Page 92 - pfizervax

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

• 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 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.

8.11.1.7. Visit 6 – 2-Week Follow-up Visit (Vaccination 2): (12 to 16 Days After Visit 4)
• Record AEs as described in Section 8.3.

• Review the participant’s reactogenicity e-diary data. Collect stop dates of any
reactogenicity e-diary events ongoing on the last day that the reactogenicity e-diary
was completed and record stop dates in the CRF if required.

• Review hematology and chemistry laboratory results and record any AEs in
accordance with Appendix 2.

• Measure vital signs (body temperature, pulse rate, and seated blood pressure), and, if
indicated by any change in the participant’s health since the previous visit, perform a
physical examination, evaluating any clinically significant abnormalities within the
following body systems: general appearance; skin; head, eyes, ears, nose, and throat;
heart; lungs; abdomen; musculoskeletal; extremities; neurological; and lymph nodes.

• Record nonstudy vaccinations as described in Section 6.5.

Page 82