Age: 50.0
Sex: F
Vaccine: LYME
Symptoms: Hypoaesthesia, Inappropriate schedule of drug administration, Myalgia, Neuropathy peripheral, Paraesthesia
Clinical narrative: This report described the occurrence of fatigue in a female patient who received LYMERIX vaccine. This report was received as part of litigation proceedings, and has not been verified by a physician or other health care professional. The patient received injections of LYMERIX on 23 June 1999, 22 July 1999, and 27 January 2000 "according to the client." This represents a schedule of 0,1, and 7 months rather than the recommended schedule of 0,1, and 12 months.  On 03 September 2003, the patient's attorney alleged that the patient "suffered fatigue, urinary tract discomfort, dizziness, headaches, fevers, joint aches and pain beginning in the fall of 1999 according to the client." Treatment and outcomes of the alleged events were not reported. On 15 September 2004, the patient's attorney alleged that the pt (now 55 years old) experienced "numbness, tingling, dizziness, headaches, fatigue, peripheral neuropathy and abnormal SPECT (single photon emission computerized tomography scan with decreased perfusion of both basal ganglial regions. "Time to onset, treatment and outcome were not reported. Follow up informaiton was received on 14 November 2008 via an interview between Lawyers and the subject. yhe subject was vaccinated with LYMERIX in June 1999, July 1999, and January 2000. In June 1999, she developed vertigo, dizziness, nausea, body tingling, achiness, headaches, loss of balance, fatigue, bladder problems, dry eyes, and stomach symptoms. Treatment included MAALOX, PRILOSEC, amitriptyline, ADVIL, meclizine, NEURONTIN, LEXAPRO, CYMBALTA, LYRICA, and nortriptyline. The events were unresolved at the time of this report. Follow up information was received on 19 November 2008 via medical records. The subject received LYMERIX in June 1999, July 1999, and January 2000. In July 1999, shortly after her first LYMERIX vaccination she developed flu like symptoms, aching pains, inbalance, and urinary urgency sunsequently diagnosed as interstitial cystitis. She subsequently developed pressure or swelling with aching, stinging, pinching, and muscle twitching of the face, tingling and pins-and needles sensations in her hands, chest and stomach, and "sensations of water running down the legs". In May 2000 she was diagnosed with probable Lyme disease and received treatment of antibiotics, including six to seven weeks of intravenous antibiotics. Treatment included amitriptyline, nortriptyline, ZITHROMAX and AMBIEN; she was unable to tolerate NEURONTIN. In December 2001, she developed atypical facial and dental pain following a flu-like illness, and was treated symtomatically followed by head pressure and palpitations. A second physician noted that the subject developed "disabling" symptoms in December 2001, including malaise, fatigue, marked facial and throat pain, nocturia with severe pelvic pressure urgency and frequent urination, bilateral hand and foot paresthesias, ill feeling, body fatigue, and poor sleep. The evaluating rheumatologist indicated that the subject's "clinical picture fits more with something in the realm of a chronic pain and fatigue syndrome", and she was encouraged to suspend Lyme disease treatment. She underwent treatment for trigeminal neuralgia including doxycycline, BIAXIN and ZITHROMAX. On 22 March 2002, possible thyroid disorder and/or cortisol deficiency were ruled out as a cause for fatigue. Neuropathy persisted in December 2002. On 18 February 2003, progress notes indicated an impression of Lyme disease. She was evaluated by a neurologist on 04 May 2004, and it was reported that she "may be suffering a small fiber neuropathy or ganglioneuritis. It could be related to Lyme disease or vaccination". Neurology follow up exam on 06 November 1006 showed unchanged neuropathy since 2004. It was recommended that she gradually increase amitriptyline to better control pain. Follow up information was received on 01 April 2003 via medical records. The subject had a history of chronic fatigue syndrome as early as 1996. Neurological consultation on 27 September 2000 indicated that the subject had a history of neck problems since at least 1997 and multilevel lumbar spine degenerative changes fromas early as 1996. Impression was of degenerative disc disease and radiculopathy with an "entirely normal" neurological examination. the subject