Age: 42.0
Sex: F
Vaccine: LYME
Symptoms: Arthralgia, Colitis, Fatigue
Clinical narrative: This report describes colitis in a female vaccinee of unspecified age who received LYMErix. This report was received as part of litigation proceedings and has not been verified by a physician or other healthcare professional. The medical history included temporomandibular joint syndrome. Concurrent conditions and medications were not provided. The vaccinee reportedly recieved LYMErix; the number of injections was not reported. In a statement of injuries, her attorney alleged that the vaccinee "experiences joint pain and fatigue. She also suffers from colitis." Time to onset following immunization, treatment, and outcome of the alleged events were not reported. The adverse event "joint pain" does not meet serious criteria but is being submitted as an expedited report by special FDA request.  Follow up 07/01/2002: "Following the reported onset of ulcerative colitis, the vaccinee experienced iron deficiency anemia, thrush, hypokalemia, anal fissures, hypoalbuminemia, and a left adrenal mass.  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.  In May 1999, the vaccinee reportedly received LYMErix; the number of injections administered was not reported.  In a statement of injuries, her attorney alleged that the vacicnee "experiences joint pain and fatigue.  She also suffers from colitis."  The following information was obtained from medical records.  On 12/12/2000, the vaccinee was seen by a physician.  She reported that she had presented to the local emergency room on 12/10/2000 with a complaint of loose stool with diarrhea.  Reportedly, the vaccinee's white blood cell count had been elevated.  She stated that the emergency room physician had made a diagnosis of gastroenteritis and prescribed diphenoxylate/atropine and dicyclomine "without much therapy".  Discontinued Lomotil therapy, and prescribed loporamide.  The vaccine returned to the physician on 12/14/2000 with a complaint of 'chronic problem with loose bowels now with blood.  On Bentyl, legs hurting.  Blood is chronic as well.  Temperature/chills-lower abdominal pain."  The physician prescribed ciprofloxacin 500mg twice daily.  On 12/18/2000, he prescribed Bentyl 20 mg four times daily.  The vaccinee returned to the physician on 12/26/2000.  She stated that her symptoms were improving,  but weakness and dizziness persisted and she had sweats at night.  On 12/29/2000 she had crampy abdominal pain with one to two formed stool with some blood.  She reported fevers of 102 to 104 F, in the physician's office, her temperature was 101.6 F.  The physician's assessment was "persistent fever-diarrhea-weight loss-looks toxic, weak.  Plan: will hospitalize."  On 12/29/2000, the patient was admitted to the hospital.  The hospital discharge summary indicated that she had experienced weight loss of approximately 10 pounds.  It was also noted that she had received intravenious fluids in the emergency room on 12/10/2000.  On examination, "she was febrile.  The abdomen was slightly tender in the left lower quadrant."  The attending physician wrote, "It was clear that she probably had a granulomatous colitis and she was treated with some intravenious antibiotics and then steriods."  She was discharged from the hospital on 01/01/2001; discharge medications were prednisone 20 mg daily and metromidazole 500mg three times daily.  Discharge diagnoses were "1) regionalenteritis of the large intestine. 2) Fever."  The physician completed a disability certification, stating that the vaccinee was unable to work from 12/29/2000 through 001/08/2001, due to "Crohn's Disease-granulomatous colitis."  Colonoscopy was performed on 01/03/2001 and showed colitis with a normal ileum.  On 01/29/2001, the physician sent the vaccinee to the local emergency room "for evaluation of colitis".  Medications at that time included prednisone, Tentyl, and Immodium.  Laboratory analyses revealed decreased serum sodium, serium chloride, serum calcium, red blood cell count, hemoglobin, and hematocrit.  Red cell distribution width was increased.  White blood cell count was within the reference range; however, neutrophil count was reduced while banded neurtophil count and monocyte count here elevated.  Computed tomography of the abdomen with intravenous contrast demonstrated "small hiatal hernial, low attenuation lesion in the left adrenal gland.  Long segment inflammatory changes involving the distal colon."  She received a single intravenous injection of ketorolac 30mg and was sent home from the emergency room  On 02/01/2001, platelets count and erythrocyte sedimentation rate were elevated.  On 02/05/2001, the vaccinee was hospitalized for further evaluation and treatment.  Medications at the time of admission included prednisone 10 mg four times daily, mesalizine tablets, and mesalizaine enemas.  She was  having six BM day, two formed.  Negative weight gain.  Positive fever/chills.  negative nausea/vomiting."  On examination, her temperature was 39.9 degrees C.  There was "mild" tenderness in the left lower quadrant of the abdomen.Internal and external hemorrhoids were observed.  she was treated with intravenous hydrocortisone 100mg every 8 hours.  Asacol 800mg 3 times daily; intravenous famotidine 20 mg daily, and intravenous ampicillin/sulbactam 3g every 6 hours.  The vaccinee was seen by an infectious disease specialist on 02/06/2001 who noted that the vaccinee "was diagnosed early last month with inflammatory bowel disease.  Her symptoms at that point were present for approximately three to four months, were associated with low grade temperatures, weight loss and chronic diarrhea.  She was eventually admitted with protracted fever and night sweats and was found to have Excherichia coli sepsis at that time.  She was treated with antibiotics as well as steroids and Roasa enemas after the diagnosis of ulcerative colitis was made and she did well.  Her symptoms were remitting over the ensuing several weeks, although over the past two to three weeks, she has had little progression of her symptomatology despite continued steroid use."  