Case Of Anaphylaxis Research Articles

Anaphylaxie alimentaire aux produits de la ruche : à propos de 32 cas déclarés au Réseau d’Allergo-Vigilance®

Food supplements based on products of the hive are very popular and considered beneficial to health. However, they are not without risk for atopic patients as pointed out by the notice issued by the ANSES in 2018.We present a retrospective descriptive study of cases of food anaphylaxis to bee-gathered pollen and hive products reported to the French Allergy-Vigilance® Network from 2002 to June 2021. ResultsIn all, 32 anaphylaxis cases were reported, i.e., 1.26% of all food anaphylaxis reports, 16 to bee-gathered pollen (50%), 14 to honey (40.6%), 2 to royal jelly (6.3%) and 1 to propolis (3.1%). Most of the patients were adults (81.3%), half of them suffering from grade 2 anaphylactic reactions and one third of them from grade 3. The 2 anaphylaxis to royal jelly were grade 3 with asthma. Among these patients, 37.5% were hospitalized, only 21.9% received adrenaline. Pollen sensitization was present in 87.5% of cases with seasonal rhinitis in 53.2%. In bee-gathered pollen anaphylaxis, all patients (100%) were sensitized to pollens with 75% for composites. Concerning honey anaphylaxis, 3 patients were not sensitized to pollens. ConclusionsThis is the largest reported series of anaphylaxis to bee-gathered pollen and hive products. Food allergy to pollen is most often linked to the presence of composite pollen (entomophilic pollens but also to anemophilic pollens), with the possibility of a link with bee secretion proteins such as MRJP1, which is the allergen incriminated in anaphylaxis to royal jelly.

L’anaphylaxie alimentaire chez le sénior : analyse des données du RAV de 2002 à 2020

Between 2002 and 2020, 172 food anaphylaxis cases in senior citizens were reported to the RAV. Sex ratio M/F was 0.85 and the average age was 67.3 years (60–93). The most frequent allergens are of plant origin: first, legumes (20 cases), then cereals (16 cases) and nuts (15 cases), mainly hazelnut. PR-10 proteins are involved in at least 11.7% of anaphylaxis cases. Like soy, anaphylaxis attributed to Cor a 1 is mainly reported by allergists practicing in Belgium and northeastern France. Anaphylaxis related to red meat and offal is the most frequent (24 cases, 13.9%), always associated with an alphaGal syndrome when anti-alphaGal IgE was tested. Sixteen are attributed to crustaceans, 8 to mollusks and fish respectively and 6 to Anisakis. This series confirms the rarity of cow's milk and egg allergy in the elderly. The RAV collected 4 grade I, 77 grade II, 84 grade III and 5 grade IV anaphylaxis cases including one death. Severity was significantly related to a history of heart disease or hypertension. Forty percent of the subjects had already presented an allergy in the past with the suspected food and only 55% had an adrenaline pen and 33% an action plan. This large series underlines the interest of a detailed allergological assessment in the elderly. Their management should not only include an emergency care protocol with an adrenaline auto-injector, but also therapeutic and dietary education for patient, his family and entourage. It should be formalized by a personalized care project (PCP), as for schoolchildren, given the risk of recurrence, comorbidities and loss of autonomy for some.

Vingt ans d’allergènes alimentaires rares déclarés au Réseau d’Allergo-Vigilance®

During its 20 years of existence, the Allergy-Vigilance Network® has identified 86 rare food allergens, each with a prevalence of less than 0.1% of the 2535 cases of severe food anaphylaxis reported. If they are in fact unknown, and revealed in this publication, their declaration has been a fundamental element for health monitoring and for the progression of knowledge in food allergy. The role of sentinel of the reporting physicians, to whom we pay tribute here, and the voluntary work they provide to feed this knowledge are precious and must continue more than ever in the years to come.

Le Réseau d’Allergo-Vigilance® fête ses 20 ans

The purpose of this article is to recall the circumstances of the creation of the Allergo-Vigilance® network (RAV), its legal framework and its missions: keeping a register of severe anaphylaxis cases whatever the etiology (food, drugs, hymenoptera or others), participation in multicentric studies, continuing medical education, publications, health watch role (emerging allergens..), epidemiological tool..In addition, the methods of collecting and analyzing declarations, access to the computer site (https://www.allergyvigilance.org), the main work of the RAV, the links with the European network NORA are recalled as well as the various projects to come.

