{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,4]],"date-time":"2026-10-04T00:35:17Z","timestamp":1791074117613,"version":"4.1.0"},"reference-count":27,"publisher":"American Medical Association (AMA)","issue":"2","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA Netw Open"],"abstract":"<jats:sec id=\"ab-zoi221524-4\">\n                    <jats:title>Importance<\/jats:title>\n                    <jats:p>Because of historical associations between vaccines and Guillain-Barr\u00e9 syndrome (GBS), the condition was a prespecified adverse event of special interest for COVID-19 vaccine monitoring.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"ab-zoi221524-5\">\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>To evaluate GBS reports to the Vaccine Adverse Event Reporting System (VAERS) and compare reporting patterns within 21 and 42 days after vaccination with Ad26.COV2.S (Janssen), BNT162b2 (Pfizer-BioNTech), and mRNA-1273 (Moderna) COVID-19 vaccines.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"ab-zoi221524-6\">\n                    <jats:title>Design, Setting, and Participants<\/jats:title>\n                    <jats:p>This retrospective cohort study was conducted using US VAERS reports submitted during December 2020 to January 2022. GBS case reports verified as meeting the Brighton Collaboration case definition for GBS in US adults after COVID-19 vaccination were included.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"ab-zoi221524-7\">\n                    <jats:title>Exposures<\/jats:title>\n                    <jats:p>Receipt of the Ad26.COV2.S, BNT162b2, or mRNA-1273 COVID-19 vaccine.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"ab-zoi221524-8\">\n                    <jats:title>Main Outcomes and Measures<\/jats:title>\n                    <jats:p>Descriptive analyses of GBS case were conducted. GBS reporting rates within 21 and 42 days after Ad26.COV2.S, BNT162b2, or mRNA-1273 vaccination based on doses administered were calculated. Reporting rate ratios (RRRs) after receipt of Ad26.COV2.S vs BNT162b2 or mRNA-1273 within 21- and 42-day postvaccination intervals were calculated. Observed-to-expected (OE) ratios were estimated using published GBS background rates.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"ab-zoi221524-9\">\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Among 487\u202f651\u202f785 COVID-19 vaccine doses, 17\u202f944\u202f515 doses (3.7%) were Ad26.COV2.S, 266\u202f859\u202f784 doses (54.7%) were BNT162b2, and 202\u202f847\u202f486 doses (41.6%) were mRNA-1273. Of 295 verified reports of individuals with GBS identified after COVID-19 vaccination (12 Asian [4.1%], 18 Black [6.1%], and 193 White [65.4%]; 17 Hispanic [5.8%]; 169 males [57.3%]; median [IQR] age, 59.0 [46.0-68.0] years), 275 reports (93.2%) documented hospitalization. There were 209 and 253 reports of GBS that occurred within 21 days and 42 days of vaccination, respectively. Within 21 days of vaccination, GBS reporting rates per 1\u202f000\u202f000 doses were 3.29 for Ad26.COV.2, 0.29 for BNT162b2, and 0.35 for mRNA-1273 administered; within 42 days of vaccination, they were 4.07 for Ad26.COV.2, 0.34 for BNT162b2, and 0.44 for mRNA-1273. GBS was more frequently reported within 21 days after Ad26.COV2.S than after BNT162b2 (RRR\u2009=\u200911.40; 95% CI, 8.11-15.99) or mRNA-1273 (RRR\u2009=\u20099.26; 95% CI, 6.57-13.07) vaccination; similar findings were observed within 42 days after vaccination (BNT162b2: RRR\u2009=\u200912.06; 95% CI, 8.86-16.43; mRNA-1273: RRR\u2009=\u20099.27; 95% CI, 6.80-12.63). OE ratios were 3.79 (95% CI, 2.88-4.88) for 21-day and 2.34 (95% CI, 1.83-2.94) for 42-day intervals after Ad26.COV2.S vaccination and less than 1 (not significantly increased) after BNT162b2 and mRNA-1273 vaccination within both postvaccination periods.