Adverse Event Under-Reporting

In the US fewer than 1% of vaccine adverse events are reported. It is reasonable to extrapolate approximate under-reporting rates in Ireland from these studies.

The stated purpose of the Lazarus Final Report was “to improve healthcare decision making through the use of integrated tools and knowledge management“.  Its scope was “[t]o create a generalizable system to facilitate detection and clinician reporting of vaccine adverse events, in order to improve the safety of national vaccination programs.”  The report unequivocally concluded that “fewer than 1% of vaccine adverse events are reported.”  It also pointed out that “[l]ow reporting rates preclude or slow the identification of “problem” drugs and vaccines that endanger public health”.

In December 2020, Robert F. Kennedy jr., wrote to Dr. David Kessler, one of the newly named co-chairs of President-Elect Biden’s Transition COVID-19 Advisory Board, asking him to consider the long-overdue need for a comprehensive, high-integrity system to monitor adverse outcomes following vaccination.  In the letter Kennedy unambiguously stated that the Vaccine Adverse Event Reporting is broken and that “[r]egulatory officials cannot count on post-marketing surveillance to reveal COVID-19 vaccine injuries because VAERS is broken”

In this study, designed to evaluate the reporting sensitivities of both The Monitoring System for Adverse Events Following Immunisation and The Vaccine Adverse Event Reporting System, the authors stated in their concluding discussion that:

Reporting of adverse events appears to depend on a number of factors, such as clinical seriousness, temporal proximity to vaccination and health care workers’ awareness of and obligation to report particular adverse events.22 In our study, reporting sensitivities for adverse events surveillance in the United States varied widely, ranging from 72% for vaccine-associated poliomyclitis to less than 1% for acute thrombocytopenic purpura folling MMR vaccine and hypotonic-hyporesponsive episodes following the DTP vaccine. This underreporting of known outcomes highlights the limitations of passive surveillance in measuring the incidence of vaccine adverse events.