Sex: F
Vaccine: FLU4
Symptoms: Foetal exposure during pregnancy, Premature baby, Premature delivery
Clinical narrative: Vaccine fetal exposure during pregnancy; Preterm birth at 36 weeks of gestation; This observational study case was received from other health professional  on 24-Feb-2021 and concerned a female neonate, whose mother was a 33-year-old, pregnant, female subject of body weight 138 lbs, height 65 inches and body mass index (BMI) 23, enrolled in, a prospective observational safety study.  The maternal concurrent conditions included beta thalassaemia (thal) minor and the neonate's mother was Rh negative. The maternal concomitant medication included Multivitamin (unspecified vitamins) for pregnancy.  The maternal obstetrical history included one previous pregnancy with full them live birth. The neonate's mother had no offspring with major congenital malformations (MCMs). The neonate's mother had no maternal or paternal history with MCMs. The neonate's mother did not use tobacco, alcohol or illicit drugs during pregnancy.  The neonate's mother's last menstrual period (LMP) date was 17-Oct-2019, the estimated delivery date (EDD) was 23-Jul-2020 and corrected estimated date of delivery (CEDD) was not reported. The type of pregnancy was singleton. The neonate's father's age was not reported.  On 17-Dec-2019, ultrasound revealed no MCM.  On 14-Jan-2020, at approximately 12 weeks of gestation (calculated per LMP), the neonate's mother was vaccinated with Afluria QIV (Flu Vaccine Egg Split QIV CSL) (influenza vaccine; dose, anatomical location and  route of administration: not reported] (explicitly coded as 'fetal exposure during pregnancy') for influenza immunisation. The batch number was P100112488.  On the same day, non-invasive prenatal testing revealed no MCM.  On 14-Feb-2020, maternal serum alpha-fetoprotein (MSAFP)/ serum markers revealed no MCM.  At 36 weeks of gestation (as reported), the neonate's mother vaginally delivered a female neonate. The neonate's birth weight was 2920 g, head circumference and length were not reported. APGAR (appearance, pulse, grimace, activity and respiration) scores at one minute, at five minutes and at ten minutes were not reported. No MCM was identified at birth.  The outcome of the event of 'premature baby 33 to 36 weeks' was not reported.  The reporter did not provide a causality assessment.  The event of 'premature baby 33 to 36 weeks' was considered to be medically significant by a Physician within Seqirus's Pharmacovigilance and Risk Management Department.  This case is linked to 202101500 (the corresponding mother case).  Company comment: A female neonate was exposed to the suspect product, Afluria QIV. The neonate's mother was vaccinated with Afluria QIV at approximately 12 weeks of gestation. The neonate experienced premature birth at 36 weeks of gestation (5 months and 12 days after vaccination). The maternal concurrent conditions included beta thalassaemia minor and the neonate's mother was Rh negative. Causal role of the suspect vaccine is assessed as not related. Foetal exposure during pregnancy is assessed as not related per company's conventions.; Sender's Comments: A female neonate was exposed to the suspect product, Afluria QIV. The neonate's mother was vaccinated with Afluria QIV at approximately 12 weeks of gestation. The neonate experienced premature birth at 36 weeks of gestation (5 months and 12 days after vaccination). The maternal concurrent conditions included beta thalassaemia minor and the neonate's mother was Rh negative. Causal role of the suspect vaccine is assessed as not related. Foetal exposure during pregnancy is assessed as not related per company's conventions.