Challenges to agile software project management practices in the context of the COVID-19 pandemic

The Agile approach is focused on individuals and customer satisfaction, based on the dynamic and streamlined work of a team that is capable of adapting, and adapting the project to changing scenarios and demands. However, amidst the COVID-19 pandemic, Agile teams accustomed to in-person communication have encountered the challenges of working from home. The main objective of this research is to analyze the challenges generated by the pandemic context, and the consequent social distance, for the development of software projects that use Agile approaches within a large state-owned company and identify the effect it had on the course and results of the projects. The research was qualitative in nature and had two exploratory diagnostic stages. The findings indicate that there were no negative impacts of relevance on project deliveries. On the one hand, results indicated losses in socialization, in spontaneous exchanges of knowledge, and in interaction among teams, as well as a demand for greater engagement of professionals. Additionally, limitations were revealed for more complex discussions and knowledge management. The study highlights solutions that were found and/or suggested for many challenges, contributing to the literature on best practices for the Agile approach, and is focused on the unprecedented context of the COVID-19 pandemic. Our findings can contribute to other companies with a similar profile that work with Agile projects, besides contributing to building a dialogue between the academic and business environments. © 2023 Brazilian Institute for Information in Science and Technology. All rights reserved.

Who is who in fact-checked conspiracy theories? Disseminators, sources, and the struggle for authority in polarized environments

Despite the growing scholarship concerning mis- and disinformation, research has yet to assess how journalism tackles conspiracy theories in settings where news organizations and media professionals have their authority questioned. Against this background, our article poses two research questions: RQ1) Who are the actors mainstream fact-checkers cover when addressing conspiracy theories? RQ2) To what extent does the focus on such actors delegitimize those who challenge news organizations or compete with them for the audience? Using content analysis as our key methodological strategy, we consider 197 fact-checks published between 2018 and 2021 by the Projeto Comprova, a Brazilian initiative currently comprising professionals from 41 media organizations. We found that the most discussed topics were those mobilizing polarized groups, namely, the Covid-19 pandemic and election fraud allegations. The then-President Bolsonaro and his supporters were often cited as disseminators of such plots. In turn, Facebook is pointed out as a thriving environment for the circulation of conspiratorial narratives. The results also reveal the prominence of mainstream news outlets as sources to ground the "factual” information sustained in the fact-checks. More interestingly, our data suggest that fact-checkers have favored specific news values when addressing conspiracy theories. To strengthen our investigation, we use interviews with four professionals contributing to the Comprova to illustrate how the project has brought together rival companies interested in delegitimizing "alternative” sources of information. © The Author(s) 2023.

Terapia De Segunda Linha Com Eltrombopague Em Pacientes Adultos Com Trombocitopenia Imune: Experiencia De Um Hospital Publico Brasileiro

Objetivo: Descrever os resultados de uma serie de pacientes com Purpura Trombocitopenica Imune (PTI) tratados com eltrombopague. Materiais e metodos: Estudo observacional retrospectivo atraves da analise dos prontuarios digitais de pacientes adultos atendidos no Hospital de Transplantes Euryclides de Jesus Zerbini-Hospital Brigadeiro. Criterios de inclusao: 1) pacientes adultos com diagnostico de PTI;2) historico de tratamento com eltrombopague como terapia de segunda linha (ou linha posterior). A resposta foi definida como contagem de plaquetas sustentada >=30.000/mm3 (remissao:>= 100.000/mm3 e resposta parcial: 30.000 - 100.000/mm3). Resultados/Discussao: Entre marco de 2014 e julho de 2022, 42 pacientes utilizaram eltrombopague. A mediana de idade no inicio do tratamento foi de 55 anos(variacao:18-78) e 65% eram do sexo feminino. Distribuicao dos pacientes quanto ao numero de tratamentos anteriores: 4 pacientes-1 linha previa, 13 pacientes-2 linhas previas, 14 pacientes-3 linhas previas, 11 pacientes- 4 ou mais linhas previas. Todos receberam eltrombopague apos um ano do diagnostico de PTI (fase cronica). Dez pacientes (24%) eram esplenectomizados. A maioria recebeu tratamento associado por algum periodo (59% com corticoide, 1% com imunoglobulina e 17% com corticoide e imunoglobulina). Ao todo, 38 pacientes (90%) obtiveram alguma resposta - 4 (10%) obtiveram resposta completa e 34 (21%) obtiveram resposta parcial. Dos pacientes que obtiveram resposta parcial, 8 pacientes (19%) perderam resposta. A mediana de tempo para resposta foi de 2 semanas (variacao:1-16). A dose utilizada para obtencao de resposta foi 25 mg para 5 pacientes (13%), 50 mg para 19 pacientes (50%) e 75 mg para 14 pacientes (37%). A maioria necessitou mudanca na dose durante o periodo de tratamento. A mediana de tempo de duracao da resposta foi de 22 meses (variacao:3-59). Uma paciente evoluiu para obito durante uso da medicacao, mas de causa nao-relacionada ao tratamento (coronavirus). Em relacao aos eventos adversos, 25 pacientes (60%) apresentaram sangramento (3 pacientes- grau 2 do escore de sangramento para PTI), 2 pacientes (5%) apresentaram tromboembolismo venoso, 1 paciente (2%) apresentou alteracao hepatica e 1 paciente (2%) apresentou fibrose de medula ossea. Portanto, mesmo com alta taxa de eventos adversos no geral (70%), apenas 17% foram eventos clinicamente mais significativos. As taxas de tromboembolismo, toxicidade hepatica e fibrose de medula ossea estao abaixo das reportadas na literatura em estudos previos. Tres pacientes (7%) descontinuaram o uso por eventos adversos e 3 (7%) por decisao propria. A mediana de seguimento foi de 28 meses (variacao:2-78). Dois pacientes (5%) perderam o seguimento. Conclusao: Neste cenario clinico, o tratamento a longo prazo com eltrombopague foi geralmente seguro, bem tolerado e eficaz, mesmo com uma quantidade significativa de pacientes com varias linhas de tratamento previas. Copyright © 2022

Remissao Espontanea De Leucemia Mieloide Aguda Apos Infeccao Grave Por Covid-19 E Choque Septico: Relato De Caso

