Sex: M
Vaccine: UNK
Symptoms: Apgar score abnormal, Caesarean section, Foetal exposure during pregnancy, Low birth weight baby, Premature baby
Clinical narrative: Foetal exposure during pregnancy; Pre-term birth; Low birth weight; This is an observational study case, initially received from other health professional on 17-Jan-2020, concerning a male neonate subject, whose mother was 31-year-old, female subject of body weight 195 lbs, height 63 inches and body mass index (BMI) 34.5 enrolled in a prospective observational safety study.   The mother's current conditions included seasonal allergies, increased BMI, anxiety, hypothyroidism, acid reflux and hemolysis, elevated liver enzymes and low platelets (HELLP syndrome).  The mother's concomitant medications included Prenatal vitamins (unspecified vitamins and minerals) for pregnancy, Flonase (fluticasone propionate) and Claritin (loratadine) both for seasonal allergies, Lexapro (escitalopram oxalate) for anxiety, levothyroxine for hypothyroidism and Prilosec (omeprazole) for acid reflux.  The subject's mother had one previous pregnancy which included one spontaneous abortion. The subject's mother had no maternal or paternal history with major congenital malformations (MCMs) and had no history of offspring with MCM. The subject's mother did not use tobacco or alcohol during pregnancy.  The mother's last menstrual period (LMP) date was 22-Apr-2019, the estimated delivery date (EDD) was reported as 27-Jan-2020 and corrected estimated date of delivery (CEDD) was reported as 29-Jan-2020. The type of pregnancy was singleton. The subject's father was 31-year-old.  On 28-Aug-2019 and 25-Sep-2019, the subject's mother had an ultrasound scan and no MCMs were noted.  On 25-Sep-2019, at approximately 23 weeks of gestation, the subject's mother was administered Afluria QIV (Flu Vaccine Egg Split QIV CSL) [Influenza vaccine, batch number: P100118566, dose, route of administration, anatomical location and expiration date: not reported] (explicitly coded as Foetal exposure during pregnancy') for an influenza immunisation.  At gestational age of 32 weeks, the subject's mother delivered a live birth male neonate via caesarean method. The neonate's birth weight was 1531 g, body length was 41.3 cm and head circumference was 28.5 cm. The appearance, pulse, grimace, activity, and respiration (APGAR) scores were 5 (one minute), 7 (five minutes) and score was not provided for 10 minutes. No MCM was identified at birth.   At the time of initial reporting, the outcome of the events premature baby and low birth weight baby were not reported.  The events of premature baby and low birth weight baby were considered serious due to criterion of medical significance, per company.  The reporter did not provide causality assessment.  This case is linked to the case 201905329 (the corresponding mother case).  Company Comment: The male neonate subject was delivered as premature baby and low birth weight baby after foetal exposure during pregnancy, at gestation age of 23 weeks with the suspect product Afluria QIV. Chronology is plausible. Mother's medical history of obesity (body mass index 34.5), hypothyroidism and elevated liver enzymes and low platelets (HELLP syndrome) 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 premature baby and low birth weight baby is assessed as unlikely related (defaults to related for reporting purposes).; Sender's Comments: The male neonate subject was delivered as premature baby and low birth weight baby after foetal exposure during pregnancy, at gestation age of 23 weeks with the suspect product Afluria QIV. Chronology is plausible. Mother's medical history of obesity (body mass index 34.5), hypothyroidism and elevated liver enzymes and low platelets (HELLP syndrome) 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 premature baby and low birth weight baby is assessed as unlikely related (defaults to related for reporting purposes).