24 hours, post vax. In the past 2-3 days, she had increased pain, limited use of her shoulder, arm and hand. No erythema, inflammation, induration, masses or lesions. Positive abduction was limited to 45 degrees. Treatment: conservative; ibuprofen and cold therapy. Return if signs and symptoms increase or persist over 5-7 days. U 11/19/2001 11/20/2001 1 NONE OTH PUB NONE NONE Allergy to aspirin; history of anemia (1996) 1
0178778 12/10/2001 PA 41.0 41 F 11/28/2001 Pt is having progressive numbness and weakness of left side of body including her tongue. Pt has been sent to neurologist. There is concern the pt may have Guillain Barre. Pt is in the process of treatment. FU on 12/3 from MD states pt is somewhat anxious and has some give away weakness in her legs as well as astasia abasia when walking. Will start her on steriods and ask her to come back in after getting test results. Diagnosed with acute disseminated encephalomyelitis Y N 11/14/2001 11/16/2001 2 MRI done on 12/3/01; cervical spine MRI 12/4/01. OTH OTH OTC Estroven MSAN Allergic to PCN 1
0178779 12/10/2001 UT 55.0 55 M 11/13/2001 Nerve pain associated with area where flut shot given. Sharp, prickly pain when use arm when lifting. Pain lasted for about 3 weeks. Took ibuprofen 600 mg intermittently. Y 10/24/2001 10/24/2001 0 OTH PVT Adalat, Amaryl, Toprol, Zocor and Zestoretic NONE Diabetes and high blood pressure 1
0178780 12/10/2001 TX 50.0 50 F 11/29/2001 Redness at site with edema and warm to touch X 2-3 days. Dizziness for 10 minutes, post vax. Rash at site X 3 days with itching. Complete recovery. Y 11/09/2001 11/09/2001 0 PVT PVT E-Vista; HRT NONE Allergy to Vicodin 1
0178781 12/10/2001 FL 39.0 39 F 12/04/2001 Vaccine administered into top of arm at shoulder location. Extreme pain radiating into and down the arm. Doctor said it possibly hit the bone and/or nerve. Improperly given. Y N 12/04/2001 12/04/2001 0 OTH UNK NONE 1
0178782 12/10/2001 IL 81.0 81 F 11/27/2001 States day after immunization arm very sore and swollen. remains painful, teking Tylenol every two time a day. Talked to nurse at MD's office. Told to use warm compresses. Pain (2 weeks later) from site of immunization to elbow. 10/30/2001 10/31/2001 1 PUB PUB Premarin, Synthroid, Verapamil, Liptor and Imdur NONE Heart problems, high thyroid and high cholesterol. 1
0178783 12/10/2001 OR 23.0 23 M 11/14/2001 10 minutes, post vax, the pt reported vision changes, weakness, shakiness but was coherent and oriented. He then became diaphoretic, pale and required assistance from local EMT's. He was transported to the local hospital and given fluids. He recovered. Y Y 11/09/2001 11/09/2001 0 NONE OTH PUB NONE NONE NONE OR200148 1
0178784 12/10/2001 TX 39.0 39 F Pt developed pain at the injection site. It was raised, red with chills and glands swollen X 5 days. Resolved now. Y 11/09/2001 11/10/2001 1 PVT PVT Lodine 600mg; Synthroid; OC's NONE Thyroid failure 1
0178785 12/10/2001 SC 69.0 69 F 11/15/2001 Second arm felt sore Sunday. Six days later pt states felt tightness around muscle. Pt describes light red circle around muscle 10 day later. Pt also states pain extended down arm and into back and neck. Pt states will see private MD on 11/17/2001 for evaluation. Red circle nickel size around injection site today. Pt took 5 days of Amoxicillin. Y 10/29/2001 10/30/2001 1 PUB UNK Arthritis, scoliosis, pulled chest muscle 1
0178786 12/10/2001 NJ 1.2 1 .2 F 09/19/2001 The pt developed small, red dots all over her trunk and face. No fever. This lasted 3 days. No treatment. Y 08/24/2001 08/31/2001 7 NONE PUB PUB NONE NONE NONE NJ200126 1
0178787 12/10/2001 OH 1.6 1 .6 F 11/28/2001 Pt developed increased temperature of 102F; local cellulitis approx. 2" X 2". Treated with ceftriaxone 600mg X 2 and given Augmentin X 8 days. Y Y 11/16/2001 11/18/2001 2 CBC Diff; CRP; Blood Cultures-all neg PVT PVT NONE NONE NONE 1
0178788 12/10/2001 MI 1.25 1 .3 U Fever 104 13 hours after vaccination. DTaP, Hib, PCV and Varivax. Simple febrile seizure ensued. Y 11/28/2001 11/29/2001 1 Had blood culture and CXR. PVT UNK Topical hydrocortisone NONE Eczema 1
0178789 12/10/2001 IN 1.25 0 1 M 12/04/2001 The 1st reaction was on 8/13/01 with vomiting, red and flushed face, legs and arms and lethargy which lasted 45 minutes. The 2nd reaction was on 11/14/01, post vax of Comvax and Varivax, with lethargy and broke out in hives which lasted over an hour. Gave him 1/4 tsp of Benadryl. Y 08/13/2001 08/13/2001 0 PVT OTH NONE 1
0178790 12/10/2001 CT 0.2 0 .2 M 11/30/2001 The morning after DTaP, HIB, IPV, Prevnar #1 pt's whole body was swollen per parents. No other symptoms. Resolved next AM. Not seen by MD. Y 09/27/2001 09/28/2001 1 PVT UNK NONE Large frenulum clipped secondary to poor feeding, hypotonia and poor feeding resolved no gentic workup. 1
0178791 12/10/2001 IN M 11/28/2001 Recent problem with cellulitis of leg prior to receiving 2nd Lymerix. Two days after vaccination, developed fever and confusion. Taken to ED, cultured and given IV fluid. Started on antibiotics. Y Y 05/14/2001 05/16/2001 2 WBC 30,000 with left shift OTH PUB Cellulitis 1
0178792 12/10/2001 VA 62.0 60 M Flu like symptoms, pains hands and feet, blood shot eyes, low grade fever, fatigue, night sweats, joint pain, dry eyes, poor grip. Pressure on chest and throat. Y N 12/01/1999 02/01/2000 62 PVT PVT NONE NONE NONE 1
0178793 12/10/2001 55.0 55 M 11/28/2001 The pt was given 1 dose of pneumovax 23 valent on 11/26/01. (The pt claims this was the 1st time he had ever received this). On 11/28/01, the pt presents with a swollen, red, enlarged, rash on arm at the injection site. U 11/26/2001 11/28/2001 2 OTH OTH Type II Diabetes Mellitus; Asthma 1
0178794 12/10/2001 UT 0.2 0 .2 M 11/12/2001 Mother reports that the pt was very upset, post vax. When he finally settled down and went to sleep, he had some myoclonic jerks. He also had a fever (not measured). Immunizations given on 8/20/01. Y 08/20/2001 08/20/2001 0 NONE PUB PUB NONE NONE UT011823 1
0178795 12/10/2001 UT 48.0 47 F 11/19/2001 Right upper arm muscle hard, painful. Enlarged lymph nodes under right arm and right side of neck. Upper right arm 1 cm larger than left arm. Decreased range of motion in right arm. Y U 09/13/2001 09/13/2001 0 Ultrasound to rule out blood clot. PUB PVT Dilantin and phenobarbital NONE Seizure disorder d/t encephalitis from case of flu in 1968 and ulcerative colitis 1995. swelling in right arm~DT Adsorbed (no brand name)~~17.00~In Patient UT012522 1
0178796 12/10/2001 IL 10.0 10 F 11/21/2001 Immediately following vaccination, the pt collapsed to the floor. She was pale, had a slight stiffness to her extremities (right arm), eyes rolled back and hit her face on the side of the desk. She was only "out" for a very few seconds and was talking but appeared dazed. No history of fainting in the past. She had been very apprehensive before the shot was given. Mom was advised to take her to the doctor but it was not done. Y 11/16/2001 11/16/2001 0 PUB PUB NONE NONE NONE 1
0178797 12/10/2001 OH 13.0 13 F 11/27/2001 On 11/25/01, had puffy and itchy eyes which spread to hives on trunk on 11/27/01. On 11/27/01, was seen by MD and prescribed Cortisone pills, saying reaction to Hep-B shot. Y Y 11/20/2001 11/25/2001 5 PUB PUB NONE NONE Sulfa drugs allergy OH0068 1
0178798 12/10/2001 DC 56.0 56 F 11/19/2001 3 days post 1st Pneumovax vaccination local reaction consisting of 11x18cm red, indurated warm area at site of vaccination (L triceps). no fever, chills, etc. Y 11/16/2001 11/18/2001 2 NONE MIL MIL Crohns Dz (stable) 1
0178799 12/10/2001 AR 0.2 0 .2 F 11/02/2001 Adopted infant with no known hlth problems brought in clinic for 1st immunizations, 1 1/2-2hrs following vaccine child had high pitched cry that lasted for 2-3hrs. No fever or seizure activity, lasted for 2-3 hrs. No fever or seizure activity. Parent had gone thru similar experience w. another adopted child who ??? Y 11/01/2001 11/01/2001 0 N/A PUB PUB NONE NONE NONE AR0147 1
0178800 12/10/2001 OR 4.0 4 M 11/14/2001 Child developed erythema and induration (area measuring greater than 50 mm) at injection site for DTaP. Did not show this to mother until 6 days after injection. Non-tender, warm to touch. No fever, seizures noted. Y Y 11/07/2001 11/12/2001 5 PUB PUB NONE NONE NONE OR200149 1
0178801 12/10/2001 NC 2.0 2 .5 F 11/28/2001 Pt had 2 by 3 bruise, 4 by 6 area of induration. Physician's assessment- local reaction to immunization. No treatment. Y Y 11/26/2001 11/26/2001 0 NONE PUB PUB NONE Otitis Media Eye cellulitis on 09/01/2001 NC01103 1
0178802 12/10/2001 MN 1.25 1 .3 M 12/03/2001 The day after shots, parents noticed redness, swelling and warmth around shots. Seen in office, 2 days after shots with a 4cm area of erythema surrounding injection sites, warm to touch and raised up. This resolved 3 days after shots. Also had a low-grade temperature of 99.5F and irritability, which all resolved. Y 11/27/2001 11/28/2001 1 NONE PVT PVT NONE NONE 1
0178803 12/10/2001 FL 4.0 4 F MOC called 10:25 AM on 11/29/2001 to report that child had local reaction on left anterior thigh site of DTaP, erythema, warmth, induration "about as wide as a racquetball" (approxiamately 5 cm). No fever. Active/playing. Advised warm compresses, ibuprofen ok (given by MOC). Y 11/27/2001 11/29/2001 2 Three positive proteinuria on day immunization PVT PVT NONE NONE NKDA 1
0178804 12/10/2001 TX 4.0 4 M 12/03/2001 The pt returned to the office for swelling of left thigh and difficulty walking. On exam, the left leg was swollen from his hip to his knee and firm. He limped with ambulation. No redness or fever. He was treated with Augmentin. Y 11/29/2001 11/30/2001 1 CBC; Blood Culture PVT PVT NONE Congestion 1
0178805 12/10/2001 PA 2.0 1 .0 M 12/03/2001 Pt developed a mild chickenpox eruption. U 03/07/2000 11/30/2001 633 PVT OTH 1
0178806 12/10/2001 NY 64.0 64 M 12/04/2001 Pt developed redness, warmth and swelling of left upper extremity to forearm. No temperature. Rx'd Keflex 500mg po qid X 10 days. Y Y 11/30/2001 12/02/2001 2 PVT OTH Lipitor NONE Hypercholesterolemia 1
0178807 12/10/2001 SC 64.0 64 M 11/30/2001 7 PM night of injection whole right shoulder was throbbing, shooting tingles down back from shoulder blade, unsteady on feet, took Tylenol with some relief. Next day much better. Still taking Tylenol, still having muscle soreness as of 11/30/2001. Y 11/15/2001 11/15/2001 0 NONE OTH PUB Azulfidine, folic alert herb NONE High blood pressure SC0161 1
0178808 12/10/2001 FL 1.08 1 .1 M 11/29/2001 Pt developed a local reaction at site which was a red, hot to touch and indurated area on thigh. This began the day after immunizations. It was worse on the 2nd day, then was better. Y Y 11/26/2001 11/27/2001 1 MIL MIL Flovent; Albuterol; Robitussin; Prednisone; Augmentin NONE RAD 1
0178809 12/10/2001 OH 1.5 1 .5 M 11/29/2001 Pt had swelling and redness 3.5 cm by 3.5 cm around injection site left thigh one day after DTaP dose 4 was administered. Y 11/27/2001 11/28/2001 1 NONE PVT PUB NONE NONE 1
0178810 12/10/2001 IL 76.0 76 F 11/16/2001 Client experienced pain in left arm with onset 3-4 hours after receiving vaccination. She stated the pain started at the vaccination site and progressed down the arm to the wrist. She describes the pain as "intense". She denies any redness, bruising or swelling. Follow up phone call on 11/28/2001 client states pain is almost gone. She has some pain at injection site when lifting something. Denies any numbness or tingling of extremity. 11/02/2001 11/02/2001 0 NONE PUB PVT UNK NONE No Allergies 1
0178811 12/10/2001 KY 28.0 27 F 12/03/2001 Immediately upon withdrawal of the needle from her arm, the employee complained of feeling sick and nauseated. The employee became very pale/diaphoretic and cool with episodes of syncope and tachycardia. The employee also complained of severe pain in extremities, related to violent muscle cramping. 50mg of IV Benadryl was given. Y Y 11/19/2001 11/19/2001 0 PUB PUB NONE 1
0178812 12/10/2001 MA 4.0 4 F 12/04/2001 Pt developed moderate swelling at the site of the injection. Y 11/29/2001 11/30/2001 1 NONE PVT PUB NONE NONE NONE Rash~Measles + Mumps + Rubella (no brand name)~1~2.00~In Patient 1
0178813 12/10/2001 MA 7.0 3 F 12/03/2001 Vaccine failure. Diagnosed with chicken pox 12/03/2001. 03/17/1998 12/03/2001 1357 Clinical diagnosis-classic skin rash PVT PUB NONE NONE UNK 1
0178814 12/10/2001 NY 1.0 1 .0 M 11/30/2001 3 hours, post vax, the pt had a fever that climbed to 103F-104F despite treatment with both Tylenol and Motrin which lasted about 12 hours. Y 11/29/2001 11/29/2001 0 MIL MIL NONE Viral syndrome; otitis NONE 1
0178815 12/10/2001 CA 4.0 4 F 12/03/2001 Right upper thigh skin graft raised warm 4 by 4 cm welt at injection site. 11/26/2001 11/27/2001 1 PVT UNK NONE Howser burn over 40% of body. 1
0178816 12/10/2001 NY 11.0 11 M 11/30/2001 Pt had full body rash, rash was red and raised at site of injection, their was a dime sized blister with a quarter sized area of redness around blister. Treatment: Prednisone for 10 days and Claritin for 10 days. No fever and no itchiness. Y Y 10/26/2001 10/27/2001 1 PT referred to allergist to rule out PCN allergy vs Hep B reaction. PUB OTH On Amoxicillin since 10/20/2001 Tooth infection NONE 1
0178817 12/10/2001 FL 6.0 M 12/05/2001 Five to fifteen lesions Y 02/12/1986 12/02/2001 5772 NONE PVT PVT NONE NONE NONE 1
0178818 12/10/2001 FL 6.0 F 12/05/2001 Fifty to seventy-five lesions for 2-3 days. Y 05/21/1986 12/02/2001 5674 NONE PVT PVT NONE NONE NONE 1
0178819 12/10/2001 IL 1.25 1 .3 F 12/01/2001 Fever deery first 24 hours ag=fter vaccine. Resolved over next 24 hours (2 doses of Tylenol given). Y 11/29/2001 PVT PUB 1
0178820 12/10/2001 IL 1.25 1 .3 F 12/01/2001 Pt developed redness and swelling (about 2cm X 2cm in diameter) around the site of Hib vaccination during the 1st 24 hours then resolved during the next 24 hours. No pain. Y 11/27/2001 11/27/2001 0 PVT PUB 1
0178821 12/11/2001 ME 0 .3 F 12/10/2001 On 11/15/01 at 01:00, pt was fed and laid on her back. At 03:00, checked baby and determined that she was not breathing. There was no response and no pulse. Called 911 and CRP was performed. Ambulance came and transported to the hospital. Y 11/15/2001 N 11/12/2001 11/15/2001 3 PVT PVT NONE NONE NONE 1
0178822 12/11/2001 MS 0.2 0 .2 M 12/03/2001 I was told that the mother placed him in his baby bed around 20:00. About an hour later, when she checked on him, he was not breathing. I was told he died at home. COD as per autopsy report -- SIDS Y 06/13/2001 N 06/13/2001 06/13/2001 0 PVT PUB NONE 1
0178823 12/11/2001 OH 2.0 2 .0 F 11/29/2001 The evening of 11/16/01, the child vomited X 1 and no other symptoms were present. The child died in her sleep that night. Cause of Death as per autopsy report was SIDS with focal epiglotitis. Y 11/17/2001 N 11/14/2001 11/17/2001 3 PUB PUB NONE NONE NONE OH0071 1
0178824 12/11/2001 CA 0.2 0 .2 M 05/23/2001 Possible SIDS. Mother found infant at 06:57 on 5/9/01, lying prone in his crib (stiff and cold). Paramedics responded to 911 call and pronounced the death. No trauma or injury found. Information obtained from Sheriff-Coroner's initial death report. Unable to contact mother. On 8/9/01, dx received from Deputy Coroner of blunt force traumatic injuries of torso. Y 05/09/2001 N 05/07/2001 05/09/2001 2 Autopsy pending PVT OTH NONE NONE 1
0178825 12/11/2001 19.0 F 12/04/2001 In March, April and September 1995, a 1st, 2nd and 3rd dose of Engerix-B were given. During the summer of 1995 (not known whether after the 2nd or the 3rd dose), this female pt gradually developed fatigue and malaise and was found to have a newly elevated erythrocyte sedimentation rate (Westergren) of 49mm/h in the absence of back pain or other symptoms of active ankylosing spondylitis from which she suffers since 1991. In 10/95, she developed severe headaches and was found to have blood pressure of 220/110 mmHg. She had never before has had hypertension and her blood pressure in 8/95 had been 116/70 mmHg. After starting Enalapril (Enalapril Maleate), she developed acute renal failure, prompting her admission to the hospital. Her exam was remarkable for hypertension, a left-side abdominal bruit and normal pulses in her extremities. Enalapril was discontinued upon hospital admission. Her renal recovery following emergent aortorenal sephenous vein grafts and pulse methylprednisolone has been reported. In 10/97, 90% stenosis of the right renal artery vein graft was treated successfully with angioplasty. At that time a slight stenosis of the mid portion of the right subclavian artery was noted. An MRI in 8/99 showed no further narrowing of the involved arteries. It is mentioned that the dx of Takayasu's arteritis fits well, as she was a young woman with angiographic abnormalties of the subclavian, celiac, superior mesenteria and renal arteries that are characteristic of Takayasu's. It was also mentioned that it is not possible to determine whether the large artery vasculitis in this pt was caused by the vaccination or simply temporally associated. The number of cases of vasculitis that have been reported following vaccination at least raises the possibility of a causal relationship. The underlying rheumatic diseases of both pts described in this article (ankylosing spondylitis for the present case and polymyalgia rheumation for the 2nd pt) suggests the possibility that the pt with immunologic dysfunction may be more susceptible to developing vasculitis following vaccination. Y Y 04/01/1995 ESR-55 mm/h; hematocrit value 35%; serum creatinine-6.0 mg/dl; UA-3+ proteinuria and 1-2 red blood cells per high power field; 24 hour urine for quantification of proteinuria was not obtained; Russell's viper venom time-wnl (20.9 s) and antioardiolipin IgG, IgM and IgA were neg; ANA, C3, C4, plasma renin, perinuclear antineutrophil cytoplasmic antibody (p-ANCA), cytoplasmic-ANCA (c-ANCA); hepatitis b surface antigen and hepatitis c antibody were nml or neg; rheumatoid factor and HLA-B27 serology were not obtained; Hep-B surface antibody was positive but no titer was obtained; angiography showed bilateral high grade renal artery stenosis and a large inferior mesenteric artery collateral and additional angiography revealed superior mesenteric and celiac artery stenosis with abdominal aortic thickening OTH OTH NSAID Ankylosing spondylitis; both parents hepatitis b carriers; lower back pain attributed to bilateral sacroiliitis from ankylosing spondylitis; an uncle has also ankylosing spondylitis 20010286201 1
0178826 12/11/2001 61.0 F 12/04/2001 In 9/97, a 1st dose of Engerix-B was given previous to a travel to India. At that time, the blood pressure was 110/70. Hep-B serologies were negative. The night following the 1st vaccination, this subject experienced fatigue, malaise and eye pain, which resolved over days. In 10/97, the 2nd dose of Engerix-B was given. Post vax, she rapidly developed fatigue as well as low-grade fevers, anorexia and headache. Over the next month, she experienced a weight loss of about 13.5 kg and by 11/97, she had developed hypertension (230/140). A retinal hemorrhage was noted. A rise in her serum creatinine to 2.8mg/dl prompted referral to the hospital. Exam in 2/98 showed blood pressure 140/104 in the right arm and 180/104 in the left arm. Bruits were noted over both axillary arteries, the left supraclavicular area, the left femoral artery and the abdomen. The right brachial and radial pulses were diminished. The serum creatinine was 2.8mg/dl and ESR 18mm/h. Angiography showed long bilateral subclavian stenosis with the right extending to the axillary artery. Bilateral selective renal angiogram in 11/98 showed evidence of arteritis in the small and large renal arteries. Despite being treated with prednisone and multiple immunosuppressive drugs including monthly pulse cyclophosphamide, her renal function continued to deteriorate and there was no change in the stenosis. Progressive renal failure was ascribed to her hypertension and underlying arteritis. Immunosuppressive therapy was discontinued in 6/99 and hemodialysis commenced 2 months later. She successfully underwent living related renal transplantation in 11/99. It is discussed that the above mentioned vasculitis in this pt also suggests Takayasu's arteritis. However, her advanced age and the sparing of other vessels would be unusual for Takayasu's. A dx of giant cell arteritis would fit her onset of disease after age 50 and the subclavian changes, which may occur in QCA in the absence of temporal artery involvement. However, QCA would not explain the bilateral renal artery disease this pt had. The underlying rheumatic disease of the pt in this article (polymyalgia rheumatica) suggests she possibility that a pt with immunologic dysfunction may be more susceptible to developing vasculitis following vaccination. Y U 10/01/1997 10/01/1997 0 UA-no red blood cells and 870mg of protein; BP-elevated; serum creatinine-2.8mg/dl and multiple other tests; left renal biopsy-changes of acute and chronic ischemia including acute tubular injury with parenchyma scarring and moderate to severe interstitial fibrosis and tubular atrophy OTH OTH Myalgia of shoulders and hips 1990 20010286401 1
0178834 12/11/2001 NJ 0.2 0 .2 M 11/29/2001 On 10/1/01 at 16:00, pt had a fever of 105F. He was admitted to the hospital. Pt was treated with IV antibiotics for 2 days. Dx'd with viral syndrome. Y Y 3 Y 09/28/2001 10/01/2001 3 Lab work; spinal tap and chest film-all wnl PUB PUB NONE Runny nose and cough NONE NJ200127 1
0178835 12/11/2001 MI 0.3 0 .3 M 12/03/2001 Four days after immunization infant started having multiple seizures and was admitted to hospital, started on anti seizure meds and was weaned off after about 5 months. Now off over a year and without seizures. Child's speech delayed, neurologist feels related to seizures and seizures related to DTaP. Doc 213706, states the following: Delay in speech development. Problem continued more than 1 year after immunization. Report was made 23 mo. after immunization Annual follow up report received 6/10/2003 adds: Date of vaccination was 1/4/2000, date of VAERS report 12/3/01, had been 1 year 11 months between vaccine and report. Symptoms were still present at that time. 4/4/03 phone call to mother revealed child's speech was still delayed, was enrolled in a PPI program and currently being evaluated for autism. A follow up report received on 6/23/2003 adds: Enclosed is a follow-up report to a VAERS report that I submitted on 12/03/2001. At that time, it had been 1 year 11 months since the child had received the vaccine. His mother was concerned the child was still having problems related to immunization. I contacted the mother again on 04/04/2003 for follow up (3 years, 4 months from vaccination date). She states child is no longer on seizure medication and has had no further seizure activity. He still has speech delays and is enrolled in a Pre-Primary Impaired program. He has an appointment to evaluate further for autism. She has chosen note to continue immunizations. Follow up on 10/31/2003: "Vaccine recipient did not recover from the adverse events. Date of vaccination was 01/04/2000. Date of VAERS report 12/03/2001. Had been 1 year 11 months between vaccine and report symptoms were still present at that time. 04/04/2003: Phone call to mother revealed child's speech was still delayed, was enrolled in a PPI program and currently being evaluated at hospital for autism." Y Y Y 18 Y Y N 01/04/2000 01/08/2000 4 CT, MRI and all other tests-wnl PUB PUB NONE NONE NONE MI2001095 1
0178836 12/11/2001 MN 48.0 46 F 12/06/2001 Upon waking, on 11/12/99, the pt experienced both legs "buckled" and had difficulty walking. Symptoms progressed by evening and was unable to stand. By the next day, she loss use of her arms and hands. Treatment (IV solution of platelet Ig concentrate) started immediately with some return of feeling in a week. Went to inpatient after 11 days in ICU. She is using walker. Fully recovered and back to work on 3/1/00. She felt "self again" in 5/01. Y Y 27 Y 10/12/1999 11/12/1999 31 PUB UNK NONE Polyneuritis/paralytic ileus NONE 1
0178837 12/11/2001 IL 71.0 72 F 12/05/2001 Reported pt diagnosed with Guillain-Barre syndrome. Per 1 year ago: Pt has not recovered. "Continues to be off-balance. Bottoms of my feet are painful and they tingle with my toes wanting to draw under. My hands still tingle." Y Y U 10/25/2001 12/01/2001 37 PUB PUB UNK 1
0178838 12/11/2001 PA 4.0 4 M 12/05/2001 Pt developed anaphylaxis, 5 minutes post vax. Y Y Y 12/05/2001 12/05/2001 0 PVT PUB PPD/Aventis/C0687AB/0 previously; Flovent; Albuterol S/P pneumonia (resolved); Asthma; GERD 1
0178839 12/11/2001 CT 44.0 43 M 12/04/2001 Pt developed immediate sore joints, extreme cognitive decline and depression. Within 1 week, he developed extreme fatigue. Within 1 month he had tingling of his arm, facial tics and an inflamed elbow with extreme pain. Poor cognitive function, no memory, joints hurt. Constantly "sick" since receiving the lyme vaccine. In April, May and June of 1999. Brain swelling. Cannot work. Y Y N 04/13/1999 04/14/1999 1 Brain Spect, Spinal Tap, 2 clinical diagnostic neurosychological exam. PUB PVT NONE 1
0178840 12/11/2001 IN 19.0 19 M 12/01/2001 First noted hives and itching on arms, face at 11:00 AM one hour after injection, reported to Clinic at 14:00 hours with above signs at symptoms reversible complained of SOB OR difficult breathing. Pt given one Claritin 10 mg by mouth. Pt states decreased S/J within 15 minutes with medication. Y 12/01/2001 12/01/2001 0 MIL MIL Claritin 1
0178841 12/11/2001 MI 86.0 86 M 12/03/2001 120x70 mm hematoma on right arm area. No soreness, no numbness or tingling of extremity area dark purple with yellowing with edges. To flu with pink in 1-2 days. Y 11/26/2001 12/01/2001 5 PUB PVT Blood pressure medication HTN MI2001094 1
0178842 12/11/2001 OH 39 F 12/04/2001 Check out swollen area on arm. 11/30/2001 12/03/2001 3 OTH PVT NONE NONE 1
0178843 12/11/2001 OH 70.0 70 F 12/03/2001 The pt complained of soreness, swelling and redness on left arm between elbow and upper arm the day after injections. Y 11/27/2001 11/28/2001 1 NONE OTH PUB NONE NONE NONE 1
0178844 12/11/2001 IL 59.0 59 F The pt complained of soreness at the site of the injection. She called on 12/31/01 and said that she had difficulty in raising her arm. She was vaccinated on 11/7/01. U 11/07/2001 11/09/2001 2 OTH PVT NONE NONE NONE 1
0178845 12/11/2001 WI 57.0 57 F 11/30/2001 11/1/01 pt reported having a light red rash all over her body. Dry rash. Y 10/28/2001 11/01/2001 4 NONE PUB PVT Claritin, Prilosec, inhalers, hormones cold 1 wk prior sulfa, animal dander, pollen, dust mites 1
0178846 12/11/2001 NC 50.0 50 F 11/27/2001 The pt experienced a syncopal episode about 15-20 minutes after flu shot and about 5 minutes after blood was drawn complicated by difficulty accessing vein X 3 attempts. The pt felt dizzy prior to episode. The event was attributed to vasovagal reaction. Y 11/05/2001 11/05/2001 0 NONE PVT PVT Salogen; Plaquenil; Augmentin; Excedrin Sjorgen's Syndrome UTI; Type II Herpes Simplex; Toxoplasmosis; Chronic HA 1
0178847 12/11/2001 MI 21.0 21 M 12/03/2001 Rash, itching muscle aches, fatigue. Y Y 11/29/2001 11/29/2001 0 OTH PVT NONE NONE 1
0178848 12/11/2001 MS 54.0 54 M 11/06/2001 The pt called the clinic on 11/6/01 and stated he "has had stiff neck and soreness of head and ears since 11/3/01. He states he has arthritis of neck and he was referred to PMD. Called PMD but the pt did not go. Then PMD's office called and stated the pt was seen on 11/3/01 with no complaints. Y U 11/02/2001 11/03/2001 1 PUB PUB NONE NONE MS01053 1
0178849 12/11/2001 CA 48.0 48 F 11/28/2001 11/28/01 @ 1:35 came in for swollen,painful L arm after flu shot. Ice packs and advil tabs po q 6 hrs, prn. 12/3/01 pt called, doing fine now. Y 11/07/2001 11/28/2001 21 NONE OTH OTH NONE asthma, migraine 1
0178850 12/11/2001 MD 31.0 31 F 12/04/2001 Stiff neck, 11/20/2001, 6PM, 9:00AM awaking 11/21/01 vasculitis lower extremity (legs), stiff neck, headache, cold, by 11/25/01 on forearms, buttocks, stomach, lower back, but spoatic, 11/29/01 3 painless ulcers in roof of mouth. Y Y 11/13/2001 11/20/2001 7 Blood test to rule out SLE. OTH OTH Elavil (25 mg) headache prevention, Levelin NONE NONE 1
0178851 12/11/2001 CA 1.4 1 .5 M 12/03/2001 Seven minute tonic-clonic seizure. No documented fever. Twin sibling has had 2 febrile seizures. Y Y 11/27/2001 11/29/2001 2 CBC-wnl, lytor, LP, head CT PVT PUB Resolving otits media 1
0178852 12/11/2001 HI 45.0 45 F 10/17/2001 Received influenza vaccine 10/15/2001 left upper arm. Same evening painful, warm to touch. Next day 10/16/2001 large reddened, hardened raised area 10/17/2001. Some reddened area not raised 2 inches in diameter. Took Tylenol. Y 10/15/2001 10/15/2001 0 NONE PUB PVT Premarin NONE Allergy-Bees 1
0178853 12/11/2001 NE 68.0 68 M Pt received vaccine on 10/24/2001 in AM. That evening pt experienced increased intestinal and bladder pressure for 2 days with chills, after which symptoms resolved. Y 10/24/2001 10/24/2001 0 NONE PUB PVT 1
0178854 12/11/2001 NH 61.0 61 M 12/03/2001 Received flu shot left deltoid 11/15/2001. On 12/03/2001 complained of weakness in arm, difficulty raising arm, decreased strength. Saw ARNP 11/26/2001. Treated with warm compress. NKA. On 12/06/2001 improved. Y Y 11/15/2001 11/26/2001 11 PUB PVT NONE NONE NONE 1
0178855 12/11/2001 NH 28.0 28 F 12/03/2001 Pt developed chest and throat tightness about 8 minutes after receiving flu vaccine. Epinephrine 0.3cc given. Y Y 11/29/2001 11/29/2001 0 PUB PVT NONE NONE 1
0178856 12/11/2001 OH 43.0 43 F Complained of red mark, hot area of upper arm, area is black and blue and swollen the size of a fist. Y 12/04/2001 NONE OTH PVT NONE NONE Esophageal reflux 1
0178857 12/11/2001 MI 4.0 4 F 11/30/2001 Cellulitis of left thigh. Benadryl PO q 4-6 hours. Keflex 250 mg TID for 7 days. Warm soaks. Y Y 11/26/2001 11/26/2001 0 NONE PVT PUB Takes Creon with meals NONE Cystic Fibrosis 1
0178858 12/11/2001 FL 45.0 45 F 12/05/2001 1:30 AM woke up nauseated, vomited, had diarrhea. Continued for 2 weeks. 11/15/2001 IV for dehydration-NS. Continues to be dizzy and complains of nausea. Y N 10/30/2001 10/31/2001 1 CBC-wnl; Comprehensive metaboli profile-wnl PVT PVT Multivitamin with iron NONE Blurred vision, dizzy spells. lesion, frequent headaches 1
0178859 12/11/2001 MI M 12/06/2001 Allergic dermatitis and flu-like symptoms. U 12/05/2001 12/06/2001 1 OTH PVT NONE NONE 1
0178860 12/11/2001 IL 75.0 M The pt presented to my office quite unexpectedly on 11/20/01 with complaints of worsening ecchymosis and bleeding from his mouth and nose. A stat CBC showed a platelet count of 8,000. Two weeks earlier, his platelets were stable at 68,000 while on Danocrine 200mg daily and prednisone, 5mg daily. In taking a history from the pt, the only thing new was the fact that he had received an influenza vaccination approx. 2 weeks earlier. What was quite fascinating was the fact that the day before, another pt of mine with a history of ITP, also presented to my office with a relapse of his disease 12-14 days after an influenza vaccination. I took the liberty of treating the pt with high dose IG IV, I raised his dose of prednisone, gave him 1 dose of Vincristine and 2 units of platelet transfusion because of his bleeding. On 11/27/01, his platelet count was still low at 6,000. He then received a dose of WinRho as an outpatient on 11/27/01. On 11/29/01, his platelets were still low. Test showed elevated Transaminases of uncertain etiology which could certainly be due to the Danocrine or to perhaps the WinRho. I will ask the pt to discontinue the Danocrine at this time and raised his prednisone to 80mg/day. Platelets were up to 40,000 on 12/3/01. In 17 years of practice, I have never seen this. This is considered to be an "Other Important Medical Event". Y Y 11/20/2001 Chronic ITP OTH OTH CBC-8,000 and 6,000 Chronic ITP 1
0178861 12/11/2001 OH 5.0 5 M 11/29/2001 Mother of child states 11/15 size of a dime large lump with redness developed on R arm at injection site. It continued to increase in size on 11/16 became very warm to touch 3 large half dollar size blotches were present. 11/17 began to resolve and now completely gone without further complications. Y 11/14/2001 11/15/2001 1 PUB PUB NONE NONE NONE OH0070 1
0178862 12/11/2001 NJ 1.9 1 1 F 12/07/2001 23 month old adopted from China on 10/00 with reliable government immunization records. On 12/4/01, at around 08:00, the pt had a 2 minute generalized seizure. This was a 1st time seizure. She was postictal for several hours in the ER. No other signs or symptoms. Afebrile. Y Y 12/03/2001 12/04/2001 1 Scheduled for EEG PVT PVT NONE NONE NONE 1
0178863 12/11/2001 VA 0.4 0 .4 M 12/06/2001 Pt started with a fever of 103F-104F on 12/3/01 and continues with a fever, fussiness and decreased activity. He saw doctor on 12/5/01 and was dx'd with "viral illness". He still is with increased temperature. Y N 12/03/2001 12/03/2001 0 NONE PUB PUB NONE NONE NONE 1
0178864 12/11/2001 IA 0.3 0 .3 F 12/04/2001 High pitched uncontrollable crying - 2 1/2 hrs, small reddened nodule on R anterior thigh. Y 12/03/2001 12/04/2001 1 CBC/Diff PVT PVT NONE cold NONE 1
0178865 12/11/2001 CA 2.0 2 .7 M 12/03/2001 Pt had redness, rash and a raised 5cm X 7cm macular rash medial to injection site. He was placed on oral Keflex for cellulitis. Y U 11/30/2001 11/30/2001 0 NONE PVT PVT NONE NONE 1
0178866 12/11/2001 FL 4.0 4 M 11/30/2001 Right area that itched around injection site. was 4x areas most of upper arm got pink, indurated and itched. Y 11/27/2001 11/27/2001 0 PUB PVT Polyradiculopathy, Zyrtec Allergic rhinitis Allergic rhinitis 1
0178867 12/11/2001 MO 63 F 12/04/2001 Shot given in L deltoid/ IM early AM. By 5pm arm 1" below shot site swollen, red, warm painful. Y Y 12/03/2001 12/03/2001 0 none PVT PVT servent inhaler PCN, Raxar, asthma, COPD 1
0178868 12/11/2001 MN 1.0 1 .0 M 12/05/2001 Pt developed a maculopapular, discreet rash on 12/04/2001. No fever or other symptoms. Y 11/26/2001 12/04/2001 8 PVT PVT NONE NONE 1
0178869 12/11/2001 MI 8.0 4 M 12/04/2001 Seen by primary care physician on 11/28/01. Diagnoses with atypical varicella. Trunk with erythemotous popular lesions with some scabs, few vesicles. U 11/25/1997 11/28/2001 1464 NONE PUB UNK 1
0178870 12/11/2001 FL 4.0 4 F 11/13/2001 (Size of adult palm) Red mark, hard, heat radiating from the area, sore to touch (within 36 hours of shots). Y Y 11/07/2001 11/09/2001 2 MIL MIL 1
0178871 12/11/2001 IA 1.0 1 .0 F 12/04/2001 On 12/03/2001, Mom noticed red dots around neck getting more spots. On 12/04/2001 more spots, more water killed, is itching at them. Seen by PA at another clinic. Y U 11/12/2001 12/03/2001 21 UNK PVT PVT NONE NONE 1
0178872 12/11/2001 SC 4.0 4 M 11/30/2001 Temperature 101.6, redness and swelling on left thigh. Swelling in left inguinal area. Y Y 11/27/2001 11/29/2001 2 PVT PVT Augmentin 400 mg BID for 7 days NONE NONE 1
0178873 12/11/2001 VA 1 .0 M 12/05/2001 Herpes zoster 11/29/2001 improved (tx Zovirax). Y Y 04/28/1997 11/29/2001 1676 NONE PVT UNK NONE NONE 1
0178874 12/11/2001 IL 5.0 5 M 11/28/2001 Swollen left thigh, non-tender, full range of motion, very itchy. Treatment: Benadryl PRN, cool compresses. Y Y 11/26/2001 11/27/2001 1 PVT PVT NONE Hydronephrosis 1
0178875 12/11/2001 TN 14.0 14 F 11/30/2001 Git weak, into a daze after HBV 32 given; felt weak no treatment given. Y 11/30/2001 11/30/2001 0 Blood Glucose 80 PVT PUB NONE NONE 1
0178876 12/11/2001 OH 1.13 1 .1 F 11/29/2001 Mother brought child into HD. Had runny nose, lacy rash over trunk of body moving up into back of hair on head. No obvious fever, temp not taken. Otherwise bright, active and happy. Advised to call personal physician. Taken to MD then to ER because of 100.6 fever that evening. ER diagnosed roseola and no vaccine reaction. 11/30/2001 spoke with mom, child much better. Was told to continue to get scheduled vaccines. Y Y 11/27/2001 11/28/2001 1 PUB PUB NONE NONE OH0069 1
0178878 12/11/2001 TX 2.0 1 .0 F 11/29/2001 Varivax given 10/10/2000 then pt seen 11/15/2001 with shingles on right buttock. Y Y 10/10/2000 11/15/2001 401 NONE PVT PVT NONE Strabismus 1
0178879 12/11/2001 FL 47.0 47 F 12/04/2001 Enlarged lymph nodes to the neck. Laterally and posteriarly also to the left axilla. Y Y 11/13/2001 11/27/2001 14 PVT UNK 1
0178880 12/11/2001 MA F 11/16/2001 Developed large inflamed area 10 in by 5 in. Put on Cipro 250 mg BID for 10 days. Y Y 11/13/2001 11/13/2001 0 PVT PUB NONE Rheumatoid arthritis 1
0178881 12/11/2001 SC 4.0 4 F 11/28/2001 Red hives 12/8/01 left shoulder, upper arm and shoulder, across back and lower back, back of neck,around both eyes were red also. Ref. to mom to take child to Prompt care. Y Y 11/27/2001 11/27/2001 0 PUB PVT NONE NONE NONE SC0163 1
0178882 12/11/2001 NY 1.0 1 .8 F 11/30/2001 Swelling of the thigh (Right) after vaccination. 11/06/2001 11/07/2001 1 Cellulitis of the thigh right Keflex. PVT PVT Tylenol 1
0178884 12/11/2001 FL 6.0 1 .0 F 11/29/2001 Broke out with chicken pox. Y Y 05/09/1996 11/28/2001 2029 PVT PVT 1
0178885 12/11/2001 TN 36.0 36 F 12/06/2001 Approximately, 15 minutes after receiving Td- Pt's chest became completely covered with raised rash with intense itching. Approximately 5 minutes later she complain of difficulty breathing. Y Y 12/06/2001 12/06/2001 0 PUB PVT Benadryl, Epinephrine Allergic to Keflex and Sulfa 1
0178886 12/11/2001 PA 7.0 0 1 F 12/06/2001 Pt had the varicella vaccine on 10/24/95. Pt was dx'd with chickenpox on 12/5/01. Possible immunization failure. Y Y 10/24/1995 12/05/2001 2234 PVT OTH 1
0178887 12/11/2001 MI 0.2 0 .1 M 12/04/2001 Red bumps on body some scabs. Y 11/28/2001 11/29/2001 1 PVT PVT 1
0178888 12/11/2001 PA 11.5 11 F 11/19/2001 Student received IM injection of Hepatitis B vaccine at approximately 11:50 AM in the right deltoid. At approximately 12:30 PM she complained of itchiness at the site of the injection. An area approximately 2" by 4" was warm to touch, slightly red and slightly swollen an ice pack was applies. She was kept under observation and the symptoms subsided in approximately 20 minutes. There were no other signs or symptoms of distress. Y 11/16/2001 11/16/2001 0 NONE OTH OTH NONE NONE NONE 1
