Allergic reactions to coronavirus disease 2019 vaccines and addressing vaccine hesitancy

Abstract

Background: Allergic and nonallergic adverse reactions have been reported with global coronavirus disease 2019 (COVID-19) vaccination. It was previously hypothesized that polyethylene glycol (PEG) may be responsible for anaphylactic reactions to mRNA COVID-19 vaccines. Objective: To report the workflow established at our institution, types, and frequency of adverse reactions to mRNA COVID-19 vaccines in patients presenting for allergy evaluation. Methods: A COVID-19 vaccines adverse reactions registry was established. We used PEG prick skin testing, followed by PEG challenges in selected cases, to ensure PEG tolerance and encourage completion of COVID-19 vaccination series. Results: A total of 113 patients were included. Most vaccine reactions (86.7%) occurred in women. Anaphylaxis occurred only in women, all of which had a history of allergic disease and two-thirds had asthma. Anaphylaxis rate was 40.6 cases per million. None of the anaphylactic cases developed hypotension, required intubation or hospital admission. Systemic allergic symptoms, not fulfilling anaphylaxis criteria were significantly more common in Pfizer-BioNTech than Moderna vaccinated patients (p=0.02). We observed a higher incidence of dermatologic non-urticarial reactions in men (p=0.004). Among first dose reactors, 86.7% received and tolerated second dose. We observed a high rate of false positive intradermal skin tests and frequent subjective symptoms with oral PEG challenge. Conclusion: Intradermal PEG testing has limited utility in evaluating anaphylaxis to mRNA vaccines. Most severe postvaccination allergic symptoms are not caused by hypersensitivity to PEG. The majority of people with reaction to the initial mRNA vaccine can be safely revaccinated. Patients with anaphylaxis to COVID-19 vaccines benefit from physician-observed vaccination.

Cutaneous adverse reactions following COVID‐19 vaccinations: A systematic review and meta‐analysis

“…The majority of studies were cross‐sectional in design (22 studies), 11 , 12 , 13 , 14 , 15 , 16 , 17 , 18 , 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 followed by cohort (13 studies 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 ) and case–control (one study 46 ) studies, respectively. Most of the studies were carried out in Europe (14 studies), followed by Eastern Asia (6 studies), Western Asia (5 studies), North America (4 studies), and South America (2 studies), respectively.…”

A systemic review and recommendation for an autopsy approach to death followed the COVID 19 vaccination

“… Ⓛ 5 Pfizer US 18-80 1 st , 2 nd 1271 persons Anaphylaxis(1) 7×10 -4 Kadali et al [24] Ⓛ Ⓛ Ⓛ ? Ⓛ Ⓗ Ⓛ 6 Pfizer US 19-89 1 st , 2 nd 62 cases Anaphylaxis(62) - Kaplan et al [25] Ⓛ Ⓛ Ⓛ Ⓛ Ⓛ Ⓛ Ⓛ 7 Pfizer US >16 2 nd 18801 Anaphylaxis(1) 1×10 -5 Clinical Trial data by FDA [26] Ⓛ Ⓛ ? ?…”

“… Ⓛ ? Ⓛ 27 Moderna US 19-89 1 st , 2 nd 50 cases Anaphylaxis(50) - Kaplan et al [25] NA NA NA NA NA NA NA 28 Moderna Canada >25 NS 152876 doses Anaphylaxis(5) 3×10 -5 Ontario public health agency [29] Ⓛ Ⓛ ? ?…”

“… Ⓛ 32 Janssen US >16 1 dose 28745 persons Anaphylaxis(58) 0.002 A Singh et al [21] Ⓛ Ⓛ Ⓛ ? Ⓛ Ⓗ Ⓛ 33 Janssen US 19-89 1 dose 1 case Anaphylaxis(1) - Kaplan et al [25] NA NA NA NA NA NA NA Abbreviation: AZ, AstraZeneca; CDC, center of disease control and prevention; F, female; FDA, food and drug administration; M, Male; MHRA, Medicine and healthcare products regulatory agency; NS, not specified; PEG, Polyethylene Glycol; Ⓛ, low risk; Ⓗ, high risk; NA, not applicable. …”

Anaphylaxis and Related Events Following COVID‐19 Vaccination: A Systematic Review

“…Only 41 studies met our inclusion criteria 22,61–100 ; these consisted of 18 case series/reports, 18 cohort studies without control groups, and 4 cohort studies with control groups, one of which was a double‐blinded randomized clinical trial. The last study, Kaplan et al, 79 contained both a cohort analysis and a case series.…”