Age: 61.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Cough, Cyanosis, Diarrhoea, Endocarditis, Hyperhidrosis
Clinical narrative: Information has been received from a health professional and a physician concerning a 61 year old male with a history of coronary bypass surgery who on 9/30/03 was vaccinated with a dose of penumococcal 23v polysaccharide vaccine (645246/0029N). Concomitant therapy included influenza virus vaccine and Coumadin. For several days after the vaccine the pt had a fever and chills. On 10/8/03 the pt was brought to the ER with chills, sweats and a fever. The report indicated that they "did tests." It was also reported that he had a chest x-ray and CBC and was given an injection of Rocephin and Phenergan. He was diagnosed with mild renal failure. He was discharged with a prescription for Keflex and went home. The next day, on 10/9/03, the pt died of pneumonia. The reporter expressed a concern with the lot. There was no product quality complaint involved. Pneumonia was considered to be immediately life-threatening and disabling. Additional info has been requested.  The autopsy report states septic endocarditis. Follow up on 12/04/03: "The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory.  The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Follow up information from a physician and medical records indicated that the pt had open heart surgery on 23Dec2002 which consisted of one by-pass and a valve replacement. It was reported that the operation went well and the pt had a remarkable recovery. He first had a heart murmur which felt to be benign. He followed up with his primary who ordered an echodardiogram and the problem with his heart valve was discovered. He was sent for a cardiac cathaterization and they recommended immediate replacement of his aortic valve together with a repair of the aneurysm. On 30Sep2003 the pt was seen by a physician and reported to be in good health, and would probably live to be 100. His physical exam was negative at that time. That day he received te pneumococcal 23v polysaccharide vaccine and the influenza virus vaccine. On 02Oct2003 the pt had his monthly labwork done for a a warfarin sodium level. The result was 3.3 and he was instructed to stay on the same dose. On 04Oct2003 the pt was feeling a bit under a the weather, was coughing and did not act up to par. On 05Oct2003 the pt felt the same way, but he had a slight cough and was hoarse. By 07Oct2003 the pt began to run a temperature of 103 and was having uncontrollable chills, sweating, vomiting and diarrhea. The symptoms were only temporary and he took acetaminophen which broke the fever. He had a good appetite and was eating three meals a day. On 08Oct2003 the pt felt good, but had a bout with uncontrollable chills and reported that he was so cold he couldn't get warm. He took two acetaminophen and felt better, but later had the sweating, vomiting and diarrhea.  At 8:30PM he was again having uncontrollable chills and the lobes of his ears looked blue. He was not running a temperature. He was seen in the ER and was told he had symptoms of pneumonia. His temperature was normal and his blood pressure was a little low. He was told by a physician that this was because he was sick. A chest x-ray and bloodwork were done and were reported to be normal, however his blood sugar was 184. He was told that this may make him a little confused. His wife reported that he was confused after taking it. It was reported that the doctor also ordered an injection of something for nausea and an injection of an antibiotic. The pt's wife was assured by the nurse that these medications would not interact with anything the pt was currently taking. He was given IV to replace body fluids since his blood presure was low. While he was on the IV he had to go to the bathroom with diarrhea and vomiting. It was reported that he was very weak and almost fell off the commode. The pt was released from the ER with a diagnosis of a viral infection and was given prescriptions for dicyclomin hydrochloride 10mg capsule, cephalexia 500mg capsule and diphen/atrop 2.5mg tablet. It was reported that he rested well that night, but did a lot of night sweating. He felt better than the day before, but was still experiencing diarrhea and vomiting. ON 09Oct03 at 7:37AM the pt's blood pressure was 91-56-117 and his temperature was 96. He tried to eat and drink and his blood pressure at 8:25 was up to 101-54-112. The pt indicated that he would be ok so his wife left the house. She found him at 10:30AM sitting on the floor. He had gotten up to go to the bathroom, but felt sick so he sat there to vomit in the trash can. His wife put him in bed, he took his medications and drank some water and reported that his throat burned. At 10:41AM his blood pressure was 80-44-68 and his nails were blue so the pt's wife called 911. The pt reported that his neck hurt, so his wife removed pillows and the pt turned his head and stopped breathing. The wife started CPR. With no reponse after a few minutes, she ran out and screamed to a neighbor. The neighbors gave CPR until the ambulence arrived. The pt was taken to the ER where the family was told the pt passed away. An autopsy was performed and the cause of death was listed as septic paravalvular leak due to dehiscence of prosthetic aortic valve due to prosthetic valve endocarditis with ring abscess. The death was reported as natural.  Pneumonia, sepsis, endocarditis, abscess and leakage were considered to be immediately life-threatening and disabling.  Additional information is not expected."