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[This corrects the article DOI: 10.3389/falgy.2022.818049.].
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Case report: Chronic urticaria is defined as the presence of urticaria for a period exceeding six weeks. Infections are known as possible triggers for urticaria manifestations, and, as such, SARS-CoV- 2 infection can be recognized as causative. An 8-year- old boy, with a previous history of idiopathic chronic urticaria, came to the Emergency Department for the appearance of generalized urticaria and lips angioedema associated with vomit and shortening of breath normal vital signs by age. Thus, due to the significant reaction, intravenous corticosteroids and antihistamines were promptly administered, with a rapid improvement of symptoms. Since the systemic reaction, the tryptase dosage was performed with the identification of an elevation at the time of the arrival and a complete normalization after the twelfth hour from the beginning of the reaction. Figure 1 shows the kinetic of the tryptase over time. SARS-CoV2 swab was performed before hospitalization and a positive test was identified. To investigate the etiopathogenesis of reaction, the patient was submitted to the extensive clinical, laboratory, and instrumental investigations that revealed only a positive in vitro basophil activation test (BAT) as evidence of functional serum histamine-releasing autoantibodies that are directed against IgE or high-affinity IgE receptors. The viral infection did not need any medication, and the urticaria was resolute in a couple of days. Daily treatment with oral antihistamines was then prescribed, and no further urticarious episodes occurred. A negative SARS-CoV- 2 swab was detected within 12 days of beginning symptoms. Approximately 40% of patients with idiopathic chronic urticaria have circulating antibodies versus IgE epitopes or the IgE receptor, but as it occurs in many autoimmune conditions, the presence of autoantibodies does not necessarily result in a disease phenotype. It is demonstrated that infections can elicit an autoimmune condition, and as our report shows, SARS-CoV2 could explain the reaction observed in our patient. The autoimmune precondition could have been the primer of the systemic reaction, pre-activating the mastocyte degranulation, as the tryptase elevation demonstrated. On the other hand, the SARS-CoV2 virus reducing the ACE2 expression, due to virus endocytosis, could create an imbalance in the RAS system, increasing the bradykinin levels. Bystander activation of pre-activated mastocytes caused by an inflammatory environment could explain the systemic reaction described above.
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Background: Drug hypersensitivity reactions (DHRs) of the immediate type are diagnosed in approximately 1-2% per 100 thousand people. During the COVID-19 pandemic, the use of antibiotics increased, and cases of immediate reactions to these drugs became more frequent. However, due to the lack of medical centers which have the necessary conditions for carrying out provocation tests, the use of in vitro diagnostic methods for hypersensitivity reactions to antibiotics is becoming even more relevant during the pandemic. Flow CAST Basophil Activation Test (BAT) Flow Cytometry can be used for the in vitro detection of immediate type allergic reactions and hypersensitivities to suspected allergens in patients at risk for DHRs. The purpose is to study the possibility of diagnosing hypersensitivity reactions to antibiotics using BAT to antibiotics. Method(s): The Patient Questionnaire Card and the Patient Review Card were used to survey 32 (8.7%) individuals (f -56.3%, m -43.7%) who met the inclusion criteria (the presence of hypersensitivity reactions to beta-lactam antibiotics during the last 3 years). We used Flow CAST to identify the DHRs to beta-lactam antibiotics (Ceftriaxone (conc. 4 mg/ml);Cefuroxime (conc. 2.5 mg/ml);Amoxicillinum (conc. 2.5 mg/ml) from CAST Allergens for CASTFlow CAST) BUHLMANN LABORATORIES AG, Switzerland) in whole blood. Flow cytometric acquisition was performed on a flow cytometer BD FacsCalibur (USA), and 300 basophilic cells were analyzed. Result(s): The most common clinical manifestations included acute urticaria + angioedema (40.6%), generalized urticaria (28.1%), anaphylactic shock (21.9%), bronchospasm (9.4%). The percentage of patients diagnosed with an immediate reaction based on the time of its occurrence was 62.5%, whereas the percentage of patients diagnosed with an immediate reaction based on the clinical manifestations was 81.25%, which was confirmed by positive BAT results (p > 0.05). 68.75% of people with clinical manifestations of reactions to one antibiotic (ceftriaxone or amoxicillin) showed increased values on the BAT test to other beta antibiotics, which may indicate the presence of cross-reactivity between these groups of drugs. Conclusion(s): Diagnostics of immediate hypersensitivity reactions to antibiotics based on in vitro BAT is a highly accurate method. However, in cases of possible cross-reactivity between antibiotics and in cases of delayed reactions, in-depth studies are required.
