The Calls for Investigation into Vaccine Harms
The primary database for adverse events following any vaccine is the Vaccine Adverse Events Reporting System (VAERS), first established in 1990 and maintained jointly by both the CDC and FDA.[5] The intention of the database is to record all medical adverse events following a vaccine for further study as to whether the vaccine was the cause.
It is mandatory for medical providers to report the following:
• Any adverse event listed by the vaccine manufacturer as
a contraindication to further doses of the vaccine.
• Any adverse event listed in the VAERS Table of
Reportable Events Following Vaccination that occurs
within the specified time period after vaccination.*
• Legally required under the National Childhood Vaccine
Injury Act [156]
The FDA monitors all reports to VAERS, while the CDC focuses on vaccines used for public health initiatives, such as influenza. The Advisory Committee on Immunization Practices also determines priorities for the CDC to investigate. [157]
Doctors, epidemiologists and statisticians at the FDA and CDC assess the numbers of reports, the most common adverse events, whether they are serious and non-serious status,, and reporting trends over time such as comparisons of influenza vaccine reports across influenza seasons. [157]
An adverse event is classed as serious when it is life threatening or results in disability, brain damage, admission to hospital, birth defects, or medical intervention to prevent any of those outcomes.[6]
Serious reports are reviewed by the FDA, as are selected reports based on results of descriptive analysis and disproportionality analysis, and conditions otherwise selected as of interest. [157]
Numerical analysis of reports to look for disproportionality is done using several techniques based on the concept of the Proportional Reporting Ratio, which is a way of determining whether a particular adverse event is reported more commonly than other adverse events following a particular vaccine, or more commonly than following other vaccines. The basic formula is: [301, 302, 303]
The calculation of s is a chi squared value, and a measure of confidence.
It can be see that the proportionality comes down to a measure of how common a particular adverse event is compared to other adverse events from the vaccine, as compared to the same calculation for other vaccines.
More advanced statistical techniques include the Multi-Item Gamma Poisson Shrinker (MGPS), 2, 6, 7 which produces Empirical Bayesian Geometric Mean (EGBM) scores. The EBGM calculation is conceptually similar to that of the PRR but less likely to pick up a false positive.[158]
All such analysis has the same primary flaw in that if a vaccine causes multiple diagnoses then they will all become part of the denominator which will dilute the signal of each diagnosis individually. There is also no way of determining what size of signal indicates significance.
The FDA process for ascribing causality to a particular report of an adverse event involves assessing multiple factors:
(1) Chronologic data (e.g., plausible temporal sequence, dechallenge, rechallenge).
(2) Precedents (e.g., a causal relationship has been determined for other products with common structural features).
(3) Biological or pharmacological plausibility (e.g., toxic drug concentration in body fluid, occurrence of a recognized pharmacodynamic (PD) phenomenon).
(4) Information quality.
(5) Alternative etiologies (e.g., concurrent diseases or conditions, concomitant medications.
Coming to a conclusion about as to whether a vaccine is causal for an adverse event also involves looking at pre-clinical data, published literature, other safety databases such as the Vaccine Safety Datalink, clinical trials and studies from preapproval development programs, epidemiological studies, and product utilisation data. The FDA may do its own epidemiological studies or research into potential mechanisms that could underlie reactions such as the vaccine’s chemical structure and potential toxicities. [158]
The results of follow up to VAERS reports are not made available to the public. [307]
On March 11th 2026 the FDA announced a replacement system for VAERS called the Adverse Event Monitoring System (AEMS). [308] No changes to follow up procedures to reports have yet been announced
Underlying all such assessment of causality is the simple fact that many of the biological mechanisms behind chronic inflammatory illness and autoimmunity are unknown, so the process can be little more than educated guesswork.
