This report describes Lyme disease in a 42 y.o. male who received Lyme vax recombinant OspA (LYMErix). This report was received as part of litigation proceedings, w/forwarding of medical records. The medical history included severe low back pain (93), fibromyalgia, joint pain (lower extremities) (97), plantar fascitis, nonunited ossification center of the lateral malleolus (95), ankle surgery to remove a benign bone growth (97), knee pain, arthroscopy of the right knee w/menisectomy (98), torn medial meniscus, numbness of right ankle w/feeling of "paralysis", localized chest pain and left arm pain (Aug. 99) (chest pain was present for at least 6 mts) and he developed a severe rapid heart rate and was admitted. His internal medicine MD reported that his base line Cholesterol had been normal. Concurrent conditions included alpresolam (Xanax). Family history included both parents alive and well, w/coronary artery disease, but normal lipids. PT's social history reported "no tobacco or alcohol use". In a Statement of Injuries, his attorney alleged that the vaccinee "suffers from joint pain, specifically he experiences pain in his hands, knees, legs, back, feet. In addition he experiences flu-like Sx's, fatigue, excessive sweating and elevated cholesterol levels. He particularly experiences flu-like SXs following any type of exertion. He also suffers recurring sore throats and fever. In addition, he experiences disorientation and ringing in his ears." Time to onset following immunization and outcomes of the alleged events were not reported. On 8/7/99, the vaccinee was seen in the ER. He had experienced intermittent precardial chest discomfort "for some time". More recently, it has accelerated in frequency and has been associated w/some early... episodes of sensation of palpitations and tachycardia. Additionally he had numbness in his left arm, and indigestion after riding his bike. His chest pain was worse after exertion. He had cold sweats and night sweats. Final Dx: Non-cardiac chest pain; history of palpitations. The vaccinee infections of LYMErix on 9/1/99 and in 10/99. In Nov. 99, the PT experienced injury ("possibly due to running 5 miles daily") and was Dx'd with left plantar fascitis. On 12/21/99, an x-ray revealed a "normal left foot." On the initial physical therapy and sports medicine evaluation on 2/11/00, the PT reported having decreased pain and improved ankle range of motion following therapeutic exercises. Assessment: range of motion and strength had improved. On 2/11/00, the vaccinee was seen by the MD. His chief complaint was left arch pain. He states that the problem started fairly suddenly 3 months ago and has not gotten any better though he has stopped running. Previously, he had been running 5 miles daily. He thinks that 2 factors might have contributed to the problem. One was a motor vehicle accident 3 days before his left foot started hurting where he did feel like he jammed the left foot in the floor wall of the car. He did not recall any swelling or bruising in the area. He was also started on fluvastatin sodium (Lescol) for high cholesterol. He had significant increases in his muscle enzymes, and this also corresponded to the time frame when his foot started to bother him. Concurrently, he has both post static dyskinesia SXs as well as increased pain with activity. He also has a contributory history of left ankle surgery to remove a benign bone growth 3 yrs ago. He does have occasional angina and high cholesterol. He was currently taking colestipol hydrochloride [Colestid] and he has the stated allergy to Lescol. The PT has been for x-rays on 12/21/99 which showed no fracture of dislocation or other bony abnormality w/a normal left foot study noted. He also went for a bone scan on 1/2/00. The report showed "a normal 3-phase scan of both ankles and feet w/no abnormal activity seen." Assessment: probable planter fascitis of the left foot. Physical therapy and rofecoxib (Vioxx) were prescribed. On 3/5/00 magnetic resonance imaging revealed a "normal MRI of the left foot." On 5/19/00, the alanine transferase serum concentration was 57 U/L (30-65); the aspartate transaminase serum concentration was 29 U/L (15-37). On 7/8/00, the erythrocyte sedimentation rate was 12 mm/hr (0-15); the alkaline phosphatase serum concentration was 171 U/L (50-116). The Western Blot was negative (IgG bands 41, 31 kD were present; IgM bands 41, 23 kD were present). The Lyme disease antibody screen index was 1.56 ELISA units (less than or = 0.80). Antinuclear