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.