Comirnaty covid-19 mrna vaccine

What COMIRNATY is and what it is used for

COMIRNATY is a vaccine used for preventing COVID-19 caused by SARS-CoV-2 virus. The vaccine causes the immune system (the body’s natural defences) to produce antibodies and blood cells that work against the virus, so giving protection against COVID-19.

As COMIRNATY does not contain the virus to produce immunity, it cannot give you COVID-19

What you need to know before you receive COMIRNATY

COMIRNATY should not be given

if you are allergic to the active substance or any of the other ingredients of this medicine

Warnings and precautions

Talk to your doctor, pharmacist or nurse before you are given the vaccine if:

you have ever had a severe allergic reaction or breathing problems after any other vaccine

injection or after you were given COMIRNATY in the past

• you have had myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining outside the heart).
• you are feeling nervous about the vaccination process or have ever fainted following any needle injection.
• you have a fever.
• you have a bleeding problem, you bruise easily or you use a medicine to prevent blood-clots.
• you have a weakened immune system, because of a disease such as HIV infection or a medicine such as corticosteroid that affects your immune system.
• you have received another COVID-19 vaccine.

There is a remote chance that COMIRNATY could cause a severe allergic reaction. A severe allergic reaction would usually occur within a few minutes to one hour after getting a dose of COMIRNATY. For this reason, your vaccination provider may ask you to stay at the place where you received your vaccine for monitoring after vaccination. Signs of a severe allergic reaction can include:

• Difficulty breathing
• Swelling of your face and throat
• A fast heartbeat
• A bad rash all over your body
• Dizziness and weakness

Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) have occurred in some people who have received COMIRNATY. In most of these people, symptoms began within a few days following receipt of the second dose of COMIRNATY. The risk of myocarditis and pericarditis seems lower in children ages 5 through <12 years compared with ages 12 to 17 years. The chance of having this occur is very low. You should avoid strenuous physical activity for two weeks after vaccination. You should seek medical attention right away if you have any of the following symptoms after receiving COMIRNATY:

• Chest pain
• Shortness of breath
• Feelings of having a fast-beating, fluttering, or pounding heart

As with any vaccine, COMIRNATY may not fully protect all those who receive it and it is not known how long you will be protected.

Children

COMIRNATY is not recommended for infants aged under 6 months.

Other medicines and COMIRNATY

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines or have recently received any other vaccine.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before you receive this vaccine.

No data are available yet regarding the use of variant-adapted COMIRNATY during pregnancy or breast-feeding.

Driving and using machines

Some of the effects of vaccination mentioned in section 4 (Possible side effects) may temporarily affect your ability to drive or use machines. Wait until these effects have worn off before you drive or use machines.