Age: 28.0
Sex: F
Vaccine: FLUX
Symptoms: Vulvovaginal pruritus
Clinical narrative: Urinary tract infection; Anemia; Leg muscle spasm/cramps; Vulva itching; Vaccine exposure during pregnancy; This observational study case from was received on 01-Dec-2020 from other health professional, concerning a 28-year-old female, pregnant subject (Race: Asian, Ethnicity: Not Hispanic or Latino) (subject ID: 002-0459) of body weight: 95 lbs, height: 61 inches and body mass index (BMI): 17.9, enrolled in CSLCT-OBS-17-15, a prospective observational study on pregnancy outcomes in women immunized with Afluria QIV, a seasonal quadrivalent vaccine, during pregnancy.  The subject's concurrent conditions included low BMI. The subject's concomitant medication included Vitafol one (ascorbic acid, betacarotene, colecalciferol, cupric oxide, cyanocobalamin, folic acid, magnesium oxide, nicotinamide, omega-3 fatty acids, polysaccharide-iron complex, potassium iodide, pyridoxine hydrochloride, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide) for healthy pregnancy.  The subject's obstetrical history included two previous pregnancies, one full term live birth and one elective abortion. The subject had no history of offspring with major congenital malformations (MCMs) and no relevant maternal or paternal medical history with MCM. The subject did not use tobacco, alcohol or illicit drugs during pregnancy.  The subject's last menstrual period (LMP) date was 21-Jul-2020. The type of pregnancy was singleton. The estimated delivery date (EDD) was reported as 27-Apr-2021 and corrected estimated date of delivery (CEDD) was not reported.   On 05-Sep-2020, at gestational age of six weeks (calculated per LMP), the subject was vaccinated with Afluria QIV (Flu Vaccine Egg Split QIV CSL) (influenza vaccine; dose, route of administration, anatomical location: not reported) (explicitly coded as 'Vaccine exposure during pregnancy') for an influenza immunisation. The batch number reported was P100239705.  On 19-Oct-2020, one month and 14 days after receiving Afluria QIV, the subject developed vulva itching and started treatment with 0.1 % nystatin and triamcinolone, topically, twice a day.  On 24-Oct-2020, the subject recovered from the event of 'vulval itching'.  On 26-Oct-2020, first trimester screen revealed no MCMs.   On 02-Nov-2020, the treatment with 0.1 % nystatin and triamcinolone was stopped.  On 30-Nov-2020, the subject developed leg muscle spasm/cramps and started treatment with 600 mg of Caltrate 600-D (calcium carbonate, colecalciferol), orally, twice a day. On the same day, second trimester sequential screen revealed no MCMs.  On 28-Dec-2020, the subject recovered from the event of 'leg spasm'.  On an unspecified date, an unknown amount of time after receiving Afluria QIV, the subject developed urinary tract infection (UTI) and anemia.  On 04-Jan-2021, the subject started treatment with 100 mg of Macrobid (nitrofurantoin), orally, twice a day for UTI.  On 24-Feb-2021, the subject started treatment with 325 mg of ferrous sulfate, orally, twice a day for anaemia.  The outcome of the events urinary tract infection and anaemia was not reported.  The reporter did not provide a causality assessment.  The event of 'urinary tract infection' was considered to be medically significant by a Physician.  Additional information received on 10-Dec-2020 from other health professional and processed together with significant case correction performed on 17-Dec-2020: Correction made to information received on 01-Dec-2020: Stop date was provided for treatment with nystatin and triamcinolone. The narrative was amended accordingly. Company comment amended per correction request.   Additional information received on 08-Jan-2021 from other health professional: The start and stop dates for the events of 'leg spasm' and 'vulval itching' were provided while the outcome changed from 'not reported' to 'resolved'. The narrative was amended accordingly.  Additional information received on 16-Mar-2021 from other health professional: The events of urinary tract infection and anemia were added and the case was upgraded from non-serious to serious. Second trimester sequential screen added. Macrobid and ferrous sulfate added as treatment medications. The narrative was amended accordingly.  Company comment: A 28-year-old, pregnant subject was vaccinated with Afluria QIV at gestational age of six weeks. The subject developed vulva itching 1 month 14 days post vaccination and muscle spasm/cramps 2 months 25 days post vaccination. On an unspecified date, an unknown amount of time after receiving Afluria QIV, the subject developed urinary tract infection (UTI) and anaemia. Causality is not related for all events, due to biological implausibility (for UTI), chronological implausibility (muscle spasm and vulva itching) and alternative aetiology (iron-deficiency aetiology and pregnancy state). Vaccine exposure during pregnancy is assessed as not related per company's conventions.; Sender's Comments: A 28-year-old, pregnant subject was vaccinated with Afluria QIV at gestational age of six weeks. The subject developed vulva itching 1 month 14 days post vaccination and muscle spasm/cramps 2 months 25 days post vaccination. On an unspecified date, an unknown amount of time after receiving Afluria QIV, the subject developed urinary tract infection (UTI) and anaemia. Causality is not related for all events, due to biological implausibility (for UTI), chronological implausibility (muscle spasm and vulva itching) and alternative aetiology (iron-deficiency aetiology and pregnancy state). Vaccine exposure during pregnancy is assessed as not related per company's conventions.