Vaccine Safety Datalink
Further evaluation of data from the Vaccine Safety Datalink (VSD) is used to assess causality. The VSD was established in 1990 along with the VAERS database, and consists of eleven sites around the country which use a common model and dictionary for data, and supply information from electronic health records. Two further sites provide subject matter experts. [304]
Access to the data by independent researchers has historically been extremely limited so scrutiny of the conclusions of the government agencies has been essentially impossible. [306]
Clinical Immunization Safety Assessment
The Clinical Immunization Safety Assessment (CISA) Project is a network of vaccine safety experts from CDC, research centers and other partners, which provides free clinical consultations for healthcare providers with complex vaccine safety questions about individual patients. [305[]
Adverse Events Following Anthrax Vaccine
These are two search engines for VAERS reports:
It has been estimated that less than 1% of adverse events are reported [7,8,9]. In 2010 a team at Harvard Pilgrim Health Care designing an automated reporting system described the problems with VAERS and proposed a solution:
‘...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. Barriers to reporting include a lack of clinician awareness, uncertainty about when and what to report, as well as the burdens of reporting: reporting is not part of clinicians’ usual workflow, takes time, and is duplicative. Proactive, spontaneous, automated adverse event reporting imbedded within EHRs and other information systems has the potential to speed the identification of problems with new drugs and more careful quantification of the risks of older drugs.’[8]
However the team was never able to implement its improvements:
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.’[8]
To improve reporting, the DoD directed that:
‘Vaccines Events Reporting System (VAERS) reports shall be filed using Service reporting procedures for those events resulting in hospital admission, lost duty time or work of 24 hours or more, or from those events suspected to have resulted from contamination of a vaccine vial.’[10]
However there is no sign that the policy was ever actually implemented across military medicine. In 2002 the GAO observed:
'It appears that vaccine reactions are sometimes not reported to VAERS, however, for reasons that include reticence of military personnel to identify health problems and lack of familiarity with the reporting process.’[11]
In 2000 a report by Congress had put it more succinctly:
‘Preposterously low adverse report rates generated by DOD point to a program far more concerned with public relations than effective force protection or the practice of medicine.’[2]
In 2002 the Institute of Medicine (IOM) made the recommendation:
‘DoD should develop and implement a system to automate the generation of VAERS reports within the military health care system, using codes to identify from automated records those health care visits that are potentially vaccine related.’[12]
The calls for action made by medical bodies were myriad. The IOM stated in 2000:
‘The committee concludes that there is inadequate/insufficient evidence to determine whether an association does or does not exist between anthrax vaccination and long-term adverse health effects...’[13]
With the recommendation of:
‘Long-term longitudinal studies of participants in the Anthrax Vaccine Immunization Program that would actively monitor and systematically collect and analyze data about symptoms, functional status, and disease status.’
The Government Accountability Office stated in 1999:
Secretary of Defense should direct the Secretary of the Army, as Executive Agent for the anthrax vaccination program, to design and conduct a study on possible long-term side effects of the anthrax vaccine and develop a communications plan to provide servicemembers information on the status of this effort.[14]
And again in 2002:
'Secretary of Defense should direct the establishment of an active surveillance program (unlike the passive VAERS) to identify and monitor adverse events associated with each anthrax vaccine immunization. This program should ensure that appropriate and complete treatment and follow-up are provided to those who have experienced adverse events and to those who may experience them in the future.’[11]
The Congressional Committee on Government Reform recommended in 2000:
‘DOD should enroll all anthrax vaccine recipients in a comprehensive clinical evaluation and treatment program for long term study.’[2]
The fiscal year 2000 Defense Appropriations Act contained a provision directing the Comptroller General to report on:
'Effects on morale, retention and recruiting; the civilian costs and burdens associated with adverse reactions for members of the reserve components; adequacy of long and short term health monitoring; assessment of the anthrax threat, including but not limited to foreign doctrine, weaponization, quality of intelligence, and other biological threats. DOD was directed to contract with the National Research Council to conduct studies on: vaccine adverse events and adverse reactions, particularly among women; vaccine efficacy against inhalation anthrax; correlation of animal models to safety and efficacy in humans; research gaps; and other matters.[2]
