Examples of Labeled Vaccine Risks

From vaccine label warnings, one can plainly see that there is evidence of severe, life threatening side effects or, in some cases the risks have not been evaluated, for every vaccine mandated by the State of Vermont for day care, PreK-12 and college enrollment (unless parent files religious exemption).

Examples of Labeled Vaccine Risks:

  • “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[1].
  • “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[2].
  • “Deaths have been reported in temporal association with the administration of IPV.” – Sanofi-Pasteur Ipol Package Insert, 2017[3].
  • “Long-term studies in animals to evaluate carcinogenic potential or impairment of fertility have not been conducted.” Sanofi-Pasteur Ipol Package Insert, 2017[4].
  • “A total of 5 deaths occurred during … 4 in children who had received Pentacel…Causes of death among children who received Pentacel were asphyxia due to suffocation, head trauma, Sudden Infant Death syndrome, and neuroblastoma…”- Sanofi Pasteur, Pentacel Package Insert, 2017[5].
  • “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[6].
  • “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[7].
  • “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[8].
  • “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 Energerix Package Insert, 2017[9].

[1] https://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm188806.htm

[2] https://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM123789.pdf

[3] https://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm180053.htm

[4] https://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm180053.htm

[5] https://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM109810.pdf

[6] https://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM142813.pdf

[7] https://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm172481.htm

[8] https://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM110114.pdf

[9] https://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM224503.pdf