VAERS: What we really know about the reporting of adverse events.

March 5, 2008 by · 1 Comment
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The Vaccine Adverse Event Reporting System (VAERS) is currently the only method of post-licensure surveillance for adverse reactions to vaccines in the United States. VAERS is a passive reporting system that allows physicians and parents to submit reports of potential adverse events post-vaccination. Unlike the mandatory reporting system for vaccine preventable diseases, there is no mandated system for the reporting of adverse events following vaccination. The FDA and CDC utilize VAERS for identifying adverse events associated with licensed vaccines (Chen, Rastogi, & Mullen, et al., 1994). Rosenthal and Chen (1995) note that vaccine trials “have sample sizes that are insufficient to detect rare adverse events” and “are usually carried out in well-defined, homogeneous populations with relatively short follow-up periods which may limit their generalizability (p.1706)”. Therefore, it can be assumed that accurate reporting of adverse events to VAERS is a critical issue in indentifying adverse events that occur in the general population. Unfortunately, current literature suggests that VAERS is, at best, poorly utilized (Rosenthal & Chen, 1995).

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