Measures for food allergy emergency in nurseries.

As food allergy potentially can induce life-threatening anaphylaxis, measures for food allergy are required at nurseries caring for food allergy children, but a large-scale factual investigation has not been carried out. We evaluated measures for food allergy emergency in nurseries. A questionnaire survey regarding emergency measures in all authorized nurseries (411 facilities including 20,586 children) was conducted in Kawasaki city, Japan. The recovery rate of the questionnaire was 46.5%, which include 14,343 children of 191 facilities in total. A total of 637 children (4.4%) in 157 facilities (82.2%) requires elimination diets that were suggested by physicians. Among them, 22 children had been suggested to undergo the use of epinephrine auto-injection kit for emergency. 161 facilities (84.3%) had set a specific manual for emergency of food allergy. Emergency cases over the past one year were 4 cases and there was no case that had been suggested to use epinephrine auto-injection kit. All were anaphylaxis and the causes of these included 2 accidental digestion of culprit foods and the causes of other 2 cases were unknown. A case who required no elimination diet showed first episode of anaphylaxis. All cases were recovered. High percentage of nurseries in Kawasaki city has cared for food allergy children. While many children with food allergy have been in nurseries, only several cases of anaphylaxis have been reported for a 1 year. Among 4 cases of anaphylaxis, no specific cause has been recognized in 2 cases and 1 case has been the first episode of anaphylaxis. While most of nurseries have set specific measures for emergency of food allergy, there is certain possibility that nursery staffs can encounter the first episode of anaphylaxis even if there is no food allergy child. For all nurseries, emergency measures for food allergy are vital.

Cold Urticaria and Anaphylaxis Due to Ice Cube Challenge Test

Cold urticaria (CU) is a subtype of physical urticaria characterized by the development of urticaria and angioedema after cold exposure. Symptoms typically ocur minutes after skin exposure to anything cold like air, liquid or an object. Ice cube challange test is commonly used method to confirm the diagnosis of CU. The major complication of CU is anaphylaxis. In all CU cases, even in testing, it is important that anaphylaxis should be kept in mind, and special precautions should be taken. We wanted to report as the first known case of anaphylaxis which is occured in during the ice cube challenge test in the published literature.

Anaphylactic Shock Due to Psyllium (<i>Plantago ovate</i> Seed) Allergy: A Case Report

The seeds of Plantago ovata, called psyllium or ispaghula, have been used in the preparation of bulk laxatives. Nowadays, it is also used as an ingredient in bakery and breakfast cereals to increase dietary fiber and to give baking products fluffiness and viscosity. Mostly, there are described cases of occupational allergy that handle Plantago ovata seeds in powder laxatives and some cases of anaphylaxis after eating products containing psyllium. This case report is about a geriatric assistant who had an anaphylactic shock after eating a multigrain gluten-free piece of bread containing psyllium, who presented a positive skin test with psyllium in the allergy study. We recommended to the patient to avoid the ingestion and the inhalation at work of Plantago ovata seeds and to carry self-injectable adrenaline. With this case, we would like to highlight the growing uses of psyllium, especially in bakery products, and that it can behave like a hidden allergen.

ANALYSIS OF DRUG-INDUCED ANAPHYLAXIS CASES USING THE JAPANESE ADVERSE DRUG EVENT REPORT DATABASE

The epidemiology of drug-induced anaphylaxis (AN) using the Japanese nationwide database has not been reported, even though drugs are a common trigger of AN. This study aimed to describe the epidemiological profile of drug-induced AN, including fatal cases, using the Japanese Adverse Drug Event Report database (JADER). We extracted data regarding drug-induced adverse events between April 2004 and February 2018 published in JADER by the Pharmaceuticals and Medical Devices Agency. We analyzed cases of anaphylaxis occurring between January 2005 and December 2017. The drug classification was based on the Japanese Standard Commodity Classification. There were 16916 cases of anaphylaxis reported during the study period. Among them, 418 fatalities were registered. The incidence of drug-induced AN and fatal cases was 1.03 cases/year per 100000 population and 0.03 cases/year, respectively. The most frequent causes of AN were diagnostic agents including X-ray contrast media (20.3%) and biological agents including human blood preparations (20.1%). In fatal cases, diagnostic agents (28.7%) and antibiotics (23.9%) were the most frequent causes. The frequency of drug-induced AN and fatalities in Japan remained unchanged over the 12-year period analyzed in this study. Diagnostic and biological agents were the most frequent causes of AN. Contrarily, fatalities were most frequently caused by diagnostic and antibiotic agents.

Omalizumab treatment for chronic spontaneous urticaria: data from Turkey.

AimThe aim of the study was to investigate data from patients suffering from chronic spontaneous urticaria refractory to conventional therapy, and to document outcomes of omalizumab use.Material and methodsWe conducted a single-centre retrospective study with 175 chronic spontaneous urticaria patients who were treated with 300 mg omalizumab subcutaneously every 4 weeks for at least 6 months. Efficacy, factors affecting outcome, and complications were examined.ResultsThe complete response rate was 70.9%. Minor complications were observed in 12% of our patients. Anaphylaxis occurred in 1 patient as a major complication. We did not notice any clinical or laboratory factors predicting response to omalizumab treatment.ConclusionsThe findings show that omalizumab is effective and safe for the treatment of chronic spontaneous urticaria with a dosing of 300 mg/month subcutaneously. However, due to 1 case of anaphylaxis in this small group, we must still remind practitioners to be alert for this possible complication.

Anaphylaxis is rare due to CoronaVac in a population of healthcare workers

CoronaVac, the first coronavirus disease 2019 vaccine administered in our country, was found safe in clinical trials. We aimed to reveal the rate and features of CoronaVac vaccine-associated allergic reactions among vaccinated healthcare workers (HCWs) in real-life. This study was planned as a questionnaire-based study. Participants who reported a postvaccination allergic reaction were interviewed on phone and their medical records were also checked for confirmation. A total of 2,488 HCWs took part in the study and 4,054 postvaccination complete questionnaire-responses were obtained. Twenty-one HCWs (female: male, 17:4) with a mean age of 40.95 ± 10.09 stated that they had an allergic reaction after a total of 23 vaccine injections. Accordingly, the reaction rate was 0.56% among all vaccine doses. The most common reactions were systemic skin reactions (2.7%) consisting of generalized pruritus, diffuse pruritic erythema, urticaria, and maculopapular rash. That was followed by local injection site reaction (0.12%). Anaphylaxis was reported in 4 cases (0.09%) with a mean onset time of 12 ± 6 minutes. One of them had a history of anaphylaxis with 2 drugs, another had venom and food allergy. Three of the subjects had level 2 diagnostic certainty according to the Brighton Collaboration criteria and one had level 3. All anaphylaxis cases were discharged within 24 hours and none of them required intensive care. Our study demonstrated that allergic reactions to CoronaVac were rare and mostly mild. Although anaphylaxis was also rare, the importance of early intervention with close follow-up was once again emphasized.

A Case of Exercise-Induced Anaphylaxis Managed with Lifestyle Guidance Following Diagnosis Based on Thermal Stimulus and Exercise Challenge Tests

A Case of Exercise-Induced Anaphylaxis Managed with Lifestyle Guidance Following Diagnosis Based on Thermal Stimulus and Exercise Challenge Tests

Janssen COVID-19 vaccine tolerated in 10 patients with confirmed polyethylene glycol allergy

Polyethylene glycols (PEGs) and the structurally related polysorbates (PEG sorbitans—PEG molecular weight, 880-1056 g/mol) are excipients commonly used in small-molecule pharmaceutical drugs, as well as in some vaccines and most mAbs. Although polysorbates are common excipients in many vaccines, there is only a single case of vaccine anaphylaxis attributed to polysorbate 80 in a recent literature review.1,2 Similarly, the literature contains only a few cases of convincing skin test–confirmed immediate hypersensitivity to polysorbate 80 in mAbs, disinfectant solutions, intraarticular depot-steroids such as methylprednisolone acetate and triamcinolone acetonide, dexamethasone-lidocaine preparations for intramuscular and intraarticular injection (in Europe and some other countries), and subcutaneously injected erythropoietin.

