Information has been received from a nurse practitioner concerning a 25 month old white male who is in good health who on 6/18/02 was vaccinated with a dose of varicella virus vaccine live (lot # 637978/0562L). There was no illness at the time of vaccination. It was reported that the child was taking a multivita-bets/fluoride/iron chew at the time of vaccination. There was no chronic medications, but it is unknown if other vaccinations were given on the same date. On 7/25/03 it was reported that the child developed a severe case of chickenpox. The rash developed about a week ago, on approximately 7/18/03, and was believed to be poison ivy and was treated with diphenhydramine hydrochloride cream. There had been no fever over the past week. When the child was seen in the physician's office on 7/25/03, his legs from the knee down were covered with lesions at every stage. There were also lesions of varying stages on the trunk (more around the waist line), upper legs, arms, face, scalp, and even a few inside the mouth. The child did not have a fever, his chest was clear, he was not toxic, and he was well hydrated. The nurse practitioner estimated over 100 lesions overall. The mother could not recall exposure, but felt that there may have been an unidentified exposure during a 4th of July picnic. The child is itchy, but otherwise fine. The child is due back to the physician's office on 7/28/03. the child was prescribed cetirizine hydrochloride for the itching and amoxicillin (+) clavulanate potassium to prevent superinfection. There was no product quality complaint. Follow up information received from a nurse practitioner indicated that initially the patient was diagnosed with varicella, but viral cultures were negative. When no improvement, the patient was recultured and the cultures were positive for staph aureus. The child was subsequently diagnosed with severe bullous impetigo and was prescribed IM and PO antibiotics. The outcome was reported as recovered. It was noted that on 8/19/03 there was a large improvement. Follow up information received from a medical record indicated that the patient presented to the physician's office on 7/28/03 with his mother for a rash all over his body for 1 week. There was no pain associated with the visit. The mother stated that the rash began on the stomach one week ago and has spread from his scalp to his legs. The rash was getting worse on the legs and was treating her son with diphenhydramine hydrochloride lotion after speaking on the phone with the physician. The mother stated that she and the father are very sensitive to poison ivy but neither of them got poison and was in the same place as the child. There are no other family members with any type of rash. The child was at a picnic on 7/4/03 and was exposed to many people, none of whom were ill to her knowledge. She denies any fever, cough, painful sores, or drainage from the rash. It was noted that the child had become more cranky within the past week. His fluids and sleep were disturbed secondary to the itching. The rash was described as a combination of pink papules, pink papules with vesicles, and papules with scabs. There were mainly pink papules on his scalp, face, and arms. The lower trunk had a combination rash and the lower legs were covered with larger papules, vesicles, and scabs. There was positive excoriation; no yellow crusting of lesions, black lesions or drainage of lesions. It was also noted that: PEARL; n/t pharynx with several white papules and vesicles on buccal mucosa; lungs clear; abdomen soft and non-tender; neuro-normal. The plan of treatment consisted of amoxicillin (+) clavulanate potassium and cetirizine hydrochloride. Literature was given and reviewed for supportive care and they were instricted to keep cool, trim nails, and Aveeno baths. On 7/25/03, lab data showed no varicella zoster virus antigen detected, no herpes simplex virus - type I antigen detected, no herpes simplex virus - type II antigen detected, and no virus isolated. On 8/12/03, the patient presented to the physician's office for a follow up visit. There was no pain associated with this visit, and it was noted that the child has had varicella and still had quite a few vesicles and is up all night itching. The rash was noted to be worse with more pussy lesions, oozing, some pussy eyes, no fever, and itching. The nurse's notes on the exam appeared to be normal. The child was diagnosed with impetigo and pyoderma. The plan of treatment was to begin medications: hydroxyzine hydrochloride, cephalexin, polymyxin B sulfate (+) trimethoprim, mupirocin. At this time, a routine culture was drawn which showed moderate staphylococcus aureus and moderate growth normal skin flora. Upon internal review, severe bullous impetigo was considered to be an other important medical event (OMIC). No further information is expected.