Janssen (Johnson & Johnson) COVID-19 Vaccine

Janssen COVID-19 Vaccine is authorized for adults ages 18 years and older in certain limited situations due to safety considerations. For guidance on respective record review, scheduling and administration of Janssen vaccine see Interim Clinical Considerations for Use of COVID-19 Vaccines: Appendices, References, and Previous Updates | CDC

Report Adverse Events

Adverse events that occur in a recipient after COVID-19 vaccination are required to be reported to the Vaccine Adverse Event Reporting System (VAERS). FDA requires vaccination providers to report vaccine administration errors, serious adverse events, cases of multisystem inflammatory syndrome, and cases of COVID-19 that result in hospitalization or death after administration of COVID-19 vaccine under an EUA. Reporting is encouraged for other clinically significant adverse events, even if it is not clear that a vaccine caused the adverse event. Complete and submit reports to VAERS online.

For further assistance with reporting to VAERS, call 1-800-822-7967.

Page last reviewed: August 16, 2022