Sex, Age, and COVID-19 Vaccine Characteristics Associated with Adverse Events After Vaccination and Severity: A Retrospective Analysis.

Abstract

Background: Although the safety of COVID-19 vaccines has been demonstrated in clinical trials, real-world pharmacovigilance remains essential to detect rare or unexpected adverse events following immunization (AEFI). In Mexico, the national AEFI surveillance system is in place, yet there is limited analysis of state-level data.

Objective: To characterize AEFI related to five COVID-19 vaccines and identify factors associated with AEFI type and seriousness in Nuevo León, Mexico.

Methods: A retrospective analysis of the State of Nuevo León AEFI database was conducted, including all AEFI reports between December 2020 and June 2022 (n = 2213). Data included patient sex, age, vaccine type (Pfizer/BioNTech, AstraZeneca, Sinovac, Moderna, CanSino), number of doses (1 or ≥2), symptom categories, and AEFI seriousness. Symptoms were classified as local or systemic and grouped by organ systems. Descriptive analysis and binary multivariate logistic regression were used to examine associations between demographic and vaccine-related factors with AEFI type and severity. Odds ratios (OR) with 95% confidence intervals (CI) were estimated.

Results: Most AEFI reports involved females aged 19-59 years and occurred after the first vaccine dose. The most frequently reported unexpected adverse events (UAEs) were mild to moderate, including injection-site reactions, headache, chills, fatigue, nausea, fever, dizziness, weakness, myalgia, and tachycardia. The Pfizer/BioNTech vaccine was associated with higher odds of arm pain and lower odds of hemorrhagic events. Receiving ≥2 doses increased the odds of arm pain and systemic symptoms. Less than 3% of AEFIs were classified as serious. Older adults (≥65 years) and second vaccine doses were associated with increased odds of a serious AEFI, while female sex and receiving the Pfizer/BioNTech vaccine were associated with reduced odds.

Conclusions: In Nuevo León, most AEFIs related to COVID-19 vaccination were mild to moderate and resolved without complications. Serious AEFIs were uncommon, with older age and second doses associated with higher risk, and female sex and Pfizer/BioNTech vaccination associated with lower risk. These findings provide a local perspective on vaccine safety that complements national and international evidence.