Priority List of Adverse events of special interest for
COVID-19
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AESI: Myocarditis / Pericarditis
Specific to COVID-19 disease:
Specific to vaccine: mRNA, Novavax
Brighton Case Definition: Click to access
Brighton CD Companion Guide: Click to access
AESI: Acute pancreatitis
Specific to COVID-19 disease:
Brighton Case Definition: TBD
Brighton CD Companion Guide: TBD
AESI: Subacute thyroiditis
Specific to COVID-19 disease:
Brighton Case Definition: TBD
Brighton CD Companion Guide: TBD
AESI: Hemorrhagic disease Specific to COVID-19 disease: Brighton Case Definition: End of 2023 Brighton CD Companion Guide: End of 2023
AESI: Thrombocytopenic Thrombosis Syndrome ² Specific to COVID-19 disease: – Specific to vaccine: Adeno vectors Brighton Case Definition: End of 2023 Brighton CD Companion Guide: End of 2023
AESI: Capillary Leak Syndrome (flare-ups) ² Specific to COVID-19 disease: – Specific to vaccine: Adeno vectors (EMA) Brighton Case Definition: End of 2023 Brighton CD Companion Guide: End of 2023
AESI: Anaphylaxis
Specific to COVID-19 disease: –
Specific to vaccine: All
vaccines
Brighton Case Definition: Click to access
Brighton CD Companion Guide: Click to access
AESI: Thrombocytopenia
Specific to COVID-19 disease: –
Specific to vaccine: All
vaccines
Brighton Case Definition: Click to access
Brighton CD Companion Guide: Click to access
AESI: Immune Thrombocytopenia ²
Specific to COVID-19 disease: –
Specific to vaccine: Adeno vectors (EMA,TGA,FDA)
Brighton Case Definition: TBD
Brighton CD Companion Guide: TBD
AESI: Vaccine-Associated Enhanced Disease
Specific to COVID-19 disease:
Specific to vaccine: –
Brighton Case Definition: Click to access
Brighton CD Companion Guide:Click to access
AESI: Multisystem Inflammatory Syndrome, Children / Adults
Specific to COVID-19 disease:
Specific to vaccine: –
Brighton Case Definition: Click to access
Brighton CD Companion Guide:Click to access
AESI: Single Organ Cutaneous Vasculitis
Specific to COVID-19 disease:
Specific to vaccine: Ad26 (FDA)
Brighton Case Definition: Click to access
Brighton CD Companion Guide: June 2023
AESI: Erythema multiforme
Specific to COVID-19 disease:
Specific to vaccine: –
Brighton Case Definition: TBD
Brighton CD Companion Guide: TBD
AESI: Delayed hypersensitivity²
Specific to COVID-19 disease: –
Specific to vaccine: Spikevax (MHRA)
Brighton Case Definition: TBD
Brighton CD Companion Guide: TBD
AESI: Facial swelling in persons with dermal fillers²
Specific to COVID-19 disease: –
Specific to vaccine: mRNA (EMA, MHRA)
Brighton Case Definition: TBD
Brighton CD Companion Guide: TBD
AESI: Acute aseptic arthritis
Specific to COVID-19 disease: –
Specific to vaccine: VSV vector
Brighton Case Definition: Click to access
Brighton CD Companion Guide: End of 2023
AESI: Rhabdomyolysis
Specific to COVID-19 disease: –
Specific to vaccine: –
Brighton Case Definition: TBD
Brighton CD Companion Guide: TBD
AESI: Generalized convulsion
Specific to COVID-19 disease: –
Specific to vaccine: All
vaccines
Brighton Case Definition: Click to access
Brighton CD Companion Guide: Click to access
AESI: Aseptic meningitis
Specific to COVID-19 disease: –
Specific to vaccine: Live attenuated viral vaccine
Brighton Case Definition: Click to access
Brighton CD Companion Guide: Click to access
AESI: Acute Disseminated Encephalomyelitis
Specific to COVID-19 disease: –
Specific to vaccine: –
Brighton Case Definition: Click to access
Brighton CD Companion Guide: Click to access
AESI: Vaccine-Associated Enhanced Disease
Specific to COVID-19 disease:
Specific to vaccine: –
