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<div class="social-share hide" data-share-journal="JAMA_current" data-share-title="Myocarditis Cases Reported After mRNA-Based COVID-19 Vaccination in the US From December 2020 to August 2021"></div>
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<div class="figure-label">Figure 1. Cases of Myocarditis After mRNA-Based COVID-19 Vaccination by Age at Onset of Myocarditis</div><a id="joi210145f1" class="figure-table-anchor"> </a>
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<p class="para">The reports to the Vaccine Adverse Event Reporting System met the case definition of myocarditis (reported cases). Among individuals older than 40 years of age, there were no more than 8 reports of myocarditis for
any individual age after receiving either vaccine. For the BNT162b2 vaccine, there were 114 246 837 first vaccination doses and 95 532 396 second vaccination doses; and for the mRNA-1273 vaccine, there were 78 158 611 and
66 163 001, respectively. The y-axis range differs between panels A and B.</p>
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<div class="figure-label">Figure 2. Cases of Myocarditis After mRNA-Based COVID-19 Vaccination by Time From Vaccination to Symptom Onset</div><a id="joi210145f2" class="figure-table-anchor"> </a>
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<p class="para">The reports to the Vaccine Adverse Event Reporting System met the case definition of myocarditis (reported cases). Among recipients of either vaccine, there were only 13 reports or less of myocarditis beyond 10
days for any individual time from vaccination to symptom onset. The y-axis range differs between panels A and B.</p>
<p class="para">A, For the BNT162b2 vaccine, there were 138 reported cases of myocarditis with known date for symptom onset and dose after 114 246 837 first vaccination doses and 888 reported cases after 95 532 396 second
vaccination doses.</p>
<p class="para">B, For the mRNA-1273 vaccine, there were 116 reported cases of myocarditis with known date for symptom onset and dose after 78 158 611 first vaccination doses and 311 reported cases after 66 163 001 second
vaccination doses.</p>
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<div class="table-label">Table 1. Characteristics of Reports to VAERS After mRNA-Based COVID-19 Vaccination That Met the CDC’s Case Definition for Myocarditis Between December 14, 2020, and August 31, 2021</div>
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<div class="table-label">Table 2. Reports to VAERS After mRNA-Based COVID-19 Vaccination That Met the CDC’s Case Definition for Myocarditis Within a 7-Day Risk Interval per Million Doses of Vaccine Administered</div>
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<div class="table-label">Table 3. Symptoms, Treatment, and Outcomes in 826 Patients Younger Than 30 Years of Age With Myocarditis</div><a class="figure-table-anchor" id="joi210145t3"> </a>
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<div class="supplement-title"><span class="title-label">Supplement.</span><p class="para"><strong>eMethods.</strong> Medical Dictionary for Regulatory Activities Preferred Terms, Definitions of Myocarditis and Pericarditis, Myocarditis medical review form</p><p class="para"><strong>eFigure.</strong> Flow diagram of cases of myocarditis and pericarditis reported to Vaccine Adverse Event Reporting System (VAERS) after receiving mRNA-based COVID-19 vaccine, United States, December 14, 2020-August 31, 2021.</p><p class="para"><strong>eTable 1.</strong> Characteristics of all myocarditis cases reported to Vaccine Adverse Event Reporting System (VAERS) after mRNA-based COVID-19 vaccination, United States, December 14, 2020–August 31, 2021.</p><p class="para"><strong>eTable 2.</strong> Characteristics of all pericarditis cases reported to Vaccine Adverse Event Reporting System (VAERS) after mRNA-based COVID-19 vaccination, United States, December 14, 2020–August 31, 2021.</p><p class="para"><strong>eTable 3.</strong> Characteristics of myocarditis cases reported to Vaccine Adverse Event Reporting System after mRNA-based COVID-19 vaccination by case definition status.</p></div>
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<p class="get-citation-citation">Oster ME, Shay DK, Su JR, et al. Myocarditis Cases Reported After mRNA-Based COVID-19 Vaccination in the US From December 2020 to August 2021. <em>JAMA.</em> 2022;327(4):331–340.
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<span class="hide tagmanagervalue" data-attribute="articleDOI" data-value="10.1001/jama.2021.24110" data-type="string"></span>
<span class="hide tagmanagervalue" data-attribute="articleTitle" data-value="Myocarditis Cases Reported After mRNA-Based COVID-19 Vaccination in the US From December 2020 to August 2021" data-type="string"></span>
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<div class="meta-date"><span class="ppub"><span class="month">January </span><span class="day">25, </span><span class="year">2022</span></span></div>
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<h1 class="meta-article-title ">Myocarditis Cases Reported After mRNA-Based COVID-19 Vaccination in the US From December 2020 to August 2021</h1>
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class="wi-fullname brand-fg"><a href="/searchresults?author=Matthew+E.+Oster&q=Matthew+E.+Oster" rel="nofollow" target="_blank">Matthew E. Oster, MD, MPH<sup>1,2,3</sup></a></span><span class="al-author-delim">;
</span><span class="wi-fullname brand-fg"><a href="/searchresults?author=David+K.+Shay&q=David+K.+Shay" rel="nofollow" target="_blank">David K. Shay, MD, MPH<sup>1</sup></a></span><span class="al-author-delim">;
</span><span class="wi-fullname brand-fg"><a href="/searchresults?author=John+R.+Su&q=John+R.+Su" rel="nofollow" target="_blank">John R. Su, MD, PhD, MPH<sup>1</sup></a></span>;
<a class="meta-authors--etal td-u">et al</a></span>
<span class="meta-authors--remaining"><span class="wi-fullname brand-fg"><a href="/searchresults?author=Julianne+Gee&q=Julianne+Gee" rel="nofollow" target="_blank">Julianne Gee, MPH<sup>1</sup></a></span><span
class="al-author-delim">; </span><span
class="wi-fullname brand-fg"><a href="/searchresults?author=C.+Buddy+Creech&q=C.+Buddy+Creech" rel="nofollow" target="_blank">C. Buddy Creech, MD, MPH<sup>4</sup></a></span><span class="al-author-delim">;
</span><span class="wi-fullname brand-fg"><a href="/searchresults?author=Karen+R.+Broder&q=Karen+R.+Broder" rel="nofollow" target="_blank">Karen R. Broder, MD<sup>1</sup></a></span><span class="al-author-delim">;
</span><span class="wi-fullname brand-fg"><a href="/searchresults?author=Kathryn+Edwards&q=Kathryn+Edwards" rel="nofollow" target="_blank">Kathryn Edwards, MD<sup>4</sup></a></span><span class="al-author-delim">;
</span><span class="wi-fullname brand-fg"><a href="/searchresults?author=Jonathan+H.+Soslow&q=Jonathan+H.+Soslow" rel="nofollow" target="_blank">Jonathan H. Soslow, MD, MSCI<sup>4</sup></a></span><span
class="al-author-delim">; </span><span class="wi-fullname brand-fg"><a href="/searchresults?author=Jeffrey+M.+Dendy&q=Jeffrey+M.+Dendy" rel="nofollow" target="_blank">Jeffrey M. Dendy, MD<sup>4</sup></a></span><span
class="al-author-delim">; </span><span
class="wi-fullname brand-fg"><a href="/searchresults?author=Elizabeth+Schlaudecker&q=Elizabeth+Schlaudecker" rel="nofollow" target="_blank">Elizabeth Schlaudecker, MD, MPH<sup>5</sup></a></span><span
class="al-author-delim">; </span><span class="wi-fullname brand-fg"><a href="/searchresults?author=Sean+M.+Lang&q=Sean+M.+Lang" rel="nofollow" target="_blank">Sean M. Lang, MD<sup>5</sup></a></span><span
class="al-author-delim">; </span><span
class="wi-fullname brand-fg"><a href="/searchresults?author=Elizabeth+D.+Barnett&q=Elizabeth+D.+Barnett" rel="nofollow" target="_blank">Elizabeth D. Barnett, MD<sup>6</sup></a></span><span class="al-author-delim">;
</span><span class="wi-fullname brand-fg"><a href="/searchresults?author=Frederick+L.+Ruberg&q=Frederick+L.+Ruberg" rel="nofollow" target="_blank">Frederick L. Ruberg, MD<sup>6</sup></a></span><span
class="al-author-delim">; </span><span
class="wi-fullname brand-fg"><a href="/searchresults?author=Michael+J.+Smith&q=Michael+J.+Smith" rel="nofollow" target="_blank">Michael J. Smith, MD, MSCE<sup>7</sup></a></span><span class="al-author-delim">;
</span><span class="wi-fullname brand-fg"><a href="/searchresults?author=M.+Jay+Campbell&q=M.+Jay+Campbell" rel="nofollow" target="_blank">M. Jay Campbell, MD, MHA<sup>7</sup></a></span><span class="al-author-delim">;
</span><span class="wi-fullname brand-fg"><a href="/searchresults?author=Renato+D.+Lopes&q=Renato+D.+Lopes" rel="nofollow" target="_blank">Renato D. Lopes, MD, PhD, MHS<sup>7</sup></a></span><span
class="al-author-delim">; </span><span
class="wi-fullname brand-fg"><a href="/searchresults?author=Laurence+S.+Sperling&q=Laurence+S.+Sperling" rel="nofollow" target="_blank">Laurence S. Sperling, MD<sup>1,2</sup></a></span><span class="al-author-delim">;
</span><span class="wi-fullname brand-fg"><a href="/searchresults?author=Jane+A.+Baumblatt&q=Jane+A.+Baumblatt" rel="nofollow" target="_blank">Jane A. Baumblatt, MD<sup>8</sup></a></span><span class="al-author-delim">;
</span><span class="wi-fullname brand-fg"><a href="/searchresults?author=Deborah+L.+Thompson&q=Deborah+L.+Thompson" rel="nofollow" target="_blank">Deborah L. Thompson, MD, MSPH<sup>8</sup></a></span><span
class="al-author-delim">; </span><span
class="wi-fullname brand-fg"><a href="/searchresults?author=Paige+L.+Marquez&q=Paige+L.+Marquez" rel="nofollow" target="_blank">Paige L. Marquez, MSPH<sup>1</sup></a></span><span class="al-author-delim">;
</span><span class="wi-fullname brand-fg"><a href="/searchresults?author=Penelope+Strid&q=Penelope+Strid" rel="nofollow" target="_blank">Penelope Strid, MPH<sup>1</sup></a></span><span class="al-author-delim">;
</span><span class="wi-fullname brand-fg"><a href="/searchresults?author=Jared+Woo&q=Jared+Woo" rel="nofollow" target="_blank">Jared Woo, MPH<sup>1</sup></a></span><span class="al-author-delim">; </span><span
class="wi-fullname brand-fg"><a href="/searchresults?author=River+Pugsley&q=River+Pugsley" rel="nofollow" target="_blank">River Pugsley, PhD, MPH<sup>1</sup></a></span><span class="al-author-delim">; </span><span
class="wi-fullname brand-fg"><a href="/searchresults?author=Sarah+Reagan-Steiner&q=Sarah+Reagan-Steiner" rel="nofollow" target="_blank">Sarah Reagan-Steiner, MD, MPH<sup>1</sup></a></span><span
class="al-author-delim">; </span><span
class="wi-fullname brand-fg"><a href="/searchresults?author=Frank+DeStefano&q=Frank+DeStefano" rel="nofollow" target="_blank">Frank DeStefano, MD, MPH<sup>1</sup></a></span><span class="al-author-delim">;
</span><span class="wi-fullname brand-fg"><a href="/searchresults?author=Tom+T.+Shimabukuro&q=Tom+T.+Shimabukuro" rel="nofollow" target="_blank">Tom T. Shimabukuro, MD, MPH, MBA<sup>1</sup></a></span></span>
</div>
<div class="meta-author">
<a class="meta-author-title is-b" data-tog-target=".meta-author-content">Author Affiliations</a>
<a class="meta-articleinfo-jumplink section-jump-link scroll-to target-exists" data-tab-toggle=".tab-nav-full-text" href="#248198305">Article Information</a>
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<div class="meta-author-name"><sup>1</sup>US Centers for Disease Control and Prevention, Atlanta, Georgia</div>
</li>
<li class="meta-author-affiliation">
<div class="meta-author-name"><sup>2</sup>School of Medicine, Emory University, Atlanta, Georgia</div>
</li>
<li class="meta-author-affiliation">
<div class="meta-author-name"><sup>3</sup>Children’s Healthcare of Atlanta, Atlanta, Georgia</div>
</li>
<li class="meta-author-affiliation">
<div class="meta-author-name"><sup>4</sup>Vanderbilt University Medical Center, Nashville, Tennessee</div>
</li>
<li class="meta-author-affiliation">
<div class="meta-author-name"><sup>5</sup>Cincinnati Children’s Hospital Medical Center, Cincinnati, Ohio</div>
</li>
<li class="meta-author-affiliation">
<div class="meta-author-name"><sup>6</sup>Boston Medical Center, Boston, Massachusetts</div>
</li>
<li class="meta-author-affiliation">
<div class="meta-author-name"><sup>7</sup>Duke University, Durham, North Carolina</div>
</li>
<li class="meta-author-affiliation">
<div class="meta-author-name"><sup>8</sup>US Food and Drug Administration, Silver Spring, Maryland</div>
</li>
</ul>
</div>
</div>
<div class="meta-citation-wrap">
<span class="meta-citation-journal-name">JAMA. </span><span class="meta-citation"> 2022;327(4):331-340. doi:10.1001/jama.2021.24110</span>
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<div class="related-article-title sb-tc">Myocarditis and Pericarditis After Vaccination for COVID-19</div>
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<div class="related-article-authors">George A. Diaz, MD; Guilford T. Parsons, MD, MS; Sara K. Gering, BS, BSN; Audrey R. Meier, MPH; Ian V. Hutchinson, PhD, DSc;
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<div class="related-article-authors">Jay Montgomery, MD; Margaret Ryan, MD, MPH; Renata Engler, MD; Donna Hoffman, MSN; Bruce McClenathan, MD; Limone Collins, MD;
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<span class="heading-text thm-col h3 cb section-type-keyPoints decorated-hed sb-sc ">Key Points</span>
<p><strong>Question</strong> <span>What is the risk of myocarditis after mRNA-based COVID-19 vaccination in the US?</span></p>
<p><strong>Findings</strong> <span>In this descriptive study of 1626 cases of myocarditis in a national passive reporting system, the crude reporting rates within 7 days after vaccination exceeded the expected rates across
