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Chronic fatigue syndrome and fibromyalgia following immunization with the hepatitis B vaccine

Bob

Senior Member
Messages
16,455
Location
England (south coast)
Chronic fatigue syndrome and fibromyalgia following immunization with the hepatitis B vaccine: another angle of the 'autoimmune (auto-inflammatory) syndrome induced by adjuvants' (ASIA).
Agmon-Levin N, Zafrir Y, Kivity S, Balofsky A, Amital H, Shoenfeld Y.
Immunol Res. 2014 Nov 27. [Epub ahead of print]
DOI 10.1007/s12026-014-8604-2
http://www.ncbi.nlm.nih.gov/pubmed/25427994/
http://link.springer.com/article/10.1007/s12026-014-8604-2

Abstract
The objectives of this study were to gather information regarding demographic and clinical characteristics of patients diagnosed with either fibromyalgia (FM) or chronic fatigue (CFS) following hepatitis B vaccination (HBVv) and furthermore to apply the recently suggested criteria of autoimmune (auto-inflammatory) syndromes induced by adjuvants (ASIA), in the aim of identifying common characteristics that may suggest an association between fibromyalgia, chronic fatigue and HBV vaccination. Medical records of 19 patients with CFS and/or fibromyalgia following HBVv immunization were analyzed. All of which were immunized during 1990-2008 in different centers in the USA. All medical records were evaluated for demographics, medical history, the number of vaccine doses, as well as immediate and long term post-immunization adverse events and clinical manifestations. In addition, available blood tests, imaging results, treatments and outcomes were analyzed. ASIA criteria were applied to all patients. The mean age of patients was 28.6 ± 11 years, of which 68.4 % were females. 21.05 % had either personal or familial background of autoimmune disease. The mean latency period from the last dose of HBVv to onset of symptoms was 38.6 ± 79.4 days, ranging from days to a year. Eight (42.1 %) patients continued with the immunization program despite experiencing adverse events. Manifestations that were commonly reported included neurological manifestations (84.2 %), musculoskeletal (78.9 %), psychiatric (63.1 %), fatigue (63.1 %), gastrointestinal complains (58 %) and mucocutaneous manifestations (36.8 %). Autoantibodies were detected in 71 % of patients tested. All patients fulfilled the ASIA criteria. This study suggests that in some cases CFS and FM can be temporally related to immunization, as part of ASIA syndrome. The appearance of adverse event during immunization, the presence of autoimmune susceptibility and higher titers of autoantibodies all can be suggested as risk factors. ASIA criteria were fulfilled in all patients eluding the plausible link between ASIA and CFS/FM.
 

Bob

Senior Member
Messages
16,455
Location
England (south coast)
Interesting for myself, because I was a health worker when I became ill with ME, and I had been receiving a series of Hep B booster vaccinations in the year before I became ill. I think my last booster vaccination was a few months prior to becoming ill. (There was no immediate reaction to the vaccinations.)
 
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Jonathan Edwards

"Gibberish"
Messages
5,256
Chronic fatigue syndrome and fibromyalgia following immunization with the hepatitis B vaccine: another angle of the 'autoimmune (auto-inflammatory) syndrome induced by adjuvants' (ASIA).
Agmon-Levin N, Zafrir Y, Kivity S, Balofsky A, Amital H, Shoenfeld Y.
Immunol Res. 2014 Nov 27. [Epub ahead of print]
DOI 10.1007/s12026-014-8604-2
http://www.ncbi.nlm.nih.gov/pubmed/25427994/
http://link.springer.com/article/10.1007/s12026-014-8604-2

Hmmm... Sounds like they took 19 people with ASIA syndrome and found they had ASIA syndrome. You cannot really argue with that!
 

A.B.

Senior Member
Messages
3,780
Interesting for myself, because I was a health worker when I became ill with ME, and I had been receiving a series of Hep B booster vaccinations in the year before I became ill. I think my last booster vaccination was a few months prior to becoming ill.

