COVID-19 PEDIATRIC VACCINATION (5-11 YEARS OLD) INFORMED CONSENT FORM AND ASSENT FORM
FOR PFIZER-BIONTECH COVID-19 VACCINE of the Philippine National COVID-19 Vaccine Deployment and Vaccination Program as of January 21, 2022
I understand that while most side effects are minor and
resolve on their own, there is a small risk of severe adverse I understand that while most side effects are minor and reactions, such as, but not limited to allergies, and that resolve on their own, there is a small risk of severe should prompt medical attention be needed, referral to the adverse reactions, such as, but not limited to allergies, nearest hospital shall be provided immediately by the and that should prompt medical attention be needed, Government of the Philippines. I have been given contact referral to the nearest hospital shall be provided information for follow up for any symptoms which may be immediately by the Government of the Philippines. I have experienced after vaccination. been given contact information for follow up for any symptoms which may be experienced after vaccination. Section 1: Information on the risks and benefits of the Despite the side effects, recent studies show that Pfizer-BioNTech COVID-19 vaccine the COVID-19 vaccination with Pfizer-BioNTech I understand that by signing this Form, the minor has a right benefits far outweigh the risks. to health benefit packages under the Philippine Health I understand that by signing this Form, the minor has a Insurance Corporation (PhilHealth), in case he/she suffers a right to health benefit packages under the Philippine The Pfizer-BioNTech COVID-19 vaccine may prevent Health Insurance Corporation (PhilHealth), in case he/she the person vaccinated from getting severe COVID-19 Section 2: Parent’s/Guardian’s Consent for Minor’s severe and/or serious adverse event, which is found to be associated with the Pfizer-BioNTech COVID-19 vaccine or its suffers a severe and/or serious adverse event, which is infection and hospitalization. The Philippine FDA has Vaccination found to be associated with the Pfizer-BioNTech COVID-19 authorized the emergency use of the Pfizer-BioNTech administration. I understand that the right to claim compensation is subject to the guidelines of PhilHealth. vaccine or its administration. I understand that the right COVID-19 vaccine to prevent COVID-19 related I confirm that I have been provided with and have to claim compensation is subject to the guidelines of morbidity and mortality in individuals five years of age read the Pfizer-BioNTech COVID-19 vaccine and PhilHealth. and older under an Emergency Use Authorization Emergency Use Authorization (EUA) Information I authorize releasing all information needed for public health (EUA). It is administered as a 2-dose series, 3 weeks Sheet and the same has been explained to me. The purposes including reporting to applicable national vaccine registries, consistent with personal and health information I authorize releasing all information needed for public apart, into the muscle of the upper arm. Philippine FDA has authorized the use of the Pfizer- storage protocols of the Data Privacy Act of 2012. health purposes including reporting to applicable national BioNTech COVID-19 vaccine under an EUA since the vaccine registries, consistent with personal and health Side effects that have been reported with the Pfizer- gathering of scientific evidence for the approval of information storage protocols of the Data Privacy Act of BioNTech COVID-19 vaccine include injection site pain, the said vaccine and any other COVID-19 vaccine is Nonetheless, I understand that despite such authorization 2012. redness, and swelling; tiredness; headache; muscle still ongoing. and consent given by me to release all personal and pain; chills; joint pain; fever; nausea; vomiting; sensitive information for public health purposes, I remain entitled to the rights afforded to a Data Subject under the Nonetheless, I understand that despite such authorization diarrhea; feeling unwell; and swollen lymph nodes. I confirm that the minor has been screened for Data Privacy Act of 2012. and consent given by me to release all personal and Some of these side effects were slightly more frequent conditions that may merit deferment or special sensitive information for public health purposes, I remain in adolescents aged 12 to 15 years old. There is a precautions during vaccination as indicated in the entitled to the rights afforded to a Data Subject under the remote chance that the vaccine could cause temporary Health Screening Questionnaire. I have reviewed the information on risks and benefits of the Data Privacy Act of 2012. one-sided facial drooping and/or severe allergic Pfizer-BioNTech COVID-19 vaccine in Section 1 