Age: 48.0
Sex: M
Vaccine: LYME
Symptoms: Pain in extremity, Paraesthesia, Rash, Shoulder pain, Speech disorder
Clinical narrative: This report described the occurrence of flu-like symptoms in a 48 year old male pt who received Lyme disease vaccine (LYMErix) for prophylaxis. This report was received as part of litigation proceeding. The pt submitted a report directly to VAERS. Medical records were subsequently provided. On a VAERS form completed by the pt on 3/13/03, he indicated that he received an injection of LYMErix n 3/13/99. The pt indicated that his adverse experience began on 3/14/99. For the description of the event, he wrote, "flu like symptoms, headaches, neck pain, stiff neck, shoulder  pain, joint pains, joint problems, numbness, difficulty in pronouncing words, pain in knees, arms, lost of balance, dizziness, foot pain." He indicated that he had sought medical attention for these events and that the outcome of these events was "Unknown." On 9/3/03, the pt's attorney stated, "Vaccinations occurred on 3/13/99, 4/17/99, 3/11/00 and 7/2/01 according to the client." The pt, therefore, received a fourth dose of LYMErix, which is not recommended. The attorney alleged that the pt "suffered joint pain and swelling, flu-like symptoms, fatigue, rashes, tingling of his hands, arms, feet and toes, numbness, headaches, foot pain, numbness of his teeth and jaws, difficulty speaking, difficulty biting down, insomnia, nervousness, irritability, chest pain and decreased libido after the first vaccination according to the client." Treatment and outcomes of the alleged events were not reported. The following info was provided via medical records. Medical history included chronic hep B, an "old" cervical spine injury, chest pain, Crohn's disease, and ulcerative proctitis. Medical records confirmed that the pt received LYMErix vaccinations on 3/13/99, 4/17/99, 3/11/00 and 7/2/01. No adverse events were specifically recorded in the medical records provided after any of the doses of LYMERix. On 2/22/00, the pt presented with flu-symptoms starting the preceding day, including sinus pressure, headache, stuffy nose, and yellow/ green nasal discharge. Treatment included Cefzil, Claritin, and fluid intake. Approximately six months later, the pt reported to his physician by telephone that he was experiencing dizziness, and urinary frequency and burning. Ampicillin was prescribed. In July 2001, the pt was examined for complaints of stiff neck, nausea, swollen glands, and headache. The pt thought that he had been bitten by a spider. Ceftin was prescribed. In January 2003, the pt was evaluated for a chief complaint of Lyme symptoms including a stiff neck, achiness and dysarthria. On 1/16/03, he complained of stiff neck, dull headaches, loss of balance when walking and pain and tightness in his jaw, which was associated with a root canal performed 12/18/02. The pt had undergone a hernia repair in the same month. .A diagnosis of "Lyme" was indicated on 1/30/03, and treatment with doxycycline was initiated. However, the pt was evaluated by an infectious disease physician, whose stated impression was tht the pt did not have Lyme disease, as evidenced by negative serologic testing on the more specific Western blot test. The physician stated that the positive ELISA was likely due to the pt's LYMErix vaccinations. Following the reported onset of flu-like symptoms, the pt experienced anxiety, palpitations, sinusitis, testicular pain, and genital herpes simplex virus. These were not reported as adverse events due to vaccine administration, but were found during the course of review of the pt's medical records. Therefore, they are not listed as adverse events. The most recent info received on 12/8/03 did not reveal the outcome of the reported adverse events.