Background With large-scale COVID-19 vaccination implemented world-wide, safety signals needing rapid evaluation will emerge. We report population-based, age- and-sex-specific background incidence rates of conditions representing potential vaccine adverse events of special interest (AESI) for the Swedish general population using register data. Methods We studied an age/sex-stratified random 10% sample of the Swedish population on 1 Jan 2020, followed for AESI outcomes during 1 year, as the COVID-19 pandemic emerged and developed, before the start of vaccinations. We selected and defined the following outcomes based on information from regulatory authorities, large-scale adverse events initiatives and previous studies: aseptic meningitis, febrile seizure, Kawasaki syndrome, MISC, post-infectious arthritis, arthritis, myocarditis, ARDS, myocardial infarction, stroke, ischemic stroke, hemorrhagic stroke, venous thromboembolism, pulmonary embolism, kidney failure, liver failure, erythema multiforme, disseminated intravascular coagulation, autoimmune thyroiditis, and appendicitis. We calculated incidence rates stratified by age, sex and time period (quarters of 2020), and classified them using Council of International Organizations of Medical Sciences (CIOMS) categories: very common, common, uncommon, rare, or very rare. Results We included 972,723 study subjects, representing the Swedish national population on 1 Jan 2020. We found that AESI incidence rates vary greatly by age and in some cases sex. Several common AESIs showed expected increase with age, while some (e.g. appendicitis, aseptic meningitis, autoimmune thyroiditis, Kawasaki syndrome and MISC) were more common in young people, and others exhibited a flatter age pattern (e.g. myocarditis, DIC and erythema multiforme). Consequently, the CIOMS classification for AESIs varied widely according to age. Considerable variability was suggested for some AESI rates across the 4 quarters of 2020, potentially related to pandemic waves, seasonal variation, healthcare system overload or other healthcare delivery effects. Conclusion Age, sex, and timing of rates are important to consider when background AESI rates are compared to corresponding rates observed with COVID-19 vaccines.
Competing Interest Statement
Dr. Nyberg reports prior employment at AstraZeneca until 2019, and ownership of some AstraZeneca shares. Dr. Vanfleteren reports grants and personal fees from AstraZeneca, personal fees from Novartis, GSK, Chiesi, Menarini, Pulmonx, Resmed, Boehringer, Verona Pharma, AGA Linde AstraZeneca (DSMB) outside the submitted work. Dr. Sundström reports ownership in companies providing services to Itrim, Amgen, Janssen, Novo Nordisk, Eli Lilly, Boehringer, Bayer, Pfizer and AstraZeneca, outside the submitted work. Dr. Gisslén reports personal fees (DSMB) from AstraZeneca, personal fees from Gilead, personal fees from GSK/ViiV, personal fees from MSD, other from Gilead, other from GSK/ViiV, personal fees from Biogen, personal fees from Novocure, personal fees from Amgen, personal fees from Novo Nordisk, outside the submitted work. Dr. Lindh, Dr. Santosa, Dr. Wettermark, Dr. Hammar and Mr Kirui have nothing to disclose.
This vaccination research has received funding from Knut och Alice Wallenbergs Stiftelse / SciLifeLab (KAW 2021.0010), and the Swedish Research Council (2021-05045, 2021-05450). The underlying SCIFI-PEARL study is currently financed by a grants from the Swedish state under the agreement between the Swedish government and the county councils, the ALF-agreement (Avtal om Läkarutbildning och Forskning / Medical Training and Research Agreement) grant ALFGBG-938453 and from FORMAS (Forskningsrådet för miljö, areella näringar och samhällsbyggande / Research Council for Environment, Agricultural Sciences and Spatial Planning), a government research council for sustainable development, grant 2020-02828.
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Paper in collection COVID-19 SARS-CoV-2 preprints from medRxiv and bioRxiv
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