Age: 30.0
Sex: F
Vaccine: FLU4, UNK
Symptoms: Exposure during pregnancy, Product storage error
Clinical narrative: Fluarix was administrated and person is also PREGNANT.; Fluarix exposed to freezing temperature was administrated; This prospective pregnancy case was reported by a other health professional via call center representative and described the occurrence of vaccine exposure during pregnancy in a 30-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number LZ4N2, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis, COVID-19 AAPC VACCINE for prophylaxis, INFLUENZA VIRUS VACCINE INACTIVATED (FLUARIX TETRA) (batch number LZ4N2, expiry date 30th June 2022) for prophylaxis and TOZINAMERAN (COVID 19 VACCINE BOOSTER PFIZER) for prophylaxis.   Concurrent medical conditions included migraine (from 2013) and hypothyroidism (from 2008).   On 11th October 2021, the patient received Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. On 20th November 2021, the patient received COVID-19 AAPC VACCINE. On 11th October 2021, the patient received FLUARIX TETRA. On 20th November 2021, the patient received COVID 19 VACCINE BOOSTER PFIZER. The patient's last menstrual period was on 18th February 2021 and estimated date of delivery was 25th November 2021. The patient received Fluarix Quadrivalent 2021-2022 season at week 26 of the pregnancy. On an unknown date, unknown after receiving Fluarix Quadrivalent 2021-2022 season, Fluarix Tetra Pre-Filled Syringe Device and Aspirin (Baby), the patient experienced vaccine exposure during pregnancy and incorrect storage of drug. The patient was treated with anti-d immunoglobulin (Rhogan), acetylsalicylic acid (Aspirin (Baby)) and acetylsalicylic acid (Aspirin (Baby)). On an unknown date, the outcome of the vaccine exposure during pregnancy and incorrect storage of drug were unknown. The pregnancy was lost to follow up.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: The health care professional called and reported that a Fluarix QIV that was exposed to freezing temperature was administrated to a patient, which led to incorrect storage of vaccine. The patient was pregnant at the time of vaccination which led to vaccine exposure during pregnancy. No symptoms or further details were reported. The reporter agreed to follow-up. This case was 1 of 8 case reported by the same reporter.  Follow up information received from other health professional on 24th November 2021: The patient's demographics details were updated. The patient's concurrent condition includes Migraine (from 2013) and Hypothyroid (from 2008). The patient received Fluarix vaccine at 26th week, Rhogan on 29th October 2021 at 28 week, Aspirin (BABY) on 21st July 2021 at 14th week, COVID-19 AAPC VACCINE on 20th November 2021 at 32 week. The number of fetus was 1. The reporter stated the estimated delivery date was 17th January 2022. The reporter also stated that this was a normal conception (includes fertility drugs). Its unclear date of LMP and due date. This case includes Data merged from duplicate case USCH2021AMR085292 on 25-JUN-2022  Follow-up information received on 28-SEP-2022: This follow-up was considered significant. Reporters comment: After completion of all the follow up attempts, the pregnancy case was considered as lost to follow up. Summary of Changes: Pregnancy outcome was updated.