Age: 45.0
Sex: M
Vaccine: LYME, LYME
Symptoms: Paraesthesia, Radiculopathy, Similar reaction on previous exposure to drug, Spondylitis, Vision blurred
Clinical narrative: Arthralgia, Influenza like illness, Fatigue, Paraesthesia, Headache, Asthenia, Cognitive deterioration, Visual disturbance. This report described the occurrence of joint pain in a 45 year old male patient who received Lyme disease vaccine recombinant OspA (LYMErix) for prophylaxis. This report was received as part of litigation proceedings and has been verified through subsequent receipt of medical treatment records through the litigation process. The patient's attorney reported that the patient received injections of LYMRix "on May 13, 1999, October 18, 1999, and June 14, 2000 according to the client." However, office notes from the vaccine provider indicated that the patient received injections of LYMErix on 13 may 1999, 17 June 1999, and 14 June 2000. On 03 September 2003, the patient's attorney alleged that the patient "suffered joint pain, flu-like symptoms, fatigue, tingling, headaches, right leg weakness, cognitive loss and vision problems after his first vaccination according to the client." Treatment and outcomes of the alleged events were not reported. Office notes from the vaccine provider did not record any adverse events after the first dose of LYMErix. On a date in 1999 after the second dose of LYMErix (date not legible), the patient presented for treatment of back spasms. The physician prescribed cyclobenzapine (Flexeril). The patient returned to the vaccine provider on 21 January 2000 with a complaint of a possible mole that was painful near his left nipple. The physician observed a possible cyst near the left areola. None of the alleged events were recorded in any of the office notes provided by the patient's attorney. Medical treatment records received provided the following additional information: The patient's relevant medical history included visual floaters since approximately 1981, shoulder pain, concussion and headaches. On 28 June 2001, a form completed by the patient indicated that he had not had an eye exam in approximately 18 years and that he was not having major trouble with his eyes. He had a 20 year history of experiencing small floaters. He experienced blurred vision after reading a while and saw halos or streaks around lights at night. He indicated that he was experiencing "fuzzy" vision. On 13 May 2002, the patient was seen by an opthalmologist for worsening blur of left eye. The opthalmologist stated that the patient's symptoms could be explained simply by the need for astigmatism correction. MRI of lumbar spine without contrast was performed on 14 may 2002. Impresssion: Mild spondylotic changes. Small focal far lateral disc beyond the foreamen on the right at L1 - L2. MRI of the brain was performed on 15 may 2002. Impression: Incidental increase in perivascular space with no focal lesion identified. No suspicion of demyelinating plaques, hemorrhage, infarct or mass. The patient was seen by a neurologist on 06 June 2002 for evaluation of numbness and paresthesias in legs. the patent described an approximate two year histor of recurring discomfort in right leg including a recurring dull aching pain in the thigh. symptomatology at times involves the lateral thigh more thatn the medial. In regards to the medial aspect of the thigh, he notes a sharp, shooting bee sting type of sensation or a sensation that the thigh is bing stretched at times. The patient also had recurrent low back pain. He described no distinct weakness of the lower extremities and no distinct bowel or bladder dysfunction. Other symptoms inluded paresthesias of both hands; however no distinct pain or discomfort in regards to the cervical rgion no radicular pain. The patient noted rare mild episodes of vertigo and described being genrally fatigued. Other symptoms of slight decrease in manual dexterity in right hand with decreased legibility of penmanship. The patient described difficulty sleeping at times and being under a significant amount of stress. He described at times that his speech ws stuttering. Impression: 1. rule out right lower extremity and upper lumbar radiculopathy. 1. Rule out carpal tunnel syndrome. 3. Question of a diffuse neuromuscular syndrome possibly related to antiphospholipid syndrome. On 06 June 2002 two views of the right hip showed mild degenerative subchondral sclerosis along the superior lateral portion of the acetabulum. Bendng views of the lumbar spine showed no evidence for acute fracture or abnormal motion. Three views of the sacroiliac joints demonstrated no evidence for bony fusion or destructive bony lesion. No fracture was seen. MRI of the brain on 14 June 2002 showed no change since May 2002. No development of new focal lesion. No abnormal parenchymal or meningeal enchancement. On 17 June 2002, MRI of the cervical spine showed a normal study with no focal lesion identified to indicate contusion, mass, abnormal enhancement or demyelinating plaques. No disc herniation. MRI of the thoracic  spine appeared normal including contrast enhancement. Normal-appearing thoracic spinal cord and with no abnormal enhancement. MRI of the lumbar spine showed no suggestion of abnormal enhancement, focal abnormality i the conus, lumbar spondylosis or stenosis. On July 2002, the patient was seen in a rheumatology clinic. Neurologic symptoms were stable. The patient had dysesthesias in his hands He also had numbness in his right leg. The physician commented that htey were hoping that his was related to mechanical problems, although with his positive antiphospholipid titer, having had Lyme vaccination, concerns are raised about demyelinating process and also other neurologic problems associated with antiphospholipid. The patient was noted to have an elevated lipid profile and the physician commented that there was an issue about myalgias that the patient had had when he took atorvastatin (Lipitor), so there are some concerns about possibly restarting the therapy in the face of musculoskeletal symptoms. On October 15, 2002, the patient was seen in rheumatology clinic and was noted to have had low back pain radiating down his right leg, positive antiphospholipid antibodies, and positive Lyme titers status post vaccination. The physician commented that it was not clear whether the patient had some symptoms related to the positive antiphospholipid assays and that the patient's low back symptoms seemed to be radiculopathic. The physician's impressions were as follows: 1. Depression for which fluoxetine (Prozac) was presribed; 2. Musculoskeletal symptoms on storvastatin (Lipitor) which was discontinued; 3. Positive antiphospholipid; 4. radiculopathic symptoms. The patient was evaluated on 10 December 2002 and was noted to be doing reasonabl well in terms of his lower back pain. His radicular symptoms had improved significantly. The patient was noted to have significant exhaustion. His cognifitive skills were seemingly not as sharp as they were previously. He had difficulty reading and comprehending. He had problems with memory. Antiphospholipid anti-beta-2-glycoprotein 1 was over 50. His IgM anticardiolipin was positive. The patient was seen by a physician on 24 January 2003 with throat discomfort last 2 weeks. Uvula was noted to be swollen. Amoxicillin was prescribed. Following the reported onset of the alleged events, the patient experienced the following: back spasms, hemorrhoids with rectal bleeding, prolonged QT interval, a possible cyst, night sweats, back problems at L4-L5, scalp tenderness, tinnitus, questionable hearing loss, chest pain, areolar nodule, ankle injury, shortness of breath on exertion, forearm laceration , hiatal hernia, Schatzki's Ring, hand injury, rash, irritable bowel syndrome, mood disorder, insomnia, vertigo, stress, stuttering and depression. These events were not reported as adverse events due to vaccine administration, but were found during the course of review of the patient's medical records. Therefore, they have not been listed as adverse events. On 15 September 2004, the patient's attorney alleged that the patient, now 50 years old, experienced "severe cognitive losses, fatigue, tingling, headaches, and right sided weakness." Time to onset, treatment, and outcomes were not reported. Follow-up information was received on 13 Novembere 2007 via a statement of injuries which alleged that the .... suffered from "pain and swelling in his joints, flu-like symptoms, fatigue, tingling in his extremities, ...loss, cognitive problems, visual problems, muscle pain and weakness, and decreased activities of daily life". Additionally, he experienced "rheumatologic, neurologic, and/or cognitive impairment of an autoimmune, immune-mediated, or other mechanism, all caused by vaccination with LYMERIX, including but not limited to those set forth above".