Age: 56.0
Sex: M
Vaccine: LYME
Symptoms: Restlessness, Spinal osteoarthritis, Synovial fluid analysis abnormal, Tonic clonic movements, Unresponsive to stimuli
Clinical narrative: This case was reported by a lawyer and described the occurrence of arthralgia in a male subject of unspecified age who was vaccinated with LYMErix for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of LYMErix (unknown). An unspecified time after vaccination with LYMErix, the subject experienced arthralgia, body aches and pains, swollen joints, and rheumatologic, neurologic and or cognitive impairment of an autoimmune, immune-mediated or other mechanism. At the time of reporting the outcome of the events was unspecified. The information in this case was received via a Statement of Injuries. Follow up information was received on 27 December 2007 via medical records. The subject's history included non-small cell lung carcinoma, chronically elevated liver function tests, chronic obstructive pulmonary disease, osteoarthritic spurring of the lumbar vertebrae, and back pain. The subject received his first, second, and third doses of LYMErix (all administered intramuscularly in the left deltoid , 0.5 cc) on 16 June 1999, 05 July 1999, and 30 August 2000. Approximately 10 months after the third LYMErix injection on 08 July 2001, the subject presented to the emergency room due to pain in elbow. Right elbow radiology results were normal. On 23 July 2001, he was seen for follow up of right elbow swelling and was diagnosed with bursitis. Treatment included Celebrex. In early August 2002, the subject developed pain in the upper back over the right shoulder area. A subsequent x-ray revealed a mass in the apex of the left lung, and a bone scan was recommended in light of shoulder pain. He was diagnosed with non small cell lung cancer. The subject was hospitalized on 08 July 2004 with a chief complaint of generalized seizure (according to the subject's wife) after experiencing tonic clonic activity and urinary incontinence. He had reportedly experienced irritability and personality changes in the preceding few months. In the emergency department, he exhibited agitation and delirium. He was "striking out" and required four-point restraint. Treatment included Dilantin and Valium. His oncologist was consulted due to end-stage non small cell lung cancer, and reported that the subject had undergone radiation therapy and chemotherapy following his diagnosis of small cell lung cancer, and his disease was reportedly "at a standstill". At the time of admission medications included Neurontin for arm neuropathy in addition to potassium chloride, Endocet, Ambien, oxandrine, Bextra, Ritalin, Prilosec, and "a variety of herbs and supplements". His pain medications were reported for treatment of neck pain. The indications for these medications, with the exception of Neuronton and pain medications, were not provided. A computed tomography scan was of poor quality but was suggestive of cerebral metastasis. It was noted that "metastases may certainly explain the seizure". Impression was of 1) non small cell carcinoma of lung, metastatic to brain with new onset seizures status post radiation and chemotherapy and 2) chronic neck and shoulder pain from metastatic lung cancer. He was discharged on 11 July 2004 with a final diagnosis of grand mal seizure and secondary diagnoses of multiple cerebral metastases, one and a half year history of non small cell lung cancer, and brachial plexopathy status post chemotherapy and radiation therapy. He returned to the emergency department on 27 September 2004 with increasing weakness and lethargy and bilateral plexopathies secondary to metastatic disease. He reported "several seizures" over the past several weeks, and increased dyspnea on exertion. At that time he was diagnosed with pneumonia "most likely post-obstructive from tumor". He was admitted with diagnoses including seizure disorder "secondary to his metastatic lung cancer", acute renal failure secondary to dehydration, coagulopathy with strong suspicion of liver metastases, anemia, and cancer pain. Renal function improved, but pulmonary status did not. His white blood cell count increased despite antibiotic therapy, and he experienced decreased responsiveness and restlessness. He died on 30 September 2004. Due to the original claim of arthralgia, body aches and pains, swollen joints, and rheumatologic, neurologic and or cognitive impairment associated with LYMErix vaccinations, the events of seizures and associated symptoms, arm neuropathy, personality change, irritability, delirium, and agitation were reported as adverse events. The events of seizures and urinary incontinence were assessed to be medically significant. However, due to the subject's diagnosis of metastatic non small cell lung cancer with brain and possibly liver metastases and the lack of identification of an association with LYMErix vaccination, the remaining events and the subject's hospitalization and death in September 2004 were considered to be incidental findings.