Saturday, June 15, 2013

A Mother's Collection: 87 Studies on Vaccines & Adverse Health Concerns



87 Published Works on Vaccines and Adverse Health Concerns

Although safety is not my sole reason for declining vaccines, it is one. I want to take this opportunity to provide a resource - an offer of research thatexamines the safety and health risks associated when a vaccine is utilized in the determent of a specific disease.


Below is published research that proposes concern in the safety of vaccines to the health of the individual. I encourage you to click on the title to review the published work for yourself – however, I included a brief synopsis directly from the published work.

Also – I am including some valuable links that I have referenced over the years (and still do) at the bottom of this post.


(*Please note: Although the DTP vaccine is still administered in other parts of the world it is not currently included on the United State’s CDC schedule, because of this, I did NOT include any research regarding the safety of this vaccine – although the published research out there is abundant. One exception: the Allergy/Asthma section contain a few references of the DTP vaccine because the association was not due to the specific DTP injection but rather to the diphtheria and tetanus toxiod. )

(*Another important note: research cited does not establish causation by vaccine but rather it expresses that the concerns parents have over safety of vaccines are valid and justify further research to assess the long-term impact of vaccination)




Safety Concern: Neurologic & Immune Dysfunction/Development  



The Journal of Pediatrics 2007

CRP (cardio-respiratory complications) level is expected to be elevated in the 48 hours following immunization. In a minority of infants immunized, cardiorespiratory events were associated with presumed need for intervention. Underlying medical conditions and possibly multiple injections are associated with cardiorespiratory events. Precautionary monitoring following immunizations is warranted.




International Journal of Toxicology  2004 

The present study provides additional epidemiological evidence supporting previous epidemiological, clinical and experimental evidence that administration of thimerosal-containing vaccines in the United States resulted in a significant number of children developing NDs (neuro-developmental disorders)



(thimerosal is in the following vaccines Tripedia (DTaP),Afluria (Influenza), Fluvirin (Influenza), Flulaval (Influenza), Fluzone (Influenza),Decavac (Td), Mass Biologics (Td))



British Medical Journal (BMJ) 2010

Many serious adverse reactions to this year’s seasonal influenza vaccine have occurred across Australia, and its use remains suspended in children aged 5 years and under.1 2 3 Data released on 1 June 2010 show that 1 in every 110 young children vaccinated with the CSL vaccine had a febrile seizure.





Acta Neurobiologiae Experimentalis 2010 

This longitudinal, case-control pilot study examined amygdala growth in rhesus macaque infants receiving the complete US childhood vaccine schedule (1994-1999). …results suggest that maturational changes in amygdala volume and the binding capacity of [C]DPN in the amygdala was significantly altered in infant macaques receiving the vaccine schedule/ The macaque infant is a relevant animal model in which to investigate specific environmental exposures and structural/functional neuroimaging during neurodevelopment.




Journal of Biomedical Science 2002

The MMR antibody in autistic sera detected measles HA protein, which is unique to the measles subunit of the vaccine. Furthermore, over 90% of MMR antibody-positive autistic sera were also positive for MBP autoantibodies, suggesting a strong association between MMR and CNS autoimmunity in autism. Stemming from this evidence, we suggest that an inappropriate antibody response to MMR, specifically the measles component thereof, might be related to pathogenesis of autism.

Medical Hypotheses 2011  

Conjugate vaccines fundamentally change the manner in which the immune systems of infants and young children function by deviating their immune responses to the targeted carbohydrate antigens from a state of hypo-responsiveness to a robust B2 B cell mediated response. This period of hypo-responsiveness to carbohydrate antigens coincides with the intense myelination process in infants and young children, and conjugate vaccines may have disrupted evolutionary forces that favored early brain development over the need to protect infants and young children from capsular bacteria.





Neurochemical Research 2011

There is a need to interpret neurotoxic studies to help deal with uncertainties surrounding pregnant mothers, newborns and young children who must receive repeated doses of Thimerosal-containing vaccines (TCVs). Thimerosal at concentrations relevant for infants' exposure (in vaccines) is toxic to cultured human-brain cells and to laboratory animals. The persisting use of TCV (in developing countries) is counterintuitive to global efforts to lower Hg exposure and to ban Hg in medical products; its continued use in TCV requires evaluation of a sufficiently nontoxic level of ethylmercury compatible with repeated exposure (co-occurring with adjuvant-Al) during early life.




Safety Concern: Aluminum Adjuvants



Current Medicinal Chemistry 2011

Aluminum is an experimentally demonstrated neurotoxin and the most commonly used vaccine adjuvant. Despite almost 90 years of widespread use of aluminum adjuvants, medical science's understanding about their mechanisms of action is still remarkably poor. There is also a concerning scarcity of data on toxicology and pharmacokinetics of these compounds. In spite of this, the notion that aluminum in vaccines is safe appears to be widely accepted. Experimental research, however, clearly shows that aluminum adjuvants have a potential to induce serious immunological disorders in humans. In particular, aluminum in adjuvant form carries a risk for autoimmunity, long-term brain inflammation and associated neurological complications and may thus have profound and widespread adverse health consequences.





