The Department of Health and Human Services (HHS) awarded Harvard Medical School a $1 million grant to track VAERS reporting at Harvard Pilgrim Healthcare for three years and develop an automated reporting system that would revolutionize the VAERS reporting system and transform it from a “passive” to an “active” system. The project was called “Electronic Support for Public Heath- Vaccine Adverse Reporting System (ESP:VAERS)” and was initiated “To create a generalizable system to facilitate detection and clinician reporting of vaccine adverse events, in order to improve the safety of national vaccination programs.”
To achieve this, the team used the electronic medical records of Harvard Pilgrim Healthcare, Inc, described as a “large multi-specialty practice.”
Data was collected with this new generalizable system from June 2006 to October 2009 on a total of 715,000 patients. 376,452 of those 715,000 patients, were given 1.4 million doses of 45 different vaccines. A total of 35,570 possible adverse reactions were identified. Out of only 376,452 individuals that received a vaccine at this Harvard practice, the new automated system identified 35,570 possible adverse reactions in a three year period. In contrast there are only ca 30,000 adverse events reported yearly for the entire US population of 330 Million in the VAERS system!
“Adverse events from drugs and vaccines are common, but underreported. Although 25% of ambulatory patients experience an adverse drug event, less than 0.3% of all adverse drug events and 1-13% of serious events are reported to the Food and Drug Administration (FDA). Likewise, fewer than 1% of vaccine adverse events are reported. Low reporting rates preclude or slow the identification of “problem” drugs and vaccines that endanger public health. New surveillance methods for drug and vaccine adverse effects are needed.”
After paying a $1 million grant and conducting three years of research on a seemingly highly successful upgrade to the VAERS passive system the result was that the CDC did NOT react to this study but stopped all communication and cooperation with the research team.
“Unfortunately, there was never an opportunity to perform system performance assessments because the necessary CDC contacts were no longer available and the CDC consultants responsible for receiving data were no longer responsive to our multiple requests to proceed with testing and evaluation.”
“However, real data transmissions of non-physician approved reports to the CDC was unable to commence, as by the end of this project, the CDC had yet to respond to multiple requests to partner for this activity.”
All that was left to do for the CDC was to link the VAERS system to the Harvard Pilgrim system to transmit the data. But that never happened. Why?
Electronic Support for Public Health – Vaccine Adverse Event Reporting System (ESP:VAERS) ESP:VAERS
Department of Ambulatory Care and Prevention, Harvard Medical School and Harvard Pilgrim Health Care, Boston, MA, USA.
Harvard Vaccine Injury Study