Age: 56.0
Sex: M
Vaccine: LYME
Symptoms: Borrelia burgdorferi serology positive, Cardiac electrophysiologic study abnormal, Cognitive disorder, Confusional state, Disturbance in attention
Clinical narrative: This case was reported by a lawyer and described the occurrence of stiffness in hands 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). At an unspecified time after vaccination with LYMERIX, the subject experienced stiffness in his hands, pain in legs and shoulders, lightheadedness, diffuse joint pain and swelling, tingling and numbness in his hands and lower arms, cognitive dysfunction, arthralgias, aches and pains in neck, wrist pains, swelling in hands, fatigue, loss of concentration, short term memory problems, headaches, morning stiffness in arms, possible neurological injuries, and decreased activities of daily life. At the time of reporting the outcome of the events were unspecified. This information was received via a Statement of Injuries. Follow up information was received on 07 November 2008 via an interview between lawyers and the subject. The subject received the first dose of LYMERIX on 01 September 1999. Two to three weeks after vaccination he experienced hand pain, shoulder pain, joint pain, and joint swelling. Five to six weeks after vaccination, he experienced leg pain, weakness, lack of concentration, fatigue, tingling, wrist pain, numbness of the lower arms and wrists, and short term memory loss. In 2001 he developed headaches. Treatment included unspecified pain medications. The events were unresolved at the time of reporting. Follow up information was received on 19 November 2008 via medical records. A note dated 04 August 1999 indicated that the subject "may sign up for Lyme clinic". The subject was vaccinated with LYMERIX in September 1999, and approximately four weeks later reportedly developed stiffness of the hands which resolved. On 22 November 1999, the subject reported hand swelling, wrist pain, joint pain and heat (hands, shoulders, knees), and fatigue. On 15 December 1999, the subject was evaluated for joint swelling. Treatment with doxycycline was initiated around that time. On 06/07 January 2000, the subject expressed concerns over symptoms of LYME disease, including wrist pain, shoulder pain, and loss of concentration. He was diagnosed with non-inflammatory arthritis and was treated with doxycycline. On 10 February 2000, he was evaluated by an internal medicine specialist for Lyme disease. Impression included arthralgias of unclear etiology, and the evaluating physician believed it unlikely that the subject's symptoms were associated with LYMERIX vaccination. Diagnostic testing revealed no evidence of arthritis of the hands. On 24 November 2000, he continued to experience chronic arthralgias and myalgias, and noted that his symptoms were "much improved" on Ceftin. A progress note dated 02 June 200q indicated "? Lyme", with complaints including continuous joint pain and headaches. The physician noted "I doubt highly that this is secondary to any kind of Lyme disease or activation by the LYMERIX vaccine". Ceftin was prescribed, which the subject noted "works well for him". The subject declined to be seen by a rheumatologist. Between 18 June 2001 and 13 September 2001, he presented to an internal medicine specialist reporting arthritis, fatigue, Lyme disease, and myalgias. In January 2003, the subject was receiving doxycycline. On 18 November 2003 he continued to complain of arthralgias, and was noted to be allergic to Lyme vaccine. Examination revealed "large nodules left Achilles tendon". The subject presented for neurology evaluation on 14 June 2007 due to suspected neuropathy. The subject reported that in 1999, approximately two to three weeks after receiving LYMERIX, he developed aching pains in his hands, followed by wrist, shoulder, and leg pain, numbness and tingling sensations in the arms and legs, frequent headaches, and dizzy spells. Electromyography and nerve conduction studies showed peripheral neuropathy that the neurologist indicated was "probably caused by the LYMERIX vaccination, given the temporal relation, but other possible causes should also be considered". According to a Lyme serology information sheet completed by the subject, he was vaccinated with LYMERIX on 01 September 1999 and refused other doses due to his adverse reactions. He reported that he had been treated for Lyme disease beginning in November 1999. Symptoms included fever or flu-like symptoms, fatigue, pain, swelling of or fluid in joints, numbness and tingling sensations in the hands and arms, headache, neck pain and stiffness, muscle pain, difficulty concentrating, "mental fog", and neck pain. Treatment included tetracycline. He described treatment as "partially" successful, noting that some symptoms remained and that other symptoms developed, while other symptoms improved. Based upon follow up information, this report was assessed to be medically significant by GSK.