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Background: Use of ultrasound contrast agent spread increasingly in worldwide. Although few side effects are published, number of increase anaphylactic reaction is reported. A recent cautionary remark was published about polyethylene glycol (PEG) as culprit for some ultrasound contrast agent hypersensitivity (Krantz et al. JACIP. Avril 2020). A 22 years-old woman was referred for a severe anaphylaxis after a second injection of Sulphur Hexafluoride (SonoVue, Bracco, Milan, Italy). The investigation was performed to explore hepatic multinods. She already had presented with uncomfortable feeling, generalized pruritus and nausea few minutes after the first injection of Sonovue, 10 months earlier. Three months before, she has recieved also a first injection of SPIKEVAX without any reaction. As Sonovue and SPIKEVAX contain PEG, we looked for a hypersensitivity to PEG and RNAm COVID-19 vaccine. Method(s): Skin tests and basophil activation test (BAT) with expression of CD63 were performed for SonoVue, PEG 3350 and 4000 and COMIRNATY. Result(s): Skin tests were negative for all products except the undiluted IDT to COMIRNATY. BAT to PEG and SonoVue were negative but positive to COMIRNATY. Despite a fractioned administration of COMIRNATY, the patient presented with an acute urticaria few minutes after the last injection Conclusion(s): The relationship between PEG, RNAm vaccine, and hypersensitivity to SonoVue is once again highlighted by this new report. (Soni et al. J Am Soc Echocardiogr, Oct 2021).
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Background: The newly developed mRNA-based COVID-19 vaccines can provoke anaphylaxis, possibly induced by polyethylene glycol (PEG) contained in the vaccine. The management of persons with a history of PEG allergy or with a suspected allergic reaction after the first dose remains to be defined. Methods: In this real-life study, we defined two cohorts of individuals: one pre-vaccination including 187 individuals with high-risk profiles for developing anaphylaxis and a second post-vaccination including 87 individuals with suspected allergic reactions after the COVID-19 mRNA vaccine. Upon negative skin test with an mRNA vaccine, a two-step (10-90%) vaccination protocol was performed. Positive skin tests were confirmed with the basophil activation test (BAT). Results: Among 604,267 doses of vaccine, 87 suspected allergic reactions (5 after the booster) were reported to our division for further investigations: 18/87 (21%) were consistent with anaphylaxis, 78/87 (90%) were female, and 47/87 (54%) received the BNT162b2 mRNA vaccine. Vaccine skin tests were negative in 96% and 76% of the pre- and post-vaccination cohorts, respectively. A two-step vaccination was tolerated in 232/236 (98%) of individuals with negative tests. Four individuals experienced isolated asthmatic reactions during the two-step challenge. Vaccine-positive skin tests were consistently confirmed by BAT; CD63 and CD203c expression was selectively inhibited with ibrutinib, suggesting an IgE-dependent mechanism. Conclusion: Sensitization to SARS-CoV-2 mRNA vaccines can be detected with intradermal testing. Significantly more individuals were sensitized to mRNA vaccines in the post-vaccination cohort. A two-step 10-90%-vaccination protocol can be safely administered upon negative skin testing.
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Novel messenger RNA (mRNA) vaccines have proven to be effective tools against coronavirus disease 2019, and they have changed the course of the pandemic. However, early reports of mRNA vaccine-induced anaphylaxis resulted in public alarm, contributing toward vaccine hesitancy. Although initial reports were concerning for an unusually high rate of anaphylaxis to the mRNA vaccines, the true incidence is likely comparable with other vaccines. These reactions occurred predominantly in young to middle-aged females, and many had a history of allergies. Although initially thought to be triggered by polyethylene glycol (PEG), lack of reproducibility of these reactions with subsequent dosing and absent PEG sensitization point away from an IgE-mediated PEG allergy in most. PEG skin testing has poor posttest probability and should be reserved for evaluating non-vaccine-related PEG allergy without influencing decisions for subsequent mRNA vaccination. Immunization stress-related response can closely mimic vaccine-induced anaphylaxis and warrants consideration as a potential etiology. Current evidence suggests that many individuals who developed anaphylaxis to the first dose of an mRNA vaccine can likely receive a subsequent dose after careful evaluation. The need to understand these reactions mechanistically remains critical because the mRNA platform is rapidly finding its way into other vaccinations and therapeutics.
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Background: The COVID-19 vaccines from Moderna and Pfizer represent 62% and 37% of the doses administered in Switzerland, respectively. By 28 June 2022, 1,228 reports of urticaria were submitted to Swissmedic, mainly after the first booster ( = 3rd dose) after primary vaccination. Aims: To define the patient's characteristics, timing, and mechanisms driving the onset of chronic spontaneous urticaria (CSU) after mRNA vaccines. Methods: Based on a collaborative effort with local practitioners, we identified 88 patients suffering from CSU. An online survey was submitted for further characterization of CSU. Basophil activation tests (BAT) with the mRNA vaccines were performed in 27 patients. Results: Seventy-one patients (80%) completed the survey. 75% were women. The median age was 41 (IQR:35-48). In 92% of the cases, urticaria started after the 3rd dose. Median days between vaccination and onset of CSU were 10 (IQR: 8-12). In 93% of the cases, patients received the Moderna vaccine. At the time of the survey, CSU was active in 86% of the cases representing a median duration of 115 days (IQR: 101-140). Inductile urticaria was reported in 38 patients (54%), mainly as symptomatic dermographism. BAT were not interpretable in 26% (n = 7), yet in 50% (n = 10) of the cases, they were positive for the mRNA vaccines. Conclusion: CSU was mainly reported after the booster dose of Moderna in adults at their 40s. It was associated with a high rate of sensitization against mRNA vaccines. Urgent studies are needed to establish whether a definitive link exists between CSU and booster doses with mRNA vaccines.
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Background: The management and mechanisms involved in allergies to mRNA anti-SARS Cov2 vaccines remain debated. The availability of mRNA vaccines limits their use for Basophil Activation Test (BAT). Cryopreservation of mRNA vaccines from leftover doses or vials may help standardize this assay better. Methods: Individuals with respectively negative (n = 10) and positive (n = 10) skin testing for mRNA vaccines were included in this study. CD63 upregulation in basophils was compared using fresh leftover or cryopreserved mRNA vaccines from Pfizer BioNTech (BNT162b2) and Moderna (mRNA-1273). Spike protein expression was used as a surrogate marker for the evaluation of mRNA vaccine's function in vitro. Results: CD63 upregulation in basophils was significantly higher in patients with positive intradermal skin testing (IDR) with both mRNA vaccines. A significant correlation was found comparing (1) fresh BNT162b2 and mRNA-1273 vaccines, (2) cryopreserved and fresh BNT162b2 vaccines, (3) cryopreserved and fresh mRNA-1273 vaccines, and (4) cryopreserved BNT162b2 and mRNA-1273 vaccines. Importantly, CD63 upregulation in basophils was independent of the capacity of the mRNA vaccines to induce spike expression. Conclusions: BAT performed with mRNA vaccines can be used as IDR surrogates to identify COVID-19 mRNA vaccine-sensitized individuals. These mRNA vaccines can be safely cryopreserved for BAT assays independently of their in vitro function. The current findings will allow broader use of mRNA vaccines for diagnostic tests and research purposes.
