Age: 51.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Arthritis
Clinical narrative: This report describes osteoarthritis in a *51 y.o. male who was vax'd with Lyme disease vax recombinant* (LYMErix). This report was received as part of litigation proceedings *w/forwarding of medical records. The subject's medical history included allergies to erythromycin, trimethoprim / sulfamethoxazole (Bactrim), and aspartame (NutraSweet). The medical history included tick bite followed by pain in the right shoulder and both hips (89), Lyme disease, arthritis (89), congenital deformity of the right hip associated w/developmental degenerative arthritis, bilateral rearfoot varus deformity w/excessive subtalar joint pronation, bilateral enthesopathy w/metatarsalgia, bilateral exostosis of the dorsal first metatarsal-cuneiform joint, contraction and planar deviation of the 2nd and 3rd digits of the right foot, pes planus treated w/orthotics, stress fracture of an ankle (88), skiing injury to the left shoulder (96), bursitis of the left shoulder (97), bacterial folliculitis, dermatofibromas, acne, acrochordons, seborrheic keratosis, basal cell carcinoma, compound Clark's nevus, epidermal inclusion cyst, hypercholesterolemia, increased concentration of total bilirubin, chest pain (96), sinus bradycardia (91), incomplete right bundle branch block (91), nonspecific ST-T wave changes (93), premature ventricular contractions (91), varicose veins (98), hiatal hernia, and corneal abration. Surgical history included excision of epidermal inclusion cyst (81), excision of basal cell carcinoma (96), tonsillectomy and adenoidectomy as a child, vasectomy (84), and eyelid reduction (91). Concurrent medications included famotidine (Pepcid), enteric-coated aspirin (Ecotrin), calcium lansoprazole (Prevacid), multivitamins, and antioxidants. The subject received injections of LYMErix on 6/7/99 and 7/12/99. He declined the 3rd injection. On 2/11/02,* in a statement of injuries, his attorney alleged that the vaccinee "suffers from joint pain, in particular in his hip and elbow. He also experiences pain in his right leg. In addition, he suffers from osteoarthritis in his right hip." Time to onset following immunization, treatment, and outcomes of the alleged events were not reported. The adverse events "osteoarthritis" and "elbow pain" do not meet serious criteria, but are being submitted as an expedited report by special FDA request. *F/UP report on 3/4/03: The following info was obtained from medical records. The subject presented to an orthopedist on 8/11/99 "for evaluation of pain in his right leg." At that time, the subject "reports that he has been training for an upcoming high altitude hiking and hunting trip in Sept. In doing so, he was carrying a 50-lb sandbag in a bag which he has been doing for 1.5 months. He noted the onset of discomfort involving his right hip on 7/20/99. This progressively worsened, causing him to stop his training regimen. The PT began experiencing pain extending down to his right leg to the level of the knee. He does report that stair climbing causes him significant discomfort. He does report 3 episodes of a shock-like pain radiating into his right calf and foot. The PT has been performing stretching exercises and taking Advil (ibuprofen) which he reports partially relieves his Sx's. He had no pain while sitting and only occasional trouble while sleeping. He notes that the use of a whirlpool markedly worsened his Sx's. He has experienced cramping in his calves on occasion. He also notes that with walking his knee occasionally gives way and he has had a "flushing" sensation in his entire leg on occasion." On physical exam, the orthopedist noted that the subject "ambulates w/an antalgic gait. Increased thoracic kyphosis is present. Lumbar lordosis is normal. No paraspinal muscle tenderness is noted in the lumbosacral region. Excursion of the lumbar spine is normal. No tenderness is noted over the sacroiliac joint. The sciatic notch is non-tender. No tenderness is noted over the iliac crest. Mild discomfort is noted in the right abductor region. The greater tronchanter is non-tender. Hip range of motion includes 100 degrees of forward flexion, 20 degrees of extension, abduction to 40 degrees, and internal and extrenal rotation symmetric to the contralateral extremity and not associated w/discomfort. Resisted hip flexion and abduction is associated w/only mild discomfort. Straight leg