Introducao: A remissao espontanea de leucemia mieloide aguda e um evento muito raro, e suas descricoes na literatura medica geralmente envolvem um evento infeccioso grave. Mais recentemente, a COVID-19 tambem foi descrita como um dos fatores associados a tal fenomeno, e a hipotese mais aceita para o mesmo e de que ha uma hiperativacao imune que tambem apresenta efeito antitumoral. Relato de caso: Paciente feminina, de 54 anos, foi admitida no Hospital Brigadeiro com historia de alteracao de nivel de consciencia e lesao em pododactilo direito que motivou a procura do pronto socorro. No hemograma da admissao, apresentava hemoglobina 8,2 g/dL VCM 87, plaquetometria 11.000/mm3, leucocitos 99560 com 88% de celulas de medio a grande tamanho, alta relacao nucleo citoplasma nucleolos evidentes e presenca frequente de bastonete de Auer. A imunofenotipagem de sangue periferico,22,4% destas celulas revelaram marcacao CD13, CD15++, CD33++/+++, CD34 par, CD38+++, CD64+, CD71+, CD117, CD123+, HLA-DR, MPO par, alem de 18,6% de monocitos maduros, com diagnostico de leucemia mieloide aguda. Foi colhido teste rapido para COVID-19 antes da internacao, com resultado positivo. Nos 3 dias que se seguiram, a paciente evoluiu com desconforto respiratorio, taquipneia, e a tomografia de torax revelou ainda broncopneumonia sobreposta a COVID-19, o que resultou em intubacao orotraqueal por insuficiencia respiratoria. Durante a intubacao, a paciente evoluiu com parada cardiorrespiratoria em atividade eletrica sem pulso, com retorno a circulacao espontanea apos 10 minutos. Dada a gravidade do quadro, foi optado por nao iniciar inducao quimioterapica. Ao longo da internacao em UTI, a paciente fez uso de piperacilina tazobactam com vancomicina nos primeiro 7 dias de internacao, teve Pseudomonas aeruginosa multissensivel isolada de aspirado traqueal, e recebeu meropenem e teicoplanina por novo evento de choque septico, por 7 dias. Sua internacao em UTI durou 41 dias, contudo, ao longo dos primeiros 30 dias de internacao houve clareamento de blastos em sangue periferico, e parametros como hemoglobina e plaquetometria tambem evoluiram com melhora. Ao final do 42degree dia, quando recebeu alta da UTI para a enfermaria, foi feita avaliacao medular, quel nao revelou blastos com as caracteristicas imunofenotipicas previamente descritas. A paciente se encontra atualmente internada e com remissao citomorfologica e sem doenca residual minima pela imunofenotipagem. Nao foi administrada qualquer terapia antineoplasica, somente hidroxiureia para fins de citorreducao, nos primeiros 7 dias do quadro. Discussao: O caso evidencia uma rara e ainda nao compreendida remissao de leucemia mieloide aguda apos infeccao por COVID-19 e complicacoes infecciosas bacterianas graves. Casos semelhantes ja foram descritos em sepse grave e COVID-19 isoladamente, mas a evolucao natural do quadro envolve a recaida da doenca apos alguns meses do quadro agudo. A terapia antineoplasica, por sua vez, e indispensavel para a remissao sustentada. A explicacao mais aceita para o fenomeno e de que um mecanismo imunologico ativado e producao excessiva de citocinas pro-inflamatorias, sobretudo na COVID-19, destruiria as celulas neoplasicas, que poderiam inclusive ser infectadas pelo virus. Conclusao: Apesar de o mecanismo exato da remissao ser desconhecido, o caso apresentado reforca o papel da imunidade do individuo no tratamento antineoplasico e justifica a imersao em mais estudos envolvendo imunoterapia para a leucemia mieloide aguda. Copyright © 2022

Adverse Reactions Associated with Comirnaty Among Healthcare Professionals: A Cohort Event Monitoring Study in a Portuguese Hospital

Introduction: The Portuguese government put into practice a vaccination plan soon after the approval of the first COVID-19 vaccine, prioritizing healthcare professionals (HCPs) and other population groups at risk. Objective(s): To characterize the case reports of adverse drug reactions (ADRs) associated with the administration of Comirnaty to HCPs in a Portuguese oncology hospital (IPO Coimbra). Method(s): This study was a nine-month prospective, observational study following a cohort event monitoring approach focused on signalling ADRs associated with the administration of Comirnaty to HCP in IPO Coimbra. The case reports of ADRs were sent to the Pharmacovigilance Unit of Coimbra (UFC) between 14/01/2021 and 13/10/2021. The population of HCP was characterized according to gender and age distribution. The seriousness of ADRs was assessed for each individual case in accordance with WHO criteria [1]. ADRs were coded with MedDRA version 24.0 (System Organ Classification [SOC] and Preferred Term [PT]). ADRs were classified as ''expected'' or ''unexpected'' according to their description in the Summary of Product Characteristics (SmPC) of Comirnaty [2]. Result(s): A total of 816 HCPs were inoculated with at least one dose of Comirnaty-. The case reports of ADRs concerned 469 (57.5%) HCPs: 386 (82.3%) females;642 (78.7%) aged 30-59 years old. Of the 469 case reports, 24 (5%) were assessed as serious, 44 (9.4%) as unexpected, and 11 (2.3%) as both serious and unexpected. The 469 case reports contained a total of 1,955 ADRs. ''General disorders and administration site condition'' (n = 1,075;54,9%), such as vaccination site pain, chills and vaccination site swelling;''Musculoskeletal and connective tissue disorders'' (n = 373;19.1%), including myalgia and arthralgia;and ''Nervous system disorders'' (n = 250;12.8%), including headache, were the most frequently reported ADRs, which is in line with the SmPC of Comirnaty-. The 11 case reports classified as both serious and unexpected contained a total of 17 ADRs, including hyperhidrosis and paraesthesia. Conclusion(s): The results of this study bring value to the characterization of the safety profile of Comirnaty since the use of a cohort of individuals allows to estimate frequencies of ADRs in the real-world. Further, serious, and unexpected ADRs were identified. Importantly, this type of safety data was further included in the SmPC of the vaccine. In conclusion, the results are in favour of the positive benefitrisk ratio of Comirnaty-, and reinforce the importance of post-marketing pharmacovigilance to increase knowledge on drug safety.

