VAERS Home

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:

• Vaccination administration errors, whether or not associated with an adverse event
• Severe COVID-19 illness (e.g., resulting in hospitalization)
• Cases of observed Multisystem Inflammatory Syndrome
• Serious adverse events (AEs) regardless of causality. Serious AEs are defined as:
1.  Death;
2.  A life-threatening adverse event;
3.  Inpatient hospitalization or prolongation of existing hospitalization;
4.  Persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions;
5.  A congenital anomaly/birth defect;
6.  Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the patient and may require medical or surgical intervention to prevent one of the outcomes listed above.

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).