Consent Information
By reading below and signing name, I, the undersigned patient (or authorized representative/legal guardian) consent to the performance of an examination and administration of the COVID-19 vaccine, as ordered or approved by Head 2 Toe Pediatrics, PLLC and I acknowledge and consent to the following:
1. I understand that COVID-19 Vaccines have been approved or authorized for emergency use by FDA, under an EUA to prevent Coronavirus Disease 2019 (COVID-19). The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner. COMIRNATY (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19 vaccine made by Pfizer for BioNTech.
2. I understand that it is not possible to predict all possible side effects or complications associated with receiving vaccine(s). I understand the risks and benefits associated with the above vaccine and have received, read and/or had explained to me the Emergency Use Authorization Fact Sheet on the COVID-19 vaccine I have elected to receive. I also acknowledge that I have had a chance to ask questions and that such questions were answered to my satisfaction.
3. I acknowledge that I have been advised to remain near the vaccination location for approximately 15 minutes (or more in specific cases) after administration for observation. If I experience a severe reaction, I will call 9-1-1 or go to the nearest hospital.
4. I hereby expressly authorize the Practice and all healthcare professionals providing care to release all necessary information to third party which may be responsible for paying for the Patient’s care. I authorize and direct all payors to pay all benefits due for such care directly to the Practice and all professionals providing for such care, and I hereby assign such sums to them. I understand this authorization and assignments shall remain valid unless I provide written notice of revocation to the Practice and the third-party payor signed and dated by me; however, such revocation shall not be effective as to information released and/or charges incurred prior to such revocation. I understand that any payment for which I am financially responsible is due at the time of service or if Head 2 Toe Pediatrics, PLLC invoices me after the time of service, upon receipt of such invoice.
5. The Department of Health and Human Services has established a “privacy rule” or “HIPAA”, to help ensure that personal health information (“PHI”) is protected and secure. I authorize the Practice to use or disclose my PHI for purposes of treatment, payment, and health care operations. I understand I have the right to refuse such use and disclosure upon a written request, and the Practice may accept or reject my request. Actions that have already been taken reliance on this signed form, or a previously signed consent, cannot be revoked. If you have any objections to this paragraph, please ask to speak to the Practice’s privacy officer.
6. I acknowledge that: (a) I understand the purposes/benefits of Florida SHOTS, Florida’s immunization registry and (b) Head 2 Toe Pediatrics, PLLC through Vaxcare will include my personal immunization information in Florida SHOTS and my personal immunization information will be shared with the Centers for Disease Control (CDC) or other federal agencies.
7. I understand that the healthcare professionals involved in my care will rely on my documented medical history, as well as other information provided by me, my immediate family, or others having information about me, in determining whether to perform or recommend procedures. I agree to provide accurate and thorough information regarding my medical history and any conditions or events which may impact medical decision-making.
8. I understand that during the course of my care various types of examinations, tests, and/or diagnostic procedures (“procedures”) may be necessary. These procedures may be performed by physician(s), nurses, technicians, nurse practitioners, or other healthcare professionals. While routinely performed without incident, there may be material risks associated with these procedures, such as irritation, discomfort/pain, nose bleed, sneezing, watery eyes, bleeding. If I have any questions concerning these procedures, I will ask my physician(s) to provide me with additional information. I also understand my physician may ask me to sign additional Informed Consent documents relating to specific procedures.
9. On behalf of myself, my heirs and personal representatives, I hereby release and hold harmless Head 2 Toe Pediatrics, PLLC and their staff, agents, successors, divisions, affiliates, subsidiaries, officers, directors, contractors and employees from any and all liabilities or claims whether known or unknown arising out of, in connection with, or in any way related to the administration of the vaccine received today.
10. I acknowledge I have received a copy of the Practice’s Notice of Privacy Practices as well as a copy of the Practice’s Patient Bill of Rights and Responsibilities.
