The fine print in the 2011-2012 flu vaccine inserts

When I walked into Kroger recently, I was immediately accosted by an employee trying to get me to take a flu shot.  I shouted, “Everyone, step up and get your formaldehyde and mercury, and if you’ll read the manufacturer inserts, you’ll see that the shots don’t work anyway.”  I asked the employee if she has read the inserts.  Of course, she had not.  I asked the employee if shots would one day be required before one can buy groceries.  She said “it might be coming to that.”  I said, “over my dead body.”

Two days later, I went into Walgreen’s, and I was accosted at the entrance.  She was right in my face, pushing the flu shots.  I said “get me the manufacturer’s inserts.”  She said all she has is this little pamphlet.  I asked if she’d read the real inserts – of course not.  Did she know about the additives, such as formaldehyde?  Of course not.  I said “if I were you I would educate myself.”  Then I took down a few of the flu shot signs.  When I left the store, no one was at the entrance accosting people about shots.  I think I freaked her out pretty good.

My response is this posting.

The vaccination locations may provide you with a dumbed-down excerpt of the vaccine package insert. Here, I’ve gathered all the 2011-2012 flu vaccine manufacturer inserts and posted the pdf files at the bottom of this post.  I’ve also included the material safety data sheets for some common additives (such as Triton X-100, a severe carcinogen).

You don’t have to be a microbiologist to understand these facts.  Basically, the inserts don’t claim that vaccination protects you from flu, the vaccines aren’t tested for their effects on pregnancy or fertility, and no effort has been expended to see if they cause cancer or mutation.

Given that they don’t test for pregnancy effects, it is curious why that population is so thoroughly propagandized toward yearly vaccination.  It reminds me a little of the tetanus / human chorionic gonadotropin (hCG) issue, but that’s another story.

Quotes from the fine print of the inserts follow:

Fluzone:

“Pregnancy Category C: Animal reproduction studies have not been conducted with Fluzone or Fluzone High-Dose. It is also not known whether Fluzone or Fluzone High-Dose can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Fluzone or Fluzone High-Dose should be given to a pregnant woman only if clearly needed.”

“It is not known whether Fluzone or Fluzone Intradermal is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Fluzone or Fluzone Intradermal is administered to a nursing woman.”

“Formaldehyde” (editor’s note – a preservative known to be carcinogenic)

“Octylphenol Ethoxylate” (editor’s note – Dow’s marketing name is Triton X-100; severe cancer-causing according to the material safety data sheet)

“Gelatin” (editor’s note – made from the collagen in cow or pig bones, hooves, and connective tissues;  if you’re Jewish, Muslim, or vegetarian, you probably don’t want this injected into your body)

“25 mcg mercury” (editor’s note – a known bio-accumulating neurotoxin)

“Specific levels of hemagglutination inhibition (HI) antibody titer post-vaccination with inactivated influenza virus vaccines have not been correlated with protection from influenza virus infection. In some human studies, antibody titers ≥1:40 have been associated with protection from influenza illness in up to 50% of subjects.”

“Fluzone, Fluzone High-Dose, and Fluzone Intradermal have not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility.”

“The following events have been spontaneously reported during the post-approval use of Fluzone or Fluzone High-Dose. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure. Adverse events were included based on one or more of the following factors: severity, frequency of reporting, or strengh of evidence for a causal relationship to Fluzone or Fluzone High-Dose. Events Reported During Post-Approval Use of Fluzone. • Blood and Lymphatic System Disorders: Thrombocytopenia, lymphadenopathy • Immune System Disorders: Anaphylaxis, other allergic/hypersensitivity reactions (including urticaria, angioedema) • Nervous System Disorders: Guillain-Barré syndrome (GBS), convulsions, febrile convulsions, myelitis (including encephalomyelitis and transverse myelitis), facial palsy (Bell’s palsy), optic neuritis/neuropathy, brachial neuritis, syncope (shortly after vaccination), dizziness, paresthesia • Vascular Disorders: Vasculitis, vasodilatation/flushing • Respiratory, Thoracic and Mediastinal Disorders: Dyspnea, pharyngitis, rhinitis • Skin and Subcutaneous Tissue Disorders: Stevens-Johnson syndrome • General Disorders and Administration Site Conditions: Pruritus, asthenia/fatigue, pain in extremities, chest pain.  Events Reported During Post-Approval Use of Fluzone High-Dose. • Gastrointestinal Disorders: Nausea, vomiting, diarrhea”

Flumist:

“Animal reproduction studies have not been conducted with FluMist. It is not known whether FluMist can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. FluMist should be given to a pregnant woman only if clearly needed.”

