Received Oct 23, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (HEPLISAV-B) | DYNAVAX TECHNOLOGIES CORPORATION | 1 | — | — |
Missed The Dosing Window For Her 2nd Dose of HEPLISAV-B; Initial report received on 17-Oct-2025. A pharmacist reported that a 23-year-old female received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and missed the dosing window for her second dose of HEPLISAV-B. No medical history or concomitant medications were reported. On 21-Jun-2025, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot number, expiration date, NDC number, route, and site not available)]. On 17-Oct-2025, 119 days after receiving HEPLISAV-B, the patient had missed the dosing window for her second dose of HEPLISAV-B. Over three months have passed since she received the first dose. The reporter noted that the due date for the second dose was late July. No additional information was reported. The outcome was not reported. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.