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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

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