Sex: F
Vaccine: FLUX
Symptoms: Apgar score normal, Foetal exposure during pregnancy, Large for dates baby
Clinical narrative: Foetal exposure during pregnancy; Body weight at birth 4179 g; This observational study case was received on 22-Jan-2021 from other health professional and concerned a female neonate patient, whose mother was 25-year-old, pregnant subject of body weight: 297 lbs, height: 67.5 inches and body mass index (BMI): 45.8, enrolled in, a prospective observational safety study.   The neonate's mother's concurrent conditions included polycystic ovary syndrome and obesity. The mother's concomitant medication included Prenate Mini Vitamin (folic acid, iron, eicosapentaenoic acid, docosahexaenoic acid, vitamin D, vitamins B6, B7, B9 and B12, iodine, and magnesium) for pregnancy.  The mother's obstetrical history included one previous pregnancy with full term live birth. The mother had no history of offspring with major congenital malformation (MCM). The patient's mother had no maternal or paternal history with MCM.   The mother's last menstrual period (LMP) date was 15-Jan-2020, estimated delivery date (EDD) was reported as 22-Oct-2020 and corrected estimated date of delivery (CEDD) was reported as 08-Jan-2021. The type of pregnancy was singleton. The patient's mother did not use alcohol or illicit drugs during pregnancy. The neonate's mother's smoked two to three cigarettes per day during pregnancy until May-2020.  On 28-Jul-2020 and 18-Aug-2020, the ultrasound revealed no MCM.  On 02-Sep-2020, at gestational age of 33 weeks (calculated per LMP), the neonate's mother was vaccinated with Afluria QIV (Flu Vaccine Egg Split QIV CSL) (influenza vaccine; dose, route of administration and anatomical location: not reported) (explicitly coded as 'Foetal exposure during pregnancy') for influenza immunisation. The batch number was P100230203.   On the same day, ultrasound revealed no MCM.  At gestational age of 39.4 weeks (as reported), the mother vaginally delivered live female neonate. The neonate birth weight was 4179 g, head circumference 34.5 cm and length 54.6 cm. The appearance, pulse, grimace, activity and respiration (APGAR) scores were 7 (one minute) and 9 (five minutes). No data was reported for APGAR score at ten minutes. No MCM was identified at birth.   The outcome of the event was unknown.  The reporter did not provide a causality assessment.  The event of 'high birthweight baby' was considered to be medically significant by a Physician within Seqirus's Pharmacovigilance and Risk Management Department.  This case is linked with the case 202005288, corresponding mother's case.  Company comment: A female neonate was exposed to the suspect product, Afluria QIV. The neonate's mother was vaccinated with Afluria QIV at gestational age of 33 weeks. Neonate's weight on birth was 4179 grams. Causality between suspect product and event of large for dates baby 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's conventions.; Sender's Comments: A female neonate was exposed to the suspect product, Afluria QIV. The neonate's mother was vaccinated with Afluria QIV at gestational age of 33 weeks. Neonate's weight on birth was 4179 grams. Causality between suspect product and event of large for dates baby 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's conventions.