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U.S. Department of Health and Human Services

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How does the FDA collect vaccine safety information?

The safety of new vaccines continues to be monitored following licensure in several ways. The Vaccine Adverse Event Reporting System, co-administered by FDA and CDC, is a national system for the collection of all reports of adverse events following vaccination.   Healthcare providers and vaccine manufacturers are required to report adverse events following the administration of vaccines. 

Here are resources to help you answer questions about vaccine safety and reporting:


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