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Causality

Assessing individual reports of adverse events following immunizations (AEFI) can be challenging. Most published reviews are based on expert opinions, but the methods and logic used to arrive at these opinions are neither well described nor understood by many health care providers and scientists.

The Clinical Immunization Safety Assessment (CISA) network developed a standardized algorithm to help health care providers assess the causal relationship between individual adverse events and vaccines.

We hope that this algorithm approach can assist with educational efforts to improve the collection of key information on AEFI and provide a platform for teaching about causality assessment.

  • Publication: Halsey NA, Edwards KM, Dekker CL, Klein NP, Baxter R, Larussa P, Marchant C, Slade B, Vellozzi C; Causality Working Group of the Clinical Immunization Safety Assessment network. Algorithm to assess causality after individual adverse events following immunizations. Vaccine 2012 Aug 24;30(39):5791-8.   PubMed abstract | article (may require password)
  • Algorithm: link to the algorithm from the above publication.
  • Causality Tool - This tool is intended as a teaching tool and is not designed to to replace a physician's independent judgement regarding patient care.
  • Sample Cases: Illustrations of how various adverse events progress through the online Algorithm
    • Hypersensitivity: 20 year-old female developed hives 1 hour after influenza vaccine (no other exposures)
    • Febrile Seizures
      • Case 1:  12 month-old with AEFI 9 days after MMR vaccination
      • Case 2:  12 month-old with AEFI 4 days after MMR vaccination
    • ADEM (Acute Disseminated Encephalomyelitis): 13 year-old male developed acute neurologic disorder 12 days after meningococcal vaccine; diagnosed as ADEM following MRI (no other exposures)
  • CISA - Clinical Immunization Safety Assessment Project - a national network of vaccine safety experts from the CDCís Immunization Safety Office (ISO), seven medical research centers, and other partners, which provides a comprehensive vaccine safety public health service to the nation.
 

 

This page was last updated on June 09, 2016

© 2016 Institute for Vaccine Safety