Adverse Reactions Following COVID-19 Vaccination Among Ecuadorian Healthcare Workers

Adverse Drug Event Clinical Trial

Official title:

Adverse Reactions Following COVID-19 Vaccination: an Ecuadorian Experience

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05113472
• Other study ID #: 2021-MED-001
• Status: Completed
• Start date: March 1, 2021
• Est. completion date: May 31, 2021

Study information

• Verified date: November 2021
• Source: Respiralab
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1291
• Est. completion date: May 31, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adverse Drug Event
• COVID-19
• Drug-Related Side Effects and Adverse Reactions

Intervention

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

Locations

Country	Name	City	State
Ecuador	Universidad Espiritu Santo	Samborondon

Sponsors (1)

Lead Sponsor	Collaborator
Respiralab

Country where clinical trial is conducted

Ecuador, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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