Vaccination providers enrolled in the federal COVID-19 Vaccination Program are responsible for mandatory reporting of the following to the Vaccine Adverse Event Reporting System (VAERS):
- vaccine administration errors whether or not associated with an adverse event,
- serious adverse events (irrespective of attribution to vaccination),
- cases of Multisystem Inflammatory Syndrome (MIS), and
- cases of COVID-19 that result in hospitalization or death.
Complete and submit reports to VAERS online: https://vaers.hhs.gov/reportevent.html. For further assistance with reporting to VAERS, call 1-800-822-7967. The reports should include the words “Novavax COVID-19 Vaccine, Adjuvanted EUA” in the description section of the report.
Alternatively, adverse events in association with a Novavax product can be reported to Novavax Pharmacovigilance at 844-NOVAVAX between 8:00AM-8:00PM ET Monday - Friday or via the Novavax Adverse Event Reporting Form.
Report an Adverse Event