Received May 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (AREXVY) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | — |
pregnant patient was administered Arexvy; pregnant patient was administered Arexvy; pregnant patient was administered Arexvy; This non-serious prospective pregnancy case was reported by a pharmacist via call center representative and described the occurrence of vaccine exposure during pregnancy in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. Concurrent medical conditions included pregnancy. 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: pregnant patient was administered Arexvy), drug use in unapproved age group (Verbatim: pregnant patient was administered Arexvy) and inappropriate age at vaccine administration (Verbatim: pregnant patient was administered Arexvy). The outcome of the vaccine exposure during pregnancy, drug use in unapproved age group and inappropriate age at vaccine administration were not applicable. Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing Additional Information: GSK receipt date: 23-APR-2025 Other HCP reported that a pregnant patient was administered Arexvy, which led to vaccine exposure during pregnancy and drug use in unapproved population. This was reported to him by the patient's mother.
Medical History/Concurrent Conditions: Pregnancy