Pfizer-BioNTech COVID-19 Vaccine (5 Through 11 Years of Age)

Summary of Recent Changes and Updates

Webpage content and individual PDFs are updated when there’s new guidance concerning the Pfizer-BioNTech COVID-19 Vaccine. Expand each section below to see a summary of new and updated items.

General Pfizer-BioNTech Vaccine Information
Vaccine: Pfizer-BioNTech COVID-19 Vaccine
Administration Overview

Before administering vaccine, screen recipients for contraindications and precautions, even if the recipient is schedule to receive the second dose. The recipient’s health condition or recommendations regarding contraindications and precautions for vaccination may change from one visit to the next.

To assess recipients correctly and consistently, vaccination providers should use a standardized, comprehensive screening tool.

Contraindications and Precautions
How to Thaw, Prepare, and Administer the Pfizer-BioNTech Vaccine
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Document the Vaccination

COVID-19 vaccination providers must document vaccine administration in their medical record systems within 24 hours of administration and use their best efforts to report administration data to the relevant system for the jurisdiction (i.e., immunization information system) as soon as practicable and no later than 72 hours after administration.

Storage and Handling Overview
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Store vaccine in an ultra-cold freezer or refrigerator.
DO NOT STORE VACCINE IN FREEZER.
See guidance below for each storage unit.

  • Vaccine will arrive at a temperature between -90°C and -60°C (-130°F to -76°F) in a thermal shipping container with dry ice. The vial for children 5 through 11 years of age has an orange cap and orange border on the label.
  • Diluent and an ancillary supply kits will arrive separately from the vaccine
  • Follow the manufacturer’s guidance for unpacking the vaccine. (www.cvdvaccine-us.com/product-storage-and-dry-iceexternal icon).
  • Remove the temperature monitoring device from the shipping container and return using the included prelabeled foldable return box.
  • Dispose of the single-use thermal shipping container. Do NOT use the thermal shipping container for storage.*

*Thermal shipping containers delivered to Alaska, Hawaii, and the US-affiliated Pacific Islands may be used as temporary storage. Refer to the manufacturer for more detailed guidance on using the thermal shipping container for storage: https://www.cvdvaccine-us.com/product-storage-and-dry-iceexternal icon

How to Store the Pfizer-BioNTech COVID-19 Vaccine
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Report Adverse Events

Adverse events that occur in a recipient after COVID-19 vaccination are required to be reported to the Vaccine Adverse Event Reporting System (VAERS). FDA requires vaccination providers to report vaccine administration errors, serious adverse events, cases of multisystem inflammatory syndrome, and cases of COVID-19 that result in hospitalization or death after administration of COVID-19 vaccine under an EUA. Reporting is encouraged for other clinically significant adverse events, even if it is not clear that a vaccine caused the adverse event. Complete and submit reports to VAERS onlineexternal icon.

For further assistance with reporting to VAERS, call 1-800-822-7967.

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What to Expect after a COVID-19 Vaccination

Print informationpdf icon for your patients on common side effects, helpful tips, and when to call a doctor after a COVID-19 vaccination.

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Page last reviewed: November 17, 2021