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Vaccinations: Adverse Event Reporting
Many medical procedures have risks involved; vaccinations are no different and can
cause adverse events depending on the individual. An adverse event is considered, “any possible
side effect of a vaccination,” per the Center for Disease Control and Prevention (2015). A
vaccination adverse event can and should be reported anytime there is an event after a licensed
vaccine is given. This does not mean the vaccine necessarily caused the event or the change in
the health status; however, it should be taken into consideration (VAERS, 2015). The
Vaccination Adverse Event Reporting System (VAERS) (2015) stated, “Health care providers are
required to report any adverse event listed by the manufacturer as a contraindication or any event
in the VAERS Table of Reporting Events Following Vaccinations that occur within the specific
time period.”
Anyone can file a VAERS report including providers, the individual that received the
vaccination, their parents or guardian, or the manufacturers of the vaccine. When filing a VAERS
report the individual involved in the adverse event has to be willing to provide specific
information about the vaccination received, when it was received, onset of the adverse effect, any
current illness or medications, past history of events, and some demographic information (Center
for Disease Control and Prevention, 2015). A report can be submitted online at VAERS.hhs.gov,
by fax, and by mail or email. The reporting form can be downloaded from info@VAERS.org.
Detailed instructions for completing the form and a list of reportable events per medication are
located at VAERS.hhs.gov (VAERS, 2015). Once the report is received it will be entered into a
database and a confirmation letter with an identification number is mailed to the originator.
Serious cases will be followed up within 60 days and again at one year post vaccination. This is
done to check patient status. All the information stored in the database is utilized by the Center
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References
Center for Disease Control and Prevention. (2015). Vaccine Adverse Event Reporting System
(VAERS). Retrieved from http://www.cdc.gov/vaccinesafety/activities/vaers.html
VAERS. (2015). Information for healthcare professionals. Retrieved from
http://vaers.hhs.gov/professionals/index#Guidance1
VAERS. (2015). Report an adverse event. Retrieved from http://vaers.hhs.gov/esub/index
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