Vaccine Adverse Event Reporting System (VAERS)
VAERS Information
What is VAERS?

The Vaccine Adverse Event Reporting System (VAERS) is a national vaccine safety surveillance program administered by the FDA and the CDC.

VAERS collects and analyzes information about adverse events that occur after the administration of U.S. licensed vaccines. By monitoring such events, VAERS helps to identify potential safety concerns that otherwise may not come to light before licensure.

A VAERS form is NOT an incident report. It is not used for placing blame or tracking provider errors. Filing a VAERS does not reflect poorly on unit readiness.

How is the MILVAX-VHCN Clinical Services involved with VAERS?

The Military Vaccine Agency - Vaccine Healthcare Centers Network can assist with completion and submission of the VAERS form. The MILVAX-VHCN Clinical Services has a unique relationship with the CDC in that the MILVAX-VHCN Clinical Services reviews all VAERS filed on recipients of military-funded vaccines. Clinicians perform a comprehensive review of the adverse event reported to VAERS. The focus is to provide appropriate clinical management and follow-up to ensure that vaccine safety and protection goals are optimized for all military beneficiaries.

When is a VAERS report mandatory?

VAERS filing is mandatory when:

  • there is a hospitalization associated with a vaccine
  • there is loss of 24 hours of duty due to illness, injury, or reaction temporally associated with a vaccine *
  • the event is on the VAERS reportable events table
  • contamination of a vaccine lot is suspected
  • there is autoinoculation or contact transmission w/ SPV *
  • the patient or provider finds an event unacceptable
  • there is any suspected vaccine-related event

There is no time restriction
Submitter need not prove causality

*Immunization & Chemoprophylaxis instruction (2-10) has recommendations for VAERS submission.

Who can report to VAERS?

Anyone can report to VAERS. The majority of VAERS reports are sent in by vaccine manufacturers, health care providers, vaccine recipients (or their parent/guardians). Vaccine recipients or their parents or guardians are encouraged to seek the help of their health care professional in filling out the VAERS form.

How do I complete a VAERS report?

The VAERS form should be completed to the best of one's knowledge. The following boxes are considered essential and should be completed whenever possible:

  • Box 3: Date of birth
  • Box 4: Age of patient at the time of vaccination
  • Box 7: Narrative description of adverse events, symptoms, etc.
  • Box 8: Determines whether a report is regarded as serious or non-serious, and identifies the most serious reports for 60-day and annual follow-up
  • Box 10: Date of vaccination
  • Box: 11: Adverse event onset
  • Box 13: Names of vaccines given
  • Box 15: Where vaccine was given: *It is critical that military beneficiaries check the Military clinic/hospital box

Each report should be complete, accurate and legible. Pay particular attention to:

  • Dates: All dates should make chronological sense. For example: the vaccine date cannot precede the birth date; the report date cannot precede the vaccine date, etc. Please provide the full month, date and year for all requested dates.
  • Patient name: Verify the patient's first and last names are correct. This assists in the identification of duplicate reports.
  • Reporter information (upper right corner of form): The reporter name and complete mailing address are required. Verification letters and requests for missing or follow-up information are sent to this address.
What method do I use to submit a VAERS report?

Submit the VAERS: Mail, Fax, Telephone, or Internet

How do I submit a military VAERS report?

Check with your local MTF and command for information about local and service-specific reporting requirements.

Should I file a VAERS on all events that occur after vaccinations?

We encourage you to report any reaction following vaccination to VAERS even if you cannot tell whether the vaccine or another product caused it. For a discussion of the difference between common side effects and adverse events, click here.

Why is it important to document and report a Vaccine Adverse Event?

It is important to have an unacceptable adverse event evaluated so that future vaccine use is based on a safety evaluation and consideration of a medical exemption or line of duty determination, such as:

  • Obtaining an Allergy-Immunology consultation.
  • Obtaining MILVAX-VHCN second opinion consults.

In addition, better reporting helps keep vaccines safe for everyone who receives them.