Sex: F
Vaccine: UNK
Symptoms: Intensive care, Laryngomalacia, Low birth weight baby, Premature baby
Clinical narrative: Intrauterine growth restriciton; Foetal exposure during pregnancy; Preterm birth; Low birth weight; Laryngomalacia; This is an observational study case, initially received from other health professional on 06-Aug-2019, concerning an infant subject. The mother was a 24-year-old, female pregnant subject of body weight: 221 lbs, height: 60 inches and body mass index (BMI): 43.2, enrolled in a prospective observational safety study.  The mother's concomitant medications included prenatal vitamins (unspecified vitamins and minerals, 1 tablet orally every day, from 18-Oct-2018 to 08-Feb-2019, for pregnancy and promethazine for nausea. The mother's medical history included nausea.  The mother's obstetrical history included three previous pregnancies: two live births and one spontaneous abortion. The mother had no history of offspring with major congenital malformation nor maternal or paternal history with major congenital malformations. The mother did not use tobacco, alcohol or illicit drugs during pregnancy. The pregnancy status of the mother was collected and there were no complications noted.  The mother's last menstrual period (LMP) was 15-Jun-2018. The type of pregnancy was singleton. The estimated delivery date (EDD) was 22-Mar-2019 and corrected estimated date of delivery (CEDD) was 05-Mar-2019.   On 18-Oct-2018, haemoglobin electrophoresis, spinal muscular atrophy screen and fibrosis mutation analysis were done and no major congenital malformation (MCM) were noted.  On 01-Nov-2018, at gestation age of 19 weeks, the mother was administered with Flu Vaccine Cell Subunit QIV NVD [influenza vaccine, subunit influenza virus vaccine polyvalent, batch number: 252664, route of administration, expiration date and anatomical location were not reported] (explicitly coded as foetal exposure during pregnancy) for influenza immunisation. On the same day, ultrasound was performed and no MCM were noted.  On an unspecified date, the mother developed oligohydramnios.  On 08-Feb-2019, three months and seven days after vaccination, at 36,4 weeks gestation, the mother gave a live birth to normal female neonate by caesarean delivery. The neonate's birth weight was 1928 grams (head circumference and body length were not reported). The appearance, pulse, grimace, activity, and respiration (APGAR) scores were 8 at one minute and 8 at five minutes. APGAR score was not reported for 10 minutes. On the same day, the congenital malformation laryngomalacia was noted by neonatal intensive care unit, possibly due to preterm birth and intrauterine growth restriction, as reported.   At the time of follow up, the outcome of the events low birth weight, preterm birth, intrauterine growth restriction and laryngomalacia was not reported.   This case is linked to 201904355, the corresponding mother report.  Follow up received from other health professional on 03-Sep-2019 and process together on 04-Sep-2019 included: The events of laryngomalacia and intrauterine growth restriction added. Indications for concomitant medications populated with null flavors. Narrative was amended accordingly.   Company comment: Reportedly, the female neonate subject was delivered as premature baby, low birth weight baby, with laryngomalacia and foetal growth restriction after foetal exposure during pregnancy, at gestation age of 19 weeks with the suspect product Flu Vaccine Cell Subunit QIV NVD. Chronology is plausible. The mother's historical conditions of class 3 obesity (BMI 43.2) may have contributed to development of the events. Causality was confounded by therapy with concomitant medication promethazine. Foetal exposure during pregnancy is assessed as unrelated based on company's conventions. For all other events, causal role of the suspect product cannot be totally excluded and is assessed as related.; Reporter's Comments: Reportedly, the female neonate subject was delivered as premature baby, low birth weight baby, with laryngomalacia and foetal growth restriction after foetal exposure during pregnancy, at gestation age of 19 weeks with the suspect product Flu Vaccine Cell Subunit QIV NVD. Chronology is plausible. The mother's historical conditions of class 3 obesity (BMI 43.2) may have contributed to development of the events. Causality was confounded by therapy with concomitant medication promethazine. Foetal exposure during pregnancy is assessed as unrelated based on company's conventions. For all other events, causal role of the suspect product cannot be totally excluded and is assessed as related.