ABSTRACT
PURPOSE OF REVIEW: A known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine is the only contraindication to coronavirus disease 2019 (COVID-19) mRNA vaccination. It is important for pediatricians to understand the likelihood of an allergic reaction to COVID-19 mRNA vaccines, including its excipients. RECENT FINDINGS: Episodes concerning for anaphylaxis were immediately reported following early administration of COVID-19 mRNA vaccines to adults. Although allergic type symptoms were reported equally in recipients of placebos and test vaccines in phase 3 clinical trials, post-authorization prospective studies state that 0.2-2% of vaccine recipients have experienced allergic reactions. Subsequent allergy testing of affected individuals has focused largely on evaluation of allergic sensitization to a novel vaccine excipient, polyethylene glycol (PEG). PEG is a polymer incorporated in numerous pharmaceutical products because of its favorable, inert properties. The results of allergy testing in adults to date indicate that IgE mediated anaphylaxis to PEG allergy is rarely identified after COVID-19 mRNA vaccine reactions. Numerous individuals with presumed anaphylaxis have tolerated a second vaccine after evaluation and testing by an allergist, suggesting either misdiagnosis or a novel immune mechanism. SUMMARY: Confirmed anaphylactic reactions to COVID-19 mRNA vaccines are rare, likely due to a lack of preexisting IgE against the vaccine components, including PEG.
Subject(s)
Anaphylaxis , COVID-19 , Adult , Anaphylaxis/chemically induced , Anaphylaxis/diagnosis , COVID-19 Vaccines , Humans , Prospective Studies , RNA, Messenger , SARS-CoV-2ABSTRACT
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.
Subject(s)
Anaphylaxis , COVID-19 Vaccines , COVID-19 , Female , Humans , Male , Adverse Drug Reaction Reporting Systems , COVID-19/epidemiology , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , Drug-Related Side Effects and Adverse Reactions , Europe/epidemiologyABSTRACT
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.
Subject(s)
Anaphylaxis , COVID-19 Vaccines , COVID-19 , Papillomavirus Infections , Papillomavirus Vaccines , Humans , Adverse Drug Reaction Reporting Systems , Anaphylaxis/chemically induced , COVID-19/epidemiology , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , Immunization/adverse effects , Japan/epidemiology , Papillomavirus Infections/chemically induced , Papillomavirus Infections/prevention & control , Papillomavirus Vaccines/adverse effects , United Kingdom/epidemiology , Vaccination/adverse effects , Vaccination HesitancyABSTRACT
mRNA vaccines, particularly, have been associated with an increased risk of allergic reactions and rarely anaphylaxis. Although rare, vaccine reactions can cause significant anxiety and fear in the population, leading to indecision and vaccine refusal. This study aimed to retrospectively evaluate the role of polyethylene glycol (PEG) sensitivity in vaccination decision-making in pediatric patients at high risk of allergy or with suspected allergic reactions to the first dose of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) vaccine. Seventeen enrolled patients were found to have decreased readiness to receive the Coronavirus Disease 2019 (COVID-19) vaccine after developing hypersensitivity to multiple and/or injectable drugs. Skin testing was performed. A basophil activation test with PEG-2000 and 4000 was performed on three patients who were ineligible for skin prick tests. Nine patients with negative tests received the vaccine without complications. One patient had urticarial angioedema despite negative tests. Three patients with positive tests did not agree to desensitization with the mRNA vaccine, and one of them was vaccinated with the inactivated COVID-19 vaccine. Four patients recurred despite negative tests. The general recommendation for patients describing severe reactions to drugs, foods, and allergens, such as toxins that do not contain the adjuvants of the SARS-CoV-2 vaccines, is to be routinely vaccinated with safety precautions. Excipients such as PEG and polysorbate-80 used in COVID-19 vaccines could be potential allergens, but this hypothesis is unclear. The predictive values of these adjuvants for skin testing and in vitro testing are controversial. Further research is needed on the hypersensitivity reactions of adjuvants, the predictive values of skin tests, and etiopathogenesis.
Subject(s)
Anaphylaxis , COVID-19 Vaccines , COVID-19 , Child , Humans , Adjuvants, Immunologic , Anaphylaxis/diagnosis , Anaphylaxis/etiology , COVID-19/prevention & control , COVID-19 Vaccines/administration & dosage , Polyethylene Glycols/adverse effects , Polysorbates/adverse effects , Retrospective Studies , RNA, Viral , SARS-CoV-2 , VaccinationABSTRACT
BACKGROUND: Messenger RNA coronavirus disease 2019 (COVID-19) vaccines have been associated with allergic reactions. A history of anaphylaxis has been suggested as a risk factor for such reactions. Polyethylene glycol (PEG) has been proposed as a possible culprit allergen. OBJECTIVE: To investigate possible PEG or polysorbate allergy among patients reporting prior reactions to COVID-19 vaccines or PEG and to report their subsequent tolerance of COVID-19 vaccines. METHODS: From January 1, 2021, to October 31, 2021, adult patients referred to the McGill University Health Centre allergy clinics who were considered at risk of anaphylaxis were prospectively recruited. The entry criteria were any documented history of reaction to a COVID-19 vaccine or reported allergy to PEG or polysorbate. Evaluated patients underwent skin prick testing (SPT) with PEG and polysorbate. After SPT, placebo-controlled vaccine challenges were carried out. RESULTS: Of the 44 patients recruited, 40 (90.1%) had reacted to the first vaccine dose, with 18 (45%) of them had anaphylactic reaction. All patients underwent SPT and 5 (11.3%) had a positive test result. A total of 39 patients (88.6%) underwent COVID-19 vaccine challenge at the allergy clinic. Most tolerated the vaccine, with 18 (40.1%) received a single full dose, 20 (45.4%) 2 split doses, and 6 (13.6%) a graded dosing protocol. Of the 40 patients who reacted to the first dose, 2 had immediate nonsevere allergic reactions to the second dose. CONCLUSION: In this cohort of patients with a history of anaphylaxis and increased risk of allergic reactions to the COVID-19 vaccines, after allergist evaluation, including negative PEG skin testing result, the vaccine was safely administered without any serious adverse events.
Subject(s)
Anaphylaxis , COVID-19 Vaccines , Adult , Anaphylaxis/chemically induced , COVID-19/epidemiology , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , Humans , UniversitiesABSTRACT
BACKGROUND: The Pfizer-BioNTech® BNT162b2 vaccine, provides 95% effectiveness from the second dose onwards. The reported rate of anaphylaxis to COVID-19 vaccines is 4.7 cases/million doses administered. CASE REPORT: 30-year-old female, health professional, history of allergic rhinitis, asthma, reaction to eye cosmetics and adhesive tape: erythema, edema, and local pruritus. Immediately after application of the first dose of Pfizer-BioNTech vaccine, she presented grade III anaphylaxis. The patient was stratified, phenotyped and skin tests with PEG 3350 were positive. A recommendation was issued not to reapply vaccine containing polyethylene glycol and alternatives were offered. CONCLUSIONS: An adequate risk stratification should be performed before applying mRNA-based COVID-19 vaccines for the first time in at-risk groups. In case of anaphylaxis at the first dose, phenotyping and further study with PEG skin tests should be performed and vaccination alternatives should be offered.
INTRODUCCIÓN: La vacuna Pfizer-BioNTech® BNT162b2 proporciona efectividad del 95% a partir de la segunda dosis. La tasa de anafilaxia reportada de vacunas para COVID-19 es de 4.7 casos por millón de dosis administradas. REPORTE DEL CASO: Paciente femenina de 30 años, profesional de la salud, con antecedentes de rinitis alérgica, asma, reacción a productos cosméticos en los párpados y al pegamento de la cinta adhesiva (eritema, edema y prurito local). Posterior a la aplicación de la primera dosis de la vacuna Pfizer-BioNTechÒ tuvo un evento de anafilaxia grado III. Se estratificó, fenotipificó y efectuaron pruebas cutáneas con PEG-3350, que resultaron positivas. Se sugirió no aplicar la aplicar vacuna de refuerzo que contuviera polietilenglicol y se ofrecieron alternativas de tratamiento. CONCLUSIONES: Es importante efectuar la adecuada estratificación de riesgo antes de aplicar las vacunas para COVID-19 basadas en ARNm por primera vez. En caso de anafilaxia es necesario fenotipificar y ampliar el estudio con pruebas cutáneas con PEG, además de otorgar alternativas de vacunación.
