Age: 32.0
Sex: F
Vaccine: FLUC4
Symptoms: Beta haemolytic streptococcal infection, Exposure during pregnancy, Streptococcus test positive, Ultrasound antenatal screen normal
Clinical narrative: [+] Group B strep; + Group B strep; Vaccine exposure during pregnancy; This is a serious observational study case, initially received on 02-Jul-2019, concerning a 32-year-old, adult, female pregnant subject (Ethnicity: no data) of body weight: 104 lbs, height: 61 inches and body mass index (BMI): 19.6,  The subject's obstetrical history included two pregnancies both with full term live births. No birth defects were reported. The subject used tobacco during pregnancy that included smoking cigarettes less than 1 packet per day and was still smoking it. 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 drug included Terazol (terconazole) (start date: 25-Jul-2018 and stop date: 30-Jul-2018) for yeast infection. The subject's historical condition included yeast infection (genitourinary) (start date: 20-Jul-2018 and stop date: 17-Oct-2018). The subject's current condition included anxiety. The subject's concomitant medications included Prenatal vitamins [minerals NOS, vitamins NOS] for pregnancy.   The subject's last menstrual period (LMP) date was 11-Jun-2018 and the type of pregnancy was singleton. The subject did not have a prior history of use of alcohol or illicit drugs during pregnancy.  On 12-Jul-2018, the subject undergone fibrosis mutation analysis, spinal muscular atrophy and no major congenital malformations were noted.  On 25-Jul-2018, the subject undergone ultrasound scan and no major congenital malformations were noted.  On 02-Oct-2018, the subject undergone ultrasound scan, quad screen test and no major congenital malformations were noted.  On 17-Oct-2018, at gestational age of approximately 18 weeks, the subject was administered Flu Vaccine Cell Subunit QIV NVD (influenza vaccine, subunit influenza virus vaccine polyvalent, batch number: 252664, dose, route of administration, anatomical location and expiry date and: not reported) (explicitly coded as vaccine exposure during pregnancy) for an unknown indication.   On 21-Dec-2018 and 20-Feb-2019, the subject undergone ultrasound scans and no major congenital malformations were noted.  On 20-Feb-2019, 4 months 3 days after administration of vaccine, the subject was found to be positive for group B streptococcus (bacterial infection due to streptococcus, group B).  On 11-Mar-2019, at gestational age of 39 weeks, the subject gave a live birth to a normal male neonate by vaginal method. The characteristics of neonate included birth weight: 3657 grams, head circumference: 34.3 centimetres and body length: 50.8 centimetres and appearance, pulse, grimace, activity, and respiration (APGAR) scores were 8 at one minute, 9 at five minutes and no data for ten minutes. There was no major congenital malformation identified at birth.   The outcome of the event not recovered.  The subject's estimated date of delivery (EDD) and corrected estimated date of delivery (CEDD) were reported as 18-Mar-2019.; Reporter's Comments: A 32-year-old female pregnant subject experienced bacterial infection due to streptococcus group B, more than 4 months after receipt of Flu vaccine cell subunit QIV NVD. Considering the infectious aetiology of the event, the causal role of inactivated suspect vaccine can be ruled out. The decision to administer a vaccine during pregnancy is related to medical decision making by the mother and her physician and is not related to any property of the medication. The event of exposure during pregnancy was assessed as not related considering the intended use of the vaccine. The company assessed the case as serious (medically significant).