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PF-07302048 (BNT162 RNA-Based COVID-19 Vaccines)
Protocol C4591001

10.3.3. Recording/Reporting and Follow-up of AEs and/or SAEs

AE and SAE Recording/Reporting

The table below summarizes the requirements for recording adverse events on the CRF and
for reporting serious adverse events on the Vaccine SAE Report Form to Pfizer Safety.
These requirements are delineated for 3 types of events: (1) SAEs; (2) nonserious adverse
events (AEs); and (3) exposure to the study intervention under study during pregnancy or
breastfeeding, and occupational exposure.

It should be noted that the Vaccine SAE Report Form for reporting of SAE information is
not the same as the AE page of the CRF. When the same data are collected, the forms must
be completed in a consistent manner. AEs should be recorded using concise medical
terminology and the same AE term should be used on both the CRF and the Vaccine SAE
Report Form for reporting of SAE information.

Safety Event Recorded on the CRF Reported on the Vaccine
SAE Report Form to
Pfizer Safety Within 24
Hours of Awareness

SAE All All
Nonserious AE All None
Exposure to the study All AEs/SAEs associated All (and EDP supplemental
intervention under study with exposure during form for EDP)
during pregnancy or pregnancy or breastfeeding Note: Include all SAEs
breastfeeding, and associated with exposure
occupational exposure during pregnancy or
Occupational exposure is not
recorded. breastfeeding. Include all
AEs/SAEs associated with
occupational exposure.

• When an AE/SAE occurs, it is the responsibility of the investigator to review all
documentation (eg, hospital progress notes, laboratory reports, and diagnostic
reports) related to the event.

• The investigator will then record all relevant AE/SAE information in the CRF.

• It is not acceptable for the investigator to send photocopies of the participant’s
medical records to Pfizer Safety in lieu of completion of the Vaccine SAE Report
Form/AE/SAE CRF page.

• There may be instances when copies of medical records for certain cases are
requested by Pfizer Safety. In this case, all participant identifiers, with the

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