Received Dec 20, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (HEPLISAV-B) | DYNAVAX TECHNOLOGIES CORPORATION | 1 | 945657 | IM |
Received First Dose of HEPLISAV-B In September, Has Not Had The Second Dose; Initial report received on 02-Dec-2025. A pharmacist reported that a 41-year-old female received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization on 09-Sep-2025 and has not had the second dose. No medical history or concomitant medications were reported. The patient had no known drug allergy. On 09-Sep-2025, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot number 945657; expiration date, NDC number, and site not available)] intramuscularly. As of 02-Dec-2025, 84 days after receiving the first dose of HEPLISAV-B, the patient has not yet received the second dose. No adverse effects were reported. No other information was available. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.