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Case report: Chronic urticaria is defined as the presence of urticaria for a period exceeding six weeks. Infections are known as possible triggers for urticaria manifestations, and, as such, SARS-CoV- 2 infection can be recognized as causative. An 8-year- old boy, with a previous history of idiopathic chronic urticaria, came to the Emergency Department for the appearance of generalized urticaria and lips angioedema associated with vomit and shortening of breath normal vital signs by age. Thus, due to the significant reaction, intravenous corticosteroids and antihistamines were promptly administered, with a rapid improvement of symptoms. Since the systemic reaction, the tryptase dosage was performed with the identification of an elevation at the time of the arrival and a complete normalization after the twelfth hour from the beginning of the reaction. Figure 1 shows the kinetic of the tryptase over time. SARS-CoV2 swab was performed before hospitalization and a positive test was identified. To investigate the etiopathogenesis of reaction, the patient was submitted to the extensive clinical, laboratory, and instrumental investigations that revealed only a positive in vitro basophil activation test (BAT) as evidence of functional serum histamine-releasing autoantibodies that are directed against IgE or high-affinity IgE receptors. The viral infection did not need any medication, and the urticaria was resolute in a couple of days. Daily treatment with oral antihistamines was then prescribed, and no further urticarious episodes occurred. A negative SARS-CoV- 2 swab was detected within 12 days of beginning symptoms. Approximately 40% of patients with idiopathic chronic urticaria have circulating antibodies versus IgE epitopes or the IgE receptor, but as it occurs in many autoimmune conditions, the presence of autoantibodies does not necessarily result in a disease phenotype. It is demonstrated that infections can elicit an autoimmune condition, and as our report shows, SARS-CoV2 could explain the reaction observed in our patient. The autoimmune precondition could have been the primer of the systemic reaction, pre-activating the mastocyte degranulation, as the tryptase elevation demonstrated. On the other hand, the SARS-CoV2 virus reducing the ACE2 expression, due to virus endocytosis, could create an imbalance in the RAS system, increasing the bradykinin levels. Bystander activation of pre-activated mastocytes caused by an inflammatory environment could explain the systemic reaction described above.
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The COVID-19 pandemic severely hit Italy in early 2020, forcing the government to arrange a general lockdown across the country. The condition of forced quarantine, already experienced in China, has led to a worsening of symptoms in subjects already suffering from psychopathology, including Eating Disorders. To avoid this, after the closure of the Service, the Day Hospital of the Regional Center on Eating Disorders of the UO of Child Neuropsychiatry of the Azienda Policlinico S. Orsola-Malpighi of Bologna has activated an online treatment program aimed at five adolescent patients and their parents. The meetings were conducted by the Psychotherapist, the Child Neuropsychiatrist, the Dietitian and the Family Psychotherapist. During the lockdown, tests were administered to the patients, compared with test administered in the entry, to see if the symptoms related to the eating disorder and general psychopathology had changed. In addition, other tests were administered to both patients and parents with the aim of investigating the dynamics established during quarantine, which measured psychological well-being and general functioning. The observation made it possible to identify five psychological phases that the patients faced, related to eating symptoms, family dynamics and adaptation to the pandemic. The tests did not show significant changes in the psychopathology of the patients, while comparing the results of the tests also administered to the parents, an influence between mother and daughter can be seen, with often overlapping trends in relation to symptoms. The online treatment was effective and satisfactory for both patients and parents, and within the families greater moments of communication, listening and mutual involvement in the life of family members developed while maintaining personal spaces. (PsycInfo Database Record (c) 2023 APA, all rights reserved) (Italian) La pandemia COVID-19 ha gravemente colpito l'Italia nei primi mesi del 2020, costringendo il governo a predisporre un lockdown generale in tutto il paese. La condizione di quarantena forzata, gia sperimentata in Cina, ha portato un peggioramento dei sintomi in soggetti gia affetti da psicopatologia, compresi i Disturbi del Comportamento Alimentare. Per evitare questo, dopo la chiusura del Servizio, il Day Hospital del Centro Regionale sui Disturbi Alimentari dell'UO di Neuropsichiatria Infantile dell'Azienda Policlinico S. Orsola-Malpighi di Bologna ha attivato un programma di trattamento online rivolto a cinque pazienti adolescenti e ai loro genitori. Gli incontri sono stati condotti dalla Psicotera-peuta, dalla Neuropsichiatra Infantile, dalla Dietista e dalla Psicoterapeuta della famiglia. Durante il lockdown sono stati somministrati dei test alle pazienti, confrontati con quelli in entrata, per osservare se i sintomi relativi al disturbo alimentare e alla psicopatologia generale si fossero modificati. Inoltre sono stati somministrati altri test sia alle pazienti sia ai genitori con l'obiettivo di indagare le dinamiche instaurate durante la quarantena, che misuravano il benessere psicologico e il funzionamento generale. L'osservazione ha permesso di individuare cinque fasi psicologiche che hanno affrontato le pazienti, legate alla sintomatologia alimentare, alle dinamiche familiari e all'adattamento alla pandemia. I test non hanno riportato cambiamenti significativi nella psicopatologia delle pazienti, mentre confrontando i risultati dei test somministrati anche ai genitori si evince un'influenza fra madre e figlia, con andamenti spesso sovrapponibili relativamente ai quadri sintomatici. Il trattamento online e stato efficacie e soddisfacente sia per le pazienti sia per i genitori e all'interno delle famiglie si sonosviluppati maggiori momenti di comunicazione, ascolto, coinvolgimento reciproco nella vita dei familiari pur mantenendo gli spazi personali. (PsycInfo Database Record (c) 2023 APA, all rights reserved)
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Purpose: This study examines the market reaction to the World Health Organization (WHO) announcement of the novel coronavirus disease 2019 (COVID-19) as a global pandemic on the emerging equity markets and compares the reaction with developed markets. This study also compares the market reactions to the COVID-19 pandemic with the market reactions to the 2008 global financial crisis. Design/methodology/approach: Using the Morgan Stanley Capital International daily stock indices data and the Carhart and the GARCH(1,1) models for an event study, the authors examine the cumulative abnormal returns during 30 and 10 trading days and the extended 60 days before and after the WHO pandemic announcement. It also compares the market reactions during the COVID-19 pandemic with the reactions to the Lehman Brothers' bankruptcy announcement during the 2008 global financial crisis. Findings: This study finds that the COVID-19 pandemic had a significantly greater negative impact to the stock markets in emerging countries than in the developed countries. The negative impact on the emerging markets is more pronounced for firms with small market capitalizations and for growth stocks. The negative impact of the COVID-19 pandemic is stronger in the energy and financial sectors in both emerging and developed markets. The positive impact of the COVID-19 pandemic occurred in healthcare and telecommunications for the emerging markets and information technology for the developed markets. This study also finds that the equity markets in both emerging and developed countries recovered faster from the COVID-19 pandemic relative to the 2008 global financial crisis. Social implications: Investors' desire to diversify their risks across different countries and sectors in the emerging markets could bring superior returns. The diversification strategies bring critical financial supports to forestall the contagion of COVID-19, to protect lives, and to save the emerging economies, especially for those financially constrained countries that are facing twin health and economic shocks by channeling their investments to countries with weak healthcare systems. Originality/value: This study extends the literature that examines market reactions to stock market shocks by examining the market reactions to the COVID-19 outbreak on the emerging and developed equity markets across different market capitalizations, valuation and sectors. This study also finds that the markets recovered quicker from the COVID-19 pandemic announcement than during the 2008 global financial crisis. © 2021, Emerald Publishing Limited.
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"Geosafe" is a web-based service enabling insurance agencies to access a climate data-base supporting farm insurance business. Risk indexes are elaborated on the whole national territory according to the local hazard conditions and exposure. The current agrometeorological products are developed for maize, wheat, grape and olive. For each of these crops, phenological models represent the specific weather sensitivity. Meteorological informative layers are then used to define heat stresses, low temperature and drought hazards.
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Spring frost events are predicted to increase due to climate change. Yield losses caused by late radiative frosts can be highly remarkable in many fruit species, mostly stone fruits, grapes and kiwi, and active protection means are part of a general need for adaptation in orchard management. The principle of using over canopy and under canopy irrigation is based on the property of water that, when freezing, releases heat. Technical and management tools able to magnify such effect have been developed and here described for under canopy application, when the icing of water sprinkled to orchard grass allows adequate increase of the air temperature at canopy level.
