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Call VAERS at
1-800-822-7967
Frequently Asked Questions
About VAERS
- What is VAERS?
- Who can report to VAERS?
- Why should I report to VAERS?
- How do I report to VAERS?
- What events should I report to VAERS?
- How are VAERS reports analyzed?
- Are all events reported to VAERS caused by vaccinations?
- What if I can't tell if a reaction was caused by a vaccine or another medication?
- How do I find out if a vaccine adverse event has been reported to VAERS?
- How can I get information on VAERS?
- Is VAERS involved in the Vaccine Injury Compensation Program?
- Does VAERS provide general vaccine information?
What is VAERS? top
The Vaccine Adverse Event Reporting System (VAERS) is a national vaccine safety surveillance program co-sponsored by the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). VAERS collects and analyzes information from reports of adverse events following immunization. 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 and thereby assists in ensuring that the benefits of vaccines continue to be far greater than the risks.
Who can report to VAERS? top
Anyone can report to VAERS. The majority of VAERS reports are sent in by vaccine manufacturers (42%) and health care providers (30%). The remaining reports are obtained from state immunization programs (12%), vaccine recipients (or their parent/guardians, 7%) and other sources (9%). Vaccine recipients or their parents or guardians are encouraged to seek the help of their health care professional in filling out the VAERS form.
Why should I report to VAERS? top
Each report provides valuable information that is added to the VAERS database. Accurate and complete reporting of post-vaccination events supplies the information needed for evaluation of vaccine safety. The CDC and FDA use VAERS information to ensure the safest strategies of vaccine use and to further reduce the rare risks associated with vaccines.
How do I report to VAERS? top
You should use a VAERS report form to report any adverse event. You can
obtain pre-addressed postage paid report forms by calling VAERS at
1-800-822-7967. You may use photocopies of the form to submit reports.
You may also download printable copies of the VAERS form as well as other
information about the VAERS Program from the following Internet sites:
- The VAERS Web site at http://vaers.hhs.gov/
- The Food and Drug Administration's Web site at http://www.fda.gov/cber/vaers/vaers.htm
- The Centers for Disease Control and Prevention Web site at http://www.cdc.gov/nip/
What events should I report to VAERS? top
VAERS encourages the reporting of any clinically significant adverse event that occurs after the administration of any vaccine licensed in the United States. You should report clinically significant adverse events 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.
A copy of the Reportable Events Table can be obtained by calling VAERS at 1-800-822-7967 or by downloading it from http://vaers.hhs.gov/pubs.htm.
How are VAERS reports analyzed top
Both the CDC and the FDA review data reported to VAERS. The FDA reviews reports to assess whether a reported event is adequately reflected in product labeling, and closely monitors reporting trends for individual vaccine lots. Copies of published reviews are available from VAERS. Many different types of events occur after vaccination. Approximately 85% of the reports describe mild events such as fever, local reactions, episodes of crying or mild irritability, and other less serious experiences. The remaining 15% of the reports reflect serious adverse events involving life-threatening conditions, hospitalization, permanent disability, or death, which may or may not have been truly caused by an immunization.
Are all events reported to VAERS caused by vaccinations? top
No. VAERS receives reports of many events that occur after immunization. Some of these events may occur coincidentally following vaccination, while others may truly be caused by vaccination. Studies help determine if there is more than a temporal (time) association between immunization and adverse events. The fact that an adverse event occurred following immunization is not conclusive evidence that the event was caused by a vaccine. Factors such as medical history and other medications given near the time of the vaccination must be examined to determine if they could have caused the adverse event. It is important to remember that many adverse events reported to VAERS may not be caused by vaccines.
What if I can't tell if a reaction was caused by a vaccine or another medication top
We encourage you to report any reaction following vaccination to VAERS, regardless of whether or not you can tell if the vaccine or another product caused it. Reports sent to the VAERS program that also make reference to non-vaccine pharmaceutical products are shared with MedWatch, the FDA's drug safety surveillance system.
How do I find out if a vaccine adverse event has been reported to VAERS? top
You can request information about adverse events reported to VAERS by faxing requests to (301) 443-1726, or by sending requests to:
Food and Drug Administration
Freedom of Information Staff (HFI-35)
5600 Fishers Lane
Rockville, MD 20857
(301) 827-6500
How can I get information on VAERS? top
There are four ways to obtain information about the VAERS program:
- Send e-mail inquiries to info@vaers.org
- Visit the VAERS Web site at: http://vaers.hhs.gov
- Call the toll-free VAERS information line at (800) 822-7967
- Fax inquiries to the toll-free information fax line at (877) 721-0366
Is VAERS involved in the Vaccine Injury Compensation Program? top
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. 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. For more information call (800) 338-2382, or go to http://www.hrsa.gov/vaccinecompensation/default.htm.
Does VAERS provide general vaccine information? top
No. VAERS concentrates on collecting and analyzing the report data. For general information about vaccines and vaccine safety, immunization schedules for children and adults, publications on vaccine-preventable diseases, and more:
- Call the CDC National Immunization Hotline at:
- (800) 232-2522 (English)
- (800) 232-0233 (Spanish)
- Visit CDC's National Immunization Program Web site at http://www.cdc.gov/nip/.
VAERS Mailing Address:
VAERS
P.O. Box 1100
Rockville, MD 20849-1100
Download a copy of these frequently asked questions (PDF 363K).
Download a copy of the VAERS form (PDF 23K).