This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PLGB 17901/0355.
Vaxzevria, suspension for injection, COVID 19 Vaccine (ChAdOx1 S [recombinant])
Vaxzevria® suspension for injection
COVID-19 Vaccine (ChAdOx1-S [recombinant])
▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.
1. What Vaxzevria is and what it is used for
2. What you need to know before you are given Vaxzevria
3. How Vaxzevria is given
4. Possible side effects
5. How to store Vaxzevria
6. Contents of the pack and other information
Vaxzevria is a vaccine used for preventing COVID-19, caused by a virus called coronavirus (SARS-CoV-2).
Vaxzevria is given to adults aged 18 years and older.
Vaxzevria stimulates the body’s natural defences (immune system). It causes the body to produce its own protection (antibodies) against the virus. This will help to protect you against COVID-19 in the future. None of the ingredients in this vaccine can cause COVID-19.
If you are not sure, talk to your doctor, pharmacist or nurse.
Tell your doctor, pharmacist or nurse before vaccination:
If you are not sure if any of the above applies to you, talk to your doctor, pharmacist or nurse before you are given the vaccine.
Extremely rare cases of blood clots with low levels of blood platelets (thrombosis with thrombocytopenia syndrome) have been observed following vaccination with Vaxzevria. This included some severe cases with blood clots in different or unusual locations and excessive clotting or bleeding throughout the body. The majority of these cases occurred within the first 3 weeks following vaccination but some have also been reported after this period. Some cases were life-threatening or had a fatal outcome. It is important to remember the benefits of vaccination to give protection against COVID-19 still outweigh any potential risks.
Blood clots in the brain, not associated with low level of blood platelets have been observed very rarely following vaccination with Vaxzevria. The majority of these cases occurred within the first four weeks following vaccination. Some cases had a fatal outcome.
Very low levels of blood platelets (immune thrombocytopenia), that can be associated with bleeding, have been reported very rarely, usually within the first four weeks following vaccination with Vaxzevria.
If you experience any of the following from around 4 days after vaccination you should seek medical advice urgently:
Tell your doctor, pharmacist or nurse if you experienced a blood clot occurring at the same time as low levels of platelets after receiving a previous dose of the vaccine.
Capillary leak syndrome
Very rare cases of capillary leak syndrome (CLS) have been reported following vaccination with Vaxzevria. Some affected patients had a previous diagnosis of CLS. CLS is a serious, potentially fatal condition causing fluid leakage from small blood vessels (capillaries) resulting in rapid swelling of the arms and legs, sudden weight gain and feeling faint (low blood pressure). Seek immediate medical attention if you develop these symptoms in the days following vaccination.
As with any vaccine, the 2-dose vaccination course of Vaxzevria may not fully protect all those who receive it. It is not yet known how long you will be protected for. No data are currently available in individuals with a weakened immune system or who are taking chronic treatment that suppresses or prevents immune responses.
Seek immediate medical attention if you develop weakness and paralysis in the extremities that are persistent and can affect both sides of the body at the same time and can progress to the chest and face (Guillain-Barré Syndrome). This has been reported very rarely after vaccination with Vaxzevria.
Extremely rare cases of acute disseminated encephalomyelitis (inflammation in the brain and spinal cord) have been reported following vaccination with Vaxzevria. However, it has not been determined whether these events were due to the vaccine. Seek urgent medical attention if you develop weakness, numbness or tingling in the extremities, changes to your state of awareness, alertness or wakefulness, changes to your eyesight, or seizures.
Vaxzevria is not recommended for children aged below 18 years. No data are currently available on the use of Vaxzevria in children and adolescents younger than 18 years of age.
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take, any other medicines or vaccines.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor, pharmacist or nurse for advice before you receive this vaccine.
Some of the side effects listed in section 4 may temporarily reduce your ability to drive and use machines. If you feel unwell after vaccination, do not drive or use machines. Wait until any effects of the vaccine have worn off before you drive or use machines.
This medicine contains less than 1 mmol sodium (23 mg) per dose of 0.5 ml. This means that it is essentially ‘sodium-free’.
