title: Data mining in the US Vaccine Adverse Event Reporting System (VAERS): early detection of intussusception and other events after rotavirus vaccination.
abstract: 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.
authors.affiliation: Vaccine Safety Branch, Division of Epidemiology, Office of Biostatistics and Epidemiology, Center for Biologic Evaluation and Research, US Food and Drug Administration, 1401 Rockville Pike, HFM-210, Rockville, MD 20852-1448, USA. niu@cber.fda.gov
authors.forename: M T
authors.initials: MT
authors.lastname: Niu
authors.forename: D E
authors.initials: DE
authors.lastname: Erwin
authors.forename: M M
authors.initials: MM
authors.lastname: Braun
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000706:statistics & numerical data*; D016667:Bacterial Capsules; D001499:Bayes Theorem; D015984:Causality; D022681:Diphtheria-Tetanus-acellular Pertussis Vaccines / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D006471:Gastrointestinal Hemorrhage / Q000453:epidemiology / Q000209:etiology; D018073:Haemophilus Vaccines / Q000009:adverse effects; D006801:Humans; D007223:Infant; D007415:Intestinal Obstruction / Q000453:epidemiology / Q000209:etiology; D007443:Intussusception / Q000453:epidemiology / Q000209:etiology*; D008297:Male; D011054:Poliovirus Vaccine, Inactivated / Q000009:adverse effects; D011135:Polysaccharides, Bacterial / Q000009:adverse effects; D012189:Retrospective Studies; D022243:Rotavirus Vaccines / Q000008:administration & dosage / Q000009:adverse effects*; D012449:Safety; D013997:Time Factors; D014481:United States / Q000453:epidemiology; D014611:Vaccination / Q000009:adverse effects*
chemical_list: D022681:Diphtheria-Tetanus-acellular Pertussis Vaccines; D018073:Haemophilus Vaccines; C044237:Haemophilus influenzae type b polysaccharide vaccine; D011054:Poliovirus Vaccine, Inactivated; D011135:Polysaccharides, Bacterial; D022243:Rotavirus Vaccines