Received Mar 21, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (AREXVY) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | — |
Reporter was 34 weeks pregnant during time of Arexvy vaccination; Reporter was 34 weeks pregnant during time of Arexvy vaccination; This non-serious retrospective pregnancy case was reported by a consumer 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 gestational diabetes. Concomitant products included glipizide. On 24-JAN-2024, the patient received Arexvy. On 24-JAN-2024, an unknown time after receiving Arexvy, the patient experienced product use in unapproved population (Verbatim: Reporter was 34 weeks pregnant during time of Arexvy vaccination). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: Reporter was 34 weeks pregnant during time of Arexvy vaccination). The outcome of the vaccine exposure during pregnancy and product use in unapproved population were not applicable. Pregnancy exposure: Gestation time at first exposure (Arexvy): 34 Weeks Pregnancy Exposure (Arexvy): To mother in third trimester Pregnancy Details (Neonate 1): Actual Delivery Date: XX-FEB-2024 Number of Fetuses/Neonates: 1 Pregnancy Outcome: Live neonate with a congenital anomaly Delivery Notes: gender of the baby was female See case US2025AMR031576 for details regarding the baby case. Additional Information: GSK Receipt Date: 12-MAR-2025 The patient self-reported this case for herself. Reporter received Arexvy vaccine from pharmacy. She was 34 weeks pregnant during time of vaccination, which led to product use in unapproved population. Reporter was also taken a prenatal vitamin started on 24th June 2023 and ended on 26th February 2024 and was also taken Glipizide 2.5milligrams for gestational diabetes started on 18th December 2023 and ended on 26th February 2024. This case was linked with US2025AMR031576, reported by the same reporter.; Sender's Comments: US-GSK-US2025AMR031576:baby case
Gestational diabetes
GLIPIZIDE