Table 2 Suggested criteria for the diagnosis of autoimmune/inflammatory syndrome induced by adjuvants [9]

Major criteria

• Exposure to an external stimulus (infection, vaccine, silicone, adjuvant) prior to clinical manifestations

• The appearance of ‘typical’ clinical manifestations:

  Myalgia, myositis, or muscle weakness

  Arthralgia and/or arthritis

  Chronic fatigue, un-refreshing sleep, or sleep disturbances

  Neurological manifestations (especially associated with demyelination)

  Cognitive impairment, memory loss

  Pyrexia, dry mouth

• Removal of inciting agent induces improvement

• Typical biopsy of involved organs

Minor criteria

• The appearance of autoantibodies or antibodies directed at the suspected adjuvant

• Other clinical manifestations (e.g., irritable bowel syndrome)

• Specific HLA (e.g., HLA DRB1…, HLA DQB1…)

• Evolvement of an autoimmune disease (e.g., multiple sclerosis, systemic sclerosis)