raise testing is equivocal. No thigh atrophy is present. Knee and ankle range of motion are normal. Neurological testing of the lower extremities reveals 5/5 motor strength, normal sensory function, and deep tendon reflexes were 2+ and symmetric at the knees and ankles. X-rays of the lumbar spine reveal there to be degenerative disc changes at the L5-S1 level with disc space narrowing. No other bony abnormalities are present. Radiographs of the pelvis reveal there to be a flattening of the right femoral head and mild coxa vara, not associated w/narrowing of the articular space." The MD' simpression was "Right leg pain. The differential Dx's include strain of the right hip, symptomatic congenital dysplasia of the hip versus lumbar radiculopathy." The MD prescribed indomethacin (Indocin) and physical therapy. The subject remained the care of this orthopedist until at least 1/16/02. During this time, the reported that he experienced no significant relief of his Sx's w/physical therapy. He had increased pain during stretching and strengthening activities. He reported "minimal relief" w/methylprednisolone therapy, but that he was "doing well" w/therapeutic injection of the hip. On 4/5/01, the subject reported 9-month history of pain involving the medial aspect of the right elbow that was worsened w/activities, particularly chin-ups. On 1/16/02, he reported a several month history of left shoulder pain causing difficulty reaching in the overhead position. During this time, the orthopedist noted a normal carrying angle of the right elbow; no swelling or deformity of the right elbow; point tenderness over the right emdial epicondyle that was worsened w/resisted flexion of the wrist and fingers; positive Tinel's sign over the right cubital tunnel w/negative acute flexion testing; no swelling, atrophy, or deformity of the left shoulder girdle; no tenderness at the left acromioclavicular joint; "mild" tenderness in the left impingement area; full left shoulder range of motion; negative apprehension, relocation, Labral, and biceps tensioin tests; "mildly" positive impingement test in adduction but not forward flexion; and "mild" discomfort on left rotator cuff testing. X-rays of the pelvis performed on 4/5/01 "reveal congenital deformity of the hip. There is coxa vara and superior joint space narrowing w/subchondral sclerosis suggestive of a moderate degenerative arthritis." X-rays of the left shoulder performed on 1/16/02 "reveals there to be early degenerative changes at the left acromioclavicular joint." Add'l Dx's made by the MD included "trochanteric bursitis about his right hip" (8/18/99), "persistent right groin and thigh pain which appears to be associated w/a congenital deformity of his right hip along w/early degenerative arthropathy" (8/25/99), "Congenital deformity right hip associated w/developmental degenerative arthritis" (4/5/01), "Medial epicondylitis right elbow" (4/5/01), and "Asymptomatic degenerative arthritis at the left acromioclavicular joint with inferior directed spur and mild impingement syndrome" (1/16/02). The MD prescribed a rapidly-tapering course of methylprednisolone (Medrol Dosepak), intra0articular corticosteroid injections, and physical therapy. The subject was referred to an anesthesiologist practicing pain medicine for intra-articular injections. As of 1/16/02, the hip pain "seems to be well managed w/intermittent corticosteroid injections and use of Celebrex [celecoxib]." Left shoulder pain persisted. The outcome of the right medial epicondylitis was not specified. The subject presented to the anesthesiologist on 9/1/99 for right hip injection. At that time, the subject reported "a history of dog sledding across the Arctic Circle which produced a significant amount of axiam pounding of his hips and back. After this, he developed right hip pain." The anesthesiologist administered the following right hip intra-articular injections: ropivacaine and triamcinolone, 9/19/99; mepivacaine and betamethasone (Celestone), 9/15/99; ropivacaine and betamethasone, 4/3/01; ropivacaine and triamcinolone, 7/10/01; and ropivacaine and triamcinolone, 11/1/01. On 10/29/99, the subject reported "complete resolution of his pain". On 5/14/01, he reported "excellent reduction in his Sx's for his trip to another state. He states 50% reduction of pain overall." On 3/26/01, he reported "some reoccurrence of his SXs." The subjelct presented to the vax provider on 10/9/99 w/a chief