Age: 44.0
Sex: M
Vaccine: LYME
Symptoms: Muscular weakness, Pain, Polyp, Retching, Speech disorder
Clinical narrative: The report describes "atypical" amyotrophic lateral sclerosis (ALS) in a 44 year old male who received Lyme disease vaccine. The pt was seen by a neurologist on 10/29/99. At that time, the pt reported "abnormal speech and swallowing for about 6 months." He reported that he felt as though he was choking, although he had not actually aspirated. He also reported "a somewhat vague slurring of speech" and "occasional  fasciculations in his arm muscles". At the time of the neurology consultation, the pt was a construction worker and was "still able to do physical work without any difficulty." On physical exam, eye closure was noted to be "slightly weak bilaterally. The pt was unable to bury his eyelashes on either side and the eye could be pried open relatively easily." The physician noted possible tongue fasciculations without scalloping of the tongue border. Results of nerve conduction studies and EMG performed on 11/24/99, were "consistent with a dx of motor neuron disease." The neurologist stated, "this is probably ALS". The pt went hunting and developed cellulitis on his hand. He was seen by his PMD on 12/8/99 and reported sustaining a tick bite on his hand. The physician's impression was "cellulitis-resolved". A Lyme antibody titer measured on 12/14/99 was positive at 1.81. The pt was referred to an infectious disease specialist, who saw the pt on 1/28/00. The chief complaint noted was progressive twitching. The pt reported that he could no swallow liquids, but could swallow food. The pt also reported slurred speech. On physical exam, the physician noted twitching. The pt was treated with Rocephin. The pt was seen by the infectious disease specialist on 2/11/00; he reported that he could swallow water "well" and was twitching "on and off". The pt developed hives. On 2/18/00, Rocephin was discontinued and treated with Medrol Dosepak. On 2/22/00, the pt reported his swallowing was nml. On exam, the physician noted "rare" fasciculations of the upper arm with normal arm strength and his speech was still slurred. Before the study, the physician noted dysarthritic speech and "muscle fasiculations seen throughout, including tongue fasciculations." The pt saw a rheumatologist on 3/3/00, mostly for question of a dx of Lyme disease. At that time, the pt denied having any tick bites. The physician noted that the pt had been "dramatically better neurologically" one the 1st day of receiving IV Rocephin. The physician stated "his positive ELISA is likely related to vax. On 3/16/00, the pt was seen by a neurologist specializing in neuromuscular disease. This physician noted that the pt's first symptoms began in 8/99, "when he began to gag when he was brushing his teeth. Shortly thereafter, he began to develop twitches in his left arm." On exam, the physician noted "bilateral tongue and facial weakness with tongue fasciculations. He has fasciculations in all 4 extremities more so in the arms. Reflexes are pathologically brisk." The physician stated, I am afraid that the dx of ALS is inescapable." The pt saw another neurologist on 3/21/00 and he noted the pt "developed mild dysarthria in 9/99." He also noted that the pt received Lymerix in 9/99 and 10/99 (exact dates were not reported). It was not stated whether the mild dysarthria began before or after Lymerix. The neurologist stated, "He appears to have primary motor neuron disease, probably ALS. I do not feel that the Lyme vax is specifically related to these symptoms since these began in 8/99, before the vax." The pt was seen by another physician on 4/7/00. At that time, the pt reported that 1 week, post vax, of 2nd Lymerix, he experienced "trouble getting words out." The pt reported that his primary physician said the pt was "under stress" and prescribed Zoloft. On 4/10/00, the pt was seen by a neurologist specializing in ALS; noted "excessive laughing and crying" over the previous 3 months. From his exam, he believes the pt has fairly early bulbar-onset ALS. On 9/8/00, the pt saw another neurologist. Atrophy of the tongue, a forearm and thumb of left hand was noted. Jaw reflexes showed some clonus and upper extremities had spread, spastic catch, and bilateral Hoffman reflexes (4+). The neurologists dx was "amyotrophic lateral sclerosis with bulbar involvement. The pt was seen by this physician again on 10/00 and noted that the infectious disease specialist was treating the pt for Lyme disease with a 28 day course of IV Primaxin IV. The pt had been treated with Rilutek but stopped therapy prior to 10/10/00 because of "additional muscle twitching". The pt was asked to continue Rilutek. On 2/15/01, the pt's attorney reported that the pt had been "dx'd with an atypical ALS, triggered by vaccination." However, the medical records supplied by the attorney did not indicate such a dx. The attorney stated that it is currently unclear whether the ALS was caused by Lymerix; the pt was predisposed to develop ALS and the immunization triggered it, or the ALS was accelerated by IZ. The most recent information, received on December 5, 2001 did nor provide the outcome of the