0178889 12/11/2001 PA 77.0 77 F 11/30/2001 Swelling, edema, erythema at site 20 by 10cm. Y Y 11/27/2001 11/28/2001 1 NONE PVT UNK 1
0178890 12/11/2001 MI 1.2 1 .2 F 11/27/2001 Small, red lump on LT starting within 24 hrs of DTaP and has gotten larger. Child having difficulty walking on leg; cries when it is touched. Parent referred to free clinic for evaluation. U 11/19/2001 11/19/2001 0 PUB UNK NONE NONE NONE MI2001093 1
0178891 12/11/2001 MI 72.0 72 F 11/12/2001 24 hrs after vaccination pt felt light headed, weak in her arms and legs, also dizzy. Symptoms lasted 4 days and resolved without treatment. dizziness kept her from normal activities. Y 11/02/2001 11/03/2001 1 NONE PUB PUB NONE some stomach problems only MI2001092 1
0178892 12/11/2001 FL 1.6 1 .5 M 11/30/2001 8:20 Am Projectile vomited, then 10 minutes later had a 5 minute long seizure (fell unconscious, eyes rolled back, seized). This happened 71 hours after vaccination. His temperature was normal 2 minutes after seizure. Y Y 10/22/2001 10/25/2001 3 Cat Scan, EEG and blood work-wnl PVT PVT Sudafed NONE NONE 1
0178893 12/11/2001 GA 1.25 1 .3 M 12/05/2001 Right leg swollen, red and no weight bearing; mildly tender to touch. Motrin and Benadryl Q 6 hours. DTaP given in right thigh. Y 12/03/2001 12/05/2001 2 PVT PVT NONE UNK 1
0178877 12/12/2001 OR 79.0 79 F 11/26/2001 Examined on 11/23/2001 at 3 PM. Red, slightly swollen, warm to touch area 5" by 7.5' on lateral interior aspect right forearm. Pt states swelling had decreased in last 24 hours. Y 11/21/2001 PVT PVT Cough 1
0178883 12/12/2001 MS 4.0 4 F 11/16/2001 The mother stated that the child's left thigh started swelling and turning red on 11/15/01 at 10:00. The child complained of leg being tight and itching. Told mother to give the child Benadryl and apply cold compresses. IF the problem persists or worsens, advised pt to go to PMD or ER. U 11/14/2001 11/15/2001 1 PUB PUB NONE MS01054 1
0178896 12/12/2001 0.2 M 04/30/2002 Information has been received concerning a 2 month old male who on 26-APR-2001 was vaccinated with HIB vaccine. On 01-MAY-2001, the pt experienced hypotonia, laryngeal edema, vomiting, retching, lethargy and drowsiness and was hospitalized. This was originally reported by a RN. No further information available. This report was received from manufacturer and was assigned manufacturer report number HQ6048117SEP2001. Follow up info has been received indicating that on 4/26/01, the pt vaccinated concomitantly with Infanrix, Engerix B, and IPOL as well as haemophilus B conjugate vaccine. No lot number info was provided. The pt was released from the hospital the afternoon following administration. The pt's mother subsequently reported the pt was "back to normal." This was originally reported by a registered nurse. No further info is available. Further follow up info received indicated that the pt was released from the hospital the afternoon following admission not following administration as previously reported. This was originally reported by a registered nurse. No further info is available. Y Y Y 04/26/2001 05/01/2001 5 OTH OTH UNK UNK WAES01114439 1
0178904 12/12/2001 FL 1.25 1 .3 M 12/04/2001 The pt lost speech and social skills (eye contact) and began exhibiting strange behaviors, shortly after his MMR vaccine in 2/99. Y N 02/16/1999 03/10/1999 22 NONE PVT PVT MRI; EEG; Genetics Testing; Blood; Stool; Urine NONE 1
0178905 12/12/2001 NY 76.0 76 M 12/05/2001 Swelling, heat, slight erythema followed by syncope. Treatment with cold compress, resolved in less than 2 weeks. Y 1 Y 11/19/2001 11/20/2001 1 PVT PVT Zocor, Miaspan, Aetoprolol and Flovent CAD, COPD 1
0178906 12/12/2001 OR 36.0 36 F 12/05/2001 Pt phoned emp hlth the last wk of 11/28/01 to report hx of possible adverse reaction post receiving vaccine 10/27/01 - states 20 min post injection had local reaction @ site within 2 hrs had back pain, spine at tailbone pain. Also notes funny taste in mouth. 11/9/01 had SOB & nausea. Tx in ER 11/14/01 for N&V. Admitted to hospital with tachycardia x 2 days 11/17/01, discharged home - has not worked since 11/12/01. Y Y 2 U 10/29/2001 10/29/2001 0 PVT UNK Synthyroid, Pepcid,Valium, Soma, Indocin, Imitrex UNK GERDs, Migraine & tension headache, Hx of backpain, etiology unknown, Hx of arthralgia 1
0178907 12/12/2001 TX 12.0 12 M 11/16/2001 Within 5 minutes of receiving vaccine, pt developed nausea, vomiting, flushing, lightheadedness and diaphoretic. Lungs clear, face pale and diaphoretic. Given 0.3cc epi (1:1000) with good response. Observed for one hour without further reaction. Y Y Y 11/15/2001 11/15/2001 0 VS:115/53 P 48 RR20 T 987.RA PVT MIL NONE NONE NONE 1
0178908 12/12/2001 AZ 78.0 78 M 12/04/2001 Pt presented with a week's history of progressive weakness from the legs ascending up into the upper arms and chest prior to admission. Pt rec'd influenza vaccination about 10 days prior to the onset of symptoms. 2 days prior to his admission, he was not able to get out of bed secondary to the weakness .Lumbar puncture was performed and this was unremarkable, as was MRI of the brain. It was felt that the pt likely had Guillain-Barr syndrome and was started on plasmapheresis. Y Y 25 Y 10/02/2001 10/08/2001 6 Multiple labs performed PVT UNK Coreg, Pyridoxine, Sodium bicarbonate, tums, Magnesium oxide, Glipizide, Albuterol nebulizer treatments, multivitamin. cardiomyopathy, diabetes mellitus type 2, chronic insufficiency, paraesthesias in feet 1
0178909 12/12/2001 AZ 79.0 79 M 12/04/2001 Rheumatology Consultation: Pt developed new onset lower extremity muscle weakness and knee pain. Gait was quite wobbly. Pt states this has been progressive over the past week and was admitted two days ago when he presented to the ER for further evaluation. Pt reports knee pains at night which have been quite painful and he describes this as aching but is not particularly bothered during the day. Pt reports some constipation over the past week.Marked weakness of the quadriceps and biceps femoris muscles bilaterally. Other possibilities include Amiodarone - induced neuromyopathy. Renal consultation: over the course of this hospitalization his symptoms have worsened and full evaluation is consistent with Guillain-Barre. I am being consulted for initiation of plasmapheresis. Pt developed the onset of some orthostasis and weakness, symptoms have progressed to marked proximal and distal lower extremity weakness. Pt has noted some paresthesia of his hands ad increasing weakness of his lower extremities. He finds it extremely difficult at this time to get out of bed. It is agreed the pt should be initiated on plasmapheresis. We will arrange to get a subclavian or IJ line placed for plasmapheresis and will use one plasma volume exchange replacing with albumin. Currently he has no evidence for marked pulmonary involvement. We will follow his FVC's. Per 1 year follow up: Pt has recovered. Y Y U 11/08/2001 11/22/2001 14 white count 8400, hemoglobin 12.5, platelet count 295,000. glucose 112,TSH 1.36, CPK less than 20, pro time 2.11, PTT 71.8, sedimentation rate 92. MRI of the head showed small vessel ischemic changes along with ethmoid and maxillary sinusitis. X-ray of the knees were read as showing moderate degenerative findings. Chest x-ray showed no acute changes. CT scan of the head showed no acute changes. MRI of the lumbar spine is pending. 12/2/01 INR 1.43, pro-time 17.7, CSF protein 112, gram stain negative. glucose 65, cell count unremarkable. 11/29/01 WBC count 8.4, hematocrit 36.6, BUN and creatinine are 16 and 0.9, respectively. Potassium 4.7, urinalysis was negative dipstick on admission. OTH OTH Amiodarone, diltiazem and Coumadin, Asacol, Flomax, tylenol, Vicodin Organic heart disease with a history of mitral valve prolapse for 8 to 10 years; new onset a couple of weeks ago with atrial fibrillation; non-Hodgkin's lymphoma 2 years ago; benign prostatic hypertrophy treated for the past 5 to 10 years; irritable bowel for 5 years; bilateral inguinal herniorrhaphies 35 years ago; eczema on the feet for many years; benign prostatic hypertrophy 1
0178910 12/12/2001 FL 65.0 64 F 12/04/2001 Redness, swelling at least 70mm. U 11/30/2001 11/30/2001 0 N/A UNK UNK Albuteral, Atrovent ,azmacort, vit E, NO elevated BP/Ashtma 1
0178911 12/12/2001 NY 54.0 57 F 11/20/2001 Pt developed pain and difficulty with movement of left shoulder. Pain radiates down shoulder to lower arm. Had decreased range of motion with abduction and rotations. N 11/01/2001 11/03/2001 2 Myopathy. CBC and CPK-wnl PUB OTH NONE 1
0178912 12/12/2001 CA 33.0 33 F 12/15/2001 Red, swollen, warm to touch 45 mm X 35 mm. Y 12/04/2001 12/05/2001 1 PVT PVT NONE NONE 1
0178913 12/12/2001 MD 58.0 58 M 12/07/2001 Cellulitis of R upper arm, bursitis of R elbow, low grade fever. Redness evening of vaccine within 24 hrs of vac. Rx duracef 1gm x 2 days 500mg BID x 8 days 12/12 - feeling much better. Y Y 12/04/2001 12/04/2001 0 NONE PUB UNK NONE NO Hay fever 1
0178914 12/12/2001 UT 38.0 38 F 12/04/2001 1215 flu vac, 1225 complained of swelling arm, SOD, to chest. Benadryl 15 mg. Y U 12/04/2001 12/04/2001 0 OTH OTH Benadryl, Nofpi Lupus only 1
0178915 12/12/2001 IL 6.0 6 F 12/07/2001 Erythema of 5x8cm. Lump, mild warmth and swelling developed in R upper arm at site of flu vaccine. Y 12/04/2001 NONE PVT PVT Albuterol, Flovent Upper respiratory infection H/O raw eggs touched face got hives. 1
0178916 12/12/2001 PA 46.0 46 F 12/06/2001 Pt rec'd flu shot L upper extremities and developed fever to 104F, chills and a severe cellulitis VS allergic reaction requiring admission to hospital. WBC count of 25 15x7cm area of induration and erythema site of injection. Y Y 11/27/2001 11/27/2001 0 WBC 25 PVT OTH Plaquenil, Fos Anax, Buspar, Paxil NONE H/O of Behcet dz, ostopenia, mild COPD 1
0178917 12/12/2001 VA 22.0 22 M 12/05/2001 Left arm muscle myalgia onset date of immunization continues deep arm muscle soreness and point tenderness at injection site. Y U 11/13/2001 11/13/2001 0 UNK UNK NONE NONE NONE 1
0178918 12/12/2001 VA 46.0 46 F 12/05/2001 Persistent pain over injection site with range of motion N 11/07/2001 11/07/2001 0 NONE OTH PUB NONE NONE Penicillin allergy 1
0178919 12/12/2001 CA 48.0 48 F 11/28/2001 11/28@ 1:35came in for swollen painful L arm after flu shot. Used ice packs and advil. 12/3/01 pt called doing fine now, better no redness Y 11/17/2001 11/28/2001 11 NONE OTH OTH NONE allergies, asthma, migraines 1
0178920 12/12/2001 CA 46.0 2 .6 M 12/04/2001 Dizziness starting 30 minutes with flu vaccine until on 2 hours later. Patient returned to Clinic and rested under observation. Y Y 12/03/2001 12/03/2001 0 OTH PVT Tripecol, Beconase NONE Grand mal seizure, Dec 1993. Brain surgery Dec 1993 1
0178921 12/12/2001 KS 61.0 54 F 12/04/2001 Left arm became sore on day of injection in the evening day 2 arm became warm to touch, red with some welts from shoulder to elbow. Instructed to ice area and take Benadryl 25mg every 6 hrs and report to Dr, Friday. Friday called redness was gone welts were gone had some soreness left. will continue benadryl over weekend and call Monday. All symptoms resolved by Monday. Y 11/27/2001 11/27/2001 0 NONE PVT OTH s/p lung cancer hyperlipidema 1
0178922 12/12/2001 KY 83.0 84 F 12/03/2001 Hives developed about 18 hours after injection and treated with Benadryl. Y Y 11/26/2001 11/27/2001 1 PVT PVT NONE Sulfa allergy, osteoarthritis, atrial fib, hypercholesterolemia, stasis dermatitis 1
0178923 12/12/2001 IA 51.0 51 F 12/05/2001 Received flu vaccine 12/03/2001. Woke 12/04/2001 with numbness left side of chest, by noon this has spread into left shoulder, arm, neck and face. N 12/03/2001 12/04/2001 1 NONE OTH PVT Zocor, Prilosec and Celexa NONE Allergic-PCN, Actifed, MVP, hyperlipidemia, restless leg syndrome and GERD 1
0178924 12/12/2001 IL 58.0 58 F 12/06/2001 Left deltoid (site of injection0 red, inflamed, tender to touch. treated with erythromycin 333 TID for 5 days. Y U 12/03/2001 12/03/2001 0 NONE PVT PVT Toprol XL, Estrates, Levsin Aciphex NONE 1
0178925 12/12/2001 AK 26.0 26 M 11/17/2001 The pt states that he had "body aches" about 1 month ago and was getting better, then he got the flu shot and it all came back with body aches and fatigue. He has not seen an MD. U 11/13/2001 11/14/2001 1 PUB PUB NONE Body aches 1
0178926 12/12/2001 TN 1.0 1 .0 F 12/04/2001 Post vax, the pt developed fever and a diffuse, discreet, papular rash on abdomen and trunk. Fever to 104F. Y Y 11/27/2001 11/28/2001 1 PVT PVT NONE NONE 1
0178927 12/12/2001 OH 65.0 65 F 12/04/2001 Post vax, the pt developed chest pain, leg pain, dizziness, nausea and vomiting and a loss of appetite. Her temperature was 101F. Y Y 11/30/2001 11/30/2001 0 Temperature-101F PVT PVT Synthroid 0.125mg qd NONE Hypothyroidism 1
0178928 12/12/2001 MO 38.0 38 F 11/30/2001 Within 8 hours, post vax, the pt developed an abdominal rash, smooth skin but red spots, small and scattered. U 11/27/2001 11/27/2001 0 OTH OTH 1
0178929 12/12/2001 MO 33.0 33 F 11/30/2001 Local reaction in 24 hours: redness, swelling, hot, itchy. Y 11/27/2001 11/28/2001 1 OTH OTH NONE Sulfa 1
0178930 12/12/2001 NY 0.3 0 .3 M 12/05/2001 The pt developed a sudden onset of inconsolable screaming, lasting about 6 hours, post vax. This has persisted about 16-18 hours. He has been given Tylenol every 4 hours. He is otherwise normal today (12/5/01). U 12/04/2001 12/04/2001 0 NONE PVT PVT NONE NONE NONE 1
0178931 12/12/2001 MA 0.2 0 .2 F 12/06/2001 Immediately after injection of PCV-7 vaccine, leg became bright red and indurated. redness spread to lower abdomen and other leg within 1 minute. Benadryl given orally. Flush subsided within 10 minutes. Y 12/06/2001 12/06/2001 0 PVT PUB NONE NONE NONE 1
0178932 12/12/2001 WV 1.5 1 .6 F 11/30/2001 Injection sites of both left and right leg was red, swollen and warm to the touch. The pt's mother reported that it began 1 day after injection. Y Y 11/26/2001 11/27/2001 1 NONE PVT PVT NONE NONE NONE Local reaction~DTaP (Infanrix)~3~0.50~In Patient 1
0178933 12/12/2001 CA 0.2 0 .2 F 12/04/2001 12/01/2001 1 AM low grade fever, 20 minute episode of lip smacking, eyes rolling up, slight stiffness of extremities, unresponsive to environmental stimuli. Seen in ER diagnosed with seizure. Y Y 11/30/2001 12/01/2001 1 EKG-wnl; Spinal tap, urine, blood cultures-all wnl. PVT PVT NONE NONE 36 week gestation premature twin 1
0178934 12/12/2001 OR 4.0 4 M 12/06/2001 Post vax, the pt developed an area of erythema and tenderness (about 6cm X 9cm) surrounding the injection site of right deltoid. U 12/03/2001 12/04/2001 1 PVT PVT NONE NONE Irritable Bowel Syndrome 1
0178935 12/12/2001 TX 0.3 0 .4 F 12/05/2001 Mom states that child "broke out" with a rash (small, red bumps over entire body). She took the infant to ER and was told it was due to immunizations. She was cautioned by the ER physician to have no further immunizations. She was told she might need to skin tests. No medicines in ER. Mom was instructed by ER physician to use Caladryl lotion. Y Y 12/03/2001 12/04/2001 1 NONE PUB PUB NONE NONE Dx'd with bronchitis or pneumonia in September-resolved TX01178 1
0178936 12/12/2001 IL 9.0 10 F 12/03/2001 Post vax, on Saturday, the injection site was itching. On Monday it was the size of 1/2 dollar, hard and red. On Wednesday, she had a rash. No fever. Y 10/25/2001 10/27/2001 2 OTH PVT 1
0178937 12/12/2001 IN 46.0 46 F 10/04/2001 The pt received the vaccine at 14:00 and at 14:30 she complained of feeling flushed and heart rate was increased. She denied any respiratory problems. She stated that she returned to unit and started to feel funny. Her BP was 132/80, HR-112, lungs were clear. No rash was noted. Some redness noted on upper chest wall. Returned at 14:45. Noticed redness on arms but no respiratory problems. She does have hot flashes. Y 10/01/2001 10/01/2001 0 PVT PVT NONE Allergy to Penicillin 1
0178938 12/12/2001 OH 35.0 35 F 11/30/2001 Infection at injection site, swelling on arm at site, spread down arm. Had temp for several days (had antibiotics Cipro). Y Y 11/10/2001 11/11/2001 1 PUB PVT Flu symptoms week before injection 1
0178939 12/12/2001 IL 2.0 2 .4 M 12/06/2001 Post vax, the pt developed body tremors. Y Y 12/04/2001 12/05/2001 1 PVT PUB NONE 1
0178940 12/12/2001 CA 33.0 33 M 12/08/2001 Fever, examthema 10 days after MMR. Y 11/23/2001 12/03/2001 10 PVT PVT NONE NONE 1
0178941 12/12/2001 NY 46.0 46 F 12/05/2001 Pt developed swelling, heat and erythema of arm. Treated with cold compresses and it resolved in 2 weeks. Y 11/06/2001 11/07/2001 1 PVT PVT NONE NONE NONE 1
0178942 12/12/2001 NY 59.0 59 F 12/08/2001 Swelling, erythema right arm. Treated with cold compresses, resolved less than 2 weeks. Y 11/13/2001 11/14/2001 1 PVT PVT Verapamil, glucophase and liptor NONE DM-2, dyslipidemia 1
0178943 12/12/2001 NY 78.0 78 F 11/05/2001 The pt developed swelling, slight erythema and heat; treated with cold compresses and elevation. Y 10/22/2001 10/23/2001 1 PVT PVT Prinivil; Lipitor Cervical strain HTN; Dyslipidemia 1
0178944 12/12/2001 OH 5.0 5 F 12/06/2001 Local reaction at site of DTaP. Redness and swelling size of grapefruit. Y Y 12/04/2001 12/04/2001 0 PVT PVT NONE NONE NONE 1
0178945 12/12/2001 KS 35.0 35 M 12/01/2001 Five to ten minutes after Typhoid shot in left arm got numb, burning sensation and numbness went down to outer two fingers. Left eye and sinuses felt dried out with pressure. Left side of neck and upper back felt tight and painful. Left hip down to ankle had pain. Y 11/03/2001 11/03/2001 0 MIL MIL Zyrtec 1
0178946 12/12/2001 CA 7.0 1 .6 F 11/30/2001 The pt developed a skin rash on 11/29/01. She was seen in my office with typical skin rash of varicella on face (cheeks and chin), neck, upper chest wall, arms, abdomen, etc. Y Y 11/10/1995 11/30/2001 2212 Varicella PVT MIL NONE 1
0178947 12/12/2001 NJ 1.0 1 .1 M 12/03/2001 8-10 vesicles - on back, arm chest afebrile. Y 07/28/1997 12/02/2001 1588 PVT PVT NONE Allergy asymetic, sulfa 1
0178948 12/12/2001 NY 0.6 0 .2 F 09/28/2001 Pt cried inconsolably for 5 hours starting 45 minutes after vaccine administration. Parents give Tylenol prior to vaccine administration. not known if fever present, diarrhea present after shot also. Y 05/03/2001 05/03/2001 0 NONE PVT OTH Tylenol NONE GERD, slow weight gain with vomiting 1
0178949 12/12/2001 NE 22.0 22 M 12/04/2001 Upper mid-back pain following vaccination. Pt reported back, within 8 hours for evaluation. No rash or difficulty breathing. U 12/04/2001 12/04/2001 0 NONE PVT PVT NONE NONE Hayfever 1
0178950 12/12/2001 OH 5.0 4 M 12/05/2001 Pt developed shingles rash, pain and itching on left axilla to shoulder. Y U 04/14/2000 12/03/2001 598 PVT PVT NONE Temperature of 102F and irritability~DTP (no brand name)~1~0.20~In Patient 1
0178951 12/12/2001 AL 10.0 10 M 12/06/2001 One day post injection arm swollen, red and warm to touch. Treatment: warm and cold compresses, Motrin and Benadryl. Y 12/04/2001 12/05/2001 1 PVT PUB Atuss MS URI and allergic rhinitis 1
0178952 12/12/2001 RI 4.0 4 F 12/06/2001 Developed urticaria arms and legs, few lesions. Appeared as early erythema multiforme. U 11/27/2001 12/05/2001 8 NONE PVT PUB NONE NONE History of Henoch-Schoenlen purpura 1
0178953 12/12/2001 MO 1.08 1 .0 F 12/04/2001 The pt developed shingles (blistered rash) on left upper arm. Same location vaccine administered in. Y 10/16/2001 12/02/2001 47 NONE PVT PVT NONE NONE 1
0178954 12/12/2001 MI 4.0 4 M 12/05/2001 Local erythema from biceps (LVZ) to approximately elbow area. Slight swelling and tenderness. Y 12/03/2001 12/04/2001 1 NONE PVT UNK NONE Allergic reaction to Aroxic 1
0178955 12/12/2001 VA 71.0 71 F 12/05/2001 Twelve hours after vaccine- nausea, vertigo, weakness, severe pain at injection site. Y 12/03/2001 12/03/2001 0 PVT OTH NONE Asthma Osteoarthritis 1
0178956 12/12/2001 MI 7.0 1 .3 F 12/04/2001 Mother called 12/4/01. Child has been exposed to chicken pox at school. Fever for 3 days, then broke out with several pimple like bumps with clear fluid blisters on back, face and arms. Itching. U 06/05/1995 12/04/2001 2374 PVT PVT NONE NONE NONE 1
0178957 12/12/2001 OH 7.0 7 F 12/05/2001 Varivax given 11/23/01 subcutaneous at arm. Seen in office 12/5/01 per local reactive at injection site. Y 11/23/2001 12/04/2001 11 PVT PVT NONE NONE 1
0178958 12/12/2001 GA 1.0 1 .1 M 12/05/2001 Ataxia, mild developed this morning. 4PM has improved gait will follow next 24 hours. Y 11/29/2001 12/05/2001 6 PUB PVT NONE NONE NONE 1
0178959 12/12/2001 PA 33.0 33 U Severe local reaction of 10x 7.5 cm area 2 days after Varicella vaccine. Y 12/04/2001 12/05/2001 1 PVT PVT Demulen, Abuterol MPI NONE IVP dye allergy 1
0178960 12/13/2001 MO 3.0 3 M 11/28/2001 The pt had no problems immediately after injection or prior to being discovered dead in crib at 05:45 on 11/28/01. On the last check of pt at 03:00 on 11/28/01, he was laughing and playing. Death certificate indicates the child died from shaken baby syndrome (suffering from this since 5 weeks old according to the dept of health). Y 11/28/2001 N 11/28/2001 11/28/2001 0 NONE PUB PUB Phenobarbital; Baclofen; Robinul; Extendryl; Zyrtec Syrup; Nasonex Spray; Senocot Children's Syrup; NaFl; Acetaminophen Solution; Atrovent Neb NONE Shaken baby syndrome at 5 weeks of age; Blind; CA; Seizures; 13 weeks premature; Disorder microcephaly; NPO with G-tubes MO2001063 1
0178964 12/13/2001 CO 1.8 1 .8 M 01/02/2002 It was reported that a 22 month old male pt received a Fluzone SV '01-'02 vaccination. Reportedly, 10-12 hours, post vax, the pt became very stiff, unresponsive and turned blue for approx. 15 minutes. The child did not recognize his parents during this time. There was no report of fever. Further information is requested. From follow-up correspondence received on 1/2/02 it was reported: "MD diagnosed this as night tremors, did not feel it was a seizure. Very difficult to put mom's history together. Child checked out fine. Has had no further episodes. At this point MD did not feel it was a reaction to vaccine." Reportedly the pt recovered from this experience. The vaccination date 12/05/01 at 3:30pm was also provided. Y 12/05/2001 12/06/2001 1 NONE PVT OTH NONE NONE U2001012360 1
0178965 12/13/2001 NC 66.0 66 M 12/12/2001 Post vax, the pt developed progressive muscle and joint pain, fever, and partial paralysis in muscles (severe leg and shoulder pain). I believe this is Guillain-Barre Syndrome. No tests have been done yet. They act like GBS doesn't exist. The doctors are no help. Y Y Y 10 Y N 11/13/2001 11/13/2001 0 NONE MIL MIL Potassium Chloride; ranitidine HCL; Warfarin; Allopurinol; Vitamin E; Furosemide; Ecotrin; Garlic soft gel Congestive heart failure; Angina 1
0178966 12/13/2001 CA 4.0 M 12/11/2001 Post vax, the pt developed cellulitis of his left arm at injection site. Y Y Y 12/05/2001 PVT OTH UNK UNK UNK 1
0178967 12/13/2001 ME 53.0 53 M 11/30/2001 The pt received the vaccines in his left deltoid. The site bled slightly. The pt's wife called the next day with a pt complaint of fever, achiness and fatigue. Denied swelling or redness at the site. Later that evening, it became warm to touch. The pt was hospitalized but is recovering. According to the pt's doctor, the pt was found to have underlying strept infection. Cultures performed on vaccinee came back negative in 72 hours. Pt was released from the hospital and is doing fine. Y 2 U 11/27/2001 11/28/2001 1 Blood culture-awaiting PVT OTH Albuterol Inhaler; ranitidine NONE ME0143 1
0178968 12/13/2001 OK 55.0 55 F 12/04/2001 Client felt lightheaded and "palpitations" approximately 10-15 min post injection. States palpitations occurred two more times. She notified her doctor and I gave her Benadryl 50 mg by mouth. Y 12/04/2001 12/04/2001 0 OTH OTH Effexor, Premarin, Timoptic Allergic to sulfa drugs X~Influenza (Seasonal) (Fluzone)~~30.00~In Patient 1
0178969 12/13/2001 VA 41.0 41 F 12/07/2001 Felt tingling of upper lip then lip began to swell. Saw personal physician who ordered Benadryl 50 mg. Y Y 12/04/2001 12/05/2001 1 OTH PVT Humalog 75/25; Estrace NONE Sulfur Allergic; Diabetic 1
0178970 12/13/2001 UT 53.0 53 F 11/16/2001 Nausea, abdominal pain, headache. Y 10/25/2001 10/29/2001 4 UNK UNK 1
0178971 12/13/2001 NJ 65.0 65 F 12/11/2001 Palms of hands started itching 5 minutes, weakness, hot and cold, felt faint, throat closed up, blood pressure dropped. Y Y 12/08/2001 12/09/2001 1 UNK UNK 1
0178972 12/13/2001 TX 25.0 24 M 11/15/2001 Redness of skin; feeling of swelling and pain. Y 10/22/2001 10/23/2001 1 NONE OTH PVT NONE NONE NONE 1
0178973 12/13/2001 TX 49.0 49 F 11/15/2001 Itching and pain at site of injection. Y 10/22/2001 10/22/2001 0 UNK PVT 1
0178974 12/13/2001 TX 38.0 38 F 11/01/2001 Red and irritated size of a quarter, Like a mosquito bite. Y 10/22/2001 10/23/2001 1 OTH PVT 1
0178975 12/13/2001 TX 29.0 29 F 11/15/2001 Slight redness Y 10/22/2001 10/23/2001 1 OTH PVT NONE NONE 1
0178976 12/13/2001 TX 21.0 21 F 11/01/2001 Red and irritated. Bump about the size of a quarter. N 10/22/2001 10/23/2001 1 OTH PVT Penicillin 1
0178977 12/13/2001 TX 32.0 32 F 11/05/2001 Ecchymosis approximately 1 cm 24 degree, No therapy. Y 10/22/2001 10/23/2001 1 OTH PVT CIPRO 1
0178978 12/13/2001 TX 33.0 33 F 11/15/2001 Red, itching, heat. Y 10/22/2001 10/22/2001 0 OTH PVT 1
0178979 12/13/2001 TX 53.0 53 F 11/15/2001 Red, itching, heat. Y 10/22/2001 10/23/2001 1 OTH PVT 1
0178980 12/13/2001 TX 29.0 29 F 10/31/2001 Red circle, itching, hot around area where shots was injected. Y 10/22/2001 10/23/2001 1 OTH PVT 1
0178981 12/13/2001 TX 22.0 22 M 11/01/2001 Itching, warm, comp. Red large ecchymotic area, pain. Y 10/22/2001 10/23/2001 1 OTH UNK 1
0178982 12/13/2001 TX 29.0 29 F 10/31/2001 Red/large welt, about the size of a baseball, was hot to touch with itching/discomfort. Y 10/22/2001 10/22/2001 0 OTH PVT 1
0178983 12/13/2001 TX 51.0 51 F 10/31/2001 Red rash, Hehing, hurting (arm when I use it), lump. Y 10/22/2001 10/22/2001 0 UNK UNK Allegra D Sinus 1
0178984 12/13/2001 TX 49.0 49 F 10/31/2001 Dime size bright pink area at injection site time 2 days. Y 10/22/2001 10/23/2001 1 UNK UNK 1
0178985 12/13/2001 TX 63.0 F 10/31/2001 Red, hot, small PUNP and itching. UNK UNK 1
0178986 12/13/2001 TX 23.0 F 10/31/2001 Swollen redish knot with itchiness and soreness. Y UNK UNK 1
0178987 12/13/2001 TX 22.0 22 F 10/31/2001 Right arm (near tricep) swelling, a big lump and redness occurred with itching. Y 10/22/2001 OTH OTH 1
0178988 12/13/2001 NY 63.0 63 M 12/03/2001 About 4-5 hours after vaccine given broke out in hives-upper inner thighs, through the night hives progressively, worsened. Went to ER 7 PM. Given Benadryl IM and predinsone PO. Prescription for Medrol pack. Discharged to home. Initially hives improved. Around noon hives increased. Called PMD , told to take more Medrol. By next AM hives gone. Started to reappear. Called PMD, went to see him and given prescription antihistamine. After several hours improved. By next day completely gone and have not recurred. Y Y 11/27/2001 11/27/2001 0 NONE UNK UNK BP medication NONE Hypertension. No known allergies-poss bee sting. 1
0178989 12/13/2001 FL 43.0 43 F 12/07/2001 Immediate edema and erythema approximately 2 inches in diameter. Pain and erythema at injection site 12/07/2001. No treatment. Y 12/05/2001 12/05/2001 0 NONE PUB PUB Aciphex 20mg NONE History of Multiple Allergies 1
0178990 12/13/2001 OK 50.0 50 M 12/04/2001 Vaccination given in left deltoid 11/23/2001 with immediate swelling approximately 1 inch at 10 minutes. Swelling approx size of quarter. Returned to health unit 12/03/3001 with 2 inch bruise. Y 11/23/2001 11/23/2001 0 PUB UNK NONE Leukemia 1
0178991 12/13/2001 CA 36.0 36 F 12/05/2001 Left arm became acutely red and swollen from site and down to the fingers. Associated with malaise and fever up to 104. Pt took ibuprofen and symptoms decreased 50% by 24 hours and resolved by 72 hours. Y 11/29/2001 11/30/2001 1 PVT PVT NONE NONE Recurrent pneumonia 1
0178992 12/13/2001 ME 43.0 43 F 12/04/2001 Immediately after the injection, pt complained of pain down entire length of left arm. When checked one hour later pain had subsided after being iced but pt still reported painful. Y 12/04/2001 12/04/2001 0 OTH PUB UNK NONE NONE ME01042 1
0178993 12/13/2001 MA 44.0 44 F 11/18/2001 Approximately 16 minutes after flu injection client complained of itchiness all over body and upper body including face was very flushed. Epinephrine 1:1000 0.35cc injected into flu injection site approximately 18 minutes after original flu shot. 911 called at the same time, 4-5 minutes after 1st epinephrine injection. Complained of numb, tingling feeling about face, neck and hands. Second Epi 1:1000 0.15cc injected into the same area. BP 158/84 P 60 Transported to Emergency Room via ambulance approximately 25 minutes after flu vaccine given. Y Y 11/06/2001 11/06/2001 0 PVT PVT NONE NONE Latex Sensitive 1
0178994 12/13/2001 ME 41.0 41 F 12/04/2001 Immediately after receiving vaccine the pt complained about a burning sensation down the entire length of her left arm. Checked with pt 2-3 hrs later and burning had ceased. Y 12/04/2001 12/04/2001 0 OTH PUB UNK NONE Non-specific allergies ME0144 1
0178995 12/13/2001 ME 51.0 51 F Day after immunization, the school nurse where the pt is an employee caller to report had rash from breast to anale with raised quarter size red spots to joint pain by lateral more intense on right than left. Took Benadryl and ibuprofen. Y 11/28/2001 11/29/2001 1 PUB PUB Prempro NONE NONE 1
0178996 12/13/2001 PA 51.0 51 F 11/28/2001 Shot given 11/26/2001. Cellulitis developed 11/28/2001. Y U 11/26/2001 11/28/2001 2 PVT PUB NONE NONE Obesity, ETOH abuse, CUI, CLBP PA0161 1
0178997 12/13/2001 GA 0.2 0 .2 M 12/05/2001 Two to three mm pustalr lesions, slight erythema, on both thighs appearing one day after shots. No hard nodules present. No swelling. Lesions appeared clustered at injection site and then progressively worsened. U 12/03/2001 12/04/2001 1 PVT PVT Amoxicillin Right Otitis Media 1
0178998 12/13/2001 IN 0.7 0 .6 M 12/07/2001 Fever 103.2, extreme fussiness and inconsolable crying for 48 hours. Y 11/04/2001 11/04/2001 0 PUB PUB NONE NONE NONE IN200128 1
0178999 12/13/2001 PA 1.0 0 .9 M 11/02/2001 On the day following Prevnar dose 3, mother states he developed "a rash under the skin all over" and a fever of 102. Both lasted for 4 days. No erythema or swelling noted at injection site. Did not seek medical attention. Called MD's office, said rash may have been due to his "high" fevers. Y 07/25/2001 07/26/2001 1 PUB PUB NONE PA0162 1
0179000 12/13/2001 VA 58.0 58 F 12/07/2001 Pt was scratched by her cat in the eye (right). MD advised TD. Given and reaction occured 12/06/2001. Left deltoid area with redness, slightly swollen. U 11/29/2001 12/06/2001 7 NONE PUB PUB NONE Hypertension 1
0179001 12/13/2001 MA 69.0 69 M 11/27/2001 Pt called BOH following day of vaccine administration. States left arm swollen and red, asked to come to BOH to check area. Pt left arm large amount of redness, swelling from shoulder to elbow, tennis ball size are hot, hard and swollen at elbow area (bracheal artery). Instructed to see MD today. Pt seen by MD 1 hour RID. MD states severe allergic reaction, on Prednisone taper for 7 days. Y Y 11/19/2001 11/19/2001 0 PUB PUB NONE NONE NONE MA0104 1
0179002 12/13/2001 ME 1.0 1 .0 F 12/05/2001 Immediate redness and tender area measured 0.72 by 5.3 ml right arm after MMR immunization. Y 12/05/2001 12/05/2001 0 PVT PUB UNK Runny nose Positive for RSV, prior ear infections ME0145 1
0179003 12/13/2001 OH 57.0 57 F 12/10/2001 Approximately 2 hrs after received vaccine injection site left deltoid reddened with raised firm lump approximately 6 inches in diameter, itching and hot to touch. Ice applied off and on for 4 days. States area looks bruised with soreness on 6th day. Y 12/04/2001 12/04/2001 0 PUB PUB NONE NONE Cirrhosis and diabetes 1
0179006 12/14/2001 MN 37.0 37 F 03/14/2001 It was reported that on 12/2/00, the pt complained of "redness, swelling, hard and raised area, the size of a golf ball with darker red appearance". It was also reported that on 12/3/00, the pt complained of "itching (wearing a wood sweater)". From additional correspondence received on 3/12/01, it was reported that the pt recovered from this experience. Additional lab data, vaccine and responsible facility information were also provided. The pt was given an antibiotic prescription (Keflex) X 1 week. From follow up received on 3/12/01, it was reported that the pt recovered from this experience. Additional lab date, vaccine and responsible facility info were also provided. Y 11/30/2000 12/02/2000 2 PVT PVT NONE Pt is a diabetic. U2001002380 1
0179029 12/14/2001 NV 0.4 0 .1 F 12/10/2001 The pt received immunization at 09:00 and returned to office the same day in the afternoon reporting breathing difficulties, crying since 09:00 and pale. No apnea seen or reported. Y 1 Y 07/31/2001 07/31/2001 0 PVT PUB NONE URI NONE 1
0179030 12/14/2001 PA 52 F 12/11/2001 Client does have an allergy to antibiotics so she took some Benadryl prior to getting the flu shot and denied a reaction to it before. Post vax, she became flushed but had no signs of swelling or shortness of breath. I called the pt back at 12:00 on this date and she stated her tongue swelled and that she took some more Benadryl after I left. At 13:45 on 10/31/01, telephone call to MD's office made aware of above. On 11/6/01, the pt had chills and was thought she might have URI, so a sterile catheter was done for UA. Y Y 10/31/2001 10/31/2001 0 OTH PVT 1
0179031 12/14/2001 F 12/12/2001 Hospital employee given influenza vaccine, then went home. Injection site became red, hot, raised (about 3 by 4 inches). Reported to infection control nurse on 12/12/2001. Still red and hot. 12/10/2001 12/10/2001 0 UNK UNK 1
0179032 12/14/2001 CO 79.0 79 F 12/07/2001 Pt received pneumonia vaccine in right deltoid and flu vaccine in left deltoid on 11/06/2001. On 11/07/2001, pt experienced red, swollen arm. On 11/08/2001 pt went to MD and was given "5 pills". Y 11/06/2001 11/07/2001 1 UNK UNK 1
0179033 12/14/2001 20.0 F Young African American female given flu shot and within 2 hours developed mild left posterior swelling of tongue and inflammation to left bicep. Shot administered at 1300 and reaction noted by 1500 on 12/01/2001. 12/01/2001 12/01/2001 0 UNK UNK 1
0179034 12/14/2001 41.0 41 F 12/07/2001 Pt received Pneumovax left deltoid, IM on 11/08/2001. 4.5 to 5 hours later after injection pt experienced swelling, erythema and numbness in left arm with pain. Approximately 12 hours after injection, pt experienced an asthma attack. Pt used her "inhaler" and symptoms improved. Y Y 11/08/2001 11/08/2001 0 UNK UNK Asthma and antibiotic allergies. 1
0179035 12/14/2001 65.0 65 U 12/07/2001 Redness, swelling, pain at site. Pt feverish starting about 4 hours after shot. Symptoms lasted about 12 hours and were slighty improved after taking Tylenol. 11/08/2001 11/08/2001 0 UNK UNK 1
0179036 12/14/2001 VT 0.8 F 12/10/2001 Strep pneumo bacteremia, later otitis media. Treatment 90 mg/Kg/D Amoxicillin for 10 days. Y PVT PVT NONE Macrocephaly, mild gross motor delay 1
0179037 12/14/2001 MI 41.0 41 F 12/10/2001 Initial pain post-injection followed by vigorous, throbbing pain from lateral aspect of upper humerus to anterior mid-humerus and continuing to posterior aspect of forearm and hand. Visited family physician 1 week post-injection. Am now receiving physical therapy. Arm pain and limited movement left arm. Y N 11/06/2001 11/08/2001 2 Left shoulder X-ray negative. OTH UNK NONE NONE 1
0179038 12/14/2001 RI 68.0 68 M 12/07/2001 Typical flu symptoms, shaking, hot, temp 100.9. Treatment in hospital. Y Y 12/02/2001 12/02/2001 0 Blood test and X-ray OTH OTH NONE NONE 1
0179039 12/14/2001 IN 56.0 56 F Chest pain and shortness of breath U 10/19/2001 10/20/2001 1 PUB UNK 1
0179040 12/14/2001 ME 31.0 31 F 12/05/2001 Pt presents 2 days following flu vaccine with 1.5 inch diameter red firm region of deltoid left arm. No discomfort. Taking ibuprofen PRN. Instructed on use of heat. U 12/03/2001 12/04/2001 1 NONE PUB OTH NONE NONE NONE 1
0179041 12/14/2001 KS 35.0 35 M Fifteen to 20 minutes after flu shot upper left arm got numb burning sensation and numbness went down to outer two fingers. Left eye and sinuses felt dried out with pressure. Left side of neck and upper back felt tight and painful. Left hip down to ankle had pain. Y 12/01/2001 12/01/2001 0 MIL MIL Claritin D ~Typhoid Vi Polysaccharide (Typhim Vi)~7~35.00~In Patient 1
0179042 12/14/2001 WI 75.0 75 M 11/30/2001 Urticaria upper arms, legs, back and abdomen 2 hours after immunization. Pruritic rash. Treated with Sarna lotion 190 hydrocortisone topical and atarax 25 mg 1/2 tablet PO q 6 hours PRN. Y U 11/27/2001 11/27/2001 0 NONE PVT OTH Simvastin and metaformin NONE Diabetes mellitus and hypercholesteremia 1
0179043 12/14/2001 VA 38.0 38 F 12/04/2001 Five reddened, raised wheals approximately 4 cm in circumference on left deltoid that remained unchanged for 3.5 days. By the 4th day, no raised areas, but skin still reddened. Y 11/28/2001 11/30/2001 2 PUB PUB VA01037 1
0179044 12/14/2001 NC 1.08 1 .1 M 12/05/2001 Eyes and lips swollen and ears red. Y 12/05/2001 12/05/2001 0 PVT PUB Xopenex Resolving Bronchitis VATERS, Colostomy, Scoliosis, Hydrocephalus 1
0179045 12/14/2001 VA 44.0 44 F 12/07/2001 Inflammation and tenderness 12/05/2001 12/06/2001 1 MIL MIL NONE 1
0179046 12/14/2001 PA 74 F 12/11/2001 Chills, temp 105, swollen arm, left arm. Pain in arm, shoulder to elbow. Hot and red 0.5 inch from elbow to upper arm. Biojector used (within boundaries of reactions of adverse response to Pneumovax 23 ?). Y Y 10/22/2001 10/24/2001 2 Sed rate and CBC OTH PVT 1
0179047 12/14/2001 CA 43.0 43 F 11/19/2001 Pt states reaction 24 hours later. Left arm red/purple bruised at injection site. No treatment. Pt came to clinic on 11/19/2001. Reaction increased down arm. N 11/13/2001 11/14/2001 1 Pt sent direct OVMC MWI PUB PUB MVI tasix, Aldaltone, Folate, Inderal, Buspar, Klongpin Cirrhosis ETOH NKDA, ETOH Cirrohsis CA01035 1
0179048 12/14/2001 CA 31.0 31 F 11/30/2001 Itchy, redness at site. One diameter, headache, wheezing, elevated respiration, flu-like symptoms and swollen glands. U 11/29/2001 11/29/2001 0 NONE PUB PUB Albuterol, 2 puffs PRN and Serevent, 2 puffs PRN Asthma CA010132 1