The specialist wrote "The impression is that of recurrent flares of ulcreative colitis in an otherise healthy, 42 year old female....She has an anemia, she has hyperkalemia and hypoatremia and the concern for adrenalitis must also be entertained".  He recommended discontinuing Unasyn therapy.  He recommended intravenous levofloxacin and metronidasole.  She received intravenous Levaquin 500mg daily from 02/06/2001 to 02/13/2001, at which time therapy was changed to 500mg orally, once daily.  She received intravenous Flagyl 500mg three times daily from 02/06/2001 to 02/13/2001, at which time therapy was changed to 500mg orally, three times daily.  Laboratory analyses during hospitalization revealed decreased serum calcium, potassium, total serum protein, serum albumin, aspertatc aminotransferase, red blood cells, hemoglobin, hematocrit, and lymphocytes.  alamine aminotransferase, erythrocyte sedimentation rate, prothrombin time, neutrophils, and red cell distribution width were increased.  Blood, uring, and stool cultures were negative.  Serologies for human immunodeficiency virus (HIV) types 1 and 2 were negative.  Results of Ct of the pelvis without contrast, CT of the abdomen with contrast, and Gerisac white blood cell study were consistent with ulcerative colitis.  Sigmoidescopy "slightly favors Crohn's disease versus ulcerative colitis."  left colon biopsy revealed "Acute and chronic colitis.  Moderately severe with ulceratoid, granulation tissue, cryptitis, crypt abscesses and inflammatory lymphoid infiltrate.  No granulomas indentified.  No dysplasia seen.  The findings are consistent with inflammatory bowel disease."  Biopsy of tissue obtained during the colong share polypectomy revealed "Tubulovillous adenoma with focal moderate dysplasia."  During hospitaliztion, the vacinee was treated with prednisone, Asscol, Rowasa enemas, oral pepcid, sucralfate, suspension, docusate sodium, and psyllium.   The patient defervesced and the pandemis slowly resolved.  The patient was also evaluated by another physician due to refractory anal pain with hemorrhoidal disease and conservative treatment was recommended (witch hazel) pads, hydrocortisone cream and suppositories, lidocaine/prilocaine cream, and oxycodone/paracetamol/"  Hypokalmeia was treated with oral potassium chloride.  Anemia was treated with ferrious sulfate.  Thrush was treated with oral fluconazole.  "Eventually, her oral intake was satisfactory and her bowel movements were controlled.  Her anal pain slowly resolved, however, she did require narcotics at times during this hospitalization."  The vaccinee was discharged from the hospital on 02/14/2002 with a primary diagnosis of inflammatory bowel disease.  Additinal diagnoses included iron deficiency anemia, bloody diarrhea, condidasis, hypokalemia, anorectal ulcerations, hemorrhoids, anal fissure, and hypoalbunimonia. Medications at the time of discharge included prednisone 10mg four times daily, Asacol 400mg three times daily, Rowasa enema twice daily, Percocet every four to six hours as needed for pain relief, and a multivitamin.  By 03/12/2001, she was returned to work on a part-time basis.  On 01/15/2002, erythrocyte sedimentation rate was within the reference range.  Ferritin concentration was reduced.  Serology for hepatitis C was negative.  The vaccinee returned to her psychotherapist on 02/12/2002.  She stated that "her rheumatologist thinks her colitis was connected with vaccine (LYMErix) and caused her arthritis - discussed possible relation to stress".  The chronology recorded by the psychotherapist indicated that the vaccinee received LYMErix in may 1999, and that the symptoms of ulcerative colitits began in Sept 2000.  The most recent information, received 03/13/2002, indicated that the ulcerative colitis and joint pain persisted as of 02/12/2002.  The outcome of the fatigue was not specified.  Follow up on 09/09/2002: "From 10/16/2001 to at least 05/14/2002, the patient was treated by another physician.  During this time period, the physician noted that the vaccinee was being treated with intravenous infliximab and paroxetine hydrochloride.  She noted that joint pain had resolved.  The physician's assessments were: 1) Lyme vaccine 2) Inflammatory bowel disease".  A variety of serologies for Lyme disease were performed on 10/18/2001.  The laboratory's interpretation was "No evidence of seroactivity beyond that expected from the Lyme vaccine."  Additional laboratory analyses performed were within the reference ranges.  The most recent information received 08/23/2002, indicated that the joint pain resolved and the ulcerative colitis persisted as of 05/14/2002."  Follow up on 07/31/2003: "The most recent information, received on 07/24/2003, did not provide the outcomes of the reported events.  Information received on 04/28/2002 indicated that the vaccinee had "no further episodes of colitis" as of 03/16/2002.  The joint pain resolved as of 05/14/2002.  Fatigue persisted as of 03/16/2002." A 15-day follow up report received 09/09/2003 adds: On 03/21/2002, the pt consulted a surgeon regarding elective facial cosmetic surgery. At that time, she reported that she was taking no medications. On an unspecified date between 02/12/2002 and 05/14/2002, the pt told her psychologist that she was "very depressed" and another healthcare provider had prescribed paroxetine (Paxil). The pt was seen by her psychologist on 05/14/2002. At that time, she was "feeling much better-smiling now." The psychologist noted "lack of concentration and focus as well as depression. May be symptoms of Lyme vaccine." The pt returned to the psychologist on 06/03/2002. The psychologist noted, "feeling well - feels Paxil is working." The pt was discharged from the psychologist's care on 10/22/2002. The pt presented to a new physician on 02/06/2003 for treatment of upper respiratory symptoms (non-event). At that time, she reported that she was changing careers and "getting her graduate degree". The pt reported that she was "off all medications other than OTC multivites and supplements." The most recent info, received on 08/20/2003, did not provide the outcomes of the reported events. Info received on 04/28/2003 indicated that the pt had "no further episodes of colitis" as of 03/16/2002. The joint pain resolved as of 05/14/2002. Fatigue persisted as of 03/16/2002.