Age: 55.0
Sex: M
Vaccine: LYME
Symptoms: Biopsy skin abnormal, Blindness, Blood immunoglobulin G normal, Blood immunoglobulin M, C-reactive protein normal
Clinical narrative: This case was reported by a lawyer and described the occurrence of loss of concentration in a 61 year old male patient who received LYME disease vaccine recombinant OspA (LYMErix) injection for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date, the patient received LYMErix. At an unknown time after receiving LYMErix, the patient experienced " severe joint pain, fatigue, loss of concentration, and insomnia". Time to onset, treatment, and outcome were not reported. This report describes a 61-year-old male subject who received LYMERIX injection. A physician or other health care professional has not verified this report. On an unspecified date, the subject received LYMERIX. At an unknown time after receiving LYMERIX, the subject experienced "severe joint pain, fatigue, loss of concentration, and insomnia". Time to onset, treatment, and outcome were not reported. A statement of injuries was received on 05 May 2006 via medical records. The subject received LYMERIX on 28 April 1999 and 28 May 2009. Following the initial vaccine, the subject developed hip soreness. By June 1999, "shortly" after receiving LYMERIX, the subject developed sacrococcygeal pain, burning pain in the shoulders and arms, and some sharp pains in the fingers and toes, followed by neuropathic pain. It was noted that he intentionally attributed symptoms to injury after sitting on hard/cold ground and leaning against a tree for a prolonged time. He was diagnosed with chronic coccydynia in cold September 1999, initially treated with injections of XYLOCAINE and DEPOMEDROL. Other diagnosis at that time included osteoarthritis and insomnia. In October 1999 or November 1999, he underwent resection of the coccyx which was unsuccessful at alleviating his pain, and was complicated by a postoperative infection that "may actually have increased (his pain)". On examination on 18 February 2000, the subject continued to experience sacrococcygeal pain following a regimen of physical therapy. The evaluating physical noted that the pain was likely multifactorial in etiology, probably caused by a combination of "the precipitation condition, the surgery, and the post-surgery complications". On 03 November 2000, assessment included coccydynia, arthralgias and myalgias, HLA DR4 positive, positive IgG bands on Western Blot, fatigue, and sleep disturbance. Treatment involved AMYTRIPTYLINE which was noted to be working better that pain medicines. He was diagnosed with fibromyalgia, and the evaluating physician stated "my hypothesis is that he had a reaction to the infection he had with coccydynia. I doubt that it relates to Lyme vaccine and his genetic predisposition, although I cannot be confident about that." In July 2000, the subject was reportedly diagnosed with Lyme disease characterized by chronic fatigue syndrome, and chronic pain and swelling in his fingers and knees. No reportedly also experienced mental health/memory problems. In May 2001, the subject presented with neuropathic pain in the sacrococcygeal region, with radiculopathy and neuropathic pain of the S2 nerve root, which was treated with epidural nerve bloc with subsequent relief. Other treatment included NEURONTIN and RELAFEN. The subject was hospitalized from 16 July 2002 to 18 July 2002 for evaluation of noncardiac chest pain and to rule out possible myocardial infarction. While hospitalized, the subject complained of chronic shooting neuritic type pain and body stiffness. At the time of discharge, diagnosis included "inflammatory arthritis secondary to LYMERIX vaccine" and chronic pain. In January 2003 and February 2003, complaints included neck and upper back pain, and diagnostic evaluations revealed degenerative disc disease, spondylosis, and osteoarthritic changes. On 02 May 2003, the subject was diagnosed by magnetic resonance imaging with a small right lateral disc hernia at L5-S1 and mild degenerative disc bulging superimposed on facet arthropathy. On 27 May 2003, the subject was seen in follow up by a pain management specialist. The pain was characterized as "extremely debilitating", and treatment included NEURONTIN, VICODIN, and CELABREX. In June 2003, chronic sacrococcygeal pain was treated with a trial of dorsal column stimulation. By 25 June 2003, he experienced approximately 20 percent pain relief, and on 02 July 2003 the dorsal column stimulator was removed. On 07 January 2004, the subject was referred to a neurologist for re-evaluation of sacral pain, in addition to complaints of hand pain and "burning numbness" in his shoulders. The subject reported past treatment that included OXYCONTIN, HYDROCODONE, PROPOXYPHENE, CYCLOBENZAPRINE, IBUPROFEN, PREDNISONE, and