Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

                Data Mining

Data Mining Home
          Science & Research
          Data Mining
          Data Mining at the Center for Biologics Evaluation and ResearchData Mining Data Mining at the Center for Biologics Evaluation and Research
  
  	
    Share
    Post
    Linkedin

    Email
    PrintEvaluation of spontaneous reports of adverse events following the administration of CBER-regulated medical products remains a key component of CBER’s safety surveillance strategy. Continuing to improve the efficiency of analysis of this data and the validity of inferences drawn from it are important goals of CBER’s work in this area. CBER conducts disproportionality analysis (i.e., commonly referred to as data mining) of spontaneous reports for CBER regulated products in the Vaccine Adverse Event Reporting System (VAERS) and FDA Adverse Event Reporting System (FAERS) using Empirical Bayesian methods.

Data mining in the context of product safety surveillance refers to the use of statistical or mathematical tools to discover patterns of associations or unexpected occurrences in large databases, such as FAERS and VAERS. It involves the systematic examination of reported adverse events (AEs) to identify an excess of AEs reported for a product relative to other products in the database (disproportionality). Results from data mining are considered hypothesis generating and do not, by themselves, demonstrate causal associations.  By applying data mining techniques, FDA may be able to identify unusual or unexpected product-event combinations that warrant further investigation.

Potential limitations of data mining include spurious alerts from statistical interaction (e.g., due to concomitant exposures), dictionary constraints, confounding (e.g., by indication), and limitations inherent to passive reporting systems (e.g., stimulated reporting impacts, variable spontaneous reporting of different exposures and outcomes).  Unexpectedly high reporting associations may generate a hypothesis that there may be an association between the AE and the product. However, the absence of disproportionality does not confirm the absence of a safety signal nor negate a signal detected by other methods.

                                                                                  Content current as of:
      11/29/2022Data Mining
 
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop