Infants And Children (2 months to 10 years of age)

Infants and children (2 months to 10 years of age)

Very common (these may affect more than 1 in 10 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)
  • Skin rash (uncommon after booster)
  • Sleepiness
  • Feeling irritable
  • Unusual crying
  • Vomiting (uncommon after booster)
  • Diarrhea
  • Headache
  • Painful joints

Uncommon (may affect up to 1 in 100 people)

  • High fever (≥40°C)
  • Seizures (including febrile seizures)
  • Vomiting (after booster)
  • Dry skin, itchy rash, skin rash
  • Paleness (rare after booster)
  • Itchy rash, skin rash

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

  • 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.

Your doctor, pharmacist or nurse may ask you to give your child medicines that help lower fever at the time, and after, BEXSERO has been administered. This will help reduce some of the side effects of BEXSERO.

Side effects that have been reported since the vaccine has been on the market include:

Allergic reactions may include severe swelling of the lips, mouth, throat (which may cause difficulty in swallowing), difficulty breathing with wheezing or coughing, rash, loss of consciousness and very low blood pressure; collapse (sudden onset of muscle floppiness), less responsive than usual or lack of awareness, and paleness or bluish skin discoloration in young children; feeling faint or fainting; fever (adolescents from 11 years of age and adults); injection site reactions like extensive swelling of the vaccinated limb, blisters at or around the injection site and hard lump at the injection site (which may persist for more than one month).

If any of the noted side effects become serious, or if you notice any side effects not listed here, please tell your doctor, pharmacist, or nurse immediately. This is not a complete list of side effects. For any unexpected effects while taking BEXSERO, contact your doctor, pharmacist, or nurse. If you need to report an adverse event, please call 1-800-387-7374.

Warnings and precautions

BEFORE your child receives BEXSERO, talk to your doctor, pharmacist, or nurse if:

  • They have a severe infection with a high temperature. If so, 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, pharmacist, or nurse first.
  • If they receive treatment that blocks the part of the immune system known as complement activation, such as eculizumab. Even if they have been vaccinated with BEXSERO they remain at increased risk of disease caused by the Neisseria meningitidis group B bacteria.
  • They have hemophilia or any other condition that may slow down the clotting of the blood, such as treatment with blood thinners (anticoagulants).
  • They were born prematurely (before or at 28 weeks of pregnancy), particularly with breathing difficulties. 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.
  • They have an allergy to the antibiotic kanamycin. If present, the kanamycin level in the vaccine is low. If your child may have an allergy to kanamycin, talk to your doctor, pharmacist, or nurse first.
  • They are allergic to latex. The tip cap of the syringe may contain natural rubber latex. Although the risk for developing allergic reactions is very small, your doctor/pharmacist/nurse should consider the benefit-risk prior to administering this vaccine to subjects with known history of hypersensitivity to latex.

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

BEXSERO should not be used if your child is allergic (hypersensitive) to the active substances or any of the other components of the vaccine closure of BEXSERO. If your child has a weakened immune 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. Additionally, BEXSERO is not expected to protect against all circulating meningococcal serogroup B strains and doesn’t offer protection against strains A, C, Y and W-135. BEXSERO does not treat or reduce the consequences of meningococcal disease, including meningitis, sepsis, and death.

BEXSERO is a vaccine for the prevention of meningococcal disease caused by Neisseria meningitidis group B bacteria in individuals from 2 months through 25 years of age.