FDA Adverse Events Reporting System Drug 2020

$716 / year

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 2020. The Drug dataset contains drug/biologic information for as many medications as were reported for the event (1 or more per event).

Complexity

FAERS (FDA Adverse Event Reporting System) is designed to support the FDA’s post-marketing safety surveillance program for drug and therapeutic biologic products. It is a useful tool for FDA (U.S. Food and Drug Administration) for activities such as looking for new safety concerns that might be related to a marketed product, evaluating a manufacturer’s compliance to 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. If a potential safety concern is identified in FAERS, further evaluation is performed. Further evaluation might include conducting studies using other large databases, such as those available in the Sentinel System. Based on an evaluation of the potential safety concern, FDA may take regulatory action(s) to improve product safety and protect the public health, such as updating a product’s labeling information, restricting the use of the drug, communicating new safety information to the public, or, in rare cases, removing a product from the market.

The reports in FAERS 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 FDA.

Date Created

2020-04-30

Last Modified

2020-04-30

Version

2020-04-30

Update Frequency

Quarterly

Temporal Coverage

2020-01-01 to 2020-04-30

Spatial Coverage

United States

Source

John Snow Labs; U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Surveillance and Epidemiology (OSE);

Source License URL

Source License Requirements

N/A

Source Citation

N/A

Keywords

FAERS Database, Adverse Reaction, Adverse Events of Medication, Adverse Event Reporting Form, FAERS, Serious Adverse Event, Adverse Events Reporting System

Other Titles

FDA Adverse Events Reporting System Drugs Quarterly Report 2020, FDA Adverse Events Reporting System US Drugs 2020, FAERS Drugs Report 2020

