Sex: M
Vaccine: FLUC4
Symptoms: Apgar score normal, Foetal exposure during pregnancy, Large for dates baby
Clinical narrative: Birth weight (g): 4054/Large for gestational age; Foetal exposure during pregnancy; This is a serious spontaneous case, initially received from other health professional on 02-Jul-2019, concerning a male neonate patient.  The patient's mother was a 29-year-old female of height 64 inches, body weight 142 lbs and body mass index (BMI): 24.4. The patient's mother did not have previous pregnancies. On an unknown date, the patient's mother family history of major congenital malformation was collected, and the patient's mother had no maternal or paternal history with major congenital malformations. The patient's mother concomitant medications included Prenatal vitamin (minerals NOS and vitamins NOS) for pregnancy.  The patient's mother last menstrual period (LMP) date was 11-Sep-2018. The type of pregnancy was singleton. The patient's mother did not consume tobacco, alcohol or illicit-drugs during pregnancy.  On 17-Oct-2018, the patient's mother underwent Hgb (haemoglobin) electrophoresis, spinal muscular atrophy screening, fibrosis mutation analysis and no major congenital malformations were noted.   On 29-Oct-2018, at gestational age of approximately 6 weeks, the patient was exposed to Flucelvax QIVc(influenza vaccine, subunit influenza virus vaccine polyvalent, batch number: 252664, route of administration: transplacental, dose, anatomical location and expiry date: not reported) (explicitly coded as fetal exposure during pregnancy) for an unknown indication.   On the same day, after vaccination, the patient's mother was noted to have acne and was treated with Clindagel (clindamycin phosphate, rn, topically, from 29-Oct-2018 to 08-Dec-2018) for acne.   On 30-Oct-2018, the patient's mother had undergone ultrasound scanning and no major congenital malformations were noted.   On 25-Jun-2019, at gestational age of 41 weeks, live normal male patient was delivered via vaginal delivery and no pregnancy complications were noted. The birth weight of the foetus was 4054 grams (explicitly coded as large for gestational age), head circumference was 36.2 cm and length was 54.6 cm. Appearance, pulse, grimace, activity and respiration (APGAR) score at one minute was 8, at five minutes was 9 and no data was reported for APGAR score at ten minutes. No major congenital malformation was identified at birth.  The patient's mother estimated delivery date (EDD) and corrected estimated delivery date (CEDD) were reported as 18-Jun-2019.  This case is linked to a case 201904082 (mother case).; Reporter's Comments: A male neonate patient was diagnosed with large for gestational age (LGA) at birth, after maternal receipt of Flucelvax QIVc vaccine at approximately 6 weeks of gestation (considered as foetal exposure during pregnancy). The known aetiologies of LGA includes genetic, increased maternal weight gain during pregnancy and maternal gestational diabetes. Considering the lack of biological evidence associated with suspect vaccine, the causality of event LGA assessed as not related. The event foetal exposure during pregnancy assessed as not related considering the intended use of vaccine. The company assessed the case as serious (medically significant).