A review of the Vaccine Adverse Event Reporting System database.

The Vaccine Adverse Event Reporting System (VAERS) is an epidemiological database that has been maintained by the FDA and Centers for Disease Control and Prevention (CDC) since 1990. Authors from the National Immunization Programme of the CDC have previously described an epidemiological technique to make qualitative and quantitative measurement in the VAERS database. Application of this technique by ourselves (with further refinements and additions) have resulted in numerous publications showing the VAERS database has good positive predictive value in evaluating vaccine safety concerns that are compatible with observations by many other authors who have analysed different databases. In conclusion, VAERS studies will be particularly critical in the evaluation of the safety of many new or radically changed vaccines expected to be introduced in the relative near future.