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Life Threatening? Yes
Write-up: This regulatory authority case was reported by a physician and describes the occurrence of COVID-19 PNEUMONIA (oboustrann? covid-19 pneumonie) in a 96-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Skin malignant melanoma excision (on the back) and Cholecystectomy. Concurrent medical conditions included Parkinson''s syndrome, Benign prostatic hyperplasia, Large intestine carcinoma since 2019, Arterial hypertension (for 30 years), Type II diabetes mellitus (for 30 years) and Ischemic heart disease (for 30 years). On 02-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 02-Apr-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced INFLUENZA LIKE ILLNESS. On 15-Apr-2021, the patient experienced COVID-19 PNEUMONIA (seriousness criteria death, hospitalization, medically significant and life threatening). On an unknown date, the patient experienced PYREXIA. The patient died on 21-Apr-2021. The reported cause of death was COVID-19 pneumonia. An autopsy was not performed. At the time of death, INFLUENZA LIKE ILLNESS and PYREXIA outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Apr-2021, SARS-CoV-2 test: positive Positive. In April 2021, Blood pressure measurement: normal normal. In April 2021, Heart rate: normal normal. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. The action taken with mRNA-1273 in response to the event was not applicable. Treatment for the events were not provided. No Concomitant medications were provided Company comment: The event of COVID 19 PNEUMONIA is assessed as unlikely related to mRNA-1273 while based on the current available information and temporal association between the use of the product and the start date of the other events, a causal relationship cannot be excluded. This case was linked to CZ-CZSUKL-21004569 (E2B Linked Report).; Sender''s Comments: The event of COVID 19 PNEUMONIA is assessed as unlikely related to mRNA-1273 while based on the current available information and temporal association between the use of the product and the start date of the other events, a causal relationship cannot be excluded. CZ-CZSUKL-21004569:; Reported Cause(s) of Death: COVID-19 pneumonia
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