Age: 46.0
Sex: F
Vaccine: LYME
Symptoms: Blood immunoglobulin G, Blood immunoglobulin M, Blood product transfusion, Borrelia burgdorferi serology negative, Catheterisation cardiac
Clinical narrative: This case was reported by a lawyer and described the occurrence of joint pain in a 45-year-old female subject who was vaccinated with LYMERIX. A physician or other health care professional has not verified this report. The following information was received via an interview between the subject and attorney (s). The subject's medical history included ankle fracture, carpal tunnel release cheilitis, deviated septum and removal of gallbladder. Concurrent medical conditions included brain lesion, carpal tunnel syndrome, corneal dystrophy, Crohn's disease, episcleritis, gastroesophageal reflux disease, Hashimoto's thyroiditis and hypertension. On 17 June 1999, 20 July 1999, and 14 June 2000 the subject received the first, second, and third dose of LYMERIX (unknown). In August 1999, less that one month after the first vaccination with LYMERIX, the subject experienced pain in the finger joints. In the spring of 2000 the patient developed vertig/disequilibrium. In June 2000, less than 1 month after vaccination with LYMERIX the subject experienced jerking of limbs. In July 2000 she developed dry mouth, swallowing difficult, speaking problems, tremor, numbness in hand, grip strength decreased, decreased perception, fatigue, decreased concentration, hair loss, irregular heartbeat, premature ventricular contraction, fever spike, metallic taste, ringing in ears, and memory deficit. In the summer of 2004, the patient experienced nerve pain in the legs and hands. Treatment included intravenous immunoglobulin (IVIG), an unspecified attention deficit hyperactivity disorder medication, and unspecified medications to treat vertigo/disquilbrium. At the time of reporting the events, with the exception of hand tremors, treaperature spikes, and hair loss, were unresolved. Follow-up information was received on 05 January 2009 via medical records. According to a medical summary of events, prior to the provided dates of LYMERIX vaccination the subject was diagnosed with Crohn's disease with small bowel resection, episcleritis, arthritis secondary to Crohn's disease, corneal dystrophy, Hashimoto's thyroiditis, multiple allergies, degenerative joint disease, fibromyalgia, ankle sprain, carpal tunnel syndrome, 1089, when she was bitten by a tick and experienced rash and joint pains. During or prior to 1997, she was diagnosed with myofascial pain syndrome, central disc herniation, degenerative cervical spine disease, fibromyalgia, and shoulder impingement. She experienced onset of "true vertigo" in 1998. On 25 February 1998, echocardiography findings included mild aortic sclerosis, left ventricular diastolic dysfunction, mild mitral leaflet thickening, and mild left atrial enlargement (findings consistent with small pericardial effusion). After receiving LYMERIX, she reportedly developed Lyme disease treated with intravenous Rocephin via a peripherally inserted center catheter, as well as vancomycin (August 2000, recurrence February 2002 and August 2002), angina pain following foot surgery (December 2003, hospitalized), and coronary vasospasm. ON 03 December 2003 she underwent "closing bone wedge osteotomy first right metatarsal with modified McBride procedure first right metatarsophalangeal, and underwent cardiac chatherization in December 2003. The subject was treated by a neurologist for relapsing/ remitting multiple sclerosis (possibly diagnosed in 1980; although other notes indicated a possible a diagnosis of multiple sclerosis in April 1998), as evidenced by optic neuritis (onset in 1998), poor balance, frequent falls, and fatigue. Steroid treatment was ineffective. Magnetic resonance imaging of the brain showed white matter lesions as early as 1998, with an increase in lesions in 2003. The subject was also diagnosed with autoimmune disease treated with Rocephin and vancomycin. On 09 October 2000, she presented with increased dizziness and lightheadness, with resulting impressions of Lyme disease and benign vertigo. On 14 April 2003, impression included chronic fatigue and fibromyalgia and it was noted that spinal tap studies were all normal. In July 2003, she was evaluated for a tick bite and six weeks later experienced abrupt onset of bilateral knee pain, palpitations, dysrhythmia, balance impairment, dysequilibrium, scattered muscle twitching and myoclonus, prominent fatigue, prominent memory deficits, intermittent confusion, and disorientation. Subsequently, she developed stiff neck, severe generalized pain, swallowing dysfunction and choking, irregular heart beat, focal neurological changes with myoclonus bilateral lower extremity clonus, decreased deep tendon reflex, and tongue fasciculation. Diagnositc findings included multiple foci of demyelination. On 20 October 2003, the subject underwent Holter monitoring due to arrhythmia, with results described as "benign". On 23 December 2003, she was diagnosed with a coronary spasm following chest pain/angina that was relieved with nitroglycerin. Coronary spasm with frank dysrhythmias was responsive to diltiazem. Other medications during the course of her treatment included Tramadol, Celebrex, and Neurontin. In 2004, she experienced worsening of bilateral lower extremity weakness. Prior to 30 August 2004, she experienced a fall resulting in closed head trauma, hepatic contusion, and torn hamstring requiring physical therapy. On 27 September 2004, she was noted to have progression of antalgic gait and posterior leg pain with L4/L5/S1 radiculopathy, and progression of neurogenic claudication. She reportedly also had left lower extremity hemiparaparesis with hyporeflexia. On 06 October 2004, electromyography showed some electrophysiologic evidence of a mild chronic neurogenic process affecting the lower extremities, most consistent with mild L4/55 radiculopathy. On 01 March 2005 nerve biopsies performed due to bilateral lower extremity numbness and gait difficulties were consistent with small fiber neuropathy. Recommendations included intravenous immunoglobulin (IVIG) therapy.