Received Oct 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (HEPLISAV-B) | DYNAVAX TECHNOLOGIES CORPORATION | 2 | — | — |
Patient Administered Both 1st and 2nd Dose of HEPLISAV-B and She is 17 Years Old; First Dose 12AUG2025 Second Dose 17Sep2025; Initial report received on 17-Sep-2025. A nurse reported that a 17-year-old female (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization. No medical history or concomitant medications were reported. On 12-Aug-2025, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot, expiration date, NDC #, site and route not reported)]. On 17-Sep-2025, 36 days after having been vaccinated with the first dose of HEPLISAV-B, the patient received the second dose(lot, expiration date, NDC #, site and route not reported). The patient was 17 years old at the time of administration. No adverse reactions were reported. No additional information was reported. Company Comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.