The Impact of the COVID-19 Pandemic on Spontaneous Reporting of Adverse Drug Reactions in the Central Region of Portugal

Introduction: The COVID-19 pandemic has had an impact on several sectors of the society. Whether it has disrupted drug safety monitoring is yet to be determined. Objective(s): To investigate whether the COVID-19 pandemic has had an impact on the proportions of spontaneous reports (SRs) of serious and unexpected adverse drug reactions (ADRs). Method(s): SRs received by the Coimbra Pharmacovigilance Unit (UFC) between January 2017 and December 2021 were included, except for those containing COVID-19 vaccines as suspected medicines. The SRs were categorized into two groups: pre-pandemic (2017-2019);and post-pandemic (2020-2021). The SRs were classified as serious or non-serious, and expected or unexpected, depending on the seriousness and expectedness of the suspected ADRs, according to the WHO criteria and the Summary of Product Characteristics [SmPC] of each suspected medicine, respectively [1,2]. To study the impact of the COVID-19 pandemic on the patterns of spontaneous reporting of suspected ADRs, two null hypotheses were proposed to test whether (i) the seriousness, and (ii) the expectedness were independent of the pandemic (i.e., if the pandemic has had no impact, then the proportions of SRs containing (i) serious and (ii) unexpected ADRs were expected to be the same in both periods). The qui-square test was used to test the hypotheses;p-values <0.001 were considered statistically significant. Microsoft Excel was used for the statistical analyses. Result(s): A total of 1,311 and 657 SRs were received in the prepandemic and post-pandemic periods, respectively. Of the 1,311 SRs received in the three pre-pandemic years, 1,012 (77%) were serious and 657 (13%) contained unexpected ADRs;of the 657 SR received during the two post-pandemic years, 434 (66%) were serious and 133 (20%) contained unexpected ADRs. The changes from pre- to postpandemic on both proportions of SRs containing serious (an absolute decrease of 11%;p = 0.01) or unexpected ADRs (an absolute increase of 7%;p = 0.01) were not statistically significant. Conclusion(s): The COVID-19 pandemic has had not a significant impact on the proportions of SRs of serious or unexpected ADRs in the Central Region of Portugal. Further research should be carried out in other pharmacovigilance databases to understand if the present conclusions are applicable to other geographic regions.

Adverse Reactions Associated with Comirnaty® Among Healthcare Professionals: A Cohort Event Monitoring Study in a Portuguese Hospital: An International Journal of Medical Toxicology and Drug Experience

