Age: 37.0
Sex: M
Vaccine: HEP
Symptoms: Dyspnoea, Headache, Systemic lupus erythematosus
Clinical narrative: The pt reported that he received his first SC injection of Engerix-B on 05-APR-1997 and immediately experienced a "really bad" headache. Treatment and outcome of the headache were not specified. The pt reported that he received his second SC injection of Engerix-B on 17-MAY-1997. Approximately one month after receiving the second injection, in June 1997, he reportedly began to experience weakness, loss of memory, shortness of breath and confusion. He made "several trips to his doctor's office for tests". The pt reported that diagnoses of "drug-induced lupus" and an autoimmune "blood disorder" (NOS) were made. Treatment of these events was not specified. He reported that in June 2001, he experienced a "small" stroke and was hospitalized for two days. The pt reported that "the doctor thinks there may be some genetic sensitivity to the vaccine", since his mother experienced autoimmune disorders following the receipt of a different brand of hepatitis B vaccine. As of 27-NOV-2001, the "drug-induced lupus" and autoimmune "blood disorder" were ongoing. the outcome of the stroke was not specified. Information was received from the vaccinees' current primary physicians on 9/9/02. The physician stated that he first saw the vaccinee on 3/8/01. At that time, he reported "fainting spells/dizziness" and "blurred vision/double vision". He reported that he hit his head on concrete at 2 years of age. At 4 years of age, he began having migraine headaches, which continued until age 16. At age 16, a diagnosis of temproal lobe epilepsy was reportedly made. The vaccinee stated that in 2000, "the question of epilepsy arose again". The vaccinee was taking Valium for "stress" at the time of the initial evaluation. The physician's assessment was "anxiety disorder per history." He prescribed Effexor. On 4/9/01, the vaccinee reported that Effexor made him dizzy; Effexor therapy was discontinued. The vaccinee returned to his primary physician on 6/8/01. He reported that he began "having visual changes" in approximately 1999. "Had EEG, which was normal and then one year ago had questions of seizures and was seein in ER for a visual loss, which lasted half hour and was assoicated with headache. Was diagnosed with ocular migraine and the episodes occurred once or twice a month." The vaccinee reported that he experienced visual change, headache, loss of feeling in the left hand, anxiety, "respiratory distress", and left-sided facial weakness on 5/30/01. He was evaluated in the emergency room. CT "was found to be normal". The vaccinee reported that while on a trip on 6/6/01, he expereinced visual changes, headache, confusion, inability to read, and was flaccid. He was evaluated in the emergency room. all symptoms resolved within one hour. The "working" diagnosis was reportedly hemiplegic migraine, and a physician prescribed Depakote. The vacccinee's primary physician referred him to a local neurologist. The vaccinee was evaluated byt he neurologist on 6/15/01. at that time, the vaccinee reported that he had begun having headaches in 1998, and for the past year they had been occurring once or twice per week. The headaches were sometimes preceded by kaleidoscopic colors and visual loss, described as "seeing only parts of objects." He reported that he was unable to tolerate fluorescent lights. The vaccinee reported that he had been given a diagnosis of ocular migraine. The vaccinee described the episode during his trip as occuring on 6/7/01 and as "another episode of visual disturbance when he saw kaleidoscope colors. He closed his eyes and went to sleep and half an hour later whe woke up feeling confused. He noticed that he could not feel his left upper extremity. Subsequently, he had a feeling of generalized weakness and numbness....He couldn't recall the name of his wife an was unable to read signs. He was also noted to be hyperventilating. He was admitted overnight. Reportedly he had neurologic evaluation was noted to have cognitive impairment. Gradually these symptoms resolved. He was told the he was a hemiplegic migraine." The vaccinee also reported loss of fluency of pseech, word finding difficulty, mood swings, loss of balance, stumbling, and easy loss of temper since 6/7/01. The neurologist's impression was "migraine complicated by transient ischemic episodes including an episode of confusion. he has noted improvement in his headache since he was started on Depakote. The last few