In 2001, the pt received his 1st and 2nd injections of Lymerix. "Since then", he has experienced prolonged fatigue, "a number of allergies", "generalized allergic predisposition", chronic prostatitis and colitis. Treatment and outcome of the events were not provided. The physician considered the events to be possibly related to Lymerix administration. Colitis is considered to be "Medically Serious". The follow up states the pt's age as 52 years old. The medical history also included hypercholesterolemia treated with Zocor. The vaccinee had no adverse experience following previous immunizations. In April 2001, he experienced diarrhea and abdominal pain. In October 2001, he experienced urticaria, bronchospasm, and chest pain. In February 2002, he experienced dysuria and urinary frequency. The LYMErix immunizaiton series was discontinued. The most recent info was received on 4/29/02. The physician stated that as of 4/15/92, the molitis had improved; the chronic urostatitis, allerties, and "generalized allergic predisposition" were unresolved. The physician considered the events to be serious because they jeopardized the pt or required intervention to preventt a serious outcome. The follow up states on 1/2/03, a second attorney alleged that the vaccinee received two injections of LYMErix in August 2000; exact dates were not provided. The attorney alleged that the subject "declined the third and final vaccination due to the severe fatigue and increased sensitivity to cold that he was experiencing. Thereafter, he experienced severe fatigue, protracted diarrhea, severe allergic reactions, encephalopathy in the rigth leg, acute prostatitis and protracted pain. As such, he was been left to suffer with what has thus far been incurable and at times dehibilitating pain which severely limited his employment options and opportunities." The following information was received from medical records. The subject presented to the vaccine provider on 12/21/00 with a complaint of persistent fatigue since receiving two Lyme vaccinations this past summer. He additionally has had intermittent twinges of right mid chest discomfort for the past several months. A recent stress echo was unrevealing. Patient's last complaint is a sense of altered smell since having an upper respiratory tract infection in October. This altered sense of smell was persistent for one weeks time and since has been intermittent, occurring three to four times weekly. He describes his altered sense of smell as being a generalized foul smell. Medications at that time included simvastatin. Physical examination revealed focal tenderness over the right mid anterior chest just at the costochondral junction of the sixth rib. The physician's impressions were: persistent fatigue, right anterior chest pain-questionable costonchondritis, altered sense of smell. The physician discontinued sinvastatin therapy. Lab analyses performed on 1/2/01 revealed abnormalities. Please see lab data dection. The subject remained under the care of the vaccine provider until at least 4/15/02. During this time, the subject reported persistent fatigue which now prevents him from exercising and frequently prompts him to take a nap in the afternoon, mild frontal headache, fleeting vertigo, intermittent testicular discomfort and a sense of fullness in his rectum, and mild dysuria. The subject underwent enteroscopy for evaluation of iron deficiency, positive gliadin antibody, and negative endomysial antibody on 3/19/01. The physicain's impressions were unremarkable proximal small bowel. Diffuse mild gastritis. Small hiatus hernia. The subject underwent colonoscopy for evaluation of iron deficiency and new onset diarrhea on 4/11/01. The physician's impression was probable mild left sided colitis (aphthae were more numerous and more proximal in location than one sometime scan see as a consequence of the bowel prep). other findings during this time included slightly boggy and tender prostate, palpable internal hemorrhoids, and slightly enlarged tender prostate. During this time, the physician noted he has additionally discontinued his Zocor without impact on his fatigue, his stamina has improved, he no longer requires afternoon nap and he is able to exercise on a regular basis and his chronic fatigue has resolved. On 9/17/01, the physician noted that the subject was seen by another physician, and prostatic massage confirmed the diagnosis of prostatitis. On 10/19/01, the subject reported that two days ago, he had an anaphylactic reaction to his allergy injections which required treatment with Benadryl and epinephrine. He was left with a sense of mild fatigue