Mpox vaccination clinical resources: Sample information sheets, consent forms, after care sheets

This page is currently under review. Some of the content may be out of date.

Consult the Canadian Immunization Guide for recommendations on smallpox and mpox vaccines.

Overview

Below are sample documents and forms that can be used in the immunization process. Provincial/territorial or local public health officials may have specific documents and forms for your jurisdiction.

Imvamune (smallpox/mpox) vaccine

Information sheet

Download in Word format the sample information sheet (104 Kb)

Please read this information sheet carefully and ensure all your questions have been answered by a health care provider before receiving the vaccine.

What is mpox?

Mpox is a viral disease that can be transmitted from animals to humans, from person-to person (including during sexual contact) or through direct contact with contaminated objects. Transmission can also occur from pregnant person to fetus. For more information on each mode of transmission, please consult this link: Mpox (monkeypox): Risks - Canada.ca.
Signs and symptoms of mpox can typically include lesions or sores on your skin, including in your mouth, genitals, or anal area, fever and swollen lymph nodes.
The number of lesions varies and you can be contagious from onset of first symptoms until scabs have fallen off and the skin is healed. This can take several weeks.
There are some antiviral medications that may help treat mpox and vaccines given before or soon after mpox exposure can help prevent infection.

How does the Imvamune vaccine protect against mpox?

Imvamune is a Modified Vaccinia Ankara (MVA) vaccine, manufactured by Bavarian Nordic. It was initially developed to be used for the prevention of smallpox, but its use has been expanded to help prevent mpox as well. When a person is given the vaccine, the immune system (the body's natural defense system) will produce its own protection in the form of antibodies against the smallpox and mpox viruses.
Recent studies have shown that one dose of mpox vaccine is almost 80% effective at preventing mpox at two or more weeks after vaccination. Two doses may result in higher protection. We don't yet know how long protection against mpox lasts.
The immunity from the vaccine takes about two weeks to build up after vaccination for your immune system to build up protective responses to mpox.

Who can and cannot receive the smallpox/mpox vaccine at this time?

The Imvamune vaccine is authorized for adults 18 years of age and older who do not have contraindications.
Although Imvamune is not authorized for children and has not been studied in this population, children may be at higher risk of severe outcomes from mpox infection and may benefit from vaccination. There is a lack of evidence of safety and protection from Imvamune in children but similar vaccines have not caused problems in this age group.

Table 1 indicates who should and should not receive the Imvamune vaccine and provides some questions you may be asked before being vaccinated and possible recommendations based on your response. These recommendations are based on the advice of the National Advisory Committee on Immunization (NACI).

