Virtual learning before and during the COVID-19 pandemic: A mixed methods study of Pharmacy students

Background It is a challenge for pharmacy courses worldwide to combine theoretical knowledge with practical skills to equip students for their future practice. Computer-based simulation offers a way of building a bridge between theory and practice. In recent years, digital simulation has expanded rapidly as a new technique of virtual learning. The digital platform ''Pharmacy Simulator'' proposes computer-based encounters with virtual patients to train clinical and communication skills in a community pharmacy setting. However, during the COVID-19 pandemic, while students were digitally resilient and endured the endless challenges of online lectures, many were dealing with Zoom and screen fatigue. Purpose To investigate pharmacy students' acceptance of Pharmacy Simulator before and during a pandemic situation. This focuses on students' self-assessment and confidence in counselling after playing the scenarios on Pharmacy Simulator. Method Two cohorts of Master of Pharmacy students at The University of Western Australia played two scenarios on Pharmacy Simulator in 2019 (anaphylaxis and salbutamol) and 2021 (anaphylaxis and vaccination). A mixed-method analysis was performed with data from (i) qualitative semi-structured interviews carried out in 2019 pertaining to participants' acceptance of Pharmacy Simulator and in 2021 (ii) a questionnaire with 25 items derived from the interviews. The interviews were transcribed verbatim into electronic format with the data management assistance MAXQDA and analyzed inductively using the Framework Method. Questionnaire responses were analyzed in Microsoft Excel using descriptive statistics. Openended questions were evaluated inductively. Findings Data were collected from 20 interviews and 31 answered questionnaires. In 2019, participants reported that Pharmacy Simulator was a fun, engaging, and straightforward learning tool and, therefore, user-friendly. They reported the feedback at the end of the session to be most valuable. The platform was perceived to fill the gap between the theory from lectures and community pharmacy practice. In 2021, participants ''agreed'' (median: 4, on a 5-point Likert scale) with seven statements about Pharmacy Simulator's usability, such as it being a helpful tool for acquiring new knowledge. Participants' confidence in counselling regarding the scenario topics improved. One participant stated, ''It taught me more through trial and error''. Conclusion Pharmacy students reported similar acceptance levels of Pharmacy Simulator before and during the COVID-19 pandemic. The use of simulation during virtual patient encounters seems to facilitate the transfer from theory to practice, independently of learning conditions that were predominantly screen-based.

Mastocytosis and COVID19 infection and vaccination: A pediatric series

Introduction: Mastocytosis encompasses a heterogeneous group of diseases characterized by an accumulation of clonal mast cells (MC) in the skin and/or internal organs, and symptoms of MC activation. This MC activation can be elucidated by several factors, including infections or vaccination. Objective(s): We present our experience with COVID infection and vaccination in a series of 133 patients with pediatric mastocytosis. Method(s): Between January 1998 and December 2022, 133 pediatric patients have been referred to our hospital owing to clinically suspected MC disorder, mainly with mastocytosis in the skin. The final diagnoses of mastocytosis were established by the presence of typical skin lesions together with an increase of MC numbers in a biopsy from lesional skin or activating KIT mutations in lesional skin tissue. Serum baseline tryptase and total immunoglobulin E levels were measured, and patients underwent a comprehensive allergy workup to confirm atopic status and history of anaphylaxis. Regarding vaccination, REMA's (Spanish Network on Mastocytosis) protocol was followed. Result(s): 13 patients with COVID infection were identified, of which 25 (56,8%) were female and 0% had symptoms of MC activation. All of them had an asymptomatic or mild course of COVID infection. None of the patients experimented MC activation symptoms during viral illness. Regarding COVID vaccination, all patients received premedication with antihistamine 60 minutes prior vaccination. No one experimented immediate reactions and only one patient (0,75%) referred worsening of MC activation symptoms (baseline pruritus, urtication and brain fog) only after the first doses, recovering without changes in his treatment (oral cromoglycate and antihistamine) in two months. Discussion(s): Although MC have been implicated in the pathogenesis of cytokine storm in COVID19, there is no clinical evidence of SARSCoV- 2-induced MC activation, perhaps related to the fact that bone marrow MC lack angiotensin-converting enzyme 2 receptors.

