Age: 21.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product use issue
Clinical narrative: 23 pregnant women received Arexvy; Underage; This non-serious prospective pregnancy case was reported by a other health professional and described the occurrence of vaccine exposure during pregnancy in a 21-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 4l5m7, expiry date 29-MAR-2025) for prophylaxis.   Concurrent medical conditions included depression and anxiety. Concomitant products included escitalopram.   On 26-OCT-2023, the patient received Arexvy. On 26-OCT-2023, an unknown time after receiving Arexvy, the patient experienced product use in unapproved population (Verbatim: Underage). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: 23 pregnant women received Arexvy). The outcome of the vaccine exposure during pregnancy and product use in unapproved population were unknown.   Pregnancy exposure: Gestation time at first exposure (Arexvy): 36 Weeks Pregnancy Exposure (Arexvy): To mother in third trimester Last Menstrual Period Date: 05-FEB-2023 Estimated Delivery/Due date: 21-NOV-2023  Pregnancy Details (Neonate 1):  Number of Fetuses/Neonates: 1 Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 11-DEC-2023 The reporter was CMA (clinic account manager). The pregnant patient received Arexvy below the recommended age schedule, which led to inappropriate age at vaccine administration and vaccine exposure during pregnancy. The reporter consented to follow up. This was 1 of 23 linked cases, reported by the same reporter.   Follow-up information received on 22-FEB-2024 The reporter reported that the pregnancy was normal conception. Patient received escitalopram tablet before conception for depression and anxiety. Summary of changes: Patient last menstrual date, estimate date of delivery, pregnancy trimester, gestational period, race information, product tab and narrative were updated.   Upon internal review the case was updated on 21-MAR-2024 The product Escitalopram updated from suspect to concomitant. Summary of changes: Pregnancy due date, product tab, patient relevant history and narrative were updated.   Upon internal review the case was updated on 02-MAY-2024 Inappropriate age at vaccine administration this event updated as Product use in unapproved population. Summary of changes: Event tab and narrative were updated.; Sender's Comments:  US-GSK-US2023AMR178358:2nd patient US-GSK-US2023173296:1st  PATIENT US-GSK-US2023AMR178412:4th patient US-GSK-US2023AMR178415:5th patient US-GSK-US2023AMR178424:6th patient US-GSK-US2023AMR178431:7th patient US-GSK-US2023AMR178435:8th patient US-GSK-US2023AMR178444:9th patient US-GSK-US2023AMR178450:10 th patient US-GSK-US2023AMR178458:11th patient US-GSK-US2023AMR178466:12th patient US-GSK-US2023AMR178469:13th patient US-GSK-US2023AMR178481:14th patient US-GSK-US2023AMR178489:15th patient US-GSK-US2023AMR178513:16th patient US-GSK-US2023AMR178565:17th patient US-GSK-US2023AMR178567:18th patient US-GSK-US2023AMR178578:19th patient US-GSK-US2023AMR178583:20 th patient US-GSK-US2023AMR178585:21th patient US-GSK-US2023AMR178588:22th patient US-GSK-US2023AMR178594:23th patient