Lupus 2012  

Immune challenges during early development, including those vaccine-induced, can lead to permanent detrimental alterations of the brain and immune function. Experimental evidence also shows that simultaneous administration of as little as two to three immune adjuvants can overcome genetic resistance to autoimmunity. In summary, research evidence shows that increasing concerns about current vaccination practices may indeed be warranted. Because children may be most at risk of vaccine-induced complications, a rigorous evaluation of the vaccine-related adverse health impacts in the pediatric population is urgently needed





Journal of Inorganic Biochemistry 2009

The demonstrated neurotoxicity of aluminum hydroxide and its relative ubiquity as an adjuvant suggest that greater scrutiny by the scientific community is warranted.




Journal of Inorganic Biochemistry 2009
Macrophagic myofasciitis (MMF) is an emerging condition, characterized by specific muscle lesions assessing long-term persistence of aluminum hydroxide within macrophages at the site of previous immunization. Long-term persistence of vaccine-derived aluminum hydroxide within the body assessed by MMF is associated with cognitive dysfunction, not solely due to chronic pain, fatigue and depression.



Journal of Inorganic Biochemistry 2011

Macrophagic myofasciitis (MMF) is characterized by specific muscle lesions assessing long-term persistence of aluminum hydroxide within macrophages at the site of previous immunization. Affected patients are middle-aged adults, mainly presenting with diffuse arthromyalgias, chronic fatigue, and cognitive dysfunction.





Journal of Inorganic Biochemistry 2011

The application of the Hill's criteria to these data indicates that the correlation between Al in vaccines and ASD may be causal. Because children represent a fraction of the population most at risk for complications following exposure to Al, a more rigorous evaluation of Al adjuvant safety seems warranted.




Trends in Immunology 2010

Aluminium adjuvants potentiate the immune response, thereby ensuring the potency and efficacy of typically sparingly available antigen. Their concomitant critical importance in mass vaccination programmes may have prompted recent intense interest in understanding how they work and their safety. Progress in these areas is stymied, however, by a lack of accessible knowledge pertaining to the bioinorganic chemistry of aluminium adjuvants, and, consequently, the inappropriate application and interpretation of experimental models of their mode of action





Immunology and Allergy Clinics of North America 2003

The authors conclude that the persistence of aluminum hydroxide at the site of intramuscular injection is a novel finding which has an exact significance that remains to be established fully. It seems mandatory to evaluate possible long-term adverse effects induced by this compound, because this issue has not been addressed (in the past, aluminum hydroxide was believed to be cleared quickly from the body). If safety concerns about the long-term effects of aluminum hydroxide are confirmed, novel and alternative vaccine adjuvants to rescue vaccine-based strategies should be proposed to ensure the enormous benefit for public health that these vaccines provide worldwide.



Brain 2001

In the present study, intracytoplasmic inclusions were constantly detected in macrophages of the MMF lesion, and were shown to contain aluminium by three different methods. Hisotry revealed that all MMF patients has been immunized 3 months to 8 years before muscle biopsy by aluminiun-containing vaccines.




Medical Hypotheses 2008

Macrophagic myofasciitis and chronic fatigue syndrome are severely disabling conditions which may be caused by adverse reactions to aluminium-containing adjuvants in vaccines. While a little is known of disease aetiology both conditions are characterised by an aberrant immune response, have a number of prominent symptoms in common and are coincident in many individuals.




Lupus 2012

The inflammasome plays a central role in Al mode of action and in CD pathophysiology. It is suggested that Al adjuvant activity can fit between the aberrations of innate and adaptive immune responses occurring in CD. The CD mucosa is confronted with numerous inappropriate bacterial components adsorbed on the Al compound surface, constituting a pro-inflammatory supra-adjuvant. Al fits the diagnostic criteria of the newly described autoimmune/inflammatory syndrome induced by adjuvants. If a cause and effect relationship can be established, the consequences will greatly impact public health and CD prevention and management.




Safety Concern: Brain Inflammation Post Vaccination



Neurology 2007

Acute disseminated encephalomyelitis (ADEM) is an immune-mediated inflammatory disorder of the CNS characterized by a widespread demyelination that predominantly involves the white matter of the brain and spinal cord. The condition is usually precipitated by a viral infection or vaccination.





Journal of Toxicology and Environmental Health 2007

Eight of nine patients (one patient was found to have an ASD due to Rett's syndrome) (a) had regressive ASDs; (b) had elevated levels of androgens; (c) excreted significant amounts of mercury post chelation challenge; (d) had biochemical evidence of decreased function in their glutathione pathways; (e) had no known significant mercury exposure except from Thimerosal-containing vaccines/Rho(D)-immune globulin preparations; and (f) had alternate causes for their regressive ASDs ruled out.

Based upon differential diagnoses, 8 of 9 patients examined were exposed to significant mercury from Thimerosal-containing biologic/vaccine preparations during their fetal/infant developmental periods, and subsequently, between 12 and 24 mo of age, these previously normally developing children suffered mercury toxic encephalopathies that manifested with clinical symptoms consistent with regressive ASDs.

(The Rho(D)-immune globulin injection was mentioned throughout this paper – if you would like to learn more about administering the Rhogam shot during pregnancy please check out Critical Look at Rhogam and Rhesus Disease)




Postgraduate Medical Journal 2003

Acute disseminated encephalomyelitis (ADEM) is an acute demyelinating disorder of the central nervous system, and is characterised by multifocal white matter involvement. Diffuse neurological signs along with multifocal lesions in brain and spinal cord characterise the disease. Possibly, a T cell mediated autoimmune response to myelin basic protein, triggered by an infection or vaccination, underlies its pathogenesis. Recent literature suggests that a significant proportion of patients with ADEM will later develop multiple sclerosis; however, follow up experience from developing countries does not support this view.