0179049 12/14/2001 VA 5.0 1 .2 M Rash, lesions started 12/09/2001 in evening. Pt started Acyclovar this AM. Sib with varicella 2 weeks ago. U 01/28/1998 12/09/2001 1411 PVT OTH NONE NONE NONE 1
0179050 12/14/2001 OK 3.0 1 .9 M Febrile seizure according to EMS. Y Y 05/12/2000 06/25/2000 44 PVT UNK 1
0179051 12/14/2001 WI 18.0 18 F 12/07/2001 Left deltoid are warm to touch, red and minimal swelling. Reddened area was about 3 inches diameter circle. Treated with Zyrtec for 10 days and Biaxin for 10 days. (reacted to previous Hep B per pt.) U 12/05/2001 12/05/2001 0 PVT PVT NONE Left deltoid swelling~Hep B (no brand name)~2~15.00~In Patient 1
0179052 12/14/2001 NY 55.0 54 M 12/13/2001 Pt began feeling numbness in fingers, hands and feet. Also a slight irritation of the skin, all symptoms began on Sunday 12/09/2001. Pt saw MD and neurologist 12/11/2001. He phoned today 12/13/2001 to report symptoms and states he feels a slight improvement today from 12/09/2001. Y U 11/27/2001 12/09/2001 12 ESR, ANA, Lymetiter, FTA, SPEP, Amnio factor, AAC, FBG, Electrophoresis, Anti-Mag OTH PVT NONE NONE NONE 1
0179053 12/14/2001 TX 75.0 75 F 12/04/2001 Arm redness and swelling. Y 12/03/2001 12/03/2001 0 PVT PVT Zyrtec and Flovent Asthma and seasonal allergies 1
0179054 12/14/2001 MN 34.0 34 F 12/10/2001 Vaccine given in afternoon of 11/26/2001 left arm SQ. On 11/27/2001 the site became red and swollen. On 11/28/2001 pt reported the site continued to hurt and her feet were very sore and had blistered. She had 6 blisters on her right foot and 4 on her left in all. Was seen in ER on 11/28/2001. Y Y 11/26/2001 11/26/2001 0 NONE PUB PVT NONE NONE NONE 1
0179055 12/14/2001 GA 67.0 67 F 12/05/2001 Right upper arm red, warm to touch, painful, edematous approximately 1 day after vaccine administration. Client states taking Advil, advised warm moist heat. Client states redness and pain subsiding. Y 12/03/2001 12/03/2001 0 NONE PUB UNK NONE Codeine 1
0179056 12/14/2001 NC 69.0 69 F 11/29/2001 At site of vacine, left deltoid, had induration, redness, warm to touch, itching, Covered area of upper arm. Saw MD advised cold compresses, Claritin for itching. Y Y 11/28/2001 11/28/2001 0 NONE PUB PVT ASA, Zocor, Glucophage, Zesteretic NONE PCN NC01105 1
0179057 12/14/2001 VA 7.0 7 F 12/04/2001 Some tenderness with 3 papules noted at vaccine site. Examined by physician, diagnosis Varivax reaction. Y 11/02/2001 11/15/2001 13 PVT PVT NONE 1
0179058 12/14/2001 TX 1.4 1 .2 M 11/20/2001 Came in 09/05/2001 spot on leg, cellulitis left leg. Rx Keflex 250 mg BID for 10 days. Vaccines given 08/20/2001, Varivax to left leg. Came in 11/15/2001 left leg with abscess, incision and drainage and culture sent. No growth in culture as of 11/19/2001. Y Y 08/20/2001 09/05/2001 16 Culture sent. No growth in culture as of 11/19/2001. PVT PVT Eczema NONE 1
0179059 12/14/2001 WI 5 F 12/07/2001 Five by seven cm red, indurated, swollen patch at injection site. U 12/04/2001 12/06/2001 2 PVT PVT Constant Cough NONE 1
0179060 12/14/2001 OH 40.0 39 F 12/08/2001 Pt received Hepatitis B 2nd dose on 03/10/2001 0730. He induced a small bump immediately after the injection. The lump has gradually increased in size and pt really noticed the size change in Spetember 2001. Arm is tender and sore to touch. 3 by 3 cm left arm. N 03/10/2001 09/01/2001 175 MIL MIL NONE NONE 1
0179061 12/14/2001 CO 53.0 54 F Shingles - symptoms appeared 12/6/01 Y Y 11/26/2001 12/06/2001 10 NONE PVT OTH NONE NONE 1
0179062 12/14/2001 IL 3.0 3 M 12/03/2001 3am - woke up crying & screaming - had high fever (mom didn't have thermometer) red cheeks, swelling at sights of injections - mom gave ibuprofen & child went back to sleep; woke up again vomiting would jerk - so much that he hit himself in the head but he seemed not to notice - he just stared. He went back to sleep & in the morning he was moving slowly, drooling a lot, bump his head into the wall or curl upon his side on the floor, still staring a lot, wasn't talking. Mom took him to Dr at 3:45pm on 11/30/01. Dr felt child had had some sort of seizure. possibly due to high fever or reaction to shots. Dr told mom that when child comes for DTaP booster - he should not get Pertussis vaccine. Each day child has improved. As of 12/3/01 child is behaving normally except for decreased appetite. Y Y 11/29/2001 11/30/2001 1 NONE PUB PUB Lotrisone cream NONE except ringworm NONE ~Diphtheria Toxoids (no brand name)~2~0.30~In Sibling IL01050 1
0179063 12/14/2001 PA 17 F 12/06/2001 Cellulitis. Treated with Keflex 500 mg T PO TID for 10 days. U 12/05/2001 12/05/2001 0 NONE OTH PVT NONE Type 2 DM 1
0179064 12/14/2001 CA 6.0 6 M 12/02/2001 Swelling right shoulder, forearm and hand rash on trunk and legs. Y Y 11/30/2001 11/30/2001 0 PVT OTH Beconase Allergic rhinitis 1
0179065 12/14/2001 CA 17.0 17 F 12/02/2001 Pt developed a flushed face and dizziness. Y 11/28/2001 11/28/2001 0 PVT OTH Orthotricyclen NONE NONE 1
0179066 12/14/2001 CA 75.0 75 F 11/13/2001 Pt complained of a sore arm. She couldn't lift arm on 11/2/01. On 11/10/01, she had a sore throat with phlegm. She denied fever. On 11/11/01, she went to the doctor and was treated with amoxicillin. She feels better. Y U 11/02/2001 11/02/2001 0 OTH PUB NONE NONE NONE CA010134 1
0179067 12/14/2001 CA 52.0 52 F 12/03/2001 One week, post vax, the pt felt cold chills, allergies and pain in sinuses. She was very weak and it has not gone away. Treatment was for a dog bite. Antibiotics given also. Y N 10/03/2001 10/10/2001 7 NONE PUB PUB NONE NONE Minor sinus problems CA010133 1
0179068 12/14/2001 NC M 12/12/2001 Pt has a knot in left thigh 22mm X 25mm and erythema at injection site. The knot persist. Y N 12/07/2001 12/07/2001 0 PVT PUB NONE NONE 1
0179069 12/14/2001 GA 5.0 5 F 02/12/2001 This is not an adverse event, the pt has parotitis/probable mumps. Mumps reported to the health dept. U 02/17/1999 PVT PVT 1
0179070 12/17/2001 CA 1.75 1 .7 M 12/03/2001 On 12/1/00, my son was given 4 vaccinations. His appointment was at 09:15. The morning of 12/2/00, he was out of sorts. He had a low fever, he didn't have an appetite, he was extremely tired and very cranky. He was not acting in the usual manner at all. I know that vaccinations can sometimes cause these types of symptoms. I gave him the recommended dosages of Children's Motrin throughout the day to lower his fever. It alternated between 100F and 101F. On 12/3/00, he continued to be very cranky but his fever had gone away. He was acting unusually aggressive. He was not his "normal" self, but he did not show extreme signs of illness. My husband and I both commented that we hoped the vaccinations had not caused him some kind of harm. This child was normally extremely easy going and never cranky. In fact, it was the 1st time we had seen him in a "bad" mood. On 12/4/00, he woke up in the morning and as I was getting him dressed, I noticed that he had 1 fluid filled blister on the top of each of his knuckles. (I had been under the impression that he had received his Varicella vaccination per the nurse at my doctor's office). I called the advice nurse and told her about his blisters. She said that they were probably a result of his vaccination. She indicated that they were contagious until they dried up. By 12/6/00, they were completely gone. They did not crust over or anything, they just disappeared. He actually did not receive his Varicella vaccination, so they could not have been chickenpox. Throughout the month of December, he continued to act really tired and would take long naps. I did not know why he was sleeping so much, but he did not exhibit classic symptoms of obvious illness. He also had some unusual behavior that he was crankier than usual. On 1/9/00, we were playing at about 16:00. He began rubbing his eyes. I asked him if he wanted to go "night night" and he responded "yes". I took him into my bedroom and we rested on my bed. He rubbed his eyes and said, "Owie". A few tears rolled out the sides of his eyes as if his eyes were tearing. He rolled over and fell asleep. By this time it was 16:20. His older brother and a friend were playing in the room where he was sleeping. I told them to play outside so they would not wake him. I checked on him several times. At 17:00, I looked in on him and found him face down. I turned him over and he was blue, his eyes were half open and he wasn't breathing. He had blood coming out of his nose. I began CPR. My son called 911. He never regained consciousness. He was pronounced dead at the hospital about 1.5 hours after I found him. This was a perfectly healthy child. An autopsy was done. The cause of death was undetermined. Upon 6 months of further investigation, the Medical Examiner still has no absolute cause of death. The main findings are that his spleen was enlarged and full of white pulp (denoting massive white blood cell production) and his brainstem had a foci of mild inflammation. It has always been my gut feeling that he was harmed by his vaccinations. I have never been opposed to vaccinations. My other child and this child ha both been regularly immunized. I know investigators don't believe in intuition, but I have a very uneasy feeling about this round of immunizations. I can't say why, it is just a feeling that I now trust. I hope you give the death of my child a thorough investigation. I would hate for another child to die or a family to have to go through this gut wrenching hell and grief. The truth is, children are rarely harmed by immunizations. I want to know if my son was that one in a million. It is very hard not to know why your perfect, healthy child suddenly dies in an instant with no explanation. I appreciate your attention and diligence in honoring the need for an extensive investigation. Y 01/09/2001 N 12/01/2000 01/09/2001 39 Autopsy PVT PVT Children's Motrin prior to vaccinations NONE NONE 1
0179075 12/17/2001 NH 34.0 33 F 12/06/2001 Pt developed fatigue, pain in back and limbs (severe), sore muscles, excessive hair loss, loss of appetite, alternating constipation and diarrhea, numbness in her left arm (site of injection) and nausea. Diagnosed with perfuse myalgia. Per 1 year followup: Pt has not recovered. Muscle and joint pain. Fatigue. Diminished motor skills, loss of critical thinking skills. Depression. Intermittent blurred vision. Loss of ability to work. Insomnia. Comments: I wish I never agreed to be vaccinated with the Hep B recombinant vaccine. It has uined my quality of life! Thank you for caring. 01/08/2003 Pt Y Y N 12/07/2000 04/24/2001 138 All X-rays, MRI, CT Scan and blood tests appear normal. PUB OTH NONE NONE NONE 1
0179076 12/17/2001 CT 10.0 10 M 12/10/2001 The pt was seen in the office on 10/25/01 with a mild sore throat and conjunctivitis. He had no fever. Review of immunization status showed that he had not yet received the Hep-B vaccine series. He was given the 1st Hep-B vaccine and a prescription for Erythromycin ophthalmic ointment. The pt again presented to the office on 11/10/01 with a 10-14 day history of polyuria and polydipsia. He was admitted to the hospital on 11/10/01 and dx'd with Type I diabetes. He was discharged from the hospital on 11/12/01 in good condition on SC insulin. Of note, the pt's father has had insulin-dependent diabetes since his own childhood. Y 3 Y N 10/25/2001 10/27/2001 2 Blood glucose-270; glycosuria; ketosuria in the office PVT PUB Erythromycin ophthalmic ointment Conjunctivitis and pharyngitis NONE 1
0179077 12/17/2001 VA 60.0 60 F 11/21/2001 Fever, headache, neck stiffness. Pt hospitalized 11/20/2001. Y Y 11/08/2001 11/13/2001 5 CSF culture, blood culture, CBC, all results pending. PVT PVT Tamiflu, Analgesics NONE sulfur allergy, COPD, diverticulitis VA01038 1
0179078 12/17/2001 ID 0.6 0 .6 F 11/29/2001 On 8/10/01, pt developed a high fever of 104F. Three or four days later, she had a rash (doctor said it looked like Roseola) all over her body. Over about 2 weeks time, after the rash, she gradually became unable to sit up any more, her eyes were crossed and danced around. Her head would drop to the side (right or left) and lay on her shoulder. She quit eating solids. Had a rash and fever recently. The fever lasted 3 days and the rash lasted 2 days. It seems to improve slightly lately. Y N 08/02/2001 08/10/2001 8 The neurologist has done all kinds of test on pt. PUB PUB NONE NONE ID01078 1
0179079 12/17/2001 MI 59.0 59 F 12/03/2001 Pt states 1st day hot hot, hard & itchy and 2nd day hives under L axilla and spread to breast & legs. 3rd day arm very swollen, could not bend, hot to touch and very red. Went to ER 12/1/01. Given Benadryl, Solumedrol, Prednisone packet and cortisone cream. Instructed pt to call her family Dr to make him aware, and not to get flu vaccine in the future. Pt stated she has had flu vaccine for 10 yrs except for last year when there was a shortage. Y Y 11/28/2001 11/28/2001 0 PUB PUB Asthma 1
0179080 12/17/2001 MI 31.0 31 F 12/04/2001 Within 15 minutes complained of numbness entire length of arm. Within 30 minutes, hot and flushed, SOB upon lying down, started to vomit twice. Within 2 hrs, diarrhea onset lasting 48 hours. Taken home. Vomited 3 times. Unable to function. At 40 hrs from onset had severe headache lasting 8 hours. Y 11/24/2001 11/24/2001 0 UNK OTH NONE Psoriasis 1
0179081 12/17/2001 VA 64 F 12/07/2001 Local redness, swelling noted ? some difficulty moving arm. Took tylenol felt better. By 2/6/01 arm @ point of injection very swollen. Saw Dr who placed her on Keflex for 5 days. (6 inch swollen). Y Y 12/04/2001 12/04/2001 0 NKDA PUB PUB Synthroid, estradiol patch NONE Allergic Phenobarbital, phenergan, decadron, Novocain 1
0179082 12/17/2001 MA 58.0 58 F 12/07/2001 Rec'd flu vaccine 12/5/01 4:30pm. Developed fever, chills, headache. 11am 12/6 Tx with tylenol - Sx free as of 9pm 12/6/01. Y 12/05/2001 12/06/2001 1 NONE PVT OTH NONE NONE ~Influenza (Seasonal) (no brand name)~~0.00~In Sibling MA0105 1
0179083 12/17/2001 NY 82.0 82 F 12/06/2001 Intensive itching at injection site, no rash or fever. Pt went for medical follow up. Prescribed benadryl for itching. (red around site) Y 11/30/2001 12/01/2001 1 NONE PUB PVT NONE NO NO 1
0179084 12/17/2001 ID F 12/14/2001 Pt with increased pain, redness and fever following injection, and developed cellulitis L deltoid. Y U 11/20/2001 11/30/2001 10 MIL OTH NONE ASA, Sulfa, PMH: asthma 1
0179085 12/17/2001 NY 46.0 46 F 11/19/2001 10 minutes after receiving vaccine in L deltoid arm, pt felt warm in chest and L arm itching itching of L arm then became ?. Developing a few hives on neck. Benadryl PO given with resolution of most symptoms. Y 11/19/2001 11/19/2001 0 PUB PVT NONE allergist diagnosed latex allergy 1
0179086 12/17/2001 NC 20.0 20 F 12/07/2001 Loss of appetite no energy, breaking out in cold chills, nausea, headache - hurts when I walk and open my eyes. Took some tylenol, it suppressed the headache but it feels like it might coming back. Y 12/06/2001 12/06/2001 0 MIL MIL IPPD/Conn/C0866AB/LFA-2/9/24/01 Allergic to Penicillin 1
0179087 12/17/2001 MI 71.0 71 M 12/10/2001 The pt states he felt immediate pain at the injection site and continued to have pain and then had difficulty with mobility of left shoulder. He presented to MD on 12/6/01 to evaluate. Pt dx'd with a frozen shoulder. No redness or swelling at the site. Pt sent to physical therapy. Y Y 11/14/2001 11/14/2001 0 NONE PVT PVT Imdur; Prinivil; Prinizide; metoprolol; Zocor; glipizide; ASA DM; CAD 1
0179088 12/17/2001 MO 35.0 35 M 12/08/2001 2 days, post vax, the pt developed acute onset of high fevers 102F-103F, headache, mild cough, arthralgias, myalgias, near syncope, diaphoresis and tinnitus. Y U 12/03/2001 12/05/2001 2 Strept Screen; A, Throat-neg OTH OTH NONE NONE NONE 1
0179089 12/17/2001 CO 10.0 9 M 12/11/2001 While visiting with mother about another sibling, the mother mentioned that the pt had became dizzy, weak and pale, 2 hours after receiving the flu vaccine on 11/30/01. No apparent emergency care was needed. Told mother that she should mention this to the doctor the next time she was in the office. Y 11/30/2001 11/30/2001 0 NONE PVT PVT NONE NONE NONE 1
0179090 12/17/2001 LA 10.0 10 M The pt developed hives, 5 days, post vax. He was treated with Prednisone, Claritin and Benadryl. Y Y 11/14/2001 11/18/2001 4 PVT PVT NONE NONE 1
0179091 12/17/2001 ID 70.0 70 F 11/21/2001 On day 1, post vax, the pts arm was sore. On day 2, she had a stiff neck X 1 day. On day 5, she had swelling of the face with hives on face and neck X 1 day. Also on day 5, she had itching of her face X 2 days. Then on day 5, she had night sweats X 1 day. N 11/15/2001 11/17/2001 2 NONE OTH PVT Lasix; Lotensin; Premarin; Micro-K Chronic UTI HTN, Chronic UTI ~Influenza (Seasonal) (no brand name)~~70.00~In Sibling ID01072 1
0179092 12/17/2001 CO 1.25 1 .3 F 05/30/2001 Mother reported that on the following day, child was unable to walk, left leg was swollen and had a slight bruise. No fever. Instead of walking, he refused to stand and cried when leg was touched by mother. Mother reports that pt was seen in ER. Child was walking, running and completely recovered. MD at the hospital informed mother that it was a vaccine reaction. Y Y 05/29/2001 05/30/2001 1 NONE PUB PUB NONE NONE NONE CO01022 1
0179093 12/17/2001 OR 0.5 0 .5 M 11/28/2001 On 11/26/01, in the evening, the child was fussy and crying for over an hour. On 11/27/01 AM, his temperature was 105F and not relieved by alternating APNP and Motrin. At 21:30, the fever was down and left leg was swollen, "fire engine red" and hot to touch and had diarrhea. On 11/28/01, his left leg was still swollen "twice the normal size and child was lethargic and fussy. He had only taken 1 8oz bottle since AM and had only 2 wet diapers today. Mom is taking child to PCP. Y U 11/26/2001 11/27/2001 1 PUB PUB NONE Teething/runny nose NONE OR200146 1
0179094 12/17/2001 ID 1.0 1 .1 M 11/19/2001 Pt developed a fever, was fussy, had redness and swelling of the right upper leg. Y 11/16/2001 11/16/2001 0 PVT PUB Allergy to Augmentin ID01070 1
0179095 12/17/2001 ID 0.2 0 .2 M 07/27/2001 20 minutes after injection, the child began coughing, crying and wouldn't eat or drink. Took him to see the doctor with a temperature of 103F. Now he is "barking like a seal". Y U 07/26/2001 07/26/2001 0 PUB PUB Had a cold. ID01069 1
0179096 12/17/2001 ID 1.2 1 .2 M 11/26/2001 The pt started running a fever between 101F-104F from 11/21/01 to 11/25/01 and had 1 vesicle above his left knee. Y 10/31/2001 11/21/2001 21 CBC OTH OTH ID01074 1
0179097 12/17/2001 ID 0.7 0 .7 M 12/05/2001 The pt developed a fever of 105F. Y Y 12/04/2001 PVT PUB NONE Possible milk allergy ID01080 1
0179098 12/17/2001 MO 40.0 40 M 12/04/2001 Pt states arm (L) was sore 24 hrs after vaccine latissimus, bicep and pectoral but not deltoid. Also L armpit area N 12/03/2001 12/04/2001 1 PUB PVT NONE MO2001062 1
0179099 12/17/2001 NH 6.0 1 .0 F 12/04/2001 Pt developed red papules various sites on body 12/2/01. Y 04/18/1996 12/02/2001 2054 PVT PUB 1
0179100 12/17/2001 OK 49.0 49 F 12/07/2001 6 month diabetic follow up routine vaccination protocol. Severe local reaction, painful with exertion, aching at rest L arm. redness and swelling, initially at injection site, by 12 noon from L shoulder to mid forearm. Full circumference of upper arm to elbow. Anti-cubital area to mid forearm. Hot to touch continues x 30 hrs. Tx w/ antihistamines, anti-inflammatory, ice. Y 12/06/2001 12/06/2001 0 NONE PUB PUB entex, Flonase nasal inhaler, fosinopril, simvastatin, Zoloft NONE Diabetes type 2, hypertension, hyperlipidema, allergy erythromycin 1
0179101 12/17/2001 PA 7.0 3 F 12/10/2001 Mother stated 10 pox on trunk and dew drop on rose petal; 2 vesicles, crusted lesion 1 pox is pruritic. Afebrile; exposed in school. Y 12/18/1997 12/03/2001 1446 NONE PVT PVT NONE NONE NONE 1
0179102 12/17/2001 NH 7.0 2 .2 F 12/07/2001 Fever, full course chicken pox, over 200 lesions. Y 07/03/1996 12/05/2001 1981 PVT PVT NONE NONE 1
0179103 12/17/2001 IN 1.0 1 .3 F Developed patchy, multibilliform rash, primarily over trunk; about 10 days after MMR. Y 10/25/2001 11/03/2001 9 PVT PVT 1
0179104 12/17/2001 SD 2.5 0 .1 F 12/07/2001 Varivax vaccination given 01/14/2000. Came to clinic 11/29/2001 with chicken pox. Y U 01/14/2000 11/29/2001 685 PVT PUB 1
0179105 12/17/2001 AZ 69.0 69 F 12/08/2001 Right antecubital, periarticular elbow swelling, erythema, warmth, tenderness; arm elevation, cold packs. Y Y 11/28/2001 11/29/2001 1 PVT PVT Anegrelide, Estrace, Synthroid, Fosamx, Calcium NONE Penicillin, Cephalexin; Thrombocytosis 1
0179106 12/17/2001 NY 3.0 1 .0 F 02/20/2001 Two years ago 12/1998 pt received the chicken pox vaccination. The next day he became very lethargic, developed a rash all over his body and developed a fever 103-105. He had convulsions at the doctor's office. Motrin was administered by a nurse. He had no cold nor developed any cold or flu or virus. Pt recently had a febrile seizure which made mother recall the 12/1998 febrile seizure, although this time his diagnosis was an ear infection. Y U 12/08/1998 12/09/1998 1 PVT OTH NONE NONE 1
0179107 12/17/2001 IA 56.0 56 F 12/10/2001 Insomnia that night. Very significant swelling of left upper arm. This spread to the left forearm a couple of days later. Fever on 1st night. Passed out on 11/29/2001 in AM for a few minutes. Y 11/28/2001 11/28/2001 0 PVT PVT 1
0179108 12/17/2001 TX 4.0 4 F 11/30/2001 Left VOQ became red and warm to touch by the AM of 11/29/2001. Area tender, measures approximately 6.5 cm by 3 cm. Instructed to apply warm compresses QID and PRN. Y Y 11/28/2001 11/29/2001 1 PVT PVT NONE NONE 1
0179109 12/17/2001 GA 4.0 4 M 12/13/2001 Swelling at site of injection 24 hrs after IPV given same arm. Arm swollen and itching site IPV. Compresses to arm. Benadryl 12/12/2001. Advil days after immunization. Y Y 12/10/2001 12/11/2001 1 PUB PUB 1
0179110 12/17/2001 CO 79.0 79 F 11/20/2001 Pneumonia vaccine given 11/06/2001. Next day pt experienced red and swollen arm. Two days after shot went to MD given "5 pills". Y Y 11/06/2001 11/09/2001 3 PUB PVT Multiple meds for multiple problems NONE NONE CO01023 1
0179111 12/17/2001 ID 4.0 4 F 11/08/2001 Immunization was given 09/14/2001. PPD negative on 09/17/2001. On 09/18/2001 pt presented with cough, congestion. Dx: URI. Tx: Carbinosane Syrup and Tylenol PRN fever. On 10/02/2001 pt presented with lump left site of neck since 10/01/2001. Complained also of itching. Mom noticed lesion on back of left ear and one near buttocks. Within a few hours broke out in rash over neck, face, trunk and extremities. complained of runny nose. No fever. Diagnosis of varicella infection. Advised Benadryl and Aveeno baths. Y 09/14/2001 10/01/2001 17 NONE UNK UNK PPD right inner forearm Lot C0150AA NONE ID01067 1
0179112 12/17/2001 OR 21.0 21 F 11/28/2001 Pt walked into HD 11/27/2001 with complaint of rash. Upon assessment, found to have reddened oval areas with defined borders to face, neck, chest, abdomen and back. Reddened areas slightly raised with scaling/peeling centers. Treatment: Allegra PO and clicon cream. Pt reported symptoms began 48-72 hours after vaccine administration. No local reaction at injection sites. Y 11/07/2001 11/09/2001 2 PUB PVT UNK UNK UNK OR200145 1
0179113 12/17/2001 FL 27.0 27 F 11/21/2001 Mild macular rash on face neck and torso. Y 11/12/2001 11/14/2001 2 OTH OTH NONE NONE 1
0179114 12/17/2001 NJ 53.0 53 F 12/08/2001 Prolonged constant deep aching pain in upper left arm muscle and shoulder. Weight bearing and use limitation due to pain. Pain worsens when lying down, i.e. sleeping. Pain continues as of this writing. Y N 10/04/2001 10/10/2001 6 PVT OTH Augmentin Dog bite left forearm NONE 1
0179115 12/17/2001 ID 37.0 37 M 11/29/2001 Client given Twinrix immunization. While playing he passed out (approximately 15 minutes after injection). Stated he felt dizzy. Color was very pale, skin cool. BP 100/60 P 60. After lying down for 30-45 minutes he felt fine. Y 11/29/2001 11/29/2001 0 NONE PUB PVT NONE NONE NONE ID01077 1
0179116 12/17/2001 WA 18.0 18 F 10/19/2001 Client developed "knot" to left deltoid. Y 10/17/2001 10/17/2001 0 PUB PUB ID01076 1
0179117 12/17/2001 WA 20.0 20 F 10/19/2001 Client continues to have bleeding from injection site. Bleeding is sporadic. Y 10/17/2001 10/17/2001 0 PUB UNK ID01075 1
0179118 12/17/2001 ID 4.0 4 F 11/23/2001 Mother states child woke up at 10:30 AM left arm swollen, very red, hot and firm across entire arm from shoulder to 2-3 inches above elbow. Called ER was told warm compress and Tylenol. Swelling increased and arm became bluish. Took child to ER. States that ER MD told her this was the worst infection to immunizations he had ever seen. Child given antibiotic (augmentin) and advised to use Motrin for discomfort. Y 11/20/2001 11/22/2001 2 NONE PUB PUB Amoxicillin Head cold symptoms NONE ID01073 1
0179119 12/17/2001 ID 1.0 1 .1 F 11/15/2001 Developed temperature of 104 by 11/14/2001. Red, swollen upper right arm by Urgent Care site was called by parent. Cool compresses to site and Tylenol were recommended. 11/16/2001 Called back to parent (mother) swelling and heat gone. No fever. Recommended next DTaP be given in physicians office. Y 11/13/2001 11/14/2001 1 PUB PUB NONE NONE NONE ID01071 1
0179120 12/17/2001 ID 23.0 23 F 10/29/2001 Fever of 102.1, flu like symptoms, achiness, sensitivity to light, severe headache. Y 10/25/2001 10/26/2001 1 PUB PVT ID01064 1
0179121 12/17/2001 ID 43.0 43 F 10/29/2001 On 09/12/2001 Rash on back, 2100 hrs. Itchy all over today 09/18/2001. Y 09/12/2001 09/12/2001 0 PUB PUB UNK NONE Allergic to codeine ID01065 1
0179122 12/17/2001 ID 40.0 40 F 11/06/2001 On 11/20/2001 Husband states began with rash on the chest, spread to entire body. Wife complained of dizziness, itching and nausea. No medication was taken. Client didn't seek other medical attention. Y 10/30/2001 11/02/2001 3 PUB PUB NONE NONE Sulfa and penicillin ID01066 1
0179123 12/17/2001 TX 58.0 58 F 12/12/2001 1.5 days after injection fever 100-102, 3rd or 4th day post injection, red rash over neck, arms, back and legs. Given steroid shot and cortico steroids by MD on 4th day after injection. Fever did not go away until 8 days after vaccine. Blisters on tongue, gums and oral cavity. Y Y 12/03/2001 12/05/2001 2 PUB PUB HTN meds and oral agents for DM NONE Diabetes Type II and HTN 1
0179124 12/17/2001 ID 0.6 0 .7 F 09/26/2001 On 09/26/2001, Mother in for 12 month immunizations. Client had come to clinic in May 2001 for IPV. Returned approximately one week later stating daughter had developed rash or hives on abdomen one day after receiving vaccine. Discussed possible allergies to foods or soaps. Client sought medical attention when rash did not resolve after changing brands of laundry soap. Mother states rash increased in size and extended to arms and lower extremities. PMD suggested possible reaction topreservative in IPV. Client given Benadryl. Rash subsequently resolved. Y Y 05/25/2001 05/26/2001 1 PUB PUB UNK NONE ID01068 1
0179125 12/17/2001 ID 2.9 2 .9 M 12/05/2001 Call was made by grandmother to HD at 12:50 PM. She states pt was non-responsive. HD nurse instructed to take child to ER. Child was reported to be responsive before arriving. He developed a rash on hands and arms and was instructed by ER MD to have no more vaccinations before age 4. No fever. Child was alert by 5 PM. Rash fading by next AM. Several follow up calls were made. Y Y 11/28/2001 11/28/2001 0 NONE PUB PUB Singulair and Albuterol Asthma ID01079 1
0179126 12/17/2001 DE 24.0 24 F 10/05/2001 At visit on Wed 10/03/2001 client stated she noticed a lump under ram, called on Friday to report on vaccines, called MD he believes she has side effects from med. Started on 09/08/2001 felt dizzy, nauseous, vomited, rapid heart rate, tingling sensation, headache, fever for 30 minutes everyday since then slightly similar feeling second vaccine 09/12/2001 and third 10/03/2001. Called MD and asked to be seen on 10/04/2001 by MD. Y N 09/05/2001 09/08/2001 3 PUB PUB NONE NONE Allergic to bee stings Fever~Vaccine not specified (no brand name)~~0.00~In Patient MD01007 1
0179127 12/18/2001 MO 0.25 0 .2 M 12/13/2001 The parent reports the pt did not have any problems after his shots. He had an upper respiratory infection about 2-3 weeks ago and completed antibiotics about 1 week ago. He was seen in ER. The ER dx'd URI with nasal congestion. He had green matter in both eyes and that was dx'd as conjunctivitis and treated with Polysporin optical ointment. The child was fed a bottle of Enfamil with Iron about 10:00 and was found unresponsive and pronounced DOA at 11:41 at the hospital. The hospital will fax Health Dept report. The baby was found by coroner with a bottle propped in the crib with a pillow and stuffed animals. COD as per autopsy report -- undetermined. Per F/U 4/13/02: Pleural surfaces have focal petechiae and are atelectatic. Lungs show edema and congestion, the liver shows congestion and the kidneys show a focal area of chronic inflammation. Y 12/12/2001 N 11/27/2001 12/12/2001 15 Autopsy results pending PUB PUB Completed antibiotic therapy 1 week ago for upper respiratory infection. NONE Respiratory infection 2-3 weeks ago. 1
0179128 12/18/2001 MO 0.2 0 .2 M 12/14/2001 Pt was fed Enfamil with Iron. At 20:15 the pt was asleep in his crib on his abdomen. He was found unresponsive at about 21:15. DOA at the hospital at about 21:20. Other family members were ill with vomiting for 2-3 days prior to his death. On 12/13/01 at 04:15, a call was received from the child's mother, reporting that her son died last night and wanted to let the health dept know that Family Services will be calling us regarding immunizations given, dates and possible side effects. She expressed concern about Prevnar vaccine and infant's death. She reported that "he just did not act like the same child after he got his shots." I asked her if he ran any fever after he received his shots and she said no. She was giving him Tylenol every 4 hours for 24 hours, post vax. She noticed his "appetite had decreased a little every day since he was immunized and that his muscles seemed tense. He was not really sick and sometimes he would laugh and smile but yesterday, he did not want to eat at all and just wanted to sleep all day." He was seen at ER with a "runny nose" (allergic rhinitis), no medications on 11/1/01. On 12/5/01, his 4 year old sister was vomiting 1/2 hour after eating. Grandmother sick with acute viral gastritis. Cause of Death as per autospy report - undetermined. Y 12/12/2001 N 11/28/2001 12/12/2001 14 Autopsy results pending PUB PUB Tylenol 24 hours after immunzation NONE NONE 1
0179130 12/18/2001 NY 40.0 40 M 12/13/2001 No symptoms of adverse reaction noted following administration of vaccine. Autopsy performed and cause of death was listed as "Cardiorespiratory failure as a consequence of seizure". Y 12/01/2001 N 11/30/2001 12/01/2001 1 Autopsy performed PVT PVT Inderal; Metamucil; Ativan; Vitamin E; Cogentin; Risperdal NONE Development disability; severe MR; mild to moderate scoliosis; intermittent explosive disorder; PICA; history of pin worms; allergy to Navane and Nitrous Oxide 1
0179131 12/18/2001 NY 77.0 77 F 12/13/2001 No symptoms of adverse reaction noted following administration of vaccine. Cause of death pneumonia. Y 12/07/2001 N 11/16/2001 12/07/2001 21 PVT PVT NONE Development disability, Down's Syndrome 1
0179132 12/18/2001 ID 43.0 43 F 12/13/2001 A 43 year old female reported that she received a dose of Flu Shield '01-'02 vaccine on 12/10/01. Within 3 minutes, she experienced tingling and numbness in her arm which progressed to her face and left side, difficulty breathing, itching and vision was out of focus. At the date of the report, no further information was available. Tingling, numbness and difficulty breathing are considered "Medically Important Events". Follow-up information received from the vaccine administrator on 01/02/2002, stated that the paitent began to feel numb and tingly in the vaccinated arm as she was leaving the room where she was vaccinated. Then while en route home, she experienced the other symtoms as stated above and went directly to a physician for evaluation. The physician allegedly told the patient that he "didn't know for sure what caused her symptoms". The patient reported to the vaccine administrator that "it took four days for her symptoms to dissipate and for her to feel normal again. Y 12/10/2001 12/10/2001 0 UNK PUB OTH UNK UNK Cow's milk intolerance, Drug hypersensitivity HQ9434212DEC2001 1
0179133 12/18/2001 NY U 12/14/2001 A pharmacist reported that an unidentified pt received an influenza virus vaccine, trivalent, types a and b. Within 2 days of receiving the vaccine, the pt experienced a seizure and was hospitalized. No additional information was available as of the date of this report Y Y U UNK OTH OTH UNK UNK UNK HQ9405612DEC2001 1
0179138 12/18/2001 NM 45.0 26 M 12/13/2001 Information has been received concerning a 45 year old male with allergens allergy who reported that in 2/1983 he was vaccinated with his 3rd Hep-B vaccine. Previous vaccination occurred in 9/1982. Within a day, post vax, in 2/1983, the pt experienced stomach cramps (which lasted for 2 months and became severe) and over the next 10 years experienced headaches, lost weight, was "in a daze most of the time", had joint pain in 1 of his toes, the joint pain progressed, had trouble with his coordination and had eyesight blurring. At the time of this report, the pt was on 40% disability. The pt was seen by his physician but no dx was made. The pt was not on other medications at the time of the vaccination. The pt reported that he was told that the vaccine was experimental at the time of administration. The pt's stomach cramps, headaches, weight loss, in a daze most of the time, joint pain in 1 of his toes, pain progressing, trouble with coordination and eyesight blurring persisted. These symptoms were considered to be disabling. No further information is available. Y Y N 02/01/1983 02/01/1983 0 OTH OTH UNK Allergy WAES01114346 1
0179139 12/18/2001 1.0 1 .0 M 12/13/2001 Information has been received from a nurse concerning her 1 year old son who has an allergy to amoxicillin, multiple food allergies, GERD and a history of asthma. It was reported that the child had problems with vomiting since birth and that the vomiting worsened as his diet changed. On 10/10/00, the child was vaccinated with the 1st dose of MMRII (lot 635919/0825K). There was no concomitant medication. Approx. 30 minutes, post vax, the child developed a rash and was reported to have projectile vomiting most of that night. Unspecified medical attention was sought. At approx. the end of 1/01, the child was hospitalized due to vomiting. The vomiting was thought to be related to the child's allergies which included eggs, all meat except for pork, soy products and dairy products. During this hospitalization, the genetic defect alpha-1 antitrypsin insufficiency was found. The child's fatty liver was related to the vomiting. It was reported that at the child's 1 year check-up his liver enzymes were "near normal". The outcome of the fatty liver, alpha-1 antitrypsin deficiency, rash and vomiting were unknown at the time of this report. Upon internal review, the hepatic function abnormality, fatty liver and alpha-1 antitrypsin deficiency were felt to be serious for an "Other Important Medical Event". Additional information has been requested. The nurse reported that a 36 month old male developed an allergic reaction, coughing, sneezing and his throat felt funny after vaccination with MMRII (see WAES01120223). Y Y N 10/10/2000 10/10/2000 0 Genetic defect alpha-1 antitrypsin-insufficiency was found; liver enzymes were elevated; ultrasound-fatty liver PVT OTH NONE Asthma; vomiting; amoxicillin allergy, food allergy and GERD WAES01120225 1
0179140 12/18/2001 CT 72.0 72 M 12/13/2001 Information has been received from an RN concerning a 72 year old male with a history of pneumococcal vaccine 23 (MSD) 10-15 years ago who on 10/31/01 was vaccinated with pneumococcal vaccine 23 polyvalent, .5cc IM, in the right tricep (lot 636158/1456K). That night, the pt experienced pain and developed inflammation, redness and swelling at the injection site and was unable to raise his arm. The nurse reported that the pt treated the area with an ice pack 20 minutes on and 20 minutes off. On 11/1/01, the pt noted fluid bubbles on his right upper arm. The pt was seen at the ER the next day and the fluid bubble had extended to his elbow. The pt was dx'd with cellulitis and therapy with cephalexin (Keflex) was started. The pt was treated as an outpatient, never hospitalized. On 11/9/01, the pt's sister reported to the RN that the pt's cellulitis was resolving well. The nurse reported that the pt's sister and 2 other consumers received pneumococcal vaccine 23 polyvalent at the same location on the same day and experienced pain at the injection site (WAES01110493 and WAES01111426) (lot 636158/1456K). The reporting RN felt that cellulitis, pain, redness and swelling were considered "Other Important Medical Events". In follow up information received the registered nurse reported that the patient was recovered from cellulitis, pain, redness, swelling, weakness and injection site inflammation. The nurse reported conflicting information that the pt received therapy with pneumococcal vaccine 23 polyvalent on 10/23/01. The reporter expressed that the patient stated that he was concerned about the lot. The records of testing prior to release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released. No further information is available. Y Y 10/31/2001 10/31/2001 0 OTH OTH UNK WAES01111425 1
