Received Oct 29, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (AREXVY) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 72742 | — |
Drug Exposure During Pregnancy; Arexvy was given to a pregnant woman; Arexvy was given to a pregnant woman; Arexvy instead of Abrysvo; 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 29-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 72742, expiry date 12-DEC-2026) for prophylaxis. Co-suspect products included RSV vaccine prot. subunit PreF 2v (Abrysvo) for prophylaxis. On 24-SEP-2025, the patient received Arexvy. The patient did not receive Abrysvo. On 24-SEP-2025, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: Arexvy was given to a pregnant woman) and wrong vaccine administered (Verbatim: Arexvy instead of Abrysvo). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: Drug Exposure During Pregnancy) and drug use in unapproved population (Verbatim: Arexvy was given to a pregnant woman). The outcome of the vaccine exposure during pregnancy, drug use in unapproved population, inappropriate age at vaccine administration and wrong vaccine administered were not applicable. Pregnancy exposure: Pregnancy Exposure (Arexvy): To mother in third trimester Pregnancy Exposure (Abrysvo): Trimester unknown Estimated Delivery/Due date: 17-NOV-2025 Pregnancy Outcome: Pregnancy was ongoing Additional Information: GSK Receipt Date: 22-OCT-2025 A licensed practical nurse reported that a pregnant patient was inadvertently administered Arexvy instead of the intended Abrysvo vaccine.; Sender's Comments: US-GSK-US2025137785:SAME REPORTER US-GSK-US2025137784:SAME REPORTER US-GSK-US2025137800:SAME REPORTER US-GSK-US2025137805:SAME REPORTER US-GSK-US2025137807:SAME REPORTER