Sex: F
Vaccine: FLUX
Symptoms: Apgar score low, Caesarean section, Foetal exposure during pregnancy, Low birth weight baby, Premature baby
Clinical narrative: Foetal exposure during pregnancy; Preterm birth at 25 weeks; APGAR score at one minute was 1,at five minutes was 1 and at ten minutes was 2; Birth weight of 750 g; This is an observational study case, initially reported by other health professional on 25-Feb-2020, concerning a female, neonate subject whose mother was 23-year-old, female subject, of body weight 129 lbs, height 66 inches and body mass index (BMI) 20.8, enrolled in a prospective observational safety study.   The subject's mother's relevant medical history was not reported.  The subject's mother's concomitant medications included Prenatal (unspecified vitamins and minerals) for neonatal care.  The subject's mother's obstetrical history noted that the mother had one previous full term live birth with no birth defects. The subject's mother had no maternal or paternal history with major congenital malformations (MCMs). The subject's mother had no history of offspring with MCMs. The subject's mother did not use tobacco, alcohol or illicit drugs during pregnancy.  The subject's mother's last menstrual period (LMP) date was 04-Aug-2019, the estimated delivery date (EDD) was reported as 10-May-2020 and corrected estimated date of delivery (CEDD) was reported as 09-May-2020. The type of pregnancy was singleton. The subject's father was a 26-year-old.  On 09-Oct-2019, at approximately 9 weeks of gestation, the subject's mother was administered Flucelvax QIV (Flu Vaccine Cell Subunit QIV NVD) [influenza vaccine; batch number: 261207, dose: 0,5 mL, anatomical location, route of administration 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 ultrasound and no MCMs were noted.  At approximately 25 weeks of gestation, the mother gave premature live birth to a female neonate via Caesarean method. Pregnancy complications were noted and included spontaneous rupture of membranes. The neonate birth weight was 750 grams, body length: 12,5 and head circumference was not reported. Appearance, pulse, grimace, activity, and respiration (APGAR) scores were 1 (one minute) and 1 (five minutes) and 2 (ten minutes). No MCMs were identified at the time of birth.   At the time of initial reporting, the outcome for the events of 'APGAR score low', extremely low birth weight baby', premature baby less than 26 weeks' were not reported.  The events of 'APGAR score low', extremely low birth weight baby' and premature baby less than 26 weeks' were considered as serious due to criterion of medical significance, per company.  The reporter did not provide causality assessment.   This case is linked to the case 202001905, the corresponding mother case.  Company comment: A neonate subject was delivered as premature baby, with Apgar score low and low birth weight baby after foetal exposure Flucelvax QIV. Subject's mother was administered vaccine at approximately 9 weeks of gestation and experienced premature delivery 3 months 17 days later. Chronology is unsuggestive. Pregnancy complications included premature rupture of membranes, which may have contributed to development of other events. With information available, causal role of the suspect vaccine cannot be excluded and is assessed as unlikely related (defaults to "related" in the safety database for reporting purposes) to all events. Foetal exposure during pregnancy are assessed as unrelated per company's conventions.; Sender's Comments: A neonate subject was delivered as premature baby, with Apgar score low and low birth weight baby after foetal exposure Flucelvax QIV. Subject's mother was administered vaccine at approximately 9 weeks of gestation and experienced premature delivery 3 months 17 days later. Chronology is unsuggestive. Pregnancy complications included premature rupture of membranes, which may have contributed to development of other events. With information available, causal role of the suspect vaccine cannot be excluded and is assessed as unlikely related (defaults to "related" in the safety database for reporting purposes) to all events. Foetal exposure during pregnancy are assessed as unrelated per company's conventions.