{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,2]],"date-time":"2026-09-02T00:09:31Z","timestamp":1788307771205,"version":"build-2803163510"},"reference-count":20,"publisher":"Wiley","issue":"12","license":[{"start":{"date-parts":[[2012,7,16]],"date-time":"2012-07-16T00:00:00Z","timestamp":1342396800000},"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":[[2012,12]]},"abstract":"<jats:title>ABSTRACT<\/jats:title><jats:sec><jats:title>Purpose<\/jats:title><jats:p>A new meningococcal conjugate vaccine (MCV4) was introduced in 2005. Shortly after, case reports of Guillain\u2013Barr\u00e9 syndrome (GBS), a serious demyelinating disease, began to be reported to the Vaccine Adverse Event Reporting System. In 2006, the Centers for Disease Control and Prevention and the Food and Drug Administration requested the evaluation of GBS risk after MCV4 vaccination. We conducted a study to assess the risk of GBS after MCV4 vaccination using health plan administrative and claims data together with the review of primary medical records of potential cases.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Retrospective cohort study among 12.6 million 11\u2010 to 21\u2010year\u2010old members of five US health plans with a total membership of 50 million. Automated enrollment and medical claims data from March 2005 through August 2008 were used to identify the population, the vaccinations administered, and the medical services associated with possible GBS. Medical records were reviewed and adjudicated by a neurologist panel to confirm cases of GBS. The study used distributed data analysis methods that minimized sharing of protected health information.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>We confirmed 99 GBS cases during 18,322,800 person\u2010years (5.4\/1,000,000 person\u2010years). More than 1.4 million MCV4 vaccinations were observed. No confirmed cases of GBS occurred within 6 weeks after vaccination. The upper 95% CI for the attributable risk of GBS associated with MCV4 is estimated as 1.5 cases per 1,000,000 doses.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Among members of five US health plans, MCV4 vaccination was not associated with increased GBS risk. Copyright \u00a9 2012 John Wiley &amp; Sons, Ltd.<\/jats:p><\/jats:sec>","DOI":"10.1002\/pds.3321","type":"journal-article","created":{"date-parts":[[2012,7,16]],"date-time":"2012-07-16T06:15:48Z","timestamp":1342419348000},"page":"1350-1358","source":"Crossref","is-referenced-by-count":39,"title":["Risk of Guillain\u2013Barr\u00e9 syndrome after meningococcal conjugate vaccination"],"prefix":"10.1002","volume":"21","author":[{"given":"Priscilla","family":"Velentgas","sequence":"first","affiliation":[{"name":"Department of Population Medicine Harvard Medical School and Harvard Pilgrim Health Care Institute  Boston MA USA"},{"name":"Outcome Sciences, Inc.  Cambridge MA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anthony A.","family":"Amato","sequence":"additional","affiliation":[{"name":"Department of Neurology Brigham and Women's Hospital  Boston MA USA"},{"name":"Harvard Medical School  Boston MA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rhonda L.","family":"Bohn","sequence":"additional","affiliation":[{"name":"HealthCore, Inc.  Wilmington DE USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"K.","family":"Arnold Chan","sequence":"additional","affiliation":[{"name":"Department of Epidemiology Harvard School of Public Health  Boston MA USA"},{"name":"Optum Insight  Waltham MA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas","family":"Cochrane","sequence":"additional","affiliation":[{"name":"Department of Neurology Brigham and Women's Hospital  Boston MA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Donnie P.","family":"Funch","sequence":"additional","affiliation":[{"name":"Optum Insight  Waltham MA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Inna","family":"Dashevsky","sequence":"additional","affiliation":[{"name":"Department of Population Medicine Harvard Medical School and Harvard Pilgrim Health Care Institute  Boston MA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"April L.","family":"Duddy","sequence":"additional","affiliation":[{"name":"Department of Population Medicine Harvard Medical School and Harvard Pilgrim Health Care Institute  Boston MA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Patricia","family":"Gladowski","sequence":"additional","affiliation":[{"name":"Highmark Inc.  Pittsburgh PA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Steven A.","family":"Greenberg","sequence":"additional","affiliation":[{"name":"Department of Neurology Brigham and Women's Hospital  Boston MA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Judith M.","family":"Kramer","sequence":"additional","affiliation":[{"name":"Duke Clinical Research Institute Duke University Medical Center  Durham NC USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cheryl","family":"McMahill\u2010Walraven","sequence":"additional","affiliation":[{"name":"Aetna  Blue Bell PA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cynthia","family":"Nakasato","sequence":"additional","affiliation":[{"name":"Kaiser Permanente Center for Health Research  Hawai'i, Honolulu HI USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Claire M.","family":"Spettell","sequence":"additional","affiliation":[{"name":"Aetna  Blue Bell PA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Beth L.","family":"Syat","sequence":"additional","affiliation":[{"name":"Department of Population Medicine Harvard Medical School and Harvard Pilgrim Health Care Institute  Boston MA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter M.","family":"Wahl","sequence":"additional","affiliation":[{"name":"HealthCore, Inc.  