Sex: F
Vaccine: UNK
Symptoms: Apgar score abnormal, Foetal exposure during pregnancy, Shoulder dystocia
Clinical narrative: Vaccine fetal exposure during pregnancy; Shoulder dystocia labour complication; This is an observational study case, initially received from other health professional on 20-Jan-2020, concerning a female neonate subject, whose mother was 22-year-old, pregnant subject of body weight: 156 lbs, height: 63.6 inches and body mass index (BMI): 27.1 enrolled in a prospective observational safety study.  The mother's medical history included increased body mass index and congestion.  The mother's concomitant medications included fluticasone propionate for congestion and unspecified vitamins as obstetrics (OB) supplements.  The mother did not have any previous pregnancies, nor maternal and paternal history with major congenital malformation (MCM). The mother did not consume tobacco, alcohol and illicit-drugs during pregnancy.  The mother's last menstrual period (LMP) date was 23-Mar-2019. The mother's estimated date of delivery (EDD) was 28-Dec-2019 and corrected estimated date of delivery (CEDD) was 06-Jan-2020. The type of pregnancy was singleton. The father's age was 23.  On 30-May-2019, the subject's mother underwent ultrasound and no MCM was noted.  On 26-Jun-2019, the subject's mother underwent first trimester screen and nuchal translucency. No MCM was noted.  On 22-Jul-2019, the subject's mother underwent second trimester screen and maternal serum alpha-fetoprotein (MSAFP/serum markers). No MCM was noted.  On 12-Aug-2019, the subject's mother underwent anatomy ultrasound and no MCM was noted.  On 13-Sep-2019, at 16 weeks of gestation, the subject's mother was administered Flucelvax QIVc (Flu Vaccine Cell Subunit QIV NVD) [influenza vaccine, subunit influenza virus vaccine polyvalent; batch number: 261200, dose, route of administration, anatomical location and expiration date: not reported] (explicitly coded as 'Foetal exposure during pregnancy') for influenza immunisation.   On 10-Oct-2019, the subject's mother was administered 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] for vaccination.  On 06-Jan-2020, the subject's mother had elevated blood pressure at office visit.  The subject's mother underwent labour induction and at gestational age of 40.4 weeks, the mother vaginally delivered live female neonate. The neonate birth weight was 3827 grams and no data were reported for head circumference and length. Appearance, pulse, grimace, activity and respiration (APGAR) scores at one minute was 6 and at five minutes was 9. No data was reported for APGAR score at ten minutes. The neonate experienced labour complication - shoulder dystocia.  At the time of this report, the outcome of shoulder dystocia was not reported.  Per company, the event of shoulder dystocia was considered as serious - medically significant.  The reporter did not provide causality assessment to Flucelvax QIVc.  This case is linked to case 202000562 (corresponding mother case).  Company Comment: The female neonate subject experienced shoulder dystocia after foetal exposure during pregnancy, at gestation age of 16 weeks with the suspect product Flucelvax QIVc. Chronology is plausible. Mother's medical history increased body mass index (27.1) may have contributed to development of the event. Causality is also confounded by mother's therapy with concomitant medication fluticasone propionate. Foetal exposure during pregnancy is assessed as not related per company's conventions. Causality between suspect product and the event shoulder dystocia is assessed as not related due to biological implausibility.; Sender's Comments: The female neonate subject experienced shoulder dystocia after foetal exposure during pregnancy, at gestation age of 16 weeks with the suspect product Flucelvax QIVc. Chronology is plausible. Mother's medical history increased body mass index (27.1) may have contributed to development of the event. Causality is also confounded by mother's therapy with concomitant medication fluticasone propionate. Foetal exposure during pregnancy is assessed as not related per company's conventions. Causality between suspect product and the event shoulder dystocia is assessed as not related due to biological implausibility.