Sex: M
Vaccine: UNK
Symptoms: Apgar score normal, Foetal exposure during pregnancy, Large for dates baby, Vacuum extractor delivery
Clinical narrative: Foetal exposure during pregnancy; Birth weight was 4196 g; This is a retrospective study case, received from other health professional on 04-Sep-2020, concerned a male neonate, whose mother was 24-year-old, pregnant, female subject of body weight: 133.5 lbs, height: 63.5 inches and body mass index (BMI): 23.3, enrolled in a prospective observational safety study.  The neonates' mother's medical history was not reported. The neonates' mother's concomitant medications included Prenatal vitamins (unspecified vitamins and minerals) for pregnancy and iron supplement as health supplement.  The neonates' mother had no obstetrical history. The neonates' mother did not have a history of offspring with major congenital malformation (MCM). The neonates' mother had no relevant maternal and paternal medical history with MCM.   The neonates' mother's last menstrual period (LMP) date was 13-Nov-2019. The type of pregnancy was singleton. The estimated delivery date (EDD) was reported as 20-Aug-2020 and the corrected estimated date of delivery (CEDD) was 19-Aug-2020. The neonates' mother did not use tobacco, illicit drug or alcohol during pregnancy.  On 09-Mar-2020, at gestational age of 16 weeks (calculated per LMP), the subject was vaccinated with Afluria QIV (Flu Vaccine Egg Split QIV CSL) [influenza vaccine, dose, route of administration, anatomical location: not reported] (explicitly coded as 'Foetal exposure during pregnancy') for an influenza immunisation.  The batch number reported was P100126099.  On the same day, the neonates' mother underwent ultrasound scan and no MCM was noted.  On 23-Mar-2020, the neonates' mother underwent ultrasound scan and no MCM was noted.  On 21-Apr-2020, approximately one month after vaccination, the neonates' mother developed anemia.  At gestational age of 41 weeks (as reported), the mother vacuum-assisted vaginally delivered live birth, male neonate. The neonate's birth weight was 4196 grams, body length: 55.9 cm and head circumference: 36 cm. The appearance, pulse, grimace, activity, and respiration (APGAR) score was at one minute 7, at five minutes 9 and at ten minutes was not reported. No MCM was identified at birth.   The outcome of the event of large for dates baby' was not reported.  The reporter did not provide a causality assessment.  The event of large for dates baby' was considered to be medically significant by a Physician within Seqirus's Pharmacovigilance and Risk Management Department.  The case is linked to case 202003411 (the corresponding mother's case).  Company comment: The neonate's mother was administered the suspect product, Afluria QIV at approximately 16 weeks of gestation (explicitly coded as Foetal exposure during pregnancy'). Reportedly, at 41 weeks of gestation, the subject vacuum-assisted vaginally delivered live birth, male neonate whose birth weight was 4196 grams (coded as large for dates baby). For the event large for dates baby, causal role of the suspect product is assessed as not related due to biological implausibility. Per some sources, the range of normal is between 2.5 and 4.5 kilograms. Foetal exposure during pregnancy is assessed as not related per company conventions.; Sender's Comments: The neonate's mother was administered the suspect product, Afluria QIV at approximately 16 weeks of gestation (explicitly coded as Foetal exposure during pregnancy'). Reportedly, at 41 weeks of gestation, the subject vacuum-assisted vaginally delivered live birth, male neonate whose birth weight was 4196 grams (coded as large for dates baby). For the event large for dates baby, causal role of the suspect product is assessed as not related due to biological implausibility. Per some sources, the range of normal is between 2.5 and 4.5 kilograms. Foetal exposure during pregnancy is assessed as not related per company conventions.