0179141 12/18/2001 WI 13.0 M 12/13/2001 Information has been rec'd from a physician concerning a 13 yr old male with chronic bronchial asthma who on 11/23/01 was vaccinated with one dose of pneumococcal vaccine2 polyvalent (lot # 6372631448K) in the L deltoid. Concomitant therapy included montelukast sodium, (MSD) (duration, dose and indication not reported). Other concomitant therapy included fluticasone propionate (*) salmeterol xinafoate (Advair), budesonide (rhinocort) and albuterol. On 11/25/01, 2 days post vaccination, the pt was seen in the ER for severe cellulitis 15cm diameter at site with pain and a fever on 104F. The pt rec'd treatment with an IV cephalosporin and was released with an oral cephalosporin, acetaminophen (tylenol) and warm compresses. The pt was seen again in the ER on 11/27/01 because the cellulitis had not improved. The pt rec'd treatment with IV cephalosporin and was released with oral cephalosporin, acetaminophen (tylenol) and warm compresses. The physician noted that this was the 1st injection to be used from the multi-dose (pneumococcal vaccine 23 polyvalent) vial. No one else had rec'd the vaccine from this vial and the physician was holding the vial. The physician asked if there ere any recalls and if a culture should be done on the vial. The physician requested a response or follow-up on the vial and lot number check. Follow up information noted that after two courses of IV antibiotics plus an oral antibiotic course, the patient recovered on 11/30/01. The records of testing prior to release of this lot have been checked by GMP Compliance and found to be satisfactory. This lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Upon internal review, the patient's severe cellulitis 15cm diameter at site was determined to be an other important medical event. Additional information has been requested. Y Y 11/23/2001 11/25/2001 2 Temperature 11/25/01-104F OTH OTH Albuterol; Rhinocort; Advair; Singulair Asthma WAES01114402 1
0179142 12/18/2001 NV U 12/13/2001 Information has been received from a medical assistant concerning 5 pts who were vaccinated with pneumococcal vaccine 23 polyvalent. The pts developed cellulitis and were treated in the local ER. No other information was available at the time of this report. Upon internal review cellulitis was determined to be an "Other Important Medical Event". Additional information has been requested. In follow up the MA reported that she has no additional information regarding these cases. She stated that shewas the initial person who reported these events but a nurse in the practice finished the reporting. She further stated taht the medical practice was closing at the end of January 2002 and the nurse would only be in the office one day next week. Upon internal review, cellulitis was determined to be an other important medical event. No additional information is available. U OTH OTH UNK UNK WAES01114477 1
0179148 12/18/2001 MD 0.3 0 .3 M 12/17/2001 10/05/2001 Fever for 24 hours after 2 month vaccines. 12/02/2001 admitted 48 hours after 4 month vaccine with T 104 and suspected encephalitis. Y 3 Y 12/07/2001 12/09/2001 2 CSF-WNL; Sepsis work-up (-) PVT PUB NONE NONE NONE Fever~DTaP (no brand name)~1~0.00~In Patient 1
0179149 12/18/2001 GA 0.2 0 .2 M 12/14/2001 Prsented to office 12/13/2001 for 2 month checkup where he received Prevnar, DTaP, Comvax and IPV. Went to ER where he was admitted with febrile illness prob secondary to immunizations and sepsis. Note: Medical record does not substantiate a diagnosis of sepsis. Y Y Y 12/13/2001 12/13/2001 0 PVT PVT Zantac; Gentian Violet Reflux; oral candida NONE 1
0179150 12/18/2001 NY 0.2 0 .2 F 12/10/2001 The pt developed respiratory distress and was not feeding well. She required intubation in ER. The pt had a history of myotonic dystrophy. Y 16 Y 12/05/2001 12/06/2001 1 PUB PUB NONE Myotonic dystrophy Myotonic dystrophy 1
0179151 12/18/2001 OH 57.0 57 M 12/17/2001 Guillain Barre syndrome, axonal form. Per doc 214332, 60 day follow-u, patient was discharged to a rehabilitation facility. He reportedly died several days later. I am unsure at the cause of death, though I suspect he may have suffered a massive pulmonary embolism. Y Y Y Y Y N 11/02/2001 11/29/2001 27 NONE PUB PVT metformin; allopurinol NONE 1
0179152 12/18/2001 GA 30.0 31 F 12/14/2001 Pt received both Pneumovax and flu vaccines in left arm. She developed erythema, requiring hospital admission and IV antibiotics. Resolved. Y 1 Y 12/07/2001 12/09/2001 2 Blood culture negative PVT UNK 1
0179153 12/18/2001 TN 59.0 59 F 12/06/2001 Client received pneumonia vaccine on 12/03/2001 around 11:30 in the morning. Approximately three hours later, she started experiencing chills and a fever. The latter reached 102 and lasted for twenty-four hours. A swollen area of redness was noted about two inches below the injection site. The underside of the left arm was also tender to the touch. This tenderness lasted for two days after the vaccination. Y Y 12/03/2001 12/04/2001 1 On 12/06/01, the patient saw Dr., who feels that the Adverse Event was a systemic reaction. He recommended anti-inflammatory treatment, in the form of Tylenol and heat. He also recommended that the patient not receive the pneumonia vaccine in the future. PUB PUB None PCN, Erythromycin, Recently recovered from pneumonia GA01112 1
0179154 12/18/2001 GA 65.0 65 F 11/06/2001 The patient experienced a local reaction to the right upper arm. The slight swollen area was red and warm to the touch. Y Y 11/02/2001 11/03/2001 1 None PUB UNK None None GA01106 1
0179155 12/18/2001 AL 48.0 48 F 11/05/2001 Complained of numbness around mouth, approximately 2 minutes after flu shot was administered. Exhibited difficulty talking. Pulse 100, BP 152/90. Pt also complained of very dry mouth, Was given Benadryl 50 mg IM and transported to ER by family members. Y Y 11/05/2001 11/05/2001 0 PUB PUB Synthroid, Detrol, hormone shot every month NONE Codeine allergy GA01104 1
0179156 12/18/2001 GA 36.0 36 F 10/13/2001 Flu shot given @ approx. 2:20pm. By approx. 3:00pm. Pt developed headache, flushing, numbness, in lips & stated "my throat feels like it's closing up".Benadryl 50mg IM given & pt transported to at ER. Pt was observed for approx. 2 hrs & released. Y Y 10/31/2001 10/31/2001 0 u/a done @ CRMC - ER OTH PUB N/A NO Cipro, Amoxicillin Dx- fibromyalgia, migraine, headaches flu like sympoms~Influenza (Seasonal) (no brand name)~~0.00~In Patient GA01102 1
0179157 12/18/2001 NC 52.0 52 F 12/04/2001 Pt rec'd influenza and pneumococcal vaccines L upper arm 11/7 called 11/8 reporting pain no fever, no local warmth. Seen 11/9 c/o fever, responding to ibuprofen 2 areas erythema L upper arm slightly warm, very tender. CBC and blood culture drawn. Cephalexin 500mg bid x 7 days; resolution of fever 24 hrs resolving pain and redness 5 days. Y Y 11/07/2001 11/08/2001 1 CBC w differential -normal, blood culture no growth (11/9/01) PVT PVT Prozac, vioxx, ibuprofen NONE NKDA. menopause, lumbar disc disease NC01106 1
0179158 12/18/2001 NJ 28.0 28 F 12/11/2001 12/07/2001 developed 3 hives on left leg. On 12/08/2001 hives itching developed arm, lower axilla, back and legs. Zyrtec D 120 mg q 12 hours for 4 days. Zyrtec 10 mg TID for 4 months. Y N 12/07/2001 12/07/2001 0 NONE PUB PUB NONE NONE NONE 1
0179159 12/18/2001 AL 55.0 55 F 12/16/2001 Second day soreness and redness at site that got worse traveled into the arm, to the shoulder and up into the neck, all happened over a 3 week period. Still have pain in right side of neck, arm has pain to the touch and when laid on. Hurts to pick anything up. Pain traveled from injection site into the shoulder, slight swelling in the neck area. Still having pain. Y N 11/06/2001 11/07/2001 1 PVT PVT NONE Hypertension, asthma and diabetic. 1
0179160 12/18/2001 NE 50.0 50 F Nausea and vomiting Y Y 11/06/2000 11/07/2000 1 OTH OTH 1
0179161 12/18/2001 TX 46.0 46 M 12/14/2001 Pt rec'd immunizations 12/10/01, same day (evening) had onset of fever, chills, weakness. Symptoms resolved by next morning. Y 12/10/2001 12/10/2001 0 OTH OTH gabapentin 300mg po tid NONE Allergic to saccharin, bee stings 1
0179162 12/18/2001 WA 48 M 12/11/2001 Pt called in, reported he was having a reaction to a vaccine he received on 12/4/01 in L arm. Review of record determined it was the pneumonia vaccine. Pt c/o redness, soreness, swelling and streaking. Advised to f/u w/MD. Saw MD - no recommendation or f/u necessary, Adverse reaction. Y Y 12/04/2001 12/05/2001 1 NONE PUB OTH NONE NONE 1
0179163 12/18/2001 NY 52.0 52 M 11/20/2001 Pt received flu immunization right deltoid IM approximately 5 PM on 11/15/2001. Friday night 11/16/2001, developed "itchy red spot" right deltoid area. by Saturday AM 11/17/2001 developed itchy all over both arms. By 8:30 PM Saturday 11/17/2001, has itching and red blotches which pt calls hives over entire body. Took honey and oatmeal solution bath, applies ointment an this called itching. Seen 11/18/2001 4:45 PM itching and blotches reappeared. Repeat Bath and ointment helped very little. At 10 PM pt went to ER. He was given Prednisone 20 mgm bid PO for 5 days. He has appointment with PCP on Friday 11/23/2001. Pt reports he continues to have breakthrough itching and blotches between doses of Prednisone. Has occasionally taken Benadryl for itching. Pt works in a lumber yard: is exposed to wood products, insulation, paints, stains, chemicals and concrete building products. Pt also works at building construction. Y N 11/15/2001 11/16/2001 1 NONE PUB PUB Thyroid; Bufferin Multiple Sclerosis NYS21023 1
0179164 12/18/2001 OH 39.0 39 F 11/30/2001 On 11/29/01 at 11:00, the pt felt shaky, light-headed, fever and body aches. Seen by MD at 14:40. Pt states she also "feels heavy in my chest". Y U 11/28/2001 11/29/2001 1 PVT PUB Advair; Asthmacort; Univasc; resperolol; diazepam; Paxil; Remeron Resolved sinusitis; asthma; HTN; fibroid tumors; depression; Dyslipidemia OH0072 1
0179165 12/18/2001 MD 29.0 29 F 11/19/2001 The injection site started to itch and she scratched it. The area is warm to the touch, reddened and slightly swollen. She is still recovering. N 11/12/2001 11/13/2001 1 PUB OTH NONE NONE 1
0179166 12/18/2001 AL 63.0 63 F 12/07/2001 Patient experienced a localized reaction of 6 cm X 5 cm on the left deltoid. The area was erythemic and warm to palpitation. Treatment included observation and ice packs. Y 11/15/2001 11/16/2001 1 N/A PVT PVT Lipitor, Premarin None ASA-antihistamines-codeine-morphine. elevated cholesterol, menopausal 1
0179167 12/18/2001 MI 25.0 25 M 11/29/2001 The pt complained of left arm being limp, unable to use without increased pain. He had swelling in his left hand. He came to the clinic and was seen on 11/28/01. Ordered Benadryl 3tsp q 4-6 hours. Return to clinic if unresolved. Pt didn't return for visit or return phone calls to him. Y 10/27/2001 10/28/2001 1 CPK; CBC; CMP-all wnl PUB PUB Humulin 70/30; Nexium 40mg; Zoloft 25mg Diabetes Mellitus Diabetes Mellitus, GERD, Depression 1
0179168 12/18/2001 ND 70.0 70 M 12/11/2001 The pt said his right arm was swollen down to his elbow and real sore. He said his arm got "flabby" like jello and he couldn't lift his arm above his waist. He said it hurt the day the vaccine was given and the next day and then it got better. Y 11/15/2001 11/15/2001 0 PVT OTH NONE 1
0179169 12/18/2001 OH 44.0 44 F 12/06/2001 Patient received the flu vaccine at her workplace(factory). It was administrated by personnel from DeKalb Memorial Hospital. A 5 1/2 x 4 1/2 cm redness lump developed U 11/27/2001 11/29/2001 2 UNK UNK 1
0179170 12/18/2001 VA 42.0 M 12/03/2001 Post vax, the pt developed diarrhea and cramping. He also had a fever, nausea and dizziness. He had a ear infection and a head cold. Y N 10/22/2001 10/22/2001 0 OTH OTH pseudoephedrine; Benadryl NONE Chronic sinusitis 1
0179171 12/18/2001 GA 44.0 44 F 12/11/2001 Pt developed a 3" X 3" red, warm and swollen area over the injection site with some swelling around axilla. It started the morning after the injection. Treated with warm and wet compresses. Y 12/06/2001 12/07/2001 1 PUB PUB UNK NONE Respiratory problems 1
0179172 12/18/2001 NE 0.8 0 .9 F 12/11/2001 The pt developed a fever of 102F on Sunday after receiving the Flu-Shield on Saturday, 12/8/01. It is persisting despite Tylenol alternating with Motrin q 6 hours. Y Y 12/08/2001 12/09/2001 1 PVT PVT NONE NONE Frequent otitis media 1
0179173 12/18/2001 SD 56.0 56 F 12/06/2001 The pt had a flu shot on 12/4/01. She called on 12/6/01 and complained of redness, swelling and tenderness in her left upper arm where the injection was given. The pt came in to the clinic and I assessed her arm. Her upper left arm had a 3" by 2" patch of redness which was swollen, warm and tender to the touch. Recommended ice to site and to see her MD if it doesn't get better or if it gets worse. U 12/04/2001 12/06/2001 2 PUB OTH Allergy shot taken once a week for environmental allergies NONE Environmental allergies (dogs, ragweed) SD01007 1
0179174 12/18/2001 AL 0.2 0 .2 M 12/09/2001 Screaming, crying spells > 3hrs, local rxn- 1cm induration w/erythema Y 08/14/2001 08/14/2001 0 PVT PVT NONE NONE 1
0179175 12/18/2001 NE 0.3 0 .3 M 12/11/2001 5 minutes, post vax of 4 injections, the child became limp and blue with very shallow breathing. Called 911. O2 was applied and within 2-3 minutes, the child pinked up. O2 sats were 100%. Watched for 15-20 minutes. No additional problems. Y Y 12/11/2001 12/11/2001 0 PVT PVT NONE 1
0179176 12/18/2001 OH 1.25 1 .3 M 12/12/2001 Pt had a febrile seizure. Y Y 12/05/2001 12/07/2001 2 WBC-11.4; NA-137; K-4.8; Cl-100; CO-219; Glucose-123; U/A-nml; pulse ox-98%; temperature-38.6C PVT PUB NONE URI FTT 1
0179177 12/18/2001 KY 0.2 0 .2 M 12/13/2001 approx 10 hrs after receiving vaccinations pt broke out in a rash covering most of his body. The pt was very fussy, crying most of the day. The rash lasted approx 24 hrs. Y Y 12/05/2001 12/05/2001 0 NONE PVT PVT NONE NONE NONE 1
0179178 12/18/2001 ME 1.8 1 .8 F 12/11/2001 The pt awoke in the AM of 12/8/01 and her grandmother noted left thigh was swollen and red. She called and the pt was seen in the office. She had received Prevnar vaccine on 12/6/01 in the left thigh (lat) and it was swollen, red and warm to the touch, approx. 8cm X 12cm. She was started on Duricef X 7 days, Motrin and Benadryl for itching. Talked with mom on 12/9/01 and she stated area was not as red but about the same size. On 12/10/01, seen in office with a smaller than circled area and slight swelling. Redness was pink with no adenopathy or tissue breakdown. Y Y 12/06/2001 12/08/2001 2 NONE PVT OTH NONE NONE 1
0179179 12/18/2001 DE 0.3 0 .3 F 12/11/2001 The patient's right thigh was red, hot and swollen. A raised area, oval in shape,with the measurements of 1" long X 1/2 wide was noted. Throughout the night, she was lethargic and irritable. This morning, the mother was instructed to give 0.8 ml of Infants tylenol. The first dose is suppose to be given at 9:15 A.M. , with a subsequent doses at 12:15. Warm compresses were also to be applied to the area. Y 12/10/2001 12/10/2001 0 PVT PVT Reflux 1
0179180 12/18/2001 VA 0.5 0 .5 F 12/12/2001 Fever 103 for 24 hrs. Crying episodes lasting 3-4 hrs, redness and swelling at injection site. Y 12/05/2001 12/05/2001 0 N/A PVT PVT 1
0179181 12/18/2001 FL 0.3 0 .2 F 12/14/2001 The pt developed a small nodule on her right thigh. U 09/20/2001 09/22/2001 2 PVT PUB NONE NONE NONE 1
0179182 12/18/2001 SC 54.0 54 F 12/12/2001 Went to bed at 21:30 on 12/12/01 and was restless and arm ached. At 02:00, I woke up with dry heaves and chills. On 12/13/01, I was very weak. I am feeling stronger each day with intermittent nausea, headache and dizziness. I am still experiencing symptoms. N 12/04/2001 12/05/2001 1 NONE PUB OTH Prilosec; Nexium; Altace; Advair; Atrovent; Mucofen; E-vista; Paxil; Vitamin E; Calcium NONE Asthma; hypertension; breast cancer in 2000 1
0179183 12/18/2001 GA 4.0 4 F 11/30/2001 Mom noticed that L arm (DTaP) was extremely red and swollen 11/29/01 night. She states arm (deltoid area) on up into shoulder was red, swollen and hot. She took child to the ER. Dr gave her benadryl & motrin. Arm noted w/redness & swelling about 50 cent piece size. Y Y 11/28/2001 11/29/2001 1 PUB PUB NONE GA01111 1
0179184 12/18/2001 GA 1.3 1 .4 M 11/21/2001 On 11/21/2001, at 8 am, patient's parent reports that his child's left arm was warm to the touch and swollen. When they came into the clinic around 12:50, patient's arm was noted to be warm to the touch and red from the shoulder to about two inches from his elbow. Y Y 11/20/2001 11/21/2001 1 N/A PUB UNK Albuterol None Asthma GA01110 1
0179185 12/18/2001 GA 2.0 2 .2 F 11/14/2001 On 11/14/01, MD was sent a note stating the child had a cold. Mom said she had a temperature the night before of 100.5F, stuffy nose and chest congestion. Received shots on 11/13/01. Note also stated that the child had lower lateral thigh and right upper medial thigh was swollen and tender. Also said that child had asthma. She faxed the doctor a copy of "after the shots". Y 11/13/2001 11/14/2001 1 PUB PUB NONE Had a little cold NONE GA01109 1
0179186 12/18/2001 GA 4.8 5 M 11/13/2001 The pt developed a large local reaction at the site of the DPT, requiring about 2 weeks for full resolution. This was the pts 5th DPT. Y 09/27/2001 PUB OTH GA01108 1
0179187 12/18/2001 GA 4.0 4 M 11/08/2001 Redness & warmth to 1/3 upper R arm. Active no other S&S. Tx: ice to area/benadryl. Y U 11/06/2001 11/07/2001 1 NONE PUB PUB NONE NONE NONE GA01107 1
0179188 12/18/2001 GA 1.0 1 .0 M 11/02/2001 On 10/28/01 at 02:00, his temperature was 102.7F (ax). He had a fever all day. On 10/29/01, he developed a rash on extremities with a little on his trunk. He saw the MD on 10/31/01 and was told that he possibly had a virus. His temperature on 11/1/01 was 98.9F. Y Y 10/26/2001 10/28/2001 2 NONE PUB PUB NONE Frequent OM and has tubes in ears. GA01105 1
0179189 12/18/2001 GA 4.0 4 M 09/14/2001 Mother noticed redness and swelling of left upper arm near shoulder 09/13/2001 PM. Area is red, swollen, warm to touch. Child denies discomfort. Y Y 09/12/2001 09/13/2001 1 PUB PVT NONE NONE History of Febrile Seizures GA01103 1
0179190 12/18/2001 GA 47.0 47 F 10/30/2001 Pt has a 2cm X 1cm red, raised, itching wheal on upper, posterior aspect of right upper arm. It was 1st noticed by the pt on 10/19/01. On 10/23/01, it was measured by clinic nurse and it was 2cm X 1 1/2cm. It was treated with topical application of hydrocortisone cream. On 10/15/01, PPD was placed on left forearm. PPD-OMM on 10/18/01. Temperature was 100.5F-101F on 10/19/01 until 10/21/01. Y Y 10/18/2001 10/19/2001 1 PUB PUB PPD on 10/18/01 in left forearm NONE Allergy to codeine; history of spinal fusion for herniated disc secondary to trauma GA01101 1
0179191 12/18/2001 CA 65 F 12/10/2001 11/30/01 malaise , lightheaded, 12/1/01 no change, 12/2/01 stated slight cough, 12/4-12/6/01 hoarseness, chest congestion started 12/4 & cough productive (yellow-green) no F/U lump on neck since 12/6 R knee twisted in bed 12/6 better now. apparently better today. Treated for URI and released. Y 11/09/2001 12/11/2001 32 negative titer for rubella 10/30/01 PVT PUB NONE NONE 1
0179192 12/18/2001 CA 2.0 2 .2 M 12/07/2001 R thigh + swelling and erythema with induration around injection site 12x14cm. Pt able to walk well. Y 11/12/2001 11/13/2001 1 OTH PUB NONE NONE NONE CA010136 1
0179193 12/18/2001 MN 8.0 9 F 12/10/2001 12/06/2001 12/06/2001 0 Extremely large local reaction of L deltoid muscle. Swollen, tender, hard. treated as cellulitis. PVT PVT naprosyn, albuterol ?? J rheumatoid arthritis 1
0179194 12/18/2001 NH 1.0 1 .1 F 12/13/2001 12/06/2001 4:40 PM Benadryl 125 mg PO given at 4:55 PM. Y 12/06/2001 12/06/2001 0 NONE UNK UNK NONE NONE NONE 1
0179195 12/18/2001 WV 0.3 0 .3 M 12/06/2001 Child cried continuously with high pitch cry for 1 day. No other symptoms. Diagnosis: reaction to Pertussis. Y Y 12/04/2001 12/04/2001 0 PUB PUB NONE NONE 1
0179196 12/18/2001 AZ 54.0 54 F 12/11/2001 Polyarthralgia and Polyenthesopathy U 07/16/2001 08/25/2001 40 all serologic tests c-1 PVT PVT Routine Vaccination None 1
0179197 12/18/2001 IL 53.0 53 M 11/27/2001 Four hours after pneumonia vaccine arm swelled (size o an orenge), fever 103 for two days. Home from work. Had chills. Y 11/03/2001 11/03/2001 0 OTH OTH NONE 1
0179198 12/18/2001 PA 0.3 0 .3 M 12/13/2001 Child exhibited uncontrollable crying for approximately 6 hours accompanied by a fever varying from 102 to 103. Fussy for approximately 24 hours. Y 12/10/2001 12/10/2001 0 NONE PVT PVT NONE NONE NONE 1
0179199 12/18/2001 MT 67.0 67 M 12/12/2001 By 8pm pt c/o sore arm 12/10/01 tried heating pad 3pm 12/11 - redness and swelling by 8pm 12/11. Pt in to see Dr 12/12 @ 9am. Keflex 250mg tidx5 instructed to ice site. Y Y 12/10/2001 12/10/2001 0 NONE PUB PUB NONE NONE peripheral neuropathy - unknown cause 1
0179200 12/18/2001 WV 4.0 4 M 12/11/2001 Four to five lesions, itching. Y 02/26/2001 12/11/2001 288 PVT PVT NONE NONE 1
0179201 12/18/2001 CT 5.0 1 .0 F 12/07/2001 Sibling had chicken pox two weeks ago, also vaccinated. On Amoxicillin for strep 12/03/2001. Six marks on trunk and face. Started 12/06/2001. Diagnosis: chicken pox. Pt has allergy to peanuts and cashews. U 01/03/1997 PVT PVT NONE NONE NONE 1
0179202 12/18/2001 AZ 3.0 3 M 12/05/2001 Swollen right arm with erythema. U 12/05/2001 12/05/2001 0 PVT PUB NONE 1
0179203 12/18/2001 WA 0.3 0 .3 M 12/10/2001 Four month old male who had received DTaP #1, HIB #1, IPV #1, HBV #1. HBV #2 and PCV #1. In office received DTaP #2, HIB #2, IPV #2 and less than 60 seconds later developed urticaria on head and neck. No respiratory distress. Observed for 20 minutes with almost complete resolution of symptoms. Y 12/06/2001 12/06/2001 0 NONE PVT PUB NONE NONE NONE 1
0179204 12/18/2001 WA 70.0 70 F 12/10/2001 Undue pain and swelling and redness of left arm, which is presently resolving, but not completely gone. N 12/08/2001 12/08/2001 0 NONE PVT PVT Actonel; premarin; Prednisone; Claritin NONE Phenothiazine-can't breathe or talk; Polymyalgia Rheu. 1
0179205 12/18/2001 MD 4.0 1 .0 F Pimple like lesions began eve of 11/26/2001 and more noticed next morning. Seen in office 11/27/2001 and had 10-12 lesions that were papular with central puncta on face, trunk, back, LLE that were itchy and painful. Seen 2 days later with 20-30 lesions, a few crusted over. Diagnosed with Varicella. Family found exposure at day care. Recovered within 7 days. Y 11/06/1998 11/26/2001 1116 OTH PUB NONE NONE 36 week premature 1
0179206 12/18/2001 CA 11.0 11 M 11/27/2001 Pt received TD, Hep A dose 1 and Hep B dose 3 on 11/21/2001. A few minutes after, pt fell on the floor and had jerky movements of lower extremities for a few seconds only, afterwards he felt a little bit weak but is awake, alert and coherent. Pt is referred to ER for further evaluation. Y Y 11/21/2001 11/21/2001 0 Blood glucose 105; Blood hemoglobin 14 PUB PUB NONE 1
0179207 12/18/2001 TX 69.0 F 12/10/2001 Pnu-Immune given 10/02/2001. Presents to clinic 10/04/2001 with cellulitis of left upper arm. Given Cipro for treatment (Pt is allergic to PCN). Y 10/02/2001 10/04/2001 2 PUB OTH PCN; cephalosporins 1
0179208 12/18/2001 VA 5.0 4 F 12/12/2001 Redness and swelling at site of MMR, 24 hour duration. Y 11/29/2001 11/29/2001 0 PVT PVT 1
0179209 12/18/2001 TX 81.0 F 12/10/2001 Cellulitis developed 24-48 hours later in same area of vaccination injection. Y 09/12/2001 09/13/2001 1 PUB OTH PCN, sulfa, Levaquin 1
0179210 12/18/2001 NC 39.0 39 M 11/09/2001 On 30-JUL-2001 the pt received his first injection of Twinrix. When he returned for his second injection of Twinrix he reported that he developed yellow eyes on 01-AUG-2001. He also reported that the yellow eyes resolved on 03-AUG-2001 without treatment. The Twinrix immunization series was discontinued and the pt was referred to a gastroenterologist. the most recent information was received from the vaccine provider on 07-NOV-2001. the vaccine provider considered the event to mild in intensity and possibly related to Twinrix administration. Yellow eyes is considered medically serious. Y Y 07/30/2001 08/01/2001 2 PUB PVT 20010214571 1
0179211 12/18/2001 CA M 12/21/2001 Medical history reportedly included Ramsay Hunt Syndrome following receipt of Hep-B vaccine (brand name unknown) in 1990 (see report 20010265342). Concurrent conditions and medications were not specified. In 10/01 (exact date unknown), the vaccinee received his 1st injection of Twinrix. An unspecified time, post vax, the pt reportedly developed facial paralysis. It was not known if he had sought medical attention. The outcome of the event was not known. U 10/01/2001 10/01/2001 0 OTH OTH Ramsay Hunt Syndrome (1990) 20010265341 1
0179213 12/19/2001 WA 34.0 34 F 12/12/2001 Unexplained death. Awaiting autopsy COD as per autopsy report -- combination of methadone and oxycodone intoxication Y 12/11/2001 N 12/10/2001 12/11/2001 1 Autopsy-pending PVT PVT Sulfa allergy 1
0179214 12/19/2001 OK 41.0 F 01/02/2002 It was reported that a 41 year old female pt received a dose of Fluzone SV '01-'02 on 10/30/01. On 11/20/01, the pt experienced numbness in her hand. On 11/27/01, she went to a hospital ER with shooting pains in her hand (reporter did not know which hand or if it was the same arm the dose of Fluzone was administered in). The pt was dx'd with brachial neuritis. This was considered to be an "Other Important Medical Event". From follow up correspondence received on 1/2/02, it was confirmed that the numbness in the patient's hand occurred in the same arm that the Fluzone product was administered. The vaccine administrator and responsible physician information was also provided. 8/11/03: No additional info is anticipated. AE coding was changed. "Brachial plexus neuropathy" is listed in the labeling for the influenza vaccine. Case is closed. Y U 10/30/2001 11/20/2001 21 X-rays and blood work were done (no results were provided). OTH OTH U2001012610 1
0179217 12/19/2001 AL 0.2 0 .2 F 11/09/2001 The pt was found apneic and pale at daycare. She required mouth-to-mouth resuscitation. In ER, she was noted to have decreased activity and color. Y Y 3 Y 10/26/2001 11/02/2001 7 EEG; CXR-nml; Blood culture-neg PVT PVT NONE NONE 1
0179218 12/19/2001 SC 18 M 12/13/2001 Tightness in throat, urticaria face and neck, wheezing, periorbital swelling. Given IM Solumedrol and albuterol treatment. Y Y 12/10/2001 12/10/2001 0 Chest x-ray, EKG, ?? PVT OTH NONE NONE NONE 1
0179219 12/19/2001 IL 0.2 0 .2 F 11/30/2001 The pt had left-sided seizure activity on 11/7/01 (twitching of left arm) then was limp for a few minutes and emesis. The pt was admitted to the hospital. She was discharged on phenobarbital. The pt developed episodes compatible with infantile spasms. Evaluation and treatment ongoing. Per 1 year follow up: Pt did not recover. Persistent seizures. Diagnosis of infantile spasms. Y U 10/22/2001 11/07/2001 16 EEG; MRI; CT Scan; sepsis evaluation-all nml; Alkaline phosphatase-772; 2nd EEG-confirms symptoms compatible with infantile spasms. PVT PVT NONE NONE NONE 1
0179220 12/19/2001 NJ 1.0 1 .3 M 12/13/2001 Pt developed a fever (105 or more) and then a seizure. He was treated for the sizure at a different facility. Y Y 11/28/2001 12/08/2001 10 PVT UNK 1
0179221 12/19/2001 CT 68.0 68 F 12/13/2001 Pt stated discomfort noted in L shoulder area 3-4 days after flu shot rec'd in L arm. Pt observed bruise in area near top of shoulder, but no swelling. States she experienced limited movement of L arm. Went to Dr 12/10/01 who diagnosed tendonitis and prescribed home exercises. Pt states now w/neck pain and states MD said this is related to the shoulder pain. Small flat purple discoloration seen today by me at top of L shoulder area. Y U 10/23/2001 10/26/2001 3 PUB PUB some arthritis CT200109 1
0179222 12/19/2001 OH 45.0 45 F 12/11/2001 After hot bath following day -R thigh red, welted, tender approx 2" round circle - lasted 2 wks. No treatment Y 11/23/2001 11/24/2001 1 PVT OTH Eftexol, Xanax, Trazadone, Biaxin XL Bronchitis sulfa, CP, depression 1
0179223 12/19/2001 OH 63.0 63 F 12/12/2001 pain, bruised, red Y 12/10/2001 12/10/2001 0 not applicable OTH OTH Glucophage, Lodine Tagament diabetes 1
0179224 12/19/2001 SC 70.0 69 M 12/12/2001 The patient experienced a sharp pain in his right arm upon any movement. he state it "feels like the bone is injured". No swelling,redness, discoloration or warth were noted at/around the injection site. There was nothing to palpitate. Y 10/23/2001 11/06/2001 14 PUB OTH UNK None UNK 1
0179225 12/19/2001 CA 28.0 28 F 24 hrs post injection, felt itchy all over body, rash in patches all over. 48 hrs later symptoms exist, took Claritin (10mg) tablet. Y 12/10/2001 12/11/2001 1 OTH OTH yasmin Allergies: strawberries, shrimp, minocycline 1
0179226 12/19/2001 CT 11.0 11 M 12/13/2001 The pt had an onset of a erythematous, nodule, lesion at the site of the injection progressing to vesicular eruption about 24 hours, post vax. The lesion lasted for a week. It was treated with cool compresses. He has received Influenza vaccine yearly since 1992. No known egg allergy. Y 11/23/2001 11/24/2001 1 Vesicular fluid sent for a viral culture and a bacterial culture and both were negative. He had a Tczanck Prep which also was negative. PVT OTH Albuterol MD2; Baclofen; Dulcolax Supp; Ditropan; Renacidin irrigation; Senna; Sorbital; Dical-D NONE Spinal cord injury; ventilator dependent; autonomic dysreflexia secondary to spinal cord injury 1
0179227 12/19/2001 KS 47.0 F 11/15/2001 Found pt lying on floor in room, c/o being thirsty & appears to be hyperventilating. c/o tightness and extremities stiffening up. .5 of epinephrine given & 911 called BP 92/50, 180/102 post epi. EMS on seen & taken to hospital at 07:40. Y Y 11/15/2001 11/15/2001 0 OTH PVT NONE NONE 1
0179228 12/19/2001 MD 45.0 45 F 12/14/2001 The same day I rec'd vaccine the following occurred redness, swelling, tenderness @ deltoid area, febrile 101F, nausea, vomiting. All occurred within 8 hrs also severe headache 5pm. Then developed skin lesion on side of face near nose, which had trouble healing. Continued low grade fever and generalized malaise for 2 wks. Reported incident to private physician. My R deltoid remained swollen, tender for week. Y 10/16/2001 10/16/2001 0 MIL OTH Synthroid, catapril NONE Migraine headache, discoid lupus, Hx thyroid goiter 1
0179229 12/19/2001 25.0 25 M 12/04/2001 reactive arthritis - diffuse joint pain & malaise Y N 11/27/2001 CBC, ESR,Negative MIL MIL NONE NONE 1
0179230 12/19/2001 NY 23 F 11/28/2001 Given the Flu vaccine in the early PM of 10/31/2001. By 7:30 PM that evening pt states she had severe chills and a fever about 103. Severe flu symptoms. Still ill on 11/1/2001 chills and fever. Back to work 11/02/2001, feeling better. Did not go to MD. Y 10/31/2001 10/31/2001 0 PUB PVT NONE 1
0179231 12/19/2001 WA 72.0 72 M 12/13/2001 The pt may have had a mild Guillain-Barre. He was weak and couldn't squat. He recovered without any paralysis or neuro-sensory changes. Y 11/23/2001 12/04/2001 11 PVT PVT Allopurinol; Prilosec; colchicine; Vasotec; ASA; atenolol; procainamide NONE None that should do this 1
0179232 12/19/2001 MD 51.0 51 F 12/10/2001 Post vax, the pt complained of hives all over her body with a pruritic erythematous rash all over body. U 11/28/2001 12/07/2001 9 NONE OTH OTH PCN causes edema 1
0179233 12/19/2001 NH F 12/16/2001 The pt developed a reddened, firm, warm and elevated area. Treatment with ice application. Y 10/30/2001 11/01/2001 2 OTH OTH NONE 1
0179234 12/19/2001 NH F 12/16/2001 The pt developed a quarter-sized reddened, slightly firm and warm area. Y 10/30/2001 11/01/2001 2 OTH OTH NONE 1
0179235 12/19/2001 NH 38.0 38 F 12/16/2001 The pt developed vomiting and blood-shot eyes. Y 10/31/2001 11/01/2001 1 MIL OTH NONE 1
0179236 12/19/2001 NH F 12/18/2001 The pt developed a large, red and firm area, noted to be pink and diffuse. Y 10/30/2001 11/01/2001 2 MIL OTH NONE 1
0179237 12/19/2001 NH 25.0 25 F 12/18/2001 The injection site was hot, red and sore for a prolonged period of time. Y 11/01/2001 11/04/2001 3 MIL OTH NONE 1
0179238 12/19/2001 NH 49.0 48 F 12/16/2001 The pt developed a fever, lump on arm X 2 days, headache and weakness. U 10/30/2001 11/02/2001 3 MIL OTH NONE 1
0179239 12/19/2001 NH F 12/16/2001 The pt developed a 4cm X 2cm reddened and slightly firm area. Treatment with ice application. Y 10/30/2001 11/01/2001 2 OTH OTH NONE 1
0179240 12/19/2001 CA 1 1 U MMR vaccine was given on 11/19/01 and on 11/26/01, the pt developed a fever. On 11/29/01, the pt had a measles rash. Y 11/19/2001 11/26/2001 7 PUB PUB 1
0179241 12/19/2001 SC 1.5 1 .5 M 12/04/2001 One day, post vax, Mom called saying that his leg was red and swollen. Mom took him to MD on 11/9/01 and was told to use warm compresses and Advil. She returned to MD on 11/20/01 when his leg continued to swell. Treated with antibiotics for cellulitis. Seen again on 11/21/01 and his leg was improving. On 12/4/01, talked with Mom and his leg is back to normal. Y Y 11/08/2001 11/09/2001 1 PUB PUB NONE NONE SC0164 1
0179242 12/19/2001 PA 0.6 0 .6 M 12/12/2001 The pt developed red blotches over legs and thigh and abdomen. Y 12/12/2001 12/12/2001 0 PVT PUB 1
0179243 12/19/2001 1.08 1 .1 M 11/29/2001 7 days, post vax, the pt had a temperature of 105.4F (rectal) with listlessness and minimal other symptoms. Y 11/21/2001 11/29/2001 8 CBC and diff-WNL MIL MIL NONE Mild runny nose NONE 1
0179244 12/19/2001 FL 3.0 3 M 11/08/2001 13.5 cm X 13 cm redness and swelling at site. Y 11/05/2001 11/06/2001 1 PVT UNK Pending cramp 1
0179245 12/19/2001 TN 1.0 1 .0 F 12/11/2001 The pt developed a fever of 104.6F, the night of the shots, 12/10/01. On office visit on 12/11/01, erythema was noted at both thigh areas with heat on left thigh 2cm area with 3cm induration on right leg of 1 1/2cm area with 2cm induration. Y Y 12/10/2001 12/10/2001 0 UA-neg (1+ blood on 12/11/01; CBC-WNL; Strept-neg; CXR-Nml PVT PUB Prone to dislocation in knees at birth 1
0179246 12/19/2001 MN 52.0 54 F Minutes after receiving the Lyme vaccination in their right arm, the patient felt tinging in their left arm. within in a few hours, it was red and swollen. The pain spread around their body effecting their knees, shoulders, ankles, back, hand and the other (right) elbow. at the time of this report, their right hand is constantly swollen. they have also experienced from time to time; blurred vision, "horrible" hot flashes, constant fatigue, memory lapses and rashes. Y N 03/26/2001 03/26/2001 0 Negative for Lyme and rhematoid Arthritis PVT PVT None None None 1
0179247 12/19/2001 OR 67.0 67 F 12/12/2001 On the evening of vaccination, the client experienced chills and fever. The following morning, her right arm was swollen and erythema was noted 6" in diameter. The client called the health dept and was instructed to see MD. Per telephone call on 12/7/01, the client's husband reports that she saw MD on 12/6/01 who prescribed an antibiotic, and elevation of arm. Swelling is somewhat reduced today. Per telephone call on 12/12/01, she reports that right arm itches but no other problems. Y Y 12/05/2001 12/05/2001 0 PUB PVT HRT; vitamins NONE NONE 1
0179248 12/19/2001 GA 4.0 4 M 12/17/2001 The pt reported to office on 12/16/01 with right leg bruised, hot and red. Improved from 12/15/01. Received Duricef 25mg BID and oral Benadryl q6. Y Y 12/13/2001 12/14/2001 1 NONE PVT PVT PPD/Aventis/C0914AA/RA NONE NONE 1
0179249 12/19/2001 OR 0.33 0 .4 F 12/12/2001 The patient experienced a firm swollen thigh. Her inconsolable crying started in the first twenty-four hours and lasted between two and three days. Y 11/02/2001 11/02/2001 0 N/A PVT PVT None None 1
0179250 12/19/2001 CA 8.0 8 F 12/13/2001 Pt complained of headache and fever on day following immunizations. Visit to the clinic 12/12/01 indicated probable vaccine reaction. Advil prescribed. Symptoms resolved by following day, (12/13/01). Temp at visit 103.3F Y Y 12/11/2001 12/12/2001 1 NONE PUB PUB NONE NONE 1
0179251 12/19/2001 MN 24.0 24 F 11/30/2001 11/05/2001-patient contacted PHN and explained that they were experiencing head and back ache. they were informed that these symptoms were not usual side effects and referred to Dr. 11/06/2001 Patient went to ER for N & V, headache, backache. they were given Zantac for stomach, Vicodin for pain 12/14/2001-patient discovered she is pregnant. She then notified Merck Y U 11/14/2001 11/15/2001 1 Blood sugar WNL ER visit 11/06/2001 Clinic visit 11/20/01 Abdominal 11/23/2001-normal PUB PUB Avandia glucotrol lipitor INH VitB6 Vomiting/headache/backache type II D.M. Hypercholesteremia intent tuberculosis infection 1
0179252 12/19/2001 CA 43.0 43 F 12/13/2001 MMR given @ pre-employment because of -Rubella titer on 12/5/01 area slight red & itchy after injection, but 3 days later redness larger and progressively getting worse (8 days later) with increased soreness, redness and heat 6x7cm with raised center, increased heat. Seen at urgent care as workers comp and given Keflex. Y Y 12/05/2001 12/08/2001 3 NONE OTH PUB 1
0179253 12/19/2001 MN 1.0 1 .0 M 12/11/2001 MMR rash Y Y 11/29/2001 12/01/2001 2 PVT OTH NONE NONE 1
0179254 12/19/2001 IL 47.0 47 M 12/12/2001 Redness and swelling and induration right deltoid. Pain in neck, shoulders, right arm and fever. Decreased appetite. 12/09/2001 12/12/2001 3 PUB PUB NONE NONE NONE 1
0179255 12/19/2001 FL 0.3 0 .3 F 10/10/2001 Rash on same evening after vaccination. Resolved without treatment. Y Y 10/04/2001 10/04/2001 0 NONE PVT PVT Pediacare URI 1
0179256 12/19/2001 OR 5.0 5 M 12/12/2001 DTaP given right deltoid IM 12/20/2001. Mother noticed arm swollen and red 12/12/2001 and had him come in. Are on deltoid warm, red and swollen 3 by 4 inch tender with pressure. Tx: Ice, Tylenol and Benadryl. Y 12/10/2001 12/12/2001 2 NONE PUB PUB NONE NONE NONE 1
0179257 12/19/2001 PA 6.0 6 M 12/11/2001 Seen 11/29/2001 for vaccine. Doing fine until 12/07/2001. Red, hot to touch, itchy 6 diameter circle. Treatment Zyrtec and Amoxil. Y Y 11/29/2001 12/07/2001 8 NONE PVT PVT NONE NONE NONE 1
0179258 12/19/2001 CO 39.0 39 F 12/12/2001 Fever, chills, area of slight swelling but very tender and red at vaccine site. As of 12/12/2001 oval with 5" diameter of erythema, heat and tenderness. Y N 12/10/2001 12/10/2001 0 PVT PVT Prozac; Neurontin: Notrptyline: Avonex Sinusitis MS, depression and sulfa allergy. 1
0179259 12/19/2001 MA 37.0 37 F 12/09/2001 Five cm erythematous raised macule. U 11/19/2001 11/20/2001 1 PVT UNK NONE NONE 1
0179260 12/19/2001 WI 42.0 42 F 12/07/2001 Fever, headache, swelling at injection site with redness and burning pain. Pt seen again after injection...blister positive and drain. Still indurated on deltoid, lack of full range of motion, 1 cm base, blister evident, deltoid are itching. Y Y 12/05/2001 12/05/2001 0 PVT PVT NONE NONE NONE 1
