Information has been received from a 61 year old female who on 8/27/01 was vaccinated with pneumococcal vaccine 23 polyvalent. Four to six hours, post vax, the pt's wrist and palm swelled up and became itchy. The pt did not take any medication for 2 days and the swelling spread to feet, thighs and right hand. The pt took diphenhydramine hydrochloride (Benadryl) that day and developed 8" hives in different parts of her body. Five days later, the pt took 4 or 5 days of prednisone. After the 5th day, hives reappeared and her whole face swelled up. Upon internal review, wrist and palm swelling, itching, 8" hives in different parts of her body, reappearance of hives, facial swelling and swelling in feet, thighs and right hand were all determined to be "Other Important Medical Events". Additional information has been requested. F/U has been received from a physician concerning a 61 year old female with asthma, a history of a benign growth on her arm and several episodes of facial swelling and hives with no known cause (unrelated to medications or vaccines) in the 1980's and no known food allergies who on 8/27/01 was vaccinated with a 0.5ml dose of pneumococcal vaccine 23 polyvalent (lot 637262/1068K). Concomitant therapy included fluticasone propionate (Flovent), salmeterol xinafoate (Serevent) and alendronate sodium (Fosamax). Four to six hours, post vax, the pt's left wrist and palm swelled up and became itchy. The pt did not take any medication for 2 days and on 8/29/01, the swelling spread to her feet, thighs, ankles and right hand. The pt took diphenhydramine hydrochloride (Benadryl) that day and on 8/30/01, developed hives on her inner thighs and waist area (trunk). It was noted that the pt was afebrile. Five days later, the pt took a 5-day course of methylrednisolone and 10mg qd cetirizine hydrochloride (Zyrtec). The reporter felt as though there had been probable antigen sensitivity to the recent pneumococcal vaccine 23 polyvalent injection. It was noted that the symptoms resolved, but then on 9/9/01, a single large hive on the right lateral aspect around the axilla appeared. On 9/11/01, sometime in the AM, the pt developed left facial swelling involving her left upper lip and was seen by a physician for a "questionable allergic reaction to pneumovax vaccine" on 8/23/01. It was noted that there was no dyspnea and that the pt was experiencing throat tightness. A physical exam of the pt's skin revealed the following results: "face; no erythema, mild swelling of left upper lip and left face right upper arm, lateral aspect proximal to axilla was well circumscribed erythematous edematous wheal 6-8cm that extended beneath the axilla to the upper right breast". The pt was afebril, had no chlls, weight loss, night sweats, fatigue or lymphadenopathy. Her BP was 120/70. The pt was dx'd with angioedema and urticaria. The pt was administered rofecoxib (Vioxx) 25mg qd and reported that she felt better. It was noted that there was less facial swelling and minimal pruritus. The pt was scheduled to see an allergy fellow and continued the 10mg qd cetirizine hydrochloride (Zyrtec). The pt was also administered fexofenadine (Allegra) 180mg and took the 1st dose in the physician's office. The pt denied recent ASA or NSAID use. It was noted that the subsequent reaction had an "unclear etiology". The reporter felt that urticaria and angioedema were related to therapy with pneumococcal vaccine 23 polyvalent. Upon internal review, angioedema and urticaria were determined to be "Other Important Medical Events".