Note: This document contains side effect information about meningococcal conjugate vaccine. Some dosage forms listed on this page may not apply to the brand name MenQuadfi.

Applies to meningococcal conjugate vaccine: intramuscular solution. Other dosage forms:

• intramuscular suspension

Serious side effects of MenQuadfi

Along with its needed effects, meningococcal conjugate vaccine (the active ingredient contained in MenQuadfi) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking meningococcal conjugate vaccine:

Rare

• Fainting

Incidence not known

• Fast heartbeat
• fever
• hives, itching, skin rash
• hoarseness
• irritation
• joint pain, stiffness, or swelling
• redness of the skin
• swelling of the eyelids, face, lips, hands, or feet
• tightness in the chest
• troubled breathing or swallowing

Other side effects of MenQuadfi

Some side effects of meningococcal conjugate vaccine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Difficulty in moving
• general feeling of discomfort or illness
• headache
• muscle pain
• pain, redness, or swelling at the injection site
• unusual tiredness or weakness

Rare

• Dizziness

For Healthcare Professionals

Applies to meningococcal conjugate vaccine: intramuscular powder for injection, intramuscular solution.

General

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

Local

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

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

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

Postmarketing reports: Injection site reaction, injection site cellulitis, extensive swelling of the injected limb (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%): Dizziness, hypoesthesia

Postmarketing reports: Vasovagal syncope, paresthesia, Guillain-Barre syndrome, vertigo, tonic convulsion, febrile convulsion, vertigo, vestibular disorder, syncope, facial paresis, balance disorder^[Ref]

Gastrointestinal

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

Common (1% to 10%): Vomiting, gastrointestinal symptoms^[Ref]

Other

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

Common (1% to 10%): Chills, crying

Postmarketing reports: Asthenia, impaired hearing, ear pain, fall, head injury, body temperature increased^[Ref]

Dermatologic

Common (1% to 10%): Rash

Uncommon (0.1% to 1%): Pruritus

Postmarketing reports: Bullous conditions^[Ref]

Musculoskeletal

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

Uncommon (0.1% to 1%): Pain in extremity

Postmarketing reports: Bone pain^[Ref]

Psychiatric

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

Common (1% to 10%): Insomnia^[Ref]

Metabolic

Very common (10% or more): Appetite lost

Common (1% to 10%): Anorexia, eating disorder^[Ref]

Respiratory

Uncommon (0.1% to 1%): Nasopharyngitis

Postmarketing reports: Oropharyngeal pain^[Ref]

Hypersensitivity

Postmarketing reports: Hypersensitivity (such as rash, urticaria, pruritus, dyspnea, angioedema) including anaphylaxis^[Ref]

Hepatic

Postmarketing reports: Alanine aminotransferase increased^[Ref]

Ocular

Postmarketing reports: Eyelid ptosis^[Ref]