Received Sep 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (HEPLISAV-B) | DYNAVAX TECHNOLOGIES CORPORATION | 1 | 945664 | IM / LA |
Had One Dose of HEPLISAV-B on 8/29/2025 Another Dose On 8/30/2025; Injection Site Pain; Fatigue; Initial report received on 09-Sep-2025. A pharmacist reported that a patient received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and one day later received another dose of HEPLISAV-B. The patient also experienced injection site pain and fatigue. No medical history or concomitant medications were reported. On 29-Aug-2025, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot number 945664, expiration date 31-Jan-2027, and NDC number 43528-0003-05)] intramuscularly in the left deltoid. On 30-Aug-2025, 1 day after receiving the first dose of HEPLISAV-B, the patient received dose 2 of a hepatitis B vaccine [HEPLISAV-B (lot number 945664, expiration date 31-Jan-2027, and NDC number 43528-0003-05)] intramuscularly in the left deltoid. The patient received the second dose one day after the first dose at a different pharmacy from the first dose. The reporter stated that the patient also experienced injection site pain and fatigue. No other side effects were reported. No other information was available. Company Comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.