Sex: M
Vaccine: UNK
Symptoms: Apgar score normal, Caesarean section, Foetal exposure during pregnancy, Large for dates baby
Clinical narrative: Foetal exposure during pregnancy; Subject's birth weight 4.281 kg; This is an observational study case, initially received from other health professional on 30-Jan-2020, concerning a neonate male patient, whose mother was a 27-year-old, pregnant, female subject of body weight 139 lbs, height 64 inches and body mass index (BMI) 23.9, enrolled in a prospective observational safety study.   The mother's current conditions included anaemia, migraine, nasal congestion and thrombocytopenia.   The subject's mother concomitant medications included ferrous sulfate for anemia, Tylenol (paracetamol) and Fioricet (butalbital, caffeine, paracetamol) for migraine, Flonase (fluticasone propionate) for nasal congestion and Prenatal 19 (ascorbic acid, calcium carbonate, calcium pantothenate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol, riboflavin, thiamine hydrochloride, tocopheryl acetate, zinc oxide) as pregnancy suplementation.  The subject mother's obstetrical history noted that the mother had no previous pregnancies. The subject's 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 14-Mar-2019, the estimated delivery date (EDD) was 19-Dec-2019 and corrected estimated date of delivery (CEDD) was 21-Dec-2019. The pregnancy was singleton. The subject's father was 30-year-old.  On 02-May-2019 and 13-May-2019, the subject's mother underwent ultrasound and no MCM was noted.  On 06-Jun-2019, the subject's mother underwent inheritest and ultrasound and no MCM was noted.  On 26-Jul-2019, the subject's mother underwent ultrasound and no MCM was noted.  On 19-Sep-2019, at gestational age of 27 weeks, the subject's mother was administered Afluria QIV (Flu Vaccine Egg Split QIV CSL) [influenza vaccine; batch number: P100115154, dose, anatomical location, route of administration and expiration date: not reported] (explicitly coded as Foetal exposure during pregnancy') for influenza immunisation.   At gestational age of 41.3 weeks, the subject's mother delivered live birth, male neonate by caesarean section method. The neonate's birth weight was 4281 g, his head circumference and length were not provided. The appearance, pulse, grimace, activity, and respiration (APGAR) scores were 7 (one minute) and 8 (five minutes). There was no major congenital malformation identified at birth. At the time of delivery, no pregnancy complications were reported.   At the time of this report, the outcome of the event was not reported.   The event of 'birth weight excessive' was assessed as serious due to criterion of medical significance, per company.  The reporter did not provide causality assessment.  The case is linked to case 201907461, the corresponding mother case.  Company Comment: The neonate was delivered as large for dates baby after foetal exposure during pregnancy at approximately 27 weeks of gestation with the suspect product, Afluria QIV. Chronology is plausible. Pregnant state may provide alternative aetiology for the event. Foetal exposure during pregnancy is assessed as not related per company's conventions. Considering all the above mentioned, causality between suspect product and the event large for dates baby is assessed as unlikely related (defaults to related for reporting purposes).; Sender's Comments: The neonate was delivered as large for dates baby after foetal exposure during pregnancy at approximately 27 weeks of gestation with the suspect product, Afluria QIV. Chronology is plausible. Pregnant state may provide alternative aetiology for the event. Foetal exposure during pregnancy is assessed as not related per company's conventions. Considering all the above mentioned, causality between suspect product and the event large for dates baby is assessed as unlikely related (defaults to related for reporting purposes).