Received Apr 22, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (AREXVY) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | — |
Administration of Arexvy in pregnant patient; Administration of Arexvy in pregnant patient; This non-serious prospective pregnancy case was reported by a pharmacist via call center representative and described the occurrence of vaccine exposure during pregnancy in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. On 14-APR-2025, the patient received Arexvy. On 14-APR-2025, an unknown time after receiving Arexvy, the patient experienced drug use in unapproved population (Verbatim: Administration of Arexvy in pregnant patient). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: Administration of Arexvy in pregnant patient). The outcome of the vaccine exposure during pregnancy and drug use in unapproved population were not applicable. Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing Additional Information: GSK Receipt Date: 14-APR-2025 The supervisor reported that a pregnant women received Arexvy by error on 4/14/2025, which led to drug used in unapproved population and vaccine exposure during pregnancy. This case is linked with US2025AMR046693, reported by same reporter.; Sender's Comments: US-GSK-US2025AMR046693: