11/5/08 Death Summary received from FDA.  Pt had been admitted 5/2/08 with severe pancreatitis-epigastric abdominal pain and N&V. Tachycardic on admission. PE (+) for abd tenderness and lower extremity edema. Pt became hypoxic eventually requiring intubation and acute renal failure. Pt also developed Atrial Fibrillation and anemia requiring 4 units of PRBCs. Family consented to comfort care and pt was extubated 5/15/07 and expired. Dx at TOD: Severe pancreatitis with probable necrotizing pancreatitis of unclear etiology.  Septic shock due to gram (-) rod bacteremia, Acute renal failure on hemodialysis, Respiratory Failure, DM, HTN, Hyperlipidemia, hx of chronic back pain, hx of osteopenia. Labs and Diagnostics: BUN 28. Creatinene 1.2. WBCs 24K. CT scan abd (+) for pancreatitis, possibly hemorrhagic. Stools guaiac (+)./Information has been received from an agency concerning a 70 year old female with diabetes mellitus, hypertension, hyperlipidaemia, chronic back pain and osteopenia who on 17-APR-2007 was vaccinated with ZOSTAVAX (Oka/Merck) (lot # 656861/0329U).  This report was part of a study.  Concomitant therapy included Td vaccine.  The patient presented to the emergency room with complaint of abdominal pain on the evening prior to admission, occurring 30-45 minutes after dinner.  In the emergency room, she was afebrile with a blood pressure or 142/51, heart rate 88 and respiratory rate 19.  Her abdominal exam was significant for some moderate tenderness to palpation in the epigastric region as well as the right lower quadrant region.  She had trace lower extremity edema.  Her initial labs showed normal liver function tests and normal urinalysis.  Her chemistry panel was remarkable for BUN 28 and elevated creatinine of 1.2 from her prior baseline.  White blood count was 24,000.  A CT scan of the abdomen at the time of admission showed pancreatitis, possibly hemorrhagic with an enlarged pancreatic head and peripancreatic right anterior pararenal space and right paracolic gutter effusions of high density were also noted.  On 02-MAY-2007, She was admitted to the medical surgical floor with the diagnosis of pancreatitis.  The patient was kept NPO for severe pancreatitis; however, in the morning, her electrolytes showed her bicarbonate decrease from initial 23 to 16 with an anion gap of 22, BUN was elevated at 33 and her creatinine was 1.3.  White blood cell count initially had been 24,000 and was 20,000.  STAT lactate level was obtained, which was 4, and patient's status was subsequently changed from medical/surgical to intensive care unit.  She was treated with empiric imipenem.  Her calcium level was noted to be low, and she subsequently was repleted.  On 03-MAY-2007, patient became increasingly hypoxic and was subsequently intubated, developing respiratory failure.  She required LEVOPHED for blood pressure support.  Chest x-rays revealed significant pleural effusions, most likely from the aggressive IV fluid hydration.  She was intubated as indicated above and ventilation was managed by the intensivist.  Patient developed acute renal failure, which was most likely due to ATN.  Patient's creatinine on May 2nd was 1.3 when it had previously been 1.  After some aggressive IV fluid hydration the following day on May 3rd it was 0.8.  However, it continued to increase, most likely due to hypoperfusion to the kidneys, as she did become hypotensive and required LEVOPHED.  Nephrology was consulted on May 3rd, and the nephrologist continue to follow.  She was started on hemodialysis after failing a LASIX trial and hemodialysis continued.  On 05-MAY-2007 the patient was noted to have an episode of atrial fibrillation.  She was started on an AMIDARON drip and converted back into sinus rhythm where she remained during her hospital course.  The patient was placed on intensive insulin drip for diabetes mellitus, which was titrated off, and for the rest of her course was on a sliding scale insulin with close monitoring of her blood sugars.  The patient developed hypocalcemia which was due to severe pancreatitis.  This was monitored closely and repleted.  As of 15-MAY-2007, the pancreatitis appeared to be significantly worse overnight.  She had required increased LEVOPHED support and her lactate on the morning of 15-MAY-2007 increased to 9.4.  The patient was also requiring increased ventilator support with 15 of PEEP, which had increased overnight, as well as the fact that she remained in atrial fibrillation at a heart rate of 130s despite being on an AMIODARONE drip.  After conversation with the intensivist, who had been following the patient, it was decided to have a family meeting regarding the patient's poor prognosis, and it was decided at that time to focus on comfort care.  Pressor support was withdrawn, the patient was extubated, and she expired shortly after on 15-MAY-2007.  The cause of death was reported as sepsis and pancreatitis.  A lot check has been requested.  This is one of several reports from the same source.  Additional information has been requested.  11/5/08 Death Summary received from FDA.  Pt had been admitted 5/2/08 with severe pancreatitis-epigastric abdominal pain and N&V. Tachycardic on admission. PE (+) for abd tenderness and lower extremity edema. Pt became hypoxic eventually requiring intubation and acute renal failure. Pt also developed Atrial Fibrillation and anemia requiring 4 units of PRBCs. Family consented to comfort care and pt was extubated 5/15/07 and expired. Dx at TOD: Severe pancreatitis with probable necrotizing pancreatitis of unclear etiology.  Septic shock due to gram (-) rod bacteremia, Acute renal failure on hemodialysis, Respiratory Failure, DM, HTN, Hyperlipidemia,  1/9/09-COD-Necrotizing pancreatitis, etiology unknonw.