Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Spinal cord disorder, Vaccine positive rechallenge
Clinical narrative: Information has been received regarding a case in litigation concerning a 35 year old female with chronic back pain who on 29 Nov 1994 was vaccinated with her first dose of hepatitis B virus vaccine rHBsAg (yeast) (manufacturer unknown). On 08, Dec 1994 the patient experienced numbness, tingling and difficult writing. As a result of these symptoms. On 10, Dec 1994 the patient went to a Chiropractor. Then on 13, Dec 1994 the patient saw a physician due to complaints of "tension in her neck for the past month" as well as tingling in her left arm and hand and numbness in her right arm. Of importance was her sensation of having a band around her which was tightening. This was an indicator of spinal cord inflammation. The patient questioned the physician as to whether her symptoms could be related to her recent vaccination and reported that her symptoms wee worsening, especially her ability to write. The patient returned to the doctor on 16, Dec 1994 with parestnesias in her arms and legs and a tightness across her abdomen. The patient saw the doctor again on 19, Dec 1994 and 04, Jan 1995 without much change in her condition. It was reported that six weeks after vaccination she improved but still had some neck tightness and an increased sedimentation rate, a broad marker of inflammation. The patient received her second dose of hepatitis B virus vaccine rHBsAg (yeast) (manufacturer unknown) on 13, Jan 1995. She returned to the physician on 25, Jan 1995 stating that her symptoms had increased in the prior three days and complained of fatigue. The physician referred her to a a neurologist. On 08, Feb 1995, the patient was seen by a neurologist. On physical examination she had hypoactive reflexes and a positive ANA of 1:40. The diagnosis was cervical myelopathy temporally related to the hepatitis B vaccine. The level of the spinal lesion was C-6 or C-7; it was demyelinating. The patient returned to the neurologist on 16, Feb 1995 with some improvement in her condition, she could write a little better than before but could not hold a glass without dropping it. Her energy level was slightly better. She had mild impairment of fine movements in her right hand with 4-distal strength. An MRI revealed semi confluent areas of increased signal in her cervical spinal cord form C-3 to C-6, increased on T2 and enhanced with gadolinium. It indicated multiple lesions of both acute and subacute or non-enhancing lesions which showed a dissemination of the lesion activity over time. As of a doctor's visit on 08, Mar 1995, the patient's condition markedly improved; could write and turn on her car ignition with her right hand. Fine movements were normal. Her spinal tap results showed normal protein and glucose although her IgG index was elevated. The physician's impression was transverse myelitis (TK) with evidence of demyelinating disease in the CSF. Oligoclonal bands were present. On 24, Apr 1995, the patient again met with the neurologist who's impression was improving TM following hepatitis B vaccine. There was no definite evidence of multiple sclerosis (MS) at this time although they did not image the patient's brain. She was improving though subsequent visits did display some limitations of activity and walking  and some residual paresthesias and fatigue. The neurologi8st wrote and independent Medical Evaluation on 24, May 1995 in which he stated that, she had stable symptoms of TM caused by two hepatitis B vaccinations administered on 29, Nov 1994 and 13 Jan 1995; her condition was fixed and stable. In July of 1996 a couple of doctors wrote workmen's compensation claims for the patient and it was felt that she fit into the Category II rating of disability (permanent impairment). In late 1997, she developed lower extremity dysesthesias or funny feelings in her lower legs, a tingling sensation, indication theat she may have acquired a new lesion. On 20 Nov 1997, the patient began experiencing low back pain. On 29, Oct 2003, a physician question the original diagnosis of TM and stated that he felt the diagnosis was likely MS due to the recurrence of fatigue and abnormal immunoglobulin banding. It was also reported that evidence favors rejection of hepatitis B vaccine causing MS. Hepatitis B vaccine is a surface antigen and does not contain living or active virus. However, another physician reported that the patient did not develop MS in the 10 years since her TM began. Another physician could not find grounds for supporting a conclusion of causation and said that the patient's TM could be coincidental after vaccination. It was noted that this case was one of challenge/rechallenge in that the patient had the same response to hepatitis B vaccine two separate times, positive for rechallenge. It was said that the timing was appropriate for causation. Information received on 25, Apr 2006 revealed the following adverse events; left knee inflammatory arthritis (early January 2004). Transverse myelitis was considered to be disabling.