Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Death, Dementia, Oxygen saturation decreased, Pulse absent, Pyrexia
Clinical narrative: From initial information received on 10/Nov/2004 from the FDA (VAERS # 228347) regarding an adverse event, it was reported that a 79-year-old female patient received a FLUZONE SV '2004-'2005 USP vaccination, lot number U1478AA, administered intra-muscularly in the left arm on 14/Oct/2004. The next day, 15/Oct/2004, the patient experienced a temporary episode of respiratory distress. Three days later, on 18/Oct/2004, the patient developed a fever of 100.5 degrees Fahrenheit, five days later, on 23/Oct/2004, the patient had a fever of 100.5 degrees Fahrenheit and was given oxygen by nasal cannula but was responsive, the fever broke late morning. Oxygen saturations were between 87 and 92%. Later that same day the patient again developed a fever of 102.4 degrees Fahrenheit and developed rapid breathing while on oxygen. Per the nurses' notes the durable power of attorney was called that day and the nurses were instructed that the decision was for no antibiotics be administered to the patient and to maintain the comfort of the patient. The patient was found in her bed without a pulse, blood pressure or respiration at 9:00 PM that evening. The reporter of this case is the same reporter of cases 2004-03646, 2004-03647 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 end-stage dementia. 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 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 public and healthcare provider confidence in vaccines. A 78 year old patient (previously reported as 79 years old) with a history of skin cancer, unexplained weight loss (nine pounds) from September to October 2004. Four days post vaccination the patient developed an intermittent fever. Eleven days post vaccination the patient died. According to the death certificate, cause of death was end stage dementia. No additional information was provided. The following case was also associated with the literature article 2009-03219.