PEDIA Informed Consent Form Pfizer

COVID-19 PEDIATRIC VACCINATION 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
Name of Minor: October 28, 2021 Birthdate: Sex:
Address:
Name of Parent/Guardian: Relationship:
Contact Number: ID Type:
Vaccination Site: ID #:
Section 1: Information on the risks and benefits of the Despite the side effects, recent studies show that the
Pfizer-BioNTech COVID-19 vaccine COVID-19 vaccination with Pfizer-BioNTech benefits far
outweigh the risks.
The Pfizer-BioNTech COVID-19 vaccine may prevent the
person vaccinated from getting severe COVID-19 infection Section 2: Parent's/Guardian's Consent for Minor's
and hospitalization. The Philippine FDA has authorized the Vaccination
emergency use of the Pfizer-BioNTech COVID-19 vaccine
to prevent COVID-19 related morbidity and mortality in I confirm that I have been provided with and have read the
individuals 12 years of age and older under an Emergency Pfizer-BioNTech COVID-19 vaccine and Emergency Use
Use Authorization (EUA). It is administered as a 2-dose Authorization (EUA) Information Sheet and the same has
series, 3 weeks apart, into the muscle of the upper arm. been explained to me. The Philippine FDA has authorized
the use of the Pfizer-BioNTech COVID-19 vaccine under
Side effects that have been reported with the Pfizer- an EUA since the gathering of scientific evidence for the
BioNTech COVID-19 vaccine include injection site pain, approval of the said vaccine and any other COVID-19
redness, and swelling; tiredness; headache; muscle pain; vaccine is still ongoing.
chills; joint pain; fever; nausea; vomiting; diarrhea; feeling
unwell; and swollen lymph nodes. Some of these side I confirm that the minor has been screened for conditions
effects were slightly more frequent in adolescents aged 12 that may merit deferment or special precautions during
to 15 years old. There is a remote chance that the vaccine vaccination as indicated in the Health Screening
could cause temporary one-sided facial drooping and/or Questionnaire.
severe allergic reaction. Signs of a severe allergic reaction
can include difficulty breathing, swelling of the face and I have received sufficient information on the benefits and
throat, a fast heartbeat, and/or a bad rash all over the risks of COVID-19 vaccines and I understand the possible
body. A severe allergic reaction would usually occur within risks if the minor is not vaccinated.
a few minutes to one hour after getting a dose of the
Pfizer-BioNTech COVID-19 vaccine. For this reason, the I was provided an opportunity to ask questions, all of
vaccine provider may ask the recipient to stay at the which were adequately and clearly answered. I, therefore,
vaccination site for monitoring post-vaccination. voluntarily release the Government of the Philippines, the
vaccine manufacturer, their agents and employees, as well
The United States Center for Disease Control and as the hospital, the medical doctors and vaccinators, from
Prevention (US CDC) and its partners are actively all claims relating to the results of the use and
monitoring reports of myocarditis and pericarditis after administration of, or the ineffectiveness of the Pfizer-
COVID-19 vaccination. BioNTech COVID-19 vaccine.
Myocarditis is the inflammation of the heart muscle, and

pericarditis is the inflammation of the outer lining of the
heart. In both cases, the body’s immune system causes
inflammation in response to an infection or some other
triggers. Both myocarditis and pericarditis have the
following symptoms: chest pain, shortness of breath,
feelings of having a fast-beating, fluttering, or pounding of
the heart. Cases of myocarditis reported to the US
Vaccine Adverse Event Reporting System (VAERS) have
occurred after mRNA COVID-19 vaccination, especially in
male adolescents and young adults, more often after the
second dose usually within 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 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
October 28, 2021
I understand that while most side effects are minor and Section 3: Minor's Assent for Vaccination
resolve on their own, there is a small risk of severe
adverse reactions, such as, but not limited to allergies, I ACKNOWLEDGE THAT:
and that should prompt medical attention be needed,
referral to the nearest hospital shall be provided I am being asked to decide if I,
immediately by the Government of the Philippines. I have
been given contact information for follow up for any
,
symptoms which may be experienced after vaccination. 
(Minor’s Name)
I understand that by signing this Form, the minor has a
right to health benefit packages under the Philippine
Health Insurance Corporation (PhilHealth), in case he/she , want to be vaccinated with the Pfizer-BioNTech
suffers a severe and/or serious adverse event, which is 
found to be associated with the Pfizer-BioNTech COVID-
(Age)
19 vaccine or its administration. I understand that
the right to claim compensation is subject to the guidelines COVID-19 vaccine.
of PhilHealth.
I have understood the information about the Pfizer-
I authorize releasing all information needed for public BioNTech COVID-19 vaccine which will be vaccinated to
health purposes including reporting to applicable national me, and I confirm that I have understoodthe same.
vaccine registries, consistent with personal and health
information storage protocols of the Data Privacy Act of I asked several questions about the Pfizer-BioNTech
2012. COVID-19 vaccine and got answers to the same. I
understand that I can ask questions and raise concern
Nonetheless, I understand that despite such authorization about COVID-19 vaccination anytime.
and consent given by me to release all personal and
sensitive information for public health purposes, I remain I understand the risk of the administration of the vaccine
entitled to the rights afforded to a Data Subject under the including the outcomes (that while most side effects are
Data Privacy Act of 2012. minor and resolve on their own, there can be a risk for
adverse reactions in rare circumstances.)
I have reviewed the information on risks and benefits of
the Pfizer-BioNTech COVID-19 vaccine in Section 1 above I know that I can stop at any time in the process of
and understand its risks and benefits. In providing my vaccination without anyone reprimanding me. The
consent below, I confirm that I have the legal authority to attending physician will still take care of me.
give consent for the vaccination of the minor named above
with the Pfizer-BioNTech COVID-19 vaccine: I want to receive the COVID-19 vaccine at this time.
I hereby give consent to the vaccination of the minor (ln case the minor is not capable of giving assent due to neurological
comorbidities and moderate to severe intellectual impairment, the parent
named above with the Pfizer-BioNTech COVID-19 or the authorized parental substitute can sign on his/her behalf.)
vaccine. I affirm that I have understood and reviewed the
information included in Section 1 herein. (If this consent is 
not signed, dated and returned, the minor will not be
Signature over Printed Name of the Minor
vaccinated).

Signature over Printed Name of the Parent/Guardian

Date

If you choose not to get vaccinated, please list down the
Date reason/s:
If you choose not to have your child/ward vaccinated, please

list down the reason/s:
Reference:
1. Pfizer-BioNTech COVlD-19 Vaccine Consent Form for lndividuals 12-17 Years of Age.
Retrieved from: https://www.mass.gov/doc/ma-consent-form-for-indivi
duals-under-18-years-of-age-english-5122021/downl oad
2. US CDC. September 8, 2021. Myocarditis and Pericarditis After mRNA COVlD-19 Vaccination.
Retrieved from: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/myocarditis.html

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COVID-19 PEDIATRIC VACCINATION INFORMED

CONSENT FORM AND ASSENT FORM FOR PFIZER-

Name of Parent/Guardian: Relationship:

Contact Number: ID Type:

Vaccination Site: ID #:

Myocarditis is the inflammation of the heart muscle, and

If you choose not to have your child/ward vaccinated, please

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