The Vaccine Adverse Event Reporting System (VAERS) is a passive reporting system, meaning it relies on individuals to send in reports of their experiences. Anyone can submit a report to VAERS, including parents and patients.
Healthcare providers are required by law to report to VAERS:
Healthcare providers are strongly encouraged to report to VAERS:
Vaccine manufacturers are required to report to VAERS all adverse events that come to their attention.
Online reporting is strongly encouraged. Please report clinically important adverse events that occur after vaccination of adults and children, even if you are not sure whether the vaccine caused the adverse event.
VAERS accepts all reports, including reports of vaccination errors. Guidance on reporting vaccination errors is available if you have additional questions.
As of August 2022, there are four vaccines available to protect against COVID-19 disease:
The reporting requirements for COVID-19 vaccines are the same for those authorized under emergency use (EUA) or approved under Biologics License Application (BLA) by the FDA. Healthcare providers who administer COVID-19 vaccines are required by FDA, and under the provider agreements for the CDC COVID-19 Vaccination Program to report the following to VAERS:
Healthcare providers are encouraged to report to VAERS any additional clinically significant AEs following vaccination, even if they are not sure whether the vaccine caused the event.
Healthcare providers must also report any additional selected AEs and/or any revised safety reporting requirements per FDA's conditions of authorized use of vaccine(s) throughout the duration of any COVID-19 vaccine's Emergency Use Authorization (EUA) or any approved COVID-19 vaccine as outlined in the Fact Sheet for Healthcare Providers.
The vaccination provider must report all serious* adverse events following administration of JYNNEOS or ACAM2000 vaccine and vaccine administration errors to the Vaccine Adverse Event Reporting System (VAERS) by submitting online at https://vaers.hhs.gov/reportevent.html.
The vaccination provider is responsible for mandatory reporting of the following listed events following JYNNEOS or ACAM2000 vaccination to VAERS:
*Serious adverse events are defined as:
Providers are encouraged to also report to VAERS any additional clinically significant AEs following vaccination, even if they are not sure if vaccination caused the event.
As of August 9, 2022, FDA issued an Emergency Use Authorization (EUA) for JYNNEOS monkeypox vaccine. It authorizes the vaccine to be administered in one of two ways:
These are considered routes of vaccination. When submitting a VAERS report, ensure that you document the Route in Section 17 of the VAERS form, by choosing “intradermal” or “subcutaneous” from the selection menu.
Knowingly filing a false VAERS report is a violation of Federal law (18 U.S. Code § 1001) punishable by fine and imprisonment.
Submit a VAERS report online. The report must be completed online and submitted in one sitting and cannot be saved and returned to at a later time. Your information will be erased if you are inactive for 20 minutes; you will receive a warning after 15 minutes.
Download the Writable PDF Form to a computer. Complete the VAERS report offline if you do not have time to complete it all at once. Return to this page to upload the completed Writable PDF form by clicking here.
If you need further assistance with reporting to VAERS, please email info@VAERS.org or call 1-800-822-7967.
What will I need to fill out the report?
Each VAERS report is assigned a VAERS identification number. This number can be used to provide additional information about the report to VAERS, if necessary. VAERS will send the identification number to the reporting individual in a confirmation letter (electronically or by mail, depending on communications preferences listed on the original report).
Other than the confirmation letter, VAERS will only reach out to the reporting individual for additional information if “essential fields” of the VAERS form are not filled out. VAERS will not contact the reporting individual by phone for follow-up. Additional information requests are sent electronically or by mail and will explain what information is missing from the report and how the reporter can update it.
The VAERS program follows up on reports classified as serious by attempting to obtain medical records to better understand the event. These requests for medical records are made directly to health institutions or public health authorities that create and maintain medical records. The medical records are added to the permanent record under the VAERS ID, compliant with privacy standards.
Information identifying the person who received the vaccine and the person who filed the report is not made available to the public. You or your health care provider may be contacted for further information after your report is received.
Information supplied in the online submission form is transmitted securely to VAERS. Visit the VAERS Privacy Policies and Disclaimers section for more information about Secure Sockets Layer and data transmission.
VAERS is primarily concerned with monitoring adverse health events and we encourage reporting of clinically significant adverse health events following vaccination. Using clinical judgment, healthcare professionals can decide whether or not to report a medical error at their own discretion. For example, a healthcare professional may elect to report vaccination errors that do not have an associated adverse health event, especially if they think the vaccination error may pose a safety risk (e.g., administering a live vaccine to an immunocompromised patient) or that the error would be preventable with public health action or education.
Healthcare professionals are encouraged to report any clinically significant adverse event following vaccination to VAERS, even if they are not sure if vaccination caused the event.
Healthcare providers are required to report the following adverse events after COVID-19 vaccination, and other adverse events if later revised by CDC, to VAERS:
Also report any additional select adverse events and/or any revised safety reporting requirements per FDA's conditions of authorized use of vaccine(s) throughout the duration of any COVID-19 Vaccine being authorized under an Emergency Use Authorization (EUA).