Study protocol: cohort event monitoring for safety signal detection after vaccination with COVID-19 vaccines in Iran

Table 1 The main variables which gathered in enrolment and follow up questionnaires

Participant Information	Reactogenicity (pre-vaccination)	Reactogenicity (post-vaccination)	Follow-up questionnaire
Study Site	Fever	Injection site Pain	Medical care
Subject ID	Body temperature	Pain Severity	Hospitalization
Subject Name	Nausea	Redness	Hospitalization date
phone number	Nausea severity	Redness size	Discharge date
Name of next kin	Malaise	Swelling	Hospitalization reason
Phone number of next kin	Malaise severity	Swelling size	Hospitalization diagnostics
Vaccine dose ID	Chills	Induration	Hospitalization report
Vaccination date	Chills severity	Induration size	Hospital ID
Vaccine brand	Headache	Bruise	COVID-19
Birth date	Headache severity	Bruise size	COVID-19-Test
Marital Status	Pain	Warmness	COVID-19 Symptom Onset Date
Sex	Pain severity	Warmness severity	ICU admission
Pregnancy	Muscle pain	Muscle pain	ICU admission Date
Lactation	Muscle pain Severity	Muscle pain Severity	Death
Chronic respiratory disease	Tired (fatigued)	Tired (fatigued)	Death date
Chronic heart disease	Tired Severity	Tired Severity	Reason of death
Chronic liver disease		Chills	Pregnancy
Chronic renal disease		Chills severity	Abortion
Diabetes		Headache	Menstrual irregularities
Immunocompromised / Immunosuppressed		Headache severity
Obesity		Fever
Allergy		Body temperature
Prior Covid		Nausea
Date of Prior Covid		Nausea severity
History of reaction to vaccination		Malaise
Weight		Malaise severity
Height

ISSN: 1471-2458