“It is not known whether FluMist is excreted in human milk. Therefore, as some viruses are excreted in human milk, caution should be exercised if FluMist is administered to nursing mothers.”

“Immune mechanisms conferring protection against influenza following receipt of FluMist vaccine are not fully understood.”

“FluMist has not been evaluated for its carcinogenic or mutagenic potential or its potential to impair fertility.”

“Inactive Ingredients: monosodium glutamate, gelatin, arginine, sucrose, dibasic potassium phosphate, monobasic potassium phosphate, and gentamicin.”

“The following adverse reactions have been identified during postapproval use of FluMist. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure. Cardiac disorders: Pericarditis Congenital, familial, and genetic disorders: Exacerbation of symptoms of mitochondrial encephalo- myopathy (Leigh syndrome) Gastrointestinal disorders: Nausea, vomiting, diarrhea Immune system disorders: Hypersensitivity reactions (including anaphylactic reaction, facial edema, and urticaria)  Nervous system disorders: Guillain-Barré syndrome, Bell’s Palsy, meningitis, eosinophilic meningitis, vaccine-associated encephalitis Respiratory, thoracic, and mediastinal disorders: Epistaxis Skin and subcutaneous tissue disorders: Rash”

Fluvarin:

“Pregnancy Category C: Animal reproduction studies have not been conducted with FLUVIRIN®. It is also not known whether FLUVIRIN® can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. FLUVIRIN® should be given to a pregnant woman only if clearly needed.”

“It is not known whether FLUVIRIN® is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when FLUVIRIN® is administered to a nursing woman.”

“Specific levels of hemagglutination inhibition (HI) antibody titers post-vaccination with inactivated influenza virus vaccine have not been correlated with protection from influenza illness. In some human studies, antibody titer of ≥1:40 have been associated with protection from influenza illness in up to 50% of subjects.”

“FLUVIRIN® has not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility.”

“The following additional adverse reactions have been reported during post- approval use of FLUVIRIN®. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure. Adverse events described here are included because: a) they represent reactions which are known to occur following immunizations generally or influenza immunizations specifically; b) they are potentially serious; or c) the frequency of reporting. Body as a whole: Local injection site reactions (including pain, pain limiting limb movement, redness, swelling, warmth, ecchymosis, induration), hot flashes/flushes; chills; fever; malaise; shivering; fatigue; asthenia; facial edema. Immune system disorders: Hypersensitivity reactions (including throat and/or mouth edema). In rare cases, hypersensitivity reactions have lead to anaphylactic shock and death. Cardiovascular disorders: Vasculitis (in rare cases with transient renal involvement), syncope shortly after vaccination. Digestive disorders: Diarrhea; nausea; vomiting; abdominal pain. Blood and lymphatic disorders: Local lymphadenopathy; transient thrombocytopenia. Metabolic and nutritional disorders: Loss of appetite. Musculoskeletal: Arthralgia; myalgia; myasthenia. Nervous system disorders: Headache; dizziness; neuralgia; paraesthesia; confusion; febrile convulsions; Guillain-Barré Syndrome; myelitis (including encephalomyelitis and transverse myelitis); neuropathy (including neuritis); paralysis (including Bell’s Palsy). Respiratory disorders: Dyspnea; chest pain; cough; pharyngitis; rhinitis. Skin and appendages: Stevens-Johnson syndrome; sweating; pruritus; urticaria; rash (including non-specific, maculopapular, and vesiculobulbous). Anaphylaxis has been reported after administration of FLUVIRIN®. Although FLUVIRIN® contains only a limited quantity of egg protein, this protein can induce immediate hypersensitivity reactions among persons who have severe egg allergy. Allergic reactions include hives, angioedema, allergic asthma, and systemic anaphylaxis. Neurological disorders temporally associated with influenza vaccination such as encephalopathy, optic neuritis/neuropathy, partial facial paralysis, and brachial plexus neuropathy have been reported. Microscopic polyangiitis (vasculitis) has been reported temporally associated with influenza vaccination.”

