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Human medicines European public assessment report (EPAR): Vaxzevria (previously COVID-19 Vaccine AstraZeneca), COVID-19 Vaccine (ChAdOx1-S [recombinant]), COVID-19 virus infection, Date of authorisation: 29/01/2021, Revision: 28, Status: Authorised

The most common side effects with Vaxzevria are usually mild or moderate and get better within a few days after vaccination. When compared with the first dose, side effects reported after the second dose are milder and reported less frequently. People receiving Vaxzevria may experience more than one side effect at the same time.

The most common side effects are tenderness, pain and bruising at the injection site, headache, tiredness, muscle pain, general feeling of being unwell, chills, fever, joint pain and nausea (feeling sick). They may affect more than 1 in 10 people.

Thrombocytopenia (low levels of blood platelets), vomiting, diarrhoea, pain in legs or arms, swelling and redness at the injection site, flu-like illness and asthenia (weakness) may affect up to 1 in 10 people. Lymphadenopathy (enlarged lymph nodes), decreased appetite, dizziness, sleepiness, lethargy (lack of energy), hyperhidrosis (excessive sweating), abdominal (belly) pain, muscle spasms, itching, rash and urticaria (itchy rash) may affect up to 1 in 100 people.

Weakness in muscles on one side of the face (facial paralysis or palsy) may affect up to 1 in 1,000 people.

Thrombosis (formation of blood clots in the blood vessels) in combination with thrombocytopenia (thrombosis with thrombocytopenia syndrome, TTS) and Guillain-Barré syndrome (a neurological disorder in which the body’s immune system damages nerve cells) may affect up to 1 in 10,000 people.

A very small number of cases of angioedema (rapid swelling under the skin), capillary leak syndrome (fluid leakage from small blood vessels causing tissue swelling and a drop in blood pressure) and transverse myelitis (a neurological condition characterised by an inflammation in the spinal cord) have occurred with Vaxzevria. A very small number of cases of immune thrombocytopenia (a condition in which the immune system mistakenly targets blood platelets, reducing their levels and affecting normal blood clotting) and cerebrovascular venous and sinus thrombosis (formation of blood clots in the vessels draining blood from the brain) have also occurred.

Allergic reactions have occurred in people receiving the vaccine, including some cases of severe allergic reactions (anaphylaxis). As for all vaccines, Vaxzevria should be given under close supervision with appropriate medical treatment available.

Vaxzevria must not be given to people who have had thrombosis with thrombocytopenia syndrome (TTS) after receiving the vaccine. Vaxzevria must also not be given to people who have previously had capillary leak syndrome.

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