@article{RN354,
   author = {Li, X. and Ostropolets, A. and Makadia, R. and Shaoibi, A. and Rao, G. and Sena, A. G. and Martinez-Hernandez, E. and Delmestri, A. and Verhamme, K. and Rijnbeek, P. R. and Duarte-Salles, T. and Suchard, M. and Ryan, P. and Hripcsak, G. and Prieto-Alhambra, D.},
   title = {Characterizing the incidence of adverse events of special interest for COVID-19 vaccines across eight countries: a multinational network cohort study},
   journal = {medRxiv},
   note = {Li, Xintong Ostropolets, Anna Makadia, Rupa Shaoibi, Azza Rao, Gowtham Sena, Anthony G Martinez-Hernandez, Eugenia Delmestri, Antonella Verhamme, Katia Rijnbeek, Peter R Duarte-Salles, Talita Suchard, Marc Ryan, Patrick Hripcsak, George Prieto-Alhambra, Daniel R01 LM006910/LM/NLM NIH HHS/United States Preprint United States 2021/04/02 medRxiv. 2021 Apr 17:2021.03.25.21254315. doi: 10.1101/2021.03.25.21254315. Preprint.},
   abstract = {BACKGROUND: As large-scale immunization programs against COVID-19 proceed around the world, safety signals will emerge that need rapid evaluation. We report population-based, age- and sex-specific background incidence rates of potential adverse events of special interest (AESI) in eight countries using thirteen databases. METHODS: This multi-national network cohort study included eight electronic medical record and five administrative claims databases from Australia, France, Germany, Japan, Netherlands, Spain, the United Kingdom, and the United States, mapped to a common data model. People observed for at least 365 days before 1 January 2017, 2018, or 2019 were included. We based study outcomes on lists published by regulators: acute myocardial infarction, anaphylaxis, appendicitis, Bell's palsy, deep vein thrombosis, disseminated intravascular coagulation, encephalomyelitis, Guillain-Barre syndrome, hemorrhagic and non-hemorrhagic stroke, immune thrombocytopenia, myocarditis/pericarditis, narcolepsy, pulmonary embolism, and transverse myelitis. We calculated incidence rates stratified by age, sex, and database. We pooled rates across databases using random effects meta-analyses. We classified meta-analytic estimates into Council of International Organizations of Medical Sciences categories: very common, common, uncommon, rare, or very rare. FINDINGS: We analysed 126,661,070 people. Rates varied greatly between databases and by age and sex. Some AESI (e.g., myocardial infarction, Guillain-Barre syndrome) increased with age, while others (e.g., anaphylaxis, appendicitis) were more common in young people. As a result, AESI were classified differently according to age. For example, myocardial infarction was very rare in children, rare in women aged 35-54 years, uncommon in men and women aged 55-84 years, and common in those aged ≥85 years. INTERPRETATION: We report robust baseline rates of prioritised AESI across 13 databases. Age, sex, and variation between databases should be considered if background AESI rates are compared to event rates observed with COVID-19 vaccines. , DOI = 10.1101/2021.03.25.21254315},
   year = {2021},
   type = {Journal Article}
}

{"_id":"rMfXeZyPQmRRkGaxk","bibbaseid":"li-ostropolets-makadia-shaoibi-rao-sena-martinezhernandez-delmestri-etal-characterizingtheincidenceofadverseeventsofspecialinterestforcovid19vaccinesacrosseightcountriesamultinationalnetworkcohortstudy-2021","author_short":["Li, X.","Ostropolets, A.","Makadia, R.","Shaoibi, A.","Rao, G.","Sena, A. G.","Martinez-Hernandez, E.","Delmestri, A.","Verhamme, K.","Rijnbeek, P. R.","Duarte-Salles, T.","Suchard, M.","Ryan, P.","Hripcsak, G.","Prieto-Alhambra, D."],"bibdata":{"bibtype":"article","type":"Journal