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Background incidence rates of adverse events of special interest related to COVID-19 vaccines in Ontario, Canada, 2015 to 2020, to inform COVID-19 vaccine safety surveillance
Nasreen, Sharifa
Calzavara, Andrew Buchan, Sarah A. Thampi, Nisha Johnson, Caitlin Wilson, Sarah E. Kwong, Jeffrey C.
Calzavara, Andrew
Buchan, Sarah A.
Thampi, Nisha
Johnson, Caitlin
Wilson, Sarah E.
Kwong, Jeffrey C.
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Journal Title
Vaccine
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Term and Year
Publication Date
2022-05
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Publication Volume
40
Publication Issue
24
Publication Begin
3305
Publication End
3312
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Abstract
Background: Background incidence rates are critical in pharmacovigilance to facilitate identification of vaccine safety signals. We estimated background incidence rates of 11 adverse events of special interest related to COVID-19 vaccines in Ontario, Canada.
Methods: We conducted a population-based retrospective observational study using linked health administrative databases for hospitalizations and emergency department visits among Ontario residents. We estimated incidence rates of Bell's palsy, idiopathic thrombocytopenia, febrile convulsions, acute disseminated encephalomyelitis, myocarditis, pericarditis, Kawasaki disease, Guillain-Barré syndrome, transverse myelitis, acute myocardial infarction, and anaphylaxis during five pre-pandemic years (2015-2019) and 2020.
Results: The average annual population was 14 million across all age groups with 51% female. The pre-pandemic mean annual rates per 100,000 population during 2015-2019 were 191 for acute myocardial infarction, 43.9 for idiopathic thrombocytopenia, 28.8 for anaphylaxis, 27.8 for Bell's palsy, 25.0 for febrile convulsions, 22.8 for acute disseminated encephalomyelitis, 11.3 for myocarditis/pericarditis, 8.7 for pericarditis, 2.9 for myocarditis, 2.0 for Kawasaki disease, 1.9 for Guillain-Barré syndrome, and 1.7 for transverse myelitis. Females had higher rates of acute disseminated encephalomyelitis, transverse myelitis and anaphylaxis while males had higher rates of myocarditis, pericarditis, and Guillain-Barré syndrome. Bell's palsy, acute disseminated encephalomyelitis, and Guillain-Barré syndrome increased with age. The mean rates of myocarditis and/or pericarditis increased with age up to 79 years; males had higher rates than females: from 12 to 59 years for myocarditis and ≥12 years for pericarditis. Febrile convulsions and Kawasaki disease were predominantly childhood diseases and generally decreased with age.
Conclusions: Our estimated background rates will permit estimating numbers of expected events for these conditions and facilitate detection of potential safety signals following COVID-19 vaccination.
Citation
Nasreen S, Calzavara A, Buchan SA, Thampi N, Johnson C, Wilson SE, Kwong JC; Canadian Immunization Research Network (CIRN) Provincial Collaborative Network (PCN) Ontario investigators. Background incidence rates of adverse events of special interest related to COVID-19 vaccines in Ontario, Canada, 2015 to 2020, to inform COVID-19 vaccine safety surveillance. Vaccine. 2022 May 26;40(24):3305-3312. doi: 10.1016/j.vaccine.2022.04.065. Epub 2022 Apr 27. PMID: 35527057; PMCID: PMC9042732.