Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Bacterial infection, Drug ineffective, Ear pain, Hypotension, Laboratory test abnormal
Clinical narrative: Information has been received from a physician concerning a 60 year old male with history of lymphoma (in remission since 1996), pneumococcal septicemia (2001 "treated successfully") and asplenia who in 1998 and on 11/4/03 was vaccinated with a first and second dose of pneumococcal 23v polysaccharide vaccine (645249/1196M), respectively. Concomitant therapy included clonidine, amlodipine besylate and irbesartan for high blood pressure. Other therapy included fexofenadine hydrochloride and fluticasone propionate for allergies. It was noted that the pt was initially vaccinated with pneumococcal 23v polysaccharide vaccine due to the lymphoma and asplenia. It was also reported that the pt was in routine follow-up with oncologist who "recommended a pneumococcal 23v polysaccharide vaccine this year." The reporting physician reported that the patient was seen on 11/4/03 and was asymptomatic. On 11/6/03 the patient presented to the emergency room of the hospital with symptoms of high fever, and pain in one ear. There was a questionable otitis or sinusitis. The oncologist reported that his findings were not that impressive. On 11/7/03 the patient was admitted to the hospital by the oncologist. There were reported to be "four blood cultures positive for pneumococcus" also reported as "positive culture for strep pneumonia." The patient later became hypotensive, went into shock, and was sent to the intensive care unit. The physician reported that the patient was intubated and that the pulmonary physician that had resumed care for the patient reported that there was a lot of stuff in the patient's lungs while intubating him. The patient had a chest x-ray resulted as possible pneumonia. On 11/8/03 the pt died. The cause of death was not provided. There was no product quality complaint involved. Additional info has been requested. Follow up: The reporting physician reported that the patient was seen on 04NOV2003 and was asymptomatic. On 06NOV2003 the patient presented to the emergency room of the hospital with symptoms of high fever, and pain in one ear. There was a questionable otitis or sinusitis. The oncologist reported that his finding were "not that impressive." On 07NOV2003 the patient was admitted to the hospital by the oncologist. There were reported to be "four blood cultures positive for pneumococcus" also reported as "positive culture for strep pneumonia." The patinet later became hypotensive, went into shock, and was sent to the intensive care unit. The physician reported that the patient was intubated and that the pulmonary physician that had resumed care for the patient reported that there was a lot of "stuff" in the patient's lungs while intubating him. The patient had a chest xray resulted as possible pneumonia. On 09NOV2003 the patient died. The cause of death was not provided. It was reported to be unknown if serotyping was done. The physician reported that he knew an autopsy was not done. It was noted that the reporter expressed a concern for the lot. The records of testing prior to release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released. Additional information has been requested.