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Background: During the initial rollout of COVID-19 vaccination in Singapore, the Ministry of Health (MOH) issued recommendations that patients with a history of any previous vaccine allergy be referred to an allergist for further review on suitability to proceed with mRNA-based COVID-19 vaccines. We review the evaluation of these patients with suspected vaccine allergies prior to receiving mRNA-based COVID-19 vaccines. Method(s): Between 8 April and 22 September 2021, 304 patients were evaluated prior to receiving the COVID-19 vaccinations. Of these, 63 (20.7%) patients with suspected immediate hypersensitivity reactions to non-COVID polysorbate-containing vaccines proceeded to have skin prick test (SPT) and Intradermal test (IDT) to polyethylene glycol (PEG)-3350, polysorbate 80 and polysorbate 20 containing products. Another 62 (20.4%) who reported delayed hypersensitivity reactions to polysorbate-containing vaccines proceeded to have direct inoculation (DI) of the Pfizer BNT162b2 vaccine under the supervision of an allergist. The remaining 242 (76.6%) finally assessed not allergic polysorbate-or tolerated previous non-polysorbate- containing vaccines were recommended to proceed with COVID-19 vaccinations at the community vaccination sites. 99 patients in the SPT/IDT and DI group completed a questionnaire-based survey to report any post vaccination reactions. (Figure 1) Results: Of 63 patients who underwent SPT/IDT, 2 (3.2%) with equivocal IDT tolerated both doses of the BNT162b2 vaccine without major allergic reactions. 61 (6.8%) patients with negative SPT/IDT and 62 (100%) in the DI group completed both doses of BNT162b2 vaccination without major reactions. Among those who completed the questionnaire survey, 13 (13%) reported reactions including non-specific rashes and mild urticaria/angioedema post first dose vaccine. All subsequently completed the second dose of the BNT162b2 vaccine following allergist review;with 8 (61.5%) reporting similar mild skin reactions. Conclusion(s): Majority of those with suspected reactions to polysorbate containing vaccines are able to tolerate the BNT162n2 vaccine which contains PEG-2000. Skin tests prior to mRNA COVID-19 vaccination is unnecessary. Those who report mild potentially allergic reactions after the first dose are able to tolerate the second dose of the BNT162b2 vaccine.
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SESSION TITLE: Autoimmune Diseases Gone Wild: Rare Cases of Pulmonary Manifestations SESSION TYPE: Rapid Fire Case Reports PRESENTED ON: 10/18/2022 01:35 pm - 02:35 pm INTRODUCTION: Post-Covid-19 Multisystem Inflammatory Syndrome (MIS) is a severe hyperinflammatory syndrome associated with either the acute or recovery phase of covid-19 infection affecting multiple organ systems requiring hospitalization. This syndrome has been described in both children (MIS-C) and adults (MIS-A). Several case reports and systematic reviews have reported an association between post-covid-19 MIS-A and several autoimmune diseases. CASE PRESENTATION: We herein report a case of a 27-year-old female with no known chronic medical condition and a non-contributory family history who was diagnosed with post-covid-19 multisystem inflammatory syndrome in adults (MIS-A). She presented with generalized partial thickness erythematous skin ulcerations with tender blistering and painful erosion of her mucus membranes (oral and vaginal mucosa). This was diagnosed as Steven Johnsons syndrome. She was pulsed with intravenous methylprednisone. During this therapy, she progressed to severe acute respiratory distress syndrome (ARDS) requiring mechanical ventilation (fig 1). Bronchoscopy revealed mild pulmonary hemorrhage fig 2a&b). Serological testing heralded a new onset systemic lupus erythematosus in light of positive antinuclear antibodies, anti Ds DNA and anti Smith antibodies. Her course was complicated by significant proteinuria and an active renal cast suggestive of lupus nephritis. This necessitated further treatment for active lupus. She was successfully extubated and discharged home. DISCUSSION: We arrived at the diagnosis of post-covid-19 multisystem inflammatory syndrome in adults (MIS-A) in light of her presenting with fever, hypotension, persistent sinus tachycardia and new onset atrial fibrillation), acute pancreatitis, acute kidney injury, elevation in transaminases, new onset skin