multiple age and sex strata. The rates of myocarditis cases were highest after the second vaccination dose in adolescent males aged 12 to 15 years (70.7 per million doses of the BNT162b2 vaccine), in adolescent males aged 16 to 17
years (105.9 per million doses of the BNT162b2 vaccine), and in young men aged 18 to 24 years (52.4 and 56.3 per million doses of the BNT162b2 vaccine and the mRNA-1273 vaccine, respectively).</span></p>
<p><strong>Meaning</strong> <span>Based on passive surveillance reporting in the US, the risk of myocarditis after receiving mRNA-based COVID-19 vaccines was increased across multiple age and sex strata and was highest after the
second vaccination dose in adolescent males and young men.</span></p> <a class="article-section-id-anchor" id="248198254"></a>
<div class="h3 cb section-type-abstract decorated-hed ">
<div class="heading-text thm-col sb-sc"> Abstract </div>
</div>
<p><strong>Importance</strong> <span>Vaccination against COVID-19 provides clear public health benefits, but vaccination also carries potential risks. The risks and outcomes of myocarditis after COVID-19 vaccination are
unclear.</span></p>
<p><strong>Objective</strong> <span>To describe reports of myocarditis and the reporting rates after mRNA-based COVID-19 vaccination in the US.</span></p>
<p><strong>Design, Setting, and Participants</strong> <span>Descriptive study of reports of myocarditis to the Vaccine Adverse Event Reporting System (VAERS) that occurred after mRNA-based COVID-19 vaccine administration between
December 2020 and August 2021 in 192 405 448 individuals older than 12 years of age in the US; data were processed by VAERS as of September 30, 2021.</span></p>
<p><strong>Exposures</strong> <span>Vaccination with BNT162b2 (Pfizer-BioNTech) or mRNA-1273 (Moderna).</span></p>
<p><strong>Main Outcomes and Measures</strong> <span>Reports of myocarditis to VAERS were adjudicated and summarized for all age groups. Crude reporting rates were calculated across age and sex strata. Expected rates of
myocarditis by age and sex were calculated using 2017-2019 claims data. For persons younger than 30 years of age, medical record reviews and clinician interviews were conducted to describe clinical presentation, diagnostic test
results, treatment, and early outcomes.</span></p>
<p><strong>Results</strong> <span>Among 192 405 448 persons receiving a total of 354 100 845 mRNA-based COVID-19 vaccines during the study period, there were 1991 reports of myocarditis to VAERS and 1626 of these reports met the
case definition of myocarditis. Of those with myocarditis, the median age was 21 years (IQR, 16-31 years) and the median time to symptom onset was 2 days (IQR, 1-3 days). Males comprised 82% of the myocarditis cases for whom sex
was reported. The crude reporting rates for cases of myocarditis within 7 days after COVID-19 vaccination exceeded the expected rates of myocarditis across multiple age and sex strata. The rates of myocarditis were highest after
the second vaccination dose in adolescent males aged 12 to 15 years (70.7 per million doses of the BNT162b2 vaccine), in adolescent males aged 16 to 17 years (105.9 per million doses of the BNT162b2 vaccine), and in young men aged
18 to 24 years (52.4 and 56.3 per million doses of the BNT162b2 vaccine and the mRNA-1273 vaccine, respectively). There were 826 cases of myocarditis among those younger than 30 years of age who had detailed clinical information
available; of these cases, 792 of 809 (98%) had elevated troponin levels, 569 of 794 (72%) had abnormal electrocardiogram results, and 223 of 312 (72%) had abnormal cardiac magnetic resonance imaging results. Approximately 96% of
persons (784/813) were hospitalized and 87% (577/661) of these had resolution of presenting symptoms by hospital discharge. The most common treatment was nonsteroidal anti-inflammatory drugs (589/676; 87%).</span></p>
<p><strong>Conclusions and Relevance</strong> <span>Based on passive surveillance reporting in the US, the risk of myocarditis after receiving mRNA-based COVID-19 vaccines was increased across multiple age and sex strata and was
highest after the second vaccination dose in adolescent males and young men. This risk should be considered in the context of the benefits of COVID-19 vaccination.</span></p>
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<div class="h3 cb section-type-section ">
<div class="heading-text thm-col sb-sc"> Introduction </div>
</div>
<a class="article-section-id-anchor" id="248198260"></a>
<p class="para">Myocarditis is an inflammatory condition of the heart muscle that has a bimodal peak incidence during infancy and adolescence or young
adulthood.<sup><a href="#joi210145r1" class="ref-link section-jump-link" data-tab-toggle=".tab-nav-references">1</a></sup><sup>-<a href="#joi210145r1" class="ref-link section-jump-link" data-tab-toggle=".tab-nav-references">4</a></sup>
The clinical presentation and course of myocarditis is variable, with some patients not requiring treatment and others experiencing severe heart failure that requires subsequent heart transplantation or leads to
death.<sup><a href="#joi210145r5" class="ref-link section-jump-link" data-tab-toggle=".tab-nav-references">5</a></sup> Onset of myocarditis typically follows an inciting process, often a viral illness; however, no antecedent cause
is identified in many cases.<sup><a href="#joi210145r6" class="ref-link section-jump-link" data-tab-toggle=".tab-nav-references">6</a></sup> It has been hypothesized that vaccination can serve as a trigger for myocarditis; however,
only the smallpox vaccine has previously been causally associated with myocarditis based on reports among US military personnel, with cases typically occurring 7 to 12 days after
vaccination.<sup><a href="#joi210145r7" class="ref-link section-jump-link" data-tab-toggle=".tab-nav-references">7</a></sup></p> <a class="article-section-id-anchor" id="248198261"></a>
<p class="para">With the implementation of a large-scale, national COVID-19 vaccination program starting in December 2020, the US Centers for Disease Control and Prevention (CDC) and the US Food and Drug Administration began
monitoring for a number of adverse events of special interest, including myocarditis and pericarditis, in the Vaccine Adverse Event Reporting System (VAERS), a long-standing national spontaneous reporting (passive surveillance)
system.<sup><a href="#joi210145r8" class="ref-link section-jump-link" data-tab-toggle=".tab-nav-references">8</a></sup> As the reports of myocarditis after COVID-19 vaccination were reported to VAERS, the Clinical Immunization
Safety Assessment Project,<sup><a href="#joi210145r9" class="ref-link section-jump-link" data-tab-toggle=".tab-nav-references">9</a></sup> a collaboration between the CDC and medical research centers, which includes physicians
treating infectious diseases and other specialists (eg, cardiologists), consulted on several of the cases. In addition, reports from several countries raised concerns that mRNA-based COVID-19 vaccines may be associated with acute
myocarditis.<sup><a href="#joi210145r10" class="ref-link section-jump-link" data-tab-toggle=".tab-nav-references">10</a></sup><sup>-<a href="#joi210145r10" class="ref-link section-jump-link" data-tab-toggle=".tab-nav-references">15</a></sup>
</p> <a class="article-section-id-anchor" id="248198262"></a>
<p class="para">Given this concern, the aims were to describe reports and confirmed cases of myocarditis initially reported to VAERS after mRNA-based COVID-19 vaccination and to provide estimates of the risk of myocarditis after
mRNA-based COVID-19 vaccination based on age, sex, and vaccine type.</p> <a class="article-section-id-anchor" id="248198263"></a>
<div class="h3 cb section-type-section ">
<div class="heading-text thm-col sb-sc"> Methods </div>
</div>
<a class="article-section-id-anchor" id="248198264"></a>
<div class="h4 cb section-type-section ">
<div class="heading-text "> Data Sources </div>
</div>
<a class="article-section-id-anchor" id="248198265"></a>
<p class="para">VAERS is a US spontaneous reporting (passive surveillance) system that functions as an early warning system for potential vaccine adverse
events.<sup><a href="#joi210145r8" class="ref-link section-jump-link" data-tab-toggle=".tab-nav-references">8</a></sup> Co-administered by the CDC and the US Food and Drug Administration, VAERS accepts reports of all adverse events
after vaccination from patients, parents, clinicians, vaccine manufacturers, and others regardless of whether the events could plausibly be associated with receipt of the vaccine. Reports to VAERS include information about the
vaccinated person, the vaccine or vaccines administered, and the adverse events experienced by the vaccinated person. The reports to VAERS are then reviewed by third-party professional coders who have been trained in the assignment
of Medical Dictionary for Regulatory Activities preferred terms.<sup><a href="#joi210145r16" class="ref-link section-jump-link" data-tab-toggle=".tab-nav-references">16</a></sup> The coders then assign appropriate terms based on the
information available in the reports.</p> <a class="article-section-id-anchor" id="248198266"></a>
<p class="para">This activity was reviewed by the CDC and was conducted to be consistent with applicable federal law and CDC policy. The activities herein were confirmed to be nonresearch under the Common Rule in accordance with
institutional procedures and therefore were not subject to institutional review board requirements. Informed consent was not obtained for this secondary use of existing information; see 45 CFR part 46.102(l)(2), 21 CFR part 56, 42
USC §241(d), 5 USC §552a, and 44 USC §3501 et seq.</p> <a class="article-section-id-anchor" id="248198267"></a>
<div class="h4 cb section-type-section ">
<div class="heading-text "> Exposure </div>
</div>
<a class="article-section-id-anchor" id="248198268"></a>
<p class="para">The exposure of concern was vaccination with one of the mRNA-based COVID-19 vaccines: the BNT162b2 vaccine (Pfizer-BioNTech) or the mRNA-1273 vaccine (Moderna). During the analytic period, persons aged 12 years or
older were eligible for the BNT162b2 vaccine and persons aged 18 years or older were eligible for the mRNA-1273 vaccine. The number of COVID-19 vaccine doses administered during the analytic period was obtained through the CDC’s
COVID-19 Data Tracker.<sup><a href="#joi210145r17" class="ref-link section-jump-link" data-tab-toggle=".tab-nav-references">17</a></sup></p> <a class="article-section-id-anchor" id="248198269"></a>
<div class="h4 cb section-type-section ">
<div class="heading-text "> Outcomes </div>
</div>
<a class="article-section-id-anchor" id="248198270"></a>
<p class="para">The primary outcome was the occurrence of myocarditis and the secondary outcome was pericarditis. Reports to VAERS with these outcomes were initially characterized using the Medical Dictionary for Regulatory Activities
preferred terms of myocarditis or pericarditis (specific terms are listed in the eMethods in the <a class="supplement-link section-jump-link" data-tab-toggle=".tab-nav-supplemental" href="#note-JOI210145-1">Supplement</a>). After
initial review of reports of myocarditis to VAERS and review of the patient’s medical records (when available), the reports were further reviewed by CDC physicians and public health professionals to verify that they met the CDC’s
case definition for probable or confirmed myocarditis (descriptions previously published and included in the eMethods in the
<a class="supplement-link section-jump-link" data-tab-toggle=".tab-nav-supplemental" href="#note-JOI210145-1">Supplement</a>).<sup><a href="#joi210145r18" class="ref-link section-jump-link" data-tab-toggle=".tab-nav-references">18</a></sup>
The CDC’s case definition of probable myocarditis requires the presence of new concerning symptoms, abnormal cardiac test results, and no other identifiable cause of the symptoms and findings. Confirmed cases of myocarditis further
require histopathological confirmation of myocarditis or cardiac magnetic resonance imaging (MRI) findings consistent with myocarditis.</p> <a class="article-section-id-anchor" id="248198271"></a>
<p class="para">Deaths were included only if the individual had met the case definition for confirmed myocarditis and there was no other identifiable cause of death. Individual cases not involving death were included only if the
person had met the case definition for probable myocarditis or confirmed myocarditis.</p> <a class="article-section-id-anchor" id="248198272"></a>
<div class="h4 cb section-type-section ">
<div class="heading-text "> Statistical Analysis </div>
</div>
<a class="article-section-id-anchor" id="248198273"></a>
<p class="para">We characterized reports of myocarditis or pericarditis after COVID-19 vaccination that met the CDC’s case definition and were received by VAERS between December 14, 2020 (when COVID-19 vaccines were first publicly
available in the US), and August 31, 2021, by age, sex, race, ethnicity, and vaccine type; data were processed by VAERS as of September 30, 2021. Race and ethnicity were optional fixed categories available by self-identification at
the time of vaccination or by the individual filing a VAERS report. Race and ethnicity were included to provide the most complete baseline description possible for individual reports; however, further analyses were not stratified by
race and ethnicity due to the high percentage of missing data. Reports of pericarditis with evidence of potential myocardial involvement were included in the review of reports of myocarditis. The eFigure in the
<a class="supplement-link section-jump-link" data-tab-toggle=".tab-nav-supplemental" href="#note-JOI210145-1">Supplement</a> outlines the categorization of the reports of myocarditis and pericarditis reviewed.</p>
<a class="article-section-id-anchor" id="248198274"></a>
