Received Mar 9, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (AREXVY) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | — |
Vaccine exposure during pregnancy; Inappropriate age at vaccine administration.; Drug prescribed for unapproved population; This non-serious prospective pregnancy case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 32-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. On 24-FEB-2026, the patient received Arexvy. On 24-FEB-2026, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: Inappropriate age at vaccine administration.) and drug use in unapproved population (Verbatim: Drug prescribed for unapproved population). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: Vaccine exposure during pregnancy). The outcome of the inappropriate age at vaccine administration, drug use in unapproved population and vaccine exposure during pregnancy were not applicable. Pregnancy exposure: Pregnancy Exposure (Arexvy): To mother in third trimester Pregnancy Details (Neonate 1): Pregnancy Outcome: Pregnancy was ongoing Delivery Notes: The patient was 32 to 36 weeks pregnant at the time of vaccination. Additional Information: GSK Receipt Date:25-FEB-2026 A pharmacist reported that Arexvy had been administered to a 33-year-old pregnant patient. The patient was 32 to 36 weeks pregnant at the time. The pharmacist stated that the office had sent the patient to the pharmacy for an RSV vaccine, and the pharmacist had not realized the age limitations specified in the Arexvy product label. Arexvy had been the only RSV vaccine available at the pharmacy. The batch number was not provided upon follow- up with the reporter. This case is the linked case of the two cases reported by same reporter.; Sender's Comments: US-GSK-US2026027733:SAME REPORTER