National Academies Press: OpenBook

Adverse Effects of Vaccines: Evidence and Causality (2012)

Chapter: Appendix D: Causality Conclusion Tables

« Previous: Appendix C: Literature Search Strategy
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×

TABLE D-1 Causality Conclusions Organized by Chapter and Adverse Event

Chapter Vaccine Adverse Event Epidemiologic Assessment Mechanistic Assessment Causality Conclusion
4 MMR Measles Inclusion Body Encephalitis Insufficient Strong (measles; in individuals with demonstrated immunodeficiencies) Lacking (mumps or rubella) Convincingly Supportsa (in individuals with demonstrated immunodeficiencies)
4 MMR Encephalitis Limited Weak Inadequate
4 MMR Encephalopathy Limited Weak Inadequate
4 MMR Febrile Seizures High (increase) Intermediate Convincingly Supports
4 MMR Afebrile Seizures Limited Lacking Inadequate
4 MMR Meningitisb Moderate (null) Weak (mumps) Lacking (measles or rubella) Inadequate
4 MMR Ataxia Insufficient Weak (measles or mumps) Lacking (rubella) Inadequate
4 MMR Autism High (null) Lacking Favors Rejection
4 MMR Acute Disseminated Encephalomyelitis Insufficient Weak Inadequate
4 MMR Transverse Myelitis Insufficient Weak Inadequate
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
4 MMR Optic Neuritis,b Limited Weak Inadequate
4 MMR Neuromyelitis Opticab Insufficient Weak (rubella) Lacking (measles or mumps) Inadequate
4 MMR Multiple Sclerosis Onset in Adults Limited Lacking Inadequate
4 MMR Multiple Sclerosis Onset in Children Limited Lacking Inadequate
4 MMR Guillain-Barré syndrome Insufficient Weak Inadequate
4 MMR Chronic Inflammatory Disseminated Polyneuropathy Insufficient Lacking Inadequate
4 MMR Opsoclonus Myoclonus Syndrome Insufficient Lacking Inadequate
4 MMR Brachial Neuritis Insufficient Inadequate
4 MMR Anaphylaxis Insufficient Strong Convincingly Supports
4 MMR Transient Arthralgia in Women Moderate (increase) (rubella) Insufficient (measles or mumps) Intermediate (rubella) Lacking (measles or mumps) Favors Acceptance
4 MMR Transient Arthralgia in Children Moderate (increase) Weak (rubella) Lacking (measles or mumps) Favors Acceptancec
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Chapter Vaccine Adverse Event Epidemiologic Assessment Mechanistic Assessment Causality Conclusion
4 MMR Chronic Arthralgia in Women Limited (rubella) Insufficient (measles or mumps) Low-Intermediate (rubella) Lacking (measles or mumps) Inadequate
4 MMR Chronic Arthritis in Women Limited (rubella) Insufficient (measles or mumps) Low-Intermediate (rubella) Lacking (measles or mumps) Inadequate
4 MMR Chronic Arthropathy in Children Insufficient Weak (rubella) Lacking (measles or mumps) Inadequate
4 MMR Arthropathy in Men Limited Weak (rubella) Lacking (measles or mumps) Inadequate
4 MMR Type 1 Diabetes High (null) Lacking Favors Rejection
4 MMR Hepatitis Insufficient Weak Inadequate
4 MMR Chronic Fatigue Syndrome Insufficient Lacking Inadequate
4 MMR Fibromyalgia Insufficient Lacking Inadequate
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
4 MMR Hearing Loss Insufficient Low-Intermediate (measles or mumps) Lacking (rubella) Inadequate
5 Disseminated Oka VZV without Other Organ Involvement Insufficient Varicella Strong Convincingly Supports
5 Disseminated Oka VZV with Subsequent Infection Resulting in Pneumonia, Meningitis, or Hepatitis Limited (subsequent infection resulting in pneumonia) Insufficient (subsequent infection resulting in meningitis or hepatitis) Varicella Strong (in individuals with demonstrated immunodeficiencies) Convincingly Supports (in individuals with demonstrated immunodeficiencies)
5 Vaccine Strain Viral Reactivation without Other Organ Involvement Insufficient Varicella Strong Convincingly Supports
5 Vaccine Strain Viral Reactivation with Subsequent Infection resulting in Meningitis or Encephalitis Limited (subsequent infection resulting in encephalitis) Insufficient (subsequent infection resulting in meningitis) Varicella Strong Convincingly Supports
5 Encephalopathy Insufficient Varicella Lacking Inadequate
5 Seizures Limited Varicella Weak Inadequate
5 Cerebellar Ataxia Insufficient Varicella Weak Inadequate
5 Acute Disseminated Encephalomyelitis Insufficient Varicella Weak Inadequate
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Chapter Vaccine Adverse Event Epidemiologic Assessment Mechanistic Assessment Causality Conclusion
5 Varicella Transverse Myelitis Insufficient Weak Inadequate
5 Varicella Guillain-Barre syndrome Insufficient Weak Inadequate
5 Varicella Small Fiber Neuropathyb Insufficient Lacking Inadequate
5 Varicella Anaphylaxis Limited Strong Convincingly Supports
5 Varicella Onset or Exacerbation Arthropathy Insufficient Lacking Inadequate
5 Varicella Strokeb Limited Weak Inadequate
5 Varicella Thrombocytopenia Insufficient Weak Inadequate
6 Influenza Encephalitis Insufficient Weak Inadequate
6 Influenza Encephalopathy Insufficient Weak Inadequate
6 Influenza Seizuresb Moderate (null) Lacking Inadequate
6 Influenza Acute Disseminated Encephalomyelitis Insufficient Weak Inadequate
6 Influenza Transverse Myelitis Insufficient Weak Inadequate
6 Influenza Optic Neuritisb Limited Weak Inadequate
6 Influenza Neuromyelitis Optica Insufficient Lacking Inadequate
6 Influenza Multiple Sclerosis Onset in Adults Limited Lacking Inadequate
6 Influenza Multiple Sclerosis Relapse in Adults Limited Lacking Inadequate
6 Influenza Guillain-Barre syndrome Moderate (null) Weak Inadequate
6 Influenza Chronic Inflammatory Disseminated Polyneuropathy Insufficient Weak Inadequate
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
6 Influenza Inactivated Influenza Vaccine and Bell’s Palsy High (null) Lacking Favors Rejection
6 Influenza Brachial Neuritis Insufficient Lacking Inadequate
6 Influenza Small Fiber Neuropathy Insufficient Lacking Inadequate
6 Influenza Anaphylaxis Limited Strong Convincingly Supports
6 Influenza Inactivated Influenza Vaccine and Asthma Exacerbation or Reactive Airway Disease Episodes in Children and Adults High (null) Weak Favors Rejection
6 Influenza Live Attenuated Influenza Vaccine or Asthma Exacerbation or Reactive Airway Disease Episodes in Children Younger Than 5 Years of Age Moderate (null) Weak Inadequate
6 Influenza Live Attenuated Influenza Vaccine or Asthma Exacerbation or Reactive Airway Disease Episodes in Persons 5 Years of Age or Older Moderate (null) Weak Inadequate
6 Influenza Onset or Exacerbation of Systemic Lupus Erythematosus Limited (exacerbation) Insufficient (onset) Lacking Inadequate
6 Influenza Onset or Exacerbation of Vasculitis Limited (exacerbation) Insufficient (onset) Weak (exacerbation) Lacking (onset) Inadequate
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Chapter Vaccine Adverse Event Epidemiologic Assessment Mechanistic Assessment Causality Conclusion
6 Influenza Polyarteritis Nodosa Insufficient Lacking Inadequate
6 Influenza Onset or Exacerbation of Arthropathy Insufficient Weak Inadequate
6 Influenza Stroke Moderate (decrease) Lacking Inadequate
6 Influenza Myocardial Infarction Moderate (decrease) Weak (Live Attenuated Influenza Vaccine) Lacking (Inactivated Influenza Vaccine) Inadequate
6 Influenza Fibromyalgia Insufficient Lacking Inadequate
6 Influenza All-Cause Mortalityb Moderate (decrease) Weak (Live Attenuated Influenza Vaccine) Lacking (Inactivated Influenza Vaccine) Inadequate
6 Influenza Oculorespiratory Syndrome Moderate (increase)d Intermediated Favors Acceptanced
Hepatitis A Acute Disseminated Encephalomyelitis Insufficient Weak Inadequate
Hepatitis A Transverse Myelitis Insufficient Weak Inadequate
7 Hepatitis A Multiple Sclerosis Insufficient Lacking Inadequate
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
7 Hepatitis A Guillain-Barré syndrome Insufficient Weak Inadequate
Hepatitis A Chronic Inflammatory Disseminated Polyneuropathy Insufficient Lacking Inadequate
7 Hepatitis A Bell’s Palsy Insufficient Lacking Inadequate
7 Hepatitis A Anaphylaxis Insufficient Weak Inadequate
7 Hepatitis A Autoimmune Hepatitis Insufficient Weak Inadequate
8 Hepatitis B Encephalitis Insufficient Lacking Inadequate
8 Hepatitis B Encephalopathy Insufficient Lacking Inadequate
8 Hepatitis B Seizures Limited Lacking Inadequate
8 Hepatitis B Acute Disseminated Encephalomyelitis Insufficient Low-Intermediate Inadequate
8 Hepatitis B Transverse Myelitis Insufficient Weak Inadequate
8 Hepatitis B Optic Neuritisb Limited Lacking Inadequate
8 Hepatitis B Neuromyelitis Optica Insufficient Lacking Inadequate
8 Hepatitis B Multiple Sclerosis Onset in Adults Limited Lacking Inadequate
8 Hepatitis B Multiple Sclerosis Onset in Children Limited Lacking Inadequate
8 Hepatitis B Multiple Sclerosis Relapse in Adults Limited Lacking Inadequate
8 Hepatitis B Multiple Sclerosis Relapse in Children Limited Lacking Inadequate
8 Hepatitis B First Demyelinating Event in Adults Moderate (null) Low-Intermediate Inadequate
8 Hepatitis B First Demyelinating Event in Children Limited Lacking Inadequate
8 Hepatitis B Guillain-Barre syndrome Insufficient Lacking Inadequate
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Chapter Vaccine Adverse Event Epidemiologic Assessment Mechanistic Assessment Causality Conclusion
8 Hepatitis B Chronic Inflammatory Disseminated Polyneuropathy Insufficient Lacking Inadequate
8 Hepatitis B Brachial Neuritis Insufficient Lacking Inadequate
8 Hepatitis B Anaphylaxis Insufficient Strong (in yeast-sensitive individuals) Convincingly Supports (in yea st-sensitive individuals)
8 Hepatitis B Erythema Nodosumb Insufficient Weak Inadequate
8 Hepatitis B Onset or Exacerbation of Systemic Lupus Erythematosus Limited (onset) Insufficient (exacerbation) Weak Inadequate
8 Hepatitis B Onset or Exacerbation of Vasculitis Insufficient Low-Intermediate Inadequate
8 Hepatitis B Onset or Exacerbation of Polyarteritis Nodosa Insufficient Weak Inadequate
8 Hepatitis B Onset or Exacerbation of Psoriatic Arthritis Insufficient Lacking Inadequate
8 Hepatitis B Onset or Exacerbation of Reactive Arthritis Insufficient Weak Inadequate
8 Hepatitis B Onset and Exacerbation of Rheumatoid Arthritis Limited (exacerbation) Insufficient (onset) Weak Inadequate
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
8 Hepatitis B Onset or Exacerbation of Juvenile Idiopathic Arthritis Insufficient Weak Inadequate
8 Hepatitis B Type 1 Diabetes Moderate (null) Lacking Inadequate
8 Hepatitis B Fibromyalgia Insufficient Lacking Inadequate
9 HPV Acute Disseminated Encephalomyelitis Insufficient Lacking Inadequate
9 HPV Transverse Myelitis Insufficient Lacking Inadequate
9 HPV Neuromyelitis Optica Insufficient Lacking Inadequate
9 HPV Multiple Sclerosis Insufficient Lacking Inadequate
9 HPV Guillain-Barre syndrome Insufficient Lacking Inadequate
9 HPV Chronic Inflammatory Disseminated Polyneuropathy Insufficient Lacking Inadequate
9 HPV Brachial Neuritis Insufficient Lacking Inadequate
9 HPV Amyotrophic Lateral Sclerosis Insufficient Lacking Inadequate
9 HPV Anaphylaxis Insufficient Intermediate Favors Acceptance
9 HPV Transient Arthralgia Limited Lacking Inadequate
9 HPV Pancreatitis Insufficient Lacking Inadequate
9 HPV Thromboembolic Events Insufficient Lacking Inadequate
9 HPV Hypercoagulable States Insufficient Lacking Inadequate
10 DT, TT, or aP containing Encephalitis Limited Weak Inadequate
10 DT, TT, or aP containing Encephalopathy Limited Weak Inadequate
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Chapter Vaccine Adverse Event Epidemiologic Assessment Mechanistic Assessment Causality Conclusion
10 DT, TT, or aP containing Infantile Spasms Limited (diphtheria toxoid or tetanus toxoid) Insufficient (acellular pertussis) Lacking Inadequate
10 DT, TT, or aP containing Seizures Limited III Inadequate
10 DT, TT, or aP containing Ataxia Insufficient Lacking Inadequate
10 DT, TT, or aP containing Autism Insufficient Lacking Inadequate
10 DT, TT, or aP containing Acute Disseminated Encephalomyelitis Insufficient Weak (tetanus toxoid) Lacking (diphtheria toxoid or acellular pertussis) Inadequate
10 DT, TT, or aP containing Transverse Myelitis Insufficient Lacking Inadequate
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
10 DT, TT, or aP containing Optic Neuritisb Limited (diphtheria toxoid or tetanus toxoid) Insufficient (acellular pertussis) Lacking Inadequate
10 DT, TT, or aP containing Multiple Sclerosis Onset in Adults Limited (diphtheria toxoid or tetanus toxoid) Insufficient (acellular pertussis) Lacking Inadequate
10 DT, TT, or aP containing Multiple Sclerosis Relapse in Adults Limited (tetanus toxoid) Insufficient (diphtheria toxoid or acellular pertussis) Lacking Inadequate
10 DT, TT, or aP containing Multiple Sclerosis Relapse in Children Limited (diphtheria toxoid or tetanus toxoid) Insufficient (acellular pertussis) Lacking Inadequate
10 DT, TT, or aP containing Guillain-Barre syndrome Insufficient Lacking Inadequate
10 DT, TT, or aP containing Chronic Inflammatory Disseminated Polyneuropathy Insufficient Lacking Inadequate
10 DT, TT, or aP containing Opsoclonus Myoclonus Syndrome Insufficient Lacking Inadequate
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Chapter Vaccine Adverse Event Epidemiologic Assessment Mechanistic Assessment Causality Conclusion
10 DT, TT, or aP containing Bell’s Palsy Limited (acel hilar pertussis) Insufficient (diphtheria toxoid or tetanus toxoid) Weak (diphtheria toxoid or tetanus toxoid) Lacking (acellular pertussis) Inadequate
10 TT containing Anaphylaxis Insufficient Strong Convincingly Supports
10 DT and aP containing Anaphylaxis Insufficient Lacking Inadequate
10 DT, TT, or aP containing Chronic Urticaria Insufficient Lacking Inadequate
10 DT, TT, or aP containing Serum Sickness Insufficient Weak (diphtheria toxoid or tetanus toxoid) Lacking (acellular pertussis) Inadequate
10 DT, TT, or aP containing Arthropathy Limited (diphtheria toxoid or tetanus toxoid) Insufficient (acellular pertussis) Lacking Inadequate
10 DT, TT, or aP containing Type 1 Diabetes High (null) Lacking Favors Rejection
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
10 DT, TT, or aP containing Myocarditis Insufficient Weak (diphtheria toxoid) Lacking (tetanus toxoid or acellular pertussis) Inadequate
10 DT, TT, or aP containing Fibromyalgia Insufficient Lacking Inadequate
10 DT, TT, or aP containing Sudden Infant Death Syndrome Insufficient Lacking Inadequate
10 DT, TT, or aP containing Immune Thrombocytopenic Purpura Insufficient Lacking Inadequate
Meningococcal Encephalitis Limited Lacking Inadequate
Meningococcal Encephalopathy Limited Lacking Inadequate
Meningococcal Acute Disseminated Encephalomyelitis Insufficient Lacking Inadequate
Meningococcal Transverse Myelitis Insufficient Lacking Inadequate
Meningococcal Multiple Sclerosis Insufficient Lacking Inadequate
Meningococcal Guillain-Barre syndrome Limited Lacking Inadequate
Meningococcal Chronic Inflammatory Disseminated Polyneuropathy Insufficient Lacking Inadequate
Meningococcal Anaphylaxis Insufficient Strong Convincingly Supports
Meningococcal Chronic Headache Insufficient Lacking Inadequate
12 Injection-Related Event Complex Regional Pain Syndrome Insufficient Low-Intermediate Inadequate
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Chapter Vaccine Adverse Event Epidemiologic Assessment Mechanistic Assessment Causality Conclusion
12 Injection-Related Event Deltoid Bursitis Limited Strong Convincingly Supports
12 Injection-Related Event Syncope Insufficient Strong Convincingly Supports

