Sex: F
Vaccine: FLUX
Symptoms: Apgar score normal, Foetal exposure during pregnancy, Low birth weight baby, Premature baby
Clinical narrative: Foetal exposure during pregnancy; Preterm birth at 32.6 weeks of gestation; Low birth weight of 1984 g; This observational study case, initially received on 07-Dec-2020 from other health professional and concerned a female neonate subject, whose mother was 31-year-old, pregnant subject of body weight 146 lbs, height 63 inches and body mass index (BMI): 25.9,  enrolled in, a prospective observational safety study on pregnancy outcomes in women immunized with Afluria QIV, a seasonal quadrivalent vaccine, during pregnancy.   The neonate's mother's concurrent conditions included increased BMI. The mother's concomitant medications included Niferex (polysaccharide-iron complex) and Prenatal vitamins (minerals not specified (nos), vitamins nos) both used for pregnancy.  The mother's obstetrical history included no previous pregnancies. The neonate's mother had no history of offspring with major congenital malformation (MCM). Also, the neonate's mother had no maternal or paternal history with MCM. The neonate's mother did not use tobacco, alcohol or illicit drugs during pregnancy.  The mother's last menstrual period (LMP) date was reported as 07-Apr-2020. The mother's estimated delivery date (EDD) was not reported and corrected estimated date of delivery (CEDD) was 12-Jan-2021 . The type of pregnancy was singleton. The neonate's father was 31-year-old.  On 08-Jun-2020, the ultrasound revealed no MCM.  On 30-Jun-2020, first trimester screen revealed increased risk for Down's syndrome and no MCM. Also, ultrasound revealed no MCM.  On 12-Aug-2020, ultrasound revealed no MCM.  On 27-Oct-2020, at approximately 29 weeks of gestation (calculated per LMP), the neonate's mother was vaccinated with Afluria QIV (Flu Vaccine Egg Split QIV CSL) (influenza vaccine, dose, route of administration, anatomical location: not reported) (explicitly coded as 'Foetal exposure during pregnancy') for an influenza immunisation. The batch number reported was P100265371.  On 11-Nov-2020, 15 days after receiving Afluria QIV, the neonate's mother developed premature rupture of membranes.  At gestational age of 32.6 weeks (as reported), the mother delivered a preterm live birth, female neonate vaginally. The neonate birth weight was 1984 grams, head circumference 30 cm and length 44.5 cm. Appearance, pulse, grimace, activity, and respiration (APGAR) scores were 8 (one minute) and 9 (five minutes). No date for APGAR score at 10 minutes was provided. No MCM was identified at birth.  On the same day, the mother recovered from prolonged premature rupture of membranes.  The outcome for the events 'premature baby 26 to 32 weeks' and 'low birth weight baby' was not reported.  The reporter did not provide causality assessment.  The events 'premature baby 26 to 32 weeks' and 'low birth weight baby' were considered to be medically significant by a Physician within Seqirus's Pharmacovigilance and Risk Management Department.  This case is linked to the case 202007590, the corresponding mother case.  Company comment: A female neonate subject, whose mother was 31-year-old pregnant subject, experienced premature baby and low birth weight baby 15 days after administration of Afluria QIV to the subject's mother. Causality is assessed as unrelated to vaccine due to unsuggestive chronology and biological implausibility and more likely related to the increased BMI of the subject's mother. Increased BMI most likely resulted in premature rupture of membranes and premature delivery/ low birth weight baby. Foetal exposure during pregnancy is assessed as unrelated per company conventions.; Sender's Comments: A female neonate subject, whose mother was 31-year-old pregnant subject, experienced premature baby and low birth weight baby 15 days after administration of Afluria QIV to the subject's mother. Causality is assessed as unrelated to vaccine due to unsuggestive chronology and biological implausibility and more likely related to the increased BMI of the subject's mother. Increased BMI most likely resulted in premature rupture of membranes and premature delivery/ low birth weight baby. Foetal exposure during pregnancy is assessed as unrelated per company conventions.