COVID-19 vaccine safety in Scotland - background rates of adverse events of special interest

Cullen, L.A. and Grange, Z. and Antal, K. and Waugh, L. and Alsina, M.S. and Gibbons, C.L. and MacDonald, L.E. and Robertson, C. and Cameron, J.C. and Stockton, D. and O'Leary, M.C. (2023) COVID-19 vaccine safety in Scotland - background rates of adverse events of special interest. Public Health, 224. pp. 1-7. ISSN 1476-5616 (

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Objectives: Mass COVID-19 vaccination commenced in December 2020 in Scotland. Monitoring vaccine safety relies on accurate background incidence rates (IRs) for health outcomes potentially associated with vaccination. This study aimed to quantify IRs in Scotland of adverse events of special interest (AESI) potentially associated with COVID-19 vaccination. Study design and methods: IRs and 95% confidence intervals (CIs) for 36 AESI were calculated retrospectively for the pre-COVID-19 pandemic period (01 January 2015–31 December 2019) and the COVID-19 pandemic period (01 April 2020–30 November 2020), with age-sex stratification, and separately by calendar month and year. Incident cases were determined using International Classification of Diseases-10th Revision (ICD-10)–coded hospitalisations. Results: Prepandemic population-wide IRs ranged from 0.4 (0.3–0.5 CIs) cases per 100,000 person-years (PYRS) for neuromyelitis optica to 478.4 (475.8–481.0 CIs) cases per 100,000 PYRS for acute renal failure. Pandemic population-wide IRs ranged from 0.3 (0.2–0.5 CIs) cases per 100,000 PYRS for Kawasaki disease to 483.4 (473.2–493.7 CIs) cases per 100,000 PYRS for acute coronary syndrome. All AESI IRs varied by age and sex. Ten AESI (acute coronary syndrome, acute myocardial infarction, angina pectoris, heart failure, multiple sclerosis, polyneuropathies and peripheral neuropathies, respiratory failure, rheumatoid arthritis and polyarthritis, seizures and vasculitis) had lower pandemic than prepandemic period IRs overall. Only deep vein thrombosis and pulmonary embolism had a higher pandemic IR. Conclusion: Lower pandemic IRs likely resulted from reduced health-seeking behaviours and healthcare provision. Higher IRs may be associated with SARS-CoV-2 infections. AESI IRs will facilitate future vaccine safety studies in Scotland.