Age: 32.0
Sex: F
Vaccine: UNK
Symptoms: Prenatal screening test, Ultrasound antenatal screen normal
Clinical narrative: Pre-eclampsia; Gestational Diabetes Mellitus Diet controlled Type 2 (GDMA2); Vaccine exposure during pregnancy; This is an observational study case, initially received from other health professional on 18-Dec-2019, concerning a 32-year-old, female pregnant subject of body weight: 186 lbs, height: 62 inches and body mass index (BMI): 34 enrolled in a prospective observational safety study.   The subject's current medical conditions included anemia and body mass index high.  The subject's concomitant medications included ferrous sulfate for anemia and docusate sodium for an unknown indication.  The subject's obstetrical history noted that subject had no previous pregnancies. The subject had no history of offspring with major congenital malformation (MCM). The subject had no relevant maternal and paternal medical history. The subject did not use tobacco, illicit drug or alcohol during pregnancy.  The subject's last menstrual period (LMP) date was 18-Jun-2019. The subject's estimated delivery date (EDD) was 24-Mar-2020 and corrected estimated date of delivery (CEDD) was not provided. The type of pregnancy was singleton.   On 21-Oct-2019, at gestational age of 17 weeks (calculated per LMP), the subject was administered with Afluria QIV (Flu Vaccine Egg Split QIV CSL) [influenza vaccine; batch number: P100112488, dose, route of administration, anatomical location and expiration date: not reported] (explicitly coded as Vaccine exposure during pregnancy') for influenza immunisation.   On the same day, the subject underwent prenatal panel test and no MCM was noted.  On 06-Nov-2019, the subject underwent targeted ultrasound and no MCM was noted.  On 27-Dec-2019, 2 months 6 days after vaccination, the subject developed gestational diabetes mellitus diet controlled type 2 (GDMA2).   On 25-Feb-2020, 4 months 4 days after vaccination, it was noted that the foetus was large for gestational age.  On 03-Mar-2020, 4 months 11 days after vaccination, the subject developed pre-eclampsia.  At 38 weeks of gestation (as reported), the vaginally delivered a live birth male neonate. The characteristics of the neonate included: birth weight 3700 grams, head circumference and length were not reported. The appearance, pulse, grimace, activity, and respiration (APGAR) scores were 5 (one minute) and 8 (five minutes). There was no APGAR score data for 10 minutes reported for both neonates. No MCMs were identified at birth.  On the same day, the subject recovered from gestational diabetes mellitus diet-controlled type 2 (GDMA2) and pre-eclampsia. Also, the foetus recovered from large for gestational age.  The events of pre-eclampsia and 'gestational diabetes mellitus' were considered serious due to criterion of medical significance, per company.  This case is linked to the case 202003399, the corresponding child case.  The reporter did provide not provide causality assessment to Afluria QIV.  Follow up information from other health professional received on 11-May-2020: Events of pre-eclampsia and 'gestational diabetes mellitus' were added, seriousness of the case was changes from non-serious to serious and listedness of the case was changed from listed to unlisted. Pregnancy outcome was provided. 'Large for gestational age' was reported as pregnancy complication and the baby case was opened. Stop date was added for event vaccine exposure during pregnancy and outcome was changed from 'not reported' to 'recovered/resolved'. Narrative amended accordingly.  Company comment: A 32-year-old female pregnant subject developed pre-eclampsia and gestationl diabetes after vaccination with the suspect product Afluria QIV for influenza immunisation. Reportedly, 2 months 6 days after vaccination, the subject developed gestational diabetes mellitus - diet controlled type 2 (GDMA2). Chronology seems plausible. The subject's current medical conditions included anemia and body mass index high. The subject's concomitant medications included ferrous sulfate for anemia and docusate sodium for an unknown indication. With information presented, causality is assessed as unrelated for both events. Exposure during pregnancy is assessed as unrelated per company conventions.; Sender's Comments: A 32-year-old female pregnant subject developed pre-eclampsia and gestationl diabetes after vaccination with the suspect product Afluria QIV for influenza immunisation. Reportedly, 2 months 6 days after vaccination, the subject developed gestational diabetes mellitus - diet controlled type 2 (GDMA2). Chronology seems plausible. The subject's current medical conditions included anemia and body mass index high. The subject's concomitant medications included ferrous sulfate for anemia and docusate sodium for an unknown indication. With information presented, causality is assessed as unrelated for both events. Exposure during pregnancy is assessed as unrelated per company conventions.