Real-life safety profile of mRNA vaccines for COVID-19: An analysis of VAERS database

• DOI: 10.1016/j.vaccine.2023.03.054
• Publication Date: 2023-03-28T15:18:03Z
• Authors: Greta Santi Laurini; Nicola Montanaro; Massimiliano Broc...; Giulia Bonaldo; Domenico Motola
• Keywords: Chills; MedDRA

Since the first COVID-19 messenger RNA vaccines became available globally for emergency or conditional use, post-marketing surveillance activities have been implemented monitoring of any adverse events that might arise in daily clinical practice and were not detected earlier during trials.Safety data concerning BNT162b2 mRNA-1273 collected from Vaccine Adverse Event Reporting System (VAERS) period December 2020 to October 15, 2021. In addition a descriptive analysis individuals who experienced an event after vaccination, case-non-case was performed by using Odds Ratio with 95 % confidence interval as statistical parameter detecting differences reporting rates between two mRNA vaccines.At cut-off date, total 758,040 reports submitted VAERS, which 439,401 related Pfizer-BioNTech (BNT162b2) vaccine 318,639 Moderna (mRNA-1273). Most common following immunization both headache, fatigue, pyrexia, dizziness, nausea, pain, chills, pain extremity. A disproportionality found compared some special interest, such myocarditis [ROR 2.00; (CI), 1.93-2.06], Bell's palsy (1.34; 1.29-1.39), anaphylactic shock (3.23; 2.96-3.53).Even if rare identified, our survey has provided further evidence favourable safety profile vaccines.