Adverse Reactions Following COVID-19 Vaccination Among Ecuadorian Healthcare Workers

Study Overview
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Brief Summary
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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
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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.

Official Title
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Adverse Reactions Following COVID-19 Vaccination: an Ecuadorian Experience

Conditions
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Adverse Drug Event

Intervention / Treatment
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* Biological: Pfizer-BioNTech COVID-19 vaccine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ecuadorian Healthcare Workers<br>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<br>* Patients who were administered any dose of the Pfizer-BioNTech COVID-19 vaccine.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adverse reactions, COVID-19, healthcare workers, Latin America, vaccination