This report described the occurrence of aplastic anemia in a male pt who received Lyme disease vaccine recombinant OspA (LYMErix) for prophylaxis. This report was received as part of litigation proceedings, and has not been verified by a physician or other health care professional. The pt's medical history, concurrent conditions, and concurrent medications were not reported. The pt received injections of LYMErix on 5/16/99, 6/20/99 and 12/2/99 "according to (the pt's) counsel." This represents a schedule of 0, 1 and 6 months rather than the recommended schedule of 0, 1, and 12 months. On 10/31/03, the pt's attorney alleged that the pt's "aplastic anemia was caused by vaccination with LYMErix." The pt will "undergo chemotherapy this month and is preparing for a stem cell transplant after the second week of November 2003." The outcome of the event is unresolved. The event of aplastic anemia is considered to be medically serious (OMIC).  Follow up on 12/24/2003: "The following information was provided via the pt's medical records.  Medical records dated 10/22/02 indicated that the pt initially developed mild pacytopenia in 1999, which the pt related to receiving his third Lymerix vaccine.  In Feb 2001, bone marrow biopsy showed normal cellular marrow with erythroid hyperplasia, megaloblastic changes, and occasional dyserythropoietic forms.  On 02/28/02, bone marrow biopsy showed abnormalities with dysplastic changes and macrocytic changes suggestive of a myelodysplastic pattern, although noted to be non-diagnostic.  The pt subsequently experienced recurrent infections, particularly in the lung, including bronchitis and pneumonia.  On 07/17/02, the patient presented with complaints of decreasing exercise tolerance with shortness of breath, dyspnea on exertion, and multiple epidoses of productive cough (sometimes greenish, sometimes brown, sometimes with blood).  He was noted to have previously received antibiotic therapy on three occasions, which did not work.  He had been placed on inhalers which were noted to be "helping somewhat".  At that time, it was noted that the pt had a "four year history of blood disorder, evidently low platelets, low blood count and white blood counts."  He was diagnosed with pancytopenia as well as possible "asthma", COPD-type problem that has been acting up."  However, spirometry findings were within normal limits.  At the time, the pt refused a transfusion.  Diagnostic tests revealed decreased white blood cell, red blood cell, hemoglobin, hematocrit, platelet, and neutrophil values, and elevated RDW and lymphocyte values.  Lyme testing was positive on 07/17/02.  On 08/13/02 the pt was again evaluated, at which time it was noted that his reduced blood count had been present for approximately three years.  His blood count upon examination was "not as sseverely reduced", although he complained of increasing weakness, shortness of breath, "a little bit" of weight loss, and difficulty functioning.  Review of a peripheral smear showed few platelets, abnormal red cell morphology, and lymphocytes with the appearance of "hairy cells".  The examining physician stated that the clinical picture "fit best" with some kind of myelodysplasia or preleukemia.  On 08/21/02 at which time the pt experienced a syncopal episode.  He was transferred to the ER and diagnostic tests revealed decreased white blood cell and hemoglobin.  IV normal saline was initiated, and the pt agreed to be admitted for further work up of pancytopenia and questionable pre-leukemic state.  He received platelet and packed cell transfusions.  Bone marrow biopsy revealed severe pancytopenia, and very hypocellular marrow with decreased in all lines but no evidence of malignancy.  He was diagnosed with aplastic anemia.  On 09/09/02, the pt reported that he was feeling better following the transfusions.  On 10/22/02, the pt was examined for recurrence of anemic symptoms including shortness of breath, pale appearance, and fatigue.  No underlying malignancy was detected.  It was noted that his bone marrow was progressively abnormal, consistent with myelodysplastic syndrome.  Pancytopenia was limiting his ability to work.  He received four units of packed red blood cells, and was referred for continued tx with antithymocyte globulin.  He was admitted to the hospital on 10/23/02 with critical platelet and white blood cell values.  On 11/20/02, plan included that he receive five units of packed red blood cells "very soon" due to aplastic anemia with severe anemia.  He was also noted to be thrombocytopenic at that time.  Medical history provided by the pt included repeated episodes of upper respiratory infection treated with antibiotics, pneumonia, and bronchitis in the preceding three years (since approximately Jan 2000).  