Sex: F
Vaccine: FLU4
Symptoms: Chlamydial infection, Exposure during pregnancy, Ultrasound antenatal screen normal
Clinical narrative: Chlamydia; Vaccine exposure during pregnancy; This is spontaneous case, initially received from other health professional on 01-Apr-2020, concerning a pregnant female patient of unknown age of body weight 97 lbs, height 63 inches and body mass index (BMI) 17.2. It was reported that the patient's age at conception was 17.  The patient's current medical history included teenage pregnancy and low BMI.  The patient's concomitant medication included Prenatal vitamin (unspecified vitamins and minerals) for pregnancy.  The patient's obstetrical history included that the patient had no previous pregnancies. The patient had no maternal or paternal history with major congenital malformation (MCM). The patient did not consume tobacco, alcohol or illicit drugs during pregnancy.   The patient's last menstrual period (LMP) date was 01-Sep-2019. The type of pregnancy was singleton. The patient's estimated delivery date (EDD) was 08-Jun-2020 and corrected estimated date of delivery (CEDD) was 11-Jun-2020.  On 07-Nov-2019, the patient underwent ultrasound and no MCM was noted.  On 04-Dec-2019, the patient underwent non-invasive prenatal testing (NIPT) and no MCM was noted.  On 03-Jan-2020, the patient underwent maternal serum alpha-fetoprotein (MSAFP/serum markers) test and no MCM was noted.  On 27-Jan-2020, at gestational age of 21 weeks (calculated per LMP), the patient was administered 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 an unknown indication. On the same day, the patient underwent anatomy ultrasound and no MCM was noted.  On 09-Mar-2020, 1 month and 11 days after vaccination, the patient developed chlamydia and started treatment for it with tablets of azithromycin at a dose of 2 g,administered  once a day via oral route of administration.  At the time of initial reporting, the outcome of chlamydial infection' was not resolved.  The event of chlamydial infection' was considered serious due to the criterion of medical significance.  The reporter did not provide a causality assessment to Afluria QIV.  Company comment: A pregnant subject experienced Chlamydial infection, 1 month and 11 days after receiving Afluria QIV. Chronology is compatible. The subject's current condition included teenage pregnancy and low BMI. Causal role of the suspect vaccine cannot be excluded and is assessed as unlikely related to the event (defaults to "related" in the safety database for reporting purposes). Vaccine exposure during pregnancy assessed as not related per company's conventions.; Sender's Comments: A pregnant subject experienced Chlamydial infection, 1 month and 11 days after receiving Afluria QIV. Chronology is compatible. The subject's current condition included teenage pregnancy and low BMI. Causal role of the suspect vaccine cannot be excluded and is assessed as unlikely related to the event (defaults to "related" in the safety database for reporting purposes). Vaccine exposure during pregnancy assessed as not related per company's conventions.