Received Aug 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (AREXVY) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | — |
Arexvy given to pregnant women; Arexvy given to pregnant women; This non-serious prospective pregnancy case was reported by a pharmacist via sales rep and described the occurrence of vaccine exposure during pregnancy in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced vaccine exposure during pregnancy (Verbatim: Arexvy given to pregnant women) and product use in unapproved population (Verbatim: Arexvy given to pregnant women). The outcome of the vaccine exposure during pregnancy and product use in unapproved population were not applicable. Pregnancy Outcome: Pregnancy was ongoing Additional Information: GSK Receipt Date: 22-JUL-2025 The pharmacist reported that while attending the meeting, the presenter mentioned that several pregnant women had been given Arexvy which led to drug used in unapproved population and vaccine exposure during pregnancy. It was asked to remember that the one with the x should not be used in pregnancy.