Age: 22.0
Sex: F
Vaccine: FLUC4
Symptoms: Beta haemolytic streptococcal infection, Delivery, Exposure during pregnancy, Nausea, Pelvic pain
Clinical narrative: Group B Streptococcus positive; Viral syndrome; Pelvic pain; Nausea; Vomiting; Vaccine exposure during pregnancy; This is an observational study case initially received on 20-Jul-2020, concerning a 22-year-old, pregnant, female subject of body weight 218 lbs, height 64 inches and body mass index (BMI) 37.4, enrolled in, a prospective observational safety study on pregnancy outcomes in women immunized with seasonal cell culture influenza trivalent (TIVc) or quadrivalent (QIVc) vaccine during pregnancy.   The subject's current conditions included anxiety, depression, non-immune (as reported) and BMI 30+ with obesity.  The subject's concomitant medication included Prenatal vitamins (unspecified 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 the subject had one previous pregnancy with spontaneous abortion. The subject had no history of offspring with major congenital malformation (MCM). Also, the subject had no paternal history with MCM. The subject had maternal history with MCMs. The subject's first cousin had Down's syndrome. The subject did not use tobacco or alcohol during pregnancy. The subject used cannabis at unknown amount of drug consumed per day but stopped with positive urine pregnancy test.  The subject's last menstrual period (LMP) date was not reported. The subject's estimated delivery date (EDD) was reported as 29-Mar-2020, while corrected estimated date of delivery (CEDD) was reported as 07-Apr-2020. The type of pregnancy was singleton.  On 12-Nov-2019, the subject underwent panorama test and no MCMs were noted.  On 21-Nov-2019, the subject underwent second trimester screen and maternal serum alpha fetoprotein screening (MSAFP/serum markers). No MCMs were noted.  On 25-Nov-2019, the subject underwent anatomy ultrasound and no MCMs were noted.  On 12-Dec-2019, at unknown weeks of gestation, the subject was administered Flucelvax QIV (Flu Vaccine Cell Subunit QIV NVD) [influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 mL, batch number: 261228, route of administration, anatomical location and expiration date: not reported] (explicitly coded as 'Vaccine exposure during pregnancy') for an influenza immunisation.   On 24-Feb-2020, approximately two months after vaccination, the subject experienced pelvic pain, nausea, vomiting and developed viral syndrome. The subject started treatment with rectal promethazine suppository at the dose of 25 mg, administered every 6 to 8 hours, as needed and oral ondansetron at the dose of 8 mg, administered every 8 hours, both used for nausea and vomiting.  On 12-Mar-2020, approximately three months after vaccination, the subject was Group B Streptococcus positive.  On 19-Mar-2020, the subject underwent follow up growth ultrasound and no MCMs were noted.  At approximately 40.3 weeks of gestation (as reported), the subject vaginally delivered live male neonate. The neonate's birth weight was 3289 g, while head circumference and length were not reported. The appearance, pulse, grimace, activity, and respiration (APGAR) scores were 8 at one minute and 9 at five minutes. No data was provided for APGAR score at 10 minutes. No MCMs were identified at the time of birth.   At the time of initial reporting, the subject had not recovered from the events of bacterial infection due to streptococcus, group B', nausea, vomiting and pelvic pain, while the outcome for the event of viral syndrome was not reported.  The event of bacterial infection due to streptococcus, group B' was considered as serious due to criterion of medical significance, per company.  The reporter did not provide causality assessment.  Company comment: A pregnant subject was administered Flucelvax QIV. The subject experienced pelvic pain, nausea, vomiting and viral syndrome approximately two months after vaccination. The subject also developed Beta haemolytic streptococcal infection, three months after vaccination. Causality is assessed as not related for pelvic pain, nausea and vomiting due to pregnancy state and implausible chronology. Beta haemolytic streptococcal infection is not related to the suspect vaccine due to biological/pharmacological implausibility. Regarding the event of viral syndrome cannot be totally excluded, causality is unassessable with available information. Vaccine exposure during pregnancy assessed as not related per company's conventions.; Sender's Comments: A pregnant subject was administered Flucelvax QIV. The subject experienced pelvic pain, nausea, vomiting and viral syndrome approximately two months after vaccination. The subject also developed Beta haemolytic streptococcal infection, three months after vaccination. Causality is assessed as not related for pelvic pain, nausea and vomiting due to pregnancy state and implausible chronology. Beta haemolytic streptococcal infection is not related to the suspect vaccine due to biological/pharmacological implausibility. Regarding the event of viral syndrome cannot be totally excluded, causality is unassessable with available information. Vaccine exposure during pregnancy assessed as not related per company's conventions.