Age: 39.0
Sex: M
Vaccine: LYME
Symptoms: Clumsiness, Cognitive disorder, Confusional state, Conjunctivitis, Depression
Clinical narrative: This report described the occurrence of cognitive deficits in a 39 year old male pt who received Lyme disease vaccine recombinant (Lymerix) for prophylaxis. This report was received as part of litigation proceedings, and was subsequently medically confirmed. The pt received injections of Lymerix on 3/17/1999, an unspecified date in April 1999, and 4/10/00 according to the client. On 9/3/03, the pts attorney alleged that the pt suffered hip achiness, fatigue, weakness, cognitive deficits, morning stiffness, numbness, mood and speech problems which began in Sept of 1999 according to the client. The following information was reported via medical records. Medical history included lumbar sprain, myopia, Helicobacter pylori ulcers, conjunctivitis, high frequency hearing loss, panic attacks, and rotator cuff surgery. He lived in a heavily wooded area and reported that he had pulled numerous ticks off himself, but knew of no specific tick bite that was engorged or resulted in a rash, however, he reported generalized lethargy over approx five years. At the time the pt received the initial Lymerix vaccination, he was also receiving Clarithromycin (Biaxin) and gualphenesin. Pharmacy records indicated that Lymerix vaccine was dispensed on 3/10/1999. A financial history provided by the pts physician indicated that the pt received a Lyme disease vaccine on 3/20/00. On 9/13/1999, and again on 12/20/1999, the pt presented with complaints of bilateral hip pain and occasional first and second finger numbness. He responded to a pulse dose of steroids. On 3/20/00 and 4/10/00, the pt was examined for bilateral hip pain and possible trochanteric bursitis. X ray were reviewed, and calcitic deposits along with mild osteoarthritis were noted. He complained of pain that affected walking, stair climbing, and squatting. He was noted to have done exceedingly well with Triamcinolone injections. Treatment included Celebrex, and the pt was enrolled in physical therapy from 4/20/00 through 9/14/00. On 7/10/00 the pt reported that he was doing much worse, with increased pain in the hips. His activities were significantly limited. secondary to pain, which generated anxiety and depression. On 7/14/00, the pt presented with complaints of polyarthralgia. On 7/26/00, the pt was evaluated for management of possible lyme disease and possible lyme disease vaccine related reaction. The pt reported that he had received his first two Lymerix vaccinations in March 1999 and April 1999, and that over labor day weekend experienced hip pain, restless sleep, and much more severe fatigue requiring frequent naps. The pain was described as entirely weight bearing and was noted after walking two to three miles, He reported hobbling in Oct 1999. Lyme titer and rheumatoid factor tests were negative. X rays of hips were neg, and liver function test were slightly elevated. He received non steroidals without benefit, and reported limited improvement on oral prednisone. He received cortisone injections in the hips with transient improvement and reported marginal benefit on Celebrex. He reported that he received his third Lymerix vaccination on 4/10/00, and that within one week he developed worsening hip pain (left more than right), increased fatigue, and sleep difficulties (primarily waking up). At the time of examination, he experienced headaches, balance issues thought to be related to weakness, occasional chest tightness associated with some anxiety, morning stiffness, unreliable memory, and difficulty losing temper. He was diagnosed with chronic active lyme disease that was accentuated by the Lyme vaccine. Treatment with Plaquenil and Biaxin was initiated, an in Dec 2000 Doxycycline was added. He was later switched to Tetracycline. The pt was assessed to have reached his maximum benefit from physical therapy, and he chose to discontinue treatment. On 11/6/00 he complained of unimproved hip pain unhelped by Vioxx and worse following exertion, forgetfulness, inability to trace sentences, tiredness in the afternoon, exhaustion, unorganized thoughts, anger and rage (well controlled), nocturnal waking, urinary frequency. He was diagnosed with polyarthralgia, with concern of fibromyalgia following lyme disease which was treated. On 12/6/00, symptoms included fatigue, poor memory, pain and sleep problems. He noted that physical therapy had not been helpful. The pt reported that he was able to do three full days of work per week whereas he had not put in more than one full in the previous six months. Per this information, this case was considered to be disabling. On 2/7/01, he was examined for polyarthralgia and sleeplessness. He stated at that time that he was finally feeling better. Ativan was added to Sonata for treatment of sleeplessness. On 2/27/01, he presented with complaints of blurred near and distance vision. By March 2001, he was able to work three full days weekly. Mental focus, memory, and eye twitching were improved, but hand numbness and insomnia remained unchanged. He also complained of occasional headaches, ear ringing, neck pain, morning stiffness, muscle soreness with exercise, balance problems, falling, and episodic diarrhea. He was receiving Vioxx, Lorazepam, and Zoloft. By 6/20/01, he continued to experience significant fatigue, Memory problems, severe headache, ringing in left ear, urinary frequency, poor balance, falling, and hip pain. Tingling in hands, eye twitches, and diarrhea were improved. On 10/24/001, the pt experienced a flare of symptoms especially in his shoulders and neck, and was unable to raise his arms to tie his tie. He reported improvement with Plaquenil and Biaxin, although he reported that on an unspecified date he presented to the ER due to neck and shoulder aches. He complained of diarrhea, the was attributed to Plaquenil and Biaxin. Additional complaints included persistent hip pain and difficulty getting around, tingly and numb hands, urinary frequency, and periodic headaches behind the right eye. Concentration, ability to focus, balance, energy, and speech were improved. The pt reported that he was able to put in a full day at work four out of five days a week. Doxycycline was added to Clarithromycin plus hydroxychloroquine. His symptoms resolved within two weeks. On 2/27/02, he presented with cognitive dysfunction approx one to one and a half weeks per month associated with word finding difficulty, fogginess, and getting lost driving. He also complained of headache, blurred vision despite negative ophthalmological evaluation, neck and shoulder arthralgias, tripping, severe left hip pain, insomnia, fatigue and hand paresthesia.  