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Cited by 125SARS-CoV-2 and COVID-19 ResearchPharmacovigilance and Adverse Drug ReactionsCOVID-19 Clinical Research Studies

Cardiovascular Adverse Events Reported from COVID-19 Vaccines: A Study Based on WHO Database

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Kaur, Rimple, Dutta, Siddhartha, Charan, Jaykaran, Bhardwaj, Pankaj, Tandon, Ankita, Yadav, Dharamveer, Islam, Salequl, Haque, Mainul·2021·International Journal of General Medicine
DOI 10.2147/ijgm.s324349PMC PMC8326931
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Abstract

Background: Thirteen COVID-19 vaccines are granted emergency approval. It is crucial to monitor their adverse events post vaccination. The present study focuses on cardiovascular adverse events post-COVID-19 vaccination and aims to determine adverse events with the administered vaccine. Methodology: The cardiovascular (CVS) adverse events were extracted for three broad headings (SOCs) – cardiac disorders, vascular disorders, and investigations. Descriptive statistics were reported in the form of percentage and frequency, and the disproportionality analysis was conducted. Results: For the cardiovascular system, 4863 adverse events (AEs) were reported from BNT162b2 Pfizer, 1222 AstraZeneca, Moderna, and other COVID-19 vaccines. Common adverse events observed with vaccines under study were tachycardia (16.41%), flushing (12.17%), hypertension (5.82%), hypotension (3.60%) and peripheral coldness (2.41%). Based on disproportionality analysis (IC 025 values), acute myocardial infarction, cardiac arrest, and circulatory collapse were linked to the vaccines in the age group > 75 years. Hypertension, severe hypertension, supraventricular tachycardia, sinus tachycardia, and palpitations were associated across all age groups and either gender. Amongst the investigations, abnormal ECG findings raised C-reactive protein, elevated D dimer, and troponin were reported in specific age groups or gender or all subjects. Conclusion: Although cardiovascular events have been reported with the COVID-19 vaccines, the causality is yet to be established because such CVS AEs are also usually associated with the general public even without intervention. Hence, people should be administered these vaccines, and sustained monitoring of these AEs should be done. Keywords: adverse events, COVID-19 vaccines, cardiovascular adverse events, Moderna, BNT162b2, 1222 AstraZeneca

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  • Using data from three postmarketing safety databases for vaccines (VAERS, EudraVigilance, and VigiBase), disproportionality studies have reported excess risks for many of the same SAE types as in the present study.

    “Using data from three postmarketing safety databases for vaccines (VAERS, EudraVigilance, and VigiBase), disproportionality studies have reported excess risks for many of the same SAE types as in the present study. [21-23]”

    From Serious adverse events of special interest following mRNA COVID-19 vaccination in randomized trials in adults (2022) · cites this paper as [23]

    The Methodology and Table 3 report a VigiBase disproportionality analysis with elevated reporting measures for several cardiovascular events, including acute myocardial infarction and cardiac arrest. But the Conclusion cautions that these signals may reflect events expected in the vaccinated population and require review for causality; they do not establish excess risk. This source uses VigiBase, not all three databases named across the citing sentence. (LLM, conf=0.85)

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Research works printed but not linked: 4

  1. [19]Dutta S, Kaur RJ, Charan J, et al. Serious adverse events reported from the COVID-19 vaccines: a descriptive study based on WHO database. medRxiv. 2021. doi: 10.1101/2021.03.23.21253433 PMC8326931 34349544 · DOI
  2. [42]Virani SS, Alonso A, Aparicio HJ, et al. Heart disease, and stroke statistics-2021 update: a report from the American Heart Association. Circulation. 2021; 143(8): e254– e743. doi: 10.1161/cir.0000000000000950 33501848 PMC13036842 · DOI · Paper page
  3. [44]Huxley RR, Lopez FL, Folsom AR, et al. Absolute and attributable risks of atrial fibrillation in relation to optimal and borderline risk factors: the Atherosclerosis Risk in Communities (ARIC) study. Circulation. 2011; 123(14): 1501– 1508. doi: 10.1161/circulationaha.110.009035 21444879 PMC3181498 · DOI · Paper page
  4. [50]Quer G, Gadaleta M, Radin JM, et al. The physiologic response to COVID-19 vaccination. he physiologic response to COVID-19 vaccination. medRxiv [Preprint]. 2021. doi: 10.1101/2021.05.03.21256482 · DOI

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Authors
Kaur, R., Dutta, S., Charan, J., Bhardwaj, P., Tandon, A., Yadav, D., Islam, S., & Haque, M.
Affiliations
  • All India Institute of Medical Sciences Jodhpur (IN)
  • Rajendra Institute of Medical Sciences (IN)
  • Jahangirnagar University (BD)
  • National Defence University of Malaysia (MY)
Corresponding author
Charan, Jaykaran
ORCID
Venue
International Journal of General Medicine
Publisher
Informa UK Limited
Published
2021-07
Volume
Volume 14
Pages
3909-3927
ISSN
1178-7074 (ISSN-L)
DOI
10.2147/ijgm.s324349
PMC
PMC8326931
OpenAlex
W3184002959
Cited by
125
References
27
Citations by year
2026: 2 · 2025: 8 · 2024: 26 · 2023: 31 · 2022: 43 · 2021: 15
FWCI
9.11
Type
journal article
Language
en
Open access
Licence
Locations
  • International Journal of General Medicine (publishedVersion, cc-by-nc)
  • PubMed Central (publishedVersion, cc-by-nc)
  • PubMed (publishedVersion)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
  • Dove Medical Press (Taylor and Francis Group) (submittedVersion, cc-by-nc)
Topics
  • Health Sciences › Medicine › Infectious Diseases › SARS-CoV-2 and COVID-19 Research
  • Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
  • Health Sciences › Medicine › Infectious Diseases › COVID-19 Clinical Research Studies
Keywords
COVID-19 vaccines, cardiovascular adverse events, myocardial infarction, hypertension, tachycardia, cardiac arrest, cardiovascular collapse, BNT162b2, AstraZeneca, Moderna, vaccine safety, adverse event reporting, disproportionality analysis, electrocardiographic abnormalities, troponin, D-dimer, C-reactive protein

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