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This paper investigates the changes in neighbourhood attractiveness during the Covid-19 pandemic (2020) compared to the year before in 2019 in the city of Milan. Central neighbourhoods recorded a drop in users from -63% to -47%, while the peripheral areas showed a relatively steady presence during the day. Indeed, remote working and the fear of public transport led to rethinking commuting and re-value working close to home. Semi-peripheral and peripheral neighbourhoods have gained a renewed role in attracting remote workers, and coworking spaces represent a valuable alternative for those willing to improve work-life balance through near working. Within this context, the paper aims to:(i) measure the presence of remote workers at the neighbourhood level;(ii) explore the accessibility to coworking spaces within 15 minutes of walking and cycling distance;(iii) focus on three peripheral neighbourhoods which show the lowest number of city users loss, do not host CSs, and present different levels of essential services and access to subway stations. The three cases are explored to understand whether they are considered feasible locations for hosting a neighbourhood coworking space. The change of the city users' presence in the Milan neighbourhoods in 2019-2020 is analysed using << TIM Big Data - Data Visual Insight >>, which includes the presence and mobility of the TIM mobile network's users.
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Introduction: Recently mRNA-based COVID-19 vaccines have been approved also for use in pediatric population. Vaccines safety require particular attention in this population. Analysis of pharmacovigilance database allows to extrapolate important information to identify possible safety signals. Objective(s): Our pharmacovigilance study aims to describe and evaluate the onset of adverse events following immunization (AEFIs) with COVID-19 mRNA vaccines in the pediatric population. Method(s): We retrieved all pediatric Individual Case Safety Reports (ICSRs) collected in the European pharmacovigilance database, Eudravigilance from the 01/01/2021 to 4/03/2022 related to Spikevax and Comirnaty. We carried out a disproportionality analysis (Reporting Odds Ratio-95% CI) to compare the reporting probability of some AEFIs of interest (seizure, pericarditis, myocarditis, multisystem inflammatory syndrome (MIS), menstrual disorders, failure and anaphylactic shock) between Comirnaty and Spikevax. Result(s): We retrieved in Eudravigilance 25.019 ICSR related to Comirnaty describing a total of 75.040 AEFIs and 1.862 ICSRs referred to Spikevax reporting overall 5.361 AEFIs occurred in pediatric population. Majority of ICSRs reported well-known general disorders (headache, pyrexia, fatigue and nausea) for both mRNA vaccines. ICSRs were more frequently referred the adolescent patients (Comirnaty, 86.2%;Spikevax, 86.4%). We found a slight prevalence of female gender for both mRNA vaccine (Spikevax, 52.6 %;Comirnaty 53.9%). Reproductive system disorders were more frequently referred to females. In particular, these events included menstrual disorders (N = 609, Comirnaty;N = 23, Spikevax), amenorrhoea (N = 408, Comirnaty;N = 16, Spikevax) or intermenstrual bleeding (N = 169, Comirnaty;N = 10, Spikevax), polymenorrhoea (N = 172, Comirnaty;N = 10, Spikevax). Few cases described reproductive system disorders in males, mainly related to Comirnaty. These AEFIs included testicular pain (N = 14, Comirnaty;N = 1, Spikevax), erectile dysfunction (N = 5, Comirnaty), testicular torsion (N = 4, Comirnaty) or swelling (N = 4, Comirnaty), scrotal pain (N = 3, Comirnaty) or oedema (N = 1, Comirnaty). Outcome of AEFIs was unknown in 14.8% and 21.1% cases for Spikevax and Comirnaty, respectively. AEFIs had a favorable outcome in more than 50% of cases for both mRNA vaccines, including a complete resolution (30%) or an ongoing resolution (20%). From disproportionality analysis emerged a statistically significant ROR for menstrual disorders (ROR 1.72, 95% CI 1.43-2.10;p<0.05), failure (ROR 8.11, 95% CI 5.05-13.97;p<0.05) and seizure (ROR 1.54, 95% CI 1.03-2.41;p = 0.037) when compared Comirnaty versus Spikevax. Conclusion(s): Majority of pediatric AEFIs are mild and with a positive outcome, supporting the role of ongoing COVID-19 vaccination campaign in this population as a critical public health tool for disease prevention and control of pandemic. Further investigations are needed in this population.
