Age: 59.0
Sex: F
Vaccine: LYME
Symptoms: Headache, Injection site pain, Malaise, Pain, Upper respiratory tract infection
Clinical narrative: Post 2nd dose of vax, She experienced pain at the injection site, overall body aches, general malaise, and headache. Additionally, she experienced bilateral calf pain and feet pain in May 2000. She stated that a doctor visit was required, and she was treated for an upper respiratory infection with Levoguin.  Received 10/19/2000: "The vaccinee has no allergies, reportedly.  Her medical history includes thymus irradiation at age two months, sinus problems (NOS), hypertension, and Lyme disease in October 1999.  She had a bull's eye rash and was treated with doxycycline for two weeks.  The vaccinee stated that she did not have blood work done in October 1999, to check for Lyme disease, but was told by her physician that "she had it".  Concomitant medications include verapamil, hydrochlorothiaside/losartan potassium (Hysaar), and fluticasone propionate (Flonase).  She had no illness at the time of vaccination.  On 04/18/2000, the vaccinee received her first IM-right deltoid dose of Lymerix Post-vaccination, starting on 04/18/2000, she experienced pain at the injection site.  A few days post-vaccination, she experienced overall body aches, general malaise, and headaches.  On 05/01/2000 she experienced arthralgias of the knees, ankles, and wrists.  This last adverse event was considered mild in intensity, possibly related to Lymerix and ongoing.  On 05/16/2000, she received her second IM-right deltoid dose of Lymerix.  Following dose 2 of Lymerix, she continued to experience her dose 1 adverse events.  Additionally, she experienced bilateral calf pain and feet pain in May 2000.  she stated that a doctor visit was required, and she was treated for an upper respiratory infection with Levoquin 500mg once daily starting on 05/08/2000.  Lymerix was discontinued "at present".  The most recent information, received on 10/16/2000, reports the condition of the vaccinee as ongoing.  This case is considered incapacitating/disabling by the responsible physician and therefore ICM serious. A 15-day follow up report received 01/18/2003 adds: The pt has no allergies, reportedly. Her medical history includes thymus irradiation at age 2 months, sinus problems, hypertension and Lyme disease in October 1999. She had a bull's eye rash and was treated with doxycycline for 2 weeks. The pt stated that she did not have blood work done in October 1999 to check for Lyme disease, but was told by her physician that "she had it". Concimitant medications include verapamil, hydrochlorochizide/lopartan potassium (Hyzzar) and fluticazone propionate (Flonase). She had no illness at the time of vaccination. On 04/10/2000 the pt received her first IM-right deltoid dose of Lymerix. Post-vaccination, starting on 04/18/2000, she experienced pain at the injection site. A few days post-vaccination, she experienced overall body aches, general malaise, and headaches. On 05/01/2000 experienced arthralgias of the knees, ankles and wrists. Her joint complaints were evaluated by a physician. The arthralgias were considered mild in intensity, possibly related to Lymerix and ongoing. On 05/11/2000 she had a positive Lyme test. On 05/16/2000 she received her second IM-right deltoid dose of Lymerix. Following dose 2 of Lymeriz, she continued to experience her dose 1 adverse events. Additionally, she experienced bilateral calf pain and feet pain in May 2000. She stated that a doctor visit was required, and she was treated for an upper respiratory infection with Levoquin 500 once daily starting on 05/08/2000. Lymerix was discontinued "at present". The most recent info received on 01/02/2001 reports the condition of the pt as unknown. This case is considered incapacitating/disabling by the responsible physician and therefore serious. A 15-day follow up report received 4/15/2002 adds: The pt had no known drug allergies. Her medical history included thymus irradiation at age 2 months, sinus problems, hypertension, increased cholesterol, sinus bradycardia, nonspecific St-T wave abnormalities, premature ventricular contractions, premature strial contractions, near syncope, trace mitral and tricuspid regurgitatica with structurally normal valves and Lyme disease in October 1999. ... Following the reported onset of adverse events, the pt experienced left-sided abdominal pain, colonic bleeding, and lesions on her back and left eye. The lesions were excised. The pathologist's diagnosis regarding the back lesion was epidermal inclusion cyst. These events were not reported as adverse events due to vaccine administration, but were found during the course of review of the pt's medical records. Therefore, they are not listed as adverse events.... On 02/11/2002, in a Statement of Injuries, the pt's attorney alleged that "Shortly after receiving her first shot, (she) suffered pain in her arm so severe, she was hardly able to lift it. Since that time, has suffered from joint pain in her knees, as well as daily headaches, sinus trouble and numerous upper respiratory infections. In addition, she has had severe swelling in her left ankle and pain in her left foot." The most recent info, received on 02/25/2002, did not specify the outcomes of the reported events. Info received 2/11/2002 indicated that daily headaches persisted. The outcomes of the other reported events was not provided. The vaccine provider considered the bilateral calf and foot pain, arthralgias, upper respiratory infection and possible Lyme disease to be incapacitating/disabling. Follow up 02/26/2002: "Additional information was received as part of litigation proceedings.  