Age: 32.0
Sex: M
Vaccine: LYME
Symptoms: Joint swelling, Malaise, Purpura, Pyrexia, Sleep disorder
Clinical narrative: This report describes the occurrence of urticarial vasculitis in a 32 year old male who was vaccinated with recombinant OspA (LYMErix) for prophylaxis. This report was initially received directly from the subject's vaccine provider, then additional info received as part of litigation proceedings, with forwarding of medical records. Medical history included chronic urticaria of unknown etiology (beginning approximately April 1999), "dermatitis unspecified" (beginning 8/2/99), erythema multiforme, fungus, and Lyme disease with foot and joint pain. He reportedly felt weak right before breakouts. The diagnosis of Lyme disease was made on 8/30/99. The subject was treated with doxycycline 100mg twice daily from 8/9/99 to 10/1/99. The subject tested positive for the Epstein-Barr virus in August 1999. Surgical history included oral surgery NOS in 1990. The subject has no known drug allergies. He smoke sone pack of cigarettes per day. He does not consume alcohol. Family history included osteoarthritis (parents). The subject received a diphtheria tetanus vaccination on 6/12/99. The subject received his first injection of LYMErix on 10/1/99 (lot number given by physician as LY13099; however, please not that this is not a valid lot number). The physician reported that he had not seen or spoken to the subject since that time. The subject did not report any adverse events to the physician and did not return for further care or immunizations. In October 2001, the physician was notified as part of litigation proceedings that the subject experienced "persistent worsening of aches and pains" in the ankles and feet, "floaters" NOS, fatigue, and malaise. The subject reportedly claimed that these events were caused by LYMErix administration. In a Statement of Injuries, the subject's attorney alleged that the subject "suffers from intermittent and migratory joint pain and swelling (including his knees, hands, feet, shoulders, and arms), fatigue and urticarial rash exacerbated, prolonged, and otherwise affected by vaccination with LYMErix. The following was received from medical records: On 2/6/00, the subject presented to the ER with a chief complaint of "welts over entire body" for the previous two to three days. He gave a history of Lyme disease over a year ago that started as a rash and progressed to a flu-like illness, arthralgias, and malaise. The subject had received "double and triple doses" of doxycycline with no relief. Physical assessment revealed large areas of urticaria over the trunk, face and extremities, but was worse on the abdomen. He denied dyspnea or dysphagia. Pulse oximetry was 96% on room air. The subject had taken Benadryl and Tylenol prior to presenting to the ER. The physician prescribed Zantac and a tapering dose of prednisone. The subject was advised to stop all dietary supplements (he was reportedly taking multiple "nonregulated' dietary supplements) and to see a dermatologist or allergist. The subject was evaluated by a dermatologist on 2/7/00. At that time, the subject complained of a longstanding rash that had been coming and going to different extents for the past year. The rash was associated with itching and malaise. On physical examination, the physician noted a well-appearing male with widespread urticarial papules and plaques involving the face, trunk and extremities. The physician's impression was "chronic urticaria rule out vasculitis." The physician prescribed Periactin. According to the results of the skin biopsies of the arm and chest, performed on 2/7/00, the physician noted "I would regard this as a leukocytoclastic or urticarial vascultiis." Findings from immunofluorescence tests, performed on 2/9/02, were suggestive of lupus erythematosus. The subject was seen by his primary care physician on 2/8/00 with a chief complaint of hives. The subject was still getting a recurrent rash, his feet would swell, his temperature would reach 100 degrees F, and he felt weak and tired. The physician noted that the urticarial rashes may have been due to Biaxin, although he was last treated with the medication on 1/16/00 and the urticaria continued to persist. Upon physical examination, the physician noted erythematous slightly raised lesions that were mildly pruritic, and fading urticaria with a erythema multiforme appearance. The physician's assessment was "? urticarial vasculitis." The physician prescribed Zyrtec and Pepcid. The subject remained under the care of this primary care physician until at least 7/24/00. During this time, the subject experienced "flare-ups" periodically that were associated with swelling of the fingers and aching of large joints, feeling overtired, headache, and sleep disturbnaces. In addition, he developed Biberia in February 2000 which had "never cured" which was treated with Zithromax. The physician noted that there was an "apparent relationship between Zithromax and rash." During this time period, the physician prescribed Ceftin. The subject was seen by an immunologist on 11/2/00 for evaluation of multiple episodes of urticaria. Some of these episodes were associated with the use of antibiotics, at other times were occurring independent of antibiotic ingestion. The subject described his rash as hive-like and was extremely pruritic. He reported that Benadryl was "not terribly helpful," although Zyrtec had been helpful. On physical examination, the physician noted scattered hives on the subject's arms and scalp. He was also dermatographic. Penicillin skin testing was negative. However, the physician noted "unfortunately, this does not predict delayed-type reaction that many patients have. These reactions are not mediated by IgE antibodies and skin testing is not predictive of the appearance of this type of reaction." The physician added, "I do believe, after hearing the subject's story, that he is having chronic urticaria. I think that the antibiotics are perhaps the 'innocent bystanders' to his chronic urticaria." The physician prescribed Zithromax, Epipen, and suggested he use cetirizine hydrochloride on a twice daily basis for several days. As of 10/16/01, the pain in the ankles and feet was "persistent." The outcomes of the "floaters," fatigue, and malaise were not provided.