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Introduction: Rare or serious Adverse Events (AEs) in the reproductive sphere have been reported following the administration of the COVID-19 vaccine, especially mRNA vaccines. Although several fertility Societies have announced that COVID-19 mRNA vaccines are unlikely to affect fertility, pregnancy, or breastfeeding, there is no denying that the current evidence is very limited [1]. Objective(s): Aim of this study was a post-marketing assessment of the safety profile of COVID-19 vaccines, through the analysis of the Individual Case Safety Reports (ICSRs) collected in EudraVigilance in 2021 year, by focusing on reproductive disorders. Method(s): We analyzed all ICSRs that contained at least one COVID- 19 vaccine as suspected and at least one AE belonging to the Standardized MedDRA Query (SMQ) level 1 ''Fertility disorders'' or ''Pregnancy and neonatal conditions''. We performed a descriptive analysis and all AEs have been coded as Preferred Term (PT) according to MedDRA. Finally, we used the Reporting Odds Ratio (ROR) with a 95% of Confidence Interval (95% CI) to investigate disproportional reporting of AEs belonging to the SMQs of interest among the vaccines included in the analysis. Result(s): During the study period, 27,089 ICSR were collected and the total number of AEs was found to be 31,337;of these, 62.8% were referred to Comirnaty-, 20.8% to Spikevax-, 12.7% to Vaxzevria-, and 3.7% to Janssen-. For each of the four COVID-19 vaccines, 96.4% were related to female patients, aged between 18-64 years (88.1%), 71.5% were not serious, 46.0% were not resolved yet and 82.3% were reported by non-healthcare professionals. Regardless of the type of vaccine, the most reported PTs were amenorrhea, irregular menstruation, and delayed menstruation. The ROR showed that the probability to report an AE belonging to the SMQ ''Fertility disorders'' is greater for Comirnaty (ROR: 4.20, 95% CI 4.08-4.32) while no statistically significant difference was observed to the SMQ ''Pregnancy and neonatal conditions''. Conclusion(s): In this study, no potential signs of reproductive system safety were found regarding fertility, pregnancy or breastfeeding. Most of the reported events were related to changes in the menstrual cycle, although these disorders are temporary and normally common in the female population. At the time, the EMA's PRAC concluded that the evidence did not support a causal link between these vaccines and menstrual disorders, however, it decided to further studies collecting data from real life contexts are strongly needed to assess their safety profile in relation to reproductive function.
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Introduction: Recently, capillary leak syndrome (CLS) emerged as new suspected adverse event after immunization (AEFI) associated to COVID-19 vaccination. This condition is rare, but serious and potentially fatal [1]. Objective(s): Our pharmacovigilance study aims to evaluate the onset of CLS as AEFI with COVID-19 mRNA vaccines (Spikevax and Comirnaty) compared to viral vector vaccines (Janssen and Vaxzevria). Method(s): We carried out descriptive and disproportionality analyses of all Individual Case Safety Reports (ICSRs) reporting a vaccine COVID-19 as suspected drug and the CLS as AEFI, which were collected in the pharmacovigilance database EudraVigilance from January 1st, 2021, to January 14th, 2022. For the disproportionality analysis we applied the Reporting Odds Ratio (ROR) 95% CI. Result(s): During study period, CLS was described as AEFI in 84 out of 1,357,962 ICRs reporting a vaccine COVID-19 as suspected drug and collected in the EV database. Overall, the ICSR reported by CLS were mainly related to the viral vector COVID-19, Vaxzevria-, (N = 36) and Janssen-, (N = 9), while the ICSR reported to vaccines COVID-19 mRNA were 39 (Comirnaty-, N = 33;Spikevax-, N = 6). Majority of ICSRs were reported by healthcare professionals (N = 60;71.4%). The nonhealthcare professional represented the primary source in the 41.7% of Vaxzevria related ICSRs. Majority of the patients were adult (N = 49;58.3%). The female gender accounted in more than 65% of ICSRs referred both to mRNA and viral vector vaccines. The CLS outcome was more frequently favorable in mRNA ICSRs (N = 13;33,3%). On the other hand, among the ICSRs reporting CLS with unfavorable outcome (N = 25;29.8%) we found 9 ICSRs describing fatal CLS (Comirnaty N = 1;Vaxzevria N = 4;Janssen N = 4). From disproportionality analysis emerged a lower CLS reporting probability after COVID-19 vaccination with mRNA vaccines compared to viral vector-based ones. Conclusion(s): According to our results, few ICSRs describing CLS have been collected in EV in front of billion administered doses. This could underline the rarity of this AEFI or the limit of underreporting of spontaneous reporting and therefore also our study. Since the significant clinical relevance of CLS, this AEFI requires a careful monitoring. Healthcare professionals as well as patients should be aware of the signs and symptoms of CLS. Patients with a history of CLS require particular attention because of a possible risk of flare-up of disease. Since a precise mechanism is still not identified, further studies are necessary to confirm the causal relationship between CLS and COVID-19 vaccination.
