Table 2.

Special attentions concerning COVID-19 vaccines security pharmacovigilance (data at the 03/25/2021).

Vaccine and exposition	Number of ADR reports	ADRs under monitoring, according to SOCs	Potential or confirmed signals
Cominarty® BioNTech-Pfizer-m-RNA 1st dose: 4,807,987 2nd dose: 2,443,424	12,249	–Nervous system disorders: convulsions, facial paralysis, anosmia, ageusia –Infections: COVID-19 infections –Cardiac disorders: pericarditis, –Immune system disorders: hypersensitivity/anaphylaxis and asthma –Ear and labyrinth disorders: hearing disorders, vestibular disorders –Vascular disorders: aortic dissection, vasculitis	–Arterial hypertension –Cardiac arrhythmias –Herpes zoster infection –Thrombocytopenia/spontaneous hematomas –Diabetes imbalances
COVID-19 vaccine Moderna®-m-RNA 1st dose: 616,626 2nd dose: 173,223	577	–Vascular disorders: arterial hypertension –Cardiac disorders: cardiac arrhythmias –Infections: herpes zoster infection –General disorders and administration site conditions: reactogenicity	–Local delayed reactions
COVID-19 vaccine AstraZeneca®-Non-replicating viral vector 1st dose: 1,923,580	7439	–Vascular disorders: hypertension, hypotension, epistaxis –Cardiac disorders: myopericarditis/pericarditis, rhythm and conduction disorders –Respiratory, thoracic and mediastinal disorders: exacerbations of dyspnea and asthma –Nervous system disorder: non-infectious encephalitis –Immune system disorders: anaphylactic reactions –General disorders and administration site conditions: hypothermia –Blood and lymphatic system disorders: lymphopenia –Metabolism and nutrition disorders: diabetes imbalances	–Influenza-like symptoms –Large venous thrombosis (cerebral, digestive), with thrombocytopenia or coagulation disorders

ADR: adverse drug reaction; COVID: coronavirus disease; SOC: system organ class.