Allergic adverse events following immunization: Data from post-marketing surveillance in Apulia region (South of Italy).

Introduction: Among adverse events following immunization (AEFIs), allergic reactions elicit the most concern, as they are often unpredictable and can be life-threatening. Their estimates range from one in 1,000,000 to one in 50,000 vaccine doses. This report describes allergic events following immunization reported from 2020 to 2021 in Puglia, a region in the South-East of Italy with around 4 million inhabitants. Its main objective is to describe the allergic safety profile of currently employed vaccines. Materials and methods: This is a retrospective observational study. The study period spanned from January 2020 to December 2021, and the whole Apulian population was included in the study. Information regarding AEFIs reported in Puglia during the study period was gathered from the Italian Drug Authority's pharmacovigilance database (National Pharmacovigilance Network, RNF). The overall number of vaccine doses administered was extrapolated by the Apulian online immunization database (GIAVA). Reporting rates were calculated as AEFIs reported during a certain time span/number of vaccine doses administered during the same period. Results: 10,834,913 vaccine doses were administered during the study period and 95 reports of allergic AEFIs were submitted to the RNF (reporting rate 0.88/100,000 doses). 27.4% of the reported events (26/95) were classified as serious (reporting rate 0.24/100,000 doses). 68 out of 95 (71.6%) adverse events were at least partially resolved by the time of reporting and none of them resulted in the subject's death. Conclusions: Allergic reactions following vaccination were rare events, thus confirming the favourable risks/benefits ratio for currently marketed vaccines.

Prevention of Laboratory Animal Allergy and Impact of COVID-19 on Prevention Programs in the United States: A National Survey 10-Year Update.

OBJECTIVE: Laboratory animal allergy (LAA) is common and preventable. This study provides a 10-year update on LAA prevention programs in the United States and the effect of COVID-19 on prevention practices. METHODS: An electronic survey was e-mailed to designated institutional officials at laboratory animal facilities identified by the National Institutes of Health Office of Laboratory Animal Welfare. Results were compared with the prior survey. RESULTS: A total of 141 institutions employing 58,224 laboratory animal workers responded. Results were similar to the prior survey with wide variation in practices. Medical surveillance increased (58%-71%), but N95 respirator use decreased (17%-13%). As before, only 25% of institutions knew their LAA incidence and prevalence rates. COVID-19 had a small time-limited effect on personal protective equipment use. CONCLUSIONS: Universal use of evidence-based practices and improved medical surveillance would provide greater worker protection from LAA.

Pfizer-BioNTech (BNT162b2), Moderna (mRNA-1273) COVID-19 mRNA vaccines and hypersensitivity reactions.

The SARS-CoV-2 Virus (COVID-19) is responsible for over 239 million cases and 4.8 million deaths globally (Data source WHO COVID-19 Dashboard accessed on October 14, 2021). It continues to surge and ravage countries, leaving healthcare systems in constant struggle and uncertainty. A variety of vaccines were developed to combat the spread of the COVID-19 Virus. Reports of possible allergic reactions with COVID-19 vaccines are a significant cause of public concern, especially among those with a known history of a severe allergic reaction (e.g., anaphylaxis). Here we review articles relevant to COVID-19 vaccines and their excipients (especially PEG (Polyethylene glycol) and hypersensitivity reactions associated with COVID-19 vaccines (including clinical features, pathophysiology, special populations receiving COVID-19 vaccinations, potential diagnostic tests, and preventive measures that can be taken to minimize the risks of hypersensitivity reactions with COVID-19 vaccines).

When Body Art Goes Awry-Severe Systemic Allergic Reaction to Red Ink Tattoo Requiring Surgical Treatment.

The aim of this report is to present a case of a patient who developed unusual systemic hypersensitivity reaction to a red-pigmented tattoo and to discuss diagnostic difficulties in case of systemic reactions to tattoo ink. The patient reported erythroderma on his arms and chest accompanied by plaque elevation of red parts of his most recently performed forearm tattoo as his primary symptoms. His health condition entailed a prolonged topical and intravenous immunosuppressive therapy, which proved ineffective. Over a year after emergence of initial symptoms, he presented to the Plastic Surgery Clinic with generalized erythroderma, systemic lymphadenopathy, elevation and granuloma formation in red tattoos on his forearm and complaints of fatigue and inability to participate fully in work-related and social activities. The patient underwent six staged excisions with direct closures, flap plasties and full-thickness skin grafts. Following completion of each surgical resection, the patient's symptoms gradually subsided. We find this case illustrative of a clinical challenge that delayed hypersensitivity reactions to red tattoos may pose. Furthermore, we provide insights on management of hypersensitivity reactions. This report underlines the importance of social awareness of and public health approach to tattoo complications as key to successful prevention, identification and treatment of adverse reactions to tattoos.