and chest discomfort when he takes a deep breath. The physician made additional diagnosis of chronic fatigue-questionably related to Lyme vaccination, mild headache, fleeting vertigo and intermittent alteration of smell, inflammatory bowel disease with left-sided ulcerative colitis versus granulomatous colitis, iron deficiency probably secondary to inflammatory bowel disease, possible prostatitis, quiescent left side colitis, prostatitis, symptomatic hemorrhoids, Anaphylactic reaction to allergy shot, and recent influenza. The physician prescribed resumption of simvastatin therapy, mesalamine, an iron supplement, and levofloxacin. The physician referred the subject to a neurologist, a colorectal surgeon, and an allergist. The subject was evaluated by the neurologist on 2/1/01. At that time, the subject reported that since September of the year 2000 has been overly fatigued, more with more difficulty in concentration, poor balance. He lost his balance a couple of times while going up stairs and sometime in October while at the airport he had a very foul smell which has not completely subsided. This happened after he had received two shots for vaccination for Lyme disease. The neurologist noted that the subject had ab out of transverse myelitis at the age of 21, his symptomatology lasted for about 30 days and he had a myelogram. On examination, he performs well on higher mental tasks. There was no symbolic language deficit....His neurological examination was nonfocal. My clinical impression is encephalopathy, etiology unclear. The neurologist prescribed modafinil. Serologies revealed elevated Epstein-Barr titers suggestive of an Epstein Barr virus infection at some undetermined time in the past and elevated gliadin IgG and IgA. Please see lab data section. The subject was evaluated by a colorectal surgeon on 2/1/02. He reported a four day history of anorectal pain. The pain started after he developed diarrhea following the cessation of his Asacol last week. He restarted the Asacol when he developed several loose, nonbloody bowel movements per day....The anorectal pain in constant and is exacerbated by sitting. He has had some night sweats but he denies any fever or drainage. On physical examination, the surgeon noted mild excoriations and inflammations in the left lateral quadrant 2cm from the anal verge. There is point tenderness at this location but no fluctuance or erythema. Digital rectal exam reveals no fluctuance or masses. There is no evidence of a fissure of fistula on today's examination. Under sterile condition, a needle aspiration was performed at the area of tenderness and there is no evidence of an abscess. The etiology of his anorectal pain is unclear but it might be related to an early abscess or possibly from the superficial ulceration of the anoderm. He is planning on traveling for the next several days so I prescribed Levaquin and Flagyl. I also advised warm baths and I prescribed a topical anesthetic cream. The subject was evaluated by an allergist on 4/8/02. At that time, the subject reported that he received his second injection of LYMErix in 9/00 and within 60 to 90 minutes he felt the abrupt onset of general malaise, heat, sweating and extreme fatigue. His chief complaint is persistence of these symptoms, with waxing and waning degrees, to the present....He has been on immunotherapy for years for allergic rhinitis and was on monthly maintenance doses but had a major anaphylactic reaction for the first time December 2001. One month later, he took Celebrex and within 1.5 hours also had an anaphylaction reaction also characterized by systemic urticaria and significant bronchospasm requiring emergency treatment. He had previously tolerated Celebrex although the last time was three to four months before. His review of systems has been notable for frequent episodes of sweats since September 2000 occurring approximately two to three times per week either during the day or nght often associated with a sense of warmth and flushing. His chief complaint has been constant extreme fatigue. He usually works 60 to 80 hours per week and went to the gym five out of seven days. His workout is now cut and he goes to a gym two out of seven days with 50% of his regular exercise regimen....At the time I saw him a detailed physical exam was completely unremarkable. IMPRESSION: I am not sure what has caused his varied symptoms all occurring since the second Lyme vaccine 9/00. There is no common immune mechanism to describe his problems since then. Remotely the colitis is autoimmune (antibody or T-cell mediated). The prostatitis and early abscess suggest decreased immune