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Biomedical subjects

Robert Ball

Publications and source records attributed to Robert Ball.

At least 19 recordsLinked to original sources
PubMed2006

Passive surveillance for generalized vaccinia in the United States using the Vaccine Adverse Event Reporting System (VAERS).

BACKGROUND: Generalized vaccinia (GV) is an adverse event specifically associated with smallpox vaccination, but shares clinical features with many common non-vaccine related rashes. We assessed the utility of passive reporting for GV surveillance by reviewing all Vaccine Adverse Event Reporting System (VAERS) reports of any post-smallpox vaccination rash in civilians and military personnel. METHODS: We reviewed all reports submitted to VAERS between 12/12/2002 and 3/1 2004 for post-smallpox vaccine (SPV) rashes concerning civilians and military personnel. We evaluated the information contained in the reports independent of VAERS adverse event coding (GV or not GV). We classified the rash reports based on the recently published GV case definition from the Centers for Disease Control and Prevention. RESULTS: Of the 936 rash reports after SPV, 92 were coded as GV. We classified 12 of the 92 as probable GV, and 1 as confirmed GV (14% probable or confirmed). Among the 844 reports not coded as GV, we classified 32 as either probable or confirmed GV (4%). Probable or confirmed reports that were coded as GV were similar to probable or confirmed reports not coded as GV with respect to demographic characteristics of the report subjects, and the location and phenotype (e.g., pustular, vesicular, etc.) of the rashes. CONCLUSIONS: A prospective study that applies well-defined clinical, histopathological, and laboratory criteria to smallpox-vaccinated patients with rashes would be necessary to distinguish GV from common alternative diagnoses with which it is easily confused.

Adult↗
PubMed2006

Monochorionic twin gestation complicated by a sacrococcygeal teratoma with hydrops--optimal timing of delivery allows for survival of the unaffected twin.

Sacrococcygeal teratomas are the most common tumors found in newborns and have a favorable outcome when diagnosed late in gestation. Solid, highly vascularized tumors diagnosed early in gestation have a higher incidence of hydrops fetalis and fetal demise. The following is a case report of a monochorionic twin gestation complicated by a solid highly vascular sacrococcygeal teratoma and the development of hydrops in the affected twin. In this case, serial ultrasound evaluations and timing of delivery optimized the outcome of the unaffected twin.

Adult↗
PubMed2006

Spontaneous rupture of fetal sacrococcygeal teratoma.

With recent advances in technology, fetal sacrococcygeal teratoma is being diagnosed increasingly during the early prenatal period by ultrasound examination. In addition, early detection of tumor related complications such as polyhydramnios, congestive heart failure, hydrops, hemorrhage, urinary tract or bowel obstruction can be followed closely in utero. Active prenatal management can improve fetal perinatal outcome by allowing planned delivery for neonatal surgery [Chisholm, C.A. et al.: Am J Perinatol 1999;16:47-50] or in some cases, fetal intervention. Additionally, families can be counseled appropriately regarding the range of outcomes. We report a case of fetal sacrococcygeal teratoma Type I diagnosed at 20 weeks with a prominent vessel supplying the tumor mass. At 23 weeks, there was a sudden appearance of an additional lobular mass, consistent with intrauterine spontaneous ruptured of a sacrococcygeal teratoma mass.

Adult↗
PubMed2005

Adverse events reported following live, cold-adapted, intranasal influenza vaccine.

