Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Alpha 1 foetoprotein, Exposure during pregnancy, Premature delivery, Prenatal screening test, Ultrasound scan
Clinical narrative: Delivery at 36 weeks of gestation; Vaccine exposure during pregnancy; This observational study case was received from other health professional on 24-Feb-2021 and concerned 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 on pregnancy outcome in women immunized with Afluria QIV, a seasonal quadrivalent vaccine, during pregnancy.  The subject's concurrent conditions included beta thalassaemia (thal) minor and the subject was Rh negative. The subject's concomitant medication included Multivitamin (unspecified vitamins) for pregnancy.  The subject's obstetrical history included one previous pregnancy with full term live birth. The subject had no offspring with major congenital malformations (MCMs). The subject had no maternal or paternal history with MCMs. The subject did not use tobacco, alcohol or illicit drugs during pregnancy.  The subject'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.  On 17-Dec-2019, ultrasound revealed no MCM.  On 14-Jan-2020, at approximately 12 weeks of gestation (calculated per LMP), the subject 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 'vaccine 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 subject 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 delivery' was not reported.  The reporter did not provide a causality assessment.  The event of 'premature delivery' was considered to be medically significant by a Physician within Seqirus's Pharmacovigilance and Risk Management Department.  This case is linked to 202101501 (the corresponding baby case).  Company comment: A 33-year-old pregnant subject was administered Afluria QIV at approximately 12 weeks of gestation. The subject experienced premature delivery 5 months and 12 days after vaccination. Chronology is implausible. The subject's concurrent conditions included beta thalassaemia minor and the subject was Rh negative. Causal role of the suspect vaccine is assessed as not related. Vaccine exposure during pregnancy is assessed as unrelated per company's conventions.; Sender's Comments: A 33-year-old pregnant subject was administered Afluria QIV at approximately 12 weeks of gestation. The subject experienced premature delivery 5 months and 12 days after vaccination. Chronology is implausible. The subject's concurrent conditions included beta thalassaemia minor and the subject was Rh negative. Causal role of the suspect vaccine is assessed as not related. Vaccine exposure during pregnancy is assessed as unrelated per company's conventions.