Received Jul 23, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (HEPLISAV-B) | DYNAVAX TECHNOLOGIES CORPORATION | 1 | — | — |
First Dose of HEPLISAV-B in February 2025 Has Not Received Next Dose; Initial report received on 07-Jul-2025. A pharmacist reported that a 58-year-old female received the first dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization in Feb-2023 and has not received another dose yet. No medical history or concomitant medications were reported. In Feb-2023, the patient received dose 1 of a hepatitis B vaccine HEPLISAV-B (lot number, expiration date, NDC number, route, and site not available). On 07-Jul-2025, approximately 2 years and 5 months after receiving the first dose HEPLISAV-B, the reporter contacted medical information to inquire if the HEPLISAV-B series needed to be restarted. No adverse reactions were reported. 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.