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PF-07302048 (BNT162 RNA-Based COVID-19 Vaccines)
Protocol C4591001
10.3.4. Reporting of SAEs
SAE Reporting to Pfizer Safety via Vaccine SAE Report Form
• Facsimile transmission of the Vaccine SAE Report Form is the preferred method to
transmit this information to Pfizer Safety.
• In circumstances when the facsimile is not working, notification by telephone is
acceptable with a copy of the Vaccine SAE Report Form sent by overnight mail or
courier service.
• Initial notification via telephone does not replace the need for the investigator to
complete and sign the Vaccine SAE Report Form pages within the designated
reporting time frames.
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