Erratum: Intradermal testing with COVID-19 mRNA vaccines predicts tolerance.

[This corrects the article DOI: 10.3389/falgy.2022.818049.].

Updated Guidance Regarding The Risk ofAllergic Reactions to COVID-19 Vaccines and Recommended Evaluation and Management: A GRADE Assessment, and International Consensus Approach.

This guidance updates 2021 GRADE recomendations regarding immediate allergic reactions following COVID-19 vaccines and addresses re-vaccinating individuals with 1st dose allergic reactions and allergy testing to determine re-vaccination outcomes. Recent meta-analyses assessed the incidence of severe allergic reactions to initial COVID-19 vaccination, risk of mRNA-COVID-19 re-vaccination after an initial reaction, and diagnostic accuracy of COVID-19 vaccine and vaccine excipient testing in predicting reactions. GRADE methods informed rating the certainty of evidence and strength of recommenations. A modified Delphi panel consisting of experts in allergy, anaphylaxis, vaccinology, infectious diseases, emergency medicine, and primary care from Australia, Canada, Europe, Japan, South Africa, the UK, and the US formed the recommendations. We recommend vaccination for persons without COVID-19 vaccine excipient allergy, and re-vaccination after a prior immediate allergic reaction. We suggest against >15-minute post-vaccination observation. We recommend against mRNA vaccine or excipient skin testing to predict outcomes. We suggest re-vaccination of persons with an immediate allergic reaction to the mRNA vaccine or excipients be performed by a person with vaccine allergy expertise, in a properly equipped setting. We suggest against pre-medication, split-dosing, or special precautions because of a comorbid allergic history.

Role of anti-polyethylene glycol (PEG) antibodies in the allergic reactions to PEG-containing Covid-19 vaccines: Evidence for immunogenicity of PEG.

A small fraction of recipients who receive polyethylene-glycol (PEG)-containing COVID-19 mRNA-LNP vaccines (Comirnaty and Spikevax) develop hypersensitivity reactions (HSRs) or anaphylaxis. A causal role of anti-PEG antibodies (Abs) has been proposed, but not yet been proven in humans.We used ELISA for serial measurements of SARS-CoV-2 neutralizing Ab (anti-S) and anti-PEG IgG/IgM Ab levels before and after the first and subsequent booster vaccinations with mRNA-LNP vaccines in a total of 291 blood donors. The HSRs in 15 subjects were graded and correlated with anti-PEG IgG/IgM, just as the anti-S and anti-PEG Ab levels with each other. The impacts of gender, allergy, mastocytosis and use of cosmetics were also analyzed. Serial testing of two or more plasma samples showed substantial individual variation of anti-S Ab levels after repeated vaccinations, just as the levels of anti-PEG IgG and IgM, which were over baseline in 98-99 % of unvaccinated individuals. About 3-4 % of subjects in the strongly left-skewed distribution had 15-45-fold higher values than the median, referred to as anti-PEG Ab supercarriers. Both vaccines caused significant rises of anti-PEG IgG/IgM with >10-fold rises in about âˆ¼10 % of Comirnaty, and all Spikevax recipients. The anti-PEG IgG and/or IgM levels in the 15 vaccine reactors (3 anaphylaxis) were significantly higher compared to nonreactors. Serial testing of plasma showed significant correlation between the booster injection-induced rises of anti-S and anti-PEG IgGs, suggesting coupled anti-S and anti-PEG immunogenicity.Conclusions: The small percentage of people who have extremelevels of anti-PEG Ab in their blood may be at increased risk for HSRs/anaphylaxis to PEGylated vaccines and other PEGylated injectables. This risk might be further increased by the anti-PEG immunogenicity of these vaccines. Screening for anti-PEG Ab "supercarriers" may help predicting reactors and thus preventing these adverse phenomena.

