The official 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.

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]

These are two search engines for reports:

http://www.medalerts.org/

https://www.openvaers.com/

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.