Age: 21.0
Sex: F
Vaccine: UNK
Symptoms: Exposure during pregnancy, Fungal infection, Vulvovaginal pruritus
Clinical narrative: Arrest of dilation; Failure to descend; Yeast / vaginal itching; Vaccine exposure during pregnancy; This is an observational pregnancy study case, initially received from other health professional on 12-Dec-2019, concerning a 21-year-old, adult, female pregnant subject of body weight: 160 lbs, height: 61.2 inches and body mass index (BMI): 30, enrolled in a prospective observational study.  The subject's current medical conditions included obesity (BMI 30) and iron deficiency.   The subject's concomitant medications included Fusion Plus (ascorbic acid, biotin, cyanocobalamin, ferrous fumarate, folic acid, lactobacillus casei, nicotinic acid, pantothenic acid, polysaccharide-iron complex, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride) for iron deficiency and Prenatal vitamins (minerals nos, vitamins nos) for OB (obstetrical) supplement.   The subject's obstetrical history included no previous pregnancies. The subject did not have a history of offspring with major congenital malformation (MCM).  Also, the subject had no maternal or paternal history with major congenital malformations.   The subject's last menstrual period (LMP) date was 20-Feb-2019, estimated delivery date (EDD) and corrected estimated date of delivery (CEDD) were reported as 27-Nov-2020. The subject did not use tobacco, alcohol or illicit drugs during pregnancy.   On an unknown date, the pregnancy status was collected, and no pregnancy complications were noted. The type of pregnancy was singleton.  On 17-May-2019, the subject underwent first trimester screen and nuchal translucency and no MCM was noted.   On 19-May-2019, the subject underwent second trimester screen and MSFAP (maternal serum alpha-fetoproteins) / serum markers and no major congenital malformation was noted.   On 09-Jul-2019, the subject underwent anatomy ultrasound and no major congenital malformation was noted.   On 20-Sep-2019, at 30 weeks of gestation, the subject was administered Flucelvax QIVc (influenza vaccine, subunit influenza virus vaccine polyvalent; batch number: 261200, dose: 0.5 ml, route of administration, expiry date and anatomical location: not reported] for influenza immunisation (explicitly coded as Vaccine exposure during pregnancy').  On 24-Sep-2019, four days after vaccination, the subject developed yeast/vaginal itching. The subject was treated with metronidazole (1 applicator, every day, administered vaginally, start date: 24-Sep-2019, stop date: 29-Sep-2019) and fluconazole (1 tablet, every day, administered orally, start date: 24-Sep-2019, stop date: 25-Sep-2019).   On 29-Sep-2019, the subject recovered from yeast/vaginal itching.   At 39.5 weeks of gestation, the subject gave a live birth to a normal male neonate, by caesarean delivery (per reporter delivery was complicated by failure to descend, oligohydramnios, arrest of dilation). The neonate's birth weight was 3402 grams, head circumference and body length were not reported. The appearance, pulse, grimace, activity and respiration (APGAR) scores were 9 (at one minute) and 9 (at five minutes). APGAR score was not reported for 10 minutes. There was no major congenital malformation identified at birth.   At the time of initial report, outcomes of the events cervix dystocia' and arrested labor' were not reported.   The event of cervix dystocia' and arrested labor' were considered as serious, due to the criterion of medical significance, per company.   The reporter did not provide causality assessment.   This case is linked to 201907307 (corresponding baby case).  Company comment: The patient developed vulvovaginal mycotic infection, 4 days after vaccination with Flu Vaccine Cell Subunit QIV NVD. Vaccine was administered at 30 weeks of gestation, which was coded as vaccine exposure during pregnancy. Chronology is plausible. Reportedly, delivery was complicated by cervix dystocia and arrested labour. Causal role of the suspect vaccine cannot be excluded and is assessed as related for the events of vulvovaginal mycotic infection, cervix dystocia and arrested labour. Vaccine exposure during pregnancy is assessed as unrelated per company's conventions.; Sender's Comments: The patient developed vulvovaginal mycotic infection, 4 days after vaccination with Flu Vaccine Cell Subunit QIV NVD. Vaccine was administered at 30 weeks of gestation, which was coded as vaccine exposure during pregnancy. Chronology is plausible. Reportedly, delivery was complicated by cervix dystocia and arrested labour. Causal role of the suspect vaccine cannot be excluded and is assessed as related for the events of vulvovaginal mycotic infection, cervix dystocia and arrested labour. Vaccine exposure during pregnancy is assessed as unrelated per company's conventions.