Efficacy and safety of an e-consult program for COVID-19 vaccine allergy concerns.

Background: Although severe allergic reactions to coronavirus disease 2019 (COVID-19) vaccines are rare, fear of allergic reactions remains a major source of vaccine hesitancy. For concerned patients and providers alike, allergist consultation is recommended for further guidance on the risk of vaccination. The electronic consultation (e-consult) medium has the potential to make this guidance more widely accessible, thereby supporting vaccination efforts. Objective: To determine the safety and efficacy of an e-consult program for COVID-19 vaccine allergy concerns. Methods: We performed a retrospective analysis of a single-center COVID-19 vaccine allergy e-consult program. Data on demographics, allergy history, and outcomes after recommendations were gathered via review of the electronic medical record (EMR). Patients without EMR data available following the e-consult were called to inquire about vaccination status. Results: Our study included 64 patients, most of whom (51.6% [33/64]) had e-consults placed for second-dose concerns. E-consults were completed within 2 days for all patients. The most common recommendation was that patients receive any COVID-19 vaccination available (62.5%, [40/64]). Forty-one patients (64.1%) were vaccinated after receiving recommendations from an allergist, 11 of whom (26.8%) reported a vaccine reaction. Most of these reactions were nonallergic (9/11 [81.2%]). No anaphylactic events were reported. Conclusion: Results of our study suggest that e-consults were a safe and effective method of providing guidance with regard to COVID-19 vaccine risk in patients with concerns about allergic reactions. The efficiency of this medium, highlighted by the 2-day turnaround time in our study, has the potential to expand access to vaccine risk evaluations by board-certified allergist/immunologists.

Management of suspected and confirmed COVID-19 (SARS-CoV-2) vaccine hypersensitivity.

BACKGROUND: Systemic allergic reactions to vaccines are very rare. In this study we assessed the management and outcome of suspected SARS-CoV-2 vaccine hypersensitivity. METHODS: Totally, 334 individuals underwent an allergy work up regarding SARS-CoV-2 vaccination (group A: 115 individuals suspected to be at increased risk for vaccine-related reactions before vaccination and group B: 219 patients with reactions after COVID vaccination). The large majority of the SPT/IDT with the vaccines were negative; however, we identified in 14.1% (n = 47) a possible sensitization to the SARS-CoV-2 vaccine and/or its ingredients defined as one positive skin test. Of the 219 individuals (group B) who experienced symptoms suspicious for a hypersensitivity reaction after vaccination, 214 were reported after the first vaccination with a mRNA vaccine (157 mRNA (Comirnaty®, 38 Spikevax®) and 18 with a vector vaccine (Vaxzevria®), 5 cases were after the second vaccination. RESULTS: The symptom profile in group B was as follows: skin symptoms occurred in 115 cases (n = 59 angioedema, n = 50 generalized urticaria and n = 23 erythema/flush. Seventy individuals had cardiovascular, 53 respiratory and 17 gastrointestinal symptoms. Of the overall 334 individuals, 78 patients tolerated (re)-vaccination (out of skin test positive/negative 7/19 from group A and 17/35 from group B). CONCLUSION: Proven IgE-mediated hypersensitivity to SARS-CoV-2 vaccines is extremely rare and not increased in comparison with reported hypersensitivity to other vaccines. The value of skin tests is unclear and nonspecific reactions, in particular when intradermal testing is applied, should be considered.

Hypersensitivity reactions to vaccines in children: from measles to SARS-CoV-2.

Allergic individuals at risk for hypersensitivity reactions to measles vaccine marketed for a long time are well established. On the other hand, risk factors for hypersensitivity reactions to the new mRNA COVID-19 vaccines currently include a history of allergy, allergy to excipient of the vaccine, or hypersensitivity reactions to the first dose of COVID-19 vaccine. In the last two cases, the recipient should be assessed by an allergist before vaccination to share a decision on the choice of vaccination. Studies on skin testing accuracy and desensitization protocols to the COVID-19 vaccines and the efficacy of potential alternatives in patients with confirmed hypersensitivity reactions to the first COVID-19 vaccine are necessary to improve the safety of COVID-19 vaccines.

Utility and futility of skin testing to address concerns surrounding messenger RNA coronavirus disease 2019 vaccine reactions.

BACKGROUND: The mechanism of coronavirus disease 2019 (COVID-19) vaccine hypersensitivity reactions is unknown. COVID-19 vaccine excipient skin testing has been used in evaluation of these reactions, but its utility in predicting subsequent COVID-19 vaccine tolerance is also unknown. OBJECTIVE: To evaluate the utility of COVID-19 vaccine and vaccine excipient skin testing in both patients with an allergic reaction to their first messenger RNA COVID-19 vaccine dose and patients with a history of polyethylene glycol allergy who have not yet received a COVID-19 vaccine dose. METHODS: In this multicenter, retrospective review, COVID-19 vaccine and vaccine excipient skin testing was performed in patients referred to 1 of 3 large tertiary academic institutions. Patient medical records were reviewed after skin testing to determine subsequent COVID-19 vaccine tolerance. RESULTS: A total of 129 patients underwent skin testing, in whom 12 patients (9.3%) had positive results. There were 101 patients who received a COVID-19 vaccine after the skin testing, which was tolerated in 90 patients (89.1%) with no allergic symptoms, including 5 of 6 patients with positive skin testing results who received a COVID-19 vaccine after the skin testing. The remaining 11 patients experienced minor allergic symptoms after COVID-19 vaccination, none of whom required treatment beyond antihistamines. CONCLUSION: The low positivity rate of COVID-19 vaccine excipient skin testing and high rate of subsequent COVID-19 vaccine tolerance suggest a low utility of this method in evaluation of COVID-19 vaccine hypersensitivity reactions. Focus should shift to the use of existing vaccine allergy practice parameters, with consideration of graded dosing when necessary. On the basis of these results, strict avoidance of subsequent COVID-19 vaccination should be discouraged.

Cutaneous and Allergic reactions due to COVID-19 vaccinations: A review.

INTRODUCTION: The pandemic caused by the novel coronavirus disease 2019 (COVID-19) has had an unprecedented impact on the overall health and the global economy. Vaccination is currently the most dependable strategy to end the pandemic, despite the slower-than-hoped-for rollout, particularly for low-to-middle-income countries, and the uncertain duration of protection afforded by vaccination. The spike protein of the virus (immunodominant antigen of the virus) is the main target of the approved and candidate SARS-CoV-2 vaccines. This protein binds to the ACE2 receptor of the host cell, initiating the entry of the virus into the cell and the chain of subsequent events ending to Acute Respiratory Distress Syndrome. The safety profile of these vaccines needs is closely assessed. METHODS: This comprehensive review includes searching the PubMed, EMBASE, and Web of Science databases using the keywords "coronavirus", "COVID-19", "vaccine", "cutaneous reactions", "allergic reactions", and "SARS-CoV-2". Manual searching of reference lists of included articles augmented the research. The research was updated in June 2021. RESULTS: In this narrative review, we tried to investigate and discuss the cutaneous and allergic reactions related to SARS-CoV-2 vaccines currently available in the literature. As a result, although COVID-19 vaccines can be reported to develop allergic and anaphylactic reactions, especially after m-RNA vaccines, they remain at a low rate, and it is observed that these reactions may develop more frequently, especially in patients with previous allergies and mast cell disorders. Fortunately, these reactions are generally transient, benign, self-limited. CONCLUSION: Although there is still no definitive evidence, as dermatologists, we must be aware of the possibility of cutaneous reactions, newly diagnosed dermatoses, or exacerbation of existing dermatoses that may develop after the COVID-19 vaccinations.

Association of Self-reported High-Risk Allergy History With Allergy Symptoms After COVID-19 Vaccination.

Importance: Allergic history in individuals with confirmed anaphylaxis to a messenger RNA (mRNA) COVID-19 vaccine is common. However, the risk factors for allergy symptoms after receiving the vaccine are unknown. Objective: To assess the association between self-reported history of high-risk allergy and self-reported allergic reactions after mRNA COVID-19 vaccination of health care employees. Design, Setting, and Participants: This cohort study obtained demographic, medical, and vaccine administration data of employees of Mass General Brigham from the institutional electronic health record. Employees who received at least 1 dose of an mRNA COVID-19 vaccine between December 14, 2020, and February 1, 2021, and who completed at least 1 postvaccination symptom survey in the 3 days after vaccination were included. Exposures: Self-reported history of high-risk allergy, defined as a previous severe allergic reaction to a vaccine, an injectable medication, or other allergen. Main Outcomes and Measures: The primary outcome was 1 or more self-reported allergic reactions in the first 3 days after dose 1 or dose 2 of an mRNA COVID-19 vaccine. Multivariable log binomial regression was used to assess the association between allergic reactions and high-risk allergy status. Results: A total of 52 998 health care employees (mean [SD] age, 42 [14] years; 38 167 women [72.0%]) were included in the cohort, of whom 51 706 (97.6%) received 2 doses of an mRNA COVID-19 vaccine and 474 (0.9%) reported a history of high-risk allergy. Individuals with vs without a history of high-risk allergy reported more allergic reactions after receiving dose 1 or 2 of the vaccine (11.6% [n = 55] vs 4.7% [n = 2461]). In the adjusted model, a history of high-risk allergy was associated with an increased risk of allergic reactions (adjusted relative risk [aRR], 2.46; 95% CI, 1.92-3.16), with risk being highest for hives (aRR, 3.81; 95% CI, 2.33-6.22) and angioedema (aRR, 4.36; 95% CI, 2.52-7.54). Conclusions and Relevance: This cohort study found that self-reported history of high-risk allergy was associated with an increased risk of self-reported allergic reactions within 3 days of mRNA COVID-19 vaccination. However, reported allergy symptoms did not impede the completion of the 2-dose vaccine protocol among a cohort of eligible health care employees, supporting the overall safety of mRNA COVID-19 vaccine.