complaint of left his pain. The MD noted "Went on a very rigorous hunting trip in another country. As he was getting prepared for the rigors of the trip, carrying a 50-lb knapsack on his back, he aggravated his right hip, saw [an orthopedist], and it injected. On the trip it slowly got better, had developed left sciatic pain. Did have MRI of his back. There were no herniated discs at that time." The MD prescribed celecoxib (Celebrex), carisoprodol (Soma), and famotidine (Pepcid). Lab analyses revealed increased total Lyme antibodies w/negative IgG and IgM Western blots. Please see Lab Data section. The subject remained under the care of this MD until at least 1/15/02. On 8/1/00, the subject reported that the arthritis of his right hip "has been doing well w/Celebrex [celecoxib] along with glucosamine and chondroitin." On that date, he also reported left shoulder pain w/movement. During this time, the subject also reported aching around the right knee when walking, which the subject did not "feel it is his knee itself." The MD noted extensive, painful varicose veins around the right knee. No crepitus of the knee was noted on physical exam. MRIs revealed abnormalities. Please see Lab Data section. The MD made DXs of "arthritis of the hip" (5/31/00), "probable bursitis of the left shoulder" (8/1/00), and "osteoarthritis of shoulder, knees" (1/15/02). The MD prescribed famotidine (Pepcid). The MD referred the subject to an orthopedist, physical therapist, and rheumatologist. The subject was evaluated by a rheumatologist on 7/27/00 because he "was concerned of a Lyme vax reaction." At that time, the subject reported that 1 wk after he had received his 2nd LYMErix injection, he developed pain in his right hip. On review of systems, the subject denies "fevers, rashes, chest pain, eye, oral lesions, Raynaud's, photosensitivity, dysuria, dysphagia, peripheral joint swelling, morning stiffness other than the right hip, low back pain, psoriasis, or colitis. About 1.5 wks ago he develope some discomfort involving the left shoulder but this is slowing resolving. Approx 3 days ago he noticed several tick bites. The ticks were on him for about 4 hrs and they were removed. Now he has several bites on his skin at the location of these bites. He does not express any headaches, fevers or fluid like illnesses [sic]." Medications at the time of the evaluation included famotidine, celecoxib, enteric-coated aspirin, calcium, glucosamine, and chondroitin. On physical exam, the MD noted "no definite swelling in the hands, wrists, knees or ankles. Full ROM of both shoulders. Full cervical spine mobility. Dorsal kyphosis present w/barrel chest appearance. Normal LS [lumbosacral] spine flexibility w/slight scoliosis. Full hip to almost 90 desgrees. Extremities: no edema. Skin iwith 3 small insect bites noted over the left buttock and upper thigh area. No bull's-eye rash or other rash noted." The rheumatologist's impressions were "1) His asymmetric joint pain would not be typical for rheumatoid arthritis. I do not have enough evidence to implicate a Lyme vax as a cause of his present joint complaints... He could have simply had an episode of synovitis involving the right hip. He may have some old degenerative disease about the right hip. Doubt aseptic necorsis. 2) Doubt active Lyme disease, recent tick bites but no rash, systemic SXs." The subject requested testing for the HLA-DR4 antigen. "PT was advised that a DRW4 positive test would simply indicate an increased risk of having active arthritis and would not necessarily substantiate a claim that a Lyme vax caused his joint SXs. Also the fact that his Sxs are asymmetric and not symmetric would go against a vax type of reaction." The rheumatologist recommended continuation of famotidine and celecoxib therapy. Lab analyses revealed the presence of HLA-DR4. Please see Lab Data section. Following the reported onset of osteoarthritis, the subject exxperienced a cyst on the left mandible region, right and left inguinal hernias, right inguinal hernia repair (March 00), right ulnar neuropathy, pharyngitis, nocturia, prostate nodule, erectile dysfunction, and multiple tick bites. These events were not reported as adverse events due to vax admin, but were found during the course of review of the subject's medical records. Therefore, they are not listed as adverse events. The most recent info, received on 9/26/02, did not provide the outcomes of the reported events.*