Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Urine analysis abnormal, Urine colour abnormal
Clinical narrative: From initial information received on 10/Nov/2004 from the FDA (VAERS # 228345-1), it was reported that an 80-year-old male patient received a FLUZONE SV '2004-'2005 USP vaccination, lot number U1478AA, on 14/Oct/2004. Order written for 1cc Flu vaccine; documented administration same, though facility says patient actually received 0.5cc. Four days later, on 18/Oct/2004, dark, cloudy urine was noted. A urinalysis was ordered and urine was collected on 20/Oct/2004. The results were not available until 24/Oct/2004 which showed numerous proteus mirabilis, sensitivities were also noted. No orders for antibiotics were noted in the patient's records. On 22/Oct/2004 at 2:10 pm the patient was found in the bathroom unresponsive and pale with no pulse, no respiration and no blood pressure. CPR was initiated but was unsuccessful. According to the patient's medical records the only recent acute medical problem revealed was a urinary tract infection. Per the director of the nursing facility an autopsy was not done on the patient. The reporter of this case is the same reporter of cases 2004-03647, 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 hypertension and cerebral vascular accident. No other information was provided. Additional information concerning this patient was received 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 death 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 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 (IRR) = 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  important to ensure vaccine safety and to maintain pubic and healthcare provider confidence in vaccines. An 80 year old patient with a medical history of a colon cancer, arthritis, hypertension, obstructive sleep apnea, hypokalemia, diverticulosis and obesity. The patient developed cloudy urine four days post vaccination. Eight days post vaccination the patient died. According to the death certificate, cause of death was hypertension and CVA. No additional information was provided. The following case was also associated with this literature article 2009-03219.