FDA Drug Adverse Events Reporting System FAERS 2021

**Overview**
The Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) data package contains information on medication errors, quality complaints and drug-related adverse events that were submitted to FDA in 2021.

**Description**
FAERS data package is designed to support the FDA's post-marketing safety surveillance program for drug and therapeutic biologic products. It is a useful tool for activities such as looking for new safety concerns that might be related to a marketed product, evaluating a manufacturer's compliance with reporting regulations and responding to outside requests for information. The reports in FAERS are evaluated by clinical reviewers, in the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER), to monitor the safety of products after they are approved by FDA. These reports are submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others) and consumers (such as patients, family members, lawyers and others). Healthcare professionals and consumers may also report to the products’ manufacturers who then send these reports to the FDA. The datasets in FAERS data package contain much relevant information such as patient demographics, drug name, dose and route of administration, diagnosis and indication for use, therapy starts and ends date and patient outcome.

**Benefits**
- useful for physicians, pharmacists, pharmaceutical companies, medical students and patients (general public).
- faers database is available on fda’s website in raw form, whereas a john snow labs (jsl) customer gets it in a clean and normalized form ready to use and create his own custom reports.
- quarter-wise data merged into one file.
- easy to comprehend for the customers who are unfamiliar with the medical terminology as all abbreviated terms are replaced with full form, unlike faers original datasets which are full of abbreviations.
- datasets are available for the year 2014, 2015, 2016, 2017, 2018, 2019 and 2021.

**License Information**
The use of John Snow Labs datasets is free for personal and research purposes. For commercial use please subscribe to the [Data Library](https://www.johnsnowlabs.com/marketplace/) on John Snow Labs website. The subscription will allow you to use all John Snow Labs datasets and data packages for commercial purposes.

**Included Datasets**
- [FDA Adverse Events Reporting System Demographics 2021](https://www.johnsnowlabs.com/marketplace/fda-adverse-events-reporting-system-demographics-2021)
- The FDA Adverse Event Reporting System (FAERS) contains information on medication errors, quality complaints and drug-related adverse events that were submitted to the FDA (U.S. Food and Drug Administration) in 2021. The Demographics dataset contains patient demographic and administrative information, a single record for each event report.
- [FDA Adverse Events Reporting System Drug 2021](https://www.johnsnowlabs.com/marketplace/fda-adverse-events-reporting-system-drug-2021)
- The FDA Adverse Event Reporting System (FAERS) contains information on medication errors, quality complaints and drug-related adverse events that were submitted to FDA (U.S. Food and Drug Administration) in 2021. The Drug dataset contains drug/biologic information for as many medications as were reported for the event (1 or more per event).
- [FDA Adverse Events Reporting System Drug Indication 2021](https://www.johnsnowlabs.com/marketplace/fda-adverse-events-reporting-system-drug-indication-2021)
- The FDA Adverse Event Reporting System (FAERS) contains information on medication errors, quality complaints and drug-related adverse events that were submitted to the FDA (U.S. Food and Drug Administration) in 2021. The Indication dataset contains all "Medical Dictionary for Regulatory Activities" (MedDRA) terms coded for the indications for use (diagnoses) for the reported drugs (0 or more per drug per event).
- [FDA Adverse Events Reporting System Drug Reaction 2021](https://www.johnsnowlabs.com/marketplace/fda-adverse-events-reporting-system-drug-reaction-2021)
- The FDA Adverse Event Reporting System (FAERS) contains information on medication errors, quality complaints and drug-related adverse events that were submitted to FDA (U.S. Food and Drug Administration) in 2021. The drug reaction dataset contains all "Medical Dictionary for Regulatory Activities" (MedDRA) terms coded for the adverse event (1 or more).
- [FDA Adverse Events Reporting System Drug Therapy Dates 2021](https://www.johnsnowlabs.com/marketplace/fda-adverse-events-reporting-system-drug-therapy-dates-2021)
- The FDA Adverse Event Reporting System (FAERS) contains information on medication errors, quality complaints and drug-related adverse events that were submitted to FDA (U.S. Food and Drug Administration) in 2021. The drug therapy dates dataset contains drug therapy start dates and end dates for the reported drugs.
- [FDA Adverse Events Reporting System Patient Outcome 2021](https://www.johnsnowlabs.com/marketplace/fda-adverse-events-reporting-system-patient-outcome-2021)
- The FDA Adverse Event Reporting System (FAERS) contains information on medication errors, quality complaints and drug-related adverse events that were submitted to FDA (U.S. Food and Drug Administration) in 2021. The patient outcome file contains information on patient outcomes for the event (0 or more).
- [FDA Adverse Events Reporting System Report Source 2021](https://www.johnsnowlabs.com/marketplace/fda-adverse-events-reporting-system-report-source-2021)
- The FDA Adverse Event Reporting System (FAERS) contains information on medication errors, quality complaints and drug-related adverse events that were submitted to FDA (U.S. Food and Drug Administration) in 2021. The report source dataset contains report sources for event.

