Received Sep 16, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (AREXVY) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | — |
Arexvy administration to pregnant patient; Arexvy administration to pregnant patient; This non-serious prospective pregnancy case was reported by a other health professional 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: Arexvy administration to pregnant patient) and product use in unapproved population (Verbatim: Arexvy administration to 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: Lost to follow up Additional Information: GSK Receipt Date: 30-OCT-2024 The reporter called inquiring if Arexvy was safe for pregnant woman. The office was giving it to pregnant patient. The reporter stated that there was pregnant patient who received Arexvy recently, which led to vaccine exposure during pregnancy and product use in unapproved population. The reporter had no additional information but would ask nurse practitioner to call with more details. No lot/expiration date were available. No patient details were available. No dates of administration were available. This was 1 of 3 linked cases, reported by the same reporter. Follow up information received on 10-SEP-2025 This pregnancy case was now considered lost to follow-up. Summary of changes: Pregnancy outcome, description to be coded and narrative were updated.; Sender's Comments: US-GSK-US2024134993:patient 1 US-GSK-US2024AMR142776:Patient 2