Age: 82.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal distension, Atrial fibrillation, Cardiac failure congestive, Coronary artery embolism, Intestinal gangrene
Clinical narrative: This subject is an 82 year old male who was admitted to the hospital on 8/13/03 and died 2 days later on 8/15/03 while enrolled in RSV 11 study, with RSV vaccine or Placebo and Influenza vaccine. The subject received study vaccine on 10/31/02. Subject developed nausea, vomiting, abdominal distention and pain 286 days post immunization and was admitted to the hospital 286 days later on 8/13/02. Subject was diagnosed with gangrene of small bowel, congestive heart failure, chronic atrial fibrillation, embolus of the superior mesenteric artery. Treatment included the medication, Restoril, Remeron, Protonix, Lasix, Lisinopril and IV antibiotics. Subject died 2 days later on 8/15/03. The causality has not been assessed by the investigator as of yet, additional information has been requested. On examination, he was mentally alert. He was complaining of quite a bit of pain. His abdomen was distended. At first, bowel sounds were absent. Note, he gave a history of passing flatus on the day prior to admission and having a bowel movement, but none on the day of admission. The patient was given IV fluids. He was not given antibiotics at first. His Coumadin was discontinued. His other medications continued were appropriate. On the morning of 8/14/03, the patient had had nasogastric suction overnight, which was fairly profuse. He was still complaining of abdominal pain but stated that he had passed some flatus during the night. His white count became elevated. He was therefore placed on broad spectrum antibiotics. We discussed the possibility of proceeding with surgery with him. He said he wanted to avoid this if at all possible. A CT of the abdomen was obtained, and this suggested proximally dilated bowel and collapsed distal bowel. Our impression at this time was on of an incomplete small bowel obstruction, particularly in view of the fact that he recently passed flatus, and there was a considerable amount of gas in the colon. The patient was treated overnight. On the morning of 8/15/03, however, his white count had dropped only minimally. He was still complaining of pain. His abdominal distention had not decreased. His nasogastric suction was quite profuse. We recommended surgery. He discussed this with his daughter in some detail and considered not giving permission but finally relented. He was aware that he was at high risk and that even offered his comment that he thought he would not survive the surgery. He was taken to the surgical area where an A line and a Swan-Ganz catheter was placed. He already had a Foley catheter in situ. He was taken to surgery. At the time of surgery, ischemia of the entire bowel was found in the distribution of the superior mesenteric artery. The bowel was clearly not viable. The abdomen was therefore closed. The patient returned to recovery room where he was kept on large doses of vasopressors but was maintaining inadequate blood pressure. He was kept on a ventilator. Later, after discussion with his daughter and on our advice, we discontinued the vasopressor, and within just a few minutes, he developed cardiac asystole. He was pronounced dead as 2:30 pm on 8/15/03. An autopsy was declined by the family.  A 15-day follow up report received 09/30/2003 adds: Final Diagnosis: 1. Gangrene of the small bowel. 2. Probable embolus of the superior mesenteric artery. 3. Chronic atrial fibrillation. 4. Congestive heart failure. 5. Recurrent pleural effusions.