Myocarditis and Pericarditis Post-mRNA COVID-19 Vaccination: Insights from a Pharmacovigilance Perspective

Autores
Alami, Abdallah; Villeneuve, Paul J.; Farrell, Patrick J.; Mattison, Donald; Farhat, Nawal; Haddad, Nisrine; Wilson, Kumanan; Gravel, Christopher A.; Crispo, James A. G.; Perez Lloret, Santiago; Krewski, Daniel
Año de publicación
2023
Idioma
inglés
Tipo de recurso
artículo
Estado
versión publicada
Descripción
Concerns remain regarding the rare cardiovascular adverse events, myocarditis and pericarditis (myo/pericarditis), particularly in younger individuals following mRNA COVID-19 vaccination. Our study aimed to comprehensively assess potential safety signals related to these cardiac events following the primary and booster doses, with a specific focus on younger populations, including children as young as 6 months of age. Using the Vaccine Adverse Events Reporting System (VAERS), the United States national passive surveillance system, we conducted a retrospective pharmacovigilance study analyzing spontaneous reports of myo/pericarditis. We employed both frequentist and Bayesian methods and conducted subgroup analyses by age, sex, and vaccine dose. We observed a higher reporting rate of myo/pericarditis following the primary vaccine series, particularly in males and mainly after the second dose. However, booster doses demonstrated a lower number of reported cases, with no significant signals detected after the fourth or fifth doses. In children and young adults, we observed notable age and sex differences in the reporting of myo/pericarditis cases. Males in the 12-17 and 18-24-year-old age groups had the highest number of cases, with significant signals for both males and females after the second dose. We also identified an increased reporting for a spectrum of cardiovascular symptoms such as chest pain and dyspnea, which increased with age, and were reported more frequently than myo/pericarditis. The present study identified signals of myo/pericarditis and related cardiovascular symptoms after mRNA COVID-19 vaccination, especially among children and adolescents. These findings underline the importance for continued vaccine surveillance and the need for further studies to confirm these results and to determine their clinical implications in public health decision-making, especially for younger populations.
Fil: Alami, Abdallah. University of Ottawa; Canadá
Fil: Villeneuve, Paul J.. University of Ottawa; Canadá
Fil: Farrell, Patrick J.. University of Ottawa; Canadá
Fil: Mattison, Donald. University of Ottawa; Canadá
Fil: Farhat, Nawal. University of Ottawa; Canadá
Fil: Haddad, Nisrine. University of Ottawa; Canadá
Fil: Wilson, Kumanan. University of Ottawa; Canadá
Fil: Gravel, Christopher A.. University of Ottawa; Canadá
Fil: Crispo, James A. G.. University of Ottawa; Canadá
Fil: Perez Lloret, Santiago. Pontificia Universidad Católica Argentina "Santa María de los Buenos Aires"; Argentina. Universidad de Buenos Aires; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina
Fil: Krewski, Daniel. University of Ottawa; Canadá
Materia
myocarditis
pericarditis
pharmacovigilance
vaccine safety
Nivel de accesibilidad
acceso abierto
Condiciones de uso
https://creativecommons.org/licenses/by/2.5/ar/
Repositorio
CONICET Digital (CONICET)
Institución
Consejo Nacional de Investigaciones Científicas y Técnicas
OAI Identificador
oai:ri.conicet.gov.ar:11336/235635
Acceder
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network_acronym_str CONICETDig
repository_id_str 3498
network_name_str CONICET Digital (CONICET)
spelling Myocarditis and Pericarditis Post-mRNA COVID-19 Vaccination: Insights from a Pharmacovigilance PerspectiveAlami, AbdallahVilleneuve, Paul J.Farrell, Patrick J.Mattison, DonaldFarhat, NawalHaddad, NisrineWilson, KumananGravel, Christopher A.Crispo, James A. G.Perez Lloret, SantiagoKrewski, Danielmyocarditispericarditispharmacovigilancevaccine safetyhttps://purl.org/becyt/ford/3.2https://purl.org/becyt/ford/3Concerns remain regarding the rare cardiovascular adverse events, myocarditis and pericarditis (myo/pericarditis), particularly in younger individuals following mRNA COVID-19 vaccination. Our study aimed to comprehensively assess potential safety signals related to these cardiac events following the primary and booster doses, with a specific focus on younger populations, including children as young as 6 months of age. Using the Vaccine Adverse Events Reporting System (VAERS), the United