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Find video protocols related to scientific articles indexed in Pubmed.
Narcolepsy and influenza A(H1N1) pandemic 2009 vaccination in the United States.
Neurology
PUBLISHED: 10-15-2014
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To assess the occurrence of narcolepsy after influenza vaccines used in the United States that contained the influenza A(H1N1)pdm09 virus strain.
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The Vaccine Safety Datalink: successes and challenges monitoring vaccine safety.
Vaccine
PUBLISHED: 08-06-2014
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The Vaccine Safety Datalink (VSD) is a collaborative project between the Centers for Disease Control and Prevention (CDC) and 9 health care organizations. Established in 1990, VSD is a vital resource informing policy makers and the public about the safety of vaccines used in the United States. Large linked databases are used to identify and evaluate adverse events in over 9 million individuals annually. VSD generates rapid, important safety assessments for both routine vaccinations and emergency vaccination campaigns. VSD monitors safety of seasonal influenza vaccines in near-real time, and provided essential information on the safety of influenza A (H1N1) 2009 monovalent vaccine during the recent pandemic. VSD investigators have published important studies demonstrating that childhood vaccines are not associated with autism or other developmental disabilities. VSD prioritizes evaluation of new vaccines; searches for possible unusual health events after vaccination; monitors vaccine safety in pregnant women; and has pioneered development of biostatistical research methods.
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Intussusception following rotavirus vaccination: an updated review of the available evidence.
Expert Rev Vaccines
PUBLISHED: 07-26-2014
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In 1999, the first rotavirus vaccine licensed in the USA was withdrawn 9 months after introduction due to an association with intussusception that was detected in post-licensure surveillance. This association prompted large clinical trials designed to ensure the safety of two current live oral rotavirus vaccines, RotaTeq and Rotarix, which have since been recommended for use worldwide. Following their introduction, post-licensure studies have focused not only on the effectiveness and impact of these vaccines, but also on continued surveillance for intussusception. Most recent evidence from several countries shows a small increased risk of intussusception following vaccination with Rotarix and RotaTeq within the context of their demonstrated benefits. This review summarizes the available data on the safety of rotavirus vaccines with regards to intussusception.
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Continuous sequential boundaries for vaccine safety surveillance.
Stat Med
PUBLISHED: 02-26-2014
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Various recently developed sequential methods have been used to detect signals for post-marketing surveillance in drug and vaccine safety. Among these, the maximized sequential probability ratio test (MaxSPRT) has been used to detect elevated risks of adverse events following vaccination using large healthcare databases. However, a limitation of MaxSPRT is that it only provides a time-invariant flat boundary. In this study, we propose the use of time-varying boundaries for controlling how type I error is distributed throughout the surveillance period. This is especially useful in two scenarios: (i) when we desire generally larger sample sizes before a signal is generated, for example, when early adopters are not representative of the larger population; and (ii) when it is desired for a signal to be generated as early as possible, for example, when the adverse event is considered rare but serious. We consider four specific time-varying boundaries (which we call critical value functions), and we study their statistical power and average time to signal detection. The methodology we present here can be viewed as a generalization or flexible extension of MaxSPRT.
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Absence of associations between influenza vaccines and increased risks of seizures, Guillain-Barré syndrome, encephalitis, or anaphylaxis in the 2012-2013 season.
Pharmacoepidemiol Drug Saf
PUBLISHED: 02-04-2014
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We conducted weekly surveillance for pre-specified adverse events following receipt of the 2012-2013 influenza vaccines in the Vaccine Safety Datalink (VSD).
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Safety of diphtheria, tetanus, acellular pertussis and inactivated poliovirus (DTaP-IPV) vaccine.
Vaccine
PUBLISHED: 01-24-2014
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In 2008, a diphtheria, tetanus, acellular pertussis, and inactivated poliovirus combined vaccine (DTaP-IPV) was licensed for use in children 4 through 6 years of age. While pre-licensure studies did not demonstrate significant safety concerns, the number vaccinated in these studies was not sufficient to examine the risk of uncommon but serious adverse events.
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Vaccinations given during pregnancy, 2002-2009: a descriptive study.
Am J Prev Med
PUBLISHED: 01-21-2014
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A number of studies have described influenza vaccination coverage during pregnancy but few publications have described rates of other vaccinations.
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Risk of intussusception after monovalent rotavirus vaccination.
N. Engl. J. Med.
PUBLISHED: 01-14-2014
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Although current rotavirus vaccines were not associated with an increased risk of intussusception in large trials before licensure, recent postlicensure data from international settings suggest the possibility of a small increase in risk of intussusception after monovalent rotavirus vaccination. We examined this risk in a population in the United States.
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Protective Association Between Rotavirus Vaccination and Childhood Seizures in the Year Following Vaccination in US Children.
Clin. Infect. Dis.
