Received Oct 22, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (HEPLISAV-B) | DYNAVAX TECHNOLOGIES CORPORATION | 1 | — | — |
Patient Late Getting the Second Dose; Initial report received on 02-Oct-2025. A pharmacist reported that a patient received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and has not received the second dose yet. No medical history or concomitant medications were reported. In Dec-2024, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot number, expiration date, NDC number, route, and site not available)]. On 02-Oct-2025, approximately 305 days after receiving the first dose of HEPLISAV-B, the patient attempted to receive the second dose of HEPLISAV-B. The outcome was not reported. 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.