Age: 43.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Fatigue, Headache, Joint swelling, Laboratory test abnormal
Clinical narrative: This report describes leg pains in a 43 year old male who received Lyme disease vaccine LYMErix. This report was received as part of the litigation proceedings, with forwarding of medial records. The subject's past medical history included testing positive for the HLA-DR4 antigen, chronic ear infections, sinusitis, tick bites, left knee pain and warmth (1997), foot pain (1998), gout versus polyarthritis (January 1999), alcohol consumption, and no known drug allergies. Surgical history included hemorrhoidectomy, repair of deviated nasal septum, and excision of an epidermoid cyst on the left buttock (1998). Family history included a "very strong" history of gout and two sisters and one brother with arthritis. Concomitant medications included Augmentin, Keflex, Z-pak, Levaquin, Cortisporin Otic, DayQuil, NyQuil, guaifenesin, Entex PSE, Tylenol, fluticasone, Proventil, Serevent, prednisone and vitamins NOS. The subject received his first injection of LYMErix on an unspecified date and his second injection on 8/2/99. On 9/24/02, in a Statement of Injuries, his attorney alleged that the subject "has suffered severe pain in her sic knees and pain and swelling of soft tissues around her sic knees. In addition, the subject has suffered disabling pains in her sic legs, severe headaches and fatigue." Following the reported onset of leg  pains, the subject experienced increased serum concentration of alanine aminotransferase, asthmatic bronchitis, upper respiratory infections, otitis media, otitis externa, bronchitis, nocturia, paroxysmal nocturnal dyspnea, low back pain for which he received chiropractic, and excessive snoring. These events were not reported as adverse events due to vaccine administration but were found during the course of review of the subject's medical records. Therefore, they are not listed as adverse events. The following info was obtained from medical records. The subject presented to the vaccine provider on 4/25/00 with complaints of right knee and ankle swelling, which began one week prior to presentation, when the subject twisted his ankle. He also reported feeling feverish and experiencing "diarrhea off and on." The physician noted the subject's history to be positive for "tick bites." The physician's assessment was "arthritis pain/swollen ankle, tick bites." X-rays were negative. The subject returned to the vaccine provider on 5/9/00, reporting that his right ankle continued to swell at night. The physician's assessment was arthralgia and tendonitis of the right Achilles tendon. He prescribed physical therapy. The subject was evaluated by another physician on 7/18/00. At that time, the subject reported that after his second LYMErix injection, he experienced fevers, sweats and "severe" pain in the dorsum of both feet. His "whole" right leg swelled, then the inner aspect of his right knee hurt. He experienced a dull pain up to his right knee from his ankle right ankle and some pain in his upper arm and left hand "was broken." He also reported lack of energy, diarrhea, "night sweats-not on a regular basis," "some memory loss," and "occasional" tenderness of the left knee. On physical examination, the physician noted tenderness of the right shoulder, metacarpophalangeal joints "first and second left," right medial knee, right ankle and "right metatarsal." The physician prescribed Vioxx and Levaquin. The subject remained under the care of this physician until at least 11/19/01. Serologies for Lyme disease were negative. On 4/12/01, the subject presented to another physician for a complete physical examination. Under review of systems, the physician noted "loose stools on occasion," nocturia, and "arthralgias after Lyme vaccine-feet. Worried about HIV." The subject was taking no medications. Physical examination was unremarkable. The physician's assessments were "1. well. 2. nocturia. 