Fluarix:

“There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, FLUARIX should be given to a pregnant woman only if clearly needed.”

“It is not known whether FLUARIX is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when FLUARIX is administered to a nursing woman.”

“Specific levels of hemagglutination-inhibition (HI) antibody titer post-vaccination with inactivated influenza virus vaccines have not been correlated with protection from influenza illness but the HI antibody titers have been used as a measure of vaccine activity. In some human challenge studies, HI antibody titers of ≥1:40 have been associated with protection from influenza illness in up to 50% of subjects.”

“FLUARIX has not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility.”

“Each 0.5-mL dose also contains octoxynol-10 (TRITON® X-100) ≤0.085 mg, α-tocopheryl hydrogen succinate ≤0.1 mg, and polysorbate 80 (Tween 80) ≤0.415 mg. Each dose may also contain residual amounts of hydrocortisone ≤0.0016 mcg, gentamicin sulfate ≤0.15 mcg, ovalbumin ≤0.05 mcg, formaldehyde ≤5 mcg, and sodium deoxycholate ≤50 mcg from the manufacturing process.”

“Worldwide voluntary reports of adverse events received for FLUARIX since market introduction of this vaccine are listed below. This list includes serious events or events which have causal connection to FLUARIX. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to the vaccine. Blood and Lymphatic System Disorders: Lymphadenopathy Cardiac Disorders: Tachycardia. Ear and Labyrinth Disorders: Vertigo. Eye Disorders: Conjunctivitis, eye irritation, eye pain, eye redness, eye swelling, eyelid swelling. Gastrointestinal Disorders: Abdominal pain or discomfort, nausea, swelling of the mouth, throat, and/or tongue. General Disorders and Administration Site Conditions: Asthenia, chest pain, chills, feeling hot, injection site mass, injection site reaction, injection site warmth, body aches. Immune System Disorders: Anaphylactic reaction including shock, anaphylactoid reaction, hypersensitivity, serum sickness. Infections and Infestations: Injection site abscess, injection site cellulitis, pharyngitis, rhinitis, tonsillitis. Musculoskeletal and Connective Tissue Disorders: Pain in extremity. Nervous System Disorders: Convulsion, dizziness, encephalomyelitis, facial palsy, facial paresis, Guillain-Barré syndrome, hypoesthesia, myelitis, neuritis, neuropathy, paresthesia. Respiratory, Thoracic, and Mediastinal Disorders: Asthma, bronchospasm, cough, dyspnea, respiratory distress, stridor. Skin and Subcutaneous Tissue Disorders: Angioedema, erythema, erythema multiforme, facial swelling, pruritus, rash, Stevens-Johnson syndrome, urticaria. Vascular Disorders: Henoch-Schönlein purpura, vasculitis. Immediate and presumably allergic reactions (e.g., hives, angioedema, allergic asthma, and systemic anaphylaxis) rarely occur after influenza vaccination. These reactions probably result from hypersensitivity to certain vaccine components, such as residual egg protein. Although FLUARIX contains only a limited quantity of egg protein, this protein can induce immediate hypersensitivity reactions among persons who have severe egg allergy Neurological disorders temporally associated with influenza vaccination such as encephalopathy, optic neuritis/neuropathy, partial facial paralysis, and brachial plexus neuropathy have been reported. Microscopic polyangitis (vasculitis) has been reported temporally associated with influenza vaccination.”

Flulaval:

“There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, FLULAVAL should be given to a pregnant woman only if clearly needed.”

“It is not known whether FLULAVAL is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when FLULAVAL is administered to a nursing woman.”

“Thimerosal, a mercury derivative, is added as a preservative. Each dose contains 25 mcg mercury. Each dose may also contain residual amounts of egg proteins (≤1 mcg ovalbumin), formaldehyde (≤25 mcg), and sodium deoxycholate (≤50 mcg).”

