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Adverse Event Reporting to the Food and Drug Administration (FDA)

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The Food and Drug Administration (FDA) requests voluntary reporting of adverse events that may be related to the use of drugs or other medical devices that it regulates. Adverse events related to the use of vaccines are to be reported to  the Vaccine Adverse Event Reporting System (VAERS), which is co-sponsored by the Centers for Disease Control and Prevention (CDC). All other adverse events are to be reported to MEDWATCH.

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