3. arthralgias." He recommended discontinuing alcohol consumption. The subject remained under the care of this physician until at least 6/19/02. The following additional signs and symptoms were reported during this time: left leg swelling, left foot swelling, right knee swelling with pain, sweats, fever to 101 degrees Fl, cough, chest congestion, wheezing, difficulty breathing, excessive snoring, and daytime somnolence and fatigue. The subject reported that his left knee started swelling when he was on a hunting trip. The physician noted that the subject had also been hunting in swamps 15 months previously, where he had incurred mosquito bites and had brief swelling of the left lower extremity. On 9/19/01, the physician noted "moderate diffuse, non-pitted edema LLE. R/O elephantiasis." Serologies for Lyme disease and filariasis were negative. The physician made additional diagnoses of right otitis externa and media (8/29/01), paroxysmal nocturnal dyspnea (8//29/01), upper respiratory infection (3/13/02), bronchitis (3/22/02) and asthmatic bronchitis (4/1/02). The physician prescribed Z-pak, Levaquin, Cortisporin Otic, proventil, fluticasone, Serevent, prednisone, guaifenesin and Entex PSE. On 9/16/01, the subject was evaluated in an ER while on a hunting trip. His chief complaint was painful swollen left leg. The subject reported that he 'has had problems with arthritis, particularly involving his left leg, for approximately one year. These symptoms began after he had received a vaccine for Lyme disease and subsequently apparently developed some type of arthritic condition as a result of the vaccine. He states he has been on a hunting trip for the past week to ten days. During that time period, he developed increasing swelling and pain in his left knee." Examination of the knee "shows the presence of an effusion. The knee is warm but is not erythematous." The physician aspirated approximately 60 cc of clear, straw-colored fluid. Subsequent analysis of the fluid was interpreted as not representing an acute infectious process. The physician's assessment was 'exacerbation of arthritis, left knee." the physician administered Motrin 800mg orally, Demerol 50mg IM and Phenergan 50mg IM. He prescribed Vioxx and Anexsia. On 10/3/01, the subject was evaluated by an orthopedic surgeon. At that time, the subject reported that he had swelling in his legs "for about one day" after receiving the second injection of LYMErix. He also reported that while hunting, he "did a six mile walk the first day to scan out the area and in fact, noted the presence of swelling in the right knee that night. The following day he could hardly walk on the knee. He was sent to a hospital where apparently 90cc of clear fluid were removed. He did not improvement with Vioxx and analgesics recently and was better this weekend but now his symptoms are back again." On physical examination, the subject was limping. The physician noted, "There is not profound swelling at all in the foot, calf or thigh todya. All of his findings are essentially in the knee. He has exquisite tenderness in the medial joint line, pain with McMurray's testing. Range of motion is limited from approximately 20 degrees to 80 degrees, no instability. No patcllofemoral exepitus. Slight swelling in the knee. My concern at this point in time is internal derangement, medial meniscal tear left knee. I am going to send him directly for an MRI scan." The results of the MRI performed on 10/9/01 were interpreted as abnormal. The surgeon prescribed Indocin. The subject underwent arthroscopic surgery of the left knee on 10/26/01. Post-operative diagnoses were medial and lateral meniscal tears and chondrocalcinosis in plica band. Synovitis of the right knee was also noted and 35cc of synovial fluid were obtained. The subject remained under the care of this orthopedic surgeon until at least 1/24/02. During this time, the subject also reported burning pain in his feet. The physician noted, "This has been a problem that he has had for two years and he was advised by a Lyme specialist that this is a reaction to his Lyme immunization." On 11/8/01, the physician noted, "he had complete relief of his burning foot pain after he took the single dose, presumably as a result of the single dose of Ancef he received in the hospital. I doubt the surgery itself would have caused bilateral foot improvement. Nonetheless, his symptoms are back to where they were before. Because of this, I suggested that he see an infectious disease specialist." On 1/7/02, the subject was "walking in the woods hunting. He felt a pop, had pain, kept going nonetheless. Last night 1/9/02 he began to note swelling in the knee." The orthopedic surgeon aspirated 105cc of fluid from the right knee on 1/10/02, just prior to the subject traveling. The surgeon prescribed Celebrex. MRI of the right knee revealed abnormalitis, and the surgeon recommended arthroscopic surgery on 1/28/02. The subject was evaluated by an infectious disease specialist on 11/15/01. At that time, the subject reported that "after the second dose of LYMErix he had swelling of his joints and sweats for about a month and therefore he did not take the third dose. He