Sex: F
Vaccine: UNK
Symptoms: Apgar score low, Caesarean section, Foetal exposure during pregnancy
Clinical narrative: Fetal exposure during pregnancy; APGAR score 6 at first minute; This is an observational study case, initially reported by other health professional on 06-May-2020, concerning a female, neonate subject whose mother was 23-year-old, female subject of body weight 136 lbs, height 63 inches and body mass index (BMI) 24.1, enrolled in a prospective observational safety study.  The subject's mother medical history included high BMI and morning sickness.  The subject's mother concomitant medications included Prenatal vitamins (unspecified vitamins and minerals) for neonatal care and Bonjesta (doxylamine succinate, pyridoxine hydrochloride) for morning sickness.  The subject's mother obstetrical history noted that the mother had no previous pregnancies. The subject's mother had no history of offspring with major congenital malformation (MCM). The subject's mother had no maternal or paternal history with MCM. It was not provided whether the subject's mother used tobacco, alcohol or illicit drugs during pregnancy.  The subject's mother last menstrual period (LMP) date was 14-Jul-2019. The estimated delivery date (EDD) was reported as 19-Apr-2020 and corrected estimated date of delivery (CEDD) was reported as 17-Apr-2020. The type of pregnancy was singleton. The subject's father was 25 years old.  On 11-Sep-2019, the subject's mother underwent ultrasound and no MCMs were noted.  On 09-Oct-2019, at approximately 12 weeks of gestation (calculated per LMP), the subject's mother was administered Flucelvax QIV (Flu Vaccine Cell Subunit QIV NVD) [influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 mL, batch number reported as 261207, 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 underwent first trimester screen and no MCMs were noted.  On 09-Dec-2019, 2 months after vaccination, the subject's mother experienced ankle fracture and on the same day started treatment with Norco (hydrocodone bitartrate, paracetamol), at dose of one to two tablets, as needed, orally, and ibuprofen, at dose of 800 mg, as needed, orally.  At approximately 39.9 weeks of gestation (as reported), the mother delivered a live female neonate by caesarean method. The neonate's birth weight was 3410 grams, body length was 53.3 cm and head circumference were not reported. The appearance, pulse, grimace, activity, and respiration (APGAR) score at one minute was 6, at five minutes was 7 and no data was provided at ten minutes. No MCMs were identified at the time of birth.   On the same day, the outcome for the event of 'APGAR score low' was resolved.  Per company, the event of 'APGAR score low' was considered as serious due to criterion of medical significance.  The reporter did not provide causality assessment.   This case is linked to the case 201906275, the corresponding mother case.  Company comment: A female neonate subject, whose mother was 23-year-old subject, developed Apgar score low on a birth associated with Flucelvax QIV given an influenza immunisation. Reportedly, at approximately 39.9 weeks of gestation (as reported), the mother delivered a live female neonate by caesarean method. Chronology seems compatible. The subject's mother medical history included high BMI and morning sickness. The subject's mother concomitant medications included Prenatal vitamins (unspecified vitamins and minerals) for neonatal care, Bonjesta (doxylamine succinate, pyridoxine hydrochloride) for morning sickness and Norco (hydrocodone bitartrate, paracetamol) + ibuprofen for ankle fracture.With information presented, causality is assessed as unlikely related to the event. Reported concomitant drugs may confound causality for reported event. Foetal exposure during pregnancy is assessed as unrelated per company conventions. (''unlikely related'' defaults to "related" in the safety database for reporting purposes); Sender's Comments: A female neonate subject, whose mother was 23-year-old subject, developed Apgar score low on a birth associated with Flucelvax QIV given an influenza immunisation. Reportedly, at approximately 39.9 weeks of gestation (as reported), the mother delivered a live female neonate by caesarean method. Chronology seems compatible. The subject's mother medical history included high BMI and morning sickness. The subject's mother concomitant medications included Prenatal vitamins (unspecified vitamins and minerals) for neonatal care, Bonjesta (doxylamine succinate, pyridoxine hydrochloride) for morning sickness and Norco (hydrocodone bitartrate, paracetamol) + ibuprofen for ankle fracture.With information presented, causality is assessed as unlikely related to the event. Reported concomitant drugs may confound causality for reported event. Foetal exposure during pregnancy is assessed as unrelated per company conventions. (''unlikely related'' defaults to "related" in the safety database for reporting purposes)