activity, if indeed they are related. His anaphylaxis to the immunotherapy is specifically IgE mediated whereas the reaction to the Celebrex is oversenstivity to increased production of leukotrienes with no specific immune mechanism involved. One remote theoretical possibility is that the second Lyme vaccine stimulated his antigen presenting cells which responded by acutely releasing cytokines including TNF and IL2. These certainly induce flu-like symptoms of fatigue and episodic sweats although these have decreased from the September 2000 onset. Cytokines from antigen presenting cells certainly have the capacity to trigger the rest of the immune system and remotely may have contributed to colitis, if it is immune mediated and possibly to this anaphylaxis. Association of the other problems becomes more remote. It is almost impossible to determine if this is the case, because of current limits of available tests. On 4/15/02 the vaccine provider wrote a medial summary for the subject. He wrote, The subject is a 51 year old gentleman who received the Lyme vaccination in August of 2000. After receiving the second in the series of three vaccinations, the patient developed severe fatigue and increased sensitivity to cold, prompting a decision not to administer the third and last in the series of three Lyme vaccinations. The patient's fatigue persisted throughout the remainder of the year 2000 and through 2001. It began dissipating earlier thisyear but has recently re-intensified. In addition, the patient developed several other problems subsequent to his Lyme vaccination. These problems include: protracted diarrhea which proved to be secondary to left sided colitis at colonoscopy in March of 2001 for which the patient was placed on Asacol in treatment....Severe allergic reactions (with bronchospasm, chest pain and diffuse urticaria) secondary to allergy injections and Ibuprofen and recently ketchup and salad dressing; Transient intermittent sense of foul smell and a sense of weakness in the right lef for which the patient was seen in a neurologic consultation and which was felt to be the consequence of encephalopathy of unclear etiology; acute prostatitis in January of 2002 with residual symptoms through this point in time; Recent bout of protracted anorectal pain for which he was seen by a colorectal surgeon and which was felt to be possibly secondary to an early abscess and for which he was placed on a course of Levaquin and Flagyl....Medications include Zocor 10mg daily, Asacol 800mg tice daily, Flomax 0.4mg at bedtime. (Zocor and Flomax have been recently held but this has not impacted on the patient's fatigue). The physician concluded, It is possible that this patient may have chronic sequelae from his vaccination with LYMErix. The sequelae include chronic recurring fatigue and immune hypersensitivity with allergic reactions to allergy shots, Ibuprofen, and certain foods. Other possible sequelae include his prostatitis, colitis and neurologic symptoms. Following the reported onset of fatigue, the subject experienced hypertriglyceridemia, influenza, and elbow pain. These events were not reported as adverse events due to vaccine administration, but were found during the course of review of the subject's medical records. Therefore, they are not listed as adverse events. The most recent information received on 4/22/03, indicated that the colitis, allergic reactions, encephalopathy, prostatitis, and fatigue persisted as of 4/15/02. A 15-day follow up report received 10/25/2002 adds: The medical history included allergic rhinitis treated with unspecified allergy shots and hypercholesterolemia treated with simvastatin (Zocot). The pt had no adverse experiences following previous immunizations. In 2000 (exact dates not provided), the pt received his first and second injections of Lymerix. In April 2001 he experienced diarrhea and abdominal pain. The physician made a diagnosis of colitis. In October 2001, he experienced urticaria, bronchospasm, chest pain and fatigue. The physician made diagnoses of "a number of allergies" and "generalized allergic predisposition". In February 2002 he experienced dysuria and urinary frequency. The physician made a diagnosis of chronic prostatis. Treatment of the reported events was not specified. The Lymerix immunization series was discontinued. On 04/29/2002, the physician stated that as of 04/15/2002, the colitis had improved; the chronic prostatitis, allergies and "generalized allergic predisposition" were unresolved. The physician considered the events to be possibly related to Lymerix administration. The physician considered the events