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

Body System​

AESI

Specific to COVID-19 disease

Specific to
vaccine platform

Brighton Case Definition

Brighton CD Companion Guide

CardiacMyocarditis / Pericarditis☑️mRNA, Novavax

Click to access

Click to access

EndocrineAcute pancreatitis TBDTBD
Subacute thyroiditis TBDTBD
HematologicThrombosis / Thromboembolism 

Click to access

Click to access

Hemorrhagic disease End of 2023End of 2023

Thrombocytopenic Thrombosis Syndrome ²

Adeno vectorsEnd of 2023End of 2023
Capillary Leak Syndrome (flare-ups) ²Adeno vectors (EMA)End of 2023End of 2023
ImmunologicAnaphylaxis
All
vaccines

Click to access

Click to access

Thrombocytopenia
All vaccines

Click to access

Click to access

Immune Thrombocytopenia ²Adeno vectors (EMA,TGA,FDA)TBDTBD
Vaccine-Associated Enhanced Disease 

Click to access

Click to access

Multisystem Inflammatory Syndrome, Children / Adults 

Click to access

Click to access

Single Organ Cutaneous VasculitisAd26 (FDA)

Click to access

June 2023
Erythema multiforme TBDTBD
Delayed hypersensitivity²Spikevax (MHRA)TBDTBD
Facial swelling in persons with dermal fillers²mRNA (EMA, MHRA)TBDTBD
MusculoskeletalAcute aseptic arthritisVSV vector

Click to access

End of 2023
Rhabdomyolysis TBDTBD
NeurologicGeneralized convulsionAll vaccines

Click to access

Click to access

Aseptic meningitisLive attenuated viral vaccine​

Click to access

Click to access

Acute Disseminated Encephalomyelitis 

Click to access

Click to access

Anosmia 

Click to access

TBD
Encephalitis
Live attenuated viral vaccine​

Click to access

Click to access

MyelitisLive attenuated viral vaccine​

Click to access

Guillain Barré Syndrome

Some vaccines¹

Click to access

Click to access

Bell’s Palsy 

Click to access

Click to access

Dizziness and tinnitus²Ad26 (EMA)TBDTBD
RespiratoryAcute Respiratory Distress Syndrome 

Click to access

Click to access
Injected limbExtensive limb swelling²Comirnaty
(MHRA)
TBDTBD
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