Acute myocarditis following a third dose of COVID-19 mRNA vaccination in adults

Simone, Anthony; Herald, John; Chen, Aiyu; Nayak, Rohith; Shen, Yuh-Jer; Lee, Ming‐Sum

doi:10.1016/j.ijcard.2022.07.031

Cited by 17 publications

(28 citation statements)

References 7 publications

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“…However, further unknown side effects of these vaccines need to be investigated through the development of further studies that continue to investigate the existence of causality between COVID-19 vaccines and the reported adverse events. Finally, it is noteworthy that the occurrence of cardiac side effects and the reported adverse reactions have been matched by case reports published in the literature [ 34 ].…”

Section: Discussionsupporting

confidence: 60%

COVID-19 mRNA Vaccines: A Retrospective Observational Pharmacovigilance Study

Ferrara¹,

Mancaniello²,

Varriale³

et al. 2022

Clin Drug Investig

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Background and Objective Coronavirus disease 2019 (COVID-19) caused by the SARS-CoV-2 virus has caused millions of deaths worldwide. The mRNA vaccines prevented the figure from being more severe. The objective of this retrospective study is to evaluate the safety of COVID-19 vaccines by analyzing the adverse events following immunization (AEFIs). Methods A retrospective observational pharmacovigilance study was conducted, based on the collection of reports of suspected AEFIs reported between 1 January 2021 and 31 December 2021 at the Naples 3 local health authority. AEFIs were stratified and described according to mRNA vaccine, demographics, clinical status, description of AEFI, and degree of severity. In 2021, local health authority Asl Naples 3 South received 1164 reports of suspected adverse events that occurred following the administration of mRNA vaccines. Results During the reporting period, 746 reports were related to the Comirnaty vaccine (64.1%), 281 to the Vaxzevria vaccine (24.1%), 107 to the Spikevax vaccine (9.2%), and 30 to the Jcovden vaccine (2.6%); 89.3% of the reports were classified as not serious ( N = 1039 reports), the remaining 10.7% as serious ( N = 125 reports). Conclusions This retrospective pharmacovigilance study demonstrates that COVID-19 mRNA vaccines are safe in all population groups.

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Section: Discussionsupporting

confidence: 60%

COVID-19 mRNA Vaccines: A Retrospective Observational Pharmacovigilance Study

Ferrara¹,

Mancaniello²,

Varriale³

et al. 2022

Clin Drug Investig

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“…6 Increased risks after the booster dose have also been observed in a French case-control study, in a US cohort of Kaiser Permanente Southern California members and in a Canadian cohort. 5,7,8 In all three studies, the relative risks associated with the booster dose were lower than the relative risks associated with the second dose.…”

Section: Conclusion and Relevancementioning

confidence: 81%

“…[1][2][3][4] Currently available evidence also suggests increased myocarditis risk associated with booster doses. [5][6][7][8] In a self-controlled case series study from the UK, relative risks of 1.72 and 2.64 were observed for the 28-day risk period following a BNT or MOD booster dose vs. reference periods, respectively. 6 These relative risk estimates were lower than those observed for the 28-day period following second doses of BNT and MOD.…”

Section: Conclusion and Relevancementioning

confidence: 99%

Booster Vaccination with SARS-CoV-2 mRNA Vaccines and Myocarditis Risk in Adolescents and Young Adults: A Nordic Cohort Study of 8.9 Million Residents

