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Meningococcal polysaccharide vaccine Side Effects

For the Consumer

Applies to meningococcal polysaccharide vaccine: parenteral for injection for sub-q use, parenteral solution for im use

Side effects include:

MenACWY-D (Menactra®): Injection site reactions (e.g., pain, induration, erythema, swelling), headache, fatigue, malaise, arthralgia, diarrhea, anorexia, chills, fever, vomiting, rash.

MenACWY-CRM (Menveo®): Injection site reactions (tenderness, erythema), irritability, sleepiness, persistent crying, change in eating habits, vomiting, diarrhea in infants 2 through 23 months of age; injection site reactions (pain, erythema, induration), irritability, sleepiness, malaise, headache in children 2 through 10 years of age; injection site pain, headache, myalgia, malaise, nausea in adults and adolescents.

MPSV4 (Menomune®): Injection site reactions (e.g., pain, erythema, induration, swelling), headache, malaise, chills, fever.

Hib-MenCY (MenHibrix®): Injection site reactions (e.g., pain, redness, swelling), systemic effects (e.g., fever, irritability, drowsiness, loss of appetite).

For Healthcare Professionals

Applies to meningococcal polysaccharide vaccine: subcutaneous powder for injection

General

The most common adverse events were injection site pain, headache, irritability, and diarrhea.[Ref]

Local

Very common (10% or more): Injection site pain (48.1%), injection site redness (16%), injection site induration (11%), injection site tenderness

Common (1% to 10%): Injection site swelling, injection site hematoma

Uncommon (0.1% to 1%): Injection site reaction

Rare (less than 0.1%): Severe local reactions

Postmarketing reports: Extensive limb swelling at the injection site (frequently associated with erythema, sometimes involving the adjacent joint or swelling of the entire injected limb)[Ref]

Nervous system

Very common (10% or more): Headache (41.8%), drowsiness (11.2%)

Uncommon (0.1% to 1%): Hypoesthesia, dizziness

Very rare (less than 0.01%): Somnolence, neurological reactions

Postmarketing reports: Vasovagal syncope, paresthesia, Guillain-Barre syndrome[Ref]

Other

Very common (10% or more): Fatigue (32.3%), malaise (22.3%), fever

Common (1% to 10%): Chills, febrile reactions (>38C)

Postmarketing reports: Asthenia, influenza-like symptoms[Ref]

Psychiatric

Very common (10% or more): Irritability (12.2%)

Uncommon (0.1% to 1%): Insomnia, crying[Ref]

Musculoskeletal

Very common (10% or more): Arthralgia (16%)

Uncommon (0.1% to 1%): Myalgia, pain in extremity

Postmarketing reports: Musculoskeletal stiffness[Ref]

Metabolic

Very common (10% or more): Appetite lost

Common (1% to 10%): Anorexia

Postmarketing reports: Decreased appetite[Ref]

Gastrointestinal

Very common (10% or more): Diarrhea (14%)

Common (1% to 10%): Vomiting, nausea[Ref]

Dermatologic

Common (1% to 10%): Rash

Uncommon (0.1% to 1%): Pruritus

Rare (less than 0.1%): Urticaria, angioedema

Postmarketing reports: Angioneurotic edema[Ref]

Hematologic

Very common (10% or more): Local axillary lymphadenopathy[Ref]

Hypersensitivity

Postmarketing reports: Hypersensitivity (such as rash, urticaria, pruritus, dyspnea, angioedema), allergic reactions (including anaphylactic and anaphylactoid reactions)[Ref]

Respiratory

Uncommon (0.1% to 1%): Upper respiratory tract illness

Rare (less than 0.1%): Wheeze[Ref]

Renal

Postmarketing reports: IgA nephropathy[Ref]

References

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

2. Cerner Multum, Inc. "Australian Product Information." O 0

3. "Product Information. Menomune (meningococcal polysaccharide vaccine)." Sanofi Pasteur, Toronto, IA.

Further information

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.

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