In-Depth Evaluation of a Case of Presumed Myocarditis After the Second Dose of COVID-19 mRNA Vaccine

Muthukumar, Alagarraju; Narasimhan, Madhusudhanan; Li, Quan Zhen; Mahimainathan, Lenin; Hitto, Imran; Fuda, Franklin; Batra, Kiran; Jiang, Xuan; Zhu, Chengsong; Schoggins, John W.; Cutrell, James B; Croft, Carol L.; Khera, Amit; Drazner, Mark H.; Grodin, Justin L.; Greenberg, Benjamin; Mammen, Pradeep P.A.; Morrison, Sean J.; Lemos, James A. de

doi:10.1161/circulationaha.121.056038

Cited by 115 publications

(121 citation statements)

References 38 publications

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“…Anaphylaxis after COVID-19 mRNA vaccination has been observed more commonly than the estimated 1 to 2 cases per million doses reported after receipt of influenza vaccine and some other vaccines. 25 Estimated anaphylaxis incidence rates after receipt of both BNT162b2 and mRNA-1273 vaccines in this study were similar to rates after receipt of mRNA vaccines in other reports, 21,26 although somewhat higher than VAERS estimated reporting rates. 27 In contrast, estimated anaphylaxis incidence rates were much lower than the 24.7 cases of con-firmed anaphylaxis per 100 000 vaccinees estimated through prospective surveillance of health care workers.…”

Section: Discussionsupporting

confidence: 82%

“…This current surveillance complements other vaccine safety monitoring systems in the US, including the Vaccine Adverse Event Reporting System (VAERS) and v-safe. 21 Key strengths of this surveillance are that it is population based, geographically diverse, and updated weekly. Outcome incidence among vaccinees in a risk interval was compared with outcome incidence among similar vaccinees who were in their comparison interval on the same calendar date.…”

Section: Discussionmentioning

confidence: 99%

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Surveillance for Adverse Events After COVID-19 mRNA Vaccination

Klein

Lewis

Goddard

et al. 2021

JAMA

521

502

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IMPORTANCE Safety surveillance of vaccines against COVID-19 is critical to ensure safety, maintain trust, and inform policy.OBJECTIVES To monitor 23 serious outcomes weekly, using comprehensive health records on a diverse population. DESIGN, SETTING, AND PARTICIPANTSThis study represents an interim analysis of safety surveillance data from Vaccine Safety Datalink. The 10 162 227 vaccine-eligible members of 8 participating US health plans were monitored with administrative data updated weekly and supplemented with medical record review for selected outcomes from December 14, 2020, through June 26, 2021.EXPOSURES Receipt of BNT162b2 (Pfizer-BioNTech) or mRNA-1273 (Moderna) COVID-19 vaccination, with a risk interval of 21 days for individuals after vaccine dose 1 or 2 compared with an interval of 22 to 42 days for similar individuals after vaccine dose 1 or 2.MAIN OUTCOMES AND MEASURES Incidence of serious outcomes, including acute myocardial infarction, Bell palsy, cerebral venous sinus thrombosis, Guillain-Barré syndrome, myocarditis/pericarditis, pulmonary embolism, stroke, and thrombosis with thrombocytopenia syndrome. Incidence of events that occurred among vaccine recipients 1 to 21 days after either dose 1 or 2 of a messenger RNA (mRNA) vaccine was compared with that of vaccinated concurrent comparators who, on the same calendar day, had received their most recent dose 22 to 42 days earlier. Rate ratios (RRs) were estimated by Poisson regression, adjusted for age, sex, race and ethnicity, health plan, and calendar day. For a signal, a 1-sided P < .0048 was required to keep type I error below .05 during 2 years of weekly analyses. For 4 additional outcomes, including anaphylaxis, only descriptive analyses were conducted.RESULTS A total of 11 845 128 doses of mRNA vaccines (57% BNT162b2; 6 175 813 first doses and 5 669 315 second doses) were administered to 6.2 million individuals (mean age, 49 years; 54% female individuals). The incidence of events per 1 000 000 person-years during the risk vs comparison intervals for ischemic stroke was 1612 vs 1781 (RR, 0.97; 95% CI, 0.87-1.08); for appendicitis, 1179 vs 1345 (RR, 0.82; 95% CI, 0.73-0.93); and for acute myocardial infarction, 935 vs 1030 (RR, 1.02; 95% CI, 0.89-1.18). No vaccine-outcome association met the prespecified requirement for a signal. Incidence of confirmed anaphylaxis was 4.8 (95% CI, 3.2-6.9) per million doses of BNT162b2 and 5.1 (95% CI, 3.3-7.6) per million doses of mRNA-1273. CONCLUSIONS AND RELEVANCEIn interim analyses of surveillance of mRNA COVID-19 vaccines, incidence of selected serious outcomes was not significantly higher 1 to 21 days postvaccination compared with 22 to 42 days postvaccination. While CIs were wide for many outcomes, surveillance is ongoing.

