Sex: M
Vaccine: FLUX
Symptoms: Apgar score low, Caesarean section, Foetal exposure during pregnancy, Premature baby
Clinical narrative: Fetal exposure during pregnancy; Preterm birth; APGAR score at one minute was 3; This is an observational study case, initially received from other health professional on 06-Apr-2020, concerning a male neonate subject, whose mother was 24-year-old, pregnant, female subject of body weight: 169 lbs, height: 64 inches and body mass index (BMI): 29 enrolled in a prospective observational safety study.   The mother's medical history included body mass index high and nausea.  The mother's concomitant medications included Prenatal (unspecified vitamins and minerals) for pregnancy and ondansetron for nausea.  The mother's obstetrical history included no previous pregnancies. The subject's mother had no history of offspring with major congenital malformation (MCM) and no relevant maternal and paternal medical history. The subject's mother did not use tobacco, alcohol or illicit drugs during pregnancy.  The mother's last menstrual period (LMP) date was 15-May-2019. The mother's estimated date of delivery (EDD) was reported as 12-Mar-2020 and corrected estimated date of delivery (CEDD) was reported as 13-Mar-2020. The type of pregnancy was singleton. The subject's father age was 26.  On 08-Aug-2019, the subject's mother underwent ultrasound and no MCM was noted.  On 30-Aug-2019, the subject's mother underwent first trimester screen and no MCM was noted.  On 17-Oct-2019, at gestational age of approximately 22 weeks (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: 261226, route of administration, anatomical location and expiry date: not reported] (explicitly coded as 'Foetal exposure during pregnancy') for influenza immunization.   At gestational age of 36.1 weeks (as reported), the subject's mother delivered a live male neonate via caesarean method. The subject's birth weight was 2523 grams, head circumference 31 cm and body length 47 cm. The appearance, pulse, grimace, activity and respiration (APGAR) scores were 3 at one minute and 7 at five minutes. APGAR score was not reported for 10 minutes. There was no MCM identified at birth.  On the same day, the outcome for the event of 'APGAR score low' was resolved.  At the time of initial reporting, the outcome of the event 'premature baby' was not reported.  Per company, the events of 'premature baby' and 'APGAR score low' were considered serious due to the criterion of medical significance.  This reporter did not provide the causality assessment to Flucelvax QIV.  This case is linked to case 202002763 (the corresponding mother case).  Company comment: A male neonate subject, whose mother was 24-year-old pregnant female subject, developed premature baby and Apgar score low after vaccination with the suspect product Flucelvax QIV for influenza immunisation. Reportedly, at gestational age of 36.1 weeks (as reported), the subject's mother delivered a live male neonate via caesarean method. Chronology seems compatible. The mother's medical history included body mass index high and nausea. The mother's concomitant medications included Prenatal (unspecified vitamins and minerals) for pregnancy and ondansetron for nausea. With information presented, causality is assessed as unrelated for premature baby. Obesity or BMI high is known to increase the risk of "medically indicated" premature birth  that is, premature birth that is deliberately initiated by doctors, with a caesarean section or by inducing labour. Premature delivery could explain low Apgar score making it also unrelated to the product. Foetal exposure during pregnancy is assessed as unrelated per company conventions.; Sender's Comments: A male neonate subject, whose mother was 24-year-old pregnant female subject, developed premature baby and Apgar score low after vaccination with the suspect product Flucelvax QIV for influenza immunisation. Reportedly, at gestational age of 36.1 weeks (as reported), the subject's mother delivered a live male neonate via caesarean method. Chronology seems compatible. The mother's medical history included body mass index high and nausea. The mother's concomitant medications included Prenatal (unspecified vitamins and minerals) for pregnancy and ondansetron for nausea. With information presented, causality is assessed as unrelated for premature baby. Obesity or BMI high is known to increase the risk of "medically indicated" premature birth  that is, premature birth that is deliberately initiated by doctors, with a caesarean section or by inducing labour. Premature delivery could explain low Apgar score making it also unrelated to the product. Foetal exposure during pregnancy is assessed as unrelated per company conventions.