Note: This document contains side effect information about influenza virus vaccine, inactivated. Some dosage forms listed on this page may not apply to the brand name FluLaval Preservative-Free Quadrivalent.

Applies to influenza virus vaccine, inactivated: intramuscular emulsion. Other dosage forms:

• intramuscular solution
• suspension

Serious side effects

Along with its needed effects, influenza virus vaccine, inactivated (the active ingredient contained in FluLaval Preservative-Free Quadrivalent) 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 influenza virus vaccine, inactivated:

Less common

• Fever or chills

Incidence not known

• Black, tarry stools
• bleeding gums
• blood in the urine or stools
• cough
• difficulty swallowing
• dizziness
• fainting
• fast heartbeat
• hives, itching, or rash
• inability to move the arms and legs
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• pinpoint red spots on the skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• sudden numbness and weakness in the arms and legs
• tightness in the chest
• unusual bleeding or bruising
• unusual tiredness or weakness

Other side effects

Some side effects of influenza virus vaccine, inactivated 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

• Headache
• joint or muscle pain
• pain at the injection site

Less common

• Diarrhea
• loss of appetite
• nausea or vomiting
• redness or swelling at the injection site

For Healthcare Professionals

Applies to influenza virus vaccine, inactivated: intradermal suspension, intramuscular solution, intramuscular suspension, nasal spray.

General

The most common adverse events were local reactions, myalgia, and headache.^[Ref]

Local

Very common (10% or more): Tenderness (89%), erythema/redness (76.4%), pain (73.8%), induration (58.4%), swelling (56.8%), injection-site pruritus (46.9%), itching (28%), bruising (18%), injection-site ecchymosis (14.9%), mass (11%)

Common (1% to 10%): Reaction, hemorrhage

Postmarketing reports: Cellulitis, injection site inflammation, injection site sterile abscess^[Ref]

Other

Very common (10% or more): Crying abnormal (41.2%), malaise (38%), fever (16%)

Common (1% to 10%): Chest tightness

Rare (less than 0.1%): Death

Postmarketing reports: Hot flashes/flushes^[Ref]

Musculoskeletal

Very common (10% or more): Myalgia (40%)

Common (1% to 10%): Chills/shivering, back pain

Postmarketing reports: Muscle weakness, arthritis, arthralgia, myasthenia^[Ref]

Nervous system

Very common (10% or more): Headache (40%), drowsiness (37.7%), lethargy (14%)

Common (1% to 10%): Migraine

Postmarketing reports: Neuralgia, paresthesia, convulsions (including febrile seizures), encephalopathy, neuritis or neuropathy, transverse myelitis, Guillain-Barre syndrome, abnormal gait, dizziness, hypoesthesia, hypokinesia, tremor, somnolence, syncope, facial or cranial nerve paralysis, encephalopathy, limb paralysis, confusion, paralysis (including Bell's Palsy), vertigo, exacerbation of symptoms of mitochondrial encephalomyopathy (Leigh syndrome), meningitis, eosinophilic meningitis, vaccine-associated encephalitis^[Ref]

Respiratory

Very common (10% or more): Runny nose/nasal congestion (58%), cough (15%), upper respiratory tract infection (13%)

Common (1% to 10%): Sore throat, cough, oropharyngeal pain, rhinorrhea, wheezing, pharyngolaryngeal pain, nasopharyngitis

Postmarketing reports: Rhinitis, laryngitis, dyspnea, dysphonia, bronchospasm, throat tightness, pharyngitis, epistaxis^[Ref]

Gastrointestinal

Very common (10% or more): Vomiting (15%), nausea (14.9%) diarrhea (13%)

Postmarketing reports: Dysphagia, abdominal pain, swelling of the mouth, throat, and/or tongue^[Ref]

Metabolic

Very common (10% or more): Loss of appetite (33.3%), decreased appetite (21%)^[Ref]

Psychiatric

Very common (10% or more): Irritability (54%)

Postmarketing reports: Insomnia^[Ref]

Hypersensitivity

Postmarketing reports: Allergic reactions including anaphylactic shock, serum sickness, and death; Stevens-Johnson syndrome^[Ref]

Immunologic

Common (1% to 10%): Infection, influenza-like illness

Postmarketing reports: Cellulitis^[Ref]

Dermatologic

Common (1% to 10%): Facial swelling

Postmarketing reports: Pruritus, urticaria, rash, angioedema, sweating, flushing, pallor, rash, erythema multiforme^[Ref]

Ocular

Common (1% to 10%): Reddened eyes

Postmarketing reports: Eye pain, photophobia, conjunctivitis, eye irritation, eye swelling, eyelid swelling, ocular hyperemia^[Ref]

Hematologic

Postmarketing reports: Transient thrombocytopenia, lymphadenopathy^[Ref]

Cardiovascular

Frequency not reported: Pleuropericarditis with effusions

Postmarketing reports: Tachycardia, pericarditis, vasculitis, vasodilation/flushing^[Ref]

Renal

Postmarketing reports: Vasculitis with transient renal involvement^[Ref]

Genitourinary

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