Age: 90.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Dehydration, Depressed level of consciousness, Dysphagia, Dyspnoea, General physical health deterioration
Clinical narrative: Initial unsolicited report received from a Consumer (patient's spouse) on 11-Apr-2018. This case involves a 90-year-old male patient who was vaccinated with a 0.5 mL dose of FLUZONE HIGH-DOSE (batch number: U1845AA, expiry date: 13-APR-2018) intramuscularly in left arm at 14:48 PM and 0.5 mL dose of PREVENAR 13 (injection suspension, batch number: R56671, expiry date: 30-APR-2018) intramuscularly in right arm, both on 17-Oct-2017 at 14:50 PM. His baseline vital signs and condition was good. The patient's medical history included back pain, essential tremors, neurogenerative gait disorder, enlarged prostate and incontinence. Concomitant medications included Carbidopa-Levodopa 25-100 mg (90 tablets) since 2014, one tablet three times a day, FLOMAX 0.4 mg, one capsule twice a day since Feb-2017, Finasteride 5 mg, one tablet per day since Apr-2017, Temazepam 15 mg (1-2 capsules at bedtime) since 2003 and TYLENOL for headache and back pain occasionally. On 07-Nov-2017, 21 days post vaccination; the patient was very sick, feverish, gurgling and pale, had rapid, shallow breathing, phlegmy cough, sinus tachycardia, dehydration and was semi-conscious. The patient was given oxygen (BIPAP), respiratory therapy and antibiotics and saline intravenously. His weight as reported by the hospital was approximately 101 lbs (approx. 45 kg). On 11-Nov-2017 at 08:00 AM, 25 days post vaccination, symptoms got worse with a cough and difficulty in breathing. The patient remained in the Emergency Room until 11 pm, at which time he was admitted to the hospital in serious condition on the same day. Chest X-ray showed bilateral pneumonia and the patient was diagnosed with full-blown pneumonia. On 11-Nov-2017, 25 days post-vaccination, the patient was diagnosed with sepsis, acute respiratory failure with hypoxia, dysphagia, lactic acidosis, hyponatremia and eventually acute kidney failure. Both his arms were hooked up to multiple IVs and he had oxygen tubes in his nostrils. From 12-Nov-2017 to 16-Nov-2017, post vaccination, the patient had symptoms of extreme pain, labored breathing, and coughing with a lot of mucus. The IVs remained administering antibiotics, oxygen, etc. He was not eating. At the same time, he was being administered breathing treatments through a face mask. The staff was checking him constantly. At one point, the tapes holding the IVs in place in his arms came off and he started bleeding. Two nurses came in and secured the IVs and put on his hands something that looked like boxing gloves. On unknown date, post vaccination, the patient was agonizing and started to lose his ability to communicate and to keep his one eye open. He continued to receive strong doses of antibiotics and respiratory therapy to clear the mucus. He was diagnosed with pneumonia but compounding the condition was his ET/Parkinson's disease. The doctor and the nurses said that the very debilitating symptoms of Parkinson's were making his condition worse. The patient's condition continued to deteriorate. Other lab investigations were not reported. On 16-Nov-2017, Morphine was added to help with the pain in breathing and the abdominal pain from Parkinson's. The patient was removed from the antibiotic treatment and the other medications and was placed in Hospice care in the hospice wing of the hospital while keeping him on Morphine, Oxygen, ATIVAN and ROBINUL to alleviate agitation and the pain he had breathing, coughing and in the general area of the  abdomen. On 17-Nov-2017, the patient was unconscious and was exhibiting irregular breathing. The nurse said he had apnea. On 18-Nov-2017, the patient was resting quietly in bed in his Hospice room when he stopped breathing and passed away at 03:11 PM. Two nurses came in and confirmed that he had died. Cause of death was reported as Pneumonia. It was not reported if the autopsy was performed or not. At the time of death, the outcome of the events sepsis, acute respiratory failure with hypoxia, dysphagia, lactic acidosis, hyponatremia, acute kidney failure, extreme pain, speech loss and pain in general area of the abdomen was not reported. This case was also considered as serious by the reporter due to life threatening events. It was reported that the patient's family was not given any information prior to the injection of either vaccine and they believe that pneumonia vaccine in particular caused the patient to develop full-blown pneumonia, after 3 and a half weeks, which was the cause of his death (hospital records). In sum, thirty-two days after receiving the administration of FLUZONE HIGH-DOSE and PREVENAR 13, without the physician informing the patient that he had ordered the administration of the Pneumonia Vaccine and the Flu Vaccine before leaving the examination room, nor giving him any information (possibly an Information Form about the vaccines), the patient died. List of documents held by sender: none. Sender's Comments: This elderly patient developed pneumonia, abdominal pain, acute kidney failure, lactic acidosis, hypoxia, sepsis, hyponatremia, other pneumonia related symptoms including tachycardia, apnea, dyspnea and died a month after receiving vaccination with FLUZONE HIGH-DOSE and PREVNAR 13 (other manufacturer). Time to onset was compatible. Past medical history included essential tremors, neurogenerative gait disorder (Parkinson's disease), enlarged prostate and incontinence. Reported cause of death was pneumonia. Additional information including results of autopsy report, response to previous dose of FLUZONE (received if any) is needed for further assessment of the case. Moreover the patient received two vaccines concomitantly, hence role of assessment of individual component is not possible. Reported Cause(s) of Death: full-blown pneumonia.