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Priority List of Adverse Events of Special Interest for
MPOX
This list of potential Adverse Events of Special Interest (AESI) that could follow vaccines to prevent Mpox was developed based on criteria established by the Safety Platform for Emergency Vaccines (SPEAC), which include:
- A known association with immunization or a specific vaccine platform.
- The occurrence during wild-type disease due to viral replication and/or immunopathogenesis.
- A theoretical association derived from animal models.
Special populations, including pregnant women, children, adolescents, and immunosuppressed individuals, may experience an increased frequency and severity of any of the AESIs listed as relevant to all populations. There are also specific AESI that are of particular relevance to special populations, and these are listed according to the population. It is important to note that children, pregnant women and immunocompromised individuals may also have increased severity of expected local and systemic reactogenicity, as well as unexpected autoimmune conditions.
This list is based on the available data for mpox vaccines, which are to be used in response to the 2024 Public Health Emergency of International Concern (PHEIC) for mpox in Africa.
View the list below, and download it from our Zenodo site.
AESI: Myocarditis / Pericarditis
Specific to Chikungunya disease: 
Brighton Case Definition: Click to access
Brighton CD Companion Guide: Click to access
AESI: Thrombosis / Thromboembolism
Specific to Chikungunya disease:
Brighton Case Definition: Click to access
Brighton CD Companion Guide: Click to access
AESI: Hemorrhagic disease
Specific to Chikungunya disease:
Brighton Case Definition: End of 2023
Brighton CD Companion Guide: End of 2023
AESI: Thrombocytopenic Thrombosis Syndrome ²
Specific to vaccine: Adeno vectors
Brighton Case Definition: End of 2023
Brighton CD Companion Guide: End of 2023
AESI: Anaphylaxis
Specific to vaccine: All
vaccines
Brighton Case Definition: Click to access
Brighton CD Companion Guide: Click to access
AESI: Thrombocytopenia
Specific to Chikungunya disease:
Specific to vaccine: All
vaccines
Brighton Case Definition: Click to access
Brighton CD Companion Guide: Click to access
AESI: Acute aseptic arthritis
Specific to vaccine: VSV vector
Brighton Case Definition: Click to access
Brighton CD Companion Guide: Dec 2023
AESI: Acute/chronic Inflammatory Rheumatism
Specific to Chikungunya disease:
Brighton Case Definition:Prioritized, date TBD
Brighton CD Companion Guide:Prioritized, date TBD
AESI: Generalized convulsion
Specific to Chikungunya disease:
Specific to vaccine: All
vaccines
Brighton Case Definition: Click to access
Brighton CD Companion Guide: Click to access
AESI: Aseptic meningitis
Specific to Chikungunya 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 Chikungunya disease:
Brighton Case Definition: Click to access
Brighton CD Companion Guide: Click to access
AESI: Encephalitis
Specific to Chikungunya 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 Chikungunya disease:
Specific to vaccine: Live attenuated viral vaccine
Brighton Case Definition: Click to access
Brighton CD Companion Guide: Click to access
AESI: Guillain Barré Syndrome
Specific to Chikungunya 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 Chikungunya disease:
Brighton Case Definition: Click to access
Brighton CD Companion Guide: Click to access
AESI: Uveitis/Retinitis/Optic neuritis
Specific to Chikungunya disease:
Brighton Case Definition:Prioritized, date TBD
Brighton CD Companion Guide:Prioritized, date TBD
AESI: Alopecia
Specific to Chikungunya disease:
Brighton Case Definition: TBD
Brighton CD Companion Guide: TBD
AESI: Spontaneous abortion
Specific to Chikungunya disease:
Brighton Case Definition: Click to access
Brighton CD Companion Guide: Mid 2023
AESI: Stillbirth
Specific to Chikungunya disease:
Brighton Case Definition: Click to access
Brighton CD Companion Guide: Aug 2023
AESI: Maternal death
Specific to Chikungunya disease:
Brighton Case Definition: Click to access
Brighton CD Companion Guide: Aug 2023
AESI: Neonatal sepsis
Specific to Chikungunya disease:
Brighton Case Definition: Click to access
Brighton CD Companion Guide: TBD
AESI: Neonatal encephalopathy
Specific to Chikungunya disease:
Brighton Case Definition: Click to access
Brighton CD Companion Guide: TBD
AESI: Neurodevelopmental delay
Specific to Chikungunya disease:
Brighton Case Definition: Click to access
Brighton CD Companion Guide: TBD
Priority List of Adverse events of special interest for
Mpox
§ BC tools do not exist for all the AESIs listed for special populations. However, there are other tools (e.g. toxicity grading scales) that may be applied.
¶ BC tools exist for Generalized convulsive seizure and Fever.
**Guidelines for data collection exists as part of the GAIA project: https://brightoncollaboration.org/global-alignment-of-immunization-safety-assessment-in-pregnancy-gaia/
†† The Stillbirth CD publication update is pending.
§§ BC CD for hypertensive disorder of pregnancy
¶¶ BC CD exists for Neonatal infection.
*** Including malnutrition
††† Viral infection or live-attenuated viral vaccination can worsen immunosuppressive states.
References:
1. https://www.hosp.ncgm.go.jp/isc/vaccines/MNK/Vaccination_Procedure_Guideline_for_Lc16.pdf
2. Ladhani SN, Dowell AC, Jones S, et al. Early evaluation of the safety, reactogenicity, and immune response after a single dose of modified vaccinia Ankara-Bavaria Nordic vaccine against mpox in children: a national outbreak response. Lancet Infect Dis. 2023 Sep;23(9):1042-1050. doi: 10.1016/S1473-3099(23)00270-0. Epub 2023 Jun 16. PMID: 37336224.
Cite the mpox AESI list:
Brighton Collaboration SPEAC Project. (2024). Mpox CEM template protocol. APPENDIX 1: Mpox Adverse Events of Special Interest (AESIs) (1.0). Zenodo. https://doi.org/10.5281/zenodo.13785131 (PDF of AESI list can be downloaded from Zenodo).
