In most patients, the toxicity was limited to the reaction at the vaccine injection site. All patients developed pruritic papules that progressed to pustules, sometimes with small ulcerations, that resolved into small white or pink scars. The intensity of the local reactions was ameliorated by reducing the dose of bacille Calmette-Guérin (BCG). As expected, about one-third of patients developed nausea, sometimes with vomiting, following administration of cyclophosphamide, but systemic toxicity caused by the vaccine was uncommon: Less than 5% of patients noted fever or chills following vaccine administration, and no patient experienced a decrease in performance status. One patient developed generalized urticaria 15 min after injection of her fourth dose of DNP-vaccine; this was treated with an antihistamime and resolved in 5 d without sequelae. Three patients developed erythema around their lymphadenectomy sites following vaccine administration, which was asymptomatic and spontaneously abated. Skin biopsy of one of these patients showed a nonspecific vasculitis. There were no significant changes in blood counts or routine serum chemistries. We observed no clinical evidence of autoimmunity. Specifically, no patients developed vitiligo following treatment.
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