antibody titer was less than 1:40 (less than 1:40 negative). On 6/16/00, the vaccinee was seen by the MD in order to have his orthotics dispensed. The PT stated that he was doing "reasonably well" w/regards to the left arch pain. He did want to discuss a problem that he has had since about the age of 25, however. He stated that w/stressful activities to the front of the ankle, such as kicking a football or a soccer ball, or w/a lot of running, he will have complete numbness of the right ankle, lower leg, and top of the right foot, and even a feeling of "paralysis" that will last for about 2 hrs. When he started running again a few wks ago, he stated he was still getting this problem. It will also be accompanied by soreness afterwards for approximately 2 hrs. Assessment: improving plantar fascitis, left foot. In regards to the right foot, it appeared that he may be getting an exertional tendonitis of the extensor digitorum longus and extensor hallucis lungus, though there could also be an entrapment neuropathy of the deep peroneal nerve and even a more remote possibility of this being an exertional compartment syndrome. However, w/the long-lasting problem, "I am more concerned at this point than he may be experiencing an entrapment neuropathy of the deep peroneal nerve," Plan: "since this has been an ongoing prob for more than 15 yrs, though on an intermittent basis depending on activity, I have recommended that we get a baseline electromyography nerve conduction study test... It should be noted that the PT was comfortable during an in-office trial w/the orthotica." The vaccinee remained under the care of internal medicine MD from 7/7/00 until at least 6/20/02. The following signs/SXs were reported on the progress note on 7/7/00 under the physical findings: tinnitus, shin pain, excessive perspiration, fatigue, weight gain, night sweats, knee pain (greater in right than left), wrist and hand achiness, foggy, "word find", stuttering, "ambulating", unexplained fevers. The number one complaint of vaccinee was noted as increased cholesterol; and number two complaint was SXs of Lyme w/notation of increased joint pain (lower extremities) for 3 yrs and fatigue. At the time, the vaccinee listed the following SXs from Lyme Disease checklist: tick bite; joint/muscle pain in feet; ankle pain; burning in feet; shin splints; unexplained fevers, sweats, chills; unexplained weight change; fatigue, tiredness; lessitude; swollen glands; sore throat; change in bowel function (taking Colestid), chest pain or rib soreness; SOB, cough, asthma flare-up; heart palpitations, pulse skips, heart block, joint pain or swelling, stiffness of the joints, neck or back; muscle pain or cramps; tingling, numbness, burning or stabbing sensation; ears / heating, buzzing, ringing, ear pain; confusion, difficulty in thinking, concentration, reading, forgetfulness, poor short term memory, disorientation, getting lost, going to wrong places, difficulty w/speech, enunciation; mood swings, irritability (can be explosive), depression, anxiety; disturbed sleep, too much, too little, early / frequent awakening; excessive clumsiness (hand, finger only); recurrent URI's; personality changes (emotionally labile, volcamic rages, low frustration levels); transient muscle pain that travels around the body. On an unspec'd date the MD's progress note indicated that after the vax received LYMErix vax's he developed "generalized fatigue and exercise induced viral-like cold SXs, w/a stuffy note, sneezing and cough. The MD reported that he further developed: increasing knee pain (right greater than left), night sweats, excessive perspiration, shin pain, tinnitus, hand achiness, right foot weakness, profound fatigue, fogginess, difficulty w/word finding, irritability and difficulty w/stuttering. The MD reported that the PT lives in a Lyme endemic area. The PT's dog had Lyme disease and his entire neighborhood had Lyme disease. The PT had tick bites, but does not retain any rash at the site of any bites. In addition, the MD reported that the vax had period paraesthesias, which had disappeared spontaneously and the PT had developed exercise induced asthma. He also experienced intermittent night sweats, had felt febrile that was followed by extreme fatigue, difficulty w/getting lost and some disorientation. Overall the vaccinee had just not been feeling well. Upon physical exam the MD noted: neurologic: nonfocal, except for some decreased strength on dorsiflexion of the right foot. Action plan was noted probably