rash, elevated inflammatory markers and a recent history of positive SARS-CoV-2 infection. Covid-19 has been reported to induce wide spread vasculitis resulting in MIS-A or MIS-C by triggering type 3 hypersensitivity (1). Also, multiple case reports and systemic reviews have reported a direct association between MIS-A and several autoimmune diseases including SLE, SJS (2). The patient recovered with high dose corticosteroid and supportive therapy indicating her severe ARDS was most likely due associated to SJS, SLE and MIS-A. Clinicians should also keep in mind that SARS-CoV-2 PCR swab may be negative at the time patient presents with symptoms of MIS-A as the infection might have occurred about 4-5weeks prior just as in our patient(3) CONCLUSIONS: We cannot underscore enough the importance of clinicians having a high index of suspicion for this syndrome in patients with acute or recent covid-19 infection, with or without a positive PCR covid-19 test. Early involvement of a multidisciplinary approach and appropriate management is essential to mitigate morbidity and mortality in these patients. Reference #1: Roncati L, Ligabue G, Fabbiani L, Malagoli C, Gallo G, Lusenti B, et al. Type 3 hypersensitivity in COVID-19 vasculitis. Clin Immunol Orlando Fla. 2020 Aug;217:108487. Reference #2: Gracia-Ramos AE, Martin-Nares E, Hernández-Molina G. New Onset of Autoimmune Diseases Following COVID-19 Diagnosis. Cells [Internet]. 2021 Dec 20 [cited 2022 Mar 22];10(12):3592. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8700122/ Reference #3: Morris SB. Case Series of Multisystem Inflammatory Syndrome in Adults Associated with SARS-CoV-2 Infection — United Kingdom and United States, March–August 2020. MMWR Morb Mortal Wkly Rep [Internet]. 2020 [cited 2022 Mar 22];69. Available from: https://www.cdc.gov/mmwr/volumes/69/wr/mm6940e1.htm DISCLOSURES: No relevant relationships by Isaac Ikwu No relevant relationships by Anthony Lyonga Ngonge No relevant relationships by Alem Mehari No relevant relationships by Noordeep Panesar no disclosure on file for Vis al Poddar;No relevant relationships by Emnet Yibeltal
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Background: The purpose of the study is to analyze the type of hypersensitivity reactions (HR) with Pfizer-BioNTech COVID-19 Vaccine (Comirnaty®) referred to our Allergy Department (AD), in order to asses vaccination with second dose safely. Method: Subjects with suspicion of HR after administration of first dose of Comirnaty® were referred to our AD from the Prevention and Occupational Risk Department responsible for the vaccination of hospital staff. Clinical history with special attention to atopic comorbidities and a detailed description of the HR after first dose of Comirnaty® was recorded. After providing signed informed consent, subjects underwent an allergy workup consisting of skin prick tests and intradermal tests (immediate and delayed readings) with polyethylene glycol (PEG) 4000 (1, 10 and 100 mg/ml), Polysorbate 80 (0.004 and 0.04 mg/dl), and Comirnaty® vaccine (as is). If skin tests proved negative, the second dose of Comirnaty® was administered under close supervision at our AD with an observation period of 60 minutes. Results: As of March 10, 2021, 6907 subjects had received the first dose of Comirnaty® and 5 were referred to our AD for evaluation. Mean age was 35 years, 4 were female and 1 male. Four patients had previous allergic history consisting of seasonal allergic rhinitis, contact dermatitis to nickel and thimerosal, and allergy to metamizole and mesalazine. After vaccination, two subjects had non-immediate reactions (NIR) that were generalized erythema within the first 48-96 h. Two subjects had immediate reactions (IR) 15 min after vaccination, consisting of generalized urticaria and erythema, and one was referred with a suspicion of immediate anaphylaxis but the reaction did not meet Brighton Anaphylaxis criteria. All subjects had negative skin tests with PEG-4000, Polysorbate 80 and Comirnaty®. The patient with the “suspicion of anaphylaxis” refused to receive the second dose. The remaining 4 subjects received the second dose of Comirnaty® with no reaction. Conclusion: The incidence of suggestive hypersensitivity reactions to Comirnaty® vaccine in our hospital staff was very low (0.07%). The administration of the second dose after a negative allergy workup seems safe, although the number of subjects treated is small.
