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 different vaccines, various thrombotic events have been reported. Yet, a comprehensive analysis of vaccine-associated stroke and other thrombotic events is not well-characterized. Methods: We utilized the vaccine adverse event reporting system (VAERS) database from 1990-2021 to examine the association between vaccines and thrombotic events. We analyzed the data by sex and age, and vaccine type, and COVID-19 vaccine manufacturer. Disproportionality signal analysis was conducted by measuring reporting odds ratio (ROR) with a 95% confidence interval (CI). Results: Out of over 1.3 million adverse events reported in VAERS, more than 6000 were strokes between 1990-2021. Most strokes (70%) COVID-19 vaccines accounted for over 80% of all vaccine-related strokes with ROR (CI 95%) of 13.3 (CI 12.4-14.3, p<0.0001). Among COVID-19 vaccines, Pfizer/Biotech was associated with 46%, Moderna with 40%, and Janssen with 12% of strokes. Finally, our data revealed that prothrombic diseases of various vascular territories were reported the most among patients who have received COVID-19 vaccines with ROR (CI 95%) of 19.32 (CI 18.17-20.54; p <0.0001). Among these thrombotic events myocardial infarction, pulmonary embolism, and deep vein thrombosis were the most predominant. Conclusion: Our data suggest a link between COVID-19 vaccines and thrombotic events, especially strokes. This retrospective study highlights the urgent need for further longitudinal studies to examine the safety of vaccines in patients with high risk for thrombosis.

Background: Multiple myeloma accounts for over 15% of hematological malignancies. In attempt to tackle this malady, the FDA approved four drugs in 2015 which has propagated further development of new anti-multiple myeloma since. However, the health safety of these new agents is still ill-defined. The aim of this study is to delineate the cardiovascular adverse events of these drugs. Methods: We searched the cardiac adverse events of the newly approved FDA drugs since 2015 using the U.S. Food and Drug Administration Adverse Events Reporting System database (FAERS). We calculated the reporting odds ratio (ROR) with 95% confidence for four drugs that have the highest incidence of cardiovascular adverse events. Results: Among the medications that have approved for MM Between 2015-2020, four novel drugs showed the highest incidence of cardiotoxicity. ROR (95% CI) for atrial fibrillation due to elotuzumab, Ixazomib, daratumumab, and panobinostat compared to other FAERS drugs was 5.8 (4.4-7.7), 1.9 (1.5-2.3), 4.8 (4.2-5.6), and 5.7 (4.1-8.1), respectively. The ROR (95% CI) for cardiac failure was 8.2 (6.4-10.5), 4.7 (4.1-5.4), 5.8 (4.9-6.7), and 5.6 (3.8-8.1) and ROR (95% CI) for coronary disease was 2.7 (1.9-3.9), 2.7 (2.3-3.2), 2.3 (1.9-2.8), and 4.6 (3.2-6.6) due to elotuzumab, Ixazomib, daratumumab, and panobinostat versus all other drugs in FAERS. Conclusions: Our results demonstrated that the newly approved antimyeloma therapy (elotuzumab, Ixazomib, daratumumab, panobinostat) are significantly associated previously unknow cardiotoxicity. These results warrant further studies and highlight the importance of considering the cardiac history of patients with multiple myeloma when utilizing these novel agents.

Background: Emerging novel therapeutics have been developed to hamper the progression of multiple sclerosis. However, the adverse events related to these new agents remain largely unknown. Therefore, we sought to investigate the cardiovascular complications of these drugs. Methods: Utilizing data from the U.S. Food and Drug Administration Adverse Events Reporting System, we comprehensively evaluated the cardiovascular complications of the newly FDA approved anti-multiple sclerosis agents. Disproportionality signal analysis was conducted by measuring reporting odds ratio (ROR) with 95% confidence interval of all the cardiovascular adverse events adverse events since approval till 2021. Results: After vetting the newly approved agents for multiple sclerosis, CD20 and CD25 inhibitors and sphingosine-1-phosphate receptors agonists were the latest approved medications for multiple sclerosis since 2015. Two CD20 (ocrelizumab, ofatumumab) and one CD25 inhibitors (daclizumab) were significantly associated with multiple cardiovascular adverse events. Among all the cardiotoxic events; coronary artery disease, cardiac failure and atrial fibrillation were the most predominant among CD20 or CD25 blockers. Interestingly, Sphingosine-1-phosphate receptors agonists showed much fewer reported cardiac adverse events. However, fingolimod and siponimod were associated with significant bradycardia. Conclusions: Our data revealed the new agents prescribed for multiple sclerosis have cardiotoxic effects, including not only the known adverse effects observed effects for S1P receptor modulators but also undefined cardiovascular complications associated with CD20 and CD25 inhibitors. These findings potentially instigate further studies to personalize prescribing these agents for multiple sclerosis based on patient’s cardiovascular profile.

Introduction: 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 cases of takotsubo cardiomyopathy and COVID-19 vaccine have been described, a comprehensive study to investigate the role of vaccination with cardiomyopathy and heart failure is lacking. The aim of this study is to investigate the link between the current vaccines and heart failure. Method: 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 21.6 (CI: 18.3 to 25.4, P<0.0001). Smallpox was also significant with ROR 7.2 (CI 5.5-9.6, P<0.0001) On the other hand, heart failure was minimally described to be associated with other vaccines (influenza, zoster, tetanus, human papillomavirus (PPV)). Conclusions: Our study showed for the first time that vaccines maybe associated with heart failure. In particular, we show that covid-19 and smallpox vaccines are associated with increased risk of heart failure. Vaccines against Influenza, zoster, tetanus and (PPV) are associated with reduced heart failure. These data warrant longitudinal studies to delineate the association between heart failure and vaccines.

Aim: 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 its effects on heart rhythm disorders. Methods: we used vaccine adverse event reporting system (VAERS) between 1990-2021 to search for atrial fibrillation and other less prevalent arrhythmia. 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 13.18 (CI 95%: 11.3 to 15.4) (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. Finally, our analysis showed that COVID-19 vaccines were associated with much higher incidence of other cardiac arrhythmias compared with other vaccines. Conclusions: While vaccines have not been linked to heart rhythm disorders, the introduction of COVID-19 vaccines in 2020 showed significant association with atrial fibrillation. This study showed unprecedent detrimental effect of COVID-19 vaccines on atrial fibrillation and warrants the need to take that into consideration when prescribing COVID-19 vaccines.