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Section: Discussionsupporting

confidence: 82%

Section: Discussionmentioning

confidence: 99%

Surveillance for Adverse Events After COVID-19 mRNA Vaccination

Klein

Lewis

Goddard

et al. 2021

JAMA

521

502

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“…Other hypothesized mechanisms include induction of anti-idiotype cross-reactive antibody-mediated cytokine expression in the myocardium and the aberrant induction of apoptosis and results in inflammation of myocardium and pericardium. Furthermore, Muthukumar et al conducted detailed immunologic investigation in a 52-year-old man who developed myocarditis three days after receiving the second dose of Moderna mRNA COVID-19 vaccine and found that his antibody responses to 18 different SARS-CoV-2 antigens did not differ (and was lower for some antigens) from vaccinated controls who did not develop complications [22]. The mRNA vaccines can also induce a non-specific innate inflammatory response or a molecular mimicry mechanism between the viral spike protein and an unknown cardiac protein [23].…”

Section: Causal Relation Between Mrna Vaccine and Myocarditis/pericarditismentioning

confidence: 99%

Myocarditis and Pericarditis Following mRNA COVID-19 Vaccination: What Do We Know So Far?

et al. 2021

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This is a cross-sectional study of 29 published cases of acute myopericarditis following COVID-19 mRNA vaccination. The most common presentation was chest pain within 1–5 days after the second dose of mRNA COVID-19 vaccination. All patients had an elevated troponin. Cardiac magnetic resonance imaging revealed late gadolinium enhancement consistent with myocarditis in 69% of cases. All patients recovered clinically rapidly within 1–3 weeks. Most patients were treated with non-steroidal anti-inflammatory drugs for symptomatic relief, and 4 received intravenous immune globulin and corticosteroids. We speculate a possible causal relationship between vaccine administration and myocarditis. The data from our analysis confirms that all myocarditis and pericarditis cases are mild and resolve within a few days to few weeks. The bottom line is that the risk of cardiac complications among children and adults due to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection far exceeds the minimal and rare risks of vaccination-related transient myocardial or pericardial inflammation.

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“…Similarly, the European Medicines Agency (EMA) reports less than a thousand cases of myopericarditis up to June 2021 2 . The cases described in literature usually present with fever, chest pain, and dyspnea, together with changes on the electrocardiogram and cardiac magnetic resonance findings consistent with myocarditis; the symptoms usually resolved rapidly (114)(115)(116)(117)(118)(119)(120). The patients were treated with non-steroidal anti-inflammatory drugs (NSAIDs) only, but, in some cases, required intravenous immune globulin (IVIG) and corticosteroids (114)(115)(116)(117)(118)(119)(120).…”

Section: Cardiovascular Involvement After Covid-19 Vaccinationmentioning

confidence: 99%

“…The cases described in literature usually present with fever, chest pain, and dyspnea, together with changes on the electrocardiogram and cardiac magnetic resonance findings consistent with myocarditis; the symptoms usually resolved rapidly (114)(115)(116)(117)(118)(119)(120). The patients were treated with non-steroidal anti-inflammatory drugs (NSAIDs) only, but, in some cases, required intravenous immune globulin (IVIG) and corticosteroids (114)(115)(116)(117)(118)(119)(120). However, up-to-date, no causal relationship between vaccine administration and myocarditis has been established.…”

Section: Cardiovascular Involvement After Covid-19 Vaccinationmentioning

confidence: 99%

COVID-19 and Heart Failure: From Epidemiology During the Pandemic to Myocardial Injury, Myocarditis, and Heart Failure Sequelae

Italia

Tomasoni

Bisegna

et al. 2021

Front. Cardiovasc. Med.

106

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A close and intriguing relationship has been suggested between heart failure (HF) and coronavirus disease 2019 (COVID-19). First, COVID-19 pandemic represented a global public health emergency in the last year and had a catastrophic impact on health systems worldwide. Several studies showed a reduction in HF hospitalizations, ranging from 30 to 66% in different countries and leading to a subsequent increase in HF mortality. Second, pre-existing HF is a risk factor for a more severe clinical course of COVID-19 and an independent predictor of in-hospital mortality. Third, patients hospitalized for COVID-19 may develop both an acute decompensation of chronic HF and de-novo HF as a consequence of myocardial injury and cardiovascular (CV) complications. Myocardial injury occurred in at least 10% of unselected COVID-19 cases and up to 41% in critically ill patients or in those with concomitant CV comorbidities. Few cases of COVID-19-related acute myocarditis, presenting with severe reduction in the left ventricular (LV) ejection fraction and peculiar histopathological findings, were described. However, recent data suggested that COVID-19 may be associated with both systolic and diastolic LV dysfunction, with LV diastolic impairment, pulmonary hypertension, and right ventricular dysfunction representing the most frequent findings in echocardiographic studies. An overview of available data and the potential mechanisms behind myocardial injury, possibly leading to HF, will be presented in this review. Beyond the acute phase, HF as a possible long-term consequence of cardiac involvement in COVID-19 patients has been supposed and need to be investigated yet.

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In-Depth Evaluation of a Case of Presumed Myocarditis After the Second Dose of COVID-19 mRNA Vaccine

Abstract: Supplemental Digital Content is available in the text.

Cited by 115 publications

References 38 publications

Surveillance for Adverse Events After COVID-19 mRNA Vaccination

Surveillance for Adverse Events After COVID-19 mRNA Vaccination

Myocarditis and Pericarditis Following mRNA COVID-19 Vaccination: What Do We Know So Far?

COVID-19 and Heart Failure: From Epidemiology During the Pandemic to Myocardial Injury, Myocarditis, and Heart Failure Sequelae

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