Age: 32.0
Sex: F
Vaccine: UNK
Symptoms: Beta haemolytic streptococcal infection, Delivery, Exposure during pregnancy, Streptococcus test positive
Clinical narrative: Vaccine exposure during pregnancy; Group B Streptococcus positive; This is an observational study case, initially received from other health professional on 27-Feb-2020, concerning a 32-year-old, female pregnant subject of body weight: 266 lbs, height: 69 inches and body mass index (BMI): 39.3, enrolled in a prospective observational safety study on pregnancy outcomes in women immunized with Afluria QIV, a seasonal quadrivalent vaccine, during pregnancy.  The subject's medical history included polycystic ovarian syndrome, chronic hypertension, obesity/BMI increase and low grade squamous intraepithelial lesion of cervix.   The subject's concomitant medications included Prenatal vitamins (unspecified vitamins and minerals) for pregnancy.    The subject had one previous pregnancy with spontaneous abortion. The subject had no history of offspring with major congenital malformation (MCM) and no relevant maternal and paternal medical history. The subject did not use alcohol or illicit drugs during pregnancy, but she did use five cigarettes, per day.   The subject's last menstrual period (LMP) date was 17-Mar-2019. The type of pregnancy was singleton. The subject's estimated date of delivery (EDD) was reported as 22-Dec-2019 and corrected estimated date of delivery (CEDD) was reported as 01-Jan-2020.   On 24-Jun-2019, the subject underwent first sequential test and nuchal translucency ultrasound and no MCM was noted.   On 24-Jul-2019, the subject underwent second sequential test and no MCM was noted.   On 03-Oct-2019, approximately at 27 weeks of gestation, the subject was administered Afluria QIV (Flu Vaccine Egg Split QIV CSL) [influenza vaccine, batch number: P100112488, dose, route of administration, anatomical location and expiration date: not reported] for an influenza immunization (explicitly coded as ''Vaccine exposure during pregnancy'').  On an unknown date in 2019, unknown amount of time after vaccination, the subject was tested positive for group B Streptococcus.   at 39.1 weeks of gestation, the subject vaginally delivered a normal, male neonate of birth weight 3400 grams. The characteristics of neonate such as head circumference and body length were not reported. The appearance, pulse, grimace, activity, and respiration (APGAR) scores were 7 at one minute and 9 at five minutes. APGAR score was not reported for 10 minutes. There was no major congenital malformation identified at birth.  At the time of initial reporting, the outcome was not reported.   The event of bacterial infection due to streptococcus, group B' was considered serious due to the criterion of medical significance, per company.  The reporter did not provide causality assessment to Afluria QIV.  Company Comment: A pregnant subject developed Beta haemolytic streptococcal infection an unknown amount of time after vaccination with the suspect product Afluria QIV. Chronology needs more clarification. With information available, causality is assessed as unlikely related (defaults to "related" in the safety database for reporting purposes). Vaccine exposure during pregnancy is assessed as not related per company conventions.; Sender's Comments: A pregnant subject developed Beta haemolytic streptococcal infection an unknown amount of time after vaccination with the suspect product Afluria QIV. Chronology needs more clarification. With information available, causality is assessed as unlikely related (defaults to "related" in the safety database for reporting purposes). Vaccine exposure during pregnancy is assessed as not related per company conventions.