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"ab-zoi221524-10\">\n                    <jats:title>Conclusions and Relevance<\/jats:title>\n                    <jats:p>This study found disproportionate reporting and imbalances after Ad26.COV2.S vaccination, suggesting that Ad26.COV2.S vaccination was associated with increased risk for GBS. No associations between mRNA COVID-19 vaccines and increased risk of GBS were observed.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1001\/jamanetworkopen.2022.53845","type":"journal-article","created":{"date-parts":[[2023,2,1]],"date-time":"2023-02-01T11:29:50Z","timestamp":1675250990000},"page":"e2253845","source":"Crossref","is-referenced-by-count":85,"title":["Reports of Guillain-Barr\u00e9 Syndrome After COVID-19 Vaccination in the United States"],"prefix":"10.1001","volume":"6","author":[{"given":"Winston E.","family":"Abara","sequence":"first","affiliation":[{"name":"COVID-19 Response Team, Centers for Disease Control and Prevention, Atlanta, Georgia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Julianne","family":"Gee","sequence":"additional","affiliation":[{"name":"COVID-19 Response Team, Centers for Disease Control and Prevention, Atlanta, Georgia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paige","family":"Marquez","sequence":"additional","affiliation":[{"name":"COVID-19 Response Team, Centers for Disease Control and Prevention, Atlanta, Georgia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jared","family":"Woo","sequence":"additional","affiliation":[{"name":"COVID-19 Response Team, Centers for Disease Control and Prevention, Atlanta, Georgia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tanya R.","family":"Myers","sequence":"additional","affiliation":[{"name":"COVID-19 Response Team, Centers for Disease Control and Prevention, Atlanta, Georgia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Allison","family":"DeSantis","sequence":"additional","affiliation":[{"name":"COVID-19 Response Team, Centers for Disease Control and Prevention, Atlanta, Georgia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jane A. G.","family":"Baumblatt","sequence":"additional","affiliation":[{"name":"Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emily Jane","family":"Woo","sequence":"additional","affiliation":[{"name":"Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Deborah","family":"Thompson","sequence":"additional","affiliation":[{"name":"Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Narayan","family":"Nair","sequence":"additional","affiliation":[{"name":"Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John R.","family":"Su","sequence":"additional","affiliation":[{"name":"COVID-19 Response Team, Centers for Disease Control and Prevention, Atlanta, Georgia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tom T.","family":"Shimabukuro","sequence":"additional","affiliation":[{"name":"COVID-19 Response Team, Centers for Disease Control and Prevention, Atlanta, Georgia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David K.","family":"Shay","sequence":"additional","affiliation":[{"name":"COVID-19 Response Team, Centers for Disease Control and Prevention, Atlanta, Georgia"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"10","published-online":{"date-parts":[[2023,2,1]]},"reference":[{"issue":"3","key":"zoi221524r1","doi-asserted-by":"publisher","first-page":"599","DOI":"10.1016\/j.vaccine.2010.06.003","article-title":"Guillain-Barr\u00e9 syndrome and Fisher syndrome: case definitions and guidelines for collection, analysis, and presentation of immunization safety data.","volume":"29","author":"Sejvar","year":"2011","journal-title":"Vaccine"},{"issue":"2","key":"zoi221524r3","doi-asserted-by":"publisher","first-page":"123","DOI":"10.1159\/000324710","article-title":"Population incidence of Guillain-Barr\u00e9 syndrome: a systematic review and