Sex: M
Vaccine: FLU4
Symptoms: Apgar score low, Caesarean section, Endotracheal intubation, Foetal exposure during pregnancy, Foetal heart rate deceleration abnormality
Clinical narrative: Fetal exposure during pregnancy; Hypoxic ischemic encephalopathy; Prolonged deceleration of fetal heart rate during labor; APGAR score at one minute was 0, at five minutes 0, at 10 minutes 2, at 15 minutes 3, at 20 minutes 3; This is an observational study case, initially received from other health professional on 08-Jun-2020 with two additional documents received on 09-Jun-2020 and 10-Jun-2020 (being processed together), concerning a male foetus whose mother was 36-year-old female pregnant subject of body weight 122.5 lbs, height 63 inches and body mass index (BMI) 21.7 and enrolled in, a prospective observational safety study on pregnancy outcomes in women immunized with Afluria QIV, a seasonal quadrivalent vaccine, during pregnancy.  The foetus mother's medical history included migraine and advanced maternal age.  The foetus mother's concomitant medication included Prenatal gummy (unspecified minerals and vitamins) for pregnancy, iron as supplement and Tylenol (paracetamol) for migraine.   The foetus mother's obstetrical history included five previous pregnancies, with five full term live births. The foetus mother had no maternal or paternal history with major congenital malformations (MCMs). Also, the foetus mother had no history of offspring with MCM. The foetus mother did not use tobacco, alcohol or illicit drugs during pregnancy.  The foetus mother's last menstrual period (LMP) was on 13-Aug-2019. The foetus mother's estimated delivery date (EDD) and corrected estimated date of delivery (CEDD) were reported as 19-May-2020. The type of pregnancy was singleton. The foetus father was 35-year-old.  On 22-Oct-2019, the foetus mother underwent ultrasound and no MCMs were noted.  On 29-Oct-2019, at approximately 11 weeks of gestation (calculated per LMP), the foetus 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 immunisation.   On 24-Dec-2019, the foetus mother underwent ultrasound and no MCMs were noted.  at 40.3 weeks of gestation (as reported), the foetus mother delivered a live male neonate via caesarean method of delivery. The neonate's birth weight was 3450 grams, body length was 50 cm and head circumference was 35.5 cm. The neonate experienced hypoxic ischemic encephalopathy as MCM. The appearance, pulse, grimace, activity, and respiration (APGAR) score at one minute was 0, at five minutes was 0, at 10 minutes was 2, at 15 minutes was 3 and at 20 minutes was 3. As reported, organ system for identified MCM hypoxic ischaemic encephalopathy was central nervous system (CNS). Etiology was often attributed to inadequate foetal oxygenation around the time of birth. Exact gestational age range for origin of the defect, confounding factors and temporal assessment were not reported. Additional details clarified that infant required intubation, chest compression, epinephrine and body cooling. These conditions was attributed to prolonged deceleration of foetal heart rate during labour and thick meconium. The signs of defect first presented at birth.   At the time of initial reporting, the outcome for the event of 'hypoxic-ischaemic encephalopathy', 'fetal heart rate deceleration'  and APGAR score low' was not reported.  The event of 'hypoxic-ischaemic encephalopathy' was assessed as serious due to seriousness criterion of congenital anomaly and medical significance, while the event 'APGAR score low' and 'fetal heart rate deceleration' were assessed as serious due to seriousness criterion of medical significance.  The causality assessment was not provided.  This case is linked to the case 202002777 (the corresponding mother's case).  Company Comment: A male neonate experienced the events of hypoxic ischemic encephalopathy, foetal heart rate deceleration abnormality and Apgar score low, 6 months and 22 days after foetal exposure to the suspect product Afluria QIV. The neonate's mother was administered vaccine at approximately 11 weeks of gestation. Causal role of the suspect product is assessed as not related for all events, due to biological implausibility and unsuggestive chronology. Causality was confounded by advanced maternal age. Foetal exposure during pregnancy is assessed as not related per company conventions.; Sender's Comments: A male neonate experienced the events of hypoxic ischemic encephalopathy, foetal heart rate deceleration abnormality and Apgar score low, 6 months and 22 days after foetal exposure to the suspect product Afluria QIV. The neonate's mother was administered vaccine at approximately 11 weeks of gestation. Causal role of the suspect product is assessed as not related for all events, due to biological implausibility and unsuggestive chronology. Causality was confounded by advanced maternal age. Foetal exposure during pregnancy is assessed as not related per company conventions.