Sex: M
Vaccine: UNK
Symptoms: Apgar score low, Caesarean section, Foetal distress syndrome, Foetal exposure during pregnancy, Macrosomia
Clinical narrative: Macrosomia; Foetal exposure during pregnancy; Fetal intolerance; APGAR score was 1 (one minute) and 6 (five minutes); This is an observational study case, initially received from other health professional on 16-Jan-2020, concerning a male neonate whose mother was 20-year-old, female subject of body weight: 150 lbs, height: 69 inches and body mass index (BMI): 22.1, enrolled in a prospective observational safety study.  The mother's medical history included urinary tract infection, while current conditions included herpes simplex virus 1, anxiety and Streptococcus Group B positive infection.   The mother's concomitant medications included prenatal vitamins (minerals nos; vitamins nos), indication reported as vitamin and Tdap (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid) indication reported as a vaccine. The subject's mother past medications included Menurol (fosfomycin) used for urinary tract infection.  The subject's mother had no previous pregnancies. The subject's mother had no history of offspring with major congenital malformation (MCM) and no relevant maternal and paternal medical history. The subject's mother did not use tobacco, alcohol or illicit drugs during pregnancy.   The mother's last menstrual period (LMP) date was 14-Mar-2019, estimated delivery date (EDD) and corrected estimated date of delivery (CEDD) were reported as 19-Dec-2019. The type of pregnancy was singleton. The subject's father was a 23-year-old.   On 11-Jun-2019, the subject's mother underwent first trimester screen and nuchal translucency screen and no MCM was noted.   On 08-Jul-2019, the subject's mother underwent MSAFP/serum markers analysis and second trimester screen and no MCM was noted.   On 25-Jul-2019, the subject's mother underwent anatomy ultrasound scan and no MCM was noted.   On 18-Oct-2019, at approximately 31 weeks of gestation, the subject's mother was administered Flucelvax TIV (Flu Vaccine Cell Subunit TIV NVD) [influenza vaccine, subunit influenza virus vaccine polyvalent; batch number: 261727; dose: 0.5 ml; route of administration, anatomical location and expiry date: not reported] (explicitly coded as Fetal exposure during pregnancy) for influenza immunisation.   At 40.9 weeks of gestation, the subject's mother delivered live birth, male neonate via caesarean section method. The neonate's birth weight was 4196 g, body length and head circumference were not reported. The appearance, pulse, grimace, activity and respiration (APGAR) score were 1 (one minute), 6 (five minutes) and 8 (ten minutes). There was no MCM identified at birth. Delivery complications included arrest of dilatation, macrosomia and fetal intolerance.  On the same day, the patient recovered from the event of Apgar score low'.  At the time of initial reporting, the outcome of the events macrosomia and fetal intolerance was not reported.  The events of fetal intolerance, macrosomia and APGAR score low' were assessed as serious due to the seriousness criterion of medical significance, per company.   The reporter did not provide causality assessment.  The case is linked to the case 202000269 (the corresponding mother case).  Company comment: Reportedly, abnormal labour affecting foetus, macrosomia and Apgar score low were associated with Flucelvax TIV. The subject's mother was administered vaccine at approximately 31 weeks of gestation. Chronology is plausible. Maternal current conditions, herpes simplex virus 1, anxiety and Streptococcus Group B positive infection may have contributed to development of the events. Causal role of the suspect vaccine cannot be totally excluded and is assessed as unlikely related. Foetal exposure during pregnancy is assessed as unrelated per company's conventions.; Sender's Comments: Reportedly, abnormal labour affecting foetus, macrosomia and Apgar score low were associated with Flucelvax TIV. The subject's mother was administered vaccine at approximately 31 weeks of gestation. Chronology is plausible. Maternal current conditions, herpes simplex virus 1, anxiety and Streptococcus Group B positive infection may have contributed to development of the events. Causal role of the suspect vaccine cannot be totally excluded and is assessed as unlikely related. Foetal exposure during pregnancy is assessed as unrelated per company's conventions.