Age: 23.0
Sex: F
Vaccine: UNK
Symptoms: Alpha 1 foetoprotein normal, Beta haemolytic streptococcal infection, Complication of pregnancy, Delivery, Exposure during pregnancy
Clinical narrative: Group B strep; Vaccine exposure during pregnancy; This is an observational study case initially received from other health professional on 07-Jul-2020, concerning a 23-year-old, female pregnant subject of body weight: 261 lbs, height: 70.5 inches and body mass index (BMI) 36.9, enrolled in a prospective observational safety study.  The subject's medical history included obesity.  The subject's concomitant medications included Prenatal vitamins (unspecified vitamins and minerals) as vitamin and TDAP vaccine (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid) for vaccination.  The subject had no previous pregnancies. The subject had no maternal or paternal history with MCM. The subject had no history of offspring with MCM. The subject did not use tobacco, alcohol or illicit drugs during pregnancy.   The subject's last menstrual period (LMP) date was on 16-Jul-2019. The type of pregnancy was singleton. The subject's estimated delivery date (EDD) was reported as 21-Apr-2020 and corrected estimated delivery date (CEDD) was reported as 14-Apr-2020.   On 14-Oct-2019, the subject underwent first trimester screen and ultrasound and no MCMs were noted.  On 29-Oct-2019, at approximately 15 weeks of gestation (calculated per LMP), the subject was administered Flucelvax QIVc (Flu Vaccine Cell Subunit QIV NVD) [influenza vaccine, subunit influenza virus vaccine polyvalent, batch number: 261223, dose: 0.5 ml, route of administration, anatomical location and expiry date: not reported) (explicitly coded as Vaccine exposure during pregnancy') for an influenza immunisation.  On the same day, the subject underwent second trimester screen and maternal serum alpha-fetoprotein (MSAFP)/ serum markers and no MCMs were noted.  On 20-Nov-2019, the subject underwent anatomy ultrasound and no MCMs were noted.   On 20-Mar-2020, the subject developed bacterial infection due to streptococcus, group B' (reported as group B strep') as pregnancy complication.  On 08-Apr-2020, the subject underwent growth scan and no MCMs were noted.  At 41.1 weeks of gestation (as reported), the subject vaginally delivered a live, male neonate. The neonate's birth weight was 4252 g, while 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 for 10 minutes was not reported. No MCMs were identified at birth.  At the time of initial reporting, the outcome for event of bacterial infection due to streptococcus, group B' was not resolved.  The event of bacterial infection due to streptococcus, group B' was considered as serious due to criterion of medical significance.  The reporter did not provide the causality assessment to Flucelvax QIV.  This case is linked to case 202003848 (the corresponding baby case).  Company comment: A 23-year-old pregnant subject was administered Flucelvax QIVc at gestational age of 15 weeks. The subject developed Beta haemolytic streptococcal infection 4 months 20 days after vaccination. Considering unsuggestive temporal relationship and biological implausibility, causality between suspect product and the event is assessed as not related. Vaccine exposure during pregnancy is not related per company's conventions.; Sender's Comments: A 23-year-old pregnant subject was administered Flucelvax QIVc at gestational age of 15 weeks. The subject developed Beta haemolytic streptococcal infection 4 months 20 days after vaccination. Considering unsuggestive temporal relationship and biological implausibility, causality between suspect product and the event is assessed as not related. Vaccine exposure during pregnancy is not related per company's conventions.