<p class="para">Further analyses were conducted only for myocarditis because of the preponderance of those reports to VAERS, in Clinical Immunization Safety Assessment Project consultations, and in published
articles.<sup><a href="#joi210145r10" class="ref-link section-jump-link" data-tab-toggle=".tab-nav-references">10</a></sup><sup>-<a href="#joi210145r10" class="ref-link section-jump-link" data-tab-toggle=".tab-nav-references">12</a>,<a href="#joi210145r19" class="ref-link section-jump-link" data-tab-toggle=".tab-nav-references">19</a></sup><sup>-<a href="#joi210145r19" class="ref-link section-jump-link" data-tab-toggle=".tab-nav-references">21</a></sup>
Crude reporting rates for myocarditis during a 7-day risk interval were calculated using the number of reports of myocarditis to VAERS per million doses of COVID-19 vaccine administered during the analytic period and stratified by
age, sex, vaccination dose (first, second, or unknown), and vaccine type. Expected rates of myocarditis by age and sex were calculated using 2017-2019 data from the IBM MarketScan Commercial Research Database. This database contains
individual-level, deidentified, inpatient and outpatient medical and prescription drug claims, and enrollment information submitted to IBM Watson Health by large employers and health plans. The data were accessed using version 4.0
of the IBM MarketScan Treatment Pathways analytic platform. Age- and sex-specific rates were calculated by determining the number of individuals with myocarditis
(<i>International Statistical Classification of Diseases and Related Health Problems, Tenth Revision [ICD-10]</i> codes B33.20, B33.22, B33.24, I40.0, I40.1, I40.8, I40.9, or
I51.4)<sup><a href="#joi210145r22" class="ref-link section-jump-link" data-tab-toggle=".tab-nav-references">22</a></sup> identified during an inpatient encounter in 2017-2019 relative to the number of individuals of similar age and
sex who were continually enrolled during the year in which the myocarditis-related hospitalization occurred; individuals with any diagnosis of myocarditis prior to that year were excluded. Given the limitations of the IBM MarketScan
Commercial Research Database to capture enrollees aged 65 years or older, an expected rate for myocarditis was not calculated for this population. A 95% CI was calculated using Poisson distribution in SAS version 9.4 (SAS Institute
Inc) for each expected rate of myocarditis and for each observed rate in a strata with at least 1 case.</p> <a class="article-section-id-anchor" id="248198275"></a>
<p class="para">In cases of probable or confirmed myocarditis among those younger than 30 years of age, their clinical course was then summarized to the extent possible based on medical review and clinician interviews. This clinical
course included presenting symptoms, diagnostic test results, treatment, and early outcomes (abstraction form appears in the eMethods in the
<a class="supplement-link section-jump-link" data-tab-toggle=".tab-nav-supplemental" href="#note-JOI210145-1">Supplement</a>).<sup><a href="#joi210145r23" class="ref-link section-jump-link" data-tab-toggle=".tab-nav-references">23</a></sup>
</p> <a class="article-section-id-anchor" id="248198276"></a>
<p class="para">When applicable, missing data were delineated in the results or the numbers with complete data were listed. No assumptions or imputations were made regarding missing data. Any percentages that were calculated included
only those cases of myocarditis with adequate data to calculate the percentages.</p> <a class="article-section-id-anchor" id="248198277"></a>
<div class="h3 cb section-type-section ">
<div class="heading-text thm-col sb-sc"> Results </div>
</div>
<a class="article-section-id-anchor" id="248198278"></a>
<div class="h4 cb section-type-section ">
<div class="heading-text "> Case Characteristics </div>
</div>
<a class="article-section-id-anchor" id="248198279"></a>
<p class="para">Between December 14, 2020, and August 31, 2021, 192 405 448 individuals older than 12 years of age received a total of 354 100 845 mRNA-based COVID-19 vaccines. VAERS received 1991 reports of myocarditis (391 of which
also included pericarditis) after receipt of at least 1 dose of mRNA-based COVID-19 vaccine (eTable 1 in the
<a class="supplement-link section-jump-link" data-tab-toggle=".tab-nav-supplemental" href="#note-JOI210145-1">Supplement</a>) and 684 reports of pericarditis without the presence of myocarditis (eTable 2 in the
<a class="supplement-link section-jump-link" data-tab-toggle=".tab-nav-supplemental" href="#note-JOI210145-1">Supplement</a>).</p> <a class="article-section-id-anchor" id="248198280"></a>
<p class="para">Of the 1991 reports of myocarditis, 1626 met the CDC’s case definition for probable or confirmed myocarditis
(<a href="#joi210145t1" class="table-link section-jump-link" data-tab-toggle=".tab-nav-figure-table">Table 1</a>). There were 208 reports that did not meet the CDC’s case definition for myocarditis and 157 reports that required more
information to perform adjudication (eTable 3 in the <a class="supplement-link section-jump-link" data-tab-toggle=".tab-nav-supplemental" href="#note-JOI210145-1">Supplement</a>). Of the 1626 reports that met the CDC’s case
definition for myocarditis, 1195 (73%) were younger than 30 years of age, 543 (33%) were younger than 18 years of age, and the median age was 21 years (IQR, 16-31 years)
(<a href="#joi210145f1" class="figure-link section-jump-link" data-tab-toggle=".tab-nav-figure-table">Figure 1</a>). Of the reports of myocarditis with dose information, 82% (1265/1538) occurred after the second vaccination dose. Of
those with a reported dose and time to symptom onset, the median time from vaccination to symptom onset was 3 days (IQR, 1-8 days) after the first vaccination dose and 74% (187/254) of myocarditis events occurred within 7 days.
After the second vaccination dose, the median time to symptom onset was 2 days (IQR, 1-3 days) and 90% (1081/1199) of myocarditis events occurred within 7 days
(<a href="#joi210145f2" class="figure-link section-jump-link" data-tab-toggle=".tab-nav-figure-table">Figure 2</a>).</p> <a class="article-section-id-anchor" id="248198284"></a>
<p class="para">Males comprised 82% (1334/1625) of the cases of myocarditis for whom sex was reported. The largest proportions of cases of myocarditis were among White persons (non-Hispanic or ethnicity not reported; 69% [914/1330])
and Hispanic persons (of all races; 17% [228/1330]). Among persons younger than 30 years of age, there were no confirmed cases of myocarditis in those who died after mRNA-based COVID-19 vaccination without another identifiable cause
and there was 1 probable case of myocarditis but there was insufficient information available for a thorough investigation. At the time of data review, there were 2 reports of death in persons younger than 30 years of age with
potential myocarditis that remain under investigation and are not included in the case counts.</p> <a class="article-section-id-anchor" id="248198285"></a>
<div class="h4 cb section-type-section ">
<div class="heading-text "> Reporting Rates of Myocarditis Within 7 Days After COVID-19 Vaccination </div>
</div>
<a class="article-section-id-anchor" id="248198286"></a>
<p class="para">Symptom onset of myocarditis was within 7 days after vaccination for 947 reports of individuals who received the BNT162b2 vaccine and for 382 reports of individuals who received the mRNA-1273 vaccine. The rates of
myocarditis varied by vaccine type, sex, age, and first or second vaccination dose (<a href="#joi210145t2" class="table-link section-jump-link" data-tab-toggle=".tab-nav-figure-table">Table 2</a>). The reporting rates of myocarditis
were highest after the second vaccination dose in adolescent males aged 12 to 15 years (70.73 [95% CI, 61.68-81.11] per million doses of the BNT162b2 vaccine), in adolescent males aged 16 to 17 years (105.86 [95% CI, 91.65-122.27]
per million doses of the BNT162b2 vaccine), and in young men aged 18 to 24 years (52.43 [95% CI, 45.56-60.33] per million doses of the BNT162b2 vaccine and 56.31 [95% CI, 47.08-67.34] per million doses of the mRNA-1273 vaccine). The
lower estimate of the 95% CI for reporting rates of myocarditis in adolescent males and young men exceeded the upper bound of the expected rates after the first vaccination dose with the BNT162b2 vaccine in those aged 12 to 24
years, after the second vaccination dose with the BNT162b2 vaccine in those aged 12 to 49 years, after the first vaccination dose with the mRNA-1273 vaccine in those aged 18 to 39 years, and after the second vaccination dose with
the mRNA-1273 vaccine in those aged 18 to 49 years.</p> <a class="article-section-id-anchor" id="248198288"></a>
<p class="para">The reporting rates of myocarditis in females were lower than those in males across all age strata younger than 50 years of age. The reporting rates of myocarditis were highest after the second vaccination dose in
adolescent females aged 12 to 15 years (6.35 [95% CI, 4.05-9.96] per million doses of the BNT162b2 vaccine), in adolescent females aged 16 to 17 years (10.98 [95% CI, 7.16-16.84] per million doses of the BNT162b2 vaccine), in young
women aged 18 to 24 years (6.87 [95% CI, 4.27-11.05] per million doses of the mRNA-1273 vaccine), and in women aged 25 to 29 years (8.22 [95% CI, 5.03-13.41] per million doses of the mRNA-1273 vaccine). The lower estimate of the 95%
CI for reporting rates of myocarditis in females exceeded the upper bound of the expected rates after the second vaccination dose with the BNT162b2 vaccine in those aged 12 to 29 years and after the second vaccination dose with the
mRNA-1273 vaccine in those aged 18 to 29 years.</p> <a class="article-section-id-anchor" id="248198289"></a>
<div class="h4 cb section-type-section ">
<div class="heading-text "> Clinical Course of Myocarditis After COVID-19 Vaccination in Persons Younger Than 30 Years of Age </div>
</div>
<a class="article-section-id-anchor" id="248198290"></a>
<p class="para">Among the 1372 reports of myocarditis in persons younger than 30 years of age, 1305 were able to be adjudicated, with 92% (1195/1305) meeting the CDC’s case definition. Of these, chart abstractions or medical
interviews were completed for 69% (826/1195) (<a href="#joi210145t3" class="table-link section-jump-link" data-tab-toggle=".tab-nav-figure-table">Table 3</a>). The symptoms commonly reported in the verified cases of myocarditis in
persons younger than 30 years of age included chest pain, pressure, or discomfort (727/817; 89%) and dyspnea or shortness of breath (242/817; 30%). Troponin levels were elevated in 98% (792/809) of the cases of myocarditis. The
electrocardiogram result was abnormal in 72% (569/794) of cases of myocarditis. Of the patients who had received a cardiac MRI, 72% (223/312) had abnormal findings consistent with myocarditis. The echocardiogram results were
available for 721 cases of myocarditis; of these, 84 (12%) demonstrated a notable decreased left ventricular ejection fraction (<50%). Among the 676 cases for whom treatment data were available, 589 (87%) received nonsteroidal
anti-inflammatory drugs. Intravenous immunoglobulin and glucocorticoids were each used in 12% of the cases of myocarditis (78/676 and 81/676, respectively). Intensive therapies such as vasoactive medications (12 cases of
myocarditis) and intubation or mechanical ventilation (2 cases) were rare. There were no verified cases of myocarditis requiring a heart transplant, extracorporeal membrane oxygenation, or a ventricular assist device. Of the 96%
(784/813) of cases of myocarditis who were hospitalized, 98% (747/762) were discharged from the hospital at time of review. In 87% (577/661) of discharged cases of myocarditis, there was resolution of the presenting symptoms by
hospital discharge.</p> <a class="article-section-id-anchor" id="248198292"></a>
<div class="h3 cb section-type-section ">
<div class="heading-text thm-col sb-sc"> Discussion </div>
</div>
<a class="article-section-id-anchor" id="248198293"></a>
<p class="para">In this review of reports to VAERS between December 2020 and August 2021, myocarditis was identified as a rare but serious adverse event that can occur after mRNA-based COVID-19 vaccination, particularly in adolescent
males and young men. However, this increased risk must be weighed against the benefits of COVID-19 vaccination.<sup><a href="#joi210145r18" class="ref-link section-jump-link" data-tab-toggle=".tab-nav-references">18</a></sup></p>
<a class="article-section-id-anchor" id="248198294"></a>
<p class="para">Compared with cases of non–vaccine-associated myocarditis, the reports of myocarditis to VAERS after mRNA-based COVID-19 vaccination were similar in demographic characteristics but different in their acute clinical
course. First, the greater frequency noted among vaccine recipients aged 12 to 29 years vs those aged 30 years or older was similar to the age distribution seen in typical cases of
myocarditis.<sup><a href="#joi210145r2" class="ref-link section-jump-link" data-tab-toggle=".tab-nav-references">2</a></sup><sup>,<a href="#joi210145r4" class="ref-link section-jump-link" data-tab-toggle=".tab-nav-references">4</a></sup>
This pattern may explain why cases of myocarditis were not discovered until months after initial Emergency Use Authorization of the vaccines in the US (ie, until the vaccines were widely available to younger persons). Second, the
sex distribution in cases of myocarditis after COVID-19 vaccination was similar to that seen in typical cases of myocarditis; there is a strong male predominance for both
conditions.<sup><a href="#joi210145r2" class="ref-link section-jump-link" data-tab-toggle=".tab-nav-references">2</a></sup><sup>,<a href="#joi210145r4" class="ref-link section-jump-link" data-tab-toggle=".tab-nav-references">4</a></sup>
