Age: 34.0
Sex: F
Vaccine: FLUX
Symptoms: Ultrasound antenatal screen normal, Urinary tract infection
Clinical narrative: Urinary tract infection (UTI); Vaccine exposure during pregnancy; This is an observational study case, reported by other health professional and initially received on 15-Jul-2020, concerning a 34-year-old pregnant, female subject, of body weight 144 lbs, height 66 inches and body mass index (BMI) 23.2, enrolled in a prospective observational safety study.   The subject's current medical conditions included pregnancy with advanced maternal age and increased BMI.   The subject's concomitant medication included Prenatal vitamins (unspecified vitamins and minerals) as vitamin supplementation and TDAP (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid) as vaccine immunization.  The subject's obstetrical history noted that the subject had five previous pregnancies which included three previous full-term live births and two spontaneous abortions. The subject had no history of offspring with major congenital malformation (MCM). Also, the subject had no maternal or paternal history with MCM. The father of baby had Wolff-Parkinson-White syndrome. The subject did not use tobacco, alcohol or illicit drugs during pregnancy.   The subject's last menstrual period (LMP) date was 10-Aug-2019. The subject's estimated delivery date (EDD) and corrected estimated date of delivery (CEDD) were reported as 16-May-2020. The type of pregnancy was singleton.  On 30-Oct-2019, at approximately 11 weeks of gestation (calculated by LMP), 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: 261727, route of administration, anatomical location and expiration date: not reported] (explicitly coded as ''Vaccine exposure during pregnancy'') for an influenza immunisation.   On the same day, the subject underwent Maternit 21 test and no MCM was noted.  On 04-Dec-2019, the subject underwent maternal serum alfa fetoprotein screening (MSAFP / serum markers) and second trimester screen. No MCM was noted.  On 23-Dec-2019, the subject underwent anatomy ultrasound. No MCM was noted.  On 07-Feb-2020, three months and eight days after vaccination, the subject developed urinary tract infection (UTI) and started treatment with oral cefpodoxime at dose of 1 tablet, every 12 hours.  On 14-Feb-2020, the subject stopped with cefpodoxime treatment and recovered from urinary tract infection.  On 06-May-2020, the subject underwent ultrasound growth. No MCM was noted.  At gestational age of 39.9 weeks (as reported), the subject vaginally delivered a live birth, male neonate. The neonate's birth weight was 3997 grams, while head circumference and body length were not reported. Appearance, pulse, grimace, activity, and respiration (APGAR) scores were 8 (one minute) and 9 (five minutes). No data for APGAR score at 10 minutes was provided. No MCM was identified at birth.  The event of urinary tract infection was considered serious due criterion of medical significance, per company.  The reporter did not provide causality assessment to Flucelvax QIV.  Company comment: A 34-year-old pregnant subject was administered Flucelvax QIVc at gestational age of 11 weeks. The subject developed urinary tract infection (UTI) three months and eight days after vaccination. UTIs are frequent during pregnancy, because growing uterus makes pressure on the bladder and urinary tract. Due to unsuggestive temporal relationship, biological implausibility and mentioned confounder, 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 34-year-old pregnant subject was administered Flucelvax QIVc at gestational age of 11 weeks. The subject developed urinary tract infection (UTI) three months and eight days after vaccination. UTIs are frequent during pregnancy, because growing uterus makes pressure on the bladder and urinary tract. Due to unsuggestive temporal relationship, biological implausibility and mentioned confounder, causality between suspect product and the event is assessed as not related. Vaccine exposure during pregnancy is not related per company's conventions.