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Life Threatening? No
Write-up: sudden death; weakness on the 2nd day after the vaccination; Injection site pain; Fatigue; Nausea; malaise; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB DE-PEI-CADR2021061549, Safety Report Unique Identifier DE-PEI-202100053957. A 74-year-old female patient received BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 28Apr2021 10:30 (at age of 74 years old) as single dose for COVID-19 immunisation. Medical history included Parkinson''s disease NOS from 2011, ongoing Schizo-affective type of psychosis. The patient''s concomitant medications were not reported. On 30Apr2021 the patient experienced sudden death. 28Apr2021, malaise. On 29Apr2021 the patient experienced Injection site pain, Fatigue, Nausea. On 30Apr2021, weakness on the 2nd day after the vaccination. An autopsy was not performed. The outcome was the not recovered/not resolved for Injection site pain, fatigue, Nausea. The outcome of the non-fatal event was not recovered. Senders comments: Information on risk factors or previous illnesses Schizo-affective psychosis for about 40 years; Parkinson''s diagnosis since 2011/malaise on the evening of the vaccination (28Apr2021; 10.30h vaccination appointment) and the days after, pain in the whole left arm on the day after the vaccination, fatigue; sudden death on the 2nd night after vaccination. The Pharmacovigilance Center assessed the causal relationship between bnt162b2 (COMIRNATY) and all the reported events as D. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: sudden death
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