0179261 12/19/2001 HI 5.0 5 M 12/11/2001 DTaP given on 12/7/2001. On 12/08/2001 at left deltoid pt with redness and swelling. On 12/09/2001 pt with increased itching, erythema and induration. Size about 4 by 4 cm per Mom. Benadryl 1 tsp given once with decreased itching. On 12/10/2001 AM noted to have decreased erythema and swelling but with erythema ring. Erythema multiforme with rash around original... N 12/07/2001 12/08/2001 1 NONE PVT PVT Singulair; Zyrtec: Nasacort: Rynatan URI symptoms Allergic Rhinitis: RAD 1
0179262 12/19/2001 WV 1.5 1 .5 M 12/11/2001 Chicken pox like rash with low grade fever, cough, irritability-mild. Tow bacterial conjunctivitis treated with no smoking and opthalmic solution and Zithromax for bronchitis. Y Y 11/08/2001 11/29/2001 21 NONE PVT PVT NONE NONE Otitis Media 1
0179263 12/19/2001 PA 39.0 39 F 12/12/2001 Pain in right arm, up shoulders and into neck at 7 PM 12/11/2001. Y Y 12/11/2001 12/11/2001 0 NONE PUB PVT Cipro and Zithromax HIV positive AIDS 1
0179264 12/19/2001 PA 1.0 1 .0 M 12/06/2001 Present vesicles and papules on buttocks, inner thighs. Lesions lower legs some on pharynx. Y U 02/27/2001 12/06/2001 282 NONE PVT PVT NONE NONE NONE 1
0179265 12/19/2001 FL 5.0 5 M 12/11/2001 Mild erythema of left upper arm with swelling. Local warm compress and Motrin PRN. Y 12/10/2001 12/11/2001 1 NONE OTH OTH Nasal allergy Hypertonic adenoiditis had adnuidectomy 06/2001. 1
0179266 12/19/2001 MO 77.0 77 F 12/05/2001 Swelling of left arm mild redness. Y 12/03/2001 12/04/2001 1 NONE PVT PVT ASA, Effexor, Liptor NKA MO2001064 1
0179267 12/19/2001 F 12/12/2001 Hospital employee given influenza vaccine, then went home. Injection site became red, hot, raised (about 3 inches by 4 inches). Reported to infection control nurse on 12/12/2001. Still red and hot. 12/10/2001 12/10/2001 0 UNK UNK 1
0179268 12/20/2001 SD 53.0 53 F 07/10/2002 A phamacist reported that a 53 year old female received an injection of Flu Shield on 29-NOV-2001. Within one hour of vaccination, the pt developed paresthesia in her right foot which "traveled up her right side". She was hospitalized where an MRI showed transverse myelitis. No further information was available at the date of this report. The follow up states MRI of her spine showed a 1cm area of plaque at the T2 level. An MRI of the brain was normal. An analysis of her cerebrospinal fluid showed no abnormalities. A diagnosis of transverse myelitis was made. A visual evoked response potential test was normal. Somatosensory evoked potential of the posterior tibial area showed no reproducible cortical activity on the right. As of March 2002, the pt had "nearly complete resolution of symptoms"; however, she still complains of "occasional episodes of tingling in the leg." Y 2 U 11/29/2001 11/29/2001 0 MRI showed transverse myelitis-1cm plaque at T2 level; brain-normal OTH OTH Atenolo; Maxzide NONE Hypercholesterolaemia; hypertension NOS; rosacea HQ9443813DEC2001 1
0179269 12/20/2001 GA 0.8 M 12/19/2001 On 21-JUL-2000 the child received an injection of a Engerix-B. Subsequently, on an unspecified date he received an injection of a Recombivax-HB. In October 2001, the child's parent reported that he "started showing signs of autism" including not making eye contact, "several" unspecified developmental delays " a lot of" repetitive behavior and lack of speech. The parent reported that the child had been evaluated by a physician. Autism is considered medically serious. Y N 10/01/2001 OTH OTH medical history and concurrent medications were not specified. The child may be allergic to gluten 20010297481 1
0179270 12/20/2001 TX 3.0 M 12/19/2001 On an unspecified date, the child received an injection of Engerix-B; it was not known if the child had received previous injections of Engerix-B. The child also received injections of diphtheria and tetanus toxoids and acellular pertussis vaccine (see 20010297472), inactivated poliomyelitis virus vaccine, MMRII and Haemophilus influenza type b conjugate vaccine. Dates of immunization, and number of doses of each vaccine, were not provided. The child also received a tuberculosis purified protein derivative skin test on an unspecified date. The child's parent reported that, at 3.5 years of age, the child had a delay in the ability to speak and had a vocabulary of approx. 12 words. The child "was evaluated by the local school district, which stated that the child shows signs of autism and that can be caused by mercury poisoning". The parent reported that the child had not been evaluated by a physician. Possible autism and possible mercury poisoning in this report are considered to be "Other Important Medical Events". Y PVT PVT PPD skin test 20010297471 1
0179273 12/20/2001 TN 0.2 0 .2 F 12/19/2001 It is reported that a 2 mo old female would not respond to her mother following receipt of diptheria and tetanus toxoids and acellular pertussis vaccine absorbed (Infanrix). this report was rec'd from the infant's mother and has not been verified by a physician or other healthcare professional. On 12/10/01, the infant rec'd her 1st injection of Infanrix. on that date, she also rec'd injections of Haemophilus influenza type b conjugate vaccine (brand name unknown), inactivated poliomyelitis virus vaccine (IPOL) Aventis Pasteur), and 7-valent pneumococcal conjugate vaccine (Prevnar, Lederle labs). It was not known if she had rec'd previous injections of these vaccines. The parent reported that 1 hr post immunization the infant developed diarrhea., later that evening, an unspecified time post immunization she reportedly developed a fever of 104.7F and would not respond to her mother. The infant was hospitalized from 12/10 to 12/13/01. The parent reported that it was not determined what was wrong with her as of 12/13 the fever and diarrhea had resolved, but the infant still is not acting normal. The mother reported that the infant rec'd Infanrix lot DTPA522284A, however this is not a valid lot number. Y 4 U 12/10/2001 12/10/2001 0 PVT OTH 20010297491 1
0179281 12/20/2001 PA 1.75 1 .8 M 08/06/2002 Information has been received from a LPN concerning a 21 month old pediatric pt who on 9/28/01, at 11:00, was vaccinated SC, in her right thigh, with varicella virus vaccine live (lot 638491/1901K). At that time, the pt's temperature was 97.5F. On follow-up, it was reported that on 9/28/01, at 15:00, 4 hours, post vax, the pt developed a fever and excessive vomiting. The pt was taken to her physician's office for medical attention for her symptoms. At 15:43, the pt's temperature was 102.7F. The pt developed grunting (respiratory distress( because of her rapid rise in temperature. She was placed on a pulse oximeter which revealed an oxygen saturation of 87%. The pt was placed on oxygen therapy and sent to the ER via ambulance. After 1 hour of oxygen therapy, the pt recovered. Her oxygen saturation via pulse oximeter was 99%. Upon internal review, respiratory distress was considered to be an "Other Important Medical Event". In a few hours, after her arrival in the ER, the pt was sent home with a low-grade fever (99.0F to 100F) which lasted 2 days. Subsequently, the pt recovered from her symptoms. No further information was reported. Further follow up info was received from a physician. The child was evaluated on 10/26/01 for thrombocytosis. At the time of evaluation, he did not have any clinical symptoms. His physical exam and lab studies were within normal limits (HGS 12.7, WBC 7,700 and platelet count 359,000). It was documented that he was first noted to have an elevated platelet count "earlier this year," that elevated between 700 to 100,00 at times of viral infections or infectious processes and resolved when the infections subsided. He was diagnosed with reactive thrombocytosis. The physician indicated that the child would be followed on an "as needed" basis. Additional follow up inof revealed that the child had Pre-existing asthma. He was seen on 11/6/01 and it was reported that he seemed to have "done well with regard to asthma symptoms over the summer." It was reported that the physician thought the pt needed to use his nebulizer once. It was not known what the trigger was in that instance. On the whole, the child had not needed to use the nebulizer. It was noted that generally, he has more trouble during the child season. At the time of this evaluation, the child's chest was clear. The physician noted that varicella virus vaccine live "does not contain any egg proteins" and that if the child reacted to the vaccine, it might be attributed to another component, "possibly the gelatin." He further noted that he was not quite sure to what the child reacted. In addition, it was noted that the child had tolerated vaccination with MMR II without problems. No further info is available. Y Y 09/28/2001 09/28/2001 0 Allergy test for egg allergy-negative; HGS 12.7, WBC 7,700 and platelet count 359,000 OTH OTH NONE UNK WAES01100187 1
0179285 12/20/2001 79.0 F In 11/00, the pt was hospitalized due to leucocytoclastic vasculitis affecting skin and kidneys. Ovarian cancer was dx'd while in the hospital and the pt had a good response to chemotherapy (pallilative). The event resolved in 4/01 and the pt recovered. There was insufficient information to determine the reporter's causality assessment. Y Y 11/01/2000 11/01/2000 0 OTH OTH NONE PJP2001003080 1
0179286 12/20/2001 IN 1.09 1 .1 F 12/19/2001 The pt had a seizure on 12/18/01, 6 hours post vax. She was admitted to the hospital for observation and further testing. Neurologist to comment. Still in the hospital on 10/19/01. Per 1 year follow up: Pt did not recover. Pt continues with a seizure disorder. She is followed by neurologist on Phinobarb and Vulparic acid. Pt also see another MD at the hospital. Y U 12/18/2001 12/18/2001 0 MRI-no results yet PVT PVT Phenobarbital NONE Previous seizure history 04/03/2001~Pneumo (Prevnar)~2~0.00~Patient 1
0179287 12/20/2001 NY 1.0 1 .0 M 12/11/2001 This is a 1 year old male concerning a possible measles contraction from an MMR vaccine. He received IV Solu-Medrol while at ER and was on a po steroid taper, finished 10/15/01. He received an MMR vaccine and had a fever to 104F the 3 days, following vaccination. He was in his usual state of health until 11/9/01, when he developed a temperature of 102F. A macular rash was noted on his face 11/9/01, and by 11/10/01, had spread to his legs and trunk. He was treated with Benadryl and Tylenol as an outpatient but 11/12/01, was noted by his paternal grandmother to have increased irritability and decreased po intake along with photophobia. He was sent to the ER and transferred to the hospital. He had mild rhinitis and a cough consistent with his asthma that was nonproductive. No other known contacts regarding measles. The infectious disease dept was consulted and felt that serology would not help in the dx as IgM would be positive both after vaccination and with a wild-type exposure. The pt was observed overnight and remained stable and was discharged on 11/13/01, in the care of his guardian, his grandmother. He was to continue his Pulmicort bid and his albuterol prn and was instructed to call MD's office for a follow-up appointment. Y Y 2 Y 10/30/2001 11/10/2001 11 IgG; IgM-all wnl PVT OTH Pulmicort liquid BID; Xopnix q 6 hours, prn Asthma; chronic URI's 1
0179288 12/20/2001 NM 49.0 49 F 12/18/2001 12/17/2001 11:30 Rapid pulse, chills, shortness of breath, fatigue, malaise and fever of 104 .took ASA and slept. Y 12/07/2001 12/17/2001 10 N/A OTH UNK HTN Benadryl 1
0179289 12/20/2001 NJ 59.0 59 F 12/17/2001 11/13/2001 *:00 am-Awakened with a headache, took two Advil tablets 8:30 headache 3:00 pm received the Flu vaccine 3:30 pm took two Tylenol tablets 6:30 pm while changing clothes had red, very raised blotched areas from armpit and below, nipple line to neckline 7:00 pm took Benedryl 8:30 pm asleep to 11/14/2001 at 7:00 am, without rash. Y 11/13/2001 11/13/2001 0 PUB PVT Fosama None None 1
0179290 12/20/2001 MD 48.0 48 F 11/27/2001 Approx. 1 hours and 45 minutes, post vax, the pt experienced rapid heart beat, wheezing, congestion, heaviness in mid-chest. No history of asthma. The pt thought the room where symptoms occurred had a strong "moldy smell". The time course was 45 minutes then wheezing stopped, congestion gone and heaviness had diminished. She refused treatment. Y 11/06/2001 11/09/2001 3 NONE OTH OTH NONE NONE NONE 1
0179291 12/20/2001 WV 1.0 1 .0 F 12/14/2001 The pt received vaccines on 12/11/01 and post vax, her mother noted a red and warm area on her right thigh and called the office, She was instructed to apply compresses and give Tylenol. She called 24 hours later and came in for appointment. The right thigh was erythematous, indurated and warm (about 10cm X 8cm area). It was very swollen and erythematous (2cm X 2cm area at center of induration with a small scratch. No fever. She was started on Keflex X 7 days. 24 hours later, she had decreased erythema. No fever. Follow-up to be in 72 hours. The site of cellulitis is at Prevnar injection. Y Y 12/11/2001 12/12/2001 1 PUB PUB NONE NONE NONE 1
0179292 12/20/2001 AL 1.3 1 .3 F 12/13/2001 TaP given on 12/11/2001 in LT. On 12/13/01 a red area, measuring 9 cm X 5.5 cm and warm to the touch appeared at the injection site. Y 12/11/2001 12/13/2001 2 PUB PUB Tonsillitis None 1
0179293 12/20/2001 WA 0.2 0 .2 M 12/13/2001 The pt developed a rash around right leg vaccine site and on cheeks approx. 15 minutes, post vax. Y 12/12/2001 12/12/2001 0 PUB PUB NONE NONE 1
0179294 12/20/2001 IA 32.0 32 F The pt developed an onset of headache, photophobia and eyelid twitching about 5-6 hours, post vax. No history of similar symptoms. Y Y 11/20/2001 11/20/2001 0 CT of head-nml PUB PUB NONE IA01015 1
0179295 12/20/2001 CA 28.0 28 F 12/05/2001 The pt called the clinic on 12/9/01 to report abdominal cramping and with an urge to vomit (no emesis) several hours, post vax, of taking 1st dose (capsule) of oral Typhoid (on 12/3/01). This resolved spontaneously. (No rash or itching). It was taken on an empty stomach as per instructions. Y 11/20/2001 12/03/2001 13 OTH OTH chlorpheniramine maleate (antihistamine); BCP Allergic to amoxicillin; history of Sabanhoca ? 1
0179296 12/20/2001 AZ 0.3 0 .2 F 12/13/2001 After 1 full week, the pt had a fever of 99.8F max, lethargic (mom had to wake baby up to feed). Mom took her outside in the sun to wake baby up. Y 10/02/2001 PVT PVT 1
0179297 12/20/2001 NY 12.0 12 M 12/14/2001 11/30/2001-Rash on abnormal up to patient's neck 12/01/2001-Welts on patient's back Y Y 11/27/2001 11/30/2001 3 None PUB PUB None None None 1
0179298 12/20/2001 OH 39.0 39 F 12/17/2001 The pt's symptoms were observed at company health care on 11/30/01 on her left upper arm. There is a 7mm area of induration and redness centrally with 3cm redness and slight induration peripherally at the site of vaccine. No drainage, open lesions or lymphangitis. No systemic symptoms. Y 11/27/2001 11/30/2001 3 Temperature-98.8F; P-72; R-20; BP 140/82 PUB PUB 1
0179299 12/20/2001 MI 4.0 4 M 12/07/2001 On 12/5/01, the pt's right arm reddened. On 12/6/01, the entire upper arm was swollen, skin taut and reddened. He was taken to ER and given Keflex and Benadryl. On 12/7/01, the swelling was extended past his elbow. He denies pain. Child is active. Y Y 12/04/2001 12/06/2001 2 NONE PUB PUB NONE NONE NONE MI2001098 1
0179300 12/20/2001 MI 37.0 37 F 11/19/2001 The vaccine was administred at 2:45. In one hour, patient experienced pain in that arm; numbness at injection site and down to her finger tips. There was no discoloration. she couldn't move her fingertips for two hours. Two hours after the injection, her nose felt swollen, though this symptom couldn't be visually verified. She states that it was difficult for her to pass air through her nostrils. Patient saw urgent care. 11/15/2001 3:30 pm states reaction to Hep. B vaccine. 11/16/2001 Patient saw her M.D., who prescribed steroid & antihistamine for treatment. Two hours after treatment-no change was noted. 11/14/2001 11/14/2001 0 None PUB PVT 25 mg water pills (Not sure of its name) None Allergic to pollen, dust, mold, cats MI2001096 1
0179301 12/20/2001 MI 67.0 67 F 11/09/2001 Client states has been feeling a "tightness" in her throat since 8am this morning & "an itchy rash on the under side of the left arm, the same area I got the shot in". Client was encouraged to follow up with her doctor immediately 11/13/2001-Client went to her doctor. He gave her Benadryl & a creme to lessen the urticaria Y Y 11/08/2001 11/09/2001 1 PUB PVT None MI2001099 1
0179302 12/20/2001 TX 38.0 38 F 12/07/2001 Tingling to the jaw, Later got muscular aches & pains, insomnia, restlessness, sensitivity to sounds. Next day she got swellings under the arms. 12/07/01 her s/s have eased but sill has heaviness in her legs. Y 12/04/2001 12/04/2001 0 PUB UNK None None known TX01179 1
0179303 12/20/2001 CA 18.0 18 F 10/30/2001 Neck muscles soreness one week after vaccine Headache,sore throat, runny nose nine days after vaccine. persistent headache eleven to twelve days after vaccine. U 10/18/2001 10/25/2001 7 OTH PVT None None 1
0179304 12/20/2001 HI 69.0 69 F 11/20/2001-Patient received a tetantus vaccine after a foot laceration had occurred. 12/07/2001-Patient is seen for a 7 cm area of swelling and rash at the injection site. Y 11/30/2001 PVT PVT Clariten Flovent foot laceration ASA, Penicillin, asthma, osteoporosis, sinusitis 1
0179305 12/20/2001 MO 6.0 6 M 12/13/2001 12/03/2001 Received Havrix Hep A vaccine. On 12/09/2001 developed diarrhea x2, 12/10/2001 Temp 101.8 and mother gave Motrin. Fifteen minutes after Motrin patient had two large hives, tightness of both thumbs and one foot and swelling of lips. Mom took patient to ER where he was given liquid Benadryl & told he had fluid behind ears". Mother reports she is allergic to Motrin. Y Y 12/03/2001 12/10/2001 7 Mother referred to private physician for advice on further Hep. A and allergics PUB PUB Motrin fluid behind ears 1
0179306 12/20/2001 OH 5.0 1 .1 F 12/11/2001 Child developed varicella 12/11/2001. Rash scattered on face, chest and back. More than sixty lesions present. Y Y 08/11/1997 12/11/2001 1583 N/A PVT PVT None No No 1
0179307 12/20/2001 SC 16.0 16 M 12/13/2001 Pt developed periorbital swelling, urticaria to face and neck, tightness in throat and wheezing. Given albuterol by nebulizer X 1; IM Solu-Medrol. Y Y 12/10/2001 12/10/2001 0 EKG-sinus tachycardia; CXR-nml; neck X-ray; Pulse Ox-98%; PVT OTH NONE NONE NONE 1
0179308 12/21/2001 0.2 F 12/20/2001 Information has been received from a health professional concerning an approx. 2 month old female who on 7/25/96 was vaccinated with hepatitis b vaccine recombinant (yeast) (lot 0375D). Concomitant vaccinations on 7/25/96 included diphtheria toxoid/pertussis vaccine/tetanus (lot 5F71109), poliovirus vaccine (Orimune) (lot 7078R) and Hib conjugate vaccine (lot 6M61051). On 7/25/96, the pt developed a high fever, bruised thighs and high-pitched crying. The reporter stated that her daughter has had recurring infection and fever ever since. The pt received a total of 4 doses of DTP. The last dose was administered in 11/97. The pt's mother refused the 5th dose and any and all vaccination since. In 6/98, the pt presented with signs and symptoms of leukemia, which had been ruled out. The pt was dx'd with hemolytic anemia, splenomegaly and platelet disorder, which she feels, based on her research are the results of receiving DTP vaccine. The pt is currently under the care of a physician. The pt's experiences were considered to be "Other Important Medical Events". Follow-up information indicated that the patient also experienced autoimmune disorder (no details provided). No further information is available. (OMIC) Y N 07/25/1996 07/25/1996 0 UNK UNK UNK UNK WAES0112USA01743 1
0179311 12/21/2001 OH 5.0 5 M 12/14/2001 Pt developed ITP within 10 days, post vax. Y 1 Y 10/05/2001 10/15/2001 10 Platelet count-6,000 PVT PVT Amoxil NONE 1
0179312 12/21/2001 KY 72.0 72 F 12/06/2001 The pt developed generalized rash which started at noon on 12/05/01. Flu shot given at 09:00 on 12/5/01. U 12/05/2001 12/05/2001 0 PUB PUB Lipitor; Claritin; Zoloft; nadolol Allergic to sulfa and other allergies. KY2001093 1
0179313 12/21/2001 FL 76.0 76 F 12/14/2001 The pt developed a severe local reaction. Entire upper arm edema, induration, heat, erythema and pain. Her husband had the identical reaction from the same vial. Also, she had a systemic fever X 24 hours. Y 12/04/2001 12/04/2001 0 NONE PVT PVT Fosamax; valium NONE Allergy to codeine and Demerol 1
0179314 12/21/2001 NY 47.0 47 M 12/14/2001 About 5 days, post vax, the pt developed neck pain radiating into his left scapula, left deltoid and left axilla. No symptoms in the days immediately following the administration of the vaccine. Still symptomatic. N 11/06/2001 11/11/2001 5 NONE OTH PVT Atenolol; Naproxen; Ecotrin; Vitamin B1; Multivitamins NONE History of CVA; history of MI; chronic cervical spine problems 1
0179315 12/21/2001 PA 46.0 46 F 12/14/2001 5 minutes, post vax, the pt developed a rash to her torso (front and back). Her BP was increased at 170/90 and pulse increased at 120. Her lungs were clear and she denied shortness of breath. No pharyngeal edema noted. Her vital signs returned to baseline after 15 minutes. Observed for 45 minutes. Y 12/13/2001 12/13/2001 0 PVT PVT Iodine allergy 1
0179316 12/21/2001 PA 49.0 49 F 12/16/2001 The pt developed a hot fever, throwing up and a headache. Her husband called the hospital. Y 11/07/2001 11/08/2001 1 NONE PUB PUB Advair NONE Asthma; allergy to penicillin, lint, dust and lima beans 1
0179317 12/21/2001 MA 52.0 62 F 12/14/2001 The pt developed "chills, headache and a fast heartbeat which started last night (12/13/01)". She still has a headache and chills and feel tired. "Fast heart beat is resolved. Called my family physician to report and then notified Employee Health." Y 12/13/2001 12/13/2001 0 PUB PVT NONE Pt had allergy shots 2 weeks prior to vaccination; Asthma; environmental allergies (oak, pine, maple, dust and mold) 1
0179318 12/21/2001 CO 78.0 78 M 10/26/2001 The pt developed a fever, chills, nausea and vomiting. Dx'd with labyrinthitis and rx'd meclizine and compazine. Y Y 10/23/2001 10/26/2001 3 CBC: WBC-8.3; S 82.6%; Bands 5%; Lymphs 4% PUB OTH NONE NONE 1
0179319 12/21/2001 TX 33.0 33 F 11/20/2001 The client attended a health clinic at a community center on 11/14/01 where she received a TD booster. She complained of swelling to the left arm, face and neck. She was seen be an RN at the office at 15:30. Her left arm had redness to the deltoid area of approx. 2" in diameter with moderate swelling. No swelling to face, neck or chest, as she had stated. Her arm was warm to touch. Advised her to apply warm and wet soaks. Y U 11/14/2001 11/15/2001 1 OTH PUB NONE NONE NONE TX01180 1
0179320 12/21/2001 GA 0.4 0 .4 F 12/13/2001 The pt received vaccines on 12/4/01 and on 12/6/01, her parent witnessed a 30 second long episode of shaking of her entire body. This resolved spontaneously. The pt was afebrile. Dx: probable seizure. Y Y 12/04/2001 12/06/2001 2 Neurology evaluation and EEG. We offered a CT Scan and parent declined this evaluation. PVT PVT NONE NONE 1
0179321 12/21/2001 NJ 0.2 0 .2 F 12/17/2001 The pt developed rash, hives, edema to bilateral hands and feet and a temperature of 101.8F (R). The pt went to ER at approx. 23:00. Y Y 12/13/2001 12/13/2001 0 Blood and Urine culture PVT PVT NONE NONE NONE Unspecified reaction~Vaccine not specified (no brand name)~1~0.00~In Patient 1
0179322 12/21/2001 NY 1.08 1 .2 F 12/19/2001 On 12/10/01, the pt developed a fever with max of 102F on 12/10, 12/11, 12/12/ and 12/13/01. She had a rash consistent with varicella on my exam on 12/12/01. The rash resolved by 12/14/01. No crusting. Y Y 12/01/2001 12/10/2001 9 NONE PVT PVT NONE NONE NONE 1
0179323 12/21/2001 OH 0.5 0 .5 M 12/15/2001 The pt had screaming and 2 seizures. The 1st one lasted about 1 minutes and the 2nd one lasted 2-3 minutes. He was treated with Tylenol q 4 hours. This could be a reaction to pertussis. Y 11/26/2001 11/26/2001 0 NONE PVT PVT Zantac syrup; Miralax Constipation Seizure disorder; hypertonia 1
0179324 12/21/2001 CA 0.3 0 .3 M 12/12/2001 The pt developed a fine, red rash over his face, scalp, back, chest, abdomen at bilateral upper extremities. No involvement of lower extremities. No fever or diarrhea. No cold symptoms. Y N 11/30/2001 12/02/2001 2 PUB OTH Tylenol NONE NONE 1
0179325 12/21/2001 NY 1.5 1 .5 F The pt's mother called to state that the child's arm was swollen from shot site to elbow. That call came in on 12/12/01. The RN called family on 12/14/01, to see how the child was doing and the mother stated there was much more swelling. Mother was advised to give child Tylenol and put a cold compress on shot site. Y 12/11/2001 12/12/2001 1 PUB PUB Amoxicillin Ear infection NONE 1
0179326 12/21/2001 M 02/14/2003 The vaccinee did not have gout, psoriasis, Crohn's disease, or history of Lyme disease. There was no family history of rheumatoid arthritis or lupus. The vaccinee received an injection of Lymerix approx. 1 year ago; exact date of immunization and number of previous Lymerix injections was unknown. The reporter stated that the vaccinee began to experience joint pain "recently". IThe joint complaints were evaluated by a physician. No swollen or warm joints were noted on physical examination. Joint fluid was not obtained. The vaccinee was treated with naproxen (Naprosyn) 500 mg twice daily orally from 12/18/01 to 1/4/02 and with celecoxib (Celebrex) 200 mg twice daily orally from 1/4/02. As of 1/4/02, the outcome of the event was unknown. It was not known if he had sought medical treatment. No further information was available at the date of this report. The adverse event "joint pain" does not meet serious criteria but is being submitted as an expedited report by special FDA request per the 6/28/00 letter. Y U UNK OTH OTH The vaccinee did not have gout, psoriasis, Crohn's disease, or history of Lyme disease. There was no family history of rheumatoid arthritis or lupus. A0356409A 1
0179327 12/21/2001 FL M 12/15/2001 Shingles after Varivax. No history of exposure to active disease. Y Y None PVT UNK Unknown Duplication of ureters on left 1
0179328 12/21/2001 UT 1.0 1 .1 M 12/14/2001 child broke out with chicken pox on approx. 12/13/2001. Verified by nurse on 12/14/01 U 12/08/1997 12/13/2001 1466 PVT UNK UNK None chronic Sinusitis 1
0179329 12/21/2001 MI 1.25 1 .3 M 12/14/2001 Nine days after receiving MMR vaccine, the pt's temperature went up. When he was seen in the evening, a "generalized febrile seizure" was noted. Y Y 12/04/2001 12/13/2001 9 CBC-WNL chem 7 WNL PVT PUB None None None 1
0179330 12/21/2001 NJ 4.0 4 M 12/10/2001 Hypersensitivity reaction to immunization resulting in cellulitis swollen right arm for two days with itchiness and occasional pain pt. denies fever & restriction of movement. Y Y 12/04/2001 12/05/2001 1 None PVT PUB None no illnesses None 1
0179331 12/21/2001 CA 4.0 4 F 12/12/2001 Four days after receiving DTaP #4 and MMR #2, this pt. developed cellulistis on her right upper arm. she was given a ten day course of Keflex. Y U 12/09/2001 12/10/2001 1 PVT PUB None None None 1
0179332 12/21/2001 IA 1.9 1 .9 M 12/14/2001 DTaP, IPV,MMR given on 12/1/2001. On 12/14/2001, pt's right thigh was red, warm, swollen and afebrile. He saw a doctor who prescribed Benadryl and repeat appointment. Y Y 12/12/2001 12/13/2001 1 PUB PUB NA NA 1
0179333 12/21/2001 FL 78.0 78 M 12/14/2001 systemic fever, rigor, severe local reaction with edema, heat, pain, induration of entire upper arm, wife got identical reaction from same vial. Y 12/04/2001 12/04/2001 0 None PVT PVT cardizem.claritin None HTN, nephrolithiasis 1
0179334 12/21/2001 WA 5.0 1 .1 F 12/20/2001 Herpes Zoster (Unilateral band of red papules, painful, dermatomaz approximately T11) onset 12/18/2001. Culture obtained 12/19/2001, started on Acyclovir. Y U 11/03/1997 12/18/2001 1506 Viral (Herpes) Culture on 12/19/2001 PVT PUB Induced at 36 weeks ) Birth Weight 6Lbs, 15 oz Hospitalized for RSV Recent OM 1
0179335 12/21/2001 KY 10.75 10 M 12/14/2001 12/11/2001-client received vaccine at school. Very tense within ten minutes. Started to leave the room, looked back and then fainted. Revised, leg elevated for five minutes. then client was assisted to a chair. School LPN took client to cafe. Where he told her he had not eaten that morning. Client return to (his home)room when the RN felt that he was alright. Mother didn't feed him. 12/12/2001-client was at school without complaints. Y 12/11/2001 12/11/2001 0 N/A PUB PUB N/A N/A KY2001092 1
0179336 12/21/2001 KY 10.0 10 M 12/14/2001 12/12/2001-client's mother called health center. She stated that the client had broken out in "hives" vaccine had been administered on 12/11/2001. Doctor called mother and instructed to give Benadryl. Mother states that the doctor feels like the medicine (Cephalosporin) which the child was taking at time of the vaccination was the cause of the rash. 12/13/2001-Child was without any symptoms Y 12/11/2001 12/11/2001 0 N/A PUB PUB Cephlosporin KY2001091 1
0179339 12/26/2001 OH 31.0 F 12/17/2001 Information has been received from an RN concerning a 31 year old female who on 4/14/01 was vaccinated with the 2nd dose of varicella virus vaccine live. Her 1st vaccination was in 10/00. Subsequently, the pt reported that she had become pregnant shortly following the 2nd dose of varicella virus vaccine live. Follow-up information was received from an RN who reported that the pt has been lost to follow-up but that shortly after she received the vaccine she indicated that she was pregnant but never returned a positive pregnancy test. Subsequently, the pt indicated that she "lost the baby" and that she did not feel it was from the vaccine. Follow-up information was received from an RN who reported that she has doubts about the validity of the report of pregnancy from this pt/employee. She stated that the employee had "issues", that despite repeated requests, the employee would not bring in proof of a positive pregnancy test or a doctor's examination. The pt is no longer employed at the facility. Due to the uncertainty of the report, the pt will be dis-enrolled from the pregnancy registry and the pregnancy will be considered unconfirmed. No further information is available. N 04/14/2001 UNK UNK UNK Pregnancy (LMP-unknown) WAES01052254 1
0179347 12/26/2001 MI 81.0 81 F 12/17/2001 Information has been received from a RN and a physician concerning an 81 year old female who was vaccinated on 04-DEC-2001 with a second dose of pneumococcal vaccine 23 polyvalent. The pt was vaccinated with the first dose of an unspecified pneumococcal vaccine about 15 years ago without incident. The second dose was given on 04-DEC-2001 at 13:20 in the office. About 12 hours later, the pt had to be seen by paramedics, but not taken to the ER due to a rash across the abdomen, bradycardia, severe itching of the hands and face, SOB and passing out. The pt was treated per "anaphylactic reaction protocol" including epinephrine and Medrol. On 05-DEC-2001 per a phone interview between the pt and the physician, the pt was fatigued but stable and "clearly turning around" with the itching resolving. Upon internal reviwe, the pt's anaphylactic reaction was considered an other medical event. Additional information has been requested. Additional information was received from the registered nurse. The patient was vaccinated with an influenza vaccine (manufacturer unknown) approximately 10 days prior to vaccination with pneumococcal vaccine 23 polyvalent. It was reported that the patient received pneumococcal vaccine 23 polyvalent in the left arm. The patient subsequently recovered from the anaphylactic reaction. Upon internal review, the patient's anaphylactic reaction was considered an other medical event. No additional information is expected. Y Y 12/04/2001 12/05/2001 1 UNK UNK Aspirin, Liptor, Hydrodiuril, potassium chloride and vitamins Carotid bruit; glaucoma; hypercholesterolemia; hypertension WAES01120540 1
0179354 12/26/2001 PA 0.08 0 .1 M 12/19/2001 The grandmother of a 1 month old male reported that the infant received injections of Prevnar (1st dose), Hib-Titer (1st dose), DTP, poliomyelitis vaccine and Hep-B vaccine on 12/10/01. At approx. 21:00 on 12/10/01, that the pt's apnea machine alarmed, his lips "turned blue" and his body was "very" pale. His arms and legs were noted to be "jerking" and he stopped breathing. Cardiopulmonary resuscitation was performed and he was revived. He was than transported to a hospital. He reportedly has a nasogastric tube in place and has "sleep, central and obstructed apnea". Y U 12/10/2001 12/10/2001 0 UNK OTH OTH Caffeine Citrate UNK Apnea HQ9441613DEC2001 1
0179355 12/26/2001 MA 3.0 M 12/18/2001 A physician reported that a 4 year old male received a 1st dose of Prevnar (pneumococcal 7-valent conjugate vaccine) vaccine on 12/11/00, when he was 3 years old. On 11/5/01, he was admitted to the hospital to rule out appendicitis. On 11/6/01, he went to the OR for presumed perforated appendicitis but his appendix was normal. He was found to have "a lot of pus" in his abdomen. A swab was sent for culture. Lab data revealed a negative culture. The child was subsequently given a dx of nephrotic syndrome. No additional information was available as of the date of this report. Y Y U 12/11/2000 11/05/2001 329 Laboratory data revealed a negative culture. OTH OTH UNK NONE UNK HQ9413712DEC2001 1
0179357 12/26/2001 PA 26.0 26 M 12/18/2001 It was reported that a 26 year old male pt received a dose of Fluzone SV '01-'02 on 12/6/01 at noon. The dose was given in his right deltoid. The pt has been previously immunized with influenza vaccine once prior (2 years ago). At approx. 21:00, on 12/6/01, he began to feel numbness in his face and he could not shut his eye and had difficulty moving his facial muscles on one side. The pt was evaluated by an MD on 12/7/01. No dx as of yet. The pt now has slurred speech and is planning to see another physician for a second opinion. Y U 12/06/2001 12/06/2001 0 UNK UNK U2001012640 1
0179358 12/26/2001 11.0 11 M 12/11/2001 On 13-NOV-2001, the pt received a Fluvirin injection IM on the left deltoid muscle. On the morning of the next day, the pt experienced an asthma attack on 15-NOV-2001. The reporter provided no information on the inpatient therapy regimen. The pt was discharged from hospital on 19-NOV-2001 and has recovered. The reporter assessed the relationship of study medication to the event as possible. Also stated event may have contributed to by the pt's medical history. Y 4 Y 11/13/2001 11/14/2001 1 UNK UNK Unknown (oral) asthma medication Asthma PJP2001004670 1
0179360 12/26/2001 OR 0.2 0 .2 F 12/10/2001 Admitted to Med Center 10/12/2001 with temp 101 at home, runny nose, congestion, cough, vomiting, no diarrhea. Diagnosed with febrile illness. Y 2 Y 10/09/2001 12/12/2001 64 CXR- clear/wnl; Blood and CSF cultures negative; 11.1 WBC PUB PUB NONE NONE NONE OR200153 1
0179361 12/26/2001 CT 37.0 37 M 12/13/2001 The pt developed severe auto-immune arthritis with chronic pain. Y N 04/23/1999 05/23/1999 30 Genetic test of blood PVT PVT None 1
0179362 12/26/2001 CA 49.0 49 F 12/18/2001 Pt received flu vaccine on 12/14/2001. Now with erythema and blistering 1.5 cm by 1.5 cm at injection site. Y 12/14/2001 12/16/2001 2 NONE PVT PVT NONE NONE Allergy to sulfa causes rash 1
0179363 12/26/2001 NY 51.0 51 M 12/17/2001 Several days post injection bilateral hip aches down legs, getting better. N 12/06/2001 12/08/2001 2 OTH PVT NONE NONE NONE 1
0179364 12/26/2001 SC 58.0 58 F 12/17/2001 After injection, approximately 6 hours, left deltoid began hurting, then turned red and swollen at site, raised 1/4", not hard, centered, it stayed about 18 hours. Client did not apply ice or any treatment, thereafter it went away without difficulty. Y 11/26/2001 11/26/2001 0 NONE PUB PUB Premarin NONE NONE 1
0179365 12/26/2001 CA 54.0 54 F 12/13/2001 Parasthesias left arm post flu shot. U 11/15/2001 11/17/2001 2 PVT PVT NONE NONE 1
0179366 12/26/2001 MD 34.0 34 M 11/02/2001 Sore arm and throat, feverish feeling 30-45 minutes after immunizations. Temperature 100 F. No cough, no dysnea, no paresthesias and no pint swelling. Y 11/01/2001 11/01/2001 0 UNK UNK NONE NONE 1
0179367 12/26/2001 GA 62.0 62 M 12/14/2001 Patient complained of redness and swelling at site extending to elbow. Patient received injection in right arm. Pt stated he can hardly bend his arm and it is painful. Symptoms began the same evening of receiving the injection. Instructed pt when he reported symptoms on 12/14/2001 to apply warm compresses to arm and take Tylenol or Motrin for pain. U 12/12/2001 12/12/2001 0 MIL MIL 1
0179368 12/26/2001 MA 50.0 50 F 12/07/2001 Vaccine administered 11/19/2001. Symptoms began 11/20/2001; achy, feeling of "coming down with something." Head cold symptoms for 2 days, weakness and pain in all four extremities for 7 days, frequent, spontaneous sweats; minor sore throat and difficulty breathing. Sweats, SOB still present on 12/07. U 11/19/2001 11/20/2001 1 CXR-positive; PFT-negative PVT PVT NONE NONE PCN, Sulfa and back surgery three times 1
0179369 12/26/2001 NC 71.0 71 M Fever 102, nausea, swollen arm/shoulder for 3 days, chills and shoulder/arm sore for 3 days. Y Y 10/25/2001 10/25/2001 0 PUB PUB NONE NONE NONE 1
0179370 12/26/2001 NH 45.0 45 M 12/21/2001 At 1:30 PM pt was weak and feverish. At 2:30 PM pt took Tylenol and went to sleep. Did not take temperature. At 5 PM felt fine. Y 11/20/2001 11/20/2001 0 NONE PUB PUB NONE NONE NONE NH0126 1
0179371 12/26/2001 MN 1.25 1 .1 F 12/15/2001 VZV given 09/24/2001. Shingles rash develop early December 2001. Seen 12/07/2001. U 09/24/2001 12/07/2001 74 PVT PVT NONE NONE NONE 1
0179372 12/26/2001 MS 1.8 1 .8 M Urticaria began on leg opposite to injection site. No wheezing. Treatment: Beandryl. Y 12/07/2001 12/07/2001 0 NONE PVT PUB NONE NONE NONE 1
0179373 12/26/2001 VA 1.25 1 .3 F 12/17/2001 Fever up to 104 12/14/2001 to present. Redness at site (3/4" diameter ring around it) right thigh. Redness gone 3 days later. Clear runny nose and cough. Moaned and cried sine immunization given; tired. Advised to give Advil 3 times a day for 3 days and report any streaking. APAP, too. Increase fluids. Y N 12/13/2001 12/13/2001 0 PVT PVT Mild URI; Temperature 100 F. 1