The Consolidated Appropriations Act for Fiscal Year 2000 directed:
‘The National Institutes of Health, CDC, and DOD to conduct a collaborative study on the safety and efficacy of vaccines used against biological agents.’[15]
An independent civilian advisory panel was created called the Anthrax Vaccine Expert Committee (AVEC) to review VAERS reports, but no meaningful follow up study was done. As noted by the IOM in 2002:
‘...the IOM committee is generally skeptical about attribution of causality, such as those that AVEC makes, from reports to a surveillance system like VAERS, especially given the potential for misclassification of reported events when considering them as possibly related or unrelated to vaccination. The committee emphasizes that a review of case reports to VAERS is appropriate only for the generation of hypotheses.’[12]
In 2002 the IOM also made the recommendation:
‘DMSS can be used both to generate and test hypotheses. If VAERS raises a hypothesis, it can be further evaluated in DMSS. DMSS data can also be used to generate hypotheses (as in its quarterly screening reports); these then need to be evaluated in more detail within DMSS, including more detailed data analyses and efforts that might involve review of medical records, for example.’[12]
It went on to recommend that the data be made available publicly:
‘DoD personnel working with DMSS data are necessarily limited in time and focus. DMSS data could therefore yield valuable insights in the hands of civilian researchers.’[12]
And that the DoD should:
‘Collaborate with the Department of Veterans Affairs (VA) to monitor service members who receive medical care through VA facilities after separation from military service. Linking of data from DMSS to data from VA is a possible tool.’[12]
DMSS is a surveillance system which monitors the health of the military. As stated on the DoD web site:
'The Armed Forces Health Surveillance Division (AFHSD) operates the Defense Medical Surveillance System (DMSS), a continuously expanding relational database that documents military and medical experiences of service members throughout their careers. As the central repository of medical surveillance data for the U.S. Armed Forces, DMSS contains up-to-date and historical data on diseases and medical events (e.g., hospitalizations, ambulatory visits, reportable medical events, HIV tests, and casualty data) and longitudinal data on personnel and deployments.[16,17]
However, no meaningful research was ever done.
The Vaccine Healthcare Centers Network
In 2001 Congress directed:
‘...the DOD to establish a system for monitoring adverse reactions to the anthrax vaccine and to establish guidelines under which servicemembers could obtain access to a treatment facility for expedited treatment and follow up of adverse events.’[3]
And that:
‘...the establishment of the VHC Network would, among other things, facilitate data collection and training.’
The result was the creation of the Vaccine Healthcare Centers Network (VHC) in 2001. However the DoD did not create a mission statement, nor provide funding and incorporate the VHC into the MILVAX structure, until December 2006 (which, coincidentally or otherwise, was the month following the departure of Secretary Rumsfeld), as was detailed by Congress in 2008:
‘VHC Network budget requests were submitted to the Army annually beginning in fiscal year 2002; however, the VHC Network was never incorporated into the Army’s budget. Similarly, although requests were submitted for inclusion in DOD’s 5-year budgets, prepared in fiscal years 2004 and 2006, the VHC Network’s costs were not included in the 5-year budgets.’[3]
In 2006 the Army considered closing the branches of the VHC for the Navy and Air Force due to the lack of any funding being provided by either service[13].
The GAO published a report in 2007 which noted:
‘VHC Network officials stated that the unpredictability of the VHC Network’s budget from one year to the next had affected facility development and staff retention, and compromised the VHC Network’s ability to provide services and to accomplish its mission.’[13]
Even after the budget had been sorted out in December 2006 the Pentagon did not use the VHC as had been intended, and the National Defense Authorization Act for Fiscal Year 2007 specifically prohibited DOD from downsizing or restructuring the VHC Network.[13]
Despite the difficulties, the VHC did some investigative work which included liaising with the CDC and some universities The GAO investigation in 2007 noted:
Officials from the VHC Network and CDC estimate that between 1 and 2 percent of immunized individuals may experience severe adverse events, which could result in disability or death.'[13]
How that figure determined was not referenced, but the figure should have sent shock waves through the Pentagon.
Also, observations of patients did show some patterns:
‘For example, the VHC Network has created clinical definitions for six additional adverse events not previously characterized, such as new onset of headaches, muscle pain, chronic fatigue, and autoimmune disorders, in order to help providers identify such symptoms as possible adverse events .'[13]
However the VHC web site has now been erased from the internet along with much of the information that it contained.