Information has been received from a registered nurse concerning an 86 year old female with asthma and lung disease and no known allergies who on 3/22/05 was vaccinated SC in the right deltoid with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine (lot # 640084/0605P). It was noted that she had been vaccinated before with pneumococcal 23v polysaccharide vaccine and had no problems. Concomitant therapy included a unspecified asthma medication, paroxetine hydrochloride, and temazepam. On 3/23/05, the patient presented to the office with her right arm red, swollen down to the elbow and warm to touch. The patient was on her way to the ER to be admitted with a diagnosis of cellulitis. She is being treated with antibiotics and methylprednisolone sodium succinate. The outcome is not recovered. No product quality complaint was involved. The nurse considered the patient's experienced to be disabling and an other important medical event (OMIC). Additional information has been received from a physician concerning the white female non-smoker with left adrenal adenoma, aortic stenosis murmur, bronchiectasis, hypertension, lung nodule, osteoarthritis, sulfa allergy, urinary incontinence, and a history of negative PPD-5 tuberculin unit skin test who on 3/22/05 at 10:30 AM was given her second dose of pneumococcal 23v polysaccharide vaccine. On the same day, at 1:00 PM, the patient developed cellulitis. On 3/23/05 the patient was admitted to the hospital with acute cellulitis reaction secondary to PNEUMOVAX vaccine and acute flare up of bronchiectasis. The patient was initially admitted to the telemetry unit in review of laboratory data and hospital course. She had significant aortic stenosis. Cardiac enzymes were drawn X3 eight hours apart and were negative. Electrocardiogram were negative for myocardial infarction (MI) and showed ejection fraction 65-70%, mild left ventricular hypertrophy, trace regurgitation mitral valve, left atrium normal size, aortic valve trileaflet, right atrium mildly dilated, right ventricle mildly dilated, and mild tricuspid regurgitation. On 3/23/05, laboratory tests revealed hemoglobin 11.1; hematocrit 35.6; white blood cell count 12,900; blood urea nitrogen 10; creatinine 1; and glucose 184. Treatment therapy for cellulitis included IV methylprednisolone sodium succinate, 40mg Q 8 hours; and IV vancomycin 1g daily. Treatment therapy for bronchiectasis included levofloxacin, initially 500mg daily, later changed to 50mg daily; and hand-held nebulizers with albuterol and ipratropium bromide QID. The patient was also administered ranitidine hydrochloride, 150mg Q 12 hours; cyproheptadine hydrochloride, 4mg Q 12 hours; and diphenhydramine hydrochloride, 25mg Q 6 hours. Two blood cultures were drawn 15 minutes apart and were negative. On approximately 3/25/05, while being treated with methylprednisolone sodium succinate 120mg daily, the patient developed significant confusion and delusions and was therefore transferred from her initial room to a room directly opposite the nurses' station. On 3/25/05, treatment with methylprednisolone sodium succinate was discontinued. A cranial computed axial tomography was performed to rule out cerebrovascular accident, and was negative. A carotid ultrasound was also performed and revealed mild plaques bilaterally but no significant stenosis. On approximately 3/25/05, during her confusional phase secondary to treatment with methylprednisolone sodium succinate, the patient did develop some dehydration. On 3/25/05 laboratory tests revealed hemoglobin 9.7; hematocrit 29.6; WBC count 23,000. On 3/25/05, the patient also had a chest CT which revealed: left adrenal adenoma unchanged, ill-defined incidentally right middle lobe and lingula patchy and anterior inferior portion of the right middle lobe and also had bronchiectasis involving the right upper lobe anterior segment and left upper lobe lateral segment. These were thought to be chronic changes to bronchiectasis although could not exclude entirely acute process. There was also a nodule located right upper lobe but that lateral segment but that has been unchanged from prior CT. On approximately 3/25/05, free thyroxine (T4) was 0.78 and the patient was placed on therapy with levothyroxine sodium. On 3/26/05 BUN increased to 28 and the patient was put on IV fluids (half normal saline). Her dehydration improved. On approximately 3/26/05 albumin was decreased at 2.8; protein was 5.5, and calcium was 8.2. On approximately 3/26/05 potassium dropped to 3.4 and the patient was placed on therapy with potassium chloride. It was reported the patient had vancomycin trough levels and was followed by pharmacy in terms of dosing. On 3/28/05 the patient's pulmonary function tests revealed force vital capacity 2.42 liters, 106%; forced expiratory volume 1.54, 101%; FEV/FEX ratio 64%; peak expiratory flow rate 4.57, 92%; and there was no significant change post bronchodilators. Lung volumes revealed total lung capacity 5.45, 122%; and predicted RV/TLS ratio increased at 55%, which indicated obstruction and air trapping. Arterial blood gases on room air revealed PO(2) 67; bicarb 28; O2 saturation 94%; and pH 7.46. Airway resistance was increased at 4.4, 297% of predicted. CO diffusion was not performed as it was reported the patient was not able to do that. The patient's cellulitis reaction of right upper extremity improved significantly and she also showed some improvement of her bronchiectasis. On 3/29/05, laboratory tests revealed hemoglobin 9.2; hematocrit 30; WBC 11,700; sodium 140l potassium 4; glucose 95; BUN 9; and creatinine 0.8. It was reported that the patient recovered from cellulitis and was discharged from hospital on 3/29/05. Discharge medications included trandolapril (+) verapamil hydrochloride 2-240 once a day; 2 gram sodium diet. The patient was to have an office visit in one week, with activity level limited only by her respiratory status. She was also instructed not to receive pneumococcal 23v polysaccharide vaccine in the future. The physician did not consider cellulitis to be disabling or an other important medical event. No further information is expected.