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Life Threatening? No
Write-up: Dizziness; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number PL-URPL-3-473-2021. A male patient of an unspecified age received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in Arm Left on 25Mar2021 11:50 (Batch/Lot Number: ET3674) as 0.3 mL, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 28Mar2021 20:30, the Emergency Medical Team was called due to dizziness. On arrival, the patient deteriorated, resuscitation was started and a doctor was called to declare death. The patient died on 28Mar2021. It was not reported if an autopsy was performed. Sender Comment: Comirnaty- COVID-19 vaccine (mRNA). Dizziness is an unexpected adverse reaction for this vaccine. It is not possible to address the cause of death without knowing the patient''s medical history. Regulatory Authority has requested supplementary information. There is a temporal relationship between vaccination and the occurrence of adverse reactions and death. The reporter classified the ADR as severe. Regulatory Authority assessed the ADR as severe. Relatedness of drug to reaction(s)/event Source of assessment Method of assessment WHO scale Result of Assessment Conditional No follow-up attempts possible. No further information expected; Reported Cause(s) of Death: dizziness
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