Submitting a Vaccine Adverse Event Reporting System (VAERS) Report and Using VAERS Data

How to report an adverse event to VAERS

• Option 1: Submit a VAERS Report online (preferred).
• Option 2: Download a Writable PDF Form and upload when ready.

Who can report to VAERS

• Patients.
• Parents, guardians or other family members.
• Caregivers.
• Healthcare providers.
• Vaccine manufacturers.
• Anyone else.

CDC and FDA encourage anyone who has (or is made aware of) an adverse event after vaccination to report it to VAERS, even if they are not sure the vaccine caused the problem.

See reporting an adverse event to VAERS for more information. If you need further assistance, please email info@VAERS.org or call 1-800-822-7967.

What to report to VAERS

General public

Any side effect or health problem after vaccination that is concerning to you, including adverse events.

Healthcare providers

• Required:A
  • Any adverse event listed in the VAERS Table of Reportable Events Following Vaccination that occurs within the specified time period after vaccination, including but not limited to serious adverse events.
  • An adverse event listed by the vaccine manufacturer as a contraindication to further doses of the vaccine. This means you should not get any more doses of the vaccine.

• Strongly encouraged:
  • Any adverse event that occurs after the administration of a vaccine licensed in the United States, whether or not it is clear that a vaccine caused the adverse event.
  • Vaccine administration errors.

COVID-19 and mpox vaccines

There are specific reporting requirements for healthcare providers administering COVID-19 and mpox vaccines.

Vaccine manufacturers

All adverse events that come to their attention.

After you submit a VAERS report

1. VAERS staff give each report a unique identification number (ID).
   1. This helps VAERS staff gather and track more information about the report, if needed.
2. After assigning the ID, VAERS staff send a confirmation letter to the person who made the report (electronically or by mail).
3. When a report is classified as serious, VAERS staff take further action by trying to obtain medical records. This helps them gain a better understanding of what happened.
   1. To get these medical records, VAERS staff contact health institutions or public health authorities responsible for maintaining them.
   2. Once obtained, these medical records are added to the record associated with the VAERS ID. All this is done while ensuring compliance with privacy standards.

Please be aware:

• The filing of a VAERS report is helpful for public health and appreciated. The confirmation letter may be the only communication that VAERS staff will have with the person who made the VAERS report.
  • If needed, VAERS staff may contact the person who made the report to ask for missing information and recovery status.
• VAERS staff generally cannot make a determination as to whether a vaccine caused the reported adverse event based on VAERS data alone.

Multiple reports from different sources for the same event

In some cases, VAERS receives multiple reports for the same adverse event. (For example, the person who had the adverse event and their healthcare provider could submit separate reports for the same adverse event.) VAERS scientists review the reports, identify any multiples or follow-up reports, and attach them to the original submission. This review process ensures the same adverse event is not counted more than once, even in cases where there are multiple reports on the same adverse event.

Accessing VAERS data from CDC’s WONDER System

VAERS data (without patient-identifying information) are available to the public online through a system called CDC's VAERS WONDER.

WONDER gives public health professionals, researchers and the general public easy access to a range of helpful information. WONDER supports health promotion and disease prevention by providing timely facts and data for decision-making, program evaluation and resource allocation. It aims to make it easier for public health professionals to find the information they need and for the general public to access specific details from CDC, including VAERS data.

Step-by-step instructions for accessing this data are available for download or in the videos below.

Video sections

• Section 2 – How to Search VAERS Public Data
  
• Section 3 – Strengths and Limitations of VAERS Data
  
• Section 4 – Where to Get More Information