Important Safety Information

COMIRNATY^® (COVID‑19 Vaccine, mRNA)

IMPORTANT SAFETY INFORMATION & INDICATION

• You should NOT receive COMIRNATY® (COVID‑19 Vaccine, mRNA) if you have had a severe allergic reaction to any ingredient of COMIRNATY or a previous dose of a Pfizer‑BioNTech COVID-19 vaccine
• There is a remote chance that COMIRNATY could cause a severe allergic reaction. A severe allergic reaction would usually occur within a few minutes to 1 hour after getting a dose of the vaccine. For this reason, your vaccination provider may ask you to stay at the place where you received the vaccine for monitoring after vaccination. If you or your pre-teen or teenager experience a severe allergic reaction, call 9-1-1 or go to the nearest hospital. Signs of a severe allergic reaction can include:
  • difficulty breathing, swelling of the face and throat, a fast heartbeat, a bad rash all over the body, dizziness and weakness
• Authorized or approved mRNA COVID‑19 vaccines show increased risks of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart), particularly within the first week following vaccination. For COMIRNATY, the observed risk is highest in males 12 through 17 years of age. Seek medical attention right away if you have any of the following symptoms after receiving the vaccine, particularly during the 2 weeks after receiving a dose of the vaccine:
  • chest pain
  • shortness of breath
  • feelings of having a fast-beating, fluttering, or pounding heart

Additional symptoms, particularly in children, may include:

• • Fainting
  • Unusual and persistent fatigue or lack of energy
  • Persistent vomiting
  • Persistent pain in the abdomen
  • Unusual and persistent cool, pale skin
• Fainting can happen after getting injectable vaccines including COMIRNATY. Your vaccination provider may ask you to sit or lie down for 15 minutes after receiving the vaccine
• People with weakened immune systems may have a reduced immune response to COMIRNATY
• COMIRNATY may not protect all vaccine recipients
• Tell your vaccination provider about all of your medical conditions, including if you:
  • have any allergies
  • have had myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining outside the heart)
  • have a fever
  • have a bleeding disorder or are on a blood thinner
  • are immunocompromised or are on a medicine that affects the immune system
  • are pregnant, plan to become pregnant, or are breastfeeding
  • have received another COVID‑19 vaccine
  • have ever fainted in association with an injection
• The most commonly reported adverse reactions (≥10%) after a dose of COMIRNATY were pain at the injection site (up to 90.5%), fatigue (up to 77.5%), headache (up to 75.5%), chills (up to 49.2%), muscle pain (up to 45.5%), joint pain (up to 27.5%), fever (up to 24.3%), injection site swelling (up to 11.8%), and injection site redness (up to 10.4%).

These may not be all the possible side effects of the vaccine. Call the vaccination provider or healthcare provider about bothersome side effects or side effects that do not go away.

You should always ask your healthcare providers for medical advice about adverse events. Report vaccine side effects to the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) Vaccine Adverse Event Reporting System (VAERS). The VAERS toll-free number is 1‐800‐822‐7967 or report online to www.vaers.hhs.gov/reportevent.html. You can also report side effects to Pfizer Inc. at www.pfizersafetyreporting.com or by calling 1-800-438-1985

Please click here for full Prescribing Information for COMIRNATY

INDICATION

COMIRNATY® (COVID‑19 Vaccine, mRNA) is a vaccine approved for active immunization to prevent coronavirus disease 2019 (COVID‑19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older.

