Age: 21.0
Sex: F
Vaccine: FLUC4
Symptoms: Alpha 1 foetoprotein normal, Anaemia, Bacterial vaginosis, Delivery, Exposure during pregnancy
Clinical narrative: Anaemia in pregnancy; Bacterial vaginosis; Urinary tract infection; Vaccine exposure during pregnancy; This is an observational study case, initially received from other health professional on 15-Jul-2020, concerning a 21-year-old, female pregnant subject of body weight: 96.2 lbs, height: 61.2 inches and body mass index (BMI): 18.1, enrolled in, a prospective observational safety study on pregnancy outcomes in woman immunized with seasonal cell culture influenza trivalent (TIVc) or quadrivalent (QIVc) vaccine during pregnancy.  The subject's medical history included urinary tract infection, body mass index low and morning sickness.  The subject's concomitant medications included Diclegis (doxylamine succinate, pyridoxine hydrochloride) for morning sickness, Macrobid (nitrofurantoin) for urinary tract infection, Tdap (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid) as vaccine.  The subject's had no obstetrical history. The subject had no history of offspring with major congenital malformation (MCM). The subject had no maternal history with MCM, while paternali medical history included hematochromatosis of grand grandmother. Also, the father of the baby was a carrier of hematochromatosis. The subject did not use tobacco or alcohol during pregnancy. The subject used cannabis during pregnancy.  The subject's last menstrual period (LMP) date was reported as 17-Jul-2019. The type of pregnancy was singleton. The subject's estimated delivery date (EDD) and corrected estimated date of delivery (CEDD) both were reported as 16-Apr-2020.   On 30-Sep-2019, at approximately 10 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: 261200, dose: 0.5 mL, route of administration, anatomical location and expiration date: not reported] (explicitly coded as 'Vaccine exposure during pregnancy') for influenza immunisation.   On 07-Oct-2019, the subject underwent frst trimester screen and nuchal translucency, no MCM was noted.  On 04-Nov-2019, the subject underwent maternal serum alpha-fetoprotein (MSAFP/serum markers) test and second trimester screen, no MCM was noted.  On 03-Dec-2019, the subject underwent anatomy ultrasound, no MCM was noted.  On 31-Dec-2019, three months and one day after vaccination, the subject developed urinary tract infection (UTI) and started treatment with cefpodoxime, one tablet every 12 hours (q12hrs), oral.  On 07-Jan-2020, the treatment with cefpodoxime was stoped.  On the same day, three months and eight day after vaccination, the subject developed bacterial vaginosis and started treatment with Metrogel (metronidazole), one applicator every day (qd), vaginal.  On 12-Jan-2020, the treatment with Metrogel was stoped.  On 22-Jan-2020, three months and 23 day after vaccination, the subject developed anaemia in pregnancy and started treatment with Ferralet (ferrous gluconate), one tablet every day (qd), oral.  At gestational age of 40.7 weeks (as reported), the subject vaginally delivered live birth, female neonate. The neonate's birth weight was 3402 grams, length and head circumference were not reported. The appearance, pulse, grimace, activity, and respiration (APGAR) score was at one minute: 8, at five minutes: 9 and at ten minutes: not reported. No MCM was identified at birth.  The outcome of the event UTI was resolved, on 07-Jan-2020.  The outcome of the event bacterial vaginosis was resolved, on 12-Jan-2020.  At the time of this report, the outcome of the event 'anaemia' was not resolved.  The events of urinary tract infection was assessed as serious due to criterion of medical significance per the company.  The reporter did not provide causality assessment to Flucelvax QIVc.  Company comment: A 21-year-old pregnant subject experienced urinary tract infection (UTI), bacterial vaginosis and anaemia of pregnancy three months after administration of Flucelvax QIVc. Chronology is unssugestive. UTIs are common during pregnancy, because growing uterus makes pressure on the bladder and urinary tract. Moreover, the subject's medical history included urinary tract infection. Causality was highly confounded for anaemia and bacterial vaginosis as well, by pregnancy state. Causal role of the suspect vaccine is assessed as not related for all events. Vaccine exposure during pregnancy was assessed as unrelated per company's conventions.; Sender's Comments: A 21-year-old pregnant subject experienced urinary tract infection (UTI), bacterial vaginosis and anaemia of pregnancy three months after administration of Flucelvax QIVc. Chronology is unssugestive. UTIs are common during pregnancy, because growing uterus makes pressure on the bladder and urinary tract. Moreover, the subject's medical history included urinary tract infection. Causality was highly confounded for anaemia and bacterial vaginosis as well, by pregnancy state. Causal role of the suspect vaccine is assessed as not related for all events. Vaccine exposure during pregnancy was assessed as unrelated per company's conventions.