Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Echocardiogram abnormal, Ejection fraction, Electrocardiogram normal, Gastrointestinal tube insertion, Glomerular filtration rate abnormal
Clinical narrative: Information has been received from an investigator concerning a 71 year old male with benign prostatic hypertrophy and chronic kidney disease stage 2 who on 14-FEB-2007 was vaccinated with ZOSTAVAX (Oka/Merck) (lot#: 656608/0032U). This report was part of a study. The patient was admitted on 25-FEB-2007 for slurred speech and found to have an ischemic bilateral lacunar cerebrovascular accident, and transferred to the Intensive Care Unit secondary to a second cerebrovascular accident involving the right mid brain, pons and with extension to the right thalamus. On the second hospital day, he was found to be unresponsive. A repeat head CT demonstrated an acute infarct of the right pons and thalamus without extension, intracranial hemorrhage or dissection. There was atherosclerosis of the vertebral and aortic arch. The right vertebral artery was found to be smaller than the left and there was also age-related cortical atrophy. Atherosclerosis of the vertebral artery was thought to be the likely embolic source for this second event. A CT angiogram demonstrated occlusion of the right proximal posterior cerebral artery along the P1 segment although the distal right cerebral artery was patent secondary to communicating arteries. Because of this, he was started on anticoagulation with heparin. Carotid ultrasound was obtained which demonstrated no significant stenosis of the internal carotid arteries on either side, and there was bilateral antegrade vertebral flow. The NIH stroke scale was 15 on admission upon evaluation by the neurologist. He was given permissive hypertension and oxygen initially. He was also continued on full dose aspirin which was started upon admission to the hospital since he was not taking that at home. In addition, he was given lovastatin 40 mg p.o. daily. The patient had no significant changes in his neurological examination after admission to ICU. He was hemiplegic on the left side with significant sensory deficit and weakness. He was able to move his right upper and right lower extremities spontaneously against gravity and withdrew to noxious stimuli in all four extremities. However, he had no gag reflex and was very somnolent on examination, at times difficult to arouse. His pupils were bilaterally unequal with the right pupil approximately 4 mm and the left pupil approximately 2 mm, sluggishly reactive bilaterally as well. In addition, on 2/27/2007 he was found to have apneic episodes with Cheyne-Stokes breathing pattern, worrisome for central apnea. The patient was ruled out for myocardial infarction with negative enzymes per protocol, in addition to negative electrocardiogram. Echocardiogram on 2/26/2007 demonstrated an ejection fraction of 50-65% with normal LV function and no cardioembolic source. There was some aortic sclerosis without stenosis. He was given aspirin as above in addition to the statin as above. The patient had no history of diabetes but did have elevated fasting glucose on admission so he was given an insulin sliding scale and his fingerstick glucose was checked. He was also given D5 normal saline since he was not eating. Because his fingersticks remained stable, the insulin sliding scale and fingerstick checks were later discontinued. The patient had a baseline glomerular filtration rate of approximately 78 consistent with chronic kidney disease Stage 2. His creatinine remained stable during hospitalization and electrolytes were repleted as needed. He was given aggressive intravenous hydration given that multiple doses of contrast were given. The patient had no active issues and his temperature and white blood cell count were monitored without any significant signs of infection. The patient was made NPO and a nasogastric tube was initially placed to low intermittent suction. This was later changed to CORPAK in order to initiate tube feeding. He was given GI prophylaxis with famitodine (MSD). Patient was placed on heparin drip secondary to the thrombus as above. His hematocrit was assessed as stable. He was continued on SCD for prophylaxis and also given aspirin as above. The patient was diagnosed with status post bilateral lacuna cerebrovascular accident, status post right mid brain pontine thalamic cerebrovascular accident and chronic kidney disease, Stage 2. The patient died on 01-MAR-2007 at 20:50. The cause of death was haemorrhagic intracranial with likely herniation secondary to left mid-brain pontine and possibly thalamic stroke. Additional information has been requested.     11/5/08 Death Summary received from FDA.  Pt admitted 2/25/07 for slurred speech and found to have an Ischemic bilateral lacunar CVA. Found unresponsive on hospital day#2 and dx with acute CVA. Pt hemiplegic with significant sensory defecits and weakness. Apneic episode with Cheyne-Stokes breathing worrisome for central apnea. Gag reflex absent-place on aspiration precautions. NG tube placed for feeds. Place on comfort care only. Pt expired 3/1/07 with COD Intracranial hemorrhage with likely herniation 2' to left midbrain pontine and possibly thalamic stroke. 1/9/09-death certificate received-COD intercerebral hemorrhage,non-traumatic. acute ischemic stroke.posterior cerebral artery occulsion, etiology unknown.