Maelstrom Research Staging | SIC_No_underlying_medical_conditions_Clinical

SIC_No_underlying_medical_conditions_Clinical_assessment

Networks -

Variables -

Population

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

Newborns

Twins

Countries

Canada

Territory

Halifax, Quebec City, Montreal, Sherbrooke, Ottawa, Toronto, Hamilton, Saskatoon, Edmonton, Calgary, Vancouver

Ethnic Origin

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.

Recruitment

Sources of recruitment

Specific population

Specific Population

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

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Data Collection Event

SIC - No underlying medical conditions - Clinical assessment

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, history of symptomatic or asymptomatic SARS-CoV-2 infection or contact with COVID-19, and vaccine(s) administered (brand name, dose number, route, anatomical site). Information was or will be also collected about the adverse event following immunization (AEFI) such as the diagnosis and level of certainty of diagnosis, seriousness or severity of AEFI, the symptoms reported, the interval between vaccination and symptom onset, symptom duration, the causal relationship between the vaccine and the adverse event, medications given prior to immunization, antecedent illness, the treatment, the outcome (e.g., recovered, not yet recovered but expected to recover, permanent disability), and the risk-benefit ratio of revaccination. Physical measures included or will include but are not limited to allergy skin testing and diagnostic imaging for a subset of the population. Blood samples were or will be collected for a subset of the population.

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Collected Dataset / SIC_No_underlying_medical_conditions_Clinical_assessment

SIC_No_underlying_medical_conditions_Clinical_assessment

Population

SIC – No underlying medical conditions

Data Collection Event

SIC - No underlying medical conditions - Clinical assessment

Files

Variables Classifications