Lyme disease, status post LYMErix vax. The Plan included: Lyme ELISA, western blot, Ehrlichia and Babesia titers, ANA titer, rheumatoid factor, CPK, aldolase, CBC, metabolic profile, thyroid panel ordered. The PT will return in a 1-month period of time. Call w/any interval prob's." On 8/11/00, the PT had a follow-up of Lyme disease, status post LYMErix vax. The PT had started Biaxin and doing well. W/in 1 wk to 10 days, he had relief of his plantar fascitis, knee pain and shin splints. He had noticed an increase in his tinnitus, headaches, and spatial disorientation. His energy level remained poor and large muscle groups remained achy. He had no recurrent arrhythmias. He had still remained quite foggy, w/difficulty w/word finding and stuttering. Lab Data indicated that Lyme ELISA was positive, western blot w/2 bands. Action: noted "Lyme diseased". Plan was to continue biaxin. On 10/6/00 the visit was in follow-up of seropositive Lyme disease. The PT had continued headaches w/frequency of 1-3 days, bi-temporal, and always associated w/spatial disorientation, decreased stuttering, fogginess, significant cramping when walking, cramping calves, excessive fatigue and excessive perspiration. The vaccinee's sleep patterns had been disrupted significantly and he continued w/increase in tinnitus. The PT was still on biaxin that helped w/aches and pains. Action indicated: "seropositive Lyme disease". The plan noted, "at this point, will continue present management w/biaxin for another 6 wks; he has been on it for a total of about 3 mts at this point". The MD indicated that his plantar fascitis was better and his shin splints had improved. On Nov. 00 the MD's progress note indicated joint pains resolved 80%. The MD reported that the vaccinee currently was having backaches, disorientation, increased ringing in his ears, leg muscle groups tire easily, increased sweats at any time, out-of-breathe with simple activity, sharp pinpoint right calf, left groin area pull, spatial, shin splint and unspec'd knee problem. On 11/15/00 follow-up visit of hyperlipidemia and seropositive Lyme disease it was noted: headaches have lessened, energy level better, mental clarity better, sleeping better, now w/severe pain in and about right knee, also radiating down into the tibia and calf, had profuse night sweats along with severe timidness. Action noted: 1) Lyme arthralgia - seropositive; Lyme vax continue biaxin and bicillin, recent labs one month prior were stable. The MD had planned to get an x-ray of the knee. On 11/17/00 progress note, the MD reported: headache, fatigue and sleep had improved; however, ringing in ears, right leg pain in calf and knee and sweating had not improved. The MD noted: negative for fever, chills, and diarrhea. X-ray of right knee was interpreted as normal. (Please see Lab Data section.) On 1/5/01 the MD reported that the visit was for follow-up evaluation of Lyme disease. According to the MD< Lyme disease was improving and following conditions had improved: headaches, increased energy level, mental clarity, sleeping and night sweats. At this time, the PT was negative for fever or chills and there was no improvement in his tinnitus and his right knee was still somewhat unstable and achy and continued tendinitis. Assessment noted: "Lyme disease, improving, continue present therapy. Vaccinee was still on bicillin and biaxin LA. Will check routine liver enzymes along with a CBC and cholesterol". On 2/21/01 visit, his headaches, fatigue, night sweats, mental clarify, sleeping and irritability had improved. The MD reported that the vaccinee was still w/tinnitus, SOB w/minimal exertion, lack of energy, severe right knee pain and headache. At the visit, the vaccinee had been off Sicillin for 3 wks. The plan was to "continue bicillin for another 1.5 mts and then discontinue." On 3/6/01 progress note, the MD indicated fatigue, muscle pain and chill. The follow-up for Lyme disease on 4/4/01 noted "feeling swings" [feeling good - feeling bad]. The following conditions were noted: increased tinnitus, flu/fatigue, achiness, knee and ankle pain, chest wall pain, insomnia, night sweats, decreased mental clarity and chills. The MD reported that "all of these SXs seem similar to what he had early on". The assessment noted "Lyme disease, not responding to bicillin. Will discontinue bicillin, PCR testing in order. Follow-up contingent on his PCR's." At that time the results of the Lyme test were interpreted as "abnormal". (Please see Lab Data section). On 5/21/01 the