0179374 12/26/2001 MN 35.0 35 M 12/21/2001 Three to four inch wide by three to four inch long redness, itchy area. Noted 2 weeks after injection and lasted 2 days. Used cortizone cream, went away. Y 11/30/2001 12/14/2001 14 NONE PVT PVT Synthroid, Ferrous sulfate 325 mg TID, B12 injection q mo. NONE Hypothyroidism 1
0179375 12/26/2001 MO 0.4 0 .0 M 12/11/2001 A few hours post vaccine child became irritable and developed lacy edematous rash to forehead. Y 12/11/2001 12/11/2001 0 NONE PVT PVT NONE NONE NONE 1
0179376 12/26/2001 MD 24.0 24 F 12/12/2001 The pt developed redness and tenderness surrounding the vaccinia (primary rxn) vaccination site with lymphangitis spread to the axilla. Treated with 5 days of Levaquin 500mg/day. Y 09/07/2001 09/17/2001 10 NONE PVT PVT Atrovent; Albuterol; Claritin NONE Asthma (stable); sulfa allergy 1
0179377 12/26/2001 MD 20.0 20 F 12/12/2001 The pt developed a tender, red, swollen and warm area around the site of the vaccinia vaccination; treated with Levaquin 500mg day X 5 days. Y 10/15/2001 10/23/2001 8 NONE PVT PVT NONE NONE Allergy to Ceclor 1
0179378 12/26/2001 MD 47.0 47 M 12/12/2001 The pt developed a 2cm tender, red and warm area around the site of the vaccinia vaccination; treated with Augmentin 875mg BID X 5 days. Y 11/14/2001 11/22/2001 8 NONE PVT PVT NONE NONE NONE 1
0179379 12/26/2001 MD 27.0 27 M 12/12/2001 The pt developed pain, localized swelling and redness at the site of primary reaction to the vaccinia vaccine with lymphangitis that spread to axilla; treated with 5 days of Tequin 400mg/day. Y 11/29/2001 12/07/2001 8 NONE PVT PVT NONE NONE NONE 1
0179380 12/26/2001 MD 29.0 29 F 12/12/2001 The pt developed a swollen, tender and red area around the site of the injection radiating to the elbow; treated with Augmentin 875mg BID X 10 days. Y 03/02/2001 03/11/2001 9 NONE PVT PVT Synthroid; Loestaid; Prozac NONE History of Graves Disease; S/P total thyroidectomy; Depression; Codeine intolerance 1
0179381 12/26/2001 DC 22.0 22 F 12/12/2001 The pt developed red, tender and swelling (primary rxn) around the site of the vaccinia vaccination with lymphangitis; treated with Tequen 400mg X 5 days. Y 04/03/2001 04/12/2001 9 NONE PVT PVT Ortho-Cyclen NONE Allergy to amoxicillin and latex 1
0179382 12/26/2001 MD 35.0 35 M 12/12/2001 The pt developed a 4cm area of warm, tender, red and swelling around the site of the vaccinia vaccine. It was treated with Levaquin 500mg X 5 days. Y 04/03/2001 04/12/2001 9 NONE PVT PVT NONE NONE NONE 1
0179383 12/26/2001 VA 26.0 26 F 12/12/2001 The pt developed a 6cm red, warm and tender area around the site of the vaccinia vaccination; treated with 5 days of Levaquin 500mg. Y 05/14/2001 05/23/2001 9 NONE PVT PVT Orthonovum NONE NONE 1
0179384 12/26/2001 DC 22.0 24 M 12/12/2001 The pt developed tenderness and redness on a 2cm area around the site of the vaccinia vaccination with lymphangitis distally; treated with Levaquin 500mg a day X 5 days. Y 06/11/2001 06/21/2001 10 NONE PVT PVT Flonase NONE Allergic rhinitis 1
0179385 12/26/2001 MD 30.0 30 F 12/12/2001 The pt developed a 2" area of tenderness that was red and swollen around the site of the vaccinia vaccination; treated with Cipro 500mg BID X 5 days. Y 06/18/2001 06/27/2001 9 NONE PVT PVT Depo-Provera NONE NONE 1
0179386 12/26/2001 MD 22.0 22 M 12/12/2001 The pt developed localized tenderness and redness over the site of vaccinia vaccination with lymphangitis to axilla; treated with 5 days of Augmentin, 875mg BID. Y 08/10/2001 08/20/2001 10 NONE PVT PVT PPD/Aventis-Pasteur/C0832AA/ID NONE NONE 1
0179387 12/26/2001 MD 22.0 22 M 12/12/2001 The pt developed a red, swollen, tender and warm area over the site of vaccinia vaccination with drainage from primary site and 1 1/2cm tender left arm in the left axilla; treated with Ceftin 250mg BID X 5 days. Y 01/16/2001 01/24/2001 8 NONE PVT PVT NONE NONE NONE 1
0179388 12/26/2001 MD 29.0 29 M 12/12/2001 The pt developed a 4cm red, swollen and tender area around the site of vaccinia vaccination with lymphangitis to axilla; treated with Tequin 400mg X 7 days. Y 01/19/2001 01/27/2001 8 NONE PVT PVT NONE NONE NONE 1
0179389 12/26/2001 MD 27.0 27 M 12/12/2001 The pt developed a 3" warm, red, tender and swollen area over the site of vaccinia vaccination. Treated with Ceftin 250mg BID X 5 days. Y 03/02/2001 03/13/2001 11 NONE PVT PVT NONE NONE NONE 1
0179390 12/26/2001 GA 30.0 30 M 11/28/2001 A 30 year old male with a history of 2 or 3 smallpox immunizations during childhood and "no takes" was vaccinated on 11/5/01 (signed in to clinic at 08:45, 19th pt of the day). Past medical history remarkable for 2 previous episodes of cellulitis following fairly minor skin trauma. On day 2, post vax, he developed a fever (99.0F-102.7F per vaccine adverse event card) which persisted until day 12. Also noted malaise, headache and chills. Nurse's note on day 5 describes above, plus "vaccinoid" response. Employee phoned clinic on 11/15/01 complaining of flu-like illness and temperature to 103.7F in the past 24 hours. When seen at the clinic that afternoon, he was noted to have a temperature of 100.6F and tachycardia. A 1.5cm scab c/w primary vaccine response was noted, with 8cm X 10cm area of surrounding erythema and induration. No drainage or lymphangitic streaking were noted. Site was unroofed with sterile needle and small amount of serous drainage was collected on sterile swab (culturette). Bacterial culture showed no growth. Employee was treated for presumed cellulitis with Rocephin, 1gm IM, plus cephalexin 500mg BID. Upon recheck the following AM, pt was afebrile and tachycardic and induration at site had resolved without any change in area of redness. Contact on 11/17/01 and 11/18/01 by phone revealed no further report of fever and continued resolution of soreness and redness. Recheck on 11/19/01 revealed well-scabbed primary reaction without surrounding inflammation. Temperature was 98.2F and pulse was 68. No complaints since that time. Clinical dx: probable cellulitis plus vigorous primary response to vaccine. Y Y 11/05/2001 11/14/2001 9 Serous drainage culture-no growth; CBC-nml (WBC-9.6K, mild absolute monocytosis of 1046 cells/mcl with 10.9% monos, with otherwise normal diff OTH PUB Wellbutrin NONE 1
0179391 12/26/2001 GA 47.0 47 M 11/28/2001 A 47 year old male vaccinated on 11/5/01 (signed in to clinic at 08:40, 17th pt of the day). Recheck on 11/13/01 revealed 1.5cm scabbing pustule with 14cm surrounding erythema and tenderness of left axilla. The nurse noted 'obvious reaction to tape'. Recheck on 11/14/01 revealed same area of erythema, no fever. (No central clearing in area of gauze, as would be typical for simple tape reaction). Pt empirically started on cephalexin 500mg BID. Next day, erythema noted to be much improved and the pt stated that he was feeling better. On 11/20/01, sent e-mail stating "Rash is almost gone. No further problems". Clinical dx: possible cellulitis, r/o vigorous primary response to vaccine. Y Y 11/05/2001 11/13/2001 8 NONE OTH PUB Zyrtec; Nasonex NONE Allergies to Ampicillin and sulfa 1
0179392 12/26/2001 GA 44.0 44 M 11/28/2001 A 44 year old male vaccinated at 14:00 on 11/6/01 (do not know which vaccine vial used, but presumed to be same as 11/5). On 11/15/01 recheck revealed primary response along with 4cm area of redness extending down medial arm from vaccine site. Recheck on 11/16/01 revealed only faint redness of medial arm in area previously described, 5-6 erythematous "rays" noted extending from vaccine site in all quadrants. Pt was afebrile and site was not tender. Because of previous 3 cases of presumed cellulitis among 11/5/01 and 11/6/01 vaccinees, the pt was treated with cephalexin as a precaution. Recheck of site on 11/19/01 revealed afebrile pt with no real change in appearance of site. On 11/20/01, e-mail from pt stated that scab had fallen off, "all is looking fine" and no other problems. Clinical dx: probable lymphangitic response to vaccine, r/o early cellulitis. Y Y 11/06/2001 11/15/2001 9 NONE OTH OTH 1
0179393 12/26/2001 GA 50.0 50 F 11/28/2001 A 50 year old female vaccinated at 14:15 on 10/29/01, using reconstituted that morning with preservative-free diluent (vaccine lot 4008284, diluent lot 040601). On 11/15/01 recheck revealed primary response with crusting scab and 3cm surrounding induration. Redness noted in areas in contact with tape and pt was switched to paper tape for dressing changes. On 11/6/01 recheck revealed 3" (about 7.5cm) redness and induration surrounding vaccine site. Fullness of axilla on the same side as vaccine site was noted without palpable node. The pt was empirically begun on Augmentin, 250mg TID and redness and induration noted to be "mostly gone" by the nurse who rechecked pt on 11/9/01. Clinical dx: 'possible secondary infection of vaccine site, vs late reaction to vaccine components'. Y Y 10/29/2001 11/04/2001 6 CBC-revealed WBC-3.9K with 41% neutrophils, 41% lymphocytes, 5.4% eosinophils, 0.3% basophils and 9.6% monocytes. OTH PUB NONE NONE Faint, nausea and diaphoresis about 4 hours, post vax~Typhoid Vi Polysaccharide (no brand name)~1~22.00~In Patient 1
0179394 12/26/2001 GA 47.0 47 M 11/28/2001 A 47 year old male was vaccinated at 10:45 on 11/6/01. On 11/13/01 recheck, noted to be c/w primary response. On 11/15/01 recheck because of "increased redness, swelling and tenderness of site that revealed 1.5cm primary response with 3" X 4" surrounding erythema and induration with sharply defined borders. Temperature noted to be 99.1F. Pt empirically begun on cephalexin 500mg BID. Recheck on 11/16/01 revealed a temperature of 97.8F and 1.5cm scab surrounded by 1.25-1.5cm of induration with faint erythematous border. Border was not sharply defined at this point. On 11/19/01 recheck, reveal "trace scattered induration at margin of primary response" with "very faint scattered erythema mostly distal to primary response site". Clinical dx: probable cellulitis, r/o vigorous primary response to vaccine. Y Y 11/06/2001 11/15/2001 9 NONE OTH PUB NONE NONE Allergy to penicillin 1
0179395 12/26/2001 VA 1.25 1 .2 M 12/17/2001 12/11/01, healthy, immunizations given. 12/12/01, red raised and tender area at the site of right thigh of 4cm in diameter. 12/13/01, temperature 102.9F (ax) at night. 12/14/01, redness gone, temperature 103.6F (ax), increasing cough, watery eyes and runny nose. 12/15/01, seen in office and was given Advil, fluids and observed. 12/17/01, watery eyes, runny nose, temperature 99.2F (ax) and decreased cough. Taking fluids well. Y N 12/11/2001 12/12/2001 1 PVT PVT Luride gtts 1
0179396 12/26/2001 NJ 1.7 1 .6 M 12/15/2001 2 hours, post vax, the pt developed 3 episodes of clonic movement of the right arm and right leg X 15 seconds with 5 minute spacing between episodes. No loss of consciousness. He seemed normal 20 minutes later. Exam done within 24 hours. No focal deficits. Neurologist's exam was normal. Y Y 11/30/2001 11/30/2001 0 EEG-nml PVT PVT NONE NONE NONE ~DTaP (no brand name)~1~0.20~In Sibling 1
0179397 12/26/2001 NY 1.25 1 .3 M 12/18/2001 The pt developed hives, erythema and itching within 30 minutes of receiving MMR. He was given Benadryl 12.5mg and symptoms improved. Y Y 12/18/2001 12/18/2001 0 NONE PVT PUB NONE Runny nose Had hemorrhage with circumcision 1
0179398 12/26/2001 MO 48.0 48 F 12/11/2001 The pt states that she developed chills and fever and her left arm and lymph nodes under her left arm became very sore and aching as well as into back, approx. 12 hours post vax. She had a light facial rash, 24 hours post vax, that faded quickly. No reaction at the injection site. Y 12/10/2001 12/10/2001 0 NONE PUB PUB Methotrexate; Pulmocort; Serevent; Premarin; Atenolol; Wellbutrin; Synthroid; Cyclotemax Asthma MO2001069 1
0179399 12/26/2001 NY 1.6 1 .5 M 12/12/2001 Left lateral thigh with 6" diameter erythemic, macular, swollen area and tender to touch. Treated with Atarax, Motrin and compresses. U 12/05/2001 12/07/2001 2 PUB PUB URI/Obesity Obesity and right clavicle fracture 1
0179400 12/26/2001 NM 2.0 2 .1 M 12/17/2001 Within 20 minutes of vaccine administration, the pt had hives on neck, trunk, groin and thighs with a feeling of itching in mouth as well. He saw his provider within 60-90 minutes of 1st symptoms. He was given Zyrtec po. U 12/12/2001 12/12/2001 0 NONE PVT PUB Treated for OM, 2 weeks prior to vaccination 1
0179401 12/26/2001 AL 6.0 1 .2 M 12/04/2001 The pt developed varicella lesions on 12/4/01. Treatment on 12/6/01 with Zovirax 2 1/2 tsp qid X 5 days. Also had strep proctitis on 12/6/01. Atarax prescribed for itching. He will recover. Y U 11/12/1996 12/04/2001 1848 PVT PVT NONE NONE 1
0179402 12/26/2001 IL 77.0 77 F 12/18/2001 The area around the injection site was warm, indurated and erythematous (15cm X 13cm and 4cm X 3.5cm). Y 11/29/2001 12/06/2001 7 NONE PVT OTH OTC vitamins Superficial laceration NONE 1
0179403 12/26/2001 TX 42.0 42 F 12/13/2001 The pt developed a rash on her torso, arms and legs. She had the shot at approx. 14:30 and the rash and itching started approx. 20:00. Went to the doctor and said it could be related to sulfa antibiotic taken the previous week and was referred to an allergist. Y N 12/11/2001 12/11/2001 0 OTH PVT Prempro; Allegra; Bactrim-DS NONE Hayfever 1
0179404 12/26/2001 NJ 56.0 56 F 12/01/2001 The pt developed chills, muscle aches, headache, stomach pain and fever which started 18 hours, post vax, and lasted about 3 days. Then she had a lot of sweating. She relapsed on 11/26/01 and had similar symptoms with joint pain and weakening in muscles. Y N 11/19/2001 11/20/2001 1 PVT PVT Cozaar; zinc; Prilosec; Claritin; Celebrex; Flonase; Quinine sulfa; Xanax NONE High blood pressure; gastro-reflux; arthritis; nasal allergy; leg cramps 1
0179405 12/26/2001 MI 0.5 0 .5 M 12/12/2001 The pt developed a temperature of 103.4F and irritable. He had URI symptoms X 2 days. Y 12/10/2001 NONE PVT PUB NONE NONE 1
0179406 12/26/2001 MO 0.8 0 .9 F 11/27/2001 The pt was limp and had a temperature of 103F which started on 11/21/01. Mom says "there's chickenpox in our family right now too. I called the MD and the receptionist said to give her ibuprofen." Mom was advised by the RN to see her MD or go to ER. On 11/26/01, the mom stated "the child was seen in ER and given Benadryl. She ran a fever for 2 days, but is fine now". Y Y 11/19/2001 11/21/2001 2 NONE PUB PUB Tylenol; ibuprofen NONE NONE MO2001068 1
0179407 12/26/2001 MO 4.0 4 M 11/21/2001 The child's father reported a fine rash and white spots on his tongue and itching of skin rash. Y Y 11/14/2001 11/15/2001 1 PUB PUB MO2001067 1
0179408 12/26/2001 IN 1.3 1 .3 M 12/21/2001 The pt's face was red, he was very agitated, vomiting with hives on face and legs. He was given Epinephrine 1:1000, Benadryl 25mg q 6 hours X 48 hours and Advil 1 tsp po now and q 6 hours. Improvement was seen right away. Y 12/17/2001 12/17/2001 0 PVT PUB 1
0179409 12/26/2001 IN 2.0 1 .6 M 12/06/2001 The pt developed a rash (papular pustules), initially tender then itchy, only on 1 dermatome. Symptoms are only compatible with dx of shingles (Herpes Zoster) after varivax. Y 04/24/2001 12/04/2001 224 OTH OTH NONE NONE 1
0179410 12/26/2001 NE 0.3 0 .3 F 02/06/2001 Post vax, the pt couldn't sleep well and had a papular rash on her upper chest, neck and into her scalp. Y Y 10/09/2000 10/10/2000 1 OTH OTH Pediacare "Cold" 1
0179411 12/26/2001 NE 0.3 0 .3 M The pt developed a "fibrous tissue (lump) on anterior thigh, secondary to immunization. Received immunizations 1 month prior to ER visit. Y U 10/19/2000 11/19/2000 31 OTH OTH UNK Diaper rash 1
0179412 12/26/2001 FL 9.0 3 M The pt had 5-10 lesions and a low temperature X 1-2 days. Y 08/30/1995 12/05/2001 2289 PVT PVT NONE NONE NONE 1
0179413 12/26/2001 NE 0.2 0 .2 M 04/18/2001 The pt was fussy, vomiting, not eating well and crying. Y Y 11/30/2000 12/01/2000 1 OTH OTH NONE 1
0179414 12/26/2001 NE 0.5 0 .5 F 04/04/2001 The pt was fussy and irritable. Y Y 11/20/2000 11/20/2000 0 PVT OTH NONE 1
0179415 12/27/2001 MD F 12/21/2001 Information has been received from a physician concerning a female pt who on 01-SEP-2001 was vaccinated with varicella virus vaccine live. The physician reported the pt scheduled an OB appointment "because the pt believed that she was pregnant as she was apparently ovulating at the time she received the vaccination". No adverse experiences were reported. No further detail were provided. Follow up information provided indicated the date of the pt's last menstrual period was 20-AUG-2001 and the estimated date of delivery was 27-MAY-2002. The pt had a diagnostic ultrasound which showed and IUP of 8.5 weeks, no fetal motion and diagnosed as a missed abortion. The pregnancy outcome was a spontaneous abortion at 12 3/7 weeks from the pt's LMP. the pt did not have any illnesses, infections nor was she taking any prescription drugs. Additional information is not expected. Y U 09/01/2001 11/14/2001 74 Ultrasound-pregnancy UNK UNK Pregnancy (LMP-8/20/01) WAES01100286 1
0179416 12/27/2001 4.0 M 12/20/2001 Information has been received from a physician for a case in litigation concerning a 7 year old male who in approximately 1998 was vaccinated with MMR II, also referred to as the "triple measles vaccine" by the physician. The pt presented with a history of recent psychomotor retardation without any associated history or signs of an infectious or neoplastic process. Investigation concluded that the etiology lay in a subacute sclerosing panencephalitic process attributable to the MMR II. The pt manifested no allergies to egg protein and his immediate post vaccination course had been uneventful. There had been no evidence of measles prior to the vaccination and his psychomotor development had been normal until the onset of symptoms. Subsequently, in approximately August 2001 the pt died. Y N 01/01/1998 OTH OTH UNK UNK WAES0112USA01104 1
0179417 12/27/2001 PA 1.0 1 .0 M 04/02/2002 Information has been received from an RN concerning her 12 month old son with developmental delay, microcephaly (not cerebral palsy), seizure and cognitive disturbance (unable to communicate verbally) who in approx. 2/99, was vaccinated with varicella virus vaccine live. On approx. 11/21/01, the pt developed seizures which were worse than usual. On approx. 11/23/01, the child became cranky, crabby and miserable. His mother noted "mosquito-bite" like lesions in his diaper area. The mother called her physician who at that time did not consider the lesions to be chickenpox because blisters did not appear. The child was unable to sleep that night and the next day, the child developed blisters, some of which were "blistery". The blisters appeared on his left upper thigh and leg (approx. 10), trunk between the abdomen and chest (4 to 5), neck (2) and ear (1). The mother reported that she felt that the blisters were mild and she was able to count the lesions. The mother also reported that approx. 3-4 weeks prior to the appearance of the blisters, she received a letter indicating that someone in her child's school had developed chickenpox. Her son had not had direct contact with the person in question. The child was treated with acetaminophen (Tylenol) "around the clock" and did not develop a fever at any time. The child recovered from "his experience". The RN also reported that her other son developed chickenpox while on therapy with varicella virus vaccine live (WAES0112USA01812). Additional information has been requested. Follow up info from a physician indicated that the child "did not have any reaction to the vaccine." The report was only filed because in December 2001 the child developed varicella infection despite having had the vaccine. Upon internal review the seizures were considered an other important medical event (OMIC). The registered nurse also reported that her other son developed chickenpox after receiving varicella virus vaccine live (WAES0112USA01812). Y 02/28/1999 11/21/2001 997 Body tem-afebr PVT PVT UNK Cognitive disturbance; developmental delay; microencephaly; seizure ~Varicella (Varivax)~~4.00~In Sibling WAES0112USA01518 1
0179419 12/27/2001 NJ 11.0 11 F 12/21/2001 Information has been received from a RN concerning a 11 year old female with no past medical history and no known allergies who on 14-SEP-2001 was vaccinated with the first dose of Recombivax HB. The child received the adult formulation as a part of the adolescent dosing regimen. It was reported that one week following the vaccination the child developed a fever and chills. The child also experienced pain in her left wrist, knee and ankle and experienced chest pain. In addition, the child developed a rash which was described as urticaria. The child was seen by her pediatrician who performed blood work. The rheumatoid factor was negative. The child was referred to a rheumatologist and was diagnosed with rheumatoid arthritis. At the time of this report the rash persisted and was being treated with Benadryl. The child is also receiving prednisone and Celebrex. The outcome of the fever, chills, chest pain and rheumatoid arthritis is unknown. According to the nurse, the child's treating physician did not believe these events were the result of the Recombivax HB vaccine. Upon internal review, the event of rheumatoid arthritis was felt to be important for an other medical event. Additional information has been requested. The patient's father reported that on 09/16/01, his daughter had to stop playing basketball because she experienced pain in her wrist and knee. She developed a fever and chills and experienced pain in her neck, back and all of her joints. She was seen in an emergency room three time for the pain she was experiencing. Subsequently, the patient's joint pain persisted. In FOLLOW-UP, the patient's mother reported that the patient was still experiencing a rash (not previously reported), fever, joint pain, chills and insomnia (not previously reported). The mother further stated that the patient's physician felt that her daughter's symptoms were not related to the Hepatitis B vaccine recombinant (yeast) and he felt that it was possible for the patient to experience more than one side effect at a time. The mother stated that she felt that the patient's syndrome were too much of a "coincidence" not to be related to the Hepatitis B vaccine recombinant (yeast). FOLLOW-UP information has been received from a registered nurse. The nurse reported that the child received the adult formulation of the vaccine as part of the adolescent dosing regimen. It was reported that within one week following the vaccination the child developed a fever (temperature measurement not provided) and chills. The child also experienced pain in her wrists, elbow, knees and ankle, and experienced chest pain. In addition, the child developed a rash which was described as urticaria. The child was seen by her pediatrician who performed blood work. The rheumatoid factor was negative. The child was referred to a rheumatologist and was diagnosed with rheumatoid arthritis. At the time of this report, the rash persisted and was being treated with diphenhydramine (Benadryl). The child is also receiving Prednisone and Celecoxib (Celebrex), was reported to be doing better. According to the nurse, the child's treating physicians did not believe that these events were the result of the Hepatitis B vaccine recombinant (yeast). Upon internal review, the event of rheumatoid arthritis was felt to be important for an other medical event. Conflicting FOLLOW-UP revealed that the onset of the patient's fever, rash, and joint soreness was on 09/21/01. FOLLOW-UP information from a nurse practitioner indicated that the patient developed juvenile rheumatoid arthritis one month after receiving Hepatitis B vaccine recombinant (yeast). The family thinks the patient may have received MMR instead of Hepatitis B vaccine recombinant (yeast). Additional follow up information received from the nurse practitioner indicated that the patient was in her office's care for a chronic rheumatic disease and that her office didn't feel that the sutiation was a result of the immunization. they do not believe that the patient's disease was a result of an adverse event from the hepatitis B vaccine recombinant (yeast). For this reason, and the fact that they did not give the immunization originally, they have nothing to add to the case. Upon internal reveiw, the event of rheumatoid arthritis was felt to be import for an other medical evetn. Additional information has been requested. Additional information is not expected. (OMIC) A 15-day follow up report received 9/24/2003 adds no new info. Y N 09/14/2001 09/21/2001 7 Serum Rheumatoid factor-09/01/01 -negative PUB PUB UNK NONE WAES0112USA01635 1
0179420 12/27/2001 CO 44.0 44 F 12/21/2001 Information has been received from a physician concerning a 44 year old white female RN with depression, periorbital darkening, "hereditary" tremor, "bursitis" of the left knee and allergies to morphine, droperidol and butorphanol (Stadol) and a history of asthma "that occurred mostly during childhood", hysterectomy, oophorectomy and vaccination with an unspecified hepatitis vaccine, who on 8/24/01 was vaccinated with a 4th dose of Hep-B vaccine recombinant (yeast) in the left deltoid (lot 639853/0672L). The physician reported that the pt was a new employee to the hospital who indicated that she received an "unknown" hepatitis vaccine when it first came out approx. "10-15 years ago". The pt had antibody titers drawn which were "negative". She was then advised to received the Hep-B vaccine series. On 8/24/01, within 5-10 minutes of receiving the vaccine, she began experiencing multiple organ symptoms. On 8/24/01, the pt experienced general sense of warmth, sweating, pain and swelling at the site of injection, diaphoresis and numbness of the affected arm. She complained of difficulty swallowing but not of difficulty breathing. She felt dizzy and nauseous but did not vomit. She was treated with Benadryl and IV steroids in the ER. She had no respiratory symptoms. Most of her symptoms were subjective and not objective. She received a 1 week course of prednisone. On 8/27/01, the pt felt drowsy and fatigued like she was coming down with the flu and "felt mentally not connected". On 9/4/01, the pt developed diarrhea, vomited once, felt tired, felt like her "thyroid zone" was swollen and her throat felt scratchy. She became out of breath when climbing up stairs. The physician reported that the rheumatoid factor was elevated to 10 times the normal level. The pt was referred to a rheumatologist. On 10/4/01, the pt had a constant global headache and crampy abdominal pain with watery diarrhea. The pt was fatigued and dyspneic with a non-productive cough, watery nasal discharge and sore throat. The injection site was still tender and swollen but not red. The pt had general myalgias, arthralgias, sweating, neurasthenia and a poor appetite. The physician confirmed that the pt's symptoms went on for at least several weeks and she was out of work for a while. The pt had returned to work on "light duty". The physician reported that as of 12/6/01, the pt had no improvement on extended course of prednisone in high dose and she had not recovered. The physician felt her symptoms were not vaccine related. The pt's positive rheumatoid factor, abdominal pain, decreased appetite, headache, diarrhea, diaphoresis, dysphagia, increased erythrocyte sed rate, dyspnea, influenza-like disease, injection site reaction, decreased mental acuity, vomiting, swelling, nausea, neurosis and hypesthesia were disabling. No additional information is expected. Y Y N 08/24/2001 08/24/2001 0 Antibody titers-neg; erythrocyte sed rate-slightly elevated at 24 and on 10/3/01 a repeat sed rate was 4 and rheumatoid factor was 203 IU/mL (10 times the normal level); CBC-nml except mild increase in percentage of neutrophils; UA, metabolic profile, sed rate, c-reactive protein, antinuclear antibodies, anti-centromere and thyroid stimulation test were normal. OTH OTH Prozac; Prilosec; Mirapex; Prometrium Hysterectomy; asthma; oophorectomy; bursitis; periorbital disorder; tremor; morphine allergy; depression WAES01101998 1
0179421 12/27/2001 IN 64.0 M 12/21/2001 Information has been received from a male consumer who on 9/27/01 was vaccinated with pneumococcal vaccine 23 polyvalent (reported as 'ML 54440, Pasteur Merieux"). On 10/4/01, the pt experienced a severe headache followed by fever attacks reaching a temperature of 40.6C. The pt was seen by his family doctor who found "nothing since there were no obvious indications on the lung". The pt had no cold or any other influenza type symptoms. On 10/10/01, the pt was admitted to the local hospital where a chest x-ray revealed a "severe attack of pneumonia on the left part of the lung". There were no additional symptoms other than the high fever. The pt was treated with "a daily injection of liquid antibiotics" for a total of 10 days. He was hospitalized for a total of 5 days. The pt felt that the "sickness was introduced in (his) body from the injection of Pneumovax 23 on 9/27/01". Additional information has been requested. Follow up information from a physician indicated that the patient recovered on 10/15/01. Additionally, the physician considered a causal relationship with the vaccine as unlikely. Additional information from a physician's record noted that the patient was admitted to the hospital on 10/10/01 with one week old febrile infection, temperatures of up to 39 degrees C and headaches. On admisstion to the hospital, the patient was noted to be in good general condition and good nutritional state, conscious, awake and oriented in time and place, with no dyspnea, cyanosis, anemia, edema or jaundice. Skin and mucous membranes showed no signs of irritation. Lymph nodes were not palpably enlarged, pupils were of equal size. Heart and lung findings were unremarkable. Peripheral pulses were normal. Abdomen was soft, no defense or resistance and no tenderness. Peristalic sounds were present, liver and spleen not palpably enlarged, renal bed not painful to percussion. Rectal examination showed: rectal ampulla filled with soft brown feces, no resistance palpable. Gross examination of the skeletal and nervous systems were unremarkable. On admission, the patient had a temperature of 39.6C. X-rays showed extensive left-side infiltration, confirmed only by slightly increased inflammatory chemistry lab levels of CRP 8mg/dl. The patinet was placed on antibiotic therapy with ceftriaxone sodium and promptly became afebrile. On follow up the infiltrate was found to have receded. With prior insulin therapy, the patient's daily blood sugar profiles after defervescence were within the normal range. Laboratory results included: ESR 37/67 mm acc. to W; Leukocyte count 6100/mcL; erythrcyte count 4.06 mill/mcL; hemoglobin 12.2 g/dl; hematocrit 35.6%; MCV 88 mcm^3; platelets 259,000 mcL; differential leukocyte count (lymphocytes 6%, neutrophils 81%, basophils 1%, eosinophils 0%, monocytes 11%), CRP 8.7%; albumin 49.1%; alpha-globulins 6.7%; alpha2-globulins 14.7%; beta-globulins 9.6%l gamma-globulins 19.9%; glucose 216 mg/dl; GGT 50 U/L; alkaline phosphatase 181 U/L; cholinesterase 2215 U/L. The following values wre found to be within normal limits: total protein; bilirubin; uric acid; urea; creatinine; GOT; GPT; LDM; CK; CK-MB; cholinesterase; lipase; amylase; potassium; calcium; coagulation; TSH; Basal level; HbA1C 5.8%; urinary status. Aerobic and anaerobic blood cultures were negative. ECG showed sinus rhythm normal, normal heart position, heart rate 80/min and elevated wave in leads V2-V6. The chest x-ray showed extensive infiltrate in left lingula pulmonis area and a follow up chest x-ray showed regressive infiltrate. An abdominal ultrasound showed unremarkable findings. On 10/15/01, the patient terminated his stay in the hospital on his own responsibility against medical advise, afebrile and asymptomatic. Medication on discharge included ceftriaxone sodium, insulin, axubrochin, and protaphan. The patient's diet included 12 bread exchange units. No further information is available. Y Y 5 Y 09/27/2001 10/04/2001 7 Chest X-ray revealed "severe attack of pneumonia on the left part of the lung". Laboratory results included: ESR 37/67 mm acc. to W; Leukocyte count 6100/mcL; erythrcyte count 4.06 mill/mcL; hemoglobin 12.2 g/dl; hematocrit 35.6%; MCV 88 mcm^3; platelets 259,000 mcL; differential leukocyte count (lymphocytes 6%, neutrophils 81%, basophils 1%, eosinophils 0%, monocytes 11%), CRP 8.7%; albumin 49.1%; alpha-globulins 6.7%; alpha2-globulins 14.7%; beta-globulins 9.6%l gamma-globulins 19.9%; glucose 216 mg/dl; GGT 50 U/L; alkaline phosphatase 181 U/L; cholinesterase 2215 U/L. The following values wre found to be within normal limits: total protein; bilirubin; uric acid; urea; creatinine; GOT; GPT; LDM; CK; CK-MB; cholinesterase; lipase; amylase; potassium; calcium; coagulation; TSH; Basal level; HbA1C 5.8%; urinary status. Aerobic and anaerobic blood cultures were negative. ECG showed sinus rhythm normal, normal heart position, heart rate 80/min and elevated wave in leads V2-V6. OTH OTH Actrapid, Insulin Diabetes Type I WAES0112USA01985 1
0179422 12/27/2001 FL F 12/21/2001 Information has been received from a RN concerning a pt who on 03-DEC-2001 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. Subsequently, the pt was seen in the ER on 03-DEC-2001 because her left arm was swollen and she had some SOB. She was treated with Benadryl and an unspecified inhaler. On 05-DEC-2001, the pt was seen in the office and was diagnosed with cellulitis. She was admitted to the hospital on 05-DEC-2001. The pt was treated with IV antibiotics and was discharged on 08-DEC-2001 with PO antibiotics. The pt's outcome was unknown. The RN was concerned and would like to obtain a lot check. No further information is expected. Y Y Y 12/03/2001 12/03/2001 0 OTH OTH UNK UNK WAES01120796 1