NOTE: The measles-mumps-rubella; human papillomavirus; and diphtheria toxoid–, tetanus toxoid-, and acellular pertussis-containing vaccines have been abbreviated in the following ways: MMR; HPV; and DT, TT, and aP containing.

   aThe committee attributes causation to the measles component of the vaccine.

   bAlthough not originally charged to the committee by the sponsor, the committee considered this adverse event in its review of the literature.

   cThe committee attributes causation to the rubella component of the vaccine.

   dThe committee attributes causation to two particular vaccines used in three particular years in Canada.

Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×

TABLE D-2 Causality Conclusions Organized by Adverse Event and Chapter

Chapter Vaccine Adverse Event Epidemiologic Assessment Mechanistic Assessment Causality Conclusion
5 Varicella Disseminated Oka VZV without Other Organ Involvement Insufficient Strong Convincingly Supports
5 Varicella Disseminated Oka VZV with Subsequent Infection Resulting in Pneumonia, Meningitis, or Hepatitis Limited (subsequent infection resulting in pneumonia)
Insufficient (subsequent infection resulting in meningitis or hepatitis)
Strong (in individuals with demonstrated immunodeficiencies) Convincingly Supports (in individuals with demonstrated immunodeficiencies)
5 Varicella Vaccine Strain Viral Reactivation without Other Organ Involvement Insufficient Strong Convincingly Supports
5 Varicella Vaccine Strain Viral Reactivation with Subsequent Infection resulting in Meningitis or Encephalitis Limited (subsequent infection resulting in encephalitis) Insufficient (subsequent infection resulting in meningitis) Strong Convincingly Supports
4 MMR Measles Inclusion Body Encephalitis Insufficient Strong (measles; in individuals with demonstrated immunodeficiencies) Lacking (mumps or rubella) Convincingly Supportsa (in individuals with demonstrated immunodeficiencies)
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
4 MMR Encephalitis Limited Weak Inadequate
6 Influenza Encephalitis Insufficient Weak Inadequate
8 Hepatitis B Encephalitis Insufficient Lacking Inadequate
10 DT, TT, or aP containing Encephalitis Limited Weak Inadequate
11 Meningococcal Encephalitis Limited Lacking Inadequate
4 MMR Encephalopathy Limited Weak Inadequate
5 Varicella Encephalopathy Insufficient Lacking Inadequate
6 Influenza Encephalopathy Insufficient Weak Inadequate
8 Hepatitis B Encephalopathy Insufficient Lacking Inadequate
10 DT, TT, or aP containing Encephalopathy Limited Weak Inadequate
11 Meningococcal Encephalopathy Limited Lacking Inadequate
10 DT, TT, or aP containing Infantile Spasms Limited (diphtheria toxoid or tetanus toxoid) Insufficient (acellular pertussis) Lacking Inadequate
4 MMR Febrile Seizures High (increase) Intermediate Convincingly Supports
4 MMR Afebrile Seizures Limited Lacking Inadequate
5 Varicella Seizures Limited Weak Inadequate
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
6 Influenza Seizuresb Moderate (null) Lacking Inadequate
8 Hepatitis B Seizures Limited Lacking Inadequate
10 DT, TT, or aP containing Seizures Limited Weak (acellular pertussis) Lacking (diphtheria toxoid or tetanus toxoid) Inadequate
4 MMR Meningitisb Moderate (null) Weak (mumps) Lacking (measles or rubella) Inadequate
5 Varicella Cerebellar Ataxia Insufficient Weak Inadequate
4 MMR Ataxia Insufficient Weak (measles or mumps) Lacking (rubella) Inadequate
10 DT, TT, or aP containing Ataxia Insufficient Lacking Inadequate
4 MMR Autism High (null) Lacking Favors Rejection
10 DT, TT, or aP containing Autism Insufficient Lacking Inadequate
4 MMR Acute Disseminated Encephalomyelitis Insufficient Weak Inadequate
5 Varicella Acute Disseminated Encephalomyelitis Insufficient Weak Inadequate
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Chapter Vaccine Adverse Event Epidemiologic Assessment Mechanistic Assessment Causality Conclusion
6 Influenza Acute Disseminated Encephalomyelitis Insufficient Weak Inadequate
7 Hepatitis A Acute Disseminated Encephalomyelitis Insufficient Weak Inadequate
8 Hepatitis B Acute Disseminated Encephalomyelitis Insufficient Low-Intermediate Inadequate
9 HPV Acute Disseminated Encephalomyelitis Insufficient Lacking Inadequate
10 DT, TT, or aP containing Acute Disseminated Encephalomyelitis Insufficient Weak (tetanus toxoid) Lacking (diphtheria toxoid or acellular pertussis) Inadequate
11 Meningococcal Acute Disseminated Encephalomyelitis Insufficient Lacking Inadequate
4 MMR Transverse Myelitis Insufficient Weak Inadequate
5 Varicella Transverse Myelitis Insufficient Weak Inadequate
6 Influenza Transverse Myelitis Insufficient Weak Inadequate
7 Hepatitis A Transverse Myelitis Insufficient Weak Inadequate
8 Hepatitis B Transverse Myelitis Insufficient Weak Inadequate
9 HPV Transverse Myelitis Insufficient Lacking Inadequate
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
10 DT, TT, or aP containing Transverse Myelitis Insufficient Lacking Inadequate
11 Meningococcal Transverse Myelitis Insufficient Lacking Inadequate
4 MMR Optic Neuritisb Limited Weak Inadequate
6 Influenza Optic Neuritisb Limited Weak Inadequate
8 Hepatitis B Optic Neuritisb Limited Lacking Inadequate
10 DT, TT, or aP containing Optic Neuritisb Limited (diphtheria toxoid or tetanus toxoid) Insufficient (acellular pertussis) Lacking Inadequate
4 MMR Neuromyelitis Opticab Insufficient Weak (rubella) Lacking (measles or mumps) Inadequate
6 Influenza Neuromyelitis Optica Insufficient Lacking Inadequate
8 Hepatitis B Neuromyelitis Optica Insufficient Lacking Inadequate
9 HPV Neuromyelitis Optica Insufficient Lacking Inadequate
4 MMR Multiple Sclerosis Onset in Adults Limited Lacking Inadequate
6 Influenza Multiple Sclerosis Onset in Adults Limited Lacking Inadequate
8 Hepatitis B Multiple Sclerosis Onset in Adults Limited Lacking Inadequate
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Chapter Vaccine Adverse Event Epidemiologic Assessment Mechanistic Assessment Causality Conclusion
10 DT, TT, or aP containing Multiple Sclerosis Onset in Adults Limited (diphtheria toxoid or tetanus toxoid) Insufficient acellular pertussis) Lacking Inadequate
4 MMR Multiple Sclerosis Onset in Children Limited Lacking Inadequate
8 Hepatitis B Multiple Sclerosis Onset in Children Limited Lacking Inadequate
6 Influenza Multiple Sclerosis Relapse in Adults Limited Lacking Inadequate
8 Hepatitis B Multiple Sclerosis Relapse in Adults Limited Lacking Inadequate
10 DT, TT, or aP containing Multiple Sclerosis Relapse in Adults Limited (tetanus toxoid) Insufficient (diphtheria toxoid or acellular pertussis) Lacking Inadequate
8 Hepatitis B Multiple Sclerosis Relapse in Children Limited Lacking Inadequate
10 DT, TT, or aP containing Multiple Sclerosis Relapse in Children Limited (diphtheria toxoid or tetanus toxoid) Insufficient (acellular pertussis) Lacking Inadequate
7 Hepatitis A Multiple Sclerosis Insufficient Lacking Inadequate
9 HPV Multiple Sclerosis Insufficient Lacking Inadequate
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
11 Meningococcal Multiple Sclerosis Insufficient Lacking Inadequate
8 Hepatitis B First Demy el ina ting Event in Adults Moderate (null) Low-Intermediate Inadequate
8 Hepatitis B First Demyel ina ting Event in Children Limited Lacking Inadequate
4 MMR Guillain-Barre syndrome Insufficient Weak Inadequate
5 Varicella Guillain-Barre syndrome Insufficient Weak Inadequate
6 Influenza Guillain-Barre syndrome Moderate (null) Weak Inadequate
7 Hepatitis A Guillain-Barre syndrome Insufficient Weak Inadequate
8 Hepatitis B Guillain-Barre syndrome Insufficient Lacking Inadequate
9 HPV Guillain-Barre syndrome Insufficient Lacking Inadequate
10 DT, TT, or aP containing Guillain-Barre syndrome Insufficient Lacking Inadequate
11 Meningococcal Guillain-Barre syndrome Limited Lacking Inadequate
4 MMR Chronic Inflammatory Disseminated Polyneuropathy Insufficient Lacking Inadequate
6 Influenza Chronic Inflammatory Disseminated Polyneuropathy Insufficient Weak Inadequate
7 Hepatitis A Chronic Inflammatory Disseminated Polyneuropathy Insufficient Lacking Inadequate
8 Hepatitis B Chronic Inflammatory Disseminated Polyneuropathy Insufficient Lacking Inadequate
9 HPV Chronic Inflammatory Disseminated Polyneuropathy Insufficient Lacking Inadequate