S122: SAFETY AND EFFICACY OF CRIZANLIZUMAB IN ADOLESCENTS WITH SICKLE CELL DISEASE (SCD): INITIAL DATA FROM THE PHASE II, MULTICENTER, OPEN-LABEL SOLACE-KIDS TRIAL

Background: Vaso-occlusive crises (VOCs) are the hallmark of SCD. P-selectin, a cell adhesion molecule, plays a key role in the multicellular interactions leading to VOCs. In the SUSTAIN trial, crizanlizumab 5 mg/kg, a first-in-class humanized monoclonal antibody that blocks P-selectin, significantly reduced the annualized rate of VOCs versus placebo and had a favorable safety profile in adults with SCD. Aims: To describe the initial safety and efficacy results for patients with SCD aged 12 to <18 years treated with crizanlizumab 5 mg/kg in the SOLACE-kids trial (ClinicalTrials.gov: NCT03474965; EudraCT: 2017-001747-12). Methods: SOLACE-kids is an ongoing Phase II study to establish and confirm appropriate dosing (Part A) and evaluate long-term safety and efficacy (Part B) of the confirmed dose of crizanlizumab, with or without hydroxyurea, in pediatric patients with SCD (any genotype) and ≥1 VOC leading to a healthcare visit within 12 months prior to screening. Patients (target enrollment N≥100) are stratified by age: Group 1 (12–<18 years), Group 2 (6–<12 years) and Group 3 (6 months–<6 years). Patients receive crizanlizumab on Day 1, Day 15, then every 4 weeks (up to 2 years). This analysis reports initial safety and efficacy results for Group 1 patients receiving crizanlizumab 5 mg/kg. Results: As of 28 August 2020, 50 patients have been enrolled in Group 1 (median [min–max] age 14.9 [12.0–17.9] years; 58% female; 88% HbSS genotype; 64% Black/African American; 84% receiving hydroxyurea). Median (range) duration of crizanlizumab exposure was 36.6 (6–98) weeks; 88% of patients received treatment for ≥26 weeks. The most common adverse events (AEs) regardless of causality with study treatment were headache (n=14 [28%]), vomiting (n=12 [24%]) and back pain (n=9 [18%]). Treatment-related AEs occurred in 12 (24%) patients. Grade ≥3 AEs occurred in 13 (26%) patients, most commonly anemia (n=3 [6%]) and back pain (n=2 [4%]). Grade ≥3 treatment-related AEs (back pain and pain in extremity) were reported in one (2%) patient. Eleven (22%) patients had serious AEs; none were deemed treatment related. No AEs led to treatment discontinuation except one patient who died of suspected meningitis (considered unrelated to treatment). The incidence of AEs of special interest (AESI) is shown in Table 1. No infusion-related reactions were serious, and all had resolved at data cut-off, except for one case of Grade 1 dizziness. There were no cases of anaphylaxis to crizanlizumab. No pain events were serious, and all had resolved or were resolving by data cut-off. The median (Q1–Q3) number of VOCs leading to a healthcare visit at baseline was 3.0 (1.0–5.0) versus 1.6 (0.0–3.7) while on treatment, a median absolute reduction from baseline of –1.0 (–3.0 to 0.5). At baseline, the median (Q1–Q3) rate of hospitalizations/emergency room visits was 4.0 (2.0–8.0) versus 1.5 (0.0–2.7) while on treatment, a median absolute reduction from baseline of –2.4 (–5.0 to 1.0). Eighteen (36%) patients did not experience a VOC leading to a healthcare visit during crizanlizumab treatment. Summary – Conclusion: In this initial analysis, crizanlizumab 5 mg/kg was safe and well tolerated in patients with SCD aged 12–<18 years, consistent with the established profile of crizanlizumab in adults. No new safety signals were identified. Crizanlizumab 5 mg/kg led to a clinically relevant reduction in VOCs in this patient population compared with baseline.

A newborn with anaphylaxis due to vancomycin

All drugs may cause hypersensitivity reactions. Anaphylaxis is a medical emergency that rarely occurs in newborns due to immature immunity. Early diagnosis and treatment are life-saving. Vancomycin, a glycopeptide antibiotic with bactericidal action against Gram-positive bacteria, is commonly used for neonatal nosocomial sepsis. We hereby present a premature infant (born at the 33rd week of gestation, birth weight: 1745 grams) who was started on vancomycin on postnatal day 7. He had severe circulatory failure and stridor during infusion on day 7 of vancomycin treatment and his tryptase level was elevated to 64.60 micrograms/L Conclusions. To the best of our knowledge, there is no neonatal case of anaphylaxis due to vancomycin in the literature. Neonatologists should keep in mind that an anaphylactic reaction with a fatal course may develop during vancomycin infusion.

