Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, Placenta praevia, Ultrasound antenatal screen normal
Clinical narrative: Low lying placenta; Vaccine exposure during pregnancy; This is an observational study case, initially received on 01-Nov-2019, concerning a 36-year-old pregnant, female subject of body weight 147.5 lbs, height 63 inches and body mass index (BMI) 26.1 enrolled in, a prospective observational safety study. The subject's partner age was 37.  The subject's obstetrical history noted that the subject had one previous full-term, live birth pregnancy with no birth defects. 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 did not use tobacco, alcohol or illicit drugs during pregnancy.   The subject's last menstrual period (LMP) date was 23-Apr-2019. The subject's estimated date of delivery (EDD) and corrected estimated date of delivery (CEDD) were reported as 28-Jan-2020. The type of pregnancy was singleton.   The subject's current medical conditions included hematochezia, interstitial cystitis, nausea, vitamin D deficiency and high body mass index. The subject's risk factor included advanced maternal age at 36 years. Concomitant medications included Uribel (hyoscyamine, methenamine, methylthioninium, phenyl salicylate, and phosphoric acid) for interstitial cystitis, cholecalciferol for vitamin D deficiency, Bonjesta (doxylamine succinate, pyridoxine hydrochloride) for nausea and Prenate Mini (folic acid, iron, minerals NOS and vitamins NOS) as prenatals.  On 03-Sep-2019, the subject underwent ultrasound and no MCM was noted.  On 30-Sep-2019, the subject underwent ultrasound and no MCM was noted.  On 24-Oct-2018, at approximately 26 weeks of gestation, the subject was administered Afluria QIV [influenza vaccine, subunit influenza virus vaccine polyvalent, cell cultured derived, batch number: P100126099, dose, route of administration, anatomical location and expiration date: not reported] (explicitly coded as ''Vaccine exposure during pregnancy'') for an influenza immunisation.   On the same day, the subject underwent ultrasound and no MCM was noted.  On an unknown date, the subject's pregnancy status was collected, and it was noted that the subject had a low-lying placenta as a pregnancy complication. No further details were provided.  At the time of initial reporting, the outcome of the event was not reported.   The case was assessed as serious.   The reporter did not provide causality assessment to Afluria Quadrivalent.  Company comment: Placenta praevia was diagnosed on an unknown date after vaccination with Afluria. Based on the available information causal involvement of Afluria is unlikely, however cannot be excluded, therefore this event is assessed as related to the suspect vaccine. Exposure during pregnancy is unrelated to the product per company's conventions.; Sender's Comments: Placenta praevia was diagnosed on an unknown date after vaccination with Afluria. Based on the available information causal involvement of Afluria is unlikely, however cannot be excluded, therefore this event is assessed as related to the suspect vaccine. Exposure during pregnancy is unrelated to the product per company's conventions.