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Afluria Side Effects

Generic Name: influenza virus vaccine, inactivated

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

For the Consumer

Applies to influenza virus vaccine, inactivated: intramuscular solution

Other dosage forms:

Along with its needed effects, influenza virus vaccine, inactivated (the active ingredient contained in Afluria) 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:

Incidence not known

  • Cough
  • difficulty with swallowing
  • dizziness
  • fast heartbeat
  • hives, itching, or skin rash
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • tightness in the chest
  • unusual tiredness or weakness

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

  • Difficulty with moving
  • headache
  • joint pain
  • muscle aching or cramping
  • muscle pains or stiffness
  • nausea
  • pain at the injection site
  • swollen joints

Less common

  • Chills
  • redness, bruising, 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]

References

1. "Product Information. Fluarix 2014-2015 (influenza virus vaccine, inactivated)." GlaxoSmithKline, Research Triangle Park, NC.

2. "Product Information. FluLaval Quadrivalent 2015-2016 (influenza virus vaccine, inactivated)." GlaxoSmithKline, Research Triangle Park, NC.

3. "Product Information. Agriflu (influenza virus vaccine, inactivated)." Novartis Pharmaceuticals, East Hanover, NJ.

4. "Product Information. Flucelvax 2015-2016 (influenza virus vaccine, inactivated)." Novartis Vaccines & Diagnostics Inc, Cambridge, MA.

5. "Product Information. Fluarix Quadrivalent 2015-2016 (influenza virus vaccine, inactivated)." GlaxoSmithKline, Research Triangle Park, NC.

6. "Product Information. Afluria 2015-2016 (influenza virus vaccine, inactivated)." bioCSL Inc, King of Prussia, PA.

7. "Product Information. Fluvirin 2015-2016 (influenza virus vaccine, inactivated)." Novartis Vaccines & Diagnostics Inc, Cambridge, MA.

8. "Product Information. Fluzone Quadrivalent (influenza virus vaccine, inactivated)." Sanofi Pasteur, Toronto, IA.

9. "Product Information. Fluzone High-Dose 2015-2016 (influenza virus vaccine, inactivated)." sanofi pasteur, Swiftwater, PA.

10. "Product Information. Flublok 2015-2016 (influenza virus vaccine, inactivated)." Protein Sciences Corporation, Meriden, CT.

11. "Product Information. FluLaval 2014-2015 (influenza virus vaccine, inactivated)." GlaxoSmithKline, Research Triangle Park, NC.

12. "Product Information. Fluzone Intradermal 2014-2015 (influenza virus vaccine, inactivated)." sanofi pasteur, Swiftwater, PA.

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

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

15. "Product Information. Fluzone Influenza Vaccine (influenza virus vaccine)." Connaught, Swiftwater, PA.

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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