Seminars In Neurobiology 2002

Smallpox is one of the deadliest infectious diseases in history. The discovery by Edward Jenner that inoculation with a droplet of pus from a cow with cowpox protected a person from smallpox resulted in the successful vaccination of millions of people. There were, however, complications associated with smallpox vaccination; the most serious complication was postvaccinal encephalitis, which was reported to occur with an incidence of 1 in 110,000 vaccinations and a case-fatality rate of 50%. Before we become complacent with the idea that we will respond to a bioterrorism attack with a mass immunization program for smallpox, it is important to be reminded of the risk and clinical manifestations of postvaccinal encephalitis and the efficacy of antivaccinia gamma-globulin in preventing this complication. The first case of postvaccinal encephalitis as a complication of the Jennerian cowpox inoculation was observed in 1905. A century later, there is no effective therapy.



Journal of Experimental Pathology 1926

In view of the close resemblance between the clinical manifestations, the uniformity of the histological changes and the absence of similar cases independent of vaccination there can be no doubt that vaccination was a definite causal factor.

The only virus demonstrated experimentally in the tissue of the brain and cord was a vaccinial virus. Experiement did not prove this virus to have neurotroptic properties of exceptional intensity.




Safety Concern: Autoimmune Disease



Journal of Autoimmunity 2011

The role of various environmental factors in the pathogenesis of immune mediated diseases is well established. Of which, factors entailing an immune adjuvant activity such as infectious agents, silicone, aluminium salts and others were associated with defined and non-defined immune mediated diseases both in animal models and in humans. In recent years, four conditions: siliconosis, the Gulf war syndrome (GWS), the macrophagic myofasciitis syndrome (MMF) and post-vaccination phenomena were linked with previous exposure to an adjuvant. Furthermore, these four diseases share a similar complex of signs and symptoms which further support a common denominator.Thus, we review herein the current data regarding the role of adjuvants in the pathogenesis of immune mediated diseases.



Lupus 2012 

During the past year a new syndrome was introduced and termed ASIA, ‘Autoimmune (Auto-inflammatory) Syndrome induced by Adjuvants. This syndrome assembles a spectrum of immune-mediated diseases triggered by an adjuvant stimulus.

Taken together, this global view of ASIA probably represents only the tip of the iceberg. Encouraging physicians and patients to report adjuvant-related conditions will enable a better estimation of the true prevalence as well as the width of ASIA spectrum.





The Rheumatologist 2011

Despite their ability to boost immune responses, in the past, adjuvants were generally considered to be inert materials that posed little or no independent threat to the host. Alas, animal studies as well as reports of human diseases have clearly demonstrated the ability of adjuvants to inflict diseases by themselves.10

Aluminum is a widely used adjuvant that may produce immune activation and induce autoimmunity.

From these observations, it appears that the activation of the immune system by natural adjuvants (e.g., infectious agents) or pharmaceutical ones (e.g., vaccines containing alum or silicone), while usually followed by a desired activation of the immune system, could, in certain situations, trigger manifestations of autoimmunity or even autoimmune diseases itself.






Infectious Disease Clinics of North America 2011

Chronic fatigue syndrome (CFS) is characterized by unexplained fatigue that lasts for at least 6 months with a constellation of other symptoms. Recently, the AISA (autoimmune/inflammatory syndrome induced by adjuvants) syndrome was recognized, indicating the possible contribution of adjuvants and vaccines to the development of autoimmunity.



Acta Reumatologica Portuguesa 2011

Recently, reports have suggested grouping different autoimmune conditions that are triggered by external stimuli as a single syndrome called autoimmune/inflammatory syndrome induced by adjuvants (ASIA). This syndrome is characterized by the appearance of myalgia, myositis, muscle weakness, arthralgia, arthritis, chronic fatigue, sleep disturbances, cognitive impairment and memory loss, and the possible emergence of a demyelinating autoimmune disease caused by systemic exposure after vaccines and adjuvants.





Lupus 2012

Shoenfeld et al. suggested that four conditions – siliconosis, macrophagic myofaciitis (MMF), GWS and post-vaccination phenomena – that share clinical and pathogenic resemblances, may be incorporated into common syndrome called ‘Autoimmune (Autoinflammatory) Syndrome induced by Adjuvants’ (ASIA). Symptoms and signs of the four conditions described by Shoenfeld et al. show that at least eight out of ten main symptoms are in correlation in all four conditions. Namely, myalgia, arthralgias, chronic fatigue, neurological cognitive impairment, gastrointestinal symptoms, respiratory symptoms, skin manifestations and appearance of autoantibodies. Regardless of the aetiology of GWS, be it exposure to environmental factors or chemical drugs, vaccinations or the adjuvants in them, GWS fits well with the definition of ASIA and is included as part of ‘Shoenfeld’s syndrome’.





Lupus 2012 

In this study we analyzed the clinical and demographic manifestations among patients diagnosed with immune/autoimmune-mediated diseases post-hepatitis B vaccination. We aimed to find common denominators for all patients, regardless of different diagnosed diseases, as well as the correlation to the criteria of Autoimmune (Auto-inflammatory) Syndrome induced by Adjuvants (ASIA).

The ASIAcriteria were found to be very useful among adults with post-vaccination events. The application of the ASIA criteria to pediatric populations requires further study.




