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Report an Adverse Event to VAERS

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:

• Any adverse event listed in the VAERS Table of Reportable Events Following Vaccination that occurs within the specified time period after vaccinations
• An adverse event listed by the vaccine manufacturer as a contraindication to further doses of the vaccine

Healthcare providers are strongly encouraged to report to VAERS:

• Any adverse event that occurs after the administration of a vaccine licensed in the United States, whether it is or is not clear that a vaccine caused the adverse event
• Vaccine administration errors

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.

VAERS Reporting Requirements for COVID-19 Vaccines

As of August 2022, there are four vaccines available to protect against COVID-19 disease:

• Pfizer-BioNTech COVID-19 Vaccine (Comirnaty®)
• Moderna COVID-19 Vaccine (Spikevax®)
• Johnson & Johnson's Janssen COVID-19 Vaccine
• Novavax COVID-19 Vaccine, Adjuvanted

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 to report the following to VAERS:

• Vaccine administration errors, whether or not associated with an adverse event (AE).
• If the incorrect mRNA COVID-19 vaccine product was inadvertently administered for a second dose in a 2-dose series, VAERS reporting is required.
• If a different product from the primary series is inadvertently administered for the additional or booster (third dose), VAERS reporting is required.
• VAERS reporting is not required for the following situations:
• If a mixed series is given intentionally (e.g., due to hypersensitivity to a vaccine ingredient)
• Mixing and matching of booster doses intentionally (as of October 21, 2021, mixing and matching of booster doses is allowed)
• Serious AEs regardless of causality. Serious AEs per FDA are defined as:
• Death
• A life-threatening AE
• Inpatient hospitalization or prolongation of existing hospitalization
• A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions
• A congenital anomaly/birth defect
• An important medical event that based on appropriate medical judgement may jeopardize the individual and may require medical or surgical intervention to prevent one of the outcomes listed above
• Cases of myocarditis after a Pfizer-BioNTech, Moderna, or Novavax vaccine, or Janssen COVID-19 vaccine
• Cases of pericarditis after a Pfizer-BioNTech, Moderna, or Novavax vaccine, or Janssen COVID-19 vaccine
• Cases of Multisystem Inflammatory Syndrome in children and adults
• Cases of COVID-19 that result in hospitalization or death

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.

Also report any additional select 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 as outlined in the Fact Sheet for Healthcare Providers for any approved COVID-19 Vaccine

VAERS Reporting Requirements for Monkeypox vaccines

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:

• Vaccine administration errors, whether or not associated with an adverse event
• Serious* adverse events (irrespective of attribution to vaccination)
• Cases of cardiac events, including myocarditis and pericarditis
• Cases of thromboembolic events and neurovascular events

*Serious adverse events are defined as:

• Death
• A life-threatening AE
• Inpatient hospitalization or prolongation of existing hospitalization
• A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions
• A congenital anomaly/birth defect
• An important medical event that based on appropriate medical judgement may jeopardize the individual and may require medical or surgical intervention to prevent one of the outcomes listed above

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:

1. Intradermally (between the layers of the skin) on the inner aspect of the forearm, and
2. Subcutaneously (under the skin) in the upper arm above the elbow

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.

Two Ways to Submit an Online Report to VAERS

If you need further assistance with reporting to VAERS, please email info@VAERS.org or call 1-800-822-7967.

What happens after a report is submitted

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.

Privacy Protection

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.