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Fluzone High-Dose Side Effects

Generic name: influenza virus vaccine, inactivated

Medically reviewed by Drugs.com. Last updated on Feb 2, 2024.

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 Fluzone High-Dose.

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]

Frequently asked questions

References

1. Cerner Multum, Inc. UK Summary of Product Characteristics.

2. Cerner Multum, Inc. Australian Product Information.

3. Product Information. Agriflu (influenza virus vaccine, inactivated). Novartis Pharmaceuticals. 2015.

4. Product Information. Fluzone High-Dose 2015-2016 (influenza virus vaccine, inactivated). sanofi pasteur. 2015.

5. Product Information. Fluzone Intradermal 2014-2015 (influenza virus vaccine, inactivated). sanofi pasteur. 2015.

6. Product Information. Flucelvax 2015-2016 (influenza virus vaccine, inactivated). Novartis Vaccines & Diagnostics Inc. 2015.

7. Product Information. Flublok 2015-2016 (influenza virus vaccine, inactivated). Protein Sciences Corporation. 2015.

8. Product Information. Fluarix Quadrivalent 2015-2016 (influenza virus vaccine, inactivated). GlaxoSmithKline. 2015.

9. Product Information. Fluzone Quadrivalent (influenza virus vaccine, inactivated). Sanofi Pasteur Limited. 2015.

10. Product Information. FluLaval Quadrivalent 2015-2016 (influenza virus vaccine, inactivated). GlaxoSmithKline. 2015.

11. Product Information. Afluria 2015-2016 (influenza virus vaccine, inactivated). bioCSL Inc. 2015.

12. Product Information. FluLaval 2014-2015 (influenza virus vaccine, inactivated). GlaxoSmithKline. 2015.

13. Product Information. Fluarix 2014-2015 (influenza virus vaccine, inactivated). GlaxoSmithKline. 2015.

14. Product Information. Fluvirin 2015-2016 (influenza virus vaccine, inactivated). Novartis Vaccines & Diagnostics Inc. 2015.

15. Product Information. Fluzone (influenza virus vaccine, inactivated). Connaught Laboratories Inc.

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.