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Meningococcal group B vaccine Side Effects

For the Consumer

Applies to meningococcal group B vaccine: intramuscular suspension prefilled syringe

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Shortness of breath.
  • Very bad dizziness or passing out.

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Pain where the shot was given.
  • Irritation where the shot is given.
  • Feeling tired or weak.
  • Headache.
  • Muscle or joint pain.
  • Chills.
  • Loose stools (diarrhea).
  • Upset stomach.
  • Fever.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

For Healthcare Professionals

Applies to meningococcal group B vaccine: intramuscular suspension

General

The most common adverse events were pain at the injection site, fatigue, erythema, myalgia, headache, and induration.[Ref]

Local

Very common (10% or more): Injection site pain (92.8%), erythema (50%), induration (32%), swelling (21.6%)
Postmarketing reports: Blisters at or around injection site[Ref]

Nervous system

Very common (10% or more): Fatigue (64.4%), headache (56.9%), sleepiness, unusual crying
Uncommon (0.1% to 1%): Seizures (including febrile seizures)
Postmarketing reports: Syncope, vasovagal responses to injection[Ref]

Musculoskeletal

Very common (10% or more): Myalgia (49%), chills (30.3%), arthralgia (21.6%)[Ref]

Gastrointestinal

Very common (10% or more): Nausea (19%), diarrhea (15.2%)
Common (1% to 10%): Vomiting[Ref]

Psychiatric

Very common (10% or more): Irritability[Ref]

Metabolic

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

Other

Common (1% to 10%): Fever[Ref]

Dermatologic

Common (1% to 10%): Rash
Uncommon (0.1% to 1%): Eczema
Rare (less than 0.1%): Urticaria[Ref]

Cardiovascular

Uncommon (0.1% to 1%): Pallor (rare after booster)
Rare (less than 0.1%): Kawasaki syndrome[Ref]

Hypersensitivity

Very rare (less than 0.01%): Anaphylaxis
Postmarketing reports: Allergic reactions, rash, eye swelling[Ref]

Respiratory

Frequency not reported: Nasopharyngitis[Ref]

References

1. "Product Information. Trumenba (meningococcal group B vaccine)." Pfizer U.S. Pharmaceuticals Group, New York, NY.

2. "Product Information. Bexsero (meningococcal group B vaccine)." Novartis Vaccines & Diagnostics Inc, Cambridge, MA.

3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

Some side effects of meningococcal group B vaccine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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