[Vaccine-related adverse reactions in immunocompromised patients and in special situations of a hospital Vaccine Unit]. / Reacciones adversas asociadas a la vacunación en pacientes inmunodeprimidos y en situaciones especiales de una Unidad de Vacunas hospitalaria.

OBJECTIVE: The aim of the study was to describe the type of vaccines administered in the Vaccine Unit at a reference hospital. Calculate the overall and specific reporting rate of adverse reactions. METHODS: Retrospective observational study for the period between November 2014 and November 2017, on patients who developed an adverse drug reaction (ADR) after the administration of a vaccine and who were notified to the Spanish Pharmacovigilance System. The variables analyzed were age, sex, risk group, vaccine class, co-administration and type of ADR. A univariate and bivariate analysis was performed. The global and vaccine specific rate of ADR notification was calculated. RESULTS: A total of 18,123 vaccines were administered, of which 20.7% corresponded to hepatitis B virus vaccine. Fifty-three RAM suspects were reported. In 64.2% of cases only one vaccine was administered. Inactivated vaccines accounted for 88.7% of notifications. The highest number of notifications was generated by the 23 serotypes pneumococcal polysaccharide vaccine. The overall reporting rate was 0.42%. The hexavalent vaccine had the highest reporting rate (2.81%). 49.1% of the ADR were systemic. CONCLUSIONS: The overall reporting rate was low but higher than that of other authors. Proper reporting of possible adverse post-vaccine reactions is essential to contribute to vaccine safety and to increase public confidence in vaccines.

[Bronchospasm and flushing after vaccination with 23 serotype pneumococcal polysaccharide in chronic patients]. / Broncoespasmo y flushing tras la vacunación con neumococo polisacárida de 23 serotipos en pacientes crónicos.

OBJECTIVE: To describe the clinical-epidemiological characteristics of a series of suspected systemic adverse reactions registered with the 23 serotype pneumococcal polysaccharide vaccine (PNEUMOVAX23®). Calculate the cumulative incidence of the reaction and know if similar and/or compatible cases have been described in the scientific literature or in pharmacovigilance. METHODS: Observational and retrospective study realized between 01/12/2015 and 30/09/2017 in the Vaccines Unit of an autonomic reference hospital. We calculated the cumulative incidence of the adverse reaction for that vaccine. The common pharmacovigilance database (FEDRA) was consulted. RESULTS: Nine systemic adverse reactions were recorded (flushing + bronchospasm + SatO2<95%). The cumulative incidence was 1.036%. The outcome was recovered/resolved for everyone. No similar and/or compatible cases were found. CONCLUSIONS: The reactions described do not appear in the PNEUMOVAX23® data sheet. Epidemiologically, no causal relationship can be established between the symptoms and the variables studied. This study could be the basis for more detailed research that could modify the vaccine data sheet.

[Use of hepatitis B AS04C adjuvanted vaccine in HIV patients]. / Uso de vacuna frente a hepatitis B adyuvada con AS04C en pacientes VIH.

OBJECTIVE: Co-infection with hepatitis B virus (HBV) in patients with human immunodeficiency virus (HIV) increases associated morbidity and mortality. Vaccination against HBV has been shown to be the most effective method to prevent this situation. Standard vaccination schemes used in this population do not appear to be effective enough. The objective is to identify the response rate following the use of AS04C-adjuvanted hepatitis B vaccine in HIV patients as well as the possible associated adverse reactions. METHODS: An observational, analytical study with a retrospective cohort of HIV positive patients discharged in 2016 from the Vaccines Unit of a Preventive Medicine and Public Health Service. Patients with antiHBs (-), antiHBcActot (-) and HBsAg (-) at baseline were included, none of them had received prior HBV vaccination. HBV adjuvanted vaccine was used in a 4-dose regimen (0-1-2-6 months). When antiHBs was <10 IU/mL after primovaccination, two additional doses of the same vaccine were applied with an interval of 30 days. RESULTS: A total of 39 patients were included. Of them, 74.4% were men. The mean age was 47.26 years. The response rate after primary vaccination was higher than 92% and up to 100% with the two subsequent doses. No adverse reactions were reported. CONCLUSIONS: The administration of AS04C-adjuvanted hepatitis B vaccine in HIV patients showed a 100% response rate, showing an excellent safety profile.

[The short-term effects of air pollution on mortality: the results of the EMECAM project in 2 cities of Asturias. Estudio Multicéntrico Español sobre la Relación entre la Contaminación Atmosférica y la Mortalidad]. / Efectos a corto plazo de la contaminación atmosférica sobre la mortalidad: resultados del proyecto EMECAM en dos ciudades de Asturias.

BACKGROUND: The studies conducted to date regarding the possibility that air pollutants, at levels considered safe to date, are capable of having impact are capable of having impact on human health have not led to homogeneous findings. This study is aimed at estimating the degrees of relationship between the daily levels of the pollutants and the death rate on a short-terms basis in the two most populated cities in Austria (Gijón and Oviedo), as well as contributing to increasing the statistical importance and the representative nature of the EMECAM Project, within which this study is comprised. METHODS: Ecological time series study, Estimate of degrees of group exposure based on the readings taken at the pollution control stations. Modeling of the death rate series, including control variables, by means of Poisson regression. Estimating risks related to each pollutant for the death rate, controlling the series-based autocorrelation. RESULTS: Throughout the 1993-1996 period, the pollution by means of particles in suspension and CO was greater in Gijón, that involving SO2 and NO2 having been greater in Oviedo. In these two cities, the levels can be considered to be low and to fall within what is considered admissible under the laws currently in impact. Most of the relative risk forecasts neared the zero impact point, although significant positive (especially for NO2) as well as negative relationships have been found to exist. The significant relationships found were not proven to be consistent in these two cities for the periods studied. CONCLUSIONS: Based on the findings of this study, the conclusion cannot be drawn that a clear-cut relationship exists between the pollutants studied (particles, SO2, NO2, CO) and the death rate on a short-term basis, at least at the levels detected in Gijón and Oviedo.