NameDescriptionTypeConstraints
YearThe year in which the data was submitteddaterequired : 1
QuarterThe quarter of the year in which the data was submittedstringrequired : 1 enum : Array
Primary_IdNumber for identifying a FAERS report. This is the primary link field (primary key) between data files. This is a concatenated key of Case_Id and Case_Version_Number. It is the Identifier for the case sequence (version) number as reported by the manufacturerintegerlevel : Nominal required : 1
Case_IdCase number for identifying a FAERS case.integerlevel : Nominal required : 1
Drug_Sequence_NumberSequence number for identifying a drug for a Case. To link to the "Drug Therapy Dates" file, both the Primary_Id (primary key) and the Drug_Sequence_Number (secondary key) are needed.integerlevel : Ordinal required : 1
Role_of_Drug_in_EventCode for drug's reported role in event.string-
Drug_NameName of medicinal product. If a "Valid Trade Name" is populated for this ISR (Individual Safety Report), then Drug_Name = Valid Trade Name; if not, then Drug_Name = "Verbatim" name, exactly as entered on the report. For the great majority of reports, there is a "Valid Trade Name."string-
Product_Active_IngredientActive Ingredient of the product, when availablestring-
Source_of_Drug_NameCode for source of Drug_Name, either validated trade name or verbatim name.string-
Route_of_AdministrationThe route of drug administrationstring-
Dose_Verbatim_TextVerbatim text for dose, frequency, and route, exactly as entered on report.string-
Cumulative_Dose_to_First_ReactionCumulative dose to first reaction of the drugnumberlevel : Ratio
Unit_of_Cumulative_Dose_to_First_ReactionCumulative dose to first reaction unitstring-
Dechallenge_CodeDechallenge code, indicating if reaction abated when drug therapy was stoppedstring-
Rechallenge_CodeRechallenge code, indicating if reaction recurred when drug therapy was restartedstring-
Drug_Lot_NumberLot number of the drugstring-
Drug_Expiration_DateExpiration date of the drug. If a complete date is not available, a partial date is provideddate-
NDA_NumberNDA (New Drug Application) number of the drugstring-
Dose_AmountAmount of drug dose reportednumberlevel : Ratio
Dose_Unitstring-
Drug_Dosage_FormForm of drug dosage reportedstring-
Dose_FrequencyFrequency of dose reportedstring-
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<a class="lb-txt-none lb-txt" href="/s3/getting-started/?nc=sn&amp;loc=6&amp;dn=1"> Getting started</a>
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<h1 id="Amazon_S3" class="lb-txt-bold lb-txt-white lb-none-v-margin lb-h1-large lb-title"> Amazon S3</h1>
<h3 id="Object_storage_built_to_store_and_retrieve_any_amount_of_data_from_anywhere" class="lb-txt-light lb-txt-white lb-small-v-margin lb-h3 lb-title" style="margin-top:0px; margin-bottom:30px;"> Object storage built to store and retrieve any amount of data from anywhere</h3>
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<a class="lb-btn-a-primary" href="https://s3.console.aws.amazon.com/s3/home" role="button"> <span> Get started with Amazon S3</span> </a>
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<a class="lb-btn-a" href="https://pages.awscloud.com/ln_NAMER_AmazonS3-Contact-Us.html" role="button"> <span> Request more information</span> </a>
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<p>Amazon Simple Storage Service (Amazon S3) is an object storage service that offers industry-leading scalability data availability security and performance. This means customers of all sizes and industries can use it to store and protect any amount of data for a range of use cases such as websites mobile applications backup and restore archive enterprise applications IoT devices and big data analytics. Amazon S3 provides easy-to-use management features so you can organize your data and configure finely-tuned access controls to meet your specific business organizational and compliance requirements. Amazon S3 is designed for 99.999999999% (11 9's) of durability and stores data for millions of applications for companies all around the world.<br /> </p>
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<h3 id="Industry-leading_performance.2C_scalability.2C_availability.2C_and_durability" class="lb-txt-bold lb-txt-none lb-txt-18 lb-h3 lb-title" style="color:#232f3e;"> Industry-leading performance scalability availability and durability</h3>
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<p>Scale your storage resources up and down to meet fluctuating demands without upfront investments or resource procurement cycles. Amazon S3 is designed for 99.999999999% (11 9’s) of data durability because it automatically creates and stores copies of all S3 objects across multiple systems. This means your data is available when needed and protected against failures errors and threats.<br /> <a href="/s3/faqs/#Durability_.26_Data_Protection" target="_blank">Learn about S3 data durability &raquo;</a></p>
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<h3 id="Wide_range_of_cost-effective_storage_classes" class="lb-txt-bold lb-txt-none lb-txt-18 lb-h3 lb-title" style="color:#232f3e;"> Wide range of cost-effective storage classes</h3>
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<p>Save costs without sacrificing performance by storing data across the <b>S3 Storage Classes</b> which support different data access levels at corresponding rates. You can use <b>S3 Storage Class Analysis</b> to discover data that should move to a lower-cost storage class based on access patterns and configure an <b>S3 Lifecycle</b> policy to execute the transfer. You can also store data with changing or unknown access patterns in <b>S3 Intelligent-Tiering</b> which tiers objects based on changing access patterns and automatically delivers cost savings.<br /> <a href="/s3/storage-classes/">Learn more about the S3 Storage Classes &raquo;</a></p>
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<p>Store your data in Amazon S3 and secure it from unauthorized access with encryption features and access management tools. S3 is the only object storage service that allows you to block public access to all of your objects at the bucket or the account level with <b><a href="/s3/features/block-public-access/" target="_blank">S3 Block Public Access</a></b>. S3 maintains compliance programs such as PCI-DSS HIPAA/HITECH FedRAMP EU Data Protection Directive and FISMA to help you meet regulatory requirements. S3 integrates with <a href="/macie/" target="_blank">Amazon Macie</a> to discover and protect your sensitive data. AWS also supports numerous auditing capabilities to monitor access requests to your S3 resources.<br /> Learn more about <a href="/s3/features/#Access_management_and_security">S3 security</a> and <a href="/compliance/">compliance &raquo;</a></p>
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<h3 id="Easily_manage_data_and_access_controls" class="lb-txt-bold lb-txt-none lb-txt-18 lb-h3 lb-title" style="color:#232f3e;"> Easily manage data and access controls</h3>
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<p>S3 gives you robust capabilities to manage access cost replication and data protection. S3 Access Points make it easy to manage data access with specific permissions for your applications using a shared data set. S3 Replication features manage data replication within the region or to other regions. S3 Batch Operations helps manage large scale changes across billions of objects. S3 integration with Amazon Macie automatically provides an inventory of buckets and continually evaluates your S3 buckets to alert you to any unencrypted buckets publicly accessible buckets or buckets shared with AWS accounts. Since S3 works with AWS Lambda you can log activities define alerts and automate workflows without managing additional infrastructure.</p>
<p><a href="/s3/features/#Storage_management_and_monitoring">Learn more about S3 storage management features &raquo;</a></p>