</p> <a class="article-section-id-anchor" id="248198295"></a>
<p class="para">However, the onset of myocarditis symptoms after exposure to a potential immunological trigger was shorter for COVID-19 vaccine–associated cases of myocarditis than is typical for myocarditis cases diagnosed after a
viral
illness.<sup><a href="#joi210145r24" class="ref-link section-jump-link" data-tab-toggle=".tab-nav-references">24</a></sup><sup>-<a href="#joi210145r24" class="ref-link section-jump-link" data-tab-toggle=".tab-nav-references">26</a></sup>
Cases of myocarditis reported after COVID-19 vaccination were typically diagnosed within days of vaccination, whereas cases of typical viral myocarditis can often have indolent courses with symptoms sometimes present for weeks to
months after a trigger if the cause is ever identified.<sup><a href="#joi210145r1" class="ref-link section-jump-link" data-tab-toggle=".tab-nav-references">1</a></sup> The major presenting symptoms appeared to resolve faster in
cases of myocarditis after COVID-19 vaccination than in typical viral cases of myocarditis. Even though almost all individuals with cases of myocarditis were hospitalized and clinically monitored, they typically experienced
symptomatic recovery after receiving only pain management. In contrast, typical viral cases of myocarditis can have a more variable clinical course. For example, up to 6% of typical viral myocarditis cases in adolescents require a
heart transplant or result in mortality.<sup><a href="#joi210145r27" class="ref-link section-jump-link" data-tab-toggle=".tab-nav-references">27</a></sup></p> <a class="article-section-id-anchor" id="248198296"></a>
<p class="para">In the current study, the initial evaluation and treatment of COVID-19 vaccine–associated myocarditis cases was similar to that of typical myocarditis
cases.<sup><a href="#joi210145r28" class="ref-link section-jump-link" data-tab-toggle=".tab-nav-references">28</a></sup><sup>-<a href="#joi210145r28" class="ref-link section-jump-link" data-tab-toggle=".tab-nav-references">31</a></sup>
Initial evaluation usually included measurement of troponin level, electrocardiography, and echocardiography.<sup><a href="#joi210145r1" class="ref-link section-jump-link" data-tab-toggle=".tab-nav-references">1</a></sup> Cardiac
MRI was often used for diagnostic purposes and also for possible prognostic
purposes.<sup><a href="#joi210145r32" class="ref-link section-jump-link" data-tab-toggle=".tab-nav-references">32</a></sup><sup>,<a href="#joi210145r33" class="ref-link section-jump-link" data-tab-toggle=".tab-nav-references">33</a></sup>
Supportive care was a mainstay of treatment, with specific cardiac or intensive care therapies as indicated by the patient’s clinical status.</p> <a class="article-section-id-anchor" id="248198297"></a>
<p class="para">Long-term outcome data are not yet available for COVID-19 vaccine–associated myocarditis cases. The CDC has started active follow-up surveillance in adolescents and young adults to assess the health and functional
status and cardiac outcomes at 3 to 6 months in probable and confirmed cases of myocarditis reported to VAERS after COVID-19
vaccination.<sup><a href="#joi210145r34" class="ref-link section-jump-link" data-tab-toggle=".tab-nav-references">34</a></sup> For patients with myocarditis, the American Heart Association and the American College of Cardiology
guidelines advise that patients should be instructed to refrain from competitive sports for 3 to 6 months, and that documentation of a normal electrocardiogram result, ambulatory rhythm monitoring, and an exercise test should be
obtained prior to resumption of sports.<sup><a href="#joi210145r35" class="ref-link section-jump-link" data-tab-toggle=".tab-nav-references">35</a></sup> The use of cardiac MRI is unclear, but it may be useful in evaluating the
progression or resolution of myocarditis in those with abnormalities on the baseline cardiac MRI.<sup><a href="#joi210145r36" class="ref-link section-jump-link" data-tab-toggle=".tab-nav-references">36</a></sup> Further doses of
mRNA-based COVID-19 vaccines should be deferred, but may be considered in select circumstances.<sup><a href="#joi210145r37" class="ref-link section-jump-link" data-tab-toggle=".tab-nav-references">37</a></sup></p>
<a class="article-section-id-anchor" id="248198298"></a>
<div class="h4 cb section-type-section ">
<div class="heading-text "> Limitations </div>
</div>
<a class="article-section-id-anchor" id="248198299"></a>
<p class="para">This study has several limitations. First, although clinicians are required to report serious adverse events after COVID-19 vaccination, including all events leading to hospitalization, VAERS is a passive reporting
system. As such, the reports of myocarditis to VAERS may be incomplete, and the quality of the information reported is variable. Missing data for sex, vaccination dose number, and race and ethnicity were not uncommon in the reports
received; history of prior SARS-CoV-2 infection also was not known. Furthermore, as a passive system, VAERS data are subject to reporting biases in that both underreporting and overreporting are
possible.<sup><a href="#joi210145r38" class="ref-link section-jump-link" data-tab-toggle=".tab-nav-references">38</a></sup> Given the high verification rate of reports of myocarditis to VAERS after mRNA-based COVID-19 vaccination,
underreporting is more likely. Therefore, the actual rates of myocarditis per million doses of vaccine are likely higher than estimated.</p> <a class="article-section-id-anchor" id="248198300"></a>
<p class="para">Second, efforts by CDC investigators to obtain medical records or interview physicians were not always successful despite the special allowance for sharing information with the CDC under the Health Insurance
Portability and Accountability Act of 1996.<sup><a href="#joi210145r39" class="ref-link section-jump-link" data-tab-toggle=".tab-nav-references">39</a></sup> This challenge limited the ability to perform case adjudication and
complete investigations for some reports of myocarditis, although efforts are still ongoing when feasible.</p> <a class="article-section-id-anchor" id="248198301"></a>
<p class="para">Third, the data from vaccination administration were limited to what is reported to the CDC and thus may be incomplete, particularly with regard to demographics.</p>
<a class="article-section-id-anchor" id="248198302"></a>
<p class="para">Fourth, calculation of expected rates from the IBM MarketScan Commercial Research Database relied on administrative data via the use of <i>ICD-10</i> codes and there was no opportunity for clinical review. Furthermore,
these data had limited information regarding the Medicare population; thus expected rates for those older than 65 years of age were not calculated. However, it is expected that the rates in those older than 65 years of age would not
be higher than the rates in those aged 50 to 64 years.<sup><a href="#joi210145r4" class="ref-link section-jump-link" data-tab-toggle=".tab-nav-references">4</a></sup></p> <a class="article-section-id-anchor" id="248198303"></a>
<div class="h3 cb section-type-section ">
<div class="heading-text thm-col sb-sc"> Conclusions </div>
</div>
<a class="article-section-id-anchor" id="248198304"></a>
<p class="para">Based on passive surveillance reporting in the US, the risk of myocarditis after receiving mRNA-based COVID-19 vaccines was increased across multiple age and sex strata and was highest after the second vaccination dose
in adolescent males and young men. This risk should be considered in the context of the benefits of COVID-19 vaccination.</p> <a class="article-section-id-anchor" id="248198305"></a>
<div class="h3 cb section-type-acknowledgements has-back-to-top">
<a href="#top" class="section-jump-link back-to-top" data-tab-toggle=".tab-nav-full-text">Back to top</a>
<div class="heading-text thm-col sb-sc"> Article Information </div>
</div>
<p class="authorInfoSection"><strong>Corresponding Author:</strong> Matthew E. Oster, MD, MPH, US Centers for Disease Control and Prevention, 1600 Clifton Rd, Atlanta, GA 30333
(<a href="mailto:eocevent416@cdc.gov" target="_blank">eocevent416@cdc.gov</a>).</p>
<p class="para"><strong>Accepted for Publication:</strong> December 16, 2021.</p>
<p class="paraauthor-contributions"><strong>Author Contributions:</strong> Drs Oster and Su had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
</p>
<p class="para"><i>Concept and design:</i> Oster, Shay, Su, Creech, Edwards, Dendy, Schlaudecker, Woo, Shimabukuro.</p>
<p class="para"><i>Acquisition, analysis, or interpretation of data:</i> Oster, Shay, Su, Gee, Creech, Broder, Edwards, Soslow, Schlaudecker, Lang, Barnett, Ruberg, Smith, Campbell, Lopes, Sperling, Baumblatt, Thompson, Marquez,
Strid, Woo, Pugsley, Reagan-Steiner, DeStefano, Shimabukuro.</p>
<p class="para"><i>Drafting of the manuscript:</i> Oster, Shay, Su, Gee, Creech, Marquez, Strid, Woo, Shimabukuro.</p>
<p class="para"><i>Critical revision of the manuscript for important intellectual content: </i>Oster, Shay, Su, Creech, Broder, Edwards, Soslow, Dendy, Schlaudecker, Lang, Barnett, Ruberg, Smith, Campbell, Lopes, Sperling, Baumblatt,
Thompson, Pugsley, Reagan-Steiner, DeStefano, Shimabukuro.</p>
<p class="para"><i>Statistical analysis:</i> Oster, Su, Marquez, Strid, Woo, Shimabukuro.</p>
<p class="para"><i>Obtained funding:</i> Edwards, DeStefano.</p>
<p class="para"><i>Administrative, technical, or material support:</i> Oster, Gee, Creech, Broder, Edwards, Soslow, Schlaudecker, Smith, Baumblatt, Thompson, Reagan-Steiner, DeStefano.</p>
<p class="para"><i>Supervision:</i> Su, Edwards, Soslow, Dendy, Schlaudecker, Campbell, Sperling, DeStefano, Shimabukuro.</p>
<p class="parafinancial-disclosure"><strong>Conflict of Interest Disclosures:</strong> Dr Creech reported receiving grants from the National Institutes of Health for the Moderna and Janssen clinical trials and receiving personal fees
from Astellas and Horizon. Dr Edwards reported receiving grants from the National Institutes of Health; receiving personal fees from BioNet, IBM, X-4 Pharma, Seqirus, Roche, Pfizer, Merck, Moderna, and Sanofi; and receiving
compensation for being the associate editor of <i>Clinical Infectious Diseases</i>. Dr Soslow reported receiving personal fees from Esperare. Dr Schlaudecker reported receiving grants from Pfizer and receiving personal fees from
Sanofi Pasteur. Drs Barnett, Ruberg, and Smith reported receiving grants from Pfizer. Dr Lopes reported receiving personal fees from Bayer, Boehringer Ingleheim, Bristol Myers Squibb, Daiichi Sankyo, GlaxoSmithKline, Medtronic,
Merck, Pfizer, Portola, and Sanofi and receiving grants from Bristol Myers Squibb, GlaxoSmithKline, Medtronic, Pfizer, and Sanofi. No other disclosures were reported.</p>
<p class="parafunding-statement"><strong>Funding/Support:</strong> This work was supported by contracts 200-2012-53709 (Boston Medical Center), 200-2012-53661 (Cincinnati Children’s Hospital Medical Center), 200-2012-53663 (Duke
University), and 200-2012-50430 (Vanderbilt University Medical Center) with the US Centers for Disease Control and Prevention (CDC) Clinical Immunization Safety Assessment Project.</p>
<p class="para"><strong>Role of the Funder/Sponsor:</strong> The CDC provided funding via the Clinical Immunization Safety Assessment Project to Drs Creech, Edwards, Soslow, Dendy, Schlaudecker, Lang, Barnett, Ruberg, Smith, Campbell,
and Lopes. The authors affiliated with the CDC along with the other coauthors conducted the investigations; performed collection, management, analysis, and interpretation of the data; were involved in the preparation, review, and
approval of the manuscript; and made the decision to submit the manuscript for publication.</p>
<p class="para"><strong>Disclaimer:</strong> The findings and conclusions in this article are those of the authors and do not necessarily represent the official position of the CDC or the US Food and Drug Administration. Mention of a
product or company name is for identification purposes only and does not constitute endorsement by the CDC or the US Food and Drug Administration.</p>
<p class="para"><strong>Additional Contributions:</strong> We thank the following CDC staff who contributed to this article without compensation outside their normal salaries (in alphabetical order and contribution specified in
parenthesis at end of each list of names): Nickolas Agathis, MD, MPH, Stephen R. Benoit, MD, MPH, Beau B. Bruce, MD, PhD, Abigail L. Carlson, MD, MPH, Meredith G. Dixon, MD, Jonathan Duffy, MD, MPH, Charles Duke, MD, MPH, Charles
Edge, MSN, MS, Robyn Neblett Fanfair, MD, MPH, Nathan W. Furukawa, MD, MPH, Gavin Grant, MD, MPH, Grace Marx, MD, MPH, Maureen J. Miller, MD, MPH, Pedro Moro, MD, MPH, Meredith Oakley, DVM, MPH, Kia Padgett, MPH, BSN, RN, Janice
Perez-Padilla, MPH, BSN, RN, Robert Perry, MD, MPH, Nimia Reyes, MD, MPH, Ernest E. Smith, MD, MPH&TM, David Sniadack, MD, MPH, Pamela Tucker, MD, Edward C. Weiss, MD, MPH, Erin Whitehouse, PhD, MPH, RN, Pascale M. Wortley, MD,
MPH, and Rachael Zacks, MD (for clinical investigations and interviews); Amelia Jazwa, MSPH, Tara Johnson, MPH, MS, and Jamila Shields, MPH (for project coordination); Charles Licata, PhD, and Bicheng Zhang, MS (for data acquisition
and organization); Charles E. Rose, PhD (for statistical consultation); and Scott D. Grosse, PhD (for calculation of expected rates of myocarditis). We also thank the clinical staff who cared for these patients and reported the
adverse events to the Vaccine Adverse Event Reporting System.</p> <a class="article-section-id-anchor" id="248198306"></a>
<div class="h3 cb section-type-references ">