Brain 2001

We conclude that the MMF lesion is secondary to a intramuscular injection of aluminum hydroxide-containing vaccines, shows both long-term persistence of aluminum hydroxide and an ongoing local immune reaction, and is detected in patients with systemic symptoms which appeared subsequently to vaccination.



Lupus 2012

Aluminium oxyhydroxide (alum), a nanocrystalline compound forming agglomerates, has been used in vaccines for its immunological adjuvant effect since 1927. Alum is the most commonly used adjuvant in human and veterinary vaccines, but the mechanisms by which it stimulates immune responses remain incompletely understood. Although generally well tolerated, alum may occasionally cause disabling health problems in presumably susceptible individuals. A small proportion of vaccinated people present with delayed onset of diffuse myalgia, chronic fatigue and cognitive dysfunction, and exhibit very long-term persistence of alum-loaded macrophages at the site of previous intramuscular (i.m.) immunization, forming a granulomatous lesion called macrophagic myofasciitis (MMF).

Animal experiments indicate that biopersistent nanomaterials taken up by monocyte-lineage cells in tissues, such as fluorescent alum surrogates, can first translocate to draining lymph nodes, and thereafter circulate in blood within phagocytes and reach the spleen, and, eventually, slowly accumulate in the brain.





Revue Neurologique 2003

Electron microscopy, microanalytical studies, experimental procedures, and an epidemiological study recently demonstrated that the lesion is due to persistence for years at site of injection of an aluminum adjuvant used in vaccines.

Therefore, the WHO recommended an epidemiological survey, currently conducted by the French agency AFSSAPS, aimed at substantiating the possible link between the focal macrophagic myofasciitis lesion (or previous immunization with aluminum-containing vaccines) and systemic symptoms. Interestingly, special emphasis has been put on Th-2 biased immune responses as a possible explanation of chronic fatigue and associated manifestations known as the Gulf war syndrome.

Moreover, the war vaccine against anthrax, which is administered in a 6-shot regimen and seems to be crucially involved, is adjuvanted by aluminum hydroxide and, possibly, squalene, another Th-2 adjuvant. If safety concerns about long-term effects of aluminum hydroxide are confirmed it will become mandatory to propose novel and alternative vaccine adjuvants to rescue vaccine-based strategies and the enormous benefit for public health they provide worldwide.



Neurology 2004

A potential link between the recombinant hepatitis B vaccine and an increased risk of multiple sclerosis (MS) has been evaluated in several studies, but some of them have substantial methodologic limitations.

These findings are consistent with the hypothesis that immunization with the recombinant hepatitis B vaccine is associated with an increased risk of MS, and challenge the idea that the relation between hepatitis B vaccination and risk of MS is well understood.



Multiple Sclerosis 2009

Vaccination is generally considered safe in patients with multiple sclerosis (MS). We report five patients who presented with multifocal or atypical demyelinating syndromes within 21 days of immunization with the quadrivalent human papilloma virus (HPV) vaccine, Gardasil. Although the target population for vaccination, young females, has an inherently high risk for MS, the temporal association with demyelinating events in these cases may be explained by the potent immuno-stimulatory properties of HPV virus-like particles which comprise the vaccine. A prospective case–control study of patients with MS or clinically isolated demyelinating syndromes receiving the Gardasil® vaccine may provide relevant safety data in this population.



Concern: Asthma and Allergy



Epidemiology 1997

The Christchurch Health and Development Study comprises 1,265 children born in 1977. The 23 children who received no diphtheria/pertussis/tetanus (DPT) and polio immunizations had no recorded asthma episodes or consultations for asthma or other allergic illness before age 10 years; in the immunized children, 23.1% had asthma episodes, 22.5% asthma consultations, and 30.0% consultations for other allergic illness. Similar differences were observed at ages 5 and 16 years. These findings do not appear to be due to differential use of health services (although this possibility cannot be excluded) or con-founding by ethnicity, socioeconomic status, parental atopy, or parental smoking.



Clinical Immunology 2001

Circulating immunoglobulin E (IgE) is one of the characteristics of human allergic diseases including allergic asthma. We recently showed that infection of human B cells with rhinovirus or measles virus could lead to the initial steps of IgE class switching. Since many viral vaccines are live viruses, we speculated that live virus vaccines may also induce IgE class switching in human B cells.

Our data suggest that a potential side effect of vaccination with live attenuated viruses may be an increase in the expression of IgE.



The Journal of Allergy and Clinical Immunology 2008

Early childhood immunizations have been viewed as promoters of asthma development by stimulating a TH2-type immune response or decreasing microbial pressure, which shifts the balance between TH1 and TH2 immunity.

Among 11,531 children who received at least 4 doses of DPT, the risk of asthma was reduced to ½ in children whose first dose of DPT was delayed by more than 2 months. The likelihood of asthma in children with delays in all 3 doses was 0.39 (95% CI, 0.18-0.86).

We found a negative association between delay in administration of the first dose of whole-cell DPT immunization in childhood and the development of asthma; the association was greater with delays in all of the first 3 doses. The mechanism for this phenomenon requires further research.



Journal of Manipulative Physiologic Therapeutics 2000

Findings from animal and human studies confirm that diphtheria and tetanus toxoids and pertussis (DTP) and tetanus vaccinations induce allergic responses; associations between childhood vaccinations and subsequent allergies have been reported recently.

