Received Apr 30, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | 1 | T5D73 | — |
Engerix-B administration in a pregnant woman; This non-serious prospective pregnancy case was reported by a nurse via call center representative and described the occurrence of vaccine exposure during pregnancy in a female patient who received HBV (Engerix B adult) (batch number T5D73, expiry date 10-APR-2027) for prophylaxis. On 19-FEB-2025, the patient received the 1st dose of Engerix B adult. On an unknown date, an unknown time after receiving Engerix B adult, the patient experienced vaccine exposure during pregnancy (Verbatim: Engerix-B administration in a pregnant woman). The outcome of the vaccine exposure during pregnancy was not applicable. Pregnancy exposure: Pregnancy Exposure (Engerix B adult): To mother in second trimester Pregnancy Outcome: Pregnancy was ongoing This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 22-APR-2025, 23-APR-2025 Nurse wanted to know if it was okay to administer a second dose of Engerix-B to a 20-years-old pregnant patient and what would be the administration schedule for someone with that age. Also, mentioned that she received the first dose being already pregnant with 14 weeks and 5 days on 19-FEB-2025, which led to vaccine exposure during pregnancy.