Anaphylaxie alimentaire létale et prélétale : les données du Réseau d’Allergo-Vigilance® (2002–2020)

Hospital admissions for food-induced anaphylaxis are increasing in most countries but mortality remains stable. ObjectiveAnalyze retrospectively cases of letal/preletal food-induced anaphylaxis (grade 4 among Ring and Messmer classification) recorded by the Allergy-Vigilance® network (2002–2020) and assess factors associated with survival. ResultsForty-two patients (male sex : 57%) of 2475 food anaphylaxis (1.7%) were recorded as grade 4 [mean age: 22.2 y (CI: 19.3) ; age<18y: 60%] and 19 (45%) died. Twenty-one (50%) had a history of asthma, 33 (79%) of food allergy [21% (50%) with the same index food allergen] and 13 (31%) of previous anaphylaxis. The most frequent allergens were: peanut (33%), milks (19%), shrimp (7%), hazelnut and wheat (5%, respectively). Food allergen was uncertain in 10%. Clinical symptoms were bronchospasm in 26 (62%) of cases and laryngeal oedema in 6 (14%). A cofactor was identified in 16 (38%) cases, mostly physical exercise (21%) and alcohol (14%). Allergic reaction occurred at home (26%), at school or in a restaurant (10%, each).No factor associated with survival was identified. Children were more likely to have a history of asthma (64% versus 29%, P=0.01) and less cofactors (20% versus 65%, P=0.02) than adults. ConclusionsThese data highlight on the high frequency of preletal anaphylaxis cases that are underestimated in epidemiological studies and also on the importance of risk factors (asthma, milks-peanut allergy) and cofactors in adults. It is necessary to better phenotype patients with a high risk of severe anaphylaxis and select those who will benefit a personalized approach (immunotherapy, biologicals).

Anaphylaxie aux antalgiques, antipyrétiques et anti-inflammatoires non stéroïdiens : analyse des cas déclarés au Réseau d’Allergo-Vigilance de 2002 à 2020

Non-opioid analgesics, antipyretics and non-steroidal anti-inflammatory drugs are the second cause of drug hypersensitivity and a major cause of drug-induced anaphylaxis. In this retrospective study, we analyzed epidemiological, demographic and clinical characteristics of the cases of anaphylaxis induced by these drugs and collected by the French Allergy-Vigilance Network (RAV) from 2002 to 2020 and compared our results with those of Pharmacovigilance, French and international data. One hundred and fourteen cases were collected. This number is very low, as compared with the French Pharmacovigilance data (1498), due to a low number of allergists who reported these cases to the RAV. Although the documentation of cases was not homogeneous (patient's medical history, risk factors, allergological work-up), our results are nearly similar to those of the French and international data. They confirm that these drugs are the second cause of drug-induced anaphylaxis, often secondary to self-medication with paracetamol and ibuprofen. They also confirm that hypersensitivity to these drugs is more frequent in adults than in children, that a personal atopy is a risk factor for allergic hypersensitivity, and that anaphylactic reactions are undertreated (underuse of epinephrine). They also suggest that reactions due to allergic hypersensitivity are more frequent in children than in adults. Finally, our results confirm that the diagnostic value of skin tests, specific IgE determinations and basophil activation tests is low, and that diagnosis of HS to these drugs is mainly based on a suggestive clinical history and/or provocation tests.

Evaluation of Knowledge About Anaphylaxis in Dentistry and Medical Faculty Students; Need for More Training

