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Life Threatening? No
Write-up: Fainting; Weakness; Dyspnoea; Chest pain; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB (Regulatory authority number PL-URPL-3-200-2021). A 59 years old patient of unspecified gender received BNT162B2 (COMIRNATY; lot ER0641) on 10Feb2021 at 14:00 (at the age of 59 years old), at single dose, for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 10Feb2021 in the afternoon and on the next day the patient experienced of breath, chest pain, weakness. On 11Feb2021 he fainted in the evening hours, an ambulance was called. These events were reported with a fatal outcome. The patient died on 11Feb2021 at 19:15. It was unknown if an autopsy was done. Sender Comment: Weakness (fatigue) is an expected side effect following the administration of Comirnaty. Dyspnoea, chest pain, and feeling faint are unexpected symptoms. URPL has no information on any additional circumstances (medications used, chronic diseases) that could result in the occurrence of the described side effects. Up to 16Feb2021, the EVDAS database recorded 230 deaths, 981 dyspnoea cases, 348 chest pain cases. The temporal relationship speaks for a cause-and-effect relationship. The person reporting NOP qualified it as severe. URPL assessed the undesirable post-vaccination reaction as severe due to the assessment of the reporting person and the health result-death. No follow-up attempts are possible. No further information is expected. ; Reported Cause(s) of Death: chest pain; fainting; weakness; dysponea
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