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Introduction: As part of post-authorization safety surveillance, the European Medicines Agency (EMA) has identified a potential safety concern for Guillain-Barre syndrome (GBS) following COronaVIrusDisease 2019 (COVID-19) vaccines [1,2]. Objective(s): To assess reports of GBS reported in the Vaccine Adverse Event Reporting System (VAERS) following COVID-19 vaccination and to evaluate if a COVID-19 vaccine has a lower/higher probability of reporting Individual Case Safety Reports (ICSRs) with GBS in a direct comparison with all other COVID-19 vaccines. Method(s): After selecting all ICRSs of GBS following vaccination reported in VAERS from 1 January 2021 to 31 December 2021, we assessed them through the case definition and classification of the Brighton Collaboration (BC). We performed a descriptive analysis. Finally, we used the Reporting Odds Ratio with a 95% of Confidence Interval to investigate disproportional reporting of GBS among the vaccines included in the analysis. Result(s): 774 ICSRs of GBS have been reported in VAERS, and 279 of them met the BC Case Definition: 30 (10.7%) have been evaluated as Definitive, 56 (20.0%) as Probable, and 193 (69.3%) as Possible. COVID-19 Vaccine Pfizer-BioNTech was the most commonly vaccine reported (N = 118;42.3%) followed by COVID-19 Vaccine Moderna (N = 82;29.4%) and COVID-19 Vaccine Janssen (N = 79;28.3%). GBS was more commonly reported for male subjects (N = 143;51.3%) aged between 12 and 20 years (N = 59;21.1%). GBS mainly occurred between the 1st and 12th day following the first dose administration of mRNA vaccines and between the 4th and the 15th day following COVID-19 Vaccine Janssen. COVID-19 Vaccine Janssen was significantly associated with increased risks for Guillan- Barre syndrome (ROR 3.47, CI 95% = 2.58-4.65) compared to COVID-19 Vaccine Pfizer-BioNTech and COVID-19 Vaccine Moderna. Conclusion(s): GBS is an adverse event of special interest for all COVID-19 vaccines requiring specific safety monitoring. GBS is very rare, and the benefit-risk balance of the vaccine remains unchanged.
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Introduction: Recently mRNA-based COVID-19 vaccines have been approved also for use in pediatric population. Vaccines safety require particular attention in this population. Analysis of pharmacovigilance database allows to extrapolate important information to identify possible safety signals. Objective: Our pharmacovigilance study aims to describe and evaluate the onset of adverse events following immunization (AEFIs) with COVID-19 mRNA vaccines in the pediatric population. Methods: We retrieved all pediatric Individual Case Safety Reports (ICSRs) collected in the European pharmacovigilance database, Eudravigilance from the 01/01/2021 to 4/03/2022 related to Spikevax and Comirnaty. We carried out a disproportionality analysis (Reporting Odds Ratio-95% CI) to compare the reporting probability of some AEFIs of interest (seizure, pericarditis, myocarditis, multisystem inflammatory syndrome (MIS), menstrual disorders, failure and anaphylactic shock) between Comirnaty and Spikevax. Results: We retrieved in Eudravigilance 25.019 ICSR related to Comirnaty describing a total of 75.040 AEFIs and 1.862 ICSRs referred to Spikevax reporting overall 5.361 AEFIs occurred in pediatric population. Majority of ICSRs reported well-known general disorders (headache, pyrexia, fatigue and nausea) for both mRNA vaccines. ICSRs were more frequently referred the adolescent patients (Comirnaty, 86.2%;Spikevax, 86.4%). We found a slight prevalence of female gender for both mRNA vaccine (Spikevax, 52.6 %;Comirnaty 53.9%). Reproductive system disorders were more frequently referred to females. In particular, these events included menstrual disorders (N = 609, Comirnaty;N = 23, Spikevax), amenorrhoea (N = 408, Comirnaty;N = 16, Spikevax) or intermenstrual bleeding (N = 169, Comirnaty;N = 10, Spikevax), polymenorrhoea (N = 172, Comirnaty;N = 10, Spikevax). Few cases described reproductive system disorders in males, mainly related to Comirnaty. These AEFIs included testicular pain (N = 14, Comirnaty;N = 1, Spikevax), erectile dysfunction (N = 5, Comirnaty), testicular torsion (N = 4, Comirnaty) or swelling (N = 4, Comirnaty), scrotal pain (N = 3, Comirnaty) or oedema (N = 1, Comirnaty). Outcome of AEFIs was unknown in 14.8% and 21.1% cases for Spikevax and Comirnaty, respectively. AEFIs had a favorable outcome in more than 50% of cases for both mRNA vaccines, including a complete resolution (30%) or an ongoing resolution (20%). From disproportionality analysis emerged a statistically significant ROR for menstrual disorders (ROR 1.72, 95% CI 1.43-2.10;p < 0.05), failure (ROR 8.11, 95% CI 5.05-13.97;p < 0.05) and seizure (ROR 1.54, 95% CI 1.03-2.41;p = 0.037) when compared Comirnaty versus Spikevax. Conclusion: Majority of pediatric AEFIs are mild and with a positive outcome, supporting the role of ongoing COVID-19 vaccination campaign in this population as a critical public health tool for disease prevention and control of pandemic. Further investigations are needed in this population.
ABSTRACT
Introduction: Rare or serious Adverse Events (AEs) in the reproductive sphere have been reported following the administration of the COVID-19 vaccine, especially mRNA vaccines. Although several fertility Societies have announced that COVID-19 mRNA vaccines are unlikely to affect fertility, pregnancy, or breastfeeding, there is no denying that the current evidence is very limited [1]. Objective: Aim of this study was a post-marketing assessment of the safety profile of COVID-19 vaccines, through the analysis of the Individual Case Safety Reports (ICSRs) collected in EudraVigilance in 2021 year, by focusing on reproductive disorders. Methods: We analyzed all ICSRs that contained at least one COVID-19 vaccine as suspected and at least one AE belonging to the Standardized MedDRA Query (SMQ) level 1 "Fertility disorders" or "Pregnancy and neonatal conditions". We performed a descriptive analysis and all AEs have been coded as Preferred Term (PT) according to MedDRA. Finally, we used the Reporting Odds Ratio (ROR) with a 95% of Confidence Interval (95% CI) to investigate disproportional reporting of AEs belonging to the SMQs of interest among the vaccines included in the analysis. Results: During the study period, 27,089 ICSR were collected and the total number of AEs was found to be 31,337;of these, 62.8% were referred to Comirnaty®, 20.8% to Spikevax®, 12.7% to Vaxzevria®, and 3.7% to Janssen®. For each of the four COVID-19 vaccines, 96.4% were related to female patients, aged between 18-64 years (88.1%), 71.5% were not serious, 46.0% were not resolved yet and 82.3% were reported by non-healthcare professionals. Regardless of the type of vaccine, the most reported PTs were amenorrhea, irregular menstruation, and delayed menstruation. The ROR showed that the probability to report an AE belonging to the SMQ "Fertility disorders" is greater for Comirnaty® (ROR: 4.20, 95% CI 4.08-4.32) while no statistically significant difference was observed to the SMQ "Pregnancy and neonatal conditions". Conclusion: In this study, no potential signs of reproductive system safety were found regarding fertility, pregnancy or breastfeeding. Most of the reported events were related to changes in the menstrual cycle, although these disorders are temporary and normally common in the female population. At the time, the EMA's PRAC concluded that the evidence did not support a causal link between these vaccines and menstrual disorders, however, it decided to further studies collecting data from real life contexts are strongly needed to assess their safety profile in relation to reproductive function.