LORAZEPAM. Sensory testing showed generally normal pinprick sensation in the extremities. Impression was coccydynia, without identification of any changes that might be suggestive of a neurologic process. According to a progress note dated 22 June 2004, the subject had been diagnosed with chronic pain syndrome and advanced arthritis of the thoracolumbar spine, and chronic inflammatory arthritis secondary to Lyme vaccine. Additional problems included pelvic pain, low back pain, and peripheral neuropathy. The subject received physical therapy in June and July 2004, and underwent a nerve block in October 2004, According to a letter written by his primary care physician on 16 March 2005, the subject was "unable to drive, let alone sit or stand for long periods of time" due to severe back pain and chronic medical illness. Treatment with LIDODERM PATCH was prescribed. On 23 September 2005, diagnostic testing demonstrated L5-S1 degenerative disc and facer disease. In March 2000, the subject was diagnosed with a herpes zoster rash on his chest. On 28 May 2002, the subject underwent a septoplasty for treatment of sinusitis. Other events included chest pain for which the subject was hospitalized in February 2001 and July 2002, intermittent dizziness, hearing loss, and vision loss. There were considered to be incidental findings upon review of medical records. Follow up information was received on 30 January 2007 via medical records. Medical history included traumatic amputation of left hand digits 2 through 5 in 1977. On 10 May 2006, the subject underwent magnetic resonance imaging of the brain due to continued memory loss, stinging sensation in his fingers and nerve damage. The results of the MRI indicated a normal brain pre and post contrast, mild subcortical deep white matter leukoaraiosis on the basis of chronic small vessel ischemic change, mild mucosal thickening of the ethmoid air cells, separated right sphenoid sinus, no evidence of any enhancing lesions of the brain post contrast, and mild inflammatory retention cyst involving the floor of the left maxillary measuring 1 centimeter. Follow up information was received on 07 February 2007 via medical records. According to an information sheet completed by the subject, he was diagnosed with Lyme disease in July 2000 with symptoms including chronic fatigue, mental health/memory problems, joint swelling and pain in the fingers, knees, toes, and hips, and inability to sit due to sacral area pain. Additionally, the subject noted that he had experienced pain and redness at the injection sites, lasting approximately two weeks after vaccination with LYMERIX. The subject was evaluated 13 February 2003 for a four to six-week history of "rather insidious" onset of neck pain, scapula pain, and headaches with some paresthesias in the right upper extremities. Electromyographic findings included cervical paraspinal irritability with normal findings throughout the right upper extremity and shoulder girdle musculature, considered to be suggestive of right cervical radiculitis. Electrical findings were suggestive of mild median neuropathy at the wrist, without electrical evidence of significant ulnar neuropathy. The subject underwent an initial physical therapy evaluation, but did not return for scheduled therapy visits. On 07 June 2004, he was again evaluated for physical therapy due to complaints of back pain, decreased active lumbar range of motion, decreased flexibility, increased pain, tenderness to palpation, and decreased strength. Physical therapy was planned for twice weekly for five weeks duration. In August 2006, the subject received intravenous Immunoglobulin. Follow up information was received on 31 March 2007 via medical records On 17 April 2006, electrodiagnostic studies showed polyneuropathy with multifocal abnormalities and superimposed carpal tunnel syndrome. On 18 April 2006, a skin biopsy showed low epidermal nerve fiber density in the right leg, with normal right thigh and borderline normal forearm epidermal nerve fiber density results, assessed to be consistent with small fiber neuropathy. Neurological examination showed pain in the seated and supine positions, with stocking and glove sensory lose to vibration, cold temperature, and light touch, imbalance of stance and gait, mild weakness in the proximal and distal leg muscles, inability to hop, mildly hypoactive tendon leg reflexes, and intact cognition and cranial nerves. According to the evaluating neurologist, findings were consistent with "post-LYMERIX peripheral small and large fiber neuropathy and dysautonomia". In July 2006, his primary care physician characterized his condition as "chronic pain syndrome status post LYMERIX vaccination", and noted that the subject continued treatment with "chronic narcotics, anticonvulsants, anti-inflammatories with minimal relief to the point that he is unable to work, disabled". Follow up information was received on 25 April 27 via orthopaedists records. On 15 September 1999, pathological diagnoses based on evaluation of coccyx tissue included focal degenerative change and fragmentation of surface cartilage. In October 1999, he experienced pain and some serious drainage around the surgical site. Following coccygectomy, the subject did not return to work until approximately November 1999. 