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Myocarditis Cases Reported After mRNA-Based COVID-19 Vaccination in the US From December 2020 to August 2021 | Cardiology | JAMA | JAMA Network Our website uses cookies to enhance your experience. By continuing to use our site, or clicking "Continue," you are agreeing to our Cookie Policy | Continue [Skip to Navigation] JAMA HomeNew OnlineCurrent IssueFor Authors PODCASTS Clinical Reviews Editors' Summary Medical News Author Interviews More PUBLICATIONS JAMA JAMA Network Open JAMA Cardiology JAMA Dermatology JAMA Health Forum JAMA Internal Medicine JAMA Neurology JAMA Oncology JAMA Ophthalmology JAMA Otolaryngology–Head & Neck Surgery JAMA Pediatrics JAMA Psychiatry JAMA Surgery Archives of Neurology & Psychiatry (1919-1959) JN Learning / CMESubscribeAppsJobsInstitutions / LibrariansReprints & Permissions Terms of Use | Privacy Policy | Accessibility Statement 2022 American Medical Association. All Rights Reserved Search All * Search All * JAMA * JAMA Network Open * JAMA Cardiology * JAMA Dermatology * JAMA Forum Archive * JAMA Health Forum * JAMA Internal Medicine * JAMA Neurology * JAMA Oncology * JAMA Ophthalmology * JAMA Otolaryngology–Head & Neck Surgery * JAMA Pediatrics * JAMA Psychiatry * JAMA Surgery * Archives of Neurology & Psychiatry Search All JAMA JAMA Network Open JAMA Cardiology JAMA Dermatology JAMA Forum Archive JAMA Health Forum JAMA Internal Medicine JAMA Neurology JAMA Oncology JAMA Ophthalmology JAMA Otolaryngology–Head & Neck Surgery JAMA Pediatrics JAMA Psychiatry JAMA Surgery Archives of Neurology & Psychiatry Input Search Term Sign In Individual Sign In Sign inCreate an Account Access through your institution Sign In Purchase Options: Subscribe to the JAMA journal full text icon Full Text contents icon Contents figure icon Figures / Tables multimedia icon Multimedia attach icon Supplemental Content references icon References related icon Related comments icon Comments Download PDF Top of Article * Key Points * Abstract * Introduction * Methods * Results * Discussion * Conclusions * Article Information * References Figure 1. Cases of Myocarditis After mRNA-Based COVID-19 Vaccination by Age at Onset of Myocarditis View LargeDownload The reports to the Vaccine Adverse Event Reporting System met the case definition of myocarditis (reported cases). Among individuals older than 40 years of age, there were no more than 8 reports of myocarditis for any individual age after receiving either vaccine. For the BNT162b2 vaccine, there were 114 246 837 first vaccination doses and 95 532 396 second vaccination doses; and for the mRNA-1273 vaccine, there were 78 158 611 and 66 163 001, respectively. The y-axis range differs between panels A and B. Figure 2. Cases of Myocarditis After mRNA-Based COVID-19 Vaccination by Time From Vaccination to Symptom Onset View LargeDownload The reports to the Vaccine Adverse Event Reporting System met the case definition of myocarditis (reported cases). Among recipients of either vaccine, there were only 13 reports or less of myocarditis beyond 10 days for any individual time from vaccination to symptom onset. The y-axis range differs between panels A and B. A, For the BNT162b2 vaccine, there were 138 reported cases of myocarditis with known date for symptom onset and dose after 114 246 837 first vaccination doses and 888 reported cases after 95 532 396 second vaccination doses. B, For the mRNA-1273 vaccine, there were 116 reported cases of myocarditis with known date for symptom onset and dose after 78 158 611 first vaccination doses and 311 reported cases after 66 163 001 second vaccination doses. Table 1. Characteristics of Reports to VAERS After mRNA-Based COVID-19 Vaccination That Met the CDC’s Case Definition for Myocarditis Between December 14, 2020, and August 31, 2021 View LargeDownload Table 2. Reports to VAERS After mRNA-Based COVID-19 Vaccination That Met the CDC’s Case Definition for Myocarditis Within a 7-Day Risk Interval per Million Doses of Vaccine Administered View LargeDownload Table 3. Symptoms, Treatment, and Outcomes in 826 Patients Younger Than 30 Years of Age With Myocarditis View LargeDownload Supplement. eMethods. Medical Dictionary for Regulatory Activities Preferred Terms, Definitions of Myocarditis and Pericarditis, Myocarditis medical review form eFigure. Flow diagram of cases of myocarditis and pericarditis reported to Vaccine Adverse Event Reporting System (VAERS) after receiving mRNA-based COVID-19 vaccine, United States, December 14, 2020-August 31, 2021. eTable 1. Characteristics of all myocarditis cases reported to Vaccine Adverse Event Reporting System (VAERS) after mRNA-based COVID-19 vaccination, United States, December 14, 2020–August 31, 2021. eTable 2. Characteristics of all pericarditis cases reported to Vaccine Adverse Event Reporting System (VAERS) after mRNA-based COVID-19 vaccination, United States, December 14, 2020–August 31, 2021. eTable 3. Characteristics of myocarditis cases reported to Vaccine Adverse Event Reporting System after mRNA-based COVID-19 vaccination by case definition status. 1. Cooper LT Jr. Myocarditis. N Engl J Med. 2009;360(15):1526-1538. doi:10.1056/NEJMra0800028PubMedGoogle ScholarCrossref 2. Vasudeva R, Bhatt P, Lilje C, et al. Trends in acute myocarditis–related pediatric hospitalizations in the United States, 2007-2016. Am J Cardiol. 2021;149:95-102. doi:10.1016/j.amjcard.2021.03.019PubMedGoogle ScholarCrossref 3. Arola A, Pikkarainen E, Sipilä JO, Pykäri J, Rautava P, Kytö V. Occurrence and features of childhood myocarditis: a nationwide study in Finland. J Am Heart Assoc. 2017;6(11):e005306. doi:10.1161/JAHA.116.005306PubMedGoogle Scholar 4. Kytö V, Sipilä J, Rautava P. The effects of gender and age on occurrence of clinically suspected myocarditis in adulthood. Heart. 2013;99(22):1681-1684. doi:10.1136/heartjnl-2013-304449PubMedGoogle ScholarCrossref 5. Dasgupta S, Iannucci G, Mao C, Clabby M, Oster ME. Myocarditis in the pediatric population: a review. Congenit Heart Dis. 2019;14(5):868-877. doi:10.1111/chd.12835PubMedGoogle ScholarCrossref 6. Pollack A, Kontorovich AR, Fuster V, Dec GW. Viral myocarditis—diagnosis, treatment options, and current controversies. Nat Rev Cardiol. 2015;12(11):670-680. doi:10.1038/nrcardio.2015.108PubMedGoogle ScholarCrossref 7. Halsell JS, Riddle JR, Atwood JE, et al; Department of Defense Smallpox Vaccination Clinical Evaluation Team. Myopericarditis following smallpox vaccination among vaccinia-naive US military personnel. JAMA. 2003;289(24):3283-3289. doi:10.1001/jama.289.24.3283 ArticlePubMedGoogle ScholarCrossref 8. Gubernot D, Jazwa A, Niu M, et al. US population-based background incidence rates of medical conditions for use in safety assessment of COVID-19 vaccines. Vaccine. 2021;39(28):3666-3677. doi:10.1016/j.vaccine.2021.05.016PubMedGoogle ScholarCrossref 9. US Centers for Disease Control and Prevention. Clinical Immunization Safety Assessment project. Accessed August 24, 2021. https://www.cdc.gov/vaccinesafety/ensuringsafety/monitoring/cisa/index.html 10. Marshall M, Ferguson ID, Lewis P, et al. Symptomatic acute myocarditis in 7 adolescents after Pfizer-BioNTech COVID-19 vaccination. Pediatrics. 2021;148(3):e2021052478. doi:10.1542/peds.2021-052478PubMedGoogle Scholar 11. Kim HW, Jenista ER, Wendell DC, et al. Patients with acute myocarditis following mRNA COVID-19 vaccination. JAMA Cardiol. 2021;6(10):1196-1201. doi:10.1001/jamacardio.2021.2828 ArticlePubMedGoogle ScholarCrossref 12. Montgomery J, Ryan M, Engler R, et al. Myocarditis following immunization with mRNA COVID-19 vaccines in members of the US military. JAMA Cardiol. 2021;6(10):1202-1206. doi:10.1001/jamacardio.2021.2833 ArticlePubMedGoogle ScholarCrossref 13. Diaz GA, Parsons GT, Gering SK, Meier AR, Hutchinson IV, Robicsek A. Myocarditis and pericarditis after vaccination for COVID-19. JAMA. 2021;326(12):1210-1212. doi:10.1001/jama.2021.13443 ArticlePubMedGoogle ScholarCrossref 14. Mevorach D, Anis E, Cedar N, et al. Myocarditis after BNT162b2 mRNA vaccine against Covid-19 in Israel. N Engl J Med. 2021;385(23):2140-2149. doi:10.1056/NEJMoa2109730PubMedGoogle ScholarCrossref 15. Witberg G, Barda N, Hoss S, et al. Myocarditis after Covid-19 vaccination in a large health care organization. N Engl J Med. 2021;385(23):2132-2139. doi:10.1056/NEJMoa2110737PubMedGoogle ScholarCrossref 16. MedDRA. Medical Dictionary for Regulatory Activities. Accessed June 30, 2021. https://www.meddra.org 17. US Centers for Disease Control and Prevention. CDC COVID-19 data tracker. Accessed June 30, 2021. https://covid.cdc.gov/covid-data-tracker 18. Gargano JW, Wallace M, Hadler SC, et al. Use of mRNA COVID-19 vaccine after reports of myocarditis among vaccine recipients: update from the Advisory Committee on Immunization Practices—United States, June 2021. MMWR Morb Mortal Wkly Rep. 2021;70(27):977-982. doi:10.15585/mmwr.mm7027e2PubMedGoogle ScholarCrossref 19. Abu Mouch S, Roguin A, Hellou E, et al. Myocarditis following COVID-19 mRNA vaccination. Vaccine. 2021;39(29):3790-3793. doi:10.1016/j.vaccine.2021.05.087PubMedGoogle ScholarCrossref 20. Larson KF, Ammirati E, Adler ED, et al. Myocarditis after BNT162b2 and mRNA-1273 vaccination. Circulation. 2021;144(6):506-508. doi:10.1161/CIRCULATIONAHA.121.055913PubMedGoogle ScholarCrossref 21. Rosner CM, Genovese L, Tehrani BN, et al. Myocarditis temporally associated with COVID-19 vaccination. Circulation. 2021;144(6):502-505. doi:10.1161/CIRCULATIONAHA.121.055891PubMedGoogle ScholarCrossref 22. Boehmer TK, Kompaniyets L, Lavery AM, et al. Association between COVID-19 and myocarditis using hospital-based administrative data—United States, March 2020-January 2021. MMWR Morb Mortal Wkly Rep. 2021;70(35):1228-1232. doi:10.15585/mmwr.mm7035e5PubMedGoogle ScholarCrossref 23. Harris PA, Taylor R, Minor BL, et al; REDCap Consortium. The REDCap Consortium: building an international community of software platform partners. J Biomed Inform. 2019;95:103208. doi:10.1016/j.jbi.2019.103208PubMedGoogle Scholar 24. Mahrholdt H, Wagner A, Deluigi CC, et al. Presentation, patterns of myocardial damage, and clinical course of viral myocarditis. Circulation. 2006;114(15):1581-1590. doi:10.1161/CIRCULATIONAHA.105.606509PubMedGoogle ScholarCrossref 25. Mason JW, O’Connell JB, Herskowitz A, et al; Myocarditis Treatment Trial Investigators. A clinical trial of immunosuppressive therapy for myocarditis. N Engl J Med. 1995;333(5):269-275. doi:10.1056/NEJM199508033330501PubMedGoogle ScholarCrossref 26. Saji T, Matsuura H, Hasegawa K, et al. Comparison of the clinical presentation, treatment, and outcome of fulminant and acute myocarditis in children. Circ J. 2012;76(5):1222-1228. doi:10.1253/circj.CJ-11-1032PubMedGoogle ScholarCrossref 27. Ghelani SJ, Spaeder MC, Pastor W, Spurney CF, Klugman D. Demographics, trends, and outcomes in pediatric acute myocarditis in the United States, 2006 to 2011. Circ Cardiovasc Qual Outcomes. 2012;5(5):622-627. doi:10.1161/CIRCOUTCOMES.112.965749PubMedGoogle ScholarCrossref 28. Caforio ALP, Pankuweit S, Arbustini E, et al; European Society of Cardiology Working Group on Myocardial and Pericardial Diseases. Current state of knowledge on aetiology, diagnosis, management, and therapy of myocarditis: a position statement of the European Society of Cardiology Working Group on Myocardial and Pericardial Diseases. Eur Heart J. 2013;34(33):2636-2648. doi:10.1093/eurheartj/eht210PubMedGoogle ScholarCrossref 29. Yancy CW, Jessup M, Bozkurt B, et al; American College of Cardiology Foundation; American Heart Association Task Force on Practice Guidelines. 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2013;62(16):e147-e239. doi:10.1016/j.jacc.2013.05.019PubMedGoogle ScholarCrossref 30. Law YM, Lal AK, Chen S, et al; American Heart Association Pediatric Heart Failure and Transplantation Committee of the Council on Lifelong Congenital Heart Disease and Heart Health in the Young and Stroke Council. Diagnosis and management of myocarditis in children: a scientific statement from the American Heart Association. Circulation. 2021;144(6):e123-e135. doi:10.1161/CIR.0000000000001001PubMedGoogle ScholarCrossref 31. US Centers for Disease Control and Prevention. Clinical considerations: myocarditis and pericarditis after receipt of mRNA COVID-19 vaccines among adolescents and young adults. Accessed August 24, 2021. https://www.cdc.gov/vaccines/covid-19/clinical-considerations/myocarditis.html 32. Sachdeva S, Song X, Dham N, Heath DM, DeBiasi RL. Analysis of clinical parameters and cardiac magnetic resonance imaging as predictors of outcome in pediatric myocarditis. Am J Cardiol. 2015;115(4):499-504. doi:10.1016/j.amjcard.2014.11.029PubMedGoogle ScholarCrossref 33. Ferreira VM, Schulz-Menger J, Holmvang G, et al. Cardiovascular magnetic resonance in nonischemic myocardial inflammation: expert recommendations. J Am Coll Cardiol. 2018;72(24):3158-3176. doi:10.1016/j.jacc.2018.09.072PubMedGoogle ScholarCrossref 34. US Centers for Disease Control and Prevention. Investigating long-term effects of myocarditis. Accessed August 24, 2021. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/myo-outcomes.html 35. Maron BJ, Udelson JE, Bonow RO, et al; American Heart Association Electrocardiography and Arrhythmias Committee of Council on Clinical Cardiology, Council on Cardiovascular Disease in Young, Council on Cardiovascular and Stroke Nursing, Council on Functional Genomics and Translational Biology, and American College of Cardiology. Eligibility and disqualification recommendations for competitive athletes with cardiovascular abnormalities: task force 3: hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy and other cardiomyopathies, and myocarditis: a scientific statement from the American Heart Association and American College of Cardiology. Circulation. 