Sex: F
Vaccine: FLUC4
Symptoms: Apgar score low, Foetal exposure during pregnancy
Clinical narrative: Apgar score: one minute: 2/Apgar score decreased; Foetal exposure during pregnancy; This is a serious spontaneous case, initially received from other health professional on 19-Jun-2019, concerning a female neonate patient.   The patient's mother was 33-year-old with obstetrical history included two previous pregnancies in which both were full term live births and there were no birth defects reported. The patient's mother did not have history of offspring with major congenital malformation and no relevant maternal and paternal medical history. The concomitant medications of the patient's mother included Prenatal vitamins (minerals nos, vitamins nos) for pregnancy as a supplement. The pregnancy status of the patient's mother was collected, and no pregnancy complications were noted.  The last menstrual period (LMP) date of the patient's mother was 07-Sep-2018. The type of pregnancy was singleton. The patient's mother did not use tobacco, alcohol or illicit drugs during pregnancy.   On 14-Nov-2018, the panorama prenatal test of the patient's mother was performed, and no major congenital malformation was noted.  On 24-Jan-2019, at gestational age of approximately 19 weeks, the foetus was exposed to Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent, route of administration: transplacental, batch number: 252675, dose, anatomical location and expiry date: not reported) (explicitly coded as foetal exposure during pregnancy) for an unknown indication.   On an unspecified date, after the vaccine administration, the patient's mother experienced heartburn and was treated with Prilosec (omeprazole) (dose: 1 tablet, prn, orally from 22-May-2019) and Tums (calcium carbonate) (dose: 1 tablet, prn, orally from 22-May-2019) for heartburn.  At gestational age 39.9 weeks, the mother gave a live birth to a normal female neonate via vaginal method of delivery. The characteristics of the neonate included birth weight: 3690 grams. The head circumference: no data, body length: no data and appearance, pulse, grimace, activity, and respiration (APGAR) scores were 2 (one minute) (explicitly coded as Apgar score decreased), 9 (five minutes). No other pregnancy complications and major congenital malformation (MCM) were not identified at birth.  The estimated date of delivery (EDD) and corrected estimated date of delivery (CEDD) of the patient's mother was reported as 14-Jun-2019.  This case is cross-linked to the case: 201903626 (mother case).; Reporter's Comments: A female neonate patient born at 39.9 weeks of gestation was found to have one minute APGAR score of 2, following vaccination with Flucelvax QIVc at 19 weeks. The event can be explained by the delivery related process rather than suspect vaccine. Hence, the causality 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)