Data mining in the US Vaccine Adverse Event Reporting System (VAERS): early detection of intussusception and other events after rotavirus vaccination

Vaccine. 2001 Sep 14;19(32):4627-34. doi: 10.1016/s0264-410x(01)00237-7.


The Vaccine Adverse Event Reporting System (VAERS) is the US passive surveillance system monitoring vaccine safety. A major limitation of VAERS is the lack of denominator data (number of doses of administered vaccine), an element necessary for calculating reporting rates. Empirical Bayesian data mining, a data analysis method, utilizes the number of events reported for each vaccine and statistically screens the database for higher than expected vaccine-event combinations signaling a potential vaccine-associated event. This is the first study of data mining in VAERS designed to test the utility of this method to detect retrospectively a known side effect of vaccination-intussusception following rotavirus (RV) vaccine. From October 1998 to December 1999, 112 cases of intussusception were reported. The data mining method was able to detect a signal for RV-intussusception in February 1999 when only four cases were reported. These results demonstrate the utility of data mining to detect significant vaccine-associated events at early date. Data mining appears to be an efficient and effective computer-based program that may enhance early detection of adverse events in passive surveillance systems.

MeSH terms

  • Adverse Drug Reaction Reporting Systems / statistics & numerical data*
  • Bacterial Capsules
  • Bayes Theorem
  • Causality
  • Diphtheria-Tetanus-acellular Pertussis Vaccines / administration & dosage
  • Diphtheria-Tetanus-acellular Pertussis Vaccines / adverse effects
  • Female
  • Gastrointestinal Hemorrhage / epidemiology
  • Gastrointestinal Hemorrhage / etiology
  • Haemophilus Vaccines / adverse effects
  • Humans
  • Infant
  • Intestinal Obstruction / epidemiology
  • Intestinal Obstruction / etiology
  • Intussusception / epidemiology
  • Intussusception / etiology*
  • Male
  • Poliovirus Vaccine, Inactivated / adverse effects
  • Polysaccharides, Bacterial / adverse effects
  • Retrospective Studies
  • Rotavirus Vaccines / administration & dosage
  • Rotavirus Vaccines / adverse effects*
  • Safety
  • Time Factors
  • United States / epidemiology
  • Vaccination / adverse effects*


  • Diphtheria-Tetanus-acellular Pertussis Vaccines
  • Haemophilus Vaccines
  • Haemophilus influenzae type b polysaccharide vaccine
  • Poliovirus Vaccine, Inactivated
  • Polysaccharides, Bacterial
  • Rotavirus Vaccines