Sex: U
Vaccine: FLUX
Symptoms: Exposure during pregnancy, Foetal disorder, Foetal gastrointestinal tract imaging abnormal
Clinical narrative: Echogenic bowel; Foetal exposure during pregnancy; This is an observational study case, initially received from other health professional on 06-Feb-2020, concerning a foetal subject whose mother was a 25-year-old, pregnant, female subject, of body weight: 168 lbs, height: 70 inches and body mass index (BMI): 24.1, enrolled in, a prospective observational safety study.  The subject's mother's current conditions included anemia, pre-eclampsia and gestational hypertension.   The subject's mother's concomitant medications included Prenatal vitamins (unspecified vitamins and minerals) for pregnancy and ferrous sulphate for anemia.  The subject's mother's obstetrical history noted that the mother had two previous pregnancies with one full term live birth and one preterm live birth at 35 weeks. The subject's mother had one twin pregnancy with the outcome with birth defect including gastroschisis of first baby. The subject's mother had no maternal or paternal history with major congenital malformations (MCMs). Also, the subject's mother had no history of offspring with MCM. The subject's mother used 10 cigarettes per day during pregnancy, while she did not use alcohol or illicit drugs during pregnancy.   The subject's mother's last menstrual period (LMP) date was on 02-Jul-2019, the estimated delivery date (EDD) was reported as 07-Apr-2020, while corrected estimated delivery date (CEDD) was not reported. The type of pregnancy was multiple (twin gestation). The subject's father age was not reported.  On 27-Aug-2019, the subject's mother underwent ultrasound and no MCMs were noted.   On 25-Sep-2019, the subject's mother underwent non-invasive prenatal testing (NIPT) and nuchal translucency, and no MCMs were noted.  On 23-Oct-2019, the subject's mother underwent maternal serum alpha fetoprotein screening (MSAFP) and no MCMs were noted.  On 19-Nov-2019, at approximately 20 weeks of gestation, the subject's mother was administered Afluria QIV (Flu Vaccine Egg Split QIV CSL) [influenza vaccine, subunit influenza virus vaccine polyvalent, cell cultured derived; batch number: P100112488, dose, route of administration, anatomical location and expiration date: not reported] (explicitly coded as Foetal exposure during pregnancy') for an influenza immunisation.   On the same day, the subject's mother underwent 20-week anatomy ultrasound scan and echogenic bowel in twin A was noted. No MCMs were noted.   At the time of this report, the subject had not recovered from the event of foetal gastrointestinal tract imaging abnormal'.  The event of foetal gastrointestinal tract imaging abnormal' was considered as serious due to criterion of medical significance, per company.  The reporter did not provide causality assessment.  This case is linked to case number 202001668, the corresponding mother case.  Company comment: A 25-year-old pregnant subject was administered Afluria QIV at gestational age of 20 weeks and Foetal gastrointestinal tract imaging abnormal was noted on the same day. Considering implausible temporal relationship, causality between suspect product and Foetal gastrointestinal tract imaging abnormal is assessed as not related. Foetal exposure during pregnancy is not related per company's conventions.; Sender's Comments: A 25-year-old pregnant subject was administered Afluria QIV at gestational age of 20 weeks and Foetal gastrointestinal tract imaging abnormal was noted on the same day. Considering implausible temporal relationship, causality between suspect product and Foetal gastrointestinal tract imaging abnormal is assessed as not related. Foetal exposure during pregnancy is not related per company's conventions.