Submitted to Docket No. 1980N-0208; 69 FR 78281, December 29, 2004 - Bacterial Vaccines & Toxoids Efficacy Review Proposal. This is a 36 year old civilian employee who is being evaluated for encephalitis. This patient appears to have had infectious mononucleosis in 1974 while on active duty in the service. He claims that he has never been right since that time. The illness occurred in 1974 and it was characterized as showing fever to 105F, symptoms suggesting encephalitis, hepatitis with GOT levels in the 250 range. A positive mono spot test, a CBC with 72% lymphs and a weight loss of approximately 20 lbs. Symptoms at that time included vertigo, headaches, memory loss, and personality change. The patient returned overseas and was hospitalized for evaluation. A EEG (1/7/75), was interpreted as abnormal with fast theta background activity. No lumbar puncture was performed. The patient left service 12/76 with 10% disability due to a stomach disorder. The patient has subsequently had multiple problems which he feels may be related to this original illness. The specific problems are the following: Gastrointestinal problems with intermittent diarrhea ascribed to IBD or irritable bowel syndrome; Rheumatology complaints with pain in the large joints, primarily knees, shoulders, and hips. He was seen for this and received medicines with no apparent benefit. Vision problems since 1974 evaluated with no clear diagnosis by an ophthalmologist. Neurologic complaints previously evaluated by a doctor who originally noted Xanax-associated Parkinson's disease in 4/88; a MRI showed mild atrophy and a CT scan was negative. The patient is currently working as a civil servant loading airplanes. His major concern is the multitude of medical problems which he feels may be related to an injection he received during active duty. This has been pursued through a variety of resources, there is apparently no concrete data. Follow up information was received on 12/18/90. This patient was seen on 12/11/90 concerning symptoms of excessive fatigue, joint stiffness, joint pains, insomnia, mental confusion, swollen glands, weakness, dizziness, sensitivity to light, heat and cold sensitivity, memory loss and chronic diarrhea. Most of these symptoms appeared in June 1974, after an episode of possible mononucleosis encephalitis, and the rest within a year or two later. On further discussion, the patient reports that he feels tired, run down, and fatigued all the time. There are times when he can't get out of bed or get up, drinks some coffee, then has to go back to sleep again. He also reports that after several hours of work, all of his symptoms get worse. Since his viral episode in 1974, he has been seen by many specialists and has had extensive testing done in an attempt to find a treatable cause for his condition, but nothing has been found to date to account for all of his symptoms. It is my opinion that he is suffering from Chronic Fatigue Immune Dysfunction Syndrome. His symptoms are very typical of what is seen in CFIDS< and while none of them could not be attributed to other causes, nothing has shown up in his diagnostic testing to date. There is presently no definitive test for CFIDS, and while some tests have been found to be positive in some patients with this condition, they are not consistent enough to be diagnostic for everyone. At this time, the diagnosis is made on the basis of the patient's symptom complex, after ruling out all other known causes for those symptoms, and I feel he is in this category.  Follow up information was received on 11/19/91. This patient was seen by a doctor on 1/9/90 for evaluation of multiple complaints that are noted in my record for that time. My summary states that is was not possible to implicate his previous illness of 1974 in his complaints when seen in 1990. Specifically, it seemed unlikely that a vaccine, injection or toxin exposure could account for these problems. These problems included probable irritable bowel syndrome, joint pains, vision problems, and somewhat vague neurological complaints. I suggested at that time that the best fit was chronic fatigue syndrome. Since that time, the patient has continued to have similar complaints. A purged stool specimen showed E. histolytica and he is currently receiving metronidazole 250mg/tid for 30 days. His intermittent diarrhea, which I previously ascribed to irritable bowel syndrome, has not really changed with this therapy to date. He claims that his joint pains are worse and an x-ray done 10/11/91 showed spondylolethesis. Further laboratory studies at that time showed a IgM of 689 (normal 60-90), a ferritin of 675 (normal 23-233) and triglycerides of 417 (normal 50-200). The patient has been evaluated by a hematologist for the increased ferritin levels but this was not thought an important finding. He has seen by a rheumatologist who concluded that he had fibromyalgia. His personal physician has suggested the diagnosis of chronic fatigue syndrome. He also reports that he has recently had two MRI scans of the head that were negative. The patient continues to work, but claims that his physical problems are making it difficult for him to be productive and he is being considered for disability.