Age: 31.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Delivery, Exposure during pregnancy, Product administered to patient of inappropriate age, Product use issue
Clinical narrative: pregnant women received AREXVY; pregnant women received Boostrix; pregnant women received levothyroxin; Live birth; 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 31-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, levothyroxine sodium (Levothyroxine) tablet for hypothyroidism, labetalol hydrochloride (Labetalol) tablet for hypertension and glibenclamide (Glyburide) tablet for gestational diabetes.   The patient's past medical history included gestational diabetes. Concurrent medical conditions included hypertension (had a hypertention), hypothyroidism (had a hypothyroid), diabetes (had a diabeties) and depression.   On 13-NOV-2023, the patient received Arexvy. On 16-OCT-2023, the patient received Boostrix. On an unknown date, the patient started Levothyroxine 125 mg. On 11-SEP-2023, the patient started Labetalol 500 mg twice a day (1000 mg daily). On 29-JUL-2023, the patient started Glyburide 2.5 mg. On 13-NOV-2023, an unknown time after receiving Arexvy, not applicable after receiving Boostrix and Levothyroxine, not applicable after starting Boostrix and Levothyroxine and 63 days after starting Labetalol, the patient experienced inappropriate age at vaccine administration (Verbatim: underage). On XX-DEC-2023, the patient experienced live birth (Verbatim: Live birth). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: pregnant women received AREXVY), vaccine exposure during pregnancy (Verbatim: pregnant women received Boostrix) and vaccine exposure during pregnancy (Verbatim: pregnant women received levothyroxin). The action taken with Levothyroxine was unknown. The action taken with Labetalol was unknown. The action taken with Glyburide was unknown. The outcome of the inappropriate age at vaccine administration, vaccine exposure during pregnancy, vaccine exposure during pregnancy, vaccine exposure during pregnancy and live birth were unknown.   Pregnancy exposure: Gestation time at first exposure (Arexvy): 32 Weeks Pregnancy Exposure (Arexvy): To mother in third trimester Gestation time at first exposure (Boostrix): 28 Weeks Pregnancy Exposure (Boostrix): To mother in third trimester Pregnancy Exposure (Levothyroxine): Trimester unknown Gestation time at first exposure (Labetalol): 23 Weeks Pregnancy Exposure (Labetalol): Trimester unknown Gestation time at first exposure (Glyburide): 17 Weeks Pregnancy Exposure (Glyburide): Trimester unknown Last Menstrual Period Date: 01-APR-2023 Estimated Delivery/Due date: 06-JAN-2024  Pregnancy Details (Neonate 1):  Actual Delivery Date: XX-DEC-2023 Gestation Time at Delivery: 37 weeks and 2 days Delivery Type: vaginal Number of Fetuses/Neonates: 1 Pregnancy Outcome: Live neonate with no apparent congenital anomaly Birth Weight: 2721 grams (6lbs) Apgar Scores: 6 and 6 Delivery Notes: The patient was 32 weeks 1 days pregnant at the time of the event onset with Arexvy and 28 weeks and 2 days pregnant at the time of the event onset with Boostrix. The gestational age at time of delivery was 37 weeks. The gender of infant reported was female.   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 28-DEC-2023: The patient had normal conception (included fertility drugs) and not an invitro fertilizations. Summary of changes: Patient details, Product details and narrative was updated.   Follow-up information received on 28-DEC-2023: It was unknown if the reporter considered the Inappropriate age at vaccine administration, Vaccine exposure during pregnancy, Vaccine exposure during pregnancy, Vaccine exposure during pregnancy to be related Labetalol, GLYBURIDE. The frequency of Levothyroxine daily dose was 125 mg qd and the frequency of GLYBURIDE daily dose was 2.5 mg qd. Summary of Changes: Patient current condition, delivery note, product details for suspect, concomitant drug, and event added 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.   Upon interval review the case was updated on 21ST August 2024 TTO for event pain was updated. Summary of changes: Event tab and narrative was updated.   Follow up information received on 26-SEP-2024 Summary of changes: Patient tab, event tab and narrative was updated.; Sender's Comments:  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-US2023AMR178458:11th patient US-GSK-US2023AMR178466:12th patient US-GSK-US2023AMR178444:9th patient US-GSK-US2023AMR178565:17th patient US-GSK-US2023AMR178435:8th patient US-GSK-US2023AMR178415:5th patient US-GSK-US2023AMR178450:10th patient US-GSK-US2023AMR178481:14th patient US-GSK-US2023AMR178489:15th patient US-GSK-US2023AMR178513:16th patient US-GSK-US2023AMR178567:18th patient US-GSK-US2023AMR178578:19th patient US-GSK-US2023AMR178583:20th patient US-GSK-US2023AMR178585:21th patient US-GSK-US2023AMR178588:22nd patient US-GSK-US2023AMR178594:23rd patient