The pain was allegedly "so severe, she was hardly able to lift" her arm." Follow up 03/15/2002: "Since that time, has suffered from joint pain in her knees, as well as daily headaches, sinus trouble and numberous upper respiratory infections.  In addition, she has had severe swelling in her left ankle and pain in her left foot. The most recent information received on 02/25/2002, did not specify the outcomes of the reported events.  Information received 02/11/2002 indicated that daily headaches persisted.  The outcomes of the other reported events was not provided.  The vaccine provider considered the bilateral calf and foot pain, arthralgias, upper respiratory infection, and possible Lyme disease to be incapacitatine/disabling." The follow up received on 6/13/02 states following the reported onset of adverse events, the vaccinee also experienced vertigo, conjunctivitis, depression, and epidermal inclusion cyst. On 3/14/00, the vaccinee received her first IM left deltoid dose of LYMErix at her request. The physician's note dated the same date, 3/14/00, indicated that the pt had a CT scan of her sinusus which revealed chronic sinusitis. On 4/18/00, the vaccinee received her second injection of LYMErix. The physician note indicateed the vaccinee was "here for Lyme." she also complained about being stressed out secondary to job and when she leva down the room spins more left side." She was diagnosed with vertigo and given prescriptions for Antivert 12.5 TID three times daily prn and Xanex 0.5TID three times daily prn. Additionally, she experienced bilateral calf pain and foot pain in May 2000. On 5/5/00, the vaccinee reported to her physician with complaints of "achiness." Examination revealed "congestion, yellowish nasal secreations bad cough." She was diagnosed with an upper respiratory tract infection and was started on Lavaquin 500 QD times ten days and Dimetane DC 2 QID four times daily. On 5/9/00, the vaccinee reported stating she "thinks she has Lymes disease. Wants retest for Lymes, gets achiness." The physician's assessment included "arthralgia" and a Lyme Western blot and arthritis profile and ESR were ordered. On 5/11/00, the Lyme antibody index was 8.78, Lyme antibody IgM was positive, Lyme antibody IgG Western blot was negative, 18 kD band present, and C-reactive protein was 4.0mg/L. On 5/11/00, she had a positive Lyme test. On 5/19/00, the vaccinee called the physician's office regarding her Lyme results and requested that the results be faxed to her rheumatologist. On 9/26/00, the vaccinee returned to her physician "to discuss and fill paperwork for her reaction after Lyme vaccine." The physician indicated she was seeing a rheumatologist and her "forms filled out." On 11/27/01, the vacciee underwent a bone density scan. The physiican's impression was "osteoporosis of the lumbar spine and osteopenia of the left hip." The follow up received on 7/1/02 states that on 1/17/01, the vaccinee reported to her primary care physician that she was "under a lot of stress" and requested antidepressant therapy, which was initiated. The results included "Degenerative changes are identified in the hip and lumbar spine which may cause overestimation of the bone mincras density. On 2/6/02, the vaccinee presented to her primary care physician with complaitns of "right eye red crust," nasal congestion, and sore throat for five days. She was diagnosed with conjunctivitis and prescribed gentamicin, opotnaimic drops. On 2/15/02, the vaccinee presented to her primary care physician with complaints of continuing sore throat for three weeks, post nasal drip, increased nasal drainage, and cough with yellow sputum. The vaccinee was diagnosed with pharyngitis and ceruminosis and was prescribed Cefzil. The most recent info received on 7/1/02 did not specify the outcomes of the reported events. The follow up received on 7/16/02 states rheumatoid factor was negative. Serum uric acid concentration and ESR were within the referance ranges. Antinuclear antibody titer was 1:40 with a speckled pattern. On 5/16/00, testing for HLA-DR4 and rheumatoid factor was negative. On 6/26/00, Lyme IgG and IgM Western blots were positive. On 9/28/00, Lyme IgG Western blot was positive and Lyme IgM Western blot was equivocal. On an unspecified date, the pt told the rheumatologist that she was treated "in November" with doxycycline and unspecified symptoms "got better." She stated that she started to feel swelling, ankle pain, leg pain, shin splint, leg swelling, hand pain and stiffness, and conjunctivitis. The pt stated that she "felt rotten" again in July 2000 and felt "achey, terrible headaches, malaise." The pt stated that she had an upper respiratory infection that was treated with unspecified antibiotics in July and August 2000. The rheumatologist made a diagnosis of Lyme disease. On 8/24/00, the rheumatologist prescribed Fefcin 500mg twice daily. A variety of serologies for Lyme disease were performed on 10/28/01. The laboratory's overall interpretation was "no evidence of seroactivity beyond that expected from the Lyme vaccine."