Association rule mining in the US Vaccine Adverse Event Reporting System (VAERS )

Purpose Spontaneous adverse event reporting systems are critical tools for monitoring the safety of licensed medical products. Commonly used signal detection algorithms identify disproportionate product–adverse event pairs and may not be sensitive to more complex potential signals. We sought to develop a computationally tractable multivariate data‐mining approach to identify product–multiple adverse event associations. Methods We describe an application of stepwise association rule mining (Step‐ARM) to detect potential vaccine‐symptom group associations in the US Vaccine Adverse Event Reporting System. Step‐ARM identifies strong associations between one vaccine and one or more adverse events. To reduce the number of redundant association rules found by Step‐ARM, we also propose a clustering method for the post‐processing of association rules. Results In sample applications to a trivalent intradermal inactivated influenza virus vaccine and to measles, mumps, rubella, and varicella (MMRV) vaccine and in simulation studies, we find that Step‐ARM can detect a variety of medically coherent potential vaccine‐symptom group signals efficiently. In the MMRV example, Step‐ARM appears to outperform univariate methods in detecting a known safety signal. Conclusions Our approach is sensitive to potentially complex signals, which may be particularly important when monitoring novel medical countermeasure products such as pandemic influenza vaccines. The post‐processing clustering algorithm improves the applicability of the approach as a screening method to identify patterns that may merit further investigation. Copyright © 2015 John Wiley & Sons, Ltd.