to be serious because they jeopardized the pt or required intervention to prevent a serious outcome. On 10/14/2002, the pt's attorney alleged that the pt experienced "left sided colitis, acute prostatis, severe allergic reactions, right sided weakness felt to be consequence of encephalopathy and chronic recurring fatigue". The attorney indicated that the events began on 08/01/2000, and that medical treatment began in August 2000. The attorney indicated that the pt did not require hospitalization, and "time lost from work" was "not applicable". The attorney alleged "permanent injury: Chronic recurring fatigue, immune hypersensitivity, colitis and neurological symptoms which are under evaluation." The attorney further alleged that these events "were caused by the Lyme's (sic) disease vaccine, Lymerix." Encephalopathy is considered medically serious (OMIC). The follow up received on 11/10/03 states on 1/2/03, a second attorney alleged that the vaccinee received two injections of LYMERix in August 2000; exact dates were not provided. The attorney alleged that the subject "decline dthe third and final vaccination due to the severe fatigue and increased sensitivity to cold that (he) was experiencing. Thereafter, (he) experienced severe fatigue, protracted diarrhea, severe allergic reactions, encephalopathy in the right leg (sic), acute prostatitis and protracted anorectal pain. As such, (he) has been left to suffer with what has thus far been incurable and at time sdebilitating pain which severely limited his employment options and opprotunities." The following info was obtained from medical records. The subject presented to the vaccine provider on 12/21/00 with a complaint of "persistent fatigue since receiving two Lyme vaccinations this past summer. He additionally has had intermittent twinges of right mid chest discomfort for the past several months. A recent stress echo was unrevealing. Pt's last complaint is a sense of altered smell since haivng an upper respiratory tract infection in October. This altered sense of smell was persistent for one weeks time and since has been intermittent, occurring three to four times weekly. He describes his altered sense of smell as being a generalized foul smell." Medications at tha time included Simvastatin. Physical examination revealed "focal tenderness over hte right mid anterior chest just at the costochondral junction of the sixth rib." The physician's impressions were "1.Persistent fatigue. 2. Right anterior chest pain-questionable costochondritis. 3.Altered sense of smell." The physician discontinued Simvastatin therapy. Lab analyses performed on 1/2/01 revealed abnormalities. The subject remained under the care of the vaccine provider until at least 4/15/02. During this time, the subject reported "persistent fatigue which now prevents him from exercising and frequently prompts him to take a nap in the afternoon," "mild frontal headache," "fleeting" vertigo, intermittent testicular discomfort and a sense of fullness in his rectum, and "mild" dysuria. The subject underwent enteroscopy for evaluation of iron deficiency, positive gliadin antibody, and negative endomysial antibody on 3/19/01. The physician's impressions were "Unremarkable proximal small bowel. Diffuse mild gastritis. Small histus hernia." The subject underwent colonoscopy for evaluation of iron deficiency and new-onset diarrhea on 4/11/01. The physician's impression was "Probable mild left sided colitis (aphthae were more numerous and more proximal in location than one sometimes can see as a consequence of the bowel prep)." Other findings during this time included "slightly boggy and tender prostate" (12/6/01); "palpable internal hemorrhoids" (9/17/01), and "slightly enlarged tender prostate" (9/17/01). During this time, the physician noted "He has additionally discontinued his Zocor without impact on his fatigue" (1/30/01). "His stamina has improved" (5/30/01), "He no longer requires afternoon nap and he is able to exerciese on a regular basis" (5/30/01), and "his chronic fatigue has resolved." (9/6/01). On 9/17/01, the physician noted that the subject was seen by another physician, "and prostatic masage confirmed the diagnosis" of prostatitis. On 10/19/01, the subject reported that "Two days ago, he had an anaphykactic reaction to his allergy injections which required treatment with Benadryl and epinephrine. He was left with a sense of mild fatigue and chest discomfort when he takes a deep breath." The physician made additional diagnoses of "Chronic fatigue-questionably related to Lyme vaccination" (1/30/01), "Mild headache, fleeting vertigo and intermittent