COVID-19

Priority List of Adverse events of special interest for

COVID-19

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: Thrombosis / Thromboembolism Specific to COVID-19 disease: ✅ Brighton Case Definition: Click to access Brighton CD Companion Guide: Click to access
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

1 Some seasonal influenza vaccines; monovalent H1N1 pandemic vaccine; COVID-19 ChAdOx-1 S vaccine.
2 AESI added to COVID-19 list in October 2022 based on signals declared by regulatory agencies with requirements for manufacturers to update product information.

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:

SEE ALL THE LISTS OF AESIs FOR THE CEPI PRIORITIZED PATHOGENS:

SEE ALL THE LISTS OF AESIs FOR THE CEPI PRIORITIZED PATHOGENS:

COVID-19
Chikungunya
Lassa Fever
Rift Valley Fever