Age: 56.0
Sex: M
Vaccine: LYME
Symptoms: Demyelinating polyneuropathy, Dry mouth, Fatigue, Hepatitis C antibody negative, Musculoskeletal stiffness
Clinical narrative: This case was reported by a lawyer and described the rheumatological symptoms in a 56 year old male patient who receieved LYME disease vaccine recombinant OspA (LYMErix) injection for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date, the patient received LYMErix. At an unknown time after receiving Lymerix, the patient experienced " rheumatologic and neurologic complaints" Time to onse, treatment and outcome were not reported. On 17 April 2006, a statement of injuries was received from the law firm representing the subject. It was reported that the subject suffers and has suffered from joint pain and swelling, fatigue, tingling in extremities, and decreased activities of daily life. In addition, subject suffers from rheumatolgic, neurologic and/or cognitive impairment of an autoimmue, immune-medisted, or other methaniam, all reportedly caused by vaccination with LYMERIX. Future expedited VAERS reports for this LYMERIX case shall be referenced to BD-IND 5426, which is a change from past reports referencing the voluntarily-revoked license (STN 103757). Follow-up was received via medical records on 30 November 2006. The subject's medical history is notable for right hand dominance, hypertension, left carpal tunnel release and left ulnar nerve release to treat EMG-validated pedian nerve disease, left handed tenderness over the 2nd and 3rd A-1 pulleys with slight weakness in the intrasic 1st dorsal. Interoxious and abduction of the 5th finger (onset 1998). On 25 October 1997. Lyme disease antibody was negative. The subject had no known drug allergies. The subject has one drink per day. Family history is notable for multiple sclerosis in the subject's paternal grandmother. The subject's concurrent conditions were not reported. On 19 February 1999, the subject received the 1st dose of LYMERIX in the left upper arm. On 16 March 1999, the subject received the 2nd dose of LYMERIX in the left upper arm. On 07 July 1999, approximately 113 days after the 2nd dose of LYMERIX, the subject experienced left knee pain and was seen by a physician. The subject mentioned to his physician that he had been climbing a lot on the ladder. The subject subsequently experienced left hand 2nd finger pain and swelling. On 11 July 2000, an x-ray of the 2nd finger of the left hand showed soft tissue swelling with no evidence of intrinaic ennaous disease process. The subject subsequently experienced pain in his hands and feet with morning stiffness, joint  tenderness and pain over the  small joints. On 27 June 2002, laboratory analysis indicated a normal erythrocyte sedimentation rate and negative results for Lyme infection, Rhematoid Arthritis factor and antinuclear antibodies. In January 2003, the subject was diagnosed with neronegative rheumatoid arthritis. The subject was treated with prednison, methotrerate, ARAVIA, and HUMIRA. On 21 October 2003, x-rays of both feet revealed tiny left and small right calcanal sports with mild osteoarthritis in both feet. The subject was seen by a physician on 08 December 2003 and was diagnosed iwht paripheral neuropathy over the feet related to chronic synovitis. The subject was then treated with TARKA, bextra, VOLTARAN, NEURONTIN and aspirin. On 24 April 2004 laboratory analyses for homgenous antinuclear antibodies. An-DNA (double-stranded). RNP andtibodies, Smith antibodies, Sjorgren's Anti-SS-A (and, anti-SS-B), Anti-neurophil cytoplamic and antibody lachemia of the toes. In October 2004, the subject was seen by a nerologist. Neurological examination was wasting and fasciculation. Romberg sign, tendem imbalance, and hypoactive reflexes. Electromyigraph and nerve conduction studies of the legs and arms were notable for unobtainable ulnar aenory response constant with chronic inflamatory demyolinating plyneurophy. The neurologist considered the subject to have chronic intravenous immunoglobulin. The outcome of the events was not reported. Follow-up information was received on 24 January 2007 via medical records. According to primary care physician's notes dated 15 May 1998, the subject had a history of osteoarthritis with associated weakness. In January 2004, the subject presented with increased pain and changes of the color of his toes, and was diagnosed with bilateral lachemia in the toes (notes indicated "rule out secondary to peripheral vascular diseases, rule out vasculitis due to rheumatoid arthritis") Mild synovitia and diminished hand grip strength were also noted. He was also diagnosed with onset of Raynaud's phenomenon. In July 2004, the subject was "doing a little bit better" with mathotrexate and Enbrel. The physician expressed a "major concern" that his ANA because positive, which might require discontinuation of Enbrel. Enbrel was later discontinued. In a letter dated 02 December 2004, the subject's physician reported an impression of seronegative rhematoid arthritis, with reactivation of the disease after recent discontinuation of methoprexate and Bextra. The physician also noted evidence of chronic denyslinating ployneuropathy without observed significant neurological deficit. According to a progress note dated 10 February 2005, the subject experienced difficulties with walking due to severe Raynaud's phenomenom, which remained "very active". Plaquenil was added to