Optimizing the Clinical Management of Patients with Adverse Events Following COVID-19 Vaccination and Potential Contraindications to Vaccination in the Special Immunization Clinic Network
Networks
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Datasets
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Variables
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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.
- Start Year
- 2021
Visit SIC
| Investigators | Contacts |
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Design
- Study design
- Cohort
- Follow Up
- Participants are followed up each time they are vaccinated or revaccinated and each time an adverse event following immunization occurs.
Recruitment
- Recruitment Target
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- Individuals
Number of Participants
- 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
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
- Newborns
- Twins
- Countries
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- Canada
- Territory
- Halifax, Quebec City, Montreal, Sherbrooke, Ottawa, Toronto, Hamilton, Saskatoon, Edmonton, Calgary, Vancouver
- Ethnic Origin
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- Health Status
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- 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.
Recruitment
- Sources of recruitment
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- Specific population
- Specific Population
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- Clinic patients
- Supplementary Information
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Participants are referred to the study by a healthcare provider (physician, nurse practitioner, public health physician).
Number of Participants
- Number of Participants
- Number of Participants with Biological Samples
Data Collection Events
| # | Name | Description | Start | End |
|---|---|---|---|---|
| 0 |
SIC - No underlying medical conditions - Clinical assessment
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Information was or will be collected on patient demographic characteristics (age at the date of vaccination, gender), past medical history, comorbidities, known allergies and medication history, ... | 2021 | |
| 1 |
SIC - No underlying medical conditions - Revaccination
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Information was or will be collected about the physician's recommendation for revaccination, participant revaccination intent, revaccination status (location), the occurrence of any adverse events ... | 2021 | |
| 2 |
SIC - No underlying medical conditions - Post-revaccination
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Information was or will be collected about the diagnosis, relative severity or seriousness, and outcome of the adverse event following immunization. | 2021 | |
| 3 |
SIC - No underlying medical conditions - Adverse event recurrences
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Information was or will be collected about the reoccurrence of adverse events following immunization (AEFIs) in the population and the relative severity of the recurrent AEFI compared to the ... | 2021 |
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
- Newborns
- Twins
- Countries
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- Canada
- Territory
- Halifax, Quebec City, Montreal, Sherbrooke, Ottawa, Toronto, Hamilton, Saskatoon, Edmonton, Calgary, Vancouver
- Ethnic Origin
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- Health Status
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- 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.
Recruitment
- Sources of recruitment
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- Specific population
- Specific Population
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- Clinic patients
- Supplementary Information
-
Participants are referred to the study by a healthcare provider (physician, nurse practitioner, public health physician).
Number of Participants
- Number of Participants
- Number of Participants with Biological Samples
Data Collection Events
| # | Name | Description | Start | End |
|---|---|---|---|---|
| 0 |
SIC - Underlying medical conditions - Clinical assessment
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Information was or will be collected on age, gender, past medical history, comorbidities, known allergies and medication history, history of symptomatic or asymptomatic SARS-CoV-2 infection or ... | 2021 | |
| 1 |
SIC - Underlying medical conditions - Vaccination
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Information was or will be collected about the vaccine administered (brand name, dose number, route, anatomical site), vaccination status (location), participant vaccination intent, and the ... | 2021 | |
| 2 |
SIC - Underlying medical conditions - Post-vaccination
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Information was or will be collected about the diagnosis, relative severity or seriousness, and outcome of any adverse event following immunization (e.g., recovered, not yet recovered but expected ... | 2021 | |
| 3 |
SIC - Underlying medical conditions - Adverse event recurrences
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Information was or will be collected about the reoccurrence of adverse events following immunization (AEFIs) in the population and the relative severity of the recurrent AEFI compared to the ... | 2021 |
Classifications
- Socio-demographic and economic characteristics
- Lifestyle and behaviours
- Birth, pregnancy and reproductive health history
- Perception of health, quality of life, development and functional limitations
- Diseases
- Symptoms and signs
- Medication and supplements
- Non-pharmacological interventions
- Health and community care services utilization
- Death
- Physical measures and assessments
- Laboratory measures
- Cognition, personality and psychological measures and assessments
- Life events, life plans, beliefs and values
- Preschool, school and work life
- Social environment and relationships
- Physical environment
- Administrative information
Socio-demographic and economic characteristics
Age/birthdate
Sex/gender
Ethnicity, race and religion
Birth, pregnancy and reproductive health history
Pregnancy, delivery and birth
Perception of health, quality of life, development and functional limitations
Functional limitations
Diseases
Certain infectious and parasitic diseases (A00-B99)
Neoplasms (C00-D48)
Diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism (D50-D89)
Endocrine, nutritional and metabolic diseases (E00-E90)
Mental and behavioural disorders (F00-F99)
Diseases of the nervous system (G00-G99)
Diseases of the eye and adnexa (H00-H59)
Diseases of the circulatory system (I00-I99)
Diseases of the respiratory system (J00-J99)
Diseases of the digestive system (K00-K93)
Diseases of the skin and subcutaneous tissue (L00-L99)
Diseases of the musculoskeletal system and connective tissue (M00-M99)
Diseases of the genitourinary system (N00-N99)
Injury, poisoning and certain other consequences of external causes (S00-T98)
Diseases without precise specification or falling into multiple categories
Symptoms and signs
Symptoms and signs involving the circulatory and respiratory systems (R00-R09)
Symptoms and signs involving the digestive system and abdomen (R10-R19)
Symptoms and signs involving the skin and subcutaneous tissue (R20-R23)
Symptoms and signs involving nervous and musculoskeletal systems (R25-R29)
Symptoms and signs involving cognition, perception, emotional state and behaviour (R40-R46)
Symptoms and signs involving speech and voice (R47-R49)
General symptoms and signs (R50-R69)
Symptoms related to multiple categories
Medication and supplements
Medication and supplement intake
Posology and protocol of administration
Non-pharmacological interventions
Surgical interventions
Other and unspecified non-pharmacological interventions
Health and community care services utilization
Visits to health professionals
Hospitalizations
Community and social care
Physical measures and assessments
Anthropometry
Brain and nerves
Other physical measures and assessments
Laboratory measures
Hematology
Biochemistry
Microbiology
Virology
Immunology
Other laboratory measures
Physical environment
Biological exposure
Administrative information
Date and time-related information
Physical and cognitive measure and biosample-related information
Other administrative information