Age: 39.0
Sex: M
Vaccine: LYME
Symptoms: Fatigue, Headache, Joint swelling, Liver disorder, Musculoskeletal stiffness
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. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of LYMErix (unknown). On an unspecified date after vaccination with LYMErix, the subject experienced joint pain and swelling, stiffness, fatigue, neurological problems, severe headaches, night sweats, liver problems, connective tissue disorders, decreased activities of daily life, 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 a medical office billing summary. The subject was 39-years-old at the time of vaccination with LYMErix on 14 April 2000. No further information was received. Follow up information was received on 19 September 2007 via medical records. The subject was evaluated on 27 October 2006 and 15 March 2007 for pain management. Complaints included low back pain, neck pain, and fatigue, and treatment included Percocet. On 05 January 2007, the subject underwent magnetic resonance imaging of the cervical and lumbar spine which showed that the subject was status-post anterior fusion from C4 to C6, with degenerative changes. Additional findings included degenerative changes of lumbar spine and small disc protrusion at L5 to S1. On 30 March 2007, the subject underwent computed tomography (CT) guided facet blocks due to osteoarthritis. Diagnostic findings at that time included mild degenerative changes at C4/5. It was also noted that the subject was status post anterior cervical fusion at C5/6. Fatigue persisted upon re-evaluation on 26 April 2007. On 14 June 2007, he was examined for sciatic nerve/ low back pain which radiated down the right and left posterior legs and was described as "severe and sharp". The subject noted that these symptoms had been ongoing since 12 November 2005, and were alleviated with Percocet and prednisone. Additionally, he complained of shortness of breath with and without exertion upon evaluation on 14 June 2007. Treatment included Percocet, Motrin, and Medrol dose pack. A progress note dated 26 June 2007 indicated that the subject had osteopenia as well as persisting neck and low back pain. He was instructed to take calcium and vitamin D, and Omnicef was also prescribed on that date for an unspecified indications (certain physician's annotations were illegible). The event of shortness of breath and the findings of spinal fusion performed on unspecified date(s) were considered to be incidental findings upon medical record review. Diagnostic findings on 21 March 2007 showed no evidence of active cardiopulmonary process. Follow up information was received on 03 November 2008 via medical records. The subject was seen by an otolaryngologist in July 2000 due to recurrent sinusitis, headaches, occasional tinnitus, and reflux symptoms. In August 2008, the subject was evaluated by a neurologist due to severe headache that was treated with a single dose of sumatriptan. The subject reported being under stress and noted that an otolaryngologist had placed him on Augmentin for an unspecified reason. The neurologist indicated a possible diagnosis of chronic paroxysmal hemicrania. The subject was also diagnosed with chronic rhinosinusitis and seasonal allergies with associated severe headaches and intractable cough. These, as well as the events of sinusitis, tinnitus, and reflux, were assessed to be incidental findings during review of medical records. Follow up information was received on 30 July 2009 via medical records. The subject reported that he was vaccinated with LYMErix in 1999. The subject underwent bilateral knee arthroscopies in 1993, 2000, 2003, and 2004. In June 2004, the subject reportedly "on disability for his knees", and was noted to have arthritis of the shoulders, hips, and knees. Between May 2004 and March 2008, the subject was followed for cervical herniated disc/cervical spondylosis with upper extremity radiculopathy, right brachial plexus neuropathy by nerve conduction study (2004), possible thoracic outlet syndrome, muscle twitching, aching, tiredness, tingling in hand, hand redness, neck pain, low back pain/radicular pain (since a 12 November 2005 motor vehicle accident with whiplash injury), sciatica, shoulder pain, arm pain, lower extremity pain, myofacial pain, mechanical low back dysfunction, lumbar spinal stenosis, lumbar osteorthritis, headaches, bilateral knee pain/ osteoarthrosis in both knees. He was also noted to be status post bilateral carpal tunnel surgery and bilateral ulnar transposition. On 07 June 2005, a neurologist commented that "with the history of Lyme disease vaccine being administered in 1999, it is possible that the patient is having a long-term adverse reaction", and the subject was referred to a rheumatologist and/or infectious disease specialist. The neurologist's impression included suspected right brachial plexus neuropathy, multiple nerve injuries in the upper extremities due to overuse, possible relationship of history of Lyme vaccine, and status-post cervical disc surgery. On 27 June 2005, the subject was evaluated due to neck pain, arm muscle twitching/fasciculations, hand pain/ numbness/ tingling, and atrophy. Clinical diagnosis was suggestive of additional causalgia-like small diameter myelinated A-delta and unmyelinated C-afferent pain fiber involvement likely associated with cervical discogenic degenerative disease and right and left upper limb postoperative scar formation. In September 2005, it was noted that the subject continued to have intermittent diffuse musculoskeletal pain following hospitalization for pericarditis that was presumed to be viral in etiology. It was noted that the subject's clinical course did not "fit the classic features of an inflammatory arthropathy". Treatment included physical therapy, Skelaxin, Cymbalta, Vioxx, L5/S1 bilateral facet injections, Motrin, Percocet, Aleve, and cortisone and/or methylprednisolone injections in the knees. In November 2007, the subject "felt a tear in his left knee", and was subsequently diagnosed with left meniscal tear as well as bilateral knee pain. On 30 January 2008, the subject underwent bilateral knee arthroscopies with partial chondroplasty of the medial right femoral condyle, and partial left medial and lateral meniscectomy and partial chondroplasty of the medial femoral condyle. He continued to experience knee pain six weeks later, in March 2008. This report was assessed to be medically significant by GSK based upon follow up information.