Age: 27.0
Sex: F
Vaccine: FLUX
Symptoms: Anaemia, Caesarean section, Exposure during pregnancy, Gardnerella infection, Prenatal screening test
Clinical narrative: Anemia; Gardnerella; Vaccine exposure during pregnancy; This is an observational study case, initially received from other health professional on 03-Apr-2020, concerning a 27-year-old, female pregnant subject of body weight: 354 lbs, height: 71 inches and body mass index (BMI): 49.4 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) for pregnancy and Metorgel for an unknown indication.  The subject's obstetrical history noted that subject had four previous pregnancies with two full term live births and two spontaneous abortions. The subject had no history of offspring with major congenital malformation (MCM). The subject had no relevant maternal and paternal medical history. The subject did not use tobacco or alcohol during pregnancy, but the subject was marijuana user.  The subject's last menstrual period (LMP) date was reported as 17-Jun-2019. The subject's estimated delivery date (EDD) and corrected estimated date of delivery (CEDD) ware reported as 24-Mar-2020. The type of pregnancy was singleton.   On 15-Oct-2019, the subject underwent spinal muscular atrophy and cystic fibrosis mutation analysis and no MCM was noted.  On 22-Oct-2019, approximately at gestational age of 18 weeks (calculated per LMP), the subject was administered with Flucelvax QIV (Flu Vaccine Cell Subunit QIV NVD) [influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, batch number: 261218, route of administration, anatomical location and expiration date: not reported] (explicitly coded as Vaccine exposure during pregnancy') for influenza immunisation.   On 31-Oct-2019, 9 days after vaccination, the subject developed Gardnerella infection.  On 10-Nov-2019, the outcome of the event Gardnerella infection was resolved.  On 11-Nov-2019, the subject underwent ultrasound and no MCM was noted.  On 11-Dec-2019, the subject underwent panorama and no MCM was noted.  On 08-Jan-2020 and 20-Feb-2020, the subject underwent ultrasound and no MCM was noted.  On 03-Mar-2020, 4 months 10 days after vaccination, the subject experienced anaemia. The subject was treated with ferrous sulfate 325 mg, twice a day, orally, from 03-Mar-2020 to 17-Mar-2020.  On 17-Mar-2020, at gestational age of 39.1 weeks (as reported), the subject delivered live birth male neonate by caesarean method. The neonate's birth weight was 3915 g, head circumference was 34.9 cm and length was 52.1 cm. The appearance, pulse, grimace, activity, and respiration (APGAR) scores at one minute and at five minutes were 8 and at ten minutes was not provided. No pregnancy complications were reported and no MCM was identified at birth.   On the same day, the outcome of the event anaemia was resolved.  The event of Gardnerella infection was assessed as serious due to the criterion of medical significance, per company.  The reporter did not provide causality assessment.  Company comment: A 27-year-old female pregnant subject developed Gardnerella infection and anaemia after vaccination with the suspect product Flucelvax QIV for an influenza immunisation. Reportedly, 9 days after vaccination, the subject developed Gardnerella infection and anaemia was noted 4 months 10 days after vaccination. Chronology seems plausible for both events. The subject's obstetrical history noted that subject had four previous pregnancies with two full term live births and two spontaneous abortions. The subject had no history of offspring with major congenital malformation (MCM). The subject's medical history included obesity. The subject's concomitant medications included Prenatal vitamins (unspecified vitamins and minerals) for pregnancy and Metorgel for an unknown indication. With information presented, causality is assessed as not related for Gardnerella infection and unlikely related for anaemia due to reported pregnancy which seems as a more likely confounder for this event. Gardnerella is very commonly experienced during pregnancy as well as in the weeks following the birth of the baby. Exposure during pregnancy is assessed as unrelated per company conventions. (''unlikely related'' defaults to "related" in the safety database for reporting purposes); Sender's Comments: A 27-year-old female pregnant subject developed Gardnerella infection and anaemia after vaccination with the suspect product Flucelvax QIV for an influenza immunisation. Reportedly, 9 days after vaccination, the subject developed Gardnerella infection and anaemia was noted 4 months 10 days after vaccination. Chronology seems plausible for both events. The subject's obstetrical history noted that subject had four previous pregnancies with two full term live births and two spontaneous abortions. The subject had no history of offspring with major congenital malformation (MCM). The subject's medical history included obesity. The subject's concomitant medications included Prenatal vitamins (unspecified vitamins and minerals) for pregnancy and Metorgel for an unknown indication. With information presented, causality is assessed as not related for Gardnerella infection and unlikely related for anaemia due to reported pregnancy which seems as a more likely confounder for this event. Gardnerella is very commonly experienced during pregnancy as well as in the weeks following the birth of the baby. Exposure during pregnancy is assessed as unrelated per company conventions. (''unlikely related'' defaults to "related" in the safety database for reporting purposes)