Sex: F
Vaccine: FLUC4
Symptoms: Apgar score normal, Foetal exposure during pregnancy, Large for dates baby
Clinical narrative: Birth weight 4111g at gestational age 40.1 weeks/Large for gestational age; Fetal exposure during pregnancy; This is a serious spontaneous case, initially received from other health professional on 20-Jun-2019, concerning a female neonate patient.  The patient's mother was a 34-year-old adult female of height 66 inches and weight 140 pounds and body mass index (BMI) 22.6. The mother had 1 previous full term live birth and no birth defects were reported. The mother's family history neither had any major congenital malformations nor offspring with major congenital malformations. The concomitant medications included Prenatal Vitamins (minerals nos;vitamins nos). The last menstrual period (LMP) date of the patient's mother was 04-Aug-2018. The type of pregnancy was singleton. The patient's mother had not used tobacco, alcohol or illicit drugs during current pregnancy. On 19-Sep-2018 and 26-Sep-2019, the patient's mother underwent ultrasound scans and no major congenital malformation was identified.  On 10-Oct-2018, approximately at 9 weeks of gestation, the mother received Flucelvax QIVc (influenza vaccine, subunit influenza virus vaccine polyvalent, cell cultured derived, batch number: 252264, expiry date, dose, anatomical location and route of administration: not reported] for an unknown indication and the fetus was exposed to Flucelvax QIVc via transplacental route (explicitly coded as fetal exposure during pregnancy).  On the same day, the patient's mother underwent ultrasound scan and no major congenital malformation was identified. On 05-Feb-2019, the patient's mother was diagnosed with anemia and was treated with ferrous sulfate (dosing details: 1 tablet twice daily orally, from 05-Feb-2019 to 12-May-2019).   The mother's estimated date of delivery (EDD) and corrected estimated date of delivery (CEDD), both were reported as 11-May-2019.  The mother vaginally delivered a female baby at 40.1 weeks of gestation. The infant's characteristics included, weight 4111. grams (explicitly coded as large for gestational age), body length 54.6 cm and head circumference 33.7 cm. The appearance, pulse, grimace, activity, and respiration (APGAR) scores at 1 minute was 8 and at 5 minutes was 8. There were no pregnancy complications noted. There was no major congenital malformation identified at birth.  This case is linked to 201904017 (the corresponding maternal pregnancy report).; Reporter's Comments: A female neonate was delivered with large for gestational age (weight) after receipt of Flucelvax QIVc at 9 weeks of gestation. The event can be explained by the pregnancy rather than suspect vaccine as there are no known biological mechanism to explain the event. Hence, the causality was assessed as not related to suspect vaccine. The decision to administer a vaccine during pregnancy is related to medical decision making by the mother and her physician and is not related to any property of the medication. The event of foetal exposure during pregnancy was assessed as not related considering the intended use of the vaccine. The company assessed this case as serious (medically significant).