Age: 40.0
Sex: M
Vaccine: LYME
Symptoms: Laboratory test abnormal, Neuropathy peripheral, Pain, Pollakiuria, Red blood cell sedimentation rate increased
Clinical narrative: This report described the occurrence of cognitive deficits in a 39 year old male pt who received Lyme disease vaccine recombinant OspA (Lymerix) for prophylaxis.  This report was received as part of litigation proceedings, and was subsequently medically confirmed.  The pt received injections of Lymerix on 03/17/1999, an unspecified date in April 1999, and 04/10/2000 "according to the client."  On 09/03/03, the pt's attorney alleged that the pt "suffered hip achiness, fatigue, weakness, cognitive deficits, morning stiffness, numbness, mood and speech problems which began in September 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 approximately five years.  At the time the pt received the initial Lymerix vaccination, he was also receiving Biaxin and guaiphenesin.  Pharmacy records indicated that Lymerix vaccine was dispensed on 03/10/99.  A financial history provided by the pt's physician indicated that the pt received Lyme disease vaccine on 03/20/00.  On 09/13/99, and again on 12/20/99, 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 03/20/00 and 04/10/00, the pt was examined for bilateral hip pain and possible trochanteric bursitis.  X-rays 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 triamsinolone injection.  Treatment included Celebrex, and the pt was enrolled in physical therapy from 04/20/00 through 09/14/00. On 07/10/00 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 07/14/00, the pt presented with complaints of polyarthralgia.  On 07/26/00, 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 October 1999.  Lyme titer and rheumatoid factor tests were negative.  X-rays of hips were negative, and liver function tests 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 04/10/00 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, and in December 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 11/06/00, he complained of unimproved hip pain unhelped by Vioxx and worse following exertion, forgetfulness, inability to trace sentences, tiredness in the afternoons, exhaustion, unorganized thoughts, clumsiness, anger and rage (well-controlled), nocturnal waking, and urinary frequency.  He was diagnosed with polyarthralgias, with concern of fibromyalgia following Lyme disease which was treated.  On 12/06/00, 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 day in the previous six months."  Per this information, this case was considered disabling.  On 02/07/01, he was examined for polyarthralgia and sleeplessness.  He stated at that time he was "finally" feeling better.  Ativan was added to Sonata for treatment of sleeplessness.  On 02/27/01, he presented with complaints of blurred near and distance vision.  By 03/14/01, 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 06/20/01, he continued to experienced significant fatigue, memory problems, "severe" headaches, ringing in the left ear, urinary frequency, poor balance, falling and hip pain.  Tingling in hands, eye twitches, and diarrhea were improved.  On 10/24/01, 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, that 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 02/27/02, he presented with cognitive dysfunction approximately one to one and a half weeks per month associated with word-finding difficulty, fogginess, and getting lost while driving.  He also complained of headaches, blurred vision despite negative ophthalmological evaluation, neck and shoulder arthralgias, tripping, severe left hip pain, insomnia, fatigue, and hand paresthesias.  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, improved blurred vision, dizziness, eye twitching, memory problems and ringing in ears.  He reported continued sensitivity to bright lights 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 03/13/02, the pt was evaluated for post-Lyme polyarthralgia.  On 04/03/02, x-rays of the pelvis and bilateral hips revealed mild osteoarthritis, slightly greater in the right than in the left.  Medical records dated 06/05/02 indicated that the pt experienced a vaccine associated reactivation of Lyme disease.  Symptoms included joint pains, 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 11/06/02, the pt reported no increase in symptoms, although he continued to experience episodes of increased hip pain exacerbated by exercise, fatigue, diarrhea and word-finding problems.  He complained of ongoing finger numbness that caused him to drive off the road.  Sleep problems were improved and eye twitching had resolved.  He was diagnosed with residual symptoms of Lyme disease.  Therapy included lorazepam, Zoloft, Ambien, and tetracycline.  On 04/02/03, the pt's Lyme disease was evaluated as improved, although he continued to experience a "few symptoms" including neck clicks, loss of sensation in his hands from his knuckles distally, and mild pain radiating to his shoulders.  Diarrhea, ear ringing and eye twitching resolved.  Fatigue and headaches 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 pt's medical records.  Therefore, it is not listed as an adverse event. On 15 September 2004, the patient's attorney alleged that the patient experienced "severe hip pain, fatigue, gait disturbances, peripheral neuropathy, cognitive deficits, and moring stiffness." Time to onset, treatment and outcomes were not reported.