Received Mar 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (AREXVY) | GLAXOSMITHKLINE BIOLOGICALS | 1 | ae435 | IM / LA |
| RSV | RSV (AREXVY) | GLAXOSMITHKLINE BIOLOGICALS | 1 | AE435 | — |
Drug Exposure During Pregnancy; Administration in a pregnant patient; This non-serious prospective pregnancy case was reported by a pharmacist via call center representative and described the occurrence of product use in unapproved population in a 34-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number AE435, expiry date 30-OCT-2025) for prophylaxis. On 10-FEB-2025, the patient received the 1st dose of Arexvy. On 10-FEB-2025, an unknown time after receiving Arexvy, the patient experienced product use in unapproved population (Verbatim: Administration in a pregnant patient). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: Drug Exposure During Pregnancy). The outcome of the product use in unapproved population and vaccine exposure during pregnancy were not applicable. Pregnancy exposure: Gestation time at first exposure (Arexvy): 35 Weeks Pregnancy Exposure (Arexvy): To mother in third trimester Estimated Delivery/Due date: 04-MAR-2025 Pregnancy Outcome: Pregnancy was ongoing Additional Information: GSK Receipt Date: 17-FEB-2025 The patient who was 35 weeks pregnant, received a dose of Arexvy, which led to product use in unapproved population and vaccine exposure during pregnancy.