Age: 34.0
Sex: F
Vaccine: FLUC4
Symptoms: Complication of pregnancy, Delivery, Eclampsia, Exposure during pregnancy, Foetal biophysical profile score normal
Clinical narrative: Eclampsia; Chronic hypertension in obstetrics; Vaginitis; Urinary tract infection; Vaccine exposure during pregnancy; This is an observational study case, initially received from other health professional on 16-Jul-2020, concerning a 34-year-old female, pregnant subject of body weight: 130.8 lbs, height: 64 inches and body mass index (BMI): 22.4, who was enrolled in, a prospective observational safety study on pregnancy outcomes in women immunized with seasonal cell culture influenza trivalent (TIVc) or quadrivalent (QIVc) vaccine during pregnancy.   The subject's medical history included migraines, past history of severe pre-eclampsia, poor obstetric history, past history of deep vein thrombosis, past history of cholestasis, anxiety depression and nausea.  The subject's concomitant medications included: Lexapro (escitalopram oxalate) for anxiety, Vitafol gummies (unspecified vitamins and minerals) as vitamin, Fioricet (butalbital, caffeine, paracetamol) for migraines, Diclegis (doxylamine succinate, pyridoxine hydrochloride) for nausea and Tdap (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid) as vaccine.  The subject's obstetrical history included nine previous pregnancies with three full term live births, one preterm live birth, one elective abortion and four spontaneous abortions. The subject had no history of offspring with major congenital malformation (MCM) and no relevant 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 04-Aug-2019. The subject's estimated delivery date (EDD) and corrected estimated date of delivery (CEDD) were reported as 10-May-2020. The type of pregnancy was singleton.  On 08-Oct-2019, the subject underwent ultrasound dating and no MCM was noted.  On 13-Nov-2019, at gestational age of 14 weeks (calculated per LMP), the subject received Flucelvax QIV (Flu Vaccine Cell Subunit QIV NVD) [influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, batch number: 261223, route of administration, anatomical location and expiry date: not reported] (explicitly coded as Vaccine exposure during pregnancy') for influenza immunisation.  On 18-Dec-2019, the subject underwent anatomy ultrasound and no MCM was noted.  On 31-Dec-2019, the subject underwent second trimester screen and quad test. No MCM was noted.  On 22-Jan-2020, two months and nine days after vaccination, the subject developed urinary tract infection (UTI) and started treatment with Macrobid (nitrofurantoin) at dose of 100 mg, every 12 hours via oral route of administration.  On 28-Jan-2020, the subject recovered from UTI and finished treatment with Macrobid.  On 04-Mar-2020, three months and 20 days after vaccination, the subject developed vaginitis and started treatment with Diflucan (fluconazole) at dose of one tablet, once via oral route of administration and to repeat after 72 hours.   On 06-Mar-2020, the subject finished treatment with Diflucan.  On 24-Mar-2020, four months and 11 days after vaccination, the subject developed chronic hypertension in obstetric.  On 26-Mar-2020, the subject underwent ultrasound biophysical profile and no MCM was noted.  On 23-Apr-2020, the subject underwent ultrasound biophysical profile and no MCM was noted.  On an unspecified date, eclampsia was noted as pregnancy complication.  At gestational age of 39 weeks (as reported), the subject delivered a male neonate by vaginal method. The neonate's birth weight was 3487 g, while head circumference and length were not provided. Appearance, pulse, grimace, activity and respiration (APGAR) score at one minute was 8 and at five minutes was 9. APGAR score at ten minutes was not provided. No MCM was identified at birth.   At the time of initial reporting, the outcome of the event 'gestational hypertension' was not resolved, while the outcome of the events eclampsia and vaginitis was not reported.  Per company, the events of urinary tract infection and eclampsia were considered serious due to criterion of medical significance.  The reporter did not provide a causality assessment to Flucelvax QIV.  Company comment: A pregnant subject was administered Flucelvax QIV. The subject experienced urinary tract infection, vaginal infection, chronic hypertension and eclampsia in months following vaccination. UTIs are common during pregnancy, because growing uterus makes pressure on the bladder and urinary tract. The subject's past medical history included severe pre-eclampsia, deep vein thrombosis, cholestasis, therefore causality was highly confounded for chronic hypertension and eclampsia. Causal role of the suspect vaccine is assessed as not related for all events, due to presented confounders, biological implausibility and unsuggestive chronology. Vaccine exposure during pregnancy assessed as not related per company's conventions.; Sender's Comments: A pregnant subject was administered Flucelvax QIV. The subject experienced urinary tract infection, vaginal infection, chronic hypertension and eclampsia in months following vaccination. UTIs are common during pregnancy, because growing uterus makes pressure on the bladder and urinary tract. The subject's past medical history included severe pre-eclampsia, deep vein thrombosis, cholestasis, therefore causality was highly confounded for chronic hypertension and eclampsia. Causal role of the suspect vaccine is assessed as not related for all events, due to presented confounders, biological implausibility and unsuggestive chronology. Vaccine exposure during pregnancy assessed as not related per company's conventions.