Age: 64.0
Sex: M
Vaccine: LYME
Symptoms: Red blood cell sedimentation rate normal, Rheumatoid arthritis, Rheumatoid factor negative, Synovitis, Tenosynovitis
Clinical narrative: This case was reported by a lawyer and described the occurrence of joint pain and swelling in a male subject of unspecified age who was vaccinated with LYMERIX.  A physician or other health care professional has not verified this report.  On an unspecified date the subject received unspecified dose of LYMERIX (unknown).  On an unspecified date after vaccination with LYMERIX, the subject experienced pain and swelling in his joints, fatigue, possible autoimmune disease, decreased activities of daily life, and possible neurological injuries.  At the time of reporting the outcome of the events was unspecified.  This information was received via a Statement of Injuries.  Follow up information was received on 08 August 2008 via medical records.  According to a Lyme serology information sheet completed by the subject, he received LYMERIX on 19 March 1999 and 19 April 1999.  The subject's history included Lyme disease diagnosed in October 1998, and he indicated symptoms associated with or in relation to Lyme disease including fatigue, chronic pain, joint swelling, mental health/memory problems, and rheumatoid arthritis; he did not indicate which, if any, of these symptoms occurred subsequent to LYMERIX.  He was unsuccessfully treated for Lyme disease.  He reported joint swelling/fluid in the wrists, ankles, and knees subsequent to the second dose of LYMERIX.  The subject attributed the following symptoms to LYMERIX: lethargy, fatigue, joint pain (hands, knees, feet, ankles).  At the time that he completed the questionnaire, medications included Remicade for arthritis, prednisone, naproxen, and azathioprine.  Based upon this information, this case was assessed by GSK to be medically significant.  The subject received LYMERIX on 19 March 1999 and 19 April 1999.  At the time of his second LYMERIX vaccination on 19 April 1999, he continued to feel fatigued "a lot of the time", associated with past Lyme disease.  In late May 1999, he developed severe stiffness and increased arthralgias particularly of the ankles, hips, and wrists.  On 02 June 1999, he experienced progressive arthralgias symptoms; it was also noted that he had fallen down and hurt his hip.  The subject presented on 19 June 1999 with a chief complaint of a three to four week history of wrist swelling, reduced but painless hip motion, and some swelling/"fullness" in the hands and feet.  Impression was inflammatory polyarthritis of unclear etiology, with a history of acute Lyme disease and Lyme vaccination.  The evaluating physician commented that the subject had "symmetrical findings in the hands and feet, which does raise the possibility of rheumatoid arthritis".  The physician noted that the symptoms were possibly related to LYMERIX, or could be the result of post-viral arthritis.  Naproxen was prescribed.  He returned on 18 August 1999, and examination resulted in an impression of symmetrical inflammatory polyarthritis secondary to Lyme vaccine versus seronegative rheumatoid arthritis.  Medications include glucosamine chondroitin, Celebrex, and hydroxychloroquine.  On 10 September 1999, impression was inflammatory polyarthritis secondary to Lyme vaccine versus seronegative rheumatoid arthritis.  He returned on 15 and 20 October 1999, with symptoms including moderate synovitis of the hands and feet and pitting edema.  It was noted that he had little response to nonsteroidal anti-inflammatory drugs, Plaquenil, and low dose prednisone.  Other medications included methotrexate.  At that time, there was "no evidence supporting the diagnosis of Lyme disease".  On 15 October 1999, both knees were injected with lidocaine/Celestone with little relief.  Final diagnoses on 03 November 1999 by the consulting rheumatologist included seronegative inflammatory polyarthritis.  Treatment included physical therapy, and the dose of methotrexate was increased.  On 20 December 1999 he was diagnosed with degenerative arthritis of the wrist and "what appears to be rheumatoid arthritic changes of the middle finger metacarpophalangeal joint", as well as right severe carpal tunnel and flexor tenosynovitis of the index and middle finger.  On 29 December 1999 he was reportedly not responding to methotrexate and hydroxychloroquine, and Imuran was added.  On 01 March 2000, it was noted that the physician believed the patient had been adequately treated "but there certainly is a question that he could have residual infection as a background for his really progressive severe arthritis", and the subject was treated with a course of intravenous Rocephin via a peripherally inserted central catheter.  By April 2000, the subject's seronegative rheumatoid arthritis was "symptomatically better" on Enbrel.  Through 2000 and 2001, he continued to experience joint pain and swelling and low grade rheumatoid activity.  In 2003 and 2004, inflammatory polyarthritis was characterized as stable; on 10 December 2003 he complained of limited right shoulder motion but no joint swelling.  The subject was evaluated by his rheumatologist on 10 June 2005, 09 December 2005, 20 February 2006, 26 June 2006, 09 February 2007, 08 June 2007, 16 November 2007, 16 May 2008 for inflammatory polyarthritis of remitting and increasing severity, joint damage, and mechanical joint pain.  As of 16 May 2008, inflammatory polyarthritis was "under good control with Remicade".  As of 24 June 2008, the subject continued to receive azathioprine, Remicade, and naproxen.  The subject was followed by his primary care provider through June 2008 for complaints including rheumatoid and inflammatory arthritis, knee joint swelling and pain, backache, elbow swelling/bursitis, malaise, fatigue, and history of Lyme disease.  In June 2006, it was noted that he experienced a flare of symptoms when Remicade and azathioprine were interrupted; the medications were resumed with improvement of symptoms.  Remicade was interrupted in approximately October 2005 after his "disease was basically in remission", and azathioprine was stopped in January 2006.  On 13 October 2005, he received a course of doxycycline after pulling off a tick.  On 20 February 2006, he was assessed with active inflammatory polyarthritis with a two week history of recurrent pain and joint swelling, and Remicade and azathioprine were resumed.  On 14 September 2006, he was placed on doxycycline for Lyme exposure.  On 25 April 1999 the subject was evaluated in the emergency room for chest contusion after running into a fence.  On 20 December 1999 he was seen for right severe carpal tunnel and flexor tenosynovitis of the index and middle finger.  In December 2005, he developed toe cellulitis.  On 20 May 2008 and 05 June 2008, the subject was seen after falling from a ladder (on 19 May 2008) and twisting his ankle, accompanied by mild joint swelling.  He was diagnosed with foot sprain.  He was seen on multiple occasions post-LYMERIX vaccination for tick bites.  These were assessed to be incidental findings upon medical record review.