Lack of changes in preterm delivery and stillbirths during COVID-19 lockdown in a European region.

Preliminary data in Europe have suggested a reduction in prematurity rates during the COVID-19 pandemic, implying that contingency measures could have an impact on prematurity rates. We designed a population-based prevalence proportion study to explore the potential link between national lockdown measures and a change in preterm births and stillbirths. Adjusted multivariate analyses did not show any decrease in preterm proportions during the lockdown period with respect to the whole prelockdown period or to the prelockdown comparison periods (2015-2019): 6.5% (95%CI 5.6-7.4), 6.6% (95%CI 6.5-6.8), and 6.2% (95%CI 5.7-6.7), respectively. Proportions of preterm live births did not change during lockdown when different gestational age categories were analyzed, nor when birthweight categories were considered. No differences in stillbirth rates among the different study periods were found: 0.33% (95%CI 0.04-0.61) during the lockdown period vs. 0.34% (95%CI 0.22-0.46) during the prelockdown comparison period (2015-2019).Conclusion: We did not find any link between prematurity and lockdown, nor between stillbirths and lockdown. Collaborative efforts are desirable to gather more data and additional evidence on this global health issue. What is Known: • Prematurity is associated with increased risk of morbidity and mortality. • Contingency measures during the COVID-19 pandemic may have an impact on reducing prematurity rates. What is New: • Prematurity and stillbirth rates remained stable in Castilla-y-León, a Spanish region, during COVID-19 lockdown. • The role of behavioral patterns and sociocultural factors in the prevention of preterm birth as a result of lockdown measures remains a subject for debate.

Resonance Microwave Measurements of an Intrinsic Spin-Orbit Coupling Gap in Graphene: A Possible Indication of a Topological State.

In 2005, Kane and Mele [Phys. Rev. Lett. 95, 226801 (2005)PRLTAO0031-900710.1103/PhysRevLett.95.226801] predicted that at sufficiently low energy, graphene exhibits a topological state of matter with an energy gap generated by the atomic spin-orbit interaction. However, this intrinsic gap has not been measured to this date. In this Letter, we exploit the chirality of the low-energy states to resolve this gap. We probe the spin states experimentally by employing low temperature microwave excitation in a resistively detected electron-spin resonance on graphene. The structure of the topological bands is reflected in our transport experiments, where our numerical models allow us to identify the resonance signatures. We determine the intrinsic spin-orbit bulk gap to be exactly 42.2 µeV. Electron-spin resonance experiments can reveal the competition between the intrinsic spin-orbit coupling and classical Zeeman energy that arises at low magnetic fields and demonstrate that graphene remains to be a material with surprising properties.

Impact of Specific Training in Anaphylaxis for Triage Nursing Staff in the Pediatric Emergency Department of a Tertiary Hospital.

BACKGROUND: After a diagnosis of anaphylaxis, patients receive action management plans to prevent and treat new episodes, including attending the emergency department for follow-up or further treatment. In a previous study, we observed that more than half of the children with anaphylaxis were incorrectly prioritized in our Pediatric Emergency Unit (PEU), thus delaying their treatment. In conjunction with our PEU staff, we designed a basic educational intervention (BEI) to try to solve this problem. We analyzed the effect of the intervention on triage of children subsequently diagnosed with anaphylaxis. METHODS: Our BEI consisted of a training lecture given to the PEU triage nurses and the design of a reference card highlighting symptoms and risk factors of anaphylaxis. We included 138 children with a medical diagnosis of anaphylaxis and assessed modifications in their triage priority level and waiting times (WT) before seeing a physician after our intervention. According to the BEI implementation date, 69 children were diagnosed before the intervention (G1) and 69 after (G2). Clinical data were compared to assess the severity of the episodes. RESULTS: There were no differences between the groups. WT decreased (from 8 to 1 minute; P=.03), and the number of correctly identified patients increased after the BEI (36.2% [G1] and 72.2% [G2]; P=.0001). CONCLUSIONS: Our BEI was effective, improving the identification and prioritization of children with anaphylaxis and reducing their WT. We need to pay attention to the functioning of our patients' reference emergency department and establish interdisciplinary measures that enable optimal management of anaphylaxis.

Acute and chronic stress increase salivary cortisol: a study in the real-life setting of a national examination undertaken by medical graduates.

Spanish medical graduates who apply for a medical specialty training position (MIR) must take an examination that will shape their future personal and professional lives. Preparation for the test represents an important stressor that persists for several months. The aim of this study was to elucidate the stress pattern of this group and evaluate possible changes in the circadian rhythm of cortisol release in medical graduates preparing for this test. A repeated-measures longitudinal study was performed, measuring the salivary cortisol concentrations in 36 medical graduates (13 males and 23 females; mean age of 24.2 years) on five sampling days. Five cortisol samples were collected from 07:00 to 21:00 h in order to monitor changes in the circadian rhythm. On all sampling days (except on the day of the official examination), anxiety and psychological stress were evaluated with the Spanish versions of the State-Trait Anxiety Inventory (STAI) and the Perceived Stress Scale (PSS). During the study period, participants showed higher levels of anxiety than the Spanish reference population as well as a progressive increase in self-perceived stress. A significant increase in salivary cortisol concentration was observed in both chronic (study and examination preparation) and acute (examinations) situations. Our results suggest that the cortisol awakening response (CAR) may be a good indicator of anticipatory stress but is unaffected by long-term examination preparation. Comparison of results between the official examination day and the mock examination days yielded evidence that learning may modulate the behavior of the hypothalamic-pituitary-adrenal axis.

'Indeterminate for malignancy' (Tir3/Thy3 in the Italian and British systems for classification) thyroid fine needle aspiration (FNA) cytology reporting: morphological criteria and clinical impact.

BACKGROUND: The British system (Thy1-5), the Bethesda system for reporting thyroid cytopathology (BSRTC) and the Italian Society of Anatomic Pathology and Cytology (SIAPEC) classification represent the most important international classifications for thyroid cytopathology. Irrespective of the system used, the 'indeterminate' categories are still debated among cytopathologists, particularly with regard to diagnostic criteria, clinical impact of subclassification and role of molecular techniques. AIM: We aimed to find answers to the following questions: Are there shared criteria in cytological preparations that allow the division of indeterminate follicular lesions into subcategories? What is the true clinical impact of this possible subclassification? METHODS: Among 1150 consecutive thyroid fine needle aspiration (FNA) specimens, 80 patients had nodules with a final cytological report of Tir3 (SIAPEC)/Thy3. These 80 cases were re-evaluated and subclassified according to morphological criteria into three groups: pure follicular proliferations, Hürthle cell follicular lesions and atypical proliferations. RESULTS: Sixteen (20%) cases were categorized as pure follicular proliferations, 40 (50%) as Hürthle cell follicular lesions and 24 (30%) as atypical proliferations. Surgery was performed in 57 cases (71%). Cyto-histological correlation showed that follicular adenoma was the most frequent final diagnosis in the cases treated by surgery (24/57, 42%). The overall malignancy rate in the Tir3 category was 28% (16/57). Atypical proliferations were more often malignant than either of the follicular groups (53% versus 19%, P = 0.019). CONCLUSIONS: A five-tiered classification, subdividing the 'indeterminate for malignancy' class into 'follicular proliferations' and 'atypical lesions' could be adopted. As a result of their higher risk of malignancy, surgical management of the atypical lesions would be justified. In future, the introduction of a genetic panel might contribute to their stratification, to the determination of a more accurate risk of malignancy of the atypical lesions and to the verification of follicular proliferations that are benign.

Budget impact analysis of anakinra in the treatment of familial Mediterranean fever in Italy.

INTRODUCTION: Familial Mediterranean Fever (FMF) is a hereditary autoinflammatory disease that significantly reduces occupational productivity and quality-of-life in affected patients. Italy has an estimated FMF prevalence of 1 in 60,000 people. While colchicine is the primary treatment for FMF, biologics are administered to intolerant and non-responder patients. Anakinra and canakinumab are the only biologics approved and reimbursed for FMF in Italy. Both medicines have demonstrated efficacy in FMF patients yet differ in treatment costs. This study aimed to perform a budget impact analysis (BIA) following anakinra's reimbursement for FMF treatment, considering pharmaceutical costs from the Italian National Healthcare Service (NHS) perspective. METHODS: A 'Reference scenario' (all patients treated with canakinumab) was compared to an 'Alternative scenario', with increased anakinra market shares. The target population was estimated based on the Italian population, epidemiological and market research data. Drugs costs were estimated based on Summary of Product Characteristics and net ex-factory prices. Sensitivity analyses were implemented to test results' robustness. RESULTS: The base case analysis showed an overall cumulative expenditure of €30,586,628 for 'Reference scenario' and € 16,465,548 for 'Alternative scenario'. A cumulative savings of €14,121,080 (46.2%) was calculated over 3 years as a result of the reimbursement and increasing uptake of anakinra. The sensitivity analyses, even considering a discount of 50% for canakinumab, confirmed the base case results. CONCLUSIONS: Anakinra's introduction, in FMF treatment, provides a financially sustainable option for Italian patients, with savings increasing according to greater use of anakinra.

[Indicadores de salud perinatal en una región española entre los años 2015 y 2020.] / Perinatal health indicators in a region of Spain corresponding to the period 2015 to 2020.

OBJECTIVE: The availability in the literature of data related to perinatal variables in the Spanish population is very scarce. The aim of this study was to know the evolution of perinatal health indicators according to the risk groups of prematurity and birth weight, the proportion of multiple births, caesarean section and stillbirths. METHODS: We conducted a population-based cross-sectional study of births in eleven hospitals in Castilla y León (January 2015 to June 2020). There were 70,024 newborns from 68,769 deliveries. Jointpoint regression analysis was used to identify changes in trend over the years, and binomial logistic regression was used to adjust for the potential interaction of hospital type, sex, type of delivery and multiple births on the frequencies of prematurity and death. RESULTS: There was a 19.9% decrease in deliveries and a 42% decrease in multiple births, with no change in preterm (7.7%) and stillbirths (0.44%). The percentage of caesarean sections was 21.5% with a slight downward trend over time. Death (stillbirth) was associated with preterm multiple birth; especially with the male-male combination (p<0.05). Late preterm and early term newborns showed higher risk of death compared to term newborns: OR 7.7 (95%CI 5.6-10.7) and 2.4 (95%CI 1.6-3.6), respectively; as well as the low birth weight group (OR 17.6; 95%CI 13.9-22.2) and small for gestational age (OR 3.4; 95%CI 1.9-5.8), compared to those of adequate weight. CONCLUSIONS: Prior to the development of the COVID-19 pandemic there is a decline in births, including multiple births, with no change in stillbirths or prematurity. Late preterm and early term newborns are at increased risk of intrauterine death.

OBJETIVO: La disponibilidad en la literatura de datos relacionados con variables perinatales en la población española son muy escasos. El objetivo de este estudio fue conocer la evolución de los indicadores de salud perinatal atendiendo a los grupos de riesgo de prematuridad y de peso al nacimiento, la proporción de parto múltiple, de cesárea y de mortinatos. METODOS: Se realizó un estudio transversal poblacional de los partos en once hospitales de Castilla y León (enero de 2015 a junio de 2020). Hubo 70.024 recién nacidos (RN) procedentes de 68.769 partos. Se utilizó el análisis de regresión Jointpoint para identificar cambios en la tendencia a lo largo de los años, y la regresión logística binomial para ajustar la potencial interacción del tipo de hospital, el sexo, el tipo de parto y el parto múltiple en las frecuencias de prematuridad y de fallecimiento. RESULTADOS: Hubo un descenso de partos del 19,9% y de los múltiples del 42%, sin cambios en los RN prematuros (7,7%) ni en los mortinatos (0,44%). El porcentaje de cesáreas fue del 21,5% con una ligera tendencia temporal descendente. El fallecimiento (mortinato) se asoció al parto múltiple pretérmino; especialmente a la combinación varón-varón (p<0,05). Los RN pretérminos tardíos y términos precoces mostraron mayor riesgo de fallecer frente a los RN a término: OR 7,7 (IC95% 5,6-10,7) y 2,4 (IC95% 1,6-3,6), respectivamente; así como el grupo de bajo peso (OR 17,6; IC95% 13,9-22,2) y el pequeño para la edad gestacional (OR 3,4; IC95% 1,9-5,8), frente a los de peso adecuado. CONCLUSIONES: Previo al desarrollo de la pandemia por COVID-19 existe un descenso de la natalidad, incluidos los partos múltiples, sin cambios en los mortinatos ni en la prematuridad. Los RN pretérminos tardío y términos precoces tienen mayor riesgo de fallecer intraútero.

The PHH-1V HIPRA vaccine: a new tool in the vaccination strategy against COVID-19.

OBJECTIVE: Vaccination against SARS-CoV-2 is essential to mitigate the personal, social and global impact of the coronavirus disease (COVID-19) as we move from a pandemic to an endemic phase. Vaccines are now required that offer broad, long-lasting immunological protection from infection in addition to protection from severe illness and hospitalisation. Here we present a review of the evidence base for a new COVID-19 vaccine, PHH-1V (Bimervax®; HIPRA HUMAN HEALTH S.L.U), and the results of an expert consensus. METHODS: The expert committee consisted of Spanish experts in medicine, family medicine, paediatrics, immunology, microbiology, nursing, and veterinary medicine. Consensus was achieved using a 4-phase process consisting of a face-to-face meeting during which the scientific evidence base was reviewed, an online questionnaire to elicit opinions on the value of PHH-1V, a second face-to-face update meeting to discuss the evolution of the epidemiological situation, vaccine programmes and the scientific evidence for PHH-1V and a final face-to-face meeting at which consensus was achieved. RESULTS: The experts agreed that PHH-1V constitutes a valuable novel vaccine for the development of vaccination programmes aimed towards protecting the population from SARS-CoV-2 infection and disease. Consensus was based on evidence of broad-spectrum efficacy against established and emerging SARS-CoV-2 variants, a potent immunological response, and a good safety profile. The physicochemical properties of the PHH-1V formulation facilitate handling and storage appropriate for global uptake. CONCLUSIONS: The physicochemical properties, formulation, immunogenicity and low reactogenic profile of PHH-1V confirm the appropriateness of this new COVID-19 vaccine.

Recommendations for the prevention of healthcare-associated infections in nursing homes.

Nursing homes (NH) conceptually should look as much like a home as possible. However NH have unquestionable similarities with a nosocomium as they are places where many patients with underlying diseases and comorbidities accumulate. There is evidence of transmission of microorganisms between residents and between residents and caregivers. We have not found any recommendations specifically aimed at the prevention of nosocomial infections in NH by the major Public Health Agencies and, therefore, the Health Sciences Foundation (Fundación de Ciencias de la Salud) has convened a series of experts and 14 Spanish scientific societies to discuss recommendations that could guide NH personnel in establishing written programs for the control and reduction of these infections. The present document is the result of these deliberations and contains suggestions for establishing such control programs on a voluntary and flexible basis in NH. We also hope that the document can help the health authorities to encourage this control activity in the different territorial areas of Spain. In our opinion, it is necessary to draw up a written plan and establish the figure of a coordinator or person responsible for implementing these projects. The document includes measures to be implemented and ways of quantifying the reality of different problems and of monitoring the impact of the measures established.

Dihydroceramide- and ceramide-profiling provides insights into human cardiometabolic disease etiology.

Metabolic alterations precede cardiometabolic disease onset. Here we present ceramide- and dihydroceramide-profiling data from a nested case-cohort (type 2 diabetes [T2D, n = 775]; cardiovascular disease [CVD, n = 551]; random subcohort [n = 1137]) in the prospective EPIC-Potsdam study. We apply the novel NetCoupler-algorithm to link a data-driven (dihydro)ceramide network to T2D and CVD risk. Controlling for confounding by other (dihydro)ceramides, ceramides C18:0 and C22:0 and dihydroceramides C20:0 and C22:2 are associated with higher and ceramide C20:0 and dihydroceramide C26:1 with lower T2D risk. Ceramide C16:0 and dihydroceramide C22:2 are associated with higher CVD risk. Genome-wide association studies and Mendelian randomization analyses support a role of ceramide C22:0 in T2D etiology. Our results also suggest that (dh)ceramides partly mediate the putative adverse effect of high red meat consumption and benefits of coffee consumption on T2D risk. Thus, (dihydro)ceramides may play a critical role in linking genetic predisposition and dietary habits to cardiometabolic disease risk.

Consensus statement on the use of alemtuzumab in daily clinical practice in Spain. / Consenso de expertos sobre el uso de alemtuzumab en la práctica clínica diaria en España.

INTRODUCTION: Alemtuzumab is a highly effective drug approved by the European Medicines Agency as a disease-modifying drug for the treatment of relapsing-remitting multiple sclerosis. OBJECTIVE: A consensus document was drafted on the management of alemtuzumab in routine clinical practice in Spain. DEVELOPMENT: A group of multiple sclerosis specialists reviewed articles addressing treatment with alemtuzumab in patients with multiple sclerosis and published before December 2017. The included studies assessed the drug's efficacy, effectiveness, and safety; screening for infections and vaccination; and administration and monitoring aspects. The initial proposed recommendations were developed by a coordinating group and based on the available evidence and their clinical experience. The consensus process was carried out in 2 stages, with the initial threshold percentage for group agreement established at 80%. The final document with all the recommendations agreed by the working group was submitted for external review and the comments received were considered by the coordinating group. CONCLUSION: The present document is intended to be used as a tool for optimising the management of alemtuzumab in routine clinical practice.

Consensus statement on the use of alemtuzumab in daily clinical practice in Spain.

INTRODUCTION: Alemtuzumab is a highly effective drug approved by the European Medicines Agency as a disease-modifying drug for the treatment of relapsing-remitting multiple sclerosis. OBJECTIVE: A consensus document was drafted on the management of alemtuzumab in routine clinical practice in Spain. DEVELOPMENT: A group of multiple sclerosis specialists reviewed articles addressing treatment with alemtuzumab in patients with multiple sclerosis and published before December 2017. The included studies assessed the drug's efficacy, effectiveness, and safety; screening for infections and vaccination; and administration and monitoring aspects. The initial proposed recommendations were developed by a coordinating group and based on the available evidence and their clinical experience. The consensus process was carried out in 2 stages, with the initial threshold percentage for group agreement established at 80%. The final document with all the recommendations agreed by the working group was submitted for external review and the comments received were considered by the coordinating group. CONCLUSION: The present document is intended to be used as a tool for optimising the management of alemtuzumab in routine clinical practice.

[Vaccination against community acquired pneumonia in adults. Update 2021 of the position paper by Neumoexpertos en Prevención Group]. / Vacunación frente a la neumonía adquirida en la comunidad del adulto. Actualización 2021 del posicionamiento del Grupo de Neumoexpertos en Prevención.

Community-acquired pneumonia (CAP) continues to be an important cause of morbidity and mortality in adults. The aim of this study is to update the practical prevention guide for CAP through vaccination in Spain developed in 2016 and updated in 2018, based on available vaccines and evidence through bibliographic review and expert opinion. The arrival of COVID-19 as a new cause of CAP and the recent availability of safe and effective vaccines constitutes the most significant change. Vaccines against pneumococcus, influenza, pertussis and COVID-19 can help to reduce the burden of disease from CAP and its associated complications. The available evidence supports the priority indications established in this guide, and it would be advisable to try to achieve a widespread dissemination and implementation of these recommendations in routine clinical practice.

Comparison of knowledge, attitudes and hand hygiene behavioral intention in medical and nursing students.

INTRODUCTION: Hand hygiene is crucial to prevent cross infection. Healthcare students are in a prime position to learn hand hygiene skills. The aim of this study was to analyze hand hygiene behavioral intentions of healthcare students before and after contact with the patient and to compare the knowledge of and attitude towards hand hygiene between medical and nursing students. METHODS: In a descriptive survey research design, convenience selection of a sample of medical students (n=657) and nursing students (n=303) was done from modules taught by the Department of Preventive Medicine and Public Health in both Medicine and Nursing undergraduate degrees in four Spanish universities. The hand hygiene Questionnaire, a validated instrument to evaluate behavior, knowledge, and attitudes, was used. RESULTS: A significantly lower percentage of students reported always or almost always carrying out hand hygiene before contact with the patient or invasive procedures in comparison to the percentage complying after contact with secretions or with the patient. Although hand hygiene knowledge appears acceptable, its importance is not sufficiently valued. CONCLUSIONS: There are deficiencies in behavioral intention, knowledge, and attitudes related to hand hygiene in medical and nursing students. Better results are observed among nursing students, especially those who have received specific training.

[Recovering lost vaccine coverage due to COVID-19 pandemic]. / Recuperando las coberturas vacunales perdidas en la pandemia de COVID-19.

The 2019 coronavirus disease pandemic can have an alarming impact on vaccination coverage. WHO, UNICEF and Gavi warn that at least 80 million children under the age of 1 are at risk of contracting diseases such as diphtheria, measles and polio due to the interruption of routine immunization and the temporary suspension of 93 campaigns of large-scale vaccination.In Spain, a new healthcare scenario, which prioritizes telematics over in person, fear of contagion by going to health centers, and recommendations for physical distance and restricted mobility, reduce attendance at primary care centers. Despite recommendations established by the health authorities, vaccination coverage has decreased in all Autonomous Communities between 5% and 60%, depending on the age and type of vaccine. School vaccinations have been suspended and only vaccination of pregnant women against tetanus, diphtheria and pertussis has been maintained. The decrease has been more evident for non gratuity vaccines: the first dose of meningococcal vaccine B has decreased by 68.4% in the Valencian Community, and Andalusia has observed a 39% decrease in the total doses of this vaccine and of 18% for that of rotavirus.The recovering of vaccinations should be planned, organized and carried out in the shortest possible time.This article discusses some aspects of the recovery of vaccination coverage for different groups: children, adolescents and adults, and patients at risk and in special situations.

Micelle formation between 5-hydroxytryptamine and adenosine triphosphate in platelet storage organelles.

As judged by analytical ultracentrifugation, 5-hydroxytryptamine and adenosine-5'-triphosphate form micelles in artificial mixtures and also in storage organelles containing 5-hydroxytryptamine of blood platelets of rabbits. Their average apparent molecular weights depend on the concentration and on the molar ratio of the two constituents. The 5-hydroxytryptamine and adenosine triphosphate of these 5-hydroxytryptamine organelles may be stored in vivo together as micelles with apparent molecular weights of several hundred thousands or more.

The immune response evokes changes in brain noradrenergic neurons.

A decreased noradrenaline turnover in the hypothalami of rats was observed at the peak of the immune response to sheep red blood cells. The decrease in noradrenergic neuronal activity was mimicked by injection of soluble r mediators released by immunological cells activated in vitro. Noradrenaline also tended to decrease in the brainstem but not in the residual brain. It is suggested that products released from activated immunological cells during the immune response may induce the previously described autonomic and endocrine mechanisms that contribute to immunoregulation.

[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.