The odds of having a history of asthma was twice as great among vaccinated subjects than among unvaccinated subjects. The odds of having had any allergy-related respiratory symptom in the past 12 months was 63% greater among vaccinated subjects than unvaccinated subjects. The associations between vaccination and subsequent allergies and symptoms were greatest among children aged 5 through 10 years.



The Journal of Allergy and Clinical Immunology 2004

In the last 3 decades, there has been an unexplained increase in the prevalence of asthma and hay fever.

The data included 515 never vaccinated, 423 partially vaccinated, and 239 completely vaccinated children. In multiple regression analyses there were significant (P < .0005) and dose-dependent negative relationships between vaccination refusal and self-reported asthma or hay fever only in children with no family history of the condition and, for asthma, in children with no exposure to antibiotics during infancy. Vaccination refusal was also significantly (P < .005) and negatively associated with self-reported eczema and current wheeze. A sensitivity analysis indicated that substantial biases would be required to overturn the observed associations.

Parents who refuse vaccinations reported less asthma and allergies in their unvaccinated children. Although this relationship was independent of measured confounders, it could be due to differences in other unmeasured lifestyle factors or systematic bias. Further research is needed to verify these results and investigate which exposures are driving the associations between vaccination refusal and allergic disease.






Safety Concern: General Autoimmunity Issues




Autoimmunity Reviews 2005

According to Hippocratic tradition, the safety level of a preventive medicine must be very high, as it is aimed at protecting people against diseases that they may not contract. This paper points out that information on the safety of hepatitis B vaccine (HBV) is biased as compared to classical requirements of evidence-based medicine (EBM), as exemplified by a documented selectivity in the presentation or even publication of available clinical or epidemiological data.

As compared to other drugs, especially if their benefit is prevention only, a striking point of HBV (Hep B Vaccine) hazards emerges from the following triptyque: (1) the frequency of its adverse effects; (2) their severity; (3) their variety.

In HBV documented hazards, two main categories emerge: (1) central demyelinating disorders (2)disorders reproducing the non-hepatic manifestation of natural hepatitis B, which leads to question the rationality of injection viral antigens added with adjuvants in order to protect against an infection where the causative agent is not always cytotoxic by itself.

The aim of this paper was to stimulate research on the unusual toxicity of HBV vaccine and to induce international pressure on health authorities in order to obtain the release of the whole of cumulated clinical and epidemiological evidence in the normal circulation of scientific information and peer-reviewed research.






Nature Reviews Rheumatology 2009

The latency period between vaccination and autoimmunity ranges from days to years. In this article, on the basis of published evidence and our own experience, we discuss the various aspects of the causal and temporal interactions between vaccines and autoimmune phenomena, as well as the possible mechanisms by which different components of vaccines might induce autoimmunity.



Journal of Autoimmunity 1996

The current review summarizes case reports attributing autoimmune diseases and phenomena to various vaccines and suggests potential mechanisms. The subject is complicated by the fact that one vaccine may cause more than one autoimmune phenomenon, and a particular immune process may be caused by more than one vaccine. The subject of the vaccine-autoimmunity relationship is still obscure.

Laborious clinical and laboratory studies should be initiated in order to evaluate the new emerging subject of vaccine-induced autoimmunity.





Lupus 2012

Immune challenges during early development, including those vaccine-induced, can lead to permanent detrimental alterations of the brain and immune function. Experimental evidence also shows that simultaneous administration of as little as two to three immune adjuvants can overcome genetic resistance to autoimmunity. In some developed countries, by the time children are 4 to 6 years old, they will have received a total of 126 antigenic compounds along with high amounts of aluminum (Al) adjuvants through routine vaccinations.

In summary, research evidence shows that increasing concerns about current vaccination practices may indeed be warranted. Because children may be most at risk of vaccine-induced complications, a rigorous evaluation of the vaccine-related adverse health impacts in the pediatric population is urgently needed.





PLOS ONE 2009 

Repeated immunization with antigen causes systemic autoimmunity in mice otherwise not prone to spontaneous autoimmune diseases. Systemic autoimmunity appears to be the inevitable consequence of over-stimulating the host's immune ‘system’ by repeated immunization with antigen, to the levels that surpass system's self-organized criticality.




Safety Concern: Chronic Illness



Clinical Infectious Diseases 1992

The committee spent 20 months reviewing a wide range of information sources including case series and individual case reports published in peer-reviewed journals and reported by vaccine manufacturers; unpublished case reports from physicians, parents, and other concerned persons; epidemiological studies; and laboratory studies. There were no animal studies available. The committee found that the evidence is consistent with a causal relation between the RA 27/3 rubella vaccine strain and chronic arthritis in adult women.




Lupus 2012

Giant cell arteritis (GCA) and polymyalgia rheumatica (PMR) are inflammatory rheumatic diseases common in people over the age of 50 years. Herein, we report 10 cases of previously healthy subjects who developed GCA/PMR within 3 months of influenza vaccination (Inf-V). A Medline search uncovered additional 11  isolated cases of GCA/PMR occurring after Inf-V. We discuss the role of individual susceptibility, the potential function of immune adjuvants as triggers of autoimmunity post-vaccination, and the correlation of our observation with the ‘ASIA’ syndrome,




Toxicological & Environmental Chemistry 2008

This study investigated the association between vaccination with the Hepatitis B triple series vaccine prior to 2000 and developmental disability in children aged 1–9 years (n = 1824), proxied by parental report that their child receives early intervention or special education services (EIS). The odds of receiving EIS were approximately nine times as great for vaccinated boys (n = 46) as for unvaccinated boys (n = 7), after adjustment for confounders. This study found statistically significant evidence to suggest that boys in United States who were vaccinated with the triple series Hepatitis B vaccine





PLOS ONE 2012

Narcolepsy is a rare neurological sleep disorder especially in children who are younger than 10 years. In the beginning of 2010, an exceptionally large number of Finnish children suffered from an abrupt onset of excessive daytime sleepiness (EDS) and cataplexy. Therefore, we carried out a systematic analysis of the incidence of narcolepsy in Finland between the years 2002–2010.

