Overview of the Clinical Consult Case Review of Adverse Events Following Immunization: Clinical Immunization Safety Assessment Network (CISA) 2004-2009

Details

• Alternative Title:
  Vaccine
• Personal Author:
  Williams, S Elizabeth ; Klein, Nicola P ; Halsey, Neal ; Dekker, Cornelia L ; Baxter, Roger P ; Marchant, Colin D ; LaRussa, Philip S ; Sparks, Robert C ; Tokars, Jerome I ; Pahud, Barbara A ; Aukes, Laurie ; Jakob, Kathleen ; Coronel, Silvia ; Choi, Howard ; Slade, Barbara A ; Edwards, Kathryn M
• Description:
  Background
  
  In 2004 the Clinical Consult Case Review (CCCR) working group was formed within the CDC-funded Clinical immunization Safety Assessment (CISA) Network to review individual cases of adverse events following immunizations (AEFI).
  
  Methods
  
  Cases were referred by practitioners, health departments, or CDC employees. Vaccine Adverse Event Reporting System (VAERS) searches and literature reviews for similar cases were performed prior to review. After CCCR discussion, AEFI were assessed for a causal relationship with vaccination and recommendations regarding future immunizations were relayed back to the referring physicians. In 2010, surveys were sent to referring physicians to determine the utility and effectiveness of the CCCR service.
  
  Results
  
  CISA investigators reviewed 76 cases during 68 conference calls between April 2004 and December 2009. Almost half of cases (35/76) were neurological in nature. Similar AEFI for the specific vaccines received were discovered for 63 cases through VAERS searches and for 38 cases through PubMed searches. Causality assessment using the modified WHO criteria resulted in classifying 3 cases as definitely related to vaccine administration, 12 as probably related, 16 as possibly related, 18 as unlikely related, 10 as unrelated, and 17 had insufficient information to assign causality. The physician satisfaction survey was returned by 30 (57.7%) of those surveyed and a majority of respondents (93.3%) felt that the CCCR service was useful.
  
  Conclusions
  
  The CCCR provides advice about AEFI to practitioners, assigns potential causality, and contributes to an improved understanding of adverse health events following immunizations.
  
  
• Subjects:
  Adverse Adverse Drug Reaction Reporting Systems Article Case-Control Studies Causality Data Collection Event Following Humans Immunization Referral And Consultation Vaccines

  More +
• Source:
  Vaccine. 29(40):6920-6927
• Pubmed ID:
  21801776
• Pubmed Central ID:
  PMC5832019
• Document Type:
  Journal Article
• Funding:
  CC999999/Intramural CDC HHS/United States
• Volume:
  29
• Issue:
  40
• Collection(s):
  CDC Public Access
• Main Document Checksum:
  urn:sha256:f5da5ce330828695fcc2570aedac0c5b4639e2ac5d447df681ef6b243a93e4c2
• Download URL:
  https://stacks.cdc.gov/view/cdc/52160/cdc_52160_DS1.pdf
• File Type:
  [PDF - 110.98 KB ]