Surveillance Guidelines for Smallpox Vaccine (vaccinia) Adverse Reactions

Casey, Christine; Vellozzi, Claudia; Mootrey, Gina T.; Chapman, Louisa E.; McCauley, Mary M.; Roper, Martha H.; Damon, Inger K.; Swerdlow, David L.

doi:10.1037/e506942006-001

Cited by 32 publications

(33 citation statements)

References 23 publications

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“…For our review of possible ICE cases, we classified all cardiovascular AEs based on information from the VAERS form and medical records, death certificates and autopsy reports (when available) according to the following categories: acute myocarditis (suspected, probable, and confirmed) and acute pericarditis (suspected, probable, and confirmed). 27 For ICE cases, we used a modified definition from Swerdlow et al: 14 a primary clinician diagnosis of symptoms consistent with myocardial infarction (MI) or angina pectoris supported by evidence of ischemia by electrocardiogram (ECG), serial cardiac enzyme testing, cardiac catheterization or autopsy.…”

Section: Methodsmentioning

confidence: 99%

Ischemic cardiac events and other adverse events following ACAM2000® smallpox vaccine in the Vaccine Adverse Event Reporting System

McNeil¹,

Cano²,

Miller³

et al. 2014

Vaccine

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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 1,149 reports following ACAM2000® administration; 169 (14.7%) were serious (resulting in permanent disability, hospitalization, life-threatening illnesses 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.

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Section: Methodsmentioning

confidence: 99%

Ischemic cardiac events and other adverse events following ACAM2000® smallpox vaccine in the Vaccine Adverse Event Reporting System

McNeil¹,

Cano²,

Miller³

et al. 2014

Vaccine

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“…The severity of symptoms depends on multiple factors such as vaccinia immunity (including history of vaccinia immunization), general immune status, location or route and dose of exposure, age of the affected person, pre-existing dermatitis disorders, and cardiac diseases, and others. A number of contraindications preclude individuals from vaccinia vaccination (Table 1) (Casey et al, 2006;Rotz et al, 2001;Wharton et al, 2003). Due to potential contact transmissions that may cause secondary or tertiary vaccinia (CDC, 2004a;Garde et al, 2004;Young et al, 2011), contraindications may also exist if close contacts have certain health conditions.…”

Section: Discussionmentioning

confidence: 99%

Vaccinia Virus—Laboratory Tool with a Risk of Laboratory-Acquired Infection

Korioth-Schmitz

Affeln

Simon³

et al. 2015

Appl Biosaf.

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“…5,7,8 Other short-term morbidities may be associated with the smallpox vaccine as well. 4,12 Although smallpox vaccinations are currently being monitored for short-term adverse events, 13,14 no surveillance system is in place to monitor potential long-term adverse outcomes. Using data from Millennium Cohort Study responders, the current report describes an examination of potential long-term subjective health consequences of smallpox vaccination.…”

Section: Discussionmentioning

confidence: 99%

Self-reported adverse health events following smallpox vaccination in a large prospective study of US military service members

Wells¹,

LeardMann²,

Smith³

et al. 2008

Human Vaccines

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© 2 0 0 8 L A N D E S B I O S C I E N C E . D O N O T D I S T R I B U T E .vaccination site. 3 Moderate to severe adverse reactions include bullous erythema multiforme (Stevens-Johnson syndrome), eczema vaccinatum, generalized vaccinia, progressive vaccinia, and postvaccinal encephalitis. 3 More recently, the Department of Defense resumed smallpox vaccination for US military forces amid growing concerns that smallpox might be employed as a bioterrorist weapon. 4 Following reinstatement, reported adverse events were generally mild in nature, with the exception of an increased risk of myopericarditis predominantly among white males aged 21-44 years of age. Onset of myopericarditis symptoms in these cases occurred between 2 to 25 days following primary vaccination. [5][6][7][8][9] Most evaluations of vaccine safety rely on case series or retrospective reviews of acute health care. In contrast, the Millennium Cohort Study, the largest prospective study in military history designed to follow over 140,000 US service members for 21 years from 2001 through 2022, provides a unique opportunity to evaluate a wide range of subacute or chronic health outcomes potentially associated with smallpox vaccine. 10 ResultsOf the 55,021 Millennium Cohort participants who completed both a baseline and follow-up questionnaire, 45,284 had concordant self-reported and electronic smallpox vaccination records. Individuals vaccinated before taking their baseline survey (n = 74), and individuals vaccinated during the 30 days period prior to starting or while taking their follow-up survey (n = 283) were excluded. In addition, individuals who deployed to the Global War on Terrorism (GWOT) before completing their baseline survey (n = 2,378), completed their follow-up survey during a deployment (n = 1,672), or who were missing demographic or military covariate data (n = 405) were excluded. After exclusion criteria were applied, 40,472 individuals remained for analysis, 8,793 of whom received the smallpox vaccine and 31,679 who did not.The population was stratified by deployment status to GWOT, and characteristics of vaccinated and unvaccinated individuals

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Surveillance Guidelines for Smallpox Vaccine (vaccinia) Adverse Reactions

Cited by 32 publications

References 23 publications

Ischemic cardiac events and other adverse events following ACAM2000® smallpox vaccine in the Vaccine Adverse Event Reporting System

Ischemic cardiac events and other adverse events following ACAM2000® smallpox vaccine in the Vaccine Adverse Event Reporting System

Vaccinia Virus—Laboratory Tool with a Risk of Laboratory-Acquired Infection

Self-reported adverse health events following smallpox vaccination in a large prospective study of US military service members

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