Canada Vigilance Adverse Reaction Database

**Overview**
This data package Canada Vigilance Adverse Reaction Online Database contains information about suspected adverse reactions (also known as side effects) to health products. This data package includes data from 1965 to 2020-07-31.

**Description**
The Canada Vigilance Adverse Reaction dataset contains information about suspected adverse reactions (also known as side effects) to health products, captured from adverse reaction reports submitted to Health Canada by consumers and health professionals, who submit reports voluntarily, as well as by market authorization holders (manufacturers and distributors), who are required to submit reports according to the Food and Drugs Regulations. Information concerning vaccines used for immunization have only been included in the database since January 1, 2011.

Adverse reaction reports are submitted by:

Consumers and health professionals, who submit reports voluntarily
Manufacturers and distributors (also known as market authorization holders), who are required to submit reports according to the Food and Drugs Act.
This dataset has been collected primarily by a spontaneous surveillance system in which suspected adverse reactions to health products are reported to market authorization holders (manufacturers) and Health Canada on a voluntary basis.

Note: Inclusion of a particular reaction does not necessarily mean that it was caused by the suspected health product(s). Certain reported reactions may occur spontaneously. They provide a background rate in the general population and may have a temporal, but not necessarily a causal, relationship with the health product. The purpose of the Canada Vigilance Program is to detect possible signals of adverse reactions associated with health products. Additional scientific investigations are required to validate signals from the Canada Vigilance Program and to establish a cause and effect relationship between a health product and adverse reaction. The data provided do not represent all known safety information concerning the suspected health product(s) and should not be used in isolation to make decisions regarding an individual's treatment regimen; other sources of information, including the prescribing information for the product, should be consulted.

This data package comprises of 13 dataset extracted from the Canada Vigilance Adverse Reaction Online Database.

**Benefits**
- Useful for healthcare professional and practitioners for vaccine reporting system.

**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**
- [Drug Product Ingredients](https://www.johnsnowlabs.com/marketplace/drug-product-ingredients)
- This dataset provides the information about the Canada Vigilance Adverse Reaction active ingredients associated with all drugs. This dataset includes data from 1965 to 2022-10-31.
- [Drug Products](https://www.johnsnowlabs.com/marketplace/drug-products)
- This dataset provides the information about all Canada Vigilance Adverse Reaction drug names and their codes. This dataset includes data from 1965 to 2022-11-31.
- [Literature Reference](https://www.johnsnowlabs.com/marketplace/literature-reference)
- This dataset provides the information about Canada Vigilance Adverse Reaction literature references. This dataset includes data from 1965 to 2022-11-31.
- [Reaction Terms](https://www.johnsnowlabs.com/marketplace/reaction-terms)
- This dataset provides the information about Canada Vigilance Adverse Reaction reaction terms associated with report. This dataset includes data from 1965 to 2022-11-31.
- [Report Drug Indications](https://www.johnsnowlabs.com/marketplace/report-drug-indications)
- This dataset provides the information about Canada Vigilance Adverse Reaction indications associated with specific reports. This dataset includes data from 1965 to 2022-11-31.
- [Report Drugs](https://www.johnsnowlabs.com/marketplace/report-drugs)
- This dataset provides the information about Canada Vigilance Adverse Reaction drugs associated with specific reports. This dataset includes data from 1965 to 2022-11-31.
- [Report Links](https://www.johnsnowlabs.com/marketplace/report-links)
- This dataset provides the information about Canada Vigilance Adverse Reaction linked/duplicate reports presentation text associated with the code. This dataset includes data from 1965 to 2022-11-31.
- [VAR Reports](https://www.johnsnowlabs.com/marketplace/var-reports)
- This dataset provides the information about Canada Vigilance Adverse Reaction reports and patients. This dataset includes data from 1965 to 2022-10-31.

**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]).

**概览**
本数据包为《加拿大警戒不良反应在线数据库》（Canada Vigilance Adverse Reaction Online Database），收录了医疗产品的可疑不良反应（亦称不良反应）相关信息，数据覆盖时段为1965年至2020年7月31日。

**描述**
加拿大警戒不良反应数据集收录了由消费者、医疗专业人员自愿提交，以及上市许可持有人(market authorization holders，制造商与经销商)按照《食品药品法规》要求提交报告的不良反应报告中提取的医疗产品可疑不良反应（亦称不良反应）相关信息。用于免疫接种的疫苗相关信息自2011年1月1日起才纳入该数据库。

不良反应报告的提交方包括：
1. 消费者与医疗专业人员（自愿提交报告）
2. 制造商与经销商（亦称上市许可持有人），需按照《食品药品法案》提交报告。

本数据集主要基于自发监测系统(spontaneous surveillance system)收集：该系统中，医疗产品的可疑不良反应由上市许可持有人（制造商）与加拿大卫生部(Health Canada)以自愿形式接收报告。

