Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Exposure during pregnancy, Papilloma viral infection, Ultrasound antenatal screen normal
Clinical narrative: HPV with CIN 1; HPV with CIN 1; Group B Streptococcus carrier; Vaccine exposure during pregnancy; This is an observational study case, received from other health professional on 21-Oct-2020 and concerned a 33-year-old, pregnant female subject of body weight: 178 lbs, height: 67 inches and body mass index (BMI): 27.9, enrolled a prospective observational safety study.  The subject's concurrent condition included body mass index increased. The patient's past medical history included urinary tract Infection with group B Streptococcus. The subject's concomitant medication included Prenatal DHA Vitamin for pregnancy, Flintstones (unspecified vitamins) for pregnancy and amoxicillin for urinary tract infection with group B Streptococcus.  The subject's obstetrical history included five previous pregnancies with two full term live births, two spontaneous abortions and one preterm live birth. The subject had no history of offspring with major congenital malformation (MCM). The subject had no maternal or paternal history with MCM. The subject did not use tobacco, alcohol or illicit drugs during pregnancy.   The subject's last menstrual period (LMP) date was 25-Jun-2020, estimated delivery date (EDD) was reported as 01-Apr-2021 and corrected estimated date of delivery (CEDD) was reported as 02-Apr-2021. The type of pregnancy was singleton.   On 11-Sep-2020, at gestational age of 11 weeks (calculated per LMP), the subject was vaccinated with Afluria QIV (Flu Vaccine Egg Split QIV CSL) (influenza vaccine; dose, route of administration and  anatomical location: not reported) (explicitly coded as 'Vaccine exposure during pregnancy') for influenza immunisation. The batch number reported was P100230203.   On the same day, ultrasound, Counsyl fundamental panel with fragile X and Counsyl chromosomes 13, 18, 21 and sex chromosome analysis revealed no MCMs.  On the same day, after receiving Afluria QIV, it was determined that the subject was group B Streptococcus carrier.  On 28-Sep-2020, 17 days after receiving Afluria QIV, the patient developed human papilloma virus infection (HPV) with Cervical intraepithelial neoplasia I (CIN 1)  At the time of initial reporting on 21-Oct-2020, the patient had not recovered from the events 'cervical intraepithelial neoplasia I', 'human papilloma virus infection' and 'bacterial infection due to streptococcus, group B'.   The reporter did not provide a causality assessment to Afluria QIV.  The events 'cervical intraepithelial neoplasia I', 'human papilloma virus infection' and 'bacterial infection due to streptococcus, group B' were considered to be medically significant by a Physician within Seqirus's Pharmacovigilance and Risk Management Department.  Company comment: Cervical dysplasia, papilloma viral infection and beta haemolytic streptococcal infection were associated with the use of the suspect product - Afluria QIV. Bacterial infection was detected the same day after vaccination (chronology suggestive) and other two 17 days after (chronology plausible). Causality is assessed as unrelated for streptococcal infection (due to biological implausibility) and also unrelated for other two events. Presence of papilloma infection may be the cause of cervical dysplasia and human papillomavirus is a common sexually transmitted infection (STI). Exposure during pregnancy  is assessed as unrelated per company conventions.; Sender's Comments: Cervical dysplasia, papilloma viral infection and beta haemolytic streptococcal infection were associated with the use of the suspect product - Afluria QIV. Bacterial infection was detected the same day after vaccination (chronology suggestive) and other two 17 days after (chronology plausible). Causality is assessed as unrelated for streptococcal infection (due to biological implausibility) and also unrelated for other two events. Presence of papilloma infection may be the cause of cervical dysplasia and human papillomavirus is a common sexually transmitted infection (STI). Exposure during pregnancy  is assessed as unrelated per company conventions.