ALS. On 02/11/2002, in a statement of injuries, the vaccinee's attorney alleged that the vaccinee has experienced slurred speech, muscle twitching, weakness in his arms and pain at different points in his legs. The most recent info received on 02/11/2002 did not provide the outcome of the ALS. ALS is considered medically serious. The most recent information, received in 05/14/2002 incidated that the vaccines was becoming weaker on 08/09/2001. On 29 march 2001, the vaccinee was seen by a physician specializing in physical medicine and rehabilitation of muscular dystrophy. Medications at the time included Rilutek 50mg twice daily and zoloft 100 mg. The physician noted that "He has not been losing weight but is developing atrophy of the upper extremities. The patient is essentially averbal and eats foods of all consistencies but thin liquids appear to pool in the valleculae. He had stridor during VC (vital capacity) maneuver and no PCF." Manual muscle testing revealed shoulder strenght to be 3/5 bilaterally. Biceps strength was 4-/5 bilaterally, and wrist strenght was 3-/5 bilaterally. All other muscle groups were 5/5. Oxygen saturation ranged from 93 to 95. The physician's assessment was "the patient has bulbar ALS". His mild desaturation prior to cough maneuvers and clear symptoms of faucial pooling bear witness to chronic aspiration. Plan: the patient was counseled to cough whenever the Sa02 (oxygen saturation) decreases below 95%. A western blot performed on serum on 05/15/00 revealed a positive Lyme IgG (bands 93, 58, 45, 41, 39, 30, 28, 23, 18 present) and a positive Lyme IgM (bands 41, 39, 23 present). On 06/26/00, hte pt underwent a speech and swallowing evaluation. "The pt continues to present with mild oral dysphagia for solids and mild dysarthria. Swallowing difficulties were noted in all three phases of the swallow. Dysathria was characterized by mild slurring, reduced rate of speech, and mild distortions of lingua-alveolar and sibilant sounds. Vocal quality was judged to be mildly hypernasal with mildly reduced intensity and monotone pitch." Recommendations included a regular diet with thin liuids with strict adherence to aspiration precautions. Laboratory evaluation on 07/13/00 revealed a sedimentation rate of 3mm/mr. On 07/13/00 western blot performed on serum revealed a positive Lyme IgG (bands 93, 58, 45, 41, 39, 30, 28, 23 and 18 present) and a positive lyme IgM (bands 41, 39 and 23 present). lab evaluation on 08/19/00 revealed a positive hepaitits A virus Ab. Immunoglobulin M 218 and alkaline phosphatase 32. On 08/23/00, a thyroid scan revealed no significant findings and the thyroid uptake was 9.5% (reference range 6.0%-16.0%). The vaccinee was seen by another physician on 10/30/01 who noted that the vaccinee had spastic ALS with difficult swallowing, "twitching" muscles, "grossly adversely affected" speech and intact mentation. There is a possibility the vaccinee had chronic Lyme disease as evidenced by a positive western blot. The vaccinee was markedly debilitated. Plan of teatment included hormonal studies, vitamin C infusions and gluthathione. The vaccinee was advised to eat a high protein diet with steamed vegetables." On 11/03/01, the vaccinee had a "toxic element clearance profile" performed. This revealed lead 16.78me; 24hr (reference range <=9.30), arsenic 144.9meq/24hr (reference range ,=61.8), chromium 201.62 meq/24hr (reference range 16.27-108.44), copper 57.63meq/24 hr (reference range 1.34-54.62), manganese 4.760 meq/24 hr (reference range 0.072-1.233), nickel 8.45 meq/24 hr (reference range <=3.23), tin 32.35 meq/24 hr (,=6.18), titanium 477.7 meq/24 hr (reference range <=332.4) and tungsten 1.502 meq/ 24hr (<=0.997). This physician also indicated the test revealed some heavy metal toxicity.  Medical records from the same physician indicated that on 11/08/01 the vaccinee was receiving electromagnetic therapy. After the first treatment, the pt reported his shaking was reduced and he felt better. Medical records indicated that on 01/03/02 the vaccinee was prescribed prednisone for a "bad rash." The most recent info, received 06/12/02, indicated that the vaccinee was feeling significantly better with better physical activity on 11/08/01. On 11 February 2002, in a Statement of Injuries, the vaccinee's attorney alleged that the vaccinee "has experienced slurred speech and gagging, as well as muscle twitching, weakness in his arms and pain at different points in his legs." Following the reported onset of ALS, the vaccinee experienced hypocholesterolemia, increased concetrations of aspartate aminotransferase and alanine aminotransferase, and a "bad rash" treated with prednisone. These events were not reported as adverse events due to vaccine administration, but were found during the course of review of the vaccinee's medical records. Therefore, they are not listed as adverse events. The most recent information, received on 03 October 2002, did not provide the outcome of the reported events. Information received on 12 June 2002 indicated that the vaccinee was feeling "significantly better" with "better physical activity" on 08 November 2001. ALS is considered manufacturer medically serious (OMIC).