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

Margitta Worm, Aikaterina Alexiou, Andrea Bauer, Regina Treudler, Gerda Wurpts, Heinrich Dickel, Timo Buhl, Sabine Müller, Andreas Jung, Randolf Brehler, Joachim Fluhr, Ludger Klimek, Norbert Mülleneisen, Wolfgang Pfützner, Ulrike Raap, Stefani Roeseler, Sandra Schuh, Hartmut Timmermann, Guido Heine, Bettina WediKnut Brockow

Research output: Contribution to journalArticlepeer-review

15 Scopus citations


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.

Original languageEnglish
Pages (from-to)3426-3434
Number of pages9
JournalAllergy: European Journal of Allergy and Clinical Immunology
Issue number11
StatePublished - Nov 2022
Externally publishedYes


  • SARS-CoV-2
  • anaphylaxis
  • hypersensitivity
  • polyethylene glycol
  • vaccination


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