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Characterising the background incidence rates of adverse events of special interest for covid-19 vaccines in eight countries: multinational network cohort study

Xintong Li; Anna Ostropolets; Rupa Makadia; Azza Shoaibi; Gowtham Rao; Anthony G Sena; Eugenia Martinez-Hernandez; Antonella Delmestri; Katia Verhamme; Peter R Rijnbeek; Talita Duarte-Salles; Marc A Suchard; Patrick B Ryan; George Hripcsak; Daniel Prieto-Alhambra

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      <creatorName>Xintong Li</creatorName>
      <creatorName>Anna Ostropolets</creatorName>
      <creatorName>Rupa Makadia</creatorName>
      <creatorName>Azza Shoaibi</creatorName>
      <creatorName>Gowtham Rao</creatorName>
      <creatorName>Anthony G Sena</creatorName>
      <creatorName>Eugenia Martinez-Hernandez</creatorName>
      <creatorName>Antonella Delmestri</creatorName>
      <creatorName>Katia Verhamme</creatorName>
      <creatorName>Peter R Rijnbeek</creatorName>
      <creatorName>Talita Duarte-Salles</creatorName>
      <creatorName>Marc A Suchard</creatorName>
      <creatorName>Patrick B Ryan</creatorName>
      <creatorName>George Hripcsak</creatorName>
      <creatorName>Daniel Prieto-Alhambra</creatorName>
    <title>Characterising the background incidence rates of adverse events of special interest for covid-19 vaccines in eight countries: multinational network cohort study</title>
    <subject>adverse events</subject>
    <date dateType="Issued">2021-06-03</date>
  <resourceType resourceTypeGeneral="JournalArticle"/>
    <alternateIdentifier alternateIdentifierType="url"></alternateIdentifier>
    <relatedIdentifier relatedIdentifierType="DOI" relationType="IsIdenticalTo">10.1136/bmj.n1435</relatedIdentifier>
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    <rights rightsURI="">Creative Commons Attribution 4.0 International</rights>
    <rights rightsURI="info:eu-repo/semantics/openAccess">Open Access</rights>
    <description descriptionType="Abstract">&lt;p&gt;&lt;strong&gt;Objective&lt;/strong&gt; - To quantify the background incidence rates of 15 prespecified adverse events of special interest (AESIs) associated with covid-19 vaccines.&lt;/p&gt;

&lt;p&gt;&lt;strong&gt;Design - &lt;/strong&gt;Multinational network cohort study.&lt;/p&gt;

&lt;p&gt;&lt;strong&gt;Setting&lt;/strong&gt; - Electronic health records and health claims data from eight countries: Australia, France, Germany, Japan, the Netherlands, Spain, the United Kingdom, and the United States, mapped to a common data model.&lt;/p&gt;

&lt;p&gt;&lt;strong&gt;Participants&lt;/strong&gt; - 126 661 070 people observed for at least 365 days before 1 January 2017, 2018, or 2019 from 13 databases.&lt;/p&gt;

&lt;p&gt;&lt;strong&gt;Main outcome measures&lt;/strong&gt; - Events of interests were 15 prespecified AESIs (non-haemorrhagic and haemorrhagic stroke, acute myocardial infarction, deep vein thrombosis, pulmonary embolism, anaphylaxis, Bell&amp;rsquo;s palsy, myocarditis or pericarditis, narcolepsy, appendicitis, immune thrombocytopenia, disseminated intravascular coagulation, encephalomyelitis (including acute disseminated encephalomyelitis), Guillain-Barr&amp;eacute; syndrome, and transverse myelitis). Incidence rates of AESIs were stratified by age, sex, and database. Rates were pooled across databases using random effects meta-analyses and classified according to the frequency categories of the Council for International Organizations of Medical Sciences.&lt;/p&gt;

&lt;p&gt;&lt;strong&gt;Results&lt;/strong&gt; - Background rates varied greatly between databases. Deep vein thrombosis ranged from 387 (95% confidence interval 370 to 404) per 100 000 person years in UK CPRD GOLD data to 1443 (1416 to 1470) per 100 000 person years in US IBM MarketScan Multi-State Medicaid data among women aged 65 to 74 years. Some AESIs increased with age. For example, myocardial infarction rates in men increased from 28 (27 to 29) per 100 000 person years among those aged 18-34 years to 1400 (1374 to 1427) per 100 000 person years in those older than 85 years in US Optum electronic health record data. Other AESIs were more common in young people. For example, rates of anaphylaxis among boys and men were 78 (75 to 80) per 100 000 person years in those aged 6-17 years and 8 (6 to 10) per 100 000 person years in those older than 85 years in Optum electronic health record data. Meta-analytic estimates of AESI rates were classified according to age and sex.&lt;/p&gt;

&lt;p&gt;&lt;strong&gt;Conclusion&lt;/strong&gt; - This study found large variations in the observed rates of AESIs by age group and sex, showing the need for stratification or standardisation before using background rates for safety surveillance. Considerable population level heterogeneity in AESI rates was found between databases.&lt;/p&gt;</description>
      <funderName>European Commission</funderName>
      <funderIdentifier funderIdentifierType="Crossref Funder ID">10.13039/501100000780</funderIdentifier>
      <awardNumber awardURI="info:eu-repo/grantAgreement/EC/H2020/806968/">806968</awardNumber>
      <awardTitle>European Health Data and Evidence Network</awardTitle>
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