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Adverse events of COVID-19 vaccines in a university medical service in Bogotá, Colombia
Eventos adversos de vacunas contra la COVID-19 en un servicio médico universitario de Bogotá, Colombia
DOI:
https://doi.org/10.15446/revfacmed.v72n2.111722Palabras clave:
COVID-19, COVID-19 Vaccines, Pharmacovigilance, Drug-Related Side Effects and Adverse Reactions, Colombia, Risk Factors (en)COVID-19, Vacunas contra la COVID-19, Farmacovigilancia, Efectos colaterales y reacciones adversas relacionados con medicamentos, Colombia, Factores de Riesgo (es)
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Introduction: Clinical trials did not provide sufficient data regarding the long-term effects and the potential adverse events of COVID-19 vaccines, especially in countries of the Global South. Active pharmacovigilance allows for an adequate assessment of the risk-benefit ratio of COVID-19 vaccines in uncontrolled settings.
Objectives: To determine the frequency of adverse events following immunization (AEFI) with COVID-19 vaccines in persons enrolled in a university health services unit of Bogotá, Colombia, and to evaluate the risk factors associated with an increased probability of presenting an AEFI.
Materials and methods: An analytical cross-sectional study was conducted in 4 078 individuals enrolled in the Health Services Unit of the Universidad Nacional de Colombia (UNISALUD), Bogotá Campus, who had received at least one dose of COVID-19 vaccines between March 2021 and April 2022. Data were collected through a telephone survey and clinical information provided by UNISALUD. A logistic regression model was developed to evaluate the association between presenting an AEFI and sex, age, type of vaccine, comorbidities, presence or history of allergies, use of concomitant medications, and use of medications and substances to prevent COVID-19.
Results: The mean age of the participants was 69.3 years, 57.14% (n=2 330) were female, and 36. 6% (n=1 495) reported experiencing at least one AEFI (2 477 AEFIs in total), mainly injection site pain (n=754), unspecified pain (n=321), headache (n=301), and fatigue (n=272). Furthermore, Moderna was the vaccine with the highest proportion of participants experiencing AEFIs (77. 42%; 24/31), followed by Janssen (59.60%; 59/99), and Pfizer (49.43%; 783/1 584). The risk factors for presenting an AEFI were: sex (female), age (<65 years), presence or history of allergies, use of hormone therapy, use of azithromycin, history of cardiovascular disease, and vaccine received (Moderna or Pfizer compared with AstraZeneca).
Conclusions: Slightly more than one-third of participants reported experiencing at least one AEFI following the administration of the COVID-19 vaccines, with Moderna being the vaccine with the highest proportion of patients presenting with an AEFI. Age, sex, use of hormone therapy, use of azithromycin, cardiovascular comorbidities, and vaccine received were associated risk factors for the occurrence of AEFIs.
Introducción. Los ensayos clínicos no proporcionaron evidencia suficiente sobre el efecto a largo plazo, ni sobre los posibles eventos adversos de las vacunas contra la COVID-19, en especial en los países del sur global. La farmacovigilancia activa permite realizar una adecuada evaluación de la relación riesgo-beneficio de estas vacunas en contextos no controlados.
Objetivos. Determinar la frecuencia de eventos supuestamente atribuibles a la vacunación o inmunización (ESAVI) de las vacunas contra la COVID-19 en personas afiliadas a una unidad de servicios de salud universitaria de Bogotá, Colombia, y evaluar los factores de riesgo asociados a una mayor probabilidad de presentar ESAVI.
Materiales y métodos. Estudio transversal analítico realizado en 4 078 personas afiliadas a la Unidad de Servicios de Salud de la Universidad Nacional de Colombia (UNISALUD), sede Bogotá, que habían recibido al menos una dosis de vacunas contra la COVID-19 entre marzo de 2021 y abril de 2022. Los datos fueron recolectados a través de una encuesta telefónica e información clínica provista por UNISALUD. Se desarrolló un modelo de regresión logística para evaluar la asociación entre presentar ESAVI y sexo, edad, vacuna recibida, presencia o antecedente de alergias, uso de medicamentos concomitantes, existencia de comorbilidades y consumo de medicamentos y sustancias para prevenir la COVID-19.
Resultados. La edad promedio de los participantes fue 69.3 años, 57.14% (n=2 330) eran mujeres y 36.6% (n=1 495) indicaron haber presentado al menos un ESAVI (2 477 ESAVI en total), principalmente dolor en el lugar de la inyección (n=754), dolor no especificado (n=321), cefalea (n=301) y fatiga (n=272); además, Moderna fue la vacuna con la mayor proporción de participantes que sufrió ESAVI (77.42%; 24/31), seguida de Janssen (59.60%; 59/99) y Pfizer (49.43%; 783/1 584). Los factores de riesgo para presentar ESAVI fueron: sexo (femenino), edad (<65 años), presencia o antecedente de alergias, uso de terapia hormonal, uso de azitromicina, padecimiento de enfermedad cardiovascular y la vacuna recibida (Moderna o Pfizer comparadas con AstraZeneca).
Conclusiones. Un poco más de un tercio de los participantes reportaron al menos un ESAVI luego de la administración de las vacunas contra la COVID-19, siendo Moderna la vacuna con la que hubo una mayor proporción de pacientes que presentaron ESAVI. La edad, el género, el uso de terapia hormonal, el uso de azitromicina, las comorbilidades cardiovasculares y la vacuna recibida se asociaron como factores de riesgo para la aparición de ESAVI.
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