Sex: F
Vaccine: UNK
Symptoms: Cholestasis, Exposure during pregnancy
Clinical narrative: Cholestasis; Vaccine exposure during pregnancy; This is an observational pregnancy study case initially received from other health professional on 31-Oct-2019, concerning a 26-year-old, adult, female pregnant subject of body weight: 146 lbs, height: 67 inches and body mass index (BMI): 22.9, enrolled in a prospective observational study.   The subject's current condition included bacterial infection due to streptococcus, group B. The subject's concomitant medication included Prenatal (minerals nos, vitamins nos) as a vitamin.  The subject's obstetrical history included 2 previous pregnancies with 1 full term live birth and 1 spontaneous abortion. The subject did not have a history of offspring with major congenital malformation. The paternal risk factor included father of baby maternal cousin  mental retardation, while the subject had no maternal history of offspring with major congenital malformations.  The subject's last menstrual period (LMP) date was 31-Mar-2019, estimated delivery date (EDD) and corrected estimated date of delivery (CEDD) were reported as 05-Jan-2020.  The subject did not use tobacco, alcohol or illicit drugs during pregnancy. On an unknown date, the pregnancy status was collected, and no pregnancy complications were noted. The type of pregnancy was singleton.  On 26-Jun-2019, the subject underwent first trimester screen and nuchal translucency and no major congenital malformation (MCM) was noted.   On 26-Jul-2019, the subject underwent second trimester screen-alpha fetoprotein test (AFP) and no MCM was noted.   On 15-Aug-2019, the subject underwent anatomy ultrasound and no MCM was noted.   On 19-Sep-2019, at 24 weeks of gestation, the subject was administered Flucelvax QIVc (influenza vaccine, subunit influenza virus vaccine polyvalent; batch number: 261200, dose, route of administration, expiry date and anatomical location: not reported] for influenza immunisation (explicitly coded as Vaccine exposure during pregnancy').  On 21-Oct-2018, 1 month and 2 days after vaccination, the subject developed cholestasis and was treated with ursodiol, one tablet, three times a day, administered orally.    At the time of initial reporting, the outcome of the event cholestasis was not reported.  The case was assessed as serious and the reporter did not provide causality assessment to Flucelvax (QIV).  Company comment: The subject experienced cholestasis after vaccination with the suspect product Flucelvax QIVc. Reportedly, vaccination occurred during pregnancy. Chronology is plausible. Pregnant state may provide more plausible alternative aetiology for the event. Vaccine exposure during pregnancy is assessed as not related per company's conventions. For the event cholestasis, causal role of the suspect product cannot be totally excluded and is assessed as unlikely related.; Sender's Comments: The subject experienced cholestasis after vaccination with the suspect product Flucelvax QIVc. Reportedly, vaccination occurred during pregnancy. Chronology is plausible. Pregnant state may provide more plausible alternative aetiology for the event. Vaccine exposure during pregnancy is assessed as not related per company's conventions. For the event cholestasis, causal role of the suspect product cannot be totally excluded and is assessed as unlikely related.