Age: 28.0
Sex: F
Vaccine: UNK
Symptoms: Beta haemolytic streptococcal infection, Exposure during pregnancy, Streptococcus test positive
Clinical narrative: Vaccine exposure during pregnancy; Group B Strep Positive; This is an observational pregnancy study case, initially received from other health professional on 27-Feb-2020, concerning a 28-year-old, female, pregnant subject of body weight: 178 lbs, height: 62 inches and body mass index (BMI): 32.6, enrolled in a prospective observational study.  The subject's current medical conditions included herpes simplex virus infection and obesity.     The subject's concomitant medication included Prenatal vitamins (minerals nos, vitamins nos) for pregnancy and Valtrex (valaciclovir hydrochloride) for herpes simplex virus.    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 21-Mar-2019, the estimated delivery date (EDD) was reported as 26-Dec-2019, while corrected estimated date of delivery (CEDD) was not reported. The type of pregnancy was singleton.   On 15-May-2019, the subject underwent ultrasound scan and no MCM was noted.  On 18-Jun-2019, the subject underwent sequential one and nuchal translucency and no MCM was noted.   On 16-Jul-2019, the subject underwent sequential two and no MCM was noted.   On 13-Aug-2019, the subject underwent targeted ultrasound and no MCM was noted.   On 23-Oct-2019, at 30.9 weeks, 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 in 2019, an unknown amount of time after vaccination, the subject tested positive for group B strep (GBS), as reported.   At 39.3 weeks of gestation, the subject gave a live birth to a male neonate, delivered vaginally. The neonate's birth weight was 2807 grams, head circumference and body length were not reported. The appearance, pulse, grimace, activity and respiration (APGAR) scores were 9 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, the 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: A pregnant subject was positive for group B strep an unknown amount of time after vaccination with the suspect product Afluria QIV. Chronology needs more clarification. With information available, for the event Beta haemolytic streptococcal infection, 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 was positive for group B strep an unknown amount of time after vaccination with the suspect product Afluria QIV. Chronology needs more clarification. With information available, for the event Beta haemolytic streptococcal infection, 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.