ABSTRACT
Introduction: Recently, capillary leak syndrome (CLS) emerged as new suspected adverse event after immunization (AEFI) associated to COVID-19 vaccination. This condition is rare, but serious and potentially fatal [1]. Objective: Our pharmacovigilance study aims to evaluate the onset of CLS as AEFI with COVID-19 mRNA vaccines (Spikevax and Comirnaty) compared to viral vector vaccines (Janssen and Vaxzevria). Methods: We carried out descriptive and disproportionality analyses of all Individual Case Safety Reports (ICSRs) reporting a vaccine COVID-19 as suspected drug and the CLS as AEFI, which were collected in the pharmacovigilance database EudraVigilance from January 1st, 2021, to January 14th, 2022. For the disproportionality analysis we applied the Reporting Odds Ratio (ROR) 95% CI. Results: During study period, CLS was described as AEFI in 84 out of 1,357,962 ICRs reporting a vaccine COVID-19 as suspected drug and collected in the EV database. Overall, the ICSR reported by CLS were mainly related to the viral vector COVID-19, Vaxzevria®, (N = 36) and Janssen®, (N = 9), while the ICSR reported to vaccines COVID-19 mRNA were 39 (Comirnaty®, N = 33;Spikevax®, N = 6). Majority of ICSRs were reported by healthcare professionals (N = 60;71.4%). The non-healthcare professional represented the primary source in the 41.7% of Vaxzevria® related ICSRs. Majority of the patients were adult (N = 49;58.3%). The female gender accounted in more than 65% of ICSRs referred both to mRNA and viral vector vaccines. The CLS outcome was more frequently favorable in mRNA ICSRs (N = 13;33,3%). On the other hand, among the ICSRs reporting CLS with unfavorable outcome (N = 25;29.8%) we found 9 ICSRs describing fatal CLS (Comirnaty® N = 1;Vaxzevria® N = 4;Janssen® N = 4). From disproportionality analysis emerged a lower CLS reporting probability after COVID-19 vaccination with mRNA vaccines compared to viral vector-based ones. Conclusion: According to our results, few ICSRs describing CLS have been collected in EV in front of billion administered doses. This could underline the rarity of this AEFI or the limit of underreporting of spontaneous reporting and therefore also our study. Since the significant clinical relevance of CLS, this AEFI requires a careful monitoring. Healthcare professionals as well as patients should be aware of the signs and symptoms of CLS. Patients with a history of CLS require particular attention because of a possible risk of flare-up of disease. Since a precise mechanism is still not identified, further studies are necessary to confirm the causal relationship between CLS and COVID-19 vaccination.
ABSTRACT
Introduction: As part of post-authorization safety surveillance, the European Medicines Agency (EMA) has identified a potential safety concern for Guillain-Barre syndrome (GBS) following COronaVIrusDisease 2019 (COVID-19) vaccines [1,2]. Objective: To assess reports of GBS reported in the Vaccine Adverse Event Reporting System (VAERS) following COVID-19 vaccination and to evaluate if a COVID-19 vaccine has a lower/higher probability of reporting Individual Case Safety Reports (ICSRs) with GBS in a direct comparison with all other COVID-19 vaccines. Methods: After selecting all ICRSs of GBS following vaccination reported in VAERS from 1 January 2021 to 31 December 2021, we assessed them through the case definition and classification of the Brighton Collaboration (BC). We performed a descriptive analysis. Finally, we used the Reporting Odds Ratio with a 95% of Confidence Interval to investigate disproportional reporting of GBS among the vaccines included in the analysis. Results: 774 ICSRs of GBS have been reported in VAERS, and 279 of them met the BC Case Definition: 30 (10.7%) have been evaluated as Definitive, 56 (20.0%) as Probable, and 193 (69.3%) as Possible. COVID-19 Vaccine Pfizer-BioNTech was the most commonly vaccine reported (N = 118;42.3%) followed by COVID-19 Vaccine Moderna (N = 82;29.4%) and COVID-19 Vaccine Janssen (N = 79;28.3%). GBS was more commonly reported for male subjects (N = 143;51.3%) aged between 12 and 20 years (N = 59;21.1%). GBS mainly occurred between the 1st and 12th day following the first dose administration of mRNA vaccines and between the 4th and the 15th day following COVID-19 Vaccine Janssen. COVID-19 Vaccine Janssen was significantly associated with increased risks for GuillanBarre syndrome (ROR 3.47, CI 95% = 2.58-4.65) compared to COVID-19 Vaccine Pfizer-BioNTech and COVID-19 Vaccine Moderna. Conclusion: GBS is an adverse event of special interest for all COVID-19 vaccines requiring specific safety monitoring. GBS is very rare, and the benefit-risk balance of the vaccine remains unchanged.
