Received Sep 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (HEPLISAV-B) | DYNAVAX TECHNOLOGIES CORPORATION | 2 | — | — |
Had Complete ENGERIX-B Series and Complete HEPLISAV-B Series and is a Non-Responder to Hepatitis B Vaccines; Initial report received on 25-Aug-2025. A nurse reported that a patient received the complete HEPLISAV-B (hepatitis B vaccine) series after receiving the complete ENGERIX-B for hepatitis B immunization but continued to be a non-responder to the hepatitis B vaccines. No medical history or concomitant medications were reported. On an unknown date, the patient completed the ENGERIX-B hepatitis B vaccine series (lot numbers, expiration dates, NDC numbers, route, and sites not available). On an unknown date, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot number, expiration date, NDC number, route, and site not available)]. On an unknown date, the patient received dose 2 of a hepatitis B vaccine [HEPLISAV-B (lot number, expiration date, NDC number, route, and site not available)]. On an unknown date, after receiving the complete HEPLISAV-B series, the patient was noted to be a non-responder to the hepatitis B vaccines. No additional information was reported. Company Comment: The company assessed the event as non-serious. The event is not immunologically confirmed due to lack of information on dosing and serological marker.; Sender's Comments: The company assessed the event as non-serious. The event is not immunologically confirmed due to lack of information on dosing and serological marker.
Engerix b