Question: I saw concerning posts on social media that linked the COVID vaccines to death(!) citing data from the vaccine adverse event reporting system.  What’s the story?

Answer: The Vaccine Adverse Event Report System (VAERS) is a passive reporting system; individuals voluntarily submit adverse events by filling out a VAERS report.  Anyone can submit such a report– healthcare providers, patients, family members, and beyond– and reports vary in quality and completeness.  The biggest thing to remember when examining or using VAERS data is that no cause and effect relationship has been established.   When it comes to deaths, FDA requires vaccination providers to report any death or other adverse event after COVID-19 vaccination to VAERS.  Again, reports of death to VAERS following vaccination do not necessarily mean the vaccine caused the death.  To determine whether the association is causal (e.g. whether the death was a result of the vaccine or unrelated), CDC follows up to request additional information and learn more about what happened.  As CDC recently reported, 

Over 167 million doses of COVID-19 vaccines were administered in the United States from December 14, 2020, through April 5, 2021. During this time, VAERS received 2,794 reports of death (0.00167%) among people who received a COVID-19 vaccine. CDC and FDA physicians review each case report of death as soon as notified and CDC requests medical records to further assess reports. A review of available clinical information including death certificates, autopsy, and medical records revealed no evidence that vaccination contributed to patient deaths. CDC and FDA will continue to investigate reports of adverse events, including deaths, reported to VAERS.

Today, you’ll likely be reading a lot about the J&J vaccine pause as CDC and FDA review 6 cases of blood clots.  This is a perfect example of the adverse event monitoring working and of transparency in action.