Received Mar 2, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (AREXVY) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | — |
Arexvy administered to a pregnant patient.; Arexvy administered to a pregnant patient.; This non-serious prospective pregnancy case was reported by a pharmacist via call center representative and described the occurrence of drug use in unapproved population in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. In FEB-2025, the patient received Arexvy. In FEB-2025, an unknown time after receiving Arexvy, the patient experienced drug use in unapproved population (Verbatim: Arexvy administered to a pregnant patient.). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: Arexvy administered to a pregnant patient.). The outcome of the drug use in unapproved population and vaccine exposure during pregnancy were not applicable. Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing Additional Information: GSK Receipt Date: 25-FEB-2026 The pharmacist reported Arexvy was administered to a pregnant patient approximately two weeks ago. The pharmacist stated the office sent down the patient for an RSV vaccine, and the Pharmacist did not realize the age limits per the product label for the Arexvy vaccine. The Arexvy vaccine was the only RSV vaccine available at the pharmacy. The Pharmacist did not have any patient information available. The batch number was not provided upon follow up with the reporter.; Sender's Comments: US-GSK-US2026026688:SAME REPORTER