Frequently Asked Questions

What is VAERS?

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 200,000 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.

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Who can report to VAERS?

Anyone can report to VAERS. Vaccine recipients or their parents or guardians are encouraged to seek the help of their health care professional in filling out the VAERS form.

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Why should I report to VAERS?

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.

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How do I report to VAERS?

You can submit reports online through a Web reporting system or on a paper VAERS report form. You may use photocopies of the form to submit reports.

You can obtain pre-addressed postage-paid report forms via fax, mail, or e-mail by calling the VAERS Information Line at (800) 822-7967.

Completed paper VAERS forms may be sent via fax to (877) 721-0366 or by mail to-

VAERS
PO Box 1100
Rockville, MD 20849

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What events should I report to VAERS?

You can report any adverse event that occurs after the administration of any vaccine licensed in the United States. You should report adverse events even if you are unsure whether a vaccine caused them. The National Childhood Vaccine Injury Act (NCVIA) requires health care providers to report:

• Any adverse event listed by the vaccine manufacturer as a contraindication to further doses of the vaccine.
• Any adverse event listed in the Vaccine Injury Table that occurs within the specified time period after vaccination.

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How are VAERS reports analyzed?

Data collected on the VAERS form includes information about the patient, the vaccination(s) given, the reported adverse event, and the person reporting the event.

The CDC and FDA require additional information on selected VAERS reports for the public health purpose of helping to ensure the safety of U.S.-licensed vaccines. You or your health care provider may be contacted for follow-up information by VAERS staff after your report is received. These selected reports are followed up by a team of health care professionals to obtain additional information (such as medical records and autopsy reports) to provide as complete a picture of the case as possible. All records sent to VAERS are kept confidential as required by law. The patient's consent is not required to release the medical records to VAERS. If you have questions about how the Health Insurance Portability and Accountability Act of 1996 (HIPAA) applies to VAERS, please visit our VAERS Privacy Policies and Disclaimers section.

The signs, symptoms, and diagnoses provided are assigned codes and affixed to the case for indexing purposes. Information obtained from the original VAERS report, follow-up inquiries, and coding activities are stored in a secure computerized database for analysis. Scanned facsimiles of the original reports are also maintained in a computerized image-base for FDA and CDC vaccine surveillance activities. VAERS data stripped of personal identifiers are available for download and review on the Public Access Data page.

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Are all events reported to VAERS caused by vaccinations?

No. VAERS receives reports of many adverse events that occur after vaccination. Some occur coincidentally following vaccination, while others may be caused by vaccination. Studies help determine if a vaccine really caused an adverse event. Just because an adverse event happened after a person received a vaccine does not mean the vaccine caused the adverse event. Other factors, such as the person's medical history and other medicines the person took near the time of the vaccination, may have caused the adverse event. It is important to remember that many adverse events reported to VAERS may not be caused by vaccines.

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How do I find out if a vaccine adverse event has been reported?

The adverse events reported to VAERS are included in the public data sets. After accepting the terms of use, you can follow the instructions to sort the records by vaccine type, or search for a specific adverse event.

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