Fluzone Quadrivalent 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 Quadrivalent.
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
- What flu vaccine can I use with an egg allergy?
- How and where is a flu shot injection given?
- How well does the flu vaccine work?
- How can I get a flu vaccine without a needle?
- Where can I get the flu vaccine right now?
More about Fluzone Quadrivalent (influenza virus vaccine, inactivated)
- Check interactions
- Compare alternatives
- Reviews (3)
- Side effects
- Dosage information
- During pregnancy
- Drug class: viral vaccines
Patient resources
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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.