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Indications
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Pfizer has a 175-year commitment to medical and pharmaceutical breakthroughs, including a long history of participation in research and development of vaccines for various diseases.
Respiratory Syncytial Virus Vaccine
(COVID-19 Vaccine, mRNA) 2025-2026 Formula
COVID-19 vaccines from BioNTech and Pfizer, which are based on BioNTech proprietary mRNA technology, were developed by both BioNTech and Pfizer.
Meningococcal Groups A, B, C, W, and Y Vaccine
Pneumococcal 20-valent Conjugate Vaccine
Tick-Borne Encephalitis Vaccine
Meningococcal Group B Vaccine
Vaccine Clinical Insights: Vaccine Hesitancy and How to Overcome It… Read more
Dr. Gary Marshall, author of The Vaccination Handbook for Physicians, Read more
The What to Expect (WTE) Guide to Well-Baby Visits and Immunizations… Read more
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Indications
COMIRNATY® (COVID-19 Vaccine, mRNA) is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
COMIRNATY is approved for use in individuals who are:
Indications
ABRYSVO is a vaccine indicated for:
Important Safety Information
Important Safety Information
Do not administer COMIRNATY® (COVID-19 Vaccine, mRNA) to individuals with known history of a severe allergic reaction (e.g., anaphylaxis) to any component of COMIRNATY or to individuals who had a severe allergic reaction (e.g., anaphylaxis) following a previous dose of a Pfizer-BioNTech COVID-19 vaccine.
Management of Acute Allergic Reactions
Appropriate medical treatment must be immediately available to manage potential anaphylactic reactions following administration of COMIRNATY.
Myocarditis and Pericarditis
Postmarketing data from use of authorized or approved mRNA COVID-19 vaccines, including COMIRNATY, have demonstrated increased risks of myocarditis and pericarditis, with onset of symptoms typically in the first week following vaccination. The observed risk has been highest in males 12 years through 24 years of age.
To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or https:/www.pfizersafetyreporting.com or VAERS at 1-800-822-7967 or https://vaers.hhs.gov
Please click for COMIRNATY Full Prescribing Information and Patient Information.
Important Safety Information
Patients should always ask their healthcare providers for medical advice about adverse events. You are encouraged to report negative side effects of vaccines to the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). Visit http://www.vaers.hhs.gov or call 1-800-822-7967.
Please see full Prescribing Information for PENBRAYA.
Do not administer Pfizer-BioNTech COVID-19 Vaccine to individuals with a history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Pfizer-BioNTech COVID-19 Vaccine or to individuals who had a severe allergic reaction (e.g., anaphylaxis) following a previous dose of a Pfizer-BioNTech COVID-19 vaccine.
Management of Acute Allergic Reactions
Appropriate medical treatment must be immediately available to manage potential anaphylactic reactions following administration of Pfizer-BioNTech COVID-19 Vaccine.
Monitor Pfizer-BioNTech COVID-19 Vaccine recipients for the occurrence of immediate adverse reactions according to the Centers for Disease Control and Prevention (CDC) guidelines (https://www.cdc.gov/vaccines/covid-19/clinical-considerations/managing-anaphylaxis.html).
Myocarditis and Pericarditis
Postmarketing data with authorized or approved mRNA COVID-19 vaccines demonstrate increased risks of myocarditis and pericarditis, particularly within the first week following vaccination. For the Pfizer BioNTech COVID-19 Vaccine, the observed risk is highest in males 12 through 17 years of age. Although some cases required intensive care support, available data from short-term follow-up suggest that most individuals have had resolution of symptoms with conservative management. Information is not yet available about potential long-term sequelae.
The CDC has published considerations related to myocarditis and pericarditis after vaccination, including for vaccination of individuals with a history of myocarditis or pericarditis (https://www.cdc.gov/vaccines/covid-19/clinical-considerations/myocarditis.html).
Syncope
Syncope (fainting) may occur in association with administration of injectable vaccines. Procedures should be in place to avoid injury from fainting.
Altered Immunocompetence
Immunocompromised persons, including individuals receiving immunosuppressive therapy, may have a diminished response to Pfizer-BioNTech COVID-19 Vaccine.
Limitation of Vaccine Effectiveness
Pfizer-BioNTech COVID-19 Vaccine may not protect all vaccine recipients.
Adverse Reactions
Solicited adverse reactions included:
6 months through 23 months of age: Injection site redness; swelling and tenderness; decreased appetite; drowsiness; fever; irritability.
2 through 11 years of age: Injection site pain; redness and swelling; chills; diarrhea; fatigue; fever; headache; new or worsened joint pain; new or worsened muscle pain; vomiting.
