Hypersensitivity reactions to SARS-CoV- 2 vaccines reported in Latvia

ABSTRACT

Background: SARS-CoV- 2 infection remains a significant global concern. Since vaccination is one of the most effective methods of severe disease prevention, the question of its side effects is substantial. Therefore, collaboration between clinicians and the Pharmacovigilance department of the national competent authority is important and can provide essential information on this matter. Method(s) Spontaneous reports of adverse drug reactions received by the State Agency of Medicines of Latvia between 2021-01- 01 and 2022-01- 05 were reviewed to identify cases of hypersensitivity reactions. MedDRA Queries were used for data selection. In data analysis, descriptive statistics were used. Result(s) A total 90 possible hypersensitivity reactions were selected for analysis, of which 34 cases (37.8%) were reported by healthcare professionals and 56 cases (62.2%) by patients. 12 cases (13.3%) were anaphylaxis, 10 (11.1%) were immediate type reactions and 68 (75.6%) were potential delayed type reactions, among them 66 cases were possible type IV and 2 cases possible type III reactions. 70 patients (78.7%) were women and 19 (21.3%) were men. The mean age of patients was 43.13 +/- 15.9 (17-80) years old. 21 patients (23.3%) received Vaxzevria, 16 (17.8%) Janssen, 39 (43.3%) Comirnaty and 14 (15.6%) Spikevax. The most commonly reported symptoms in the anaphylaxis group was impaired consciousness (33.3%), angioedema (33.3%), skin erythema (25%), urticaria (25%), hypotension (25%), tachycardia (25%), nausea and vomiting (25%), in the immediate type reaction group dyspnoe (40%), skin erythema (30%), angioedema (30%), skin pruritus (20%), unspecified skin rash (20%), dizziness (20%), and in the delayed type reaction group skin rash (92.6%), pruritus (25%), injection site reaction (23.5%). There were only eight patients with prior history of allergies. Conclusion(s) More than a half of the spontaneously reported cases of hypersensitivity reactions selected for the analysis were submitted by patients. Vast majority of all selected cases concerned women. Individuals who were affected by hypersensitivity reactions after COVID-19 vaccination were more likely to experience delayed-type than immediate-type reactions. Although, it should be considered that underreporting might be in place.