Age: 90.0
Sex: M
Vaccine: FLU4, PNC13, FLU3, PNC13, FLU3, PNC13
Symptoms: Haemorrhage, Hyponatraemia, Hypophagia, Hypopnoea, Hypoxia
Clinical narrative: Initial unsolicited report received from consumer (patient's wife) via patient's daughter through other company Pfizer (MFR control number: 2017509222) on 13-Dec-2017. This case involves a 90-year-old male patient, who was vaccinated with 0.5ml single dose of both FLUZONE HIGH DOSE injection via intramuscular route (Lot number: UI845AA; expiration date: 13-Apr-2019) and PREVNAR 13 (Lot number: R56671; expiration date: 30-Apr-2018; dose in series not reported for both the vaccines) both at unspecified arm (reported as right or left arm) on 17-Oct-2017 around 14:15 or 14:30. Medical history included flu started on an unspecified date of 2016. Concurrent condition included enlarged prostate on Jan-2017, essential tremors of Parkinson's disease (reported as started about three years ago or maybe before then) and parkinson's like symptoms on unspecified date of Jan-2017. Concomitant medications included Carbidopa/Levodopa at a dose of one dosage form thrice daily orally from 09-Apr-2015 for parkinson's disease, Flomax at a dose of 0.4mg once daily orally from February-2017 and Finasteride tablet at a dose of 5mg once daily orally from 26-Apr-2017 for enlarged prostate and Temazepam capsule at a dose of 15 mg once daily from an unknown date (reported as long time ago) for help him sleep. It was reported that patient was previously vaccinated without any adverse event. The patient did not receive any other vaccinations within 4 weeks of vaccinations. On 11-Nov-2017, 25 days following the vaccination, the patient had experienced fever, difficulty breathing and had gotten sick. The patient was taken to emergency room via an ambulance at 11:00 on the same day because of the events and was admitted to hospital on 11-Nov-2017. Later that day of 11-Nov-2017, the patient was diagnosed with pneumonia. Laboratory investigations included on 11-Nov-2017, Chest X-Ray showed pneumonia, blood test showed pneumonia bacteria in the blood stream. Septic. Corrective treatments included Zosyn, Vancomycin and Morphine, unspecified anticoagulants, anti-platelet and antiemetic medications. It was also reported that after the doctor told them that the staff could not do anything else for him and the patient near the end of his life. On 16-Nov-2017, patient was transferred to hospital and given Morphine. Again this was given as part of his treatment for the end of life. Outcome of the events fever, difficulty breathing and sick were unknown. On 18-Nov-2017 the patient passed away due to the event pneumonia. It was reported that autopsy was not performed. List of documents held by sender: none. Sender's Comments: Pneumonia of unknown etiology was confirmed as the cause of death. The patient was also vaccinated with FLUZONE HIGH DOSE and PREVENAR 13 vaccines. Pneumonia is an infection of the lung which may be caused by bacteria, viruses, fungi or parasite. However, Microbiological examinations did not reveal an etiological factor of infection. Considering the nature of the adverse events reported and the available information, it is unlikely that the reported events are due to the vaccination. Considering patient's age, concurrent conditions and vaccination with multiple products it would be difficult to assess the causality with respect to one vaccine. Reported Cause(s) of Death: Pneumonia.