Age: 52.0
Sex: M
Vaccine: ANTH
Symptoms: General physical health deterioration, Headache, Hypoaesthesia, Injection site pain, Injection site warmth
Clinical narrative: Information was received on 14FEB2013 in the form of a medical inquiry; additional information was requested by Sponsor. On 18FEB2013, an independent medical evaluation report related to a claim for disability was received, at that time the case was determined to meet expedited reporting requirements. A 52 year old male experienced brachial plexitis, pain in extremities, depression, anxiety, myalgia, tremors, weakness and multiple adverse events which he considered disabling. Vaccine history: BIOTHRAX Dose 1 - 18DEC2006 (lot FAV114). BIOTHRAX Dose 2 - 22JAN2007 (lot unknown). Botulinum Dose 1 - 20FEB2007. Botulinum Dose 2 - 06MAR2007. BIOTHRAX Dose 3 - 11APR2007, (lot FAV114). Botulinum Dose 3 - 22MAY2007. Medical History included: pain disorder - associated with both psychological factors and general medical condition, cognitive disorder, depression, chronic fatigue, anxiety, psychosomatic complaints, lethargy, difficulty with memory and concentration, irritable bowel syndrome, malaise, headache, morbid preoccupation with cognitive dysfunction, hypothyroidism, thyroiditis, vitiligo, hypertension, hyperlipidemia, venous insufficiency, history of migraines (questionable), alcohol abuse, smokeless tobacco abuse. Medical History also included a report of pain and skin lesion following BIOTHRAX dose 1 (VAERS Reference # 280008). On approximately 21APR2007, 10 days after BIOTHRAX dose 3, he developed pain in his right arm, skin lesions on his left and right thigh and ecchymotic areas on abdomen (VAERS Reference #306455). On 09MAY2007, the patient was seen for an Infectious disease consult. It was felt that he had a a mild reaction to anthrax vaccine and he was advised to take acetaminophen. The symptoms resolved. On 22MAY2007 he developed similar symptoms following vaccination with botulinum dose 3. The skin lesions eventually resolved, however numbness & tingling in upper extremities with tremor and weakness in both extremities persisted. On 18JUN2007, at an Occupational Medicine clinic visit, he was authorized to return to work without restrictions, and prescribed PERCOCET for the continued soreness of the arms. On 18JUN2007 during a follow up visit with the occupational medicine physician, he had complaints of persisting pain and warmth over right upper extremity down to hand with shoulder pain since the botulitum injection. Range of motion of shoulder and elbow were normal. He was continued on oxycodone therapy. On 31JUL2007, he was seen by the occupational medicine physician for skin lesions on left brachial area; he was noted to have a 1 cm lesion with a few hyperpigmented areas in the middle with bruising. He reported continued numbness and pain in fingers of right hand. He complained of continued headaches. The patient was again authorized to return to work without restrictions. On 03AUG2007, he was seen in the emergency room with complaints of right arm pain and numbness. A CT scan found no abnormalities. He was diagnosed with peripheral neuropathy and recommended to take acetaminophen or ibuprofen upon discharge. On 09AUG2007, the patient was seen for a neurological evaluation. A nerve conduction study and needle electromyography were performed. The clinical impression was: post vaccinal brachial plexitis thought to have reactivated, but was in the process of resolving. Further evaluation was contingent upon an MRI. On 16AUG2007 an MRI was performed and results were considered to be of questionable significance in light of the history given. On 17MAR2008, at a follow up with the Occupational medicine clinic, the patient complained of extreme fatigue, weakness, paresthesias, and increased pain and discomfort of the right upper extremity with numbness. On 26MAR2008, at a follow up neurology visit he was diagnosed with recurrent brachial plexitis. On 03APR2008, the patient was seen by Occupational medicine physician; an anti-nuclear antibody test was positive and he was recommended to see a rheumatologist. On 10APR02008, he was seen for a second Rheumatology consult where additional testing was performed; the results were not provided. On 17APR2008, at a follow visit with Occupational Medicine physician, he disclosed that he was receiving treatment from a psychiatrist due to stress, anxiety, and depression due to his "condition." He reported extreme fatigue and numbness in bilateral upper extremities. He was again observed to have normal range of motion and strength, The patient, however, was ordered to remain off work at that time. On 25APR2008, at an Occupational Medicine follow up visit his condition was noted to be the same; he was on therapy with NEURONTIN and ibuprofen. He was authorized to remain off work. On 05MAY2008, an MRI of the brain without contrast showed no significant pathology. On 08MAY2008, an Occupational Medicine visit authorized the patient to remain off work due to his symptomology with follow up in 3 weeks. On 21MAY2008, at a follow up visit, the symptomology continued with the additional of sharp pain in the quadriceps and calves. Additionally, it was noted that he had started therapy with KLONOPIN and RITALIN. On 21MAY2008 the Occupational Medicine physician signed a form letter indicating that the patient was unable to work due to post-immunization brachial plexitis. On 26MAY2008 the treating psychiatrist signed a form letter which reported the patient was unable to work due to major depression. On 04JUN2008 the treating Neurologist submitted a form letter which reported the patient was unable to work due to post immunization brachial plexitis. From 27JUN2008 through 17OCT2008 he continued to be seen by Occupational Medicine where his symptomology reportedly continued. During that time, he was started on LAMICTAL for depression by his psychiatrist. He was noted during the visit to have some arm tremors at times. In AUG2009, he underwent extensive testing by a consulting medical center. The consulting facility concluded that the complaints of tremor were related to a functional tremor disorder, additionally it was felt that his underlying depression and insomnia may be contributing to some of his symptoms, especially fatigue and memory complaints. In JUL2010, an independent medical evaluation was performed for workman's compensation. The patient described his primary psychological problems to be: short term memory deficit, difficulty focusing on tasks, profound fatigue, anxiety and "low mood". It was noted that he experienced suicidal ideation on a daily basis, and he had recently tried to commit suicide by overdose of medications. Based on the interview and testing it was felt by the review board that the most likely diagnoses were pain disorder and cognitive disorder, both present prior to 04MAY2007. The record review revealed that the patient was experiencing depression, malaise, fatigue, lethargy, memory loss, decreasing health and mental function, irritable bowel syndrome, and decreased thinking ability prior to vaccinations at work. The conclusion was that the patient experienced a probably post vaccination reaction which had since resolved. The chronic bilateral upper extremity symptoms, chronic fatigue, functional tremor, pain disorder, and cognitive disorder were all thought to be not related to an occupational hazard. The review board denied the patient's disability claim, and it was felt that the patient could return to work. No further information was provided. Medical records available upon request. Concomitant medications included: indapamide -venous insufficiency, lisinopril -hypertension, SYNTHROID - hypothyroid, WELLBUTRIN - depression, and ZOLOFT - depression. Additional treatment information included: LAMICTAL and TOPAMAX - discontinued due to oral and anal pain; lithium - discontinued due to serotonin syndrome, AMBIEN, CYMBALTA, ZOLOFT, PROVIGIL, melatonin, and acyclovir.