A sudden increase in the incidence of abrupt childhood narcolepsy was observed in Finland in 2010. We consider it likely that Pandemrix vaccination contributed, perhaps together with other environmental factors, to this increase in genetically susceptible children.



The Lancet 2010

We have some concerns about the long-term safety of this adjuvant-containing formulation. The manufacturer chose aluminum hydroxide, a long-used adjuvant known to potentate immune response through strong Th2 immunostimulatory effects.





Journal of Pediatric Endocrinology and Metabolism 2003

We previously analyzed data from a hemophilus vaccine trial and identified clusters of extra cases of type 1 diabetes mellitus (T1DM) caused by the vaccine that occurred between 36 and 48 months after immunization.

The identification of clusters of cases of T1DM occurring in consistent temporal time periods allowed a link between the hemophilus vaccine and T1DM to be established. The current findings indicate the there are also clusters of cases of T1DM occurring 2-4 years post-immunization with the pertussis, MMR, and BCG vaccine. The data are consistent with the occurrence of clusters following mumps infection and the progression to T1DM in patients with antipancreatic autoantibodies.



Autoimmunity 2002

The hemophilus vaccine has been linked to the development of autoimmune type 1 diabetes, insulin dependent diabetes (IDDM) in ecological studies. We attempted to determine if the Hemophilus influenza B (HiB) vaccine was associated with an increased risk of IDDM by looking for clusters of cases of IDDM using data from a large clinical trial. 
Exposure to HiB immunization is associated with an increased risk of IDDM.



Medical Hypotheses 2001

Immunization with a number of different vaccines, including live and killed vaccines, has been linked to the development of insulin-dependent (type 1) diabetes in humans and animals. Multiple different mechanisms have been proposed to explain the association between vaccines and diabetes. The current paper reviews multiple different mechanisms by which vaccines are known to manipulate the immune system and can induce an autoimmune disease such as type 1 diabetes.





Clinical Microbiology Reviews 2004

The polyomavirus simian virus 40 (SV40) is a known oncogenic DNA virus which induces primary brain and bone cancers, malignant mesothelioma, and lymphomas in laboratory animals. Persuasive evidence now indicates that SV40 is causing infections in humans today and represents an emerging pathogen.

The discovery of the polyomavirus SV40, as well as its introduction as a pathogen into the human population, was tied to the development and worldwide distribution of early forms of the polio vaccine. It is noteworthy that SV40 has been detected in malignancies from children and young adults not exposed to contaminated polio vaccines, as well as in older adults.

However, the epidemiological data available are recognized to be inconclusive and the Institute of Medicine found that the epidemiological data for cancer rates in people potentially exposed to SV40-contaminated vaccines are inadequate to evaluate a causal relationship. This conclusion is based on the lack of data on which individuals actually received contaminated vaccines, the unknown dosage of infectious SV40 present in particular lots of vaccine, the failure to know who among the exposed were successfully infected with SV40, the inability to know if the vaccine “unexposed” cohorts may have been exposed to SV40 from other sources, and the difficulty of monitoring a large population for cancer development for years after virus exposure.

The Institute of Medicine recently concluded that “the biological evidence is of moderate strength that SV40 exposure could lead to cancer in humans under natural conditions.” This review analyzes the accumulating data that indicate that SV40 is a pathogen which has a possible etiologic role in human malignancies.




Safety Concern: Disease Transmission



Science 2012

Recombination between herpesviruses has been seen in vitro and in vivo under experimental conditions. This has raised safety concerns about using attenuated herpesvirus vaccines in humans…and adds to other known concerns associated with their use, including reversion to virulence and disease arising from recurrent reactivation of lifelong chronic infection.





American
Academy of Pediatrics 2012 

Although rotavirus vaccines are known to be shed in stools, transmission of vaccine-derived virus to unvaccinated contacts resulting in symptomatic rotavirus gastroenteritis has not been reported to our knowledge.

We document here the occurrence of vaccine-derived rotavirus (RotaTeq) transmission from a vaccinated infant to an older, unvaccinated sibling, resulting in symptomatic rotavirus gastroenteritis that required emergency department care.

Results of our investigation suggest that reassortment between vaccine component strains of genotypes [] …raising the possibility that this reassortment may have increased the virulence of the vaccine-derived virus. 




Journal of Virology 2012


Long-term (several years) persistence of vaccine derivatives in immunocompromised persons and the ability of the evolved variants to cause paralytic disease are well-established phenomena. Recent outbreaks of poliomyelitis in Egypt , the Dominican Republic and Haiti, and the Philippines, caused by evolved derivatives of vaccine viruses of types 1 and 2, support the notion that there is a significant risk of prolonged circulation of the vaccine viruses in populations with a low immunity level, as well as their conversion into epidemic strains. Highly evolved Sabin vaccine derivatives have also been isolated from sewage even in the absence of apparent cases of paralytic poliomyelitis.




