Age: 28.0
Sex: F
Vaccine: FLU4, RSV
Symptoms: Delivery, Exposure during pregnancy, Product administered to patient of inappropriate age, Product use issue
Clinical narrative: 23yr pregnant women received Arexvy; 23yr pregnant women received Boostrix; 23yr pregnant women received Fluarix; Live birth; Underage/23 pregnant women received Arexvy; This non-serious prospective pregnancy case was reported by a other health professional via call center representative and described the occurrence of live birth in a 28-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 4l5m7, expiry date 29-MAR-2025) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) (batch number NR5OX, expiry date 02-FEB-2024) for prophylaxis, Flu Seasonal QIV Dresden (Fluarix Tetra 2023-2024 season) (batch number 545ZE, expiry date 30-JUN-2024) for prophylaxis and sertraline hydrochloride (Zoloft) for depression.   Concurrent medical conditions included depression.   On 04-DEC-2023, the patient received Arexvy. On 06-NOV-2023, the patient received Boostrix. On 10-OCT-2023, the patient received Fluarix Tetra 2023-2024 season. On 13-JUN-2023, the patient started Zoloft 50 mg once a day (50 mg daily). On 04-DEC-2023, an unknown time after receiving Arexvy, not applicable after receiving Boostrix and Fluarix Tetra 2023-2024 season and not applicable after receiving Boostrix and Fluarix Tetra 2023-2024 season, the patient experienced product use in unapproved population (Verbatim: Underage/23 pregnant women received Arexvy).  the patient experienced live birth (Verbatim: Live birth). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: 23yr pregnant women received Arexvy), vaccine exposure during pregnancy (Verbatim: 23yr pregnant women received Boostrix) and vaccine exposure during pregnancy (Verbatim: 23yr pregnant women received Fluarix). The action taken with Zoloft was unknown. The outcome of the live birth, product use in unapproved population, vaccine exposure during pregnancy, vaccine exposure during pregnancy and vaccine exposure during pregnancy were unknown.   Pregnancy exposure: Gestation time at first exposure (Arexvy): 33 Weeks Pregnancy Exposure (Arexvy): To mother in third trimester Gestation time at first exposure (Boostrix): 29 Weeks Pregnancy Exposure (Boostrix): To mother in third trimester Gestation time at first exposure (Fluarix Tetra 2023-2024 season): 25 Weeks Pregnancy Exposure (Fluarix Tetra 2023-2024 season): To mother in second trimester Gestation time at first exposure (Zoloft): 8 Weeks Pregnancy Exposure (Zoloft): To mother in first trimester Last Menstrual Period Date: 13-APR-2023 Estimated Delivery/Due date: 18-JAN-2024  Pregnancy Details (Neonate 1):  Actual Delivery Date:  Gestation Time at Delivery: 39 weeks and 3 days Delivery Type: abnormal vaginal Number of Fetuses/Neonates: 1 Pregnancy Outcome: Live neonate with no apparent congenital anomaly Apgar Scores: 8 and 9 Delivery Notes: The patient was 33 weeks 4 days pregnant at the time of the event onset with Arexvy and 25 weeks and 5 days pregnant at the time of the event onset with Fluarix tetra, 29 weeks 4 days pregnant at the time of the event onset with Boostrix.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   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 received on 29-DEC-2023 The patient had normal conception (included fertility drugs) and not an invitro fertilizations. The pregnant patient received Fluarix tetra and Boostrix, which led to vaccine exposure during pregnancy. Summary of changes: Patient details, product details, event details and narrative was updated.   Upon internal review the case was updated on 05-JAN-2023.  The device for Boostrix was deleted and drug Zoloft was added as suspect. Summary of changes: Product tab and narrative was updated.   Follow up information received on 01-FEB-2024 Batch number and expiry date was updated. Summary of changes: Product tab and narrative was updated.   Follow up information received on 26-SEP-2024 Gestational age at birth was 39 weeks.  The baby gender was male . Summary of changes: Pregnancy information and narrative were updated.   Upon internal review the case was updated on: 11-OCT-2024. The event was updated as product use in unapproved population from inappropriate age at vaccine administration. Summary of Changes: event details and narrative were updated.; Sender's Comments:  US-GSK-US2023AMR178565:17th patient US-GSK-US2023AMR178395:3rd patient US-GSK-US2023AMR178458:11th patient US-GSK-US2023AMR178469:13th patient US-GSK-US2023AMR178567:18th patient US-GSK-US2023AMR178489:15th patient US-GSK-US2023AMR178358:2nd  patient US-GSK-US2023AMR178415:5th patient US-GSK-US2023AMR178412:4th patient US-GSK-US2023AMR178444:9th patient US-GSK-US2023AMR178424:6th patient US-GSK-US2023AMR178435:8th patient US-GSK-US2023AMR178513:16th patient US-GSK-US2023AMR178431:7th patient US-GSK-US2023AMR178466:12th patient US-GSK-US2023173296:1st patient US-GSK-US2023AMR178481:14th patient US-GSK-US2023AMR178578:19th patient US-GSK-US2023AMR178583:20th patient US-GSK-US2023AMR178588:22nd patient US-GSK-US2023AMR178585:21st patient US-GSK-US2023AMR178450:10th patient