meta-analysis.","volume":"36","author":"Sejvar","year":"2011","journal-title":"Neuroepidemiology"},{"issue":"8","key":"zoi221524r4","doi-asserted-by":"publisher","first-page":"469","DOI":"10.1038\/nrneurol.2014.121","article-title":"Guillain-Barr\u00e9 syndrome: pathogenesis, diagnosis, treatment and prognosis.","volume":"10","author":"van den Berg","year":"2014","journal-title":"Nat Rev Neurol"},{"issue":"10","key":"zoi221524r5","doi-asserted-by":"publisher","first-page":"939","DOI":"10.1016\/S1474-4422(08)70215-1","article-title":"Clinical features, pathogenesis, and treatment of Guillain-Barr\u00e9 syndrome.","volume":"7","author":"van Doorn","year":"2008","journal-title":"Lancet Neurol"},{"issue":"2","key":"zoi221524r6","doi-asserted-by":"publisher","first-page":"105","DOI":"10.1093\/oxfordjournals.aje.a112795","article-title":"Guillain-Barre syndrome following vaccination in the National Influenza Immunization Program, United States, 1976\u20141977.","volume":"110","author":"Schonberger","year":"1979","journal-title":"Am J Epidemiol"},{"issue":"12","key":"zoi221524r7","doi-asserted-by":"publisher","first-page":"1623","DOI":"10.1001\/jamainternmed.2021.6227","article-title":"Risk of Guillain-Barr\u00e9 syndrome following recombinant zoster vaccine in Medicare beneficiaries.","volume":"181","author":"Goud","year":"2021","journal-title":"JAMA Intern Med"},{"issue":"6","key":"zoi221524r8","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0067185","article-title":"Guillain-Barr\u00e9 syndrome, influenza vaccination, and antecedent respiratory and gastrointestinal infections: a case-centered analysis in the Vaccine Safety Datalink, 2009\u20132011.","volume":"8","author":"Greene","year":"2013","journal-title":"PLoS One"},{"issue":"9876","key":"zoi221524r9","doi-asserted-by":"publisher","first-page":"1461","DOI":"10.1016\/S0140-6736(12)62189-8","article-title":"Association between Guillain-Barr\u00e9 syndrome and influenza A (H1N1) 2009 monovalent inactivated vaccines in the USA: a meta-analysis.","volume":"381","author":"Salmon","year":"2013","journal-title":"Lancet"},{"issue":"19","key":"zoi221524r10","doi-asserted-by":"publisher","first-page":"1937","DOI":"10.1001\/jama.2020.19692","article-title":"Postapproval vaccine safety surveillance for COVID-19 vaccines in the US.","volume":"324","author":"Lee","year":"2020","journal-title":"JAMA"},{"issue":"16","key":"zoi221524r11","doi-asserted-by":"publisher","first-page":"1606","DOI":"10.1001\/jama.2021.16496","article-title":"Association of receipt of the Ad26.COV2.S COVID-19 vaccine with presumptive Guillain-Barr\u00e9 syndrome, February-July 2021.","volume":"326","author":"Woo","year":"2021","journal-title":"JAMA"},{"issue":"4","key":"zoi221524r12","doi-asserted-by":"publisher","DOI":"10.1001\/jamanetworkopen.2022.8879","article-title":"Incidence of Guillain-Barr\u00e9 syndrome after COVID-19 vaccination in the Vaccine Safety Datalink.","volume":"5","author":"Hanson","year":"2022","journal-title":"JAMA Netw Open"},{"issue":"9","key":"zoi221524r17","doi-asserted-by":"publisher","first-page":"1569","DOI":"10.1093\/infdis\/jiab628","article-title":"Expected rates of select adverse events after immunization for coronavirus disease 2019 vaccine safety monitoring.","volume":"225","author":"Abara","year":"2022","journal-title":"J Infect Dis"},{"issue":"10045","key":"zoi221524r19","doi-asserted-by":"publisher","first-page":"717","DOI":"10.1016\/S0140-6736(16)00339-1","article-title":"Guillain-Barr\u00e9 syndrome.","volume":"388","author":"Willison","year":"2016","journal-title":"Lancet"},{"issue":"6","key":"zoi221524r21","doi-asserted-by":"publisher","first-page":"980","DOI":"10.1093\/cid\/civ423","article-title":"Deaths reported to the vaccine adverse event reporting system, United States, 1997\u20132013.","volume":"61","author":"Moro","year":"2015","journal-title":"Clin Infect