Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Computerised tomogram abdomen abnormal, Computerised tomogram abnormal, Flatulence, Gallbladder disorder, Gastrointestinal disorder
Clinical narrative: Initial report received on 24 May 2010 and follow-up information received on 26 May 2010 from an investigator in the trial. A 74 year old male subject was diagnosed with a cholecystitis and small bowel obstruction on 29 April 2010 i.e. 195 days after receiving a first dose of an intramuscular injection of INFLUENZA VIRUS VACC TRIVAL A AND B HIGH DOSE, SUBVIRION-U or FLUZONE SV 2009-2010, in left deltoid, on 16 October 2009 (UD1231). The subject had a medical history chronic hepatitis C, in remission after interferon, major depressive disorder, hypertension, right retinal detachment, adenomatous colon polyps, with most recent colonoscopy in 2007, psoriasis, erectile dysfunction, low testosterone and was a smoker. The subject was concomitantly on Clonidine, BENICAR, NORVASC, RISPERDAL. The subject was presented to primary care physician on 29 April 2010, with a three day history of intermittent crampy abdominal pain with associated nausea and some vomiting and was admitted in the hospital on the same day i.e. on 29 April 2010. The subject was then sent over the emergency room, where CT scan was performed, which revealed evidence of a moderate small bowel obstruction. Other significant findings were elevated white count, elevated creatinine, mildly elevated bilirubin, and evidence of some volume depletion and probable pre-renal azotemia. The subject's pain had been only mild and intermittent in nature, and this had not been the predominant complaint that he has experienced. The subject stated that he had not been able to keep any liquids down. On 29 April 2010, subject was seen in the emergency room with a white count of 16,900 and a marked left shift, with a hemoglobin of 15.9, and chemistries showing an elevated bilirubin of 2.1, an alkaline phosphatase of 86 (which was normal), SGOT and SGPT were minimally elevated. CT scan of the abdomen and pelvis was done which showed evidence of a small bowel obstruction with dilation of the proximal small bowel and no evidence of distention of the distal small bowel. It was of significance that the subject had moderate distention of the small bowel loops measuring up to 4cm. The distal small bowel loops were decompressed. The findings were suspicious for small bowel obstruction. Transition point was seen in the left lower quadrant. The subject also had an ultrasound of the abdomen which indicated multiple stones and a thick-walled, nontender gallbladder, and a prominent common bile duct at 6.9 mm. Subject was taken to the operating room and had lysis of adhesions, released of small bowel, "cholecystitis for a chronic cholecystitis", and ventral umbilical hernia repair. Lab data included postoperatively subject had a significant amount of ileus, probably at least 7-8 days. A repeat CT scan was done, which showed that he still had a partial small bowel obstruction. During subject's ileus, subject was supported with some total parenteral nutrition. Subject's pain was well managed. The subject had had bowel movements, flatulence, positive bowel sounds, and was tolerating his diet well. MR abdomen without contrast-exam done on 30 April 2010, Impression: several small gallstones are identified within the gallbladder. However, there was no evidence of gallbladder wall thickening. The common bile duct was within normal limits. A tiny density, measuring approximately 2 millimeters, was identified within the common bile duct in its mid portion, likely artifactual, less likely a tiny nonobstructive stone could not be completely excluded. Small bowel only exam done on 30 April 2010, impression: suggestive of high-grade, partial distal small bowel obstruction as described. Abdomen single AP-1 view exam done on 1 May 2010, findings were gastrografin contrast was noted throughout the colon. Multiple distended loops of air-filled small bowel are also identified with several loops containing gastrografin contrast. Findings suggest partial high-grade distal small bowel obstruction. PICC line was placed on 4 May 2010. CT abdomen & Pelvis with contrast, exam done on 6 May 2010 Findings were a small right pleural effusion is present, Liver: unremarkable. No evidence of obvious mass or intrahepatic biliary dilatation. Gallbladder/biliary: Gallbladder had been removed. There were some scattered air bubbles and postoperative change in the gallbladder fossa. Surgical clips were present in that area. Pancreas were unremarkable. No evidence of obvious mass, pseudocyst or pancreatic calcification. Prior cholecystectomy. Continued evidence of scattered mildly dilated small bowel loops, although the colon was decompressed. A partial distal small bowel obstruction was not excluded, although the distension was less than was earlier the case. Scattered amounts of ascitic fluid are present both around the liver and in the pelvis in particular. The subject received corrective treatment with NG suction, IV hydration, intravenous antibiotics, potassium supplementation if necessary. MR cholangiogram and small bowel series. GI surgical consultation was done. The event of cholecystitis and small bowel obstruction was resolved on 8 May 2010 and the subject was discharged home on 8 May 2010. According to the investigator, the event was related to the study vaccine. The serious adverse event did not lead to the termination of the subject from the study. List of the documents held by sender: None.