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Life Threatening? No
Write-up: Case number PHHO2011US07292, is an initial report received on 26 Apr 2011, from a clinical study. This 70-year-old male subject was enrolled in a study. The subject''s medical history included hyperlipidemia and cancer of left breast. Concomitant medications included Simvastatin. The subject received the study vaccine on 03 Sep 2010 at 13:15. On 18 Apr 2011, the subject was taken to the hospital for evaluation of dizziness and headaches. The same day, the subject experienced botulism and quadriparesis. The subject was unsteady on their feet and was weak in the upper extremities. The subject experienced progressive weakness and quadriplegia. The subject was seen by a neurosurgeon and neurologist. The subject underwent an MRI scan which showed spinal stenosis and multiple levels of degenerative disk with diffuse bulging and osteophyte formation. The investigator stated that per the neurosurgeon, did not cause the quadriparesis. An MRI scan of the brain revealed moderate microvascular disease. A CT scan of the head showed no evidence of acute cranial or intracranial abnormality. The subject was treated with Aspirin and DECADRON and some improvement in status was noted. The subject was placed on ''JV'' for atypical presentation of Guillain-Barre syndrome. The subject was started on Doxycycline. The subject had a CT myelogram, a lumbar puncture and their antibody cultures were collected. The patient''s protein was normal. In the subject''s CSF fluid it was noted that their glucose level was increased (assessed as not clinically significant by the investigator). On 21 Apr 2011, the subject was transferred to ICU and signed a DNR (do not resuscitate). The subject refused to be intubated and refused a N16 and foley catheter placement. The subject''s condition deteriorated with desaturation 100% and blood pressure dropped. The subject was started on a dopamine drip, maximum dose. The subject experienced respiratory muscle paralysis. On 21 Apr 2011, at 03:38am, the subject died. An autopsy was performed, and results are pending. The seriousness for botulism as life threatening and fatal, quadriparesis was disability and respiratory muscle paralysis was fatal. The outcome of the quadriparesis was condition deteriorating. The investigator suspected a relationship between the botulism, quadriparesis and respiratory muscle paralysis and the study vaccine. Follow up received on 04 May 2011: Patient''s sex corrected, lab tests updated, events updated, death details updated, treatments provided, causalities updated.
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