Age: 28.0
Sex: F
Vaccine: UNK
Symptoms: Exposure during pregnancy, Placenta praevia
Clinical narrative: Low lying placenta; Vaccine exposure during pregnancy; This is an observational study case, initially received from other health professional on 21-Oct-2019, concerning a 28-year-old, pregnant, female subject of body weight: 206 lbs, height: 65.3 inches and body mass index (BMI): 34, enrolled in a prospective observational study on pregnancy outcomes in women immunized with Afluria QIV, a seasonal quadrivalent vaccine, during pregnancy.  The subject's current conditions included genital herpes, hypertension, seasonal allergies and high body mass index (BMI 34). Concomitant medications included prenatal vitamins (minerals NOS, vitamins NOS) for pregnancy, nifedipine for hypertension, Allegra (fexofenadine hydrochloride) for allergies, vitamin B6 and vitamin D2 as supplements.  The subject's obstetrical history included four previous pregnancies with two full term live births, one spontaneous abortion and one elective abortion. No birth defects were reported. Also, the subject had no maternal or paternal history with major congenital malformations (MCMs). The subject did not use tobacco, alcohol or illicit drugs during pregnancy.  The subject's last menstrual period (LMP) date was 28-Apr-2019, the estimated delivery date (EDD) and corrected estimated date of delivery (CEDD) were reported as 02-Feb-2020. The type of pregnancy was singleton.   On 13-Jun-2019, 25-Jun-2019, 08-Jul-2019 and 03-Sep-2019, the subject underwent ultrasound scan and no MCM was noted.   On 01-Oct-2019, at gestational age of 22 weeks, the subject was administered Afluria (QIV) [influenza vaccine; batch number: P100118566, dose, route of administration, anatomical location and expiry date: not reported] (explicitly coded as 'Vaccine exposure during pregnancy') for an influenza immunisation.  On an unspecified date, an unknown amount of time after vaccination, low lying placenta was noted.   At the time of initial reporting, the outcome of the event 'low lying placenta was not reported.   The case was assessed as serious and the reporter did not provide a causality assessment.  Company comment: The subject experienced placenta praevia associated with the suspect product Afluria (QIV). Reportedly, vaccination occurred during pregnancy at gestational age of approximately 22 weeks of gestation. Temporal relationship is implausible because location of the placenta is determined at implantation (first 3 weeks of gestation). Causality was confounded by use of concomitant drugs, Allegra (fexofenadine hydrochloride) and nifedipine. Causal relationship between the suspect product and exposure during pregnancy is assessed as not related per company conventions. Causal relationship between the suspect product and the event placenta praevia is assessed as not related.; Sender's Comments: The subject experienced placenta praevia associated with the suspect product Afluria (QIV). Reportedly, vaccination occurred during pregnancy at gestational age of approximately 22 weeks of gestation. Temporal relationship is implausible because location of the placenta is determined at implantation (first 3 weeks of gestation). Causality was confounded by use of concomitant drugs, Allegra (fexofenadine hydrochloride) and nifedipine. Causal relationship between the suspect product and exposure during pregnancy is assessed as not related per company conventions. Causal relationship between the suspect product and the event placenta praevia is assessed as not related.