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Chapter Vaccine Adverse Event Epidemiologic Assessment Mechanistic Assessment Causality Conclusion
10 DT, TT, or aP containing Chronic Inflammatory Disseminated Polyneuropathy Insufficient Lacking Inadequate
11 Meningococcal Chronic Inflammatory Disseminated Polyneuropathy Insufficient Lacking Inadequate
4 MMR Opsoclonus Myoclonus Syndrome Insufficient Lacking Inadequate
10 DT, TT, or aP containing Opsoclonus Myoclonus Syndrome Insufficient Lacking Inadequate
7 Hepatitis A Bell’s Palsy Insufficient Lacking Inadequate
10 DT, TT, or aP containing Bell’s Palsy Limited (acellular pertussis) Insufficient (diphtheria toxoid or tetanus toxoid) Weak (diphtheria toxoid or tetanus toxoid) Lacking (acellular pertussis) Inadequate
6 Influenza Inactivated Influenza Vaccine and Bell’s Palsy High (null) Lacking Favors Rejection
4 MMR Brachial Neuritis Insufficient Lacking Inadequate
6 Influenza Brachial Neuritis Insufficient Lacking Inadequate
8 Hepatitis B Brachial Neuritis Insufficient Lacking Inadequate
9 HPV Brachial Neuritis Insufficient Lacking Inadequate
9 HPV Amyotrophic Lateral Sclerosis Insufficient Lacking Inadequate
5 Varicella Small Fiber Neuropathy6 Insufficient Lacking Inadequate
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
6 Influenza Small Fiber Neuropathy Insufficient Lacking Inadequate
4 MMR Anaphylaxis Insufficient Strong Convincingly Supports
5 Varicella Anaphylaxis Limited Strong Convincingly Supports
6 Influenza Anaphylaxis Limited Strong Convincingly Supports
7 Hepatitis A Anaphylaxis Insufficient Weak Inadequate
8 Hepatitis B Anaphylaxis Insufficient Strong (in yeast-sensitive individuals) Convincingly Supports (in yea st-sensitive individuals)
9 HPV Anaphylaxis Insufficient Intermediate Favors Acceptance
10 DT and aP containing Anaphylaxis Insufficient Lacking Inadequate
10 TT containing Anaphylaxis Insufficient Strong Convincingly Supports
11 Meningococcal Anaphylaxis Insufficient Strong Convincingly Supports
10 DT, TT, or aP containing Chronic Urticaria Insufficient Lacking Inadequate
10 DT, TT, or aP containing Serum Sickness Insufficient Weak (diphtheria toxoid or tetanus toxoid) Lacking (acellular pertussis) Inadequate
6 Influenza Inactivated Influenza Vaccine and Asthma Exacerbation or Reactive Airway Disease Episodes in Children and Adults High (null) Weak Favors Rejection
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Chapter Vaccine Adverse Event Epidemiologic Assessment Mechanistic Assessment Causality Conclusion
6 Influenza Live Attenuated Influenza Vaccine or Asthma Exacerbation or Reactive Airway Disease Episodes in Children Younger Than 5 Years of Age Moderate (null) Weak Inadequate
6 Influenza Live Attenuated Influenza Vaccine or Asthma Exacerbation or Reactive Airway Disease Episodes in Persons 5 Years of Age or Older Moderate (null) Weak Inadequate
8 Hepatitis B Erythema Nodosumb Insufficient Weak Inadequate
6 Influenza Onset or Exacerbation of Systemic Lupus Erythematosus Limited (exacerbation) Insufficient (onset) Lacking Inadequate
8 Hepatitis B Onset or Exacerbation of Systemic Lupus Erythematosus Limited (onset) Insufficient (exacerbation) Weak Inadequate
6 Influenza Onset or Exacerbation of Vasculitis Limited (exacerbation) Insufficient (onset) Weak (exacerbation) Lacking (onset) Inadequate
8 Hepatitis B Onset or Exacerbation of Vasculitis Insufficient Low-Intermediate Inadequate
6 Influenza Polyarteritis Nodosa Insufficient Lacking Inadequate
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
8 Hepatitis B Onset or Exacerbation of Polyarteritis Nodosa Insufficient Weak Inadequate
8 Hepatitis B Onset or Exacerbation of Psoriatic Arthritis Insufficient Lacking Inadequate
8 Hepatitis B Onset or Exacerbation of Reactive Arthritis Insufficient Weak Inadequate
8 Hepatitis B Onset and Exacerbation of Rheumatoid Arthritis Limited (exacerbation) Insufficient (onset) Weak Inadequate
8 Hepatitis B Onset or Exacerbation of Juvenile Idiopathic Arthritis Insufficient Weak Inadequate
4 MMR Transient Arthralgia in Women Moderate (increase) (rubella) Insufficient (measles or mumps) Intermediate (rubella) Lacking (measles or mumps) Favors Acceptancec
4 MMR Transient Arthralgia in Children Moderate (increase) Weak (rubella) Lacking (measles or mumps) Favors Acceptance
9 HPV Transient Arthralgia Limited Lacking Inadequate
4 MMR Chronic Arthralgia in Women Limited (rubella) Insufficient (measles or mumps) Low-Intermediate (rubella) Lacking (measles or mumps) Inadequate
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Chapter Vaccine Adverse Event Epidemiologic Assessment Mechanistic Assessment Causality Conclusion
4 MMR Chronic Arthritis in Women Limited (rubella) Insufficient (measles or mumps) Low-Intermediate (rubella) Lacking (measles or mumps) Inadequate
4 MMR Chronic Arthropathy in Children Insufficient Weak (rubella) Lacking (measles or mumps) Inadequate
4 MMR Arthropathy in Men Limited Weak (rubella) Lacking (measles or mumps) Inadequate
5 Varicella Onset or Exacerbation Arthropathy Insufficient Lacking Inadequate
6 Influenza Onset or Exacerbation of Arthropathy Insufficient Weak Inadequate
10 DT, TT, or aP containing Arthropathy Limited (diphtheria toxoid or tetanus toxoid) Insufficient (acellular pertussis) Lacking Inadequate
4 MMR Type 1 Diabetes High (null) Lacking Favors Rejection
8 Hepatitis B Type 1 Diabetes Moderate (null) Lacking Inadequate
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
10 DT, TT, or aP containing Type 1 Diabetes High (null) Lacking Favors Rejection
7 Hepatitis A Autoimmune Hepatitis Insufficient Weak Inadequate
10 DT, TT, or aP containing Myocarditis Insufficient Weak (diphtheria toxoid) Lacking (tetanus toxoid or acellular pertussis) Inadequate
9 HPV Pancreatitis Insufficient Lacking Inadequate
4 MMR Hepatitis Insufficient Weak Inadequate
9 HPV Thromboembolic Events Insufficient Lacking Inadequate
5 Varicella Strokeb Limited Weak Inadequate
6 Influenza Stroke Moderate (decrease) Lacking Inadequate
9 HPV Hypercoagulable States Insufficient Lacking Inadequate
6 Influenza Myocardial Infarction Moderate (decrease) Weak (Live Attenuated Influenza Vaccine) Lacking (Inactivated Influenza Vaccine) Inadequate
4 MMR Chronic Fatigue Syndrome Insufficient Lacking Inadequate
11 Meningococcal Chronic Headache Insufficient Lacking Inadequate
4 MMR Fibromyalgia Insufficient Lacking Inadequate
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Chapter Vaccine Adverse Event Epidemiologic Assessment Mechanistic Assessment Causality Conclusion
6 Influenza Fibromyalgia Insufficient Lacking Inadequate
8 Hepatitis B Fibromyalgia Insufficient Lacking Inadequate
10 DT, TT, or aP containing Fibromyalgia Insufficient Lacking Inadequate
10 DT, TT, or aP containing Sudden Infant Death Syndrome Insufficient Lacking Inadequate
4 MMR Hearing Loss Insufficient Low-Intermediate (measles or mumps) Lacking (rubella) Inadequate
6 Influenza All-Cause Mortalityb Moderate {decrease) Weak (Live Attenuated Influenza Vaccine) Lacking (Inactivated Influenza Vaccine) Inadequate
6 Influenza Oculorespiratory Syndrome Moderate (increase)d Intermediated Favors Acceptanced
5 Varicella Thrombocytopenia Insufficient Weak Inadequate
10 DT, TT, or aP containing Immune Thrombocytopenic Purpura Insufficient Lacking Inadequate
12 Injection-Related Event Complex Regional Pain Syndrome Insufficient Low-Intermediate Inadequate
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
12 Injection-Related Event Deltoid Bursitis Limited Strong Convincingly Supports
12 Injection-Related Event Syncope Insufficient Strong Convincingly Supports

NOTE: The measles-mumps-rubella; human papillomavirus; and diphtheria toxoid–, tetanus toxoid-, and acellular pertussis-containing vaccines have been abbreviated in the following ways: MMR; HPV; and DT, TT, and aP containing.

   a The committee attributes causation to the measles component of the vaccine.

   b Although not originally charged to the committee by the sponsor, the committee considered this adverse event in its review of the literature.

   c The committee attributes causation to the rubella component of the vaccine.

   d The committee attributes causation to two particular vaccines used in three particular years in Canada.

Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×

TABLE D-3 Causality Conclusions Organized by Causality Conclusion, Adverse Event, and Chapter

Chapter Vaccine Adverse Event Epidemiologic Assessment Mechanistic Assessment Causality Conclusion
5 Varicella Disseminated Oka VZV without Other Organ Involvement Insufficient Strong Convincingly Supports
5 Varicella Disseminated Oka VZV with Subsequent Infection Resulting in Pneumonia, Meningitis, or Hepatitis Limited (subsequent infection resulting in pneumonia)
Insufficient (subsequent infection resulting in meningitis or hepatitis)
Strong (in individuals with demonstrated immunodeficiencies) Convincingly Supports (in individuals with demonstrated immunodeficiencies)
5 Varicella Vaccine Strain Viral Reactivation without Other Organ Involvement Insufficient Strong Convincingly Supports
5 Varicella Vaccine Strain Viral Reactivation with Subsequent Infection resulting in Meningitis or Encephalitis Limited (subsequent infection resulting in encephalitis) Insufficient (subsequent infection resulting in meningitis) Strong Convincingly Supports
4 MMR Measles Inclusion Body Encephalitis Insufficient Strong (measles; in individuals with demonstrated immunodehc iencies) Lacking (mumps or rubella) Convincingly Supportsa (in individuals with demonstrated immunodeficiencies)
4 MMR Febrile Seizures High (increase) Intermediate Convincingly Supports
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
4 MMR Anaphylaxis Insufficient Strong Convincingly Supports
5 Varicella Anaphylaxis Limited Strong Convincingly Supports
6 Influenza Anaphylaxis Limited Strong Convincingly Supports
8 Hepatitis B Anaphylaxis Insufficient Strong (in yeast-sensitive individuals) Convincingly Supports (in yeast-sensitive individuals)
10 TT containing Anaphylaxis Insufficient Strong Convincingly Supports
11 Meningococcal Anaphylaxis Insufficient Strong Convincingly Supports
12 Injection-Related Event Deltoid Bursitis Limited Strong Convincingly Supports
12 Injection-Related Event Syncope Insufficient Strong Convincingly Supports
9 HPV Anaphylaxis Insufficient Intermediate Favors Acceptance
4 MMR Transient Arthralgia in Women Moderate (increase) (rubella) Insufficient (measles or mumps) Intermediate (rubella) Lacking (measles or mumps) Favors Acceptanceb
4 MMR Transient Arthralgia in Children Moderate (increase) Weak (rubella) Lacking (measles or mumps) Favors Acceptance
6 Influenza Oculorespiratory Syndrome Moderate (increase)c Intermediatec Favors Acceptancec
4 MMR Autism High (null) Lacking Favors Rejection
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Chapter Vaccine Adverse Event Epidemiologic Assessment Mechanistic Assessment Causality Conclusion
6 Influenza Inactivated Influenza Vaccine and Bell’s Palsy High (null) Lacking Favors Rejection
6 Influenza Inactivated Influenza Vaccine and Asthma Exacerbation or Reactive Airway Disease Episodes in Children and Adults High (null) Weak Favors Rejection
4 MMR Type 1 Diabetes High (null) Lacking Favors Rejection
10 DT, TT, or aP containing Type 1 Diabetes High (null) Lacking Favors Rejection
4 MMR Encephalitis Limited Weak Inadequate
6 Influenza Encephalitis Insufficient Weak Inadequate
8 Hepatitis B Encephalitis Insufficient Lacking Inadequate
10 DT, TT, or aP containing Encephalitis Limited Weak Inadequate
11 Meningococcal Encephalitis Limited Lacking Inadequate
4 MMR Encephalopathy Limited Weak Inadequate
5 Varicella Encephalopathy Insufficient Lacking Inadequate
6 Influenza Encephalopathy Insufficient Weak Inadequate
8 Hepatitis B Encephalopathy Insufficient Lacking Inadequate
10 DT, TT, or aP containing Encephalopathy Limited Weak Inadequate
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
11 Meningococcal Encephalopathy Limited Lacking Inadequate
10 DT, TT, or aP containing Infantile Spasms Limited (diphtheria toxoid or tetanus toxoid) Insufficient (acellular pertussis) Lacking Inadequate
4 MMR Afebrile Seizures Limited Lacking Inadequate
5 Varicella Seizures Limited Weak Inadequate
6 Influenza Seizuresd Mjxlerate (null) Lacking Inadequate
8 Hepatitis B Seizures Limited Lacking Inadequate
10 DT, TT, or aP containing Seizures Limited Weak (acellular pertussis) Lacking (diphtheria toxoid or tetanus toxoid) Inadequate
4 MMR Meningitis Moderate (null) Weak (mumps) Lacking (measles or rubella) Inadequate
5 Varicella Cerebellar Ataxia Insufficient Weak Inadequate
4 MMR Ataxia Insufficient Weak (measles or mumps) Lacking (rubella) Inadequate
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Chapter Vaccine Adverse Event Epidemiologic Assessment Mechanistic Assessment Causality Conclusion
10 DT, TT, or aP containing Ataxia Insufficient Lacking Inadequate
10 DT, TT, or aP containing Autism Insufficient Lacking Inadequate
4 MMR Acute Disseminated Encephalomyelitis Insufficient Weak Inadequate
5 Varicella Acute Disseminated Encephalomyeliris Insufficient Weak Inadequate
6 Influenza Acute Disseminated Encephalomyelitis Insufficient Weak Inadequate
Hepatitis A Acute Disseminated Encephalomyeliris Insufficient Weak Inadequate
8 Hepatitis B Acute Disseminated Encephalomyeliris Insufficient Low-Intermediate Inadequate
9 HPV Acute Disseminated Encephalomyeliris Insufficient Lacking Inadequate
10 DT, TT, or aP containing Acute Disseminated Encephalomyeliris Insufficient Weak (tetanus toxoid) Lacking (diphtheria toxoid or acellular pertussis) Inadequate
11 Meningococcal Acute Disseminated Encephalomyeliris Insufficient Lacking Inadequate
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
4 MMR Transverse Myelitis Insufficient Weak Inadequate
5 Varicella Transverse Myelitis Insufficient Weak Inadequate
6 Influenza Transverse Myelitis Insufficient Weak Inadequate
Hepatitis A Transverse Myelitis Insufficient Weak Inadequate
8 Hepatitis B Transverse Myelitis Insufficient Weak Inadequate
9 HPV Transverse Myelitis Insufficient Lacking Inadequate
10 DT, TT, or aP containing Transverse Myelitis Insufficient Lacking Inadequate
11 Meningococcal Transverse Myelitis Insufficient Lacking Inadequate
4 MMR Optic Neuritisd Limited Weak Inadequate
6 Influenza Optic Neuritisd Limited Weak Inadequate
8 Hepatitis B Optic Neuritisd Limited Lacking Inadequate
10 DT, TT, or aP containing Optic Neuritisd Limited (diphtheria toxoid or tetanus toxoid) Insufficient (acellular pertussis) Lacking Inadequate
4 MMR Neuromyelitis Optirad Insufficient Weak (rubella) Lacking (measles or mumps) Inadequate
6 Influenza Neuromyelitis Optica Insufficient Lacking Inadequate
8 Hepatitis B Neuromyelitis Optica Insufficient Lacking Inadequate
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Chapter Vaccine Adverse Event Epidemiologic Assessment Mechanistic Assessment Causality Conclusion
9 HPV Neuromyelitis Optica Insufficient Lacking Inadequate
4 MMR Multiple Sclerosis Onset in Adults Limited Lacking Inadequate
6 Influenza Multiple Sclerosis Onset in Adults Limited Lacking Inadequate
8 Hepatitis B Multiple Sclerosis Onset in Adults Limited Lacking Inadequate
10 DT, TT, or aP containing Multiple Sclerosis Onset in Adults Limited (diphtheria toxoid or tetanus toxoid) Insufficient (acellular pertussis) Lacking Inadequate
4 MMR Multiple Sclerosis Onset in Children Limited Lacking Inadequate
8 Hepatitis B Multiple Sclerosis Onset in Children Limited Lacking Inadequate
6 Influenza Multiple Sclerosis Relapse in Adults Limited Lacking Inadequate
8 Hepatitis B Multiple Sclerosis Relapse in Adults Limited Lacking Inadequate
10 DT, TT, or aP containing Multiple Sclerosis Relapse in Adults Limited (tetanus toxoid) Insufficient (diphtheria toxoid or acellular pertussis) Lacking Inadequate
8 Hepatitis B Multiple Sclerosis Relapse in Children Limited Lacking Inadequate
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
10 DT, TT, or aP containing Multiple Sclerosis Relapse in Children Limited (diphtheria toxoid or tetanus toxoid) Insufficient (acellular pertussis) Lacking Inadequate
7 Hepatitis A Multiple Sclerosis Insufficient Lacking Inadequate
9 HPV Multiple Sclerosis Insufficient Lacking Inadequate
11 Meningococcal Multiple Sclerosis Insufficient Lacking Inadequate
8 Hepatitis B First Demy el ina ting Event in Adults Moderate (null) Low-Intermediate Inadequate
8 Hepatitis B First Demyelinating Event in Children Limited Lacking Inadequate
4 MMR Guillain-Barre syndrome Insufficient Weak Inadequate
5 Varicella Guillain-Barre syndrome Insufficient Weak Inadequate
6 Influenza Guillain-Barre syndrome Moderate (null) Weak Inadequate
7 Hepatitis A Insufficient Weak Inadequate
8 Hepatitis B Guillain-Barre syndrome Insufficient Lacking Inadequate
9 HPV Guillain-Barre syndrome Insufficient Lacking Inadequate
10 DT, TT, or aP containing Guillain-Barre syndrome Insufficient Lacking Inadequate
11 Meningococcal Guillain-Barre syndrome Limited Lacking Inadequate
4 MMR Chronic Inflammatory Disseminated Polyneuropathy Insufficient Lacking Inadequate
6 Influenza Chronic Inflammatory Disseminated Insufficient Weak Inadequate
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Chapter Vaccine Adverse Event Epidemiologic Assessment Mechanistic Assessment Causality Conclusion
7 Hepatitis A Chronic Inflammatory Disseminated Polyneuropathy Insufficient Lacking Inadequate
8 Hepatitis B Chronic Inflammatory Disseminated Polyneuropathy Insufficient Lacking Inadequate
9 HPV Chronic Inflammatory Disseminated Polyneuropathy Insufficient Lacking Inadequate
10 DT, TT, or aP containing Chronic Inflammatory Disseminated Polyneuropathy Insufficient Lacking Inadequate
11 Meningococcal Chronic Inflammatory Disseminated Polyneuropathy Insufficient Lacking Inadequate
4 MMR Opsoclonus Myoclonus Syndrome Insufficient Lacking Inadequate
10 DT, TT, or aP containing Opsoclonus Myoclonus Syndrome Insufficient Lacking Inadequate
7 Hepatitis A Bell’s Palsy Insufficient Lacking Inadequate
10 DT, TT, or aP containing Bell’s Palsy Limited (acellular pertussis) Insufficient (diphtheria toxoid or tetanus toxoid) Weak (diphtheria toxoid or tetanus toxoid) Lacking (acellular pertussis) Inadequate
4 MMR Brachial Neuritis Insufficient Lacking Inadequate
6 Influenza Brachial Neuritis Insufficient Lacking Inadequate
8 Hepatitis B Brachial Neuritis Insufficient Lacking Inadequate
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
9 HPV Brachial Neuritis Insufficient Lacking Inadequate
9 HPV Amyotrophic Lateral Sclerosis Insufficient Lacking Inadequate
5 Varicella Small Fiber Neuropathyd Insufficient Lacking Inadequate
6 Influenza Small Fiber Neuropathy Insufficient Lacking Inadequate
7 Hepatitis A Anaphylaxis Insufficient Weak Inadequate
10 DT and aP containing Anaphylaxis Insufficient Lacking Inadequate
10 DT, TT, or aP containing Chronic Urticaria Insufficient Lacking Inadequate
10 DT, TT, or aP containing Serum Sickness Insufficient Weak (diphtheria toxoid or tetanus toxoid) Lacking (acellular pertussis) Inadequate
6 Influenza Live Attenuated Influenza Vaccine or Asthma Exacerbation or Reactive Airway Disease Episodes in Children Younger Than 5 Years of Age Moderate (null) Weak Inadequate
6 Influenza Live Attenuated Influenza Vaccine or Asthma Exacerbation or Reactive Airway Disease Episodes in Persons 5 Years of Age or Older Moderate (null) Weak Inadequate
8 Hepatitis B Erythema Nodosumd Insufficient Weak Inadequate
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Chapter Vaccine Adverse Event Epidemiologic Assessment Mechanistic Assessment Causality Conclusion
6 Influenza Onset or Exacerbation of Systemic Lupus Erythematosus Limited (exacerbation) Insufficient (onset) Lacking Inadequate
8 Hepatitis B Onset or Exacerbation of Systemic Lupus Erythematosus Limited (onset) Insufficient (exacerbation) Weak Inadequate
6 Influenza Onset or Exacerbation of Vasculitis Limited (exacerbation) Insufficient (onset) Weak (exacerbation) Lacking (onset) Inadequate
8 Hepatitis B Onset or Exacerbation of Vasculitis Insufficient Low-Intermediate Inadequate
6 Influenza Polyarteritis Nodosa Insufficient Lacking Inadequate
8 Hepatitis B Onset or Exacerbation of Polyarteritis Nodosa Insufficient Weak Inadequate
8 Hepatitis B Onset or Exacerbation of Psoriatic Arthritis Insufficient Lacking Inadequate
8 Hepatitis B Onset or Exacerbation of Reactive Arthritis Insufficient Weak Inadequate
8 Hepatitis B Onset and Exacerbation of Rheumatoid Arthritis Limited (exacerbation) Insufficient (onset) Weak Inadequate
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
8 Hepatitis B Onset or Exacerbation of Juvenile Idiopathic Arthritis Insufficient Weak Inadequate
9 HPV Transient Arthralgia Limited Lacking Inadequate
4 MMR Chronic Arthralgia in Women Limited (rubella) Insufficient (measles or mumps) Low-Intermediate (rubella) Lacking (measles or mumps) Inadequate
4 MMR Chronic Arthritis in Women Limited (rubella) Insufficient (measles or mumps) Low-Intermediate (rubella) Lacking (measles or mumps) Inadequate
4 MMR Chronic Arthropathy in Children Insufficient Weak (rubella) Lacking (measles or mumps) Inadequate
4 MMR Arthropathy in Men Limited Weak (rubella) Lacking (measles or mumps) Inadequate
5 Varicella Onset or Exacerbation Arthropathy Insufficient Lacking Inadequate
6 Influenza Onset or Exacerbation of Arthropathy Insufficient Weak Inadequate
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Chapter Vaccine Adverse Event Epidemiologic Assessment Mechanistic Assessment Causality Conclusion
10 DT, TT, or aP containing Arthropathy Limited (diphtheria toxoid or tetanus toxoid) Insufficient (acellular pertussis) Lacking Inadequate
8 Hepatitis B Type 1 Diabetes Moderate (null) Lacking Inadequate
7 Hepatitis A Autoimmune Hepatitis Insufficient Weak Inadequate
10 DT, TT, or aP containing Myocarditis Insufficient Weak (diphtheria toxoid) Lacking (tetanus toxoid or acellular pertussis) Inadequate
9 HPV Pancreatitis Insufficient Lacking Inadequate
4 MMR Hepatitis Insufficient Weak Inadequate
9 HPV Thromboembolic Events Insufficient Lacking Inadequate
5 Varicella Stroked Limited Weak Inadequate
6 Influenza Stroke Moderate (decrease) Lacking Inadequate
9 HPV Hypercoagulable States Insufficient Lacking Inadequate
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
6 Influenza Myocardial Infarction Moderate (decrease) Weak (Live Attenuated influenza Vaccine) Lacking (Inactivated Influenza Vaccine) Inadequate
4 MMR Chronic Fatigue Syndrome Insufficient Lacking Inadequate
11 Meningococcal Chronic Headache Insufficient Lacking Inadequate
4 MMR Fibromyalgia Insufficient Lacking Inadequate
6 Influenza Fibromyalgia Insufficient Lacking Inadequate
8 Hepatitis B Fibromyalgia Insufficient Lacking Inadequate
10 DT, TT, or aP containing Fibromyalgia Insufficient Lacking Inadequate
10 DT, TT, or aP containing Sudden Infant Death Syndrome Insufficient Lacking Inadequate
4 MMR Hearing Loss Insufficient Low-Intermediate (measles or mumps) Lacking (rubella) Inadequate
6 Influenza All-Cause Mortalityd Moderate (decrease) Weak (Live Attenuated Influenza Vaccine) Lacking (Inactivated Influenza Vaccine) Inadequate
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Chapter Vaccine Adverse Event Epidemiologic Assessment Mechanistic Assessment Causality Conclusion
5 Varicella Thrombocytopenia Insufficient Weak Inadequate
10 DT, TT, or aP containing Immune Thrombocytopenic Purpura Insufficient Lacking Inadequate
12 Injection-Related Event Complex Regional Pain Syndrome Insufficient Low-Intermediate Inadequate

