Sex: M
Vaccine: LYME, TTOX
Symptoms: Borrelia burgdorferi serology negative, Cardiac disorder, Chest X-ray abnormal, Computerised tomogram normal, Dysuria
Clinical narrative: This case was reported by a law office and described the occurrence of shoulder pain in a male subject of unspecified age who was vaccinated with LYMERIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. The subject's medical history included sinus problems. Previous vaccination included LYMERIX (GlaxoSmithKline) given on 12 April 1999, 0.5 ml in the left deltoid and 12 May 1999, 0.5 ml in the right deltoid. Concurrent medications included NEXIUM, PLAVIX, Atenolol, CELEBREX, LEXAPRO, UROXATRAL, AMBIEN, Morphine, Calcium, SPIRIVA, Magnesium, Multivitamin, CRESTOR, Vitamin B Complex, FOSAMAX, Folic acid, Saw palmetto, Fish oil, FLAX seed, COLACE, Potassium, Aspirin. On 23 June 2000 the subject received 3rd dose of LYMERIX (unknown) at 0.5 ml in the right deltoid. In August 2000, after vaccination with LYMERIX, the subject experienced shoulder pain and shoulder swelling which resolved. On an unspecified date in 2000, the subject developed ankle pain, ankle swelling, autoimmune disease and knee pain. The events resolved with the exception of knee pain. Then in 2001, the subject experienced wrist pain, hand pain, swelling of wrists and hand swelling which eventually resolved. The subject was treated with REMICADE, cortisone, prednisone, ORENCIA and DEMEROL for his various conditions. The subject additionally reported that he has undergone prostate surgeries and continues to have urinary difficulty, has heart disease and experienced ganglioneuroma post LYMERIX vaccine, but feels these events are not related to vaccination. Follow-up information was received on 27 January 2009 in the form of medical records. It was indicated that the subject also received a tetanus vaccine on the date of the 3rd administration of LYMERIX vaccine (23 June 2000). The subject has a history of an unspecified ulcer and was reportedly an alcoholic. According to medical records, the subject suffered from degenerative disc disease and rheumatoid arthritis with complaints of joint pain and low back pain dating back to April 2002. Medications mentioned included Atenolol, aspirin, Methotrexate, PRILOSEC, FOSAMAX, Prednisone, Diclofenac, Sulfonic Acid and Citrucel. An examination dated 29 August 2002 indicated that the subject was suffering from left wrist pain. Rheumatoid arthritis was suspected. The subject was evaluated for lumbosacral pain on 11 November 2002 and was found to have degenerative disc disease of the lumbar spine, lumbar spinal stenosis and rheumatoid arthritis. An evaluation dated 15 January 2003 indicated that the subject suffered from rheumatoid arthritis and was taking REMICADE. On 24 January 2003 the subject was seen for evaluation of low back pain which he reportedly has had for approximately 20 years. An MRI on an unspecified date showed diminished disc height at L3-4 with what appeared to be a large Schmorl's node invaginating the superior inplate of L4. All of the disc of the lumbar spine were dark on the T2 sequence. An exam dated 16 May 2003 revealed rheumatoid arthritis, complaints of poor balance with an essentially normal neurologic exam and possible posterior tibialis rupture on the right. The subject was hospitalized in July 2003 following a myocardial infarction. This was considered to be an incidental finding upon review of medical records. No relationship to LYMERIX vaccine was indicated. On 06 November 2003, the subject was evaluated for right ankle pain. An MRI showed evidence of a partial tear of the flexor hallucis longus and mild teninopathy of the PT tendon. There was also an effusion in the posterior subtalar joint. An exam on 15 December 2003 also indicated rheumatoid arthritis. The subject was said to have improved and was on prednisone and methotrexate. Rheumatoid arthritis symptoms continued into 2004.