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|History of Changes from the VAERS Wayback Machine|
|Vaccination / Manufacturer||Lot / Dose||Site / Route|
|COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH||EY2172 / 1||- / OT|
Administered by: Other Purchased by: ??
Symptoms: Acute pulmonary oedema, Body temperature, Cardiac failure, Death, Loss of consciousness, Pyrexia, SARS-CoV-2 test
Life Threatening? No
Birth Defect? No
Permanent Disability? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? Yes
Hospitalized? Yes, days:
Write-up: suspension of consciousness; Heart failure; Fever; Acute pulmonary edema; Death; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB RO-NMA-2021-SPCOV11177. A 60-years-old male patient received the first dose of BNT162B2 (COMIRNATY, lot number: EY2172 and expiration date not provided), via intramuscular, on 13May2021, at single dose, for COVID-19 immunization. Medical history included heart failure in treatment with three stents for acute events. Concomitant medication included sacubitril valsartan sodium hydrate (ENTRESTO) taken for cardiac failure from 15Jul2020. The patient experienced heart failure (death, hospitalization) on 14May2021, fever (death, hospitalization) on 14May2021, acute pulmonary edema (death, hospitalization) on 14May2021, death (death) on 29May2021. On 14May2021, the patient developed fever, heart failure, acute pulmonary edema and death. The physician comments were: According to the family, 24 hours after the vaccination, patient had fever that gave way to antipyretics initially, but the fever reappeared intermittently for 4 days. On 17May2021 (reported as "the fourth day"), the patient presented an episode of suspension of consciousness, which was why he was referred to the emergency room. In the reporter''s opinion the events were related to Comirnaty. The adverse reaction was assessed as "results in death" by the primary reporter. The patient underwent lab tests and procedures which included body temperature was increased (as fever adverse event reported) on 14May2021; Sars-Cov-2 test was negative on 14May2021. Therapeutic measures were taken as a result of event fever. The outcome of the events was fatal. The patient died on 29May2021 (also reported as "the night of 28-29May 2021"). It was not reported if an autopsy was performed. Sender''s comments: The Agency requested the investigation of the case at the Regulatory Authority, to no result yet. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Unknown; Heart failure; Fever; Acute pulmonary edema; suspension of consciousness
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