Table 1: Questions and possible recommendations with regards to receiving the Imvamune vaccine
Questions	Possible recommendations
Are you feeling ill today?	If you have symptoms that could be mpox or another infectious disease, talk with your health care provider about your symptoms. Your health care provider will advise you when you are able to receive the vaccine.
Do you have or have you had an mpox infection?	Imvamune is not recommended for those who have had an mpox infection.
If you received a previous dose of Imvamune or another smallpox vaccine, did you have any side effects after vaccination (including allergic reactions or heart problems such as myocarditis/pericarditis)?	Individuals with suspected serious allergic reaction to the Imvamune vaccine may be able to safely receive a subsequent dose of the same vaccine under the supervision of an allergist. An individual who has a history of a mild, localized reaction to a prior dose of the Imvamune vaccine, or to any of its components, can safely receive the vaccine. You may be asked to wait in the clinic for 30 minutes after receiving the vaccine to make sure you are feeling well. For individuals with a history of myocarditis/pericarditis linked to a previous dose of smallpox vaccine and/or Imvamune, the benefit of protection against infection should be discussed with a healthcare provider. A precautionary approach is warranted at this time until more information is available.
Are you allergic to eggs or chicken products?^{Table 1 Footnote 1}	Although the Imvamune vaccine is grown in chicken egg cells, people with allergic reactions to eggs or chicken products can still receive the vaccine. You may be asked to wait in the clinic for 30 minutes after receiving the vaccine to make sure you are feeling well.
Are you known or suspected to be allergic to tromethamine (trometamol, Tris)^{Table 1 Footnote 2}, benzonase^{Table 1 Footnote 3}, gentamicin^{Table 1 Footnote 4} or ciprofloxacin^{Table 1 Footnote 4} which are contained in the Imvamune vaccine?	If you are known or suspected to be allergic to tromethamine (trometamol, Tris), benzonase, gentamicin or ciprofloxacin, you may receive the Imvamune vaccine. You may be asked to wait at the clinic for 30 minutes after receiving the vaccine to make sure you are feeling well.
Are you or could you be pregnant or breastfeeding?	People who are pregnant may particularly benefit from Imvamune as these people may be at risk for severe outcomes from mpox disease. There is a lack of evidence regarding the safety and effectiveness of Imvamune in people who are pregnant although at this time there is no reason to believe that vaccination would cause problems for the pregnant person or the fetus. People who are breastfeeding are not at higher risk for serious outcomes due to mpox infection. There is a lack of evidence regarding the safety and effectiveness of Imvamune in people who are breastfeeding, although at this time there is no reason to believe that vaccination would cause problems for the person who is breastfeeding or the baby.
Do you have any problems with your immune system or are you taking any medications that can affect your immune system (e.g., high dose steroids, chemotherapy, some arthritis medications)? Ask the health care provider if you are not sure about your medical conditions	The risk of severe disease from mpox can be higher in people with problems with their immune system, including people with human immunodeficiency virus (HIV), particularly if their HIV infection is not being appropriately treated. Although their response to the vaccine may be lower, it is important for people with problems with their immune system to be vaccinated. You should be sure to receive both doses of Imvamune 28 days apart.
Do you have atopic dermatitis (an allergic skin condition)?	Overall, Imvamune is well tolerated in people with atopic dermatitis although some side effects may come at higher frequency than in other people. Some may also experience a flare-up or a worsening of their atopic dermatitis.
Have you recently received specific medications for mpox treatment?	It is possible that some mpox treatments may affect the response to the vaccine. The mpox vaccine should not be given to people with known or suspected mpox.
Have you received another vaccine in the last 4 weeks or do you anticipate receiving another vaccine in the next 4 weeks?	Imvamune has not been specifically studied with other vaccines. In a high risk exposure scenario, Imvamune should not be delayed due to the receipt of a COVID-19 vaccine. If the Imvamune vaccine is planned, such as prior to employment at a research laboratory, as a precaution it is prudent to wait 4 weeks between Imvamune and a COVID-19 vaccine. In general, and as required, other vaccines can be given on the same day or anytime before or after Imvamune. Consult your health care provider if you recently received another vaccine.
Have you ever felt faint or fainted after a past vaccination or medical procedure?	If "yes", the health care provider may vaccinate you lying down to prevent you from fainting.
Table 1 Footnote 1 In Canada, there are several vaccines, including Imvamune, that are manufactured by processes involving hens' eggs or their derivatives, such as chick cell cultures. Return to table 1 footnote 1 referrer Table 1 Footnote 2 Tromethamine (trometamol, Tris) may very rarely cause allergic reactions and is found in some medications injected to do tests (contrast media) as well as other medications taken by mouth or injection, and some creams and lotions. Note that this is not a complete list. Return to table 1 footnote 2 referrer Table 1 Footnote 3 Benzonase is used for purification of viral vaccines, for manufacturing viral vectors for vaccine and for other applications in bioprocessing. Return to table 1 footnote 3 referrer Table 1 Footnote 4 Gentamicin and ciprofloxacin are antibiotics used in the treatment of some bacterial infections. Return to table 1 footnote 4 referrer

How is the vaccine administered?

