Received Dec 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (AREXVY) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | — |
Vaccination during pregnancy and now it´s breastfeeding; Vaccination during pregnancy and now it's breastfeeding; This non-serious prospective pregnancy case was reported by a physician via call center representative 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: Vaccination during pregnancy and now it´s breastfeeding) and product use in unapproved population (Verbatim: Vaccination during pregnancy and now it's breastfeeding). The outcome of the vaccine exposure during pregnancy and product use in unapproved population were not applicable. Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing Additional Information: GSK receipt date: 17-DEC-2025 The patient was vaccinated during pregnancy and now breastfeeding the baby. The Medical Doctor-Pediatrician wanted to know if there was any concern with the baby due to mother´s concern on this specific situation. The batch number was not provided upon follow- up with the reporter.; Sender's Comments: US-GSK-US2025162886:SAME REPORTER