At an unspecified time, treatment with Neurontin was initiated he reported improvement of diarrhea, eye twitching, and imbalance. He was switched from tetracycline to Clarithromycin, hydroxychloroquine, and Doxycycline, and from Sonata to Ambien. Prior to examination in June 2002, the pt reported improvement in ability to communicate with decreased concentration and word finding difficulties, improve blurred vision, dizziness, eye twitching, memory problems, and ringing in ears. He reported continued sensitivity to bright light and sunlight, pain in joints, numbness and tingling of hands, clumsiness, falling due to hip instability, diarrhea, hair loss, a fifteen pound weight loss, poor sleep, irritability, neck and shoulder pain, urinary frequency, and neck click. He also reported problems ejaculating, which was thought by his physician to be due to Zoloft. The pt stated that he was able to work more than full time, which he considered an improvement over the preceding two years. On 3/13/02, the pt was evaluated for post lyme polyarthralgia. On 4/3/02, X rays of the pelvis and bilateral hips revealed mild osteoarthritis, slightly greater in the right than in the left. Medical records dated 6/5/02 indicated that the pt experienced a vaccine associated reaction of Lyme disease. Symptoms included joint pain, parasthesias, sleep problems, and periodic tiredness. He also complained of heat intolerance and some weight loss. Treatment included Plaquenil, Biaxin, Ambien, Lorazepam, Vioxx, Doxycycline, and tetracycline. At that time, he was assessed as having made good progress. Upon examination on 11/6/2002, the pt reported no increase in symptoms, although he continued to experience episodes of increased hip pain exacerbated by exercise, fatigue, diarrhea, and sensation in his hands from his knuckles distally, and mild pain radiating to his shoulders. Diarrhea, ear ringing, and eye twitching resolved. Fatigue and headache were improved. Zoloft was switched to Bupropion (Wellbutrin) due to sexual dysfunction. treatment with Plaquenil and Biaxin was resumed. Following the reported onset of Lyme disease reactivation, the pt experienced epigastric pain assessed to be classic gastroesophageal reflux disease. This was not reported as an adverse event due to vaccine administration, but was found during the course of review of the pts medical records. Therefore, it is not listed as an adverse event. On 9/15/04, the pts attorney alleged that the pt experienced severe hip pain, fatigue, gait disturbances, peripheral neuropathy, cognitive deficits, and morning stiffness. Time to onset, treatment, and outcomes were not reported. Follow up information was received on 10/30/06 via medical records. The subject reportedly received his second Lymerix vaccine on 4/20/1999. Progress notes dated 12/20/1999 indicated bilateral hip pain and first and second finger numbness that responded to a pulse dose of steroids. In a questionnaire completed by the subject on 4/24/03, he reported continued blurred vision, sensitivity to light, periodic ringing in his ears, sun sensitivity, irritability, and sexual dysfunction. A neurological assessment included development of possible encephalopathy and possible small fiber neuropathy following Lymerix vaccination, with gradual improvement. On follow up, the neurologist indicated that the subjects symptoms were probable due to small fiber neuropathy, probably secondary to the Lymerix vaccination, although celiac disease should also be considered. It was also noted that paresthesia were not sufficiently bothersome at the time to warrant medication. A consult examination was performed on 7/1/03 and the evaluator noted that the subject was diagnosed with Lyme disease approx one year ago, possibly present for five years. The subject had recently undergone Lasik surgery to the eyes. Examination revealed mild malaise, mild night blindness, and peripheral neuropathy. The subject was evaluated in Oct 2003 for bilateral hand numbness which was thought to be residual peripheral neuropathy after Lyme, in addition to post lyme polyarthralgia. On 6/23/05 the subject was evaluated for progression of sensory symptoms, and a skin biopsy significantly reduced epidermal nerve fiber consistent with small fiber neuropathy. A progress note dated 9/24/03 indicated that the subject had been newly diagnosed with celiac disease, and received instruction on a gluten free diet. This was considered to be an incidental finding on review of medical records. In a statement of Injuries, the subjects attorney alleged that the subject suffers and has suffered from arthralgias, fatigue, headaches, tingling, memory problems, influenza like symptoms, numbness, difficulty walking, speech problems, tremors, cognitive difficulty, vision problems, stiffness, severe hip pain, weakness, sleep difficulties, decreased physical activity, rheumatological symptoms, neurological impairment, cognitive impairment and immune system disorder following administration of Lymerix.