The pt was evaluated on 11/21/02 with aplastic hematopoiesis.  The pt was lost to followup until 01/27/03, when he presented with fever, weakness and decreased blood counts.  He received transfusion support for red marrow transplant.  On 03/18/2003, the pt presented to the ER with a several weak history of increasing shortness of breath, fatigue, and lightheadedness upon standing.  He was hospitalized via the ER with decreased hemoglobin, hematocrit, platelet, and white blood cell values.  He was admitted sibling for transplat, but it was recommended that he receive antithymocyte globulin and cyclosporin prior to undergoing bone marrow transplant.  Blood counts improved, and the pt was discharged on 03/19/2003 after declining further care.  On 05/16/03 the pt was admitted to the hospital in extromis.  Symptoms included pulmonary hemorrhage.  He received IV fluids for hypotension and respiratory status was stabilized on hemoptysis.  Multiple sets of blood cultures were negative, and tx included imipenem.  An abdominal ultrasound revealed likely cholecystitis which slowly improved following IV antibiotic therapy.  A cholecystectomy was determined to be risky due to pancytopenia.  Computed tomography scan showed some fluid in the left pelvis and very definite left lower lob pneumonia.  Extensive left lower lobe infiltrate with area of dense consolidation with hemoptysis was noted, in addition to severe pancytopenia due to aplastic anemia and diarrhea.  Potential causes of abdominal pain included biliary tract disease, possible cholengitis, or possible cholecytitis.  Ultrasound showed a gallbladder filled with sludge and some wall thickening, although follow up ultrasound showed less thickening.  Treatment while hospitalized included Benadryl, Primaxind, Solumedrol, Neupogen, Protonix, antithymocyte globulin, platelet and red blood cell transfusion, and cyclosporin. During the course of hospitalization blood counts fluctuated although remained low, and he continued to experienced postprandial lower quadrant abdominal pain accompained by flatus.  It was noted that the symptoms "could be a diverticulitis...(i)t may be a focal colitis or opportunistic infection involving the colon."  During the course of hospitalization liver enzymes were normal although hyperbilirubinemia was noted.  Diarrhea was considered most likely due to antibiotics.  He was discharged on 06/16/03.  On 06/18/03 he was rehospitalized after presenting with acute onset of upper abdominal pain with nausea and vomiting.  Bilirubin was elevated.  He received pain control (morphine) and IV antibiotics.  A weight loss of 20 to 25 lbs in the preceding month was noted.  Impression included biliary colic, possible acute cholecystitis, aplastic anemia, and cholelithiasis.  On 06/20/03 he underwent attempted laparoscopic cholecystectomy with conversion to open cholecystectomy and negative intraoperative cholangiogram.  White blood cell, hemoglobin, hematocrit and platelet values remained low.  Treatment included Phenergan, Toradol, and Reglan.  On 12/18/2003, the pt's attorney reported that the pt had passed away on 12/16/2003.  There was no death certificate or other information to provide the possible cause of death.  It is unknown whether an autopsy was performed.  Following the reported onset of pancytopenia/aplastic anemia, the pt experienced a syncopal episode on 08/20/02 following a bone marrow biopsy, and hypertension likely associated with cyclosporin therapy.  These were not reported as adverse events due to vaccine administration, but were found during the course of review of the pt's medical records.  Therefore, they are not listed as adverse events.   Follow up on 01/08/03: " The pt's medical history included smoking, drug use, and alcohol use.  His blood pressure was noted to be high at times.  The pt's profession brought him into proximity of wilderness fires.  Medical records confirmed that the pt received injections of LYMErix on 05/16/99, 06/20/99, 06/20/99, and 12/02/99.  This represents a schedule of 0,1, and 6 months rather than the recommended schedule of 0.1 and 12 months.  On 10/31/03, the pt's attorney alleged that the pt's "aplastic anemia was caused by vaccination with LYMErix."  The pt will "undergo chemotherapy this month and is preparing for a stem cell transplant after the second week of Nov 2003."  The outcome of the event is unresolved.  The event of aplastic anemia is considered to be medically serious.  The following information was provided via the pt's medical records.  On 02/25/00, a complete blood count revealed decreased red blood cell, white blood cell, hematocrit, and platelet counts, and red blood cell morphology was abnormal.  