Sex: F
Vaccine: FLUX
Symptoms: Apgar score low, Delivery, Foetal exposure during pregnancy, Intensive care, Low birth weight baby
Clinical narrative: Foetal heart decelerations; Low birth weight; Premature birth; Foetal exposure during pregnancy; This is an observational study case, initially received from other health professional on 13-Mar-2020, concerning a foetal subject, whose mother was 39-year-old, pregnant female subject (body weight: 177 lbs, height: 64 inches and body mass index (BMI): 30.4, enrolled in a prospective observational safety study.   The mother's medical history included advanced maternal age, BMI increased, genital herpes simplex virus and vaginal yeast.   The mother's concomitant medications included metronidazole for vaginal yeast, Makena (hydroxyprogesterone caproate) for history of preterm labor and Prenatal vitamins with iron (unspecified vitamins and minerals) as vitamin supplementations.   The subject's mother obstetrical history included four previous pregnancies with three full term live births and one preterm delivery. The mother had no history of offspring with major congenital malformation (MCM) and no relevant maternal and paternal medical history. The subject's mother did not use tobacco, alcohol or illicit drugs during pregnancy.   The subject's mother last menstrual period (LMP) date was 21-Jun-2019. The type of pregnancy was singleton. The subject's mother estimated delivery date (EDD) and corrected estimated date of delivery (CEDD) were reported as 27-Mar-2020.   On 17-Sep-2019, the mother underwent nuchal translucency and Maternit 21 test and no MCM was noted.   On 03-Oct-2019, approximately at 15 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] (explicitly coded as 'Foetal exposure during pregnancy') for an influenza immunization.  On 18-Oct-2019, the mother underwent second trimester screen and maternal serum alpha fetoprotein screening (MSAFP/ serum markers) and no MCM was noted.   On 01-Nov-2019, the mother underwent anatomy ultrasound scan and no MCM was noted.  On an unspecified date, the subject's mother experienced marginal placental abruption.    The subject's mother experienced spontaneous rupture of membranes (SROM) and premature rupture of membranes (PROM).   On the same day, at gestational age of 32.9 weeks (as reported), the subject's mother gave a vaginal birth after caesarean (VABC) to live, female neonate of birth weight 2013 grams. The neonate's head circumference and body length were not reported. The appearance, pulse, grimace, activity, and respiration (APGAR) scores were 5 at one minute and 8 at five minutes. APGAR score for 10 minutes was not reported. Pregnancy was complicated by foetal heart decelerations affecting management of mother. The subject was sent to neonate intensive care unit (NICU).  At the time of this report, the outcome of all events was not reported.   The subject's mother date of completion of registry was 13-Mar-2020.   Per company, the events of 'foetal heart rate deceleration', 'low birth weight baby' and 'premature birth' were considered serious due to the criterion of medical significance.  The reporter did not provide causality assessment to Flucelvax QIV.   This case is linked to 202002409 (corresponding mother case).  Company Comment: A neonate subject experienced premature birth and low birth weight 4 months after foetal exposure to the suspect product Flucelvax QIVc. On an unknown date, pregnancy was complicated by foetal heart rate deceleration abnormality. Mother was administered Flucelvax QIVc at approximately at 15 weeks of gestation. Chronology is unsuggestive. Causality was confounded by advanced maternal age. 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 premature birth and low birth weight 4 months after foetal exposure to the suspect product Flucelvax QIVc. On an unknown date, pregnancy was complicated by foetal heart rate deceleration abnormality. Mother was administered Flucelvax QIVc at approximately at 15 weeks of gestation. Chronology is unsuggestive. Causality was confounded by advanced maternal age. 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.