Adverse effects to the Pfizer-BioNTech vaccine in staff of a tertiary hospital

Authors

  • Mario Alberto Ramírez Camacho Universidad Autónoma de Yucatán
  • Abraham Arcos-Díaz High Specialty Regional Hospital, Institutional Pharmacovigilance Center, Mérida, Mexico
  • Darwin Stalin Torres-Erazo Regional High Specialty Hospital, Infectious Diseases and Epidemiological Surveillance Unit, Mérida, Mexico https://orcid.org/0000-0001-9049-9199
  • Kyra Angélica Argáez-Ojeda High Specialty Regional Hospital, Department of Internal Medicine, Mérida, Mexico https://orcid.org/0009-0006-8800-2159
  • Patricia del Carmen Marín-Alvarado High Specialty Regional Hospital, Institutional Pharmacovigilance Center, Mérida, Mexico https://orcid.org/0000-0001-7541-0934
  • Julio César Lara-Riegos Autonomous University of Yucatán, Faculty of Chemistry, Laboratory of Biochemistry and Molecular Genetics, Mérida, Mexico https://orcid.org/0000-0002-5642-8255

DOI:

https://doi.org/10.30827/ars.v66i1.31090

Keywords:

Vaccines, COVID-19, Adverse reactions and side events related to drugs, Pharmacovigilance

Abstract

Introduction: One of the vaccines to combat the COVID-19 coronavirus pandemic was the RNA-messenger vaccine developed by Pfizer-BioNTech. In early 2021, hospital workers in Mexico received two doses of this vaccine. The objective of this study was to determine the frequency of adverse events (AE) to the Pfizer-BioNTech vaccine in a cohort of staff at a tertiary hospital in southeastern Mexico and to identify factors associated with the development of AE.

Method: Cross-sectional, observational and descriptive study carried out in the staff of a tertiary hospital. AE’s were identified through active surveillance and telephone follow-up between the second and fifteenth day after the first and second immunization. Demographic and clinical data were captured in an electronic database.

Results: A total of 1033 subjects were surveyed, with a mean age of 39.04±9.20 years and 53.4% female. 94.5% of subjects experienced at least one AE after administration of the Pfizer-BioNTech vaccine. A total of 2805 AEs were detected (1360 first dose and 1445 second dose). The most frequently reported AEs at both doses were application site pain, headache, fatigue and pyrexia.

Conclusions: The frequency of AEs in the present study was consistent with previous reports for the Pfizer-BioNTech vaccine. AEs were mild and transient showing good tolerability. Female sex, having a chronic-degenerative disease and a history of allergy were significantly associated with the presence of any AE.

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Author Biographies

Abraham Arcos-Díaz, High Specialty Regional Hospital, Institutional Pharmacovigilance Center, Mérida, Mexico

Pharmaceutical Chemist Biologist, Head of the Institutional Pharmacovigilance Center.

Darwin Stalin Torres-Erazo, Regional High Specialty Hospital, Infectious Diseases and Epidemiological Surveillance Unit, Mérida, Mexico

Physician Specialist in Internal Medicine and Infectious Diseases

Kyra Angélica Argáez-Ojeda, High Specialty Regional Hospital, Department of Internal Medicine, Mérida, Mexico

Surgeon, specialist in internal medicine

Patricia del Carmen Marín-Alvarado, High Specialty Regional Hospital, Institutional Pharmacovigilance Center, Mérida, Mexico

MASTER IN ENVIRONMENTAL ENGINEERING, Biological Pharmaceutical Chemistry

Julio César Lara-Riegos, Autonomous University of Yucatán, Faculty of Chemistry, Laboratory of Biochemistry and Molecular Genetics, Mérida, Mexico

PhD in sciences, specialist in Biochemistry and molecular biology Chemistry

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Published

2024-12-20

How to Cite

1.
Ramírez Camacho MA, Arcos-Díaz A, Torres-Erazo DS, Argáez-Ojeda KA, Marín-Alvarado P del C, Lara-Riegos JC. Adverse effects to the Pfizer-BioNTech vaccine in staff of a tertiary hospital. Ars Pharm [Internet]. 2024 Dec. 20 [cited 2024 Dec. 22];66(1):36-45. Available from: https://revistaseug.ugr.es/index.php/ars/article/view/31090

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Section

Original Articles