Article","author":[{"propositions":[],"lastnames":["Li"],"firstnames":["X."],"suffixes":[]},{"propositions":[],"lastnames":["Ostropolets"],"firstnames":["A."],"suffixes":[]},{"propositions":[],"lastnames":["Makadia"],"firstnames":["R."],"suffixes":[]},{"propositions":[],"lastnames":["Shaoibi"],"firstnames":["A."],"suffixes":[]},{"propositions":[],"lastnames":["Rao"],"firstnames":["G."],"suffixes":[]},{"propositions":[],"lastnames":["Sena"],"firstnames":["A.","G."],"suffixes":[]},{"propositions":[],"lastnames":["Martinez-Hernandez"],"firstnames":["E."],"suffixes":[]},{"propositions":[],"lastnames":["Delmestri"],"firstnames":["A."],"suffixes":[]},{"propositions":[],"lastnames":["Verhamme"],"firstnames":["K."],"suffixes":[]},{"propositions":[],"lastnames":["Rijnbeek"],"firstnames":["P.","R."],"suffixes":[]},{"propositions":[],"lastnames":["Duarte-Salles"],"firstnames":["T."],"suffixes":[]},{"propositions":[],"lastnames":["Suchard"],"firstnames":["M."],"suffixes":[]},{"propositions":[],"lastnames":["Ryan"],"firstnames":["P."],"suffixes":[]},{"propositions":[],"lastnames":["Hripcsak"],"firstnames":["G."],"suffixes":[]},{"propositions":[],"lastnames":["Prieto-Alhambra"],"firstnames":["D."],"suffixes":[]}],"title":"Characterizing the incidence of adverse events of special interest for COVID-19 vaccines across eight countries: a multinational network cohort study","journal":"medRxiv","note":"Li, Xintong Ostropolets, Anna Makadia, Rupa Shaoibi, Azza Rao, Gowtham Sena, Anthony G Martinez-Hernandez, Eugenia Delmestri, Antonella Verhamme, Katia Rijnbeek, Peter R Duarte-Salles, Talita Suchard, Marc Ryan, Patrick Hripcsak, George Prieto-Alhambra, Daniel R01 LM006910/LM/NLM NIH HHS/United States Preprint United States 2021/04/02 medRxiv. 2021 Apr 17:2021.03.25.21254315. doi: 10.1101/2021.03.25.21254315. Preprint.","abstract":"BACKGROUND: As large-scale immunization programs against COVID-19 proceed around the world, safety signals will emerge that need rapid evaluation. We report population-based, age- and sex-specific background incidence rates of potential adverse events of special interest (AESI) in eight countries using thirteen databases. METHODS: This multi-national network cohort study included eight electronic medical record and five administrative claims databases from Australia, France, Germany, Japan, Netherlands, Spain, the United Kingdom, and the United States, mapped to a common data model. People observed for at least 365 days before 1 January 2017, 2018, or 2019 were included. We based study outcomes on lists published by regulators: acute myocardial infarction, anaphylaxis, appendicitis, Bell's palsy, deep vein thrombosis, disseminated intravascular coagulation, encephalomyelitis, Guillain-Barre syndrome, hemorrhagic and non-hemorrhagic stroke, immune thrombocytopenia, myocarditis/pericarditis, narcolepsy, pulmonary embolism, and transverse myelitis. We calculated incidence rates stratified by age, sex, and database. We pooled rates across databases using random effects meta-analyses. We classified meta-analytic estimates into Council of International Organizations of Medical Sciences categories: very common, common, uncommon, rare, or very rare. FINDINGS: We analysed 126,661,070 people. Rates varied greatly between databases and by age and sex. Some AESI (e.g., myocardial infarction, Guillain-Barre syndrome) increased with age, while others (e.g., anaphylaxis, appendicitis) were more common in young people. As a result, AESI were classified differently according to age. For example, myocardial infarction was very rare in children, rare in women aged 35-54 years, uncommon in men and women aged 55-84 years, and common in those aged ≥85 years. INTERPRETATION: We report robust baseline rates of prioritised AESI across 13 databases. Age, sex, and variation between databases should be considered if background AESI rates are compared to event rates observed with COVID-19 vaccines. , DOI = 10.1101/2021.03.25.21254315","year":"2021","bibtex":"@article{RN354,\r\n author = {Li, X. and Ostropolets, A. and Makadia, R. and Shaoibi, A. and Rao, G. and Sena, A. G. and Martinez-Hernandez, E. and Delmestri, A. and Verhamme, K. and Rijnbeek, P. R. and Duarte-Salles, T. and Suchard, M. and Ryan, P. and Hripcsak, G. and Prieto-Alhambra, D.