I had the HBV vaccine in the same year I suddenly developed extreme morning fatigue. About a year later the health problems started which eventually ended in a CFS diagnosis. I did not have any obvious reactions to the vaccine, but it is still suspicious because the association to CFS has been reported by multiple sources.
 

Marco

Grrrrrrr!
Messages
2,386
Location
Near Cognac, France
Hmmm... Sounds like they took 19 people with ASIA syndrome and found they had ASIA syndrome. You cannot really argue with that!

I'm not sure how to take that comment Jonathan. Either dismissing the significance or something more profound?

Assuming that the science behind ASIA syndrome is sound then there are two possibilities. The symptoms were due to ASIA syndrome and they were misdiagnosed with CFS/fibro or that they were correctly diagnosed (sic) and ASIA syndrome may be one of the 'ME's that leads to CFS or fibro.

Either way (while accepting that it's a single small study) may have theoretical and practical implications.
 

jimells

Senior Member
Messages
2,009
Location
northern Maine
onset of symptoms was 38.6 ± 79.4 days

I know nothing of statistics, but I know what the "plus or minus" symbol means. What is the point of a measurement with such a wide range? And what should I make of the fact that 38 minus 80 is a negative number of days? Does this mean that some patients have symptoms before the injections?
 
Messages
15,786
I know nothing of statistics, but I know what the "plus or minus" symbol means. What is the point of a measurement with such a wide range? And what should I make of the fact that 38 minus 80 is a negative number of days? Does this mean that some patients have symptoms before the injections?
It means that the range of days until onset of symptoms was really huge, to the point where giving a mean and/or standard deviation is probably pointless. But all would have been greater than 0. A graph would be more useful.
 

Snow Leopard

Hibernating
Messages
5,902
Location
South Australia
Hmmm... Sounds like they took 19 people with ASIA syndrome and found they had ASIA syndrome. You cannot really argue with that!

It seems they took patients who had CFS/FM, triggered by a Hep B immunisation and found they also met the ASIA criteria.

I'd love to see a large prospective study including CFS/ME and FM in the investigations after specific immunisations, but no one has done that study. CFS/ME are rarely if ever properly investigated or included in in generalised vaccination safety programmes.
 
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A.B.

Senior Member
Messages
3,780
Is Hep B vac the only one suspected of triggering CFS/ME? What about immune function test vaccines, for instance? Or tetanus?...

No, but it is disproportionally often reported to be related to CFS compared to other vaccines.

Anecdotal evidence indicates that a number of vaccinations, including flu vaccine, are capable of either triggering ME/CFS, or causing an exacerbation of pre-existing symptoms

But there hasn't been any really robust research carried out to investigate the role of this other type of immune system stressor in ME/CFS

I have a research interest in the role of vaccinations and my patient data on the subject, which is now quite substantial and includes a lot of health workers who are vaccinated almost as a condition of employment, indicates that hepatitis B vaccine plays an unusual and significant role here

This is supported by the resultrs of the MEA website poll on the roll of vaccinations as trigger factors for ME/CFS:

MEA WEBSITE POLL:



  • If your ME/CFS was triggered by a vaccination, which vaccine was involved?
    • Hepatitis B (57%, 338 Votes)

    • Flu (9%, 51 Votes)

    • Other (7%, 41 Votes)

    • BCG (6%, 33 Votes)

    • Cannot remember (5%, 31 Votes)

    • Combination (5%, 27 Votes)

    • Tetanus (3%, 18 Votes)

    • Meningitis (3%, 17 Votes)

    • MMR (2%, 14 Votes)

    • Polio (2%, 10 Votes)

    • Hepatitis A (1%, 7 Votes)

    • Typhoid (0%, 4 Votes)


      Total Voters: 591
Start Date: April 30, 2010 @ 3:20 pm
End Date: June 2, 2010 @ 3:20 pm
 

Jonathan Edwards

"Gibberish"
Messages
5,256
It seems they took patients who had CFS/FM, triggered by a Hep B immunisation and found they also met the ASIA critetria.