**Data Engineering Overview**
**We deliver high-quality data**
- Each dataset goes through 3 levels of quality review
- 2 Manual reviews are done by domain experts
- Then, an automated set of 60+ validations enforces every datum matches metadata & defined constraints
- Data is normalized into one unified type system
- All dates, unites, codes, currencies look the same
- All null values are normalized to the same value
- All dataset and field names are SQL and Hive compliant
- Data and Metadata
- Data is available in both CSV and Apache Parquet format, optimized for high read performance on distributed Hadoop, Spark & MPP clusters
- Metadata is provided in the open Frictionless Data standard, and its every field is normalized & validated
- Data Updates
- Data updates support replace-on-update: outdated foreign keys are deprecated, not deleted

**Our data is curated and enriched by domain experts**

Each dataset is manually curated by our team of doctors, pharmacists, public health & medical billing experts:
- Field names, descriptions, and normalized values are chosen by people who actually understand their meaning
- Healthcare & life science experts add categories, search keywords, descriptions and more to each dataset
- Both manual and automated data enrichment supported for clinical codes, providers, drugs, and geo-locations
- The data is always kept up to date – even when the source requires manual effort to get updates
- Support for data subscribers is provided directly by the domain experts who curated the data sets
- Every data source’s license is manually verified to allow for royalty-free commercial use and redistribution.

**Need Help?**
If you have questions about our products, contact us at [[e-mail]](mailto:[e-mail]).

**概述**
食品药品监督管理局（FDA）不良事件报告系统（FAERS）数据包包含2021年提交至FDA的药品错误、质量投诉及药物相关不良事件信息。

**描述**
FAERS数据包旨在支持FDA针对药品及治疗性生物制品的上市后安全监测项目。它是一项实用工具，可用于多种活动，例如查找可能与上市产品相关的新安全隐患、评估制造商对报告法规的合规性，以及响应外部信息请求。FAERS中的报告由药品评价与研究中心（CDER）和生物制品评价与研究中心（CBER）的临床评审员评估，以监测产品获批后的安全性。这些报告由医疗专业人员（如医生、药师、护士等）及消费者（如患者、家属、律师等）提交至FDA。医疗专业人员和消费者也可向产品制造商报告，再由制造商转交给FDA。FAERS数据包中的数据集包含大量相关信息，例如患者人口统计数据、药物名称、剂量与给药途径、诊断与使用适应症、治疗起止日期及患者结局。

**优势**
- 对医生、药师、制药公司、医学生及患者（普通公众）均有价值。
- FAERS数据库在FDA网站上以原始形式提供，而John Snow Labs（JSL）客户可获取经清洗和归一化的即用型版本，便于创建自定义报告。
- 季度数据合并为单一文件。
- 对于不熟悉医学术语的客户而言易于理解，因为所有缩写术语均替换为全称，这与充斥缩写的FAERS原始数据集不同。
- 数据集涵盖2014、2015、2016、2017、2018、2019及2021年的数据。

**许可信息**
John Snow Labs数据集的使用对个人及研究用途免费。商业用途请订阅John Snow Labs网站上的[数据图书馆](https://www.johnsnowlabs.com/marketplace/)。订阅后可将所有John Snow Labs数据集及数据包用于商业目的。

