title: Ischemic cardiac events and other adverse events following ACAM2000(®) smallpox vaccine in the Vaccine Adverse Event Reporting System.
abstract: BACKGROUND
  The Vaccine Adverse Event Reporting System (VAERS) is a passive reporting system, used for monitoring the safety of all US licensed vaccines. In March 2008, ACAM2000(®) replaced Dryvax(®) as the only licensed smallpox vaccine and is administered to all persons entering military service and certain civilian researchers. In 2011, routine data mining of VAERS identified a vaccine safety concern resulting in acute ischemic cardiac events (ICE) following ACAM2000(®).
  
  
  METHODS
  During March 1, 2008 through June 30, 2013, we reviewed all serious reports received following ACAM2000(®)and classified them by diagnostic category. We identified possible ICE cases by searching the Medical Dictionary for Regulatory Affairs (MedDRA(®)) terms for "myocardial ischaemia," "acute myocardial infarction," "myocardial infarction," and "ischaemia," and applied standardized surveillance case definitions.
  
  
  RESULTS
  VAERS received 1149 reports following ACAM2000(®) administration; 169 (14.7%) were serious (resulting in permanent disability, hospitalization or prolongation of hospitalization, life-threatening illness or death), including one death. The two most frequent diagnostic categories for serious reports were cardiovascular and other infectious conditions. The MedDRA(®) search found 31 reports of possible ICE after receipt of ACAM2000(®) vaccine. Of a total 30 possible ICE cases with demographic information, all but one was male; the age range was 20-45 years (median 32) and median interval to onset of symptoms was 12 days. On clinical review there were 16 cases of myocarditis/pericarditis and 15 ICE cases.
  
  
  CONCLUSIONS
  Our review of the data mining signal did not substantiate the concerns about ICE after ACAM2000(®). Our study also suggests that with current pre-vaccination screening, cardiac morbidity in generally healthy vaccinated populations remains uncommon.
authors.affiliation: Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, United States. Electronic address: mmm2@cdc.gov.
authors.forename: Michael M
authors.initials: MM
authors.lastname: McNeil
authors.affiliation: Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, United States.
authors.forename: Maria
authors.initials: M
authors.lastname: Cano
authors.affiliation: Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, United States.
authors.forename: Elaine
authors.initials: E
authors.lastname: R Miller
authors.affiliation: Poxvirus and Rabies Branch, Division of High-Consequence Pathogens and Pathology, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, United States.
authors.forename: Brett W
authors.initials: BW
authors.lastname: Petersen
authors.affiliation: Vaccine Healthcare Centers Network, Military Vaccine Agency, US Army Public Health Command, Walter Reed National Military Medical Center, 8901 Wisconsin Avenue, Bethesda, MD 20889-5600, United States.
authors.forename: Renata J M
authors.initials: RJ
authors.lastname: Engler
authors.affiliation: Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, United States.
authors.forename: Marthe G
authors.initials: MG
authors.lastname: Bryant-Genevier
mesh_terms: D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems; D005260:Female; D006801:Humans; D059232:Laboratory Personnel; D008297:Male; D008875:Middle Aged; D008889:Military Personnel; D009203:Myocardial Infarction / Q000453:epidemiology*; D017202:Myocardial Ischemia / Q000453:epidemiology*; D012900:Smallpox Vaccine / Q000009:adverse effects*; D014611:Vaccination / Q000009:adverse effects*; D055815:Young Adult
chemical_list: C000588544:ACAM2000; D012900:Smallpox Vaccine
keywords: ACAM2000(®); Ischemic cardiac events; Myo/pericarditis; Myocarditis; Pericarditis