COVID-19 vaccine-associated myocarditis: Analysis of the suspected cases reported to the EudraVigilance and a systematic review of the published literature
Background: Myocarditis secondary to Coronavirus Disease 2019 (COVID-19) vaccination has been reported in the literature. Objective: This study aimed to characterize the reported cases of myocarditis after COVID-19 vaccination based on age, gender, doses, and vaccine type from published literature a...
| Main Authors: | , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Elsevier
2023-12-01
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| Series: | International Journal of Cardiology: Heart & Vasculature |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2352906723001112 |
| _version_ | 1827591103119884288 |
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| author | Vikash Jaiswal Dattatreya Mukherjee Song Peng Ang Tejasvi Kainth Sidra Naz Abhigan Babu Shrestha Vibhor Agrawal Saloni Mitra Jia Ee Chia Bernd Jilma Mamas A. Mamas Catherine Gebhard Marek Postula Jolanta M. Siller-Matula |
| author_facet | Vikash Jaiswal Dattatreya Mukherjee Song Peng Ang Tejasvi Kainth Sidra Naz Abhigan Babu Shrestha Vibhor Agrawal Saloni Mitra Jia Ee Chia Bernd Jilma Mamas A. Mamas Catherine Gebhard Marek Postula Jolanta M. Siller-Matula |
| author_sort | Vikash Jaiswal |
| collection | DOAJ |
| description | Background: Myocarditis secondary to Coronavirus Disease 2019 (COVID-19) vaccination has been reported in the literature. Objective: This study aimed to characterize the reported cases of myocarditis after COVID-19 vaccination based on age, gender, doses, and vaccine type from published literature and the EudraVigilance database. Methods: We performed an analysis in the EudraVigilance database (until December 18, 2021) and a systematic review of published literature for reported cases of suspected myocarditis and pericarditis (until 30th June 2022) after the COVID-19 vaccination. Results: EudraVigilance database analysis revealed 16,514 reported cases of myocarditis or pericarditis due to the vaccination with COVID-19 vaccines. The cases of myo- or pericarditis were reported predominantly in the age group of 18–64 (n = 12,214), and in males with a male-to-female (M: F) ratio of 1.7:1. The mortality among myocarditis patients was low, with 128 deaths (2 cases per 10.000.000 administered doses) being reported. For the systematic review, 72 studies with 1026 cases of myocarditis due to the vaccination with COVID-19 vaccines were included. The analysis of published cases has revealed that the male gender was primarily affected with myocarditis post-COVID-vaccination. The median (IQR) age of the myocarditis cases was 24.6 [19.5–34.6] years, according to the systematic review of the literature. Myocarditis cases were most frequently published after the vaccination with m-RNA vaccines and after the second vaccination dose. The overall mortality of published cases was low (n = 5). Conclusion: Myocarditis is a rare serious adverse event associated with a COVID-19 vaccination. With early recognition and management, the prognosis of COVID-19 vaccine-induced myocarditis is favorable. |
| first_indexed | 2024-03-09T01:27:03Z |
| format | Article |
| id | doaj.art-165c5673102f4441a112fdea5dc7cbe2 |
| institution | Directory Open Access Journal |
| issn | 2352-9067 |
| language | English |
| last_indexed | 2024-03-09T01:27:03Z |
| publishDate | 2023-12-01 |
| publisher | Elsevier |
| record_format | Article |
| series | International Journal of Cardiology: Heart & Vasculature |
| spelling | doaj.art-165c5673102f4441a112fdea5dc7cbe22023-12-10T06:16:26ZengElsevierInternational Journal of Cardiology: Heart & Vasculature2352-90672023-12-0149101280COVID-19 vaccine-associated myocarditis: Analysis of the suspected cases reported to the EudraVigilance and a systematic review of the published literatureVikash Jaiswal0Dattatreya Mukherjee1Song Peng Ang2Tejasvi Kainth3Sidra Naz4Abhigan Babu Shrestha5Vibhor Agrawal6Saloni Mitra7Jia Ee Chia8Bernd Jilma9Mamas A. Mamas10Catherine Gebhard11Marek Postula12Jolanta M. Siller-Matula13Independent Researcher, IndiaRaiganj Government Medical College and Hospital, IndiaDepartment of Internal Medicine, Rutgers Health Community Medical Center, Toms River, NJ, USADepartment of Psychiatry, Bronxcare Health System, NY, USADepartment of Internal Medicine, Harvard Medical School/BIDMC, Boston, USADepartment of Medicine, M Abdur Rahim Medical