Age: 1.08
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Coordination abnormal, Difficulty in walking, Irritability, Laboratory test abnormal, Myoclonus
Clinical narrative: Information has been received from a physician and a pediatric neurologist concerning a 13 month old healthy male patient with no medical history and no known allergies who on 2/5/03 (also reported as 3 weeks ago) was vaccinated with a dose of varicella virus vaccine live (lot #643529/0598M. Secondary suspect therapy included vaccination on 2/5/03 (also reported as 3 weeks ago) with a dose of MMR (second generation) (lot #639036/0381L)(MSD). There was no illness at the time of vaccination. There were no concomitant medications. The pediatric neurologist reported that the child developed a neurologic illness. On 2/20/03 the pediatric neurologist examined the child and reported that the child had symptoms for 10 days. The neurologist reported that the child was irritable. On 2/15/2003, (previously reported as 02/10/2003) he developed severe ataxia, later experienced opsoclonus (also reported by the physician as abnormal eye movements) and myclonus. He was barely able to sit, could not stand or walk and had eating trouble. The child had received no medication for the symptoms at the parent's request. The child had no hospital admission at the parents' request. Treatment for these events included physical, occupational and speech therapies. It was reported that the child was slowly improving but the outcome was reported as not recovered. An MRI and other unnamed tests were done, but no results were reported. It was reported that the child was going to be scheduled for a one day hospital admission for a spinal tap on 5/1/03. Follow up information reported that the patient was hospitalized. Follow up lab evaluation from May 2003 revealed that final PCR results reported that the CSF was VZV negative. The patient's experiences were felt to be disabling. Additional information has been requested. Follow up received on 5/15/03 noted that the CSF specimen which was VZV negative was obtained on 5/1/03. Follow up info from a physician on 5/19/03 reported that the pt never was hospitalized at the parents request. The physician reported that the child was home and reported as "better" by the parents, however the physician was anxious to evaluate the child and the child was scheduled to be seen by the physician on 5/19/02. The pt's experience were felt to be disabling. Additional info has been requested. On April 10, 2003 a CT Scan with IV contrast of the chest was indicated to rule out occult neuroblastoma, results were negative and findings included: "Spinal Ct scan of chest was performed at 7mm intervals from the lung apices to the mid portion of the kidneys following IV contrast administration in soft tissue and lung windows. The thyoid gland is not enlarged. There are no axillary, anterior mediastinal, AP window, pretracheal, subcarinal hilar or azygoesophageal adenopathy. There are no lung masses or nodules. There are no focal consolidations or atelectasis. There are no pleural effusions or pleural thickening. The tracheobronchail tree is widely patent without any endobronchial lesions. The heart and great vessels are normal. The chest wall is unremarkable. The visualized included upper abdomen is normal. No significant abnormalities identified. Further clinical correlations are suggested. "On April 10, 2003, a CT Scan of the abdomen and pelvis was negative and findings included :Contiguous axial tomographic images were obtained at 7mm intervals throughout the abdomen and 5mm intervals through the pelvis after IV contrast administration. The lung bases are clear. The liver and spleen are normal. The pancreas, gall bladder, kidneys and adrenal glands are normal. There is mo evidence of intestinal obstruction of free area. There are no abnormal fluid collections, ascites, or lymphadenopathy seen. Evaluation of the pelvis reveals no significant abnormality identified. Further clinical correlations are suggested. "DNA analysis on May 01, 2003 included an EBV Viral LO, CSF that was "< 250 copies/ML" and there was no detectable EBV in the CSF to a sensitivity of 250 copies/ml." The MRI of the brain of Feb 21, 2003 was negative, findings included: "Sagittal images demonstrate intact corpus callosum. The optic chiasm and sella turcuca are unremarkable. The cerebellar tonsils terminate at the level of the foramen magnum. In the posterior fossa, the fourth ventricle is midline in position. Brain stem and cerebellum are unremarkable. There is no cerebellar- pomtine angle mass. Above the tentorium, there is no mass effect or midline shift or acute hemorrage or extraxial fluid collection or abnormal, enhancement. There is no MRI evidence of acute infarction. Visualized paranasal sinuses are clear."; "Urine VMA, etc. "was negative. EEG was negative. Follow up information from a physician on May 19, 2003 reported that the patient never was hospitalized atthe parents request. The physician reported that the child was home and reported as "better" by the parents, however the physician was anxious to evaluate the child and the child was schedule to be seen by the physician on May 19, 2003. According to information received on Jul 17, 2003, the patient had not yet recovered. Follow up information on July 25, 2003 revealed that the child was not much improved and was now being taken to a specialist in opsoclonus and myoclonus. The specialists' theory was that "the neurological syndrome is being caused or was being caused by a neuroblastoma that has probably now gone into spontaneous remission". It was noted that the child had not yet been examined by the specialist. The patient's experience were felt to be disabling. Additional information is expected. Follow up on 08/22/2003: "Follow up information on 08/06/2003 from the pediatric neurologist indicated that the parents of the child were choosing at the present time not to go and see a specialist in opsoclonus and myoclonus.  Information received on 08/07/2003 indicated that the "baby cannot walk", "now has speech delay" and there was no change in the "opsoclonus-myoclonus".  It was also noted that the "severe ataxia/opsoclonus" was decreased "slightly" and that the child was being treated with "IVIG".  Additional information received on 08/07/2003 indicated that the child's parents wanted to try another course of IVIG" (scheduled for this week)" before they go to see the specialist in opsoclonus and myoclonus.  It was also noted that "they are very afraid because he recommended chemotherapy".  The patient's experiences were felt to be disabling.  Additional information is expected."