Hviid

Nieminen

Pihlström

et al. 2022

Preprint

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Importance The SARS-CoV-2 mRNA vaccines are associated with an increased risk of myocarditis. This association appears to be strongest in male adolescents and younger males and after the second dose. Few studies have evaluated the association after booster doses. Objective To evaluate the risk of myocarditis following SARS-CoV-2 mRNA booster vaccination in 12-to-39-year-olds. Design A multinational cohort study using nationwide register data. Setting Denmark, Finland, Norway, and Sweden. Participants Cohorts comprising all 8.9 million individuals residing in each of the four countries, born 1982-2009, and alive at start of study on December 27, 2020, without a previous diagnosis of myocarditis or pericarditis or laboratory-confirmed SARS-CoV-2 infection. Exposures The 28-day acute risk periods following the second and third dose of BNT162b2 and mRNA-1273, respectively, in a homologous schedule defines the exposures of interest. Main Outcomes and Measures Cohort participants were followed until an inpatient diagnosis of myocarditis, loss to follow-up, or end of study (latest data availability in each country), whichever occurred first. In each of the four countries, Poisson regression was used to estimate adjusted incidence rate ratios (IRRs) of myocarditis, with associated 95% confidence intervals (CIs), according to vaccination status. Country-specific results were combined in meta-analyses. Results A total of 8.9 million residents were followed for 12,271,861 person-years. We identified 1533 cases of myocarditis. In 12-to-39-year-old males, the 28-day acute risk period following the third dose of BNT162b2 or mRNA-1273 was associated with an increased incidence rate of myocarditis compared to the post-acute risk period 28 days or more after a second homologous dose (IRR, 2.08 [95% CI, 1.31 to 3.33] and 8.89 [95% CI, 2.26 to 35.03], respectively). The corresponding incidence rates following the third dose of BNT162b2 and mRNA-1273 were 0.86 and 1.95, respectively, within 28 days of follow-up among 100,000 individuals. Conclusions and Relevance Our results suggest that a booster dose is associated with increased myocarditis risk in male adolescents and young male adults.

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“…A few case series of booster-associated myocarditis also demonstrated benign clinical courses. Literature on the case series for COVID-19 booster-associated myocarditis are summarized in Aviram et al 2022;Friedensohn et al 2022;Sharff et al 2022;Shiyovich et al 2022;Simone et al 2022).…”

Section: Discussionmentioning

confidence: 99%

Acute Perimyocarditis in an Adolescent Japanese Male after a Booster Dose of the BNT162b2 COVID-19 Vaccine

Morita

Matsubara

Seki

et al. 2022

Tohoku J. Exp. Med.

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Perimyocarditis is a rare and serious cardiac complication following COVID-19 vaccination.Young males are most at risk after the second dose. With the introduction of the booster (third) dose, some reports have focused on the risk of perimyocarditis after a booster dose. However, no currently available report in Japan has comprehensively described this phenomenon. A healthy 14-year-old Japanese male, who had completed a two-dose primary series of the BNT162b2 (Pfizer-BioNTech) vaccine six months prior, developed fever and chest pain within 24 hours after a homologous booster dose. He was transferred to our institute because of worsening chest pain. A multiplex PCR test showed no evidence of active viral infections, including SARS-CoV-2. Electrocardiography revealed ST-segment elevation in almost all leads, suggesting pericarditis. Echocardiography showed normal systolic function. Laboratory data demonstrated C-reactive protein levels of 8.8 mg/dL and elevated cardiac damage markers (troponin T: 1.9 ng/mL, creatine phosphokinase:1527 U/L, MB isoenzyme: 120 U/L), suggesting myocarditis. He was diagnosed with perimyocarditis associated with the booster dose, which was confirmed by cardiac magnetic resonance imaging four days after initial symptoms. Chest pain improved spontaneously along with a resolution of electrocardiographic findings and laboratory data within several days. He was discharged eight days after admission.Perimyocarditis is less frequent after a booster dose than after primary doses. In this case, the patient with booster-dose-associated perimyocarditis showed favorable clinical course without severe sequelae. The patient's clinical course was consistent with findings on previous largescale reports on primary-dose-associated perimyocarditis and case series on booster-doseassociated perimyocarditis.

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Acute myocarditis following a third dose of COVID-19 mRNA vaccination in adults

Cited by 17 publications

References 7 publications

COVID-19 mRNA Vaccines: A Retrospective Observational Pharmacovigilance Study

COVID-19 mRNA Vaccines: A Retrospective Observational Pharmacovigilance Study

Booster Vaccination with SARS-CoV-2 mRNA Vaccines and Myocarditis Risk in Adolescents and Young Adults: A Nordic Cohort Study of 8.9 Million Residents

Acute Perimyocarditis in an Adolescent Japanese Male after a Booster Dose of the BNT162b2 COVID-19 Vaccine

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