Subject(s)
Anaphylaxis , COVID-19 Vaccines , COVID-19 , Vaccines , Adult , Female , Humans , Anaphylaxis/diagnosis , Anaphylaxis/etiology , BNT162 Vaccine , COVID-19 Vaccines/adverse effectsSubject(s)
Anaphylaxis , Vaccines , Humans , Anaphylaxis/prevention & control , Canada/epidemiology , Public Policy , Health PolicyABSTRACT
Even though the SARS-CoV-2 pandemic represents a historical challenge, science has had an exponential development, and the current vaccination campaigns are proof of this. Unfortunately, along came misinformation and myths regarding their production and their adverse effects. For this reason, we have considered of utter importance to review anaphylaxis, one of the most feared vaccine adverse events.Anaphylaxis can be defined as a life-threatening acute and systemic allergic reaction, with a wide clinical spectrum, which can be explained by many immunological mechanisms, and whose diagnostic complexity demands the fulfillment of strict criteria. Though infrequent, any vaccine has the potential to trigger anaphylaxis. In the United States, for the new SARS-CoV-2 vaccines, rates from 1:200 000 (Pfizer-BioNTech) to 1:360 000 doses (Moderna) have been estimated. Vaccine adverse events can be mediated by hypersensitivity reactions, either allergic or not. Unlike a typical drug allergy, rarely is the active ingredient responsible for the reaction. Therefore, excipients must be considered during the approach to this problem. Vaccine associated anaphylaxis has to be referred to an allergist so as to guarantee the maximum benefit for the patient and improve the vaccines' security profile.
A pesar de la difícil situación que se enfrenta con la actual pandemia de COVID-19, la ciencia ha tenido un desarrollo exponencial. Si bien la inmunización contra esa enfermedad ha sido posible gracias a ello, desafortunadamente se ha acompañado de desinformación y mitos en torno a su fabricación y reacciones adversas. Por tal razón, es importante revisar una de las reacciones adversas a vacunas más temidas para el personal de salud y la población general, la anafilaxia. La anafilaxia se define como una reacción alérgica aguda y sistémica que puede poner en riesgo la vida; se asocia con distintos mecanismos inmunológicos, factores desencadenantes y manifestaciones clínicas. Su diagnóstico puede ser confuso, por lo que se han establecido diferentes criterios. Todas las inmunizaciones tienen el potencial de desencadenar anafilaxia, aunque este evento es poco frecuente. Respecto de las vacunas contra el coronavirus SARS-CoV-2, en Estados Unidos se ha reportado una tasa de anafilaxia de 1:200 000 para la vacuna Pfizer-BioNTech, y de 1:360 000 para la vacuna de Moderna. Al igual que un fármaco, las vacunas pueden presentar efectos adversos mediados por mecanismos de hipersensibilidad, pero a diferencia de lo que sucede con los medicamentos, el principio activo rara vez es el responsable; es más frecuente que las reacciones indeseadas se deban a los excipientes. La sospecha de una anafilaxia secundaria a su aplicación obliga a una oportuna referencia y a un correcto diagnóstico, tanto para el beneficio del paciente como para mejorar el perfil de seguridad de la vacuna.
Subject(s)
Anaphylaxis , COVID-19 , Vaccines , Anaphylaxis/chemically induced , COVID-19 Vaccines , Humans , SARS-CoV-2 , United States , Vaccines/adverse effectsABSTRACT
BACKGROUND: Bamlanivimab and etesevimab had been granted emergency use authorization in children under 12 years who are at risk of progression from mild/moderate coronavirus disease 2019 to severe disease and hospitalization. CASE REPORT: We report on a 5-year-old white male with preexisting conditions, predisposing him to severe disease, who developed hypoxia and flushing 3 minutes into his infusion, thus meeting the criteria for anaphylaxis. CONCLUSIONS: We believe this patient developed either an immunoglobulin E-mediated anaphylactic or a non-immunoglobulin E-mediated anaphylactoid reaction to bamlanivimab and etesevimab, which is an important possibility to consider on administration.
