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A decade with the vaccine reporting system
Pharmacists play an important role in reporting any kind of adverse reaction to a medication, and vaccines are no exception.
The importance of post-marketing surveillance is undisputed. Even large clinical trials of > 10,000 subjects are inadequate to reveal very rare but often serious adverse events of a drug. In addition, subjects in controlled clinical trials are in very controlled environments. Once a drug is approved and administered to the general population, however, recipients are of vastly divergent demographics, medical histories, medical problems, and concomitant medications. Often, rare side effects do not appear in patients until a drug is administered to a diverse population. It is important then that adverse events be reported in order to further evaluate the safety of a drug.
In 1990, the U.S. Department of Health and Human Services established the Vaccine Adverse Event Reporting System (VAERS). The FDA and Centers for Disease Control and Prevention work together in accepting all VAERS reports.
VAERS is a passive surveillance system for monitoring vaccine safety. All reports of adverse events associated with vaccines — whether submitted by health care professionals, vaccine manufacturers, or those receiving vaccines — end up in the VAERS database. The final destination of those reports is with the VAERS database, whether originally submitted to local or state health authorities, manufacturers, or directly to VAERS.