Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Diet refusal, Dry skin, Fatigue, Haemoglobin decreased, International normalised ratio increased
Clinical narrative: From initial information received on 10/Nov/2004 from the FDA (reference number 228346-1) regarding an adverse event occurring, it was reported that a 76-year-old male patient received 1cc of FLUZONE SV '2004-'2005 USP vaccine, lot number U1478AA, administered on 14/Oct/2004. Two days later on 16/Oct/2004 the patient's vital signs were as follows: blood pressure 140-50, temperature 96.6 degrees Fahrenheit, the patient complained of feeling tired. At 1:00pm that same day the patient refused his lunch as his stomach was upset, his skin was white, dry and pale. At 2:25pm that afternoon while the patient was being assisted to bathroom in his wheelchair he slumped over and had no vital signs. Per the director of the nursing home an autopsy was not performed on the patient. The most recent medical records included a discharge summary for an inpatient stay from 06/Sep/2004 to 09/Sep/2004 at a local hospital. The diagnosis on discharge was bilateral lower extremity cellulitis, possible bacteremia, DM type two, hyperlipidemia, depression, coronary artery disease, atrial fibrillation, congestive heart failure, lymphedema, chronic renal insufficiency, venous stasis ulcers and gout. The reporter of this case is the same reporter of cases 2004-03646, 2004-03648 and 2004-03649. 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 coronary artery disease and congestive heart failure. 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 vaccines 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. A samples revealed no evidence of tampering and no differences compared to an unrelated lot. The risk of death or hospitalization was not significantly different between persons who received Lot A versus a comparison lot, Lot B (incidence rate ratio (NRR) = 0.9, 95%CI = 0.3-3.3). Conclusions There was no clinical or biological evidence pointing to inherent vaccine safety issues, nor was there a detectable increased risk of death or hospitalization among persons vaccinated with Lot A. Lot specific clustering of adverse events (AEs) may reflect medical events causally unrelated to vaccination. Rapid investigations of potential AEs are most important to ensure vaccine safety and to maintain public and healthcare provider confidence in vaccines. A 75 year old patient had a history of diabetes mellitus, hypercholesterolemia, anemia, depression, coronary artery disease, atrial fibrillation, congestive heart failure, lymphedema, chronic renal insufficiency, and gout. The patient began coughing and became lethargic one day prior to vaccination. Two days post vaccination the patient died. According to the death certificate, the cause of death was CAD and CHF. No additional information was provided. The following case was also associated with the literature article 2009-03219.