Allergic History and Anaphylaxis in COVID-19 Vaccines: A Disproportionality Analysis in the FDA Vaccine Adverse Event Reporting System

ABSTRACT

Introduction: Many pre- and post-marketing studies on Covid-19 vaccines investigated their safety in the overall population. Little information is available on cohorts with specific comorbidities. Few studies evaluate the safety in allergic subjects, in particular as related to the anaphylaxis risk. Objective(s) To investigate the association between anaphylaxis after Covid-19 vaccines and the history of hypersensitivity reactions to the most common allergens. Method(s) The Vaccine Adverse Event Reporting System (VAERS, January 2020-December 2021) was downloaded and cleaned. We focused on reports of Adverse Events Following Immunization (AEFIs) following COVID-19 vaccination in subjects>12 years old with history of allergy. We performed a descriptive analysis and calculated the Reporting Odds Ratio (ROR) to identify demographic characteristics and allergic histories disproportionally reported with anaphylaxis for each Covid-19 vaccine and the most recorded allergens. Result(s) We retrieved 183,860 AEFI reports recording any allergic history (864 anaphylaxis reports among cases vs 6,162 in Covid-19 reports without history of allergy). They concerned mostly women (81.3%) and adults (74.0%). Almost all reports were submitted in the US (99.7%) and 38.3% of them resulted in hospitalization. Covid-19 vaccines administered were Spikevax (49.3%), Comirnaty (42.1%), and Janssen (8.4%). The antigens most recorded as allergens were penicillins (49,407), sulfa drugs (37,365), opioids (26,398), seafood (12,039), latex (11,442), NSAIDs (11,319), cephalosporins (8,379), quinolones (8,023), macrolides (7,586). Seafood allergy resulted associated with anaphylaxis for Comirnaty (ROR = 2.80;95% CI 2.20-3.56), Spikevax (2.57;1.88-3.51), and Janssen (2.67;1.39-5.11). Latex allergy was associated with anaphylaxis for Comirnaty (ROR = 1.92;95% CI 1.45-2.55). Conclusion(s) We gathered evidence pointing towards a preferential development of anaphylaxis in patients with an history of hypersensitivity to seafood (for all Covid-19 vaccines) or latex (restricted to Comirnaty). Whether confirmed by further studies, this knowledge may drive a more practical anamnesis and a prompt management of anaphylactic reactions.