Sex: F
Vaccine: FLUX, TDAP
Symptoms: Apgar score normal, Foetal exposure during pregnancy, Grunting, Hypoglycaemia, Intensive care
Clinical narrative: Grunting; Hypoglycemia; Foetal exposure during pregnancy; Preterm birth at gestational age of 36.7 weeks; This is an observational study case, initially received from other health professional on 20-Jan-2020, concerning a female neonate whose mother was 29-year-old, female subject of body weight: 190 lbs, height: 65 inches and body mass index (BMI): 31.6, enrolled in a prospective observational safety study.   The mother's medical history included intrauterine insemination, anxiety, depression, nausea and obesity with BMI 31.6.  The mother's past medications included Femara (letrozole) for an unknown indication, while the mother's concomitant medications included prenatal vitamins (unspecified vitamins and minerals) as vitamin, lamotrigine for anxiety and depression, Bonjesta (doxylamine succinate, pyridoxine hydrochloride) and promethazine for nausea.   The subject's mother obstetrical history included one previous spontaneous abortion. The subject's mother had no history of offspring with major congenital malformation (MCM). Also, the mother had maternal history with MCM which included her mother with heart defect. The mother had no paternal history with MCM. The mother did not use tobacco, alcohol or illicit drugs during pregnancy. The pregnancy was complicated by pre-eclampsia in third trimester.  The mother's last menstrual period (LMP) date was 28-Mar-2019, estimated delivery date (EDD) and corrected estimated date of delivery (CEDD) were reported as 02-Jan-2020. The type of pregnancy was singleton. The subject's father was a 29-year-old.   On 11-Jun-2019, the subject's mother underwent maternity 21 test and no MCM was noted.   On 22-Jul-2019, the subject's mother underwent maternal serum alpha-fetoprotein (MSAFP) / serum markers analysis and second trimester screen and no MCM was noted.   On 13-Aug-2019, the subject's motherunderwent anatomy scan and no MCM was noted.   On 09-Oct-2019, at approximately 27 weeks of gestation, the subject's mother was administered Flucelvax QIV (Flu Vaccine Cell Subunit TIV NVD) [influenza vaccine, subunit influenza virus vaccine polyvalent; batch number: 261215; dose: 0.5 ml; route of administration, anatomical location and expiry date: not reported] (explicitly coded as Fetal exposure during pregnancy) for 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, anatomical location, batch number and expiry date: not reported] as vaccine.  At 36.7 weeks of gestation the subject's mother vaginally delivered live birth, female neonate. The neonate's birth weight was 3402 g, body length and head circumference were not reported. The appearance, pulse, grimace, activity and respiration (APGAR) score were 8 (one minute), 9 (five minutes) and in ten minutes was not reported. There was no MCM identified at birth.  On an unspecified date in Dec-2019, the subject developed grunting and hypoglycaemia and was admitted in neonatal intensive care unit (NICU) for observation.  At the time of initial reporting, the outcome of the events premature baby, grunting and hypoglycaemia was not reported.   The event of 'birth premature' was assessed as serious due to the criterion of medically significance.   The reporter did not provide causality assessment.  The case is linked to the case 202000576 (the corresponding mother case).  Company Comment: The female neonate subject was delivered as premature baby and experienced grunting and hypoglycaemia after foetal exposure during pregnancy with the suspect product, Flucelvax QIV at approximately 27 weeks of gestation. Chronology is plausible. Mother's medical history of one previous spontaneous abortion, obesity (body mass index 31.6) and non-company co-suspect Tdap vaccine (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid) may provide alternative aetiology for the events. Causality is also confounded by therapy with mother's concomitant medication, Bonjesta (doxylamine succinate, pyridoxine hydrochloride), lamotrigine and promethazine. Causality between suspect product and the events premature baby, grunting and hypoglycaemia is assessed as unlikely related (defaults to related for reporting purposes). Foetal exposure during pregnancy is assessed as not related to the suspect vaccine per company's conventions.; Sender's Comments: The female neonate subject was delivered as premature baby and experienced grunting and hypoglycaemia after foetal exposure during pregnancy with the suspect product, Flucelvax QIV at approximately 27 weeks of gestation. Chronology is plausible. Mother's medical history of one previous spontaneous abortion, obesity (body mass index 31.6) and non-company co-suspect Tdap vaccine (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid) may provide alternative aetiology for the events. Causality is also confounded by therapy with mother's concomitant medication, Bonjesta (doxylamine succinate, pyridoxine hydrochloride), lamotrigine and promethazine. Causality between suspect product and the events premature baby, grunting and hypoglycaemia is assessed as unlikely related (defaults to related for reporting purposes). Foetal exposure during pregnancy is assessed as not related to the suspect vaccine per company's conventions.