NOTE: The measles-mumps-rubella; human papillomavirus; and diphtheria toxoid–, tetanus toxoid-, and acellular pertussis-containing vaccines have been abbreviated in the following ways: MMR; HPV; and DT, TT, and aP containing.

   a The committee attributes causation to the measles component of the vaccine.

   b The committee attributes causation to the rubella component of the vaccine.

   a The committee attributes causation to two particular vaccines used in three particular years in Canada.

   a Although not originally charged to the committee by the sponsor, the committee considered this adverse event in its review of the literature.

Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×

TABLE D-4 Causality Conclusions Organized by Epidemiologic Assessment, Adverse Event, and Chapter

Chapter Vaccine Adverse Event Epidemiologic Assessment Mechanistic Assessment Causality Conclusion
4 MMR Febrile Seizures High (increase) Intermediate Convincingly Supports
4 MMR Autism High (null) Lacking Favors Rejection
6 Influenza Inactivated Influenza Vaccine and Bell’s Palsy High (null) Lacking Favors Rejection
6 Influenza Inactivated Influenza Vaccine and Asthma Exacerbation or Reactive Airway Disease Episodes in Children and Adults High (null) Weak Favors Rejection
4 MMR Type 1 Diabetes High (null) Lacking Favors Rejection
10 DT, TT, or aP containing Type 1 Diabetes High (null) Lacking Favors Rejection
4 MMR Transient Arthralgia in Women Moderate (increase) (rubella) Insufficient (measles or mumps) Intermediate (rubella) Lacking (measles or mumps) Favors Acceptancea
4 MMR Transient Arthralgia in Children Moderate (increase) Weak (rubella) Lacking (measles or mumps) Favors Acceptance
6 Influenza Oculorespiratory Syndrome Moderate (increase)b Intermediateb Favors Acceptanceb
6 Influenza Seizuresc Moderate (null) Lacking Inadequate
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Chapter Vaccine Adverse Event Epidemiologic Assessment Mechanistic Assessment Causality Conclusion
4 MMR Meningitisc Moderate (null) Weak (mumps) Lacking (measles or rubella) Inadequate
8 Hepatitis B First Dcmyclinating Event in Adults Moderate (null) Low-Intermediate Inadequate
6 Influenza Guillain-Barrc syndrome Moderate (null) Weak Inadequate
6 Influenza Live Attenuated Influenza Vaccine or Asthma Exacerbation or Reactive Airway Disease Episodes in Children Younger Than 5 Years of Age Moderate (null) Weak Inadequate
6 Influenza Live Attenuated Influenza Vaccine or Asthma Exacerbation or Reactive Airway Disease Episodes in Persons 5 Years of Age or Older Moderate (null) Weak Inadequate
8 Hepatitis B Type 1 Diabetes Moderate (null) Lacking Inadequate
6 Influenza Stroke Moderate (decrease) Lacking Inadequate
6 Influenza Myocardial Infarction Moderate (decrease) Weak (Live Attenuated Influenza Vaccine) Lacking (Inactivated Influenza Vaccine) Inadequate
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
6 Influenza All-Cause Mortalityc Moderate (decrease) Weak (Live Attenuated Influenza Vaccine) Lacking (Inactivated Influenza Vaccine) Inadequate
5 Varicella Disseminated Oka VZV with Subsequent Infection Resulting in Pneumonia, Meningitis, or Hepatitis Limited (subsequent infection resulting in pneumonia) Insufficient (subsequent infection resulting in meningitis or hepatitis) Strong (in individuals with demonstrated immunodeficiencies) Convincingly Supports (in individuals with demonstrated immunodeficiencies)
5 Varicella Vaccine Strain Viral Reactivation with Subsequent Infection Resulting in Meningitis or Encephalitis Limited (subsequent infection resulting in encephalitis) Insufficient (subsequent infection resulting in meningitis) Strong Convincingly Supports
4 MMR Encephalitis Limited Weak Inadequate
10 DT, TT, or aP containing Encephalitis Limited Weak Inadequate
11 Meningococcal Encephalitis Limited Lacking Inadequate
4 MMR Encephalopathy Limited Weak Inadequate
10 DT, TT, or aP containing Encephalopathy Limited Weak Inadequate
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Chapter Vaccine Adverse Event Epidemiologic Assessment Mechanistic Assessment Causality Conclusion
11 Meningococcal Encephalopathy Limited Lacking Inadequate
10 DT, TT, or aP containing Infantile Spasms Limited (diphtheria toxoid or tetanus toxoid) Insufficient
(accllular pertussis)
Lacking Inadequate
4 MMR Afebrile Seizures Limited Lacking Inadequate
5 Varicella Seizures Limited Weak Inadequate
8 Hepatitis B Seizures Limited Lacking Inadequate
10 DT, TT, or aP containing Seizures Limited Weak
(accllular pertussis) Lacking (diphtheria toxoid or tetanus toxoid)
Inadequate
4 MMR Optic Neuritisc Limited Weak Inadequate
6 Influenza Optic Neuritisc Limited Weak Inadequate
8 Hepatitis B Optic Neuritisc Limited Lacking Inadequate
10 DT, TT, or aP containing Optic Neuritisc Limited (diphtheria toxoid or tetanus toxoid) Insufficient (accllular pertussis) Lacking Inadequate
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
4 MMR Multiple Sclerosis Onset in Adults Limited Lacking Inadequate
6 Influenza Multiple Sclerosis Onset in Adults Limited Lacking Inadequate
8 Hepatitis B Multiple Sclerosis Onset in Adults Limited Lacking Inadequate
10 DT, TT, or aP containing Multiple Sclerosis Onset in Adults Limited
(diphtheria toxoid or tetanus toxoid)
Insufficient (accllular pertussis)
Lacking Inadequate
4 MMR Multiple Sclerosis Onset in Children Limited Lacking Inadequate
8 Hepatitis B Multiple Sclerosis Onset in Children Limited Lacking Inadequate
6 Influenza Multiple Sclerosis Relapse in Adults Limited Lacking Inadequate
8 Hepatitis B Multiple Sclerosis Relapse in Adults Limited Lacking Inadequate
10 DT, TT, or aP containing Multiple Sclerosis Relapse in Adults Limited (tetanus toxoid) Insufficient (diphtheria toxoid or accllular pertussis) Lacking Inadequate
8 Hepatitis B Multiple Sclerosis Relapse in Children Limited Lacking Inadequate
10 DT, TT, or aP containing Multiple Sclerosis Relapse in Children Limited (diphtheria toxoid or tetanus toxoid) Insufficient (accllular pertussis) Lacking Inadequate
8 Hepatitis B First Dcmyclinating Event in Children Limited Lacking Inadequate
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Chapter Vaccine Adverse Event Epidemiologic Assessment Mechanistic Assessment Causality Conclusion
11 Meningococcal Guillain-Barrc syndrome Limited Lacking Inadequate
10 DT, TT, or aP containing Bell’s Palsy Limited
(accllular pertussis) Insufficient (diphtheria toxoid or tetanus toxoid)
Weak
(diphtheria toxoid or tetanus toxoid) Lacking (accllular pertussis)
Inadequate
5 Varicella Anaphylaxis Limited Strong Convincingly Supports
6 Influenza Anaphylaxis Limited Strong Convincingly Supports
6 Influenza Onset or Exacerbation of Systemic Lupus Erythematosus Limited (exacerbation) Insufficient (onset) Lacking Inadequate
8 Hepatitis B Onset or Exacerbation of Systemic Lupus Erythematosus Limited (onset) Insufficient (exacerbation) Weak Inadequate
6 Influenza Onset or Exacerbation of Vasculitis Limited (exacerbation) Insufficient (onset) Weak (exacerbation) Lacking (onset) Inadequate
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
8 Hepatitis B Onset and Exacerbation of Rheumatoid Arthritis llll Weak Inadequate
9 HPV Transient Arthralgia Limited Lacking Inadequate
4 MMR Chronic Arthralgia in Women Limited (rubella) Insufficient (measles or mumps) Low-Intermediate (rubella) Lacking (measles or mumps) Inadequate
4 MMR Chronic Arthritis in Women Limited (rubella) Insufficient (measles or mumps) Low-Intermediate (rubella) Lacking (measles or mumps) Inadequate
4 MMR Arthropathy in Men Limited Weak (rubella) Lacking (measles or mumps) Inadequate
10 DT, TT, or aP containing Arthropathy Limited (diphtheria toxoid or tetanus toxoid) Insufficient (accllular pertussis) Lacking Inadequate
5 Varicella Strokec Limited Weak Inadequate
12 1 njection- Related Event Deltoid Bursitis Limited Strong Convincingly Supports
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Chapter Vaccine Adverse Event Epidemiologic Assessment Mechanistic Assessment Causality Conclusion
5 Varicella Disseminated Oka VZV without Other Organ Involvement Insufficient Strong Convincingly Supports
5 Varicella Vaccine Strain Viral Reactivation
without Other Organ Involvement
Insufficient Strong Convincingly Supports
