Screening Questionnaire for Influenza HA Vaccine

For voluntary vaccination

This screening questionnaire cannot be used for routine vaccinations.
For routine vaccinations, the questionnaire provided by the municipal government should be used.
※ Please fill out information only within the ‘bolded’ frames if you wish to receive the vaccination.
Please circle the appropriate one of the two options in the answer columns.
※ If a child is to be vaccinated, a parent/guardian who is familiar with the child’s health condition
should fill out the questionnaire.

Body temperature beforeexamination

AddressTEL (Male・Female

Name of the recipient
Name in English (if needed)℃)-Day

Date ofbirthMonthYear/（Name of the guardian）/（Age:QuestionsyearsAnswer

Doctor’s Use

1. Have you read and understood the explanation about the flu shot (on theback) that you are about to receive today?

No

2. Do you have any concerns about your health condition today?

Yes, please specify ()3. Currently, are you under treatment by a doctor for any disease?
Has the doctor told you if it is OK to receive the vaccination today?

Yes, Name of disease (Yes/No/Haven’t talked in particular.

)

4. Have you been ill within the past month?

Yes, Name of disease ()No

Yes, Name of disease ()No)

No

5. Do you have any significant past medical history to declare (any congenital
anomaly, any disease of the heart, kidneys, liver or cranial nerves, anyimmunodeficiency, any blood dyscrasia, etc.)?
6. Have you ever experienced a skin rash/urticaria or felt ill after taking certain
medications or eating certain foods (especially, egg, poultry, other poultryderived foods)?

Yes

Yes

Name of medication(s)/foods (Yes (about

7. Have you ever suffered from convulsions?

NoNoepisode[s])（Date of the last episode:Around Month

8. Have you ever been diagnosed as having a respiratory disease(s), such as
interstitial pneumonia or bronchial asthma?

months）/Year）Yes

NoNo

9. Is the vaccine that you are about to receive today your first this season?

No, Date of the last vaccination(Day

10. Have you ever felt unwell after receiving a flu shot?

Yes

11. Have you ever felt unwell after receiving any vaccine other than a flushot?

Yes, Name of vaccine (/Month)

Yes
No

12. Have you received any vaccine within the past month?

Yes, Date of vaccination (Name of vaccine (13. Do you have any close relatives with congenital immunodeficiency?

Yes

14. Has anyone among your close relatives or other contacts been diagnosed
as having measles, rubella, varicella, mumps, etc., in the last month?

Yes

15. [Females only] Are you currently pregnant?

Yes

16. [If the person about to be vaccinated is a child]Were any abnormalities detected in the child during delivery, at birth, orduring infant checkups?
Birth weight ()gYesDayMonth/)No))

NoNo

Name of disease ()NoNo

Please specify ()No

17. Please specify any other concerns or questions you might have about yourhealth condition that you want to share with the doctor.
Doctor’s Comments
Based on the above information and results of medical examination, I believe that today's vaccine (can be administered/should be postponed).
I have explained to the recipient/guardian about the effects of the vaccination, the possible adverse reactions, and the relief services available tothe recipients for any adverse reactions, in accordance with the Pharmaceuticals and Medical Devices Agency Act.
Signature, or name and seal of the doctor

Patient/Guardian’s Use
I (agree/disagree) to be vaccinated, after having undergone a medical checkup by the doctor, as well as received and understood the doctor’s
explanation about the vaccination and its effects and possible adverse reactions.
Signature（if you are a proxy: relationship to the vaccine recipient

Name of vaccine to be used□Influenza HA Vaccine “KMB”
Lot No.:Medical record No.:
（Seller: Meiji Seika Pharma Co., Ltd.）

Dosage and Administration
Subcutaneous□0.5 mL（3 yrs. old and older）□0.25 mL（6 months to under 3 yrs. old））

Note if the recipient is unable to sign the form,a proxy should sign it and indicate his/her
relationship to the recipient.

Institution/Doctor’s name/Date and time of vaccination
Institution:
Doctor’s name:Date and time of vaccination:
Hours: minutes, Day

Your provided personal information will be used only for the screening examination performed prior to the influenza vaccination.

/Month/YearScreening Questionnaire for Influenza HA Vaccine

For voluntary vaccination

For influenza HA vaccination, the health condition of the recipient must be clearly known. Therefore, please
fill out the Screening Questionnaire on the front page as much in detail as possible. If a child needs to bevaccinated, a parent/guardian who is familiar with the health condition of the child should fill out the form.

