Sex: M
Vaccine: FLU4
Symptoms: Apgar score low, Caesarean section, Foetal distress syndrome, Foetal exposure during pregnancy, Maternal condition affecting foetus
Clinical narrative: Fetal Intolerance of labor; APGAR score: One minute: 1; Fetal exposure during pregnancy; This is a serious spontaneous case, initially received from other health professional on 27-Jun-2019, concerning a male neonate patient.  The patient's mother was a 29-year-old female of weight: 263.8 lbs, height: 62.8 cm and body mass index (BMI): 47. The patient's mother had 3 previous pregnancies and the patient's mother had elective abortions in all the previous pregnancies. The patient's mother had paternal history of extra digits (toes and fingers) in the family history of baby's father. The patient's mother had no history of offspring with major congenital malformation. Also, the patient's mother had no maternal history with major congenital malformations. The patient's mother current condition included asthma, depression and anxiety (since an unspecified date). The patient's mother concomitant medications included Prenatal vitamins with DHA (ascorbic acid, betacarotene, calcium carbonate, colecalciferol, docosahexaenoic acid, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, riboflavin, thiamine mononitrate, tocopheryl acetate, vitamin b12 nos, zinc oxide) for pregnancy and albuterol sulfate for asthma.  The last menstrual period (LMP) date of the patient's mother was 03-Sep-2018. The type of pregnancy was singleton. The patient's mother did not consume tobacco or alcohol during her current pregnancy.  On 29-Oct-2018, the patient's mother underwent ultrasound, and no major congenital malformation was noted.  On 05-Nov-2018, at gestational age of approximately 9 weeks, the patient was exposed to Afluria Quadrivalent (influenza vaccine, dose, route of administration: transplacental route, anatomical location, batch number and expiry date: not reported) (explicitly coded as foetal exposure during pregnancy) for an unknown indication.   On the same day, the patient's mother underwent prenatal bloodwork and no major congenital malformation was noted. On 15-Nov-2018, the patient's mother underwent Papanicolaou test (PAP) smear and cultures, Neisseria gonorrhoeae (GC), chlamydia and no major congenital malformation was noted. On 26-Nov-2018, the patient's mother underwent first trimester screen and no major congenital malformation was noted. On 21-Jan-2019, the patient's mother underwent ultrasound, and no major congenital malformation was noted.  At gestational age of 38.4 weeks, live normal male baby was delivered via caesarean and spontaneous rupture of membranes (SROM), induction of labor, fetal intolerance and prolonged rupture of membrane (ROM) were observed as pregnancy complications. The birth weight of the baby was 2790 grams, head circumference was 35.5 cm and length was 52 cm. Appearance, pulse, grimace, activity and respiration (APGAR) score at one minute was 1 (explicitly coded as APGAR score low), at five minutes was 8 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) was reported as 10-Jun-2019.  The outcome of the event fetal distress was not reported and outcome for the event APGAR score low was recovered on 30-May-2019.   This case is linked to case 201805304 (mother case).; Reporter's Comments: A male neonate experienced foetal distress with low APGAR score at the time of delivery at 38 weeks, after exposure to Afluria QUAD at 9 weeks of gestation. The delivery was associated with prolonged rupture of membrane, which can explain the events rather than suspect vaccine. Hence, causality assessed as not related to suspect vaccine.  The company assessed the case as serious (medically significant).