Page 87 - pfizervax

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

• Record nonstudy vaccinations as described in Section 6.5.

• Record details of any of the prohibited medications specified in Section 6.5.1
received by the participant if required for his or her clinical care.

• Discuss contraceptive use as described in Section 10.4.

• Ask the participant to contact the site staff or investigator immediately if he or she
experiences any of the following from Day 1 to Day 7 after vaccination (where Day 1
is the day of vaccination) to determine if an unscheduled reactogenicity visit is
required:

• Fever ≥39.0°C (≥102.1°F).

• Redness or swelling at the injection site measuring greater than 10 cm
(>20 measuring device units).

• Severe pain at the injection site.

• Any severe systemic event.

• Ask the participant to contact the site staff or investigator if a medically attended
event (eg, doctor’s visit, emergency room visit) or hospitalization occurs.

• Ask the participant to contact the site staff or investigator (this could be via the
COVID-19 illness e-diary) immediately if he or she experiences any respiratory
symptoms as detailed in Section 8.13.

• Schedule an appointment for the participant to return for the next study visit.

• Remind the participant to bring the e-diary to the next visit.

• Complete the source documents.

• The investigator or an authorized designee completes the CRFs.

• The investigator or appropriately qualified designee reviews the reactogenicity e-
diary data online following vaccination to evaluate participant compliance and as part
of the ongoing safety review. Daily review is optimal during the active diary period.

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