Information has been received from a licensed practical nurse concerning a 75 year old white, retired male with chronic low back pain secondary to lumbar disc disease, glucose intolerance, Type IV hyperlididemia, hiatal hernia, degenerative joint disease of the hips, non-insulin dependent diabetes currently not requiring any oral agents, glaucoma, multiple allergies including Tobradex which caused an increased pressure in the eye and aggravation of his known glaucoma, Tylenol with codeine which caused vomiting, and Demerol and Sporanox both of which caused a problem in the past and a history of abdominal aortic aneurysm repair, cholecystectomy for cholecystitis, hemorrhoids, cardiac arrythmia by history which has been intermittent atrial fibrillation, surgical removal fo multiple small SC nodules from the arm and a remote history of psoriasis and diverticulosis who on 12/12/02 at 9:30 was vaccinated IM in the left deltoid with a dose of pneumococcal vaccine 23 polyvalent. The pt was stuck twice by mistake, but only one shot was given. It was noted that the pt was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (manuf unk) in approximately 1989 with no reaction. Concomitant therapy included Lanoxin 0.25mg one po daily, Celebrex 200mg one po daily Ultam 50mg po bid, Robaxin 750mg one po tid, chromion picolinate over the coutner, ginko biloba prn, aspirin 325mg one po daily and calcium supplement 600mg po bid. On 12/12/02, at approximately 1530 the pt developed swelling and a sever reaction at the injection site which spread to his "entire arm." It was reported that the pt contacted the office and took some Benadryl. Subsequently, the physician sent him to the ER where he declined taking steroids due to above noted allergy and was treated with an injection of Benadryl and was able to go home. On 12/13/02, the pt was seen in the physician's office where he pt noted that the swelling had decreased to a large degree. he had not taken any additional diphenhydramine. However, there was erythema and pain with motion of the left elbow and range of motion was restricted. There were two small needle marks noted at the lower aspect of the left deltoid without any surrounding localized erythema or induration at the injection site itself. The injection site itself did not appear to be abscessed and the edema and puffiness of the arm started below that level. The grip strength was equal and the pt moved the hand well on the left side. It was noted that there was erythema and pain with motion over the left elbow joint in the olecranon area. There was no numbness or tingling in the arm. Because of the increasing redness and swelling of the left arm, especially around the elbow area, the pt was admitted to the hospital for further management. On 12/13/02, the pt's temp was 98.4, blood pressure was 126/80, white blood cell count was 10.7, sedimentation rate was 2.3, glucose was 124, and the results of blood cultures were no growth at five days x two. The pt was started on ANCEF, the left arm was elevated, and his arm improved over several days. On 12/16/02, the pt was discharged to home on Keflex 500mg one po bid x 7 days. Subsequently, the physician reported it was possible that the pt had a reaction to the vaccine and that the amount of edema and fluid was worsened by compromise of lympatic channels in his arm. It was not entirely clear as to how much of this was from infection and how much of it could have been from the vaccine. It was reported that the pt "at this time" was fully recovered with no residual weakness, numbness, tingling or other problems. The reporter expressed a concern regarding the lot number. The records of testing prior to release of this lot have been checked by GMP Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional info is not expected.