Age: 30.0
Sex: F
Vaccine: FLUX
Symptoms: Beta haemolytic streptococcal infection, Depression, Exposure during pregnancy, Streptococcus test positive
Clinical narrative: Group B strep positive; Depressive disorder; Vaccine exposure during pregnancy; This is an observational study case, initially received from other health professional on 11-Feb-2020, concerning a 30-year-old female pregnant subject of body weight 164 lbs, height 62 inches and body mass index (BMI) 30, enrolled in, a prospective observational safety study.  The subject's medical history included BMI increased.  The subject's concomitant medications included Citranatal B-calm (ascorbic acid, calcium citrate, colecalciferol, folic acid, iron pentacarbonyl, pyridoxine hydrochloride) as vitamin. It was reported that the subject had late entry prenatal care.  The subject's obstetrical history included three previous pregnancies with three previous full term live births. The subject had no maternal or paternal history with major congenital malformations (MCMs). The subject had no history of offspring with MCMs. The subject did not use tobacco, alcohol or illicit drugs during pregnancy.   The subject's last menstrual period date (LMP) was 28-Jun-2019 and type of pregnancy was singleton. The estimated delivery date (EDD) was 03-Apr-2020 and corrected estimated date of delivery (CEDD) was not reported. The type of pregnancy was singleton.  On 22-Oct-2019, at approximately 16 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: 261223, route of administration, anatomical location and expiration date: not reported] (explicitly coded as Vaccine exposure during pregnancy') for influenza immunization.   On an unspecified date, after vaccination, the subject developed depressive disorder and group B streptococcus positive.   At the time of this report, the outcome of the events depressive disorder and bacterial infection due to streptococcus group B was not resolved.  The event of bacterial infection due to streptococcus, group B was assessed as serious due to the criterion of medical significance.   The reporter did not provide causality assessment to Flucelvax QIV.  Company Comment: Flucelvax QIVc was administered at approximately 16 weeks of gestation. A subject experienced Beta haemolytic streptococcal infection and depression an unknown amount of time after vaccination. Chronology needs more clarification. Causal role of the suspect product cannot be totally excluded and is assessed as unlikely related for both events (defaults to "related" in the safety database for reporting purposes). Exposure during pregnancy is assessed as not related per company's conventions.; Sender's Comments: Flucelvax QIVc was administered at approximately 16 weeks of gestation. A subject experienced Beta haemolytic streptococcal infection and depression an unknown amount of time after vaccination. Chronology needs more clarification. Causal role of the suspect product cannot be totally excluded and is assessed as unlikely related for both events (defaults to "related" in the safety database for reporting purposes). Exposure during pregnancy is assessed as not related per company's conventions.