Sex: M
Vaccine: FLUX
Symptoms: Apgar score normal, Foetal exposure during pregnancy, Large for dates baby
Clinical narrative: Vaccine foetal exposure during pregnancy; Birth weight of 4060 g; This is an observational study case from, initially received from other health professional on 14-Jul-2020, concerning a male neonate whose mother was a 29-year-old, pregnant female subject of body weight: 144.5 lbs, height: 66.3 inches and body mass index (BMI): 23.1, enrolled in, a prospective observational safety study.  The neonate's mother's current condition included vasovagal syncope.  The neonate's mother's concomitant medications included Prenatal + DHA vitamin (ascorbic acid, betacarotene, calcium carbonate, colecalciferol, docosahexaenoic acid, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, riboflavin, thiamine mononitrate, tocopheryl acetate, vitamin B12 nos, zinc oxide) for pregnancy.  The neonate's mother's obstetrical history noted two previous pregnancy that included one spontaneous abortion and one full term live birth. The neonate's mother's had no history of offspring with major congenital malformation (MCM), nor no relevant maternal and paternal medical history. The neonate's mother did not consume tobacco, alcohol or illicit drugs during pregnancy. The neonate's father's age was 30.  The neonate's mother's last menstrual period (LMP) date was 29-Sep-2019. The type of pregnancy was singleton. The neonate's mother's estimated delivery date (EDD) was reported as 25-Jun-2020 and corrected estimated date of delivery (CEDD) was reported as 05-Jul-2020.   On 18-Nov-2019, the neonate's mother underwent ultrasound and no MCM was noted.  On 25-Nov-2019, at approximately 8 weeks of gestation (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 expiration date: not reported] (explicitly coded as 'Foetal exposure during pregnancy') for an influenza immunization.  On 23-Dec-2019, the neonate's mother underwent first trimester screen and ultrasound. No MCM was noted.  On 07-Feb-2020, the neonate's mother underwent ultrasound and no MCM was noted.  On an unspecified date, an unknown amount of time after vaccination, the neonate's mother experienced nausea.   On 16-Mar-2020, the neonate's mother started treatment for nausea with one tablet of Bonjesta (doxylamine succinate, pyridoxine hydrochloride) at a dose of 20 mg, administered orally twice a day.   at gestational age of 40.3 weeks (as reported), the mother vaginally delivered a normal male neonate. The birth weight of neonate was 4060 g. Head circumference was 34 cm and length were 50.8 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 202003650 (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 40.3 weeks of gestation, the subject vaginally delivered male neonate whose birth weight was 4060 grams. 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 8 weeks of gestation. Reportedly, at 40.3 weeks of gestation, the subject vaginally delivered male neonate whose birth weight was 4060 grams. 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.