},\r\n title = {Characterizing the incidence of adverse events of special interest for COVID-19 vaccines across eight countries: a multinational network cohort study},\r\n journal = {medRxiv},\r\n note = {Li, Xintong Ostropolets, Anna Makadia, Rupa Shaoibi, Azza Rao, Gowtham Sena, Anthony G Martinez-Hernandez, Eugenia Delmestri, Antonella Verhamme, Katia Rijnbeek, Peter R Duarte-Salles, Talita Suchard, Marc Ryan, Patrick Hripcsak, George Prieto-Alhambra, Daniel R01 LM006910/LM/NLM NIH HHS/United States Preprint United States 2021/04/02 medRxiv. 2021 Apr 17:2021.03.25.21254315. doi: 10.1101/2021.03.25.21254315. Preprint.},\r\n abstract = {BACKGROUND: As large-scale immunization programs against COVID-19 proceed around the world, safety signals will emerge that need rapid evaluation. We report population-based, age- and sex-specific background incidence rates of potential adverse events of special interest (AESI) in eight countries using thirteen databases. METHODS: This multi-national network cohort study included eight electronic medical record and five administrative claims databases from Australia, France, Germany, Japan, Netherlands, Spain, the United Kingdom, and the United States, mapped to a common data model. People observed for at least 365 days before 1 January 2017, 2018, or 2019 were included. We based study outcomes on lists published by regulators: acute myocardial infarction, anaphylaxis, appendicitis, Bell's palsy, deep vein thrombosis, disseminated intravascular coagulation, encephalomyelitis, Guillain-Barre syndrome, hemorrhagic and non-hemorrhagic stroke, immune thrombocytopenia, myocarditis/pericarditis, narcolepsy, pulmonary embolism, and transverse myelitis. We calculated incidence rates stratified by age, sex, and database. We pooled rates across databases using random effects meta-analyses. We classified meta-analytic estimates into Council of International Organizations of Medical Sciences categories: very common, common, uncommon, rare, or very rare. FINDINGS: We analysed 126,661,070 people. Rates varied greatly between databases and by age and sex. Some AESI (e.g., myocardial infarction, Guillain-Barre syndrome) increased with age, while others (e.g., anaphylaxis, appendicitis) were more common in young people. As a result, AESI were classified differently according to age. For example, myocardial infarction was very rare in children, rare in women aged 35-54 years, uncommon in men and women aged 55-84 years, and common in those aged ≥85 years. INTERPRETATION: We report robust baseline rates of prioritised AESI across 13 databases. Age, sex, and variation between databases should be considered if background AESI rates are compared to event rates observed with COVID-19 vaccines. , DOI = 10.1101/2021.03.25.21254315},\r\n year = {2021},\r\n type = {Journal Article}\r\n}\r\n\r\n","author_short":["Li, X.","Ostropolets, A.","Makadia, R.","Shaoibi, A.","Rao, G.","Sena, A. G.","Martinez-Hernandez, E.","Delmestri, A.","Verhamme, K.","Rijnbeek, P. R.","Duarte-Salles, T.","Suchard, M.","Ryan, P.","Hripcsak, G.","Prieto-Alhambra, D."],"key":"RN354","id":"RN354","bibbaseid":"li-ostropolets-makadia-shaoibi-rao-sena-martinezhernandez-delmestri-etal-characterizingtheincidenceofadverseeventsofspecialinterestforcovid19vaccinesacrosseightcountriesamultinationalnetworkcohortstudy-2021","role":"author","urls":{},"metadata":{"authorlinks":{}},"html":""},"bibtype":"article","biburl":"https://bibbase.org/network/files/qwipow2DJsAxqNp83","dataSources":["PJSqX8FMpCPRdw3CQ","qLDnCcKM9omXNrRY8","TB9sD3avjy7bNxfgS","vDmJPYmHEKAT3tMNL","PcZMFHooKwpboi2he","jZMXEeHTfokmisJDv"],"keywords":[],"search_terms":["characterizing","incidence","adverse","events","special","interest","covid","vaccines","eight","countries","multinational","network","cohort","study","li","ostropolets","makadia","shaoibi","rao","sena","martinez-hernandez","delmestri","verhamme","rijnbeek","duarte-salles","suchard","ryan","hripcsak","prieto-alhambra"],"title":"Characterizing the incidence of adverse events of special interest for COVID-19 vaccines across eight countries: a multinational network cohort study","year":2021}