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Life Threatening? No
Write-up: Internal haemorrhage; Blood pressure decreased; This is a spontaneous report from a contactable consumer or other non hcp downloaded from a regulatory authority-WEB PL-URPL-DML-MLP.4401.2.317.2021. An 81-year-old female patient received BNT162b2 (COMIRNATY, Lot number unknown) via an unspecified route of administration on 18Mar2021 at single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. On 20Mar2021, the patient experienced a severe internal bleeding and pressure drop. On 21Mar2021 the patient died. Cause of death: internal hemorrhage, but both events were fatal. An autopsy was performed. Result: death. Autopsy results were not available. The reporting person marked the severity criterion: death. A regulatory authority classified the application as serious. Sender''s comment: Bleeding is an unexpected side effect of Comirnaty. Comirnaty is currently investigated for an association with immune thrombocytopenia, which can cause bleeding, but massive internal bleeding (and associated pressure drop) as the only sign of thrombocytopenia is unlikely. There is a time relationship between the administration of the vaccine and the occurrence of side effects. The reporting person marked the severity criterion: death. A regulatory authority classified the application as serious. Comirnaty. Relatedness of drug to reaction(s)/event(s): Blood pressure decreased, Internal hemmorhage: Source of assessment: (unlisted) Method of assessment: (unlisted), Result of Assessment: Unlikely. Information about lot/batch number cannot be obtained. No further information expected.; Reported Cause(s) of Death: Blood pressure decreased; Internal haemorrhage
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