Priority List of Adverse events of special interest for
Lassa Fever
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AESI: Pericarditis
Specific to LF disease:
Brighton Case Definition: Click to access
Brighton CD Companion Guide: Click to access
AESI: Myocarditis
Specific to vaccine: MVA¹
Brighton Case Definition: Click to access
Brighton CD Companion Guide: Click to access
AESI: Polyserositis / Face & Neck Swelling
Specific to LF disease:
Brighton Case Definition: TBD
Brighton CD Companion Guide: TBD
AESI: Thrombosis with Thrombocytopenia Syndrome (TTS)
Specific to vaccine: Adenovirus vector
Brighton Case Definition: End of 2023
Brighton CD Companion Guide: End of 2023
AESI: Hemorrhagic disease (bleeding from mucosa / skin)
Specific to LF disease:
Brighton Case Definition: TBD
Brighton CD Companion Guide:TBD
AESI: Vascular leakage (edema, polyserositis)
Specific to LF disease:
Brighton Case Definition: TBD
Brighton CD Companion Guide:TBD
AESI: Thrombocytopenia
Specific to vaccines: All vaccines
Brighton Case Definition: Click to access
Brighton CD Companion Guide: Click to access
AESI: Anaphylaxis
Specific to LF disease:
Specific to vaccine: All
vaccines
Brighton Case Definition: Click to access
Brighton CD Companion Guide: Click to access
AESI: Single Organ Cutaneous Vasculitis
Specific to vaccine: r-VSV
Brighton Case Definition: Click to access
Brighton CD Companion Guide: Dec 23
AESI: Severe Lassa Fever infection (ARDS; AKI with KDIGO ≥2; NEWS2≥7; LFTs≥3X upper limit of normal; shock; multiorgan failure; death)
Specific to LF disease:
Brighton Case Definition: TBD
Brighton CD Companion Guide: TBD
AESI: Acute aseptic arthritis
Specific to vaccine: VSV vector
Brighton Case Definition: Click to access
Brighton CD Companion Guide: End of 2023
AESI: Aseptic meningitis
Specific to LF disease:
Specific to vaccine: Live attenuated viral vaccine
Brighton Case Definition: Click to access
Brighton CD Companion Guide: Click to access
AESI: Encephalitis
Specific to LF 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 LF disease:
Specific to vaccine: Live attenuated viral vaccine
Brighton Case Definition: Click to access
Brighton CD Companion Guide: Click to access
AESI: Generalized convulsion
Specific to vaccine: All
vaccines
Brighton Case Definition: Click to access
Brighton CD Companion Guide: Click to access
AESI: Guillain Barré Syndrome
Specific to vaccine: Some vaccines¹
Brighton Case Definition: Click to access
Brighton CD Companion Guide: Click to access
AESI: Sensorial Hearing Loss
Specific to LF disease:
Brighton Case Definition: Click to access
Brighton CD Companion Guide: Click to access
AESI: Acute Kidney Injury
Specific to LF disease:
Brighton Case Definition: TBD
Brighton CD Companion Guide:TBD
AESI: Acute Respiratory Distress Syndrome (ARDS)
Specific to LF disease:
Brighton Case Definition: Click to access
Brighton CD Companion Guide: Click to access
AESI: Alopecia
Specific to LF disease:
Brighton Case Definition: TBD
Brighton CD Companion Guide: TBD
AESI: Single Organ Cutaneous Vasculitis
Specific to vaccines: VSV Vector
Brighton Case Definition: Click to access
Brighton CD Companion Guide: Mid 2023
The AESI of relevance to maternal immunization studies and to Lassa fever vaccine studies have outlined in a dedicated guidance document, accessible HERE.
1 Some seasonal influenza vaccines; monovalent H1N1 pandemic vaccine; COVID-19 ChAdOx-1 S vaccine.
The list above is the most updated version of AESI for Lassa Fever. The complete version including the methods and literature evaluation will be available soon.
See the previous completed version HERE.