Sex: F
Vaccine: UNK
Symptoms: Apgar score abnormal, Caesarean section, Foetal exposure during pregnancy, Low birth weight baby, Premature baby
Clinical narrative: Foetal exposure during pregnancy; Birth at 28.3 weeks; Baby birth weigh was 97 grams; APGAR score at one minute was one and at five minutes was four; This is an observational study case, initially received from other health professional on 24-Mar-2020, concerning a female neonate whose mother was 28-year-old, female pregnant subject, of body weight: 132 lbs, height: 67 inches and body mass index (BMI): 20.7, enrolled in a prospective observational safety study.  The subject's mother's medical history was not provided.   The subject's mother's concomitant medications included Prenatal vitamins (unspecified vitamins) for pregnancy.  The subject's mother had four previous pregnancies with one full term live birth, one elective abortion and two spontaneous abortions. The subject's mother had no history of offspring with major congenital malformation (MCM). The subject's mother had no relevant maternal and paternal medical history with MCM. The subject's mother did not use tobacco, illicit drug or alcohol during pregnancy. The father was 28-year-old.  The subject's mother's last menstrual period (LMP) date was reported as 15-Apr-2019. The subject's mother's estimated delivery date (EDD) and corrected estimated date of delivery (CEDD) were reported as 04-Feb-2020. The type of pregnancy was singleton.  On 18-Jun-2019, the subject's mother underwent cystic fibrosis mutation analysis and spinal muscular atrophy test and no MCM was noted.  On 21-Aug-2019, the subject's mother underwent panorama test and no MCM was noted.  On 19-Sep-2019, the subject's mother underwent ultrasound and no MCM was noted.  On 17-Oct-2019, at approximately 26 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 262218, anatomical location, route of administration and expiration date: not reported] (explicitly coded as Foetal exposure during pregnancy') for an influenza immunisation.   At gestational age of 28.3 weeks (as reported), the subject's mother delivered live birth, female neonate via caesarean method of delivery. The neonate's birth weight was reported as 97 grams, her head circumference and length were not provided and APGAR (appearance, pulse, grimace, activity and respiration) scores were 1 at one minute, 4 at five minutes and 7 at ten minutes. There were no major MCMs identified at birth. On the same day, the subject's mother underwent ultrasound and no MCM was noted. The outcome of 'APGAR score low' was resolved.  On the same day, the subject's mother developed syphilis and was treated with penicillin, at a dose of one gram, intramuscularly, administered once. On the same day, the subject's mother recovered from the event syphilis.  At the time of this report, the outcome of the events premature baby' and 'low birth weight baby' was not reported.  The events of premature baby', 'low birth weight baby' and 'APGAR score low' were assessed as serious, due to criterion of medical significance.   The reporter did not provide causality assessment.  The case is linked to the case 202002611 (mother case).  Company Comment: The male neonate subject was delivered as premature baby, with low birth weight and apgar score low, 28 days after foetal exposure to Flucelvax QIVc. Vaccine was administered at gestation age of 26 weeks. Chronology is plausible. Foetal exposure during pregnancy is assessed as not related per company's conventions. Causality between suspect product and the events low birth weight baby, premature baby and apgar score low is assessed as unlikely related (defaults to related for reporting purposes).; Sender's Comments: The male neonate subject was delivered as premature baby, with low birth weight and apgar score low, 28 days after foetal exposure to Flucelvax QIVc. Vaccine was administered at gestation age of 26 weeks. Chronology is plausible. Foetal exposure during pregnancy is assessed as not related per company's conventions. Causality between suspect product and the events low birth weight baby, premature baby and apgar score low is assessed as unlikely related (defaults to related for reporting purposes).