Age: 29.0
Sex: M
Vaccine: LYME
Symptoms: Myalgia, Myelopathy, Nerve conduction studies normal, Nervous system disorder, Neuropathy peripheral
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 unspecified date the subject received unspecified dose of LYMERIX. At the time after vaccination with LYMERIX, the subject experienced joint pain, joint swelling, itching, numbness, possible memory loss, rheumatological symptoms, neurological impairment, cognitive impairment, autoimmune disease and decreased ability to perform daily activities. At the time of reporting the outcome of the events were was 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 was vaccinated with LYMERIX in February 1999, March 1999, and March 2000. In October 2000, the subject experienced joint and muscle pain. In December 2000 or January/ February 2001, he developed itching. In January 2001 and/or February 2001, he developed fatigue, motor skill problems, and feet numbness. In mid 2001, he experienced an inflamed spinal cord. With the exception of motor skill problems and spinal cord inflammation, the events were unresolved. Follow up information was received on 19 November 2008 via medical records. The subject had a family history of multiple sclerosis (MS). In the summer of 2000, the subject experienced an episode of numbness in his lower extremities. He was evaluated on 26 June 2000 due to numbness of both feet, and nerve conduction studies and electromyography were normal. Peripheral neuropathy persisted in July 2000. Other symptoms included right hand and arm paresthesias, right hand twitching, and right leg weakness. On 19 January 2001 the subject presented with constant weakness of the legs and arms for the past two weeks. On 29 January 2001 the subject complained of right arm bursitis. There were no obvious neuropathic changes at the time, and the evaluating physician stated "indeed he could be suffering from a syrinx although I want to see these films for myself". The subject was evaluated on 14 February 2001 by a neurosurgeon after experiencing a recurrence of lower extremity numbness for the preceding three weeks. The physician noted that magnetic resonance imaging showed a signal abnormality with minimal enhancement in the cervical spinal cord, suspected to be a demyelinating or other sort of inflammatory process. He was seen by a neurologist on the same day, who stated that the signal characteristics of the lesion were suggestive of an inflammation change of the cervical spinal cord. The subject underwent a spinal tap on 21 February 2001. On 16 April 2001, an infectious disease physician indicated that the subject had positive Lyme serology from Lyme vaccine in 1999 to 2000, with no evidence of Lyme infection. An office noted dated 19 April 2001 indicated that the subject had a negative Lyme work-up and "we still fell that [subject] is suffering from MS [multiple sclerosis]". On 24 July 2001 the subject complained of generalized joint pain and had been evaluated by an infectious disease specialist "in hopes of possibly undergoing treatment for Lyme disease to see if this makes any improvements". He was assessed to be stable from a neurologic standpoint. On 07 January 2002, progress notes indicated Lyme disease with aching joints and fatigue "secondary to vaccine". Between September 2003 and January 2004, he presented with fatigue, joint aches, dizziness, lightheadedness, benign positional vertigo, and urinary urgency and frequency. In late February 2003 to early March 2003, he experienced a sudden onset of numbness form the waist down. He had reportedly had no symptoms "since his myelopathy two years ago". Impression was that that subject's symptoms were probably due to demyelinating disease, with his second symptoms suggestive of a central neurological cause which was different from his initial symptoms; "this by definition would fit MS". On 25 February 2003, it was reported that the subject's prior symptoms were re-diagnosed as inflammation from the Lyme vaccine, and that the symptoms disappeared following prednisone therapy. At the time of the 25 February 2003 examination, he experienced lower bilateral extremities paresthesias with some recurrence of right arm symptoms "possibly related to spinal inflammation in the past". On 10 March 2003, his physician stated the subject "very well may have demyelinating disease, but I think it is worth pursuing the Lyme's aspect of this". On 16 February 2004, he was noted to have a history of inflammatory spondylitis "complaining Lyme vaccine, which has now largely resolved". The case was assessed to be medically significant by GSK based upon follow up information. During the course of treatment, the subject's medications included dexamethasone, prednisone, and doxycycline.