Comirnaty (Covid-19 Vacine) Consent Form  

Last Updated: Nov. 17, 2023  

Description of Comirnaty (Covid-19 Vaccine)    

COMIRNATY (COVID-19 Vaccine, mRNA) is a sterile suspension for injection for intramuscular use.  

  • Each 0.3 mL dose of COMIRNATY (2023-2024 Formula) is formulated to contain 30 mcg of a nucleoside-modified messenger RNA (modRNA) encoding the viral spike (S) glycoprotein of SARS- CoV-2 Omicron variant lineage XBB.1.5 (Omicron XBB.1.5).  

  • Each 0.3 mL dose of COMIRNATY also includes the following ingredients: 

    • lipids (0.43 mg ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate) 

    • 0.05 mg 2-(polyethylene glycol 2000)-N,N-ditetradecylacetamide 

    • 0.09 mg 1,2-distearoyl-sn-glycero-3-phosphocholine 

    • .19 mg cholesterol) 

    • 0.06 mg tromethamine 

    • 0.4 mg tromethamine hydrochloride 

    • 31 mg sucrose. COMIRNATY does not contain preservatives.

  • The vial stoppers are not made with natural rubber latex. 

  • The prefilled syringe tip cap and plunger stopper are not made with natural rubber latex.

Dosage  

Regarding dosages for the COMIRNATY COVID-19 vaccine, note the following:  

Unvaccinated patients: 1 dose of an updated (2023–2024 Formula) mRNA COVID-19 vaccine (i.e., Moderna, Pfizer-BioNTech)  

Previously received 1 or more Original monovalent or bivalent mRNA vaccine doses: 1 dose of any updated (2023–2024 Formula) COVID-19 vaccine (i.e., Moderna, Novavax, Pfizer-BioNTech).  

Previously received 1 or more doses of Original monovalent Novavax vaccine, alone or in combination with any Original monovalent or bivalent mRNA vaccine doses: 1 dose of any updated (2023–2024 Formula) COVID-19 vaccine (i.e., Moderna, Novavax, Pfizer-BioNTech).  

Previously received 1 or more doses of Janssen vaccine, alone or in combination with any Original monovalent or bivalent mRNA vaccine or Original monovalent Novavax doses: 1 dose of any updated (2023–2024 Formula) COVID-19 vaccine (i.e., Moderna, Novavax, Pfizer-BioNTech). 
Note: People ages 65 years and older should only receive the recommended number of dose(s) of updated (2023–2024 Formula) mRNA or Novavax vaccine; an additional dose of COVID-19 vaccine is not recommended at this time. ACIP will continue to evaluate available data on the epidemiology of COVID- 19 and the safety and effectiveness of COVID-19 vaccines. Based on these assessments, ACIP will update COVID-19 vaccine policy and guidance as needed, especially for people at increased risk for severe COVID-19, including people ages 65 years and older.  

 

Contraindications  

Known history of a severe allergic reaction (e.g., anaphylaxis) to any component of COMIRNATY, that is listed in the description above.  

 

Warnings and Precautions  

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 COMIRNATY, the observed risk is highest in males 12 through 17 years of age.  

Syncope (fainting) may occur in association with administration of injectable vaccines, including COMIRNATY. Procedures should be in place to avoid injury from fainting.  

 

Adverse Reactions  

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%).  

*To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or VAERS at 1-800-822-7967 or http://vaers.hhs.gov.*  

 

Pre-Vaccination Telehealth Screening  

I consent to a telehealth screening appointment with a healthcare provider. A consultation is required prior to the vaccine to assure the safety and discuss any possible questions related to the vaccine.  

 

Post Vaccination On-Site Monitoring  

The post vaccination on-site monitoring pertains to all persons receiving a vaccine. This consists of remaining on the premises for 15 minutes after vaccination, so that staff may monitor you for any adverse reactions. This is recommended for the benefit of the patient, as with any vaccination there is always a rare risk or fainting or an allergic reaction. Note that an individual may refuse or leave early, so long as they understand we will be unable to monitor them.  

 

Consent for Services  

I have been presented with and read (or read to me) the Vaccine Information Statement(s), Vaccine Information Fact Sheet(s) and/or Patient Fact Sheet(s) relating to the vaccine(s). I acknowledge the risks and benefits of vaccination. I willingly assume full responsibility for any reactions or consequences that may result. I request the vaccine be administered to me (or the person named, whom I am authorized to make this request). In the event of any side effects, I understand I should contact the pharmacy, my doctor, or call 911. I certify that the information provided regarding eligibility for the vaccine is accurate. State of California only: I agree to have CAIR share my immunization data with Health Care Providers, schools or agencies.  

 

Authorization to Request Insurance  

I authorize Rume Health to release medical information to Medicaid, Medicare, or any other third party payer as required and to request payment of authorized benefits made on my behalf to Rume Health. I verify that the information given regarding my Medicaid, Medicare, or other coverages is accurate.  

 

Disclosure of Records  

I understand that Rume Health may be required to or voluntarily disclose my health information with regard to this vaccine to my healthcare providers, insurance plan, or other third party payer, hospitals, health systems, and/or federal or state registries. I understand that Rume Health will disclose and use my health information as set forth in the Rume Use and Disclosure of Health Information Document (copy available online or physical copy per request).  

By signing below, I am indicating my consent to the vaccination as indicated above. I have read through this entire consent form and have the had the opportunity to ask questions and get answers prior. I acknowledge my written/electronic signature is the legal equivalent of my manual signature of this agreement. If I am signing on behalf of another person (including a minor), I certify that I have the authority to do so.