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.

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.