The Vaccine Adverse Event Reporting System (VAERS) is a national early warning system to detect possible safety problems in vaccines used in the United States. VAERS accepts and analyzes reports of adverse events (AEs) after a person has received a vaccination. Anyone can report an adverse event to VAERS. Healthcare professionals are required to report certain adverse events and vaccine manufacturers are required to report all adverse events that come to their attention.
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.
The Vaccine Adverse Event Reporting System (VAERS) is a national early warning system to detect possible safety problems in vaccines used in the United States. VAERS accepts and analyzes reports of adverse events (AEs) after a person has received a vaccination.
Healthcare providers who administer COVID-19 vaccines should report the following to VAERS:
Healthcare providers are also encouraged to report to VAERS any additional clinically significant AEs following vaccination, even if unsure whether vaccination caused the event.
To report an adverse event (including administration errors) after Beyfortus (nirsevimab)*
*Beyfortus (nirsevimab) is not a vaccine. It is a monoclonal antibody given by injection and used in newborns, infants, and young children to protect them from respiratory syncytial virus (RSV). It may be given at the same time that vaccinations are given.
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.