Sex: M
Vaccine: UNK
Symptoms: Foetal exposure during pregnancy, Intensive care, Respiratory distress, Transposition of the great vessels
Clinical narrative: Respiratory distress; Transposition of great vessels; Foetal exposure during pregnancy; This is a observational study case, initially received on 02-Dec-2019,with additional information received on 04-Dec-2019 (being processed together), concerning a male neonate subject whose mother was a 30-year-old,  of body weight: 261 lbs, height: 65.5 inches and body mass index (BMI): 42.8, who was enrolled in a prospective observational safety study on pregnancy outcomes in women immunized with seasonal cell culture influenza trivalent (TIVc) or quadrivalent (QIVc) vaccine during pregnancy.  The mother's current conditions included body mass index 40 and higher (reported as severely obese), stress and smoking.  The mother's concomitant medication was not provided.  The subject's mother obstetrical history noted that the she had two previous pregnancies, both with full-term live birth. The subject's mother did not have a history of offspring with major congenital malformation (MCM). The mother's family history of major congenital malformation was collected, and the father of baby's maternal nephew had cystic fibrosis. The subject's mother did not use alcohol or illicit drugs during pregnancy. The mother was a user of tobacco. Subject's paternal age was 32.  The subject's mother last menstrual period (LMP) date was 15-Mar-2019. The type of pregnancy was singleton. The mother's estimated delivery date (EDD) was reported as 20-Dec-2019 and corrected EDD was reported as 19-Nov-2019. It was reported that the subject's mother had late entry in prenatal care.   On 02-Jul-2019, the mother underwent anatomy scan and there was no MCM noted.  On 28-Aug-2019 the subject's mother received Tdap [diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid, dose 0.5 mL, route of administration intramuscular] for unknown indication.  On 12-Sep-2019, at gestation age of 25 weeks, the subject's mother was administered Flu Vaccine Cell Subunit QIV NVD [influenza vaccine, batch number: 2612000, dose: 0.5 mL, route of administration, anatomical location, and expiry date: not reported] (explicitly coded as Foetal exposure during pregnancy') for unknown indication.   at gestational age of 40 weeks, the subject's mother vaginally delivered live birth, male neonate with birth weight: 3714 grams. The gestational age at outcome was 40 weeks, body length, head circumference and the appearance, pulse, grimace, activity and respiration (APGAR) were not reported. There was MCM identified at birth as transposition of great vessels.  Other factors contributing to the MCM were unknown. Gestational age range for origin of the defect was three to eight weeks. Ethology of defect was reported as abnormal or absent migration of cardiac neural crest. There had been associations with maternal obesity, smoking and stress. Genetic associations also had been described. As reported, a temporal assessment was that exposure was after the origin of the defect. There was no data about scientific advisory committee (SAC) temporal assessment.  The subject was sent to another medical facility for heart defect. The subject was admitted to neonatal intensive care unit (NICU) due to respiratory distress.   At the time of initial report, the outcome of respiratory distress and transposition of great vessels was not reported.  The event of transposition of great vessels was considered as serious due to criterion of congenital anomaly and medical significance and respiratory distress was considered as serious due to medical significance.  The investigator assessed the transposition of great vessels as not related to Flu Vaccine Cell Subunit QIV NVD, while causality of respiratory distress was not reported.  This case was linked to 201907073, the corresponding maternal pregnancy report.  Company Comment: The male neonate subject was delivered with transposition of the great vessels and developed respiratory distress after foetal exposure during pregnancy with the suspect product Flu Vaccine Cell Subunit QIV NVD at gestation age of 25 weeks. Gestational age range for origin of the defect (transposition of the great vessels) was three to eight weeks, making temporal relationship implausible so causality for the event transposition of the great vessels is assessed as not related. Mother's medical history of severe obesity, stress and tobacco use during pregnancy may provide alternative aetiology for both events. Foetal exposure during pregnancy is assessed as not related per company's conventions. Causality between suspect product and the event respiratory distress is assessed as unlikely related.; Reporter's Comments: The investigator assessed the transposition of great vessels as not related to Flu Vaccine Cell Subunit QIV NVD, while causality of respiratory distress was not reported.; Sender's Comments: The male neonate subject was delivered with transposition of the great vessels and developed respiratory distress after foetal exposure during pregnancy with the suspect product Flu Vaccine Cell Subunit QIV NVD at gestation age of 25 weeks. Gestational age range for origin of the defect (transposition of the great vessels) was three to eight weeks, making temporal relationship implausible so causality for the event transposition of the great vessels is assessed as not related. Mother's medical history of severe obesity, stress and tobacco use during pregnancy may provide alternative aetiology for both events. Foetal exposure during pregnancy is assessed as not related per company's conventions. Causality between suspect product and the event respiratory distress is assessed as unlikely related.