The safety profile of Comirnaty™ is like that of other vaccines given in New Zealand. Some people experience mild to moderate discomfort at the injection-site and flu-like symptoms (such as headache, muscle and joint aches, fever) for just a day or two after vaccination. These are more commonly reported after the second dose and in younger adults. This is an expected response not experienced by everyone.

Who should this vaccine not be given to?

  • Anyone with severe allergy (anaphylaxis) to a previous dose of this vaccine or a component of the vaccine.
  • Administration of Comirnaty™ should be postponed in individuals with an acute febrile illness (fever over 38°C) or who are systemically unwell. The presence of a minor infection is not a reason to delay immunisation.

Potential responses to Comirnaty

The most common reactions and adverse events after vaccination include, headache, fatigue, muscle aches, nausea and generalised ‘flu-like symptoms.

  • These are the expected responses and were seen in the clinical trials. 
  • Not everyone experiences these responses – they will still be protected by the vaccine.
  • These reactions occur more commonly after the second dose lasting for a day or two.
  • They are more common in people under 50 years
  • Some people (around 1 in 5 people) feel unable to do their normal activities or work the day after vaccination. 
  • Other adverse events reported following vaccination can be associated with stress or anxiety responses to being injected – dizziness, fainting, rapid heartbeat.

Severe allergic reactions (anaphylaxis) can occur almost immediately after any vaccination. (see Anaphylaxis (2.3.2) –[link]

How do risks of contracting COVID-19 disease compare with getting a vaccination?

Risks from COVID-19

Potential responses to mRNA COVID-19 vaccine (Comirnaty)

Two-thirds of people infected with the SARS-CoV-2 virus will have COVID-19 symptoms.

Commonly reported symptoms include:

  • cough
  • fever
  • sore muscles
  • headache
  • shortness of breath
  • sore throat
  • diarrhoea
  • nausea/vomiting.
  • Loss of smell or taste

Common (1 in 4–10 people): usually lasting 1–2 days after vaccination and more common after dose 2:

  • tiredness and lethargy
  • pain at the injection site
  • headache, nausea, dizziness, flu-like illness
  • muscle aches and joint pain
  • chills and fever.

 

Uncommon (1 in 100 to 1 in 1000 people):

  • swollen lymph nodes
  • insomnia
  • itching at injection site

Of those, one in five will have severe disease and need support to breath in hospital.

 

The risk of severe disease increases in people who have underlying health conditions, such as diabetes, heart disease, lung disease, high blood pressure, or are pregnant.

As with any medicine, very rarely, severe allergic reactions occur following immunisation (approximately 5–7 cases per 1 million doses)

Complications include:

  • severe breathing difficulties needing ventilator support
  • infection of the heart and heart failure
  • blood clotting disorders.

 

Around 7-10 cases in 1,000 may die.

 

The likelihood of dying from COVID-19 increases with age. Ranging from:

    • 1 in 10,000 at age 25
    • 4 in 1,000 at age 55
    • 15 in 1,000 at age 65
    • 1 in 20 at age 75
    • 3 in 20 at age 85

 

COVID-19 can be a serious illness in young adults – around one in five who need hospital treatment required intensive care.

 

Long-term complications of the heart, lung and nervous systems have been associated with COVID-19.