"Introduction
... For over a year, scientists across the globe have faced complex challenges to combat the disease. Research for COVID-19 treatment included repurposing existing drugs along with the discovery of new drugs and vaccines. Currently, about thirteen COVID-19 vaccines are granted emergency approval in various countries... Due to an urgent need to prevent the further spread of COVID-19 infections, the conventional procedures for approval of new drug/vaccines could not be followed, and these vaccines were given emergency approval before completion of all three phases of clinical trials. This generates a solid reason for accumulating sound scientific evidence for these vaccines by monitoring the adverse events in the population post-vaccination.
Since during the study period, three vaccines, Comirnaty (BNT162b2), Moderna COVID‑19 Vaccine (mRNA-1273), COVID-19 Vaccine AstraZeneca (AZD1222), were widely used for vaccination; therefore, analysis from the adverse events reported in VigiBase was performed on these vaccines...
[W]e analyzed all the cardiovascular adverse events reported with COVID-19 vaccination in the WHO global pharmacovigilance database VigiBase and assessed any relationship between the adverse events with the vaccine. This study is also intended to generate a safety signal for COVID-19 vaccines at an early stage...
Results
There were 103,954 adverse events reported for 30,523 patients from 15th December 2020 to 24th January 2021. Most of the adverse events (AEs) were reported for three vaccines: BNT162b2 Pfizer, 1222 AstraZeneca, and Moderna COVID-19 vaccines since during the study period, these vaccines were used more commonly... A total of 4863 cardiovascular adverse events were reported from the 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%)...
According to the disproportionality analysis based on IC025 values, acute myocardial infarction, cardiac arrest, and circulatory collapse were associated with the vaccine used in the age group > 75 years. Hypertension and severe hypertension like hypertensive emergency and urgency were associated with vaccine use in almost all age groups and genders. Vaccines were also associated with rhythm disorders such as supraventricular tachycardia, sinus tachycardia, paroxysmal tachycardia, palpitations, etc. Peripheral circular failure was also found to be associated with vaccine use. Amongst the investigations and lab tests, abnormal ECG findings, raised C-reactive protein, increase in D-dimer, increase in troponin was found to be associated with the vaccine used in specific age group or gender or all subjects..
Discussion
... The current analysis shows the total number of cardiovascular adverse events was higher in individuals receiving Pfizer-BioNTech COVID-19 (BNT162b2) vaccine, although the values might not reflect the real situation as it was the first vaccine to get emergency approval from USFDA; hence a large number of doses have been administered till the period of analysis, and other reason could be a shorter interval between the two doses."
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