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BACKGROUND: The development of vaccines against SARS-CoV2 has been a key public health response to the COVID-19 pandemic. However, since their introduction, there have been reports of anaphylactic reactions to vaccines in individuals with history of allergic reactions to other vaccines, excipients or to COVID vaccines. AIM: A dedicated adult COVID vaccine allergy clinic with a standardised allergy testing protocol was set up to investigate safety and suitability of available COVID vaccines in Australia. METHODS: Patients referred to a state-wide COVID-19 vaccine allergy clinic between March and August 2021 with a history of allergy underwent skin-prick testing and intradermal testing to both available vaccine formulations (BNT162b2 and ChAdOx1-S), excipients (polyethylene glycol and polysorbate 80), excipient-containing medications and controls. Basophil activation testing was conducted in few subjects with convincing history of immediate type reactions. RESULTS: Fifty-three patients underwent testing for possible excipient allergy (n = 19), previous non-COVID vaccine reaction (n = 13) or previous reaction to dose 1 of COVID-19 vaccine (n = 21). Patients were predominantly female (n = 43, 81%), aged 18-83 (median 54) years. Forty-four patients tested negative and 42 of these received at least their first dose of a COVID-19 vaccine. Nine patients tested positive to excipients or excipient-containing medication only (n = 3), or vaccines (n = 6). Five patients were positive to just BNT162b2, 3/5 have been vaccinated with ChAdOx1-S. One who was skin test positive to both vaccines, but negative BAT to ChAdOx1-S was successfully vaccinated with ChAdOx1-S. CONCLUSION: Even in a high-risk population, most patients can be vaccinated with available COVID-19 vaccines. This paper reports local experiences using a combined allergy testing protocol with skin testing and BAT during the pandemic.
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Anaphylaxis , COVID-19 Vaccines , COVID-19 , Adult , Female , Humans , Male , Anaphylaxis/etiology , BNT162 Vaccine , COVID-19/epidemiology , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , COVID-19 Vaccines/therapeutic use , Excipients/adverse effects , Pandemics , SARS-CoV-2 , South Australia , Vaccination/adverse effects , Adolescent , Young Adult , Middle Aged , Aged , Aged, 80 and over , ChAdOx1 nCoV-19ABSTRACT
The basophil activation test (BAT) is a flow cytometric assay that evaluates the percentage of activation or degranulation of peripheral blood basophils, after “in vitro” exposure to specific allergens. In sensitized patients, the stimulation of peripheral blood basophils with a specific allergen induces or up-regulates the expression of molecules, such as CD63 and CD203c, which represent, markers of degranulation and activation of basophils, respectively. The validity of the BAT requires a negative control (sterile saline) and a positive control (anti-IgE molecules). Several studies have demonstrated the role of the BAT in supporting the diagnosis of drug, food and hymenoptera venom allergy. The BAT has shown a low sensitivity but good specificity in diagnosing allergy to drugs such as NSAIDs, beta-lactam antibiotics, quinolones and muscle relaxants. In food allergy, the sensitivity and specificity of the BAT depends on the food;in the case of peanut allergy the sensitivity reaches 96% while the specificity the 100%. In addition, the BAT is an useful tool to monitor the natural resolution of allergies and the clinical effects induced by either immunotherapy or anti-IgE treatment. Finally, the BAT has been utilized to study the pathogenetic mechanisms underlying several IgE-mediated diseases. For example, in patients affected by severe bronchial asthma, the BAT has demonstrated the ability of Staphylococcus aureus enterotoxins to induce the activation of basophils supporting the role of these enterotoxins as “triggers” of the inflammatory cascade in bronchial asthma. In patients with cystic fibrosis the BAT can be used to dis-criminate allergic bronchopulmonary aspergillosis from Aspergillus colonization. More recently, the BAT has been demonstrated as a potential diagnostic tool to evaluate allergy to the polyethylene glycol (PEG) present in the anti-SARS-CoV-2 BNT162b2 mRNA vaccine.
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BACKGROUND: One of the main barriers to vaccination against SARS-CoV-2 is the fear of developing hypersensitivity reactions to any of its components. Although these reactions are very rare, it is necessary to establish an effective protocol to detect patients at risk of developing them. The aim of this study was to evaluate hypersensitivity reactions in vaccinated patients in order to allow or not to complete the vaccination protocol. METHODS: Descriptive and cross-sectional study in which patients with suspected hypersensitivity to SARS-CoV-2 vaccines were evaluated. All patients underwent skin prick test (SPT) and/or intradermal test (IDT) with the vaccines and their excipients. In patients with positive IDT with the vaccine, a histopathological and immunohistochemical study was performed by skin biopsy. A basophil activation test (BAT) and a lymphoblastic transformation test (LTT) were also performed. RESULTS: Sixteen patients with suspected hypersensitivity to SARS-CoV-2 vaccine (12 received Comirnaty®, 3 received Vaxzevria®, and 1 received Spikevax®) were evaluated. Half had immediate hypersensitivity reactions and half had delayed reactions. All SPTs to excipients and vaccines were negative. IDTs with all excipients were negative. IDTs with vaccines were positive in 11 patients and negative in 5. The histological and immunohistochemical study of the two selected patients with positive IDT with vaccine showed T-lymphocyte involvement. BAT and LTT were negative in both cases. The vaccination protocol could be completed in 7 of 16 patients (44%) studied. The remaining 9 patients did not receive the second dose: 5 because vaccination was not required and 4 because they refused to be vaccinated. CONCLUSIONS: Thanks to the allergological and immunohistochemical study, the vaccination protocol could be completed in about half of the patients who presented suspected hypersensitivity reactions to SARS-CoV-2 vaccines. IDTs with vaccines could be a valuable method for assessing the immunogenicity of the vaccines.
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The worldwide use of COVID-19 vaccines has shown that immediate allergic reactions to the ingredients are rare but should be clarified by means of an allergological work-up. This review aims to highlight the current state of knowledge and possible pathogenesis based on the literature published to date. In addition to recording a detailed history and performing skin tests, cellular tests (basophil activation or basophil histamine release test) by using the vaccines or modified compounds containing polyethylene glycol (PEG), rather than unmodified PEGs, have proven to be particularly helpful. Negative results with vaccines seem to indicate tolerance. Details of the performance of these cellular tests with different vaccines, PEGs of different molecular weights, other ingredients of the vaccines, as well as other PEGylated drugs, and the results in the context of COVID-19 vaccination of various working groups worldwide are summarized.
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COVID-19 Vaccines , COVID-19 , Hypersensitivity , Basophil Degranulation Test , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , Humans , Polyethylene GlycolsABSTRACT
Background: The newly developed mRNA-based COVID-19 vaccines can provoke anaphylaxis. Management of persons with an immediate reaction suggestive of an allergy after the first dose remains to be defined. The newly developed mRNA-based COVID-19 vaccines can provoke anaphylaxis. Management of persons with an immediate reaction suggestive of an allergy after the first dose remains to be defined. Method: Skin testing was performed with both mRNA-based vaccines. Upon a negative skin test, a 2-step (10 + 90%) revaccination protocol was performed. Positive skin tests were confirmed with a Basophil Activation Test (BAT). Results: 25'162 first doses of COVID-19 vaccines (80% from Pfizer BioNTech) were administered at the university hospital of Lausanne. Respectively, 3.47 and 1.99 immediate reactions per 10'000 doses were observed with the vaccine of Pfizer BioNTech and Moderna. An allergy workup was performed in 18 persons among who 11 were referred from external centers. 17/18 (94%) were females and 7/18 (39%) had criteria for anaphylaxis. 3/18 (17%), 2/3 with anaphylaxis, had positive intradermal reactivity after 20 minutes for both mRNA vaccines. BAT was positive in 2 persons and is pending in the third one. 14 patients had negative skin testing. Among those 8 received a 2-step re-vaccination protocol, 3 refused revaccination, and 3 wait for revaccination. 8/8 with negative tests tolerated the 2-step re-vaccination. One patient with suspicious skin tests but positive BAT developed again urticaria 7 minutes after the 90% dose. Conclusion: Only 22% of patients, all females, with an immediate reaction to the first vaccination were sensitized to the vaccine. A two-step re-vaccination protocol could be safely administered upon negative skin testing.