Introduction: The Portuguese government put into practice a vaccination plan soon after the approval of the first COVID-19 vaccine, prioritizing healthcare professionals (HCPs) and other population groups at risk. Objective: To characterize the case reports of adverse drug reactions (ADRs) associated with the administration of Comirnaty to HCPs in a Portuguese oncology hospital (IPO Coimbra). Methods: This study was a nine-month prospective, observational study following a cohort event monitoring approach focused on signalling ADRs associated with the administration of Comirnaty to HCP in IPO Coimbra. The case reports of ADRs were sent to the Pharmacovigilance Unit of Coimbra (UFC) between 14/01/2021 and 13/10/2021. The population of HCP was characterized according to gender and age distribution. The seriousness of ADRs was assessed for each individual case in accordance with WHO criteria [1]. ADRs were coded with MedDRA version 24.0 (System Organ Classification [SOC] and Preferred Term [PT]). ADRs were classified as expected or unexpected according to their description in the Summary of Product Characteristics (SmPC) of Comirnaty [2]. Results: A total of 816 HCPs were inoculated with at least one dose of Comirnaty. The case reports of ADRs concerned 469 (57.5%) HCPs: 386 (82.3%) females;642 (78.7%) aged 30-59 years old. Of the 469 case reports, 24 (5%) were assessed as serious, 44 (9.4%) as unexpected, and 11 (2.3%) as both serious and unexpected. The 469 case reports contained a total of 1,955 ADRs. "General disorders and administration site condition" (n = 1,075;54,9%), such as vaccination site pain, chills and vaccination site swelling;"Musculoskeletal and connective tissue disorders" (n = 373;19.1%), including myalgia and arthralgia;and "Nervous system disorders" (n = 250;12.8%), including headache, were the most frequently reported ADRs, which is in line with the SmPC of Comirnaty®. The 11 case reports classified as both serious and unexpected contained a total of 17 ADRs, including hyperhidrosis and paraesthesia. Conclusion: The results of this study bring value to the characterization of the safety profile of Comirnaty® since the use of a cohort of individuals allows to estimate frequencies of ADRs in the real-world. Further, serious, and unexpected ADRs were identified. Importantly, this type of safety data was further included in the SmPC of the vaccine. In conclusion, the results are in favour of the positive benefitrisk ratio of Comirnaty®, and reinforce the importance of post-marketing pharmacovigilance to increase knowledge on drug safety.

The Impact of the COVID-19 Pandemic on Spontaneous Reporting of Adverse Drug Reactions in the Central Region of Portugal: An International Journal of Medical Toxicology and Drug Experience

Introduction: The COVID-19 pandemic has had an impact on several sectors of the society. Whether it has disrupted drug safety monitoring is yet to be determined. Objective: To investigate whether the COVID-19 pandemic has had an impact on the proportions of spontaneous reports (SRs) of serious and unexpected adverse drug reactions (ADRs). Methods: SRs received by the Coimbra Pharmacovigilance Unit (UFC) between January 2017 and December 2021 were included, except for those containing COVID-19 vaccines as suspected medicines. The SRs were categorized into two groups: pre-pandemic (2017-2019);and post-pandemic (2020-2021). The SRs were classified as serious or non-serious, and expected or unexpected, depending on the seriousness and expectedness of the suspected ADRs, according to the WHO criteria and the Summary of Product Characteristics [SmPC] of each suspected medicine, respectively [1,2]. To study the impact of the COVID-19 pandemic on the patterns of spontaneous reporting of suspected ADRs, two null hypotheses were proposed to test whether (i) the seriousness, and (ii) the expectedness were independent of the pandemic (i.e., if the pandemic has had no impact, then the proportions of SRs containing (i) serious and (ii) unexpected ADRs were expected to be the same in both periods). The qui-square test was used to test the hypotheses;p-values < 0.001 were considered statistically significant. Microsoft Excel® was used for the statistical analyses. Results: A total of 1,311 and 657 SRs were received in the prepandemic and post-pandemic periods, respectively. Of the 1,311 SRs received in the three pre-pandemic years, 1,012 (77%) were serious and 657 (13%) contained unexpected ADRs;of the 657 SR received during the two post-pandemic years, 434 (66%) were serious and 133 (20%) contained unexpected ADRs. The changes from pre- to postpandemic on both proportions of SRs containing serious (an absolute decrease of 11%;p = 0.01) or unexpected ADRs (an absolute increase of 7%;p = 0.01) were not statistically significant. Conclusion: The COVID-19 pandemic has had not a significant impact on the proportions of SRs of serious or unexpected ADRs in the Central Region of Portugal. Further research should be carried out in other pharmacovigilance databases to understand if the present conclusions are applicable to other geographic regions.