PUBLISHED: 11-20-2013
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Background.?Rotavirus illness has been linked to childhood seizures. We investigated whether a protective association exists between receipt of rotavirus vaccine and being hospitalized or visiting the emergency department for seizures in the year after vaccination. Methods.?We retrospectively analyzed a cohort of children born after 28 February 2006 (when rotavirus vaccine was licensed in the United States) and enrolled in the Vaccine Safety Datalink (VSD) through November 2009. Seizure rates from 4 to 55 weeks following last rotavirus vaccination were compared by vaccine exposure status (fully vaccinated and unvaccinated). A time-to-event analysis using a Cox proportional hazards model was performed, accounting for time-varying covariates. We calculated the relative incidence of seizure compared by vaccine exposure status during the postexposure interval. Results.?Our cohort contained VSD data on 250 601 infants, including 186 502 children fully vaccinated (74.4%) and 64 099 (25.6%) not vaccinated with rotavirus vaccine. Rates of seizures were associated with rotavirus vaccination status. After adjusting for covariates (VSD site, age at last dose, sex, and calendar month of the index date), a statistically significant protective association was observed between a full course of rotavirus vaccination vs no vaccination for both first-ever seizures (risk ratio [RR] = 0.82; 95% confidence interval [CI], .73-.91) and all seizures (RR = 0.79; 95% CI, .71-.88). Conclusions.?A full course of rotavirus vaccination was statistically associated with an 18%-21% reduction in risk of seizure requiring hospitalization or emergency department care in the year following vaccination, compared with unvaccinated children. This reduction in childhood seizures complements the well-documented vaccine-related benefit of preventing US diarrhea hospitalizations.
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Effect of age on the risk of Fever and seizures following immunization with measles-containing vaccines in children.
JAMA Pediatr
PUBLISHED: 10-16-2013
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IMPORTANCE The first dose of live attenuated measles-containing vaccines is associated with an increased risk of febrile seizures 7 to 10 days following immunization among 12- to 23-month-old children. The combination measles, mumps, rubella, and varicella vaccine is associated with a 2-fold increased risk of febrile seizures 7 to 10 days following immunization compared with the separately administered measles, mumps, and rubella and varicella vaccines. It is unknown whether the magnitude of these increased risks depends on age at immunization. OBJECTIVE To examine the potential modifying effect of age on the risk of fever and seizures following immunization with measles-containing vaccines. DESIGN, SETTING, AND PARTICIPANTS Retrospective cohort study at 8 Vaccine Safety Datalink sites of a total of 840?348 children 12 to 23 months of age who had received a measles-containing vaccine from 2001 through 2011. EXPOSURES Any measles-containing vaccines and measles-containing vaccines by type. MAIN OUTCOMES AND MEASURES Fever and seizure events occurring during a 42-day postimmunization observation period. RESULTS In the analysis of any measles-containing vaccines, the increased risk of seizures during the 7- to 10-day risk interval, using the remainder of the observation period as the control interval, was significantly greater among older children (relative risk, 6.5; 95% CI, 5.3-8.1; attributable risk, 9.5 excess cases per 10?000 doses; 95% CI, 7.6-11.5) than among younger children (relative risk, 3.4; 95% CI, 3.0-3.9; attributable risk?=?4.0 excess cases per 10?000 doses; 95% CI, 3.4-4.6). The relative risk of postimmunization fever was significantly greater among older children than among younger children; however, its attributable risk was not. In the analysis of vaccine type, measles, mumps, rubella, and varicella vaccine was associated with a 1.4-fold increase in the risk of fever and 2-fold increase in the risk of seizures compared with measles, mumps, and rubella vaccine administered with or without varicella vaccine in both younger and older children. CONCLUSIONS AND RELEVANCE Measles-containing vaccines are associated with a lower increased risk of seizures when administered at 12 to 15 months of age. Findings of this study that focused on safety outcomes highlight the importance of timely immunization of children with the first dose of measles-containing vaccines.
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Evaluating the safety of influenza vaccine using a claims-based health system.
Vaccine
PUBLISHED: 06-20-2013
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As part of the Centers for Disease Control and Preventions monitoring and evaluation activities for influenza vaccines, we examined relationships between influenza vaccination and selected outcomes in the 2009-2010 and 2010-2011 influenza seasons in a claims-based data environment.
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Vaccination coverage levels among children enrolled in the Vaccine Safety Datalink.
Vaccine
PUBLISHED: 03-28-2013
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The Vaccine Safety Datalink (VSD) is a collaborative project whose infrastructure provides comprehensive medical and immunization histories for more than 9 million adults and children annually, a predominantly insured population. This study provides the coverage rates of recommended vaccines among children 19-35 months in the VSD from 2005 through 2010. We examine the consistency in vaccine coverage levels, detect possible trends, and evaluate any effect of vaccine shortages on coverage in the VSD.
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Identification of seizures among adults and children following influenza vaccination using health insurance claims data.
