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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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.
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) |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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.
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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.
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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.
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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.