One patient, receiving systemic FL as a vaccine adjuvant, developed clinical evidence of autoimmune disease.

Sequential anti-SSA (□), dsDNA (○), and ANA (▵) are shown in one patient plotted over time. This patient received FL and GM-CSF as a vaccine adjuvant. Large arrows at the top of graph indicate the development of nonspecific symptoms (Sx) of dry eyes, diagnosis of Sicca syndrome (Sicca), and resolution of symptoms (No Sx).