Adverse Events Associated With Smallpox Vaccination in the United States, January-October 2003

Casey, Christine

doi:10.1001/jama.294.21.2734

Cited by 178 publications

(163 citation statements)

References 45 publications

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“…A shorter reporting interval provides a better chance for timely detection of serious or life-threatening events and, consequently, timely public health intervention. [16][17][18][19][20][21] Report completeness is critical to the validity of VAERS reports; for example, age and onset interval can provide important information on the biological plausibility of the reported AE being associated with the administered vaccine. [16][17][18][19] IBRs have the potential to reduce transcription and data-entry errors and result in more accurate data.…”

Section: Discussionmentioning

confidence: 99%

“…For the smallpox vaccination program from 2002 to 2004, IBRs resulted in increased proportional usage of electronic reporting (50% vs 13.3% overall usage in VAERS), which in turn contributed to the timely detection of the unanticipated finding of myopericarditis in adults after smallpox vaccination. 20,21 When we excluded smallpox vaccination reports (16%) from the analysis, report completeness and timeliness remained higher for IBRs compared with NIBRs. Hence, IBRs proved to be effective in accomplishing a higher proportion of completeness and timeliness independent of smallpox vaccination publicity.…”

Section: Discussionmentioning

confidence: 99%

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Internet-Based Reporting to the Vaccine Adverse Event Reporting System: A More Timely and Complete Way for Providers to Support Vaccine Safety

Haber¹,

Iskander²,

Walton

et al. 2011

Pediatrics

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BACKGROUND: On March 22, 2002, Internet-based reports (IBRs) were added to the Vaccine Adverse Event Reporting System (VAERS) to allow rapid, expedited reporting of adverse events (AEs) in anticipation of wider use of counter-bioterrorism vaccines such as those against smallpox and anthrax. OBJECTIVES: To evaluate the impact of IBRs on the timeliness and completeness of vaccine AE reporting. METHODS: To evaluate timeliness and completeness, we compared the proportions of IBRs with non–Internet-based reports (NIBRs). Report interval was analyzed for timeliness and age at vaccination, birth date, and onset date for report completeness. To evaluate the impact of the smallpox vaccination program, we compared smallpox vaccine reports separately. Because influenza vaccine is the most widely used vaccine in adults each year, we compared influenza vaccine reports separately. RESULTS: During the study period, VAERS received 54 364 NIBRs (85.8%) and 9008 IBRs (14.2%). Sixteen percent (1455) of IBRs followed smallpox vaccination. Overall, for all vaccines and for smallpox vaccine alone, IBRs had a greater proportion of completeness and a shorter report interval. The proportion of most frequently reported AEs did not differ between IBRs and NIBRs. A higher proportion of adults (18–64 years old) who received influenza vaccine chose to complete an IBR (62% vs 48%). CONCLUSIONS: The improved timeliness and completeness of IBRs allow VAERS to more rapidly detect new or rare vaccine AEs. This important advantage is critical in times of increased public concern about vaccine safety. Clinical vaccine providers should be aware of VAERS and use IBRs whenever feasible to report vaccine AEs.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Internet-Based Reporting to the Vaccine Adverse Event Reporting System: A More Timely and Complete Way for Providers to Support Vaccine Safety

Haber¹,

Iskander²,

Walton

et al. 2011

Pediatrics

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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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“…The first stage of the sensitivity analysis was to generate nine network types by using all combinations of three values for peer-group neighborhood size (n PG ) (8, 10, and 12) and three values for the proportion of peer-group members who were contacts (p WP ) (0.25, 0.5, and 0.75). In the second stage, we used Latin hypercube sampling to randomly select 100 different combinations of the six parameters that determine individual-level infectiousness (sampling range in parentheses; see also Table 2, which is published as supporting information on the PNAS web site): a, the household attack rate, which we defined to be the proportion of susceptible household members infected by a single infectious individual (43-88% (1)); h r/f , infectiousness of an individual with rash relative to infectiousness with fever (1)(2)(3)(4)(5)(6)(7)(8)(9)(10)(11)(12)(13)(14)(15)(16)(17)(18)(19)(20); h h/w , infectiousness of an individual to household members relative to infectiousness to peer-group contacts (1-10);…”

Section: Sensitivity Analysesmentioning

confidence: 99%

“…For scenario C, an additional 13.7 million doses prevented 77 infections. These large numbers of additional vaccinations, and their associated negative side effects, do not justify the infections prevented: During 2003, after the inoculation of 37,901 people in the United States, three deaths, two permanent disabilities, and ten life-threatening illnesses were attributed to vaccination (10).…”

Section: Ntmentioning

confidence: 99%

Smallpox transmission and control: Spatial dynamics in Great Britain

Riley

Ferguson

2006

Proc. Natl. Acad. Sci. U.S.A.

130

114

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Contingency planning for the possible deliberate reintroduction of smallpox has become a priority for many national public health organizations in recent years. We used an individual-based spatial model of smallpox transmission in Great Britain and census-derived journey-to-work data to accurately describe the spatiotemporal dynamics of an outbreak of smallpox in the community. A Markov chain Monte-Carlo algorithm was developed to generate sociospatial contact networks that were consistent with demographic and commuting data. We tested the sensitivity of model predictions to key epidemiological parameters before choosing three representative scenarios from within the range explored. We examined the spatiotemporal dynamics for these illustrative scenarios and assessed the efficacy of symptomatic case isolation, contact tracing with vaccination, and reactive regional mass vaccination as policy options for control. We conclude that case isolation and contact tracing with vaccination would be sufficient to halt ongoing transmission rapidly, unless policy effectiveness was compromised by resource or other constraints. A slight reduction in the expected size and duration of an outbreak could be achieved with regional mass vaccination, but these benefits are small and do not justify the high numbers of vaccine doses required and their associated negative side effects. epidemiology ͉ mathematical model ͉ network ͉ infectious diseases B efore its eradication, smallpox was a directly transmitted respiratory disease caused by the variola viruses. Variola major was highly pathogenic: The mortality rate among the unvaccinated in India in 1974 was 26.5% (1). Despite there being only two recognized laboratories storing variola major virus, an unknown number of covertly held samples of this virus likely remain in existence, raising concern in recent years over the potential for the virus to be used as a bioterrorist weapon. Even a single confirmed case would cause substantial levels of public concern and social disruption. However, the epidemiological consequences of a small number of deliberately introduced infections in a population such as that of Great Britain (GB) (i.e., England , Scotland, and Wales) is not well understood. A number of mathematical modeling studies in recent years have attempted to address this issue, but their results are equivocal (2-5). Furthermore, the likely geographic spread of the disease within contemporary populations has not been modeled. Consequently, uncertainties remain as to the relative effectiveness of different public health interventions that might be implemented in response to a smallpox outbreak.Conceptually, the transmission dynamics of an infectious disease and the potential for control of that disease can be understood in terms of R 0 and . The basic reproductive number, R 0 , for a pathogen is defined to be the average number of secondary infections generated by a typically infectious individual in an otherwise susceptible population. In this definition, the word ''typically'' impl...

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Adverse Events Associated With Smallpox Vaccination in the United States, January-October 2003

Cited by 178 publications

References 45 publications

Internet-Based Reporting to the Vaccine Adverse Event Reporting System: A More Timely and Complete Way for Providers to Support Vaccine Safety

Internet-Based Reporting to the Vaccine Adverse Event Reporting System: A More Timely and Complete Way for Providers to Support Vaccine Safety

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

Smallpox transmission and control: Spatial dynamics in Great Britain

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