Sex: F
Vaccine: FLUX, TDAP
Symptoms: Abnormal labour affecting foetus, Apgar score normal, Caesarean section, Foetal exposure during pregnancy
Clinical narrative: Foetal exposure during pregnancy; Fetal intolerance of labor; This is an observational study case, initially received from other health professional on 14-Jan-2020 concerning a female, neonatal subject. The subject's mother was 30-year-old, pregnant, female of body weight: 148 Ibs, height: 64 in and body mass index (BMI) 25.4 enrolled in a prospective observational safety study.  The subject's mother relevant medical history was not reported.   The subject's mother concomitant medication included Prenatal vitamins (unspecified vitamins and minerals) as vitamin.  The subject's mother had two previous pregnancies which included one full term live birth and one spontaneous abortion. The subject's mother had a cousin with major congenital malformation (MCM) reported as tetrology of Fallot. The subject had no paternal history with MCM. The subject's mother had no history of offspring with MCM. The subject's mother did not use tobacco, alcohol or illicit drugs during pregnancy.  The subject's mother last menstrual period (LMP) date was 26-Mar-2019. Estimated delivery date (EDD) was reported as 31-Dec-2020 and corrected estimated delivery date (CEDD) was not reported. The type of pregnancy was singleton and the pregnancy was complicated by 20% abruption of placenta. The subject's father was 35-year-old.  On 04-Oct-2019, at approximately 27 weeks of gestation, the subject's mother was administered Flucelvax QIV (Flu Vaccine Cell Subunit QIV NVD) [influenza vaccine, subunit influenza virus vaccine polyvalent, batch number: 261727, dose, route of administration, anatomical location 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, anatomical location, batch number and expiration date: not reported] as vaccine.  At approximately 39.3 weeks of gestation, the mother gave a live birth to female neonate by cesarean method. The characteristics of the neonate included weight: 2889 grams, head circumference and length were not reported. During delivery, the subject experienced fetal intolerance of labor. Appearance, pulse, grimace, activity, and respiration (APGAR) scores were 9 at one minute and 9 at five minutes. The APGAR score at 10 minutes was not reported. No MCMs were identified at the time of birth.  At the time of initial reporting, the outcome of the event of 'abnormal labour affecting foetus' was not reported.  The event of 'abnormal labour affecting foetus' was considered as serious due to the criterion of medical significance.  The reporter did not provide causality assessment to Flucelvax QIVc.  This case is linked to case 202000132 (the corresponding mother case).  Company Comment: The female neonate subject experienced abnormal labour affecting foetus after foetal exposure during pregnancy, at gestation age of 27 weeks with the suspect product Flucelvax QIV. Chronology is plausible. Mother's medical history of 20% abruption of placenta may provide alternative aetiology for the event. Causality is also confounded with co-suspect product Tdap (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 abnormal labour affecting foetus is assessed as unlikely related (defaults to related for reporting purposes).; Sender's Comments: The female neonate subject experienced abnormal labour affecting foetus after foetal exposure during pregnancy, at gestation age of 27 weeks with the suspect product Flucelvax QIV. Chronology is plausible. Mother's medical history of 20% abruption of placenta may provide alternative aetiology for the event. Causality is also confounded with co-suspect product Tdap (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 abnormal labour affecting foetus is assessed as unlikely related (defaults to related for reporting purposes).