4 MMR Measles Inclusion Body Encephalitis Insufficient Strong(measles; in with demon immunodef Lacking) Convincingly Supportsd
6 Influenza Encephalitis Insufficient Weak Inadequate
8 Hepatitis B Encephalitis Insufficient Lacking Inadequate
5 Varicella Encephalopathy Insufficient Lacking Inadequate
6 Influenza Encephalopathy Insufficient Weak Inadequate
8 Hepatitis B Encephalopathy Insufficient Lacking Inadequate
5 Varicella Cerebellar Ataxia Insufficient Weak Inadequate
4 MMR Ataxia Insufficient Weak (measles or i Lacking (rubella) Inadequate
10 DT, TT, or aP containing Ataxia Insufficient Lacking Inadequate
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
10 DT, TT, or aP containing Autism Insufficient Lacking Inadequate
4 MMR Acute Disseminated Encephalomyelitis Insufficient Weak Inadequate
5 Varicella Acute Disseminated Encephalomyelitis Insufficient Weak Inadequate
6 Influenza Acute Disseminated Encephalomyelitis Insufficient Weak Inadequate
7 Hepatitis A Acute Disseminated Encephalomyelitis Insufficient Weak Inadequate
8 Hepatitis B Acute Disseminated Encephalomyelitis Insufficient Low-Intermediate Inadequate
9 HPV Acute Disseminated Encephalomyelitis Insufficient Lacking Inadequate
10 DT, TT, or aP containing Acute Disseminated Encephalomyelitis Insufficient Weak
(tetanus toxoid) Lacking (diphtheria toxoid or acellular pertussis)
Inadequate
11 Meningococcal Acute Disseminated Encephalomyelitis Insufficient Lacking Inadequate
4 MMR Transverse Myelitis Insufficient Weak Inadequate
5 Varicella Transverse Myelitis Insufficient Weak Inadequate
6 Influenza Transverse Myelitis Insufficient Weak Inadequate
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Chapter Vaccine Adverse Event Epidemiologic Assessment Mechanistic Assessment Causality Conclusion
7 Hepatitis A Transverse Myelitis Insufficient Weak Inadequate
8 Hepatitis B Transverse Myelitis Insufficient Weak Inadequate
9 HPV Transverse Myelitis Insufficient Lacking Inadequate
10 DT, TT, or aP containing Transverse Myelitis Insufficient Lacking Inadequate
11 Meningococcal Transverse Myelitis Insufficient Lacking Inadequate
4 MMR Neuromyelitis Opticac Insufficient Weak
(rubella)
Lacking (measles or mumps)
Inadequate
6 Influenza Neuromyelitis Optica Insufficient Lacking Inadequate
8 Hepatitis B Neuromyelitis Optica Insufficient Lacking Inadequate
9 HPV Neuromyelitis Optica Insufficient Lacking Inadequate
Hepatitis A Multiple Sclerosis Insufficient Lacking Inadequate
9 HPV Multiple Sclerosis Insufficient Lacking Inadequate
11 Meningococcal Multiple Sclerosis Insufficient Lacking Inadequate
4 MMR Guillain-Barrc syndrome Insufficient Weak Inadequate
5 Varicella Guillain-Barrc syndrome Insufficient Weak Inadequate
7 Hepatitis A Guillain-Barrc syndrome Insufficient Weak Inadequate
8 Hepatitis B Guillain-Barrc syndrome Insufficient Lacking Inadequate
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
9 HPV Guillain-Barrc syndrome Insufficient Lacking Inadequate
10 DT, TT, or aP containing Guillain-Barrc syndrome Insufficient Lacking Inadequate
4 MMR Chronic Inflammatory Disseminated Polyneuropathy Insufficient Lacking Inadequate
6 Influenza Chronic Inflammatory Disseminated Polyneuropathy Insufficient Weak Inadequate
Hepatitis A Chronic Inflammatory Disseminated Polyneuropathy Insufficient Lacking Inadequate
8 Hepatitis B Chronic Inflammatory Disseminated Polyneuropathy Insufficient Lacking Inadequate
9 HPV Chronic Inflammatory Disseminated Polyneuropathy Insufficient Lacking Inadequate
10 DT, TT, or aP containing Chronic Inflammatory Disseminated Polyneuropathy Insufficient Lacking Inadequate
11 Meningococcal Chronic Inflammatory Disseminated Polyneuropathy Insufficient Lacking Inadequate
4 MMR Opsoclonus Myoclonus Syndrome Insufficient Lacking Inadequate
10 DT, TT, or aP containing Opsoclonus Myoclonus Syndrome Insufficient Lacking Inadequate
/ Hepatitis A Bell's Palsy Insufficient Lacking Inadequate
4 MMR Brachial Neuritis Insufficient Lacking Inadequate
6 Influenza Brachial Neuritis Insufficient Lacking Inadequate
8 Hepatitis B Brachial Neuritis Insufficient Lacking Inadequate
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Chapter Vaccine Adverse Event Epidemiologic Assessment Mechanistic Assessment Causality Conclusion
9 HPV Brachial Neuritis Insufficient Lacking Inadequate
9 HPV Amyotrophic Lateral Sclerosis Insufficient Lacking Inadequate
5 Varicella Small Fiber Ncuropathyc Insufficient Lacking Inadequate
6 Influenza Small Fiber Neuropathy Insufficient Lacking Inadequate
4 MMR Anaphylaxis Insufficient Strong Convincingly Supports
7 Hepatitis A Anaphylaxis Insufficient Weak Inadequate
8 Hepatitis B Anaphylaxis Insufficient Strong (in yeast-sensitive individuals) Convincingly Supports (in yeast-sensitive individuals)
9 HPV Anaphylaxis Insufficient Intermediate Favors Acceptance
10 TT containing Anaphylaxis Insufficient Strong Convincingly Supports
10 DT and aP containing Anaphylaxis Insufficient Lacking Inadequate
11 Meningococcal Anaphylaxis Insufficient Strong Convincingly Supports
10 DT, TT, or aP containing Chronic Urticaria Insufficient Lacking Inadequate
10 DT, TT, or aP containing Scrum Sickness Insufficient Weak
(diphtheria toxoid or tetanus toxoid)
Lacking (accllular pertussis)
Inadequate
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
8 Hepatitis B Erythema Nodosumc Insufficient Weak Inadequate
8 Hepatitis B Onset or Exacerbation of Vasculitis Insufficient Low-Intermediate Inadequate
6 Influenza Polyarteritis Nodosa Insufficient Lacking Inadequate
8 Hepatitis B Onset or Exacerbation of Polyarteritis Nodosa Insufficient Weak Inadequate
8 Hepatitis B Onset or Exacerbation of Psoriatic Arthritis Insufficient Lacking Inadequate
8 Hepatitis B Onset or Exacerbation of Reactive
Arthritis
Insufficient Weak Inadequate
8 Hepatitis B Onset or Exacerbation of Juvenile Idiopathic
Arthritis
Insufficient Weak Inadequate
4 MMR Chronic Arthropathy in Children Insufficient Weak (rubella) Lacking (measles or mumps) Inadequate
5 Varicella Onset or Exacerbation
Arthropathy
Insufficient Lacking Inadequate
6 Influenza Onset or Exacerbation of
Arthropathy
Insufficient Weak Inadequate
7 Hepatitis A Autoimmune Hepatitis Insufficient Weak Inadequate
10 DT, TT, or aP containing Myocarditis Insufficient Weak
(diphtheria toxoid) Lacking
(tetanus toxoid or accllular pertussis)
Inadequate
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Chapter Vaccine Adverse Event Epidemiologic Assessment Mechanistic Assessment Causality Conclusion
9 HPV Pancreatitis Insufficient Lacking Inadequate
4 MMR Hepatitis Insufficient Weak Inadequate
9 HPV Thromboembolic Events Insufficient Lacking Inadequate
9 HPV Hypcrcoagulablc States Insufficient Lacking Inadequate
4 MMR Chronic Fatigue Syndrome Insufficient Lacking Inadequate
11 Meningococcal Chronic Headache Insufficient Lacking Inadequate
4 MMR Fibromyalgia Insufficient Lacking Inadequate
6 Influenza Fibromyalgia Insufficient Lacking Inadequate
8 Hepatitis B Fibromyalgia Insufficient Lacking Inadequate
10 DT, TT, or aP
containing
Fibromyalgia Insufficient Lacking Inadequate
10 DT, TT, or aP
containing
Sudden Infant Death Syndrome Insufficient Lacking Inadequate
4 MMR Hearing Loss Insufficient Low-Intermediate
(measles or mumps) Lacking (rubella)
Inadequate
5 Varicella Thrombocytopenia Insufficient Weak Inadequate
10 DT, TT, or aP
containing
Immune Thrombocytopenic Purpura Insufficient Lacking Inadequate
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
12 Injcction- Related Event Complex Regional Pain Syndrome Insufficient Low-Intermediate Inadequate
12 Injcction- Related Event Syncope Insufficient Strong Convincingly Supports

NOTE: The measles-mumps-rubella; human papillomavirus; and diphtheria toxoid–, tetanus toxoid-, and acellular pertussis-containing vaccines have been abbreviated in the following ways: MMR; HPV; and DT, TT, and aP containing.

   aThe committee attributes causation to the rubella component of the vaccine.

   bThe committee attributes causation to two particular vaccines used in three particular years in Canada.

   cAlthough not originally charged to the committee by the sponsor, the committee considered this adverse event in its review of the literature.

   dThe committee attributes causation to the measles component of the vaccine.

Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×

TABLE D-5 Causality Conclusions Organized by Mechanistic Assessment, Adverse Event, and Chapter

Chapter Vaccine Adverse Event Epidemiologic
Assessment
Mechanistic
Assessment
Causality Conclusion
5 Varicella Disseminated Oka VZV without Other
Organ Involvement
Insufficient Strong Convincingly Supports
5 Varicella Disseminated Oka VZV with Subsequent Infection Resulting in Pneumonia, Meningitis, or Hepatitis Limited (subsequent infection resulting in pneumonia) Strong (in individuals with demonstrated immunodeficiencies) Convincingly Supports (in individuals with demonstrated immunodeficiencies)
5 Varicella Vaccine Strain Viral Reactivation without Other Organ Involvement Insufficient Strong Convincingly Supports
5 Varicella Vaccine Strain Viral Reactivation
with Subsequent Infection resulting
in Meningitis or Encephalitis
Limited (subsequent infection resulting in encephalitis) Insufficient (subsequent infection resulting in meningitis) Strong Convincingly Supports
4 MMR Measles Inclusion Body Encephalitis Insufficient Strong
(measles; in individuals with demonstrated immunodeficiencies) Lacking (mumps or rubella)
Convincingly Supportsa
(in individuals with demonstrated immunodeficiencies)
4 MMR Anaphylaxis Insufficient Strong Convincingly Supports
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
5 Varicella Anaphylaxis Limited Strong Convincingly Supports
6 Influenza Anaphylaxis Limited Strong Convincingly Supports
8 Hepatitis B Anaphylaxis Insufficient Strong (in yeast-sensitive individuals) Convincingly Supports (in yeast-sensitive individuals)
10 TT containing Anaphylaxis Insufficient Strong Convincingly Supports
11 Meningococcal Anaphylaxis Insufficient Strong Convincingly Supports
12 Injection- Related Event Deltoid Bursitis Limited Strong Convincingly Supports
12 Injection- Related Event Syncope Insufficient Strong Convincingly Supports
4 MMR Febrile Seizures High (increase) Intermediate Convincingly Supports
9 HPV Anaphylaxis Insufficient Intermediate Favors Acceptanceb
4 MMR Transient Arthralgia Moderate (increase)
(rubella)
Insufficient (measles or mumps)
Intermediate (rubella) Lacking (measles or mumps) Favors Acceptancec
6 Influenza Oculorespiratory Syndrome Moderate (increase) Intermediate Favors Acceptance'
8 Hepatitis B Acute Disseminated Encephalomyelitis Low-Intermediate Inadequate
8 Hepatitis B First Dcmyclinating Event in Adults Low-Intermediate Inadequate
8 Hepatitis B Onset or Exacerbation of Vasculitis Insufficient Low-Intermediate Inadequate
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Chapter Vaccine Adverse Event Epidemiologic Assessment Mechanistic Assessment Causality Conclusion
4 MMR Chronic Arthralgia in Women Limited
(rubella)
Insufficient
(measles or mumps)
Low-Intermediate
(rubella)
Lacking (measles or mumps)
Inadequate
4 MMR phronic Arthritis in Women Limited
(rubella) Insufficient
(measles or mumps)
Low-Intermediate
(rubella)
Lacking (measles or mumps)
Inadequate
4 MMR Hearing Loss Insufficient Low-Intermediate
(measles or mumps)
Lacking (rubella)
Inadequate
12 Injection- Related Event Complex Regional Pain Syndrome Insufficient Low-Intermediate Inadequate
4 MMR Encephalitis Limited Weak Inadequate
6 Influenza Encephalitis Insufficient Weak Inadequate
10 DT, TT, or aP containing Encephalitis Limited Weak Inadequate
4 MMR Encephalopathy Limited Weak Inadequate
6 Influenza Encephalopathy Insufficient Weak Inadequate
10 DT, TT, or aP containing Encephalopathy Limited Weak Inadequate
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
5 Varicella Seizures Limited Weak Inadequate
10 DT, TT, or aP containing Seizures Limited Weak
(accllular pertussis) Lacking
(diphtheria toxoid or tetanus toxoid)
Inadequate
4 MMR Meningitisd Moderate (null) Weak
(mumps) Lacking (measles or rubella)
Inadequate
5 Varicella Cerebellar Ataxia Insufficient Weak Inadequate
4 MMR Ataxia Insufficient Weak
(measles or mumps) Lacking (rubella)
Inadequate
4 MMR Acute Disseminated Encephalomyelitis Insufficient Weak Inadequate
5 Varicella Acute Disseminated Encephalomyelitis Insufficient Weak Inadequate
6 Influenza Acute Disseminated Encephalomyelitis Insufficient Weak Inadequate
7 Hepatitis A Acute Disseminated Encephalomyelitis Insufficient Weak Inadequate
10 DT, TT, or aP containing Acute Disseminated Encephalomyelitis Insufficient Weak
(tetanus toxoid) Lacking
(diphtheria toxoid or accllular pertussis)
Inadequate
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Chapter Vaccine Adverse Event Epidemiologic Assessment Mechanistic Assessment Causality Conclusion
4 MMR Transverse Myelitis Insufficient Weak Inadequate
5 Varicella Transverse Myelitis Insufficient Weak Inadequate
6 Influenza Transverse Myelitis Insufficient Weak Inadequate
7 Hepatitis A Transverse Myelitis Insufficient Weak Inadequate
8 Hepatitis B Transverse Myelitis Insufficient Weak Inadequate
4 MMR Optic Neuritis1d Limited Weak Inadequate
6 Influenza Optic Neuritisd Limited Weak Inadequate
4 MMR Neuromyelitis Opticad Insufficient Weak
(rubella) Lacking
(measles or mumps)
Inadequate
4 MMR Guillain-Barrc syndrome Insufficient Weak Inadequate
5 Varicella Guillain-Barrc syndrome Insufficient Weak Inadequate
6 Influenza Guillain-Barrc syndrome Moderate (null) Weak Inadequate
7 Hepatitis A Guillain-Barrc syndrome Insufficient Weak Inadequate
6 Influenza Chronic Inflammatory Disseminated
Polyneuropathy
Insufficient Weak Inadequate
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
10 DT, TT, or aP containing Bell’s Palsy Limited
(accllular pertussis) Insufficient
(diphtheria toxoid or tetanus toxoid)
Weak
(diphtheria toxoid or tetanus toxoid) Lacking
(accllular pertussis)
Inadequate
7 Hepatitis A Anaphylaxis Insufficient Weak Inadequate
10 DT, TT, or aP containing Scrum Sickness Insufficient Weak
(diphtheria toxoid or tetanus toxoid) Lacking
(accllular pertussis)
Inadequate
6 Influenza Inactivated Influenza Vaccine and
Asthma Exacerbation or Reactive
Airway Disease Episodes in Children
and Adults
High (null) Weak Favors Rejection
6 Influenza Live Attenuated Influenza Vaccine
or Asthma Exacerbation or Reactive
Airway Disease Episodes in Children Younger Than 5 Years of Age
Moderate (null) Weak Inadequate
6 Influenza Live Attenuated Influenza Vaccine
or Asthma Exacerbation or Reactive
Airway Disease Episodes in Persons 5
Years of Age or Older
Moderate (null) Weak Inadequate
8 Hepatitis B Erythema Nodosumd Insufficient Weak Inadequate
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Chapter Vaccine Adverse Event Epidemiologic Assessment Mechanistic Assessment Causality Conclusion
8 Hepatitis B Onset or Exacerbation of Systemic Lupus Erythematosus Limited (onset) Insufficient (exacerbation) Weak Inadequate
6 Influenza Onset or Exacerbation of Vasculitis Limited (exacerbation) Insufficient (onset) Weak (exacerbation) Lacking (onset) Inadequate
8 Hepatitis B Onset or Exacerbation of Polyarteritis
Nodosa
Insufficient Weak Inadequate
8 Hepatitis B Onset or Exacerbation of Reactive
Arthritis
Insufficient Weak Inadequate
8 Hepatitis B Onset and Exacerbation of Rheumatoid Arthritis Limited (exacerbation) Insufficient (onset) Weak Inadequate
8 Hepatitis B Onset or Exacerbation of Juvenile
Idiopathic Arthritis
Insufficient Weak Inadequate
4 MMR Transient Arthralgia in Children Moderate (increase) Weak
(rubella) Lacking
(measles or mumps)
Favors Acceptance
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
4 MMR Chronic Arthropathy in Children Insufficient Weak
(rubella) Lacking
(measles or mumps)
Inadequate
4 MMR Arthropathy in Men Limited Weak
(rubella) Lacking
(measles or mumps)
Inadequate
6 Influenza Onset or Exacerbation of Arthropathy Insufficient Weak Inadequate
7 Hepatitis A Autoimmune Hepatitis Insufficient Weak Inadequate
10 DT, TT, or aP containing Myocarditis Insufficient Weak
(diphtheria toxoid) Lacking
(tetanus toxoid or acellular pertussis)
Inadequate
4 MMR Hepatitis Insufficient Weak Inadequate
5 Varicella Stroked Limited Weak Inadequate
6 Influenza Myocardial Infarction Moderate (decrease) Weak
(Live Attenuated Influenza Vaccine) Lacking
(Inactivated Influenza Vaccine)
Inadequate
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Chapter Vaccine Adverse Event Epidemiologic Assessment Mechanistic Assessment Causality Conclusion
6 Influenza All-Cause Mortalityd Moderate (decrease) Weak
(Live Attenuated Influenza Vaccine) Lacking
(Inactivated Influenza Vaccine)
Inadequate
5 Varicella Thrombocytopenia Insufficient Weak Inadequate
8 Hepatitis B Encephalitis Insufficient Lacking Inadequate
11 Meningococcal Encephalitis Limited Lacking Inadequate
5 Varicella Encephalopathy Insufficient Lacking Inadequate
8 Hepatitis B Encephalopathy Insufficient Lacking Inadequate
11 Meningococcal Encephalopathy Limited Lacking Inadequate
10 DT, TT, or aP containing Infantile Spasms Limited
(diphtheria toxoid or tetanus toxoid) Insufficient
(accllular pertussis)
Lacking Inadequate
4 MMR Afebrile Seizures Limited Lacking Inadequate
6 Influenza Seizuresd Moderate (null) Lacking Inadequate
8 Hepatitis B Seizures Limited Lacking Inadequate
10 DT, TT, or aP containing Ataxia Insufficient Lacking Inadequate
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
4 MMR Autism High (null) Lacking Favors Rejection
10 DT, TT, or aP containing Autism Insufficient Lacking Inadequate
9 HPV Acute Disseminated Encephalomyelitis Insufficient Lacking Inadequate
11 Meningococcal Acute Disseminated Encephalomyelitis Insufficient Lacking Inadequate
9 HPV Transverse Myelitis Insufficient Lacking Inadequate
10 DT, TT, or aP
containing
Transverse Myelitis Insufficient Lacking Inadequate
11 Meningococcal Transverse Myelitis Insufficient Lacking Inadequate
8 Hepatitis B Optic Neuritisd Limited Lacking Inadequate
10 DT, TT, or aP
containing
Optic Neuritisd Limited
(diphtheria toxoid or tetanus toxoid) Insufficient
(accllular pertussis)
Lacking Inadequate
6 Influenza Neuromyelitis Optica Insufficient Lacking Inadequate
8 Hepatitis B Neuromyelitis Optica Insufficient Lacking Inadequate
9 HPV Neuromyelitis Optica Insufficient Lacking Inadequate
4 MMR Multiple Sclerosis Onset in Adults Lacking Limited Inadequate
6 Influenza Multiple Sclerosis Onset in Adults Limited Lacking Inadequate
8 Hepatitis B Multiple Sclerosis Onset in Adults Lacking Limited Lacking
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Chapter Vaccine Adverse Event Epidemiologic Assessment Mechanistic Assessment Causality Conclusion
10 DT, TT, or aP containing Multiple Sclerosis Onset in Adults Limited
(diphtheria toxoid or tetanus toxoid) Insufficient
(accllular pertussis)
Lacking Inadequate
4 MMR Multiple Sclerosis Onset in Children Limited Lacking Inadequate
8 Hepatitis B Multiple Sclerosis Onset in Children Limited Lacking Inadequate
6 Influenza Multiple Sclerosis Relapse in Adults Limited Lacking Inadequate
8 Hepatitis B Multiple Sclerosis Relapse in Adults Limited Lacking Inadequate
10 DT, TT, or aP containing Multiple Sclerosis Relapse in Adults Limited
(tetanus toxoid) Insufficient
(diphtheria toxoid or accllular pertussis)
Lacking Inadequate
8 Hepatitis B Multiple Sclerosis Relapse in Children Limited Lacking Inadequate
10 DT, TT, or aP containing Multiple Sclerosis Relapse in Children Limited
(diphtheria toxoid or tetanus toxoid) Insufficient
(accllular pertussis)
Lacking Inadequate
7 Hepatitis A Multiple Sclerosis Insufficient Lacking Inadequate
9 HPV Multiple Sclerosis Insufficient Lacking Inadequate
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
11 Meningococcal Multiple Sclerosis Insufficient Lacking Inadequate
8 Hepatitis B First Dcmyclinating Event in Children Limited Lacking Inadequate
8 Hepatitis B Guillain-Barrc syndrome Insufficient Lacking Inadequate
9 HPV Guillain-Barrc syndrome Insufficient Lacking Inadequate
10 DT, TT, or aP containing Guillain-Barrc syndrome Insufficient Lacking Inadequate
11 Meningococcal Guillain-Barrc syndrome Limited Lacking Inadequate
4 MMR Chronic Inflammatory Disseminated
Polyneuropathy
Insufficient Lacking Inadequate
7 Hepatitis A Chronic Inflammatory Disseminated
Polyneuropathy
Insufficient Lacking Inadequate
8 Hepatitis B Chronic Inflammatory Disseminated
Polyneuropathy
Insufficient Lacking Inadequate
9 HPV Chronic Inflammatory Disseminated
Polyneuropathy
Insufficient Lacking Inadequate
10 DT, TT, or aP containing Chronic Inflammatory Disseminated
Polyneuropathy
Insufficient Lacking Inadequate
11 Meningococcal Chronic Inflammatory Disseminated
Polyneuropathy
Insufficient Lacking Inadequate
4 MMR Opsoclonus Myoclonus Syndrome Insufficient Lacking Inadequate
10 DT, TT, or aP containing Opsoclonus Myoclonus Syndrome Insufficient Lacking Inadequate
6 Influenza Inactivated Influenza Vaccine and Bell’s Palsy High (null) Lacking Favors Rejection
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Chapter Vaccine Adverse Event Epidemiologic Assessment Mechanistic Assessment Causality Conclusion
7 Hepatitis A Bell’s Palsy Insufficient Lacking Inadequate
4 MMR Brachial Neuritis Insufficient Lacking Inadequate
6 Influenza Brachial Neuritis Insufficient Lacking Inadequate
8 Hepatitis B Brachial Neuritis Insufficient Lacking Inadequate
9 HPV Brachial Neuritis Insufficient Lacking Inadequate
9 HPV Amyotrophic Lateral Sclerosis Insufficient Lacking Inadequate
5 Varicella Small Fiber Neuropathyd Insufficient Lacking Inadequate
6 Influenza Small Fiber Neuropathy Insufficient Lacking Inadequate
10 DT and aP containing Anaphylaxis Insufficient Lacking Inadequate
10 DT, TT, or aP containing Chronic Urticaria Insufficient Lacking Inadequate
6 Influenza Onset or Exacerbation of Systemic
Lupus Erythematosus
Limited (exacerbation) Insufficient (onset) Lacking Inadequate
6 Influenza Polyarteritis Nodosa Insufficient Lacking Inadequate
8 Hepatitis B Onset or Exacerbation
of Psoriatic Arthritis
Insufficient Lacking Inadequate
9 HPV Transient Arthralgia Limited Lacking Inadequate
5 Varicella Onset or Exacerbation Arthropathy Insufficient Lacking Inadequate
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
l0 DT, TT, or aP containing Arthropathy Limited (diphtheria toxoid or tetanus toxoid) Insufficient (accllular pertussis) Lacking Inadequate
4 MMR Type 1 Diabetes High (null) Lacking Favors Rejection
8 Hepatitis B Type 1 Diabetes Moderate (null) Lacking Inadequate
10 DT, TT, or aP containing Type 1 Diabetes High (null) Lacking Favors Rejection
9 HPV Pancreatitis Insufficient Lacking Inadequate
9 HPV Thromboembolic Events Insufficient Lacking Inadequate
6 Influenza Stroke Moderate (decrease) Lacking Inadequate
9 HPV Hypcrcoagulablc States Insufficient Lacking Inadequate
4 MMR Chronic Fatigue Syndrome Insufficient Lacking Inadequate
11 Meningococcal Chronic Headache Insufficient Lacking Inadequate
4 MMR Fibromyalgia Insufficient Lacking Inadequate
6 Influenza Fibromyalgia Insufficient Lacking Inadequate
8 Hepatitis B Fibromyalgia Insufficient Lacking Inadequate
10 DT, TT, or aP containing Fibromyalgia Insufficient Lacking Inadequate
10 DT, TT, or aP containing Sudden Infant Death Syndrome Insufficient Lacking Inadequate
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Chapter Vaccine Adverse Event Epidemiologic Assessment Mechanistic Assessment Causality Conclusion
10 DT, TT, or aP containing Immune Thrombocytopenic Purpura Insufficient Lacking Inadequate

