Age: 30.0
Sex: F
Vaccine: UNK
Symptoms: Beta haemolytic streptococcal infection, Delivery, Exposure during pregnancy, Streptococcus test positive
Clinical narrative: Group B Strep; Positive group B Strep; Vaccine exposure during pregnancy; This is a serious observational study case, initially received from other health professional on 07-Jun-2019, concerning a 30-year-old adult female, pregnant subject , of body weight: 147 lbs, height: 62 inches and body mass index (BMI): 26.9, 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 obstetrical history included 2 previous pregnancies with full-term live births and no birth defects were reported. The subject had no history of offspring with major congenital malformation. Also, the subject had no maternal or paternal history with major congenital malformations. The subject's historical condition included candidiasis and vaginitis. The subject's historical drugs included Terconazole for candidiasis and Flagyl for vaginitis. The subject's current condition included nausea. The subject's concomitant medication included Prenatal vitamins (minerals nos, vitamins nos) for pregnancy and Diclegis (doxylamine succinate, pyridoxine hydrochloride) and Bonjesta (doxylamine succinate, pyridoxine hydrochloride) for nausea.    The subject's last menstrual period (LMP) date was 06-Jun-2018. The type of pregnancy was singleton. The subject did not have a prior history of use of tobacco, alcohol or illicit drugs during pregnancy. The subject's pregnancy status was collected, and no pregnancy complications were noted.  On 14-Aug-2018, the subject underwent cystic fibrosis mutation analysis, spinal muscular atrophy screening, haemoglobin electrophoresis and no major congenital malformations were noted. On 24-Aug-2018, the subject underwent ultrasound screening and no major congenital malformations were noted. On 26-Sep-2018, the subject underwent ultrasound screening and maternal serum alpha-fetoprotein (MSAFP)/serum markers test and no major congenital malformations were noted.  On 29-Oct-2018, at approximately 20 weeks gestation, the subject was administered Flu Vaccine Cell Subunit QIV NVD (batch number: 252664, dose, route of administration, anatomical location, batch number and expiry date: not reported) (explicitly coded as vaccine exposure during pregnancy) for an unknown indication.  On 15-Feb-2019, 3 months and 17 days after vaccination, the subject was found to be positive for group B streptococcus (bacterial infection due to streptococcus, group B).  at approximately 39.1 weeks gestation, the subject gave a live birth to a normal female neonate vaginally. The characteristics of the neonate included birth weight: 3260 grams, head circumference: 33 cm, body length: 50 cm and APGAR (appearance, pulse, grimace, activity, and respiration) scores were 9 at one minute and five minutes. No major congenital malformations (MCMs) were identified at birth and no pregnancy complications were noted.  The outcome of the event bacterial infection due to streptococcus, group B' was not recovered (reported as ongoing).  The subject's estimated delivery date (EDD) and corrected estimated date of delivery (CEDD) were reported as 13-Mar-2019.; Reporter's Comments: A 30-year-old pregnant subject was diagnosed with positive for group B streptococcus (bacterial infection due to streptococcus, group B), 3 months 17 days after receipt of Flu Vaccine Cell Subunit QIV (considered as vaccine exposure during pregnancy). Considering the infective aetiology (bacterial) of the event positive for group B streptococcus (bacterial infection due to streptococcus, group B), the causality assessed as not related to inactivated study vaccine. The event vaccine exposure during pregnancy assessed as not related considering the intended use of the vaccine. The company assessed the event 'bacterial infection due to streptococcus, group B' as serious (medically significant).