Question:

How do I report something to the FDA? My doctor and I think I might be having an adverse reaction.

Answer: 

In the rare case that you have an adverse reaction to the COVID-19 vaccine, there are multiple ways to contact the FDA. While the FDA does not always investigate individual reports, it is certainly worthwhile to file a report describing what happened to you. 

The FDA keeps an eye on the adverse reporting system.  If they see several reports of a very serious complication, they might act very quickly.  In other situations, where it is more difficult to know whether the problems being reported are actually caused by the vaccine, drug, or medical device, the FDA often analyzes trends over time.  That’s why it’s important to report your experience.  If many patients report similar complications, the FDA might require the manufacturer to conduct a follow-up study. . In the case of Essure, a female sterilization device, patient activists  pressured the FDA to follow up on  thousands of  reports of adverse reactions. Eventually, the FDA forced the manufacturer to conduct a careful study, which validated patients’ self-reported experience.  The company later voluntarily took the device  off the market.

You may report online through MedWatch, the FDA’s program that compiles reports of adverse drug and vaccine reactions. You can also fill out the FDA’s Consumer Reporting Form 3500B, which must be faxed or mailed in. Alternatively, you may call 1-800-FDA-1088 to report by telephone. A health professional can fill out and fax the FDA’s Consumer Reporting Form 3500, which is available here.

For more information about the COVID-19 vaccine, visit our resource page.

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