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An event is serious (based on the ICH definition) when the patient outcome is:
* death
* life-threatening
* hospitalisation
* disability
* congenital anomaly
* other medically important event
An 86-year-old man developed acute coronary tree thrombosis following immunisation with covid-19-vaccine-pfizer-biontech.
The man, who had a history of paroxysmal atrial fibrillation treated with apixaban and prostate cancer required prostatectomy, radiotherapy and enzalutamide, received the first dose of covid-19-vaccine-pfizer-biontech [Pfizer–BioNTech vaccine; route and dosage not stated] on 27 January 2021. Approximately 30 minutes after the injection, he collapsed and his electrocardiogram findings were consistent with elevation in acute ST-segment myocardial infarction of the inferior wall. Thus, he was admitted to the hospital and was unconscious with signs of recurrent bradyarrhythmias and cardiogenic shock. His coronary angiography demonstrated occlusions/distal embolisation in the left-sided anterior descending coronary artery and in the distal region of the dominant right-sided coronary artery along with thrombus. The man underwent percutaneous coronary intervention, manual aspiration thrombectomy along with balloon angioplasty and eptifibatide therapy that led to improvement in coronary flow. His control coronary artery angiogram showed no evidence of previous thrombus. Thus, it was considered that acute coronary tree thrombosis was secondary to covid-19-vaccine-pfizer-biontech vaccine. However, he died on 30 January 2021 [cause of death not stated].
Reference
- Tajstra M, et al. Acute Coronary Tree Thrombosis After Vaccination for COVID-19. JACC: Cardiovascular Interventions 14: e103-e104, No. 9, 10 May 2021. Available from: URL: 10.1016/j.jcin.2021.03.003 [DOI] [PMC free article] [PubMed]