Report 2001003784-1 described possible progressive small fiber neuropathy in a 40 year old male who received Hep B vaccine recombinant (Engerix-B) for prophylaxis of Hep B. This report was received from the vaccinee and has been verified by a physician. On 05/05/99, and 06/11/99, the vaccinee received his first and second dose of Engerix-B, respectively. Six days after receiving the 2nd dose of Engerix-B, on 06/17/99, the vaccinee experienced pain, burning, and numbness on all limbs, trunk, and face. The neurologist considered these events to be severe in intensity. The neurologist made a diagnosis of possible progressive small fiber Neuropathy in 01/00, and treated the patient with gabapentin (Neurontin), and hydrocodone bitartrate/ paracetamol (Lortab). He was also taking paracetamol / oxycodone hydrochloride (Percocet). On 03/06/01, the neurologist reported that these adverse events were disabling / incapacitating and possibly related to Engerix-B. However, the neurologist also stated "unclear if related". As a result of the information received on 03/06/01, this report has been reclassified as serious, unexpected. As of 03/01, the outcome of the adverse events was resolved. The follow up received on 5/31/01 states pt medical history also included numerous motorcycle accidents and broken bones from 1975-1980. Other concomitant medications included Claritin, Acyclovir, multivitamin, Lariam, and Ambien. The pt reported occasional marihuana use. His family hisotyr was remarkable for Parkinson's disease. The vaccinee experienced numbness in his left great toe. The numbness proceeded to involve both legs from the knees down. He then developed tremors on twitches in his arms and legs, which he considered to be muscle spasms. Following that he experienced burning of both arms and legs, chest and back. He developed an intermittent rash over his joints, "which was burning and painful. Additionally, he experienced "severe" fatigue and weight loss. He was treated with a one-week course of prednisone without improvement. 8/14/00: Neurology referral letter: electrolyte analysis, creatinine, creatinine phosphokinase, all were normal or negative. While taking B6 supplements, his b6 level was elevated at 90. After discontinuation of supplements, the B6 level was normal at 39.5. Cerebrospinal fluid analysis performed in December 1999 revealed one white blood cell, 402 red blood cells, glucose 66, protein 52, negative VDRL, negative CRAG, and a normal IgG index. CSF obtained on 4/21/00 showed 3 WBC, 0 RBC, protein 44, glucose 64, non-reaction VDRL, IgG index 0.8, and negative oligoclonal bands. Sjogren's evaluation by an ophthalmologist was negative. Qualitative sensory testing was negative. Review of system was remarkable for five out of six since symptoms for dry eyes and mouth. The pt was "mildly unsteady with tendem gait. On sensory examination, proprioception, touch and vibration have normal thresholds in the hands and feet. Pin and temperture are decreased to the knees bilaterally, while touch, vibration, and proprioception ahve normal thresholds in the hands and feet. Rhomberg sign is negative. The neurologist's impression was "clinically he appears to have a progressive small fiber neuropathy, however documentation of the neuropathy with testing and its etiology remain clusive." 8/22/00-skin biopsy report: epidermal nerve fiber density is within a normal range at all three sites (proximal thigh, distal thigh, distalleg); therefore, there is no definite evidence of a neuropathic process affecting small caliber nerve fibers. The nerve fiber swellings noted at the distal leg site are, however, suggestive of early nerve fiber degeneration and depending on the pt's clinical progression. A repeat biopsy in 3 to 6 months' time may be useful. 1/9/01-pain center evaluation. At this time, the pt reported some yellowing of his skin, "which may or may not be related to excessive carotene intake," and also abdominal pains with nausea, vomiting, and diarrhea. He reported that he occasionaly had dark, foul-smelling urine. The pt described his pain as shotting and stabbing, with a burning component. He described it as being constant, with frequent flares. He "described his sleep habits as poor secondary to his mind being somewhat over-stimulated at night." He was unsable to participate in his usual recreational activities, including mountain biking and basketball. He reported that MRI of the head, cervical, thoracic, and lumbar areas, perfomred one year prior, were negative. The pt had trials of Elvail and Tegretol, which exacerbated his symptoms. Acupuncture, vitamin B6, Zoloft, amantadine and ibuprofen were all ineffective. He noted that being in a hot tub gave him some temporary relief. The pt also found physical therapy to be somewhat effective. At the time of the evaluation, his medication regimen included Lidodera patch, Neurontin 500mg five times daily, Wellburtin SR 100mg twice daily, Ambien 20mg at hour of sleep, Lortab 7.5/00mg one tablet four times daily, and acyclovir 200mg daily. he also recommended tyring Topamax, Gabitril, or mexilatine for pain relief. The most recent info was received from the neurologist on 5/31/01. The latest record forwarded was dated 2/12/01 and indicated that the pain was ongoing. The record dated 2/1/01 indicated that the pain, tremulousness, fatigue, and episodes of confusion were ongoing and disabling. The outcomes of the rash, weight loss, yellowing of the skin, abdominal pains, nausea, vomiting, diarrhea, dark urine, and foul-smelling urine werre not provided.