Sold by: John Snow Labs
Deployed on AWS
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 2014.
Overview
Overview
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.
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 on AWS. The subscription will allow you to use all John Snow Labs datasets and data packages for commercial purposes.
Metadata
| Description | Value |
|---|---|
| Data Package Complexity | Medium |
| Available Enrichments | N/A |
| Keywords | Adverse Reaction, Adverse Events in Healthcare, Adverse Event Reporting Form, FAERS, Serious Adverse Event, Adverse Events Reporting System |
| Other Titles | FDA Adverse Event Reporting Guidance, Adverse Event Database by FDA 2014, FDA Post-Marketing Surveillance Reports 2014, FDA Drugs Causing Serious Adverse Effects 2014, FDA Reporting System of Adverse Effects 2014 |
Included Datasets
- FDA Adverse Events Reporting System Demographics 2014
FAERS database is designed to support the FDA’s post-marketing safety surveillance program for drug and therapeutic biologic products. The Demographics data file contains patient demographic and administrative information, a single record for each event report.
- FDA Adverse Events Reporting System Drug 2014
FAERS database is designed to support the FDA’s post-marketing safety surveillance program for drug and therapeutic biologic products. The Drug file 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 2014
FAERS database is designed to support the FDA’s post-marketing safety surveillance program for drug and therapeutic biologic products. The Indication file 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 2014
FAERS database is designed to support the FDA’s post-marketing safety surveillance program for drug and therapeutic biologic products. The Reaction file 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 2014
FAERS database is designed to support the FDA’s post-marketing safety surveillance program for drug and therapeutic biologic products. The Drug Therapy Dates file contains drug therapy start dates and end dates for the reported drugs (0 or more per drug per event).
- FDA Adverse Events Reporting System Patient Outcome 2014
FAERS database is designed to support the FDA’s post-marketing safety surveillance program for drug and therapeutic biologic products. The Outcome file contains patient outcomes for the event (0 or more).
- FDA Adverse Events Reporting System Report Source 2014
FAERS database is designed to support the FDA’s post-marketing safety surveillance program for drug and therapeutic biologic products. The Report Source file contains report sources for event (0 or more).
- FDA Adverse Events Reporting System Reporter Type 2014
FAERS database is designed to support the FDA’s post-marketing safety surveillance program for drug and therapeutic biologic products. The Reporter Type file contains counts and percentage of the reports submitted to the FDA during the quarter.
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 info@johnsnowlabs.com .
About Us
John Snow Labs , an AI and NLP for healthcare company, provides state-of-the-art software, models, and data to help healthcare and life science organizations build, deploy, and operate AI projects.
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Pricing
This product is available free of charge. Free subscriptions have no end date and may be canceled any time.
Additional AWS infrastructure costs may apply. Use the AWS Pricing Calculator to estimate your infrastructure costs.
Dimensions summary
This listing has one pricing dimension: Product Access (Units). It grants subscribers access to the dataset at no cost. There are no tiers, instance sizes, or usage-based add-ons to compare. You subscribe once to unlock access, and pricing does not scale with the number of records, users, or queries. Because the product is free, no charges apply to your bill for this dimension.
Top-of-mind questions for buyers
One unit unlocks access to the FAERS 2014 dataset for your subscription. There is no metering by records, users, or queries. You subscribe once to gain access, and a single unit covers the full dataset at no cost.
Active data library subscriptions can be canceled at any time, which stops future renewal charges. However, the vendor does not reimburse subscriptions already paid. Since this listing is free, no charges apply, so cancellation does not affect your bill.
No. You run the software on your own infrastructure. It does not "call home," and no data or results are sent to the vendor. This design suits high-compliance environments handling sensitive information.
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Vendor refund policy
No refunds offered. For any questions email us at info@johnsnowlabs.com
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Delivery details
AWS Data Exchange (ADX)
AWS Data Exchange is a service that helps AWS easily share and manage data entitlements from other organizations at scale.
Additional details
You will receive access to the following data sets.
Data set name | Type | Historical revisions | Future revisions | Sensitive information | Data dictionaries | Data samples |
|---|---|---|---|---|---|---|
FDA Adverse Events Reporting System Demographics 2014 | All historical revisions | All future revisions | Not included | |||
FDA Adverse Events Reporting System Drug 2014 | All historical revisions | All future revisions | Not included | |||
FDA Adverse Events Reporting System Drug Indication 2014 | All historical revisions | All future revisions | Not included | |||
FDA Adverse Events Reporting System Drug Reaction 2014 | All historical revisions | All future revisions | Not included | |||
FDA Adverse Events Reporting System Drug Therapy Dates 2014 | All historical revisions | All future revisions | Not included | |||
FDA Adverse Events Reporting System Patient Outcome 2014 | All historical revisions | All future revisions | Not included | |||
FDA Adverse Events Reporting System Report Source 2014 | All historical revisions | All future revisions | Not included | |||
FDA Adverse Events Reporting System Reporter Type 2014 | All historical revisions | All future revisions | Not included |
Resources
Vendor resources
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