Age: 31.0
Sex: F
Vaccine: UNK
Symptoms: Chlamydia test positive, Chlamydial infection, Exposure during pregnancy
Clinical narrative: Chlamydia; Vaccine exposure during pregnancy; This is an observational study case, initially received from other health professional on 04-Nov-2019, concerning a 31-year-old, pregnant, female subject of body weight: 136 lbs, height: 63 inches and body mass index (BMI): 24.1 enrolled in a prospective observational safety study.  The subject's obstetrical history was collected and it was noted that the subject did not have any previous pregnancies, nor maternal and paternal history with major congenital malformation (MCM). The subject did not consume tobacco, alcohol and illicit-drugs during pregnancy.  The subject's medical history was not provided. The subject's concomitant medications included Prenatal vitamin (unspecified vitamins) for unknown indication.   The subject's last menstrual period (LMP) date was 23-May-2019, and estimated delivery date (EDD) was reported as 27-Feb-2020. The corrected estimated date of delivery was not reported. The type of pregnancy was singleton.  On 15-Aug-2019, the subject performed Sequential 1 and Nuchal translucency prenatal tests and no MCM was noted.  On 12-Sep-2019, the subject performed Sequential 2 and no MCM was noted.  On 10-Oct-2019, the subject underwent targeted ultrasound and bilateral choroid plexus cysts were noted.  On the same date, at gestational age of 20 weeks, the subject was administered Flu Vaccine Egg Split QIV CSL (Afluria QIV) [Influenza Vaccine, batch number: P100112488, dose, route of administration, anatomical location and expiry date: not reported) (explicitly coded as 'Vaccine exposure during pregnancy') for influenza immunisation.  On 05-Nov-2019, pregnancy status was collected, and it was noted that the subject was positive to chlamydia. No further details were reported.   At the time of initial reporting, the outcome of the event was not reported.   This case was assessed as serious (medically significant).   The reporter did not provide causality assessment.  This case is linked to 201905904, the corresponding child case.  Company comment: The subject experienced chlamydial infection after vaccination with the suspect product Afluria QIV. Reportedly, vaccination occurred during pregnancy at gestational age of 20 weeks. Chronology is plausible. Pregnant state may have contributed to development of the event. Vaccine exposure during pregnancy is assessed as not related per company's conventions. For the event chlamydial infection, causality between suspect product and the event cannot be totally excluded and is assessed as unlikely related.; Sender's Comments: The subject experienced chlamydial infection after vaccination with the suspect product Afluria QIV. Reportedly, vaccination occurred during pregnancy at gestational age of 20 weeks. Chronology is plausible. Pregnant state may have contributed to development of the event. Vaccine exposure during pregnancy is assessed as not related per company's conventions. For the event chlamydial infection, causality between suspect product and the event cannot be totally excluded and is assessed as unlikely related.