Dis"},{"issue":"19","key":"zoi221524r22","doi-asserted-by":"publisher","first-page":"1824","DOI":"10.1056\/NEJMoa2034201","article-title":"Interim results of a phase 1-2a trial of Ad26.COV2.S COVID-19 vaccine.","volume":"384","author":"Sadoff","year":"2021","journal-title":"N Engl J Med"},{"key":"zoi221524r23","doi-asserted-by":"publisher","first-page":"e935275","DOI":"10.12659\/AJCR.935275","article-title":"Guillain-Barr\u00e9 syndrome after Ad26.COV2.S vaccination.","volume":"23","author":"Thant","year":"2022","journal-title":"Am J Case Rep"},{"issue":"2","key":"zoi221524r24","doi-asserted-by":"publisher","first-page":"312","DOI":"10.1002\/ana.v90.2","article-title":"Guillain-Barr\u00e9 syndrome following ChAdOx1-S\/nCoV-19 vaccine.","volume":"90","author":"Maramattom","year":"2021","journal-title":"Ann Neurol"},{"issue":"2","key":"zoi221524r25","doi-asserted-by":"publisher","first-page":"315","DOI":"10.1002\/ana.v90.2","article-title":"Guillain\u2013Barr\u00e9 syndrome variant occurring after SARS-CoV-2 vaccination.","volume":"90","author":"Allen","year":"2021","journal-title":"Ann Neurol"},{"issue":"19","key":"zoi221524r26","doi-asserted-by":"publisher","first-page":"2712","DOI":"10.1016\/j.vaccine.2021.03.016","article-title":"The critical role of background rates of possible adverse events in the assessment of COVID-19 vaccine safety.","volume":"39","author":"Black","year":"2021","journal-title":"Vaccine"},{"key":"zoi221524r13","author":"US Department of Health and Human Services"},{"key":"zoi221524r18","doi-asserted-by":"crossref","DOI":"10.1002\/0471445428","volume-title":"Statistical Methods for Rates and Proportions","author":"Fleiss","year":"2003","edition":"3rd ed"},{"key":"zoi221524r2","unstructured":"Centers for Disease Control and Prevention. Guillain-Barr\u00e9 Syndrome and vaccines. Accessed May 21, 2022. https:\/\/www.cdc.gov\/vaccinesafety\/concerns\/guillain-barre-syndrome.html"},{"key":"zoi221524r14","unstructured":"Centers for Disease Control and Prevention. Vaccine adverse event reporting system (VAERS). Accessed May 21, 2022. https:\/\/www.cdc.gov\/vaccinesafety\/ensuringsafety\/monitoring\/vaers\/index.html"},{"key":"zoi221524r15","unstructured":"International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. Medical dictionary for regulatory activities. Accessed May 21, 2022. https:\/\/www.meddra.org\/"},{"key":"zoi221524r16","unstructured":"Centers for Disease Control and Prevention. COVID data tracker. Accessed May 21, 2022. https:\/\/covid.cdc.gov\/covid-data-tracker\/#vaccinations_vacc-total-admin-rate-total"},{"key":"zoi221524r20","unstructured":"Centers for Disease Control and Prevention. Reporting adverse events following vaccination. Accessed May 21, 2022. https:\/\/www.cdc.gov\/vaccinesafety\/hcproviders\/reportingadverseevents.html"},{"key":"zoi221524r27","unstructured":"Centers for Disease Control and Prevention. Summary document for interim clinical considerations for use of COVID-19 vaccines currently authorized or approved in the United States. Accessed May 21, 2022. https:\/\/www.cdc.gov\/vaccines\/covid-19\/downloads\/summary-interim-clinical-considerations.pdf"}],"container-title":["JAMA Network Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/jamanetwork.com\/journals\/jamanetworkopen\/articlepdf\/2800871\/abara_2023_oi_221524_1683660322.92961.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,5,12]],"date-time":"2023-05-12T11:00:35Z","timestamp":1683889235000},"score":1,"resource":{"primary":{"URL":"https:\/\/jamanetwork.com\/journals\/jamanetworkopen\/fullarticle\/2800871"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,2,1]]},"references-count":27,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2023,2,1]]}},"URL":"https:\/\/doi.org\/10.1001\/jamanetworkopen.2022.53845","relation":{},"ISSN":["2574-3805"],"issn-type":[{"value":"2574-3805","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,2,1]]}}}