Ischemic cardiac events during the Department of Health and Human Services Smallpox Vaccination Program, 2003.
Ten ischemic cardiac events (ICEs) were reported among 37,901 initial US Department of Health and Human Services (DHHS) smallpox vaccinees. Symptoms developed a median of 10 days after vaccination (range, 0-28 days). The median age of case patients was 56 years (range, 42-65 years), and 60% were male. Seven (70%) of the case patients had >/=3 cardiac risk factors or probable coronary artery disease before vaccination. Two women, 55 and 57 years of age, experienced acute myocardial infarction and fatal cardiac arrests. Background rates of ICEs during a 3-week period for civilian populations that were age and sex matched to DHHS vaccinees were estimated. The observed number of myocardial infarctions exceeded estimated expectations (5 vs. 2) but remained within the 95% predictive interval (PI) (0.6-5.4). New onset angina was observed significantly less frequently than estimated expectations (1 vs. 10; 95% PI, 3.5-15.7). After persons with >/=3 cardiac risk factors or known heart disease were deferred from vaccination, no ICEs were reported among an additional 6638 vaccinees.
Swerdlow
David L
DL
Smallpox Vaccine Adverse Events Monitoring and Response Activity, National Immunization Program, Centers for Disease Control and Prevention, Atlanta, Georgia, USA. DLS3@cdc.gov
Roper
Martha H
MH
Morgan
Juliette
J
Schieber
Richard A
RA
Sperling
Laurence S
LS
Sniadack
Mercedes M
MM
Neff
Linda
L
Miller
Jacqueline W
JW
Curtis
Christine R
CR
Marin
Mona E
ME
Iskander
John
J
Moro
Pedro
P
Hightower
Paige
P
Levine
Nancy H
NH
McCauley
Mary
M
Heffelfinger
James
J
Damon
Inger
I
Török
Thomas J
TJ
Wharton
Melinda
M
Mast
Eric E
EE
Mootrey
Gina T
GT
D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems; D005260:Female; D006282:Health Personnel; D006801:Humans; D015994:Incidence; D008297:Male; D032541:Mass Vaccination / Q000009:adverse effects*; D008875:Middle Aged; D017202:Myocardial Ischemia / Q000453:epidemiology* / Q000209:etiology; D018571:Sentinel Surveillance; D012900:Smallpox Vaccine / Q000009:adverse effects*; D014481:United States / Q000453:epidemiology
C078786:DryVax vaccine; D012900:Smallpox Vaccine