Cohort Event Monitoring of safety of COVID-19 vaccines in special populations (pregnant and lactating women, children and adolescents, immunocompromised, people with history of allergy, people with prior SARS-CoV-2 infection) (Covid-Vaccine-Monitor CVM)

Data sources

• Data source(s), other:
  Safety data can be directly reported by vaccine recipients in their local language using the Lareb Intensive Monitoring (LIM) web app or the ResearchOnline web app, which have been both built specifically for patient-reported outcomes using exactly the same structure. As regards pregnancy monitoring, only ResearchOnline will be used as collecting additionally information on pregnancy. Collected data from European countries using LIM/ResearchOnline web app can be stored in dedicated central databases.
• Data sources (types):
  Administrative data (e.g. claims)

  Electronic healthcare records (EHR)

Use of a Common Data Model (CDM)

• CDM mapping:
  No

Data quality specifications

• Check conformance:
  Unknown
• Check completeness:
  Unknown
• Check stability:
  Unknown
• Check logical consistency:
  Unknown

Data characterisation

• Data characterisation conducted:
  No