CONTEXT: In June 2003, the US Food and Drug Administration licensed a trivalent live, attenuated influenza vaccine (LAIV-T) for intranasal administration to healthy persons 5 to 49 years of age. Although prelicensure testing involved 20 228 vaccinees, clinical trials were not of sufficient size to detect rare adverse events reliably. OBJECTIVE: To identify adverse events reported following LAIV-T administration after licensure. DESIGN, SETTING, AND PARTICIPANTS: All adverse events reported to the US Vaccine Adverse Event Reporting System (VAERS) during the 2003-2004 and the 2004-2005 influenza seasons. MAIN OUTCOME MEASURES: Numbers and proportions of reported adverse events and reporting rates of adverse events per 100,000 vaccinees. RESULTS: Approximately 2,500,000 persons received LAIV-T during the first 2 postlicensure seasons. As of August 16, 2005, VAERS received 460 adverse event reports for vaccinations received from August 2003 through July 2005. No fatalities were reported. There were 7 reports of possible anaphylaxis, 2 reports of Guillain-Barré syndrome, 1 report of Bell palsy, and 8 reports of asthma exacerbation among individuals with a prior asthma history. Events in individuals for whom the vaccine was not indicated accounted for 73 reports (16%). CONCLUSIONS: Reports to VAERS in the first 2 seasons of LAIV-T use did not identify any unexpected serious risks with this vaccine when used according to approved indications. Like many vaccines and other medical products, LAIV-T may rarely cause anaphylaxis. Secondary transmission of the vaccine virus merits further investigation. Reports of asthma exacerbations in vaccinees with prior asthma history highlight the risks of vaccine use inconsistent with approved labeling.

Administration, Intranasal↗
PubMed2005

Adverse events after hepatitis A B combination vaccine.

In May 2001, the U.S. Food and Drug Administration (FDA) approved Hepatitis A Inactivated and Hepatitis B Recombinant Vaccine (HEPAB) for immunization of adults. From May 2001 to September 2003, the Vaccine Adverse Event Reporting System (VAERS) received 305 reports of adverse events after HEPAB. Many events were similar to those reported after the monovalent hepatitis A and B vaccines. Non-serious events included constitutional symptoms and local reactions. Serious events included neurologic, hepatobiliary, and dermatologic conditions, and detailed medical and epidemiological review did not suggest a clear pattern of evidence supporting a causal relationship with the vaccine, except for injection site reactions and some allergic reactions.

Adverse Drug Reaction Reporting Systems↗
PubMed2005

Using simulation to assess the sensitivity and specificity of a signal detection tool for multidimensional public health surveillance data.

The objective of the work described in this paper is to develop a means for characterizing the validity of an empirical methodology for detecting signals potentially related to complicated adverse event (AE) coding terms in multidimensional public health surveillance data. The signal detection tool under evaluation is the multi-item gamma Poisson shrinkage (MGPS) estimation program. We were interested in its potential application to passive surveillance system monitoring, to screen for 'signals' of complicated adverse event coding terms (AE terms) in complex and noisy data. The research was to design and produce a flexible and user-friendly utility for probabilistically defining complicated signals in a database, iterating large numbers of applications of the MGPS detection algorithm and establishing proportions of correct detection events. We sought to establish the specificity of the MGPS by developing a random background using a gradient that ranged from rigorous (but not very relevant) to relevant (but noisy). To establish the sensitivity, signals were defined based on recognized public health issues of interest (such as the introduction of a new vaccine into the population). Methods of representing a signal included a simple pair-wise association consisting of a new vaccine and one AE term, as well as a more realistic complex of multiple AE terms comprising a 'syndrome'. A web application has been developed to create and insert signals with user-defined probabilities in multiple iterations of simulated random background data. Three forms of simulated data based on the vaccine adverse event reporting system (VAERS) cumulative spontaneous database were defined to serve as background noise against which to contrast introduced vaccine adverse event signals: (1) completely random associations between vaccines and AE terms, (2) random associations of vaccine sets and AE term sets preserving naturally observed vaccine co-occurrences and AE term co-occurrences and (3) samples from the actual VAERS data as reported. Rates of detection by the MGPS algorithm can be established for specific signal patterns at varying probabilistic intensities in a choice of random background data forms. Knowing these rates is important for determining the degree of response to an MGPS signal detection event in 'live' data.

Computer Simulation↗
PubMed2005

Comparing data mining methods on the VAERS database.

PURPOSE: Data mining may enhance traditional surveillance of vaccine adverse events by identifying events that are reported more commonly after administering one vaccine than other vaccines. Data mining methods find signals as the proportion of times a condition or group of conditions is reported soon after the administration of a vaccine; thus it is a relative proportion compared across vaccines, and not an absolute rate for the condition. The Vaccine Adverse Event Reporting System (VAERS) contains approximately 150 000 reports of adverse events that are possibly associated with vaccine administration. METHODS: We studied four data mining techniques: empirical Bayes geometric mean (EBGM), lower-bound of the EBGM's 90% confidence interval (EB05), proportional reporting ratio (PRR), and screened PRR (SPRR). We applied these to the VAERS database and compared the agreement among methods and other performance properties, particularly focusing on the vaccine-event combinations with the highest numerical scores in the various methods. RESULTS: The vaccine-event combinations with the highest numerical scores varied substantially among the methods. Not all combinations representing known associations appeared in the top 100 vaccine-event pairs for all methods. CONCLUSIONS: The four methods differ in their ranking of vaccine-COSTART pairs. A given method may be superior in certain situations but inferior in others. This paper examines the statistical relationships among the four estimators. Determining which method is best for public health will require additional analysis that focuses on the true alarm and false alarm rates using known vaccine-event associations. Evaluating the properties of these data mining methods will help determine the value of such methods in vaccine safety surveillance.

Adverse Drug Reaction Reporting Systems↗
PubMed2005

Pre-emptive placement of a presealant for amniotic access.

OBJECTIVE: Amniotic access for fetal diagnosis and therapy can lead to membrane leaks, separation, and preterm premature rupture of membranes. Morbidity limits the beneficial effects of fetal intervention. We propose to examine a novel preventive "presealant" membrane puncture technique and evaluate it in vitro. STUDY DESIGN: Fetal membranes from normal term deliveries were fastened to a pressure controlled pump and punctured after presealant placement. Distinct bioadhesives were then compared for sealing efficacy by the measurement of leak pressures. Membranes were also evaluated for changes in tensile rupture strength after treatment. RESULTS: Preemptive sealing by 2 of the presealants achieved significantly higher leak pressures compared with control membranes (85 and 78, respectively, vs 27 cm of water; P < .05). One of the presealants worked effectively in a membrane-sealant-membrane interface (62 vs 30 cm of water; P < .05). All treated membranes, however, demonstrated diminished tensile rupture forces compared with control membranes (124 vs 170 g/cm2; P > .05). CONCLUSION: The application of a presealant is effective for the prevention of iatrogenic rupture in an in vitro model and may be beneficial for clinical application. Further studies with different bioadhesives are needed, given the limitations of the glues that are described in this study.

Cyanoacrylates↗
PubMed2005

Transient bulging fontanelle after vaccination: case report and review of the vaccine adverse event reporting system.

OBJECTIVE: To describe the features of transient bulging fontanelle (TBF) after vaccination. STUDY DESIGN: We searched the Vaccine Adverse Event Reporting System database for reports describing bulging fontanelle. We defined a definite TBF case as a patient with a bulging fontanelle, normal neuroimaging and cerebrospinal fluid analysis, and absence of a depressed level of consciousness, focal neurologic findings, or identified cause. Follow-up had to reveal normal development. Probable cases lacked either lumbar puncture or neuroimaging or both but met all other criteria. RESULTS: We identified 18 patients with definite or probable TBF. The median age at presentation was 4.5 months, interval from vaccination to symptom onset was 18 hours, and time to resolution was 3 days. Fifteen children were febrile. CONCLUSIONS: We cannot conclude that vaccines cause TBF. Further controlled studies are necessary. Even if further research verifies TBF as a rare side effect, immunization benefits would still vastly outweigh this hypothetical risk. However, confirmation of a vaccine association could modify the management of infants who develop TBF after immunizations.

Adverse Drug Reaction Reporting Systems↗
PubMed2005

Adverse events after inactivated influenza vaccination among children less than 2 years of age: analysis of reports from the vaccine adverse event reporting system, 1990-2003.

BACKGROUND: In April 2002, the Advisory Committee on Immunization Practices (ACIP) encouraged providers to vaccinate healthy 6- to 23-month-old infants and children with trivalent influenza vaccine (TIV). OBJECTIVES: To describe adverse events (AEs) reported to the Vaccine Adverse Event Reporting System (VAERS) after TIV vaccination among children <2 years of age and to compare reports before the ACIP guideline (January 1990 to June 2002) and after the ACIP guideline (July 2002 to June 2003). METHODS: VAERS is a passive vaccine safety surveillance system begun by the Food and Drug Administration and the Centers for Disease Control and Prevention in 1990. We reviewed reports to VAERS for children <2 years of age who received TIV, alone or in combination with other vaccines. Influenza seasons were defined as the period from July 1 of one year to June 30 of the following year. RESULTS: Between 1990 and 2003, VAERS received 166 TIV reports for children <2 years of age. There were 62 reports (37%) after administration of TIV alone and 104 reports (63%) after administration of TIV and > or =1 other vaccine. Approximately one third of reports (N = 61) were in the post-ACIP guideline period. The 4 most frequent AE coding terms were fever (N = 59, 35%), unspecified or urticarial rash (42, 25%), seizure (28, 17%), and injection site reaction (28, 17%). The median number of days from vaccination to symptom onset, the percentage of reports that represented serious AEs, and the gender distribution were similar in the pre-ACIP guideline and post-ACIP guideline periods. The percentage of reports describing an underlying medical condition for the subject decreased from 58% before the ACIP guideline to 37% after the ACIP guideline. Nineteen of 28 seizure reports (68%) described fever with the seizure within 2 days after vaccination. Seizure was the most frequent coding term (N = 10, 7 with fever) among 23 serious reports. The annual number of TIV-related VAERS reports for children <2 years of age increased in the post-ACIP guideline period, probably at least in part because of an increase in the number of vaccinees after the ACIP announcement. The safety profiles in the pre-ACIP guideline and post-ACIP guideline periods were similar. CONCLUSIONS: In October 2003, the ACIP recommended that all healthy children 6 to 23 months of age be vaccinated with TIV, starting in the 2004-2005 influenza season. This study provides generally reassuring, although limited, data regarding the safety of TIV among children in this age range. Continued surveillance for seizures and other clinically significant AEs is warranted and will continue.

Adverse Drug Reaction Reporting Systems↗
PubMed2005

Perspectives on the use of data mining in pharmaco-vigilance.

In the last 5 years, regulatory agencies and drug monitoring centres have been developing computerised data-mining methods to better identify reporting relationships in spontaneous reporting databases that could signal possible adverse drug reactions. At present, there are no guidelines or standards for the use of these methods in routine pharmaco-vigilance. In 2003, a group of statisticians, pharmaco-epidemiologists and pharmaco-vigilance professionals from the pharmaceutical industry and the US FDA formed the Pharmaceutical Research and Manufacturers of America-FDA Collaborative Working Group on Safety Evaluation Tools to review best practices for the use of these methods.In this paper, we provide an overview of: (i) the statistical and operational attributes of several currently used methods and their strengths and limitations; (ii) information about the characteristics of various postmarketing safety databases with which these tools can be deployed; (iii) analytical considerations for using safety data-mining methods and interpreting the results; and (iv) points to consider in integration of safety data mining with traditional pharmaco-vigilance methods. Perspectives from both the FDA and the industry are provided. Data mining is a potentially useful adjunct to traditional pharmaco-vigilance methods. The results of data mining should be viewed as hypothesis generating and should be evaluated in the context of other relevant data. The availability of a publicly accessible global safety database, which is updated on a frequent basis, would further enhance detection and communication about safety issues.

Adverse Drug Reaction Reporting Systems↗
PubMed2004

Postlicensure safety surveillance for 7-valent pneumococcal conjugate vaccine.

CONTEXT: Clinical trials evaluate a vaccine's safety before approval, but some risks may escape detection or adequate characterization until larger population exposures occur after licensure. OBJECTIVE: To summarize reports of events occurring after vaccination with 7-valent pneumococcal conjugate vaccine (PCV), including those that may warrant further investigation to assess possible causation by PCV. DESIGN: Descriptive epidemiology of reports submitted to the Vaccine Adverse Event Reporting System (VAERS), a national passive surveillance database. SETTING AND PATIENTS: United States during first 2 years after licensure of PCV (February 2000 through February 2002). Reports studied were for children younger than 18 years and vaccinated with PCV. MAIN OUTCOME MEASURES: Numbers and proportional distributions of reports. RESULTS: A total of 4154 reports of events following PCV were submitted to VAERS, for a rate of 13.2 reports per 100,000 doses distributed. Multiple vaccines were given in 74.3% of reports. The most frequently reported symptoms and signs included fever, injection site reactions, fussiness, rashes, and urticaria. Serious events were described in 14.6% of reports. There were 117 deaths, 23 reports of positive rechallenges, and 34 cases of invasive pneumococcal infections possibly representing vaccine failure. Immune-mediated events occurred in 31.3% of reports. All 14 patients with anaphylactic or anaphylactoid reactions survived. Thrombocytopenia developed in 14 patients and serum sickness in 6 others. Neurologic symptoms occurred in 38% of reports. Seizures described in 393 reports included 94 febrile seizures. CONCLUSIONS: The majority of reports to VAERS in the first 2 years after licensure of PCV described generally minor adverse events previously identified in clinical trials. The proportion of reports portraying serious events was similar to that for other vaccines. Although there are important limitations in passive surveillance data, and caution in their interpretation is necessary, symptoms experienced by a few children more than once after successive PCV doses, including allergic reactions, prolonged or abnormal crying, fussiness, dyspnea, and gastrointestinal distress, warrant continued surveillance, as do reports of rare but potentially serious events, such as seizures, anaphylactic or anaphylactoid reactions, serum sickness, and thrombocytopenia.

Adolescent↗
PubMed2004

Postmarketing safety surveillance for typhoid fever vaccines from the Vaccine Adverse Event Reporting System, July 1990 through June 2002.

Vaccines against Salmonella enterica serotype Typhi are used for prophylaxis of international travelers and have potential use as counterbioterrorism agents. The Vaccine Adverse Event Reporting System (VAERS) cannot usually establish causal relationships between vaccines and reported adverse events without further research but has successfully detected unrecognized side effects of vaccine. We reviewed reports to VAERS for US-licensed typhoid fever vaccines for the period of July 1990 through June 2002. We received 321 reports for parenteral Vi capsular polysaccharide vaccine and 345 reports for live, oral, attenuated Ty21a vaccine, with 7.5% and 5.5%, respectively, describing death, hospitalization, permanent disability, or life-threatening illness. Unexpected frequently reported symptoms included dizziness and pruritus for Vi vaccine and fatigue and myalgia for Ty21a vaccine. Gastroenteritis-like illness after receipt of Ty21a vaccine and abdominal pain after receipt of Vi vaccine, which are previously recognized events, occasionally required hospitalization. Nonfatal anaphylaxis was reported after both vaccines. VAERS reports do not indicate any unexpected serious side effects that compromise these vaccines' use for travelers' prophylaxis.

Adverse Drug Reaction Reporting Systems↗
PubMed2004

Understanding vaccine safety information from the Vaccine Adverse Event Reporting System.

The Vaccine Adverse Event Reporting System (VAERS) is administered by the Food and Drug Administration and CDC and is a key component of postlicensure vaccine safety surveillance. Its primary function is to detect early warning signals and generate hypotheses about possible new vaccine adverse events or changes in frequency of known ones. VAERS is a passive surveillance system that relies on physicians and others to voluntarily submit reports of illness after vaccination. Manufacturers are required to report all adverse events of which they become aware. There are a number of well-described limitations of such reporting systems. These include, for example, variability in report quality, biased reporting, underreporting and the inability to determine whether a vaccine caused the adverse event in any individual report. Strengths of VAERS are that it is national in scope and timely. The information in VAERS reports is not necessarily complete nor is it verified systematically. Reports are classified as serious or nonserious based on regulatory criteria. Reports are coded by VAERS in a uniform way with a limited number of terms using a terminology called COSTART. Coding is useful for search purposes but is necessarily imprecise. VAERS is useful in detecting adverse events related to vaccines and most recently was used for enhanced reporting of adverse events in the national smallpox immunization campaign. VAERS data have always been publicly available. However, it is essential for users of VAERS data to be fully aware of the strengths and weaknesses of the system. VAERS data contain strong biases. Incidence rates and relative risks of specific adverse events cannot be calculated. Statistical significance tests and confidence intervals should be used with great caution and not routinely. Signals detected in VAERS should be subjected to further clinical and descriptive epidemiologic analysis. Confirmation in a controlled study is usually required. An understanding of the system's defined objectives and inherent drawbacks is vital to the effective use of VAERS data in vaccine safety investigations.

Adverse Drug Reaction Reporting Systems↗
PubMed2004

Vaccine risk perception among reporters of autism after vaccination: vaccine adverse event reporting system 1990-2001.

OBJECTIVES: We investigated vaccine risk perception among reporters of autism to the Vaccine Adverse Event Reporting System (VAERS). METHODS: We conducted structured interviews with 124 parents who reported autism and related disorders to VAERS from 1990 to 2001 and compared results with those of a published survey of parents in the general population. RESULTS: Respondents perceived vaccine-preventable diseases as less serious than did other parents. Only 15% of respondents deemed immunization extremely important for children's health; two thirds had withheld vaccines from their children. CONCLUSIONS: Views of parents who believe vaccines injured their children differ significantly from those of the general population regarding the benefits of immunization. Understanding the factors that shape this perspective can improve communication among vaccine providers, policymakers, and parents/patients.

Adult↗
PubMed2004

Polyarteritis nodosa reports to the vaccine adverse event reporting system (VAERS): implications for assessment of suspected vaccine-provoked vasculitis.

OBJECTIVE: To examine polyarteritis nodosa (PAN) reports to the Vaccine Adverse Event Reporting System (VAERS) as the initial stage in investigating the hypothesis that vaccination can very rarely cause PAN. METHODS: We reviewed PAN reports submitted from 1990 through 2001 using a causal inference framework to evaluate the consistency of the reports' clinical details with this hypothesis. We also reviewed published literature relating to the hypothesized association's biological plausibility. RESULTS: VAERS received 25 PAN reports. Ten met our case definition for definite or possible PAN and had no alternative etiology for PAN identified. Nine of these 10 followed hepatitis B vaccine with a modal peak (4 definite cases) in time to symptom onset 2 weeks after vaccination. However, all potential triggering infections were not excluded, and identification of vaccine antigens in clinical specimens was not attempted. Also, 14 of 25 reports were European, with 11 from France. All 9 French reports with a known diagnosis date began during 1994-97, when autoimmune and rheumatologic events following hepatitis B vaccine were a focus of public concern in France. CONCLUSION: While we identified some supportive evidence, overall, current adverse event reports do not support a causal link between vaccination and PAN. Appropriate prospective evaluation of future post-vaccination PAN cases could add to current knowledge with rigorous confirmation of diagnosis, appropriate testing for possible triggering infections including polymerase chain reaction testing for latent hepatitis B infection, and an attempt to link the vaccine antigen to pathology such as by immunohistochemical staining or immune complex identification.

Adolescent↗
PubMed2003

Extensive limb swelling after immunization: reports to the Vaccine Adverse Event Reporting System.

Extensive limb swelling (ELS) has been reported after vaccination with a limited number of vaccine types. We sought to describe vaccine types involved in and the clinical characteristics of ELS cases reported to the Vaccine Adverse Event Reporting System (VAERS). A case of ELS was defined as any report of edema extending at least to the elbow or knee of a vaccinated extremity. Four hundred ninety-seven cases were identified, with some describing swelling from the shoulder to the hand or the hip to the foot. Patient age ranged from 0.1 to 91 years. The proportion of reports of ELS associated with a given vaccine, among all VAERS reports received for that vaccine, varied substantially among vaccines. Most reactions began within 1 day after vaccination and involved other signs of inflammation. Postvaccination ELS can involve both the proximal and distal segments of the extremity, affects all age groups, and occurs after vaccination with a broad range of vaccines.

Adolescent↗