Contextualising adverse events of special interest to characterise the baseline incidence rates in 24 million patients with COVID-19 across 26 databases: a multinational retrospective cohort study
Year: 2023
Type: article
Study design: Observational Study
Abstract: 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- Barré 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.
Source: EClinicalMedicine
Authors: Erica A. Voss, Azza Shoaibi, Lana Yin Hui Lai, Clair Blacketer, Thamir Alshammari, Rupa Makadia, Kevin Haynes, Anthony G. Sena, Gowtham Rao, Sebastiaan van Sandijk, Clement Fraboulet, Laurent Boyer, Tanguy Le Carrour, Scott Horban, Daniel R. Morales, Jordi Martínez Roldán, Juan Manuel Ramírez-Anguita, Miguel A. Mayer, Marcel de Wilde, Luis H. John, Talita Duarte-Salles, Elena Roel, Andrea Pistillo, Raivo Kolde, Filip Maljković, Spiros Denaxas, Vaclav Papez, Michael G. Kahn, Karthik Natarajan, Christian Reich, Alex Secora, Evan P. Minty, Nigam H. Shah, Jose D. Posada, Maria Teresa Garcia Morales, Diego Bosca, Honorio Cadenas Juanino, Antonio Diaz Holgado, Miguel Pedrera Jiménez, Pablo Serrano Balazote, Noelia García Barrio, Selçuk Şen, Ali Yağız Üresin, Baris Erdogan, Luc Belmans, Geert Byttebier, Manu L.N.G. Malbrain, Daniel J. Dedman, Zara Cuccu, Rohit Vashisht, Atul J. Butte, Ayan Patel, Lisa Dahm, Cora Han, Fan Bu, Faaizah Arshad, Anna Ostropolets, Fredrik Nyberg, George Hripcsak, Marc A. Suchard, Dani Prieto-Alhambra, Peter R. Rijnbeek, Martijn J. Schuemie, Patrick B. Ryan
Institutions: United States Department of Veterans Affairs, Erasmus MC, Janssen Research & Development (United States), University of California, San Francisco, University of Oxford, University of Manchester, Fundación para la Investigación e Innovación Biosanitaria de Atención Primaria, Prince Sattam Bin Abdulaziz University, University of California, Los Angeles, Istanbul University-Cerrahpaşa, Istanbul University, Universidad del Norte, Research Institute Hospital 12 de Octubre, Assistance Publique Hôpitaux de Marseille, Hospital Universitario 12 De Octubre, University of Dundee, University of Southern Denmark, University of Gothenburg, Hospital Del Mar, Universitat Pompeu Fabra, Municipal Institute for Medical Research, Hospital del Mar Research Institute, Institut Universitari d'Investigació en Atenció Primària Jordi Gol, University of Tartu, Health Data Research UK, University College London, Clinical Practice Research Datalink, Medicines and Healthcare products Regulatory Agency, University of Colorado Anschutz, University of Colorado Denver, NewYork–Presbyterian Hospital, Columbia University Irving Medical Center, IQVIA (United States), University of Calgary, O'Brien Institute for Public Health, Stanford Medicine, Stanford University, Medical University of Lublin, University of California System
Language: English
Subfield: Infectious Diseases
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $5,000
OpenAlex ID: W4362633643