Allergic reactions of COVID-19 vaccine based on mRNA-LNP and its pharmacokinetics in vivo

Vaccination has been proved to be the most effective strategy to prevent the Corona Virus Disease 2019 (COVID-19). The mRNA vaccine based on nano drug delivery system (NDDS) - lipid nanoparticles (LNP) has been widely used because of its high effectiveness and safety. Although there have been reports of severe allergic reactions caused by mRNA-LNP vaccines, the mechanism and components of anaphylaxis have not been completely clarified yet. This review focuses on two mRNA-LNP vaccines, BNT162b2 and mRNA-1273. After summarizing the structural characteristics, potential allergens, possible allergic reaction mechanism, and pharmacokinetics of mRNA and LNP in vivo, this article then reviews the evaluation methods for patients with allergic history, as well as the regulations of different countries and regions on people who should not be vaccinated, in order to promote more safe injection of vaccines. LNP has become a recognized highly customizable nucleic acid delivery vector, which not only shows its value in mRNA vaccines, but also has great potential in treating rare diseases, cancers and other broad fields in the future. At the moment when mRNA-LNP vaccines open a new era of nano medicine, it is expected to provide some inspiration for safety research in the process of research, development and evaluation of more nano delivery drugs, and promote more nano drugs successfully to market.Copyright © 2023, Chinese Pharmaceutical Association. All rights reserved.

Vaccination

The importance of global vaccines for various infectious agents has been emphasized through our experience with the current COVID-19 vaccine. Physicians trained in allergy and immunology are considered experts in vaccines and adverse reactions from vaccines. This chapter will emphasize how to approach vaccines for various populations, including immunodeficient patients, how to determine best paths for patients who miss vaccine doses, and how to address adverse reactions to vaccines, as noted in Case 2, where the patient experienced an anaphylactic reaction to the measles, mumps, and rubella (MMR) vaccine. In addition, mechanisms behind adverse vaccine reactions are discussed. © The Editor(s) (if applicable) and The Author(s), under exclusive license to Springer Nature Switzerland AG 2022.

Safety and effectiveness of SARS-CoV-2 vaccination in patients with autoimmune liver diseases-a multi-center, questionnairesbased study

Purpose: The efficacy and safety of SARS-CoV-2 vaccination have been confirmed in several clinical trials. However, patients with autoimmune liver disease were not subject to clinical trials, and data on the efficacy and safety of vaccines have been not available in these population. Therefore, we retrospectively investigated the safety and effectiveness of SARS-CoV-2 vaccination by questionnaire survey targeting Japanese patients with autoimmune hepatitis (AIH) and primary biliary cholangitis (PBC). Method(s): This is a multi-center, retrospective, cross-sectional, questionnaires-based study. Patients with AIH and PBC who are outpatients at participating facilities, 18 years of age or older, and have given consent to participate in this study are included. We distributed questionnaires asking about sex, date of birth, number and type of vaccinations, the presence and degree of adverse effects (AEs), and the presence or absence of SARS-CoV-2 infection before and after vaccination, and asked them to fill in the questionnaire. In addition, we collected the result of liver tests before and after vaccinations of participating patients from each facility. Result(s): The survey was conducted from September 2021 to May 2022. A total of 471 questionnaires were collected from 220 AIH patients (male/female = 33/187, average age 63.5 +/- 13.1 years old) and 251 PBC patients (38/213, 65.8 +/- 10.1). The number of vaccinations was 0/1/2/unknown = 4/0/210/6 for AIH and 4/2/244/1 for PBC. The median time from the second dose to the completion of the questionnaire was 156 days for AIH and 148 days for PBC. By vaccine type, 193 Pfizer, 11 Moderna, and 16 unknown in AIH, and 223/12/16 in PBC. As for AEs, pain and swelling at the injection site were the most common in both AIH and PBC (75% in the first and 64% in the second in AIH, 64%/61% in PBC), followed by general malaise (19%/21% in AIH, 19%/31% in PBC), and myalgia (16%/ 19% in AIH, 19%/14% in PBC). Fever above 38.5 degreeC was observed in 11%/11% of AIH and 11%/24% of PBC, indicating that more patients with PBC experiencing fever that AIH. Only 1 case of PBC had an anaphylactic reaction. By comparing liver tests before and after vaccinations, 4 (1.8%) and 16 (6.4%) patients with AIH and PBC, respectively, demonstrated elevation to 1.5 times the pre-vaccination value and exceeding the upper normal limit. No patients experienced severe deterioration of liver function. SARS-CoV-2 infection was reported in 4 cases (1.8%) in AIH and 3 cases (1.3%) in PBC. Conclusion(s): The safety and effectiveness of SARS-CoV-2 vaccination is comparable to those in the general population.

Oral side effects of COVID-19 vaccines in 32 European countries: Analysis of EudraVigilance reports.

The recent reports of oral side effects (SEs) following COVID-19 vaccination warrant further investigation into their prevalence, severity, and aetiology. This study was conducted to synthesize the first-ever population-level evidence about oral SEs of COVID-19 vaccines in Europe. The European Union Drug Regulating Authorities Pharmacovigilance (EudraVigilance) database was accessed in August 2022 to extract summary data of all potential oral SEs reported after COVID-19 vaccination. The data were reported descriptively and cross-tabulated to facilitate sub-group analysis per vaccine type, sex, and age group. Dysgeusia was the most commonly reported oral SE (0.381 case per each 100 received reports), followed by oral paraesthesia (0.315%), ageusia (0.296%), lip swelling (0.243%), dry mouth (0.215%), oral hypoaesthesia (0.210%), swollen tongue (0.207%), and taste disorder (0.173%). Females had significantly (Sig. < 0.001) a higher prevalence of all most common (top 20) oral SEs, except for salivary hypersecretion, which was equally prevalent among females and males. The present study revealed a low prevalence of oral SEs, with taste-related, other sensory and anaphylactic SEs being the most common SEs in Europe, similar to what was found earlier among the US population. Future studies should explore the potential risk factors of oral sensory and anaphylactic SEs to verify whether they are causally linked to COVID-19 vaccines.

Imprecision in adverse event reports following immunization against HPV in Japan and COVID-19 in the USA, UK, and Japan-and the effects of vaccine hesitancy and government policy.

INTRODUCTION: Erroneous reports of adverse events following immunization (AEFIs) likely exacerbated the 2013 collapse of Japan's HPV immunization program. A similar phenomenon characterized the first months of COVID-19 immunization programs in the USA, UK, and Japan with high rates of reported anaphylaxis. These reports illustrate the susceptibility of supposedly objective medical judgments to public anxiety. PURPOSE AND METHODS: This study documents inaccuracies in reported AEFIs using three quantitative methods. RESULTS: One of these quantitative methods revealed that false-positive rates for anaphylaxis reports following HPV and later COVID-19 vaccination ranged from 74 to 91 percent. However, unlike HPV vaccinations in Japan, anaphylaxis reports following COVID-19 vaccines fell in Japan, the USA and the UK in the latter months of 2021. Nevertheless, false-positive rates for anaphylaxis reports remained high, suggesting a high degree of imprecision in serious AEFI reports from many countries for many vaccines. Japan's HPV immunization program indicates that media reports, patient hesitancy, healthcare providers' perspectives on vaccine safety, and consistency of government messaging, all influence report number and accuracy. A parallel publication analyzes in depth how such factors affect AEFI reports. CONCLUSION: Confidence in the safety of the COVID-19 vaccines may have been bolstered trough rapid monitoring of AEFI reports and communication of these findings. This may partly explain the different trajectories of serious AEFI following HPV immunizations in Japan and COVID-19 immunizations in the USA, UK, and Japan.

Vaccination against COVID-19.

Vaccination is essential to manage the COVID-19 pandemic. Vaccination significantly protects against severe COVID-19, hospitalization and death;it also protects against symptomatic infection and reduces the risk of transmission to other people. Protection against the new SARS-CoV-2 variants may be lower, but protection against severe course and death remains high. Two mRNA vaccines (BNT162b2 and mRNA-1273) and two vector vaccines (AZD1222 and Ad26.COV2.S) are currently available in the Czech Republic. Vaccination of persons over 60 years of age and immunocompromised persons, who are demonstrably at the highest risk of a serious course of the disease, is of the utmost importance. In order to achieve adequate vaccination coverage, it is necessary to motivate other groups of people to be vaccinated, including children over 12 years of age and young adults. Vaccination is also recommended in preg-nant women in the 2nd and 3rd trimesters and in breastfeeding women. For selected groups of vaccines, a third dose of vaccination is recommended (additional third dose 4 weeks after the second dose or a booster dose 8 to 12 months after the second dose). The side effects are usually mild, with serious complications (including anaphylaxis, thrombocytopenia with thrombosis syndrome, myocardi-tis, Guillain-Barre syndrome and capillary leak syndrome) being rare.Copyright © 2021, Trios spol. s.r.o.. All rights reserved.