This was noted to be consistent with viral infection, and diagnoses included pancytopenia with thrombocytopenia.  In a letter dated 04/07/00, the pt's physician stated that the pt's symptoms began in early 01/00, the month after his most recent LYMErix vaccination, and that "it was most likely that his leukopenia is related to his immunization".  Diagnostic tests dated 01/01/01 revealed thrombocytopenia, leukopenia, and macrocytic red blood cell indices.  Approximately two weeks later, a complete blood count revealed low white blood cell, red blood cell, hemoglobin, hematicrit, and platelet values that were considered to be "consistent with viral syndrome".  Medical records dated 10/22/02 indicated that the pt initially developed mild pancytopenia in 1999, which the pt related to received his third LYMErix vaccine.  On 02/27/01, bone marrow biopsy showed normal cellular marrow with erythroid hyperplasia, megaloblastic changes, occasional dyserythropoietic forms, myeloid hypoplasia with left shift, megakaryocytic hyperplasia with occasional dysplastic forms, increased iron stores and no anemia, with macrocytic red cells.  Significant blood and marrow findings included neutropenia, thrombocytopenia, macrocytosis, erythroid hyperplasia, and relative myeloid hypoplasia.  Blood and marrow findings were considered to be possibly representative of early myelodysplastic syndrome, without evidence of acut leukemia.  On 02/28/02, bone marrow biopsy showed abnormalities with dysplastic changes and macrocytic changes suggestive of a myelodysplastic pattern, although noted to be non-diagnostic.  The pt subsequently experienced recurrent infections, particularly in the lung, including bronchitis and pneumonia.  ON 07/17/02, the pt presented with complaints of decreasing exercise tolerance with shortness of breath, dyspnea on exertion, and multiple episodes of productive cough (sometimes greenish, sometimes brown, sometimes with blood).  He was noted to have previously received antibiotic therapy on three occasions, which did not work.  He had been placed on inhalers which were noted to be "helping somewhat".  At that time, it was noted that the pt had a "four year history of blood disorder, evidently low platelets, low blood count and white blood counts."  He was diagnosed with pancytopenia as well as possible "asthma, COPD-type problem that has been acting up".  However, spirometry findings were within normal limits.  At that time, the pt refused a transfusion.  Diagnostic tests revealed decreased white blood cell, red blood cell, hemoglobin, hematocrit, platelet, and neutrophil values, and elevated RDW and lymphocyte values.  Lyme testing was positive on 07/17/02.  On 08/13/02 the pt was again evaluated, at which time it was noted that his reduced blood count had been present for approximately three years.  His blood count upon examination was "not as severely reduced", although he complained of increasing weakness, shortness of breath, "a little bit" of weight loss, and difficulty functioning.  Review of a peripheral smear showed few platelets, abnormal red cell morphology, and lymphocytes with the appearance of "hairy cells".  The examining physician stated that the clinical picture "fit best" with some kind of myelodysplasia or preleukemia.  On 08/21/02 the pt presented with pacytopenia and was pale in appearance.  A bone marrow biopsy was performed on 08/21/02, at which time the pt experienced a syncopal episode.  He was transferred to the ER and diagnostic tests revealed decreased white blood cell and hemoglobin.  IV normal saline was initiated, and the pt agreed to be admitted for further work-up of pancytopenia and questionable pre-leukemic state.  He received platelet and packed cell transfusions.  Bone marrow biopsy revealed severe pancytopenia, and very hypocellular marrow with decrease in all lines but no evidence of malignancy.  He was diagnosed with aplastic anemia.  On 09/09/02, the pt reported that he was feeling better following the transfusions.  On 10/22/02, the pt was examined for recurrence of anemic symptoms including shortness of breath, pale appearance, and fatigue.  No underlying malignancy was detected.  It was noted that his bone marrow was progressively abnormal, consistent with myelodysplastic syndrome.  Pancytopenia was limiting his ability to work.  He received four units of packed red blood cells, and was referred for continued treatment with antithymocyte globulin.  He was admitted to the hospital on 10/23/02 with critical platelett and white blood cell values.  