Received May 16, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (HEPLISAV-B) | DYNAVAX TECHNOLOGIES CORPORATION | 1 | 945658 | IM / LA |
Received ENGERIX-B as second dose; 17 Year Old Patient Received Heplisav-B; Initial report received on 29-Apr-2025. A physician in the US (PA) reported that a 17-year-old female received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization. No medical history or concomitant medications were reported. On 21-Mar-2025, the patient received dose 1 of a hepatitis B vaccine HEPLISAV-B (lot number 945658, expiration date 31-Jan-2027, and NDC number 43528-003-01) intramuscularly in the left deltoid. After the vaccine was administered, the staff discovered the product was not approved in patients of her age. In Apr-2025, approximately one month after receiving HEPLISAV-B, the patient received dose 2 of a hepatitis B vaccine [ENGERIX-B (lot number, expiration date, route, and site not provided)] that had expired. On an unknown date, the patient had unspecified bloodwork performed which showed no immunity from her childhood vaccines. The patient's college noted that her childhood vaccine was "given too early." No adverse effects 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.
Engerix b