Sex: M
Vaccine: HEPA
Symptoms: Cerebellar ataxia, Laboratory test abnormal, Nervous system disorder
Clinical narrative: Information has been received regarding a case in litigation concerning a minor male patient who was born a healthy, normal child, and who reached his developmental milestones at appropriate stages, who in late March 2002, was vaccinated with a dose of hepatitis A virus vaccine inactivated. The alleged result of the vaccination was that diagnostic studies revealed that the patient was experiencing serious side-effects including cerebellar ataxia due to the vaccine. Said defective condition of the vaccine cause the patient to suffer brain damage. Upon internal review, experiencing serious side-effects, cerebellar ataxia, and brain damage were considered to be other important medical events (OMIC). No further information is available.  Follow up on 11/26/03: "Info has been rev'd regarding a case in litigation from a physician concerning a 24 month old male with NKDA & no prior med hist who on 03/25/02 was vaccinated IM w/one dose of Hep A virus vaccine inactivated (Lot # 640835/1169L).  There were no concomitant medications and no illnesses at the time of vaccination.  It was reported that the child reached his developmental milestons at appropriate stages.  W/in days, the pt experienced "significant neurological impairment".  It was reported that diagnostic studies revealed that the child "was experiencing serious side-effects including cerebellar ataxia due to the hep a virus vaccine.  Said defective condition of the vaccine caused him to suffer brain damage."  The physician noted that he considered hospitalizing the patient.  The patient sought medical attention.  Follow up information from the physician noted that the patient was a healthy, normal child with no neurological symptoms who was immunized w/the vaccine to go on vacation w/his family.  W/in 5 hours post-vaccination, the pt became unsteady on his feet.  His condition worsened and w/in 3 days had had developed ataxia.  The child became totally disabled and was unable to speak, eat or walk.  The patient was hospitalized and had a work up was done.  He had two MRI's a CAT scan and some genetic testing.  All of the tests were wnl.  The pt did have oligoclonal bands, which were producing antibodies w/in the CNS.  The pt was treated with IV immunoglobulins to clear the antibodies.  He was seen 1 week after discharge from the hospital and was showing some mild improvement.  The physician reported that he has snt blood and spinal fluid for PCR analysis for hep A.  He reported that he hopes that the condition is self-limited and that it will run the course and the child will recover.  On 09/09/2002, additional f/u info was received from the physician stating that the patient has severe acut cerebellar ataxia.  The patient has completely lost the ability to feed himself and to walk.  He has fallen and broken an arm due to the ataxia.  The patient had been admitted twice to the hospital for IVIG tx.  On 12/19/2002, additional f/u info was received from the physician stating that the pt's medical condition was improving.  The child was now feeding himself, walking 10-20 steps and sleeping through the night.  The physician also reported that he was "very comfortable with the pt's diagnosis of cerebellar ataxia, based on the clinical findings and that the ataxia as far out of proportion to the other symptoms. Ruling against a diagnosis of encephalitis are the results of the pt's tests including the fact that his CSF was (-) and an elevation in the oligoclonal bands."  The physician feels that this cas eis vaccine related.  On 12/20/2002, it was reported that there was an insufficient amount of specimen to received results of the PCR analysis for hep A.  Follow up info indicated that the pt's cerebellar ataxia has significantly improved.  The nurse reported that the pt "only sometimes walks with an unsteadiness on his feet".  She also reported that the patient recovered completely from difficulties w/speech and the broken arm.  Please see the lab section for all relevant lab results.  Additional f/u info from medical records indicated that the child fell from his bed injuring his right forearm on 08/21/2002.  He was splinted and found to have a "both bone forearm fracture".  The child presented to the office for evaluation . It was reported that the child was on an oral antibiotic at that time for a new onset of a right ear infection that began on 08/21/2002.  The extremity exam revealed mild deformity w/some ecchymosis over the mid and ulnar aspect of the forearm.  There was a good palpable pulse and he ahd spontaneous motion of his digits.  There was no elbow or shoulder tenderness.  The remainder of his musculoskeletal exam and all other physical exams were normal.  X-rays were taken of the right arm and showed "both bone forearm fracture" with about 20 degrees of angulation.  The radial fracture is more proximal thn the ulna.  There was no significant displacement and the left forearm films were negative.  The child was placed in a long arm splint and was scheduled for closed reduction and casting under anesthesia.  The procudure was done at day surgery on 08/23/2002.  They performed a "cloased reduction casting of right forearm fracture".  The report indicated that the child never broke bones before, never wore a caose or brace and never had problems or complications w/surgery, anesthesia, infection, bleeding or other surgical complications.  The cerebellar ataxia, upper limb fracture, fall, impaired self care, speech disorder and physical disability were considered to be disabling.  The brain damage and serious side effects were considered other medical events (OMIC).  The follow up info rec'd on 11/12/03 contained the following adverse experiences: ear infection (08/20/2003).  Additional info is not expected."  Follow up on 12/05/2003: "Follow up info received on 11/12/03 contained the following adverse experiences: ear infection (08/20/03).  The follow up info received on 11/18/03 contained the following adverse experiences: upper respiratory infection (04/18/2002); viral infection (04/18/2002, 05/02/2002, 08/12/2002). Additional information is not expected."  Follow up on 11/02/04 states: "The follow up information received on 11/12/03 contained the following adverse experiences: ear infection (08/20/03). The follow up information received on 11/18/03 contained the following adverse experiences: upper respiratory infection (04/18/02) and viral infection (05/02/04 and 08/12/02). Follow up information received on 12/22/03 contained the following adverse experiences: croup (02/18/03); nausea (02/14/03); vomiting (02/14/03); diarrhea (02/14/03); hyperactivity (05/12/03) and left earache (02/18/03). The follow up information received on 02/19/04 contained the following adverse experiences: trouble sleeping (07/00/02). No further information is available. All medical records will be provided upon request."