Adverse Reactions Following COVID-19 Vaccination Among Ecuadorian Healthcare Workers

NCT05113472 | Completed

• 1 other identifier: 2021-MED-001
• Study Type: observational
• Target: 1,291
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Adverse Drug Event

Keywords

adverse reactions; COVID-19; healthcare workers; Latin America; vaccination

Outcome Measures

Primary Outcomes (1)

• Adverse reactions

  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

Study Arms (1)

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

Interventions

Pfizer-BioNTech COVID-19 vaccine BIOLOGICAL

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

Ecuadorian Healthcare Workers

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Patients who voluntarily refused to participate.

Sponsors & Collaborators

• Respiralab: lead

Study Sites (1)

Universidad Espiritu Santo

Samborondón, 092301, Ecuador

Location

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions; COVID-19

Interventions

BNT162 Vaccine

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

mRNA Vaccines; Nucleic Acid-Based Vaccines; Vaccines, Synthetic; Recombinant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Vaccines; Biological Products; Complex Mixtures; COVID-19 Vaccines; Viral Vaccines; Antigens; Biological Factors

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2021
• First Posted: November 9, 2021
• Study Start: March 1, 2021
• Primary Completion: May 31, 2021
• Study Completion: May 31, 2021
• Last Updated: November 9, 2021

Record last verified: 2021-11

Locations

EC (1)