Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Death, Pyrexia
Clinical narrative: Initial report was received 30 September 2010 from a health care professional, who received the report from the patient's wife. A 74-year-old male patient who had a history of asthma and allergies to weeds and molds, had received a first dose injection of FLUZONE HIGH-DOSE (lot number, route and site of administration unknown at the time of the report) and an unspecified allergy shot on 21 September 2010. On 24 September 2010, three days post vaccination, the patient developed a slight fever which resolved the following day. According to the reporter, the patient went to bed on 26 September 2010 and the following day on 27 September 2010, six days post vaccination, the patient was found dead in bed. The patient had no concurrent illness at the time of vaccination. The patient had been taking EFFEXOR, FLOMAX, "NEUROTIN", Hydromorphone and "guiafesen". Concomitantly. The patient had also received allergy shots in the past. At the time of the report, it was unknown if an autopsy had been performed. No additional information was provided at the time of the report. Follow-up information received from a health care professional on 18 October 2010. It was reported that the patient had no illnesses at the time of vaccination. No information was provided regarding the lot number of FLUZONE HIGH-DOSE and no cause of death was reported. Follow-up information received from a health care professional on 13 December 2010. A copy of the physician office visit for 21 September 2010 was provided. At the time of vaccination on 21 September 2010 the patient's family history included a sister who was 56 years of age and in good health. Social history for the patient included light mental and physical work, and light exercise with no risk factors. Physical examination that day revealed the patient's vital signs as follows: height 6.2 feet, weighed 241.5 pounds, BSA 2.364, BMI 30.67, temperature 97.7 degrees Fahrenheit (auricular), blood pressure 126/80 (sitting), and pulse 99 beats/minute (taken in left upper extremity). Examination of the lymphatic system revealed right cervical node lymphadenopathy that was painful and tender. The nasal mucosa revealed hyperemia with purulent discharge. The subject had generalized wheezes with decreased air exchange and scattered rhonchi that cleared on coughing. Diagnosis was active allergic rhinitis due to pollen, otherwise healthy. The subject was administered 0.5mL of FLUZONE HIGH-DOSE (lot number U3601AA, expiration date 05 May 2011) in the right arm. He also received one allergy injection (the reporter's office used code "professional service, supervisor preparation provision, antigens, allergen Immunotherapy: single/multiple antigens). Follow-up information received from a health care professional via telephone call. A copy of the autopsy report and additional patient history was requested, however the reporter stated it was unknown if the autopsy had been performed. They usually receive a copy of the death certificated, but had not received one to date. The reporter did not know what allergy shot the patient had received on 21 September 2010, but stated the patient had a history of allergies to trees, weeds and cats. The patient had been seen in the reporter's office due to allergies and sinus congestion, and the reporter stated the patient had taken Guaifenesin for bronchitis and asthma, and prednisone and ADVAIR for allergies. Per the reporter, the patient had not been seen at their facility following the event of slight fever that occurred 3 days post vaccination, and the reporter had no additional information pertaining to that event. The reporter was asked to provided contact information for any other physicians the patient may have seen, but the reporter had no information. Follow-up information was received from a health care professional on 14 February 2011. The reporter stated they do not have a copy of the patient's death certificate and do not receive copies of death certificates or autopsy reports. She did provide a contact where a copy of the report and certificate could be obtained. No further information was provided at the time of the report. Documents held by sender: Copy of physician office visit on 21 September 2010.