Age: 29.0
Sex: F
Vaccine: UNK
Symptoms: Atrioventricular block first degree, Delivery, Eclampsia, Exposure during pregnancy, Ocular myasthenia
Clinical narrative: Eclampsia; Pre-eclampsia; Ocular myasthenia gravis; First degree AV block; Vaccine exposure during pregnancy; This is an observational study case, initially received from other health professional on 31-Jan-2020, concerning a 29-year-old, female pregnant subject of body weight: 259 lbs, height: 62.5 inches and body mass index (BMI): 46.6 enrolled in a prospective observational safety study.  The subject's current conditions included body mass index high, anxiety and depression.   The subject's concomitant medications included Prenatal vitamins (minerals nos; vitamins nos) as obstetrical care.  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 01-May-2019. The subject's estimated delivery date (EDD) and corrected estimated date of delivery (CEDD) were 05-Feb-2020. The type of pregnancy was singleton.   On 26-Jul-2019, the subject underwent first trimester screen test and no MCM was noted.  On 23-Aug-2019, the subject underwent maternal serum alpha fetoprotein (MSAFP) / serum markers and no MCM was noted.  On 16-Sep-2019, the subject underwent anatomy ultrasound and no MCM was noted.  On 18-Oct-2019, at gestational age of 24 weeks, the subject was administered with Flu Vaccine Cell Subunit QIV NVD (Flucelvax QIVc) [influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, batch number: 261223, anatomical location, route of administration and expiration date: not reported] (explicitly coded as Vaccine exposure during pregnancy') for influenza immunisation.   On an unspecified date, an unknown amount of time after vaccination, the subject developed eclampsia, severe pre-eclampsia, ocular myasthenia gravis and first-degree AV block.  At gestational age of 37.9 weeks, the subject vaginally delivered live birth, male neonate. The neonate's birth weight was 2892 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).  No MCM was noted at birth.  At the time of this report, the outcome of the events eclampsia, severe pre-eclampsia, ocular myasthenia gravis and first-degree AV block was not reported.  The events of eclampsia, severe pre-eclampsia, ocular myasthenia gravis and first-degree AV block were assessed as serious due to criterion of medical significance, per company.  The reporter did not provide causality assessment to Flucelvax QIV.  Company comment: The subject experienced eclampsia, pre-eclampsia, myasthenia gravis and atrioventricular block first degree after vaccination with the suspect product, Flucelvax QIVc. Reportedly, vaccination occurred during pregnancy at gestational age of 24 weeks. Chronology is very unclear. Pregnant state may provide alternative aetiology for the events eclampsia and pre-eclampsia. Medical history of obesity (body mass index 46.6) anxiety and depression may have contributed to development of the events. Vaccine exposure during pregnancy is assessed as not related per company's conventions. Limited and unclear reported information concerning the events eclampsia, pre-eclampsia, myasthenia gravis and atrioventricular block first degree precludes thorough causality assessment, therefore causality for the events is unassessable.; Sender's Comments: The subject experienced eclampsia, pre-eclampsia, myasthenia gravis and atrioventricular block first degree after vaccination with the suspect product, Flucelvax QIVc. Reportedly, vaccination occurred during pregnancy at gestational age of 24 weeks. Chronology is very unclear. Pregnant state may provide alternative aetiology for the events eclampsia and pre-eclampsia. Medical history of obesity (body mass index 46.6) anxiety and depression may have contributed to development of the events. Vaccine exposure during pregnancy is assessed as not related per company's conventions. Limited and unclear reported information concerning the events eclampsia, pre-eclampsia, myasthenia gravis and atrioventricular block first degree precludes thorough causality assessment, therefore causality for the events is unassessable.