Information has been received from a employee health nurse concerning a 48 year old female who on 24-MAR-2008 was vaccinated with a first dose of RECOMBIVAX HB and developed Lichen Planus after vaccination. On 18-APR-2008, she was seen in the emergency room for a rash but was not admitted to the hospital. On 24-APR-2008, the patient was vaccinated with a second dose of RECOMBIVAX HB. At the time of the report, the patient had not recovered. Follow-up information has been received from a registered nurse and medical records concerning this overweight, 48 year old female house keeping aide with TORADOL, FENTANYL, PENICILLIN, MORPHINE (rash) and latex allergies and chronic pain with degenerative joint disease, hyperlipidaemia, constipation, vasomotor instability, sleep disturbance, cat bite on her hand, fatigue, depression and smokes 1/2 PPD and a history of drug abuse, total knee replacement and staple gastropathy (1981) who on 24-MAR-2008 was vaccinated IM in the deltoid with RECOMBIVAX HB (lot # 657681/1371U). The patient received the second dose of RECOMBIVAX HB on 24-APR-2008 IM in the left deltoid. Concomitant therapy included EFFEXOR, CELEXA, MOTRIN, vitamin B (unspecified) and PERCOCET. Medical records dated 18-APR-2008 indicated that the patient was seen in the emergency room for evaluation regarding nonspecific dizziness, lightheadedness, cough, upper respiratory congestion and a tingling sensation in her arms. The patient stated that she had some difficulty with bruising on her arms and legs and a minor rash on her arms. The patient denied known exposures. It was noted that the patient had recent upper respiratory symptoms, coughing and congestion. The patient complained of headache that started yesterday and slight confusion. Disorientation was noted. The patient also complained of "pricky feeling" in cheeks and bilateral arms. 2-3 + edema was noted bilateral lower extremities and 2 + edema noted bilateral hands and forearms. Petechiae was noted to the torso and abdomen. The patient's face was flushed. The patient had a CBC and chemistries drawn. The results were unremarkable. She was diagnosed with nonspecific viral syndrome, dizziness and lightheadedness. The patient was given BENADRYL 50 mg orally. Plan: TYLENOL and ibuprofen Q4H as needed. The patient was told to increase fluids and follow-up as necessary. The patient was discharged home. Medical records dated 25-JUN-2008 indicated that the patient was seen because of an itchy spreading rash that had developed on her feet, legs, wrist and forearms over the past month (approximately 21-MAY-2008). The rash had not cleared up with the use of BENADRYL or with 1% hydrocortisone cream. Physical examination revealed the presence of polygonal, 3 mm sized, reddish-purple, flat-topped papules on the patient's dorsal feet, anterior legs, flexor wrist and forearms, and extensor forearms. There were no other significant cutaneous abnormalities on the scalp, face, mouth, ears, neck, chest, back, fingernails and toenails. She was diagnosed with lichen planus. Plan and instructions included: CLOBETASOL 0.05% ointment BID to the rash for 2 weeks, HYDROXYZINE HCL 25 mg, PO, 1 hour before bed, PREDNISONE 20 mg, PO, BID for 4 consecutive days, after she had been off of her DOXYCYCLINE capsules and after she is assured that the cat bite on her had has healed. The patient to call the physician in 2 weeks if the rash and itching was not considerably better. Medical records dated 23-JUL-2008 indicated that the patient was seen for a painful rash. It was noted that the patient returned because the rash on her extremities had spread and worsened. The patient reported that she had noticed some white patches inside her mouth. The patient reported that being on her feet seemed to aggravate the rash, and she has had swelling and blistering of the bottoms of her feet over the past week. The patient reported more pain than itching. Physical examination revealed the presence of an increased number of erythematous, polygonal, flat topped, 2 to 3 mm sized papules on the patient's extensor forearms and anterior legs. There were some lacy white patches present on the buccal mucosa, but no sign of any ulceration of blistering in the mouth. There was some mild erythema and swelling on the plantar surfaces of her feet and toes, but no actual blisters or fissures were seen. The rest of the skin examination on the scalp, ears, face, neck, chest, back, arms and thighs showed no new significant cutaneous abnormalities. She was diagnosed with lichen planus, unresponsive to topical and systemic steroid therapy. Plan: discontinue CLOBETASOL ointment, start Methotrexate 5 mg, PO, 3 times a week on Thursday being mornings with breakfast, Thursday evenings with supper, and Friday mornings with breakfast for the next 2 weeks, BETAMETHASONE DIPROPIONATE 0.05% ointment BID to the forearms and legs, the patient discontinued HYDROXYZINE HYDROCHLORIDE, which she does not feel has been helping, return in 2 weeks for a recheck visit and further laboratory tests. Patient to be excused form work for the next 4 days because of the pain. Medical records dated 05-AUG-2008 indicated that the patient was seen for a itchy rash. The patient reported that all of the spots were improving, and she was not getting any new spots. The patient felt she still had a long ways to go. The patient was able to return to work with some discomfort, which she has been able to tolerate very well. Physical examination revealed the presence of a decreased number of purplish papules on the patient's trunk and forearms, but they were still quite extensive and large on the dorsal feet, ankles and legs. The largest spot measures approximately 1 cm on the patient's right medial leg. No skin lesions were seen today on the scalp, face, ears, neck and hands. The patient had some horizontal ridging of all of her fingernails, which appears to have occurred approximately 2 months ago. She also had some marked dystrophy and probable onychomycosis of her great toenails. Both of these toenails wee surgically removed at 1 time because of their thickening. She