Adverse Reactions Following COVID-19 Vaccination Among Ecuadorian Healthcare Workers

Completed

• Conditions: Adverse Drug Event
• Interventions: Biological: Pfizer-BioNTech COVID-19 vaccine

• Registration Number: NCT05113472
• Lead Sponsor: Respiralab

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.

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 Timeline

• Study Start: 2021-03-01
• Primary Completion: 2021-05-31
• Study Completion: 2021-05-31
• Status Verified: 2021-11
• Study First Submitted: 2021-11-08
• Study First Submitted QC: 2021-11-08
• Last Update Submitted: 2021-11-08
• Study First Posted: 2021-11-09
• Last Update Posted: 2021-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1291

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ecuadorian Healthcare Workers	Pfizer-BioNTech COVID-19 vaccine	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.

Primary Outcome Measures

Name	Time	Method
Adverse reactions	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.

Trial Locations

Locations (1)

Universidad Espiritu Santo; 🇪🇨 Samborondon, Ecuador