{"doi":"10.1093/infdis/jiaa543","title":"Guillain-Barré Syndrome After High-Dose Influenza Vaccine Administration in the United States, 2018–2019 Season","abstract":"BACKGROUND: The Vaccine Safety Datalink (VSD) identified a statistical signal for an increased risk of Guillain-Barré syndrome (GBS) in days 1-42 after 2018-2019 high-dose influenza vaccine (IIV3-HD) administration. We evaluated the signal using Medicare. METHODS: We conducted early- and end-of-season claims-based self-controlled risk interval analyses among Medicare beneficiaries ages ≥65 years, using days 8-21 and 1-42 postvaccination as risk windows and days 43-84 as control window. The VSD conducted chart-confirmed analyses. RESULTS: 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], 0.99-3.44) or 1- to 42-day (OR, 1.31; 95% CI, 0.78-2.18) 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, 0.92-2.91) and 1- to 42-day (OR, 1.12; 95% CI, 0.70-1.79) risk windows. The VSD's 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, 0.06-15.99). CONCLUSIONS: 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.","journal":"The Journal of Infectious Diseases","year":2020,"id":101108,"datarank":0.0,"base_score":0.0,"endowment":0.0,"self_citation_contribution":0.0,"citation_network_contribution":0.0,"self_endowment_contribution":0.0,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":28,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9072,"is_data_producer":false,"deposit_databanks":null,"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2020-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":495483,"name":"Mao Hu","orcid":"0000-0001-5491-8392","position":1,"is_corresponding":false},{"id":360574,"name":"Eric Weintraub","orcid":"0000-0003-0375-0504","position":2,"is_corresponding":false},{"id":496539,"name":"Deepa Arya","orcid":null,"position":3,"is_corresponding":false},{"id":495484,"name":"Bradley Lufkin","orcid":"0000-0002-1333-6262","position":4,"is_corresponding":false},{"id":371270,"name":"Tanya R. Myers","orcid":"0000-0003-3213-8402","position":5,"is_corresponding":false},{"id":495485,"name":"Emily Jane Woo","orcid":"0000-0001-9540-1816","position":6,"is_corresponding":false},{"id":495486,"name":"An‐Chi Lo","orcid":"0009-0000-5244-4138","position":7,"is_corresponding":false},{"id":496540,"name":"Steve Chu","orcid":null,"position":8,"is_corresponding":false},{"id":495487,"name":"Madeline Swarr","orcid":"0009-0000-6294-4267","position":9,"is_corresponding":false},{"id":495488,"name":"Jiemin Liao","orcid":"0000-0001-6848-5532","position":10,"is_corresponding":false},{"id":495489,"name":"Michael Wernecke","orcid":"0000-0001-9553-3122","position":11,"is_corresponding":false},{"id":496541,"name":"Tom MaCurdy","orcid":null,"position":12,"is_corresponding":false},{"id":496542,"name":"Jeffrey A. Kelman","orcid":null,"position":13,"is_corresponding":false},{"id":74341,"name":"Steven A. Anderson","orcid":null,"position":14,"is_corresponding":false},{"id":330739,"name":"Jonathan Duffy","orcid":"0000-0002-8060-0940","position":15,"is_corresponding":false},{"id":495490,"name":"Richard A. Forshee","orcid":"0000-0002-5805-2837","position":16,"is_corresponding":false},{"id":495482,"name":"Silvia Pérez-Vilar","orcid":"0000-0003-1272-1502","position":0,"is_corresponding":true}],"reference_count":39,"raw_metadata":null,"created_at":"2026-07-18T22:39:38.259162Z","pmid":"33137184","pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}