2015;132(22):e273-e280. doi:10.1161/CIR.0000000000000239PubMedGoogle Scholar 36. Aquaro GD, Ghebru Habtemicael Y, Camastra G, et al; Cardiac Magnetic Resonance Working Group of the Italian Society of Cardiology. Prognostic value of repeating cardiac magnetic resonance in patients with acute myocarditis. J Am Coll Cardiol. 2019;74(20):2439-2448. doi:10.1016/j.jacc.2019.08.1061PubMedGoogle ScholarCrossref 37. US Centers for Disease Control and Prevention. Interim clinical considerations for use of COVID-19 vaccines currently authorized in the United States. Accessed August 24, 2021. https://www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html 38. Shimabukuro TT, Nguyen M, Martin D, DeStefano F. Safety monitoring in the Vaccine Adverse Event Reporting System (VAERS). Vaccine. 2015;33(36):4398-4405. doi:10.1016/j.vaccine.2015.07.035PubMedGoogle ScholarCrossref 39. US Centers for Disease Control and Prevention. HIPAA privacy rule and public health: guidance from CDC and the US Department of Health and Human Services. MMWR Suppl. 2003;52:1-17, 19-20.PubMedGoogle Scholar * Myocarditis and Pericarditis After Vaccination for COVID-19 Research Letter September 28, 2021 This study investigates the incidence of myocarditis and pericarditis emergency department or inpatient hospital encounters before COVID-19 vaccine availability (January 2019–January 2021) and during a COVID-19 vaccination period (February-May 2021) in a large US health care system. George A. Diaz, MD; Guilford T. Parsons, MD, MS; Sara K. Gering, BS, BSN; Audrey R. Meier, MPH; Ian V. Hutchinson, PhD, DSc; Ari Robicsek, MD * Myocarditis Following Immunization With mRNA COVID-19 Vaccines in Members of the US Military Brief Report October 1, 2021 This case series describes myocarditis presenting after COVID-19 vaccination within the Military Health System. Jay Montgomery, MD; Margaret Ryan, MD, MPH; Renata Engler, MD; Donna Hoffman, MSN; Bruce McClenathan, MD; Limone Collins, MD; David Loran, DNP; David Hrncir, MD; Kelsie Herring, MD; Michael Platzer, MD; Nehkonti Adams, MD; Aliye Sanou, MD; Leslie T. Cooper Jr, MD * Patients With Acute Myocarditis Following mRNA COVID-19 Vaccination Brief Report October 1, 2021 This study describes 4 patients who presented with acute myocarditis after mRNA COVID-19 vaccination. Han W. Kim, MD; Elizabeth R. Jenista, PhD; David C. Wendell, PhD; Clerio F. Azevedo, MD; Michael J. Campbell, MD; Stephen N. Darty, BS; Michele A. Parker, MS; Raymond J. Kim, MD * Association of Myocarditis With BNT162b2 Vaccination in Children Brief Report December 1, 2021 This case series reviews comprehensive cardiac imaging in children with myocarditis after COVID-19 vaccine. Audrey Dionne, MD; Francesca Sperotto, MD; Stephanie Chamberlain; Annette L. Baker, MSN, CPNP; Andrew J. Powell, MD; Ashwin Prakash, MD; Daniel A. Castellanos, MD; Susan F. Saleeb, MD; Sarah D. de Ferranti, MD, MPH; Jane W. Newburger, MD, MPH; Kevin G. Friedman, MD SEE MORE ABOUT Public Health Vaccination Cardiology Coronavirus (COVID-19) TRENDING * Association of Myocarditis With BNT162b2 Vaccination in Children JAMA Cardiology Research December 1, 2021 * Association Between 3 Doses of mRNA COVID-19 Vaccine and Symptomatic Infection Caused by Omicron and Delta Variants JAMA Research January 21, 2022 * Surveillance for Adverse Events After COVID-19 mRNA Vaccination JAMA Research October 12, 2021 -------------------------------------------------------------------------------- SELECT YOUR INTERESTS SELECT YOUR INTERESTS Customize your JAMA Network experience by selecting one or more topics from the list below. * Acid Base, Electrolytes, Fluids * Addiction Medicine * Allergy and Clinical Immunology * Anesthesiology * Anticoagulation * Art and Images in Psychiatry * Bleeding and Transfusion * Cardiology * Caring for the Critically Ill Patient * Challenges in Clinical Electrocardiography * Clinical Challenge * Clinical Decision Support * Clinical Implications of Basic Neuroscience * Clinical Pharmacy and Pharmacology * Complementary and Alternative Medicine * Consensus Statements * Coronavirus (COVID-19) * Critical Care Medicine * Cultural Competency * Dental Medicine * Dermatology * Diabetes and Endocrinology * Diagnostic Test Interpretation * Diversity, Equity, and Inclusion * Drug Development * Electronic Health Records * Emergency Medicine * End of Life * Environmental Health * Ethics * Facial Plastic Surgery * Gastroenterology and Hepatology * Genetics and Genomics * Genomics and Precision Health * Geriatrics * Global Health * Guide to Statistics and Medicine * Guidelines * Hair Disorders * Health Care Delivery Models * Health Care Economics, Insurance, Payment * Health Care Quality * Health Care Reform * Health Care Safety * Health Care Workforce * Health Disparities * Health Inequities * Health Informatics * Health Policy * Hematology * History of Medicine * Humanities * Hypertension * Images in Neurology * Implementation Science * Infectious Diseases * Innovations in Health Care Delivery * JAMA Infographic * Law and Medicine * Leading Change * Less is More * LGBTQ * Lifestyle Behaviors * Medical Coding * Medical Devices and Equipment * Medical Education * Medical Education and Training * Medical Journals and Publishing * Melanoma * Mobile Health and Telemedicine * Narrative Medicine * Nephrology * Neurology * Neuroscience and Psychiatry * Notable Notes * Nursing * Nutrition * Nutrition, Obesity, Exercise * Obesity * Obstetrics and Gynecology * Occupational Health * Oncology * Ophthalmic Images * Ophthalmology * Orthopedics * Otolaryngology * Pain Medicine * Pathology and Laboratory Medicine * Patient Care * Patient Information * Pediatrics * Performance Improvement * Performance Measures * Perioperative Care and Consultation * Pharmacoeconomics * Pharmacoepidemiology * Pharmacogenetics * Pharmacy and Clinical Pharmacology * Physical Medicine and Rehabilitation * Physical Therapy * Physician Leadership * Poetry * Population Health * Preventive Medicine * Professional Well-being * Professionalism * Psychiatry and Behavioral Health * Public Health * Pulmonary Medicine * Radiology * Regulatory Agencies * Research, Methods, Statistics * Resuscitation * Rheumatology * Risk Management * Scientific Discovery and the Future of Medicine * Shared Decision Making and Communication * Sleep Medicine * Sports Medicine * Stem Cell Transplantation * Surgery * Surgical Innovation * Surgical Pearls * Teachable Moment * Technology and Finance * The Art of JAMA * The Arts and Medicine * The Rational Clinical Examination * Tobacco and e-Cigarettes * Toxicology * Trauma and Injury * Treatment Adherence * Ultrasonography * Urology * Users' Guide to the Medical Literature * Vaccination * Venous Thromboembolism * Veterans Health * Violence * Women's Health * Workflow and Process * Wound Care, Infection, Healing Save Preferences Privacy Policy | Terms of Use OTHERS ALSO LIKED WE RECOMMEND 1. Myocarditis after vaccination against covid-19 Walid F Gellad et al., The BMJ, 2021 2. CDC releases guidance for clinicians on heart inflammation after COVID-19 vaccination Melissa Jenco et al., AAP News, 2021 1. Covid-19: Study that claimed boys are at increased risk of myocarditis after vaccination is deeply flawed, say critics Clara Munro, The BMJ, 2021 2. Health officials, AAP urge COVID-19 vaccination despite rare myocarditis cases Melissa Jenco et al., AAP News, 2021 Powered by * Privacy policy * Do not sell my personal information * Google Analytics settings I consent to the use of Google Analytics and related cookies across the TrendMD network (widget, website, blog). Learn more Yes No This Issue Views 111,491 Citations 0 3000 View Metrics * Download PDF * Twitter Facebook More LinkedIn * CME & MOC * Cite This CITATION Oster ME, Shay DK, Su JR, et al. Myocarditis Cases Reported After mRNA-Based COVID-19 Vaccination in the US From December 2020 to August 2021. JAMA. 2022;327(4):331–340. doi:10.1001/jama.2021.24110 DOWNLOAD CITATION FILE: Ris (Zotero) EndNote BibTex Medlars ProCite RefWorks Reference Manager Mendeley © 2022 * Permissions Original Investigation January 25, 2022 MYOCARDITIS CASES REPORTED AFTER MRNA-BASED COVID-19 VACCINATION IN THE US FROM DECEMBER 2020 TO AUGUST 2021 Matthew E. Oster, MD, MPH1,2,3; David K. Shay, MD, MPH1; John R. Su, MD, PhD, MPH1; et al Julianne Gee, MPH1; C. Buddy Creech, MD, MPH4; Karen R. Broder, MD1; Kathryn Edwards, MD4; Jonathan H. Soslow, MD, MSCI4; Jeffrey M. Dendy, MD4; Elizabeth Schlaudecker, MD, MPH5; Sean M. Lang, MD5; Elizabeth D. Barnett, MD6; Frederick L. Ruberg, MD6; Michael J. Smith, MD, MSCE7; M. Jay Campbell, MD, MHA7; Renato D. Lopes, MD, PhD, MHS7; Laurence S. Sperling, MD1,2; Jane A. Baumblatt, MD8; Deborah L. Thompson, MD, MSPH8; Paige L. Marquez, MSPH1; Penelope Strid, MPH1; Jared Woo, MPH1; River Pugsley, PhD, MPH1; Sarah Reagan-Steiner, MD, MPH1; Frank DeStefano, MD, MPH1; Tom T. Shimabukuro, MD, MPH, MBA1 Author Affiliations Article Information * 1US Centers for Disease Control and Prevention, Atlanta, Georgia * 2School of Medicine, Emory University, Atlanta, Georgia * 3Children’s Healthcare of Atlanta, Atlanta, Georgia * 4Vanderbilt University Medical Center, Nashville, Tennessee * 5Cincinnati Children’s Hospital Medical Center, Cincinnati, Ohio * 6Boston Medical Center, Boston, Massachusetts * 7Duke University, Durham, North Carolina * 8US Food and Drug Administration, Silver Spring, Maryland JAMA. 2022;327(4):331-340. doi:10.1001/jama.2021.24110 visual abstract icon Visual Abstract editorial comment icon Editorial Comment related articles icon Related Articles author interview icon Interviews multimedia icon Multimedia * Research Letter Myocarditis and Pericarditis After Vaccination for COVID-19 George A. Diaz, MD; Guilford T. Parsons, MD, MS; Sara K. Gering, BS, BSN; Audrey R. Meier, MPH; Ian V. Hutchinson, PhD, DSc; Ari Robicsek, MD * Brief Report Myocarditis Following Immunization With mRNA COVID-19 Vaccines in Members of the US Military Jay Montgomery, MD; Margaret Ryan, MD, MPH; Renata Engler, MD; Donna Hoffman, MSN; Bruce McClenathan, MD; Limone Collins, MD; David Loran, DNP; David Hrncir, MD; Kelsie Herring, MD; Michael Platzer, MD; Nehkonti Adams, MD; Aliye Sanou, MD; Leslie T. Cooper Jr, MD * Brief Report Patients With Acute Myocarditis Following mRNA COVID-19 Vaccination Han W. Kim, MD; Elizabeth R. Jenista, PhD; David C. Wendell, PhD; Clerio F. Azevedo, MD; Michael J. Campbell, MD; Stephen N. Darty, BS; Michele A. Parker, MS; Raymond J. Kim, MD * Brief Report Association of Myocarditis With BNT162b2 Vaccination in Children Audrey Dionne, MD; Francesca Sperotto, MD; Stephanie Chamberlain; Annette L. Baker, MSN, CPNP; Andrew J. Powell, MD; Ashwin Prakash, MD; Daniel A. Castellanos, MD; Susan F. Saleeb, MD; Sarah D. de Ferranti, MD, MPH; Jane W. Newburger, MD, MPH; Kevin G. Friedman, MD Key Points Question What is the risk of myocarditis after mRNA-based COVID-19 vaccination in the US? Findings In this descriptive study of 1626 cases of myocarditis in a national passive reporting system, the crude reporting rates within 7 days after vaccination exceeded the expected rates across multiple age and sex strata. The rates of myocarditis cases were highest after the second vaccination dose in adolescent males aged 12 to 15 years (70.7 per million doses of the BNT162b2 vaccine), in adolescent males aged 16 to 17 years (105.9 per million doses of the BNT162b2 vaccine), and in young men aged 18 to 24 years (52.4 and 56.3 per million doses of the BNT162b2 vaccine and the mRNA-1273 vaccine, respectively). Meaning Based on passive surveillance reporting in the US, the risk of myocarditis after receiving mRNA-based COVID-19 vaccines was increased across multiple age and sex strata and was highest after the second vaccination dose in adolescent males and young men. Abstract Importance Vaccination against COVID-19 provides clear public health benefits, but vaccination also carries potential risks. The risks and outcomes of myocarditis after COVID-19 vaccination are unclear. Objective To describe reports of myocarditis and the reporting rates after mRNA-based COVID-19 vaccination in the US. Design, Setting, and Participants Descriptive study of reports of myocarditis to the Vaccine Adverse Event Reporting System (VAERS) that occurred after mRNA-based COVID-19 vaccine administration between December 2020 and August 2021 in 192 405 448 individuals older than 12 years of age in the US; data were processed by VAERS as of September 30, 2021. Exposures Vaccination with BNT162b2 (Pfizer-BioNTech) or mRNA-1273 (Moderna). Main Outcomes and Measures Reports of myocarditis to VAERS were adjudicated and summarized for all age groups. Crude reporting rates were calculated across age and sex strata. Expected rates of myocarditis by age and sex were calculated using 2017-2019 claims data. For persons younger than 30 years of age, medical record reviews and clinician interviews were conducted to describe clinical presentation, diagnostic test results, treatment, and early outcomes. Results Among 192 405 448 persons receiving a total of 354 100 845 mRNA-based COVID-19 vaccines during the study period, there were 1991 reports of myocarditis to VAERS and 1626 of these reports met the case definition of myocarditis. Of those with myocarditis, the median age was 21 years (IQR, 16-31 years) and the median time to symptom onset was 2 days (IQR, 1-3 days). Males comprised 82% of the myocarditis cases for whom sex was reported. The crude reporting rates for cases of myocarditis within 7 days after COVID-19 vaccination exceeded the expected rates of myocarditis across multiple age and sex strata. The rates of myocarditis were highest after the second vaccination dose in adolescent males aged 12 to 15 years (70.7 per million doses of the BNT162b2 vaccine), in adolescent males aged 16 to 17 years (105.9 per million doses of