Age: 45.0
Sex: M
Vaccine: LYME, LYME
Symptoms: Arthralgia, Asthenia, Back pain, Cognitive disorder, Fatigue
Clinical narrative: This report described the occurrence of joint pain in a 45 year old male pt who received LYMERIX vaccine. 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 pt's attorney reported that the pt received injections of LYMERIX on May 13, 1999, Oct 18, 1999, and June 14,2000 according to the client. However, office notes from the vaccine provider indicated that the pt received injections of LYMERIX on 13May99, 17June99, and 14June2000. On 03Sept03, the pt's attorney alleged that the pt 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 pt presented for treatment of back spasms. The physician prescribed FLEXERIL. The pt returned to the vaccine provider on 24Jan00 with a complaint of 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 pt's attorney. Medical treatment records received provided the following additional information: The pt's relevant medical history included floaters since approximately 2981, shoulder pain concussion and headaches. On 28June01, a form completed by the pt 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 13May02, the pt was seen by an ophthalmologist for worsening blur of left eye. The ophthalmologist stated that the pt's symptoms could be explained simply by the need for astigmatism correction. MRI of lumbar spine without contrast was performed on 14May02. Impression: Mild spondylotic changes. Small focal far lateral disc beyond the forearm on the right at L1-L2. MRI of the brain was performed on 15May02. Impression: Incidental increase in perivascular space with no focal lesion identified. No suspicion of demyelinating plaques, hemorrhage, infarct, or mass.  The pt was seen by a neurologist on 06June02 for evaluation of numbness and paresthesias in legs. The pt described an approximate two year history of recurring discomfort in right leg including a recurring dull aching pain in the thigh. Symptomatology at times involves the lateral thigh more than 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 being stretched at times. The pt also had recurrent low back pain. He described no distinct weakness of the lower extremities and no distinct bowel or bladder dysfunction. Other symptoms included paresthesias of both hands; however no distinct pain or discomfort in regards to the cervical region no radicular pain. The pt noted rare mild episodes of vertigo and described legibility of penmanship. The pt described difficulty sleeping at times and being under a significant amount of stress. He described at times that his speech was stuttering. Impression: Rule out right lower extremity and upper lumbar radiculopathy. Rule out carpal tunnel syndrome.  Question a diffuse neuromuscular syndrome possibly related to antiphospholipid syndrome. On 06June02 two views of the right hip showed mild degenerative subchondral sclerosis along the superior lateral portion of the acetabulum. Bending 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 14June02 showed no change since May02. No development of new focal lesion. No abnormal parenchymal or meningeal enhancement. On 17June02, 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 in the conus, lumbar spondylosis or stenosis. On July02, the pt was seen in a rheumatology clinic. Neurologic symptoms were stable. The pt had dysesthesias in his hands. He also had numbness in his right leg. The physician commented that they were hoping that this 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 pt was noted to have an elevated lipid profile and the physician commented that there was an issue about myalgias that the pt had had when he took atorvastatin (Lipitor), so there are some concerns about possibly restarting the therapy in the face of musculoskeletal symptoms. On Oct 15, 2002, the pt was seen in a 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 pt had some symptoms related to the positive antiphospholipid assays and that the pt's low back symptoms seemed to be radiculopathic. The physician's impressions were as follows: Depression for which PROZAC was prescribed, Musculoskeletal symptoms on LIPITOR which was discontinued; Positive antiphospholipid; Radiculopathic symptoms. The pt was evaluated on 10Dec02 and was noted to be doing reasonably well in terms of his lower back pain. His radicular symptoms had improved significantly. The pt was noted to have significant exhaustion. His cognitive 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 pt was seen by a physician on 24Jan03 with throat discomfort last 2 weeks. Uvula was noted to be swollen. Amoxicillin was prescribed. Following the reported onset of the alleged events, the pt 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 pt's medical records. Therefore, they have not been listed as adverse events. On 15Sept2004, the pt's attorney alleged that the pt, now 50 years old, experienced severe cognitive losses, fatigue, tingling, headaches, and right sided weakness. Time to onset, treatment, and outcome were not reported.