had occasional swelling of his knees, ankles and feet lasting less than one day. Apparently his symptoms begna less that one week after his second shot of LYMErix. He has had no sweats or other systemic symptoms, just swelling of his joints." On physical examination, the physician noted that the subject's "first metatarsophalangeal joints were both swollen and red and his left knee was slightly swollen and red." The physician prescribed Vioxx and colchicine on 11/15/01. The subject remained under the care of this infectious disease specialist until at least 1/27/02. On 11/29/01, the subject reported that he had pulled a tick off his right knee on 10/27/01. The site was "a little red" on 10/28/01 and "pretty red" on 11/29/01. On 12/20/01, his left knee was still swollen, but his feet were "100% better" with no redness or pain in his first metatarsal joints bilaterally. The right knee was swollen. The physician aspirated 40cc of clear yellow fluid from the right knee. the fluid was sent for a number of tests, which were interpreted as "essentially unremarkable" and not consistent with acute Lyme disease. The physician wrote, "Despite the lact of gout crystals in his knee, I am troubled by the fact the first metatarsal joints bilaterally are involved and he has a very strong family history of gout." The physician elected to gradually taper the subject off Vioxx and colchicine and prescribed allopurinol. The physician wrote, "I think this is a very complicated case and there are multiple possibilities for his swollen joints. He could be having a protracted reaction to LYMErix vaccine which apparently has occurred in some people and given the fact he is DR4f positive on his histo compatibility genes, it is possible he could have had this reaction to the vaccine. The other possibility is that we already know that he had a torn meniscus on one side and might have problems with anatomic derangement of the opposite knee, which may be a separate problem from the gout tha the has in his big toes." On 1/27/02, the subject reported that he had been in Mexico. After drinking ale, he "had flare of gout. Before this knee swelled up suddenly. Took 170cc out of knee. Fluid clear. Felt better but filled back up." After his knee felt better, his first toe became swollen and painful. "Celebrex helped knee. Toe took about five days. Much better on colchicine. This occurred on 300mg/day of allopurinol." The most recent info, received on 9/24/02, did not provide the outcomes of the reported events. This info reported leg pains as "disabling"; therefore, this report has been reclassified as serious, unexpected.  Reported on 02/27/2003: "On 03/14/2002, the subject reported "Flare of toe-four days ago".  He reported that he began to take colchicine, and was "now better".  On physical examination, there was no swelling in the left knee, the right knee was "better since surgery".  The right large toe was "slightly swollen/red".  The physician prescribed colohecine and rofecoxib (Vioxx).  The subject was to resume taking allopurinol after seven to ten days.  Information received on 09/24/2002 reported leg pains as "disabling"; therefore, this report has been reclassified as serious, unexpected.  The most recent information received on 02/13/2003, did not provide the outcomes of the reported events. A 15-day follow up report received on 05/20/2003 adds no new info. The most recent info, received on 10/1/03, did not provide the outcomes of the repoted events.  Follow up on 10/28/2003: "On 10/08/2002 the subject was evaluated in the ER two days after falling off a ledge and injuring his right knee and left wrist.  He complained of pain and swelling in his knee and pain in his wrist.  X-ray of knee and wrist revealed abnormalities; please see Lab Data section.  The subject was treated with naproxen (Naprosyn), an ice pack and knee immobilizer was applied.  He was also instructed to limit his weight bearing activity.  Information received on 09/24/2002 reported leg pains as "disabling"; therefore, this report has been reclassified as serious, unexpected.  The most recent information, received on 10/15/2003, did not provide the outcomes of the reported events."  Follow up on 01/20/04: "The most recent information, received on 01/05/04, did not provide the outcomes of the reported events." Follow up on 03/24/04 states: "Information received on 09/24/02 reported leg pains as "disabling"; therefore, this report has been reclassified as serious, unexpected. The most recent information, received on 03/16/04, did not provide the outcomes of the reported events."