VAERS Home

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.

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.

For licensed COVID-19 vaccines (Moderna and Pfizer-BioNTech in people ages 12 years and older), 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 or not it is clear that a vaccine caused the adverse event
• Vaccine administration errors, whether or not associated with an adverse event

For COVID-19 vaccines given under an Emergency Use Authorization (EUA), vaccination providers are required to report to VAERS:

• Vaccine administration errors, whether or not associated with an adverse event
• Serious adverse events regardless of causality. Serious adverse events per FDA are defined as:
  • Death
  • A life-threatening adverse event
  • 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 Multisystem Inflammatory Syndrome (MIS) in children and adults
• Cases of myocarditis
• Cases of pericarditis
• Cases of COVID-19 that result in hospitalization or death

Reporting is also encouraged for any other clinically significant adverse event, even if it is uncertain whether the vaccine caused the event.

To report an adverse event (including administration errors) after Beyfortus (nirsevimab)*

• If Beyfortus (nirsevimab) was given at the same visit with one or more vaccinations:
  • Report to VAERS at VAERS - Report an Adverse Event (hhs.gov)

• If Beyfortus (nirsevimab) was given alone with no other vaccinations on the same visit:
  • Report to MedWatch at MedWatch Online Voluntary Reporting Form (fda.gov)

*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:

• Vaccine administration errors whether or not associated with an adverse event(AE)
• 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.