Clinical, laboratory, and pathologic findings in nine of the 12 patients who died from toxic shock syndrome in Minnesota are reported. All patients met the toxic shock syndrome case definition except for desquamation, which occurred in only one patient. Eight were menstruating and at least four were wearing tampons at the time of the acute illness. One patient was using napkins only. Noncardiogenic pulmonary edema was the only clinical development that could be used to predict a fatal outcome. Specific pathologic findings included various degrees of fatty metamorphosis of the liver; pronounced hemophagocytosis by reticuloendothelial macrophages; and a characteristic vaginal lesion consisting of mucosal separation beneath the basal layer with ulceration, severe vasodilatation, inflammation and thrombosis, but with minimal bacterial invasion. This vaginal lesion was noted in two tampon users, but an identical lesion was found in a menstruating patient who used only napkins.