Received Oct 7, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (AREXVY) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | — |
Administered arexvy to the pregnant patient; Administered arexvy to the pregnant patient; This non-serious prospective pregnancy case was reported by a nurse 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: Administered arexvy to the pregnant patient) and product use in unapproved population (Verbatim: Administered arexvy to the pregnant patient). 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: 22-SEP-2025 The patient had visited one of the organization's clinics to receive an RSV vaccine during pregnancy. The site had Arexvy in stock and administered it to the pregnant patient, although the specific week of pregnancy was unknown. Upon realizing the error, the treatment site contacted both the patient and the vaccine adverse event reporting system (VAERS). As of the date of reporting, the patient had not yet given birth, and the expected delivery date remained unknown. The batch number was not provided, and unable to contact the reporter.