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

• The PI or authorized designee determined it was not needed.

This telephone contact will be recorded in the participant’s source documentation and the
CRF.

If the participant is unable to attend the unscheduled visit, or the PI or authorized designee
determined it was not needed, any ongoing local reactions/systemic events must be assessed
at the next study visit.

During the unscheduled visit, the reactions should be assessed by the investigator or a
medically qualified member of the study staff such as a study physician or a study nurse, as
applicable to the investigator’s local practice, who will:

• Measure body temperature (°F/°C).

• Measure minimum and maximum diameters of redness (if present).

• Measure minimum and maximum diameters of swelling (if present).

• Assess injection site pain (if present) in accordance with the grades provided in
Section 8.2.2.2.

• Assess systemic events (if present) in accordance with the grades provided in
Section 8.2.2.3.

• Assess for other findings associated with the reaction and record on the AE page of
the CRF, if appropriate.

The investigator or an authorized designee will complete the unscheduled visit assessment
page of the CRF.

8.13. COVID-19 Surveillance (All Participants)

If a participant experiences any of the following (irrespective of perceived etiology or
clinical significance), he or she is instructed to contact the site immediately and, if
confirmed, participate in an in-person or telehealth visit as soon as possible, optimally within
3 days of symptom onset (and at the latest 4 days after symptom resolution). Note that:

• If new symptoms are reported within 4 days after resolution of all previous symptoms,
they will be considered as part of a single illness and a second illness visit is not required;

• Surveillance of potential COVID-19 symptoms should continue even if a participant has
a positive SARS-CoV-2 test earlier in the study.

During the 7 days following each vaccination, potential COVID-19 symptoms that overlap
with specific systemic events (ie, fever, chills, new or increased muscle pain, diarrhea,
vomiting) should not trigger a potential COVID-19 illness visit unless, in the investigator’s

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