{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,30]],"date-time":"2026-09-30T16:58:48Z","timestamp":1790787528500,"version":"4.1.0"},"reference-count":24,"publisher":"MDPI AG","issue":"2","license":[{"start":{"date-parts":[[2022,1,18]],"date-time":"2022-01-18T00:00:00Z","timestamp":1642464000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Viruses"],"abstract":"<jats:p>Background: Venous thromboembolism (VTE)\u2014including deep vein thrombosis, pulmonary embolism, and cerebral venous sinus thrombosis (CVST)\u2014may occur early after vaccination against the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). We sought to describe the site, clinical characteristics, and outcomes of VTE after vaccination against SARS-CoV-2. Methods: In a prospective study using the Registro Informatizado de Enfermedad TromboEmb\u00f3lica (RIETE) platform, patients with VTE 4\u201330 days after vaccination against SARS-CoV-2 (1 February 2021 through 30 April 2021) were included. VTE patients recruited from the same centers into RIETE in the same months in 2018\u20132019 were selected as the reference group. All-cause mortality and major bleeding were the main study outcomes. Results: As of 30 April 2020, 102 patients with post-vaccination VTEs had been identified (28 after adenovirus-based vaccination [ChAdOx1 nCov-19; AstraZeneca] and 74 after mRNA-based vaccination [mRNA-1273; Moderna, and BNT162b2; Pfizer]). Compared with 911 historical controls, patients with VTE after adenovirus-based vaccination more frequently had CVST (10.7% vs. 0.4%, p &lt; 0.001) or thrombosis at multiple sites (17.9% vs. 1.3%, p &lt; 0.001), more frequently had thrombocytopenia (40.7% vs. 14.7%, p &lt; 0.001), and had higher 14-day mortality (14.3% vs. 0.7%; odds ratio [OR]: 25.1; 95% confidence interval [CI]: 6.7\u201394.9) and major bleeding rates (10.3% vs. 1.0%, OR: 12.03, 95% CI: 3.07\u201347.13). The site of thrombosis, accompanying thrombocytopenia, and 14-day mortality rates were not significantly different for patients with VTE after mRNA-based vaccination, compared with historical controls. Conclusions: Compared with historical controls, VTE after adenovirus-based vaccination against SARS-CoV-2 is accompanied by thrombocytopenia, occurs in unusual sites, and is associated with worse clinical outcomes.<\/jats:p>","DOI":"10.3390\/v14020178","type":"journal-article","created":{"date-parts":[[2022,1,18]],"date-time":"2022-01-18T22:47:32Z","timestamp":1642546052000},"page":"178","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":26,"title":["Venous Thrombosis within 30 Days after Vaccination against SARS-CoV-2 in a Multinational Venous Thromboembolism Registry"],"prefix":"10.3390","volume":"14","author":[{"given":"Behnood","family":"Bikdeli","sequence":"first","affiliation":[{"name":"Cardiovascular Medicine Division, Brigham and Women\u2019s Hospital, Harvard Medical School, Boston, MA 02115, USA"},{"name":"Center for Outcomes Research and Evaluation (CORE), Yale School of Medicine, New Haven, CT 06510, USA"},{"name":"Clinical Trials Center, Cardiovascular Research Foundation, New York, NY 10019, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4571-7721","authenticated-orcid":false,"given":"David","family":"Jim\u00e9nez","sequence":"additional","affiliation":[{"name":"Respiratory Department, Hospital Ram\u00f3n y Cajal and Universidad de Alcal\u00e1 (IRYCIS), 28034 Madrid, Spain"},{"name":"Centro de Investigaci\u00f3n Biom\u00e9dica en Red de Enfermedades Respiratorias (CIBERES), 28029 Madrid, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3096-4711","authenticated-orcid":false,"given":"Pablo","family":"Demelo-Rodriguez","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, Hospital General Universitario Gregorio Mara\u00f1\u00f3n, 28007 Madrid, Spain"},{"name":"Instituto de investigaci\u00f3n sanitaria