Prevalence of Allergic Reactions After Pfizer-BioNTech COVID-19 Vaccination Among Adults With High Allergy Risk.

Importance: Allergic reactions among some individuals who received the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine discourage patients with allergic conditions from receiving this vaccine and physicians from recommending the vaccine. Objective: To describe the assessment and immunization of highly allergic individuals with the BNT162b2 vaccine. Design, Setting, and Participants: In a prospective cohort study from December 27, 2020, to February 22, 2021, 8102 patients with allergies who applied to the COVID 19 vaccine referral center at the Sheba Medical Center underwent risk assessment using an algorithm that included a detailed questionnaire. High-risk patients (n = 429) were considered "highly allergic" and were immunized under medical supervision. Exposures: Pfizer-BioNTech (BNT162b2) COVID-19 vaccine. Main Outcomes and Measures: Allergic and anaphylactic reactions after the first and second doses of BNT162b2 vaccine among highly allergic patients. Results: Of the 429 individuals who applied to the COVID-19 referral center and were defined as highly allergic, 304 (70.9%) were women and the mean (SD) age was 52 (16) years. This highly allergic group was referred to receive immunization under medical supervision. After the first dose of the BNT162b2 vaccine, 420 patients (97.9%) had no immediate allergic event, 6 (1.4%) developed minor allergic responses, and 3 (0.7%) had anaphylactic reactions. During the study period, 218 highly allergic patients (50.8%) received the second BNT162b2 vaccine dose, of which 214 (98.2%) had no allergic reactions and 4 patients (1.8%) had minor allergic reactions. Other immediate and late reactions were comparable with those seen in the general population, except for delayed itch and skin eruption, which were more common among allergic patients. Conclusions and Relevance: The rate of allergic reactions to BNT162b2 vaccine, is higher among patients with allergies, particularly among a subgroup with a history of high-risk allergies. This study suggests that most patients with a history of allergic diseases and, particularly, highly allergic patients can be safely immunized by using an algorithm that can be implemented in different medical facilities and includes a referral center, a risk assessment questionnaire, and a setting for immunization under medical supervision of highly allergic patients. Further studies are required to define more specific risk factors for allergic reactions to the BNT162b2 vaccine.

Diet Intervention Study through Telemedicine Assistance for Systemic Nickel Allergy Syndrome Patients during the COVID-19 Pandemic.

BACKGROUND: Restrictions due to the COVID-19 pandemic limited patients' access to hospital care. The aims of this study were to assess dietary nutritional status, quality of life (QoL), and adherence to dietary therapy before and after 30-day personalized diet therapy through telenutrition tools in patients with systemic nickel allergic syndrome (SNAS). METHODS: Each SNAS patient underwent the following allergological procedures: (a) face-to-face visit (nutritional visit and QoL evaluation) with prescription of one out of five personalized and balanced dietary plans different for calorie intake, (b) video call visit for dietary evaluation and assessment of adherence to diet after 15 days, and (c) video call visit for dietary and QoL evaluation and assessment of adherence to diet therapy after 30 days (end of study). RESULTS: We enrolled 20 SNAS patients. After 15 and 30 days, we found a statistically significant improvement in anthropometric findings after diet therapy, a significant adherence rate to low-nickel diet (60% and 80%, respectively), and an improvement in QoL with an increase in almost all psychometric indices. CONCLUSIONS: Our study demonstrates that telenutrition can be a valid tool to monitor nutritional status and adherence to balanced low-Ni diet positively affecting QoL in SNAS patients during the COVID-19 pandemic.