Received Oct 28, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (AREXVY) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 72742 | — |
Drug Exposure During Pregnancy; wrong vaccine; arexvy administered during pregnancy; This non-serious prospective pregnancy case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 28-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 02-OCT-2025, the patient received Arexvy. On an unknown date, the patient did not receive Abrysvo. On 02-OCT-2025, an unknown time after receiving Arexvy, the patient experienced wrong vaccine administered (Verbatim: wrong vaccine) and product use in unapproved population (Verbatim: arexvy administered during pregnancy). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: Drug Exposure During Pregnancy). The outcome of the wrong vaccine administered, product use in unapproved population and vaccine exposure during pregnancy were not applicable. Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Exposure (Abrysvo): Trimester unknown Estimated Delivery/Due date: 25-NOV-2025 Pregnancy Outcome: Pregnancy was ongoing Additional Information: GSK Receipt Date: 22-OCT-2025 The reporter reported that the pregnant patient received Arexvy instead of Abrysvo. This is 1 of 6 report reported by same reporter.; Sender's Comments: US-GSK-US2025137791:SAME REPORTER US-GSK-US2025137785:SAME REPORTER US-GSK-US2025137784:SAME REPORTER