visit was for re-evaluation. The following conditions had improved: tinnitus chest wall pain; headaches, night sweats, chills, and brain fog. The following conditions had not improved: sore throat (his son had a sore throat), right knee and calf pain, occasional sleep difficulties, occasional mental clarity prob's, and increase in thirst. The vaccinee also c/o'd sinus congestion. The MD's physical exam at that time included pharyngitis w/some mandibular adenopathy. The vaccinee had been off bicillin for about 6 wks at this time. The assessment noted: "he had a pharyngitis compatible w/strep. MD prescribed amoxicillin (amoxyl). He will have repeat lipid panel check in view of his hyperlipidemia." The 7/23/01 visited noted: "follow-up Lyme and discuss labs". The 10/16/01 follow-up for Lyme disease reported vax complained of knee pain, tinnitus, tired, flu-like SXs. The MD noted that all of the latter SXs "goes in cycle - getting further apart". He was on no medication at this time. 11/15/01 visited noted the following SXs: brain fog, lower leg pain (shins, ankle, leg), tinnitus, fatigue, unable to exercise, myalgia, and arthralgia. The MD reported that the latter conditions worsened with weather change. The vaccinee also had sinus congestion, postnasal drip, nonproductive cough, chills and fever. The physical exam revealed: "right normal and left blocked with cerumen and right tenderness distal tibia, medial and lateral". Action noted: "Lyme Elisa/Western blot on 10/17/01, results" to another MD. (Please see Lab Data section). Plan included: "PCR testing and doxycycline for 1 month". On 12/6/01 the MD had noted that he telephoned vaccinee with positive PCR for Lyme. (Please see Lab Data section). The follow-up visit for Lyme on 12/14/01 noted that the PT complained of disorientation, fatigue, tendinitis, shin splints, leg cramping, myalgias, arthralgias, tinnitus, and leg pain (lower extremities). The MD had reported that "his recent testing showed positive western block compatible w/yeast infection". A MRI of his brain was planned at this visit. The history of the MRI order sheet noted: "history, negative for surgery, Lyme disease for 2 yrs with disorientation, and negative numbness". The results of magnetic resonance imaging (MRI) of the brain, performed on 12/17/01 were interpreted as normal. (Please see Lab Data sheet). On 1/9/02, the MD noted: "vaccinee presented for follow-up of Lyme. Overall, the PT stated that things had improved slightly. PT felt that he was "approx 60% of where he wants to be". PT had SXs of feeling "foggy", fatigue, tinnitus, myalgias, arthralgias, and difficulty sleeping. He was negative for: leg pain, SOB, headache, difficulty concentrating, night-time diaphoresis, change in bowel movement or abdominal pain. Physical exam indicated "bilateral tymphanic membrane cerumenous, nasal mucosa, and cranial nerves II and XII were grossly intact". The action plan indicated that Lyme had "improved, but not resolved, and intravenous versus oral therapy was noted". Doxycycline was discontinued last week. On 1/22/02, the MD noted: "midline 1/14/02, removed 1/15/02, secondary to thrombophlebitis (left arm), redness resolved and had some tenderness to medial epicondyle, no swelling or lumpiness. The MD reported that a 2nd midline was inserted 1/22/02 in the right arm. At this visit vaccinee had completed one week of Rocephin. The vaccinee's fatigue, sleeping, muscle aches, joint aches had improved, but his headaches worsened and Motrin had helped. The MD's action just noted "Lyme". Plan included: Ibuprofen, "no workout, may walk dog." At this visit there were negative findings for: chills, fever, rashes, right upper quadrant tenderness or gastrointestinal upset. On 1/11/02, the vaccinee's visit was noted to complaint of pain at site of "midline removed from right arm". He was "concerned about blood clots". According to MD, the "midline right arm was removed on 1/30/02 2ndary to swelling and unable to straighten arm". The MD reported that the swelling had decreased and able to move arm back. He had been using nonsteroidal anti-inflammatory drugs (NSAIDS) and warm compresses. He felt that ibuprofen was causing urinary frequency and urgency. The physical exam indicated that the right arm was positive for tenderness in the antecubital area, no tortuous vein, no redness, minimal swelling and able to fully extend right arm w/minimum guarding. Action indicated removal midline and right arm swelling. The plan noted: "continue warm compressed and