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Traditional paper-based children's spelling assessments were hampered due to Covid-19 because existing technologies did not provide strategic signals to teachers, such as the child's handwriting direction and how they read what they write. Our project emerged as a novel method to assess children's spelling by touchscreens in this context. Hence, this paper aims to extend community knowledge concerning children's experience and perception of handwriting spelling on tablet devices. The experiment consisted in presenting three handwriting methods (paper and pencil, finger and pen writing) and was conducted with eight Brazilian children between 4.5 and 7 years old. In addition to observation, in our experimental protocol we adopted the Fun Sorter, Again-Again Table, and the Smileyometer as evaluation tools. Our results show children were excited about handwriting using a touch pen on the tablet. Most of them even revealed they prefer the pen tablet mode to the traditional paper and pencil mode. However, the majority of children did not feel comfortable writing by finger, and it required more time than other methods. Furthermore, we observed child's handwriting using finger looks different when compared to paper and pencil, while the tracing using a touch pen is similar to the registration produced on paper. © 2022 Owner/Author.
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Coworking space is predominantly an urban phenomenon. Nevertheless, in the last few years, peripheral and rural areas are becoming attractive for this typology of new working spaces, but the literature on this topic is scant. The current paper aims to fill this gap by reviewing the studies on this issue and discussing the renewed role of coworking spaces in peripheral and rural areas during the Covid-19 pandemic, focusing on Italy. Moreover, a detailed and updated picture of the increasing number of coworking spaces in 2018-2020 in the Italian Inner Areas and rural areas is provided. Finally, some case studies of peripheral and rural coworking spaces are presented, followed by conclusions and further research. © 2021 FrancoAngeli. All rights reserved.
ABSTRACT
The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is responsible for the COVID-19 pandemic.According to the CDC, RT-PCR in respiratory samples is the gold standard for confirming the disease, although it has practical limitations as time-consuming procedures and a high rate of false-negative results. Based on data collected at Careggi Hospital from April 7th-30th 2020,we aim to assess the accuracy of a COVID-19 diagnosis through classification methods based on blood tests and information collected at the ED. 971 pts with pre-specified features of suspected COVID-19 were enrolled;physicians prospectively dichotomized patients in COVID-19 likely/unlikely based on clinical features plus results of bedside imaging.Considering the limits of each method to classify a case COVID-19 positive, further evaluation was performed to form the COVID-19 final diagnosis, established after independent clinical review of 30-day follow-up data. Several classifiers were implemented, both parametric (Logistic Regression, LR;Quadratic Discriminant Analysis, QDA) and non-parametric (Random Forest, RF;Support Vector Machine;Neural Networks;K-nearest neighbour;Naive Bayes). Log transform was applied to some of the covariates and results compared with non transformed data.The dataset was divided in training and validation sets.Results based on validation sample show an AUC>0.8 for all classifiers. Best results are obtained applying RF, LR and QDA to a rebalanced sample using the SMOTE techniques on the log transformed data, showing an AUC of 0.890 (LR),0.896 (QDA) and 0.864 (RF). In parallel, best Sens and Spec are obtained via the above methods, the highest chieved by the LR (Sens 0.696;Spec 0.877). The rather high rate of false negative seems to be a feature inherently characterizing this classification problem.Good discriminatory power was shown for: WBC, Neut, AST, LDH, PCR, Na, IL-6 plus symptoms' information. Parametric models have the additional advantage of allowing a scientific interpretation.The performance of the classifiers with respect to the physician's gestalt and data validation are ongoing. The proposed classifiers show a good level of Sens.To improve Spec, a 3-level classification can be implemented;this tool can help in taking decisions when time and resources are scarce.