Statement on Vaccine Adverse Event Reporting & Data Collection

National Vaccine Information Center
Institute of Medicine Vaccine Safety Forum
November 6, 1995

In 1982, when Kathi Williams and Jeff Schwartz and I got together with a small group of parents in the Washington, D.C. area and talked about setting up a national organization that would be dedicated to the prevention of vaccine injuries and deaths through public education, one of the first goals we listed was to obtain an improved vaccine adverse event reporting system. All of us had children who had been injured by the DPT vaccine. We knew that if our pediatricians and we, ourselves, had been better educated about vaccine high risk factors and side effects, there was a good chance our children would not have been injured. We believed then, and continue to believe today, that vaccine adverse event reporting and record keeping is the key to increased knowledge, better education and prevention of vaccine associated deaths and injuries.

So when we helped to create and pass the National Childhood Vaccine Injury Act of 1986, one of the five vaccine safety provisions that we insisted be at the heart of that law was the centralization of the government's adverse event reporting system. Up until that point, private physicians were reporting to the FDA and public health clinic physicians were reporting to the CDC. Our hope was that a centralized system, which in fact became the VAERS system as we know it today, would allow better detection and response to vaccine adverse event reports.

In order to achieve better detection and response, we also asked for a vaccine safety provision in the law that would legally require doctors to report hospitalizations, deaths and injuries following vaccination. Up until that time, there was a requirement for public health doctors but no formal requirement for private doctors to do that.

And we supported the provision that doctors give parents information about vaccine benefits and risks prior to vaccination and that doctors keep a permanent record of vaccinations given, including the manufacturers name and lot number. Up until that time, there were no requirements for doctors to do that and we thought that the recordkeeping requirement would be especially helpful in tracing and quickly removing from the market especially reactive lots of vaccines.

It was our hope that these vaccine safety provisions would mean that all doctors, not just 10 percent of them, would report adverse events following vaccination and that the VAERS system would follow up on each report and we would have a greater understanding of the nature and scope of adverse events associated with vaccination.

Most of our hopes and dreams for increased reporting, better education and prevention of vaccine deaths and injuries have not been realized through that law. And, again, as I said this morning, I believe that is because adverse event reporting and data collection will continue to remain flawed no matter what mechanism is put in place if there continues to be the presumption, especially by vaccine providers and government officials, that the case reports of deaths and injuries following vaccination are only temporally, not causally related to vaccination. No, I am not suggesting that there be a presumption that every adverse event case report is causally related to vaccination, although if your goal really is detection of vaccine adverse events then it is probably better to prove the vaccine did not play a role rather than to conveniently assume the vaccine did not play a role.

I believe this is a valid approach because the act of vaccination is a medical intervention that is carried out on healthy children who are required by law to participate. The requirements for adverse event reporting and data collection should be the most stringent and carefully met of all the biological products that are licensed for public use. A well funded, well run, well staffed vaccine adverse event reporting and data collection system should be at the very top of the national disease control strategy plan. And at every step along the way - from pre-licensing to post marketing surveillance - there should be the scientifically responsible presumption, at least, that a new or old vaccine has the potential to cause health problems that have not yet been detected because of the limits of human intelligence and scientific technology.

These, then, are the steps The National Vaccine Information Center supports to improve vaccine adverse event reporting and data collection:

1. Promote the introduction into medical school curriculums a course on vaccines, risks, benefits, side effects, adverse event reporting and education of parents so physicians can be better partners with parents in preventing vaccine associated deaths and injuries with the goal of raising physician reporting rates from 10 percent to 100 percent.
2. Commit HHHS funds to a public education campaign to educate physicians and the public about the importance of screening children for high risk factors, monitoring children after vaccination and reporting adverse events following vaccination to the government. In 1991 I presented a report to the National Vaccine Advisory Committee detailing 61 cases of death and injury following vaccination. Only 8 physicians out of the 61 cases ever made a report to VAERS, most of them telling parents that vaccines don't cause death or injury because it was all just a coincidence so there is no need to report. Set up an 800 telephone number for parents to report if physicians refuse to report. The National Vaccine Information Center helps parents every week report reactions that their physicians will not report.
3. Make vaccine adverse event reporting a legal requirement for doctors with penalties attached for failing to report. Like mandatory vaccination laws which keep children out of school for failing to be vaccinated, doctors should be prevented from administering vaccines if they refuse to report hospitalizations, deaths and injuries following vaccination.
4. Commit HHHS funds to the more efficient operation of VAERS, including increased staffing so that the VAERS operation is a model for every country in the world to follow. India, which delivers vaccines 25 million children every year, has an adverse event reporting system that includes an on-site investigation and follow-up by a public health team within 48 hours of every death and injury reported following vaccination. If a poor country like India can do it, this country should be able to do it.
5. The National Vaccine Information supports the concept of large linked databases for data collection on adverse events only if these linked databases are not used as a club to force vaccinations on individuals, who choose not to be vaccinated, or to exclude these individuals from health insurance coverage or to invade the privacy of individuals by making health information, including vaccination status, a matter of public record. We do not believe that analysis of large linked databases can or should replace the valuable information that can be learned from an efficiently operating VAERS system dedicated solely to the collection and analysis of reports of vaccine adverse events.

In summary, we believe that improved adverse event reporting and data collection will only occur when it is made an official public health policy priority and government health agencies do more to educate the public and vaccine providers about the importance of reporting and collecting data on adverse events following vaccination.