Age: 20.0
Sex: F
Vaccine: UNK
Symptoms: Alpha 1 foetoprotein normal, Caesarean section, Exposure during pregnancy, Gestational diabetes, Hypertension
Clinical narrative: Hypertension; Delivery at 34.1 weeks of gestation; Pre-eclampsia in the 3rd trimester; Gestational diabetes mellitus; Vaccine exposure during pregnancy; This is an observational study case, initially received from other health professional on 25-Mar-2020, concerning an 20-year-old female, pregnant subject of body weight: 309 lbs, height: 67 inches and body mass index (BMI): 48.4, enrolled in a prospective observational study.  The subject's past medical history included history of pre-term delivery (G1 and G3), history of severe pre-eclampsia (G1 and G3) and infection due to Escherichia coli (E-Coli). The subject's current medical history included severely obese with body mass index 40+.  The subject's past medications included cefprozil for infection due to E-coli. The subject's concomitant medications included Tdap (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid) as vaccination.  The subject's obstetrical history included three pregnancies, two with preterm live births and one with spontaneous abortion. The subject had no history of offspring with major congenital malformation (MCM). Also, the subject had no maternal or paternal history with MCM. The subject did not use tobacco, alcohol or illicit drugs during pregnancy.  The subject's last menstrual period (LMP) date was 23-Jul-2019. Type of pregnancy was singleton. The subject's estimated date of delivery (EDD) and corrected estimated date of delivery (CEDD) were reported as 28-Apr-2020.  On 21-Oct-2019, the subject underwent initial ultrasound and first trimester screen, no MCM was noted.  On 18-Nov-2019, at approximately 16 weeks of gestation (calculated per LMP), the subject was administered Flucelvax QIV (Flu Vaccine Cell Subunit QIV NVD) [Influenza vaccine, subunit influenza virus vaccine polyvalent; batch number: 261223, dose: 0.5 mL, 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 maternal serum alpha-fetoprotein (MSAFP/serum markers) and second trimester screen, no MCM was noted.  On an unspecified date, the subject developed hypertension.  On 26-Dec-2019, the subject underwent anatomy ultrasound, no MCM was noted.  On 17-Jan-2020, the subject started treatment with ASA (acetiylsalicylic acid), 81 mg, every day (qd), oral, for hypertension.  On 29-Jan-2020, the subject developed gestational diabetes mellitus.  On 11-Feb-2020, the subject underwent follow up growth ultrasound, no MCM was noted.  On 18-Feb-2020, the subject started treatment with metformin, 500 mg, oral, twice a day (bid), for gestational diabetes mellitus.  On 05-Mar-2020, the subject underwent follow up growth ultrasound, no MCM was noted.  On 16-Mar-2020, the subject developed severe pre-eclampsia in the 3rd trimester.  At gestational age 34.1 weeks (as reported), the subject delivered live male neonate via caesarean method of delivery. Neonate's birth weight was 2552 grams, body length: 47.5 cm and head circumference: 34 cm. The appearance, pulse, grimace, activity, and respiration (Apgar) score at one minute: 8, five minutes: 7 and ten minutes: not reported. There was no MCM noted at birth.  On the same day, the outcome of severe pre-eclampsia in the 3rd trimester was resolved.  At the time of this report, the outcome of the event Gestational diabetes mellitus' was not resolved, the outcome of the events Premature delivery' and Hypertension' was not reported.  The events of 'Gestational diabetes mellitus', Premature delivery' and Pre-eclampsia' were assessed as serious due to medically significance per the company.  The reporter did not provide causality assessment.  The case is linked to the case 202002626 (baby case).  Company comment: An 20-year-old female pregnant subject developed gestational diabetes, pre-clampsia, premature delivery, hypertension after vaccination with the suspect product Flucelvax QIV for influenza immunisation. The narrative suggests plausible chronology. The subject's obstetrical history included three pregnancies, two with preterm live births and one with spontaneous abortion. The subject's past medical history included history of pre-term delivery (G1 and G3), history of severe pre-eclampsia (G1 and G3) and infection due to Escherichia coli (E-Coli). The subject's current medical history included severely obese with body mass index 40+. The subject's past medications included cefprozil for infection due to E-coli. The subject's concomitant medications included Tdap (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid) as vaccination. With information presented, causality is assessed as unlikely related for all events. Exposure during pregnancy is assessed as unrelated per company conventions. (''unlikely related'' defaults to "related" in the safety database for reporting purposes); Sender's Comments: An 20-year-old female pregnant subject developed gestational diabetes, pre-clampsia, premature delivery, hypertension after vaccination with the suspect product Flucelvax QIV for influenza immunisation. The narrative suggests plausible chronology. The subject's obstetrical history included three pregnancies, two with preterm live births and one with spontaneous abortion. The subject's past medical history included history of pre-term delivery (G1 and G3), history of severe pre-eclampsia (G1 and G3) and infection due to Escherichia coli (E-Coli). The subject's current medical history included severely obese with body mass index 40+. The subject's past medications included cefprozil for infection due to E-coli. The subject's concomitant medications included Tdap (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid) as vaccination. With information presented, causality is assessed as unlikely related for all events. Exposure during pregnancy is assessed as unrelated per company conventions. (''unlikely related'' defaults to "related" in the safety database for reporting purposes)