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Life Threatening? No
Write-up: heart failure; Death; feeling sick; changes with speech and mobility; changes with speech and mobility; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-20210111094207, Safety Report Unique Identifier: GB-MHRA-ADR 24577774. A 97-year-old female patient received the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EJ1688), via an unspecified route of administration on 08Jan2021 at a single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 10Jan2021, the patient experienced feeling sick (medically significant), changes with speech and mobility (speech disorder) (medically significant). On 11Jan2021, the patient experienced death (death, medically significant). On an unspecified date, the patient experienced heart failure (death, medically significant). The clinical course was reported as follows: "The resident had got heart failure." The patient was feeling sick on 10Jan2021 and was concerned as there were changes with speech and mobility. Emergency was called, and the ambulance arrived. It was stated the sats were low and blood pressure was low. The ambulance crew called for an out of hours general practitioner (GP) to come and see the patient. The out of hours general practitioner (GP) visited on 10Jan2021 and advised "she maybe poorly due to having the Covid-19 vaccine" that was administered on the 08Jan2021. The resident passed away at 07:20 on morning 11Jan2021. The patient had not tested positive for COVID-19 since having the vaccine. The patient had not had symptoms associated with COVID-19. The patient was not enrolled in a clinical trial. The patient underwent lab tests and procedures which included COVID-19 virus test: no-negative COVID-19 test on an unspecified date, oxygen saturation (sats): low on 10Jan2021, blood pressure: low on 10Jan2021. The clinical outcome of the event, death and heart failure, was fatal. The clinical outcome of the event, feeling sick and changes with speech and mobility, was unknown. The patient died on 11Jan2021 due to heart failure. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: heart failure
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