The vaccine is usually administered into the fatty layer under the skin (subcutaneous tissue). This is usually in the back of the upper arm (triceps area) or in young children, in the outer part of the thigh (anterolateral thigh area). It can also be administered just under the skin (intradermally) forming a small bubble, usually on the inner surface of the forearm, but can also be in other locations.

What are the risks of the vaccine?

Imvamune vaccine has been authorized by Health Canada for active immunization against smallpox, mpox and related orthopoxvirus infection and disease under the provision of the Extraordinary Use New Drug (EUND) regulations in individuals determined to be at high risk for exposure. EUND vaccines continue to be monitored closely for clinical safety and effectiveness once they are in use by the public.
Imvamune does not contain smallpox or mpox virus and cannot spread or cause smallpox or mpox.
Side effects can develop within a few days after receiving the vaccine. Although most side effects are not serious to your health, they may make you feel unwell for a few days; they will go away on their own. Some common and expected side effects include one or more of the following:
- injection site reactions (for example, pain, redness, swelling and itching)
- tiredness
- headache
- muscle aches/pain
- chills
- nausea
Rarely allergic reactions can occur after receiving a vaccine. Symptoms of an allergic reaction include:
- difficulty breathing
- hives (bumps on the skin that are often very itchy)
- swelling of your face, tongue or throat
The clinic staff are prepared to manage an allergic reaction should it occur. Seek medical care immediately if you develop any of these symptoms.

What should you do before coming to the clinic?

Wear a short-sleeve shirt or top with sleeves that are easy to roll up.
To prevent feeling faint while being vaccinated, have something to eat before coming to the clinic.
Be sure to adhere to public health measures as advised with regards to preventing infections at the clinic.
Bring any identification required by the clinic, such as your health card and your immunization record.
If you suspect you have mpox, you should not come into contact with others or receive a vaccine. Consult a health care provider and/or public health official for advice. If mpox is ruled out, consult with a health care provider about when to receive your vaccine.

What should you do after receiving the vaccine?

You will be asked to wait at least 15 minutes after receiving the vaccine to be sure you are feeling well. Longer waiting times of 30 minutes may be recommended if there is concern about a possible vaccine allergy. Inform a health care provider right away if you feel unwell while waiting. You should not leave the clinic for at least 15 to 30 minutes after receiving your vaccine, based on the recommendation of the health care provider, and should not leave if you are feeling unwell.
Once you leave the clinic, call 9-1-1 right away if you develop any serious symptoms or symptoms of an allergic reaction such as hives (bumps on the skin that are often very itchy), swelling of your face, tongue or throat, or difficulty breathing.
Inform your health care provider or local public health services in your community of any concerning side effects after receiving the vaccine.
If you need to receive another type of vaccine in the four weeks after your Imvamune vaccine, be sure to mention to your immunizer that you received an Imvamune vaccine to determine whether the other vaccine should be administered.
If possible, wait at least two weeks after completing your Imvamune vaccination series before starting drugs that suppress your immune system, as recommended by your health care provider.
The immunity from the vaccine takes about two weeks to build up. Even when vaccinated, continue to follow safer sex practices (such as condom use and regular testing for sexually transmitted infections) which can help protect you and your partners from mpox and other sexually transmitted infections.
Keep your immunization record with information about the Imvamune vaccine in a safe place.

When should I return for my next dose of Imvamune?

Most people should receive a second dose of Imvamune at least 28 days after the first dose.
- Those who have previously been vaccinated against smallpox do not require a second dose as long as they have no problems with their immune system.
- Those who have problems with their immune system should be given a second dose 28 days after the first dose (regardless of whether they were previously vaccinated against smallpox before).

Bring your immunization record with you when you come for your next dose.

