Received Jul 18, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (HEPLISAV-B) | DYNAVAX TECHNOLOGIES CORPORATION | 1 | 945660 | IM / LA |
Extra Dose Administered; Gave HEPLISAV-B Series Two Doses 28 Days Apart, Rechecked Titer and He is Non-Reactive; Initial report received on 07-Jul-2025. A nurse reported that a 33-year-old male received three doses of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and had a titer lab test which showed that he is non-reactive. No concomitant medications or medical history was reported. On 07-Apr-2025, the patient received dose 1 of a hepatitis B vaccine HEPLISAV-B (lot number 945660 and expiration date 31-Jan-2027; NDC number not available) intramuscularly in the left deltoid. On 12-May-2025, the patient received dose 2 of a hepatitis B vaccine HEPLISAV-B (lot number 945664 and expiration date 31-Jan-2027; NDC number not available) intramuscularly in the left deltoid. On 24-Jun-2025, 44 days after receiving the second dose of HEPLISAV-B, the patient had a qualitative hepatitis B surface antibody titer test performed. The test result showed non-reactive (not immune to hepatitis B virus infection). On 09-Jul-2025, 59 days after receiving the second dose of HEPLISAV-B, the patient received dose 3 of a hepatitis B vaccine HEPLISAV-B (lot number 946060 and expiration date 05-May-2027; NDC number not available) intramuscularly in the left deltoid. No additional information was reported. Company Comment: The company assessed the events as non-serious. The event of vaccination failure was considered not immunologically confirmed based on the dosing schedule.; Sender's Comments: The company assessed the events as non-serious. The event of vaccination failure was considered not immunologically confirmed based on the dosing schedule.
Test Date: 20250331; Test Name: Hepatitis B Surface Antibody, Qualitative; Test Result: Negative ; Comments: Non Reactive; Test Date: 20250624; Test Name: Hepatitis B Surface Antibody, Qualitative; Test Result: Negative ; Comments: Non Reactive