“Specific levels of HI antibody titer post-vaccination with inactivated influenza virus vaccines have not been correlated with protection from influenza illness but the antibody titers have been used as a measure of vaccine activity. In some human challenge studies, antibody titers of ≥1:40 have been associated with protection from influenza illness in up to 50% of subjects.”

“FLULAVAL has not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility.”

“In addition to reports in clinical trials, the following adverse events have been identified during postapproval use of FLULAVAL. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their incidence rate or establish a causal relationship to the vaccine. Adverse events described here are included because: a) they represent reactions which are known to occur following immunizations generally or influenza immunizations specifically; b) they are potentially serious; or c) the frequency of reporting. Blood and Lymphatic System Disorders: Lymphadenopathy. Eye Disorders: Eye pain, photophobia. Gastrointestinal Disorders: Dysphagia, vomiting. General Disorders and Administration Site Conditions: Chest pain, injection site inflammation, asthenia, injection site rash, influenza-like symptoms, abnormal gait, injection site bruising, injection site sterile abscess. Immune System Disorders: Allergic edema of the mouth, anaphylaxis, allergic edema of the throat. Infections and Infestations: Rhinitis, laryngitis, cellulitis. Musculoskeletal and Connective Tissue Disorders: Muscle weakness, arthritis. Nervous System Disorders: Dizziness, paresthesia, hypoesthesia, hypokinesia, tremor, somnolence, syncope, Guillain-Barré syndrome, convulsions/seizures, facial or cranial nerve paralysis, encephalopathy, limb paralysis. Psychiatric Disorders: Insomnia. Respiratory, Thoracic, and Mediastinal Disorders: Dyspnea, dysphonia, bronchospasm, throat tightness. Skin and Subcutaneous Tissue Disorders: Urticaria, localized or generalized rash, pruritus, sweating. Vascular Disorders: Flushing, pallor. Anaphylaxis has been reported after administration of FLULAVAL. Although FLULAVAL contains only a limited quantity of egg protein, this protein can induce immediate hypersensitivity reactions among persons who have severe egg allergy. Allergic reactions include hives, angioedema, allergic asthma, and systemic anaphylaxis. Neurological disorders temporally associated with influenza vaccination such as encephalopathy, optic neuritis/neuropathy, partial facial paralysis, and brachial plexus neuropathy have been reported. Microscopic polyangitis (vasculitis) has been reported temporally associated with influenza vaccination.”

Afluria:

“Administration of CSL’s 2010 Southern Hemisphere influenza vaccine has been associated with increased postmarketing reports of fever and febrile seizures in children predominantly below the age of 5 years as compared to previous years.”

“Serious allergic reactions, including anaphylactic shock, have been observed during postmarketing surveillance in individuals receiving AFLURIA.”

“Because postmarketing reporting of adverse reactions is voluntary and from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure. The adverse reactions described have been included in this section because they: 1) represent reactions that are known to occur following immunizations generally or influenza immunizations specifically; 2) are potentially serious; or 3) have been reported frequently. These adverse reactions reflect experience in both children and adults and include those identified during post-approval use of AFLURIA outside the US since 1985. Blood and lymphatic system disorders Transient thrombocytopenia Immune system disorders Allergic reactions including anaphylactic shock and serum sickness Nervous system disorders Neuralgia, paresthesia, and convulsions (including febrile seizures); encephalopathy, neuritis or neuropathy, transverse myelitis, and GBS Vascular disorders Vasculitis with transient renal involvement Skin and subcutaneous tissue disorders Pruritus, urticaria, and rash”

“Anaphylaxis has been reported after administration of AFLURIA. Egg protein can induce immediate hypersensitivity reactions among persons who have severe egg allergy. Allergic reactions include hives, angioedema, asthma, and systemic anaphylaxis. Neurological disorders temporally associated with influenza vaccination, such as encephalopathy, optic neuritis/neuropathy, partial facial paralysis, and brachial plexus neuropathy, have been reported. Microscopic polyangiitis (vasculitis) has been reported temporally associated with influenza vaccination.”

“Animal reproduction studies have not been conducted with AFLURIA. It is also not known whether AFLURIA can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. AFLURIA should be given to a pregnant woman only if clearly needed.”

