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Frequently Asked Questions

Filing a Report
About VAERS Reports

General Information about VAERS

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 (possible side effects) following vaccination. Since 1990, VAERS has received more than 200,000 reports, most of which describe mild side effects such as fever. Very rarely, people experience serious adverse events. By monitoring these events, VAERS helps identify new safety concerns, and helps make sure the benefits of vaccines continue to be far greater than the risks. VAERS data are monitored to-

  • Detect new, unusual, or rare vaccine adverse events
  • Monitor increases in known adverse events
  • Identify potential patient risk factors for particular types of adverse events
  • Identify vaccine lots with increased numbers or types of reported adverse events
  • Assess the safety of newly licensed vaccines

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Who reports to VAERS?

Anyone can file a VAERS report, including health care providers, manufacturers, and vaccine recipients. The majority of VAERS reports are sent in by vaccine manufacturers (37%) and health care providers (36%). The remaining reports are obtained from state immunization programs (10%), vaccine recipients (or their parent/guardians, 7%) and other sources (10%). Vaccine recipients or their parents or guardians are encouraged to seek the help of their health care professional in filling out the VAERS form. 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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What can be reported to VAERS?

VAERS seeks reports of any clinically significant medical event that occurs after vaccination, even if the reporter cannot be certain that the event was caused by the vaccine. CDC/ISO and FDA review adverse reports; VAERS has identified important signals that after further research resulted in changes to vaccine recommendations. 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 adverse events even if you are unsure whether a vaccine caused the event. 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.

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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 adverse events supplies the information needed for evaluation of vaccine safety. CDC and FDA use VAERS information to ensure the safest strategies of vaccine use, and to further reduce the rare risks associated with vaccines.

 

Are VAERS reports kept confidential?

VAERS is required to meet the highest Government security standards for using confidential patient medical records. Individual identifiers are removed from all data posted on our website.
VAERS Privacy Policies and Disclaimers

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How do I Report to VAERS?

You can submit reports online through our 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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Which adverse events should I report to VAERS?

We encourage you to 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 VAERS Table of Reportable Events Following Vaccination that occurs within the specified time period after vaccination.

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Will I receive confirmation that the report I filed was received?

Yes. If you file a report online, you will receive a confirmation number, called an "E-number," automatically. If you file a paper report, you will receive your case number and VAERS identification number by mail within a few days.

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How can I get a copy of my report?

You can get a copy of a report you filed by calling the VAERS Information Line at (800) 822-7967.

If you would like a copy of a report filed by someone else you may ask the person who filed the report to give you a copy, or contact FDA's Freedom of Information Office, which charges a fee for copying the report. All identifying information is removed from the report. For more information, contact the Freedom of Information Office at the following address:

Food and Drug Administration

Office of Shared Services

Division of Freedom of Information

Office of Public Information and Library Services

12420 Parklawn Drive ELEM-1029

Rockville, MD  20857

Phone: 301-796-3900

Fax: 301-827-9267

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How do I provide follow-up information for a case?

You may provide additional information about a report you filed via fax, mail, or telephone (by calling our Information Line at (800) 822-7967). Be sure to include your E-number or VAERS identification number. We do not recommend you send e-mail, as the confidentiality of your information can not be assured.

You may also provide follow-up information in response to a VAERS acknowledgment or follow-up letter you may receive. 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.

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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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How are VAERS reports followed up?

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.

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Are all adverse events reported to VAERS caused by vaccines?

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.  Although VAERS can rarely provide definitive evidence of causal associations between vaccines and particular risks, its unique role as a national spontaneous reporting system enables the early detection of signals that can then be more rigorously investigated.

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How Do I find out what adverse events have been reported to VAERS?

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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Which government agencies manage VAERS?

VAERS is a national passive reporting system co-managed by the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) -- agencies of the U.S. Department of Health and Human Services.

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Does VAERS Provide Medical Advice?

No. Please contact a health care provider to discuss the specifics of your case.

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Is VAERS Involved in the Vaccine Injury Compensation Program?

No. The Vaccine Injury Compensation Program (VICP), which compensates people whose injuries may have been caused by vaccines recommended by CDC for routine use in children, is administered by the Health Resources and Services Administration. The VICP is separate from the VAERS program, and reporting an event to VAERS does not file a claim for compensation to the VICP.

For more information about the VICP, call (800) 338-2382 or visit the VICP Web site.

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Is there a compensation program for individuals who are injured by the H1N1 vaccine? 

Yes, the Countermeasures Injury Compensation Program (CICP) is a separate Federal government program directed to compensate certain individuals seriously injured by countermeasures covered, such as the pandemic 2009 H1N1 influenza, smallpox, and anthrax vaccines, under declarations issued by the Secretary of the U.S. Department of Health and Human Services.  Information on the CICP can be obtained by visiting their Website at http://www.hrsa.gov/cicp/ or calling (855) 266-2427 (855-266-CICP) . Please be aware that reporting an event to VAERS does not constitute filing for compensation with the CICP.

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Does VAERS provide general vaccine information?

No. VAERS only collects and analyzes adverse event reports. For general information about vaccine safety, visit CDC's Vaccine Safety Web site. For information about specific vaccines, immunization schedules, publications on vaccine-preventable diseases, and more, visit CDC's Vaccines and Immunizations Web site or call the CDC INFO Contact Center Information Line at (800) 232-4636.

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Where can more information about VAERS be found?

You can get more information about VAERS by:

  • Sending e-mail to info@vaers.org
  • Calling the toll-free VAERS Information Line at (800) 822-7967
  • Faxing inquiries to the toll-free fax line at (877) 721-0366
  • Visiting the Food and Drug Administration
  • Visiting the Centers for Disease Control and Prevention

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