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Safety information

What you need to know before you or your child receive Bexsero

  • Bexsero is suitable for use in adults and children from 2 months of age
  • To make sure that Bexsero is suitable for you or your child, it is important to tell your doctor, nurse or pharmacist if any of the points below apply to you or your child. If there is anything you do not understand, ask your doctor, nurse or pharmacist to explain.

Do not use Bexsero if:

  • You or your child are allergic to the active substances or any of the other ingredients of this vaccine (listed in section 6 of the Patient information leaflet).

Warnings and precautions

Talk to your doctor, nurse or pharmacist before you or your child receive Bexsero, if you or your child have:

- A severe infection with a high temperature. If this is the case, then vaccination will be postponed. The presence of a minor infection, such as a cold, should not require postponement of the vaccination, but talk to your doctor or nurse first.

- haemophilia or any other problem that may stop your blood from clotting properly, such as treatment with blood thinners (anticoagulants). Talk to your doctor or nurse first.

  • if your child was born prematurely (before or at 28 weeks of pregnancy), particularly if they had breathing difficulties, please tell your doctor. Stopping breathing or irregular breathing for a short time may be more common in the first three days following vaccination in these babies and they may need special monitoring.
  • an allergy to the antibiotic kanamycin. If present, the kanamycin level in the vaccine is low. If you or your child may have allergy to kanamycin, talk to your doctor or nurse first.

Fainting, feeling faint or other stress-related reactions can occur as a response to any needle injection. Tell your doctor or nurse if you have experienced this kind of reaction previously.

Tell your doctor or nurse if you know that you or your child is allergic to latex. The tip cap of the syringe may contain natural rubber latex. The risk for developing an allergic reaction is very small, but your doctor or nurse needs to be aware of your allergy when deciding if you or your child should receive Bexsero.

There are no data on the use of Bexsero in adults above 50 years of age. There are limited data on the use of Bexsero in patients with chronic medical conditions or with weakened immunity. If you or your child have weakened immunity (for example, due to the use of immunosuppressive medications, or HIV infection, or hereditary defects of the body’s natural defence system), it is possible that the effectiveness of Bexsero is reduced.

As with any vaccine, Bexsero may not fully protect all of those who are vaccinated.

Possible side effects

Infants and children (up to 10 years of age)

Very common (these may affect more than 1 in 10 people)

Common (these may affect up to 1 in 10 people)

Uncommon (these may affect up to 1 in 100 people)

Rare (these may affect up to 1 in 1,000 people)

- fever (≥38ºC)

- loss of appetite

- tenderness or discomfort at the injection site (including severe injection site tenderness resulting in crying when injected limb is moved)

- painful joints

- skin rash (children aged 12 to 23 months) (uncommon after booster)

- sleepiness

- feeling irritable

- unusual crying

- vomiting

- diarrhea

- headache

- skin rash (infants and children 2 to 10 years of age)

- high fever (≥40°C)

- seizures (including febrile seizures)

- vomiting (after booster)

- dry skin

- paleness (rare after booster)

- Kawasaki disease which may include symptoms such as fever that lasts for more than five days, associated with a skin rash on the trunk of the body, and sometimes followed by a peeling of the skin on the hands and fingers, swollen glands in the neck, red eyes, lips, throat and tongue 

- Itchy rash, skin rash

Adolescents (from 11 years of age) and adults

Very common (these may affect more than 1 in 10 people)

- pain at the injection site resulting in inability to perform normal daily activity

- painful muscles and joints

- nausea

- generally feeling unwell

- headache

For further information on Bexsero, please refer to the information provided in the Bexsero patient information leaflet (PIL) before vaccination

Bexsero is a registered trademark of the GlaxoSmithKline group of companies.