Sex: F
Vaccine: TDAP, 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 study case, initially received from other health professional on 21-Nov-2019, concerning a 28-year-old, female pregnant subject of body weight: 125 lbs, height: 65 inches and body mass index (BMI): 20.8, enrolled in, a prospective observational safety study.  The subject was primigravida and had no obstetrical history. The subject had no relevant maternal and paternal medical history. The subject did not use tobacco, alcohol or illicit drugs during pregnancy.  The subject's current condition included anxiety.  The subject's concomitant medications included Prenatal vitamins [minerals nos; vitamins nos], indication reported as vitamins.  The subject's last menstrual period (LMP) date was 18-Feb-2019. The subject's estimated date of delivery (EDD) was reported as 25-Nov-2020 and corrected estimated date of delivery (CEDD) was reported as 25-Nov-2020. The type of pregnancy was singleton.   On 20-May-2019, the subject underwent first trimester screen and nuchal translucency scan and no major congenital malformations (MCM) was noted.   On 13-Jun-2019, the subject underwent MSAFP (maternal serum alpha-fetoprotein)/serum markers screening and second trimester screen and no MCM was noted.  On 03-Jul-2018, the subject underwent anatomy ultrasound and no MCM was noted.   On 10-Sep-2019, at 29 weeks of gestation, the subject was administered Flucelvax QIV [influenza vaccine, subunit influenza virus vaccine polyvalent, batch number: 2612001; dose, expiration date, route of administration, anatomical location: not reported] (explicitly coded as vaccine exposure during pregnancy) for influenza immunization.  On the same day, the subject was also administered TDAP [diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid; dose: 0.5 ml; route of administration: intramuscular; batch number, anatomical location, expiration date: not reported], indication reported as vaccine.   On 31-Oct-2019, one month and 21 days after vaccination, the subject was positive for Streptococcus Group B.   At the time of initial reporting the event was still ongoing.  Causality assessment per reporter was not provided.  The event of group B streptococcus positive was considered serious due to the criterion of medical significance.  Company Comment: The subject experienced Beta haemolytic streptococcal infection one month and 21 days after vaccination with the suspect product, Flucelvax QIV. Reportedly, vaccination occurred during pregnancy at 29 weeks of gestation. Chronology is unsugeestive due to long onset latency of the event. Medical history of pregnant state and anxiety may have contributed to development of the event. Co-suspect product TDAP (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid) may provide alternative aetiology for the event. Vaccine exposure during pregnancy is assessed as not related per company's conventions. For the event Beta haemolytic streptococcal infection, causal role of the suspect product cannot be totally excluded and is assessed as unlikely related.; Sender's Comments: The subject experienced Beta haemolytic streptococcal infection one month and 21 days after vaccination with the suspect product, Flucelvax QIV. Reportedly, vaccination occurred during pregnancy at 29 weeks of gestation. Chronology is unsugeestive due to long onset latency of the event. Medical history of pregnant state and anxiety may have contributed to development of the event. Co-suspect product TDAP (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid) may provide alternative aetiology for the event. Vaccine exposure during pregnancy is assessed as not related per company's conventions. For the event Beta haemolytic streptococcal infection, causal role of the suspect product cannot be totally excluded and is assessed as unlikely related.