Age: 28.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product administered to patient of inappropriate age, Product use issue
Clinical narrative: pregnant women received Arexvy; pregnant women received Boostrix; Underage; 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 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) for prophylaxis.   Concomitant products included Influenza vaccine (Fluzone) and meclozine hydrochloride, pyridoxine hydrochloride (Pnv).   On 13-NOV-2023, the patient received Arexvy. On 16-OCT-2023, the patient received Boostrix. On 13-NOV-2023, an unknown time after receiving Arexvy and not applicable after receiving Boostrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Underage). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: pregnant women received Arexvy) and vaccine exposure during pregnancy (Verbatim: pregnant women received Boostrix). The outcome of the inappropriate age at vaccine administration, 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 Last Menstrual Period Date: 12-MAR-2023 Estimated Delivery/Due date: 30-DEC-2023  Pregnancy Details (Neonate 1):  Number of Fetuses/Neonates: 1 Pregnancy Outcome: Pregnancy was ongoing Delivery Notes: The patient was 33 weeks 2 days pregnant at the time of the event onset with Arexvy and 29 weeks and 2 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 information received on 29-DEC-2023: The patient had normal conception and not an in vitro fertilization. The patient was 31 weeks 2 days pregnant at the time of the event onset with Fluzone. The pregnant patient received Boostrix, which led to vaccine exposure during pregnancy. Summary of Changes: Patient's last menstrual period date and gestation time updated, estimated delivery/due date updated, number of fetus, delivery note, product details for suspect, concomitant drug, and pregnancy exposure trimester, event added and narrative updated.; Sender's Comments:  US-GSK-US2023173296:1st  patient US-GSK-US2023AMR178424:6th patient US-GSK-US2023AMR178431:7th patient US-GSK-US2023AMR178395:3rd patient US-GSK-US2023AMR178415:5th patient US-GSK-US2023AMR178412:4th patient US-GSK-US2023AMR178358:2nd  patient US-GSK-US2023AMR178444:9th patient US-GSK-US2023AMR178435:8thth patient US-GSK-US2023AMR178458:11th patient US-GSK-US2023AMR178450:10th 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-US2023AMR178585:21st patient US-GSK-US2023AMR178588:22nd patient US-GSK-US2023AMR178594:23rd patient