above and reaction. Signs of a severe allergic reaction can include I have received sufficient information on the understand its risks and benefits. In providing my consent below, I confirm that I have the legal authority to give I have reviewed the information on risks and benefits of difficulty breathing, swelling of the face and throat, a benefits and risks of COVID-19 vaccines and I the Pfizer-BioNTech COVID-19 vaccine in Section 1 above fast heartbeat, and/or a bad rash all over the body. A understand the possible risks if the minor is not consent for the vaccination of the minor named above with the Pfizer-BioNTech COVID-19 vaccine: and understand its risks and benefits. In providing my severe allergic reaction would usually occur within a vaccinated. consent below, I confirm that I have the legal authority to few minutes to one hour after getting a dose of the give consent for the vaccination of the minor named Pfizer-BioNTech COVID-19 vaccine. For this reason, the I was provided an opportunity to ask questions, all I hereby give consent to the vaccination of the minor named above with the Pfizer-BioNTech COVID-19 vaccine: vaccine provider may ask the recipient to stay at the of which were adequately and clearly answered. I, above with the Pfizer-BioNTech COVID-19 vaccine. I affirm vaccination site for monitoring post-vaccination. therefore, voluntarily release the Government of that I have understood and reviewed the information included in Section 1 herein. (If this consent is not signed, I hereby give consent to the vaccination of the minor the Philippines, the vaccine manufacturer, their named above with the Pfizer-BioNTech COVID-19 vaccine. The United States Center for Disease Control and agents and employees, as well as the hospital, the dated and returned, the minor will not be vaccinated). I affirm that I have understood and reviewed the Prevention (US CDC) and its partners are actively medical doctors and vaccinators, from all claims information included in Section 1 herein. (If this consent is monitoring reports of myocarditis and pericarditis after relating to the results of the use and administration not signed, dated and returned, the minor will not be COVID-19 vaccination. of, or the ineffectiveness of the Pfizer-BioNTech vaccinated). COVID-19 vaccine. Signature over Printed Name of the Parent/Guardian Myocarditis is the inflammation of the heart muscle, and pericarditis is the inflammation of the outer lining I understand that while most side effects are of the heart. In both cases, the body’s immune system minor and resolve on their own, there is a small causes inflammation in response to an infection or risk of severe adverse reactions, such as, but not Signature over Printed Name of the Parent/Guardian some other triggers. Both myocarditis and pericarditis limited to allergies, and that should prompt Date have the following symptoms: chest pain, shortness of medical attention be needed, referral to the breath, feelings of having a fast-beating, fluttering, or nearest hospital shall be provided immediately by pounding of the heart. Cases of myocarditis reported the Government of the Philippines. I have been If you choose not to have your child/ward vaccinated, please to the US Vaccine Adverse Event Reporting System given contact information for follow up for any list down the reason/s: Date (VAERS) have occurred after mRNA COVID-19 symptoms which may be experienced after vaccination, especially in male adolescents and young vaccination. ______________________________________________ If you choose not to have your child/ward vaccinated, adults, more often after the second dose usually within please list down the reason/s: several days after vaccination. Most patients with myocarditis or pericarditis who received care ______________________________________________ responded well to medicine and rest and felt better quickly. COVID-19 PEDIATRIC VACCINATION (5-11 YEARS OLD) INFORMED CONSENT FORM AND ASSENT FORM FOR PFIZER-BIONTECH COVID-19 VACCINE of the Philippine National COVID-19 Vaccine Deployment and Vaccination Program as of January 21, 2022
COVID-19 PEDIATRIC VACCINATION (5-11 YEARS OLD) HEALTH
ASSESSMENT ALGORITHM FOR PFIZER of the Philippine National COVID-19 Vaccine Deployment and Vaccination Program as of January 21, 2022 COVID-19 PEDIATRIC VACCINATION (5-11 YEARS OLD) INFORMED CONSENT FORM AND ASSENT FORM FOR PFIZER-BIONTECH COVID-19 VACCINE of the Philippine National COVID-19 Vaccine Deployment and Vaccination Program as of January 21, 2022 COVID-19 PEDIATRIC VACCINATION (5-11 YEARS OLD) INFORMED CONSENT FORM AND ASSENT FORM FOR PFIZER-BIONTECH COVID-19 VACCINE of the Philippine National COVID-19 Vaccine Deployment and Vaccination Program as of January 21, 2022