Subject(s)
Anaphylaxis , COVID-19 , Male , Child , Humans , Child, Preschool , Antibodies, Monoclonal , HospitalizationABSTRACT
AIM: The present study aimed to estimate the anaphylaxis rates following mRNA COVID-19 vaccination in children and adolescents in Europe. METHODS: We retrieved data on 371 anaphylaxis cases following mRNA COVID-19 vaccination in children ≤ 17 years old notified to EudraVigilance as of October 8, 2022. Overall, 27,120,512 doses of BNT162b2 vaccine and 1,400,300 doses of mRNA-1273 vaccine have been delivered to children during the study period. RESULTS: The overall mean anaphylaxis rate was 12.81 [95% confidence interval (CI): 11.49-14.12] per 106 mRNA vaccine doses [12.14 (95% CI: 6.37-17.91) per 106 doses for mRNA-1273 and 12.84 (95% CI: 11.49-14.19) per 106 doses for BNT162b2]. Children 12-17 years old accounted for 317 anaphylaxis cases, followed by 48 cases in children 3-11 years old, and 6 cases in children 0-2 years old. Children 10-17 years old had a mean anaphylaxis rate of 13.52 (95% CI: 12.03-15.00) cases per 106 mRNA vaccine doses and children 5-9 years old had a mean anaphylaxis rate of 9.51 (95% CI: 6.82-12.20) cases per 106 mRNA vaccine doses. There were two fatalities, both in the 12-17 years age group. The fatal anaphylaxis rate was 0.07 cases per 106 mRNA vaccine doses. CONCLUSIONS: Anaphylaxis is a rare adverse event after receiving an mRNA COVID-19 vaccine in children. Continuous surveillance of serious adverse events is needed to guide vaccination policies as we move towards SARS-CoV-2 endemicity. Larger real-world studies on COVID-19 vaccination in children, using clinical case confirmation, are imperative.
Subject(s)
Anaphylaxis , COVID-19 , Humans , Adolescent , Child , Child, Preschool , Infant, Newborn , Infant , Anaphylaxis/chemically induced , Anaphylaxis/epidemiology , 2019-nCoV Vaccine mRNA-1273 , BNT162 Vaccine , COVID-19/epidemiology , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , SARS-CoV-2 , Vaccination/adverse effects , RNA, MessengerABSTRACT
BACKGROUND: Anaphylaxis is an often under =diagnosed, severe allergic event for which epidemiological data are sporadic. Researchers have leveraged administrative and claims data algorithms to study large databases of anaphylactic events; however, little longitudinal data analysis is available after transition to the International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM). OBJECTIVE: Study longitudinal trends in anaphylaxis incidence using direct and indirect query methods. METHODS: Emergency department (ED) and inpatient data were analyzed from a large state health care administration database from 2011 to 2020. Incidence was calculated using direct queries of anaphylaxis ICD-9-CM and ICD-10-CM codes and indirect queries using a symptom-based ICD-9-CM algorithm and forward mapped ICD-10-CM version to identify undiagnosed anaphylaxis episodes and to assess algorithm performance at the population level. RESULTS: An average of 2.4 million inpatient and 7.5 million ED observations/y were analyzed. Using the direct query method, annual ED anaphylaxis cases increased steadily from 1,454 (2011) to 4,029 (2019) then declined to 3,341 in 2020 during the coronavirus disease 2019 (COVID-19) pandemic. In contrast, inpatient cases remained relatively steady, with a slight decline after 2015 during the ICD version transition, until a significant drop occurred in 2020. Using the indirect queries, anaphylaxis cases increased markedly after the ICD transition year, especially involving drug-related anaphylaxis. CONCLUSIONS: Nontypical drug associations with anaphylaxis episodes using the ICD-10-CM version of the algorithm suggest poor performance with drug-related codes. Further, the increased granularity of ICD-10-CM identified potential limitations of a previously validated symptom-based ICD-9-CM algorithm used to detect undiagnosed cases.
Subject(s)
Anaphylaxis , COVID-19 , Humans , Anaphylaxis/diagnosis , Anaphylaxis/epidemiology , International Classification of Diseases , COVID-19/epidemiology , Emergency Service, Hospital , AlgorithmsABSTRACT
Sentinel lymph node biopsy (SLNB) is the standard of care for staging the clinically node-negative axilla in early breast cancer. Evidence guiding current practice describes dual localization technique using Patent blue dye and radioisotope (99mTc). Adverse effects of blue dye include 1:1000 risk of anaphylaxis, skin staining and loss of plane visibility, which may increase operative time and reduce resectional accuracy. The risk to a patient posed by anaphylaxis may be greater when operating in a unit without on-site ITU support - a situation more common with recent restructuring during the COVID-19 pandemic. Aim is to quantify the benefit of blue dye above radioisotope alone in identifying nodal disease. This is a retrospective analysis of prospectively collected sentinel node data including all consecutive sentinel node biopsies in a single center during the period 2016-2019.In terms of results, 760 sentinel nodes were taken in 435 patients. 59 nodes (7.8%) were detected by blue dye alone; 120 (15.8%) 'hot' only, 581 (76.5%) hot and blue. 4 of the blue only nodes contained macrometastases but 3 of these patients had further hot nodes excised that also contained macrometastases. 1 out of 435 patients (0.2%) had macro metastatic disease identified as a result of blue dye alone which would have been missed had it not been used. In conclusion, the use of blue dye carries risk and offers little benefit in terms of staging in SLNB and its use may be unnecessary in the hands of the skilled surgeon. This study supports the omission of blue dye, which may be advisable if operating in units without ITU support. If larger studies support these figures, it may become as outdated.
