Age: 24.0
Sex: F
Vaccine: FLUX
Symptoms: Apgar score, Exposure during pregnancy, Pre-eclampsia, Premature delivery, Ultrasound scan normal
Clinical narrative: Delivery at 36.6 weeks of gestation; Pre-eclampsia; Vaccine exposure during pregnancy; This observational study case received on 26-Mar-2021 from other health professional and concerned a 24-year-old, pregnant, female subject (subject ID: 002-0434) of body weight 175 lbs, height 66.3 inches and body mass index (BMI) 28, enrolled in CSLCT-OBS-17-15, 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 increased BMI, anemia and the subject was carrier of beta thalassemia. The subject's concomitant medication included Prenatal plus DHA (unspecified vitamins and minerals plus docosahexaenoic acid) for pregnancy and anemia.  The subject's obstetrical history noted that the subject had one previous pregnancy with elective abortion. The subject had no maternal or paternal history with major congenital malformations (MCMs). The subject did not use tobacco, alcohol or illicit drugs during pregnancy.  The subject's 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 revealed no MCM.  On 29-Sep-2020, at gestational age of 13 weeks (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 reported was P100253284.  On 18-Nov-2020, ultrasound revealed no MCM.  On 10-Mar-2021, five months and nine days after receiving Afluria QIV, the subject developed severe pre-eclampsia.  On 11-Mar-2021, at 36.6 weeks of gestation (as reported), the subject delivered a female neonate vaginally with vacuum extraction. The neonate's birth weight was 1984 g, while head circumference was 31 cm and body length were 45.8 cm. The appearance, pulse, grimace, activity and respiration (APGAR) score was 6 at one minute and was not reported for five and ten minutes. No MCM was identified at birth.  On the same day, the subject recovered from the event of 'pre-eclampsia'.  The outcome of the event of 'premature delivery' was not reported.  The reporter did not provide a causality assessment.  The events of 'premature delivery' and pre-eclampsia were considered to be medically significant by a Physician.  This case is linked with the case 202102141 (the corresponding baby case).  Company comment: A 24-year-old subject was vaccinated with Afluria QIV at gestational age of 13 weeks. Five months and nine days after receiving Afluria QIV, the subject developed severe pre-eclampsia. At 36.6 weeks of gestation, the subject delivered a female neonate vaginally with vacuum extraction. The subject's concurrent conditions included increased BMI, anaemia and the subject was carrier of beta thalassemia. The subject's obstetrical history noted that the subject had one previous pregnancy with elective abortion. Causality is assessed as not related for premature delivery and pre-eclampsia, due to biological/pharmacological implausibility and confounder from medica history (increased BMI). Vaccine exposure during pregnancy assessed as not related per company's conventions.; Sender's Comments: A 24-year-old subject was vaccinated with Afluria QIV at gestational age of 13 weeks. Five months and nine days after receiving Afluria QIV, the subject developed severe pre-eclampsia. At 36.6 weeks of gestation, the subject delivered a female neonate vaginally with vacuum extraction. The subject's concurrent conditions included increased BMI, anaemia and the subject was carrier of beta thalassemia. The subject's obstetrical history noted that the subject had one previous pregnancy with elective abortion. Causality is assessed as not related for premature delivery and pre-eclampsia, due to biological/pharmacological implausibility and confounder from medica history (increased BMI). Vaccine exposure during pregnancy assessed as not related per company's conventions.