This medicine contains a very small amount of alcohol (2 mg of alcohol (ethanol) per dose of 0.5 ml). This is not enough to cause any noticeable effects.
Vaxzevria is given as an injection of 0.5 ml into a muscle (usually in the upper arm).
You will receive 2 injections. You will be told when you need to return for your second injection of Vaxzevria.
The second injection can be given between 4 and 12 weeks after the first injection.
When Vaxzevria is given for the first injection, it is recommended that the second injection to complete the primary vaccination course should also be with Vaxzevria.
If you forget to go back at the scheduled time, ask your doctor, pharmacist or nurse for advice. It is important that you return for your second injection of Vaxzevria. If you miss a scheduled injection, you may not be fully protected against COVID-19.
You may receive a third (booster) injection of Vaxzevria. The booster injection may be given at least 3 months after you have completed the primary vaccination course with Vaxzevria.
Like all medicines, this vaccine can cause side effects, although not everybody gets them.
Get urgent medical attention if you get symptoms of a severe allergic reaction. Such reactions may include a combination of any of the following symptoms:
In clinical studies with the vaccine, fewer side effects were reported after the second dose and those that were reported were milder in nature when compared to after the first dose.
If side effects such as pain and/or fever are troublesome, medicines containing paracetamol can be taken.
Very common (may affect more than 1 in 10 people)
Common (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
Rare (may affect up to 1 in 1,000 people)
Very rare (may affect up to 1 in 10,000 people)
Not known (cannot be estimated from the available data)
In clinical trials there were very rare reports of events associated with inflammation of the nervous system, which may cause numbness, pins and needles, and/or loss of feeling. However, it is not confirmed whether these events were due to the vaccine.
* Some people have reported a sudden feeling of cold with shivering/shaking accompanied by a rise in temperature, possibly with sweating, headache (including migraine-like headaches), nausea, muscle aches and feeling unwell, starting within a day of having the vaccine and usually lasting for a day or two.
If your fever is high and lasts longer than two or three days, or you have other persistent symptoms, this might not be due to side effects of the vaccine and you should follow appropriate advice according to your symptoms.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
If you are concerned about a side-effect it can be reported directly via the Coronavirus Yellow Card reporting site https://coronavirus-yellowcard.mhra.gov.uk/ or search for MHRA Yellow Card in the Google Play or Apple App Store and include the vaccine brand and batch/Lot number if available.
By reporting side effects you can help provide more information on the safety of this vaccine.
Keep this medicine out of the sight and reach of children.
Your doctor, pharmacist or nurse is responsible for storing this vaccine and disposing of any unused product correctly.
Do not use Vaxzevria after the expiry date which is stated on the label after EXP.
Store in a refrigerator (2°C – 8°C).
Do not freeze.
Keep vials in outer carton to protect from light.
The vaccine does not contain any preservative and should be administered by a healthcare professional. After the first dose is withdrawn, the vaccine should be used as soon as practically possible and within 6 hours. During use it can be stored from 2°C to 25°C.
Vaxzevria contains genetically modified organisms (GMOs). Any unused vaccine or waste material should be disposed of in accordance with local requirements. Spills should be disinfected using agents with activity against adenovirus.
One dose (0.5 ml) contains:
COVID-19 Vaccine (ChAdOx1-S* recombinant), not less than 2.5 × 108 infectious units
*Recombinant, replication-deficient chimpanzee adenovirus vector encoding the SARS-CoV-2 Spike glycoprotein. Produced in genetically modified human embryonic kidney (HEK) 293 cells.
This product contains genetically modified organisms (GMOs).
The other excipients are L-histidine, L-histidine hydrochloride monohydrate, magnesium chloride hexahydrate, polysorbate 80 (E 433), sucrose, disodium edetate dihydrate, water for injections (see section 2 “Vaxzevria contains sodium and alcohol”).
Suspension for injection. The suspension is colourless to slightly brown, clear to slightly opaque.
Pack sizes (not all pack sizes may be marketed):
For any information about this medicine, please contact:
This leaflet was last revised in November 2023
VAXZEVRIA® is a registered trademark of the AstraZeneca group of companies.
INF 23 0046a
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Vaxzevria suspension for injection 17901/0355
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