Age: 34.0
Sex: F
Vaccine: UNK
Symptoms: Anaemia, Chlamydial infection, Exposure during pregnancy, Polyhydramnios
Clinical narrative: Chlamydia; Anemia; Vaccine exposure during pregnancy; This is an observational study case, initially received from other health professional on 01-Apr-2020, concerning a 34-year-old pregnant, female subject of body weight 305 lbs, height 71 inches and body mass index (BMI) 42.5, enrolled in a prospective observational safety study.  The subject's historical condition included trichomoniasis. The subject's current condition included hyperthyroidism, chronic hypertension (CHTN), obesity (body mass index 42.5), nausea, vomiting, acid reflux and history of abruption.  The subject's concomitant medications included Prenatal vitamins (unspecified vitamins and minerals) for pregnancy, Pepcid (famotidine) for acid reflux and Zofran (ondansetron) for nausea and vomiting.  The subject had two previous pregnancies, one full time live birth and one preterm live birth. The subject had no history of offspring with major congenital malformation (MCM). Also, the subject had no maternal or paternal history with MCM. The subject used tobacco (decreased from 20 cigarettes to 10 daily) during pregnancy. The subject did not use alcohol or illicit drugs during pregnancy.   The subject's last menstrual period (LMP) date was 14-Jun-2019. The subject's estimated date of delivery (EDD) was 21-Mar-2020, while corrected estimated date of delivery (CEDD) was 17-Mar-2020. The type of pregnancy was singleton.   On 14-Avg-2019, the subject underwent ultrasound and no MCMs were noted.  On 06-Sep-2019, the subject underwent first sequential and nuchal translucency and no MCMs were noted.  On 03-Oct-2019, the subject underwent second sequential and no MCMs were noted.  On 31-Oct-2019, the subject underwent 20week anatomy ultrasound and no MCMs were noted.  On 27-Jan-2020, at approximately 32 weeks of pregnancy, the subject was administered Afluria QIV (Flu Vaccine Egg Split QIV CSL) [influenza vaccine, subunit influenza virus vaccine polyvalent, cell cultured derived; batch number: P100112488, dose, route of administration, anatomical location and expiration date: not reported] (explicitly coded as 'Vaccine exposure during pregnancy') for influenza immunisation.   On an unknown date, polyhydramnios was noted.   On 24-Feb-2020, 28 days after vaccination, the subject developed anaemia and started treatment with oral ferrous sulfate at dose of 325 mg, administered via oral route every day.  On 02-Mar-2020, 1 month 4 days after vaccination, the subject developed chlamydia.  On 09-Mar-2020, 1 month and 11 days after vaccination, the subject started treatment with oral azithromycin at dose of 2 gr, administered via oral route every day every day.  On 10-Mar-2020, the next day, the subject stopped treatment with azithromycin.  On the same day, the outcome of event chlamidia' was resolved.  At the time of this report the outcome of event anemia' was not resolved.  The event of 'chlamidia' was assessed as serious due to criterion of medical significance, per company.  The reporter did not provide causality assessment to Afluria QIV.  This case is linked to the case 202002692, the corresponding baby case.  Company comment: A pregnant subject experienced Chlamydial infection, 1 month and 4 days after receiving Afluria QIV. The subject also developed anaemia 28 days after vaccination. Chronology is plausible. The subject's historical condition included trichomoniasis. The subject's current condition included hyperthyroidism, chronic hypertension (CHTN), obesity (body mass index 42.5), nausea, vomiting, acid reflux and history of abruption. Anaemia is common during pregnancy. Causal role of the suspect vaccine cannot be excluded and is assessed as unlikely related to both events (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 4 days after receiving Afluria QIV. The subject also developed anaemia 28 days after vaccination. Chronology is plausible. The subject's historical condition included trichomoniasis. The subject's current condition included hyperthyroidism, chronic hypertension (CHTN), obesity (body mass index 42.5), nausea, vomiting, acid reflux and history of abruption. Anaemia is common during pregnancy. Causal role of the suspect vaccine cannot be excluded and is assessed as unlikely related to both events (defaults to "related" in the safety database for reporting purposes). Vaccine exposure during pregnancy assessed as not related per company's conventions.