Yes, but that seems to BE the ASIA criteria - features of CFS after a vaccination. Which is why they ALL fulfilled the criteria! Doh!

As far as I can see ASIA is a syndrome (set of features) to which somebody has added a speculative theory about its cause. So ASIA cannot cause anything - it is a syndrome that is postulated to have a certain cause. This sort of conflation of cause and effect goes on all the time when doctors open their mouths. The speculative theory has existed long before the name ASIA and I doubt that the syndrome name is justified. A syndrome name is legitimate if features cluster more than expected by chance. Until someone has shown that I cannot see the justification. The present study is no use because they chose people with the cluster. I had never heard of ASIA. It sounds to me like the re-invention of a very old very square wheel.

Now you know what I meant Marco!
 

Bob

Senior Member
Messages
16,455
Location
England (south coast)
The mean latency period from the last dose of HBVv to onset of symptoms was 38.6 ± 79.4 days, ranging from days to a year.
I know nothing of statistics, but I know what the "plus or minus" symbol means. What is the point of a measurement with such a wide range? And what should I make of the fact that 38 minus 80 is a negative number of days? Does this mean that some patients have symptoms before the injections?
Well spotted! As Val says, this particular use of stats isn't appropriate. In theory, what it should tell us (but probably doesn't in this case) is that roughly 68% of the patients became ill between zero and 118 (38.6 + 79.4) days. (38.6 is the mean average, and the plus/minus figure refers to the 'standard deviation'.) But the end of their sentence (i.e. "ranging from days to a year") suggests that no one became ill immediately or on the first day.
 
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snowathlete

Senior Member
Messages
5,374
Location
UK
The problem with the poll above is that the more common vaccines are always going to end up at the top. I had HEP vaccine not long before coming down with ME/CFS and got very ill afterward for a while. It may or may not be related. Wish we knew, wish it was looked into properly. Unfortunately, studies like these, although exploring an interesting and worthwhile topic, obviously don't actually tell us much, as Prof Edwards pointed out already.
 

Ecoclimber

Senior Member
Messages
1,011
I read a news article a few years back on cluster group who came down with chronic fatigue syndrome after a Hepatitis vaccine in California but cannot locate the article. Here is some more information:

Hepatitis B Vaccine Side Effects
The majority of people who get the Hepatitis B vaccine have no reaction. However, approximately 35% do have some type of reaction — usually very mild. Experts estimate that 3% of people will have pain, redness, or tenderness at the injection site. Approximately 1-6% will develop a low-grade fever. Fewer than 0.001% will develop a serious allergic reaction.

Though the risk is small, life-threatening allergic reaction does occasionally occur after a Hepatitis B vaccination. This includes anaphylaxis or anaphylactic shock, which causes a whole-body allergic response. In some cases, this causes the muscles in the airway to become swollen and close off, which cuts off the person’s oxygen supply. This can cause permanent physical disability, intellectual disability, or death.

It is possible that there are other Hepatitis B vaccine side effects. These are likely so rare that it is difficult to tell whether they are caused by the vaccine.

Since 1989, the Vaccine Injury Compensation Program (VICP) has awarded more than $2.4 billion to help the victims of vaccine injuries. You have three years to file a claim after vaccination.

The VICP has reviewed 627 Hepatitis B vaccine lawsuits — 577 for injury, and 50 for death. As of June 1, 2012, they have awarded compensation in 210 cases and dismissed 353 cases.

In 2013, The United States Court of Federal Claims, plaintiff who came down with chronic fatigue syndrome and fibromyalgia after a hepatitis B vaccination was awarded $1.1 million damages and

Vaccine court

The preponderance of evidence standard under the Vaccine Act requires proof that a vaccine more likely than not caused the vaccinee’s injury. Althen, 418 F.3d at 1279. Causation is determined on a case-by-case basis, with “no hard and fast per se scientific or medical rules.” Knudsen, 35 F.3d at 548. On March 13, 2010, the court ruled in three test cases that thiomersal-containing vaccines do not cause autism. The test cases were among the strongest for this theory. Special Master Hastings concluded, "The overall weight of the evidence is overwhelmingly contrary to the petitioners' causation theories."
 