Online Problem-Based Learning During the Pandemic: SWOT Analysis of the Nursing Student’s Opinion

Problem-based learning enables nursing students to acquire and develop the competencies necessary for professional nursing. The world pandemic COVID-19 impacted nursing education by including a transition to online and digital platforms. The SWOT analysis was used as an instrument to identify strengths and weaknesses during the period referred, for strategic management of the curriculum course Nursing Decision-Making Process (NDMP). The aim of the study was to identify the positive and negative aspects of the online problem-based learning experience with the NDMP course of the Undergraduate Nursing Program, at the Nursing School of Lisbon. It is a qualitative and exploratory study, with data collected through documental analysis of the two final evaluations of the course: the answers to the open-ended question of the individual questionnaire, and the students’ tutorial groups evaluation. The qualitative data analysis was performed according to Bardin through the webQDA software®. The study included 567 students, rom the 2020 and 2021 academic years. The results were: for the strength, the orientation and personalization teaching strategies developed during the tutorial orientation;for weaknesses, the insufficient time available for the development of the learning process;for the opportunities, the absence of travelling time home to school, enhanced learning;for the threats, the focus was on work overload which resulted from semesters adjustments. The qualitative research methodology with interpretation and comprehension for what is `said´ by the students, allowed us to identify the positive and negative aspects of online problem-based learning and delineate strategies for the future. © 2022, The Author(s), under exclusive license to Springer Nature Switzerland AG.

Knowledge Transfer and the Challenges of the Virtual World

Transferring knowledge to the clinic is a complex process and involves more than disseminating or communicating research results;it implies the planning and implementation of strategies to identify target audiences, such as clinicians, managers, policy agents, and consumers. In this reflection article, the authors aim to discuss challenges to be transferring knowledge and ‘qualitative evidence’ in the virtual world and promote the debate about strategies for disseminating qualitative research online. This text results from the dialogue between the researchers’ concerns, their experiences, and the literature on the subject. The situation caused by SARS-CoV-2 made it clear that there are clear challenges to using qualitative research methods and techniques in the online modality, from the design to the implementation of knowledge. The complexity of the processes experienced by people has increased the need for in-depth qualitative studies to make clear the influence of context, constraints and adaptations resulting from the pandemic on human existence, but also has made it clear that the methods and techniques of data collection that were traditionally developed in the field need a different methodological approach to be carried out in an online modality. On the other hand, the implementation of knowledge in clinical settings can be achieved with virtual strategies, but it also implies collaborative work between researchers and clinical professionals. We conclude that there is a need to study the use of methods and techniques traditionally used in the context for its use either in online modality or to explore the virtual world. © 2022, The Author(s), under exclusive license to Springer Nature Switzerland AG.

Infection in asymptomatic carriers of SARS-CoV-2 can interfere with the achievement of robust immunity on a population scale

The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) continues to spread worldwide as a severe pandemic, and a significant portion of the infected population may remain asymptomatic. Given this, five surveys were carried out between May and September 2020 with a total of 3585 volunteers in the municipality of Foz do Igua..u, State of Paran.., a triple border region between Brazil/Argentina/Paraguay. Five months after the first infection, volunteers were re-analysed for the production of IgG anti-Spike and anti-RBD-Spike, in addition to analyses of cellular immunity. Seroconversion rates ranged from 4.4% to a peak of 37.21% followed by a reduction in seroconversion to 21.1% in September, indicating that 25% of the population lost their circulating anti-SARS-CoV-2 antibodies 3 months after infection. Analyses after 5 months of infection showed that only 17.2% of people still had anti-RBD-Spike antibodies, however, most volunteers had some degree of cellular immune response. The strategy of letting people become naturally infected with SARS-CoV-2 to achieve herd immunity is flawed, and the first contact with the virus may not generate enough immunogenic stimulus to prevent a possible second infection.