alteration of smell" (1/30/01), "Inflammatory bowel disease with left-sided ulcerative colitis versus granulomatous colitis" (5/30/01), "Iron deficiency probably secondary to inflammatory bowel disease" (5/30/01, "Possible prostatitis" (9/6/01), "Quiescent left side colitis" (9/17/01), "Prostatitis" (9/17/01)," Symptomatic hemorrhoids" (9/17/01), "Anaphylactic reaction to allergy shot" (10/19/01), and "Recent influenza" (10/19/01). The physician prescribed resumption of Simvastatin therapy, and Asacol, an iron supplement, and Levaquin. The physician referred the subject to a neurologist, a colorectal surgeon and an allergist. The subject was evaluated by the neurolgoist on 2/1/01. At that time, the subject reported that "since September of the year 2000 has been overly fatigued, more with more difficulty in concentration, poor balance. He lost his balance a couple of times while going up stairs and sometime in October while at the airport he had a very foul smell which ahs not completely subsided. This happened after he had received two shots for vaccination for Lyme disease." The neurolgoist noted that the subject "had a bout of transverse myelitis at the age of 21, his symptomatology lasted for about 30 days and he had a meylogram." On examination, "He performs well on higher mental tasks. There was no symbolic language deficit. His neurological examination was nonfocal. My clinical impression is encephalopathy, etiology unclear." The neurologist prescribed Provigil. Serologies revealed elevated Epstein-Barr titers "suggestive of an Epstein-Barr virus infection at  some undetermined time in the past" and elevated gliadin IgG and IgA. The subject was evaluated by a colorectal surgeon on 2/1/02. He reported a "four-day history of anorectal pain. The pain started after he developed diarrhea following the cessation of his Asacol last week. He restarted the Asacol when he developed several loose, nonbloody bowel movements per day. The anorectal pain is constant and is exacerbated by sitting. He has had some night sweats but he denies any fever or drainage." On physician examnation, the surgeon noted "mild excoriations and inflammation in the left lateral quadrant 2cm from the anal verge. There is point tenderness at this location but no fluctuance or erythema. Digital rectal exam reveales no fluctuance or masses. There is no evidence of a fissure or fistula on today's examination. Under sterile conditoin, a needle aspiration was performed at the area of tenderness and there is no evidence of an abscess. The etiology of his anorectal pain is unclear but it might be related to an early abscess or possibly fromt he superficial ulcerations of the anoderm. He is planning on traveling for the next several days so I prescribed Levaquin and Flagyl. I also advised warm baths and I prescribed a topical anesthetic cream." The subject was evaluated by an allergist on 4/8/02. At that time, the subject reported that he received his second injection of LYMErix in September 2000 "and within 60 to 90 minutes felt the abrupt onset of general malaise, heat, sweating and extreme fatigue. His chief complaint is persistence of these symtpoms, with waxing and waning degrees, to the present. He has been on immunotherapy for years for allergic rhinitis and was on monthly maintenance doses but had a major anaphylactic reaction for the first time December 2001. One month later he took Celebrex and within 1.5 hrs also had an anaphylactoid reaction also characterized by systemic urticaria and significant bronchospams requiring emergency treatment. He had previously tolerated Celebrex although the last time was three to four motnhs before. His review of systems has been notable for frequent episodes of sweats since September 2000 occurring approximately two to three times per week either during the day or night often associated with a sense of warmth and flushing. His chief complaint has been constant extreme fatigue. He usually works 60 to 80 hrs per week and went to the gym five out of seven days. His workout is now cut and he goes to a gym two out of seven days with 50% of his regular exercise regimen. At the time I saw him a detailed physical exam was completely unrermarkable. IMpression: I am not sure what has caused his varied symptoms all occurring since the second Lyme vaccine September 2000. There is no common immune mechanism to describe his problems since then. Remotely the colitis is autoimmune (antibody or T-cell mediated). The prostatitis and early abscess suggest decreased immune activity, if indeed they are related. His anaphylaxis to the immunotherapy is specifically IgE mediated