Sex: F
Vaccine: FLUX
Symptoms: Beta haemolytic streptococcal infection, Exposure during pregnancy, Streptococcus test positive
Clinical narrative: Beta haemolytic streptococc (GBS) positive; Vaccine exposure during pregnancy; This is an observational study case, initially received from other health professional  on 25-Nov-2019, concerning a 23-year-old pregnant, female subject of body weight 122 lbs, height 63.3 inches and body mass index (BMI) 21.4, enrolled in a prospective observational safety study. The subject's partner age was 25.  The subject's current condition included mixed anxiety and depressive disorder. The subject's concomitant medications included Ferralet (ascorbic acid, cyanobalamin, docusate sodium, ferrous gluconate, folic acid and iron pentacarbonyl) for pregnancy, Lexapro (escitalopram oxalate) for anxiety and depression and prenatal gummy (minerals NOS, vitamins NOS) as a pregnancy care.  The subject's obstetrical history included one previous full-term live birth pregnancy with no birth defects. The subject had no history of offspring with major congenital malformation (MCM). Also, the subject had no 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 25-Sep-2019. The subject's estimated date of delivery (EDD) and corrected estimated date of delivery (CEDD) were reported as 01-Jul-2020. The type of pregnancy was singleton.   On 12-Nov-2019, the subject underwent ultrasound and no MCMs were noted.  On 19-Nov-2019, at approximately 7 weeks of gestation, the subject was administered Flu Vaccine Egg Split QIV CSL (Afluria QIV) [influenza vaccine, subunit influenza virus vaccine polyvalent, cell cultured derived; batch number: P100126099, dose, route of administration, anatomical location and expiration date: not reported] (explicitly coded as 'Vaccine exposure during pregnancy') for influenza immunisation.   On the same day, after vaccination, it was noted that the subject was group B Streptococcus (GBS) positive. The subject received treatment medication amoxicillin 875 mg at the dose of one tablet, administered every 12 hours, via oral route, for five days.  On 24-Nov-2019, the subject stopped treatment with amoxicillin.  At the time of the initial reporting, the subject had not recovered from the event of bacterial infection due to streptococcus, group B.  The event of bacterial infection due to streptococcus, group B was considered serious due to the criterion of medical significance.  The reporter did not provide causality assessment.  Company Comment: The subject experienced beta haemolytic streptococcal infection on the same day, after vaccination with the suspect product, Afluria QIV. Reportedly, vaccination occurred during pregnancy at 7 weeks of gestation. Chronology is unsuggestive due to very short onset latency for reaction. Pregnant state may have contributed to development of the event. Causality was also confounded by therapy with concomitant medication, Lexapro (escitalopram oxalate). Vaccine exposure during pregnancy is assessed as not related per company's conventions. Considering all the above mentioned, causality between suspect product and the event beta haemolytic streptococcal infection is assessed as unlikely related.; Sender's Comments: The subject experienced beta haemolytic streptococcal infection on the same day, after vaccination with the suspect product, Afluria QIV. Reportedly, vaccination occurred during pregnancy at 7 weeks of gestation. Chronology is unsuggestive due to very short onset latency for reaction. Pregnant state may have contributed to development of the event. Causality was also confounded by therapy with concomitant medication, Lexapro (escitalopram oxalate). Vaccine exposure during pregnancy is assessed as not related per company's conventions. Considering all the above mentioned, causality between suspect product and the event beta haemolytic streptococcal infection is assessed as unlikely related.