Sex: F
Vaccine: FLUX
Symptoms: Apgar score low, Caesarean section, Foetal exposure during pregnancy
Clinical narrative: Foetal exposure during pregnancy; APGAR score was 2 at one and five minute; This is an observational study case, initially received on 20-Jan-2020, concerning a female neonate subject whose mother was 23-year-old female subject of body weight 217.8 lbs, height 63 inches and body mass index (BMI) 38.6, enrolled in, a prospective observational safety study.   The mother's medical history included BMI high (BMI 38.6) and nausea.   The mother's concomitant medications included Prenatal vitamins (unspecified vitamins and minerals) as vitamin, Bonjesta (doxylamine succinate, pyridoxine hydrochloride) and ondansetron, both used for nausea.  The subject's mother had one previous pregnancies with full term live birth. The subject's mother had no history of offspring with major congenital malformation (MCM) and no relevant maternal and paternal medical history with MCM. The subject's mother did not use tobacco, alcohol or illicit drugs during pregnancy. The father was 40-year-old.  The mother's last menstrual period (LMP) date was on 17-Apr-2019. The type of pregnancy was multiple. The subject's estimated date of delivery (EDD) and corrected estimated date of delivery (CEDD) were both reported as 22-Jan-2020.   On 07-Jun-2019, the subject's mother underwent ultrasound, and no MCM was noted.  On 11-Jul-2019, the subject's mother underwent first trimester screen and early demise of the twin A was reported with no sac visualised. No MCM was noted. On the same day, the subject's mother underwent nuchal translucency and no MCM was noted.  On 12-Aug-2019, the subject's mother underwent anatomy ultrasound, and no MCM was noted.  On 13-Aug-2019, the subject's mother underwent maternal serum alpha fetoprotein screening (MSAFP), and no MCM was noted.  On 24-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: 261215, dose: 0.5 mL, route of administration, anatomical location and expiration date: not reported] (explicitly coded as 'Foetal exposure during pregnancy') for influenza immunisation.   On 15-Jan-2020, at 40 weeks of gestation, the subject's mother delivered live birth, female neonate via caesarean method of delivery. The neonate's birth weight was 3461 grams, body length and head circumference were not reported. The appearance, pulse, grimace, activity and respiration (APGAR) score was at one minute: 2, at five minutes: 2 and at ten minutes: not reported. There was no MCM identified at birth.  At the time of the initial report, the outcome of the event APGAR score low' was not reported.  The event of APGAR score low' was assessed as serious due to medically significance, per company.   The causality assessment was not provided.  The case is linked to case 201907072 (the corresponding mother case).  The neonate subject had APGAR score low after foetal exposure during pregnancy at approximately 27 weeks of gestation with the suspect product, Flucelvax QIV. Chronology is plausible. The mother's medical history of obesity (body mass index 38.6) and mother's concomitant medications Bonjesta (doxylamine succinate, pyridoxine hydrochloride) and ondansetron may have contributed to development of the event. Pregnant state may provide alternative aetiology for the event. Foetal exposure during pregnancy is assessed as not related per company's conventions. Considering all the above mentioned, causality between suspect product and the event APGAR score low is assessed as unlikely related (defaults to related for reporting purposes).; Sender's Comments: The neonate subject had APGAR score low after foetal exposure during pregnancy at approximately 27 weeks of gestation with the suspect product, Flucelvax QIV. Chronology is plausible. The mother's medical history of obesity (body mass index 38.6) and mother's concomitant medications Bonjesta (doxylamine succinate, pyridoxine hydrochloride) and ondansetron may have contributed to development of the event. Pregnant state may provide alternative aetiology for the event. Foetal exposure during pregnancy is assessed as not related per company's conventions. Considering all the above mentioned, causality between suspect product and the event APGAR score low is assessed as unlikely related (defaults to related for reporting purposes).