Optimizing the Clinical Management of Patients with Adverse Events Following COVID-19 Vaccination and Potential Contraindications to Vaccination in the Special Immunization Clinic Network
The main objectives of this study are:
* To describe the clinical presentation, severity and outcomes of patients with adverse events following immunization (AEFIs) of special interest following COVID-19 vaccination.
* To estimate the risk of AEFI recurrence following revaccination with COVID-19 vaccines.
The exploratory objectives of this study are:
* To identify risk factors for AEFIs of special interest following COVID-19 vaccination.
* To assess the safety of COVID-19 vaccination in patients with underlying medical conditions that may complicate vaccination.
Overview
- Acronym
- SIC
- Website
- SIC
- Investigators
-
General Design
- Study design
- Cohort
- Start - End Year
- 2021 -
- General Information on Follow Up (profile, frequency)
-
Participants are followed up each time they are vaccinated or revaccinated and each time an adverse event following immunization occurs.
- Recruitment Target
-
- Individuals
- Number of Participants
- 514
- Number of Participants with Biological Samples
- 200
Access
Availability of data and biosamples
| Possible Access to Data | |
| Possible Access to Biosamples | |
| Other |
|
Timeline
Populations
SIC – No underlying medical conditions
The population is composed of patients with no underlying medical conditions who received at least one dose of a COVID-19 vaccine and experienced rare and medically significant adverse events following immunization (AEFIs) without an alternate cause for their symptoms.
Selection Criteria
- Countries
-
- Canada
- Canadian Provinces
-
- Alberta
- British Columbia
- Nova Scotia
- Ontario
- Quebec
- Saskatchewan
- Territory
- Halifax, Quebec City, Montreal, Sherbrooke, Ottawa, Toronto, Hamilton, Saskatoon, Edmonton, Calgary, Vancouver
- Health Status
-
- Participants are included if they experienced any of the following adverse effects after receiving a COVID-19 vaccine: anaphylaxis (onset <24 hours after immunization), immediate hypersensitivity (onset <4 hours after immunization), type III or IV hypersensitivity reactions, severe cutaneous or systemic reactions (e.g., Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis), seizure or significant worsening of seizures in those with an underlying seizure disorder, Guillain-Barré Syndrome, acute disseminated encephalomyelitis, transverse myelitis or other suspected demyelinating condition, aseptic meningitis, encephalitis, thrombocytopenia, deep vein thrombosis, pulmonary embolism, stroke, heart failure and cardiogenic shock, cardiomyopathy, arrhythmia, myocarditis, pericarditis, acute kidney injury, acute liver injury, acute respiratory distress syndrome, other severe local or systemic symptoms causing work/school absenteeism or significant decline in function, mobility or cognition and requiring immediate medical attention, or severe COVID-19 requiring hospitalization with onset >2 weeks post-immunization.
- Other Criteria
- Patients with vaccine hesitancy or concerns will be excluded from the study.
Sources of Recruitment
- Specific Population
-
- Clinic patients
- Supplementary Information
-
Participants are referred to the study by a healthcare provider (physician, nurse practitioner, public health physician).
Data Collection Events
| # | Name | Data sources | Data sources - Biosamples | Start | End |
|---|---|---|---|---|---|
| 0 | SIC - No underlying medical conditions - Clinical assessment |
|
|
2021 | Ongoing |
| 1 | SIC - No underlying medical conditions - Revaccination |
|
2021 | Ongoing | |
| 2 | SIC - No underlying medical conditions - Post-revaccination |
|
2021 | Ongoing | |
| 3 | SIC - No underlying medical conditions - Adverse event recurrences |
|
2021 | Ongoing |
SIC – Underlying medical conditions
The population is composed of patients with underlying medical conditions who are hypersensitive to a component of a COVID-19 vaccine and require a pre-vaccination assessment.
Selection Criteria
- Countries
-
- Canada
- Canadian Provinces
-
- Alberta
- British Columbia
- Nova Scotia
- Ontario
- Quebec
- Saskatchewan
- Territory
- Halifax, Quebec City, Montreal, Sherbrooke, Ottawa, Toronto, Hamilton, Saskatoon, Edmonton, Calgary, Vancouver
- Health Status
-
- Patients with underlying medical conditions who are hypersensitive to a component of a COVID-19 vaccine and require a pre-vaccination assessment
- Other Criteria
- Patients with vaccine hesitancy or concerns will be excluded from the study.
Sources of Recruitment
- Specific Population
-
- Clinic patients
- Supplementary Information
-
Participants are referred to the study by a healthcare provider (physician, nurse practitioner, public health physician).
Data Collection Events
| # | Name | Data sources | Data sources - Biosamples | Start | End |
|---|---|---|---|---|---|
| 0 | SIC - Underlying medical conditions - Clinical assessment |
|
|
2021 | Ongoing |
| 1 | SIC - Underlying medical conditions - Vaccination |
|
2021 | Ongoing | |
| 2 | SIC - Underlying medical conditions - Post-vaccination |
|
2021 | Ongoing | |
| 3 | SIC - Underlying medical conditions - Adverse event recurrences |
|
2021 | Ongoing |
Participating Studies
| Acronym | Name | Study design | Countries |
|---|
Harmonization Initiatives Included
| Acronym | Name |
|---|
Datasets
| Name | Data Collection Events | Variables |
|---|
Areas of Information Collected
- Socio-demographic and economic characteristics
- Death
- Lifestyle and behaviours
- Physical measures and assessments
- Birth, pregnancy and reproductive health history
- Laboratory measures
- Perception of health, quality of life, development and functional limitations
- Cognition, personality and psychological measures and assessments
- Diseases
- Life events, life plans, beliefs and values
- Symptoms and signs
- Preschool, school and work life
- Medication and supplements
- Social environment and relationships
- Non-pharmacological interventions
- Physical environment
- Health and community care services utilization
- Administrative information
Variables Content Summary
Areas of Information Collected
No Areas of Information Collected
No Scales Collected
Areas of Information Collected per per Population and Data Collection Event
No Areas of Information Collected
No Scales Collected
Networks
| Acronym | Name | Harmonization Initiatives | Individual Studies |
|---|
Last Update: 2022-02-09T17:42:22.533