Anaphylaxis to Cyclophosphamide Metabolites during Lymphodepletion for CAR-T Therapy

Background: Cyclophosphamide (Cy) is used in hematopoietic stem cell transplant (HSCT) preparative regimens and lymphodepletion for chimeric antigen receptor T-cell (CAR-T) therapy. We describe a case of cyclophosphamide hypersensitivity in a pediatric patient during CAR-T therapy. Case description: A 13 year old boy was diagnosed with very high risk ALL in 2015 and had 2 isolated CNS relapses treated with intensified chemotherapy (chemo) and cranial radiation (1st relapse) and Blinatumomab with intrathecal (IT) chemo followed by sibling donor HSCT (2nd relapse). At age 19, and 18 months after HSCT, he had a 3rd CNS relapse treated with IT chemo and referral for CAR-T therapy. At our center, leukapheresis and CAR-T production (Novartis) were performed. Later, during lymphodepletion with fludarabine (Flu) and Cy, physiologic replacement hydrocortisone (HC) was briefly held to prevent interference with CAR-T function. After 3 days of Flu/Cy, he developed fever and hypotension requiring inotropic support. Hypotension and fever resolved with stress dose HC and antibiotics and was attributed to culture-negative sepsis and adrenal crisis. CAR-T infusion was subsequently delayed by skin GVHD requiring glucocorticoids and COVID-19 infection treated with convalescent plasma and nirmatrelvir/ritonavir. Physiologic HC replacement was continued when he was re-admitted for CAR-T therapy, but he again developed fever, diffuse erythema and shock in hours following the first dose of Cy necessitating stress dose HC, antibiotics, inotropes, and mechanical ventilation. Negative blood cultures and ongoing physiologic HC replacement suggested an alternative explanation for shock. Case reports of anaphylaxis to Cy metabolites implicated Cy as the causative agent so it was discontinued. After recovery, CAR-T cells were infused without complications. In the following weeks, he had no evidence of recurrent leukemia but was persistently pancytopenic. A sibling donor stem cell boost was proposed but the patient accepted only palliative care. He had several opportunistic infections before succumbing to E. coli sepsis. Discussion(s): The first episode of shock was initially attributed to adrenal crisis and sepsis, although no organism was identified. The second episode appeared anaphylactic in timing and clinical presentation with adequate HC replacement and negative cultures, suggesting Type I hypersensitivity. The patient previously received Cy uneventfully before HSCT, suggesting that the donor-derived immune system was the source of new Cy hypersensitivity. Onset of anaphylaxis within hours rather than minutes after Cy administration supports hypersensitivity to Cy metabolites rather than to the drug itself. This case highlights the importance of consideration of sensitivity to Cy metabolites as well as acquired donor-specific allergy even when alternative explanations are likely.Copyright © 2023 American Society for Transplantation and Cellular Therapy

Evaluation of association of anti-PEG antibodies with anaphylaxis after mRNA COVID-19 vaccination.