Occupational safety and health risk assessment and management challenges in Brazil – lessons from the AquaSafe mobile software application

Introduction: AquaSafe is a mobile learning application that can be used as one of the modalities for teaching, training and risk assessment in aquaculture occupational health and safety (AOHS). The app has checklists, risk assessment tools and other relevant information on AOHS. Materials and Methods: Content information was based on global scientific literature, ILO, FAO, WHO and OHSAS 18001. An online survey is also available to identify which application tools are used and to assess the application’s effectiveness in promoting prevention of injury and illness in aquaculture workers. Results: Available for Android, its interfaces promote learning through a questionnaire;risk assessment checklists;and tools to identify the root cause of the AOHS problem. Users can find information on risks, personal protective equipment and educational videos on AOHS as well as COVID-19. Findings from the online survey revealed that most responders indicated that AquaSafe increased their knowledge of AOHS. Participants reported that risk tools, checklists and what-if are used more frequently than quizzes, videos and the “5-whys”. Conclusions: While AquaSafe is designed to support knowledge awareness, risk assessment and decision making in AOHS, it is not used widely enough. The low response rate to the survey and downloads suggest that AOHS is not a priority in low-middle income countries, such Brazil. AOHS awareness remains a challenge and requires differentiated approaches.

Unexpected Adverse Reactions Reported for COVID-19 Vaccines: A Descriptive Analysis of Spontaneous Reports Received by a Portuguese Regional Pharmacovigilance Unit: An International Journal of Medical Toxicology and Drug Experience

Background/Introduction: The approval of COVID-19 vaccines has been based on fast clinical development programs leading to limited knowledge on safety data [1]. Unexpected adverse drug reactions (ADRs), including rare ADRs or delayed ADRs from long-term exposure, may occur [2]. Moreover pre-marketing clinical trials do not have power to detect all ADRs, thereby highlighting the need to analyse post-marketing spontaneous reports (SRs). Objective/Aim: To identify unexpected ADRs associated with COVID-19 vaccines spontaneously reported to the Regional Pharmacovigilance Unit of Coimbra in Portugal (UFC). Methods: SRs of ADRs associated with COVID-19 vaccines received by UFC between 30/12/2020 and 30/04/2021 were included. ADRs were coded with MedDRA®, v.24 (System Organ Classification [SOC] and Preferred Term [PT]). ADRs were classified as "expected" or "unexpected" according to their description on the vaccines Summary of Product Characteristics (SmPC). Further, each unexpected ADR was classified as an important medical event (IME) according to the list from the European Medicines Agency (EMA). Results: A total of 771 SRs, of which 262 SRs (34%) contained a total of 420 unexpected ADRs were received. For Comirnaty®, out of 287 unexpected ADRs, 26 (9.1%) were IME. The most frequently reported IMEs were angioedema (n = 2;7.7%), bradycardia (n = 2;7.7%), death (n = 2;7.7%), deep vein thrombosis (n = 2;7.7%), ischaemic stroke (n = 2;7.7%), and seizure (n = 2;7.7%). The remaining ADRs (acute kidney injury, cardio-respiratory arrest, cerebrovascular accident, corneal opacity, haemorrhagic stroke, hypertensive crisis, laryngeal oedema, loss of consciousness, pneumonia, pulmonary oedema, sepsis, status epilepticus, tongue paralysis and upper gastrointestinal haemorrhage), had one report each (n=14;53.8%). Of the 121 unexpected ADRs reported for Vaxzevria®, 20 were IME (16.5%). The most frequently reported IMEs were ischaemic stroke (n = 5;25.0%), and conjunctival haemorrhage (n = 3;15.0%). The remaining ADRs (acute myocardial infarction, altered state of consciousness, angina pectoris, arrhythmia, death, guillain-Barre syndrome, hypothermia, mesenteric vein thrombosis, monoplegia, pericarditis, syncope and truncus coeliacus thrombosis), had one report each (n = 12;60.0%). Twelve unexpected ADRs were reported for the Moderna COVID-19 vaccine®, of which 4 IMEs (33.3%), corresponding to cerebrovascular accident (n = 1;25.0%), conjunctival haemorrhage (n = 1;25.0%), death (n = 1;25.0%) and retinal artery occlusion (n = 1;25.0%). Conclusion: A considerable proportion of SRs received by UFC contained unexpected ADRs, among which 11.9% were IMEs. These results highlight the value of post-marketing spontaneous reporting to identify unknown ADrs and to better characterize the safety profiles of newly approved COVID-19 vaccines, as well as their benefit/risk ratios.

