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Evaluating Automated Approaches to Anaphylaxis Case Classification Using Unstructured Data from the FDA Sentinel System

    Basic Details

    In May 2008, the Food and Drug Administration launched the Sentinel Initiative, a multi‐year program for the establishment of a national electronic monitoring system for medical product safety that led, in 2016, to the launch of the full Sentinel System. Under the Mini‐Sentinel pilot, several algorithms for identifying health outcomes of interest, including one for anaphylaxis, were developed and evaluated using data available from the Sentinel common data model. The purpose of this work was to evaluate whether features extracted from unstructured narrative data using natural language processing (NLP) could be used to classify anaphylaxis cases.


    Robert Ball, Sengwee Toh, Jamie Nolan, Kevin Haynes, Richard Forshee, Taxiarchis Botsis

    Corresponding Author

    Robert Ball, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, FDA, Silver Spring, MD, USA. Email: