FDA Adverse Events Reporting System (FAERS) Public Dashboard
This image shows adverse events (AE) reports received by the FDA from 1999 to 2024. Data shown is as of September 30, 2024.
The report types are as follows:
Direct reports: Voluntarily submitted by consumers and health care professionals directly to the FDA via the MedWatch program
Expedited reports: Submitted by manufacturers and have ≥ 1 AE that is not currently described in the product labeling and that resulted in a serious outcome for the patient
Non-expedited reports: Submitted by manufacturers and do not meet the criteria for expedited reports (including adverse events that are reported as expected, nonserious and unexpected, and nonserious and expected)
Biologic safety reports (BSR): Submitted to the FDA as a separate report type involving vaccines and blood products until 2005
Image from the U.S. Food and Drug Administration (FDA).