Age: 28.0
Sex: F
Vaccine: FLUX
Symptoms: Streptococcus test negative, Vulvovaginal pruritus
Clinical narrative: Delivery at 36.1 weeks of gestational age; Vulvar itching; Vaccine exposure during pregnancy; This is an observational study case from, initially received from other health professional on 02-Apr-2020, concerning a 28-year-old, pregnant, female subject of body weight: 132 lbs, height: 65 inches and body mass index (BMI): 22, enrolled in, a prospective observational safety study.  The subject's medical history was not reported.  The subject's concomitant medications included OB Complete (fish oil, doconexent, icosapent, calcium ascorbate, cholecalciferol, alpha-tocopherol acetate, d-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, biotin, calcium threonate, calcium malate, calcium carbonate, iron, ferrous asparto glycinate, potassium iodide, magnesium oxide, zinc oxide, and cupric sulfate) for healthy pregnancy.   The subject's obstetrical history included one previous pregnancy with one spontaneous abortion. The subject had no history of offspring with major congenital malformation (MCM) and no relevant maternal and 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 14-Jul-2019. The type of pregnancy was singleton. The subject's estimated delivery date (EDD) was reported as 19-Apr-2020 and corrected estimated date of delivery (CEDD) was not reported.   On 21-Sep-2019, at approximately nine weeks of gestation (calculated per LMP), the subject was administered Afluria QIV (Flu Vaccine Egg Split QIV CSL) [influenza vaccine, batch number: P100110950, dose, route of administration, anatomical location and expiration date: not reported] (explicitly coded as 'Vaccine exposure during pregnancy') for an influenza immunization.  On 05-Oct-2019, the subject underwent first trimester screen and cystic fibrosis mutation analysis and no MCM was noted.  On 02-Nov-2019, the subject underwent second trimester screen and no MCM was noted.  On 04-Jan-2020, the subject underwent one-hour glucose test and no MCM was noted.  On 01-Feb-2020, four months and 11 days after vaccination, the subject experienced vulvar itching and started treatment for vulvar itching with Lotrisone cream (betamethasone dipropionate, clotrimazole), at dose of 0.05 percent, topically to affected area, twice a day.   On 15-Feb-2020, the patient recovered from the event of vulval icthing and treatment with Lotrisone cream was completed.   On 14-Mar-2020, the subject underwent group B strep test and no MCM was noted.  On 23-Mar-2020, at approximately 36.1 weeks of gestation (as reported), the subject vaginally delivered live, male neonate. The neonate's birth weight was 2339 g, while the head circumference: 30.5 cm and body length: 45.1 cm. The appearance, pulse, grimace, activity, and respiration (APGAR) scores were 9 at one and at five minutes and for ten minutes was not reported. No MCMs were identified at the time of birth.   At the time of this follow up, the outcome of the event premature delivery' was not reported.  The event of premature delivery' was assessed as serious, due to criterion of medical significance.  The reporter did not provide causality assessment.  The case is linked to the case 202003469 (the corresponding baby's case).  Follow up information received from other health professional on 23-Apr-2020: Start and stop dates for the event of vulval icthing provided and outcome updated to resolved. Narrative updated accordingly.  Follow up received from other health professional on 18-May-2020: Pregnancy outcome was received and pregnancy information were added.  The event of 'premature delivery' was added as new event and case was upgraded from non-serious to serious. Stop date added for the event 'vaccine exposure during pregnancy' and the outcome was changed from not reported to resolved. The narrative was amended accordingly.  Company comment: A pregnant subject experienced vulvovaginal pruritus, 4 months and 11 days after receiving Afluria QIV and premature delivery 6 months 2 days after vaccination. Chronology is unsuggestive. Causal role of the suspect vaccine is assessed as not related for both events. Vaccine exposure during pregnancy assessed as not related per company's conventions.; Sender's Comments: A pregnant subject experienced vulvovaginal pruritus, 4 months and 11 days after receiving Afluria QIV and premature delivery 6 months 2 days after vaccination. Chronology is unsuggestive. Causal role of the suspect vaccine is assessed as not related for both events. Vaccine exposure during pregnancy assessed as not related per company's conventions.