* Likely due to direct viral infection and relevant mostly to live-attenuated vaccines.
† Recommend applying FDA 2007 Toxicity Grading Scales: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/toxicity-grading-scale-healthy-adult-and-adolescent-volunteers-enrolled-preventive-vaccine-clinical#:~:text=Toxicity%20Grading%20Scale%20for%20Healthy%20Adult%20and%20Adolescent
§ Late sequela of MVD with evidence of viral persistence in tissue.
¶ Hemorrhagic disease should have clinical evidence of spontaneous bleeding

** Evidence of spontaneous bleeding would suggest hemorrhagic disease. Evidence of spontaneous bleeding includes ≥ 1 of: bruising, purpura, epistaxis, petechiae, hematuria, hematemesis, hematoma, hematochezia, persistent bleeding from venipuncture sites, hemorrhagic oozing of skin lesion, conjunctival bleeding, vaginal bleeding (unless menstruating), occult bleeding from rectum, intracranial bleeding. These are included in the CD for thrombocytopenia; and the Companion Guide for thrombocytopenia has a glossary of terms relevant to spontaneous bleeding.
†† Organ involvement may present individually; severe infection would result in multisystem involvement.
§§ Theoretical concern about enhanced disease due to binding Abs to MARV antigens.
¶¶ One case report (Johannesburg ex Zimbabwe: Gear JSS, BMJ 1975 ); and evidence in Ebola virus disease.

*** 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
¶¶¶ Age-based risk for children aged ≤ 5 y.

**** BC tools exist for Generalized convulsive seizure and Fever.  


Cite the Marburg AESI list:

Brighton Collaboration SPEAC Project. (2024). Priority List of Adverse Events of Special Interest (AESI) for Marburg Virus Disease Vaccines (V1.1). Zenodo. https://doi.org/10.5281/zenodo.13890053 (PDF of AESI list can be downloaded from Zenodo).