Age: 66.0
Sex: M
Vaccine: LYME
Symptoms: Sinus bradycardia
Clinical narrative: Report A0359752A describes memory loss and pain in the neck and shoulder joints in a 66 year old male vaccinee who received Lyme disease vaccine recombinant in a lyme disease clinical trial. this report was received as part of litigation proceedings and has not been verified by a physician or other healthcare professional. Medical history included hyperlipidemia, TMJ (temperomandibular joint) syndrome, "trigger finger" on left hand (August 1996), injury to right shoulder while skiing (1970), and episodic cardiac palpitations due to caffeine. The vaccinee is reportedly allergic to meperidine (Demerol). Concurrent medications included atorvastatin calcium (Lipitor) and aspirin. The vaccinee participated in protocal 008 and received three doses of placebo. The vaccinee continued into protocol 013 and received right deltoid intramuscular injections of Lymerix vaccine on 08 Apr 1997, 13 May 1997, and 23 May 1998. In a Statement of Injuries, his attorney alleged that the vaccinee suffers from pain in his joints, specifically in his shoulders. He also suffers from memory loss. On 4 Feb 1998, the vaccinee was seen by a cardiologist. On 12 Feb 1998, the vaccinee underwent Holter monitoring for premature atrial contractions (PAC's). The workup revealed a benign cardiac rhythmn of sinus brachycardia with heart rates from 38 to 80/minute (average 55), frequent (2.3%) APC's, isolated, pairs of short (maximum length 5 beats) self-limiting runs (maximum rate 107/minute). An echcardiogram revealed mild mitral regurgitation with left atrium upper limit of normal. On 18 Feb 1998, an echocardiogram revelated mitral annular calcification with moderate mitral regurgitation, and normal left ventricular function. On 24 Feb 1998, the vaccinee was again seen by a cardiologist. The cardiologist did not believe that he has mitral regurgitation but would like to repeat an ascultatory exam and echocardiogram in one year. On 16 May 1998, approximately 10 months after the second dose of Lymerix vaccine, the vaccinee was evaluated for a painful right neck by an orthopedist. His symptoms had reportedly increased over the prior three months. On physical examination, the vaccinee had significant loss of motion in all planes of the cervical spine. He had mild orepitus of the right shoulder, but no evidence for rotator cuff tear or proximal biceps tear. Motor strength was within normal limits. Sensory examination was normal. Reflexes were symmetric and there was no winging of the scapulae. X-rays from 17 Mar 1998 showed degenerative disc disease at 05-06 and 06-07. The orthopedist reported that the vaccinee had loss of motion and discomfort secondary to cervical disc disease. On 19 Jan 1999, the vaccinee saw a neurologist. The vaccinee reportedly fell backwards on the ice the day prior and broke his fall with his hands, but struck the back of his head on the ground. He reportedly developed a low grade headache which continued to 19 Jan 1999 with accompanying neck pain and stiffness. He also had a bump on the head from the impact. Per the vaccinee, there was no loss of consciousness, and he denied any and/or all other common neurologic signs, symptoms, or complaints, except for the possibility of a minor droop of the left eyelid. On physical examination, the vaccinee was found to have significant spasm in the cervical paraspinal muscles particularly on the right side and neck range of motion was limited by pain and spasm. Discs were normal and no cervical bruits were present. His heart rate was regular without rubs, murmurs, or gallops. On neurologic examination, there were no cognitive or linguistic deficits. Examination of cranial nerves II through XII were within normal limits. There was no muscle weakness, atrophy, or drift. Rapid and fine alternating movements were well performed in all four extremities. Sensory testing to pain, touch, vibration, and temperature was normal. There were no cerebellar or extrapyramidal findings, reflexes were 1+ and symmetrical, there were no Babinki's, Hoffman's, or palmomentals. The impression was post traumatic muscle contraction headaches and cervical flexion-extension injury. The vaccinee was sent for rehab for shoulder spasms, given neck stretches to perform, and prescribed acetaminophen for pain control. An echocardiogram on 24 Feb 1999 revealed mitral valve prolapse more apparent compared to previous study but still mild, normal left ventricular systolic function and mild tricuspid regurgitation. An exercise stress test on 02 Feb 2000 revealed frequent APC's (isolated only) noted with decrease in frequency during stress. The impression: negative maximal (93%) regular Bruce exercise tolerance test at excellent external workload. No chest pain. Lab testing on 14 Jul 2000 included Westergren erythrocyte sedimentation rate 18 mm/hr (reference range 1-14) and rheumatoid factor less than 20 IU/mL. Lyme disease Western blot on 24 Aug 2000 was equivocal for IgG and IgM bands. On 11 Dec 2000, the vaccinee reported that following the third dose of Lyme vaccine, he developed stiffness in his neck and shoulder pain. Several months later, he reportedly went for physical therapy which made no impact. A cervical spine study on 12 Dec 2000 demonstrated foraminal enrroachment on the left side of C5-6 and were increased compared to the prior study (17 Mar 1998) consistent with increasing severe degenerative changes of the lower4 cervical spine. Per doctor's notes, company ran tests which showed HD4 gene which can be triggered by Lyme vaccine which in turn can cause arthritic neck pain and arthritis elsewhere. Treatment included doxycycline for about one month with questionable improvement in symptoms. On 29 Jan 2001, the vaccinee was seen by neurologists for reported neck stiffness. Per the vaccinee, he had no pain but still had limited mobility with neck. Neck muscles continued to be tight. C-spine film was reviewed with the vaccinee. The vaccinee indicated in a review of symptoms that he suffered from arthritis and memory loss. On 02 Feb 2001, the vaccinee was again seen by neurologists for neck and shoulder pain. TENS were applied to the neck and shoulders, and the vaccinee was shown placement and programs for use. Lyme testing on 30 Nov 2001 included ELISA Titer IgG less than 80 (normal), Western blot IgG and IgM negative and revealed no evidence of seroreactivity beyond that expected from the Lyme vaccine. A letter sent to an orthopedist on 08 Feb 2002 requested a pre-operative consultation for the vaccinee for diagnostic surgical arthoscopy left shoulder, and anterior acromioplasty with distal clavicle extension. The surgery was planned for 25 Feb 2002 for a diagnosis of grade II impingement, acromioclavicular jopint arthritis of left shoulder. On 20 Feb 2002, the vaccinee was seen for evaluation of chest pain. Electrocardiograph showed sinus bradycardia with right bundle branch block and isolated APC's. There were no significant ECG changes, and a few premature atrial contractions during exercise. There was a negative ECG response to maximal treadmill exercise. There was a mildly abnormal perfusion SPECT imaging after treadmill exercise showing very subtle basal inferior ischemia. On 19 Mar 2002, the vaccinee was seen by a cardiologist for a newly developed right bundle branch block. A MRI was done. The vaccinee did "superb exercise with 12 minutes and a normal EKG. His acintigraphie findings are very mild and the cardiologist believes are essentially normal. Per the cardiologist "note should be made that with the right bundle branch block, [the vaccinee] may have progressed electrical dysfunction and eventually be a candidate for a pacemaker....". On 26 Mar 2002, the subject was assessed by his internist for pre-operative clearance for proposed surgical arthroscopy of the left shoulder. The adverse events memory loss and joint pain do not meet ICH serious criteria, but are being submitted as an expedited report by special request per the June 28, 2000 letter.