If you have any questions, please speak with the person providing the vaccine or contact: Insert contact information

Consent form

Download in Word format the sample consent form (100 Kb)

Imvamune vaccine has been authorized by Health Canada for active immunization against smallpox, mpox and related orthopoxvirus infection and disease under the provision of the Extraordinary Use New Drug (EUND) regulations in individuals determined to be at high risk for exposure. EUND vaccines continue to be monitored closely for clinical safety and effectiveness once they are in use by the public.

Last name:
First name:
Health card number / First Nations Status Card Number:
Phone number:
Email address:
Street address:
City:
Province:
Postal code:
Date of birth:
- Month
- Day
- Year
Age:
Gender/Sex: (insert options per data collection preferences)
How many doses of smallpox/mpox vaccine(s) have you had before?
- None
- One
- Two
If you have previously received a smallpox/mpox vaccine, specify the name and date of the previous smallpox/mpox vaccine(s) you have received, if known.
- Name of vaccine:
- Date: (month / day / year)
- Name of vaccine:
- Date: (month / day / year)
Are you feeling ill today?
- No
- Yes
- If yes, please provide details
Do you have or have you had an mpox infection?
- No
- Yes
- Uncertain
- If yes, please provide details including when the symptoms started, if known. If uncertain, please indicate what symptoms you have and when they started.
If you have had one or more previous smallpox or mpox vaccines, did you have any side effects after any previous dose(s) (including allergic reactions, or heart problems such as myocarditis/pericarditis)?
- No
- Yes
- If yes, please provide details
Are you allergic to eggs or chicken products?*
*In Canada, there are several vaccines, including Imvamune, that are manufactured by processes involving hens' eggs or their derivatives, such as chick cell cultures.
- No
- Yes
- If yes, please provide details
Are you known or suspected to be allergic to tromethamine (trometamol, Tris)**, benzonase***, gentamicin**** or ciprofloxacin**** which are contained in the vaccine?
**Tromethamine (trometamol, Tris) may very rarely cause allergic reactions and is found in some medications injected to do tests (contrast media) as well as other medications taken by mouth or injection, and some creams and lotions. Note that this is not a complete list.
***Benzonase is used for purification of viral vaccines, for manufacturing of viral vectors for vaccine and for other applications in bioprocessing.
****Gentamicin and ciprofloxacin are antibiotics used in the treatment of some bacterial infections.
- No
- Yes
- If yes, please provide details
Are you or could you be pregnant or are you breastfeeding?
- No
- Yes
- Uncertain
Do you have any problems with your immune system or are you taking any medications that can affect your immune system (e.g., high dose steroids, chemotherapy, some arthritis medications)?
Ask the health care provider if you are not sure about your medical conditions
- No
- Yes
- Uncertain
- If yes, please provide details
Do you have atopic dermatitis (an allergic skin condition)?
Ask the health care provider if you are not sure about your medical conditions
- No
- Yes
- Uncertain
- If yes, please provide details
Have you recently received specific medications for mpox treatment?
- No
- Yes
- If yes, please provide name of the medication and the date that you last took the medication
Have you received another vaccine in the last 4 weeks or do you anticipate receiving a vaccine in the next 4 weeks?
Ask your health care provider if you are not sure about vaccines you have received in the previous 4 weeks
- No
- Yes
- Uncertain
- If yes, please provide the type of vaccine and the date
Have you ever felt faint or fainted after a past vaccination or medical procedure?
- No
- Yes
- If yes, please provide details

I have read (or it has been read to me) and I understand the "Information sheet for Imvamune (smallpox/mpox) vaccine". I have had the opportunity to ask questions and to have them answered to my satisfaction. I consent to receiving the Imvamune vaccine.

Signature:
Print name:
Date of signature:
If signing for someone other than yourself, indicate your relationship to that other person:

I confirm that I am the parent / legal guardian or substitute decision maker.