States national passive surveillance system, we conducted a retrospective pharmacovigilance study analyzing spontaneous reports of myo/pericarditis. We employed both frequentist and Bayesian methods and conducted subgroup analyses by age, sex, and vaccine dose. We observed a higher reporting rate of myo/pericarditis following the primary vaccine series, particularly in males and mainly after the second dose. However, booster doses demonstrated a lower number of reported cases, with no significant signals detected after the fourth or fifth doses. In children and young adults, we observed notable age and sex differences in the reporting of myo/pericarditis cases. Males in the 12-17 and 18-24-year-old age groups had the highest number of cases, with significant signals for both males and females after the second dose. We also identified an increased reporting for a spectrum of cardiovascular symptoms such as chest pain and dyspnea, which increased with age, and were reported more frequently than myo/pericarditis. The present study identified signals of myo/pericarditis and related cardiovascular symptoms after mRNA COVID-19 vaccination, especially among children and adolescents. These findings underline the importance for continued vaccine surveillance and the need for further studies to confirm these results and to determine their clinical implications in public health decision-making, especially for younger populations.Fil: Alami, Abdallah. University of Ottawa; CanadáFil: Villeneuve, Paul J.. University of Ottawa; CanadáFil: Farrell, Patrick J.. University of Ottawa; CanadáFil: Mattison, Donald. University of Ottawa; CanadáFil: Farhat, Nawal. University of Ottawa; CanadáFil: Haddad, Nisrine. University of Ottawa; CanadáFil: Wilson, Kumanan. University of Ottawa; CanadáFil: Gravel, Christopher A.. University of Ottawa; CanadáFil: Crispo, James A. G.. University of Ottawa; CanadáFil: Perez Lloret, Santiago. Pontificia Universidad Católica Argentina "Santa María de los Buenos Aires"; Argentina. Universidad de Buenos Aires; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; ArgentinaFil: Krewski, Daniel. University of Ottawa; CanadáMultidisciplinary Digital Publishing Institute2023-07info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttp://purl.org/coar/resource_type/c_6501info:ar-repo/semantics/articuloapplication/pdfapplication/pdfhttp://hdl.handle.net/11336/235635Alami, Abdallah; Villeneuve, Paul J.; Farrell, Patrick J.; Mattison, Donald; Farhat, Nawal; et al.; Myocarditis and Pericarditis Post-mRNA COVID-19 Vaccination: Insights from a Pharmacovigilance Perspective; Multidisciplinary Digital Publishing Institute; Journal of Clinical Medicine; 12; 15; 7-2023; 1-222077-0383CONICET DigitalCONICETenginfo:eu-repo/semantics/altIdentifier/doi/10.3390/jcm12154971info:eu-repo/semantics/openAccesshttps://creativecommons.org/licenses/by/2.5/ar/reponame:CONICET Digital (CONICET)instname:Consejo Nacional de Investigaciones Científicas y Técnicas2025-09-03T10:06:46Zoai:ri.conicet.gov.ar:11336/235635instacron:CONICETInstitucionalhttp://ri.conicet.gov.ar/Organismo científico-tecnológicoNo correspondehttp://ri.conicet.gov.ar/oai/requestdasensio@conicet.gov.ar; lcarlino@conicet.gov.arArgentinaNo correspondeNo correspondeNo correspondeopendoar:34982025-09-03 10:06:47.02CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicasfalse
dc.title.none.fl_str_mv Myocarditis and Pericarditis Post-mRNA COVID-19 Vaccination: Insights from a Pharmacovigilance Perspective
title Myocarditis and Pericarditis Post-mRNA COVID-19 Vaccination: Insights from a Pharmacovigilance Perspective
spellingShingle Myocarditis and Pericarditis Post-mRNA COVID-19 Vaccination: Insights from a Pharmacovigilance Perspective
Alami, Abdallah
myocarditis
pericarditis
pharmacovigilance
vaccine safety
title_short Myocarditis and Pericarditis Post-mRNA COVID-19 Vaccination: Insights from a Pharmacovigilance Perspective
title_full Myocarditis and Pericarditis Post-mRNA COVID-19 Vaccination: Insights from a Pharmacovigilance Perspective
title_fullStr Myocarditis and Pericarditis Post-mRNA COVID-19 Vaccination: Insights from a Pharmacovigilance Perspective
title_full_unstemmed Myocarditis and Pericarditis Post-mRNA COVID-19 Vaccination: Insights from a Pharmacovigilance Perspective
title_sort Myocarditis and Pericarditis Post-mRNA COVID-19 Vaccination: Insights from a Pharmacovigilance Perspective
dc.creator.none.fl_str_mv Alami, Abdallah
Villeneuve, Paul J.
