Details for: VAXZEVRIA - PREVIOUSLY/AUPARAVANT - ASTRAZENECA COVID-19 VACCINE

Like all medicines, VAXZEVRIA can cause side effects, although not everybody gets them.

Most side effects are mild to moderate in nature and resolve within a few days. Fewer side effects were reported after the second dose.

Side effects that have been reported with VAXZEVRIA were as follows:

Very Common (may affect more than 1 in 10 people)

• tenderness, pain, warmth, or itching where the injection is given
• generally feeling unwell
• feeling tired (fatigue)
• chills or feeling feverish
• headache
• feeling sick (nausea)
• joint pain or muscle ache

Common (may affect up to 1 in 10 people)

• swelling or redness where the injection is given
• fever
• being sick (vomiting) or diarrhea
• pain in legs or arms
• flu-like symptoms, such as high temperature, sore throat, runny nose, cough and chills

Uncommon (may affect up to 1 in 100 people)

• sleepiness or feeling dizzy
• decreased appetite
• abdominal pain
• enlarged lymph nodes
• excessive sweating, itchy skin, rash or hives
• sensation like numbness, tingling, pins and needles (paraesthesia)
• reduced sensation of touch (hypoaesthesia)
• ringing in the ears (tinnitus)

Severe allergic reaction (anaphylaxis), severe swelling of the lips, mouth, throat (which may cause difficulty in swallowing or breathing) have been reported following VAXZEVRIA. Should you develop any serious symptoms or symptoms that could be an allergic reaction, seek medical attention right away. Symptoms of an allergic reaction include:

• hives (bumps on the skin that are often very itchy)
• feeling faint or light-headed
• changes in your heartbeat
• swelling of your face, lips, tongue or throat
• difficulty breathing, shortness of breath or wheezing

Inflammation of blood vessels in the skin, often with a rash and small red or purple spots (cutaneous vasculitis) has been reported with unknown frequency.

A combination of major blood clots and low level of platelets, in some cases together with bleeding, has been observed very rarely following vaccination with VAXZEVRIA in post-authorization use. The majority of the cases occurred within the first 3 weeks following vaccination and some cases had a fatal outcome.

Blood clots in the brain, not associated with low levels 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 also been reported very rarely, usually within the first four weeks following vaccination with VAXZEVRIA. Seek medical attention right away if any of the following symptoms occur within the first month following vaccination:

• new severe headaches, worsening or persistent headaches, blurred vision, confusion or seizures
• shortness of breath, chest pain, leg swelling, leg pain or persistent abdominal pain
• unusual skin bruising or pinpoint round spots beyond the site of vaccination
• unexplained bleeding

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 medical attention right away if you develop these symptoms in the days following vaccination.

Guillain-Barré syndrome (GBS) is a neurological disorder where inflammation of peripheral nerves causes rapid muscle weakness and can sometimes lead to paralysis. This has been reported very rarely after vaccination with VAXZEVRIA. Seek immediate medical attention if you develop weakness and paralysis in the extremities that can progress to the chest and face.

Transverse Myelitis (TM) is a neurological disorder where the inflammation of the spinal cord causes weakness in the arms or legs, sensory symptoms (such as tingling, numbness, pain or loss of pain sensation) or problems with bladder or bowel function. This has been reported very rarely after vaccination with VAXZEVRIA. Seek immediate medical attention if you develop weakness, sensory symptoms or problems with bladder or bowel function.

After vaccination, you may have more than one side effect at the same time (for example, muscle/joint aches, headaches, chills and generally feeling unwell). If any of your symptoms are persistent, please seek advice from your healthcare professional.

These are not all the possible side effects you may have when taking VAXZEVRIA. If you experience any side effects not listed here, tell your healthcare professional.

If you experience a severe allergic reaction, call 9-1-1, or go to the nearest hospital.