Journal of Clinical Microbiology 2000

An unusual, highly diverged derivative of the Sabin type 2 oral poliovaccine (OPV) strain was recovered from environmental samples during routine screening for wild polioviruses.

The presence in the environment of a highly evolved, neurovirulent OPV-derived poliovirus in the absence of polio cases has important implications for strategies for the cessation of immunization with OPV following global polio eradication.




Journal of General Virology 2002

A survey of poliovirus in river and sewage water was conducted from October 1993 to September 1995 in Toyama Prefecture, Japan. In this study, 25 isolates differentiated as type 2 vaccine-derived polioviruses (VDPVs) were characterized.

The prevalence of virulent-type VDPVs in river and sewage water suggested that the oral poliovaccine itself had led to wide environmental pollution in nature. To terminate the cycle of virus transmission in nature, the ecology of VDPVs should be studied further




Vaccine 2011

During a recent mumps epidemic in the Netherlands
caused by a genotype D mumps virus strain, we investigated the potential of vaccinated people to spread mumps disease to close contacts.

We also investigated the occurrence of mumps infection among the household contacts of vaccinated mumps patients. We found that viral titers are higher for unvaccinated patients than for vaccinated patients during the 1st 3 days after onset of disease.

We conclude that, in this particular outbreak, the risk of a close contact becoming infected by vaccinated patients was small, but present.


Safety Concern: Efficacy Issues/Failure


Pediatrics 2012

During the 2010 pertussis epidemic in California, there was considerable concern in the press and in public health communications about the possible contribution of vaccine failures to the problem.1,2 In this commentary, I examine why pertussis vaccines fail.

The first reason, and perhaps the most important one, is that our estimates of vaccine efficacy have been inflated because of case definition





Clinical Infectious Diseases 2012

Despite widespread childhood vaccination against Bordetella pertussis, disease remains prevalent. It has been suggested that acellular vaccine may be less effective than previously believed. During a large outbreak, we examined the incidence of pertussis and effectiveness of vaccination in a well-vaccinated, well-defined community.

Our data suggests that the current schedule of acellular pertussis vaccine doses is insufficient to prevent outbreaks of pertussis. We noted a markedly increased rate of disease from ages 8–12 years, proportionate to the interval since the last scheduled vaccine.





Proceedings Biological Science 2010

Despite over 50 years of population-wide vaccination, whooping cough incidence is on the rise. Although Bordetella pertussis is considered the main causative agent of whooping cough in humans, Bordetella parapertussis infections are not uncommon. The widely used acellular whooping cough vaccines (aP) are comprised solely of B. pertussis antigens that hold little or no efficacy against B. parapertussis. Here, we ask how aP vaccination affects competitive interactions between Bordetella species.

Thus, we conclude that aP vaccination interferes with the optimal clearance of B. parapertussis and enhances the performance of this pathogen. Our data raise the possibility that widespread aP vaccination can create hosts more susceptible to B. parapertussis infection.




Vaccine 2012

We investigated a mumps outbreak within a highly vaccinated university student population in the Netherlands by conducting a retrospective cohort study among members of university societies in DelftLeiden and Utrecht.

High coverage of MMR vaccination in childhood did not prevent an outbreak of mumps in this student population.





New England Journal of Medicine 2012

In the United States, children receive five doses of diphtheria, tetanus, and acellular pertussis (DTaP) vaccine before 7 years of age. The duration of protection after five doses of DTaP is unknown.

Conclusions: Protection against pertussis waned during the 5 years after the fifth dose of DTaP. (Funded by Kaiser Permanente).



Vaccine 2012

The basic assumptions inherent to the varicella cost–benefit analysis ignored the significance of exogenous boosting caused by those shedding wild-type VZV. Also ignored was the morbidity associated with even rare serious events following varicella vaccination as well as the morbidity from increasing cases of HZ among adults. Vaccine efficacy declined below 80% in 2001.

By 2006, because 20% of vaccinees were experiencing breakthrough varicella and vaccine-induced protection was waning, the CDC recommended a booster dose for children and, in 2007, a shingles vaccination was approved for adults aged 60 years and older. In the prelicensure era, 95% of adults experienced natural chickenpox (usually as children)—these cases were usually benign and resulted in long-term immunity.

Varicella vaccination is less effective than the natural immunity that existed in prevaccine communities. Universal varicella vaccination has not proven to be cost-effective as increased HZ morbidity has disproportionately offset cost savings associated with reductions in varicella disease. Universal varicella vaccination has failed to provide long-term protection from VZV disease.




Medicine 2010

Since the introduction of the mumps vaccine, the age of appearance of mumps infection has shifted from children to adolescents and young adults, groups with a higher incidence of disease complications. Serious complications have appeared as a consequence because of the higher rate of sequelae among the older age-group.

Although the mumps virus is one of the most frequent viral causes of accurate lymphocytic meningitis (and this is the primary justification for routine childhood immunization), there are conflicting opinions regarding the frequency of central nervous system involvement in mumps.



National Academic Press 2002

Important and often overlooked, mass vaccinations itself can also exert tremendous selective pressures and lead to the evolution of new infectious agents.


The Lancet 2003

An increase in invasive Hib disease incidence in the UK
has coincided with the distribution of combination vaccines that contain acellular pertussis (DTaP-Hib). These vaccines have been associated with reduced immunogenicity of the Hib component



Safety Concern: Questionable Placebos / Policy


Annals of Internal Medicine 2010
No regulations govern placebo composition. The composition of placebos can influence trial outcomes and merits reporting.