reported debilitating symptoms since approximately 2001. In May 2003, repeat neurologic examination was again "entirely normal". The subject was followed between 16 December 2004 and 11 July 2005 for Lyme disease with symptoms including "stranged"/"crushing headaches, gait disturbance, equilibrium changes, urinary frequency/ urgency/ distress, ear pain, teeth pain, difficulty swallowing, multifactorial sensory neuropathy, "vague chest sensations suggesting a heart attack", and joint pain. The subject reportedly had a history of long term fever and multiple symptoms "about seventeen years ago" and it was noted that this was "never treated and that is probably causing the residual symptoms she is having now". Magnetic resonance imaging of the brain reportedly showed some "mild to moderate shrinkage which is unusual for a lady of this age", and antinuclear antibody testing was positive. Diagnoses included possible chronic fatigue syndrome, Lyme disease, and interstitial cystitis. Medications included AMBIEN, ELAVIL and amitriptyline. On 11 July 2005, progress notes indicated long-standing Lyme disease with sensory neuropathy, with a current flare of multiple symptoms including eyeball pain, ear pain, throat pain with swallowing, tooth pain, and sinus pain. treatment included ELAVIL and TOPAMAX. On 24 May 2007, physician's assessment was of Lyme disease with "tertiary stage with involvement of many of her sensory nerves but none of her motor nerves". At that time, she was receiving amitriptyline. On 11 September 2007, the subject presented with a chief complaint of possible Lyme disease/sickness, treated in the past with doxycycline and clarithromycin, with "marginal" improvement over the preceding four to five years. Symptoms included numbness/pain in face and teeth, vertigo, and paresthesis. It was noted that current serology for Lyme was negative and that "this picture is not strongly supportive of Lyme disease". The subject was evaluated on 02 September 2008 for "severe neuropathies all over her face, teeth, ears, throat, stomach, hands, and legs" which the subject described as "incapacitating and associated with fever". She also reported chronic fatigue, dryness of mucosal surfaces, palpitations, constipation, gastroesophageal reflux, color changes of her hands (did not meet characteristics of Raynaud's), headaches, dizziness, and poor sleep. The physician noted a "striking positive test was a positive SS-A with negative antinuclear antibody test. This would allow one to make the diagnosis of mild lupus or Sjogren's". The physician's further stated that the subject "clearly has sicca symptoms, but they may be due to amitriptyline". The subject expressed reluctance to take LYRICA. On 02 October 2008 it was noted that her symptoms were "quite profund relative to a lack of physical findings" and that she "may very well have a profund autoimmune disorder". She was evaluated as recently as 22 October 2008 for ongoing symptoms with progressive worsening of headache, facial numbness, "uterine teeth", numbness, facial tingling and soreness, classic migraine with aura. Follow-up information was received on 24 April 2009 via medical records. A note dated 23 August 2003 inlcuded that the subject had been seen on 09 january 2008 because of constant desire to void, urgency, frequency with a long history of urinary tract infection. Work-up revealed white blood cells in her urine, but a culture was negative. An IVP was within normal limits. Cystoscopy revealed a urethral stricture, good capacity and a trigenitis. testing dates were not specified. She was treated with DIPTROPAN. On 06 November 2003. the subject was having palpitations. Cardiac work-up was suggested. The subject was seen on 29 June 2007 for intermittent pelvic pain with a known fundal fibroid. An evaluation revealed a small uterine fibroid via trans-vaginal ultrasound. Follow-up information was received via a statement of injuries on 12 June 2009. The statement indicated that the subject suffers and has suffered from flu-like symptoms, fatigue, headaches, dizziness, urinary tract problems, numbness in extremities, ear pain, facial pain, eye pain, tightness in tongue, throat and chest, tingling in her extremities and decreased activities of daily life. The client also suffered from rheumatological symptoms, neurological symptoms and cognitive impairment of an autoimmune, immune-mediated or other mechanism, all caused by vaccination with LYMERIX.