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Write-up: Pneumonia with empyema / effusion; atrial flutter; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB. The Regulatory authority report number is NO-NOMAADVRE-FHI-2021-U4m2x and safety unique identifier NO-NOMAADVRE-E2B_00014998. An 88-year-old male patient received bnt162b2 (COMIRNATY; Lot number EJ6795), intramuscular from 14Jan2021, at 13:46 at single dose for covid-19 immunization. Medical history included aortic aneurysm from an unknown date, leg amputation on an unknown date, due to ischemia, frailty from an unknown date (frailty score 7), atherosclerotic cardiovascular disease from an unknown date, wheelchair user from an unknown date, memory impairment from an unknown date, smoker from an unknown date, pneumonia from 12Jan2021 with empyema/effusion, living in a nursing home from an unknown date, chronic obstructive pulmonary disease from an unknown date. Concomitant medication included amoxicillin (MANUFACTURER UNKNOWN), for lung infection from 12Jan2021. The patient previously took influenza vaccine for immunization. The patient experienced pneumonia with empyema / effusion in Jan2021 (reported as on 12Jan2021), which was serious as involved hospitalization and lead to death. On 17Jan2021, atrial flutter was noted, with unknown outcome. The patient underwent lab tests and procedures which included chest x-ray: showed a thickening compatible with pneumonia on 15Jan2021, c-reactive protein: 82 on 12Jan2021, heart rate: 150-200 on 15Jan2021. Therapeutic measures were taken as a result of pneumonia with empyema / effusion. Details were as follows: early morning on 12Jan2021, the patient was short of breath. This was assessed to be a lung infection and oral treatment with amoxicillin was started. On 14Jan2021, the patient felt better, the staff observed easier breathing than the day before. He was afebrile, a little tired, but considered to be improving with no signs of short life expectancy. Vaccinated the same day. Early in the morning on 15Jan2021, the patient experienced worsening and was admitted to the hospital where it was assessed that the patient had severe pneumonia with empyema/effusion. It was noted that changed antibiotics several times but not responded. On 26Jan2021, the patient died. Reporter does not interpret the course as a reaction from the vaccine, but as a pneumonia with gradually a storming course. No known allergies were noted. The patient had been vaccinated against influenza earlier on an unspecified date. The patient cared for himself, had a good mood and ate as normal and did not have shortness of breath or pain in the week before the event. Early morning on 12Jan2021, he was short of breath, had a good effect of Atrovent and Ventoline at 06:00, CRP at 82 5 hours later. Suspected lung infection and started treatment with amoxicillin immediately. Patient was still up in the chair and observed effortless respiration. In the evening pain, in the left upper abdomen/flank which was relieved by adjusting the bed rest. On the day 13Jan2021, noted soreness in the left abdominal region again as well as coughing, but effortless breathing. Interpreted as constipation or rib pain from coughing. He still cared for himself, ate a little less, but drank well. On 14Jan2021, he felt better, the staff observed easier breathing than the day before. He was afebrile, a little slack but considered to be improving with no signs of short life expectancy. Vaccinated the same day at 13:46. Self-help in self-care in the evening. On 15Jan2021 (04:30 am), noted increased pain in the upper left part of the abdomen, wheezing, cold and clammy, low blood pressure and low oxygen saturation. Patient was admitted to the hospital, observed productive cough, obstructive pulmonary physics, heart rate between 150 and 200, pleural fluid with 3 cm brake, possibly organized with septa. Assessed as severe pneumonia with empyema/effusion. Given Cefotaxim and Flagyl. Got thoracic drain with regression of fluid retention and improved breathing. Chest X-ray after this showed a thickening compatible with pneumonia. On 17Jan2021, atrial flutter was 200, attempted conversion. Relieved with midazolam and morphine on pain pump and oxygen until he died 26Jan2021. The doctor''s assessment noted that the patient was vaccinated due to COPD, smoking and widespread cardiovascular disease, frailty grade 7, regardless of help with personal care but in need of a nursing home due to reduced cognition. He had been physically stable and considered not to have a high risk of dying for the next 6 months. He was somewhat more improved from infection on the day of vaccination, but perceived as having an infection with a mild course. The flank/abdominal pain in the left side from 12Jan2021 is subsequently interpreted as a lung infection near the cleft palate with the development of slough in the cleft palate with increased pain, low blood pressure and failing lung function. Heart failure due to rapid heart rate may also have contributed to fluid in the lung cleft. Reporter did not interpret the course as a reaction from the vaccine, but a pneumonia with an eventually storming course. The patient died on 26Jan2021. It was not reported if an autopsy was performed. Sender Comment: An 88 year old man was vaccinated with Comirnaty 14Jan2021. The patient is multimorbid with COPD, atherosclerotic disease, previous aortic aneurysm, amputated leg due to ischemia and impaired memory. The patient lived in a nursing home, used a wheelchair and smoked. Early in the morning 12Jan2021 the patient was short of breath which was believed to be a lung infection and treatment with amoxicillin was started immediately. On 14Jan2021 the patient felt better and the staff observed lighter breathing than the day before. The patient was afebrile, a little fatigued but considered to be improving with no signs of short life expectancy. The vaccine was given the same day. Early in the morning of 15Jan2021, the patient experienced deterioration and was admitted to hospital. The patient''s condition was assessed as severe pneumonia with empyema / effusion. The antibiotic was changed several times without the patient responding. 26Jan2021 the patient died. Reporter does not interpret the course as a reaction from the vaccine, but a pneumonia which turned into a rapidly deteriorating state. When vaccinating patients with frailty who are ill with many underlying diseases, some serious events, including death, may occur briefly time after vaccination without any connection to vaccination. However, it cannot be ruled out that the vaccine has contributed to the worsening of the patient''s underlying disease. In each case, it is difficult to know whether the death is due to the vaccine, the patient''s underlying disease or other incidental cause. On the basis of the information in the notification and in accordance with international criteria, the causal relationship with vaccination is considered as possible, but which may also be due to underlying disease, other drugs or chemicals. Since the patient died, the message is classified as serious, even though no causal link between the vaccine and the death has been established. The death cause was noted as unknown. Relatedness of drug to reactions was reported as unlikely; Source of assessment Regional Pharmacovigilance Center: Possible No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: unknown cause of death
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