Myocarditis and pericarditis after immunization: Gaining insights through the Vaccine Adverse Event Reporting System

Mei, Riccardo; Raschi, Emanuel; Forcesi, Emanuele; Diemberger, Igor; Ponti, Fabrizio De; Poluzzi, Elisabetta

doi:10.1016/j.ijcard.2018.09.054

Cited by 82 publications

(94 citation statements)

References 16 publications

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“…Post-vaccination myocarditis has been reported, most notably after the smallpox vaccine, 15 with a prospective study suggesting a relative risk of clinical myopericarditis of greater than 200-times higher than published background rate. 16 Cases have also been reported after the influenza, tetanus, human papillomavirus, and hepatitis B vaccines, among others 17 ; however, the association is not as strong as with that of the smallpox vaccine. 15 While the pathophysiology of this entity is unclear, limited endomyocardial biopsy and autopsy case reports show lymphocytic and eosinophilic infiltration adjacent to necrotic myositis suggestive of a maladaptive immune-mediated injury or hypersensitivity reaction.…”

Section: Discussionmentioning

confidence: 99%

Acute myocarditis after a second dose of the mRNA COVID-19 vaccine: a report of two cases

et al. 2021

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Section: Discussionmentioning

confidence: 99%

Acute myocarditis after a second dose of the mRNA COVID-19 vaccine: a report of two cases

et al. 2021

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“…Myocarditis as an adverse reaction to the COVID-19 vaccine : In general, myocarditis, is considered an uncommon adverse event following immunization [6] , [7] , [8] . An exception to this generalization is myocarditis following smallpox vaccination in adults with a reported incidence of 1:10,000 [7] , [9] , [10] , [11] , [12] .in a prospective safety surveillance study of perimyocarditis following smallpox vaccine , the authors report that most of the identified cases of perimyocarditis were subclinical and were identified through routine pre and post vaccination troponin level measurments [13] . This finding raises concern that we identified only the “tip of the icberg” i.e.…”

Section: Discussionmentioning

confidence: 99%

Myocarditis following COVID-19 mRNA vaccination

Mouch

Roguin

Hellou

et al. 2021

Vaccine

246

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Background Clinical trials of the BNT162b2 vaccine, revealed efficacy and safety. We report six cases of myocarditis, which occurred shortly after BNT162b2 vaccination. Methods Patients were identified upon presentation to the emergency department with symptoms of chest pain/discomfort. In all study patients, we excluded past and current COVID-19. Routine clinical and laboratory investigations for common etiologies of myocarditis were performed. Laboratory tests also included troponin and C- reactive protein levels.The diagnosis of myocarditis was established after cardiac MRI. Findings Five patients presented after the second and one after the first dose of the vaccine. All patients were males with a median age of 23 years. Myocarditis was diagnosed in all patients.there was no evidence of COVID-19 infection. Laboratory assays excluded concomitant infection; autoimmune disorder was considered unlikely. All patients responded to the BNT162b2 vaccine. The clinical course was mild in all six patients. Interpretation Our report of myocarditis after BNT162b2 vaccination may be possibly considered as an adverse reaction following immunization. We believe our information should be interpreted with caution and further surveillance is warranted.

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“…(1) Reports for individuals receiving any type of vaccine against the influenza virus categorized as suspect AEFI submitted to VAERS (from July 1990 to September 2020) and VigiBase ® (from inception to October 2020) were selected. (2) Cases of myocarditis or pericarditis were extracted through specific PTs and lowest level terms, in line with previous studies on the influenza vaccination [4] and the potential immune-related basis of cardiotoxicity documented for ICIs by recent pharmacovigilance analyses [9,10]: myocarditis, pericarditis, immune-mediated myocarditis, and myopericarditis. (3) Reports recording AEs of interest were finally assessed for co-reported drugs/vaccines of interest.…”

Section: Data Extraction and Analysismentioning

confidence: 99%

“…Therefore, potential interactions between influenza vaccines and drugs used for chronic diseases (e.g., immunosuppressive agents) cannot be excluded [3]. Moreover, cases of myo-pericarditis (MP) after immunization, although rarely, are reported [4,5].…”

Section: Introductionmentioning

confidence: 99%

“…Myocarditis and pericarditis represent serious and life-threatening inflammatory diseases involving myocardium and pericardium, potentially associated with the use of several drugs and vaccines [6][7][8]. In particular, cases of MP were described with the smallpox vaccine in early 2000 and, more recently, very rarely are reported after influenza immunization [4,5]. Immune checkpoint inhibitors (ICIs), such as anti-PD1, anti-PDL1, and anti-CTLA4 monoclonal antibodies, are approved as first-line agents in the management of melanoma and non-small cell lung cancer.…”

Section: Introductionmentioning

confidence: 99%

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Influenza Vaccination and Myo-Pericarditis in Patients Receiving Immune Checkpoint Inhibitors: Investigating the Likelihood of Interaction through the Vaccine Adverse Event Reporting System and VigiBase

et al. 2021

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Background: Evidence on whether the influenza vaccine could exacerbate immune-related adverse events, including myopericarditis (MP), in patients treated with immune checkpoint inhibitors (ICIs), is still conflicting. We explored this issue through a global real-world approach. Methods: We queried the Vaccine Adverse Event Reporting System (VAERS) and VigiBase to retrieve cases of MP in which the influenza vaccine and ICIs were recorded as suspect and were concomitantly reported. For the included cases, causality assessment and Drug Interaction Probability Scale (DIPS) algorithms were applied. Results: There were 191 and 399 reports of MP with the influenza vaccine that were retrieved (VAERS and VigiBase, respectively). No case of MP reporting the concomitant use of ICIs and the influenza vaccine was found in VAERS, while three cases of myocarditis were retrieved in VigiBase. All of the cases were unclassifiable for a causality assessment because of the lack of data concerning latency. According to the DIPS, one report was categorized as possible and two as doubtful. Conclusion: The paucity of cases coupled with the doubtful causality assessment make the potential interaction between influenza vaccines and ICIs in cancer patients negligible from clinical and epidemiological standpoints. These findings support the cardiovascular safety of the influenza vaccination, which remains strongly recommended in cancer patients, especially in the current COVID-19 era.

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Myocarditis and pericarditis after immunization: Gaining insights through the Vaccine Adverse Event Reporting System

Cited by 82 publications

References 16 publications

Acute myocarditis after a second dose of the mRNA COVID-19 vaccine: a report of two cases

Acute myocarditis after a second dose of the mRNA COVID-19 vaccine: a report of two cases

Myocarditis following COVID-19 mRNA vaccination

Influenza Vaccination and Myo-Pericarditis in Patients Receiving Immune Checkpoint Inhibitors: Investigating the Likelihood of Interaction through the Vaccine Adverse Event Reporting System and VigiBase

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