College, Dinajpur, BangladeshKing George’s Medical University, Lucknow, IndiaOO Bogomolets National Medical University, Kyiv, UkraineDepartment of Internal Medicine, Texas Tech University Health Sciences, El Paso, TX, USADepartment of Clinical Pharmacology, Medical University of Vienna, AustriaKeele Cardiovascular Research Group, Keele University, Keele, UKDepartment of Cardiology, Inselspital, Bern University Hospital, SwitzerlandDepartment of Experimental and Clinical Pharmacology, Medical University of Warsaw, Center for Preclinical Research and Technology CEPT, Warsaw, PolandDepartment of Cardiology, Medical University of Vienna, Austria; Corresponding author at: Department of Internal Medicine II, Division of Cardiology, Medical University of Vienna, Waehringer Guertel 18-20, A-1090 Vienna, Austria.Background: Myocarditis secondary to Coronavirus Disease 2019 (COVID-19) vaccination has been reported in the literature. Objective: This study aimed to characterize the reported cases of myocarditis after COVID-19 vaccination based on age, gender, doses, and vaccine type from published literature and the EudraVigilance database. Methods: We performed an analysis in the EudraVigilance database (until December 18, 2021) and a systematic review of published literature for reported cases of suspected myocarditis and pericarditis (until 30th June 2022) after the COVID-19 vaccination. Results: EudraVigilance database analysis revealed 16,514 reported cases of myocarditis or pericarditis due to the vaccination with COVID-19 vaccines. The cases of myo- or pericarditis were reported predominantly in the age group of 18–64 (n = 12,214), and in males with a male-to-female (M: F) ratio of 1.7:1. The mortality among myocarditis patients was low, with 128 deaths (2 cases per 10.000.000 administered doses) being reported. For the systematic review, 72 studies with 1026 cases of myocarditis due to the vaccination with COVID-19 vaccines were included. The analysis of published cases has revealed that the male gender was primarily affected with myocarditis post-COVID-vaccination. The median (IQR) age of the myocarditis cases was 24.6 [19.5–34.6] years, according to the systematic review of the literature. Myocarditis cases were most frequently published after the vaccination with m-RNA vaccines and after the second vaccination dose. The overall mortality of published cases was low (n = 5). Conclusion: Myocarditis is a rare serious adverse event associated with a COVID-19 vaccination. With early recognition and management, the prognosis of COVID-19 vaccine-induced myocarditis is favorable.http://www.sciencedirect.com/science/article/pii/S2352906723001112COVID-19 vaccinemRNA vaccineMyocarditisMyopericarditis |
| spellingShingle | Vikash Jaiswal Dattatreya Mukherjee Song Peng Ang Tejasvi Kainth Sidra Naz Abhigan Babu Shrestha Vibhor Agrawal Saloni Mitra Jia Ee Chia Bernd Jilma Mamas A. Mamas Catherine Gebhard Marek Postula Jolanta M. Siller-Matula COVID-19 vaccine-associated myocarditis: Analysis of the suspected cases reported to the EudraVigilance and a systematic review of the published literature International Journal of Cardiology: Heart & Vasculature COVID-19 vaccine mRNA vaccine Myocarditis Myopericarditis |
| title | COVID-19 vaccine-associated myocarditis: Analysis of the suspected cases reported to the EudraVigilance and a systematic review of the published literature |
| title_full | COVID-19 vaccine-associated myocarditis: Analysis of the suspected cases reported to the EudraVigilance and a systematic review of the published literature |
| title_fullStr | COVID-19 vaccine-associated myocarditis: Analysis of the suspected cases reported to the EudraVigilance and a systematic review of the published literature |
| title_full_unstemmed | COVID-19 vaccine-associated myocarditis: Analysis of the suspected cases reported to the EudraVigilance and a systematic review of the published literature |
| title_short | COVID-19 vaccine-associated myocarditis: Analysis of the suspected cases reported to the EudraVigilance and a systematic review of the published literature |
| title_sort | covid 19 vaccine associated myocarditis analysis of the suspected cases reported to the eudravigilance and a systematic review of the published literature |
| topic | COVID-19 vaccine mRNA vaccine Myocarditis Myopericarditis |
| url | http://www.sciencedirect.com/science/article/pii/S2352906723001112 |
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