Vaccination providers must report all vaccine administration errors, all serious adverse events, cases of myocarditis, cases of pericarditis, cases of Multisystem Inflammatory Syndrome (MIS), and cases of COVID-19 that result in hospitalization or death following administration of Pfizer-BioNTech COVID-19 Vaccine (2024-2025 Formula) to the Vaccine Adverse Event Reporting System (VAERS) by submitting online at https://vaers.hhs.gov/reportevent.html. Vaccination providers administering COMIRNATY (COVID-19 Vaccine, mRNA) (2024-2025 Formula) under EUA must adhere to the same reporting requirements. For further assistance with reporting to VAERS call 1-800-822-7967. The reports should include the words “Pfizer-BioNTech COVID-19 Vaccine (2024-2025 Formula) EUA” in the description section of the report. To the extent feasible, report adverse events to Pfizer 1-800-438-1985 or provide a copy of the VAERS form to Pfizer https://www.pfizersafetyreporting.com/.
Please click for Pfizer-BioNTech COVID-19 Vaccine Vaccination Provider and Recipient and Caregiver EUA Fact Sheets.
Please see full Prescribing for TRUMENBA®.
TicoVac® should not be given to anyone with a severe allergic reaction (e.g. anaphylaxis) to any component of TicoVac®.
Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of TicoVac®.
TicoVac® may not protect all individuals against TBE.
Some individuals with altered immunocompetence may have a reduced response to TicoVac®.
TicoVac® contains albumin, a derivative of human blood, and based on effective donor screening and product manufacturing processes carries an extremely remote and theoretical risk for transmission of viral diseases and variant Creutzfeldt-Jakob disease (vCJD).
In clinical studies, the most common adverse reactions in subjects 1 through 15 years of age who received TicoVac® were local tenderness (18.1%), local pain (11.2%), headache (11.1%), fever (9.6%), and restlessness (9.1%).
In clinical studies, the most common adverse reactions in subjects 16 through 65 years of age who received TicoVac® were local tenderness (29.9%), local pain (13.2%), fatigue (6.6%), headache (6.3%), and muscle pain (5.1%).
Safety and effectiveness have not been established in pregnant women.
Patients should always ask their healthcare providers for medical advice about adverse events. You are encouraged to report negative side effects of vaccines to the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). Visit https://www.vaers.hhs.gov/or call 1-800-822-7967. Please see full prescribing information for TicoVac® here.
Prevnar 20® is a vaccine indicated for active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F in individuals 6 weeks of age and older
Prevnar 20® is a vaccine indicated for active immunization for the prevention of otitis media caused by S. pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F in individuals 6 weeks through 5 years of age
Prevnar 20® is a vaccine indicated for active immunization for the prevention of pneumonia caused by S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F in individuals 18 years of age and older
The indication for the prevention of pneumonia caused by S. pneumoniae serotypes 8, 10A, 11A, 12F, 15B, 22F, and 33F in individuals 18 years of age and older is approved under accelerated approval based on immune responses as measured by opsonophagocytic activity (OPA) assay. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
Do not administer Prevnar 20® to individuals with a severe allergic reaction (eg, anaphylaxis) to any component of Prevnar 20® or to diphtheria toxoid
Safety and immunogenicity data on Prevnar 20® are not available for individuals in immunocompromised groups, and vaccination should be considered on an individual basis. Based on experience with pneumococcal vaccines, individuals with altered immunocompetence may have reduced immune responses to Prevnar 20®
Apnea following intramuscular vaccination has been observed in some infants born prematurely. Vaccination of premature infants should be based on the infant’s medical status and the potential benefits and risks
In individuals 2, 4, 6, and 12 through 15 months of age vaccinated with a 4-dose schedule, the most commonly reported solicited adverse reactions (>10%) were irritability, pain at the injection site, drowsiness, decreased appetite, injection site redness, injection site swelling, and fever
In individuals 15 months through 17 years of age vaccinated with a single dose, the most commonly reported solicited adverse reactions (>10%) were irritability, pain at the injection site, drowsiness, fatigue and muscle pain, decreased appetite, injection site swelling, injection site redness, headache, and fever
In individuals 18 years of age and older, the most commonly reported solicited adverse reactions (>10%) were pain at the injection site, muscle pain, fatigue, headache, and arthralgia. Additionally, injection site swelling was also reported (>10%) in individuals 18 through 59 years of age
Patients should always ask their healthcare providers for medical advice about adverse events. You are encouraged to report negative side effects of vaccines to the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). Visit www.vaers.hhs.gov or call 1-800-822-7967.
Please click for Prevnar 20® full Prescribing Information.
To report an adverse event, please call 1-800-438-1985
Pfizer for Professionals 1-800-505-4426
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