Gregorio Mara\u00f1\u00f3n (IiSGM), 28007 Madrid, Spain"},{"name":"School of Medicine, Universidad Complutense de Madrid, 28040 Madrid, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1321-6866","authenticated-orcid":false,"given":"Francisco","family":"Galeano-Valle","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, Hospital General Universitario Gregorio Mara\u00f1\u00f3n, 28007 Madrid, Spain"},{"name":"Instituto de investigaci\u00f3n sanitaria Gregorio Mara\u00f1\u00f3n (IiSGM), 28007 Madrid, Spain"},{"name":"School of Medicine, Universidad Complutense de Madrid, 28040 Madrid, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jos\u00e9 Antonio","family":"Porras","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, Hospital Universitario Joan XXIII de Tarragona, 43005 Tarragona, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Raquel","family":"Barba","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, Hospital Rey Juan Carlos, 28933 Madrid, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2607-9717","authenticated-orcid":false,"given":"Cihan","family":"Ay","sequence":"additional","affiliation":[{"name":"Department of Medicine I - Clinical Division of Haematology and Haemostaseology, Medical University of Vienna, 1090 Vienna, Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9199-7883","authenticated-orcid":false,"given":"Radovan","family":"Mal\u00fd","sequence":"additional","affiliation":[{"name":"Department of Cardiovascular Medicine I, Faculty of Medicine, Charles University in Prague, University Hospital Hradec Kralove, 500 05 Hradec Kralove, Czech Republic"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrei","family":"Braester","sequence":"additional","affiliation":[{"name":"Department of Haematology, Azrieli Faculty of Medicine, Bar-Ilan University, 13195 Safed, Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2656-5467","authenticated-orcid":false,"given":"Egidio","family":"Imbalzano","sequence":"additional","affiliation":[{"name":"Department of Clinical and Experimental Medicine, A.O.U Policlinico \u201cG. Martino\u201d, 98124 Messina, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5039-6638","authenticated-orcid":false,"given":"Vladimir","family":"Rosa","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, Hospital Universitario Virgen de Arrixaca, 30120 Murcia, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ram\u00f3n","family":"Lecumberri","sequence":"additional","affiliation":[{"name":"Department of Haematology, Cl\u00ednica Universidad de Navarra, 31008 Pamplona, Spain"},{"name":"Center for Biomedical Research Network on Cardiovascular Diseases (CIBERCV), Instituto de Salud Carlos III, 28029 Madrid, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0613-1074","authenticated-orcid":false,"given":"Carmine","family":"Siniscalchi","sequence":"additional","affiliation":[{"name":"Department of Angiology, Azienda Ospedaliera Universitaria, 43126 Parma, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6566-9029","authenticated-orcid":false,"given":"\u00c1ngeles","family":"Fidalgo","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, Hospital Universitario de Salamanca, 37007 Salamanca, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8783-1920","authenticated-orcid":false,"given":"Salvador","family":"Ortiz","sequence":"additional","affiliation":[{"name":"Department of Statistics, Universidad Aut\u00f3noma Madrid, 28049 Madrid, Spain"},{"name":"S&H Medical Science Service, 28034 Madrid, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0494-0767","authenticated-orcid":false,"given":"Manuel","family":"Monreal","sequence":"additional","affiliation":[{"name":"Faculty of Health Sciences, Universidad Cat\u00f3lica San Antonio de Murcia (UCAM), 30107 Murcia, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"for the RIETE Investigators","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2022,1,18]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"139","DOI":"10.3233\/HAB-200420","article-title":"Global burden of COVID-19: Situational analyis and review","volume":"29","author":"Gebru","year":"2021","journal-title":"Hum. Antibodies"},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"1017","DOI":"10.1038\/s41591-020-0968-3","article-title":"Extrapulmonary manifestations of COVID-19","volume":"26","author":"Gupta","year":"2020","journal-title":"Nat. Med."},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"2950","DOI":"10.1016\/j.jacc.2020.04.031","article-title":"COVID-19 and Thrombotic or Thromboembolic Disease: Implications for Prevention, Antithrombotic Therapy, and Follow-Up: JACC State-of-the-Art Review","volume":"75","author":"Bikdeli","year":"2020","journal-title":"J. Am. Coll. Cardiol."},{"key":"ref_4","doi-asserted-by":"crossref","first-page":"1182","DOI":"10.1016\/j.chest.2020.11.005","article-title":"Incidence of VTE and Bleeding Among Hospitalized Patients with Coronavirus Disease 2019: A Systematic Review and Meta-analysis","volume":"159","author":"Rali","year":"2021","journal-title":"Chest"},{"key":"ref_5","doi-asserted-by":"crossref","first-page":"2548","DOI":"10.1001\/jama.2020.23422","article-title":"Diagnosis, Management, and Pathophysiology of Arterial and Venous Thrombosis in COVID-19","volume":"324","author":"Piazza","year":"2020","journal-title":"JAMA"},{"key":"ref_6","doi-asserted-by":"crossref","first-page":"2187","DOI":"10.1056\/NEJMoa2101544","article-title":"Safety and Efficacy of Single-Dose Ad26.COV2.S Vaccine against COVID-19","volume":"384","author":"Sadoff","year":"2021","journal-title":"N. Engl. J. Med."},{"key":"ref_7","doi-asserted-by":"crossref","first-page":"403","DOI":"10.1056\/NEJMoa2035389","article-title":"Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine","volume":"384","author":"Baden","year":"2021","journal-title":"N. Engl. J. Med."},{"key":"ref_8","doi-asserted-by":"crossref","first-page":"2603","DOI":"10.1056\/NEJMoa2034577","article-title":"Safety and efficacy of the BNT162b2 mRNA COVID-19 vaccine","volume":"383","author":"Polack","year":"2020","journal-title":"N. Engl. J. Med."},{"key":"ref_9","doi-asserted-by":"crossref","first-page":"881","DOI":"10.1016\/S0140-6736(21)00432-3","article-title":"Single-dose administration and the influence of the timing of the booster dose on immunogenicity and efficacy of ChAdOx1 nCoV-19 (AZD1222) vaccine: A pooled analysis of four randomised trials","volume":"397","author":"Voysey","year":"2021","journal-title":"Lancet"},{"key":"ref_10","doi-asserted-by":"crossref","first-page":"2254","DOI":"10.1056\/NEJMe2106315","article-title":"SARS-CoV-2 Vaccine-Induced Immune Thrombotic Thrombocytopenia","volume":"384","author":"Cines","year":"2021","journal-title":"N. Engl. J. Med."},{"key":"ref_11","doi-asserted-by":"crossref","first-page":"334","DOI":"10.1038\/d41586-021-00940-0","article-title":"How could a COVID vaccine cause blood clots? Scientists race to investigate","volume":"592","author":"Ledford","year":"2021","journal-title":"Nature"},{"key":"ref_12","doi-asserted-by":"crossref","first-page":"2124","DOI":"10.1056\/NEJMoa2104882","article-title":"Thrombosis and Thrombocytopenia after ChAdOx1 nCoV-19 Vaccination","volume":"384","author":"Schultz","year":"2021","journal-title":"N. Engl. J. Med."},{"key":"ref_13","doi-asserted-by":"crossref","first-page":"2202","DOI":"10.1056\/NEJMoa2105385","article-title":"Pathologic Antibodies to Platelet Factor 4 after ChAdOx1 nCoV-19 Vaccination","volume":"384","author":"Scully","year":"2021","journal-title":"N. Engl. J. Med."},{"key":"ref_14","doi-asserted-by":"crossref","first-page":"1964","DOI":"10.1056\/NEJMc2105869","article-title":"Thrombotic Thrombocytopenia after Ad26.COV2.S Vaccination","volume":"384","author":"Muir","year":"2021","journal-title":"N. Engl. J. Med."},{"key":"ref_15","doi-asserted-by":"crossref","first-page":"2092","DOI":"10.1056\/NEJMoa2104840","article-title":"Thrombotic Thrombocytopenia after ChAdOx1 nCov-19 Vaccination","volume":"384","author":"Greinacher","year":"2021","journal-title":"N. Engl. J. Med."},{"key":"ref_16","doi-asserted-by":"crossref","first-page":"2448","DOI":"10.1001\/jama.2021.7517","article-title":"US Case Reports of Cerebral Venous Sinus Thrombosis With Thrombocytopenia After Ad26.COV2.S Vaccination, March 2 to April 21, 2021","volume":"325","author":"See","year":"2021","journal-title":"JAMA"},{"key":"ref_17","doi-asserted-by":"crossref","first-page":"408","DOI":"10.1016\/j.jacc.2021.06.001","article-title":"Cerebral Venous Sinus Thrombosis in the US Population, after Adenovirus-based SARS-CoV-2 Vaccination, and After COVID-19","volume":"78","author":"Bikdeli","year":"2021","journal-title":"J. Am. Coll. Cardiol."},{"key":"ref_18","doi-asserted-by":"crossref","first-page":"2101111","DOI":"10.1183\/13993003.01111-2021","article-title":"Thrombotic complications of vaccination against SARS-CoV-2: What pharmacovigilance reports tell us\u2014And what they don\u2019t","volume":"58","author":"Konstantinides","year":"2021","journal-title":"Eur. Respir. J."},{"key":"ref_19","doi-asserted-by":"crossref","first-page":"1680","DOI":"10.1056\/NEJMoa2109908","article-title":"Clinical Features of Vaccine-Induced Immune Thrombocytopenia and Thrombosis","volume":"385","author":"Pavord","year":"2021","journal-title":"N. Engl. J. Med."},{"key":"ref_20","doi-asserted-by":"crossref","first-page":"1585","DOI":"10.1111\/jth.15341","article-title":"Recommendations for the clinical and laboratory diagnosis of vaccine-induced immune thrombotic thrombocytopenia (VITT) for SARS-CoV-2 infections: Communication from the ISTH SSC Subcommittee on Platelet Immunology","volume":"19","author":"Nazy","year":"2021","journal-title":"J. Thromb. Haemos."},{"key":"ref_21","doi-asserted-by":"crossref","first-page":"214","DOI":"10.1160\/TH17-07-0511","article-title":"Rationale, Design and Methodology of the Computerized Registry of Patients with Venous Thromboembolism (RIETE)","volume":"118","author":"Bikdeli","year":"2018","journal-title":"Thromb. Haemost."},{"key":"ref_22","doi-asserted-by":"crossref","first-page":"692","DOI":"10.1111\/j.1538-7836.2005.01204.x","article-title":"Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients","volume":"3","author":"Schulman","year":"2005","journal-title":"J. Thromb. Haemost."},{"key":"ref_23","doi-asserted-by":"crossref","first-page":"2100956","DOI":"10.1183\/13993003.00956-2021","article-title":"Vaccination against COVID-19: Insight from arterial and venous thrombosis occurrence using data from VigiBase","volume":"58","author":"Smadja","year":"2021","journal-title":"Eur. Respir. J."},{"key":"ref_24","doi-asserted-by":"crossref","first-page":"443","DOI":"10.1016\/j.ejim.2007.06.026","article-title":"Venous thromboembolism in Spain. Comparison between an administrative database and the RIETE registry","volume":"19","author":"Guijarro","year":"2008","journal-title":"Eur. J. Intern. Med."}],"container-title":["Viruses"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/1999-4915\/14\/2\/178\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,10]],"date-time":"2025-10-10T22:03:22Z","timestamp":1760133802000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/1999-4915\/14\/2\/178"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,1,18]]},"references-count":24,"journal-issue":{"issue":"2","published-online":{"date-parts":[[2022,2]]}},"alternative-id":["v14020178"],"URL":"https:\/\/doi.org\/10.3390\/v14020178","relation":{},"ISSN":["1999-4915"],"issn-type":[{"value":"1999-4915","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,1,18]]}}}