Sex: M
Vaccine: TDAP, UNK
Symptoms: Apgar score normal, Caesarean section, Foetal exposure during pregnancy, Low birth weight baby
Clinical narrative: Foetal exposure during pregnancy; Low birth weight; This is an observational study case, initially received from other health professional on 17-Jan-2020, concerning a male neonate, whose mother was a 24-year-old, pregnant, female subject of body weight 189 lbs, height 64.8 inches and body mass index (BMI) 31.6, 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 subject's mother past drug included methylprednisolone for migraine.  The subject's mother current conditions included obesity, migraine, recurrent urinary tract infection, polycystic ovaries, low back pain, gastroesophageal reflux disease (GERD). The subject's mother was rubella and varicella non-immune.  The subject's mother concomitant medications included cyclobenzaprine for migraine, vitamins nos as supplement, Protonix (omeprazole), pantoprazole, metoclopramide, omeprazole and ranitidine, all for GERD.  The subject mother obstetrical history included one previous pregnancy with one spontaneous abortion. 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 subject mother's last menstrual period (LMP) date was 10-Apr-2019. Estimated delivery date (EDD) was 15-Jan-2020 and corrected delivery date (CEDD) was 23-Jan-2020. The pregnancy was singleton and complicated with pre-eclampsia. The subject's father was 26-year-old.  On 02-Jul-2019, the subject's mother initial ultrasound test and no MCM was noted.  On 16-Jul-2019, the subject's mother underwent ultrasound  nuchal translucency (NT) and first trimester screen and no MCM was noted.  On 20-Aug-2019, the subject's mother underwent second trimester screen and maternal serum alpha fetoprotein (MSAFP) / serum markers and no MCM was noted.  On 27-Aug-2019, the subject's mother underwent ultrasound - anatomy and no MCM was noted.  On 05-Nov-2019, at gestational age of 29 weeks, the subject's mother was administered Flucelvax QIVc( Flu Vaccine Cell Subunit QIV NVD) [influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, batch number: 261223, anatomical location, route of administration and expiration date: not reported] (explicitly coded as Foetal exposure during pregnancy') for an influenza immunisation.  On the same day, the subject's mother was administered non-company co-suspect TDAP vaccine [diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid; dose: 0.5 ml, route of administration: intramuscular, batch number, anatomical location and expiration date: not reported] as vaccine.  At gestational age of 37 weeks, the subject's mother delivered live birth, male neonate by caesarean delivery. The neonate's birth weight was 2339 g, his head circumference and length were not provided. The appearance, pulse, grimace, activity, and respiration (APGAR) scores were 8 (one minute) and 9 (five minutes). There was no MCM identified at birth.   At the time of initial reporting, the outcome of the event low birth weight baby was not reported.   The event of low birth weight baby was assessed as serious due to criterion of medical significance, per company.  The causality assessment was not provided.  The case is linked to case 202000474, the corresponding mother case.  Company Comment: The male neonate subject was delivered as low birth weight baby after foetal exposure during pregnancy, at gestation age of 29 weeks with the suspect product Flucelvax QIVc. Chronology is plausible. Mother's medical history of obesity (body mass index 31.6) and pre-eclampsia may provide alternative aetiology for the event. Causality is also confounded by therapy with multiple concomitant medications and non-company co-suspect TDAP vaccine (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid). Foetal exposure during pregnancy is assessed as not related per company's conventions. Causality between suspect product and the event low birth weight baby is assessed as not related.; Sender's Comments: The male neonate subject was delivered as low birth weight baby after foetal exposure during pregnancy, at gestation age of 29 weeks with the suspect product Flucelvax QIVc. Chronology is plausible. Mother's medical history of obesity (body mass index 31.6) and pre-eclampsia may provide alternative aetiology for the event. Causality is also confounded by therapy with multiple concomitant medications and non-company co-suspect TDAP vaccine (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid). Foetal exposure during pregnancy is assessed as not related per company's conventions. Causality between suspect product and the event low birth weight baby is assessed as not related.