Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain, Back pain, Dyspepsia, Nausea, Pancreatitis acute
Clinical narrative: A 69 year old female received RSV Vaccine or Placebo and Influenza Vaccine on 10/10/03 and 205 days later on 5/21/03 developed acute Pancreatitis and was admitted to the hospital on 5/21/03. Patient experienced increasing abdominal pain and back pain, and was treated with Nexium, oxycontin and Colace. Discharged 5/25/03. Outcome: Recovered with residual effects (residual pain). The investigator assessed the event as possibly related to the study product. Follow up information received on 6/12/03: Patient was admitted to hospital 5/21/03 with severe epigastric pain, which was intermittent for several weeks. Given IV fluids and pain medications. During hospital stay patient had a MRI and ERCP performed. Hospital Course: The patient is a 68 year old white female with a significant past medical history for COPD and status post cholecystectomy who arrived from her primary care physician's office with abnormal pancreatic enzyme on the day of admission. She had been having severe epigastric pain off and on for the previous several weeks. The patient had been previously treated with nexium for this epigastric pain, however the pain continued effectively ruling out GERD. On the day of admission the pain was noted to be 10:10 in intensity. It worsened after a fatty meal. The patient had denied any nausea, vomiting, changes in stools, no melena, no blood per rectum, and no changes in skin color. However, she did have this worsening epigastric pain and some peritoneal signs. The patient was admitted on the evening of the 21st, was evaluated by myself on the morning of the 22nd. She was noted to have nausea, but no vomiting. No chest pain or shortness of breath. No diarrhea or constipation. Labs revealed a picture consistent with acute pancreatitis. The patient was made n.p.o treated with IV fluids, electrolytes were monitored and she was given pain management with morphine. Her triglyceride level was checked, which was normal. She was unable to be assessed by ultrasound on admission secondary to her obesity. CT was unable to be performed secondary to her severe contrast allergy. She received a MRI and ERCP. On the 22nd in the afternoon the patient underwent an ERCP performed by the doctor. THe procedure was performed without complication or difficulty. Multiple sweeps of iliac duct were performed finding a dilatation of the duct and distal duct debris. The patient was treated with prophylactic antibiotic of Zosyn prior to the procedure. The patient was changed to clear liquids in the evening of the 23rd. Her enzymes drifed down. Continually, the patient did not have a white count, was afebrile and tolerated her PO intake well. On the morning of the 25th the patient was reporting a completely resolved picture with only mild epigastric tenderness to deep palpitation. She had no more pain episode and felt to be in better health at this time. Review of her labs on the 24th showed continued drift downwards in all of the pancreatic enzymes. The patient was afebrile without a white count. Physical exam was noted only for a very mild tenderness in her epigastrium. She was tolerating her diet well and is to be discharged home on a low-fat diet. In discussion with the doctor and myself, the patient is in agreement with her discharge. This was discussed with doctor covering for doctor.