Vaccine Adverse Event Reporting System (VAERS) Questions and Answers
- Defining VAERS
- Questions about Reporting to VAERS
- Possible Outcomes of Reporting to VAERS
- For More Information about VAERS
Defining VAERS
What is VAERS?
VAERS is a national vaccine safety surveillance program created as an outgrowth of the National Childhood Vaccine Injury Act of 1986 (NCVIA) and is administered by the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC). VAERS collects and analyzes data from reports of adverse events following vaccination.
Since 1990, VAERS has received over 123,000 reports, most of which describe mild side effects such as fever. Very rarely, people experience serious adverse events following immunization. By monitoring such events, VAERS helps to identify any important new safety concerns that otherwise may not come to light before licensure.
Questions about Reporting to VAERS
Who can report to VAERS?
Anyone can report to VAERS. VAERS reports are usually submitted by health care providers, vaccine manufacturers, vaccine recipients (or their parents/guardians) and state immunization programs. Patients, parents, and guardians are encouraged to seek the help of a health-care professional in reporting to VAERS.
Why should I report to VAERS?
VAERS is a valuable tool for post-marketing safety surveillance. Each report provides valuable information that is added to the VAERS database. Complete reporting of post-vaccination events supplies public health professionals with the information they need to ensure the safest strategies of vaccine administration.
What events should be reported to VAERS?
VAERS encourages the reporting of any significant adverse event occurring after the administration of any vaccine licensed in the United States. You should report any significant adverse event even if you are unsure whether a vaccine caused the event.
The National Childhood Vaccine Injury Act (NCVIA) requires health care providers to report:
- Any event listed by the vaccine manufacturer as a contraindication to subsequent doses of the vaccine.
- Any event listed in the Reportable Events Table that occurs within the specified time period after vaccination.
The Reportable Events Table specifically outlines the reportable post-vaccination events and the time frames in which they must occur in order to qualify as being reportable. To obtain a copy of the Reportable Events Table, click here or call 1-800-822-7967.
How do I report to VAERS?
Reports may be submitted online at https://vaers.hhs.gov/
You can also download the PDF form and fax to 1-877-721-0366 or mail the completed form to:
VAERS
P.O. Box 1100
Rockville, MD, 20849-1100
If you require assistance with reporting, you can contact VAERS by email at [email protected] or by phone at 1-800-822-7967
I am hearing about false reports being made to VAERS?
As stated on the VAERS report form, “knowingly filing a false VAERS report with the intent to mislead the Department of Health and Human Services is a violation of Federal law (18 U.S. Code § 1001) punishable by fine and imprisonment.”
Possible Outcomes of Reporting to VAERS
How are VAERS reports analyzed?
Analyzing VAERS reports is a complex task. Both FDA and CDC review data reported to VAERS. FDA reviews reports to assess whether a reported event is adequately reflected in the Emergency Use Authorization prescribing information, or product labeling for licensed (approved) vaccines. In addition, FDA closely monitors reporting trends for individual vaccine lots.
Can information reported to VAERS lead to FDA actions?
Based on information reported to VAERS and/or other systems in place to monitor vaccine safety, FDA may undertake a number of regulatory actions. These could include changes to the vaccine labeling, Fact Sheets, communications to the public and healthcare providers, or requiring the manufacturer to conduct additional studies.
Are all events reported to VAERS caused by vaccinations?
No. VAERS reports generally cannot be used to determine if a vaccine caused or contributed to an adverse event or illness. Some events may occur coincidentally after the administration of a vaccine while others may in fact be caused by a vaccine. If a safety signal is found in VAERS, further studies can be conducted in safety systems such as the CDC's Vaccine Safety Datalink (VSD) or the Clinical Immunization Safety Assessment (CISA) project. These systems do not have the same limitations as VAERS and can better assess health risks and possible connections between adverse events and a vaccine. Additional information about VAERS, VSD, and the CISA project are available here.
What if I can't tell if a reaction was caused by a vaccine or another medication?
We encourage you to report any reaction following vaccination to VAERS, even if you cannot tell if the vaccine or another product caused it. Reports sent to the VAERS program that also refer to non-vaccine pharmaceutical products are shared with MedWatch, FDA's drug safety surveillance system.
How will I know if VAERS has received my report?
You will receive a confirmation number electronically - or a VAERS identification number by mail - depending on your method of reporting.
Will I be contacted by VAERS after submitting a report?
You will be contacted by VAERS if follow-up information (e.g., medical records or other medical documentation) is needed. Please be aware that not everyone who submits a report is contacted and there may be a delay of when someone is contacted.
Can I access my VAERS report?
You can access a copy of your report at the CDC VAERS WONDER website by using your VAERS identification number.
You can also contact VAERS at 1-800 822-7967 or [email protected] if you need assistance with access to your report – or have specific questions about your report. Due to the large volume of calls, there may be a delay in speaking with a VAERS representative.
How do I find out if a vaccine adverse event has been reported to VAERS?
The VAERS and CDC WONDER websites allow you to access adverse events reports submitted to VAERS. Please note that a VAERS report does not mean that the vaccine caused the adverse event, only that symptoms occurred after vaccination. De-identified VAERS data are usually available 4-6 weeks after the report is received.
You may submit a Freedom of Information Act (FOIA) request for information not available through VAERS and CDC WONDER.
Food and Drug Administration
Division of Freedom of Information
Office of the Executive Secretariat, OC
5630 Fishers Lane, Room 1035
Rockville, MD 20857
Phone: 301-796-3900
Fax: 301-827-9267
For More Information about VAERS
Is VAERS involved in the Vaccine Injury Compensation Program?
No. The National Childhood Vaccine Injury Act created the Vaccine Injury Compensation Program (VICP) to compensate individuals whose injuries may have been caused by vaccines recommended by the CDC for routine use. VICP is separate from the VAERS program. For more information about VICP go to https://www.hrsa.gov/vaccinecompensation/index.html, or call 1-800-338-2382. Reporting an event to VAERS does not file a claim for compensation to the VICP. A petition must be filed with VICP to start a claim for compensation.
Where can I find more information about electronic reporting to VAERS?
Information concerning regulatory submissions in electronic format for biologics products can be found here.
Are there other systems in place to monitor the safety of vaccines?
Yes, VAERS is not the only system in place to monitor vaccine safety. The U.S. government - in partnership with health systems, academic centers, and private sector partners - uses multiple existing vaccine safety monitoring systems to monitor COVID-19 vaccines in the post-authorization/approval period. These systems include the VSD, Biologics Effectiveness and Safety (BEST) and Medicare claims data.
Further information about VAERS, including the main strengths and limitations, can be found here.