was diagnosed with lichen planus, improved but was still active. Plan: continue METHOTREXATE 5 mg, PO, 3 times a week at 12 hour intervals on Thursday morning, Thursday evening, and Friday morning as before, discontinue BETAMETHASONE ointment, start HALOBETASOL ointment BID to the problem areas on the wrists and legs, follow-up in 1 month and patient may return to work. Medical records dated 03-SEP-2008 indicated that the patient was seen for a skin rash. The patient reported that the skin rash on her trunk, and extremities had improved markedly since her last visit. All of the itching had resolved and all of the spots had been slowing decreasing in size and number. The patient had not noticed any new spots developing on her skin over the past month. The Patient also reported that the HALOBETASOL ointment seemed to be helping to clear up the spots which seems to involve all of her joints except her elbows as well as low-grade fever and nausea that she has had on and off for the past 2 weeks. The patient has no family history of any collagen vascular disease. Physical history revealed the presence of a decreased number of purplish, polygonal, scaling, flat topped papules on the patient's leg, ankles and feet while the chest, back, abdomen, forearms and hands are almost completely clear. No new skin lesions were seen on the face, scalp, ears or neck. She was diagnosed with lichen planus, markedly improved, rule out collagen vascular disorder and also rule out any drug hypersensitivity reactions. Plan: continue current dose of METHOTREXATRE 3 times a week for lichen planus, continue HALOBETASOL ointment 0.05% BID to the spots on the legs and feet, follow-up in approximately 6 weeks to recheck lichen planus. The patient was instructed to see her family physician for her symptoms of fever, nausea, joint and muscle pain if not considerably better over the next week. Medical records dated 01-OCT-2008 indicated that the patient reported that she received ROCOMBIVAX HB vaccine and developed a rash that started on her legs and started extending to her lower extremities and arms. The patient reported that she got the second ROCOMIVAX HB vaccine and it seemed to worsen. The patient was seen by a dermatologist, who diagnosed her with lichen planus and gave her METHOTREXATE. Since then, symptomatology has worsened and since June or so, she had generalized body aches in knees, hips, right shoulder, neck, lower back with myalgias and generalized fatigue. Despite this, the patient continues to work daily. The patient was evaluated with an autoimmune cascade that was negative x 2, a lyme screen that was positive and a lyme western blot that was negative. The patient was treated with DOXYCYCLINE for 2 weeks with no response, and was hospitalized for a couple of days and received CIPROFLOXACIN for unknown reason. On 18-SEP-2008, the patient was seen by her family practitioner, who thought the patient had Lyme disease. The patient reported having areas of hypoesthesia on her fingers and her arms that are not improving. Physical examination revealed the patient's neck was tender to palpation, extremities with multiple skin lesions, small patches of erythematous, elevated scaly lesions, mildly tender in most of the lower extremities. There was definitively evidence of some edema of the metacarpophalangeal joints in both hands. She was diagnosed with acute polyarthritis syndrome with likely a false positive lyme test, and possibly reactive arthritis related to ROCOMBIVAX HB vaccination. Discussion: The patient looked uncomfortable. The joints do look inflamed, though her inflammatory markers are all normal. Her CRP in the office was 0.8. The possibility of a seronegative rheumatoid arthritis, but that would be very unlikely. Reactive arthritis type picture from ROCOMBIVAX HB vaccination or autoimmune complex disease associated with the ROCOMBIVAX HB vaccine should be strongly considered, though again, there were no obvious involvement of any organs. The Lyme western blot was negative, and unless it is a very acute Lyme with early negative antibodies, this is unlikely. The patient received around 14 days of DOXYCYCLINE with no improvement whatsoever. At this time, it was suggested to stop the CIPROFLOXACIN, and start the METHOTREXATE as she had done, and try some PREDNISONE and some antiinflammatory agents for the next 7-10 days. The patient was given a prescription for PREDNISONE 30 mg and follow-up in around a week. If symptomatology improves dramatically, the patient nay be weaned off of the steroids and see how she does. On the other hand she may have to send her to Rheumatology. Medical records dated 08-OCT-2008 indicated that the patient was seen for follow-up. It was noted that the patient was seen a week ago with diffused body aches, myalgias, arthralgias, weakness, night sweats and a positive lyme screen but negative Western blot. The patient received 14 days of DOXYCYCLINE and another 14 days of CIPROFLOXACIN with no relief whatsoever. Initial evaluation was that the patient either had post-immunization arthritis or rheumatoid arthritis picture. After evaluation the patient was started on PREDNISONE 30 mg daily. The patient reported feeling at least, if not more, 50% better. The joint pains and stiffness had improved. The patient's only Physical examination showed acute onset of night sweats at nigh time and inability to sleep well. Physical examination showed increased mobility in all the joints and the neck was not stiff like it was before. The metacarpophalangeal joints, especially the second and third, still looked edematous, especially on the right, though they were improved and there was a suggestion of ulnar deviation on the right hand. The patient was diagnosed with Reactive arthritis versus rheumatoid arthritis seronegative. Plan: wean patient off PREDNISONE 5 mg every 3 days until she gets to around 10 and send patient to see another physician. Check x-ray of the hands. The patient's adverse events ere considered disabling. Additional information is not expected. All available medical records will be provided upon request.