Age: 11.0
Sex: M
Vaccine: RAB
Symptoms: Drug administration error, Dyskinesia, Headache, Laboratory test abnormal, Nausea
Clinical narrative: Information has been received on 9/24/02 from the patient's mother concerning her 11 year old son who was administered with the Imovax Rabies and Imogram series, which started on 7/22/02 after being bitten on the thumb from a rabid bat. The Imogram was administered in the gluteal region and thumb, and the Imovax was administered in the thigh for the series. Patient developed nausea, vomiting and diarrhea after receiving dose #2 of the series. The nausea occurred daily. The diarrhea subsided gradually until the third dose. Patient's mother reported that she was informed by the ER personnel that patient needed to restart a new series approximately on 9/1/02 since the previous doses were administered in the thigh rather than in the deltoid area. She also stated that she called the CDC and the CDC also recommended restarting the vaccine series. Patient started the second series at that time in deltoid. After dose #2 of the second series, patient experienced severe headaches, vomiting, stomach pain, and tremors that have continued to present time. He is due for last dose tomorrow 9/25/02. Patient was transported by ambulance from school to the hospital on 9/21/02 due to severe headache, tremors, vomiting, and severe stomach pain. It was thought that he was having seizures. Electroencephalogram was negative. A spinal tap was performed to rule out rabies. CAT scan was negative. The patient's rabies titer was 1:6800 on 9/9/02. The patient was admitted to the hospital on 9/9/02 for severe head pain, blurred vision, confusion and dizziness for 4 days. Adverse events have been medically confirmed with the ER director on 9/26/02. The lot number for the second series of Imovax Rabies vaccine was U0595-2. The patient did not receive the last dose of the second series. Additional information is requested from the hospital's medical records department According to information provided by the MIS department on 9/30/02: a telephone conversation occurred on 9/3/02 between patient's physician and a manufacturer representative. Manufacturer representative informed patient's physician that he felt the patient would probably have an adequate immune response to the series and recommended performing a rabies titer. From additional information received on 9/25/03 through telephone conversation with the physician's medical assistant, it was reported that the patient was seen in the ER on 7/23/02, 7/25/02, 7/26/02 and 7/31/02. He was also seen in the ER on 8/7/02 and 8/21/02, and again on 9/9/02 and 9/10/02. He was admitted to the hospital on 9/10/02 and discharged on the 9/11/02, then readmitted on 9/13/02 and discharged on 9/14/02. the suspect product was amended to include only the IMOVAX administered during the second series and the adverse event coding was updated. No further information is anticipated, this case is considered closed. From additional info received on 10/1/03, hospital records were provide from 7/31/02. 9/10/02 and 9/14/02. The pt was initially seen in the ER after being bitten on the right thumb by a bat on 7/22/02. It was reported that the animal tested positive for rabies. He was seen in the ER on 7/23/02, where he received an initial dose of Imovax Rabies and Imogam. He returned to ER on 7/25/02, complaining of diarrhea over hte past two days and a mild stomach ache. At the time it was noted that he had swollen glands in the throat. A group A strep screen was negative and alkaline phosphatase was elevated at 326. On 7/26/02, he was administered a second dose of Imovax, T1289, in the right leg. On 7/31/02, it was reported that the pt was seen in the ER to receive a third dose Imovax. At that tie he complained of stomach problems and was diagnosed with dyspepsia, for which he was treated with Pepcid. It was noted by the ER physician that the pt had "always had stomach problems" and in the past has been on Zantac and othe related medicines for inflammatory bowel disease. The pt was reported to have a history of ADHD, which was diagnosed at the age of six and for which he takes Adderall 20mg. Additionally, he had a history of a heart murmur. As noted previously, the pt began a second series of rabies vaccinations on 8/7/02. The second dose of the second series was given on 8/21/02 and wsa the last of the series. The pt was seen in the ER on 9/9/03 complaining of feeling weak. It was also noted htat the pt was acting confused, had nausea and vomited once the previous evening. He also complained of having a headache. He was treated with IV fluids of 1/2 NS at 200 cc/hr., Tylenol 500 mg orally, morphine sulfate 2mg, and Phenergan 12.5mg IV. A CAT scan of the head was performed and wanormal. Cerebrospinal fluid examination was normal. The pt's serum glucose level was elevated at 115, but was within normal limits following day. A history and physical examination dictated on 9/10/02 noted that the pt had no known drug allergies and there is no family history of childhood illnesses. On 9/13/02, the pt was admitted to hospital after haivg a two day history of nausea and vomiting. He had been seen by his primary care physician the previous day and had been prescribed Phenargan 25mg orally two times daily and Fioricet twice a day. On 9/13/02, the pt's mother stated that she had noted some seizure like activity, which included jerking and loss of bowel and bladder control. There was no loss of consciousness and she stated that he could talk during the shaking episodes. The seizure like activity was observed by the ER physician and was resolved with painful stimulation. The pt had complaints of severe headache and severe abdominal pain with nausea and vomiting. The admitting diagnoses were status post rabies exposure, seizure like activity, nausea and vomiting. The neurological physical exam showed good strenght and tone in all four extremities, 2+ deep tendon reflexes/globally. The pt was treated with IV fluids, IV Phenergan and alternately Tylenol and Motrin. Lab tests showed no Salmonella, Shigella, Camplobacter or E Coli. The glucose was slightly elevated at 115, chloride was slightly elevated at 110, creatinine was 0.5, alkaline phosphatase was 287. The rest of the chemistries were within normal limits. The physical examination was benign. The blood count was essentially normal. The urine drug screen revealed positive amphetamines and positive opiates, both related to medications that he had been taking. THe spinal fluid analysis and urinalysis was essentially normal. The EEG description showed htere were no areas of any focal slowing and no evidence of any epileptiform activity. Hyperventiliation wa not performed. Photic stimulation elicits a minimal symmetrical driving response. He was discharged on 9/14/03 and discharge diagnoses included status post rabies exposure, possible pseudoseizures and conversion disorder. It was not reported whether the pt recovered from these adverse events.