Table 3.

Criteria for ASIA [from Shoenfeld and Agmon-Levin (42)].

Major criteria

Exposure to an external stimuli (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 (i.e., irritable bowel syn.)

Specific HLA (i.e., HLA DRB1, HLA DQB1)

Evolvement of an autoimmune disease (i.e., MS, SSc)