Subject(s)
Anaphylaxis , Breast Neoplasms , COVID-19 , Humans , Female , Sentinel Lymph Node Biopsy , Axilla , Pandemics , Retrospective StudiesABSTRACT
BACKGROUND: Vaccination of the population is required to combat the COVID-19 pandemic. Allergy testing could reduce anxiety towards COVID-19 vaccination and thereby may increase vaccination rate, however, its effectiveness remains unclear. METHODS: One hundred and thirty prospective real-life patients in need of but not daring to get vaccinated asked for allergy workup for COVID-19 vaccine hypersensitivity in 2021/2022. Characterization of patients, identification of anxieties, decrease of patient's anxiety levels, overall vaccination rate and adverse reactions after vaccination were assessed. RESULTS: Tested patients were characterized by being female (91.5%) and having a high rate of previous allergies (e.g. to food 55.4%, drugs 54.6%, or previous vaccinations 50%) and dermatological disease (29.2%) but not always had medical contraindications for COVID-19 vaccination. Sixty one patients (49.6%) were highly concerned (4-6, Likert scale 0-6) about vaccination and 47 (37.6%) expressed resolving thoughts about vaccinaion anaphylaxis (3-6, Likert scale 0-6). However only 35 patients (28.5%) were scared of getting COVID-19 within 2 months (4-6, Likert scale 0-6) and only 11 (9%) patients had high expectations of getting COVID-19 (4-6, Likert scale 0-6). Allergy testing significantly (p < 0.01 to p < 0.05 respectively) reduced the median anxiety of allergic symptoms following vaccination: dyspnoea (4.2-3.1), to faint (3.7-2.7), long-term consequences (3.6-2.2), pruritus (3.4-2.6), skin rash (3.3-2.6) and death (3.2-2.6). After allergy testing, most patients (108/122, 88.5%) let themselves be vaccinated within 60 days. Revaccinated patients with previous symptoms experienced a reduction of symptoms (p < 0.05) upon revaccination. CONCLUSIONS: Patients not daring to get vaccinated have more anxiety towards vaccination than to acquire COVID-19. For those, allergy testing excludes vaccine allergy, and is a tool to increase vaccination willingness and thereby helps to combat vaccination hesitancy.
Subject(s)
Anaphylaxis , COVID-19 Vaccines , COVID-19 , Female , Humans , Male , COVID-19/epidemiology , COVID-19/prevention & control , COVID-19 Vaccines/administration & dosage , COVID-19 Vaccines/adverse effects , Pandemics , Prospective Studies , VaccinationABSTRACT
Within the first 4 months of the Western Australian COVID-19 immunisation programme, 49 suspected anaphylaxis cases were reported to the vaccine safety surveillance system. Twelve reports met Brighton Collaboration case definition, corresponding to rates of 15.9 and 17.7 per million doses of Vaxzevria and Comirnaty administered respectively.
Subject(s)
Anaphylaxis , COVID-19 Vaccines , COVID-19 , Humans , Adverse Drug Reaction Reporting Systems , Anaphylaxis/etiology , Australia/epidemiology , BNT162 Vaccine , ChAdOx1 nCoV-19 , COVID-19/etiology , COVID-19 Vaccines/adverse effects , Vaccination/adverse effects , Western AustraliaABSTRACT
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 excipient 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. Anti-PEG IgG and IgM were measured using two different assays. 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>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.
Subject(s)
Anaphylaxis , Drug Hypersensitivity , Hypersensitivity, Immediate , COVID-19ABSTRACT
Although rare in Portugal, snakebite envenoming entails severe morbidity and mortality. We present the case of a 65-year-old woman bitten on her leg in a northern coastal region in Portugal, on a walk during the COVID-19 pandemic lockdown. Despite first looking for help at the nearest pharmacy, she developed anaphylactoid shock and was promptly driven to a tertiary hospital, where antivenom was administered in a timely manner under close monitoring. Prophylactic antibiotics were started and maintained based on elevated inflammatory markers and signs of wound inflammation. She evolved favorably, with rapid weaning of vasopressors and resolution of end-organ dysfunction. This case highlights the importance of prompt recognition and describes crucial steps in envenomation management in a country where snakebite is infrequent, but potentially fatal.
