Vaccine AE

Consistency Between Tables Check

Introduction

Vaccine Adverse Events (AEs) are crucial considerations in vaccine studies, often documented in three distinct categories: adverse events, local reactions (such as redness, swelling, pain in injection site, limitation of arm movement, and any local reaction), and systemic events (including fever, fatigue, headache, vomiting, diarrhea, muscle pain, joint pain, and use of antipyretic or pain medication).

Purpose

Validate that the number of reported cases of AEs and the number of subjects affected by AEs align consistently throughout the study's tables.

Applicability 

Inclusion conditions 

• Vaccine studies
• Tables listing Vaccine AE, both in the title and within the table 
• Applicable tables are found by keywords:
  • ‘Local’
  • ‘Systemic’

Exclusion 

• Not applicable to empty tables.
• Figure, Listing, LoT, Mock Shell

Discrepancies

• A table that contains information about vaccine AE but doesn’t match to another table.

Discrepancy Example

Table 1:

Table 2: