{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,10]],"date-time":"2026-10-10T01:38:41Z","timestamp":1791596321062,"version":"4.3.4"},"reference-count":43,"publisher":"Oxford University Press (OUP)","issue":"3","funder":[{"DOI":"10.13039\/100000038","name":"U.S. Food and Drug Administration","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100000038","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100005227","name":"Centers for Medicare and Medicaid Services","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100005227","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2021,2,13]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>The Vaccine Safety Datalink (VSD) identified a statistical signal for an increased risk of Guillain-Barr\u00e9 syndrome (GBS) in days 1\u201342 after 2018\u20132019 high-dose influenza vaccine (IIV3-HD) administration. We evaluated the signal using Medicare.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>We conducted early- and end-of-season claims-based self-controlled risk interval analyses among Medicare beneficiaries ages \u226565 years, using days 8\u201321 and 1\u201342 postvaccination as risk windows and days 43\u201384 as control window. The VSD conducted chart-confirmed analyses.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Among 7 453 690 IIV3-HD vaccinations, we did not detect a statistically significant increased GBS risk for either the 8- to 21-day (odds ratio [OR], 1.85; 95% confidence interval [CI], 0.99\u20133.44) or 1- to 42-day (OR, 1.31; 95% CI, 0.78\u20132.18) risk windows. The findings from the end-of-season analyses were fully consistent with the early-season analyses for both the 8- to 21-day (OR, 1.64; 95% CI, 0.92\u20132.91) and 1- to 42-day (OR, 1.12; 95% CI, 0.70\u20131.79) risk windows. The VSD\u2019s chart-confirmed analysis, involving 646 996 IIV3-HD vaccinations, with 1 case each in the risk and control windows, yielded a relative risk of 1.00 (95% CI, 0.06\u201315.99).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>The Medicare analyses did not exclude an association between IIV3-HD and GBS, but it determined that, if such a risk existed, it was similar in magnitude to prior seasons. Chart-confirmed VSD results did not confirm an increased risk of GBS.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/infdis\/jiaa543","type":"journal-article","created":{"date-parts":[[2020,9,9]],"date-time":"2020-09-09T19:12:24Z","timestamp":1599678744000},"page":"416-425","source":"Crossref","is-referenced-by-count":29,"title":["Guillain-Barr\u00e9 Syndrome After High-Dose Influenza Vaccine Administration in the United States, 2018\u20132019 Season"],"prefix":"10.1093","volume":"223","author":[{"given":"Silvia","family":"Perez-Vilar","sequence":"first","affiliation":[{"name":"Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mao","family":"Hu","sequence":"additional","affiliation":[{"name":"Acumen LLC, Burlingame, California, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eric","family":"Weintraub","sequence":"additional","affiliation":[{"name":"Immunization Safety Office, Centers for Disease Control and Prevention, Atlanta, Georgia, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Deepa","family":"Arya","sequence":"additional","affiliation":[{"name":"Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bradley","family":"Lufkin","sequence":"additional","affiliation":[{"name":"Acumen LLC, Burlingame, California, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tanya","family":"Myers","sequence":"additional","affiliation":[{"name":"Immunization Safety Office, Centers for Disease Control and Prevention, Atlanta, Georgia, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emily 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