**注意**：收录某一特定反应并不必然意味着该反应由可疑医疗产品引发。部分报告的反应可能自发出现，这类反应在普通人群中存在背景发生率，仅可能与医疗产品存在时间上的关联，而非必然存在因果关系。加拿大警戒项目的目的是检测与医疗产品相关的不良反应潜在信号。需开展额外科学研究以验证加拿大警戒项目识别出的信号，并明确医疗产品与不良反应之间的因果关系。本数据集提供的信息并非可疑医疗产品的全部已知安全信息，不应单独用于制定个体治疗方案；需参考其他信息来源，包括产品的处方信息。

本数据包包含从《加拿大警戒不良反应在线数据库》中提取的13个数据集。

**应用价值**
- 可用于医疗专业人员的疫苗报告系统，为其提供有力支持。

**许可信息**
约翰·斯诺实验室(John Snow Labs)数据集可免费用于个人用途与研究用途。如需商业使用，请订阅约翰·斯诺实验室官网的[数据资料库](https://www.johnsnowlabs.com/marketplace/)。订阅后可使用约翰·斯诺实验室旗下所有数据集与数据包开展商业活动。

**包含数据集**
- [药品活性成分](https://www.johnsnowlabs.com/marketplace/drug-product-ingredients)
本数据集收录与加拿大警戒不良反应相关的所有药品活性成分信息，数据覆盖时段为1965年至2022年10月31日。
- [药品信息](https://www.johnsnowlabs.com/marketplace/drug-products)
本数据集收录加拿大警戒不良反应数据库中所有药品名称及其编码信息，数据覆盖时段为1965年至2022年11月31日。
- [文献参考](https://www.johnsnowlabs.com/marketplace/literature-reference)
本数据集收录加拿大警戒不良反应相关的文献参考信息，数据覆盖时段为1965年至2022年11月31日。
- [反应术语](https://www.johnsnowlabs.com/marketplace/reaction-terms)
本数据集收录与不良反应报告相关的加拿大警戒不良反应术语信息，数据覆盖时段为1965年至2022年11月31日。
- [报告用药适应症](https://www.johnsnowlabs.com/marketplace/report-drug-indications)
本数据集收录与特定报告相关的加拿大警戒不良反应用药适应症信息，数据覆盖时段为1965年至2022年11月31日。
- [报告关联药品](https://www.johnsnowlabs.com/marketplace/report-drugs)
本数据集收录与特定报告相关的加拿大警戒不良反应关联药品信息，数据覆盖时段为1965年至2022年11月31日。
- [报告关联信息](https://www.johnsnowlabs.com/marketplace/report-links)
本数据集收录与编码相关的加拿大警戒不良反应关联/重复报告的说明文本信息，数据覆盖时段为1965年至2022年11月31日。
- [不良反应报告(VAR Reports)](https://www.johnsnowlabs.com/marketplace/var-reports)
本数据集收录加拿大警戒不良反应报告与患者相关信息，数据覆盖时段为1965年至2022年10月31日。

**数据工程概览**
**我们提供高质量数据**
- 每个数据集均经过三级质量审核
- 2次人工审核由领域专家完成
- 随后通过60余项自动化验证流程，确保每条数据均符合元数据与预设约束条件
- 数据已归一化至统一类型系统
- 所有日期、单位、编码、货币格式保持统一
- 所有空值均归一化为统一标准值
- 所有数据集与字段名称均符合SQL与Hive命名规范
- 数据与元数据
- 数据支持CSV与Apache Parquet两种格式，针对分布式Hadoop、Spark及MPP集群的高读取性能做了优化
- 元数据采用开放的Frictionless Data标准格式，所有字段均经过归一化与验证
- 数据更新
- 数据更新采用替换更新模式：过时的外键将被弃用，而非直接删除

**我们的数据集由领域专家精心整理并富集**
本数据集由医生、药师、公共卫生与医疗计费专家组成的团队手动整理富集：
- 字段名称、描述与归一化值均由真正理解其含义的专业人员选定
- 医疗与生命科学领域专家为每个数据集添加分类、搜索关键词、描述等附加信息
- 针对临床编码、服务提供者、药品及地理定位信息，同时支持手动与自动化数据富集流程
- 始终保持数据时效性，即便原始数据源需要手动操作才能获取更新
- 数据订阅者的支持服务由整理该数据集的领域专家直接提供
- 每个数据源的许可均经过人工核验，确保可免版权费用于商业使用与再分发

**需要帮助？**
如果您对我们的产品有任何疑问，请发送邮件至[[e-mail]](mailto:[e-mail])。

搜集汇总

背景与挑战

背景概述

加拿大警戒不良反应数据库包含1965年至2020年7月31日的健康产品疑似不良反应报告数据，涵盖药物成分、反应术语等多个子集，适用于医疗和研究人员。