Age: 52.0
Sex: F
Vaccine: LYME
Symptoms: Activities of daily living impaired, Antinuclear antibody negative, Arthralgia, Autoimmune disorder, Blood immunoglobulin G normal
Clinical narrative: This case was reported by a lawyer and described the occurrence of joint pain in an adult female subject who was vaccinated with LYMErix for prophylaxis. A physician or other healthcare professional has not verified this report. On an unspecified dose of LYMErix (unknown). On an unspecified date after vaccination with LYMErix, the subject experienced joint pain, swelling, headaches, fatigue, flu-like symptoms, possible memory loss, and decreased activities of daily life. In addition, she suffers from rheumatologic, neurologic, and/or cognitive impairment of an autoimmune, immune-mediated or other mechanism, all reported to be caused by vaccination with LYMErix. 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 19 July 2007 via medical records. The subject was a 51-year-old female at the time of vaccination with LYMErix and onset of reported symptoms. On an unspecified date, the subject complained of stiffening of the knees and wrists, with pain that she noted was worse following rest. Progress notes referenced LYMErix vaccine without further information. Physical examination on an unspecified date revealed creptius of bilateral knees. Subsequent records revealed that she received her initial LYMErix vaccination in July 1999. Concurrent medication included glucosamine/ chondroitin. On 23 August 1999, the subject complained of pain in her wrists, knees, and ankles with periodic swelling behind the knees, and assessment was of "most likely osteoarthritis". Diagnostic tests at that time indicated negative rheumatoid arthritis. On that date, 23 August 1999, she received her second LYMErix vaccine. A "few weeks" after receiving Lyme vaccine, the subject developed polyarthritis. In approximately September 1999, she was diagnosed with rheumatoid arthritis (RA), which was assessed to be medically significant by GSK. The subject presented for an initial rheumatology evaluation on 05 October 1999 for complaints of painful joints of approximately two months duration. The rheumatologist noted that "of interest is that these pains started in [July 1999] at the same time that she received her first shot of Lyme vaccine of which she took the second shot in [August 1999]." Physical examination revealed synovitis with synovial thickening and tenderness involving the second and third proximal interphalangeal (PIP), second and third metacarpophalangeal (MCP) on both sides, mild swelling over the dorsum of both wrists, synovial effusion over both knees. Impression was of a "clinical picture...very suggestive of rheumatoid arthritis which is so far seronegative; however, this could be as well Lyme." Treatment with Minocycline was initiated for three weeks because there had been no Lyme titer prior to receiving Lyme vaccine. A follow up note dated 12 October 1999 revealed that the subject had a positive Lyme titer (ELISA) with negative Western Blot, "hence, the possibility is that this is related to Lyme vaccine." Arthrotec was initiated, and the subject continued to experience persistent morning stiffness, articular pain, and fatigue. On 09 November 1999, prednisone and Azulfidine were added. In December 1999 the subject reported improvement of rheumatoid arthritis symptoms including joint pain an stiffness. However, by February 2000, she complained of worsening joint pain and stiffness after exercising "rather heavily", with "main" pain over both hands and involving both shoulders, assessed as "mild" flare. In April 2000, antiarthritic therapy included Azulfidine, Plaquenil, Arthrotec, and prednisone; on 04 April 2000 Arthrotec was discontinued and Celebrex was started. In May 2000, bone density testing was diagnostic of osteopenia. On 31 July 2002, the subject complained of right upper back pain. Rheumatology evaluation on 10 October 2002 showed clinical evidence of "both osteoarthritis mainly involving the distal interphalangeal (DIP) level as well as inflammatory synovitis involving the PIP and to a lesser extent the MCP level which has been so far seronegative." The rheumatologist further stated "it is speculative whether this is seronegative rheumatoid arthritis or Lyme vaccine induced inflammatory RA-like picture." She continued to experience stiffness mainly in the knees and hands; the subject also developed temporomandibular joint pains. Between 2000 and June 2003, the subject was under the care of a rheumatologist for symptoms including pain, stiffness, stiff/painful hands and knees, synovial thickening and tenderness, capsular distention, and morning stiffness. Treatment included Plaquenil, azulfidine, prednisone, Celebrex, and Arava. In December 2003, the subject was receiving Plaquenil and Arava and was doing "perfectly well clinically" with no significant morning stiffness and no joint pain. On 09 November 2004, the subject reported feeling fine with "no significant stiffness in the morning", and stated that her lifestyle had not been affected by the arthritis in her hands. Treatment included Arava and Celebrex. Radiology revealed "worsening" findings in the hands. On 25 January 2005, she was evaluated by a rheumatologist and noted feeling "slightly worse" with more swelling in the hands. Examination revealed swelling over the wrists and hand joints, and the dose of Arava was increased on that date. Between 2001 and 2004, the subject was evaluated for complaints including sinusitis, allergy symptoms, conjunctivitis, bronchitis, elevated C-reactive protein, and upper respiratory infection. In November 2001, she was diagnosed with mild leukopenia possible attributed to Arava. These were considered to be incidental findings upon review of medical records.