Effects and Adverse Reactions of the Vaccine

Influenza HA vaccination is expected to prevent influenza or minimize the symptoms of influenza. It is also expected to prevent
complications of and death from influenza.
In general, adverse reactions to this vaccine are minor. The injection site may become red, swollen, hard, warm, painful, numb, orshow blisters, but these reactions usually resolve spontaneously within a few days. Fever, chills, headache, fatigue, transient loss ofconsciousness, dizziness, lymphadenopathy, cough, vomiting/nausea, abdominal pain, diarrhea, decreased appetite, joint pain,
myalgia, and/or muscular weakness may also occur. Hypersensitivity reactions such as rash, urticaria, eczema, erythema, erythemamultiforme, itching, and/or angioedema may also occur. Other possible reactions include cellulitis, paralysis such as facial nerve
paralysis, peripheral neuropathy, syncope, vasovagal reaction, uveitis, and tremor. People with strong egg allergies or other allergies
should notify their doctor prior to the vaccination because of the possibility of a strong hypersensitivity reaction(s). Significant
adverse reactions may include the following: (1) Shock, anaphylaxis (urticaria, dyspnea, angioedema, etc.), (2) acute disseminatedencephalomyelitis (fever, headache, convulsions, movement disorder, disturbed consciousness, etc., that appear within a few days to
two weeks after vaccination), (3) encephalitis/encephalopathy, myelitis, optic neuritis, (4) Guillain-Barre syndrome (numbness inboth hands and feet, gait disorder, etc.), (5) convulsions (including febrile convulsions), (6) hepatic function disorder, jaundice, (7)asthmatic attack, (8) thrombocytopenic purpura, thrombocytopenia, (9) vasculitis (IgA vasculitis, eosinophilic granulomatosis withpolyangiitis, leucocytoclastic vasculitis, etc.), (10) interstitial pneumonia, (11) oculomucocutaneous syndrome (Stevens-Johnsonsyndrome), acute generalized exanthematous pustulosis, (12) nephrotic syndrome (the frequency of any of these is unknown). If
other unknown or worrisome symptoms appear, or if any of the aforementioned diseases are suspected, please consult the doctor in
charge of the vaccination or your local medical institution.

Persons who are ineligible for the vaccination

A person:1) with obvious fever (37.5°C or higher)2) evidently suffering from a serious acute illness3) with a history of anaphylaxis (a severe allergic reaction with dyspnea, generalized urticaria, etc., that usually appears within 30
minutes after vaccination) upon receiving the influenza HA vaccine in the past
Note that any person with a history of developing an anaphylactic reaction after receiving another drug should inform his/her
doctor and seek the doctor’s judgment about the appropriateness of receiving the vaccination.
4) Other than those listed above whose doctor has determined that he/she is an inappropriate candidate to receive the vaccination

People who must consult a doctor before receiving vaccinations

A person:1) with a cardiac, renal, hepatic or vascular disease2) who is developmentally immature and under the care of a doctor or health nurse3) with a history of fever, rash, urticaria, or other allergic symptoms within 2 days of receiving a vaccination in the past4) with a history of skin rashes or other physical problems due to medications or foods (chicken eggs, poultry, etc.)
5) with a history of convulsions in the past6) with a history of having been diagnosed to have immunodeficiency, or having a close relative suffering from congenital
immunodeficiency
7) who may be pregnant8) with respiratory problems, such as interstitial pneumonia or bronchial asthma

Post-vaccination precautions

1) Acute adverse reactions (breathlessness, urticaria, cough, etc.) may occur within 30 minutes of receiving influenza HA vaccine.
Therefore, people should stay at the medical facility for a short while after receiving the vaccination to enable their condition to bemonitored, and be advised to contact the doctor immediately upon the emergence of any adverse reactions.
2) On the day of the vaccination, keep the injection site clean and go about your life as usual. Avoid strenuous exercise and heavy
drinking.
3) Bathing on the day of the vaccination is allowed, but rubbing the injection site should be avoided.
4) In the unlikely event of development of unusual symptoms such as high fever or convulsions, seek medical attention immediately.
Day

Scheduleddate ofvaccination

MonthDay of the week/()

Name ofInstitution

Please come to the reception deskat around (Hours:minutes) on the day of the vaccination.

With regard to voluntary vaccination with influenza HA vaccine, there is asystem providing relief services under the Pharmaceuticals and Medical
Devices Agency Act for persons or their family members with healthproblems related to adverse reactions developing despite proper use of thevaccine, that are sufficiently serious to necessitate hospitalization. For more
information, please visit the website of the Pharmaceuticals and Medical
Devices Agency. For inquiries, please contact us (contact details on theright).

Consultation Center for Relief Services, Pharmaceuticals and Medical
Devices Agency
Shin Kasumigaseki Building, Kasumigaseki 3-3-2, Chiyoda-ku, Tokyo
100-0013, Japan
Phone: 0120-149-931 (Toll free)
URL: https://www.pmda.go.jp/relief-services/adr-sufferers/0020.html

Meiji Seika Pharma Co., Ltd.

IF005001Ⓢ
Revision:2024.8