{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,18]],"date-time":"2026-07-18T07:41:07Z","timestamp":1784360467429,"version":"3.55.0"},"reference-count":19,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2018,2,15]],"date-time":"2018-02-15T00:00:00Z","timestamp":1518652800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pharmacoepidemiology and Drug"],"published-print":{"date-parts":[[2018,4]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Purpose<\/jats:title><jats:p>The objective of our study was to conduct a data mining analysis to identify potential adverse events (AEs) following MENACWY\u2010D using the tree\u2010temporal scan statistic in the Vaccine Safety Datalink population and demonstrate the feasibility of this method in a large distributed safety data setting.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Traditional pharmacovigilance techniques used in vaccine safety are generally geared to detecting AEs based on pre\u2010defined sets of conditions or diagnoses. Using a newly developed tree\u2010temporal scan statistic data mining method, we performed a pilot study to evaluate the safety profile of the meningococcal conjugate vaccine Menactra\u00ae (MenACWY\u2010D), screening thousands of potential AE diagnoses and diagnosis groupings. The study cohort included enrolled participants in the Vaccine Safety Datalink aged 11 to 18\u00a0years who had received MenACWY\u2010D vaccination(s) between 2005 and 2014. The tree\u2010temporal scan statistic was employed to identify statistical associations (signals) of AEs following MENACWY\u2010D at a 0.05 level of significance, adjusted for multiple testing.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>We detected signals for 2 groups of outcomes: diseases of the skin and subcutaneous tissue, fever, and urticaria. Both groups are known AEs following MENACWY\u2010D vaccination. We also identified a statistical signal for pleurisy, but further examination suggested it was likely a false signal. No new MENACWY\u2010D safety concerns were raised.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>As a pilot study, we demonstrated that the tree\u2010temporal scan statistic data mining method can be successfully applied to screen broadly for a wide range of vaccine\u2010AE associations within a large health care data network.<\/jats:p><\/jats:sec>","DOI":"10.1002\/pds.4397","type":"journal-article","created":{"date-parts":[[2018,2,15]],"date-time":"2018-02-15T09:52:45Z","timestamp":1518688365000},"page":"391-397","source":"Crossref","is-referenced-by-count":27,"title":["Meningococcal conjugate vaccine safety surveillance in the Vaccine Safety Datalink using a tree\u2010temporal scan data mining method"],"prefix":"10.1002","volume":"27","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0664-4803","authenticated-orcid":false,"given":"Rongxia","family":"Li","sequence":"first","affiliation":[{"name":"Immunization Safety Office Centers for Disease Control and Prevention Atlanta GA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eric","family":"Weintraub","sequence":"additional","affiliation":[{"name":"Immunization Safety Office Centers for Disease Control and Prevention Atlanta GA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael M.","family":"McNeil","sequence":"additional","affiliation":[{"name":"Immunization Safety Office Centers for Disease Control and Prevention Atlanta GA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Martin","family":"Kulldorff","sequence":"additional","affiliation":[{"name":"Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine Harvard Medical School and Brigham and Women's Hospital Boston MA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Edwin M.","family":"Lewis","sequence":"additional","affiliation":[{"name":"Kaiser Permanente Vaccine Study Center Oakland CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jennifer","family":"Nelson","sequence":"additional","affiliation":[{"name":"Group Health Research Institute and University of Washington Seattle WA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stanley","family":"Xu","sequence":"additional","affiliation":[{"name":"Institute for Health Research, Kaiser Permanente Denver CO USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lei","family":"Qian","sequence":"additional","affiliation":[{"name":"Southern California Kaiser Permanente Pasadena CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nicola P.","family":"Klein","sequence":"additional","affiliation":[{"name":"Kaiser Permanente Vaccine Study Center Oakland CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Frank","family":"Destefano","sequence":"additional","affiliation":[{"name":"Immunization Safety Office Centers for Disease Control and Prevention Atlanta GA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2018,2,15]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1155\/2000\/414396"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40264-013-0051-9"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0264-410X(01)00237-7"},{"issue":"3","key":"e_1_2_9_5_1","doi-asserted-by":"crossref","first-page":"177","DOI":"10.1080\/00031305.1999.10474456","article-title":"Bayesian data mining in large frequency tables, with application to the FDA spontaneous reporting system","volume":"53","author":"DuMouchel W","year":"1999","journal-title":"Am. 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CDC vaccine information sheet. https:\/\/www.cdc.gov\/vaccines\/hcp\/vis\/vis\u2010statements\/mening.pdf last updated on 3\/31\/2016."},{"key":"e_1_2_9_19_1","article-title":"et al","author":"Yih KW","journal-title":"Sentinel CBER\/Prism methods pilot of self\u2010controlled tree\u2010temporal scan analysis for Gardasil vaccine"},{"key":"e_1_2_9_20_1","doi-asserted-by":"publisher","DOI":"10.1542\/peds.2010-1722H"}],"container-title":["Pharmacoepidemiology and Drug Safety"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1002%2Fpds.4397","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/pds.4397","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,7,1]],"date-time":"2024-07-01T06:46:52Z","timestamp":1719816412000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/pds.4397"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2018,2,15]]},"references-count":19,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2018,4]]}},"alternative-id":["10.1002\/pds.4397"],"URL":"https:\/\/doi.org\/10.1002\/pds.4397","archive":["Portico"],"relation":{},"ISSN":["1053-8569","1099-1557"],"issn-type":[{"value":"1053-8569","type":"print"},{"value":"1099-1557","type":"electronic"}],"subject":[],"published":{"date-parts":[[2018,2,15]]}}}