“AFLURIA has not been evaluated in nursing mothers. It is not known whether AFLURIA is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when AFLURIA is administered to a nursing woman.”

“The multi-dose presentation contains thimerosal, added as a preservative; each 0.5 mL dose contains 24.5 mcg of mercury. A single 0.5 mL dose of AFLURIA contains sodium chloride (4.1 mg), monobasic sodium phosphate (80 mcg), dibasic sodium phosphate (300 mcg), monobasic potassium phosphate (20 mcg), potassium chloride (20 mcg), and calcium chloride (1.5 mcg). From the manufacturing process, each 0.5 mL dose may also contain residual amounts of sodium taurodeoxycholate (≤ 10 ppm), ovalbumin (≤ 1 mcg), neomycin sulfate (≤ 3 nanograms [ng]), polymyxin B (≤ 0.5 ng), and beta-propiolactone (≤ 2 ng).”

“Specific levels of hemagglutination inhibition (HI) antibody titers post- vaccination with inactivated influenza virus vaccine have not been correlated with protection from influenza virus. In some human studies, antibody titers of 1:40 or greater have been associated with protection from influenza illness in up to 50% of subjects.”

“AFLURIA has not been evaluated for carcinogenic or mutagenic potential or for impairment of fertility.”

“A total of 1,357 subjects were vaccinated (1,089 subjects with AFLURIA and 268 with a thimerosal-containing placebo).”  (editor’s note – interesting that the test subjects given the placebo still get the mercury)

2011-12_Fluzone_PI

flumist_pi

Fluvirin-UCM123694_NEWPI

us_fluarix

us_flulaval

Package-Insert-Afluria-July2011

jtt7332

msds.php

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I recently filled out a survey for Walgreens.  Enjoy:

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6 comments on “The fine print in the 2011-2012 flu vaccine inserts

  1. A year later, I just found this page. Thanks for the concise flu vax insert info, and for getting in pharma’s face.

    • Oh, you’re welcome. Thx for the comment. I briefly skimmed the 2012-2013 versions. Looks like all the same crap, especially the particularly nasty Triton X 100 in two of them.

  2. While I definitely think it’s a pretty good idea to understand what is going into your body, your opening statement contains half truths that doesn’t accurately cover the reality of the topic. Yes the flu shot has formaldehyde in it. So does: air, soil, food, treated and bottled drinking water, surface water and groundwater. (Fun fact: your own body produces formaldehyde in trace amounts)

    And the toxic mercury you’re referring to is Methyl Mercury. That is very different than the Ethyl Mercury used in multidose vaccinations. Ethyl Mercury acts very differently and does not accumulate in the body like Methyl Mercury. It’s much the same way that ethanol and methanol are very different substances but are both alcohols. It would be like claiming that you shouldn’t drink beer or wine since certain alcohols have been proven to cause blindness.

    Speaking of educating, have a look at the following links:
    http://www.who.int/vaccine_safety/committee/topics/thiomersal/statement_jul2006/en/index.html

    http://www.harpocratesspeaks.com/2012/04/demystifying-vaccine-ingredients.html

    http://gizmodo.com/setting-the-record-straight-debunking-all-the-flu-vacc-1455630807

    Cheers! – Dave Rawlins

    • Some environmental exposure to formaldehyde isn’t the same as injecting it. I’m not sure what half-truths you’re talking about – I mainly just directly quoted from the official inserts. And your info on mercury is disinfo. Both a rat and human study demonstrated that the ethyl mercury is converted into methyl mercury, and then into the inorganic mercury that is retained long term. http://dr-king.com/docs/110915_PGKReviewOfUSSubmissionToUNEP_b.pdf

      Maybe you subscribe to the propagandistic Journal Pediatrics, and Seema Mathur:
      “Mercury-containing vaccines may help, not harm, kids according to two new studies in the Journal Pediatrics. There have been widespread concerns that mercury-based preservatives in vaccines might impair the neurological development of children. These new studies suggest that the opposite – that the preservatives may actually be associated with improved behavior and mental performance.” — Seema Mathur, Medical Watch reporter, KEYE News, CBS

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