Farrell, Patrick J.
Mattison, Donald
Farhat, Nawal
Haddad, Nisrine
Wilson, Kumanan
Gravel, Christopher A.
Crispo, James A. G.
Perez Lloret, Santiago
Krewski, Daniel
author Alami, Abdallah
author_facet Alami, Abdallah
Villeneuve, Paul J.
Farrell, Patrick J.
Mattison, Donald
Farhat, Nawal
Haddad, Nisrine
Wilson, Kumanan
Gravel, Christopher A.
Crispo, James A. G.
Perez Lloret, Santiago
Krewski, Daniel
author_role author
author2 Villeneuve, Paul J.
Farrell, Patrick J.
Mattison, Donald
Farhat, Nawal
Haddad, Nisrine
Wilson, Kumanan
Gravel, Christopher A.
Crispo, James A. G.
Perez Lloret, Santiago
Krewski, Daniel
author2_role author
author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv myocarditis
pericarditis
pharmacovigilance
vaccine safety
topic myocarditis
pericarditis
pharmacovigilance
vaccine safety
purl_subject.fl_str_mv https://purl.org/becyt/ford/3.2
https://purl.org/becyt/ford/3
dc.description.none.fl_txt_mv Concerns remain regarding the rare cardiovascular adverse events, myocarditis and pericarditis (myo/pericarditis), particularly in younger individuals following mRNA COVID-19 vaccination. Our study aimed to comprehensively assess potential safety signals related to these cardiac events following the primary and booster doses, with a specific focus on younger populations, including children as young as 6 months of age. Using the Vaccine Adverse Events Reporting System (VAERS), the United States national passive surveillance system, we conducted a retrospective pharmacovigilance study analyzing spontaneous reports of myo/pericarditis. We employed both frequentist and Bayesian methods and conducted subgroup analyses by age, sex, and vaccine dose. We observed a higher reporting rate of myo/pericarditis following the primary vaccine series, particularly in males and mainly after the second dose. However, booster doses demonstrated a lower number of reported cases, with no significant signals detected after the fourth or fifth doses. In children and young adults, we observed notable age and sex differences in the reporting of myo/pericarditis cases. Males in the 12-17 and 18-24-year-old age groups had the highest number of cases, with significant signals for both males and females after the second dose. We also identified an increased reporting for a spectrum of cardiovascular symptoms such as chest pain and dyspnea, which increased with age, and were reported more frequently than myo/pericarditis. The present study identified signals of myo/pericarditis and related cardiovascular symptoms after mRNA COVID-19 vaccination, especially among children and adolescents. These findings underline the importance for continued vaccine surveillance and the need for further studies to confirm these results and to determine their clinical implications in public health decision-making, especially for younger populations.
