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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
In a randomized cross-sectional retrospective study including 1012 patients, conducted in April 2021, two patients were described, a patient [age and sex not stated] developed allergic reaction following AZD-1222 and one female patient [age not stated] developed immune thrombotic thrombocytopenia following immunization with AZD-1222 [dose and route not stated].
The patient received AZD-1222 [AstraZeneca] vaccine for COVID-19. Subsequently, 5-15 minutes after receiving the vaccine, the patient developed allergic reaction [outcome not stated].
The female patient received AZD-1222 [AstraZeneca] vaccine for COVID-19. She developed elevation in D-dimer levels secondary to AZD-1222 administration. She developed vaccine-induced immune thrombotic thrombocytopenia (VITT). Furthermore, she developed thromboembolism and was hospitalised for further unspecified treatment [outcome not stated].
Reference
- Almufty HB, et al. Potential adverse effects of COVID19 vaccines among Iraqi population; a comparison between the three available vaccines in Iraq; a retrospective cross-sectional study. Diabetes and Metabolic Syndrome: Clinical Research and Reviews 15: 102207, No. 5, Sep 2021. Available from: URL: 10.1016/j.dsx.2021.102207 [DOI] [PMC free article] [PubMed]