Age: 44.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Hypertonia, Polyarthritis
Clinical narrative: This report descrives arthritis symptoms in a *44 y.o.* male vaccinee who received Lyme disease vaccine recombinant Ospa. This report was received as part of litigation proceedings *with forwarding of medical records.* *F/UP report on 3/4/03: The medical history included allergy to chocolate, undescended testicle, hernia, hemorrhoids, scintillating scotomas, atypical URI, sinusitis, bronchitis, shingles (96), chronic fatigue (97), right lumbosacral sprain w/right sciatica (91), and bursitis of the right hip (91). In 1996, the vaccinee experienced visual disturbances, aches and pains in the back of his neck, and dizzy spells. The MD's assessment was "Stress w/psychophysiologic reaction." The vaccinee was hospitalized in 1997 w/paresthesias, headache, and a confusional episode. No Dx was recorded in the MD's office notes. Testing for HLA-DR4 antigen was negative. Surgical history included tonsillectomy (61), adenoidectomy (61), and correction of undescended testicle surgery and hernia repair (66). Concurrent medications included amoxicillin, alginic acid/ sodium bicarbonate/ magnesium trisilicate (Gaviscon), and omeprazole (Prilosec).* The vaccinee *received his 1st and 2nd injections of LYMErix on 9/10/99 and 10/7/99, respectively. On 2/14/02,* in a statement of injuries, his attorney alleged that the vaccinee "suffers from arthritis symptoms all over his body, including joint pain in his fingers and hands, and severe joint pain in his right shoulder." Time to onset following immunization, treatment, and outcomes of the alleged events were not reported. The adverse events "arthritis symptoms" and "joint pain" do not meet serious criteria, but are being submitted as an adverse event by special FDA per the June 28, 2000 letter. *The following info was obtained from medical records. The vaccinee telephone his MD on 2/2/00 and reported that he had experienced joint stiffening since receiving LYMErix. He requested to be tested for the presence of HLA-DR4 antigen. Testing on 2/9/00 was negative. Please see Lab Data section. The vaccinee returned to his MD on 2/17/00 because of constipation and possible weakening of a previous hernia repair (non-events). The vaccinee returned to his MD on 3/26/01 w/a chief complaint of recurrence of scintillating scotomas (non-event). "He is also concerned about some litigation concerning the Lyme vax. He has only 2 doses and ever since the 2nd dose his right shoulder has been markedly painful and he feels generalized arthritic stiffness in the morning and aches and pains throughout the day." No edema was noted in the extremities upon physical exam. The MD's assessment was probable ophthalmic migraines (non-event). Antinuclear antibody titer was elevated. Following the reported onset of arthritic Sx's, the vaccinee experienced hypercholesterolemia, constipation, bloating, intestinal gas, diarrhea, gastroenteritis, possible weakening of a previous hernia repair, probable ophthalmic migraines, and dysphagia. These events were not reported as adverse events due to vax admin, but were found during the course of review of the vaccinee's medical records. Therefore, they are not listed as events. The adverse events "arthritis Sx's", "joint pain", and "joint stiffening" do not meet ICH serious criteria, but are being submitted as an adverse event by special FDA request per the 6/28/00 letter. The vaccinee returned to his physician on 26 March 2001 with a chief complaint of recurrence of acintillating acotomas (non-event). "He is also concerned about some litigation concerning the Lyme vaccine. He has had only two doses and ever since the second dose his right shoulder has been markedly painful and he feels generalized arthritic stiffness in the morning and aches and pains throughout the day." No edema was noted in the extremities upon physical examination. The physician's assessment was probable ophthalmic migraines (non-event). Antinuclear antibody titer was elevated. Following the reported onset of arthritic symptoms, the vaccinee experienced hypercholesterolemia, gastrointestinal pain relieved by belching, constipation, bloating, intestinal gas, diarrhea, gastroenteritis, possible weakening of a previous hernia repair, probable ophthalmic migraines, dysphagia, upper respiratory infection, toothache, and tooth extraction. These events were not reported as adverse events due to vaccine administration, but were found during the course of review of the vaccinee's medical record. Therefore, they are not listed as events. The most recent information, received on 21 May 2003, did not provide the outcomes of the reported events.  The most recent information, received on 23 April 2004 revealed that the patient presented to his physician on 11 June 2003 with complaints of left hip pain of 10 days duration. (He had a hisotry of joint pain dating back to 1995). Physical examination revealed pain with palpation over the greater trochanter. He also experienced pain with flexion and extension and internal and external rotation of hip joint. No crepitus was noted. X-ray performed that same day showed moderate narrowing of the superior and medial portions of hip joint space without spurring or sclerosis. The changes were "nonspecific and could represent either rheumatoid or osteroarthritis. The bones appear well minieralized and no soft tissue calcifications are seen."