episodes may have been related to excessive use of caffeine, stress, and irregular sleep habits. Currently there are no focal or lateralizing neurologic deficits noted. MRI studies, including MR angiogram, cannot be obtained as he has a history of back surgery with placemtn of metallic plates." The neurologist recommended continui9ng Depakote therapy and prescribed aspirin 325mg daily. On 7/25/01, the vaccinee returned to his primary physician, after taking Depakote for approximately six weeks. He reported myalgias and arthralgias. He stated that laboratory anaysis performed by his neurologist revealed "elevated ANA (antinuclear antibody) titers and decreasing platelet counts." Please see laboratory data section. The primary physician wrote, "concern is that these may be medication induced." The primary physician discussed this with the vaccinee's neurologist, who referred the vaccinee to a rheumatologist. Depakote therapy was discontinued on an unspecified date, and Depakote was added to the list of allergies in the vaccinee's medical records. The vaccinee was evaluated by the rheumatologist on 7/31/01. The vaccinee reported "some sun sensitivity" at that time. The rheumatologist noted. "He has possibly had thrombocytopenia in the past but his last platelet count in June was normal." The vaccinee "has intermittent arthralgias/myalgias with some activity. His most significant complaints of late have been his knees, bilateral heels and occasionally the left elbow." He reported a 20-pound weight gain over the previous six weeksn and "intermittent difficulty with hearing loss". No abnormalities were noted on physical examination. The rheumatologist's impression were "1. Positive ANA, no physical evidence of collagen vascular disease. 2. Maybe associated antiphospholipid syndrome. 3. History of migraines and associated seizures." The rheumatologist referred the vaccine to a hematologist, to evalute the possibility of antiphospholipid syndrome. On 8/15/01, the neurologist recommened that the vaccinee use continuous positive airway pressure (CPAP) for the treatment of obstructive sleep apnea. The vaccinee could not tolerate this, so bilevel positive airway pressure (BPAP) was recommended. The vaccinee was subsequently evaluated by a hematologist. Date of first evaluation was not provided. The vaccinee returned to the neurologist on 12/14/01. The physician wrote, "reportedly his mother had developed drug induced lupus following a hepatitis b vaccination. When he learned about this from her, it occurred to him that he had also received a hepatitis b vaccination about three years agao. He wonders if he has developed drug induced lups from this vaccination." The neurologist's impressions were "1. MIgrainses and migraine related phenomena including episodes of confusion. He had a previous normal awake and sleep EEG. 2. Obstructive sleep apnea syndrome. #. Antiphoapholipid antibody syndrome." The neurologist noted that the aspirin dosage had been decreased to 81mg daily, and he recommended continuation of that. The vaccinee returned to the neurologist on 4/18/02. The neurologist wrote that the vaccinee was not able to tolerate bilevel positive airway pressure for the treatment of obstructive sleep apnea. "He is aware of the significance of his sleep apena syndrome and its impact on his migraines and other symptoms which have been fetl to represent transient ? attacks or migraine related phenomena. He is aware that sleep apena syndrome is a risk factor for stroke. He is currently on Aspirin 81mg p.o. qd. Plavix was being considered for his antiphospholipid antibody syndromre, however, he has been concerned about the side effect of thrombotic thrombocytopenic purpura that has been reported with the use of Plavix, hence he has opted to stay with Aspirin". The neurologist impressions were 1. Migraine and migraine related phenomena vs. transient ischemic attacks. 2. Obstructive sleep apnea syndrome. 3. Antiphospholipid antibody syndrome." The most recent information, received on 9/9/02, indicated that migraines, possible transient ischemic attacks and anitphospholipid syndrome persisted as of 4/18/02. "Drug induced lups" is considered medially serious. Additional info was received on 7/15/03, indicated that the drug-induced lupus and lupus anticoagulant persisted as of 7/15/03. Information received on 9/9/02 indicated that migraines, possible transient ischemic attacks, and antiphospholipid syndrome persisted asa of 4/18/02. "Drug-induced lupus" is considered medically serious (OMIC).