Trumenba Side Effects

Generic name: meningococcal group B vaccine

Medically reviewed by Drugs.com. Last updated on Feb 13, 2024.

Note: This document provides detailed information about Trumenba Side Effects associated with meningococcal group B vaccine. Some dosage forms listed on this page may not apply specifically to the brand name Trumenba.

Applies to meningococcal group B vaccine: intramuscular suspension.

Important warnings This medicine can cause some serious health issues

You should not receive the vaccine a second time if you had a life threatening allergic reaction after the first shot.

Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.

Keep track of all side effects you have. If you need a booster dose, you will need to tell the vaccination provider if the previous shot caused any side effects.

You should not receive a second shot if you had a life-threatening allergic reaction after the first shot.

Becoming infected with meningococcal disease and developing meningitis is much more dangerous to your health than receiving this vaccine. Any vaccine may cause side effects but the risk of serious side effects is low.

You may feel faint after receiving this vaccine. Your doctor may want you to remain under observation during the first 15 minutes after the injection.

Common side effects may include:

• headache;

• feeling tired, chills;

• muscle or joint pain;

• nausea, diarrhea; or

• pain, redness, swelling, or a hard lump where the shot was given.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For healthcare professionals

Applies to meningococcal group B vaccine: intramuscular suspension.

General adverse events

The most common adverse events were injection site pain, fever, headache, fatigue and myalgia.^[Ref]

Cardiovascular

• Uncommon (0.1% to 1%): Pallor (rare after booster)
• Rare (0.01% to 0.1%): Kawasaki syndrome^[Ref]

Dermatologic

• Very common (10% or more): Rash, redness/erythema
• Common (1% to 10%): Eczema
• Rare (0.01% to 0.1%): Urticaria^[Ref]

Rash was very commonly reported in patients 12 to 23 months of age but was reported as an uncommon side effect in this age group when they received a booster dose. Rash was commonly reported in patients 2 to 10 years of age.^[Ref]

Local

• Very common (10% or more): Injection site pain (up to 92.6%), injection site swelling (up to 27.4%), injection site redness/erythema (up to 24.1%), severe injection site pain (up to 11%), injection site tenderness, injection site induration
• Common (1% to 10%): Severe injection site erythema, severe injection site induration, severe injection site swelling
• Frequency not reported: Blisters at or around injection site, extensive swelling of the vaccinated limb, injection site nodule, injection site reactions^[Ref]

Injection site nodules have persisted for over 1 month.

Injection site tenderness was classified as crying when the injected limb was moved.

Severe injection site erythema, severe injection site induration, and severe injection site swelling were classified as conditions that resulted in patients unable to perform normal, daily activity.^[Ref]

Gastrointestinal

• Very common (10% or more): Diarrhea (up to 19.5%), nausea (up to 13%)
• Common (1% to 10%): Vomiting (uncommon after booster)
• Uncommon (0.1% to 1%): Severe nausea^[Ref]

Severe nausea was classified as nausea that resulted in patients unable to perform normal, daily activity.^[Ref]

Hematologic

• Frequency not reported: Lymphadenopathy^[Ref]

Hypersensitivity

• Frequency not reported: Allergic reactions, anaphylactic reactions
• Postmarketing reports: Hypersensitivity reactions^[Ref]

Metabolic

• Very common (10% or more): Eating disorders^[Ref]

Musculoskeletal

• Very common (10% or more): Muscle pain/myalgia (up to 75%), chills (36.3%), joint pain/arthralgia (up to 33.3%)
• Uncommon (0.1% to 1%): Severe arthralgia, severe myalgia
• Frequency not reported: Neck stiffness^[Ref]

Severe arthralgia and severe myalgia were classified as conditions that resulted in patients unable to perform normal, daily activity.^[Ref]

Nervous system

• Very common (10% or more): Headache (up to 67.1%), sleepiness
• Common (1% to 10%): Severe headache
• Uncommon (0.1% to 1%): Seizures (including febrile seizures)
• Frequency not reported: Hypotonic-hyporesponsive episode, meningeal irritation/signs of meningeal irritation, syncope, vasovagal responses to injection^[Ref]

Severe headache was classified as headache that resulted in patients unable to perform normal, daily activity.

Signs of meningeal irritation (e.g., neck stiffness, photophobia) occurred sporadically and were transient and mild when reported after vaccination.^[Ref]

Ocular

• Frequency not reported: Photophobia
• Postmarketing reports: Eye swelling^[Ref]

Other

• Very common (10% or more): Fever of at least 38C (up to 74%), fatigue (up to 65.5%), malaise (up to 58%), use of antipyretic medication (up to 20.7%)
• Common (1% to 10%): Fever
• Uncommon (0.1% to 1%): Severe fatigue, severe fever (at least 40C)^[Ref]

In a trial with 115 subjects, fever was reported in 74% of patients 2 to 12 months of age and occurred in 69% of patients 6 to 12 months of age.

Severe fatigue and severe fever were classified as conditions that resulted in patients unable to perform normal, daily activity.^[Ref]

Psychiatric

• Very common (10% or more): Irritability, unusual crying^[Ref]

Further information

Trumenba side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer