| アブストラクト | BACKGROUND: Adverse events of special interest (AESIs) were pre-specified to be monitored for the COVID-19 vaccines. Some AESIs are not only associated with the vaccines, but with COVID-19. Our aim was to characterise the incidence rates of AESIs following SARS-CoV-2 infection in patients and compare these to historical rates in the general population. METHODS: A multi-national cohort study with data from primary care, electronic health records, and insurance claims mapped to a common data model. This study's evidence was collected between Jan 1, 2017 and the conclusion of each database (which ranged from Jul 2020 to May 2022). The 16 pre-specified prevalent AESIs were: acute myocardial infarction, anaphylaxis, appendicitis, Bell's palsy, deep vein thrombosis, disseminated intravascular coagulation, encephalomyelitis, Guillain- Barre syndrome, haemorrhagic stroke, non-haemorrhagic stroke, immune thrombocytopenia, myocarditis/pericarditis, narcolepsy, pulmonary embolism, transverse myelitis, and thrombosis with thrombocytopenia. Age-sex standardised incidence rate ratios (SIR) were estimated to compare post-COVID-19 to pre-pandemic rates in each of the databases. FINDINGS: Substantial heterogeneity by age was seen for AESI rates, with some clearly increasing with age but others following the opposite trend. Similarly, differences were also observed across databases for same health outcome and age-sex strata. All studied AESIs appeared consistently more common in the post-COVID-19 compared to the historical cohorts, with related meta-analytic SIRs ranging from 1.32 (1.05 to 1.66) for narcolepsy to 11.70 (10.10 to 13.70) for pulmonary embolism. INTERPRETATION: Our findings suggest all AESIs are more common after COVID-19 than in the general population. Thromboembolic events were particularly common, and over 10-fold more so. More research is needed to contextualise post-COVID-19 complications in the longer term. FUNDING: None. |
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| 投稿者 | Voss, Erica A; Shoaibi, Azza; Yin Hui Lai, Lana; Blacketer, Clair; Alshammari, Thamir; Makadia, Rupa; Haynes, Kevin; Sena, Anthony G; Rao, Gowtham; van Sandijk, Sebastiaan; Fraboulet, Clement; Boyer, Laurent; Le Carrour, Tanguy; Horban, Scott; Morales, Daniel R; Martinez Roldan, Jordi; Ramirez-Anguita, Juan Manuel; Mayer, Miguel A; de Wilde, Marcel; John, Luis H; Duarte-Salles, Talita; Roel, Elena; Pistillo, Andrea; Kolde, Raivo; Maljkovic, Filip; Denaxas, Spiros; Papez, Vaclav; Kahn, Michael G; Natarajan, Karthik; Reich, Christian; Secora, Alex; Minty, Evan P; Shah, Nigam H; Posada, Jose D; Garcia Morales, Maria Teresa; Bosca, Diego; Cadenas Juanino, Honorio; Diaz Holgado, Antonio; Pedrera Jimenez, Miguel; Serrano Balazote, Pablo; Garcia Barrio, Noelia; Sen, Selcuk; Uresin, Ali Yagiz; Erdogan, Baris; Belmans, Luc; Byttebier, Geert; Malbrain, Manu L N G; Dedman, Daniel J; Cuccu, Zara; Vashisht, Rohit; Butte, Atul J; Patel, Ayan; Dahm, Lisa; Han, Cora; Bu, Fan; Arshad, Faaizah; Ostropolets, Anna; Nyberg, Fredrik; Hripcsak, George; Suchard, Marc A; Prieto-Alhambra, Dani; Rijnbeek, Peter R; Schuemie, Martijn J; Ryan, Patrick B |
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| 組織名 | OHDSI Collaborators, Observational Health Data Sciences and Informatics (OHDSI),;New York, NY, USA.;Department of Medical Informatics, Erasmus University Medical Center, Rotterdam,;the Netherlands.;Janssen Pharmaceutical Research and Development LLC, Titusville, NJ, USA.;Department of Informatics, Imaging & Data Sciences, University of Manchester,;Manchester, UK.;College of Pharmacy, Prince Sattam Bin Abdulaziz University, Alkharj, Kingdom of;Saudi Arabia.;Odysseus Data Services, Prague, Czechia.;Department of Medical Information, Assistance Publique - Hopitaux de Marseille,;Marseille, France.;Easter Eggs, Paris, France.;Health Informatics Centre, University of Dundee, Dundee, UK.;Division of Population Health and Genomics, University of Dundee, Dundee, UK.;Department of Public Health, University of Southern Denmark, Odense, Denmark.;Hospital del Mar, Department of Innovation and Digital Transformation, Barcelona,;Spain.;Hospital del Mar Medical Research Institute (IMIM), Barcelona, Spain.;Department of Medicine and Life Sciences, Universitat Pompeu Fabra, Barcelona,;Fundacio Institut Universitari per a la Recerca a l'Atencio Primaria de Salut;Jordi Gol I Gurina (IDIAPJGol), Barcelona, Spain.;University of Tartu, Tartu, Estonia.;Heliant, Belgrade, Serbia.;University College London, Institute of Health Informatics, London, UK.;Health Data Research UK, London, UK.;British Heart Foundation Data Science Centre, London, UK.;University of Colorado Anschutz Medical Campus, Denver, CO, USA.;Department of Biomedical Informatics, Columbia University Irving Medical Center,;New York-Presbyterian Hospital, New York, NY, USA.;IQVIA, Falls Church, VA, USA.;O'Brien Institute for Public Health, Faculty of Medicine, University of Calgary,;Alberta, CA, USA.;Stanford School of Medicine, Stanford University, Palo Alto, CA, USA.;Department of Systems Engineering, School of Engineering, Universidad del Norte,;Barranquilla, Colombia.;Instituto de Investigacion, Hospital 12 de Octubre, Madrid, Spain.;VeraTech for Health, Valencia, Spain.;Fundacion para la Investigacion e Innovacion Biosanitaria en Atencion Primaria;(FIIBAP), Madrid, Spain.;Hospital Universitario 12 de Octubre, Madrid, Spain.;Division of Clinical Pharmacology, Department of Medical Pharmacology, Istanbul;Faculty of Medicine, Istanbul University, Istanbul, Turkiye.;Clinerion, Basel, Switzerland.;Medaman BV, Geel, Flanders, Belgium.;1st Department Anaesthesiology and Intensive Therapy, Professor Critical Care;Research, Medical University Lublin, Lublin, Poland.;Clinical Practice Research Datalink, Medicines and Healthcare Products Regulatory;Agency, London, UK.;Bakar Computational Health Sciences Institute, University of California San;Francisco, San Francisco, CA, USA.;Center for Data-driven Insights and Innovation, University of California Health,;Oakland, CA, USA.;Department of Biostatistics, University of California, Los Angeles, Los Angeles,;CA, USA.;School of Public Health and Community Medicine, Institute of Medicine,;Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.;VA Informatics and Computing Infrastructure, US Department of Veterans Affairs,;Salt Lake City, UT, USA.;Centre for Statistics in Medicine, NDORMS, University of Oxford, Oxford, UK. |
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