Age: 34.0
Sex: F
Vaccine: FLUX
Symptoms: Caesarean section, Exposure during pregnancy, Hypertension, Pre-eclampsia, Premature delivery
Clinical narrative: Delivery at 36.1 weeks of gestation; Hypertension; Vaccine exposure during pregnancy; Pre-eclampsia (third trimester); This is an observational study case, initially received from other health professional on 20-Jan-2020, concerning a 34-year-old, female pregnant subject of body weight: 183 lbs, height: 62 inches and body mass index (BMI): 33.5 enrolled in a prospective observational safety study.   The subject's past drugs included benzonatate and azithromycin Z-pack, both for upper respiratory infection.  The subject's historical conditions included history of severe pre-eclampsia in both previous pregnancies, HELLP syndrome in first pregnancy and upper respiratory infection.   The subject's current conditions included obesity, factor V deficiency, high risk pregnancy and mild hyperemesis gravidarum.  The subject's concomitant medications included betamethasone for high risk pregnancy, Phenergan (promethazine) and ondansetron, both for hyperemesis gravidarum, Lovenox (enoxaparin sodium) and Aspirin low (acetylsalicylic acid), both for factor V deficiency, Prenatal vitamins (minerals nos; vitamins nos) as vitamin and Tdap (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid) as vaccine.  The subject's obstetrical history noted that subject had two previous pregnancies with two preterm live births. The subject had history of offspring with major congenital malformation (MCM). The subject's first child had cerebral palsy and optical nerve did not form behind one eye. 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 22-Apr-2019. The subject's estimated delivery date (EDD) and corrected estimated date of delivery (CEDD) were 27-Jan-2020. The type of pregnancy was singleton.   On 11-Jun-2019, the subject initial ultrasound test and no MCM was noted.  On 01-Jul-2019, the subject underwent materniT 21 test and no MCM was noted.  On 12-Aug-2019, the subject underwent maternal serum alpha fetoprotein (MSAFP) / serum markers and no MCM was noted.  On 19-Aug-2019, the subject underwent anatomy ultrasound and the results were unknown.  On 16-Sep-2019, the subject underwent follow up ultrasound and no MCM was noted.  On 14-Oct-2019, at gestational age of 25 weeks, the subject was administered Flucelvax QIVc (Flu Vaccine Cell Subunit QIV NVD) [influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, batch number: 259809, anatomical location, route of administration and expiration date: not reported] (explicitly coded as Vaccine exposure during pregnancy') for influenza immunisation.   On 18-Nov-2019, 1 month 4 days after vaccination, the subject developed hypertension, and was treated with labetalol, 100 mg, twice a day (bid), orally from the same day and ongoing.  On an unspecified date in 2019, during third trimester of pregnancy, an unknown amount of time after vaccination the subject developed pre-eclampsia.  At gestational age of 36.1 weeks, the subject delivered live birth, female neonate by caesarean delivery. The neonate's birth weight was 2041 g, his head circumference and length were not provided. The appearance, pulse, grimace, activity, and respiration (APGAR) scores were 8 (one minute) and 8 (five minutes).   At the time of this report, the outcome of the events premature delivery and pre-eclampsia was not reported, while the outcome of the event hypertension was not resolved.  The events of pre-eclampsia and premature delivery were assessed as serious due to criterion of medical significance.  The reporter did not provide causality assessment to Flucelvax QIV.  The case is linked to case 202000602, the corresponding child case.  Company comment: A pregnant subject experienced pre-eclampsia, hypertension and premature delivery after Flucelvax QIV was administered. The vaccine was administered at gestation age of 25 weeks. Causality was highly confounded by subject's current condition of obesity, factor V deficiency, high risk pregnancy and historical conditions of severe pre-eclampsia in both previous pregnancies, HELLP syndrome in first pregnancy. Reportedly, the subject had two previous pregnancies of preterm live birth with one birth defect in first pregnancy including cerebral palsy and optic nerve did not form behind one eye. Due to multiple confounders, 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 pregnant subject experienced pre-eclampsia, hypertension and premature delivery after Flucelvax QIV was administered. The vaccine was administered at gestation age of 25 weeks. Causality was highly confounded by subject's current condition of obesity, factor V deficiency, high risk pregnancy and historical conditions of severe pre-eclampsia in both previous pregnancies, HELLP syndrome in first pregnancy. Reportedly, the subject had two previous pregnancies of preterm live birth with one birth defect in first pregnancy including cerebral palsy and optic nerve did not form behind one eye. Due to multiple confounders, causal role of the suspect vaccine is assessed as not related. Vaccine exposure during pregnancy is assessed as unrelated per company's conventions.