Received Mar 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (AREXVY) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | — |
Patient received Arexvy while she was pregnant; patient received Arexvy instead of Abrysvo; patient received Arexvy instead of Abrysvo; This non-serious retrospective 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. Co-suspect products included RSV vaccine prot. subunit PreF 2v (Abrysvo) for prophylaxis. On an unknown date, the patient received Arexvy and did not receive Abrysvo. On an unknown date, an unknown time after receiving Arexvy, the patient experienced vaccine exposure during pregnancy (Verbatim: Patient received Arexvy while she was pregnant), wrong vaccine administered (Verbatim: patient received Arexvy instead of Abrysvo) and drug use in unapproved population (Verbatim: patient received Arexvy instead of Abrysvo). The outcome of the vaccine exposure during pregnancy, wrong vaccine administered and drug use in unapproved population were not applicable. Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Exposure (Abrysvo): Trimester unknown Pregnancy Outcome: Live neonate with a congenital anomaly See case US2025AMR030558 for details regarding the baby case. Additional Information: GSK Receipt Date: 12-MAR-2025 A pharmacist mentioned that a patient received Arexvy instead of Abryvso while she was pregnant, which led to Wrong vaccine administered, Drug use in unapproved population and Vaccine exposure during pregnancy. The pharmacist asked if GlaxoSmithKline had any study showing a correlation of giving Arexvy to pregnant women and respiratory issues in newborns.; Sender's Comments: US-GSK-US2025AMR030558:Child case