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PREVNAR® 13 Patient Counseling Information (pneumococcal 13-valent conjugate vaccine - diphtheria CRM197 protein)

17 PATIENT COUNSELING INFORMATION

Prior to administration of this vaccine, inform the individual, parent, guardian, or other responsible adult of the following:

  • The potential benefits and risks of immunization with Prevnar 13 [see Warnings and Precautions (5) and Adverse Reactions (6)].
  • The importance of completing the immunization series unless contraindicated.
  • Any suspected adverse reactions should be reported to their healthcare professional.

Provide the Vaccine Information Statements, which are available free of charge at the Centers for Disease Control and Prevention (CDC) website (www.cdc.gov/vaccines).

This product's label may have been updated. For current full prescribing information, please visit www.pfizer.com.

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Resources

website
Prevnar 13 Website for Healthcare Professionals
 
website
Vaccine Recommendations of the Advisory Committee on Immunization Practices (ACIP)
 
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Report Adverse Event
Pfizer Safety

To report an adverse event related to Pfizer-BioNTech COVID-19 Vaccine (also known as COMIRNATY®, COVID-19 mRNA, Vaccine BNT162b2 or BNT162) or Pfizer COVID-19 Treatment (also known as PAXLOVID™ (nirmatrelvir tablets; ritonavir tablets)), and you are not part of a clinical trial* for this product, click the link below to submit your information:

Pfizer Safety Reporting Site

*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.

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FDA Medwatch
You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.