Report A0372988A describes a hypersensitivity reaction in a 3 month old male who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed (Infanrix). Concurrent conditions included otitis media. Concurrent medications included amoxicillin for otitis media. The vaccinee had no adverse experiences following receipt of prior immunizations. On 10/29/01, the vaccinee received his first injection of Infanrix in his right leg. On the same date, he also received his first injection of combination Haemophilus influenzae type B conjugate/hepatitis B vaccine and his first injection of inactivated poliomyelitis virus vaccine. On 11/12/01, the vaccinee developed an abscess on his leg at the site of the Infanrix injection. He was seen by a physician at which time the abscess was cultured and determined to be a sterile abscess. The vaccinee was then referred to a dermatologist and suspected to have been allergic to the aluminum component of the vaccine. On 1/7/02, the subject received his second injection of Infanrix, his second injection of combination Haemophilus influenzae type B conjugate/hepatitis B vaccine, his second injection of inactivated poliomyelitis virus vaccine, and his first injection of 7-valent pneumococcal conjugate vaccine. On 1/22/02, a wound culture/smear of an abscess of the left thigh was obtained. Gram stain noted rare white blood cells with no organisms seen. Culture results showed no growth after two days. On 3/19/02, the subject was seen by the local dermatologist for evaluation of palpable nodular change sin the soft tissue of the thighs bilaterally where the subject received immunizations. The dermatologist and his colleague felt these areas represented sterile SC abscesses consistent with either foreign body granulomas or possibly SC fat necrosis. The dermatologist consulted with another physician who he felt had more experience with this type of lesion and reported that the best treatment for this type of condition is observation rather than any type of surgical intervention. The mother chose to pursue further treatment. On 3/27/02, the patient was seen by a pediatrician for evaluation of the nodules on his legs. On exam, the pediatrician noted a one cm circular scar on the left upper thigh which is the result of incision and drainage that the subject had several months ago. On the right upper thigh, there are three SC firm mobile nodules. The largest is two cm. The skin overlying this nodule is ecchymotic. There is a one cm nodule that has a more brownish overlying skin and then there is a half cm nodule which does not have any skin change overlying it. The pediatrician's impression and diagnoses was SC nodules of unknown etiology. The pediatrician did not feel this was an infectious process. The patient was referred to a dermatologist for further evaluation and/or biopsy of these nodules. On approximately 4/8/02, the subject was taken to the ER because one of the lesions drained green fluid. He was places on unspecified antibiotic. There was no further drainage. Additionally, paracetamol with codeine was prescribed for pain. Immunizations are not up to date secondary to some concern that they may have been related to these lesions. Mother notes that the immunizations he did receive were not given this high in the thigh region. There are no other skin concerns. There have been no fevers. On 4/10/02, a 4mm punch biopsy was performed lateral to the epidermal change of the right upper thigh SC nodule, directly over the nodule area. The biopsy revealed septal lymphohistiocytic infiltrate with admised eosinophils. On 5/2/02, the patient was seen by the physician for a follow up of SC nodules of the right thigh. The 4mm punch biopsy was non-diagnostic. It did show evidence of panniculitis with septal lymphohistiocytic infiltrate with admixed eosinophils. Since his visit, mother noted a nodule of the right lateral thigh has become more visible and has actually drained fluid intermittently. The patient continued on Tylenol with codeine to keep him comfortable since these are painful with palpitation. He is otherwise growing and is eating and drinking without difficulty. She denied that he had any fevers. There were no other skin concerns. On physical exam, there are three SC nodules palpable on the right upper thigh. Two of these have minimal epidermal change, are slightly raised and hyperpigmented. The proximal lateral lesion seems to be bigger than on previous examination and the epidermal change is new from previous examination. No drainage present. On 5/13/02, the subject underwent an excisional biopsy of some nodular masses in the right thigh region. These were small abscess cavities with chronic granulation infected tissue around them. The pediatric surgeon left drains in the wounds to be removed on follow up. The night of the surgery, apparently the child had vomiting, was taken to the hospital, and had an IV line placed following this. Apparently, the child did not vomit in the hospital. Then the child was readmitted for fevers. On 5/16/02, the child's incisions looked clean, dry, and intact. There was a little bit of drainage from one of the drains that is still in, and I removed this drain. I do not have a diagnosis for this child. The surgical pathology examination diagnosis was: A. Soft tissue, right thigh, biopsy: granulomas with acute and chronic inflammation, B. Skin, right thigh, biopsy: granulomas with acute and chronic inflammation. Comment: The underlying etiology of this granulomatous infiltrate is uncertain; however, an infectious process is favored. The 5/14/02 cultures revealed no acid fast bacilli, small amount growth Staphylococcus Warneri, small amount growth Enterococcus faecalis, small amount growth gram positive rods, small amount growth presumptive ID, small amount growth gram positive cocci, negative for fungi after six weeks. The reporter considered the hypersensitivity reaction to be probably related to Infanrix administration. As of 9/30/02, the outcome of the event was unknown. Note: the medical record noted that the lot number for the 10/29/01 injection of Infanrix was DTPA989; however, this is not a valid lot number. The medical record noted that the lot number for the 1/7/02 injection of Infanrix was DTPA527; however, this is not a valid lot number.