Adverse events: unreported or denied

As children’s physical, mental and emotional health continues to deteriorate, the commonly occurring symptoms of these deficits – e.g. allergies and asthma, learning disabilities, hyperactivity and aggression – tend to become viewed as normal. And when health authorities increasingly suppress evidence of vaccine harm, it’s no wonder some parents don’t consider it possible that these previously rare conditions could be caused in whole or in part by vaccinations. It’s also likely that when adverse health events arise, many health practitioners and parents are unable to recognize some which could possibly be due to vaccines. This is especially true when adverse events occur months or years after vaccinations. The Public Health Agency of Canada (PHAC) accepts only a very limited range of vaccine adverse events and even then, only if they occur within a very short time after injection and have been vetted by “experts” whose decisions may be subject to conflicts of interest. However, adverse event reports which have survived this stringent vetting process reveal anything but normalcy.

The 2006 Canadian National Report on Immunization1 states: “The vast majority of reports in the CAEFI [Canadian Adverse Event Following Immunization] system are submitted on a voluntary basis…a primary purpose of the voluntary reporting system is to detect signals of concern, for which capture of all events is not essential…it is dangerous to rely on the absolute number of reports alone when considering vaccine safety surveillance data.” The 2006 report adds, “there are many stages at which delays in reporting can occur…for example, delays caused by investigation into an accurate medical diagnosis or a search for etiologies other than the vaccine that may have caused the AEFI.” AEFIs are also reported by the other branch of Canada’s monitoring system, IMPACT [Immunization Monitoring Program ACTive], administered by the Canadian Paediatric Society. These reports are limited to cases at several ‘sentinel’ children’s hospitals. They may be further limited due to the conflicting dual purpose of IMPACT to track hospital admissions for both AEFIs and diseases which are candidates for new vaccine programs or possible future ones.

As of May, 2011, Health Canada’s MedEffectTM Canada Adverse Event Reporting section2 states: “Health Canada wants to know about all suspected adverse reactions, but especially if they are: unexpected (not consistent with product information or labeling)…serious…related to a health product that has been on the market less than 5 years.” The PHAC’s Vaccine Safety section3 informs us that, “In 1994, a multidisciplinary group called the Advisory Committee on Causality Assessment (ACCA) was established to review all case reports meeting criteria for severity or ‘unexpectedness’… Selection criteria for case review include, for example, all cases of meningitis/encephalitis, encephalopathy, febrile seizures, deaths and other events of a serious nature that have led to hospitalization. Each case is reviewed using the WHO-UMC (World Health Organization-Uppsala Monitoring Centre) causality assessment criteria of Very Likely, Probable, Possible, Unlikely, Unrelated, or Unclassifiable to determine whether the adverse event was related to the administration of the vaccine(s).4… All reports received from both active and passive surveillance systems are aggregated and stored in a computerized, web-enabled Adverse Event Following Immunization (AEFI) database at the Agency.”

On its reporting form, (current revised form here) the Public Health Agency of Canada (PHAC) lists “Encephalopathy/Encephalitis” as a reportable AEFI and asks for reporting of the following possibly-related symptoms:

  • depressed/altered level of consciousness, lethargy or personality change lasting 24 hours or more
  • focal or multifocal neurologic signs (ie occurring in one or more specific areas of the body rather than generalized)
  • fever of 38.0 degrees centigrade or more
  • CSF (cerebrospinal fluid) abnormality
  • EEG (electroencephalogram) abnormality
  • EMG (electromyography) abnormality
  • neuroimaging abnormality
  • brain/spinal cord histopathologic abnormality

In 2004, IMPACT published a study which claimed to show “no attributable case” of encephalopathy from more than 6.5 million doses of pertussis vaccines injected into Canadian children between 1993 and 2002.5 However, we provide evidence from two AEFI reports retrieved through the Access to Information Act that this may not be a reliable assessment. One of these reports links AEFIs to several different types of vaccines, including pertussis vaccines from ten vaccine lots; the other report deals solely with pertussis vaccines. The first report consists of fifteen pages and relates AEFIs to DPTP, DaPT and DTP vaccines injected in 1993, 1994, 1996 and 1997. As an example of why the IMPACT study is dubious, we provide below an analysis of the data in pages 2, 4 and 8 for symptoms which could have signaled encephalopathy.

Hypotonic-hyporesponsive episode:

  • 2 mos old girl
  • 2 mos old boy
  • 4 mos old boy
  • 6 mos old girl
  • 18 mos old boy
  • 1 yr old boy

Meningitis and/or encephalitis:

  • 4 yr old boy

Convulsions/seizure:

  • 6 mos old girl

Screaming episode/persistent crying:

  • 1 mos old girl
  • Three 2 mos old boys
  • 2 mos old girl
  • 4 mos old girl
  • 5 mos old boy
  • 1 yr old boy

Fever greater than or equal to 40.5 degrees centigrade:

  • 1 mos old girl
  • 2 mos old boy
  • 4 yr old girl
  • 5 yr old girl

Fever of 39.0-40.4 degrees centigrade:

  • 3 mos old girl
  • 3 mos old boy
  • 5 mos old boy
  • 6 mos old girl
  • (There are also several cases of fever without a recorded temperature.)

Severe pain and/or swelling:

  • 1 mos old girl
  • 2 mos old boy
  • 4 yr old girl
  • 5 yr old girl

Other less frequent symptoms possibly related to encephalopathy were: somnolence, hallucination, opisthtonos (severe muscle spasm with back arching), nervousness, and insomnia.

The above data are recorded as symptoms in 22 cases of AEFIs reported on the three pages analyzed. In the other twelve pages, similar symptoms plus one death are recorded in 53 cases of adverse events following injections of pertussis vaccines. The second AEFI report relates to two lots of DPT-P vaccine injected 1994-95. It lists 112 cases of symptoms, which could have signaled encephalopathy. In total, the two reports provide possible evidence of 187 cases of encephalopathy.

While this data does not definitively show encephalopathy according to the parameters set by the WHO (although “encephalopathy” is listed as a symptom in one case), it does provide evidence which conforms to the widely accepted overarching definition of encephalopathy as an altered mental state. Similar evidence has been acknowledged in monographs of pertussis-containing vaccines in the past. And while, for many cases, only one or two possible symptoms of this inclusive encephalopathy are listed in the reports, that doesn’t necessarily mean that no other such symptoms occurred. Also recall that vaccine adverse event reporting is voluntary, so a majority of such events are never reported. The 187 possible cases of encephalopathy recorded in the two reports occurred during the seven years, 1993-2000. Considering this, we question the 2004 IMPACT conclusion of “no attributable case” of encephalopathy from more than 6.5 million doses of pertussis vaccines injected during the nine year period, 1993-2002.

The Penta Project by Heather Fraser – The Canadian government allowed and documented the injuries and deaths of Canadian children following vaccination with an unlicensed vaccine in the 1990’s and then did nothing about it. If I’d bought a pack of gum I’d have had better consumer protection.

References

  1. http://www.phac-aspc.gc.ca/publicat/ccdr-rmtc/06vol132/32s3/5vacc-eng.php
  2. http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/ar-ei-info-eng.php#what
  3. http://www.phac-aspc.gc.ca/im/vs-sv/caefiss-eng.php
  4. http://who-umc.org/Graphics/24734.pdf
  5. Moore DL, Le Saux N, Scheifele D, Halperin SA; Lack of evidence of encephalopathy related to pertussis vaccine: active surveillance by IMPACT, Canada, 1993-2002.; Pediatric Infectious Disease Journal; 2004 June; 23(6):568-71; PMID: 15194842