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Part C Confirmation format for serious adverse reactions

United Kingdom

Original text. Later amendments are not shown.

Reporting establishment

Report identification

Confirmation date (year/month/day)

Date of serious adverse reaction (year/month/day)

Confirmation of serious adverse reaction (Yes/No)

Imputability level (NA, 0-3)

Change of type of serious adverse reaction (Yes/No)

If Yes, specify

Clinical outcome (if known)

  • Complete recovery

  • Minor sequelae

  • Serious sequelae

  • Death