Age: 29.0
Sex: F
Vaccine: FLUC4
Symptoms: Ultrasound antenatal screen normal
Clinical narrative: Elevated liver enzymes; Abnormal glucose tolerance test; Cholestasis; Anemia; Vaccine exposure during pregnancy; Prenatal test abnormality-positive for open spina bifida; This is spontaneous case, initially received from other health professional on 09-Dec-2019, concerning a 29-year-old pregnant female patient of body weight 220 pounds, height 66 inches and body mass index (BMI) 35.5. The paternal age was 30 years.   The patient's medical history included: anxiety, obesity, nausea and gastroesophageal reflux disease.  The patient's concomitant medication included: Zantac (ranitidine hydrochloride) for gastroesophageal reflux disease, Multivitamin (vitamins nos) for vitamin as reported and promethazine for nausea.   The patient's obstetrical history included one previous pregnancy with one full term live birth. The patient had no history of offspring with major congenital malformation (MCM) and no relevant maternal and paternal medical history. The mother did not use tobacco, alcohol or illicit drugs during pregnancy.   The patient's last menstrual period (LMP) date was 21-Apr-2019. The type of pregnancy was multiple (mono/di). The patient's estimated delivery date (EDD) was reported as 24-Jan-2020 and corrected estimated date of delivery (CEDD) was reported as 24-Jan-2020.   On 11-Jun-2019, the patient underwent ultrasound scan and MCM was noted.  On 22-Jul-2019, the patient underwent first trimester screen and nuchal translucency screen and no MCM was noted.  On 12-Aug-2019, the patient had MSAFP/serum markers analysis and no MCM was noted. On the same day the patient underwent second trimester screen and results were positive for open spina bifida.   On 14-Aug-2019 the patient underwent ultrasound scan and MCM was noted.  On 11-Sep-2019, the patient underwent anatomy ultrasound scan and no MCM was noted.   On 11-Sep-2019, approximately at 20 weeks of gestation, the patient was administered Flucelvax QIV [influenza vaccine, subunit influenza virus vaccine polyvalent; batch number: 261200; dose, route of administration, anatomical location and expiration date: not reported] (explicitly coded as Vaccine exposure during pregnancy') for an unknown indication.   On 23-Oct-2019, the patient developed anaemia and was treated with Iron, at single dose, intravenous and Ferralet 90 (ascorbic acid, cyanocobalamin, docusate sodium, ferrous gluconate, folic acid, iron pentacarbonyl), at dose of one tablet, orally, every day.   On 06-Nov-2019 the patient developed cholestasis and was treated with Actigall (ursodeoxycholic acid) at dose of 300 mg, one capsule every four hours, orally.  On 08-Nov-2019, glucose tolerance test was abnormal.   On 20-Nov-2019, liver enzymes were elevated.   Outcome of the events of cholestasis, anemia, abnormal glucose tolerance test and elevated liver enzymes was not recovered. Outcome of the events of prenatal screening test abnormal and vaccine exposure during pregnancy was not reported.   The event of prenatal screening test abnormal and cholestasis were considered serious due to the criterion of medical significance.  The reporter did not provide causality assessment.  Company comment: The patient experienced cholestasis and glucose tolerance test abnormal, 1 month and 26 days after vaccination with Flucelvax QIV, administered at approximately 20 weeks of gestation. The patient also experienced anaemia 1 month 12 days after vaccination and hepatic enzyme increased 2 months after. Although causality was confounded by medical history of obesity, chronology is plausible and causality is assessed as related to these events. Reportedly, one month before vaccination, results were positive for open spina bifida. Chronology is implausible and causality is assessed as not related for prenatal screening test abnormal. Vaccine exposure during pregnancy as not related to suspect vaccine.; Sender's Comments: The patient experienced cholestasis and glucose tolerance test abnormal, 1 month and 26 days after vaccination with Flucelvax QIV, administered at approximately 20 weeks of gestation. The patient also experienced anaemia 1 month 12 days after vaccination and hepatic enzyme increased 2 months after. Although causality was confounded by medical history of obesity, chronology is plausible and causality is assessed as related to these events. Reportedly, one month before vaccination, results were positive for open spina bifida. Chronology is implausible and causality is assessed as not related for prenatal screening test abnormal. Vaccine exposure during pregnancy as not related to suspect vaccine.