Age: 36.0
Sex: F
Vaccine: LYME
Symptoms: Back pain, Blood immunoglobulin G normal, Blood immunoglobulin M, Borrelia burgdorferi serology, Borrelia burgdorferi serology negative
Clinical narrative: This case was reported by a lawyer and described the occurrence of rheumatological symptoms in a female subject of unspecified age who was vaccinated with LYMERIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of LYMERIX. According to the statement of injuries, at an unspecified time after vaccination with LYMERIX the subject experienced "arthralgias, myalgias, cognitive dysfunction, facial swelling, and fatigue" as well as "rashes, swollen joints, swollen feet, and gastrointestinal problems". The statement of injuries also alleged that the subject experienced "rheumatologic, neurologic, and/or cognitive impairment of an autoimmune, immune-mediated, or other mechanism all caused by vaccination with LYMERIX including but not limited to those set forth above", and that she experienced "decreased activities of daily life and decreased ability to participate in recreational activities". At the time of reporting the outcome of the events was unspecified. Follow up information was received on 29 July 2008 via medical records. The subject's medical history included arthritis, depression, fatigue, joint pain, kidney stone, leg cramps, low back pain and Lyme disease. She also had past subcapsular syndrome treated with hydrocortisone and MARCAINE. She had been hospitalized in the past (1989) for Lyme arthralgia. She received her first dose of LYMERIX on 01 March 1999. on 15 March 1999, she experienced "supposed swelling/ rash, not confirmed" as well as aching. It was noted that the subject "swears she had Lyme disease before getting the vaccine; taken doxycycline for several years for Lyme even though never confirmed". On 10 December 2001, she was evaluated for post-Lyme vaccine syndrome and elbow epicondylitis. She was treated by a "Lyme specialist" and medications included VIOXX and ULTRAM. On 15 March 2002, she reported that "the LYMERIX injections have caused her to have a lot of symptoms". On 27 December 2002, she complained of Lyme signs and symptoms and requested ZITHROMAX. On 01 July 2003, she was seen for follow up of chronic Lyme disease that had been treated with doxycycline. By 03 May 2004, it was noted that her Lyme disease was "fairly well controlled with ZITHROMAX". On 19 December 2005 she was seen by an orthopedist for follow up of a left ankle sprain and chronic right knee pain. Treatment included a corticosteroid injection to the knee as well as application of ice. A progress note dated 24 April 2006 indicated that she had "intermittent Lyme flare-ups relieved with antibiotics". According to a rheumatologist's summary dated 05 March 2008, the subject had allegedly had Lyme disease approximately ten years prior, and at the time of the notes reported bilateral knee pain treated with oral antibiotics. She had been off and on courses of antibiotics "over the years leading up to now" for "what she claims has been Lyme disease". She noted receiving the Lyme vaccine "about three years after her initial diagnosis" and reported that "immediately following the vaccine she developed polyarticular pain and has had this pain ever since with stiffness in the morning". Rheumatologist's impression included inflammatory arthritis with secondary fibromyalgia. It was noted that post-Lyme arthritis remained a possibility but "less likely as this is a polyarticular distribution and post-Lyme arthritis is typically mono-arthritic". Prednisone was discontinued, and MEDROL started. In August 2003 she reported fatigue, not eating right, and not sleeping properly but noted that she was "on shift work" and had "a couple of kids that are in trouble, etc.", for which she was prescribed ZYPREXA. On 23 May 2005, she was diagnosed with cervical sprain syndrome. On 17 October 2005, the subject fell down steps and experienced a sprain of the left ankle. On 25 January 2007, she pulled a muscle in her back resulting in back pain. On 28 December 2007 she was involved in an automobile accident resulting in shoulder and arm pain. These were assessed to be incidental findings upon medical record review. Follow up information was received on 06 October 2008 via medical records. The subject had a history of Lyme disease diagnosed as early as October 1989, for which she received long-term treatment. On 15 March 1999, two weeks after her first LYMERIX vaccine, she presented with swelling in her hands and body aches. On 29 March 1999, she was placed on dexamethasone, LASIX, and ATARAX. On 10 December 2001, physician's notes indicated "she is apparently a victim of the Lyme vaccine post vaccine syndrome". Medications at that time included VIOXX, ULTRAM, CLARITIN, and ATARAX. Assessment included Lyme disease and epicondylitis. In March 2008, radiology findings included osteoarthritis in the first carpo-metacarpal joints bilaterally, and an erosion involving the third metacarpal head consistent with rheumatoid arthritis. She was seronegative for rheumatoid arthritis. She returned for rheumatology follow up on 26 March 2008, and it was reported that x-rays of the hands and wrists were consistent with osteoarthritis. MEDROL was continued and she was placed on vitamin D as well. She was again seen for rheumatology follow up on 30 June 2008, with impression of likely seronegative rheumatoid arthritis. She continued to experience fibromyalgic pain with soreness of the arms. MEDROL was held, ATARAX dose increased, and methotrexate and folate were initiated. Follow up information was received on 03 November 2008 via medical records. On 01 March 2000, a progress note indicated that the subject's "vaccine symptoms are back?" and diagnoses included Lyme disease and treatment resistant arthritis. On 10 January 2001, the subject complained of swollen joints, body aches, and pain. On 03 February 2001, the subject was diagnosed with post-vaccine arthritis that was non-responsive to treatment, and autoimmune disease. Medications included VIOXX and prednisone. On 15 August 2001 and 19 September 2001, the subject was evaluated for Lyme symptoms/ a flare of Lyme disease with associated joint pain, swelling, and aching "all over". Treatment included doxycycline. Follow up information was received on 05 January 2009 via medical records. On 11 November 2000, the subject presented with a flare-up of "Lyme vaccine symptoms" including swelling, and itching, with treatment including prednisone and ATARAX. The subject was reportedly advised that she had Crohn's and rheumatoid arthritis "in the past with secondary fibromyalgia, likely from LYMERIX vaccination". In March 2008, rheumatoid factor was within normal limits, and it was noted that in spite of her Crohn's diagnosis there was no stigmata of Crohn's arthropathy "although this remains a possibility, but less likely as this is a polyarticular distribution and post-Lyme arthritis is typically mono-arthritic". A progress note dated 24 July 2008 indicated that the subject was diagnosed with "new onset Lyme", had had LYMERIX in the past, and required "long-term" doxycycline therapy.