Age: 21.0
Sex: F
Vaccine: RSV
Symptoms: Delivery, Exposure during pregnancy, Product administered to patient of inappropriate age, Product use issue
Clinical narrative: 23 pregnant women received Arexvy; Underage/pregnant patient received Arexvy; This non-serious retrospective 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. Additional patient notes included Baby's gender: Female. 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/pregnant patient received Arexvy). 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):  Actual Delivery Date: XX-NOV-2023 Gestation Time at Delivery: 39 weeks and 2 days Delivery Type: vaginal Number of Fetuses/Neonates: 1 Pregnancy Outcome: Live neonate with no apparent congenital anomaly Birth Weight: 3118 grams (6lbs 14oz) Apgar Scores: 9 and 9   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.   Follow up information received on 26-SEP-2024 The reporter reported number of previous pregnancies was 1 with normal birth. The reporter reported parental age was 23 years. The infant gender was female and preterm. Summary of changes: Pregnancy information, event tab and narrative were updated.   Follow up information received on 16-OCT-2024 The Pregnancy outcome was updated to lost to follow up. Summary of changes: Pregnancy outcome and narrative updated.   Upon internal review the case was updated on 26-OCT-2024. The baby birth weight and event verbatim of product use in unapproved population were updated.   Follow up information received on 05-NOV-2024. The patient had pre term labor. The patient's baby birth weight 614 g/lb. Summary of Changes: Pregnancy's details, event details 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-US2023AMR178450:10th 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-US2023AMR178583:20th patient US-GSK-US2023AMR178585:21th patient US-GSK-US2023AMR178588:22th patient US-GSK-US2023AMR178594:23th patient