Adverse Reactions Following COVID-19 Vaccination Among Ecuadorian Healthcare Workers

November 8, 2021 updated by: Respiralab

Adverse Reactions Following COVID-19 Vaccination: an Ecuadorian Experience

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

1291

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ecuador
      • Samborondon, Ecuador, 092301
        • Universidad Espíritu Santo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The population included Ecuadorian healthcare workers who received the inoculation with the Pfizer-BioNTech COVID-19 vaccine.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Ecuadorian Healthcare Workers
All individuals involved were part of the first phase of the national COVID-19 vaccination plan in our country and were contacted through a local registry established by a local private university.
Biological: Pfizer-BioNTech COVID-19 vaccine
Patients who were administered any dose of the Pfizer-BioNTech COVID-19 vaccine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
14 days since administration of either dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Respiralab

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2021

Primary Completion (ACTUAL)

May 31, 2021

Study Completion (ACTUAL)

May 31, 2021

Study Registration Dates

First Submitted

November 8, 2021

First Submitted That Met QC Criteria

November 8, 2021

First Posted (ACTUAL)

November 9, 2021

Study Record Updates

Last Update Posted (ACTUAL)

November 9, 2021

Last Update Submitted That Met QC Criteria

November 8, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-MED-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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