Hip

Senior Member
Messages
17,824
It's interesting that the researcher Schoenfeld who introduced the concept of autoimmune (auto-inflammatory) syndrome induced by adjuvants (ASIA) focused on vaccine adjuvants as the causal factor in vaccine-triggered illness.

Given that diseases such as ME/CFS can follow microbial infection, it would be conceivable that a vaccine-triggered illness might be caused by the attenuated pathogens within some vaccines. But these researchers seem to think that it is the adjuvants, not the attenuated viruses, that cause vaccine-triggered illness.

This paper says that the adjuvants which can precipitate ASIA are mainly: aluminum hydroxide, squalene and silicone.

Adjuvants are of course immune stimulants that boost the adaptive immune response, in order to ensure that the immune system fully responds to the pathogen antigens within the vaccine. Without adjuvants, vaccines may not "take."

Leaking silicone breast implants have also been linked to precipitating ME/CFS, so it would seem that any source of silicone within the body, not just from a vaccine, can trigger ME/CFS.


Presumably these substances have to be placed within the body or bloodstream before they can trigger a disease like ME/CFS. Aluminum hydroxide is an antacid, and there is no known connection between taking antacids and ME/CFS; and squalene is found in olive oil, and is used a a skin cream, and these don't cause ME/CFS.
 

A.B.

Senior Member
Messages
3,780
Adjuvants are of course immune stimulants that boost the adaptive immune response, in order to ensure that the immune system fully responds to the pathogen antigens within the vaccine. Without adjuvants, vaccines may not "take."

How do you know that the immune system only reacts to the pathogen antigens in the vaccine? Maybe it reacts to all other ingredients as well. Some vaccines are manufactured with yeast. If the vaccine still containd traces of yeast, is the person also getting vaccinated against yeast? This might lead inflammation of the intestine since yeast is part of the microbiome. Other vaccines are manufactured using human cell lines, or egg proteins. What about the nutrients the culture needs: can vaccines cause immune reactions against certain nutrients?

Anyway, I have wondered what's different about the Hepatitis B vaccine (it might be a particular product, ingredient or method of production that causes problems).
 

Jonathan Edwards

"Gibberish"
Messages
5,256
Presumably these substances have to be placed within the body or bloodstream before they can trigger a disease like ME/CFS. Aluminum hydroxide is an antacid, and there is no known connection between taking antacids and ME/CFS; and squalene is found in olive oil, and is used a a skin cream, and these don't cause ME/CFS.

I think there may be reasons relating to immunological fashion why adjuvant is hypothesised. The placing of the substances is actually very critical and rather interesting. Most vaccines are intramuscular. A few are intradermal, like typhoid. Both of these sites produce brisk 'danger' responses. The adjuvant tickles up macrophages and dendritic cells that pick up the antigen and take it to lymph node for adaptive immune response generation. But is you put the vaccine half way in between, in subcutaneous tissue the likelihood is that nothing will happen at all. This may be partly a spreading out effect because injection into muscle and dermis produces a pocket that stays where it is - in dermis you get a bleb like a nettle sting. If you inject into subcutaneous tissue the fluid tracks into spaces that go along tissue planes.
 

Hip

Senior Member
Messages
17,824
The placing of the substances is actually very critical and rather interesting. Most vaccines are intramuscular. A few are intradermal, like typhoid. Both of these sites produce brisk 'danger' responses.

The adjuvant tickles up macrophages and dendritic cells that pick up the antigen and take it to lymph node for adaptive immune response generation. But is you put the vaccine half way in between, in subcutaneous tissue the likelihood is that nothing will happen at all.

That's very interesting.

One 2008 paper said that the aluminum hydroxide adjuvant may boosts immunity by inducing uric acid, and thereby activating inflammatory dendritic cells. If that were the case, I wonder if you could simply replace the aluminum hydroxide adjuvant in the vaccine with uric acid itself.