the BNT162b2 vaccine), and in young men aged 18 to 24 years (52.4 and 56.3 per million doses of the BNT162b2 vaccine and the mRNA-1273 vaccine, respectively). There were 826 cases of myocarditis among those younger than 30 years of age who had detailed clinical information available; of these cases, 792 of 809 (98%) had elevated troponin levels, 569 of 794 (72%) had abnormal electrocardiogram results, and 223 of 312 (72%) had abnormal cardiac magnetic resonance imaging results. Approximately 96% of persons (784/813) were hospitalized and 87% (577/661) of these had resolution of presenting symptoms by hospital discharge. The most common treatment was nonsteroidal anti-inflammatory drugs (589/676; 87%). Conclusions and Relevance Based on passive surveillance reporting in the US, the risk of myocarditis after receiving mRNA-based COVID-19 vaccines was increased across multiple age and sex strata and was highest after the second vaccination dose in adolescent males and young men. This risk should be considered in the context of the benefits of COVID-19 vaccination. Introduction Myocarditis is an inflammatory condition of the heart muscle that has a bimodal peak incidence during infancy and adolescence or young adulthood.1-4 The clinical presentation and course of myocarditis is variable, with some patients not requiring treatment and others experiencing severe heart failure that requires subsequent heart transplantation or leads to death.5 Onset of myocarditis typically follows an inciting process, often a viral illness; however, no antecedent cause is identified in many cases.6 It has been hypothesized that vaccination can serve as a trigger for myocarditis; however, only the smallpox vaccine has previously been causally associated with myocarditis based on reports among US military personnel, with cases typically occurring 7 to 12 days after vaccination.7 With the implementation of a large-scale, national COVID-19 vaccination program starting in December 2020, the US Centers for Disease Control and Prevention (CDC) and the US Food and Drug Administration began monitoring for a number of adverse events of special interest, including myocarditis and pericarditis, in the Vaccine Adverse Event Reporting System (VAERS), a long-standing national spontaneous reporting (passive surveillance) system.8 As the reports of myocarditis after COVID-19 vaccination were reported to VAERS, the Clinical Immunization Safety Assessment Project,9 a collaboration between the CDC and medical research centers, which includes physicians treating infectious diseases and other specialists (eg, cardiologists), consulted on several of the cases. In addition, reports from several countries raised concerns that mRNA-based COVID-19 vaccines may be associated with acute myocarditis.10-15 Given this concern, the aims were to describe reports and confirmed cases of myocarditis initially reported to VAERS after mRNA-based COVID-19 vaccination and to provide estimates of the risk of myocarditis after mRNA-based COVID-19 vaccination based on age, sex, and vaccine type. Methods Data Sources VAERS is a US spontaneous reporting (passive surveillance) system that functions as an early warning system for potential vaccine adverse events.8 Co-administered by the CDC and the US Food and Drug Administration, VAERS accepts reports of all adverse events after vaccination from patients, parents, clinicians, vaccine manufacturers, and others regardless of whether the events could plausibly be associated with receipt of the vaccine. Reports to VAERS include information about the vaccinated person, the vaccine or vaccines administered, and the adverse events experienced by the vaccinated person. The reports to VAERS are then reviewed by third-party professional coders who have been trained in the assignment of Medical Dictionary for Regulatory Activities preferred terms.16 The coders then assign appropriate terms based on the information available in the reports. This activity was reviewed by the CDC and was conducted to be consistent with applicable federal law and CDC policy. The activities herein were confirmed to be nonresearch under the Common Rule in accordance with institutional procedures and therefore were not subject to institutional review board requirements. Informed consent was not obtained for this secondary use of existing information; see 45 CFR part 46.102(l)(2), 21 CFR part 56, 42 USC §241(d), 5 USC §552a, and 44 USC §3501 et seq. Exposure The exposure of concern was vaccination with one of the mRNA-based COVID-19 vaccines: the BNT162b2 vaccine (Pfizer-BioNTech) or the mRNA-1273 vaccine (Moderna). During the analytic period, persons aged 12 years or older were eligible for the BNT162b2 vaccine and persons aged 18 years or older were eligible for the mRNA-1273 vaccine. The number of COVID-19 vaccine doses administered during the analytic period was obtained through the CDC’s COVID-19 Data Tracker.17 Outcomes The primary outcome was the occurrence of myocarditis and the secondary outcome was pericarditis. Reports to VAERS with these outcomes were initially characterized using the Medical Dictionary for Regulatory Activities preferred terms of myocarditis or pericarditis (specific terms are listed in the eMethods in the Supplement). After initial review of reports of myocarditis to VAERS and review of the patient’s medical records (when available), the reports were further reviewed by CDC physicians and public health professionals to verify that they met the CDC’s case definition for probable or confirmed myocarditis (descriptions previously published and included in the eMethods in the Supplement).18 The CDC’s case definition of probable myocarditis requires the presence of new concerning symptoms, abnormal cardiac test results, and no other identifiable cause of the symptoms and findings. Confirmed cases of myocarditis further require histopathological confirmation of myocarditis or cardiac magnetic resonance imaging (MRI) findings consistent with myocarditis. Deaths were included only if the individual had met the case definition for confirmed myocarditis and there was no other identifiable cause of death. Individual cases not involving death were included only if the person had met the case definition for probable myocarditis or confirmed myocarditis. Statistical Analysis We characterized reports of myocarditis or pericarditis after COVID-19 vaccination that met the CDC’s case definition and were received by VAERS between December 14, 2020 (when COVID-19 vaccines were first publicly available in the US), and August 31, 2021, by age, sex, race, ethnicity, and vaccine type; data were processed by VAERS as of September 30, 2021. Race and ethnicity were optional fixed categories available by self-identification at the time of vaccination or by the individual filing a VAERS report. Race and ethnicity were included to provide the most complete baseline description possible for individual reports; however, further analyses were not stratified by race and ethnicity due to the high percentage of missing data. Reports of pericarditis with evidence of potential myocardial involvement were included in the review of reports of myocarditis. The eFigure in the Supplement outlines the categorization of the reports of myocarditis and pericarditis reviewed. Further analyses were conducted only for myocarditis because of the preponderance of those reports to VAERS, in Clinical Immunization Safety Assessment Project consultations, and in published articles.10-12,19-21 Crude reporting rates for myocarditis during a 7-day risk interval were calculated using the number of reports of myocarditis to VAERS per million doses of COVID-19 vaccine administered during the analytic period and stratified by age, sex, vaccination dose (first, second, or unknown), and vaccine type. Expected rates of myocarditis by age and sex were calculated using 2017-2019 data from the IBM MarketScan Commercial Research Database. This database contains individual-level, deidentified, inpatient and outpatient medical and prescription drug claims, and enrollment information submitted to IBM Watson Health by large employers and health plans. The data were accessed using version 4.0 of the IBM MarketScan Treatment Pathways analytic platform. Age- and sex-specific rates were calculated by determining the number of individuals with myocarditis (International Statistical Classification of Diseases and Related Health Problems, Tenth Revision [ICD-10] codes B33.20, B33.22, B33.24, I40.0, I40.1, I40.8, I40.9, or I51.4)22 identified during an inpatient encounter in 2017-2019 relative to the number of individuals of similar age and sex who were continually enrolled during the year in which the myocarditis-related hospitalization occurred; individuals with any diagnosis of myocarditis prior to that year were excluded. Given the limitations of the IBM MarketScan Commercial Research Database to capture enrollees aged 65 years or older, an expected rate for myocarditis was not calculated for this population. A 95% CI was calculated using Poisson distribution in SAS version 9.4 (SAS Institute Inc) for each expected rate of myocarditis and for each observed rate in a strata with at least 1 case. In cases of probable or confirmed myocarditis among those younger than 30 years of age, their clinical course was then summarized to the extent possible based on medical review and clinician interviews. This clinical course included presenting symptoms, diagnostic test results, treatment, and early outcomes (abstraction form appears in the eMethods in the Supplement).23 When applicable, missing data were delineated in the results or the numbers with complete data were listed. No assumptions or imputations were made regarding missing data. Any percentages that were calculated included only those cases of myocarditis with adequate data to calculate the percentages. Results Case Characteristics Between December 14, 2020, and August 31, 2021, 192 405 448 individuals older than 12 years of age received a total of 354 100 845 mRNA-based COVID-19 vaccines. VAERS received 1991 reports of myocarditis (391 of which also included pericarditis) after receipt of at least 1 dose of mRNA-based COVID-19 vaccine (eTable 1 in the Supplement) and 684 reports of pericarditis without the presence of myocarditis (eTable 2 in the Supplement). Of the 1991 reports of myocarditis, 1626 met the CDC’s case definition for probable or confirmed myocarditis (Table 1). There were 208 reports that did not meet the CDC’s case definition for myocarditis and 157 reports that required more information to perform adjudication (eTable 3 in the Supplement). Of the 1626 reports that met the CDC’s case definition for myocarditis, 1195 (73%) were younger than 30 years of age, 543 (33%) were younger than 18 years of age, and the median age was 21 years (IQR, 16-31 years) (Figure 1). Of the reports of myocarditis with dose information, 82% (1265/1538) occurred after the second vaccination dose. Of those with a reported dose and time to symptom onset, the median time from vaccination to symptom onset was 3 days (IQR, 1-8 days) after the first vaccination dose and 74% (187/254) of myocarditis events occurred within 7 days. After the second vaccination dose, the median time to symptom onset was 2 days (IQR, 1-3 days) and 90% (1081/1199) of myocarditis events occurred within 7 days (Figure 2). Males comprised 82% (1334/1625) of the cases of myocarditis for whom sex was reported. The largest proportions of cases of myocarditis were among White persons (non-Hispanic or ethnicity not reported; 69% [914/1330]) and Hispanic persons (of all races; 17% [228/1330]). Among persons younger than 30 years of age, there were no confirmed cases of myocarditis in those who died after mRNA-based COVID-19 vaccination without another identifiable cause and there was 1 probable case of myocarditis but there was insufficient information available for a thorough investigation. At the time of data review, there were 2 reports of death in persons younger than 30 years of age with potential myocarditis that remain under investigation and are not included in the case counts. Reporting Rates of Myocarditis Within 7 Days After COVID-19 Vaccination Symptom onset of myocarditis was within 7 days after vaccination for 947 reports of individuals who received the BNT162b2 vaccine and for 382 reports of individuals who received the mRNA-1273 vaccine. The rates of myocarditis varied by vaccine type, sex, age, and first or second vaccination dose (Table 2). The reporting rates of myocarditis were highest after the second vaccination dose in adolescent males aged 12 to 15 years (70.73 [95% CI, 61.68-81.11] per million doses of the BNT162b2 vaccine), in adolescent males aged 16 to 17 years (105.86 [95% CI, 91.65-122.27] per million doses of the BNT162b2 vaccine), and in young men aged 18 to 24 years (52.43 [95% CI, 45.56-60.33] per million doses of the BNT162b2 vaccine and 56.31 [95% CI, 47.08-67.34] per million doses of the mRNA-1273 vaccine). The lower estimate of the 95% CI for reporting rates of myocarditis in adolescent males and young men exceeded the upper bound of the expected rates after the first vaccination dose with the BNT162b2 vaccine in those aged 12 to 24 years, after the second vaccination dose with the BNT162b2 vaccine in those aged 12 to 49 years, after the first vaccination dose with the mRNA-1273 vaccine in those aged 18 to 39 years, and after the second vaccination dose with the mRNA-1273 vaccine in those aged 18 to 49 years. The reporting rates of myocarditis in females were lower than those in males across all age strata younger than 50 years of age. The reporting rates of myocarditis were highest after the second vaccination dose in adolescent females aged 12 to 15 years (6.35 [95% CI, 4.05-9.96] per