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

Abstract

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.

• Authors: Lai Wei, John Scott
• Journal: Pharmacoepidemiology and drug safety (Pharmacoepidemiol Drug Saf) Vol. 24 Issue 9 Pg. 922-33 (Sep 2015) ISSN: 1099-1557 [Electronic] England
• PMID: 26045284 (Publication Type: Journal Article, Research Support, U.S. Gov't, Non-P.H.S., Research Support, U.S. Gov't, P.H.S.)
• Copyright: Copyright © 2015 John Wiley & Sons, Ltd.

Chemical References

• Chickenpox Vaccine
• Influenza Vaccines
• Measles-Mumps-Rubella Vaccine
• Vaccines, Combined
• measles, mumps, rubella, varicella vaccine

Topics

• Adverse Drug Reaction Reporting Systems
• Chickenpox Vaccine (adverse effects)
• Data Mining (methods)
• Drug-Related Side Effects and Adverse Reactions (diagnosis, epidemiology)
• Humans
• Influenza Vaccines (adverse effects)
• Measles-Mumps-Rubella Vaccine (adverse effects)
• Multivariate Analysis
• United States (epidemiology)
• Vaccines, Combined (adverse effects)