Age: 22.0
Sex: F
Vaccine: FLUX
Symptoms: Beta haemolytic streptococcal infection, Delivery, Exposure during pregnancy, Neonatal disorder, Streptococcus test positive
Clinical narrative: Group B Streptococcus positive; Vaccine exposure during pregnancy; This is an observational study case from, initially received from other health professional on 09-Dec-2019, concerning a 22-year-old, female pregnant subject of body weight: 116 lbs, height: 62 inches and body mass index (BMI): 21.2 enrolled in, a prospective observational safety study.  The subject's historical condition included bacterial vaginosis.  The subject historical drug included metronidazole for bacterial vaginosis.  The subject's concomitant medication included Prenatal pixie plus iron (vitamins and minerals) as vitamin and Tdap (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid) as vaccine.   The subject's obstetrical history noted that subject had one previous pregnancy with one spontaneous abortion. The subject had no history of offspring with major congenital malformation (MCM) and no relevant maternal and paternal medical history. The subject did not use tobacco, illicit drug or alcohol during pregnancy.  The subject's last menstrual period (LMP) date was 03-Mar-2019. The subject's estimated delivery date (EDD) was 08-Dec-2019 and corrected estimated date of delivery (CEDD) was 14-Dec-2019. The type of pregnancy was singleton.   On 10-Jun-2019, the subject underwent first trimester screen test and no MCM was noted.  On 26-Jun-2019, the subject underwent mother serum alpha fetoprotein (MSAFP) / serum markers test and no MCM was noted.  On 25-Jul-2019, the subject underwent anatomy ultrasound and no MCM was noted.  On 16-Oct-2019, at gestational age at 32 weeks, the subject was administered  Flucelvax QIVc (Flu Vaccine Cell Subunit QIV NVD) [influenza vaccine, subunit influenza virus vaccine polyvalent, batch number: 261200, dose: 0.5 ml, anatomical location, route of administration and expiration date: not reported] (explicitly coded as Vaccine exposure during pregnancy') for influenza immunisation.  On 04-Nov-2019, the subject underwent ultrasound and no MCM was noted.  On 20-Nov-2019, one moths and four days after vaccination, the subject was positive to group B streptococcus bacteria.  On 17-Dec-2019, at gestational age of 40.4 weeks, the subject vaginally delivered live birth, male neonate. The neonate's birth weight was 2637 g, his head circumference and length were not provided. The appearance, pulse, grimace, activity, and respiration (APGAR) scores were 1 (one minute), 4 (five minutes) and 8 (ten minutes). The neonate was sent to Neonatal intensive care unit (NICU) due to thick meconium and respiratory distress.    On the same day, the subject recovered from bacterial infection due to streptococcus, group B.  The event of bacterial infection due to streptococcus, group B' was assessed as serious due to criterion of medical significance, per company.  The causality assessment was not provided.  This case is linked to 202001870, the corresponding child case.  Follow up received from other health professional on 19-Feb-2020 with additional information received on the same day (being process together): Pregnancy details updated (date and type of delivery, birth type and foetal outcome populated). Details regarding neonate added (body weight and APGAR scores added). TDAP changed from historical vaccine to concomitant medication. The stop date for bacterial infection due to streptococcus, group B was provided. The narrative was amended accordingly.  Company Comment: The subject experienced beta haemolytic streptococcal infection after vaccination with the suspect product, Flu Vaccine Cell Subunit QIV NVD. Reportedly, vaccination occurred during pregnancy at 32 weeks of gestation. Chronology is plausible. Pregnant state and exposure to infective agent may provide alternative aetiology for the event. Non-company vaccine   Tdap (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid) also confounds causality in significant way. Vaccine exposure during pregnancy is assessed as not related per company's conventions. Causality between suspect product and the event beta haemolytic streptococcal infection is assessed as unlikely related (defaults to related for reporting purposes).; Sender's Comments: The subject experienced beta haemolytic streptococcal infection after vaccination with the suspect product, Flu Vaccine Cell Subunit QIV NVD. Reportedly, vaccination occurred during pregnancy at 32 weeks of gestation. Chronology is plausible. Pregnant state and exposure to infective agent may provide alternative aetiology for the event. Non-company vaccine   Tdap (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid) also confounds causality in significant way. Vaccine exposure during pregnancy is assessed as not related per company's conventions. Causality between suspect product and the event beta haemolytic streptococcal infection is assessed as unlikely related (defaults to related for reporting purposes).