million doses of the BNT162b2 vaccine), in adolescent females aged 16 to 17 years (10.98 [95% CI, 7.16-16.84] per million doses of the BNT162b2 vaccine), in young women aged 18 to 24 years (6.87 [95% CI, 4.27-11.05] per million doses of the mRNA-1273 vaccine), and in women aged 25 to 29 years (8.22 [95% CI, 5.03-13.41] per million doses of the mRNA-1273 vaccine). The lower estimate of the 95% CI for reporting rates of myocarditis in females exceeded the upper bound of the expected rates after the second vaccination dose with the BNT162b2 vaccine in those aged 12 to 29 years and after the second vaccination dose with the mRNA-1273 vaccine in those aged 18 to 29 years. Clinical Course of Myocarditis After COVID-19 Vaccination in Persons Younger Than 30 Years of Age Among the 1372 reports of myocarditis in persons younger than 30 years of age, 1305 were able to be adjudicated, with 92% (1195/1305) meeting the CDC’s case definition. Of these, chart abstractions or medical interviews were completed for 69% (826/1195) (Table 3). The symptoms commonly reported in the verified cases of myocarditis in persons younger than 30 years of age included chest pain, pressure, or discomfort (727/817; 89%) and dyspnea or shortness of breath (242/817; 30%). Troponin levels were elevated in 98% (792/809) of the cases of myocarditis. The electrocardiogram result was abnormal in 72% (569/794) of cases of myocarditis. Of the patients who had received a cardiac MRI, 72% (223/312) had abnormal findings consistent with myocarditis. The echocardiogram results were available for 721 cases of myocarditis; of these, 84 (12%) demonstrated a notable decreased left ventricular ejection fraction (<50%). Among the 676 cases for whom treatment data were available, 589 (87%) received nonsteroidal anti-inflammatory drugs. Intravenous immunoglobulin and glucocorticoids were each used in 12% of the cases of myocarditis (78/676 and 81/676, respectively). Intensive therapies such as vasoactive medications (12 cases of myocarditis) and intubation or mechanical ventilation (2 cases) were rare. There were no verified cases of myocarditis requiring a heart transplant, extracorporeal membrane oxygenation, or a ventricular assist device. Of the 96% (784/813) of cases of myocarditis who were hospitalized, 98% (747/762) were discharged from the hospital at time of review. In 87% (577/661) of discharged cases of myocarditis, there was resolution of the presenting symptoms by hospital discharge. Discussion In this review of reports to VAERS between December 2020 and August 2021, myocarditis was identified as a rare but serious adverse event that can occur after mRNA-based COVID-19 vaccination, particularly in adolescent males and young men. However, this increased risk must be weighed against the benefits of COVID-19 vaccination.18 Compared with cases of non–vaccine-associated myocarditis, the reports of myocarditis to VAERS after mRNA-based COVID-19 vaccination were similar in demographic characteristics but different in their acute clinical course. First, the greater frequency noted among vaccine recipients aged 12 to 29 years vs those aged 30 years or older was similar to the age distribution seen in typical cases of myocarditis.2,4 This pattern may explain why cases of myocarditis were not discovered until months after initial Emergency Use Authorization of the vaccines in the US (ie, until the vaccines were widely available to younger persons). Second, the sex distribution in cases of myocarditis after COVID-19 vaccination was similar to that seen in typical cases of myocarditis; there is a strong male predominance for both conditions.2,4 However, the onset of myocarditis symptoms after exposure to a potential immunological trigger was shorter for COVID-19 vaccine–associated cases of myocarditis than is typical for myocarditis cases diagnosed after a viral illness.24-26 Cases of myocarditis reported after COVID-19 vaccination were typically diagnosed within days of vaccination, whereas cases of typical viral myocarditis can often have indolent courses with symptoms sometimes present for weeks to months after a trigger if the cause is ever identified.1 The major presenting symptoms appeared to resolve faster in cases of myocarditis after COVID-19 vaccination than in typical viral cases of myocarditis. Even though almost all individuals with cases of myocarditis were hospitalized and clinically monitored, they typically experienced symptomatic recovery after receiving only pain management. In contrast, typical viral cases of myocarditis can have a more variable clinical course. For example, up to 6% of typical viral myocarditis cases in adolescents require a heart transplant or result in mortality.27 In the current study, the initial evaluation and treatment of COVID-19 vaccine–associated myocarditis cases was similar to that of typical myocarditis cases.28-31 Initial evaluation usually included measurement of troponin level, electrocardiography, and echocardiography.1 Cardiac MRI was often used for diagnostic purposes and also for possible prognostic purposes.32,33 Supportive care was a mainstay of treatment, with specific cardiac or intensive care therapies as indicated by the patient’s clinical status. Long-term outcome data are not yet available for COVID-19 vaccine–associated myocarditis cases. The CDC has started active follow-up surveillance in adolescents and young adults to assess the health and functional status and cardiac outcomes at 3 to 6 months in probable and confirmed cases of myocarditis reported to VAERS after COVID-19 vaccination.34 For patients with myocarditis, the American Heart Association and the American College of Cardiology guidelines advise that patients should be instructed to refrain from competitive sports for 3 to 6 months, and that documentation of a normal electrocardiogram result, ambulatory rhythm monitoring, and an exercise test should be obtained prior to resumption of sports.35 The use of cardiac MRI is unclear, but it may be useful in evaluating the progression or resolution of myocarditis in those with abnormalities on the baseline cardiac MRI.36 Further doses of mRNA-based COVID-19 vaccines should be deferred, but may be considered in select circumstances.37 Limitations This study has several limitations. First, although clinicians are required to report serious adverse events after COVID-19 vaccination, including all events leading to hospitalization, VAERS is a passive reporting system. As such, the reports of myocarditis to VAERS may be incomplete, and the quality of the information reported is variable. Missing data for sex, vaccination dose number, and race and ethnicity were not uncommon in the reports received; history of prior SARS-CoV-2 infection also was not known. Furthermore, as a passive system, VAERS data are subject to reporting biases in that both underreporting and overreporting are possible.38 Given the high verification rate of reports of myocarditis to VAERS after mRNA-based COVID-19 vaccination, underreporting is more likely. Therefore, the actual rates of myocarditis per million doses of vaccine are likely higher than estimated. Second, efforts by CDC investigators to obtain medical records or interview physicians were not always successful despite the special allowance for sharing information with the CDC under the Health Insurance Portability and Accountability Act of 1996.39 This challenge limited the ability to perform case adjudication and complete investigations for some reports of myocarditis, although efforts are still ongoing when feasible. Third, the data from vaccination administration were limited to what is reported to the CDC and thus may be incomplete, particularly with regard to demographics. Fourth, calculation of expected rates from the IBM MarketScan Commercial Research Database relied on administrative data via the use of ICD-10 codes and there was no opportunity for clinical review. Furthermore, these data had limited information regarding the Medicare population; thus expected rates for those older than 65 years of age were not calculated. However, it is expected that the rates in those older than 65 years of age would not be higher than the rates in those aged 50 to 64 years.4 Conclusions Based on passive surveillance reporting in the US, the risk of myocarditis after receiving mRNA-based COVID-19 vaccines was increased across multiple age and sex strata and was highest after the second vaccination dose in adolescent males and young men. This risk should be considered in the context of the benefits of COVID-19 vaccination. Back to top Article Information Corresponding Author: Matthew E. Oster, MD, MPH, US Centers for Disease Control and Prevention, 1600 Clifton Rd, Atlanta, GA 30333 (eocevent416@cdc.gov). Accepted for Publication: December 16, 2021. Author Contributions: Drs Oster and Su had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Concept and design: Oster, Shay, Su, Creech, Edwards, Dendy, Schlaudecker, Woo, Shimabukuro. Acquisition, analysis, or interpretation of data: Oster, Shay, Su, Gee, Creech, Broder, Edwards, Soslow, Schlaudecker, Lang, Barnett, Ruberg, Smith, Campbell, Lopes, Sperling, Baumblatt, Thompson, Marquez, Strid, Woo, Pugsley, Reagan-Steiner, DeStefano, Shimabukuro. Drafting of the manuscript: Oster, Shay, Su, Gee, Creech, Marquez, Strid, Woo, Shimabukuro. Critical revision of the manuscript for important intellectual content: Oster, Shay, Su, Creech, Broder, Edwards, Soslow, Dendy, Schlaudecker, Lang, Barnett, Ruberg, Smith, Campbell, Lopes, Sperling, Baumblatt, Thompson, Pugsley, Reagan-Steiner, DeStefano, Shimabukuro. Statistical analysis: Oster, Su, Marquez, Strid, Woo, Shimabukuro. Obtained funding: Edwards, DeStefano. Administrative, technical, or material support: Oster, Gee, Creech, Broder, Edwards, Soslow, Schlaudecker, Smith, Baumblatt, Thompson, Reagan-Steiner, DeStefano. Supervision: Su, Edwards, Soslow, Dendy, Schlaudecker, Campbell, Sperling, DeStefano, Shimabukuro. Conflict of Interest Disclosures: Dr Creech reported receiving grants from the National Institutes of Health for the Moderna and Janssen clinical trials and receiving personal fees from Astellas and Horizon. Dr Edwards reported receiving grants from the National Institutes of Health; receiving personal fees from BioNet, IBM, X-4 Pharma, Seqirus, Roche, Pfizer, Merck, Moderna, and Sanofi; and receiving compensation for being the associate editor of Clinical Infectious Diseases. Dr Soslow reported receiving personal fees from Esperare. Dr Schlaudecker reported receiving grants from Pfizer and receiving personal fees from Sanofi Pasteur. Drs Barnett, Ruberg, and Smith reported receiving grants from Pfizer. Dr Lopes reported receiving personal fees from Bayer, Boehringer Ingleheim, Bristol Myers Squibb, Daiichi Sankyo, GlaxoSmithKline, Medtronic, Merck, Pfizer, Portola, and Sanofi and receiving grants from Bristol Myers Squibb, GlaxoSmithKline, Medtronic, Pfizer, and Sanofi. No other disclosures were reported. Funding/Support: This work was supported by contracts 200-2012-53709 (Boston Medical Center), 200-2012-53661 (Cincinnati Children’s Hospital Medical Center), 200-2012-53663 (Duke University), and 200-2012-50430 (Vanderbilt University Medical Center) with the US Centers for Disease Control and Prevention (CDC) Clinical Immunization Safety Assessment Project. Role of the Funder/Sponsor: The CDC provided funding via the Clinical Immunization Safety Assessment Project to Drs Creech, Edwards, Soslow, Dendy, Schlaudecker, Lang, Barnett, Ruberg, Smith, Campbell, and Lopes. The authors affiliated with the CDC along with the other coauthors conducted the investigations; performed collection, management, analysis, and interpretation of the data; were involved in the preparation, review, and approval of the manuscript; and made the decision to submit the manuscript for publication. Disclaimer: The findings and conclusions in this article are those of the authors and do not necessarily represent the official position of the CDC or the US Food and Drug Administration. Mention of a product or company name is for identification purposes only and does not constitute endorsement by the CDC or the US Food and Drug Administration. Additional Contributions: We thank the following CDC staff who contributed to this article without compensation outside their normal salaries (in alphabetical order and contribution specified in parenthesis at end of each list of names): Nickolas Agathis, MD, MPH, Stephen R. Benoit, MD, MPH, Beau B. Bruce, MD, PhD, Abigail L. Carlson, MD, MPH, Meredith G. Dixon, MD, Jonathan Duffy, MD, MPH, Charles Duke, MD, MPH, Charles Edge, MSN, MS, Robyn Neblett Fanfair, MD, MPH, Nathan W. Furukawa, MD, MPH, Gavin Grant, MD, MPH, Grace Marx, MD, MPH, Maureen J. Miller, MD, MPH, Pedro Moro, MD, MPH, Meredith Oakley, DVM, MPH, Kia Padgett, MPH, BSN, RN, Janice Perez-Padilla, MPH, BSN, RN, Robert Perry, MD, MPH, Nimia Reyes, MD, MPH, Ernest E. Smith, MD, MPH&TM, David Sniadack, MD, MPH, Pamela Tucker, MD, Edward C. Weiss, MD, MPH, Erin Whitehouse, PhD, MPH, RN, Pascale M. Wortley, MD, MPH, and Rachael Zacks, MD (for clinical investigations and interviews); Amelia Jazwa, MSPH, Tara Johnson, MPH, MS, and Jamila Shields, MPH (for project coordination); Charles Licata, PhD, and Bicheng Zhang, MS (for data acquisition and organization); Charles E. Rose, PhD (for statistical consultation); and Scott D. Grosse, PhD (for calculation of expected rates of myocarditis). We also thank the clinical staff who cared for these patients and reported the adverse events to the Vaccine Adverse Event Reporting System. References 1. Cooper LT Jr. Myocarditis. N Engl J Med. 2009;360(15):1526-1538. doi:10.1056/NEJMra0800028PubMedGoogle ScholarCrossref 2. 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