0179423 12/27/2001 LA 2.0 M 06/17/2002 Information has been received regarding a case in litigation which concerns a male child who during the time frame of March 1993 and September 1994 was vaccinated with several vaccination which contained the mercury laden preservative thimersol. It is alleged that the pt received a dose of MMR II. The pt allegedly suffers from the effects of mercury poisoning. Upon internal review, suffers from the effects of mercury poisoning was determined to be an other important medical event. No further information is available. It is alleged that the pt also received a dose of Haemophilus B conjugate vaccine and a dose of hep B vaccine. In addition, it is also alleged that the patient has been exposed and continues to be exposed to highly toxic emisission from power production facilities within the environmental zone of his residence. It is stated that these emission have contributed to the patient's total dose of poisonous mercury by inhalation and ingestion. In addtion to mercury, the emissions are known to contain nickel chromium and other heavy metals. Upon internal reveiw, the toxic neurological effects of mercury poisoning were determined to be other important medical events. No further information is available. (OMIC) The follow up states that a psychological evaluation was received as follow up info. The evaluation was performed on 3/7/95, 3/13/95 and 4/19/95. The pt's age at the time of the evaluation was two years and three months. The pt lived at home with his parrents and older brother. His mother worked part-time and spent much of the day with him. the pt was taking no prescribed medications at the time of evaluation, but he did regularly take an antihistamine for fluid in his ears. At the time of the evaluation the pt had recently had his heairng checked. There was no apparent hearing loss, but there was a difficulty with fluid build-up in his ears. The pt's mother expressed concern regarding his limited use of and regression in language and his unusual behaviors such as muscle rigidity and hand flapping. The pt also failed to follow his pt's directives. The parents watned to know the extent to which these behaviors could be controlled and if they could be improved. Per the parents, the pt was the product of a full term pregnancy. The umbilical cord was positioned around his head during delivery, but there was no need for administration of oxygen. The pt's birth weight was eight pounds. The pt's infancy was described as playful, irritable, alert, active and fussy with frequent crying. Some developmental delays were noted by the pt's family, such as the fact that he didn't say his first words until the age of 18 months, however, it was noted that as he reached 24 months he stopped saying these words and regressed to only vocalizing vowel sound.s The pt's sitting and walking were delayed also. The pt was previously evaluated in Feb 1995 and developmental delays were noted. At the time of the report, the pt was utilizing both speech and occupational therapies. He exhibited delays in social interaction in that he would rarely show interest in engagin in play with other children. Interactions with his brother usually were parallel play. The pt was often aloof with others, but would show affection spontaneoulsy with his mother. No significant life changes or stressors were reported as having occurred within the family since the pt's birth. The behavioral assessment included both a parent interview and direct observation sessions. Assessment tools included the vneland adaptive behavior scales: survey form, the autism behavior checklist, the child behavior checklist, the Ritvo-Freeman real life rating scale, the childhoold autism rating scale and the Rayley scales of infant development. The vineland adaptive behavior scales were administered in standard semi-structured interview format to the pt's mother. The vineland measures adaptive functioning in the areas of communication, daily living skills, socialization and motor skills. It also yields an overall measure of adaptive functioning, the adaptive behavior composite. The pt's scores in the communication domain put him at a one year one month age level. His scores in the daily living skills domain put him at a one year eight month level. His scores on the socialization domain put him at the one year zero month level. His scores in the motor skills domain put him at the two year seven month level. The pt's relative strength in motor skills was further qualified by his mother's report that she perceived his gretest strength to be his gross motor abilities. The ABC was administered to the pt's mother. The ABC is a 57 item behavioral checklist. A total score of 67 or higher is considered indicative of autism. The pt's score was significantly lower than the cutoff score, indicating that the mother rpeorted that he is not exhibiting many of the behaviors that are indictive of autistic symptomatology. The CBCL is a broad spectrum behavior rating scale desinged to assess social compstence and behavior problems in everyday environments. Per the info provided by the pt's mother, he scored above the 98th centile ont he wihtdrawn subscale. In addition other behavioral problems were endorsed such as being easily frustrated, defiant, upset by new people or situations and chewing inedibles. The RLRS is a behavioral rating scale completed by a trained observer based on a 30 minute observation of the child's behavior. The RLRS was completed by one examiner based on the pt's observed behavior at the psychological services center. Behaviors rated as occurring repeatedly during the observation period included repetitive vocalization, repetitive stereotypic behavior, hand flapping, ignoring interaction attempts, self-isolation, watching objects in motion and noncommunicative vocalizations. The pt's overall score suggested the presence of a few pathognomic autistic symptoms. The CARS is a behavioral rating scale used for diagnosing autism. The CARS was completed by one examiner based on observations made in the clinical and the home environment. The CARS provides a measure of the degree or prresence of autistic sympotoms. The pt's total score indicated the presence of symptoms of moderately autistic behavior. He exhibited difficulties in inappropriate body and object use, imitation, listening response and nonverbal and verbal communication. The Bayley scales of infant development consists of three scales: the mental scale, the motor scale and the behavior rating scale. It was difficult to maintain the pt's attention on the test and he needed frequent shifting of items in order ot cooperate with testing. He frequently did not respond to initial verbal prompting to engage in the task at hand, and he often required repeated prompting. On both the mental and motor scales, the pt displayed mildly delayed performances. His performance on the behavior rating scale was non-optional in areas of emotional regulation and motor quality. His orientationand engagement was in the questionable optimal range when compared with an age-normed sample. The pt was observed at home and in the clinical setting. Two home visits were conducted and behaviros observed included hand flapping, especially when new stimuli were presented, parallel play with brother, repetitive vocalizaiton of vowel sounds and inappropriate use of objects. He also displayed inappropriate use of objects by mouthing on toys, coins, etc. Review of the DSM-IV criteria and theh current psychological results indicated htat the pt displayed several pathognomic features of autistic disorder. The testing results; however, were varied in the identification of significant signs of autism. The identified symptoms may be better accounted for by "pervasive developmental disorder not otherwise specified." A treatment play was included wiht the purpose of increasing eye contact; increasing the amount of time spent attending to a task or being spoken to by others; increasing the number of vocalizations he uses to communicate his wants and needs. Chronic fluid in ears is considered to be an incidental finding. Upon internal review, the toxic neurolgoical efffects of mercury poisoning and pervasive developmental disorder were determined to be other important medical events (OMIC). No further info is available. N 01/01/1995 OTH OTH UNK WAES0112USA01575 1
0179425 12/27/2001 NY 57.0 57 F 12/17/2001 Severe knee pain in December 2000, given Vioxx. Wrist pain, hip pain, shoulder pain to date. Per 1 year follow up: Pt did not recover. Osteoarthritis (knees, back, and hip) Y Y N 04/19/2000 12/20/2000 245 X-rays revealed beginning osteoarthritis PVT UNK Prempro, Atenolol Allergy; hypertension; fibromyalgia osteoarthritis~Lyme (LYMErix)~3~58.00~In Patient 1
0179426 12/27/2001 CA 56.0 56 M 12/18/2001 Developed cellulitis left upper extremity 1 day following Pneumovax. No organism identified. Pt treated with Clindamycin, Zocin. Pt is asplenic from trauma. Y 3 Y 12/14/2001 12/15/2001 1 NONE PVT PVT Zocor NONE Aplenia: Hyperlipidemia 1
0179427 12/27/2001 TN 1.3 1 .4 M 12/03/2001 The pt's mother states that she called the doctor on 11/28/01 to report concerns of redness and swelling in right arm and received instructions to apply warm heat and to call back with any problems. The signs and symptoms increased and the child was taken to see an MD at 14:00 on 11/28/01 with increased swelling and redness. He was dx'd with infection at the vaccine site. He was rx'd with antibiotics (1st dose given at 16:00). Mom took child to ER at 22:00. She states the swelling had spread to his shoulder, chest and neck. He was admitted to the hospital X 2 days and dx'd with cellulitis of the right upper extremity. Phone call on 12/3/01 to mom states the child had a fever of 101.8F-102.8F on 12/2/01. PMD is aware. Temperature on 12/3/01 was 99F. Y Y 2 Y 11/27/2001 11/28/2001 1 NONE PUB PUB NONE CBC-43 segs and 41 lymphs; WBC-19.9 NONE TN01063 1
0179428 12/27/2001 FL 66.0 66 F 12/06/2001 The pts were administered the flu vaccine and the pneumococcal vaccine after obtaining informed consent, between 08:30-09:00. Later that day, the ER physician called stating that 2 pts were being admitted into the hospital with hypoglycemia. It was reported that both pts blood sugars were in the 40's with signs and symptoms of hypoglycemia. The ER/hospital progress notes were unavailable at the time of this report. There was no history of diabetes in either pt. Y Y U 12/06/2001 12/06/2001 0 Blood sugars-in the 40's OTH OTH 1
0179429 12/27/2001 WA 21.0 21 M 12/17/2001 Fatigue and sexual dysfunction. Fatigue started in January,2001, sexual problems also. N 11/18/1999 01/01/2000 44 Rheumatoid factor-68 (H) MIL MIL 1
0179430 12/27/2001 MD 26.0 24 M severe hair loss, numbness in legs/muscle/ joint pains, constant chest pains; severe headaches, "knots" on head; eye sensitivity; sores in mouth, sick with "flu" more often than usual; blood in stool; itchy skins, rashes, difficulty concentrating, memory loss; chronic fatigue; severe mood swings arthritis in fingers, fungal growth on neck. N 03/06/2000 MIL MIL NONE NONE Asthma 1
0179431 12/27/2001 MD 26.0 26 F 12/18/2001 Received Smallpox vaccine on 12/07/2001. On 12/14/2001, Read 12/14/2001 positive lymphadenopathy. Returned 12/18/2001, increase in size of pustules, extreme axillary tenderness, red straking from site to ant. axillary area. Levaquin 500mg 1 po qd #5 Y 12/07/2001 12/16/2001 9 N/A PVT PVT None No No 1
0179432 12/27/2001 MD 22.0 2 .9 F 12/14/2001 Smallpox vaccine given 12/05/2001. Checked in office day 7. Adverse reaction on days 8-9, increased swelling, increase erthema approx. 2-5 inches in diameter. Fever 102 , no lymph, no streaking. treated with Levaquin 500 mg 1 po qd #5 Y 12/05/2001 12/13/2001 8 N/A PVT PVT None no no 1
0179433 12/27/2001 MD 25.0 25 F 12/17/2001 Pt. returned on day 7 with reddened swollen arm, pain axillary lymphadenpathy, fever 102, Limited rom arm.Deltoid area, warm to touch, malaise, Treated with Levaquin 500 mg 1 po qd #5 Y 12/07/2001 12/14/2001 7 N/A PVT PVT None no no 1
0179434 12/27/2001 WI 45.0 45 M 12/17/2001 Bell's Palsy -12/03/2001-date of onset. Y N 11/05/2001 12/03/2001 28 PUB PVT none UNK 1
0179435 12/27/2001 MA F 12/14/2001 pain and stiffness in the area where the shot was given Y 12/14/2001 12/14/2001 0 P 72 BP 160/80 R 121 ROM intact no numbness in fingers PUB PUB buffered ASA None None 1
0179436 12/27/2001 DC 66.0 66 F 11/07/2001 Pt with 2 month history of intermittent shaking chills on multiple meds status post liver transplant 6 years ago. Ten minutes after shot developed lightheadedness, shaking chills similar to prior episodes associated with moderate hypotension and bradycardia, supine position, observation, self-medication with valium, resolved in one hour. Y 11/07/2001 11/07/2001 0 MIL UNK NONE Six years post liver transplant 1
0179437 12/27/2001 NY 11.0 11 M 12/20/2001 half hour after receiving vaccine, the patient complained of their right thumb and index finger tingly. patient is right handed. Examined 11/21/2001. positive Tinel's sign, positive FH of Carpel Tunnel. Plays hockey and shoots left handed. also does a little computer work. Y U 11/01/2001 11/01/2001 0 EMG=R median neuropathy carpel tunnel syndrome PVT PVT albuterol lactase deficiency 1
0179438 12/27/2001 CA U Right arm swelled in evening 2 times normal, fever. Went to bed. Late 2nd day felt normal. It moved from arm inside chest to back and up. 11/08/2001 3 PM Local drug store had flu and pneumonia vaccines. Y 11/08/2001 11/08/2001 0 OTH PUB NONE NONE NONE swelling~Pneumo (no brand name)~1~77.00~In Patient 1
0179439 12/27/2001 OR 42.0 42 F 12/16/2001 Pain immediately upon injection. Severe tenderness, achy pain, swelling from shoulder to elbow within 2 hours. By 3 hours, unable to lift arm. Severe nausea difficulty breathing. Arm red, feverish to fingers. As of 12/16/2001, persistent joint pain/ache, but swelling better. U 12/12/2001 12/12/2001 0 OTH PVT Alesse 28; Singulair; Zyrtd; Effexor NONE Inhalitory(aspegillis, phenol, rodent dander), Food (beef and mango). 1
0179440 12/27/2001 VA 59.0 59 F 12/21/2001 On 10/29/2001 at 10:30 AM administered vaccine (flu). By 10:55 AM pt became sick to stomach, weak, diarrhea, no vomiting. By 11 AM weak, warm, diaphoretic, quite pink all over. Unable to hear BP. No respiratory distress, no hives, no localized reaction at site. Poorly responsive. Sent to ER via ambulance. Y N 11/29/2001 11/29/2001 0 Atrial fibrillation labs and Halter monitor. OTH OTH NONE Stomach Virus NONE 1
0179441 12/27/2001 MN 42.0 42 M 12/14/2001 Temp spikes to 103.5 for 24 hours. Sweats, myalgias and malaise. 12/13/2001 12/13/2001 0 WBC 8,100 PVT PVT NONE No allergies, right seapular winging, atospermia, impotence, pipe smoker 1
0179442 12/27/2001 CA 74.0 74 M 12/18/2001 Day one joint pain, sore throat, hard to breathe. Day two congestion and fever. Day three headache and cough. Symptoms continued for 20 days. Y 12/06/2001 12/07/2001 1 NONE PVT PVT NONE Hay fever, morphine, tape, demerol and has gout. 1
0179443 12/27/2001 MI 79.0 78 M 12/17/2001 Pt was seen by eye doctor 3 days after receiving flu shot with complaint of blurry vision. Eye doctor diagnosed pt with a swollen optic nerve. Pt treated with steroids. Y 10/26/2001 10/29/2001 3 MRI negative for any cause for swollen optic nerve. PUB PUB NONE NONE 1
0179444 12/27/2001 AL 44.0 44 F 12/19/2001 Ten minutes after the Flu shot, I had sever pain in my entire left arm. The next morning, I had swollen lymph nodes and a lot of swelling in my neck. Left side pain continued for 5-7 days. Swelling 6 weeks. Still swelling in neck. Y N 10/30/2001 10/30/2001 0 PVT OTH NONE Codeine, Bactrium, Erytmomicin, Fibromyalgia 1
0179445 12/27/2001 IN 23.0 23 F 12/19/2001 Redness local irritation soreness at site. Onset at 3:05 PM. Gave pt cold pack to applyat site for local soreness. Informed pt to notify physician. Y 12/19/2001 12/19/2001 0 OTH UNK 1
0179446 12/27/2001 IN 32.0 32 M 12/19/2001 Pt presented with rash present on neck and anterior chest at approximately 3:55 PM. Called MD. Physician instructed to give pt the chleranin tablets in Epi kit. At 4 PM save pt tabs to take. Explained to pt that it was antihistamine could present drowsiness. Call if respiratory problems occur. Y 12/19/2001 12/19/2001 0 NONE OTH UNK NONE PCN 1
0179447 12/27/2001 WV 45.0 45 F 11/30/2001 Two hours after site became red, hot, swollen and itching. Hives developed on left arm and chest. She had URI 2 weeks prior. Has chronic smokers cough. Wheezing returned after flu shot. Advised her to see her physician, use cold packs, ibuprofen for pain, hydrocortisone for itching. By 11/29/2001 had 5 inch indurated area, had not called or seen doctor. Y Y 11/26/2001 11/26/2001 0 NONE PUB PUB Calritin D URI Allergic to codeine, emycin, Benadryl, Robitussin, PPD, wools, strawberries/ Syncope 1
0179448 12/27/2001 CA 64.0 64 F 12/11/2001 Pt called 12/10/2001 in the morning stated after few hours of flu shot pt was very sick over the weekend like hoarseness voice, fever, moderately wheezing on her lungs, coughing and body weakness for three days. Pt stated never felt like thi before with previous flu shot. Pt stated felt very sick until today 12/20/2001. 12/07/2001 12/07/2001 0 PUB PUB NONE NONE CA010137 1
0179449 12/27/2001 MI 47.0 47 M 12/18/2001 12/08/2001 Left deltoid swollen and sore. Left ear and left side of neck swollen, painful and reddened. red, raised rash on left, neck and into hair, still apparent on 12/11/2001. No swelling on deltoid area or shoulder. Afebrile. Referred to physician. Y U 12/07/2001 12/08/2001 1 PUB PUB NONE NONE NONE MI2001101 1
0179450 12/27/2001 WI 0.2 0 .2 M 12/21/2001 Per child's mother (Gillian Ritscher), the event lasted fifteen-twenty sec. Arms flew over head, face become bright red, some body shaking and stiffening. Eyes watered and some drooling from mouth. No fever. Y 12/19/2001 12/21/2001 2 None PVT PVT tylenol none-well child slight outward tilt of right ear-cartilage felt in ear. 1
0179451 12/27/2001 GA 1.25 1 .3 M 12/20/2001 Patient complained of exaggerated local reaction vs. cellulitis noted within 48 hours at shot site . Also a fever, which went as high as 102 and increased fussiness. Patient was treated with oral reflex and motrin. Y 12/18/2001 12/18/2001 0 N/A MIL MIL 0 sprained ankle GERD/larmgmmalcia 1
0179452 12/27/2001 CA 1.3 1 .3 M red, swollen & itchy 12/12/2001 12/13/2001 1 none PVT PVT none none 1
0179453 12/27/2001 OH 0.4 0 .4 M 12/17/2001 norexia-refused bottles for twenty-four to forty-eight. Y 12/13/2001 12/13/2001 0 Phys. exam only PVT UNK Rondee DM Infant Drop PRN N/A, mild nasal cogestipion N/A yes~DTaP (no brand name)~~0.00~In Patient 1
0179454 12/27/2001 AZ 0.6 0 .6 F 12/18/2001 rash, erthematious papulars Y 11/15/2001 11/16/2001 1 None PVT OTH none no none 1
0179455 12/27/2001 GA 1.0 1 .0 F 12/18/2001 high fever of 104 Y Y 12/11/2001 12/15/2001 4 PVT PUB none 1
0179456 12/27/2001 MI 0.9 0 1 M 12/19/2001 12/18/2001-took child to E. R. He had lumps/redness @injection site then lumps/bumps to his chest (Hives) per Mother. E. R. instructed to give Benadryl as directed on package. Also to watch for s/s resp. distress and return to E. R. prn. Y Y 12/13/2001 12/18/2001 5 PUB UNK none None 1
0179457 12/27/2001 CA 0.3 0 .3 F 12/20/2001 Given first dose of Prevnar on 12/11/2001. Had two episodes of tremors with eyes rolling back for a few minutes on the forth and fifth day after receiving the Prevnar. Y Y 12/11/2001 12/15/2001 4 Nerology referral PVT PVT None URI seven days later None 1
0179458 12/27/2001 KS 1.0 1 .0 F 12/18/2001 12/07/01 shots, 12/14/01 rash fever, 12/15/01 diarrhea, rash in mouth & allo over body. Fever 101-fine pinpoint rash Mom got gastrointestinal flu 12/15/01 12/07/2001 12/14/2001 7 None PUB PUB HNB (healthy new born) 1
0179459 12/27/2001 WI 4.0 4 M 12/31/2001 12/19/2001 Vaccine Adminstered 12/20/2001 Mom noticed while bathing the patient, areddish/purple area- 5-6" x2-3' around the injection site on his left arm. no fever or tenderness. 12/21/2001 Mom reports reaction U 12/19/2001 12/20/2001 1 none PVT PVT none none 1
0179460 12/27/2001 IL 0.5 0 .5 M 12/19/2001 bulging fontanelle 48 hours after receiving DTaP and Prevnar Y Y 09/25/2001 09/27/2001 2 CT head-n LP-N CBC-N PUB OTH typical hydrocortisone eczema, ear drainage for three days gastroschisis, premature 1
0179461 12/27/2001 TN 2.0 2 .5 M 12/20/2001 Left thigh with 23 cm X 14 cm area of redness, warth induration, 3 large bullae and numerous surrounding vesicles. Y U 12/18/2001 12/19/2001 1 PVT PUB Tussi-12 U.R.I 1
0179462 12/27/2001 VA 0.3 0 .3 M 12/20/2001 The pt developed a screaming episode that lasted 3 hours. Y 12/20/2001 12/20/2001 0 PVT PVT NONE 1
0179463 12/27/2001 CA 1.08 1 .1 F 12/14/2001 A physical exam was done on 12/11/01. The child was healthy. About 2 hours, post vax, the pt began with fever, fussiness, poor appetite and was less active. Maximum temperature was 103.8F. Still having fever today and was given Tylenol. Temperature decreased to 101.7F in the clinic today. No signs of infection on exam today. No local reactions on legs. Treated with Rocephin, IM, 500mg. Y U 12/11/2001 12/11/2001 0 Stat CBC; Blood culture; UA and Urine culture done today OTH PUB PPD NONE Hemangioma (back) 1
0179464 12/27/2001 NY 0.5 0 .5 M 10/29/2001 The pt developed a total body jerking for 2-3 minutes followed by a staring spell for about 1 minute. The baby then was lethargic/sleepy for about 1 hours. He was taken to ER after the event with a temperature of 99.1F. No antipyretics were given. Y Y 10/23/2001 10/25/2001 2 EEG scheduled for 12/6/01 and the results were nml PVT PUB NONE NONE NONE 1
0179465 12/27/2001 NY 0.6 0 .6 F 12/19/2001 The pt developed a rash and fever X 1 wk. In the past at 2 and 4 months, the pt had the same prolonged rash X 2 weeks at the site of vaccination. Every vaccine caused a rash that lasted 2 weeks. Y 11/27/2001 11/27/2001 0 NONE PVT PVT NONE NONE NONE 1
0179466 12/27/2001 ME 2.0 2 .2 M 12/12/2001 The pt's left arm became hot with edema over injection site. Y 11/26/2001 11/28/2001 2 NONE PVT OTH NONE 1
0179467 12/27/2001 NY 1.0 1 .1 U Ten days, post vax, the pt developed a notable generalized red measles rash with fever. Febrile seizure X 1. Y Y 12/06/2001 12/16/2001 10 PVT PUB NONE NONE NONE 1
0179468 12/27/2001 SC 1.25 1 .3 F 12/17/2001 The pt presented on 12/15/01 with a temperature of 103F (rectal). No source of temperature. Dx'd with viral illness vs reaction to immunizations. Y Y 12/14/2001 12/15/2001 1 PVT OTH NONE NONE 1
0179469 12/27/2001 NJ 1.3 1 .3 F 12/20/2001 A rash appeared on 12/18/01 and also possible conjunctivitis as per pt's mother. Rash seems to be spreading. On 12/19/01, the pt presented to office with generalized varicella lesions, red in each eye and a red pharynx at the time of the exam. Y U 05/03/1996 12/18/2001 2055 Rapid strept-positive PVT PVT NONE NONE NONE 1
0179470 12/27/2001 OR 0.3 1 .4 F 12/19/2001 The pt developed a red lump on left leg bigger than mom's fist. Had inconsolable crying on 12/17 and was given ibuprofen. On 12/19/01, she guards to walk. Is recovering. U 12/17/2001 12/17/2001 0 PUB PUB 1
0179471 12/27/2001 CA 0.3 0 .4 F 12/17/2001 This pt's 2 month vaccinations resulted in about 4 days of unusual twitching and irritability. Her 4 month immunizations given individually. The DTAP caused "batting at air, like on speed". She had less slept for the next 24 hours. Happy throughout the reaction. Afebril. Resolved after about 24 hours. Y 12/04/2001 12/04/2001 0 NONE PVT PVT NONE NONE NONE 1
0179472 12/27/2001 NV 3.0 3 F 12/21/2001 The pt developed a high fever to 105.5F, the evening following immunization. Seen at MD's office the next day, still febrile that morning temperature of 103F. Lab work ordered. Y Y 12/13/2001 12/13/2001 0 CBC; UA; Blood culture-all WNL PVT PVT NONE NONE NONE 1
0179473 12/27/2001 WI 44.0 44 F 12/21/2001 The pt's left shoulder (deltoid) had redness, swelling, tenderness and induration in an area 4cm X 5cm in diameter. U 12/19/2001 12/21/2001 2 NONE PVT OTH Allergy to Dolobid 1
0179474 12/27/2001 WI 5.0 5 M 12/21/2001 On 12/19/01 at 13:30 the pt received vaccines. On 12/20/01, left arm was sore. On 12/21/01, AM, mom noticed a 3" X 4" area that was red, warm, swollen and hard on his left upper arm. Y 12/19/2001 12/21/2001 2 PVT PVT NONE Cold; pharyngitis NONE ~Hib (no brand name)~4~1.00~In Sibling|~DTaP (no brand name)~2~0.30~In Sibling 1
0179475 12/27/2001 NY 4.0 4 M 12/20/2001 The pt developed swelling at the site of the injection, including elbow and shoulder. No pain or redness in left arm. Y 12/18/2001 12/20/2001 2 PVT OTH NONE NONE 1
0179476 12/27/2001 LA 43.0 43 F 11/07/2001 The pt broke out in measles-type rash on 10/26/01. Y Y 10/12/2001 10/26/2001 14 NONE PUB PUB NONE NONE Down's Syndrome 1
0179477 12/27/2001 OH 1.25 1 .3 M 12/13/2001 The child presented for DTAP which was given without incident. The mother phoned me on 12/12/01 to state the the pt's leg swelled to double in size, became red and hot to touch. The mother states she took the pt to MD who examined the child, gave IM Rocephin and place child on oral Augmentin. The doctor told the foster mother that the child should not receive any more pertussis vaccine. I phoned the doctor and spoke with the doctor's nurse who stated that the doctor treated the pt for a cellulitis of the leg. I inquired if the doctor felt this was from technique and she stated "no, it was from the vaccine". I phoned the foster mother to see how the pt was doing today and she stated he was much better today, that the swelling was diminished and the redness and the hot to the touch, was better. Y Y 12/10/2001 12/10/2001 0 NONE PUB PUB NONE NONE NONE OH0073 1
0179478 12/27/2001 MA 6.0 3 F 12/19/2001 The pt received the chickenpox vaccine (Varivax) on 1/11/99. She was dx'd with chickenpox rash on 12/19/01. U 01/11/1999 12/19/2001 1073 NONE PVT OTH NONE NONE 1
0179479 12/27/2001 OH 0.3 0 .4 F 12/20/2001 Significant (extensive) erythema and edema at injection site on right thigh, covering the middle third anterolateral and medial aspects. The reaction was immediate (within 5 minutes). Y 12/19/2001 12/19/2001 0 NONE PVT PVT Nystatin for diaper rash Diaper rash NONE 1
0179480 12/27/2001 IN 1.0 1 .0 F 12/18/2001 The pt received MMR on 12/10/01 (SC) and on 12/18/01, the pt reported to office with a maculopapular, non-vesicular rash to entire trunk, extremities, face and scalp areas. On 12/18/01, the pt apparently was feverish at home. In the office on 12/18/01, the pt exhibited malaise and irritability. Mother reports the pt is "feeling better today". N 12/10/2001 12/16/2001 6 NONE PVT PUB NONE Otitis Media 12/8/01 NONE 1
0179481 12/27/2001 IL 4.0 4 M 12/15/2001 The pt developed an area approx. 4.5cm X 3/5cm of induration and erythema with very slight pain at the right thigh site which occurred at 48 hours, post vax. Treated with cold pack and clinical monitoring. The pt's parents applied a warm towel. In the morning, as erythema had spread, the pt was brought to the clinic. No other symptoms. Came to clinic on 12/15/01. Patient's induration/erythema resolved when called patient back on 12/19/2001. Y U 12/12/2001 12/14/2001 2 NONE PUB PUB PPD/Aventis/C0867AB/SC/RFA NONE NONE 1
0179482 12/27/2001 FL 5.0 5 M 12/20/2001 The pt's left deltoid became red, swollen and warm to touch. Y 12/18/2001 12/19/2001 1 PVT OTH NONE 1
0179483 12/27/2001 WI 5.0 5 F 12/19/2001 The pt developed an area 18cm X 21cm of redness and induration on left upper arm. Y U 12/17/2001 12/17/2001 0 PVT PVT NONE NONE 1
0179484 12/27/2001 MT 43.0 43 F 12/10/2001 The pt developed diarrhea which lasted 4 days. She had nausea but no vomiting. No fever. Supportive care only. I suspect viral syndrome but the pt is convinced that this is an adverse reaction. Y Y 12/06/2001 12/07/2001 1 CBC; CMP-WNL; D & P; C & S; Occult blood C difficile-all negative for pathology PVT PVT Valium; Celexa NONE Mood disorder 1
0179485 12/27/2001 NY F 12/18/2001 Pt developed a fever of 104F-105F X 96 hours. Y Y 12/05/2001 12/05/2001 0 Throat culture; UA; CBC-nml PVT PVT NONE NONE Pyelonephritis 8/27/01 1
0179486 12/27/2001 GA 3.2 3 F 12/20/2001 The pt developed chickenpox and was rx'd Atarax and Calamine. Y Y 09/27/1996 12/18/2001 1908 PVT PUB Albuterol; Intal UNK Asthma 1
0179487 12/27/2001 WA 4.0 4 F 12/17/2001 The pt vomited X 1 the following morning, post vax. He possibly had a fever (mom does not know) and was given a fever reducer. She was better in the afternoon. By 19:00, she had jerky movements but awake. Also had a headache. By 22:00 went to ER and had no symptoms. Y Y 12/05/2001 12/06/2001 1 NONE PVT PUB NONE NONE 1
0179488 12/27/2001 SD 10.0 4 M 12/11/2001 Chickenpox; body covered with pox and ill. Y 01/24/1996 12/10/2001 2147 PVT PVT NONE 1
0179489 12/27/2001 PA 47.0 47 F 12/17/2001 The pt developed tingling of her tongue, face and neck 1/2 hour later. She states that it is itchy around her mouth and face. Rx'd Benadryl and Claritin and it improved within a few hours. Y 12/14/2001 12/14/2001 0 PVT OTH E-Vista Codeine (ionic contrasts) 1
0179490 12/27/2001 IL 1.0 0 1 M 12/14/2001 The pt received Varivax in 4/98. He presented today with mild to moderate chickenpox lesions when seen by MD on 12/6/01. Y 04/01/1998 12/06/2001 1345 PVT OTH Viral URI 1
0179491 12/27/2001 FL 1.0 1 .0 F 12/18/2001 Broke out in chickenpox. Y Y 08/01/1996 12/13/2001 1960 PVT OTH NONE NONE 1
0179492 12/27/2001 CA 4.0 4 F 12/05/2001 The pt's right arm was swollen and red and she was given Keflex antibiotics. Y 12/03/2001 PVT PVT PPD/LFA NONE NONE 1
0179493 12/27/2001 DC 4.0 4 M 12/13/2001 Complained of progressive swelling at both injection sites approximately 1.5 cm, red, warm, firm, slightly tender. Treated with ice packs and acetaminophen. Had full ROM of extremity. U 12/04/2001 12/12/2001 8 OTH PUB 1
0179494 12/27/2001 NY 2 .8 F 12/17/2001 Varicelliform rash noted 11/29/2001 (approximately 20-100 lesions). Y Y 02/23/1996 12/17/2001 2124 PVT PVT NONE NONE 1
0179495 12/27/2001 NY 1.4 1 .4 M 12/17/2001 Febrile seizure Y Y 12/14/2001 12/17/2001 3 PVT PVT NONE URI symptoms NONE 1
0179496 12/27/2001 PA 1 .2 M 12/14/2001 Approximately 30 papulo-vesicular lesions scattered over entire body. Y Y 07/18/1995 12/12/2001 2339 PVT UNK NONE 1
0179497 12/27/2001 CA 0 1 M Varicelliform rash after VZV vaccine. Y 11/01/2001 11/12/2001 11 NONE PVT PUB NONE Otitis Media without fever NONE 1
0179498 12/27/2001 WA 4.0 4 M 12/13/2001 Pt given DTaP and IPV in left upper arm. Twenty-four hours later complained of itching and discomfort. Forty-eight hours later noted to have redness, firm swelling, itching in area of immunizations. There is no fever or tenderness. No axillary node swelling. Y 12/11/2001 12/12/2001 1 NONE PVT PUB NONE Mild RAD 1
0179499 12/27/2001 MI 0.5 0 .5 M 12/20/2001 Mom reports infant irritable for 2 days after immunization on 11/07/2001 lasting 2 days. Rash appeared on 11/12/2001. Rash blotchy, head to toe. Denies any raised areas or swelling. No other symptoms. Irritability increased. ER visit on 11/12/2001. Was told rash was reaction immunization. Told to give Benadryl. States Benadryl given every 4 hours for 2 days. Noticed improvement after first day given. States ER MD advised continue with routine immunizations. Y Y 11/07/2001 11/12/2001 5 NONE PUB PUB NONE NONE NONE 1
0179500 12/27/2001 MD 11.0 6 F 12/20/2001 Varivax given 08/15/1996. Varicella diagnosed 12/20/2001. Y 08/15/1996 12/17/2001 1950 PVT PVT NONE 1
0179501 12/27/2001 NY 4.0 4 M 12/18/2001 Mother returned with child approximately 1/2 hr after he received immunizations. Generalized rash on all extremities bilaterally. No rash noted on trunk. Mucous membranes pink. Rash over cheeks. Eyes swollen. Child itching. Ambulance called. Child transported to ER. Y Y 12/18/2001 12/18/2001 0 PUB PUB NONE NONE NONE 1
0179502 12/27/2001 IN 25 F 12/10/2001 Twenty-five minutes after vaccination pt complained of redness at site, slight itching. Examine sight, no local swelling. Local irritation. Gave pt ice pack, re-examined pt before I left pt was fine. Y 12/06/2001 12/06/2001 0 OTH UNK NONE Allergy to PCN 1
0179503 12/27/2001 NJ 2.0 1 1 M 12/17/2001 Two days later developed hard induration and 3-4 palm area of redness with warmth. No pain, fever or limit of motion. U 12/13/2001 12/15/2001 2 NONE PVT PUB Allergic rhinitis 1
0179504 12/27/2001 LA 45.0 45 F 12/10/2001 Pt reported 12/07/2001 a day after receiving the TD vaccine she notice itching at the injection site with redness and swelling. On 12/20/2001 she reported it was warm to touch. She plans to go to ER. Y U 12/06/2001 12/07/2001 1 PUB OTH Robitussin (PRN) Right foot wound from stepping on car jack. PCN LA011201 1
0179505 12/27/2001 NH 4.0 4 F 12/17/2001 Twenty-four to forty-eight hours following vaccination with DTaP, left upper arm became painful, red, swollen and no septenic symptoms. Pt given pediopred and Benadryl (5 day course). Y 12/12/2001 12/14/2001 2 PVT PUB NONE NONE NONE 1
0179506 12/27/2001 WV 16.0 16 M 12/21/2001 Pt was given 1st dose of Hepatitis B on 11/20/2001. Mother reported that he started having hives on 11/21/2001. Hives migrated and appeared off 1 cm for the next 6 days. Y 11/20/2001 11/21/2001 1 NONE PVT PVT NONE NONE NONE WV0114 1
0179507 12/27/2001 TN 73.0 73 M On 10/29/2001 pt received pneumococcal and flu vaccines. Developed swelling, redness, pain and fever at pneumococcal injection site. Flu vaccine was given in opposite arm without problem. Medical record flagged for no future doses of pneumococcal vaccine. Report filed with FDA. 10/29/2001 10/29/2001 0 NONE UNK UNK NONE BPH 1
0179508 12/27/2001 66.0 F Injection given on 12/06/2001 in right deltoid IM. On Saturday 12/08/2001 arm was very swollen no pain. Went to Med Center and received IV and medication Keflex 500 mg QID. Returned on 12/09/2001 to ER due to swelling down to elbow and received another IV. Y 12/06/2001 12/08/2001 2 NONE UNK UNK NONE ASA Allergy 1
0179509 12/27/2001 TN 1.08 1 .2 F 12/06/2001 Two week after receiving DTaP, IPV, Comvax, MMR, CPX child was seen in ER because of listlessness. She (mother said) PMD said child was dehydrated and ordered Pedialyte (nothing else). Mom said ER report said "Viral Immunization Sequallae". Symptoms lasted 3-4 days? Y Y 11/14/2001 12/01/2001 17 NONE PUB PUB NONE NONE TN01064 1
0179510 12/27/2001 TN 30.0 30 F 12/09/2001 On 11/07/2001 pt woke up 4 AM with temp 104.6, took antipyretic, stayed in bed all day, felt bad and ached all over. Face swollen, no difficulty breathing, stayed in bed. Thursday temp of 100 F. Still had joint pain with movement. No seizure activity. Y 11/06/2001 11/07/2001 1 NONE PUB PVT Clonazpam History of Epilepsy Allergy to terbutaline sulfate; history of epilepsy TN01065 1
0179511 12/27/2001 ME 4.0 4 F 12/18/2001 Seen on 12/16/01 after hours with increased swelling (5cm X 8cm) and redness with itching over the past 24 hours. Left arm is swollen from the shoulder to the elbow and hot to touch. Dx'd with a large local reaction and questionable cellulitis. The area was marked and parents were instructed to call if there is an increase in swelling or any fever. U 12/14/2001 12/15/2001 1 NONE PVT PUB NONE NONE NONE ME01046 1
0179512 12/27/2001 ME 38.0 38 M 12/07/2001 Soreness, knot (local) slightly red size of 50 cent piece, pinkish and raised. Y 12/13/2001 12/13/2001 0 PVT UNK ME01047 1
0179513 12/27/2001 MI 12.0 12 F 12/14/2001 The pt had her 1st HBV, 1 month ago at school. The next day she had a fever over 100F, swollen and sore throat, lymph glands swollen and chills. The 2nd HBV was given on 12/13/01. Mom states she had the same symptoms. Has had similar symptoms with strept infection but no fever in the past. Seen by a new doctor today. Y U 12/13/2001 12/13/2001 0 OTH OTH NONE History of strept infection Fever, swelling and soreness of throat, lymphadema and chills~Hep B (Recombivax HB)~1~12.00~In Patient 1
0179514 12/27/2001 MI 14.0 14 F 12/06/2001 Client developed a welt on left deltoid the night of the injection 10/16/2001. On 10/17/2001 the welt wrapped around arm and was hot to touch. By 10/19/2001 the welt was about an inch in size. Client continues to complain of achiness in left arm. Mom took her in to se MD on 12/06/2001 for continued achiness. MD encouraged her to call in and make appointment. No treatment. Continues to complain of pain. Y N 10/16/2001 10/16/2001 0 NONE PUB PUB NONE NONE NONE MI2001100 1
0179515 12/27/2001 TN 4.0 4 M 12/21/2001 24 hours, post vax, the pt developed local swelling about the size of a silver dollar and a rapid increase in size over the next 24 hours requiring ED visit where pt was thought to have possible cellulitis. An office visit, 3 days post vax, showed an area of non-tender erythema (5cm X 8cm) of the thigh at the site of the DTAP or MMR. Y Y 12/07/2001 12/08/2001 1 NONE PVT PUB Omnicef Resolving otitis media NONE ~DTP (no brand name)~~0.00~In Sibling|~DTP (no brand name)~~0.00~In Sibling 1
0179516 12/27/2001 CA 3.0 0 1 F 12/21/2001 The pt presented to the physician's office with clusters of vesicles and erythematous patches over her right arm and hand. Dx'd with herpes zoster by MD. Pt has not had chickenpox. Mother did not have chickenpox during pregnancy. Y 07/16/1999 12/14/2001 882 PVT PVT NONE NONE NONE 1
0179517 12/27/2001 CO 2.0 1 .2 F 12/18/2001 The pt received Varivax on 4/20/99 and on 11/30/01 the child broke out with a full blown case of chickenpox. Mom wanted your to be aware that the shot was not effective. Y 04/20/1999 11/30/2001 955 PUB OTH NONE NONE Low birth weight and 3 weeks early. 1
0179518 12/27/2001 MO 1.1 0 .5 M 12/17/2001 On 6/11/01, DTAP #3 was ordered; DT pediatric given instead (lot 470641 Lederle). Discovered when the pt was here for #4 DTAP on 12/17/01. Vaccine DTAP was given. Called vaccines for Children and Health Dept for instructions. To give DTAP in 6 months (in 6/02), then next shot will be due prior to starting school at age of 4-6 years. Advised that there should be no adverse effects if booster given in June, 2002. Y 06/11/2001 PVT OTH NONE NONE History of URI (viral) and rhinitis 1
0179519 12/27/2001 AL 81.0 81 M 12/18/2001 The pt's skin in the area around the shot is turning yellow. No pain or inflammation in shot area. U 12/10/2001 12/17/2001 7 OTH OTH 1
0179520 12/27/2001 NJ 51.0 51 M 12/18/2001 At 15:00, the pt had a sore left arm associated with hot and cold chills, headache and nausea. At 17:00, he was seen in the ER with a temperature of 100.3F. Y Y 12/10/2001 12/10/2001 0 WNL PVT PVT NONE NONE Ring hernia; COPD; Reflux 1
0179521 12/27/2001 MT 52.0 52 F 12/17/2001 The pt developed redness, heat and tenderness the day after the shot on 12/13/01. The doctor gave cefadroxil 500mg BID. Y Y 12/12/2001 12/14/2001 2 NONE PUB PUB Prilosec; Avonex; Zestril; Azmacort; Serevent; amitriptyline; Letryrarine ? MS 1
0179522 12/27/2001 NJ 1.3 1 .0 M 12/20/2001 The child presented with vesicular rash on face and extremities on 12/11/01. Mom stated that the rash had appeared the day before and was not itching. The pt was not in any distress and was afebrile. He had no respiratory signs or symptoms upon exam. Y U 08/09/2001 12/10/2001 123 NONE PVT PVT NONE NONE NONE 1
0179523 12/28/2001 MD 14.0 F 12/03/2001 A nurse reported that a 14 year old female pt experienced itching, redness, swelling, difficulty breathing and throat swelling during treatment with RabAvert therapy. The pt's medical history included allergies to PCN and bee stings. She began her post exposure vaccination series of RabAvert 1 ml IM on day 0, 07-SEP-2001. The pt received her first and second shots without any reported problems. She received her third shot on 14-SEP-2001. On 16-SEP-2001 the pt developed severe itching and redness around the face and neck area as well as some swelling around the eyes. On 17-SEP-2001 the pt was hospitalized for difficulty breathing and throat swelling. She was treated with epinephrine and adrenaline and the symptoms subsided. She was discharged on 19-SEP-2001. the pt was scheduled to receive her fourth dose of RabAvert on 21-SEP-2001, instead she received HDCV on 22-SEP-2001. The pt again experienced throat swelling and difficulty breathing and was treated with epinephrine and adrenaline. As of 26-SEP-2001 the subject had discontinued RAbAvert and the symptoms had resolved. The pt is scheduled to visit and allergist and a dermatologist. the physician assesed this event as possibly related to RabAvert. Y Y 2 Y 09/14/2001 09/17/2001 3 OTH OTH NONE UNK Allergy to penicillin and to bee stings (toxic effect of venom) EM20011120 1
0179524 12/28/2001 NJ 54.0 53 M 12/13/2001 See hospital records and Neurologist report. (none attached) Y Y 10 Y N 12/08/2000 12/20/2000 12 PVT UNK Glucotrol; Atenolol; Norvasc; Minitran; Plavix; Zestril; Lipitor; Nitrostat; ASA NONE NIDDM; Hyperlipidemia; CAD 1
0179525 12/28/2001 IL 68.0 68 M 12/20/2001 Pt developed pain in back and foot with partial loss of sight in left eye. Y N 04/22/1999 Tested positive for Lyme by Western Blot and Elisa PVT PVT NONE back injury x 3 with stress fracture of t-12, prostate CA, Lyme DX in 1998, short leg syndrome, umbilical hernia Lyme~Lyme (LYMErix)~3~66.00~In Patient 1
0179526 12/28/2001 NC 54.0 54 M 12/20/2001 Pt developed severe headache 6 days after receiving flu vaccine (11/15). On 11/16 began to notice decreased vision in right eye. Went to ER. Over next several days, lost vision both eyes. Headache continued until 11/29. Hospitalized on 11/27. Treated with steroids. now beginning to regain some vision. Y 5 Y 11/09/2001 11/15/2001 6 MRI-wnl; LP fluid-wnl; CT Scan of head-wnl (11/16/01) OTH PVT NONE Sinus infection Arthritis 1
0179527 12/28/2001 SD 1.5 1 .5 F 12/19/2001 Received injection listed and the very next morning demonstrated temp of 105and febrile seizure. Hospitalized for one day. physician unable to associate symptoms with illness. Y 1 Y 12/17/2001 12/18/2001 1 PVT OTH NONE NONE SD01008 1
0179528 12/28/2001 ID 66.0 66 F Swelling of right arm, tightness in chest, Couldn't hardly breathe, every bone in body ached, fever off and on for three days. Treatment by MD, put ice on arm and take Tylenol. Y Y 10/31/2001 OTH UNK PPV NONE NONE 1
0179529 12/28/2001 WA 56.0 56 M 12/16/2001 Became ill 1 hour after receiving injection has missed 10 days of work from 11/21/2001-12/16/2001 complained of fatigue, nausea, SOB and cough. Cough causes and diminishes and breathlessness and vomiting. Still having SOB and fatigue. Body aches. U 11/12/2001 11/12/2001 0 CXR-negative MIL OTH NONE Seasonal allergies severely ill~Influenza (Seasonal) (no brand name)~1~31.00~In Patient 1