BACKGROUND: The mechanism for anaphylaxis following mRNA COVID-19 vaccination has been widely debated; understanding this serious adverse event is important for future vaccines of similar design. A mechanism proposed is type I hypersensitivity (i.e., IgE-mediated mast cell degranulation) to polyethylene glycol (PEG). Using an assay that, uniquely, had been previously assessed in patients with anaphylaxis to PEG, our objective was to compare anti-PEG IgE in serum from mRNA COVID-19 vaccine anaphylaxis case-patients and persons vaccinated without allergic reactions. Secondarily, we compared anti-PEG IgG and IgM to assess alternative mechanisms. METHODS: Selected anaphylaxis case-patients reported to U.S. Vaccine Adverse Event Reporting System December 14, 2020-March 25, 2021 were invited to provide a serum sample. mRNA COVID-19 vaccine study participants with residual serum and no allergic reaction post-vaccination ("controls") were frequency matched to cases 3:1 on vaccine and dose number, sex and 10-year age category. Anti-PEG IgE was measured using a dual cytometric bead assay (DCBA). Anti-PEG IgG and IgM were measured using two different assays: DCBA and a PEGylated-polystyrene bead assay. Laboratorians were blinded to case/control status. RESULTS: All 20 case-patients were women; 17 had anaphylaxis after dose 1, 3 after dose 2. Thirteen (65 %) were hospitalized and 7 (35 %) were intubated. Time from vaccination to serum collection was longer for case-patients vs controls (post-dose 1: median 105 vs 21 days). Among Moderna recipients, anti-PEG IgE was detected in 1 of 10 (10 %) case-patients vs 8 of 30 (27 %) controls (p = 0.40); among Pfizer-BioNTech recipients, it was detected in 0 of 10 case-patients (0 %) vs 1 of 30 (3 %) controls (p >n 0.99). Anti-PEG IgE quantitative signals followed this same pattern. Neither anti-PEG IgG nor IgM was associated with case status with both assay formats. CONCLUSION: Our results support that anti-PEG IgE is not a predominant mechanism for anaphylaxis post-mRNA COVID-19 vaccination.

Identifying and Managing Those at Risk for Vaccine-Related Allergy and Anaphylaxis.

Immediate hypersensitivity reactions to vaccines, the most severe of which is anaphylaxis, are uncommon events occurring in fewer than 1 in a million doses administered. These reactions are infrequently immunoglobulin E-mediated. Because they are unlikely to recur, a reaction to a single dose of a vaccine is rarely a contraindication to redosing. This narrative review article contextualizes the recent knowledge we have gained from the coronavirus 2019 (COVID-19) pandemic rollout of the new mRNA platform with the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines within the much broader context of what is known about immediate reactions to other vaccinations of routine and global importance. We focus on what is known about evidence-based approaches to diagnosis and management and what is new in our understanding of mechanisms of immediate vaccine reactions. Specifically, we review the epidemiology of immediate hypersensitivity vaccine reactions, differential diagnosis for immune-mediated and nonimmune reaction clinical phenotypes, including how to recognize immunization stress-related responses. In addition, we highlight what is known about mechanisms and review the rare but important contribution of excipient allergies and specifically when to consider testing for them as well as other key features that contribute to safe evaluation and management.

COVID-19 vaccines safety: Spontaneous notification data

Introduction (contexte de la recherche): Although the SARS-CoV-2 vaccines have undergone preclinical tests and clinical trials evaluating their efficacy and safety, few data have been reported in the post-licensure real-world setting. Objectif: We aimed to assess the safety of COVID-19 vaccines among a Tunisian Pharmacovigilance database. Methodes: An exhaustive observational study including all adverse events following COVID-19 vaccination notified to the pharmacovigilance unit of the Monastir Hospital. Resultats: A total of 336 events were collected. The patients' sex ratio was 1.4. Elderly patients (>= 65-years-old) represented 54% of cases. The most common adverse reaction was fatigue and fever (30%, respectively), followed by headache (21%), muscle soreness (15%) and localized pain at the injection site (13%). Skin eruptions accounted for 14% of the reported events and anaphylaxis was noted in 0.6% of cases. The most reported events were mild. However, 15 patients developed serious events [anaphylaxis (seven cases), thrombotic reactions (seven cases), and thrombocytopenia (one case)]. The event was fatal in five patients. Pfizer-BioNTech vaccine was implicated in 65% of reported events, followed by AstraZeneca vaccine (11%). Pfizer-BioNTech vaccine was implicated in 9/15 serious events. Fatal events were observed with Pfizer-BioNTech vaccine in three cases, and AstraZeneca and CoronaVac vaccines in one case each. Conclusion(s): Our study implies that the COVID-19 vaccines have a favorable safety profile due to the low incidence of self-reported adverse reactions. Further large-scale studies are needed to confirm the safety of COVID-19 vaccines.Copyright © 2023

Covid-19 vaccines safety: Spontaneous notification data

Background: Although the SARS-CoV- 2 vaccines have undergone preclinical tests and clinical trials evaluating their efficacy and safety, few data have been reported in the post-licensure real-world setting. We aimed to assess the safety of Covid-19 vaccines among a Tunisian Pharmacovigilance database. Method(s): An exhaustive observational study including all adverse events following Covid-19 vaccination notified to the pharmacovigilance unit of the Monastir Hospital from April to December 2021. Result(s): A total of 336 events were collected. The patients' sex ratio was 1.4. Elderly patients (>=65 years old) represented 54% of cases. The most common adverse reaction was fatigue and fever (30%, respectively), followed by headache (21%), muscle soreness (15%) and localized pain at the injection site (13%). Skin eruptions accounted for 14% of the reported events and anaphylaxis was noted in 0.6% of cases. The most reported events were mild. However, 15 patients developed serious events (anaphylaxis (seven cases), (thrombotic reactions (seven cases), and thrombocytopenia (one case)). The event was fatal in five patients. Pfizer-BioNTech vaccine was implicated in 65% of reported events, followed by AstraZeneca vaccine (11%). Pfizer-BioNTech vaccine was implicated in 9/15 serious events. Fatal events were observed with Pfizer-BioNTech vaccine in three cases, and AstraZeneca and CoronaVac vaccines in one case each. Conclusion(s): Our study implies that the Covid-19 vaccines have a favorable safety profile due to the low incidence of self-reported adverse reactions. Further large-scale studies are needed to confirm the safety of Covid-19 vaccines.

Allergological study in patients referred for adverse reactions to the SARS CoV2 vaccine: Our experience

Background: Adverse reaction's reported after COVID 19 vaccination had a negative impact on public opinion. These adverse reactions may be or may be not be mediated by hypersensibility reactions. The proper assesment and the manegament of adverse reactions are crucial in order to offer a safer inmunitation and also to reduce the misinformation and the growing rejection to COVID 19 vaccination. Objective(s): To describe clinical characteristics and the allergological study done in different patients who had an adverse event right after COVID 19 vaccine administration Method: Descriptive study in patients who have experienced an adverse event after one single dose of the SARS CoV2's vaccine. Sex, age, atopy, drug allergies, anaphylaxis reaction (according to EEACI), syntoms, timing, vaccine and dose are described on this study. Skin test were done in every patient (Prick-Test and intradermo reaction) with ARN vaccine samples (Pfizer and Moderna), Adenovirus vaccine extract (Astrazeneca) and a battery of excipients (Polietilenglicol, Polisorbato80 and Trometamol). Result(s): The study included 44 patients with an average of 48,76 +/- 12,23 years, (93% women-29% atopic). 29% of the patients reported to be allergic to other drugs (AINES especially). The most frequent reaction according to EEACI anaphilaxy's classification was Grade 1 with a 61%. Grade 2: 18%, Grade 3: 21%. Urticaria and/or angioedema were the most frequent syntoms (60%) followed by disnea (20%) and being late syntoms (50%) the most usual ones. Pfizer was the most implicated vaccine (64%) with the first dose (84%). Skin tests with Polietilenglicol, Trometamol and Polisorbato80 at different concentrations were negative in all patients but two, one positive to Polisorbato80 0.004mg/ml with a previous sensitization to Prontosan (contains Polisorbato) and another one positive to Trometamol 0.1mg/ml. Conclusion(s): Allergists play a main role to offer the maximum befenits to their patients and to improve the vaccine's safety. Skin tests were the most efective tool to diagnose hypersensibility reactions. The 93,17% of the patients with a negative test result tolerated the second dose. The others did not get the second dose due to their own will. Avoiding the COVID 19 vaccine was recommended in those patients with a hypersensibility to the vaccine components diagnose.

