Sex: M
Vaccine: HEP
Symptoms: Antinuclear antibody positive, Arthralgia, Asthenia, Autoimmune disorder, Autoimmune hepatitis
Clinical narrative: optic neuritis symptoms; severe autoimmune reaction/autoimmune multiorgan involvement; autoimmune hepatitis; diagnosed with encephalopathy; Postural orthostatic tachycardia syndrome; systemic lupus erythematosus; redness at the injection site; arm soreness; Information has been received from a Ph.D. concerning her brother, a doctor who on 11AUG94 and 22SEP94 was vaccinated with his first and second doses of hepatitis b vaccine, recomb. After the first vaccination, the patient developed redness at the injection site, lethargy, arm soreness, and fatigue. The patient gradually recovered from these symptoms. After the second vaccination, he became very ill and had not yet recovered. He experienced severe joint pain, vision impairment, impairment of cognitive function, severe lethargy, and developed a facial rash. Based on the results of blood tests (anti-nuclear and anti-Smith antibodies) conducted in December 1994, the patient was diagnosed with systemic lupus erythematosus. In December 1994, the patient was prescribed methylprednisolone for the treatment of the lupus. He was prescribed additional treatment with methylprednisolone on 14FEB95. The patient saw another physician on 01MAR95. The blood tests performed previously were repeated,  and the results were negative for lupus. The physician suspected the initial positive results were a laboratory error. The patient saw another physician, who diagnosed him as suffering from an episode of encephalopathy caused by vaccination with hepatitis b vaccine, recomb. Two additional physicians concurred with the diagnosis of encephalopathy. The hepatitis b vaccine, recomb series was discontinued. At time of the report, the patient had not recovered from the symptoms he developed following the second vaccination with hepatitis b vaccine, recomb. Follow-up information from a Ph.D. indicated that the patient experienced "severe, debilitating autoimmune side effects from the vaccine including serious rashes, joint pain, chronic fatigue, and other degenerative diseases including lupus like syndromes and multiple sclerosis like symptoms". Follow up information indicated that the patient had been affirmatively diagnosed with "POTS (an autoimmune cardiovascular neurological problem)."  Another patient was also reported.   Subsequently, the patient's experience was reported in a published article. The article stated that the patient was left permanently and totally impaired.  Follow-up information was received on 29-OCT-2024. Literature Report. This literature marketed report has been received from the authors of a published literature article, titled as stated above and refers to a patient of unknown gender and age (previously reported as male) (case in litigation).    On an unknown date, the patient experienced postural orthostatic tachycardia syndrome (POTS). While the patient had POTS, this was a secondary cause due to autoimmune multiorgan involvement, including hepatitis. The patient received compensation for injury caused by the hepatitis B vaccination. The outcome of the events was not provided. The events were considered as related to hepatitis B vaccination by the court.  A copy of the published article is attached as further documentation of the patient's experience.  Upon internal review, the events of encephalopathy, systemic lupus erythematosus, optic neuritis, autoimmune disorder and autoimmune hepatitis were cosidered to be medically significant. According to previous versions, only the event of systemic lupus erythematosus  (SLE) was considered disabling. The event of injection site erythema was updated to vaccination site erythema due to updated coding convention.   Additional information is not expected.