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 frequently reported event can trigger research on that issue.
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 IHD involved with VAERS?
The Immunization Healthcare Division (IHD) can assist with completion and submission of the VAERS form. The IHD has a unique relationship with the CDC in that the IHD 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, a life-threatening event or a permanent disability associated with a vaccine- resulted in time lost from duty (> 1 shift), injury, or reaction temporally associated with a vaccine *
- the event is on the VAERS reportable events table
- contamination of a vaccine lot is suspected
Not mandatory but strongly encouraged:
- there is autoinoculation or contact transmission w/ smallpox vaccination *
- resulted in permanent medical exemptions
- the event is unexpected in nature or severity
- there is any suspected vaccine-related event
There is no time restriction
Submitter need not prove causality
*Paragraph 2-10 of the Joint Regulation (AR 40-562, BUMEDINST 6230.15B, AFI 48-110_IP, CG COMDTINST M6230.4G) Immunizations and Chemoprophylaxis for Prevention of Infectious Disease 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 recipients, health care providers, and vaccine manufacturers. Vaccine recipients or their parent/guardian 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 and as detailed as possible. Patient contact information is essential and please note boxes 27 and 28 for Military and DoD related reports.
The VAERS form contains 5 sections
Information about the patient:
- Patient information (age, date of birth, sex, contact information, medication, health history and pregnancy)
- Date and time of vaccination
- Date and time of adverse event
- Today’s date
Information about the person completing the form and facility where administered.
- Form completed by and contact information
- Facility/Clinic name and type
- Physician’s contact information (if applicable)
Vaccine Information and adverse event description and outcome
- Vaccine information (brand name, dosage)
- Symptoms and outcome of the adverse event(s)
- Medical tests and laboratory results (if applicable)
- Patient recovery and outcome
Additional information
- Other vaccines received within one month of vaccination
- Previous adverse events
- Race and ethnicity
Complete only for U.S. Military or Department of Defense related reports
In addition to active duty service members, Reserve and National Guard members, beneficiaries include: retirees, their families, survivors, certain former spouses, and others who are registered in the Defense Enrollment Eligibility Reporting System (DEERS).
- Status at vaccination (Active Duty, Reserve, National Guard, Beneficiary, Other
- Vaccinated at Military/DoD site
Each report should be complete, and accurate. 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, including spelling. This assists in the identification of duplicate reports.
- Reporter information: The reporter name and complete mailing address are required. Verification letters and requests for missing or follow-up information can be sent to this address.
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 concerning 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 provides a signal to the FDA/CDC that there may be a safety concern for a particular vaccine or vaccine combination that needs a safety evaluation.
- It provides MHS with feedback on vaccine events that result in military exemption or impact line of duty.
- Alerts DHA-IHD on MHS-specific vaccine issues that need special consideration or further research.
Page last updated Sept. 25, 2020