Age: 32.0
Sex: F
Vaccine: UNK
Symptoms: Beta haemolytic streptococcal infection, Exposure during pregnancy, Streptococcus test positive
Clinical narrative: Group B Streptococcus positive; Vaccine exposure during pregnancy; This is an observational pregnancy study case, initially received from other health professional on 27-Feb-2020, concerning a 32-year-old, female, pregnant subject of body weight: 145 lbs, height: 64 inches and body mass index (BMI): 24.9, enrolled in a prospective observational study.  The subject's current medical conditions included nausea and vomiting.      The subject's concomitant medications included Bonjesta (doxylamine succinate, pyridoxine hydrochloride) for nausea and vomiting, Prenatal vitamins (unspecified minerals and vitamins) for pregnancy and OB complete (vitamins and minerals) also for pregnancy.   The subject's obstetrical history included one previous pregnancy with one full term live birth. The subject had no maternal or paternal history with major congenital malformations (MCMs). The subject did not use tobacco, alcohol or illicit drugs during pregnancy.  The subject's last menstrual period (LMP) date was 22-Apr-2019, the estimated delivery date (EDD) was reported as 29-Jan-2019 and corrected estimated date of delivery (CEDD) was reported as 18-Jan-2020. The type of pregnancy was singleton.  On 24-Jun-2019, the subject underwent non-invasive prenatal test and no MCM was noted.  On 11-Jul-2019, the subject underwent nuchal translucency and no MCM was noted.  On 07-Aug-2019, the subject underwent maternal serum alpha-fetoprotein screening (MSAFP) / serum markers and no MCM was noted.   On 03-Oct-2019, at approximately 23 weeks of gestation (calculated per LPM), the subject was administered Afluria QIV (Flu Vaccine Egg Split QIV CSL) [influenza vaccine; batch number: P100122488, dose, route of administration, anatomical location and expiry date: not reported] (explicitly coded as 'Vaccine exposure during pregnancy') for influenza immunisation.  On an unspecified date, an unknown amount of time after vaccination, the subject tested positive for group B strep (GBS), as reported.   At 40.3 weeks of gestation (as reported), the subject gave a live birth to a female neonate, delivered vaginally. The neonate's birth weight was 3050 grams, head circumference and body length were not reported. The appearance, pulse, grimace, activity and respiration (APGAR) scores were 8 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 this report outcome of the event bacterial infection due to streptococcus, group B' was not reported.   The event of bacterial infection due to streptococcus, group B' was assessed as serious, due to the criterion of medical significance, per company.   The reporter did not provide causality assessment to Afluria QIV.  Company comment: The patient was administered Afluria QIV at 23 weeks of gestational age (explicitly coded as vaccine exposure during pregnancy) and developed beta haemolytic streptococcal infection on an unspecified date and an unknown amount of time after vaccination. Chronology is unassesable. Underlying pregnancy may have contributed to development of the event. The causality of the event 'vaccine exposure during pregnancy' is assessed as not related to suspect vaccine, while between the suspect product and event of beta haemolytic streptococcal infection is assessed as unlikely related. (defaults to related for reporting purposes).; Sender's Comments: The patient was administered Afluria QIV at 23 weeks of gestational age (explicitly coded as vaccine exposure during pregnancy) and developed beta haemolytic streptococcal infection on an unspecified date and an unknown amount of time after vaccination. Chronology is unassesable. Underlying pregnancy may have contributed to development of the event. The causality of the event 'vaccine exposure during pregnancy' is assessed as not related to suspect vaccine, while between the suspect product and event of beta haemolytic streptococcal infection is assessed as unlikely related. (defaults to related for reporting purposes).