Received Jul 15, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (HEPLISAV-B) | DYNAVAX TECHNOLOGIES CORPORATION | 2 | — | — |
Patient had Heplisav-B Doses Two Years Apart; Initial report received on 25-Jun-2025. A nurse reported that a 46-year-old male received doses of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization two years apart. No medical history or concomitant medications were reported. On 03-Jul-2023, the patient received dose 1 of a hepatitis B vaccine HEPLISAV-B (lot number, expiration date, NDC number, route, and site not provided). On 11-Jun-2025, 710 days after receiving dose 1 of HEPLISAV-B, the patient received dose 2 of a hepatitis B vaccine HEPLISAV-B (lot number, expiration date, NDC number, route, and site not provided). The reporter declined to provide further information. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.