Age: 22.0
Sex: F
Vaccine: HEP, SMALL
Symptoms: Hypoxia, Laboratory test abnormal, Lung disorder, Systemic lupus erythematosus
Clinical narrative: Information has been received from a physician concerning a 22 year old female who in 4/03, was vaccinated IM with a dose of hepatitis B virus vaccine, 1 ml/once. Concomitant therapy included 4 other vaccines (therapy unspecified). Other concomitant medications was unknown. Subsequently, the patient died. The cause of death was unknown. There were no diagnostic lab test performed. Unspecified medical treatment was sought. There was no product quality complaint involved. Additional information has been requested. Follow up on 02/13/04: "Additional follow-up information from a news release an internet site indicated that the pt received five vaccinations on 03/02/03 and that she developed a complex set of pulmonary, neurological and other symptoms and died on 04/04/03.  "She died due to a severe inflammatory process affecting her lungs, findings consistent with a diagnosis of systemic lupus erythematous (SLE) of lupus".  It was noted that neiture the pt nor her physicians know that she had an underlying immune system disorder.  Two independent panels of medical experts concluded that the "vaccinations may have triggered an illness that ultimately led to the death" of the pt.  "The evidence favored a causal relationship, but the evidence was not conclusive".  The first panel reported that "the weight of available evidence favors acceptance of a sausal relationship betwen the immunization experience and the disease".  The second panel "differed slightly" on how to charactierze the relationship between the vaccinations and the pt's death.  Three members considered the relationship "possible", while two other members considered it "probable".  "Each panel said that it was unable scientifically to identify a specific vaccination as the possible cause since several vaccinations were administered at one time". Further follow up information from an internet site described two panels of civilian experts revealed that in addition to hepatitis B virus vaccine rHBsAg (yeast) and MMR, the pt's other concomitant vaccinations included anthrax, smallpox, typhoid and tuberculin skin test.  It was noted that the pt was "healthy" and had received "multiple vaccinations previously", including hepatitis B virus vaccine rHBsAg (yeast) (manufacturer unknown).  "Without any problem".  It was also noted that the pt had an "underlying undiagnosed disorder" and because she "received all of the vaccines the same day, the expert panels could not determine which of them might have contribued to her death".  The pt was treated for her illness at a clinic and nearby hospitals starting in mid-March.  She was treated by several medical specialists, including pumonology, neurology and infectious disease.  It was noted that the pt's condition worsened.  Specialists who later treated her at another clinic convered with other department of defense clinical experts and the CDC.  Lab studies indicated that the pt did not have meningitis, encephalitis or evidence of vaccine virus in her spinal fluid.  Anti-Ro antibodies indicated "an unusual pattern of antibodies".  After the pt died it was noted that further lab tests were performed (results not available at the time of this report).  The pt's death certificate listed the cause of death as "diffuse alveolar damage" and also mentioned she developed pericarditis.  Clinical experts on immunization reported that the "pericarditis developed late" in this case and "did not seem to be the main reason for her illness".  Other expert panels concluded that "vaccination may have triggered an illness that ultimately led to the death" of the pt.  "No evidence pointed to one vaccine over the others".  Upon internal medical review inflammation, neurological symptoms and other symptoms were considered other important medical events (OMIC).  Additional information has been requested.  Additional follow-up information was obtained from the internet at the following address: www.vaccines.mil.