Objective: Anaphylaxis is a serious reaction that needs rapid intervention. However, some healthcare professionals may have inadequate knowledge about anaphylaxis to manage this situation. The aim of this study was to evaluate the level of knowledge about anaphylaxis in dentistry students (DS) in comparison with medical school ones (MS). Materials and Methods: Students were recruited from the Dentistry (n=81) and Medical (n=144) Faculties of the University Hospital. The level of knowledge about anaphylaxis was evaluated by using a questionnaire with 26 items that was used previously. Results: The overall response rate was 89.9%. One tenth of the study group had ever encountered a case with anaphylaxis, but 2.8% of them stated that they had involved in the treatment by themselves. Almost all of the participants stated that allergy might be a life-threatening reaction. Additionally, 43.3% reported that they had epinephrine in their department. DS knew less than MS about the primary use of epinephrine after assessing the airway, breathing and circulation in the treatment of anaphylaxis, and even in suspicious cases (59.3% vs. 98.6%, and 42% vs. 94.4%, all p&lt;0.001). DS had significantly less knowledge about anaphylaxis treatment and epinephrine application than medical ones (all p &lt;0.001). Furthermore, the information of that “the minimum duration for re-administration of epinephrine as 10 minutes” was known by the half of MS, and one fourth of DS (p&lt;0.001). The appropriate follow-up duration of patients with anaphylaxis was unknown in half of DS, and one fifth of MS (p&lt;0.001). Even though MS had a higher rate of knowledge about the responsible and closest department dealing with anaphylaxis than dental students (p=0.02), DS were more aware of referring the patient with anaphylaxis to an allergy clinic (77.8% vs. 62.9%, p&lt;0.001). Almost all MS had heard about the epinephrine auto-injector, in contrast to one third of the DS (p&lt;0.001). Most of the participants, but mainly the MS knew that anaphylaxis could be diagnosed clinically. The case questions about diagnosis of anaphylaxis related to local anesthetic and beta-lactam antibiotic use were answered correctly in a higher rate in MS than DS (p=0.01 and p&lt;0.001), whereas the rate of correct diagnosis of anaphylaxis following a bee sting was similar between the groups. Conclusion: This study showed the gaps about the diagnosis and management of anaphylaxis not only in MS, but also in dentistry ones. It is possible to encounter a case of anaphylaxis for every student during clinical practice in the future. Thus, education about anaphylaxis should be included in the national dentistry core education programme and be improved in the medical school as well. Keywords: Anaphylaxis, epinephrine, student, medical, denta

A Case Report of Prolonged Anaphylaxis after COVID-19 Vaccine.

IntroductionAs the medical community and world have combatted the coronavirus disease 2019 (COVID-19) pandemic, a significant advance was the development of a vaccine against the virus that has already claimed over 4.5 million lives worldwide.1 Vaccines manufactured by Pfizer-BioNTech and Moderna were the first two COVID-19 vaccines given emergency use authorization by the United States Food and Drug Administration. Preliminary data demonstrated not only the vaccines’ efficacy rates of greater than 95% after a second dose, but also marked safety. Initial data showed only 21 cases of anaphylaxis of greater than 1.8 million doses administered. The majority of those patients had a history of anaphylaxis and presented within the first 15 minutes after administration of the vaccine.2Case ReportWe describe a patient who had an anaphylactic reaction to her second dose of the Pfizer BioNTech severe acute respiratory syndrome coronavirus 2 (SARS CoV-2) vaccine with no prior history of allergic reactions or anaphylaxis. This reaction required multiple doses of epinephrine and a four-day hospitalization. We review both the available reports of anaphylaxis to the SAR CoV-2 vaccine and information on other prolonged cases of anaphylaxis.ConclusionOur case report is unique in that the patient, despite no prior history of anaphylaxis, had a prolonged course requiring a four-day hospitalization. To our knowledge this is one of the first case reports of prolonged anaphylaxis after the second dose of Pfizer BioNTech COVID-19 vaccine in a patient with no history of prior anaphylaxis.3

Acute unsolicited adverse events following BNT162b2 vaccine in Saudi Arabia, a real-world data

BackgroundAcute adverse events and anaphylaxis were reported after the administration of coronavirus disease (COVID-19) mRNA vaccines. We aim to explore the nature and outcome of adverse events following BNT162B2 vaccine in a community vaccination center, Riyadh, Saudi Arabia. MethodWithin 30 min post vaccination, all acute adverse events (AAEs) that occurred before March 31st, 2021, and in people older than 16 years were reviewed (AAE group). We used the case definition of Brighton collaboration on vaccine safety to define anaphylaxis. Patients’ demographics, comorbidities, allergy history, and outcome at disposition were collected. Observation duration after vaccination was short (<15 min) or extended (<3 h). Statistical analysis was performed to study AAEs association with the study variables and outcomes. ResultsOut of 71,221 vaccine recipients, 144 (0.002%) had developed 345 AAEs, at a rate of 48.4 events per 10,000 dose administered. The majority of cases in AAE group were first dose recipients (93.8%) and previously healthy (59%), while the minority had a previous history of allergy (6.3%) or a laboratory-confirmed COVID-19 (4.2%). We found a significant association between female gender and the occurrence of any AAE (p-value = 0.002). Per every 10,000 doses administered, non-anaphylactic AAEs were dizziness (17.8), headache (9.7), nausea (7.1), or syncope (3.2). Only one in every ten AAEs was considered serious and resulted in an extended observation (4.8 per 10,000 doses), but only 1/144 required hospitalization for non-anaphylaxis reasons (0.1 per 10,000 doses). According to the Brighton collaboration definition of anaphylaxis, no single case of high certainty anaphylaxis was recorded. No death was documented in this cohort. ConclusionAcute adverse events due toBNT162b2 vaccinewere rare andmostlynon-seriouswith a tendency to occur more in women. Further prospectivestudieson largervaccine recipientsto evaluatethe incidenceof anaphylaxis in the Saudi population are warranted.

