Age: 27.0
Sex: F
Vaccine: FLUX
Symptoms: Alpha 1 foetoprotein normal, Beta haemolytic streptococcal infection, Caesarean section, Exposure during pregnancy, Gestational hypertension
Clinical narrative: Pre-Eclampsia; Pregnancy induced hypertension/gestational hypertension; Group B Strep positive/GBB+; Vaccine exposure during pregnancy; Failure to progress in second stage; This is an observational study case from, initially received from other health professional on 17-Aug-2020, concerning a 27-year-old female, pregnant subject whose body weight and height were not reported and body mass index (BMI) was above 30, who was enrolled in, a prospective observational safety study.  The subject's past medical history included influenza like symptoms. The subject's current medical history included obesity and the subject was varicella non-immune.  The subject's past medication included Tamiflu (oseltamivir phosphate) for influenza like symptoms. The subject's concomitant medications included Prenatal vitamin (unspecified minerals and vitamins) as vitamin and Tdap (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid) as vaccine.  The subject's obstetrical history noted one previous pregnancy with spontaneous abortion. The subject had no history of offspring with major congenital malformation (MCM) nor relevant maternal history with MCM, but paternal history with MCM included father of baby's second cousin had Down syndrome. The subject did not consume tobacco, alcohol or illicit drugs during pregnancy.  The subject's last menstrual period (LMP) was on 18-Oct-2019, estimated delivery date (EDD) and corrected estimated date of delivery (CEDD) were both reported as 24-Jul-2020. The type of pregnancy was singleton.  On 09-Dec-2019, the subject underwent ultrasound dating scan and no MCM was noted.  On 18-Dec-2019, at gestational age of 8 weeks (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 expiry date: not reported] (explicitly coded as Vaccine exposure during pregnancy') for influenza immunisation.  On 16-Jan-2020, the subject underwent nuchal translucency, first trimester screen and ultrasound. No MCM was noted.  On 12-Feb-2020, the subject underwent second trimester screen and maternal serum alpha-fetoprotein (MSAFP/serum markers) test. No MCM was noted.  On 28-Feb-2020, the subject underwent anatomy ultrasound and no MCM was noted.  On 01-Jul-2020, six months and 13 days after vaccination, the subject was group B streptococcus (Strep) positive.  On 10-Jul-2020, six months and 22 days after vaccination, the subject developed pregnancy induced hypertension/gestational hypertension.  On an unknown date, unknown amount of time after vaccination, the subject developed pre-eclampsia.  On an unknown day in Jul-2020, the subject experienced failure to progress in second stage.  On 19-Jul-2020, at gestational age of 39.3 weeks (as reported), the subject delivered a male neonate by caesarean method. The birth weight of the neonate was 3345 g, head circumference and length were not reported. 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. Pregnancy was complicated with foetal intolerance of labour. On the same day, the subject recovered from gestational hypertension.   At the time of initial reporting the outcome of the event bacterial infection due to streptococcus, group B' was not resolved, while the outcome of the events prolonged second stage of labour' and pre-eclampsia was not reported.  Per company, the events of bacterial infection due to streptococcus, group B', prolonged second stage of labour' and pre-eclampsia were considered serious due to criterion of medical significance.  The reporter did not provide a causality assessment to Flucelvax QIV.  This case is linked to case 202004112 (the corresponding child case).  Company comment: A pregnant subject was administered Flucelvax QIV. The subject experienced Beta haemolytic streptococcal infection, pre-eclampsia, gestational hypertension and prolonged labour, approximately six months after vaccination. Chronology is unsuggestive. Causality is assessed as not related for Beta haemolytic streptococcal infection and prolonged labour, due to biological/pharmacological implausibility. Regarding the events of pre-eclampsia and gestational hypertension, causality was confounded by subject's current medical history included obesity. 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 Beta haemolytic streptococcal infection, pre-eclampsia, gestational hypertension and prolonged labour, approximately six months after vaccination. Chronology is unsuggestive. Causality is assessed as not related for Beta haemolytic streptococcal infection and prolonged labour, due to biological/pharmacological implausibility. Regarding the events of pre-eclampsia and gestational hypertension, causality was confounded by subject's current medical history included obesity. Vaccine exposure during pregnancy assessed as not related per company's conventions.