Age: 23.0
Sex: F
Vaccine: RAB
Symptoms: Injury, Laboratory test abnormal, Polyarteritis nodosa, Rash, Thyroid disorder
Clinical narrative: From information received via telephone on 10/31/02, it was reported that a 23 year old female student was vaccinated with Imovax Rabies, lot # U8971 on 10/17/02 (second dose in pre-exposure series). On 10/26/02, the patient developed low back pain and joint pain in her knees, ankles and elbows. The patient self-medicated with ibuprofen. The patient also reported that she developed a rash on both lower legs. She was evaluated by a physician and diagnosed with possible Immune Complex-like reaction and petechiae of both lower extremities. Laboratory tests revealed that the patient had an elevated CR protein level, elevated globulin level, and sedimentation rate of 37. Her basic chemistry was reportedly normal. No further information was provided at this time. It was not reported whether the patient recovered. From additional information received on 4/3/03 from the physician, it was reported that the patient was taking oral contraceptive pills at the time of vaccination. Reportedly, the patient has an excellent history of health and had no previous allergies. The patient did have a thyroid injury, due to a blow to her neck by a horse in 2002. Per the reporter (physician) dated from 1/29/03: The patient continues to have discomfort in elbows, wrists if does push ups (patient is in ROTC program). No joint swelling. She has since had a left total hemithyroidectomy on 12/7/02 with diagnosis of adenomatous hyperplasia of thyroid following her injury 2002 (horse kicked patient in neck). Recovery has been uneventful. On 10/31/02, Parvovirus IgG antibody was positive. Reportedly, the patient has improved. On 8/9/04: A new version was created to correct the adverse event screens from serious to non-serious. No new information was reported. From additional information received on 9/17/04 from the reporting physician, thisc ase has been upgraded to serious, as the patient's adverse reactions resulted in a three week hospitalization and were considered to be life threatening events as per the physician. It was reported that the patient was diagnosed with polyarteritis nodosa sometime after receiving her second dose of IMOVAX RABIES on 10/17/02. The exact onset date was not reported. She was hospitalized for three weeks in the summer of 2003 and underwent chemotherapy for polyarteritis nodosa. The patient then developed severe hypertension. At the time of this report, the patient is not considered to be in remission and her current medications include CellCept 800mg, twice daily, Neurontin 500mg, three times daily, Altace 5mg three times daily and labetalol 200mg daily. It was not reported whether the patient completed the IMOVAX RABIES series. She has since received a first dose of Hepatitis A vaccine (lot number and manufacturer not reported) in March 2004. It was reported that the patient has currently returned to her university to resume studies. Her recovery statys still remains as not recovered and the reporting physician was not sure whether these events resulted in a permanent disability.  Follow up on 10/29/04 states: "From additional information received on 10/21/04 from the reporting physician, it was reported that the second dose of IMOVAX RABIES was administered in the right deltoid and that the onset of polyarteritis nodosa symptoms began in mid to late October 2002. The pt did not complate the rabies series. Per the reporter, the pt's hypertension is currently under control with medication. The reporter spoke with the pt on 09/13/04, and she reported that she was doing well, but was not in remission. Her current medications include CellCept, Neurontin, Altace and labetalol. It is unknown if the events resulted in a permanent disability." From additional information received on 8NOV2004 from a physician, the patient's address was provided. Per the reporter, the lot number administered was 904060, not U8971 as previously reproted. Lot 904060 does not match the Manufacturer's product. The reporter also stated that the patient is on medication and in stable condition, but has not recovered from the events. Per the reporter, hospital discharge summary is not available.