Fil: Alami, Abdallah. University of Ottawa; Canadá
Fil: Villeneuve, Paul J.. University of Ottawa; Canadá
Fil: Farrell, Patrick J.. University of Ottawa; Canadá
Fil: Mattison, Donald. University of Ottawa; Canadá
Fil: Farhat, Nawal. University of Ottawa; Canadá
Fil: Haddad, Nisrine. University of Ottawa; Canadá
Fil: Wilson, Kumanan. University of Ottawa; Canadá
Fil: Gravel, Christopher A.. University of Ottawa; Canadá
Fil: Crispo, James A. G.. University of Ottawa; Canadá
Fil: Perez Lloret, Santiago. Pontificia Universidad Católica Argentina "Santa María de los Buenos Aires"; Argentina. Universidad de Buenos Aires; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina
Fil: Krewski, Daniel. University of Ottawa; Canadá
description Concerns remain regarding the rare cardiovascular adverse events, myocarditis and pericarditis (myo/pericarditis), particularly in younger individuals following mRNA COVID-19 vaccination. Our study aimed to comprehensively assess potential safety signals related to these cardiac events following the primary and booster doses, with a specific focus on younger populations, including children as young as 6 months of age. Using the Vaccine Adverse Events Reporting System (VAERS), the United States national passive surveillance system, we conducted a retrospective pharmacovigilance study analyzing spontaneous reports of myo/pericarditis. We employed both frequentist and Bayesian methods and conducted subgroup analyses by age, sex, and vaccine dose. We observed a higher reporting rate of myo/pericarditis following the primary vaccine series, particularly in males and mainly after the second dose. However, booster doses demonstrated a lower number of reported cases, with no significant signals detected after the fourth or fifth doses. In children and young adults, we observed notable age and sex differences in the reporting of myo/pericarditis cases. Males in the 12-17 and 18-24-year-old age groups had the highest number of cases, with significant signals for both males and females after the second dose. We also identified an increased reporting for a spectrum of cardiovascular symptoms such as chest pain and dyspnea, which increased with age, and were reported more frequently than myo/pericarditis. The present study identified signals of myo/pericarditis and related cardiovascular symptoms after mRNA COVID-19 vaccination, especially among children and adolescents. These findings underline the importance for continued vaccine surveillance and the need for further studies to confirm these results and to determine their clinical implications in public health decision-making, especially for younger populations.
publishDate 2023
dc.date.none.fl_str_mv 2023-07
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
http://purl.org/coar/resource_type/c_6501
info:ar-repo/semantics/articulo
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv http://hdl.handle.net/11336/235635
Alami, Abdallah; Villeneuve, Paul J.; Farrell, Patrick J.; Mattison, Donald; Farhat, Nawal; et al.; Myocarditis and Pericarditis Post-mRNA COVID-19 Vaccination: Insights from a Pharmacovigilance Perspective; Multidisciplinary Digital Publishing Institute; Journal of Clinical Medicine; 12; 15; 7-2023; 1-22
2077-0383
CONICET Digital
CONICET
url http://hdl.handle.net/11336/235635
identifier_str_mv Alami, Abdallah; Villeneuve, Paul J.; Farrell, Patrick J.; Mattison, Donald; Farhat, Nawal; et al.; Myocarditis and Pericarditis Post-mRNA COVID-19 Vaccination: Insights from a Pharmacovigilance Perspective; Multidisciplinary Digital Publishing Institute; Journal of Clinical Medicine; 12; 15; 7-2023; 1-22
2077-0383
CONICET Digital
CONICET
dc.language.none.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv info:eu-repo/semantics/altIdentifier/doi/10.3390/jcm12154971
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
https://creativecommons.org/licenses/by/2.5/ar/
eu_rights_str_mv openAccess
rights_invalid_str_mv https://creativecommons.org/licenses/by/2.5/ar/
dc.format.none.fl_str_mv application/pdf
application/pdf
dc.publisher.none.fl_str_mv Multidisciplinary Digital Publishing Institute
publisher.none.fl_str_mv Multidisciplinary Digital Publishing Institute
dc.source.none.fl_str_mv reponame:CONICET Digital (CONICET)
instname:Consejo Nacional de Investigaciones Científicas y Técnicas
reponame_str CONICET Digital (CONICET)
collection CONICET Digital (CONICET)
instname_str Consejo Nacional de Investigaciones Científicas y Técnicas
repository.name.fl_str_mv CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicas
repository.mail.fl_str_mv dasensio@conicet.gov.ar; lcarlino@conicet.gov.ar
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