Received Oct 1, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (AREXVY) | GLAXOSMITHKLINE BIOLOGICALS | 1 | 35P2C | IM / RA |
| RSV | RSV (AREXVY) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 35P2C | — |
Arexvy was administered to a pregnant patient; age inappropriate; Arexvy was administered to a pregnant patient; 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 34-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 35P2C, expiry date 01-NOV-2025) for prophylaxis. On 03-SEP-2025, the patient received Arexvy. On 03-SEP-2025, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: age inappropriate) and drug use in unapproved population (Verbatim: Arexvy was administered to a pregnant patient). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: Arexvy was administered to a pregnant patient). The outcome of the vaccine exposure during pregnancy, inappropriate age at vaccine administration and drug use in unapproved population were not applicable. Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Estimated Delivery/Due date: 04-OCT-2025 Pregnancy Outcome: Pregnancy was ongoing Additional Information: GSK receipt date: 26-SEP-2025 A registered nurse called in to report that Arexvy was administered to a pregnant patient and would like to know if there was any information on that which led to drug use in unapproved population, vaccine exposure during pregnancy and inappropriate age at vaccine administration.