Sex: F
Vaccine: UNK
Symptoms: Bacterial vaginosis, Delivery, Exposure during pregnancy, Fungal infection, Urogenital infection fungal
Clinical narrative: Bacterial vaginosis; Yeast; Vaccine exposure during pregnancy; This is an observational study case, initially received from other health professional on 06-Aug-2019, concerning a 25-year-old, adult female pregnant subject of body weight: 140 lbs, height: 67 inches and body mass index (BMI): 21.9 enrolled in a prospective observational safety study on pregnancy outcomes in women immunized with seasonal cell culture influenza trivalent (TIVc) or quadrivalent (QIVc) vaccine during pregnancy.  The subject had two previous pregnancies which included one live birth and one spontaneous abortion. The subject's family history of major congenital malformation was collected. The subject had no maternal/paternal history with major congenital malformations. The subject did not consume alcohol, tobacco and illicit-drug during pregnancy.   The subject's last menstrual period was 02-Sep-2018, estimated delivery date and corrected estimated date of delivery was 09-Jun-2019. The type of pregnancy was singleton.  The subject's concomitant medication included prenatal vitamins (vitamins not otherwise specified (nos) and mineral nos) for pregnancy.  On 23-Jan-2019, at  20 weeks of gestation, the subject was administered Flucelvax QIVc [influenza vaccine, subunit influenza virus vaccine polyvalent, batch number: 252664, dose: 0.5 ml, expiration date, route of administration and anatomical location: not reported] (explicitly coded as vaccine exposure during pregnancy) as influenza immunization.  On 20-Feb-2019, the subject experienced genitourinary yeast. The patient was treated with terconazole.  On 23-Feb-2019, the event of yeast was resolved.  On 26-Feb-2019, the subject developed bacterial vaginosis. The patient was treated with Metrogel 0.75% (metronidazole).   On 08-Mar-2019, the event of bacterial vaginosis was resolved.  On 19-May-2019, the subject vaginally delivered a full term male neonate at 37 weeks of the gestation. The neonate's birth weight was 3402 grams, head circumference and length were not reported. Appearance, pulse, grimace, activity and respiration (APGAR) score at one minute was 9, at five minutes was 9 and no data was reported for APGAR score at ten minutes. No major congenital malformation was identified at birth.  Company comment: The patient was diagnosed with urogenital infection fungal and bacterial vaginosis approximately one month after vaccination with Flu Vaccine Cell Subunit QIV NVD, administered at 20 weeks of gestation. Information regarding patient's medical history of previous genitourinary infectious was not provided. Pregnancy causes numerous changes in the woman's body that increase incidence of genitourinary infections, which provide more plausible explanation for development of the events. Therefore, the events of urogenital infection fungal and bacterial vaginosis were assessed as not related to the suspect vaccine. The event of exposure during pregnancy was assessed as not related considering the intended use of vaccine.; Reporter's Comments: The patient was diagnosed with urogenital infection fungal and bacterial vaginosis approximately one month after vaccination with Flu Vaccine Cell Subunit QIV NVD, administered at 20 weeks of gestation. Information regarding patient's medical history of previous genitourinary infectious was not provided. Pregnancy causes numerous changes in the woman's body that increase incidence of genitourinary infections, which provide more plausible explanation for development of the events. Therefore, the events of urogenital infection fungal and bacterial vaginosis were assessed as not related to the suspect vaccine. The event of exposure during pregnancy was assessed as not related considering the intended use of vaccine.