CARACTERÍSTICAS CLÍNICAS E DESFECHOS DE PACIENTES COM DOENÇAS HEMATOLÓGICAS E DIAGNÓSTICO DE SARS-COV-2 EM HOSPITAL PÚBLICO TERCIÁRIO

Objetivos: Descrever as caracteristicas clinicas e desfechos de pacientes com doencas hematologicas e com diagnostico confirmado de SARS-CoV-2. Material e metodos: Estudo de coorte retrospectivo, realizado em hospital publico terciario de Sao Paulo-SP. Foram incluidos consecutivamente pacientes adultos com doenca hematologica cronica entre 01 de marco a 01 de agosto de 2020 que apresentaram RT-PCR para SARS-CoV-2 positivo em swab nasofaringeo. Resultados: Foram incluidos 45 pacientes, com idade media de 56,6 anos e predominio de sexo masculino (56,6%). Trinta e cinco (77,8%) apresentavam neoplasia hematologica, sendo mieloma multiplo (22,9%), linfoma nao Hodgkin (20%) e leucemia mieloide cronica (17,1%) os mais frequentes. Entre os diagnosticos nao neoplasicos, observamos maior proporcao de anemia aplasica (30%). As comorbidades associadas mais frequentes foram cardiopatia (33,3%), diabetes mellitus (26,7%), tabagismo (15,6%) e doenca renal cronica (13,3%).A maioria dos casos teve origem comunitaria (77,8%) e desconhecia contato com caso suspeito/confirmado (82,2%). Os principais sintomas relatados foram febre (66,7%), tosse (55,6%) e dispneia (48,9%). Dois pacientes eram assintomaticos no momento do diagnostico, com pesquisa realizada na triagem pre-TMO.Quarenta e dois (93,3%) pacientes necessitaram de internacao hospitalar. Entre os pacientes internados, 26 (61,9%) necessitaram de admissao em UTI, 20 (47,6%) de ventilacao mecanica (VM) e 7 (16,7%) de terapia renal substitutiva. Quatro (8,9%) pacientes permanecem internados. A taxa de letalidade geral foi 37,8% (17/45) e entre os hospitalizados foi 40,5% (17/42). A taxa de letalidade no subgrupo de pacientes com neoplasia hematologica foi 40% (14/35). Cinco pacientes apresentaram coinfeccao bacteriana confirmada no momento do diagnostico da COVID-19, com letalidade de 80%.Entre os fatores de risco para obito, Diabetes Mellitus (p = 0,014) e Doenca Renal Cronica (p = 0,024) apresentaram maior frequencia. Presenca de choque (p = 0,005), lesao renal aguda (p = 0,005) ou insuficiencia respiratoria com necessidade de VM (p=0,009) no momento do diagnostico tambem teve relacao com obito. Identificamos maior proporcao de aquisicao de COVID-19 intra-hospitalar nos pacientes que foram a obito, com diferenca estatisticamente significativa (p = 0,004). Discussao: No nosso estudo, descrevemos serie de casos de pacientes com doencas hematologicas e infeccao por SARS-CoV-2. Observamos taxa geral de letalidade de 37,8%, chegando a 40% nos pacientes com neoplasia hematologica. Esse dado se assemelha as primeiras series de casos de COVID-19 em pacientes com neoplasias hematologicas, que encontraram taxa de letalidade variando entre 32,4-61,5%. Os sintomas iniciais e comorbidades mais frequentes foram semelhantes aos ja descritos na literatura. Diabetes mellitus e DRC foram observados com maior proporcao nos pacientes que evoluiram a obito, alem de apresentacao clinica mais grave no momento do diagnostico. Aquisicao intra-hospitalar de COVID-19 tambem foi mais frequente nos casos que evoluiram a obito. Conclusao: Encontramos taxa elevada de letalidade em pacientes com doencas hematologicas. Alem dos fatores de risco ja observados, a aquisicao intra-hospitalar de COVID-19 pode estar relacionada reforcando a importancia de medidas de prevencao de transmissao nos servicos de saude.Copyright © 2020