Sex: F
Vaccine: UNK
Symptoms: Apgar score normal, Caesarean section, Foetal exposure during pregnancy, Large for dates baby
Clinical narrative: Vaccine foetal exposure during pregnancy; Birth weight of 4167 g; This is a observational study case, reported by other health professional and initially received on 14-Jul-2020, concerning a female neonate whose mother was 25-year-old, pregnant female subject,  of body weight: 277.5 lbs, height: 65.3 inches and body mass index (BMI): 45.8, who was enrolled in a prospective observational safety study on pregnancy outcomes in women immunized with Afluria QIV, a seasonal quadrivalent vaccine, during pregnancy.  The neonate's mother's medical history included rhesus factor (RhD) negative, history of pregnancy induced hypertension and high body mass index.  The neonate's mother's concomitant medications included Prenatal vitamin (unspecified minerals and vitamins) and folic acid, both for pregnancy, vitamin D3 as health supplementation and Aspirin (acetylsalicylic acid) for history of pregnancy induced hypertension.  The neonate's mother's obstetrical history noted two previous pregnancies which included one full-term live birth and one spontaneous abortion. The neonate's mother had no history of offspring with major congenital malformation (MCM), nor relevant maternal or paternal history. The neonate's mother did not consume tobacco, alcohol or illicit drugs during pregnancy. The neonate's father's age was 40.  The neonate's mother last menstrual period (LMP) date was 24-Sep-2019, the estimated delivery date (EDD) was 30-Jun-2020 and corrected estimated date of delivery (CEDD) was reported as 05-Jul-2020. The type of pregnancy was singleton.   On 11-Nov-2019, the neonate's mother underwent ultrasound and no MCM was noted.  On 20-Nov-2019, at gestational age of 8 weeks (calculated per LMP), the neonate's mother was administered Afluria QIV (Flu Vaccine Egg Split QIV CSL) [influenza vaccine, batch number: P100126099, dose, route of administration, anatomical location and expiry date: not reported] (explicitly coded as Foetal exposure during pregnancy') for influenza immunisation.  On an unspecified date, an unknown amount of time after vaccination, the neonate's mother experienced nausea.   On 30-Jan-2020 and 17-Feb-2020, the neonate's mother underwent ultrasound and no MCM was noted.  On 27-Feb-2020, the neonate's mother started treatment for nausea with one tablet of Zofran (ondansetron hydrochloride) at a dose of 8 mg, administered via oral route, every eight hours as needed.  On 02-Mar-2020, three months and 11 days after vaccination, the neonate's mother developed gestational diabetes.   On 16-Mar-2020, the neonate's mother underwent ultrasound and no MCM was noted.  At gestational age of 39.3 weeks (as reported), the mother delivered a normal female neonate by caesarean method. The birth weight of neonate was 4167 g. Head circumference was 35 cm and length were 53.3 cm. Appearance, pulse, grimace, activity and respiration (APGAR) score at one minute was 8 and at five minutes was 9. APGAR score for 10 minutes was not provided.  No pregnancy complications were noted. No MCM was identified at birth.  At the time of initial report, the outcome of 'high birthweight baby' was not reported.  Per company, the event of high birthweight baby' was assessed as serious due to criterion of medically significance.  The reporter did not provide a causality assessment to Afluria QIV.  This case is linked to case 202002644 (the corresponding mother case).  Company comment: The neonate's mother was administered the suspect product, Afluria QIV at approximately 8 weeks of gestation. Reportedly, at 39.3 weeks of gestation, the subject delivered female neonate whose birth weight was 4167 grams. For the event large for dates baby, causal role of the suspect product is assessed as not related due to biological implausibility. Mother's medical history of pregnancy induced hypertension and high body mass index may have contributed to development of the event. 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 8 weeks of gestation. Reportedly, at 39.3 weeks of gestation, the subject delivered female neonate whose birth weight was 4167 grams. For the event large for dates baby, causal role of the suspect product is assessed as not related due to biological implausibility. Mother's medical history of pregnancy induced hypertension and high body mass index may have contributed to development of the event. 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.