Pfizer‑BioNTech COVID‑19 Vaccine (2023-2024 Formula)

IMPORTANT SAFETY INFORMATION & AUTHORIZED USE

• A person should NOT get Pfizer-BioNTech COVID‑19 Vaccine if they had a severe allergic reaction after a previous dose of any Pfizer‑BioNTech COVID‑19 vaccine or to any ingredients in these vaccines.
• There is a remote chance that the vaccine could cause a severe allergic reaction. A severe allergic reaction would usually occur within a few minutes to one hour after getting a dose of the vaccine. For this reason, the vaccination provider may ask you to stay at the place where you received the vaccine for monitoring after vaccination. If your child experiences a severe allergic reaction, call 9-1-1, or go to the nearest hospital. Signs of a severe allergic reaction can include:
  • difficulty breathing, swelling of the face and throat, a fast heartbeat, a bad rash all over the body, or dizziness and weakness
• Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) have occurred in some people who have received mRNA COVID‑19 vaccines. Myocarditis and pericarditis following Pfizer‑BioNTech COVID‑19 vaccines have occurred most commonly in adolescent males 12 through 17 years of age. In most of these individuals, symptoms began within a few days following vaccination. The chance of having this occur is very low. Seek medical attention right away if your child has any of the following symptoms after receiving the vaccine, particularly during the 2 weeks after receiving a dose of the vaccine:
  • Chest pain
  • Shortness of breath or difficulty breathing
  • Feelings of having a fast-beating, fluttering, or pounding heart

Additional symptoms, particularly in children, may include:

• • Fainting
  • Unusual and persistent irritability
  • Unusual and persistent poor feeding
  • Unusual and persistent fatigue or lack of energy
  • Persistent vomiting
  • Persistent pain in the abdomen
  • Unusual and persistent cool, pale skin
• Fainting can happen after getting injectable vaccines, including Pfizer‑BioNTech COVID‑19 Vaccine. For this reason, your vaccination provider may ask you to stay at the place where you received the vaccine for monitoring after vaccination
• People with weakened immune systems may have a reduced immune response to Pfizer-BioNTech COVID‑19 Vaccine
• The Pfizer‑BioNTech COVID‑19 Vaccine may not protect everyone
• Tell your vaccination provider about all of your medical conditions, including if you:
  • have any allergies
  • has had myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining outside the heart)
  • has a fever
  • has a bleeding disorder or are on a blood thinner
  • is immunocompromised or are on a medicine that affects the immune system
  • is pregnant or is breastfeeding
  • has received another COVID‑19 vaccine
  • has ever fainted in association with an injection
• Side effects that have been reported with Pfizer‑BioNTech COVID‑19 vaccines include:
  • Severe allergic reactions
  • Non-severe allergic reactions such as rash, itching, hives, or swelling of the face
  • Myocarditis (inflammation of the heart muscle)
  • Pericarditis (inflammation of the lining outside the heart)
  • Injection site pain/tenderness
  • Tiredness
  • Headache
  • Muscle pain
  • Arm pain
  • Fainting in association with injection of the vaccine
  • Chills
  • Joint pain
  • Fever
  • Injection site swelling
  • Injection site redness
  • Nausea
  • Feeling unwell
  • Swollen lymph nodes (lymphadenopathy)
  • Decreased appetite
  • Diarrhea
  • Vomiting
  • Dizziness
  • Irritability

These may not be all the possible side effects. Serious and unexpected side effects may occur. Call the vaccination provider or healthcare provider about bothersome side effects or side effects that do not go away.

Report vaccine side effects to the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) Vaccine Adverse Event Reporting System (VAERS). The VAERS toll-free number is 1-800-822-7967 or report online to www.vaers.hhs.gov/ reportevent.html. Please include “Pfizer‑BioNTech COVID‑19 Vaccine (2023-2024 Formula) EUA” in the first line of box #18 of the report form.

In addition, individuals can report side effects to Pfizer Inc. at www.pfizersafetyreporting.com or by calling 1-800-438-1985

Please click here for Pfizer‑BioNTech COVID‑19 Vaccine Healthcare Providers Fact Sheet and Vaccine Recipient and Caregiver EUA Fact Sheet

AUTHORIZED USE

Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula)* is FDA authorized under Emergency Use Authorization (EUA) to prevent coronavirus disease 2019 (COVID‑19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 6 months through 11 years of age.

Hereafter referred to as Pfizer-BioNTech COVID-19 Vaccine