3/25/2010 Follow up information was received on 17 may 2007 via medical records. On 26 April 2007, the subject's neurologist provided an expert opinon summary to the subject's lawyers following reveiw of medical records, stating "It is my expert opinon to a degree of medical certanity that this patient suffered from painful large and small fiber peripheral neuropathy and coccydynai caused by LYMERIX vaccination. These injuries are permanent and disabling. "Accordign to a letter written by the neurologist dated 12 June 2006, the subject developed hip and nuropathic complaints "several weeks" following vaccination with LYMERIX on 26 April 1999, with an exeacerbation following the second LYMERIX vaccine on 28 May 1999. The neurologist stated that finding were "consistent with post-LYMERIX dysimmune peripheral small and large fiber neuropathy and dysautonomia". Follow up information was received on 16 november 2007 via medical records, which confirmed tha tthe subject's coccygectomy was performed on 15 September 1999. Between February 2000 and Pril 2000 the subject was examinde for myalgias and back pain, and on 04 February 2000 Lyme testing (ELISA) was positive. Follow up information was received on 07 January 2007 via medical records. THe subject was diagnosed with bilateral deep vein thrombosis characterized by leg pain, and was hospitalized from 10 July 2007 to 20 July 2007. Intake records indicated that the subject underwent a coccygectomy in 1999 due to "back and sacral pain secondary to LYMERIX vaccination and immune stimulation". At the time of discharge, it was also noted that the subject had "chronic pain with inflammatory polyneuropathy secondary to LYMRIX vaccination and exposure  and immune mediation", as well as degenerative joint disease. He had previously been treated with immunoglobulin for chronic pain and inflammatory autoimmune polyneuropathy secondary to LYMERIX vacciantion, and was reported to have undergone back stimulation, epidurals, and pulse frequency ablation for back pain, Notes indicated that the subject  also experienced leg/ankle  swelling. Concurrent diagnoses included chronic pain syndrome, chronic neuropathy, and limb and back pain. According to an anticoagulation clinic visit noted dated 24 September 2007, the subject was being followed by pain clinic, and his dose of gabapentin had been recently increased.  Other medications included Oxycodone and Neurontin. In late march 2007 or early April 2007, the subject experienced a "sharp intense pain in his shoulders' after "shoveling sidewalks out of his yard", and reported that magnetic resonance imaging of the shoulder was negativie fora  tear but showed tendonitis of the rotator cuff. He was subsequently enrolled in physical therapy from 11 April 2007 and 30 April 2007, and was also treated with oxycodone, Celebrex, and pain patches. The subject was diagnosed with bilateral deep vein thrombosis chareacterized by leg pain, and was hospitalized from 10 July 2007 to 20 July 2007. Dep vein thrombosis was treated with Coumadin and Lovenox. These events were assiesed to be incidental findigns upon review of medical records. Follow up information was received on 04 June 2009 via medical records. on 20 March 2007, impression of the subject's condition by a pain clinic physician included "neuropathic type pain related to LYMERIX vaccine", and he was instructed to increase gabopentin. By 09 April 2007, the subject ahd completed intravenous immunoglobulin injections for post-LYMERIX vaccination with snsory neuropathy "thought to be secondary to that process". There was no change in symptoms with IVIC. Impressions included small fiber snsory plyneuropathy "possibly a post LYMERIX vaccination reaction", and chronic low back and coccya pain. On 12 September 2007, the subject was seen for evaluation at a pain clinic with an impression of worsening low back pain following discontinuation of Lidoderm, recent deep vein thrombosis, status post LYMERIX vaccine with associated pain, hypertension, enlarged prostate and opioid tolerance. Medications at the time included OxyContin, and Lidoderm was restarted. On 23 February 2008, the subject re ported discomfort in his legs since being off Coumadin, stating that it felt like deep vein thrombosis did.