Age: 52.0
Sex: M
Vaccine: LYME
Symptoms: Lymphadenopathy, Nasal congestion, Pain, Pharyngitis, Pharyngolaryngeal pain
Clinical narrative: This report describes joint pain and swelling in a 52 year old male who received Lyme disease vaccine recombinant. This report was received as part of litigation proceedings, with forwarding of medical records. Following the reported onset of fatigue, the vaccinee experienced pharyngitis, "mild" blepharitis of both eyes, "mild" inferior follicular reaction of both eyes. These were not reported as adverse events due to vaccine administration, but were found during the course of review of the vaccinee's medical records. Therefore, they are not listed as adverse events. The vaccinee received injections of LYMErix on 03/05/1999, 04/06/1999 and 03/10/2000. In a statement of injuries, his attorney alleged that the vaccinee "suffers from joint pain and swelling, and a loss of strength in his arms. In addition, he has suffered from fatigue and fevers." Medical records from the vaccine provider did not record any adverse experience following receipt of the first injection of LYMErix. The vaccinee was seen by his physician on 04/19/1999. 13 days following receipt of the second injection of LYMErix, reporting that he "had high BF at work-feels tired." The physician's assessment was borderline hypertension. The vaccinee did not return to the physician until December 1999. There was no mention of fatigue, fever, joint pain or swelling, or loss of strength. The vaccinee returned to his physician on 05/30/2000, two months following receipt of the third injection of LYMErix, with chief complaints of coughing, "sinus drip," fever, and fatigue. On physician examination, the physician observed post-nasal drip and congestion. A diagnosis of sinusitis was made, and the physician prescribed clarithromycin, promethazine with codeine syrup and vitamin B12. The vaccinee returned to the physician on 06/02/2000 to have his blood pressure measured; no complaints were recorded. The vaccinee was seen by the physician on 06/05/2000 due to a sore throat. A diagnosis of cervical  lymphadenopathy was made and the physician administered vitamin B12. The vaccinee had his blood pressure measure on 06/12/2000, 06/21/2000, and 05/08/2001; no complaints were recorded on these visits to his physician. The vaccinee returned to the physician on 08/06/2001. 17 months after the third injection of LYMErix, with chief complaints of "headache, achy, diarrhea, multiple joint pains." On physical examination, the physician observed "post-nasal drip, joints-no swelling or pain." The physician's assessment was "sinusitis, arthritis." He prescribed clarithromycin and administered vitamin B12. On 08/07/2001, antinuclear antibody titer and rheumatoid factor were negative, uric acid concentration and erythrocyte sedimentation rate were within the reference ranges, and total cholesterol was elevated. On 10/22/2001, Lyme IgG ELISA was above the reference range; Lyme IgG and IgM western blots were negative. The overall interpretation of Lyme serology was reported as "no evidence of seroreactivity beyond that expected from the Lyme vaccine." Outcome of the reported events were not provided. The adverse events "joint pain," "joint sweling," and "loss of strength" do not meet serious criteria, but are being submitted as an expedited report by special FDA letter. The most recent information received on 16 September 2003, did not provide the outcome of the reported events.