Received Jul 2, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (HEPLISAV-B) | DYNAVAX TECHNOLOGIES CORPORATION | 3 | — | — |
Patient Was Administered Heplisav-b in Three Doses on 08/22, Again on 06/2024, and Recently on 05/2025; Patient Was Administered Heplisav-b in Three Doses on 08/22, Again on 06/2024, and Recently on 05/2025; Initial report received on 05-Jun-2025. A pharmacist reported that a 48-year-old male received three doses of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization. No medical history or concomitant medications were reported. In Aug-2022, the patient received dose 1 of a hepatitis B vaccine HEPLISAV-B (lot number, expiration date, NDC number, route, and site not provided). In Jun-2024, one year and ten months after receiving the first dose, the patient received dose 2 of a hepatitis B vaccine HEPLISAV-B (lot number, expiration date, NDC number, route, and site not provided). In May-2025, 11 months after receiving the second dose , the patient received dose 3 of a hepatitis B vaccine HEPLISAV-B (lot number, expiration date, NDC number, route, and site not provided). The patient was administered three doses of HEPLISAV-B. The patient reported no side effects or adverse reactions. No additional information was reported. Company Comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.