Sex: F
Vaccine: FLUX
Symptoms: Foetal exposure during pregnancy, Large for dates baby
Clinical narrative: Fetal exposure during pregnancy; Birth weight of 4366 g; This observational study case, initially received on 23-Feb-2021 from other health professional and concerned a female neonate patient, whose mother was 31-year-old, pregnant subject of body weight 174 lbs, height 62 inches and body mass index (BMI) 31.8; enrolled in, a prospective observational safety study.  The maternal medical history included high BMI, nausea and vomiting. The maternal concomitant medications included Prenatal vitamins (unspecified minerals and vitamins) for pregnancy and ondansetron for nausea and vomiting.  The neonate's mother's obstetrical history included one previous pregnancy with spontaneous abortion. The neonate's mother had no history of offspring with major congenital malformation (MCM) and no maternal and paternal history with MCM. The neonate's mother did not use tobacco, alcohol or illicit drugs during pregnancy.  The neonate's mother's last menstrual period (LMP) was reported as 11-Oct-2019. The mother's estimated delivery date (EDD) was reported as 17-Jul-2020 and corrected estimated date of delivery (CEDD) was not reported. The type of pregnancy was singleton.  On 09-Dec-2019, the ultrasound revealed no MCM.   On 06-Jan-2020, at approximately 12 weeks of gestation (calculated pet LMP), the neonate's mother was administered 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. Batch number reported was  P100112488.   On 03-Feb-2020, the gender ultrasound scan revealed no MCM.  At gestational age of 41 week (as reported), the mother vaginally delivered live female neonate. The neonate's birth weight was 4366 grams, head circumference and body length were not reported. The appearance, pulse, grimace, activity, and respiration (APGAR) score at one minute, at five minutes and at 10 minutes were not provided. There was no MCM noted at birth.   The outcome of the event 'high birthweight baby' was not reported.  The reporter did not provide 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 case 202003732, due to corresponding mother 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 12 weeks. Neonate's weight on birth was 4366 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 12 weeks. Neonate's weight on birth was 4366 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.