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Background: With the launch of COVID-19 vaccination, cases of allergic reactions to tozinameran were soon reported, with excipient polyethylene glycol (PEG) 2000 becoming the principal suspect. We present the immediate reactions recorded in our Vaccination Center, the allergological workup performed and the outcome of the second dose whenever administered. Method: This is a prospective study among people working in public health care facilities and armed and security forces who received the first dose between 27/12/2020 and 17/01/2021. Reactions with at least one objective sign observed within 6 hours after vaccination were recorded. Allergological investigation was carried out 14-20 days later as follows: 1/ skin prick tests to tozinameran 100%, PEG 6000 (100mg/ml) 10% and 100%, polysorbate 80 (50mg/ml) 10% and 100%, intradermal tests with PEG 6000 up to 1% and polysorbate 80 up to 0.1% both in three consecutive 10-fold dilutions, 2/ serum tryptase (reaction's and basal), 3/ basophil activation test (BAT) to PEG 2000. The same work-up was followed for patients who had received their shot in other vaccination centers but were referred for investigation. Results: From a total of 1755 immunizations, 14 reactions (0.8%) were recorded in our unit and extra 8 referred reactions were included in the work-up. Median age was 43.5 years (range 28-59) and 72.7% were female. Mean time of onset was 14 min (range 3-40) with a broad duration frame (1-72h). Hypertension and tachycardia were the most prevalent symptoms (86.4% and 77.3% respectively);flushing (63.6%), nausea/eructation or intestinal hyperperistalsis (36.4%), tremor (22.7%) were also recorded. Reaction's serum tryptase was measured in 8/20 patients;elevated compared to baseline was detected only in a 32ys old female treated with IM adrenaline. Skin tests were performed in 17/22 patients, none turned positive. BAT results were positive in 1/5 reactors. Finally, 13/22 already received the second dose, with 10/13 (77%) not reacting at all, while the rest experienced a much milder similar reaction. Conclusion: Female predominated and a special pattern of reaction with elevated blood pressure/ heart rate along with flushing and/ or increase in gastrointestinal motility, resembling the acute stress response (“fight-or-flight”) was observed. PEG does not seem to be the offending “allergic” agent. Polysorbate 80 can be tested before administration of other SARS-CoV-2 vaccine in case of suspended PEG allergy. (Table Presented).
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Background: To describe anaphylactic/anaphylactoid reactions induced by mRNA-vaccines against SARS-CoV-2 and immune-allergic studies carried out. Method: Twenty two patients were referred prior to the administration of the second dose of vaccine. Skin tests were performed to both mRNA vaccines (Pfizer and Moderna1/1), different sources of poliethylenglycol (PEG), Polysorbate 80 and Trometamol. Total IgE, specific IgE to ethylene oxide, tryptase and Basophile activation test (BAT) were performed to the same reactives including both Pfizer and Moderna vaccines adding PEG2000. Results: Four anaphylaxis/anaphylactoid reactions are documented. One of them with the entire study negative. The remaining three cases were non-severe anaphylaxis. PEG 1.500 0,1%, 1% and 10%, Polysorbate 80 (0,04mg/ml) and Trometamol (1 mg/ml) were negative in all cases. TAB was positive only to Pfizer and Moderna vaccines but not to PEG or other excipients. Four additional woman with positive skin test were observed in the same period of time related to the first exposition to vaccines and only positive test were obtained with vaccines but not to PEG or other excipients studied. All of them sanitary workers affected by urticaria and/or angioedema and adenitis associated with cutaneous delayed reaction. More than 20 skin tests were negative as the same concentrations in other patients with suspected adverse reactions to vaccines or other drugs containing PEG. All negative patients were encouraged to receive the second dose and 10 did not have a recurrence of reaction. More than 10 BAT were also performed in cases and controls with negative results to PEG. A positive specific IgE to ethylene oxide was obtained. Conclusion: Different mechanisms of anaphylactic/anaphylactoid reaction are inferred from the results. In the most severe case, it was not possible to demonstrate an IgE mechanism involved. Skin test to vaccines involved were the most useful tool to diagnose hypersensitivity reactions. PEG was positive in one case, Ethylene oxide was positive in other case (associated with positive ID test to vaccines) and BAT in other two patients.
