Age: 60.0
Sex: M
Vaccine: LYME
Symptoms: Hypoaesthesia, Laboratory test abnormal, Pain, Paralysis, Red blood cell count decreased
Clinical narrative: Reportedly in 1995, this 60-year-old male experienced fever, intense pain and "lay paralyzed on his bedroom floor" six weeks post second vax. According to the report, the vaccinee developed arthritis, numbness and "widespread tingling" at an unspecified time. F/U the pt had no allergies, HLA typing revealed HLA-DR1, HCL - DR11, HLA-DOS, and HLA-DO. Family history is significant for hypothyroidism in the pt father. Follow-up information: Review of medical records revealed on 2/00 MD visit; the pt reportedly participated in a Lyme vaccine study and he did not know whether he had received the placebo or vaccine. He reported that he had fever and severe myalgias after getting the Lyme vaccine. He believed he had contracted arthritis. The pt had a nml exam in all muscles in both upper and lower extremities. On 4/7/00 MD visit; the consulting physician noted that he had received the pt's medical records, which indicated that the pt had participated in a Lyme vaccine trial and had received 2 of the 3 study injections. The records did not indicate whether the pt had received placebo or vaccine. The pt was seen on 8/3/95 and a dx of fibromyalgia was made. At that time, his MD thought that prednisone therapy "might be underlying joint pathology". On 9/19/00 MD visit; the pt was on no meds and he still is convinced that he had arthritis develop from the Lyme vaccine. Exam was nml. On 11/2/00; the pt presented to the MD with "assorted joint pains", including shoulder aches, hand aches and knee aches. The pt reportedly no longer attributed the joint aches to Lyme vaccine, but now he was concerned about parvovirus B19. He said he had been tested for this and was told it was positive. The MD stated, "It was likely that it was positive at some point in the remote past." On exam, the joints of the hands, wrists, elbows, shoulders, feet, ankles, knees and hips were all nml. Assessment/Plan: "Even if the pt did have the parvovirus B19 antibody, I do not think that accounts for his symptoms." The MD prescribed a 30 day course of Vioxx. As of 3/9/01, the outcome of the events was unknown. On follow-up, it was confirmed that the vaccinee received placebo. On 3/8/95 and 4/10/95, the pt received his 1st and 2nd placebo injections. The 1st injection was reported to the IND and, therefore, is not listed as an adverse event in this report. On 4/10/95, post vax, a cactus needle entered the vaccinee's eye and was treated with hydrocortisone ophthalmic drops from 4/15/95 until 4/21/95 and erythromycin on 4/15/95 and recovered on 4/25/95. On 7/10/95, the pt reported his pain began with bilateral hip pain on approx. 5/25/95, 45 days post vax of 2nd placebo. Prior to the pain onset, he had assisted with his mother's care, which required lifting. The hip pain lasted until approx. 6/4/95. He felt feverish but no temp was taken. On 6/21/95, 72 days post vax, he felt feverish, had severe arthralgia and shoulder pain radiating into the elbow (worse in right arm); hip pain again on 7/3/95. He self-medicated with aspirin. The investigator documented the hip and shoulder pain as mild and was unrelated to study vaccine. The investigator also documented severe myalgia in hips, shoulders and elbows which began on 5/25/95 that was moderate and was possibly related to study vaccine. The pain worsened and he was seen by his PCP and prescribed Relafen as needed and on unspecified date he prescribed prednisone. On 7/18/95 and 7/27/95, the investigator requested unblinding of the pt's treatment group because of progressively worsening pain. The investigator's assessment was neuro-muscular and he was referred to a rheumatologist which he saw on 8/3/95 and at that time, the pt reported back pain that radiated to his flanks. On 8/17/95, the pt reported to the investigator that his prednisone therapy had been stopped by his PCP who prescribed doxycycline 100mg X 2 daily and that the prednisone had been helpful and that his pain had worsened. That day, the investigator contacted the PCP who stated that she treated the pt due to his anxiety and felt that there was no clinical evidence of Lyme disease. Also, she felt that the pt could benefit from a mental health referral. After many visits to numerous physicians the pt's dx was thought to be fibromyalgia. This report has been classified as "Medically Serious". As of 5/8/01, the outcome of the events were unknown.