Evidence based educational material regarding risk of adverse reaction to a vaccine

October 4, 2017

VACCINATION CHOICE IS A HUMAN RIGHT

Vaccination is a medical intervention performed on a healthy person that has the inherent ability to result in the injury or death of that healthy person. Vaccines come with inherent and unavoidable risks as evidenced in:

Peer-reviewed science

Reported adverse reactions

Vaccine court settlements

Vaccine package inserts

INFORMED CONSENT IS A HUMAN RIGHT

Vaccines are pharmaceutical products with known risks. Informed consent means that you should be given all necessary information when faced with a medical decision for you or your child. In the case of vaccines, this should include risks, benefits and alternatives (including not undergoing the procedure)—and the right to say no, without coercion.

Regarding the immunization schedule for 7th-12th graders in Vermont.

  1. There is evidence of severe, life threatening side effects or, in some cases the risks have not been evaluated, for every vaccine approved by the CDC and required by the Vermont Department of Health for 7th-12th grade students .

“Deaths have been reported following vaccination with measles, mumps, and rubella vaccines; however, a causal relationship has not been established in healthy individuals.” Merck, ProQuad Package Insert, 2017.

“Death from various, and in some cases unknown, causes has been reported rarely following vaccination with measles, mumps, and rubella vaccines; however, a causal relationship has not been established in healthy individuals.” Merck MMR II Package Insert, 2017.

“Deaths have been reported in temporal association with the administration of IPV.”  Sanofi-Pasteur Ipol Package Insert, 2017.

“Long-term studies in animals to evaluate carcinogenic potential or impairment of fertility have not been conducted.” Sanofi-Pasteur Ipol Package Insert, 2017.

“These include bruising more easily than normal; red or purple, flat, pinhead spots under the skin; severe paleness; difficulty walking; severe skin disorders; skin infection; and chickenpox. Rarely, swelling of the brain, stroke, inflammation of the lungs (known as pneumonia or pneumonitis), and seizures with or without a fever have been reported.” Merck, Varivax Package Insert, 2013.

“A review by the Institute of Medicine found evidence for acceptance of a causal relation between tetanus toxoid and both brachial neuritis and Guillain-Barré syndrome.” Sanofi Pasteur, Adacel Package Insert, 2017.

“Hypersensitivity reactions including anaphylactic/anaphylactoid reactions, bronchospasm, and urticaria have been reported within the first few hours after vaccination. An apparent hypersensitivity syndrome (serum-sickness-like) of delayed onset has been reported days to weeks after vaccination, including: arthralgia/arthritis (usually transient), fever, and dermatologic reactions such as urticaria, erythema multiforme, ecchymoses and erythema nodosum. Autoimmune diseases including systemic lupus erythematosus (SLE), lupus-like syndrome, vasculitis, and polyarteritis nodosa have also been reported. Gastrointestinal Disorders Elevation of liver enzymes; constipation Nervous System Disorders Guillain-Barré syndrome; multiple sclerosis; exacerbation of multiple sclerosis; myelitis including transverse myelitis; seizure; febrile seizure; peripheral neuropathy including Bell’s Palsy; radiculopathy; herpes zoster; migraine; muscle weakness; hypesthesia; encephalitis Skin and Subcutaneous Disorders Stevens-Johnson syndrome; alopecia; petechiae; eczema Musculoskeletal and Connective Tissue Disorders Arthritis Pain in extremity Blood and Lymphatic System Disorders Increased erythrocyte sedimentation rate; thrombocytopenia Psychiatric Disorders Irritability; agitation; somnolence Eye Disorders Optic neuritis; tinnitus; conjunctivitis; visual disturbances; uveitis Cardiac Disorders Syncope; tachycardia” Merck, RecombiVax HB Package Insert, 2017.

“This list includes serious adverse events or events that have a suspected causal connection to components of ENGERIX-B. Because these events are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to the vaccine. Infections and Infestations Herpes zoster, meningitis. Blood and Lymphatic System Disorders Thrombocytopenia. Immune System Disorders Allergic reaction, anaphylactoid reaction, anaphylaxis. An apparent hypersensitivity syndrome (serum sickness-like) of delayed onset has been reported days to weeks after vaccination,  including: arthralgia/arthritis (usually transient), fever, and dermatologic reactions such as urticaria, erythema multiforme, ecchymoses, and erythema nodosum. Nervous System Disorders  Encephalitis, encephalopathy, migraine, multiple sclerosis, neuritis, neuropathy including hypoesthesia, paresthesia, Guillain-Barré syndrome and Bell’s palsy, optic neuritis, paralysis, paresis, seizures, syncope, transverse myelitis. Eye Disorders Conjunctivitis, keratitis, visual disturbances. Ear and Labyrinth Disorders Earache, tinnitus, vertigo. Cardiac Disorders Palpitations, tachycardia.  Vascular Disorders Vasculitis. Respiratory, Thoracic, and Mediastinal Disorders Apnea, bronchospasm including asthma-like symptoms. Gastrointestinal Disorders Dyspepsia. Skin and Subcutaneous Tissue Disorders Alopecia, angioedema, eczema, erythema multiforme including Stevens-Johnson syndrome, erythema nodosum, lichen planus, purpura.  Musculoskeletal and Connective Tissue Disorders Arthritis, muscular weakness.” Glaxo Smith Kline Engerix Package Insert, 2017. 

 

  1. There is evidence that mutant strains of bacteria are reducing the efficacy of certain vaccines, such as those that are marketed for pertussis.  “The strains of Bordetella pertussis that are pertactin-deficient have increased from 14% in 2010 to 85% in 2012.” http://www.aappublications.org/news/2016/04/18/evolution-and-efficacy-of-pertactin-deficient-pertussus-vaccination-pediatrics-0416Evolution and Efficacy of Pertactin-Deficient Pertussis VaccinationDr Joann Schulte, DO, MPH, Amaerican Academy of Pediatrics, Journals BlogApril 18, 2016.

 

  1. There is evidence that aluminum adjuvants, which are ingredients in many vaccines, are not adequately tested for safety. “Efforts have been done in the last years to develop novel adjuvants, but attempts to seriously examine safety concerns raised by the bio-persistent character and brain accumulation of alum particles have not been made.” Source: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4318414/, Biopersistence and Brain Translocation of Aluminum Adjuvants of Vaccines,Romain Kroum Gherardi, Housam Eidi, Guillemette Crépeaux, François Jerome Authier, and Josette Cadusseau, Frontiers in Neurology, PMCID: PMC4318414.

Compiled by: Dexter Lefavour PE, of Middlesex, Vermont.

*Editor’s note: Check the facts for yourself. Find the latest prescribing information (package inserts), including adverse reaction warnings, for each and every vaccine, here.

On its website, the Vermont Department of Health says: “Parents should be able to make informed decisions based on accurate information.”

We agree. There is no excuse for failing to warn consumers.