Wilmington DE USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alexander M.","family":"Walker","sequence":"additional","affiliation":[{"name":"Department of Epidemiology Harvard School of Public Health  Boston MA USA"},{"name":"World Health Information Science Consultants  LLC, Newton MA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fang","family":"Zhang","sequence":"additional","affiliation":[{"name":"Department of Population Medicine Harvard Medical School and Harvard Pilgrim Health Care Institute  Boston MA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeffrey S.","family":"Brown","sequence":"additional","affiliation":[{"name":"Department of Population Medicine Harvard Medical School and Harvard Pilgrim Health Care Institute  Boston MA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Richard","family":"Platt","sequence":"additional","affiliation":[{"name":"Department of Population Medicine Harvard Medical School and Harvard Pilgrim Health Care Institute  Boston MA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2012,7,16]]},"reference":[{"issue":"7","key":"e_1_2_7_2_1","first-page":"1","article-title":"Prevention and control of meningococcal disease. Recommendations of the Advisory Committee on Immunization Practices (ACIP)","volume":"54","author":"Bilukha OO","year":"2005","journal-title":"MMWR Recomm Rep."},{"issue":"40","key":"e_1_2_7_3_1","first-page":"1023","article-title":"Guillain\u2013Barr\u00e9 syndrome among recipients of Menactra meningococcal conjugate vaccine\u2010\u2010United States, June\u2010July 2005","volume":"54","author":"Centers for Disease Control and Prevention","year":"2005","journal-title":"MMWR Morb Mortal Wkly Rep"},{"key":"e_1_2_7_4_1","doi-asserted-by":"publisher","DOI":"10.1002\/pds.1675"},{"key":"e_1_2_7_5_1","unstructured":"SejvarJJ KohlKS GiduduJet al.Guillain\u2013Barre Syndrome and Fisher Syndrome: Case definitions and guidelines for collection analysis and presentation of immunization safety data. Vaccine.2010. [Epub ahead of print]"},{"key":"e_1_2_7_6_1","doi-asserted-by":"publisher","DOI":"10.2307\/2531743"},{"key":"e_1_2_7_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/0197-2456(90)90005-M"},{"key":"e_1_2_7_8_1","doi-asserted-by":"publisher","DOI":"10.1002\/9780470316436"},{"key":"e_1_2_7_9_1","volume-title":"Biostatistics for Epidemiologists","author":"Ahlborn A","year":"1993"},{"key":"e_1_2_7_10_1","doi-asserted-by":"publisher","DOI":"10.1214\/ss\/1009213286"},{"key":"e_1_2_7_11_1","doi-asserted-by":"publisher","DOI":"10.1093\/biomet\/26.4.404"},{"key":"e_1_2_7_12_1","unstructured":"FDA's Sentinel Initiative.2009;http:\/\/www.fda.gov\/Safety\/FDAsSentinelInitiative\/default.htm. Accessed January 22 2010."},{"key":"e_1_2_7_13_1","unstructured":"BrownJS LaneK MooreK PlattR.Defining and Evaluating Possible Database Models to Implement the FDA Sentinel Initiative. Food and Drug Administration 2009. (Document ID FDA\u20102009\u2010N\u20100192\u20100005)."},{"key":"e_1_2_7_14_1","doi-asserted-by":"publisher","DOI":"10.1086\/533469"},{"key":"e_1_2_7_15_1","doi-asserted-by":"publisher","DOI":"10.1097\/00001648-199407000-00011"},{"issue":"41","key":"e_1_2_7_16_1","first-page":"1120","article-title":"Update: Guillain\u2013Barr\u00e9 Syndrome Among Recipients of Menactra\u00ae Meningococcal Conjugate Vaccine \u2010\u2010\u2010 United States, June 2005\u2010\u2010September 2006","volume":"55","author":"Centers for Disease Control and Prevention","year":"2006","journal-title":"Mortality and Morbidity Weekly Reports."},{"key":"e_1_2_7_17_1","doi-asserted-by":"publisher","DOI":"10.1093\/oxfordjournals.aje.a009369"},{"key":"e_1_2_7_18_1","doi-asserted-by":"publisher","DOI":"10.1093\/infdis\/175.Supplement_1.S151"},{"key":"e_1_2_7_19_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2036.2008.03827.x"},{"key":"e_1_2_7_20_1","doi-asserted-by":"publisher","DOI":"10.1097\/00005650-200411000-00005"},{"key":"e_1_2_7_21_1","doi-asserted-by":"publisher","DOI":"10.1007\/s100720200036"}],"container-title":["Pharmacoepidemiology and Drug Safety"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1002%2Fpds.3321","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1002%2Fpds.3321","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/pds.3321","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,11,21]],"date-time":"2023-11-21T04:25:46Z","timestamp":1700540746000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/pds.3321"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2012,7,16]]},"references-count":20,"journal-issue":{"issue":"12","published-print":{"date-parts":[[2012,12]]}},"alternative-id":["10.1002\/pds.3321"],"URL":"https:\/\/doi.org\/10.1002\/pds.3321","archive":["Portico"],"relation":{},"ISSN":["1053-8569","1099-1557"],"issn-type":[{"value":"1053-8569","type":"print"},{"value":"1099-1557","type":"electronic"}],"subject":[],"published":{"date-parts":[[2012,7,16]]}}}