Age: 61.0
Sex: M
Vaccine: LYME
Symptoms: Myalgia, Nervous system disorder, Neuropathy peripheral, Pain in extremity, Paraesthesia
Clinical narrative: This case was reported by a lawyer and described the occurrence of joint pain in a male subject of unspecified age who was vaccinated with LYMERIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unknown date the subject received unspecified dose of LYMERIX (unknown). At an unknown time after vaccination with LYMERIX, the subject experienced joint pain, joint swelling, influenza like symptoms, tingling of extremity, fatigue, numbness, muscle pain, weakness, burning sensation throughout his body, possible memory loss, decreased ability to perform daily activities, rheumatological symptoms, neurological impairment, cognitive impairment and autoimmune disease. 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 via a claimant interview on 09 April 2009. The subject reported receiving three LYMERIX injections on 01 July 1999, 30 July 1999 and 10 July 2000. He claimed that "muscular and nerve disorders" began in the fall of 1999 and the first quarter of 2000. The subject reported that he experienced a number of symptoms which all began at the same time. He additionally claimed the symptoms went through phases of high and low intensity. The subject claimed to have muscle aches and weakness especially in his thigh muscles. He also claimed to have tingling in his nerves and "migrating hot spots" across his abdomen. He said that his feet and arms felt numb. He also reported that he had trouble with balance and coordination. He also reported joint pain. The subject felt that these symptoms were attributable to LYMERIX and they were continuing at the time of reporting. He reported a catheterization with onset 2005 resulting in stent placement and the development of diabetes in January 2009, both of which were not related to LYMERIX per the subject. Medications reported included aspirin, Atenolol, Lipitor, Actonel, Metformin, Vicodin, Hydrocodone, Celebrex, Vioxx, Zithromax, Tylenol, Advil gels, Motrin, Cipro, Toprol XL, Plavix and Pravachol. Follow-up information received on 09 April 2009 via medical records. The subject received the first and second doses of LYMERIX on 01 July 1999 and 30 July 1999. On 24 November 1999, the subject presented with a puncture wound in the left thumb and also complained of pain in the right third digit "related to an injury about a year ago". Assessment included right hand arthritic pain, and he was treated with Vioxx. On 29 February 2000, he was experienced paresthesias of the feet and noted indicated "discuss neuropathy". Further study was advised. On 06 March 2000, electromyography showed mixed sensory/motor peripheral polyneuropathy with minimal demyelinating motor and sensory axonopathic changes. On 09 March 2000, he was noted to have evidence of polyneuropathy and possible demyelinating disorder. He presented for neurology evaluation on 20 March 2000 with complaints of abnormal sensation in toes bilaterally that had been progressing over approximately one year. Recent diagnostic testing showed mild peripheral neuropathy and mild carpal tunnel syndrome bilaterally. On 21 September 2000 he noted that peripheral neuropathy was not "bothering him at the present time". On 26 October 20001, the subject complained of posterior right lower rib pain, and was treated with Vioxx. On 28 November 2001, complaints included right thigh pain radiating to the buttocks and femur. Between 15 March 2002 and 29 October 2003, he was evaluated for myalgias. On 06 January 2003 and 27 February 2003, he presented with leg pain and weakness, and assessment included ataxia, dysmetria, and large fiber sensory changes with neurophysiological evidence of an underlying peripheral neuropathy. He described a history of symptoms beginning approximately three years prior and including rib cage pain, burning sensation and sensitivity to touch at T8 level, intermittent burning of the right thigh/patella/infrapatella region, difficulty climbing stairs, and weakness of lower extremities. The subject noted that he had received LYMERIX vaccinations and was concerned "that this may have something to do with onset of the symptoms". Treatment included Celebrex and Vioxx. On 16 July 2003, he was seen for follow up and reported improvement since his last visit, with periodic symptoms. He declined further testing. This case was assessed to be medically serious by GSK based upon follow up information.