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Fluzone Intradermal Side Effects

Generic Name: influenza virus vaccine, inactivated

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

Not all side effects for Fluzone Intradermal may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to influenza virus vaccine, inactivated: intramuscular solution

Other dosage forms:

In addition to its needed effects, some unwanted effects may be caused by influenza virus vaccine, inactivated (the active ingredient contained in Fluzone Intradermal). In the event that any of these side effects do occur, they may require medical attention.

If any of the following side effects occur while taking influenza virus vaccine, inactivated, check with your doctor or nurse immediately:

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 of the side effects that can occur with influenza virus vaccine, inactivated may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

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. FluMist Quadrivalent (influenza virus vaccine, live)." AstraZeneca Pharma Inc, Mississauga, IA.

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

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

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

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

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

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

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

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

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

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

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

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

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

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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