For clinic use only
Vaccine	Dose/Route (0.5 mL/SC)	Lot number	Expiry date	Site and route	Time given	Date given month/day/year	Given by name and designation
Imvamune smallpox / mpox vaccine	-	-	-	-	-	-	-
Comments:

After care sheet

Download in Word format the sample after care sheet (88 Kb)

What should I do right after receiving the vaccine?

Wait for at least 15 minutes after receiving your vaccine. Longer waiting times of 30 minutes may be recommended if there is concern about a possible vaccine allergy. Though uncommon, fainting or allergic reactions can occur after vaccination. Symptoms of an allergic reaction include hives (bumps on the skin that are often very itchy), swelling of your face, tongue or throat, or difficulty breathing. The clinic staff are prepared to manage these events should they occur.
Immediately inform a health care provider at the clinic if you feel unwell while waiting. Do not leave the clinic if you are feeling unwell.
Do not operate a vehicle or other form of transportation for at least 15 to 30 minutes after being vaccinated (as advised by the health care provider) or if you are feeling unwell.
Follow all COVID-19 precautions while in the clinic, as recommended by the clinic staff.

What should I expect in the next few days?

Side effects can develop in the few days after receiving the vaccine. Although most of these side effects are not serious to your health, they may make you feel unwell for a few days. They will go away on their own.
- The most common side effect is pain where the needle was given; swelling, redness or itching may occur. A cool, damp cloth or wrapped ice pack where the vaccine was given may help.
- Other symptoms may include tiredness, headache, muscle aches/pain, chills and nausea.
- In individuals with atopic dermatitis (an allergic skin condition), it is possible that you may also experience a flare-up or a worsening of this condition.
- If needed, pain medication (such as acetaminophen) may help with pain. Check with your health care provider or local public health officials if you need advice about medication.
Serious side effects after receiving the vaccine are rare. However, should you develop any serious symptoms or symptoms that could be an allergic reaction, call 9-1-1 right away. Symptoms of an allergic reaction include:
- Difficulty breathing
- Hives (bumps on the skin that are often very itchy)
- Swelling of the face, tongue or throat
If you have any concerns about the symptoms you develop after receiving the vaccine, contact your health care provider or local public health officials for advice. Any serious side effects after vaccination should be reported to your local public health department.
If you need an additional dose of Imvamune vaccine, tell the person providing the next dose about any side effects you experienced.

When will I get the protective benefits from the vaccine?

The immunity from the vaccine takes about two weeks to build up. Even when vaccinated, continue to follow safer sex practices (such as condom use and regular testing for sexually transmitted infections) which can help protect you and your partners from mpox and other sexually transmitted infections.

When should I return for my next dose of vaccine?

Most people should receive a second dose of Imvamune at least 28 days after the first dose.
- Those who have previously been vaccinated against smallpox do not require a second dose as long as they have no problems with their immune system.
- Those who are have problems with their immune system should be given a second dose 28 days after the first dose (regardless of whether they were previously vaccinated against smallpox or mpox before).
Bring your immunization record with you for your next dose and tell the person providing the vaccine about any side effects you experienced after previous doses.

Things to remember

If you need to receive another type of vaccine in the four weeks after your Imvamune vaccine, be sure to mention to the health care provider that you received an Imvamune vaccine to determine whether the other vaccine should be administered.
If possible, wait at least two weeks after completing your vaccination series before starting drugs that suppress your immune system, as recommended by your health care provider.
The immunity from the vaccine takes about 2 weeks to build up. Even when vaccinated, continue to follow safer sex practices (such as condom use and regular testing for sexually transmitted infections) which can help protect you and your partners from mpox and other sexually transmitted infections.
Keep this sheet or other immunization record in a safe place.

Immunization record

Name of client:
Date of birth of client (month/day/year):
Health card number / First Nations Status Card Number:

Immunization record
Dose #	Date month/day/year	Vaccine Name and Dose	Lot number	Site right / left and route	Given by name and professional designation
1	-	-	-	-	-
2	-	-	-	-	-

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Date modified:: 2025-02-25

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