Subject(s)
Anaphylaxis/epidemiology , Anaphylaxis/etiology , Snake Bites/complications , Snake Bites/epidemiology , Aged , Anaphylaxis/therapy , Anti-Bacterial Agents/administration & dosage , Antivenins/administration & dosage , Ceftriaxone/administration & dosage , Clindamycin/administration & dosage , Female , Humans , Portugal/epidemiology , Snake Bites/therapy , Tetanus Toxoid/administration & dosage , Treatment OutcomeABSTRACT
Notable scientific developments have taken place in the field of anaphylaxis and urticaria in recent years; they are highlighted in this review. Case-control studies, genome-wide association studies, and large omics analyses have promoted further insights into not only the underlying genetics but also the biomarkers of both anaphylaxis and urticaria. New evidence regarding IgE-dependent and non-IgE-dependent mechanisms of anaphylaxis and urticaria, including the Mas-related G protein-coupled receptor (MRGPR [formerly MRG]) signaling pathway, has been gained. Putative elicitors of anaphylactic reactions in the context of coronavirus disease 2019 (COVID-19) vaccination and impact of the COVID-19 pandemic on the management and course of chronic urticaria have been reported. Clinical progress has also been made regarding the severity grading and risk factors of anaphylaxis, as well as the distinction of phenotypes and elicitors of both diseases. Furthermore, novel treatment approaches for anaphylaxis and subtypes of urticaria have been assessed, with different outcome and potential for a better disease control or prevention.
Subject(s)
Anaphylaxis , COVID-19 , Humans , Anaphylaxis/etiology , Anaphylaxis/therapy , Pandemics , Genome-Wide Association StudyABSTRACT
PURPOSE OF REVIEW: The COVID-19 vaccines have proved essential in our defense against the COVID-19 pandemic. However, concerns regarding allergic reactions to the vaccines persist to this day. Herein, we review the data regarding the frequency of allergic reactions to the COVID-19 vaccines, the epidemiology, and the management of patients reporting vaccine allergic reactions. RECENT FINDINGS: Although initial reports emphasized a high risk of anaphylaxis to the COVID-19 vaccines, more recent data demonstrate similar rates of anaphylaxis to the COVID-19 vaccines as to other vaccines. Alternative explanations for increased rates of apparent allergic reactions are discussed, including the role for stress-related and nocebo responses. COVID-19 vaccines and mRNA vaccine technology are overwhelmingly safe and well-tolerated by most patients. Careful history and case review will enable the discerning physician to safely vaccinate most patients. Rare patients with objective signs and symptoms of anaphylaxis may be candidates for alternatives to vaccination including monoclonal antibodies.
Subject(s)
Anaphylaxis , COVID-19 , Humans , COVID-19 Vaccines , Pandemics , Risk Factors , RNA, MessengerABSTRACT
COVID-19 is an infectious disease caused by a single-stranded RNA (ssRNA) virus, known as SARS-CoV-2. The disease, since its first outbreak in Wuhan, China, in December 2019, has led to a global pandemic. The pharmaceutical industry has developed several vaccines, of different vector technologies, against the virus. Of note, among these vaccines, seven have been fully approved by WHO. However, despite the benefits of COVID-19 vaccination, some rare adverse effects have been reported and have been associated with the use of the vaccines developed against SARS-CoV-2, especially those based on mRNA and non-replicating viral vector technology. Rare adverse events reported include allergic and anaphylactic reactions, thrombosis and thrombocytopenia, myocarditis, Bell's palsy, transient myelitis, Guillen-Barre syndrome, recurrences of herpes-zoster, autoimmunity flares, epilepsy, and tachycardia. In this review, we discuss the potential molecular mechanisms leading to these rare adverse events of interest and we also attempt an association with the various vaccine components and platforms. A better understanding of the underlying mechanisms, according to which the vaccines cause side effects, in conjunction with the identification of the vaccine components and/or platforms that are responsible for these reactions, in terms of pharmacovigilance, could probably enable the improvement of future vaccines against COVID-19 and/or even other pathological conditions.