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OpenTrials
Completed

NCT Number: NCT05113472

Adverse Reactions Following COVID-19 Vaccination Among Ecuadorian Healthcare Workers

Limited large-scale studies have been conducted to investigate the adverse effects of COVID-19 vaccine in Latin America, particularly among the healthcare worker (HCW) population in Ecuador. The objective of this study was to assess a cohort of Ecuadorian healthcare workers for adverse reactions following vaccination with the Pfizer-BioNTech vaccine.

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Key information

Conditions

Adverse Drug Event COVID-19 Chemically-Induced Disorders Coronaviridae Infections Coronavirus Infections Drug-Related Side Effects and Adverse Reactions Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Universidad Espiritu Santo

Samborondón, 092301, Ecuador

About this study

The COVID-19 pandemic bears a burden on medical care and economies worldwide, however immunization at the population level provides a way for to reduce future morbidity and mortality. Vaccine hesitancy and reluctance in getting the COVID-19 vaccine and apprehensions about them have been present along the course of vaccination programs and mass immunizations across the world. Factors such as the quick, large-scale production of vaccines, lack of information, and uncertainty about adverse reactions in the public's eye as well about myths spreading through media channels have given rise to suspicion and fear in the Latin American population. Limited large-scale studies have been conducted to investigate the adverse effects of COVID-19 vaccine in Latin America, particularly among the healthcare worker (HCW) population in Ecuador. The objective of this study was to assess a cohort of Ecuadorian healthcare workers for adverse reactions following vaccination with the Pfizer-BioNTech vaccine.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ecuadorian nationality
  • Active practice in the medical field
  • Received the Pfizer-BioNTech COVID-19 vaccine

Exclusion criteria

  • Patients who voluntarily refused to participate.

Treatment and study plan

Pfizer-BioNTech COVID-19 Vaccine

Biological

Patients who were administered any dose of the Pfizer-BioNTech COVID-19 vaccine.

Primary outcomes

  1. Adverse reactions

    Time frame: 14 days since administration of either dose

    Pain, erythema, edema, pruritus, axillary edema, fever, cephalea, malaise, arthralgia, nausea, diarrhea, chills, fatigue, somnolence, syncope, paresthesia, anxiety, dizziness, epigastric pain, generalized rash, generalized pruritus, allergic rhinitis, petechiae, throat itchiness, allergic sinusitis, facial edema, bronchospasm, allergic conjunctivitis, dermatitis, eczema, ocular edema, urticaria, lip swelling, tongue swelling, facial rash, anaphylaxis.

Sponsors and collaborators

Lead sponsor

Respiralab

Other

Registry information

Official study title

Adverse Reactions Following COVID-19 Vaccination: an Ecuadorian Experience

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Nov 9, 2021
Registry last updated
Nov 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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