whereas the reaction to the Celebrex is oversensitivity to increased production of leukotrienes with no specific immune mechanism involved. One remote theoretical possibility is that the second Lyme vaccine stimualted his antigen presenting cells which responded by acutely releasing cytokines including TNF and IL2. //These certainly induce flu-like symptoms including fever and sweats. Remotely they may still be overly active, giving him his baseline symptoms of fatigue and episodic sweats although these have decreased from the September 2000 onset. Cytokines from antigen presenting cells certainly have the capacity to trigger the rest of the immune system and remotely may have contributed to colitis, if it is immune mediated and possibly to his anaphylaxis. Association of the other problems becomes more remote. It is almost impossible to determine if this is the case, because of current limits of available tests." On 4/15/02, the vaccine provider wrote a medial summary for the subject. He wrote, "The subject is a 51 year old gentleman who received the Lyme vaccination in August of 2000. After receiving the second in the series of three vaccinations, the pt developed severe fatigue and increased sensitivity to cold, prompting a decision not to administer the third and last in the series of three Lyme vaccinations. The pt's fatigue persisted throughout the remainder of the year 2000 and through 2001. It began dissipating earlier this year but has recently re-intensified. In addition, the pt devleoped several other problems subsequently to his Lyme vaccination. These problems include: 1.Protracted diarrhea which proved to be secondary to left sided colitis at colonoscopy in March of 2001 for which the pt was placed on asacol in treatment. 2.Severe allergic reactions (with bronchospams, chest pain and diffuse urticarial) secondary to allergy injections and Ibuprofen and recently ketchup and salad dressing. 3.Transient intermittent consulation of foul smell an da sense of weakness in the right leg for which the pt was seen in neurolgoic consultation and which was felt to be the consequence of encephalopathy of unclear etiology. 4.Acute prostatitis in January of 2002 with residual symptoms through this point in time. 5.Recent bout of protracted anorectal pain for which he was seen by a colorectal surgeon and which was felt to be possibly secondary to an early abscess and for which he was placed one a course of Levaquin and Flagyl. Medications include Zocor 10mg daily, Asacol 800mg twice daily, Flomax 0.4mg at bedtime." The physician concluded, "It is possible that this pt may have chronic sequelae from his vaccination with LYMErix. These sequelae include chronic recurring fatigue and immune hypersensitivity with allergic reactions to allergy shots, Ibuprofen and certain foods. Other possible sequelae include his prostatitis, colitis and neurologic symptoms." The pt was seen again by his allergist on 6/13/02. At that time the physician commented that the pt experienced "multiple medical symptoms somewhat associated with immune activation with the abrupt onset coincident with a second Lyme vaccine." The results of further evaluation of the pt's immune system from 4/3/02 were normal or negative. These tests included "quantitative lymphocyte analysis, sub-set, mitogen response to T and B cell stimulants, immunoglobulins, complement factors and a repeat CRP (C-reactive protein). The Lyme antibody test was also negative. The physician commented that "although the abrupt onset of 90 minutes is unusual, if is not inconceivable after a previous vaccine. The persistence of systems suggests an aberrant immune response, possibly with continued low level production of these cytoknes from antigen processing cells such as dendritic cells, monocytes and keratinocytes. "This may have been a rock in the pond that subtly disrupted other aspects of his immune network balance." Following the reported onset of fatigue, the subject experienced hypertriglyceridemia, influenza, and elbow pain. These events were not reported as adverse events due to vaccine administration, but were found during the course of review of the subject's medical records. Therefore, they are not listed as adverse events. The most recent info received on 11/10/03 indicated that "to some degree," the pt's symptoms had continued into June 2002. Information received on 4/22/03 indicated that the colitis, allergic reactions, encephalopathy, prostatitis, and fatigue persisted as of 4/16/02. A 15-day follow up received 12/24/2003 adds: The most recent info received on 12/16/2003 did not provide the outcome of the reported events.