Sex: F
Vaccine: FLU4
Symptoms: Foetal exposure during pregnancy, Premature baby
Clinical narrative: Foetal exposure during pregnancy; Preterm birth at 36.4 weeks of gestation; This is an observational study case received on 23-Apr-2021 from other health professional and concerned a female neonate whose mother was 29-year-old, pregnant female subject of body weight: 181.5 lbs, height: 68.3 inches and body mass index (BMI): 27.4, a prospective observational safety study on pregnancy outcomes in women immunized with Afluria QIV, a seasonal quadrivalent vaccine, during pregnancy.   The maternal concurrent condition included BMI increased, mushroom allergy, anxiety and discoid lupus erythematosus. The maternal concomitant medication included Prenatal DHA vitamin (unspecified vitamins and docosahexaenoic acid) for pregnancy, escitalopram for anxiety and hydroxychloroquine for discoid lupus erythematous.   The maternal obstetrical history noted that subject did not have previous pregnancies. The neonate's mother had no history of offspring with major congenital malformation (MCM). The mother had no maternal or paternal history with MCM. The mother did not use tobacco, alcohol or illicit drugs during pregnancy.   The maternal last menstrual period (LMP) date was 17-Jul-2020, estimated delivery date (EDD) was reported as 23-Apr-2021 and corrected estimated date of delivery (CEDD) was reported as 14-Apr-2021. The type of pregnancy was singleton. The paternal age was 34-year-old.   On 10-Sep-2020, at gestational age of seven 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 coded as 'Foetal exposure during pregnancy') for influenza immunisation. The batch number reported was P100230203.   On the same day, ultrasound scan revealed no MCM.   On 01-Oct-2020, Regulatory Authority panel with fragile X (20 conditions) and counsyl chromosomes 13, 18, 21 plus sex chromosome analysis revealed no MCM.   On 05-Nov-2020, maternal serum alpha-fetoprotein (MSFP)/ serum markers revealed   On 03-Dec-2020, ultrasound scan revealed no MCM.   On 29-Mar-2021, at gestational age of 36.4 weeks (as reported), the mother delivered live preterm female neonate via caesarean method of delivery. The neonate's birth weight was 2863 grams, head circumference: 25 cm and body length: 48 cm. The appearance, pulse, grimace, activity, and respiration (APGAR) scores were 7 (one minute) and 9 (five minutes).  The APGAR score at ten minutes was not provided. No MCM and no pregnancy complications were identified at delivery.   The outcome of 'premature baby' was not reported.   The reporter did not provide a causality assessment to Afluria QIV.  The event of 'premature baby' was considered to be medically significant by a Physician within Seqirus' Regulatory Authority.  This case is linked to a case 202102295 (the corresponding mother case).  Company comment: A female neonate, exposed in utero to Afluria QIV at seven weeks of gestation, was born as a premature baby at of 36.4 weeks of gestation. Chronology is unsuggestive. The neonate's mother's concurrent condition included BMI increased which may have contributed to development of premature baby. Causal relationship is assessed as not related. Foetal exposure during pregnancy is assessed as not related per company conventions.; Sender's Comments: A female neonate, exposed in utero to Afluria QIV at seven weeks of gestation, was born as a premature baby at of 36.4 weeks of gestation. Chronology is unsuggestive. The neonate's mother's concurrent condition included BMI increased which may have contributed to development of premature baby. Causal relationship is assessed as not related. Foetal exposure during pregnancy is assessed as not related per company conventions.