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We already learned about FAERS for drugs, but what about vaccines? You guessed it, vaccine adverse reactions are reported to the Vaccine Adverse Event Reporting System (VAERS). Per HHS, it is designed to be a national early warning system to detect possible safety problems in U.S. licensed vaccines.
Yes, VAERS accepts reports from anyone. Patients, parents, caregivers, and healthcare providers are encouraged to report adverse reactions. Healthcare providers are required to report only certain adverse reactions that occur within a specified period of time. They are not required to report vaccine administration errors (only strongly encouraged).
Most discussions surrounding VAERS is that any reaction can be reported even if it has nothing to do with a vaccine. Some viral social media posts implied that VAERS was full of false reports. However, this warning is on the bottom of the virtual VAERS submission:
Also, according to the FDA:
So what happens with VAERS reports? From the previous source, the FDA may take action such as changes to the vaccine labeling/fact sheets, communications to the public and healthcare providers, or requiring the manufacturer to conduct additional studies.
Wondering if a vaccine you are researching has VAERS reports?
Here is the link to CDC WONDER. Be sure to read the steps + watch the video to learn how to operate this database.
There are limitations to VAERS. One limitation as demonstrated above is that it is a passive reporting system. This means it relies upon patients + healthcare professionals to report adverse reactions. The federal government identified this limitation and discovered most reactions are underreported. Head to the next lesson to learn more!