Age: 33.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product administered to patient of inappropriate age, Product use issue
Clinical narrative: 23 pregnant women received AREXVY; 23 pregnant women received boostrix; 23 pregnant women received fluarix; pregnant women received bupropion; Underdose; This non-serious prospective pregnancy case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 33-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) for prophylaxis, Flu Seasonal QIV Dresden (Fluarix Tetra 2023-2024 season) for prophylaxis, bupropion hydrochloride (Bupropion) tablet for depression, levothyroxine tablet for hypothyroidism and fluoxetine hydrochloride (Fluxetine) for depression.   Concurrent medical conditions included hypothyroidism, depression and hypertension.   On 15-NOV-2023, the patient received Arexvy. On 08-NOV-2023, the patient received Boostrix. On 25-OCT-2023, the patient received Fluarix Tetra 2023-2024 season. In 2022, the patient started Bupropion 150 mg twice a day (300 mg daily). On 27-SEP-2023, the patient started levothyroxine 25 mg once a day (25 mg daily). On an unknown date, the patient started Fluxetine 20 mg once a day (20 mg daily). On 15-NOV-2023, an unknown time after receiving Arexvy, not applicable after receiving Boostrix and Fluarix Tetra 2023-2024 season, not applicable after receiving Boostrix and Fluarix Tetra 2023-2024 season and an unknown time after starting Bupropion, the patient experienced inappropriate age at vaccine administration (Verbatim: Underdose). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: 23 pregnant women received AREXVY), vaccine exposure during pregnancy (Verbatim: 23 pregnant women received boostrix), vaccine exposure during pregnancy (Verbatim: 23 pregnant women received fluarix) and drug exposure during pregnancy (Verbatim: pregnant women received bupropion). The action taken with Bupropion was unknown. The action taken with levothyroxine was unknown. The action taken with Fluxetine was unknown. The outcome of the inappropriate age at vaccine administration, vaccine exposure during pregnancy, vaccine exposure during pregnancy, vaccine exposure during pregnancy and drug 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): 32 Weeks Pregnancy Exposure (Boostrix): To mother in third trimester Gestation time at first exposure (Fluarix Tetra 2023-2024 season): 30 Weeks Pregnancy Exposure (Fluarix Tetra 2023-2024 season): To mother in third trimester Pregnancy Exposure (Bupropion): Trimester unknown Gestation time at first exposure (levothyroxine): 26 Weeks Pregnancy Exposure (levothyroxine): To mother in third trimester Pregnancy Exposure (Fluxetine): Trimester unknown Last Menstrual Period Date: 24-MAR-2023 Estimated Delivery/Due date: 04-JAN-2024  Pregnancy Details (Neonate 1):  Number of Fetuses/Neonates: 1 Pregnancy Outcome: Pregnancy was ongoing Delivery Notes: The patient was 32 weeks 6 days pregnant at the time of the event onset with Arexvy and 31 weeks, 6 days pregnant at the time of the event onset with Boostrix and 29 weeks, 6 days pregnant at the time of the event onset with fluarix.   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 information received on 28-DEC-2023 The patient had normal conception (included fertility drugs) and not an invitro fertilizations. Patient started to receive Fluxetine on 2021 and bupropion on 2022. Patient received Procardia xl tablet 30 mg daily started on 05 July 2023 for HTN (hypertension). Summary of Changes: The patient's demographics, pregnancy details, new suspect added and its details, event details and narrative were updated.; Sender's Comments:  US-GSK-US2023AMR178415:5th patient US-GSK-US2023AMR178424:6th patient US-GSK-US2023AMR178358:2nd patient US-GSK-US2023AMR178395:3rd patient US-GSK-US2023AMR178431:7th patient US-GSK-US2023173296:1st patient US-GSK-US2023AMR178412:4th patient US-GSK-US2023AMR178466:12th patient US-GSK-US2023AMR178435:8th patient US-GSK-US2023AMR178444:9th patient US-GSK-US2023AMR178567:18th patient US-GSK-US2023AMR178469:13th patient US-GSK-US2023AMR178458:11th patient US-GSK-US2023AMR178565:17th patient US-GSK-US2023AMR178481:14th patient US-GSK-US2023AMR178513:16th patient US-GSK-US2023AMR178578:19th patient US-GSK-US2023AMR178450:10th patient US-GSK-US2023AMR178583:20th patient US-GSK-US2023AMR178585:21st patient US-GSK-US2023AMR178588:22nd patient US-GSK-US2023AMR178594:23rd patient