Sex: F
Vaccine: FLUC4
Symptoms: Apgar score normal, Foetal exposure during pregnancy, Low birth weight baby, Premature baby
Clinical narrative: Preterm birth/gestational age at outcome (weeks); 35.3/premature birth; Birth weight (g): 2296/Low birth weight/Low birth weight baby; Fetal exposure during pregnancy; This is a serious spontaneous case, initially received from other health professional on 16-Jul-2019, concerning a female neonate patient.   The patient's mother was 27-year-old female, with no obstetrical history. The mother had no family history of offspring with major congenital malformation. No relevant maternal and paternal medical history with major congenital malformation. The mother used alcohol during pregnancy and the amount of consumption was reported as less than 2 drinks per day. The mother did not use tobacco and illicit drugs during pregnancy. The mother's current condition included alcohol user and anxiety. The mother's concomitant medications included Prenatal vitamins (minerals NOS, vitamins NOS) for pregnancy and Inderal (propranolol hydrochloride) for anxiety.  The mother's last menstrual period (LMP) date was 25-Aug-2018 and type of pregnancy was singleton.  On 19-Oct-2018, at gestational age of approximately 7 weeks, the foetus was exposed to Flucelvax QIVc [influenza vaccine, subunit influenza virus vaccine polyvalent, cell-culture-derived, batch number: 252664, route of administration: trans placental, dose, anatomical location, and expiry date: not reported] (explicitly coded as foetal exposure during pregnancy) for an unknown indication.  On 12-Feb-2019, after administration of vaccine, the patient's mother experienced anaemia and was recovered on 29-Apr-2019.  6 months and 10 days after vaccination, a live normal female neonate was delivered at 35.3 weeks of gestational age (explicitly coded as premature birth) via vaginal method. At the time of delivery, the mother had pre-eclampsia as pregnancy complication. The neonate's birth weight was 2296 grams (explicitly coded as low birth weight baby), head circumference: 31.8 centimetres and body length: 48.9 centimetres. The appearance, pulse, grimace, activity, and respiration (APGAR) scores were 8 at one minute, 9 at five minutes and there was no data for 10 minutes. There was no major congenital malformation was identified at birth.   The estimated delivery date (EDD) patient's mother was reported as 01-Jun-2019.   The outcome of the events was unknown.   This case is linked to 201904146 (mother case).; Reporter's Comments: A female neonate was delivered at 35.3 weeks of gestational age (explicitly coded as premature birth) and was considered as low birth weight baby, 6 months 10 days after administration of study vaccine given at 7 weeks of gestation age (explicitly coded as foetal exposure during pregnancy). Considering the unlikely timeframe of events with respect to vaccine administration, no evidence for a biological mechanism that could cause the events and risk factors (alcohol user and anxiety treated with propranolol hydrochloride), the events (premature birth and low birth weight baby) were assessed as not related to the vaccination. 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 the case as serious (medically significant).