The Vaccine Adverse Event Reporting System (VAERS) is a national early warning system to detect possible safety problems in U.S. licensed vaccines. VAERS is co-managed by the Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA). VAERS accepts and analyzes reports of adverse events (possible side effects) following vaccination.
VAERS is not designed to detect if a vaccine caused an adverse event, but it can identify unusual or unexpected patterns of reporting that might indicate possible safety problems requiring a closer look.
VAERS is co-administered by the Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA)- agencies of the U.S. Department of Health and Human Services (HHS).
Anyone (including healthcare professionals, patients, parents, caregivers, and others) can report to VAERS.
Each report of an adverse event provides valuable information that is added to the VAERS database. VAERS serves as an early warning system to detect possible safety problems in U.S. licensed vaccines. Accurate, complete, and timely reporting of post-vaccination health issues provides important information for vaccine safety monitoring and research.
Patient identity is kept confidential. VAERS complies with all U.S. Government security standards and protections concerning health information.
We encourage you to report any clinically important medical event or health problem that occurs after vaccination. Report the adverse event even if you are not sure if it was a result of vaccination. Healthcare professionals are required by law to report certain adverse events.
Yes. If you provide your contact information when you submit a VAERS report, you will receive a confirmation number electronically or a VAERS identification number by mail, depending on your method of reporting. This serves as confirmation that your report was received.
If you have your VAERS identification number, you can access a copy of your report at the CDC VAERS WONDER website. For help getting your report, contact VAERS at (800) 822-7967 or email@example.com. If you want information beyond what's available on CDC WONDER, contact FDA and possibly submit a Freedom of Information Act (FOIA) request.
Food and Drug Administration
Division of Freedom of Information
Office of the Executive Secretariat, OC
5630 Fishers Lane, Room 1035
Rockville, MD 20857
You will be contacted by VAERS if follow-up information (i.e., medical records or other medical documentation) is needed. All follow-up information should be faxed to 877-721-0366 or submitted online by auto upload on the VAERS website. Be sure to include your E-number or VAERS identification number with the follow-up. To protect information security and confidentiality, do not mail or e-mail medical records or other medical information.
You may also provide follow-up information in response to a VAERS acknowledgment or follow-up letter you may receive. If you have questions about how the Health Insurance Portability and Accountability Act of 1996 (HIPAA) applies to VAERS, please visit our VAERS Privacy Policies and Disclaimers section.
No. VAERS accepts reports of adverse events following vaccination without judging the cause or seriousness of the event. Some adverse events might be caused by vaccination and others might be coincidental and not related to vaccination. Just because an adverse event happened after a person received a vaccine does not mean the vaccine caused the adverse event. VAERS is not designed to determine if a vaccine caused an adverse event, but it is good at detecting unusual or unexpected patterns of reporting that might indicate possible safety problems that need a closer look.
No. Please contact your doctor or healthcare professional to discuss the specifics of your case. Healthcare professionals can request a clinical consultation for particularly complex individual patient cases by contacting the CDC's Clinical Immunization Safety Assessment (CISA) Project. For information on CISA consults, visit http://www.cdc.gov/vaccinesafety/activities/cisa/cisa-evaluation.html.
No. The Vaccine Injury Compensation Program (VICP) is a separate program from VAERS and is administered by the Health Resources and Services Administration (HRSA). Reporting an adverse event to VAERS does not constitute filing a claim with the VICP. For more information about the VICP, call (800) 338-2382 or visit the VICP Web site.