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BACKGROUND: mRNA-based COVID-19 vaccines have been reported to induce hypersensitivity reactions (HSR) in a small number of individuals. We aimed to evaluate the real-world incidence of the BNT162b2 mRNA COVID-19 vaccine HSR and to determine the value of the basophil activation test (BAT) in the allergological workup of patients reporting these reactions. METHODS: We prospectively enrolled patients with a clinical history indicative of HSR to the BNT162b2 mRNA COVID-19 vaccine. The allergological workup included skin testing (STs) and BAT with polyethylene glycol (PEG) and the vaccine. In those with negative allergy assessments, the administration of the second dose of the BNT162b2 mRNA COVID-19 vaccine was offered. RESULTS: Seventeen adults were included. Eleven cases (64.7%) tested negative in the allergological workup and tolerated the re-administration of the second dose of the vaccine and considered non-allergic. Six cases (35.3%) were considered allergic and classified into three groups: 2 subjects displayed positive STs and/or BAT to PEG (Group A), two individuals displayed positive BAT to the vaccine (Group B), and in 2 patients with moderate or severe reactions, the culprit was not identified, tested negative to STs and BAT to both PEG and vaccine (Group C). We further evaluated the value of BAT when the results were positive to the vaccine and negative to PEG by performing BAT in controls groups, finding positive BAT results in 50% of controls, all of them recovered from COVID-19 infection. In contrast, BAT was negative in patients who had not suffered from COVID-19 disease. CONCLUSIONS: BAT can be used as a potential diagnostic tool for confirming allergy to PEG excipient but not to the vaccine as a positive result in BAT may indicate a past COVID-19 infection instead of an allergy.
Subject(s)
COVID-19 Vaccines/adverse effects , COVID-19 , Drug Hypersensitivity , Adult , BNT162 Vaccine , Basophil Degranulation Test/methods , Basophils , COVID-19/diagnosis , COVID-19/prevention & control , Drug Hypersensitivity/diagnosis , Humans , RNA, MessengerABSTRACT
The main contraindication to the anti-SARS CoV2 vaccine is an anaphylactic reaction to a vaccine component. The need to vaccinate allergic people who are at higher risk can be of public health interest and this report shows a case of an allergic reaction to PEG of a HCW who had received the first dose of anti-SARS CoV2 vaccine. For 5 h after the administration of the vaccine, she had the appearance of erythematous spots on the face and neck, and a feeling of a slurred mouth and hoarseness. In order to treat the event, she was administered 8 mg intravenous dexamethasone, 1 vial intravenous chlorphenamine maleate, 250 mL intravenous 0.9% NaCl, and conventional oxygen therapy (2 L/min) with complete resolution of the suspected adverse drug reaction. According to the contraindication to the cutaneous test for this patient, BAT was used for further investigations. The patient who suffered the adverse reaction to the COVID-19 vaccine and other five allergic patients who did not report any adverse reaction after the vaccination were tested. There was a significant activation of the vaccine-reactive patient's basophils with 14.79 CD203chigh% at the concentration of 0.2 mg/mL, while other patients were negative. People who have a confirmed reaction to a vaccine component should undergo further investigation to discover other possible cross-reactions and select the right vaccine to immunize them.