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Administered by: Unknown Purchased by: Unknown
Life Threatening? Yes
Write-up: Information has been received from an investigator concerning a 37 year old female with HIV and a history of migraine headaches and methamphetamine abuse for 20 years who entered a study. On 08-MAY-2009 the patient was enrolled in A5240 and vaccinated IM with the first dose of GARDASIL, 0.5ml, in deltoid. On 22-JUN-2009 the patient developed the following adverse events: altered mental status grade 3 (dysarthria, anomia, confusion); headache grade 3 (presented to HD 22-JUN-09 with AMS, HA). CT angle of head showed diffuse cerebral edema); left hand numbness grade 2. On 02-JUL-2009 the patient developed decreased neurological reflexes grade 4 (life threatening), pupils fixed and dilated bilaterally grade 4 (life threatening), and death. The report was as follows: The patient presented to emergency department on 22-JUN-2009 with migraine-like headache, left hand numbness, dysarthria and anomia. CT read as normal, patient discharged, the patient returned on 23-JUN-2009 with persistent headache, anomia. At that time, she was not on treatment for HIV and her CD4 count was 263. She was admitted to the neurology service and empirically treated with antibiotics for bacterial and HSV meningitis. Lumbar puncture showed borderline low glucose, elevated protein and a lymphocytic pleocytosis without red blood cells, CSF tests for EBV, HSV, VZV, Cryptococcus, VDRL, AFB smear were negative as well as CSF culture for bacteria, fungus and mycobacteria. CSF cytology was negative, flow cytometry was not performed. JC virus PCR was ordered, but results not reported. Toxoplasma IgG was negative. Blood cultures, coccidioidomycosis titers, serum cryptococcal antigen, RPR were all negative. Prior quantiferon testing in 2004 was positive without subsequent isoniazid treatment chest X ray during admission was negative as were 2 sputum for AFB smear and culture. MRI showed diffuse cerebral edema with leptomeningeal enhancement. Repeated lumbar puncture showed normalization of glucose. During the hospitalization, her symptoms had improved. Discharged to home 29-JUN-2009 with diagnosis of resolving viral meningitis vs. HIV encephalopathy. Initial consideration had been made of TB meningitis but her symptomatic improvement without TB treatment made this less likely. HIV treatment was not started during the hospitalization but was planned pending reevaluation after discharge and final review of all cultures and pending test. Re-presented emergency department on 01-JUL-2009 complained of worsening headache, symptoms and confusion; discharged as it was thought her symptoms were consistent with previous status. Returned to emergency department that night with confusion and altered mental status. At 5 AM on 02-JUL-2009, she acutely became unresponsive in the emergency room, requiring intubation and was noted to have fixed, dilated pupils bilaterally. Emergent head CT revealed diffuse cerebral edema and herniation. Pronounced brain dead of unknown cause on 02-JUL-2009. Post mortem pending, would take up to 8 weeks at this site before results were available. Relevant diagnostic tests conducted at the time of death occurred were as follows: On 22-JUN-2009, computerized tomography (CT, CT Scan, CAT Scan) of head: diffuse cerebral edema: 3 am left ICA aneurysm; bilat symm, optic nerve sheath distention. On 23-JUN-2009, magnetic resonance imaging (MRI) of brain: with contrast, diffuse supratentorial leptomeningeal enhancement, consistent with leptomeningitis. Diffuse sulcal effacement. Vague non enhancing T2/FLAIR hyperintensity multiple sites suggestive of infectious or toxic/metabolic etiology or PML. 02-JUL-2009, computerized tomography (CT, CT Scan, CAT Scan) of brain, profound diffuse sulcal effacement throughout cerebral hemispheres and posterior fossa. Severe downward tonsillar herniation and severe upward transtentorial herniation with compression of brainstem. The reporting investigator felt the event death was not related to study therapy. Study therapy ass
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