Sex: F
Vaccine: FLU4
Symptoms: Apgar score low, Foetal exposure during pregnancy, Low birth weight baby, Premature baby
Clinical narrative: Pre-term birth at 36.6 weeks of gestational age; APGAR score 6 at one minute; Low birth weight of 1984 grams; Foetal exposure during pregnancy; This observational study case was received on 26-Mar-2021 from other health professional and concerned a female neonate, whose mother was 24-year-old, pregnant female subject of body weight: 175 lbs, height: 66.3 inches and body mass index (BMI): 28, a prospective observational safety study..   The maternal concurrent conditions included BMI increased, anaemia and she was carrier of beta thalassemia. The maternal concomitant medication included Prenatal multivitamin + DHA (unspecified vitamins and minerals plus docosahexaenoic acid) used for pregnancy and anaemia.  The maternal obstetrical history included one previous pregnancy with one elective abortion. The neonate's mother had no maternal or paternal history with major congenital malformations (MCMs). The neonate's mother did not use tobacco, alcohol or illicit drugs during pregnancy. The paternal age was 26 years.   The maternal last menstrual period (LMP) date was 27-Jun-2020, the estimated delivery date (EDD) was reported as 03-Apr-2021, while corrected estimated date of delivery (CEDD) was reported as 04-Apr-2021. The type of pregnancy was singleton.   On 31-Aug-2020, ultrasound scan revealed no MCM.  On 29-Sep-2020, at gestational age of 13 weeks (calculated per LMP), the neonate's mother was vaccinated with Afluria QIV (Flu Vaccine Egg Split QIV CSL) (influenza vaccine; dose, route of administration and anatomical location: not reported) (explicitly considered as 'Foetal exposure during pregnancy') for influenza immunisation. The batch number reported was P100253284.  On 18-Nov-2020, ultrasound scan revealed no MCM.  On 10-Mar-2021, the neonate's mother experienced severe pre-eclampsia.   At gestational age of 36.6 weeks (as reported), the mother delivered female neonate, vaginally with vacuum extraction. The birth weight of the neonate was 1984 g, head circumference 31.0 cm and length 45.8 cm. The appearance, pulse, grimace, activity and respiration (APGAR) score at one minute was 6, while scores at five minutes and ten minutes were not reported. No MCM was identified at birth.   The outcome of the events 'low birth weight baby', 'premature birth' and 'apgar score low' was not reported.   The reporter did not provide a causality assessment.  The events of 'low birth weight baby', 'premature birth' and 'apgar score low' were considered to be medically significant by a Physician within Seqirus's Pharmacovigilance and Risk Management Department.  This case is linked with the case 202102140 (the corresponding mother case).  Company comment: A female neonate, whose mother was 24-year-old, pregnant female subject experienced foetal exposure to Afluria QIV. The subject was administered vaccine at approximately 13 weeks of gestation. At gestational age of 36.6 weeks, the mother delivered female neonate, vaginally with vacuum extraction. The birth weight of the neonate was 1984 g. Apgar score at one minute was 6, while scores at five minutes and ten minutes were not reported. No MCM was identified at birth. The neonate's mother experienced severe pre-eclampsia, which may provide alternative aetiology for premature birth and associated events. Causal role of the suspect vaccine is assessed as not related due to mentioned confounders, biological and chronological implausibility. Foetal exposure during pregnancy is assessed as not related to the suspect vaccine.; Sender's Comments: A female neonate, whose mother was 24-year-old, pregnant female subject experienced foetal exposure to Afluria QIV. The subject was administered vaccine at approximately 13 weeks of gestation. At gestational age of 36.6 weeks, the mother delivered female neonate, vaginally with vacuum extraction. The birth weight of the neonate was 1984 g. Apgar score at one minute was 6, while scores at five minutes and ten minutes were not reported. No MCM was identified at birth. The neonate's mother experienced severe pre-eclampsia, which may provide alternative aetiology for premature birth and associated events. Causal role of the suspect vaccine is assessed as not related due to mentioned confounders, biological and chronological implausibility. Foetal exposure during pregnancy is assessed as not related to the suspect vaccine.