Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Body temperature increased, Chronic obstructive pulmonary disease, Condition aggravated, Cough, Death
Clinical narrative: From initial information received on 10/Nov/2004 from the FDA (VAERS # 2283438) regarding an adverse event, it was reported that a 70-year-old male patient received FLUZONE SV '2004-'2005 USP vaccination, lot number U1478AA, administered on 14/Oct/2004. Prior to the patient's flu immunization the patient exhibited a cough on 20/Sep/2004 and on 07/Oct/2004 he began choking and coughing with food. Six days post vaccination, on 20/Oct/2004, the patient's cough became worse and he had developed lung congestion. His blood oxygen was 80-85%, oxygen was 26. The following day, on 21/Oct/2004, the patient's vital signs were temperature 97.4 degrees Fahrenheit, blood pressure 150/80 and blood oxygen was 92% with oxygen. On 21/Oct/2004 hospice care was ordered. On 22/Oct/2004 the patient's vital signs were temperature 99 degrees Fahrenheit, blood pressure 130/70 and oxygen saturation was 90% with three liters of oxygen. At 11am that day the patient was unresponsive. At 5:35am on 23/Oct/2004 the patient expired. According to the nursing director of the nursing facility where the patient expired, an autopsy was not performed on the patient. From the medical records it was reported that the patient experienced under hospice care which had been initiated a few days prior to his death. Lab results were included in the records for a CBC drawn on 24/Oct/2004. The WBC's were 12.2 and the HCT was 40.9. On the day prior to the patient's death his temperature was 101 degrees Fahrenheit. There were no new orders noted for antibiotic therapy. On 22/Oct/2004, the day prior to the patient's death he was started on morphine and ROXANOL. At 5:30am on 23/Oct/2004, no blood pressure, no pulse or respirations were detected. The reporter of this case is the same reporter of cases 2004-03646, 2004-03647 and 2004-03648. All four cases came from the same Long Term Care facility. From additional information received on 16/Nov/2004 from an internal e-mail communication from a VAERS nurse researcher, it was reported that the death certificate was received. The cause of death was listed as end-stage dementia and COPD. No other information was provided. Additional information concerning this patient was identified on 27 July 2009 from a literature citation. Purpose: To evaluate a possible association between influenza vaccination and four deaths and four serious illnesses among 114 recent influenza vaccinees in a long-term care facility (LTCF) and two deaths from a nearby physician's office. All had received vaccine from the same lot (Lot A). Methods Field investigation including (1) a retrospective cohort study among LTCF residents who received Lot A or other influenza vaccine, (2) review of medical records of cases of death or serious illness, (3) active surveillance of deaths among 1500 community based Lot A vaccinees and (4) laboratory testing of vaccine from available Lot A vials. Results Medical record reviews showed no common clinical syndrome or cause of death. Laboratory testing of Lot A samples revealed no evidence of tampering and no differences