0179530 12/28/2001 AZ 64.0 64 M 12/22/2001 Flu shot was given on 11/09/2001. Thirty-six hours later I had a temperature and the chills and shakes so bad that I had to hold my jaw shut to keep my teeth from breaking. Entire body was shaking violently for 2 hrs. Same thing happened 60 hrs later after shot given. Y 11/09/2001 11/10/2001 1 PUB UNK Niaspan, Cardizem and Prilosec NONE Allergic to PCN; had 4 angioplasties and 5 stents 1
0179531 12/28/2001 MD 55.0 55 F 12/13/2001 12/4/2001 Immunized. 12/10/2001 Pain in deltoid area with swelling, redness 7 cm in area. 12/11/2001 Pain returned to shoulder, elbow, clavicle and shoulder blade. 12/13/2001 Saw MD. Y 12/04/2001 12/10/2001 6 PUB PUB NONE Tuberous Sclerosis; Sixth cranial nerve palsy 1
0179532 12/28/2001 NY 26.0 26 M 12/19/2001 Localized reaction, red, hot swollen, pain in triceps with internal rotation of arm morning of 12/13/2001. Friday 12/14/2001 saw personal physician, gave him Zyrtec, drew circle around reddened area, told pt to return if swelling extended beyond circle. Revisit to MD, put him on 3 days of antibiotic, doesn't remember name. Y Y 12/12/2001 12/13/2001 1 NONE PUB PUB NONE NONE NONE 1
0179533 12/28/2001 TX 63.0 63 F 12/20/2001 Day received 11/07/2001 Evening achy arm, itch, red, slight swelling. 11/08/2001 Same as above but with welts from inside elbow to injection site, slight fever 100. 11/09/2001 Same as abve but less so. Right arm pneumonia. Y 11/07/2001 11/07/2001 0 PUB OTH Premarin; Celebrex; Neurotin; Propecia: vitamins NONE Thyroid surgery 1
0179534 12/28/2001 RI 67.0 67 F 11/20/2001 11/16/2001 pt had flu hot and within 24 hours developed Iritis. diagnosed and treated by a Opthamologist. Y 11/16/2001 11/17/2001 1 PUB PVT NONE UNK iritis~Vaccine not specified (no brand name)~~0.00~In Patient 1
0179535 12/28/2001 NY 60.0 60 M 12/20/2001 Aches all over body, fevers, pain urinating, runny nose, frequent urination. Y 12/17/2001 12/17/2001 0 PUB OTH Aldomet; Water pill Hypertension Hypertension 1
0179536 12/28/2001 MA 43.0 F 12/06/2001 Twenty-four hours after receiving shot experienced hives. Y 12/01/2001 12/02/2001 1 PUB PUB 1
0179537 12/28/2001 MN 0.2 0 .1 M 12/17/2001 Fussiness, inconsolable and temperature. Y 12/11/2001 12/11/2001 0 PVT PVT NONE Eczema NONE 1
0179538 12/28/2001 VA 0.3 0 .3 F 12/20/2001 Screaming episode for 3 hours during nite. Temp 101.3 okay 12/19/2001. Y 12/18/2001 12/19/2001 1 PVT PVT NONE NONE NONE 1
0179540 12/28/2001 FL 1.0 1 .5 M 12/21/2001 Large swelling and redness, gradually increased over 3 days. Today site is 15cm by 8 cm. Treated with 1 tsp Benadryl PO. Y U 12/08/2001 12/19/2001 11 MIL MIL NONE NONE 1
0179541 12/28/2001 MD 1.0 1 .0 M 12/20/2001 11 by 20 mm area of vesicles developed 5 days after immunization with Varivax around injection site on left leg. U 12/06/2001 12/11/2001 5 PVT PUB NONE NONE History of hives after eating eggs and also with whole milk. 1
0179542 12/28/2001 GA 5.0 1 .0 F 12/18/2001 Chicken pox diagnosed 12/17/2001. Treated with Zovirax 400 mg QID for 5-7 days. Y Y 09/08/1997 12/16/2001 1560 PVT PVT NONE NONE 1
0179543 12/28/2001 AK 1.5 1 .6 F 12/17/2001 Allergic reaction to Egg in shot, severe constipation, stomach ache, lack of sleep and pain spasms for 2 days and nights, then vomiting and diarrhea and rash all over body. Treated with Benadryl. Y Y 09/28/2001 09/28/2001 0 MIL MIL Tylenol Cold Allergic to milk, eggs and peanuts. 1
0179544 12/28/2001 ME 66.0 66 F 12/18/2001 Diffuse myalgia, anthralgia, fever, localized redness, warmth and tender. Y 12/14/2001 12/15/2001 1 NONE PVT UNK NONE 1
0179545 12/28/2001 IA 1.0 1 .6 M 12/17/2001 Pt was administered DTaP in right thigh, Comvax in left thigh and MMR in left deltoid on 12/13/2001 at 4:30 PM, further reports right thigh and below swelled and turned red during night, warm to touch. Y 12/13/2001 12/14/2001 1 PVT PVT Started on Zithromax 12/13/2001 Rhonchi L and R NONE 1
0179546 12/28/2001 OH 6.0 1 .1 M 12/19/2001 Received varicella at age 1 year ant 12/18/2001 developed varicella. His mother called and described, the doctor did not diagnose. U 11/25/1996 12/18/2001 1849 PVT PVT Mantoux Lot #242411 right arm UNK Eczema 1
0179547 12/28/2001 CA 44.0 43 M 12/20/2001 Pt received Twinrix A/B IM vaccine 12/14/2001 and state next day later in evening had liquid stool with possible blood in it. Y 12/14/2001 12/15/2001 1 OTH PUB Nizoral shampoo and Protonix tabs. 1
0179548 12/28/2001 NY 3.0 3 F 12/06/2001 Child developed fever 102.6, vomited 12/06/2001 presents with sore arm. Y Y 12/04/2001 12/05/2001 1 NONE PUB PUB NONE NONE NONE 1
0179550 12/28/2001 CA 47.0 46 F 12/26/2001 Fever, chills, right hip pain. Started immediately after; so severe almost went to ER. Lasted approximately 24 hours. Rest and ibuprofen. Y 12/12/2001 12/12/2001 0 NONE PVT PVT Levaquin, ibuprofen, Flovent and Serevent. Bronchitis with RAD Asthma, recent LBP-work injury. 1
0179551 12/28/2001 MN 0.4 0 .4 M 12/27/2001 Hives on trunk within 2 minutes of injection 3 ml of Benadryl given PO. Hives had subsided by the time the pt left over 1 hour. Y 12/26/2001 12/26/2001 0 NONE PVT OTH NONE hives~Vaccine not specified (no brand name)~1~0.00~In Patient 1
0179552 12/28/2001 FL 56.0 M 12/03/2001 A 54 year old male pt experienced encephalopathy following treatment with RabAvert for post exposure prophylaxis. the pt was bitten and scratched by a stray cat. He had previously received two full courses of human rabies immune globulin and 5 injections of post exposure rabies vaccine in the US about 9 to 10 years ago. He had not received any rabies booster shots since that time. The pt received one dose of post exposure RabAvert without human rabies immune globulin on 30-JAN-01 after stray cat bite. He did not receive his second dose because he experienced "encephalopathy" after the first RabAvert dose and the pt was hesitant to obtain either RabAvert or Imovax for the second dose. No titer was taken prior to the first dose and at the time of this report, it had been 7 days since the first dose. Follow up information is pending. ADDITIONAL INFORMATION: Follow up information was received on 27-FEB-01. The pt was 56 years of age (correction). Twenty-four hours after his last dose of RabAvert on 30-JAN-01 at 1600, he experienced tachycardia, a fever 100 degrees F, and chills which lasted 24 hours; menigismus which lasted 2 to 3 days; and difficulty concentrating which lasted 5 days. His diagnosis was mild encephalitis and he recovered on 21-FEB-01. Y 01/30/2001 01/31/2001 1 PUB OTH NONE UNK Contact with or exposure to Rabies. EM20010238 1
0179553 12/28/2001 TX 49.0 F 12/03/2001 A 49 year old female experienced fatigue and arm pain on 28-NOV-2000 following vaccination with RabAvert for post exposure prophylaxis. Three or four days before her first RabAvert injection (21-NOV-2000), the pt was providing food to a raccoon and was bitten on the bottom of her left hand. She received a small "barely broken" skin wound which she cleaned with hydrogen peroxide and alcohol. At the time of this report, 10-JAN-01 she has since seen the raccoon alive. The pt was vaccinated with RabAvert on 21-NOV-2000 in the deltoid and also treated with human rabies immune globulin in the hips. No adverse events occurred. On 25-NOV-2000, she was vaccinated at a different clinic in her hips. She experienced fatigue. On 28-NOV-2000, she was vaccinated with her third vaccination in the arm. She experienced fatigue and arm pain at the injection site, sweating which she felt was "hormonal", headaches which she has recovered from and an achy jaw which she stated was from her history of temporomandibular joint disorder. the pt stated that her achy jaw symptoms improved with treatments from her chiropractor. On 05-DEC-2000 and 19-DEC-2000 she received her fourth and fifth vaccinations respectively and experienced weakness and arm pain at the injection sites both times. She stated that her fatigue has improved but she has not fully recovered. her arm pain and weakness are still persisting. Around 08-JAN-2001, the pt experienced weakness in the legs, back and neck which she does not feel is due to the RabAvert vaccinations. Her physician states that he will investigate possible rheumatoid arthritis or lupus. Y On 09-Jan-2001, a CBC, CP 12,ESR and ANA were all normal. OTH OTH She is taking Xanax for the panic attacks. UNK Temporomandinular joint disorder, panic attacks and hot falsehes. EM20000713 1
0179554 12/28/2001 CA 20.0 M 12/03/2001 A 20 year old male experienced fever, headache, and vomiting on 12/11/2000 after receiving RabAvertfor postexposure prophylaxis. The patient was previously immunized two years ago, in 1998, with 3 doses of rabies vaccine. he was bitten by a skunk while working at the zoo. Twenty-four hours after his first dose of RabAvert on 12/10/2000, the patient developed a fever of 192 degrees F, headache, nausea and vomiting. He recovered on 12/13/2000. On 12/14/2000, the subject was vaccinated with Imovax Im lot #R1105. the treating physician believed that the adverse events were due to gastroenteritis and not related to the RabAvert vaccine. The patient is currently taking oral Augmentin. Y Y 12/10/2000 12/11/2000 1 PVT PVT Augmentil Unknown contact with or exposure to rabies EM2000-0799 1
0179555 12/28/2001 FL 30.0 F 12/03/2001 A 30 year old female pt experienced nausea and dizziness on the evening of 29-DEC-2000 following her vaccination with RabAvert that day. On 19-DEC-2000, the pt had been working in a veterinarian's office when she received approximately 6 wounds to her hand from a dog bite. the dog had terminal cancer and was euthanized at another location before tissue samples for rabies analysis were obtained. The dog owner had refused to quarantine the dog for the required 10 days after the bite despite being informed of his obligations. The pt received her first dose of RabAvert on friday, 29-DEC-2000. She also received human rabies immune globulin. That evening, she had complaints of nausea, dizziness and was unable to stand. She also experienced severe abdominal pain at approximately 0100 Saturday morning. All events resolved that evening. The pt discovered that she was pregnant on approximately 01-JAN-2001. This is her third pregnancy. Her pregnancy due date is 10-SEP-2001. On Tuesday, 02-JAN-2001, the pt received her second dose of RabAvert. She again experienced dizziness which resolved on Wednesday morning. On Friday, 05-JAN-2001, the pt received her third dose of RabAvert with no adverse events experienced. She stated that she will be seen soon for prenatal care. Y 12/29/2000 12/30/2000 1 PUB OTH Rabies Immune Globulin UNK EM20010014 1
0179556 12/28/2001 TX 9.0 M 12/03/2001 A 9 year old male experienced fever, flu-like symptoms, headache, stomach ache, and leg pain following vaccination with RabAvert for post exposure prophylaxis. The pt was exposed to a bat which was tested positive for rabies, received RabAvert and human rabies immune globulin. After the first dose of RabAvert, he developed fever and flu-like symptoms. There were no adverse events after the second dose. After the third dose, the pt experienced headache, stomach ache and one of his legs was hurt. Follow up information is pending. U OTH OTH Human rabies immune globulin UNK EM20010263 1
0179558 12/28/2001 TX F 12/03/2001 A female patient (age unknown) experienced nausea, vomiting, chest pain, fever, and hypertension on 4/14/01 following treatment with RabAvert for postexposure prophylaxis. The patient was bitten by a raccoon on 4/9/01 and began postexposure vaccination on 4/13/01. On 4/13/01 she received human rabies immune globulin into an around the site of the wound, and RabAvert was given IM in her arm. Approximately 2 hours later, the patient began to feel edgy, hot and sick to her stomach. The next day, she presented to the emergency room with nausea, vomiting, chest pain, fever, and hypertension. She was treated with IV fluids and sent home. On 4/16/01, the patient returned to the emergency room for her second dose of RabAvert. She did not develop any adverse experiences following the second dose of RabAvert. The patient missed her third and fourth doses of RabAvert. She was due into the clinic on 4/30/01 for her third dose of postexposure RabAvert and would then try to complete the postexposure schedule per the approved regimen. The Drug Safety physician assessed that human rabies immune globulin as a secondary suspect product. Follow up information has been requested. Y Y 04/13/2001 04/13/2001 0 A female patient( age unknown) experienced nausea, vomiting, chest pain, fever and hypertension on 04/14/2001 following treatment with RabAvert for postexposure prophylaxis. the patient was bitten by a raccoon on 04/09/2001 and began postexposure vaccination on 04/13/2001. On 04/13/01, she received human rabies immune globulin into and around the site of the wound, and RabAvert was given IM in her arm. approximately 2 hours later, the patient began to feel edgy, hot and sick to her stomach. the next day, presented to the emergency room with nausea, vomiting, chest pain, fever, and hypertension. she was treated with intravenous fluids and sent home. On 04/16/01, the patient returned to the emergency room for her second dose of RabAvert. She did not develop any adverse experiences following the second dose of RabAvert. OTH OTH Unknown contact with or exposure to rabies EM20010564 1
0179559 12/28/2001 37.0 M 12/03/2001 A 37-year old male consumer reported experiencing a fever, a sore throat and tiredness coincident with RabAvert post-exposure vaccination therapy. The consumer's medical history included occasional pollen allergy for which he takes Proventil via an inhaler and no known drug allergies. He received day 0 and day3 of post-exposure therapy for RabAvert 1 ml IM (exact date unk. He developed a fever of 100-degrees F. As of 06/21/2001, the subject was scheduled to receive day vaccination and it is unknown whether the events had resolved. OTH OTH Proventil Unkown Need for prophylaxis vaccination and inoculation against rabies Allergy, unspecified, not elsewhere classified EM2001-0778 1
0179560 12/28/2001 TX 51.0 F 12/03/2001 A fifty-one female experienced fatigue following the third dose of post-exposure RabAvert. Following her forth dose of RabAvert, the patient experienced a headache, swelling in the gums and taste buds, and severe fatigue. The patient received B-12 concurrently with the forth dose of RabAvert. U OTH OTH Vitamin B12 Unknown Need for prophylaxis vaccination and inoculation against rabies 1
0179561 12/28/2001 TX F 12/03/2001 A female patient, in her early forties, experienced fever and vomiting after receiving RabAvert. The patient is an animal handler with no medical diagnosis. she received her first dose of RabAvert for pre-exposure prophylaxis on 07/11/2001. On 07/14/2001, the patient complained of fever of 103 degrees and vomiting. The fever was self treated with acetaminophen and the vomiting was untreated. The symptoms resolved after two days. Y 06/11/2001 06/14/2001 3 PVT OTH No other medications Unknown Need for prophylactic vaccination and inoculation against rabies 1
0179562 12/28/2001 WI 4.0 U 12/03/2001 A 4 year old male experienced muscle pain, fever of 103F, headache and nausea and vomiting after being treated with RabAvert. The pt received RabAvert post-exposure rabies prophylaxis. He received his 3rd dose (date unknown) and experienced the adverse events. Concurrent medications were unknown. Follow-up information has been requested. U OTH OTH NONE UNK Contact with or exposure to rabies EM20011001 1
0179563 12/28/2001 NY 18.0 F 12/03/2001 A pharmacist reported that an 18 year old female experienced nausea, left-sided numbness and dizziness coincident with RabAvert post-exposure vaccine therapy. The pt was reported to have an allergy to shellfish. The pt was exposed to a bat in a cabin while camping. The pt received her 5th post-exposure RabAvert injection (all doses were reportedly given on time) in the left deltoid on 8/16/01. She experienced nausea, weakness, left-sided numbness, dizziness and was hyperventilating. There was no local reaction at the injection site. On 8/17/01, a physician in an ER dx'd her as having "hyperventilation syndrome" and possible "mild serum sickness" and felt that the pt had probable "viral syndrome". The pt also experienced numbness to her fingertips, nausea, dizziness and questionable consciousness. The pt was treated with Vistaril 50mg, IM, in the ER. As of 8/29/01, it is unknown whether the pt received any further injections of RabAvert or whether the events resolved. Y U 08/16/2001 08/17/2001 1 OTH OTH Zantac UNK Allergy (unspecified, not elsewhere classified) to shellfish; exposed to a bat. EM20011061 1
0179564 12/28/2001 NY 21.0 F 12/03/2001 A 21 year old female experienced dizziness, pain at the injection site, weakness and left arm tenderness after receiving RabAvert. The pt, along with another female, was exposed to a bat in a cabin at a camp. She received her 5th post-exposure RabAvert injection in the left deltoid on 8/16/01. She presented to the ER with dizziness, pain at the injection site, weakness and left arm tenderness. The physician in the ER dx'd her as having exhaustion and possibly "mild serum sickness". The physician recommended taking Tylenol or Advil. Subsequent follow-up, revealed that a 3rd female, exposed from the same cabin and treated with Imovax, presented to the ER complaining of similar symptoms. The physician determined that each pt had a probable "viral syndrome". The events did not meet any of the serious criteria. The outcome, is unknown, as the pt was visiting the area when the events occurred. Y U 08/16/2001 08/16/2001 0 NA-138; K-4; Cl-101; CO2-26; BUN-6 (low); Ca-1.8 (low); RDW-11.3; Neutrophil-74.5; lymphocytes-14.4 PVT OTH NONE UNK Exposed to a bat EM20011062 1
0179565 12/28/2001 FL 4.0 F 12/03/2001 A 4 year old female developed a rash following RabAvert administration. The pt received her 2nd dose of RabAvert 1ml, IM, in her leg on 8/28/01 (Day 3) for post-exposure vaccination. On 8/31/01, the pt developed a rash on her arms. U 08/28/2001 08/31/2001 3 OTH OTH NONE UNK Need for prophylactic vaccination and inoculation against rabies EM20011073 1
0179566 12/28/2001 TX 27.0 F 12/03/2001 A 27 year old female experienced a severe headache, chills, sweating and gastrointestinal discomfort (nausea and vomiting) following the 2nd and 3rd doses of post-exposure RabAvert vaccination. Symptoms began on 9/4/01 and persisted for approx. 3 days. Y 09/04/2001 PUB OTH NONE UNK Need for prophylactic vaccination and inoculation against rabies. EM20011094 1
0179567 12/28/2001 WI 47.0 F 12/03/2001 A 47 year old female experienced hair loss coincident with RabAvert therapy. The pt received her 1st dose of post-exposure RabAvert on 6/1/01. She noticed hair loss at the beginning of August. The pt reported that the hair loss was severe and bald spots on her scalp were noticeable. In the beginning, the bald spots were the size of a dime, however as of 9/18/01, one bald spot was the size of a half-dollar and the 2nd one was the size of a quarter. The pt's physician treated her condition with an injection of corticosteroid into the scalp area (8-10 injections per spot). U 06/01/2001 08/01/2001 61 OTH OTH Premarin UNK Need for prophylaxis against rabies EM20011115 1
0179568 12/28/2001 TX 2.0 F 12/03/2001 A 2 3/4 year old female was exposed to a rabid bat and was treated with RabAvert and rabies immune globulin for post-exposure prophylaxis. Twenty minutes, post vax, the pt developed urticaria and facial swelling which was successfully treated with Benadryl. The pt has had no previously known drug allergies. Follow-up information is pending. Y OTH OTH Rabies Immune Globulin, Human UNK Exposed to rabid bat. Em20000617 1
0179569 12/28/2001 MD 35.0 F 12/03/2001 A 35 year old female experienced hives, fever and injection site redness and warmth on 12/24/00 following RabAvert vaccination for post-exposure prophylaxis. The pt received post-exposure RabAvert because she was caring for a sick kitten who was attacked by a raccoon. She received her 1st RabAvert vaccine on 12/17/00 and the 2nd vaccine on 12/20/00 with no adverse events experienced. After the 3rd vaccine was given on 12/24/00 (lot 273011), the pt developed hives from the mid-chest down to her feet which were raised, red ant itchy. She also had a fever and experienced redness and warmth at the site of the injection on her arm. The pt, an RN, treated herself with Benadryl (dose unknown) and the hives were resolved. After the 4th RabAvert vaccine on 12/31/00 (lot 273011), the pt again developed hives from the mid-chest down to her feet (raised, red and itchy), but the intensity was less than after the 3rd dose. She again treated herself with Benadryl (dose unknown) and the problem was resolved. (She did not pre-medicate herself with Benadryl prior to the 4th vaccine). The pt also experienced redness and warmth at the site of the injection on her arm after the 4th dose. The pt has no known medical conditions, allergies or long-term medications. The pt's son also received post-exposure RabAvert vaccinations with lot 273011, but he had not experienced any adverse events. Y 12/24/2000 12/24/2000 0 OTH OTH NONE NONE The pt was caring for a sick kitten who was attacked by a raccoon. EM20010099 1
0179570 12/28/2001 TX 8.5 8 F 12/03/2001 An 8 year old female experienced fever on 1/12/01 after receiving RabAvert for post-exposure prophylaxis. The pt was bitten by a stray cat and the cat was not found. She received human rabies immune globulin and the 1st dose of RabAvert on day 0, 1/9/01, with no adverse events. By day 3, 1/12/01, the pt had a fever of 100F, probably from bronchitis. She was given her 2nd dose of RabAvert. That night, her fever rose to 106F and her mother gave her Advil and Tylenol. The fever subsided, and she recovered on 1/16/01. The pt then received RabAvert on 1/18/01, 1/22/01 and 2/5/01. She is currently taking Cefzil for bronchitis, Albuterol inhaler for chronic asthma and Delsym. No further problems were noted. Y 01/12/2001 01/12/2001 0 PVT OTH Cefzil; albuterol; Rabies Immune Globulin, Human; Delsym Bronchitis Chronic asthma; Allergy to animals, allergic rhinitis; bitten by a stray cat and cat was not found; EM20010137 1
0179571 12/28/2001 MD 45.0 44 F 12/03/2001 A 45 year old female experienced muscle ache, tiredness, headache, sweating and chills on 1/27/01 following vaccination with RabAvert for pre-exposure prophylaxis for potential future exposure to rabid animals at work. The subject received her 1st dose of RabAvert on 1/19/01 without experiencing any significant adverse events. At approx. 03:00 on 1/27/01, after the 2nd RabAvert vaccination on 1/26/01, the pt experienced generalized muscle aches, feeling tired, headache, sweating and chills. She treated herself with ibuprofen for 2 days. She recovered on 1/30/01. The pt received her 3rd vaccination on 2/9/01 and experienced no adverse events. Y 01/26/2001 01/27/2001 1 PUB PUB Multivitamins UNK EM20010252 1
0179572 12/28/2001 MD 29.0 29 F 12/03/2001 A 29 year old female experienced generalized muscle aches, tiredness, headaches, sweating, chills and swollen lymph glands of 1/27/01, following vaccination with RabAvert for pre-exposure prophylaxis for potential future exposure to rabid animals at work. The subject received her 1st dose of RabAvert without experiencing any significant adverse events on 1/19/01. Twelve hours after the 2nd RabAvert vaccination on 1/26/01 at 03:00 AM, the pt experienced generalized muscle aches, feeling tired, headaches, sweating and chills. She also experienced swollen lymph glands in the axillary area of the arm that received the RabAvert injection. The subject received the 3rd RabAvert vaccination on 2/9/01. She recovered from the adverse events. Y 01/26/2001 01/27/2001 1 PUB PUB Multivitamins UNK Em20010253 1
0179573 12/28/2001 MA 46.0 F 12/03/2001 A 45 year old female experienced a severe pruritic rash on 2/19/01 after receiving RabAvert for pre-exposure vaccination on 1/31/01 and 2/7/01. On 2/19/01, after the 2nd RabAvert injection, the pt developed a severe rash on about 90% of her body surface; the rash was on her torso, arms, thighs, buttocks and feet. The rash was red, very itchy, burning, raised and bumpy in some places and smooth in other areas. There were spots the size of a quarter to the size of dinner plates. The pt had no trouble breathing. She was treated with oral Benadryl and Benadryl cream for 1 1/2 weeks, and soaked herself in Aveeno bath. The rash resolved on 3/7/01. Her physician had told her not to receive the 3rd injection because of the rash. The pt had no medical dx and no other medication. She had no known allergies and no changes in soap, lotion, cosmetics, jewelry or clothes. Y 02/07/2001 02/19/2001 12 PVT OTH NONE UNK EM20010332 1
0179574 12/28/2001 1.08 F 12/03/2001 A mother reported that her 13 month old daughter developed a fever following post-exposure rabies vaccination with RabAvert. The child received RabAvert (quantity and route of administration not reported) and HRIG at 17:30 in 8/01 (exact date unk). The child developed a fever of 101F at 03:30, the following morning. The child was treated with Tylenol and the fever resolved in 2 hours. Additional information has been requested. Y 08/01/2001 08/01/2001 0 OTH OTH Rabies Immune Globulin, Human UNK Post-exposure rabies EM20011010 1
0179575 12/28/2001 MD 8.0 M 12/03/2001 An 8 year old male developed a fever and injection site pain following post-exposure RabAvert administration. The pt received rabies immune globulin, human, and RabAvert on day 0 and RabAvert on days 3 and 7. Following the 1st 2 doses of RabAvert, the pt experienced some minor pain at the site of the injection. Approx. 24 hours, after the 3rd dose of RabAvert, the pt developed a fever of 103F. Within 24 hours, the fever subsided. Y Temperature-103F OTH OTH Rabies Immune Globulin, Human UNK EM20011100 1
0179576 12/28/2001 IL 71.0 71 M The pt had a PMH of ITP in 1998 during his adjuvant chemotherapy for colorectal cancer. , treated with IGIV. Two weeks, post vax, he presented with recurrent ITP. The pt complained of bruising. He was treated with WinRho, prednisone and platelet transfusion. He is currently taking 60mg of prednisone. In 17 years of clinical practice, I don't ever recall seeing ITP related to influenza vaccine. Seeing 2 pts in the same week was more than a coincidence for me. I thought this would be of interest to you. Y U 11/05/2001 11/19/2001 14 CBC-nml hemoglobin and hematocrit; platelet count-o OTH OTH Follow-up adjuvant colon cancer 1
0179733 12/29/2001 VT 52.0 52 F 12/29/2001 Patient c/o of painful cardiac palpitations, some SOB, lightheadedness and weakness (mod), which required her to sit and rest about 15 minutes. Y 10/31/2001 10/31/2001 0 PVT PVT HRT None Amoxicillian 1
0179577 12/31/2001 NE 65.0 65 F 12/26/2001 Information has been received from an RN concerning a 65 year old Caucasian female who on 11/9/01 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. There was no illness at the time of vaccination. Subsequently, about 6-8 hours, post vax, the pt developed a fever, weakness, muscle aches, injection site redness and soreness, chills, a rash, a swollen arm and dyspnea. On 11/15/01, the pt was admitted to the hospital. While hospitalized, she was treated with steroids and antibiotics. The pt was discharged on 11/18/01 with a dx of adverse drug reaction and exacerbation of COPD. It was noted that the pt had a visit at the doctor's office since her discharge and all her symptoms had resolved except the dyspnea, which was being treated with portable oxygen that was used at night. Follow up information indicated that the patient recovered in December 2001. As of 2/23/02 she had no complaints of the symptoms. Y Y 3 Y 11/09/2001 11/09/2001 0 PVT PVT UNK COPD; Cleocin allergy WAES01111675 1
0179578 12/31/2001 TN 3.0 3 F 02/06/2002 A mother reported that her 3 year old daughter received injections of Prevnar, Infanrix, IPV and haemophilus influenzae type B conjugate vaccines on 10-DEC-2001 and 1 hour following immunization, developed diarrhea. Later that same evening, she developed fever of 104 degrees F and would not respond to her mother. She was hospitalized that evening and according to the pt's mother, "it was not determined what was wrong with her." As f 13-DEC-2001, her fever and diarrhea had resolved and she was discharged from the hospital. her mother reported that her daughter was "still not acting normal". As of the date of this report, no further information was available. Follow up info received 2/5/02 indicated that the pt reportedly developed fever of 104.7 deg F. Y 3 U 12/10/2001 12/10/2001 0 UNK OTH OTH UNK UNK UNK 9637226 1
0179579 12/31/2001 NV 0.4 0 .5 F 12/27/2001 A physician reported that a 5 month old female received her second dose of Prevnar in May 2001. On 09-NOV-2001 at 11 months of age, the infant developed a fever and viral infection. On 16-NOV-2001, she was seen in an ER where she was diagnosed with meningitis. A lumbar puncture was positive for Streptococcus pneumoniae and the infant was admitted for hospitalization. Additional information received from the same reporter on 20-NOV-2001 indicated that the infant received her second dose of Prevnar along with DTaP, IPV and haemophilus b conjugate vaccines on 23-MAy-2001. Approximately 1 and 1/2 weeks prior to admission, the infant had been diagnosed with bronchitis and treated with an unspecified decongestant. On 16-NOV-2001, she developed a fever of 101.6 and was listless. the infant was seen by a physician who sent the infant directly to the ER. She was treated with vanomycin abd ceftriaxone. On 18-NOV-2001, the infant was examined by a physician who noted that the infant's neck was stiff and unable to flex. Her abdomen was bulging with an enlarged liver and an additional diagnosis of hepatomegaly was made. Information regarding this event has been forwarded to the manufacturer. Follow up information received from the physician on 25-DEC-2001 indicated hat the infant received her second dose of Prevnar, Acae-Imune, Hib-titer and IPV vaccines. The pt recovered. Y Y Y 05/23/2001 11/09/2001 170 LP-positive for streptococcus pneumoniae; CT-nml; WBC-24.3; neutrophils 75.3%; lymphocytes-16.6%; monocytes-7.8%; C-reactive protein-1.3; platelet count-648,000; CSF-white blood cells at "600,000" and proteins at 107. OTH OTH UNK NONE Bronchiolitis; Otitis Media NOS; Sinusitis NOS HQ8671821NOV2001 1
0179580 12/31/2001 TN 64.0 64 M 12/19/2001 On 10/29/2001 Pt received Flu vaccine at approximately 1200. Pt has received flu immunization for many years without incident. Approximately 18 hours post flu vaccine pt has fever. Approximately 24 hours post vaccination pt becomes dizzy and has difficulty walking. Weakness progresses but pt waits until following week to see neurologist. At that office visit pt received Solu-Medrol infusion followed by 1 week of oral prednisone. Exacerbation of MS lasted in totality about 2.5 weeks and did not resolve until completion of oral prednisone. Pt's spouse decided that her husband should not receive the flu shot in the future. Y 10/29/2001 10/30/2001 1 UNK UNK Avonex Multiple sclerosis 1
0179581 12/31/2001 CA 71.0 71 F Fever 102.7 F, runny nose, sore throat, body aches. Had bloody nose 5 days, discontinued 81 mg aspirin per doctor instruction. Severe fatigue and body aches, no appetite, stomach upset. Y 10/31/2001 10/31/2001 0 OTH OTH 1
0179582 12/31/2001 MA 56.0 56 F 12/19/2001 Swollen, red 3.5 by 4 inch induration right arm. U 12/18/2001 12/18/2001 0 PUB PUB NONE NONE MA0106 1
0179583 12/31/2001 MA 53.0 53 M 12/17/2001 Two to three days after flu vaccination case developed bilateral tingling hands and feet, more pronounced when flexing neck. Y U 11/01/2001 11/03/2001 2 MRI cervical-diagnosis lesion C2 demyelinating; MRI brain-negative; Spinal tap pending. PUB PUB Liptor, ASA NONE Seasonal Allergies MA0107 1
0179584 12/31/2001 MA 37.0 36 F 12/06/2001 12/04/2001 5:30 AM woke up with sore neck, puffy eyes; fatigue, achy, nausea, sore throat and later that day complained of chills. Took two Tylenol at 6 AM, noon and 5 PM on 12/04/2001. 12/05/2001 Still with nasal complaints, no sneezing, but neck still sore. Continued 2 Tylenol every 4 hours. Did not call PCP but did see chiropractor for sore neck with relief by Friday 12/07/2001 symptoms were gone. Y 12/03/2001 12/04/2001 1 NONE PUB PUB NONE Sneezing and stuffy NONE MA0108 1
0179585 12/31/2001 MA 53.0 58 F 12/17/2001 1:05 PM Five minutes after injection complained of lightheadedness, slight numb feeling left arm. Reseolved after sitting for 20 minutes (Opened outside door to increased air in room). After 20 minutes pt wanted leave, RN walked outside. Pt states she is going to PCP for complaint of hip pain which she had prior to immunization. At 2 PM at increased numbness in left arm, white lips, swollen lips. Given O2, EKG by physician. No epinephrine given by MD. Resolved on own. Pt also had lobster salad for lunch 1/2 prior to immunization. Never had a problem before. Advised to never have flu vaccine. Telephone call on 12/19/2001, pt feeling much better. Y Y 12/06/2001 12/06/2001 0 NONE PUB PUB Estrogen Left hip pain NONE MA0109 1
0179586 12/31/2001 NY 0.4 0 .5 F 12/20/2001 Index had rash on her genital region which started on 12/05 and lasted for 8 days. Treatment: MD prescribed Nystatin cream, gave to index mother. 12/02/2001 12/05/2001 3 NONE PUB PUB Tylenol and Nystatin cream Cranky, cries NONE 1
0179587 12/31/2001 IL 0.4 0 .4 M 12/06/2001 Signs and symptoms developed 2 hours, post vax. The pt had a temperature of 101F, generalized tremors and shaking. Questionable seizures. The shaking and tremors lasted 5 minutes, then his eyes rolled back, the infant was lethargic and limp with shallow breathing. The mother called 911. The paramedics monitored the infant. The pt received Tylenol alternating with Motrin. The mother called the doctor and was told that if the signs and symptoms continue or persist to call 911 again and go to ER. No further RX necessary. Y Y 10/04/2001 10/04/2001 0 PUB PUB NONE NONE Pt is a twin. IL01051 1
0179588 12/31/2001 AZ 0.5 0 .3 F 12/27/2001 The pt had inconsolable crying for almost 24 hours. Her leg at the site of the vaccination was mottled and blue which resolved. Was seen in ER. Y Y 10/01/2001 10/01/2001 0 PVT OTH 1
0179589 12/31/2001 PA 1.25 1 .3 F 12/24/2001 The pt developed varicella within 10 days of varivax dose. She is still ill. N 12/14/2001 12/22/2001 8 PVT PVT NONE NONE NONE 1
0179590 12/31/2001 NV 73.0 73 F 12/21/2001 The pt had profuse vomiting and diarrhea, simultaneously, every 2 hours (3 times) on the morning following Hep-A shot. Then she had muscle pain in her lower back migrating upward on the right and moving to left kidney, down left leg to buttock, thigh and behind knee to calf. U 10/29/2001 10/30/2001 1 Right hip X-ray shows arthritis in the right hip; CXR PUB OTH NONE NONE NONE 1
0179591 12/31/2001 TX 0.3 0 .4 F 12/07/2001 The pt was staring, unresponsive and extremely pale X 10 minutes. After 5 hours, seemed to be back to normal. Y 11/12/2001 11/12/2001 0 NONE PVT PVT NONE NONE 1
0179592 12/31/2001 TX 20.0 20 F 10/24/2001 The pt developed a fever of 103F, generalized aches and headaches after the 3rd rabies vaccine. She went to ER. Y Y 10/23/2001 10/23/2001 0 OTH PVT NONE 7 days after onset of pneumonia (recovered) 1
0179593 12/31/2001 TX 1.0 1 .0 M 12/12/2001 Redness, swelling, warm to touch. Cellulitis to right thigh. Keflex 200 mg QID for 7 days. Y 12/11/2001 12/12/2001 1 PVT UNK NONE NONE NONE 1
0179594 12/31/2001 TX 16 M 12/12/2001 School nurse reports pt has 1", 1/4" raised cyst like lump on wrist. Pt states occurred after IPV injection. No redness or tenderness. Y 12/11/2001 12/12/2001 1 PUB PUB NONE NONE NONE TX01180 1
0179595 12/31/2001 TX 3.0 3 M 12/13/2001 Mother states child woke up shaking with fever of 103. Continued to shake with teeth chattering, then was very listless and hard to awaken. She gave Tylenol, called MD office told her to give Tylenol and Motrin together. Child no better, still had fever of > 103. told mother to take to MD or go to ER. Y 12/11/2001 12/12/2001 1 PUB PUB NONE NONE NONE TX01181 1
0179596 12/31/2001 MA 60.0 60 F 12/10/2001 Severe local reaction with cellulitis right deltoid area down to elbow then below wrist for 4 days. Treatment: Augmentin 875 PO BID and Zyrtec 1 for 3 days QID. Y Y 12/04/2001 12/04/2001 0 PVT PUB Premarin; Liptor; Zestril; Prilosec Hypertension; hyperlipidemia; GERD 1
0179597 12/31/2001 IA 55.0 55 F 11/29/2001 Right arm red, swollen and itchy. Y Y 10/30/2001 10/30/2001 0 PUB PVT NONE NONE NONE IL01052 1
0179598 12/31/2001 WY 62.0 62 F 12/10/2001 Fever for 3 days, severe upper right arm pain, cough, headache, edema of right axilla area 6 days post injection. Y 11/29/2001 11/30/2001 1 PVT PVT NONE PCN-rash and codeine "wild" 1
0179599 12/31/2001 IA 25.0 25 F 12/21/2001 Dizziness, fever, nausea, vomiting, bad swelling of hands, feet and face. Swelling is intermittent. Nausea over 7 days. Episodes of blurred vision, hands shaky. Y 12/10/2001 12/15/2001 5 NONE OTH OTH Darvocet and ibuprofen NONE NONE 1
0179600 12/31/2001 PA 3.0 1 .0 M 12/24/2001 Broke out with 20-30 chicken pox 12/21/2001. Y 04/09/1999 12/21/2001 987 UNK UNK 1
0179601 12/31/2001 SC 4.0 4 F 12/22/2001 Y 12/19/2001 12/21/2001 2 PVT PUB NONE NONE NONE 1
0179602 12/31/2001 NC 2.0 1 .2 M 12/20/2001 aug-patient could not stand/walk well screaming and very clingy from morning to bedtime. Stopped speaking immediately. Began to not listen/ pay attention. Lost muscle tone. Y N 07/17/2000 07/17/2000 0 MIL MIL ear infection/cold ear infection/cold 1
0179604 12/31/2001 CA 0.2 0 .2 M 12/27/2001 It was reported that a 2 month old male pt received IPOL vaccination on 18-JAN-2001. On 31-JAN-2001 the pt died. No specifics were provided. Further information is requested. COD as per autopsy report was asphyxia due to aspiration of foreign object Y 01/31/2001 N 01/18/2001 01/31/2001 13 OTH OTH U2001013110 1