Sex: F
Vaccine: UNK
Symptoms: Caesarean section, Foetal distress syndrome, Foetal exposure during pregnancy
Clinical narrative: Fetal intolerance of labor; Foetal exposure during pregnancy; This is an observational study case, initially received from other health professional on 13-Mar-2020, concerning a foetus subject whose mother was a 24-year-old, pregnant, female subject of body weight: 96.4 lbs, height: 57 inches and body mass index (BMI): 20.9, enrolled in a prospective observational safety study on pregnancy outcomes in women immunized with seasonal cell culture influenza trivalent (TIVc) or quadrivalent (QIVc) vaccine during pregnancy.  The subject's mother's medical history included anxiety and nausea.   The subject's mother's concomitant medications included ondansetron and Bonjesta (doxylamine succinate, pyridoxine hydrochloride) both for nausea, Tdap (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid) as vaccine immunisation and Elite-OB plus iron (unspecified vitamins and minerals) as vitamin supplementation.   The mother had no obstetrical history. The subject's mother had no history of offspring with major congenital malformation (MCM) and no relevant maternal and paternal medical history with MCM.   The subject's mother last menstrual period (LMP) date was 28-May-2019. The type of pregnancy was singleton. The estimated delivery date (EDD) and corrected estimated date of delivery (CEDD) were reported as 03-Mar-2020. The subject's mother did not use tobacco, alcohol or illicit drugs during pregnancy. The subject's father was 26-year-old.   On 30-Aug-2019, the mother underwent first trimester screen and no MCM was noted.   On 16-Sep-2019, the mother underwent second trimester screen and no MCM was noted.   On 11-Oct-2019, approximately at 19 weeks of gestation (calculated per LMP), the subject's mother was administered Flucelvax QIV (Flu Vaccine Cell Subunit QIV NVD) [influenza vaccine, subunit influenza virus vaccine polyvalent, batch number: 261207, dose: 0.5 ml, route of administration, anatomical location and expiration date: not reported] for an influenza immunization (explicitly coded as 'Foetal exposure during pregnancy'). On the same day, the mother underwent anatomy ultrasound scan and no MCM was noted.   At gestational age of 40.3 weeks (as reported), the mother delivered live, female neonate of birth weight 3459 grams by caesarean method. The neonate's head circumference and body length were not reported. The appearance, pulse, grimace, activity, and respiration (APGAR) scores were not reported for one minute, five and ten minutes. Pregnancy complication identified at birth was fetal intolerance of labor.   At the time of this report, the outcome of the event 'fetal distress first noted during labor, in liveborn infant' was not reported.   The event of fetal distress first noted during labor, in liveborn infant' is assessed as serious due to the criterion of medical significance.   The reporter did not provide causality assessment.   This case is linked to 202000515 (the corresponding mother's case).  Company Comment: A neonate subject experienced Foetal distress syndrome (reported as foetal intolerance of labour) 4 months and 23 days after foetal exposure to the suspect product Flucelvax QIVc. Mother was administered Flucelvax QIVc at approximately at 19 weeks of gestation. Chronology is unsuggestive. Mother's medical history included anxiety and nausea. No alternative aetiology was found, therefore causal role of the suspect product cannot be excluded and is assessed as unlikely related (defaults to related for reporting purposes). Foetal exposure during pregnancy is assessed as not related per company conventions.; Sender's Comments: A neonate subject experienced Foetal distress syndrome (reported as foetal intolerance of labour) 4 months and 23 days after foetal exposure to the suspect product Flucelvax QIVc. Mother was administered Flucelvax QIVc at approximately at 19 weeks of gestation. Chronology is unsuggestive. Mother's medical history included anxiety and nausea. No alternative aetiology was found, therefore causal role of the suspect product cannot be excluded and is assessed as unlikely related (defaults to related for reporting purposes). Foetal exposure during pregnancy is assessed as not related per company conventions.