FDA Adverse Event Reporting System Quarterly Data Extract Files

Includes data files and supplemental information. Supplemental information includes a reproducible RMarkdown file, an Excel sheet with metadata, and complete webpage files.<br><br><br>From the FAERS Quarterly Data Extract Files Website:<br><br>The files listed on this page contain raw data extracted from the AERS database for the indicated time ranges and are not cumulative. Users of these files need to be familiar with creation of relational databases using applications such as ORACLE®, Microsoft Office Access, MySQL® and IBM DB2 or the use of ASCII files with SAS® analytic tools. A simple search of FAERS data cannot be performed with these files by persons who are not familiar with creation of relational databases. However, you can get a summary FAERS report for a product by sending a Freedom of Information Act (FOIA) request to FDA. You can also request individual case reports by submitting a FOIA request listing case report numbers. The quarterly data files, which are available in ASCII or SGML formats, include:demographic and administrative information and the initial report image ID number (if available);drug information from the case reports;reaction information from the reports;patient outcome information from the reports;information on the source of the reports;a "README" file containing a description of the files.Additional fields will appear in the 2014 Q3 date files below.<br>For more details: Summary of Changes for the 2014 Q3 Quarterly Date Extract (PDF -71 KB)

本数据集包含数据文件与补充材料。补充材料包含可复现的RMarkdown文件、带有元数据的Excel工作表，以及完整的网页文件。

FDA不良事件报告系统（FAERS）季度数据提取文件官网：

本页面列出的文件包含从指定时间范围内的不良事件报告系统（AERS，Adverse Event Reporting System）数据库中提取的原始数据，且不具备累积性。使用此类文件的用户需熟悉使用Oracle®、Microsoft Office Access、MySQL®及IBM DB2等应用程序构建关系型数据库的方法，或掌握借助SAS®分析工具处理ASCII文件的技能。不熟悉关系型数据库构建的用户无法通过此类文件直接检索FAERS数据。不过，用户可通过向美国食品药品监督管理局（FDA）提交信息自由法（FOIA，Freedom of Information Act）申请，获取某一产品的FAERS汇总报告；也可通过提交列明病例报告编号的FOIA申请，索要单个病例报告。

本季度数据文件支持ASCII或标准通用标记语言（SGML）格式，包含以下内容：病例报告中的人口统计学与管理信息及初始报告图像ID编号（如适用）、药品相关信息、不良反应相关信息、患者转归信息、报告来源信息，以及一份用于说明文件结构的README文件。下述2014年第三季度数据文件将包含额外字段。
如需了解更多详情，请参阅《2014年第三季度季度数据提取变更概要》（PDF，大小71 KB）