Received Sep 29, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (HEPLISAV-B) | DYNAVAX TECHNOLOGIES CORPORATION | 2 | — | IM / LA |
Had First Dose 22-Feb-2025, Second Dose Received 11-Sep-2025; Initial report received on 11-Sep-2025. A consumer reported that he, a 28-year-old male, received the second dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization about six months after the first dose. No medical history or concomitant medications were reported. On 22-Feb-2025 the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot #, expiration date, NDC # not reported)] intramuscularly in the left upper arm. On 11-Sep-2025, approximately 6 months after having been vaccinated with dose 1 of HEPLISAV-B, the patient reported that they received dose 2 of HEPLISAV-B (lot # 945664, expiration date, NDC # 43528-0003-05) intramuscularly in the left upper arm. No side 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.