Tags: Health Topics | vaccine | adverse | immunization

What Is the Vaccine Adverse Event Reporting System?

By    |   Thursday, 04 Jun 2015 10:37 AM

The Vaccine Adverse Event Reporting System (VAERS) is a national vaccine safety and surveillance program that began as a national passive reporting system in 1990.

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VAERS is co-sponsored by the Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA).

According to its website, VAERS has five primary objectives: to detect new or unusual adverse reactions to vaccines, to monitor increases in these reactions, to identify potential patient risk factors for specific reactions, to identify vaccine lots with increased reports of adverse events, and to determine and analyze the safety of newly licensed vaccines. 

The CDC and FDA established VAERS in the wake of the 1986 National Childhood Vaccine Injury Act (NCVIA), which required that all healthcare providers administer vaccine information statements (VIS) to the person or guardian of a person receiving a vaccine, as well as report possible side effects that followed a vaccination, according to the CDC.

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Anyone can file a report, and VAERS encourages all healthcare providers, manufacturers, and vaccine recipients to report any adverse events they encounter or experience.

However, VAERS reminds the filers that not all adverse events and reactions are caused by the vaccines themselves, because some reactions occur after a recent vaccination without being causally related to the vaccination at all.

That said, VAERS seeks for all potentially viable reports to be submitted to them for examination, further research into faulty or contaminated vaccines, and subsequent action. 

The FDA notes that VAERS provides an invaluable tool for post-marketing surveillance and identifying potential and actual safety issues and adverse effects amongst the vaccinated, and the FDF constantly monitors the reports filed through VAERS for patterns and changes.

The monitoring and analyzing processes are quite complex and require intense research as over 30,000 reports are filed annually. Of those reports, roughly 13 percent of them are classified as serious (or associated with disability, hospitalization, illness, or death), although most reported cases (85-90 percent) merely describe mild side effects, such as a fever. 

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The Vaccine Adverse Event Reporting System (VAERS) is a national vaccine safety and surveillance program that began as a national passive reporting system in 1990.
vaccine, adverse, immunization
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2015-37-04
Thursday, 04 Jun 2015 10:37 AM
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