Flucelvax Quadrivalent (Influenza) Consent Form  

Last Updated: Nov. 6th, 2023
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Description of Flucelvax Quadrivalent (Influenza Vaccine)    

FLUCELVAX QUADRIVALENT (Influenza Vaccine) is a subunit influenza vaccine manufactured using cell derived candidate vaccine viruses (CVV) that are propagated in Madin Darby Canine Kidney (MDCK) cells, a continuous cell line. These cells were adapted to grow freely in suspension in the culture medium. The virus is inactivated with β-propiolactone, disrupted by the detergent cetyltrimethylammonium bromide and purified through several process steps. Each of the 4 virus strains is produced and purified separately then pooled to formulate the quadrivalent vaccine.    

Note there are three vaccines that are generally favored for people over the age of 65. These include the Fluzone Highdose Quadrivalent vaccine, Flublok Quadrivalent recombinant flu vaccine, and the Fluad Quadrivalent adjuvanted flu vaccine. This recommendation comes from the Center for Disease Control (CDC), and is from a review of available studies that suggested in this age range, the vaccines are likely to have increased effectiveness than standard dose adjuvanted influenza vaccines. FLUCELVAX QUADRIVALENT may be insufficient for some individuals over the age of 65. It may not mount an adequate immune response, therefore has the potential to make an individual over the age of 65 vulnerable to severe illness. Although not preferentially recommended, the FLUCELVAX QUADRIVALENT vaccine is approved for use in persons 65 years of age or older. By signing below, you are acknowledging that the vaccine may not provide maximum protection against influenza.  

FLUCELVAX QUADRIVALENT is a sterile, slightly opalescent suspension in phosphate buffered saline. FLUCELVAX QUADRIVALENT is standardized according to United States Public Health Service requirements for the 2023-2024 influenza season and is formulated to contain a total of 60 micrograms (mcg) hemagglutinin (HA) per 0.5 mL dose in the recommended ratio of 15 mcg HA of each of the following four influenza strains:    

  • A/Georgia/12/2022 CVR-167 (an A/Wisconsin/67/2022 (H1N1)pdm09-like virus), A/Darwin/11/2021 (an A/Darwin/6/2021 (H3N2)-like virus), B/Singapore/WUH4618/2021 (a B/Austria/1359417/2021-like virus); B/Singapore/INFTT-16-0610/2016 (a B/Phuket/3073/2013-like virus).

  • Each dose of FLUCELVAX QUADRIVALENT may contain residual amounts of MDCK cell protein (≤ 25.2 mcg), protein other than HA (≤ 240 mcg), MDCK cell DNA (≤ 10 ng), polysorbate 80 (≤ 1500 mcg), cetyltrimethylammonium bromide (≤ 18 mcg), and β- propiolactone (< 0.5 mcg), which are used in the manufacturing process.    

  • FLUCELVAX QUADRIVALENT contains no egg protein or antibiotics.  

  • FLUCELVAX QUADRIVALENT 0.5 mL pre-filled syringes contain no preservative. 

  • FLUCELVAX QUADRIVALENT 5 mL multi-dose vials contain thimerosal, a mercury derivative, added as a preservative. Each 0.5 mL dose from the multi-dose vial contains 25 mcg mercury. 

  • The tip caps and plungers of the pre-filled syringes and the multi-dose vial stopper are not made with natural rubber latex.  

 

Contraindications  

History of severe allergic reactions (e.g., anaphylaxis) to any component of the vaccine.  

 

Adverse Reactions    

In children 6 months through 3 years of age who received FLUCELVAX QUADRIVALENT, the most commonly reported injection-site adverse reactions were tenderness (27.9%), erythema (25.8%), induration (17.3%) and ecchymosis (10.7%). The most common systemic adverse reactions were irritability (27.9%), sleepiness (26.9%), diarrhea (17.9%) and change of eating habits (17.4%).  

In children 2 through 8 years of age who received FLUCELVAX QUADRIVALENT, the most commonly reported injection-site adverse reactions were tenderness (28.7%), pain (27.9%) and erythema (21.3%), induration (14.9%) and ecchymosis (10.0%). The most common systemic adverse reactions were sleepiness (14.9%), headache (13.8%), fatigue (13.8%), irritability (13.8%) and loss of appetite (10.6%).    

In children and adolescents 9 through 17 years of age who received FLUCELVAX QUADRIVALENT, the most commonly reported injection-site adverse reactions were injection site pain (21.7%), erythema (17.2%) and induration (10.5%). The most common systemic adverse reactions were headache (18.1%) and fatigue (17.0%).  

In adults 18 through 64 years of age who received FLUCELVAX QUADRIVALENT, the most commonly reported injection-site adverse reactions were pain (45.4%), erythema (13.4%) and induration (11.6%). The most common systemic adverse reactions were headache (18.7%), fatigue (17.8%) and myalgia (15.4%). (6) • In adults ≥65 years of age who received FLUCELVAX QUADRIVALENT, the most commonly reported injection-site adverse reactions were pain (21.6%) and erythema (11.9%).  

 

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. 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.