Sex: F
Vaccine: FLUX
Symptoms: Apgar score normal, Foetal exposure during pregnancy, Low birth weight baby, Premature baby
Clinical narrative: Born at 34 weeks of gestation; Birth weight 2450 g; Foetal exposure during pregnancy; This is an observational study case, initially received from other health professional on 06-May-2020, concerning a female, neonate subject whose mother was a 27-year-old, pregnant female, of body weight: 161.2 lbs, height: 67 inches and body mass index (BMI): 25.2, enrolled in a prospective observational safety study.   The subject's mother's medical history included anxiety and high BMI.  The subject's mother's concomitant medications included escitalopram for anxiety.  The subject's mother's obstetrical history noted that the subject's mother had two previous full-term live births. The subject's mother had no history of offspring with major congenital malformation (MCM). The subject's mother had no relevant maternal or paternal medical history. The subject's mother did not use tobacco, illicit drugs or alcohol during pregnancy. The subject's father was 28-year-old.  The subject's mother's last menstrual period (LMP) date was reported as 26-Aug-2019. The subject's mother's estimated delivery date (EDD) was reported as 31-May-2020 and corrected estimated date of delivery (CEDD) was reported as 21-May-2020. The type of pregnancy was singleton.   On 28-Oct-2019, at approximately 9 weeks of gestation (calculated per LMP), the subject's mother was administered Flucelvax QIVc (Flu Vaccine Cell Subunit QIV NVD) [influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, batch number: 261207, anatomical location, route of administration and expiration date: not reported] (explicitly coded as Foetal exposure during pregnancy') for influenza immunisation.   On the same day, the subject's mother underwent ultrasound and no MCM was noted.  On 21-Nov-2019, the subject's mother underwent prenatal labs and no MCM was noted.  On 16-Dec-2019, the subject's mother underwent ultrasound and no MCM was noted.   On an unspecified date, the subject's mother experienced preterm rupture of membranes.  At gestational age of 34 weeks (as reported), the subject's mother vaginally delivered preterm live birth female neonate. The subject's birth weight was 2450 g, while head circumference and length were not provided. The appearance, pulse, grimace, activity and respiration (APGAR) scores were 8 (one minute), 9 (five minutes), and APGAR score for ten minutes was not reported. There were no major MCMs identified at birth.  At the time of this report, the outcome of the events Premature baby 33 to 36 weeks' and 'Low birth weight baby' was not reported.  The events of Premature baby 33 to 36 weeks' and 'Low birth weight baby' were assessed as serious due to criteria of medical significance, per company.   The reporter did not provide causality assessment.  This case is linked to the case 202003312, the corresponding mother case.  Company comment: A female neonate subject, whose mother was a 27-year-old pregnant female, developed premature baby and low birth weight baby after the subject's mother was administered Flucelvax QIVc for infuenza. Reportedly, at gestational age of 34 weeks (as reported), the subject's mother vaginally delivered preterm live birth female neonate with low weight. Chronology seems compatible. There were no major MCMs identified at birth. The subject's mother's medical history included anxiety and high BMI. The subject's mother's concomitant medications included escitalopram for anxiety. The subject's mother's obstetrical history noted that the subject's mother had two previous full-term live births. The subject's mother had no history of offspring with major congenital malformation (MCM). With information presented, causality is assessed as not related fo both events considering reported medical history of the mother. Foetal exposure during pregnancy is assessed as unrelated per company conventions.; Sender's Comments: A female neonate subject, whose mother was a 27-year-old pregnant female, developed premature baby and low birth weight baby after the subject's mother was administered Flucelvax QIVc for infuenza. Reportedly, at gestational age of 34 weeks (as reported), the subject's mother vaginally delivered preterm live birth female neonate with low weight. Chronology seems compatible. There were no major MCMs identified at birth. The subject's mother's medical history included anxiety and high BMI. The subject's mother's concomitant medications included escitalopram for anxiety. The subject's mother's obstetrical history noted that the subject's mother had two previous full-term live births. The subject's mother had no history of offspring with major congenital malformation (MCM). With information presented, causality is assessed as not related fo both events considering reported medical history of the mother. Foetal exposure during pregnancy is assessed as unrelated per company conventions.