Clinical Immunization Safety Assessment

VAERS once more with science — how to use it and how to abuse it

I have written numerous times about the Vaccine Adverse Event Reporting System (VAERS) because it is the database of choice for the anti-vaccine world to “prove” that a vaccine is dangerous. It is misused even though it does not tell scientists whether a vaccine is harmless or harmful.

Even though I’ve discussed it many times, I’ve usually critiqued VAERS here and there in different ways, so I wanted to write down, in easy-to-consume, bullet points. I love bullet points since if you have a limited amount of time to read through thousands of words, you can find the information you need easily.

So here we go, let’s take a look at the dumpster-diving into the VAERS database.

Do not use VAERS to evaluate vaccine adverse events

The Vaccine Adverse Event Reporting System (VAERS) is one of the systems employed by the US Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) to monitor vaccine safety. VAERS is a post-marketing surveillance program, collecting information about adverse events (including death) that occur after the administration of vaccines to ascertain whether the risk-benefit ratio is high enough to justify the continued use of any particular vaccine.

VAERS, the Vaccine Safety Datalink (VSD), and the Clinical Immunization Safety Assessment Network (CISA) are the major tools used by the CDC and FDA to monitor vaccine safety. These are powerful tools that contradict the trope from anti-vaccine activists that regulatory agencies do not monitor vaccine safety – they do.

This article will review how VAERS works along with its strengths and limitations. However, one thing we will focus on how dumpster diving into the VAERS database without context is a very bad use of statistics.