Vaccine
PUBLISHED: 03-15-2013
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Post-licensure surveillance of adverse events following vaccination or prescription drug use often relies on electronic healthcare data to efficiently detect and evaluate safety signals. The accuracy of seizure-related diagnosis codes in identifying true incident seizure events in vaccine safety studies is influenced by factors such as clinical setting of diagnosis and age. To date, most studies of post-vaccination seizure have focused on pediatric populations. More information is needed on how well seizure can be identified in adults and children using algorithms that rely on electronic healthcare data.
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Mortality rates and cause-of-death patterns in a vaccinated population.
Am J Prev Med
PUBLISHED: 02-25-2013
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Determining the baseline mortality rate in a vaccinated population is necessary to be able to identify any unusual increases in deaths following vaccine administration. Background rates are particularly useful during mass immunization campaigns and in the evaluation of new vaccines.
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Increasing exposure to antibody-stimulating proteins and polysaccharides in vaccines is not associated with risk of autism.
J. Pediatr.
PUBLISHED: 02-01-2013
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To evaluate the association between autism and the level of immunologic stimulation received from vaccines administered during the first 2 years of life.
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A population-based cohort study of undervaccination in 8 managed care organizations across the United States.
JAMA Pediatr
PUBLISHED: 01-23-2013
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OBJECTIVES To examine patterns and trends of undervaccination in children aged 2 to 24 months and to compare health care utilization rates between undervaccinated and age-appropriately vaccinated children. DESIGN Retrospective matched cohort study. SETTING Eight managed care organizations of the Vaccine Safety Datalink. PARTICIPANTS Children born between 2004 and 2008. MAIN EXPOSURE Immunization records were used to calculate the average number of days undervaccinated. Two matched cohorts were created: 1 with children who were undervaccinated for any reason and 1 with children who were undervaccinated because of parental choice. For both cohorts, undervaccinated children were matched to age-appropriately vaccinated children by birth date, managed care organization, and sex. MAIN OUTCOME MEASURES Rates of undervaccination, specific patterns of undervaccination, and health care utilization rates. RESULTS Of 323 247 children born between 2004 and 2008, 48.7% were undervaccinated for at least 1 day before age 24 months. The prevalence of undervaccination and specific patterns of undervaccination increased over time (P < .001). In a matched cohort analysis, undervaccinated children had lower outpatient visit rates compared with children who were age-appropriately vaccinated (incidence rate ratio [IRR], 0.89; 95% CI, 0.89- 0.90). In contrast, undervaccinated children had increased inpatient admission rates compared with age-appropriately vaccinated children (IRR, 1.21; 95% CI, 1.18-1.23). In a second matched cohort analysis, children who were undervaccinated because of parental choice had lower rates of outpatient visits (IRR, 0.94; 95% CI, 0.93-0.95) and emergency department encounters (IRR, 0.91; 95% CI, 0.88-0.94) than age-appropriately vaccinated children. CONCLUSIONS Undervaccination appears to be an increasing trend. Undervaccinated children appear to have different health care utilization patterns compared with age-appropriately vaccinated children.
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Vaccination site and risk of local reactions in children 1 through 6 years of age.
Pediatrics
PUBLISHED: 01-14-2013
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Our objective was to assess whether the occurrence of medically attended local reactions to intramuscularly administered vaccines varies by injection site (arm versus thigh) in children 1 to 6 years of age.
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Adapting group sequential methods to observational postlicensure vaccine safety surveillance: results of a pentavalent combination DTaP-IPV-Hib vaccine safety study.
Am. J. Epidemiol.
PUBLISHED: 01-04-2013
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To address gaps in traditional postlicensure vaccine safety surveillance and to promote rapid signal identification, new prospective monitoring systems using large health-care database cohorts have been developed. We newly adapted clinical trial group sequential methods to this observational setting in an original safety study of a combination diphtheria and tetanus toxoids and acellular pertussis adsorbed (DTaP), inactivated poliovirus (IPV), and Haemophilus influenzae type b (Hib) conjugate vaccine (DTaP-IPV-Hib) among children within the Vaccine Safety Datalink population. For each prespecified outcome, we conducted 11 sequential Poisson-based likelihood ratio tests during September 2008-January 2011 to compare DTaP-IPV-Hib vaccinees with historical recipients of other DTaP-containing vaccines. No increased risk was detected among 149,337 DTaP-IPV-Hib vaccinees versus historical comparators for any outcome, including medically attended fever, seizure, meningitis/encephalitis/myelitis, nonanaphylactic serious allergic reaction, anaphylaxis, Guillain-Barré syndrome, or invasive Hib disease. In end-of-study prespecified subgroup analyses, risk of medically attended fever was elevated among 1- to 2-year-olds who received DTaP-IPV-Hib vaccine versus historical comparators (relative risk = 1.83, 95% confidence interval: 1.34, 2.50) but not among infants under 1 year old (relative risk = 0.83, 95% confidence interval: 0.73, 0.94). Findings were similar in analyses with concurrent comparators who received other DTaP-containing vaccines during the study period. Although lack of a controlled experiment presents numerous challenges, implementation of group sequential monitoring methods in observational safety surveillance studies is promising and warrants further investigation.
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Postlicensure surveillance for pre-specified adverse events following the 13-valent pneumococcal conjugate vaccine in children.
Vaccine
PUBLISHED: 01-02-2013
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Although no increased risk was detected for serious adverse events in the prelicensure trials for the 13-valent pneumococcal vaccine, Prevnar 13(®) (PCV13), continued monitoring of rare but serious adverse events is necessary. A surveillance system using cohort study design was set up to monitor safety of PCV13 immediately after it was included in the childhood immunization program in the United States. The exposed population included children of 1 month to 2 years old who received PCV13 from April, 2010 to January, 2012 from the eight managed care organizations participating in the Vaccine Safety Datalink Project in the United States. The historical unexposed population was children of the same age who received the 7-valent pneumococcal conjugate vaccine Prevnar 7(®) (PCV7) in 2007 (or 2005 depending on the outcome of interest) to 2009. The risk of pre-specified adverse events in the risk window following PCV13 was repeatedly compared to that in the historical comparison group. The number of doses included in the study was 599,229. No increased risk was found for febrile seizures, urticaria or angioneurotic edema, asthma, thrombocytopenia, or anaphylaxis. An increased risk for encephalopathy was not confirmed following the medical record review. The relative risk for Kawasaki disease in 0-28 days following vaccination was 1.94 (95% confidence interval: 0.79-4.86), comparing PCV13 to PCV7. Comparing to PCV7 vaccine, we identified no significant increased risk of pre-specified adverse events in the Vaccine Safety Datalink study cohort. The possible association between PCV13 and Kawasaki disease may deserve further investigation.
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Guillain-Barré Syndrome, Influenza Vaccination, and Antecedent Respiratory and Gastrointestinal Infections: A Case-Centered Analysis in the Vaccine Safety Datalink, 2009-2011.
PLoS ONE
PUBLISHED: 01-01-2013
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Guillain-Barré Syndrome (GBS) can be triggered by gastrointestinal or respiratory infections, including influenza. During the 2009 influenza A (H1N1) pandemic in the United States, monovalent inactivated influenza vaccine (MIV) availability coincided with high rates of wildtype influenza infections. Several prior studies suggested an elevated GBS risk following MIV, but adjustment for antecedent infection was limited.
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Trivalent inactivated influenza vaccine is not associated with sickle cell crises in children.
Pediatrics
PUBLISHED: 12-12-2011
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Children with sickle cell disease are considered at high risk for complications from influenza infection and are recommended to receive annual influenza vaccination. However, data on the safety of influenza vaccination in children with sickle cell anemia are sparse.
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Safety of trivalent inactivated influenza vaccine in children aged 24 to 59 months in the vaccine safety datalink.
Arch Pediatr Adolesc Med
PUBLISHED: 08-04-2011
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To evaluate the safety of trivalent inactivated influenza vaccine (TIV) in children aged 24 to 59 months and to evaluate the risk of medically attended events (MAEs) in a subcohort of children who had multiple annual doses of TIV over their lifetimes.
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Monitoring the safety of quadrivalent human papillomavirus vaccine: findings from the Vaccine Safety Datalink.
Vaccine
PUBLISHED: 07-27-2011
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In 7 large managed care organizations (MCOs), we performed a post-licensure safety assessment of quadrivalent human papillomavirus vaccine (HPV4) among 9-26 year-old female vaccine recipients between August 2006 and October 2009.
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Thimerosal exposure in early life and neuropsychological outcomes 7-10 years later.
J Pediatr Psychol
PUBLISHED: 07-23-2011
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The authors used a public use data set to investigate associations between the receipt of thimerosal-containing vaccines and immune globulins early in life and neuropsychological outcomes assessed at 7-10 years.
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Near real-time vaccine safety surveillance with partially accrued data.
Pharmacoepidemiol Drug Saf
PUBLISHED: 05-04-2011
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The Vaccine Safety Datalink (VSD) Project conducts near real-time vaccine safety surveillance using sequential analytic methods. Timely surveillance is critical in identifying potential safety problems and preventing additional exposure before most vaccines are administered. For vaccines that are administered during a short period, such as influenza vaccines, timeliness can be improved by undertaking analyses while risk windows following vaccination are ongoing and by accommodating predictable and unpredictable data accrual delays. We describe practical solutions to these challenges, which were adopted by the VSD Project during pandemic and seasonal influenza vaccine safety surveillance in 2009/2010.
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Active surveillance for adverse events: the experience of the Vaccine Safety Datalink project.
Pediatrics
PUBLISHED: 04-18-2011
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To describe the Vaccine Safety Datalink (VSD) projects experience with population-based, active surveillance for vaccine safety and draw lessons that may be useful for similar efforts.
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The Vaccine Safety Datalink: a model for monitoring immunization safety.
Pediatrics
PUBLISHED: 04-18-2011
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The Vaccine Safety Datalink (VSD) project is a collaborative project between the Centers for Disease Control and Prevention and 8 managed care organizations (MCOs) in the United States. Established in 1990 to conduct postmarketing evaluations of vaccine safety, the project has created an infrastructure that allows for high-quality research and surveillance. The 8 participating MCOs comprise a large population of 8.8 million members annually (3% of the US population), which enables researchers to conduct studies that assess adverse events after immunization. Each MCO prepares computerized data files by using a standardized data dictionary containing demographic and medical information on its members, such as age and gender, health plan enrollment, vaccinations, hospitalizations, outpatient clinic visits, emergency department visits, urgent care visits, and mortality data, as well as additional birth information (eg, birth weight) when available. Other information sources, such as medical chart review, member surveys, and pharmacy, laboratory, and radiology data, are often used in VSD studies to validate outcomes and vaccination data. Since 2000, the VSD has undergone significant changes including an increase in the number of participating MCOs and enrolled population, changes in data-collection procedures, the creation of near real-time data files, and the development of near real-time postmarketing surveillance for newly licensed vaccines or changes in vaccine recommendations. Recognized as an important resource in vaccine safety, the VSD is working toward increasing transparency through data-sharing and external input. With its recent enhancements, the VSD provides scientific expertise, continues to develop innovative approaches for vaccine-safety research, and may serve as a model for other patient safety collaborative research projects.
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H1N1 and seasonal influenza vaccine safety in the vaccine safety datalink project.
Am J Prev Med
PUBLISHED: 03-09-2011
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The emergence of pandemic H1N1 influenza virus in early 2009 prompted the rapid licensure and use of H1N1 monovalent inactivated (MIV) and live, attenuated (LAMV) vaccines separate from seasonal trivalent inactivated (TIV) and live, attenuated (LAIV) influenza vaccines. A robust influenza immunization program in the U.S. requires ongoing monitoring of potential adverse events associated with vaccination.
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Monitoring vaccine safety using the Vaccine Safety Datalink: utilizing immunization registries for pandemic influenza.
Vaccine
PUBLISHED: 02-09-2011
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Mass vaccination campaigns during which new vaccines may be administered to many millions of people in a short period of time call for timely and accurate post-licensure surveillance to monitor vaccine safety. To address the need for timely H1N1 influenza vaccine safety information during the 2009-2010 H1N1 influenza pandemic, the Vaccine Safety Datalink (VSD) project assessed the feasibility and potential mechanisms for utilizing data from state and local immunization registries to capture vaccinations that would not otherwise be captured by the data systems of the participating VSD managed care organizations (MCOs). Three of the eight VSD sites were able to capture H1N1 immunization data electronically from the state and local registries, and one site was able to capture the immunizations through a paper-based system; however, the remaining four sites encountered various obstacles that prevented capture of such data. Additional work will be required at these sites to overcome the barriers, which included privacy and confidentiality laws, time constraints brought on by the pandemic, as well as data quality concerns.
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Benzodiazepine use and misuse among patients in a methadone program.
BMC Psychiatry
PUBLISHED: 01-13-2011
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Benzodiazepines (BZD) misuse is a serious public health problem, especially among opiate-dependent patients with anxiety enrolled in methadone program because it puts patients at higher risk of life-threatening multiple drug overdoses. Both elevated anxiety and BZD misuse increase the risk for ex-addicts to relapse. However, there is no recent study to assess how serious the problem is and what factors are associated with BZD misuse. This study estimates the prevalence of BZD misuse in a methadone program, and provides information on the characteristics of BZD users compared to non-users.
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Prenatal and infant exposure to thimerosal from vaccines and immunoglobulins and risk of autism.
Pediatrics
PUBLISHED: 09-13-2010
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Exposure to thimerosal, a mercury-containing preservative that is used in vaccines and immunoglobulin preparations, has been hypothesized to be associated with increased risk of autism spectrum disorder (ASD). This study was designed to examine relationships between prenatal and infant ethylmercury exposure from thimerosal-containing vaccines and/or immunoglobulin preparations and ASD and 2 ASD subcategories: autistic disorder (AD) and ASD with regression.
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Lack of association between acellular pertussis vaccine and seizures in early childhood.
Pediatrics
PUBLISHED: 07-19-2010
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Receipt of diphtheria-tetanus-whole-cell pertussis vaccine (diphtheria-tetanus toxoids-pertussis [DTP]) is associated with seizures. Limited population-based studies have been conducted on the risk for seizures after receipt of diphtheria-tetanus-acellular pertussis vaccine (diphtheria-tetanus-acellular pertussis [DTaP]).
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Measles-mumps-rubella-varicella combination vaccine and the risk of febrile seizures.
Pediatrics
PUBLISHED: 06-29-2010
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In February 2008, we alerted the Advisory Committee on Immunization Practices to preliminary evidence of a twofold increased risk of febrile seizures after the combination measles-mumps-rubella-varicella (MMRV) vaccine when compared with separate measles-mumps-rubella (MMR) and varicella vaccines. Now with data on twice as many vaccine recipients, our goal was to reexamine seizure risk after MMRV vaccine.
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Accuracy of influenza vaccination status in a computer-based immunization tracking system of a managed care organization.
Vaccine
PUBLISHED: 05-06-2010
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Influenza vaccine safety and effectiveness studies conducted using electronic medical records rely on accurate assessment of influenza vaccination status. However, influenza immunization in non-traditional settings (e.g., the workplace) may not be captured in patient immunization tracking systems. We compared influenza vaccination status from electronic records with self-reported vaccination status for five hundred and two 50-79 years olds enrolled in a large managed care organization. Influenza vaccination status in the medical record had a high positive predictive value and specificity (both >99%). The negative predictive value was 80% and sensitivity was 78%. These data suggest that an electronic record of influenza vaccination reliably indicates immunization, while the absence of such a record is only moderately accurate, partly due to vaccines received in non-traditional settings.
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Near real-time surveillance for influenza vaccine safety: proof-of-concept in the Vaccine Safety Datalink Project.
Am. J. Epidemiol.
PUBLISHED: 12-04-2009
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The emergence of pandemic H1N1 influenza in 2009 has prompted public health responses, including production and licensure of new influenza A (H1N1) 2009 monovalent vaccines. Safety monitoring is a critical component of vaccination programs. As proof-of-concept, the authors mimicked near real-time prospective surveillance for prespecified neurologic and allergic adverse events among enrollees in 8 medical care organizations (the Vaccine Safety Datalink Project) who received seasonal trivalent inactivated influenza vaccine during the 2005/06-2007/08 influenza seasons. In self-controlled case series analysis, the risk of adverse events in a prespecified exposure period following vaccination was compared with the risk in 1 control period for the same individual either before or after vaccination. In difference-in-difference analysis, the relative risk in exposed versus control periods each season was compared with the relative risk in previous seasons since 2000/01. The authors used Poisson-based analysis to compare the risk of Guillain-Barré syndrome following vaccination in each season with that in previous seasons. Maximized sequential probability ratio tests were used to adjust for repeated analyses on weekly data. With administration of 1,195,552 doses to children under age 18 years and 4,773,956 doses to adults, no elevated risk of adverse events was identified. Near real-time surveillance for selected adverse events can be implemented prospectively to rapidly assess seasonal and pandemic influenza vaccine safety.
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Estimating influenza-associated deaths in the United States.
Am J Public Health
PUBLISHED: 10-03-2009
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Most estimates of US deaths associated with influenza circulation have been similar despite the use of different approaches. However, a recently published estimate suggested that previous estimates substantially overestimated deaths associated with influenza, and concluded that substantial numbers of deaths during a future pandemic could be prevented because of improvements in medical care. We reviewed the data sources and methods used to estimate influenza-associated deaths. We suggest that discrepancies between the recent estimate and previous estimates of the number of influenza-associated deaths are attributable primarily to the use of different outcomes and methods. We also believe that secondary bacterial infections will likely result in substantial morbidity and mortality during a future influenza pandemic, despite medical progress.
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MCV vaccination in the presence of vaccine-associated Guillain-Barré Syndrome risk: a decision analysis approach.
Vaccine
PUBLISHED: 08-24-2009
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The study evaluates the benefits of meningococcal conjugate vaccine (MCV4) vaccination against the burden of vaccine-associated Guillain-Barré Syndrome (GBS) using simulation. An 11-year-old cohort was followed over an 8-year period in a simulation model Table 3 Figs. 1 and 2 to estimate health outcomes to assist decision makers in setting policy. Applying a 3% discount rate, MCV4 vaccination would save 2397 quality-adjusted life years (QALYs) while vaccine-attributable GBS could result in 5 QALYs lost. Based on the result, MCV4 vaccination is strongly favored despite possible vaccine-associated GBS risk.
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Estimates of US influenza-associated deaths made using four different methods.
Influenza Other Respir Viruses
PUBLISHED: 05-21-2009
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A wide range of methods have been used for estimating influenza-associated deaths in temperate countries. Direct comparisons of estimates produced by using different models with US mortality data have not been published.
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Accuracy of data on influenza vaccination status at four Vaccine Safety Datalink sites.
Am J Prev Med
PUBLISHED: 04-27-2009
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Studies of influenza vaccination using electronic medical records rely on accurate classification of vaccination status. Vaccinations not entered into electronic records would be unavailable for study.
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An assessment of the safety of adolescent and adult tetanus-diphtheria-acellular pertussis (Tdap) vaccine, using active surveillance for adverse events in the Vaccine Safety Datalink.
Vaccine
PUBLISHED: 04-08-2009
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Using a new sequential analytic method, the safety of tetanus-diphtheria-acellular pertussis (Tdap) vaccine was monitored weekly among subjects aged 10-64 years during 2005-2008. Encephalopathy-encephalitis-meningitis, paralytic syndromes, seizures, cranial nerve disorders, and Guillain-Barré syndrome were selected as outcomes based on previous reports and biologic plausibility. The risk following Tdap was not significantly higher than the risk after Td. Statistical power was sufficient to detect a relative risk of 4-5 for Guillain-Barré syndrome and 1.5-2 for the other outcomes. This study provides reassurance that Tdap is similar in safety to Td regarding the outcomes studied and supports the viability of sequential analysis for post-licensure vaccine safety monitoring.
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Uptake of meningococcal conjugate vaccine among adolescents in large managed care organizations, United States, 2005: demand, supply and seasonality.
BMC Infect. Dis.
PUBLISHED: 04-07-2009
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In February 2005, the US Advisory Committee on Immunization Practices recommended the new meningococcal conjugate vaccine (MCV4) for routine use among 11- to 12-year-olds (at the preadolescent health-care visit), 14- to 15-year-olds (before high-school entry), and groups at increased risk. Vaccine distribution started in March; however, in July, the manufacturer reported inability to meet demand and widespread MCV4 shortages were reported. Our objectives were to determine early uptake patterns among target (11-12 and 14-15 year olds) and non-target (13- plus 16-year-olds) age groups. A post hoc analysis was conducted to compare seasonal uptake patterns of MCV4 with polysaccharide meningococcal (MPSV4) and tetanus diphtheria (Td) vaccines.
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Predictive value of seizure ICD-9 codes for vaccine safety research.
Vaccine
PUBLISHED: 03-25-2009
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Post-licensure vaccine safety studies often monitor for seizures using automated screening of ICD-9 codes. This study assessed the positive predictive value (PPV) of ICD-9 codes used to identify seizure visits in children aged 6 weeks to 23 months who were enrolled in seven managed care organizations during January 2000 to December 2005. ICD-9 codes were used to identify visits for seizures in the 0-30-day period following receipt of a pneumococcal vaccine. Visits were stratified by setting of diagnosis (emergency department (ED), outpatient, and inpatient). Review of medical records confirmed whether the visit represented a true acute seizure event. 3233 visits for seizures were identified; 1024 were randomly selected for medical record review and 859 (84%) had records available. The PPV of ICD-9 codes was highest in the ED setting (97%), followed by the inpatient setting (64%). In the outpatient setting, computerized codes for seizures had very low PPV: 16% on days 1-30 following vaccination and 2% for visits on the same day of vaccination. An estimated 77% of true seizures identified were from the ED or inpatient settings. In conclusion, when using ICD-9 codes to identify seizure outcomes, restricting to the ED and inpatient settings of diagnosis may result in less biased preliminary analyses and more efficient vaccine safety studies.
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Burden of acute gastroenteritis hospitalizations and emergency department visits in US children that is potentially preventable by rotavirus vaccination: a probe study using the now-withdrawn rotashield vaccine.
Pediatrics
PUBLISHED: 03-04-2009
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With the implementation of a new rotavirus immunization program in the United States in 2006, determining the potential health benefits of rotavirus vaccination is important. We estimated the burden of acute gastroenteritis hospitalizations and emergency department visits in US children that are potentially preventable by rotavirus vaccination.
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Brief vs. extended buprenorphine detoxification in a community treatment program: engagement and short-term outcomes.
Am J Drug Alcohol Abuse
PUBLISHED: 02-10-2009
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Despite evidence supporting the efficacy of buprenorphine relative to established detoxification agents such as clonidine, little research has examined: 1) how best to implement buprenorphine detoxification in outpatient settings; and 2) whether extending the length of buprenorphine detoxification improves treatment engagement and outcomes.
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Secular trends in diagnostic code density in electronic healthcare data from health care systems in the Vaccine Safety Datalink project.
Vaccine
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Large observational vaccine safety studies often use automated diagnoses extracted from medical care databases to identify pre-specified potential adverse events following immunization (AEFI). We assessed the secular trends and variability in the number of diagnoses per encounter regardless of immunization status referred as diagnostic code density, by healthcare setting, age, and pre-specified condition in eight large health care systems of the Vaccine Safety Datalink project during 2001-2009. An increasing trend in diagnostic code density was observed in all healthcare settings and age groups, with variations across the sites. Sudden increases in diagnostic code density were observed at certain sites when changes in coding policies or data inclusion criteria took place. When vaccine safety studies use an historical comparator, the increased diagnostic code density over time may generate low expected rates (based on historical data) and high observed rates (based on current data), suggesting a false positive association between a vaccine and AEFI. The ongoing monitoring of the diagnostic code density can provide guidance on study design and choice of appropriate comparison groups. It can also be used to ensure data quality and allow timely correction of errors in an active safety surveillance system.
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Safety of a tetanus-diphtheria-acellular pertussis vaccine when used off-label in an elderly population.
Clin. Infect. Dis.
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Published data on the safety of tetanus-diphtheria-acellular pertussis vaccine (Tdap) in persons aged ?65 years are limited. This study aims to examine a large cohort of Tdap users ?65 years for evidence of increased risk of adverse events following vaccination.
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Adding integrative meditation with ear acupressure to outpatient treatment of cocaine addiction: a randomized controlled pilot study.
J Altern Complement Med
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Cocaine addiction continues to be a major public health problem in the United States. With no U.S. Food and Drug Administration-approved pharmaceutical therapy, treatment often relies on psychosocial interventions. This pilot therapy development study attempts to examine the feasibility and preliminary efficacy of adding breathing-based Integrative Meditation and Ear Acupressure (IMEA) to outpatient treatment of cocaine addiction.
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Guillain-Barré syndrome incidence in a large United States cohort (2000-2009).
Neuroepidemiology
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We describe the incidence of Guillain-Barré syndrome (GBS) in a large United States cohort.
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Risk of confirmed Guillain-Barre syndrome following receipt of monovalent inactivated influenza A (H1N1) and seasonal influenza vaccines in the Vaccine Safety Datalink Project, 2009-2010.
Am. J. Epidemiol.
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An increased risk of Guillain-Barré syndrome (GBS) following administration of the 1976 swine influenza vaccine led to a heightened focus on GBS when monovalent vaccines against a novel influenza A (H1N1) virus of swine origin were introduced in 2009. GBS cases following receipt of monovalent inactivated (MIV) and seasonal trivalent inactivated (TIV) influenza vaccines in the Vaccine Safety Datalink Project in 2009-2010 were identified in electronic data and confirmed by medical record review. Within 1-42 days following vaccination, 9 cases were confirmed in MIV recipients (1.48 million doses), and 8 cases were confirmed in TIV-only recipients who did not also receive MIV during 2009-2010 (1.72 million doses). Five cases following MIV and 1 case following TIV-only had an antecedent respiratory infection, a known GBS risk factor; furthermore, unlike TIV, MIV administration was concurrent with heightened influenza activity. In a self-controlled risk interval analysis comparing GBS onset within 1-42 days following MIV with GBS onset 43-127 days following MIV, the risk difference was 5.0 cases per million doses (95% confidence interval: 0.5, 9.5). No statistically significant increased GBS risk was found within 1-42 days following TIV-only vaccination versus 43-84 days following vaccination (risk difference = 1.1 cases per million doses, 95% confidence interval: -3.1, 5.4). Further evaluation to assess GBS risk following both vaccination and respiratory infection is warranted.
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Measles-containing vaccines and febrile seizures in children age 4 to 6 years.
Pediatrics
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In the United States, children receive 2 doses of measles-mumps-rubella vaccine (MMR) and varicella vaccine (V), the first between ages 1 to 2 years and the second between ages 4 to 6 years. Among 1- to 2-year-olds, the risk of febrile seizures 7 to 10 days after MMRV is double that after separate MMR + V. Whether MMRV or MMR + V affects risk for febrile seizure risk among 4- to 6-year-olds has not been reported.
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Risk of intussusception following administration of a pentavalent rotavirus vaccine in US infants.
JAMA
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Current rotavirus vaccines were not associated with intussusception in large prelicensure trials. However, recent postlicensure data from international settings suggest the possibility of a low-level elevated risk, primarily in the first week after the first vaccine dose.
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Challenges in the design and analysis of sequentially monitored postmarket safety surveillance evaluations using electronic observational health care data.
Pharmacoepidemiol Drug Saf
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Many challenges arise when conducting a sequentially monitored medical product safety surveillance evaluation using observational electronic data captured during routine care. We review existing sequential approaches for potential use in this setting, including a continuous sequential testing method that has been utilized within the Vaccine Safety Datalink (VSD) and group sequential methods, which are used widely in randomized clinical trials.
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What is Visualize?

JoVE Visualize is a tool created to match the last 5 years of PubMed publications to methods in JoVE's video library.

How does it work?

We use abstracts found on PubMed and match them to JoVE videos to create a list of 10 to 30 related methods videos.

Video X seems to be unrelated to Abstract Y...

In developing our video relationships, we compare around 5 million PubMed articles to our library of over 4,500 methods videos. In some cases the language used in the PubMed abstracts makes matching that content to a JoVE video difficult. In other cases, there happens not to be any content in our video library that is relevant to the topic of a given abstract. In these cases, our algorithms are trying their best to display videos with relevant content, which can sometimes result in matched videos with only a slight relation.