Received Mar 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (HEPLISAV-B) | DYNAVAX TECHNOLOGIES CORPORATION | 1 | 944917 | IM / LA |
The 2nd Dose of HEPLISAV-B was Confirmed to be Missed; Initial report received on 20-Feb-2025. A pharmacist reported that a 43-year-old male (race, ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization but has not received the second dose yet. No medical history or concomitant vaccines were reported. On 24-Sep-2024, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot # 43528-003-05, expiration date 16-Nov-2026, NDC # 43528-003-05)] intramuscularly in the left arm. At the time of the report, the patient has not received the second dose. It was confirmed to be missed. Additional information was not provided. Company Comment: ? The company assessed the event as non-serious.; Sender's Comments: ? The company assessed the event as non-serious.