ultrasound right/left arm for pain to rule out deep vein thrombosis. Imaging and doppler of the arms performed at that time were interpreted as normal" (Please see Lab Data section). On 2/7/02, the PT's follow-up for Lyme indicated that the ankle swelling and brain fog had improved. At that time, the vaccinee was positive for fatigue, some brain fog, and bruising to antecubital left arm which was a new onset. The MD noted that PT was sensitive to IV material (silicone) and this produced a streaking immediately after placement. There was an initial lump after line insertion, now gone. The vaccinee had no breathing difficulties, no epigastric pain, but diarrhea had occurred 2 days ago. Tinnitus was reported as worse, and headache protocol was noted. Action plan indicated "Lyme". The plan was to "continue treatment and lab slip for Clostridium difficile if diarrhea continued and after Tx discontinue". The MD noted: "left antacubital median noted ecchymosis which was yellow w/no warmth, or distention to vessels". The visit on 2/27/02 indicated that the vaccinee was still w/fatigue, hypersomnia, right knee pain, congested sinuses and knee tenderness. In addition, the following SXs were reported: Increased tinnitus, sinus congestion, tired and right knee pain. At this time, the vaccinee had been off Rocephin for 2 wks. The physical exam noted: "significant for bilateral Shulman impaction". The assessment reported "Lyme disease, adequate Tx, no further intervention necessary. The Shulman impaction will use hydrogen peroxide (Debrox) drops and Ginkgo has been prescribed for his tenderness". The follow-up visit on 4/18/02 for Lyme noted: "feeling better, cycles of 6 wks - last 1 week". The vaccinee had lasix surgery, double vision and pain in right eye. The MD reported that the latter was "quite unusual, happens 1 in 100 times". The MD further indicated "no specific complaints, except for some clear mucosa drainage from his right naris every morning. The vaccinee was off Rocephin and he had not been able to use Debrox because he felt it was "getting into his taste buds". The physical exam revealed: bilateral "seroma" impaction. The Plan indicated "try desloratadine (Clarinex)". The follow-up visit of 6/20/02 for Lyme noted "70% better", complained of knee pain, twinges in arch, pain in the arch of his left foot, and arthralgias. The assessment noted "post lyme syndrome w/arthralgias: continue symptomatic Tx. Hyperlipidemia: continue colesevelam HC1 (Welchol). Check lipid panel." In addition the MD provided a medication list that included Niachol. On 7/14/00, the vaccinee was seen by the MD. The medical record noted that the vaccinee was Dx'd w/Lyme disease and has had 2 days of chills, fever, sore throat, and exercise-induced myalgia. He was started on 2 unspec'd oral antibiotics on 7/13/00. He had no c/o's left foot pain. On 10/10/00, the erythrocyte sedimentation rate was 7 mm/hr (0-15); the cholesterol level was 241 mg/dL (100-200); the alkaline phosphotase serum concentration was 153 U/L (50-136). On 10/13/00 the vaccinee was seen by the MD and assessed w/posterior tibia tendonitis. On 2/6/01 the Lyme Western Blot was negative (IgG bands 41, 31 kD were present, IgM band 41 kD was present). On 2/6/01, babesiosis antibody IgG titer was less than 16 (less than 16: Babesiosis antibody IgM titer was less than 20 (less than 20). On 2/6/01, the cholesterol level was 256 mg/dL (100-200); the alkaline phosphatase serum concentration was 145 U/L (50-136). Lab analyses performed on 2/14/01 revealed E. chaffeensis antibody IgG less than 64 (less than 64); E. chaffeensis antibody IgM less than 20 (less than 20). On 7/13/01, the alkaline phosphatase serum concentration was 161 U/L (50/136); the aspartate transaminase serum concentration was 24 U/L (15-37) and the alanine transferase serum concentration was 41 U/L (15-37). On 2/6/02, the alkaline phosphatese serum concentration was 207 U/L (50-136), the aspartate transaminase serum concentration was 82 U/L (15-17) and the alanine transaminase serum concentration was 204 U/L (30-63). As of 5/14/02, the outcomes of the events were unknown. The adverse events, "joint pain" and "ringing in ears" do not meet ICH serious criteria, but are being submitted as an expedited report by special FDA request per the June 28, 00 letter. The most recent info, received 7/25/02, indicated that knee pain, twinges in arch, pain in the arch of his left foot, and arthralgias persisted as of 6/20/02 the outcome of the other events was not provided.