Informal Request for ATI Records Previously Released

Organization: Health Canada

Year: 2024

Month: July

Request Number: A-2023-001135

Request Summary: SUMMARY MONTHLY SAFETY REPORT #4. The date when this report was received; the date when the review was completed and by whom; findings including: newly identified signals, both validated and invalidated, as identified during this reporting period and how it corresponds with Pfizer’s list of Adverse Events of Special interest in the 5.3.6 post-marketing document; potential risks of the vaccine; missing information at the writing of this report, and Health Canada's (HC’s) plans to address these gaps; conclusions made by HC after reviewing the report; the number of deaths during this reporting period; how this information changed HC’s Risk Management Plans, Pharmacovigilance Plans and benefit-risk profile.

Disposition: Disclosed in part

Number of pages: 360

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