Age: 51.0
Sex: M
Vaccine: LYME
Symptoms: Insomnia, Laboratory test abnormal, Malaise, Neck pain, Palpitations
Clinical narrative: Report 2001002372-1 describes debilitating cervical arthritis in a 51 year old male who received Lyme disease vaccine recombinant. This report was received as part of litigation proceedings; medical records were forwarded. The vaccine provider submitted this report directly. The patient's medical history included generalized anxiety disorder, panic attack, globus pharyngeus, peptic ulcer disease, duodenal ulcer disease, gastritis, chronic dyspeptic symptoms, irritable bowel syndrome, gastroesophageal reflux disease, eczema, allergic rhinitis since the 1970s, allergy to hornets, dust, mold, ragweed, grass, trees, and dogs, allergy testing and desensitization since 1978, chronic sinusitis, otitis externa, benign prostatic hypertrophy, prostatitis, epididymitis, orchitis, presumed inflammatory disease of the lower urinary tract, erectile dysfunction induced by paroxetine and citalopram, hyperlipidemia, Morton's neuroma, degenerative disc disease (L3-4 and L4-5), recurrent disc herniation, lumbar radiculopathy, and chronic low back pain. On 1/10/95, the patient's neurosurgeon certified that the patient had 25% permanent disability of his spine. The patient denied medication and food allergies. The patient worked outdoors as a contractor. Surgical history included L4-5 discectomy, left inguinal hernia repair, appendectomy, tonsillectomy, and adenoidectomy. On 4/28/93, during a follow up visit for prostatitis and epididymitis, the patient reported vague joint pains and occasional difficulty getting out of bed. He was treated with a nonsteroidal anti-inflammatory drug. Degenerative joint disease was documented in physician office records beginning 3/8/98, affected joints were not specified. Following the reported onset of arthralgia, the patient experienced palpitations and insomnia. The physician's diagnosis was anxiety. The patient also experienced dermatitis, seborrheic keratosis, and a nevus. 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 are not listed as adverse events. Concurrent medications included omeprazole, lansoprazole, esomeprazole, pravastatin, paroxetine, citalopram, diazepam, alprazolam, zolpidem, buspirone, saw palmetto, sildenafil, ipratropium nasal spray, mometasone, budesonide, loratadine/pseudoehpedrine, desloratadine, oetirizine, and guaifenesin. The patient received his first injection of LYMErix on 6/1/99. He was seen by his physician for physical examination on 6/28/99. At that time, he reported numbness of his hands in the morning. The physician's impression was degenerative joint disease with hand numbness. The patient was instructed to exercise and stretch his hands and wear wrist splints at night. During that office visit, the patient received his second injection of LYMErix. At some later, unspecified date, the patient began to experience arthralgia and numbness of both hands. Early carpal tunnel syndrome was suspected and EMG tests were performed; the results were interpreted as normal. The patient then contacted VAERS to report the event and referred to a physician at a tertiary care center. On 9/15/99, the patient reported to his primary physician that the consultant stated, there was a 1 in 15 chance of the patient having a reaction to the Lyme vaccine. The consultant prescribed rofecoxib. Prior to this, the patient had self-medicated with ibuprofen. The patient was seen by his primary physician on 1/10/00; at that time, he reported experiencing arthralgia and numbness of his hands for one month. The physician's impression was probably carpal tunnel syndrome and the physician prescribed pyridoxine and wrist splints to be worn at night. On 7/7/00, the  patient had a routine physical and was given an injection of tetanus and diphtheria toxoids absorbed. On 7/10/00, total Lyme antibody titer was equivocal; Lyme IgG and IgM Western blots were negative. Please see Lab Data Section. Erythrocyte sedimentation rate was within the reference range. A streptozyme screen was positive. According to a VAERS form completed by the vaccine provider on 8/14/00, the patient complained of arthralgia unknown length of time. Pre-existing conditions included arthralgia and chest discomfort; concurrent medications included lansoprazole. The VAERS form also indicated that the patient had no illness at the time of vaccination The patient was seen again by his primary physician on 9/15/00. The arthralgia and numbness of his hands persisted, and had extended to involve his shoulders. He had not been feeling well overall. The patient reported that his symptoms had begun after receiving LYMErix. He reported that a hot tub had been helpful in controlling his symptoms. He continued to take both Vioxx and Motrin. No swelling, stiffness, or limited range of motion was noted on physical examination. The physician's assessment was recorded as Vaccination Complications Reaction (allergic) 999.5, Anxiety Generalized 300.02, Numbness 