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<p>Run big data analytics across your S3 objects (and other data sets in AWS) with our query-in-place services. Use <b>Amazon Athena</b> to query S3 data with standard SQL expressions and <b>Amazon Redshift Spectrum</b> to analyze data that is stored across your AWS data warehouses and S3 resources. You can also use <b>S3 Select </b>to retrieve subsets of object data instead of the entire object and improve query performance by up to 400%.<br /> <a href="/s3/features/#Query_in_place">Learn more about query in place &raquo;</a></p>
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<p>Store and protect your data in Amazon S3 by working with a partner from the <b>AWS Partner Network (APN)</b> — the largest community of technology and consulting cloud services providers. The APN recognizes migration partners that transfer data to Amazon S3 and storage partners that offer S3-integrated solutions for primary storage backup and restore archive and disaster recovery. You can also purchase an AWS-integrated solution directly from the <b>AWS Marketplace</b> which lists over 250 storage-specific offerings.<a href="/backup-recovery/partner-solutions/"><br /> Learn about the APN</a> and<a href="https://aws.amazon.com/marketplace"> AWS Marketplace &raquo;</a></p>
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<p><b><a name="preview"></a>&nbsp;</b>Amazon S3 Access Points simplifies managing data access at scale for applications using shared data sets on S3. With S3 Access Points you can now easily create hundreds of access points per bucket representing a new way of provisioning access to shared data sets. Access Points provide a customized path into a bucket with a unique hostname and access policy that enforces the specific permissions and network controls for any request made through the access point.</p>
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<p>Build scalable durable and secure backup and restore solutions with Amazon S3 and other AWS services such as <b>S3 Glacier</b> <b>Amazon EFS</b> and <b>Amazon EBS</b> to augment or replace existing on-premises capabilities. AWS and APN partners can help you meet Recovery Time Objectives (RTO) Recovery Point Objectives (RPO) and compliance requirements. With AWS you can back up data already in the AWS Cloud or use<b> AWS Storage Gateway</b> a hybrid storage service to send backups of on-premises data to AWS.<br /> <a href="/backup-restore/">Learn more about backup and restore &raquo;</a></p>
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<p>Protect critical data applications and IT systems that are running in the AWS Cloud or in your on-premises environment without incurring the expense of a second physical site. With Amazon S3 storage <b>S3 Cross-Region Replication</b> and other AWS compute networking and database services you can create DR architectures in order to quickly and easily recover from outages caused by natural disasters system failures and human errors.<a href="/disaster-recovery/"><br /> Learn more about DR &raquo;</a></p>
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<p>Retire physical infrastructure and archive data with <b>S3 Glacier</b> and <b>S3 Glacier Deep Archive</b>. These S3 Storage Classes retain objects long-term at the lowest rates. Simply create an S3 Lifecycle policy to archive objects throughout their lifecycles or upload objects directly to the archival storage classes. With <b>S3 Object Lock</b> you can apply retention dates to objects to protect them from deletions and meet compliance requirements. Unlike tape libraries S3 Glacier lets you restore archived objects in as little as one minute for expedited retrievals and 3-5 hours for standard retrievals. Bulk data restores from S3 Glacier and all restores from S3 Glacier Deep Archive are completed within 12 hours.<a href="/glacier/"><br /> Learn more about archiving &raquo;</a></p>
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<p>Accelerate innovation by building a <a href="/products/storage/data-lake-storage/" target="_blank">data lake on Amazon S3</a> and extract valuable insights using query-in-place analytics and machine learning tools. As your data lake grows use S3 Access Points to easily configure access to your data with specific permissions for each application or sets of applications. You can also use <b>AWS Lake Formation </b>to quickly create a data lake and centrally define and enforce security governance and auditing policies. The service collects data across your databases and S3 resources moves it into a new data lake in Amazon S3 and cleans and classifies it using machine learning algorithms. All AWS resources can be scaled up to accommodate your expanding data stores&nbsp;— without upfront investments.<br /> Learn more about building a <a href="/products/storage/data-lake-storage/" target="_blank">data lake on Amazon S3</a>&nbsp;and <a href="/lake-formation/">AWS Lake Formation &raquo;</a></p>
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<p><b>AWS Storage Gateway</b>&nbsp;lets you seamlessly connect and extend your on-premises applications to AWS Storage all while caching data locally for low-latency access. You can also automate data transfers between on-premises storage and Amazon S3 by using <b>AWS DataSync</b> which can transfer data at speeds up to 10 times faster than open-source tools. You can also transfer files directly into and out of Amazon S3 with<b>&nbsp;</b>the<b> AWS Transfer Family&nbsp;</b>— a fully managed simple and seamless service that enables secure file exchanges with third parties using SFTP FTPS and FTP.&nbsp;Another way to enable a hybrid cloud storage environment is to work with a gateway provider from the APN.<br /> Learn more about <a href="/storagegateway/" target="_blank">AWS Storage Gateway &raquo;</a> <a href="/datasync/" target="_blank">AWS DataSync</a>&nbsp;&raquo;&nbsp;&nbsp;<a href="/aws-transfer-family/" target="_blank">AWS Transfer Family &raquo;</a>&nbsp;<br /> </p>
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<p>Build fast cost-effective mobile and Internet-based applications by using AWS services and Amazon S3 to store production data. With Amazon S3 you can upload any amount of data and access it anywhere in order to deploy applications faster and reach more end users. Storing data in Amazon S3 also means you have access to the latest AWS developer tools and services for machine learning and analytics to innovate and optimize your cloud-native applications.<br /> <a href="/products/developer-tools/">Learn more about cloud-native applications &raquo;</a></p>
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Georgia-Pacific builds a central data lake based on Amazon S3 allowing it to efficiently ingest and analyze structured and unstructured data at scale.
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Nasdaq stores up to seven years of data in Amazon S3 Glacier to meet industry regulation and compliance requirements. With AWS the company is enabled to restore data while optimizing its long-term storage costs.
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Sysco consolidates its data into a single data lake built on Amazon S3 and Amazon S3 Glacier to run analytics on its data and gain business insights.
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Nielsen built a new cloud-native local television rating platform capable of storing 30 petabytes of data in Amazon S3 and leveraging Amazon Redshift AWS Lambda and Amazon EMR.
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<p><b>AWS STORAGE BLOG</b></p>
<p><i>Querying data without servers or databases using Amazon S3 Select</i></p>
<p><a href="https://aws.amazon.com/blogs/storage/querying-data-without-servers-or-databases-using-amazon-s3-select/" target="_blank"><u>Learn more &raquo;</u></a><br /> </p>
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