Insights from a COVID-19 in-person vaccination program operated in an Allergy department over 13 months

Background: The Spanish COVID-19 vaccination program commenced in December 2020. Some patients were excluded due to background pathologies, ever changing vaccination protocols and the risk of the secondary effects. Some were allergy patients with previous non-vaccine- related anaphylactic episodes, mastocytosis, and food or drug allergies. There were concerns that patients with secondary effects after the first or second doses would be reluctant to have further doses. The Allergy department at the Hospital Universitario Central de Asturias created a COVID-19 pre-and post-vaccination in-person program in which allergy excipient testing and vaccination were carried out when necessary. As far as we are aware, this is the first ever allergy-led testing and vaccination centre protocol of this kind. Method(s): 110 consecutive patients received at least one vaccine dose under the program in the Allergy Department from January 2021 to February 2022. Result(s): Females were more likely to be referred to the Allergy Department (90% of the total). The mean patient age was 53 years and ranged from 18 to 92 years. 27% were existing patients referred internally by the Allergy department, with the remainder from elsewhere. Angioedema (9%), mastocytosis (4%) and anaphylaxis (17%) were some of the patients' preconditions. A third of patients had two or more doses administered in the department. 61% of patients who received one dose of vaccine in the Allergy department went on to complete the full vaccination course as per national Spanish protocol. Only 16% could not continue with immunizations due to a severe allergic reaction to their first or second doses. None of the patients in the Allergy department program required emergency care after vaccination. Conclusion(s): The majority of patients at high risk of secondary effects were able to complete their vaccination course after the Allergy department input. The Allergy department can work as a successful vaccination centre when required.

Online medical consultations and Covid-19 Vaccines in allergic patients

Background: Anaphylaxis reports after Covid-19 vaccination caused concerns regarding adverse effects. Many allergic patients demanded assurances by their allergists. Online Medical Consultations (OMC) are a communication tool between Primary Care and Allergy Department in Navarre. We assessed the impact of allergists' advice regarding Covid-19 vaccination in allergic patients, defined by vaccination status after OMC, and compared reported allergy severity between vaccinated and non-vaccinated. Method(s): Retrospective review of Allergy OMC and vaccination records of patients attended between 2020th September and 2021th August. We screened Covid-19 related OMC and selected those related with possible contraindications/specific recommendations before vaccination (BV).We analysed demographics, vaccination status, allergic diseases (green: non-anaphylactic allergy;yellow: anaphylaxis/ severe drug allergy;red: severe allergy to Covid-19 vaccine or related drug/excipients;blue: non-immunologic symptoms) and OMC replies (contraindication or other recommendations) Results: We received 1438 OMC, 422 due to Covid-19 vaccine and analysed 302 (71.6%), concerning BV. Demographics: Age (median, P25-P75) 61 (46.7-72.25) years. Sex: Female 221 (73.2%);Male 81 (26.8%). Vaccination: 275 (91.1%) completed vaccination (CV) (2 doses), 11 (3.6%) received 1 (IC) and 16 patients (5.3%) none (NC). Specific preparations were contraindicated in 28 (9.4%) (Pfizer-Biontech : 17, Astra-Zeneca 3 and Moderna: 8 cases). Recommendations: 30-minute observation 18.2%;45-minute observation 14.6%;antihistamines 2.6%;time interval with other injectables 1%;alternative vaccine 2.3%;other modifications 1%;premedication and observation period (2.3%). Ten patients (3.3%) required another OMC after adverse events during vaccination. Allergy severity was different according to sex (Male: green 59.2%, yellow 38.2%, red 0%;blue 2.46%;Female: green: 60.2%, yellow 31.8%, red 9.9%, blue: 4.5% (p = 0.025)). Comparison of allergies between groups: CV (Green: 60.7%, yellow: 33.4%, red: 2.9%, blue: 1%);IC (Green: 27%;yellow: 63.6% red: 0%, blue: 9%);NC (Green: 68.75%, yellow: 12.5%, red: 0%, blue: 18.75% (p = 0.03)) Conclusion(s): Adherence to OMC recommendations has been excellent in these patients. Differences in the number of OMC according to sex appear related to previous allergy diagnosis. Observed differences in past allergic diseases according to vaccination status are not related to real contraindications.