782.0, Arthralgia Hand 719.44, Arthralgia Shoulder Region 719/41, Allergic Rhinitis Due to Pollen 477.0. On 10/24/00, serology for hepatitis B core antibody was positive. Serology for babesiosis was negative. Serology for Lyme disease was equivocal. Please see Lab Data section. Lyme serology continued to be equivocal in February 2001. The patient was seen by his primary physician on 4/24/01 with chief complaints of heartburn over several years, sinus draining. No mention of joint pain or swelling, numbness, or fatigue was recorded. The patient was seen by his primary physician for an annual physical examination on 7/19/01; he has felt well with no specific complaints. The patient exercises five times per week. His exercise routine involves golf, treadmill and stretches. On examination of the extremities, there is no apparent pain with range of motion....There is no apparent disturbance of sensation. The patient was seen by his primary physician on 8/30/01 with a chief complaint of increase in anxiety. On examination, "He appears well....there is no gross abnormality noted on his exam. On 10/25/01, a variety of serologies for Lyme disease showed "No evidence of seroreactivity beyond that expected from the Lyme vaccine. He presented to his primary physician on 12/12/01 with complaints of abdominal pain, anxiety and insomnia. He overall feels quite well. No joint pain or swelling, numbness, or fatigue was noted. The physician's diagnosis was generalized anxiety. Pharmacy records indicated that the physician prescribed paracetamol with codeine. On 2/11/02, in a Statement of Injuries, the vaccinee's attorney alleged that he vaccinee has suffered from debilitating joint pain and swelling in both wrists, hands and shoulders. In addition, he suffers from fatigue and malaise. Outcomes of the alleged events were not specified. The patient returned to his primary physician on 11/18/02 with a complaint of pain in his left shoulder and left side of his neck which seems to radiate down the left side. On physical examination, the physician observed no joint swelling or evidence of acute inflammation noted, however he does have tenderness on palpation of his left shoulder more in the posterior aspect and lower shoulder blade region. He also has pain with abduction of his arm beyond 90 degrees. His neck is supple but he does complain of some tenderness on palpation of the posterior cervical vertebra and rotation of his neck toward the right is uncomfortable. The physician made a diagnosis of Arthralgia Shoulder Region and ordered x-rays. The x-rays revealed degenerative disease of the cervical spine; please see Lab Data Section. The physican referred the patient to a physical therapist. The patient returned to his primary physician on 2/4/03. He reported that Physical therapy was helpful somewhat in relieving his symptoms but he continues to have some pain, and is particularly concerned about numbness in his fingers bilaterally. On physical examination, the physician noted tenderness on palpation of posterior cervical vertebrae. The physician also noted that the patient still has some stiffness in his neck and paresthesias in his hands, especially with activity. The physician made a diagnosis of Spondylosis Cervical, with Myelopathy. He prescribed dextropropoxyphene napsylate with paracetamol and referred the patient to his neurosurgeon. On 5/5/03, the physician noted, "Overall (the patient) is doing well." The most recent information received on 6/23/03, provided diagnosis of cervical arthritis and myelopathy as the reason for the numbness and the debilitating shoulder pain. As a result, this report has been reclassified as serious, unexpected. As of 2/4/03, the neck pain, shoulder pain, and hand numbness persisted. The patient was doing well overall on 5/5/03. Information received on 23Jun03 provided diagnoses of cervical arthritis and myelopathy as the reason for the numbness and the debilitating shoulder pain. As a result, this report has been reclassified as serious, unexpected. The most recent information received on 01Oct03 indicated that the cervical arthritis persisted as of 28Aug03. The outcomes of the other reported events were not provided. Medical records received 25Aug04 indicated that the pt was seen by his primary care physician on 08Sept03 and complained of worsening neck and right posterior shoulder pain and stiffness. He was referred to a neurosurgeon. On 24Nov03, he saw a neurosurgeon who commented four years ago, he fell about five feet into a dumpster while at work, landing on top of this head. He felt a pop in his neck at that time and had pain in his neck for several days. Since that time he has had stiffness of his neck. The impression of the neurosurgeon was that the pt's neck and radicular pain were secondary to cervical spondylosis, primarily at the c5-6 level. A course of cervical traction at home was recommended. At subsequent follow up visits with his primary care physician on 01apr04 and 01July04, the pt was said to be doing well and had no complaints.