Received Aug 14, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (HEPLISAV-B) | DYNAVAX TECHNOLOGIES CORPORATION | UNK | — | — |
Family Member is a Non-Responder; Initial report received on 25-Jul-2025. A physician reported that a patient received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and was a non-responder. No medical history or concomitant medications were reported. On an unknown date, the patient received a dose of a hepatitis B vaccine [HEPLISAV-B (lot number, expiration date, NDC number, route, and site not available)]. On an unknown date, after receiving HEPLISAV-B, the patient was identified as a non-responder. The reporter was inquiring if the patient was protected against hepatitis B virus. No other information was reported. Company Comment: The company assessed the event as non-serious. The dosing schedule of Heplisav-B and the serological marker was not reported.; Sender's Comments: The company assessed the event as non-serious. The dosing schedule of Heplisav-B and the serological marker was not reported.