Vaccine Adverse Events (VAE) or Adverse Event Following Immunization (AEFI) is defined by the World Health Organization as any untoward medical occurrence which is supected to be assiciated wuth immunization. A VAE may be any unfavourable or unintended sign, abnormal laboratory finding, symptom or disease. Since Covid-19 is an experimental biological product under emergency use authorization where an adverse event is defined as any untoward or unfavourable medical occurrence in a human study participant temporally associated with the participants’ involvment in the research wether or not considered related to the participant in the research.
Many countries maintain reporting systems for VAE that are part of Drug Adverse Events Reporting Systems. These reporting systems are passive reporting systems, meaning they rely on healthcare workers and others to send in reports on suspected adverse events of vaccines.
These reporting systems are especially useful for detecting unusual or unexpected patterns of adverse event reporting that might indicate a possible safety problem or also called “signals” related to a drug or a vaccine .
Established in 1990, the US-CDC VAER Vaccine Adverse Event Reporting System (VAERS) is a national early warning system to detect possible safety problems in U.S.-licensed vaccines. The US-CDC VAERS database is available for download as an excel file which includes a comprehensive anonymized dataset that can be searched according to dataset variables. Access VAERS Data through VAERS WONDER System here.
VAERS is co-managed by the Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA). VAERS accepts and analyzes reports of adverse events (possible side effects) after a person has received a vaccination. Anyone can report an adverse event to VAERS. Healthcare professionals are required to report certain adverse events and vaccine manufacturers are required to report all adverse events that come to their attention.
Numerous studies have revealed that these reporting systems have failed to capture a adequate picture of VAE due to substantial underreporting. This is especially worrying in relation to Covid-19 Vaccines that are showing a unacceptable increase in adverse events and that may represent only between 1 to 10% of the actual incidence. Read more here. The most disturbing are the very significant numbers of adverse events relate to the cerebro- and cardio- vascular systems as being reported from all the VAERS reporting systems.
Since the Covid-19 Vaccines were introduced the most comprehensive analysis of this database is maintained at OPEN VAERS. Open Vaers includes a “REd Box” Summary Section where adverse reactions are grouped to type of events and data of Covid-19 Vaccine Adverse Events are presented with historical and temporal (time) comparisons.