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Life Threatening? No
Write-up: Death; Malaise; Vomiting; This is a spontaneous report received from a contactable physician from the Regulatory Agency (RA). The Regulatory Authority report number is GB-MHRA-WEBCOVID-20210105172532, Safety Report Unique Identifier GB-MHRA-ADR 24558660. An 81-year-old female patient received bnt162b2 (BNT162B2) (lot# EJ1688), via an unspecified route of administration, on 30Dec2020, at single dose, for COVID-19 immunisation. Medical history included vascular dementia (advanced dementia), dementia Alzheimer''s type (vascular and Alzheimer''s mixed dementia), oral intake reduced (patient known to not be eating or drinking), fluid intake reduced, (patient known to not be eating or drinking), general physical health deterioration (patient known to be declining); all from an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient experienced death on 03Jan2021, malaise on 01Jan2021 with fatal outcome, vomiting on 01Jan2021 with fatal outcome. It was reported that 48 hours after vaccination the patient became unwell, vomited and then died on 03Jan2021. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on 27Dec2020. Patient has been not tested positive for COVID-19 since having the vaccine. It was not reported if an autopsy was performed. It was not known whether vaccine caused reaction. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Malaise; Vomiting; Death
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