Sex: U
Vaccine: FLUX
Symptoms: Foetal exposure during pregnancy
Clinical narrative: Polyhydramnios; Intrauterine growth restriction; Foetal exposure during pregnancy; This is an observational study case, initially received from other health professional on 16-Jan-2020, concerning a foetal subject of an unspecified gender whose mother was a 39-year-old, female subject, of body weight 176 lbs, height 59 inches and body mass index (BMI) 35.5, enrolled in a prospective observational safety study.  The mother's current condition included obesity with BMI 35.5, advanced maternal age, pain and nausea.   The mother's concomitant medications included prenatal vitamins (unspecified vitamins and minerals) for pregnancy, Aspirin (acetylsalicylic acid) for advanced maternal age, Tylenol (paracetamol) for pain and ondansetron for nausea.  The subject's mother had no previous pregnancies. The subject's mother had no maternal or paternal history with major congenital malformations (MCMs). The subject's mother used less than five cigarettes per day and marijuana once per week, both during pregnancy. The subject's mother did not use alcohol during pregnancy.   The mother's last menstrual period (LMP) date was 25-May-2019, the estimated delivery date (EDD) was reported as 28-Feb-2020, while corrected estimated date of delivery (CEDD) was reported as 11-Feb-2020. The type of pregnancy was singleton.   On 21-Aug-2019, the subject's mother had an ultrasound scan and non-invasive prenatal testing, and no MCMs were noted.  On 30-Aug-2019, the subject's mother had an inhere test and maternal serum alpha fetoprotein screening (MSAFP), and no MCMs were noted.  On 01-Oct-2019, the subject's mother underwent 20-week anatomy ultrasound and no MCMs were noted.  On 31-Oct-2019, at approximately 22 weeks of gestation, the subject's mother was administered Afluria QIV (Flu Vaccine Egg Split QIV CSL) [influenza vaccine; 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 21-Nov-2019, the pregnancy status of the mother was collected, and it was noted that the subject had an intrauterine growth restriction.  On 12-Dec-2019, the pregnancy status of the mother was collected, and it was noted that the subject developed polyhydramnios.  At the time of initial reporting, the subject had not recovered from the events.  The events of foetal growth restriction and polyhydramnios were considered as serious due to criterion of medical significance, per company.  The reporter did not provide causality assessment.  This case is linked to the case 202000267 (the corresponding mother case).  Company Comment: The neonate subject experienced foetal growth restriction and polyhydramnios after foetal exposure during pregnancy, at gestation age of 22 weeks with the suspect product Afluria QIV. Chronology is plausible. Mother's medical history of obesity (body mass index 35.5), advanced maternal age (39), cigarettes and marijuana use may provide alternative aetiology for the events. Causality is also confounded by therapy with multiple concomitant medications. Foetal exposure during pregnancy is assessed as not related per company's conventions. Causality between suspect product and the events foetal growth restriction and polyhydramnios is assessed as unlikely related (defaults to related for reporting purposes).; Sender's Comments: The neonate subject experienced foetal growth restriction and polyhydramnios after foetal exposure during pregnancy, at gestation age of 22 weeks with the suspect product Afluria QIV. Chronology is plausible. Mother's medical history of obesity (body mass index 35.5), advanced maternal age (39), cigarettes and marijuana use may provide alternative aetiology for the events. Causality is also confounded by therapy with multiple concomitant medications. Foetal exposure during pregnancy is assessed as not related per company's conventions. Causality between suspect product and the events foetal growth restriction and polyhydramnios is assessed as unlikely related (defaults to related for reporting purposes).