**包含的数据集**
- [FDA不良事件报告系统2021年人口统计数据集](https://www.johnsnowlabs.com/marketplace/fda-adverse-events-reporting-system-demographics-2021)
- 食品药品监督管理局（FDA）不良事件报告系统（FAERS）包含2021年提交至FDA的药品错误、质量投诉及药物相关不良事件信息。人口统计数据集包含患者人口统计及管理信息，每个事件报告对应一条记录。
- [FDA不良事件报告系统2021年药物数据集](https://www.johnsnowlabs.com/marketplace/fda-adverse-events-reporting-system-drug-2021)
- FAERS包含2021年提交至FDA的药品错误、质量投诉及药物相关不良事件信息。药物数据集包含事件中报告的所有药物/生物制品信息（每个事件1种或多种）。
- [FDA不良事件报告系统2021年药物适应症数据集](https://www.johnsnowlabs.com/marketplace/fda-adverse-events-reporting-system-drug-indication-2021)
- FAERS包含2021年提交至FDA的药品错误、质量投诉及药物相关不良事件信息。适应症数据集包含所有为报告药物的使用适应症（诊断）编码的“监管活动医学术语集（MedDRA）”术语（每个事件每种药物0个或多个）。
- [FDA不良事件报告系统2021年药物反应数据集](https://www.johnsnowlabs.com/marketplace/fda-adverse-events-reporting-system-drug-reaction-2021)
- FAERS包含2021年提交至FDA的药品错误、质量投诉及药物相关不良事件信息。药物反应数据集包含所有为不良事件编码的MedDRA术语（1个或多个）。
- [FDA不良事件报告系统2021年药物治疗日期数据集](https://www.johnsnowlabs.com/marketplace/fda-adverse-events-reporting-system-drug-therapy-dates-2021)
- FAERS包含2021年提交至FDA的药品错误、质量投诉及药物相关不良事件信息。药物治疗日期数据集包含报告药物的治疗开始和结束日期。
- [FDA不良事件报告系统2021年患者结局数据集](https://www.johnsnowlabs.com/marketplace/fda-adverse-events-reporting-system-patient-outcome-2021)
- FAERS包含2021年提交至FDA的药品错误、质量投诉及药物相关不良事件信息。患者结局文件包含事件的患者结局信息（0个或多个）。
- [FDA不良事件报告系统2021年报告来源数据集](https://www.johnsnowlabs.com/marketplace/fda-adverse-events-reporting-system-report-source-2021)
- FAERS包含2021年提交至FDA的药品错误、质量投诉及药物相关不良事件信息。报告来源数据集包含事件的报告来源。

**数据工程概述**
**我们交付高质量数据**
- 每个数据集经过三级质量审核
- 2次由领域专家进行的人工审核
- 随后，60多项自动化验证确保每条数据符合元数据及定义的约束
- 数据归一化为统一类型系统
- 所有日期、单位、编码、货币格式一致
- 所有空值归一化为相同值
- 所有数据集及字段名称符合SQL和Hive规范
- 数据与元数据
- 数据以CSV和Apache Parquet格式提供，针对分布式Hadoop、Spark及MPP集群优化了高读取性能
- 元数据遵循开放的无摩擦数据（Frictionless Data）标准，每个字段均经过归一化和验证
- 数据更新
- 数据更新支持更新替换机制：过时的外键将被弃用，而非删除

**我们的数据由领域专家精选并增强**

每个数据集均由我们的医生、药师、公共卫生及医疗计费专家团队人工精选：
- 字段名称、描述及归一化值由真正理解其含义的专业人员选定
- 医疗保健及生命科学专家为每个数据集添加类别、搜索关键词、描述等
- 支持针对临床编码、提供者、药物及地理位置的人工和自动化数据增强
- 数据始终保持最新——即使来源需要人工努力获取更新
- 数据订阅者的支持直接由精选数据集的领域专家提供
- 每个数据源的许可均经过人工验证，允许免版税商业使用和再分发

**需要帮助？**
如对我们的产品有疑问，请联系：[[e-mail]](mailto:[e-mail])