On 11/20/02, plan included that he receive five units of packed red blood cells "very soon" due to aplastic anemia with severe anemia.  He was also noted to be thrombocytopenic at that time.  Medical history provided by the pt included repeated episodes of upper respiratory infection treated with antibiotics, pneumonia, and bronchitis in the preceding three years (since approximately 01/2000).  The pt was evaluated on 11/21/02 with aplastic hematopoiesis.  The pt was lost to follow up until 01/17/03, when he presented with fever, weakness and decreased blood counts.  He received transfusion support for red blood cells and platelets.  At that time, immunosuppresive therapy was recommended rather than an allogenic bone marrow transplant.  On 03/18/03, the pt presented to the ER with a several week history of increasing shortness of breath, fatigue, and lightheadedness upon standing.  He was hospitalized via the ER with decreased hemoglobin, hematocrit, platelet and white blood cell values.  He was admitted with pancytopenia and received four units of packed red cells and one unit of platelets.  He had a 6/6 matched sibling for transplant, but it was recommended that he received antithymocyte globulin and cyclosporin prior to undergoing bone marrow transplant.  Blood counts improved, and the pt was discharged on 03/19/03 after declining further care.  On 05/16/03, the pt was admitted to the hospital in extremis.  Symptoms included fever, hemoptysis, and extreme abdominal pain.  He was urgently admitted for neutroponic fever and probable pulmonary hemorrhage.  He received IV fluids for hypotension and respiratory status was stabilized on 100% nonrebreather.  Blood counts were decreased and he received a platelet transfusion with partial resolution of hemoptysis.  Multiple sets of blood cultures were negative, and treatment included imipenem.  An abdominal ultrasound revealed likely cholecystitis which slowly improved following IV antibiotic therapy.  A cholecystectomy was determined to be risky due to pancytopenia.  Computed tomography scan showed some fluid in the left pelvis and very definite left lower lobe pneumonia.  Extensive left lower lobe infiltrate with area of dense consolidation with hemoptysis was noted, in addition to severe pancytopenia due to aplastic anemia and diarrhea.  Potential causes of abdominal pain included biliary tract disease, possible cholangitis, possible cholecystitis.  Ultrasound showed a gallbladder filled with sludge and some wall thickening, although follow-up ultrasound showed less thickening.  Treatment while hospitalized included Benadryl, Primaxin, solumedrol, Neupogen, Protonix, antithymocyte globulin, platelet and red blood cell transfusion, and cyclosporin.  During the course of hospitalization blood counts fluctuated although remained low, and he continued to experience postprandial lower quadrant abdominal pain accompanied by flatus.  It was noted that the symptoms "could be diverticulitis...it may be a focal colitis or opportunistic infection involving the colon."  During the course of hospitalization liver enzymes were normal although hyperbilirubinemia was noted.  Diarrhea was considered most likely due to antibiotics.  He was discharged on 06/16/03.  On 06/18/03 he was re-hospitalized after presenting with acute onset of upper abdominal pain with nausea and vomiting.  Bilirubin was elevated.  He received pain control (morphine) and IV antibiotics.  A weight loss of 20 to 25 lbs in the preceding month was noted.  Impression included biliary colic, possible acute cholescytitis, aplastic anemia, and cholelithiasis.  On 06/20/03 he underwent attempted laparoscopic cholestectomy with conversion to open cholecystectomy and negative intraoperative cholangiogram.  WBC, hemoglobin, hematocrit, and platelet values remained low.  Tx included Phenergan, Toradol and Reglan.  On 12/18/03, the pt's attorney reported that the pt had passed away on 12/16/03.  There was no death certificate or other information to provide the possible cause of death.  It is unknown whether an autopsy was performed.  Following the reported onset of pancytopenia/aplastic anemia, the pt experienced a syncopal episode on 08/20/02 following a bone marrow biopsy, flu-symptoms including muscle aches, pain and fever and hypertension likely associated with cyclosporin therapy.  On 07/27/00, the pt experienced multi-trauma injury after being hit by a falling tree limb with associated back, shoulder, hip, and rib pain.  CT scan was negative.  These were not reported as adverse events due to vaccine administration, but were found during the course of review of the pt's medical records.  Therefore, they are not listed as adverse events." Legal Case. No further information available