Single-Dose Oral Challenges to Validate Eliciting Doses in Children With Cow’s Milk Allergy

To validate the predicted ED05 for cow’s milk, which is the allergen dose that elicits an objective reaction in 5% of a population, of 0.5 mg of cow’s milk protein (0.015 mL of fresh cow’s milk).The study included 182 children between the ages of 6 months and 17 years recruited from 4 centers in the United Kingdom, Ireland, and Spain. Inclusion criteria varied across centers. Participants had to have cow’s milk allergy (CMA), defined by either a clinical history and immunoglobulin E (IgE) sensitization and/or positive food challenge result.The participants were given 0.5 mg of milk protein as either a single unblinded administration or the first dose of a double-blind placebo-controlled food challenge, depending on the center. The predetermined objective criteria for a positive oral food challenge were standardized among centers and included urticaria, angioedema, or rhinoconjunctivitis symptoms that persisted for at least 5 minutes or anaphylaxis. To ensure that all participants had confirmed CMA, clinical reactivity to cow’s milk was assessed in participants >1 year of age by food challenge and in those <1 year of age by history of an allergic reaction within 2 months of the study visit and the presence of IgE sensitization to cow’s milk. Blood samples and skin-prick testing were used to confirm the presence of IgE to cow’s milk in all participants. The proportion of participants reacting to 0.5 mg cow's milk protein was estimated with 2-sided exact 95% confidence intervals (CIs).Of the 182 children who met the inclusion criteria, 10 were excluded because they did not have clinical reactivity when undergoing the confirmatory milk challenge. Of the remaining 172 participants with confirmed clinical reactivity to cow’s milk who underwent the ED05 0.5 mg cow’s milk protein oral food challenge, objective symptoms that met the predetermined positive challenge criteria were observed in 7% (95% CI: 3.7% to 11.9%). One participant (17 years old) experienced chest tightness, wheezing, a drop in peak expiratory-flow rate, and truncal erythema and was treated with epinephrine. All other reactions were mild and did not require treatment. No predictors of reactivity to 0.5 mg cow's milk protein were identified.In this study population, 7% of participants reacted to the proposed eliciting dose of 0.5 mg of cow’s milk protein, leading the authors to conclude that 0.5 mg could be a threshold amount of cow’s milk protein to inform food product allergy labeling for cow’s milk content.Although clear food labeling regarding allergen content and risk of allergic reaction is key to ensuring that those with CMA do not overly restrict their diets (while ensuring that they are protected from having a serious allergic reaction), establishing an ED05 to guide food labeling is challenging because of the striking heterogeneity in clinical reactivity among children with CMA. In this study, the authors highlight these challenges because 1 participant experienced an anaphylactic reaction, which translates to 0.5% of the study population. This observation suggests that if foods that contained ≤0.5 mg cow’s milk protein per serving were labeled as safe and children with CMA ate those foods on a regular basis, we might expect to see many cases of anaphylaxis. However, there is a substantial degree of uncertainty around the 0.5% estimate because the 95% CI ranges from 0.01% to 3.2%, highlighting the fact that much larger studies will be needed to have greater certainty about the expected incidence of anaphylaxis to this dose of cow’s milk protein. Additionally, in the study, the researchers found that as many as 12% of similar children would react to 0.5 mg, which, rather than validating an ED05 of 0.5 mg, suggests that the true ED05 may be <0.5 mg. These aforementioned challenges to identifying an ED05 are further complicated by the fact that there were no predictors of reactivity to the 0.5 mg dose. Nevertheless, more work is needed in this area because the current approach to food labeling is confusing and challenging for patients with CMA and their families to navigate.