ABSTRACT
Background Vaccines are considered one of the milestones of modern medicine that promoted health and curbed morbidity and mortality. However, with the rapid development and approval of various vaccines, various thrombotic events have been reported. Yet, a comprehensive analysis of vaccine and stroke and other thrombotic events is not well-characterized. Methods To investigate the relationship between vaccines and thrombotic disorders, we utilized vaccine adverse event reporting system (VAERS) database between 1990-2021 using key medical terms. The data was stratified based on sex and age, and type of vaccine. The COVID-19 vaccine was additionally stratified based on manufacturer. Disproportionality signal analysis was conducted by measuring reporting odds ratio (ROR) with 95% confidence interval (CI). Results More than 1,300,000 adverse events reported between 1990-2021 in FAERS database. Over 6000 cases of stroke have been reported between 1990-2021. As expected, most of the reported stroke (70%) occurred in older patients (>50 years old). Interestingly, the incidence of vaccine-associated stroke is slightly more in females (52%) compared to males (44%). Among all the vaccine-related stoke, COVID-19 vaccines were associated with over 80% of all stroke reported with ROR (CI 95%) of 13.3 (CI 12.4-14.3, p<0.0001). Subclassification analysis of COVID-19 vaccines revealed that Pfizer/Biontech COVID-19 vaccine was associated with 46%, Moderna (40%), and Janssen (12%) of all COVID-19 associated stroke. Finally, our data revealed that prothrombic diseases of various vascular beds were reported the most among patients who have received COVID-19 vaccines. Among these thrombotic events, deep vein thrombosis, pulmonary embolism, and cerebral venous sinus thrombosis were the most predominant. Conclusion Thrombotic events related to vaccines are rare but still feared due to their high morbidity and mortality. In this study, ischemic stroke was most reported among the COVID-19, Zoster, and Influenza trivalent injected vaccine. This retrospective study highlights the urgent need for further longitudinal studies to examine the safety of vaccines in patient with high risk for thrombosis.Copyright © 2023 American College of Cardiology Foundation
ABSTRACT
Background: The role of vaccines in preventing diseases is well-established. However, the evolving techniques and types of vaccine necessitate the search for its safety more than ever. While previous case reports described an association between Takotsubo (stress) cardiomyopathy and COVID-19 vaccine, a comprehensive study to investigate the role of vaccination with cardiomyopathy and heart failure is lacking. The aim of this study is to study if there is a link between the current vaccines and cardiomyopathy/heart failure. Methods: We utilized vaccine adverse event reporting system (VAERS) to search for cardiomyopathy, cardiac failure or ventricular dysfunction. Disproportionality signal analysis was conducted by measuring reporting odds ratio (ROR) with 95% confidence interval (CI). Results: VAERS reported over 1,300,000 adverse events between 1990-2021. Heart failure was reported over 2000 times in association with multiple vaccines. 56% of vaccine-related heart failure reported in males;88% were serious;19% mortality rate. The majority of reported heart failure was related to COVID-19 vaccines with ROR of 3.0518 (CI: 2.7590 to 3.3756, P<0.0001). On the other hand, heart failure was minimally described to be associated with other vaccines (influenza, zoster, tetanus, human papillomavirus⋯etc). Conclusion: Over the last decades, vaccines rarely reported to be associated with heart failure. However, the introduction of COVID-19 vaccines showed significant association with the incidence of heart failure and cardiomyopathy. Further studies are needed to investigate the molecular mechanisms of vaccine-related cardiomyopathy/heart failure. Additionally, our results showed that physician may need to stratify the patient’s risk of heart failure before giving COVID-19 vaccine.
ABSTRACT
Background: Vaccines have been mainly described to provide cardioprotective effects with rare reports showing rare association with myopericarditis. However, vaccines have not been well-studied regarding their effects on heart rhythm disorders. Methods: We used the Food and Drug Administration (FDA) Vaccine Adverse Event Reporting System (VAERS) between 1990-2021 to search for atrial fibrillation and other less prevalent arrhythmias. Disproportionality signal analysis was conducted by measuring reporting odds ratio (ROR) with 95% confidence interval (CI). Results: Over 1,300,000 adverse events were reported between 1990-2021. Among these events, atrial fibrillation was reported 2149 times in association with various vaccines. 90% of atrial fibrillation was associated with COVID-19 vaccines with ROR of 9.7739 (CI: 8.3703 to 11.4130) (P<0.0001). Interestingly, influenza vaccines, polyvalent polysaccharide pneumococcal (PPSV23) vaccine, pneumococcal 13-valent (PCV13) vaccine, zoster vaccine, and tetanus-containing vaccines were significantly associated with reduced atrial fibrillation. Of note, deaths were predominantly within the 50-year-old and above age group. Conclusion: While vaccines have not been linked to heart rhythm disorders, the introduction of COVID-19 vaccines in 2020 showed a significant association with atrial fibrillation. This study showed an unprecedented detrimental effect of COVID-19 vaccines on atrial fibrillation and warrants the need to take that into consideration when prescribing COVID-19 vaccines.