scholarly journals Evaluation of Cardiovascular Safety of COVID19 Vaccines in VAERS

Author(s):  
Matthew Clark

Abstract While COVID19 vaccines have been administered to over 100 million patients, a small minority (40,000) have reported adverse events, and an even smaller fraction have reported cardiovascular issues (~500). There have been reporting of a few unusual cardiovascular events associated with some varieties of COVID19 vaccines resulting in pauses of use. Here we analyze the reports of adverse events associated with the COVID19 vaccines in the FDA Vaccine Adverse Event Reporting System (VAERS) database to apply standard methods of detecting safety signals. In this work we apply this methodology to reports in the FDA VAERS database and have identified concerning signals for pulmonary embolism and myocardial infarction associated with COVID19 vaccines. These signals are compared with cardiovascular events reported in connection with influenza (FLU3) vaccines that are administered to a similar population. While signals of these events are higher for COVID19 than other vaccines, the incidence rates are comparable to the normally expected rate for non-vaccinated individuals.

2021 ◽  
Author(s):  
Matthew Clark

Abstract While COVID19 vaccines have been administered to over 100 million patients, a small minority (40,000) have reported adverse events, and an even smaller fraction have reported cardiovascular issues (~500). There have been reporting of a few unusual cardiovascular events associated with some varieties of COVID19 vaccines resulting in pauses of use. Here we analyze the reports of adverse events associated with the COVID19 vaccines in the FDA Vaccine Adverse Event Reporting System (VAERS) database to apply standard methods of detecting safety signals. In this work we apply this methodology to reports in the FDA VAERS database and have identified concerning signals for pulmonary embolism and myocardial infarction associated with COVID19 vaccines. These signals are compared with cardiovascular events reported in connection with influenza (FLU3) vaccines that are administered to a similar population. While signals of these events are higher for COVID19 than other vaccines, the incidence rates are comparable to the normally expected rate for non-vaccinated individuals.


2021 ◽  
Vol 10 (8) ◽  
pp. 1660
Author(s):  
Annika Vestergaard Kvist ◽  
Junaid Faruque ◽  
Enriqueta Vallejo-Yagüe ◽  
Stefan Weiler ◽  
Elizabeth M. Winter ◽  
...  

Background: Cardiovascular safety concerns for major cardiovascular events (MACE) were raised during the clinical trials of romosozumab. We aimed to evaluate the cardiovascular safety profile of romosozumab in a large pharmacovigilance database. Methods: All cases reported between January 2019 and December 2020 where romosozumab was reported were extracted from the Food and Drug Administration Adverse Event Reporting System (FAERS). The outcome of interest was MACE (myocardial infarction (MI), stroke, or cardiovascular death). A disproportionality analysis was conducted by estimating the reporting odds ratios (RORs) and 95% confidence intervals. Disproportionality analyses were stratified by sex and reporting region (US, Japan, other). Results: Of the 1995 eligible cases with romosozumab, the majority (N = 1188; 59.5%) originated from Japan. Overall, 206 suspected MACE reports were identified, of which the majority (n = 164; 13.8%) were from Japan, and 41 (5.2%) were from the United States (US). Among Japanese reports, patients were older and more frequently male than reports from the US. Similarly, cases with a reported MACE were older and had higher reports of cardioprotective drugs than those without cardiovascular events. Elevated reports for MACE (ROR 4.07, 95% CI: 2.39–6.93) was identified overall, which was primarily driven by the significant disproportionality measures in the Japanese reports. Conclusions: The current pharmacovigilance study identified a potential signal for elevated MACE, particularly in Japan. The results support the current safety warnings from the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to avoid use in high-risk patients.


Vaccine ◽  
2019 ◽  
Vol 37 (44) ◽  
pp. 6760-6767 ◽  
Author(s):  
Michael M. McNeil ◽  
Iwona Paradowska-Stankiewicz ◽  
Elaine R. Miller ◽  
Paige L. Marquez ◽  
Srihari Seshadri ◽  
...  

2018 ◽  
Vol 268 ◽  
pp. 441-446 ◽  
Author(s):  
Yoon Kyong Lee ◽  
Jung Su Shin ◽  
Youngwon Kim ◽  
Jae Hyun Kim ◽  
Yun-Kyoung Song ◽  
...  

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