NOTE: The measles-mumps-rubella; human papillomavirus; and diphtheria toxoid–, tetanus toxoid-, and acellular pertussis-containing vaccines have been abbreviated in the following ways: MMR; HPV; and DT, TT, and aP containing.

   aThe committee attributes causation to the measles component of the vaccine.

   bThe committee attributes causation to the rubella component of the vaccine.

   cThe committee attributes causation to two particular vaccines used in three particular years in Canada.

   dAlthough not originally charged to the committee by the sponsor, the committee considered this adverse event in its review of the literature.

Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Page 673
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Page 674
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Page 675
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Page 676
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Page 677
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Page 678
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Page 679
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Page 680
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Page 681
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Page 682
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Page 683
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Page 684
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Page 685
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Page 686
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Page 687
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Page 688
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Page 689
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Page 690
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Page 691
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Page 692
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Page 693
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Page 694
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Page 695
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Page 696
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Page 697
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Page 698
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Page 699
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Page 700
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Page 701
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Page 702
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Page 703
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Page 704
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Page 705
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Page 706
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Page 707
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Page 708
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Page 709
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Page 710
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Page 711
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Page 712
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Page 713
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Page 714
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Page 715
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Page 716
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Page 717
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Page 718
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Page 719
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Page 720
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Page 721
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Page 722
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Page 723
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Page 724
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Page 725
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Page 726
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Page 727
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Page 728
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Page 729
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Page 730
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Page 731
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Page 732
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Page 733
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Page 734
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Page 735
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Page 736
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Page 737
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Page 738
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Page 739
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Page 740
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Page 741
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Page 742
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Page 743
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Page 744
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Page 745
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Page 746
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Page 747
Suggested Citation:"Appendix D: Causality Conclusion Tables." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×
Page 748
Next: Appendix E: References »
Adverse Effects of Vaccines: Evidence and Causality Get This Book
×
Buy Hardback | $90.00 Buy Ebook | $69.99
MyNAP members save 10% online.
Login or Register to save!
Download Free PDF

In 1900, for every 1,000 babies born in the United States, 100 would die before their first birthday, often due to infectious diseases. Today, vaccines exist for many viral and bacterial diseases. The National Childhood Vaccine Injury Act, passed in 1986, was intended to bolster vaccine research and development through the federal coordination of vaccine initiatives and to provide relief to vaccine manufacturers facing financial burdens. The legislation also intended to address concerns about the safety of vaccines by instituting a compensation program, setting up a passive surveillance system for vaccine adverse events, and by providing information to consumers. A key component of the legislation required the U.S. Department of Health and Human Services to collaborate with the Institute of Medicine to assess concerns about the safety of vaccines and potential adverse events, especially in children.

Adverse Effects of Vaccines reviews the epidemiological, clinical, and biological evidence regarding adverse health events associated with specific vaccines covered by the National Vaccine Injury Compensation Program (VICP), including the varicella zoster vaccine, influenza vaccines, the hepatitis B vaccine, and the human papillomavirus vaccine, among others. For each possible adverse event, the report reviews peer-reviewed primary studies, summarizes their findings, and evaluates the epidemiological, clinical, and biological evidence. It finds that while no vaccine is 100 percent safe, very few adverse events are shown to be caused by vaccines. In addition, the evidence shows that vaccines do not cause several conditions. For example, the MMR vaccine is not associated with autism or childhood diabetes. Also, the DTaP vaccine is not associated with diabetes and the influenza vaccine given as a shot does not exacerbate asthma.

Adverse Effects of Vaccines will be of special interest to the National Vaccine Program Office, the VICP, the Centers for Disease Control and Prevention, vaccine safety researchers and manufacturers, parents, caregivers, and health professionals in the private and public sectors.

  1. ×

    Welcome to OpenBook!

    You're looking at OpenBook, NAP.edu's online reading room since 1999. Based on feedback from you, our users, we've made some improvements that make it easier than ever to read thousands of publications on our website.

    Do you want to take a quick tour of the OpenBook's features?

    No Thanks Take a Tour »
  2. ×

    Show this book's table of contents, where you can jump to any chapter by name.

    « Back Next »
  3. ×

    ...or use these buttons to go back to the previous chapter or skip to the next one.

    « Back Next »
  4. ×

    Jump up to the previous page or down to the next one. Also, you can type in a page number and press Enter to go directly to that page in the book.

    « Back Next »
  5. ×

    Switch between the Original Pages, where you can read the report as it appeared in print, and Text Pages for the web version, where you can highlight and search the text.

    « Back Next »
  6. ×

    To search the entire text of this book, type in your search term here and press Enter.

    « Back Next »
  7. ×

    Share a link to this book page on your preferred social network or via email.

    « Back Next »
  8. ×

    View our suggested citation for this chapter.

    « Back Next »
  9. ×

    Ready to take your reading offline? Click here to buy this book in print or download it as a free PDF, if available.

    « Back Next »
Stay Connected!