Brighton Case Definition: Click to access
Brighton CD Companion Guide:Click to access
AESI: Anosmia
Specific to COVID-19 disease: –
Specific to vaccine: –
Brighton Case Definition: Click to access
Brighton CD Companion Guide: TBD
AESI: Encephalitis
Specific to COVID-19 disease: –
Specific to vaccine: Live attenuated viral vaccine
Brighton Case Definition: Click to access
Brighton CD Companion Guide: Click to access
AESI: Myelitis
Specific to COVID-19 disease: –
Specific to vaccine: Live attenuated viral vaccine
Brighton Case Definition:
Brighton CD Companion Guide: Click to access
AESI: Guillain Barré Syndrome
Specific to COVID-19 disease:
Specific to vaccine: Some vaccines¹
Brighton Case Definition: Click to access
Brighton CD Companion Guide: Click to access
AESI: Bell’s Palsy
Specific to COVID-19 disease:
Specific to vaccine: –
Brighton Case Definition: Click to access
Brighton CD Companion Guide: Click to access
AESI: Dizziness and tinnitus²
Specific to COVID-19 disease: –
Specific to vaccine: Ad26 (EMA)
Brighton Case Definition: TBD
Brighton CD Companion Guide: TBD
AESI: Acute Respiratory Distress Syndrome
Specific to COVID-19 disease:
Specific to vaccine: –
Brighton Case Definition: Click to access
Brighton CD Companion Guide: Click to access
AESI: Extensive limb swelling²
Specific to COVID-19 disease: –
Specific to vaccine: Comirnaty
(MHRA)
Brighton Case Definition: TBD
Brighton CD Companion Guide: TBD
Body System | AESI | Specific to COVID-19 disease | Specific to | Brighton Case Definition | Brighton CD Companion Guide |
---|---|---|---|---|---|
Cardiac | Myocarditis / Pericarditis | ✅ ☑️ | mRNA, Novavax | ||
Endocrine | Acute pancreatitis | ✅ | TBD | TBD | |
Subacute thyroiditis | ✅ | TBD | TBD | ||
Hematologic | Thrombosis / Thromboembolism | ✅ | |||
Hemorrhagic disease | ✅ | End of 2023 | End of 2023 | ||
Thrombocytopenic Thrombosis Syndrome ² | Adeno vectors | End of 2023 | End of 2023 | ||
Capillary Leak Syndrome (flare-ups) ² | Adeno vectors (EMA) | End of 2023 | End of 2023 | ||
Immunologic | Anaphylaxis | All vaccines | |||
Immunologic | Thrombocytopenia | All vaccines | |||
Immunologic | Immune Thrombocytopenia ² | Adeno vectors (EMA,TGA,FDA) | TBD | TBD | |
Immunologic | Vaccine-Associated Enhanced Disease | ✅ | |||
Immunologic | Multisystem Inflammatory Syndrome, Children / Adults | ✅ | |||
Immunologic | Single Organ Cutaneous Vasculitis | ✅ | Ad26 (FDA) | June 2023 | |
Immunologic | Erythema multiforme | ✅ | TBD | TBD | |
Immunologic | Delayed hypersensitivity² | Spikevax (MHRA) | TBD | TBD | |
Immunologic | Facial swelling in persons with dermal fillers² | mRNA (EMA, MHRA) | TBD | TBD | |
Musculoskeletal | Acute aseptic arthritis | VSV vector | End of 2023 | ||
Rhabdomyolysis | TBD | TBD | |||
Neurologic | Generalized convulsion | All vaccines | |||
Neurologic | Aseptic meningitis | Live attenuated viral vaccine | |||
Neurologic | Acute Disseminated Encephalomyelitis | ||||
Neurologic | Anosmia | TBD | |||
Neurologic | Encephalitis | Live attenuated viral vaccine | |||
Neurologic | Myelitis | Live attenuated viral vaccine | |||
Neurologic | Guillain Barré Syndrome | ✅ | Some vaccines¹ | ||
Neurologic | Bell’s Palsy | ✅ | |||
Neurologic | Dizziness and tinnitus² | Ad26 (EMA) | TBD | TBD | |
Respiratory | Acute Respiratory Distress Syndrome | ✅ | Click to access | ||
Injected limb | Extensive limb swelling² | Comirnaty (MHRA) | TBD | TBD | |
Learn more about methods and results of the creation of the Priority List of potential Adverse events of special interest relevant to COVID-19 vaccine trials in the links below: