15. Considerations Regarding the Vaccine Adverse Event Reporting System (VAERS)
The Food and Drug Administration’s Vaccine Adverse Event Reporting System (VAERS) is an imperfect but valuable resource for identifying potential adverse reactions to vaccines. Established through collaboration between the CDC and FDA, VAERS is “a national early warning system to detect possible safety problems in U.S.-licensed vaccines.” According to the CDC it is “especially useful for detecting unusual or unexpected patterns of adverse event reporting that might indicate a possible safety problem with a vaccine.” (https://vaers.hhs.gov/about.html) Even the CDC recognizes that adverse events reported to VAERS represent “only a small fraction of actual adverse events [207]. A widely cited report noted that less than 1% of all vaccine-related adverse events are reported to VAERS [208]. That assertion, though, has no citation so the basis for the claim is unclear. Rose (2021) published a much more sophisticated analysis of VAERS data to offer an estimate of underreporting by a factor of 31 [209]. While it is impossible to determine underreporting with precision, the available evidence is that underreporting very strongly characterizes the VAERS data. The information presented below should be understood in that light.