Methods
Vaccine Adverse Event Reporting System (VAERS) is a national warning system established in 1990 to detect the possible safety problems of the US- Licensed vaccines. It is co-managed by the CDC and FDA. VAERS is a passive reporting system where Healthcare professionals, Vaccine manufacturers, and vaccine receivers anonymously report the adverse events that come under their attention. It is a freely and easily accessible platform that collects data from all over the globe and is updated regularly. The primary objectives of VAERS are to detect new, unusual, and rare adverse events of newly licensed vaccines, administration errors, increased monitoring of the known adverse events. The data is limited to vaccine adverse event reports between 1990 to the most recent date for which the data is available. The current study is compendious and exclusive to assess the incidence of Heart failure associated with all the US-licensed vaccines (COVID, Zoster, Influenza, HPV, Tetanus, Meningococcal, Hepatitis-A, Hepatitis-B, MMR)
We obtained information using the standardized medical terms according to the Medical Dictionary of Health Terms like “Cardiac dysfunction, Cardiomyopathy, Ventricular dysfunction, Diastolic dysfunction, Heart failure, Congestive heart failure, Systolic dysfunction, Systolic heart failure, Diastolic heart failure.”
The adverse events associated with the vaccines were assessed by disproportionality signal analysis was conducted by measuring Reporting Odds Ratio (ROR). ROR represents the odds of a certain event (Heart failure) occurring with the exposure to vaccine compared to the odds of the same event occurring with all other vaccines in the database. ROR was considered significant with the lower limit of the 95% Confidence Interval (CI) was >1.