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Background: The coronavirus disease 2019 (COVID-19) was first identified in December 2019 in Wuhan, China. The WHO declared the outbreak a Public Health Emergency of International Concern in January 2020 and a pandemic in March 2020. Until March 28 2021, more than 125 million cases have been confirmed, with more than 2.7 million deaths attributed to COVID-19. On December 21, 2020, the EMA issued an Emergency Use Authorization for Pfizer-BioNTech COVID-19 vaccine to prevent COVID-19, to be administered in 2 separate doses 21 days apart. The aim of this study was to identify and describe the suspected allergic reactions to first dose of Pfizer-BioNTech COVID-19 vaccine in health care professionals of our center. We also aimed to know if these reactions interfered with the compliance of vaccination protocol. Method: All health care professionals that receipt the vaccine were included. A prospective study was carried out using an online questionnaire to access the demographic data, personal allergic history and description of reaction to the vaccine. Results: In our hospital, the vaccination began on December 29, 2020. A total of 3040 first doses were administered. A total of 2095 (69%) questionnaire responses were collected. It was reported 1649 (79%) adverse events. Among these, 16 (1%) were identified as suggestive allergic reaction. These reactions occurred in professionals, 13 cases (81%) female, with a median age of 41 years (28-52y). The median interval from vaccine administration to symptom onset was 6 hours (5 min-48h). Eight professionals had late cutaneous reactions: 6 had mild reactions and tolerated the second dose;and 2 had severe reactions and it was decided not to administer the vaccine. The other 8 professionals had immediate reactions: 7 performed allergological study that was negative. The second dose vaccine was administered with vigilance and it was observed cutaneous reaction similar to prior reaction in only one case. Conclusion: In our study population, only 0.8% (16 of 2095) had a suggestive allergic reaction to first dose of the Pfizer-BioNTech COVID-19 vaccine. Half of them had immediate reactions and only 1 professional had a reproducible episode with the second dose;the other had late reactions and only 2 (0.1%) professionals did not complete the vaccination protocol. We can conclude that this vaccine has a good safety profile. and that mild reactions do not interfere with compliance with vaccination schedule.
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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: COVID-19 vaccines are being administered all over the world, but information is lacking about the frequency and type of allergic reactions associated to these new vaccines. Method: Retrospective study of health care professionals (HCP) from our hospital who received COVID 19 vaccine Comirnaty, between 29/12/2020 and 20/2/2021. We reviewed clinical data, particularly the immediate reactions after the administration (<6h), skin tests (ST) and graded vaccine administration. Following national guidelines, all HCP with previous history of food, drug or hymenoptera venom allergy or idiopathic anaphylaxis (IA) were first evaluated by an allergist. Vaccination was postponed if HCP had previous history of IA and/or recurrent anaphylaxis (RA), severe allergic reactions to vaccines and mast cell activation syndromes. ST to the vaccine (prick and intradermal) were performed in HCP with IA and/ or RA, severe allergic reactions to vaccines and HCP with immediate reactions to the 1st dose. Graded administration of the vaccine (0.1+0.2cc after 30') was performed in the postponed HCP and the ones with immediate reactions to the 1st dose. Results: From 3073 HCP who received the vaccine, 74.2% were female, mean age 40.2 years-old ± 13.4, 316 (10.3%) were evaluated by an allergist and 4 (1.3%) postponed the administration and performed allergy investigation. 2955 HCP (97%) were able to receive the 2 doses of the vaccine. 118 employees received only one dose: 98 had COVID-19 meanwhile, 7 got pregnant, 13 due to other conditions. Adverse reactions to the vaccine with possible hypersensitivity mechanisms, occurred in 17 (0.6%) HCP, 12 on the 1st dose and 5 on the 2nd dose. Observed reactions were 6 (0.2%) urticaria, 5 (0.16%) pruritus with or without flushing, 2 (0.07%) anaphylaxis (mild), 2 (0.07%) flushing and hoarseness, 1 (0.03%) flushing and nausea and 1 (0.03%) asthma exacerbation. ST with the vaccine were performed in 4 HCP, all negative in the immediate reading and 1 positive in non-immediate reading. 7 HCP undertook the graded administration with the vaccine: 6 tolerated, but one reproduced the immediate urticaria with 0.1cc of the vaccine (0.03% vaccine allergy). Conclusion: In the evaluated sample, suspicious allergic reactions to COVID19 vaccine Commirnaty were rare and allergy was only confirmed in one HCP. The allergist initial evaluation was essential for a safe risk stratification and permitted the non-exclusion of a considerable number of HCP from the vaccination program.
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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.