Vaccine 2009

The FDA encourages the use of placebos and provides a conceptual basis for the practice. The FDA however does not specifically address placebos in children or other vulnerable subjects.

For intramuscular and subcutaneous vaccinations, injections of sterile normal saline may serve as placebos, but researchers frequently choose other comparative agents. A review of the most recently published trials involving vaccines for children found a variety of comparators that took the place of placebos in children. For example, a recent study of pneumococcal conjugate vaccine with nine serotypes (PCV-9) used as its comparator an active vaccine. Specifically, the PCV-9 was reconstituted with the DTP-Hib vaccine. The comparator was vaccine-diluent mixed with the same DTP-Hib vaccine. In another study, a novel, bivalent, heat-killed, whole-cell oral cholera vaccine is compared to a similarly manufactured, heat-killedEscherichia coli K12 vaccine-a vaccine of no therapeutic benefit. In a third, recent study of a pneumococcal conjugate vaccine with seven stereotypes paired serially with a 23-valent, pneumococcal polysaccharide vaccine, the investigators used as the comparator hepatitis A or B vaccines. In a fourth study, the study vaccine consisted of a Pseudomonas aeruginosa flagellar protein combined with aluminum hydroxide and thimerosal. The comparator consisted of just aluminum hydroxide combined with thimerosal.



Clinical Infectious Diseases 2011

Parental immunization has been recommended as a “cocoon” strategy to prevent serious pertussis outcomes in early infancy. The NNV for parental immunization was at least 1 million to prevent 1 infant death. In the context of low pertussis incidence, the parental cocoon program is inefficient and resource intensive for the prevention of serious outcomes in early infancy.



Safety Concern: Unexplained Infant Death



Human Exp Toxicology 2011

The infant mortality rate (IMR) is one of the most important indicators of the socio-economic well-being and public health conditions of a country. The US childhood immunization schedule specifies 26 vaccine doses for infants aged less than 1 year—the most in the world—yet 33 nations have lower IMRs. Using linear regression, the immunization schedules of these 34 nations were examined and a correlation coefficient of r = 0.70 (p < 0.0001) was found between IMRs and the number of vaccine doses routinely given to infants.

Using the Tukey-Kramer test, statistically significant differences in mean IMRs were found between nations giving 12–14 vaccine doses and those giving 21–23, and 24–26 doses. A closer inspection of correlations between vaccine doses, biochemical or synergistic toxicity, and IMRs is essential.




Journal of Pediatrics 2007

To determine the incidence of cardiorespiratory events and abnormal C-reactive protein (CRP) level associated with administration of a single vaccine or multiple separate vaccines simultaneously.
Abnormal elevation of CRP level occurred in 85% of infants administered multiple vaccines and up to 70% of those given a single vaccine.

CRP level is expected to be elevated in the 48 hours following immunization. In a minority of infants immunized, cardiorespiratory events were associated with presumed need for intervention. Underlying medical conditions and possibly multiple injections are associated with cardiorespiratory events. Precautionary monitoring following immunizations is warranted.



Virchows Archives 2006

Experts from panels of the European Agency for the Evaluation of Medical Products have investigated whether there might be a link between hexavalent vaccines and some cases of deaths that occurred. Participants included pathologists with experience in the field of vaccines and sudden infant death syndrome who conducted autopsies. However, to the best of our knowledge, little, if any, attention was paid to examination of the brainstem and the cardiac conduction systems on serial sections, nor was the possibility of a triggering role of the vaccine in these deaths considered. Herein we report the case of a 3-month-old female infant dying suddenly and unexpectedly shortly after being given a hexavalent vaccination. Examination of the brainstem on serial sections revealed bilateral hypoplasia of the arcuate nucleus. The cardiac conduction system presented persistent fetal dispersion and resorptive degeneration. This case offers a unique insight into the possible role of hexavalent vaccine in triggering a lethal outcome in a vulnerable baby. Any case of sudden unexpected death occurring perinatally and in infancy, especially soon after a vaccination, should always undergo a full necropsy study according to our guidelines.




Journal of Forensic Legal Medicine 2007

The simultaneous sudden deaths of twins rarely occur and therefore it has received limited attention in the medical literature. When the deaths of the twins meet the defined criteria for sudden infant death syndrome (SIDS) independently and take place within the same 24 h range it can be called as simultaneous SIDS (SSIDS). The case(s): Twin girls (3.5-month-old) were found dead by their mother in their crib, both in supine position.

Both infants were healthy and did not have any serious medical history. Two days prior to the incident, the twins had received the second dose of oral polio, DPT and the first dose of hepatitis B vaccines and they had fever on the first day of the vaccination and been given teaspoonful of acetaminophen. The Board decided that the available data was consistent with SIDS. These SIDS case(s) are presented because twin SIDS are rare.



More Resources

Vaccine Excipient & Media Summary (Ingredient Listing of Vaccines in the US


Search Clinical Trials

Package Inserts

More Research


This post reflects the research and concern that I have about vaccination.  It doesn’t represent my opinion of people who choose to vaccinate or not.  Please know that, while my family has made this decision, we respect the right of all parents to choose to vaccinate if they feel this is best for their child.  I don’t have all the answers.  Most of us don’t.  We’re all in the same boat in that we need to make the best decision we can with the information we have.  

No comments: