Pseudomonas aeruginosa bloodstream infections in children and adolescents: risk factors associated with carbapenem resistance and mortality.

BACKGROUND: Pseudomonas aeruginosa bloodstream infections (PA-BSIs) are a serious disease and a therapeutic challenge due to increasing resistance to carbapenems. Our objectives were to describe the prevalence and risk factors associated with carbapenem resistance (CR) and mortality in children with PA-BSI. METHODS: A retrospective, multi-centre study was carried out, including patients aged <20 years with PA-BSI in four tertiary hospitals in Madrid (Spain) during 2010-2020. Risk factors for CR PA-BSIs and 30-day mortality were evaluated in a multi-variable logistic regression model. RESULTS: In total, 151 patients with PA-BSI were included, with a median age of 29 months (interquartile range: 3.5-87.1). Forty-five (29.8%) cases were CR, 9.9% multi-drug resistant and 6.6% extensively drug resistant. The prevalence of CR remained stable throughout the study period, with 26.7% (12/45) of CR mediated by VIM-type carbapenemase. Patients with BSIs produced by CR-PA were more likely to receive inappropriate empiric treatment (53.3% vs 5.7%, P<0.001) and to have been previously colonized by CR-PA (8.9% vs 0%, P=0.002) than BSIs caused by carbapenem-susceptible P. aeruginosa. CR was associated with carbapenem treatment in the previous month (adjusted odds ratio (aOR) 11.15) and solid organ transplantation (aOR 7.64). The 30-day mortality was 23.2%, which was associated with mechanical ventilation (aOR 4.24), sepsis (aOR 5.72), inappropriate empiric antibiotic therapy (aOR 5.86), and source control as a protective factor (aOR 0.16). CONCLUSION: This study shows a concerning prevalence of CR in children with PA-BSIs, leading to high mortality. Inappropriate empiric treatment and sepsis were associated with mortality. The high prevalence of CR with an increased risk of inappropriate empiric treatment should be closely monitored.

Is there potential for estradiol receptor signaling in lophotrochozoans?

Estrogen receptors (ERs) are thought to be the ancestor of all steroid receptors and are present in most lophotrochozoans studied to date, including molluscs, annelids, and rotifers. A number of studies have investigated the functional role of estrogen receptors in invertebrate species, although most are in molluscs, where the receptor is constitutively active. In vitro experiments provided evidence for ligand-activated estrogen receptors in annelids, raising important questions about the role of estrogen signalling in lophotrochozoan lineages. Here, we review the concordant and discordant evidence of estradiol receptor signalling in lophotrochozoans, with a focus on annelids and rotifers. We explore the de novo synthesis of estrogens, the evolution and expression of estrogen receptors, and physiological responses to activation of estrogen receptors in the lophotrochozoan phyla Annelida and Rotifera. Key data are missing to determine if de novo biosynthesis of estradiol in non-molluscan lophotrochozoans is likely. For example, an ortholog for the CYP11 gene is present, but confirmation of substrate conversion and measured tissue products is lacking. Orthologs CYP17 and CYP19 are lacking, yet intermediates or products (e.g. estradiol) in tissues have been measured. Estrogen receptors are present in multiple species, and for a limited number, in vitro data show agonist binding of estradiol and/or transcriptional activation. The expression patterns of the lophotrochozoan ERs suggest developmental, reproductive, and digestive roles but are highly species dependent. E2 exposures suggest that lophotrochozoan ERs may play a role in reproduction, but no strong dose-response relationship has been established. Therefore, we expect most lophotrochozoan species, outside of perhaps platyhelminths, to have an ER but their physiological role remains elusive. Mining genomes for orthologs gene families responsible for steroidogenesis, coupled with in vitro and in vivo studies of the steroid pathway are needed to better assess whether lophotrochozoans are capable of estradiol biosynthesis. One major challenge is that much of the data are divided across a diversity of species. We propose that the polychaetes Capitella teleta or Platyneris dumerilii, and rotifer Brachionus manjavacas may be strong species choices for studies of estrogen receptor signalling, because of available genomic data, established laboratory culture techniques, and gene knockout potential.

Identifying imprints of externally derived dust and halogens in the sedimentary record of an Iberian alpine lake for the past ∼13,500 years - Lake Peixão, Serra da Estrela (Central Portugal).

Iberian lacustrine sediments are a valuable archive to document environmental changes since the last glacial termination, seen as key for anticipating future climate/environmental changes and their far-reaching implications for generations to come. Herein, multi-proxy-based indicators of a mountain lake record from Serra da Estrela were used to reconstruct atmospheric (in)fluxes and associated climatic/environmental changes over the last ∼13.5 ka. Depositions of long-range transported dust (likely from the Sahara) and halogens (primarily derived from seawater) were higher for the pre-Holocene, particularly in the late Bølling-Allerød-Younger Dryas period, compared to the Holocene. This synchronous increase could be related to a recognized dust-laden atmosphere, along with the combined effect of (i) an earlier proposed effective transport of Sahara dust for higher latitudes during cold periods and (ii) the progressive Polar Front expansion southwards, with the amplification of halogen activation reactions in lower latitudes due to greater closeness to snow/sea ice (halide-laden) surfaces. Additionally, the orographic blocking of Serra da Estrela may have played a critical role in increasing precipitation of Atlantic origin at higher altitudes, with the presence of snow prompting physical and chemical processes involving halogen species. In the Late Holocene, the dust proxy records highlighted two periods of enhanced input to Lake Peixão, the first (∼3.5-2.7 ka BP) after the end of the last African Humid Period and the second, from the 19th century onwards, agreeing with the advent of commercial agriculture, and human contribution to land degradation and dust emission in the Sahara/Sahel region. The oceanic imprints throughout the Holocene matched well with North Atlantic rapid climatic changes that, in turn, coincided with ice-rafted debris or Bond events and other records of increased storminess for the European coasts. Positive parallel peaks in halogens were found in recent times, probably connected to fire extinction by halogenated alkanes and roadway de-icing.

A cold wave of winter 2021 in central South America: characteristics and impacts.

During the austral winter (June-August) of 2021, the meteorological services of Brazil, Argentina, Peru, Paraguay, Bolivia, and Chile all issued forecasts for unusually cold conditions. Record-low minimum temperatures and cold spells were documented, including one strong cold wave episode that affected 5 countries. In this study, we define a cold wave as a period in which daily maximum and minimum air temperatures are below the corresponding climatological 10th percentile for three or more consecutive days. The intense cold wave event in the last week of June, 2021, resulted in record-breaking minimum daily temperatures in several places in central South America and Chile. Several locations had temperatures about 10 °C below average, central South America had freezing conditions, and southern Brazil even saw snow. The cold air surge was characterized by an intense upper-air trough located close to 35° S and 70° W. The southerly flow to the west of this trough brought very cold air northward into subtropical and tropical South America. A northward flow between the lower-level cyclonic and anticyclonic perturbations caused the intense southerly flow between the upper-level ridge and trough. This condition facilitated the inflow of near-surface cold air from southern Argentina into southeastern Brazil and tropical South America east of the Andes. In the city of São Paulo, the cold wave caused the death of 13 homeless people from hypothermia. Frost and snow across southern and southeastern Brazil caused significant damage to coffee, sugarcane, oranges, grapes, and other fruit and vegetable crops. Wine and coffee production fell, the latter by 30%, and prices of food and commodities in the region rose. Supplementary Information: The online version contains supplementary material available at 10.1007/s00382-023-06701-1.

Increases in Future AR Count and Size: Overview of the ARTMIP Tier 2 CMIP5/6 Experiment.

The Atmospheric River (AR) Tracking Method Intercomparison Project (ARTMIP) is a community effort to systematically assess how the uncertainties from AR detectors (ARDTs) impact our scientific understanding of ARs. This study describes the ARTMIP Tier 2 experimental design and initial results using the Coupled Model Intercomparison Project (CMIP) Phases 5 and 6 multi-model ensembles. We show that AR statistics from a given ARDT in CMIP5/6 historical simulations compare remarkably well with the MERRA-2 reanalysis. In CMIP5/6 future simulations, most ARDTs project a global increase in AR frequency, counts, and sizes, especially along the western coastlines of the Pacific and Atlantic oceans. We find that the choice of ARDT is the dominant contributor to the uncertainty in projected AR frequency when compared with model choice. These results imply that new projects investigating future changes in ARs should explicitly consider ARDT uncertainty as a core part of the experimental design.

Modeling the impact of SARS-CoV-2 variants and vaccines on the spread of COVID-19.

The continuous mutation of SARS-CoV-2 opens the possibility of the appearance of new variants of the virus with important differences in its spreading characteristics, mortality rates, etc. On 14 December 2020, the United Kingdom reported a potentially more contagious coronavirus variant, present in that country, which is referred to as VOC 202012/01. On 18 December 2020, the South African government also announced the emergence of a new variant in a scenario similar to that of the UK, which is referred to as variant 501.V2. Another important milestone regarding this pandemic was the beginning, in December 2020, of vaccination campaigns in several countries. There are several vaccines, with different characteristics, developed by various laboratories and research centers. A natural question arises: what could be the impact of these variants and vaccines on the spread of COVID-19? Many models have been proposed to simulate the spread of COVID-19 but, to the best of our knowledge, none of them incorporates the effects of potential SARS-CoV-2 variants together with the vaccines in the spread of COVID-19. We develop here a θ - i j -SVEIHQRD mathematical model able to simulate the possible impact of this type of variants and of the vaccines, together with the main mechanisms influencing the disease spread. The model may be of interest for policy makers, as a tool to evaluate different possible future scenarios. We apply the model to the particular case of Italy (as an example of study case), showing different outcomes. We observe that the vaccines may reduce the infections, but they might not be enough for avoiding a new wave, with the current expected vaccination rates in that country, if the control measures are relaxed. Furthermore, a more contagious variant could increase significantly the cases, becoming the most common way of infection. We show how, even with the pandemic cases slowing down (with an effective reproduction number less than 1) and the disease seeming to be under control, the effective reproduction number of just the new variant may be greater than 1 and, eventually, the number of infections would increase towards a new disease wave. Therefore, a rigorous follow-up of the evolution of the number of infections with any potentially more dangerous new variant is of paramount importance at any stage of the pandemic.

Review of expandable dental implants.

In the last few years the dental implants market has grown both in developed and developing countries, and is associated with high aesthetic expectations and well-being. Although the success rate of commercial implants is high, some problems associated with a lack of initial stability, marginal bony resorption, and periodontal health, remain, especially with immediate placement and loading. The market offers different designs of dental implants, but cylindrical and tapered devices that are fixed to the bone via an external thread are dominant. One lesser-known but potentially useful design is the expandable dental implant (EDI). This paper presents a review of expandable dental implants that encompasses a survey of the literature, published patents, and available commercial devices. We found 15 articles: prospective human trials (n=4), human case reports (n=3), published independent discussions of other articles (n=2), three big animal trials (n=3), and in silico studies (n=3). A total of 73 published patents were found and two expandable dental implants are commercially available to date. We propose a classification system that differentiates between the expansion mechanism and the origin of the expanding action. Some expandable designs have been shown to provide good primary stability, but evidence to date is limited. We encourage future clinical and biomechanical studies to clarify and optimise the potential benefits of these implants.

A simple but complex enough θ -SIR type model to be used with COVID-19 real data. Application to the case of Italy.

Since the start of the COVID-19 pandemic in China many models have appeared in the literature, trying to simulate its dynamics. Focusing on modeling the biological and sociological mechanisms which influence the disease spread, the basic reference example is the SIR model. However, it is too simple to be able to model those mechanisms (including the three main types of control measures: social distancing, contact tracing and health system measures) to fit real data and to simulate possible future scenarios. A question, then, arises: how much and how do we need to complexify a SIR model? We develop a θ -SEIHQRD model, which may be the simplest one satisfying the mentioned requirements for arbitrary territories and can be simplified in particular cases. We show its very good performance in the Italian case and study different future scenarios.

Mathematical modeling of the spread of the coronavirus disease 2019 (COVID-19) taking into account the undetected infections. The case of China.

In this paper we develop a mathematical model for the spread of the coronavirus disease 2019 (COVID-19). It is a new θ-SEIHRD model (not a SIR, SEIR or other general purpose model), which takes into account the known special characteristics of this disease, as the existence of infectious undetected cases and the different sanitary and infectiousness conditions of hospitalized people. In particular, it includes a novel approach that considers the fraction θ of detected cases over the real total infected cases, which allows to study the importance of this ratio on the impact of COVID-19. The model is also able to estimate the needs of beds in hospitals. It is complex enough to capture the most important effects, but also simple enough to allow an affordable identification of its parameters, using the data that authorities report on this pandemic. We study the particular case of China (including Chinese Mainland, Macao, Hong-Kong and Taiwan, as done by the World Health Organization in its reports on COVID-19), the country spreading the disease, and use its reported data to identify the model parameters, which can be of interest for estimating the spread of COVID-19 in other countries. We show a good agreement between the reported data and the estimations given by our model. We also study the behavior of the outputs returned by our model when considering incomplete reported data (by truncating them at some dates before and after the peak of daily reported cases). By comparing those results, we can estimate the error produced by the model when identifying the parameters at early stages of the pandemic. Finally, taking into account the advantages of the novelties introduced by our model, we study different scenarios to show how different values of the percentage of detected cases would have changed the global magnitude of COVID-19 in China, which can be of interest for policy makers.

Saharan dust intrusions in the Iberian Peninsula: Predominant synoptic conditions.

The Iberian Peninsula (IP) is recurrently affected by dust transport from the Sahara Desert and from the semi-arid Sahel regions. African dust is one of the most important sources of particulate matter in the southern Mediterranean. Therefore, it is vital to understand the underlying processes that lead to episodes of air pollution associated to the occurrence of dust intrusions. This work proposes to make an extended characterization of the preferential circulation weather patterns associated to the onset of dust events affecting the IP between 2006 and 2016. Saharan dust intrusions were analysed and an automatic objective classification procedure was used to classify circulation weather patterns associated to dust events. The spatial distribution of intrusion episodes is not homogeneous throughout the IP, occurring less frequently at northern and northwestern locations than at central and southern sites. Moreover, days with Saharan dust intrusions were more frequent in summer months, and more probable to occur under regimes with a southerly component. Finally, two extreme events with high concentration of particulate matter were analysed relatively to their life-cycle and particle trajectories. The distinct extreme episodes can be associated to different synoptic situations. However, and despite different large-scale configurations, a south or south-easterly component over the region is responsible for the establishment of a dust transport from the Saharan region towards Iberia, and thus leading to the intrusion onset. These results were supported by the calculation of back-trajectories which allowed to source apportioning the particles' origin, through a clear trajectory of air parcels originating from northern Africa in both events. The proposed framework can be useful to the prediction of dust and air pollution events based on the forecast of circulation weather patterns, as the results show that these events across the IP are mainly induced by specific patterns.

Rapid assessment of enhanced safety surveillance for influenza vaccine.

OBJECTIVES: The enhanced safety surveillance for seasonal influenza vaccines established by the European Medicines Agency is required each season. Therefore, a registry capable of rapidly detecting and evaluating potential new safety concerns is needed. The aim of the study is to demonstrate the effectiveness of the vaccine information system of the Valencia region to make a rapid assessment of the influenza vaccine safety and describe the safety of the two vaccine types used in the 2017/2018 season. STUDY DESIGN: It is a population-based descriptive study. METHODS: Adverse events following immunization reports collected from 23rd October 2017 to 15th March 2018 were analyzed. RESULTS: A total of 55 adverse events for influenza vaccine were reported in season 2017/2018 with a reporting rate (RR) of 0.77 per 10,000 administered doses. Injection site reactions had a RR of 0.30 and 0.47 per 10,000 for subunit and adjuvanted vaccines, respectively. Differences per vaccine, sex, and risk group did not reach statistical significance. CONCLUSIONS: Reported events of the two influenza vaccine types used were similar than in other seasons and consistent with their safety profiles.

Modeling of the burst release from PLGA micro- and nanoparticles as function of physicochemical parameters and formulation characteristics.

A substantial drug release from poly(lactic-co-glycolic) acid (PLGA) micro- and nanoparticles can occur in the first hours of immersion, which is referred to as burst release. A strong burst release (when not intentional) is to be avoided as it decreases the efficacy of the treatment and could be dangerous to the host. In this work we analyze the total amount of drug released during burst and respective kinetics in relation to formulations characteristics, experimental conditions and drug molecular properties in 154 drug release experiments with 41 different drugs by partial least squares (PLS) and decision tree regression. The model created enables to quantify to which degree the physicochemical parameters control the burst release from PLGA particles. Our analysis shows that the amount of drug released during burst is mostly influenced by the formulation characteristics and the synthesis parameters, whereas the drug release kinetics is also influenced by the molecular properties of the drug. The variables that significantly influence the amount and kinetics of the burst release are discussed in detail and compared with findings from other researchers. The final regression models are shown to predict the release profile of a new drug, opening the possibility to be applied to systematically manipulate the burst release by means of designing an optimized drug delivery system.

Surveillance for adverse events following immunization (AEFI) for 7 years using a computerised vaccination system.

OBJECTIVES: The surveillance of vaccine safety is an essential requirement in vaccination programmes. Computerized immunization registries such as the Vaccination Information System (SIV) of Valencian Community (Spain) offer the opportunity to estimate the incidence of adverse events according to individual information. The aim of the study was to analyze adverse events following immunization reported through SIV from 2005 to 2011 by age, sex, type of vaccine and dose, and adverse event, and highlight the advantages of this type of reporting. STUDY DESIGN: A retrospective cohort study of subjects vaccinated in the Valencian Community using population health databases was carried out. METHODS: Analysis of vaccinations and reported AEFI via SIV in Valencian Community was carried out. RESULTS: More than 13 million vaccines doses were administered during 2005 through 2011, the reporting rate of adverse events was 12.4/100,000 doses administered with the highest value in 2009 (27.4), with differences by age and sex. DTaP vaccine had the highest reporting in children (96.6/100,000) while influenza A(H1N1)pdm09 in adults (87.7/100,000). An increased reporting of adverse events was seen with DTaP in children 5-6 years of age, detected in real time, drove to swap this vaccine to a low dose Tdap which was followed by a decrease in administration site events. CONCLUSIONS: SIV demonstrates advantages for passive surveillance. Reporting rates by individual characteristics are calculated accurately and it also allows detecting shifts in reporting rate on real time for specific vaccines. The study shows that vaccines included in the routine vaccination schedule for children and adult vaccination programs are safe.

Implementation and validation of an economic module in the Be-FAST model to predict costs generated by livestock disease epidemics: Application to classical swine fever epidemics in Spain.

Be-FAST is a computer program based on a time-spatial stochastic spread mathematical model for studying the transmission of infectious livestock diseases within and between farms. The present work describes a new module integrated into Be-FAST to model the economic consequences of the spreading of classical swine fever (CSF) and other infectious livestock diseases within and between farms. CSF is financially one of the most damaging diseases in the swine industry worldwide. Specifically in Spain, the economic costs in the two last CSF epidemics (1997 and 2001) reached jointly more than 108 million euros. The present analysis suggests that severe CSF epidemics are associated with significant economic costs, approximately 80% of which are related to animal culling. Direct costs associated with control measures are strongly associated with the number of infected farms, while indirect costs are more strongly associated with epidemic duration. The economic model has been validated with economic information around the last outbreaks in Spain. These results suggest that our economic module may be useful for analysing and predicting economic consequences of livestock disease epidemics.

Pathology of congenital Zika syndrome in Brazil: a case series

Zika virus is an arthropod-borne virus that is a member of the family Flaviviridae transmitted mainly by mosquitoes of the genus Aedes. Although usually asymptomatic, infection can result in a mild and self-limiting illness characterised by fever, rash, arthralgia, and conjunctivitis. An increase in the number of children born with microcephaly was noted in 2015 in regions of Brazil with high transmission of Zika virus. More recently, evidence has been accumulating supporting a link between Zika virus and microcephaly. Here, we describe findings from three fatal cases and two spontaneous abortions associated with Zika virus infection.

A multi-analysis approach for space-time and economic evaluation of risks related with livestock diseases: the example of FMD in Peru.

This study presents a multi-disciplinary decision-support tool, which integrates geo-statistics, social network analysis (SNA), spatial-stochastic spread model, economic analysis and mapping/visualization capabilities for the evaluation of the sanitary and socio-economic impact of livestock diseases under diverse epidemiologic scenarios. We illustrate the applicability of this tool using foot-and-mouth disease (FMD) in Peru as an example. The approach consisted on a flexible, multistep process that may be easily adapted based on data availability. The first module (mI) uses a geo-statistical approach for the estimation (if needed) of the distribution and abundance of susceptible population (in the example here, cattle, swine, sheep, goats, and camelids) at farm-level in the region or country of interest (Peru). The second module (mII) applies SNA for evaluating the farm-to-farm contact patterns and for exploring the structure and frequency of between-farm animal movements as a proxy for potential disease introduction or spread. The third module (mIII) integrates mI-II outputs into a spatial-stochastic model that simulates within- and between-farm FMD-transmission. The economic module (mIV) connects outputs from mI-III to provide an estimate of associated direct and indirect costs. A visualization module (mV) is also implemented to graph and map the outputs of module I-IV. After 1000 simulated epidemics, the mean (95% probability interval) number of outbreaks, infected animals, epidemic duration, and direct costs were 37 (1, 1164), 2152 (1, 13, 250), 63 days (0, 442), and US$ 1.2 million (1072, 9.5 million), respectively. Spread of disease was primarily local (<4.5km), but geolocation and type of index farm strongly influenced the extent and spatial patterns of an epidemic. The approach is intended to support decisions in the last phase of the FMD eradication program in Peru, in particular to inform and support the implementation of risk-based surveillance and livestock insurance systems that may help to prevent and control potential FMD virus incursions into Peru.

Mathematical modeling of the growth and coarsening of ice particles in the context of high pressure shift freezing processes.

High pressure shift freezing (HPSF) has been proven more beneficial for ice crystal size and shape than traditional (at atmospheric pressure) freezing.1-3 A model for growth and coarsening of ice crystals inside a frozen food sample (either at atmospheric or high pressure) is developed, and some numerical experiments are given, with which the model is validated by using experimental data. To the best of our knowledge, this is the first model suited for freezing crystallization in the context of high pressure.

Sospecha de reacciones adversas a la vacuna triple vírica notificadas al Centro de Farmacovigilancia de la Comunidad Valenciana / Suspected adverse events to measles, mumps and rubella vaccine reported to the Community of Valencia Pharmacovigilance Centre

Introducción: El sistema de Farmacovigilancia de Medicamentos de Uso Humano constituye un importante mecanismo para el seguimiento postautorización de la seguridad de las vacunas. La vacuna triple vírica es una vacuna combinada de virus vivos atenuados de sarampión, rubéola y parotiditis. A pesar de que los episodios adversos asociados son considerados generalmente leves, la vacuna ha sido ampliamente cuestionada. Nuestro objetivo fue describir las notificaciones de sospecha de reacciones adversas relacionadas con esta vacuna, realizadas al Centro de Farmacovigilancia de la Comunidad Valenciana. Material y métodos: Estudio descriptivo a partir de los casos notificados entre el 15 de mayo de 2005 y el 15 de mayo de 2010.Tras agrupar las sospechas de reacciones adversas por criterios diagnósticos, fue realizado un análisis descriptivo de las variables. Resultados: Tras la administración de 545.830 dosis fueron notificadas 96 sospechas de reacciones adversas (1,76 notificaciones/100.000 dosis), que incluyeron un total de 181 reacciones. Las reacciones descritas con más frecuencia fueron fiebre (42,7%) e inflamación en la zona de inyección (36,5%). Fueron clasificadas como graves el 8,3% de las notificaciones. En todos los casos la recuperación fue completa. Conclusiones: Las sospechas de reacciones adversas notificadas coinciden con las reacciones descritas en las fichas técnicas de las vacunas. La frecuencia de notificaciones es notablemente inferior a la descrita en la literatura, no obstante, a pesar de las probables limitaciones y con los datos obtenidos podemos afirmar que la vacuna triple vírica ofrece un buen perfil de seguridad, acorde con los datos publicados hasta ahora (AU)

Introduction: A Pharmacovigilance system is an important tool for post-marketing monitoring on vaccine safety. Measles, mumps, rubella (MMR) vaccine is a combined vaccine of live attenuated virus. Since its approval, and although the adverse events are considered generally mild, the vaccine has been widely questioned for the controversies arising around its safety. Our objective was to describe suspected adverse events related to MMR vaccine reported to the Valencian Pharmacovigilance Centre. Material and methods: Descriptive study from cases reported between May 15th, 2005 and May 15th, 2010. After grouping the suspected adverse events by diagnostic criteria, a descriptive analysis of variables was performed. Results: After 545,830 doses administered, 96 notifications were reported (1.76 notifications/100,000 doses) including 181 adverse events. Fever (42.7%) and local inflammation (36.5%) were the most reported events. There were 8.3% notifications classified as severe. Recovery was complete in all cases. Conclusions: The suspected adverse events reported coincided with those described in the Summary of Product Characteristics of the vaccine. The frequency of reports was lower than previously published estimates. Despite the limitations, the data obtained allowed us to conclude that MMR vaccine has a good safety profile, according to previously published studies (AU)

[Suspected adverse events to measles, mumps and rubella vaccine reported to the Community of Valencia Pharmacovigilance Centre]. / Sospecha de reacciones adversas a la vacuna triple vírica notificadas al Centro de Farmacovigilancia de la Comunidad Valenciana.

INTRODUCTION: A Pharmacovigilance system is an important tool for post-marketing monitoring on vaccine safety. Measles, mumps, rubella (MMR) vaccine is a combined vaccine of live attenuated virus. Since its approval, and although the adverse events are considered generally mild, the vaccine has been widely questioned for the controversies arising around its safety. Our objective was to describe suspected adverse events related to MMR vaccine reported to the Valencian Pharmacovigilance Centre. MATERIAL AND METHODS: Descriptive study from cases reported between May 15th, 2005 and May 15th, 2010. After grouping the suspected adverse events by diagnostic criteria, a descriptive analysis of variables was performed. RESULTS: After 545,830 doses administered, 96 notifications were reported (1.76 notifications/100,000 doses) including 181 adverse events. Fever (42.7%) and local inflammation (36.5%) were the most reported events. There were 8.3% notifications classified as severe. Recovery was complete in all cases. CONCLUSIONS: The suspected adverse events reported coincided with those described in the Summary of Product Characteristics of the vaccine. The frequency of reports was lower than previously published estimates. Despite the limitations, the data obtained allowed us to conclude that MMR vaccine has a good safety profile, according to previously published studies.