Age: 70.0
Sex: M
Vaccine: LYME
Symptoms: Pleural effusion, Pyrexia, Rheumatoid arthritis
Clinical narrative: This report described the occurrence of rheumatoid arthritis in a male pt who received Lyme disease vaccine recombinant (LYMErix) for prophylaxis. This report was received as part of litigation proceedings, and has not been verified by a physician or other health care professional. The pt's attorney stated, "Vaccinations occurred as follows: no dates for first two, March 22, 2000 and May, 9, 2001 according to the client." A fourth dose of LYMErix is not recommended. On 9/3/03, the pt's attorney alleged that the pt "suffered bilateral knee effusions, fatigue, pleural effusions, nosebleeds, fever, chills, and myalgias within weeks of his fourth dose according to the client." Treatment and outcomes of the alleged events were not reported. Medical treatment records received through litigation proceedings provided the following information: The pt's relevant medical history included possible erythem amigraine chronicum treated with doxycycline, left knee bursitis, and sarcoidosis. Relevant family medical history included arthritis in the pt's sibling. Records indicated that the pt received four doses of Lyme disease vaccine recombinant, the primary series with doses on the following dates: 3/12/99, 4/9/99 and 3/22/00 and a fourth "booster" dose on 5/9/01. On 5/18/01, the pt complained of intermittent shoulder, arm, and back pain and occasional nosebleeds. He was advised to take Tylenol as needed. He was evaluated by a physician on 5/23/01; the physician's impression was myalgias and questionable viral syndrome. Hematocrit: 40.1%, WBC 11600, LYme (Western blot) was negative. He was prescribed Celebrex 200 daily/ twice daily, and on 5/25/01, Doxycycline 100mg twice daily. On 5/31/01, the pt presented with chest pain, increased sed rate (88), and fatigue. Hematocrit 42.3%, WBC 12500, CPK 45, ANA negative. Chest x-ray showed swelling on the right with effusion. The physician commented that the findings were most consistent with viral pleurisy. On 6/13/01 the physician's impression of the pt's exam was "bilateral pleural effusion/ pleurisy." Hematocrit 37.7%, WBC 12200, sed rate 88. The pt was to use Celebrex as only needed. Per a noted dated 6/25/01, the pt had discontinued Celebrex and started Tylenol and, beginning on 6/23/01, had swelling in the ankles and knees. On 7/2/01, the pt continued to have increased fatigue and decreased energy. He had bilateral knee effusions and bilateral 2+ pretibial edema. The physician's impression was history of pleurisy/ effusion, poly arthritis in knees, edema, rule-out immune mediated secondary to viral syndrome. Lyme vaccine, rheumatoid arthritis. He continued Celebrex and added Ibuprofen 600mg two or three times daily as needed. Urine 1.015 platelets, 1-3 WBC, few crystals, negative protein, sed rate 96, hematocrit 35.3, WBC 10800, albumin 3.1, ANA negative, rheumatoid factor negative. Pt was referred to a rheumatologist. Letter from rheumatologist to pt's physician dated 7/16/01 stated that the pt complained primarily of aching in his knees and ankles which was beginning to possibly improve. There may be some dyspnea, but this is difficult to assess. The pt's wife felt that the pt had lost weight-he was at his normal weight of 163, but felt that this was inaccurate as he is retaining fluid. Chest was clear with no rubs. There were no percussion changes suggesting a significant effusion. There was some edema of both legs suggesting that he did indeed have some fluid retention. The right wrist had synovial thickening and tenderness and restricted painful dorsiflexion. The knees displayed bilateral effusions with some pain on full flexion. Some swelling and pitting was noted in the ankles with slight tenderness suggesting possibly some synovitis. The right knee was aspirated, with withdrawal of 32cc of a turbid fluid. Examination of the fluid confirmed a definite inflammatory fluid with a white count of 11870-83% granulocyte. There were no crystals, essentially ruling out gout of pseudogout as an etiology. The remainder of the lab studies are worth noting, particularly the markedly elevated sed rate (77mm/hr) and c-reactive protein (14.8mg/dL). The Lyme test is negative, regarding which the rheumatologist stated that this was no surprise to him. The rheumatologist's impression was that he had little doubt that the pt had a systemic inflammatory process producing synovitis. He stated that he did not for a minute believe that this was Lyme disease. Secondly, he stated, there doesn't seem to be any convincing evidence that the problem was infectious. He added that the most likely candidate is in fact connective tissue disease. Rheumatoid would be a definite consideration, as middle-aged and elderly men can certainly get pleurisy as part of the picture. He stated that the rheumatoid factor at this point was negative, but that it was quite early. His other concern was that there was an occult malignancy or even progression of the pt's prostatic cancer that was triggered this syndrome. The pt was started on Prednisone 5mg twice daily. The rheumatolgoist stated that this syndrome, if in fact rheumatoid syndrome in this age, often responds dramatically to even small doses of steroids and then the use of a second-line agent, often simply Plaquenil, can be considered. Per the physician's note dated 7/24/01, the pt showed marked improvement on low dose Prednisone. He was started on Plaquenil and symptoms worsened. On 8/7/01, the pt was taking Plaquenil two daily and Prednisone 2.5mg daily. The leg swelling and achiness resolved except for mild left knee achiness. He had occasional sensation of mild chest achiness which was worse with deep breath. Physician's impression on 8/7/01 was left pleural friction rub/ pleurisy; left knee effusion/ edema.  Hematocrit 38.9%, WBC 7,900, sed rate 44. On 8/10/01, chest x-ray was normal, but there was a definite rub. Prednisone was increased to 5mg twice daily. Physician's note dated 10/18/01 indicated that the Prednisone was decreased to 5mg daily about three weeks prior. The pt was experiencing unstable balance and bowel changes questionably secondary to prostate radiation. The physician's impression included that the pleurisy was resolved; variant rheumatoid arthritis was improved and that he suspected that it was viral mediated and needed to rule out that it was secondary to Lyme vaccine. Hematocrit 44.4%, WBC 9,300, sed rate 25. He was to continue Prednisone at 5mg daily. It was noted that the pt was "off Plaquenil." On 2/7/02, Hematocrit was 48.6%, WBC 6,100, platelets 314,000, sed rate 18. Letter of consultation from otolaryngologist regarding his exam of the pt on 4/30/02for recurrent epistaxis stated that the pt had inforemd the otolarngogist that he had recurrent nose bleeds for years only on the right side. They occurred approximately once a month and his last episode had been on the previous day, 4/29/02. The exam revealed a bleeding point on his right anterior septum which was cauterized with silver nitrate following topical anesthesia. The pt was advised to decrease his daily aspirin to a baby aspirin rather than five grains and to discuss with his physician about the possibility of staying on 81mg a day. He was to use saline nasal spray and nasal gel and to return if he had further bouts of bleeding. Following the reported onset of rheumatoid arthritis, the pt experienced balance symptoms-unstable balance, bowel changes, bright red blood in stool, and left testicular hydrocele. These were not reported as adverse events due to vaccine administration, but were found during the course of review of the pt's medical records; therefore, they are not listed as adverse events. Additional lab data are available upon request.