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Life Threatening? No
Write-up: Information has been received from a pharmacy technician concerning a 75 year old (previously reported as "about 75 year old") female "in poor health" with heart problems and a history of stroke and other unspecified medical conditions who on 02-AUG-2007 was vaccinated with a dose of Zostavax. For an unspecified amount of time after vaccination the patient was observed for any reaction. The patient then left the pharmacy without any signs of an untoward reaction. Several days later the pharmacy technician read in the paper obituaries that the patient passed away on 06-AUG-2007. The cause of death was not reported. There was no product quality complaint involved. No further information was available. Additional information has been requested. 08/23/2007 Per email from FDA: A 75 y/o female in poor health with heart problem and a hx of stroke died 3 days after receiving Zostavax. Her name was in newspaper obituaries. She did not experience any immediate AEs after vaccination. Called Meck for follow up information including cause of death. 8/27/07 FDA obtained patient name & DOB from Merck. No autopsy was done. COD was intracranial hemorrhage. Merck will provide additional medical records. 9/7/07 Reviewed pcp medical records which reveal patient on chronic anticoagulant therapy for mitral valve replacement & was seen approx every 2 weeks for labs & eval. Weight & vital signs stable. 10/29/07 Reviewed Death Certificate which states COD as subdural hematoma with anticoagulation for valvular heart disease as contributing factor.
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