threapy including Enalapril. Procardia, methotrexate, Daypro, and leukovorin, and the physician stated " I strongly support his claim for disablity". Assessment inclueded chronic demyelinating polyneuropathy of unclear etiology. Very severe Raynaud phonomenion, and elevated erythrocyte sedimentation rate of unclear etiology. In april 2006, the subject continued to and elevated erythrocyte sedimentation rate of unclear etiology. In April 2006, the subject continued to experience increased pain and swelling in his hands with more stiffness, and complained of more parethesis with burning and shooting pain in his upper and lower extremities. The subject's rhematoid arthritis was assessed as "not well controlled in spite of being on ARAVA AND inothotrexate". The subject was seen for follow up of rheumatoid arthritis on 06 June 2006, and reported no change in joint pain with swelling that was "a little bit better". Evaluation revealed mild fatigue, and medications at the time included methotrexcate and prednisone. Impression was of seronegative rheumatoid arthritis not fully reponding to multiple medications, Raynaud's phenomonon "under better control", and demyelinating polyneuropathy that did not respond to intravenous immunoglobulin. The subject declined a nerve biopsy. Follow-up informatin was received on 16 April 2007 via SSA records. According to SSA claim determination dated 13 October 2005, the subject alleged rhematoed arthritis, and supporting records indicate "active disease". It was noted that the expectation was "that the disease will remaiin active despited prescribed treatment", resulting in approval of his claim for impairment. Supporting documentation accompanying the SSA claim included the progress note dated 10 February 2005, which indicated active rheumatoid arthritis. At that time, the reporting physician stated " I strongly support his claim for disablity". Impression included chronic demyelinating polyneuropathy of unclear etiology, and it was noted that synetitis had not improved at that time. Additional supporting doucmentation included a progress note dated 21 March 2005, at which time the subject was seen for follow-up of rheumatoed arthritis, He reported increased foot since initiation of IVIG, and that Plaquenil had not been "helpful". He indicated that he was unable to work due to medical problems, including pain and swelling with stiffness in his joints. On that date, he was reportedly positive for Raynaud's phenomenon, and was positive for paresthesias in the hands and feet. Impression was of "so far poorly controlled" neronegative rhematoed arthritis, sever Raynaud's phenomenon, and ployneuropathy. He was re-evaluated on 18 April 2005 and was reported to be "doing a little bit better". Impression at that time included seronegative rheumatoid arthriits, "rule out vasculitis given the fact that he has demyelinating ployneuropathy", "more active" Raynaud's phenomenon, and positive antinuclear antibody due to Humaria. Follow-up information was received on 27 April 2009 via medical records. The subject was seen regulary for follow-up of his rhematoid arthritis. On 14 February 2006. It was reported that his disease had been stable. He still had some swelling, pain and stiffness in his hands, but it wasn't as bad. His Raynaud's phenomnon was also stable. Paresthesia in the upper and lower extremities was slightly increased. On 04 April 2006, the subject was doing poorly. Pain and swelling in his hands was increased with more stiffness. He seemed to have more paresthesia with burning and shooting pain in his upper and lower extremities. Raynaud's phenomenon was a little active, but not severe, he was having difficulty amulating. On 03 April 2007, the subject complained of pain in his joints, especially the hands and feet. Swelling was mostly in the hands. Reynaud's phenomenon was severe. Parestheis in the upper and lower extremities as well as weakness was not really changed. He had prolonged morning stiffness and fatigue. Dryness of the mouth and eyes and abnormal Liver function tests were incidentally noted. The subject was seen on 02 May 2007 for a follow-up of his rhematoid arthritis . It was reported that the  subject had complaints of pain, stiffness and swelling in his joints. Reportedly, these symptoms have not gotton worse. He was receiving prednisone, Porcardia, Pevacid, Liminopril, baby aspirin, Daypre and leucovorin. Impression following exam indicated and denyelinating ployneuropathy. On 01 August 2007, the subject returned for follow-up of his rhematoid arthritis. He was taking prednisone with Daypro. His pain was not so bad. He had some residual swelling. Morning stiffness was better as well as his paresthesia and Raynaud'sphenomenon. Demyelinating ployneurophathy was stable. He failed IVIG. On 06 November 2007, the subject was doing poorly with significantly increased pain and stiffness. He continued on Prednosone and Daypro. He reported some fatigue with parethesia in both legs. A new finding of rash was noted. It was questioned in the subject might have pioriatic arthritis. No new events were documented at this time. Much later, on 25 June 2008, the subject was evaluated for rhematoid arthritis. He reported periods of pain in his right knee and a little over the elbow. There was no major swelling. He still had symptoms of Raynaud's penomenon, however, it was improved on Porcardia. Paresthesia was about the same. He failed IVIG.